Inhaler Refill Lockout Override Mechanism
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Solution Overview
Problem
Conventional medicinal inhalers, particularly pressurized metered dose inhalers (pMDIs), face challenges in coordinating the timing of dose release with inhalation, leading to inefficiencies and inaccuracies in medicament delivery, especially when used without a reusable assembly or in emergency situations.
Innovation Solution
A refill assembly with a lockout mechanism that requires coupling to a reusable assembly for operation, featuring a lockout override mechanism to allow dose release even when not coupled, ensuring accurate dosing and preventing misuse or accidental delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a lockout mechanism is implemented to prevent operation without reusable assembly, then patient safety and accurate dosing are improved, but device complexity increases
Solution Approach 1:
The inhaler is divided into two separate assemblies: a reusable assembly containing the actuator and control mechanisms, and a refillable canister assembly containing the medicament. The lockout mechanism is integrated into the reusable assembly to control access to the canister, allowing the canister to be replaced without replacing the entire inhaler device.
Solution Approach 2:
The lockout mechanism is pre-configured to engage automatically when the canister is removed from the reusable assembly, preventing accidental dosing before the override action is taken. The system prepares the locked state in advance to ensure safety.
Solution Approach 3:
An override mechanism serves as an intermediary between the lockout mechanism and the canister operation. This intermediary allows authorized users to temporarily bypass the lockout when necessary while maintaining the safety function during normal operation.
2Ease of operation
If a lockout override mechanism is added to allow operation without reusable assembly, then ease of operation in emergencies is improved, but device complexity increases
Solution Approach 1:
The override function is extracted as a distinct feature from the main lockout mechanism. The override button or mechanism is separate from the normal operation controls, allowing it to be added without fundamentally changing the core lockout functionality.
Solution Approach 2:
The override mechanism provides localized emergency access specifically at the canister interface, while the rest of the device maintains its normal locked operation. The override function is confined to a specific location and does not affect other parts of the device.
3Object-affected harmful factors
If the refill assembly is designed to require coupling with reusable assembly, then prevention of misuse and accidental dosing is improved, but adaptability decreases
Solution Approach 1:
The system transitions from a static locked state to a dynamic state when the override mechanism is activated. The lockout condition can change based on user input through the override, allowing the system to adapt between safety mode and emergency mode.
Solution Approach 2:
The operational parameters of the refill assembly change based on coupling status. When coupled with the reusable assembly, the system operates in normal mode with full functionality. When uncoupled, the lockout parameter changes to prevent operation, unless override is activated.
Data Source
AI summary
A refill assembly (129) for use in a medicinal inhaler (100). The refill assembly includes a patient port (110), and an adapter (118) configured to cause a dose of medicament to be released. The adapter is movable between a first position in which a dose of medicament is not released and a second position in which a dose of medicament is released. The refill assembly further includes a lockout mechanism positioned to lock the adapter in its first position, and a lockout override actuator (223). The lockout override actuator is movable between a first position in which the lockout mechanism is in a first locked state, and a second position in which the lockout mechanism is in a second unlocked state and the adapter is movable from its first position to its second position even when the refill assembly is not coupled to a reusable assembly.