METHODS OF MAKING A DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR PROSTHETIC VALVES

• US 20150135537A1
• Filed: 01/16/2015
• Published: 05/21/2015
• 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., Gassler, Paul D., Hartman, Cody L., Walsh, Peter J.
• Granted Patent: US 10,653,518 B2
• Time in Patent Office: Days
• US Class Current: 29/890.124
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2240/005 Templates
• CPC Class Codes: A61L 2420/04 Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10T 29/49412 with assembly, disassembly or composite article making

Abstract

Methods are presented that provide a thin, biocompatible, high-strength, composite material that is suitable for use in prosthetic valves. The composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to prosthetic valve leaflets. The composite material includes more than one porous expanded fluoropolymer layer and an elastomer present in the pores of the porous expanded fluoropolymer.

Claims

1. A method of making a leaflet of a prosthetic valve, the method comprising:

providing a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in 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 adhered to itself at a seam.

2. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising adhering the more than one layer of the composite material to an adjacent layer of the composite material.

3. The method of making a leaflet of a prosthetic valve as set forth in claim 2, further comprising:

disposing a layer of the elastomer between the more than one layer of the composite material and the adjacent layer of the composite material; and

adhering the more than one layer of the composite material to the adjacent layer of the composite material via the layer of the elastomer.

4. The method of making a leaflet of a prosthetic valve as set forth in claim 2, further comprising:

disposing a layer of the elastomer between the more than one fluoropolymer layer; and

adhering the more than one fluoropolymer layer to an adjacent fluoropolymer layer via the layer of the elastomer.

5. The method of making a leaflet of a prosthetic valve as set forth in claim 3, further comprising:

disposing a layer of the elastomer between the more than one fluoropolymer layer; and

adhering the more than one fluoropolymer layer to an adjacent fluoropolymer layer via the layer of the elastomer.

6. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising:

providing the composite material as a sheet; and

wrapping the sheet generally circumferentially.

7. The method of making a leaflet of a prosthetic valve as set forth in claim 2, further comprising providing the composite material as a contiguous sheet.

8. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein bringing more than one layer of the composite material into contact with additional layers of the composite material comprises bringing more than one layer of the composite material into contact with additional layers of the composite material such that a ratio of leaflet thickness measured in μ

m to a number of fluoropolymer layers is less than 5.

9. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising:

dissolving an elastomer in a solvent suitable to create a solution to fill the pores of the more than one fluoropolymer layer;

filling the pores of the more than one fluoropolymer layer; and

allowing the solvent to evaporate so that the elastomer remains in the pores of the more than one fluoropolymer layer.

10. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising delivering the elastomer via a dispersion to fill the pores of the more than one fluoropolymer layer.

11. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising bringing the more than one fluoropolymer layer into contact with a sheet of the elastomer under conditions of heat or pressure that allow the elastomer to be deposited into the pores of the more than one fluoropolymer layer.

12. The method of making a leaflet of a prosthetic valve as set forth in claim 1, further comprising polymerizing the elastomer within the pores of the more than one fluoropolymer layer.

13. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein bringing more than one layer of the composite material into contact with additional layers of the composite material comprises bringing more than one layer of the composite material into contact with additional layers of the composite material such that a leaflet thickness is less than 100 μ

m.

14. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein providing an elastomer comprises providing an elastomer that is a fluoroelastomer.

15. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one PTFE layer.

16. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one ePTFE layer.

17. The method of making a leaflet of a prosthetic valve as set forth in claim 1, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one ePTFE layer having a matrix tensile strength in at least one direction greater than about 96 MPa.

18. A method of making a prosthetic valve, the method comprising:

providing a support structure defining a plurality of posts; and

coupling a leaflet to each of the plurality of posts, each leaflet movable between open and closed positions,

a method of making the leaflet comprising;

providing a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in 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 adhered to itself at a seam defining a multi-layered composite.

19. The method of making a prosthetic valve as set forth in claim 18, further comprising cutting the leaflet from the multi-layered composite.

20. The method of making a prosthetic valve as set forth in claim 18, further comprising adhering the more than one layer of the composite material to an adjacent layer of the composite material.

21. The method of making a prosthetic valve as set forth in claim 20, further comprising:

disposing a layer of the elastomer between the more than one layer of the composite material and the adjacent layer of the composite material; and

adhering the more than one layer of the composite material to the adjacent layer of the composite material via the layer of the elastomer.

22. The method of making a prosthetic valve as set forth in claim 20, further comprising:

disposing a layer of the elastomer between the more than one fluoropolymer layer; and

adhering the more than one fluoropolymer layer to an adjacent fluoropolymer layer via the layer of the elastomer.

23. The method of making a prosthetic valve as set forth in claim 21, further comprising:

disposing a layer of the elastomer between the more than one fluoropolymer layer; and

adhering the more than one fluoropolymer layer to an adjacent fluoropolymer layer via the layer of the elastomer.

24. The method of making a prosthetic valve as set forth in claim 18, further comprising:

providing the composite material as a sheet; and

wrapping the sheet generally circumferentially.

25. The method of making a prosthetic valve as set forth in claim 20, further comprising providing the composite material as a contiguous sheet.

26. The method of making a prosthetic valve as set forth in claim 18, wherein bringing more than one layer of the composite material into contact with additional layers of the composite material comprises bringing more than one layer of the composite material into contact with additional layers of the composite material such that a ratio of leaflet thickness measured in μ

m to a number of fluoropolymer layers is less than 5.

27. The method of making a prosthetic valve as set forth in claim 18, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising:

dissolving an elastomer in a solvent suitable to create a solution to fill the pores of the more than one fluoropolymer layer;

filling the pores of the more than one fluoropolymer layer; and

allowing the solvent to evaporate so that the elastomer remains in the pores of the more than one fluoropolymer layer.

28. The method of making a prosthetic valve as set forth in claim 18, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising delivering the elastomer via a dispersion to fill the pores of the more than one fluoropolymer layer.

29. The method of making a prosthetic valve as set forth in claim 18, further comprising a method of providing elastomer in the pores of the more than one fluoropolymer layer comprising bringing the more than one fluoropolymer layer into contact with a sheet of the elastomer under conditions of heat or pressure that allow the elastomer to be deposited into the pores of the more than one fluoropolymer layer.

30. The method of making a prosthetic valve as set forth in claim 18, further comprising polymerizing the elastomer within the pores of the more than one fluoropolymer layer.

31. The method of making a prosthetic valve as set forth in claim 18, wherein bringing more than one layer of the composite material into contact with additional layers of the composite material comprises bringing more than one layer of the composite material into contact with additional layers of the composite material such that a leaflet thickness is less than 100 μ

m.

32. The method of making a prosthetic valve as set forth in claim 18, wherein providing an elastomer comprises providing an elastomer that is a fluoroelastomer.

33. The method of making a prosthetic valve as set forth in claim 18, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one PTFE layer.

34. The method of making a prosthetic valve as set forth in claim 18, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one ePTFE layer.

35. The method of making a prosthetic valve as set forth in claim 18, wherein providing a composite material having more than one fluoropolymer layer comprises providing a composite material having more than one ePTFE layer having a matrix tensile strength in at least one direction greater than about 96 MPa.