Method of preparing an immunologically inert graft material from body tissue and material made with the method

Abstract

A method of preparing an immunologically inert graft material from body tissue is described. Body tissue having cellular material disposed within an extracellular matrix is lysed by alternatingly exposing the body tissue to a hypertonic solution and a hypotonic solution to create an osmotic pressure gradient across the cellular material. Antigens present in the body tissue are deactivated by exposing the body tissue to a bleach solution, sodium hydroxide, or an iodophor solution. The body tissue is stabilized by soaking the body tissue in an isotonic solution. In addition, an immunologically inert collagenic graft material produced by a method is disclosed.

1 . A method of preparing an immunologically inert graft material from body tissue, the method comprising steps of: 
 lysing body tissue having cellular material disposed within an extracellular matrix by alternatingly exposing the body tissue to a hypertonic solution and a hypotonic solution to create an osmotic pressure gradient across the cellular material;    deactivating antigens present in the body tissue by exposing the body tissue to at least one of: (i) a bleach solution, (ii) sodium hydroxide, and (iii) an iodophor solution; and    stabilizing the body tissue by soaking the body tissue in an isotonic solution.    
     
     
         2 . The method of  claim 1  wherein the lysing step comprises utilizing hypertonic and hypotonic solutions that are ionic and non-ionic aqueous solutions, respectively.  
     
     
         3 . The method of  claim 1  wherein the lysing step comprises utilizing an aqueous saline solution as the hypertonic solution and water as the hypotonic solution.  
     
     
         4 . The method of  claim 1  wherein the lysing step comprises exposing the body tissue to a series of an increasingly hypertonic saline solutions.  
     
     
         5 . The method of  claim 1  wherein the deactivating step comprises exposing the body tissue to a solution selected from a group consisting of: sodium hydroxide, potassium hydroxide, ammonium hydroxide, calcium hydroxide, sodium dodecylsulfate, urea, phenol, and formic acid.  
     
     
         6 . The method of  claim 1  wherein the deactivating step comprises exposing the body tissue to a solution selected from a group consisting of: hydrogen peroxide, peracetic acid, perbenzoic acid, benzoyl peroxide, sodium peroxide, and potassium permanganate.  
     
     
         7 . The method of  claim 1  wherein the deactivating step comprises exposing the body tissue to an iodophor solution that comprises povidone-iodine.  
     
     
         8 . The method of  claim 1  wherein the deactivating step comprises exposing the body tissue to a bleach solution that comprises one of sodium hypochlorite and calcium hypochlorite.  
     
     
         9 . The method of  claim 1  further comprising a step of freezing the body tissue in a bleach solution prior to performing the lysing step.  
     
     
         10 . The method of  claim 1  further comprising a step of exposing the body tissue to a sodium hydroxide solution.  
     
     
         11 . The method of  1  further comprising a step of exposing the body tissue to a hydrogen peroxide solution.  
     
     
         12 . The method of  claim 1  further comprising a step of exposing the body tissue to an antibiotic solution.  
     
     
         13 . The method of  claim 12  wherein the antibiotic solution comprises kanamycin.  
     
     
         14 . The method of  claim 1  further comprising a step of exposing the body tissue to an anti-microbial solution.  
     
     
         15 . The method of  claim 1  further comprising a step of exposing the body tissue to an anti-viral solution.  
     
     
         16 . The method of  claim 1  further comprising a step of exposing the body tissue to a bactericidal agent.  
     
     
         17 . An immunologically inert collagenic graft material produced by performing steps of: 
 procuring body tissue from one of an autolugous, heterologous or allogenic source;    washing the body tissue in a detergent solution;    treating the body tissue with at least one anti-microbial, antibacterial, or anti-viral solution;    soaking the body tissue in a hypertonic solution;    soaking the body tissue in a solution comprising a caustic reagent; and    treating the body tissue with a hydrogen peroxide solution.    
     
     
         18 . The immunologically inert collagenic_graft material of  claim 17  wherein the soaking the body tissue in hypertonic solution step comprises exposing the body tissue to a series of an increasingly hypertonic saline solutions.  
     
     
         19 . The immunologically inert collagenic_graft material of  claim 17  further comprising a step of freezing the body tissue in a bleach solution prior to performing the washing step.