Implant for parastomal hernia

• US 9,308,068 B2
• Filed: 12/02/2008
• Issued: 04/12/2016
• Est. Priority Date: 12/03/2007
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Lecuivre, Julie, Meneghin, Alfredo, Therin, Michel, Spinnler, Linda
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US12/326,303
• Publication Number:
  US 20090192532A1
• Time in Patent Office: 2,688 Days
• Field of Search: 606/151, 606/193, 606/194, 623 2372- 2374
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 5/445 Colostomy, ileostomy or urethrostomy devices A61F5/441, A61F5/442, A61F5/443 take precedence
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2403/0213 with apertures, e.g. with one or more mesh fabric plies
• CPC Class Codes: D10B 2501/0632 of the touch-and-close type
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

An implant for the prevention or treatment of a hernia in the proximity of an organ stoma formed in an abdominal wall includes a porous structure having a surface intended to face the abdominal cavity covered by a first film of anti-adhesive material. The porous structure includes a first part intended to be in contact with a stoma organ and having a first thickness, and a second part having a second thickness greater than the first thickness, the first part including a surface intended to face the abdominal wall covered by a second film of anti-adhesive material.

Claims

1. An implant for the prevention or treatment of a hernia formed in an abdominal wall in the proximity of a stoma of an organ comprising:

a porous structure including a surface intended to face an abdominal cavity covered by a first film of anti-adhesive material, the porous structure comprising a first part intended to be in contact with a stoma organ and having a first thickness, and a second part having a second thickness greater than the first thickness, the first part and the second part including a surface intended to face an abdominal wall, the surface of the first part being covered by a second film of anti-adhesive material, and the surface of the second part having an open surface.

2. The implant according to claim 1, wherein the porous structure comprises a sponge, a fibrous matrix, or a combination of a sponge and of a fibrous matrix.

3. The implant according to claim 2, wherein the porous structure comprises a textile.

4. The implant according to claim 3, wherein the first part of the porous structure is composed of yarns made of biocompatible materials, bioabsorbable materials, non-bioabsorbable materials and their mixtures.

5. The implant according to claim 4, wherein the bioabsorbable materials are chosen from among polylactic acid (PLA), polysaccharides, polycaprolactones (PCL), polydioxanones (PDO), trimethylene carbonates (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHA), polyamides, polyethers, oxidized cellulose, polyglycolic acid (PGA), copolymers of these materials and their mixtures.

6. The implant according to claim 4, wherein the non-bioabsorbable materials are chosen from among polypropylenes, polyesters such as polyethylene terephthalates, polyamides, polyvinylidene fluoride, and their mixtures.

7. The implant according to claim 4, wherein the yarns forming the first part of the porous structure are chosen from among monofilament yarns, multifilament yarns and their combinations.

8. The implant according to claim 7, wherein the yarns forming the first part of the porous structure are monofilament yarns.

9. The implant according to claim 8, wherein the monofilament yarns have a diameter of from about 0.06 to about 0.15 mm.

10. The implant according to claim 8, wherein the monofilament yarns are of polyethylene terephthalate.

11. The implant according to claim 3, wherein the second part of the porous structure is composed of yarns made of biocompatible materials, bioabsorbable materials, non-bioabsorbable materials and their mixtures.

12. The implant according to claim 11, wherein the bioabsorbable materials are chosen from among polylactic acid (PLA), polysaccharides, polycaprolactones (PCL), polydioxanones (PDO), trimethylene carbonates (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHA), polyamides, polyethers, oxidized cellulose, polyglycolic acid (PGA), copolymers of these materials and their mixtures.

13. The implant according to claim 11, wherein the non-bioabsorbable materials are chosen from among polypropylenes, polyesters such as polyethylene terephthalates, polyamides, polyvinylidene fluoride, and their mixtures.

14. The implant according to claim 11, wherein the yarns forming the second part of the porous structure are chosen from among monofilament yarns, multifilament yarns and their combinations.

15. The implant according to claim 14, wherein the yarns forming the second part of the porous structure are monofilament yarns.

16. The implant according to claim 15, wherein the monofilament yarns have a diameter of from about 0.06 to about 0.15 mm.

17. The implant according to claim 15, wherein the monofilament yarns are of polyethylene terephthalate.

18. The implant according to claim 1, wherein the porous structure has pores with dimensions of from approximately 0.1 to approximately 3 mm.

19. The implant according to claim 1, wherein the first thickness is from approximately 0.15 to approximately 0.50 mm.

20. The implant according to claim 1, wherein the first part of the porous structure is a textile in the form of a two-dimensional knit.

21. The implant according to claim 20, wherein the second part of the porous structure is a textile in the form of a three-dimensional knit.

22. The implant according to claim 21, wherein the two-dimensional knit and the three-dimensional knit are joined together by at least one seam.

23. The implant according to claim 21, wherein the two-dimensional knit and the three-dimensional knit are knitted together on the same knitting machine and constitute a textile made in one piece.

24. The implant according to claim 1, wherein the second thickness is from about 0.40 to about 3.00 mm.

25. The implant according to claim 1, wherein the second part of the porous structure includes a surface intended to face the abdominal wall having elements chosen from loops, barbs, hooks, threads, or clips for fastening the second part to the abdominal wall.

26. The implant according to claim 25, wherein the elements are chosen from among loops, barbs, and their mixtures.

27. The implant according to claim 1, wherein the anti-adhesive material of the first and/or second film is chosen from among bioabsorbable materials, non-bioabsorbable materials and their mixtures.

28. The implant according to claim 27, wherein the bioabsorbable materials are chosen from among collagens, oxidized celluloses, polyarylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, for example chitosans, polyglucuronic acids, hylauronic acids, dextrans and their mixtures.

29. The implant according to claim 27, wherein the non-bioabsorbable materials are chosen from among polytetrafluoroethylene, polyethylene glycols, polysiloxanes, polyurethanes, stainless steels, derivatives of precious metals and their mixtures.

30. The implant according to claim 29, wherein the bioabsorbable material is a hydrophilic material chosen from the group consisting of collagens, polysaccharides and their mixtures.

31. The implant according to claim 1, wherein the first film of anti-adhesive material extends past the edges of the porous structure.

32. The implant according to claim 31, wherein the first film of anti-adhesive material extends past the edges of the porous structure by about 3 to about 10 millimeters.

33. The implant according to claim 1, wherein the first film and the second film form a single film, the first film completely coating the first part of the porous structure and thus covering the first part of the porous structure both on the surface intended to face the abdominal cavity and also on the surface intended to face the abdominal wall.

34. The implant according to claim 1, wherein the porous structure has a generally elongate shape.

35. The implant according to claim 1, wherein the porous structure has a generally round shape.

36. The implant according to claim 1, wherein the first part of the porous structure has a central strip.

37. The implant according to claim 36, further comprising at least one orifice formed at about centre of the first part of the porous structure to provide a passage for the stoma organ during implantation of the implant.

38. The implant according to claim 36, further comprising at least one orifice formed within the first part of the porous structure, the orifice being offset relative to the centre of the implant.

39. The implant according to claim 1, wherein the first part of the porous structure has a disc shape.

40. A method of treating or preventing a hernia in the proximity of a stoma formed in the skin comprising:

implanting an implant according to claim 1 in the proximity of a stoma, the porous structure including a surface intended to face an abdominal cavity covered by a first film of anti-adhesive material, the porous structure comprising a first part intended to be in contact with a stoma organ and having a first thickness, and a second part having a second thickness greater than the first thickness, the first part including a surface intended to face an abdominal wall covered by a second film of anti-adhesive material.