Claims for Patent: 6,024,735

Summary for Patent: 6,024,735

Title:	Process and composition for cleaning soft tissue grafts optionally attached to bone and soft tissue and bone grafts produced thereby
Abstract:	The invention relates to compositions effective for the cleansing of mammalian soft tissue optionally attached to bones, and particularly the removal of blood deposits and bone marrow therefrom. The compsotions are composed of an aqueous solution containing as its essential ingredients a detergent having a functionality of the nature of a polyoxyethylene-23-lauryl either, a detergent having a functionality of the nature of exyethylated alkylphenol, and water, where the compositions are free from any membrane stabilizers. The present invention is also directed to a method and composition for cleaning cadaveric soft tissue optionally attached to bone to produce soft tissue grafts optionally attached to bone suitable for transplantation into a human. The present method involves removing bone marrow elements, blood deposits and any bacteria, virus or fungi contamination, from the donor bone and/or associated soft tissues.
Inventor(s):	Wolfinbarger, Jr.; Lloyd (Norfolk, VA)
Assignee:	LifeNet Research Foundation (Virginia Beach, VA)
Application Number:	08/895,203
Patent Claims:	1. A method for producing a soft tissue graft suitable for transplantation into a human, comprising: sonicating said soft tissue with a solvent comprising one or more detergents in an ultrasonic cleaner at a temperature and for a time period effective to produce cleaned soft tissue essentially free from blood deposits. 2. A soft tissue graft suitable for transplantation into a human, comprising the cleaned soft tissue produced by the process as claimed in claim 1. 3. The soft tissue graft of claim 2, wherein said associated soft tissue comprises one or more members selected from the group consisting of ligament tissue, tendon tissue, periosteum, cartilage, menisci and fascia lata tissue. 4. A soft tissue graft produced by the process as claimed in claim 1, wherein said graft is essentially free from bacterial, viral and fungal contamination. 5. A method for producing a soft tissue graft including attached to an essentially intact bone 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 and associated soft tissue to produce a cleaned intact bone graft including associated soft tissue; sonicating said essentially intact bone graft and associated soft tissue 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 and associated soft tissues essentially free from bone marrow. 6. A soft tissue graft produced by the process as claimed in claim 5, wherein said graft is essentially free from bacterial, viral and fungal contamination. 7. A method for producing a soft tissue graft optionally attached to bone suitable for transplantation into a human, comprising: sonicating said soft tissue using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned soft tissue graft, and wherein said first cleaned soft tissue is essentially free from blood deposits. 8. The method of claim 7, further comprising: sonicating said first cleaned soft tissue 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 soft tissue graft; and sonicating said second cleaned soft tissue graft using an ultrasonic cleaning device with a third solvent comprising one or more decontaminating agents to produce a third cleaned soft tissue graft. 9. The method of claim 8, further comprising: sonicating said second cleaned soft tissue graft with sterile water prior to sonication with said third solvent. 10. The method of any one of claims 8 or 9, further comprising: sonicating said third cleaned soft tissue graft with a fourth solvent comprising one or more alcohols to produce a fourth cleaned soft tissue graft. 11. The method of claim 10, further comprising: washing said fourth cleaned soft tissue graft and with sterile water. 12. The method of claim 7, further comprising: agitating said first cleaned soft tissue 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 soft tissue graft; and agitating said second cleaned soft tissue graft with a third solvent comprising one or more decontaminating agents to produce a third cleaned soft tissue graft. 13. The method of claim 12, further comprising: agitating said second cleaned soft tissue graft with sterile water prior to sonication with said third solvent. 14. The method of claims 12 or 13 further comprising: agitating said third cleaned soft tissue graft with a fourth solvent comprising one or more alcohols to produce a fourth cleaned soft tissue graft. 15. The method of claim 14, further comprising washing said fourth cleaned soft tissue graft with sterile water. 16. The method of claim 15, wherein said washing comprises one or more of soaking, sonicating, lavage and agitation. 17. The method of claim 16, wherein said washing is conducted in a negative pressure environment. 18. The method of any one of claims 1, or 7, wherein said soft tissue graft comprises one or more members selected from the group consisting of ligament tissue, tendon tissue, periosteum, cartilage, menisci and fascia lata tissue. 19. A soft tissue graft produced by the process as claimed in claim 7, wherein said graft is essentially free from bacterial, viral and fungal contamination. 20. A method for producing a soft tissue graft suitable for transplantation into a human, comprising: sonicating said soft tissue in one or more bone cleaning compositions to produce a cleaned graft; incubating said cleaned graft in one or more decontaminating agents to produce a decontaminated graft; and incubating said decontaminated graft in water to produce soft tissue graft suitable for transplantation into a human. 21. A soft tissue graft produced by the process as claimed in claim 20, wherein said graft is essentially free from bacterial, viral and fungal contamination. 22. The method of claim 20, wherein said incubating comprises one or more or soaking, sonicating, lavage and agitation. 23. The method of claim 22, wherein said washing is conducted in a negative pressure environment. 24. The method of any one of claims 20 or 22, wherein said bone cleaning composition comprises: i) a detergent having a functionality of the nature of a polyoxyethylene-4-lauryl ether ii) a detergent having a functionality of the nature of oxyethytlated alkylphenol, and iii) water, wherein said detergent having a functionality of the nature of a lauryl ether and said detergent having a functionality of the nature of oxyethylated alkylphenol are present in a weight percent ration of about 1:2, and wherein said composition does not contain a membrane stabilizer. 25. A soft tissue graft produced by the process as claimed in claim 24, wherein said graft is essentially free from bacterial, viral and fungal contamination. 26. A method for producing a soft tissue graft suitable for transplantation into a human, comprising: pre-cleaning said graft with water to produce a pre-cleaned graft; agitating said pre-cleaned graft in water optionally including one or more bone cleaning compositions to produced an agitated graft; sonicating said agitated graft in one or more bone cleaning compositions to produce a cleaned graft; incubating said cleaned graft in one or more decontaminating agents to produce a decontaminated graft; wherein said decontaminated graft is suitable for transplantation into a human. 27. A method for producing a soft tissue graft optionally attached to bone suitable for transplantation into a human, comprising: sonicating said soft tissue using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned soft tissue graft, said first cleaned soft tissue graft us essentially free from blood deposits; sonicating said first cleaned soft tissue 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 soft tissue graft; and sonicating said second cleaned soft tissue graft using an ultrasonic cleaning device with a third solvent comprising one or more decontaminating agents to produce a third cleaned soft tissue graft. 28. A method for producing a soft tissue graft optionally attached to bone suitable for transplantation into a human, comprising: sonicating said soft tissue using an ultrasonic cleaning device with a first solvent comprising one or more detergents to produce a first cleaned soft tissue graft, said first cleaned soft tissue graft us essentially free from blood deposits; agitating said first cleaned soft tissue 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 soft tissue graft; and agitating said second cleaned soft tissue graft with a third solvent comprising one or more decontaminating agents to produce a third cleaned soft tissue graft.

Details for Patent 6,024,735

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		2015-02-27