Auto-inflatable patch assembly for delivery of therapeutic agents to an intestinal wall
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Solution Overview
Problem
Existing gas-generating devices for orally administered intestinal drug delivery face challenges in ensuring effective deployment of penetrating needles, stability in humid environments, and consistent gas generation at the desired location and time within the GI tract, while maintaining durability during deployment.
Innovation Solution
An auto-inflatable patch assembly with a pliable and inflatable patch having gas-impermeable walls and auxiliary gas-generating reaction chambers, configured to constrain gas and have a water-permeable outer surface, which houses a water-sensitive gas-generating formulation, allowing controlled gas release to inflate the patch and deploy penetrating needles into the intestinal wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a water-sensitive gas-generating formulation is used to drive patch inflation, then the patch can be deployed effectively, but the device becomes unstable in humid environments during shelf life
Solution Approach 1:
The device is divided into separate compartments: a water-sensitive gas-generating formulation compartment and a patch compartment. The formulation is contained within a soluble capsule that separates from the patch, preventing premature reaction while maintaining deployment capability. This segmentation allows the formulation to remain stable during shelf life while still enabling effective deployment when exposed to intestinal fluid.
Solution Approach 2:
A soluble capsule acts as an intermediary container for the water-sensitive gas-generating formulation. This capsule protects the formulation from premature reaction during storage and transport, while still allowing it to dissolve and react when exposed to intestinal fluid in the body, thus mediating between stability requirements and deployment effectiveness.
2Strength
If the patch is designed to be gas-impermeable to maintain pressure, then structural integrity is improved, but water absorption to deliver fluid to reactants is hindered
Solution Approach 1:
The device separates the gas-impermeable patch compartment from the water-absorbing formulation compartment. The patch maintains gas impermeability for structural integrity and pressure maintenance, while the formulation compartment absorbs water from the intestinal environment to drive the gas-generating reaction. This segmentation allows both requirements to be satisfied simultaneously without compromise.
Solution Approach 2:
Different regions of the device have different permeability properties: the patch is gas-impermeable to maintain pressure and structural integrity, while the formulation compartment is water-permeable to enable reactant dissolution. This local differentiation of material properties allows the device to simultaneously achieve both gas containment and water absorption functions.
3Stability of the object's composition
If the gas-generating reaction is delayed until after swallowing, then the device remains stable during storage, but the deployment timing must be precisely controlled
Solution Approach 1:
The soluble capsule serves as a timing intermediary that remains intact during storage and transport, protecting the water-sensitive formulation from premature reaction. Upon swallowing and exposure to intestinal fluid, the capsule dissolves and triggers the gas-generating reaction, providing automatic timing control without requiring external actuation mechanisms.
Solution Approach 2:
The device uses the intestinal environment itself as the trigger for deployment. The water in the intestinal tract automatically activates the water-sensitive gas-generating formulation when the capsule dissolves, eliminating the need for external control systems. The body's own physiological conditions provide the timing signal for deployment.
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 patch assembly provides a consistent and controlled pressure for extended periods, effectively delivering therapeutic agents through the intestinal lumen wall, maintaining structural integrity and preventing gas leakage, while ensuring the needles penetrate the intestinal wall for drug delivery.
Implementation Method 1
house a water-sensitive gas-generating formulation, which generates gas upon exposure to water to inflate the patch
Implementation Method 2
reaction chamber walls being configured to constrain gas and having at least a portion being a water-permeable outer surface
Data Source
AI summary
Embodiments of the invention provide an auto-inflatable patch assembly for drug delivery within a lumen, having: a pliable and inflatable patch having water and gas-impermeable walls, which define an internal chamber and an array of penetrating needles disposed on a surface thereof; one or more auxiliary gas-generating reaction chambers distinguished from and fluidly connected to the inflatable patch, said reaction chamber defined by pliable reaction chamber walls that house a water-sensitive gas-generating formulation; said reaction chamber walls having at least a portion being a water-permeable outer surface, wherein the patch assembly is configured such that each gas-generating formulation or a set thereof, is retained within its respective auxiliary gas-generating reaction chamber during inflation.