Breath Collection Apparatus for Volatile Biomarker Segmentation

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Solution Overview

Problem

Current human breath analysis technologies for disease diagnosis are hindered by inadequate reproducibility, sensitivity, selectivity, unreliable sample collection, and high costs, limiting their adoption in clinical practice despite the potential of volatile biomarkers for non-invasive disease assessment.

Innovation Solution

A portable microprocessor-controlled breath collection apparatus that collects pre-specified fractions of exhaled air into sorbent tubes for analysis using Gas Chromatography and Mass Spectrometry techniques, specifically employing Field Asymmetric Ion Mobility Spectrometry to detect volatile biomarkers for disease diagnosis, while ensuring reproducibility, selectivity, and cost-effectiveness.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If classical chemical analytical instruments are used for volatile biomarker detection, then measurement precision can be achieved, but device complexity and cost increase significantly

Engineering Contradiction:
Improvedetection precisionVSAvoiddevice complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system segments the breath analysis process into distinct phases (inspiration, pause, expiration) and collects samples at specific segments. The breath collection device divides the sampling process into multiple discrete time segments, allowing simplified detection at each segment while maintaining overall measurement precision through cumulative data from segmented samples.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary actions by having the patient complete specific breathing maneuvers (deep inhalation, breath hold, controlled exhalation) before the actual analysis. This preliminary breath preparation ensures that volatile biomarkers are concentrated and properly positioned in the breath sample, enabling more sensitive detection with simpler instruments.

Inventive Principle:
Principle #10Preliminary action

2Measurement precision

If volatile biomarkers are detected at ppb-ppt concentration levels, then measurement precision improves, but technology sensitivity requirements increase

Engineering Contradiction:
Improvedetection precisionVSAvoiddetection difficulty
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The system performs preliminary concentration of volatile biomarkers by having patients perform breath holds and controlled exhalations. This preliminary action allows biomarkers to accumulate to detectable levels before analysis, reducing the sensitivity burden on the detection instrument while maintaining ppb-ppt level measurement precision.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system introduces an intermediary sampling and preparation stage between the patient's breath and the detector. The breath collection device with its controlled flow path and sampling chambers acts as an intermediary that concentrates and conditions the breath sample, making ppb-ppt level biomarkers more detectable by subsequent analytical instruments.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If multiple volatile biomarker compounds are detected simultaneously, then measurement precision increases, but selectivity requirements increase

Engineering Contradiction:
Improvedetection precisionVSAvoidselectivity
Core Design Contradiction:
Measurement precisionVSDifficulty of detecting and measuring

Solution Approach 1:

The system segments the complex breath analysis into multiple targeted detection steps. Instead of attempting to detect all volatile compounds simultaneously, the system divides the analysis into separate detection phases for different biomarker groups, improving selectivity for each target while maintaining overall measurement precision through cumulative results.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system applies local quality by optimizing detection parameters and sampling conditions for specific target compounds at different stages. Different portions of the breath sample are analyzed with different detection settings tailored to specific biomarker types, enhancing selectivity for each compound group while maintaining comprehensive detection precision.

Inventive Principle:
Principle #3Local quality

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 apparatus provides highly accurate, economical, and non-invasive collection and analysis of breath volatile biomarkers, enabling reliable diagnostic and prognostic assessments for inflammatory, infectious, and neoplastic diseases like lung cancer, with improved reproducibility and sensitivity.

Implementation Method 1

a portable microprocessor-controlled breath collection apparatus collects pre-specified fractions of exhaled air into sorbent tubes

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 2

analysis using Gas Chromatography and Mass Spectrometry techniques

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 3

Mass Spectrometry techniques, specifically employing Field Asymmetric Ion Mobility Spectrometry

Methodology Applied
Scientific EffectIonization: Ionisation

Implementation Method 4

Field Asymmetric Ion Mobility Spectrometry to detect volatile biomarkers

Methodology Applied
Scientific EffectIon mobility: Electrophoresis

Data Source

PatentEP3448256B1Systems and device for capturing breath samples
Publication Date: 2023.09.20 OWLSTONE MEDICAL LTD
  • EP3448256B1 patent drawingFigure 1~2
  • EP3448256B1 patent drawingFigure 3
  • EP3448256B1 patent drawingFigure 4

AI summary

There is provided a device (10) for collecting a breath portion from a patient for analysis, comprising a housing structure including an inlet port (30) associated with a mask structure for receiving a portion of the patient's breath, at least one sensor (22) operatively coupled to the inlet port (30) for detecting one or more parameters regarding the patient's breath, at least one collection container (20) for collecting a portion of the patient's breath received in the inlet port (30), at least one pump (28) for pumping a selective portion of the patient's breath from the inlet port (30) to the at least one collection container (20) and a control system (32) for controlling operation of the at least one sensor and at least one pump (30). The control system (32) selectively operates the pump based on sensed parameters such as CO2 and/or pressure to collect breath samples.