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 gastroesophageal flap valve, comprising the steps of:
 Introducing a device through an esophageal tract and into a stomach of a patient, the device having a longitudinal member and a tissue engaging element coupled to the longitudinal member, the tissue engaging element being movable from a retracted position to an extended position;   engaging stomach tissue with the tissue engaging element, the tissue engaging element moving from the retracted position to the extended position when engaging the stomach tissue;   displacing the stomach tissue into the stomach to form a first fold of tissue using the stomach tissue, the displacing step being carried out by moving the tissue engaging element toward the retracted position after the engaging step; and   fastening the stomach tissue together after the displacing step to secure the first fold of stomach tissue, the stomach tissue forming a first part of an intersection between the esophageal tract and the stomach;   rotating the tissue engaging element to a different position; and   repeating the engaging, displacing, fastening and rotating steps to create additional parts of the intersection between the esophageal tract and the stomach until a gastroesophageal flap valve is formed.   
     
     
         72 . The method of  claim 71 , wherein:
 the rotating step is carried out with the different position being radially spaced from a prior position on the gastroesophageal flap valve.   
     
     
         73 . The method of  claim 71 , wherein:
 the engaging step is carried out with the stomach tissue being positioned adjacent an existing intersection between the esophageal tract and the stomach in a disease state; and   the displacing steps being carried out with the fold of tissue recreating the intersection between the esophageal tract and the stomach using the stomach tissue displaced during the displacing step.   
     
     
         74 . The method of  claim 71 , wherein:
 the introducing step is carried out with the device having a mold, the mold including a portion of the longitudinal member; and   the fastening steps being carried out with the fold of tissue being in contact with the portion of the longitudinal member which forms part of the mold.   
     
     
         75 . The method of  claim 74 , wherein:
 the fastening step is carried out with fold of tissue which is in contact with the portion of the longitudinal member forming a portion of the esophageal tract using the stomach tissue displaced during the displacing step.   
     
     
         76 . The method of  claim 71 , further comprising the step of:
 molding the stomach tissue by moving a mold from the first position to the second position, the molding step being carried out before completing the fastening step.   
     
     
         77 . The method of  claim 76 , wherein:
 the molding step being carried out to form the cardiac notch using the stomach tissue displaced during the displacing step; and   the displacing step being carried out with the stomach tissue initially being positioned outside the mold and being drawn into the mold by the tissue engaging element.   
     
     
         78 . The method of  claim 76 , wherein:
 the introducing step is carried out with the tissue engaging element extending from the mold when in the extended position, the tissue engaging element being moved into the mold when moving from the extended position to the retracted position.   
     
     
         79 . The method of  claim 71 , wherein:
 the rotating step being carried out by rotating the longitudinal member together with the tissue engaging element.