Tissue adhesive sealant

Abstract

A tissue adhesive sealant includes a cross-linkable protein in a solution that when combined with a cross-linking agent solution including an aldehyde and amino acid containing species reactive with the aldehyde cross-links to form a seal. The sealant is well suited for bonding tissue alone or in combination with a patch. The ratio between the aldehyde and the amino acid containing species is between 20:1 and 1:1 on an aldehyde moiety:amino acid or peptide subunit molar basis. Particularly strong seals are formed when the protein and cross-linking agent are present in a molar ratio of between 15:1 and 1:1.

1 . A process for preparing a cross-linking agent component of a tissue adhesive sealant comprising the steps of: 
 preparing an aqueous solution of glutaraldehyde;    thereafter, stirring into said solution a compound having the formula                          where Q is CH 2  or a nullity; R 1  is independently in each occurrence H, Na, K, C 2 -C 6  alkyl; R 2  is independently H, C 1 -C 20  alkyl group, a C 0 -C 4  alkyl group having a substituent selected sulfonate, carboxylate, hydroxyl, quaternary amines, a radio isotopic ion, a magnetically detectable ion, an antibiotic moiety and an antibody; and n is an integer between 1 and 6 inclusive; hydrohalide salts thereof; and combinations thereof until said compound is dissolved; and    allowing sufficient time for said compound to react with said glutaraldehyde to form an oligomer.    
   
   
       2 . The process of  claim 1  further comprising the step of modifying the pH of said aqueous solution of glutaraldehyde to between 2 and 11.  
   
   
       3 . The process of  claim 1  wherein said solution is heated while said compound reacts with said glutaraldehyde.  
   
   
       4 . The process of  claim 1  further comprising the step of modifying the pH of said aqueous solution of glutaraldehyde to between 8 and 11.  
   
   
       5 . The process of  claim 1  wherein R 1  and R 2  in every occurrence is H.