Durable high strength composite prosthetic valve leaflets

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 heart pacing lead or heart valve leaflet. The composite material includes at least one porous expanded fluoropolymer membrane.

What is claimed is: 
     
         1 . A prosthetic valve, comprising:
 a support structure, and   at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including at least one composite layer comprising one fluoropolymer membrane having a plurality of pores and an elastomer or elastomeric material present in substantially all of the pores of the fluoropolymer membrane, wherein the fluoropolymer membrane comprises fibrils, wherein a diameter of a majority of the fibrils is less than 1 μm.   
     
     
         2 . The prosthetic valve of  claim 1 , wherein the elastomer or elastomeric material is a fluoroelastomer. 
     
     
         3 . The prosthetic valve of  claim 1 , wherein the elastomer or elastomeric material is a tetrafluoroethylene/perfluoromethyl vinyl ether (TFE/PMVE) copolymer. 
     
     
         4 . The prosthetic valve of  claim 3 , 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. 
     
     
         5 . The prosthetic valve of  claim 1 , wherein the fluoropolymer membrane is a polytetrafluoroethylene (PTFE) membrane. 
     
     
         6 . The prosthetic valve of  claim 5 , wherein the PTFE membrane is an expanded PTFE (ePTFE) membrane. 
     
     
         7 . The prosthetic valve of  claim 3 , wherein the fluoropolymer membrane is polytetrafluoroethylene (PTFE) membrane. 
     
     
         8 . The prosthetic valve of  claim 7 , wherein the PTFE membrane is an expanded PTFE (ePTFE) membrane. 
     
     
         9 . The prosthetic valve of  claim 8 , wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.5. 
     
     
         10 . The prosthetic valve of  claim 8 , wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.3. 
     
     
         11 . The prosthetic valve of  claim 1 , wherein the leaflet has a bending modulus of less than 100 MPa. 
     
     
         12 . The prosthetic valve of  claim 1 , wherein the pores have a pore size that is less than 5 μm. 
     
     
         13 . The prosthetic valve of  claim 1 , wherein the pores have a pore size that is less than 1 μm. 
     
     
         14 . The prosthetic valve of  claim 1 , wherein the pores have a pore size that is less than 0.10 μm. 
     
     
         15 . The prosthetic valve of  claim 1 , wherein the leaflet has a thickness of less than 100 μm. 
     
     
         16 . The prosthetic valve of  claim 1 , wherein the leaflet has only one composite layer. 
     
     
         17 . The prosthetic valve of  claim 1 , wherein the leaflet includes at least 10 composite layers. 
     
     
         18 . The prosthetic valve of  claim 1 , wherein a ratio of leaflet thickness (μm) to number of composite layers is less than about 5. 
     
     
         19 . The prosthetic valve of  claim 1 , wherein a ratio of leaflet thickness (μm) to number of composite layers is less than about 3. 
     
     
         20 . The prosthetic valve of  claim 1 , wherein a ratio of leaflet thickness (μm) to number of composite layers is less than about 1. 
     
     
         21 . The prosthetic valve of  claim 1 , wherein a ratio of leaflet thickness (μm) to number of composite layers is less than about 0.5. 
     
     
         22 . The prosthetic valve of  claim 1 , wherein the leaflet has at least 10 composite layers with each composite layer comprising less than 50% fluoropolymer by weight. 
     
     
         23 . The prosthetic valve of  claim 1 , wherein the support structure is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site. 
     
     
         24 . A method of treating a failing or dysfunctional native valve with a prosthetic valve, the method comprises:
 replacing the native valve with the prosthetic valve, the prosthetic valve comprising:   a support structure, and   at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including at least one composite layer comprising one fluoropolymer membrane having a plurality of pores and an elastomer or elastomeric material present in substantially all of the pores of the fluoropolymer membrane, wherein the fluoropolymer membrane comprises fibrils, wherein a diameter of a majority of the fibrils is less than 1 μm.   
     
     
         25 . The method of  claim 24 , wherein the fluoropolymer membrane is expanded polytetrafluoroethylene (ePTFE) membrane, and wherein the elastomer or elastomeric material is a tetrafluoroethylene/perfluoromethyl vinyl ether (TFE/PMVE) copolymer.