PTFE composite multi-layer material

• US 20070260268A1
• Filed: 02/14/2006
• Published: 11/08/2007
• Est. Priority Date: 02/14/2005
• Status: Active Grant

• Current Assignee: Osteogenics Biomedical, Inc. (Envista Holdings Corporation)
• Original Assignee: Barry Bartee, Chad Bartee
• Inventors: Bartee, Chad, Bartee, Barry
• Granted Patent: US 7,789,888 B2
• Time in Patent Office: Days
• 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 and 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; and

a second layer formed from an open structured material, wherein surfaces of the first and second layers are attached at a common interface.

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, wherein the first and second layers are attached by stitching at least a portion of said first layer to at least a portion of said second layer.

24. The composite multi-layer material of claim 1, wherein the first and second layers are attached using hydraulic pressure.

25. The composite multi-layer material of claim 1, wherein the first and second layers are attached using a biocompatible adhesive.

26. The composite multi-layer material of claim 1, wherein the first and second layers are attached using heat.

27. The composite multi-layer material of claim 1, wherein said composite multi-layer material forms a tube structure wherein said first layer forms the tube'"'"'s interior surface and said second layer forms the tube'"'"'s exterior surface.

28. 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.

29. 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 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.

30. The device according to claim 29, wherein the soft tissue for repair is in the chest.

31. The device according to claim 29, wherein the soft tissue for repair is in the abdomen.

32. A device for vascular tissue repair and grafting comprising a first and second layer attached to form a tube structure, wherein said first layer comprising unsintered substantially unexpanded polytetrafluoroethylene polymer 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 forms the interior of the tube structure and wherein said second layer comprising an open structured material forms the exterior of the tube structure.

33. A method of treating a patient in need of tissue repair, comprising contacting the tissue in need of repair with a composite multi-layer material comprising:

a first layer formed from unsintered substantially unexpanded polytetrafluoroethylene polymer and 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; and

a second layer formed from an open structured material, wherein surfaces of the first and second layers are attached at a common interface.

34. The method of claim 33, wherein the nominal channel size is less than 2 micrometers.

35. The method of claim 33, wherein the nominal channel size is less than 0.5 micrometers.

36. The method of claim 33, wherein the nominal channel size is less than 0.2 micrometers.

37. The method of claim 33, wherein the first layer has at least one hydrophobic surface.

38. The method of claim 33, wherein the first layer has at least one hydrophilic surface.

39. The method of claim 33, wherein the open structured material includes unexpanded PTFE.

40. The method of claim 39, wherein the open structured material forms a non-woven flatsheet.

41. The method of claim 39, wherein the open structured material forms a woven flatsheet.

42. The method of claim 39, wherein the open structured material forms a mesh.

43. The method of claim 33, wherein the open structured material includes polypropylene.

44. The method of claim 43, wherein the open structured material forms a non-woven flatsheet.

45. The method of claim 43, wherein the open structured material forms a woven flatsheet.

46. The method of claim 43, wherein the open structured material forms a mesh.

47. The method of claim 33, wherein the open structured material includes a resorbable polymer.

48. The method of claim 47, wherein the open structured material forms a non-woven flatsheet.

49. The method of claim 47, wherein the open structured material forms a woven flatsheet.

50. The method of claim 47, wherein the open structured material forms a mesh.

51. The method of claim 33, wherein the open structured material comprises a non-resorbable polymer.

52. The method of claim 51, wherein the open structured material forms a non-woven flatsheet.

53. The method of claim 51, wherein the open structured material forms a woven flatsheet.

54. The method of claim 51, wherein the open structured material forms a mesh.

55. The method of claim 33, wherein the first and second layers are attached by stitching at least a portion of said first layer to at least a portion of said second layer.

56. The method of claim 33, wherein the first and second layers are attached using hydraulic pressure.

57. The method of claim 33, wherein the first and second layers are attached using a biocompatible adhesive.

58. The method of claim 33, wherein the first and second layers are attached using heat.

59. The method of claim 33, wherein said composite multi-layer material forms a tube structure wherein said first layer forms the tube'"'"'s interior surface and said second layer forms the tube'"'"'s exterior surface.

60. The method of claim 33, wherein the polytetrafluoroethylene polymer of the first layer has a density in the range of 1.45 gm/cc to 1.55 gm/cc.

61. The method of claim 33, wherein the tissue in need of repair comprises a hernia.

62. The method of claim 33, wherein the tissue in need or repair comprises an aneurysm.

63. The method of claim 62, wherein the aneurysm comprises an abdominal aortic aneurysm.

64. The method of claim 33, wherein the patient is a human.