Implantable prosthesis

• US 20040087980A1
• Filed: 08/02/2002
• Published: 05/06/2004
• 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
• Granted Patent: US 7,101,381 B2
• Time in Patent Office: Days
• 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 in a patient, the implantable prosthesis comprising:

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

at least one tether extending from the body portion and having a cross-section with a width and thickness, the width being greater than the thickness, the at least one tether having 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, the length of the at least one tether being at least 2.5 inches.

2. The prosthesis according to claim 1, wherein the length of the at least one tether is at least 4 inches.

3. The prosthesis according to claim 1, wherein the length of the at least one tether is at least 7 inches.

4. The prosthesis according to claim 1, wherein the length of the at least one tether is approximately 9 inches.

5. The prosthesis according to claim 1, wherein the length of the at least one tether is at least 10 inches.

6. The prosthesis according to claim 1, wherein the length of the at least one tether is at least 12 inches.

7. The prosthesis according to claim 1, wherein the length of the at least one tether is approximately 15 inches.

8. The prosthesis according to claim 1, wherein the at least one tether includes first and second tethers.

9. The prosthesis according to claim 1, wherein the at least one tether is susceptible to the formation of adhesions with tissue and organs.

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

11. The prosthesis according to claim 10, wherein the at least one tether includes a layer of mesh fabric.

12. The prosthesis according to claim 1, further comprising an indicator disposed on the at least one tether at a predetermined location to indicate the position of the body portion relative to a reference location.

13. The prosthesis according to claim 12, wherein the indicator is preformed on the at least one tether.

14. The prosthesis according to claim 12, wherein the indicator includes a contrasting colored thread.

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

16. The prosthesis according to claim 15, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

17. The prosthesis according to claim 16, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

18. The prosthesis according to claim 16, 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.

19. The prosthesis according to claim 18, 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.

20. The prosthesis according to claim 15, 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.

21. The prosthesis according to claim 15, 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.

22. The prosthesis according to claim 1, in combination with an overlay patch that has at least one tether opening adapted to slidably receive the at least one tether.

23. 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.

24. The prosthesis according to claim 23, wherein the first and second straps are susceptible to the formation of adhesions with tissue and organs.

25. The prosthesis according to claim 24, wherein each of the first and second straps has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

26. The prosthesis according to claim 25, wherein each of the first and second straps includes a layer of mesh fabric.

27. The prosthesis according to claim 23, further comprising an indicator disposed on at least one of the first and second straps at a predetermined location to indicate the position of the body portion relative to a reference location.

28. The prosthesis according to claim 27, wherein the indicator is preformed on the at least one of the first and second straps.

29. The prosthesis according to claim 27, wherein the indicator includes a contrasting colored thread.

30. The prosthesis according to claim 23, wherein the body portion includes a patch having at least one layer of repair fabric.

31. The prosthesis according to claim 30, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

32. The prosthesis according to claim 31, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

33. The prosthesis according to claim 31, 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.

34. The prosthesis according to claim 33, 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.

35. The prosthesis according to claim 30, 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.

36. The prosthesis according to claim 30, 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.

37. The prosthesis according to claim 36, wherein the first and second straps extend from the surface of the patch at first and second spaced apart junctions.

38. The prosthesis according to claim 23, in combination with an overlay patch that has at least first and second strap openings adapted to slidably receive the first and second straps.

39. 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;

a resilient support member disposed on the patch to urge the patch to a planar configuration; and

at least one tether of repair fabric that is susceptible to tissue and muscle integration, the 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.

40. The prosthesis according to claim 39, wherein the at least one tether has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

41. The prosthesis according to claim 40, wherein the at least one tether includes a layer of mesh fabric.

42. The prosthesis according to claim 41, wherein the at least one tether includes first and second tethers.

43. The prosthesis according to claim 39, wherein the at least one tether has a strap configuration with a thickness and a width that is greater than the thickness.

44. The prosthesis according to claim 39, further comprising an indicator disposed on the at least one tether at a predetermined location to indicate the position of the body portion relative to a reference location.

45. The prosthesis according to claim 44, wherein the indicator is preformed on the at least one tether.

46. The prosthesis according to claim 44, wherein the indicator includes a contrasting colored thread.

47. The prosthesis according to claim 39, wherein the patch includes at least one layer of repair fabric.

48. The prosthesis according to claim 47, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

49. The prosthesis according to claim 48, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

50. The prosthesis according to claim 48, 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.

51. The prosthesis according to claim 50, 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.

52. The prosthesis according to claim 39, wherein the patch includes a periphery, the resilient support member including a loop that extends about a portion of the patch proximate the periphery.

53. The prosthesis according to claim 39, wherein the loop includes a monofilament that is supported on the patch.

54. The prosthesis according to claim 39, in combination with an overlay patch that has at least one tether opening adapted to slidably receive the at least one tether.

55. 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;

a resilient support member disposed on the patch, the resilient support member being constructed and arranged to urge the patch into a planar configuration; and

at least one strap extending from the patch, the at least one strap being constructed and arranged to extend through the tissue or muscle wall defect when the patch is positioned over the defect, the at least one strap having a cross-section with a width and thickness, the width being greater than the thickness.

56. The prosthesis according to claim 55, wherein the at least one strap is susceptible to tissue and muscle integration.

57. The prosthesis according to claim 56, wherein the at least one strap has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

58. The prosthesis according to claim 57, wherein the at least one strap includes a layer of mesh fabric.

59. The prosthesis according to claim 58, wherein the at least one strap includes first and second straps.

60. The prosthesis according to claim 55, further comprising an indicator disposed on the at least one strap at a predetermined location to indicate the position of the body portion relative to a reference location.

61. The prosthesis according to claim 60, wherein the indicator is preformed on the at least one strap.

62. The prosthesis according to claim 60, wherein the indicator includes a contrasting colored thread.

63. The prosthesis according to claim 55, wherein the patch includes at least one layer of repair fabric.

64. The prosthesis according to claim 63, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

65. The prosthesis according to claim 64, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

66. The prosthesis according to claim 64, 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.

67. The prosthesis according to claim 66, 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.

68. The prosthesis according to claim 55, wherein the patch includes a periphery, the resilient support member including a loop that extends about a portion of the patch proximate the periphery.

69. The prosthesis according to claim 55, wherein the loop includes a monofilament that is supported on the patch.

70. The prosthesis according to claim 55, in combination with an overlay patch that has at least one strap opening adapted to slidably receive the at least one strap.

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

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

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

an indicator disposed on the at least one tether at a predetermined location to indicate a position of the body portion relative to a reference location.

72. The prosthesis according to claim 71, wherein the reference location is an end of a cannula, the predetermined location corresponding to a length of the cannula.

73. The prosthesis according to claim 71, wherein the predetermined location corresponds to a desired insertion depth of the body portion within a patient.

74. The prosthesis according to claim 71, wherein the indicator is preformed on the tether.

75. The prosthesis according to claim 71, wherein the indicator includes a contrasting colored thread.

76. The prosthesis according to claim 71, 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.

77. The prosthesis according to claim 76, wherein the at least one tether includes first and second tethers.

78. The prosthesis according to claim 71, wherein the at least one tether is susceptible to the formation of adhesions with tissue and organs.

79. The prosthesis according to claim 78, wherein the at least one tether has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

80. The prosthesis according to claim 79, wherein the at least one tether includes a layer of mesh fabric.

81. The prosthesis according to claim 71, wherein the body portion includes a patch having at least one layer of repair fabric.

82. The prosthesis according to claim 81, wherein the at least one layer of repair fabric is susceptible to the formation of adhesions with tissue and organs.

83. The prosthesis according to claim 82, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

84. The prosthesis according to claim 82, 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.

85. The prosthesis according to claim 84, 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.

86. The prosthesis according to claim 81, 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.

87. The prosthesis according to claim 81, 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.

88. The prosthesis according to claim 71, in combination with an overlay patch that has at least one tether opening adapted to slidably receive the at least one tether.

89. 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; 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.

90. The prosthesis according to claim 89, wherein at least one of the first and second layers is susceptible to the formation of adhesions with tissue and organs.

91. The prosthesis according to claim 90, 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.

92. The prosthesis according to claim 91, wherein the at least one of the first and second layers includes a mesh fabric.

93. The prosthesis according to claim 90, wherein each of the first and second layers is susceptible to the formation of adhesions with tissue and organs.

94. The prosthesis according to claim 91, wherein each of the first and second layers includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

95. The prosthesis according to claim 94, wherein each of the first and second layers includes a mesh fabric.

96. The prosthesis according to claim 90, 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.

97. The prosthesis according to claim 96, 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.

98. The prosthesis according to claim 89, 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.

99. The prosthesis according to claim 98, wherein the resilient support member is disposed about at least a portion of the pocket between the first and second layers of repair fabric.

100. The prosthesis according to claim 99, wherein the resilient support member includes a resilient loop.

101. The prosthesis according to claim 89, wherein the at least one tether is susceptible to the formation of adhesions with tissue and organs.

102. The prosthesis according to claim 101, wherein the at least one tether has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

103. The prosthesis according to claim 102, wherein the at least one tether includes a layer of mesh fabric.

104. The prosthesis according to claim 89, 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.

105. The prosthesis according to claim 89, wherein the at least one tether is configured as an elongated strap having a thickness and a width that is greater than the thickness.

106. The prosthesis according to claim 89, wherein the at least one tether includes first and second tethers extending from opposing sides of the access opening.

107. The prosthesis according to claim 106, wherein the access opening has a slit extending across at least a portion of one of the first and second layers.

108. The prosthesis according to claim 89, further comprising an indicator disposed on the at least one tether at a predetermined location to indicate the position of the patch relative to a reference location.

109. The prosthesis according to claim 108, wherein the reference location is an end of a cannula, the predetermined location corresponding to a length of the cannula.

110. The prosthesis according to claim 108, wherein the predetermined location corresponds to a desired insertion depth of the body portion within a patient.

111. The prosthesis according to claim 108, wherein the indicator is preformed on the tether.

112. The prosthesis according to claim 108, wherein the indicator includes a contrasting colored thread.

113. The prosthesis according to claim 89, in combination with an overlay patch that has at least one tether opening adapted to slidably receive the at least one tether.

114. 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.

115. The prosthesis according to claim 114, wherein the length of each of the first and second straps is at least 2.5 inches.

116. The prosthesis according to claim 114, wherein each of the first and second straps is susceptible to the formation of adhesions with tissue and organs.

117. The prosthesis according to claim 116, wherein each of the first and second straps has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

118. The prosthesis according to claim 117, wherein each of the first and second straps includes a layer of mesh fabric.

119. The prosthesis according to claim 114, further comprising an indicator disposed on at least one of the first and second straps at a predetermined location to indicate the position of the at least one layer of repair fabric relative to a reference location.

120. The prosthesis according to claim 119, wherein the indicator is preformed on the at least one of the first and second straps.

121. The prosthesis according to claim 119, wherein the indicator includes a contrasting colored thread.

122. The prosthesis according to claim 114, wherein the at least one layer of repair fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.

123. The prosthesis according to claim 122, wherein the at least one layer of repair fabric includes a layer of mesh fabric.

124. The prosthesis according to claim 114, 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.

125. The prosthesis according to claim 124, 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.

126. The prosthesis according to claim 114, 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.

127. The prosthesis according to claim 126, 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.

128. The prosthesis according to claim 126, wherein the access opening has a slit extending across a portion of the at least one of the first and second layers.

129. The prosthesis according to claim 126, 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.

130. The prosthesis according to claim 114, in combination with an overlay patch that has at least first and second strap openings adapted to slidably receive the first and second straps.

131. A method of repairing an existing or potential tissue or muscle wall defect in a patient, the method comprising steps of:

(a) providing an implantable prosthesis that includes a patch of repair fabric that is constructed and arranged to cover at least a portion of the tissue or muscle wall defect and at least one strap of repair fabric extending from the patch and being constructed and arranged to extend through the tissue or muscle wall defect and protrude outside the patient when the patch is positioned over the defect, the at least one strap having a cross-section with a width and thickness, the width being greater than the thickness;

(b) introducing the patch into the patient;

(c) routing the at least one strap to extend through the defect and to a region that is accessible from outside the patient; and

(d) positioning the patch over the defect.

132. The method according to claim 131, wherein step (b) includes introducing the patch through the defect laparoscopically.

133. The method according to claim 132, wherein step (c) includes extending the at least one strap through a cannula.

134. The method according to claim 133, wherein step (d) includes pulling the at least one strap from a proximal end of the cannula to draw the patch against a distal end of the cannula.

135. The method according to claim 134, wherein step (d) includes withdrawing the cannula from the patient to place the patch against the defect.

136. The method according to claim 131, wherein step (c) includes extending the at least one strap to protrude outside the patient.

137. The method according to claim 136, wherein step (d) includes manipulating the at least one strap outside the patient'"'"'s body.

138. The method according to claim 131, wherein step (d) includes pulling on the at least one strap to draw the patch over the defect.

139. The method according to claim 131, further comprising a step of attaching the at least one strap proximate an edge of the defect.

140. The method according to claim 131, wherein the at least one strap is susceptible to tissue and muscle integration.

141. The method according to claim 140, wherein the patch is susceptible to tissue and muscle integration.

142. The method according to claim 131, wherein the at least one strap includes first and second straps.

143. The method according to claim 131, wherein the prosthesis further includes an indicator disposed on the at least one strap at a predetermined location to indicate the position of the patch relative to a reference location, and wherein step (b) includes inserting the patch into the patient based on the position of the indicator relative to the reference location.

144. The method according to claim 131, wherein the defect is a trocar wound.

145. The method according to claim 131, wherein the defect is an umbilical hernia.