Method for preparing neutralized matrix of non-antigenic collagenous material

• US 10,052,400 B2
• Filed: 06/01/2015
• Issued: 08/21/2018
• Est. Priority Date: 05/30/2014
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Jaillon, Amandine, Serrero, Aurelie
• Primary Examiner(s): PACKARD, BENJAMIN J
• Application Number:
  US15/314,741
• Publication Number:
  US 20170189574A1
• Time in Patent Office: 1,177 Days
• CPC Class Codes: A61L 15/325 Collagen
• CPC Class Codes: A61L 2400/04 Materials for stopping bleeding
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials

Abstract

The present invention relates to a method for preparing a neutralized matrix of non-antigenic collagenous material comprising the steps of: —a) preparing an acidic solution of non-antigenic collagenous material, —b) pouring the solution of a) into a mold in order to form a layer, —c) lyophilizing the layer of b) in order to obtain an acidic matrix of non-antigenic collagenous material, d) sterilizing the acidic matrix obtained in c) with ethylene oxide in order to obtain a neutralized matrix of non-antigenic collagenous material. The invention also relates to the matrices obtained and to surgical implants comprising such matrices.

Claims

1. A method for preparing a neutralized matrix of non-antigenic collagenous material comprising:

a) preparing an acidic solution of non-antigenic collagenous material, wherein a pH of said acidic solution is adjusted to a value ranging from about 2.0 to about 4.0,

b) pouring said acidic solution of a) into a mold in order to form a layer,

c) lyophilizing said layer of b) in order to obtain an acidic matrix of non-antigenic collagenous material,

d) sterilizing said acidic matrix obtained in c) with ethylene oxide in order to obtain a neutralized matrix of non-antigenic collagenous material.

2. The method according to claim 1, wherein said acidic solution of step a) is a solution of non-antigenic collagenous material in acidic water, said non-antigenic collagenous material concentration in said acidic solution ranging from 0.1 to 10% by weight, relative to a total weight of said acidic solution.

3. The method according to claim 2, wherein said non-antigenic collagenous material concentration in said acidic solution ranges from 0.5% to 3% by weight, relative to a total weight of said acidic solution.

4. The method according to claim 2, wherein said non-antigenic collagenous material concentration in said acidic solution is 1% by weight, relative to a total weight of said acidic solution.

5. The method according to claim 1, wherein said pH of said acidic solution in a) is adjusted to a value ranging from about 3.0 to about 3.5.

6. The method according to claim 1, wherein said pH of said acidic solution in a) is adjusted to a value of about 3.4.

7. The method according to claim 1, further comprising adding chlorohydric or acetic acid to said acidic solution of step a).

8. The method according to claim 1, wherein said acidic solution of step a) is free of any other polymer than the non-antigenic collagenous material.

9. The method according to claim 1, wherein said lyophilizing of said layer in c) comprises freezing said layer during a time ranging from 3 to 15 hours to form a frozen layer.

10. The method according to claim 9, wherein said frozen layer is primarily dried during a time ranging from 7 to 15 hours.

11. The method according to claim 1, wherein said sterilizing the acidic matrix in d) comprises exposing said acidic matrix to ethylene oxide for a time ranging from about 10 to about 11 hours.

12. The method according to claim 1, wherein said ethylene oxide is injected at a pressure ranging from 70000 Pa to 78000 Pa.

13. A surgical implant comprising at least one neutralized matrix of non-antigenic collagenous material obtained by the method of claim 1.

14. The surgical implant according to claim 13, wherein the at least one neutralized matrix of non-antigenic collagenous material comprises a tensile strength at least two times greater than that of a non-sterilized matrix of non-antigenic collagenous material.

15. The surgical implant according to claim 14, wherein said tensile strength is about three times greater than that of a non-sterilized matrix of non-antigenic collagenous material.

16. The surgical implant according to claim 13, wherein the surgical implant is a hernia repair implant.

17. The surgical implant according to claim 13, wherein the surgical implant is a haemostat.

18. The surgical implant according to claim 13, wherein the at least one neutralized matrix of non-antigenic collagenous material comprises a tensile strength of 0.5 N.