Automated CCHD Screening Using Inter-Site SpO2 Gradients

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Solution Overview

Problem

Current pulse oximetry screening for critical congenital heart defects (CCHDs) in newborns is prone to false positives and may miss defects, leading to unnecessary and costly diagnostic echocardiograms, and existing systems face challenges in accurately detecting CCHDs due to variability in oxygen saturation measurements.

Innovation Solution

A system utilizing a single or dual sensor pulse oximeter with a processor that executes instructions for noninvasive measurement and analysis, including configurable confidence thresholds and data processing to improve measurement accuracy and reduce errors, facilitating automated CCHD screening and detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pulse oximetry screening is used to detect CCHDs, then screening coverage is improved, but false positives increase leading to unnecessary diagnostic procedures

Engineering Contradiction:
ImproveCCHD detection accuracyVSAvoidfalse positives
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent segments the CCHD screening process into multiple independent measurement sites (pre-ductal and post-ductal locations) and compares results across sites. This segmentation allows the system to identify true CCHD cases through inter-site differences while filtering out false positives that affect all sites uniformly, thereby improving detection accuracy without increasing unnecessary diagnostics

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent changes the screening parameter from single-site absolute oxygen saturation to inter-site oxygen saturation differences (gradients). By measuring and comparing SpO2 values across multiple anatomical sites and analyzing the gradient between them, the system achieves better differentiation between true CCHD cases and false positives, reducing unnecessary diagnostic procedures

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If multiple measurement sites are used to improve CCHD detection accuracy, then measurement reliability is improved, but device complexity increases

Engineering Contradiction:
Improveoxygen saturation measurement accuracyVSAvoidscreening system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent makes a single pulse oximeter device multi-functional by enabling it to perform measurements at multiple measurement sites through sequential placement. The device maintains its basic single-site measurement capability while adding the ability to compare results across sites, achieving improved measurement precision without requiring multiple separate devices or complex specialized equipment

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Productivity

If automated screening systems are implemented, then screening efficiency is improved, but false positive rates increase

Engineering Contradiction:
Improvescreening throughputVSAvoidfalse positive rate
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent implements feedback mechanisms where measurement results from one site inform the interpretation of subsequent measurements. The system uses inter-site gradient information as feedback to adjust screening decisions, allowing automated systems to maintain high throughput while reducing false positives through comparative analysis that provides contextual feedback on measurement validity

Inventive Principle:
Principle #23Feedback

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

The system enhances the accuracy of CCHD screening by reducing false positives and improving measurement reliability, allowing for more efficient and cost-effective detection of CCHDs, thereby minimizing unnecessary diagnostic procedures.

Implementation Method 1

Pulse oximetry screening can identify some critical congenital heart defects

Methodology Applied
Scientific EffectLight absorption: Absorption (EM radiation)

Data Source

PatentUS20240293087A1Automated condition screening and detection
Publication Date: 2024.09.05 MASIMO CORP
  • US20240293087A1 patent drawing
  • US20240293087A1 patent drawing
  • US20240293087A1 patent drawing

AI summary

Embodiments are disclosed that enable an electronic device to instruct as user how to user one or more noninvasive sensors to measure one or more physiological parameters of a patient. In one embodiment, the measured parameters are used to obtain a diagnosis, such as a diagnosis of a critical congenital heart defect.