Protein Biomarker Panels for SVHD Pulmonary Vascular Risk

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Solution Overview

Problem

There are no validated metrics or biomarkers to reliably identify SVHD patients at risk for pulmonary vascular inadequacy during the interstage period following Stage 1 palliation, leading to complications such as severe hypoxemia and respiratory failure in up to 25% of children undergoing Stage 2 surgical palliation.

Innovation Solution

A method involving obtaining a sample of circulating proteins from subjects with single-ventricle heart disease (SVHD) to test levels of specific protein biomarkers like MMP, TIMP, and FGF, comparing them to a reference range, and identifying subjects at risk for post-operative morbidity by assessing protein levels outside the reference range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If surgical palliation is performed on SVHD patients, then life expectancy is improved, but post-operative complications occur in up to 25% of patients due to undetected pulmonary vascular inadequacy

Engineering Contradiction:

Improvelife expectancyVSAvoidpost-operative complication rate

Core Design Contradiction:

Duration of action of stationary objectVSReliability

Solution Approach 1:

The patent applies preliminary action by measuring protein biomarker levels (MMP, TIMP, FGF) in circulating blood samples before Stage 2 surgical palliation to predict pulmonary vascular adequacy. This pre-operative assessment identifies patients at risk for post-operative complications, allowing for preventive interventions or surgical planning adjustments before the procedure, thereby reducing the 25% complication rate while maintaining improved life expectancy

Inventive Principle:

Principle #10Preliminary action

2Ease of operation

If no biomarkers are used for risk identification, then diagnostic simplicity is maintained, but pulmonary vascular inadequacy cannot be reliably detected leading to severe hypoxemia and respiratory failure

Engineering Contradiction:

Improvediagnostic simplicityVSAvoiddetection accuracy of pulmonary vascular inadequacy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The patent replaces complex invasive diagnostic procedures with a biochemical analysis system that measures protein biomarker levels in circulating blood samples. This substitution maintains ease of operation by using standard laboratory techniques while dramatically improving detection accuracy of pulmonary vascular inadequacy, preventing severe hypoxemia and respiratory failure through reliable pre-operative risk identification

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Measurement precision

If protein biomarker levels are measured and compared to reference ranges, then prediction accuracy of post-operative complications is improved, but diagnostic complexity and testing requirements increase

Engineering Contradiction:

Improveprediction accuracy of complicationsVSAvoiddiagnostic testing complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the complex diagnostic process into distinct measurable components: specific protein biomarkers (MMP, TIMP, FGF) are individually measured in circulating samples and each is compared against established reference ranges. This segmentation transforms a complex diagnostic challenge into manageable, standardized measurements that improve prediction accuracy while maintaining diagnostic clarity through focused biomarker panels

Inventive Principle:

Principle #1Segmentation

Data Source

PatentUS20260063645A1Biomarker compositions, protein panels, devices, and methods to identify risk of and treat pulmonary vascular inadequacy in single ventricle heart disease

Publication Date: 2026.03.05 THE REGENTS OF THE UNIVERSITY OF COLORADO

AI summary

Disclosed herein are methods, compositions and devices for diagnosing pathologic pulmonary vascular disease development, progression, and outcomes from cardiac surgical interventions, particularly surgical palliation in SVHD, and more particularly superior cavopulmonary anastomosis procedures. In particular, methods are provided for assessing risk of post-Stage 2 complications arising from intolerance of Stage 2 physiology due to e.g., pulmonary vascular inadequacy.