Post irradiation shelf-stable dual paste direct injectable bone cement precursor systems and methods of making same
First Claim
1. A bone cement precursor system comprising:
- a first container containing an acidic aqueous paste comprising monocalcium phosphate monohydrate (MCPM) and dicalcium phosphate anhydrous (DCPA), citric acid, water, glycerol, polyvinyl pyrrolidone (PVP) and polyethylene glycol (PEG), anda second container containing an alkaline non-aqueous paste comprising at least one basic calcium phosphate mineral, at least one paste stabilizing agent, a surfactant and a solvent, wherein said at least one basic calcium phosphate mineral is tetra calcium phosphate (TTCP) having a bimodal mean particle size distribution, wherein the mean particle size of a first set of said TTCP is between about 10 μ
m to about 30 μ
m, and the mean particle size of a second set of the TTCP is between about 25 μ
m to about 60 μ
m.
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Accused Products
Abstract
The present invention relates to a bone cement precursor system that is presented in the form of two shelf-stable pastes which have been terminally sterilized and are held in separate containers during product transport and storage. When the product is used during surgery, these pastes inject to a site of application through a static mixing device by the action of applied injection force. When the two pastes are mixed, they start to react to each other while injecting out. The resulting composition is highly biocompatible, osteoconductive, injectable, rapid setting and bioresorbable, and is useful in connection with bone repair procedures, for example, in the craniomaxillofacial, trauma and orthopedic areas.
103 Citations
26 Claims
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1. A bone cement precursor system comprising:
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a first container containing an acidic aqueous paste comprising monocalcium phosphate monohydrate (MCPM) and dicalcium phosphate anhydrous (DCPA), citric acid, water, glycerol, polyvinyl pyrrolidone (PVP) and polyethylene glycol (PEG), and a second container containing an alkaline non-aqueous paste comprising at least one basic calcium phosphate mineral, at least one paste stabilizing agent, a surfactant and a solvent, wherein said at least one basic calcium phosphate mineral is tetra calcium phosphate (TTCP) having a bimodal mean particle size distribution, wherein the mean particle size of a first set of said TTCP is between about 10 μ
m to about 30 μ
m, and the mean particle size of a second set of the TTCP is between about 25 μ
m to about 60 μ
m. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A bone cement precursor system comprising:
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a first container containing an acidic aqueous paste comprising at least one acidic calcium phosphate mineral, at least one synthetic polymer-based paste stabilizing agent, a pH buffering agent and a humectant, and a second container containing an alkaline non-aqueous paste comprising tetracalcium phosphate (TTCP), polyethylene glycol (PEG), polysorbate 80, and propylene glycol, wherein said alkaline non-aqueous paste comprises a bimodal mean particle size distribution of the TTCP, wherein the mean particle size of a first set of said at least one TTCP mineral is between about 10 μ
m to about 30 μ
m, and the mean particle size of a second set of the at least one TTCP is between about 25 μ
m to about 60 μ
m. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24, 25, 26)
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Specification