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;   moving a first tissue layer and a second tissue layer together to create a fold of tissue, the first tissue layer being a part of the esophagus and the second tissue layer being a part of the stomach;   applying a force to displace the first and second tissue layers toward the patient's feet using the tissue holding element;   holding the first and second tissue layers together using the tissue holding element; and   attaching the first and second tissue layers together while holding the first and second tissue layers together with the tissue holding element.   
     
     
         72 . The method of  claim 71 , wherein:
 the providing step is carried out with the tissue holding element having at least one movable arm; and   the holding step is carried out by moving the at least one arm to a closed position.   
     
     
         73 . The method of  claim 71 , wherein:
 the applying step is carried out with the tissue holder applying the force to displace the second tissue layer.   
     
     
         74 . The method of  claim 73 , wherein:
 the applying step is carried out with the tissue holder applying the force to the second tissue layer.