Anhydrous biocompatible composite materials

Abstract

The invention is directed to biocompatible composite materials for medical applications such as tissue regeneration. In particular, the present invention is directed to biocompatible composite materials that may be used for the treatment of lost bone or bone defects. According to the invention there is provided an anhydrous biocompatible composite material comprising a biodegradable polymeric material and a granular synthetic material, wherein the polymeric material essentially consists of at least one block copolymer that comprises at least one hydrophilic block and at least one hydrophobic block.

1 . An anhydrous biocompatible composite material comprising a biodegradable polymeric material and a granular synthetic material, wherein the polymeric material consists essentially of at least one block copolymer, wherein said at least one block copolymer is a polymer of formula (I)
   X n -B q -A p -B q -X m -[B q -A p -B q ] l    (I)
   
       wherein;
 A and B are independently methylene oxide, ethylene oxide, propylene oxide, butylene oxide, dioxanone or phenyl oxide; 
 X is a polyamide, polyester, polyurethane, polycarbonate or polyester unit; 
 l is 0 or 1; 
 m is 1 to 25; 
 n is 0 to 25; 
 p is 2 to 150; 
 q is 0 to 100; and 
 l+n is more than 0. 
 
     
     
         2 . The anhydrous biocompatible composite material of  claim 1 , wherein l is 0 and n is m. 
     
     
         3 . The anhydrous biocompatible composite material of  claim 1 , wherein l is 1 and n is 0. 
     
     
         4 . The anhydrous biocompatible composite material of  claim 1 , wherein m is 2 to 10, and/or p is 6 to 100, and/or q is 0 to 50. 
     
     
         5 . The anhydrous biocompatible composite material of  claim 1 , wherein the granular synthetic material is osteoconductive. 
     
     
         6 . The anhydrous biocompatible composite material of  claim 1 , wherein the granular synthetic material comprises calcium phosphate. 
     
     
         7 . The anhydrous biocompatible composite material of  claim 1 , wherein the actual ratio (n+m) to (p+q), as determined by  1 H NMR, is less than 0.36. 
     
     
         8 . The anhydrous biocompatible composite material of  claim 1 , wherein m is n; l and q are 0. 
     
     
         9 . The anhydrous biocompatible composite material of  claim 1 , that is an injectable, malleable and/or kneadable no-sticky putty that retains its shape at a typical temperature of 15 to 40° C. 
     
     
         10 . The anhydrous biocompatible composite material of  claim 9 , that has been sterilized by γ-rays or electron beams. 
     
     
         11 . A method to treat connective tissue and/or bone loss or defect which method comprises administering to a subject in need of such treatment the anhydrous biocompatible composite material of  claim 1 . 
     
     
         12 . A method to sterilize a biodegradable polymeric material consisting essentially of one or more block copolymer comprising at least one hydrophilic block and at least one hydrophobic block, which method comprises irradiating the biodegradable polymeric material by γ-rays or electron beams. 
     
     
         13 . A method to treat bone loss or defect, which method comprises shaping the anhydrous biocompatible composite material of  claim 1  into a desired shape and placing said shaped material at the site of bone loss or defect. 
     
     
         14 . The anhydrous biocompatible composite material of  claim 1 , wherein A and B are ethylene oxide or propylene oxide. 
     
     
         15 . The anhydrous biocompatible composite material of  claim 1 , wherein X is a polyester unit. 
     
     
         16 . The anhydrous biocompatible composite material of  claim 1 , wherein X is a hydroxybutyrate, lactic acid, glycolide, γ-butyrolactone, δ-valerolactone or ε-caprolactone. 
     
     
         17 . The anhydrous biocompatible composite material of  claim 16 , wherein X is lactic acid. 
     
     
         18 . The anhydrous biocompatible composite material of  claim 4 , wherein m is 3 to 7. 
     
     
         19 . The anhydrous biocompatible composite material of  claim 4 , wherein p is 40 to 50. 
     
     
         20 . The anhydrous biocompatible composite material of  claim 4 , wherein q is 0 to 19. 
     
     
         21 . The anhydrous biocompatible composite material of  claim 5 , wherein the granular synthetic material is osteoinductive. 
     
     
         22 . The anhydrous biocompatible composite material of  claim 7 , wherein the ratio (n+m) to (p+q), as determined by  1 H NMR, is less than 0.30. 
     
     
         23 . The anhydrous biocompatible composite material of  claim 22 , wherein the ratio (n+m) to (p+q), as determined by  1 H NMR, is between 0.01 and 0.25. 
     
     
         24 . The anhydrous biocompatible composite material of  claim 23 , wherein the ratio (n+m) to (p+q), as determined by  1 H NMR, is between 0.05 and 0.15. 
     
     
         25 . The anhydrous biocompatible composite material of  claim 7 , wherein the ratio (n+m) to (p+q), as determined by  1 H NMR, is less than 0.10. 
     
     
         26 . A method to engineer tissue to correct a connective tissue and/or bone defect which method comprises providing anhydrous biocompatible composite material of  claim 1  to the defect.