Ingestible Device Trans-epithelial GI Delivery

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Solution Overview

Problem

Current methods for delivering therapeutic agents to the gastrointestinal (GI) tract face challenges in achieving effective systemic exposure, particularly due to low oral bioavailability and the need for invasive administration routes, which can be painful and inconvenient.

Innovation Solution

Ingestible devices designed to deliver therapeutic agents directly to the GI tract via trans-epithelial, epithelial, or topical delivery modes, utilizing a housing with a drive force generator and nozzles to provide controlled pressure and jet velocity for targeted delivery to the submucosa, mucosa, or lumen, ensuring systemic exposure and local action.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If oral administration is used to deliver therapeutic agents, then convenience is improved, but systemic exposure is reduced due to low oral bioavailability

Engineering Contradiction:

ImproveconvenienceVSAvoidsystemic exposure

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The device segments the delivery process into distinct phases: oral ingestion of the capsule, targeted release at the small intestine, and controlled trans-epithelial delivery through nozzles. This segmentation allows the device to maintain oral administration convenience while achieving reliable systemic exposure through bypassing the liver first-pass metabolism and directly delivering to the highly vascularized submucosal layer

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The ingestible device acts as an intermediary system between oral administration and systemic circulation. It includes a capsule housing, drive mechanism, nozzle assembly, and control system that collectively mediate the transition from oral intake to direct submucosal delivery, enabling both convenience and reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If invasive administration routes are used to achieve systemic exposure, then reliability is improved, but patient discomfort increases

Engineering Contradiction:

Improvesystemic exposureVSAvoidpatient discomfort

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device enables self-service delivery where the patient swallows the capsule themselves without requiring medical personnel or invasive procedures. The capsule autonomously navigates to the small intestine, activates its drive mechanism, and delivers the therapeutic agent through trans-epithelial injection, eliminating the need for painful clinical interventions while maintaining reliable systemic exposure

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

Instead of injecting from outside the body (invasive route), the device inverts the approach by having the patient swallow a capsule that delivers the agent from the inside. This inversion transforms a traditionally invasive procedure into a non-invasive oral administration that achieves the same systemic exposure reliability

Inventive Principle:

Principle #13The other way round (Inversion)

3Reliability

If high pressure delivery is used to achieve trans-epithelial delivery, then systemic uptake is improved, but device complexity increases

Engineering Contradiction:

Improvesystemic uptakeVSAvoiddevice complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The device merges multiple functions into a single integrated capsule: the housing contains both the therapeutic agent reservoir and the drive mechanism; the nozzles serve as both delivery channels and injection needles; the control system integrates sensing and actuation. This merging reduces overall device complexity while maintaining the high pressure delivery capability needed for trans-epithelial penetration and reliable systemic uptake

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The device employs parameter changes in the drive mechanism to generate high pressure pulses for trans-epithelial delivery. By controlling pressure, flow rate, and pulse duration, the system achieves sufficient force to penetrate the epithelial barrier and reach the submucosal layer, thereby ensuring reliable systemic uptake without requiring excessively complex hardware

Inventive Principle:

Principle #35Parameter changes

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 achieve high systemic uptake of therapeutic agents, with up to 25% relative to intravenous or subcutaneous administration, while providing localized effects, and are designed for convenience and reduced patient discomfort.

Implementation Method 1

The ingestible device has a drive force generator that provides an internal pressure of from about 225 psig to about 400 psig

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

The ingestible device is configured to deliver the dispensable substance at a peak jet velocity of from about 25 meters per second to about 45 meters per second

Methodology Applied

Scientific EffectJet flow: Jet

Data Source

PatentUS20240252795A1Ingestible device for delivery of therapeutic agent to the gastrointestinal tract

Publication Date: 2024.08.01 BT BIDCO INC

AI summary

An ingestible device, includes a storage reservoir configured to store a dispensable substance and a pressurized chamber configured so that, when a restraining force is removed from the pressurized clamber, the dispensable substance exits the ingestible device via openings in the ingestible device.