Claims for Patent: 5,797,871

Summary for Patent: 5,797,871

Title:	Ultrasonic cleaning of allograft bone
Abstract:	The present invention is directed to a method for cleaning cadaveric donor bone to produce bone grafts suitable for transplantation into a human, as well as the bone grafts produced thereby. The present method involves removing bone marrow potentially containing bacteria, virus or fungi, from the donor bone by sonicating the bone in a solvent containing one or more detergents to produce bone grafts essentially free from bone marrow, as well as bone grafts essentially free from any detectable bacterial, fungal, or viral contamination.
Inventor(s):	Wolfinbarger, Jr.; Lloyd (Norfolk, VA)
Assignee:	LifeNet Research Foundation (Virginia Beach, VA)
Application Number:	08/646,519
Patent Claims:	1. A method for producing a bone graft suitable for transplantation into a human, comprising: sonicating said bone graft with a solvent comprising one or more detergents in an ultrasonic cleaner at a temperature from 37.degree. to 50.degree. C. and for a time period effective to produce a cleaned bone graft essentially free from bone marrow. 2. The method of claim 9, wherein said bone graft is an essentially intact bone graft, further comprising: inducing a pressure mediated flow of said solvent through an opening in a bone shaft of said essentially intact bone graft, wherein said pressure mediated flow is carried out for a period of time effective to produce a cleaned bone graft essentially free from bone marrow, and wherein said step of sonicating and said step of inducing are carried out simultaneously. 3. The method of claim anyone of claims 2 or 23, wherein said flow is mediated at a positive pressure at or above 1 atmosphere, or said flow is mediated at a negative pressure below 1 atmosphere. 4. The method of claim 3, wherein said pressure mediated flow of solvent is conducted and effluent solvent is collected, in an essentially closed system. 5. An essentially intact bone graft produced by the process as claimed in claim 3. 6. The method of claim 1, wherein said temperature is in a range of from about 37.degree. C. to about 44.degree. C. and said time period is for about 30 minutes. 7. The method of claim 6, wherein said ultrasonic cleaner is operated in a range of from 40 to 47 KHZ. 8. A bone graft suitable for transplantation into a human, comprising the cleaned bone graft produced by the process as claimed in any one of claims 1, 6, or 7. 9. The method of claim 1, wherein said bone graft is an essentially intact bone graft or a small cut bone graft. 10. A method for producing a bone graft suitable for transplantation into a human, comprising: sonicating at a temperature from 37.degree. to 50.degree. C. said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft, and wherein said first cleaned bone graft is essentially free from bone marrow. 11. The method of claim 10, further comprising: agitating said first cleaned bone graft with a second solvent comprising one or more members selected from the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft; and agitating said second cleaned bone graft with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft. 12. The method of claim 11, further comprising: agitating said second cleaned bone graft with sterile water prior to sonication with said third solvent. 13. The method of claim 11 or 12 further comprising: agitating said third cleaned bone graft with a fourth solvent comprising one or more alcohols to produce a fourth cleaned bone graft. 14. The method of claim 13, further comprising washing said forth cleaned bone graft with sterile water. 15. The method of claim 14, wherein said washing comprises: soaking, sonicating, lavage or agitation. 16. The method of claim 11, wherein said agitating comprises mild agitation. 17. The method of claim 11, wherein said agitating comprises vigorous agitation. 18. The method of claim 10, further comprising: sonicating said first cleaned bone graft using an ultrasonic cleaning device with a second solvent comprising one or more members selected from the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft; and sonicating said second cleaned bone graft using an ultrasonic cleaning device with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft. 19. The method of claim 18, further comprising: sonicating said second cleaned bone graft with sterile water prior to sonication with said third solvent. 20. The method of anyone of claims 18 or 19, further comprising: sonicating said third cleaned bone graft with a fourth solvent comprising one or more alcohols to produce a fourth cleaned bone graft. 21. The method of claim 20, further comprising: washing said fourth cleaned bone graft with sterile water. 22. A method for producing an essentially intact bone graft suitable for transplantation into a human, comprising: inducing a negative pressure mediated flow of a first solvent, said first solvent comprising one or more detergents, through an opening in a bone shaft of said essentially intact bone graft to produce a cleaned intact bone graft; sonicating said essentially intact bone graft in a container with said first solvent using an ultrasonic cleaner, wherein said inducing and said sonicating are carried out simultaneously for a time effective to produce a cleaned intact bone graft essentially free from bone marrow. 23. A method for producing an essentially intact bone graft suitable for transplantation into a human, comprising: sonicating said bone graft with a solvent comprising one or more detergents in an ultrasonic cleaner at a temperature and for a time period effective to produce a cleaned bone graft essentially free from bone marrow and, inducing a pressure mediated flow of said solvent through an opening in a bone shaft of said essentially intact bone graft wherein said pressure mediated flow is carried out for a period of time effective to produce a cleaned bone graft essentially free from bone marrow, and wherein said step of sonicating and said step of inducing are carried out simultaneously. 24. A method for producing a bone graft suitable for transplantation into a human, comprising: sonicating said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft; sonicating said first cleaned bone graft using an ultrasonic cleaning device with a second solvent comprising one or more members selected form the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft, and sonicating said second cleaned bone graft using an ultrasonic cleaning device with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft, wherein said third cleaned bone graft is essentially free from bone marrow. 25. A method for producing a bone graft suitable for transplantation into a human, comprising: sonicating said bone graft using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned bone graft; agitating said first cleaned bone graft with a second solvent comprising one or more members selected from the group consisting of: an antibiotic, an antimycotic and an antiviral agent, to produce a second cleaned bone graft; and agitating said second cleaned bone graft with a third solvent comprising one or more decontaminating agents to produce a third cleaned bone graft, wherein said third cleaned bone graft is essentially free from bone marrow .

Details for Patent 5,797,871

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2014-08-19