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.

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.  
     
     
         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, tripotassioum 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 , said contacting, comprising: 
 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 incubating 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° C. to 65° C.  
     
     
         13 . The process of  claim 3 , said alkaline solution concentration is from 0.1 N to 1.0 N.  
     
     
         14 . The process of  claim 3 , said alkaline solution concentration is from 0.1 M to 25.0 M.  
     
     
         15 . The process of  claim 14 , said alkaline solution concentration is from 0.5 M to 20.0 M.  
     
     
         16 . The process of  claim 14 , said alkaline solution concentration is from 0.5 M to 3.0 M.  
     
     
         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 disinfectant 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 21 , said mechanically removing comprising: injecting air between said soft tissue and said bone; and subjecting said bone and said soft tissue to a flow of aqueous removal solution.  
     
     
         23 . The process of  claim 21 , said mechanical means comprising a scraper.  
     
     
         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 claims  1 .  6 ,  21 , or  22 , wherein any one or more or said steps of removing, mechanically removing, injecting, and subjecting, is performed simultaneously or sequentially.  
     
     
         27 . The process of  claim 22 , 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.  
     
     
         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.  
     
     
         34 . The process of any one of claims  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 . The process of claims  32  or  33 , said one or more debriding agents comprise a granular alkaline agent.  
     
     
         39 . The process of  claim 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 38 , said granular alkaline agent comprising dry sodium hydroxide.  
     
     
         43 . The process of any one of claims  1 ,  32 , or  33 , said contacting comprising contacting in a closed container.  
     
     
         44 . The process of  claim 43 , 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 43 , 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 . The process of  claim 32 , said debriding agents further comprising one or more debriding solutions.  
     
     
         50 . The process of  claim 49 , said one or more debriding solutions comprise one or more alkaline solutions.  
     
     
         51 . The process of any one of claims  1 ,  6 ,  32 , or  33 , said contacting is carried out from 30 minutes to 18 hours.  
     
     
         52 . The process of any one of claims  32  or  33 , further comprising agitating said bone with said one or more debriding agents.  
     
     
         53 . The process of  claim 52 , said agitating comprising rolling.  
     
     
         54 . The process of  claim 53 , said rolling is performed at a rate of from 10 to 100 revolutions per minute.  
     
     
         55 . The process of  claim 52 , said debriding agent is present at a volume sufficient to cover said bone during said agitation.  
     
     
         56 . The process of any one of claims  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 . Debrided bone produced by the process as claimed in any one of claims  1 ,  6 ,  32 , or  33 .  
     
     
         62 . Debrided bone produced by the process as claimed in  claim 60 .  
     
     
         63 . The debrided bone of  claim 61  substantially free from bacterial, fungal, viral, microbial, and prion contamination.  
     
     
         64 . The debrided bone of  claim 62  substantially free from bacterial, fungal, viral, microbial, and prion contamination.  
     
     
         65 . The process of  claim 10 , said subjecting is carried out for a period of time of from 10 minutes to 60 minutes.  
     
     
         66 . The process of  claim 65 , 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.  
     
     
         67 . The process of  claim 66 , said step of removing comprising subjecting said first debrided bone to a stream of removal solution.