Supplemental Device Activation Mechanism for Medicament Delivery
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Solution Overview
Problem
Existing medicament delivery devices face challenges in automatically activating communication systems before the sterility barrier is breached, leading to potential issues with power management and user compliance, as well as difficulties in modifying existing designs to incorporate wireless communication systems without triggering regulatory problems or causing premature battery drain.
Innovation Solution
A supplemental device with an integrated activation mechanism that powers up before the sterility barrier is breached, using a battery initially disconnected and activated by the removal sequence of the protective cap, allowing communication with external devices without modifying the existing device design, and utilizing a switch or insulating material to maintain the battery in a disconnected state until the cap is removed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the communication system is continuously powered, then data transmission capability is maintained, but battery lifetime is reduced
Solution Approach 1:
The power supply is activated periodically based on detected events rather than continuously. The controller activates the power supply only when specific events are detected (e.g., protective cap removal, needle insertion, medicament delivery completion), allowing the communication system to transmit data at critical moments while conserving battery power during idle periods.
Solution Approach 2:
The system uses the medicament delivery device's own operational events (cap removal, needle insertion, delivery completion) to trigger communication activations. These inherent device operations serve as the activation mechanism, eliminating the need for separate user actions or continuous power consumption while ensuring data is transmitted when most relevant.
2Extent of automation
If the protective cap removal sequence is used to activate the supplemental device, then automatic activation is achieved, but the sterility barrier may be compromised
Solution Approach 1:
The protective cap is designed to allow a limited, controlled movement sequence that is sufficient to activate the supplemental device but insufficient to remove the needle shield or breach the sterility barrier. The cap can be partially removed along the longitudinal axis to trigger activation, while the needle shield remains in place to maintain sterility, requiring a separate, more substantial removal action for complete cap removal.
Solution Approach 2:
The protective cap and needle shield are separated into distinct functional components. The cap's partial removal motion is decoupled from needle shield removal, allowing the cap to move independently for activation purposes while the needle shield stays fixed to protect the needle. This segmentation enables independent control of activation and sterility protection functions.
3Adaptability or versatility
If existing device design is modified to incorporate wireless communication, then functionality is improved, but regulatory approval becomes difficult
Solution Approach 1:
The wireless communication system is extracted as a separate, attachable supplemental device rather than being integrated into the core medicament delivery device. This allows the communication functionality to be added without modifying the original device design, preserving regulatory approval while enabling wireless data transmission capabilities through an external attachment.
Data Source
AI summary
The present disclosure relates to an activation system for a supplemental device that is attached to an existing design of a medicament delivery device, where a movement applied on the protective cap or other covering of the medicament delivery device triggers the activation mechanism for re-establishing electrical contacts to close a circuit between a battery module and a power source, thus activating the battery module. The activation mechanism is configured to not intervene with the sterility of the dose delivery outlet. Thus, the supplemental device can be activated at any time before removal of the protective cap or other covering. The supplemental device can further have a transmitter for communicating information about the use of the medicament delivery device to an external device, such as a smart device. Memory storage elements can also be included having unique identification data. The present disclosure also relates to a medicament delivery device having the supplemental device attached.