PTFE composite multi-layer material

• US 7,789,888 B2
• Filed: 02/14/2006
• Issued: 09/07/2010
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: Osteogenics Biomedical, Inc. (Envista Holdings Corporation)
• Original Assignee: Barry K. Bartee, Chad M. Bartee
• Inventors: Bartee, Chad M., Bartee, Barry K.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/354,272
• Publication Number:
  US 20070260268A1
• Time in Patent Office: 1,666 Days
• Field of Search: 623 115- 154, 424/423, 606/151
• US Class Current: 606/151
• CPC Class Codes: A61B 2090/0816 for preventing adhesion
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• 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: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A composite multi-layer material may generally comprise a d-PTFE material combined with an open structured material (either resorbable or non-resorbable) creating a composite multi-layer material. Attachment of the layers may be accomplished by stitching layers of material, exertion of hydraulic or other pressure, application of a biocompatible adhesive or heat, or some combination of the foregoing. Use of a d-PTFE, unexpanded material has multiple alternative uses, including without limitation, placement on the visceral side of a hernia that may minimize or even eliminate the incidence of abdominal adhesions. Alternatively, the material may be used to create tubing sufficient as a graft for treating abdominal aortic aneurysms.

Claims

1. A composite multi-layer material comprising:

a first layer formed from unsintered substantially unexpanded polytetrafluoroethylene polymer having no measurable, repeatable internodal distance, having a density in a range of about 1.2 gm/cc to about 2.3 gm/cc and having a plurality of pores having a nominal channel size of less than 5 micrometers;

a second layer formed from an open structured material, wherein

surfaces of the first and second layers are attached at a common interface; and

a stitching that attaches at least a portion of the first layer to at least a portion of the second layer.

2. The composite multi-layer material of claim 1, wherein the nominal channel size is less than 2 micrometers.

3. The composite multi-layer material of claim 1, wherein the nominal channel size is less than 0.5 micrometers.

4. The composite multi-layer material of claim 1, wherein the nominal channel size is less than 0.2 micrometers.

5. The composite multi-layer material of claim 1, wherein the first layer has at least one hydrophobic surface.

6. The composite multi-layer material of claim 1, wherein the first layer has at least one hydrophilic surface.

7. The composite multi-layer material of claim 1, wherein the open structured material includes unexpanded PTFE.

8. The composite multi-layer material of claim 7, wherein the open structured material forms a non-woven flatsheet.

9. The composite multi-layer material of claim 7, wherein the open structured material forms a woven flatsheet.

10. The composite multi-layer material of claim 7, wherein the open structured material forms a mesh.

11. The composite multi-layer material of claim 1, wherein the open structured material includes polypropylene.

12. The composite multi-layer material of claim 11, wherein the open structured material forms a non-woven flatsheet.

13. The composite multi-layer material of claim 11, wherein the open structured material forms a woven flatsheet.

14. The composite multi-layer material of claim 11, wherein the open structured material forms a mesh.

15. The composite multi-layer material of claim 1, wherein the open structured material includes a resorbable polymer.

16. The composite multi-layer material of claim 15, wherein the open structured material forms a non-woven flatsheet.

17. The composite multi-layer material of claim 15, wherein the open structured material forms a woven flatsheet.

18. The composite multi-layer material of claim 15, wherein the open structured material forms a mesh.

19. The composite multi-layer material of claim 1, wherein the open structured material comprises a non-resorbable polymer.

20. The composite multi-layer material of claim 19, wherein the open structured material forms a non-woven flatsheet.

21. The composite multi-layer material of claim 19, wherein the open structured material forms a woven flatsheet.

22. The composite multi-layer material of claim 19, wherein the open structured material forms a mesh.

23. The composite multi-layer material of claim 1, further comprising a biocompatible adhesive that attaches the first and second layers.

24. The composite multi-layer material of claim 1, wherein said composite multi-layer material has a tube structure having in interior surface comprising said first layer and an exterior surface comprising said second layer.

25. The composite multi-layer material of claim 1, wherein the polytetrafluoroethylene polymer of the first layer has a density in the range of 1.45 gm/cc to 1.55 gm/cc.

26. A device for repairing soft tissue comprising a first and second layer attached to form a flat structure, wherein said first layer comprises unsintered substantially unexpanded polytetrafluoroethylene polymer having no measurable, repeatable internodal distance, having a density in a range of about 1.2 gm/cc to about 2.3 gm/cc and having a plurality of pores with a nominal channel size of less than 5 micrometers and wherein said second layer comprises an open structured material, and wherein a stitching attaches at least a portion of said first layer to at least a portion of said second layer.