Sling for supporting tissue

• US 7,766,926 B2
• Filed: 04/30/2003
• Issued: 08/03/2010
• Est. Priority Date: 04/30/2002
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Vance Products Incorporated (Cook Group Incorporated)
• Inventors: Bosley, Rodney W. Jr., Rosenblatt, Peter L., Ryan, Walter N., Chin, LiKang, Jones, J. Stephen, Patel, Umesh H., Andrews, Marvin O., Fischer, Frank J. Jr.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/427,394
• Publication Number:
  US 20040006353A1
• Time in Patent Office: 2,652 Days
• Field of Search: 606/151, 606/74, 606/76, 606/77, 606/148, 606/191, 600/29, 600/30, 600/37, 24/16.PB, 24/305.R, 24/305.W, 24/305.P, 24/20.TT, 24/17.AP, 24/17.A, 24/22, 24/23.R, 24/23.EE, 206/63.3, 206/441, 623/23.72, D83/94
• US Class Current: 606/151
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

A sling for supporting a urethra in a patient has characteristics for resisting pull-out, roll-over and a combination of both pull-out and roll-over. To facilitate resistance to pull-out, sling material has protuberances or serrations to resist movement once placed in the patient by the surgeon. Improved resistance to roll-over or roll-up is achieved by providing relief on the sling in areas potentially subjected to roll-over forces by endopelvic fascia. The sling may be used on female or male patients, and may be used in conjunction with a wider support portion to support a bladder and a urethra, rather than a urethra alone. The sling may also be used to support other tissues within a patient.

Claims

1. A sling specifically configured for supporting a urethra in a patient with a hammock style arrangement, the sling comprising:

a sterile, medically implantable sling body having a first end portion with a first length and a first width and a second end portion with a second length and a second width;

the sling body having a support portion configured to support a urethra with the support portion disposed below the urethra to support the urethra in a hammock like orientation, with the support portion including a support length and a support width, the support portion being disposed intermediate the first and second end portions;

a first transition segment connecting said first end portion to said support portion, and a second transition segment connecting said second end portion to said support portion, wherein the length of each of the first and second end portions is greater than the length of the support portion and the width of each of the first, second, and support portions is greater than a width of at least a portion of each of the first and second transition segments, and the first and second transition segments are configured to allow the support portion to be substantially flat to support the urethra while at least one of the first and second transition segments or the first and second end portions are compressed;

wherein the end portions, the support portion, and the first and second transition segments are configured for passage through a needle path in soft tissue of the patient.

2. The sling of claim 1, wherein the first end portion and the second end portion are serrated.

3. The sling of claim 2, wherein the serrated portions are from about 10 mm to about 18 mm wide.

4. The sling of claim 1, wherein the transition segments are radiused from about 10 mm to about 25 mm and wherein the sling has a width of from about 6 to 12 mm in the transition segments.

5. The sling of claim 1, further comprising at least one suture about 2 mm from an end of the sling.

6. The sling of claim 1, wherein the support portion is about 2 cm wide and about 1 cm long, and wherein the transition segments are about 2 cm long.

7. The sling of claim 1, wherein the sling is made from at least one layer of vacuum-processed SIS.

8. The sling of claim 1, further comprising an anchor in the first transition segment and an anchor in the second transition segment, the anchor comprising a hole, a penetration, a serration, a protruberance, a barb, a convoluted surface, or a raised portion.

9. The sling of claim 1, wherein the support portion is about 4 cm wide and about 7 cm long, for supporting the urethra and a bladder of the patient.

10. The sling of claim 1, wherein at least one of the first end portion and the second end portion further comprises a protuberance, a button, or a tang for attaching to a needle.

11. The sling of claim 1, wherein at least one of the first end portion and the second end portion is configured as a three-dimensional anchor in the patient.

12. The sling of claim 1, further comprising a plastic sheath for the sling.

13. A combination of the sling of claim 1, at least one needle having a curved portion from about 50 degrees to about 75 degrees, and a handle, wherein the at least one needle is secured to the handle with a transverse set screw.

14. The sling of claim 1, further comprising at least one of an antibacterial treatment, an anti-inflammatory treatment, and a protease inhibitor.

15. The sling of claim 1, wherein the sling retains at least one bio-active component native to source tissue.

16. The sling of claim 15, wherein the at least one bio-active component is a growth factor.

17. The sling of claim 13, wherein the growth factor is selected from the group consisting of FGF-2, TGF-beta, EGF, and PDGF.

18. The sling of claim 1, wherein a relief is provided by material in the first and second transition segments that has been sliced, cut out, windowed or thinned.

19. The sling of claim 1, wherein the support portion and the first and second end portions each comprise a plurality of layers.

20. The sling of claim 1, wherein the support portion comprises a first plurality of layers and the first and second end portions comprise a second plurality of layers, wherein the second plurality is less than the first plurality.

21. The sling of claim 1, wherein the support portion comprises 8 layers of vacuum-processed SIS.

22. The sling of claim 21, wherein at least one of the first end portion or the second end portion comprises a 4-layer laminate of SIS.

23. The sling of claim 1, wherein at least one of the first end portion and the second end portion comprises a 4-layer laminate of SIS.

24. The sling of claim 23, wherein the 4-layer laminate of SIS is lyophilized SIS.

25. A sling for supporting a urethra of a patient, the sling comprising:

a sterile, medically-implantable sling body having a support portion configured for supporting a urethra in a hammock style orientation with a support length and a support width;

the sling body having a first portion and a second portion with respective first and second lengths and first and second widths, each of the first and second portions connected to the support portion, wherein the first portion and second portion have serrations; and

wherein the first and second lengths are greater than the support length;

wherein the first portion and the second portion are each connected to the support portion by a respective transition segment configured to allow the support portion to be substantially flat to support the urethra while at least one of the transition segments or the first and second portions are compressed, wherein the transition segments include a transition width less than the support and first and second widths, wherein at least one of the transition segments defines a relief; and

wherein said first and second portions, support portion and first and second transition segments are configured for passage through a needle path in soft tissue of the patient.

26. The sling of claim 25, wherein at least one transition segment is radiused from about 10 mm to about 25 mm and wherein the sling has a width of from about 6 to 12 mm in the transition segments.

27. The sling of claim 25, further comprising at least one suture about 2 mm from an end of the sling.

28. The sling of claim 25, wherein the support portion is about 2 cm wide and about 1 cm long, and wherein the transition segments are about 2 cm long.

29. The sling of claim 25, wherein the serrated portions are from about 10 mm to about 18 mm wide.

30. The sling of claim 25, wherein the sling is made from at least one layer of submucosa.

31. The sling of claim 25, wherein the sling is made from at least one material selected from the group consisting of synthetic materials, SIS, cross-linked extra-cellular materials, non-cross-linked extra-cellular materials, tissue-engineered materials, polyglycolic acid, collagen, and bioresorbable materials.

32. The sling of claim 25, further comprising an anchor in each said portion of the sling, the anchor selected from the group consisting of a hole, a penetration, a barb, a protuberance, and a raised portion.

33. The sling of claim 25, wherein the support portion is about 4 cm wide and about 7 cm long, for supporting the urethra and a bladder of the patient.

34. The sling of claim 25, wherein at least one of the first portion and the second portion further of a protuberance, a button, and a tang.

35. The sling of claim 25, wherein at least one of the first portion and the second portion is configured as a three-dimensional sling.

36. The sling of claim 25, further comprising a plastic sheath for the sling.

37. A combination of the sling of claim 25, at least one needle having a portion curved from about 50 degrees to about 75 degrees, and a handle, wherein the at least one handle is secured to the needle with a transverse set screw.

38. The sling of claim 25, further comprising at least one of an antibacterial treatment, an anti-inflammatory treatment, and a protease inhibitor.

39. The sling of claim 25, wherein the sling retains at least one bio-active component native to a source tissue.

40. The sling of claim 39, wherein the at least one bio-active component is a growth factor.

41. The sling of claim 40, wherein the growth factor is selected from the group consisting of FGF-2, TGF-beta, EGF, and PDGF.

42. The sling of claim 25, wherein the relief is provided by transition segments that are sliced, cut out, windowed, perforated or thinned.

43. A sling for supporting tissue within a body, the sling comprising:

a sterile, medically-implantable sling body having a support portion configured to support a urethra with a support length, the support portion configured to support the urethra in a hammock style orientation; and

a first portion and a second portion with respective first and second lengths, each of the first and second portions being connected to the support portion by a transition segment, wherein at least one of the transition segments provides an arcuate relief,

wherein the support length is less than each of the first and second lengths, and wherein the transition segments are each configured to allow the support portion to lie substantially flat while one of the transition segments or the first or second portions are compressed; and

wherein said first and second portions, support portion and first and second transition segments are configured for passage through a needle path in soft tissue of the patient.

44. The sling of claim 43, wherein the first portion and the second portion are serrated.

45. The sling of claim 44, wherein the serrations of the first and second portions are from about 10 mm to about 18 mm wide.

46. The sling of claim 43, wherein at least one of the transition segments is radiused from about 10 mm to about 25 mm and wherein the sling has a width of from about 6 to 12 mm in the transition segments.

47. The sling of claim 43, further comprising at least one suture about 2 mm from an end of the sling.

48. The sling of claim 43, wherein the sling is made from at least one layer of vacuum-processed SIS.

49. The sling of claim 43, wherein the sling is made from at least one material selected from the group consisting of synthetic materials, SIS, cross-linked extra-cellular materials, non-cross-linked extra-cellular materials, tissue-engineered materials, polyglycolic acid, collagen, and bioresorbable materials.

50. The sling of claim 43, further comprising at least one of an antiflammatory treatment, an antibacterial treatment, and a protease inhibitor.

51. The sling of claim 43, further comprising anchors in the sling, the anchors selected from the group consisting of serrations, perforations, barbs and raised portions.

52. A sling for specifically configured supporting a urethra, the sling comprising:

a sterile, medically-implantable sling body having a first end portion and a second end portion;

a sling body having a support portion intermediate the first and second end portions for supporting the urethra, the support portion specifically configured to support the urethra in a hammock style orientation;

a sling body having a first transition segment connecting said first end portion to said support portion, and a second transition segment connecting said second end portion to said support portion, wherein at least one of said transition segments provides a relief,

wherein the sling comprises a plurality of layers of extracellular matrix material and wherein the length of the support portion has more layers of the extracellular matrix material than the length of the first and second end portions when the sling is disposed in an elongate flat position; and

wherein the first and second end portions, support portion, and first and second transition segments are configured for passage through a needle path in soft tissue of the patient.

53. The sling of claim 52, wherein the transition segments are radiused from about 10 mm to about 25 mm and wherein the sling has a width of from about 6 to 12 mm in the transition segments.

54. The sling of claim 52, further comprising at least one suture about 2 mm from an end of the sling.

55. The sling of claim 52, further comprising an anchor disposed on each of the first and second end portions, the anchor comprises a serration, a perforation, a penetration, a barb, a convoluted surface, or a raised portion.

56. The sling of claim 52, further comprising an anchor disposed on each of the first and second end portions, the anchor is a serration, and each serration is from about 10 mm to about 18 mm wide.

57. The sling of claim 52, further comprising a plastic sheath for the sling.

58. The sling of claim 52, wherein the support portion comprises eight layers of SIS.

59. A sling specifically configured for supporting a urethra alone or in combination with a bladder of a patient, comprising:

a sterile, medically implantable collagenous body having a first extension, a second extension, and a support portion intermediate the first and second extensions, the support portion specifically configured for supporting a urethra in a hammock style arrangement;

wherein at least a portion of an edge of each of the first and second extensions are serrated;

the body further comprising respective transition regions disposed between the support portion and the respective first and second extension, the transition regions each having a width less than a width of each of the support and first and second extensions, the transition regions configured to allow the support portion to lie substantially flat while at least one of the transition regions or the first and second extensions are compressed;

wherein the first and second extensions, support portion, and transition regions are configured for passage through a needle path in soft tissue of the patient.

60. The sling of claim 59, wherein the collagenous body comprises an extracellular matrix material.

61. The sling of claim 60, wherein the extracellular matrix material comprises submucosa or basement membrane tissue.

62. The sling of claim 60, wherein the collagenous body comprises a plurality of layers of extracellular matrix material.

63. The sling of claim 62 wherein the support portion has a greater number of layers of extracellular matrix material than the first and second extensions.

64. The sling of claim 63, wherein the support portion has eight layers of extracellular matrix material and at least portions of the first and second extensions have four layers of extracellular matrix material.

65. The sling of claim 59, wherein the collagenous body comprises submucosa tissue.

66. The sling of claim 65, wherein the submucosa tissue is small intestinal submucosa tissue.

67. The sling of claim 66, wherein the small intestinal submucosa tissue is porcine.

68. The sling of claim 59, wherein the sling retains at least one bio-active component native to a source tissue.

69. The sling of claim 59, wherein the first extension and the second extension each has an anchor.

70. The sling of claim 69, wherein the anchor comprises one of a convoluted surface, a serration, a protruberance, a penetration, a barb, a hole or a raised portion.