ST2 and IL-33 Biomarker Measurement for Mortality Prediction

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Solution Overview

Problem

Clinical evaluation of patients with non-specific symptoms, such as chest pain or dyspnea, often faces challenges in determining the cause and severity of the condition, leading to uncertain treatment decisions, as existing methods lack reliable biomarkers for predicting mortality and severe disease.

Innovation Solution

Measuring serum levels of ST2 and/or IL-33, alone or in combination with other biomarkers, to predict clinical outcomes, detect severe disease, and monitor changes over time, providing diagnostic and prognostic evaluation for patients with non-specific symptoms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If clinical evaluation is based solely on physician assessment for non-specific symptoms, then the evaluation process remains simple and accessible, but the accuracy and reliability of treatment decisions deteriorates

Engineering Contradiction:
Improveaccuracy of treatment decisionsVSAvoidevaluation process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces biomarkers (ST2, IL-33, and other markers) as intermediary substances that mediate between the patient's physiological state and the diagnostic evaluation process. These biomarkers serve as objective mediators that bridge the gap between non-specific symptoms and accurate diagnosis, enabling reliable treatment decisions without requiring complex evaluation procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent utilizes changes in biomarker parameters (concentration levels, ratios, and temporal patterns) to objectively assess disease severity and predict outcomes. By monitoring parameter changes in biomarkers such as ST2 and IL-33, the system transforms subjective clinical assessment into objective, measurable parameters that improve diagnostic accuracy while maintaining evaluation simplicity.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If multiple biomarkers are measured to improve diagnostic accuracy, then the reliability of disease detection improves, but the complexity and cost of testing increases

Engineering Contradiction:
Improvedisease detection accuracyVSAvoidtesting complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the diagnostic evaluation into distinct functional components: screening biomarkers (ST2, IL-33), cardiac-specific biomarkers (troponin, BNP), and other organ-function markers. This segmentation allows systematic addition of tests based on clinical need, improving detection accuracy while managing testing complexity through structured approach.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent combines multiple biomarkers into integrated evaluation panels that work synergistically. By merging ST2, IL-33, troponin, BNP, and other markers into comprehensive panels, the system achieves higher diagnostic accuracy than individual markers alone, while the combination is managed through standardized testing protocols that control complexity.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If biomarker levels are monitored over time to predict outcomes, then the prognostic accuracy improves, but the frequency of testing and time required increases

Engineering Contradiction:
Improveprognostic accuracyVSAvoidtime for repeated testing
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent performs preliminary biomarker measurement at the time of initial presentation to establish a baseline. By conducting preliminary testing for ST2, IL-33, and other markers at admission, the system enables future prognostic assessment without requiring repeated initial testing, thereby reducing time for repeated testing while maintaining prognostic accuracy through serial monitoring of changes.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements feedback mechanisms by monitoring temporal changes in biomarker levels and using this information to dynamically adjust patient management. Serial measurement of biomarkers provides feedback on disease progression or response to treatment, improving prognostic accuracy while the feedback loop is optimized to require testing only when clinically indicated, minimizing time loss.

Inventive Principle:
Principle #23Feedback

Data Source

PatentUS10067146B2Predicting mortality and detecting severe disease
Publication Date: 2018.09.04 CRITICAL CARE DIAGNOSTICS INC
  • US10067146B2 patent drawing
  • US10067146B2 patent drawing
  • US10067146B2 patent drawing

AI summary

Measurement of circulating ST2 and/or IL-33 concentrations is useful for the prognostic evaluation of subjects, in particular for the prediction of adverse clinical outcomes, e.g., mortality, and the detection of severe disease.