Injection of a therapeutic formulation into a wall of the gastrointestinal tract
Inventors
Assignees
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Publication Number
US-12642947-B2
Publication Date
2026-06-02
Expiration Date
Abstract
A device includes an inflatable balloon, a reservoir disposed within the inflatable balloon, a needle compartment attached to the balloon and to the reservoir, an injection needle disposed within the needle compartment, and an inflation mechanism. The reservoir contains a therapeutic preparation. The inflation mechanism is structured to inflate the balloon, and upon inflation, the injection needle is structured to enter the reservoir. A method includes making an autoinjector available to a subject with instructions to ingest the autoinjector. The autoinjector is structured to inject a therapeutic preparation into a wall of a gastrointestinal tract of the subject responsive to ingestion of the autoinjector. The autoinjector includes an injection needle disposed in a needle compartment attached to a reservoir. The injection needle is initially separated from the reservoir, and is structured to enter the reservoir for delivery of the fluid therapeutic preparation through the needle into the wall.
Core Innovation
The invention is directed to a swallowable autoinjector device that includes an inflatable balloon and a reservoir disposed within the inflatable balloon. The reservoir contains a fluid therapeutic preparation comprising a therapeutic agent, and the device further includes a needle compartment attached to the balloon and to the reservoir, with an injection needle disposed within the needle compartment.
The inflation mechanism inflates the balloon, and the injection needle is structured to enter the reservoir at a proximal end of the injection needle upon inflation of the balloon. The needle and reservoir arrangement enables fluid from the reservoir to be delivered through the needle for delivery into or through a gastrointestinal tract wall, with options described for delivery through multiple tissue layers and into a peritoneal cavity.
The device is implemented with additional structures for alignment and protection of the injection needle, including balloon/needle-compartment structures such as a degradable collar and a collapsible tube. Sealing features and optional balloon deflation via degradable valves are described, along with biodegradable materials for needle components and degrading elements associated with the needle compartment.
Claims Coverage
The independent claim is clm-00001 and defines one inventive feature set. Dependent claims introduce additional inventive features including post-expulsion balloon deflation, two-reactant inflation with gas formation, quantitative reservoir and therapeutic agent constraints, and needle-compartment structures with degradable materials.
Swallowable autoinjector with inflatable balloon reservoir and needle compartment
A swallowable autoinjector device comprising an inflatable balloon; a reservoir disposed within the inflatable balloon containing a fluid therapeutic preparation comprising a therapeutic agent; a needle compartment attached to the balloon and to the reservoir; and an injection needle disposed within the needle compartment.
Needle enters reservoir at proximal end upon balloon inflation
An inflation mechanism structured to inflate the balloon, wherein the injection needle is structured to enter the reservoir at a proximal end of the injection needle upon inflation of the balloon.
Deflation valve for post-expulsion balloon deflation
A deflation valve that deflates the balloon after the fluid therapeutic composition has been expelled from the reservoir.
Two-reactant inflation mechanism forming gas
An inflation mechanism with two reactants kept separate until the device is exposed to a fluidic environment, after which the selected reactants react to form gas that inflates the balloon.
Reservoir volume constraint
The reservoir is configured to hold up to 0.5 cubic centimeters of fluid.
Therapeutic agent payload constraint
The device is configured to contain up to 50 milligrams of a therapeutic agent.
Needle compartment with degradable collar and collapsible tube
A needle compartment with an upper chamber and lower chamber, where the upper chamber has a collar and a collapsible tube configured to protect and support an injection needle, and the collar is at least partially made of a material that degrades when exposed to a fluidic environment.
Overall claim coverage centers on a swallowable autoinjector where balloon inflation causes an injection needle to enter the reservoir at its proximal end for delivery of a fluid therapeutic preparation. Dependent coverage further refines the inflator architecture, adds optional post-delivery balloon deflation, constrains reservoir capacity and therapeutic agent amount, and specifies needle-compartment structures including degradable collar materials and needle protection support.
Stated Advantages
Documented Applications
No documented applications found
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