Membrane for use with implantable devices

• US 7,632,228 B2
• Filed: 01/29/2004
• Issued: 12/15/2009
• Est. Priority Date: 07/27/2001
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Shults, Mark C., Brauker, James H., Tapsak, Mark A.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US10/768,889
• Publication Number:
  US 20040186362A1
• Time in Patent Office: 2,147 Days
• Field of Search: 600/309, 600/345, 600/347, 204/403.01, 204/403.06, 204/403.07, 204/403.1, 204/403.11, 204/403.14, 204/415
• US Class Current: 600/309
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/14735 comprising an immobilised reagent
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: Y10T 428/249921 Web or sheet containing structurally defined element or component

Abstract

The present invention provides a biointerface membrane for use with an implantable device that interferes with the formation of a barrier cell layer including; a first domain distal to the implantable device wherein the first domain supports tissue attachment and interferes with barrier cell layer formation and a second domain proximal to the implantable device wherein the second domain is resistant to cellular attachment and is impermeable to cells. In addition, the present invention provides sensors including the biointerface membrane, implantable devices including these sensors or biointerface membranes, and methods of monitoring glucose levels in a host utilizing the analyte detection implantable device of the invention. Other implantable devices which include the biointerface membrane of the present invention, such as devices for cell transplantation, drug delivery devices, and electrical signal delivery or measuring devices are also provided.

Claims

1. A biointerface membrane, the membrane comprising:

a first domain, wherein the first domain comprises a solid portion having a plurality of interconnected cavities therein that form an architecture that supports tissue in ingrowth and interferes with barrier cell layer formation, wherein the solid portion comprises silicone; and

a second domain, wherein the second domain is permeable to the passage of an analyte and is impermeable to cells or cell processes.

2. The biointerface membrane according to claim 1, wherein the cavities form a cavernous configuration with greater than one cavity in three dimensions substantially throughout the entirety of the first domain.

3. The biointerface membrane according to claim 2, wherein the cavities are formed in a plurality of layers, each layer having different cavity dimensions.

4. The biointerface membrane according to claim 1, wherein a substantial number of the cavities are from about 20 microns to about 2000 microns in at least one dimension.

5. The biointerface membrane according to claim 1, wherein a substantial number of the cavities are from about 25 microns to about 1000 microns in at least one dimension.

6. The biointerface membrane according to claim 1, wherein the second domain comprises a biostable material.

7. The biointerface membrane according to claim 6, wherein the biostable material comprises a hydrophobic portion and a hydrophilic portion.

8. The biointerface membrane according to claim 6, wherein the biostable material comprises polyurethane.

9. The biointerface membrane according to claim 6, wherein the biostable material comprises polyurethane and a hydrophilic polymer.

10. The biointerface membrane according to claim 6, wherein the biostable material comprises polyurethane and polyvinylpyrrolidone.

11. The biointerface membrane according to claim 6, wherein the bio stable material comprises silicone and a hydrophilic component.

12. The biointerface membrane according to claim 6, wherein the biostable material comprises silicone and polyethylene glycol.

13. An implantable device, the device comprising a biointerface membrane, the membrane comprising a first domain and a second domain, wherein the first domain is distal to the implantable device, wherein the first domain comprises a solid portion comprising silicone and having a plurality of interconnected cavities therein that form a cavernous configuration with greater than one cavity in three dimensions substantially throughout the entirety of the first domain, wherein the second domain is proximal to the implantable device, and wherein the second domain is permeable to the passage of a chemical and is impermeable to cells or cell processes.

14. The implantable device of claim 13, comprising an analyte sensor.

15. The implantable device of claim 13, comprising a glucose sensor.

16. The implantable device of claim 13, comprising a cell transplantation device.

17. The implantable device of claim 13, comprising a drug delivery device.

18. The implantable device of claim 17, wherein the drug delivery device is selected from the group consisting of a pump, a microcapsule, and a macrocapsule.

19. The implantable device of claim 13, comprising an electrical signal measuring device.

20. The implantable device of claim 13, comprising an electrical pulse delivering device.

21. A method of monitoring an analyte level, the method comprising:

implanting an implantable analyte sensor in a host, the sensor comprising a biointerface membrane, the membrane comprising a first domain and a second domain, wherein the first domain is distal to the implantable device, wherein the first domain comprises a solid portion comprising silicone and having a plurality of interconnected cavities therein that form an architecture that supports tissue ingrowth and interferes with barrier cell layer formation, wherein the second domain is proximal to the implantable device, and wherein the second domain is permeable to the passage of an analyte and is impermeable to cells or cell processes; and

monitoring an analyte level.

22. The method according to claim 21, wherein implanting the sensor in the host comprises implanting the sensor in a subcutaneous tissue of a host.

23. The method according to claim 21, wherein the analyte sensor is configured to permit accurate continuous analyte sensing.

24. The method according to claim 21, wherein implanting the sensor in the host comprises implanting the sensor in a subcutaneous tissue of a host.

25. An implantable device, the device comprising:

a membrane, the membrane comprising a biointerface region comprising a cavernous first portion and a non-cavernous second portion, wherein the non-cavernous second portion is resistant to cellular attachment, cells, or cell processes, and wherein the non-cavernous second portion is permeable to the passage of at least one chemical, wherein the cavernous first portion comprises a plurality of interconnected cavities and has greater than one cavity in three dimensions substantially throughout the entirety of the cavernous first portion.

26. The implantable device according to claim 25, wherein the cavernous first portion comprises a solid portion formed with the plurality of interconnected cavities therein and configured to support tissue ingrowth and interfere with barrier cell layer formation.

27. The implantable device according to claim 25, wherein a substantial number of the cavities are from about 20 microns to about 2000 microns in at least one dimension.

28. The implantable device according to claim 25, wherein a substantial number of the cavities are from about 25 microns to about 1000 microns in at least one dimension.

29. The implantable device according to claim 25, wherein the cavities are formed in a plurality of layers, each layer having different cavity dimensions.

30. The implantable device according to claim 25, wherein the second portion comprises a biostable material.

31. The implantable device according to claim 30, wherein the biostable material comprises a hydrophobic portion and a hydrophilic portion.

32. The implantable device according to claim 30, wherein the biostable material comprises polyurethane.

33. The implantable device according to claim 30, wherein the biostable material comprises polyurethane and a hydrophilic polymer.

34. The implantable device according to claim 30, wherein the biostable material comprises polyurethane and polyvinylpyrrolidone.

35. The implantable device according to claim 30, wherein the biostable material comprises silicone and a hydrophilic component.

36. The implantable device according to claim 30, wherein the first portion comprises silicone.

37. The implantable device according to claim 25, wherein the device comprises an implantable glucose sensor.

38. The implantable device according to claim 25, wherein the device comprises a cell transplantation device.

39. The implantable device according to claim 25, wherein the device comprises a drug delivery device.

40. The implantable device according to claim 39, wherein the drug delivery device is selected from the group consisting of a pump, a microcapsule, and a macrocapsule.

41. The implantable device according to claim 25, wherein the device comprises an electrical signal measuring device.

42. The implantable device according to claim 25, wherein the device comprises an electrical pulse delivering device.

43. An implantable glucose sensor, the sensor comprising:

a porous silicone portion;

a non-porous skin, wherein the non-porous skin is adjacent to the porous silicone portion, and wherein the non-porous skin is permeable to glucose and is impermeable to cells or cell processes; and

a glucose measuring device.

44. An implantable sensor, the sensor comprising:

a porous membrane comprising silicone and configured to allow cells and cell processes to pass through;

a non-porous membrane that is permeable to analytes and impermeable to cells and cell processes; and

an analyte measuring device.

45. An implantable glucose sensor, the sensor comprising:

a fibrous domain that supports tissue ingrowth and configured to allow cells and cell processes to pass through;

a non-fibrous domain, wherein the non-fibrous domain is adjacent to the fibrous domain, and wherein the non-fibrous domain is permeable to analytes and is impermeable to cells or cell processes; and

a glucose measuring device.