Systems and methods for determining failure of intragastric devices
Inventors
Brister, Mark C. • Drake, Neil R. • Llevares, Antonio C. • Nelson, Sheldon • Proctor, Daniel J • Rasdal, Andrew P. • Sundseth, Keoni John • VandenBerg, Amy D.L. • Wong, Betty
Assignees
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Publication Number
US-11730619-B2
Publication Date
2023-08-22
Expiration Date
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.
Core Innovation
The invention relates to intragastric balloon systems that detect failure of an intragastric volume-occupying device in vivo. An intragastric balloon having a wall and a lumen includes a paste or solution of methylene blue dotted or printed onto at least a portion of an interior of the wall, and the methylene blue is configured to indicate a failure of the device.
In response to exposure to gastric fluids, the methylene blue is reduced to leukomethylene blue, yielding discolored urine as an indicator of failure. The disclosure includes failure-alert approaches using dyes and dye-containing forms that can be applied on the balloon interior, including solid forms and forms that can be protected by coatings, and also includes dissolvable or water-soluble coatings and encapsulated biomarkers.
The disclosure further describes intragastric balloon arrangements and failure detection concepts for spontaneous deflation and leakage of fill fluid. It also includes additional indicator output by combining methylene blue with a red emission dye to alter the urine discoloration, including blue-green urine discoloration and alternative outputs such as purple urine.
Claims Coverage
The claim coverage includes two independent claims covering an intragastric balloon device and a method of detecting failure, with two inventive features across the independent claims.
Methylene blue applied to balloon interior for urine discoloration failure indication
An intragastric balloon device comprising an intragastric balloon having a wall and a lumen, wherein a paste or solution of methylene blue is dotted or printed onto at least a portion of an interior of the wall and is configured to indicate a failure by being reduced to leukomethylene blue upon exposure to gastric fluids, so as to yield a discolored urine as an indicator of failure.
Introducing and inflating balloon to expose methylene blue to gastric fluids until failure
A method for detecting a failure of an intragastric volume-occupying device comprising introducing into a stomach a device with an intragastric balloon whose interior wall has a paste or solution of methylene blue dotted or printed onto at least a portion, introducing an initial fill fluid into the lumen to inflate the balloon, and exposing the inflated balloon to the in vivo intragastric environment until a failure of the intragastric balloon occurs, whereby methylene blue is exposed to gastric fluids and reduced to leukomethylene blue to yield discolored urine as an indicator of failure.
The independent claims cover an intragastric balloon device and a corresponding detection method in which methylene blue is applied to the balloon interior and, upon exposure to gastric fluids during balloon failure, is reduced to leukomethylene blue to produce discolored urine as the failure indicator.
Stated Advantages
Provides an indicator of failure of the intragastric volume-occupying device by producing discolored urine.
Yields discolored urine as an indicator of failure of the intragastric volume-occupying device.
Documented Applications
Detecting a failure of an intragastric volume-occupying device in vivo by yielding discolored urine as an indicator of failure.
Detecting a failure of an intragastric volume-occupying device in a patient by introducing the device into a stomach and observing discolored urine as an indicator of failure.
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