Tissue repair device with a removable support member

• US 20040019360A1
• Filed: 07/25/2002
• Published: 01/29/2004
• Est. Priority Date: 07/25/2002
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Farnsworth, Ted R., Walter, James T., Huppenthal, Joseph A.
• Application Number:
  US10/206,523
• Publication Number:
  US 20040019360A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

The present invention is a composite medical device having an implantable tissue repair or reconstruction component and a resilient support member component that aids in deployment and placement of the implantable component at a surgical site. Following deployment, the support member component is easily removed from the implantable component. The invention is particularly useful in laproscopic and similar surgical procedures.

Claims

1. A medical device comprising:

a resilient support member; and

an implantable device attached to said resilient support member with an adhesive having a bond strength sufficient to hold said resilient support member and implantable device together during implantation procedures and allow said resilient support member to be removed from said implantable device once said implantable device is positioned within a body, wherein said resilient support member assists in deployment and placement of said implantable device during implantation procedures and is completely removed following implantation of said implantable device.

2. The medical device of claim 1 wherein said implantable device has a border area that circumscribes said support member.

3. The medical device of claim 1 wherein said implantable device further comprises an antimicrobial agent.

4. The medical device of claim 1 wherein said device further comprises an abhesive.

5. The medical device of claim 1 wherein said implantable device has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

6. The medical device of claim 5 wherein said markings are located in a border area of said implantable device.

7. The medical device of claim 1 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

8. The medical device of claim 1 wherein said support member has a sequence of perforations that operate to form tear lines as said support member is removed from said implantable device.

9. The medical device of claim 1 wherein said support member has a tear line in the form of a continuous cut therein.

10. The medical device of claim 1 wherein said implantable device comprises a porous expanded polytetrafluoroethylene material.

11. The medical device of claim 10 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

12. The medical device of claim 11 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

13. The medical device of claim 1 wherein said resilient support member comprises a silicone compound.

14. The medical device of claim 1 wherein said resilient support member has a thickness sufficient to provide a tactile step.

15. A medical device comprising:

an implantable sheet of flexible polymeric material having a surface area and a perimeter; and

a resilient polymeric support member releasably adhered to at least a portion of a surface of said implantable sheet material, wherein said support member has a surface area less than said surface area of said implantable sheet and lies within said perimeter of said implantable sheet, and wherein said support member aids in deployment of said implantable sheet in a recipient and is removable from said implantable sheet following deployment of said implantable sheet in said recipient.

16. The medical device of claim 15 wherein said support member lies completely within said border area of said implantable sheet material.

17. The medical device of claim 15 wherein said implantable sheet has a border area that circumscribes said support member.

18. The medical device of claim 15 wherein said implantable sheet further comprises an antimicrobial agent.

19. The medical device of claim 15 wherein said device further comprises an abhesive.

20. The medical device of claim 15 wherein said implantable sheet has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

21. The medical device of claim 20 wherein said markings are located in a border area of said implantable sheet.

22. The medical device of claim 15 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

23. The medical device of claim 15 wherein said support member has a free end.

24. The medical device of claim 15 wherein said support member has a freeable end.

25. The medical device of claim 15 wherein said support member has a sequence of perforations that operate to form tear lines as said support member is removed from said implantable sheet.

26. The medical device of claim 15 wherein said support member has a tear line in the form of a continuous cut therein.

27. The medical device of claim 15 wherein said implantable sheet comprises a porous expanded polytetrafluoroethylene material.

28. The medical device of claim 27 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

29. The medical device of claim 28 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

30. The medical device of claim 15 wherein said polymeric support member comprises a silicone compound.

31. The medical device of claim 15 wherein said support member has a thickness sufficient to provide a tactile step.

32. A medical device comprising:

an implantable sheet of flexible polymeric material having a surface area and a perimeter; and

a resilient polymeric support member releasably adhered to at least a portion of a surface of said implantable sheet material, wherein said support member has at least one freeable end, wherein said support member has a surface area less than said surface area of said implantable sheet and lies within said perimeter of said implantable sheet, and wherein said support member aids in deployment of said implantable sheet in a recipient and is removable from said implantable sheet with the aid of said at least one freeable end following deployment of said implantable sheet in said recipient.

33. The medical device of claim 32 wherein said support member lies completely within said border area of said implantable sheet material.

34. The medical device of claim 32 wherein said implantable sheet has a border area that circumscribes said support member.

35. The medical device of claim 32 wherein said implantable sheet further comprises an antimicrobial agent.

36. The medical device of claim 32 wherein said device further comprises an abhesive.

37. The medical device of claim 32 wherein said implantable sheet has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

38. The medical device of claim 37 wherein said markings are located in a border area of said implantable sheet.

39. The medical device of claim 32 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

40. The medical device of claim 32 wherein said support member has a free end.

41. The medical device of claim 32 wherein said support member has a freeable end.

42. The medical device of claim 32 wherein said support member has a sequence of perforations that operate to form tear lines as said support member is removed from said implantable sheet.

43. The medical device of claim 32 wherein said support member has a tear line in the form of a continuous cut therein.

44. The medical device of claim 32 wherein said implantable sheet comprises a porous expanded polytetrafluoroethylene material.

45. The medical device of claim 44 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

46. The medical device of claim 45 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

47. The medical device of claim 32 wherein said polymeric support member comprises a silicone compound.

48. The medical device of claim 32 wherein said support member has a thickness sufficient to provide a tactile step.

49. A medical device comprising:

an implantable sheet of flexible polymeric material having a surface area and a perimeter; and

a resilient polymeric support member releasably adhered to at least a portion of a surface of said implantable sheet material, wherein said support member has at least one free end, wherein said support member has a surface area less than said surface area of said implantable sheet and lies within said perimeter of said implantable sheet, and wherein said support member aids in deployment of said implantable sheet in a recipient and is removable from said implantable sheet with the aid of said at least one free end following deployment of said implantable sheet in said recipient.

50. The medical device of claim 49 wherein said support member lies completely within the border area of the implantable sheet material.

51. The medical device of claim 49 wherein said implantable sheet has a border area that circumscribes said support member.

52. The medical device of claim 49 wherein said device further comprises an abhesive.

53. The medical device of claim 49 wherein said implantable sheet further comprises an anti-microbial agent.

54. The medical device of claim 49 wherein said implantable sheet has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

55. The medical device of claim 54 wherein said markings are located in a border area of said implantable sheet.

56. The medical device of claim 49 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

57. The medical device of claim 49 wherein said support member has a free end.

58. The medical device of claim 49 wherein said support member has a freeable end.

59. The medical device of claim 49 wherein said support member has a sequence of perforations that operate to form tear lines as said support member is removed from said implantable sheet.

60. The medical device of claim 49 wherein said support member has a tear line in the form of a continuous cut therein.

61. The medical device of claim 49 wherein said implantable sheet comprises a porous expanded polytetrafluoroethylene material.

62. The medical device of claim 61 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

63. The medical device of claim 62 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

64. The medical device of claim 49 wherein said polymeric support member comprises a silicone compound.

65. The medical device of claim 49 wherein said support member has a thickness sufficient to provide a tactile step.

66. A medical device comprising:

an implantable sheet of flexible polymeric material having a surface area, a perimeter, and an anti-microbial agent; and

a resilient polymeric support member releasably adhered to at least a portion of a surface of said implantable sheet material, wherein said support member is in the form of a coil having a free end, wherein said support member has a surface area less than said surface area of said implantable sheet and lies within said perimeter of said implantable sheet, and wherein said support member aids in deployment of said implantable sheet in a recipient and is removable from said implantable sheet with the aid of said free end following deployment of said implantable sheet in said recipient.

67. The medical device of claim 66 wherein said support member lies completely within said border area of said implantable sheet material.

68. The medical device of claim 66 wherein said implantable sheet has a border area that circumscribes said support member.

69. The medical device of claim 66 wherein said support member further comprises an abhesive.

70. The medical device of claim 66 wherein said implantable sheet has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

71. The medical device of claim 66 wherein said markings are located in a border area of said implantable sheet.

72. The medical device of claim 66 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

73. The medical device of claim 66 wherein said support member has a sequence of perforations that delimit said coil form.

74. The medical device of claim 66 wherein said support member has a continuous cut therein that delimits said coil form.

75. The medical device of claim 66 wherein said implantable sheet comprises a porous expanded polytetrafluoroethylene material.

76. The medical device of claim 75 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

77. The medical device of claim 76 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

78. The medical device of claim 66 wherein said polymeric support member comprises a silicone compound.

79. The medical device of claim 66 wherein said support member has a thickness sufficient to provide a tactile step.

80. A medical device comprising:

an implantable sheet of flexible polymeric material having a surface area and a perimeter; and

a resilient polymeric support member releasably adhered to at least a portion of a surface of said implantable sheet material, wherein said support member is in the form of a coil having a free end, wherein said support member has a surface area less than said surface area of said implantable sheet and lies within said perimeter of said implantable sheet, and wherein said support member aids in deployment of said implantable sheet in a recipient and is removable from said implantable sheet with the aid of said free end following deployment of said implantable sheet in said recipient.

81. The medical device of claim 80 wherein said support member lies completely within said border area of said implantable sheet material.

82. The medical device of claim 80 wherein said implantable sheet has a border area that circumscribes said support member.

83. The medical device of claim 80 wherein said support member further comprises an abhesive.

84. The medical device of claim 80 wherein said implantable sheet has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

85. The medical device of claim 84 wherein said markings are located in a border area of said implantable sheet.

86. The medical device of claim 80 wherein said support member has one or more markings adapted to aid visual orientation of said medical device with respect to an implantation site.

87. The medical device of claim 80 wherein said support member further comprises a framework.

88. The medical device of claim 87 wherein said framework is embedded within said support member.

89. The medical device of claim 80 wherein said support member has a sequence of perforations that delimit said coil form.

90. The medical device of claim 80 wherein said support member has a continuous cut therein that delimits said coil form.

91. The medical device of claim 80 wherein said implantable sheet comprises a porous expanded polytetrafluoroethylene material.

92. The medical device of claim 91 wherein said porous expanded polytetrafluoroethylene material comprises a first layer and a second layer.

93. The medical device of claim 92 wherein said first layer is sufficiently porous to permit ingrowth of cells or cellular processes therewithin and wherein said second layer does not support attachment of tissue thereto.

94. The medical device of claim 80 wherein said polymeric support member comprises a silicone compound.

95. The medical device of claim 80 wherein said support member has a thickness sufficient to provide a tactile step.

96. An implantation aid for an implantable device comprising

a resilient member;

an adhesive attached to said resilient member, said adhesive having sufficient bond strength to maintain attachment of said resilient member to an implantable device during implantation procedures, while allowing said resilient member to be readily removed from said implantable device once said implantable device is positioned within a body;

wherein said resilient member assists in deploying and positioning said implantable device during implantation procedures while being completely removed following implantation of said implantable device.

97. The implantation aid of claim 96 wherein

said resilient member has a length and a width;

said length of said resilient member exceeds its width; and

said width of said resilient member is at least 1 cm.

98. The implantation aid of claim 96 wherein said resilient member comprises a sheet of material that is attached to an implantable device comprising a sheet.