Methods of making durable multi-layer high strength polymer composite suitable for implant and articles produced therefrom

• US 10,342,658 B2
• Filed: 05/01/2017
• Issued: 07/09/2019
• 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.
• Primary Examiner(s): Aftergut, Jeffry H
• Application Number:
  US15/583,766
• Publication Number:
  US 20170231758A1
• Time in Patent Office: 799 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• 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: C09J 123/28 by reaction with halogens or compounds containing halogen C09J123/32 takes precedence

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.

Claims

1. A method of forming a leaflet of an implantable article for regulating blood flow direction in a human patient, the method comprising:

providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m and an elastomer present in the pores;

bringing one layer of the sheet of the composite material into contact with additional layers of the sheet of the composite material;

bonding the layers of the composite material together via the elastomer; and

forming a leaflet from the bonded layers of composite material.

2. The method of claim 1, wherein bringing one layer of the sheet of the composite material into contact with additional layers of the sheet of the composite material comprises wrapping the sheet of the composite material generally circumferentially about a mandrel.

3. The method of claim 1, wherein bringing one layer of a sheet of the composite material into contact with additional layers of the sheet of the composite material comprises bringing one layer of a sheet of the composite material into contact with additional layers of the sheet of the composite material to provide a ratio of thickness (μ

m) to number of fluoropolymer layers of less than 5.

4. The method of claim 1, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 1 μ

m.

5. The method of claim 1, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 0.10 μ

m.

6. The method of claim 1, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that are defined by fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μ

m.

7. The method of claim 1, wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a fluoroelastomer.

8. The method of claim 1, wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a TFE/PMVE copolymer.

9. The method of claim 1, 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.

10. The method of claim 1, wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a urethane.

11. A method of forming a leaflet of an implantable article for regulating blood flow direction in a human patient, the method comprising:

providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m and an elastomeric material present in the pores;

bringing one layer of the composite material into contact with additional layers of the composite material;

bonding the layers of composite material together via the elastomeric material; and

forming a leaflet from the bonded layers of composite material.

12. The method of claim 11, wherein bringing one layer of the sheet of a composite material into contact with additional layers of the sheet of the composite material comprises bringing one layer of a sheet of the composite material into contact with additional layers of the sheet of the composite material to provide a ratio of thickness (μ

m) to number of fluoropolymer layers of less than 5.

13. The method of claim 11, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 1 μ

m.

14. The method of claim 11, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 0.10 μ

m.

15. The method of claim 11, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that are defined by fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μ

m.

16. The method of claim 11, wherein providing a composite material having an elastomer comprises providing a composite material having an elastomer that is a fluoroelastomer.

17. The method of claim 11, wherein providing a composite material having an elastomeric material comprises providing a composite material having an elastomeric material that is a TFE/PMVE copolymer.

18. A method of forming a leaflet of an implantable article for regulating blood flow direction in a human patient, the method comprising:

providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m and TFE/PMVE present in the pores;

bringing one layer of the composite material into contact with additional layers of the composite material;

bonding the layers of composite material together via the TFE/PMVE; and

forming a leaflet from the bonded layer of the composite material.

19. The method of claim 18, wherein bringing one layer of a sheet of the composite material into contact with additional layers of the sheet of the composite material comprises bringing one layer of a sheet of the composite material into contact with additional layers of the sheet of the composite material to provide a ratio of thickness (μ

m) to number of fluoropolymer layers of less than 5.

20. The method of claim 18, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 1 μ

m.

21. The method of claim 18, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 5 μ

m comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that have a pore size that is less than 0.10 μ

m.

22. The method of claim 18, wherein providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores comprises providing a sheet of a composite material having more than one fluoropolymer layer having a plurality of pores that are defined by fibrils, wherein a diameter of a majority of the fibrils is less than about 1 μ

m.