Chemical cleaning of biological material

Abstract

The invention is directed to collagenous tissues which have been treated to remove non-collagenous components such as cells, cellular debris, and other extracellular matrix components, such as proteoglycans and glycosaminoglycans, normally found in native tissues. Treatment of the tissue with alkali, chelating agents, acids and salts removes non-collagenous components from the collagenous tissue matrix while controlling the amount of swelling and dissolution so that the resultant collagen matrix retains its structural organization, integrity and bioremodelable properties. The process circumvents the need to use detergents and enzymes which detrimentally affect the cell compatibility, strength and bioremodelability of the collagen matrix. The collagenous tissue matrix is used for implantation, repair, or use in a mammalian host.

1 . A bioremodelable collagenous tissue matrix composition derived from native tissue, comprising: 
 telopeptide collagen;    elastin, wherein elastin is less than 10% of the total composition based on dry weight; and    non-collagenous and non-elastinous components, wherein said components are less than 5% of the total composition based on dry weight;    wherein the collagenous tissue matrix is free of detergent residues, enzymatic modification, endotoxin and cells and cellular debris; and    wherein the native tissue is selected from the group consisting of dermis, artery, vein, pericardium, heart valve, dura mater, ligament, bone, cartilage, fascia and intestine; and wherein the collagenous tissue matrix is sterile.    
   
   
       2 . The bioremodelable collagenous tissue matrix composition of  claim 1 , wherein the collagenous tissue matrix is sterile.  
   
   
       3 . A bioremodelable collagenous tissue matrix composition derived from small intestine, comprising: telopeptide collagen; 
 elastin, wherein elastin is less than 10% of the total composition based on dry weight; and    non-collagenous and non-elastinous components, wherein said components are less than 5% of the total composition based on dry weight; and    wherein the collagenous tissue matrix is free of detergent residues, enzymatic modification, endotoxin and cells and cellular debris.    
   
   
       4 . The bioremodelable collagenous tissue matrix composition of  claim 3 , wherein the collagenous tissue matrix is derived from the tunica submucosa of small intestine.  
   
   
       5 . The bioremodelable collagenous tissue matrix composition of  claim 3 , wherein the collagenous tissue matrix is chemically cleaned.  
   
   
       6 . The bioremodelable collagenous tissue matrix composition of  claim 3 , wherein the collagenous tissue matrix is sterile.  
   
   
       7 . The bioremodelable collagenous tissue matrix composition of  claim 3 , wherein the collagenous tissue matrix is layered and bonded together to form multilayer sheets, tubes, or complex shaped prostheses.  
   
   
       8 . The bioremodelable collagenous tissue matrix composition of  claim 7 , wherein the collagenous tissue matrix is crosslinked.