Prosthetic repair fabric with erosion resistant edge

• US 20050027369A1
• Filed: 09/02/2004
• Published: 02/03/2005
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: Michael J Lee, Roger E. Darois, Stephen N. Eldridge, Valerie Vadurro
• Original Assignee: Michael J Lee, Roger E. Darois, Stephen N. Eldridge, Valerie Vadurro
• Inventors: Darois, Roger E., Eldridge, Stephen N., Lee, Michael J., Vadurro, Valerie
• Granted Patent: US 7,879,108 B2
• Time in Patent Office: Days
• US Class Current: 623/23.740
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence

Abstract

An implantable prosthesis is provided for repairing or augmenting anatomical weaknesses or defects, and is particularly suitable for the repair of soft tissue and muscle wall openings. The prosthesis may include a repair fabric that is constructed and arranged to allow tissue ingrowth and is susceptible to erosion into and the formation of adhesions with tissue and organs. One or more regions of the prosthesis may be configured to inhibit erosion into and/or the formation of adhesions with tissue and organs. The prosthesis may include an erosion resistant edge to buffer an edge of the fabric from the adjacent tissue or organs. The erosion resistant edge may be provided along an opening that is adapted to receive a tube-like structure, such as the esophagus.

Claims

1. An implantable prosthesis for repairing a tissue or muscle wall defect, the implantable prosthesis comprising:

a repair fabric that is susceptible to erosion into and the formation of adhesions with tissue and organs, the repair fabric including first and second surfaces and a fabric edge extending from the first surface to the second surface, the first surface adapted to face the tissue or muscle wall defect and the second surface adapted to face away from the defect; and

an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed on a portion of the first and second surfaces adjacent the fabric edge and extending from the first surface to the second surface over the fabric edge, the edge barrier having an inner surface that is spaced from the fabric edge in a direction normal to the fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.

2. The implantable prosthesis according to claim 1, wherein the repair fabric includes an opening that is adapted to receive a tube-like structure, the fabric edge including an opening edge that extends along the opening, the edge barrier extending about the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.

3. The implantable prosthesis according to claim 2, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.

4. The implantable prosthesis according to claim 2, wherein the opening is a partial opening that is adapted to partially surround a portion of the tube-like structure.

5. The implantable prosthesis according to claim 1, further comprising a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on at least a portion of the second surface of the repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the repair fabric is placed in the patient.

6. The implantable prosthesis according to claim 5, wherein the surface barrier is disposed on substantially the entire second surface of the repair fabric.

7. The implantable prosthesis according to claim 5, wherein the edge barrier is an integral extension of the surface barrier that is wrapped about the fabric edge.

8. The implantable prosthesis according to claim 5, wherein a portion of the surface barrier is disposed between the edge barrier and the second surface of the repair fabric.

9. The implantable prosthesis according to claim 1, wherein the edge barrier includes first and second barrier layers, the first barrier layer being disposed on the portion of the first surface of the repair fabric and extending beyond the fabric edge, the second barrier layer being disposed on the portion of the second surface of the repair fabric and extending beyond the fabric edge to overlie the first barrier layer, portions of the first and second barrier layers extending beyond the fabric edge being attached directly to each other to isolate the fabric edge and form the inner surface of the edge barrier spaced from the fabric edge.

10. The implantable prosthesis according to claim 9, wherein the second barrier layer includes a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on and covering the second surface of the repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the repair fabric is placed in the patient.

11. The implantable prosthesis according to claim 1, wherein the edge barrier includes a barrier layer that wraps about the fabric edge from the portion of the first surface of the repair fabric to the portion of the second surface of the repair fabric.

12. The implantable prosthesis according to claim 1, wherein the repair fabric has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

13. The implantable prosthesis according to claim 1, wherein the fabric edge includes an outer peripheral edge, and wherein the implantable prosthesis further comprises an outer edge barrier that extends about at least a portion of the outer peripheral edge to inhibit the formation of adhesions between the portion of the outer peripheral edge and adjacent tissue or organs.

14. The implantable prosthesis according to claim 1, wherein the repair fabric includes polypropylene mesh or PTFE mesh.

15. The implantable prosthesis according to claim 1, wherein the edge barrier is formed from ePTFE.

16. The implantable prosthesis according to claim 1, wherein the gap has a length of approximately 0.5 mm to approximately 2.5 mm in the normal direction.

17. The implantable prosthesis according to claim 16, wherein the gap has a length of approximately 0.5 mm to approximately 1.5 mm in the normal direction.

18. The implantable prosthesis according to claim 16, wherein the gap has a length of approximately 1 mm to approximately 2.5 mm in the normal direction.

19. The implantable prosthesis according to claim 1, wherein the edge barrier is softer than the repair fabric.

20. The implantable prosthesis according to claim 1, wherein the edge barrier is smoother than the repair fabric.

21. The implantable prosthesis according to claim 1, wherein the edge barrier is more deformable than the repair fabric.

22. The implantable prosthesis according to claim 21, wherein the inner surface of the edge barrier is adapted to collapse towards the fabric edge when a force normal to the fabric edge is applied to the edge barrier.

23. The implantable prosthesis according to claim 21, wherein the edge barrier is adapted to bend relative to the fabric edge when a force normal to the fabric edge is applied to the edge barrier.

24. The implantable prosthesis according to claim 1, wherein the fabric edge has an edge height and the edge barrier has an outer surface opposite the inner surface of the edge barrier, the outer surface having a surface height that is greater than the edge height.

25. The implantable prosthesis according to claim 1, wherein the edge barrier is constructed and arranged to isolate the fabric edge from the tissue and organs when the repair fabric is placed near the tissue or muscle wall defect.

26. The implantable prosthesis according to claim 1, wherein the repair fabric is substantially flat.

27. An implantable prosthesis for repairing a tissue or muscle wall defect, the implantable prosthesis comprising:

a repair fabric that is susceptible to the formation of adhesions with and erosion into tissue and organs, the repair fabric including first and second surfaces and a fabric edge extending from the first surface to the second surface, the first surface adapted to face the muscle or tissue wall defect and the second surface adapted to face away from the defect; and

an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions, the edge barrier being disposed at all times over the fabric edge, the edge barrier having an inner surface that is spaced from the fabric edge in a direction normal to fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.

28. The implantable prosthesis according to claim 27, wherein the repair fabric includes an opening that is adapted to receive a tube-like structure, the fabric edge including an opening edge that extends along the opening, the edge barrier extending about the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.

29. The implantable prosthesis according to claim 28, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.

30. The implantable prosthesis according to claim 28, wherein the opening is a partial opening that is adapted to partially surround a portion of the tube-like structure.

31. The implantable prosthesis according to claim 27, further comprising a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on at least a portion of the second surface of the repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the repair fabric is placed in the patient.

32. The implantable prosthesis according to claim 31, wherein the surface barrier is disposed on substantially the entire second surface of the repair fabric.

33. The implantable prosthesis according to claim 31, wherein the edge barrier is an integral extension of the surface barrier that is wrapped about the fabric edge.

34. The implantable prosthesis according to claim 31, wherein a portion of the surface barrier is disposed between the edge barrier and the second surface of the repair fabric.

35. The implantable prosthesis according to claim 27, wherein the edge barrier includes first and second barrier layers, the first barrier layer being disposed on the portion of the first surface of the repair fabric and extending beyond the fabric edge, the second barrier layer being disposed on the portion of the second surface of the repair fabric and extending beyond the fabric edge to overlie the first barrier layer, portions of the first and second barrier layers extending beyond the fabric edge being attached directly to each other to isolate the fabric edge and form the inner surface of the edge barrier spaced from the fabric edge.

36. The implantable prosthesis according to claim 35, wherein the second barrier layer includes a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on and covering the second surface of the repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the repair fabric is placed in the patient.

37. The implantable prosthesis according to claim 27, wherein the edge barrier includes a barrier layer that wraps about the fabric edge from the portion of the first surface of the repair fabric to the portion of the second surface of the repair fabric.

38. The implantable prosthesis according to claim 27, wherein the repair fabric has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

39. The implantable prosthesis according to claim 27, wherein the fabric edge includes an outer peripheral edge, and wherein the implantable prosthesis further comprises an outer edge barrier that extends about at least a portion of the outer peripheral edge to inhibit the formation of adhesions between the portion of the outer peripheral edge and adjacent tissue or organs.

40. The implantable prosthesis according to claim 27, wherein the repair fabric includes polypropylene mesh or PTFE mesh.

41. The implantable prosthesis according to claim 27, wherein the edge barrier is formed from ePTFE.

42. The implantable prosthesis according to claim 27, wherein the gap has a length of approximately 0.5 mm to approximately 2.5 mm in the normal direction.

43. The implantable prosthesis according to claim 42, wherein the gap has a length of approximately 0.5 mm to approximately 1.5 mm in the normal direction.

44. The implantable prosthesis according to claim 42, wherein the gap has a length of approximately 1 mm to approximately 2.5 mm in the normal direction.

45. The implantable prosthesis according to claim 27, wherein the edge barrier is softer than the repair fabric.

46. The implantable prosthesis according to claim 27, wherein the edge barrier is smoother than the repair fabric.

47. The implantable prosthesis according to claim 27, wherein the edge barrier is more deformable than the repair fabric.

48. The implantable prosthesis according to claim 47, wherein the inner surface of the edge barrier is adapted to collapse towards the fabric edge when a force normal to the fabric edge is applied to the edge barrier.

49. The implantable prosthesis according to claim 47, wherein the edge barrier is adapted to bend relative to the fabric edge when a force normal to the fabric edge is applied to the edge barrier.

50. The implantable prosthesis according to claim 27, wherein the fabric edge has an edge height and the edge barrier has an outer surface opposite the inner surface of the edge barrier, the outer surface having a surface height that is greater than the edge height.

51. The implantable prosthesis according to claim 27, wherein the edge barrier is constructed and arranged to isolate the fabric edge from the tissue and organs when the repair fabric is placed near the tissue or muscle wall defect.

52. The implantable prosthesis according to claim 27, wherein the repair fabric is substantially flat.