Implant for parastomal hernia

• US 10,368,971 B2
• Filed: 10/05/2015
• Issued: 08/06/2019
• Est. Priority Date: 12/03/2007
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Spinnler, Linda, Lecuivre, Julie, Meneghin, Alfredo, Therin, Michel
• Primary Examiner(s): Yi, Stella K
• Application Number:
  US14/874,499
• Publication Number:
  US 20160022405A1
• Time in Patent Office: 1,401 Days
• 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. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, wherein preparing the two-dimensional knit corresponding to the first part of the porous structure includes knitting at least one yarn using two-guide bars A and B according to the following pattern;

Bar A;

4-4-5-4/4-4-4-3/3-3-2-1/1-1-0-1/1-1-1-2/2-2-3-4//

Bar B;

1-1-0-1/1-1-1-2/2-2-3-4/4-4-5-4/4-4-4-3/3-3-2-1//;

pouring a solution of anti-adhesive material into a mold;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and

drying the porous structure.

2. The method according to claim 1, wherein the step of applying the first part of the porous structure on the solution further comprises substantially completely impregnating the two-dimensional knit with the solution.

3. The method according to claim 1, further comprising the step of applying the solution to a second surface opposite the single surface of the two-dimensional knit corresponding to a first part of the porous structure.

4. The method according to claim 1, wherein the at least one yarn of the two-dimensional knit corresponding to the first part of the porous structure includes a monofilament yarn including polyethylene terephthalate.

5. The method according to claim 1, wherein preparing the one or more three-dimensional knits corresponding to the second part of the porous structure includes knitting at least one yarn using two-guide bars D and E according to the following pattern:

Bar D;

0-1-1-1/1-2-2-2/3-4-4-4/5-4-4-4/4-3-3-3/2-1-1-1//

Bar E;

5-4-4-4/4-3-3-3/2-1-1-1/0-1-1-1/1-2-2-2/3-4-4-4//.

6. The method according to claim 5, wherein the at least one yarn of the one or more three-dimensional knits corresponding to the second part of the porous structure includes a monofilament yarn including polyethylene terephthalate.

7. The method according to claim 5, wherein preparing the implant further includes connecting the two-dimensional knit corresponding to a first part of the porous structure to the one or more three-dimensional knits corresponding to the second part of the porous structure via knitting at least one additional yarn using a single guide bar C according to the following pattern:

Bar C;

1-0-1-0/1-1-1-1/1-1-1-1//.

8. The method according to claim 1, wherein preparing the one or more three-dimensional knits corresponding to the second part of the porous structure includes knitting at least one yarn using two-guide bars D and E′

according to the following pattern;

Bar D;

1-1-1-1/1-2-2-2/3-4-4-4/5-4-4-4/4-3-3-3/2-1-1-1//

Bar E′

;

5-4-3-4/4-3-3-3/2-1-1-1/0-1-2-1/1-2-2-2/3-4-4-4//.

9. The method according to claim 8, wherein the at least one yarn of the second part includes a monofilament yarn including polyethylene terephthalate.

10. The method according to claim 1, wherein preparing the implant includes a textile wherein the two-dimensional knit corresponding to the first part of the porous structure is a central strip separating two lateral strips of the three-dimensional knits corresponding to the second part of the porous structure.

11. The method according to claim 1, wherein preparing the implant includes a textile wherein the two-dimensional knit corresponding to the first part of the porous structure has a first thickness and the one or more three-dimensional knits corresponding to the second part of the porous structure has a second thickness greater than the first thickness.

12. The method according to claim 1, wherein preparing the implant includes a textile wherein the one or more three-dimensional knits corresponding to the second part of the porous structure includes a second 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.

13. The method according to claim 1, wherein pouring the solution of anti-adhesive material into the mold includes a solution which includes materials chosen from among collagens, oxidized celluloses, polyarylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, chitosans, polyglucuronic acids, hyaluronic acids, dextrans, polytetrafluoroethylene, polyethylene glycols, polysiloxanes, polyurethanes, stainless steels and their mixtures.

14. The method according to claim 1, wherein pouring the solution of anti-adhesive material into the mold includes a solution which includes materials chosen from collagens, chitosans, and their mixtures.

15. The method according to claim 1, wherein applying the first part of the porous structure on the solution such that the solution extends past an edge of the porous structure.

16. The method according to claim 1, wherein preparing the implant further includes a textile including at least one orifice formed at about center of the first part of the porous structure to provide a passage for the stoma organ during implantation of the implant.

17. The method according to claim 1, wherein preparing the implant further includes a textile including at least one orifice being offset relative to the center of the implant.

18. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, wherein the one or more three-dimensional knits corresponding to the second part of the porous structure include a second 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;

pouring a solution of anti-adhesive material into a mold;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and

drying the porous structure.

19. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure;

pouring a solution of anti-adhesive material into a mold, the solution including materials selected from the group consisting of collagens, oxidized celluloses, polyarylates, trimethylene carbonates, caprolactones, dioxanones, glycolic acid, lactic acid, glycolides, lactides, polysaccharides, chitosans, polyglucuronic acids, hylauronic acids, dextrans, polytetrafluoroethylene, polyethylene glycols, polysiloxanes, polyurethanes, stainless steels and their mixtures;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and

drying the porous structure.

20. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure;

pouring a solution of anti-adhesive material into a mold, the solution including materials selected from the group consisting of collagen, chitosan, and their mixtures;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and

drying the porous structure.

21. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a two-dimensional knit corresponding to a first part of the porous structure and one or more three-dimensional knits corresponding to a second part of the porous structure, the textile including at least one orifice formed at about center of the first part of the porous structure to provide a passage for the stoma organ during implantation of the implant;

pouring a solution of anti-adhesive material into a mold;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the one or more three-dimensional knits; and

drying the porous structure.

22. A method of forming 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:

preparing an implant having a porous structure composed of a textile having a central strip of a two-dimensional knit corresponding to a first part of the porous structure separating two lateral strips of three-dimensional knits corresponding to a second part of the porous structure;

pouring a solution of anti-adhesive material into a mold;

applying the first part and the second part of the porous structure on the solution such that the solution at least superficially impregnates a single surface of the two-dimensional knit and the three-dimensional knits; and

drying the porous structure.