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Last Updated: November 24, 2020

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Claims for Patent: RE42208

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Summary for Patent: RE42208
Title:Glue for cartilage repair
Abstract: The invention is directed toward a sterile cartilage defect implant material comprising milled lyophilized allograft cartilage pieces ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or polymers with allogenic chondrocytes or bone marrow cells in an amount exceeding the natural occurrence of same in hyaline cartilage and adding a cell growth additive.
Inventor(s): Truncale; Katherine Gomes (Hillsborough, NJ), Gertzman; Arthur A. (Flemington, NJ), Sunwoo; Moon Hae (Old Tappan, NJ), Tomford; William W. (Belmont, MA)
Assignee: Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:12/147,042
Patent Claims:1. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material for use in human beings, comprising .Iadd.a mixture including lyophilized, freeze-.Iaddend.milled allograft cartilage pieces .[.sized less.]. .Iadd.having a size not greater .Iaddend.than 1 mm and .Iadd.a bioabsorbable carrier, said cartilage pieces being formed from allograft cartilage that has been .Iaddend.lyophilized so .[.that their.]. .Iadd.as to reduce its .Iaddend.water content .[.ranges from.]. .Iadd.to an amount within the range of from .Iaddend.about 0.1% to about 8.0% .[.in a bioabsorbable carrier.]. .Iadd.by weight.Iaddend..

.[.2. A sterile allograft cartilage defect implant material as claimed in claim 1 wherein said milled cartilage ranges from about 25% to about 50% by weight and said carrier ranges from about 75% to about 50% by weight..].

.[.3. A sterile allograft cartilage defect implant material as claimed in claim 1 wherein said milled cartilage ranges from about 15% to about 30% by weight with the carrier ranging from about 85% to about 70% by weight..].

4. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .Iadd.bioabsorbable .Iaddend.carrier is .Iadd.selected from the group consisting of .Iaddend.sodium hyaluronate and .[.its derivatives.]. hyaluronic acid.

5. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .[.implant material.]. .Iadd.mixture .Iaddend.includes a protein glue.

6. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .[.implant material.]. .Iadd.mixture .Iaddend.includes .[.the addition of.]. autologous chondrocytes .[.to achieve a concentration exceeding the concentration of chondrocytes naturally occurring in the patient.]. .Iadd.at a concentration greater than the concentration of chondrocytes that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years to 55 years.Iaddend..

7. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .[.milled.]. .Iadd.allograft .Iaddend.cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline cartilage.

8. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .[.milled.]. .Iadd.allograft .Iaddend.cartilage .[.is fibrosus cartilage.]. .Iadd.pieces include fibrocartilage.Iaddend..

9. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .[.milled.]. .Iadd.allograft .Iaddend.cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline and .[.fibrosus cartilage.]. .Iadd.fibrocartilage.Iaddend..

10. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.as .Iaddend.claimed in claim 1, .[.including.]. .Iadd.wherein said mixture includes .Iaddend.an additive .[.to said implant material consisting of one or more of a.]. .Iadd.selected from the .Iaddend.group consisting of .Iadd.a .Iaddend.growth .[.factors.]. .Iadd.factor.Iaddend., human allogenic cells, human allogenic bone marrow cells, human autologous bone marrow cells, human allogenic stem cells, human autologous stem cells, .Iadd.a .Iaddend.human demineralized bone matrix, .[.and.]. insulin.Iadd., insulin-like growth factor-1, an interleukin-1, receptor agonist, a hepatocyte growth factor, a platelet-derived growth factor, Indian hedgehog, and a parathryroid hormone-related peptide.Iaddend..

11. A .[.sterile.]. cartilage .Iadd.defect .Iaddend.repair material as claimed in claim 10, wherein said growth .[.factors are one or more of a.]. .Iadd.factor is selected from the .Iaddend.group consisting of FGF-2, FGF-5, IGF-1, TGF-.beta., BMP-2, BMP-7, PDGF, .Iadd.and .Iaddend.VEGF.

12. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 1, wherein said .Iadd.bioabsorbable .Iaddend.carrier .[.comprises one or more bioabsorbable carriers taken.]. .Iadd.is selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of sodium hyaluronate, hyaluronic acid .[.and its derivatives.]. , gelatin, collagen, chitosan, alginate, buffered PBS, Dextran, .[.or.]. .Iadd.and .Iaddend.polymers.

13. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.for use in human beings, .Iaddend.comprising .Iadd.a mixture including lyophilized, freeze-.Iaddend.milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size .[.in.]. .Iadd., .Iaddend.a bioabsorbable carrier .[.taken.]. .Iadd.selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of sodium hyaluronate, .Iadd.hyaluronic acid, .Iaddend.gelatin, collagen, chitosan, alginate, buffered PBS, Dextran, .[.or.]. .Iadd.and .Iaddend.polymers, and allogenic chondrocytes .[.in an amount exceeding the natural occurrence of same in articular cartilage.]. .Iadd.at a concentration greater than the concentration of chondrocytes that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years and 55 years.Iaddend..

14. A .[.sterile.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 13, wherein said allograft articular cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline cartilage.

15. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 13, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.is fibrous cartilage.]. .Iadd.pieces include fibrocartilage.Iaddend..

16. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 13, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline .Iadd.cartilage .Iaddend.and .[.fibrous cartilage.]. .Iadd.fibrocartilage.Iaddend..

17. A .[.sterile.]. cartilage .Iadd.defect .Iaddend.repair material as claimed in claim 13 .[.wherein said implant material includes.]. .Iadd., further comprising .Iaddend.an additive .[.consisting of one or more of a.]. .Iadd.selected from the .Iaddend.group consisting of .Iadd.a .Iaddend.growth .[.factors.]. .Iadd.factor.Iaddend., human allogenic cells, human allogenic bone marrow cells, human autologous bone marrow cells, human allogenic stem cells, human autologous stem cells, demineralized bone matrix, .[.and.]. insulin.Iadd., insulin-like growth factor-1, interleukin-1 receptor agonist, hepatocyte growth factor, platelet-derived growth factor, Indian hedgehog, and parathyroid hormone-related peptide.Iaddend..

18. A .[.sterile.]. cartilage .Iadd.defect .Iaddend.repair material as claimed in claim 17, wherein said growth .[.factors are one or more of a.]. .Iadd.factor is selected from the .Iaddend.group consisting of FGF-2, FGF-5, IGF-1, TGF-.beta., BMP-2, BMP-7, PDGF, .Iadd.and .Iaddend.VEGF.

.[.19. A sterile cartilage defect implant material as claimed in claim 13 wherein said milled cartilage ranges from about 25% to about 50% by weight and said carrier ranges from about 75% to about 50% by weight..].

.[.20. A sterile cartilage defect implant material as claimed in claim 13 wherein said milled cartilage ranges from about 15% to about 30% by weight with the carrier ranging from about 85% to about 70% by weight..].

21. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.for use in human beings, .Iaddend.comprising lyophilized.Iadd., freeze-.Iaddend.milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size .[.in.]. , a bioabsorbable carrier .[.taken.]. .Iadd.selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of sodium hyaluronate, hyaluronic acid .[.and its derivatives.]. , gelatin, collagen, chitosan, alginate, buffered PBS, Dextran .[.or.]. .Iadd., and .Iaddend.polymers.Iadd., .Iaddend.and autologous bone marrow cells .[.in an amount exceeding the natural occurrence of same in a patient being treated.]. .Iadd.at a concentration greater than the concentration of bone marrow cells that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years to 55 years.Iaddend..

22. A .[.sterile.]. cartilage defect repair material as claimed in claim 21 .[.including.]. .Iadd., further comprising .Iaddend.an additive .[.in said implant material which consists of one or more of a.]. .Iadd.selected from the .Iaddend.group consisting of .Iadd.a .Iaddend.growth .[.factors.]. .Iadd.factor.Iaddend., human allogenic cells, autologous chondrocytes, demineralized bone matrix, .[.and.]. insulin.Iadd., insulin-like growth factor-1, an interleukin-1 receptor agonist, a hepatocyte growth factor, a platelet-derived growth factor, Indian hedgehog, and a parathyroid hormone-related peptide.Iaddend..

23. A .[.sterile.]. cartilage .Iadd.defect .Iaddend.repair material as claimed in claim 22, wherein said growth .[.factors are one or more of a.]. .Iadd.factor is selected from the .Iaddend.group consisting of FGF-2, FGF-5, IGF-1, TGF-.beta., BMP-2, BMP-7, PDGF, .Iadd.and .Iaddend.VEGF.

24. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said bioabsorbable carrier .[.consists.]. .Iadd.is selected from the group consisting .Iaddend.of sodium hyaluronate.[.,.]. .Iadd.and .Iaddend.hyaluronic acid .[.and its derivatives.]. .

25. A .[.sterile.]. cartilage defect .Iadd.repair .Iaddend.material as claimed in claim 21; wherein said .[.lyophilized.]. .Iadd.allograft articular .Iaddend.cartilage pieces .[.have ranging from.]. .Iadd.are formed from allograft articular cartilage that has been lyophilized so as to reduce its water content to the range of .Iaddend.about 0.1% to .Iadd.about.Iaddend. 8.0%.

26. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said allograft articular cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline cartilage.

27. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.is fibrous cartilage.]. .Iadd.pieces include fibrocartilage.Iaddend..

28. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.is.]. .Iadd.pieces include .Iaddend.hyaline cartilage and .[.fibrous cartilage.]. .Iadd.fibrocartilage.Iaddend..

29. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.ranges.]. .Iadd.pieces are present in said material at an amount in the range of .Iaddend.from about 25% to about 50% by weight and said .Iadd.bioabsorbable .Iaddend.carrier .[.ranges.]. .Iadd.is present in said material at an amount in the range of .Iaddend.from about .[.75%.]. .Iadd.50% .Iaddend.to about .[.50%.]. .Iadd.75% .Iaddend.by weight.

30. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material as claimed in claim 21, wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.ranges.]. .Iadd.pieces are present in said material in an amount in the range of .Iaddend.from about 15% to about 30% by weight .[.with the.]. .Iadd.and said bioabsorbable .Iaddend.carrier .[.ranging.]. .Iadd.is present in said material in an amount in the range of .Iaddend.from about .[.85%.]. .Iadd.70% .Iaddend.to about .[.70%.]. .Iadd.85% .Iaddend.by weight.

.[.31. A sterile cartilage defect implant material comprising lyophilized milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size in a bioabsorbable carrier taken from a group consisting of sodium hyaluronate, hyaluronic acid and its derivatives, gelatin, collagen, chitosan, alginate, buffered PBS, Dextran or polymers and autologous stem cells in an amount exceeding the natural occurrence of same in a patient being treated..].

32. A method of placing a cartilage defect .Iadd.repair .Iaddend.material in a cartilage defect .Iadd.site in a human being.Iaddend., .[.said.]. .Iadd.the .Iaddend.cartilage .[.defect.]. .Iadd.repair .Iaddend.material .[.comprising.]. .Iadd.having a mixture including lyophilized freeze-.Iaddend.milled allograft articular cartilage .[.which has been lyophilized and mixed in.]. .Iadd.pieces and .Iaddend.a bioabsorbable carrier.Iadd., said method .Iaddend.comprising the steps of: (a) cutting a patient's tissue .[.at a site of a cartilage defect.]. to remove .[.a.]. diseased .[.area of.]. cartilage .Iadd.from the cartilage defect site.Iaddend.; (b) adding .[.autologous.]. cells to .[.said.]. .Iadd.the .Iaddend.mixture .[.of milled allograft cartilage in a bioabsorbable carrier.]. ; (c) placing .[.a.]. .Iadd.the .Iaddend.mixture .[.of milled allograft cartilage.]. with .Iadd.the .Iaddend.added .[.autologous.]. cells .[.in a bioabsorbable carrier in.]. .Iadd.into .Iaddend.the cartilage defect .[.area where cartilage has been removed.]. .Iadd.site.Iaddend.; and (d) placing a cover over the mixture .[.of milled allograft cartilage in a bioabsorbable carrier.]. .Iadd.and the added cells so as .Iaddend.to contain the mixture .Iadd.and the added cells .Iaddend.in .Iadd.the .Iaddend.cartilage defect site .[.for a predetermined period of time.]. .

33. The method of claim 32, .[.wherein.]. .Iadd.further comprising the step of adding .Iaddend.growth factors .[.are added.]. to .[.said.]. .Iadd.the .Iaddend.mixture.

34. The method of claim 32, wherein said .[.autologous.]. cells .[.are.]. .Iadd.include .Iaddend.chondrocytes.

35. The method of claim 32, wherein said .[.autologous.]. cells .[.are.]. .Iadd.include .Iaddend.bone marrow cells.

36. The method of claim 32, wherein said .[.autologous.]. cells .[.are.]. .Iadd.include .Iaddend.stem cells.

37. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.for use in a human being, .Iaddend.comprising .Iadd.a mixture including .Iaddend.lyophilized, .Iadd.freeze-.Iaddend.milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size .[.in.]. , a bioabsorbable carrier .[.taken.]. .Iadd.selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of sodium hyaluronate, hyaluronic acid .[.and its derivatives.]. , and chitosan, and autologous chondrocytes .[.in an amount exceeding the natural occurrence of same in articular cartilage.]. .Iadd.at a concentration greater than the concentration of chondrocytes that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years and 55 years, .Iaddend.wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.ranges.]. .Iadd.pieces are present in said mixture at an amount within the range of .Iaddend.from about 25% to about 50% by weight and said bioabsorbable carrier .[.ranges.]. .Iadd.is present in said mixture at an amount within the range of .Iaddend.from about .[.75%.]. .Iadd.50% .Iaddend.to about .[.50%.]. .Iadd.75% .Iaddend.by weight.

38. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.for use in a human being, .Iaddend.comprising .Iadd.a mixture including .Iaddend.lyophilized, .Iadd.freeze-.Iaddend.milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size .[.in.]. , a bioabsorbable carrier .[.taken.]. .Iadd.selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of gelatin, collagen, and alginate, and autologous chondrocytes .[.in an amount exceeding the natural occurrence of same in articular cartilage.]. .Iadd.at a concentration greater than the concentration of chondrocytes that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years and 55 years, .Iaddend.wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.ranges.]. .Iadd.pieces are present in said mixture at an amount within the range of .Iaddend.from about 25% to about 50% by weight and said bioabsorbable carrier .[.ranges.]. .Iadd.is present in said mixture at an amount within the range of .Iaddend.from about .[.75%.]. .Iadd.50% .Iaddend.to about .[.50%.]. .Iadd.75% .Iaddend.by weight.

39. A .[.sterile allograft.]. cartilage defect .[.implant.]. .Iadd.repair .Iaddend.material .Iadd.for use in a human being, .Iaddend.comprising .Iadd.a mixture including .Iaddend.lyophilized.Iadd., freeze-.Iaddend.milled allograft articular cartilage pieces ranging from 0.01 mm to 1.0 mm in size .[.in.]. , a bioabsorbable carrier .[.taken.]. .Iadd.selected .Iaddend.from .[.a.]. .Iadd.the .Iaddend.group consisting of buffered PBS, Dextran .[.or.]. .Iadd., and .Iaddend.polymers, and autologous chondrocytes .[.in an amount exceeding the natural occurrence of same in articular cartilage.]. .Iadd.at a concentration greater than the concentration of chondrocytes that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years and 55 years.Iaddend., wherein said .[.milled.]. .Iadd.allograft articular .Iaddend.cartilage .[.ranges.]. .Iadd.pieces are present in said mixture at an amount within the range of .Iaddend.from about 25% to about 50% by weight and said bioabsorbable carrier .[.ranges.]. .Iadd.is present in said mixture at an amount within the range of .Iaddend.from about .[.75%.]. .Iadd.50% .Iaddend.to about .[.50%.]. .Iadd.75% .Iaddend.by weight.

.Iadd.40. A cartilage defect repair material as claimed in claim 1, wherein said cartilage pieces are present in said mixture at an amount within the range of from about 25% to about 50% by weight, and said bioabsorbable carrier is present in said mixture at an amount within the range of from about 50% to about 75% by weight. .Iaddend.

.Iadd.41. A cartilage defect repair material as claimed in claim 1, wherein said cartilage pieces are present in said mixture at an amount within the range of from about 15% to about 30% by weight, and said bioabsorbable carrier is present in said mixture at an amount within the range of from about 70% to about 85% by weight. .Iaddend.

.Iadd.42. A cartilage defect repair material as claimed in claim 1, wherein said lyophilized. freeze-milled allograft cartilage pieces lack cell viability. .Iaddend.

.Iadd.43. A cartilage defect repair material as claimed in claim 1, wherein said cartilage defect repair material is free of bone pieces. .Iaddend.

.Iadd.44. A cartilage defect repair material as claimed in claim 1, wherein said lyophilized, freeze-milled allograft cartilage pieces are formed by a process including the steps of harvesting a donor tissue consisting essentially of articular cartilage, lyophilizing said donor tissue, and freeze-milling said donor tissue. .Iaddend.

.Iadd.45. A cartilage defect repair material as claimed in claim 1, wherein said lyophilized, freeze-milled allograft cartilage pieces are formed by milling frozen allograft articular cartilage. .Iaddend.

.Iadd.46. A cartilage defect repair material as claimed in claim 1, wherein said lyophilized, freeze-milled cartilage pieces are formed by freezing allograft cartilage with liquid nitrogen and milling the frozen cartilage. .Iaddend.

.Iadd.47. A cartilage defect repair material as claimed in claim 1, wherein said cartilage defect repair material is free of added chondrocytes. .Iaddend.

.Iadd.48. A cartilage defect repair material as claimed in claim 1, wherein said lyophilized, freeze-milled allograft cartilage pieces have an ability to promote the growth of new articular cartilage in the cartilage defect. .Iaddend.

.Iadd.49. A cartilage defect repair material as claimed in claim 13, wherein said mixture includes a protein glue. .Iaddend.

.Iadd.50. A cartilage defect repair material as claimed in claim 13, wherein said allograft articular cartilage pieces are formed from allograft articular cartilage that has been lyophilized so as to reduce its water content to the range of from about 0.1% to about 8.0% by weight. .Iaddend.

.Iadd.51. A cartilage defect repair material as claimed in claim 13, wherein said cartilage pieces are present in said mixture at an amount within the range of from about 25% to about 50% by weight, and said bioabsorbable carrier is present in said mixture at an amount within the range of from about 50% to about 75% by weight. .Iaddend.

.Iadd.52. A cartilage defect repair material as claimed in claim 13, wherein said cartilage pieces are present in said mixture at an amount within the range of from about 15% to about 30% by weight, and said bioabsorbable carrier is present in said mixture at an amount within the range of from about 70% to about 85% by weight. .Iaddend.

.Iadd.53. A cartilage defect repair material as claimed in claim 21, further comprising a protein glue. .Iaddend.

.Iadd.54. The method of claim 32, further comprising the step of fixing the mixture in the cartilage defect site with an organic glue. .Iaddend.

.Iadd.55. The method of claim 32, further comprising the step of keeping the cover over the mixture for a predetermined period of time that is sufficient to promote cartilage growth at the cartilage defect site. .Iaddend.

.Iadd.56. The method of claim 32, wherein said cover is a periosteal flap. .Iaddend.

.Iadd.57. The method of claim 32, wherein said cover is a perichondrial flap. .Iaddend.

.Iadd.58. The method of claim 32, wherein, in said step (b), the cells are selected from the group consisting of chondrocytes, bone marrow cells and stem cells, and the cells are added so as to achieve a concentration greater than the concentration of corresponding cells that are naturally present in hyaline cartilage of a human being having an age in the range of from 20 years and 55 years. .Iaddend.

.Iadd.59. A cartilage defect repair material for use in human beings, comprising lyophilized, freeze-milled allograft cartilage pieces having a size not greater than 1 mm, wherein said cartilage pieces are included in a mixture that also includes a bioabsorbable carrier, said cartilage pieces being present in said mixture at an amount within the range of from about 25% to about 50% by weight, and said bioabsorbable carrier being present in said mixture at an amount within the range of from about 50% to about 75% by weight. .Iaddend.

.Iadd.60. A cartilage defect repair material as claimed in claim 59, wherein said cartilage pieces are formed from allograft cartilage that has been lyophilized so as to reduce its water content to an amount within the range of from about 0.1% to about 8.0% by weight. .Iaddend.

.Iadd.61. A cartilage defect repair material as claimed in claim 59, wherein said size ranges from 0.01 mm to 1.0 mm. .Iaddend.

.Iadd.62. A cartilage defect repair material as claimed in claim 59, wherein said material is free of added chondrocytes. .Iaddend.

.Iadd.63. A cartilage defect repair material as claimed in claim 59, wherein said cartilage pieces are formed by freezing allograft cartilage with liquid nitrogen and milling the frozen cartilage. .Iaddend.

.Iadd.64. A cartilage defect repair material as claimed in claim 59, wherein said cartilage pieces are formed by freeze-milling allograft cartilage subsequent to lyophilization. .Iaddend.

.Iadd.65. A cartilage defect repair material for use in human beings, comprising lyophilized, freeze-milled allograft cartilage pieces having a size not greater than 1 mm, wherein said cartilage pieces are included in a mixture that also includes a bioabsorbable carrier, said cartilage pieces being present in said mixture at an amount within the range of from about 15% to about 30% by weight, and said bioabsorbable carrier being present in said mixture at an amount within the range of from about 70% to about 85% by weight. .Iaddend.

.Iadd.66. A cartilage defect repair material as claimed in claim 65, wherein said cartilage pieces are formed from allograft cartilage that has been lyophilized so as to reduce its water content to an amount within the range of from about 0.1% to about 8.0% by weight. .Iaddend.

.Iadd.67. A cartilage defect repair material as claimed in claim 65, wherein said size ranges from 0.01 mm to 1.0 mm. .Iaddend.

.Iadd.68. A cartilage defect repair material as claimed in claim 65, wherein said material is free of added chondrocytes. .Iaddend.

.Iadd.69. A cartilage defect repair material as claimed in claim 65, wherein said cartilage pieces are formed by freezing allograft cartilage with liquid nitrogen and milling the frozen cartilage. .Iaddend.

.Iadd.70. A cartilage defect repair material as claimed in claim 65, wherein said cartilage pieces are formed by freeze-milling allograft cartilage subsequent to lyophilization. .Iaddend.

.Iadd.71. A method of repairing a cartilage defect in a human being, comprising the step of placing in a defect site lyophilized, freeze-milled allograft cartilage pieces having a size not greater than 1 mm. .Iaddend.

.Iadd.72. A method as claimed in claim 71, wherein the cartilage pieces have a water content ranging from about 0.1% to about 8.0% by weight prior to their placement in the defect site. .Iaddend.

.Iadd.73. A method as claimed in claim 71, wherein the cartilage pieces are formed from allograft cartilage which has been lyophilized so as to reduce its water content to an amount within the range of from about 0.1% to about 8.0% by weight. .Iaddend.

.Iadd.74. A method as claimed in claim 71, wherein the size ranges from 0.01 mm to 1.0 mm. .Iaddend.

.Iadd.75. A method as claimed in claim 71, wherein the cartilage pieces are formed by freezing allograft cartilage with liquid nitrogen and milling the frozen cartilage. .Iaddend.

.Iadd.76. A method as claimed in claim 71, wherein the cartilage pieces are formed by freeze-milling allograft cartilage subsequent to lyophilization of the allograft cartilage. .Iaddend.

.Iadd.77. A method as claimed in claim 71, wherein the defect site includes a defect in articular cartilage. .Iaddend.

.Iadd.78. A method as claimed in claim 77, wherein the cartilage pieces have an ability to promote the growth of new articular cartilage in the articular cartilage defect. .Iaddend.

.Iadd.79. A method as claimed in claim 71, wherein the lyophilized, freeze-milled allograft cartilage pieces consist essentially of articular cartilage. .Iaddend.

.Iadd.80. A method as claimed in claim 71, wherein the lyophilized, freeze-milled allograft cartilage pieces lack cell viability. .Iaddend.

.Iadd.81. A method as claimed in claim 71, comprising the further steps of harvesting a donor tissue consisting essentially of articular cartilage, lyophilizing said donor tissue, and freeze-milling said donor tissue. .Iaddend.

.Iadd.82. A method as claimed in claim 71, comprising the further step of forming the lyophilized, freeze-milled allograft cartilage pieces by a process including the step of milling frozen allograft articular cartilage. .Iaddend.

.Iadd.83. A method as claimed in claim 71, wherein the lyophilized, freeze-milled allograft cartilage pieces are free of added chondrocytes. .Iaddend.

Details for Patent RE42208

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 001 2015-01-23   Start Trial Musculoskeletal Transplant Foundation (Edison, NJ) 2023-04-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 002 2015-01-23   Start Trial Musculoskeletal Transplant Foundation (Edison, NJ) 2023-04-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 003 2015-01-23   Start Trial Musculoskeletal Transplant Foundation (Edison, NJ) 2023-04-29 RX Orphan search
Nps Pharms Inc NATPARA parathyroid hormone INJECTABLE;INJECTION 125511 004 2015-01-23   Start Trial Musculoskeletal Transplant Foundation (Edison, NJ) 2023-04-29 RX Orphan search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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