Intragastric device
Inventors
Brister, Mark C. • Quintana, Nelson • Patel, Kaushik A. • Drake, Neil R. • Llevares, Antonio C. • Markovic, Dubravka • Rasdal, Andrew P. • VandenBerg, Amy D. L.
Assignees
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Publication Number
US-12090075-B2
Publication Date
2024-09-17
Expiration Date
Abstract
An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient's stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state. In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity. After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient's digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.
Core Innovation
The invention describes an orally ingestible, free-floating intragastric volume-occupying device for obesity that is swallowed in a compact delivery state and inflates to an expanded satiety-inducing state. The system is configured for time-dependent or on-demand inflation and deflation to manage balloon deployment and ensure eventual passage through the gastrointestinal tract.
The swallowable intragastric balloon system utilizes a self-sealing valve system comprising a septum, a retaining structure, and a continuous ring attached by an adhesive with a shear force greater than approximately 40 N. The device includes an inner container with an inflation agent and a timing-controlled outer container that facilitates swallowing without assistance in a compacted state.
Deflation is achieved through subcomponents configured for forced de-lamination using a composite of a strong first layer, an erodible middle layer, and a weak inner layer affected by the gastric environment. Alternatively, on-demand deflation is provided by a pneumatic valve that releases fluid to change internal pressure, and the system may incorporate tracking, visualization, or pharmaceutical delivery components.
Claims Coverage
The independent claims cover three main inventive feature sets for a swallowable, intragastric balloon system focused on controlled valve integrity and specific deflation mechanisms.
Self-sealing valve with adhesive-bonded septum, retaining structure, and continuous ring plus timing-controlled compact outer container
A swallowable, intragastric balloon system comprising a balloon with a self-sealing valve system attached to a wall in a central lumen by an adhesive with a shear force greater than about 40 N, where the self-sealing valve system comprises a septum, a retaining structure, and a continuous ring; an inner container within the central lumen containing about 0.28 grams to about 4 grams of an inflation agent; and an outer container configured to be swallowed by a patient without assistance, where the outer container comprises a material and a structure configured to control timing of inflation and contains the inner container and the balloon in a compacted state.
Forced de-lamination scheme using strong, erodible, and weak layers affected by gastric environment for time-dependent deflation
A swallowable, intragastric balloon system comprising an ingestible capsule formed of a material having a known rate of degradation; and a balloon with one or more deflation subcomponents configured for time-dependent deflation, where a forced de-lamination scheme is created for time-dependent deflation, and where the one or more deflation subcomponents comprise a strong first layer, an erodible middle layer, and a weak inner layer affected by a gastric environment.
On-demand pneumatic valve deflation via opening and releasing fluid to change internal pressure
A swallowable, intragastric balloon system comprising an ingestible capsule formed of a material having a known rate of degradation; and a balloon with one or more deflation subcomponents configured for on-demand deflation, where the one or more deflation subcomponents comprise a pneumatic valve in the balloon to change the internal pressure by opening and releasing fluid inside and deflating the balloon.
Overall, the claims target systems that achieve controlled inflation timing via an outer container and specific deflation outcomes through either forced de-lamination of layered subcomponents or pneumatic valve pressure release.
Stated Advantages
Provides a satiety-inducing expanded state within the stomach for obesity treatment.
Inflates to an expanded state and later deflates so the device can pass through the GI tract.
Enables inflation/deflation that can be time-dependent or on-demand.
Enables timing of inflation in a compacted state and controlled self-deflation timing windows.
Documented Applications
Treatment of obesity using an orally ingestible, free-floating intragastric volume-occupying device that induces satiety.
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