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

Patent metadata

Field	Value
Publication number	US-9770327-B2
Application number	US-201514598587-A
Country	US
Kind code	B2
Filing date	Jan 16, 2015
Priority date	Apr 1, 2011
Publication date	Sep 26, 2017
Grant date	Sep 26, 2017

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.

First claim

What is claimed is:

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.

Assignees

• Gore & Ass

Inventors

• Bruchman William C
• Gassler Paul D
• Hartman Cody L
• Walsh Peter J

Classifications

• A61L2430/20

  for reconstruction of the heart, e.g. heart valves · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/2418

  Scaffolds therefor, e.g. support stents · CPC title

• A61L27/40

  Composite materials, i.e. containing one material dispersed in a matrix of the same or different material · CPC title

• A61F2230/00

  Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof · CPC title