Durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom

Abstract

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.

What is claimed is: 
     
         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.