Thomson Innovation Patent Export2015-04-20 13:27:21 -0500
Table of Contents
1US6290681B1Flow monitoring device for medical application
2US5488368AA/D converter system and method with temperature compensation
3US5131816ACartridge fed programmable ambulatory infusion pumps powered by DC electric motors
4US4950255ACatheter connector and clamp
5US4759527AInfusion pump valve
6US4741736AProgrammable infusion pump
7US4701159AMultilumen catheter set
8US4695273AMultiple needle holder and subcutaneous multiple channel infusion port
9US4687475AMethod for sequential intravenous infusion of multiple fluids
10US4604093AApparatus and method for administering multiple fluid infusions
11EP1034734A1Method for improving patient compliance with a medical program | Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten | Procédé servant à améliorer la conformité d'un patient à un programme médical
12WO2001074229A2APPARATUS AND METHOD FOR IMPROVING PATIENT COMPLIANCE WITH A MEDICAL PROGRAM | APPAREIL ET PROCEDE PERMETTANT A UN PATIENT DE MIEUX RESPECTER UN PROGRAMME MEDICAL
13WO2000002478A3HYDRAULIC SURGICAL SYSTEM | SYSTEME CHIRURGICAL HYDRAULIQUE
14CA1264261CMULTIPLE NEEDLE HOLDER AND SUBCUTANOEUS MULTIPLE CHANNEL INFUSION PORT | PORTE-AIGUILLES ET APPAREIL D'INJECTION SOUS-CUTANEE A PLUSIEURS VOIES
15US20030046090A1Personalized health video system
16US5445622AFlow switch device for medical applications
17US5359327AA/D converter system with interface and passive voltage reference source
18US5011378APump tube mount and cartridge for infusion pump
19US4950245AMultiple fluid cartridge and pump
20EP354324A3CARTRIDGE-TYPE PROGRAMMABLE AMBULATORY INFUSION PUMP | Pompe à perfusion programmable et portable fonctionnant avec des cartouches | Mit Kassette verwendbare, programmierbare und tragbare Infusionspumpe
21EP354324A2Cartridge-type programmable ambulatory infusion pump. | Mit Kassette verwendbare, programmierbare und tragbare Infusionspumpe. | Pompe à perfusion programmable et portable fonctionnant avec des cartouches. | Cartridge-type programmable ambulatory infusion pump | Mit Kassette verwendbare, programmierbare und tragbare Infusionspumpe | Pompe a perfusion programmable et portable fonctionnant avec des cartouches
22JP4082564AINJECTION PUMP DEVICE
23EP340427A3CATHETER CONNECTOR AND CLAMP | Raccord pour cathéter et clamp | Katheter-Verbindungsstück und-Klemme
24EP340427A2Catheter connector and clamp. | Katheter-Verbindungsstück und -Klemme. | Raccord pour cathéter et clamp. | Catheter connector and clamp | Katheter-Verbindungsstueck und -Klemme | Raccord pour catheter et clamp
25JP2029270ACONNECTOR FOR CATHETER
26US4666430AInfusion pump
27US4581012AMultilumen catheter set
28EP185977A1Multilumen catheter set. | Mehrlumeniger Katheteransatz. | Set pour cathéter à lumières multiples. | Multilumen catheter set | Set pour cathéter à lumières multiples | Mehrlumeniger Katheteransatz
29EP241159A3MULTIPLE NEEDLE HOLDER AND SUBCUTANEOUS MULTIPLE CHANNEL INFUSION PORT | Support pour plusieurs aiguilles et site d'injection sous-cutanée à canaux multiples | Mehrfach-Nadelträger und subkutaner Injektionskopf mit mehreren Durchlasskanälen
30EP241159A2Multiple needle holder and subcutaneous multiple channel infusion port. | Mehrfach-Nadelträger und subkutaner Injektionskopf mit mehreren Durchlasskanälen. | Support pour plusieurs aiguilles et site d'injection sous-cutanée à canaux multiples. | Multiple needle holder and subcutaneous multiple channel infusion port | Mehrfach-Nadeltraeger und subkutaner Injektionskopf mit mehreren Durchlasskanaelen | Support pour plusieurs aiguilles et site d'injection sous-cutanee a canaux multiples
31CA1264261A1MULTIPLE NEEDLE HOLDER AND SUBCUTANOEUS MULTIPLE CHANNEL INFUSION PORT | PORTE-AIGUILLES ET APPAREIL D'INJECTION SOUS-CUTANEE A PLUSIEURS VOIES
32JP62240069AMULTINEEDLE HOLDER AND MULTIPLE FLOW CHANNEL TYPE INJECTION PORT APPARATUS
33EP182900A1METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS. | VERFAHREN ZUR AUFEINANDERFOLGENDEN INTRAVENÖSEN INFUSION MEHRERER FLÜSSIGKEITEN. | PROCEDE DE PERFUSION INTRAVEINEUSE SEQUENTIELLE DE FLUIDES MULTIPLES. | METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS | PROCEDE DE PERFUSION INTRAVEINEUSE SEQUENTIELLE DE FLUIDES MULTIPLES | VERFAHREN ZUR AUFEINANDERFOLGENDEN INTRAVENÖSEN INFUSION MEHRERER FLÜSSIGKEITEN
34WO1986000022A1METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS | PROCEDE DE PERFUSION INTRAVEINEUSE SEQUENTIELLE DE FLUIDES MULTIPLES
35AU198544965AMETHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS
36TW537880BMethod for improving patient compliance with a medical program
37JP2000316820AMETHOD FOR IMPROVING COMPLIANCE OF PATIENT WITH MEDICAL PROGRAM
38US20040015132A1Method for improving patient compliance with a medical program
39US20020055892A1Personalized sales video system
40AU200118183AApparatus and method for improving patient compliance with a medical program
41WO2001074229A3IMPROVING PATIENT COMPLIANCE WITH A MEDICAL PROGRAM | APPAREIL ET PROCEDE PERMETTANT A UN PATIENT DE MIEUX RESPECTER UN PROGRAMME MEDICAL
42WO2000002478A2HYDRAULIC SURGICAL SYSTEM | SYSTEME CHIRURGICAL HYDRAULIQUE
43AU199949792AHydraulic surgical system
Record 1/43
US6290681B1Flow monitoring device for medical application
Publication Number: US6290681B1  
Title: Flow monitoring device for medical application
Title (Original): Flow monitoring device for medical application
Title (English): Flow monitoring device for medical application
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Fluid flow monitoring device for intravenous fluid, comprises transparent fluid conducting mechanism enclosing a movable stem body, and signal emitter-sensor arrangement
Abstract:


An intravenous system for monitoring the flow of IV fluids to a patient is embodied in a wristwatch sized case for placement on the patient. The device includes a switch uses capable of detecting when flow starts or stops. In one embodiment, the range of flow rates which may trigger a signal is increased using a plurality of sensor elements. The flow indicator switch uses a conical fluid conducting means with a movable stem body which reacts to the motion of the IV fluid. A signal-emitter-sensor arrangement provides a means for converting physical displacement into an electrical signal indicating displacement of the movable member thus detecting when flow starts and stops, as well as the rate of flow. Collected information is stored in a data storage means and may be either displayed on a display means housed within the case, or alternately, the collected data may be uploaded to a computer.
Abstract (English):

An intravenous system for monitoring the flow of IV fluids to a patient is embodied in a wristwatch sized case for placement on the patient. The device includes a switch uses capable of detecting when flow starts or stops. In one embodiment, the range of flow rates which may trigger a signal is increased using a plurality of sensor elements. The flow indicator switch uses a conical fluid conducting means with a movable stem body which reacts to the motion of the IV fluid. A signal-emitter-sensor arrangement provides a means for converting physical displacement into an electrical signal indicating displacement of the movable member thus detecting when flow starts and stops, as well as the rate of flow. Collected information is stored in a data storage means and may be either displayed on a display means housed within the case, or alternately, the collected data may be uploaded to a computer.
Abstract (French):
Abstract (German):
Abstract (Original):

An intravenous system for monitoring the flow of IV fluids to a patient is embodied in a wristwatch sized case for placement on the patient. The device includes a switch uses capable of detecting when flow starts or stops. In one embodiment, the range of flow rates which may trigger a signal is increased using a plurality of sensor elements. The flow indicator switch uses a conical fluid conducting means with a movable stem body which reacts to the motion of the IV fluid. A signal-emitter-sensor arrangement provides a means for converting physical displacement into an electrical signal indicating displacement of the movable member thus detecting when flow starts and stops, as well as the rate of flow. Collected information is stored in a data storage means and may be either displayed on a display means housed within the case, or alternately, the collected data may be uploaded to a computer.
Abstract (Spanish):
Claims:

What is claimed is:
1. A fluid flow monitoring device comprising:
a transparent fluid conducting means enclosing a stem body movable along the fluid conducting means and biased against a proximal interior shoulder of the fluid conducting means, said shoulder defining a fluid inlet; and
a signal emitter-sensor means positioned externally to the fluid conducting means for transmitting a signal across the fluid conducting means from an emitter of the emitter-sensor means, to a sensor of the emitter-sensor means, such that with the stem body in a first stem body position within the fluid conducting means, the signal is blocked, and with the stem body in a second stem body position within the fluid conducting means, the signal is not blocked, said second stem body position adapted by the stem body as a result of a fluid flow within the conducting means wherein the fluid flow is sensed by the emitter-sensor means as the stem body moves.
2. The device of claim 1 further including a masking means interposed between the emitter-sensor means and the stem body, the masking means adapted for focusing the signal.
3. The device of claim 1 wherein the fluid conducting means is of a conical shape oriented such that resistance to the fluid flow by the stem body when in the second position is less then when in the first position.
4. The device of claim 1 further including a processor circuit in communication with the signal emitter-sensor means, and comprising a processor means, a clock means, a data storage means, a visual display means, and an alerting means, all interconnected, so as to enable the circuit to identify a time data, and display a fluid flow state, type of medication scheduled, and time of next scheduled medication.
5. The device of claim 4 further including parameter measuring instrument signal receiving means.
6. The device of claim 4 further including a communication means interconnecting the processor circuit with a computer, the computer being programmed to record and display data.
7. The device of claim 6 wherein the communication means is at least one electrically conducting path.
8. The device of claim 6 wherein the communication means is a wireless device.
9. The device of claim 4 further including an alerting means for signaling a user when recorded data corresponds with preprogrammed data.
10. The device of claim 9 wherein the alerting means produces an audible noise.
11. The device of claim 9 wherein the alerting means produces a mechanical vibration.
12. The device of claim 1 wherein the stem body has a circular cross-section with one end thereof providing a generally flat surface, said surface not forming a tight seal when in contact with the proximal shoulder.
13. The device of claim 12 further including a wristwatch size case encompassing the processor circuit, said case positionable for viewing and further including a fluid inlet conducting means, and a fluid outlet conducting means.
14. The device of claim 1 wherein the signal emitter-sensor means comprises a linear sequence of independent sensors, movement of the stem body blocking at least one of said sensors, such that the position of the stem body is known at each position of the stem body within the conducting means.
15. The device of claim 1 wherein the stem body includes a generally circular outside surface, the surface providing a plurality of fluidic pathways for conducting the fluid between the stem body and the conical wall of the conducting means providing improved conductance of the fluid therebetween.
16. The device of claim 1 wherein the moveable stem body is optically clear.
17. The device of claim 16 wherein the fluid flow is optically opaque, the fluid blocking the signal reception in at least one position of the stem body, the stem body displacing the fluid flow in at least one other position of the stem body to allow the signal to be received.
18. The device of claim 1 wherein the stem body and the fluid conducting means are shaped, finished and contoured so that the static line pressure of the fluid is a constant at all points in the device and irrespective of the position of the stem body within the conducting means.
Claims Count: 18
Claims (English):

What is claimed is:
1. A fluid flow monitoring device comprising:
a transparent fluid conducting means enclosing a stem body movable along the fluid conducting means and biased against a proximal interior shoulder of the fluid conducting means, said shoulder defining a fluid inlet; and
a signal emitter-sensor means positioned externally to the fluid conducting means for transmitting a signal across the fluid conducting means from an emitter of the emitter-sensor means, to a sensor of the emitter-sensor means, such that with the stem body in a first stem body position within the fluid conducting means, the signal is blocked, and with the stem body in a second stem body position within the fluid conducting means, the signal is not blocked, said second stem body position adapted by the stem body as a result of a fluid flow within the conducting means wherein the fluid flow is sensed by the emitter-sensor means as the stem body moves.
2. The device of claim 1 further including a masking means interposed between the emitter-sensor means and the stem body, the masking means adapted for focusing the signal.
3. The device of claim 1 wherein the fluid conducting means is of a conical shape oriented such that resistance to the fluid flow by the stem body when in the second position is less then when in the first position.
4. The device of claim 1 further including a processor circuit in communication with the signal emitter-sensor means, and comprising a processor means, a clock means, a data storage means, a visual display means, and an alerting means, all interconnected, so as to enable the circuit to identify a time data, and display a fluid flow state, type of medication scheduled, and time of next scheduled medication.
5. The device of claim 4 further including parameter measuring instrument signal receiving means.
6. The device of claim 4 further including a communication means interconnecting the processor circuit with a computer, the computer being programmed to record and display data.
7. The device of claim 6 wherein the communication means is at least one electrically conducting path.
8. The device of claim 6 wherein the communication means is a wireless device.
9. The device of claim 4 further including an alerting means for signaling a user when recorded data corresponds with preprogrammed data.
10. The device of claim 9 wherein the alerting means produces an audible noise.
11. The device of claim 9 wherein the alerting means produces a mechanical vibration.
12. The device of claim 1 wherein the stem body has a circular cross-section with one end thereof providing a generally flat surface, said surface not forming a tight seal when in contact with the proximal shoulder.
13. The device of claim 12 further including a wristwatch size case encompassing the processor circuit, said case positionable for viewing and further including a fluid inlet conducting means, and a fluid outlet conducting means.
14. The device of claim 1 wherein the signal emitter-sensor means comprises a linear sequence of independent sensors, movement of the stem body blocking at least one of said sensors, such that the position of the stem body is known at each position of the stem body within the conducting means.
15. The device of claim 1 wherein the stem body includes a generally circular outside surface, the surface providing a plurality of fluidic pathways for conducting the fluid between the stem body and the conical wall of the conducting means providing improved conductance of the fluid therebetween.
16. The device of claim 1 wherein the moveable stem body is optically clear.
17. The device of claim 16 wherein the fluid flow is optically opaque, the fluid blocking the signal reception in at least one position of the stem body, the stem body displacing the fluid flow in at least one other position of the stem body to allow the signal to be received.
18. The device of claim 1 wherein the stem body and the fluid conducting means are shaped, finished and contoured so that the static line pressure of the fluid is a constant at all points in the device and irrespective of the position of the stem body within the conducting means.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A fluid flow monitoring device comprising:
a transparent fluid conducting means enclosing a stem body movable along the fluid conducting means and biased against a proximal interior shoulder of the fluid conducting means, said shoulder defining a fluid inlet; and
a signal emitter-sensor means positioned externally to the fluid conducting means for transmitting a signal across the fluid conducting means from an emitter of the emitter-sensor means, to a sensor of the emitter-sensor means, such that with the stem body in a first stem body position within the fluid conducting means, the signal is blocked, and with the stem body in a second stem body position within the fluid conducting means, the signal is not blocked, said second stem body position adapted by the stem body as a result of a fluid flow within the conducting means wherein the fluid flow is sensed by the emitter-sensor means as the stem body moves.
Independent Claims:
1. A fluid flow monitoring device comprising:
a transparent fluid conducting means enclosing a stem body movable along the fluid conducting means and biased against a proximal interior shoulder of the fluid conducting means, said shoulder defining a fluid inlet; and
a signal emitter-sensor means positioned externally to the fluid conducting means for transmitting a signal across the fluid conducting means from an emitter of the emitter-sensor means, to a sensor of the emitter-sensor means, such that with the stem body in a first stem body position within the fluid conducting means, the signal is blocked, and with the stem body in a second stem body position within the fluid conducting means, the signal is not blocked, said second stem body position adapted by the stem body as a result of a fluid flow within the conducting means wherein the fluid flow is sensed by the emitter-sensor means as the stem body moves.
Description:

This application is a continuation in part of application Ser. No. 08/360,994, filed Dec. 20, 1994, now U.S. Pat. No. 5,445,622.

FIELD OF THE INVENTION

This invention relates to intravenous (IV) fluid delivery systems and in particular to a monitoring device for providing information on when and if the delivery of an IV fluid to a patient actually occurred.

BACKGROUND OF THE INVENTION

The rapid rise of health care costs has become an important issue in modern society. To help reduce the costs, professional care givers have begun to seek alternatives, one of which is home health care services. These services not only tend to reduce costs, but are also preferred by the patient wishing to remain in his familiar environment. Among the many types of services provided are: respiratory care, rehabilitation therapy, cardiac monitoring procedures, and infusion therapy.

Infusion therapy involves IV administration of drugs. Making this therapy safe and convenient for a home situation allows a great number of patients who would otherwise be hospitalized to remain at home and still receive medication. Currently, over 300,000 patients annually use a home infusion therapy delivery system. Typically, patients include the elderly with chronic diseases like cancer, patients with either Crohns disease, HIV or other immune system disorders, and patients suffering from chronic pain. Many of these patients require infusion treatment over a long duration such as months or even years.

One characteristic of home IV drug therapy, in contrast to hospital administered therapy, is that a nurse is not always present or readily available. To provide safe and effective treatment, home infusion therapy usually requires that the patient himself, or other non-professional caregiver, such as a relative, administer IV fluids. Special training is required because many home care patients on IV therapy require multiple drugs or multiple doses of the same drug each day. The average nursing visit to a home infusion therapy patient is typically about 90 minutes including commuting time. The typical patient gets between 1 and 4 nursing visits per week, but has to take IV medications daily. Since the cost of daily care by a nurse is not usually covered by most insurers, the cost of attention by a nurse is most economically applied in training the patent or other amateur caregiver and in monitoring the therapy program.

In the home care situation non-compliance, over-medication or under-compliance with the IV therapy protocol is a serious issue and quite prevalent. For instance, non-compliance (not taking a medication) or under-compliance (taking fewer or smaller dosages than prescribed) occurs in up to approximately one-third to one-half of elderly home therapy patients. Typical compliance related problems include forgetting to follow the specified procedure for administration of the IV medication, forgetting to turn on the various devices used to administer the IV medication and forgetting to turn off a medical device which then delivers too much medication (over-medication). Reasons for compliance related problems are varied and include poor communication, confusion or forgetfulness regarding the procedures and/or equipment, or even attempts to avoid the adverse side effects of IV medications and fluids. Misapplication of the home IV therapy protocol can have serious ramifications resulting in greatly increased home health care nursing expenses, re-hospitalization, and reduction in health status of the patient. Thus, there is a strong need for improved monitoring of patient compliance with the health care program. Benefits of such improved monitoring and compliance include, but are not limited to, improved health at a lower cost, while still remaining in the preferred home environment.

To properly monitor compliance with an IV therapy protocol, a device may be provided for monitoring the flow of IV medications and fluids. The IV fluids for a single patient are likely to come from several different sources or systems including IV pumps, IV fluid controllers, gravity drips, syringes, and other devices.

A typical gravity powered IV may be as simple as an IV bag hanging on a pole in which a nurse or care giver manually adjusts a valve to limit the flow rate, but not control it accurately, or it may use an electronic controller which optically counts the drops of fluid as they pass an optical sensor and then adjusts the flow rate accordingly. However, optical drop counting sensors only provides an indication that the fluid is flowing past the sensor when in a vertical orientation such as hanging from an IV pole. Thus the patient and IV delivery equipment must remain relatively stationary during the administration of the medication or fluid. Optical drop counters also function poorly at higher flow rates and higher line pressures, such as when a syringe is used, because the fluid moving past the drop counter tends to become a continuous stream rather than remaining discrete drops. Therefore, the optical drop counter technique cannot be adapted for use with all fluid sources.

An alternative to an optical drop counting sensor, or as a stand-alone measuring device, is a single point pressure transducer to measure the fluid pressure in the IV tubing at a selected point of measurement. This type of sensor is common in IV pumps and is used to indicate that the pump is generating a static pressure head and, correspondingly, causing fluid flow or backpressure in the event of an occlusion in the IV line. This type of sensor only determines line pressure at the selected point, and is only useful in monitoring the pressure caused by the IV pumping device and the related backpressure caused by moving fluids into the patient's body. However, this type of single-point pressure sensor is useful in many IV delivery systems to determine if fluid pressures are at correct levels, and to detect changes in fluid pressure which are indicative of an occluded or collapsed vein. Often, when a certain threshold pressure is detected in a device using this type of sensor, an alarm is sounded to warn of a flow problem. This type of device measures changes in the static line pressure of a fluid line, but is unable to determine if a patient is following proper IV drug administration procedures and cannot differentiate between changes in pressure due to fluid flow versus some other cause, such as an occlusion in which there is actually no fluid flow.

Increased backpressure in an IV fluid line causes problems, and, as described above, many IV fluid delivery systems use a sensor to determine when high backpressure develops, i.e., greater than a few inches of water, for instance when an infiltration of tissue occurs or the tubing becomes occluded. Upon the detection of a significant backpressure, the device sounds an alarm and may function to automatically discontinue the delivery of the IV medication and fluids. Therefore, it is important that any device used to monitor whether or not fluid is flowing does not cause a substantial increase in backpressure or a false occlusion alarm might be triggered.

Other alternatives use indirect methods to monitor the flow of IV fluids. For instance, the speed and number of rotations in a pump mechanism may be monitored to indirectly determine when fluid flow is occuring. This is useful for flows caused by an IV pump, but is of no value to patients who also receive gravity drips or fluids via syringe. Since nearly all infusion therapy patients must perform venous access device maintenance procedures, such as a heparin flush via syringe to maintain the patency of their IV lines, this pump rotation technique is not of value for monitoring all infusions.

The time usage for an IV delivery system may be recorded to prepare bills to patients. Typically, the information is printed or stored in an electronic memory device such as the electronic controls for the drop counter or IV pump. The information may be used to determine which of several patients are using the IV system being monitored, it may be used to coordinate several IV delivery systems with a centrally managed pump, or it may be used to facilitate billing and reimbursement. Unfortunately, none of these systems accommodate tracking of fluid delivered from a variety of sources such as to a patient who receives syringes, gravity drips, and IV pump infusions. The present invention provides an improved flow indicator switch, which overcomes the above-mentioned limitations of the prior art.

SUMMARY OF THE DISCLOSURE

The present invention is an IV system which provides certain monitoring advantages. An electronic data processing and storage device is used in conjunction with a unique flow indicator switch to record events in the IV infusion process. The processor may be connected in real time or may be used simply as a data recorder for later analysis. If used in real time the processing device is used to interpret signals related to IV flow, to provide instructions on how to properly sense whether fluid flow is occurring, and on when to inform the user to use the IV system or even to take other medications, vis-a-vis, oral or injection therapy, etc.

In the preferred embodiment of the present invention, an IV infusion system provides a switch body conducting means having a movable stem body indicator to monitor a flow of fluid through a fluid flow path. The flow indicator includes a switch having a movable stem body that is forced to move by direct viscous forces against it within the flow path, so that it moves in the direction of fluid flow. The movable stem body can sense a change in system flow including positive flow startup from stagnation in order to indicate that fluid flow has stopped or started. A signal emitter-sensor means preferably including an infrared emitter and detector sense the change of position of the movable switch member. A spring element provides a restoring force to return the movable switch member to a null position indicating "no flow" when fluid flow has ceased. The force exerted by the spring element is adjusted to sense flow rates as low as 3.0 milliliters per hour.

Further, the conducting means has a variable orifice positioned in a shaped fluid passageway in the form of an annulus. The orifice changes in cross-sectional size depending upon the position of the movable stem body. The cross-sectional area of the orifice is designed to enhance sensitivity to low fluid flows when the orifice has a smaller cross-sectional area, as well as to limit backpressure generated by higher fluid flow when the orifice has a larger cross-sectional area. In the preferred embodiment, the increase in backpressure is limited to about 4 inches of water with flow rates as high as 3600 milliliters per hour. In the preferred embodiment, the flow indicator switch functions equally well at line pressures from a fraction of an inch of water to over 60 pounds per square inch pressure because no occlusion of the flowpath occurs. Therefore, the flow indicator switch is not an occlusive device and does not react to changes in static pressure.

The processor is preferably operationally coupled to the flow indicator switch, to monitor the time and date of starts and stops of IV fluid flow in the system. One preferred embodiment of the present invention provides for the processor to be housed in a case about the size of a wrist watch so that it is highly portable for wearing on the person. This provides several key advantages and benefits to the infusion patient which would not otherwise become possible.

The processor and the flow indicator may be operationally coupled by fluid conduits, electrical conductors, wireless transmitters and receivers, or the like. The processor includes a memory storage device which retains information related to the programmed IV protocol and the actual time of start and stop events. The processor may of course be interconnected with a computer or other high speed data device for data archiving purposes and for further data analysis. In the preferred embodiment, the processor is serially coupled with a notebook PC that downloads prescribed IV protocols and uploads actual fluid flow start/stop events for comparison. The downloaded and uploaded data may include fluid flow events from any or all sources of fluid including, but not limited to, IV pumps, gravity drips, and syringes.

The flow indicator switch may operate in any attitude providing an advantage over prior apparatus. Moreover, the flow indicator switch housing is formed with a fluid flow path that is easily de-aired by a flow of fluid through the device housing. The flow indicator switch is a passive device, in which the movable switch member is actuated by the fluid flow through the tube. It can have a sensitivity to low fluid flows of less than or equal to 3.0 milliliters per hour and a backpressure limited to less than or equal to 4.0 inch of water line pressure at higher flow rates common to intravenous drug therapy, such as 3600 milliliters per hour. The flow indicator switch can work well with pulsed fluid flows without triggering a false alarm in the fluid delivery equipment.

Another advantage is that the small size and portability of the flow indicator switch precludes the necessity of having the patient attach and detach the device each time it is used. It may be attached to the patient's IV catheter for long periods of time. Also, since it is a passive device, it requires less electrical power and maintenance, thereby reducing health care costs. It may be connected to a catheter or IV tubes by standard connectors typically used on common IV equipment, or it may be an integral part of the IV catheter tube assembly.

Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of the several embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures, in such drawings:

FIG. 1 particularly showing a signal emitter-sensor means and fluid conducting means with a stem body in a first position against a proximal shoulder is a perspective view showing on overview of the present invention in a general orientation as applied to a patient in a wrist or arm mounted embodiment;

FIG. 2 is a schematic representation of a first prefered embodiment of the present invention of FIG. 1 shown as the simple flow indicator switch held within the case shown in FIG. 1, wherein some dimensions are shown exaggerated for better understanding of the principles involved, and particularly showing a flow conduit, inlet and outlet orifices, stem body, and light emitter and detector of the preferred embodiment;

FIG. 2A is a cross-section view of the flow indicator switch taken along lines 2A--2A of FIG. 2 and particularly showing the preferred relationship between a proximal shoulder, the fluid conductor and an end of the stem body, wherein some dimensions are shown exaggerated for better understanding of the principles;

FIG. 2B is a schematic representation similar to that of FIG. 2 showing an alternate position of the stem body of the invention;

FIG. 3 is a schematic representation of a second prefered embodiment of the present invention of FIG. 1 shown as a flow rate indicator held within the case shown in FIG. 1, wherein some dimensions are shown exaggerated for better understanding of the principles involved, and particularly showing a flow conduit, inlet and outlet orifices, stem body, and light emitter and detector of the preferred embodiment;

FIG. 3A is a cross-section view of the flow indicator switch taken along lines 3A--3A of FIG. 3 and particularly showing the preferred relationship between a proximal shoulder, the fluid conductor and an end of the stem body, wherein some dimensions are shown exaggerated for better understanding of the principles;

FIG. 3B is a schematic representation similar to that of FIG. 2 showing an alternate position of the stem body of the invention;

FIG. 4 is a general block diagram of an electronic circuit of the invention showing the preferred interconnections of various electrical elements of the invention; and

FIG. 5 is a view of the preferred layout of the face of a wrist watch sized event monitor housing of the invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a fluid flow device for monitoring the flow of a fluid such as is used in medical applications such as infusion therapy where an IV fluid is monitored for providing information on the delivery of the IV fluid to a patient. Other fluids, and other applications both within medicine and outside of the medical field may be suitable for advantageously applying the device. Preferably, the device has a wristwatch sized case 80 that attaches to a patient's arm or that may be taped to the patient's chest depending upon the site of the IV catheter. The case 80 provides a visual display means 85 that is easily viewed by the patient. As shown more clearly in FIG. 5, the display 85 preferably displays a variety of different pertinent information such as the current time and date; the time and date of the next IV infusion process including which drugs to use; and the time and date of the last IV infusion process performed.

The monitoring apparatus for the intravenous fluid delivery is a system comprised of two primary components, the first being a processor circuit 60 housed within the case-80, used to store and record electronic data pertaining to fluid flow. The second component is a signal emitter-sensor means 52, for detecting fluid stop and start events as well as potentially monitoring of fluid flow rate.

Referring now to FIGS. 2, 2A and 2B, an important component of the fluid flow monitoring device is shown as fluid conducting means 20. Preferably, the conducting means 20 is a conductor that has a clear conical wall 22 for advantageously visually ensuring that air is removed from the IV fluid path. In one preferred embodiment, the fluid conductor 20 extends between proximal and distal fluid conduits 30P and 30D. The case includes an inlet fluid conductor means 87P that connects the proximal conduit 30P to a source of intravenous fluid, preferably an IV bag 84, or a syringe (not shown) or an IV pumping device (not shown) well known to the field. An outlet fluid conductor means 87D connects the distal conduit 30D to an intravenous discharge device 88 that discharges the IV fluid to the patient's vein.

The conductor wall 22 has a conical shape having a slight wall divergence of approximately between 0.03 to 2.0 degrees, so that it is larger at its distal end. Preferably, a proximal and distal circular shoulders 33P and 33D are provided at the ends respectively of the conductor 20, the proximal shoulder 33P defining an inlet fluid orifice 35P, and the distal shoulder 33D defining an outlet orifice 35D.

In the preferred embodiment, an opaque stem body 40 for use with optically clear fluids, is a movable piston or plug element, and is provided within the the conductor 20. An alternate embodiment, to be discussed later, uses an optically clear stem body 40 for use with opaque fluids.

In the preferred embodiment the body 40 has a volume of 6. 8586×10 -3 cubic centimeters and a density of approximately 1.25 grams per cubic centimeter. As shown in FIG. 2, the stem body 40 preferably has a circular cross section and is slightly smaller in diameter than the conductor 20. When the stem body 40 is positioned at the proximal end of the conductor 20 abutting the proximal shoulder 33P, the stem body 40 does not engage any portion of the conical wall 22. The stem body 40 has a generally flat surface 42 at the end that contacts the proximal annular shoulder 33P, but does not form a tight seal with the shoulder. The stem body 40 may have a relatively smooth (FIG. 2A) or a ridged (FIG. 3A) outer surface 44 that provides a series of fluidic pathways 46 for conducting the fluid between the stem body 40 and the conical wall 22, thus providing improved conductance of the fluid. The surface 44 and fluid pathways 46 are shown in FIGS. 3 and 3A in an exaggerated manner. The preferred dimensional clearance between stem body 40 and the proximal shoulder 33P is about 0.0015 inches and this effective gap may often be accomplished by virtue of the natural texture or roughness of the surface of the materials without having to especially provide for grooved fluid pathways as shown in the aforementioned figures. The stem body is biased, preferably by means of a stem body biasing means 45 such as a spring, so that the surface 42 of the stem body 40 is urged in position against the proximal shoulder 33P, thus partially, but not fully, closing the fluid conductor 20 under static conditions. This partial closure allows at least some of the fluid to pass out of the conductor 20 in the direction away from the patient in the event that blood must be drawn from the patient or fluid must be removed from the line. It also allows for instantaneous equilibrium between pressure changes upstream or downstream of the stem body 40 in that upstream and downstream fluids are not mutually isolated. Occlusion of the flow path does not occur.

The spring constant of the biasing means 45 is preferably approximately 0.06 pounds per inch of deflection which means that the stem body 40 is displaced by a very slight flow of fluid into inlet 35 P and out of outlet orifice 35D. It should be noted, however, that other spring constants and stem body masses may be selected for similar performance.

In one preferred embodiment shown in FIG. 2, the signal emitter-sensor means 52 consists of a signal emitter 50 positioned outside of the conductor 20, lateral to the stem body 40, and a single signal detector 55 positioned directly across from the emitter 50, on the opposite side of the conductor 20. As shown in FIG. 2, the left-hand side edge of the detector 55 is aligned with the proximal shoulder 33P and the base of the stem body 40. A masking means is positioned between the emitter-sensor means 52 and the stem body 40. In one preferred embodiment, the masking means 52 consists of one mask 56A positioned between the signal emitter 50 and the stem body 40, and another mask 56B placed between the detector 55 and the opposing side of the stem body 40. Preferably, both masks 56A and 56B have tiny openings that are aligned in corresponding pairs in opposition across the fluid conductor. In the preferred embodiment, these openings are between 0.003 to 0.030 inches in diameter depending upon the power of the emitter 50 and the sensitivity of the detector 55 These openings in the masks 56A and 56B restrict signal travel from the emitter 50, to a narrow signal path 58 across the fluid conductor 20, thereby focusing the signal. As seen in FIG. 2, when the stem body 40 is in position against the proximal shoulder 33P, the signal path 58 between the emitter 50 and the detector 55 is fully blocked by the opaque stem body 40, the signal is prevented from fully reaching the signal detector 55. However, as seen in FIG. 3, when the stem body 40 moves away from the proximal shoulder 33P, the signal path 58 is provided. Thus, any change in position of the stem body 40 within fluid conductor 20 is easily determined by whether the signal path 58 is blocked or not.

Although FIGS. 2 and 2B show an embodiment with a single signal detector 55, the signal emitter-sensor 52 may also consist of a linear sequence of independent signal emitters 50 and sensors 55 as shown in FIG. 3. In this alternative manner, an IV line with a constant flow, such as those used for KVO or "Keep Vein Open" applications, may be monitored for a meaningful change in flow rate. In the preferred embodiment, the signal emitter-sensor means 52 preferably emits and senses light signals in infrared wavelengths, although it is by no means limited to such use.

As mentioned previously, in the preferred embodiment the stem body 40 is opaque in order to block the passage of the signal from the emitter 50 to the detector 55 when used with optically clear fluids. In certain instances however, a patient may receive IV fluids such as blood products or feeding solutions, that are not optically clear. The optical properties of these opaque solutions naturally attenuate light passing through them. This attenuation is proportional to the length of distance that the light must pass through the fluid. Therefore, an alternative embodiment of the stem body 40 uses a clear plastic which then limits the attenuation to that which occurs over a few thousandths of an inch. In this manner, the electronics may be modified to receive an optical signal for "no-flow" conditions and an opaque or blocked signal for "flow" conditions.

The processor circuit 60 of the intravenous system may use a digital microprocessor chip to provide a logic program for interfacing the device into a therapeutic program of IV infusion and other medications. The circuit 60 preferably provides a means for using electrical signals from the detector 55 to store IV fluid flow event information. Intermittently, it is possible that non-fluidic events, such as the motion of a patient, may cause spurious signals due to minor displacements of the stem body 40. Testing has shown that these spurious signals are of short duration, such as a fraction of a second. The case 80 houses the processor circuit 60 which also includes logic for determining minimum "Flow On" time periods and intervals to remove most spurious signals from the log of flow events stored in memory.

The processor circuit 60 preferably includes a processor means 62, clock means 90 and a data storage means 95 interconnected so as to enable the processor circuit 60 to gather and record information concerning the infusion such as the time of day at start, time of day at stop, and time of day at change in IV flow rate with each associated flow rate change. The processor circuit 60 also preferably includes a parameter measuring instrument signal receiving means 130, which, in one preferred embodiment, consists of an analog-to-digital circuit, an amplifier and a jack. A variety of different measuring instruments (not shown), such as a scale or a thermometer, may be quickly and easily interconnected with the instrument signal receiving means 130 so that parameters pertinent to the patient's (pulse, blood pressure, body temperature, weight, etc.) condition may be easily and effectively monitored. The data received by the signal receiving means 130 is stored in the data storage means 95.

All data stored in the data storage means 95 may either be visually accessed by the patient at the display means 85 of the processor circuit 60 contained within the case 80, or, alternately, the circuit 60 may also include a communication means 100 that enables communication between the circuit 60 and a computer system 110. The communication means 100 may be either a hardwire or a wireless device of the type well known in the art. From the computer system 110, recorded data may be quickly uploaded and viewed.

A variety of pertinent information, such as oral medication schedule, may also be programmed into the computer 110 as desired. The processor circuit 60 of the present invention preferably includes an alerting means 120 for reminding the patient when to take oral medications or begin an IV infusion, for alerting the patient when the recorded body temperature is too high, fluid flow rate is too low, etc. To accomplish this, the desired information, as for example the times of day at which infusions should begin, is programmed into the computer 110. When the time recorded by the clock means 90 corresponds with the preprogrammed infusion times, the alerting means 120 alerts the patient by producing an audible alarm, vibrating or any other such means. In the same manner, a range of preferred fluid flow rates may be preprogrammed into the computer 110, and when the recorded flow rate during a infusion does not fall within the specified range, the alerting means is actuated.

Thus, in use, the proximal conduit 30P is connected to an IV bag or other fluid source, and the distal conduit 30D connects to an intravenous discharge device interconnected with a vein. Both conduits 30P and 30D and the conductor 20 are filled with IV fluid and deaired prior to attaching to the patient, and the stem body 40 is nominally positioned against the proximal shoulder 33P indicating a no flow condition. The system remains static until flow from the IV bag or other fluid source is activated and the stagnation pressure due to fluid motion against the stem body 40 increases. The force on stem body 40 overcomes the restoring force of the biasing means 45, causing stem body 40 to move away from the proximal shoulder 33P. This allows fluid which flows from the conduit 30P and through the inlet orifice 35P to be immediately sensed. The force of the fluid flow moves stem body 40 to a position within the fluid conductor 20 where a state of dynamic equilibrium is achieved between the force of fluid against stem body 40 and the restoring force. As stem body 40 moves further toward the distal end of the fluid conductor 20, as is typical at higher flow rates, the annular flow path area between the stem body 40 and the conical conductor wall 22 becomes larger, thereby increasing flow conductance in the conductor 20. Therefore a nonlinear relationship is developed between stem body displacement and conductance such that backpressure is minimized very quickly.

In particular, when the stem body 40 is positioned against the proximal shoulder 33P, as shown in FIG. 2, it blocks the signal from arriving at the leftmost edge of sensor 55. This leftmost edge of sensor 55 is particularly of interest in establishing if fluid in the system is static, or is flowing. Further, the signal reaching the leftmost edge of sensor 55 does not have to saturate the photodector means in signal sensor 55. In the preferred embodiment, a signal of about 300 millivolts is generated when the sensor 55 is fully saturated when both tiny openings 56A and 56B are fully exposed. However, an almost minuscule change in position of stem body 40 will cause a smaller change in voltage from 0.0 millivolts (totally opaque) to 0.5 millivolts because the leftmost edge of sensor 55 is partially illuminated. This smaller change is voltage is used to determine that fluid motion has commenced or ceased. Thus the signal induced by the leftmost edge of sensor 55 is used in the preferred embodiment to determine the "flow ON/OFF" time periods. The detector 55 signals are used in the processor circuit 60, thereby to log start and stop of fluid flow.

While the invention has been described with reference to a preferred embodiment, it is to be clearly understood by those skilled in the art that the invention is not limited thereto. Rather, the scope of the invention is to be interpreted only in conjunction with the appended claims.
Assignee/Applicant: Remote Medical Corporation,Newport Beach,CA
Assignee/Applicant First: Remote Medical Corporation,Newport Beach,CA
Assignee - Standardized: REMOTE MEDICAL CORP
Assignee - Original: Remote Medical Corporation
Assignee - Original w/address: Remote Medical Corporation,Newport Beach,CA
Assignee Count: 1
Inventor: Brown, Eric W.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W.
Inventor - w/address: Brown Eric W.,Newport Beach,CA
Inventor Count: 1
Attorney/Agent: Gene Scott Patent Law & Venture Group
Attorney/Agent - w/Address: Gene Scott Patent Law & Venture Group
Correspondent:
Correspondent - w/Address:
Examiner: Mendez, Manuel
Publication Country Code: US
Publication Kind Code: B1
Publication Date: 2001-09-18
Publication Month: 09
Publication Year: 2001
Application Number: US1995507122A
Application Country: US
Application Date: 1995-07-26
Application Month: 07
Application Year: 1995
Application with US Provisional: US1995507122A | 1995-07-26
Priority Number: US1994360994A
Priority Country: US
Priority Date: 1994-12-20
Priority Date - Earliest: 1994-12-20
Priority Month: 12
Priority Year(s): 1994
Earliest Priority Year: 1994
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US199483609A
1994-12-20
US5445622A
1995-08-29
Continuation-in-part
Granted
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M0005168, G01P001300
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M0005168
A
A61
A61M
A61M0005
A61M0005168
G01P001300
G
G01
G01P
G01P0013
G01P001300
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current

A61M 5/16886
G01P 13/0086

Y10S 128/13


20130101
20130101

EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604246, 128DIG13, 604065
US Class (divided): 604/246, 128/DIG13, 604/065
US Class - Main: 604246
US Class - Original: 604246 | 604065 | 128DIG13
ECLA: A61M0005168M, G01P001300C2
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent:
Count of Cited Refs - Non-patent: 0
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US4827970A
1989-05-09
Sugisaki Yuzuru
KAWASUMI LAB INC
-
0 (Examiner)
Title: Device for controlling liquid dropping
US5267980A
1993-12-07
Dirr Jr. William J.
RANDOM CORP
-
0 (Examiner)
Title: Optical components for an I.V. flow detector
US4452273A
1984-06-05
Hanzawa Yoshiki
TERUMO CORP
-
0 (Examiner)
Title: Apparatus for controlling drop-wise flow of fluid material
US4261388A
1981-04-14
Shelton Christopher D.
FRENSHORE LTD
-
0 (Examiner)
Title: Drop rate controller
US4680977A
1987-07-21
Conero Ronald S.
IVAC CORP
-
0 (Examiner)
Title: Optical flow sensor
US4652262A
1987-03-24
Veracchi F. Baldo
CRITIKON GMBH
-
0 (Examiner)
Title: Gravity infusion regulating apparatus
US5445622A
1995-08-29
Brown Eric W.
BROWN; ERIC W
-
0 (Examiner)
Title: Flow switch device for medical applications
Count of Cited Refs - Patent: 7
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
EP2278913A1
2011-02-02
HOSPIRA INC
JP2007111539A
2007-05-10
UP MAN GMBH & CO MED SYSTEMS K
US20100274128A1
2010-10-28
MALLINCKRODT INC
US20110270159A1
2011-11-03
MEDTRONIC INC
US6491640B1
2002-12-10
PULSION MEDICAL SYS AG
US6523414B1
2003-02-25
ZEVEX INC
US6641562B1
2003-11-04
HPS MEDICAL INC
US6878132B2
2005-04-12
DISETRONIC LICENSING AG
US6907788B2
2005-06-21
ZEVEX INC
US6980852B2
2005-12-27
SUBQIVIEW INC
US6999731B2
2006-02-14
INTEL CORP
US7121143B2
2006-10-17
ZEVEX INC
US7169107B2
2007-01-30
JERSEY-WILLUHN KAREN
US7184820B2
2007-02-27
SUBQIVIEW INC
US7326187B2
2008-02-05
JMS CO LTD
US7327273B2
2008-02-05
HUNG ORLANDO R
US7875009B2
2011-01-25
JMS CO LTD
US7887520B2
2011-02-15
SIMON MICHAEL G
US7914483B2
2011-03-29
BAXTER INT
US7921718B2
2011-04-12
ZEVEX INC
US8215157B2
2012-07-10
WANG JONG H
US8308698B2
2012-11-13
WAGNER GARY S
US8361010B2
2013-01-29
BAXTER INT
US8366667B2
2013-02-05
BAXTER INT
US8449500B2
2013-05-28
DELCASTILLO JORGE
US8480634B2
2013-07-09
SIMON MICHAEL G
US8523797B2
2013-09-03
LOWERY MICHAEL G
US8556869B2
2013-10-15
SIMON MICHAEL G
US8801656B2
2014-08-12
LOWERY MICHAEL G
USD633201S1
2011-02-22
ACE MEDICAL CO LTD
WO2005118030A2
2005-12-15
BAXTER INT
WO2013112832A1
2013-08-01
UNIV PITTSBURGH
Count of Citing Patents: 32
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2005-11-15
FP
-
Description: EXPIRED DUE TO FAILURE TO PAY MAINTENANCE FEE 2005-09-18
2005-09-19
LAPS
-
Description: LAPSE FOR FAILURE TO PAY MAINTENANCE FEES
2005-04-06
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
2000-05-30
AS
-
Description: ASSIGNMENT REMOTE MEDICAL CORPORATION, CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNOR:BROWN, ERIC W.; REEL/FRAME:010884/0111 2000-05-25
Post-Issuance (US): EXPI Expiration 2005-09-18 2005 2005-11-15 2005 DUE TO FAILURE TO PAY MAINTENANCE FEES
Maintenance Status (US): E1
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
REMOTE MEDICAL CORPORATION,NEWPORT BEACH,CA,US
BROWN, ERIC W.
2000-05-25
010884/0111
2000-05-30
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: GENE SCOTT PATENT LAW & VENTURE GROUP 3151 AIRWAY AVE., SUITE K-105 COSTA MESA, CA 92626
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
REMOTE MEDICAL CORPORATION,NEWPORT BEACH,CA,US
BROWN, ERIC W.
2000-05-25
010884/0111
2000-05-30
Reassignment (US) - Conveyance - Latest: ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: GENE SCOTT PATENT LAW & VENTURE GROUP 3151 AIRWAY AVE., SUITE K-105 COSTA MESA, CA 92626
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
License (EP) - License date:
EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US6290681B1
20010918
Brown Eric W.
REMOTE MEDICAL CORP
Title: Flow monitoring device for medical application
US5445622A
19950829
Brown Eric W.
BROWN; ERIC W
Title: Flow switch device for medical applications
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US6290681B1&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US6290681B1&format=gif&fponly=1
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Record 2/43
US5488368AA/D converter system and method with temperature compensation
Publication Number: US5488368A  
Title: A/D converter system and method with temperature compensation
Title (Original): A/D converter system and method with temperature compensation
Title (English): A/D converter system and method with temperature compensation
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: A=D converter with temp. compensation adjusts uncompensated digital signal to compensate for temp. variances, and uses voltage reference source whose signal is attenuated by passive circuit
Abstract:


An A/D circuit to convert an analog signal to a digital signal. The circuit includes a low noise analog-to-digital conversion chip and a precision voltage reference source. The voltage reference source includes a diode with two terminals and a passive attenuation circuit. The attenuation circuit and the diode are coupled in parallel between the two terminals to provide a voltage reference signal for use by the analog to digital conversion chip. The analog to digital chip uses the voltage reference signal to set the full scale input range for the signal conversion, and the voltage reference signal is attenuated to correspond to the full scale range of the analog signal. The A/D converter circuit has a passive temperature compensation feature to substantially eliminate or reduce the effects of thermal drift and of operating at different temperatures. Also, the A/D converter circuit can be coupled to a plurality of transducer inputs, such that the A/D converter circuit can measure voltage, current and resistance input signals.
Abstract (English):

An A/D circuit to convert an analog signal to a digital signal. The circuit includes a low noise analog-to-digital conversion chip and a precision voltage reference source. The voltage reference source includes a diode with two terminals and a passive attenuation circuit. The attenuation circuit and the diode are coupled in parallel between the two terminals to provide a voltage reference signal for use by the analog to digital conversion chip. The analog to digital chip uses the voltage reference signal to set the full scale input range for the signal conversion, and the voltage reference signal is attenuated to correspond to the full scale range of the analog signal. The A/D converter circuit has a passive temperature compensation feature to substantially eliminate or reduce the effects of thermal drift and of operating at different temperatures. Also, the A/D converter circuit can be coupled to a plurality of transducer inputs, such that the A/D converter circuit can measure voltage, current and resistance input signals.
Abstract (French):
Abstract (German):
Abstract (Original):

An A/D circuit to convert an analog signal to a digital signal. The circuit includes a low noise analog-to-digital conversion chip and a precision voltage reference source. The voltage reference source includes a diode with two terminals and a passive attenuation circuit. The attenuation circuit and the diode are coupled in parallel between the two terminals to provide a voltage reference signal for use by the analog to digital conversion chip. The analog to digital chip uses the voltage reference signal to set the full scale input range for the signal conversion, and the voltage reference signal is attenuated to correspond to the full scale range of the analog signal. The A/D converter circuit has a passive temperature compensation feature to substantially eliminate or reduce the effects of thermal drift and of operating at different temperatures. Also, the A/D converter circuit can be coupled to a plurality of transducer inputs, such that the A/D converter circuit can measure voltage, current and resistance input signals.
Abstract (Spanish):
Claims:

What is claimed is:
1. An A/D convertor circuit having low noise for converting an analog signal having a full scale input range into a digital signal, the circuit comprising: *
an analog-to-digital conversion circuit that produces an uncompensated digital signal; *
temperature compensation means for adjusting the uncompensated digital signal from the analog-to-digital conversion circuit to produce the digital signal; and *
wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the A/D circuit; and *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the analog-to-digital circuit further includes a voltage reference input, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to approximate the full scale input range of the analog signal.
2. A circuit according to claim 1, wherein the A/D convertor circuit further includes an auto-zero circuit to further reduce affects of a system drift.
3. A circuit according to claim 1, wherein the analog signal is a DC signal, and wherein the A/D convertor circuit further includes circuitry that is adapted to receive and convert DC signals.
4. A circuit according to claim 1, wherein the A/D convertor circuit further includes a driver circuit to drive at least one analog transducer.
5. A circuit according to claim 1, wherein the A/D convertor circuit further includes a transducer convertor for converting a resistance into a voltage to be converted by the A/D convertor circuit.
6. A circuit according to claim 1, wherein the A/D convertor circuit further includes a transducer convertor for converting a current into a voltage for conversion by the A/D convertor circuit.
7. A circuit according to claim 1, wherein the A/D convertor circuit further includes transducer convertors for converting both a current or a resistance into a voltage for conversion by the A/D convertor circuit, and selection means for selecting current, resistance or voltage sampling functions.
8. A data acquisition apparatus for converting an analog signal into a digital signal, the apparatus comprising: *
an analog-to-digital circuit having a voltage reference input; *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to correspond to the full scale input range of the analog signal; *
at least one transducer input coupled to the analog to digital circuit for receiving a corresponding at least one transducer signal; and *
temperature compensation means for adjusting the uncompensated digital signals from the analog-to-digital conversion circuit to produce the digital signal, wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the data acquisition apparatus.
9. An apparatus according to claim 8, wherein the apparatus further includes an auto-zero circuit to further reduce affects of a system drift.
10. An apparatus according to claim 8, wherein the analog signal is a DC signal, wherein the apparatus further includes circuitry that is adapted to receive and convert DC signals.
11. An apparatus according to claim 8, wherein the at least one transducer input is selected from the group consisting of a voltage input, a current input and a resistance input.
12. An apparatus according to claim 11, wherein the at least one transducer input includes a transducer convertor for converting a resistance into a voltage to be converted by the analog-to-digital conversion circuit.
13. An apparatus according to claim 11, wherein the at least one transducer input includes a transducer convertor for converting a current into a voltage for conversion by the analog-to-digital conversion circuit.
14. An apparatus according to claim 8, wherein the at least one transducer input is a plurality of different transducer inputs, each different transducer input for receiving a corresponding different transducer signal, each different transducer input includes a transducer convertor for converting a voltage, current or a resistance into a voltage for conversion by the A/D convertor circuit, and selection means for selecting current, resistance or voltage sampling functions.
Claims Count: 14
Claims (English):

What is claimed is:
1. An A/D convertor circuit having low noise for converting an analog signal having a full scale input range into a digital signal, the circuit comprising: *
an analog-to-digital conversion circuit that produces an uncompensated digital signal; *
temperature compensation means for adjusting the uncompensated digital signal from the analog-to-digital conversion circuit to produce the digital signal; and *
wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the A/D circuit; and *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the analog-to-digital circuit further includes a voltage reference input, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to approximate the full scale input range of the analog signal.
2. A circuit according to claim 1, wherein the A/D convertor circuit further includes an auto-zero circuit to further reduce affects of a system drift.
3. A circuit according to claim 1, wherein the analog signal is a DC signal, and wherein the A/D convertor circuit further includes circuitry that is adapted to receive and convert DC signals.
4. A circuit according to claim 1, wherein the A/D convertor circuit further includes a driver circuit to drive at least one analog transducer.
5. A circuit according to claim 1, wherein the A/D convertor circuit further includes a transducer convertor for converting a resistance into a voltage to be converted by the A/D convertor circuit.
6. A circuit according to claim 1, wherein the A/D convertor circuit further includes a transducer convertor for converting a current into a voltage for conversion by the A/D convertor circuit.
7. A circuit according to claim 1, wherein the A/D convertor circuit further includes transducer convertors for converting both a current or a resistance into a voltage for conversion by the A/D convertor circuit, and selection means for selecting current, resistance or voltage sampling functions.
8. A data acquisition apparatus for converting an analog signal into a digital signal, the apparatus comprising: *
an analog-to-digital circuit having a voltage reference input; *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to correspond to the full scale input range of the analog signal; *
at least one transducer input coupled to the analog to digital circuit for receiving a corresponding at least one transducer signal; and *
temperature compensation means for adjusting the uncompensated digital signals from the analog-to-digital conversion circuit to produce the digital signal, wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the data acquisition apparatus.
9. An apparatus according to claim 8, wherein the apparatus further includes an auto-zero circuit to further reduce affects of a system drift.
10. An apparatus according to claim 8, wherein the analog signal is a DC signal, wherein the apparatus further includes circuitry that is adapted to receive and convert DC signals.
11. An apparatus according to claim 8, wherein the at least one transducer input is selected from the group consisting of a voltage input, a current input and a resistance input.
12. An apparatus according to claim 11, wherein the at least one transducer input includes a transducer convertor for converting a resistance into a voltage to be converted by the analog-to-digital conversion circuit.
13. An apparatus according to claim 11, wherein the at least one transducer input includes a transducer convertor for converting a current into a voltage for conversion by the analog-to-digital conversion circuit.
14. An apparatus according to claim 8, wherein the at least one transducer input is a plurality of different transducer inputs, each different transducer input for receiving a corresponding different transducer signal, each different transducer input includes a transducer convertor for converting a voltage, current or a resistance into a voltage for conversion by the A/D convertor circuit, and selection means for selecting current, resistance or voltage sampling functions.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. An A/D convertor circuit having low noise for converting an analog signal having a full scale input range into a digital signal, the circuit comprising: *
an analog-to-digital conversion circuit that produces an uncompensated digital signal; *
temperature compensation means for adjusting the uncompensated digital signal from the analog-to-digital conversion circuit to produce the digital signal; and *
wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the A/D circuit; and *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the analog-to-digital circuit further includes a voltage reference input, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to approximate the full scale input range of the analog signal.
Independent Claims:
1. An A/D convertor circuit having low noise for converting an analog signal having a full scale input range into a digital signal, the circuit comprising: *
an analog-to-digital conversion circuit that produces an uncompensated digital signal; *
temperature compensation means for adjusting the uncompensated digital signal from the analog-to-digital conversion circuit to produce the digital signal; and *
wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the A/D circuit; and *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the analog-to-digital circuit further includes a voltage reference input, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to approximate the full scale input range of the analog signal.
8. A data acquisition apparatus for converting an analog signal into a digital signal, the apparatus comprising: *
an analog-to-digital circuit having a voltage reference input; *
a voltage reference source having a diode with two terminals and a passive attenuation circuit coupled in parallel between the two terminals to provide a voltage reference signal, wherein the voltage reference source is coupled to the voltage reference input of the analog-to-digital circuit, wherein the voltage reference signal is attenuated by the passive attenuation circuit to correspond to the full scale input range of the analog signal; *
at least one transducer input coupled to the analog to digital circuit for receiving a corresponding at least one transducer signal; and *
temperature compensation means for adjusting the uncompensated digital signals from the analog-to-digital conversion circuit to produce the digital signal, wherein the uncompensated digital signal is adjusted to compensate for variances due to the operating temperature of the data acquisition apparatus.
Description:

FIELD OF THE INVENTION

This invention relates to A/D converters and, in particular embodiments, an A/D converter system having an interface to a personal computer (PC) and an A/D converter circuit which uses a passively attenuated voltage reference. In preferred embodiments, the A/D converter circuits use a temperature compensation technique to passively reduce the effects of thermal drift and operating temperature, and in still further preferred embodiments the A/D converter circuits are combined with a plurality of transducer inputs to measure voltage, current and resistance input signals.

BACKGROUND OF THE INVENTION

Numerous types of analog-to-digital (A/D) conversion products are presently available. Many of these products are sold as bare circuit boards which allow incorporation of various different A/D chips and are used with a variety of data gathering platforms. Other products are sold as complete systems that can be connected to a personal computer (PC) and which then allow the user to collect data from a variety of sources. However, typical prior art products are deficient in their capability for low noise or substantially noise free operation, which inhibits their ability to adequately function in data acquisition systems for monitoring small DC voltage signals.

Some modern data acquisition systems interface directly with a PC. This allows for the efficient display and processing of the results, often in real time (or just a few milliseconds delay from true real time). The PC also provides a convenient way to store the large volumes of data, obtained from measurements, for later post-processing analysis.

Data acquisition systems typically combine input circuitry with an analog-to-digital converter (ADC) chip. Generally, the input circuitry of such systems receive input signals from a variety of transducers and the ADC produces digital outputs proportional to the varying level of the voltage of the input signals. ADCs typically have a full scale input voltage range of .+-.2.5 to .+-.5 V. To process a small DC voltage signal (i.e., a signal significantly less than the full scale input of the ADC), traditional systems typically employ one or more signal amplifiers to increase the small input voltage signal to correspondingly match the full scale voltage input range of the ADC chip. One drawback to this approach is that the amplification process introduces additional errors (i.e., noise) into the analog signal being amplified. Another common source of error and noise is the use of a multiplexer to sample several different analog inputs with a single ADC chip. This causes noise and spurious signal offsets due to the capacitive charge injection caused by switching between different wires containing the different analog inputs (e.g., often this noise plus offset is on the order of 10 mV peak to peak; see also FIG. 10) and can prevent the accurate measurement of small signals.

If the amplification is done correctly, then the full scale output of the amplified signal will match the full scale input in the A/D converter or at least use a significant portion of the ADC's full scale input voltage range. Therefore, amplification enables a user to view small signals with high resolution, since "extra bits" are added to the resolution. Thus, amplification of a .+-.0.5 V signal to a .+-.5.0 V signal which is converted in a .+-.5. 0 V full scale ADC provides a 10 time increase in resolution.

Although the small input signals are typically filtered prior to amplification in an attempt to reduce the amount of noise that will be amplified, these errors cannot be totally eliminated; and they are amplified along with the signal. Moreover, the amplification process itself adds noise to the signal and measurement uncertainty. Therefore, as the signal is amplified to increase the resolution during a conversion process, more noise or uncertainty is added to the signal. This tends to make it more difficult to accurately process small signals and adds uncertainty to the resulting digital output.

A typical "error-budget" for a small transducer signal (or measurement signal), which is amplified to match the full scale input range of an A/D converter chip ("Signal.sub.atA/D ") in a general PC-based A/D converter system, is a follows:

1. the transducer's signal or real measurement (Signal.sub. Device ");

2. the transducer's inherent, self-generated noise (Noise.sub. Device ");

3. environmental noise which radiates into the shielded and unshielded wire leads that connect the transducer to the amplifier ("Noise.sub. AmpLeads ");

4. environmental noise which radiates into the shielded and unshielded wire leads that connect the amplifier to the A/D input ("Noise. sub. A/DLeads ");

5. noise from the internal components that make up the amplifier ("Noise.sub.AmpInt ");

6. noise from the external components that make up the amplifier ("Noise.sub.AmpExt ");

7. span errors from temperature induced drift that affect the amplifier's internal gain stage ("Gain.sub.AmpInt ");

8. span errors from temperature induced drift that affect the amplifier's gain through the external components ("Gain.sub.AmpExt ");

9. input offsets in the amplifier which are multiplied by the gain ("Offset.sub.AmpInput ");

10. output offsets in the amplifier which are constants ("Offset. sub. AmpOutput "); and

11. spurious signal errors due to multiplexing several analog inputs which have differing line capacitances and other sources of errors ("Signal.sub.Spurious ").

This error budget yields the following equation for the signal received at the input to the A/D chip: ##EQU1## where the Gain.sub.Ideal equals the amplifier's desired gain multiplier. Depending upon the actual circuit being evaluated, the Signal.sub.Spurious term may or may not be multiplied by the cumulative gain of the three Gain terms.

This Signal.sub.atA/D leads to the following equation for the resulting output resolution for the signal:

Number of Bit-counts from the A/D as a Digital Output= .+-. Integer[(Signal.sub.atA/D /V.sub.ref) ×2.sup.n ]

Where n=the number of bits of resolution

The above-described error budget is not the only source of errors. Additional measurement errors in the output signal are caused by the A/D convertor's voltage reference circuitry. Generally, A/D circuits use a voltage reference ("V.sub.ref ") signal to set the full-scale input of the ADC chip. The ADCs use a variety of comparison techniques to arrive at the number of bit-counts a signal value represents when compared to the full scale represented by the value of V.sub.ref. The V. sub.ref is assumed to represent the maximum number of bits in the ADC. For example, if the voltage reference is 100 and the Signal.sub.atA/D is 95; then the bit count in an 18 bit ADC is 249,036; on the other hand, if the Voltage reference is actually 101, then the bit count should be 246, 571---an error of 2,465. Therefore, small errors in the V.sub. ref result in errors in the digital output signal.

The affects of all these errors on the conversion of a small signal from analog to digital can be demonstrated through some simple tests. One such test measures the noise present in an A/D circuit when there is a zero voltage level input applied to the ADC. This is called a "zero voltage level noise test. " To perform the test for an actual real world application, the leads connecting the sensor to the PC based A/D circuit are disconnected and the positive and negative leads are tied together so that there is no voltage differential between them. Specifically, the leads are tied together as close to the sensor and as far from the PC as possible. This is because most sensors are located a distance from the PC in real world applications to prevent noise from the PC containing the A/D circuit from radiating into the sensor setup. Often the lead length distances are on the order of 6 to 20 feet or more. Typically, shielded cable is used with the shield tied to analog ground. Theoretically the results of this test should yield zero volts because any noise which radiates into the shielded cable or any capacitive effects on the cables in this zero voltage level noise test would be canceled out via the differential inputs, since the positive and negative sides of the ADC input see the same input voltages induced by the noise.

Most manufacturers perform a different version of this test, and the results of this alternate version of the test are often far better than the results achievable in the real world test described above. In the alternate version of this test, the manufacturer shorts the input pins of the ADC chip together as close as possible to the ADC chip, not as close as possible to the sensor or area of actual usage. Usually, the lead length is only a few inches long or even less than one inch for this test. This short lead length is usually comprised of the metallic traces on the actual printed circuit board to which the ADC chip is mounted and terminates at the connector mounted on the same printed circuit board. In the event that a multiplexer is present to sample several analog inputs to a single ADC chip, the short lead length also substantially reduces the effects of the line capacitance. Since the input signal is essentially 0 volts, the charge injection problem is minimized and a very good sounding specification may placed on the equipment. Therefore, since no user can directly connect a device to the ADC circuit boards under the same conditions, and a circuit specification is determined for the system that has no bearing in the real world.

A typical real world input voltage test result is shown in FIG. 10. The results were generated by a conventional Analogic Corp. (Peabody, Mass.) High Speed DAS 16-bit analog-to-digital data collection board (Part No. HSDAS-16). The board is specified as having a resolution of 38 . mu.V (or 38×10.sup.-6 V) and is purported to have the capability to take accurate readings below 1 mV (or 1000×10.sup.-6 V). The board's specification also purports to have a maximum noise level of 76 . mu.V. However, in the test represented by FIG. 10, the product exhibited an inherent noise and offset of about 250-1000 μV RMS, and the peak-to-peak noise level often exceeded 10 mV. The larger peaks were the result of a multiplexer charge injection as different channels were scanned. During the test, the nominal on-board amplifier gain was set to 4.0 and approximately 6-8 feet of cable length was present between the area where the leads were tied together and the ADC chip on the printed circuit board. This long lead length was necessary because the PC radiates environmental noise that could be detected by the transducer to be used in this particular test setup. Also, this test setup involved the use of fluids and it was desirable to have the PC as far away as possible from the source of a potential spill or leak. The readings on eight differential inputs were scanned during this test.

In traditional ADC circuits, such as the HSDAS-16, the multiplexer is used to alternately measure several different analog voltage sources using a single ADC chip. The multiplexer also helps to protect the ADC chip from high voltages, such as a static discharge, that might damage the ADC chip.

Low pass filtering can help to smooth out the noise, but it does not have a significant affect on the offsets or uncertainty in the readings. The plot in FIG. 10 shows the results in only one channel, but each tested channel had a similar output curve with the only difference being the amount of the offset voltage errors.

Another test which can be performed is called a "fixed response transducer test". In this test, a pressure transducer is surrounded by a shielded, grounded metal case which is connected to the A/D data acquisition system. The pressure transducer is then given a thermally stable fixed head height of input pressure from a static column of water at room temperature. The thermal mass of the fluid is sufficient to prevent any measurable thermal drift in the sensor over a 1 to 10 minute test period. The fluid temperature during the test is monitored with a thermistor to within 0.1° C. The output of the transducer is then measured for noise. It is assumed that offsets and span errors cannot be measured with certainty, but they will still be within the transducer data. Tests performed on the Analogic system described above, yielded results which are quite similar to those shown in FIG. 10, but at a baseline voltage closer to the full scale analog signal from the pressure transducer (i.e., about 100 mV).

In many fields, computerized data acquisition has not been adequate, since low noise, high precision measurements that have a traceability to National standards, such as those set by the National Institute of Standards and Technology (NIST) and the like, are required. In typical prior art systems, to compensate for noise, the measurements are usually taken at lower sample rates to integrate or average out the environmental electronic noise, such that the required quality of measurement is provided. However, this does not remove all potential sources of error. For example, temperature has the ability to effect the accuracy of voltage, resistance and current readings at the μV, μ Ohm and μA levels. These effects are most prominent when the measurement requires an accuracy of a few microvolts. One solution to the temperature problem has been to provide a controlled environment, and actively heat the reference voltage source and critical components to maintain a fixed value above the ambient temperature (i.e., about 30. degree. C.). However, this requires additional circuitry which tends to increase the complexity of the system. Moreover, this technique fails when the ambient temperature rises above the heated, controlled environment or when the temperature drops too low for the heater to maintain the controlled environment. Furthermore, the accuracy of this technique can change with time, as the active heating elements drift to different temperature values.

SUMMARY OF THE DISCLOSURE

It is an object of an embodiment of the present invention to provide an improved analog to digital converter circuit, such as for use with small signals and the like, and which obviates for practical purposes, the above mentioned real world limitations. In particular embodiments the improved analog to digital convertor circuit uses a passively provided voltage reference signal to substantially eliminate noise in the conversion from an analog to a digital signal.

According to an embodiment of the invention, an A/D converter circuit is used to convert an analog signal into a substantially noise free digital signal. The circuit includes a low noise analog-to-digital conversion chip (ADC) and a passive voltage reference source. The voltage reference source includes a diode with two terminals and a passive attenuation circuit. The attenuation circuit and the diode are coupled in parallel between the two diode terminals to provide a voltage reference signal for use by the ADC. The ADC uses the voltage reference signal to set the full scale input range used in the conversion operation. In preferred embodiments, the voltage reference signal is attenuated to closely match or correspond to the full scale input range of the analog signal. Moreover, the circuit is particularly well suited to measure small DC voltage signals.

In further embodiments of the present invention, the passive attenuation circuit defines a resistor in a resistor and capacitor network. The resistor and capacitor network may provide a single pole low pass filter to attenuate high frequency noise in the reference voltage measurement. Moreover, the ADC may be capable of performing an auto-zero to reduce effects of a system drift.

In still further embodiments, the A/D converter circuit may include a multiplexer chip coupled with filter networks to selectively filter the analog signal prior to sending the filtered signal to the ADC for conversion from an analog to digital signal. Moreover, the A/D convertor circuit may include current output circuitry (i.e, drivers) and connections which can be used to drive analog transducers. In preferred embodiments, an A/D convertor circuit has a power source that is remotely located relative to the ADC to reduce the noise interference from the power source.

In further preferred embodiments of the present invention, the A/D converter circuit utilizes a passive temperature compensation feature to substantially eliminate or reduce the effects of thermal drift and of operating at different temperatures. In particular embodiments, the A/D converter circuit is calibrated at various temperature levels to derive a table or a set of equations that are used to passively adjust the digital signal output from the A/D converter circuit. In further embodiments, the A/D converter circuit is coupled to a plurality of transducer inputs, such that the A/D converter circuit can sample voltage, current and resistance input signals.

In particular embodiments of the present invention, the A/D converter circuit is included in an A/D converting system. The A/D converting system converts an analog signal into a digital signal while minimizing noise. The system includes an interface circuit and an A/D convertor circuit, as described above, coupled to the interface circuit. Preferably, the system provides means for selecting the level of attenuation of the voltage reference signal provided by the passive attenuation circuit. In traditionally designed A/D converting systems, the total system noise is typically less than about 10 mV peak-to-peak. However, in the preferred embodiments the total system noise is typically less than about 10 μV peak-to-peak or an improvement by a factor of about 1000.

In further system embodiments, the interface can accommodate a plurality of (e.g., eight) A/D converter circuits. Further the interface circuit may be cascaded together with at least one additional interface circuit. Moreover, in preferred embodiments the interface circuit may be cascaded with as many as thirty two other interface circuits, such that as many as, for example, 256 A/D converter circuits may be supported.

In other embodiments, there is no interface circuit and the A/D convertor circuits are directly connected to a personal computer in parallel with at least one other A/D convertor circuit. However, in preferred embodiments, the system uses a personal computer connected to the interface circuit, and wherein the personal computer is used to control and drive the A/D converting system through the interface circuit.

Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description of embodiments of the invention will be made with reference to the accompanying drawings, wherein like numerals designate corresponding parts in the several figures.

FIG. 1 is a block diagram of an A/D conversion system according to a first embodiment of the present invention.

FIG. 2 is a block diagram of an A/D conversion system according to a second embodiment of the present invention.

FIG. 3 is a block diagram of a variation of the second embodiments shown in FIGS. 2 and 3.

FIG. 4 is a block diagram of the interface unit used in the embodiment shown in FIG. 2.

FIGS. 5(a)-(d) illustrate a detailed circuit schematic of the interface unit shown in FIG. 4.

FIG. 6 is a block diagram of the A/D pods shown in the embodiments of FIGS. 1-3.

FIG. 7 is a circuit diagram of the voltage reference source illustrated in FIG. 6.

FIGS. 8(a)-(c) illustrate a detailed circuit schematic of the A/D pod shown in FIG. 6.

FIG. 9 is a plot of noise levels in an A/D convertor system according to an embodiment of the present invention.

FIG. 10 is a plot of noise levels in a prior art A/D convertor system.

FIG. 11 is a block diagram of a second embodiment of the A/D pod shown in FIG. 6.

FIG. 12 is a flow diagram illustrating a temperature calibration method used for calibrating an A/D pod as shown in FIG. 11.

FIG. 13 is a flow diagram illustrating a temperature compensation method for passively compensating for the temperature of an A/D pod as shown in FIG. 11.

FIG. 14 is a block diagram of a multiple input data acquisition device utilizing an A/D pod as shown in FIG. 6 or FIG. 11.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the present invention, relate to an A/D converter system used for measuring low level electrical signals in sensitive electronic apparatus, such as medical monitoring devices, seismic activity monitoring devices or the like. Commonly, these low level signals are generated by various forms of strain gauges or piezo-resistive transducers. However, further embodiments of the invention may be used to measure other types of signals which are converted from analog to digital signals. The A/D converter systems according to embodiments of the present invention are particularly well suited for sensitive measurements which present the user with a low signal to noise ratio.

Embodiments of the present invention are based in part on the principle that system noise may be minimized by reducing the number of noise inducing circuit components, especially active components, such as an amplifier or the like. Thus, embodiments of the present invention eliminate the amplifiers commonly used in A/D convertors to amplify the small input signal, and instead have an A/D circuit that will accept a low level signal directly. Moreover, since there are only a small number of ICs and discrete components in the low level signal path, thermally-induced junction voltage errors are minimized.

Further embodiments include such features as a software selectable filtering of the input signal, an on-board constant current source, jumper bridges to allow selectable full scale input ranges for the V.sub. ref, and overvoltage protection for the analog inputs. Moreover, the entire A/D converter and data acquisition circuit may be compact in size which allows it to be readily disposed in remote locations and to interface externally with a host processor (i.e., a PC) via serial or parallel data links. Thus, the A/D converter circuit may be positioned close to the transducer sensor, to minimize the length of the electrical connection (e.g., cable) between the A/D converter circuit and the transducer sensor, and therefore minimize the noise induced in the electrical connection.

Still further embodiments use a passive temperature compensation feature to substantially reduce or eliminate the effects of temperature drift or operating at different temperatures. In preferred embodiments, a table or a set of equations is used to determine the coefficients for altering the digital signal output from the A/D converting circuit. Moreover, other embodiments include a plurality of different transducer inputs that are coupled to the A/D converter circuit to sample voltage, current and resistance input signals. In preferred embodiments, the current and resistance input signals are converted to voltage signals that are digitized by the A/D converting circuit.

Preferably, the A/D converter hardware is designed to readily connect to a standard PC serial port (known as RS-232 by most computer users) for transmitting data to the PC which provides data acquisition control and analysis functions. Thus, no special adapter cards have to be installed in the PC. Moreover, the use of the standard serial port allows the PC to be located a great distance from the ADC circuit and the transducer whose analog signal is being measured.

In the illustrated embodiments, remotely located A/D data acquisition circuits (A/D pods) perform the conversion of an analog signal to a digital signal. In some embodiments, as many as eight A/D pods may be connected to a microprocessor controlled interface circuit which obtains the data from each A/D pod. The A/D pod may be used in a freestanding manner or it may be a subsystem within a PC-based data acquisition system. When the A/D pod is connected to a PC, the data can be readily viewed and recorded in real time (or near real time). Also, the data may be analyzed or manipulated in real time (or near real time) for use by other instruments or equipment.

Certain embodiments of the invention are particularly suitable as a "test and measurement" instrument for engineers and scientists working with low level DC electrical signals (i.e., under 0.5 V), such as from pressure sensors, strain gages, or chromatography equipment. The A/D pod may also be incorporated directly into medical devices designed for processing very small physiological signals. Embodiments of the A/D pod system may be particularly well suited for providing a low noise reading from a medical pressure sensor used in a hospital or home health care environment, both of which are typically electrically noisy environments. In this type of real world application, the A/D pod must measure unamplified differential DC voltages of approximately 300 μV (or about 300×10.sup.-6 V) to an accuracy better than 1% or about 3 . mu.V. Moreover, this type of differential signal is often superimposed on a DC signal that varies from about 1.0-200.0 mV. Therefore, the A/D pod should have a measurement resolution of 3 ppm (parts per million). To achieve high accuracy with reasonable levels of certainty, it is necessary to measure a raw signal with a less than 1.0 . mu.V resolution. Currently available PC based systems as described in the background section are inadequate for providing such measurements unless the analog signal is highly amplified, and then the signal is subject to the error factors discussed above.

FIG. 1 shows an A/D converter system 10 according to an embodiment of the present invention. This system includes a PC 12 coupled to two A/D pods 14 by data lines 16. In this embodiment, the PC is equipped with a parallel input/output (PIO) card, such as the Universal Digital I/O Interface (Model No. D-MAX54DIO48) sold by Personal Computing Tools, Inc. (Campbell, Calif.). The system 10 is capable of parallel processing the data from the two A/D pods 14 without an external auxiliary interface circuit. The A/D pods 14 interface directly with the PC 12 using line 16 connected to standard RJ-45 8 pin ports on the A/D pods 14 and the screw terminals on the PIO card within the PC 12. This parallel configuration allows the user to take as many as two measurements in real time for direct comparison of the results. In operation the A/D pods convert measurements from transducers (not shown) into digital signals which are then sent to the PC 12 for further processing and display. The received data can then be stored on the PC 12 for later access and/or post processing. In this embodiment, control command signals are supplied directly by the PC 12 to A/D pods 14 over lines 16. Power is provided by an external power supply. This embodiment may be currently limited to two parallel A/D pods 14 by the number of signal lines on the PIO card. However, PIO cards with more digital lines may accept more A/D pods 14.

A second embodiment of an A/D converter system is shown at reference numeral 20 in FIG. 2. The A/D convertor system 20 is composed of a PC 12, an interface unit 22 and a plurality (e.g., up to eight) A/D pods 14. The interface 22 is serially coupled to the PC 12 through line 24 using a RS-232 standard 9 pin port, and the A/D pods 14 are serially coupled to the interface 22 by lines 26 using a standard RJ-45 8 pin ports found on both the A/D pods 14 and the interface unit 22 circuit board. The interface unit 22 receives data from each of the A/D pods 14, and then forwards the received data to the PC 12 for processing over lines 24. As in the first embodiment, described above, the PC 12 can display and store the data for post processing.

The PC 12 is controlled by a host software program "TVIHOST" to communicate with the interface unit 22 and the A/D pods 14. A hard copy of a preferred embodiment of the TVIHOST program is attached as Appendix A as an example. However, further embodiments may employ other suitable programs. Preferably, the program controls the PC 12 to provide command signals to the interface unit 22 which then translates and passes command signals on to the appropriately selected A/D pods 14. The program also controls storage operations for storing of the collected data on suitable storage media, such as magnetic disks or the like, for later analysis of the data, as well as real time waveform and/or numeric displays. For instance, if a numeric display mode is selected, a 1-second mean and RMS noise levels are computed and displayed in real time. The TVIHOST program generally collects and stores the data in a binary format for quicker processing and later access. However, this format is not generally compatible with spreadsheets or other analysis software. Therefore, the TVIHOST program preferably includes a second program, EXP, which may be used to translate binary data into several different standard tabular formats which are easily imported into commercially available PC-based spreadsheet programs.

The interface unit 22 is the gateway between the PC 12 and the A/D pods 14. The interface unit 22 handles and translates all commands from the PC 12. Thus, a standard PC 12 only requires a standard, built in RS-232 serial port and the software to access the interface and the A/D pods; no additional hardware is required. All time critical interfaces to the A/D pods 14, such as when to send data and receive commands, are handled by the interface unit 22. Moreover, the interface unit 22 supplies the power to the A/D pods 14. The interface unit 22 also handles other functions, for example, commanding an automatic zero level compensation that reduces the noise from thermal drift. It should be understood that the A/D pods 14 are not limited to use with the interface unit 22 of the present embodiment, but may be used with any suitable PC or interface.

FIG. 3 illustrates a third embodiment, which is a variation of the embodiment shown in FIG. 2. This system 30 has a plurality of interface units 22 that are serially cascaded together by lines 32 using standard RS-232 9 pin ports. It is possible to cascade a first plurality X (e.g., as many as thirty two) of separate interface units 22; and since each interface unit 22 can support a second plurality Y (e.g., up to eight) of separate A/D pods 14, the cascaded system 30 may monitor as many as X * Y (e.g., up to 256) individual A/D pods 14 using one PC 12. The first interface unit 22 in the cascade is connected by an RS-232 line 24 in the same manner as shown in FIG. 2. Each additional interface unit 22 is connected to an adjoining interface unit 22 by an RS-232 line 32. The cascade system 30 uses the same TVIHOST program described above, to allow the PC 12 to communicate with the multiple interfaces 22 and all of the connected A/D pods 14. Therefore, the A/D converter system 30 may be readily expanded as measurement needs grow.

FIG. 4 shows a block diagram of the interface unit 22 used in the embodiments illustrated in FIGS. 2 and 3. The interface unit 22 has a power supply 40, an interface control 42, and an A/D control 44. The power supply 40 provides the +5.0 V power for both the interface unit 22 and all attached A/D pods 14. The ability to supply power to the interface control 42 and the A/D pods 14 from the power supply 40 provides several advantages, including the advantage of minimizing the number of individual power sources required, and the advantage of avoiding a major source of environmental noise (the power supply), since the power supply is external to the remote A/D pod 14. However, it should be recognized that further embodiments of the interface unit 22 may provide other power levels, and the A/D pods 14 may be powered by an internal source rather than externally powered.

The interface control 42 interfaces with the host PC 12 through a host port 46, and to other cascaded interface units 22 through a cascade port 48. Ports 46 and 48 are standard RS-232 9 pin serial ports. The interface control 42 includes a programmed processor circuit (e.g., controlled by a program recorded in a ROM device) which allows the interface unit 22 to prioritize itself among the other cascaded units 22 and to properly time the delivery of data to the PC 12. Moreover, the interface control 42 functions as a translator which receives command signals from the PC 12 and converts them into command signals for the A/D pods 14. Because these timing and translating functions are performed by the interface 22, the individual A/D pods 14 may be relatively simple in construction and small in size.

The interface control 42 is responsible for sending the data received from the A/D pods 14 to the PC 12. Typically, the data is sent to the PC 12 as a differential digital signal, since this reduces the amount of information that must be sent and allows higher communication rates. The differential digital signal only transfers the lowest number of bits which have changed since the last analog-to-digital conversion. However, it should be recognized that, according to further embodiments and as a user selectable option in the TVIHOST software, the entire digital signals provided by the A/D pods 14 may be sent to the PC 12.

The A/D pods 14 are controlled by the A/D control 44 through interface ports 50. The interface unit 22 has eight RJ-45 standard 8 pin connector ports 50, and the A/D pods may be connected into any one of the ports 50 or in any order. The interface unit 22, through the A/D control 44, prioritizes and handles all communications to the A/D pods 14. The A/D control 44 communicates with the A/D pods to control filter methods, system timing and other measurement parameters. The A/D control 44 receives data from the individual pods 14 and then sends the data to the interface control 42 which translates the data into a differential digital signal to be sent to the PC 12.

FIGS. 5(a)-5(d) show a detailed circuit schematic of a preferred embodiment of an interface unit 22. The illustrated interface unit 22 uses a Z-World Engineering Inc. (Davis, Calif.) single board computer, known as the model SmartBlock. This computer board uses a Z80 18.6 Mhz microprocessor to translate and process the command signals and data transfer between the A/D pods 14 and the PC 12. The ROM device containing the interface unit 22 instruction set is mounted on the single board computer.

FIG. 6 shows a block diagram of an A/D pod 14 which may be used in the embodiments shown in FIGS. 1-3. The A/D pod 14 includes an interface unit I/O (Input/Output) 60, an ADC (Analog-to-Digital Chip) 62, a V.sub.ref (Voltage reference) source 64, a multiplexer 66 with filters, and a transducer input 68.

The interface unit I/O 60 supports communication with the interface unit 22. The I/O 60 uses an RJ-45 8 pin port to receive command signals from the PC 12 through the interface unit 22. The received command signals are used to control the A/D pods timing and how the A/D pod 14 will filter and convert the analog signal received from the transducer input 68 to a digital signal. Moreover, the I/O 60 receives a power signal and provides power to the A/D pod 14. The I/O 60 is connected to the ADC 62 which is used to control the other blocks in the A/D pod 14.

The ADC 62 receives command signals from the I/O 60, and provides command signals to control the multiplexer 66. The command signals from the ADC 62 determine which filters connected to the multiplexer 66 are used in processing the analog signal before conversion to a digital signal. The full scale input range to the ADC 62 is set by the V.sub.ref provided by the V.sub.ref source 64. Once the full scale input range is set, the filtered output signal from the multiplexer 66 is compared with the V.sub.ref signal and the ADC 62 produces a digitized signal based upon this comparison. The digitized signal is then sent by the ADC 62 to the interface unit I/O 60 where it is sent back to the PC 12 for display and further processing. In the preferred embodiments, the ADC 62 continuously converts the analog signal into a digital signal, and the interface unit 22 only transmits the digital signal to the PC 12 when a new update is required by the PC 12. This method tends to lighten the communication load and further simplify the design of the A/D pod 14. However, in other embodiments, the ADC 62 need not convert the signal continuously, and the user may select nearly any conversion rate slower than 16 times per second.

The transducer input 68 to the A/D pod 14 is used to receive the analog signal from the transducer (not shown) and provides the signal to the multiplexer 66 for filtering. In some embodiments of the present invention, the A/D pod 14 may be provided with a constant current source which can be used to power and drive the transducer. This can simplify the construction and cost of systems which use transducers with the A/D pods 14. However, the transducer may be internally powered or powered by a source other than the A/D pod 14. Other embodiments of the A/D pod 14 may include a constant voltage source or other suitable driver which can be used to power and drive other transducers.

The multiplexer 66 receives the analog signal from the transducer input 68 and filters the information prior to sending the analog signal to the ADC 62. In preferred embodiments of the present invention, the multiplexer has four filtering options. However, the multiplexer may utilize any number of filters and more than one multiplexer may be used. In addition to filtering, the multiplexer provides protection to the input terminals of the ADC chip from high voltages such as a static discharge.

The full scale input range of the ADC 62 is determined by the V. sub. ref signal which is produced by the V.sub.ref source 64. In preferred embodiments of the present invention, the V.sub.ref source 64 is a precision source that does not use active elements, such as an amplifier or a power supply, to generate the V.sub.ref voltage reference signal. Rather, the V.sub.ref is generated by a diode and passively attenuated to form an input range that closely matches the full scale input range of the unamplified analog signal. This removes a substantial portion of the noise sources that are found in the prior art A/D convertor circuits which utilize amplifiers to create a gain stage for the analog signal. Thus, the use of a V.sub.ref that is passively attenuated can provide significant advantages over the prior art systems discussed in the background section, in that this feature can result in a substantial reduction of noise in the converted signal.

FIG. 7 shows a circuit schematic of an embodiment of the V.sub. ref source 64 used by the A/D pod 14. The V.sub.ref source 64 does not use an amplification circuit to determine the full scale input range used by the ADC 62 (see FIG. 6). Rather, it is attenuated to match the range of the small analog signal. To provide the V.sub.ref, the power from an external source, such as the interface unit 22, is attenuated through a first resistor 70. One end of the resistor 70 is coupled to the power source and the other is coupled to a diode 72 and a passive attenuation circuit 74. The passive attenuation circuit 74 is coupled in parallel to the ends of the diode 72. Typically, the passive attenuation network is formed of one or more resistors 76 and one or more capacitors 78 connected in parallel, as shown in FIG. 7. In preferred embodiments, a precision zener diode is used with a resistor chip and a capacitor. However, the circuit may use any suitable diode or resistor which provides the proper level of attenuation. The passive attenuation circuit may also include a capacitor to form a single pole, low pass filter to reduce high frequency noise (e. g., greater than 32 Hz). In preferred embodiments of the present invention, the V.sub.ref is attenuated to provide a full scale input range of .+-.200 mV to .+-.500 mV which provides a resolution of approximately 0.763 μV to 1.907 μ V per count of the A/D converter.

FIGS. 8(a)-8(c) show a detailed circuit schematic of a preferred embodiment of the A/D pod 14. With regard to the analog-to-digital converter chip, the MAX132 converter chip (shown as U1 in FIG. 8(a) and manufactured by Maxim Corporation of Sunnyvale, Calif.) was selected. A MAX132 circuit provided a full scale input of about .+-.200 mV to .+-. 500 mV with good noise and drift levels. The ADC also incorporates features which eliminate 60 Hz noise sources from the acquired signal through an averaging technique. The A/D converting circuit also uses a multiplexer chip MAX359 (shown as U2 in FIG. 8(c)) to provide four analog signal filtering options of no signal filtering, 0.08 Hz, 0.8 Hz and 8 Hz. The filters are selected by pins P0 and P1 on the ADC. Finally the V.sub. ref source is shown in FIG. 8(b) using a zener diode (shown as D1) and a resistor chip (shown as R3) to provide the attenuated voltage reference. It should be understood that other diodes, and resistor and capacitor combinations may be used. By changing these components V.sub. ref signals of up to 1.2 V and 2.5 V are readily achievable. For instance, other jumper pad connections on the resistor chip may be used to obtain different V.sub. ref signals. In further embodiments, the jumper pads may be user selectable to provide a selectable V.sub.ref signal attenuation; however, this would probably require an additional multiplexer to facilitate the selection of the appropriate jumper positions and possibly the selection of a different integrating capacitor and resistor, depending on the range selected.

There are several advantages obtainable with a passively attenuated V. sub.ref. There is a reduction in the number of components needed to generate the digital signal, since neither the analog signal nor the V. sub.ref must be amplified. Therefore, the noise that would otherwise be generated by these additional components is not present and the system would exhibit a reduced (compared to signal amplifying systems) sensitivity to temperature drift due to the minimization of components, and thus error sources. Moreover, since amplifiers are not needed to provide the V.sub.ref or amplify the analog signal, the noise sources created by the amplification process may be completely eliminated. The result is less noise at the inputs of the ADC chip.

The A/D pod 14 is also externally powered, which can significantly reduce the noise in the resulting digital signal. The external power source permits the A/D pod to be located outside the noise filled environment within the PC 12 which may otherwise interfere with the ADC and other components of the A/D pod 14. Moreover, external powering allows the A/D pod 14 to be packaged in a small configuration and be located close to the transducer where the actual measurements are taken. Close proximity to the transducer reduces the line length between the ADC and the transducer. Thus, the ability to locate the ADC in a minimum noise environment and in close proximity to the measurement source can minimize the noise input to the ADC 62.

Therefore, embodiments of the present invention using a passively attenuated V.sub.ref and external power source yield the following equation for the signal at the A/D:

Signal.sub.atA/D =Signal.sub.Device .+-.Noise.sub.Device .+-. < 0.1 Noise.sub.A/DLeads

It can be readily appreciated that the above-equation has far fewer noise terms than the equation for the A/D converters in the prior art structures described in the background section.

Typical noise levels obtained in the above-described embodiments of the present invention are in the range of 4 μV RMS. The same tests, described in the background of the invention above, were performed on various embodiments of the present invention. The results showed that the circuits reduced the noise and offset problems found in real world applications of the prior art devices by a factor of 100 to 1000 times. A sample of the results from a zero level test are shown in FIG. 11. The combined noise and offset errors were reduced to under 5 μV RMS and about 8 μV peak-to-peak over long sampling periods. However, during shorter test periods, the results were even better (about 2≧3 μ V RMS and about 3≧4 μV peak-to-peak).

Comparisons of the two noise plots in FIGS. 9 and 10 show that embodiments of the present invention exhibit significantly less noise than converter systems in the prior art. For example, if FIG. 9 were superimposed on FIG. 10 using the same vertical scale, the noise in the FIG. 9 plot would be a thinner line than can be printed on FIG. 10. This is because FIG. 10 shows noise in millivolts and FIG. 9 shows noise in microvolts (a difference of 1000 times).

FIG. 11 shows a second embodiment of the A/D pod 114, which is similar in some respects to the A/D pod 14 shown in FIG. 6. This A/D pod 114, like the A/D pod 14, includes an interface unit I/O (Input/Output) 60, ADC (Analog-to-Digital Chip) 62, V.sub.ref (Voltage reference) source 64, multiplexer and filters 66 and transducer input 68 as described above. However, the A/D pod 114 further includes a CPU with built-in RAM 116, a ROM 118 and a temperature sensor 120 to provide passive temperature compensation of the digital signal output from the ADC 62. Using the passive temperature compensation method described below, the A/D pod 114 is capable of making accurate measurements below 1.0 μV (1×10. sup.-6 Volts). The passive temperature compensation method, described below, can be used because the A/D pod 114's circuitry functions in a repeatable manner at any given temperature within the operating range of the A/D pod 114. This allows the digital signal output by the A/D pod 114 to be adjusted in real time, strictly on the basis of temperature, without active monitoring of the output from the A/D pod 114.

In the illustrated embodiment, the A/D pod 114 provides traceability to standards, such as NIST or the like, and is operable over a broad range of temperatures. In preferred embodiments, the operable temperature ranges from 0° C. to +95° C. However, in other embodiments, the temperature range may be larger or smaller. Thus, the A/D pod 114 is capable of producing the accuracy and precision of a .+-. 10 ppm (part per million) calibration standard over a wide range of operating temperatures. Moreover, the A/D pod 114 may use a temperature compensation feature as described below and shown in FIG. 13. Alternatively, it may function as the above-described A/D pod 14, if the CPU 116 is commanded to send the digital signal output from the ADC 62 to the interface unit I/O 60 without alteration.

In the A/D pod 114, the CPU 116 receives the digitized signal output from the ADC 62, and is controlled by software stored in the ROM 118 to calculate an adjustment coefficient. Based on the temperature measurement from the temperature sensor 120, the CPU 116 then uses the calculated coefficient to passively adjust (i.e., without monitoring the output of the ADC 62) the value of the digital signal from the ADC 62 in real time. The digital signal may be altered up or down, depending on the individual characteristics of each A/D pod 114. Once the digital signal has been adjusted to compensate for the effects of temperature, the CPU 116 directs the signal to the interface I/O 60, where it is processed as described above for the A/D pod 14 shown in FIG. 6.

The ROM 118 stores a set of equations to determine the adjustment coefficient based on temperature. The equations are determined from a calibration method (such as illustrated in FIG. 12 and described below). In preferred embodiments, the equations are in the form of a linear slope and intercept that are based on temperature. These equations permit the digital signal to be adjusted to compensate for temperature changes in increments of 0.1° C. However, in other embodiments, the equations may be curves, or may be a plurality of equations representing different portions of the operating temperature range of the A/D pod 114. Moreover, in still other embodiments, larger or smaller temperature increments may be used. In alternative embodiments, the ROM 118 may contain an interpolation table of data that is used, instead of a set of equations, to adjust the digital signal from the ADC 62. The ROM 118 also contains the software that is used to determine the adjustment coefficient. For example, the software includes instructions for: determining how often temperature measurements are taken, how the coefficient is calculated, how the digital signal from the ADC 62 is altered, and the like.

FIG. 12 shows a flow chart representing one embodiment of a calibration method used to calibrate the A/D pod 114 shown in FIG. 11. A hard copy of a preferred embodiment of the "TEMPCAL" program, which can perform the calibration method, is attached as Appendix B as an example. The calibration method is used to produce the table or equations that are stored in the ROM 118, and used by the CPU 116 to passively adjust the digital signal output from the ADC 62 to compensate for changes in temperature. In step 150, prior to performing the remaining calibration method steps, the A/D pod 114 is placed in a temperature controllable environment, such as a temperature chamber, oven or cooler, and attached to a data acquisition device, such as a processor, personal computer (PC) or the like. The A/D pod 114 is also attached to a power supply and an input device capable of providing known input reference signals that are calibrated to a standard, such as NIST or the like. In preferred embodiments, more than one A/D pod 114 is attached to the calibration and data acquisition devices at the same time, and in still other embodiments, one of the A/D pods 114 is used to accurately sample the surrounding environmental temperature and serve as a temperature reference for the other A/D pods 114 being calibrated.

In step 152, power is applied to the A/D pod 114 and the A/D pod 114 is allowed to reach a stable operating temperature. Next, in step 154, a calibrated input reference signal, such as a voltage signal, current signal, resistance signal or the like, of a known value is selected. The input signal is preferably provided by a device that has been calibrated against a known standard and is traceable to NIST or some other nationally recognized reference standard. The selected input reference signal is applied to the A/D pod 114, which converts the input signal into a digital output signal. In step 156, the digital signal output from the A/D pod 114 is measured and compared to the standard calibrated value of the reference input signal to determine the difference between the two signals (i.e., the known input signal and the output digital signal). In step 158, the raw data, which includes the value of the calibrated signal, the value of the digital output, the current temperature, and the difference between the theoretical value of the calibrated input signal and the actual digitized output signal, is stored in the data acquisition device or PC for later analysis.

In step 160, it is determined if all of the input reference signals have been applied to the A/D pod 114 and whether the differences have been measured. In preferred embodiments, 10-12 different calibrated input reference signals are applied and sampled at each temperature level. However, in alternative embodiments, more or less input reference signals per temperature level may be used. In step 160, if more input reference signals are to be sampled, the calibration method returns to step 154 and repeats the sampling until all input reference signals have been sampled. On the other hand, if all the reference signals have been sampled, the calibration method advances to step 162, it is determined whether or not all the temperature values have been sampled.

If it is determined that more temperature values are to be sampled, the calibration method advances to step 164 and the temperature is altered to the next level to be sampled. At this point, the temperature controlled environment and the A/D pod 114 are given sufficient time to stabilize at the new temperature level. In preferred embodiments, the temperature is incremented in steps of 1° C. However, in alternative embodiments, the temperature may be incremented by larger values, such 5°-10° C. or the like, or by smaller values, such as 0.1°-0.5° C. or the like. Once the temperature has stabilized, the calibration method returns to step 154 and repeats the steps of sampling and comparing the output of the A/D pod 114 at the new temperature level.

If the A/D pod 114 has been calibrated at all of the temperature levels and with all of the input reference signals, the calibration method advances to step 166. In step 166, the raw data, stored during the calibration method, is retrieved from storage and a mathematical multiple regression is applied to the raw data to yield, for example, equations and/or interpolation data. This equation and/or interpolation data will be stored in the ROM 118 and used by the CPU 116 to passively alter the digital signal output from the ADC 62 based on the temperature level at which a measurement is being performed. If the raw data yields a relatively linear relationship, then equations can be effectively used by the CPU 116 of the A/D pod 114. However, if the raw data is non-linear or discontinuous, an interpolation look up table may be more effectively used by the CPU 116 of the A/D pod 114. Once the raw data is analyzed, the calibration method advances to step 168, for a determination as to whether or not satisfactory equations were obtained. If satisfactory equations were obtained (i.e., linear), the calibration method advances to step 170 and stores the equations in the ROM 118, or on a PC for later input into the ROM 118. On the other hand, if the obtained equations are not satisfactory, an interpolation table is stored in the ROM 118, or on a PC for later input into the ROM 118. In alternative embodiments, both the equations and the interpolation table are stored into the ROM 118 for selective use by CPU 116 of the A/D pod 114. After storage of the analyzed data the calibration method advances and terminates at step 174.

FIG. 13 shows a flow chart representing one embodiment of a temperature compensation method used to adjust the digital signal output from the A/D pod 114 of FIG. 11. This compensation method is used to compensate for changes and variations of temperature during the operation of the A/D pod 114. In step 180, prior to performing the remaining compensation method steps, the A/D pod 114 is connected to a data acquisition system that receives the digital signal output from the A/D pod 114, and a measurement transducer that provides the input to the A/D pod 114. Also in step 180, the temperature compensation method is enabled by a command, for example, sent from the data acquisition system to the CPU 116 of the A/D pod 114. Once the power is switched on in step 180, the compensation method advances to step 182.

In step 182, the temperature sensor 120 determines the temperature of the A/D pod 114, and this value is stored for later use by the CPU 116. In preferred embodiments, the temperature is measured by the temperature sensor to an accuracy of 0.1° C.; however, other accuracy levels can be used. In step 184, the input signal from the measurement transducer is sampled and converted by the ADC 62 of the A/D pod 114 into a digital signal. In step 186, the digital signal from the ADC 62 is sent to the CPU 116, which uses the last measured temperature from the temperature sensor 120 and the equations (or table) from the ROM 118 to determine an adjustment coefficient. Next, the CPU 116 uses the adjustment coefficient to alter the digital signal received from the ADC 62 to compensate for variances caused by the temperature. After the digital signal has been adjusted for compensation, the adjusted digital signal is sent by the CPU 116 to the interface unit I/O 60, which in step 188 sends the adjusted digital signal to the data acquisition system in the manner described above for the A/D pod 14 shown in FIG. 6.

After the adjusted digital signal has been sent to the interface unit I/O 60, the compensation method advances to step 190, where a decision is made as to whether or not the temperature should be remeasured and updated. In preferred embodiments, the temperature is remeasured every 1-10 seconds. However, in alternative embodiments, the temperature can be measured more or less often. In step 190, if it is time to remeasure the temperature, the compensation method returns to step 182 and the temperature is remeasured and updated. On the other hand, if the temperature is not to be updated, the compensation method advances to step 192, which determines if further samples from the measurement transducer are to be taken. In step 192, if further samples are to be taken, the compensation method returns to step 184. On the other hand, if no further samples are to be taken, the compensation method advances to step 194 and further samples are suspended.

FIGS. 12 and 13 illustrate one preferred embodiment of a temperature calibration and a temperature compensation method. However, other methods may be used. For example, in the calibration method, the A/D pod may be subjected to a plurality of different types of reference input signals (i. e., voltage inputs, current inputs, resistance inputs or the like). Moreover, in the compensation method, the digital signal from the ADC 62 might be received by the data acquisition system unaltered, and the data acquisition system, itself, calculates the adjustment coefficient and adjust the signal independently of the A/D pod 114. Also, the compensation method may be combined with other compensation techniques, such as with an auto-zero capability that reduces errors due to system drift that tends to occur from long periods of continuous operation. Furthermore, the temperature calibration and temperature compensation methods may be used to improve the accuracy of typical prior art A/D converting circuits.

FIG. 14 shows an embodiment of a data acquisition apparatus 200 that is capable of sampling and converting voltage signals, as described above, but also is capable of sampling and converting current and resistance signals. The core of the data acquisition device 200 is an A/D pod 214, which may be either an A/D pod 14 or 114 as described above, that is connected to a plurality of different transducer type inputs. These transducer inputs are a voltage transducer input 216, a current transducer input 218, and a resistance transducer input 220, each being adapted to receive signals from a respective type of transducer. Since the above-described embodiments of the A/D pod are already capable of sampling voltages directly, to sample voltage inputs, the voltage transducer input 216 is directly coupled to the A/D pod 214. To sample current inputs, the current transducer input 218 is coupled to the A/D pod 214 through a current to voltage convertor 222 that converts the current into a voltage that is supplied to the A/D pod 214. To sample resistance inputs, the resistance transducer input 220 is coupled to the A/D pod 214 through a resistance to voltage convertor 224 that converts the resistance into a voltage that is supplied to the A/D pod 214. In particular embodiments, the data acquisition device 200 can sample voltage signals between .+-.200 mV to .+-.700 mV, current signals between 20 to 200 mAmps DC and resistance signals between 100 to 100,00 ohms. However, in preferred embodiments, the data acquisition device can sample voltage signals between .+-.100 mV to .+-.2.0 V, current signals between 10 mA to 1 A Dc, and resistance signals between 1.0 to 1,000,000 ohms. However, in other embodiments, the data acquisition device 200 may sample larger ranges.

In alternate embodiments, the A/D Pod 214 may include only one of the current transducer inputs 218 or resistance transducer inputs 220 such that single function A/D Pods are built. Also, the selectable A/D Pods which include voltage, resistance and current measuring capability may be software selectable by the user or selectable by other means, such as a switch or the like.

The A/D pod 114 (illustrated in FIG. 11) is shown with an on-board CPU 116 and ROM 118 for performing the temperature compensation method. However, in alternative embodiments, the compensation method is performed by an external processor, PC or the like, and the equations or interpolation table stored in the ROM 118 is actually stored in memory associated with the processor, PC or the like. Moreover, in other embodiments, the A/D pod 114 has a ROM 118 which downloads the equations or the interpolation table to a host PC for compensation in the PC after receipt of the uncompensated signal. Furthermore, the CPU 116 may be any suitable processor, such as a microprocessor or the like, the ROM 118 may be any suitable storage device, such as an EPROM, static RAM, or the like, and the temperature sensor 120 may be any suitable temperature measuring device, such as a thermocouple, thermal resistor or the like.

While the description above refers to particular embodiments of the present invention, it will be understood that many modifications may be made without departing from the spirit thereof. The accompanying claims are intended to cover such modifications as would fall within the true scope and spirit of the present invention.

The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims, rather than the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Assignee/Applicant: TechnoView Inc.,Newport Beach,CA,US
Assignee/Applicant First: TechnoView Inc.,Newport Beach,CA,US
Assignee - Standardized: TECHNOVIEW INC
Assignee - Original: TechnoView Inc.
Assignee - Original w/address: TechnoView Inc.,Newport Beach,CA,US
Assignee Count: 1
Inventor: Brown, Eric W. | Littlefield, James A.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W. | Littlefield, James A.
Inventor - w/address: Brown Eric W.,Newport Beach,CA,US | Littlefield James A.,Boston,MA,US
Inventor Count: 2
Attorney/Agent: Spensley Horn Jubas & Lubitz
Attorney/Agent - w/Address: Spensley Horn Jubas & Lubitz
Correspondent:
Correspondent - w/Address:
Examiner: Hoff, Marc S.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1996-01-30
Publication Month: 01
Publication Year: 1996
Application Number: US1994181605A
Application Country: US
Application Date: 1994-01-13
Application Month: 01
Application Year: 1994
Application with US Provisional: US1994181605A | 1994-01-13
Priority Number: US199369029A
Priority Country: US
Priority Date: 1993-05-28
Priority Date - Earliest: 1993-05-28
Priority Month: 05
Priority Year(s): 1993
Earliest Priority Year: 1993
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US199369029A
1993-05-28
US5359327A
1994-10-25
Continuation-in-part
Granted
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: G05F000318, H03M000108, H03M000112
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
G05F000318
G
G05
G05F
G05F0003
G05F000318
H03M000108
H
H03
H03M
H03M0001
H03M000108
H03M000112
H
H03
H03M
H03M0001
H03M000112
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current

G05F 3/18
H03M 1/089

H03M 1/12


20130101
20130101

EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 341119, 327326, 341139, 341141
US Class (divided): 341/119, 327/326, 341/139, 341/141
US Class - Main: 341119
US Class - Original: 341119 | 327326 | 341139 | 341141
ECLA: G05F000318, H03M000108W, T03M000112
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent: Maxim, .+-. 18-Bit ADC with Serial Interface Max 132 Manual, May, 1992. | RDP, Letter and Brochure for Datacom Distributed Intellegent Data Acqusition System, Sep., 1993. | Maxim, .+-. 18-Bit ADC with Serial Interface Max 132 EV Kit Manual, Jul., 1992.
Count of Cited Refs - Non-patent: 3
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0 (Examiner)
Title: Conversion using a variable reference based on image density
Count of Cited Refs - Patent: 23
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
CN102457278A
2012-05-16
SERAFIM TECHNOLOGIES INC
EP2634793A2
2013-09-04
THERMO FINNIGAN LLC
US20110127256A1
2011-06-02
-
US20120139219A1
2012-06-07
MUN SUNG HO
US5914629A
1999-06-22
SONY CORP
US6307496B1
2001-10-23
DENSO CORP
US6446019B1
2002-09-03
INTEL CORP
US6556155B1
2003-04-29
TEXAS ADVANCED OPTOELECTRONIC
US6847319B1
2005-01-25
STANDARD MICROSYST SMC
US6873306B2
2005-03-29
IBM
US6979804B1
2005-12-27
MAYTAG CORP
US6999012B2
2006-02-14
SAMSUNG ELECTRONICS CO LTD
US7423610B2
2008-09-09
LENOVO SINGAPORE PTE LTD
Count of Citing Patents: 13
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2000-04-11
FP
-
Description: EXPIRED DUE TO FAILURE TO PAY MAINTENANCE FEE 2000-01-30
2000-01-30
LAPS
-
Description: LAPSE FOR FAILURE TO PAY MAINTENANCE FEES
1999-08-24
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1994-01-13
AS
-
Description: ASSIGNMENT TECHNOVIEW, INC., CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNORS:BROWN, ERIC W.; LITTLEFIELD, JAMES A.; REEL/FRAME:006857/0165; SIGNING DATES FROM 19940109 TO 19940111
Post-Issuance (US): EXPI Expiration 2000-01-30 2000 Jan. 30, 2000 due to failure to pay maintenance fees
Maintenance Status (US): E1
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
TECHNOVIEW INC.,NEWPORT BEACH,CA,US
BROWN, ERIC W.
1994-01-09
006857/0165
1994-01-13
LITTLEFIELD, JAMES A.
1994-01-11
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: PAUL H. KOVELMAN, ESQ. SPENSLEY HORN JUBAS & LUBITZ 1880 CENTERY PARK EAST, FIFTH FLOOR LOS ANGELES, CALIFORNIA 90067-1605
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
TECHNOVIEW INC.,NEWPORT BEACH,CA,US
BROWN, ERIC W.
1994-01-09
006857/0165
1994-01-13
LITTLEFIELD, JAMES A.
1994-01-11
Reassignment (US) - Conveyance - Latest: ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: PAUL H. KOVELMAN, ESQ. SPENSLEY HORN JUBAS & LUBITZ 1880 CENTERY PARK EAST, FIFTH FLOOR LOS ANGELES, CALIFORNIA 90067-1605
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
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License (EP) - Licensee name:
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Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US5488368A
19960130
Brown Eric W.
TECHNOVIEW INC
Title: A/D converter system and method with temperature compensation
US5359327A
19941025
Brown Eric W.
BROWN ERIC W
Title: A/D converter system with interface and passive voltage reference source
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US5488368A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US5488368A_&format=gif&fponly=1
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Record 3/43
US5131816ACartridge fed programmable ambulatory infusion pumps powered by DC electric motors
Publication Number: US5131816A  
Title: Cartridge fed programmable ambulatory infusion pumps powered by DC electric motors
Title (Original): Cartridge fed programmable ambulatory infusion pumps powered by DC electric motors
Title (English): Cartridge fed programmable ambulatory infusion pumps powered by DC electric motors
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Infusion pump system with multi:fluid cartridge has programmable controller for linear peristaltic pumps outputting to manifold
Abstract:


A cartridge fed infusion pump containing a plurality of linear peristaltic pumps. Each pump is powered by a direct current motor. The motor has a shaft which rotates to perform a pump cycle. A position encoder mounted on the shaft is used to determine when the shaft has reached the stop position in the pump cycle. A reverse pulse is used to quickly stop the motor shaft.
Abstract (English):

A cartridge fed infusion pump containing a plurality of linear peristaltic pumps. Each pump is powered by a direct current motor. The motor has a shaft which rotates to perform a pump cycle. A position encoder mounted on the shaft is used to determine when the shaft has reached the stop position in the pump cycle. A reverse pulse is used to quickly stop the motor shaft.
Abstract (French):
Abstract (German):
Abstract (Original):

A cartridge fed infusion pump containing a plurality of linear peristaltic pumps. Each pump is powered by a direct current motor. The motor has a shaft which rotates to perform a pump cycle. A position encoder mounted on the shaft is used to determine when the shaft has reached the stop position in the pump cycle. A reverse pulse is used to quickly stop the motor shaft.
Abstract (Spanish):
Claims:

We claim:
1. An infusion pump system comprising: *
a fluid source cartridge including a pump interface portion containing a plurality of linear fluid conduits each being connected to an output port and a fluid source portion from which fluid is provided to said plurality of fluid conduits; *
a pump housing having a plurality of linear peristaltic pumps each having a set of pump fingers, the sets of pump fingers being arranged on a common base; and *
means for receiving said fluid source cartridge onto said housing adjacent the common base such that each of said linear fluid conduits aligns with one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
2. The infusion pump system of claim 1 wherein said output ports communicate with a multilumen output tube which connects to a multilumen connector means.
3. The infusion pump system of claim 1 wherein said output ports communicate with a manifold which feeds all fluids into a single output lumen.
4. The infusion pump system of claim 1 further comprising a programmable controller in said pump housing for individually controlling each of said peristaltic pumps thereby permitting sequential operation of the pumps at individually selected pumping rates.
5. The infusion pump system of claim 1 further comprising a clamp in the pump interface portion of said cartridge for securing said cartridge to said pump housing.
6. The infusion pump system of claim 5 wherein said clamp comprises a pair of clamp posts, each clamp post having a clamp head for insertion into said pump housing and means for changing said clamp posts between an open and a closed position.
7. The infusion pump system of claim 1 further comprising: *
a plurality of clamp posts extending from the pump interface portion of said cartridge, each post carrying an expandable member for insertion into said pump housing; and *
means for pulling on said clamp posts to expand said expandable members and to secure said cartridge to said pump housing.
8. The infusion pump system of claim 7 further comprising a support extending beneath the pump interface portion and connected to said clamp posts such that when said clamp posts are pulled to secure said cartridge, said support helps rigidify the pump interface portion a fixed distance from said pump.
9. The infusion pump system of claim 1 wherein each of said linear peristaltic pumps is operated by a direct current motor which rotates a motor shaft.
10. The infusion pump system of claim 9 further comprising along with each motor shaft, a position encoder rotatable in conjunction with its respective shaft for identifying a repeatable stop position for said shaft.
11. The infusion pump system of claim 9 wherein each of said direct current motors is selectively operable in a forward or reverse direction, the reverse direction being operable to quickly stop said motor.
12. The infusion pump system of claim 1 further comprising within said pump housing: *
a power supply line coupled to a battery; *
a diode coupled between said battery and said power supply line; and *
a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
13. An infusion pump comprising: *
a motor operable to rotate a motor shaft; *
means for driving said motor; *
a pump mechanism actuated by said motor shaft; *
a fluid supply line situated relative to said pump mechanism so as to be acted on by said pump mechanism such that when said motor shaft is rotating, fluid is moved through said supply line; *
processor means for initiating said driving means at selected intervals defined by a whole number of clock cycles to achieve a desired infusion rate which corresponds to intervals equal to the whole number and a calculated fracitonal value of clock cycles; and *
a memory location for storing a number representative of the fraction of a clock cycle and for accumulating the calculated fractional value at each pump cycle, so that when the accumulated sum reaches at least 1.0, an additional clock cycle is temporarily added to the whole number of clock cycles in the selected interval.
14. The infusion pump of claim 13 further comprising a position encoder rotatable in conjunction with said motor shaft for identifying a repeatable stop position for said shaft.
15. The infusion pump of claim 14 further comprising optical means for reading said position encoder and for sending a stop signal to said driving means when said motor shaft has completed a pump cycle.
16. The infusion pump of claim 15 wherein said optical means monitors said position encoder when said driving means is not being operated to ensure that said motor shaft has remained in the stop position.
17. The infusion pump of claim 13 wherein said pump mechanism comprises a plurality of finger members forming a linear peristaltic pump.
18. The infusion pump of claim 13 wherein said driving means is operable to selectively drive said motor in a forward or reverse direction, the reverse direction being usable to quickly stop said motor.
19. The infusion pump of claim 13 further comprising a battery for supplying power to said motor and a circuit for comparing current required by said motor with a reference which is a function of the voltage supplied by said battery for detecting an occlusion in said fluid supply line.
20. The infusion pump of claim 13 further comprising a power supply line coupled to a battery; a diode coupled between said battery and said power supply line; and a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
21. The infusion pump of claim 13 wherein said motor comprises a direct current motor.
22. A multiple fluid infusion pump comprising: *
a plurality of direct current motors each operable to rotate a motor shaft; *
means for driving each of said motors; *
a plurality of pump mechanisms arranged on a common base, each including a set of pump fingers which reciprocate through the base upon actuation by one of said motor shafts; and *
a plurality of fluid supply lines, each situated relative to one of said pump mechanisms so as to be acted on by its respective pump mechanism such that when the motor associated with said pump mechanism is rotating, fluid is moved through said supply line.
23. The multiple fluid infusion pump of claim 22 wherein said pump is an ambulatory pump.
24. The multiple fluid infusion pump of claim 22 wherein each of said pump mechanisms comprises a plurality of finger members forming a linear peristaltic pump.
25. The infusion pump of claim 22 wherein each of said driving means is operable to selectively drive its respective motor in a forward or reverse direction, the reverse direction being usable to quickly stop said motor.
26. The infusion pump of claim 22 further comprising a power supply line coupled to a battery; a diode coupled between said battery and said power supply line; and a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
27. An infusion pump comprising: *
a housing having a platform; *
a plurality of linear peristaltic infusion pumps, each pump having a plurality of pump fingers, said pumps being arranged in said housing so that said pump fingers reciprocate in and out through said platform; and *
means for receiving a plurality of linear fluid conduits such that each of said linear fluid conduits aligns with the pump fingers of one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
28. The infusion pump of claim 27 further comprising a programmable controller in said housing for individually controlling each of said peristaltic pumps thereby permitting sequential operation of the pumps at individually selected pumping rates.
29. The infusion pump of claim 27 further comprising a manifold in communication with each of said fluid conduits for feeding all fluids into a single output lumen.
30. The infusion pump of claim 27 wherein each of said linear peristaltic pumps includes a direct current motor for rotating a shaft which is used to cause said pump fingers to reciprocate.
31. The infusion pump of claim 27 wherein each plurality of pump fingers is arranged parallel to one another in said platform.
32. The infusion pump of claim 27 further comprising: *
a power supply line extending within said housing for coupling to a battery; *
a diode coupled between said battery and said power supply line; and *
a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply and said diode preventing said battery from being charged by said power supply line.
33. The infusion pump of claim 27 further comprising a plurality of position encoders each rotatable in conjunction with one of said motor shafts for identifying a repeatable stop position for said shaft and a plurality of optical means each for reading said position encoder and for sending a stop signal to said driving means when said motor shaft has completed a pump cycle.
Claims Count: 33
Claims (English):

We claim:
1. An infusion pump system comprising: *
a fluid source cartridge including a pump interface portion containing a plurality of linear fluid conduits each being connected to an output port and a fluid source portion from which fluid is provided to said plurality of fluid conduits; *
a pump housing having a plurality of linear peristaltic pumps each having a set of pump fingers, the sets of pump fingers being arranged on a common base; and *
means for receiving said fluid source cartridge onto said housing adjacent the common base such that each of said linear fluid conduits aligns with one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
2. The infusion pump system of claim 1 wherein said output ports communicate with a multilumen output tube which connects to a multilumen connector means.
3. The infusion pump system of claim 1 wherein said output ports communicate with a manifold which feeds all fluids into a single output lumen.
4. The infusion pump system of claim 1 further comprising a programmable controller in said pump housing for individually controlling each of said peristaltic pumps thereby permitting sequential operation of the pumps at individually selected pumping rates.
5. The infusion pump system of claim 1 further comprising a clamp in the pump interface portion of said cartridge for securing said cartridge to said pump housing.
6. The infusion pump system of claim 5 wherein said clamp comprises a pair of clamp posts, each clamp post having a clamp head for insertion into said pump housing and means for changing said clamp posts between an open and a closed position.
7. The infusion pump system of claim 1 further comprising: *
a plurality of clamp posts extending from the pump interface portion of said cartridge, each post carrying an expandable member for insertion into said pump housing; and *
means for pulling on said clamp posts to expand said expandable members and to secure said cartridge to said pump housing.
8. The infusion pump system of claim 7 further comprising a support extending beneath the pump interface portion and connected to said clamp posts such that when said clamp posts are pulled to secure said cartridge, said support helps rigidify the pump interface portion a fixed distance from said pump.
9. The infusion pump system of claim 1 wherein each of said linear peristaltic pumps is operated by a direct current motor which rotates a motor shaft.
10. The infusion pump system of claim 9 further comprising along with each motor shaft, a position encoder rotatable in conjunction with its respective shaft for identifying a repeatable stop position for said shaft.
11. The infusion pump system of claim 9 wherein each of said direct current motors is selectively operable in a forward or reverse direction, the reverse direction being operable to quickly stop said motor.
12. The infusion pump system of claim 1 further comprising within said pump housing: *
a power supply line coupled to a battery; *
a diode coupled between said battery and said power supply line; and *
a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
13. An infusion pump comprising: *
a motor operable to rotate a motor shaft; *
means for driving said motor; *
a pump mechanism actuated by said motor shaft; *
a fluid supply line situated relative to said pump mechanism so as to be acted on by said pump mechanism such that when said motor shaft is rotating, fluid is moved through said supply line; *
processor means for initiating said driving means at selected intervals defined by a whole number of clock cycles to achieve a desired infusion rate which corresponds to intervals equal to the whole number and a calculated fracitonal value of clock cycles; and *
a memory location for storing a number representative of the fraction of a clock cycle and for accumulating the calculated fractional value at each pump cycle, so that when the accumulated sum reaches at least 1.0, an additional clock cycle is temporarily added to the whole number of clock cycles in the selected interval.
14. The infusion pump of claim 13 further comprising a position encoder rotatable in conjunction with said motor shaft for identifying a repeatable stop position for said shaft.
15. The infusion pump of claim 14 further comprising optical means for reading said position encoder and for sending a stop signal to said driving means when said motor shaft has completed a pump cycle.
16. The infusion pump of claim 15 wherein said optical means monitors said position encoder when said driving means is not being operated to ensure that said motor shaft has remained in the stop position.
17. The infusion pump of claim 13 wherein said pump mechanism comprises a plurality of finger members forming a linear peristaltic pump.
18. The infusion pump of claim 13 wherein said driving means is operable to selectively drive said motor in a forward or reverse direction, the reverse direction being usable to quickly stop said motor.
19. The infusion pump of claim 13 further comprising a battery for supplying power to said motor and a circuit for comparing current required by said motor with a reference which is a function of the voltage supplied by said battery for detecting an occlusion in said fluid supply line.
20. The infusion pump of claim 13 further comprising a power supply line coupled to a battery; a diode coupled between said battery and said power supply line; and a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
21. The infusion pump of claim 13 wherein said motor comprises a direct current motor.
22. A multiple fluid infusion pump comprising: *
a plurality of direct current motors each operable to rotate a motor shaft; *
means for driving each of said motors; *
a plurality of pump mechanisms arranged on a common base, each including a set of pump fingers which reciprocate through the base upon actuation by one of said motor shafts; and *
a plurality of fluid supply lines, each situated relative to one of said pump mechanisms so as to be acted on by its respective pump mechanism such that when the motor associated with said pump mechanism is rotating, fluid is moved through said supply line.
23. The multiple fluid infusion pump of claim 22 wherein said pump is an ambulatory pump.
24. The multiple fluid infusion pump of claim 22 wherein each of said pump mechanisms comprises a plurality of finger members forming a linear peristaltic pump.
25. The infusion pump of claim 22 wherein each of said driving means is operable to selectively drive its respective motor in a forward or reverse direction, the reverse direction being usable to quickly stop said motor.
26. The infusion pump of claim 22 further comprising a power supply line coupled to a battery; a diode coupled between said battery and said power supply line; and a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply line and said diode preventing said battery from being charged by said power supply line.
27. An infusion pump comprising: *
a housing having a platform; *
a plurality of linear peristaltic infusion pumps, each pump having a plurality of pump fingers, said pumps being arranged in said housing so that said pump fingers reciprocate in and out through said platform; and *
means for receiving a plurality of linear fluid conduits such that each of said linear fluid conduits aligns with the pump fingers of one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
28. The infusion pump of claim 27 further comprising a programmable controller in said housing for individually controlling each of said peristaltic pumps thereby permitting sequential operation of the pumps at individually selected pumping rates.
29. The infusion pump of claim 27 further comprising a manifold in communication with each of said fluid conduits for feeding all fluids into a single output lumen.
30. The infusion pump of claim 27 wherein each of said linear peristaltic pumps includes a direct current motor for rotating a shaft which is used to cause said pump fingers to reciprocate.
31. The infusion pump of claim 27 wherein each plurality of pump fingers is arranged parallel to one another in said platform.
32. The infusion pump of claim 27 further comprising: *
a power supply line extending within said housing for coupling to a battery; *
a diode coupled between said battery and said power supply line; and *
a receptacle for receiving a power jack to switch said power line into connection with said power jack instead of said battery, said diode permitting power to be provided by said battery until electrical contact is made between said power jack and said power supply and said diode preventing said battery from being charged by said power supply line.
33. The infusion pump of claim 27 further comprising a plurality of position encoders each rotatable in conjunction with one of said motor shafts for identifying a repeatable stop position for said shaft and a plurality of optical means each for reading said position encoder and for sending a stop signal to said driving means when said motor shaft has completed a pump cycle.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. An infusion pump system comprising: *
a fluid source cartridge including a pump interface portion containing a plurality of linear fluid conduits each being connected to an output port and a fluid source portion from which fluid is provided to said plurality of fluid conduits; *
a pump housing having a plurality of linear peristaltic pumps each having a set of pump fingers, the sets of pump fingers being arranged on a common base; and *
means for receiving said fluid source cartridge onto said housing adjacent the common base such that each of said linear fluid conduits aligns with one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
Independent Claims:
1. An infusion pump system comprising: *
a fluid source cartridge including a pump interface portion containing a plurality of linear fluid conduits each being connected to an output port and a fluid source portion from which fluid is provided to said plurality of fluid conduits; *
a pump housing having a plurality of linear peristaltic pumps each having a set of pump fingers, the sets of pump fingers being arranged on a common base; and *
means for receiving said fluid source cartridge onto said housing adjacent the common base such that each of said linear fluid conduits aligns with one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
13. An infusion pump comprising: *
a motor operable to rotate a motor shaft; *
means for driving said motor; *
a pump mechanism actuated by said motor shaft; *
a fluid supply line situated relative to said pump mechanism so as to be acted on by said pump mechanism such that when said motor shaft is rotating, fluid is moved through said supply line; *
processor means for initiating said driving means at selected intervals defined by a whole number of clock cycles to achieve a desired infusion rate which corresponds to intervals equal to the whole number and a calculated fracitonal value of clock cycles; and *
a memory location for storing a number representative of the fraction of a clock cycle and for accumulating the calculated fractional value at each pump cycle, so that when the accumulated sum reaches at least 1.0, an additional clock cycle is temporarily added to the whole number of clock cycles in the selected interval.
22. A multiple fluid infusion pump comprising: *
a plurality of direct current motors each operable to rotate a motor shaft; *
means for driving each of said motors; *
a plurality of pump mechanisms arranged on a common base, each including a set of pump fingers which reciprocate through the base upon actuation by one of said motor shafts; and *
a plurality of fluid supply lines, each situated relative to one of said pump mechanisms so as to be acted on by its respective pump mechanism such that when the motor associated with said pump mechanism is rotating, fluid is moved through said supply line.
27. An infusion pump comprising: *
a housing having a platform; *
a plurality of linear peristaltic infusion pumps, each pump having a plurality of pump fingers, said pumps being arranged in said housing so that said pump fingers reciprocate in and out through said platform; and *
means for receiving a plurality of linear fluid conduits such that each of said linear fluid conduits aligns with the pump fingers of one of said linear peristaltic pumps so that for each fluid conduit, fluid is pumped by one of said linear peristaltic pumps.
Description:

BACKGROUND OF THE INVENTION

This invention relates to a programmable cartridge fed ambulatory infusion pump powered by a DC electric motor.

It is an object of this invention to provide a compact, lightweight infusion pump which may be used for ambulatory patients. It is a further object of this invention to provide a pump which can be conveniently used with fluid source cartridges.

There has been a demonstrated need for pumps which can intravenously administer a plurality of drug solutions. For example, multiple drug chemotherapy treatments have been used to treat diseases such as cancer. Many of the drugs used in chemotherapy and other therapies cannot be mixed together prior to an infusion. Some of these drugs react to neutralize one another. Other drugs react to form precipitates which may block the catheter tube or possibly cause an embolism in the patient. Pumps have been developed which can concurrently pump a plurality of fluids through a multilumen catheter into a patient. The multilumen catheter keeps the drugs separate until they reach the bloodstream. For example, in U.S. Pat. No. 4,741,736 (Brown), a pump is disclosed which uses a roller to push fluid out of a plurality of compartments in an infusion pump. The different fluids in each of the compartments are pumped out at the same time by the action of the single roller.

In infusion pump patent, U.S. Pat. No. 4,666,430 (Brown and Tai) , a multiple syringe pump is disclosed in which a canister of compressed gas serves as the power source for pumping fluid out of a syringe. All of the syringes are controlled by the same canister of gas and variation in the pumping rate of a syringe is controlled by valves on the outlets of the syringes.

It is an object of the present invention to provide in a single ambulatory housing, separately and accurately controlled pumping mechanisms for each of a plurality of fluid sources. It is typical in infusion pumps where accurate infusion rates are desired to use a stepper motor. However, in providing an ambulatory pump, it is desirable to use smaller, lighter motors such as the dc electric motors of the present invention. A further object of the present invention is to provide controlled infusion rates with dc electric motors.

In order to deliver fluid at a precisely determined rate through a linear peristaltic pump, the pump value must be accurately positioned with respect to the fluid delivery tube. Any warping of the cartridge or any mispositioning of the pump may permit a leak when a pump valve is depressed against the tube. It is an object of this invention to provide a cartridge and tube mount which accurately position a tube within an infusion pump. It is desirable that accuracy be obtained using low cost plastic pieces.

SUMMARY OF THE INVENTION

The present invention is directed to an infusion pump system including a fluid source cartridge which is attachable to a pump housing. The pump housing has a plurality of linear peristaltic pumps. Fluids may be stored in the cartridge or provided through the cartridge from an external source such as an IV bag mounted on a pole. The cartridge has a linear fluid conduit which aligns with the peristaltic pump for each fluid when the cartridge is inserted into the housing. The conduits are provided in what is called herein the pump interface portion of the cartridge. The pumping of fluid through any of the fluid conduits in the cartridge is controlled by that conduit's respective peristaltic pump.

The infusion pump housing may be advantageously provided with a programmable controller to permit individual control over each of the peristaltic pumps. This permits operating the pump sequentially or concurrently and at any selected pumping rate.

The pump according to the present invention is operated by a direct current motor. A position encoder rotatable in conjunction with the shaft of the motor provides an indication of a full cycle of the motor. Thus, by controlling the time delay between each motor cycle, the infusion pump rate can be controlled. The motor can be operated in reverse to assist it in stopping at the stop position indicated by the position encoder.

To provide accurate positioning of fluid pump tube with respect to the infusion pump, the cartridge of the present invention is provided with a handle clamp. The clamp is located in the pump interface portion of the cartridge. The clamp includes a bar which gives support to the pump interface portion, thereby holding the pump tubes firmly in position against the infusion pump.

Other objects and advantages of the present invention will become apparent during the following description of the presently preferred embodiment of the invention taken in conjunction with the drawings.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a pump and a cartridge of the present invention.

FIG. 2 is a second isometric view of the cartridge and pump of the present invention.

FIG. 3 is a bottom plan view of a pump of the present invention without the cartridge in place.

FIG. 4 is a side cross-sectional view of a pump and the cartridge of the present invention.

FIG. 4A is a close-up view of the optical sensor and position encoder of the pump of FIG. 4.

FIG. 5 is a plan view of a cartridge for use in the present invention.

FIG. 6 is a side elevational view of the cartridge of FIG. 6.

FIG. 7 is an elevational view of the cartridge of FIG. 5

FIG. 8 is an isometric view of the underside of an infusion pump with a cartridge of the present invention inserted.

FIG. 9 is a partial cross-sectional view of the cartridge of the present invention inserted into an infusion pump with the clamp open.

FIG. 10 is a partial cross-sectional view of the pump and cartridge of FIG. 8 with the clamp closed.

FIG. 11 is a cross-sectional view of the rear portion of the pump and cartridge of FIG. 8.

FIG. 12 is an isometric view of a cartridge of the present invention for use with pole mounted fluid source pouches along with pump tube mounts.

FIG. 13 illustrates how a pump tube mount is inserted into the cartridge.

FIG. 14 is an isometric view of the pump tube mount attached to a fluid source pouch.

FIG. 15 is a plan view of the pump tube mount without the tube and its retaining rings.

FIG. 16 is an elevational view of the pump tube mount of FIG. 15.

FIG. 17 is an isometric view of a cartridge of the present invention for use with mini-bag fluid sources.

FIGS. 18A and 18B are a schematic of the circuitry for operating the pump motors.

FIG. 19 is a schematic of the electronic circuitry devoted to a single pump motor.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIG. 1, a pump housing 10 is provided for pumping fluid from a multiple fluid cartridge 20. The pump housing 10 is provided with a liquid crystal display 12, a keyboard 14 and as shown in FIG. 2, programming jack 16. The underside of the pump housing 10 forms a cavity for receiving the cartridge 20. The cavity extends through one end of the pump housing 10.

The cartridge 20 houses one or more pump tube mounts 24. The portion of the cartridge 20 housing the pump tube mounts 24 is referred to herein as the pump interface portion. The remainder of the cartridge is referred to as the fluid source portion. Each pump tube mount 24 is connected to a fluid source which is either stored in a bag or a pouch in the fluid source portion of the cartridge or stored on a bag hanging from an intravenous delivery pole. To connect with a bag hanging from a pole, the cartridge's fluid source portion may have a window through which tubing may be inserted to connect the bag with the tube mount. Each pump tube mount 24 includes a compressible tube 22 made from a material which is inert to the fluids which will be fed through the tube. At the outer end of the pump tube mount 24, a luer connector 26 serves as the outlet for delivering fluid into an output lumen.

Individual output lumens may be connected to each of the luer connectors 26. These lumens may remain separate or they may be fused together to form a multilumen tube for outputting the fluid to a connector for making connection with an implanted catheter, for example. The multilumen output tube may be connected to any of a variety of multilumen connectors. A needle connector may be used in which each lumen is connected to a hollow injection needle. The needle connector may be inserted through a silicone block to make connection with a connector for a multilumen catheter. Another option is a multilumen connector such as that described in co-pending U.S. Pat. application Ser. No. 07/178,673 filed on Apr. 7, 1988, now issued as U.S. Pat. No. 4,950, 255 owned by the same assignee as the present invention. The disclosure of said application is hereby incorporated by reference herein. A third possibility for the multilumen output tube is to connect each lumen separately to a luer connector so that individual connections can be made to four separate catheter lines.

An alternative connector for delivering fluid from the cartridge to a patient may be a single lumen manifold 28 as shown in FIG. 1. The manifold 28 can be provided with four connectors 30 for securely attaching to the luer connectors 26, extending from the cartridge. Each of these connections may then lead to a single lumen 32. When this type of connector is used, it is normal practice to make the fluid source furthest from the manifold output a flushing solution. With this arrangement, the pump generally delivers one solution at a time or one fluid in conjunction with the flushing solution. Before switching from one solution to another, the flushing solution is delivered to clean out the single lumen so as to prevent intermixing of different fluid solutions. This would be necessary in the case of drugs which are either incompatible or which cause precipitation when mixed.

The cartridge 20 is provided with several positioning tabs 34 which extend from the rear end of the cartridge. The tabs 34 are inserted into holes located in the rear of the cavity of the pump. The engagement of the tabs 34 with the holes secures one end of the cartridge in the pump 10. The other end is secured by clamp heads 25 whose operation will be discussed in greater detail with respect to FIGS. 8-11.

The cartridge 20 may be used with a pump having a key operated latch 36. The latch 36 engages a tab 38 extending from the rear end of the cartridge 20. The latch 36 is used as a lock to prevent tampering with the drug solutions stored within the cartridge.

FIG. 2 illustrates flexible pouches 44 used as the fluid sources within the cartridge 20. Each fluid source pouch 44 is connected to a pump tube mount 24. At present, the following procedure is suggested for using the cartridge 20 when it is provided with empty pouches 44. The desired fluid is injected into the connector outlet 26, using a syringe or other conventional means. After filling the pouch 44 with the desired amount of fluid, the connector outlet 26 is attached to the output line. When all of the pouches are filled with their fluid, the cartridge may be inserted into the pump housing 10 and a purge cycle may be run on each of the fluid sources to pump out all of the air which may have gotten into the pouch or pump tube. After purging the air, the cartridge 20 is ready for use in an infusion.

Referring now to FIGS. 3 and 4, the presently preferred pump for use with the present invention is provided with a plurality, four in this case, of linear peristaltic pumps. The illustrated pump is a three finger pump, called such because of the three cams which are repeatedly lowered and raised to provide the desired pumping action. Each pump rotates a cam shaft 56 which selectively pushes against three cam followers or "fingers", including an output valve 46, a pump plunger 48 and an input valve 50. Power for the pump may be provided by a battery pack which can be loaded into a cavity behind a battery cover 52 alongside the peristaltic pumps within the housing 10. Alternatively, power can be provided through a jack 17. Each pump is provided with its own motor 54 which turns a cam shaft 56. In accordance with the present invention, each motor 54 is a direct current electric motor. The cam shaft 56 is provided with a timing disk or position encoder 58 shown in greater detail in FIG. 4A. The timing disk is solid except for a sector which is removed. The disk can thus be read by an optical sensor circuit 152 on a printed circuit board 60 to count the rotations, thereby controlling the rate and location of the cam shaft 56. The optical sensor includes a light emitting diode 57 and a photodetector 59.

To maintain improved accuracy, the cam followers should be made to always press against the tube 22, even when in the open position. The pump tube 22 is supported relative to the cam followers by a rigid base 67. A clamp, including clamp handle 69 and clamp heads 25, ensures that the rigid base 67 is always positioned a fixed distance from the cam followers on the pump.

Pumping is performed as follows. With the pump plunger 48 and the input valve 50 retracted, the output valve 46 is lowered to close off the fluid conduits. This permits the pump tube 22 to fill with fluid. This is the preferred position whenever the pump is inactive. In this position, the open sector of the position encoder is aligned with the light emitting diode and photo receiver. Next, the input valve 50 is lowered to close off the pump tube 22 and prevent fluid from flowing back into the fluid source 44. The cam shaft is then turned permitting the tube 22 to expand, pushing the output valve 46 to open. The pump plunger 48 is activated by the cam shaft to push fluid out of the tube 22 and through the outlet 26. Then the output valve 46 is again closed. The pump plunger 48 and the input valve 50 are permitted to open, thereby allowing the pump tube to refill with fluid. Thus, fluid is pumped out of the fluid source. The pump tube in the presently preferred embodiment has an inner diameter of 0.086 inches, an outer diameter of 0. 156 inches and a 50 durometer Shore A. The rate of pumping is controlled by knowing the precise volume pumped in each cycle and monitoring the number of pumping cycles per unit of time. The presently preferred embodiment pumps 50 microliters in each pump cycle.

A programmable microprocessor is provided on a control circuit board 76. Each of the four pump motors is controlled by the motor control board 60 and the controller board 76. The control circuits are described in greater detail below with respect to FIGS. 18 and 19. Since each fluid source has its own pump and pump motor, the rate and sequence of fluid infusion is entirely flexible. With a sufficient power source, infusions may take place concurrently or sequentially and at any rate. The present embodiment can pump fluid anywhere between 0.01 and 200 milliliters per hour. The desired sequence and rates of infusion are programmed into the controller board 76 through the programming jack 16. Thus, in accordance with the present pump, multiple fluid infusion treatments may be delivered to a patient in any number of sequences and rates. Thus, the pump provides physicians with great latitude for selecting multiple-fluid drug regimens for treating patient illnesses.

Referring now to FIGS. 5-7, the cartridge 20 shall be described in greater detail. The cartridge of the presently preferred embodiment is made of polycarbonate. FIG. 5, illustrates a cartridge 20 of the type with a window 62. The window provides a hole through which tubing can be fed to connect the pump tubes 22 with fluid sources. A discontinuous dividing wall 64 separates the cartridge 20 into a pump interface portion 66 and a fluid source portion 68. The fluid source portion 68 may provide fluids through a window such as that shown in FIG. 5. Alternatively, the fluid source portion 68 may be filled with fluid source pouches 44. With the pouches 44, the cartridge 20 can be used by an ambulatory patient. The cartridge 20 with a window 62 permits the same pump apparatus to be used with a pole mounted infuser and IV bags. Alternatively, the fluid source portion 68 of the cartridge 20 can be made extra deep, as shown in FIG. 17, to provide room for drug solution mini-bags. Such mini-bags provide more volume of fluid than the pouches 44. The mini-bag cartridge of FIG. 17 includes an inclined floor to help urge the fluid in the mini-bags towards the opening in the bottom of the bag. As such, the pump apparatus can be used with the mini-bags to provide a portable infusion apparatus which can be used by a patient undergoing high fluid volume infusions in the home. The mini-bag cartidge is provided with an opening for access to its clamp handle. A ring 71 may be attached to the handle for easier operation in pulling the handle open.

Referring to FIG. 6, a ledge 75 is formed by the dividing wall 64. The ledge 75 has an upper edge 77 at the level of the base of the pump interface portion of the cartridge. The ledge 75 has a lower edge 78 or a series of individual lower edges 78 which are provided for engaging the pump tube mounts.

The end wall 70 of the cartridge has a series of uniquely shaped openings 80 which accommodate the outlet ends of the pump tube mounts. Immediately behind each opening 80 is a retaining stump 82. The opening 80 is shaped to secure the front wall 84 of the pump tube mount in two directions. The front wall 84 is prevented from moving up and down or left and right when installed within the cartridge opening 80. Furthermore, the opening 80 is given a unique shape as if it were a lock for a key. Just as a key may be uniquely designed to fit into a lock, the front wall 84 of a pump tube mount can be uniquely shaped to fit the unique shape of the opening 80. This feature helps to ensure that only the appropriate tube mounts are inserted into the cartridge. The retaining stump 82 prevents the wall from moving back into the cartridge. The final direction of freedom is secured by the interaction of the rear wall of the pump mount with the ledge 75 of the cartridge.

Referring now to FIGS. 8-10, the mechanics for holding the cartridge in place against the pump shall be described. A clamp is located in the pump interface portion of the cartridge. Since this is where the pump tubes are located, it is critical that this portion of the cartridge be repeatably and accurately positioned and held against the infusion pump. It is important that the pump interface portion 66 of the cartridge 20 be held in a fixed position against the pump, since if the position is off it is possible that one of the pump fingers would not fully close off a pump tube as required to provide precise infusion rates.

The clamp includes two clamping posts 81 each with a clamp head 25. The clamping posts and clamp head are made of stainless steel in the presently preferred embodiment. Surrounding each clamping post 81 beneath its clamp head 25 is a compressible elastomeric tube 83, made of silicone in the presently preferred embodiment. The clamping post 81 may be formed by a screw 85 and threaded shaft 87 as shown in FIG. 9. Alternatively, the clamping post 81 may be a single rod with a flaired top portion as shown in FIG. 10. The clamp head 25 in FIG. 9 is formed by a washer 89 and the head of the screw 85. The clamp head 25 is formed about the flaired top of the rod in FIG. 10. The clamping posts 81 are axially movable within mounting walls 91 in the pump interface portion of the cartridge.

At the end of each clamping post 81 extending through the bottom of the cartridge 20, is inserted an expansion pin 93. The expansion pins 93 act as an axle about which the clamp handle 69 can be rotated. The pins 93 engage a hole in the clamp handle which is positioned so as to be a short distance from one edge and a longer distance from a second edge. As shown in FIG. 9, when the handle 69 is protruding out from the cartridge, the expansion pin 93 is between the handle and the edge which is a short distance from the pin. Thus, the pin is held a short distance from the bottom side of the pump interface portion of the cartridge. When the clamp handle 69 is pushed against the cartridge, the expansion pin 93 is pulled on until the clamp handle 69 rests on its side. With the handle on its side against the cartridge the expansion pin 93 has been pulled into a second position in which it is a longer distance from the bottom side of the pump interface portion. In this second position, the clamp head 25 is pulled down against the silicone tube 83. The tube 83 is compressed axially and expands radially. The tube 83 expands filling a countersunk hole 95 in the infusion pump base.

When the clamp is in the locked position as shown in FIGS. 8 and 10, the expansion pins 93 pull the clamp handle 69 upwards and the clamp head downwards. This secures the pump interface portion a fixed distance from the infusion pump base. The clamping action is sufficiently strong so that any affects of the pump fingers are insignificant. Additional support may be provided by an inner bar 97 which is a part of the handle 69 stretching between the clamping posts. The handle 69 and inner bar 97 are made from Delron in accordance with the presently preferred embodiment. The handle with its inner bar 97 extends across all four of the pump tube locations. Thus, the pull of the clamp is directly applied underneath each of the pump tubes. In this manner, the clamp of the present invention advantageously rigidifies and supports the base under each of the pump tubes maintaining the base at an accurate distance from the pump fingers.

FIG. 11 shows the engagement of the rear portion of a cartridge 20 with the pump housing. In order to insert a cartridge 20 into an infusion pump, the rear edge is inserted first. Tabs 34 are inserted into mating holes 99 in the pump housing 10. Then the pump interface portion of the cartridge is swung up into place. The clamp heads 25 enter the pump housing 10 through the countersunk holes 95 when the cartridge 20 is properly positioned. When the cartridge is in place, the clamp handle 69 is pushed against the cartridge to secure the cartridge in place. The key operated latch 36 may also be secured against the cartridge to protect against unauthorized access to the drug solutions in the cartridge.

The pump tube mounts for insertion into a cartridge are shown in FIGS. 12-16. The front wall 84 of a pump tube mount can be seen in FIG. 12. The front wall 84 is shaped so as to mate with the openings 80 in the cartridge. Extending from the front wall 84 is an outlet 26 which is preferably a female luer connector. Two side walls 86 connect the front wall 84 to a rear wall 88. The rear wall 88 of the pump tube mount extends downward below the base 67 of the pump tube mount. At the lower end of the rear wall 88 is a pair of tabs 90 which engage the lower edge 78 of the ledge 75 in the cartridge 20. The dividing wall 64 in the cartridge 20 is discontinuous providing openings for each of the pump tube mounts. Also illustrated in FIG. 12 is a bag spike 92, which is inserted into a bag of fluid solution hanging from a pole to connect the pump with the fluid solution.

FIG. 13 shows how the pump tube mount is inserted into the cartridge. The rigid base 67 beneath the pump tube 22 does not extend all the way to the front wall or the rear wall. At the front wall, this provides a space into which the retaining stump 82 can be extended. Thus, the first step, is to position the front wall 84 up against the stump 82. The rear wall 88 is then lowered over the ledge 75 in the cartridge 20. As the rear wall 88 is lowered, the front wall 84 pivots into place within the opening 80. The rear wall 88 is lowered until the tabs 90 snap into the openings beneath the lower edge 78. The rear wall 88 is located so as to fit snugly against the ledge 75. Thus, when the tabs 90 have not yet been lowered into the openings beneath the edge 78, the tabs 90 are forcing the rear wall 88 away from its normal resting position. Once the tabs get beneath the lower edge 78, the rear wall 88 is free to resume its resting position and therefore springs back against the ledge to make a snapping noise. The snap can be heard and felt so as to reassure the user that the pump tube mount is correctly positioned. The engagement of the tabs and the lower edge 78 keeps the pump tube mount in its correct position. When in place, the rear wall 88 against the ledge 75 prevents the pump tube mount from moving forward. This, in combination with the retaining stump 82 and the opening 80 securely holds the pump tube mount in a known position in three dimensions.

FIG. 14 illustrates a disposable pump tube mount. The tube mount, according to the presently preferred embodiment, is made of polycarbonate. The pump tube mount shown is attached to a flexible fluid source pouch 44. The fluid source pouch 44 may be adhesively bound to an inlet 94 extending from the rear wall 88 of the pump tube mount. A luer cap 96 may be screwed on to the luer connector 26 when the tube mount is not hooked up to an output line.

In FIG. 15, the pump tube mount is shown without a tube 22. Extending inwards from the front wall and the rear wall 88 is a fitting 98. The fitting 98 has a cylindrical exterior portion which makes surface contact with the inner circumference of the tube 22. The surface contact provides a frictional force between the fitting 98 and the inner circumference of the tube 22. In certain applications, this frictional force may be sufficient to hold the tube on the fittings. The presently preferred material for the tube 22 is Dow Corning medical-grade silicone.

Further force to hold the pump tube on the fitting may be provided by a barb extending from the fitting to dig in and hold onto the tube. Alternatively, in accordance with the presently described embodiment, an indentation such as an annular groove 100 is made in the cylindrical fitting 98. If the tube 22 fits tightly enough over the fitting 98, the silicone will slightly extend into the groove 100. This will provide an edge against the fitting which will hold the tube in place. To ensure that the silicone is depressed into the groove 100, a collar 102 may be placed over the tube concentrically aligned with the groove 100. The engagement of the tube with the groove provides adequate resistance against the shear forces created by the pumping action. The collar 102 is preferably a rigid material which is sized to compress the silicone into the groove 100. The collar 102 may be made from a material such as PVC or stainless steel.

Referring now to FIG. 16, the rigid base 67 is shown. The base 67 is supported by the sidewalls 86 of the pump tube mount. As can be seen in FIG. 16, there is a space between the rigid base 67 and the front wall 84 into which the stump 82 can extend. In operation, the base 67 rests against the bottom of the pump interface portion of the cartridge and is securely held in position by the clamp which extends across the pump interface portion.

The electronics for operating a direct current motor in the infusion pump of the present invention shall be described with reference to FIGS. 18A, 18B and 19. The program functions of the infusion pump are controlled by a microprocessor 110. The presently preferred microprocessor is an 80C31. A connection is provided between the microprocessor 110 and a serial I/0 interface 112. The serial interface provides for bi-directional communication between the programmable infusion pump and attached equipment. Applications for the serial I/0 interface include 1) the receipt of an infusion schedule from an external programmer, 2) external initiation of a self-test mode with transmission of the self-test status, 3) external initiation of diagnostic functions, and 4) externally triggered events such as a schedule stop or a special infuse sequence.

The microprocessor operates the liquid crystal display 12 through an LCD controller. The presently preferred LCD controller is a Philips PCF 2111.

A status port 116 interacts with the keypad 14 and battery monitor 118. The battery monitor 118 detects when the battery is either low, dead or not inserted.

The internal battery 120 may be used to supply power to the circuitry. A power jack 17 permits the pump to be run on external power rather than using the battery 120. The voltage provided by the battery or power jack is indicated as V.sub.BAT. A schottky diode reduces V.sub. BAT about a quarter of a volt to get .sub.V cc which is used by most of the circuitry. When a plug 123 for providing power is fully inserted into the power jack 17 a switch 122 is forced open, breaking its contact. The power for the programming circuitry is then maintained by the external source. In order to avoid an undesirable break in the provision of power to the infusion pump when an external plug 123 is inserted into the power jack 17, a diode 124 is connected to the battery 120. When a battery is installed in the infusion pump, current can pass from the battery through the diode 124. When a power plug is inserted into the jack 17, a non-conducting end 125 of the plug may contact the switch and break the switch contact before electrical connection is made between the plug and the power line for the circuitry. When the switch is broken the battery continues to provide power through the diode 124 thereby avoiding a temporary loss of power. Once electrical contact is made between the external source and the power line, power is essentially provided by the external source and the diode 124 prevents the external power source from charging the non-rechargeable battery 120.

A timing signal is provided to the microprocessor 110 by a 1. 8432 megaHertz oscillator 126.

A wake-up timer 128 divides the 32,768 Hz signal from an oscillator 130 so that a reset signal is delivered each sixteenth of a second from the wake-up timer to the microprocessor. The microprocesor is awakened each sixteenth of a second at which point it cycles through its control program. The microprocessor 110 manipulates and monitors counters to generate delays inserted between each motor startup to obtain a desired infusion rate. Each time the motor is started, it performs a complete pump cycle. Given a fixed volume of fluid delivered for a pump stroke, an infusion rate can be converted into a delay time between pump cycles. The delay time for the desired infusion rate for each pump is input into the pump control board through the programming jack 16. For example, a flow rate of 200 ml/hr converts to a delay of 14. 4 sixteenths of a second for a stroke volume of 0.05 ml.

The processor keeps track of the whole and fractional cycles separately. If the cycle count is a whole number such as 14.0, then every fourteeen sixteenths of a second, (every 14 cycle periods), the motor will be started in a microprocessor program cycle. When a fractional cycle is required for a given rate, the fraction value is accumulated until it exceeds 1. Then, an additional cycle is added to the cycle count. For the case where the cycle time is 14.4 sixteenths, a first motor cycle will begin after 14 sixteenths. 4/10 is carried over. The next pump cycle will be started after the next 14 sixteenths. Again, 4/10 is added to the fraction accumulator, leaving 0.8 as the accumulated total. Fourteen clock periods later the motor will be started again. This time when the 4/10 is added to the accumulator, unity is exceeded with an additional fraction of 2/10. An additional cycle is added to the cycle count so that the next motor cycle will not begin until 15 clock periods later. The succeeding cycle will again have a cycle count of 14, until the fractional accumulator exceeds unity. Thus, for a pumping time of 14. 4 sixteenths, the sequence will be 14, 14, 14, 15, 14, 14, 15. This will provide a sufficiently accurate infusion rate.

The fail safe timer makes sure that the motors are not operated if the microprocessor is not working properly. The microprocessor resets the fail safe timer each control program cycle, that is, each sixteenth of a second. Should the fail safe timer not be reset within a one second period, its output will stop the motors and the microprocessor will generate an error message.

Memory 134 is provided to work in conjunction with the microprocessor 110. The memory 134 includes EPROM for the permanent program storage and RAM for temporary storage of program instructions to control infusion and for general memory use. An address latch and decode circuit 136 is provided for interfacing the microprocessor 110 with the memory 134 and status port 116. The lower 8 bits of the microprocessor's address are multiplexed with the data bus, so the address must be latched synchronously with the address latch enable signal in order to distinguish it from data. The decoder portion of circuit 136 allows the microprocessor to enable any chosen one of the devices on the data bus.

The microprocessor 110 operates the motor control and an audio signaller 138. The audio signal may be generated in response to an alarm condition or to annunciate events such as a key press or serial link connect. Communication with the various motors in the infusion pump is handled through the output circuitry 140 and the input circuitry 142. The motor control input output circuitry communicates with the motors over a bus 144.

Each of the motors in the infusion pump is provided with circuitry for driving and controlling that motor. The circuit details of the presently preferred embodiment are shown in FIG. 19 for all of the motor driving control circuitry. The circuitry is the same for each one of the motors. A start signal from the microprocessor is received and latched in the control latch 146. This is passed to the one shot 148 where a signal is produced for operating a motor drive 150 in the forward direction. On the forward direction transistors Q2 nd Q5 shown in FIG. 19 are biased on. The motor drive may be an H bridge circuit so that it can produce a positive or negative signal to the motor.

The motor rotates in response to the signal from the motor drive 150 remaining on until the stop position is reached, as indicated by the optical sensor. The optical sensor 152 includes a light emitting diode 57 and a photodetector 59, which in the presently preferred embodiment is a phototransistor. When the motor shaft is in the stop position, the light from the LED is visible to the phototransistor and a signal is provided by the sensor indicating that the motor shaft is in its stop position. Once the motor shaft moves, the open sector in the position encoder rotates away from the optical sensing region and the solid portion of the position encoder blocks the light from the LED to the phototransistor 59. Once a complete cycle of the motor shaft has been made, an open sector of the position encoder reaches the optical sensing portion and the light from the LED becomes once again visible to the phototransistor. Thus, the optical sensor produces a signal indicating the stop position has been reached.

This stop signal resets the control latch 146, removing drive from Q2 and Q5. When the control latch 146 is reset, its output signal to the one shot 148 goes high and a signal opposite in polarity to the start signal is provided by the one shot to the motor drive 150. This opposite polarity signal causes the motor drive to operate in reverse for a time controlled by the RC time constant of R4 and C2. In the presently preferred embodiment, the reverse signal operates for about 36 milliseconds. The optical sensor sends a "complete" signal to the microprocessor so that it knows a revolution has been completed.

The microprocessor is operating a counter, waiting for the complete signal to be returned within sixteen control program cycles. If it isn't, an error message is generated. When a motor is idle, compliance is confirmed by reading the optical sensor signal to ascertain shaft position. Should the optical sensor provide a signal indicating the motor shaft has moved from its stop position, an off-line error is displayed by the processor. Should the optical sensor signal subsequently indicate the stop position has been reached, it is assumed that the motor is in a run-a-way condition and an alarm and error display is generated. Idle state monitoring is performed during the normal program control cycle and so occurs at the 16 Hz rate.

An occlusion monitor 154 is also provided. If the motor is having difficulty turning because of an occlusion in the catheter line or some other blockage, a signal will be fed from the motor drive 150 to the occlusion monitor 154. Referring to FIG. 19, this will be in the form of an increase in the motor current which flows through a 1 ohm resistor, R17. The voltage across R17 is sensed at a time when the pump plunger 48 is maximally depressed, since the motor current is proportional to load, occlusion can be sensed by comparing the voltage across R17 to a level consistent with normal operation. Reference voltage VTH2 in the occlusion monitor 154 represents the normal level.

VTH2 is provided by the occlusion reference 155. Rather than provide a fixed VTH2, the reference circuit 155 makes VTH2 a function of the battery voltage. In this manner, occlusion sensing is not sensitive to changing battery voltage. VTH2 is taken from a voltage divider formed by resistors R23 and R81. The voltage across R17 is amplified and filtered by amplifier U3B. The gain of U3B can be set by the value of R14 to be consistent with the value of VTH2, thereby causing comparator U3A to change state at the proper level of occlusion. Comparator U3A provides an "occlude" output when the output of U2B exceeds the normal established by VTH2. This will cause a signal to be sent over the bus 144 to the microprocessor. On detection of the occlusion signal, the microprocessor will send a stop signal to the motor, suspend the current infusion schedule and display the error condition on the infuser display. Since an increase in current across R17 will be caused by starting or stopping the motor, the microprocessor will not check the occlusion signal during those time frames. The microprocessor is programmed to check the occlusion signal only when the motor is at the stage where it is pushing down on the pump plunger 48.

As demonstrated by the above description, it is possible with the present invention to use a direct current motor in conjunction with the position encoder so as to achieve accurate infusion rates. Since one complete cycle of the motor can be repeated with precision and since the volume of fluid pumped during a complete cycle is accurately determinable, the volume per unit time can be precisely controlled by the microprocessor controlled infusion pump of the present invention by regulating the number of pump cycles per unit time.

Of course, it should be understood that various changes and modifications to the preferred embodiment described above will be apparent to those skilled in the art. For example, a combination of dynamic braking and reverse pulsing could be used to stop the motor. Also, the brake pulse width and, therefore, the energy expended could be modified by use of other sensing positions on the motor output shaft. Hall effect sensors and small magnets could be used to sense shaft position. These and other changes can be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Irvine,CA,US
Assignee/Applicant First: I Flow Corporation,Irvine,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Irvine,CA,US
Assignee Count: 1
Inventor: Brown, Eric W. | Kienholz, Charles M. | Busak, Steven J. | Hayob, Wayne | Papic, Ferrell D.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W. | Kienholz, Charles M. | Busak, Steven J. | Hayob, Wayne | Papic, Ferrell D.
Inventor - w/address: Brown Eric W.,Newport Beach,CA,US | Kienholz Charles M.,San Dimas,CA,US | Busak Steven J.,Laguna Niguel,CA,US | Hayob Wayne,Mission Viejo,CA,US | Papic Ferrell D.,Orange,CA,US
Inventor Count: 5
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Bertsch, Richard A. / Scheuermann, David W.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1992-07-21
Publication Month: 07
Publication Year: 1992
Application Number: US1989351981A
Application Country: US
Application Date: 1989-05-15
Application Month: 05
Application Year: 1989
Application with US Provisional: US1989351981A | 1989-05-15
Priority Number: US1988216512A | US1989301628A
Priority Country: US | US
Priority Date: 1988-07-08 | 1989-01-24
Priority Date - Earliest: 1988-07-08
Priority Month: 07 | 01
Priority Year(s): 1988 | 1989
Earliest Priority Year: 1988
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US1988216512A
1988-07-08
US4950245A
1990-08-21
Continuation-in-part
Granted
P
US1989301628A
1989-01-24
US5011378A
1991-04-30
Continuation-in-part
Granted
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M000500, A61M0005142, A61M0005168
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M000500
A
A61
A61M
A61M0005
A61M000500
A61M0005142
A
A61
A61M
A61M0005
A61M0005142
A61M0005168
A
A61
A61M
A61M0005
A61M0005168
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current
Current
Current

A61M 5/14228
A61M 5/142




A61M 5/14244
A61M 5/16827
A61M 2205/12
Y10S 128/12

20130101
20130101
20130101
20130101

EP
EP
EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 417002, 128DIG12, 417012, 417018, 417045, 417234, 417474, 417478, 604065, 604153
US Class (divided): 417/002, 128/DIG12, 417/012, 417/018, 417/045, 417/234, 417/474, 417/478, 604/065, 604/153
US Class - Main: 417002
US Class - Original: 417002 | 417012 | 417018 | 417045 | 417234 | 417474 | 417478 | 604065 | 604153 | 128DIG12
ECLA: A61M0005142G6, A61M0005142, K61M0005168A11, K61M0005142P, K61M020512
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent:
Count of Cited Refs - Non-patent: 0
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US4950245A
1990-08-21
Brown Eric W.
I FLOW CORP
-
0 (Examiner)
Title: Multiple fluid cartridge and pump
US4705506A
1987-11-10
Archibald G. Kent
MINNESOTA MINING &amp; MFG
-
0 (Examiner)
Title: Multiple solution IV system with setup error protection
US4696671A
1987-09-29
Epstein Paul
OMNI FLOW INC
-
0 (Examiner)
Title: Infusion system having plural fluid input ports and at least one patient output port
US4673390A
1987-06-16
Archibald G. Kent
MINNESOTA MINING &amp; MFG
-
0 (Examiner)
Title: Multiple solution IV system
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1984-10-30
Kobayashi Susumu
TERUMO CORP
-
0 (Examiner)
Title: Medication infusion device
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1985-01-15
Borsanyi Alexander S.
AMERICAN HOSPITAL SUPPLY CORP
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Title: Linear peristaltic pumping apparatus and disposable casette therefor
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1981-06-25
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BAXTER TRAVENOL LAB
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0 (Examiner)
Title: MINIATURE INFUSION PUMP
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1989-02-28
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0 (Examiner)
Title: Pump control system for instantly reversing the drive motor
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1988-03-15
Tanaka Shigeru
NIKKISO CO LTD
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0 (Examiner)
Title: Transfusion apparatus
US4666430A
1987-05-19
Brown Eric W.
I FLOW CORP
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0 (Examiner)
Title: Infusion pump
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1985-12-17
Berg Harvey F.
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0 (Examiner)
Title: Drug delivery system
WO1989011302A1
1989-11-30
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0 (Examiner)
Title: INFUSION DEVICE WITH DISPOSABLE ELEMENTS
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1987-03-31
Tsuji Tsuyoshi
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0 (Examiner)
Title: Finger peristaltic infusion pump
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1985-02-12
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Title: Insulin infusion pump
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1979-03-06
Jassawalla Jal S.
ANDROS INC
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0 (Examiner)
Title: Cassette for intravenous delivery system
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1968-07-09
MARTIN BLUMENTRITT
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Title: MONOCHROMATOR
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1944-06-20
MARSH JACK C
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0 (Examiner)
Title: Surgical pump
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1988-02-16
Cannon Raymond E.
FISHER SCIENT GROUP INC
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0 (Examiner)
Title: Peristaltic pump with cam action compensator
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1987-04-14
Abbott Martyn S.
QUEST MEDICAL INC
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0 (Examiner)
Title: Infusion pump with disposable cassette
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1986-01-07
LaFond Margaret
LAFOND MARGARET
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0 (Examiner)
Title: Multiplesyringe pump
US4397639A
1983-08-09
Eschweiler Wilhelm
FERRING ARZNEIMITTEL GMBH
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Title: Device for the intermittent pulsatory application of fluid medicaments
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1982-07-20
Spivey David L.
SPIVEY DAVID L
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0 (Examiner)
Title: Method and apparatus for medication dispensing
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1946-12-10
HARPER LYNDUS E
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Title: Flexible tube pump
US4781548A
1988-11-01
Alderson Richard K.
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Title: Infusion pump system and conduit therefor
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1987-03-17
Berg Harvey F.
DELTEC SYSTEMS INC
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Title: Drug delivery system
US4273121A
1981-06-16
Jassawalla Jal S.
ANDROS INC
-
0 (Examiner)
Title: Medical infusion system
US4094318A
1978-06-13
Burke George K.
BURRON MEDICAL PROD INC
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0 (Examiner)
Title: Electronic control means for a plurality of intravenous infusion sets
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1986-07-10
Kaemmerer Erich Dr.med.
BERNARD GEB KAEMMERER INGRID
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0 (Examiner)
Title: Variable infusion device for medical purposes
DE2855713A1
1980-06-26
Doehn Manfred Priv.-Doz. Dr.med. 2000 Hamburg
DOEHN MANFRED PRIV DOZ DR MED
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Title: Vorrichtung zur Infusion von Loesungen aus mehreren Infusionsflaschen
EP204977A1
1986-12-17
Howson David C.
INTELLIGENT MEDICINE INC
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Title: Syringe drive apparatus
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1990-03-13
Howson David C.
IVION CORP
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Title: Failsafe apparatus and method for effecting syringe drive
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1990-01-02
Alderson Richard K.
ALDERSON RICHARD K
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0 (Examiner)
Title: Infusion pump system and conduit therefor
US4741736A
1988-05-03
Brown Eric W.
I FLOW CORP
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Title: Programmable infusion pump
US4657486A
1987-04-14
Stempfle Julius E.
STEMPFLE JULIUS E
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0 (Examiner)
Title: Portable infusion device
US4493704A
1985-01-15
Beard Robert W.
OXIMETRIX
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0 (Examiner)
Title: Portable fluid infusion apparatus
US4199307A
1980-04-22
Jassawalla Jal S.
ANDROS INC
-
0 (Examiner)
Title: Medical infusion system
US3778195A
1973-12-11
Bamberg George
BAMBERG G
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0 (Examiner)
Title: PUMP FOR PARENTERAL INJECTIONS AND THE LIKE
US4865584A
1989-09-12
Epstein Paul
OMNI FLOW INC
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0 (Examiner)
Title: Cassette for programable multiple input infusion system
US4756706A
1988-07-12
Kerns Ralph M.
AMERICAN HOSPITAL SUPPLY CORP
-
0 (Examiner)
Title: Centrally managed modular infusion pump system
US4728265A
1988-03-01
Cannon Raymond
FISHER SCIENT GROUP INC
-
0 (Examiner)
Title: Peristaltic pump with cam action compensator
US4718467A
1988-01-12
Di Gianfilippo Aleandro
BAXTER TRAVENOL LAB
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0 (Examiner)
Title: Pumping module arrangement and manifold
US4479761A
1984-10-30
Bilstad Arnold C.
BAXTER TRAVENOL LAB
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0 (Examiner)
Title: Actuator apparatus for a prepackaged fluid processing module having pump and valve elements operable in response to externally applied pressures
US4925371A
1990-05-15
Griesmar Andre R.
MILTON ROY DOSAPRO
-
0 (Examiner)
Title: Flow rate control for a variable stroke pump
US4741732A
1988-05-03
Crankshaw David P.
UNIV MELBOURNE
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0 (Examiner)
Title: Open-loop control of drug infusion
US4734092A
1988-03-29
Millerd Donald L.
IVAC CORP
-
0 (Examiner)
Title: Ambulatory drug delivery device
US4601700A
1986-07-22
Thompson Thomas C.
QUEST MEDICAL INC
-
0 (Examiner)
Title: METHOD FOR FLOW CONTROL MONITORING
Count of Cited Refs - Patent: 46
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GB2338759A
1999-12-29
BAXTER INT
US20090297362A1
2009-12-03
TXAM PUMPS LLC
US20100262002A1
2010-10-14
MALLINCKRODT INC
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1994-04-19
SHARP KK
US5338157A
1994-08-16
PHARMACIA DELTEC INC
US5368562A
1994-11-29
PHARMACIA DELTEC INC
US5406183A
1995-04-11
TOMOVIC; JOSEPH F
US5443451A
1995-08-22
BAXTER INT
US5447417A
1995-09-05
VALLEYLAB INC
US5460490A
1995-10-24
LINVATEC CORP
US5460493A
1995-10-24
BAXTER INT
US5482438A
1996-01-09
ANDERSON; ROBERT L
US5482446A
1996-01-09
BAXTER INT
US5485408A
1996-01-16
SIMS DELTEC INC
US5487649A
1996-01-30
AMERICAN HYDRO SURGICAL INSTR
US5509901A
1996-04-23
MILIJASEVIC; ZORAN
US5551850A
1996-09-03
BAXTER INT
US5593290A
1997-01-14
EASTMAN KODAK CO
US5609575A
1997-03-11
GRASEBY MEDICAL LTD
US5620312A
1997-04-15
SABRATEK CORP
US5628619A
1997-05-13
SABRATEK CORP
US5630710A
1997-05-20
BAXTER INT
US5637093A
1997-06-10
SABRATEK CORP
US5658133A
1997-08-19
BAXTER INT
US5658250A
1997-08-19
SIMS DELTEC INC
US5658252A
1997-08-19
SIMS DELTEC INC
US5766155A
1998-06-16
SABRATEK CORP
US5772409A
1998-06-30
SIMS DELTEC INC
US5791880A
1998-08-11
SABRATEK CORP
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1998-08-18
SABRATEK CORP
US5904668A
1999-05-18
SABRATEK CORP
US5935099A
1999-08-10
SIMS DELTEC INC
US5993420A
1999-11-30
SABRATEK CORP
US6014578A
2000-01-11
MEOTRONIC INC
US6024539A
2000-02-15
SIMS DELTEC INC
US6077223A
2000-06-20
MEDTRONIC INC
US6115622A
2000-09-05
MEDTRONIC INC
US6119029A
2000-09-12
MEDTRONIC INC
US6128520A
2000-10-03
MEDTRONIC INC
US6141574A
2000-10-31
MEDTRONIC INC
US6142938A
2000-11-07
MEDTRONIC INC
US6154668A
2000-11-28
MEDTRONICS INC
US6186752B1
2001-02-13
BAXTER INT
US6189736B1
2001-02-20
NIAGARA PUMP CORP
US6200264B1
2001-03-13
MEDTRONIC INC
US6213739B1
2001-04-10
NIAGARA PUMP CORP
US6241704B1
2001-06-05
SIMS DELTEC INC
US6245013B1
2001-06-12
MEDTRONIC INC
US6468242B1
2002-10-22
BAXTER INT
US6475180B2
2002-11-05
SIMS DELTEC INC
US6985870B2
2006-01-10
BAXTER INT
US6997905B2
2006-02-14
BAXTER INT
US7018361B2
2006-03-28
BAXTER INT
US7347836B2
2008-03-25
SMITHS MEDICAL INC
US7431573B2
2008-10-07
BOSCH GMBH ROBERT
US7608060B2
2009-10-27
BAXTER INT
US7654976B2
2010-02-02
SMITHS MEDICAL ASD INC
US7668731B2
2010-02-23
BAXTER INT
US7704231B2
2010-04-27
ARES TRADING SA
US7967784B2
2011-06-28
ARES TRADING SA
US8105269B2
2012-01-31
ZHOU YU
US8133197B2
2012-03-13
BLOMQUIST MICHAEL
US8137083B2
2012-03-20
ZHOU YU
US8149131B2
2012-04-03
BLOMQUIST MICHAEL L
US8241018B2
2012-08-14
HARR JAMES
US8250483B2
2012-08-21
BLOMQUIST MICHAEL L
US8287495B2
2012-10-16
MICHAUD MICHAEL
US8298184B2
2012-10-30
DIPERNA PAUL M
US8376985B2
2013-02-19
ARES TRADING SA
US8382447B2
2013-02-26
BAXTER INT
US8435206B2
2013-05-07
EVANS WILLIAM JAMES
US8496613B2
2013-07-30
ZHOU YU
US8504179B2
2013-08-06
BLOMQUIST MICHAEL L
US8567235B2
2013-10-29
BOJAN PETER M
US8602746B2
2013-12-10
GALLWEY BRADY
US8613726B2
2013-12-24
CAUSEY III JAMES D
US8696632B2
2014-04-15
GILLESPIE JR JOHN
US8758323B2
2014-06-24
MICHAUD MICHAEL
US8771251B2
2014-07-08
RUCHTI TIMOTHY LEWIS
US8858526B2
2014-10-14
BLOMQUIST MICHAEL L
US8882481B2
2014-11-11
HARR JAMES
US8888738B2
2014-11-18
GILLESPIE JR JOHN
US8926561B2
2015-01-06
VERHOEF ERIK T
US8952794B2
2015-02-10
BLOMQUIST MICHAEL L
US8954336B2
2015-02-10
BLOMQUIST MICHAEL L
US8965707B2
2015-02-24
BLOMQUIST MICHAEL L
US8986253B2
2015-03-24
DIPERNA PAUL M
USD350822S1
1994-09-20
Deka Products Limited Partnership
USD357312S1
1995-04-11
Hospal Industrie
USD376848S1
1996-12-24
Sabratek Corporation
USD380260S1
1997-06-24
Sabratek Corporation
WO1995024229A2
1995-09-14
BAXTER INT
WO1995024229A3
1995-10-26
BAXTER INT
WO2003051428A1
2003-06-26
DCA DESIGN INT LTD
Count of Citing Patents: 94
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2004-01-20
FPAY
+
Description: FEE PAYMENT
2000-01-21
FPAY
+
Description: FEE PAYMENT
1996-02-27
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1996-01-22
FPAY
+
Description: FEE PAYMENT
1990-02-23
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNOR:KIENHOLZ, CHARLES M.; REEL/FRAME:005459/0044 1989-07-05
1990-02-23
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNORS:BROWN, ERIC W.; HAYOB, WAYNE; PAPIC, FERRELL D.; REEL/FRAME:005459/0040 1990-06-06
Post-Issuance (US):
Maintenance Status (US):
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,IRVINE,CA,US
BROWN, ERIC W.
1990-06-06
005459/0040
1990-02-23
HAYOB, WAYNE
1990-06-06
PAPIC, FERRELL D.
1990-06-06
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, & CUSHMAN 130 WATER STREET BOSTON, MA 02109
I-FLOW CORPORATION,IRVINE,CA,US
KIENHOLZ, CHARLES M.
1989-07-05
005459/0044
1990-02-23
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, & CUSHMAN 130 WATER STREET BOSTON, MA 02109
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,IRVINE,CA,US
BROWN, ERIC W.
1990-06-06
005459/0040
1990-02-23
HAYOB, WAYNE
1990-06-06
PAPIC, FERRELL D.
1990-06-06
Reassignment (US) - Conveyance - Latest: ASSIGNMENT OF ASSIGNORS INTEREST.
Reassignment (US) - Corresponent - Latest: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, & CUSHMAN 130 WATER STREET BOSTON, MA 02109
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
License (EP) - License date:
EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US5131816A
19920721
Brown Eric W.
I FLOW CORP
Title: Cartridge fed programmable ambulatory infusion pumps powered by DC electric motors
EP354324A2
19900214
Brown Eric W.
I FLOW CORP
Title: Cartridge-type programmable ambulatory infusion pump
EP354324A3
19901003
Brown Eric W.
I-FLOW CORPORATION
Title: Cartridge-type programmable ambulatory infusion pump
JP4082564A
19920316
BROWN ERIC W
AI FUROO CORP
Title: INJECTION PUMP DEVICE
US4950245A
19900821
Brown Eric W.
I FLOW CORP
Title: Multiple fluid cartridge and pump
US5011378A
19910430
Brown Eric W.
I FLOW CORP
Title: Pump tube mount and cartridge for infusion pump
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US5131816A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US5131816A_&format=gif&fponly=1
Record Source: Result Set
Top
Record 4/43
US4950255ACatheter connector and clamp
Publication Number: US4950255A  
Title: Catheter connector and clamp
Title (Original): Catheter connector and clamp
Title (English): Catheter connector and clamp
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Catheter connector and clamp has interlocking hook and post joining two parts together with manifold separating lumens of catheter
Abstract:


A combination catheter connector and clamp provided with an interlocking hook and post for locking two connector parts together. A manifold separates the lumens of a multilumen catheter into separate arms which can be closed or opened by a pushbutton clamp. A silicone block is used between the engagement portions of the connector parts.
Abstract (English):

A combination catheter connector and clamp provided with an interlocking hook and post for locking two connector parts together. A manifold separates the lumens of a multilumen catheter into separate arms which can be closed or opened by a pushbutton clamp. A silicone block is used between the engagement portions of the connector parts.
Abstract (French):
Abstract (German):
Abstract (Original):

A combination catheter connector and clamp provided with an interlocking hook and post for locking two connector parts together. A manifold separates the lumens of a multilumen catheter into separate arms which can be closed or opened by a pushbutton clamp. A silicone block is used between the engagement portions of the connector parts.
Abstract (Spanish):
Claims:

We claim:
1. A multilumen connector part comprising: *
a housing having a plurality of engagement parts at one end and means for receiving a multilumen catheter at an other end; *
a manifold having a plurality of compressible and resilient conduits within said housing, said manifold providing independent fluid communication between each lumen of said multilumen catheter and a different one of said conduits and said conduits each leading to a different one of said plurality of engagement ports; and *
clamping means attached to said housing for selectively closing off said plurality of conduits by pushing against all of said conduits in an area of said housing where said conduits are arranged in a non-overlapping manner.
2. The multilumen connector part of claim 1 wherein said clamping means comprises a pushbutton having flow restrictor members which close off said plurality of conduits when said pushbutton is held in a closed position.
3. The multilumen connector part of claim 2 wherein said pushbutton further includes guide members for riding up and down in slots formed in said housing.
4. The multilumen connector part of claim 2 wherein said pushbutton further includes a ledge engaging said housing to hold said pushbutton against said housing when said pushbutton is in a closed position.
5. The multilumen connector part of claim 1 further comprising post means extending from said housing so as to be available for making locking engagement with a second multilumen connector part.
6. The multilumen connector part of claim 1 further comprising a resilient sealing block secured within said housing for forming the engagement ports.
7. A catheter connector comprising: *
a first lock adapter including means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
a second lock adapter having an engagement portion connectable to said first lock adapter so that each said conduit in said first lock adapter interconnects with a conduit in said second lock adapter; *
post means extending out from one of said first or second lock adapters; and *
hook means attached to the other of said first or second lock adapters so that said first lock adapter is locked to said second lock adapter when said hook means engages said post means.
8. The catheter connector of claim 7 further comprising clamp means attached to said first lock adapter for selectively closing each said conduit in said first lock adapter.
9. The catheter connector of claim 8 wherein said clamp means comprises a pushbutton attached to said housing and flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
10. The catheter connector of claim 9 wherein said pushbutton further includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
11. The catheter connector of claim 7 wherein said hook means comprises a member having a hook at one end and a rotatable attachment at an other end.
12. The catheter connector of claim 7 wherein said second lock adapter further includes a penetrable self-sealing septum covering each conduit in said second lock adapter.
13. The catheter connector of claim 12 further comprising a needle holder having a needle for each conduit in said second lock adapter, each needle being insertable through said septum so as to be put in communication with a conduit in said second lock adapter.
14. The catheter connector of claim 7 further comprising a resilient sealing block for connecting the engagement portion of said second lock adapter to the engagement ports of said first lock adapter.
15. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
post means extending from said housing so as to be available for making locking engagement with a second catheter connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
16. The catheter connector part of claim 15 wherein said pushbutton further includes a ledge for engaging said housing to hold said pushbutton in the closed position.
17. The catheter connector part of claim 15 wherein said pushbutton includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
18. The catheter connector part of claim 15 further comprising a resilient sealing block for connecting the engagement ports of said housing with the engagement portion of a second catheter connector port.
19. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
hook means for making locking engagement with a second multilumen connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
20. The catheter connector part of claim 19 wherein said hook means comprises a member having a hook at one end and being rotatably attached to said housing at an other end.
21. The catheter connector part of claim 20 wherein said pushbutton includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
22. The catheter connector part of claim 20 further comprising a resilient sealing block for connecting the engagement ports of said housing with the engagement portion of a second catheter connector port.
23. The catheter connector part of claim 22 wherein said pushbutton further includes a ledge for engaging said housing to hold said pushbutton in the closed position.
Claims Count: 23
Claims (English):

We claim:
1. A multilumen connector part comprising: *
a housing having a plurality of engagement parts at one end and means for receiving a multilumen catheter at an other end; *
a manifold having a plurality of compressible and resilient conduits within said housing, said manifold providing independent fluid communication between each lumen of said multilumen catheter and a different one of said conduits and said conduits each leading to a different one of said plurality of engagement ports; and *
clamping means attached to said housing for selectively closing off said plurality of conduits by pushing against all of said conduits in an area of said housing where said conduits are arranged in a non-overlapping manner.
2. The multilumen connector part of claim 1 wherein said clamping means comprises a pushbutton having flow restrictor members which close off said plurality of conduits when said pushbutton is held in a closed position.
3. The multilumen connector part of claim 2 wherein said pushbutton further includes guide members for riding up and down in slots formed in said housing.
4. The multilumen connector part of claim 2 wherein said pushbutton further includes a ledge engaging said housing to hold said pushbutton against said housing when said pushbutton is in a closed position.
5. The multilumen connector part of claim 1 further comprising post means extending from said housing so as to be available for making locking engagement with a second multilumen connector part.
6. The multilumen connector part of claim 1 further comprising a resilient sealing block secured within said housing for forming the engagement ports.
7. A catheter connector comprising: *
a first lock adapter including means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
a second lock adapter having an engagement portion connectable to said first lock adapter so that each said conduit in said first lock adapter interconnects with a conduit in said second lock adapter; *
post means extending out from one of said first or second lock adapters; and *
hook means attached to the other of said first or second lock adapters so that said first lock adapter is locked to said second lock adapter when said hook means engages said post means.
8. The catheter connector of claim 7 further comprising clamp means attached to said first lock adapter for selectively closing each said conduit in said first lock adapter.
9. The catheter connector of claim 8 wherein said clamp means comprises a pushbutton attached to said housing and flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
10. The catheter connector of claim 9 wherein said pushbutton further includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
11. The catheter connector of claim 7 wherein said hook means comprises a member having a hook at one end and a rotatable attachment at an other end.
12. The catheter connector of claim 7 wherein said second lock adapter further includes a penetrable self-sealing septum covering each conduit in said second lock adapter.
13. The catheter connector of claim 12 further comprising a needle holder having a needle for each conduit in said second lock adapter, each needle being insertable through said septum so as to be put in communication with a conduit in said second lock adapter.
14. The catheter connector of claim 7 further comprising a resilient sealing block for connecting the engagement portion of said second lock adapter to the engagement ports of said first lock adapter.
15. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
post means extending from said housing so as to be available for making locking engagement with a second catheter connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
16. The catheter connector part of claim 15 wherein said pushbutton further includes a ledge for engaging said housing to hold said pushbutton in the closed position.
17. The catheter connector part of claim 15 wherein said pushbutton includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
18. The catheter connector part of claim 15 further comprising a resilient sealing block for connecting the engagement ports of said housing with the engagement portion of a second catheter connector port.
19. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
hook means for making locking engagement with a second multilumen connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
20. The catheter connector part of claim 19 wherein said hook means comprises a member having a hook at one end and being rotatably attached to said housing at an other end.
21. The catheter connector part of claim 20 wherein said pushbutton includes guide members which fit through slots formed in said housing, said guide members having expanded portions at their ends for preventing said guide members from coming out of the slots thereby maintaining said pushbutton attached to said housing.
22. The catheter connector part of claim 20 further comprising a resilient sealing block for connecting the engagement ports of said housing with the engagement portion of a second catheter connector port.
23. The catheter connector part of claim 22 wherein said pushbutton further includes a ledge for engaging said housing to hold said pushbutton in the closed position.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A multilumen connector part comprising: *
a housing having a plurality of engagement parts at one end and means for receiving a multilumen catheter at an other end; *
a manifold having a plurality of compressible and resilient conduits within said housing, said manifold providing independent fluid communication between each lumen of said multilumen catheter and a different one of said conduits and said conduits each leading to a different one of said plurality of engagement ports; and *
clamping means attached to said housing for selectively closing off said plurality of conduits by pushing against all of said conduits in an area of said housing where said conduits are arranged in a non-overlapping manner.
Independent Claims:
1. A multilumen connector part comprising: *
a housing having a plurality of engagement parts at one end and means for receiving a multilumen catheter at an other end; *
a manifold having a plurality of compressible and resilient conduits within said housing, said manifold providing independent fluid communication between each lumen of said multilumen catheter and a different one of said conduits and said conduits each leading to a different one of said plurality of engagement ports; and *
clamping means attached to said housing for selectively closing off said plurality of conduits by pushing against all of said conduits in an area of said housing where said conduits are arranged in a non-overlapping manner.
7. A catheter connector comprising: *
a first lock adapter including means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
a second lock adapter having an engagement portion connectable to said first lock adapter so that each said conduit in said first lock adapter interconnects with a conduit in said second lock adapter; *
post means extending out from one of said first or second lock adapters; and *
hook means attached to the other of said first or second lock adapters so that said first lock adapter is locked to said second lock adapter when said hook means engages said post means.
15. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
post means extending from said housing so as to be available for making locking engagement with a second catheter connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
19. A catheter connector part comprising: *
a housing having means for receiving a catheter having at least one lumen, an engagement port for each lumen and a conduit for each port connecting said port to one of said at least one lumen; *
hook means for making locking engagement with a second multilumen connector part; *
a pushbutton attached to said housing; and *
flow restrictor members extending from said pushbutton for closing off said conduits when said pushbutton is in a closed position.
Description:

BACKGROUND OF THE INVENTION

This invention relates to a combination catheter connector and clamp, in particular, one for use with multilumen catheters

It has been found convenient for patients who are receiving frequent infusions to provide them with a tunneled subcutaneous catheter. Such a catheter is inserted underneath the skin of the patient and then into a vein. A tissue cuff is provided on the catheter near the skin so that the skin may grow into it and hold the catheter in place. A connector part is located on the end of the catheter above the skin into which a mating connector part may be attached to connect the subcutaneously tunneled catheter with an external catheter. The external catheter may be used for infusion of fluids or for extraction of body fluid for testing A separate catheter clamp may be used in conjunction with such a catheter arrangement so as to permit closing off of the passageway through the catheter.

More recently, there has been an introduction of the use of multilumen catheters in subcutaneously tunneled catheter sets. For example, U.S. Pat. No. 4,581,012 discloses a multilumen locking connector for use in a subcutaneously tunneled catheter set. Clamping of such a multilumen catheter is difficult especially if repeated clamping is desired. A multilumen catheter has walls on its interior separating the plurality of lumens. These interior walls make it difficult to completely clamp off a multilumen catheter and the walls are further subject to being crushed or deteriorated from repeated clamping. It is one object of the present invention to provide a clamp for use in a multilumen catheter set.

SUMMARY OF THE INVENTION

The present invention is directed to a catheter connector including a first lock adapter for mating with a second lock adapter. A post extends from one adapter and a hook is attached to the other adapter so that when the hook engages the post, the two adapters become locked together.

In accordance with a feature of the present invention, the connector may be provided with a clamp for closing off the conduits through one of the adapters. The clamp can be conveniently formed by a push button which rides in a couple of slots in one of the lock adapters By providing a clamp in the connector, the present invention advantageously eliminates the need for separate clamps or a single clamp which may damage a multilumen catheter. Particularly advantageous is the use of the clamp in the multilumen embodiment of the present invention. The clamp is used to shut off the conduits within one of the lock adapters In this manner, no stress is exerted upon the interior walls of a multilumen catheter.

A further advantage of the present invention is that it may be provided with a self-sealing septum which gives the implanted catheter a closed system having no exposure to the air. The septum is penetrated by a needle for providing communication between an external catheter and the implanted catheter.

Other objects and advantages of the present invention will become apparent during the following description of the presently preferred embodiments of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of the combination catheter connector and clamp of the present invention.

FIG. 2 is an elevational view of the combination catheter connector and clamp of FIG. 1.

FIG. 3 is a plan view in partial cross-section of the combination catheter connector and clamp of FIG. 1.

FIG. 4 is an elevational view in partial cross-section of the multilumen catheter connector and clamp of FIG. 1.

FIG. 5 is an exploded view of an alternate embodiment of the combination catheter connector and clamp of the present invention.

FIG. 6 is a cross-sectional view of the patient connector part of the present invention.

FIG. 7 is a cross-sectional view of the patient connector part of FIG. 6 with the clamp in the open position.

FIG. 8 is a cross-sectional view of the patient connector part of FIG. 6 with the clamp in the closed position.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIGS. 1 and 2, the combination catheter connector and clamp is shown. A patient connector part 10 is lock adapter attached to a catheter 11 which has been implanted in a patient. A pushbutton clamp 12 is provided in the patient connector part 10 The patient connector part 10 includes conduits providing communication with the lumen or lumens in the implanted catheter 11. The pushbutton clamp 12 is used to close off the conduit or conduits within the patient connector part 10 so as to close off the implanted catheter 11. The patient connector part 10 further includes a locking post 14 which is used when the patient connector part 10 is locked onto a lock adapter referred to herein as the drug connector part 20. The drug connector part 20 is attached to an external catheter 21. The external catheter 21 could be used in connection with an infusion pump for infusing fluid into a patient through the implanted catheter.

The drug connector part 20 carries an interlock 22 which has a handle 24 and a hook 26. The interlock 22 is rotatably connected to the connector 20 about shafts 28. The interlock 22 is shown in solid lines in the locked position with the hook 26 engaging the locking posts 14 of the patient connector 10. The locking posts 14 may be made in the shape of a cross or other equivalent shape to form a ledge that positively engages the hook 26. In the locked position, the lumens of the implanted catheter 11 are in communication through the connector with the lumens of the external catheter 21. The connector can be unlocked by squeezing the connector parts together and pulling up on the handle 24 which causes the interlock 22 to swing about the axis formed by the shafts 28 thereby disengaging the hook 26 from the posts 14. The interlock 22 is drawn in dashed lines to show it in an unlocked position.

The patient connector 10 is described in more detail with reference to FIGS. 3 and 4. A plastic housing 30 includes an engagement portion 32 top and bottom manifold covers 34 and a hinge portions 33 connecting the manifold covers to the engagement portion 32. The engagement portion 32 provides solid conduit tubes 38 for each conduit provided by the connector. A connector is chosen for a catheter so that there is one conduit for each lumen in the catheter. In accordance with the preferred embodiment, a resilient sealing block 36 provides the engagement ports 35 for the patient connector part 10. The sealing block 36, preferably made from silicone, is solid except for a conduit for each of the conduits in the connector. The conduits fit over the solid conduit tubes 38 projecting from the engagement portion 32 of the housing 30. Rather than using the hard plastic conduit tubes as engagement ports, the silicone block is used since it is resilient and can therefore accomodate slight manufacturing variations in the formation of the plastic connector parts or deviations created by handling and use of the plastic connector parts. In this manner, it is easier to ensure that two connector parts can be mated.

On the inside of the housing 30, a manifold 40 is placed for providing fluid communication between the conduit tubes 38 and the lumens of the catheter connected to the connector. The extruded catheter tube is molded to the manifold 40 so that each lumen is separately directed through an independent conduit. Each conduit branches off into one of the plurality of arms 42 on the manifold 40. The manifold 40 and its arms 42 are made of a compressible and resilient material such as silicone so as to properly respond to the action of the clamp 12 Silicone is also preferable because of its known compatibility to various drugs and body tissues. Each arm 42 of the manifold 40 fits over the rear of a conduit tube 38 to provide a separate and distinct conduit for each lumen of the catheter from the junction between the catheter and the manifold 40 through to the engagement ports formed by the silicone block 36.

The top manifold cover 34 has a hole 47 through which the pushbutton clamp 12 fits. The bottom manifold cover 34 is provided with two slots 48 within which the pushbutton clamp 12 rides. Referring now to FIGS. 6-8, the pushbutton clamp 12 includes two guide members 50 which ride up and down in the slots 48. The guide members 50, each includes a restraint portion 52 at its end. The restraint portion is expanded with respect to the guide member in order to prevent the pushbutton 12 from coming out of the slots 48 The restraint portion may be formed in the mold for the push button clamp or alternatively the bottoms of the guide members can be heat staked to form the restraint portions after the molding process. The restraint portions 52 ride within a widened portion 49 of the slots. The restraint portions 52 hit up against a shoulder 54 where the widened portion 49 meets the narrow portion of the slots 48. This action as shown in FIGS. 6 and 7 keeps the clamp 12 secured onto the connector.

In manufacture of this connector, the top and bottom manifold covers 34 are swung open along the hinge portions 33. The manifold 40 molded to the patient catheter is attached to the rear of the conduit tubes 38. The top and bottom manifold covers 34 are then swung closed so as to envelope the manifold. The pushbutton clamp 12 is then inserted through the top manifold cover 34 into the slots 48. The restraint portions 52 of the clamp are forced through the narrow portion of the slots 48 until they snap into the widened portion 49. The silicone block 36 is then force fit onto the tubes 38.

The pushbutton clamp 12 further includes a flow restrictor member 56 for each of the arms 42 of the manifold. The flow restrictor members 56 are shorter than the guide members 50 so that when the button 12 is up as in FIGS. 6 and 7 the flow restrictor members 56 do not cause any restriction in the flow of fluids through the arms 42 of the manifold. The flow restrictor members 56 of the preferred embodiment are provided with a clamping ledge 58 which is provided for sliding under a restraining wall portion 60 of the upper manifold cover 34. Thus to effect clamping, the pushbutton 12 is pushed down and forward into the position shown in FIG. 4 so that the clamping ledge 58 engages the wall portion 60. In this position, the flow restrictor members 56 are held down against the arms 42 of the manifold 40 so as to close off the conduits there within as shown in FIG. 8. While the back of the clamp 12 may bow up off the connector housing, the parts are dimensioned to ensure complete closure of the conduits when the clamp is in the closed position.

The drug connector part 20 is now discussed in more detail. As in the patient connector part 10, the drug connector part 20 includes a silicone manifold 40 in this case molded to the external catheter 21. The manifold may be made of silicone or a medical-grade plastic, such as PVC. The arms of the silicone manifold 40 plug onto the interior projections of conduit tubes 62. The outer ends of conduit tubes 62 form the engagement ports for the drug connector part 20. These engagement ports fit into the conduits of the silicone block 36 carried by the patient connector part 10. Thus, the drug connector part provides a conduit for each of the lumens in the external catheter from the catheter through to the engagement ports at the outer ends of the conduit tubes 62. The resiliency of the silicone block 36 permits the engagement portion of the drug connector part 20 to fit over the block and the tube projections to fit into the conduits despite any minor manufacturing tolerances in the formation of the drug connector part. When the engagement ports of the connector parts are fully inserted into the silicone block, the interlock 22 can be brought down into place so that the hook 26 engages the post 14 of the patient connector. A slight compression of the silicone block occurs to ensure a good seal.

In accordance with an alternate embodiment of the present invention, rather than providing a drug connector part connected to a multilumen catheter, an injection connector part 70 may be used for interacting with a needle holder 78 as shown in FIG. 5. The needle holder 78 may be provided with single lumen lines 74 connected to injection ports 75 permitting the use of a syringe to repeatedly inject a drug solution through an injection port and into any one of the lumens of the patient catheter. The injection connector part 70 has a housing which surround conduit tubes 62. The conduit tubes 62 form the engagement ports at their outer ends as in the drug connector part. A silicone self-sealing septum 76 is provided for insertion into the rear of the housing 70 so that the rear of the conduit tubes 62 fit into matching holes in the septum 76. An interlock 22, not shown, is rotatably attached to the connector part housing at shafts 28. Thus, the injection connector part may be plugged into the patient connector part and locked thereto by the interlock 22. This will provide a closed system for the patient The self-sealing septum 76 will prevent air from entering the conduits which lead into the patient's multilumen catheter.

The needle holder 78 is provided with needles 80 aligned for insertion through the septum 76 and into the conduit tubes 62. When the septum 76 is penetrated by the needles, the needles extend through the septum to provide communication between the conduit tubes 62 and the single lumen lines 74 at the rear of the needles 80. Each needle 80 has a single lumen line 74 in communication therewith. The single lumen lines 74 are attached to the rear of the needle holder 78. At the other end of each catheter is a luer connector 82 which is provided with its own self-sealing septum 84. The septum 84 and luer connectors 82 form the injection ports 75. Injections may be made by a syringe needle through the self-sealing septum 84 of one of the single lumen lines connected at the rear of the needle holder 78. This permits selective injection of fluids into the individual lumens of an implanted multilumen catheter.

Of course, it should be understood that various changes and modifications to the preferred embodiments described above will be apparent to those skilled in the art. For example, a spring biased clamp may be used to replace the pushbutton clamp on the patient connector part. This and other changes can be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Irvine,CA,US
Assignee/Applicant First: I Flow Corporation,Irvine,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Irvine,CA,US
Assignee Count: 1
Inventor: Brown, Eric W. | Kienholz, Charles | Robinson, Earl F. | Bare, Rex O.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W. | Kienholz, Charles | Robinson, Earl F. | Bare, Rex O.
Inventor - w/address: Brown Eric W.,Newport Beach,CA,US | Kienholz Charles,San Dimas,CA,US | Robinson Earl F.,El Toro,CA,US | Bare Rex O.,Irvine,CA,US
Inventor Count: 4
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Sykes, Angela D.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1990-08-21
Publication Month: 08
Publication Year: 1990
Application Number: US1988178673A
Application Country: US
Application Date: 1988-04-07
Application Month: 04
Application Year: 1988
Application with US Provisional: US1988178673A | 1988-04-07
Priority Number: US1988178673A
Priority Country: US
Priority Date: 1988-04-07
Priority Date - Earliest: 1988-04-07
Priority Month: 04
Priority Year(s): 1988
Earliest Priority Year: 1988
Related Application Table:
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M003900, A61M003910, A61M003928, F16L003756
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M003900
A
A61
A61M
A61M0039
A61M003900
A61M003910
A
A61
A61M
A61M0039
A61M003910
A61M003928
A
A61
A61M
A61M0039
A61M003928
F16L003756
F
F16
F16L
F16L0037
F16L003756
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current
Current

F16L 37/56
A61M 39/10
A61M 39/284

A61M 2039/1027
A61M 2039/1077


20130101
20130101
20130101

EP
EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604250, 439372, 604533, 604283
US Class (divided): 604/250, 439/372, 604/533, 604/283
US Class - Main: 604250
US Class - Original: 604250 | 604283
ECLA: A61M003910, A61M003928C, F16L003756, K61M003910F, K61M003910W
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent:
Count of Cited Refs - Non-patent: 0
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US4701159A
1987-10-20
Brown Eric W.
I FLOW CORP
-
0 (Examiner)
Title: Multilumen catheter set
US4425113A
1984-01-10
Bilstad Arnold C.
BAXTER TRAVENOL LAB
-
0 (Examiner)
Title: Flow control mechanism for a plasmaspheresis assembly or the like
US3747632A
1973-07-24
Kok Albertus Jacobus Theodorus
IPP IND POLYMER PROCESSING SA
-
0 (Examiner)
Title: FLUID CONDUITS
CH830081A
-
-
-
-
0 (Examiner)
US4581012A
1986-04-08
Brown Eric W.
I FLOW CORP
YD
0 (Examiner)
Title: Multilumencatheter set
US4429852A
1984-02-07
Tersteegen Bernd
TERSTEEGEN BERND
-
0 (Examiner)
Title: Adapter
US4187846A
1980-02-12
Lolachi Houshang
UNION CARBIDE CORP
-
0 (Examiner)
Title: Sterile connectors
US4695273A
1987-09-22
Brown Eric W.
I FLOW CORP
-
0 (Examiner)
Title: Multiple needle holder and subcutaneous multiple channel infusion port
US4616802A
1986-10-14
Tseng Charles C.
BAXTER TRAVENOL LAB
-
0 (Examiner)
Title: Tubing occluder
US4367740A
1983-01-11
Evanoski III Constant J.
EVANOSKI III CONSTANT J
-
0 (Examiner)
Title: Combination catheter cystometer system and gastric feeding device
US4257416A
1981-03-24
Prager David
PRAGER DAVID
-
0 (Examiner)
Title: Multi-channel venipuncture infusion set
Count of Cited Refs - Patent: 11
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
CN102227234B
2014-06-18
ACIST MEDICAL SYS INC
DE29903286U1
2000-09-14
BRAUN MELSUNGEN AG
TWI403339B
2013-08-01
NESTEC SA
US5478119A
1995-12-26
KENDALL &amp; CO
US5868695A
1999-02-09
BAXTER INT
US5925023A
1999-07-20
NISSHO KK
US5993437A
1999-11-30
EPIMED INT INC
US6083205A
2000-07-04
INTELLA INTERVENTIONAL SYS INC
US6190372B1
2001-02-20
EPIMED INT INC
US6770057B2
2004-08-03
HEWLETT PACKARD DEVELOPMENT CO
US6910906B2
2005-06-28
CODMAN &amp; SHURTLEFF
US6969381B2
2005-11-29
MEDICAL COMPONENTS INC
US7163531B2
2007-01-16
BAXTER HEALTHCARE SA
US7344527B2
2008-03-18
MEDICAL COMPONENTS INC
US7387624B2
2008-06-17
MEDTRONIC INC
US7455072B2
2008-11-25
I FLOW CORP
US7661440B2
2010-02-16
I FLOW CORP
US7678101B2
2010-03-16
MEDTRONIC INC
US7758082B2
2010-07-20
NXSTAGE MEDICAL INC
US7914513B2
2011-03-29
MEDICAL COMPONENTS INC
US7914519B2
2011-03-29
ELCAM MEDICAL AGRICULTURAL COOPERATIVE ASS LTD
US7984929B2
2011-07-26
RENISHAW PLC
US8042838B2
2011-10-25
NXSTAGE MEDICAL INC
US8118061B2
2012-02-21
HYUN DONGCHUL D
US8157851B2
2012-04-17
ANDREAS BERNARD H
US8221388B2
2012-07-17
SWISHER DAVID R
US8267370B2
2012-09-18
FISHER MARK S
US8403004B2
2013-03-26
HYUN DONGCHUL D
US8419694B2
2013-04-16
BRAGA RICHARD M
US8523828B2
2013-09-03
CALLAHAN MARK
US8585096B2
2013-11-19
SCHNELL WILLIAM J
US8641210B2
2014-02-04
SHAFER HELEN ZINREICH
US8646921B2
2014-02-11
SHAFER HELEN ZINREICH
US8651274B2
2014-02-18
SHAFER HELEN ZINREICH
US8661573B2
2014-03-04
SHAFER HELEN ZINREICH
US8662684B2
2014-03-04
SHAFER HELEN ZINREICH
US8668342B2
2014-03-11
SHAFER HELEN ZINREICH
US8668343B2
2014-03-11
SHAFER HELEN ZINREICH
US8668344B2
2014-03-11
SHAFER HELEN ZINREICH
US8668345B2
2014-03-11
SHAFER HELEN ZINREICH
US8672490B2
2014-03-18
SHAFER HELEN ZINREICH
US8740877B2
2014-06-03
BORLAUG TOM
US8747371B2
2014-06-10
STREATFIELD GILL STEVEN
US8876798B2
2014-11-04
CLARK GEOFF
USD431651S1
2000-10-03
Incutech Inc.
USD661388S1
2012-06-05
CLARK GEOFF
USRE39499E1
2007-02-27
EPIMED INT INC
WO1994005353A1
1994-03-17
DEKNATEL TECH CORP
Count of Citing Patents: 48
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
2002-02-21
FPAY
+
Description: FEE PAYMENT
1998-02-23
FPAY
+
Description: FEE PAYMENT
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1994-02-07
FPAY
+
Description: FEE PAYMENT
1988-07-05
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION,CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNORS:ROBINSON, EARL, F.; BROWN, ERIC W.; BARE, REX O.; AND OTHERS; REEL/FRAME:004907/0795 1988-06-28
Post-Issuance (US):
Maintenance Status (US):
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
I-FLOW CORPORATION,IRVINE,CA,US
ROBINSON, EARL, F.
1988-06-28
004907/0795
1988-07-05
BROWN, ERIC W.
1988-06-28
BARE, REX O.
1988-06-28
KIENHOLZ, CHARLES
1988-06-28
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER STREET BOSTON, MA 02109
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
License (EP) - License date:
EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4950255A
19900821
Brown Eric W.
I FLOW CORP
Title: Catheter connector and clamp
EP340427A2
19891108
Brown Eric W.
I FLOW CORP
Title: Catheter connector and clamp
EP340427A3
19900919
Brown Eric W.
I-FLOW CORPORATION
Title: Catheter connector and clamp
JP2029270A
19900131
BROWN ERIC W
I FLOW CORP
Title: CONNECTOR FOR CATHETER
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4950255A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4950255A_&format=gif&fponly=1
Record Source: Result Set
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Record 5/43
US4759527AInfusion pump valve
Publication Number: US4759527A  
Title: Infusion pump valve
Title (Original): Infusion pump valve
Title (English): Infusion pump valve
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Infusion pump valve used during chemotherapy has flow restrictor positioned within central bore at open end of housing, restrictor being controlled by solenoids
Abstract:


An infusion pump is disclosed in which a canister of compressed gas is regulated to provide a continuous source of pressure to one or more compressible fluid sources. Valves on the outlets of the sources prevent fluid from escaping except when the valves are opened. The valves are opened by solenoids which are selectively activated to open the valves.
Abstract (English):

An infusion pump is disclosed in which a canister of compressed gas is regulated to provide a continuous source of pressure to one or more compressible fluid sources. Valves on the outlets of the sources prevent fluid from escaping except when the valves are opened. The valves are opened by solenoids which are selectively activated to open the valves.
Abstract (French):
Abstract (German):
Abstract (Original):

An infusion pump is disclosed in which a canister of compressed gas is regulated to provide a continuous source of pressure to one or more compressible fluid sources. Valves on the outlets of the sources prevent fluid from escaping except when the valves are opened. The valves are opened by solenoids which are selectively activated to open the valves.
Abstract (Spanish):
Claims:

We claim:
1. A disposable sterilizable valve comprising: *
a hollow housing having an open end, a partially closed end having an open slot with a length and a width which is shorter than the length, a central bore and an outlet providing an opening in the central bore through a side of said housing; *
a sealing member slidably mounted within said central bore; *
a plunger stem having one end connected to said sealing member and an other end extending through the open slot in the partially closed end of said housing, said plunger stem further including a cross-piece at its other end to make said other end T-shaped, said cross-piece having a length which is greater than the width of the open slot and less than the length of said open slot and having a width which is less than the width of the open slot; and *
a spring positioned in the central bore surrounding said plunger stem, one end of said spring pushing against the partially closed end of said housing and the other end of said spring pushing against said sealing member so as to force said sealing member into a position which closes the outlet.
2. The disposable valve of claim 1 further comprising a flow restrictor positioned within the central bore at the open end of said housing to restrict the flow of fluid between the open end of said housing and said central bore.
3. The disposable valve of claim 1 wherein said plunger stem is integral with said sealing member.
4. The disposable valve of claim 1 further comprising tab means extending from the open-end of said housing so as to form said housing into a female luer lock fitting.
Claims Count: 4
Claims (English):

We claim:
1. A disposable sterilizable valve comprising: *
a hollow housing having an open end, a partially closed end having an open slot with a length and a width which is shorter than the length, a central bore and an outlet providing an opening in the central bore through a side of said housing; *
a sealing member slidably mounted within said central bore; *
a plunger stem having one end connected to said sealing member and an other end extending through the open slot in the partially closed end of said housing, said plunger stem further including a cross-piece at its other end to make said other end T-shaped, said cross-piece having a length which is greater than the width of the open slot and less than the length of said open slot and having a width which is less than the width of the open slot; and *
a spring positioned in the central bore surrounding said plunger stem, one end of said spring pushing against the partially closed end of said housing and the other end of said spring pushing against said sealing member so as to force said sealing member into a position which closes the outlet.
2. The disposable valve of claim 1 further comprising a flow restrictor positioned within the central bore at the open end of said housing to restrict the flow of fluid between the open end of said housing and said central bore.
3. The disposable valve of claim 1 wherein said plunger stem is integral with said sealing member.
4. The disposable valve of claim 1 further comprising tab means extending from the open-end of said housing so as to form said housing into a female luer lock fitting.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A disposable sterilizable valve comprising: *
a hollow housing having an open end, a partially closed end having an open slot with a length and a width which is shorter than the length, a central bore and an outlet providing an opening in the central bore through a side of said housing; *
a sealing member slidably mounted within said central bore; *
a plunger stem having one end connected to said sealing member and an other end extending through the open slot in the partially closed end of said housing, said plunger stem further including a cross-piece at its other end to make said other end T-shaped, said cross-piece having a length which is greater than the width of the open slot and less than the length of said open slot and having a width which is less than the width of the open slot; and *
a spring positioned in the central bore surrounding said plunger stem, one end of said spring pushing against the partially closed end of said housing and the other end of said spring pushing against said sealing member so as to force said sealing member into a position which closes the outlet.
Independent Claims:
1. A disposable sterilizable valve comprising: *
a hollow housing having an open end, a partially closed end having an open slot with a length and a width which is shorter than the length, a central bore and an outlet providing an opening in the central bore through a side of said housing; *
a sealing member slidably mounted within said central bore; *
a plunger stem having one end connected to said sealing member and an other end extending through the open slot in the partially closed end of said housing, said plunger stem further including a cross-piece at its other end to make said other end T-shaped, said cross-piece having a length which is greater than the width of the open slot and less than the length of said open slot and having a width which is less than the width of the open slot; and *
a spring positioned in the central bore surrounding said plunger stem, one end of said spring pushing against the partially closed end of said housing and the other end of said spring pushing against said sealing member so as to force said sealing member into a position which closes the outlet.
Description:

BACKGROUND OF THE INVENTION

This invention relates to infusion pumps. There are many applications for which there is a need for a device which can intravenously administer a plurality of drug solutions. One such application is the use of chemotherapy to treat such diseases as cancer. Attempts at providing more advanced chemotherapy regimens involving the intravenous administration of a multiplicity of drug solutions are being inhibited by a lack of equipment to simplify such a procedure. Very often if different drug solutions are used, they are administered by using a separate catheter tube for each drug. A separate infusion pump would be used on each individual catheter tube line and the tube would deliver the fluid solution into the patient through its respective intravascular access needle. A patient must pay for each catheter set and must rent a pump for use with the catheter tube. Therefore, it is costly to use multiple catheter tubes and pumps.

Some physicians administer chemotherapy treatments with a plurality of drug solutions by mixing the solutions together and feeding the mixture into the patient through a single catheter set and pump. If the different drug solutions are compatible they can be mixed and delivered through a single catheter. Unfortunately, there are only a limited number of drug combinations which can be used in this manner. Many drugs cannot be mixed together prior to infusion. Some drugs react to neutralize one another. Other drugs react to form precipitates which may block the catheter tube or possibly cause an embolism in the patient.

It is desirable to provide a single pump that can deliver a multiplicity of drug solutions without mixing any of them prior to infusion. It is especially desirable for the pump to be lightweight so that it might be used on an ambulatory patient. U.S. Pat. No. 4,313,439 (Babb et al.) recognized the need for lightweight infusion pumps in a single drug delivery system. Babb et al. provided an escapement mechanism which applied a continuous pressure to a syringe. A constrictor acted on a catheter tube to prevent fluid from passing through the tube except during periods when the force from the constrictor was released to allow fluid through the tube.

SUMMARY OF THE INVENTION

This invention is directed to an infusion pump containing a compressible fluid source having an outlet which is normally blocked by a valve. A pressurized source of gas is fed through a pressure regulator and then against the fluid source to urge fluid against the valve. The valve may be opened to allow fluid to flow through the outlet.

The present invention is especially adapted for use with a plurality of compressible fluid sources. Control means are provided for selectively opening the valves to the sources. According to the present embodiment of the invention, a conduit is provided from the pressure regulator to the fluid source. The preferred sources are syringes. The syringes are sealed so that only the pressurized gas directed through the conduit is allowed into the tops of the syringes.

A disposable sterilizable valve of the present invention is connected to the bottom of each of the syringes. The valve of the present invention includes a hollow housing and a sealing member which is slidably mounted within a cylindrical bore inside the housing. The sealing member is connected to a plunger stem that has a T-shaped end which extends through a hollow slot in the bottom of the housing. A spring biases the sealing member away from the wall of the housing and into a closed position which prevents fluid from leaving through an outlet conduit in the side of the housing. The valve can be opened by pulling on the T-shaped end of the plunger stem. A flow restrictor is provided at the opposite end of the central bore to restrict the flow of fluid into the housing.

The pump of the present invention is light in weight since it is powered mostly by the pressurized gas. The only moving parts are the valves. This advantageously minimizes the chances of having any mechanical problems. Furthermore, this minimizes the need for electric power so that a very light battery package is sufficient to run the device. The construction of the present invention is easily adapted for use in multiple fluid infusions. The control means gives doctors a wide latitude in choosing their regimens, any of which may be programmed into the device.

Other objects and advantages of the invention will become apparent during the following description of the presently preferred embodiment of the invention, taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a substantially cut away view of the pump of the present invention.

FIG. 2 is a cross-sectional view of the pump of FIG. 1 taken along lines 2--2.

FIG. 3 is a perspective view of a syringe for use with the present invention.

FIG. 4 is a perspective view of the syringe of FIG. 3 with its needle and plunger stem removed.

FIG. 5 is a cross-sectional view of the valve of the present invention in the closed position.

FIG. 6 is a cross-sectional view of the valve of FIG. 5 in the open position.

FIG. 7 is a bottom view of the valve of FIG. 5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIGS. 1 and 2, the infusion pump 10 of the present invention is illustrated. The pump is powered by a supply of compressed gas under high pressure. The supply is carried in canister 12. The canister may be replaced as needed to insure a supply of gas capable of pumping the contents of all of the fluid sources within the pump. The gas canister 12 is connected to a pressure regulator 14. The regulator 14 accepts the high pressure from the canister 12 and produces a continuous low pressure for use in the pump. The regulator 14 has a switch 15 which may be turned on, off, or to purge. In purge, the gas supply can be emptied through a pressure relief valve 16. The preferred embodiment is an ambulatory pump. For this purpose, the canister 12 is expected to be the most convenient source of a constant pressure. In a stationary device it may be possible to replace the canister with a central line that supplies a source of gas pressure. It may also be appropriate under certain circumstances to use mechanical means of providing a continuous source of pressure.

The gas pressure acts on a compressible fluid source to urge the fluid source out of its container. According to the preferred embodiment of the present invention, a syringe 20 such as that shown in FIGS. 3 and 4 may be used as the compressible fluid source. Such a syringe is described in a copending patent application entitled "SYRINGE" invented by Eric W. Brown and sharing the same assignee and filing date as the present application. Said patent application is hereby incorporated by reference within. The pump of the present invention is illustrated with three syringes. Obviously, the pump of the present invention may be constructed with any number of sources from as low as one to as high as would be medically useful.

The described syringe 20 has an elliptical central bore 21 and an elliptical sealing member 22 which is slidable within that bore. A plunger stem 23 may be screwed into or out of the slidable member 22. To use the syringe 20 with the pump of the present invention, a conventional needle 28 is placed on the syringe tip 24 of the syringe 20. The plunger stem 23 at this time is screwed into the slidable member 22 as shown in FIG. 3. The slidable member 22 is pushed all the way against the wall of the syringe barrel and the needle 28 is poked into a desired fluid solution. The plunger stem 23 is pulled back to suck the fluid solution into the syringe 20. When the syringe contains the desired amount of solution, the plunger stem 23 is unscrewed from the slidable member and the needle is taken off the syringe tip 24. The syringe, as illustrated in FIG. 4, is now ready for use in the infusion pump. A syringe is used because it expels fluid upon being compressed. Any compressible fluid source may be used in place of the syringe. The syringe, however, is advantageously efficient in that it is capable of pushing out the entire fluid contents except for a very minor amount that might be left in the syringe tip.

The syringe tip 24 is surrounded by a luer lock fitting 26. This is a standard male luer lock fitting that holds a conventional needle on the syringe. In the pump 10, a valve 30 is placed onto the syringe tip 24 of the syringe 20. The valve 30 is illustrated in FIGS. 5, 6 and 7. The value controls the flow of fluid from its respective syringe 20. The valve 30 is normally closed to prevent fluid from escaping from the syringe 20 since the syringe is continuously under pressure while the pressure regulator 14 is on. A spring 36 within the valve 30 supplies the required pressure to hold the valve closed against the pressure exerted by the fluid from the syringe. Fluid is only allowed to leave the fluid source when the valve 30 is opened.

The valve 30 consists of a hollow housing 31. The valve 30 is made from sterilizable materials. Preferably, an inexpensive plastic material is used so that the valve is disposable. This allows total replacement of the syringes, valves and catheters with each use. By providing disposable valves the time consuming task of repeated sterilization is not required.

Tabs 32 extend from the valve housing 31 and serve as the female luer lock fitting. The tabs 32 engage the threads of the male luer lock fitting 26 so that the valve 30 may be screwed onto a syringe 20. The threads on the syringe 20 should be arranged so that the valve's outlet 44 points in the appropriate direction when the valve is screwed securely on the syringe. The valve 30 has a central bore 33 extending from an open end to a partially closed end of the housing 31. There is a ledge 39 in the central bore against which the syringe tip 24 will be held against when the valve is locked onto the syringe. At the partially closed end of the valve 30, a slot 40 provides an opening through the bottom wall of the housing 31. In construction of the valve, the spring 36 is inserted into the central bore 33. The spring 36 acts as the bias to force the valve normally closed. After the spring is inserted, a slidable sealing member 34 having a T-shaped plunger stem 38 is dropped through the central bore 33. The T-shaped stem 38 fits through the slot 40. Once it is through it may be turned 90° to help prevent it from falling back into the bore 33. The slidable member 34 provides a frictional seal against the walls of the central bore 33 to prevent fluid from leaking.

In the preferred embodiment, a flow restrictor 42 is inserted at the top of the valve 30. The flow restrictor 42 limits the flow of fluid through the valve 30 to a precise small amount. In this manner the amount of fluid solution being infused into a patient may be more accurately determined. As shown in FIG. 5, when the valve is closed the slidable member 34 is biased against the flow restrictor 42. In this position, the slidable member 34 blocks the fluid contents of the syringe from access to an outlet 44 which is provided in a side wall of the hollow housing 31. When the plunger stem 38 is retracted as in FIG. 6, fluid is allowed to flow through the flow restrictor 42, into the central bore 33 and out through the outlet 44. When the plunger stem 38 is released, the slidable sealing member pushes the fluid in the central bore out through outlet 44 and back through flow restrictor 42 until the valve is completely closed and the flow of fluid stops.

The syringe and their valves are accomodated in a pump housing 11. A rubber gasket 18 is connected to the pressure regulator 14 via conduit 17. The gasket 18 shown in FIG. 1 has three stopper-shaped seals for placement into the tops of the syringes 20. The conduit 17 may be three tubes connected together to carry the same pressure from the regulator 14. Alternatively, a single tube with three side outlet tubes may be used to connect the pressure regulator 14 to the three syringes 20. The conduit 17 is provided from the pressure regulator 14 to and through the centers of each of the stopper-shaped seals. The gasket 18 seals off each syringe 20 from the atmosphere. Each syringe 20 is subjected solely to the pressure provided from the regulator 14.

At the end of the housing opposite where the pressurized canister 12 and pressure regulator 14 are located, there are three solenoids 48. Any similarly functioning electromechanical device may be substituted for the solenoids 48. The movable core of the solenoid is provided with a clamp into which the plunger stem 38 of the valves may be snapped. When the solenoid 48 is energized the movable core is pulled downward, pulling the valve stem 38 with it to open the valve 30 and allow fluid to flow.

A catheter 52 is bonded in a conventional manner to the outlet 44 of each of the valves 30. According to the preferred embodiment, the other end of each catheter is fitted into a multilumen adapter 50. Any standard multilumen adapter may be used. The adapter connects each of the catheters 52 to a separate lumen in a multilumen catheter 53. The multilumen catheter 53 is connected to the adapter 50 for conducting fluids into the patient. It is preferred that the multilumen catheter be reinforced to prevent it from kinking. The preferred catheter set for use with the pump of the present invention is described in copending application entitled MULTILUMEN CATHETER SET sharing the same inventors, assignee and filing date as the present invention. The disclosure of said application is incorporated by reference herein. It is also possible to use separate single catheters from each of the fluid sources, however, this would require a separate intravascular access point for each tube, thereby becoming rather cumbersome and undesirable.

Each solenoid is connected to a printed circuit board 64. A control unit is provided on the circuit board 64. The control unit contains a microprocessor or other equivalent programmable controller for selectively activating the solenoids. The preferred ambulatory embodiment of the pump is provided with a flat lightweight battery package 60 which takes up a minimum amount of space and provides sufficient power to run the solenoids and the control circuitry. A shield 58 is provided to protect the electronic circuitry from any stray fluids. The shield 58 physically separates the electronic circuitry from the syringes. An interface 62 is also provided to allow the pump to interface with a programming device such as a computer or other dedicated programmer. It would also be possible but more cumbersome to provide the programming device within the pump unit itself.

In accordance with the present invention, a unique pump is provided for selectively pumping a plurality of fluid solutions into a catheter tube for infusion into a patient. It will be understood that the details of the control unit form no part of the present invention, except to the extent that it provides one commercially available programmable control means suitable for use in carrying out the steps required by the present invention, the programming techniques for adapting a microprocessor unit to such steps being well known in the microprocessor and programmable control means art.

The pump of the present invention may be programmed to provide fluids in any sequence, in any amount and at any time. The control unit is programmed to provide power to selected solenoids. The duration for which power is provided, the sequence of solenoid selection and the times at which power is provided may be programmed into the control. Pressure is continuously administered to all of the fluid sources. Fluid is infused only when a solenoid is energized to open a valve. The physician is thus given great flexibility in selecting an infusion regimen for a plurality of drug solutions.

The multilumen catheter connected to the pump may be readily attached to the patient via a Hickman apparatus. The pump may be carried by the patient for a couple of months. It is possible for a physician to regulate the administration of a drug regimen during the couple of months by programming the pump of the present invention. The patient will be provided with drug solutions at regularly prescribed intervals as preprogrammed by the physician over that period of time. The pump provides the patient with the freedom to leave his or her bed and still receive a complicated prescription involving more than one drug solution. Since electric power is only needed to periodically operate the solenoids, a small lightweight battery pack is sufficient. This contributes to the light weight of the pump which is especially beneficial to the patient's freedom of movement.

Of course, it should be understood that various changes and modifications to the preferred embodiment described above will be apparent to those skilled in the art. A switching mechanism might be placed near the pressure regulator to selectively provide pressure to selected syringes, thereby controlling delivery of fluid from the top end rather than the bottom at the valves. As already mentioned any type of compressible fluid source might be used in the present invention as well as any number of such sources. These and other changes can be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Irvine,CA,US
Assignee/Applicant First: I Flow Corporation,Irvine,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Irvine,CA,US
Assignee Count: 1
Inventor: Brown, Eric W.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W.
Inventor - w/address: Brown Eric W.,Redondo Beach,CA,US
Inventor Count: 1
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Rosenthal, Arnold
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1988-07-26
Publication Month: 07
Publication Year: 1988
Application Number: US19874621A
Application Country: US
Application Date: 1987-01-20
Application Month: 01
Application Year: 1987
Application with US Provisional: US19874621A | 1987-01-20
Priority Number: US1984677849A
Priority Country: US
Priority Date: 1984-12-05
Priority Date - Earliest: 1984-12-05
Priority Month: 12
Priority Year(s): 1984
Earliest Priority Year: 1984
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US1984677849A
1984-12-05
US4666430A
1987-05-19
Division
Granted
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M0005145
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M0005145
A
A61
A61M
A61M0005
A61M0005145
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current

A61M 5/14526


A61M 2005/14513

20130101

EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 251118, 251321, 251323, 251324
US Class (divided): 251/118, 251/321, 251/323, 251/324
US Class - Main: 251118
US Class - Original: 251118 | 251321 | 251323 | 251324
ECLA: A61M0005145B2, K61M0005145A4
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent:
Count of Cited Refs - Non-patent: 0
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US3266308A
1966-08-16
HOWARTH THOMAS R
ECLIPSE FUEL ENG CO
-
0 (Examiner)
Title: Gas meter change-over fitting
US1820951A
1931-09-01
SLICK EDWIN E
SLICK EDWIN E
-
0 (Examiner)
Title: Dispensing apparatus
US2756740A
1956-07-31
DEANE WILLIAM V
DEANE WILLIAM V
-
0 (Examiner)
Title: Drinking device for hospital patients
US3089627A
1963-05-14
ALFONS LIPPIG
ALFONS LIPPIG
-
0 (Examiner)
Title: Closure means for containers
CH378625A
1964-06-15
PAUL L GLOCKER
GLOCKER PAUL L
-
0 (Examiner)
Title: Regulierventil
US2244311A
1941-06-03
NEE RAYMOND M
NEE RAYMOND M
-
0 (Examiner)
Title: Flow restrictor
Count of Cited Refs - Patent: 6
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
DE19741249A1
1999-03-25
ITT MFG ENTERPRISES INC
DE3844306A1
1990-07-05
OPEL ADAM AG
EP1084360B1
2008-07-16
US ENVIRONMENT
EP1814611A1
2007-08-08
INTELLIJECT INC
FR2839454A1
2003-11-14
PRIMEBIOTECH
US5496287A
1996-03-05
JINOTTI; WALTER J
US5505345A
1996-04-09
ZEID; WALEED A
US6170524B1
2001-01-09
US ENVIRONMENT
US6520936B1
2003-02-18
MEDTRONIC MINIMED INC
US8105269B2
2012-01-31
ZHOU YU
US8105281B2
2012-01-31
EDWARDS ERIC SHAWN
US8137083B2
2012-03-20
ZHOU YU
US8382447B2
2013-02-26
BAXTER INT
US8496613B2
2013-07-30
ZHOU YU
US8567235B2
2013-10-29
BOJAN PETER M
WO1999061828A1
1999-12-02
US ENVIRONMENT
WO2000074751A1
2000-12-14
MEDICAL RES GROUP INC
WO2003094992A2
2003-11-20
PRIMEBIOTECH
WO2003094992A3
2004-04-01
PRIMEBIOTECH
WO2006057636A1
2006-06-01
INTELLIJECT INC
Count of Citing Patents: 20
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1992-09-29
FP
-
Description: EXPIRED DUE TO FAILURE TO PAY MAINTENANCE FEE 1992-07-26
1992-07-26
LAPS
-
Description: LAPSE FOR FAILURE TO PAY MAINTENANCE FEES
1992-02-25
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
Post-Issuance (US): EXPI Expiration 1992-07-26 1992 July 26, 1992 due to failure to pay maintenance fees.
Maintenance Status (US): E1
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
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Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4759527A
19880726
Brown Eric W.
I FLOW CORP
Title: Infusion pump valve
US4666430A
19870519
Brown Eric W.
I FLOW CORP
Title: Infusion pump
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4759527A_&format=gif&fponly=0
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Record 6/43
US4741736AProgrammable infusion pump
Publication Number: US4741736A  
Title: Programmable infusion pump
Title (Original): Programmable infusion pump
Title (English): Programmable infusion pump
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Programmable medical infusion pump has cartridge containing flexible compartments and fluid pressure roller
Abstract:


A cartridge, a control system and an infusion pump provide an infusion system. The cartridge contains one or more flexible compartments and pressure roller for squeezing fluid from the compartments. When there is a plurality of fluid compartments in the cartridge, a multilumen connector is provided on the cartridge so that it may be connected to a single multilumen catheter. The control system monitors the volume of fluid which is expelled from the fluid filled compartments during the infusion process. Any errors in rate or volume are continually fed back to the infusion pump. Errors exceeding allowable limits cause adjustment to correct for the error in volume so that over a long duration information process desired dosage is infused at an accurately maintained infusion rate. The infusion pump is provided with a constant force spring connected to a sliding member. The sliding member is pulled against the pressure roller of the cartridge to cause a fairly constant flow of fluid from the cartridge during the infusion. The pump is also provided with an optical sensing sytem for determining the position of the pressure roller and thereby the volume of fluid which is being infused. The cartridge has a position indicating strip for use with the optical sensing system in order to provide the position information.
Abstract (English):

A cartridge, a control system and an infusion pump provide an infusion system. The cartridge contains one or more flexible compartments and pressure roller for squeezing fluid from the compartments. When there is a plurality of fluid compartments in the cartridge, a multilumen connector is provided on the cartridge so that it may be connected to a single multilumen catheter. The control system monitors the volume of fluid which is expelled from the fluid filled compartments during the infusion process. Any errors in rate or volume are continually fed back to the infusion pump. Errors exceeding allowable limits cause adjustment to correct for the error in volume so that over a long duration information process desired dosage is infused at an accurately maintained infusion rate. The infusion pump is provided with a constant force spring connected to a sliding member. The sliding member is pulled against the pressure roller of the cartridge to cause a fairly constant flow of fluid from the cartridge during the infusion. The pump is also provided with an optical sensing sytem for determining the position of the pressure roller and thereby the volume of fluid which is being infused. The cartridge has a position indicating strip for use with the optical sensing system in order to provide the position information.
Abstract (French):
Abstract (German):
Abstract (Original):

A cartridge, a control system and an infusion pump provide an infusion system. The cartridge contains one or more flexible compartments and pressure roller for squeezing fluid from the compartments. When there is a plurality of fluid compartments in the cartridge, a multilumen connector is provided on the cartridge so that it may be connected to a single multilumen catheter. The control system monitors the volume of fluid which is expelled from the fluid filled compartments during the infusion process. Any errors in rate or volume are continually fed back to the infusion pump. Errors exceeding allowable limits cause adjustment to correct for the error in volume so that over a long duration information process desired dosage is infused at an accurately maintained infusion rate. The infusion pump is provided with a constant force spring connected to a sliding member. The sliding member is pulled against the pressure roller of the cartridge to cause a fairly constant flow of fluid from the cartridge during the infusion. The pump is also provided with an optical sensing sytem for determining the position of the pressure roller and thereby the volume of fluid which is being infused. The cartridge has a position indicating strip for use with the optical sensing system in order to provide the position information.
Abstract (Spanish):
Claims:

I claim:
1. A multiple fluid cartridge assembly comprising: *
a housing; *
a plurality of flexible compartments for containing fluids, each compartment having an outlet through which said fluids are expelled; *
a pressure roller movable within said housing to compress said plurality of flexible compartments, said pressure roller including engagement means extending from said housing; *
a plurality of access tubes, each tube connected to the outlet of one of said compartment; *
a multiple port connector, each port being connected to one of said access tubes; and *
flow restrictor means for adjustably compressing said plurality of access tubes to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
2. The multiple fluid cartridge of claim 1 further comprising gear means extending from said housing and connected to said flow restrictor means for adjusting the pressure exerted by said flow restrictor means on said plurality of access tubes.
3. The multiple fluid cartridge of claim 1 further comprising a strip having position indicating markings along its length, said strip being arranged on said housing with its length in the direction of movement of said pressure roller.
4. The multiple cartridge of claim 1 further comprising a resilient base within said housing beneath said plurality of compartments and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
5. The multiple cartridge of claim 4 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
6. A fluid dispensing cartridge assembly comprising: *
a housing; *
at least one flexible compartment for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a pressure roller movable within said housing to compress said at least one flexible compartment, said pressure roller including means extending from said housing for engagement with a drive mechanism; *
position indicating markings arranged along the length of said housing in the direction of movement of said pressure roller; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so the rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
7. The fluid dispensing cartridge of claim 6 wherein said position indicating markings are provided on a reflective strip on said housing.
8. The fluid dispensing cartridge of claim 6 further comprising gear means extending from said housing and connected to said flow restrictor means to control the adjustment of the pressure exerted by said flow restrictor means on said plurality of access tubes.
9. The fluid dispensing cartridge of claim 6 further comprising a resilient base within said housing beneath said at least one compartment and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
10. The fluid dispensing cartridge of claim 9 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
11. A fluid dispensing cartridge assembly comprising: *
a housing having a resilient base; *
at least one flexible compartment formed on said resilient base for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a roller for compressing said at least one compartment against said resilient base to squeeze fluid out through the outlets of said at least one compartment; *
means for holding said roller against said base to prevent fluid from leaking within any of said at least one compartments between said roller and said base; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
12. The fluid dispensing cartridge of claim 11 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
13. The fluid dispensing cartridge of claim 11 further comprising gear means extending from said housing and connected to said flow restrictor means to control the adjustment of the pressure exerted by said flow restrictor means on said plurality of access tubes.
14. The fluid dispensing cartridge of claim 11 further comprising a strip having position indicating markings along its length, said strip being arranged on said housing with its length in the direction of movement of said pressure roller.
15. A programmable pump comprising: *
a housing; *
a sliding member within said housing; *
means for applying a substantially constant force to said slidable member; *
means for detecting the position of said slidable member within said housing; *
a motor; *
means, coupled to said motor, for regulating a flow restrictor; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that said slidable member moves through said housing to provide a preprogrammed volume of flow per the time duration of the infusion.
16. The programmable pump of claim 15 wherein said position detecting means comprises an optical emitter and detector carried by said slidable member.
17. The programmable pump of claim 16 wherein said position detecting means further comprises a strip having position indicating markings along its length, said strip being arranged in said housing with its length in the direction of movement of said slidable member and said optical emitter and detector interact with said strip to read the markings thereon as said slidable member moves relative thereto.
18. The programmable pump of claim 15 wherein said means for applying a substantially constant force comprises a constant force spring.
19. The programmable pump of claim 18 wherein said constant force spring comprises a coil prevented from translational movement within said housing having one end connected to said slidable member.
20. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
means for applying pressure coupled to the free end of said constant force spring such that said pressure applying means is pulled against said at least one compartment for pushing fluid therefrom; and *
flow restrictor means for regulating the flow of fluid out of said at least one compartment; *
a motor on said pump housing; and *
gear means connected to said motor for adjusting said flow restrictor means.
21. The infusion pump of claim 20 wherein said pressure applying means comprises a slidable member connected to the free end of said constant force spring and a roller engaged by said slidable member so that said roller is pulled against said at least one compartment for squeezing fluid therefrom.
22. The infusion pump of claim 21 wherein said fluid containing compartment is a flexible compartment formed on a resilient base and said roller is held against said base to prevent fluid from leaking within said compartment between said roller and said resilient base.
23. The infusion pump of claim 20 further comprising: *
a strip having position indicating markings along its length, said strip being arranged with its length in the direction of movement of said pressure applying means; and *
an optical emitter and detector carried by said pressure applying means to read the position of said pressure applying means relative to said at least one compartment as said pressure applying means is pulled against said at least one compartment.
24. The infusion pump of claim 23 further comprising programmable controller means responsive to said emitter and detector for controlling said motor to set said flow restrictor means so that fluid is pushed from said at least one compartment at a predetermined rate.
25. The infusion pump of claim 21 wherein said at least one fluid containing compartment is located on a cartridge insertable into said pump housing.
26. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment located on a cartridge insertable into said pump housing; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said constant force spring; and *
a roller engaged by said slidable member so that said roller is pulled against said at least one compartment for squeezing fluid therefrom, wherein said roller includes an engagement means extending through slots of said cartridge for engaging said slidable member such that when said cartridge is loaded into said pump housing said engagement means engages said slidable member to unwind said constant force spring.
27. A programmable infusion pump comprising: *
a pump housing for receiving a cartridge housing, said cartridge housing containing at least one flexible fluid containing compartment each compartment having an access tube through which fluid can be expelled; *
a substantially constant force spring having a free end on the exterior of a coil, said coil mounted within said pump housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said spring; *
a roller carried in said cartridge housing and engaged by said slidable member for compressing said at least one compartment to squeeze fluid out through the access tubes of said at least one compartment; *
flow restrictor means for restricting the flow of fluid out through the access tubes; *
a motor coupled to said flow restrictor means for regulating said flow restrictor means; *
means for detecting the position of said roller; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that as said roller is pulled through said cartridge housing by said slidable member, a preprogrammed volume of fluid flows out of said at least one flexible compartment per time duration of the infusion.
28. The programmable infusion pump of claim 27 further comprising a strip having position indicating markings along its length, said strip being arranged on said cartridge housing with its length in the direction of movement of said roller.
29. The programmable infusion pump of claim 28 wherein said position detecting means comprises an optical emitter and detector carried by said slidable member to read the position of said slidable member relative to said at least one compartment as said roller is pulled across said at least one compartment, the position of said slidable member being directly related to the position of said pressure roller.
30. The programmable infusion pump of claim 27 wherein said flow restrictor means includes: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hold engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
31. The programmable infusion pump of claim 27 further comprising a multiple port connector, each port being connected to one of said access tubes.
32. The programmable infusion pump of claim 27 wherein said cartridge housing further comprises a resilient base within said housing beneath said at least one compartment and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
33. A method for maintaining a predetermined infusion rate comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a movable member for pushing fluid out of said compartment; *
counting the amount of time for which said infusion apparatus is being used during the infusion; *
determining the time it takes said movable member to move from a first position to a second position; *
determining the volume of fluid infused between the first position and the second position; *
dividing the volume of fluid infused between the first position and the second position by the amount of time it took to move from the first position to the second position to determine the current infusion rate; *
comparing the current infusion rate with the predetermined infusion rate; and *
adjusting the rate of fluid flow from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when said current infusion rate differs from said predetermined infusion rate by more than a predetermined tolerance.
34. The method of claim 33 further comprising locating the position of said movable member by emitting a ray of light at a strip of position indicating markings, receiving any light reflected from said position indicating markings and interpreting the received light to determine the position of said movable member.
35. A method of infusing a predetermined volume of fluid over a predetermined infusion time period comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a means for expelling fluid from said compartment; *
counting the time as said infusion apparatus is used during an infusion; *
determining the time it takes to infuse a sample volume of fluid, said sample volume being smaller than said predetermined volume; *
dividing the sample volume by the amount of time it took to infuse said sample volume to determine the current infusion rate; *
determining a rate error as a function of the current infusion rate and a desired rate which will result in the infusion of the predetermined volume of fluid at the end of the predetermined infusion time period; *
determining the total volume of fluid infused between the start of the infusion and the end of the infusion of said sample volume; *
determining a volumetric error as a function of the total volume of fluid infused and a desired volume which is the product of the predetermined volume of fluid and the rate of the time elapsed between the start of infusion and the end of the infusion of said sample volume to the predetermined infusion time period; and *
adjusting the flow of fluid from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when either said rate error exceeds a predetermined rate tolerance or said volumetric error exceeds a predetermined volume tolerance.
36. The method of claim 35 further comprising the step of detecting the position of movable member, said movable member being used to push fluid out of said compartment and wherein the volume of infused fluid is determined as a function of the position of said movable member.
37. The method of claim 36 wherein the step of detecting position comprises emitting a ray of light at a strip of position indicating markings, receiving any light reflected from said position indicating markings and interpreting the received light to determine the position of said movable member.
Claims Count: 37
Claims (English):

I claim:
1. A multiple fluid cartridge assembly comprising: *
a housing; *
a plurality of flexible compartments for containing fluids, each compartment having an outlet through which said fluids are expelled; *
a pressure roller movable within said housing to compress said plurality of flexible compartments, said pressure roller including engagement means extending from said housing; *
a plurality of access tubes, each tube connected to the outlet of one of said compartment; *
a multiple port connector, each port being connected to one of said access tubes; and *
flow restrictor means for adjustably compressing said plurality of access tubes to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
2. The multiple fluid cartridge of claim 1 further comprising gear means extending from said housing and connected to said flow restrictor means for adjusting the pressure exerted by said flow restrictor means on said plurality of access tubes.
3. The multiple fluid cartridge of claim 1 further comprising a strip having position indicating markings along its length, said strip being arranged on said housing with its length in the direction of movement of said pressure roller.
4. The multiple cartridge of claim 1 further comprising a resilient base within said housing beneath said plurality of compartments and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
5. The multiple cartridge of claim 4 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
6. A fluid dispensing cartridge assembly comprising: *
a housing; *
at least one flexible compartment for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a pressure roller movable within said housing to compress said at least one flexible compartment, said pressure roller including means extending from said housing for engagement with a drive mechanism; *
position indicating markings arranged along the length of said housing in the direction of movement of said pressure roller; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so the rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
7. The fluid dispensing cartridge of claim 6 wherein said position indicating markings are provided on a reflective strip on said housing.
8. The fluid dispensing cartridge of claim 6 further comprising gear means extending from said housing and connected to said flow restrictor means to control the adjustment of the pressure exerted by said flow restrictor means on said plurality of access tubes.
9. The fluid dispensing cartridge of claim 6 further comprising a resilient base within said housing beneath said at least one compartment and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
10. The fluid dispensing cartridge of claim 9 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
11. A fluid dispensing cartridge assembly comprising: *
a housing having a resilient base; *
at least one flexible compartment formed on said resilient base for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a roller for compressing said at least one compartment against said resilient base to squeeze fluid out through the outlets of said at least one compartment; *
means for holding said roller against said base to prevent fluid from leaking within any of said at least one compartments between said roller and said base; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
12. The fluid dispensing cartridge of claim 11 wherein said means for holding said roller comprises a pair of slots in opposite sides of said housing.
13. The fluid dispensing cartridge of claim 11 further comprising gear means extending from said housing and connected to said flow restrictor means to control the adjustment of the pressure exerted by said flow restrictor means on said plurality of access tubes.
14. The fluid dispensing cartridge of claim 11 further comprising a strip having position indicating markings along its length, said strip being arranged on said housing with its length in the direction of movement of said pressure roller.
15. A programmable pump comprising: *
a housing; *
a sliding member within said housing; *
means for applying a substantially constant force to said slidable member; *
means for detecting the position of said slidable member within said housing; *
a motor; *
means, coupled to said motor, for regulating a flow restrictor; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that said slidable member moves through said housing to provide a preprogrammed volume of flow per the time duration of the infusion.
16. The programmable pump of claim 15 wherein said position detecting means comprises an optical emitter and detector carried by said slidable member.
17. The programmable pump of claim 16 wherein said position detecting means further comprises a strip having position indicating markings along its length, said strip being arranged in said housing with its length in the direction of movement of said slidable member and said optical emitter and detector interact with said strip to read the markings thereon as said slidable member moves relative thereto.
18. The programmable pump of claim 15 wherein said means for applying a substantially constant force comprises a constant force spring.
19. The programmable pump of claim 18 wherein said constant force spring comprises a coil prevented from translational movement within said housing having one end connected to said slidable member.
20. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
means for applying pressure coupled to the free end of said constant force spring such that said pressure applying means is pulled against said at least one compartment for pushing fluid therefrom; and *
flow restrictor means for regulating the flow of fluid out of said at least one compartment; *
a motor on said pump housing; and *
gear means connected to said motor for adjusting said flow restrictor means.
21. The infusion pump of claim 20 wherein said pressure applying means comprises a slidable member connected to the free end of said constant force spring and a roller engaged by said slidable member so that said roller is pulled against said at least one compartment for squeezing fluid therefrom.
22. The infusion pump of claim 21 wherein said fluid containing compartment is a flexible compartment formed on a resilient base and said roller is held against said base to prevent fluid from leaking within said compartment between said roller and said resilient base.
23. The infusion pump of claim 20 further comprising: *
a strip having position indicating markings along its length, said strip being arranged with its length in the direction of movement of said pressure applying means; and *
an optical emitter and detector carried by said pressure applying means to read the position of said pressure applying means relative to said at least one compartment as said pressure applying means is pulled against said at least one compartment.
24. The infusion pump of claim 23 further comprising programmable controller means responsive to said emitter and detector for controlling said motor to set said flow restrictor means so that fluid is pushed from said at least one compartment at a predetermined rate.
25. The infusion pump of claim 21 wherein said at least one fluid containing compartment is located on a cartridge insertable into said pump housing.
26. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment located on a cartridge insertable into said pump housing; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said constant force spring; and *
a roller engaged by said slidable member so that said roller is pulled against said at least one compartment for squeezing fluid therefrom, wherein said roller includes an engagement means extending through slots of said cartridge for engaging said slidable member such that when said cartridge is loaded into said pump housing said engagement means engages said slidable member to unwind said constant force spring.
27. A programmable infusion pump comprising: *
a pump housing for receiving a cartridge housing, said cartridge housing containing at least one flexible fluid containing compartment each compartment having an access tube through which fluid can be expelled; *
a substantially constant force spring having a free end on the exterior of a coil, said coil mounted within said pump housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said spring; *
a roller carried in said cartridge housing and engaged by said slidable member for compressing said at least one compartment to squeeze fluid out through the access tubes of said at least one compartment; *
flow restrictor means for restricting the flow of fluid out through the access tubes; *
a motor coupled to said flow restrictor means for regulating said flow restrictor means; *
means for detecting the position of said roller; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that as said roller is pulled through said cartridge housing by said slidable member, a preprogrammed volume of fluid flows out of said at least one flexible compartment per time duration of the infusion.
28. The programmable infusion pump of claim 27 further comprising a strip having position indicating markings along its length, said strip being arranged on said cartridge housing with its length in the direction of movement of said roller.
29. The programmable infusion pump of claim 28 wherein said position detecting means comprises an optical emitter and detector carried by said slidable member to read the position of said slidable member relative to said at least one compartment as said roller is pulled across said at least one compartment, the position of said slidable member being directly related to the position of said pressure roller.
30. The programmable infusion pump of claim 27 wherein said flow restrictor means includes: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hold engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
31. The programmable infusion pump of claim 27 further comprising a multiple port connector, each port being connected to one of said access tubes.
32. The programmable infusion pump of claim 27 wherein said cartridge housing further comprises a resilient base within said housing beneath said at least one compartment and means for holding said roller against said base to prevent fluid from leaking within any of said compartments between said roller and said base.
33. A method for maintaining a predetermined infusion rate comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a movable member for pushing fluid out of said compartment; *
counting the amount of time for which said infusion apparatus is being used during the infusion; *
determining the time it takes said movable member to move from a first position to a second position; *
determining the volume of fluid infused between the first position and the second position; *
dividing the volume of fluid infused between the first position and the second position by the amount of time it took to move from the first position to the second position to determine the current infusion rate; *
comparing the current infusion rate with the predetermined infusion rate; and *
adjusting the rate of fluid flow from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when said current infusion rate differs from said predetermined infusion rate by more than a predetermined tolerance.
34. The method of claim 33 further comprising locating the position of said movable member by emitting a ray of light at a strip of position indicating markings, receiving any light reflected from said position indicating markings and interpreting the received light to determine the position of said movable member.
35. A method of infusing a predetermined volume of fluid over a predetermined infusion time period comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a means for expelling fluid from said compartment; *
counting the time as said infusion apparatus is used during an infusion; *
determining the time it takes to infuse a sample volume of fluid, said sample volume being smaller than said predetermined volume; *
dividing the sample volume by the amount of time it took to infuse said sample volume to determine the current infusion rate; *
determining a rate error as a function of the current infusion rate and a desired rate which will result in the infusion of the predetermined volume of fluid at the end of the predetermined infusion time period; *
determining the total volume of fluid infused between the start of the infusion and the end of the infusion of said sample volume; *
determining a volumetric error as a function of the total volume of fluid infused and a desired volume which is the product of the predetermined volume of fluid and the rate of the time elapsed between the start of infusion and the end of the infusion of said sample volume to the predetermined infusion time period; and *
adjusting the flow of fluid from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when either said rate error exceeds a predetermined rate tolerance or said volumetric error exceeds a predetermined volume tolerance.
36. The method of claim 35 further comprising the step of detecting the position of movable member, said movable member being used to push fluid out of said compartment and wherein the volume of infused fluid is determined as a function of the position of said movable member.
37. The method of claim 36 wherein the step of detecting position comprises emitting a ray of light at a strip of position indicating markings, receiving any light reflected from said position indicating markings and interpreting the received light to determine the position of said movable member.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A multiple fluid cartridge assembly comprising: *
a housing; *
a plurality of flexible compartments for containing fluids, each compartment having an outlet through which said fluids are expelled; *
a pressure roller movable within said housing to compress said plurality of flexible compartments, said pressure roller including engagement means extending from said housing; *
a plurality of access tubes, each tube connected to the outlet of one of said compartment; *
a multiple port connector, each port being connected to one of said access tubes; and *
flow restrictor means for adjustably compressing said plurality of access tubes to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
Independent Claims:
1. A multiple fluid cartridge assembly comprising: *
a housing; *
a plurality of flexible compartments for containing fluids, each compartment having an outlet through which said fluids are expelled; *
a pressure roller movable within said housing to compress said plurality of flexible compartments, said pressure roller including engagement means extending from said housing; *
a plurality of access tubes, each tube connected to the outlet of one of said compartment; *
a multiple port connector, each port being connected to one of said access tubes; and *
flow restrictor means for adjustably compressing said plurality of access tubes to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against said access tubes; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
6. A fluid dispensing cartridge assembly comprising: *
a housing; *
at least one flexible compartment for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a pressure roller movable within said housing to compress said at least one flexible compartment, said pressure roller including means extending from said housing for engagement with a drive mechanism; *
position indicating markings arranged along the length of said housing in the direction of movement of said pressure roller; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so the rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
11. A fluid dispensing cartridge assembly comprising: *
a housing having a resilient base; *
at least one flexible compartment formed on said resilient base for containing fluid, each compartment being connected by an access tube to an outlet for expelling fluid; *
a roller for compressing said at least one compartment against said resilient base to squeeze fluid out through the outlets of said at least one compartment; *
means for holding said roller against said base to prevent fluid from leaking within any of said at least one compartments between said roller and said base; and *
flow restrictor means for adjustably compressing each said access tube to regulate the flow of fluid therethrough, said flow restrictor means including: *
a compression member for contacting and pressing against each said access tube; *
a spring located adjacent said compression member so that said spring may exert force against said compression member; *
a rotatable threaded cylindrical member; and *
a non-rotating member having a threaded hole engaged by said cylindrical member, said non-rotating member being adjacent said spring opposite said compression member so that rotation of said cylindrical member adjusts the force exerted by said non-rotating member on said spring and consequently adjusting the force exerted by said spring on said compression member.
15. A programmable pump comprising: *
a housing; *
a sliding member within said housing; *
means for applying a substantially constant force to said slidable member; *
means for detecting the position of said slidable member within said housing; *
a motor; *
means, coupled to said motor, for regulating a flow restrictor; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that said slidable member moves through said housing to provide a preprogrammed volume of flow per the time duration of the infusion.
20. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
means for applying pressure coupled to the free end of said constant force spring such that said pressure applying means is pulled against said at least one compartment for pushing fluid therefrom; and *
flow restrictor means for regulating the flow of fluid out of said at least one compartment; *
a motor on said pump housing; and *
gear means connected to said motor for adjusting said flow restrictor means.
26. An infusion pump comprising: *
a pump housing for receiving at least one fluid containing compartment located on a cartridge insertable into said pump housing; *
a constant force spring having a free end at the exterior of a coil, said coil mounted within said housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said constant force spring; and *
a roller engaged by said slidable member so that said roller is pulled against said at least one compartment for squeezing fluid therefrom, wherein said roller includes an engagement means extending through slots of said cartridge for engaging said slidable member such that when said cartridge is loaded into said pump housing said engagement means engages said slidable member to unwind said constant force spring.
27. A programmable infusion pump comprising: *
a pump housing for receiving a cartridge housing, said cartridge housing containing at least one flexible fluid containing compartment each compartment having an access tube through which fluid can be expelled; *
a substantially constant force spring having a free end on the exterior of a coil, said coil mounted within said pump housing so as to be prevented from translational movement; *
a slidable member connected to the free end of said spring; *
a roller carried in said cartridge housing and engaged by said slidable member for compressing said at least one compartment to squeeze fluid out through the access tubes of said at least one compartment; *
flow restrictor means for restricting the flow of fluid out through the access tubes; *
a motor coupled to said flow restrictor means for regulating said flow restrictor means; *
means for detecting the position of said roller; and *
programmable controller means responsive to said position detecting means for operating said motor to regulate the flow restrictor such that as said roller is pulled through said cartridge housing by said slidable member, a preprogrammed volume of fluid flows out of said at least one flexible compartment per time duration of the infusion.
33. A method for maintaining a predetermined infusion rate comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a movable member for pushing fluid out of said compartment; *
counting the amount of time for which said infusion apparatus is being used during the infusion; *
determining the time it takes said movable member to move from a first position to a second position; *
determining the volume of fluid infused between the first position and the second position; *
dividing the volume of fluid infused between the first position and the second position by the amount of time it took to move from the first position to the second position to determine the current infusion rate; *
comparing the current infusion rate with the predetermined infusion rate; and *
adjusting the rate of fluid flow from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when said current infusion rate differs from said predetermined infusion rate by more than a predetermined tolerance.
35. A method of infusing a predetermined volume of fluid over a predetermined infusion time period comprising the steps of: *
providing infusion apparatus having a fluid containing compartment and a means for expelling fluid from said compartment; *
counting the time as said infusion apparatus is used during an infusion; *
determining the time it takes to infuse a sample volume of fluid, said sample volume being smaller than said predetermined volume; *
dividing the sample volume by the amount of time it took to infuse said sample volume to determine the current infusion rate; *
determining a rate error as a function of the current infusion rate and a desired rate which will result in the infusion of the predetermined volume of fluid at the end of the predetermined infusion time period; *
determining the total volume of fluid infused between the start of the infusion and the end of the infusion of said sample volume; *
determining a volumetric error as a function of the total volume of fluid infused and a desired volume which is the product of the predetermined volume of fluid and the rate of the time elapsed between the start of infusion and the end of the infusion of said sample volume to the predetermined infusion time period; and *
adjusting the flow of fluid from said infusion apparatus by adjusting a flow restrictor means to vary the size of an outlet from said compartment when either said rate error exceeds a predetermined rate tolerance or said volumetric error exceeds a predetermined volume tolerance.
Description:

BACKGROUND OF THE INVENTION

This invention relates to a method and apparatus for infusing fluids accurately in terms of dosages or infusion rates. In particular it relates to a programmable infusion pump that receives a multiple fluid cartridge.

Infusion pumps are used to administer a variety of drug therapies to patients. Examples of two such diverse applications are the administration of chemotherapy drugs to cancer patients and the administration of heart-rate control drugs to cardiac patients.

The patient receiving drugs which are used to control his heart rate needs to have the fluid delivered at an extremely constant rate because the rate of his heartbeat is proportional (or inversely proportional, as the case may be) to the amount of drug delivered. If the rate of infusion were to decrease or increase significantly, the heart would pump more slowly or more quickly than desired. It is important for the infusion pump administering these drugs to return as quickly as possible to the proper infusion rate.

The volume of a heart rate control drug which was overinfused or underinfused does not have to be corrected for. If, for example, a volumetric correction was made to infuse an additional bolus of drug because the pump had slowed down, the patient might find his heart beating overly fast for a period of time. This would be highly undesirable and might even be dangerous for the patient. This type of therapy is referred to herein as a rate-dependent therapy, and many other examples of such therapies exist.

Another type of therapy which requires an infusion pump is the administration of chemotherapy drugs to cancer patients. A recent trend in the administration of chemotherapy is to provide for a slow, continuous infusion in place of the tradition bolus injection of a cytotoxin. It has been found by many cancer researchers and oncologists that the severe side-effects of chemotherapy, such as nausea, vomiting, diarrhea, anorexia, and lassitude, may be reduced in a significant number of patients if the drugs are administered in lower dosages over a prolonged period of time.

As an example relating to infusion pumps, the dosage of certain cytotoxins which may be administered is determined by approximating the surface area of the skin of the patient. The number of milligrams of drug to be administered for each square meter of skin per day for a given therapy is then computed. This amount of drug may then be administered by the traditional bolus injection in a few seconds or by the more advantageous continuous infusion method over a period of hours or even days.

When the more advantageous continuous infusion method is used, it becomes apparent that the infusion device must endeavor to administer the required volume (i.e., number of prescribed milligrams) of drug for a period of days. This type of therapy is referred to herein as a dosage-dependent therapy or volume-dependent therapy.

For an infusion device to perform this dosage-dependent therapy accurately, it must maintain a fairly constant infusion rate and determine if any undesired fluctuations in rate occurred. There must be a correction for the amount of drug which was underinfused or overinfused during a period of fluctuation.

For example, if the device were infusing the cytotoxins to the cancer patient too slowly for a period of time, it must determine how many milligrams of drug were not infused and it must then correct for the deficiency by infusing an additional amount of drug for a period of time. After the correction has been made, the pump must endeavor to return to the desired rate so that the prescribed amount of the remaining drug is administered to the patient in the required time period.

The small volumetric errors caused by the mechanism of conventional infusion pumps, as illustrated in the cardiac patient example, are not advantageous in the drug therapy of a cancer patient because they can build up to substantial cumulative errors over a long period of time. This is especially true when the pump is being used in an ambulatory patient who is not subject to continuous surveilance.

It is an object of the method of the present invention to provide physicians with the means for properly administering dosage-dependent therapies.

In recent times it has become increasingly desirable to provide an infusion pump which is compact and lightweight so that it may be used by an ambulatory patient. Ambulatory infusion pumps reduce the need for excess use of hospital facilities and resources. In order to provide a lightweight pump it is highly desirable that a pump require a minimal amount of electric power since power sources, such as batteries, can contribute substantially to the weight of a pump.

It is another object of this invention to provide for a compact, lightweight infusion pump which may be used by ambulatory patients.

There are also an increasing number of applications for which there is a need for a pump which can intravenously administer a plurality of drugs solutions. One such application is the use of chemotherapy to treat such diseases as cancer. Many of the drugs used in chemotherapy and other therapies cannot be mixed together prior to an infusion. Some of these drugs react to neutralize one another. Other drugs react to form precipitates which may block the catheter tube or possibly cause an embolism in the patient.

It is often found that when different incompatible drug solutions are used on a single patient, they are administered by using a separate catheter tube for each drug. A separate infusion pump would then be used on each individual catheter tube line and the tube would deliver the fluid solution into the patient through its respective intravascular access needle. Since a patient must pay for each catheter set and must rent a pump for use with each catheter tube, it becomes costly to use multiple catheter tubes and pumps. There is some danger of infection any time an opening is made in a patient's skin for a catheter. The likelihood of infection increases as more openings are made to accommodate multiple lines.

It is therefore yet another object of this invention to provide a single pump, with a single vascular-entry catheter set, that can deliver a multiplicity of drug solutions without mixing any of them prior to infusion. It is still yet another object of this invention to provide an ambulatory infusion pump which can administer several different drug solutions without mixing any of the fluids together.

SUMMARY OF THE INVENTION

The infusion pump of the present invention is achieved by using a unique multiple fluid cartridge assembly. The cartridge houses a plurality of flexible compartments and a pressure roller which rolls over the compartments to squeeze fluid out through their outlet opening. A plurality of access tubes connect to the openings in the flexible compartments and a multiple port connector is provided so that a single multilumen catheter can be easily connected to the cartridge for use in the infusion process. The cartridge is advantageously constructed with a resilient base to better insure that fluid does not leak behind the roller when it presses against the fluid compartments.

The cartridge may be advantageously provided with position markings along the length of the housing. These markings can be used to monitor the position of the pressure roller during the infusion process. The pump of the present invention includes an optical sensor which can read from the position markings to give a determination of where the pressure roller is. The pump is provided with a microprocessor type controller which can calculate the rate at which fluid is being delivered from the pump as a function of the time it has taken the roller to travel a measured distance. The pump of the present invention is advantageously powered by a constant force spring. Thus, the power is provided mechanically when the cartridge is inserted into the pump. There is no need for electrical power to push fluid out of the pump. A motor is provided however which controls a flow restriction valve. If the microprocessor determines that the pump is not operating at the predetermined rate, the position of the valve is changed to increase or decrease the rate of infusion. It requires very little power to occasionally operate the valve during an infusion process.

The cartridge pump of the present invention advantageously employs a novel method for maintaining highly accurate infusion rates. The optical emitter and sensor monitor the position of the pressure roller by reading the position markings. The location is fed into the programmable controller. The distance travelled from the beginning of the infusion is used in determining the total volume of the fluid which has been infused. The amount of fluid which is delivered per distance travelled by the roller is already known by the controller. The controller also determines the current rate of infusion by taking the volume of fluid infused in a predetermined distance and dividing it by the time it took the pressure roller to progress that distance. Thus the current rate and the total volume can be compared to the predetermined rate and volume. The comparison can be accomplished repetitively throughout the infusion process. By making a correction whenever the rate error or volume error exceeds a threshold value an accurate infusion rate can be maintained throughout the infusion process. This method is thus highly advantageous for use in dosage dependent and rate dependent therapies.

Other objects and advantages of the present invention will become apparent during the following description of the presently preferred embodiment of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a multilumen infusion system using the pump and cartridge of the present invention.

FIG. 2 is a perspective view with portions cut away of the cartridge of the present invention.

FIG. 3 is an exploded view of the base portion of the cartridge housing of FIG. 2.

FIG. 4A is a cross-sectional view of the flow restrictor valve of FIG. 2 in an open position.

FIG. 4B is a cross-sectional view of the flow restrictor valve of FIG. 2 in the fully closed position.

FIG. 5 is a magnified view of a portion of the position indicating strip of the present invention.

FIG. 6 is an illustration of a cartridge of FIG. 2 in the process of being filled with fluid.

FIG. 7 is a perspective view partially cut away of the pump of the present invention.

FIG. 8 is a side view in cross-section of the pump of FIG. 7.

FIG. 9 is an end view in cross-section of the pump of FIG. 7.

FIG. 10 provides an enlarged view of the optical sensing mechanism of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to FIG. 1, the various pieces of a multilumen infusion system using the present invention are shown. The present invention includes a constant pressure infusion pump 10 which receives a multiple drug cartridge 20. The pump 10 of the preferred embodiment is powered by a constant force spring. A position indicating strip 22 is located on the multiple drug cartridge 20 for use by the pump 10 in monitoring the rate of infusion. The total volume of drug to be infused and the desired length of time for the infusion is programmed into the pump by a detachable programming unit 30.

The multiple drug cartridge 20 includes a multiple port connector 24. The multiple port connector 24 provides an outlet for each of the fluids being pumped from the cartridge 20. The multiple port connector 24 is adapted for connection to a connector 32 on a multilumen catheter 34. In the embodiment shown, the multiple port connector 24 and connector 32 snap-fit together. Of course, other multilumen connectors could be substituted for the snap-fit connectors. For example, at the other end of multilumen catheter 34 is a multilumen catheter connector with a threaded locking ring. Such a multilumen locking connector is disclosed in U.S. Pat. No. 4,581,012, issued Apr. 8, 1986, the disclosure of which is incorporated by reference herein. The multilumen locking connector is used to connect multilumen catheter 34 to an implantable multilumen catheter 40. The implantable multilumen catheter includes a tissue cuff 42 for forming a seal with the skin of a patient.

The multilumen infusion system of FIG. 1 provides for a simple and controlled infusion of a plurality of fluid solutions into a patient. Although the invention as described herein derives significant advantages from providing a plurality of fluid solutions through a multiple lumen catheter set, the infusion pump and cartridge of the present invention may also be made for use with a single fluid cartridge and conventional single lumen catheter.

Referring now to FIGS. 2 and 3, the multiple drug cartridge 20 of the present invention is shown in greater detail. The cartridge 20 is contained by a housing 21 which carries a plurality of flexible fluid containing compartments 36. Each compartment 36 has an outlet 37 connected to an access tube 38. A pressure roller 28 is provided inside the cartridge for rolling over the flexible compartments 36 in order to squeeze fluid out through the access tubes 38. The access tubes 38 extend into the multiple port connector 24. The pressure roller 28 includes a knob 29 on either side which extends from the cartridge for engaging a drive mechanism in the pump 10. The drive mechanism of the present invention is a sliding member pulled by a constant force spring. In accordance with the presently preferred embodiment, the knobs 29 extend from both ends of the pressure roller and ride within a pair of slots or tracks 31. It may also be possible to provide an open faced cartridge for use in a pump which already contains a pressure roller. However, the presently preferred arrangement is to include the roller 28 within the cartridge.

In order to control the rate of infusion of fluids from the cartridge 20, a flow restrictor valve 50 is provided for interaction with the access tubes 38. The valve 50 is controlled by an external gear 26 which is engageable with a mating gear inside the pump 10. Turning the gear 26 will change the pressure exerted upon the access tubes 38 by the valve 50. The more pressure which is applied by the valve 50 to the access tubes 38 the more restricted the flow of fluids therethrough. The valve 50 can be wound entirely down against the access tubes to completely close off fluid flow when desired.

The bottom of the cartridge housing 21 is a solid base member 44. Overlaying the solid base member 44 is a resilient layer 46. The resilient layer 46 is compressible by the pressure roller 28. Thus, as the pressure roller 28 is moved along the slots 31 through the cartridge a tight seal is formed between the roller 28 and the resilient layer 46 to prevent fluid from escaping behind the roller within a flexible compartment 36. All fluid is forced out through the access tubes 38. It is the resiliency of the layer 36 which causes it to push up against the roller 28 as the roller is held within the slots 31 down against the layer 46 thus forming the tight seal. The flexible compartments 36 are formed on the resilient layer 46 by a plastic molded layer 48. Layer 48 is molded in the shape of a plurality of compartments with an access tube 38 leading from each compartment. It would of course be possible to practice the invention using flexible bags to contain fluids instead of the multilayer construction described herein. In the presently preferred embodiment, both layer 46 and layer 48 are made of silicone, such as Dow Corning Silastic.

The relative infusion rate of the fluids in the compartments is determined by the geometry of the compartment. When the compartments are all the same size then the fluids in each are infused at the same rate. It is preferable that each compartment has the same length but varies in width or height to provide a different volume compartment. With all compartments the same length those with a larger width and/or height will have a larger volume. Thus when the roller moves a certain distance along the lengths of the compartments those with a larger width and/or height will have expelled a greater volume of fluid. Hence, the infusion rate is faster for the larger volume compartment. The infusion rate is proportional to the relative volume of the compartment.

In accordance with an alternative embodiment of the invention, the fluid containing compartments may be syringe barrels each with a piston for pushing fluid out of the syringe barrel. The pressure roller may be replaced by any slidable member attached to the constant force spring. The slidable member is pulled by the constant force spring against the syringe pistons to push fluid out of the syringe barrels.

The valve 50 of the present invention shall now be described in greater detail. The external gear 26 is directly connected to an internal gear 27. The internal gear 27 meshes with a second internal gear 52. Referring now to FIGS. 4A and 4B the second internal gear 52 is connected to a threaded cylindrical member 54. The threaded cylindrical member 54 engages a threaded hole within a non-rotating valve housing member 56. As shown in FIG. 2, the non-rotating member 56 is approximately square shaped and is prevented from rotating by the wall of the housing 21. The non-rotating member 56 acts to push against a coil spring 58. The spring 58 is held between the non-rotating housing member 56 and a lower housing member 59. At the bottom of the lower housing member 59 there is a compression member 60. As the threaded cylindrical member 54 is turned to force the non-rotatable housing member 56 against the coil spring 58 pressure is exerted downwards against the lower housing member 59 and the compression member 60. Thus the compression member 60 pushes against the access tubes 38 to restrict the flow of fluid therethrough. The compression member 60 can be pushed tight enough against the resilient member 46 so that the access tubes 38 are squeezed shut therebetween.

As shown in FIG. 4B, a positive mechanical seal can be achieved by further rotating the threaded cylindrical member 54, until there is direct contact between the non-rotating housing 56 and the lower housing member 59. This is desirable for situations that require a guaranteed seal, such as when the cartridge is prefilled at a pharmacy and transported to the physician. The threaded cylindrical member 54 may be turned in the opposite direction to relieve the pressure between the compression member 60 and the resilient base 46 so that fluid may flow through the access tubes 38. Thus, the rate of fluid flow through the access tubes 38 can be controlled by merely turning the external access gear 26 to give a variable degree of flow restriction to the fluids which are subjected to a constant force by the pressure roller 28 within the pump 10. It is also possible to use other types of flow restriction valves, such as needle valves.

The position indicating strip 22 is provided so that the location of the pressure roller 28 relative to the fluid compartments 36 can be detected through an appropriate sensing system. The position indicating strip 22 is oriented lengthwise in the direction of movement of the pressure roller 28. The strip 22 can be simply a plurality of equally spaced lines for which a simple sensing mechanism in the pump 10 can determine relative position by counting the number of lines crossed by the pressure roller 28. It is preferable, however, to provide the position indicating strip with coded information indicating the absolute position of the roller. The strip may appear something like that shown in FIG. 5. Access to absolute position from coded information has the advantage of allowing for determination of the position of the roller despite occasional, vibration-induced backward movement of the roller which could be interpreted by a line counter as an additional forward movement. In order to provide highly accurate infusion rate and volume information, the coded patterns on the position indicating strip 22 may be placed very close to one another, such as 10 microns apart. Depending upon the resolution desired, other greater distances between the coded patterns may suffice. The strip 22 is preferably reflective to make it easier to optically sense position. Knowing the position of the roller, the volume of fluid which has been infused into a patient can be readily determined.

The volume of the fluid which has been infused may be determined by multiplying the cross-sectional area of each flexible compartment 36 by the value assigned to each linear position of the roller. The flexible compartments 36 of the presently preferred embodiment have tapers near the starting and ending positions of the roller. These tapers, and the corresponding changes in cross-sectional area, are known functions of the shape of the mold that is used to manufacture the molded layer 48. This geometric information is stored in the microprocessor used to compute the infusion rate.

The operation of the cartridge shall be discussed with reference to FIG. 6. It is expected that cartridges would be generally supplied with their fluid containing compartments in an empty condition. A fill adapter 64 is used in the process of filling the compartments 36 with fluid. The fill adapter 64 has a connector which snaps onto the multiple port connector 24 and includes a plurality of single lumen tubing 66 through which fluid may be injected. The external gear 26 is turned to open the access tubes 38. For each fluid, a syringe is filled with enough drug and solution to fill each fluid containing compartment 36 to capacity. The syringes containing the fluids are attached to the open ends of the tubing 66. The syringes are squeezed to expel fluid through the fill adapter 64 and into the fluid containing compartments 36. After each of the compartments has been filled in this manner, the cartridge 20 is held vertically with the connector 24 on top. The roller 28 is gently shaken in order to displace any air bubbles in the fluid containing compartments. The syringe stems are withdrawn slightly to see if any air bubbles are present. If any air bubbles appear near the multiple port connector 24, which may advantageously be made of a clear plastic material such as polycarbonate, the respective syringe stem should be slowly withdrawn until the bubble is inside the syringe. The syringe is then held in an inverted position so that the fluid may be returned to the cartridge, but the air remains in the fill adapter. Each line is double checked for air bubbles and air bubbles are pulled out of the cartridge with the syringe stems wherever necessary. After it has been ascertained that there are no air bubbles remaining in the fluid compartments within the cartridge 20, the external valve gear 26 is turned to close off the access tubes 38 as shown in FIG. 4B. The use fill adapter 64 is removed and discarded. A fluid filled cartridge is now available for use in the pump.

Referring now to FIGS. 7, 8 and 9, the infusion pump 10 of the present invention is contained within a housing 11. The housing has an opening 71 through which the multiple fluid cartridge assembly is inserted. A locking device of any type may be used to hold the cartridge 20 inside the pump 10. A sliding peg 74 is shown in the drawings for use in locking the cartridge 20 within the pump 10. The peg 74 can slide back and forth within its mount 75, but the mount 75 maintains the peg captive so that it does not fall off of the device. On the inside, the pump 10 includes a sliding member 76 attached to a constant force spring 78. A constant force spring differs from a traditional tension or extension spring in that the output of the traditional spring increases (or decreases) linearly with position changes. The constant force spring provides a relatively stable output force regardless of position. Such springs are available from Stock Drive Products (New Hyde Park, N.Y.), model number SH08J28, as well as many other manufacturers. The constant force spring 78 is a metal coil. The metal coil constant force spring 78 is mounted on an idler spool 80. In accordance with the presently preferred embodiment there are two constant force springs, one on either side of the pump. The invention may just as well be made with one or any other number of constant force springs. The idler spools 80 are mounted to the pump housing 11. The spools 80 allow the coil spring 78 to rotate but prevent the springs from translational movement within the pump. The free end of the coil springs 78 are attached to the sliding member 76. The sliding member 76 has a channel 82 on its inner portion on either side of the incoming cartridge. The channels 82 do not go all the way through the sliding member 76. Rather, the channels 82 have a stop 83 which will butt against the knobs 29 of the pressure roller 28 on the cartridge 20. When a cartridge filled with fluid is inserted into the pump 10 the knob 29 on the pressure roller slide into the channel 82 of the sliding member until they hit the stops 83. Then further insertion of the cartridge pushes the sliding member to the rear of the pump unwinding the constant force spring 78. The sliding member 76 is pulled by the springs 78 against the pressure roller 28. The pressure roller pushes against the fluid filled compartments but is prevented from movement since the flow restrictor valve 50 is closed thereby preventing fluid from exiting from the compartments. The sliding member 76 includes a groove 84 on the outer side facing the wall of the pump housing. The grooves 84 are provided for riding within a track 86 on each side of the pump housing. The grooves 84 and track 86 maintain the sliding member in proper alignment on its movement through the pump. The pumping action begins when the flow restrictor valve 50 is opened from its closed position to allow fluid to flow out through the access tubes 38. Hence, the substantially constant force provided by the spring 78 pulls the sliding member 76 and consequently the pressure roller 28 against the fluid filled compartments to push fluid out of the pump.

It would be possible to have two sliding members, one on either side of the cartridge, however, a single sliding member connected by a bar over the top of the cartridge is preferred to provide a constant force across the fluid compartments and to provide a convenient location for the optical sensing system of the present invention.

In order to control the amount of pressure exerted by the flow restrictor valve 50 on the access tubes 38 the pump 10 is provided with a motor 88. The motor 88 is provided for turning a motor gear 90. The motor gear 90 engages the external cartridge gear 26 when the cartridge is fully inserted into the pump. An electrical button switch 92 can be provided on the outside of the pump to allow a user to turn the pump on or off. The pump has the indication "STOP" on the outside of the pump next to the button so that the patient knows that he can turn the pump off by depressing the button. When the pump is started by depressing button 92 the motor 88 will cause the gear 90 to turn. This causes gear 26 to likewise rotate thereby opening the valve 50 to allow fluid to begin flowing through the access tubes 38. In order to stop the pumping action, the motor will cause gear 90 to rotate in the opposite direction so as to cause valve 50 to close upon the access tubes. A battery 94 is provided for operating the motor 88. The battery 94 is also used for providing power to the microprocessor controller of the pump for operating the optical sensing system. Only a lightweight battery 94 is required because the motor is only needed from time to time after the proper flow rate has been established. A duty cycle for the motor of less than 2 seconds every 5 minutes is possible with the present invention. The electronics and optics also use only a small amount of electric power. It is highly advantageous that the power for pumping is provided by the mechanical spring 78. This advantageously avoids the need for the heavy power packs that are typically used with motor-driven pumps and avoids the fear that the power might run out during the infusion process.

A microprocessor based controller 96 is provided on a circuit broad. An electrical connector 98 is provided so that the detachable programming unit 30 can be used to set the infusion rate in the infusion pump 10. Other parameters of the infusion process may also be set by the programming unit 30. In addition, the programming rate may be a sequence of different rates which change from one to another over a long infusion process.

In accordance with the present invention, a unique control system is provided for regulating and maintaining an infusion rate delivered by an infusion pump to a patient. The control system includes the microprocessor controller 96 and the detachable programming unit 30. It will be understood that the detailed embodiment of the control unit 96 and the programming unit 30 itself form no part of the present invention, except to the extent that it provides one programmable control means available to those of ordinary skill in the art suitable for use in carrying out the steps of the present invention, the programming techniques for adapting a microprocessor controller to such steps being well known in the microprocessor and programmable control means art.

Before turning to the steps of the infusion dosage control method of the present invention, the optical sensing system shown in FIG. 10 shall be described. An optical emitter 100 and optical detector 102 are carried on the sliding member 76 of the pump 10. Power is supplied to these devices through a flexible cable 104 connected to the control unit 96. Ultimately, of course, the power is supplied by the battery 94. The flexible cable 104 is also used to transmit information back and forth between the optical sensing system made up of the emitter 100 and detector 102 and the control unit 96. The emitter 100 may consist of a common LED or laser diode. A lens 101 may be provided to focus the light emitted by the emitter 100. The light illuminates a spot on the position indicating strip 22. Light reflected from the strip 22 is detected by a sensor which is used as the detector 102. For a simple strip 22 which contains a plurality of equally-spaced stripes, the detector 102 may be a phototransistor which is masked with a striped pattern similar to that on the position strip 22. The photo masking of the detector causes the detected spot to turn on and off as the sliding member 76 carries the emitter 100 and detector 102 across the strip 22. Commonly available NPN-Si Phototransistors such as the NTE3037 distributed by NTE Electronics, Inc. (Bloomfield, N.J. ) may serve as such sensors. Equivalently, the emitter 100 could be masked with the striped pattern so that almost any light detector could easily identify moving the distance between two stripes. Alternative emitters and detectors may be readily selected by those of ordinary skill in the art.

A more accurate strip 22 would have a pattern encoded onto the surface, as shown in FIG. 5, to allow the actual position of the roller to be determined. This encoded strip 22 would require an array sensor to serve as the detector 102. Such array sensors are manufactured by Micron Technology, Inc. (Boise, Idaho), Models IS32 OpticRam and IS6410 OpticRam. Other array sensors are also commercially available. These array sensors require the lens 101 which focuses the pattern on strip 22 onto the active detection area.

The information received by the detector 102 whether it be a coded pattern or a simple series of on-off pulses is transmitted over the cable 104 to the control unit 96 where it is interpreted by the microprocessor unit. The interpretation may be a simple matter of counting the number of lines which are passed by the sliding member 76 as it is moved or it may be a more complicated algorithm which reads the patterns inscribed on the position indicating strip 22 to determine the absolute position of the sliding member 76 and thus the location of the pressure roller 28.

As with any measurement instrument, it is necessary to calibrate the sensing mechanisms so that it can determine the amount of volume which is displaced by the pressure roller 28 as the sliding member 76 moves a certain distance. This calibration is achieved in the present embodiment of the invention, by storing position and volume profiles in the microprocessor. For any given cartridge, the relationship between the position of the sliding member 76 and the volume expelled from the compartment 36 is measured and stored in the programming unit 30. The position and volume profile for the cartridge type being used in the pump 10 is transferred into the control unit 96 of the pump 10 when a physician initializes the pump for determining its treatment regimen. The physician indicates the type of cartridge and the programming unit 30 transfers the appropriate profile to the control unit 96.

The method of the present invention for maintaining a controlled flow rate shall now be described. The unit dosage for the therapy is determined by the physician. The physician then calculates the number of milliliters, cubic centimeters or milligrams of drug or drugs which are to be administered over a given infusion time period. The volume of fluid is then determined which corresponds to the required dosage for each drug. A diluting solution may be used in the preparation of this volume, if desired by the physician. The volume of fluid is accurately measured in a measuring device, such as a syringe or graduated cylinder. Separate measuring devices are more advantageously used in the case of multiple drugs to prevent mixing. The fluids are loaded into the storage compartments of the cartridge in accordance with common safety procedures, such as air bubble removal discussed above. Then the detachable programming unit 30 is attached to the electrical connector on the pump. The programming unit will then issue prompts so that the doctor may input the identity of the cartridge and the desired regimen which the pump is to follow with respect to duration and infusion volume. Thus, the pump is informed of the volume of fluids contained in the compartments and the length of the time period over which the infusion is to take place. The pump is attached to the patient and started. The detachable programming unit 30 is then disconnected.

The programmable controller 96 in the pump receives position information from the position indicating strip 22 through the optical sensing system and the position data is interpreted. When the pressure roller reaches the end of the cartridge, the pump is stopped and the end of the cycle is indicated througn a visual or audible signal. The end of this infusion cycle may also be indicated by expiration of the infusion time period. The doctor can set a certain amount of time for the infusion to take place and at the end of that time the infusion process will be stopped and the flow restrictor valve will be closed.

The controller determines whether any change in position has occurred. If the pressure roller stops moving then the controller checks to see whether there is an occlusion. A test is performed to determine the presence of an occlusion by opening the valve slightly. If the roller still does not move, an occlusion is assumed. If it is determined that there has been an occlusion, the flow restrictor valve is closed to stop the pump and an alarm is set off visually or audibly. If no occlusion is determined to exist, then the controller returns to its program to adjust the valve for obtaining the appropriate flow rate. Other types of occlusion tests may be performed, such as measuring the pressure changes which occur in the fluid lines during the occlusion formation, but the presently preferred test is based upon an interpretation of pressure roller motion.

The controller determines the current flow rate at which the pump is operating by counting the time which has elapsed as the pressure roller moves a predetermined distance. The programmable controller has a built in time clock as is typical in the art for microprocessors. The programmable controller is provided with a program that allows it to correlate the linear position of the pressure roller to the volume of fluid which has been expelled through or from the infusion pump. As long as the microprocessor is informed of the proper position and volume profile for the particular construction of the cartridges and molded layers which will be used in the pump, the pump will function properly. When the detachable programming unit was attached to the infusion pump for setting the parameters of the infusion, the type of cartridge which was being inserted into the infusion pump was indicated to the pump. In this manner, the programmable controller of the pump will know which set of data to refer to in determining the correlation between the linear position of the pressure roller and the volume of fluid expelled from the flexible fluid filled compartments.

In accordance with the present invention, the calculated current flow rate is compared with the desired flow rate as was indicated to the control unit by the detachable programming unit 30. The error in the flow rate is determined and compared with a predeterminedd allowable error. If the allowable error has been exceeded, the controller will instruct the flow regulator to make a correction. The type of correction depends on whether a rate-dependent therapy or a dosage dependent therapy is being followed. For a rate dependent therapy, the flow restrictor valve is adjusted a small amount. The valve will continue to be adjusted until the rate error has been reduced to an acceptable level. For a dosage dependent therapy, the flow restrictor valve is adjusted opened or closed until any volume error has been substantially eliminated. The valve is then readjusted to more closely approximate the desired rate of infusion.

Further in accordance with the invention, for dosage dependent therapies in addition to checking the current flow rate for error, the controller compares the total volume which has been infused with the volume which should have been infused according to the programmed infusion regimen. If the volumetric error exceeds a predetermined limit, the flow restrictor valve is instructed to open or close until the volume error has been substantially eliminated. In the presently preferred embodiment, the maximum allowable volumetric error is 1.0 cubic centimeter of drug for the cartridge. If for example the cartridge has four 20 cc. chambers, the volumetric accuracy for each individual chamber is 0.25 cc. This corresponds to an accuracy of 1.25% for the total infusion process, regardless of the duration of the infusion. When a volumetric error has been corrected, the valve is readjusted so as to approximate the desired rate of infusion. When the infusion process progresses at the desired rate and is within the volumetric tolerances, the controller continually loops through its program checking the position being sensed, the change in position, the change in time and determining whether a rate or volumetric error exists. Most of the time no adjustment will be necessary and therefore very little electrical power is consumed. The process continues until the end of the infusion at which time the flow restrictor valve is closed.

Sample computer programs for implementing the control method of the present invention on an Apple II computer (manufactured by Apple Computer Co., Inc.) equipped with A6 T/D Timer Driver Board and A32 I/O Optically Isolated I/O Board (manufactured by Rogers Labs, Inc., Santa Ana, CA) are attached as Appendix A. A similar program may be written by one of ordinary skill in the art to operate the microprocessor selected for the controller of the device of the present invention.

In the presently preferred embodiment, an electronic control system with optical sensing capability monitors the infusion process volumetrically and any deviation from the desired rate is derived from the changes in volume that are sensed by the system. It is possible for one of ordinary skill in the art to devise other feedback sensors to accomplish the same volumetric measurement, such as by attaching strain gauges to a syringe barrel and measuring the position of the plunger.

In the presently preferred embodiment, a cartridge with a roller and one or more elastomeric chambers which can independently store a multiplicity of fluid solutions is used to hold the fluids as the roller position is being measured. Other chambers could be devised by one of ordinary skill which could be used to accomplish the same type of measurement, such as by mounting one or several syringes in a manifold and using the position of the plungers to measure the volume.

In the presently preferred embodiment, an electronic controller is used to determine if any substantial errors exist in the rate or volume of fluid delivered. Other controllers, such as a mechanical controller comprised of gears and cams, may be adapted to measure fluid delivery errors and correct for them.

Of course, it should be understood that various changes and modifications to the preferred embodiment detailed herein and to the method of administering a dosage-dependent therapy as described herein will be apparent to those skilled in the art. These changes described above and other changes can be made without departing from the spirit and scope of this invention and method, and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Irvine,CA,US
Assignee/Applicant First: I Flow Corporation,Irvine,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Irvine,CA,US
Assignee Count: 1
Inventor: Brown, Eric W.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W.
Inventor - w/address: Brown Eric W.,Redondo Beach,CA,US
Inventor Count: 1
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Rosenbaum, C. Fred / Kartchner, Gene B.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1988-05-03
Publication Month: 05
Publication Year: 1988
Application Number: US1986940044A
Application Country: US
Application Date: 1986-12-10
Application Month: 12
Application Year: 1986
Application with US Provisional: US1986940044A | 1986-12-10
Priority Number: US1986940044A
Priority Country: US
Priority Date: 1986-12-10
Priority Date - Earliest: 1986-12-10
Priority Month: 12
Priority Year(s): 1986
Earliest Priority Year: 1986
Related Application Table:
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M0005142, A61M0005148, A61M0005172, A61M000514
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M0005142
A
A61
A61M
A61M0005
A61M0005142
A61M0005148
A
A61
A61M
A61M0005
A61M0005148
A61M0005172
A
A61
A61M
A61M0005
A61M0005172
A61M000514
A
A61
A61M
A61M0005
A61M000514
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current
Current

A61M 5/142
A61M 5/148
A61M 5/172

A61M 5/1408
A61M 2209/045


20130101
20130101
20130101

EP
EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604134, 604067, 604131, D24111
US Class (divided): 604/134, 604/067, 604/131, D24/111
US Class - Main: 604134
US Class - Original: 604134 | 604067 | 604131 | D24111
ECLA: A61M0005142, A61M0005148, A61M0005172, K61M000514B1, K61M020904F
Locarno Class:
JP F Terms:
JP FI Codes:
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2014-12-30
CORE MEDICAL LTD Q
US8926561B2
2015-01-06
VERHOEF ERIK T
US8961461B2
2015-02-24
STEWART JANICE
US8979798B2
2015-03-17
SHENER CEMAL
US8986253B2
2015-03-24
DIPERNA PAUL M
USD321559S1
1991-11-12
I Flow Corporation
WO1993024893A1
1993-12-09
BAXTER INT
WO1999036112A1
1999-07-22
TANDEM MEDICAL
WO2001023277A1
2001-04-05
CARTLEDGE RICHARD G
WO2001032235A2
2001-05-10
TANDEM MEDICAL INC
WO2001032235A3
2002-06-20
TANDEM MEDICAL INC
WO2001085233A2
2001-11-15
STERLING MEDIVATIONS INC
WO2001085233A3
2002-06-06
STERLING MEDIVATIONS INC
WO2003059419A2
2003-07-24
BAXTER INT
WO2003059419A3
2003-11-06
BAXTER INT
WO2003105930A2
2003-12-24
BAXTER INT
WO2005016408A2
2005-02-24
KRIESEL MARSHALL S
WO2005016408A3
2007-02-08
KRIESEL MARSHALL S
WO2006124936A2
2006-11-23
INFUSSAFE LLC
WO2009029572A1
2009-03-05
DEKA PRODUCTS LP
Count of Citing Patents: 156
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
2000-05-03
SULP
+
Description: SURCHARGE FOR LATE PAYMENT
2000-05-03
FPAY
+
Description: FEE PAYMENT
1999-11-23
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1995-11-03
FPAY
+
Description: FEE PAYMENT
1991-10-10
FPAY
+
Description: FEE PAYMENT
1986-12-10
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, A CORP OF CA, CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNOR:BROWN, ERIC W.; REEL/FRAME:004642/0429 1986-12-09
Post-Issuance (US):
Maintenance Status (US):
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
I-FLOW CORPORATION A CORP OF CA,TORRANCE,CA,US
BROWN, ERIC W.
1986-12-09
004642/0429
1986-12-10
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER STREET BOSTON, MA 02109
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
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EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4741736A
19880503
Brown Eric W.
I FLOW CORP
Title: Programmable infusion pump
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4741736A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4741736A_&format=gif&fponly=1
Record Source: Result Set
Top
Record 7/43
US4701159AMultilumen catheter set
Publication Number: US4701159A  
Title: Multilumen catheter set
Title (Original): Multilumen catheter set
Title (English): Multilumen catheter set
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Multi-lumen connector with tissue cuff at one end of multi-lumen catheter with locking connector at other end
Abstract:


A subcutaneous catheter set is disclosed in which a multilumen catheter tube has a tissue cuff connected about its outer circumference. A lock adapter has a plurality of conduits in communication with the lumens of the multilumen catheter tube. A complementary lock adapter is connected to either another multilumen catheter tube, a plurality of single lumen lines, a plurality of injection tubes or may be plugged to act as a seal. The two lock adapters can be locked together so that the subcutaneous multilumen catheter may be connected directly to any of the items attached on the complementary lock adapter.
Abstract (English):

A subcutaneous catheter set is disclosed in which a multilumen catheter tube has a tissue cuff connected about its outer circumference. A lock adapter has a plurality of conduits in communication with the lumens of the multilumen catheter tube. A complementary lock adapter is connected to either another multilumen catheter tube, a plurality of single lumen lines, a plurality of injection tubes or may be plugged to act as a seal. The two lock adapters can be locked together so that the subcutaneous multilumen catheter may be connected directly to any of the items attached on the complementary lock adapter.
Abstract (French):
Abstract (German):
Abstract (Original):

A subcutaneous catheter set is disclosed in which a multilumen catheter tube has a tissue cuff connected about its outer circumference. A lock adapter has a plurality of conduits in communication with the lumens of the multilumen catheter tube. A complementary lock adapter is connected to either another multilumen catheter tube, a plurality of single lumen lines, a plurality of injection tubes or may be plugged to act as a seal. The two lock adapters can be locked together so that the subcutaneous multilumen catheter may be connected directly to any of the items attached on the complementary lock adapter.
Abstract (Spanish):
Claims:

We claim:
1. A multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a multilumen catheter; *
a second lock adapter having a plurality of conduits in communication with the lumens of said multilumen catheter; *
means for locking said first lock adapter to said second lock adapter, said locking means being operable to put the conduits of said second lock adapter in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one independent single lumen access line each having one end connecting to one of said ports.
2. The multilumen catheter set of claim 1 further comprising a sheath surrounding all of said at least one independent single lumen access lines adjacent the rear face of said first lock adapter.
3. The multilumen catheter set of claim 1 further comprising a luer fitting connected to a second end of each of said at least one independent single lumen access lines.
4. The multilumen catheter set of claim 1 wherein said locking means comprise shoulder means extending from first lock adapter and an internally threaded lock ring having a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
5. The multilumen catheter set of claim 1 further comprising protrusions extending from the front face of said first lock adapter, each protrusion having one of said conduits therethrough.
6. An injection adapter for a multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits so that the conduits of said second lock adapter are in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one rigid injection tube each having one end connected to one of said ports and an other end covered with a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn said plug reseals said other end of said injection tube.
7. The injection adapter of claim 6 further comprising a single lumen access line connected to one of the ports on said first lock adapter.
8. The injection adapter of claim 6 further comprising shoulder means extending from said first lock adapter and wherein said lock ring is internally threaded and has a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
9. The injection adapter of claim 6 further comprising protrusions extending from the front face of said first lock adapter, each protrusion having one of said conduits therethrough.
10. A sealing cap for a multilumen catheter set comprising: *
a first lock adapter including a plurality of protrusions in a front face, at least one of said protrusions being solid; and *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits in communication with the lumens of a multilumen catheter, said first lock adapter engaging said second lock adapter so that when locked each of said at least one solid protrusions matingly engages one of said conduits to close off said one of said conduits.
11. The sealing cap of claim 10 further comprising shoulder means extending from said first lock adapter and wherein said lock ring is internally threaded and has a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
12. The sealing cap of claim 10 wherein said at least one solid protrusion comprises a plurality of protrusions such that upon locking said first lock adapter to said second lock adapter, each of said conduits is closed off by one of said protrusions.
13. The sealing cap of claim 10 wherein one of said protrusions has a conduit therethrough and further comprising *
a rigid injection tube having one end connected to the conduit and an other end covered by a plug penstrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn said plug reseals said other end of said injection tube.
14. The sealing cap of claim 10 wherein one of said protrusions has a conduit therethrough and further comprising *
a single lumen access line connected to the conduit.
15. A subsutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a sealing cap having a plurality of solid protrusions interengageable with said plurality of conduits of said lock adapter; and *
means for locking said lock adapter to said sealing cap so that said protrusions sealingly close each of said conduits of said lock adapter.
16. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one rigid injection tube, each having one end connected to the conduit in one of said at least one of said protrusions and an other end covered by a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn, said plug reseals said other end of said at least one injection tube; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
17. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one single lumen access line, each connected to said conduit in one of said at least one of said protrusions; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
Claims Count: 17
Claims (English):

We claim:
1. A multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a multilumen catheter; *
a second lock adapter having a plurality of conduits in communication with the lumens of said multilumen catheter; *
means for locking said first lock adapter to said second lock adapter, said locking means being operable to put the conduits of said second lock adapter in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one independent single lumen access line each having one end connecting to one of said ports.
2. The multilumen catheter set of claim 1 further comprising a sheath surrounding all of said at least one independent single lumen access lines adjacent the rear face of said first lock adapter.
3. The multilumen catheter set of claim 1 further comprising a luer fitting connected to a second end of each of said at least one independent single lumen access lines.
4. The multilumen catheter set of claim 1 wherein said locking means comprise shoulder means extending from first lock adapter and an internally threaded lock ring having a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
5. The multilumen catheter set of claim 1 further comprising protrusions extending from the front face of said first lock adapter, each protrusion having one of said conduits therethrough.
6. An injection adapter for a multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits so that the conduits of said second lock adapter are in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one rigid injection tube each having one end connected to one of said ports and an other end covered with a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn said plug reseals said other end of said injection tube.
7. The injection adapter of claim 6 further comprising a single lumen access line connected to one of the ports on said first lock adapter.
8. The injection adapter of claim 6 further comprising shoulder means extending from said first lock adapter and wherein said lock ring is internally threaded and has a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
9. The injection adapter of claim 6 further comprising protrusions extending from the front face of said first lock adapter, each protrusion having one of said conduits therethrough.
10. A sealing cap for a multilumen catheter set comprising: *
a first lock adapter including a plurality of protrusions in a front face, at least one of said protrusions being solid; and *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits in communication with the lumens of a multilumen catheter, said first lock adapter engaging said second lock adapter so that when locked each of said at least one solid protrusions matingly engages one of said conduits to close off said one of said conduits.
11. The sealing cap of claim 10 further comprising shoulder means extending from said first lock adapter and wherein said lock ring is internally threaded and has a base abutting said shoulder means so that when said ring is screwed onto the second lock adapter, said first lock adapter is brought into sealing contact with said second lock adapter.
12. The sealing cap of claim 10 wherein said at least one solid protrusion comprises a plurality of protrusions such that upon locking said first lock adapter to said second lock adapter, each of said conduits is closed off by one of said protrusions.
13. The sealing cap of claim 10 wherein one of said protrusions has a conduit therethrough and further comprising *
a rigid injection tube having one end connected to the conduit and an other end covered by a plug penstrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn said plug reseals said other end of said injection tube.
14. The sealing cap of claim 10 wherein one of said protrusions has a conduit therethrough and further comprising *
a single lumen access line connected to the conduit.
15. A subsutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a sealing cap having a plurality of solid protrusions interengageable with said plurality of conduits of said lock adapter; and *
means for locking said lock adapter to said sealing cap so that said protrusions sealingly close each of said conduits of said lock adapter.
16. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one rigid injection tube, each having one end connected to the conduit in one of said at least one of said protrusions and an other end covered by a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn, said plug reseals said other end of said at least one injection tube; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
17. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one single lumen access line, each connected to said conduit in one of said at least one of said protrusions; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a multilumen catheter; *
a second lock adapter having a plurality of conduits in communication with the lumens of said multilumen catheter; *
means for locking said first lock adapter to said second lock adapter, said locking means being operable to put the conduits of said second lock adapter in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one independent single lumen access line each having one end connecting to one of said ports.
Independent Claims:
1. A multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a multilumen catheter; *
a second lock adapter having a plurality of conduits in communication with the lumens of said multilumen catheter; *
means for locking said first lock adapter to said second lock adapter, said locking means being operable to put the conduits of said second lock adapter in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one independent single lumen access line each having one end connecting to one of said ports.
6. An injection adapter for a multilumen catheter set comprising: *
a first lock adapter including a plurality of conduits providing communication between a plurality of openings in a front face of said first lock adapter and a plurality of ports in a rear face of said first lock adapter; *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits so that the conduits of said second lock adapter are in communication through the front face of said first lock adapter with the conduits of said first lock adapter; and *
at least one rigid injection tube each having one end connected to one of said ports and an other end covered with a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn said plug reseals said other end of said injection tube.
10. A sealing cap for a multilumen catheter set comprising: *
a first lock adapter including a plurality of protrusions in a front face, at least one of said protrusions being solid; and *
a lock ring for achieving locking engagement between said first lock adapter and a second lock adapter having a plurality of conduits in communication with the lumens of a multilumen catheter, said first lock adapter engaging said second lock adapter so that when locked each of said at least one solid protrusions matingly engages one of said conduits to close off said one of said conduits.
15. A subsutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a sealing cap having a plurality of solid protrusions interengageable with said plurality of conduits of said lock adapter; and *
means for locking said lock adapter to said sealing cap so that said protrusions sealingly close each of said conduits of said lock adapter.
16. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one rigid injection tube, each having one end connected to the conduit in one of said at least one of said protrusions and an other end covered by a plug penetrable by a needle and resealable so that when a needle inserted through said plug into said tube is withdrawn, said plug reseals said other end of said at least one injection tube; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
17. A subcutaneous catheter set comprising: *
a multilumen catheter tube having one end with an exit port for each lumen and an other end; *
a tissue cuff connected around an outer circumference of said catheter tube; *
a first lock adapter including a plurality of ports connected to the lumens of said catheter tube and a plurality of conduits each connected to one of said ports; *
a second lock adapter having a plurality of protrusions interengageable with said plurality of conduits of said first lock adapter, at least one of said protrusions having a conduit therethrough; *
at least one single lumen access line, each connected to said conduit in one of said at least one of said protrusions; and *
means for locking said first lock adapter to said second lock adapter so that said protrusions are sealingly engaged with said conduits of said first lock adapter.
Description:

BACKGROUND OF THE INVENTION

This invention relates to a multilumen catneter set, in particular, one for a subcutaneous route for intravenous infusions.

It has been found convenient for patients who are receiving frequent infusions to provide them with a tunneled subcutaneous catheter. Such a catheter is inserted underneath the skin of the patient and then into a vein. A tissue cuff is provided on the catheter near the skin so that the skin may grow into it and hold the catheter in place. An adapter is located on the end of the catheter, above the skin. Into which a mating connector may be attached to connect the subcutaneously tunneled catheter with an external catheter. The external catheter may be used for infusion of fluids or for extraction of body fluid for testing.

Since there are times when more than one infusion or operation using the catheter set may be desirable, dual lumen subcutaneously tunneled catheters have been developed. The two lumens are fused together underneath the skin of the patient. Above the skin the lumens are separated and each is provided with an adapter for separate connection to an outside source. This arrangement can be cumbersome for a patient since there are two tubes and adapters hanging from the implanted catheter and would be even more cumbersome if the implanted catheter has more than two lumens. Furthermore, if one of the single lumen extensions projecting from the implanted multilumen catheter should break off, the entire catheter set may need to be surgically replaced.

Experimentation and advances in medicine are creating new needs for infusing a multiplicity of fluids into a patient. There are many applications for which there is a need for a device which can intravenously administer a plurality of drug solutions. One such application is the use of chemotherapy to treat such diseases as cancer. Attempts at providing more advanced chemotherapy regimens involving the intravenous administration of a multiplicity of drug solutions are being inhibited by a lack of equipment to simplify such a procedure. Very often, if different drug solutions are used, they are administered by using a separate catheter tube for each drug. This may require a separate pump for each catheter tube line which would increase costs.

There is thus a need for new catheter equipment which offers greater patient comfort and provides doctors with greater convenience in experimenting and using new treatments that involve a plurality of drug solutions.

SUMMARY OF THE INVENTION

The present invention is directed to a subcutaneously tunneled catheter set which includes a multilumen catheter for insertion under the skin of a patient. The catheter includes a tissue cuff about its outer circumference. At the outermost end of the catheter, a lock adapter of the present invention is attached. The adapter includes a plurality of ports for connection with each of the lumens in the catheter. A conduit is located in the adapter between each port and a mating face. A complementary lock adapter is attached to an external multilumen catheter, a plurality of single lumen access lines, or a plurality of injection tubes. The complementary lock adapter may instead have solid protrusions for closing off conduits of said first adapter or may have a combination of single lumen catneters, injection tubes and solid protrusions. A device is provided for locking the two adapters together. They are locked in such a way that the conduits provide communication between the lumens of the subcutaneously tunneled catheter and the lumens of the external multilumen catheter, the single lumen access lines, the injection tubes, or the solid protrusions depending upon which are carried by the complementary lock adapter.

The subcutaneously tunneled catheter may be connected by a multilumen connector to a second reinforced multilumen catheter. The multilumen connector may advantageously be tube. The multilumen connector may advantageously be provided with a tissue cuff about its circumference so that one will not be required about the catheter.

The multilumen catheter set of the present invention advantageously provides the ability for long term regimens of drug treatment involving a plurality of drug solutions. The wire reinforced catheter may be used to advantageously avoid blockage of the catheter because of bending of the catheter tube. The multilumen locking connector advantageously allows the use of a variety of different external input devices with the subcutaneously tunneled catheter set.

A single pump which may be used in conjunction with the catheter set of the present invention is described in pending patent application U.S. Ser. No. 677,849, filed Dec 5, 1984 entitled "Infusion Pump", sharing the same assignee as the present invention. The disclosure of said application is hereby incorporated by reference herein.

Other objects and advantages of the present invention will become apparent during the following description of the presently preferred embodiment of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of the catheter set of the present invention being used in a patient.

FIG. 2 is a plan view of a first embodiment of the catheter set of the present invention in partial cross-section.

FIG. 3 is a cross-sectional view of the multilumen connector of the present invention.

FIG. 3A is an end view of the multilumen connector of FIG. 3 taken along lines A--A.

FIG. 3B is an end view of the multilumen connector of FIG. 3 taken along lines B--B.

FIG. 4 is a cross-sectional view of the multilumen locking connector of the present invention.

FIG. 4A is an end view of the multilumen locking connector of FIG. 4 taken through lines A--A.

FIG. 4B is an end view of the multilumen locking connector of FIG. 4 taken through lines B--B.

FIG. 5 is a plan view of a second embodiment of the present invention.

FIG. 6 is a plan view of a multibranch adapter of the present invention.

FIG. 7A is a plan view of the lock adapter of the present invention fitted with injection tubes.

FIG. 7B is a bottom view of the lock adapter of FIG. 7A.

FIG. 8 is a plan view of the sealing cap of the present invention.

FIG. 9 is a perspective view of a multipurpose adapter of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to FIG. 1, the multilumen subcutaneously tunneled cather set 100 of the present invention is inserted and used in a patient in a manner similar to that of the well known Hickman catheter sets. According to the present invention. A subcutaneously tunneled multilumen catheter tube 10 is surgically inserted under the skin and into a vein of the patient. The lumens are provided with an exit port 12 at the end of the multilumen catheter tube 10. Near the other end of the subcutaneously tunneled multilumen catheter tube there is a tissue cuff 20 into which fibrous tissue of the patient grows to anchor the catheter set and to reduce the likelihood of infection.

A reinforced catheter tube 30 extends from the tissue cuff 20 out of the patient and ends with a multilumen locking connector adapter 40. Since the catheter tubes are very small in diameter, bending a multilumen catheter tube may have a tendency to close off one of the lumens with a kink in the outer layer of tubing. To make the exterior catheter tube kink-proof, reinforcement is provided in the multilumen catheter 30. In accordance with the preferred reinforcement as shown in FIG. 2, the catheter 30 is reinforced with a wire coil 32. The wire coil 32 may be additionally used in some applications to conduct electrical information from a sensor located at the patient's body back to diagnostic instruments. The multilumen locking connector adapter 40 is covered with a sealing cap such as that shown in FIG. 8 when the catheter set is not in use. In a multilumen catheter, since the walls of each lumen are often much smaller than the walls of a single catheter tube, the likelihood of a blockage due to kinking when the tube is bent is greater. To make the exterior catheter tube kink-proof, reinforcement is provided in the multilmen catheter 30. In accordance with the preferred embodiment as shown in FIG. 2, the catheter 30 is reinforced with a wire coil 32. The wire coil 32 may be additionally used in some applications to conduct electrical information from a sensor located at the patient's body back to diagnostic instruments.

Referring now to FIGS. 3, 3A and 3B, the multilumen connector of the present invention is shown. This connector 50 has a plurality of ports 52 at one end onto which the lumens of the suocutaneously tunneled multilumen catheter tube 10 are bonded in a conventional manner. At the opposite end of the connector 50, a corresponding plurality of ports 54 are provided for bonding with the lumens of the reinforced catheter 30. The shaoes of the lumens illustrated in FIGS. 3A and 3B differ. Nevertheless, the lumens in the multilumen catheters of the present invention may be any useable shape and they may be the same at both ends of the connector 50. It is desirable, however, that the lumens be shaped in the subsutaneously tunneled multilumen catheter tube so that the maximum amount of fluid flow is allowed in a minimum amount of space. The ports 52 and 54 at opposite ends of the connectors are in communication with one another via conduits 56. Thus, when the connector is hooked up on either end to multilumen catheter tube, the lumens of the two tubes are in communication with one another. According to the present invention, the preferred placement for the tissue cuff 20 is around the outer circumference of the multilumen connector 50 as shown in FIG. 3. The cuff 20 may be glued, thermally melted or bonded to the connector 50 by any other conventional bonding method.

FIGS. 4, 4A and 4B illustrate the multilumen locking connector for connecting the catheter set of the present invention with an external multilumen catheter tube 80. The external multilumen catheter tube 80 is preferably reinforced to avoid kinking. According to the preferred embodiment the multilumen locking connector 60 is made with a female lock adapter 40, a male lock adapter 62 and a locking ring 64. The female lock adapter 40 includes a plurality of ports 43 onto which the lumens of the reinforced catheter tube 30 are bonded. On the opposite side of the female lock adapter 40 is a mating face 45 which includes a plurality of incentations 46. A conduit 41 passes from each port 43 to the mating face 45. The indentations 46 are located at each conduit 42. A ring 48 including two tabs 49 is shown surrounding the outer circumference of the female adapter 40. The tabs 49 are used for engaging the locking ring 64.

The male multilumen lock adapter 62 is likewise provided with a plurality of ports 65 for fitting within and bonding to its respective multilumen catheter tube. Conduits 66 connect each port 65 to the mating face 67 at the other end of the male adapter 62. The mating face 67 of the male lock connector includes a protrusion 68 at each conduit 66. The protrusions 68 match the indentations 46 of the female lock connector 40 so that the two mating faces 67 and 45 may be interengaged.

The lumens in a multilumen catheter are symmetrically arranged about the center. The conduits in the multilumen locking connector 60 may likewise be symmetrically arranged. However, it may be useful to provide asymmetry or a matching groove and notch in the two mating faces so that the mating faces cannot be interengaged in any other than one position. This will ensure that each time an exterior multilumen catheter tube 80 is attached to the subcutaneously tunneled multilumen catherter set 100 the same lumens will be connected. Therefore, the same drug solutions may be delivered through the plurality of lumens without fear of unwanted mixing in the subcutaneously tunneled catheter set 100. The asymmetry about the center may be provided by giving an irregular shape to one or more of the protrusions and indentations or by an asymmetric positioning of the protrusions and indentations which may be accommodated by directing the conduits in other than a straight line.

The male lock adapter 62 is provided with a shoulder 69 on its outer circumference. The shoulder 69 is provided for abutment against the locking ring 64. The locking ring 64 includes a base 71 and a set of inner threads 73. The base 71 encircles the male lock adapter 62 and is located at the side of the shoulder 69 near the ports 65. Upon interengagement of the faces of the male and female lock adapters. the locking ring 64 may be screwed onto the female lock adapter 40. The tabs 49 of the female lock adapter 40 engage the threads 73 of the locking ring 64 as it is being screwed. When the base 71 of the ring 64 comes into abutment with the shoulder 69 of the male lock adapter 62, the locking ring 64 will be pulling the male and female lock adapters together and may thereby provide a tight seal.

According to a second embodiment of the present invention, it may be uneconomical at times to provide a wire reinforced catheter. As shown in FIG. 5, a single multilumen catheter 10 may be provided with a tissue cuff 20 near its external end. The length of the catheter extending from the patient may be minimized to help avoid kinking. A female lock adapter 40 is connected to the end of the multilumen catheter 10 to provide easy attachment of a variety of adapters, caps and catheters to the implanted catheter. In FIG. 5, the lock adapter 40 is connected to a male lock adapter 62 which is attached to an external multilumen catheter 80.

Referring now to FIG. 6, a multibranch adapter 110 is shown which may be locked onto a multilumen catheter set. The adapter includes a male lock adapter 62 for making a locking connection to the female lock adapter 40 of the subcutaneously tunneled catheter. A single lumen access line 112 is bonded by conventional methods to each of the ports 65 of the male lock adapter. The single lumen access lines 112 may be provided with luer fittings 116 at their outer ends. The luer fittings allow the lumens to be connected in a conventional manner to syringes, pumps, monitors or other hospital equipment having complementary luer fittings. In the preferred embodiment, a protective sheath 114 is located around the bundle of single lumen lines adjacent the rear of the male lock adapter. The protective sheath 114 helps to strengthen the multibranch adapter 110 to help prevent a single lumen line from breaking off from the adapter. However, if a single access line should break off, it is only necessary with the present invention to replace the multibranch adapter with a new multibranch adapter. This is an advantage over prior art catneter sets in which a broken access line may require surgical replacement of the catheter set.

Rather than proceeding with a long infusion process, there are occasions on which a doctor wishes to inject drugs from a syringe into an implanted catheter set or withdraw blood from an implanted catherer set using a syringe. An injection adapter 120 as shown in FIGS. 7A and 7B, provides the doctor with the ability to use a syringe with a standard hypodermic needle to inject fluids into a patient. The injection adapter includes a male lock adapter 62 and a plurality of injection tubes 122 bonded the ports 65 of the male lock adapter 62. The injection tubes 122 are made of rapid plastic tubing which is difficult to pierce. Termination plugs 124 fit into the ends of the injection tubes 122. The plugs 124 are made of a self-sealing rubber, such as silicone. A needle may be inserted through a plug 124 to withdraw blood or inject a fluid. Upon withdrawing the needle from the plug 124, the plug reseals itself.

When the multilumen catheter set is not in use. It is desirable to place a sealing cap 130 on the female adapter 40. The sealing cab 130 is constructed like a male lock adapter 62, however, rather than conduits 66, the sealing cab 130 has solid protrusions 132. Alternatively, a male lock adapter 62 may be used in conjunction with plugs which fit into the conduits 66 to block any fluid flow through the conduits. The sealing cap 130 includes a top shoulder 134 which keeps locking ring 64 from coming off the cab.

A multipurpose cap which combines the functions of the injection adapter, octopus adapter and sealing cab is also possible. Referring to FIG. 9, the mutipurpose cap 140 includes an injection tube 122, a single lumen access line 112 and two plugs 144. Although only one particular combination is illustrated, any other desirable combination of injection tubes, single lumen access lines and plugs is also possible. The multipurpose cap shown in FIG. 9 permits infusion of a fluid through one lumen of the catheter set and hypooermic injections through a second lumen of the set.

According to the present invention, it is no longer necessary to provide a number of single lumen catheters for infusing a patient with a plurality of drug solutions. Single lumens may be used, if desired, but the present invention advantageously provides the ability to hook a single multilumen catheter to the patient for provision of an infusion regimen involving a number of drug solutions. Therefore, only a single pump is required to provide an infusion of fluids to the patient. Using a multilumen catheter is especially advantageous where the drug solutions may not be mixed together and provided in a single tube. A further advantage of the present invention is that only a single sealing cap is required to close off the implanted catheter set. Prior art multilumen systems which have a number of single lumen catheters hanging from the patient would require a cap for each lumen. These prior art catheter sets are more bulky, are more susceptible to being pulled upon while a patient is dressing or undressing and are more noticeable under clothing.

Of course, it should be understood that various changes and modifications to the preferred embodiment described above will be apparent to those skilled in the art. For example, a snapping mechanism may be used to replace the screwable locking ring of the multilumen locking connector. Also, any appropriate number of lumens may be used, the invention is not restricted to the four shown. These and other changes can be made without departing from the spirit and scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Irvine,CA,US
Assignee/Applicant First: I Flow Corporation,Irvine,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Irvine,CA,US
Assignee Count: 1
Inventor: Brown, Eric W. | Tai, Henry T.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W. | Tai, Henry T.
Inventor - w/address: Brown Eric W.,Redondo Beach,CA,US | Tai Henry T.,Pacific Palisades,CA,US
Inventor Count: 2
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Truluck, Dalton L.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1987-10-20
Publication Month: 10
Publication Year: 1987
Application Number: US1985795906A
Application Country: US
Application Date: 1985-11-07
Application Month: 11
Application Year: 1985
Application with US Provisional: US1985795906A | 1985-11-07
Priority Number: US1984678481A
Priority Country: US
Priority Date: 1984-12-05
Priority Date - Earliest: 1984-12-05
Priority Month: 12
Priority Year(s): 1984
Earliest Priority Year: 1984
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US1984678481A
1984-12-05
US4581012A
1986-04-08
Continuation-in-part
Granted
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M000100, A61M0005158, A61M003910
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M000100
A
A61
A61M
A61M0001
A61M000100
A61M0005158
A
A61
A61M
A61M0005
A61M0005158
A61M003910
A
A61
A61M
A61M0039
A61M003910
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current
Current

A61M 39/0247
A61M 5/1582
A61M 39/10

A61M 2039/1077



20130101
20130101
20130101

EP
EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604043, 604175, 604256, 604533, 604283, 2851371
US Class (divided): 604/043, 604/175, 604/256, 604/533, 604/283, 285/1371
US Class - Main: 604043
US Class - Original: 604043 | 604175 | 604256 | 604283 | 2851371
ECLA: A61M003902T, A61M0005158B, A61M003910, K61M003910W
Locarno Class:
JP F Terms:
JP FI Codes:
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Title: Luer cap
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AU2005212372A1
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COVIDIEN AG
EP1227853B1
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COLOPLAST AS
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BICORE MONITORING SYSTEMS
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2004-06-09
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KCI LICENSING INC
JP04503025B2
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SHERWOOD SERVICES AG
JP05112343B2
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RENISHAW IRELAND LTD
JP2007521926A
2007-08-09
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CHO KYUNG RAN
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2011-03-03
BRACCO DIAGNOSTICS INC
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I FLOW CORP
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1991-10-22
MALLINCKRODT MEDICAL INC
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1993-03-30
BICORE MONITORING SYSTEMS
US5207648A
1993-05-04
KENDALL &amp; CO
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1993-05-11
UNIV MISSOURI
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1993-06-22
MAHURKAR SAKHARAM D
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1994-08-16
GAMBRO AB
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1994-10-25
RESEARCH MEDICAL INC
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1994-12-20
MAHURKAR; SAKHARAM D
US5405269A
1995-04-11
STUPECKY; JOSEF J
US5405320A
1995-04-11
UNIV MISSOURI
US5486159A
1996-01-23
MAHURKAR; SAKHARAM D
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1996-04-23
UNIV MISSOURI
US5569182A
1996-10-29
UNIV MISSOURI
US5599317A
1997-02-04
HAUSER; JEAN-LUC
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1998-08-25
VAS CATH INC
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1999-10-05
TWARDOWSKI; ZBYLUT J
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2001-03-27
VAS CATH INC
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MACDONALD JOHN J
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2003-06-24
J &amp; R MEDICAL DEVICES INC
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2003-08-19
SCIMED LIFE SYSTEMS INC
US7066914B2
2006-06-27
BIRD PRODUCTS CORP
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2006-08-22
BARD INC C R
US7182746B2
2007-02-27
SHERWOOD SERV AG
US7198611B2
2007-04-03
BAXTER HEALTHCARE SA
US7229429B2
2007-06-12
VAS CATH INC
US7232419B2
2007-06-19
BAXTER HEALTHCARE SA
US7331613B2
2008-02-19
MEDTRONIC INC
US7387624B2
2008-06-17
MEDTRONIC INC
US7393339B2
2008-07-01
BARD INC C R
US7537245B2
2009-05-26
MEDTRONIC INC
US7578803B2
2009-08-25
BARD INC C R
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2009-09-08
COLOPLAST AS
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2009-12-29
BARD INC C R
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2010-03-16
MEDTRONIC INC
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2010-03-16
KCI LICENSING INC
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2010-04-13
UNIV MISSOURI
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2010-12-21
BARD INC C R
US7875019B2
2011-01-25
BARD INC C R
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2011-02-08
BARD INC C R
US7976518B2
2011-07-12
CORPAK MEDSYSTEMS INC
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2011-07-26
RENISHAW PLC
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2011-09-20
BARD INC C R
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2011-11-29
GREGERSEN COLIN S
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2011-12-27
ROME GUY
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2012-01-10
MOEHLE RYAN T
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2012-04-10
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2012-04-17
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2012-05-15
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2012-06-26
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2012-10-23
GREGERSEN COLIN S
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2012-12-25
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2013-02-19
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2013-03-26
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2013-06-04
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2013-08-06
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2013-09-24
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2013-12-03
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US8608702B2
2013-12-17
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2014-11-25
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1999-11-16
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Count of Citing Patents: 99
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
1999-10-20
SULP
+
Description: SURCHARGE FOR LATE PAYMENT
1999-10-20
FPAY
+
Description: FEE PAYMENT
1999-05-11
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1995-04-20
FPAY
+
Description: FEE PAYMENT
1991-04-19
FPAY
+
Description: FEE PAYMENT
1985-11-07
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, P. O. BOX 7000-622 REDONDO BEA ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNORS:BROWN, ERIC W.; TAI, HENRY T.; REEL/FRAME:004481/0425 1985-11-04
Post-Issuance (US):
Maintenance Status (US):
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
I-FLOW CORPORATION A CORP OF CALIFORNIA,REDONDO BEACH,CA,US
BROWN, ERIC W.
1985-11-04
004481/0425
1985-11-07
TAI, HENRY T.
1985-11-04
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS CUSHMAN & PFUND 130 WATER STREET BOSTON, MA. 02109
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
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License (EP) - Licensee name:
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Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4701159A
19871020
Brown Eric W.
I FLOW CORP
Title: Multilumen catheter set
EP185977A1
19860702
Brown Eric W.
I FLOW CORP
Title: Multilumen catheter set
US4581012A
19860408
Brown Eric W.
I FLOW CORP
Title: Multilumencatheter set
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4701159A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4701159A_&format=gif&fponly=1
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Record 8/43
US4695273AMultiple needle holder and subcutaneous multiple channel infusion port
Publication Number: US4695273A  
Title: Multiple needle holder and subcutaneous multiple channel infusion port
Title (Original): Multiple needle holder and subcutaneous multiple channel infusion port
Title (English): Multiple needle holder and subcutaneous multiple channel infusion port
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Multiple needle holder for multi-lumen catheter connector has housing mounting needles to align with lumens
Abstract:


A multiple needle holder and multiple channel subcutaneous infusion port are disclosed. The multiple needle holder carries a plurality of needles which are each in separate fluid communication with a lumen of a plurality of lumens in a multilumen catheter. The multiple infusion port includes a septum which overlies a plurality of isolated chambers. Each chamber is accessed by a tube which connects to a different lumen of a subcutaneous multilumen catheter. When the needles of said needle holder are inserted through the septum of said infusion port each of said needles is in communication with a different one of said isolated chambers.
Abstract (English):

A multiple needle holder and multiple channel subcutaneous infusion port are disclosed. The multiple needle holder carries a plurality of needles which are each in separate fluid communication with a lumen of a plurality of lumens in a multilumen catheter. The multiple infusion port includes a septum which overlies a plurality of isolated chambers. Each chamber is accessed by a tube which connects to a different lumen of a subcutaneous multilumen catheter. When the needles of said needle holder are inserted through the septum of said infusion port each of said needles is in communication with a different one of said isolated chambers.
Abstract (French):
Abstract (German):
Abstract (Original):

A multiple needle holder and multiple channel subcutaneous infusion port are disclosed. The multiple needle holder carries a plurality of needles which are each in separate fluid communication with a lumen of a plurality of lumens in a multilumen catheter. The multiple infusion port includes a septum which overlies a plurality of isolated chambers. Each chamber is accessed by a tube which connects to a different lumen of a subcutaneous multilumen catheter. When the needles of said needle holder are inserted through the septum of said infusion port each of said needles is in communication with a different one of said isolated chambers.
Abstract (Spanish):
Claims:

I claim:
1. A multiple needle holder comprising: *
a housing having a housing wall surrounding a plurality of conduits extending from a rear face on said housing to a front face; *
a plurality of needles secured within said housing so that each of said needles is in communication with one of the said conduits, said needles extending outwards from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said conduits, said engagement ports being arranged so as to be matingly aligned with a plurality of ports on a multilumen catheter connector; and *
means extending outwardly from said housing wall for engaging a locking mechanism.
2. The needle holder of claim 1 wherein said means for engaging a locking mechanism comprises a flange extending outwardly from said housing wall.
3. The needle holder of claim 1 wherein each of said plurality of needles is curved.
4. The needle holder of claim 1 wherein the rear face of said housing is perpendicular to the front face of said housing.
5. A multiple channel infusion port comprising: *
a housing including a housing wall and a base; *
a penetrable self-sealing septum held within said housing and having an outer face adjacent at least one opening in said housing and an inner face on the opposite side of said septum from said outer face; *
a plurality of isolated chambers adjacent the inner face of said septum; *
a sealing wall separating each of said isolated chambers from one another; and *
a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.
6. The mutliple channel infusion port of claim 5 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.
7. The multiple channel infusion port of claim 5 further comprising slot means in the base of said housing for enabling sutures to be applied therethrough.
8. The multiple channel infusion port of claim 5 wherein said housing includes a top portion having solid portions overlying said sealing wall and openings superimposed over said chambers.
9. A multiple needle holder and infusion port comprising: *
a housing having a rear face and a front face, *
a plurality of needles secured within said housing and extending from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said needles; and *
an infusion port having a plurality of isolated chambers beneath a self-sealing septum such that when the needles of said needle holder penetrate through said septum each needle is in communication with a different one of said chambers.
10. The multiple needle holder and infusion port of claim 9 wherein said infusion port includes a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.
11. The multiple needle holder and infusion port of claim 10 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.
12. The multiple needle holder and infusion port of claim 9 further comprising slot means on said infusion port for enabling sutures to be applied therethrough.
13. The multiple needle holder and infusion port of claim 9 wherein the rear face of said housing is perpendicular to the front face of said housing.
Claims Count: 13
Claims (English):

I claim:
1. A multiple needle holder comprising: *
a housing having a housing wall surrounding a plurality of conduits extending from a rear face on said housing to a front face; *
a plurality of needles secured within said housing so that each of said needles is in communication with one of the said conduits, said needles extending outwards from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said conduits, said engagement ports being arranged so as to be matingly aligned with a plurality of ports on a multilumen catheter connector; and *
means extending outwardly from said housing wall for engaging a locking mechanism.
2. The needle holder of claim 1 wherein said means for engaging a locking mechanism comprises a flange extending outwardly from said housing wall.
3. The needle holder of claim 1 wherein each of said plurality of needles is curved.
4. The needle holder of claim 1 wherein the rear face of said housing is perpendicular to the front face of said housing.
5. A multiple channel infusion port comprising: *
a housing including a housing wall and a base; *
a penetrable self-sealing septum held within said housing and having an outer face adjacent at least one opening in said housing and an inner face on the opposite side of said septum from said outer face; *
a plurality of isolated chambers adjacent the inner face of said septum; *
a sealing wall separating each of said isolated chambers from one another; and *
a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.
6. The mutliple channel infusion port of claim 5 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.
7. The multiple channel infusion port of claim 5 further comprising slot means in the base of said housing for enabling sutures to be applied therethrough.
8. The multiple channel infusion port of claim 5 wherein said housing includes a top portion having solid portions overlying said sealing wall and openings superimposed over said chambers.
9. A multiple needle holder and infusion port comprising: *
a housing having a rear face and a front face, *
a plurality of needles secured within said housing and extending from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said needles; and *
an infusion port having a plurality of isolated chambers beneath a self-sealing septum such that when the needles of said needle holder penetrate through said septum each needle is in communication with a different one of said chambers.
10. The multiple needle holder and infusion port of claim 9 wherein said infusion port includes a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.
11. The multiple needle holder and infusion port of claim 10 further comprising a multilumen catheter, each lumen of said catheter being in communication with one of said access tubes.
12. The multiple needle holder and infusion port of claim 9 further comprising slot means on said infusion port for enabling sutures to be applied therethrough.
13. The multiple needle holder and infusion port of claim 9 wherein the rear face of said housing is perpendicular to the front face of said housing.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A multiple needle holder comprising: *
a housing having a housing wall surrounding a plurality of conduits extending from a rear face on said housing to a front face; *
a plurality of needles secured within said housing so that each of said needles is in communication with one of the said conduits, said needles extending outwards from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said conduits, said engagement ports being arranged so as to be matingly aligned with a plurality of ports on a multilumen catheter connector; and *
means extending outwardly from said housing wall for engaging a locking mechanism.
Independent Claims:
1. A multiple needle holder comprising: *
a housing having a housing wall surrounding a plurality of conduits extending from a rear face on said housing to a front face; *
a plurality of needles secured within said housing so that each of said needles is in communication with one of the said conduits, said needles extending outwards from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said conduits, said engagement ports being arranged so as to be matingly aligned with a plurality of ports on a multilumen catheter connector; and *
means extending outwardly from said housing wall for engaging a locking mechanism.
5. A multiple channel infusion port comprising: *
a housing including a housing wall and a base; *
a penetrable self-sealing septum held within said housing and having an outer face adjacent at least one opening in said housing and an inner face on the opposite side of said septum from said outer face; *
a plurality of isolated chambers adjacent the inner face of said septum; *
a sealing wall separating each of said isolated chambers from one another; and *
a plurality of access tubes each in communication with one of said isolated chambers for conducting fluid out of the isolated chambers.
9. A multiple needle holder and infusion port comprising: *
a housing having a rear face and a front face, *
a plurality of needles secured within said housing and extending from the front face of said housing; *
a plurality of engagement ports on the rear face of said housing each having an opening in communication with one of said needles; and *
an infusion port having a plurality of isolated chambers beneath a self-sealing septum such that when the needles of said needle holder penetrate through said septum each needle is in communication with a different one of said chambers.
Description:

BACKGROUND OF THE INVENTION

This invention relates to devices for providing infusions of a plurality of fluids repeatably to a patient. In particular, the invention relates to a multiple needle holder and subcutaneous multiple channel infusion port.

Implantable vascular access devices are well known in the art. A conventional implantable port includes a single reservoir having a catheter attached thereto. The catheter is fed into a blood vessel in a patient's body. Fluid injected into the reservoir of the implanted port flows through the catheter and into the blood stream. The infusion port is implanted beneath the skin of the patient. The top of the port has a septum which is penetrable by a hypodermic needle. Thus, conventional injections of medicament into a patient having an implanted port are made by inserting a needle through the patient's skin and through the septum in the infusion port. Fluid is injected through the needle and into the reservoir of the port where it passes into the catheter and out into the blood stream.

Experimentation and advances in medicine are creating new needs for infusing more than a single fluid into a patient. There are many applications for which there is a need for intravenous administration of a plurality of fluid solutions. One such application is the use of chemotherapy to treat such diseases as cancer. Attempts at providing more advanced chemotherapy regimens involving the intravenous administration of a multiplicity of drug solutions are being inhibited by a lack of equipment to simplify such a procedure. The use of implanted infusion ports for delivering drug solutions to a patient are desirable since they deliver the fluid solution directly into the blood stream where it is quickly delivered throughout the body.

A dual reservoir double lumen implantable vascular access port is presently available. This dual lumen implantable port made available by Cormed, Inc. of Medina, New York has two separate stainless steel reservoirs mounted in a silicone rubber base. Each reservoir is connected to an individual branch of a double lumen catheter. Each reservoir has its own septum through which a needle may be inserted to inject fluid into a patient. This dual lumen port has the limitation of only allowing for the injection of two fluids simultaneously. A further disadvantage of this device is that, when used for continuous infusion, two separate catheters would hang from the patient, each connected to one of two needles.

SUMMARY OF THE INVENTION

This invention is directed to a multiple needle holder adapted for engagement with a multilumen locking connector and a subcutaneous multiple channel infusion port.

According to the multiple needle holder of the present invention, a plurality of needles extend from the front face of a housing. At the rear of the housing are a plurality of inlet openings each opening provided in a separate engagement port. A flange extends from the housing for engagement with a locking ring on a multilumen locking connector. Each lumen of the multilumen connector engages one of the engagement ports at the rear of the housing of the needle holder. Each of the needles on the needle holder is in communication with an inlet opening at the rear of the housing. Thus, upon connection to a multilumen catheter each needle is in communication with one of the lumens of that catheter.

In accordance with the multiple channel subcutaneous infusion port of the present invention, the infusion port provides a plurality of isolated chambers. A penetrable septum overlies the isolated chambers. A multilumen catheter is connected to the infusion port and extends therefrom. Each lumen of the multilumen catheter is connected to a different one of the isolated chambers by a chamber access tube. Each isolated chamber is adjacent the inner surface of the septum such that a plurality of needles aligned in parallel can be inserted through the septum, each needle entering a different one of said isolated chambers.

It is an object of the present invention to provide a single implantable port which can be used in the injection of a plurality of fluid solutions. It is a further advantage of the present invention that it keeps each of the plurality of fluids solutions being injected into the port isolated from one another until the fluid reaches the blood stream. The present invention advantageously provides for infusion of a plurality of fluids into an implanted infusion port through the use of a single catheter and needle holding device.

Other objects and advantages of the invention will become apparent during the following description of the presently preferred embodiments of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view in partial cross-section of the needle holder and infusion port of the present invention as they would appear in use on a patient.

FIG. 2 is a top view of the multiple channel subcutaneous infusion port of the present invention.

FIG. 3 is a side view of the infusion port of FIG. 2.

FIG. 4 is a cross-sectional view of the needle holder of the present invention and a multilumen locking connector.

FIG. 5 is a rear plan view of the needle holder of the FIG. 4.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, FIG. 1 shows a multiple channel needle holder 10 with its needles 12 inserted into a multiple channel subcutaneous infusion port 20. The infusion port 20 is implanted within the layer of fatty tissue 23 underneath the skin surface 21. Sutures 22 hold the infusion port to the muscle wall 25 beneath the fatty tissue. The sutures 22 are applied through slots 24 distributed around the edge portion of a base 26 of the infusion port 20. The needles 12 penetrate septum 28 at the top portion of the infusion port and extend through into a plurality of isolated chambers 30. The drawings show a needle holder and multichannel infusion port with four needles and isolated chambers respectively, however, it should be understood that the invention is not limited to any specific number of needles or chambers.

The needle holder 10 is shown attached to a multilumen catheter 40 by a multilumen locking connector 50. A multilumen locking connector which may be used in conjunction with the needle holder of the present invention is described in allowed U.S. patent application Ser. No. 678, 481, filed Dec. 5, 1984 which will issue as U.S. Pat. No. 4,581,012 on Apr. 8, 1986 and sharing the same Assignee as the present invention. The disclosure of said patent is hereby incorporated by reference herein. As shown in FIG. 1, the locking connector 50 includes a locking ring 52 which engages a flange 14 on the outside of the housing of the needle holder 10. FIG. 1 shows the locking ring 52 prior to engagement with the flange 14.

In operation, individual fluid solutions are passed through each lumen of the multilumen catheter 40 into the needle holder 10 where they are injected through the needles 12 into the isolated chambers 30 of the infusion port 20. The fluids continue out of the infusion port 20 through a subcutaneous multilumen catheter 60. Each fluid solution thus remains isolated from each of the other fluid solutions until it reaches the blood stream at the end of the catheter 60.

Referring now to FIGS. 2 and 3, the multichamber subcutaneous infusion port is discussed in greater detail. The housing of the port includes a housing wall 32 resting upon the base 26 of the port. Located within the housing are sealing walls 34 which isolate each chamber 30 from one another and a septum 28 which overlies the sealing walls 34 to enclose the chambers 30. A silicon gasket may be placed between sealing walls 34 and base 26 to aid in sealing the chambers. The housing wall 32, base 26 and sealing walls 34 are preferably made out of stainless steel. The inner face of the septum 28 is adjacent the chambers 30 and is on the opposite side of the septum from an outer face which is exposed through the top of the housing. The septum 28 is made of a penetrable self sealing material, typically silicone. A multilumen catheter 60 is connected to the infusion port 20 through a hole in the housing. Each lumen of the multilumen catheter is in communication with a chamber access tube 36. There is a chamber access tube 36 for each lumen. Each chamber access tube 36 is in communication with a different one of the isolated chambers 30 for conducting fluid out its respective chamber. In the preferred embodiment shown, the hole in the housing is adjacent two chambers 30. The access tubes 36 for these chambers feed immediately into the multilumen catheter 60. A conduit 37 through a sealing wall 34 provides space for the two other access tubes 36 which extend into their respective chamber 30 near the center of the infusion port 20.

In the preferred embodiment, press fit assembly pins 38 hold the housing wall 32 to the base 50. The top portion of the housing 32 holds the septum 28 in place over the sealing walls 34. The top portion of the housing can be shaped as the sealing walls 34 to provide solid portions over the sealing walls and openings superimposed over said chambers so that a needle injected into the septum 28 will be inserted into a chamber 30 rather than a sealing wall 34. Slots 24 are provided about the periphery of the base 50. Sutures may be applied through the slots to hold the infusion port in place within the patients body.

The needle holder 10 of the present invention shall now be described with reference to FIGS. 4 and 5. The needle holder 10 of FIG. 4 is shown with curved needles 12. The needle holder is made with a housing 11, preferably made from plastic. Curved needles are an alternative to the straight needles shown in FIG. 1. Curved needles advantageously hold more securely onto an infusion port. The needles 12 are secured within the housing 11 by a conventional bonding technique, such as gluing or potting. The insertion end of the needles extend out from the front face of the housing 11. The needles 12 are in fluid communication with the inlet openings 18 at the rear face of the housing 11. Each of the openings 18 is located within an engagement port 16. In the embodiment shown the engagement port 16 are female connectors for engagement with the male connectors of a multilumen catheter connector 50. It would be equally possible to interchange this arrangement and provide male engagement ports 16 on the needle holder 10 and female connectors on the multilumen catheter connector 50. A flange 14 extends from the needle holder 10 for engaging the multilumen locking connector 50. As shown in FIG. 4, the multilumen locking connector 50 includes a locking ring 52 which has a threaded interior. The threaded interior engages the flange 14 and allows the connector to be screwed tightly onto the needle holder. The combination of multilumen catheter 40, multilumen catheter connector 50 and needle holder 10 provide four individual passageways for four separate fluid solutions.

The needle holder may be changed so that the front face and rear face of the needle holder housing are perpendicular to each other. This would advantageously allow the external catheter 40 to lie flat against a patient's body when the needle holder 10 is inserted into the infusion port 10.

Of course, it should be understood that various other changes and modifications to the preferred embodiments described above will be apparent to those skilled in the art. For example, the subcutaneous catheter can be connected to the infusion port through the base instead of the housing. This and other changes can be made without departing from the spirit and the scope of the invention and without diminishing its attendent advantages. It is therefore intended that such changes and modifications be covered by the following claims:
Assignee/Applicant: I Flow Corporation,Torrance,CA,US
Assignee/Applicant First: I Flow Corporation,Torrance,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Torrance,CA,US
Assignee Count: 1
Inventor: Brown, Eric W.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W.
Inventor - w/address: Brown Eric W.,Redondo Beach,CA,US
Inventor Count: 1
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Pellegrino, Stephen C.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1987-09-22
Publication Month: 09
Publication Year: 1987
Application Number: US1986849408A
Application Country: US
Application Date: 1986-04-08
Application Month: 04
Application Year: 1986
Application with US Provisional: US1986849408A | 1986-04-08
Priority Number: US1986849408A
Priority Country: US
Priority Date: 1986-04-08
Priority Date - Earliest: 1986-04-08
Priority Month: 04
Priority Year(s): 1986
Earliest Priority Year: 1986
Related Application Table:
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M000500, A61M003700, A61M003902, A61M003910
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M000500
A
A61
A61M
A61M0005
A61M000500
A61M003700
A
A61
A61M
A61M0037
A61M003700
A61M003902
A
A61
A61M
A61M0039
A61M003902
A61M003910
A
A61
A61M
A61M0039
A61M003910
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current

A61M 39/0208
A61M 39/10


A61M 2039/0211
A61M 2039/1072

20130101
20130101

EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604173, 604175, 604244, 604539, 604283
US Class (divided): 604/173, 604/175, 604/244, 604/539, 604/283
US Class - Main: 604173
US Class - Original: 604173 | 604175 | 604283 | 604244
ECLA: A61M003902B, A61M003910, K61M003902B2, K61M003910V
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent: Cormeditations, Sep. 1985, Issue No. 8. | Port-A-Cath, "Totally Implantable Drug Delivery System", (Advertisement). | MediPort, "Totally Implanted Vascular Access Device", Copyrighted 1983.
Count of Cited Refs - Non-patent: 3
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US4548607A
1985-10-22
Harris Donald L.
CORDIS CORP
-
0 (Examiner)
Title: Implantable manually actuated medication dispensing system
US3682087A
1972-08-08
Panek Mitchell W.
MITCHELL W PANEK
-
0 (Examiner)
Title: INJECTOR DEVICE
US4400169A
1983-08-23
Stephen Robert L.
UNIV UTAH RES FOUND
-
0 (Examiner)
Title: Subcutaneous peritoneal injection catheter
US4193397A
1980-03-18
Tucker Elton M.
METAL BELLOWS CO
-
0 (Examiner)
Title: Infusion apparatus and method
US4490137A
1984-12-25
Moukheibir Nabil W.
MOUKHEIBIR NABIL W
-
0 (Examiner)
Title: Surgically implantable peritoneal dialysis apparatus
US3964482A
1976-06-22
Gerstel Martin S.
ALZA CORP
-
0 (Examiner)
Title: Drug delivery device
US4581012A
1986-04-08
Brown Eric W.
I FLOW CORP
-
0 (Examiner)
Title: Multilumencatheter set
US4496350A
1985-01-29
Cosentino Louis C.
RENAL SYSTEMS
-
0 (Examiner)
Title: Blood access device
US4417888A
1983-11-29
Cosentino Louis C.
RENAL SYSTEMS
-
0 (Examiner)
Title: Percutaneous implant
US3640269A
1972-02-08
Delgado Jose M. R.
JOSE M R DELGADO
-
0 (Examiner)
Title: FLUID-CONDUCTING INSTRUMENT INSERTABLE IN LIVING ORGANISMS
US3572336A
1971-03-23
HERSHBERG DANIEL R
DANIEL R HERSHBERG
-
0 (Examiner)
Title: SYRINGE
US4557722A
1985-12-10
Harris Donald L.
CORDIS CORP
-
0 (Examiner)
Title: Fill port for an implantable dispensing system
US4543088A
1985-09-24
Bootman Matthew W.
AMERICAN HOSPITAL SUPPLY CORP
-
0 (Examiner)
Title: Self-sealing subcutaneous injection site
US3949746A
1976-04-13
Wallach Mark
ANIMAL SYSTEMS INC
-
0 (Examiner)
Title: Animal injector apparatus
US3783868A
1974-01-08
Bokros Jack C.
GULF OIL CORP
-
0 (Examiner)
Title: PERCUTANEOUS IMPLANT
Count of Cited Refs - Patent: 15
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1988-12-13
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1989-12-12
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1990-08-21
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MICHIGAN TRANSTECH CORP
US5556381A
1996-09-17
MICHIGAN TRANSTECH CORP
US5607393A
1997-03-04
MICHIGAN TRANSTECH CORP
US5643308A
1997-07-01
MARKMAN; BARRY STEPHEN
US5702384A
1997-12-30
OLYMPUS OPTICAL CO
US5713859A
1998-02-03
VASCA INC
US5755780A
1998-05-26
VASCA INC
US5792104A
1998-08-11
MEDTRONIC INC
US5792123A
1998-08-11
MICHIGAN TRANSTECH CORP
US5807356A
1998-09-15
VASCA INC
US5833654A
1998-11-10
BARD INC C R
US5868758A
1999-02-09
MARKMAN; BARRY S
US5931801A
1999-08-03
VASCA INC
US6042569A
2000-03-28
VASCA INC
US6053901A
2000-04-25
VASCA INC
US6056717A
2000-05-02
VASCA INC
US6086555A
2000-07-11
BARD INC C R
US6210366B1
2001-04-03
SANFILIPPO II DOMINIC JOSEPH
US6398764B1
2002-06-04
VASCA INC
US6537242B1
2003-03-25
BECTON DICKINSON CO
US6565525B1
2003-05-20
VASCA INC
US6726660B2
2004-04-27
BIOTAP AS
US6764472B1
2004-07-20
BARD ACCESS SYSTEMS INC
US7108686B2
2006-09-19
BARD ACCESS SYSTEMS INC
US7588552B2
2009-09-15
NANO PASS TECHNOLOGIES LTD
US7785302B2
2010-08-31
BARD INC C R
US7896837B2
2011-03-01
BECTON DICKINSON CO
US7947022B2
2011-05-24
BARD INC C R
US7959615B2
2011-06-14
BARD INC C R
US7984929B2
2011-07-26
RENISHAW PLC
US8021324B2
2011-09-20
MEDICAL COMPONENTS INC
US8025639B2
2011-09-27
BARD INC C R
US8029482B2
2011-10-04
BARD INC C R
US8177762B2
2012-05-15
BEASLEY JIM C
US8202259B2
2012-06-19
EVANS JOHN G
US8257325B2
2012-09-04
SCHWEIKERT TIMOTHY M
US8382723B2
2013-02-26
BARD INC C R
US8382724B2
2013-02-26
BARD INC C R
US8475417B2
2013-07-02
POWERS KELLY B
US8545460B2
2013-10-01
BEASLEY JIM C
US8585663B2
2013-11-19
BARD INC C R
US8603052B2
2013-12-10
BARD INC C R
US8608712B2
2013-12-17
BIZUP RAYMOND
US8608713B2
2013-12-17
BEASLEY JIM C
US8641676B2
2014-02-04
BUTTS DAVID M
US8641688B2
2014-02-04
BARD INC C R
US8690795B2
2014-04-08
DAHLSTRAND CHRISTER
US8715244B2
2014-05-06
PRECHTEL ERICKA
US8747371B2
2014-06-10
STREATFIELD GILL STEVEN
US8805478B2
2014-08-12
POWERS KELLY B
US8845549B2
2014-09-30
FREEMAN DOMINIQUE
US8845550B2
2014-09-30
SANOFI AVENTIS DEUTSCHLAND
US8852160B2
2014-10-07
SCHWEIKERT TIMOTHY M
US8905945B2
2014-12-09
FREEMAN DOMINIQUE M
US8932271B2
2015-01-13
HAMATAKE BRET
US8939947B2
2015-01-27
BARD INC C R
US8945910B2
2015-02-03
MARSOT TRAVIS
US8965476B2
2015-02-24
FREEMAN DOMINIQUE M
US8974422B2
2015-03-10
STREATFIELD GILL STEVEN
US8998860B2
2015-04-07
SHEETZ KEVIN W
USD416623S1
1999-11-16
Incutech Inc.
USD676955S1
2013-02-26
BARD INC C R
USD682416S1
2013-05-14
TREBELLA MATTHEW R
WO1998031417A2
1998-07-23
BARD INC C R
WO1999042166A1
1999-08-26
BARD INC C R
WO2007140381A2
2007-12-06
KIM STANLEY
WO2008062173A1
2008-05-29
RENISHAW PLC
WO2012099846A1
2012-07-26
NAVILYST MEDICAL INC
WO2012135805A2
2012-10-04
MODERNA THERAPEUTICS
WO2013117662A1
2013-08-15
RENISHAW IRELAND LTD
Count of Citing Patents: 101
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
1999-11-30
FP
-
Description: EXPIRED DUE TO FAILURE TO PAY MAINTENANCE FEE 1999-09-22
1999-09-19
LAPS
-
Description: LAPSE FOR FAILURE TO PAY MAINTENANCE FEES
1999-04-13
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1995-03-06
FPAY
+
Description: FEE PAYMENT
1990-12-17
FPAY
+
Description: FEE PAYMENT
1986-04-08
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION 3302 SEPULVEDA BLVD. SUITE D, T ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNOR:BROWN, ERIC W.; REEL/FRAME:004551/0845 1986-04-01
1986-04-08
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST; ASSIGNOR:BROWN, ERIC W.; REEL/FRAME:004551/0845 1986-04-01
Post-Issuance (US): EXPI Expiration 1999-09-22 1999 Sep. 22, 1999 due to failure to pay maintenance fees
Maintenance Status (US): E3
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
I-FLOW CORPORATION,TORRANCE,CA,US
BROWN, ERIC W.
1986-04-01
004551/0845
1986-04-08
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
License (EP) - License date:
EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4695273A
19870922
Brown Eric W.
I FLOW CORP
Title: Multiple needle holder and subcutaneous multiple channel infusion port
CA1264261A1
19900109
BROWN ERIC W
I FLOW CORP
Title: MULTIPLE NEEDLE HOLDER AND SUBCUTANOEUS MULTIPLE CHANNEL INFUSION PORT
EP241159A2
19871014
Brown Eric W.
I FLOW CORP
Title: Multiple needle holder and subcutaneous multiple channel infusion port
EP241159A3
19871202
Brown Eric W.
I-FLOW CORP
Title: Multiple needle holder and subcutaneous multiple channel infusion port
JP62240069A
19871020
ERITSUKU DABURIYU BURAUN
FUROO CORP I
Title: MULTINEEDLE HOLDER AND MULTIPLE FLOW CHANNEL TYPE INJECTION PORT APPARATUS
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4695273A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4695273A_&format=gif&fponly=1
Record Source: Result Set
Top
Record 9/43
US4687475AMethod for sequential intravenous infusion of multiple fluids
Publication Number: US4687475A  
Title: Method for sequential intravenous infusion of multiple fluids
Title (Original): Method for sequential intravenous infusion of multiple fluids
Title (English): Method for sequential intravenous infusion of multiple fluids
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Sequential intravenous solns. admin. method by sepg. two solns. in catheter by predetermined amt. of spacer soln.
Abstract:


A method of sequential intravenous infusion of a plurality of fluid solutions is disclosed in which a spacer solution is administered alternately with the fluid solutions to prevent the fluid solutions from substantially mixing with one another.
Abstract (English):

A method of sequential intravenous infusion of a plurality of fluid solutions is disclosed in which a spacer solution is administered alternately with the fluid solutions to prevent the fluid solutions from substantially mixing with one another.
Abstract (French):
Abstract (German):
Abstract (Original):

A method of sequential intravenous infusion of a plurality of fluid solutions is disclosed in which a spacer solution is administered alternately with the fluid solutions to prevent the fluid solutions from substantially mixing with one another.
Abstract (Spanish):
Claims:

We claim:
1. A method for sequential intravenous administration of a plurality of fluid solutions, said method comprising: *
providing a valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said plurality of solutions to different inputs of said valve; *
connecting a lumen of a catheter tube to the output of said valve; and *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said lumen of said catheter tube.
Claims Count: 1
Claims (English):

We claim:
1. A method for sequential intravenous administration of a plurality of fluid solutions, said method comprising: *
providing a valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said plurality of solutions to different inputs of said valve; *
connecting a lumen of a catheter tube to the output of said valve; and *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said lumen of said catheter tube.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A method for sequential intravenous administration of a plurality of fluid solutions, said method comprising: *
providing a valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said plurality of solutions to different inputs of said valve; *
connecting a lumen of a catheter tube to the output of said valve; and *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said lumen of said catheter tube.
Independent Claims:
1. A method for sequential intravenous administration of a plurality of fluid solutions, said method comprising: *
providing a valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said plurality of solutions to different inputs of said valve; *
connecting a lumen of a catheter tube to the output of said valve; and *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said lumen of said catheter tube.
Description:

BACKGROUND OF THE INVENTION

This invention relates to the intravenous admininstration of multiple fluids.

There are many medical applications for which an intravenous infusion for a multiplicity of fluid solutions can be beneficial. One such application is chemotherapy infusions used in cancer treatment. This was recognized in the recent 13th Annual Cancer Course, given Mar. 1-3, 1984, by the Harvard Medical School and New England Deaconess Hospital. In the syllabus article entitled "Multi-Drug Infusion Chemotherapy: the Delivery of Two or More Drugs Simultaneously", Dr. Jacob J. Lokich described techniques for mixing drug solutions to form a combination which can be delivered to a patient by continuous intravenous infusion. The use of combination multi-drug chemotherapy has been developing in medicine since the 1960's. It has been used for such diseases as acute leukemia, Hodgkins disease, lung cancer, breast cancer and ovarian cancer. Unfortunately, there are only a limited number of drug combinations which have been found to be compatible and stable and which can produce a synergistic effect when administered.

There are many drugs which may not be used simultaneously because of reactions between the drugs which make infusion impracticable or undesirable. Some drugs react and thereby neutralize one another. Other drugs react to form precipitates which may clog the catheter tubing or even worse cause an embolism in the patient. Thus, according to present multi-drug combination treatments, physicians are limited in their choice of drug solutions.

SUMMARY OF THE INVENTION

This invention is directed to a method for sequential intravenous administration of fluid solutions. The method provides for administering a first fluid solution through a catheter tube followed by the contiguous administration of a predetermined amount of spacer solution. The spacer solution is then contiguously followed by a second fluid solution. Apparatus is provided for electronically changing the solution being provided from one to another. The amount of spacer solution which would be used between fluid solutions would be prescribed by the physician and should be large enough to prevent the first and second fluid solutions from substantially mixing.

The method of the present invention enormously increases the number of variations available to physicians for treating cancer and other diseases with multiple drug infusions. Since the intravenous spacer solution prevents the drug solutions from substantially mixing with one another before entering the body, drug solutions which were formerly incompatible because of deleterious reactions may now be tried as potentially beneficial treatments. Once a drug solution is infused into the patient the blood stream carries the drug away so quickly that it is usually safe to follow the drug solution with another solution after the spacer. By sequentially alternating between drug solutions and spacer solutions many new multiple drug treatments may be developed.

Other objects and advantages of the invention will become apparent during the following description of the presently preferred embodiments of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of an apparatus for performing the method of the present invention.

FIG. 2 is a sectional view of the catheter tube of FIG. 1 demonstrating the method of the present invention.

FIG. 3 is a cross-sectional view of the catheter tube of FIG. 1 after the spacer solution has been pumped through a length of catheter tubing.

FIG. 4 is an elevational view of a peristaltic pump for use in the method of the present invention.

FIG. 5 is an elevational view of a syringe-type cartridge pump for use in the method of the present invention.

FIG. 6 is a cross-sectional view of a valve of the present invention.

FIG. 7 is a sectional view taken along lines 3--3 of the valve in FIG. 6.

FIG. 8 is another elevational view of the apparatus of FIG. 1.

FIG. 9 is a sectional view of the apparatus of FIG. 8 taken along lines 5--5.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, FIG. 1 illustrates an apparatus for performing the method of the present invention. The apparatus is described in the inventors' copending application U.S. Ser. No. 619,847 entitled "Apparatus and Method for Administering Multiple Fluid Infusions", sharing the same filing date and assignee as the present invention. The inventors' copending application is hereby incorporated by reference herein. Their apparatus enables one to switch between different fluid solutions being intravenously administered through a catheter tube without allowing any air bubbles to enter into the line. A valve 110 receives inputs from a plurality of fluid solution sources and has a primary input for a spacer solution 10 source. The valve 110 switches between sources to alternately provide one of the fluid solutions and the spacer solution 10.

The valve 110 is mounted on control apparatus 120. The valve 110 is shown receiving four inputs from intravenous fluid solution sources. The valve 110 includes rotary core member 112. The rotary core member 112 has an output passageway 114 which is connected to a catheter tube 20 for delivering fluid to a patient. A pump 140 is coupled to the catheter tube for delivering the fluid at a predetermined speed. The pump 140 which is used with the present invention may be any conventional type of infusion pump. The presently preferred embodiment uses a peristaltic pump 30 which is especially well-suited for long duration infusions. The use of a syringe-type cartridge pump 40 is allowable for situations where a higher pressure is required and where larger fluid volumes may be infused into the patient.

Control apparatus 120 has a control panel 22 by which an operator can program the control apparatus 120 to infuse predetermined amounts of each fluid solution into the patient through the catheter tube 20. An operator would indicate to the apparatus 120 the quantity of each fluid to be pumped per unit time through the catheter tube. The apparatus 120 then computes the required pump speed and displays this information to the operator. The operator sets the pump 140 at this speed. The programmed apparatus automatically switches the valve 110 between fluid solutions to administer the prescribed regimen.

One of the inputs into the valve 110 is a neutral solution which is used as an isolator between drug solutions thereby preventing any substantial premixing of the solutions in the catheter tube 20. The control apparatus 120 will always alternate between the neutral solution and one of the drug solutions. This is the method of the present invention described below after the description of the apparatus.

It is highly important that the infused fluid solutions are not contaminated. Therefore, it is important that the valve 110 be sterile. The presently preferred embodiment employs a disposable plastic valve 110 which can withstand a conventional sterilization process.

The apparatus of the present invention individually connects a fluid solution through an input site 18 in the valve 110 with an output passageway 114 through the rotary core member 112 of the valve 110. The output passageway 114 is directly connected with the catheter tube 20. During the time interval in which the rotary core member 112 is turned to switch the connection from one solution to another, there is an instant in which both the input site 18 and the conduit 50 are exposed to the output passageway 114. Then there is an interval in which solely the neutral solution is pumped from conduit 50 through the catheter tube 20. Thus, the flow of fluid into the catheter tube 20 is continuous and is never interrupted. As the rotary core member 112 is turned to switch from conduit 50 to an input site 18, the flow of fluid into the catheter tube 20 is similarly continuous and never interrupted.

Referring now to FIGS. 6 and 7, the valve of the present invention may be described in greater detail. The valve 110 is supported in a hollow cylindrical housing 116. The housing 116 is mountable on the apparatus 120 by its mounting holes 15 and a lip 24. At the top of the valve 110, lip 24 extends outward so as to fit under ridge 25 which extends from control apparatus 120. Pins 23 projecting out of the control apparatus 120 snap into the mounting holes 15. Any conventional mounting means may be substituted for the mounting holes 15 and lip 24 as long as the valve 110 can be securely held in place and may be easily dismounted for replacement with a new sterile valve 110.

The housing 116 includes a plurality of input sites. In the preferred embodiment, there is one primary site 17 and a plurality of secondary sites 18. Each input site is a hole through the circumference of the hollow housing 116. The input site accommodates a hollow cylindrical shaft. In the case of the secondary input sites, the hollow cylindrical shafts 19 extend through the hollow housing 116 and into contact with sealing means surrounding the rotary core member 112. In the preferred embodiment, it is the circumference 13 of the rotary core member 112 which contacts and seals the cylindrical shafts 19. The ends of the shafts 19 are ground with a curve matching that of the circumference 13 of the rotary core member 112 so that the shafts lie flush against the circumference 13 to effectuate a seal. It would be possible however to provide a washer type device about the rotary core member to function as the sealing means.

The output passageway 114 extends through rotary core member 112 from an access hole 11 in the circumference 13. When the access hole is not aligned with a secondary input site 18, that input site 18 will be sealed closed by the circumference 13. The primary input site 117 has a shaft 21 which does not extend to the sealing means on the rotary core member 112. Thus, access is always maintained between the primary input site 17 and a conduit 50 which surrounds the rotary core member 112. In the presently preferred embodiment, the conduit 50 is formed by the rotary core member 112 itself. The rotary core member 112 is spool-shaped to form the channel-like conduit 50 about its circumference. The conduit 50 is formed with circumference 13 as the floor and sidewalls extending from the planar surface ends of the core member 112. The conduit 50 is wider than the outer circumference of the hollow cylindrical shafts 19. Thus, as shown in FIG. 7, the conduit 50 extends around each of the secondary input sites. This enables the neutral solution which is fed through the primary input site 17 to fill the conduit 50 all the way around the rotary core member 112.

The conduit 50 simplifies the sequential switching operation of valve 110. Since treatments involve a plurality of drugs, it is desirable to avoid substantial mixing of the drugs in the catheter tube 20. To accomplish this, the neutral solution is accessed after each use of a drug solution. The conduit 50 provides access to the neutral solution between adjacent secondary input sites 18. Thus, the core member 112 can rotate directly from one solution to another and still access neutral solution in between. This construction also promotes protection against air bubbles in the line. The access hole 11 is made wider than the walls of the hollow shafts 19 so that fluid can be continuously pulled through the catheter tube 20. As the access hole 11 is moved out of direct alignment with a secondary input site 18, it will be instantaneously exposed to solution from the input site 18 and from the conduit 50. Then it will allow passage solely of the neutral solution from the conduit 50. Thus, there will be a continuous flow of fluid which will prevent air bubbles from ever forming within the system.

At the external end of each hollow cylindrical shaft 19, there is a male luer connector for mating with a female luer connector on the polymer catheter tube bringing fluid from the intravenous fluid solution source. Any conventional connecting means may be substituted for the present male-female luer connection.

The conduit 50 carrying the neutral solution must be sealed to prevent leakage. In the presently preferred embodiment, a double seal is provided by the rotary core member 112 against the hollow cylindrical housing 116. The outer planar surfaces of the rotary core member 112 frictionally engage an inner wall of a channel 26 within the inner circumference of the hollow cylindrical housing 116. The outermost circumference of the sidewalls of the rotary core member 112 frictionally engages the floor of the channel 26 in the hollow housing 116. The snug fit of the rotary core member within the hollow housing thus functions to seal the conduit 50.

The output passageway 114 is shown in FIGS. 6 and 7. It extends from the access hole 11 in the circumference 13 of the rotary core member 112 to an output site projecting from one of the planar surfaces of the core. A catheter tube 20 makes connection with the outer projection from the core 112 to provide a path for the fluid to follow. Automatic mechanical rotation of the valve 110 is made possible by the connection of a gear 60 to the rotary core member 112. The teeth of the gear 60 mesh with the teeth of a gear 80 within the control apparatus 120 so that a motor 70 within the control apparatus may control the operation of the valve 110. The engagement of the two gears further contributes to holding the valve 110 in its mounted position on the control apparatus 120.

Referring now to FIGS. 8 and 9, the mechanics of the control apparatus 120 may be explained. A stepping motor 70 rotates a pulley 72. The pulley 72 is connected by a belt 74 to a pulley 76 on a speed reducer 78. The belt 74 thus drives the speed reducer 78. The speed reducer 78 transmits torque from the motor 70 to a gear 80 which is enmeshed with the gear 60 on the valve 110. In the presently preferred embodiment, the speed reducer uses a ratio of 48 to 1. In reducing the speed, the speed reducer 78 effectively increases the torque which is applied to the gear 60 on the valve 110. The increased torque enables the rotary core member 112 to turn against the friction from the hollow housing. Any conventional means of speed reduction may be substituted for the present drive train.

The stepping motor 70 is controlled by a microprocessor located on a circuit board 90 at the rear of the control apparatus 120. Power for the microprocessor circuitry and the motor 70 is provided from a line cord 92 which is connected through a power supply 94. It is preferable to include a backup battery supply which would be automatically switched on should the power supplied over the line cord 92 be disrupted. The microprocessor circuitry also receives inputs from the control panel 22. The control panel 22 is used to program the microprocessor so that one control apparatus 120 may be used to operate the valve 110 for administering an unlimited variety of prescribed regimens.

The apparatus of the invention makes possible the administration of advanced treatments using a plurality of drug solutions. The use of a greater variety of drug solutions is possible since the apparatus allows the use of a neutral solution as a spacer to prevent substantial mixing of the drug solutions in the catheter tube 20. The operation of the apparatus begins with mounting the valve 110 on the control apparatus 120. The fluid solutions are connected to the input sites 18 of the valve 110. A pump 140 is coupled to the catheter tube 20. The pump 140 is turned on and the catheter set is purged of air. The operator causes the valve 110 to turn through each input site position by pressing an appropriate button on the control panel 22. The controls and microprocessor means for implementing the controls may be provided by one skilled in the art. The operator leaves the valve 110 in each input site position until all air bubbles have been removed. The pump is then turned off.

The apparatus may now be initialized. The microprocessor memory is cleared. The volume of the neutral solution source is entered. The volume of the spacer size which is prescribed for use between the fluid solutions is entered. Then the volume of the other fluid solution sources and their prescribed rates of infusion are entered. The pumping rate or speed of pump 140 and the total volume of fluid to be infused per unit time are computed automatically and displayed to the operator on a display 26. The operator then instructs pump 140 to infuse at this speed and for this total volume. After the information has been fed into the microprocessor, thereby programming the apparatus to administer the prescribed regimen, the intravascular access needle on the catheter tube 20 is inserted into the patient and the pump 140 and control apparatus 120 are started.

The infusion process then proceeds automatically. The control apparatus 120 may be provided with an alarm that would sound after a calculated time period elapses which indicates that a solution is in need of refilling. A nurse would stop the pump and press a pause button on the control panel 22. The fluid source would be replaced or refilled. The line is purged if necessary. The new volume of fluid is entered into the control panel 22. Any necessary changes may be made to other variables entered into the apparatus. Then the pump 140 and control apparatus 120 may be restarted.

The apparatus of the present invention only requires a single pump and catheter tube to deliver all of the fluid solutions to the patient. The control panel can be programmed to set the amounts of fluid solutions to be provided to the patient, thereby satisfying a physician's particularly prescribed regimen. The valve of the invention is designed to effectively seal each of the drug solutions from one another so that no undesirable precipitates or reactions occur prior to the infusion. This invention thereby advantageously expands the number of drug solutions available to physicians for use in multiple drug infusion treatments. The neutral solution may be easily accessed between the input sites of the other fluid solutions to provide a spacer between the solutions in the catheter tube 20.

The valve assembly is made of a plastic that may be sterilized by a conventional method. It may be easily mounted and dismounted from the control apparatus so that it may be replaced by a new, sterile valve as needed. The disposability of the valve enhances the integrity of the sterility of the infusion system. The apparatus of the present invention has thus made possible a new and simplified method for administering a number of drug solutions to a patient through a single catheter tube attached to a single pump, without substantially mixing the drugs in the catheter tube.

According to the method of the present invention, the spacer solution 10 is provided for substantially isolating the different fluid solutions during intravenous administration. FIG. 2 shows a first solution 12 and a second solution 14 separated by the spacer solution 10. The solutions are carried by a catheter tube 20 through a needle and into a patient. Pump 140 keeps the fluids moving through the catheter tube 20 at a predetermined rate. The spacer solution 10 must be a solution which is suitable for intravenous infusion into a patient. The spacer 10 must also be neutral with respect to each of the fluid solutions on either side of it. In other words, the spacer solution 10 must not substantially react with either the first fluid solution 12 or the second fluid solution 14 while it is traveling through the catheter tube 20 into the patient. Some solutions may react with one another over a long period of time, however, it is only necessary that there be no adverse reactions prior to the infusion.

There are a number of intravenous solutions which may be selected as the neutral spacer 10, including but not limited to saline solutions, dextrose solutions and intravenous lipid solutions. The appropriate spacer solution 10 should be selected according to a patient's needs. For example, a patient requiring nutritional supplement may receive a high concentration dextrose solution as the spacer, whereas a patient merely requiring liquids may receive a saline solution or a low concentration dextrose solution.

The volume of the spacer solution 10 affects the rate of mixing between the fluid solutions on adjoining sides of the spacer. A spacer with a low volume would have a tendency to allow the adjoining fluids to diffuse more quickly into each other. On the other hand, a spacer with a larger volume would decelerate the rate of diffusion of adjoining drug solutions into each other.

The volume of the spacer solution must be selected so as to avoid substantial mixing between the fluid solutions on either side of the spacer solution 10 in the time that the solutions are in transit within the catheter tube 20. If the diffusion rate between a fluid solution and the spacer solution 10 is rapid, the spacer solution 10 must have a greater volume to avoid mixing of the two isolated fluid solutions. Some insubstantial mixing may be allowed where the first drug solution 12 and the second drug solution 14 are relatively compatible with one another and will not react when in contact to a small extent. For more highly reactive fluid solutions, any amount of mixing would be substantial and must be prevented. Thus, the appropriate volume of spacer 10 depends on a variety of factors.

Because of laminar flow which occurs during the movement of fluids through the catheter tube 20, the type of pump being used will also be determinative of the minimum volume of spacer solution 10 required to separate the first and second fluid solutions. Referring now to FIG. 3, the affects of laminar flow of fluids as they travel through the catheter tube 20 is shown. There is friction between the walls of the catheter tube 20 and the fluids which are flowing through it. This friction slows the outer layers of fluid. Thus, the fastest flowing fluid is found along the center axis of the catheter tube 20. Over a period of travel through the tube the spacer solution 10 develops a convex pointed front side and a concave indented rear side. The volume of spacer solution 10 must be prescribed to be large enough so that the rear edge of the first fluid solution 12 does not substantially overlap the leading front point of fluid solution 14. A cross-section showing such an overlap is illustrated in FIG. 3 at cross-section 16. A peristaltic pump 30, illustrated in FIG. 4, operates by squeezing the catheter tube 20. If there is a cross-section 16 including the first and second fluid solutions as they reach the peristaltic pump 30, upon being squeezed by pump 30 the two solutions would be in direct contact as a result of the pump action. Therefore, it is important that when using a peristaltic pump 30 that there be a cross-section 17 maximally filled with spacer solution 10 as the spacer solution reaches the peristaltic pump 30.

A syringe-type cartridge pump 40, also known as volumetric pump, illustrated in FIG. 5 works in a different manner. The cartridge pump 40 operates by filling and emptying a chamber 42. A valve 44 rotates to switch between a filling and an emptying position. To prevent substantial mixing between fluid solution 12 and second fluid solution 14, it is again necessary to prescribe a sufficient volume of spacer solution 10 to substantially isolate the two fluid solutions. To accomplish this, the spacer solution 10 should encompass a volume which fills a cylindrical cross-section 19 of the tube which is equal to or greater than the volume of the chamber 42. Thus, the pump chamber 42 will be prevented from substantially filling with more than one of the fluid solutions separated by the spacer 10.

The treatment variations made possible by the method of the present invention are numerous. Various drugs, nutrients, electrolytes or other items capable of being delivered in fluid solutions may be sequentially infused into a patient according to the present invention. The number of fluid solutions which may be sequentially infused into a patient are only limited by the ability to connect the solutions by valves to a catheter tube in a manner which continuously administers fluids without allowing any air bubbles into the line. The compatibility and stability of the various fluid solutions with one another are now of less importance. Almost any drug solution which can produce synergistic effects when used in combination, may be infused according to the method of the present invention. By frequently alternating between fluid solutions and spacer, several drug solutions can be administered to a patient in sequence over and over again without the problem of substantial mixing prior to infusion. The patient is thus able to obtain many benefits which may derive from the combination of a plurality of drug solutions. Many new drug solution combinations will be made possible through the use of the present invention.

Of course, it should be understood that various changes and modifications to the preferred embodiments described above will be apparent to those skilled in the art. Any intravenous solution which does not react with adjoining fluid solutions may be substituted for the saline, dextrose and lipid solutions of the present invention. These and other changes can be made without departing from the spirit and the scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Torrance,CA,US
Assignee/Applicant First: I Flow Corporation,Torrance,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Torrance,CA,US
Assignee Count: 1
Inventor: Tai, Henry T. | Brown, Eric W.
Inventor First: Tai, Henry T.
Inventor - Original: Tai, Henry T. | Brown, Eric W.
Inventor - w/address: Tai Henry T.,Pacific Palisades,CA,US | Brown Eric W.,Redondo Beach,CA,US
Inventor Count: 2
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Rosenbaum, C. Fred / Vinyard, Sherri E.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1987-08-18
Publication Month: 08
Publication Year: 1987
Application Number: US1986849106A
Application Country: US
Application Date: 1986-04-07
Application Month: 04
Application Year: 1986
Application with US Provisional: US1986849106A | 1986-04-07
Priority Number: US1984619846A
Priority Country: US
Priority Date: 1984-06-12
Priority Date - Earliest: 1984-06-12
Priority Month: 06
Priority Year(s): 1984
Earliest Priority Year: 1984
Related Application Table:
Parent/ChildApplication NumberApplication DatePublication NumberPublication DateType of RelationshipStatus
P
US1984619846A
1984-06-12
-
-
Continuation
Abandoned
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M0005142, A61M0005168
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M0005142
A
A61
A61M
A61M0005
A61M0005142
A61M0005168
A
A61
A61M
A61M0005
A61M0005168
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current
Current

A61M 5/16827
A61M 5/142

-


20130101
20130101

EP
EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604248, 604081
US Class (divided): 604/248, 604/081
US Class - Main: 604248
US Class - Original: 604248 | 604081
ECLA: A61M0005142, A61M0005168A11
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent: Hickman® and Broviac® Vascular Access Catheters Instructions for Use Evermed, Inc. Revised 1985. | Gray et al., "Multiple Use of TPN Catheter is Not Heresy: Retrospective Review and Initial Report of Prospective Study", Nutritional Support Services, vol. 2, No. 9, pp. 18-21, Sep. 1982. | Hutchinson, Margaret M., "Administration of Fat Emulsions", American Journal of Nursing, Feb. 1982.
Count of Cited Refs - Non-patent: 3
Cited Refs - Patent Table:
Publication NumberPublication DateInventorAssignee/ApplicantRelevanceSource
US4324238A
1982-04-13
Genese Joseph N.
ABBOTT LAB
-
0 (Examiner)
Title: Equipment sets having a combined air barrier and liquid sequencing device for the sequential administration of medical liquids at dual flow rates
US4256103A
1981-03-17
Mylrea Kenneth C.
PAXINOS JAMES
-
0 (Examiner)
Title: Automatic sequential fluid flow apparatus
US3957082A
1976-05-18
Fuson Robert Lee
ARBROOK INC
-
0 (Examiner)
Title: Six-way stopcock
US4094318A
1978-06-13
Burke George K.
BURRON MEDICAL PROD INC
-
0 (Examiner)
Title: Electronic control means for a plurality of intravenous infusion sets
US4512764A
1985-04-23
Wunsch Richard E.
WUNSCH RICHARD E
-
0 (Examiner)
Title: Manifold for controlling administration of multiple intravenous solutions and medications
US4258712A
1981-03-31
Harms Jack L.
ABBOTT LAB
-
0 (Examiner)
Title: Equipment sets having a pilot liquid controlled primary tube valve for the sequential administration of medical liquids at dual flow rates
US4333454A
1982-06-08
Hargest III Thomas S.
HARGEST III THOMAS S
-
0 (Examiner)
Title: Automatic tubular feeding apparatus and method
US4316460A
1982-02-23
Genese Joseph N.
ABBOTT LAB
-
0 (Examiner)
Title: Gravitational flow system for the sequential administration of medical liquids
US4450079A
1984-05-22
Farr Andrew F.
IMED CORP
-
0 (Examiner)
Title: Cassette for providing a controlled flow of fluid
US4391598A
1983-07-05
Thompson Thomas C.
QUEST MEDICAL INC
-
0 (Examiner)
Title: Intravenous drug additive delivery system with electronic control
US4265240A
1981-05-05
Jenkins Jon A.
IMED CORP
-
0 (Examiner)
Title: Apparatus for providing a controlled introduction of intravenous fluid to a patient
US4257416A
1981-03-24
Prager David
PRAGER DAVID
-
0 (Examiner)
Title: Multi-channel venipuncture infusion set
US4219022A
1980-08-26
Genese Joseph N.
ABBOTT LAB
-
0 (Examiner)
Title: Equipment sets for the sequential administration of medical liquids at dual flow rates having parallel secondary liquid flowpaths wherein one said path is controlled by a liquid sequencing valve
US4196730A
1980-04-08
Wilson Dennis R.
WILSON DENNIS R
-
0 (Examiner)
Title: Liquid drug dispenser
US4191183A
1980-03-04
Mendelson Barry
MENDELSON BARRY
-
0 (Examiner)
Title: Mixing chamber for use in plural medical liquid intravenous administration set
US3057350A
1962-10-09
COWLEY CALVIN C
BAXTER DON INC
-
0 (Examiner)
Title: Administration set
US4563175A
1986-01-07
LaFond Margaret
LAFOND MARGARET
-
0 (Examiner)
Title: Multiplesyringe pump
US4430074A
1984-02-07
Mooring William L.
DOUGLASS SAMUEL ERNEST
-
0 (Examiner)
Title: Method for the intravenous administration of plural solutions through a common flow monitoring station
Count of Cited Refs - Patent: 18
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
US4925444A
1990-05-15
BAXTER TRAVENOL LAB
US5104387A
1992-04-14
ST JUDE MEDICAL
US5207643A
1993-05-04
BALLARD MED PROD
US6423050B1
2002-07-23
TWARDOWSKI ZBYLUT J
US6511472B1
2003-01-28
MICROTHERAPEUTICS INC
US7520871B2
2009-04-21
LMA NORTH AMERICA INC
US7527608B2
2009-05-05
LMA NORTH AMERICA INC
Count of Citing Patents: 7
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
1999-10-26
FP
-
Description: EXPIRED DUE TO FAILURE TO PAY MAINTENANCE FEE 1999-08-18
1999-08-15
LAPS
-
Description: LAPSE FOR FAILURE TO PAY MAINTENANCE FEES
1999-03-09
REMI
-
Description: MAINTENANCE FEE REMINDER MAILED
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1995-02-21
FPAY
+
Description: FEE PAYMENT
1990-12-13
FPAY
+
Description: FEE PAYMENT
Post-Issuance (US): EXPI Expiration 1999-08-18 1999 Aug. 18, 1999 due to failure to pay maintenance fees
Maintenance Status (US): E3
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
Reassignment (US) Table - Latest:
Reassignment (US) - Assignee - LatestReassignment (US) - Assignor - LatestReassignment (US) - Date Signed - LatestReassignment (US) - Reel-Frame - LatestReassignment (US) - Date - Latest
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
Designated States:
Litigation (US):
Opposition (EP):
Opposition (EP) - Opponent:
Opposition (EP) - Date Filed:
Opposition (EP) - Attorney:
License (EP):
License (EP) - Licensee name:
License (EP) - License date:
EPO Procedural Status:
Gov't Interest (US):
Language of Publication: EN
INPADOC Family Table:
Publication NumberPublication DateInventorAssignee/Applicant
US4687475A
19870818
Tai Henry T.
I FLOW CORP
Title: Method for sequential intravenous infusion of multiple fluids
AU198544965A
19860110
BROWN ERIC W
I FLOW CORP
Title: METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS
EP182900A1
19860604
BROWN Eric W.
I FLOW CORP
Title: METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS
WO1986000022A1
19860103
BROWN Eric W.
I FLOW CORP
Title: METHOD OF SEQUENTIAL INTRAVENOUS INFUSION OF MULTIPLE FLUIDS
Front Page Drawing: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4687475A_&format=gif&fponly=0
Front Page Image: http://clips.thomsoninnovation.com/perl/clips/getclip.pl?size=360&patent=US4687475A_&format=gif&fponly=1
Record Source: Result Set
Top
Record 10/43
US4604093AApparatus and method for administering multiple fluid infusions
Publication Number: US4604093A  
Title: Apparatus and method for administering multiple fluid infusions
Title (Original): APPARATUS AND METHOD FOR ADMINISTERING MULTIPLE FLUID INFUSIONS
Title (English): APPARATUS AND METHOD FOR ADMINISTERING MULTIPLE FLUID INFUSIONS
Title (French):
Title (German):
Title (Spanish):
Title - DWPI: Valve connecting fluid sources to catheter is plastic with passage through core rotatable to align with selected inlets
Abstract:


A valve is disclosed which includes a hollow cylindrical housing having a plurality of input sites and a rotary core member having an output pasageway. The input sites which are not in communication with the output passageway are sealed. The valve may also include a primary input site connected to a conduit surrounding the rotary core member of the valve. The valve is demountable on a control apparatus for performing a method of administering a plurality of fluids intravenously to a patient. According to the method of the present invention, a neutral solution is provided in between each of the other different fluid solutions being infused into the patient. The control apparatus of the present invention may be programmed to automatically provide the patient with a prescribed amount of each fluid solution through the catheter tube.
Abstract (English):

A valve is disclosed which includes a hollow cylindrical housing having a plurality of input sites and a rotary core member having an output pasageway. The input sites which are not in communication with the output passageway are sealed. The valve may also include a primary input site connected to a conduit surrounding the rotary core member of the valve. The valve is demountable on a control apparatus for performing a method of administering a plurality of fluids intravenously to a patient. According to the method of the present invention, a neutral solution is provided in between each of the other different fluid solutions being infused into the patient. The control apparatus of the present invention may be programmed to automatically provide the patient with a prescribed amount of each fluid solution through the catheter tube.
Abstract (French):
Abstract (German):
Abstract (Original):

A valve is disclosed which includes a hollow cylindrical housing having a plurality of input sites and a rotary core member having an output pasageway. The input sites which are not in communication with the output passageway are sealed. The valve may also include a primary input site connected to a conduit surrounding the rotary core member of the valve. The valve is demountable on a control apparatus for performing a method of administering a plurality of fluids intravenously to a patient. According to the method of the present invention, a neutral solution is provided in between each of the other different fluid solutions being infused into the patient. The control apparatus of the present invention may be programmed to automatically provide the patient with a prescribed amount of each fluid solution through the catheter tube.
Abstract (Spanish):
Claims:

We claim:
1. A valve demountable on a control apparatus for automatically providing selective communication between one of a plurality of available fluid sources and a catheter tube, the valve comprising: *
a hollow cylindrical housing having a plurality of input sites for connection with said fluid sources; *
a core member, rotatably engaged within said housing, having a planar surface on each end and an output passageway extending through said core member from an access hole in a circumference of said core member to an output hole in one of said planar surfaces connected to said catheter tube, said circumference of said core member sealing said input sites such that fluid is prevented from escaping from said input sites except when said access hole is aligned with one of said input sites to provide communication between said input site and said output passageway; *
conduit means for directing fluid from one of said input sites around said remaining input sites so that said fluid from said one of said input sites is in communication with said access hole whenever said access hole is positioned between two adjacent input sites; and *
gear means coupled to said core member for transmitting rotational movement from said control apparatus to said core member.
2. The valve of claim 1 wherein said housing, said gear means and said core member are comprised of a sterilizable plastic material.
3. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites.
4. The valve of claim 3 further comprising a drive member coupled to said core member for transmitting rotational movement to said sealing means.
5. The valve of claim 4 wherein said drive member comprises a gear.
6. The valve of claim 4 wherein said housing, said core member, said drive member and said sealing means are comprised of a sterilizable plastic material.
7. The valve of claim 4 further comprising second sealing means between said housing and said core member for sealing fluids within said conduit means.
8. The valve of claim 3 wherein said secondary input sites comprise hollow cylindrical shafts extending from said housing toward said core member to contact flush against said first sealing means.
9. The valve of claim 4 wherein said conduit means is circumferentially formed around said core member between said sealing means and said housing.
10. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites, each of said secondary input sites having a hollow cylindrical shaft extending into said housing; *
a cylindrical core member rotatable within said housing having flange means extending radially from its circumference and a planar surface on each end, said flange means, said housing and the circumference of said core member forming a conduit in communication with said primary input site, said conduit being wider than the outer diameter of each of said cylindrical shafts and said core member being disposed within said housing such that said cylindrical shafts lie flush against said core member to seal said secondary input sites; *
an output passageway within said core member, accessible through an access hole in the circumference of said core member, said passageway extending through said core member and out through a projection from one of said planar surfaces of said core member; and *
a drive member, for rotating said core member to selectively align the access hole of said output passageway with any of said secondary input sites or with said conduit to communicate fluid from one of said input sites or from said conduit into said output passageway.
11. The valve of claim 10 wherein said drive member comprises a gear.
12. The valve of claim 10 wherein said access hole is wide enough to prevent interruption of fluid flow into said output passageway when said core member is rotating said access hole between said conduit and one of said secondary input sites.
13. A method for administering multiple fluid solutions to a patient, said method comprising: *
providing a sterile valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said multiple fluid solutions to different inputs of said valve; *
connecting a catheter tube between the output of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined time intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said catheter tube.
14. A method for administering a plurality of fluid solutions to a patient, said method comprising; *
providing a sterile valve including a cylindrical housing having a primary input and a plurality of secondary inputs, a core member, disposed within said housing, having an output passageway with an access hole through the circumference of said core member, the circumference sealing closed the secondary input when they are not aligned with the access hole of the output passageway, and a conduit, wherein said conduit directs fluid from said primary input around said secondary inputs so that said fluid from said primary input is in communication with said output passageway whenever said access hole is positioned between two adjacent secondary inputs; *
individually connecting said plurality of fluid solutions to any of said secondary inputs; *
connecting a neutral solution to said primary input; *
connecting a catheter tube between the output passageway of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
rotating said core member to alternately switch the output passageway of said valve into communication with said primary input and with one of said secondary inputs at predetermined time intervals, said neutral solution being provided between each fluid solution to prevent any of said fluid solutions from substantially mixing with another fluid solution in said catheter tube.
15. The method of claim 14 wherein said switching is performed automatically by preprogrammed electronic processor means.
16. The method of claim 14 wherein said pump comprises a peristaltic pump.
17. The method of claim 14 wherein said pump comprises a syringe-type cartridge pump.
18. An apparatus for administering multiple drug infusions comprising: *
(a) a demountable valve including: *
a hollow cylindrical housing having a primary input site and a pluraltiy of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites; and *
a drive member, connected to said core member, for rotating said core member to selectively align said access hole with any of said secondary input sites or with said conduit means to communicate fluid from said input site or from said conduit means into said output passageway; *
(b) motor; *
(c) drive means coupled to said motor engageable with said drive member; and *
(d) microprocessor means for controlling said motor to selectively communicate fluids from said input sites through said output passageway for predetermined time intervals in a predetermined sequence.
19. The apparatus of claim 18 wherein said microprocessor means includes means for controlling said motor to communicate fluids through said output passageway in a sequence alternating between fluid from said conduit means and fluid from any of said secondary input sites.
20. The apparatus of claim 18 further comprising a catheter tube in communication with said output passageway and a pump coupled to said catheter tube for causing fluids to flow from said valve through said catheter tube at a predetermined rate.
21. The apparatus of claim 20 wherein said pump comprises a peristaltic pump.
22. The apparatus of claim 20 wherein said pump comprises a syringe-type cartridge pump.
23. The apparatus of claim 18 wherein said drive member in said valve comprises a gear.
24. The apparatus of claim 18 wherein communication of fluid through said access hole is not interrupted by rotation of said core member.
25. The apparatus of claim 18 further comprising means for causing an alarm prior to exhausting a source of fluid supplying one of said input sites.
Claims Count: 25
Claims (English):

We claim:
1. A valve demountable on a control apparatus for automatically providing selective communication between one of a plurality of available fluid sources and a catheter tube, the valve comprising: *
a hollow cylindrical housing having a plurality of input sites for connection with said fluid sources; *
a core member, rotatably engaged within said housing, having a planar surface on each end and an output passageway extending through said core member from an access hole in a circumference of said core member to an output hole in one of said planar surfaces connected to said catheter tube, said circumference of said core member sealing said input sites such that fluid is prevented from escaping from said input sites except when said access hole is aligned with one of said input sites to provide communication between said input site and said output passageway; *
conduit means for directing fluid from one of said input sites around said remaining input sites so that said fluid from said one of said input sites is in communication with said access hole whenever said access hole is positioned between two adjacent input sites; and *
gear means coupled to said core member for transmitting rotational movement from said control apparatus to said core member.
2. The valve of claim 1 wherein said housing, said gear means and said core member are comprised of a sterilizable plastic material.
3. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites.
4. The valve of claim 3 further comprising a drive member coupled to said core member for transmitting rotational movement to said sealing means.
5. The valve of claim 4 wherein said drive member comprises a gear.
6. The valve of claim 4 wherein said housing, said core member, said drive member and said sealing means are comprised of a sterilizable plastic material.
7. The valve of claim 4 further comprising second sealing means between said housing and said core member for sealing fluids within said conduit means.
8. The valve of claim 3 wherein said secondary input sites comprise hollow cylindrical shafts extending from said housing toward said core member to contact flush against said first sealing means.
9. The valve of claim 4 wherein said conduit means is circumferentially formed around said core member between said sealing means and said housing.
10. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites, each of said secondary input sites having a hollow cylindrical shaft extending into said housing; *
a cylindrical core member rotatable within said housing having flange means extending radially from its circumference and a planar surface on each end, said flange means, said housing and the circumference of said core member forming a conduit in communication with said primary input site, said conduit being wider than the outer diameter of each of said cylindrical shafts and said core member being disposed within said housing such that said cylindrical shafts lie flush against said core member to seal said secondary input sites; *
an output passageway within said core member, accessible through an access hole in the circumference of said core member, said passageway extending through said core member and out through a projection from one of said planar surfaces of said core member; and *
a drive member, for rotating said core member to selectively align the access hole of said output passageway with any of said secondary input sites or with said conduit to communicate fluid from one of said input sites or from said conduit into said output passageway.
11. The valve of claim 10 wherein said drive member comprises a gear.
12. The valve of claim 10 wherein said access hole is wide enough to prevent interruption of fluid flow into said output passageway when said core member is rotating said access hole between said conduit and one of said secondary input sites.
13. A method for administering multiple fluid solutions to a patient, said method comprising: *
providing a sterile valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said multiple fluid solutions to different inputs of said valve; *
connecting a catheter tube between the output of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined time intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said catheter tube.
14. A method for administering a plurality of fluid solutions to a patient, said method comprising; *
providing a sterile valve including a cylindrical housing having a primary input and a plurality of secondary inputs, a core member, disposed within said housing, having an output passageway with an access hole through the circumference of said core member, the circumference sealing closed the secondary input when they are not aligned with the access hole of the output passageway, and a conduit, wherein said conduit directs fluid from said primary input around said secondary inputs so that said fluid from said primary input is in communication with said output passageway whenever said access hole is positioned between two adjacent secondary inputs; *
individually connecting said plurality of fluid solutions to any of said secondary inputs; *
connecting a neutral solution to said primary input; *
connecting a catheter tube between the output passageway of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
rotating said core member to alternately switch the output passageway of said valve into communication with said primary input and with one of said secondary inputs at predetermined time intervals, said neutral solution being provided between each fluid solution to prevent any of said fluid solutions from substantially mixing with another fluid solution in said catheter tube.
15. The method of claim 14 wherein said switching is performed automatically by preprogrammed electronic processor means.
16. The method of claim 14 wherein said pump comprises a peristaltic pump.
17. The method of claim 14 wherein said pump comprises a syringe-type cartridge pump.
18. An apparatus for administering multiple drug infusions comprising: *
(a) a demountable valve including: *
a hollow cylindrical housing having a primary input site and a pluraltiy of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites; and *
a drive member, connected to said core member, for rotating said core member to selectively align said access hole with any of said secondary input sites or with said conduit means to communicate fluid from said input site or from said conduit means into said output passageway; *
(b) motor; *
(c) drive means coupled to said motor engageable with said drive member; and *
(d) microprocessor means for controlling said motor to selectively communicate fluids from said input sites through said output passageway for predetermined time intervals in a predetermined sequence.
19. The apparatus of claim 18 wherein said microprocessor means includes means for controlling said motor to communicate fluids through said output passageway in a sequence alternating between fluid from said conduit means and fluid from any of said secondary input sites.
20. The apparatus of claim 18 further comprising a catheter tube in communication with said output passageway and a pump coupled to said catheter tube for causing fluids to flow from said valve through said catheter tube at a predetermined rate.
21. The apparatus of claim 20 wherein said pump comprises a peristaltic pump.
22. The apparatus of claim 20 wherein said pump comprises a syringe-type cartridge pump.
23. The apparatus of claim 18 wherein said drive member in said valve comprises a gear.
24. The apparatus of claim 18 wherein communication of fluid through said access hole is not interrupted by rotation of said core member.
25. The apparatus of claim 18 further comprising means for causing an alarm prior to exhausting a source of fluid supplying one of said input sites.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A valve demountable on a control apparatus for automatically providing selective communication between one of a plurality of available fluid sources and a catheter tube, the valve comprising: *
a hollow cylindrical housing having a plurality of input sites for connection with said fluid sources; *
a core member, rotatably engaged within said housing, having a planar surface on each end and an output passageway extending through said core member from an access hole in a circumference of said core member to an output hole in one of said planar surfaces connected to said catheter tube, said circumference of said core member sealing said input sites such that fluid is prevented from escaping from said input sites except when said access hole is aligned with one of said input sites to provide communication between said input site and said output passageway; *
conduit means for directing fluid from one of said input sites around said remaining input sites so that said fluid from said one of said input sites is in communication with said access hole whenever said access hole is positioned between two adjacent input sites; and *
gear means coupled to said core member for transmitting rotational movement from said control apparatus to said core member.
Independent Claims:
1. A valve demountable on a control apparatus for automatically providing selective communication between one of a plurality of available fluid sources and a catheter tube, the valve comprising: *
a hollow cylindrical housing having a plurality of input sites for connection with said fluid sources; *
a core member, rotatably engaged within said housing, having a planar surface on each end and an output passageway extending through said core member from an access hole in a circumference of said core member to an output hole in one of said planar surfaces connected to said catheter tube, said circumference of said core member sealing said input sites such that fluid is prevented from escaping from said input sites except when said access hole is aligned with one of said input sites to provide communication between said input site and said output passageway; *
conduit means for directing fluid from one of said input sites around said remaining input sites so that said fluid from said one of said input sites is in communication with said access hole whenever said access hole is positioned between two adjacent input sites; and *
gear means coupled to said core member for transmitting rotational movement from said control apparatus to said core member.
3. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites.
10. A valve for providing selective communication between any one of a plurality of available fluids and an output tube, the valve comprising: *
a hollow cylindrical housing having a primary input site and a plurality of secondary input sites, each of said secondary input sites having a hollow cylindrical shaft extending into said housing; *
a cylindrical core member rotatable within said housing having flange means extending radially from its circumference and a planar surface on each end, said flange means, said housing and the circumference of said core member forming a conduit in communication with said primary input site, said conduit being wider than the outer diameter of each of said cylindrical shafts and said core member being disposed within said housing such that said cylindrical shafts lie flush against said core member to seal said secondary input sites; *
an output passageway within said core member, accessible through an access hole in the circumference of said core member, said passageway extending through said core member and out through a projection from one of said planar surfaces of said core member; and *
a drive member, for rotating said core member to selectively align the access hole of said output passageway with any of said secondary input sites or with said conduit to communicate fluid from one of said input sites or from said conduit into said output passageway.
13. A method for administering multiple fluid solutions to a patient, said method comprising: *
providing a sterile valve that provides continuous communication between an output and at least one of a plurality of inputs; *
connecting a neutral solution to one input of said valve; *
connecting each of said multiple fluid solutions to different inputs of said valve; *
connecting a catheter tube between the output of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
using an electronic processor to alternately switch said valve between the input connected to said neutral solution and one of said other plurality of inputs at predetermined time intervals, said neutral solution being provided between said fluid solutions to prevent said fluid solutions from substantially mixing in said catheter tube.
14. A method for administering a plurality of fluid solutions to a patient, said method comprising; *
providing a sterile valve including a cylindrical housing having a primary input and a plurality of secondary inputs, a core member, disposed within said housing, having an output passageway with an access hole through the circumference of said core member, the circumference sealing closed the secondary input when they are not aligned with the access hole of the output passageway, and a conduit, wherein said conduit directs fluid from said primary input around said secondary inputs so that said fluid from said primary input is in communication with said output passageway whenever said access hole is positioned between two adjacent secondary inputs; *
individually connecting said plurality of fluid solutions to any of said secondary inputs; *
connecting a neutral solution to said primary input; *
connecting a catheter tube between the output passageway of said valve and said patient; *
coupling a pump to said catheter tube; *
operating said pump at a predetermined speed; *
rotating said core member to alternately switch the output passageway of said valve into communication with said primary input and with one of said secondary inputs at predetermined time intervals, said neutral solution being provided between each fluid solution to prevent any of said fluid solutions from substantially mixing with another fluid solution in said catheter tube.
18. An apparatus for administering multiple drug infusions comprising: *
(a) a demountable valve including: *
a hollow cylindrical housing having a primary input site and a pluraltiy of secondary input sites; *
a core member, disposed within said housing, having an output passageway and a first means for sealing; *
said first sealing means having an access hole in communication with said output passageway and being rotatably engaged with said housing to prevent any fluid from escaping from any of said secondary input sites except when said access hole is aligned with one of said secondary input sites to provide communication between said one of said secondary input sites and said output passageway; *
conduit means for directing fluid from said primary input site around said secondary input sites so that said fluid from said primary input site is in communication with said access hole whenever said access hole is positioned between two adjacent secondary input sites; and *
a drive member, connected to said core member, for rotating said core member to selectively align said access hole with any of said secondary input sites or with said conduit means to communicate fluid from said input site or from said conduit means into said output passageway; *
(b) motor; *
(c) drive means coupled to said motor engageable with said drive member; and *
(d) microprocessor means for controlling said motor to selectively communicate fluids from said input sites through said output passageway for predetermined time intervals in a predetermined sequence.
Description:

BACKGROUND OF THE INVENTION

This invention relates to the administration of multiple fluid infusions.

There are many applications for which there is a need for a device which can intravenously administer a plurality of drugs. One such application is the use of chemotherapy to treat diseases such as cancer. Another application is hyperalimentation where several nutritional solutions are intravenously administered to a patient.

Attempts at providing more advanced chemotherapy regimens involving the intravenous administration of a multiplicity of drug solutions are being inhibited by a lack of equipment to simplify such a procedure. Very often if different drug solutions are used, they are administered by using a separate catheter tube for each drug. A separate infusion pump would be used on each individual catheter tube line and the tube would deliver the fluid solution into the patient through its respective intravascular access needle. A patient must pay for each catheter set and must rent a pump for use with each catheter tube. Therefore, it is costly to use multiple catheter tubes and pumps. A further problem would be the discomfort and complications involved in applying and maintaining several vascular access sites in a single patient.

Some physicians administer chemotherapy treatments with a plurality of drug solutions by mixing the solutions together and feeding the mixture into the patient through a single catheter set and pump. If the different drug solutions are compatible, they can be mixed and delivered through a single catheter. Unfortunately, there are only a limited number of drug combinations which can be used in this manner. Many drugs cannot be mixed together prior to infusion. Some drugs react to neutralize one another. Other drugs react to form precipitates which may block the catheter tube or possibly cause an embolism in the patient.

Because of these problems, it is desirable to keep the multiple fluid solutions separated. Attention is directed to the inventors' copending patent application entitled "Method for Sequential Intravenous Infusion of Multiple Fluids", which shares the same filing date and assignee as the present application. The method described in the copending application enables the use of a single catheter tube for multiple drug infusions. In order to deliver a plurality of fluid solutions separately through a single catheter tube, a valve is generally required. The valve must be sterile to perform this application; thus a disposable valve would be preferable. There are some known valves which may be manually adjusted. For example, a rotary mixing valve, invented by Santomieri, is described in U.S. Pat. No. 3, 618,637. However, this valve provides a primary fluid which is commingled with selected secondary fluid solutions and if the valve is rotated to switch between secondary inputs, fluid flow will be interrupted.

SUMMARY OF THE INVENTION

This invention is directed to a method and apparatus for administering multiple fluid infusions. The apparatus includes a valve for selectively communicating any one of a plurality of available fluid solutions with an output tube. The valve includes a hollow cylindrical housing having a primary input site and a plurality of secondary input sites. There is a core member engaged within the hollow cylindrical housing which has an output passageway for coupling the inputs with the output tube. Means are provided around the circumference of the core member for sealing off the input sites which are not in communication with the output passageway through an access hole in the circumference. The primary input site is connected via a conduit with the circumference of the core member so that the fluid provided through the primary input site is in communication with the output passageway whenever the access hole is aligned between two adjacent secondary input sites.

The method of the present invention for administering multiple fluid solutions to a patient begins by providing a sterile valve having a single output and a plurality of inputs. A neutral solution is connected through one input of the valve and the remainder of the inputs are connected to one of several fluid solutions. A catheter tube is connected between the output of the valve and the patient. A pump is coupled to the catheter tube for delivering fluid through the tube at a predetermined speed. The drug regimen is delivered by alternately switching the valve between the input providing the neutral solution and one of the other inputs connected to the drug solutions. The use of this method and valve advantageously avoids a substantial mixing of the drug solutions prior to injection into the patient. Thus, physicians will be given new flexibility in their choice of intravenous drug combinations for use in chemotherapy or other similar treatments.

The apparatus for performing the method of the present invention employs a valve with several input sites and a single output site through an output passageway in a rotary core member. A motor is provided for turning the rotary core member to select the connection between an input and the output passageway. A catheter tube is connected to the valve and a pump is coupled with the catheter tube for delivering fluid through the tube at a predetermined speed. A preprogrammed microprocessor is provided for controlling the motor to provide selected drug solutions to the catheter tube in a predetermined sequence for predetermined time intervals.

It is an object of the present invention to provide a sterile disposable valve for selectively communicating with one of several fluid solutions for input through a catheter tube. It is a further object of the present invention to provide an automatically controlled apparatus for selectively communicating a catheter tube with a selection of fluid solutions. An advantage of the automatic control of the present invention is that it may be programmed to handle any regimen as prescribed.

A still further object of the present invention is to provide a valve having a primary input that is accessible through a conduit between the input sites for the plurality of fluid solutions. This advantageously allows simple implementation of a drug regimen which alternates the provision of a neutral solution with a selected sequence of fluid solutions, since the valve does not need to switch repeatedly its output into alignment with the primary input site. The objective of this neutral solution is to substantially isolate the plurality of fluid solutions that are fed into the catheter tube.

Other objects and advantages of the invention will become apparent during the following description of the presently preferred embodiment of the invention taken in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view of an apparatus of the present invention for administering multiple fluid infusions.

FIG. 2 is a cross-sectional view of a valve of the present invention.

FIG. 3 is a sectional view taken along lines 3--3 of the valve in FIG. 2.

FIG. 4 is another elevational view of the apparatus of FIG. 1.

FIG. 5 is a sectional view of the apparatus of FIG. 4 taken along lines 5--5.

FIG. 6 is a sectional view of the catheter tube shown in FIG. 1 demonstrating the method of the present invention.

FIG. 7 is a cross-sectional view of the catheter tube shown in FIG. 1 after the neutral spacer solution has been pumped through a length of catheter tubing.

FIG. 8 is an elevational view of a peristaltic pump for use in the method and apparatus of the present invention.

FIG. 9 is an elevational view of a syringe-type cartridge pump for use in the method and apparatus of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Turning now to the drawings, FIG. 1 is a simplified elevational view of the apparatus of the present invention. A valve 10 is mounted on control apparatus 20. The valve 10 is shown receiving four inputs from intravenous fluid solution sources. The valve 10 includes rotary core member 12. The rotary core member 12 has an output passageway 14 which is connected to a catheter tube 30 for delivering fluid to a patient. A pump 40 is coupled to the catheter tube for delivering the fluid at a predetermined speed. The pump 40 which is used with the present invention may be any conventional type of infusion pump. The presently preferred embodiment uses a peristaltic pump which is especially well-suited for long duration infusions. The use of a syringe-type cartridge pump is allowable for situations where a higher pressure is required and where larger fluid volumes may be infused into the patient.

Control apparatus 20 has a control panel 22 by which an operator can program the control apparatus 20 to infuse predetermined amounts of each fluid solution into the patient through the catheter tube. An operator would indicate to the apparatus 20 the quantity of each fluid to be pumped per unit time through the catheter tube. The apparatus 20 then computes the required pump speed and displays this information to the operator. The operator sets the pump 40 at this speed. The programmed apparatus automatically switches the valve 10 between fluid solutions to administer the prescribed regimen.

One of the inputs into the valve 10 is a neutral solution which is used as an isolator between drug solutions thereby preventing any substantial premixing of the solutions in the catheter tube 30. The control apparatus 20 will always alternate between the neutral solution and one of the drug solutions. This is the method described in the inventors' copending patent application U.S. Ser. No. 619,846 entitled "Method for Sequential Intravenous Infusion of Multiple Fluids" sharing the same filing date and assignee as the present invention and the disclosure of which is hereby incorporated by reference herein. According to this method, the spacer solution 110 is provided for substantially isolating the different fluid solutions during intravenous administration. FIG. 6 shows a first solution 112 and a second solution 114 separated by the spacer solution 110. The solutions are carried by the catheter tube 30 through a needle and into a patient. Pump 40 keeps the fluids moving through catheter tube 30 at a predetermined rate. The spacer solution 110 must be a solution which is suitable for intravenous infusion into a patient. The spacer 110 must also be neutral with respect to each of the fluid solutions on either side of it. In other words, the spacer solution 110 must not substantially react with either the first fluid solution 112 or the second fluid solution 114 while it is traveling through the catheter tube 30 into the patient. Some solutions may react with one another over a long period of time, however, it is only necessary that there be no adverse reactions prior to the infusion.

There are a number of intravenous solutions which may be selected as the neutral spacer 110, including but not limited to saline solutions, dextrose solutions and intravenous lipid solutions. The appropriate spacer solution 110 should be selected according to a patient's needs. For example, a patient requiring nutritional supplement may receive a high concentration dextrose solution as the spacer, whereas a patient merely requiring liquids may receive a saline solution or a low concentration dextrose solution.

The volume of the spacer solution 110 affects the rate of mixing between the fluid solutions on adjoining sides of the spacer. A spacer with a low volume would have a tendency to allow the adjoining fluids to diffuse more quickly into each other. On the other hand, a spacer with a larger volume would decelerate the rate of diffusion of adjoining drug solutions into each other.

The volume of the spacer solution must be selected so as to avoid substantial mixing between the fluid solutions on either side of the spacer solution 110 in the time that the solutions are in transit within the catheter tube 30. If the diffusion rate between a fluid solution and the spacer solution 110 is rapid, the spacer solution 110 must have a greater volume to avoid mixing of the two isolated fluid solutions. Some insubstantial mixing may be allowed where the first drug solution 112 and the second drug solution 114 are relatively compatible with one another and will not react when in contact to a small extent. For more highly reactive fluid solutions, any amount of mixing would be substantial and must be prevented. Thus, the appropriate volume of spacer 110 depends on a variety of factors.

Because of laminar flow which occurs during the movement of fluids through the catheter tube 30, the type of pump being used will also be determinative of the minimum volume of spacer solution 110 required to separate the first and second fluid solutions. Referring now to FIG. 7, the affects of laminar flow of fluids as they travel through the catheter tube 30 is shown. There is friction between the walls of the catheter tube 30 and the fluids which are flowing through it. This friction slows the outer layers of fluid. Thus, the fastest flowing fluid is found along the center axis of the catheter tube 30. Over a period of travel through the tube the spacer solution 110 develops a convex pointed front side and a concave indented rear side. The volume of spacer solution 110 must be prescribed to be large enough so that the rear edge of the first fluid solution 112 does not substantially overlap the leading front point of fluid solution 114. A cross-section showing such an overlap is illustrated in FIG. 7 at cross-section 116. A peristaltic pump 130, illustrated in FIG. 8, operates by squeezing the catheter tube 30. If there is a cross-section 16 including the first and second fluid solutions as they reach the peristaltic pump 130, upon being squeezed by pump 130 the two solutions would be in direct contact as a result of the pump action. Therefore, it is important that when using a peristaltic pump 130 that there be a cross-section 117 maximally filled with spacer solution 110 as the spacer solution reaches the peristaltic pump 130.

A syringe-type cartridge pump 140, also known as volumetric pump, illustrated in FIG. 9 works in a different manner. The cartridge pump 140 operates by filling and emptying a chamber 42. A valve 44 rotates to switch between a filling and an emptying position. To prevent substantial mixing between fluid solution 112 and second fluid solution 114, it is again necessary to prescribe a sufficient volume of spacer solution 110 to substantially isolate the two fluid solutions. To accomplish this, the spacer solution 110 should encompass a volume which fills a cylindrical cross-section of the tube which is equal to or greater than the volume of the chamber 42. Thus, the pump chamber 42 will be prevented from substantially filling with more than one of the fluid solutions separated by the spacer 110.

It is highly important that the infused fluid solutions are not contaminated. Therefore, it is important that the valve 10 be sterile. The presently preferred embodiment employs a disposable plastic valve 10 which can withstand a conventional sterilization process.

The apparatus of the present invention individually connects a fluid solution through an input site 18 in the valve 10 with an output passageway 14 through the rotary core member 12 of the valve 10. The output passageway 14 is directly connected with the catheter tube 30. During the time interval in which the rotary core member 12 is turned to switch the connection from one solution to another, there is an instant in which both the input site 18 and the conduit 50 are exposed to the output passageway 14. Then there is an interval in which solely the neutral solution is pumped from conduit 50 through the catheter tube 30. Thus, the flow of fluid into the catheter tube 30 is continuous and is never interrupted. As the rotary core member 12 is turned to switch from conduit 50 to an input site 18, the flow of fluid into the catheter tube 30 is similarly continuous and never interrupted.

Referring now to FIGS. 2 and 3, the valve of the present invention may be described in greater detail. The valve 10 is supported in a hollow cylindrical housing 16. The housing 16 is mountable on the apparatus 20 by its mounting holes 15 and a lip 24. At the top of the valve 10, lip 24 extends outward so as to fit under ridge 25 which extends from control apparatus 20. Pins 23 projecting out of the control apparatus 20 snap into the mounting holes 15. Any conventional mounting means may be substituted for the mounting holes 15 and lip 24 as long as the valve 10 can be securely held in place and may be easily dismounted for replacement with a new sterile valve 10.

The housing 16 includes a plurality of input sites. In the preferred embodiment, there is one primary site 17 and a plurality of secondary sites 18. Each input site is a hole through the circumference of the hollow housing 16. The input site accommodates a hollow cylindrical shaft. In the case of the secondary input sites, the hollow cylindrical shafts 19 extend through the hollow housing 16 and into contact with sealing means surrounding the rotary core member 12. In the preferred embodiment, it is the circumference 13 of the rotary core member 12 which contacts and seals the cylindrical shafts 19. The ends of the shafts 19 are ground with a curve matching that of the circumference 13 of the rotary core member 12 so that the shafts lie flush against the circumference 13 to effectuate a seal. It would be possible however to provide a washer type device about the rotary core member to function as the sealing means.

The output passageway 14 extends through rotary core member 12 from an access hole 11 in the circumference 13. When the access hole 11 is not aligned with a secondary input site 18, that input site 18 will be sealed closed by the circumference 13. The primary input site 17 has a shaft 21 which does not extend to the sealing means on the rotary core member 12. Thus, access is always maintained between the primary input site 17 and a conduit 50 which surrounds the rotary core member 12. In the presently preferred embodiment, the conduit 50 is formed by the rotary core member 12 itself. The rotary core member 12 is spool-shaped to form the channel-like conduit 50 about its circumference. The conduit 50 is formed with circumference 13 as the floor and sidewalls extending from the planar surface ends of the core member 12. The conduit 50 is wider than the outer diameter of the hollow cylindrical shafts 19. Thus, as shown in FIG. 3, the conduit 50 extends around each of the secondary input sites. This enables the neutral solution which is fed through the primary input site 17 to fill the conduit 50 all the way around the rotary core member 12.

The conduit 50 simplifies the sequential switching operation of valve 10. Since treatments involve a plurality of drugs, it is desirable to avoid substantial mixing of the drugs in the catheter tube 30. To accomplish this, the neutral solution is accessed after each use of a drug solution. The conduit 50 provides access to the neutral solution between adjacent secondary input sites 18. Thus, the core member 12 can rotate directly from one solution to another and still access neutral solution in between. This construction also promotes protection against air bubbles in the line. The access hole 11 is made wider than the walls of the hollow shafts 19 so that fluid can be continuously pulled through the catheter tube 30. As the access hole 11 is moved out of direct alignment with a secondary input site 18, it will be instantaneously exposed to solution from the input site 18 and from the conduit 50. Then it will allow passage solely of the neutral solution from the conduit 50. Thus, there will be a continuous flow of fluid which will prevent air bubbles from ever forming within the system.

At the external end of each hollow cylindrical shaft 19, there is a male luer connector for mating with a female luer connector on the polymer catheter tube bringing fluid from the intravenous fluid solution source. Any conventional connecting means may be substituted for the present male-female luer connection.

The conduit 50 carrying the neutral solution must be sealed to prevent leakage. In the presently preferred embodiment, a double seal is provided by the rotary core member 12 against the hollow cylindrical housing 16. The outer planar surfaces of the rotary core member 12 frictionally engage an inner wall of a channel 26 within the inner circumference of the hollow cylindrical housing 16. The outermost circumference of the sidewalls of the rotary core member 12 frictionally engages the floor of the channel 26 in the hollow housing 16. The snug fit of the rotary core member within the hollow housing thus functions to seal the conduit 50.

The output passageway 14 is shown in FIGS. 2 and 3. It extends from the access hole 11 in the circumference 13 of the rotary core member 12 to an output site projecting from one of the planar surfaces of the core. A catheter tube 30 makes connection with the outer projection from the core 12 to provide a path for the fluid to follow. Automatic mechanical rotation of the valve 10 is made possible by the connection of a gear 60 to the rotary core member 12. The teeth of the gear 60 mesh with the teeth of a gear 80 within the control apparatus 20 so that a motor 70 within the control apparatus may control the operation of the valve 10. The engagement of the two gears further contributes to holding the valve 10 in its mounted position on the control apparatus 20.

Referring now to FIGS. 4 and 5, the mechanics of the control apparatus 20 may be explained. A stepping motor 70 rotates a pulley 72. The pulley 72 is connected by a belt 74 to a pulley 76 on a speed reducer 78. The belt 74 thus drives the speed reducer 78. The speed reducer 78 transmits torque from the motor 70 to a gear 80 which is enmeshed with the gear 60 on the valve 10. In the presently preferred embodiment, the speed reducer uses a ratio of 48 to 1. In reducing the speed, the speed reducer 78 effectively increases the torque which is applied to the gear 60 on the valve 10. The increased torque enables the rotary core member 12 to turn against the friction from the hollow housing. Any conventional means of speed reduction may be substituted for the present drive train.

The stepping motor 70 is controlled by a microprocessor located on a circuit board 90 at the rear of the control apparatus 20. Power for the microprocessor circuitry and the motor 70 is provided from a line cord 92 which is connected through a power supply 94. It is preferable to include a backup battery supply which would be automatically switched on should the power supplied over the line cord 92 be disrupted. The microprocessor circuitry also receives inputs from the control panel 22. The control panel 22 is used to program the microprocessor so that one control apparatus 20 may be used to operate the valve 10 for administering an unlimited variety of prescribed regimens.

The present invention makes possible the administration of advanced treatments using a plurality of drug solutions. The use of a greater variety of drug solutions is possible since the apparatus allows the use of a neutral solution as a spacer to prevent substantial mixing of the drug solutions in the catheter tube 30. The operation of the apparatus begins with mounting the valve 10 on the control apparatus 20. The fluid solutions are connected to the input sites 18 of the valve 10. A pump 40 is coupled to the catheter tube 30. The pump 40 is turned on and the catheter set is purged of air. The operator causes the valve 10 to turn through each input site position by pressing an appropriate button on the control panel 22. The controls and microprocessor means for implementing the controls may be provided by one skilled in the art. The operator leaves the valve 10 in each input site position until all air bubbles have been removed. The pump is then turned off.

The apparatus may now be initialized. The microprocessor memory is cleared. The volume of the neutral solution source is entered. The volume of the spacer size which is prescribed for use between the fluid solutions is entered. Then the volume of the other fluid solution sources and their prescribed rates of infusion are entered. The pumping rate or speed of pump 40 and the total volume of fluid to be infused per unit time are computed automatically and displayed to the operator on a display 26. The operator then instructs pump 40 to infuse at this speed and for this total volume. After the information has been fed into the microprocessor, thereby programming the apparatus to administer the prescribed regimen, the intravascular access needle on the catheter tube 30 is inserted into the patient and the pump 40 and control apparatus 20 are started.

The infusion process then proceeds automatically. The control apparatus 20 may be provided with an alarm that would sound after a calculated time period elapses which indicates that a solution is in need of refilling. A nurse would stop the pump and press a pause button on the control panel 22. The fluid source would be replaced or refilled. The line is purged if necessary. The new volume of fluid is entered into the control panel 22. Any necessary changes may be made to other variables entered into the apparatus. Then the pump 40 and control apparatus 20 may be restarted.

The present invention only requires a single pump and catheter tube to deliver all of the fluid solutions to the patient. The control panel can be programmed to set the amounts of fluid solutions to be provided to the patient, thereby satisfying a physician's particularly prescribed regimen. The valve of the invention is designed to effectively seal each of the drug solutions from one another so that no undesirable precipitates or reactions occur prior to the infusion. This invention thereby advantageously expands the number of drug solutions available to physicians for use in multiple drug infusion treatments. The neutral solution may be easily accessed between the input sites of the other fluid solutions to provide a spacer between the solutions in the catheter tube 30.

The valve assembly is made of a plastic that may be sterilized by a conventional method. It may be easily mounted and dismounted from the control apparatus so that it may be replaced by a new, sterile valve as needed. The disposability of the valve enhances the integrity of the sterility of the infusion system. The apparatus of the present invention has thus made possible a new and simplified method for administering a number of drug solutions to a patient through a single catheter tube attached to a single pump, without substantially mixing the drugs in the catheter tube.

Of course, it should be understood that various changes and modifications to the preferred embodiment described above will be apparent to those skilled in the art. The valve of the present invention may be of use in a variety of applications. For example, the inputs may be attached to liquor bottles and the valve may be used to mix preprogrammed drinks, or the inputs may be attached to various chemical solutions to facilitate processing within a manufacturing environment. Furthermore, the number and position of the input sites in the hollow housing may be altered to simplify the molding process for producing the valve. These and other changes can be made without departing from the spirit and the scope of the invention and without diminishing its attendant advantages. It is therefore intended that such changes and modifications be covered by the following claims.
Assignee/Applicant: I Flow Corporation,Redondo Beach,CA,US
Assignee/Applicant First: I Flow Corporation,Redondo Beach,CA,US
Assignee - Standardized: I FLOW CORP
Assignee - Original: I Flow Corporation
Assignee - Original w/address: I Flow Corporation,Redondo Beach,CA,US
Assignee Count: 1
Inventor: Brown, Eric W. | Tai, Henry T.
Inventor First: Brown, Eric W.
Inventor - Original: Brown, Eric W. | Tai, Henry T.
Inventor - w/address: Brown Eric W.,Redondo Beach,CA,US | Tai Henry T.,Pacific Palisades,CA,US
Inventor Count: 2
Attorney/Agent: Asher, Robert M.
Attorney/Agent - w/Address: Asher Robert M.
Correspondent:
Correspondent - w/Address:
Examiner: Rosenbaum, C. Fred / Lester, Michelle N.
Publication Country Code: US
Publication Kind Code: A
Publication Date: 1986-08-05
Publication Month: 08
Publication Year: 1986
Application Number: US1984619847A
Application Country: US
Application Date: 1984-06-12
Application Month: 06
Application Year: 1984
Application with US Provisional: US1984619847A | 1984-06-12
Priority Number: US1984619847A
Priority Country: US
Priority Date: 1984-06-12
Priority Date - Earliest: 1984-06-12
Priority Month: 06
Priority Year(s): 1984
Earliest Priority Year: 1984
Related Application Table:
PCT App Number:
PCT App Date:
PCT Pub Number:
PCT Pub Date:
IPC - Current: A61M0005168
IPC Class Table:
IPCSectionClassSubclassClass GroupSubgroup
A61M0005168
A
A61
A61M
A61M0005
A61M0005168
Any CPC Table:
TypeInventionAdditionalVersionOffice
Current

A61M 5/16827

-

20130101

EP

Current

-

Y10T 137/86501

20150401

EP

Current Combination Codes CPC Table:
Any Combination Codes CPC Table:
US Class: 604248, 13762511, 604081
US Class (divided): 604/248, 137/62511, 604/081
US Class - Main: 604248
US Class - Original: 604248 | 13762511 | 604081
ECLA: A61M0005168A11
Locarno Class:
JP F Terms:
JP FI Codes:
Cited Refs - Non-patent: Ivent Corp., ad from Medical Electronics and Equipment News, Aug. 1984, vol. 24, No. 4. | Hutchinson, Administration of Fat Emulsions, American Journal of Nursing, Feb., 1982.
Count of Cited Refs - Non-patent: 2
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Turney Stephen Z.
TURNEY S
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1965-05-25
ANDREW HARAUTUNEIAN
PHARMASEAL LAB
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WILLIAM BIERMAN
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BAXTER TRAVENOL LAB
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INSTRUMENTATION LABOR INC
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BAXTER TRAVENOL LAB
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1981-05-05
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1980-08-26
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ABBOTT LAB
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Title: Equipment sets for the sequential administration of medical liquids at dual flow rates having parallel secondary liquid flowpaths wherein one said path is controlled by a liquid sequencing valve
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MEDEX INC
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0 (Examiner)
Title: STOP COCK
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1971-11-09
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DESERET PHARMA
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0 (Examiner)
Title: ROTARY MIXING VALVE
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1963-12-31
ROBERTS SYLVIA V
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0 (Examiner)
Title: Water temperature selector valve
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1978-09-05
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1978-06-13
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BURRON MEDICAL PROD INC
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0 (Examiner)
Title: Electronic control means for a plurality of intravenous infusion sets
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1917-06-05
MUELLER AUGUST E
THOMAS J HRUBY
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Title: VALVE
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1981-03-24
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Title: Multi-channel venipuncture infusion set
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1962-10-09
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1961-12-12
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1980-08-26
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1980-04-08
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AGFA GEVAERT AG
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1978-10-24
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1976-05-18
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ARBROOK INC
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1973-11-27
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1982-04-13
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ABBOTT LAB
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1981-04-14
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BAXTER TRAVENOL LAB
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Title: Method and apparatus for controlling the dispensing of fluid
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1980-06-17
Jenkins Jon A.
IMED CORP
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0 (Examiner)
Title: System for controlling the flow of intravenous fluids to a patient
Count of Cited Refs - Patent: 45
Citing Patents Table:
Publication NumberPublication DateAssignee/Applicant
AU198826302A
1989-06-08
FISHER SCIENTIFIC CO
AU2008266024B2
2014-02-06
SPANDORFER MICHAEL
AU603751B2
1990-11-22
IMED CORP
AU603751B
1990-11-22
Imed Corporation
CN101583335B
2014-07-02
NESTLE HEALTHCARE NUTRITION
DE29715833U1
1998-02-05
FILTERTEK BV
DE4004134A1
1991-08-29
WEX ROLAND
DE4004134C2
1992-01-16
WEX ROLAND 3508 MELSUNGEN DE
EP345396A1
1989-12-13
FISHER SCIENTIFIC CO
EP442135A2
1991-08-21
WEX ROLAND
EP442135B1
1994-11-23
WEX ROLAND
EP660727B1
1997-12-17
HAINDL HANS
US20080308101A1
2008-12-18
-
US20110264070A1
2011-10-27
-
US4705506A
1987-11-10
MINNESOTA MINING &amp; MFG
US4723946A
1988-02-09
KAY DENNIS M
US4758235A
1988-07-19
TU HO C
US4850980A
1989-07-25
FISHER SCIENTIFIC CO
US4925444A
1990-05-15
BAXTER TRAVENOL LAB
US5104387A
1992-04-14
ST JUDE MEDICAL
US5190524A
1993-03-02
WEX ROLAND
US5207643A
1993-05-04
BALLARD MED PROD
US5272992A
1993-12-28
GREENTRAC LTD
US5288290A
1994-02-22
ALCON SURGICAL INC
US5403290A
1995-04-04
NOBLE; LISA W
US5443453A
1995-08-22
SHERWOOD MEDICAL CO
US5454792A
1995-10-03
HYPROTECK INC
US5584671A
1996-12-17
SHERWOOD MEDICAL CO
US5613511A
1997-03-25
VERNTOFTA AB
US5649810A
1997-07-22
SHERWOOD MEDICAL CO
US5658248A
1997-08-19
LOCALMED INC
US5695478A
1997-12-09
HAINDL; HANS
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1998-12-15
LIVERNASH; ROBERT A
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1999-09-28
HYDRO SYSTEMS CO
US6135153A
2000-10-24
CLELAND SR JOHN
US6423050B1
2002-07-23
TWARDOWSKI ZBYLUT J
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2005-07-19
SCIMED LIFE SYSTEMS INC
US6932112B2
2005-08-23
BRADFORD III LAWRENCE J
US7172572B2
2007-02-06
BOSTON SCIENT SCIMED INC
US7462170B2
2008-12-09
COVIDIEN AG
US7608059B2
2009-10-27
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2009-12-15
MEDIMOP MEDICAL PROJECTS LTD
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2010-07-13
COVIDIEN AG
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2010-07-13
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2011-01-04
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2011-02-01
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2011-02-15
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2011-06-14
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2011-08-16
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2011-10-11
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2011-12-06
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2012-11-27
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US8435210B2
2013-05-07
ZINGER FREDDY
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2013-07-09
SIMON MICHAEL G
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2013-10-15
SIMON MICHAEL G
US8608723B2
2013-12-17
LEV NIMROD
US8684994B2
2014-04-01
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US8752598B2
2014-06-17
DENENBURG IGOR
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2014-06-17
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US8852145B2
2014-10-07
DENENBURG IGOR
US8857429B2
2014-10-14
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SPANDORFER MICHAEL
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1987-12-08
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1997-05-27
Sherwood Medical Company
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MEDIMOP MEDICAL PROJECTS LTD
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1994-03-31
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WO1994012225A1
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LANG VOLKER
WO2008064046A2
2008-05-29
NOVARTIS AG
WO2008081424A2
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PLASTMED LTD
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WO2013055278A1
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TOERNBLOM MICAEL
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HYCLONE LAB INC
Count of Citing Patents: 88
INPADOC Legal Status Table:
Gazette DateCodeINPADOC Legal Status Impact
2009-12-11
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0133 2009-11-25
2009-12-03
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE BY SECURED PARTY; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023639/0135 2009-11-25
2009-11-30
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, CALIFORNIA RELEASE; ASSIGNOR:SILICON VALLEY BANK; REEL/FRAME:023627/0962 2009-11-25
1997-10-06
FPAY
+
Description: FEE PAYMENT
1996-10-08
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:008059/0527 1996-07-18
1995-11-13
AS
-
Description: ASSIGNMENT SILICON VALLEY BANK, CALIFORNIA SECURITY INTEREST; ASSIGNOR:I-FLOW CORPORATION; REEL/FRAME:007737/0015 1995-08-11
1994-02-07
FPAY
+
Description: FEE PAYMENT
1989-08-31
FPAY
+
Description: FEE PAYMENT
1987-03-24
CC
-
Description: CERTIFICATE OF CORRECTION
1985-10-10
AS
-
Description: ASSIGNMENT TAI, HENRY T. ASSIGNS A FIFTY-ONE PERCENT INTEREST (51%).; ASSIGNOR:I-FLOW BIOMEDICAL COMPANY, A CALIFORNIA PARTNERSHIP; REEL/FRAME:004476/0670 1985-08-05
1985-10-10
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, A CORP OF CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNOR:BROWN, ERIC W.; REEL/FRAME:004476/0668 1985-08-05
1985-10-10
AS
-
Description: ASSIGNMENT BROWN, ERIC W. ASSIGNS A FORTY-NINE PERCENT INTEREST (49%).; ASSIGNOR:I-FLOW BIOMEDICAL COMPANY, A CALIFORNIA PARTNERSHIP; REEL/FRAME:004476/0666 1985-08-05
1985-10-10
AS
-
Description: ASSIGNMENT I-FLOW CORPORATION, A CORP OF CALIFORNIA ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNOR:TAI, HENRY T.; REEL/FRAME:004476/0664 1985-08-05
1984-06-12
AS
-
Description: ASSIGNMENT I-FLOW BIOMEDICAL P.O. BOX 335, PACIFIC PALISADES, ASSIGNMENT OF ASSIGNORS INTEREST.; ASSIGNORS:TAI, HENRY T.; BROWN, ERIC W.; REEL/FRAME:004272/0961 1984-06-07
Post-Issuance (US): CORR-CERT Certificate of Correction 1987-03-24 1987
Maintenance Status (US): CC
Reassignment (US) Table:
AssigneeAssignorDate SignedReel/FrameDate
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Conveyance: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0133
2009-12-11
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023627/0962
2009-11-30
Conveyance: RELEASE
Corresponent: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1996-07-18
008059/0527
1996-10-08
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: LEVY, SMALL & LALLAS WALTER S. MITCHELL, ESQ. 815 MORAGA DRIVE LOS ANGELES, CA 90049
SILICON VALLEY BANK,SANTA CLARA,CA,US
I-FLOW CORPORATION
1995-08-11
007737/0015
1995-11-13
Conveyance: SECURITY INTEREST (SEE DOCUMENT FOR DETAILS).
Corresponent: FLORENCE G. KNISLEY SILICON VALLEY BANK ATTN: LOAN DOCUMENTATION GROUP 3003 TASMAN DRIVE SANTA CLARA, CA 95054
TAI HENRY T.,MA,US
I-FLOW BIOMEDICAL COMPANY, A CALIFORNIA PARTNERSHIP
1985-08-05
004476/0670
1985-10-10
Conveyance: ASSIGNS A FIFTY-ONE PERCENT INTEREST (51%).
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
I-FLOW CORPORATION A CORP OF,CA,US
BROWN, ERIC W.
1985-08-05
004476/0668
1985-10-10
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
BROWN ERIC W.,MA,US
I-FLOW BIOMEDICAL COMPANY, A CALIFORNIA PARTNERSHIP
1985-08-05
004476/0666
1985-10-10
Conveyance: ASSIGNS A FORTY-NINE PERCENT INTEREST (49%).
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
I-FLOW CORPORATION A CORP OF,CA,US
TAI, HENRY T.
1985-08-05
004476/0664
1985-10-10
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
I-FLOW BIOMEDICAL P.O. BOX 335 PACIFIC PALISADES CA 90272 A PARTNERSHIP OF,CA,US
TAI, HENRY T.
1984-06-07
004272/0961
1984-06-12
BROWN, ERIC W.
1984-06-07
Conveyance: ASSIGNMENT OF ASSIGNORS INTEREST.
Corresponent: ROBERT M. ASHER DIKE, BRONSTEIN, ROBERTS, CUSHMAN & PFUND 130 WATER ST. BOSTON, MA 02109
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I-FLOW CORPORATION,LAKE FOREST,CA,US
SILICON VALLEY BANK
2009-11-25
023639/0135
2009-12-03
Reassignment (US) - Conveyance - Latest: RELEASE BY SECURED PARTY (SEE DOCUMENT FOR DETAILS).
Reassignment (US) - Corresponent - Latest: UCC DIRECT SERVICES ATTN: 14080632 187 WOLF ROAD, SUITE 101 ALBANY, NY 12205
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US4604093A
19860805
Brown Eric W.
I FLOW CORP
Title: APPARATUS AND METHOD FOR ADMINISTERING MULTIPLE FLUID INFUSIONS
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EP1034734A1Method for improving patient compliance with a medical program | Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten | Procédé servant à améliorer la conformité d'un patient à un programme médical
Publication Number: EP1034734A1  
Title: Method for improving patient compliance with a medical program | Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten | Procédé servant à améliorer la conformité d'un patient à un programme médical
Title (Original): Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten | Method for improving patient compliance with a medical program | Procédé servant à améliorer la conformité d'un patient à un programme médical | Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten
Title (English): Method for improving patient compliance with a medical program
Title (French): Procédé servant à améliorer la conformité d'un patient à un programme médical
Title (German): Verfahren zur Verbesserung der Befolgung eines medizinisches Programmes durch einen Patienten
Title (Spanish):
Title - DWPI: Remote patient monitor has detectors on medication containers causing transmission of use signals and tracking by remote location
Abstract:


A medical system method comprises steps in using portable medication dispensing and data taking devices for use by an out-patient, and which communicate with a base station, typically within the patients' home. The base station communicates periodically with a remote control station which downloads a medical schedule to the base station and thereby to the portable devices, and also receives usage and medical state information from the patient through the portable devices and the base station. A transmission repetition protocol is used which provides a high degree of confidence that patient information will be received by the remote station. The remote station monitors patient activities and status and provides reports as well as refill requests when supplies are low. Presentations to the patient are provided by Internet or other simplified technique including showing history graphics while describing important features and recommending purchases of supplies and medications.

A medical system method comprises steps in using portable medication dispensing and data taking devices for use by an out-patient, and which communicate with a base station, typically within the patients' home. The base station communicates periodically with a remote control station which downloads a medical schedule to the base station and thereby to the portable devices, and also receives usage and medical state information from the patient through the portable devices and the base station. A transmission repetition protocol is used which provides a high degree of confidence that patient information will be received by the remote station. The remote station monitors patient activities and status and provides reports as well as refill requests when supplies are low. Presentations to the patient are provided by Internet or other simplified technique including showing history graphics while describing important features and recommending purchases of supplies and medications. <IMAGE>
Abstract (English):

A medical system method comprises steps in using portable medication dispensing and data taking devices for use by an out-patient, and which communicate with a base station, typically within the patients' home. The base station communicates periodically with a remote control station which downloads a medical schedule to the base station and thereby to the portable devices, and also receives usage and medical state information from the patient through the portable devices and the base station. A transmission repetition protocol is used which provides a high degree of confidence that patient information will be received by the remote station. The remote station monitors patient activities and status and provides reports as well as refill requests when supplies are low. Presentations to the patient are provided by Internet or other simplified technique including showing history graphics while describing important features and recommending purchases of supplies and medications.
Abstract (French):
Abstract (German):
Abstract (Original):

A medical system method comprises steps in using portable medication dispensing and data taking devices for use by an out-patient, and which communicate with a base station, typically within the patients' home. The base station communicates periodically with a remote control station which downloads a medical schedule to the base station and thereby to the portable devices, and also receives usage and medical state information from the patient through the portable devices and the base station. A transmission repetition protocol is used which provides a high degree of confidence that patient information will be received by the remote station. The remote station monitors patient activities and status and provides reports as well as refill requests when supplies are low. Presentations to the patient are provided by Internet or other simplified technique including showing history graphics while describing important features and recommending purchases of supplies and medications.
Abstract (Spanish):
Claims:
1. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medication storing means, a medication accessing means, a dispensed medication counting means, and a medical device wave energy communicating means; *
b) sequencing a counter of the dispensed medication counting means each time the medication accessing means is manipulated for access to the medication storing means; *
c) establishing a data set comprising each new numerical value of the counter and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
2. The method of claim 1 further comprising the step of activating a human responsive signaling means in accordance with a medical schedule so as to provoke the scheduled and timely use of the portable medical device means.
3. The method of claim 1 further comprising the step of transmitting the medication schedule from the base station to the medical device means.
4. The method of claim 3 further comprising the step of transmitting the data set values of the medical device means to the base station.
5. The method of claim 4 further comprising the steps of providing a remote monitoring station; receiving the data set values from the base station at the remote monitoring station; computing a graphical correlation between the received data set values and a selected medical schedule, and transmitting the graphical correlation to the patient.
6. The method of claim 5 further comprising the step of composing a refill request message and of transmitting the refill request message to the patient.
7. The method of claim 5 further comprising the step of composing a graphical summary report showing a time sequence of medication dispensing over a selected time duration, and correlated thereto a time sequence of a corresponding medical data measurement over the selected time duration.
8. The method of claim 1 further comprising the steps of storing a list of all said data sets established over the selected period of transmission time; transmitting the list repetitively at a selected frequency of transmission.
9. The method of claim 1 further comprising the steps of pairing each of the data sets with a digital data integrity checking code and further providing an error-reducing protocol operating on the data sets as received for providing error reduction.
10. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medical state sensing means, a medical state value recording means, and a medical device wave energy communicating means; *
b) recording the medical state each time the medical state sensing means is manipulated for sensing the medical state; *
c) establishing a data set comprising each new value of the medical state and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
11. The method of claim 10 further comprising the step of activating a human responsive signaling means in accordance with a medical schedule so as to provoke the scheduled and timely use of the portable medical device means.
12. The method of claim 10 further comprising the step of transmitting the medical state sensing schedule from the base station to the medical device means.
13. The method of claim 12 further comprising the step of transmitting the data set values of the medical device means to the base station.
14. The method of claim 13 further comprising the steps of providing a remote monitoring station; receiving the data set values from the base station at the remote monitoring station; computing a graphical correlation between the received data set values and a selected medical schedule, and transmitting the graphical correlation to the patient.
15. The method of claim 10 further comprising the steps of storing a list of all said data sets established over the selected period of transmission time and then transmitting the list repetitively at a selected frequency of transmission.
16. The method of claim 10 further comprising the steps of pairing each of the data sets with a digital data integrity checking code and further providing an error-reducing protocol operating on the data sets as received for providing error reduction.
17. A method for creating video screens in a medical monitoring and control system comprising the sequenced steps: *
a) logging a sequence of health event data into a data storage means at each of a plurality of time dependent data logging events; *
b) transmitting each of a plurality of the sequence of health event data to a remote monitoring center in accordance with a preferred transmission schedule; *
c) merging the health event data of the several sequences of health event data as a non-redundant set of such health event data; *
d) producing a health status report in accordance with the non-redundant set of heath event data; *
e) evaluating the health status report; *
f) recording professional comments concerning the health status report as a video and audio presentation; and *
g) adapting the recording and the health status report for electronic transmission on demand.
18. The method of claim 17 wherein the recorded comments comprise subject matter of at least one of: a familiarity commentary, a clinical review of graphical records, a health parameter trend information, a behavioral parameter trend information, and a needed products available for purchase information.
19. The method of claim 17 wherein the recorded comments comprise subject matter of at least one of: a positive behavioral reinforcement, an educational information, a purchasing information, at least one suggestion for improved patient behavior, and at least one of: clues, recommendations, acknowledgements and replies.
20. The method of claim 17 further comprising the step of producing a video screen comprising a first portion of the video screen depicting the health status report and a second portion of the video screen, adjacent to the first portion, depicting the professional comments recording.
21. The method of claim 17 wherein the comments recording comprises at least one of: behavior reinforcing comments, educational comments, and reassurance comments wherein the comments recording is directed for improving patient behavior.
22. The method of claim 17 wherein the comments recording comprises a summary of the health status report including medical significance and recommended changes in patient behavior and medications.
23. The method of claim 17 wherein the comments recording comprises at least one of: recommendations, suggestions, encouragements, demands, and clues for patient purchases.
24. The method of claim 17 further comprising the step of incorporating into the video screen, a plurality of action initiating button icons, and the further step of integrating the button icons with actions related to choices presented in the professional comments recording.
25. The method of claim 24 wherein at least one of the action initiating button icons is enabled for at least one of: a video presentation of medical products and supplies recommended for purchase and an initiating video screen for the purchase of the medical products and supplies recommended in the professional comments recording.
26. The method of claim 24 wherein at least one of the action initiating button icons is enabled for restarting the professional comments recording.
27. The method of claim 24 wherein at least one of the action initiating button icons is enabled for transmitting a message to a medical professional.
28. The method of claim 17 further comprising the step of incorporating into the video screen, a graphical representation of a medical device, and the further step of integrating the button icons with actions related to operation of the medical device.
29. The method of claim 17 further comprising the step of producing a video screen comprising a graphical listing of a plurality of commercial medical products related to the health status report and the professional comments and a graphical means for selecting any of said products on the screen.
30. The method of claim 29 wherein the video screen producing step further produces a graphical selection means for selecting a method of billing.
31. The method of claim 17 further comprising the additional step of notifying the patient that a video report is available for viewing.
Claims Count: 31
Claims (English):
1. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medication storing means, a medication accessing means, a dispensed medication counting means, and a medical device wave energy communicating means; *
b) sequencing a counter of the dispensed medication counting means each time the medication accessing means is manipulated for access to the medication storing means; *
c) establishing a data set comprising each new numerical value of the counter and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
2. The method of claim 1 further comprising the step of activating a human responsive signaling means in accordance with a medical schedule so as to provoke the scheduled and timely use of the portable medical device means.
3. The method of claim 1 further comprising the step of transmitting the medication schedule from the base station to the medical device means.
4. The method of claim 3 further comprising the step of transmitting the data set values of the medical device means to the base station.
5. The method of claim 4 further comprising the steps of providing a remote monitoring station; receiving the data set values from the base station at the remote monitoring station; computing a graphical correlation between the received data set values and a selected medical schedule, and transmitting the graphical correlation to the patient.
6. The method of claim 5 further comprising the step of composing a refill request message and of transmitting the refill request message to the patient.
7. The method of claim 5 further comprising the step of composing a graphical summary report showing a time sequence of medication dispensing over a selected time duration, and correlated thereto a time sequence of a corresponding medical data measurement over the selected time duration.
8. The method of claim 1 further comprising the steps of storing a list of all said data sets established over the selected period of transmission time; transmitting the list repetitively at a selected frequency of transmission.
9. The method of claim 1 further comprising the steps of pairing each of the data sets with a digital data integrity checking code and further providing an error-reducing protocol operating on the data sets as received for providing error reduction.
10. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medical state sensing means, a medical state value recording means, and a medical device wave energy communicating means; *
b) recording the medical state each time the medical state sensing means is manipulated for sensing the medical state; *
c) establishing a data set comprising each new value of the medical state and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
11. The method of claim 10 further comprising the step of activating a human responsive signaling means in accordance with a medical schedule so as to provoke the scheduled and timely use of the portable medical device means.
12. The method of claim 10 further comprising the step of transmitting the medical state sensing schedule from the base station to the medical device means.
13. The method of claim 12 further comprising the step of transmitting the data set values of the medical device means to the base station.
14. The method of claim 13 further comprising the steps of providing a remote monitoring station; receiving the data set values from the base station at the remote monitoring station; computing a graphical correlation between the received data set values and a selected medical schedule, and transmitting the graphical correlation to the patient.
15. The method of claim 10 further comprising the steps of storing a list of all said data sets established over the selected period of transmission time and then transmitting the list repetitively at a selected frequency of transmission.
16. The method of claim 10 further comprising the steps of pairing each of the data sets with a digital data integrity checking code and further providing an error-reducing protocol operating on the data sets as received for providing error reduction.
17. A method for creating video screens in a medical monitoring and control system comprising the sequenced steps: *
a) logging a sequence of health event data into a data storage means at each of a plurality of time dependent data logging events; *
b) transmitting each of a plurality of the sequence of health event data to a remote monitoring center in accordance with a preferred transmission schedule; *
c) merging the health event data of the several sequences of health event data as a non-redundant set of such health event data; *
d) producing a health status report in accordance with the non-redundant set of heath event data; *
e) evaluating the health status report; *
f) recording professional comments concerning the health status report as a video and audio presentation; and *
g) adapting the recording and the health status report for electronic transmission on demand.
18. The method of claim 17 wherein the recorded comments comprise subject matter of at least one of: a familiarity commentary, a clinical review of graphical records, a health parameter trend information, a behavioral parameter trend information, and a needed products available for purchase information.
19. The method of claim 17 wherein the recorded comments comprise subject matter of at least one of: a positive behavioral reinforcement, an educational information, a purchasing information, at least one suggestion for improved patient behavior, and at least one of: clues, recommendations, acknowledgements and replies.
20. The method of claim 17 further comprising the step of producing a video screen comprising a first portion of the video screen depicting the health status report and a second portion of the video screen, adjacent to the first portion, depicting the professional comments recording.
21. The method of claim 17 wherein the comments recording comprises at least one of: behavior reinforcing comments, educational comments, and reassurance comments wherein the comments recording is directed for improving patient behavior.
22. The method of claim 17 wherein the comments recording comprises a summary of the health status report including medical significance and recommended changes in patient behavior and medications.
23. The method of claim 17 wherein the comments recording comprises at least one of: recommendations, suggestions, encouragements, demands, and clues for patient purchases.
24. The method of claim 17 further comprising the step of incorporating into the video screen, a plurality of action initiating button icons, and the further step of integrating the button icons with actions related to choices presented in the professional comments recording.
25. The method of claim 24 wherein at least one of the action initiating button icons is enabled for at least one of: a video presentation of medical products and supplies recommended for purchase and an initiating video screen for the purchase of the medical products and supplies recommended in the professional comments recording.
26. The method of claim 24 wherein at least one of the action initiating button icons is enabled for restarting the professional comments recording.
27. The method of claim 24 wherein at least one of the action initiating button icons is enabled for transmitting a message to a medical professional.
28. The method of claim 17 further comprising the step of incorporating into the video screen, a graphical representation of a medical device, and the further step of integrating the button icons with actions related to operation of the medical device.
29. The method of claim 17 further comprising the step of producing a video screen comprising a graphical listing of a plurality of commercial medical products related to the health status report and the professional comments and a graphical means for selecting any of said products on the screen.
30. The method of claim 29 wherein the video screen producing step further produces a graphical selection means for selecting a method of billing.
31. The method of claim 17 further comprising the additional step of notifying the patient that a video report is available for viewing.
Claims (French):
Claims (German):
Claims (Spanish):
First Claim:
1. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medication storing means, a medication accessing means, a dispensed medication counting means, and a medical device wave energy communicating means; *
b) sequencing a counter of the dispensed medication counting means each time the medication accessing means is manipulated for access to the medication storing means; *
c) establishing a data set comprising each new numerical value of the counter and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
Independent Claims:
1. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medication storing means, a medication accessing means, a dispensed medication counting means, and a medical device wave energy communicating means; *
b) sequencing a counter of the dispensed medication counting means each time the medication accessing means is manipulated for access to the medication storing means; *
c) establishing a data set comprising each new numerical value of the counter and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
10. A method for improving patient compliance with a medical program, the method comprising the steps: *
a) providing a portable medical device means providing a medical state sensing means, a medical state value recording means, and a medical device wave energy communicating means; *
b) recording the medical state each time the medical state sensing means is manipulated for sensing the medical state; *
c) establishing a data set comprising each new value of the medical state and a corresponding time and date of the numerical value of the counter; *
d) repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period chosen to assure a selected probability of the receipt of said wave energy signal by a base station.
17. A method for creating video screens in a medical monitoring and control system comprising the sequenced steps: *
a) logging a sequence of health event data into a data storage means at each of a plurality of time dependent data logging events; *
b) transmitting each of a plurality of the sequence of health event data to a remote monitoring center in accordance with a preferred transmission schedule; *
c) merging the health event data of the several sequences of health event data as a non-redundant set of such health event data; *
d) producing a health status report in accordance with the non-redundant set of heath event data; *
e) evaluating the health status report; *
f) recording professional comments concerning the health status report as a video and audio presentation; and *
g) adapting the recording and the health status report for electronic transmission on demand.
Description:

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION:

This invention relates generally to the monitoring and control of medical care data by non-medically trained individuals, and more particularly to an automated method of collecting and using patient care data for assuring a high level of healthcare vigilance with feedback to the patient and the patient's caregivers, and with provision for professional medical advice including the selection of offered medications and other medical supplies for sale..

DESCRIPTION OF RELATED ART:

The following art defines the present state of this field:

Kutzik et al, U.S. 5,692,215 describes a system that provides for monitoring a user in a user living area. The system includes a system controller and an activity detection subsystem. The activity detection subsystem monitors a daily living activity of the user and provides information representative of the daily living activity to the system controller. The system controller includes a control circuit which generates a control signal in response to the daily living activity information obtained by the activity detection subsystem. Control information from the system controller is applied by way of a control information communication channel both to the activity detection subsystem and to a remote monitoring site. The activity detection subsystem may be system for determining the movement of the user around the home, medication compliance by the user, problems with usage for stoves or other potentially dangerous appliances, and selected auxiliary appliances.

Lipscher, U.S. 4,082,084 describes a portable diagnostic device, particularly for medical field-examinations comprising a case-like housing in which replaceable electronic examining units are arranged serving for the examination of different physiological functions and/or conditions. The housing comprises an electronic power supply feeding each of the electronic examining units, a common display receiving the output signals of the examining units and electrical connectors providing electrical connections between the housing and each of the examining units. The inner room of the housing is divided into two separate parts, the first of which is arranged in a modular system and accommodates slide-in examining units, while the second part serves to accommodate the accessory means required for the examinations.

Fu, U.S.4,803,625 provides for a personal health monitor which includes sensors for measuring patient weight, temperature, blood pressure, and ECG waveform. The monitor is coupled to a central unit via modems and includes a computer which is programmed to prompt a patient to take prescribed medication at prescribed times, to use the sensor to measure prescribed health parameters, and to supply answers to selected questions. Medication compliance information, test results, and patient answers are compiled in a composite log which is automatically transmitted to the central unit. The computer is also programmed automatically to disconnect the monitor from an alternating current power source and to rely on internal battery power during certain periods of patient monitor interaction, such as during use of the ECG module. In this way, danger to the patient and complexity of the ECG module are minimized. The computer is also programmed to compare measured test information with predetermined expected values, and in the event of a discrepancy, to collect additional information from the patient to assist trained personnel at the central unit in interpreting the composite log. The computer is also programmed to alert the central unit promptly in the event one or more measured parameters falls outside of a prescribed normal range. The normal range for a given parameter is made to vary in accordance with the measured value of one or more other parameters in order to reduce the incidence of false alarms.

Bornn et al., U.S. 4,827,943 provides a link between the caregiver and the subject being monitored which utilizes an intermediate base station with redundant signal paths between the base station and the caregiver. The caregiver wears a unit which receives signals from the base station. Signals from the base station provide information about the subject being monitored and provides signals for use in determining whether the caregiver remains within the range of the base station. The unit worn by the subject being monitored can include diagnostic circuitry for evaluating signals received from sensors to transmit an alarm signal to the base stations when the subject being monitored is in need of assistance. A range monitoring system is provided which alerts the subject being monitored as well as the caregiver whenever the subject being monitored moves outside the range of the base station.

Kaufman, U.S. 4,933,873 describes an interactive patient assistance device which houses both pre-selected doses of medication and a physical testing device. Both medication and the testing device are normally retained within separate compartments within the device away from access by the patient. The device keeps track of medication and diagnostic testing schedules. The device is also capable of receiving and interpreting verbal commands of the patient. The device makes a pre-selected dose of medication available to the patient in response to either the medication schedule or the receipt of a verbal command by the patient. Likewise, the testing device is made available to the patient in response either to the testing schedule or the receipt of a verbal command from the patient.

Treatch, U.S. 5,007,429 describes a user interface for directing the programming of operating parameters for patient blood pressure testing into and downloading blood pressure data from ambulatory patient blood pressure monitoring units. The user interface operates on a system comprising a plurality of microprocessor based, ambulatory blood pressure measuring patient units, an office control unit, and a data processing center, typically accessed over telephone lines. An office control unit is used to program patient units with test regimens for specific patients. The control units are also used to download data from the patient units and to transfer the data, along with patient identifying data, to the central data processing facility. The office control unit includes local memory which stores various interface routines, a microprocessor for executing the routines, a 12-character keypad allowing input of integers and a display for displaying prompts to the user. Upon initial power up of the control unit, and operator using the control unit is prompted through a start up sequence and a menu selection sequence to carry out the desired functions of the system. All selections are made, and all operating parameters are entered, through a telephone like keypad. The display indicates to the user which parameter entry of which is called for and which menu items are available for selection. During transfer of data to the central processing facility, additional prompts may be given to the operator by voice over the telephone handset.

Blomquist, U.S. 5,338,157 describes an invention relating to systems and methods for communicating with ambulatory medical devices, such as drug delivery devices, both locally and remotely. In one embodiment, a caregiver drug pump communicates with a remote patient drug pump for data gathering, trouble shooting, and operational program changes. The caregiver drug pump is at least substantially identical in configuration to the patient drug pump. The caregiver drub pump transmits caregiver key input signals to the remote patient drug pump. The patient drug pump receives the key input signals, accesses a desired program, and transmits information for display on the display of the caregiver drug pump. In another embodiment, a computer is provided for communicating locally and/or remotely with a drug pump. The computer may include a display with an image of a pump. The computer may be operated through the use of a mouse or touch screen with respect to the image of the pump, to simulate use of the pump while using the personal computer. The computer may also be used as a training aid for training a caregiver and/or patient how to use the drug pump.

Maestre, U.S. 5,347,453 describes a portable programmable medication device for aiding in the administration of medication or pharmaceuticals in accordance with a prescribed medication dosage schedule. In a first illustrative embodiment, the programmable medication alarm device is manually programmed with data representative of a prescribed medication dosage schedule specifying a prescribed administration time, dosage amount, administration route, and medication instructions for each medication dosage to be administered to the patient. In response to the time occurrence of each programmed administration time, and audible dosage alarm signal is generated and graphical representations of the prescribed administration time, dosage amount, administration route and medication instructions are visually displayed in predefined visual display fields. In a second illustrative embodiment, the portable medication alarm device is programmed by loading the prescribed dosage schedule data from a computer system, into the memory of the medication alarm device, using an automated data communication process. Also disclosed is a medication container holder which attaches the programmed medication alarm device to a conventional medication container, such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle, without interfering with the operation thereof.

Stutman, U.S. 5,416,695 describes a medical alert system which enables an authorized user, such as a doctor, to remotely set selection and limit parameters pertaining to specific medical and geodetic information of an ambulatory patient and thereater received updates of that information over a wireless communication network when the parameters have been met. A telemetry device attached to the patient provides an inbound stream of medical and geodetic information to a host computer, which is configured to exact selected portions of that information in response to the parameters provided by a remote processing device via a communications network. Upon completion of the latter process, the host computer transfers the extracted information to the remote processing device over the network, thereby informing the doctor of a medical situation.

Maestre, U.S. 5,495,961 describes a portable programmable medication alarm device for aiding in the administration of medication or pharmaceuticals in accordance with a prescribed medication dosage schedule. In a first illustrative embodiment, the programmable medication alarm device is manually programmed with data representative of a prescribed medication dosage schedule specifying a prescribed administration time, dosage amount, administration route, and medication instructions for each medication dosage to be administered to the patient. In response to the timed occurrence of each programmed administration time, an audible dosage alarm signal is generated and graphical representations of the prescribed administration time, dosage amount, administration route, and medication instructions are visually displayed in predefined visual display fields. In a second illustrative embodiment, the portable medication alarm device is programmed by loading the prescribed dosage schedule data from a computer system, into the memory of the medication alarm device, using an automated data communication process. Also disclosed is a medication container holder which attaches the programmed medication alarm device to a conventional medication container, such as an eye-drop dispenser bottle, nasal-spray canister or pill bottle, without interfering with the operation thereof.

Vasko, U.S. 5,573,506 describes a remotely programmable infusion pump with interactive voice response via touch-tone phone (i.e., voice mail system in IV pump). The remotely programmable infusion system also comprises a voice storage unit for storing the voice signal. The remotely programmable infusion system further comprises a processor, coupled to the remote communication port, to the voice storage unit, and to the memory, for accessing the voice signal from the voice storage unit and the programmable protocol from the memory, and for processing the programmable protocol in response to receiving the remote programming signal.

Kurtenbach, U.S. 5,582,323 describes a medication dispensing and monitoring system of a present invention includes a housing containing a plurality of pill dispensing compartments for dispensing medication to a patient at a desired time. The invention is programmed to dispense medication at the desired time and activates alarms if the proper procedure is not completed. The invention also contacts the emergency personnel through phone lines and initiates two-way hands free communication between the patient and emergency personnel.

The invention further includes a pendent transmitter worn by the patient to contact emergency personnel.

Hultman, U.S. 5,582,593 describes an ambulatory medication delivery system which includes an ambulatory pump unit having a computer control linear motor pump for pumping predetermined volumes of fluid in accordance with a programmed delivery schedule which may be altered through communication with a remote monitoring location via a telephone data access line or via radio frequency communication. A clinician communication unit and a patient communication unit receive and send information to the ambulatory pump unit and also communicate via a telephone data modem access to the computer at a remote monitoring location at which trained health personnel can monitor a number of patient locations and alter or change medication delivery profiles as required.

Tacklind, U.S. 5,704,366 describes a system for monitoring and reporting medical information includes a stand-alone monitor for storing data records comprising measured values and time stamps and for transmitting the records to a remote reporting unit over a communication system. The remote reporting unit includes a relational data base that is updated when records are downloaded from the monitor; a report generator for generating chronological graphs of the measured values for a particular patient; and a report transmitting unit for transmitting reports to a requesting health care provider.

Ridgeway, U.S. 5,710,551 describes a system for the remote monitoring of in-home self-medication to assure compliance with prescribed dosage schedules. The system comprises at least one subscriber home medication station which interfaces with a communications link and a remote central monitoring station also interfaced with the link and operative to receive and analyze messages transmitted by the home medication station. The preferred home medication station embodiment transmits messages to the central station over the communications link each time the home medication station is accessed for a dosage of medication. Central station computer means verify receipt of such signals within each subscriber's uniquely scheduled dosage time windows, and alert an operator to take appropriate action if a dosage schedule error is detected. Alternative home medication station embodiments utilize a built-in programmable timer module to verify accessing of medication within a subscriber's uniquely scheduled dosage time windows, and to initiate transmission of alarm signals to the central station over the communications link if dosage schedule errors are detected by the timer module. All embodiments provide subscribers with help-button means to initiate transmission of alarm messages to the central station over the communications link in event of adverse reaction to medication, or other emergencies. Since the central station will be alerted if any scheduled dosage is missed, no emergency rendering a subscriber unable to press a help-button or call for help can go undetected longer than the maximum time between consecutively scheduled dosages.

Tacklind, U.S. 5,752,709 describes a system for monitoring and reporting medical information includes a stand-alone monitor for storing data records comprising measured values and time stamps and for transmitting the records to a remote reporting unit over a communication system. The remote reporting unit includes a relational data base that is updated when records are downloaded from the monitor; a report generator for generating chronological graphs of the measured values for a particular patient; and a report transmitting unit for transmitting reports to a requesting health care provider.

Stoop, U.S. 5,767,791 describes a two-way telemetry system which displays and monitors physiologic and other patient data of multiple, remotely located patients at a central location. The system comprises multiple battery-powered remote telemeters, each of which is worn by a respective patient, and a central station which receives, displays, and monitors the patient data received from the remote telemeter. The telemeters communicate with the central station using a two-way TDMA protocol which permits the time sharing of timeslots, and which uses a contention slot to permit telemeters to transmit service requests to the central station. Two-way special diversity is provided using only one antenna and one transceiver on each remote telemeter. The remote telemeters include circuitry for turning off the active transceiver components thereof when not in use (to conserve battery power), and include circuitry for performing a rapid, low-power frequency lock cycle upon power-up.

The system has multiple modes of operation, including a frequency hopping (spread spectrum) mode and a fixed frequency mode, both of which preferably make use of the 902-928 MHz ISM band. Patient locators are provided to allow the clinician to track the location of each patient.

Russo, U.S. 5,807,336 describes a medical apparatus that is provided with a programmable medical device disposed at a first room location and a remote monitor and/or controller disposed at a second room location. The programmable medical device is used to administer a medical treatment to a patient, and the remote monitor/controller may be used to monitor the operation of the medical device, control the operation of the medical device, and/or transfer data from the medical device to the remote monitor/controller. The apparatus may allow voice communication between the remote monitor/controller and the patient who is receiving treatment via the medical device while the medical device is being monitored and/or controlled from the remote location. The remote monitor/controller may also include means for determining the type of medical device to which it is connected.

Brudny et al., U.S. 5,810,747 describes an interactive intervention training system used for monitoring a patient suffering from neurological disorders of movement or a subject seeking to improve skill performance and assisting their training. A patient (or trainee) station is used in interactive training. The patient (or trainee) station includes a computer. A supervisor station is used by, for example, a medical or other professional. The patient (or trainee) station and the supervisor station can communicate with each other, for example, over the Internet or over LAN. The patient (or trainee) station may be located remotely or locally with respect to the supervisor station. Sensors collect physiologic information and physical information from the patient or subject while the patient or subject is undergoing training. This information is provided to the supervisor station. It may be summarized and displayed to the patient/subject and/or the supervisor. The patient/subject and the supervisor can communicate with each other, for example, via video, in real time. An expert system and neural network determine a goal to be achieved during training. There may be more than one patient (or trainee) station, thus allowing the supervisor to supervise a number of patients/subjects concurrently.

The prior art teaches the use of electronic measuring and monitoring of patients. However, the prior art does not teach that an automated medication and monitoring system with feedback can be used with such a method that data completeness and accuracy is assured through a novel signal repetition protocol. Also, the prior art does not teach that reporting of health results to the patient may be done in an interactive manner coupled with professional medical advisers helping, through a novel remote communication protocol, to direct optimum patient behavior, including offering of medical supplies and medications associated with an ongoing management program. The present invention fulfills these needs and provides further related advantages as described in the following summary.

SUMMARY OF THE INVENTION

The present invention teaches certain benefits in data handling methods which give rise to the objectives described below.

The present invention provides a home care medical data logging, communication, and reporting method that has not been described in the prior art.

A primary objective of the present invention is to provide such an method having advantages not taught by the prior art and which are capable of accurate medical data recording especially for a non-compliant patient.

Another objective is to provide such a method capable of assuring the transmission of accurate medical data although a patient is not within data transmission range of a data receiving station for significant periods of time.

Yet another objective is to provide such a method having means of correlating and reporting health and behavioral status on an interactive basis so as to improve compliance by a reluctant patient.

A further objective is to provide such a method enabled for offering and motivating a patient to purchase supplies and medications in accordance with a medical care program.

Other features and advantages of the present invention will become apparent from the following more detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings illustrate the present invention. In such drawing: *
FIGURE 1 is a schematic block diagram showing the relationship between major elements of the invention; *
FIGURE 2 is a schematic block diagram of a typical dispensing device thereof; *
FIGURE 3 is a typical printed report of the invention illustrating medication dosing compliance correlated to patient status; *
FIGURE 4 is a typical monitor screen display report of the invention illustrating dosing compliance correlated to patient status; *
FIGURE 5 is a typical monitor screen display report of the invention illustrating oral medication compliance; *
FIGURE 6 is a typical monitor screen display report of the invention illustrating daily sugar level variation for a diabetes patient and showing the measurement device therefor; *
FIGURE 7 is a typical monitor screen display of the invention for inputting patient care orders for, in the present case, medication instructions; and *
FIGURE 8 is a typical monitor screen display of the invention illustrating a method of delivering health or behavior information with a nurse, clinician or other helper providing audio and video transmission of explanations, information, feedback, suggestions, instruction on ordering medication refills and supplies, behavior modification and control and other invention pertinent communications.

DETAILED DESCRIPTION OF THE INVENTION

The above described drawing figures illustrate the invention, a system including apparatus and method, for improving patient compliance with a medical program. The medical program may include medication dispensing elements as well as medical state sensing elements or both. The invention is used to monitor and modify medical care and especially patient behavior patterns associated with medication dispensing, medical state sensing and patient behavior with respect to acquisition and maintenance of medical treatment related supplies, wherein the apparatus comprises: a portable medical device means 10 providing, in one embodiment, a medication storing means such as a pill bottle, a medication accessing means such as the cap to the pill bottle, a dispensed medication counting means such as an electronic flip-flop counting circuit 40 with a simple numerical indexer, preferably powered by a battery Bl, in communication with the pill bottle cap by any electromechanical, magnetic or other physical element known to one of skill in the art and represented by letter "M" in Figure 2, such that when the cap is removed from the pill bottle, a switch S1 is made such that the circuit counting means indexes to a next higher numerical value, and a medical device wave energy communicating means such as a radio transceiver 50 is activated. The portable medical device means 10 may include a single dispensing and counting unit or multiple units, and further may include a single counting unit for multiple dispensed items, or multiple counting units (for redundancy) for a single dispensed item; the dispensed medication counting means being enabled for sequencing the counting circuit 40 each time the medication accessing means is manipulated, for gaining access to the medication storing means, the device means 10 being further enabled by a logic circuit 60 for establishing a data set comprising, for example, the current numerical value of the counting circuit 40 and a corresponding time and date of the sequencing of the counting circuit 40 as through the use of a clock circuit 70, the wave energy communicating means 50 being enabled by a control program in the logic circuit 60, for example, for repetitively transmitting, as for example, every 30 minutes, a wave energy signal corresponding to each newly established data set during a selected period of transmission time, as for example 72 hours, the transmission time period being chosen to assure a selected probability of the receipt of said wave energy signal by a base station 20 which is remotely located with respect to the medical device means 10 but which is within practical wave energy receiving range frequently. Because the transmission range of the transceiver is limited by FCC rules, it is conceivable, and quite common for the portable medical device means 10 to be carried by the patient to a location that is not within the range of the base station 20. This would happen on a regular basis if, for instance, the patient was in the habit of taking a walk in the park between 2 PM and 4 PM each day and carries his pill bottle so as to be able to take his 3 PM pills. This dosage would be counted when the pill bottle cap is removed, but could not be received immediately at the base station 20 since the pill bottle would be out of range at that time.

In another embodiment the invention comprises: the portable medical device means 10 providing a medical state sensing means and the medical device wave energy communicating means 50 of the first embodiment; the medical state sensing means is enabled for sensing a medical state variable, such as body temperature, body weight, blood pressure level, or blood glucose level each time the sensing means, i.e., thermometer, weight scale, sphygmomanometer or blood glucose measurement system, respectively, is manipulated in accordance with any well known medical state variable manipulation protocol, i.e., common to any medical examination office or clinic, and further enabled, by a simple mechanical arrangement "M" such as the use of a sensor for sequencing the electronic counter 40, as described above, each time the sensing means is manipulated and for establishing a data set comprising a value of the measured medical state, a numerical value of the counter 40 and a corresponding time and date of the measurement from the clock circuit 70, the wave energy communicating means 50 being enabled, as above, for repetitively transmitting a wave energy signal corresponding to each newly established data set for a selected period of transmission time, the transmission time period, again, being chosen to assure a selected probability of the receipt of said wave energy signal by the base station 20 as previously described.

In either embodiment, the invention further preferably comprises a human responsive signaling means, such as an audible alarm or a vibration generating device (not shown), enabled in accordance with the patient's medication and state measurement schedule, referred to below as the "medical schedule," to alert the patient when medication dosing or medical state sensing is required. Such audible and vibration alarms, i.e., attention demanding techniques, are well known in the personal pager industry.

Preferably, the base station 20 comprises a base station wave energy communicating means, such as a radio transceiver 50 similar or identical to that of the medical device means 10, and is preferably physically located in the patient's home for example, for enabling reception of at least one repetition of the wave energy signal of the medical device wave energy communicating means 50 and also for transmitting the medical schedule to the medical device means 10, the base station 20 further providing a primary, two-way communicating means 90 shown in Figure 1, such as a telephony or other communication means, enabled by logic circuits and software programming, as is well known in systems engineering, for automatically transmitting the data set values of the medical device means 10, as received via the wave energy signal, in accordance with a selected communicating schedule. That is to say, the information received at the base station 20 from one or more of the portable medical device means 10 is transmitted via the two-way communicating means 90 to a remote monitoring station 30, the remote monitoring station 30 further comprising a computation means, such as a general purpose computer, for computing summary information of interest to medical professionals and caregivers and the patient him/herself, such as a correlation analysis between the received data set values and a selected medical state parameter that is being monitored, the remote monitoring station 30 comprising further enablement, by modem or other means, for transmitting information of interest to the primary, two-way communicating means via the secondary, two-way communicating means 90 and for transmitting the selected medical schedule, usually a schedule defined by a primary medical care giver such as the patient's medical doctor. Preferably the base station 20 receives a unique identification code "PB187" representing "pill bottle 187" or "BPM456" representing blood pressure monitor 456," and "1030A-120198" representing a time-date stamp corresponding to, 10:30 AM on Dec. 1, 1998, and, in the case of a medical state measurement, additionally a measured value code such as "125/80" representing blood pressure levels at the time and date of the measurement. Such a transmission would therefore be coded as "BPM456. 1030A-120198.125/80" and may be transmitted in binary coded decimal form or converted to digital form prior to transmission. Other transmissions from the various medical device means 10 may include a low battery status, out of medication, or other supply, "active," "standby," or "inoperative" status, etc. along with the time/date identification. The software protocol used in the medical device means 10 or in the base station 20, or both, is preferably configured for identification of an emergency state, as when blood pressure or glucose level are at a dangerous level. In this case the medical device means 10 will immediately set an audible or other alarm to request a repeat of the measurement by the patient or his caregiver. In the following, and clearly throughout this description and the claims that follow, the use of "patient" should be recognized as including the actual patient, or his immediate caregiver such as a family member or a care provider such as a practical nurse or a medical worker. It is intended that preferably the patient will be active with respect to the present invention, at least in part, but if the patient is not active, a caregiver acts for the patient and as such, the caregiver must be at least frequently in close proximity to the actual patient.

The base station 20 is configured to immediately send an alarm message to the remote monitoring station 30 for immediate authoritative supervision and decision making, etc. The means for accomplishing these results, i.e., enablement, is most efficaciously completed through software logic programs controlled by microprocessor means within the medical device means 10 and the base station 20 means. Such enablement is considered to be within the ability of those of average skill in the art, and are therefore not defined here in further detail.

Clearly, the portable medical device means 10 may be any one or more of the well known dispensing devices in use in pharmacy and medicine such as an inhalant dispenser, an intravenous dispensing system, an oral or anal medication dispenser, a topical formulation dispenser, etc., for dispensing a selected dosage of a medicinal inhalant, intravenous medication, medicaments formulated as pills, capsules, caplets or other forms of solid medications or liquid or other forms of internal medications, as well as topical formulations. In each case the medication accessing means, such as a bottle cap, a dispensing tube winder, an inhalant pump, or a IV flow meter, is adapted by any simple well known sensing arrangement to trigger the counting means while simultaneously dispensing a previously selected dosage of the medication. Alternately, the dispensed amount may be controlled by the patient or the on-site caregiver.

In the preferred embodiment the medical device wave energy communicating means 50 of the medical device means 10 is adapted for accomplishing certain inventive methods, through any common or well known data manipulation process for receiving and implementing the medical schedule as transmitted from the base station 20, a simple matter of data transmission and receival. In this manner, the medication or state sensing schedule is remotely set-up within a memory device or circuit 80 of the medical device means 10, and may also be changed at any time. Also, the remote monitoring station 30 is adapted by these methods, i.e., simple tracking protocols, for composing a refill request message, at appropriate times when its calculations show that supplies are low, and for transmitting the refill request message to the base station 20 to alert the patient by, for instance, illuminating a lamp or presenting a written message on an LCD, or similar display on the base station, and, or on the medical device means 10.

Preferably, the methods of the present invention are adapted for composing graphical summary reports showing, for instance, when each medication was, in fact, taken and when each medical measurement was, in fact, completed. Such a history of events may be for a week, month or longer so as to enable the patient to see trends. The portable medical device means 10 of the invention is enabled, by memory device 80, for storing a list of all said data sets established over the selected period of transmission time, e.g., 72 hours, the list being transmitted repetitively at a selected frequency of transmission, e. g., every 30 minutes, so as to improve, through transmission redundancy, the probability of receipt, by the base station 20, of all data sets established by the medical device means 10. In the preferred embodiment, each of the data sets is paired with a check-sum and with a CRC, the base station 20 providing check-sum and CRC error-reducing protocol operating on the data sets as received for providing error reduction. These error checking protocols are well known, but have not been previously used in the field of the present application, and are certainly critically important in the present use.

In use, the patient notifies the remote monitoring center as to the master medical schedule for medications and/or medical state measurements required. This may be accomplished by telephone, fax, written communication, or internet screen, the latter being illustrated in Figure 7. A database is established at the remote monitoring center for the patient. The master medical schedule information is downloaded to the base station 20 through the primary and the secondary communicating means, generally via telephony. The base station 20 then transmits an appropriate portion of the master medical schedule to each of the medical device means 10 which will be used by the patient. Each of the medical device means 10 then alerts the patient when a medication or a measurement should be taken. The medical device means 10 continues to remind the patient that such event is required until it is accomplished. The fulfillment of each event is recorded as described above and entered into the event list. The entire list is transmitted to the base station 20, as defined above, every selected period, such as every 30 minutes over a time duration of 72 hours for example or other selected duration. Each time the list is received by the base station 20 it is compared with the resident list at the base station 20 and any blanks in the resident list are filled-in from the newly received list. The duplicate entries are then discarded so that the resultant list is complete and non-redundant.

The invention further provides a reporting function which is illustrated in Figures 3-6 and 8. Figure 3 illustrates a correlation report which may be used to highlight the importance of behavioral compliance with a medication schedule for maintenance of a health parameter, such as blood pressure level or blood glucose level. Individual data reports are well-known in the medical industry, but graphical reports of patient behavior versus one or more health statistics, as defined by a chart, such as a bar chart, is novel and considered distinct from the prior art.

Once the reports are generated by the remote monitoring station 30, they are delivered to the patient, to enable action to be taken. Delivery modalities include hardcopy paper reports sent by mail delivery, faxed copies, or internet web-page delivery. The internet web-page delivery is preferred because it economically allows the use of color graphics. Color might be used in Figures 4 and 5, for example, to highlight deviations from the scheduled dosage time such that missed dosages or delayed dosages are shown in red and on-time dosages are shown in green. Highlighting good and bad behavior patterns to the patient is functional for establishing improved behavior.

Figure 4 illustrates the use of reports similar to Figure 3, but in a web-page format. Often patients become confused when they must use many different of the medical devices means. Figure 6 illustrates how information can be more readily associated with a specific device to enhance patient recognition and understanding, i.e., the inclusion of a picture of the device the patient is using. Figure 6 also shows controls (screen buttons) whereby the patient or local caregiver may send commands pertaining to device settings directly to the remote monitoring station 30. The remote monitoring station 30, in turn, is enabled for relaying these control messages to the base station 20 located in the patient's residence. In this manner, the web-page format is used to provide the patient with information and can also be used by a clinician at a remote location to control a patient's instruments, for example, based upon the health data statistics that are compiled.

Figure 7 illustrates how the web-page format can be entirely dedicated to the setup and control of a medical device means 10, such as a medication dispenser. In Figure 7, a clinician at the remote monitoring center or at any remote location can enter dosing related information and instructions and the medical schedule for that medication dispenser.

Figure 8 illustrates an advance in the reporting of medical information to patients. The advance includes the correlation of two or more behavior and/or health data graphics which are constructed from actual measurements of the patient's compliance or health statistics. Further, the report includes a human image and related spoken message which is preferably a video message but may be live. This human image is preferably a clinician, such as a nurse, but may also be a doctor or other primary caregiver. As stated, the message may be delivered in real-time, but is preferably delivered in a stored format, such as by e-mail or a stored streaming video, so that the patient may view it or replay it more than once, at his or her convenience. Such replay is facilitated by a dedicated replay button as shown in the figure. The video message report may include elements of encouragement, education, information, reinforcement, or reprimand, as may be needed to modify the behavior of the patient to comply with instructions. Such elements may further include a list of items which the patient may need or want to purchase or otherwise obtain, such as medication refills, information flyers, insurance information, and miscellaneous items such as flowers, greeting cards, etc. for improving the patient's morale.

The reports are preferably interactive so as to enable the patient to easily reply to questions or ask questions via a dedicated contact button. Such a button will, in one embodiment, activate an e-mail reply screen, as is well-known, that may generate text, voice or video image formats for composing a reply message. Further, the report includes purchasing reminders, clues or requests made by the clinician image, such as to remind the patient to purchase refills on medication or medical device supplies, such as blood glucose monitoring test strips, to order home supplies such as flowers, books, videos, music recordings, or other household goods, or to order new equipment such as an additional pill bottle for a new medication. Even further, the report allows the patient to respond to such reminders, clues or requests via a "place order" button, as illustrated. The place order button, depending upon the type of account established with the remote monitoring center, and may immediately fulfill the order suggested by the video image or it may lead to order selection and confirmation screens, as is well-known in the art. The interactive report may further include an invitation to reply to any questions posed by the clinician image, or to pose new questions to the clinician image, or to respond to previous questions posed by the patient to the clinician image. Additionally, the clinician image may suggest that the patient replay the video message to reinforce an understanding of its contents. The use of interactive reports as defined herein is considered novel in the present field, so as to distinguish over the prior art.

The following charts define: the preferred manner in which the video reports (screens) are created, preferred screen content, how the screens are used and preferred follow-up action. Please note the use of B-S representing "base station 20" and M-C representing "remote monitoring station 30."

From the diagrams above it is seen that the present invention provides for a method for creating video screens in a medical monitoring and control system comprising the sequenced steps: *
a) automatic logging of health event data from dispensing devices and/or medical state measurement devices, into a storage means at the time of such events as enabled by actions of a patient or a patient with the help of a caregiver usually in the patient's home; *
b) automatic transmitting of the health event data to a local base station for storage therein, the base station being generally in the patient's home; *
c) automatic transmitting of the health event data on a predetermined schedule to a remote monitoring center for storage therein, the center being located outside the patient's home and usually in a distant location, possibly near a hospital or doctor's office; *
d) automatic merging of each new transmission of the event data with an existing record of all previously recorded event data from the same base station; *
e) deleting duplicate entries of the event data; *
f) retrieving the event data as an event data report comprising charts, graphs, etc.; *
g) medical personnel evaluating of the event data report; *
h) medical personnel recording of comments concerning the event data report, the comments comprising familiar commentary, clinical review of graphical records, health parameter trend information, behavioral parameter trend information, positive behavioral reinforcement, educational information, purchasing information, suggestions, clues and recommendations, acknowledgements and replies, and recommendations; *
i) transmitting or sending the recorded comments of step (h) to storage for saving in multimedia format; and *
j) sending the recorded comments of step (i) to the caregiver upon his/her demand. *
k) caregiver viewing of the recorded comment and lists of alternative supplies and refills; *
1) caregiver placing orders for suggested supplies and refills of medications; and *
m) caregiver sending an electronic message to a medical personnel.

Clearly, the above method is facilitated by wireless communication, land line wire based communication and networked communication methods of well known types such as radio, telephone and Internet links, hook-ups, and other enablements.

As an example of the type of prerecorded information presented in a medical consultation style the follow