Claims for Patent: 5,120,656

Summary for Patent: 5,120,656

Title:	Process for debriding bone
Abstract:	Bone is enzymatically debrided prior to undergoing further processing which renders the bone suitable for osteoprosthetic use.
Inventor(s):	O\'Leary; Robert K. (Spring Lake, NJ), Prewett; Annamarie B. (Fairhaven, NJ)
Assignee:	Osteotech, Inc. (Shrewsbury, NJ)
Application Number:	07/560,661
Patent Claims:	1. A process for the debridement of harvested bone having its periosteum intact which comprises contacting, the periosteum with a solution of at least one collagen-digesting enzyme under enzyme activity-promoting conditions for a period of time sufficient to loosen the periosteum from the underlying bone surface and thereafter removing the enzymatically loosened periosteum from the bone. 2. The process of claim 1 wherein the collagen-digesting enzyme is selected from the group consisting of collagenase, stromelysin and mixtures thereof. 3. The process of claim 1 wherein the temperature of contacting ranges from about 20.degree. C. to about 70.degree. C. 4. The process of claim 1 wherein the temperature of contacting ranges from about 25.degree. to about 55.degree. C. 5. The process of claim 1 wherein the pH ranges from about 3 to 9. 6. The process of claim 1 wherein the contact time of the periosteum with the enzyme solution is at least about 30 minutes. 7. The process of claim 1 wherein the enzyme solution is a sterile physiological saline solution. 8. The process of claim 1 wherein the enzyme solution contains a permeation enhancer. 9. The process of claim 8 wherein the permeation enhancer is a surface active agent. 10. The process of claim 1 wherein the enzyme solution contains at least one member of the group consisting of antibiotic and disinfectant. 11. The process of claim 10 wherein the disinfectant is ethanol. 12. The process of claim 1 wherein the enzyme solution contains a permeation enhancer and at least one member of the group consisting of antibiotic and disinfectant. 13. The process of claim 1 wherein the enzyme solution contains an enzyme permeation enhancing amount of at least one enzyme permeation enhancing surface active agent and a disinfecting amount of ethanol. 14. The process of claim 1 wherein the enzymatically loosened periosteum is removed from the bone by the impact of a high velocity fluid stream directed against the periosteum. 15. The process of claim 14 wherein the high velocity fluid stream is water or physiological saline. 16. The process of claim 1 wherein removal of the enzymatically loosened periosteum from the bone is accompanied by exposure of the bone to sterilizing ultraviolet radiation. 17. The process of claim 15 wherein removal of the enzymatically loosened periosteum from the bone is accompanied by exposure of the bone to sterilizing ultraviolet radiation directed against the surface of the periosteum upon which the high velocity fluid stream impinges. 18. The process of claim 1 wherein the periosteum-containing bone is contacted with a solution of proteolytic enzyme before, during or following contact of the periosteum with the solution of collagen-digesting enzyme. 19. The process of claim 18 wherein the proteolytic enzyme is present in the solution of collagen-digesting enzyme. 20. The process of claim 18 wherein the collagen-digesting enzyme is collagenase. 21. The process of claim 19 wherein the collagen-digesting enzyme is collagenase.

Details for Patent 5,120,656

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Smith & Nephew, Inc.	SANTYL	collagenase	Ointment	101995	06/04/1965		2009-08-18