Transoral endoscopic gastroesophageal flap valve restoration device, assembly, system and method

A transoral endoscopic gastroesophageal flap valve restoration assembly, the assembly comprising:

• a longitudinal member, a portion of which is arranged for transoral placement into a stomach, and that carries a mold having a shape related to a gastroesophageal flap;
• a tissue shaper that non-invasively grips and urges tissue into the mold;
• and
• a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

A transoral endoscopic gastroesophageal flap valve restoration assembly, comprising:

• a longitudinal member, a portion of which is arranged for transoral placement into a stomach, and that carries a mold having a shape related to a gastroesophageal flap;
• a tissue gripper that non-invasively grips with a vacuum and urges tissue to take a shape related to the mold;
• an invaginator having a tissue gripper to vacuum grip esophageal tissue and allow a force to be imparted to the vacuum gripped esophageal tissue;
• and
• a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

A transoral endoscopic gastroesophageal flap valve restoration assembly, comprising:

• a longitudinal member, a portion of which is arranged for transoral placement into a stomach, that carries a mold having a shape related to a gastroesophageal flap, and that has a channel arranged to maintain an orientation with an endoscopic device and a lumen arranged to carry a tissue fixation device;
• a tissue gripper that non-invasively grips with a vacuum and urges tissue to take a shape related to the mold, the tissue gripper including a member carried on the longitudinal member that has a plurality of vacuum orifices on a surface arranged to grip tissue and hold the tissue proximate to a molding surface of the mold;
• and
• a tissue fixation device that maintains the molded stomach tissue in a shape approximating a gastroesophageal flap.

A self-closing tissue fixation device for effecting tissue geometry, the device comprising:

• an elongated member having a first end portion and a second end portion, the first end portion terminating in a tissue-piercing end;
• and
• a connecting portion extending between the first and second end portions, the connecting portion having a first and second joining portions separated by a pressure portion,
• the elongated member having an initial stressed and distorted configuration that, as portions beginning with the first end portion are deployed from a lumen by a force pushing on the second end portion, steers the elongated member into and through tissue proximate to the lumen and assumes a final configuration, wherein the elongated member forms an interior perimeter holding together the tissue enclosed within the perimeter.

A method of transoral restoration of a gastroesophageal flap valve, the method including the steps of:

• selecting a portion of intraluminal fundus tissue that is proximate to the cardiac notch;
• shaping the tissue into a shape resembling a gastroesophageal flap;
• and
• fixating the shaped tissue into a shape approximating a gastroesophageal flap.

A method of transoral restoration of a gastroesophageal flap valve, the method including the steps of:

• providing at least one self-closing tissue fixation device for effecting gastroesophageal geometry;
• providing a longitudinal member carrying a mold having a shape related to a gastroesophageal flap valve, and a tissue shaper that urges gastric tissue to take a shape related to the mold, the tissue gripper including a member having a plurality of vacuum orifices on a surface arranged to grip tissue and to hold the tissue proximate to a molding surface of the mold;
• gripping-gastric-tissue-from the fundus region of the stomach proximate to the cardiac notch with the tissue shaper and urging the gastric tissue into a shape related to a gastroesophageal flap;
• and
• deploying at least one tissue fixation device into the gastric tissue to maintain the gastric tissue in a shape approximating a gastroesophageal flap.