Breath Analysis System With CO2 Validation and Flexible Bag
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Solution Overview
Problem
Current breath analysis systems face challenges in ensuring the accuracy and reliability of breath sample collection, often resulting in invalid samples due to improper collection techniques or equipment limitations, which can lead to false positives or negatives in disease diagnosis.
Innovation Solution
A breath collection system featuring a flexible bag with a valve device that opens when the patient bites on a teeth receptacle area, a mouth flange to prevent external airflow, and a microreactor cassette for processing the breath sample, coupled with a CO2 sensor for real-time validation of sample quality, ensuring that only valid breath samples are analyzed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a traditional open breath collection method is used, then the collection process is simple, but the sample accuracy deteriorates due to contamination from external airflow and improper collection techniques
Solution Approach 1:
The patent employs a flexible bag made of permeable material to collect breath samples. The flexible nature of the bag allows it to conform to the patient's breath while the permeable material enables selective gas exchange, improving sample accuracy without requiring a rigid complex structure
Solution Approach 2:
The valve device acts as an intermediary between the patient's mouth and the collection bag. It controls and regulates the breath flow, allowing only proper breath samples to enter the bag while preventing contamination from external airflow, thus improving sample accuracy
2Reliability
If no validation mechanism is implemented, then the system is simpler, but the reliability deteriorates due to false positives or negatives from invalid samples
Solution Approach 1:
The system incorporates a CO2 sensor that provides real-time feedback on breath sample quality. The sensor validates whether the collected breath contains sufficient CO2 levels to be considered a valid alveolar breath sample, ensuring diagnostic reliability by filtering out invalid samples before analysis
Solution Approach 2:
The patent replaces manual validation of breath samples with an automated CO2 sensing system. This substitution of mechanical/chemical sensing for human judgment improves reliability by objectively detecting CO2 concentrations to validate sample quality
3Productivity
If the valve remains closed during collection, then external contamination is prevented, but the productivity deteriorates due to inability to collect breath samples
Solution Approach 1:
The valve device transitions from a static closed state to a dynamic state that opens in response to patient biting on the teeth receptacle area. This dynamic behavior allows the system to maintain protection against external contamination while enabling efficient breath collection when needed
Solution Approach 2:
The valve device is designed to open automatically when the patient bites on the teeth receptacle area, eliminating the need for external activation. The system serves itself by using the patient's natural action to trigger the valve opening, improving collection efficiency
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 system significantly increases the percentage of valid breath samples collected, allowing for reliable detection of volatile organic compounds and other gases, thereby improving the accuracy and reliability of breath diagnostic analysis and enabling early disease detection.
Implementation Method 1
The bag may be formed of material that is permeable to water vapor, but is not permeable to volatile organic compounds
Data Source
AI summary
A system determines if a breath sample is valid or invalid for subsequent diagnostic analysis. The system includes a breath collection device configured to contain a collected patient breath sample. A cassette has reagents therein and is configured to fluidly couple with the breath collection device and the validity analysis device. A validity analysis device has a fluidic pathway and a controller. The validity analysis device is configured to fluidly couple with the cassette and/or the breath collection device. The analysis device is further configured to evacuate at least a portion of the patient breath sample from the breath collection device, such that the patient breath sample passes through the cassette to define a processed gas sample. A CO2 sensor is configured to determine a CO2 concentration in the processed gas sample. The controller is configured to determine when a patient provided an invalid collected patient breath sample.