Thermally Controlled Gastrointestinal Residence Device

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Solution Overview

Problem

Medication non-adherence, particularly with complex or prolonged regimens, poses a significant barrier to effective clinical care, as current pharmacologic solutions are limited and invasive, and there is a need for technologies that can easily deploy and selectively retain therapeutic devices in the gastrointestinal tract.

Innovation Solution

A thermally controlled residence device comprising a plurality of links and flexible hinges that can reconfigure from a contracted to an expanded configuration upon exposure to a threshold temperature, allowing for selective weakening and disassembly, enabling easy passage through the gastrointestinal tract.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of moving object

If the residence device is designed to remain intact in the gastrointestinal tract for extended periods, then drug delivery efficacy is improved, but device removal and passage through the tract becomes difficult

Engineering Contradiction:

Improveresidence time in gastrointestinal tractVSAvoiddevice passage and removal

Core Design Contradiction:

Duration of action of moving objectVSEase of operation

Solution Approach 1:

The residence device is divided into multiple links connected by flexible hinges, creating a modular structure that can be segmented for easier passage through the gastrointestinal tract while maintaining structural integrity during the residence period

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The device utilizes temperature-responsive materials that change their mechanical properties at specific temperatures, allowing the device to transition from a stable, intact configuration during gastric residence to a more flexible, passable configuration when exposed to temperature changes during removal

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If the residence device is designed to be easily removable, then device passage through the tract is improved, but maintaining structural integrity for extended drug delivery becomes difficult

Engineering Contradiction:

Improvedevice removalVSAvoidstructural integrity

Core Design Contradiction:

Ease of operationVSStrength

Solution Approach 1:

The device employs composite materials with temperature-responsive properties that provide structural integrity at gastrointestinal temperatures while allowing controlled disassembly or configuration change when exposed to different temperatures during removal procedures

Inventive Principle:

Principle #40Composite materials

3Reliability

If invasive devices are used to ensure drug delivery, then drug delivery efficacy is improved, but patient comfort and acceptance deteriorates

Engineering Contradiction:

Improvedrug delivery efficacyVSAvoidinvasiveness

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The residence device utilizes flexible hinges and link segments that allow the structure to conform to the gastrointestinal tract geometry, reducing mechanical irritation and improving patient comfort while maintaining effective drug delivery through the flexible but structurally sound design

Inventive Principle:

Principle #30Flexible shells and thin films

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 device effectively addresses medication adherence by providing a reconfigurable and removable therapeutic delivery system that can maintain a therapeutic compound in the gastrointestinal tract for extended periods while ensuring safe passage, enhancing drug stability and delivery efficacy.

Implementation Method 1

The coupling is configured to weaken or decouple a connection between the first link segment and the second link segment when exposed to a temperature greater than a threshold temperature

Methodology Applied

Scientific EffectThermal weakening: Thermal Expansion

Implementation Method 2

Each hinge pivotably connects at least two links of the plurality of links to form a flexible structure such that the residence device is reconfigurable from a first contracted configuration to a second expanded configuration

Methodology Applied

Scientific EffectFlexibility: Elasticity

Implementation Method 3

When the one or more dissolvable capsules dissolve, the residence device expands from the first contracted configuration to the second expanded configuration

Methodology Applied

Scientific EffectDissolution: Solvation

Data Source

PatentUS11648381B2Thermally controlled residence devices

Publication Date: 2023.05.16 MASSACHUSETTS INST OF TECH

AI summary

Residence devices for long term delivery of therapeutic compounds and/or for sensing one or more relevant parameters in vivo are disclosed. In one embodiment, a residence device may include a plurality of links interconnected by a corresponding plurality of flexible hinges to permit the residence device to be deformed into a contracted configuration and subsequently permitted to return to an expanded configuration once positioned in a desired location, such as the stomach, of a subject. In some instances, at least a portion of the interconnected links may include a first link segment, a second link segment, and a coupling that selectively connects the first link segment to the second link segment. The coupling may be configured to weaken or decouple a connection between the first link segment and the second link segment when exposed to a temperature greater than a threshold temperature to selectively weaken and/or disassemble the residence device.