Single-Use Chemical Diagnostics With Environmental Self-Verification
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Solution Overview
Problem
Existing point-of-care diagnostic devices lack the ability to monitor environmental conditions during shipping and storage, which can compromise their performance, especially for devices using biological molecules, and they often require complex sample collection and analysis in centralized laboratories, leading to high costs and delays in patient treatment.
Innovation Solution
A self-contained electronic diagnostic device with integrated environmental sensors (temperature, humidity, and pressure) that monitors conditions from manufacturing to use, disabling the device if parameters fall outside specified ranges, and includes a processor to manage sample preparation and digital readout, enabling communication of results to consumer electronics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If point-of-care diagnostic devices are made self-contained and disposable, then ease of operation and cost are improved, but the ability to monitor environmental conditions during shipping and storage is lost, compromising device reliability
Solution Approach 1:
Environmental sensors are integrated into the device before use to continuously monitor temperature, humidity, and other conditions from manufacturing through shipping to the point of care. This preliminary monitoring ensures that environmental factors are tracked in advance, preventing degradation of reagents and maintaining device reliability without complicating the user interface.
Solution Approach 2:
The device performs self-verification by automatically checking environmental conditions and comparing them against acceptable ranges. The processor evaluates sensor data and determines whether the device has been exposed to conditions that would compromise performance, enabling the device to self-assess its own reliability without requiring external laboratory verification.
2Reliability
If environmental monitoring is added to point-of-care devices, then device reliability is improved, but device complexity increases
Solution Approach 1:
The processor serves multiple functions: it controls the diagnostic testing, processes sensor signals from environmental sensors, evaluates environmental conditions, and determines device usability. By making the processor multi-functional, the patent avoids adding separate dedicated circuits for each function, thereby maintaining simplicity while achieving comprehensive environmental monitoring and reliability assessment.
Solution Approach 2:
Multiple functional components are merged into a single integrated device: the diagnostic testing reagents, environmental sensors (temperature, humidity, pressure), processor, and sample analysis components are combined in one self-contained unit. This merging eliminates the need for separate monitoring devices and simplifies the overall system architecture while ensuring reliable operation.
3Measurement precision
If centralized laboratory analysis is used, then measurement precision is improved, but loss of time and productivity decrease
Solution Approach 1:
The device pre-loads reagents and calibration data into the self-contained unit during manufacturing, so that when the device is used at the point of care, all necessary components for accurate measurement are already in place. This preliminary preparation eliminates the need for time-consuming sample transport and laboratory setup, enabling immediate accurate testing.
Solution Approach 2:
The environmental sensors and processor act as intermediaries that verify and ensure the accuracy of the diagnostic test by confirming that environmental conditions have remained within acceptable ranges throughout the device's lifecycle. This intermediary verification system maintains measurement precision without requiring centralized laboratory oversight.
Data Source
AI summary
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.