Ingestible GI Device Pivoting Arm for Lumen Wall Delivery
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Solution Overview
Problem
Current methods for delivering therapeutic agents into the gastrointestinal (GI) tract face challenges such as enzymatic breakdown in the GI tract, poor tolerance leading to low systemic uptake, and patient discomfort from parenteral injections.
Innovation Solution
An ingestible device comprising an enclosure, support, arm, delivery assembly, extender, actuator, and release mechanism, designed to deliver therapeutic preparations directly into the GI lumen wall or surrounding tissue, overcoming enzymatic breakdown and improving systemic uptake.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If therapeutic agents are administered by ingestion, then patient comfort is improved, but enzymatic breakdown in the GI tract reduces therapeutic efficacy
Solution Approach 1:
The device segments the therapeutic journey into distinct phases: oral ingestion of the capsule, transit through the GI tract, localized deployment at the target site, and controlled release into the lumen wall. This segmentation allows the therapeutic agent to avoid enzymatic breakdown by delivering it directly to the target tissue rather than allowing it to traverse the entire GI tract in solution form.
Solution Approach 2:
The ingestible device acts as an intermediary carrier that protects the therapeutic agent from enzymatic degradation in the GI tract. The device includes protective components (enclosure, delivery assembly) that shield the therapeutic preparation until it reaches the target site, where controlled release occurs directly into the lumen wall, bypassing the harmful enzymatic environment.
2Reliability
If therapeutic agents are administered by parenteral injection, then therapeutic efficacy is improved, but patient discomfort and inconvenience increase
Solution Approach 1:
The device enables self-service administration where patients can self-administer the therapeutic agent orally at home without requiring healthcare professional intervention for injection. The automated deployment mechanism (actuator, release mechanism) performs the complex delivery function automatically after ingestion, eliminating the need for painful injections while maintaining effective delivery.
3Manufacturing precision
If the device extends the delivery assembly outwardly to reach the lumen wall, then delivery precision is improved, but device complexity increases
Solution Approach 1:
The delivery assembly transitions from a static retracted state during ingestion and transit to a dynamic extended state when reaching the target site. The actuator mechanism enables controlled extension and retraction, allowing the delivery structure to reach the lumen wall with precision only when needed, while maintaining a compact form during other phases of the journey.
Solution Approach 2:
The delivery assembly is nested within the enclosure during ingestion and transit, with the extender collapsed within the support structure. When activation occurs, the nested components unfold and extend in a controlled sequence, allowing precise positioning of the delivery structure at the lumen wall while maintaining a compact, ingestible size during the journey through the GI tract.
Data Source
AI summary
An ingestible device for delivering a therapeutic preparation into a lumen wall or a surrounding tissue of a gastrointestinal (GI) tract of a subject includes an enclosure, a support, an arm, a delivery assembly, an extender, an actuator, and a release. The support is disposed in the enclosure and defines a longitudinal axis of the device. The delivery assembly includes a delivery structure coupled to the arm, and a therapeutic preparation disposed in the delivery structure. The extender is coupled to at least one of the support or the delivery assembly. The extender is structured to extend along the longitudinal axis to substantially align the delivery structure relative to the lumen wall. The actuator is coupled to the delivery assembly. The release is coupled to the actuator and is activated in response to a condition in the GI tract to cause actuation of the actuator. When the release is activated, the actuator causes the arm to pivot relative to the support such that the delivery assembly extends outwardly away from the longitudinal axis toward the lumen wall to deliver the therapeutic preparation from the delivery structure into the lumen wall or surrounding tissue.