Biocompatible scaffold for ligament or tendon repair

• US 7,824,701 B2
• Filed: 02/25/2003
• Issued: 11/02/2010
• Est. Priority Date: 10/18/2002
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Hwang, Julia, Binette, Francois, Melican, Mora Carolynne, Zimmerman, Mark
• Primary Examiner(s): Weber; Jon P
• Assistant Examiner(s): Singh; Satyendra K
• Application Number:
  US10/374,754
• Publication Number:
  US 20040078077A1
• Time in Patent Office: 2,807 Days
• Field of Search: None
• US Class Current: 424/423
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 2430/10 for reconstruction of tendons or ligaments
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3662 Ligaments, tendons
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment

Abstract

A biocompatible ligament repair implant or scaffold device is provided for use in repairing a variety of ligament tissue injuries. The repair procedures may be conducted with ligament repair implants that contain a biological component that assists in healing or tissue repair. The biocompatible ligament repair implants include a biocompatible scaffold and particles of viable tissue derived from ligament tissue or tendon tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Claims

1. A tendon or ligament repair implant, comprising:

a biocompatible porous scaffold having an aspect ratio in the range of greater than 2 and less than 100; and

at least one minced tissue fragment derived from ligament tissue or tendon tissue, the at least one tissue fragment distributed on at least a portion of the scaffold at a concentration in the range of about 1 to about 100 mg/cm², wherein the at least one tissue fragment has a particle size in the range of about 0.1 mm³ to less than 1 mm³;

wherein the scaffold is made from polymers or copolymers formed from monomers selected from the group consisting of lactide, glycolide, dioxanone, and caprolactone.

2. The implant of claim 1, wherein the scaffold has a cylindrical shape.

3. The implant of claim 1, wherein the scaffold is made from a copolymer of 95:

5 lactide and glycolide.

4. The implant of claim 1, wherein the implant further includes natural polymers selected from the group consisting of collagen, fibrin, and silk.

5. The implant of claim 2, wherein the implant includes strips of collagen or silk present within an inner portion of the scaffold or on a peripheral portion of the scaffold.

6. The implant of claim 1, wherein the scaffold has a diameter in the range of about 3 to 12 mm.

7. The implant of claim 1, wherein the scaffold has a tensile strength and an elastic modulus similar to that of native tendon or ligament tissue.

8. The implant of claim 7, wherein the tensile strength of the scaffold is in the range of about 1000N to 2500N.

9. The implant of claim 7, wherein the elastic modulus of the scaffold is in the range of about 150 N/m to 200 N/m.

10. The implant of claim 1, wherein the scaffold has a slow resorption profile.

11. The implant of claim 10, wherein the resorption profile of the scaffold spans at least three months.

12. The implant of claim 1, wherein the scaffold is formed from a foam component reinforced with a mesh component.

13. The implant of claim 12, wherein the mesh component includes polydioxanone and the foam component is a copolymer of 35:

65 ε

-caprolactone and glycolide.

14. The implant of claim 12, wherein the scaffold has an open pore structure with pores having a size sufficient to allow cell and tissue ingrowth.

15. The implant of claim 14, wherein the pores have an average diameter in the range of about 50 to 1000 microns.

16. The implant of claim 12, wherein the foam component has a thickness in the range of about 300 microns to 2 mm.

17. The implant of claim 12, wherein the mesh component has a mesh density in the range of about 12% to 80%.

18. The implant of claim 1, wherein the scaffold is formed of a plurality of filaments.

19. The implant of claim 18, wherein the majority of fibers that form the filaments are aligned in a longitudinal direction.

20. The implant of claim 1, wherein the scaffold is formed from a material selected from the group consisting of a knit material, a woven material, and a braided material.

21. The implant of claim 12, wherein the mesh is formed on the outer surface of the scaffold.

22. The implant of claim 20, wherein the mesh is a knit or a woven structure.

23. The implant of claim 20, wherein the mesh is biodegradable and biocompatible.

24. The implant of claim 1, further comprising an autograft selected from the group consisting of ligament tissue, bone-patellar tendons, tendon-bone tendons, hamstring tendons, and iliotibial band.

25. The implant of claim 24, wherein the implant and the autograft are configured in an orientation selected from the group consisting of the implant being placed around the autograft, the implant being surrounded by the autograft, and the implant being placed alongside the autograft.

26. The implant of claim 1, wherein the biocompatible scaffold further comprises at least one additional biological component applied thereto.

27. The implant of claim 26, wherein the at least one additional biological component comprises growth factors, matrix proteins, peptides, antibodies, enzymes, cytokines, isolated cells, platelets, and combinations thereof.

28. The implant of claim 1, wherein the biocompatible scaffold further comprises an adhesion agent for anchoring the suspension of tissue fragment to the biocompatible scaffold.

29. The implant of claim 28, wherein the adhesion agent comprises an anchoring agent selected from the group consisting of hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP), Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, and combinations thereof.

30. The implant of claim 28, wherein the adhesion agent comprises a cross-linking agent selected from the group consisting of divinyl sulfone (DVS), polyethylene glycon divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinyl sulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes, isocyanates, alkyl and aryl halides, imidoesters, N-substituted maleimides, acylating compounds, carbodiimide, hydroxychloride, N-hydroxysuccinimide, light, pH, temperature, and combinations thereof.

31. The implant of claim 1, wherein the scaffold has an elliptical shape.

32. The implant of claim 1, wherein the tissue fragments include cells that migrate to the scaffold and proliferate therein.

33. The implant of claim 14, wherein cells migrate from the tissue fragments to the scaffold and proliferate therein.