Systems and methods for determining failure of intragastric devices

Abstract

Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, locating, tracking, monitoring, deflating, and retrieving the same are provided.

What is claimed is: 
     
         1 . An intragastric volume-occupying device, comprising:
 an intragastric balloon having a wall and a lumen; and   methylene blue in a solid form contained within the lumen of the intragastric balloon, wherein the methylene blue is configured to indicate a failure of the intragastric volume-occupying device by being reduced to leukomethylene blue upon exposure to gastric fluids, so as to yield a discolored urine as an indicator of failure of the intragastric volume-occupying device.   
     
     
         2 . The intragastric volume-occupying device of  claim 1 , wherein the failure is a spontaneous deflation of the intragastric balloon. 
     
     
         3 . The intragastric volume-occupying device of  claim 1 , wherein the failure is a leakage of a fill fluid contained within the intragastric balloon. 
     
     
         4 . The intragastric volume-occupying device of  claim 1 , wherein the fill fluid is SF 6 . 
     
     
         5 . The intragastric volume-occupying device of  claim 1 , wherein the fill fluid is a combination of nitrogen and SF 6 . 
     
     
         6 . The intragastric volume-occupying device of  claim 1 , wherein the solid form is selected from the group consisting of a paste, a pellet, granules, powder, and an encapsulated form. 
     
     
         7 . The intragastric volume-occupying device of  claim 1 , wherein the methylene blue is in a pure state. 
     
     
         8 . The intragastric volume-occupying device of  claim 1 , wherein the methylene blue is in combination with a pharmaceutically acceptable excipient. 
     
     
         9 . The intragastric volume-occupying device of  claim 1 , wherein the device comprises 10 mg to 60 mg of methylene blue. 
     
     
         10 . The intragastric volume-occupying device of  claim 1 , further comprising a red emission dye in combination with the methylene blue, wherein the combination is contained within the lumen of the intragastric balloon, and wherein the combination is configured to indicate a failure of the intragastric volume-occupying device upon exposure to gastric fluids, so as to yield a purple urine as an indicator of failure of the intragastric volume-occupying device. 
     
     
         11 . The intragastric volume-occupying device of  claim 10 , wherein the red emission dye is betalain. 
     
     
         12 . A method for detecting a failure of an intragastric volume-occupying device, the method comprising:
 introducing, into a stomach of a patient, an intragastric volume-occupying device comprising an intragastric balloon and methylene blue in a solid form, wherein the intragastric balloon has a wall and a lumen, and wherein the methylene blue is contained within the lumen of the intragastric balloon;   introducing an initial fill fluid into the lumen of the intragastric balloon to inflate the intragastric balloon; and   exposing the inflated intragastric balloon to the in vivo intragastric environment until a failure of the intragastric balloon occurs, whereby the methylene blue is exposed to gastric fluids and is reduced to leukomethylene blue, so as to yield a discolored urine as an indicator of failure of the intragastric volume-occupying device.   
     
     
         13 . The method of  claim 12 , wherein the failure is a spontaneous deflation of the intragastric balloon or a leakage of the fill fluid contained within the intragastric balloon. 
     
     
         14 . The method of  claim 12 , wherein the fill fluid is SF 6 . 
     
     
         15 . The method of  claim 12 , wherein the fill fluid is a combination of nitrogen and SF 6 . 
     
     
         16 . The method of  claim 12 , wherein the solid form is selected from the group consisting of a paste, a pellet, granules, powder, and an encapsulated form. 
     
     
         17 . The method of  claim 12 , wherein the methylene blue is in a pure state. 
     
     
         18 . The method of  claim 12 , wherein the methylene blue is in combination with a pharmaceutically acceptable excipient. 
     
     
         19 . The method of  claim 12 , wherein the methylene blue is present in a combination with a red emission dye, wherein the combination is configured to indicate a failure of the intragastric volume-occupying device upon exposure to gastric fluids, so as to yield a purple urine as an indicator of failure of the intragastric volume-occupying device. 
     
     
         20 . The method of  claim 12 , wherein the device comprises 10 mg to 60 mg of methylene blue.