Methods And Devices For Anchoring A Gastroenterologic Sleeve

Abstract

A gastroenterologic sleeve is anchored within the digestive tract, without tissue-puncturing mechanisms, by providing anchoring mechanisms that utilize the inherent shape of the stomach to prevent sleeve migration. In at least two embodiments, the anchoring mechanism expands to conform to the interior stomach walls. In other embodiments, internal pessary rings are held in place at the gastroesophageal junction by an external band. A delivery device is provided for implanting the various device transesophageally.

What is claimed is: 
     
         1 . A device implantable in a digestive tract comprising a duodenum and a stomach having a body, an antrum, a pylorus and a pyloric sphincter, the device comprising:
 a sheath having a distal portion positionable within the duodenum and a proximal end configured to terminate within the pylorus when the device is positioned in the digestive tract, the sheath comprising a section extending between the distal portion and the proximal end, the section being configured to extend through the pyloric sphincter and to yield upon closure of the pyloric sphincter; and   an anchoring device configured to prevent migration of the sheath through the digestive tract without puncturing tissue of the digestive tract, the anchoring device comprising:
 a ring engaged with the proximal end of the sheath, the ring having an original configuration and being compressible to a collapsed configuration for delivery into the digestive tract, and converting to a sitting configuration once positioned within the digestive tract for sitting against a portion of the digestive tract uptract of the pyloric sphincter. 
   
     
     
         2 . The device of  claim 1 , wherein the sitting configuration corresponds to the original configuration. 
     
     
         3 . The device of  claim 1 , wherein the anchoring device further comprises:
 at least one additional ring provided in a spaced-apart relationship relative to the ring; and   a connecting mechanism connecting the ring and the at least one additional ring.   
     
     
         4 . The device of  claim 3 , wherein the sheath is engaged to a distalmost one of the ring and the at least one additional ring. 
     
     
         5 . The device of  claim 1 , wherein the anchoring device further comprises:
 a plurality of additional rings provided in a spaced-apart relationship relative to each other, at least one of the plurality of the additional rings being positionable within the antrum of the stomach; and   a connecting mechanism connecting the ring and the at least one additional ring;   
       wherein the sheath is engaged to a distalmost one of the ring and the at least one additional ring. 
     
     
         6 . The device of  claim 5 , wherein at least one of the plurality of the additional rings is positionable within the body of the stomach. 
     
     
         7 . The device of  claim 3 , wherein the connecting mechanism comprises a plurality of elongated connectors. 
     
     
         8 . The device of  claim 3 , wherein the connecting mechanism comprises a sleeve. 
     
     
         9 . The device of  claim 8 , wherein the sleeve is semi-permeable. 
     
     
         10 . The device of  claim 8 , wherein the anchoring device is configured to control an amount of food entering the stomach that is permitted to interact with the stomach. 
     
     
         11 . A method for reducing interaction between food and a digestive tract comprising a duodenum and a stomach having a body, an antrum, a pylorus and a pyloric sphincter, the method comprising:
 inserting a device comprising a sheath and an anchoring device into the digestive tract, the anchoring device comprising:
 a ring having an original configuration and being engaged with a proximal end of the sheath, the ring being configurable to a collapsed configuration for insertion within the digestive tract; 
   positioning a distal portion of the sheath within the duodenum and the ring in the pylorus such that a section of the sheath extends through the pyloric sphincter and the proximal end of the sheath terminates within the pylorus, wherein following the positioning, the ring is convertible to a sitting configuration for sitting against a portion of the digestive tract without puncturing tissue, and the section of the sheath is configured to yield upon closure of the pyloric sphincter.   
     
     
         12 . The method of  claim 11 , wherein the sitting configuration corresponds to the original configuration. 
     
     
         13 . The method of  claim 11 , wherein the device is insertable into the digestive tract via an endoscopic delivery device, and wherein the ring returns to its original configuration upon exiting the endoscopic delivery device. 
     
     
         14 . The method of  claim 13 , wherein the endoscopic delivery device comprises an endoscopic catheter and a sheath catheter surrounding the endoscopic catheter, the endoscopic catheter and the sheath catheter defining a tubular space therebetween to receive the ring when the ring is in the collapsed configuration. 
     
     
         15 . The method of  claim 14 , wherein the endoscopic catheter comprises a pulling wire and an attachment mechanism at a distal end thereof, and the device is engaged with the endoscopic delivery device via the attachment mechanism. 
     
     
         16 . The method of  claim 15 , further comprising retracting the pulling wire into the endoscopic catheter once the ring is deployed from the collapsed configuration to the original configuration. 
     
     
         17 . The method of  claim 11 , further comprising positioning an additional ring of the anchoring device within the stomach and in a spaced apart relationship relative to the ring positioned in the pylorus.