Anti-adhesion device

• US 20050261782A1
• Filed: 05/20/2004
• Published: 11/24/2005
• Est. Priority Date: 05/20/2004
• Status: Active Grant

• Current Assignee: DSM IP Assets BV (DSM-Firmenich AG)
• Original Assignee: Kensey Nash Corporation (DSM-Firmenich AG)
• Inventors: Hoganson, David M.
• Granted Patent: US 7,758,654 B2
• Time in Patent Office: Days
• US Class Current: 623/23.740
• CPC Class Codes: A61B 17/085 with adhesive layer
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

The construct described herein allows opposing tissues to form adhesions with either side of the construct, as part of the natural healing process. The construct however is multi-layered, wherein the space between the layers provides the protection from unwanted adhesions forming between and bonding separate tissues. In one embodiment, this space between layers of the construct may be developed spontaneously, that is the multiple layers are released by design after a finite time and the opposing tissues are free to move independent of each other, free of adhesions.

Claims

1. An implantable device for the prevention of adhesions comprising a plurality of layers, wherein said plurality of layers comprises at least an anterior and posterior layer, said anterior and posterior layers each having an outer and inner surface, said outer surfaces serving to promote adhesion to tissue and said inner surfaces serving to resist adhesion to tissue, said plurality of layers having at least one releasable attachment means arranged between said layers, said releasable attachment means being arranged to attach said layers together, wherein after implantation, said releasable attachment releases, whereupon said plurality of layers are releasably separate.

2. The device of claim 1 wherein at least a portion of at least one of said layers comprises a plurality of pores.

3. The device of claim 1 wherein the inner surfaces of said anterior and posterior layers are substantially non-porous.

4. The device of claim 3 wherein the outer surfaces of said anterior and posterior layers are porous.

5. The device of claim 1 further comprising at least one additive component.

6. The device of claim 5 wherein said additive component comprises at least one of biologically active agent, carrier material, fibrous material, particulate material, plasticizer, and combinations thereof.

7. The device of claim 2 further comprising at least one additive component.

8. The device of claim 7 wherein said additive component comprises at least one of biologically active agent, carrier material, fibrous materials, particulate materials, plasticizers, and combinations thereof.

9. The device of claim 7 wherein said additive component is contained within said plurality of pores.

10. The device of claim 5 wherein said additive component comprises a biologically active agent, said biologically active agent being arranged to be delivered by the device through a period of finite duration.

11. The device of claim 10 wherein said biologically active agent is released at a controlled rate.

13. The device of claim 1 further comprising at least one intervening layer of material between said anterior and posterior layers, said intervening layer being arranged to reduce adhesion or friction between said anterior and posterior layers.

14. The device of claim 1, wherein said releasable attachment means comprises at least one of sutures, staples, clips, magnets, static bonds, physically interlocking components, adhesives, salts, carbohydrates, gelatins, hydrogels and combinations thereof.

15. The device of claim 1, wherein said releasable attachment means is resorbable.

16. The device of claim 15, wherein said plurality of layers are resorbable.

17. The device of claim 16 wherein said releasable attachment means is resorbed faster than said layers.

18. The device of claim 1 wherein said layers are attached by said releasable attachment means through at least one point.

19. The device of claim 1 wherein said layers are attached by said releasable attachment means along at least one edge.

20. The device of claim 3 wherein said substantially non-porous layers are impermeable to fluid.

21. The device of claim 1 further comprising a locating means.

22. The device of claim 1 further comprising securing means being arranged to secure said device to tissue.

23. The device of claim 22 wherein securing means comprises at least one loop arranged on said outer surfaces of the device.

24. The device of claim 23 wherein said securing means comprises an adhesive applied to said device.

50. The device of claim 22, wherein said securing means comprises at least one of tabs, magnets and staples.

51. The device of claim 21, wherein said locating means comprises at least one locating limb.

52. The device of claim 51, wherein said locating limb may be attached to at least one of said outer surface and said inner surface.

53. The device of claim 51, wherein a single locating limb is attached to at least one of said outer surface and said inner surface at multiple locations.

54. The device of claim 1, wherein at least one layer comprises a non-resorbable material.

55. The device of claim 1, wherein at least one layer comprises a resorbable polymer material.

57. The device of claim 7, wherein said additive component is located in at least one of said pores and said at least one layer.

58. The device of claim 7, wherein said additive component comprises at least one of an adhesion promoter material and an adhesion retarding material.

59. The device of claim 7, wherein said additive component comprises at least one structural agent.

60. The device of claim 1, arranged to promote local adhesions of at least two tissues to one another.

61. The device of claim 1, further comprising at least one reinforcing material.

62. The device of claim 61, wherein said reinforcing material is arranged as a layer.

64. The device of claim 1, as substantially shown and described.

12. The device of clams 5, wherein the additive component affects the formation of adhesion between tissue and said device.

25. An implantable device for the prevention of adhesions comprising a plurality of layers, wherein said plurality of layers comprises at least an anterior layer and a posterior layer, said anterior and posterior layers each having an outer and inner surface, each of said anterior and posterior layers having a porosity comprising a plurality of pores, said porosity varying across the thickness of each of said anterior and posterior layers.

26. The device of claim 25, wherein said varying porosity comprises a gradient, wherein said gradient comprises greater porosity towards said outer surface and reduced porosity towards said inner surface.

27. The device of claim 25, further comprising at least one additive component.

28. The device of claim 27 wherein said additive component comprises at least one of biologically active agent, carrier material, fibrous material, particulate material, plasticizer, and combinations thereof.

29. The device of claim 27, wherein said additive component is contained within said plurality of pores.

30. The device of claim 27, wherein said additive component comprises a biologically active agent, said biologically active agent being arranged to be delivered by the device through a period of finite duration.

31. The device of claim 30, wherein said biologically active agent is released at a controlled rate.

32. The device of claim 27, wherein said additive component affects the formation of adhesion between tissue and said device.

33. The device of claim 25 further comprising at least one intervening layer of material located between said layers, said intervening layer being arranged to reduce adhesion or friction between said layers.

34. The device of claim 25 further comprising a releasable attachment means, said releasable attachment means being arranged so as to attach said layers together.

35. The device of claim 34, wherein said releasable attachment means comprises at least one of sutures, staples, clips, magnets, static bonds, physically interlocking components, adhesives, salts, carbohydrates, gelatins, hydrogels and combinations thereof.

36. The device of claim 34 wherein upon implantation, said releasable attachment means releases, whereupon said layers are releasably separated.

37. The device of claim 34 wherein said releasable attachment means is resorbable.

38. The device of claim 37, wherein said plurality of layers are resorbable.

39. The device of claim 38 wherein said releasable attachment means is resorbed faster than said layers.

40. The device of claim 34, wherein said layers are attached by said releasable attachment means at one or more points.

41. The device of claim 40, wherein said layers are attached along at least one edge.

42. The device of claim 41, wherein said layers are attached along all the edges thereby forming a substantially sealed space.

43. The device of claim 25 further comprising a locating means.

44. The device of claim 25 further comprising securing means arranged to secure said device to tissue.

45. The device of claim 44 wherein said securing means comprises at least one loop arranged on a surface of the device.

46. The device of claim 44 wherein said securing means comprises an adhesive applied to said device.

56. The device of claim 25, wherein said varying porosity comprises pores varying in at least one of size and number.

47. A method for preventing the formation of adhesions following a surgical procedure comprising the step of placing a device between two tissues, said device comprising a plurality of layers, wherein said plurality of layers comprises at least an anterior layer and a posterior layer, said anterior and posterior layers each having an outer and inner surface, said outer surfaces serving to resist adhesion to tissue, said plurality of layers having at least one releasable attachment means arranged between said layers and attaching said layers together, wherein after implantation, said releasable attachment releases, whereupon said plurality of layers are releasably separate.

48. The method of claim 47 further comprising the step of securing said device to said tissue.

49. The method of claim 48 wherein said device is secured to the tissue with a securing means, said securing means comprising at least one of adhesive, suture, staple, and combinations thereof.

63. An implantable device for the prevention of adhesions comprising a plurality of layers, wherein said plurality of layers comprises at least an anterior layer and a posterior layer, said anterior and posterior layers each having an outer and inner surface, said outer surfaces serving to promote adhesion to tissue and said inner surfaces serving to resist adhesion to tissue, at least a portion of said inner surfaces opposing each other, said plurality of layers having at least one releasable attachment means arranged between said layers, said releasable attachment means being arranged to attach said layers together, wherein after implantation, said releasable attachment releases, whereupon said plurality of layers are no longer attached to one another.