Implantable prosthesis

• US 7,101,381 B2
• Filed: 08/02/2002
• Issued: 09/05/2006
• Est. Priority Date: 08/02/2002
• Status: Active Grant

• Current Assignee: Davol Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Torres, Donna Schulz, Ford, Steven Palmer
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US10/212,006
• Publication Number:
  US 20040087980A1
• Time in Patent Office: 1,495 Days
• Field of Search: 606/151, 600/29, 600/30, 600/37, 602/41, 602/44, 602/76, 602/67, 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 and/or plug having a body portion that is larger than a portion of the opening or weakness so that placement of the body portion against the defect will cover or extend across that portion of the opening or weakness. At least one tether, such as a strap, extends from the patch or plug and may be manipulated by a surgeon to position the patch or plug relative to the repair site and/or to secure the patch or plug 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 to allow a surgeon to position and/or manipulate the patch from a location outside the body. An indicator may be provided on the tether as an aid for a surgeon in determining when the patch or plug has been inserted a sufficient distance within the patient. A support member may be arranged in or on the patch or plug to help deploy the patch or plug at the surgical site and/or help inhibit collapse or buckling of the patch or plug. The patch or plug may be configured with a pocket or cavity to facilitate the deployment and/or positioning of the patch or plug over the opening or weakness.

Claims

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

a body portion of an implantable, biologically compatible material that is constructed and arranged to cover at least a portion of the tissue or muscle wall defect; and

first and second straps extending from the body portion, the first and second straps being constructed and arranged to extend through the tissue or muscle wall defect when the body portion is positioned over the defect, each of the first and second straps having a cross-section with a width and thickness, the width being greater than the thickness; and

in combination with

an overlay patch that has at least first and second strap openings adapted to slidably receive the first and second straps.

2. The prosthesis according to claim 1, wherein the first and second straps are susceptible to the formation of adhesions with tissue and organs.

3. The prosthesis according to claim 2, wherein each of the first and second straps has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

4. The prosthesis according to claim 3, wherein each of the first and second straps includes a layer of mesh fabric.

5. The prosthesis according to claim 3, further comprising an indicator disposed on at least one of the first and second straps at a predetermined location spaced from the body portion to indicate the position of the body portion relative to a reference location.

6. The prosthesis according to claim 5, wherein the indicator is preformed on the at least one of the first and second straps.

7. The prosthesis according to claim 5, wherein the indicator includes a contrasting colored thread.

8. The prosthesis according to claim 1, wherein the body portion includes a patch having at least one layer of repair fabric.

9. The prosthesis according to claim 8, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

10. The prosthesis according to claim 9, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

11. The prosthesis according to claim 9, 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 a surface of the at least one layer of repair fabric.

12. The prosthesis according to claim 11, further comprising an edge barrier that inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed on at least a portion of a periphery of the patch.

13. The prosthesis according to claim 8, further comprising a resilient support member disposed on the patch, the resilient support member being constructed and arranged to urge the patch into a planar configuration.

14. The prosthesis according to claim 8, wherein the first and second straps extend from a surface of the patch that is adapted to face the defect when the patch is positioned over the defect.

15. The prosthesis according to claim 14, wherein the first and second straps extend from the surface of the patch at first and second spaced apart junctions.

16. The implantable prosthesis according to claim 1, wherein the body portion includes an outer peripheral edge and an inner region within the outer peripheral edge, the first and second straps extending from the inner region.

17. An implantable prosthesis for repairing an existing or potential tissue or muscle wall defect, the implantable prosthesis comprising:

a patch of repair fabric that is constructed and arranged to cover at least a portion of the tissue or muscle wall defect, the patch including first and second layers of repair fabric that are joined to each other to create a pocket therebetween, the patch having an access opening that is adapted to provide entry into an interior of the pocket to facilitate positioning of the patch over the tissue or muscle wall defect, the access opening extending through one of the first and second layers; and

at least one tether extending from the patch and being constructed and arranged to extend through the tissue or muscle wall defect when the patch is positioned over the defect.

18. The prosthesis according to claim 17, wherein at least one of the first and second layers is susceptible to the formation of adhesions with tissue and organs.

19. The prosthesis according to claim 18, wherein the at least one of the first and second layers includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

20. The prosthesis according to claim 19, wherein the at least one of the first and second layers includes a mesh fabric.

21. The prosthesis according to claim 19, wherein each of the first and second layers includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

22. The prosthesis according to claim 21, wherein each of the first and second layers includes a mesh fabric.

23. The prosthesis according to claim 18, wherein each of the first and second layers is susceptible to the formation of adhesions with tissue and organs.

24. The prosthesis according to claim 18, 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 at least one of the first and second layers.

25. The prosthesis according to claim 24, further comprising an edge barrier that inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed on at least a portion of a periphery of the patch.

26. The prosthesis according to claim 17, further comprising a resilient support member disposed on the patch, the resilient support member being constructed and arranged to urge the patch into a planar configuration.

27. The prosthesis according to claim 26, wherein the resilient support member is disposed about at least a portion of the pocket between the first and second layers of repair fabric.

28. The prosthesis according to claim 27, wherein the resilient support member includes a resilient loop.

29. The prosthesis according to claim 17, wherein the at least one tether is susceptible to the formation of adhesions with tissue and organs.

30. The prosthesis according to claim 29, wherein the at least one tether has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

31. The prosthesis according to claim 30, wherein the at least one tether includes a layer of mesh fabric.

32. The prosthesis according to claim 17, wherein the at least one tether has a length that is sufficient to extend through the tissue or muscle wall defect and to be accessible from outside the patient when the body portion is positioned over the defect.

33. The prosthesis according to claim 17, wherein the at least one tether is configured as an elongated strap having a thickness and a width that is greater than the thickness.

34. The prosthesis according to claim 17, wherein the at least one tether includes first and second tethers extending from opposing sides of the access opening.

35. The prosthesis according to claim 34, wherein the access opening has a slit extending across at least a portion of one of the first and second layers.

36. The prosthesis according to claim 17, further comprising an indicator disposed on the at least one tether at a predetermined location spaced from the patch to indicate the position of the patch relative to a reference location.

37. The prosthesis according to claim 36, wherein the reference location is an end of a cannula, the predetermined location corresponding to a length of the cannula.

38. The prosthesis according to claim 36, wherein the predetermined location corresponds to a desired insertion depth of the body portion within a patient.

39. The prosthesis according to claim 36, wherein the indicator is preformed on the tether.

40. The prosthesis according to claim 36, wherein the indicator includes a contrasting colored thread.

41. The prosthesis according to claim 17, in combination with an overlay patch that has at least one tether opening adapted to slidably receive the at least one tether.

42. The implantable prosthesis according to claim 17, wherein the patch includes an outer peripheral edge and an inner region within the outer peripheral edge, the at least one tether extending from the inner region.

43. The prosthesis according to claim 17, wherein the at least one tether extends from a surface of the patch that is adapted to face the defect when the patch is positioned over the defect.

44. An implantable prosthesis for repairing an existing or potential tissue or muscle wall defect, the implantable prosthesis comprising:

at least one layer of repair fabric that is susceptible to the formation of adhesions with tissue and organs, the at least one layer of repair fabric being constructed and arranged to cover at least a portion of the tissue or muscle wall defect, the at least one layer of repair fabric having a first surface for facing the tissue or muscle wall defect and a second surface for facing away from the tissue or muscle wall defect;

a resilient support member disposed on the at least one layer of repair fabric, the resilient support member being constructed and arranged to urge the at least one layer of repair fabric into a planar configuration; and

first and second straps extending from the first surface of the at least one layer of repair fabric, the first and second straps having a length that is sufficient to extend through the tissue or muscle wall defect and outside the patient when the at least one layer of repair fabric is positioned over the defect, each of the first and second straps having a cross-section with a width and thickness, the width being greater than the thickness; and

in combination with

an overlay patch that has at least first and second strap openings adapted to slidably receive the first and second straps.

45. The prosthesis according to claim 44, wherein the length of each of the first and second straps is at least 2.5 inches.

46. The prosthesis according to claim 44, wherein each of the first and second straps is susceptible to the formation of adhesions with tissue and organs.

47. The prosthesis according to claim 46, wherein each of the first and second straps has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

48. The prosthesis according to claim 47, wherein each of the first and second straps includes a layer of mesh fabric.

49. The prosthesis according to claim 44, further comprising an indicator disposed on at least one of the first and second straps at a predetermined location spaced from the at least one layer of repair fabric to indicate the position of the at least one layer of repair fabric relative to a reference location.

50. The prosthesis according to claim 49, wherein the indicator is preformed on the at least one of the first and second straps.

51. The prosthesis according to claim 49, wherein the indicator includes a contrasting colored thread.

52. The prosthesis according to claim 44, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

53. The prosthesis according to claim 52, wherein the at least one layer of repair fabric includes a layer of mesh fabric.

54. The prosthesis according to claim 44, 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 a surface of the at least one layer of repair fabric.

55. The prosthesis according to claim 54, further comprising an edge barrier that inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed on at least a portion of a periphery of the at least one layer of repair fabric.

56. The prosthesis according to claim 44, wherein the at least one layer of repair fabric includes first and second layers that are joined to each other to create a pocket therebetween, at least one of the first and second layers having an access opening that is adapted to provide entry into an interior of the pocket to facilitate positioning of the first and second layers over the tissue or muscle wall defect.

57. The prosthesis according to claim 56, wherein the pocket has a periphery and the resilient support member includes a loop disposed along at least a portion of the periphery of the pocket between the first and second layers of repair fabric.

58. The prosthesis according to claim 56, wherein the access opening has a slit extending across a portion of the at least one of the first and second layers.

59. The prosthesis according to claim 56, wherein the first and second straps extend from the at least one of the first and second layers along opposite sides of the access opening.