Exhaled Nitric Oxide Sensing for Reliable Sepsis Risk Scoring

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Solution Overview

Problem

Current methods for diagnosing sepsis are invasive, unreliable, and often result in false positives or negatives due to the instability of nitric oxide in blood and environmental factors affecting exhaled breath NO concentrations, leading to inadequate sepsis detection and risk assessment.

Innovation Solution

A non-invasive method and device that measures nitric oxide concentrations in exhaled breath at a controlled rate, combined with vital statistics, to determine a sepsis risk score, using electrochemical or spectroscopic sensing, and optionally incorporating additional patient measurements for enhanced accuracy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If blood samples are used to measure nitric oxide concentrations, then sepsis detection sensitivity is improved, but measurement reliability deteriorates due to NO instability in blood

Engineering Contradiction:
Improvesepsis detection sensitivityVSAvoidmeasurement reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent uses exhaled breath as an intermediary medium to indirectly measure nitric oxide concentrations that reflect endothelial dysfunction and sepsis risk. Instead of directly measuring unstable NO in blood, the system measures NO in exhaled breath, which serves as a stable proxy indicator. This intermediary approach maintains detection sensitivity while improving measurement reliability by avoiding the instability problem of blood-based NO measurement.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If exhaled breath NO measurement is performed without controlled exhalation rate, then ease of operation is improved, but measurement precision deteriorates due to environmental factors

Engineering Contradiction:
Improvebreath collection simplicityVSAvoidNO concentration accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The system dynamically adjusts and controls the exhalation rate during breath collection to optimize measurement conditions. By implementing controlled exhalation rate management, the system maintains ease of operation while improving measurement precision, as the controlled rate minimizes the influence of environmental factors on NO concentration readings.

Inventive Principle:
Principle #15Dynamics

3Productivity

If rapid sepsis diagnosis methods like qSOFA are used, then productivity is improved, but reliability deteriorates due to false positives and negatives

Engineering Contradiction:
Improvediagnosis speedVSAvoiddiagnosis accuracy
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent replaces subjective clinical assessment methods (mechanical/physical evaluation) with an automated analytical system that measures nitric oxide concentrations. This substitution maintains the rapid diagnosis capability of bedside testing while improving reliability through objective, quantifiable measurements that reduce false positives and negatives associated with traditional scoring systems.

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

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

Provides a fast, reliable, and non-invasive means to assess sepsis risk and monitor condition changes, reducing false positives/negatives, and enabling early intervention.

Implementation Method 1

determining a NO concentration in the exhaled breath sample... using electrochemical or spectroscopic sensing

Methodology Applied
Scientific EffectElectrochemical sensing:

Implementation Method 2

determining a NO concentration in the exhaled breath sample... using electrochemical or spectroscopic sensing

Methodology Applied
Scientific EffectSpectroscopic sensing:

Data Source

PatentUS12539073B1Apparatus and method for the determination of endothelial dysfunction and sepsis risk using nitric oxide concentrations in exhaled breath
Publication Date: 2026.02.03 VAIL SCI LLC
  • US12539073B1 patent drawing
  • US12539073B1 patent drawing
  • US12539073B1 patent drawing

AI summary

A method for determining a risk of sepsis in a patient is disclosed. The method includes collecting an exhaled breath sample, determining a NO concentration in the exhaled breath sample; and determining a sepsis risk score correlated to the NO concentration, wherein the sepsis risk score is indicative of a risk of a patient having or developing sepsis. The method may further include determining an additional measurement of the patient's vital statistics including one or more of: end tidal CO2, respiratory rate, pulse rate, body temperature, cognitive assessment score, systolic blood pressure, diastolic blood pressure, or hemoglobin oxygen saturation level, and further determining the sepsis risk score based on the additional measurement.