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 device may include the invaginator device for gripping and maneuvering esophageal tissue to aid restoration of the gastroesophageal flap, and may include the tissue fixation device.

1 - 70 . (canceled)  
   
   
       71 . A method of forming a flap valve in a lower portion of the esophageal tract, comprising the steps of: 
 providing a device having a longitudinal member, a tissue holding element, and a tissue gripping element having a vacuum orifice, the tissue holding element being coupled to the longitudinal member;    advancing the device transorally into an esophageal tract of a patient;    gripping tissue in the esophageal tract by applying suction to the vacuum orifice so that the vacuum orifice grips the tissue in the esophageal tract;    moving a first tissue layer and a second tissue layer together to create a fold of tissue, the first tissue layer being a portion of the esophageal tract and the second tissue layer being a portion of the stomach;    holding the first and second tissue layers together using the tissue holding element; and    attaching the first and second tissue layers together.    
   
   
       72 . The method of  claim 71 , wherein the moving step is carried out with the fold of tissue forming an intersection between the stomach and the esophageal tract.  
   
   
       73 . The method of  claim 72 , wherein the moving step is carried out with the intersection between the stomach and the esophageal track being formed by the fold of tissue.  
   
   
       74 . The method of  claim 71 , further comprising the step of displacing stomach tissue toward the patient's feet before the holding step.  
   
   
       75 . The method of  claim 74 , wherein the moving step is carried out with the fold of tissue being formed from the stomach tissue displaced toward the patient's feet during the displacing step.  
   
   
       76 . The method of  claim 74 , wherein the displacing step is carried out while the vacuum orifice grips the tissue in the esophageal tract.  
   
   
       77 . The method of  claim 71 , wherein the providing step is carried out with the tissue gripping element being movable relative to the tissue holding element.  
   
   
       78 . The method of  claim 71 , further comprising the step of applying a force to the esophageal tract while the vacuum orifice grips the esophageal tract.  
   
   
       79 . The method of  claim 78 , wherein the applying step is carried out before the moving step to move tissue into an improved position when forming a flap from the fold of tissue during the holding and attaching steps.