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 device for forming a flap in a lower portion of the esophageal tract, comprising: 
 a longitudinal member having sufficient flexibility to be delivered transorally into the esophageal tract;    a tissue holding element coupled to the longitudinal member, the tissue holding element being sized and configured to hold a fold of tissue created by moving a portion of the esophageal tract into contact with a portion of the stomach,    a tissue gripping element having a vacuum orifice to grip tissue in the esophageal tract; and    an attachment element coupled to the tissue holding element, the attachment element being configured to attach the portion of the esophageal tract to the portion of the stomach when the tissue holding element is holds the fold of tissue.    
   
   
       72 . The device of  claim 71 , wherein the tissue holder is sized and configured to hold a fold of tissue including an intersection between the stomach and the esophageal tract.  
   
   
       73 . The device of  claim 71 , wherein the tissue gripping element and the tissue holding element are movable relative to one another.  
   
   
       74 . The device of  claim 71 , wherein the tissue gripping element is movable toward the patient's feet while the vacuum orifice grips the tissue in the esophageal tract to displace the esophageal tract.  
   
   
       75 . The device of  claim 71 , further comprising a stomach engaging element configured to engage a portion of a patient's stomach and move the portion of the stomach toward the feet.  
   
   
       76 . A method of forming a flap in a lower portion of the esophageal tract, comprising the steps of: 
 providing a device having a tissue holding element;    advancing the device into an esophageal tract of a patient;    engaging a portion of the stomach with the device;    applying a force to displace the portion of the stomach toward the patient's feet;    moving a first tissue layer and a second tissue layer together to create a fold of tissue, the fold of tissue including a layer of the stomach and a layer of the esophageal tract and the intersection of the stomach and the esophageal tract;    holding the first and second tissue layers together using the tissue holding element after the applying step; and    attaching the first and second tissue layers together while holding the first and second tissue layers together.    
   
   
       77 . The method of  claim 76 , wherein the moving step is carried out with the intersection between the stomach and the esophageal track being formed by the fold of tissue.  
   
   
       78 . The method of  claim 76 , wherein the applying step is carried out before completing the moving step so that the portion of the stomach is displaced toward the feet before forming the fold of tissue.  
   
   
       79 . The method of  claim 76 , wherein the providing step is carried out with the device including a tissue gripping element having a vacuum orifice to grip the esophageal tract.  
   
   
       80 . The method of  claim 79 , further comprising the step of imparting a force to the esophageal tract while the vacuum orifice grips the esophageal tract.  
   
   
       81 . The method of  claim 80 , wherein the imparting step is carried out before the moving step to move tissue into an improved position for forming a flap from the fold of tissue.  
   
   
       82 . The method of  claim 76 , wherein the providing step is carried out with the tissue gripping element being movable relative to the tissue holding element.