Perorally removeable anti-reflux valve implantation

The method of claim 36, wherein the prosthesis comprises:

• an annular body;
• a valve depending from the annular body, said valve allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents;
• and
• wherein said plurality of retractable spikes are spaced along a circumference of the annular body adjacent one end thereof.

The method of claim 36, wherein the prosthesis includes an annular body and retractable radial spikes therefrom, and wherein the tool comprises:

• an inner tube and an outer tube, said tubes being generally concentrically aligned;
• a nipple secured to a distal end of the inner tube, the nipple configured to be releasably coupled with the annular body during said positioning;
• and
• the headpiece secured to a distal end of the outer tube to engage the retractable spikes and outwardly extend them into position during said deployment by advancing the headpiece into abutment with the nipple.

A method for using a tool to perorally implant an anti-reflux prosthesis in an esophagus, the method comprising the steps of:

• mounting the anti-reflux valve prosthesis onto a headpiece of the tool;
• positioning the anti-reflux valve prosthesis in the esophagus;
• deploying a plurality of radial spikes of the prosthesis;
• pulling a vacuum across a longitudinal passage of the tool;
• and
• drawing a lumen of the esophagus inwardly to facilitate impaction of the spikes.

A method for implanting an anti-reflux valve prosthesis in an esophagus, the method comprising the steps of:

• perorally inserting and positioning the anti-reflux valve prosthesis into the esophagus;
• deploying a plurality of spikes, the spikes depending radially from the anti-reflux prosthesis;
• and
• impaling the esophagus upon the spikes to hold the prosthesis in place.

A method for using a tool for implanting an anti-reflux valve prosthesis, wherein

• (A) the prosthesis comprises
• (1) an internally threaded annular body comprising a biologically inert polymer,
• (2) a valve depending from the annular body for allowing orthograde passage therethrough and inhibiting retrograde passage of gastric contents, and
• (3) a plurality of substantially rigid spikes spaced along a circumference of the annular body adjacent a proximal end thereof and extending radially outwardly from the annular body, each spike comprising a tip at a free end thereof and a base at the other end attached to the annular body, wherein each spike is temporarily inwardly bendable for implantation and has memory to return to the radially outwardly extending position, and
• (B) the tool comprises
• (1) an inner tube,
• (2) a nipple secured to a distal end of the inner tube for releasably threadably coupling the annular body,
• (3) a handle secured adjacent to a proximal end of the inner tube for manipulation thereof,
• (4) an overtube slideable along and receiving the inner tube,
• (5) a handle secured to a proximal end of the overtube for manipulation thereof, and
• (6) a shield attached to a distal end of the overtube longitudinally movable between a first position for receiving the fixation spikes in the inwardly bent configuration during peroral insertion into the esophagus, a second position for releasing the fixation spikes, and a third position for facilitating return of the fixation spikes to the memory position,
• comprising the steps of:
• threadably engaging the nipple in the annular body;
• bending the spikes inwardly and positioning the shield in the first position over the spikes;
• perorally inserting the valve prosthesis into the esophagus near the gastroesophageal junction;
• while holding the valve prosthesis in place, moving the shield into the second position to release the spikes to return to the memory position;
• optionally moving the shield into the third position to facilitate return of the spikes into the memory position to facilitate engagement of the spikes in a wall of the esophagus;
• rotating the inner tube with respect to the annular body to uncouple the nipple;
• and
• withdrawing the tool from the esophagus.