Biosynthetic implant for soft tissue repair

• US 9,242,026 B2
• Filed: 06/26/2009
• Issued: 01/26/2016
• 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): TYSON, MELANIE RUANO
• Application Number:
  US12/492,827
• Publication Number:
  US 20100016872A1
• Time in Patent Office: 2,405 Days
• Field of Search: 623/23.72, 623/23.74, 623 1111- 2376, 606/151, 606/213, 600/37
• US Class Current: 1/1
• 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. An implant comprising:

a porous layer comprising collagen;

a non-porous layer comprising a collagenic constituent, the non-porous layer being joined to the porous layer; and

a coated reinforcement member embedded into the non-porous layer,

wherein the porous layer is compressed and has a three dimensional density ranging from about 20 mg collagen/cm³ to about 200 mg collagen/cm³.

2. The implant of claim 1, wherein the porous layer has a three dimensional density ranging from about 50 mg collagen/cm³ to about 150 mg collagen/cm³.

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

4. The implant 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 implant of claim 4, wherein the compound is glutaraldehyde.

6. The implant of claim 4, wherein the compound is hexamethylene diisocyanate.

7. The implant of claim 3, wherein the porous layer further comprises a chitosan.

8. The implant of claim 1, wherein the collagenic constituent of the non-porous layer is oxidized collagen.

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

10. The implant of claim 9, wherein the mesh is isoelastic.

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

12. The implant of claim 11, wherein the mesh is asymmetric.

13. The implant of claim 11, wherein the mesh is coated with a collagen crosslinked with a compound selected from glutaraldehyde, hexamethylene diisocyanate (HMDI) and mixtures thereof.

14. The implant of claim 11, wherein the mesh is coated with a mixture of oxidized collagen and chitosan.

15. The implant of claim 1, further comprising an additional non-porous layer.

16. The implant of claim 15, wherein the additional non-porous layer comprises an additional reinforcement member embedded therein.

17. The implant of claim 1, wherein the porous layer is biodegradable.