Method for preparing an anti-adhesion barrier film

Patent metadata

Field	Value
Publication number	US-10549015-B2
Application number	US-201515503758-A
Country	US
Kind code	B2
Filing date	Sep 23, 2015
Priority date	Sep 24, 2014
Publication date	Feb 4, 2020
Grant date	Feb 4, 2020

Abstract

The present invention relates to a method for preparing a surgical anti-adhesion barrier film comprising the following steps: a°) a first solution, comprising an oxidized collagen is prepared, b) a polyphosphate compound is added to the solution of a) in a quantity so as to obtain a concentration of polyphosphate ranging from 0.007 to 0.7 %, by weight, with respect to the total weight of the solution, c) the pH of the solution obtained in b) is adjusted to about 9 by addition of a base or to about 5.1 by addition of an acid, d) a diluted solution is prepared by adding water to solution of c), e) a first layer of solution obtained in c) is casted on an inert support, f) before complete gelation of the layer obtained in d), a second layer, of diluted solution obtained in d) is applied on top of said first layer and let to gelify, g) the gelified first and second layers are dried to obtain a film. The invention further relates to a film obtainable by such a method and to a surgical implant comprising a prosthetic fabric and such a film.

First claim

The invention claimed is:

1. A method for preparing a surgical anti-adhesion barrier film comprising
a) preparing a first solution comprising oxidized collagen at a concentration ranging from 0.5% to 6% by weight, with respect to a total weight of the first solution,
b) adding a polyphosphate compound to the first solution in a quantity so as to obtain a concentration of polyphosphate ranging from 0.007 to 0.7% by weight, with respect to the total weight of the first solution,
c) adjusting a pH of the first solution obtained in b) to about 9 by adding a base or to about 5.1 by adding an acid,
d) adding water to the first solution of c) to form a diluted solution having a concentration of oxidized collagen ranging from 0.1% to 2.7% by weight, with respect to the diluted solution,
e) casting a first layer of the first solution obtained in c) at a basis weight ranging from 0.03 to 0.4 g/cm 2 ,
f) applying a second layer of the diluted solution obtained in d) on top of the first layer at a basis weight ranging from 0.03 to 0.4 g/cm 2 before complete gelation of the first layer obtained in e), and let gelify,
g) drying the first and second layers to obtain a film.

2. The method of claim 1 , wherein the concentration of oxidized collagen of the first solution of a) is 2.7% by weight, with respect to a total weight of the first solution.

3. The method of claim 1 , wherein the concentration of oxidized collagen of the diluted solution of d) is 1.75% by weight, with respect to the diluted solution.

4. The method of claim 1 , wherein the basis weight of e) is about 0.11 g/cm 2 .

5. The method of claim 1 , wherein the basis weight of f) is about 0.064 g/cm 2 .

6. The method of claim 1 , further comprising adding glycerol to the first solution of step a) at a concentration ranging from 0.1% to 1.5% by weight, with respect to the total weight of the first solution.

7. The method of claim 1 , further comprising adding glycerol to the first solution of step a) at a concentration of about 0.9% by weight, with respect to the total weight of the first solution.

8. The method of claim 1 , further comprising adding polyethylene glycol to the first solution of step a) at a concentration ranging from 0.1% to 1.5% by weight, with respect to the total weight of the first solution.

9. The method of claim 1 , further comprising adding polyethylene glycol to the first solution of step a) at a concentration of about 0.9% by weight, with respect to the total weight of the first solution.

10. The method of claim 1 , further comprising adding glycerol to the first solution of step a) at a concentration ranging from 0.1% to 1.0% by weight, with respect to the total weight of the solution, and adding polyethylene glycol to the first solution of step a) at a concentration ranging from 0.1% to 1.5% by weight, with respect to the total weight of the solution.

11. The method of claim 1 , further comprising adding glycerol to the first solution of step a) at a concentration ranging from 0.1% to 1.0% by weight, with respect to the total weight of the solution, and adding polyethylene glycol to the first solution of step a) at a concentration of about 0.9% by weight, with respect to the total weight of the solution.

12. The method of claim 1 , wherein the polyphosphate compound of b) comprises sodium polyphosphate.

13. The method of claim 12 , wherein the sodium polyphosphate has a degree of polymerization (n) varying from 2 to 100.

14. The method of claim 12 , wherein the sodium polyphosphate has a degree of polymerization (n) varying from 2 to 25.

15. The method of claim 12 , wherein the sodium polyphosphate has a degree of polymerization (n) varying from 5 to 25.

16. The method of claim 1 , wherein adjusting the pH in c) comprises adjusting the pH to about 9 and the method further comprises sterilizing the film obtained in g) by gamma radiation to form a sterilized film.

17. The method of claim 16 , further comprising curing the sterilized film at 40° C. for 48 hours.

18. The method of claim 1 , wherein adjusting the pH in c) comprises adjusting the pH to about 5.1 and the method further comprises sterilizing the film obtained at g) by ethylene oxide to form a sterilized film.

19. The method of claim 18 , further comprising curing the sterilized film at 40° C. for 48 hours.

20. A surgical anti-adhesion barrier film obtained by the method of claim 1 .

21. A surgical implant comprising a biocompatible prosthetic fabric, wherein the prosthetic fabric is at least partially coated with a film obtained according to the method of claim 1 .

Assignees

• Sofradim Production

Inventors

• Prost Nicolas
• Petit Delphine
• Bourges Xavier

Classifications

• A61L2420/08

  Coatings comprising two or more layers · CPC title

• A61F2/0063

  Implantable repair or support meshes, e.g. hernia meshes · CPC title

• B29C41/12

  Spreading-out the material on a substrate {, e.g. on the surface of a liquid} · CPC title

• C08L89/06

  derived from leather or skin {, e.g. gelatin} · CPC title

• A61L31/044 Primary

  Collagen · CPC title