Particulate cadaveric allogenic cartilage system

• US 8,784,863 B2
• Filed: 12/22/2010
• Issued: 07/22/2014
• 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:
  US12/976,704
• Publication Number:
  US 20120087948A1
• Time in Patent Office: 1,308 Days
• Field of Search: None
• US Class Current: 424/423
• 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 cartilage treatment kit comprising:

cadaveric, allogenic human juvenile cartilage particles including viable chondrocytes;

biocompatible chondro-conductive/inductive matrix;

a biocompatible storage solution; and

a sealed, sterile container in which the cartilage particles and storage solution are disposed;

wherein the container is positioned within a sealed, sterile pouch having a hollow interior.

2. The kit of claim 1, wherein the container comprises:

a tray having a lip surrounding a receptacle; and

a removable cover attached to the lip of the tray for sealing the receptacle.

3. The kit of claim 1, wherein the storage solution comprises at least one preservative.

4. The kit of claim 3, wherein the preservative comprises a buffer, an amino acid, a sugar, a salt, a mineral or combinations thereof.

5. The kit of claim 1, wherein the juvenile cartilage particles are from cadaveric juvenile donors less than fifteen years of age.

6. The kit of claim 5, wherein the juvenile cartilage particles are from cadaveric juvenile donors less than two years of age.

7. The kit of claim 5, wherein the juvenile cartilage particles are from cadaveric juvenile donors from about 20 weeks to about 13 years of age.

8. The kit of any one of claim 1, 3 or 5, wherein the kit comprises juvenile cartilage particles having a dimension from about one to about three millimeters.

9. The kit of claim 5, wherein the juvenile cartilage particles are from a cartilage site scored in a grid pattern.

10. The kit of claim 9, wherein the grid pattern is a square grid pattern.

11. The kit of any one of claim 1, 3 or 5, wherein the kit comprises juvenile cartilage particles range in size from about 1 to about 27 mm³.

12. The kit of any one of claim 1, 3 or 5, wherein the juvenile cartilage particles comprise at least 1×

10⁶ chondrocytes.

13. The kit of any one of claim 1, 3 or 5, comprising at least 60 mg of juvenile cartilage particles.

14. The kit of any one of claim 1, 3 or 5, wherein the cartilage particles comprise articular cartilage.

15. The kit of claim 14, wherein the articular cartilage is harvested from a femoral condyle a tibial plateau or an interior surface of a patella.

16. The kit of claim 1, wherein the cartilage is distributed throughout substantially all of the matrix or just a portion of the matrix.

17. The kit of claim 1, wherein the chondro-conductive/inductive matrix comprises fibrinogen, fibrinogen/thrombin, albumin, in-situ forming poly(ethylene glycol) (PEG) hydrogel, fibrin/hyaluronate, fibrin/collagen/hyaluronate, PEG/hyaluronate, PEG/collagen, plasma and protein-based adhesives and sealants, natural adhesives and sealants and any combination thereof.

18. The kit of claim 1 further comprising an osteo-conductive matrix.

19. The kit of claim 18, wherein the osteo-conductive matrix comprises fibrinogen, fibrinogen/thrombin, fibrin/tri-calcium phosphate, fibrin/collagen/tri-calcium phosphate, fibrin/hyaluronate/tri-calcium phosphate, in-situ forming PEG hydrogel sealants, PEG/tri-calcium phosphate, PEG/collagen, demineralized bone matrix, and any combination thereof.

20. The kit of claim 18 further comprising an associated matrix comprising collagen, polylactic acid (PLA), polyglycolic acid (PGA), and combinations thereof.