Durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom
AssigneeW. L. Gore & Associates, Inc.
InventorsWilliam C. Bruchman, Paul D. Gassler, Cody L. Hartman, Peter J. Walsh
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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 layer and an elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.
Claims39
A prosthetic valve, comprising:
- a leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via a layer of the elastomer between each of the more than one fluoropolymer layer, the leaflet having a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 5.
A prosthetic valve, the prosthetic valve comprising a polymeric leaflet having a thickness of less than about 100 μm, wherein the leaflet is formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the more than one fluoropolymer layer, the more than one fluoropolymer layer being coupled together via a layer of the elastomer between each of the more than one fluoropolymer layer.
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 elastomer present in substantially all of 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 the composite material being coupled together via a layer of the elastomer between each of the more than one layer of the composite material.
A prosthetic valve, the 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 elastomer substantially filling the pores of the at least one fluoropolymer layer, the more than one layer of the composite material being coupled together via a layer of the elastomer between each of the more than one layer of the composite material, each of the more than one layer of the composite material comprising less than about 80% fluoropolymer by weight.
Dependencies are inferred from the claim text.