Programmable infusion pump

• US 4,741,736 A
• Filed: 12/10/1986
• Issued: 05/03/1988
• Est. Priority Date: 12/10/1986
• Status: Expired due to Term

• Current Assignee: I-Flow Corporation (Kimberly-Clark Corporation)
• Original Assignee: I-Flow Corporation (Kimberly-Clark Corporation)
• Inventors: Brown, Eric W.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Kartchner, Gene B.
• Application Number:
  US06/940,044
• Time in Patent Office: 510 Days
• Field of Search: 604/7, 604/67, 604/65, 604/153, 604/131, 604/134, 604/135, 604/151, 604/154
• US Class Current: 604/134
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/148 flexible, e.g. independent bagsA61M5/155 takes precedence
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

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.

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.

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.