Breath Test System for Gastrointestinal Diagnosis
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Solution Overview
Problem
Current methods for diagnosing gastric and gastrointestinal disorders, such as dyspepsia and Irritable Bowel Syndrome, are invasive, uncomfortable, and impractical for wide clinical use, often providing inaccurate results and limited to determining distension and filling disorders, necessitating a simpler, quicker, and more reliable diagnostic approach.
Innovation Solution
The development of automated breath test procedures that allow for real-time diagnosis of gastrointestinal conditions, including dyspepsia and IBS, using multiple breath tests to assess gastric emptying, accommodation, and bacterial overgrowth, with micro-encapsulated isotopic markers to determine the passage of meals through the duodenum and colon, enabling precise treatment management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If barostat studies are used to measure gastric accommodation and distention, then measurement precision is improved, but ease of operation deteriorates due to invasive procedures and patient discomfort
Solution Approach 1:
The patent replaces the mechanical barostat system with a breath test system that uses chemical markers (13C-labeled compounds) and gas analysis to assess gastric emptying and accommodation. This substitution eliminates the need for invasive intragastric balloons and complex pressure control mechanisms, providing accurate measurements through non-invasive breath sampling and isotopic analysis.
2Measurement precision
If barostat procedures are used to diagnose gastric disorders, then measurement precision is improved, but device complexity increases due to computer-controlled pumps and pressure monitoring systems
Solution Approach 1:
The complex mechanical barostat system with computer-controlled pumps and pressure sensors is replaced by a simplified breath test system. The new system uses oral administration of 13C-labeled substrates, standard breath collection bags, and gas chromatography or mass spectrometry for isotopic analysis, dramatically reducing device complexity while maintaining diagnostic accuracy.
Solution Approach 2:
The patent introduces 13C-labeled chemical markers as intermediaries to indirectly measure gastric emptying and accommodation. These markers are incorporated into test meals, pass through the gastrointestinal tract, and are detected in breath samples, serving as mediators that simplify the measurement process compared to direct mechanical volume and pressure monitoring.
3Measurement precision
If multiple separate tests are performed to diagnose different GI conditions, then measurement precision for each condition is improved, but loss of time increases due to sequential testing
Solution Approach 1:
The patent merges multiple diagnostic functions into a single integrated breath test system. By using 13C-labeled substrates with different metabolic pathways and detection methods, the system can simultaneously assess gastric emptying, small intestinal transit, colonic transit, and bacterial overgrowth in one unified protocol, eliminating the need for multiple separate tests and reducing total diagnostic time.
Solution Approach 2:
The breath test system is designed with universal applicability to diagnose multiple gastrointestinal disorders. The same basic platform—oral substrate administration, breath collection, and isotopic analysis—can evaluate different physiological functions by changing the 13C-labeled substrate type, enabling one system to perform multiple diagnostic roles that previously required separate specialized tests.
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
These methods provide accurate, non-invasive, and easily tolerable diagnostics for various gastrointestinal disorders, enabling precise treatment prescription and management of symptoms, improving patient care by offering quick and reliable results.
Implementation Method 1
the properties of the micro-encapsulation coating material are chosen such that the isotopically labeled material is released in the predetermined part of the gastro-intestinal tract
Implementation Method 2
administering to the subject a test meal comprising a labeled marker whose by-products are absorbed and exhaled in breaths of the subject after exit from the stomach
Data Source
AI summary
Methods of determining gastro-intestinal conditions by performing a succession of breath tests or others tests, particularly for determining the gastric emptying or gastric accomodation condition of a subject. Methods of performing successive gastric emptying tests with different test meals are also presented, enabling the gastric accommodation to be determined. The effects of different test means on the results is presented. Novel substrates for use in such tests are suggested, including the use of micro-encapsulation. Breath tests for the detection of bacterial overgrowth, lactose intolerance and combinations thereof are presented.