Biointerface membrane with macro-and micro-architecture
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.
1. A biointerface membrane comprising a biostable membrane configured and arranged to be disposed on an in vivo implantable device, the biostable membrane comprising:
a macro-architecture defining a plurality of interconnected cavities that are greater than or equal to about 20 microns in a longest dimension; and
a micro-architecture located within at least some of the cavities of the macro-architecture, wherein the micro-architecture has a plurality of interconnected cavities that are less than or equal to about 20 microns in at least one dimension, and wherein the interconnected cavities of the micro-architecture are sized such that a plurality of the interconnected cavities of the micro-architecture fit within one interconnected cavity of the macro-architecture.
2. The biointerface membrane of claim 1 , wherein the membrane, when disposed on an implantable device, is adapted to support tissue ingrowth and to interfere with barrier cell layer formation.
3. The biointerface membrane of claim 1 , wherein the macro-architecture is formed from a homopolymer, copolymer, or 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 biointerface membrane of claim 1 , wherein the micro-architecture comprises a homopolymer, copolymer, or 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 biointerface membrane of claim 1 , wherein the macro-architecture comprises a silicone material having a structure that defines the cavities.
6. The biointerface membrane of claim 1 , wherein the micro-architecture comprises a silicone material.
7. The biointerface membrane of claim 1 , wherein the micro-architecture comprises a non-woven fibrous material.
8. The biointerface membrane of claim 7 , wherein the micro-architecture comprises expanded-polytetrafluoroethylene.
9. The biointerface membrane of claim 1 , wherein the micro-architecture is located throughout substantially all of the cavities of the macro-architecture.
10. The biointerface membrane of claim 1 , wherein the micro-architecture comprises elongated strands of material that are less than or equal to about 20 microns in a shortest dimension.
11. The biointerface membrane of claim 1 , wherein the plurality of interconnected cavities of the microarchitecture are at least about 0.6 microns in the at least one dimension.