Transoral endoscopic gastroesophageal flap valve restoration device, assembly, system and method

Abstract

The invention provides a device, assembly, and method for transoral endoscopic restoration of a gastroesophageal flap valve. The invention also provides a self-steering and self-closing tissue fixation device for tissue fixation, and an invaginator device for gripping and maneuvering tissue. The restoration device includes a longitudinal member arranged for transoral placement into a stomach, a tissue shaper carried on the longitudinal member that causes stomach tissue to assume a shape related to a gastroesophageal flap, and a tissue fixation device that maintains the shaped stomach tissue in a shape approximating a gastroesophageal flap. The tissue shaper may include a mold. The gastroesophageal flap may have a length greater than two centimeters and sufficient to cover its associated stomach opening.

1 - 30 . (canceled)  
     
     
         31 . A transoral gastroesophageal flap valve restoration device, the device comprising: 
 a longitudinal member, a portion of which is arranged for transoral placement through an esophagus and into a stomach substantially in line with the esophagus;    a tissue shaper carried on the longitudinal member that shapes stomach tissue to assume a shape of a restored gastroesophageal flap;    a tissue gripper arranged to extend away from the longitudinal member, to grip stomach tissue at a location displaced from the longitudinal member, and to pull gripped stomach tissue into the tissue shaper immediately adjacent the longitudinal member; and    a tissue fixation device that maintains the restored gastroesophageal flap.    
     
     
         32 . The device of  claim 31 , wherein the tissue gripper is arranged to pull the gripped stomach tissue in an aboral direction into the tissue shaper.  
     
     
         33 . The device of  claim 31 , wherein the tissue shaper comprises first and second opposed members arranged to receive the gripped tissue there between.  
     
     
         34 . The device of  claim 33 , wherein the first and second members are hingedly coupled together.  
     
     
         35 . The device of  claim 31 , wherein the gripper is arranged to grip the stomach tissue at a distance from the longitudinal member which is greater then two centimeters.  
     
     
         36 . The device of  claim 35 , wherein the distance is greater than four centimeters.  
     
     
         37 . The device of  claim 35 , wherein the distance is between four and five centimeters.  
     
     
         38 . The device of  claim 31 , wherein the shaper is carried on the distal end of the longitudinal member.  
     
     
         39 . A method of transoral restoration of a gastroesophageal flap valve, the method including the steps of: 
 gripping stomach tissue from within the stomach at a location displaced from the esophageal opening to the stomach;    pulling the gripped stomach tissue in a direction aboral of the esophageal opening and into a position juxtaposed to the esophageal opening;    shaping the tissue into a shape resembling a gastroesophageal flap; and    fixating the shaped tissue into a shape approximating a restored gastroesophageal flap.    
     
     
         40 . The method of  claim 39 , wherein the gripping step includes gripping the stomach tissue at a location which is greater then two centimeters from the esophageal opening.  
     
     
         41 . The method of  claim 39 , wherein the gripping step includes gripping the stomach tissue at a location which is greater then four centimeters from the esophageal opening.  
     
     
         42 . The method of  claim 39 , wherein the gripping step includes gripping the stomach tissue at a location which is between four and five centimeters from the esophageal opening.  
     
     
         43 . The method of  claim 39 , wherein the fixating step includes stapling.