Coherent single layer high strength synthetic polymer composites for prosthetic valves
AssigneeW. L. Gore & Associates, Inc.
InventorsWilliam C. Bruchman, Bill R. Finney, Paul D. Gassler, Cody L. Hartman, Peter J. Walsh
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Abstract
Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.
Claims32
A prosthetic valve comprising:
- a frame;
- and
- a leaflet coupled to the frame, the leaflet including at least one coherent single layer and an elastomeric material, wherein the at least one coherent single layer comprises a fluoropolymer and the elastomeric material comprises a TFE/PMVE copolymer.
A prosthetic valve comprising:
- a frame;
- and
- a leaflet coupled to the frame and movable between open and closed positions, the leaflet comprising at least one coherent single layer comprising an elastomeric material and a synthetic polymer, wherein the leaflet is impermeable, and wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.
A prosthetic valve comprising:
- a frame;
- and
- a leaflet coupled to the frame and the leaflet including at least one coherent single layer and an elastomeric material, the at least one coherent single layer having pores and is a synthetic polymer, the elastomeric material being present in the pores such that the at least one coherent single layer is impermeable, wherein the at least one coherent single layer is expanded fluoropolymer, wherein the elastomeric material is a TFE/PMVE copolymer, and wherein the prosthetic valve is operable to be a prosthetic heart valve.
A prosthetic valve comprising:
- a frame;
- and
- a leaflet coupled to the frame, the leaflet comprising at least one coherent single layer and an elastomeric material, wherein the at least one coherent single layer is a synthetic polymer, wherein the leaflet is impermeable, wherein the leaflet has a compression set of less than 10%.
Dependencies are inferred from the claim text.