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Kafe 바로가기국가/구분 | United States(US) Patent 등록 |
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국제특허분류(IPC7판) |
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출원번호 | US-0814033 (2010-06-11) |
등록번호 | US-9180224 (2015-11-10) |
발명자 / 주소 |
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출원인 / 주소 |
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대리인 / 주소 |
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인용정보 | 피인용 횟수 : 0 인용 특허 : 206 |
The invention provides a particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, including i) a calcium sulfate hemihydrate powder having a bimodal particle distribution and a median particle size of about 5 to about 20 microns, wherein the ca
The invention provides a particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, including i) a calcium sulfate hemihydrate powder having a bimodal particle distribution and a median particle size of about 5 to about 20 microns, wherein the calcium sulfate hemihydrate is present at a concentration of at least about 70 weight percent based on the total weight of the particulate composition; ii) a monocalcium phosphate monohydrate powder; and iii) a β-tricalcium phosphate powder having a median particle size of less than about 20 microns. Bone graft substitute cements made therefrom, a bone graft substitute kit comprising the particulate composition, methods of making and using the particulate composition, and articles made from the bone graft substitute cement are also provided.
1. A particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, comprising: i) an α-calcium sulfate hemihydrate powder wherein the calcium sulfate hemihydrate is present at a concentration of about 50 weight percent to about 90 weight percent bas
1. A particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, comprising: i) an α-calcium sulfate hemihydrate powder wherein the calcium sulfate hemihydrate is present at a concentration of about 50 weight percent to about 90 weight percent based on the total weight of the particulate composition; andii) a combination of two calcium phosphate powders capable of reacting to form brushite in the presence of an aqueous solution, wherein the combination of two calcium phosphate powders comprises monocalcium phosphate monohydrate powder and β-tricalcium phosphate powder. 2. The particulate composition of claim 1, wherein the β-tricalcium phosphate powder has a median particle size of less than about 20 microns. 3. The particulate composition of claim 2, wherein the β-tricalcium phosphate powder has a median particle size of less than about 18 microns. 4. The particulate composition of claim 3, wherein the β-tricalcium phosphate powder has a median particle size of less than about 15 microns. 5. The particulate composition of claim 1, wherein the β-tricalcium phosphate powder has a bimodal particle size distribution comprising about 30 to about 70 volume percent of particles having a mode of about 2.0 to about 6.0 microns and about 30 to about 70 volume percent of particles having a mode of about 40 to about 70 microns based on the total volume of the β-tricalcium phosphate powder. 6. The particulate composition of claim 5, wherein the β-tricalcium phosphate powder has a bimodal particle size distribution comprising about 50 to about 65 volume percent of particles having a mode of about 4.0 to about 5.5 microns and about 35 to about 50 volume percent of particles having a mode of about 60 to about 70 microns based on the total volume of the β-tricalcium phosphate powder. 7. The particulate composition of claim 1, wherein the monocalcium phosphate monohydrate powder and the β-tricalcium phosphate powder are present in approximately equimolar amounts. 8. The particulate composition of claim 1, wherein the monocalcium phosphate monohydrate powder is present at a concentration of about 3 to about 7 weight percent and the β-tricalcium phosphate powder is present at a concentration of about 3.72 to about 8.67 weight percent, based on the total weight of the particulate composition. 9. The particulate composition of claim 1, wherein the combination of two calcium phosphate powders are present at a concentration of about 3 to about 30 weight percent based on the total weight percent of the particulate composition. 10. The particulate composition of claim 9, wherein the combination of two calcium phosphate powders are present at a concentration of about 10 to about 20 weight percent based on the total weight percent of the particulate composition. 11. The particulate composition of claim 1, wherein the median particle size of the a-calcium sulfate hemihydrate powder is about 5 to about 20 microns. 12. The particulate composition of claim 11, wherein the median particle size of the α-calcium sulfate hemihydrate powder is about 8 to about 15 microns. 13. The particulate composition of claim 12, wherein the median particle size of the α-calcium sulfate hemihydrate powder is about 10 to about 15 microns. 14. The particulate composition of claim 1, wherein the α-calcium sulfate hemihydrate powder has a bimodal particle distribution comprising about 30 to about 60 volume percent of particles having a mode of about 1.0 to about 3.0 microns and about 40 to about 70 volume percent of particles having a mode of about 20 to about 30 microns, based on the total volume of the α-calcium sulfate hemihydrate powder. 15. The particulate composition of claim 14, wherein the α-calcium sulfate hemihydrate powder has a bimodal particle distribution comprising about 40 to about 60 volume percent of particles having a mode of about 1.0 to about 2.0 microns and about 40 to about 60 volume percent of particles having a mode of about 20 to about 25 microns, based on the total volume of the α-calcium sulfate hemihydrate powder. 16. The particulate composition of claim 1, wherein the α-calcium sulfate hemihydrate powder is present at a concentration of at least about 70 weight percent to about 90 weight percent based on the total weight of the particulate composition. 17. The particulate composition of claim 16, wherein the α-calcium sulfate hemihydrate powder is present at a concentration of at least about 75 weight percent to about 90 weight percent based on the total weight of the particulate composition. 18. The particulate composition of claim 1, further comprising a plurality of β-tricalcium phosphate granules. 19. The particulate composition of claim 18, wherein the β-tricalcium phosphate granules have a median particle size of at least about 75 microns. 20. The particulate composition of claim 19, wherein the β-tricalcium phosphate granules have a median particle size of about 75 to about 1,000 microns. 21. The particulate composition of claim 20, wherein the β-tricalcium phosphate granules have a median particle size of about 100 to about 400 microns. 22. The particulate composition of claim 21, wherein the β-tricalcium phosphate granules have a median particle size of about 180 to about 240 microns. 23. The particulate composition of claim 18, wherein the β-tricalcium phosphate granules are present at a concentration of up to about 20 weight percent based on the total weight of the particulate composition. 24. The particulate composition of claim 23, wherein the β-tricalcium phosphate granules are present at a concentration of up to about 15 weight percent based on the total weight of the particulate composition. 25. The particulate composition of claim 24, wherein the β-tricalcium phosphate granules are present at a concentration of up to about 12 weight percent based on the total weight of the particulate composition. 26. The particulate composition of claim 25, wherein the β-tricalcium phosphate granules are present at a concentration of about 8 to about 12 weight percent based on the total weight of the particulate composition. 27. The particulate composition of claim 1, further comprising an accelerant adapted for accelerating the conversion of calcium sulfate hemihydrate to calcium sulfate dihydrate. 28. The particulate composition of claim 27, wherein the accelerant is selected from the group consisting of calcium sulfate dihydrate particles, potassium sulfate particles, and sodium sulfate particles, wherein the accelerant is optionally coated with sucrose. 29. The particulate composition of claim 27, wherein the accelerant is present at a concentration of up to about 1 weight percent based on the total weight of the particulate composition. 30. The particulate composition of claim 1, further comprising a biologically active agent. 31. The particulate composition of claim 30, wherein the biologically active agent is an osteoinductive material. 32. The particulate composition of claim 31, wherein the osteoinductive material is demineralized bone matrix. 33. The particulate composition of claim 30, wherein the biologically active agent is a growth factor. 34. The particulate composition of claim 1, wherein the particulate composition sets to a hardened mass upon mixing with an aqueous solution in about 3 to about 25 minutes. 35. The particulate composition of claim 34, wherein the particulate composition sets to a hardened mass upon mixing with an aqueous solution in about 10 to about 20 minutes. 36. The particulate composition of claim 1, wherein all of the powder components of the particulate composition are in admixture. 37. The particulate composition of claim 1, wherein the powder components of the particulate composition are in one or more containers. 38. The particulate composition of claim 1, wherein the particulate composition further comprises a plurality of β-tricalcium phosphate granules having a median particle size greater than the particle size of the β-tricalcium phosphate powder. 39. The particulate composition of claim 1, wherein the particulate composition further comprises demineralized bone matrix. 40. A bone graft substitute cement comprising the reaction product formed by mixing a particulate composition according to claim 1 with an aqueous solution, the reaction product comprising calcium sulfate dihydrate and brushite. 41. The bone graft substitute cement of claim 40, wherein said cement exhibits a diametral tensile strength of at least about 6 MPa after curing for one hour in ambient air following mixing of the particulate composition with the aqueous solution. 42. The bone graft substitute cement of claim 40, wherein said cement exhibits a diametral tensile strength of at least about 10 MPa after curing for 24 hours in ambient air following mixing of the particulate composition with the aqueous solution. 43. The bone graft substitute cement of claim 40, wherein said cement exhibits a compressive strength of at least about 40 MPa after curing for one hour in ambient air following mixing of the particulate composition with the aqueous solution. 44. The bone graft substitute cement of claim 40, wherein said cement exhibits a compressive strength of at least about 80 MPa after curing for 24 hours in ambient air following mixing of the particulate composition with the aqueous solution. 45. The bone graft substitute cement of claim 40, wherein the aqueous solution comprises a carboxylic acid. 46. The bone graft substitute cement of claim 45, wherein the carboxylic acid is a hydroxy carboxylic acid. 47. The bone graft substitute cement of claim 46, wherein the hydroxy carboxylic acid is glycolic acid. 48. The bone graft substitute cement of claim 45, wherein the carboxylic acid is neutralized to a pH of about 6.5 to about 7.5. 49. The bone graft substitute cement of claim 40, wherein the aqueous solution is mixed with the particulate composition in an amount necessary to achieve a liquid to powder mass ratio of at least about 0.2. 50. The bone graft substitute cement of claim 40, wherein the bone graft substitute cement is injectable prior to setting into a hardened form. 51. A bone graft substitute kit, comprising one or more containers enclosing a radiation-sterilized particulate composition according to claim 1, and a separate container enclosing a radiation-sterilized aqueous solution. 52. The bone graft substitute kit of claim 51, further comprising one or more of the following: a written instruction set describing a method of using said kit;a mixing apparatus adapted for mixing the particulate composition and the aqueous solution; anda delivery device adapted for delivering a bone graft substitute cement mixture to the site of a bone defect. 53. A method for treating a bone defect, comprising applying a bone graft substitute cement according to claim 40 to the site of the bone defect. 54. A method for preparing an orthopedic implant for implantation, comprising applying a bone graft substitute cement according to claim 40 to the orthopedic implant. 55. The method of claim 54, wherein the orthopedic implant is a joint replacement device. 56. The method of claim 55, wherein the joint replacement device is selected from the group consisting of knee replacement devices, hip replacement devices, elbow replacement devices, upper femoral devices, upper humeral devices, wrist replacement devices, shoulder devices, passive tendon devices, spinal devices, finger/toe devices, and diaphysis devices. 57. A bone graft substitute cement comprising a mixture of a calcium sulfate dihydrate phase characterized by a first in vivo resorption rate, a brushite phase characterized by a second in vivo resorption rate slower than the first in vivo resorption rate; and a β-tricalcium phosphate granule phase characterized by a third in vivo resorption rate slower than the second in vivo resorption rate, wherein the cement is formed by mixing a particulate composition with an aqueous solution, wherein the particulate composition includes an α-calcium sulfate hemihydrate powder, and a combination of two calcium phosphate powders, wherein the combination of two calcium phosphate powders comprises monocalcium phosphate monohydrate powder and β-tricalcium phosphate powder, and wherein the α-calcium sulfate hemihydrate is present at a concentration of about 50 weight percent to about 90 weight percent based on the total weight of the particulate composition. 58. The bone graft substitute cement of claim 57, wherein the bone graft substitute cement is injectable prior to setting into a hardened form. 59. A bone graft substitute kit, comprising: a sterilized particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, wherein the particulate composition comprises i) an α-calcium sulfate hemihydrate powder, wherein the calcium sulfate hemihydrate is present at a concentration of about 50 weight percent to about 90 weight percent based on the total weight of the particulate composition; and ii) a combination of two calcium phosphate powders capable of reacting to form brushite in the presence of an aqueous solution, wherein the combination of two calcium phosphate powders comprises monocalcium phosphate monohydrate powder and β-tricalcium phosphate powder, wherein the two calcium phosphate powders are stored separate from each other in the kit; anda sterilized aqueous solution comprising a carboxylic acid dissolved therein stored separately from the particulate composition in the kit. 60. The bone graft substitute kit of claim 59, wherein the aqueous solution and the particulate composition are both radiation sterilized. 61. The bone graft substitute kit of claim 59, further comprising one or more of the following: a written instruction set describing a method of using said kit;a mixing apparatus adapted for mixing the particulate composition and the aqueous solution; anda delivery device adapted for delivering a bone graft substitute cement mixture to the site of a bone defect. 62. A method for treating a bone defect, comprising: mixing a particulate composition with an aqueous solution to form a bone graft substitute cement, wherein the particulate composition comprises an α-calcium sulfate hemihydrate powder and a combination of two calcium phosphate powders capable of reacting to form brushite in the presence of an aqueous solution, wherein the combination of two calcium phosphate powders comprises monocalcium phosphate monohydrate powder and β-tricalcium phosphate powder wherein the calcium sulfate hemihydrate is present at a concentration of about 50 weight percent to about 90 weight percent based on the total weight of the particulate composition; and applying the bone graft substitute cement to the bone defect. 63. The method of claim 62, wherein the applying step comprises injecting the bone graft substitute cement into the bone defect. 64. The method of claim 62, wherein the bone graft substitute cement comprises a mixture of a calcium sulfate dihydrate phase characterized by a first in vivo resorption rate and a brushite phase characterized by a second in vivo resorption rate slower than the first in vivo resorption rate. 65. The method of claim 64, wherein the particulate composition further comprises a plurality of β-tricalcium phosphate granules such that the β-tricalcium phosphate granules provide a third in vivo resorption rate slower than the second in vivo resorption rate. 66. The method of claim 62, wherein the particulate composition further comprises a plurality β-tricalcium phosphate granules having a median particle size greater than the particle size of the β-tricalcium phosphate powder. 67. The method of claim 62, wherein the particulate composition further comprises demineralized bone matrix. 68. The method of claim 62, wherein the aqueous solution is mixed with the particulate composition in an amount necessary to achieve a liquid to powder mass ratio of at least about 0.2. 69. The method of claim 62, wherein the cement exhibits a diametral tensile strength of at least about 6 MPa after curing for one hour in ambient air following mixing of the particulate composition with the aqueous solution. 70. The method of claim 62, wherein the cement exhibits a diametral tensile strength of at least about 10 MPa after curing for 24 hours in ambient air following mixing of the particulate composition with the aqueous solution. 71. The method of claim 62, wherein the cement exhibits a compressive strength of at least about 40 MPa after curing for one hour in ambient air following mixing of the particulate composition with the aqueous solution. 72. The method of claim 62, wherein the cement exhibits a compressive strength of at least about 80 MPa after curing for 24 hours in ambient air following mixing of the particulate composition with the aqueous solution. 73. The method of claim 62, wherein the aqueous solution comprises a carboxylic acid. 74. The method of claim 73, wherein the carboxylic acid is a hydroxy carboxylic acid. 75. The method of claim 74, wherein the hydroxy carboxylic acid is glycolic acid. 76. The method of claim 73, wherein the carboxylic acid is neutralized to a pH of about 6.5 to about 7.5. 77. The method of claim 62, wherein application of the bone graft substitute cement results in new bone formation at the site of the bone defect characterized by a yield strength greater than normal bone at 13 weeks after application of the bone graft substitute cement.
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