Satiation pouches and methods of use

Abstract

A pouch positionable within the gastro-esophageal region of a patient, such as for use as a satiation device, is described herein. The pouch includes a proximal opening and an exit port, and is positionable such that food ingested by the patient passes into the interior of the pouch and subsequently out the exit port. A barrier on the proximal portion of the pouch contacts surrounding tissue and thereby minimizes passage of food from the esophagus around the exterior of the pouch—thereby substantially preventing food from bypassing the pouch. In preferred forms of the embodiment, the barrier is adaptable in response to movement of the surrounding tissue to maintain contact between the barrier and the surrounding tissue.

We claim:  
     
         1 . A method of positioning a prosthetic device within a patient having an esophagus, a stomach, and a gastro-esophageal junction region, the method comprising the steps of: 
 providing a prosthetic device having a proximal opening and an exit port, and a barrier on a proximal portion of the prosthetic device, the barrier having a central passage at least partially aligned with the proximal opening;    securing the prosthetic device within a patient by attaching the prosthetic device to tissue of the gastro-esophageal region of the patient, the prosthetic device oriented such that food ingested by the patient passes from the esophagus through the central passage and proximal opening into the interior of the prosthetic device; and    causing the barrier device to contact surrounding tissue, the barrier minimizing passage of food from the esophagus around the exterior of the prosthetic device and into the stomach.    
     
     
         2 . The method of  claim 1 , wherein the barrier includes flexible webbing defining the central passage.  
     
     
         3 . The method of  claim 2 , wherein the flexible webbing includes a resilient spring structure, and wherein the causing step includes allowing the spring structure to move radially outwardly, carrying the webbing into contact with the surrounding tissue.  
     
     
         4 . The method of  claim 1 , wherein the barrier includes a plurality of spring members defining the central passage and spring biased in a radially outward direction, and wherein the causing step includes allowing the blade members to move radially outwardly into contact with the surrounding tissue.  
     
     
         5 . The method of  claim 1 , wherein the barrier includes a stent structure spring biased in a radially outward direction, and wherein the causing step includes allowing the stent structure to move radially outwardly into contact with the surrounding tissue.  
     
     
         6 . The method of  claim 1 , wherein the barrier includes a conformable material, and wherein the causing step includes positioning the conformable material into contact with surrounding tissue.  
     
     
         7 . The method of  claim 6 , wherein the conformable material includes an inflatable bladder.  
     
     
         8 . The method of  claim 7 , wherein the causing step includes inflating the bladder into contact with the surrounding tissue.  
     
     
         9 . The method of  claim 7 , wherein the causing step includes inflating the bladder and then positioning the bladder into contact with the surrounding tissue.  
     
     
         10 . The method of  claim 6 , wherein the conformable material is a foam material.  
     
     
         11 . The method of  claim 1 , wherein the barrier includes a proximal rim formed on the prosthetic device, the rim having an inverted position extending within the prosthetic device and a non-inverted position, wherein 
 the securing step includes, with the rim in the inverted position, connecting a portion of the rim to the tissue; and    the causing step includes moving the rim to the non-inverted position.    
     
     
         12 . The method of  claim 1 , wherein the method includes causing the barrier to maintain contact with the surrounding tissue during movement of the stomach or expansion of the prosthetic device.  
     
     
         13 . The method of  claim 1 , wherein the prosthetic device is a satiation pouch, and wherein the proximal opening is larger than the exit port.  
     
     
         14 . A medical device positionable within a gastro-esophageal junction region of a patient having an esophagus and a stomach, the medical device comprising: 
 a prosthetic device having a proximal opening and an exit port, a proximal portion of the prosthetic device positionable within the gastro-esophageal junction region such that the proximal opening is in substantial alignment with the esophagus; and    a barrier attached to a proximal portion of the prosthetic device, the barrier defining a central passage at least partially aligned with the proximal opening of the prosthetic device, the barrier positioned to contact surrounding tissue substantially around its circumference when the prosthetic device is positioned within the gastro-esophageal junction region and to substantially maintain said contact despite movement of the surrounding tissue.    
     
     
         15 . The medical device of  claim 14 , wherein the barrier includes a wall of flexible webbing.  
     
     
         16 . The medical device of  claim 15 , wherein the wall further includes a resilient spring structure connected to the flexible webbing.  
     
     
         17 . The medical device of  claim 14 , wherein the barrier includes a plurality of spring members defining the central passage and spring biased in a radially outward direction.  
     
     
         18 . The medical device of  claim 14 , wherein the barrier includes a stent structure spring biased in a radially outward direction.  
     
     
         19 . The medical device of  claim 14 , wherein the barrier is a conformable structure.  
     
     
         20 . The medical device of  claim 19 , wherein the conformable structure is an inflatable bladder.  
     
     
         21 . The medical device of  claim 19 , wherein the conformable structure includes foam material.  
     
     
         22 . The medical device of  claim 14 , wherein the barrier includes a proximal rim formed on the prosthetic device and anchors attached to the rim, the rim moveable between an inverted position in which the rim extends within the interior of the prosthetic device and in which the anchors are in first position, and a non-inverted position in which the rim is removed from the interior of the proximal device and in which the anchors are in a second position, the second position being more distal than the first position.  
     
     
         23 . The medical device of  claim 14 , wherein the barrier is adaptable in response to movement of the surrounding tissue to maintain said contact between the barrier and the surrounding tissue.  
     
     
         24 . A method of treating obesity in a patient having an esophagus, a stomach, and a gastro-esophageal junction region, the method comprising the steps of: 
 providing a pouch having a proximal opening and an exit port, the exit port being smaller than the proximal opening;    further providing a barrier having a central passage at least partially aligned with the proximal opening;    attaching the pouch to tissue of the gastro-esophageal region of the patient and causing the barrier device to contact tissue substantially around its circumference;    causing the patient to ingest food, the ingested food passing from the esophagus through the central passage and proximal opening into the interior of the pouch, the barrier minimizing passage of food from the esophagus around the exterior of the pouch.    
     
     
         25 . The method of  claim 24 , wherein the barrier includes flexible webbing defining the central passage.  
     
     
         26 . The method of  claim 25 , wherein the flexible webbing includes a resilient spring structure, and wherein the causing step includes allowing the spring structure to move radially outwardly, carrying the webbing into contact with the surrounding tissue.  
     
     
         27 . The method of  claim 24 , wherein the barrier includes a plurality of spring members defining the central passage and spring biased in a radially outward direction, and wherein the attaching step includes allowing the blade members to move radially outwardly into contact with the surrounding tissue.  
     
     
         28 . The method of  claim 24 , wherein the barrier includes a stent structure spring biased in a radially outward direction, and wherein the attaching step includes allowing the stent structure to move radially outwardly into contact with the surrounding tissue.  
     
     
         29 . The method of  claim 24 , wherein the barrier includes a conformable material, and wherein the attaching step includes positioning the conformable material into contact with surrounding tissue.  
     
     
         30 . The method of  claim 29 , wherein the conformable material includes an inflatable bladder.  
     
     
         31 . The method of  claim 30 , wherein the attaching step includes inflating the bladder into contact with the surrounding tissue.  
     
     
         32 . The method of  claim 30 , wherein the attaching step includes inflating the bladder and then positioning the bladder into contact with the surrounding tissue.  
     
     
         33 . The method of  claim 29 , wherein the conformable material is a foam material.  
     
     
         34 . The method of  claim 24 , wherein the barrier includes a proximal rim formed on the prosthetic device, the rim having an inverted position extending within the prosthetic device and a non-inverted position, wherein: 
 the attaching step includes, with the rim in the inverted position, connecting a portion of the rim to the tissue, and then moving the rim to the non-inverted position.    
     
     
         35 . The method of  claim 24 , wherein the method includes causing the barrier to maintain contact with the surrounding tissue during movement of the stomach or expansion of the pouch.  
     
     
         36 . A method of positioning a prosthetic device in a body cavity region defined by a circumferential wall, comprising the steps of: 
 providing a prosthetic device having a proximal opening and a distal opening, a passage extending between the proximal and distal openings, and a barrier on a proximal portion of the prosthetic device;    distending a circumferential wall of a body cavity region;    positioning the prosthetic device adjacent to the disentended circumferential wall; and    releasing the circumferential wall from the distended positioning, allowing the released wall to circumferentially contact the barrier, the barrier encouraging passage of substances through the passage by minimizing passage of body fluid around an exterior of the prosthetic device.    
     
     
         37 . The method of  claim 36 , wherein the circumferential wall is flared from a proximal portion to a distal portion.  
     
     
         38 . The method of  claim 36 , further comprising the step of attaching the prosthetic device to the circumferential wall using an attachment device.  
     
     
         39 . The method of  claim 37 , wherein the circumferential wall is a wall of a proximal stomach, and wherein the barrier encourages passage of ingested food from an esophagus through the passage of the prosthetic device.  
     
     
         40 . A method of positioning a prosthetic device in a body cavity region defined by a flared circumferential wall, comprising the steps of: 
 providing a prosthetic device having a proximal opening and a distal opening, a passage extending between the proximal and distal openings, and a barrier on a proximal portion of the prosthetic device;    positioning the barrier in a collapsed position;    positioning the prosthetic device with the barrier adjacent to the flared circumferential wall; and    releasing the barrier from the collapsed positioning, allowing the released barrier to circumferentially contact the flared circumferential wall, the barrier encouraging passage of substances through the passage by minimizing passage of body fluid around an exterior of the prosthetic device.    
     
     
         41 . The method of  claim 40 , further comprising the step of attaching the prosthetic device to the circumferential wall using an attachment device.  
     
     
         42 . The method of  claim 40 , wherein the circumferential wall is a wall of a proximal stomach, and wherein the barrier encourages passage of ingested food from an esophagus through the passage of the prosthetic device.