Injection Pen Clutch Control for Maximum Dose Limiting
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Solution Overview
Problem
Current drug delivery devices, especially variable dose injection devices, face challenges in efficiently limiting the maximum dose that can be set and delivered, which is not suitable for all types of medications, such as long-acting and short-acting insulins, and can lead to user errors due to the need for significant engagement and complexity.
Innovation Solution
A drug delivery device with an electronically activated clutch that dynamically limits the maximum settable dose by locking or disengaging the dial grip from the dose setting mechanism, using a solenoid-activated clutch or a bi-stable magnetic clutch to prevent further dose selection once a preselected threshold is reached, allowing for safe and accurate dose delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a variable dose injection device is used to allow flexible dose selection, then adaptability is improved, but device complexity increases and user errors occur due to significant engagement required
Solution Approach 1:
The device pre-limits the maximum diallable dose through mechanical or electronic means before the user operates the device. This preliminary action prevents users from selecting doses beyond the safe threshold, thereby reducing engagement complexity while maintaining adaptability within safe limits.
Solution Approach 2:
The patent replaces complex mechanical engagement systems with simpler electronic or magnetic field-based dose limitation mechanisms. This substitution reduces the mechanical engagement complexity while preserving the ability to flexibly select doses within predetermined safe limits.
2Reliability
If a dose limiting mechanism is added to prevent overdose, then reliability is improved, but device complexity increases
Solution Approach 1:
The device automatically limits the maximum diallable dose through self-contained mechanical or electronic mechanisms without requiring additional user actions or complex external systems. This self-service approach enhances dose safety while minimizing the added complexity.
Solution Approach 2:
The patent introduces intermediary elements such as magnetic fields or electronic sensors that mediate between the user's dialing action and the actual dose selection. These intermediaries provide automatic dose limiting, improving reliability while keeping the overall mechanism relatively simple.
3Ease of operation
If a solenoid or magnetic clutch is used to limit maximum dose, then ease of operation is improved, but device complexity increases
Solution Approach 1:
The patent replaces traditional mechanical clutch mechanisms with solenoid or magnetic field-based clutch systems. This substitution improves ease of operation by enabling automatic engagement and disengagement of the dose limitation mechanism, while the electronic control simplifies the overall system architecture compared to purely mechanical solutions.
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 solution allows users to easily set and deliver doses up to a predetermined value without further engagement, reducing the risk of errors and maintaining device simplicity while ensuring accurate dose management, thus enhancing user safety and operational efficiency.
Implementation Method 1
using a solenoid-activated clutch
Implementation Method 2
bi-stable magnetic clutch
Data Source
AI summary
The present disclosure refers to a drug delivery device and to a method of operating the same. The device includes a housing, a dial grip manually operable by a user for setting an individual dose to be delivered by the device, a dose setting and drive mechanism, a clutch including two clutch members for rotationally coupling and de-coupling the dial grip to the housing and/or to the dose setting and drive mechanism, at least one processor, a sensor arrangement operable to generate measurement data indicative of the dose setting operation, and a power source connected to the at least one processor. The drug delivery device includes a clutch actuator operable by the at least one processor to trigger a switch of the state of the clutch. The at least one processor is configured to operate the clutch actuator if the measurement data generated by the sensor arrangement reaches a threshold.