Biosynthetic implant for soft tissue repair

• US 10,070,948 B2
• Filed: 12/16/2015
• Issued: 09/11/2018
• Est. Priority Date: 06/27/2008
• Status: Active Grant

• Current Assignee: Sofradim Production
• Original Assignee: Sofradim Production
• Inventors: Bayon, Yves, Gravagna, Philippe, Meneghin, Alfredo
• Primary Examiner(s): Gross, Carson
• Application Number:
  US14/970,655
• Publication Number:
  US 20160100926A1
• Time in Patent Office: 1,000 Days
• Field of Search: 623 2375
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0081 directly machined on the prosthetic surface, e.g. holes, grooves A61F2/30771 takes precedence
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/24 Collagen
• CPC Class Codes: A61L 27/26 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof
• CPC Class Codes: D04B 21/12 characterised by thread material
• CPC Class Codes: D10B 2401/12 biodegradable
• CPC Class Codes: D10B 2403/0112 One smooth surface, e.g. laminated or coated
• CPC Class Codes: D10B 2403/0122 Smooth surfaces, e.g. laminated or coated
• CPC Class Codes: D10B 2509/08 Hernia repair mesh

Abstract

An implant and a process for preparing such an implant are disclosed. The implant includes a porous layer including collagen, a non-porous layer including a collagenic constituent, and a reinforcement component. The non-porous layer is joined to the porous layer and the reinforcement member is embedded into the non-porous layer. The porous layer has a three dimensional density ranging from about 20 mg collagen/cm³ to about 200 mg collagen/cm³.

Claims

1. A process for preparing an implant having a porous layer, a non-porous layer and a reinforcement member comprising:

preparing a composition comprising collagen, using purified fibers of collagen as starting material;

freeze drying the prepared composition to obtain a porous layer,

compressing the porous layer to obtain a three dimensional density ranging from about 20 mg collagen/cm3 to about 200 mg collagen/cm3;

pouring a solution of a collagenic constituent onto a support to obtain a non-porous layer;

applying a reinforcement member on a top surface of the non-porous layer, and

applying the compressed porous layer on the top surface of the non-porous layer, during gelification of the non-porous layer.

2. The process of claim 1, wherein the three dimensional density of the compressed porous layer ranges from about 50 mg collagen/cm3 to about 150 mg collagen/cm3.

3. The process of claim 1, wherein the collagen of the porous layer comprises oxidized collagen.

4. The process of claim 3, wherein the collagen of the porous layer further comprises a collagen crosslinked with a compound selected from glutaraldehyde, hexamethylene diisocyanate (HMDI) and mixtures thereof.

5. The process of claim 3, wherein the collagen of the porous layer further comprises a chitosan.

6. The process of claim 1, wherein the collagenic constituent of the non-porous layer is obtained from purified fibers of collagen used as starting material.

7. The process of claim 1, wherein applying the reinforcement member on the top surface of the non-porous layer further includes pressing the reinforcement member into the solution of the non-porous layer, without causing significant disruption of the portion of the layer of solution in contact with the support, so as to embed the reinforcement member completely within the non-porous layer.

8. The process of claim 1, further comprising applying additional solution of the collagenic constituent after applying the reinforcement member on the top surface of the non-porous layer, in an amount sufficient to cover the reinforcement member, so as to embed the reinforcement member completely within the non-porous layer.

9. The process according to of claim 1, wherein compressing the porous layer reduces the thickness of the porous layer by about 1.2 times to 5 times.

10. The process according to of claim 1, wherein the compressed porous layer has a thickness ranging from about 0.1 cm to 1.5 cm.

11. The process of claim 1, wherein the reinforcement member is a mesh having a weight density less than 100 g/m2.

12. The process of claim 11, wherein the mesh is isoelastic.

13. The process of claim 1, wherein the reinforcement member is a mesh having a weight density greater than 50 g/m2.

14. The process of claim 13, wherein the mesh is asymmetric.

15. The process of claim 13, further comprising coating the mesh with a collagenic coating.

16. The process of claim 15, wherein the collagenic coating comprises collagen crosslinked with a compound selected from glutaraldehyde, hexamethylene diisocyanate (HMDI) and mixtures thereof.

17. The process of claim 15, wherein the collagenic coating comprises a mixture of oxidized collagen and chitosan.

18. The process of claim 1, further comprising adding an additional non-porous layer.

19. The process of claim 18, wherein the additional non-porous layer comprises an additional reinforcement member embedded therein.

20. The process of claim 19, wherein the reinforcement member is coated and the additional reinforcement member is uncoated.

21. A process for preparing an implant having a porous layer, a non-porous layer and a reinforcement member comprising:

freeze drying a composition comprising collagen to obtain a porous layer, compressing the porous layer to obtain a three dimensional density ranging from about 20 mg collagen/cm3 to about 200 mg collagen/cm3;

pouring a solution of a collagenic constituent onto a support to obtain a non-porous layer;

applying a reinforcement member on a top surface of the non-porous layer, and applying the compressed porous layer on the top surface of the non-porous layer, during gelification of the non-porous layer.