Durable high strength polymer composite suitable for implant and articles produced therefrom

• US 8,961,599 B2
• Filed: 04/01/2011
• Issued: 02/24/2015
• Est. Priority Date: 04/01/2011
• Status: Expired due to Fees

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Gassler, Paul D., Hartman, Cody L., Walsh, Peter J., White, Charles F.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US13/078,774
• Publication Number:
  US 20120253453A1
• Time in Patent Office: 1,425 Days
• Field of Search: 623/2.42
• US Class Current: 623/2.42
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/00 Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/025 Other specific inorganic materials not covered by A61L27/04 - A61L27/12
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/00 Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a halogen; Compositions of derivatives of such polymers

Abstract

A thin, biocompatible, high-strength, composite material is disclosed that is suitable for use in various implanted configurations. In one aspect, 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 a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous expanded fluoropolymer, and the composite material comprising less than about 80% fluoropolymer by weight.

Claims

1. A prosthetic valve comprising:

a support structure including a plurality of posts; and

a leaflet coupled to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the elastomer between each of the at least three layers of composite material.

2. The prosthetic valve of claim 1, wherein the composite material comprises less than about 80% fluoropolymer by weight.

3. The prosthetic valve of claim 1, wherein the composite material comprises less than about 60% fluoropolymer by weight.

4. The prosthetic valve of claim 1, wherein the composite material comprises less than about 50% fluoropolymer by weight.

5. The prosthetic valve of claim 1, wherein the elastomer is a fluoroelastomer.

6. The prosthetic valve of claim 5, wherein the elastomer is a TFE/PMVE copolymer.

7. The prosthetic valve of claim 6, wherein the copolymer consists essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.

8. The prosthetic valve of claim 1, wherein fluoropolymer of each fluoropolymer layer is PTFE.

9. The prosthetic valve of claim 8, wherein the PTFE is ePTFE.

10. The prosthetic valve of claim 9, wherein each fluoropolymer layer has a matrix tensile strength in at least one direction greater than about 96 MPa.

11. The prosthetic valve of claim 9, wherein the composite material comprises less than about 50% fluoropolymer by weight.

12. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 350 μ

m.

13. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 300 μ

m.

14. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 200 μ

m.

15. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 100 μ

m.

16. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 50 μ

m.

17. The prosthetic valve of claim 1, wherein each leaflet has a thickness of less than about 25 μ

m.

18. The prosthetic valve of claim 1, wherein the EOA across the prosthetic valve is maintained within about 10% after about 40 million cycles.

19. The prosthetic valve of claim 1, wherein a regurgitant fraction across the prosthetic valve is maintained below about 15% after about 40 million cycles.

20. The prosthetic valve of claim 1, wherein each leaflet is devoid of edge delamination or hole formation after about 40 million cycles.

21. A prosthetic heart valve comprising:

a support structure including a plurality of posts; and

a leaflet coupled to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the elastomer between each of the at least three layers of composite material,

wherein the fluoropolymer layer of the composite material has a thickness of less than 12 microns.

22. A prosthetic valve comprising:

a support structure including a plurality of posts; and

a leaflet coupled to each of the plurality of posts, each leaflet movable between open and closed positions, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and an elastomer in a portion of the pores, the at least three layers of composite material being coupled together with a layer of the elastomer between each of the at least three layers of composite material, wherein each fluoropolymer layer has a thickness that is less than about 6 microns.

23. The prosthetic valve of claim 22, wherein each leaflet comprises less than 80% fluoropolymer by weight.

24. The prosthetic valve of claim 22, wherein the elastomer is present in substantially all of the pores of the fluoropolymer layer.