Invaginator for gastroesophageal flap valve restoration device
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. A method of restoring a flap of a deteriorated Grade III or Grade IV gastroesophageal flap valve associated with a stomach and esophagus, comprising:
providing an elongated member having a tissue shaper at a distal end thereof;
inflating the stomach;
gripping a tissue wall of the esophagus using an invaginator having a plurality of orifices to pull a vacuum;
gripping stomach tissue with the tissue shaper from within the stomach aboral of a Z-line;
pulling the gripped stomach tissue into a mold to form a first fold of stomach tissue;
pulling the stomach downwardly to align a fold line in the first fold of stomach tissue aboral of the Z-line;
deploying a first fastener through the first fold of stomach tissue aboral of the Z-line; and
rotating the elongated member while maintaining an axial position of the invaginator relative to the esophageal wall in order to form a sequential, second fold of stomach tis sue.
2. The method of claim 1 , wherein the first fastener extends through the first fold of stomach aboral of the Z-line so that serosa tissue is fastened to serosa tissue.
3. The method of claim 1 , further comprising deflating the stomach after deploying the first fastener.
4. The method of claim 1 , further comprising releasing the grip on the stomach tissue after the first fastener is deployed.
5. The method of claim 1 , further comprising maintaining the gripping of the tissue wall of the esophagus and repeating the inflating, gripping of stomach tissue, pulling, deploying, and rotating steps for forming the second fold of stomach tissue and deploying a second fastener displaced from the first fastener.
6. The method of claim 1 , wherein the inflating step includes inflating the stomach to a first pressure, wherein the method further comprises visualizing the stomach from within the stomach after inflating the stomach to the first pressure, and increasing inflation pressure within the stomach to a second pressure after visualizing the stomach before gripping stomach tissue.