Fluid handling system for medication infusion system

• US 4,525,165 A
• Filed: 11/04/1982
• Issued: 06/25/1985
• Est. Priority Date: 04/27/1979
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University of Baltimore Maryland
• Original Assignee: Johns Hopkins University
• Inventors: Fischell, Robert E.
• Primary Examiner(s): Howell, Kyle L.
• Assistant Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/439,138
• Time in Patent Office: 964 Days
• Field of Search: 604/890, 604/891, 604/141, 604/48-49, 604/4, 604/65-66, 604/131, 128/DIG. 12-DIG. 13
• US Class Current: 604/131
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

An apparatus for fluid handling and delivery in a medication infusion system is disclosed. The apparatus generally contains a pulsatile pump in combination with at least an accumulation flow restrictor. The pulsatile pump is economical in electrical consumption by virtue of the use of a spring force pumping action. The accumulator flow restrictor smooths the output from the pulsatile pump so that medication is delivered in a manner compatible with human or animal body needs. As an example, for infusion of medication such as insulin, the medication infusion system can provide an infusion flow profile which mimics that of insulin production in a normal person.

Claims

1. An infusion apparatus for providing medication to a living body of a patient comprising:

a medication reservior for storing selected medication;

means for pumping said selected medication responsive to actuating commands for pumping fixed volume pulses at a variable rate, said pump means operating in a pulsatile mode, the input of said pump means being in communication with said reservior;

means for actuating said pump means at a variable rate;

means for accumulating said selected medication, said means for accumulating comprising a variable volume chamber, the input of said accumulator means being in communication with the output of said pump means whereby said accumulator means may be filled at a variable rate governed by said pump means;

means for restricting the flow of said selected medication, the input of said flow restrictor means being in communication with the output of said accumulator means, said flow restricator means in combination with said accumulator means smoothing the pulsatile nature of the flow of said selected medication; and

means for communicating said selected medication from the output of said flow restrictor means to said living body.

2. An apparatus in accordance with claim 1, wherein said variable volume chamber includes means for providing a deformation force for returning said chamber to a preselected minimum volume when at rest, filling of said variable volume chamber causing the expansion thereof.

3. An infusion apparatus in accordance with claim 1, wherein said variable volume chamber includes means for providing a deformation force for returning said chamber to a preselected minimum volume when at rest, filling of said variable volume causing the expansion thereof, said deformation means having a first spring constant during a first selected range of volumes and a second spring constant during a second selected range of volumes.

4. An infusion apparatus in accordance with claim 3, wherein said first spring constant is smaller than said second spring constant, said first selected range of volume being smaller than said second selected range of volume, said accumulator means in combination with said flow restrictor means therefore having a time constant which is longer for said first selected range of volumes than the time constant for said second selected range of volumes.

5. An infusion apparatus in accordance with claim 4, wherein said accumulator means comprises at least one flexible wall having an inherent spring constant as said deformation means having a first spring constant;

and, spring means mounted adjacent to said flexible wall as said deformation means having a second spring constant such that a preselected amount of flexing of said wall upon filling of said variable volume chamber causes contact of said flexible wall with said spring means, said spring means having a spring constant higher than said inherent spring constant of said flexible wall, said flexible wall effectively having a greater spring constant when in contact with said spring means.

6. An infusion apparatus in accordance with claim 5, further comprising means for referring said flexible wall to the ambient pressure of said living body.

7. An infusion apparatus in accordance with claim 1, further comprising a second accumulator-flow restrictor assembly including another means for accumulating said selected medication and another means for restricting the flow of said selected medication, the output of said another accumulator means being in communication with the input of said another flow restrictor means, said another flow restrictor in combination with said another accumulator means smoothing the pulsatile nature of the flow of said selected medication as a result of said at least one accumulator-flow restrictor assembly being interposed between the said restrictor means and said communication means, the input of said another accumulator means being in communication with said output of said restrictor means, said communication means communicating said selected medication from the output of said another flow restrictor means to said living body.

8. An infusion apparatus in accordance with claim 7, wherein both said accumulator means each comprise a variable volume chamber including means for providing a deformation force for returning said chambers to a preselected minimum volume when at rest, filling of said variable volume chamber causing the expansion thereof, said deformation force means having a first spring constant during a first selected range of volumes and a second spring constant during a second selected range of volumes.

9. An infusion apparatus in accordance with claim 8, wherein said first spring constant of said accumulator means is smaller than the second spring constant of said accumulator means, and the first spring constant of said another accumulator means is smaller than the second spring constant of said another accumulator means, said first selected range of volumes of said accumulator means being smaller than said second selected range of volumes of said accumulator means, said first selected range of volumes of said another accumulator means being smaller than said second selected range of volumes of said another accumulator means, each of said accumulator means in combination with the associated said flow restrictor means having a time constant which is longer for volumetric displacements in each of said first selected ranges of volumes than the time constant for volumetric displacements in each of said second selected ranges of volumes.

10. An infusion apparatus in accordance with claim 9, further comprising means for referencing at least one of said accumulator means to the ambient pressure of said living body.

11. An infusion apparatus in accordance with claim 1, wherein said pump means comprises a bellows chamber means for storing said selected medication within said pump means, an increase in volume of said bellows chamber means permitting drawing of said selected medication through said input of said pump means into said bellows chamber means, a decrease in volume of said bellows chamber means permitting expulsion of said selected medication out of said bellows chamber means through said output of said pump means.

12. An infusion apparatus in accordance with claim 11, further comprising an input pressure valve and an output pressure valve, each of said pressure valves being normally closed, said input pressure valve being disposed between said pump means input and said bellows chamber means, an increase in volume of said bellows chamber means causing said input pressure valve to open and said selected medication to enter said bellows chamber means, a decrease in volume of said bellows chamber means causing said output pressure valve to open and said input pressure valve to close, so as to permit said selected medication to enter said input of said accumulator means as a pressure pulse.

13. An infusion apparatus in accordance with claim 12, wherein said bellows chamber means comprises at least one flexible wall, movement of said flexible wall varying the volume of said bellows chamber means, and means for moving said flexible wall.

14. An infusion apparatus in accordance with claim 13, further comprising spring means for urging said flexible wall in a manner which decreases the volume of said bellows chamber means, the magnitude of the force applied to and stored by said spring means increasing as the volume of said bellows chamber means increases due to the displacement of said flexible wall thereof by said moving means.

15. An infusion apparatus in accordance with claim 14, wherein said flexible wall serves as said spring means.

16. An infusion apparatus in accordance with claim 15, wherein said flexible wall has a surface in contact with said selected medication which can be drawn into said bellows chamber means.

17. An infusion apparatus in accordance with claim 16, wherein said flexible wall is attached to a magnetizable plate, said moving means comprising a coil disposed proximate to said plate, said coil selectively causing a pulsing magnetic field, pulsing of said coil causing said plate to be moved.

18. An infusion apparatus in accordance with claim 17, wherein said flexible wall of said bellows chamber means is inhibited from moving when the pressure (P) in said bellows chamber means exceeds the spring force (F) of said flexible wall divided by the effective area (A) of said surface of said flexible wall in contact with said selected medication, that is when P_max =F/A and wherein said restricting means will then limit the flow to a selected maximum level when said coil is pulsed too rapidly, thereby providing a safety feature.

19. An infusion apparatus in accordance with claim 17, wherein said plate comprises a magnetizable magnetic armature.

20. An infusion apparatus in accordance with claim 15, further comprising means for limiting the distance said plate can move in both a volume increasing direction and a volume decreasing direction.

21. An infusion apparatus in accordance with claim 1, further comprising means for maintaining the pressure within said medication reservoir at a pressure level below the internal pressure of said living body.

22. An infusion apparatus in accordance with claim 21, wherein said pressure maintaining means comprises:

a flexible diaphragm which divides said medication reservoir into a medication chamber and a liquid-vapor pool chamber; and

a liquid vapor pool disposed within said liquid-vapor pool chamber, the proportion of liquid to vapor in said liquid-vapor pool varying in response to variations in the amount of said selected medication disposed in said medication chamber.

23. An infusion apparatus in accordance with claim 1, wherein said restrictor means comprises a length of tubing which has a portion of the internal diameter thereof sized to partially restrict the flow of said medication therethrough.

24. An infusion apparatus in accordance with claim 1, wherein said restrictor means comprises a filter of the type which partially restricts flow therethrough.

25. An infusion apparatus in accordance with claim 1, wherein said communication means comprises a catheter.

26. An infusion apparatus in accordance with claim 25, wherein said catheter has the tip thereof formed of pyrolytic carbon.

27. An infusion apparatus in accordance with claim 26, further comprising a check valve means disposed in said catheter, said check valve means permitting the flow of said selected medication out of said catheter but precluding the flow of body fluid of said living body from flowing therein.

28. An infusion apparatus in accordance with claim 1, further comprising a filter operably interposed between said accumulator means and said flow restrictor means to preclude the obstruction of said flow restrictor means.

29. An infusion apparatus in accordance with claim 1, further comprising a housing for containing said pump means, said accumulator means, and said restrictor means, said housing being biocompatible and for implantation within said living body.

30. An infusion apparatus for providing medication to a living body of a patient comprising:

a medication reservoir for storing selected medication;

means for pumping said selected medication, said pump means operating in a pulsatile mode, the input of said pump means being in communication with said reservoir wherein said pump means comprises,

a variable volume bellows chamber having an input and output, said input being in communication with said medication reservoir, said variable volume chamber having an effective area (A),

a moving means which is activated for increasing the volume of said bellows chamber to a preselected maximum volume thereby drawing said selected medication from said medication reservoir,

a spring means for urging said bellows chamber to contract to a preselected minimum volume, thereby forcing said selected medication through said output, said spring means providing a spring force (F), whereby said spring means is unable to force said selected medication through said output when the pressure (P) in said bellows chamber exceeds said spring force (F) divided by said effective area (A), that is when, P_max =F/A;

means for restricting the flow of said selected medication, the input of said flow restrictor means being in communication with said output of said pump means, wherein said restricting means will restrict the maximum medication flow rate into said living body, and said maximum flow rate is obtained when the pressure in said bellows chamber reaches P_max which is a result of said moving means being activated at a rapid rate, thereby preventing said pumping means from providing said selected medication at an unsafe dosage; and

means for communicating said selected medication from the output of said flow restrictor means to said living body.