Syncope Detection and Classification via Hemodynamic Impedance Analysis

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Solution Overview

Problem

Current ambulatory monitors for syncope detection, such as implantable loop recorders, are inadequate for diagnosing non-cardiac causes of syncope, like neurally mediated and orthostatic syncope, due to limited resource constraints and low symptom-ECG correlation, leading to inadequate differential diagnosis and increased medical costs.

Innovation Solution

A patient monitor system that includes a physiological event detector circuit, a hemodynamic sensor circuit, and a syncope analyzer circuit to detect and classify syncope events into cardiogenic, orthostatic, or neurally mediated types by analyzing hemodynamic data triggered by a precipitating event, improving sensitivity and specificity of syncope detection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If implantable loop recorders are used for syncope detection, then syncope events can be monitored in ambulatory settings, but the ability to diagnose non-cardiac causes of syncope is inadequate due to limited resource constraints and low symptom-ECG correlation

Engineering Contradiction:
Improvesyncope detection capabilityVSAvoiddifferential diagnosis capability
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The monitor is enhanced to perform multiple functions: it detects both cardiogenic and non-cardiogenic syncope by analyzing multiple physiological parameters including ECG, impedance, and activity data. The system classifies syncopal events into different categories (cardiogenic, orthostatic, neurally mediated) making it versatile for diagnosing various causes of syncope, not limited to cardiac causes only

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

Solution Approach 2:

The system changes from monitoring only ECG parameters to monitoring multiple physiological parameters simultaneously. By analyzing impedance changes, heart rate variability, and activity levels in combination with ECG data, the system can differentiate between cardiogenic and non-cardiogenic causes of syncope, improving diagnostic accuracy

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If traditional ECG-based monitoring is used, then cardiogenic syncope can be detected, but non-cardiac causes of syncope cannot be adequately diagnosed

Engineering Contradiction:
Improvecardiogenic syncope detection accuracyVSAvoidhemodynamic information
Core Design Contradiction:
Measurement precisionVSLoss of information

Solution Approach 1:

The system uses impedance measurements as an intermediary parameter to infer hemodynamic changes. By measuring electrical impedance across the chest, the system can detect blood volume changes and cardiac output variations that indicate orthostatic or neurally mediated syncope, providing indirect hemodynamic information without direct blood pressure measurement

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The monitoring system segments the analysis into multiple independent parameter streams (ECG, impedance, activity) that are analyzed separately and then integrated. This segmentation allows the system to preserve ECG information for cardiogenic detection while simultaneously extracting hemodynamic information from impedance changes for non-cardiogenic syncope diagnosis

Inventive Principle:
Principle #1Segmentation

3Measurement precision

If comprehensive hemodynamic monitoring is implemented, then syncope classification accuracy improves, but device complexity and resource consumption increase

Engineering Contradiction:
Improvesyncope classification accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system merges multiple sensing functions into a single integrated monitor device. The ECG electrodes also serve as impedance sensing electrodes, and the same processor analyzes all physiological parameters. This merging reduces device complexity compared to having separate devices for ECG monitoring and hemodynamic monitoring

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentUS10849568B2Systems and methods for syncope detection and classification
Publication Date: 2020.12.01 CARDIAC PACEMAKERS INC
  • US10849568B2 patent drawing
  • US10849568B2 patent drawing
  • US10849568B2 patent drawing

AI summary

Systems and methods for monitoring patient for syncope are discussed. A syncope monitor system can detect a precipitating event associated with a syncope onset, and acquire hemodynamic data in response to the detection of the precipitating event. A syncope analyzer circuit may generate temporal profiles of one or more hemodynamic parameters using the hemodynamic data. The syncope analyzer may use the temporal profiles to detect a syncopal event and to classify the syncopal event into one of a plurality of syncope categories. The detection and classification information may be output to a user or a process.