Therapeutic Fluid Delivery Assembly With Controlled Needle Retraction
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Solution Overview
Problem
Existing delivery methods for high-viscosity therapeutic fluids, such as protein therapeutics, face challenges in self-administration due to high forces required, potential damage to plastic parts, and inability to modify pressure profiles, leading to patient discomfort and reduced compliance.
Innovation Solution
A therapeutic agent delivery system with a housing and a translatable therapeutic agent delivery assembly, utilizing a retraction mechanism involving an inflatable device and a valve system to facilitate self-administration of high-viscosity fluids, allowing for controlled delivery and retraction of the needle.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a spring-driven auto-injector is used to deliver high-viscosity therapeutic fluids, then the delivery mechanism is simple and reliable, but the spring must be large and store excessive energy that can damage plastic parts and cause patient discomfort
Solution Approach 1:
The patent replaces the traditional spring-driven mechanical system with a magnetic field-based actuation system. A magnet is positioned to engage a ferromagnetic component on the plunger, enabling delivery through magnetic force rather than mechanical spring pressure. This substitution eliminates the need for large energy-storing springs and reduces stress on plastic components while maintaining reliable delivery of high-viscosity fluids.
Solution Approach 2:
The patent modifies the pressure-time profile by controlling the release characteristics of the magnetic field actuation. Instead of the fixed, rapid pressure spike from a spring mechanism, the magnetic system allows for adjusted pressure parameters that reduce peak forces on plastic parts while maintaining adequate delivery pressure for high-viscosity formulations.
2Volume of moving object
If the concentration of therapeutic protein is increased to deliver the same amount in smaller volume, then the injection volume is reduced, but the viscosity increases making delivery more difficult
Solution Approach 1:
The magnetic field actuation system provides controlled force application that is better suited for high-viscosity, high-concentration formulations than spring pressure. The magnetic force can be applied more gradually and uniformly, reducing the peak forces needed while maintaining adequate delivery pressure for concentrated proteins.
Solution Approach 2:
The patent introduces a dynamic, adjustable actuation mechanism through the magnetic field that can adapt to the viscosity characteristics of different formulations. The magnetic engagement and release can be tuned to match the flow characteristics of high-concentration proteins, providing optimal force application throughout the delivery process.
3Force
If a large spring is used to store enough energy for high-viscosity fluid delivery, then the delivery pressure is sufficient, but the device footprint increases and design flexibility is reduced
Solution Approach 1:
The magnetic field actuation system eliminates the need for large energy-storing springs. The magnet and ferromagnetic plunger components occupy significantly less space than a spring capable of storing equivalent energy, reducing the device footprint while maintaining sufficient delivery pressure for high-viscosity fluids.
Solution Approach 2:
The magnetic system allows for adjustable force parameters that can be optimized for different formulation viscosities without requiring physical changes to the spring dimensions. This provides design flexibility while maintaining adequate delivery pressure.
4Device complexity
If spring-based auto-injectors are used for high-viscosity fluids, then the mechanism is simple, but the sound generated causes patient anxiety and reduced compliance
Solution Approach 1:
The magnetic field actuation system replaces the noisy spring-compression-and-release mechanism with a quieter magnetic engagement process. The magnetic field can be activated more gradually and silently, significantly reducing the audible noise that causes patient anxiety while maintaining the functional simplicity of the delivery mechanism.
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
Enables self-administration of high-viscosity therapeutic fluids with minimal patient discomfort and improved compliance by providing a controlled delivery and retraction mechanism, suitable for high-concentration protein formulations.
Implementation Method 1
The first chamber delivers the fluid to the second chamber. The inflatable device thereby inflates and translates the therapeutic agent delivery assembly from the deployed configuration to the retracted configuration.
Data Source
AI summary
A therapeutic agent delivery system includes a therapeutic agent delivery assembly carried by a housing. The therapeutic agent delivery assembly includes a chamber including a first passageway, a therapeutic agent carried in the first passageway, and a needle in communication with the first passageway. The therapeutic agent delivery assembly is translatable relative to the housing from a stowed configuration to a deployed configuration. The therapeutic agent delivery assembly is also translatable relative to the housing from the deployed configuration to a retracted configuration. The system further includes a user input that is actuatable to translate the therapeutic agent delivery assembly from the stowed configuration to the deployed configuration. The system further includes a retraction mechanism that is actuatable to translate the therapeutic agent delivery assembly from the deployed configuration to the retracted configuration.