Electronic single use chemical diagnostics device
Inventors
Jensen, Morten Juel • SCABOO, Kristian Michael
Assignees
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Publication Number
US-12584901-B2
Publication Date
2026-03-24
Expiration Date
Abstract
An electronic diagnostics device can detect and report environmental conditions from manufacture to use. The device can include a reaction chamber configured to receive a biological sample and contain a reaction with the biological sample. A component of the biological sample can be detected based on the reaction. The device can also include one or more environmental sensors, such as a temperature sensor and a humidity sensor, to detect the environmental conditions. A processor can read data from the environmental sensors and compare the measured conditions to specified ranges. If an environmental parameter falls outside the specified range, the processor can disable the device or communicate to a user that the device should not be used to perform a diagnostic test.
Core Innovation
A self-contained single-use electronic diagnostic device for detecting analytes in biological fluids includes a sample inlet area, a fluidic structure, and a fill sensor for detecting a first volume amount of the sample. The device exits a lower power mode and enters a higher power active mode when the first volume amount is detected, and the device is disabled if the sample is not added within a threshold amount of time after entering the active state. An inlet cover covers and uncovers the sample inlet area, and the device activates processing of the sample when the inlet cover covers the inlet area.
The device further includes a sample reaction area with one or more detection areas comprising dried or lyophilized reagents. A circuit board provides a single LED light source configured to illuminate the one or more detection areas, and one or more optical detectors positioned to receive light reflected from the detection areas, thereby enabling the device to detect one or more analytes. Power is provided by a battery, while a temperature sensor measures temperature and a vacuum package provides a barrier to humidity.
To manage environmental exposure, the device includes a pressure sensor and/or pressure switch configured to detect if the vacuum package is opened in addition to monitoring temperature and, in some implementations, humidity. A microcontroller compares measured temperature and humidity where present with at least one temperature limit and at least one humidity limit where applicable and renders the device unusable if the measured values cross the limits. The temperature sensor and microcontroller monitor the temperature from a time of manufacturing until a time of end-use, and the device operates in the lower power mode during shipment and storage except to periodically measure one or more environmental parameters.
A near field communication circuit communicates a quality assessment of the device with an external device, and the device can also track conditions over time with timer or elapsed time logic tied to expiration or shelf life concepts. The device is configured to disable or render itself unusable based on failure to add sample within a threshold amount of time, and based on exceeding specified environmental limits, including approaches with different limit periods to enable longer shelf life at lower temperatures or lower humidities.
Claims Coverage
The document provides three independent claims, each covering a self-contained single-use electronic diagnostic device with sample-driven power activation and optical analyte detection, coupled with environmental monitoring logic that can disable or render the device unusable.
Sample-driven power activation and conditional disablement
A fill sensor detects a first volume amount of the sample to exit a lower power mode and enter a higher power active mode, and the device is disabled if the sample is not added within a threshold amount of time after the device enters the active state.
Inlet cover-controlled processing activation
An inlet cover covers and uncovers the sample inlet area, and the device is configured to activate processing of the sample when the inlet cover covers the inlet area.
Optical detection with dried or lyophilized reagents
A sample reaction area includes one or more detection areas comprising dried or lyophilized reagents, a single LED light source illuminates the detection areas, and one or more optical detectors receive light reflected from the detection areas to detect one or more analytes.
Vacuum humidity barrier and opened-package detection
A vacuum package provides a barrier to humidity, and a pressure sensor and/or pressure switch detect if the package is opened.
Temperature monitoring from manufacturing to end-use with limit crossing disablement
A microcontroller in data communication with a temperature sensor compares measured temperature with at least one temperature limit and renders the device unusable if the measured temperature crosses the temperature limit, while monitoring temperature from manufacturing until end-use.
Low-power shipment/storage operation with periodic environmental parameter measurement
The device operates in the lower power mode during shipment and storage except to exit the lower power mode periodically to measure one or more environmental parameters.
Near field communication quality assessment with external device
A near field communication circuit communicates a quality assessment of the device with an external device.
Temperature and humidity monitoring with dual-parameter unusable rendering
A microcontroller compares the temperature measured by the temperature sensor with at least one temperature limit and compares the humidity measured by a humidity sensor with at least one humidity limit, and renders the device unusable if the measured temperature crosses the temperature limit or if the measured humidity crosses the humidity limit.
Expiration-time disablement based on elapsed time
A time tracker measures elapsed time from manufacturing of the device to end-use of the device, and a microcontroller disables the device when the elapsed time exceeds an expiration time.
Multi-limit period temperature shelf-life logic
A microcontroller has a time function, compares temperature with at least two temperature limits, and renders the device unusable if the device has exceeded a first temperature limit for a first period of time and if the device has exceeded a second temperature limit for a second period of time, thereby having a longer shelf life at lower temperatures.
Multi-limit period humidity shelf-life logic
The microcontroller compares humidity with at least two humidity limits and renders the device unusable if the device has exceeded a first humidity limit for a first period of time and if the device has exceeded a second humidity limit for a second period of time, thereby having a longer shelf life at lower humidities.
DNA/RNA target detection tied to a genomic sequence
The device is configured to detect DNA or RNA target fragments corresponding to a genomic sequence.
Sample inlet processing workflow including lysing and filtering
Sample preparation includes lysing and filtering the sample prior to detection.
Across the independent claims, the device architecture combines sample-inlet-driven power state changes and inlet-cover processing activation with single-LED optical detection using dried or lyophilized reagents. Environmental monitoring is integrated through temperature and humidity sensing, optional vacuum-package opened detection, and microcontroller logic that can render the device unusable when monitored parameters exceed specified limits, including time-based multi-limit approaches intended to extend shelf life. Near field communication is used to communicate quality assessment with an external device.
Stated Advantages
The device can be disabled or rendered unusable if the sample is not added within a threshold amount of time after the device enters an active state.
The device can prevent use after environmental conditions exceed temperature limits, by rendering the device unusable if monitored temperature crosses the temperature limit.
In some implementations, the device can prevent use after environmental conditions exceed humidity limits, by rendering the device unusable if monitored humidity crosses the humidity limit.
The device can improve shelf life at lower temperatures by using different temperature-limit period logic.
The device can improve shelf life at lower humidities by using different humidity-limit period logic.
The device supports operation in a lower power mode during shipment and storage, with periodic environmental parameter measurement.
A near field communication circuit can communicate a quality assessment of the device with an external device.
Documented Applications
DNA/RNA target detection configured to detect DNA or RNA target fragments corresponding to a genomic sequence.
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