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 tissue holding element;   advancing the device transorally into an esophageal tract of a patient;   engaging a portion of the stomach with the device;   applying a force to the portion of the stomach to displace the stomach tissue toward the patient's feet;   moving a first tissue layer and a second tissue layer together to create a fold of tissue from the stomach tissue which was displaced toward the patient's feet during the applying step;   holding the first and second tissue layers together using the tissue holding element after the moving step; and   attaching the first and second tissue layers together.   
     
     
         72 . The method of  claim 71 , wherein the applying step is carried out before completing the moving step so that the stomach tissue is displaced toward the patient's feet before forming the fold of tissue. 
     
     
         73 . The method of  claim 71 , wherein the providing step is carried out with the device including a tissue gripping element having a vacuum orifice to grip the esophageal tract. 
     
     
         74 . The method of  claim 73 , further comprising the steps of gripping the esophageal tract with the vacuum orifice, and imparting a force to the esophageal tract while the vacuum orifice grips the esophageal tract. 
     
     
         75 . The method of  claim 74 , wherein the imparting step is carried out before the applying and attaching steps to move tissue into an improved position to form a flap from the fold of tissue. 
     
     
         76 . 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. 
     
     
         77 . The method of  claim 71 , wherein the moving step is carried out so that the fold of tissue at least partially creates a flap from the stomach tissue displaced toward the patient's feet during the applying step. 
     
     
         78 . The method of  claim 71 , wherein the moving step is carried out with an intersection between the stomach and the esophageal track being formed by the fold of tissue. 
     
     
         79 . The method of  claim 71 , wherein the applying and moving steps are carried out so that the intersection is moved toward the patient's feet when creating the fold of tissue.