Analyte Sensor Storage Lockout for Sensitivity Protection
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Solution Overview
Problem
Medical devices, such as continuous glucose monitoring systems, can lose sensitivity due to improper storage conditions, leading to negative signal drifts and permanent underestimation of analyte concentrations, as users may not be aware of or adhere to the required storage conditions.
Innovation Solution
A medical system with an analyte sensor and a disabling device that includes a monitoring element which changes its mechanical properties when storage conditions are outside a specified range, preventing irreversible transcutaneous insertion into the body tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If users store medical devices without proper storage conditions monitoring, then ease of operation is improved, but reliability deteriorates due to loss of sensitivity and negative signal drifts
Solution Approach 1:
The storage monitoring system automatically tracks temperature, humidity, and storage duration without requiring user intervention. The system self-monitors storage conditions and autonomously determines whether the analyte sensor has been exposed to improper conditions, eliminating the need for users to manually track or remember storage requirements.
Solution Approach 2:
The patent replaces manual storage condition tracking with an electronic monitoring system that uses sensors, processors, and memory to automatically record and evaluate storage parameters. This substitution of mechanical/manual monitoring with electronic systems enables continuous, accurate tracking of storage conditions without user burden.
2Reliability
If users are made aware of and required to adhere to storage conditions, then reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The system performs self-monitoring and self-evaluation of storage conditions, automatically determining whether improper exposure has occurred without requiring user knowledge or action. The processor autonomously compares stored environmental data against acceptable ranges and makes the determination independently.
Solution Approach 2:
The system provides feedback to the user only when necessary - specifically when improper storage conditions are detected. The visual or audible indicator alerts users to the status of the analyte sensor based on automated evaluation, providing information only when the storage conditions warrant attention.
3Reliability
If a disabling device is added to prevent insertion under improper conditions, then reliability is improved, but device complexity increases
Solution Approach 1:
The monitoring system and disabling mechanism are integrated into a single unified device. The processor that evaluates storage conditions is the same processor that controls the insertion mechanism, and the visual indicator serves both as a display element and part of the overall system architecture. This merging reduces the number of separate components needed.
Solution Approach 2:
The processor performs multiple functions: it monitors environmental sensors, stores data in memory, evaluates storage conditions against criteria, controls the insertion mechanism, and drives the visual indicator. This multi-functionality eliminates the need for separate dedicated components for each function, reducing overall system complexity.
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
Prevents the use of medical devices stored under improper conditions, ensuring accurate analyte detection by ensuring the sensor is only inserted when stored within specified temperature and humidity ranges.
Implementation Method 1
the monitoring element being configured for undergoing a change in at least one mechanical property when storage conditions of the analyte sensor are outside a specification range
Data Source
AI summary
A medical system and a method for monitoring the storage conditions of at least one medical system are disclosed. The medical system includes at least one analyte sensor for detecting at least one analyte in a bodily fluid, the analyte sensor being configured for at least partial transcutaneous insertion into a body tissue of a user; and at least one disabling device operably connected to the analyte sensor. The disabling device includes at least one monitoring element wherein the monitoring element is configured for undergoing a change in at least one mechanical property when storage conditions of the analyte sensor are outside a specification range. The mechanical property change is configured such that the transcutaneous insertion of the analyte sensor into the body tissue is irreversibly prevented.