Expandable Catheter with Sensor Array for Real-Time Cardiac EP Mapping
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Solution Overview
Problem
Current cardiac electrophysiology mapping systems are cumbersome, time-consuming, and lack precision due to cardiac motion and poor physiological/functional resolution, especially when attempting to create three-dimensional maps of cardiac electrical activity.
Innovation Solution
The system employs a flexible elongated instrument with an expandable portion and an array of sensors and electrodes for real-time ultrasound imaging and electrical characteristic measurement, allowing for precise registration and generation of electro-physiology maps that integrate anatomical and electrical data in real-time, using technologies like inSitu™ for tracking and Fiber-Optical RealShape™ for shape sensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If point-by-point mapping systems are used, then the system can map electrical activity at a single point, but the procedure becomes cumbersome and time-consuming (20-60 minutes)
Solution Approach 1:
The mapping system divides the heart chamber into multiple discrete points or regions, with electrodes distributed across the chamber to simultaneously capture electrical activity at multiple locations. This segmentation approach allows parallel data collection from numerous heart regions, transforming a sequential point-by-point process into a concurrent multi-point mapping system that reduces procedure time while maintaining measurement precision.
Solution Approach 2:
The system transitions from one-dimensional point-by-point mapping to three-dimensional spatial mapping by deploying electrodes in a distributed array throughout the heart chamber. This dimensional expansion enables simultaneous capture of electrical activity across multiple spatial coordinates, creating a comprehensive 3D electro-anatomical map that dramatically reduces mapping time while preserving detailed electrical activity information.
2Measurement precision
If point-by-point mapping systems are used, then the system can map electrical activity, but it suffers from cardiac motion and has poor physiological/functional resolution
Solution Approach 1:
The system performs preliminary registration of electrode positions with the three-dimensional anatomical map before electrical activity acquisition. By pre-establishing the spatial relationship between electrodes and heart structures, the system creates a reference framework that remains valid despite cardiac motion during data collection, thereby maintaining mapping accuracy and reliability throughout the procedure.
Solution Approach 2:
The system continuously tracks electrode positions and updates the mapping in real-time based on detected cardiac motion. This feedback mechanism allows the system to compensate for heart movement by dynamically adjusting the spatial coordinates of recorded electrical signals, ensuring that the final electro-anatomical map accurately reflects the true anatomical positions despite physiological motion during data acquisition.
3Productivity
If multi-electrode non-contact mapping systems are used, then more points can be mapped simultaneously, but they lack three-dimensional constraints
Solution Approach 1:
The system introduces a three-dimensional electro-anatomical map as an intermediary structure that provides spatial constraints for non-contact electrode positioning. This virtual anatomical framework serves as a reference system, allowing the non-contact electrodes to be accurately localized in 3D space by referencing their positions relative to the pre-established anatomical map, thereby gaining spatial precision without sacrificing mapping speed.
Solution Approach 2:
The system creates a three-dimensional digital copy or replica of the heart chamber anatomy through imaging modalities. This virtual anatomical model serves as a precise spatial template that guides and constrains the positioning of non-contact electrodes, enabling accurate 3D localization of electrical activity measurements without requiring physical contact with the heart tissue, thus maintaining both productivity and measurement precision.
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
This approach enables fast, accurate, and precise three-dimensional characterization of cardiac electrical and mechanical parameters, improving the efficacy of cardiac procedures by providing detailed, real-time maps during and after interventions.
Implementation Method 1
an array of sensors and electrodes distributed on the expandable portion and is configured to concurrently the instrument to real-time images of an anatomy using the sensors
Implementation Method 2
measure electrical characteristics of the anatomy with the electrodes to generate an electro-physiology (EP) map having the anatomy and intensities of the electrical characteristics mapped together
Data Source
AI summary
An instrument for internal mapping includes a flexible elongated portion (702) and an expandable portion (710) coupled distally to the elongated portion, the expandable portion having one or more expandable loops. An array of sensors (706) and electrodes (708) is distributed on the expandable portion and is configured to concurrently register the instrument to real-time images of an anatomy using the sensors and measure electrical characteristics of the anatomy with the electrodes to generate an electro-physiology (EP) map having the anatomy and intensities of the electrical characteristics mapped together in the real-time images.