Composition for an injectable bone mineral substitute material

Abstract

The invention refers to an injectable composition for a bone mineral substitute material, which comprises a dry powder mixed with an aqueous liquid. The powder comprises a first reaction component comprising a calcium sulphate hemihydrate with the capability of being hardened to calcium sulphate dihydrate when reacting with said aqueous liquid; a second reaction component, which comprises a calcium phosphate with the capability of being hardened to a calcium phosphate cement when reacting with said aqueous liquid; and at least one accelerator for the reaction of said first and/or second reaction component with said aqueous liquid. A method of producing an injectable bone mineral substitute material is also provided, wherein the composition is mixed in a closed mixing and delivery system for delivery.

1 - 33 . (canceled) 
     
     
         34 . A method of producing an injectable bone mineral substitute material, wherein a composition for a bone mineral substitute material comprising a dry powder to be mixed with an aqueous liquid, the dry powder comprising a first setting reaction component, which is a calcium sulphate hemihydrate;
 a second setting reaction component, which is a calcium phosphate; and   at least one particulate accelerator for the setting reaction of both the first and the second setting reaction components with the aqueous liquid, wherein the at least one accelerator for the reaction of the first setting reaction component with the aqueous liquid is particulate calcium sulphate dihydrate, and the at least one accelerator for the reaction of the second setting reaction component with the aqueous liquid is hardened particulate calcium phosphate cement,   is mixed with the aqueous liquid in a closed mixing and delivery system.   
     
     
         35 . The method of  claim 34 , wherein the mixing is conducted under conditions of subatmospheric pressure. 
     
     
         36 . A method of producing an injectable bone mineral substitute material, wherein a composition for a bone mineral substitute material comprising a dry powder to be mixed with an aqueous liquid, the dry powder comprising
 a first setting reaction component, which is a calcium sulphate hemihydrate;   a second setting reaction component, which is a calcium phosphate;   at least one accelerator for the setting reaction of the first or second setting reaction component, or both the first and the second setting reaction components with the aqueous liquid, wherein the at least one accelerator is chosen from at least one accelerator for the reaction of the first setting reaction component with the aqueous liquid, wherein the accelerator is particulate calcium sulphate dihydrate, and the at least one accelerator for the reaction of the second setting reaction component with the aqueous liquid, wherein the accelerator is hardened particulate calcium phosphate cement; and   a biologically compatible oil to improve the injectability of the composition, is mixed with the aqueous liquid in a closed mixing and delivery system.   
     
     
         37 . The method of  claim 36 , wherein the mixing is conducted under conditions of subatmospheric pressure. 
     
     
         38 . A method of producing an injectable bone mineral substitute material, wherein a composition for a bone mineral substitute material comprising
 a dry powder to be mixed with an aqueous liquid, the dry powder comprising a first setting reaction component, which is a calcium sulphate hemihydrate;   a second setting reaction component, which is a calcium phosphate;   at least one accelerator for the setting reaction of the first or the second setting reaction component, or both the first and the second setting reaction components with the aqueous liquid, wherein the at least one accelerator is chosen from at least one accelerator for the reaction of the first setting reaction component with the aqueous liquid, the accelerator being a particulate calcium sulphate dihydrate, and at least one accelerator for the reaction of the second setting reaction component with the aqueous liquid, the accelerator being a hardened particulate calcium phosphate cement; and   a pH reducing component to improve the injectability of the composition,   is mixed with the aqueous liquid in a closed mixing and delivery system.   
     
     
         39 . The method of  claim 38 , wherein the mixing is conducted under conditions of subatmospheric pressure. 
     
     
         40 . A method of producing a composition for bone mineral substitute material, comprising contacting a composition for a bone mineral substitute material comprising a dry powder to be mixed with an aqueous liquid, the dry powder comprising a first setting reaction component, which is a calcium sulphate hemihydrate;
 a second setting reaction component, which is a calcium phosphate; and   at least one particulate accelerator for the setting reaction of both the first and the second setting reaction components with the aqueous liquid, wherein the at least one accelerator for the reaction of the first setting reaction component with the aqueous liquid is particulate calcium sulphate dihydrate, and the at least one accelerator for the reaction of the second setting reaction component with the aqueous liquid is hardened particulate calcium phosphate cement,   with an aqueous liquid.   
     
     
         41 . The method of  claim 40 , wherein the composition is capable of being hardened in a body fluid in vivo to a bi-phasic cement implant that with time obtains a porous structure for bone ingrowth.