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Last Updated: December 15, 2019

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Claims for Patent: RE39587

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Summary for Patent: RE39587
Title: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.
Inventor(s): Gertzman; Arthur A. (Flemington, NJ), Sunwoo; Moon Hae (Old Tappan, NJ)
Assignee: Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:10/843,658
Patent Claims: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.]. .Iadd.osteoinductive .Iaddend.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.]. .Iadd.consisting of .Iaddend.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 .Iadd.sterile .Iaddend.malleable bone composition as claimed in claim 1 wherein said mixture includes bone morphogenic proteins in excess of the amount naturally occurring in .[.allergenic.]. .Iadd.allogenic .Iaddend.bone.

3. A .Iadd.sterile .Iaddend.malleable bone composition as claimed in claim 1 including the addition of a calcium salt to the carrier.

4. A .Iadd.sterile .Iaddend.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 .Iadd.sterile .Iaddend.malleable bone composition as claimed in claim 1 wherein said bone powder is cortical allograft bone powder.

6. A .Iadd.sterile .Iaddend.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.sup.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.times.10.sup.6-3.0.times.10.sup.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.times.10.sup.3 to 3.0.times.10.sup.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.times.10.sup.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..].

Details for Patent RE39587

Applicant Tradename Biologic Ingredient Dosage Form BLA Number Approval Date Patent No. Assignee Estimated Patent Expiration Status Orphan Source
Smith And Nephew SANTYL collagenase OINTMENT;TOPICAL 101995 001 1965-06-04   Start Trial Musculoskeletal Transplant Foundation (Edison, NJ) 2039-02-26 RX search
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Number >Approval Date >Patent No. >Assignee >Estimated Patent Expiration >Status >Orphan >Source

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