Clinical Decision Support for Nitric Oxide Delivery with Nebulizers

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Solution Overview

Problem

Clinical decision support systems are needed to assist clinicians in safely delivering and monitoring nitric oxide gas therapy, particularly when nebulized drugs are introduced into the breathing circuit, to prevent system damage and ensure accurate dosing.

Innovation Solution

A computer-implemented method providing clinical decision support through a therapeutic gas delivery system, including a nebulizer mode that activates and controls system elements, restricts fluid communication, and displays delivery information using a graphical user interface, with sensors for monitoring and calculating nitric oxide concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If nebulizers are placed further upstream in the inspiratory limb of the breathing circuit to improve drug efficacy, then drug delivery effectiveness is improved, but system elements that may be affected by nebulized drugs are located in substantial proximity or downstream from the nebulizers, increasing the risk of system damage

Engineering Contradiction:

Improvedrug delivery effectivenessVSAvoidrisk of system damage from nebulized drugs

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The system performs preliminary actions by detecting the presence of nebulized drugs in the breathing circuit before they can reach and damage sensitive system elements. The clinical decision support system proactively identifies the risk condition and initiates protective measures, including alerting clinicians and automatically adjusting system operations to prevent damage while maintaining drug delivery effectiveness.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system continuously monitors the breathing circuit for the presence of nebulized drugs and provides real-time feedback to both the control system and clinicians. This feedback mechanism enables dynamic adjustment of system operations based on detected conditions, allowing the system to maintain optimal drug delivery while protecting sensitive components from damage.

Inventive Principle:

Principle #23Feedback

2Measurement precision

If sampling continues during nebulizer operation, then continuous monitoring of therapeutic gas delivery is maintained, but nebulized drugs can interfere with and damage system elements including sensors

Engineering Contradiction:

Improvecontinuous monitoring accuracyVSAvoidsensor damage from nebulized drugs

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system implements periodic sampling rather than continuous sampling during nebulizer operation. By strategically timing sampling events to occur during brief intervals when nebulized drug concentration in the sampling line is minimized, the system maintains adequate monitoring capability while reducing sensor exposure to damaging substances.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The system uses an intermediary approach by implementing a clinical decision support layer that mediates between the need for continuous monitoring and the risk of sensor damage. The support system analyzes multiple data sources and operational parameters to determine optimal sampling timing, balancing monitoring requirements with sensor protection without requiring direct modification of the sensor hardware.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Device complexity

If clinicians manually monitor and manage nebulizer integration with therapeutic gas delivery, then system complexity is reduced, but errors in dosing and system damage risk increase due to lack of integrated control

Engineering Contradiction:

Improvesystem integration complexityVSAvoiddosing accuracy and system safety

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The system implements self-service capabilities by automatically detecting the presence of nebulizers in the breathing circuit, identifying potential conflicts between nebulized drugs and system elements, and autonomously adjusting operational parameters to prevent damage. This automation reduces the burden on clinicians while maintaining high dosing accuracy and system safety through integrated control algorithms.

Inventive Principle:

Principle #25Self-service

Solution Approach 2:

The system replaces manual mechanical monitoring and adjustment processes with automated electronic detection and control mechanisms. Sensors and processors automatically identify nebulizer presence and system conditions, substituting clinician manual intervention with reliable electronic decision support that reduces errors while managing system complexity through software-based solutions.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS11833299B2Clinical decision support system and methods

Publication Date: 2023.12.05 MALLINCKRODT PHARMACEUTICALS IRELAND LTD

AI summary

The present invention provides clinical decision support that can be used with non-portable and portable systems when delivering and/or monitoring delivery of a therapeutic gas comprising nitric oxide to a patient. Further, clinical decision support can be used with non-portable and portable systems during delivery and/or monitoring of delivery of therapeutic gas when nebulized drugs may and/or may not be being delivered to a patient (e.g., when nebulizers are delivered upstream in the inspiratory limb of the breathing circuit, into a breathing gas delivery system, etc.).