BIOINTERFACE WITH MACRO- AND MICRO-ARCHITECTURE

• US 20080195232A1
• Filed: 04/15/2008
• Published: 08/14/2008
• Est. Priority Date: 02/12/2004
• Status: Abandoned Application

• Current Assignee: DexCom Incorporated
• Original Assignee: DexCom Incorporated
• Inventors: Brauker, James H., Carr-Brendel, Victoria, Simpson, Peter C.
• Application Number:
  US12/103,594
• Publication Number:
  US 20080195232A1
• Time in Patent Office: Days
• US Class Current: 623/23.76
• CPC Class Codes: A61L 2300/10 containing or releasing inorganic materials
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

Abstract

Disclosed herein are biointerface membranes including a macro-architecture and a micro-architecture co-continuous with and bonded to and/or located within at least a portion of the macro-architecture. The macro- and micro-architectures work together to manage and manipulate the high-level tissue organization and the low-level cellular organization of the foreign body response in vivo, thereby increasing neovascularization close to a device-tissue interface, interfering with barrier cell layer formation, and providing good tissue anchoring, while reducing the effects of motion artifact, and disrupting the organization and/or contracture of the FBC. The biointerface membranes of the preferred embodiments can be utilized with implantable devices such as devices for the detection of analyte concentrations in a biological sample (for example, from a body), cell transplantation devices, drug delivery devices, electrical signal delivering or measuring devices, and/or combinations thereof.

Claims

1. An implantable device, comprising:

an implantable body; and

a biointerface membrane covering at least a portion of the body, wherein the biointerface comprises;

a macro-architecture defining a plurality of interconnected cavities that are greater than or equal to about 20 microns in at least one dimension; and

a micro-architecture located within at least some of the cavities of the macro-architecture, wherein the micro-architecture has a nominal cavity size of less than or equal to about 20 microns.

2. The device of claim 1, wherein the biointerface membrane is adapted to support tissue ingrowth and to interfere with barrier cell layer formation.

3. The device of claim 1, wherein the macro-architecture is formed from at least one of a homopolymer, a copolymer, and a terpolymer comprising a material selected from the group consisting of polyurethane, silicone, polyethylene-co-tetrafluoroethylene, polypropylene, polyvinylchloride, polyvinylidene fluoride, polybutylene terephthalate, polymethylmethacrylate, polyether ether ketone, cellulose ester, polysulfone, polyolefin, polyester, polycarbonate, polytetrafluoroethylene, and combinations thereof.

4. The device of claim 1, wherein the micro-architecture comprises at least one of a homopolymer, a copolymer, and a terpolymer comprising a material selected from the group consisting of polyethylene-co-tetrafluoroethylene, polyurethane, silicone, polyethylene, polypropylene, polyvinylchloride, polyvinylidene fluoride, polyvinylidene difluoride, polybutylene terephthalate, polymethylmethacrylate, polyether ether ketone, cellulose ester, polysulfone, polyolefin, nylon, polyacrylonitrile, polyester, polycarbonate, polytetrafluoroethylene, expanded-polytetrafluoroethylene, and combinations thereof.

5. The device of claim 1, wherein the macro-architecture comprises a silicone material having a structure that defines the cavities.

6. The device of claim 1, wherein the micro-architecture comprises a silicone material.

7. The device of claim 1, wherein the micro-architecture comprises a non-woven fibrous material.

8. The device of claim 7, wherein the micro-architecture comprises expanded-polytetrafluoroethylene.

9. The device of claim 1, wherein the micro-architecture is located within a portion of the macro-architecture proximal to the implantable device.

10. The device of claim 1, wherein the micro-architecture is located throughout substantially all of the cavities of the macro-architecture.

11. The device of claim 1, wherein the device comprises a glucose sensor, and wherein the biointerface membrane is located over a sensing portion of the body.

12. The device of claim 1, wherein the device comprises a drug-delivery device, wherein the drug delivery device is configured and arranged to deliver one or more drugs, and wherein the biointerface membrane is located over a drug-delivering portion of the body.

13. The device of claim 1, wherein the device comprises a cell-transplantation device, wherein the cell-transplantation device is configured to receive one or more cells for transplantation.

14. An implantable device, comprising:

an implantable body and a biointerface membrane located over at least a portion of the implantable body, wherein the biointerface membrane comprises a macro-architecture and a micro-architecture, wherein the macro-architecture and the micro-architecture are co-continuous and interconnected, wherein the macro-architecture and the micro-architecture are configured and arranged to promote vascularization within the biointerface membrane and to interfere with barrier cell layer formation, and wherein the biointerface membrane is configured to facilitate long-term analyte transport in vivo.

15. The device of claim 14, wherein the first architecture comprises a plurality of interconnected cavities that are greater than or equal to about 20 microns in at least one dimension, and wherein the second architecture is located within at least some of the cavities of the macro-architecture and has a nominal cavity size of less than or equal to about 20 microns.

16. An implantable device, comprising:

an implantable body and a biointerface membrane located over at least a portion of the implantable body, wherein the biointerface comprising comprises;

a first architecture comprising cavities configured and arranged to facilitate ingrowth of invasive cells and vascular tissue into the biointerface membrane; and

a second architecture comprising cavities configured and arranged to facilitate ingrowth of invasive cells into the biointerface membrane while not facilitating ingrowth of vascular tissue.

17. The device of claim 16, wherein the first architecture comprises a plurality of interconnected cavities that are greater than or equal to about 20 microns in at least one dimension, and wherein the second architecture is located within at least some of the cavities of the macro-architecture and has a nominal cavity size of less than or equal to about 20 microns.