Implantable prosthesis

• US 8,956,373 B2
• Filed: 07/23/2010
• Issued: 02/17/2015
• Est. Priority Date: 08/02/2002
• Status: Expired due to Term

• Current Assignee: Davol Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ford, Steven Palmer, Torres, Donna Schultz
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/842,629
• Publication Number:
  US 20100286716A1
• Time in Patent Office: 1,670 Days
• Field of Search: 606/151, 606/192, 600/29, 600/30, 600/37, 602/44, 602/67, 602/76, 602/70, 128/95.1, 128/99.1, 623/23.72, 623/23.76, 623/11.11
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

An implantable prosthesis for repairing an anatomical defect, such as a tissue or muscle wall hernia, including an umbilical hernia, and for preventing the occurrence of a hernia at a small opening or weakness in a tissue or muscle wall, such as at a puncture tract opening remaining after completion of a laparoscopic procedure. The prosthesis includes a patch for covering or extending across the opening or weakness. At least one tether, such as a strap, extends from the patch and may be manipulated to position and/or to secure the patch relative to the opening or weakness in the tissue or muscle wall. The tether may be configured to extend through the defect and outside a patient'"'"'s body for positioning and/or manipulating the patch from a location outside the body. A support member may be arranged in or on the patch to help deploy the patch at the surgical site and/or help inhibit collapse or buckling of the patch.

Claims

1. An implantable prosthesis for repairing an abdominal wall defect, the implantable prosthesis comprising:

a multi-layer soft tissue repair patch including a first mesh layer, a second mesh layer and an adhesion resistant barrier layer, the first mesh layer located between the second mesh layer and the barrier layer; and

at least one tether extending from a side of the repair patch opposite the barrier layer, the tether including a mesh portion integrally formed with the second mesh layer, the tether having a sufficient length to extend from the patch and through the abdominal wall defect when the patch is on one side of the defect, so that a portion of the tether is accessible on the other side of the defect for manipulation from outside a patient'"'"'s body.

2. The implantable prosthesis of claim 1, further comprising a support member to support the repair patch in an unfolded configuration.

3. The implantable prosthesis of claim 2, wherein the support member is disposed on the repair patch.

4. The implantable prosthesis of claim 2, wherein the at least one tether extends from the patch inward of the support member.

5. The implantable prosthesis of claim 2, wherein the repair patch includes an outer peripheral edge, the support member being located inward of the outer peripheral edge.

6. The implantable prosthesis of claim 1, wherein the barrier layer is absorbable.

7. The implantable prosthesis of claim 1, wherein the first mesh layer is non-absorbable.

8. The implantable prosthesis of claim 1, wherein the at least one tether includes a pair of tethers integrally formed with the second mesh layer.

9. The implantable prosthesis of claim 8, wherein the second mesh layer includes an opening extending therethrough, the opening being located between the pair of tethers.

10. The implantable prosthesis of claim 9, wherein each tether is located along a side of the opening.

11. The implantable prosthesis of claim 8, wherein the tethers are joined to form a handle that may be grasped and pulled.

12. An implantable prosthesis for repairing an abdominal wall defect, the implantable prosthesis comprising:

a multi-layer soft tissue repair patch including a first mesh layer, a second mesh layer and an adhesion resistant barrier layer, the first mesh layer located between the second mesh layer and the barrier layer; and

at least one tether extending from a side of the repair patch opposite the barrier layer, the tether having a width and a thickness with the width varying along a length thereof, the tether having a sufficient length to extend from the patch and through the abdominal wall defect when the patch is on one side of the defect, so that a portion of the tether is accessible on the other side of the defect for manipulation from outside a patient'"'"'s body.

13. The implantable prosthesis of claim 12, wherein the tether includes first and second ends with the first end being joined to the repair patch, the tether being wider at the first end and narrower away from the first second end.

14. The implantable prosthesis of claim 12, further comprising a support member to support the repair patch in an unfolded configuration.

15. The implantable prosthesis of claim 14, wherein the support member is disposed on the repair patch.

16. The implantable prosthesis of claim 14, wherein the at least one tether extends from the patch inward of the support member.

17. The implantable prosthesis of claim 16, wherein the repair patch includes an outer peripheral edge, the support member located inward of the outer peripheral edge.

18. The implantable prosthesis of claim 12, wherein the barrier layer is absorbable.

19. The implantable prosthesis of claim 12, wherein the first mesh layer is non-absorbable.

20. The implantable prosthesis of claim 12, wherein the at least one tether includes a mesh material.

21. The implantable prosthesis of claim 20, wherein the at least one tether includes a portion of the second mesh layer.

22. The implantable prosthesis of claim 21, wherein the at least one tether includes a pair of tethers integrally formed with the second mesh layer.

23. The implantable prosthesis of claim 22, wherein the second mesh layer includes an opening extending therethrough, the opening being located between the pair of tethers.

24. The implantable prosthesis of claim 23, wherein each tether is located along a side of the opening.

25. The implantable prosthesis of claim 22, wherein the tethers are joined to form a handle that may be grasped and pulled.

26. The implantable prosthesis of claim 20, wherein the at least one tether includes a suture.

27. An implantable prosthesis for repairing an abdominal wall defect, the implantable prosthesis comprising:

a multi-layer soft tissue repair patch including a first mesh layer, a second mesh layer and an absorbable barrier layer, the first mesh layer located between the second mesh layer and the barrier layer;

a support member to support the repair patch in an unfolded configuration; and

a pair of tethers extending from a side of the repair patch opposite the barrier layer and inward of the support member, each tether including a portion of mesh material that forms the second mesh layer, the tether having a sufficient length to extend from the patch and through the abdominal wall defect when the patch is on one side of the defect, so that a portion of the tether is accessible on the other side of the defect for manipulation from outside a patient'"'"'s body.

28. The implantable prosthesis of claim 27, wherein the repair patch includes an outer peripheral edge, the support member being located inward of the outer peripheral edge.

29. The implantable prosthesis of claim 27, wherein the barrier layer minimizes tissue attachment to the patch.

30. The implantable prosthesis of claim 27, wherein the first mesh layer is non-absorbable.

31. The implantable prosthesis of claim 27, wherein the second mesh layer includes an opening extending therethrough, the opening being located between the pair of tethers.

32. The implantable prosthesis of claim 31, wherein each tether is located along a side of the opening.

33. The implantable prosthesis of claim 27, wherein the tethers are joined to form a handle that may be grasped and pulled.

34. The implantable prosthesis of claim 27, wherein the support member is disposed on the repair patch.

35. The implantable prosthesis of claim 27, wherein each tether includes a suture.

36. An implantable prosthesis for repairing an abdominal wall defect, the implantable prosthesis comprising:

a multi-layer soft tissue repair patch including a first mesh layer, a second mesh layer and an adhesion resistant barrier layer, the first mesh layer located between the second mesh layer and the barrier layer, the second mesh layer having an opening therethrough;

a support member to support the repair patch in an unfolded configuration; and

a pair of tethers extending from a side of the repair patch opposite the barrier layer and inward of the support member, the tethers extending from spaced apart portions of the repair patch with the opening located therebetween, each tether having a sufficient length to extend from the patch and through the abdominal wall defect when the patch is on one side of the defect, so that a portion of the tether is accessible on the other side of the defect for manipulation from outside a patient'"'"'s body.

37. The implantable prosthesis of claim 36, wherein the repair patch includes an outer peripheral edge, the support member being located inward of the outer peripheral edge.

38. The implantable prosthesis of claim 36, wherein the barrier layer is absorbable.

39. The implantable prosthesis of claim 36, wherein the first mesh layer is non-absorbable.

40. The implantable prosthesis of claim 36, wherein the opening extends across the width of the second layer.

41. The implantable prosthesis of claim 36, wherein each tether is located along a side of the opening.

42. The implantable prosthesis of claim 36, wherein the tethers are joined to form a handle that may be grasped and pulled.

43. The implantable prosthesis of claim 36, wherein each tether includes a mesh portion and a suture.

44. The implantable prosthesis of claim 36, wherein the support member is disposed on the repair patch.

45. An implantable prosthesis for repairing an abdominal wall defect, the implantable prosthesis comprising:

a multi-layer soft tissue repair patch including a first mesh layer, a second mesh layer and an adhesion resistant barrier layer, the first mesh layer located between the second mesh layer and the barrier layer; and

at least one tether extending from a side of the repair patch opposite the barrier layer, the tether including a mesh portion and a suture portion, the tether having a sufficient length to extend from the patch and through the abdominal wall defect when the patch is on one side of the defect, so that a portion of the tether is accessible on the other side of the defect for manipulation from outside a patient'"'"'s body.

46. The implantable prosthesis of claim 45, further comprising a support member to support the repair patch in an unfolded configuration.

47. The implantable prosthesis of claim 46, wherein the support member is disposed on the repair patch.

48. The implantable prosthesis of claim 46, wherein the at least one tether extends from the patch inward of the support member.

49. The implantable prosthesis of claim 48, wherein the repair patch includes an outer peripheral edge, the support member being located inward of the outer peripheral edge.

50. The implantable prosthesis of claim 46, wherein the support member is disposed on the repair patch.

51. The implantable prosthesis of claim 45, wherein the barrier layer is absorbable.

52. The implantable prosthesis of claim 45, wherein the first mesh layer is non-absorbable.

53. The implantable prosthesis of claim 45, wherein the at least one tether includes a pair of tethers.

54. The implantable prosthesis of claim 53, wherein the second mesh layer includes an opening extending therethrough, the opening being located between the pair of tethers.

55. The implantable prosthesis of claim 54, wherein each tether is located along a side of the opening.

56. The implantable prosthesis of claim 53, wherein the tethers are joined to form a handle that may be grasped and pulled.