NONWOVEN TISSUE SCAFFOLD

• US 20070031470A1
• Filed: 06/29/2006
• Published: 02/08/2007
• Est. Priority Date: 04/20/2004
• Status: Active Grant

• Current Assignee: DePuy Synthes Products LLC (Johnson & Johnson)
• Original Assignee: DePuy Mitek Incorporated (Johnson & Johnson)
• Inventors: Dhanaraj, Sridevi, Timmer, Mark, Hammer, Joseph, Kladakis, Stephanie, Dhanuraj, Shetty
• Granted Patent: US 8,221,780 B2
• Time in Patent Office: Days
• US Class Current: 424/424
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/3872 Meniscus for implantation between the natural bone surfaces
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• 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: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A biocompatible meniscal repair device is disclosed. The tissue repair device includes a scaffold adapted to be placed in contact with a defect in a meniscus, the scaffold comprising a high-density, dry laid nonwoven polymeric material and a biocompatible foam. The scaffold provides increased suture pull-out strength.

Claims

1. A biocompatible meniscal repair device, comprising;

a biocompatible tissue repair scaffold adapted to be placed in contact with a defect in a meniscus, wherein the scaffold comprises a nonwoven polymeric material, and wherein the scaffold has a modulus of elasticity greater than about 1.5 MPA and a suture pull-out strength greater than about 6 N.

2. The repair device of claim 1, wherein the tissue repair scaffold has a peak stress greater than about 2 MPa.

3. The repair device of claim 1, wherein the tissue repair scaffold has a suture pull-out strength less than about 45 N.

4. The repair device of claim 1, wherein the tissue repair scaffold has a modulus of elasticity less than about 40 MPa.

5. The repair device of claim 1, wherein the tissue repair scaffold has a thickness in the range of about 0.5 mm to 1.5 mm.

6. The repair device of claim 1, wherein the tissue repair scaffold further comprises a biocompatible foam material joined to the nonwoven polymeric material.

7. The repair device of claim 1, the nonwoven polymeric material comprises a synthetic polymer.

8. The repair device of claim 1, wherein the tissue repair scaffold is bioabsorbable.

9. The repair device of claim 1, wherein the nonwoven polymeric material comprises a material formed by a dry lay process.

10. The repair device of claim 1, wherein the nonwoven polymeric material is formed from at least one polymer derived from monomers selected from the group consisting of glycolide, lactide, caprolactone, trimethylene carbonate, polyvinyl alcohol, and dioxanone.

11. The repair device of claim 10, wherein the nonwoven polymeric material comprises polydioxanone.

12. The repair device of claim 10, wherein the nonwoven polymeric material comprises a copolymer of polyglycolic acid and polylactic acid.

13. The repair device of claim 1, further comprising at least one bioactive substance effective to stimulate cell growth.

14. The repair device of claim 13, wherein the bioactive substance is selected from the group consisting of a platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, and combinations thereof.

15. The repair device of claim 14, wherein the bioactive substance is rhGDF.

16. The repair device of claim 15, wherein the bioactive substance is rhGDF-5.

17. The repair device of claim 1, further comprising a viable tissue sample disposed on the tissue repair scaffold and effective to integrate with native tissue adjacent to the tissue repair scaffold.

18. The repair device of claim 1, wherein the nonwoven polymeric material comprises crimped, synthetic polymer fibers.

19. The repair device of claim 1, wherein the nonwoven polymeric material is heat-set.

20. The repair device of claim 1, wherein the fiber orientation of the nonwoven polymeric material is isotropic.

21. A biocompatible meniscal repair device, comprising;

a biocompatible tissue repair scaffold adapted to be placed in contact with a defect in a meniscus, the scaffold including,

(a) a high-density, dry laid nonwoven polymeric material; and

(b) a biocompatible foam,

wherein, the scaffold provides increased suture pull-out strength.

22. The repair device of claim 21, wherein the tissue repair scaffold has a peak stress in the range of about 2 MPa to 14 MPa.

23. The repair device of claim 21, wherein the tissue repair scaffold has a suture pull-out strength in the range of about 6 N to 45 N.

24. The repair device of claim 21, wherein the tissue repair scaffold has a modulus of elasticity in the range of about 1.5 MPa to 40 MPa.

25. The repair device of claim 21, wherein the tissue repair scaffold has a thickness in the range of about 0.5 mm to 1.5 mm.

26. The repair device of claim 21, the nonwoven polymeric material comprises a synthetic polymer.

27. The repair device of claim 21, wherein the tissue repair scaffold is bioabsorbable.

28. The repair device of claim 21, further comprising at least one bioactive substance effective to stimulate cell growth.

29. The repair device of claim 28, wherein the bioactive substance is selected from the group consisting of a platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, and combinations thereof.

30. The repair device of claim 29, wherein the bioactive substance is rhGDF.

31. The repair device of claim 30, wherein the bioactive substance is rhGDF-5.

32. The repair device of claim 21, further comprising a viable tissue sample disposed on the tissue repair scaffold and effective to integrate with native tissue adjacent to the tissue repair scaffold.

33. A method of surgically repairing meniscal defects, comprising:

providing a biocompatible tissue repair scaffold having a modulus of elasticity greater than about 1.5 MPA and a suture pull-out strength greater than about 6 N;

positioning the tissue repair scaffold in contact with a tissue defect in a meniscus; and

fixing tissue repair scaffold in position with sutures,

wherein the repair scaffold provides increased suture pull-out strength and thereby promotes healing of the meniscus.

34. The method of claim 33, wherein at least one bioactive substance effective to stimulate cell growth is implanted with the tissue repair scaffold.

35. The method of claim 34, wherein the bioactive substance is selected from the group consisting of a platelet rich plasma, cartilage-derived morphogenic proteins, recombinant human growth factors, and combinations thereof.

36. The repair device of claim 35, wherein the bioactive substance is rhGDF.

37. The repair device of claim 36, wherein the bioactive substance is rhGDF-5.