DURABLE MULTI-LAYER HIGH STRENGTH POLYMER COMPOSITE SUITABLE FOR IMPLANT AND ARTICLES PRODUCED THEREFROM

• US 20130166021A1
• Filed: 01/25/2013
• Published: 06/27/2013
• Est. Priority Date: 04/01/2011
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Hartman, Cody L., Bruchman, William C.
• Application Number:
  US13/750,649
• Publication Number:
  US 20130166021A1
• Time in Patent Office: Days
• US Class Current: 623/2.12
• 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

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 and an elastomer substantially filling substantially all of the pores of the porous expanded fluoropolymer.

Claims

1. An implantable article for regulating blood flow direction in a human patient, comprising:

a leaflet having a thickness and formed from a composite material having more than one fluoropolymer layer having a plurality of pores and an elastomer present in substantially all of the pores of the more than one fluoropolymer layer, the leaflet having a ratio of leaflet thickness (μ

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

2. The implantable article as set forth in claim 1, wherein the ratio of leaflet thickness (μ

m) to number of layers of fluoropolymer of less than about 3.

3. The implantable article as set forth in claim 1, wherein the ratio of leaflet thickness (μ

m) to number of layers of fluoropolymer of less than about 1.

4. The implantable article as set forth in claim 1, wherein the ratio of leaflet thickness (μ

m) to number of layers of fluoropolymer of less than about 0.5.

7. The implantable article as set forth in claim 1, wherein the leaflet has at least 10 layers and a composite material comprising less than about 50% fluoropolymer by weight.

8. The implantable article as set forth in claim 7, wherein the leaflet has a thickness less than 100 μ

m.

9. The implantable article as set forth in claim 8, wherein the leaflet has a bending modulus of less than about 100 MPa.

13. The implantable article as set forth in claim 1, wherein the leaflet is operatively coupled to a support frame and movable between the closed and open configurations relative to the support frame.

14. The implantable article as set forth in claim 13, wherein the support frame is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site.

17. The implantable article as set forth in claim 1, wherein the leaflet encompasses a radiopaque element.

5-6. -6. (canceled)

10-12. -12. (canceled)

15-16. -16. (canceled)