Methods of making a prosthetic valve with a durable high strength polymer composite leaflet

• US 9,770,327 B2
• Filed: 01/16/2015
• Issued: 09/26/2017
• 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.
• Primary Examiner(s): Cigna, Jacob
• Application Number:
  US14/598,587
• Publication Number:
  US 20150144262A1
• Time in Patent Office: 984 Days
• 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

Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Claims

1. A method of making a prosthetic valve, 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, 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 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, a method of making the composite material comprising;

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

filling the pores of the fluoropolymer layer; and

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

2. The method of claim 1, further comprising polymerizing the elastomer within the pores of the fluoropolymer layer.

3. A method of making a prosthetic valve, 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, 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 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,

a method of making the composite material comprising delivering the elastomer via a dispersion to fill the pores of the fluoropolymer layer.

4. The method of claim 3, further comprising polymerizing the elastomer within the pores of the fluoropolymer layer.

5. A method of making a prosthetic valve, 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, 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 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,

a method of making the composite material comprising bringing the at least one fluoropolymer layer into contact with a sheet of the elastomer under conditions of heat and/or pressure that allows the elastomer to fill the pores of the fluoropolymer layer.

6. The method of claim 5, further comprising polymerizing the elastomer within the pores of the fluoropolymer layer.

7. A method of making a prosthetic valve, 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, each leaflet including at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and TFE/PMVE copolymer present in the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the TFE/PMVE copolymer between each of the at least three layers of composite material, a method of making the composite material comprising;

dissolving the TFE/PMVE copolymer in a solvent suitable to create a solution to fill the pores of the fluoropolymer layer;

filling the pores of the fluoropolymer layer; and

allowing the solvent to evaporate so that the TFE/PMVE copolymer remains in the pores of the fluoropolymer layer.

8. A method of making a heart implant device, comprising:

providing 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 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, a method of making the composite material comprising;

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

filling the pores of the fluoropolymer layer; and

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

9. A method of making a heart implant device, comprising:

providing at least three layers of a composite material, the composite material including a fluoropolymer layer having a plurality of pores and TFE/PMVE copolymer present in the pores of the fluoropolymer layer, the at least three layers of composite material being coupled together with a layer of the TFE/PMVE copolymer between each of the at least three layers of composite material, a method of making the composite material comprising;

dissolving TFE/PMVE copolymer in a solvent suitable to create a solution to fill the pores of the fluoropolymer layer;

filling the pores of the fluoropolymer layer; and

allowing the solvent to evaporate so that the TFE/PMVE copolymer remains in the pores of the fluoropolymer layer.