Invaginator for gastroesophageal flap valve restoration device

Abstract

An assembly for restoring a gastroesophageal flap valve includes a restoration device substantially free for rotation. The assembly comprises an elongated member configured to be fed through a throat, down an adjoining esophagus and into an associated stomach. The elongated member has a distal end. The assembly further comprises a gastroesophageal flap valve restoration device carried on the distal end of the elongated member for placement in the stomach, and an invaginator carried by the elongated member. The invaginator is configured to grip the esophagus and the elongated member and invaginator are coupled for restricted relative axial movement and substantially free relative rotational movement.

1 - 61 . (canceled) 
   
   
       62 . A method of forming a flap valve, comprising:
 providing a device having a longitudinal member and a tissue shaping element carried on the longitudinal member, the tissue shaping element being pivotally coupled to the longitudinal member, the device also including a tissue gripper having a tension element, the device also having a guide structure being movable between a first position and a second position, the guide structure supporting the tension element when in the first position, the guide structure releasing support of the tension element when moved from the first position to the second position;   advancing the device through the esophagus of a patient;   gripping stomach tissue with the tissue gripper while the guide structure is in the first position to provide support to the tension element;   moving the guide structure to the second position to release support of the tension element after the gripping step; and   pulling the stomach tissue by applying tension to the tension element;   closing the tissue shaping element to form a fold of tissue in the tissue shaping element from a first tissue layer and a second tissue layer; and   fastening the first and second tissue layers together.   
   
   
       63 . The method of  claim 62 , wherein:
 the providing step is carried out with the tension element being a cable.   
   
   
       64 . The method of  claim 62 , wherein:
 the providing step is carried out with the tissue gripper including a helical coil at a distal end; and   the gripping step is carried out with the helical coil being manipulated to engage the stomach tissue.   
   
   
       65 . The method of  claim 62 , further comprising the step of:
 securing the device to the esophageal tract during the pulling step.   
   
   
       66 . The method of  claim 62 , wherein:
 the providing step is carried out with the device having a vacuum opening; and   the securing step is carried out by applying suction to the vacuum opening so that the vacuum opening adheres to the esophageal tract.   
   
   
       67 . The method of  claim 62 , wherein:
 the fastening step is carried out with the fold of tissue forming a junction between the esophageal tract and the stomach.   
   
   
       68 . The method of  claim 62 , wherein:
 the pulling step is carried out with the tension element pulling the stomach tissue toward the patient's feet.