Implantable artificial pancreas

• US 20040158232A1
• Filed: 08/07/2003
• Published: 08/12/2004
• Est. Priority Date: 08/07/2002
• Status: Abandoned Application

• Current Assignee: Memry Corporation
• Original Assignee: Memry Corporation
• Inventors: Schetky, Laurence MacDonald, Jardine, Peter, Moussy, Francis
• Application Number:
  US10/638,193
• Publication Number:
  US 20040158232A1
• Time in Patent Office: Days
• US Class Current: 604/890.1
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An artificial pancreas comprises a first reservoir for retaining insulin; at least one second reservoir for retaining a therapeutic agent; at least one pump in fluid communication with the first reservoir and the at least one second reservoir; and a glucose monitor in electrical communication with the pump.

Claims

1. An artificial pancreas comprising:

a first reservoir for retaining insulin;

at least one second reservoir for retaining a therapeutic agent;

at least one pump in fluid communication with the first reservoir and the at least one second reservoir; and

a glucose monitor in electrical communication with the pump.

2. The artificial pancreas of claim 1, wherein the artificial pancreas in enclosed in a biocompatible housing.

3. The artificial pancreas of claim 2, wherein the housing comprises titanium or a titanium alloy.

4. The artificial pancreas of claim 2, wherein the housing comprises a polymeric resin.

5. The artificial pancreas of claim 4, wherein the housing comprises polyamides, polytetrafluoroethylene, silicone polymers, polyolefins, nonabsorbable polyesters, homopolymers and copolymers of lactic acid, glycolic acid, lactide, glycolide, para-dioxanone, trimethylene carbonate, ∈

-caprolactone, or biocompatible combinations comprising at least one of the foregoing polymeric resins.

6. The artificial pancreas of claim 1, wherein the first reservoir and the at least one second reservoir are not in fluid communication with one another.

7. The artificial pancreas of claim 1, wherein the first reservoir has a volume of 5 to about 50 milliliters.

8. The artificial pancreas of claim 1, wherein the first and second reservoirs are refilled using a transcutaneous hypodermic injection.

9. The artificial pancreas of claim 1, wherein the pump is in fluid communication with the first reservoir and the second reservoir via a check valve.

10. The artificial pancreas of claim 1, wherein the pump can deliver fluid at pressures of greater than or equal to about 25 pounds per square inch.

11. The artificial pancreas of claim 1, wherein the pump can deliver fluid at pressures of greater than or equal to about 75 pounds per square inch.

12. The artificial pancreas of claim 1, wherein the at least one pump is a duplex pump.

13. The artificial pancreas of claim 1, wherein the at least one pump is a triplex pump.

14. The artificial pancreas of claim 1, wherein the pump comprises at least one film of shape memory alloy disposed upon a substrate, and further wherein the substrate has at least one cavity.

15. The artificial pancreas of claim 14, wherein the film is a nickel titanium alloy.

16. The artificial pancreas of claim 15, wherein the nickel titanium alloy comprises about 54.5 to about 57 wt % nickel, based on the total composition of the alloy.

17. The artificial pancreas of claim 14, wherein the film is in electrical communication with a source of electrical power.

18. The artificial pancreas of claim 17, wherein the source of electrical power is a rechargeable lithium ion battery that is charged by means of an external inductively coupled charger and further the power consumption by the film is approximately 4 milliwatts per stroke.

19. The artificial pancreas of claim 14, wherein the film operates at a maximum strain of about 1%, and wherein the fatigue life of the film is in excess of 10⁶ cycles.

20. The artificial pancreas of claim 14, wherein the substrate is a polymeric resin derived from a thermoplastic resin, a blend of thermoplastic resins, a thermosetting resin, a blend of thermosetting resins, or blends of thermoplastic with thermosetting resins.

21. The artificial pancreas of claim 14, wherein the substrate has at least one circular cavity having a radius of 1 to 20 millimeter.

22. The artificial pancreas of claim 14, wherein the substrate has two cavities.

23. The artificial pancreas of claim 14, wherein the substrate comprises silicon and has a cavity that is elliptical, circular, rectangular, square, rhombohedral, or polygonal in shape.

24. The artificial pancreas of claim 14, wherein the substrate comprises a cavity and wherein the cavity is about 2 to about 20 square millimeters in area.

25. The artificial pancreas of claim 14, wherein the volume of a dome formed by the film upon the application of an electrical current is 0.5 cubic millimeters.

26. The artificial pancreas of claim 1, wherein the pump is in fluid communication with at least two reservoirs.

27. The artificial pancreas of claim 1, comprising at least two pumps.

28. The artificial pancreas of claim 1, wherein the therapeutic agent is an anti-inflammatory agent, and wherein the anti-inflammatory agent is dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine.

29. The artificial pancreas of claim 1, wherein the glucose monitor is in electrical communication the pump via an electrical control system.

30. The artificial pancreas of claim 1, wherein the glucose monitor comprises a two electrode design comprising a platinum electrode for monitoring the glucose and a silver/silver chloride reference counter electrode.

31. The artificial pancreas of claim 1, wherein the glucose monitor comprises a sensor comprising a cation exchange polymer outer layer, a glucose oxidase layer and a poly(o-phenyenediamine) (PPD) coating disposed upon a platinum electrode.

32. The artificial pancreas of claim 31, wherein the cation exchange polymer is a sulfonated polytetrafluoroethylene.

33. The artificial pancreas of claim 1, comprising a close loop insulin deliver system.