13C Breath Gas Test for Gastrointestinal Emptying Assessment

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Solution Overview

Problem

Current 13C breath gas tests are inadequate for assessing gastrointestinal function in sick and critically ill patients due to irregular release curves and the inability to separate gastric emptying and metabolic processes, leading to unreliable results and complexity in evaluation.

Innovation Solution

A 13C breath gas test method involving the administration of a 13C-labelled compound, with differential equations to model the kinetics of the compound's transfer in the body, using a transfer function to describe gastric emptying and metabolism, and regularization to optimize polynomial coefficients for accurate data interpretation, allowing for automated evaluation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If 13C breath gas tests are used to assess gastrointestinal function in sick patients, then metabolic information can be obtained, but the irregular release curves and inability to separate gastric emptying from metabolism lead to unreliable results

Engineering Contradiction:
Improvereliability of gastrointestinal function assessmentVSAvoidaccuracy of test results in critically ill patients
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention segments the mixed 13CO2 release signal into distinct components: gastric emptying phase and metabolic oxidation phase. By applying mathematical deconvolution with a transfer function R(t), the method separates these overlapping processes, allowing independent quantification of each. This segmentation resolves the fundamental problem of being unable to distinguish gastric emptying from metabolism in breath test data from critically ill patients.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention changes the parameter representation by introducing the transfer function R(t) with polynomial coefficients that are optimized through regularization. This transforms the uninterpretable irregular release curves into quantifiable parameters (area under the curve, time to peak, half-maximal time) that reliably characterize gastric emptying kinetics even in pathological conditions, thereby improving measurement precision.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If comprehensive data collection is performed to accurately assess gastrointestinal function, then reliable results can be obtained, but the evaluation process becomes complex and time-consuming

Engineering Contradiction:
Improveaccuracy of gastrointestinal function measurementVSAvoidcomplexity of data evaluation process
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The evaluation method is fully automated and performs self-service by automatically fitting the transfer function to the measured 13CO2 release data using regularization techniques. The system independently determines the polynomial coefficients and calculates all relevant parameters without requiring manual intervention or complex manual analysis, thereby simplifying the evaluation process while maintaining high measurement precision.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The invention replaces complex manual evaluation mechanics with automated mathematical computation. Instead of requiring experts to manually analyze irregular release curves, the system uses computer-based optimization algorithms with regularization to automatically extract meaningful parameters, significantly reducing evaluation complexity and enabling routine clinical use.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If 13C breath gas tests are performed on critically ill patients, then gastrointestinal function can be assessed, but the irregular release curves make data interpretation difficult and unreliable

Engineering Contradiction:
Improveapplicability to critically ill patientsVSAvoidinterpretability of release curve data
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The invention introduces dynamic flexibility through the polynomial-based transfer function R(t) with optimized coefficients. This dynamic model can adapt to various release curve shapes including irregular, multiphase patterns characteristic of critically ill patients. The regularization process dynamically adjusts the polynomial coefficients to best fit the measured data, enabling accurate interpretation of previously uninterpretable irregular curves.

Inventive Principle:
Principle #15Dynamics

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

Enables reliable determination of gastrointestinal emptying and metabolism in critically ill patients, providing objective and reproducible results without the need for extensive data collection, simplifying the evaluation process and making it suitable for routine use.

Implementation Method 1

determining the change in the relative concentrations of the 13C-labeled metabolite in the exhaled air of the patient immediately after administration of the test compound

Methodology Applied
Scientific EffectIsotope-specific analysis: Absorption Spectroscopy

Data Source

PatentEP3220818B113c breath test for checking the gastrointestinal function and/or metabolic functions and device therefor
Publication Date: 2019.08.21 FISCHER ANALYZEN INSTR
  • EP3220818B1 patent drawingFigure 1(a)~1(c)
  • EP3220818B1 patent drawingFigure 2
  • EP3220818B1 patent drawingFigure 3

AI summary

The invention relates to a 13C breath test for checking the gastrointestinal function and/or the metabolic functions in the case of a patient, comprising the following steps: administering a compound marked with 13C to a patient, by which patient the 13C-marked compound is converted into a 13C-marked metabolism product, wherein the 13C-marked metabolism product is 13CO2; determining the change in the relative concentrations of 13CO2 in the breathing air of the patient over a predetermined time interval in the form of enrichment data; and evaluating the obtained enrichment data on the basis of a mathematical estimate of the 13C release curve; and back-calculating the gastrointestinal emptying in the form of the transfer function R(t) from the obtained polynomial coefficients and determining the metabolism of the 13C-marked compound into 13CO2 from the metabolism parameter (γ). The 13C breath test can be performed in a non-invasive, non-radioactive, safe, simple, and effective manner and provides information about the gastrointestinal emptying and/or metabolic function within minutes.