Lockout Element for Drug Delivery Dispense Interface
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Solution Overview
Problem
Current medical devices for delivering multiple drug agents require complex user manipulations and lack a mechanism to prevent reuse of the dispense interface, which can lead to contamination and compromised purity of medicaments.
Innovation Solution
A dispense interface with a lockout element that mechanically prevents reattachment after initial use, ensuring the interface cannot be reused and maintaining the purity of the medicaments by employing a spring steel wireform or similar mechanism that changes position upon attachment and detachment from the drug delivery device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the dispense interface is designed to be reusable, then ease of operation is improved, but contamination risk and loss of substance increase
Solution Approach 1:
The dispense interface is designed as a single-use component that is discarded after one use. This eliminates the need for cleaning and sterilization, ensuring that no contamination can occur in subsequent uses. The interface is replaced with a fresh one for each patient, guaranteeing medicament purity while remaining simple and cost-effective.
Solution Approach 2:
A lockout element is incorporated into the dispense interface that mechanically prevents reattachment to the drug delivery device. This preliminary protective measure ensures that the interface cannot be reused, thereby preventing contamination risk before it can occur. The lockout element engages with a corresponding feature on the device to create a physical barrier against reuse.
2Reliability
If a lockout mechanism is added to prevent reuse, then reliability is improved, but device complexity increases
Solution Approach 1:
The lockout functionality is extracted as a separate, simple mechanical element rather than being integrated into the entire dispense interface system. The lockout element is a discrete component that can be easily manufactured and assembled, adding minimal complexity while providing reliable prevention of reuse. This modular approach allows the lockout feature to be independently optimized without complicating the rest of the system.
Solution Approach 2:
The lockout element acts as an intermediary mechanical feature between the dispense interface and the drug delivery device. It provides a simple binary state (locked/ unlocked) that effectively communicates whether the interface has been used, without requiring complex sensors, processors, or control systems. The intermediary nature of this mechanical latch keeps the overall system simple while ensuring reliability.
3Reliability
If the dispense interface is made single-use, then purity of medicaments is maintained, but loss of time increases
Solution Approach 1:
The lockout mechanism is pre-configured during manufacturing to automatically engage when the dispense interface is attached to the drug delivery device. This preliminary action ensures that the interface is locked out before any medicament delivery occurs, preventing reuse without requiring additional checks or actions during the usage process. The pre-set lockout feature eliminates the need for user intervention to prevent contamination.
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 lockout mechanism effectively prevents reuse of the dispense interface, thereby maintaining the integrity and purity of the medicaments, reducing the risk of contamination and simplifying the user experience by eliminating the need for complex reattachment checks.
Implementation Method 1
a lockout element arranged at least partially between an outer body of the dispense interface and an inner body of the dispense interface and maintained in a first position, wherein the lockout element in the first position is configured to move into a second position when the dispense interface is first attached and then removed from the drug delivery device
Data Source
AI summary
The invention is related to an apparatus comprising a dispense interface for use with a drug delivery device, the dispense interface comprising a lockout element being arranged at least partially between an outer body of the dispense interface and an inner body of the dispense interface and wherein the lockout element is configured to be removeably maintained in a first position, such that when the dispense interface is first attached and then removed from said drug delivery device, the lockout element moves into a second position, wherein the lockout element in the second position is configured to prevent said dispense interface from being reattached to a drug delivery device.