Bone substitute composition

Abstract

An injectable bone mineral substitute material composition with the capability of being hardened in a body fluid in vivo, which comprises at least one calcium phosphate component and at least one calcium sulfate component as a dry mixture mixed with an aqueous liquid, and at least one accelerator, the at least one calcium sulfate component being particulate hardened calcium sulfate, which has a specified particle size that is in order to confer injectablity to the composition. The invention also concerns the bone mineral substitute material produced from the composition as well as methods and uses thereof.

1 .- 45 . (canceled) 
     
     
         46 . A method for fixing a prosthesis comprising:
 a) mixing a dry powder composition comprising a calcium phosphate component and a calcium sulfate component with an aqueous liquid;   b) injecting the resulting composition from step a) into a bone cavity;   c) introducing a prosthesis into the bone cavity; and   d) allowing the injectable composition to harden in vivo.   
     
     
         47 . The method of  claim 46 , wherein the calcium phosphate component is chosen from tetracalcium phosphate (TTCP), monocalcium phosphate monohydrate (MCPM), dicalcium phosphate dihydrate (DCPD), anhydrous dicalcium phosphate (DCPA), dicalcium phosphate (OCP), tricalcium phosphate (TCP), and octocalcium phosphate (OCP). 
     
     
         48 . The method of  claim 46 , wherein the calcium sulfate component is chosen from a hardened particulate calcium sulfate and a calcium sulfate hemihydrate. 
     
     
         49 . The method of  claim 48 , wherein the hardened particulate calcium sulfate is calcium sulfate dihydrate. 
     
     
         50 . The method of  claim 48 , wherein the calcium sulfate hemihydrate is in the α-form. 
     
     
         51 . The method of  claim 46 , wherein the calcium sulfate component is present in an amount up to 60 wt % of the dry powder composition. 
     
     
         52 . The method of  claim 46 , wherein the calcium sulfate component is present in an amount ranging from 10 wt % to 40 wt % of the dry powder composition. 
     
     
         53 . The method of  claim 46 , wherein the calcium sulfate component is calcium sulfate hemihydrate and is present in an amount up to 60 wt % of the dry powder composition. 
     
     
         54 . The method of  claim 46 , wherein the calcium sulfate component further includes an additive. 
     
     
         55 . The method of  claim 46 , wherein the calcium phosphate component is present in an amount ranging from 40 wt % to 98 wt % of the dry powder composition. 
     
     
         56 . The method of  claim 46 , wherein the calcium phosphate component is hydroxyapatite. 
     
     
         57 . The method of  claim 56 , wherein the hydroxyapatite is present in an amount ranging from 40 wt % to 98 wt % of the dry powder composition. 
     
     
         58 . The method of  claim 46 , wherein the aqueous liquid is distilled water. 
     
     
         59 . The method of  claim 46 , wherein the aqueous liquid further comprises an X-ray contrast agent. 
     
     
         60 . The method of  claim 59 , wherein the X-ray contrast agent is iohexyl. 
     
     
         61 . The method of  claim 46 , wherein the dry powder composition further comprises an accelerator. 
     
     
         62 . The method of  claim 54 , wherein the additive is an antibiotic. 
     
     
         63 . The method of  claim 62 , wherein the antibiotic is gentamicin sulfate. 
     
     
         64 . The method of  claim 46 , wherein the method is for prosthetic revision surgery. 
     
     
         65 . The method of  claim 46 , wherein the calcium sulfate component has a particle diameter size of less than 100 μm. 
     
     
         66 . The method of  claim 46 , wherein the calcium sulfate component has a particle diameter size ranging from 1 μm to 50 μm. 
     
     
         67 . The method of  claim 46 , wherein the injectable composition from step a) can be injected through a needle having a diameter of about 1 mm to 2 mm. 
     
     
         68 . The method of  claim 46 , wherein the aqueous liquid is present in an amount ranging from 0.1 ml to 2 ml per gram of the dry powder composition.