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Publication Number
US-10507127-B2
Publication Date
2019-12-17
Expiration Date
Abstract
This invention relates to an expanded device and its uses in human medical care, which include, inter alia, appetite suppression in a subject in need thereof and kits comprising thereof.
Core Innovation
The invention provides an orally deliverable folded device encased in a gastric degradable swallowable encasing. The folded device comprises at least one compartment defined by a space enclosed by walls formed by an external enterically biodegradable film, and the external enterically biodegradable film encloses a gel-film comprising particles of at least one gel-forming compound.
Upon delivery to a stomach, the folded device transforms into an unfolded expanded form as the encasing degrades. During this transformation, the particles in the gel-film undergo swelling with a swelling ratio of about 10 to about 100 times-fold, and the external enterically biodegradable film disintegrates after the device leaves the stomach.
The disclosure additionally characterizes expandable intra-gastric use for appetite suppression and weight loss via gastric exposure and an unfolded expanded structure. It also describes compartment configurations connected into varied structures and material-property constraints for the biodegradable film and the gel system, including swelling behavior and mechanical properties such as tensile strength and elasticity.
Claims Coverage
The partial content includes one independent claim directed to a folded, gastric-degradable swallowable encased device that transforms into an unfolded expanded form with swelling of gel-film particles, along with dependent claim refinements covering gel composition, film properties, residence time, multi-compartment structure, and three-dimensional configurations.
Folded device in gastric degradable swallowable encasing with enterically biodegradable film compartment walls
A folded device encased in a gastric degradable swallowable encasing, the folded device comprising at least one compartment defined by a space enclosed by walls formed by an external enterically biodegradable film, and the external enterically biodegradable film enclosing a gel-film comprising particles of at least one gel-forming compound.
Unfolding and swelling-driven expanded form in the stomach with post-stomach film disintegration
Upon delivery to a stomach of a subject, the folded device is transformable into an unfolded expanded form as the encasing degrades and the particles comprised in said gel-film undergo swelling with a swelling ratio of about 10 to about 100 times-fold, wherein the biodegradable film disintegrates after the device leaves the stomach.
Specified gel-film thickness for swelling expansion
The gel-film has a thickness of between about 50 and about 300 microns, or a thickness of about 400, about 500, about 600, about 700, or about 800 microns.
Charged gel-forming compounds including charged super absorbent polymer and opposite-charge component
The device includes gel-forming compounds comprising a charged superabsorbent polymer and another compound bearing an opposite charge to the charged gel-forming compound.
External enterically biodegradable film mechanical properties under dry and wet conditions
The device includes an external enterically biodegradable film having specified tensile strength ranges under dry and wet conditions.
Stomach residence time for the compartment
At least one compartment is configured to remain in a stomach for about 0.5 hrs to about 30 days.
Interconnected multiple compartments with external enterically biodegradable films
A device variant where multiple interconnected compartments each include an independently applied external enterically biodegradable film and contain gel forming compounds, all enclosed within a gastric degradable swallowable encasing.
Three-dimensional shape formed by interconnected compartments
Connected compartments together form a 3D shape chosen from linear shapes, polygons, rings, or combinations thereof.
Coverage centers on a folded device in a gastric degradable swallowable encasing that unfolds to an expanded form in the stomach as the encasing degrades, with gel-film particles swelling by a specified 10–100 times-fold ratio and the external enterically biodegradable film disintegrating after leaving the stomach. Additional refinements specify gel-film thickness, charged gel-forming chemistry, tensile properties of the external enterically biodegradable film, stomach residence time, multi-compartment interconnected structures, and 3D geometric configurations.
Stated Advantages
Appetite suppression.
Weight loss.
Documented Applications
Expandable intra-gastric device for appetite suppression and weight loss, used by oral delivery into the stomach where it expands during residence and transforms as gastric degradation occurs.
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