SYSTEMS AND METHODS FOR DETERMINING FAILURE OF INTRAGASTRIC DEVICES
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.
1 - 16 . (canceled)
17 . An intragastric balloon system, the system comprising:
a) an intragastric balloon; and
b) a device incorporated in the intragastric balloon, the device configured for alerting a patient or caregiver to a failure of the intragastric balloon, wherein the device is methylene blue.
18 . The intragastric balloon system of claim 17 , wherein the methylene blue is configured to be reduced to leukomethylene blue upon exposure to gastric fluids.
19 . The intragastric balloon system of claim 18 , wherein the methylene blue comprises 10 mg to 60 mg of methylene blue.
20 . The intragastric balloon system of claim 18 , wherein the methylene blue is in liquid form and is injected into the intragastric balloon.
21 . The intragastric balloon system of claim 18 , wherein the methylene blue is in a solution or suspension in a physiologically acceptable liquid.
22 . The intragastric balloon system of claim 17 , wherein the intragastric balloon comprises a wall defining a lumen, and a self-sealing valve.
23 . The intragastric balloon system of claim 22 , wherein the methylene blue has a weight of at least 10 mg.
24 . The intragastric balloon system of claim 22 , wherein the methylene blue is injected the balloon lumen in a liquid form.
25 . The intragastric balloon system of claim 22 , wherein the methylene blue is provided in a solid form.
26 . The intragastric balloon system of claim 25 , wherein the solid form is a paste, a pellet, granules, a powder, or encapsulated.
27 . The intragastric balloon system of claim 17 , wherein the failure is spontaneous deflation of the intragastric balloon.
28 . The intragastric balloon system of claim 17 , wherein the failure is leakage of a fill fluid contained within the intragastric balloon.
29 . A method for detecting a failure of an intragastric balloon, the method comprising:
introducing, into a stomach of a patient, an intragastric balloon comprising a device configured for alerting the patient or a caregiver to a failure of the intragastric balloon, wherein the device is a substance detectable in at least one of urine, feces, blood, perspiration, and breath;
introducing an initial fill fluid into a lumen of the intragastric balloon to inflate the intragastric balloon;
exposing the inflated intragastric balloon to the in vivo intragastric environment until a failure of the intragastric balloon occurs; and
detecting a failure of the intragastric balloon.
30 . The method of claim 29 , wherein the device comprises at least 10 mg of methylene blue, wherein the methylene blue is exposed to gastric fluids and is reduced to leukomethylene blue, and wherein detecting comprises observing a blue green color in the patient's urine upon excretion of leukomethylene blue.
31 . The method of claim 29 , wherein the failure is spontaneous deflation of the intragastric balloon or a leakage of a fill fluid contained within the intragastric balloon.
32 . The method of claim 29 , wherein the substance comprises at least one member of the group consisting of methylene blue, fast green FCF, indigo carmine, triamterene, senna glycosides, and betanin.
33 . The method of claim 29 , wherein the substance is injected the balloon lumen in a liquid form.
34 . The method of claim 29 , wherein the substance is provided in a solid form, wherein the solid form is a paste, a pellet, granules, a powder, or encapsulated.