Malleable paste for filling bone defects

Abstract

The invention is directed toward a malleable bone putty and a flowable gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder. The bone powder has a particle size ranging from about 100 to about 850 microns and is mixed in a high molecular weight hydrogel carrier, the hydrogel component of the carrier ranging from about 0.3 to 3.0% of the composition and having a molecular weight of about at least 10,000 Daltons. The composition contains about 25% to about 40% bone powder and can be additionally provided with BMP's and a sodium phosphate buffer.

1. A sterile malleable bone composition for application to a bone defect site to promote new bone growth at the site comprising a mixture of demineralized osteogenic  osteoinductive bone powder with a particle size ranging from about 100 to about 850 microns in a carrier, the bone powder ranging from about 25 to about 35% of the weight of the composition, the carrier is selected from the group consisting of sodium hyaluronate, chitosan and  consisting of N,O-carboxymethylchitosan in water solution having a high molecular weight ranging from five hundred thousand to three million Daltons and ranging from about  1.0% to about  3.0% by weight of the carrier solution. 
     
     
       2. A sterile malleable bone composition as claimed in  claim 1  wherein said mixture includes bone morphogenic proteins in excess of the amount naturally occurring in allergenic  allogenic bone. 
     
     
       3. A sterile malleable bone composition as claimed in  claim 1  including the addition of a calcium salt to the carrier. 
     
     
       4. A sterile malleable bone composition as claimed in  claim 1  wherein the balance of the carrier formulation contains a sodium phosphate buffer and having a pH of about 7.2. 
     
     
       5. A sterile malleable bone composition as claimed in  claim 1  wherein said bone powder is cortical allograft bone powder. 
     
     
       6. A sterile malleable bone composition as claimed in  claim 1  wherein said bone powder is corticocancellous allograft bone powder. 
     
     
       7. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing mixture of demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a hyaluronic acid water carrier, the hyaluronic acid component ranging from above 1.0% to about 3% of the carrier solution and having a molecular weight of at least 10 6  Daltons and a viscosity ranging from 6,000 to about 275,000 cps, the bone content of the carrier ranging in weight from about 25% to about 35% total weight of the composition. 
     
     
       8. A malleable bone putty composition as claimed in  claim 7  including the addition of a calcium salt to the hyaluronic acid carrier. 
     
     
       9. A malleable bone putty composition as claimed in  claim 8  wherein said calcium salt is calcium chloride. 
     
     
       10. A malleable bone putty composition as claimed in  claim 8  wherein said calcium salt is calcium sulfate. 
     
     
       11. A malleable bone putty composition as claimed in  claim 8  wherein said calcium salt is calcium phosphate. 
     
     
       12. A malleable bone putty composition as claimed in  claim 8  wherein said calcium salt is calcium hydroxyapatite. 
     
     
       13. A malleable bone putty composition as claimed in  claim 7  wherein said carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation comprising saline water. 
     
     
       14. A malleable bone putty composition as claimed in  claim 7  wherein said carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation comprising sterile water. 
     
     
       15. A malleable bone putty composition as claimed in  claim 7  wherein said hydrogel carrier has a 2-3% hyaluronic acid concentration with the balance of the carrier formulation contains a sodium phosphate buffer with a pH of about 7.2, said buffer attracting calcium and concentrating same at the bone defect site. 
     
     
       16. A malleable bone putty composition as claimed in  claim 7  wherein said carrier includes BMP in excess of the amount naturally occurring in allergenic bone. 
     
     
       17. A malleable bone putty composition as claimed in  claim 7  wherein said bone powder is cortical allograft bone powder. 
     
     
       18. A malleable bone putty composition as claimed in  claim 7  wherein said bone powder is corticocancellous. 
     
     
       19. A malleable bone putty composition as claimed in  claim 7  including antimicrobial and/or antibiotics such as erythromycin, bacitracin, neomycin, penicillin, polymyxin B, tetracycline, viomycin, chloromycetin and streptomycin, cefazolin, ampicillin, azactam, tobramycin, clindamycin and gentamycin. 
     
     
       20. A malleable bone putty composition as claimed in  claim 7  including vitamins. 
     
     
       21. A malleable bone putty composition as claimed in  claim 7  including enzymes such as collagenase, peptidases and oxidases. 
     
     
       22. A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 420 microns in a high molecular weight sodium hyaluronate and water carrier, the bone content of the composition ranging from about 30% to about 35% by weight and the high molecular weight sodium hyaluronate component ranges from about 2% to about 3% of the carrier and has a molecular weight greater than one million Daltons. 
     
     
       23. A sterile malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing compound of demineralized lyophilized allograft bone powder with a particle size, ranging from about 100 to about 420 microns in a N,O-carboxymethylchitosan water carrier solution, the N,O-carboxymethylchitosan component ranging from about  1.0% to about  3% of the carrier weight and having a molecular weight ranging from 2.0×10 6 −3.0×10 6  Daltons. 
     
     
       24. A malleable bone putty composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing demineralized lyophilized allograft bone powder with a particle size ranging from about 100 to about 850 microns in a high molecular weight chitosan water carrier solution with the bone content of the putty composition ranging from about 30% to about 35% and the chitosan component comprising about 3% of the carrier solution with the chitosan having a molecular weight ranging from about 1.0×10 3  to 3.0×10 5  Daltons. 
     
     
       25. A malleable bone putty composition as claimed in  claim 24  wherein the carrier formulation includes a sodium phosphate buffer of about pH 7.2. 
     
     
       26. A malleable bone putty composition as claimed in  claim 24  wherein said carrier solution includes saline water. 
     
     
       27. A malleable bone putty composition as claimed in  claim 24  wherein said carrier solution includes sterile water. 
     
     
       28. A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site which comprises a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 850 microns in a high molecular weight hyaluronic acid in water carrier with the hyaluronic acid component comprising about 1% of the carrier and having a molecular weight over 1.0×10 6  Daltons, the bone powder content of the composition ranging from about 25% to about 30%. 
     
     
       29. A malleable bone gel composition for application to a bone defect site to promote new bone growth at the site comprising a new bone growth inducing amount of demineralized lyophilized allograft bone powder with a particle size ranging from about 250 to about 420 microns mixed in a high molecular weight hyaluronic acid water solution carrier with the hyaluronic acid component being present in the amount of about 1% of the carrier and having a viscosity of about 1,800 to 13,000 cps, the bone powder amount content of the composition ranging from about 25% to about 30% by weight.