Osteoinductive ceramic materials

Abstract

The invention relates to an osteoinductive biomaterial, which is based on a ceramic material and which has a total porosity of 20 to 90%, wherein macropores are present having a size ranging from 0.1 to 1.5 mm, and wherein micropores are present having a size ranging from 0.05 to 20 μm. The invention further relates to a process for preparing said osteoinductive biomaterial.

What is claimed is:  
     
         1 . An osteoinductive biomaterial comprising at least one ceramic material having a total porosity of between about 20% to about 90%, with the ceramic material including macropores having a size ranging from about 0.1 mm to about 1.5 mm, and with the ceramic material including micropores having a size ranging from about 0.05 μm to about 20 μm.  
     
     
         2 . The osteoinductive biomaterial according to  claim 1 , wherein the macropores range in size from between about 0.2 mm to about 1.0 mm.  
     
     
         3 . The osteoinductive biomaterial according to  claim 1 , wherein the micropores range in size from between about 0.5 μm to about 10 μm.  
     
     
         4 . The osteoinductive biomaterial according to  claim 1 , wherein the total porosity is between about 40% to about 70%.  
     
     
         5 . The osteoinductive biomaterial according to  claim 1  comprising crystals having a crystal size of between about 0.05 μm to about 20 μm.  
     
     
         6 . The osteoinductive biomaterial according to  claim 1  comprising crystals having a crystal size of between about 0.5 μm to about 10 μm.  
     
     
         7 . The osteoinductive biomaterial according to  claim 1 , wherein the ceramic material includes a material having one or more members selected from the group consisting of calcium phosphate and glass ceramic.  
     
     
         8 . The osteoinductive biomaterial according to  claim 1 , wherein the ceramic material is one or more calcium phosphates selected from the group consisting of octacalcium phosphate, apatites, hydroxyapatite, carbonate apatite, whitlockites, β-tricalcium phosphate and α-tricalcium phosphate.  
     
     
         9 . A process for preparing an osteoinductive biomaterial comprising sintering a ceramic material at a temperature of between about 1000° C. to about 1275° C. to produce a sintered ceramic material, treating the sintered ceramic material with an aqueous solution of at least one acid, and washing the sintered ceramic material to remove the acid.  
     
     
         10 . The process according to  claim 9 , wherein the at least one acid is selected from the group consisting of maleic acid, hydrochloric acid, and phosphoric acid.  
     
     
         11 . The process according to  claim 9 , wherein the aqueous solution has a pH between about 0 to about 4.  
     
     
         12 . The process according to  claim 9 , wherein the sintered ceramic material is washed with one or more of ethanol or water.  
     
     
         13 . A process for preparing an osteoinductive biomaterial comprising preparing a slurry including a powdered ceramic material and an aqueous solution including one or more negative replica forming agents, and sintering the slurry at a temperature of between about 800° C. to about 1200° C.  
     
     
         14 . The process according to  claim 13 , wherein the one or more negative replica forming agents is hydrogen peroxide.  
     
     
         15 . A process according to  claim 9  further including the step of sterilizing the osteoinductive biomaterial.  
     
     
         16 . A process according to  claim 13  further including the step of sterilizing the osteoinductive biomaterial.  
     
     
         17 . An osteoinductive biomaterial prepared by sintering a ceramic material at a temperature of between about 1000° C. to about 1275° C. to produce a sintered ceramic material, treating the sintered ceramic material with an aqueous solution of at least one acid, and washing the sintered ceramic material to remove the acid.  
     
     
         18 . An osteoinductive biomaterial prepared by preparing a slurry including a powdered ceramic material and an aqueous solution including one or more negative replica forming agents, and sintering the slurry at a temperature of between about 800° C. to about 1200° C.  
     
     
         19 . A medical implant comprising the osteoinductive biomaterial of  claim 1 .  
     
     
         20 . A scaffold for tissue engineering a bone equivalent comprising the osteoinductive biomaterial of  claim 1 .  
     
     
         21 . A method of inducing bone formation in a mammal comprising implanting the osteoinductive biomaterial of  claim 1  into a mammal in a manner to induce bone formation on the osteoinductive biomaterial.