Pore-forming agent for the orthopedic cement 机翻标题: 暂无翻译,请尝试点击翻译按钮。

公开号/公开日
JP2005508217 A 2005-03-31 [JP2005508217] / 2005-03-31
申请号/申请日
2003JP-0528218 / 2002-09-20
发明人
Dararu Pareshiesu;You Lander Jay Tracy;Toss Carol Ann;Kurukani shy Resch Sea;
申请人
STRYKER;
主分类号
IPC分类号
A01N-043/04A01N-063/00A61BA61F-002/00A61F-013/00A61L-027/00A61L-027/12A61L-027/22A61L-027/56C07K-014/47C08J-009/26C08J-009/28
摘要
(JP2005508217) A bone precursor composition comprising a cement mixture and a pore-forming agent is provided for bone implant.  Preferably, the pore-forming agent has a particle size of 20-500 mu m.  More preferably, the proportion of the pore-forming agent is 7-40% (w/w).  The composition may further include a bioactive agent, preferably a bone morphogenic protein or nucleic acid encoding BMP encapsulated in the pore-forming agent.  The moldability of the composition can be modulated by the addition of a binder.  The invention provides a kit and implant device comprising the bone precursor composition.  The invention also provides an implantable prosthetic device comprising a prosthetic implant having a surface region and a bone precursor material disposed on the surface region.  The kit and devices may further comprise one or more additional components including a bioactive agent and a binder.  Methods of inducing bone formation and delivering the bioactive agent are provided.  (From WO03024316 A3)
机翻摘要
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地址
代理人
代理机构
;
优先权号
2001US-09960421 2001-09-21 2002WO-US29966 2002-09-20
主权利要求
(JP2005508217) 1. Including a cement mixture and a pore-forming agents in the bone precursor composition, and the pore-forming agent, has a particle size of 20-500μm; however, the pore-forming agent when PLGA, the particle size and 20-140μm or 310-500μm, then the pore-forming agent is calcium sulfate when, the particle size is in 260-500μm 20-140μm or, the bone precursor composition.  2. The pore-forming agent has a particle size of 20-140μm, comprising a cement mixture and a pore-forming agents, bone precursor composition.  3. The pore-forming agent has a particle size of 75-140μm, comprising a cement mixture and a pore-forming agent, the bone precursor composition.  4. The ratio of the pore-forming agent (w/w) at 7-40%, according to any one of claims 1-3 LABORATORYMANLIAL, bone precursor composition.  5. The ratio of the pore-forming agent is 7-25% (w/w), as set forth in any one of claims 1-3, bone precursor composition.  6. Wherein the ratio of the pore-forming agent (w/w) and 7-14%, then the pore-forming agent is PLGA, as described in any one of claims claims 1-3, bone precursor composition.  7. Wherein the calcium phosphate cement mixture and the cement mixture is calcium sulfate cement mixture is selected from the group consisting of a mixture, either one of the claims 1-3 LABORATORYMANLIAL, bone precursor composition.  8. Wherein the cement mixture is selected from the group consisting of the following mixtures, according to any one of claims 1-3 LABORATORYMANLIAL, bone precursor composition: (a) the decarbonated amorphous calcium phosphate and 2 of the first mixture of calcium phosphate; 2 (b) a mixture of tetracalcium phosphate and calcium phosphate; monocalcium (c), a mixture of tetracalcium phosphate and calcium carbonate; β - tricalcium phosphate and calcium phosphate monohydrate (d) a mixture of, and optionally calcium pyrophosphate, calcium sulfate dihydrate, and mixtures comprising calcium sulfate hemihydrate; β - (e) tetracalcium phosphate, dicalcium phosphate dihydrate and mixtures of the calcium carbonate; (f) and calcium sulfate hemihydrate.  9. 2 The second calcium phosphate, monocalcium, phosphate anhydrous, dicalcium phosphate dihydrate phosphate is, Hepta-calcium phosphate, calcium pyrophosphate, octacalcium α -, β - tricalcium phosphate, phosphate and amorphous calcium phosphate is selected from the group consisting of, as described in claim 8, bone precursor composition.  10. Wherein the pore-forming agent is a natural or synthetic biodegradable polymer is a polymer containing an acid-decomposable bioavailabilities, according to any one of claims 1-3 LABORATORYMANLIAL, bone precursor composition.  11. Wherein the pore-forming agent is ethylene-vinyl acetates, natural and synthetic collagen, poly (Gurukisanon), poly (fasufazen), polyglactin, polyglactin acid, polyglactic acid, polyacrylic acid, Poly Aku Kano benzoate, polyorthoesters, poly (lactide-co-L -) (PLLA), poly (D, L- lactide) (PDLLA), polyglycolide (PGA), poly (lactide - co - glycolide) (PLGA), poly (ζ - caprolactone), poly (trimethylene carbonate), poly (p - dioxanone), poly (glycolide - co - ζ - caprolactone), poly (glycolide - co - trimethylene carbonate), poly (D, L- lactide - co - trimethylene carbonate), polyarylates, polyhydroxybutyrate (PHB), poly anhydride, poly (anhydride - co - imide) and copolymers thereof, amino acid polymers, - co - propylene fumarate, α - 1 - one or more hydroxy carboxylic acid monomer polymer, calcium sulfate, bioactive glass compositions, and mixtures thereof as well as any derivative thereof selected from the group consisting of variant; however, wherein the cement mixture when the calcium sulfate hemihydrate, the pore-forming agent is not calcium sulfate, according to any one of claims 1-3 LABORATORYMANLIAL, bone precursor composition.  12. Wherein the PLGA has a molecular weight of 5kD - 100kD, as described in claim 11, bone precursor composition.  13. Wherein the PLGA has a molecular weight of 10kD - 30kD, as described in claim 11, bone precursor composition.  14. Wherein the cement mixture comprises a mixture of tetracalcium phosphate and phosphate anhydrous; then, PLGA and the pore-forming agent is selected from the group consisting of calcium sulfate, described according to any one of claims 1-3, bone precursor composition.  15. Wherein the cement mixture comprises calcium sulfate hemihydrate, the pore-forming agent is PLGA, according to any one of claims 1-3 LABORATORYMANLIAL, bone precursor composition.  16. Further comprising a bioactive agent, as described in any one of claims 1-3, bone precursor composition.  17. Wherein the bioactive agent is bone morphogenic protein, as described in claim 16, bone precursor composition.  18. Wherein the bioactive factor is a bone morphogenic protein is a nucleic acid molecule comprising a sequence encoding, as described in claim 16, bone precursor composition.  19. Wherein said bone morphogenic protein OP-1, OP-2, OP-3, COP-1, COP-3, COP-4, COP-5, COP-7, COP-16, BMP-2, BMP-3, BMP-3b, BMP-4, BMP-5, BMP-6, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, GDF-1, GDF-2, GDF-3, GDF-5, GDF-6, GDF-7, GDF-8, GDF-9, GDF-10, GDF-11, GDF-12, MP121, -1 Dosarin, DPP, Vg-1, Vgr-1,60A protein, NODAL, UNIVIN, SCREW, ADMP, NEURAL, TGF-β and bone formation activity thereof having conservative amino acid sequence variants is selected from the group consisting of, as described in claim 17 bone precursor composition.  20. Wherein the biological activity of human OP-1 C-terminus of the amino acids 102-106, 70% having a homology of at least an osteogenic protein comprising the amino acid sequence, as described in claim 16 bone precursor composition.  21. Wherein the bioactive agent is encapsulated in the pore-forming agent, as described in claim 16 bone precursor composition.  22. Further comprising a binder, as described in any one of claims 1-3 bone precursor composition.  23. The binding agent is sodium alginate, hyaluronic acid, sodium hyaluronate, gelatin, peptides, mucin, chondroitin sulfate, chitosan, poloxamer, glycosaminoglycans, polysaccharides, polyethylene glycol, methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxybutylmethyl cellulose, hydroxyethyl methylcellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, hydroxyethylcellulose, mannitol, white petrolatum, mannitol/dextran combinations, mannitol/white petrolatum combinations, sesame oil, fibrin glue, blood and mixtures thereof is selected from the group consisting of, described in claim 22, bone precursor composition.  24. Claims 1-3 implantable described in any one of the bone precursor composition.  25. A composition comprising a solid cement and a pore-forming agent, and the pore-forming agent has a particle size of 20-500μm; however, the pore-forming agent when PLGA, the particle size and 20-140μm or 310-500μm, pore-forming agent is calcium sulfate and when, the particle size is 20-140μm or 260-500μm, composition.  26. The pore-forming agent has a particle size of 20-140μm, a composition comprising a solid cement and a pore-forming agent.  27. 75-140μm pore-forming agent has a particle size, a composition comprising a solid cement and the pore-forming agent.  28. The ratio of the pore-forming agent is 7-40% (w/w), according to any one of claims 25-27 compositions.  29. Wherein the ratio of the pore-forming agent is 7-25% (w/w), according to any one of claims 25-27 compositions.  30. The pore-forming agent is PLGA, (w/w) and the ratio is at 7-14%, according to any one of claims 25-27 compositions.  31. Wherein the calcium phosphate solid cement is selected from the group consisting of a calcium sulfate containing cement, according to any one of claims 25-27 composition described.  32. Wherein the pore-forming agent is natural biodegradable polymer or a copolymer of synthetic biodegradable polymer is a polymer, according to any one of claims 25-27 composition described.  33. Wherein the pore-forming agent is ethylene-vinyl acetates, natural and synthetic collagen, poly (Gurakisanon), poly (phosphazene), polyglactin, polyglactin acid, polyglactic acid, polyacrylic acid, poly alkanoate, polyorthoesters, poly (lactide-co-L -) (PLLA), poly (D, L- lactide) (PDLLA), polyglycolide (PGA), poly (lactide - co - glycolide) (PLGA), poly (caprolactone ζ -), poly (trimethylene carbonate), poly (p - dioxanone), poly (glycolide - co - ζ - caprolactone), poly (glycolide - co - trimethylene carbonate), poly (D, L- lactide - co - trimethylene carbonate), polyarylates, polyhydroxybutyrate (PHB), poly anhydride, poly (anhydride - co - imide) and copolymers thereof, amino acid polymers, - co - propylene fumarate, α - 1 - one or more hydroxy carboxylic acid monomer polymer, calcium sulfate, bioactive glass compositions, and mixtures thereof as well as any derivative thereof selected from the group consisting of variant; however, wherein the cement mixture is calcium sulfate hemi-hydrate and, and the pore-forming agent is not calcium sulfate, according to any one of claims 25-27 compositions.  34. Wherein the PLGA has a molecular weight of 5kD - 100kD, the composition as described in claim 33.  35. Wherein the PLGA has a molecular weight of 10kD - 30kD, the composition as described in claim 33.  36. A kit comprising the following: (a) according to any one of claims 1-3 wherein said bone precursor composition; and (b) a bioactive agent.  37. Wherein the bioactive agent is bone morphogenic protein, claim 36 kit.  38. Wherein the bioactive factor is a bone morphogenic protein is a nucleic acid molecule comprising a sequence encoding, claim 36 kit.  39. Wherein said bone morphogenic protein, OP-1, OP-2, OP-3, COP-1, COP-3, COP-4, COP-5, COP-7, COP-16, BMP-2, BMP-3, BMP-3b, BMP-4, BMP-5, BMP-6, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, GDF-1, GDF-2, GDF-3, GDF-5, GDF-6, GDF-7, GDF-8, GDF-9, GDF-10, GDF-11, GDF-12, MP121, -1 Dosarin, DPP, Vg-1, Vgr-1,60A protein, NODAL, UNIVIN, SCREW, ADMP, NEURAL, TGF-β and bone formation activity thereof having conservative amino acid sequence variants is selected from the group consisting of, claim 37 kit.  40. A bioactive agent of human OP-1 C-terminus of the amino acids 102-106, having a homology of at least 70% is an osteogenic protein comprising the amino acid sequence, as described in claim 36 kit.  41. A kit comprising the following: (a) according to any one of claims 1-3 bone precursor composition described; and (b) binding agent.  42. The binding agent is sodium alginate, hyaluronic acid, sodium hyaluronate, gelatin, peptides, mucin, chondroitin sulfate, chitosan, poloxamer, glycosaminoglycans, polysaccharides, polyethylene glycol, methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxybutylmethyl cellulose, hydroxyethylmethyl cellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, hydroxyethylcellulose, mannitol, white petrolatum, mannitol/dextran combinations, mannitol/white petrolatum combinations, sesame oil, fibrin glue, blood and mixtures thereof is selected from the group consisting of, kit of claim 41.  43. An implantable prosthetic device comprising the following: (a) adjacent to a target tissue, the implantable prosthetic implant having a surface area; and (b) are arranged in a surface area, according to any one of claims 1-3 LABORATORYMANLIAL bone precursor composition.  44. Further, wherein said bone precursor composition including a bioactive agent dispersed in, as described in claim 43 prosthetic device.  45. Wherein the bioactive agent is bone morphogenic protein, as recited in claim 44 prosthetic device.  46. Wherein the bioactive factor is a bone morphogenic protein is a nucleic acid molecule comprising a sequence encoding, as described in claim 44 prosthetic device.  47. Wherein said bone morphogenic protein OP-1, OP-2, OP-3, COP-1, COP-3, COP-4, COP-5, COP-7, COP-16, BMP-2, BMP-3, BMP-3b, BMP-4, BMP-5, BMP-6, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, GDF-1, GDF-2, GDF-3, GDF-5, GDF-6, GDF-7, GDF-8, GDF-9, GDF-10, GDF-11, GDF-12, MP121, -1 Dosarin, DPP, Vg-1, Vgr-1,60A protein, NODAL, UNIVIN, SCREW, ADMP, NEURAL, TGF-β and bone-forming activity thereof having conservative amino acid sequence variants of the selected from the group consisting of, claim 45 prosthetic device.  48. A bioactive agent C of human OP-1 and amino acids 102-106 of the distal end, having a homology of at least 70% is an osteogenic protein comprising the amino acid sequence, as described in claim 44 prosthetic device.  49. Wherein the device is a hip, fusion cage and a maxillofacial device is selected from the group consisting of, claim 43 prosthetic device.  50. Wherein said bioactive agent is encapsulated in the pore-forming agent, as described in claim 43 prosthetic device.  51. Further comprising a binder, a prosthetic device as described in claim 43.  52. The binding agent is sodium alginate, hyaluronic acid, sodium hyaluronate, gelatin, peptides, mucin, chondroitin sulfate, chitosan, poloxamer, glycosaminoglycans, polysaccharides, polyethylene glycol, methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose, hydroxypropylmethyl cellulose, hydroxybutylmethyl cellulose, hydroxyethylmethyl cellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, hydroxyethylcellulose, mannitol, white petrolatum, mannitol/dextran combinations, mannitol/white petrolatum combinations, sesame oil, fibrin glue, blood and mixtures thereof is selected from the group consisting of, described in claim 51 prosthetic device.  53. According to any one of claims 1-3 described composition comprising the bone precursor composition to the defect site of a mammal comprising the step of implanting, in a mammal in a method for inducing bone formation.  54. Wherein said composition further comprises a bioactive agent, the method described in claim 53.  55. Wherein the bioactive agent is bone morphogenic protein, the method described in claim 54.  56. Wherein said composition further comprises a bonding agent, the method described in claim 53.  57. Claims 1-3 according to any one of the bone precursor composition comprises a composition comprising a bioactive agent at a defect site of a mammal comprising the step of implanting, the formation of bone bioactive agent to the site in need to a method of delivering.  58. Wherein the bioactive agent is bone morphogenic protein, to the method described in claim 57.  59. Wherein the bioactive agent is encapsulated in the pore-forming agent, the method described in claim 57.  60. Wherein the delivery of the bioactive agent is sustained released, according to the method recited in claim 59.  61. Wherein the bioactive agent is bone morphogenic protein and a nucleic acid molecule comprising a sequence encoding, according to the method recited in claim 57.
法律状态
(JP2005508217) LEGAL DETAILS FOR JP2005508217  Actual or expected expiration date=2008-11-10    Legal state=DEAD    Status=REVOKED     Event publication date=2002-09-20  Event code=JP/APP  Event indicator=Pos  Event type=Examination events  Application details  Application country=JP JP2003528218  Application date=2002-09-20  Standardized application number=2003JP-0528218     Event publication date=2005-03-31  Event code=JP/A  Event indicator=Pos  Event type=Examination events  Published application  Publication country=JP  Publication number=JP2005508217  Publication stage Code=A  Publication date=2005-03-31  Standardized publication number=JP2005508217     Event publication date=2008-02-06  Event code=JP/A131  Event indicator=Neg  Event type=Examination events  Notification of reasons for refusal  Effective date of the event=2008-02-05  JAPANESE INTERMEDIATE CODE: A131     Event publication date=2008-05-02  Event code=JP/A601  Event type=Examination events  Written request for extension of term  Effective date of the event=2008-05-01  JAPANESE INTERMEDIATE CODE: A601     Event publication date=2008-05-13  Event code=JP/A602  Event type=Examination events  Written permission of extension of term  Effective date of the event=2008-05-12  JAPANESE INTERMEDIATE CODE: A602     Event publication date=2008-06-05  Event code=JP/A601  Event type=Examination events  Written request for extension of term  Effective date of the event=2008-06-04  JAPANESE INTERMEDIATE CODE: A601     Event publication date=2008-06-12  Event code=JP/A602  Event type=Examination events  Written permission of extension of term  Effective date of the event=2008-06-11  JAPANESE INTERMEDIATE CODE: A602     Event publication date=2008-07-02  Event code=JP/A601  Event type=Examination events  Written request for extension of term  Effective date of the event=2008-07-01  JAPANESE INTERMEDIATE CODE: A601     Event publication date=2008-07-09  Event code=JP/A602  Event type=Examination events  Written permission of extension of term  Effective date of the event=2008-07-08  JAPANESE INTERMEDIATE CODE: A602     Event publication date=2008-08-06  Event code=JP/A521  Event type=Restitution or restoration  Written amendment  Effective date of the event=2008-08-05  JAPANESE INTERMEDIATE CODE: A523     Event publication date=2008-11-11  Event code=JP/A02  Event indicator=Neg  Event type=Event indicating Not In Force  Decision of refusal  Effective date of the event=2008-11-10  JAPANESE INTERMEDIATE CODE: A02
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