Medical device

• US 20050234291A1
• Filed: 03/30/2005
• Published: 10/20/2005
• Est. Priority Date: 03/30/2004
• Status: Abandoned Application

• Current Assignee: Proxy Biomedical Limited
• Original Assignee: Proxy Biomedical Limited
• Inventors: Gingras, Peter
• Application Number:
  US11/094,643
• Publication Number:
  US 20050234291A1
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 13/47209 having only interlabial part, i.e. with no extralabial parts
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0023 differing in porosity
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2509/08 Hernia repair mesh
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

A tubular non-woven soft tissue implant (30) has cell patterns (32). The cell pattern (32) has a continuous circumferential construction with atraumatic edges (34) and a tubular centre (36). The implant (30) is suitable for stabilising and/or supporting body tissue for example to treat urinary incontinence and/or pelvic floor prolapse.

Claims

1. An implant for treating urinary incontinence and/or pelvic floor prolapse comprising an elongate tubular sling structure for stabilising and/or supporting body tissue.

2. An implant as claimed in claim 1 wherein at least part of the sling structure has a substantially reduced elasticity.

3. An implant as claimed in claim 2 wherein the elasticity varies along the sling structure.

4. An implant as claimed in claim 3 wherein the sling structure comprises a first portion and a second portion, the first portion having a reduced elasticity relative to the second portion.

5. An implant as claimed in claim 4 wherein the first portion is configured to engage a urethra of a patient.

6. An implant as claimed in claim 4 wherein the second portion is configured to be positioned in use spaced from a site of interest.

7. An implant as claimed in claim 4 wherein the first portion comprises a first element and the second portion comprises a second element, the first element being separate from the second element.

8. An implant as claimed in claim 7 wherein the first element is attached to the second element at an end of the second element.

9. An implant as claimed in claim 8 wherein the first element is attached to the second element at each end of the second element.

10. An implant as claimed in claim 9 wherein the first element is detached from the second element along the length of the second element between the ends.

11. An implant as claimed in claim 3 wherein the elasticity varies along the length of the sling structure.

12. An implant as claimed in claim 1 wherein the sling structure is configured to be attached to body tissue.

13. An implant as claimed in claim 12 wherein the sling structure is configured to facilitate coupling of an attachment element to the sling structure.

14. An implant as claimed in claim 13 wherein the sling structure comprises one or more attachment openings for receiving an attachment element.

15. An implant as claimed in claim 12 wherein the sling structure is shaped for attachment of the sling structure to body tissue.

16. An implant as claimed in claim 15 wherein the sling structure comprises one or more engagement formations for attaching the sling structure to body tissue.

17. An implant as claimed in claim 16 wherein the sling structure comprises a plurality of engagement formations arranged in a wave-like pattern.

18. An implant as claimed in claim 16 wherein the sling structure comprises a plurality of engagement formations arranged in a dimple-like pattern.

19. An implant as claimed in claim 16 wherein the diameter of the sling structure varies along the length of the sling structure.

20. An implant as claimed in claim 19 wherein the diameter of the sling structure varies in a step-wise manner along the length of the sling structure.

21. An implant as claimed in claim 16 wherein the engagement formation comprises a recess for receiving a portion of body tissue.

22. An implant as claimed in claim 21 wherein the recess is configured to receive at least part of a urethra.

23. An implant as claimed in claim 12 wherein the sling structure comprises an attachment portion configured to be attached to body tissue and a detached portion configured to remain detached from body tissue.

24. An implant as claimed in claim 12 wherein the attachment portion has a relatively high co-efficient of friction.

25. An implant as claimed in claim 12 wherein the detached portion has a relatively low co-efficient of friction.

26. An implant as claimed in claim 1 wherein the external surface of the sling structure, which is contactable with body tissue, is substantially atraumatic.

27. An implant as claimed in claim 1 wherein the sling structure is of a laminate configuration.

28. An implant as claimed claim 27 wherein the sling structure comprises a first layer and a second layer.

29. An implant as claimed in claim 28 wherein the rate of absorption of the first layer is greater than the rate of absorption of the second layer.

30. An implant as claimed in claim 28 wherein the first layer is attached to the second layer.

31. An implant as claimed in claim 1 wherein the implant comprises a reinforcement for the sling structure.

32. An implant as claimed in claim 31 wherein the sling structure is of a composite configuration.

33. An implant as claimed in claim 32 wherein the implant comprises one or more fibres to reinforce the sling structure.

34. An implant as claimed in claim 1 wherein the sling structure is configured to facilitate tissue ingrowth and/or cellular infiltration.

40. An implant as claimed in claim 1 wherein the sling structure comprises a non-woven biocompatible material.

41. An implant as claimed in claim 40 wherein the non-woven biocompatible material comprises a film material.

42. An implant as claimed in claim 1 wherein the sling structure comprises one or more biocompatible fibres.

43. An implant as claimed in claim 42 wherein the fibre comprises a monofilament fibre.

44. An implant as claimed in claim 1 wherein the sling structure comprises an absorbable biocompatible material.

45. An implant as claimed in claim 1 wherein the sling structure comprises a non-absorbable biocompatible material.

46. An implant as claimed in claim 1 wherein the sling structure comprises a tissue-based biocompatible material.

47. An implant as claimed in claim 1 wherein at least some of the mechanical properties of the mesh are substantially omnidirectional.

48. An implant as claimed in claim 47 wherein the elasticity of the mesh is substantially omnidirectional.

49. An implant as claimed in claim 1 wherein the implant is configured to distribute the stabilising and/or supporting force.

50. An implant as claimed in claim 49 wherein the sling structure is shaped to distribute the stabilising and/or supporting force exerted.

51. An implant as claimed in claim 1 wherein the sling structure is movable from a delivery configuration to a deployment configuration.

52. An implant as claimed in claim 51 wherein the delivery configuration is of a lower-profile than the deployment configuration.

53. An implant as claimed in claim 51 wherein the implant comprises a support to support the sling structure in the deployment configuration.

54. An implant as claimed in claim 1 wherein the implant comprises an indicator to determine the magnitude and/or direction of a force applied to the sling structure.

55. An implant as claimed in claim 54 wherein the indicator is configured to determine by visual inspection the magnitude and/or direction of a force applied to the sling structure.

56. An implant as claimed in claim 54 wherein the indicator comprises an instrument to measure the magnitude and/or direction of a force applied.

68. A medical instrument for delivering an implant as claimed in claim 1 to a desired site and for deploying the implant at the desired site.

69. A method of treating urinary incontinence and/or pelvic floor prolapse comprising the steps of:

—

delivering the implant as claimed in claim 1 to a desired site; and

deploying the implant at the desired site.

35. An implant as claimed in claim 35 wherein the sling structure is at least partially porous.

36. An implant as claimed in claim 35 wherein the sling structure comprises a plurality of pores arranged into a cell pattern.

37. An implant as claimed in claim 36 wherein the cell pattern varies across the sling structure.

38. An implant as claimed in claim 37 wherein the pore size remains substantially constant across the sling structure, and the extent of material extending between adjacent pores varies across the sling structure.

39. An implant as claimed in claim 38 wherein the density of the cell pattern varies along the sling structure.

57. An implant for treating urinary incontinence and/or pelvic floor prolapse comprising a structure for stabilising and/or supporting body tissue, at least part of the structure having a substantially reduced elasticity.

58. An implant as claimed in claim 57 wherein the structure is substantially planar.

59. An implant for treating urinary incontinence and/or pelvic floor prolapse comprising a structure for stabilising and/or supporting body tissue, the structure being shaped for attachment of the structure to body tissue.

60. An implant for treating urinary incontinence and/or pelvic floor prolapse comprising a structure for stabilising and/or supporting body tissue, the structure comprising a non-woven biocompatible material.

61. An implant for treating urinary incontinence and/or pelvic floor prolapse comprising a structure for stabilising and/or supporting body tissue, the structure being shaped to distribute the stabilising and/or supporting force exerted.

62. A method of producing an implant for treating urinary incontinence and/or pelvic floor prolapse, the method comprising the step of forming a structure for stabilising and/or supporting body tissue.

63. A method as claimed in claim 62 wherein the implant comprises an implant as claimed in 1.

64. A method as claimed in claim 62 wherein the method comprises the step of treating the structure to reduce the elasticity of at least part of the structure.

65. A method as claimed in claim 64 wherein a first part of the structure is treated to reduce the elasticity of the first part, and a second part of the structure remains untreated without any reduction in the elasticity of the second part.

66. A method as claimed in claim 62 wherein the method comprises the step of treating the structure to make at least some of the mechanical properties of the structure substantially omnidirectional.

67. A method as claimed in claim 66 wherein the mesh is stretched in a first direction while holding the mesh in a second direction perpendicular to the first direction.

70. A soft tissue implant comprising a non-woven biocompatible material, the implant being at least partially porous with a plurality of pores arranged into a cell pattern, the cell pattern varying across the implant.

71. A soft tissue implant comprising a non-woven biocompatible material, the mechanical properties of the implant varying across the implant.

72. A soft tissue implant comprising a non-woven biocompatible material, the implant being shaped for attachment of the implant to body tissue.

73. A soft tissue implant comprising a non-woven biocompatible material, the implant being shaped to distribute the force exerted by the implant on body tissue.

74. A soft tissue implant comprising a non-woven biocompatible material, and a reinforcement to reinforce an edge region of the material.

75. An implant as claimed in claim 74 wherein the reinforcement is configured to increase the strength of the edge region.

76. An implant as claimed in claim 74 wherein the reinforcement comprises an inelastic element.