DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM
A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.
1 . A prosthetic valve, comprising:
a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and TFE/PMVE copolymer substantially filling the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight, the more than one layer of composite material being coupled together via the TFE/PMVE copolymer.
2 . The prosthetic valve as set forth in claim 1 , the leaflet having a ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 5.
3 . The prosthetic valve as set forth in claim 1 , wherein the leaflet has a bending modulus of less than about 100 MPa.
4 . The prosthetic valve as set forth in claim 1 , wherein the leaflet is operatively coupled to a support frame and movable between closed and open configurations relative to the support frame.
5 . The prosthetic valve as set forth in claim 4 , wherein the support frame is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site.
6 . The prosthetic valve as set forth in claim 1 , wherein the composite material comprises less than about 70% fluoropolymer by weight.
7 . The prosthetic valve as set forth in claim 1 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.
8 . The prosthetic valve as set forth in claim 1 , wherein the leaflet has a thickness of less than about 350 μm.
9 . The prosthetic valve as set forth in claim 1 , wherein the fluoropolymer layer is PTFE.
10 . The prosthetic valve as set forth in claim 9 , wherein the PTFE is ePTFE.
11 . The prosthetic valve as set forth in claim 10 , wherein the at least one fluoropolymer layer has a matrix tensile strength in at least one direction greater than about 96 MPa.
12 . A prosthetic valve, comprising:
a leaflet comprising more than one layer of a composite material having at least one fluoropolymer layer having a plurality of pores and an elastomeric material substantially filling the pores of the at least one fluoropolymer layer, the composite material comprising less than about 80% fluoropolymer by weight, the more than one layer of composite material being coupled together via the elastomeric material.
13 . The prosthetic valve as set forth in claim 12 , the leaflet having a ratio of leaflet thickness (μm) to number of fluoropolymer layers of less than about 5.
14 . The prosthetic valve as set forth in claim 12 , wherein the leaflet has a bending modulus of less than about 100 MPa.
15 . The prosthetic valve as set forth in claim 12 , wherein the leaflet is operatively coupled to a support frame and movable between closed and open configurations relative to the support frame.
16 . The prosthetic valve as set forth in claim 12 , wherein the composite material comprises less than about 70% fluoropolymer by weight.
17 . The prosthetic valve as set forth in claim 12 , wherein the leaflet has a thickness of less than about 350 μm.
18 . The prosthetic valve as set forth in claim 12 , wherein the leaflet has a thickness of less than about 300 μm.
19 . The prosthetic valve as set forth in claim 12 , wherein the fluoropolymer layer is PTFE.
20 . The prosthetic valve as set forth in claim 19 , wherein the PTFE is ePTFE.
21 . The prosthetic valve as set forth in claim 20 , wherein the at least one fluoropolymer layer has a matrix tensile strength in at least one direction greater than about 96 MPa.
22 . The prosthetic valve as set forth in claim 12 , wherein the elastomeric material is TFE/PMVE copolymer.