Composite matrix

• US 9,468,708 B2
• Filed: 10/28/2010
• Issued: 10/18/2016
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: Biom'Up
• Original Assignee: Biom'Up
• Inventors: Gagnieu, Christian, Forest, Patricia, Picot, Sylvain
• Primary Examiner(s): Lieb, Jeanette
• Application Number:
  US13/515,742
• Publication Number:
  US 20120253473A1
• Time in Patent Office: 2,182 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/129 containing macromolecular fillers
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body

Abstract

The present invention relates to a composite matrix that includes a reinforcing textile portion having two surfaces coated over at least 90% of the respective surface areas thereof, by means of at least a first layer including at least one resorbable macro-molecule and having a collagen content of between 50 and 100 wt % relative to the total weight of the first layer; the invention also relates to a prosthesis including such a matrix and to a method for preparing said matrix.

Claims

1. A composite matrix comprising a reinforcing textile portion of which both sides, so called first face and second face respectively, are covered over at least 90% of their respective surfaces by at least one first layer comprising at least one resorbable macromolecule, and a collagen content of 50% or more by weight, wherein the first layer of the first face is an antiadhesive layer and the first layer of the second face is a non-porous adhesive layer, the adhesive layer having an adhesive strength sufficient for maintaining said matrix in position on the tissues while enabling said matrix to be removed from the tissues by peeling.

2. The composite matrix of claim 1, wherein the resorbable macromolecule is of biological origin.

3. The composite matrix of claim 2, wherein the resorbable macromolecule of biological origin is selected from:

proteins having a molecular weight greater than or equal to 10,000 Da, or hetero- or homopolymeric polyamino acids having a molecular weight greater than or equal to 1,000 Da,

polysaccharides having at least 10 saccharide units and/or a molecular weight greater than or equal to 1,500 Da, and

nucleic acids having at least 40 nucleotides and/or a molecular weight greater than or equal to 10,000 Da.

4. The composite matrix of claim 1, wherein the resorbable macromolecule is synthetic.

5. The composite matrix of claim 4, wherein the resorbable synthetic macromolecule is selected from:

polylactic acids, polyglycolic acids, a mixture thereof, and

synthetic hetero- or homopolymeric polyamino acids.

6. The composite matrix of claim 1, wherein the first layer comprises at least one compound selected from collagen types I, I+III, III and/or IV, polyamino acids, glycosaminoglycans, native or modified polysaccharides, and mixtures thereof.

7. The composite matrix of claim 1, wherein the first layer comprises acidic fibrous collagen of tendons and acidic fibrous collagen of skin containing variable proportions of acid-soluble collagen and/or atelocollagen, and mixtures thereof.

8. The composite matrix of claim 1, wherein the collagen of the first layer is cross-linked.

9. The composite matrix of claim 8, wherein the collagen of the first layer able to be cross-linked is obtained by coagulation and concomitant cross-linking of collagen in acidic aqueous solution with an aldehyde cross-linking agent that is not reactive at acidic pH by treatment with ammonia gas.

10. The composite matrix of claim 1, wherein the first layer has a dry thickness of 10-200 μ

m.

11. The composite matrix of claim 1, wherein the first layer has a density greater than 1-20 mg/cm².

12. The composite matrix of claim 1, wherein the first layer is covered on one side, by at least one product that improves antiadhesive capacity selected from synthetic triglycerides, collagen, denatured or not, which is optionally grafted by fatty acids.

13. The composite matrix of claim 1, wherein the adhesive layer is favorable to cell colonization.

14. The composite matrix of claim 13, wherein the adhesive layer comprises at least one lowly structured collagen selected from the group consisting of gelatin, denatured collagen, atelocollagen, polylysine and polysaccharides.

16. A method for preparing the matrix of claim 1, comprising at least the following steps:

covering at least 90%, at least 95%, 98%, or the totality of the surface of both sides of a reinforcing textile with a first layer comprising at least one resorbable macromolecule and a collagen content of 50-100% by weight, 75-100% by weight or 90-100% by weight in relation to the total weight of the first layer, and

recovering the matrix thus obtained.

17. The method of claim 16, wherein it comprises the treatment of a first layer comprising acidic collagen and an aldehyde cross-linking agent that is not reactive at acidic pH by ammonia gas.

21. The composite matrix of claim 1, wherein the first layer has a collagen content of 75% to 100% by weight in relation to the total weight of the first layer.

22. The composite matrix of claim 1, wherein the first layer has a collagen content of 90% to 100% by weight in relation to the total weight of the first layer.

23. The composite matrix of claim 4, wherein the resorbable synthetic macromolecule is polylysine.

24. The composite matrix of claim 1, wherein the first layer has a dry thickness of 30-120 μ

m.

25. The composite matrix of claim 1, wherein the first layer has a density greater than 3-12 mg/cm².

26. The composite matrix of claim 1, wherein the first layer is covered on one side by at least one product that improves antiadhesive capacity selected from collagen grafted with stearic acid, succinylated collagen, poly-L-glutamic acid and/or poly-L-aspartic acid.

15. A prosthesis comprising a composite matrix intended for surgery, parietal reinforcement or to replace at least a portion of ligament, wherein the composite matrix comprises a reinforcing textile portion of which both sides, so called first face and second face respectively, are covered over at least 90% of their respective surfaces by at least one first layer comprising at least one resorbable macromolecule, and a collagen content of 50% or more by weight in relation to the total weight of the first layer, wherein the first layer of the first face is an antiadhesive layer and the first layer of the second face is an a non-porous adhesive layer, the adhesive layer having an adhesive strength sufficient for maintaining said matrix in position on the tissues while enabling said matrix to be removed from the tissues by peeling.

18. The prosthesis of claim 15, wherein the resorbable macromolecule is of biological origin and is selected from:

proteins having a molecular weight greater than or equal to 10,000 Da, or hetero-or homopolymeric polyamino acids having a molecular weight greater than or equal to 1,000 Da,

polysaccharides having at least 10 saccharide units and/or a molecular weight greater than or equal to 1,500 Da, and

nucleic acids having at least 40 nucleotides and/or a molecular weight greater than or equal to 10,000 Da.

19. The prosthesis of claim 15, wherein the resorbable macromolecule is synthetic and is selected from:

polylactic acids, polyglycolic acids, a mixture thereof, and

synthetic hetero- or hompolymeric polyamino acids.

20. The prosthesis of claim 15, wherein the first layer comprises at least one compound selected from collagen types I, I+III, III and/or IV, polyamino acids, glycosaminoglycans, native or modified polysaccharides, and mixtures thereof.