Implantable prosthesis

• US 7,785,334 B2
• Filed: 08/23/2006
• Issued: 08/31/2010
• 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:
  US11/508,447
• Publication Number:
  US 20060282105A1
• Time in Patent Office: 1,469 Days
• Field of Search: 606/151, 600/29, 600/30, 600/37, 602/41, 602/44, 602/67, 602/70, 602/76, 128/95.1, 128/99.1, 623/23.72, 623/23.76
• 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 abdominal wall defect, the implantable prosthesis comprising:

a multi-layer patch including a first mesh layer, an absorbable barrier layer of oxidized regenerated cellulose, and a second mesh layer that allows for tissue ingrowth and that is located between the first mesh layer and the absorbable barrier layer of oxidized regenerated cellulose;

a support member located within the patch; and

a pair of anchoring straps extending away from the patch, each of the anchoring straps having a cross-section with a width and thickness, the width being greater than the thickness, each of the anchoring straps having a length sufficient, when the patch is on one side of the defect, to extend through the abdominal wall defect, so that a portion thereof is on the other side of the defect, and each of the anchoring straps adapted to be secured to anatomy by an attachment device that includes a suture, staple or tack so as to anchor the patch over the defect.

2. The prosthesis according to claim 1, wherein the second mesh layer is non-absorbable.

3. The prosthesis according to claim 2, wherein the second mesh layer is fabricated from polypropylene.

4. The prosthesis according to claim 1, wherein at least the first mesh layer is fabricated from polyglactin.

5. The prosthesis according to claim 1, wherein the patch includes a first surface that is to face the defect and a second surface that is to face away from the defect, the barrier layer being located at the second surface.

6. The prosthesis according to claim 5, wherein the pair of anchoring straps extend from the first surface of the patch at spaced apart locations.

7. The prosthesis according to claim 1, wherein the patch is configured to allow tissue ingrowth from the first surface into at least one of the first and second mesh layers.

8. The prosthesis according to claim 1, wherein each anchoring strap is adapted to be moved outwardly and in a direction towards the patch.

9. The prosthesis according to claim 8, wherein the pair of anchoring straps have a length of from approximately 2.5 inches to approximately 20 inches.

10. The prosthesis according to claim 8, wherein the anatomy is a margin of the defect.

11. The prosthesis according to claim 1, wherein each anchoring strap includes a layer of mesh fabric.

12. The prosthesis according to claim 1, wherein the support member includes a polymer ring.

13. The prosthesis according to claim 1, wherein the barrier layer resists tissue adhesions to the patch.

14. The prosthesis according to claim 1, wherein the barrier layer minimizes tissue attachment to the patch.

15. The prosthesis according to claim 1, wherein the barrier layer reduces tissue adhesions to the patch.

16. The prosthesis according to claim 1, wherein the support member aids in expansion of the patch.

17. The prosthesis according to claim 1, wherein the support member reinforces the patch.

18. The prosthesis according to claim 1, wherein the support member contributes to the stability of the patch.

19. The prosthesis according to claim 1, wherein the pair of anchoring straps are adapted to be manipulated by a user to selectively position the patch to cover an opening to the defect.

20. The prosthesis according to claim 1, wherein the pair of anchoring straps are adapted to secure the patch at the defect.

21. The prosthesis according to claim 1, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

22. The prosthesis according to claim 1, wherein the pair of anchoring straps are adapted to be pulled away from each other.

23. The prosthesis according to claim 1, wherein the pair of anchoring straps are adapted to lie flat relative to the patch.

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

a patch of repair fabric including an absorbable mesh layer, a non-absorbable mesh layer and a barrier layer;

a support member located between at least one of the mesh layers and the barrier layer; and

at least one anchoring strap extending away from the patch, the at least one anchoring strap having a cross-section with a width and thickness, the width being greater than the thickness, the at least one anchoring strap having a length sufficient, when the patch is on one side of the defect, to extend through the abdominal wall defect, so that a portion thereof is on the other side of the defect, the at least one anchoring strap adapted to be secured to anatomy by an attachment device that includes a suture, staple or tack so as to anchor the patch over the defect.

25. The prosthesis according to claim 24, wherein the non-absorbable mesh layer is located between the absorbable mesh layer and the barrier layer.

26. The prosthesis according to claim 25, wherein the non-absorbable mesh layer is fabricated from polypropylene.

27. The prosthesis according to claim 26, wherein the absorbable mesh layer is fabricated from polyglactin.

28. The prosthesis according to claim 24, wherein the barrier layer includes an absorbable material.

29. The prosthesis according to claim 28, wherein the absorbable material includes oxidized regenerated cellulose.

30. The prosthesis according to claim 24, wherein the patch is configured to allow tissue ingrowth from the first surface into at least one of the mesh layers.

31. The prosthesis according to claim 24, wherein the at least one anchoring strap includes a pair of anchoring straps.

32. The prosthesis according to claim 24, wherein the patch includes a first surface that is to face the defect and a second surface that is to face away from the defect, the barrier layer being located at the second surface.

33. The prosthesis according to claim 32, wherein the at least one anchoring strap includes a pair of anchoring straps that extend from the first surface of the patch at spaced apart locations.

34. The prosthesis according to claim 33, wherein the pair of anchoring straps are adapted to be pulled away from each other.

35. The prosthesis according to claim 24, wherein the at least one anchoring strap is adapted to be moved outwardly and in a direction towards the patch.

36. The prosthesis according to claim 35, wherein the at least one anchoring strap has a length of from approximately 2.5 inches to approximately 20 inches.

37. The prosthesis according to claim 35, wherein the anatomy is a margin of the defect.

38. The prosthesis according to claim 24, wherein the at least one anchoring strap includes a layer of mesh fabric.

39. The prosthesis according to claim 24, wherein the support member includes a polymer ring.

40. The prosthesis according to claim 24, wherein the barrier layer resists tissue adhesions to the patch.

41. The prosthesis according to claim 24, wherein the barrier layer minimizes tissue attachment to the patch.

42. The prosthesis according to claim 24, wherein the barrier layer reduces tissue adhesions to the patch.

43. The prosthesis according to claim 24, wherein the support member aids in expansion of the patch.

44. The prosthesis according to claim 24, wherein the support member reinforces the patch.

45. The prosthesis according to claim 24, wherein the support member contributes to the stability of the patch.

46. The prosthesis according to claim 24, wherein the at least one anchoring strap is adapted to be manipulated by a user to selectively position the patch to cover an opening to the defect.

47. The prosthesis according to claim 24, wherein the at least one anchoring strap is adapted to secure the patch at the defect.

48. The prosthesis according to claim 24, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

49. The prosthesis according to claim 24, wherein the at least one anchoring strap is adapted to lie flat relative to the patch.

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

a patch of repair fabric including at least one mesh layer and a barrier layer;

a support ring located between the at least one mesh layer and the barrier layer; and

at least one positioning strap extending away from the patch and having a cross-section with a width and thickness, the width being greater than the thickness, the at least one positioning strap having a length sufficient, when the patch is on one side of the defect, to extend through the abdominal wall defect, so that a portion thereof is on the other side of the defect is adapted to be manipulated to position the patch relative to the defect, and is adapted for attachment to tissue with an attachment device.

51. The prosthesis according to claim 50, wherein the patch includes absorbable and non-absorbable materials.

52. The prosthesis according to claim 50, wherein the at least one mesh layer includes first and second mesh layers, the second mesh layer being located between the first mesh layer and the barrier layer.

53. The prosthesis according to claim 52, wherein at least the second mesh layer includes a non-absorbable material.

54. The prosthesis according to claim 53, wherein the second mesh layer is fabricated from polypropylene.

55. The prosthesis according to claim 52, wherein at least the first mesh layer includes an absorbable material.

56. The prosthesis according to claim 55, wherein the first mesh layer is fabricated from polyglactin.

57. The prosthesis according to claim 50, wherein the barrier layer includes an absorbable material.

58. The prosthesis according to claim 57, wherein the barrier layer is fabricated from oxidized regenerated cellulose.

59. The prosthesis according to claim 50, wherein the patch includes a first surface that is to face the defect and a second surface that is to face away from the defect, the barrier layer being located at the second surface.

60. The prosthesis according to claim 59, wherein the patch is configured to allow tissue ingrowth from the first surface into the at least one mesh layer.

61. The prosthesis according to claim 59, wherein the at least one positioning strap includes a pair of positioning straps that extend from the first surface of the patch at spaced apart locations.

62. The prosthesis according to claim 50, wherein the at least one positioning strap includes a pair of positioning straps.

63. The prosthesis according to claim 62, wherein the pair of positioning straps are adapted to be pulled away from each other.

64. The prosthesis according to claim 50, wherein the portion of the at least one positioning strap is adapted to be pulled by a user to selectively position the patch to cover an opening to the defect.

65. The prosthesis according to claim 64, wherein the at least one positioning strap has a length of from approximately 2.5 inches to approximately 20 inches.

66. The prosthesis according to claim 50, wherein the at least one positioning strap includes a layer of mesh fabric.

67. The prosthesis according to claim 50, wherein the support ring includes a polymer ring.

68. The prosthesis according to claim 50, wherein the barrier layer resists tissue adhesions to the patch.

69. The prosthesis according to claim 50, wherein the barrier layer minimizes tissue attachment to the patch.

70. The prosthesis according to claim 50, wherein the barrier layer reduces tissue adhesions to the patch.

71. The prosthesis according to claim 50, wherein the support ring reinforces the patch.

72. The prosthesis according to claim 50, wherein the support ring contributes to the stability of the patch.

73. The prosthesis according to claim 50, wherein the support ring aids in expansion of the patch.

74. The prosthesis according to claim 50, wherein the attachment device includes a suture, staple or tack.

75. The prosthesis according to claim 74, wherein the anatomy is a margin of the defect.

76. The prosthesis according to claim 50, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

77. The prosthesis according to claim 50, wherein the at least one positioning strap is adapted to lie flat relative to the patch.

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

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

a ring-shaped support member located between the first mesh layer and the barrier layer; and

a pair of positioning straps extending away from the patch, each strap having a cross-section with a width and thickness, the width being greater than the thickness, each strap having a length sufficient, when the patch is on one side of the defect, to extend through the abdominal wall defect, so that a portion thereof is on the other side of the defect is adapted to be manipulated to position the patch relative to the defect, and is adapted to be attached to tissue with an attachment device.

79. The prosthesis according to claim 78, wherein the second mesh layer is non-absorbable.

80. The prosthesis according to claim 79, wherein the second mesh layer is fabricated from polypropylene.

81. The prosthesis according to claim 78, wherein the patch includes a first surface that is to face the defect and a second surface that is to face away from the defect, the barrier layer being located at the second surface.

82. The prosthesis according to claim 81, wherein the pair of positioning straps extend from the first surface of the patch at spaced apart locations.

83. The prosthesis according to claim 78, wherein the patch is configured to allow tissue ingrowth from the first surface into at least one of the first and second mesh layers.

84. The prosthesis according to claim 78, wherein the portion of the pair of positioning straps are adapted to be manipulated by a user to selectively position the patch to cover an opening to the defect.

85. The prosthesis according to claim 84, wherein each positioning strap has a length of from approximately 2.5 inches to approximately 20 inches.

86. The prosthesis according to claim 78, wherein the pair of positioning straps are adapted to secure the patch at the defect.

87. The prosthesis according to claim 78, wherein each positioning strap includes a layer of mesh fabric.

88. The prosthesis according to claim 78, wherein at least the first mesh layer includes an absorbable material.

89. The prosthesis according to claim 78, wherein the barrier layer resists tissue attachment to the patch.

90. The prosthesis according to claim 78, wherein the barrier layer resists tissue adhesions to the patch.

91. The prosthesis according to claim 78, wherein the barrier layer minimizes tissue attachment to the patch.

92. The prosthesis according to claim 78, wherein the barrier layer reduces adhesions to the patch.

93. The prosthesis according to claim 78, wherein the support member reinforces the patch.

94. The prosthesis according to claim 78, wherein the support member contributes to the stability of the patch.

95. The prosthesis according to claim 78, wherein the support member aids in expansion of the patch.

96. The prosthesis according to claim 78, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

97. The prosthesis according to claim 78, wherein the pair of positioning straps are adapted to be pulled away from each other.

98. The prosthesis according to claim 78, wherein the pair of positioning straps are adapted to lie flat relative to the patch.

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

a patch of biologically compatible material including a first layer and a second layer;

a support member located between the first and second layers; and

at least one tether including a strap portion extending away from the patch, the strap portion having a cross-section with a width and thickness, the width being greater than the thickness, the tether having a length sufficient, when the patch is on one side of the defect, to extend through the abdominal wall defect, so that a portion of the tether is on the other side of the defect and is adapted to be attached to tissue with an attachment device.

100. The prosthesis according to claim 99, wherein at least one of the first and second layers includes a mesh fabric.

101. The prosthesis according to claim 99, wherein the patch includes absorbable and non-absorbable materials.

102. The prosthesis according to claim 101, wherein at least one of the first and second layers includes a barrier layer.

103. The prosthesis according to claim 102, wherein at least one of the first and second layers includes a non-absorbable material.

104. The prosthesis according to claim 102, wherein at least one of the first and second layers includes an absorbable material.

105. The prosthesis according to claim 102, wherein the barrier layer includes an absorbable material.

106. The prosthesis according to claim 102, wherein the barrier layer resists tissue adhesions to the patch.

107. The prosthesis according to claim 102, wherein the barrier layer minimizes tissue attachment to the patch.

108. The prosthesis according to claim 102, wherein the barrier layer reduces adhesions to the patch.

109. The prosthesis according to claim 102, wherein the patch includes a first surface that is to face the defect and a second surface that is to face away from the defect, the barrier layer being located at the second surface.

110. The prosthesis according to claim 109, wherein the patch is configured to allow tissue ingrowth from the first surface into at least one of the first and second layers.

111. The prosthesis according to claim 109, wherein the at least one tether includes a pair of strap portions.

112. The prosthesis according to claim 99, wherein the at least one tether includes a pair of strap portions.

113. The prosthesis according to claim 112, wherein the pair of strap portions are adapted to be pulled away from each other.

114. The prosthesis according to claim 99, wherein the attachment device includes a suture, staple or tack, for anchoring the patch over the defect.

115. The prosthesis according to claim 114, wherein the at least one tether has a length of from approximately 2.5 inches to approximately 20 inches.

116. The prosthesis according to claim 114, wherein the anatomy is a margin of the defect.

117. The prosthesis according to claim 99, wherein the at least one tether is adapted to be manipulated by a user to selectively position the patch to cover an opening to the defect.

118. The prosthesis according to claim 117, wherein the strap portion of the at least one tether is adapted to secure the patch at the defect.

119. The prosthesis according to claim 99, wherein the strap portion of the at least one tether is adapted to secure the patch at the defect.

120. The prosthesis according to claim 99, wherein the at least one tether includes a layer of mesh fabric.

121. The prosthesis according to claim 99, wherein the support member is ring-shaped.

122. The prosthesis according to claim 99, wherein the support member reinforces the patch.

123. The prosthesis according to claim 99, wherein the support member contributes to the stability of the patch.

124. The prosthesis according to claim 99, wherein the support member aids in expansion of the patch.

125. The prosthesis according to claim 99, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

126. The prosthesis according to claim 99, wherein the strap portion is adapted to lie flat relative to the patch.