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 manipulating gastroesophageal tissue, 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 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 fold of stomach tissue, the fold of stomach tissue forming an intersection between the esophageal tract and the stomach.   
     
     
         72 . The method of  claim 72 , wherein:
 the engaging step is carried out with the stomach tissue being positioned adjacent the intersection between the esophageal tract and the stomach associated with a disease state;   the displacing step is carried out with the fold of tissue creating the intersection between the esophageal tract and the stomach using the stomach tissue displaced during the displacing step.   
     
     
         73 . The method of  claim 71 , wherein:
 the displacing step is carried out with the stomach tissue being displaced toward a distal end of the longitudinal member by the tissue engaging element when moving toward the retracted position.   
     
     
         74 . The method of  claim 71 , wherein:
 the introducing step is carried out with the device having a mold coupled to the longitudinal member, the mold being movable from a first position to a second position, the mold being configured to mold the stomach tissue displaced during the displacing step when moving from the first position to the second position; and   the displacing step being carried out to draw the stomach tissue into the mold.   
     
     
         75 . The method of  claim 74 , further comprising the step of:
 molding the stomach tissue by moving the mold from the first position to the second position, the molding step being carried out before completing the fastening step.   
     
     
         76 . The method of  claim 75 , wherein:
 the molding step being carried out with the mold being shaped to form the cardiac notch when moved to the second position.   
     
     
         77 . The method of  claim 74 , wherein:
 the displacing step is carried out with the tissue engaging element extending from the mold when in the extended position, the tissue engaging element moving into the mold when moving toward the retracted position.   
     
     
         78 . The method of  claim 74 , wherein:
 the introducing step is carried out with the device having a suction orifice positioned proximal to the mold.   
     
     
         79 . The method of  claim 78 , further comprising the step of:
 gripping the esophageal tract by applying suction to the suction orifice, the esophageal tract being gripped proximal to the fold of stomach tissue.   
     
     
         80 . The method of  claim 74 , wherein:
 the displacing step is carried out with the stomach tissue being positioned outside the mold and being drawn into the mold by the tissue engaging element.