Bone-regeneration material

Abstract

The invention relates to a process for producing a bone-regeneration material. According to the method, a bio-compatible, open-pored body is exposed to a vacuum and osteoinductive and/or osteogenic substances are absorbed into the pores of the body, for example by means of a vacuum generated therein. It is thus possible to produce a bone-regeneration material, which contains osteoinductive and/or osteogenic substances in the pores of the bio-compatible body, said substances acting as a network structure for new somatic cells that are to grow into the porous body.

1 . A process for the production of a bone regeneration material which contains at least one of: an osteoinductive substance and an osteogenic substance, the process comprising:
 a) providing a biocompatible, open-pore body;   b) exposing the pores of the biocompatible, open-pore body to a vacuum; and   c) drawing the at least one substance into the pores.   
     
     
         2 . The process according to  claim 1 , wherein the osteogenic substance is present in the form of somatic cells in flowable form, and the somatic cells are chosen from the group consisting of:
 a) autologous bone marrow,   b) separated, concentrated cells from autologous bone marrow,   c) cultivated autologous stem cells,   d) differentiated autologous stem cells, and   e) mesenchymal cells.   
     
     
         3 . The process according to  claim 1 , wherein the osteoinductive substance is contained in a body-compatible liquid. 
     
     
         4 . The process according to  claim 1 , wherein the osteogenic substance is suspended in a body-compatible liquid. 
     
     
         5 . The process according to  claim 1 , wherein the osteogenic substance is present in the form of somatic cells in flowable form, and the somatic cells are chosen from the group consisting of:
 a) blood,   b) blood components,   c) bone marrow, and   d) bone cells.   
     
     
         6 . The process according to  claim 1 , wherein the osteogenic substance is present in the form of somatic cells and the somatic cells are of an autologous nature. 
     
     
         7 . The process according to  claim 1 , wherein the osteoinductive substance is chosen from the group consisting of:
 a) synthetic growth factors,   b) recombinant growth factors,   c) β growth factor (TGF-β),   d) FGF-2 (fibroblast growth factor),   e) natural or synthetic peptides,   f) platelet-derived growth factor (PDGF),   g) insulin-like growth factor (IGF),   h) fibrin as end product of blood coagulation, and   i) synthetic fibrin.   
     
     
         8 . The process according to  claim 1 , wherein it is performed in a syringe with a hollow cylinder and a piston, and at least one of the osteoinductive and osteogenic substances are in flowable form and are drawn into the syringe and drawn through the pores of the body housed in the hollow cylinder. 
     
     
         9 . An apparatus for carrying out the process according to  claim 1 , comprising:
 a syringe with a hollow cylinder and a piston, and a biocompatible, open-pore body is housed in the hollow cylinder, said body obstructing a portion of the hollow cylinder so that at least one of the osteoinductive and osteogenic substances flows through the pores of the body when it is drawn by the syringe.   
     
     
         10 . The apparatus according to  claim 9 , wherein the syringe has a head part, which is fastenable on the front end of the hollow cylinder, with a membrane so that at least one of the osteoinductive substance and osteogenic substance is drawn by the syringe, after sealing of the membrane and withdrawal of the piston, and flows through the pores of the body by means of a vacuum. 
     
     
         11 . Bone regeneration material produced according to the process according to  claim 1 . 
     
     
         12 . Bone regeneration material, comprising:
 a biocompatible, open-pore body, wherein at least a part of the pores of the body is filled with at least one of: somatic cells and osteoinductive substances that are not blood based.   
     
     
         13 . The bone regeneration material according to  claim 12 , wherein the body consists at least partially of a bioresorbing material. 
     
     
         14 . The bone regeneration material of  claim 13 , wherein the bioresorbing material comprises hydroxylapatite. 
     
     
         15 . The bone regeneration material of  claim 13 , wherein the bioresorbing material comprises tricalcium phosphate. 
     
     
         16 . The bone regeneration material according to  claim 12 , wherein the porosity of the body is at least 25%. 
     
     
         17 . The bone regeneration material according to  claim 12 , wherein the porosity of the body is at least 35%. 
     
     
         18 . The bone regeneration material according to  claim 12 , wherein at least 50% of the pores have a diameter in the range of 200 to 500 microns. 
     
     
         19 . The bone regeneration material according to  claim 12 , wherein the connection between the individual pores have a diameter in the range of 10 to 300 microns, preferably from 200 to 400 microns. 
     
     
         20 . The bone regeneration material according to  claim 12 , wherein the connection between the individual pores have a diameter in the range of 200 to 400 microns.