CA2485275A1 - Prosthetic repair fabric with erosion resistant edge - Google Patents

Prosthetic repair fabric with erosion resistant edge Download PDF

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Publication number
CA2485275A1
CA2485275A1 CA002485275A CA2485275A CA2485275A1 CA 2485275 A1 CA2485275 A1 CA 2485275A1 CA 002485275 A CA002485275 A CA 002485275A CA 2485275 A CA2485275 A CA 2485275A CA 2485275 A1 CA2485275 A1 CA 2485275A1
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CA
Canada
Prior art keywords
edge
layer
fabric
barrier
prosthetic repair
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002485275A
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French (fr)
Other versions
CA2485275C (en
Inventor
Valerie Vadurro
Roger E. Darois
Stephen N. Eldridge
Michael J. Lee
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CR Bard Inc
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Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to CA2733211A priority Critical patent/CA2733211C/en
Publication of CA2485275A1 publication Critical patent/CA2485275A1/en
Application granted granted Critical
Publication of CA2485275C publication Critical patent/CA2485275C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063Implantable repair or support meshes, e.g. hernia meshes

Abstract

An implantable prosthesis (20) is provided for repairing or augmenting anatomical weaknesses or defects, and is particularly suitable for the repai r of soft tissue and muscle wall openings. The prosthesis may include a layer of fabric (22) that is constructed and arranged to allow tissue ingrowth and is susceptible to erosion into and the formation of adhesions with tissue and organs. The prosthesis is configured to inhibit edge erosion of the prosthes is into surrounding tissue or organs. The prosthesis may include an erosion resistant edge (114) to buffer and edge (54) of the fabric from the adjacent tissue or organs. The erosion resistant edge may be provided along an openin g that is adapted to receive a tube-like structure, such as the esophagus (202 ).

Claims (106)

1. A prosthetic repair fabric for repairing a tissue or muscle wall defect, the prosthetic repair fabric comprising:
a body of implantable, biocompatible repair fabric, the body including first and second surfaces and a body edge that extends from the first surface to the second surface, the body including first and second layers joined to each other along an inverted seam that extends inwardly from the body edge and between the first and second layers to inhibit erosion of the tissue and organs.
2. The prosthetic repair fabric according to claim 1, wherein the first layer includes a layer of repair fabric that is susceptible to erosion into and the formation of adhesions with tissue and organs.
3. The prosthetic repair fabric according to claim 2, wherein the layer of fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.
4. The prosthetic repair fabric according to claim 2, further comprising an edge barrier that inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed about at least a portion of the body edge.
5. The prosthetic repair fabric according to claim 4, wherein the edge barrier extends over the portion of the body edge and over a portion of an outer surface of the first layer proximate the body edge.
6. The prosthetic repair fabric according to claim 4, wherein the edge barrier is joined to the first and second layers at the at least one seam.
7. The prosthetic repair fabric according to claim 4, wherein the edge barrier is formed from ePTFE.
8. The prosthetic repair fabric according to claim 4, wherein the body includes an opening that is adapted to receive a tube-like structure, the body edge including an opening edge that defines the opening in the body, and the edge barrier includes an opening edge barrier that extends about a portion of the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.
9. The prosthetic repair fabric according to claim 2, wherein the first layer is formed from one of polypropylene mesh and PTFE mesh.
10. The prosthetic repair fabric according to claim 1, wherein the second layer includes a barrier material that inhibits the formation of adhesions with tissue and organs.
11. The prosthetic repair fabric according to claim 10, wherein the second layer is formed from ePTFE.
12. The prosthetic repair fabric according to claim 1, wherein the first layer is joined to the second layer by a series of stitches along the at least one seam.
13. The prosthetic repair fabric according to claim 1, wherein the first layer is symmetric to the second layer.
14. The prosthetic repair fabric according to claim 1, wherein the body includes an opening that is adapted to receive a tube-like structure, the body edge including an opening edge that defines the opening in the body
15. The prosthetic repair fabric according to claim 14, wherein the prosthetic repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.
16. The prosthetic repair fabric according to claim 1, wherein the first and second layers are formed of materials having substantially equal melting temperatures.
17. The prosthetic repair fabric according to claim 1, wherein the first layer is joined to the second layer inwardly from the body edge to reduce billowing of the second layer.
18. A prosthetic repair fabric for repairing a tissue or muscle wall defect, the prosthetic repair fabric comprising:
a body of implantable, biocompatible repair fabric, the body including first and second surfaces and a body edge extending from the first surface to the second surface, the first surface adapted to face the muscle or tissue wall defect and the second surface adapted to face away from the defect, the body including first and second layers, each of the first and second layers having an outer surface and an inner surface, the outer surface of the first layer forming a portion of the first surface of the body and the outer surface of the second layer forming the second surface of the body with the inner surface of the first layer facing the inner surface of the second layer, the first and second layers being joined to each other along at least one seam, the at least one seam being disposed inwardly of the body edge between the inner surfaces of the first and second layers to inhibit erosion of the tissue and organs by the body edge.
19. The prosthetic repair fabric according to claim 18, wherein the first layer includes a layer of repair fabric that is susceptible to erosion into and the formation of adhesions with tissue and organs.
20. The prosthetic repair fabric according to claim 19, wherein the layer of fabric includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.
21. The prosthetic repair fabric according to claim 19, further comprising an edge barrier that inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed about at least a portion of the body edge.
22. The prosthetic repair fabric according to claim 21, wherein the edge barrier extends over the portion of the body edge and over a portion of the outer surface of the first layer proximate the portion of the body edge.
23. The prosthetic repair fabric according to claim 21, wherein the edge barrier is joined to the first and second layers at the at least one seam.
24. The prosthetic repair fabric according to claim 21, wherein the edge barrier is formed from ePTFE.
25. The prosthetic repair fabric according to claim 21, wherein the body includes an opening that is adapted to receive a tube-like structure, the body edge including an opening edge that defines the opening in the body, and the edge barrier includes an opening edge barrier that extends about a portion of the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.
26. The prosthetic repair fabric according to claim 19, wherein the first layer is formed from one of polypropylene mesh and PTFE mesh.
27. The prosthetic repair fabric according to claim 18, wherein the second layer includes a barrier material that inhibits the formation of adhesions with tissue and organs.
28. The prosthetic repair fabric according to claim 27, wherein the second layer is formed from ePTFE.
29. The prosthetic repair fabric according to claim 18, wherein the first layer is joined to the second layer by a series of stitches along the at least one seam.
30. The prosthetic repair fabric according to claim 18, wherein the first layer is symmetric to the second layer.
31. The prosthetic repair fabric according to claim 18, wherein a shape of the first layer has the same shape as a shape of the second layer, wherein the shape of the second layer is proportionately larger than the shape of the first layer.
32. The prosthetic repair fabric according to claim 31, wherein the body edge is formed entirely by the second layer.
33. The prosthetic repair fabric according to claim 18, wherein the body includes an opening that is adapted to receive a tube-like structure, the body edge including an opening edge that defines the opening in the body
34. The prosthetic repair fabric according to claim 33, wherein the prosthetic repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.
35. The prosthetic repair fabric according to claim 18, wherein the first and second layers are formed of materials having substantially equal melting temperatures.
36. The prosthetic repair fabric according to claim 18, wherein the at least one seam extends inwardly from the first surface of the body.
37. The prosthetic repair fabric according to claim 36, wherein the body edge is formed entirely of the second layer.
38. The prosthetic repair fabric according to claim 18, wherein the body edge includes portions of the first layer and the second layer, the at least one seam extending inwardly from the body edge and between the first and second layers.
39. The prosthetic repair fabric according to claim 18, wherein the first layer is joined to the second layer inwardly from the body edge to prevent reduce of the second layer.
40. A method of fabricating a prosthetic repair fabric for repairing a tissue or muscle wall defect, the method comprising:
(a) joining an outer edge of a first layer of implantable, biologically compatible material to an outer edge of a second layer of implantable, biologically compatible material, each of the first and second layers including first and second surfaces, the first and second layers being joined to each other with the first surface of the first layer facing the second surface of the second layer; and (b) subsequent to step (a), inverting the first and second layers so that the second surface of the first layer is facing the first surface of the second layer and the outer edges of the first and second layers extend inwardly between the second surface of the first layer and the first surface of the second layer, thereby isolating the outer edges of the first and second layers from tissue and organs so as to inhibit erosion into the tissue and organs when the prosthetic repair fabric is implanted to repair the tissue or muscle wall defect.
41. The method according to claim 40, wherein the first layer is susceptible to the formation of adhesions with and erosion into tissue and organs.
42. The method according to claim 41, wherein the first layer includes a plurality of interstices that are constructed and arranged to allow tissue ingrowth.
43. The method according to claim 41, wherein the first layer is formed from one of polypropylene mesh and PTFE mesh.
44. The method according to claim 40, further comprising a step (c) of placing an edge barrier between the first surface of the first layer and the second surface of the second layer, the edge barrier adapted to inhibit the formation of adhesions with tissue and organs, and wherein step (a) includes joining an outer edge of the edge barrier to the outer edge of the first layer and the outer edge of the second layer.
45. The method according to claim 44, wherein step (b) inverting the edge barrier so that a portion of the first surface of the first layer is isolated from tissue and organs by the edge barrier along a portion of a periphery of the prosthetic repair fabric.
46. The method according to claim 45, further comprising a step (d) attaching a portion of the edge barrier to the first layer subsequent to step (b).
47. The method according to claim 40, wherein step (a) includes forming a gap along the at least one seam.
48. The method according to claim 47, wherein step (b) includes pulling the first and second layers through the gap to invert the first and second layers.
49. The method according to claim 40, wherein the second layer is a surface barrier that inhibits the formation of adhesions with tissue and organs.
50. The method according to claim 40, wherein step (a) includes stitching the first layer to the second layer along the at least one seam.
51. The method according to claim 40, further comprising step (e) of attaching a portion of the first layer to a portion of the second layer subsequent to the step (b).
52. The method according to claim 51, wherein step (e) includes attaching the portion of the first layer to the portion of the second layer with intermittent stitches.
53. The method according to claim 51, wherein step (e) includes attaching the portion of the first layer to the portion of the second layer with continuous stitches.
54. The method according to claim 53, wherein the continuous stitches are parallel to and spaced from a peripheral edge of the prosthetic repair fabric.
55. The method according to claim 40, wherein the first layer is symmetric to the second layer.
56. The method according to claim 40, wherein the first and second layers have similar shapes, the first layer being proportionately larger than the second layer.
57. A prosthetic repair fabric for repairing a tissue or muscle wall defect, the prosthetic repair fabric comprising:
a layer of fabric that is susceptible to erosion into and the formation of adhesions with tissue and organs, the layer of fabric 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; and an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions with tissue and organs, the edge barrier being disposed on a portion of the first and second surfaces adjacent the fabric edge and extending from the first surface to the second surface over the fabric edge, the edge barrier having an inner surface that is spaced from the fabric edge in a direction normal to the fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.
58. The prosthetic repair fabric according to claim 57, wherein the layer of fabric includes an opening that is adapted to receive a tube-like structure, the fabric edge including an opening edge that extends along the opening, the edge barrier extending about the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.
59. The prosthetic repair fabric according to claim 58, wherein the prosthetic repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.
60. The prosthetic repair fabric according to claim 58, wherein the opening is a partial opening that is adapted to partially surround a portion of the tube-like structure.
61. The prosthetic repair fabric according to claim 57, 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 layer of repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the prosthetic repair fabric is placed in the patient.
62. The prosthetic repair fabric according to claim 61, wherein the surface barrier is disposed on substantially the entire second surface of the layer of repair fabric.
63. The prosthetic repair fabric according to claim 61, wherein the edge barrier is an integral extension of the surface barrier that is wrapped about the fabric edge.
64. The prosthetic repair fabric according to claim 57, wherein the edge barrier includes first and second barrier layers, the first barrier layer being disposed on the portion of the first surface of the layer of fabric and extending beyond the fabric edge, the second barrier layer being disposed on the portion of the second surface of the layer of fabric and extending beyond the fabric edge to overlie the first barrier layer, portions of the first and second barrier layers extending beyond the fabric edge being attached directly to each other to isolate the fabric edge and form the inner surface of the edge barrier spaced from the fabric edge.
65. The prosthetic repair fabric according to claim 64, wherein the second barrier layer includes a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on and covering the second surface of the layer of repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the prosthetic repair fabric is placed in the patient.
66. The prosthetic repair fabric according to claim 57, wherein the edge barrier includes a barrier layer that wraps about the fabric edge from the portion of the first surface of the layer of fabric to the portion of the second surface of the layer of fabric.
67. The prosthetic repair fabric according to claim 57, wherein the layer of repair fabric has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.
68. The prosthetic repair fabric according to claim 57, wherein the fabric edge includes an outer peripheral edge, and wherein the prosthetic repair fabric further comprises an outer edge barrier that extends about at least a portion of the outer peripheral edge to inhibit the formation of adhesions between the portion of the outer peripheral edge and adjacent tissue or organs.
69. The prosthetic repair fabric according to claim 57, wherein the layer of fabric is formed from one of polypropylene mesh and PTFE mesh.
70. The prosthetic repair fabric according to claim 57, wherein the edge barrier is formed from ePTFE.
71. The prosthetic repair fabric according to claim 57, wherein the gap has a length of approximately 0.5 mm to approximately 2.5 mm in the normal direction.
72. The prosthetic repair fabric according to claim 71, wherein the gap has a length of approximately 0.5 mm to approximately 1.5 mm in the normal direction.
73. The prosthetic repair fabric according to claim 71, wherein the gap has a length of approximately 1 mm to approximately 2.5 mm in the normal direction.
74. The prosthetic repair fabric according to claim 57, wherein the edge barrier is softer than the layer of fabric.
75. The prosthetic repair fabric according to claim 57, wherein the edge barrier is smoother than the layer of fabric.
76. The prosthetic repair fabric according to claim 57, wherein the edge barrier is more deformable than the layer of fabric.
77. The prosthetic repair fabric according to claim 76, wherein the inner surface of the edge barrier is adapted to collapse towards the fabric edge when a force normal to the fabric edge is applied to the edge barrier.
78. The prosthetic repair fabric according to claim 76, wherein the edge barrier is adapted to bend relative to the fabric edge when a force normal to the fabric edge is applied to the edge barrier.
79. The prosthetic repair fabric according to claim 57, wherein fabric edge has an edge height and the edge barrier has an outer surface opposite the inner surface of the edge barrier, the outer surface having a surface height that is greater than the edge height.
80. The prosthetic repair fabric according to claim 57, wherein the edge barrier is constructed and arranged to isolate the fabric edge from the tissue and organs when the prosthetic repair fabric is placed near the tissue or muscle wall defect.
81. The prosthetic repair fabric according to claim 57, wherein the layer of fabric is substantially flat.
82. A prosthetic repair fabric for repairing a tissue or muscle wall defect, 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 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 muscle or tissue wall defect and the second surface adapted to face away from the defect; and an edge barrier that inhibits erosion into tissue and organs and inhibits the formation of adhesions, the edge barrier being disposed at all times over the fabric edge, the edge barrier having an inner surface that is spaced from the fabric edge in a direction normal to fabric edge to form a gap between the inner face of the edge barrier and the fabric edge to inhibit erosion of the tissue and organs by the fabric edge and to inhibit the formation of adhesions to the fabric edge.
83. The prosthetic repair fabric according to claim 82, wherein the layer of fabric includes an opening that is adapted to receive a tube-like structure, the fabric edge including an opening edge that extends along the opening, the edge barrier extending about the opening edge to inhibit erosion into and the formation of adhesions with the tube-like structure.
84. The prosthetic repair fabric according to claim 83, wherein the prosthetic repair fabric is constructed and arranged to be placed proximate an esophageal hiatus, the opening being adapted to receive the esophagus.
85. The prosthetic repair fabric according to claim 83, wherein the opening is a partial opening that is adapted to partially surround a portion of the tube-like structure.
86. The prosthetic repair fabric 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 the second surface of the layer of repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the prosthetic repair fabric is placed in the patient.
87. The prosthetic repair fabric according to claim 86, wherein the surface barrier is disposed on substantially the entire second surface of the layer of repair fabric.
88. The prosthetic repair fabric according to claim 86, wherein the edge barrier is an integral extension of the surface barrier that is wrapped about the fabric edge.
89. The prosthetic repair fabric according to claim 82, wherein the edge barrier includes first and second barrier layers, the first barrier layer being disposed on the portion of the first surface of the layer of fabric and extending beyond the fabric edge, the second barrier layer being disposed on the portion of the second surface of the layer of fabric and extending beyond the fabric edge to overlie the first barrier layer, portions of the first and second barrier layers extending beyond the fabric edge being attached directly to each other to isolate the fabric edge and form the inner surface of the edge barrier spaced from the fabric edge.
90. The prosthetic repair fabric according to claim 89, wherein the second barrier layer includes a surface barrier that inhibits the formation of adhesions with tissue and organs, the surface barrier being disposed on and covering the second surface of the layer of repair fabric to inhibit the formation of adhesions between the portion of the second surface and adjacent tissue and organs when the prosthetic repair fabric is placed in the patient.
91. The prosthetic repair fabric according to claim 82, wherein the edge barrier includes a barrier layer that wraps about the fabric edge from the portion of the first surface of the layer of fabric to the portion of the second surface of the layer of fabric.
92. The prosthetic repair fabric according to claim 82, wherein the layer of repair fabric has a plurality of interstices that are constructed and arranged to allow tissue ingrowth.
93. The prosthetic repair fabric according to claim 82, wherein the fabric edge includes an outer peripheral edge, and wherein the prosthetic repair fabric further comprises an outer edge barrier that extends about at least a portion of the outer peripheral edge to inhibit the formation of adhesions between the portion of the outer peripheral edge and adjacent tissue or organs.
94. The prosthetic repair fabric according to claim 82, wherein the layer of fabric is formed from one of polypropylene mesh and PTFE mesh.
95. The prosthetic repair fabric according to claim 82, wherein the edge barrier is formed from ePTFE.
96. The prosthetic repair fabric according to claim 82, wherein the gap has a length of approximately 0.5 mm to approximately 2.5 mm in the normal direction.
97. The prosthetic repair fabric according to claim 96, wherein the gap has a length of approximately 0.5 mm to approximately 1.5 mm in the normal direction.
98. The prosthetic repair fabric according to claim 96, wherein the gap has a length of approximately 1 mm to approximately 2.5 mm in the normal direction.
99. The prosthetic repair fabric according to claim 82, wherein the edge barrier is softer than the layer of fabric.
100. The prosthetic repair fabric according to claim 82, wherein the edge barrier is smoother than the layer of fabric.
101. The prosthetic repair fabric according to claim 82, wherein the edge barrier is more deformable than the layer of fabric.
102. The prosthetic repair fabric according to claim 101, wherein the inner surface of the edge barrier is adapted to collapse towards the fabric edge when a force normal to the fabric edge is applied to the edge barrier.
103. The prosthetic repair fabric according to claim 101, wherein the edge barrier is adapted to bend relative to the fabric edge when a force normal to the fabric edge is applied to the edge barrier.
104. The prosthetic repair fabric according to claim 82, wherein fabric edge has an edge height and the edge barrier has an outer surface opposite the inner surface of the edge barrier, the outer surface having a surface height that is greater than the edge height.
105. The prosthetic repair fabric according to claim 82, wherein the edge barrier is constructed and arranged to isolate the fabric edge from the tissue and organs when the prosthetic repair fabric is placed near the tissue or muscle wall defect.
106. The prosthetic repair fabric according to claim 82, wherein the layer of fabric is substantially flat.
CA2485275A 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge Expired - Fee Related CA2485275C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2733211A CA2733211C (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/143,746 2002-05-10
US10/143,746 US6736854B2 (en) 2002-05-10 2002-05-10 Prosthetic repair fabric with erosion resistant edge
PCT/US2003/010871 WO2003094783A1 (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2733211A Division CA2733211C (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge

Publications (2)

Publication Number Publication Date
CA2485275A1 true CA2485275A1 (en) 2003-11-20
CA2485275C CA2485275C (en) 2011-05-24

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CA2733211A Expired - Fee Related CA2733211C (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge
CA2485275A Expired - Fee Related CA2485275C (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge

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CA2733211A Expired - Fee Related CA2733211C (en) 2002-05-10 2003-04-09 Prosthetic repair fabric with erosion resistant edge

Country Status (6)

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US (1) US6736854B2 (en)
EP (1) EP1503694B1 (en)
JP (1) JP4733384B2 (en)
CA (2) CA2733211C (en)
ES (1) ES2387268T3 (en)
WO (1) WO2003094783A1 (en)

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CA2733211A1 (en) 2003-11-20
US20030212461A1 (en) 2003-11-13
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EP1503694B1 (en) 2012-05-09
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JP4733384B2 (en) 2011-07-27
EP1503694A1 (en) 2005-02-09

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