Inhaled Nitric Oxide Treatment Stratification for Neonatal Mortality Risk

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Solution Overview

Problem

Current treatments with inhaled nitric oxide for pre-term neonates at risk of bronchopulmonary dysplasia (BPD) pose an increased risk of mortality in white, male pre-term neonates less than 27 weeks gestational age, while non-white and female pre-term neonates of the same age can safely receive the treatment.

Innovation Solution

Identifying and excluding white, male pre-term neonates less than 27 weeks gestational age from inhaled nitric oxide treatment due to their higher risk of mortality, and administering the treatment to non-white and female pre-term neonates, with alternative treatments provided for white, male neonates based on their specific conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If inhaled nitric oxide is administered to pre-term neonates to prevent BPD, then the incidence of BPD is reduced, but mortality risk increases in white male neonates less than 27 weeks gestational age

Engineering Contradiction:
ImproveBPD prevention efficacyVSAvoidmortality risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by differentiating treatment based on specific neonate characteristics (race, sex, gestational age). White male neonates less than 27 weeks gestational age are identified as a distinct subgroup with higher mortality risk and are excluded from treatment, while other neonates receive the beneficial treatment. This targeted approach allows the treatment to be applied locally to appropriate populations rather than universally.

Inventive Principle:
Principle #3Local quality

2Productivity

If inhaled nitric oxide is administered universally to all pre-term neonates at risk of BPD, then BPD prevention is maximized, but overall safety is compromised due to increased mortality in specific subgroups

Engineering Contradiction:
ImproveBPD prevention coverageVSAvoidtreatment safety
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent segments the pre-term neonate population into distinct subgroups based on race, sex, and gestational age characteristics. By dividing the population into those at higher risk (white males less than 27 weeks) and those at lower risk, the treatment can be selectively applied to maximize productivity (BPD prevention coverage) while maintaining reliability (safety) by excluding the high-risk subgroup.

Inventive Principle:
Principle #1Segmentation

3Object-affected harmful factors

If inhaled nitric oxide treatment is restricted to exclude white male neonates less than 27 weeks gestational age, then mortality risk is reduced, but BPD prevention coverage is decreased

Engineering Contradiction:
Improvemortality riskVSAvoidtreatment coverage
Core Design Contradiction:
Object-affected harmful factorsVSProductivity

Solution Approach 1:

The patent converts the harmful effect (increased mortality risk in white male neonates less than 27 weeks) into a beneficial filtering mechanism. By identifying this specific subgroup through demographic criteria, the treatment protocol uses these characteristics to exclude high-risk patients, thereby converting what would be a harmful universal application into a beneficial targeted therapy that protects vulnerable populations while maintaining overall treatment coverage.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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

Reduces the overall risk of mortality from inhaled nitric oxide treatment by tailoring the administration to specific neonatal populations, ensuring safer treatment protocols for pre-term neonates at risk of BPD.

Implementation Method 1

inhaled nitric oxide (a potent and selective pulmonary vasodilator)

Methodology Applied
Scientific EffectVasodilation:

Implementation Method 2

lower pulmonary artery pressure

Methodology Applied
Scientific EffectPulmonary vasodilation:

Data Source

PatentUS20240390634A1Methods of Reducing the Risk of Mortality Associated With a Medical Treatment
Publication Date: 2024.11.28 MALLINCKRODT PHARMACEUTICALS IRELAND LTD

AI summary

Disclosed are methods of treatment that permit a reduction of risk of mortality in infants who are candidates for treatment with inhaled nitric oxide, by identifying a subset of such infants who are at an increased risk of mortality upon treatment with inhaled nitric oxide; also disclosed are related systems for use in administering inhaled nitric oxide and methods of distributing a pharmaceutical product.