COMPOSITE MATRIX

• US 20120253473A1
• Filed: 10/28/2010
• Published: 10/04/2012
• Est. Priority Date: 12/31/2009
• Status: Active Grant

• Current Assignee: Biom'Up
• Original Assignee: Biom'Up
• Inventors: Gagnieu, Christian, Forest, Patricia, Picot, Sylvain
• Granted Patent: US 9,468,708 B2
• Time in Patent Office: Days
• US Class Current: 623/23.72
• 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 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% to 100% by weight, notably 75% to 100% by weight, and in particular 90% to 100% by weight in relation to the total weight of the first layer.

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

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

nucleic acids, in particular 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 polyamino acids, notably hetero- or homopolymeric, such as polylysine.

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 in particular 30-120 μ

m.

11. The composite matrix of claim 1, wherein the first layer has a density greater than 1-20 mg/cm², and in particular 3-12 mg/cm².

12. The composite matrix of claim 1, wherein the first layer is covered, notably on one side, by at least one product that improves antiadhesive capacity selected from synthetic triglycerides, collagen, denatured or not, grafted by fatty acids, in particular by collagen grafted with stearic acid, succinylated collagen, poly-L-glutamic acid and/or poly-L-aspartic acid.

13. The composite matrix of claim 1, comprising a first side covered with a first antiadhesive layer and a second side covered with an adhesive layer, notably favorable to cell colonization.

14. The composite matrix of claim 13, wherein the adhesive layer comprises lowly structured collagen, such as gelatin, denatured collagen, atelocollagen, optionally weakly cross-linked, polylysine and/or polysaccharides, such as chitosan.

15. A prosthesis comprising a composite matrix intended for surgery and in particular for parietal reinforcement or to replace at least a portion of ligament, wherein the composite matrix comprises a reinforcing textile portion of which both sides 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% to 100% by weight, notably 75% to 100% by weight, and in particular 90% to 100% by weight in relation to the total weight of the first layer.

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

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

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

nucleic acids, in particular 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 polyamino acids, notably hetero- or homopolymeric, such as polylysine.

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.

16. A method for preparing a matrix comprising at least the following steps:

covering at least 90%, notably at least 95%, in particular at least 98%, even 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, notably 75-100% by weight, and in particular 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.