Coherent single layer high strength synthetic polymer composites for prosthetic valves
First Claim
Patent Images
1. A prosthetic valve comprising:
- a frame; and
a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is a single ply of porous synthetic polymer membrane, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.
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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.
91 Citations
381 Claims
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1. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is a single ply of porous synthetic polymer membrane, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa. - View Dependent Claims (46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59)
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2. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is a single ply of porous synthetic polymer membrane, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a break force of greater than about 1 N/mm. - View Dependent Claims (60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73)
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3. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa. - View Dependent Claims (74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87)
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4. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a break force of greater than about 1 N/mm. - View Dependent Claims (88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101)
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5. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet passes a compressive bending test. - View Dependent Claims (102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115)
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6. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a compression set of less than 15%. - View Dependent Claims (116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129)
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7. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet has a liquid pickup of less than 10%. - View Dependent Claims (130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143)
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8. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ
m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ
m, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2. - View Dependent Claims (144, 145, 146, 147, 148, 149, 150, 151, 152, 153, 154, 155, 156, 157)
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9. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, wherein each ply comprises the same material, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies raised above a crystalline melt temperature of the polymer. - View Dependent Claims (158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171)
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10. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, wherein each ply comprises the same material, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies then expanded, and the plies raised above a crystalline melt temperature of the polymer. - View Dependent Claims (172, 173, 174, 175, 176, 177, 178, 179, 180, 181, 182, 183, 184, 185)
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11. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material, wherein each ply is expanded polymer membrane prior to the plies being bonded together, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies then raised above a crystalline melt temperature of the polymer. - View Dependent Claims (186, 187, 188, 189, 190, 191, 192, 193, 194, 195, 196, 197, 198, 199)
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12. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein an average diameter of the fibers is less than about 1 μ
m, the space between the fibers defining the pores. - View Dependent Claims (13, 200, 201, 202, 203, 204, 205, 206, 207, 208, 209, 210, 211, 212, 213)
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14. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer comprises fibers that define space therebetween, the space between the fibers defining pores that have a pore size that is less than about 5 μ
m. - View Dependent Claims (214, 215, 216, 217, 218, 219, 220, 221, 222, 223, 224, 225, 226, 227)
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15. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is a fluoropolymer, wherein the fluoropolymer is PTFE, wherein the PTFE is ePTFE, wherein the elastomer is a TFE/PMVE copolymer. - View Dependent Claims (16, 228, 229, 230, 231)
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17. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa. - View Dependent Claims (232, 233, 234, 235, 236, 237, 238, 239, 240, 241, 242, 243, 244, 245)
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18. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a break force of greater than about 1 N/mm. - View Dependent Claims (19, 20, 246, 247, 248, 249, 250, 251, 252, 253, 254, 255, 256, 257, 258, 259)
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21. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a thickness of less than about 350 μ
m. - View Dependent Claims (260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273)
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22. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet comprises elastomer by weight in a range from about 35% to about 90%. - View Dependent Claims (274, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 285, 286, 287)
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23. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is expanded fluoropolymer, wherein the elastomer is a TFE/PMVE copolymer, and wherein the valve is operable to be a prosthetic heart valve. - View Dependent Claims (288, 289, 290, 291, 292)
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24. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the at least one coherent single layer is expanded PTFE, wherein the elastomer is a TFE/PMVE copolymer, and wherein the valve is operable to be a prosthetic heart valve. - View Dependent Claims (293, 294, 295, 296)
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25. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a compression set of less than 15%. - View Dependent Claims (26, 27, 297, 298, 299, 300, 301, 302, 303, 304, 305, 306, 307, 308, 309, 310)
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28. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a light transmission of more than 60% at a 550 μ
m wavelength. - View Dependent Claims (29, 30, 311, 312, 313, 314, 315, 316, 317, 318, 319, 320, 321, 322, 323, 324)
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31. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet has a liquid pickup of less than 10%. - View Dependent Claims (32, 33, 325, 326, 327, 328, 329, 330, 331, 332, 333, 334, 335, 336, 337, 338)
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34. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, each coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that each coherent single layer is impermeable, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2. - View Dependent Claims (35, 36, 339, 340, 341, 342, 343, 344, 345, 346, 347, 348, 349, 350, 351, 352)
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37. A prosthetic valve comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, the coherent single layer has pores and comprises a synthetic polymer, the elastomer present in the pores such that the leaflet has a light transmission of at least 60% at a 550 μ
m wavelength. - View Dependent Claims (353, 354, 355, 356, 357, 358, 359, 360, 361, 362, 363, 364, 365, 366)
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38. A prosthetic valve, comprising:
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a frame; and a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and TFE/PMVE copolymer, the coherent single layer having pores and is a synthetic polymer, the TFE/PMVE copolymer being present in the pores such that the coherent single layer is impermeable. - View Dependent Claims (39, 40, 41, 367, 368, 369, 370, 371, 372, 373, 374)
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42. A heart implant device, comprising:
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at least one coherent single layer; and TFE/PMVE copolymer, the coherent single layer having pores and is a synthetic polymer, the TFE/PMVE copolymer being present in the pores such that the coherent single layer is impermeable. - View Dependent Claims (43, 44, 45, 375, 376, 377, 378, 379, 380, 381)
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Specification