Bone graft composition comprising a bone material and a carrier comprising denatured demineralized bone
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61F-002/28
A61K-035/32
출원번호
UP-0407409
(2006-04-19)
등록번호
US-7670384
(2010-04-21)
발명자
/ 주소
Kumar, Mukesh
Hamman, Ned M.
Leach, Michael D.
Manocchio, John
D'Antonio, Paul
Carter, Daryl L.
출원인 / 주소
Biomet Manufacturing Corp.
대리인 / 주소
Harness, Dickey & Pierce, P.L.C.
인용정보
피인용 횟수 :
22인용 특허 :
44
초록▼
Formed compositions for application to a bone surface of a human or animal subject, comprising: a bone material; and a carrier comprising denatured demineralized bone, where the composition is formed into a shape suitable for administration to the bone. Methods are provided for making formed composi
Formed compositions for application to a bone surface of a human or animal subject, comprising: a bone material; and a carrier comprising denatured demineralized bone, where the composition is formed into a shape suitable for administration to the bone. Methods are provided for making formed compositions for application to a bone surface of a human or animal subject comprise mixing a demineralized bone and water; heating the mixture to form a carrier; mixing the carrier with bone to form a moldable composition; and molding the moldable composition to produce a formed composition. Several apparatuses are provided in which to hydrate the formed bone composition. Methods of hydrating a formed bone composition are also provided.
대표청구항▼
What is claimed is: 1. A rigid formed composition for application to a bone surface of a human or animal subject, the rigid formed composition being made by drying a paste composition prior to application to the subject, the paste consisting of: (a) a first component that is a bone material selecte
What is claimed is: 1. A rigid formed composition for application to a bone surface of a human or animal subject, the rigid formed composition being made by drying a paste composition prior to application to the subject, the paste consisting of: (a) a first component that is a bone material selected from the group consisting of bone powder, bone chips, bone shavings, and mixtures thereof; and (b) a second component that is a carrier, wherein the carrier is denatured demineralized bone material; wherein the composition is formed into a rigid shape suitable for administration to the bone, wherein the shape is selected from a sheet, a patch, a block, a ring, a disc, a cylinder, or a shape for a specific site. 2. The formed composition according to claim 1, wherein the first component bone material is demineralized bone powder. 3. The formed composition according to claim 2, wherein the first component bone material has a particle size of less than 1000 microns. 4. The formed composition according to claim 3, wherein the first component bone material has a particle size of less than 850 microns. 5. A rigid formed composition for application to a bone surface of a human or animal subject the rigid formed composition being made by drying a paste composition prior to application to the subject, the paste consisting of: (a) a first component that is a bone material that is a mixture of bone powder and bone chips; and (b) a second component that is a carrier, wherein the carrier is denatured demineralized bone material; wherein the composition is formed into a rigid share suitable for administration to the bone, wherein the shape is selected from a sheet, a patch, a block, a ring, a disc, a cylinder, or a shape for a specific site. 6. The formed composition according to claim 5, wherein the large dimension of the demineralized bone chips is from about 750 to about 2000 microns. 7. The formed composition according to claim 6, wherein the large dimension is from about 750 to about 1500 microns. 8. The formed composition according to claim 1, wherein from about 10% to about 40% of the composition is first component bone material. 9. The formed composition according to claim 8, wherein from about 20% to about 30% of the composition is first component bone material. 10. The formed composition according to claim 1, wherein the carrier is made of denatured demineralized bone in an amount of from about 0.2% to about 40% by weight of carrier. 11. The formed composition according to claim 10, wherein the carrier is made of denatured demineralized bone in an amount of from about 0.5% to about 25% by weight of carrier. 12. The formed composition according to claim 1, wherein the carrier is made of denatured demineralized bone in an amount of from about 10% to about 20% by weight of carrier. 13. The formed composition according to claim 1, wherein the carrier is made by a process comprising: (a) mixing demineralized bone powder with water; and (b) heating the mixture of the powder and water under pressure. 14. The formed composition according to claim 13, wherein the heating is autoclaving the mixture. 15. A rigid formed composition for application to a bone surface of a human or animal subject the rigid formed composition being made by drying a paste composition prior to application to the subject, the paste consisting of: (a) a first component that is a bone material selected from the group consisting of bone powder, bone chips, bone shavings, and mixtures thereof; (b) a second component that is a carrier, wherein the carrier is denatured demineralized bone material; wherein the composition is formed into a rigid share suitable for administration to the bone, wherein the shape is selected from a sheet, a patch, a block, a ring, a disc, a cylinder, or a shape for a specific site; and (c) a third component that is a bone building material. 16. The formed composition according to claim 15, wherein the bone building material is selected from the group consisting of: calcium-containing ceramic materials, nutrient factors, bone morphogenic proteins, growth factors, antimicrobials, anti-inflammatory agents, blood products, and mixtures thereof. 17. The formed composition according to claim 16, wherein the bone building material is a calcium-containing ceramic material. 18. The formed composition according to claim 16, wherein the bone building material is a bone morphogenic protein, a growth factor, or mixtures thereof. 19. The formed composition according to claim 16, wherein the bone building material is a blood product. 20. The formed composition according to claim 1, wherein the shape is a patch. 21. The formed composition according to claim 1, wherein the bone material and the denatured demineralized bone are autologous with the subject. 22. A method for making a rigid formed composition for application to a bone surface of a human or animal subject, the composition being made rigid by drying prior to application to the subject, the method consisting of: (a) mixing a demineralized bone material and water; (b) heating the mixture of demineralized bone material and water to form a carrier and to denature the demineralized bone; (c) mixing the carrier with a second bone material to form a moldable composition, wherein the second bone material is selected from the group consisting of: bone powder, bone chips, bone shavings, and mixtures thereof; (d) molding the moldable composition to produce a formed composition having a shape suitable for administration to the bone; and (e) drying the formed composition to provide the rigid formed composition. 23. The method according to claim 22, wherein the second bone material is demineralized bone powder. 24. The method according to claim 23, wherein the demineralized bone powder has a particle size of less than about 850 microns. 25. A method according to claim 22, wherein the second bone material consists of demineralized bone powder and demineralized bone chips. 26. The method according to claim 22, wherein from about 20% to about 30% of the rigid formed composition is the second bone material. 27. The method according to claim 22, wherein the carrier is from about 10% to about 20% by weight of denatured demineralized bone. 28. A method for making a rigid formed composition for application to a bone surface of a human or animal subject, the composition being made rigid by driving prior to application to the subject, the method consisting of: (a) mixing a demineralized bone material and water; (b) heating the mixture of demineralized bone material and water to form a carrier and to denature the demineralized bone; (c) mixing the carrier with a second bone material, wherein the second bone material is selected from the group consisting of: bone powder, bone chips, bone shavings and mixtures thereof, and a third component that is a bone building material to form a moldable composition; (d) molding the moldable composition to produce a formed composition having a shape suitable for administration to the bone; and (e) drying the formed composition to provide the rigid formed composition. 29. The method according to claim 28, wherein the bone building material is a calcium-containing ceramic material. 30. The method according to claim 28, wherein the bone building material is a bone morphogenic protein, a growth factor, or mixtures thereof. 31. The method according to claim 22, wherein the rigid formed composition has a shape that is a patch, a block, or a shape for a specific site. 32. The method according to claim 22, wherein the second bone material and the demineralized bone are from a single donor. 33. The method according to claim 32, wherein the donor is the subject. 34. The method according to claim 22, wherein the heating is autoclaving the mixture. 35. The method according to claim 34, wherein the autoclaving is conducted at a temperature of from about 100° C. to about 150° C., and at a pressure of from about 10 psi to about 20 psi, for from about 60 mm to about 2 hours. 36. The method according to claim 22, wherein the drying technique is selected from the group consisting of lyophilizing, vacuum drying, air drying, temperature flux drying, and molecular sieve drying. 37. The method according to claim 36, wherein the drying technique is lyophilizing. 38. A method for making a rigid formed composition for application to a bone surface of a human or animal subject, the composition being made rigid by drying prior to application to the subject, the method consisting of: (a) mixing a demineralized bone material and water; (b) heating the mixture of demineralized bone material and water to form a carrier and to denature the demineralized bone; (c) mixing the carrier with a second bone material to form a moldable composition, wherein the second bone material is selected from the group consisting of: bone powder, bone chips, and mixtures thereof; (d) molding the moldable composition to produce a formed composition having a shape suitable for administration to the bone; (e) driving the formed composition to provide the rigid formed composition by lyophilization; and (f) packaging the composition after lyophilizing in a substantially air-impermeable package. 39. The method according to claim 38, wherein the package is made of a material selected from the group consisting of: thermoplastic films, polyester films, para-aramid fibers, polyethylene fibers, and combinations thereof. 40. A rigid formed composition for application to a bone surface of a human or animal subject made by the method of claim 22. 41. The rigid formed composition of claim 40, wherein the moldable composition is dried using a drying technique selected from the group consisting of lyophilizing, vacuum drying, air drying, temperature flux drying, and molecular sieve drying. 42. The rigid formed composition of claim 41 wherein the composition is packaged after drying in a substantially air-impermeable package that is made of a material selected from the group consisting of: thermoplastic films, polyester films, para-aramid fibers, polyethylene fibers, and combinations thereof. 43. A rigid formed composition for application to a bone surface of a human or animal subject, the rigid formed composition being made by drying a paste composition prior to application to the subject, the paste consisting of: (a) a first component that is a bone material selected from the group consisting of bone powder, bone chips, bone shavings, and mixtures thereof; and (b) a second component that is a carrier, wherein the carrier is denatured demineralized bone material; wherein the composition is formed into a rigid trough shape suitable for administration to the bone, and wherein the trough has at least one channel. 44. The rigid formed composition according to claim 43, wherein the trough has two channels. 45. The rigid formed composition according to claim 43, wherein at least one channel contains a bone building material.
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