Ingestible GI Drug Delivery With Force-Driven Trans-Epithelial Dosing
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Solution Overview
Problem
Existing methods for delivering therapeutic agents to the gastrointestinal (GI) tract are inefficient, particularly for achieving systemic uptake, and often involve invasive administration routes that cause discomfort and compliance issues.
Innovation Solution
Ingestible devices configured for trans-epithelial, epithelial, and topical delivery of therapeutic agents directly to the GI tract, utilizing a force-driven mechanism to deliver agents past or onto the epithelial layer, with specific performance parameters to ensure effective delivery to the submucosa, mucosa, or lumen surfaces.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If invasive administration routes are used to deliver therapeutic agents, then delivery effectiveness is improved, but patient discomfort and compliance issues worsen
Solution Approach 1:
The patent replaces invasive mechanical injection systems with an ingestible device that uses controlled pressure and force-driven mechanisms to deliver therapeutic agents through the GI tract epithelium. The device uses a piston, spring, and nozzle system to create high-velocity jets that penetrate tissue without external injection, substituting surgical mechanics with controlled internal pressure dynamics.
Solution Approach 2:
The ingestible device acts as an intermediary between the therapeutic agent and the target tissue, delivering the agent through the GI epithelium via controlled pressure release. The device includes a housing, piston, and nozzle system that mediates the transfer of the therapeutic agent from the lumen into the submucosa or mucosa, avoiding both invasive injection and inefficient oral absorption.
2Ease of operation
If oral administration is used for therapeutic agents, then patient compliance is improved, but bioavailability worsens due to low systemic uptake
Solution Approach 1:
The patent applies local quality by delivering the therapeutic agent directly to specific regions of the GI tract (submucosa, mucosa, or epithelium) rather than relying on systemic absorption after oral administration. The device creates localized high-concentration delivery zones through controlled pressure release, ensuring the agent reaches its target before degradation or excretion can occur.
Solution Approach 2:
The invention transitions from the traditional oral absorption pathway (lumen → bloodstream) to a trans-epithelial delivery pathway (lumen → epithelium → submucosa/mucosa → bloodstream). This dimensional change in delivery route allows the agent to bypass first-pass metabolism and achieve higher bioavailability while maintaining oral administration convenience.
3Reliability
If force-driven delivery mechanisms are used to achieve trans-epithelial delivery, then systemic uptake is improved, but device complexity worsens
Solution Approach 1:
The device employs a nested structure where the piston is contained within the housing, the spring is compressed within the piston assembly, and the therapeutic agent is stored within the piston chamber. This nested arrangement allows multiple functional components (pressure generation, containment, delivery) to be integrated in a compact, swallowable form factor despite the complexity of the force-driven mechanism.
Solution Approach 2:
The spring is pre-compressed during device assembly, storing potential energy before ingestion. The piston is pre-positioned to seal the agent chamber, and the nozzle is pre-aligned for optimal jet delivery. These preliminary actions ensure that upon activation (either by degradation of a restraining element or mechanical trigger), the device immediately generates the necessary force for trans-epithelial delivery without requiring complex real-time control systems.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The ingestible devices provide safe, effective, and reliable delivery of therapeutic agents, achieving systemic uptake of at least 10% compared to intravenous or subcutaneous administration, while minimizing discomfort and improving patient compliance.
Implementation Method 1
a spring in the interior of the housing
Implementation Method 2
a gas cylinder in the interior of the housing
Data Source
AI summary
Ingestible devices can directly deliver therapeutic agents to desired tissue(s) of the GI tract of a subject, such as the submucosa, the mucosa, and/or the mucus layer of the GI tract, and methods of using the same. The ingestible devices can deliver therapeutic agents in a safe, effective, and reliable manner. The disclosure also provides pharmaceutical compositions for use in methods of treating a disease or condition in a subject in need thereof.