Methods of making a durable multi-layer high strength polymer composite suitable for prosthetic valves
First Claim
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1. A method of making a leaflet of a prosthetic valve, the method comprising:
- providing a composite material having a fluoropolymer layer having a plurality of pores and an elastomer or elastomeric material resent in the pores of the fluoropolymer layer, the composite material having a predetermined matrix tensile strength that is greater in a first direction relative to a second direction that is orthogonal to the first direction;
arranging the composite material to define at least two overlapping adjacent layers of the composite material, the at least two overlapping adjacent layers of the composite material being oriented such that the first direction of each layer is generally parallel to each other;
bonding the respective adjacent layers of the composite material together via the elastomer or elastomeric material forming a leaflet construct; and
cutting the leaflet construct to form a leaflet having a leaflet width and a leaflet length that is orthogonal to the leaflet width, the leaflet length extending in a flow direction, wherein the first direction of the composite material is parallel with the leaflet width.
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Abstract
Methods are presented that provide a thin, biocompatible, high-strength, composite material that is suitable for use in prosthetic valves. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to prosthetic valve leaflets. The composite material includes more than one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.
80 Citations
32 Claims
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1. A method of making a leaflet of a prosthetic valve, the method comprising:
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providing a composite material having a fluoropolymer layer having a plurality of pores and an elastomer or elastomeric material resent in the pores of the fluoropolymer layer, the composite material having a predetermined matrix tensile strength that is greater in a first direction relative to a second direction that is orthogonal to the first direction; arranging the composite material to define at least two overlapping adjacent layers of the composite material, the at least two overlapping adjacent layers of the composite material being oriented such that the first direction of each layer is generally parallel to each other; bonding the respective adjacent layers of the composite material together via the elastomer or elastomeric material forming a leaflet construct; and cutting the leaflet construct to form a leaflet having a leaflet width and a leaflet length that is orthogonal to the leaflet width, the leaflet length extending in a flow direction, wherein the first direction of the composite material is parallel with the leaflet width. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A method of making a leaflet of a prosthetic valve, the method comprising:
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providing a composite material having a fluoropolymer layer having a plurality of pores and tetrafluoroethylene perfluoromethyl vinyl ether (TFE/PMVE) copolymer present in the pores of the fluoropolymer layer, the composite material having a predetermined matrix tensile strength that is greater in a first direction relative to a second direction that is orthogonal to the first direction; arranging the composite material to define at least two overlapping adjacent layers of the composite material, the at least two overlapping adjacent layers of the composite material being oriented such that the first direction of each layer is generally parallel to each other; bonding the respective adjacent layers of composite material together via the TFE/PMVE copolymer forming a leaflet construct; and cutting the leaflet construct to form a leaflet having a leaflet width and a leaflet length that is orthogonal to the leaflet width, the leaflet length extending in a flow direction, wherein the first direction of the composite material is parallel with the leaflet width. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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Specification