Method for producing a prosthesis for reinforcing the abdominal wall

• US 9,499,927 B2
• Filed: 09/25/2013
• Issued: 11/22/2016
• Est. Priority Date: 09/25/2012
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Simons, Damien, Meneghin, Alfredo
• Primary Examiner(s): Worrell, Danny
• Application Number:
  US14/421,222
• Publication Number:
  US 20150218738A1
• Time in Patent Office: 1,154 Days
• US Class Current: 1/1
• 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 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0052 T-shaped
• CPC Class Codes: A61F 2250/0031 made from both resorbable and non-resorbable prosthetic parts, e.g. adjacent parts
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00982 Coating made of collagen
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D06B 1/00 Applying liquids, gases or vapours onto textile materials to effect treatment, e.g. washing, dyeing, bleaching, sizing or impregnating mercerising D06B7/00; solvent-treatment D06B9/00; treatment of selected parts of textile materials D06B11/00; with aid of vibration D06B13/00
• CPC Class Codes: D06C 7/00 Heating or cooling textile fabrics
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2403/0113 One surface including hollow piping or integrated straps, e.g. for inserts or mountings
• CPC Class Codes: D10B 2403/02 Cross-sectional features for three-dimensional features D10B2403/033
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

The invention relates to a method for producing a prosthesis comprising a knitted structure made in one piece, in which method a knit (1) comprising a base sheet (2) and a succession of perpendicular folds (3) is produced in a single knitting step, and said knit (1) is then cut on each side of said folds (3) in order to obtain said knitted structure.

Claims

1. A method for producing a prosthesis for reinforcing an abdominal wall in which an incision has been made, the prosthesis comprising a knitted structure made in one piece, the knitted structure comprising a first portion, which is substantially plane and flexible and is intended to be placed between the abdominal wall and the abdominal cavity, and a second portion, which is substantially plane and flexible and is intended to be placed between two margins of the incision, the second portion extending substantially perpendicularly from one face of the first portion, the method comprising the following steps:

a) producing a knit comprising a base sheet which is substantially plane and elongate and which is equipped in a longitudinal direction with a succession of substantially perpendicular folds to the base sheet, by knitting biocompatible yarns on a warp knitting machine, the biocompatible yarns being distributed on at least three guide bars B1, B2 and B3, the three guide bars operating according to a defined weave repeat recurring as desired along a production length of the knit, each guide bar being supplied with a biocompatible yarn coming from a corresponding warp beam rod at a dedicated run-in appropriate to movement of the guide bar in accordance with the weave repeat, at least bar BI having a variable dedicated run-in value DI, wherein the variable dedicated run-in value DI decreases and tends towards 0 on a part of the weave repeat, the decrease in the variable dedicated run-in value DI on the part of the weave repeat generates a substantially perpendicular fold to the base sheet,

b) cutting from the knit obtained in step a) a knitted structure comprising a part of the base sheet equipped with the substantially perpendicular fold, the part of the base sheet forming the first portion of the prosthesis, and the substantially perpendicular fold forming the second portion of the prosthesis.

2. The method according to claim 1, wherein each of guide bars B2 and B3 has a constant dedicated run-in value D2, D3 over a whole of the weave repeat.

3. The method according to claim 1, wherein the biocompatible yarns comprise bioabsorbable material selected from the group consisting of polylactic acid (PLA), polyglycolic acid (PGA), oxidized cellulose, polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), polyvinyl alcohol (PVA), polyhydroxyalkanoates (PHAs), polyamides, polyesters, copolymers thereof, and mixtures thereof.

4. The method according to claim 1, wherein the biocompatible yarns comprise non-bioabsorbable material selected from the group consisting of polyethylene terephthalate (PET), polyamides, aramids, expanded polytetrafluoroethylene, polyurethane, polyvinyl idene difluoride (PVDF), polybutyl esters, PEEK (polyether ether ketone), polyethylene, polypropylene, and combinations thereof.

5. The method according to claim 1, wherein guide bar B1 is threaded 1 full, 3 empty and the weave repeat of guide bar B1 is according to the following chart according to the standard ISO 11676:

BI;

[(0-0/0-0/1-0/1-1/1-1/1-0)×

I5]-(1-0)/[(0-0)×

45]/0-1/1-0//

wherein the variable run-in value DI decreases and tends towards 0 over the part of the weave repeat [(0-0)×

45].

6. The method according to claim 5, wherein guide bar B2 is threaded 1 full, 1 empty and the weave repeat of guide bar B2 is according to the following chart according to the standard ISO 11676:

B2;

[I-0/2-3/2-I/2-3/I-0/I-2//]×

23,

wherein a dedicated run-in value D2 of guide bar B2 is constant over a whole of the weave repeat.

7. The method according to claim 6, wherein guide bar B3 is threaded 1 full, 1 empty according to the following chart according to the standard ISO 11676:

B3;

[3-4/2-1/2-3/2-1/3-4/3-2//]×

23,

wherein a dedicated run-in value D3 of guide bar B3 is constant over the whole of the weave repeat.

8. The method according to claim 7, wherein the biocompatible yarns distributed on guide bars B1-B3 are monofilament yarns.

9. The method according to claim 8, wherein the monofilament yarn threaded on guide bar BI has a mean diameter greater than a mean diameter of each of the monofilament yarns threaded on guide bars B2 and B3.

10. The method according to claim 8, wherein the mean diameter of the monofilament yarn threaded on guide bar B1 is 150 μ

m and the mean diameter of each of the monofilament yarns threaded on guide bars B2 and B3 is 80 μ

m.

11. The method according to claim 8, wherein the monofilament yarns are made of the same biocompatible material.

12. The method according to claim 11, where the biocompatible material is polylactic acid (PLA).

13. The method according to claim 11, wherein the biocompatible material is polyethylene terephthalate (PET).

14. The method according to claim 1, wherein the substantially perpendicular folds are spaced apart at uniform intervals.

15. The method according to claim 1, wherein the biocompatible yarn of guide bar B1 joins the base sheet to the substantially perpendicular fold without creating any discontinuity or area of weakness.

16. The method according to claim 1, wherein the prosthesis comprises a one-piece, generally T-shaped knitted structure.

17. The method according to claim 1, wherein step b) comprises cutting the knit along the base sheet on each side of the perpendicular fold.

18. The method according to claim 1, further comprising subjecting the knitted structure to one or more additional steps selected from the group consisting of thermosetting, washing, cutting and thermoforming.

19. The method according to claim 1, further comprising step c) which comprises covering a face of the first portion opposite the second portion with an anti-adhesion coating.

20. The method according to claim 19, wherein the anti-adhesion coating is a bioabsorbable film.

21. The method according to claim 20, wherein the bioabsorbable film comprises collagen.