Non-Invasive Organ Function Diagnosis via Exhaled Marker Substance

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Solution Overview

Problem

Current methods for non-invasive determination of organ function, such as liver function, are limited by the need for invasive administration of marker substances and are influenced by factors like lung function, with existing tests like LiMAx and ICG tests having limitations in precision and applicability.

Innovation Solution

A method involving inhalation of a marker substance with a vapor pressure above 0.01 mmHg, where the concentration of the substance in exhaled air is measured at different time points to assess metabolization dynamics, providing a non-invasive and lung-condition-reflected assessment of organ function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If marker substances like ICG or methacetin are administered by inhalation, then the non-invasiveness of the test is improved, but the concentration of marker substance achievable in the body is insufficient

Engineering Contradiction:
Improvenon-invasiveness of administrationVSAvoidconcentration of marker substance
Core Design Contradiction:
Ease of operationVSQuantity of substance

Solution Approach 1:

The patent uses a carrier substance (such as ethanol or volatile organic compounds) that can be easily inhaled and serves as a mediator to deliver the marker substance to the target organ. The carrier substance facilitates the transport and delivery of the marker substance, enabling sufficient concentration to be achieved through inhalation without requiring invasive administration methods.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent modifies the physical and chemical parameters of the marker substance by combining it with a carrier substance that has appropriate volatility and solubility characteristics. This parameter change enables the marker substance to be delivered in sufficient concentrations through inhalation, overcoming the limitation of direct inhalation administration.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If the LiMAx test is used to track metabolic product in real time, then information on liver metabolic dynamics is obtained, but the test results are influenced by lung function in patients with altered lung function

Engineering Contradiction:
Improveinformation on liver metabolic dynamicsVSAvoidtest results accuracy in patients with lung diseases
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent extracts and measures the unmetabolized marker substance directly from exhaled air, separating this measurement from the metabolic product measurement. By measuring the marker substance itself rather than its metabolic products, the test eliminates the confounding influence of lung function on the results, as the marker substance concentration in exhaled air directly reflects hepatic metabolism without being affected by respiratory parameters.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses a different marker substance (one that can be inhaled and whose unmetabolized form can be detected in exhaled air) that serves as a copy or alternative to the traditional LiMAx marker. This alternative approach provides the same information about liver metabolic function but through a different measurement pathway that is not influenced by lung function.

Inventive Principle:
Principle #26Copying

3Ease of operation

If ICG test is used to detect clearing of ICG via liver and kidney, then the test is simple to perform, but the function of the kidney and redistribution processes alter the time constant measured

Engineering Contradiction:
Improvesimplicity of testVSAvoidinformation on liver status
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The patent extracts and measures specifically the unmetabolized marker substance from exhaled air, isolating the hepatic metabolism component from other clearance mechanisms. By focusing on the marker substance that is eliminated through breath rather than through kidney clearance or redistribution, the test provides precise information on liver function alone, eliminating the confounding factors present in the ICG test.

Inventive Principle:
Principle #2Taking out (Extraction)

4Quantity of substance

If intravenous administration of marker substance is used, then optimal concentration is achieved, but the invasiveness of the test increases

Engineering Contradiction:
Improveconcentration of marker substanceVSAvoidinvasiveness of administration
Core Design Contradiction:
Quantity of substanceVSEase of operation

Solution Approach 1:

The patent employs a carrier substance that can be inhaled and delivers the marker substance to the bloodstream and target organs through the respiratory system. This intermediary approach enables achieving optimal marker substance concentration without requiring invasive intravenous administration, as the carrier facilitates sufficient delivery through the non-invasive inhalation route.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

This approach allows for precise, non-invasive determination of organ function and disease diagnosis by directly linking the reduction of marker substance concentration in exhaled air to metabolization, offering improved accuracy and applicability, particularly for liver and lung function diagnostics.

Implementation Method 1

a) administering a marker substance to a living organism by inhalation... c) determining the concentration of the marker substance in the exhaled air... d) determining a difference between the concentration of the marker substance determined at the first time point and the concentration of the marker substance determined at the second time point

Methodology Applied
Scientific EffectMetabolization:

Implementation Method 2

wherein the marker substance has a vapor pressure above 0.01 mmHg at 37° C.

Methodology Applied
Scientific EffectVapor pressure: Vapour Pressure

Data Source

PatentUS11103158B2Pure non-invasive method for identification of organ diseases or impaired organ function by investigation of marker substances in exhaled air stimulated by inhaled marker substances
Publication Date: 2021.08.31 FREE UNIV OF BERLIN
  • US11103158B2 patent drawing
  • US11103158B2 patent drawing
  • US11103158B2 patent drawing

AI summary

The disclosure relates to a method for providing original data that can be used for subsequently determining the function of an organ of a living organism or for subsequently diagnosing a disease or a severity of a disease of an organ of a living organism. This method is characterized by several steps, one of which is administering a marker substance to a living organism by inhalation, wherein the marker substance has a vapor pressure above 0.01 mmHg at 37° C. In other method steps, the concentration of this marker substance in exhaled air is determined at at least two different time points. Then, a difference in marker substance concentration is calculated.