Claims for Patent: 6,837,907

Summary for Patent: 6,837,907

Title:	Method for debriding bone, and bone debrided thereby
Abstract:	The invention is directed to a method of debriding bone including incubating the bone and associated soft tissue, with one or more debriding solutions where the debriding solution may include one or more alkaline solutions. Incubation is optionally carried out with one or more debriding agents including inert dry granular or particulate material including for example beads, and the granular phase of an alkaline agent, including for example granular sodium hydroxide. The incubating may be carried out with agitation. In another embodiment, the medullary canal of the bone is subjected to a positive pressure stream of debriding solution under conditions sufficient to loosen the associated soft tissue from the bone at the interface of the soft tissue and bone. In a further embodiment, the debriding solution is provided as a gel.
Inventor(s):	Wolfinbarger, Jr.; Lloyd (Virginia Beach, VA), O\'Leary; Robert K. (Deltaville, VA), Ford; Louis (Virginia Beach, VA), Jones; Alyce Linhurst (Virginia Beach, VA)
Assignee:	LifeNet (Virginia Beach, VA)
Application Number:	10/108,804
Patent Claims:	1. A process for debriding bone including soft tissue, comprising: contacting said bone with one or more debriding solutions under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone; and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding solutions are free from proteolytic and collagen-digesting enzymes. 2. The process of claim 1, said debriding solution comprising one or more alkaline solutions. 3. The process of claim 2, said alkaline solution comprising one or more alkaline members selected from the group consisting of: sodium hydroxide, potassium hydroxide, ammonium hydroxide, lithium hydroxide, trisodium phosphate, tripotassium phosphate and triethanolamine. 4. The process of claim 1, said contacting, comprising: contacting said bone with one or more gelled debriding solutions, said gelled debriding solution comprising one or more alkaline solutions, under conditions sufficient to loosen said soft tissue from said bone. 5. The process of claim 3, wherein said alkaline solution is formed by first adding said one or more alkaline members to said bone, where said one or more alkaline members is dry, to form a dry mixture; adding water to said dry mixture, said water in an amount sufficient to form an alkaline solution at a concentration of from 5.0 to 25.0 M over an incubation period, to form an alkaline mixture; incubating said alkaline mixture for an incubation time of from 2 minutes to 20 minutes to form an incubated mixture; further adding water to said incubated mixture in an amount sufficient to decrease concentration of said incubated mixture to a concentration of from 0.1 to 5.0 M to form a dilute alkaline solution, and second incubating said dilute alkaline solution with said bone for a time period sufficient to loosen said soft tissue. 6. The process of claim 1, said bone comprising a medullary canal, and said contacting, comprising: subjecting said medullary canal of said bone to a positive pressure stream of said debriding solution under conditions sufficient to loosen said soft tissue from an external surface of said bone. 7. The process of claim 6, said debriding solution comprising sterile isotonic saline. 8. The process of claim 6, said debriding solution comprising sterile water. 9. The process of claim 7, said positive pressure stream is at a pressure of from 100 kPa to 1000 kPa. 10. The process of claim 8, said subjecting is carried out for a period of time of from 10 minutes to 60 minutes. 11. The process of claim 1, said contacting comprising contacting for a period of time of from 30 minutes to 18 hours. 12. The process of claim 1, said contacting comprising contacting at a temperature of from 5.degree. C. to 65.degree. C. 13. A process for debriding bone including soft tissue comprising contacting said bone with one or more debriding solutions under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding solution comprises one or more alkaline solutions of concentration from 0.1 N to 1.0 N, and wherein said alkaline solutions comprise one or more alkaline members selected from the group consisting of: sodium hydroxide, potassium hydroxide, ammonium hydroxide, lithium hydroxide, trisodium phosphate, tripotassium phosphate and triethanolamine. 14. The process of claim 13, wherein said debriding solution comprises one or more alkaline solutions of concentration from 0.1 M to 25.0 M. 15. The process of claim 13, wherein said debriding solution comprises one or more alkaline solutions of concentration from 0.5 M to 20.0 M. 16. A process for debriding bone including soft tissue comprising contacting said bone with one or more debriding solutions under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said removing step comprises injecting air between said soft tissue and said bone and subjecting said bone and said soft tissue to a flow of aqueous removal solution. 17. The process of claim 1, said debriding solution further comprising one or more permeation enhancers. 18. The process of claim 17, said permeation enhancer comprising a surface-active agent. 19. The process of claim 1, said debriding solution further comprising one or more inactivating agents. 20. The process of claim 19, said inactivating agent is an alcohol. 21. The process of claim 1, said removing comprising: mechanically removing said soft tissue from said bone using mechanical means. 22. The process of claim 16, wherein said removing step comprises mechanically removing said soft tissue from said bone using a scraper. 23. A process for debriding bone including soft tissue comprising contacting said bone including soft tissue with one or more debriding agents under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding agents comprise a granular alkaline agent. 24. The process of claim 6, further comprising after said step of subjecting, mechanically removing said soft tissue from said bone using mechanical means. 25. The process of claim 24, said mechanical means comprising a pot scrubber. 26. The process of any one of claim 1, 6, 21, or 16, wherein any one or more of said steps of removing, mechanically removing, injecting, and subjecting, is performed simultaneously or sequentially. 27. The process of claim 16, said aqueous removal solution comprises sterile endotoxin-free deionized/distilled water. 28. The process of claim 21, said mechanically removing, comprising: scraping said first processed bone under a flow of aqueous removal solution. 29. The process of claim 1, said one or more debriding solutions comprise a gelled solution. 30. The process of claim 29, said gelled solution comprising one or more members selected from the group consisting of a polymer and a thixotropic agent. 31. The process of claim 30, said polymer comprising one or more polymers selected from the group consisting of cellulose, methyl cellulose and carboxy methyl cellulose. 32. A process for debriding bone including soft tissue, comprising: contacting said bone including soft tissue with one or more debriding agents under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone; and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding agents are free from proteolytic and collagen-digesting enzymes. 33. A process for debriding bone including soft tissue, comprising: contacting said bone including soft tissue with one or more debriding agents and one or more debriding solutions, under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone; and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding agents and debriding solutions are free from proteolytic and collagen-digesting enzymes. 34. The process of any one of claim 1, 6, 32 or 33, said bone comprising one or more members selected from the group consisting of allogenic bone, autogenic bone and xenogenic bone. 35. The process of claim 34, said bone comprising allogenic bone. 36. The process of claim 35, said allogenic bone is human cadaveric bone. 37. The process of claim 36, said bone is frozen, thawed, or partially thawed. 38. A process for debriding bone including soft tissue comprising contacting in a closed container said bone including tissue with one or more debriding agents under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone. 39. The process of claim 23 or 38 said debriding agent further comprises inert beads. 40. The process of claim 39, said beads comprising one or more materials selected from the group consisting of an inorganic material and an anorganic material. 41. The process of claim 40, said inorganic material comprises one or more materials selected from the group consisting of glass, ceramic, amorphous, metal, plastic, and crystalline. 42. The process of claim 23 or 38, said granular alkaline agent comprising dry sodium hydroxide. 43. A process for debriding bone including soft tissue comprising contacting in a closed container said bone including soft tissue with one or more debriding agents and one or more debriding solutions, under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone. 44. The process of any one of claim 43, 38, or 23 said closed container comprising a rollable sealable bottle. 45. The process of claim 44, said rollable sealable bottle comprising one or more materials selected from the group consisting of glass and plastic. 46. The process of claim 44, said rollable sealable bottle comprises baffles provided on an interior surface thereof. 47. The process of claim 39, said beads comprise one or more beads of a size of from 0.01 mm to 100 mm in diameter. 48. The process of claim 47, said beads comprise one or more beads of a size of from 0.1 mm to 10 mm in diameter. 49. A process for debriding bone including soft tissue comprising contacting said bone including soft tissue with one or more debriding agents and one or more debriding solutions, under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said debriding agents comprise a granular alkaline agent. 50. A process for debriding bone including soft tissue comprising contacting in a closed container said bone with one or more debriding solutions under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone produce a debrided bone. 51. The process of any one of claim 1, 6, 32, or 33, said contacting is carried out from 30 minutes to 18 hours. 52. A process for debriding bone including soft tissue comprising contacting said bone including soft tissue with one or more debriding agents under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said contacting comprises agitating said bone with said one or more debriding agents, and wherein said agitating comprises rolling. 53. A process for debriding bone including soft tissue comprising contacting said bone including soft tissue with one or more debriding agents and one or more debriding solutions, under conditions sufficient to loosen said soft tissue from said bone to produce a first processed bone, and removing said soft tissue from said first processed bone to produce a debrided bone, wherein said contacting comprises agitating said bone with said one or more debriding agents, and wherein said agitating comprises rolling. 54. The process of claim 52 or 53 said rolling is performed at a rate of from 10 to 100 revolutions per minute. 55. The process of claim 7, said sterile isotonic saline exits said bone at an interface of said bone and said soft tissue, where said soft tissue is loosened from said bone to produce a first debrided bone; and removing loosened soft tissue from said first debrided bone to produce debrided bone. 56. The process of any one of claim 1, 6, 32, or 33, further comprising treating said debrided bone with a cleansing solution to produce a cleansed bone. 57. The process of claim 56, said cleansing solution is at a pH of from 4 to 7. 58. The process of claim 57, said cleansing solution comprising N-lauroylsarcosinate. 59. The process of claim 58, said N-lauroylsarcosinate is at a concentration sufficient to inactivate one or more of bacterial, viral, microbial, fungal and prion contamination. 60. The process of claim 58, said N-lauroylsarcosinate is at a concentration of from 0.001 mM and 100 mM. 61. The process of claim 55, said step of removing comprising subjecting said first debrided bone to a stream of removal solution.

Details for Patent 6,837,907

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		2021-03-28