Claims for Patent: 7,488,348

Summary for Patent: 7,488,348

Title:	Cartilage allograft plug
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.
Inventor(s):	Truncale; Katherine G. (Hillsborough, NJ), Sunwoo; Moon Hae (Old Tappan, NJ), Gertzman; Arthur A. (Stony Point, NY), Tomford; William W. (Belmont, MA), Yannariello-Brown; Judith I. (Somerset, NJ)
Assignee:	Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:	11/151,270
Patent Claims:	1. In combination, minced cartilage putty comprising milled cartilage pieces mixed in a biocompatible carrier and a sterile, cylindrically-shaped allograft bone plug, said plug including a subchondral bone portion, which has a diameter selected to form an interference fit against a subchondral bone layer exposed as a result of a bore formed in a defect area in articular cartilage of a host, and an integral overlying cartilage cap which has been treated to remove cellular debris, chondrocytes and proteoglycans, said cap having a first cap portion, which is located proximal to said subchondral bone portion of said plug, said first cap portion having a diameter the same as that of said subchondral bone portion of said plug, and a second cap portion, which is located remote from said subchondral bone portion of said plug and which has a diameter less than that of said subchondral bone portion of said plug, said first and second cap portions being separated by an annular step which forms a ring-shaped gap positionable alongside a cartilage layer exposed as a result of a bore formed in a defect area in articular cartilage of a host, said gap being sized and shaped so as to receive said minced cartilage putty for promoting cartilage cell growth in said gap and for enhancing tissue integration between said plug and host tissue, when said plug is inserted into a bore formed in a defect area in articular cartilage of a host. 2. The combination as claimed in claim 1, wherein said first cap portion has a cylindrical shape, and said second can portion has a cylindrical shape. 3. The combination as claimed in claim 1, wherein said first cap portion has a frustum conical shape and said second cap portion has a cylindrical shape. 4. The combination as claimed in claim 3, wherein said first cap portion includes a small diameter end positioned adjacent said second cap portion, and a large diameter end positioned adjacent said subchondral bone potion. 5. The combination as claimed in claim 1, wherein said milled cartilage pieces are individually sized pieces having a size less than 1 mm. 6. The combination as claimed in claim 5, wherein said milled cartilage pieces are derived from hyaline cartilage. 7. The combination as claimed in claim 1, further comprising a chondrogenic stimulating factor mixed with said milled cartilage pieces and said biocompatible carrier. 8. The combination as claimed in claim 7, 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-.beta., BMP-2, BMP-7, PDGF, PRP, VEGF), recombinant, native growth factors, human allogenic or autologous chondrocytes, human allogenic or autologous bane 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. 9. The combination as claimed in claim 1, 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. 10. The combination as claimed in claim 1, wherein said allograft bone plug has been lyophilized so that its water content ranges from about 0.1% to about 8.0%. 11. The combination as claimed in claim 1, wherein said allograft bone plug is coated with a solution containing an adeno-associated virus segment carrying a cartilage growth gene. 12. The combination as claimed in claim 1, wherein said allograft 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, naked DNA, RNAi, biological and other types of nanoparticles that can code for DNA or cytokines. 13. The combination as claimed in claim 1, wherein said allograft bone plug is coated with a solution containing a recombinant adeno-associated virus segment carrying a cartilage growth gene. 14. The combination as claimed in claim 1, wherein when said ring-shaped gap has a width in a range from 50 microns to 1000 microns. 15. The combination as claimed in claim 1, wherein when said ring-shaped gap has a width in a range from 100 microns to 500 microns. 16. The combination as claimed in claim 1, wherein said allograft bone plug has been sterilized in an antibiotic soak. 17. The combination as claimed in claim 1, wherein the diameter of said second cap portion is in a range from about 200 microns to about 1000 microns less than the diameter of said subchondral bone portion. 18. A method of repairing an articular cartilage defect of a patient, said method comprising the steps of: (a) providing a sterile, cylindrically-shaped allograft bone plug, the plug including a subchondral bone portion and an integral overlying cartilage cap which has been treated to remove cellular debris, chondrocytes and proteoglycans, the cap having a first cap portion, which is located proximal to the subchondral bone portion of the plug, the first cap portion having a diameter the same as that of the subchondral bone portion of the plug, and a second cap portion, which is located remote from the subchondral bone portion of the plug, the second cap portion having a diameter less than that of the subchondral bone portion of the plug, the first end second cap portions being separated by an annular step formed in the cartilage cap; (b) forming a bore in an articular cartilage defect area of the patient, the bore exposing a subchondral bone layer and a cartilage layer in the defect area; (c) inserting the plug into the bore so that (i) the subchondral bone portion of the plug forms an interference fit against the exposed subchondral bone layer and (ii) the second cap portion of the plug is spaced from the exposed cartilage layer to thereby cooperate with the annular step in the formation of a ring-shaped gap positioned alongside the exposed cartilage layer; and (d) providing the ring-shaped gap with minced cartilage putty to promote cartilage cell growth in the gap and to enhance tissue integration between the plug and the patient's tissue, the cartilage putty comprising milled cartilage pieces mixed in a biocompatible carrier. 19. The method as claimed in claim 18, wherein the milled cartilage pieces have a size less than 1 mm. 20. The method as claimed in claim 19, wherein the milled cartilage pieces are derived from hyaline cartilage. 21. The method as claimed in claim 19, wherein the minced cartilage putty includes a chondrogenic stimulating factor mixed with the milled cartilage pieces and the biocompatible carrier. 22. The method as claimed in claim 18, wherein the diameter of the second cap portion is in a range from about 200 microns to about 1000 microns less than the diameter of said subchondral bone portion. 23. The method as claimed in claim 18, wherein the 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. 24. The method as claimed in claim 18, further comprising a step of lyophilizing the plug so that its water content is in a range from about 0.1% to about 8.0%. said lyophilizing step being performed before said bore-forming step (b). 25. The method as claimed in claim 18, wherein the ring-shaped gap has a width in a range from 50 microns to 1000 microns. 26. The method as claimed in claim 18, wherein the ring-shaped gap has a width in a range from 100 microns to 500 microns.

Details for Patent 7,488,348

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-05-16