Sensor Inserter Disposal Lockout Mechanism
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Solution Overview
Problem
Existing sensor inserters for physiological characteristic sensors, such as glucose sensors, often lack a mechanism to prevent reuse, which can compromise sterility and lead to improper use, necessitating a disposal lockout state to ensure single-use compliance.
Innovation Solution
A sensor inserter with a striker assembly that moves through defined tracks within its housing, engaging a lock beam to transition from a cocked state to a disposal state, inhibiting further use by preventing movement back to the initial state, thus ensuring a new inserter is used for each sensor replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the sensor inserter is configured as a one-time use device, then sterility and proper force application are ensured, but device complexity increases due to the disposal lockout mechanism
Solution Approach 1:
The lock beam is pre-configured in a first position that allows striker assembly movement. After single use, the lock beam transitions to a second position that prevents reuse, eliminating the need for complex active locking mechanisms while ensuring sterility
Solution Approach 2:
The sensor inserter is designed as a disposable device with a simple mechanical lockout system using a lock beam and striker assembly. The low-cost mechanical design allows the device to be discarded after single use, ensuring sterility without requiring complex reusable locking mechanisms
2Reliability
If the sensor inserter includes a disposal lockout state, then reuse is prevented, but device complexity increases due to additional mechanical components
Solution Approach 1:
The lock beam is pre-configured in a first position that allows striker assembly movement. After single use, the lock beam transitions to a second position that prevents reuse, eliminating the need for complex active locking mechanisms while ensuring sterility
Solution Approach 2:
Complex electronic or active mechanical locking systems are replaced with a simple passive mechanical lockout using a lock beam and striker assembly. The lockout state is achieved through the natural mechanical interaction between these components after the insertion action, rather than requiring active control systems
3Reliability
If the lock beam engages with the track system to prevent reuse, then manufacturing precision requirements increase
Solution Approach 1:
The disposal lockout function is segmented into distinct components: the lock beam with its engagement feature, the striker assembly, and the track system with defined positions. This segmentation allows each component to be manufactured and assembled independently, reducing the cumulative precision requirements compared to a fully integrated mechanism
Solution Approach 2:
The lock beam is pre-configured in a first position that allows striker assembly movement. After single use, the lock beam transitions to a second position that prevents reuse, eliminating the need for complex active locking mechanisms while ensuring sterility
Data Source
AI summary
A sensor inserter for a physiological characteristic sensor includes a housing that defines a track system that extends from a bottom of the housing toward a top of the housing. The sensor inserter includes a striker assembly movable relative to the housing between a first state, a second, cocked state and a third, disposal state. The striker assembly is movable from the second, cocked state to the third, disposal state to couple the physiological characteristic sensor to an anatomy. The striker assembly includes a lock beam that engages with the track system as the striker assembly moves between the first state, the second, cocked state and the third, disposal state. In the third, disposal state the lock beam inhibits movement of the striker assembly from the third, disposal state to the first state.