Bioactive Scaffold for Therapeutic and Adhesion Prevention Applications

Abstract

A device for inhibiting adhesion of apposing human body tissue layers includes a scaffold having a designated mean pore size, relative density, and degradation half-life. The scaffold may be operably positioned between apposing tissue layers, such as proximate adhesiogenic layers at a wound site, so as to permit remesothelialization of the tissue without formation of fibrous adhesions. The scaffold device of the invention inhibits adhesion formation by promoting contractile cell migration away from the wound site for a predetermined period of time. The invention further relates to device and methods for promoting internal tissue regeneration, and for provision and/or dispensation of therapeutic and/or diagnostic agents in vivo.

1 . A method for inhibiting adhesion of apposing internal human body tissue layers, said method comprising:
 (a) providing a scaffold prepared by co-precipitation of collagen and a glycosaminoglycan (GAG), followed by lyophilization, said scaffold having a first collagen-GAG portion that is more porous than a second collagen-GAG portion of said scaffold; and   (b) positioning said scaffold between said opposing tissue layers.   
     
     
         2 . A method as in  claim 1 , further including incorporating a dispensable therapeutic agent with said scaffold. 
     
     
         3 . A method as in  claim 2  wherein said dispensable therapeutic agent is selected from the group consisting of antibiotics, cytokines, anti-inflammatory drugs, cytostatic agents, fibrinolytic agents, corticosteroids, and combinations thereof. 
     
     
         4 . A method as in  claim 1  including a bioadhesive disposed on at least one surface of said scaffold. 
     
     
         5 . A method as in  claim 1 , including grafting said scaffold to at least one of the tissue layers. 
     
     
         6 . A method as in  claim 1 , further including incorporating a diagnostic agent with said scaffold. 
     
     
         7 . A method as in  claim 1  wherein the first collagen-GAG portion has a first mean pore size, and the second collagen-GAG portion has a different mean pore size. 
     
     
         8 . A method for dispensing a therapeutic agent, said method comprising:
 (a) providing a scaffold that is prepared by co-precipitation of collagen and a glycosaminoglycan (GAG), followed by lyophilization, said scaffold having a first collagen-GAG portion that is more porous than a second collagen-GAG portion of said scaffold;   (b) incorporating the therapeutic agent with said scaffold; and   (c) implanting said scaffold in a human body.