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Last Updated: April 20, 2024

Claims for Patent: 6,326,018

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Summary for Patent: 6,326,018

Title:	Flexible sheet of demineralized bone
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. (West Milford, NJ), Sunwoo; Moon Hae (Old Tappan, NJ)
Assignee:	Musculoskeletal Transplant Foundation (Edison, NJ)
Application Number:	09/413,815
Patent Claims:	1. A sterile flexible sheet of allograft bone for application to a bone defect site comprising a high molecular weight cross linked hydrogel selected from a group consisting of hyaluronic acid and chitosan having a molecular weight of at least 500,000 Daltons in a water solution with a concentration of demineralized human bone particles ranging from about 25% to about 50% by weight, the demineralized bone particles ranging in size from about 250 to about 850 microns in size, said concentration being lyophilized to remove the water component of said solution leaving behind a flexible static sheet of bone particles suspended in the dehydrated hydrogel matrix. 2. A flexible sheet of allograft bone as claimed in claim 1 wherein said hydrogel has a molecular weight in excess of one million Daltons. 3. A sterile flexible sheet of demineralized bone as claimed in claim 1 including the addition of a calcium salt to the hydrogel carrier. 4. A sterile flexible sheet of demineralized bone as claimed in claim 3 wherein said calcium salt is calcium chloride. 5. A sterile flexible sheet of demineralized bone as claimed in claim 3 wherein said calcium salt is calcium sulfate. 6. A sterile flexible sheet of demineralized bone as claimed in claim 3 wherein said calcium salt is calcium phosphate. 7. A sterile flexible sheet of demineralized bone as claimed in claim 3 wherein said calcium salt is calcium hydroxyapatite. 8. A sterile flexible sheet of demineralized bone as claimed in claim 1 wherein said sterile flexible sheet includes BMP in excess of the amount naturally occurring in allogeneic bone. 9. A sterile flexible sheet of demineralized bone as claimed in claim 1 wherein said bone powder is cortical allograft bone powder. 10. A sterile flexible sheet of demineralized bone as claimed in claim 1 wherein said bone powder is corticocancellous. 11. A sterile flexible sheet of demineralized bone as claimed in claim 1 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. 12. A sterile flexible sheet of demineralized bone as claimed in claim 1 including vitamins. 13. A sterile flexible sheet of demineralized bone as claimed in claim 1 including enzymes such as collagenase, peptidases and oxidases. 14. A sterile sheet of demineralized bone 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 allograft human bone powder with a particle size ranging from about 100 to about 420 microns mixed in a hydrogel and water based carrier, bone powder content ranging from about 30% to about 33% by weight of the composition and the hydrogel component being hyaluronic acid ranging from about 1.0% to about 3% of the weight of the carrier and having a molecular weight of at least 500,000 Daltons, said mixture being lyophilized to form a flexible static sheet.

Details for Patent 6,326,018

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Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965	⤷ Try a Trial	2018-02-27
>Applicant	>Tradename	>Biologic Ingredient	>Dosage Form	>BLA	>Approval Date	>Patent No.	>Expiredate

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