Cartilage allograft plug

• US 20050251268A1
• Filed: 06/14/2005
• Published: 11/10/2005
• Est. Priority Date: 05/16/2003
• Status: Active Grant

• Current Assignee: Musculoskeletal Transplant Foundation
• Original Assignee: Musculoskeletal Transplant Foundation
• Inventors: Truncale, Katherine Gomes
• Granted Patent: US 7,488,348 B2
• Time in Patent Office: Days
• US Class Current: 623/23.630
• 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 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/3859 Femoral components
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2839 Bone plugs or bone graft dowels
• CPC Class Codes: A61F 2002/30004 the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3021 frustoconical
• CPC Class Codes: A61F 2002/30224 cylindrical
• CPC Class Codes: A61F 2002/30233 Stepped cylinders, i.e. having discrete diameter changes
• CPC Class Codes: A61F 2002/30235 tubular, e.g. sleeves
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30764 Cartilage harvest sites
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0014 having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
• CPC Class Codes: A61F 2310/00365 Proteins; Polypeptides; Degradation products thereof
• CPC Class Codes: A61F 2310/00383 Gelatin
• CPC Class Codes: A61L 27/3608 : Bone, e.g. demineralised bone matrix [DBM], bone powder
• 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

Abstract

The invention is directed toward a cartilage repair assembly comprising a cylindrically shaped allograft structure of subchondral bone with an integral overlying smaller diameter cartilage cap which is treated to remove cellular debris and proteoglycans. The shaped structure is dimensioned to fit in a drilled bore in a cartilage defect area so that the subchondral bone of the structure engages the side wall of the bone portion of the drilled bore in an interference fit while the cartilage cap is spaced from cartilage portion of the side wall of the drilled bore forming a gap in which a milled cartilage and biocompatible carrier mixture is placed allowing cell transfer throughout the defect area. A method for inserting the shaped allograft structure into a cartilage defect area is also disclosed.

Claims

1. A cartilage repair assembly for repair of a defect in articular cartilage of a mammal comprising a sterile allograft bone plug having a subchondral bone portion sized so that said bone portion has an interference fit against a bone layer of a drilled bore in a cartilage defect area, said drilled hole being defined by a cartilage layer and a subchondral bone layer, and an integral overlying smaller surfaced cartilage cap which is spaced from the cartilage layer of said drilled bore, said allograft bone plug having been treated to remove cellular debris and proteoglycans

2. A cartilage repair assembly as claimed in claim 1 wherein said allograft bone plug is cylindrically shaped with a cylindrical bone portion of a first diameter size and a smaller sized diameter cylindrical cartilage cap.

3. A cartilage repair assembly as claimed in claim 1 wherein milled cartilage pieces mixed in a biocompatible carrier is placed around said smaller sized cartilage cap.

4. A cartilage repair assembly as claimed in claim 1 wherein said allograft bone plug has a cylindrically shaped bone portion and a cylindrically step cut overlying cartilage cap.

5. A cartilage repair assembly as claimed in claim 1 wherein said allograft bone plug has a cylindrically shaped bone portion and a frustoconical shaped overlying cartilage cap.

6. A cartilage repair assembly as claimed in claim 1 wherein said frustoconical shaped cartilage cap comprises a frustoconical body and a cylindrical top.

7. A cartilage repair assembly as claimed in claim 3 wherein said milled cartilage are individually sized pieces less than 1 mm.

8. A cartilage repair assembly as claimed in claim 7 wherein said milled cartilage is hyaline cartilage.

9. A cartilage repair assembly as claimed in claim 3 wherein said milled cartilage pieces and carrier includes a chondrogenic stimulating factor.

10. A cartilage repair assembly as claimed in claim 9 wherein said chondrogenic stimulating factor is one or more of a group consisting of growth factors (FGF-2, FGF-5, FGF-7, FGF-9, IGF-1, TGF-β

, BMP-2, BMP-7, PDGF, PRP, VEGF), recombinant, native growth factors, human allogenic or autologous chondrocytes, human allogenic or autologous bone marrow cells, stem cells, demineralized bone matrix, insulin, insulin-like growth factor-1, transforming growth factor-B, interleukin-1 receptor antagonist, hepatocyte growth factor, platelet-derived growth factor, Indian hedgehog and parathyroid hormone-related peptide or bioactive glue.

11. A cartilage repair assembly as claimed in claim 3 wherein said biocompatible carrier comprises one or more of a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran, polymers, and synthetic and peptide based hydrogels.

12. A cartilage repair assembly as claimed in claim 1 wherein said bone plug has been lyophilized so it'"'"'s water content ranges from about 0.1% to about 8.0%.

13. A cartilage repair assembly as claimed in claim 1 wherein said bone plug is coated with a solution containing an adeno-associated virus segment carrying a cartilage growth gene.

14. A cartilage repair assembly as claimed in claim 1 wherein said bone plug is coated with a solution containing an adeno-associated virus segment carrying at least one gene from a group consisting of growth factor, DNA, marked DNA, RNAi, biological and other types of nanoparticles that can code for DNA or cytokines.

15. A cartilage repair assembly as claimed in claim 1 wherein said bone plug is coated with a solution containing an recombinant adeno-associated virus segment carrying a cartilage growth gene.

16. A cartilage repair assembly as claimed in claim 1 wherein when said bone plug is placed in an interference fit said cartilage cap is spaced from a bore wall a distance ranging from 50 microns to 1000 microns.

17. A cartilage repair assembly as claimed in claim 1 wherein when said bone plug is placed in an interference fit said cartilage cap is spaced from a bore wall a distance ranging from 100 microns to 500 microns.

18. A cartilage repair assembly comprising a sterile cylindrical shaped structure of subchondral bone with an integral overlying cartilage cap, said shaped structure being dimensioned to have a cylindrical subchondral bone portion in an interference fit in a cut out area of a cartilage defect so that said cylindrical shaped structure subchondral bone and integral cartilage cap are immobile, said cartilage cap having a smaller diameter ranging from 100 microns to 2000 microns less than the diameter of the cylindrically shaped subchondral bone portion, said shaped structure being pre-treated to remove cellular debris and proteoglycans.

19. A cartilage repair assembly as claimed in claim 18 wherein said bone plug is coated with a solution containing an adeno-associated virus segment carrying a cartilage growth gene.

20. A cartilage repair assembly as claimed in claim 18 wherein said bone plug is coated with a solution containing an recombinant adeno-associated virus segment carrying a cartilage growth gene.

21. A cartilage repair assembly as claimed in claim 18 wherein said bone plug is coated with a solution containing an adeno-associated virus segment carrying at least one gene from a group consisting of growth factor, DNA, marked DNA, RNAi, biological and other types of nanoparticles that can code fro DNA or cytokines.

22. A cartilage repair assembly as claimed in claim 18 wherein said allograft bone plug has a cylindrically shaped bone portion and an overlying cartilage cap with a top portion of being cylindrically shaped and of a smaller diameter than the bone portion, said cartilage cap forming a second session.

23. A cartilage repair assembly as claimed in claim 18 wherein said bone plug has been sterilized in an antibiotic soak.

24. A cartilage repair assembly as claimed in claim 18 wherein said cartilage cap diameter ranges from about 200 microns to about 1000 microns less than the diameter of the shaped structure subchondral bone.

25. A cartilage repair device comprising a sterile allograft shaped substantially cylindrical structure formed of subchondral bone and overlying cylindrical shaped integral cartilage cap, said cartilage cap having a diameter ranging from 100 microns to 1000 microns less than the diameter of said shaped structure subchondral bone, said substantially cylindrical shaped structure being dimensioned to fit in a cut out cut in a cartilage defect area so that the subchondral bone of said shaped structure is in an interference fit against subchondral bone in said cut out with a gap occurring between the cartilage cap and the cartilage surrounding said cut out, said substantially cylindrical shaped structure being treated prior to insertion to remove cellular debris and proteoglycans and increase porosity.

26. A cartilage repair device as claimed in claim 25 wherein said cartilage cap has at least one tapered side wall.

27. A method of placing a preshaped allograft implant assembly in a cartilage defect of a human patient, said assembly comprising a subchondral bone and an overlying cartilage cap plug which has been treated to remove cellular debris and proteoglycans and milled cartilage in a carrier comprising the steps of:

(a) cutting a hole in a patient at a site of a cartilage defect area to remove the cartilage defect;

(b) placing a preshaped allograft osteochondral plug having a subchondral bone section which engages the walls defining said hole allowing the structure to be placed in an interference fit within said hole against the patient'"'"'s subchondral bone and a cartilage cap section, said cartilage cap being smaller than the bone section leaving a gap between it and the patient'"'"'s surrounding cartilage; and

(c) placing a mixture of milled cartilage in a bioabsorbable carrier in the gap between the cartilage cap and the surrounding cartilage.