Programmable valve pump

• US 5,049,141 A
• Filed: 04/25/1990
• Issued: 09/17/1991
• Est. Priority Date: 04/25/1990
• Status: Expired due to Term

• Current Assignee: Flowonix Medical, Inc.
• Original Assignee: InfusAID, Inc. (Pfizer Inc.)
• Inventors: Olive, Peter
• Primary Examiner(s): Stone, Cary E.
• Assistant Examiner(s): Lynch, Michael
• Application Number:
  US07/514,442
• Time in Patent Office: 510 Days
• Field of Search: 604/118, 604/131, 604/141, 604/142, 604/246, 604/891.1, 417/412, 417/413, 128/DIG. 12, 128/DIG. 13
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2206/22 eliminating pulsatile flows, e.g. by the provision of a dampening chamber
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/16809 by repeated filling and emptying of an intermediate volume pressure infusion using positive displacement pumps A61M5/142
• CPC Class Codes: F04B 43/04 Pumps having electric drive
• CPC Class Codes: G01F 11/08 of the diaphragm or bellows type
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

An implantable valve accumulator pump for the delivery of medication is disclosed. The implantable pump comprises a drug reservoir maintained at constant pressure vapor. The medication metering assembly comprises a fixed volume accumulator positioned between a pair of valves. The valves alternately open and close to admit medication from the reservoir into the accumulator and to dispense a precise volume spike to an outlet catheter. In order to minimize dead volume and insure complete discharge, the accumulator employs a titanium diaphragm seated in one position by a recessed stop and in the discharge position by a spacer plate having a concentric groove pattern. The grooves are in fluid communication with the inlet and outlet. Also, a wide groove extending between inlet and outlet provides fluid communication between the grooves. The unit is externally programmed.

Claims

1. An implantable infusion apparatus comprising:

a housing containing,

a rechargeable constant pressure infusate reservoir,

an electronically controlled metering assembly receiving infusate from said reservoir, said metering assembly comprising a pair of normally closed valves and an accumulator positioned in fluid communication with each of said valves, said accumulator comprising an inlet and outlet, a chamber having a diaphragm and a spacer plate, said spacer plate having a series of concentric grooves in fluid communication with said inlet and outlet,

electronic means for controlling the operation of said valves, and

outlet means in fluid communication with said metering assembly to dispense infusate to a site in a living body, wherein when a first of said valves is open, infusate flows from said reservoir into said accumulator chamber and into said concentric grooves, and when the other valve is open and the first closes, infusate flows from said accumulator into said outlet, said accumulator storing and discharging predetermined volume spikes of infusate at a frequency determined by the cycling rate of said pair of valves.

2. The device of claim 1, further comprising a bacteria/air filter arranged in said housing in a wall that separates said reservoir from the metering assembly.

3. The device of claim 1, wherein said housing further comprises a disk-shaped upper member, a hollow lower member and an internal base plate dividing the interior of the housing into two chambers, a solid central core disposed on said base plate and said disk-shaped upper member said central core comprising a septum for refilling said reservoir.

4. The device of claim 3, further comprising a needle-stop and an inlet check valve disposed in the central core.

5. The device of claim 1, wherein said pair of valves are positioned side-by-side in fluid isolation, each of said valves having a conduit to said accumulator that may be opened or closed by a valve member and, said accumulator positioned on both of said valves, said accumulator having said inlet aligned with one of said conduits and said outlet aligned with the other of said conduits.

6. The device of claim 1, wherein said accumulator further comprises an end cap, a backing plate, and said spacer plate has a straight groove connecting said inlet and said outlet, said diaphragm positioned between said backing plate and said spacer plate.

7. The device of claim 6 wherein said backing plate contains a recess, said recess covered by said end cap, means to fill said recess with a fluid under pressure and means in said backing plate to establish fluid communication between said recess and one side of said diaphragm.

8. The device of claim 6, wherein contoured surface defines a stop for said diaphragm when said accumulator has been filled with infusate, said contoured surface contacting substantially the entire surface of said diaphragm to limit any change in the stored volume of the accumulator irrespective of changes in pressure of infusate delivered from the reservoir.

9. The device of claim 6, wherein said spacer plate concentric grooves are separated by sharp projecting edges, said projecting edges contacting and supporting said diaphragm when said accumulator is emptied.

10. The device of claim 9, wherein said spacer plate straight groove is in fluid communication with said concentric grooves.

11. The device of claim 6 said backing plate further comprising a conductive inner surface, an insulator isolating said backing plate and, electrical means providing an output to determine the position of said diaphragm.

12. The device of claim 6, said spacer plate further comprising an outer flat annular surface for sealing said spacer plate within said accumulator.

13. The device of claim 1, further comprising programmer means external to said housing for interrogating and programming said electronic means.

14. The device of claim 1, wherein said outlet means comprises a catheter attached to said housing, said outlet catheter including a connector insertable into said outlet port.

15. The device of claim 1, further comprising a sideport for the direct injection of a drug into said outlet.

16. An implantable infusion apparatus comprising:

a sealed housing having an inlet septum,

a rechargeable constant pressure infusate reservoir in said housing,

metering means in said housing receiving infusate from said reservoir, said metering means comprising first and second valves and a fixed volume accumulator positioned in fluid communication with each of said valves, said accumulator comprising an inlet and an outlet, a chamber, a diaphragm and spacer plate in said chamber, said spacer plate having a series of concentric grooves in fluid communication with said inlet and outlet,

electronic means in said housing for controlling the operation of said valves, such that when a first of said valves is open, infusate flows from said reservoir into said accumulator to fill said accumulator by deflection of said diaphragm and when the second valve is open and the first valve closes, infusate flows from said accumulator and, outlet means in fluid communication with said metering means to dispense infusate to a site in a living body, whereby infusate dispensed in a series of predetermined volume spikes, the frequency of said spikes determined by the cycling rate of said first and second valves.

17. The device of claim 16, further comprising filter means arranged in said sealed housing in a wall that separates said reservoir from said metering means.

18. The device of claim 16, wherein said sealed housing comprises a disk-shaped upper member, a hollow lower member and an internal baseplate dividing the interior of the housing into two chambers, a solid central core disposed on said baseplate and said disk-shaped upper member, said central core positioning said septum for refilling said reservoir, and further comprising a needle-stop disposed below said septum and an inlet check valve disposed below said needle-stop.

19. The device of claim 16, wherein said first and second valves are positioned side-by-side in fluid isolation with each other, each of said valves having a conduit to said accumulator that may be opened or closed by a valve member and, said accumulator having said inlet aligned with one of said conduits and said outlet aligned with the other of said conduits.

20. The device of claim 16, wherein said accumulator comprises an end cap, a backing plate, an inextensible diaphragm, and said spacer plate having a straight groove in fluid communication between said inlet and said outlet said diaphragm sandwiched between said backing plate and said spacer plate.

21. The device of claim 20, wherein said backing plate contains a recess, said recess covered by said end cap, means to fill said recess with a fluid under pressure and conduit means in said backing plate to establish fluid communication between said recess and one side of said diaphragm to bias said diaphragm.

22. The device of claim 20, wherein said contoured surface defines a stop for said diaphragm when said accumulator has been filled with infusate whereby said contoured surface contacting substantially the entire surface of said diaphragm to limit any change in the stored volume of the accumulator irrespective of changes in pressure of infusate delivered from the reservoir to said accumulator.

23. The device of claim 22, wherein said spacer plate concentric grooves are separated by a series of sharp projecting walls supporting said diaphragm.

24. The device of claim 23, wherein said spacer plate concentric grooves are in fluid communication with said straight groove.

25. The device of claim 20 wherein said backing plate comprises a conductive inner surface, an insulator isolating said backing plate from said spacer plate and, electrical means providing an output to determine the position of said diaphragm.

26. The device of claim 16, further comprising programmer means external to said housing for interrogating and programming said electronic means.

27. The device of claim 16, wherein said outlet means comprises an outlet catheter attached to said housing, said outlet catheter including a connector lockably insertable into said outlet port.

28. The device of claim 16, further comprising a sideport for the direct injection of a drug into said outlet.