Single plane tissue repair patch

• US 9,820,838 B2
• Filed: 03/11/2013
• Issued: 11/21/2017
• Est. Priority Date: 04/10/2012
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Liu, Xiaodong, Cardinale, Michael
• Primary Examiner(s): Severson, Ryan J
• Application Number:
  US13/793,281
• Publication Number:
  US 20130267971A1
• Time in Patent Office: 1,716 Days
• Field of Search: 606151, 606213, 606215, 623 2372
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2250/0051 differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts

Abstract

A novel single plane tissue repair device such as a patch is disclosed. The device has a base member with an opening therethrough, and a closure member associated with the opening. The mesh has a biaborbable polymeric adhesion barrier attached to the bottom side of the base member about its periphery to form a pocket that is accessible through the opening. The mesh may be used in open surgical procedures for hernia repairs and other repairs of body wall defects.

Claims

1. A single plane tissue defect repair device for repairing a tissue defect in a body wall, comprising:

a substantially flat single plane base member having a top tissue-facing side, a bottom viscera-facing side, an outer periphery and a peripheral edge, wherein the base member is a single mesh layer;

an access opening located in said base member and extending through the base member from the top side to the bottom side;

a closure member associated with said opening adapted to prevent tissue or viscera from moving through the opening, said closure member having a first position such that the access opening is covered and underlying tissue or viscera is prevented from moving through the access opening and a second position such that the access opening is uncovered wherein a surgical instrument can be inserted therethrough; and

,

a polymeric, bioabsorbable adhesion barrier member having a top side, a bottom side, an outer periphery, and a peripheral edge, said adhesion barrier mounted to the base member about their respective outer peripheries such that a pocket is formed between the top side of the adhesion barrier and the bottom side of the base member, said pocket accessible through the opening,

wherein the base member is configured to be affixed to tissue from the bottom viscera-facing side.

2. The tissue repair device of claim 1, wherein the base member additionally comprises a polymeric layer.

3. The device of claim 2, wherein the polymeric layer comprises a nonabsorbable polymer.

4. The device of claim 2, wherein the polymeric layer comprises a bioabsorbable polymer.

5. The device of claim 4, wherein the polymer is selected from the group consisting of silicone, PTFE, polyester, and polypropylene.

6. The device of claim 5, wherein the bioabsorbable polymer is selected from the group consisting of oxidized regenerated cellulose, polydioxanone, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone) and combinations thereof.

7. The device of claim 2, wherein the polymeric layer is an adhesion barrier.

8. The tissue repair device of claim 1, wherein the adhesion barrier member is substantially flat.

9. The tissue repair device of claim 1, wherein the adhesion barrier member is curved.

10. The tissue repair device of claim 1, wherein the adhesion barrier member is shaped.

11. The device of claim 1, wherein the base member comprises a mesh.

12. The device of claim 1, wherein the base member comprises a fabric.

13. The device of claim 12, wherein the fabric is woven.

14. The device of claim 12, wherein the fabric is nonwoven.

15. The device of claim 1, wherein the base member comprises an expanded polymeric film.

16. The device of claim 1, wherein the base member comprises a biocompatible, nondegradable polymer.

17. The device of claim 16, wherein the nondegradable polymer is selected from the group consisting of polypropylene, polyester, nylon, and ultra high molecular weight polyethylene.

18. The device of claim 1, wherein the base member comprises a bioabsorbable polymer.

19. The device of claim 18, wherein the bioabsorbable polymer is selected from the group consisting of polylactides, polyglycolides, polydioxanones, polycaprolactones, copolymers of glycolides and trimethylene carbonate, and copolymers of lactides and trimethylene carbonate, and copolymers and blends thereof.

20. The device of claim 1, wherein the base member comprises a biocompatible nondegradable polymer and a bioabsorbable polymer.

21. The device of claim 1, wherein the opening is a slit.

22. The device of claim 1 wherein the opening is circular.

23. The device of claim 1, wherein the opening is slot shaped.

24. The tissue repair device of claim 1, wherein the closure member comprises opposed closure flap members hingingly mounted about the opening.

25. The tissue repair device of claim 1, wherein the closure member comprises a patch having an outer periphery, wherein a section of the periphery is mounted to the top side of the base member about the opening.

26. The tissue repair device of claim 1, wherein the closure member comprises a surgical suture mounted about the opening.

27. The tissue repair device of claim 1, wherein the closure member comprises a patch having a top side and a bottom side with an engagement member extending from the bottom side, and wherein the base member has a mating engagement member mounted to the top side about the opening, such that the closure patch may be engaged and disengaged from the base member.

28. The tissue repair device of claim 1, wherein the opening comprises a slit having opposed sides and the closure member comprises a surgical suture threaded about the slit adjacent to the sides.

29. The device of claim 1, wherein the opening is centrally located.

30. The device of claim 1, comprising at least two openings and closure members.

31. The device of claim 1, wherein the adhesion barrier member comprises a polymer selected from the group consisting of group consisting of oxidized regenerated cellulose, polydioxanone, poliglecaprone 25 (copolymer of glycolide and epsilon-caprolactone) and combinations thereof.

32. The device of claim 1, wherein the adhesion barrier outer periphery extends beyond the outer peripheral edge of the base member to form a radially extending flange.

33. The device of claim 32, wherein the flange is folded over the peripheral edge of the base member and mounted to the outer periphery of the base member on the top side of the base member.

34. The device of claim 32, wherein the flange is folded under the peripheral edge of the base member and mounted to the outer periphery of the base member on bottom side of the base member.

35. The device of claim 1, wherein the adhesion barrier is mounted to the base member such that the peripheral edges are coextensive.

36. The device of claim 1, wherein the adhesion barrier member is mounted to the periphery of the base member such that it covers at least in part the peripheral edge of the base member.

37. The device of claim 1, wherein the pocket has an outer periphery.

38. A method of performing a body wall defect repair in an open surgical procedure, comprising the steps of:

A. inserting a single plane tissue repair device on an inside layer of a body wall having a tissue defect, wherein the repair device comprises;

a substantially flat single plane base member having a top tissue-facing side, a bottom viscera-facing side, and an outer periphery, wherein the base member is a single mesh layer;

an access opening located in said base member and extending through the base member from the top side to the bottom side;

a closure member associated with said opening adapted to prevent tissue or viscera from moving through the opening, said closure member having a first such that the access opening is covered and underlying tissue or viscera is prevented from moving through the access opening and a second position such that the access opening is uncovered wherein a surgical instrument can be inserted therethrough; and

,

a bioabsorbable adhesion barrier member having a top side, a bottom side and an outer periphery, said adhesion barrier mounted to the base member about their respective outer peripheries such that a pocket having a periphery is formed between the top side of the adhesion barrier and the bottom viscera-facing side of the base member, said pocket accessible through the opening;

B. positioning the device about the defect such that the top tissue-facing side of the base member is adjacent to the inside layer of the body wall;

C. moving the closure member to the second position such that the access opening is uncovered and inserting the end of a surgical fixation instrument through the opening to access the pocket and the bottom viscera-facing side of the base member, and guiding the instrument to the periphery of the pocket, and fixating the base member to the inside layer of the body wall through the bottom viscera-facing side of the base member by applying at least one surgical fastener; and

,

D. manipulating the closure member to the first position to close off and cover the opening such that underlying tissue and viscera are prevented from entering the access opening.

39. The method of claim 38, wherein the tissue defect is a hernia.