DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM
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.
1 . A valve, comprising:
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 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 (μm) to number of layers of fluoropolymer of less than about 5.
2 . The valve of claim 1 , wherein the ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 3.
3 . The valve of claim 1 , wherein the ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 1.
4 . The valve of claim 1 , wherein the ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 0.5.
5 . The valve of claim 1 , wherein the leaflet has at least 10 layers and a composite material comprising less than about 50% fluoropolymer by weight.
6 . The valve of claim 5 , wherein the leaflet has a thickness less than 100 μm.
7 . The valve of claim 6 , wherein the leaflet has a bending modulus of less than about 100 MPa.
8 . The valve of claim 1 , wherein the pores have a pore size that is less than about 5 μm.
9 . The valve of claim 1 , wherein the pores have a pore size that is less than about 1 μm.
10 . The valve of claim 1 , wherein the pores have a pore size that is less than about 0.10 μm.
11 . The valve of claim 1 , wherein the more than one fluoropolymer layer comprises fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μm.
12 . The valve of claim 1 , wherein the elastomer is a fluoroelastomer.
13 . The valve of claim 1 , wherein the elastomer is a urethane.
14 . The valve of claim 1 , wherein the elastomer is a TFE/PMVE copolymer.
15 . The valve of claim 14 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.
16 . A valve, comprising:
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 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, each leaflet having a thickness of less than about 100 μm.
17 . The valve of claim 16 , wherein the leaflet includes at least 10 layers of the composite material.
18 . The valve of claim 16 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 5.
19 . The valve of claim 16 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 3.
20 . The valve of claim 16 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 1.
21 . The valve of claim 16 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 0.5.
22 . The valve of claim 16 , wherein the leaflet has at least 10 layers and a composite material comprising less than about 50% fluoropolymer by weight.
23 . The valve of claim 22 , wherein the leaflet has a thickness less than about 100 μm.
24 . The valve of claim 23 , wherein the leaflet has a bending modulus of less than about 100 MPa.
25 . The valve of claim 16 , wherein the pores have a pore size that is less than about 5 μm.
26 . The valve of claim 16 , wherein the pores have a pore size that is less than about 1 μm.
27 . The valve of claim 16 , wherein the pores have a pore size that is less than about 0.10 μm.
28 . The valve of claim 16 , wherein the more than one fluoropolymer layer comprises fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μm.
29 . The valve of claim 16 , wherein the elastomer is a fluoroelastomer.
30 . The valve of claim 16 , wherein the elastomer is a urethane.
31 . The valve of claim 29 , wherein the elastomer is a TFE/PMVE copolymer.
32 . The valve of claim 31 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.
33 . A valve, comprising:
a support structure including a leaflet support frame having a plurality of substantially parabolically shaped top edges and posts, and
a leaflet being supported on each parabolically shaped top edge and posts, each leaflet defining a free edge not coupled to the support structure, each leaflet being movable between open and closed positions, each leaflet including at least two layers of a composite material comprising 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.
34 . The valve of claim 33 , wherein at least one layer of the at least two layers of a composite material is coupled to an inner surface of the support structure and wherein at least one layer of the at least two layers of a composite material is coupled to an outer surface of the support structure.
35 . The valve of claim 33 , wherein each leaflet having a thickness of less than about 100 μm.
36 . The valve of claim 33 , wherein the leaflet includes at least 10 layers of the composite material.
37 . The valve of claim 33 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 5.
38 . The valve of claim 33 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 3.
39 . The valve of claim 33 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 1.
41 . The valve of claim 33 , wherein a ratio of leaflet thickness (μm) to number of layers of fluoropolymer of less than about 0.5.
42 . The valve of claim 33 , wherein the leaflet has at least 10 layers and a composite material comprising less than about 50% fluoropolymer by weight.
43 . The valve of claim 42 , wherein the leaflet has a thickness less than about 100 μm.
44 . The valve of claim 43 , wherein the leaflet has a bending modulus of less than about 100 MPa.
45 . The valve of claim 33 , wherein the pores have a pore size that is less than about 5 μm.
46 . The valve of claim 33 , wherein the pores have a pore size that is less than about 1 μm.
47 . The valve of claim 33 , wherein the pores have a pore size that is less than about 0.10 μm.
48 . The valve of claim 33 , wherein the more than one fluoropolymer layer comprises fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μm.
49 . The valve of claim 33 , wherein the elastomer is a fluoroelastomer.
50 . The valve of claim 33 , wherein the elastomer is a urethane.
51 . The valve of claim 49 , wherein the elastomer is a TFE/PMVE copolymer.
52 . The valve of claim 51 , wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.
53 . A method of forming a leaflet of an implantable article for regulating blood flow direction in a human patient, the method comprising:
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.
54 . The method of claim 53 , wherein wrapping a sheet of the composite material comprises wrapping a sheet of the composite material generally radially with the starting and ending point defined as the axial seam adhered to itself.
55 . The method of claim 53 , wherein wrapping a sheet of the composite material comprises wrapping a sheet of the composite material to a ratio of thickness (μm) to number of layers of fluoropolymer of less than about 5.
56 . The method of claim 53 , wherein providing a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than about 5 μm.
57 . The method of claim 53 , wherein providing a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than about 1 μm.
58 . The method of claim 53 , wherein providing a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than about 0.10 μm.
59 . The method of claim 53 , wherein providing a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a composite material having more than one fluoropolymer layer having a plurality of pores defined by fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μm.
60 . The method of claim 53 , wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a fluoroelastomer.
61 . The method of claim 53 , wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a TFE/PMVE copolymer.
62 . The method of claim 53 , wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a TFE/PMVE copolymer, wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.
63 . The method of claim 53 , wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a urethane.