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 creating a flap valve, comprising the steps of:
 providing a device having a longitudinal member, a tissue gripper, a molding element and a fixation device;   advancing the longitudinal member transorally into a patient's esophageal tract;   positioning the tissue gripper adjacent to tissue in the esophageal tract;   gripping tissue with the tissue gripper;   positioning a fold of tissue in the mold, the fold of tissue being created at a gastroesophageal junction by a first tissue layer and a second tissue layer; and   applying a downward force with the mold while the tissue gripper grips the tissue in the esophageal tract, the downward force stretching the tissue and increasing the length of the tissue between the mold and the tissue gripper; and   
       attaching the first and second tissue layers together after the applying step. 
     
     
         72 . The method of  claim 71 , wherein:
 the positioning step is carried out with the fold being created at a gastroesophageal junction   
     
     
         73 . The method of  claim 71 , wherein:
 the gripping step is carried out with the tissue gripper having at least one vacuum orifice, the gripping step being carried out by creating suction at the vacuum orifice so that the vacuum orifice grips the tissue.   
     
     
         74 . The method of  claim 71 , wherein:
 the providing step is carried out with the tissue gripper and the molding element being longitudinally movable relative to one another.   
     
     
         75 . The method of  claim 71 , wherein:
 the positioning step is carried out with the first tissue layer being a layer of the esophageal tract and the second tissue layer is a layer of the stomach.   
     
     
         76 . The method of  claim 75 , wherein:
 the applying step is carried out so that the fundus moves downward.