Perorally removeable anti-reflux valve implantation

Abstract

Disclosed are esophageal anti-reflux valve prostheses, and tools and procedures for peroral implantation and extraction of the prostheses. The prostheses disclosed have a semipermeable membrane to allow retrograde passage of gas, magnets disposed at a distal end of the sleeve to facilitate closure, and an outwardly bendable array of spikes that are longitudinally aligned for peroral insertion and lockable into a radially outwardly deployed configuration to keep the prosthesis from dislocating after implantation. The implantation tool has inner and outer concentric tubes, the inner tube releasably threadably connected to the prosthesis, the outer tube reverse threaded with the inner tube to advance a distal headpiece to engage, deploy and lock the spikes into the deployed configuration. A vacuum assist can be used to help impact the lumen wall on the spikes. The extraction tool is similar to the implantation tool with an inner tube for threadably engaging the prosthesis, an outer tube with a distal crown with a plurality of shoes to unseat and unlock the spikes, and an overtube shield to receive the spikes and facilitate extraction of the prosthesis.

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       13 . 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.    
   
   
       14 . The method of  claim 13  wherein said valve is a sleeve valve.  
   
   
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       18 . The method of  claim 13  wherein each of the spikes include a tip at a free end thereof and a base attached to the annular body.  
   
   
       19 . The method of  claim 18  wherein a dog is formed between the base and the tip of each of the spikes.  
   
   
       20 . The method of  claim 19  wherein a plurality of keepers are positioned on an exterior surface of the annular body for receiving the dogs and locking the spikes in a deployed alignment.  
   
   
       21 . The method of  claim 13  wherein each of the spikes is outwardly bendable at the base between a retracted alignment during said postioning and a deployed alignment following said deployment.  
   
   
       22 . The method of  claim 21  wherein said retracted alignment is generally longitudinal.  
   
   
       23 . The method of  claim 21  wherein said deployed alignment is generally radially outward.  
   
   
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       26 . The method of  claim 14  wherein the annular body is internally threaded.  
   
   
       27 . The method of  claim 13  wherein the valve is implanted to relieve symptoms of a patient with Gastroesophageal reflux disease.  
   
   
       28 . The method of  claim 27  wherein the patient does not suffer from esophageal cancer.  
   
   
       29 . 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.    
   
   
       30 . The method of  claim 29  wherein the outer tube is configured to be advanced or retracted as the outer tube is rotated with respect to the inner tube.  
   
   
       31 . The method of  claim 30  said tool further comprising a handle, said handle being secured adjacent to a proximal end of the inner tube for manipulation thereof.  
   
   
       32 . The method of  claim 31  said tool further comprising a second handle secured adjacent to a proximal end of the outer tube to facilitate rotation of the outer tube with respect to the inner tube.  
   
   
       33 . The method of  claim 29  further comprising viewing the esophagus through a fiber optic cable disposed within a central longitudinal passage of the inner tube.  
   
   
       34 . The method of  claim 29  wherein the headpiece includes a plurality of transverse passages formed therein in communication with a transverse bore in a wall of the inner tube and a central longitudinal passage.  
   
   
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       36 . 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.    
   
   
       37 . The method of  claim 36  wherein the headpiece is configured to be removable and replaced with a crown, the crown configured to assist in the peroral removal of the prosthesis from the esophagus.  
   
   
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       39 . 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.    
   
   
       40 . The method of  claim 39  further comprising using a vacuum to assist in impaling the esophagus upon the spikes.  
   
   
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       58 . 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.  
   
   
   
       59 . The method of  claim 58  further comprising 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.  
   
   
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