Device for Gastric Feeding and Drainage Via an Artificial Stoma

Abstract

The invention describes a closure device for the provision of freshly created gastric feeding fistulas, the basis of the design of the device being an introverted balloon that allows a sealing and hemostatic axial traction movement on the fistula that is to be sealed, the concentric balloon ends which run transmurally through the stomach and abdominal wall being arranged in a special seal-promoting and hemostatic manner.

1 . A device ( 10 ) for the creation of an artificial stoma ( 18 ) into a living body ( 20 ) comprising:
 a thin foil ( 22 ) having a first and a second end ( 24 ,  26 ) with a length ( 28 ) disposed therebetween, the thin foil ( 22 ) being arranged in a manner such that one of said ends is backfolded or introverted into the other of said ends, the thin foil ( 22 ) further characterized as formed of a material that exhibits little volume expansibility such that it is stable in shape under elevated balloon filling pressures; and   a cap ( 30 ) having at least one port ( 34 ) therethrough, the cap ( 30 ) securely capturing each end ( 24 ,  26 ) of the foil ( 22 ) therein, the port terminating between the first and second foil ends ( 24 ,  26 ) within a space ( 32 ) created by introversion of the foil ( 22 ) so that application of an inflation source ( 44 ) to the port ( 34 ) causes the length ( 28 ) of said foil ( 22 ) to inflate and form a generally torus shaped balloon ( 36 ) having exterior and interior externally facing concentric surfaces ( 38 ,  40 ) such that that the interior facing surface ( 40 ) defines a passage ( 42 ) through the device; and   wherein a bulge ( 54 ) is formed into the exterior surface ( 38 ) upon inflation of the balloon ( 36 ), the bulge ( 54 ) being proximate the end ( 24 ) of the foil ( 22 ) and adjacent the cap ( 30 ) securing each end ( 24 , 26 ) of the foil ( 22 ).   
     
     
         2 . The device ( 10 ) of  claim 1  wherein the torus shaped balloon ( 36 ) is adapted to exert an increasingly greater force upon increasing inflation, the force being exerted axially along the foil ( 22 ) and directed toward the cap ( 30 ). 
     
     
         3 . The device ( 10 ) of  claim 1  adapted to be placed in the living body ( 20 ) by engaging a guide wire previously situated in the living body ( 20 ). 
     
     
         4 . The device ( 10 ) of  claim 1 , wherein the thin foil ( 22 ) is made of a mechanically low-compliant material. 
     
     
         5 . The device ( 10 ) of  claim 1 , wherein the thin foil ( 22 ) is made of a thermoplastic polyurethane. 
     
     
         6 . The device ( 10 ) of  claim 1 , wherein the exterior surface ( 38 ) exceeds the diameter of the widest section of the artificial stoma ( 18 ) perforation by at least about 10%. 
     
     
         7 . The device ( 10 ) of  claim 1 , wherein the exterior surface ( 38 ) exceeds the diameter of the widest section of the artificial stoma ( 18 ) perforation by an amount ranging from about 25% to about 50%. 
     
     
         8 . The device ( 10 ) of  claim 1 , wherein the exterior surface ( 38 ) exceeds the diameter of the widest section of the artificial stoma ( 18 ) perforation by an amount up to about 75%.