Ceramic composition for filling bone defects

Abstract

The invention is directed toward a sterile formable implant composition for application to a bone defect site comprising bioactive glass particles in an aqueous carrier solution, the bioactive glass particles being added to a viscous carrier at a concentration ranging from about 68% to about 76% (w/w), the carrier comprising a mixture of glycerol and polyethylene glycol ranging from 24% to 32% (w/w) with the ratio of glycerol to polyethylene glycol ranging from about 45:55 to about 65:35.

1 .- 21 . (canceled) 
     
     
         22 . A composition for application to a bone defect site comprising (A) bioactive glass, (B) a carrier and (C) one or more additives,
 wherein said bioactive glass is present in an amount ranging from about 68% to about 76% (w/w) of the composition,   wherein the carrier comprises a mixture of glycerol and polyethylene glycol, and the carrier is present in an amount ranging from about 24% to about 32% (w/w) of the composition; in which the glycerol and polyethylene glycol are present in a ratio of glycerol to polyethylene glycol ranging from about 45:55 to about 65:35, and   wherein the one or more additives comprise bone morphogenic proteins, collagens, hydroxyapatites, amino acids, peptides, vitamins, co-factors for protein synthesis; hormones, endocrine tissues or tissue fragments; synthesizers; enzymes; polymer cell scaffolds with parenchymal cells; angiogenic drugs, polymeric carriers containing one or more drugs; collagen lattices; biocompatible surface active agents, antigenic agents; cytoskeletal agents; cartilage fragments, glucoses, glycosaminoglycans, proteoglycans, carboxymethylcelluloses, red blood cells, white blood cells, platelets, osteoclasts, endothelial cells or combinations thereof.   
     
     
         23 . The composition of  claim 22 , wherein the glycosaminoglycan comprises one or more hyaluronic acids, dermatan sulfates, chondroitin sulfates, heparins, heparin sulfates, or keratan sulfates. 
     
     
         24 . The composition of  claim 22 , wherein the enzyme comprises one or more collagenases, peptidases, or oxidases. 
     
     
         25 . The composition of  claim 22 , wherein the composition is malleable during application of the composition to the bone defect. 
     
     
         26 . The composition of  claim 22 , wherein the composition is a putty. 
     
     
         27 . The composition of  claim 22 , wherein the bioactive glass is present in an amount ranging from about 68% to about 70% (w/w) of the composition. 
     
     
         28 . The composition of  claim 22 , wherein said bioactive glass comprises units ranging in size from 32 microns to 710 microns. 
     
     
         29 . The composition of  claim 22 , wherein said bioactive glass comprises (a) glass particles and (b) glass powder, wherein said glass powder ranges from 32 μm to 90 μm in size. 
     
     
         30 . The composition of  claim 22 , wherein said bioactive glass comprises (a) glass particles wherein said glass particles range from 90 μm to 710 μm in size and (b) glass powder. 
     
     
         31 . The composition of  claim 22 , wherein said bioactive glass comprises glass particles ranging from 90 μm to 710 μm in size and glass powder ranging from 32 μm to 90 μm in size, and wherein said glass particles and said glass powder are present in a ratio of glass particles to glass powder ranging from about 3.5:1 to about 5:1. 
     
     
         32 . The composition of  claim 22 , wherein said bioactive glass comprises glass particles and glass powder, and wherein said glass particles are present in an amount ranging from about 53% to about 62% (w/w) of the composition. 
     
     
         33 . The composition of  claim 22 , wherein said bioactive glass comprises glass particles and glass powder, and wherein said glass powder is present in an amount ranging from about 12% to about 19% (w/w) of the composition. 
     
     
         34 . The composition of  claim 22 , wherein said glycerol and said polyethylene glycol are present in a ratio of glycerol to polyethylene glycol of about 50:50. 
     
     
         35 . The composition of  claim 22 , wherein said polyethylene glycol has a molecular weight ranging from 1000 to 2000 Daltons. 
     
     
         36 . The composition of  claim 22 , wherein said composition has been sterilized by gamma radiation. 
     
     
         37 . The composition of  claim 22 , further comprising one or more growth factor additives, wherein said growth factor additive comprises a transforming growth factor, an insulin growth factor, a platelet derived growth factor, a vascular endothelial growth factor, a fibroblast growth factor, osteopontin, a growth hormone, somatotropin, or combinations thereof. 
     
     
         38 . The composition of  claim 22 , further comprising one or more growth factor additives wherein said growth factor additive comprises a fibroblast growth factor, a variant thereof, or combinations thereof in an amount of 2 to 4 milligrams per 10 cc of carrier. 
     
     
         39 . The composition of  claim 22 , further comprising one or more antiviral additives, antimicrobials, antibiotics, or combinations thereof, wherein said antiviral additive comprises one or more of an antiviral additive that is effective against HIV and hepatitis, and wherein said antimicrobial or antibiotic comprises one or more of erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin, streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin, gentamycin, or combinations thereof 
     
     
         40 . The composition of  claim 22 , further comprising living cells. 
     
     
         41 . The composition of  claim 40 , wherein the living cells comprise chondrocytes, platelets, blood plasma, bone marrow cells, mesenchymal stem cells, pluripotential cells, osteoblasts, fibroblasts, or combinations thereof. 
     
     
         42 . The composition of  claim 40 , wherein the living cells are present in an amount ranging from 10 5  to 10 8  per cc of the carrier. 
     
     
         43 . A composition for application to a bone defect site comprising (A) bioactive glass, (B) a carrier and (C) one or more additives,
 wherein said bioactive glass is present in an amount ranging from about 68% to about 76% (w/w) of the composition, and said bioactive glass comprises glass particles ranging from 90 μm to 710 μm in size,   wherein the carrier comprises a mixture of glycerol and polyethylene glycol, and the carrier is present in an amount ranging from about 24% to about 32% (w/w) of the composition, and wherein said glycerol and said polyethylene glycol are present in a ratio of glycerol to polyethylene glycol ranging from about 45:55 to about 65:35, and   wherein the one or more additives comprise bone morphogenic proteins, collagens, hydroxyapatites, amino acids, peptides, vitamins, co-factors for protein synthesis; hormones, endocrine tissues or tissue fragments; synthesizers; enzymes; polymer cell scaffolds with parenchymal cells; angiogenic drugs, polymeric carriers containing one or more drugs; collagen lattices; biocompatible surface active agents, antigenic agents; cytoskeletal agents; cartilage fragments, glucoses, glycosaminoglycans, proteoglycans, carboxymethylcelluloses, red blood cells, white blood cells, platelets, osteoclasts, endothelial cells or combinations thereof.   
     
     
         44 . The composition of  claim 43 , wherein the glycosaminoglycan comprises one or more hyaluronic acids, dermatan sulfates, chondroitin sulfates, heparins, heparin sulfates, or keratan sulfates. 
     
     
         45 . The composition of  claim 43 , wherein the enzyme comprises one or more collagenases, peptidases, or oxidases. 
     
     
         46 . A composition for application to a bone defect site comprising (A) bioactive glass, (B) a carrier and (C) one or more additives,
 wherein said bioactive glass comprises glass particles ranging from 90 μm to 710 μm in size and glass powder ranging from 32 μm to 90 μm in size, wherein said glass particles and said glass powder are present in a ratio of glass particles to glass powder ranging from about 3.5:1 to about 5:1, and wherein said bioactive glass is present in an amount ranging from about 68% to about 76% (w/w) of the composition,   wherein the carrier comprises a mixture of glycerol and polyethylene glycol, and wherein the carrier is present in an amount ranging from about 24% to about 32% (w/w) of the composition, and wherein said glycerol and said polyethylene glycol are present in a ratio of glycerol to polyethylene glycol ranging from about 45:55 to about 65:35, and   wherein the one or more additives comprise bone morphogenic proteins, collagens, hydroxyapatites, amino acids, peptides, vitamins, co-factors for protein synthesis; hormones, endocrine tissues or tissue fragments; synthesizers; enzymes; polymer cell scaffolds with parenchymal cells; angiogenic drugs, polymeric carriers containing one or more drugs; collagen lattices; biocompatible surface active agents, antigenic agents; cytoskeletal agents; cartilage fragments, glucoses, glycosaminoglycans, proteoglycans, carboxymethylcelluloses, red blood cells, white blood cells, platelets, osteoclasts, endothelial cells or combinations thereof.   
     
     
         47 . The composition of  claim 46 , wherein the glycosaminoglycan comprises one or more hyaluronic acids, dermatan sulfates, chondroitin sulfates, heparins, heparin sulfates, or keratan sulfates. 
     
     
         48 . The composition of  claim 46 , wherein the enzyme comprises one or more collagenases, peptidases, or oxidases.