Low volume intragastric device

Abstract

The teachings are directed to an intragastric device comprising a flexible and expandable bladder having a predetermined shape upon expansion for contacting the antrum of the stomach of a subject. The device is designed to avoid passage of any part of the device beyond the pylorus and lower esophageal sphincter while the bladder is expanded during use. In these embodiments, the bladder can contain a high specific gravity material when expanded; wherein, the high specific gravity material contributes to an in vivo specific gravity of the device that ranges from about 1.2 g/ml to about 2.1 g/ml and functions to direct the device to the pyloric antrum of the subject during use of the device. Moreover, these embodiments can include a filling material comprising a biocompatible fluid component and a hydrogel component to make the device substantially leakproof and contribute to the in vivo specific gravity of the device.

We claim: 
     
         1 . An untethered, low volume intragastric device, comprising:
 a single expandable casing having
 a minimum, cross-sectional dimension of at least about 40 mm when expanded in the subject; and, 
 a maximum, cross-sectional dimension of at least about 70 mm when expanded in the subject; 
   and,   an in vivo specific gravity of the device in the subject that ranges from about 1.2 to about 2.1 during operation.   
     
     
         2 . The device of  claim 1 , wherein the casing comprises the high specific gravity material. 
     
     
         3 . The device of  claim 1 , wherein the outer surface of the casing comprises the high specific gravity material. 
     
     
         4 . The device of  claim 1 , wherein the casing encloses an inner compartment and has a sealable port in communication with the inner compartment for administering a fluid and expanding the casing in the stomach of a subject. 
     
     
         5 . The device of  claim 4 , wherein the inner compartment contains the high specific gravity material. 
     
     
         6 . The device of  claim 4 , wherein the inner compartment contains the high specific gravity material, and the high specific gravity material is integrated with the casing. 
     
     
         7 . The device of  claim 1 , wherein the high specific gravity material comprises a biocompatible fluid. 
     
     
         8 . The device of  claim 1 , wherein the high specific gravity material comprises a biocompatible fluid selected from the group consisting of a salt solution, a sugar solution, honey, a sugar alcohol solution, glycerin, or a combination thereof. 
     
     
         9 . The device of  claim 1 , wherein the high specific gravity material comprises a sugar alcohol solution. 
     
     
         10 . The device of  claim 1 , wherein the high specific gravity material comprises a solid component. 
     
     
         11 . The device of  claim 1 , wherein the high specific gravity material comprises a hydrogel. 
     
     
         12 . The device of  claim 1 , wherein the high specific gravity material comprises a biocompatible solid selected from the group consisting of a metal, a salt, a heavy polymer or a combination thereof. 
     
     
         13 . The device of  claim 1 , wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.5. 
     
     
         14 . The device of  claim 1 , wherein the device has an in vivo specific gravity ranging from about 1.2 to about 1.3. 
     
     
         15 . The device of  claim 1 , wherein the device has an in vivo specific gravity ranging from about 1.3 to about 1.6. 
     
     
         16 . The device of  claim 1 , wherein, the device has a spherical shape during operation of the device in the subject. 
     
     
         17 . A method of administering the device of  claim 1 , comprising:
 placing the device in a collapsed state in the stomach of the subject; and,   expanding the device after the placing; wherein,   the high specific gravity functions to direct the device to the antrum of the stomach.   
     
     
         18 . A method of treating obesity in a subject using the device of  claim 1 , wherein the method comprises:
 placing the device in a collapsed state in the stomach of the subject;   expanding the device; and,   treating the subject for an effective amount of time.   
     
     
         19 . The method of  claim 19 , wherein, the treating includes a deployment period of at least 9 months. 
     
     
         20 . A kit comprising the device of  claim 1 , a filling material having a specific gravity of greater than 1.2, and an insertion catheter designed for administration of the device in the subject.