Synovial fluid barrier

• US 20060178743A1
• Filed: 02/10/2005
• Published: 08/10/2006
• Est. Priority Date: 02/10/2005
• Status: Active Grant

• Current Assignee: Spine Wave Incorporated
• Original Assignee: Spine Wave Incorporated
• Inventors: Carter, Andrew
• Granted Patent: US 7,825,083 B2
• Time in Patent Office: Days
• US Class Current: 623/13.170
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61F 2/30742 Bellows or hose-like seals; Sealing membranes A61B17/8808 takes precedence; sealing membranes for retaining bone substitute A61F2/2846
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4618 of cartilage
• CPC Class Codes: A61F 2002/30673 Lubricating means, e.g. synovial pocket
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30736 Augments or augmentation pieces, e.g. wedges or blocks for bridging a bone defect
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61L 27/227 Other specific proteins or polypeptides not covered by A61L27/222, A61L27/225 or A61L27/24

Abstract

A composite tissue formed in situ is provided. The composite tissue includes a synovial joint tissue; and a barrier material adhered thereto for sealing the synovial joint tissue against synovial fluid. Also provided is a method for regenerating synovial joint tissue in situ by excluding synovial fluid therefrom. The method includes providing a synovial joint tissue having a defect; and placing a barrier material in intimate contact with the defect for sealing the defect against synovial fluid. The barrier material includes a curable protein copolymer. The method further includes curing the protein copolymer in situ. The barrier material can include a crosslinked network, or a self gelled network of repeating elastin-like and fibroin-like polymer chains.

Claims

1. A composite tissue formed in situ comprising:

a synovial joint tissue; and

a barrier material adhered thereto for sealing the synovial joint tissue against synovial fluid.

2. The composite tissue of claim 1, wherein the synovial joint tissue has a defect sealable by the barrier material.

3. The composite tissue of claim 1, wherein the barrier material comprises a crosslinked network, or a self gelled network of repeating elastin-like and fibroin-like polymer chains.

4. The composite tissue of claim 1, wherein the elastin-like and fibroin-like polymer chains are chemically crosslinked.

5. The composite tissue of claim 1, wherein the elastin-like and fibroin-like polymer chains self associate to form a gel.

6. The composite tissue of claim 3, wherein the repeating fibroin-like polymer chains of the barrier material comprise the sequence:

GAGAGS (SEQ ID NO;

1).

7. The composite tissue of claim 3, wherein the repeating elastin-like polymer chains of the barrier material comprise the sequence:

GVGVP (SEQ ID NO;

2).

8. The composite tissue of claim 3, wherein the repeating elastin-like polymer chains comprise the sequence:

GKGVP (SEQ ID NO;

3), wherein the K serves as a cross-linking site.

9. The composite tissue of claim 1, wherein the barrier material comprises an in situ curable acrylate polymer, including cyanoacrylate.

10. The composite tissue of claim 1, wherein the barrier material comprises an in situ curable polyurethane.

11. The composite tissue of claim 1, wherein the synovial joint tissue is cartilage.

12. The composite tissue of claim 1, wherein the synovial joint tissue is a ligament.

13. The composite tissue of claim 12, wherein the ligament is selected from posterior cruciate ligament and anterior cruciate ligament.

14. The composite tissue of claim 13, wherein the ligament is a lacerated or severed ligament.

15. The composite tissue of claim 14, further comprising sutures and/or an augmentation device to provide mechanical stability to the lacerated or severed ligament during healing.

16. The composite tissue of claim 15, wherein the augmentation device is an artificial augmenting strip or sleeve.

17. The composite tissue of claim 1, wherein the synovial joint is the facet joint of the spine.

18. The composite tissue of claim 1, wherein the synovial joint is the knee.

19. The composite tissue of claim 1, wherein the barrier material provides attachment and growth of autologous chondrocytes.

20. The composite tissue of claim 1, wherein the barrier material provides attachment and growth of autologous mesenchymal stem cells.

21. The composite tissue of claim 1, wherein the barrier material further includes seed cells.

22. The composite tissue of claim 21, wherein the seed cells are selected from the group consisting of chondrocytes and mesenchymal stem cells.

23. The composite tissue of claim 1, wherein the barrier material further includes a biologically active agent.

24. The composite tissue of claim 23, wherein the biologically active agent is selected from the group consisting of growth factors and cytokines.

25. A barrier system formed as a polymeric coating on a synovial joint tissue surface by:

(a) applying a curable protein copolymer solution to the synovial joint tissue surface; and

(b) curing the protein copolymer in situ, thereby forming an effective barrier on the synovial joint tissue surface against synovial fluid.

26. The barrier system of claim 25, wherein the copolymer solution comprises repeating elastin-like and fibroin-like polymer chains.

27. The barrier system of claim 25, wherein the protein copolymer is cured by chemically crosslinking the fibroin-like and elastin-like polymer chains.

28. The barrier system of claim 27, which is formed by further applying a chemical crosslinker to the synovial joint tissue surface.

29. The barrier system of claim 28, wherein the chemical crosslinker is an isocyanate.

30. A method for regenerating synovial joint tissue in situ by excluding synovial fluid therefrom, the method comprising:

providing a synovial joint tissue having a defect; and

placing a barrier material in intimate contact with the defect for sealing the defect against synovial fluid, the barrier material comprising a curable protein copolymer; and

curing the protein copolymer in situ.

31. The method of claim 30, wherein the barrier material comprises repeating elastin-like and fibroin-like polymer chains that are capable of being crosslinked

32. The method of claim 31, further comprising crosslinking the elastin-like and fibroin-like polymer chains with a chemical crosslinker.

33. The method of claim 32, wherein at least some of the elastin-like polymer chains are modified by replacement of an amino acid with a substitute amino acid that serves as a site of the crosslinking.

34. The method of claim 32, wherein the chemical crosslinker is an isocyanate.

35. The method of claim 34, wherein the isocyanate is hexamethylene diisocyanate (HMDI).

36. The method of claim 30, wherein the placing includes injecting the barrier material into a site of the defect.

37. The method of claim 30, further including seeding the barrier material with seed cells.

38. The method of claim 30, further including accessing pluripotential mesenchymal stem cells in bone proximal to the defective tissue surface for enhanced regeneration thereof.

39. The method of claim 30, wherein the synovial joint tissue is cartilage.

40. The method of claim 30, wherein the synovial joint tissue is a ligament.

41. The method of claim 30, wherein the synovial joint tissue is the facet joint of the spine.

42. A method of treating a wound in synovial joint tissue comprising the steps of:

applying (i) a crosslinkable protein copolymer comprising recombinant elastin and fibroin polymer chains; and

(ii) a crosslinker to the tissue in the presence of synovial fluid;

allowing the recombinant elastin and fibroin polymer chains to crosslink, thereby forming an adherent barrier coating on the tissue, which coating excludes at least a portion of the synovial fluid from the tissue; and

permitting autologous cells to infiltrate the wound beneath the barrier coating to improve regenerative healing.

43. A method of repairing a cartilage defect comprising:

applying a curable protein copolymer solution to a cartilage defect treatment site; and

curing the protein copolymer in situ, thereby forming an effective barrier at the treatment site, which barrier temporarily excludes synovial fluid from the cartilage defect to promote repair thereof.

44. The method of claim 43, wherein the curable copolymer solution comprises repeating elastin-like and fibroin-like polymer chains.

45. The method of claim 43, further comprising applying a chemical crosslinker to the treatment site to effect the curing.

46. The method of claim 43, wherein the cartilage defect is in a knee joint.

47. A method of repairing a torn cruciate ligament comprising:

encapsulating the torn cruciate ligament in a barrier material, which barrier material temporarily seals the torn ligament against synovial fluid to promote repair thereof.

48. The method of claim 47, wherein the barrier material comprises a crosslinked network, or a self gelled network of repeating elastin-like and fibroin-like polymer chains.

49. The method of claim 47, further comprising mechanically supporting the torn ligament to promote repair thereof.

50. The method of claim 49, wherein the mechanical support comprises sutures and/or an augmentation device.

51. The method of claim 50, wherein the augmentation device is an artificial augmenting strip or sleeve.