Treatment methods using a particulate cadaveric allogenic juvenile cartilage particles

• US 8,834,914 B2
• Filed: 12/22/2010
• Issued: 09/16/2014
• Est. Priority Date: 12/11/2003
• Status: Active Grant

• Current Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Zimmer Incorporated (Zimmer Biomet Holdings, Inc.)
• Inventors: Kizer, Neil, Spiro, Robert, Yao, Jian, Blanchard, Cheryl Renee
• Primary Examiner(s): AZPURU, CARLOS A
• Application Number:
  US12/976,689
• Publication Number:
  US 20120009270A1
• Time in Patent Office: 1,364 Days
• US Class Current: 424/426
• CPC Class Codes: A61F 2/28 Bones joints A61F2/30
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2002/30766 Scaffolds for cartilage ingrowth and regeneration
• CPC Class Codes: A61F 2310/00293 containing a phosphorus-containing compound, e.g. apatite
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00377 Fibrin
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• CPC Class Codes: A61L 2430/06 for cartilage reconstruction, e.g. meniscus
• CPC Class Codes: A61L 27/3612 Cartilage, synovial fluid
• CPC Class Codes: A61L 27/3654 Cartilage, e.g. meniscus
• 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
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/3852 Cartilage, e.g. meniscus
• CPC Class Codes: A61P 19/00 Drugs for skeletal disorders
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 19/08 for bone diseases, e.g. rachitism, Paget's disease
• CPC Class Codes: C12N 2533/56 Fibrin; Thrombin
• CPC Class Codes: C12N 2533/80 Hyaluronan
• CPC Class Codes: C12N 5/0655 : Chondrocytes; Cartilage

Abstract

The present invention is directed to compositions having at least one neocartilage particle, juvenile cartilage particle or a combination thereof and a matrix, and methods and devices that include the compositions.

Claims

1. A method of treating a cartilage defect, comprising:

implanting cadaveric, allogenic human juvenile cartilage tissue particles including viable chondrocytes into the defect; and

depositing a chondro-conductive matrix into the defect.

2. The method of claim 1, wherein the cartilage particles are implanted and the chondro-conductive matrix is deposited simultaneously.

3. The method of claim 1, wherein the cartilage particles are implanted and the chondro-conductive matrix is deposited sequentially.

4. The method of claim 2 or 3, wherein the cartilage particles are implanted and the chondro-conductive matrix is deposited through a cannulated device.

5. The method of claim 2 or 3, wherein the cartilage particles are implanted and the chondro-conductive matrix is molded to the defect during a period of plasticity of the chondro-conductive matrix.

6. The method of claim 2, wherein the cartilage particles and the chondro-conductive matrix comprise a single construct.

7. The method of claim 6, wherein a preformed single construct is produced by delivering the cartilage particles and the chondro-conductive matrix to a mold.

8. The method of claim 7, wherein the preformed single construct is attached to cartilage or bone adjacent the defect by gluing.

9. The method of claim 4, wherein the cartilage particles and the chondro-conductive matrix are mixed during deposition.

10. The method of claim 3, wherein chondro-conductive matrix is deposited after cartilage particles are implanted into the defect.

11. The method of claim 1, further comprising applying a retainer to the defect.

12. The method of claim 11, wherein the retainer is selected from the group consisting of a flap, plug, disc, sheet or patch overlaying the cartilage particles and the chondro-conductive matrix.

13. The method of claim 11, wherein the retainer comprises a glue.

14. The method of claim 11, wherein the retainer is selected from the group consisting of a suture, tack or staple.

15. The method of claim 1, further comprising treating a bone defect adjacent the cartilage defect with an osteo-conductive matrix.

16. The method of claim 15, wherein the osteo-conductive matrix is deposited up to the tide mark adjacent the cartilage defect.

17. The method of claim 15, wherein the osteo-conductive matrix is selected from the group consisting of a porous solid, semisolid, paste or gel.

18. The method of claim 15, wherein the osteo-conductive matrix is selected from the group consisting of bone or a calcium phosphate containing composition.

19. The method of claim 18, wherein the bone is demineralized.

20. The method of claim 1, further comprising removing the cartilage particles from a container including a biocompatible storage solution.

21. The method of claims 20, wherein the storage solution comprises at least one preservative.

22. The method of claim 1, wherein the cartilage particles have a dimension from about one to about three millimeters.

23. The method of any one of claim 1, 2, 3, 11, 15 or 20, wherein the cartilage particles range in size from about 1 to about 27 mm³.

24. The method of claim 1, wherein the cartilage particles comprise at least 1×

10⁶ chondrocytes.

25. The method of claim 1, 2, 3, 11, 15 or 20, wherein the cartilage particles are distributed throughout 90% or less of the chondro-conductive matrix.

26. The method of claim 25, wherein the cartilage particles are distributed throughout 60% or less of the chondro-conductive matrix.

27. The method of claim 26, wherein the cartilage particles are distributed throughout 30% or less of the chondro-conductive matrix.

28. The method of claim 1, wherein the cartilage particles are homogeneously distributed within the chondro-conductive matrix.

29. The method of claim 1, wherein the cartilage particles are heterogeneously distributed within the chondro-conductive matrix.

30. The method of claim 29, wherein the cartilage particles are at a higher concentration in the chondro-conductive matrix near the bottom of the defect.

31. The method of claim 1, 2, 3, 11, 15 or 20, wherein the defect is an articular cartilage defect.

32. The method of claim 1, wherein the cartilage particles comprise articular cartilage.

33. The method of claim 32, wherein the cartilage particles comprise cartilage from a femoral condyle, a tibial plateau or an interior surface of a patella.

34. The method of claim 1, wherein the chondro-conductive matrix is selected from the group consisting of plasma-based adhesives or sealants, and protein-based adhesives or sealants, natural adhesives or sealants and any combination thereof.

35. The method of claim 34, wherein the chondro-conductive matrix is fibrin.

36. The method of claim 1, 2, 3, 11, 15 or 20, wherein the cartilage particles are from cadaveric juvenile donors less than fifteen years of age.

37. The method of claim 36, wherein the cartilage particles are from cadaveric juvenile donors less than two years of age.

38. The method of claim 36, wherein the cartilage particles are from cadaveric juvenile donors from about 20 weeks to about 13 years of age.