Porous membranes for use with implantable devices

• US 8,118,877 B2
• Filed: 01/17/2007
• Issued: 02/21/2012
• Est. Priority Date: 05/21/2003
• Status: Active Grant

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Tapsak, Mark A., Shults, Mark C.
• Primary Examiner(s): Steele, Amber D
• Assistant Examiner(s): SINGH, SATYENDRA K
• Application Number:
  US11/654,135
• Publication Number:
  US 20100256779A1
• Time in Patent Office: 1,861 Days
• Field of Search: None
• US Class Current: 623/23.76
• 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: A61L 31/146 Porous materials, e.g. foams or sponges

Abstract

A membrane for implantation in soft tissue comprising a first domain that supports tissue ingrowth, disrupts contractile forces typically found in a foreign body response, encourages vascularity, and interferes with barrier cell layer formation, and a second domain that is resistant to cellular attachment, is impermeable to cells and cell processes, and allows the passage of analytes. The membrane allows for long-term analyte transport in vivo and is suitable for use as a biointerface for implantable analyte sensors, cell transplantation devices, drug delivery devices, and/or electrical signal delivering or measuring devices. The membrane architecture, including cavity size, depth, and interconnectivity, provide long-term robust functionality of the membrane in vivo.

Claims

1. A biointerface membrane suitable for implantation in a soft tissue, the membrane comprising layers of:

a first domain comprising an open cell configuration having a plurality of interconnected cavities and a solid portion, wherein the first domain has a depth of greater than one cavity in three dimensions substantially throughout an entirety of the first domain, and wherein the plurality of interconnected cavities and the solid portion of the first domain are dimensioned and arranged to redirect fibrous tissue contracture in vivo, thereby interfering with barrier cell layer formation within or around the first domain, and wherein a substantial number of the interconnected cavities are greater than or equal to about 90 microns in at least one dimension; and

a second domain, the second domain allowing passage of an analyte therethrough, wherein the second domain is resistant to cellular attachment and is impermeable to cells and cell processes;

wherein the first and second domain layers are adhered together to form a unitary structure.

2. The biointerface membrane according to claim 1, wherein the cavities and a plurality of cavity interconnections are formed in a plurality of layers having different cavity dimensions.

3. The biointerface membrane according to claim 1, wherein a substantial number of the cavities are less than or equal to about 1000 microns in a longest dimension.

4. The biointerface membrane according to claim 1, wherein a substantial number of shortest dimensions of the solid portion are greater than or equal to about 5 microns and wherein a substantial number of longest dimensions of the solid portion are greater than or equal to about 2000 microns.

5. The biointerface membrane according to claim 1, wherein the solid portion comprises silicone.

6. The biointerface membrane according to claim 1, wherein the solid portion comprises polyurethane.

7. The biointerface membrane according to claim 1, wherein the solid portion comprises a block copolymer.

8. The biointerface membrane according to claim 1, wherein the solid portion comprises a material selected from the group consisting of polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, and polycarbonate.

9. The biointerface membrane according to claim 1, wherein the second domain comprises a material selected from the group consisting of silicone and polyurethane.

10. The biointerface membrane according to claim 1, wherein the analyte comprises glucose.

11. A membrane suitable for implantation in a soft tissue, the membrane comprising layers of:

a first domain, the first domain comprising an open cell configuration having a plurality of interconnected cavities and a solid portion; and

a second domain, the second domain allowing passage of an analyte therethrough, wherein the second domain is resistant to cellular attachment and is impermeable to cells and cell processes,

wherein the plurality of interconnected cavities and the solid portion of the first domain are dimensioned and arranged to create a contractile force directed against the solid portion that counteracts a generally uniform downward fibrous tissue contracture caused by a foreign body response in vivo, thereby interfering with barrier cell layer formation proximal to the second domain, and wherein a substantial number of the interconnected cavities are greater than or equal to about 90 microns in at least one dimension;

wherein the first and second domain layers are adhered together to form a unitary structure.

12. The membrane according to claim 11, wherein the cavities and a plurality of cavity interconnections are formed in a plurality of layers having different cavity dimensions.

13. The membrane according to claim 11, wherein a substantial number of the cavities are less than or equal to about 1000 microns in a longest dimension.

14. The membrane according to claim 11, wherein a substantial number of shortest dimensions of the solid portion are greater than or equal to about 5 microns and wherein a substantial number of longest dimensions of the solid portion are greater than or equal to about 2000 microns.

15. The membrane according to claim 11, wherein the solid portion comprises silicone.

16. The membrane according to claim 11, wherein the solid portion comprises polyurethane.

17. The membrane according to claim 11, wherein the solid portion comprises a block copolymer.

18. The membrane according to claim 11, wherein the solid portion comprises a material selected from the group consisting of polytetrafluoroethylene, polyethylene-co-tetrafluoroethylene, polyolefin, polyester, and polycarbonate.

19. The membrane according to claim 11, wherein the second domain comprises a material selected from the group consisting of silicone and polyurethane.

20. The membrane according to claim 11, wherein the analyte comprises glucose.

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

providing an implantable device configured to monitor the analyte level, the implantable device comprising a biointerface membrane, wherein the biointerface membrane comprises;

a first domain, wherein the first domain comprises a plurality of interconnected cavities and a solid portion, wherein the plurality of interconnected cavities and the solid portion of the first domain are dimensioned and arranged to create a contractile force directed against the solid portion that counteracts a generally uniform downward fibrous tissue contracture caused by a foreign body response in vivo, thereby interfering with barrier cell layer formation within or around the first domain; and

a second domain adjacent to the first domain, the second domain allowing passage of the analyte therethrough, wherein the second domain is resistant to cellular attachment and is impermeable to cells and cell processes; and

monitoring the analyte level utilizing the implantable device.

22. The method according to claim 21, wherein the analyte comprises glucose.