METHODS OF MAKING A PROSTHETIC VALVE WITH A DURABLE HIGH STRENGTH POLYMER COMPOSITE LEAFLET

摘要

Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

主权项

1. A method of making a prosthetic valve, comprising:
providing a support structure defining a plurality of posts; and coupling a leaflet to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer present in the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the elastomer between each of the at least three layers of composite material, a method of making the composite material comprising: dissolving an elastomer in a solvent suitable to create a solution to fill the pores of the fluoropolymer layer; filling the pores of the fluoropolymer layer; and allowing the solvent to evaporate so that the elastomer remains in the pores of the fluoropolymer layer.