Cardiac Signal Episode Display with Undersensing Correction
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Solution Overview
Problem
Implantable medical devices often experience undersensing or oversensing of cardiac signals, leading to inaccurate event detection and patterns, which complicates the identification of heart rhythms and treatment options for patients.
Innovation Solution
The system includes an implantable medical device with a sensing module, processor, and event identification encoder that detects and corrects for undersensing and oversensing by generating adjusted event identification markers and interval measurements, allowing for a more accurate display of cardiac events through a Marker Channel.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If the IMD displays all sensed events as interpreted by the device, then the display shows complete event data, but the accuracy of event identification deteriorates due to undersensing and oversensing errors
Solution Approach 1:
The system introduces an intermediary processing layer between the raw sensed events and the displayed information. The programmer device acts as a mediator that receives event data from the IMD, analyzes the EGM signals to detect undersensing and oversensing errors, corrects the event identification, and then presents the corrected information to the clinician. This intermediary layer preserves complete event data while eliminating identification errors.
Solution Approach 2:
The system creates a corrected copy of the event data by generating alternative interpretations of the EGM signals. When undersensing or oversensing is detected, the system generates corrected event markers that replace the erroneous original markers. This copying approach allows the display to show accurate event information while maintaining the original complete dataset for reference.
2Measurement precision
If the clinician manually analyzes the EGM signal to identify accurate event patterns, then the accuracy of rhythm identification improves, but the efficiency and time required for review deteriorates
Solution Approach 1:
The system performs preliminary analysis of the EGM signals to detect and correct undersensing and oversensing errors before the clinician reviews the data. The automated detection and correction processes run in advance, preparing accurate event identification markers and annotations that the clinician can directly use without manual signal analysis. This preliminary action preserves accuracy while dramatically improving efficiency.
Solution Approach 2:
The system provides self-service by automatically detecting sensing errors and correcting event identification without requiring clinician intervention. The programmed algorithms autonomously analyze the EGM signals, identify undersensing and oversensing patterns, and generate corrected event markers. This self-service capability eliminates the need for manual review while maintaining high accuracy.
3Device complexity
If the IMD uses simple event detection algorithms, then the device complexity is reduced, but the ability to detect and correct sensing errors deteriorates
Solution Approach 1:
The system segments the sensing error detection and correction functionality into separate components: the IMD performs basic event detection with simple algorithms, while the programmer device performs advanced analysis for detecting undersensing and oversensing errors. This segmentation allows the implantable device to remain simple and reliable, while the external device provides sophisticated error detection capabilities.
Data Source
AI summary
A medical device system senses cardiac signals and generates and stores sensing data including sensed cardiac events. A processor receiving the sensing data is configured to detect undersensed and oversensed events. The processor generates an episode display comprising event identifying codes in response to the received sensing data and produces an adjusted episode display in response to an event being identified as an undersensed event or an oversensed event.