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Publication Number
US-11712356-B2
Publication Date
2023-08-01
Expiration Date
Abstract
A folded expandable gastro-retentive device and its uses in human medical care include, inter alia, appetite suppression in a subject in need thereof. The expanded device can be included in kits.
Core Innovation
Disclosed is a folded expandable gastro-retentive device having an initial folded form that is transformable, in sequence, upon delivery to a subject gastrointestinal system into an expanded 3-dimensional form, a declined form, and a disintegrated form. The device includes at least one compartment with an external enteric-biodegradable film that allows stomach liquid permeation therethrough, and the compartment encloses a film comprising at least one gel-forming compound.
The gel-forming compound is configured to undergo swelling into a gel upon contact with liquid in the stomach, thereby transforming the device into the expanded, 3-dimensional form. Upon continued stomach residence, the at least partial degradation of the gel-forming compound causes the device in the expanded form to adopt the declined form and evacuate through the pylorus into the intestine.
Finally, the external enteric biodegradable film is configured to enterically degrade in the intestine to transform the device to the disintegrated form. The disclosed device is orally administrable and is described for appetite/weight-loss use by maintaining a stomach residence period and then transitioning to evacuation and intestinal disintegration.
Claims Coverage
The independent claim specifies a single device architecture with sequential transformations into an expanded 3-dimensional form, a declined form, and a disintegrated form, driven by stomach-liquid permeation, gel swelling and degradation, and enteric film degradation. The main inventive features are distributed across the independent claim elements and refined by dependent claim constraints and material selections.
Folded to expanded to declined to disintegrated sequence
A folded expandable gastro-retentive device having an initial folded form transformable, in sequence, upon delivery to a subject gastrointestinal system into an expanded 3-dimensional form, a declined form, and a disintegrated form.
Enteric-biodegradable external film enabling stomach permeation
At least one compartment having an external enteric-biodegradable film that allows stomach liquid permeation therethrough, and a compartment enclosing a film comprising at least one gel-forming compound.
Gel swelling into an expanded 3-dimensional form in the stomach
The at least one gel-forming compound is configured to undergo swelling into a gel upon contact with liquid in the stomach to transform the device into the expanded, 3-dimensional form.
Partial degradation during stomach residence driving declined form and pylorus evacuation
Upon continued stomach residence, the at least partial degradation of the gel-forming compound causes the device in the expanded form to adopt the declined form and evacuate through the pylorus into the intestine.
Intestinal enteric degradation producing disintegrated form
The external enteric biodegradable film is configured to enterically degrade in the intestine to transform the device to the disintegrated form.
Overall claim coverage centers on a folded expandable gastro-retentive device that transforms in sequence from expanded 3-dimensional form to declined form via stomach-liquid permeation, gel swelling and partial degradation, and then to a disintegrated form via enteric-biodegradable film degradation in the intestine.
Stated Advantages
Maintains stomach residence before adopting a declined form and evacuating through the pylorus.
Transforms to an expanded 3-dimensional form and then to a disintegrated form via degradation in the intestine.
Used for appetite/weight-loss by stimulating stomach fullness/satiety and appetite suppression.
Documented Applications
Oral appetite/weight-loss use, including appetite suppression/weight loss by stimulating stomach fullness/satiety and gastro-retentive residence.
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