DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM
First Claim
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1. An implantable article for regulating blood flow direction in a human patient, 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 leaflet having a ratio of leaflet thickness (μ
m) to number of layers of fluoropolymer of less than about 5.
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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.
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Citations
69 Claims
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1. An implantable article for regulating blood flow direction in a human patient, 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 leaflet having a ratio of leaflet thickness (μ
m) to number of layers of fluoropolymer of less than about 5.- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. An implantable article for regulating blood flow direction in a human patient, the article comprising:
a leaflet cyclable between a closed configuration for substantially preventing blood flow through the implantable article and an open configuration allowing blood flow through the implantable article, the leaflet being formed from a plurality of fluoropolymer layers and having a ratio of leaflet thickness (μ
m) to number of layers of fluoropolymer of less than about 5, the leaflet maintaining substantially unchanged performance after actuation of the leaflet to at least 40 million cycles.- View Dependent Claims (11, 12, 13, 14, 15, 16, 17)
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18. A method of forming a leaflet of an implantable article for regulating blood flow direction in a human patient, the method comprising:
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providing 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; and bringing more than one layer of the composite material into contact with additional layers of the composite material by wrapping a sheet of the composite material with a starting and ending point defined as an axial seam adhered to itself. - View Dependent Claims (19, 20, 21)
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- 22. An implantable article for regulating blood flow direction in a human patient, the article comprising a polymeric leaflet having a thickness of less than about 100 μ
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25. An implantable article for regulating blood flow direction in a human patient, comprising:
a leaflet comprising 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. - View Dependent Claims (26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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56. An implantable article for regulating blood flow direction in a human patient, the implantable article comprising:
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a support structure; a leaflet supported on the support structure and movable between open and closed positions to regulate blood flow through the implantable article; and a cushion member located between at least a portion of the support structure and at least a portion of the leaflet, wherein the cushion member is formed from a composite material with at least one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores. - View Dependent Claims (57, 58, 59, 60, 61, 62, 63, 64, 65, 66)
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67. An implantable article for regulating blood flow direction in a human patient, the implantable article comprising:
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a generally annular shaped support structure, the support structure having a first end and an opposite second end, the first end having a longitudinally extending post; a sheet of leaflet material extending along an outer periphery of the support structure and forming a first leaflet and a second leaflet each extending along opposite sides of the post; and a cushion member coupled to the post to provide a cushion between the post and the leaflets. - View Dependent Claims (68)
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69. An implantable article for regulating blood flow direction in a human patient, the implantable article comprising:
a leaflet comprising 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 composite material comprising less than about 80% fluoropolymer by weight.
Specification