Negative pressure wound closure device

• US 10,405,861 B2
• Filed: 03/29/2016
• Issued: 09/10/2019
• Est. Priority Date: 02/04/2011
• Status: Expired due to Fees

• Current Assignee: University Of Massachusetts
• Original Assignee: University Of Massachusetts
• Inventors: Dunn, Raymond
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): Treyger, Ilya Y
• Application Number:
  US15/083,675
• Publication Number:
  US 20160278773A1
• Time in Patent Office: 1,260 Days
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 2013/00174 possibility of applying pressure
• CPC Class Codes: A61F 2013/00536 for draining or irrigating wounds
• CPC Class Codes: A61F 2013/0054 for deep wounds
• CPC Class Codes: A61F 2013/00544 form or structure
• CPC Class Codes: A61F 2013/00548 net
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 1/90 Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
• CPC Class Codes: A61M 1/916 specially adapted for deep wounds

Abstract

The present invention relates to a negative pressure wound closure system and methods for using such a system. Preferred embodiments of the invention facilitate closure of the wound by preferentially contracting to provide for movement of the tissue. Preferred embodiments can utilize tissue grasping elements to apply a wound closing force to the tissue.

Claims

1. A method of closing a wound, comprising:

placing a sliding surface into a wound opening having opposed wound margins;

inserting a wound closure device into the wound opening over the sliding surface, the wound closure device comprising a wound filler material sized and shaped to fit within the wound opening; and

wherein the filler material comprises a stabilizing structure to enable collapse in at least one first direction and inhibit collapse in at least one second direction, the at least one first direction and the at least one second direction extending in a plane through the opposed wound margins, the stabilizing structure inhibiting collapse in a third direction out of the plane and including a plurality of articulating connected elements such that the stabilizing structure collapses in the at least one first direction.

2. The method of claim 1, wherein the stabilizing structure comprises one or more regions of relatively rigid material surrounded by regions of relatively compressible porous material.

3. The method of claim 2, wherein the filler material has length, width and height dimensions, and the stabilizing structure inhibits collapse in the height dimension.

4. The method of claim 1, further comprising collapsing the filler material in at least one first direction to reapproximate the opposed wound margins of the wound.

5. The method of claim 1, further comprising restricting the collapse of the filler material to a plane defined by the wound margins.

6. The method of claim 1, wherein the stabilizing structure comprises an endoskeleton made from comparatively rigid material.

7. The method of claim 6, wherein the endoskeleton comprises a plurality of spaced-apart rigid members forming a cross-hatched configuration.

8. The method of claim 6, further comprising collapsing the filler material in a width dimension and elongating the filler material in a length dimension.

9. The method of claim 6, further comprising inhibiting collapse of the filler material in the third direction with a plurality of rigid members extending in a height dimension.

10. The method of claim 9, wherein at least a portion of the rigid members extending in the height dimension extend around the periphery of the filler material.

11. The method of claim 6, wherein the endoskeleton comprises a network of interconnected rigid members that can articulate at a plurality of joints such that the interconnected members move with respect to one another during collapse of the filler material.

12. The method of claim 6, further comprising inhibiting a tilting or a collapsing motion of the filler material with truss members.

13. The method of claim 1, wherein the filler material has a smooth bottom surface.

14. The method of claim 13, further comprising removing fluid from the wound through micropores formed in the smooth bottom surface.

15. The method of claim 14, further comprising directing a distribution of vacuum force by varying at least one of the size and pore density of the micropores.

16. The method of claim 1, further comprising directing a distribution of vacuum force by varying at least one of a pore size and a pore density within the filler material.

17. The method of claim 1, further comprising removing portions of the filler material to adjust the size of the wound closure device.

18. The method of claim 17, further comprising removing portions of the filler material along pre-determined cleavage lines.

19. The method of claim 1, wherein the inserting step further comprises inserting the wound closure device that includes a peripheral wall.

20. The method of claim 19, further comprising contacting tissue with the peripheral wall, the wall comprising a porous material.

21. The method of claim 20, further comprising removing fluid through the porous material upon application of negative pressure, the porous material comprising a foam that collapses with the stabilizing structure.

22. The method of claim 1, further comprising removing a portion of the wound filler material prior to insertion into the wound.

23. The method of claim 22, wherein the removing step comprises tearing a portion of the wound filler material.

24. The method of claim 22, wherein the removing step comprises cutting a portion of the wound filler material.

25. The method of claim 1, wherein the removing step comprises removing a portion along a cleavage line.

26. The method of claim 22, wherein the removing step comprises removing one or more portions of the wound filler material using one or more cleavage lines within the wound filler material.

27. The method of claim 1, further comprising attaching the wound filler material to a wound margin with a tissue anchor.

28. The method of claim 1, further comprising applying negative pressure to the wound filler material to cause the collapse of the wound filler material.

29. The method of claim 1, further comprising inhibiting collapse of the wound filler material in a vertical direction with rigid vertically extending elements.

30. The method of claim 1, further comprising positioning the wound filler material in an x-y plane between the wound margins of a wound having an oval or circular shape.

31. The method of claim 1, wherein the articulating connected elements have a cross-hatched shape.

32. The method of claim 22, wherein the stabilizing structure includes cleavage lines or points to remove portions of the stabilizing structure.

33. The method of claim 22, wherein the removing step comprises removing portions of a foam material.

34. The method of claim 1, further comprising forming a foam material that is shaped to extend around the stabilizing structure.

35. The method of claim 1, wherein the inserting step further comprises inserting the wound filler material wherein the articulated connected elements are hinged or bend to collapse in the first direction.

36. The method of claim 1, wherein the inserting step further comprises inserting the wound filler material that is positioned over a porous material.

37. The method of claim 1, further comprising inserting the stabilizing structure in an abdominal wound wherein the stabilizing structure has a porous material around and under the stabilizing structure.

38. A method of closing a wound, comprising:

placing a sliding surface into a wound opening having opposed wound margins;

inserting a wound closure device into the wound opening over the sliding surface, the wound closure device comprising a wound filler material sized and shaped to fit within the wound opening;

wherein the filler material comprises a stabilizing structure to enable collapse in at least one first direction and inhibit collapse in at least one second direction, the at least one first direction and the at least one second direction extending in a plane through the opposed wound margins, the stabilizing structure including a plurality of articulating connected elements such that the stabilizing structure collapses in the at least one first direction.

39. The method of claim 38, wherein the wound filler material collapses by sliding over the sliding surface positioned in an abdominal wound.

40. The method of claim 38, further comprising applying negative pressure to the wound such that fluid is removed through pores formed in the sliding surface and a porous material within the wound closure device.

41. The method of claim 38, wherein the stabilizing structure comprises one or more regions of relatively rigid material surrounded by regions of relatively compressible porous material.

42. The method of claim 41, wherein the filler material has length, width and height dimensions, and the stabilizing structure inhibits collapse in the height dimension.

43. The method of claim 38, wherein the stabilizing structure comprises an endoskeleton made from comparatively rigid material.

44. The method of claim 43, wherein the endoskeleton comprises a plurality of spaced-apart rigid members forming a cross-hatched configuration.

45. The method of claim 43, further comprising collapsing the filler material in a width dimension and elongating the filler material in a length dimension.

46. The method of claim 43, further comprising inhibiting collapse of the filler material in a third direction with a plurality of rigid members extending in a height dimension.

47. The method of claim 46, wherein at least a portion of the rigid members extending in the height dimension extend around the periphery of the filler material.

48. The method of claim 43, wherein the endoskeleton comprises a network of interconnected rigid members that can articulate at a plurality of joints such that the interconnected members move with respect to one another during collapse of the filler material.

49. The method of claim 43, further comprising inhibiting a tilting or a collapsing motion of the filler material with truss members.

50. The method of claim 38, wherein the inserting step further comprises inserting the wound closure device that includes a peripheral wall.

51. The method of claim 50, further comprising contacting tissue with the peripheral wall, the wall comprising a porous material.

52. The method of claim 51, further comprising removing fluid through the porous material upon application of negative pressure, the porous material comprising a foam that collapses with the stabilizing structure.

53. A method of closing a wound, comprising:

inserting a wound closure device into a wound opening having opposed wound margins, the wound closure device comprising a wound filler material sized and shaped to fit within the wound opening, the filler material comprising a stabilizing structure to enable collapse in at least one first direction and inhibit collapse in at least one second direction, the at least one first direction and the at least one second direction extending in a plane through the opposed wound margins, the stabilizing structure including a plurality of articulating connected elements such that the stabilizing structure collapses in the at least one first direction, wherein a foam material is shaped to extend around the stabilizing structure; and

applying negative pressure to the wound closure device.

54. The method of claim 53, wherein the filler material has a smooth bottom surface.

55. The method of claim 54, further comprising removing fluid from the wound through micropores formed in the smooth bottom surface.

56. The method of claim 53, further comprising placing a sliding surface beneath the wound closure device.

57. The method of claim 53, wherein the stabilizing structure comprises one or more regions of relatively rigid material surrounded by regions of relatively compressible porous material.

58. The method of claim 57, wherein the filler material has length, width and height dimensions, and the stabilizing structure inhibits collapse in the height dimension.

59. The method of claim 53, wherein the stabilizing structure comprises an endoskeleton made from comparatively rigid material.

60. The method of claim 59, wherein the endoskeleton comprises a plurality of spaced-apart rigid members forming a cross-hatched configuration.

61. The method of claim 59, further comprising collapsing the filler material in a width dimension and elongating the filler material in a length dimension.

62. The method of claim 59, further comprising inhibiting collapse of the filler material in a third direction with a plurality of rigid members extending in a height dimension.

63. The method of claim 62, wherein at least a portion of the rigid members extending in the height dimension extend around the periphery of the filler material.

64. The method of claim 59, wherein the endoskeleton comprises a network of interconnected rigid members that can articulate at a plurality of joints such that the interconnected members move with respect to one another during collapse of the filler material.

65. The method of claim 59, further comprising inhibiting a tilting or a collapsing motion of the filler material with truss members.

66. The method of claim 53, wherein the inserting step further comprises inserting the wound closure device that includes a peripheral wall.

67. The method of claim 66, further comprising contacting tissue with the peripheral wall, the wall comprising a porous material.

68. The method of claim 67, further comprising removing fluid through the porous material upon application of negative pressure, the porous material comprising a foam that collapses with the stabilizing structure.