Reconfigurable Biasing Element for High-Viscosity Therapeutic Delivery
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Solution Overview
Problem
Current parenteral delivery systems face challenges in administering high-viscosity protein therapeutics due to the need for high pressures, which can cause discomfort and require complex designs that may lead to device damage and patient anxiety, especially when transitioning from intravenous to subcutaneous delivery methods.
Innovation Solution
A therapeutic agent delivery system with a reconfigurable biasing element that transitions from a higher to a lower energy storage configuration, allowing for controlled needle deployment and retraction, facilitated by a user input and electronics assembly, enabling efficient and safe delivery of high-viscosity fluids in a compact and user-friendly format.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high pressure is used to deliver high-viscosity therapeutic fluids, then delivery reliability is improved, but device complexity and risk of damage increase
Solution Approach 1:
The spring mechanism is designed to be reconfigurable between locked and unlocked states, allowing dynamic adjustment of the energy storage configuration. This enables the device to adapt its mechanical properties to match delivery requirements while maintaining simplicity in each state
Solution Approach 2:
The biasing element's energy storage configuration is changed between locked (higher energy) and unlocked (lower energy) states. This parameter change allows the same component to provide different force levels appropriate for different delivery conditions without requiring multiple components
2Productivity
If high pressure is used to push high-viscosity fluids through the device, then delivery efficiency is improved, but patient discomfort increases
Solution Approach 1:
The spring mechanism delivers pressure in a controlled sequence: loading phase (energy storage), delivery phase (pressure application), and retraction phase (pressure release). This periodic action allows efficient delivery while providing intervals that reduce continuous pressure-related discomfort
Solution Approach 2:
The reconfigurable spring allows dynamic adjustment of pressure application. The device can transition between high-pressure delivery mode and low-pressure retraction mode, optimizing productivity during delivery while minimizing harmful effects during non-delivery phases
3Ease of manufacture
If a fixed spring shape is used for pressure delivery, then manufacturing simplicity is improved, but design flexibility decreases
Solution Approach 1:
The biasing element is designed with reconfigurable geometry that can change between locked and unlocked states. This dynamic geometric transformation allows a single manufactured component to provide multiple design configurations, maintaining manufacturing simplicity while achieving design flexibility
4Power
If large energy is stored in the spring for high-viscosity fluid delivery, then delivery capability is improved, but risk of plastic part damage increases
Solution Approach 1:
The spring mechanism transitions between locked (high energy) and unlocked (low energy) configurations. This dynamic reconfiguration allows high power delivery when needed while reducing stored energy during other phases to protect plastic components from creep damage
Solution Approach 2:
The system alternates between high-energy storage/loading phases and low-energy delivery/retraction phases. This periodic cycling of energy levels provides sufficient power for viscous fluid delivery while limiting continuous high-energy exposure that would damage plastic parts
5Extent of automation
If spring-based auto-injector is used for needle deployment, then automation is improved, but patient anxiety increases due to sound
Solution Approach 1:
The spring mechanism operates in controlled periodic cycles with distinct phases. By timing the needle deployment to occur during specific phases and controlling the rate of energy release, the automation is maintained while acoustic emissions are minimized to reduce patient anxiety
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-concentration, high-viscosity protein therapeutics with reduced patient discomfort and device complexity, ensuring reliable and efficient delivery while minimizing device damage and anxiety.
Implementation Method 1
a biasing element that is reconfigurable from a higher energy storage configuration to a lower energy storage configuration... The biasing element thereby 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 passageway, a therapeutic agent carried in the passageway, and a needle in communication with the passageway. The therapeutic agent delivery assembly is translatable relative to the housing from a stowed configuration to a deployed configuration, and from the deployed configuration to a retracted configuration. The system further includes a user input configured to be actuated by a user, and actuation of the user input translates the therapeutic agent delivery assembly from the stowed configuration to the deployed configuration. The system further includes a retraction mechanism that translates the therapeutic agent delivery assembly from the deployed configuration to the retracted configuration.