Dual-Label Meal for Digestive Health Assessment

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Solution Overview

Problem

Current tests for digestive and metabolic disorders are highly specific and limited to evaluating single compartments, requiring multiple tests to assess overall digestive and metabolic health, and cannot determine if disorders occur within the stomach or beyond.

Innovation Solution

A method involving a breath test with labels incorporated into proteins, carbohydrates, and lipids, along with scintigraphy, to assess gastric emptying and overall digestive health, allowing for a comprehensive evaluation of digestive functions across multiple compartments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple specific tests are used to evaluate single compartments, then measurement precision for specific disorders is improved, but device complexity and loss of time increase due to requiring multiple separate tests

Engineering Contradiction:

Improveprecision for evaluating specific digestive compartmentsVSAvoidnumber of tests required

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The breath test uses a dual-labeled meal containing both 13C-labeled substrates (for metabolic evaluation) and 99mTc-labeled substrates (for gastric emptying assessment). This single test simultaneously evaluates multiple digestive compartments including stomach, small intestine, liver, and lungs, making the test universal for assessing overall digestive health rather than requiring multiple separate compartment-specific tests

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The patent combines two different labeling systems (13C stable isotope labeling for breath analysis and 99mTc radioactive labeling for scintigraphy) into a single dual-labeled meal. This merging allows concurrent measurement of both metabolic parameters and gastric emptying rates in one test, reducing the number of separate tests needed

Inventive Principle:

Principle #5Merging (Combining)

2Measurement precision

If multiple separate tests are administered to assess overall digestive health, then measurement precision is improved, but loss of time increases

Engineering Contradiction:

Improvecomprehensive assessment of digestive healthVSAvoidtime required for testing

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

The dual-labeled meal allows continuous monitoring of digestive processes from ingestion through absorption and metabolism. The breath test can be performed continuously over time points, and the scintigraphy provides continuous imaging of gastric emptying, eliminating the need for multiple discrete test administrations and reducing total testing time

Inventive Principle:

Principle #20Continuity of useful action

3Adaptability or versatility

If breath test uses labels incorporated into proteins, carbohydrates, and lipids, then adaptability for overall digestive health assessment is improved, but measurement precision for specific compartments becomes more difficult to detect

Engineering Contradiction:

Improveability to assess overall digestive healthVSAvoiddetection of specific compartment disorders

Core Design Contradiction:

Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

The dual-labeling system provides local quality differentiation: the 13C label tracks metabolic processing through breath analysis while the 99mTc label specifically tracks gastric emptying through scintigraphy. This allows the test to maintain versatility for overall assessment while providing specific compartment detection capabilities through the radioactive label's localized imaging

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

Enables a simple, comprehensive assessment of overall digestive health by measuring the digestion, absorption, and metabolism of these food elements across various compartments, identifying disorders within the stomach or beyond, and monitoring treatment effectiveness.

Implementation Method 1

a labeled component, such as 13CO2, is produced which can be detected in the patient's breath

Methodology Applied

Scientific EffectRespiratory exhalation:

Implementation Method 2

The gamma emission from the radiolabel is measured by a scintillation camera as the labeled food is emptied from the stomach

Methodology Applied

Scientific EffectGamma emission:

Implementation Method 3

a scintigraphy test... The gamma emission from the radiolabel is measured by a scintillation camera

Methodology Applied

Scientific EffectScintillation: Scintillation

Data Source

PatentUS8317718B2Methods of testing digestive functions using both a breath test and a scintigraphy test, and methods of using a breath test as an overall digestive health assessment

Publication Date: 2012.11.27 ADVANCED BREATH DIAGNOSTICS LLC

AI summary

Methods for assessing an overall digestive health of a patient are provided, which include administering a breath test that uses a label incorporated into proteins, carbohydrates, and lipids and further incorporating the labeled material into a meal which, when cooked, facilitates the binding of the label material to the solid phase matrix of the meal. Methods for assessing digestive functions of a patient are also provided, which includes concurrently administering a breath test and a scintigraphy test that measure gastric emptying in a stomach.