Prosthetic repair fabric

• US 7,011,688 B2
• Filed: 05/10/2002
• Issued: 03/14/2006
• Est. Priority Date: 05/10/2002
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Darois, Roger E., Eldridge, Stephen N., Lee, Michael J., Vadurro, Valerie, Gryska, Paul vonRyll
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Prone, Christopher D.
• Application Number:
  US10/143,743
• Publication Number:
  US 20030212462A1
• Time in Patent Office: 1,404 Days
• Field of Search: 606/151, 600/37, 623/11.11, 623/23.72
• US Class Current: 623/23.72
• 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 includes a repair fabric with a generally triangular-shaped body and two tails extending outward from the base of the triangular body. The tails may be rounded to provide the repair fabric with a generally heart-shaped configuration. An opening is provided along the base of the body and between the two tails for receiving a tube-like structure, such as the esophagus. The prosthesis may include a layer of 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 edge barrier that is attached to the tails and overlies a portion of the opening. A portion of the edge barrier may be folded into the opening to isolate the tube-like structure from an edge of the opening.

Claims

1. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of an esophagus, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric having an opening that is adapted to receive the esophagus, the repair fabric being susceptible to the formation of adhesions with and erosion into tissue and organs and 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, the repair fabric including a body portion and first and second tails extending away from the body portion, the body portion being configured in a generally triangular shape with a base having first and second segments, the first tail extending from the first segment of the base and the second tail extending from the second segment of the base, the opening being located along the base between the first and second tails; and

an edge barrier that is adapted to inhibit the formation of adhesions with at least a portion of the fabric edge, the edge barrier being disposed on a portion of the first surface of the repair fabric proximate the opening, the edge barrier extending beyond the base to overlie a portion of the opening between the first and second tails, the edge barrier including an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first tail to the second tail, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion, the edge barrier including a curved outer edge that extends across the opening from the first tail to the second tail, the outer edge overlying the first tail at a first support point and the second tail at a second support point, the fold line extending from the first support point to the second support point.

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

3. The implantable prosthesis according to claim 1, wherein repair fabric is formed from one of a PTFE mesh and a polypropylene mesh.

4. The implantable prosthesis according to claim 1, wherein the repair fabric includes a first surface and a 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, the implantable prosthesis 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.

5. The implantable prosthesis according to claim 4, wherein the surface barrier is disposed on substantially the entire second surface of the repair fabric.

6. The implantable prosthesis according to claim 4, wherein the surface barrier is formed from ePTFE.

7. The implantable prosthesis according to claim 1, wherein the edge barrier has a tear drop-shaped configuration.

11. The implantable prosthesis according to claim 1, wherein the edge barrier is disposed about at least a portion the fabric edge of one of the first and second tails.

12. The implantable prosthesis according to claim 11, wherein the edge barrier is disposed about at least a portion of the fabric edge of each of the first and second tails.

13. The implantable prosthesis according to claim 1, wherein the edge barrier is disposed about the fabric edge of at least a portion of the opening.

14. The implantable prosthesis according to claim 1, wherein a portion of each of the first and second tails has a rounded periphery.

15. The implantable prosthesis according to claim 1, wherein each of the first and second tails includes an outer end that is spaced from the base, each of the first and second tails having a width that decreases in a direction from the base toward the outer end.

16. The implantable prosthesis according to claim 1, wherein the repair fabric includes first and second layers that are joined to each other along an inverted seam that extends inwardly between the first and second layers to inhibit erosion of the tissue and organs.

17. The implantable prosthesis according to claim 1, wherein the repair fabric has a heart-shaped configuration.

8. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of an esophagus, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric having an opening that is adapted to receive the esophagus, the repair fabric being susceptible to the formation of adhesions with and erosion into tissue and organs and 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, the repair fabric including a body portion and first and second tails extending away from the body portion, the body portion being configured in a generally triangular shape with a base having first and second segments, the first tail extending from the first segment of the base and the second tail extending from the second segment of the base, the opening being located along the base between the first and second tails; and

an edge barrier that is adapted to inhibit the formation of adhesions with at least a portion of the fabric edge, the edge barrier being disposed on a portion of the first surface of the repair fabric proximate the opening, the edge barrier extending beyond the base to overlie a portion of the opening between the first and second tails, the edge barrier including an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first tail to the second tail, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion, the edge barrier including a curved outer edge that extends across the opening from the first tail to the second tail, the outer edge overlying the first tail at a first support point and the second tail at a second support point, the edge barrier being attached to the first and second tails at first and second attachments points, respectively, the first and second attachment points being located between the first and second support points and the base.

9. The implantable prosthesis according to claim 8, wherein the fold line extends from the first attachment point to the second attachment point.

10. The implantable prosthesis according to claim 8, wherein the fold line extends from a region of the first tail extending from the first support point to the first attachment point to a region of the second tail extending from the second support point to the second attachment point.

18. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of a tube-like structure, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric having a generally heart shaped outer periphery with a pair of rounded lobes and an opening along a portion of the outer periphery that is adapted to receive the tube-like structure.

19. The implantable prosthesis according to claim 18, wherein the repair fabric is susceptible to the formation of adhesions with and erosion into tissue and organs.

20. The implantable prosthesis according to claim 19, wherein the repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

21. The implantable prosthesis according to claim 19, wherein repair fabric is formed from one of a PTFE mesh and a polypropylene mesh.

22. The implantable prosthesis according to claim 19, wherein the repair fabric includes a first surface and a 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, the implantable prosthesis 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.

23. The implantable prosthesis according to claim 22, wherein the surface barrier is disposed on substantially the entire second surface of the repair fabric.

24. The implantable prosthesis according to claim 22, wherein the surface barrier is formed from ePTFE.

25. The implantable prosthesis according to claim 18, wherein the repair fabric includes 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, the implantable prosthesis further comprising an edge barrier that inhibits the formation of adhesions with at least a portion of the fabric edge.

26. The implantable prosthesis according to claim 25, wherein the repair fabric includes a body portion and first and second lobes extending from the body portion with the opening being located between the first and second lobes, the edge barrier being disposed on a portion of the first surface of the repair fabric proximate the opening, the edge barrier extending beyond the body portion to overlie a portion of the opening between the first and second lobes.

27. The implantable prosthesis according to claim 26, wherein the edge barrier includes an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first lobe to the second lobe, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion.

28. The implantable prosthesis according to claim 27, wherein the edge barrier includes a curved outer edge that extends across the opening from the first lobe to the second lobe, the outer edge overlying the first lobe at a first support point and the second lobe at a second support point.

29. The implantable prosthesis according to claim 28, wherein the edge barrier has a tear drop-shaped configuration.

30. The implantable prosthesis according to claim 28, wherein the fold line extends from the first support point to the second support point.

31. The implantable prosthesis according to claim 28, wherein the edge barrier is attached to the first and second lobes at first and second attachments points, respectively, the first and second attachment points being located between the first and second support points and the body portion.

32. The implantable prosthesis according to claim 31, wherein the fold line extends from the first attachment point to the second attachment point.

33. The implantable prosthesis according to claim 31, wherein the fold line extends from a region of the first lobe extending from the first support point to the first attachment point to a region of the second lobe extending from the second support point to the second attachment point.

34. The implantable prosthesis according to claim 25, wherein the edge barrier is disposed about at least a portion of the fabric edge of one of the first and second lobe.

35. The implantable prosthesis according to claim 34, wherein the edge barrier is disposed about at least a portion of the fabric edge of each of the first and second lobes.

36. The implantable prosthesis according to claim 25, wherein the edge barrier is disposed about at least a portion of the fabric edge of the opening.

37. The implantable prosthesis according to claim 18, wherein the repair fabric includes first and second layers that are joined to each other along an inverted seam that extends inwardly between the first and second layers to inhibit erosion of the tissue and organs.

38. The implantable prosthesis according to claim 18, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.

39. A prosthetic repair fabric for repairing a tissue or muscle wall defect in the vicinity of a tube-like structure, the prosthetic repair fabric comprising:

a layer of fabric that is susceptible to the formation of adhesions with and erosion into tissue and organs, the layer of fabric having an opening adapted to receive the tube-like structure, the repair fabric including a body portion and first and second tails extending away from the body portion, the opening being located along an edge of the body between the first and second tails; and

an edge barrier that is adapted to inhibit the formation of adhesions of tissue and organs with the edge of the body between the first and second tails, the edge barrier being attached to the first tail at a first attachment point and to the second tail at a second attachment point, the first and second attachment points being aligned with each other across a segment of the opening, a portion of the edge barrier overlying a portion of the opening and extending between the first and second attachment points,

the edge barrier including an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first tail to the second tail, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion.

40. The implantable prosthesis according to claim 39, wherein the edge barrier includes a curved outer edge that extends across the opening from the first tail to the second tail, the outer edge overlying the first tail at a first support point and the second tail at a second support point.

41. The implantable prosthesis according to claim 40, wherein the edge barrier has a tear drop-shaped configuration.

42. The implantable prosthesis according to claim 40, wherein the fold line extends from the first support point to the second support point.

43. The implantable prosthesis according to claim 40, wherein the first and second attachment points are located between the first and second support points and the body portion.

44. The implantable prosthesis according to claim 43, wherein the fold line extends from the first attachment point to the second attachment point.

45. The implantable prosthesis according to claim 43, wherein the fold line extends from a region of the first tail extending from the first support point to the first attachment point to a region of the second tail extending from the second support point to the second attachment point.

46. The implantable prosthesis according to claim 39, wherein the repair fabric is susceptible to the formation of adhesions with and erosion into tissue and organs.

47. The implantable prosthesis according to claim 46, wherein the repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

48. The implantable prosthesis according to claim 46, wherein repair fabric is formed from one of a PTFE mesh and a polypropylene mesh.

49. The implantable prosthesis according to claim 46, wherein the repair fabric includes a first surface and a 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, the implantable prosthesis 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.

50. The implantable prosthesis according to claim 49, wherein the surface barrier is disposed on substantially the entire second surface of the repair fabric.

51. The implantable prosthesis according to claim 49, wherein the surface barrier is formed from ePTFE.

52. The implantable prosthesis according to claim 39, wherein each of the first and second tails has a rounded periphery.

53. The implantable prosthesis according to claim 39, wherein the repair fabric includes first and second layers that are joined to each other along an inverted seam that extends inwardly between the first and second layers to inhibit erosion of the tissue and organs.

54. The implantable prosthesis according to claim 39, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.

55. The implantable prosthesis according to claim 39, wherein the repair fabric has a heart-shaped configuration.

56. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of a tube-like structure, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric being susceptible to the formation of adhesions with and erosion into tissue and organs and 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, the repair fabric having an opening that is adapted to receive the tube-like structure, the repair fabric including a body portion and first and second tails extending away from the body portion, the body portion being configured in a generally triangular shape with a base having first and second segments, the first tail has a first outer edge that is opposite to and spaced from the first segment of the base and the second tail has a second outer edge that is opposite to and spaced from the second segment of the base, the opening being located along the base between the first and second tails and having a width that does not decrease as the first and second tails extend away from the base to the first and second outer edges; and

an edge barrier that is adapted to inhibit the formation of adhesions with at least a portion of the fabric edge, the edge barrier being disposed on a portion of the first surface of the repair fabric proximate the opening, the edge barrier extending beyond the base to overlie a portion of the opening between the first and second tails, the edge barrier including an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first tail to the second tail, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion.

57. The implantable prosthesis according to claim 56, wherein each of the first and second tails has a periphery with a rounded shape.

58. The implantable prosthesis according to claim 56, wherein the repair fabric is symmetrical about an axis extending from the vertex to a midpoint of the base between the first and second tails.

59. The implantable prosthesis according to claim 56, wherein the repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

60. The implantable prosthesis according to claim 56, wherein the repair fabric is formed from one of a PTFE mesh and a polypropylene mesh.

61. The implantable prosthesis according to claim 56, wherein the repair fabric includes a first surface and a 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, the implantable prosthesis 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.

62. The implantable prosthesis according to claim 61, wherein the surface barrier is formed from ePTFE.

63. The implantable prosthesis according to claim 56, wherein the edge barrier includes a curved outer edge that extends across the opening from the first tail to the second tail, the outer edge overlying the first tail at a first support point and the second tail at a second support point.

64. The implantable prosthesis according to claim 63, wherein the edge barrier is attached to the first and second tails at first and second attachments points, respectively, the first and second attachment points being located between the first and second support points and the base.

65. The implantable prosthesis according to claim 56, wherein each of the first and second tails has a width that decreases in a direction from the base toward the first and second outer edges respectively.

67. The implantable prosthesis according to claim 56, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.

66. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of a tube-like structure, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric including first and second layers that are joined to each other along an inverted seam that extends inwardly between the first and second layers to inhibit erosion of the tissue and organs, the repair fabric having an opening that is adapted to receive the tube-like structure, the repair fabric including a body portion and first and second tails extending away from the body portion, the body portion being configured in a generally triangular shape with a base having first and second segments, the first tail has a first outer edge that is opposite to and spaced from the first segment of the base and the second tail has a second outer edge that is opposite to and spaced from the second segment of the base, the opening being located along the base between the first and second tails and having a width that does not decrease as the first and second tails extend away from the base to the first and second outer edges.

68. An implantable prosthesis for repairing a tissue or muscle wall defect in the vicinity of a tube-like structure, the implantable prosthesis comprising:

a repair fabric of implantable, biologically compatible material, the repair fabric having an opening that is adapted to receive the tube-like structure, the repair fabric including a body portion and first and second tails extending away from the body portion, the body portion being configured in a generally triangular shape with a base having first and second segments, the first tail has a first outer edge that is opposite to and spaced from a first segment of the base and the second tail has a second outer edge that is opposite to and spaced from a second segment of the base, the opening being located along the base between the first and second tails, each of the first and second tails having an outer periphery that extends from the first and second outer edges, respectively, toward the opening, the outer periphery being configured with a convex curve.

69. The implantable prosthesis according to claim 68, wherein the repair fabric is symmetrical about an axis extending from a vertex of the body portion to a midpoint of the base between the first and second tails.

70. The implantable prosthesis according to claim 68, wherein the repair fabric is susceptible to the formation of adhesions with and erosion into tissue and organs.

71. The implantable prosthesis according to claim 70, wherein the repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

72. The implantable prosthesis according to claim 70, wherein the repair fabric is formed from one of a PTFE mesh and a polypropylene mesh.

73. The implantable prosthesis according to claim 70, wherein the repair fabric includes a first surface and a 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, the implantable prosthesis 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.

74. The implantable prosthesis according to claim 73, wherein the surface barrier is formed from ePTFE.

75. The implantable prosthesis according to claim 70, wherein the repair fabric includes 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, the implantable prosthesis further comprising an edge barrier that is adapted to inhibit the formation of adhesions with at least a portion of the fabric edge.

76. The implantable prosthesis according to claim 75, wherein the edge barrier is disposed on a portion of the first surface of the repair fabric proximate the opening, the edge barrier extending beyond the base to overlie a portion of the opening between the first and second tails.

77. The implantable prosthesis according to claim 76, wherein the edge barrier includes an outer portion that is adapted to fold into the opening along a fold line that extends across the opening from the first tail to the second tail, the edge barrier further including a ledge portion that overlies the opening between the fold line and the body portion.

78. The implantable prosthesis according to claim 68, wherein each of the first and second tails has a width that decreases in a direction from the base toward the first and second outer edges respectively.

79. The implantable prosthesis according to claim 68, wherein the repair fabric includes first and second layers that are joined to each other along an inverted seam that extends inwardly between the first and second layers to inhibit erosion of the tissue and organs.

80. The implantable prosthesis according to claim 68, wherein the repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.