GI Retentive Device with Resilient Locking
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Solution Overview
Problem
Current gastric retentive drug delivery systems face challenges in maintaining prolonged drug release in specific regions of the gastrointestinal tract, such as the stomach and small intestine, due to variability in GI physiology and conditions, leading to unpredictable drug absorption and efficacy.
Innovation Solution
A device configured to transfer from a closed to an expanded configuration, retained at a predetermined location in the GI tract using a resiliently deformable member and locking assembly, allowing for prolonged drug release while minimizing material usage and ensuring safety, with features like chyme flow and adjustable retention and emptying mechanisms.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If a device is designed to be retained in the GI tract for prolonged periods to enable continuous drug release, then the duration of drug release is improved, but the device complexity increases due to the need for retention mechanisms and safety controls
Solution Approach 1:
The device is divided into multiple functional segments: a retention mechanism (balloon or mesh structure), a drug delivery component (capsule or reservoir), and a release control system. This segmentation allows each component to perform its specific function independently, managing complexity through modular design while achieving prolonged retention and controlled drug release.
Solution Approach 2:
The device incorporates dynamic elements that allow it to adapt to GI tract conditions. The retention mechanism can inflate or expand in response to physiological signals, and the release system can be activated by pH changes, enzymes, or mechanical stimulation. This dynamic behavior enables prolonged retention without requiring complex active control systems.
2Reliability
If the device is made to be safe for long-term residence in the GI tract, then the reliability is improved, but the material usage and device size increase
Solution Approach 1:
The device employs thin-walled flexible structures such as balloons or mesh networks that provide sufficient mechanical strength and biocompatibility for long-term residence without requiring thick, material-intensive walls. These thin-film structures maintain safety and reliability while minimizing material usage and reducing overall device size.
Solution Approach 2:
The device utilizes composite materials combining biocompatible polymers, metal alloys, or natural fibers that provide high strength-to-weight ratios. These composite materials enhance the device's safety profile for long-term GI residence while using minimal material quantity, as the materials themselves provide both structural integrity and biocompatibility.
3Manufacturing precision
If the device is designed to release drug at specific GI locations, then the manufacturing precision is improved, but the device complexity increases due to location-specific retention and release mechanisms
Solution Approach 1:
The device incorporates location-specific features such as pH-sensitive coatings, enzyme-triggered release zones, or geometric retention structures that are optimized for particular GI regions (stomach, small intestine, colon). These local quality variations enable precise drug release at target locations without requiring the entire device to be complex; only the relevant portions are specialized.
Solution Approach 2:
The device utilizes physiological parameter changes (pH, temperature, enzyme concentration, motility patterns) as triggers for drug release. By designing the release mechanism to respond to these natural parameter variations, the system achieves location-specific drug delivery without complex active control systems, as the body's own physiological parameters serve as the control signal.
4Quantity of substance
If the device uses minimal material to reduce exposure, then the quantity of substance is reduced, but the structural integrity for prolonged retention may be compromised
Solution Approach 1:
The device employs thin-walled flexible structures that provide adequate structural integrity through their geometric configuration rather than material thickness. The flexible shell design maintains sufficient strength for prolonged retention while using minimal material, as the structure's shape and elasticity provide the necessary mechanical properties without requiring thick walls.
Solution Approach 2:
The device utilizes curved and spherical geometries that provide high structural efficiency with minimal material. Spheroidal shapes have optimal strength-to-volume ratios and can withstand GI tract forces while using less material than flat or angular structures. The curvature distributes mechanical stresses evenly, maintaining structural integrity with thin walls and minimal material exposure.
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 enables prolonged, predictable drug release at specific GI locations, improving therapeutic efficacy and safety by maintaining structural integrity and minimizing material exposure, while allowing for easy administration and extended shelf-life.
Implementation Method 1
The device comprises a resiliently deformable member configured to force the coupling heads together to bend the arms
Data Source
AI summary
A device for temporary residence at a predetermined location of the gastrointestinal tract of a subject is described. The device transfers from a closed configuration into an expanded configuration. The device is retained at the predetermined location and transfers from the expanded configuration into an emptying configuration in which the device moves past the predetermined location. The device enables localized medical methods in the gastrointestinal tract of the subject.