Implantable weight control device

Abstract

The present invention provides an endoscopically implantable weight control device that forms a gastric outlet obstruction in a patient's digestive tract. The weight control device includes an inflatable body residing within the patient's pylorus and between the stomach and duodenum. The body features a first bulbous portion and a second bulbous portion, the exterior dimensions of the first bulbous portion exceeding the exterior dimension of the second bulbous portion. The body also includes an intermediate portion with exterior dimensions that are less than the exterior dimensions of both the first and second bulbous portions, wherein the intermediate portion resides within the patient's pyloric valve when the device is implanted. An internal passageway extends through the body, wherein the passageway receives and allows for the passage of chyme from the stomach to the duodenum. A method of treating obese patients with the inflatable weight control device utilizing a sequence of different-sized devices is also provided.

What is claimed is: 
     
         1 . An endoscopically implantable weight control device that forms a gastric outlet obstruction in a patient's digestive tract, the weight control device comprising:
 an inflatable body residing between the patient's stomach and duodenum, the body having:
 a first bulbous potion; 
 a second bulbous portion, the exterior dimensions of the first bulbous portion exceeding the exterior dimension of the second bulbous portion; 
 an intermediate portion with exterior dimensions less than the exterior dimensions of both the first and second bulbous portions, wherein the intermediate portion resides within the patient's pyloric valve when the device is implanted; and, 
 an internal passageway extending through the body, wherein the passageway receives and allows far the passage of chyme from the stomach to the duodenum. 
   
     
     
         2 . The implantable weight control device of  claim 1 , wherein an exterior surface of the first bulbous portion engages an inner surface of the pyloric antrum. 
     
     
         3 . The implantable weight control device of  claim 1 , wherein an exterior surface of the intermediate portion engages an inner surface of the pyloric valve. 
     
     
         4 . The implantable weight control device of  claim 1 , wherein an exterior surface of the second bulbous portion engages an inner surface of the pyloric canal. 
     
     
         5 . The implantable weight control device of  claim 1 , wherein the transition from the first bulbous portion to the intermediate portion defines a first interface region that engages the terminal portion of the stomach prior to the pyloric valve. 
     
     
         6 . The implantable weight control device of  claim 1 , wherein the first bulbous portion includes a valve assembly that allows for the filling of the inflatable body. 
     
     
         7 . The implantable weight control device of  claim 6 , wherein the valve assembly includes a stem that is grasped by an endoscope during implantation of the device. 
     
     
         8 . The implantable weight control device of  claim 1 , wherein the internal passageway extends from an end wall of the first bulbous portion through the intermediate potion and to an end wall of the second bulbous portion. 
     
     
         9 . A weight control device that is implantable with an endoscope and that forms a gastric outlet obstruction in a patient's digestive tract, the weight control device comprising:
 an inflatable body having a first bulb, a second bulb with a circumference less than a circumference of the first bulb, and an intermediate portion, wherein the intermediate portion resides within the patient's pyloric valve when the device is implanted;   the body further having at least one internal passageway extending through the first and second bulbs; and,   wherein chyme exiting the patient's stomach passes through the internal passageway to reach the duodenum.   
     
     
         10 . The weight control device of  claim 9 , wherein the first bulb defines an obstruction that prevents chyme, other than that passing through the internal passageway, from reaching the pyloric valve and the duodenum. 
     
     
         11 . The weight control device of  claim 9 , wherein first bulb engages an inner surface of the stomach proximate the pyloric valve to prevent the firs bulb from moving past the pyloric valve and into the duodenum. 
     
     
         12 . The weight control device of  claim 11 , wherein the intermediate portion engages an inner surface of the pyloric valve. 
     
     
         13 . The weight control device of  claim 11 , wherein the second bulb engages an inner surface of the pyloric canal proximate the pyloric valve. 
     
     
         14 . The weight control device of  claim 9 , wherein the body has a dumbbell configuration, wherein the transition from the first bulb to the intermediate portion defines a first annular shoulder that engages the terminal portion of the stomach prior to the pyloric valve. 
     
     
         15 . The weight control device of  claim 9 , wherein the first bulb includes a stem assembly that is grasped by an endoscope during implantation of the device, wherein the stem assembly includes a valve for filling of the inflatable body. 
     
     
         16 . The weight control device of  claim 9 , wherein the internal passageway extends from an end wall of the first bulb through the intermediate portion and to an end wall of the second bulb. 
     
     
         17 . The weight control device of  claim 9 , further comprising a first insert that is removably inserted within the internal passageway, the first insert having a diameter that is less than a diameter of the internal passageway. 
     
     
         18 . The weight control device of  claim 17 , further comprising a second insert that is removably inserted within the internal passageway, the second insert having a diameter that is less than the diameter of both the first insert and the internal passageway. 
     
     
         19 . An endoscopically implantable weight control device that forms a gastric outlet obstruction in a patient's digestive tract, the weight control device comprising:
 an inflatable body having a first bulb, a second bulb, and an intermediate portion that resides within the patient's pyloric valve;   the inflatable body further having at least one internal passageway extending between an end wall of the first bulb through the intermediate portion and to an end wall of the second bulb, wherein the passageway receives and allows for the passage of chyme from the stomach to the duodenum.   
     
     
         20 . The weight control device of  claim 19 , wherein the weight control device is implanted with an endoscope in the patient's digestive tract in a deflated state, and then inflated such that the first bulb engages an inner surface of the stomach proximate the pyloric valve and the intermediate portion engages an inner surface of the pyloric channel. 
     
     
         21 . The weight control device of  claim 19 , further comprising:
 a first insert that is removably inserted within the internal passageway, the first insert having a diameter that is less than a diameter of the internal passageway; and,   a second insert that is removably inserted within the internal passageway, the second insert having a diameter that is less than the diameter of both the first insert and the internal passageway.   
     
     
         22 . The weight control device of  claim 19 , wherein the inflatable body has a pair of internal passageways extending from the end wall of the first bulb through the intermediate portion and to the end wall of the second bulb, wherein the passageways receive chyme from the stomach to the duodenum.