Pericardial anti-adhesion patch

Abstract

The present invention is directed to an anti-adhesion patch, which is constructed using a tissue equivalent technique. The anti-adhesion patch comprises a collagenous material and at least one non-living cellular component. Also provided is a method for preventing tissue adhesions between organs and other tissues being operated upon during surgical procedures by utilizing the anti-adhesion patch disclosed herein.

What is claimed is:  
     
         1 . An anti-adhesion patch, comprising: 
 a collagenous material; and    at least one non-living cellular component.    
     
     
         2 . The anti-adhesion patch of  claim 1 , wherein said collagenous material is collagen type I or a combination of collagen type I and a co-component.  
     
     
         3 . The anti-adhesion patch of  claim 2 , wherein said co-component is selected from the group consisting of elastin, interstitial collagens, collagen type III, V and IX, glycoproteins and proteoglycans.  
     
     
         4 . The anti-adhesion patch of  claim 1 , wherein said collagenous material is from a natural source or a recombinant source.  
     
     
         5 . The anti-adhesion patch of  claim 1 , wherein said non-living cellular component is from a natural source or a recombinant source.  
     
     
         6 . The anti-adhesion patch of  claim 5 , wherein said non-living cellular component from a natural source is human connective tissue cell.  
     
     
         7 . The anti-adhesion patch of  claim 6 , wherein said human connective tissue cell is a fibroblast cell or a vascular smooth muscle cell.  
     
     
         8 . The anti-adhesion patch of  claim 7 , wherein said fibroblast cell is a dermal fibroblast cell.  
     
     
         9 . The anti-adhesion patch of  claim 5 , wherein said non-living cellular component from a recombinant source is an engineered cell.  
     
     
         10 . A method of constructing an anti-adhesion patch, comprising the steps of: 
 (a) mixing human connective tissue cells with a collagenous material;    (b) incubating the resulting mixture in a matrix organization medium to stimulate the cells to adapt to and organize the collagenous material into a mono-cellular tissue equivalent having desirable dimensions and mechanical properties;    (c) treating the tissue equivalent to eliminate the cells; and    (d) confirming the absence of viable cells in the tissue equivalent after the treatment, wherein said tissue equivalent may be used as an anti-adhesion patch.    
     
     
         11 . The method of  claim 10 , wherein said collagenous material is in an acid solution and first neutralized at 4° C. before the mixing step.  
     
     
         12 . The method of  claim 11 , wherein said acidic solution is hydrochloric solution.  
     
     
         13 . The method of  claim 10 , wherein said human connective tissue cell is a fibroblast cell or a vascular smooth muscle cell.  
     
     
         14 . The method of  claim 13 , wherein said fibroblast cell is a dermal fibroblast cell.  
     
     
         15 . The method of  claim 10 , wherein said collagenous material is collagen type I or a combination of collagen type I and a co-component.  
     
     
         16 . The method of  claim 15 , wherein said co-component is selected from the group consisting of elastin, interstitial collagens, collagen type III, V and IX, glycoproteins and proteoglycans.  
     
     
         17 . The method of  claim 10 , wherein said collagenous material is from a natural source or a recombinant source.  
     
     
         18 . The method of  claim 10 , wherein said matrix organization medium contains fetal bovine serum.  
     
     
         19 . The method of  claim 10 , wherein said matrix organization medium is a serum-free cocktail of growth factors selected from the group consisting of fibroblast growth factor (FGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor beta (TGF β ) and a mixture thereof.  
     
     
         20 . The method of  claim 19 , wherein said cocktail of growth factors are in the presence of growth promoters.  
     
     
         21 . The method of  claim 20 , wherein said growth promoter includes transferrin and insulin.  
     
     
         22 . The method of  claim 10 , wherein the cell-elimination treatment includes nutrient deprivation, antibiotics treatment and anti-mitotics treatment.  
     
     
         23 . The method of  claim 22 , wherein said antibiotics includes puromycin, amphoteracin and mitomycin.  
     
     
         24 . The method of  claim 22 , wherein said anti-mitotics is 5-flurouracil.  
     
     
         25 . A method for preventing tissue adhesions between organs and other tissues being operated upon during surgical procedures, comprising the step of: 
 attaching an anti-adhesion patch to one of the surfaces of the tissues being operated upon, wherein said anti-adhesion patch comprises a collagenous material and at least one non-living cellular component, wherein said anti-adhesion patch participates in formation of adhesion and is biodegradable during the recovery.    
     
     
         26 . The method of  claim 25 , wherein said tissue being operated upon is a heart  
     
     
         27 . The method of  claim 25 , wherein said anti-adhesion patch is attached to the traumatized tissues using a tissue glue.  
     
     
         28 . The method of  claim 27 , wherein said tissue glue is a fibrin tissue glue or another type of bio-adhesive.  
     
     
         29 . The method of  claim 28 , wherein said another type of bio-adhesive is Nitinol Coupler.