Implantable prosthesis

• US 7,806,905 B2
• Filed: 04/10/2009
• Issued: 10/05/2010
• Est. Priority Date: 08/02/2002
• Status: Expired due to Term

• Current Assignee: Davol Incorporated (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Torres, Donna Schultz, Ford, Steven Palmer
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US12/422,089
• Publication Number:
  US 20090198260A1
• Time in Patent Office: 543 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, 623/11.11
• 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

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 of 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. A method of repairing a tissue or muscle wall defect in a patient, the method comprising acts of:

(a) introducing an implantable prosthesis into the patient, the implantable prosthesis including a patch and at least one strap extending from the patch, the at least one strap having a cross-section with a width and a thickness, the width being greater than the thickness;

(b) positioning the patch on one side of the defect with the at least one strap extending through the defect so that an accessible portion thereof is on the other side of the defect;

(c) pulling the accessible portion of the at least one strap that is on the other side of the defect to place the patch against tissue or muscle adjacent the defect; and

(d) securing the prosthesis in position at the defect.

2. The method according to claim 1, wherein act (d) includes securing the at least one strap at a margin of the defect.

3. The method according to claim 2, further comprising, after act (d), removing excess length of the at least one strap.

4. The method according to claim 2, further comprising, after act (d), trimming and then discarding the excess length of the at least one strap.

5. The method according to claim 2, wherein act (d) includes suturing, stapling, or tacking, the at least one strap.

6. The method according to claim 1, wherein act (d) includes securing the prosthesis through the at least one strap.

7. The method according to claim 1, further comprising folding the patch prior to introducing the prosthesis into the patient.

8. The method according to claim 7, further comprising unfolding the patch into a deployed configuration to cover the defect after introducing the prosthesis into the patient.

9. The method according to claim 8, wherein the patch includes a support member that assists unfolding the patch.

10. The method according to claim 9, wherein the patch includes a barrier layer to resist tissue attachment to the patch.

11. The method according to claim 8, wherein the patch includes a support member that aids in expansion of the patch.

12. The method according to claim 8, wherein the patch includes a support member that reinforces the patch.

13. The method according to claim 8, wherein the patch includes a support member that contributes to the stability of the patch.

14. The method according to claim 8, wherein act (a) includes delivering the prosthesis into the patient through a cannula that is positioned at the defect.

15. The method according to claim 14, wherein act (b) includes advancing the patch out of a distal end of the cannula.

16. The method according to claim 15, wherein act (c) includes drawing the patch toward the distal end of the cannula.

17. The method according to claim 1, wherein the at least one strap includes a pair of straps that are connected to the patch at spaced apart locations.

18. The method according to claim 17, wherein the pair of straps are connected to an inner portion of the patch.

19. The method according to claim 1, wherein the patch includes multiple layers of biocompatible material.

20. The method according to claim 19, wherein the patch includes absorbable and non-absorbable layers.

21. The method according to claim 20, wherein the patch includes at least one non-absorbable mesh layer and an absorbable barrier layer.

22. The method according to claim 21, wherein the at least one strap extends from a surface of the patch opposite the barrier layer.

23. The method according to claim 21, wherein the barrier layer is adhesion resistant.

24. The method according to claim 21, wherein the barrier layer minimizes tissue attachment to the patch.

25. The method according to claim 21, wherein the barrier layer reduces tissue adhesions to the patch.

26. The method according to claim 1, wherein the tissue or muscle wall defect is in the abdominal wall.

27. The method according to claim 26, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

28. The method according to claim 1, wherein act (b) includes the portion of the at least one strap extending beyond a margin of the other side of the defect.

29. The method according to claim 1, wherein act (c) includes pulling the accessible portion of the at least one strap that is on the other side of the defect from outside the patient.

30. A method of repairing a tissue or muscle wall defect in a patient, the method comprising acts of:

(a) introducing an implantable prosthesis into the patient, the implantable prosthesis including a patch and at least one strap extending from the patch, the at least one strap having a cross-section with a width and a thickness, the width being greater than the thickness;

(b) positioning the patch on one side of the defect with the at least one strap extending through the defect so that a portion thereof is on the other side of the defect;

(c) manipulating the portion of the at least one strap that is on the other side of the defect to position the patch relative to the tissue or muscle wall defect; and

(d) securing the prosthesis in position at the defect.

31. The method according to claim 30, wherein act (d) includes securing the at least one strap at a margin of the defect.

32. The method according to claim 31, further comprising, after act (d), removing excess length of the at least one strap.

33. The method according to claim 31, wherein act (d) includes suturing, stapling, or tacking, the at least one strap.

34. The method according to claim 30, further comprising folding the patch prior to introducing the prosthesis into the patient.

35. The method according to claim 34, further comprising unfolding the patch into a deployed configuration to cover the defect after introducing the prosthesis into the patient.

36. The method according to claim 35, wherein the patch includes a support member that assists unfolding the patch.

37. The method according to claim 36, wherein the patch includes a barrier layer to resist tissue attachment to the patch.

38. The method according to claim 35, wherein the patch includes a support member that aids in expansion of the patch.

39. The method according to claim 35, wherein the patch includes a support member that reinforces the patch.

40. The method according to claim 35, wherein the patch includes a support member that contributes to the stability of the patch.

41. The method according to claim 30, wherein the at least one strap includes a pair of straps that are connected to the patch at spaced apart locations.

42. The method according to claim 41, wherein the pair of straps are connected to an inner portion of the patch.

43. The method according to claim 30, wherein the patch includes multiple layers of biocompatible material.

44. The method according to claim 43, wherein the patch includes absorbable and non-absorbable layers.

45. The method according to claim 44, wherein the patch includes at least one non-absorbable mesh layer and an absorbable barrier layer.

46. The method according to claim 42, wherein the at least one strap extends from a surface of the patch opposite the barrier layer.

47. The method according to claim 45, wherein the barrier layer is adhesion resistant.

48. The method according to claim 45, wherein the barrier layer minimizes tissue attachment to the patch.

49. The method according to claim 45, wherein the barrier layer reduces tissue adhesions to the patch.

50. The method according to claim 30, wherein act (c) includes pulling the portion of the at least one strap on the other side of the defect to deploy the patch against the tissue or muscle wall defect.

51. The method according to claim 31, wherein act (a) includes delivering the prosthesis into the patient through a cannula that is positioned at the defect.

52. The method according to claim 51, wherein act (b) includes advancing the patch out of a distal end of the cannula.

53. The method according to claim 52, wherein act (c) includes drawing the patch toward the distal end of the cannula.

54. The method according to claim 30, wherein the tissue or muscle wall defect is in the abdominal wall.

55. The method according to claim 54, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

56. The method according to claim 31, further comprising, after act (d), removing excess length of the at least one strap.

57. The method according to claim 31, further comprising, after act (d), trimming and then discarding the excess length of the at least one strap.

58. The method according to claim 31, wherein act (b) includes the portion of the at least one strap extending beyond a margin of the other side of the defect.

59. The method according to claim 31, wherein act (c) includes manipulating the portion of the at least one strap that is on the other side of the defect from outside the patient.

60. A method of repairing a tissue or muscle wall defect in a patient, the method comprising acts of:

(a) introducing an implantable prosthesis into the patient, the implantable prosthesis including a multi-layer patch of absorbable and non-absorbable layers and a pair of straps extending from the patch, each of the straps having a cross-section with a width and a thickness, the width being greater than the thickness;

(b) positioning the patch on one side of the defect with the pair of straps extending through the defect so that an accessible portion thereof is on the other side of the defect;

(c) manipulating the accessible portion of the pair of straps on the other side of the defect to position the patch relative to the defect; and

(d) securing the pair of straps to anatomy to secure the patch in position at covering the defect.

61. The method according to claim 60, wherein act (a) includes delivering the prosthesis into the patient through a cannula that is positioned at the defect.

62. The method according to claim 61, wherein act (b) includes advancing the patch out of a distal end of the cannula.

63. The method according to claim 62, wherein act (c) includes drawing the patch toward the distal end of the cannula.

64. The method according to claim 63, wherein act (c) includes removing the cannula from the defect.

65. The method according to claim 60, further comprising, after act (d), removing excess length of the pair of straps.

66. The method according to claim 60, further comprising folding the patch prior to introducing the prosthesis into the patient.

67. The method according to claim 66, further comprising unfolding the patch into a deployed configuration to cover the defect after introducing the prosthesis into the patient.

68. The method according to claim 61, wherein the patch includes a support member that aids in expansion of the patch.

69. The method according to claim 61, wherein the patch includes a support member that reinforces the patch.

70. The method according to claim 61, wherein the patch includes a support member that contributes to the stability of the patch.

71. The method according to claim 61, wherein the support member is ring-shaped.

72. The method according to claim 60, wherein the patch includes an adhesion resistant barrier layer.

73. The method according to claim 60, wherein the patch includes a barrier layer that minimizes tissue attachment to the patch.

74. The method according to claim 60, wherein the patch includes a barrier layer that reduces tissue adhesions to the patch.

75. The method according to claim 60, wherein the pair of straps are connected to the patch at spaced apart locations.

76. The method according to claim 60, wherein the pair of straps are connected to an inner portion of the patch.

77. The method according to claim 60, wherein the patch includes at least one non-absorbable mesh layer and an absorbable barrier layer.

78. The method according to claim 77, wherein the pair of straps extend from a surface of the patch opposite the barrier layer.

79. The method according to claim 60, wherein act (c) includes pulling the accessible portion of the pair of straps on the other side of the defect to deploy the patch against the tissue or muscle wall defect.

80. The method according to claim 60, wherein the tissue or muscle wall defect is in the abdominal wall.

81. The method according to claim 80, wherein the defect is one of an umbilical hernia, incisional hernia or a trocar puncture.

82. The method according to claim 60, further comprising, after act (d), trimming and then discarding the excess length of the pair of straps.

83. The method according to claim 60, wherein act (d) includes suturing, stapling, or tacking, the pair of straps.

84. The method according to claim 60, wherein the pair of straps are secured at a margin of the defect.

85. The method according to claim 60, wherein act (b) includes the portion of the pair of straps extending beyond a margin of the other side of the defect.

86. The method according to claim 60, wherein act (c) includes manipulating the accessible portion of the pair of straps on the other side of the defect from outside the patient.