Durable high strength polymer composites suitable for implant and articles produced therefrom
First Claim
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1. A valve, comprising:
- a support structure, andat least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane and an elastomeric material, the at least one synthetic polymer membrane comprising fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than about 1 μ
m, the space between the fibers defining pores, the elastomeric material being disposed in substantially all of the pores, wherein the elastomeric material is a tetrafluoroethylene-perfluoromethylvinyl ether (TFE/PMVE) copolymer.
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Abstract
Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, 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 a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane.
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Citations
79 Claims
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1. A valve, comprising:
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a support structure, and at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane and an elastomeric material, the at least one synthetic polymer membrane comprising fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than about 1 μ
m, the space between the fibers defining pores, the elastomeric material being disposed in substantially all of the pores, wherein the elastomeric material is a tetrafluoroethylene-perfluoromethylvinyl ether (TFE/PMVE) copolymer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A valve, comprising:
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a support structure, and at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane having a plurality of pores and an elastomeric material present in substantially all of the pores, the composite material comprising elastomeric material by weight in a range from about 10% to about 90%, wherein the elastomeric material is a tetrafluoroethylene-perfluoromethylvinyl ether (TFE/PMVE) copolymer. - View Dependent Claims (22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41)
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42. A valve, comprising:
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a support structure, and at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane and TFE/PMVE copolymer, the at least one synthetic polymer membrane comprising fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than about 1 μ
m, the space between the fibers defining pores, the TFE/PMVE copolymer being disposed in substantially all of the pores. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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60. A valve, comprising:
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a support structure, and at least one leaflet being supported on the support structure and movable between open and closed positions, each leaflet including a composite material comprising at least one synthetic polymer membrane having a plurality of pores and TFE/PMVE copolymer present in substantially all of the pores, the composite material comprising TFE/PMVE copolymer by weight in a range from about 10% to about 90%. - View Dependent Claims (61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79)
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Specification