COHERENT SINGLE LAYER HIGH STRENGTH SYNTHETIC POLYMER COMPOSITES FOR PROSTHETIC VALVES

• US 20180008406A1
• Filed: 09/22/2017
• Published: 01/11/2018
• Est. Priority Date: 04/01/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Finney, Bill R., Gassler, Paul D., Hartman, Cody L., Walsh, Peter J.
• Granted Patent: US 10,548,724 B2
• Time in Patent Office: Days
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• 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 27/12 containing fluorine atoms
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

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.

Claims

1. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame, the leaflet including at least one coherent single layer and an elastomeric material, wherein the at least one coherent single layer comprises a fluoropolymer and the elastomeric material comprises a TFE/PMVE copolymer.

2. The prosthetic valve of claim 1, wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and from about 60 to about 20 weight percent tetrafluoroethylene and wherein the fluoropolymer is ePTFE.

3. The prosthetic valve of claim 2, wherein the TFE/PMVE copolymer consisting essentially of between about 40 and about 80 weight percent perfluoromethyl vinyl ether and complementally between about 60 and about 20 weight percent tetrafluoroethylene.

4. The prosthetic valve of claim 1, wherein the leaflet has a light transmission of more than 60% at a 550 μ

m wavelength.

5. The prosthetic valve of claim 4, wherein the leaflet has a light transmission of more than 75% at a 550 μ

m wavelength.

6. The prosthetic valve of claim 5, wherein the leaflet has a light transmission of more than 90% at a 550 μ

m wavelength.

7. A prosthetic valve of claim 1, wherein the leaflet has a liquid pickup of less than 10%.

8. The prosthetic valve of claim 7, wherein the leaflet has a liquid pickup of less than 5%.

9. The prosthetic valve of claim 8, wherein the leaflet has a liquid pickup of less than 3%.

10. The prosthetic valve of claim 1, wherein the fluoropolymer comprises pores and the elastomeric material is present in the pores of the fluoropolymer such that the at least one coherent single layer is impermeable and wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2.

11. The prosthetic valve of claim 10, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.5.

12. The prosthetic valve of claim 11, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.3.

13. The prosthetic valve of claim 1, wherein the fluoropolymer is PTFE.

14. The prosthetic valve of claim 13, wherein the PTFE is ePTFE.

15. The prosthetic valve of claim 1, wherein the fluoropolymer is PTFE and wherein the prosthetic valve is operable to be a prosthetic heart valve.

16. The prosthetic valve of claim 15, wherein the frame is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site.

17. The prosthetic valve of claim 16, wherein the PTFE is ePTFE.

18. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame and movable between open and closed positions, the leaflet comprising at least one coherent single layer comprising an elastomeric material and a synthetic polymer, wherein the leaflet is impermeable, and wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.

19. The prosthetic valve of claim 18, comprising only one coherent single layer.

20. The prosthetic valve of claim 19, wherein the leaflet has a break force of greater than about 1 N/mm.

21. The prosthetic valve of claim 20, wherein the leaflet has a break force of greater than about 2 N/mm.

22. The prosthetic valve of claim 21, wherein the leaflet has a break force of greater than about 3 N/mm.

23. The prosthetic valve of claim 19, wherein the leaflet has a thickness of less than about 1 micron.

24. The prosthetic valve of claim 18, wherein the leaflet comprises elastomeric material by weight in a range from about 35% to about 90%.

25. The prosthetic valve of claim 18, wherein the elastomeric material is selected from the group consisting of silicones, fluoroelastomers, urethanes, and mixtures thereof.

26. The prosthetic valve of claim 18, wherein the elastomeric material is a copolymer of TFE/PMVE.

27. The prosthetic valve of claim 26, wherein the leaflet is impermeable.

28. The prosthetic valve of claim 27, wherein the TFE/PMVE copolymer comprises from about 40 to about 80 weight percent perfluoromethyl vinyl ether and complementally from about 60 to about 20 weight percent tetrafluoroethylene.

29. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame and the leaflet including at least one coherent single layer and an elastomeric material, the at least one coherent single layer having pores and is a synthetic polymer, the elastomeric material being present in the pores such that the at least one coherent single layer is impermeable, wherein the at least one coherent single layer is expanded fluoropolymer, wherein the elastomeric material is a TFE/PMVE copolymer, and wherein the prosthetic valve is operable to be a prosthetic heart valve.

30. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame, the leaflet comprising at least one coherent single layer and an elastomeric material, wherein the at least one coherent single layer is a synthetic polymer, wherein the leaflet is impermeable, wherein the leaflet has a compression set of less than 10%.

31. The prosthetic valve of claim 30, wherein the leaflet has a compression set of less than 5%.

32. The prosthetic valve of claim 31, wherein the leaflet has a compression set of less than 1%.