Implantable ECG Monitor for Stroke Detection via Questionnaire Verification

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Solution Overview

Problem

Current methods for detecting strokes in patients with implantable medical devices are inadequate for timely and accurate identification, as they often rely solely on electrocardiac signal changes that can also occur due to cardiac ischemia, leading to potential misdiagnosis and delayed medical intervention.

Innovation Solution

An implantable medical device that senses electrocardiac signals to detect stroke indicators such as prominent U-waves, notched T-waves, changes in ST segment duration, and QT duration, and uses a subcutaneous ECG-based monitor system in conjunction with an external bedside monitor to generate a questionnaire for family or caregivers to confirm the stroke, allowing for prompt notification of emergency personnel.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If stroke detection is based solely on electrocardiac signal changes, then detection speed is improved, but diagnostic accuracy deteriorates due to potential misdiagnosis from cardiac ischemia

Engineering Contradiction:
Improvedetection speedVSAvoiddiagnostic accuracy
Core Design Contradiction:
Loss of timeVSMeasurement precision

Solution Approach 1:

The detection system is segmented into multiple independent components: ECG signal analysis, questionnaire assessment, and automated notification systems. Each component operates semi-independently to provide comprehensive stroke detection while reducing reliance on any single method, thereby maintaining detection speed while improving diagnostic accuracy through multi-modal verification.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A questionnaire is introduced as an intermediary tool between ECG signal detection and final diagnosis. The questionnaire assesses neurological symptoms (speech, vision, motor function) to verify stroke suspicion, acting as a mediator that filters false positives from cardiac ischemia while maintaining rapid detection through automated delivery and interpretation.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Measurement precision

If a comprehensive questionnaire is administered to confirm stroke, then diagnostic accuracy is improved, but time for medical intervention increases

Engineering Contradiction:
Improvediagnostic accuracyVSAvoidtime for medical intervention
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs self-service by automatically delivering the questionnaire through the implantable device or external monitor, automatically scoring the responses, and immediately integrating results with ECG data to confirm or rule out stroke. This eliminates manual administration time and enables rapid processing, maintaining diagnostic accuracy while minimizing intervention delay.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The questionnaire is prepared and delivered in advance as part of the detection protocol, with response options pre-configured based on common stroke symptoms. This preliminary preparation allows for immediate assessment upon symptom presentation, reducing the time required for comprehensive evaluation while maintaining diagnostic rigor.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If ECG signal monitoring is continuously performed, then detection reliability is improved, but energy consumption increases

Engineering Contradiction:
Improvedetection reliabilityVSAvoidenergy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system employs periodic ECG monitoring with variable sampling rates rather than continuous high-resolution recording. The implantable device performs rhythm analysis at lower power consumption modes, escalating to more intensive monitoring only when arrhythmias or stroke-risk patterns are detected, thereby maintaining detection reliability while significantly reducing overall energy consumption.

Inventive Principle:
Principle #19Periodic action

Data Source

PatentUS8241221B2Systems and methods for use with an implantable medical device for detecting stroke based on electrocardiac signals
Publication Date: 2012.08.14 PACESETTER INC
  • US8241221B2 patent drawing
  • US8241221B2 patent drawing
  • US8241221B2 patent drawing

AI summary

Techniques are provided for detecting stroke within a patient using an implantable medical device in conjunction with an external confirmation system. In one example, a preliminary detection of stroke is performed by a subcutaneous monitor based on an analysis of features of an electrocardiogram (ECG) sensed within the patient. Exemplary ECG features indicative of possible stroke include the onset of prominent U-waves, the onset of notched T-waves, and changes in ST segment duration or QT duration or dynamic trends in these parameters. The monitor transmits a signal indicative of possible stroke to a bedside monitor or other external system, which generates a stroke questionnaire for use in confirming the stroke. Family members or other caregivers input answers to the questionnaire into the external system, which confirms or disconfirms the stroke. Emergency personnel can be automatically notified. Implantable systems that detect stroke based on intracardiac electrogram (IEGM) signals are also described herein.