Electrophysiology Mapping System Using Magnetic Sensors for Lead Placement
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Solution Overview
Problem
Current methods for visualizing the placement of pacemakers and implantable cardiac defibrillators expose patients, operators, and staff to significant radiation, increasing the risk of health issues such as malignancy, and lack precision in lead placement procedures.
Innovation Solution
Integration of magnetic sensors or electrodes with cardiac electrophysiology mapping systems to allow for real-time visualization of subcutaneous interventional equipment, such as pericardiocentesis needles, sheaths, and guide wires, reducing the need for fluoroscopy and enhancing precision in placement without radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used for visualization of lead placement, then real-time imaging guidance is achieved, but radiation exposure to patient, operator and staff increases significantly
Solution Approach 1:
The patent introduces an intermediary imaging system (electromagnetic field-based tracking system) that mediates between the need for real-time visualization and the harmful radiation from fluoroscopy. This intermediary system uses electromagnetic fields and sensors to track catheter and lead positions without ionizing radiation, thus resolving the contradiction by providing an alternative visualization method that maintains imaging accuracy while eliminating radiation exposure.
Solution Approach 2:
The patent replaces the mechanical/optical system of fluoroscopy (X-ray based imaging) with an electromagnetic field-based tracking system. Instead of using ionizing radiation to visualize structures, the system uses electromagnetic sensors and field interactions to detect and track the position of medical devices, substituting a harmful mechanical/radiation-based system with a safer electromagnetic sensing approach.
2Object-affected harmful factors
If traditional lead placement procedures are performed without advanced imaging, then radiation exposure is reduced, but precision in lead placement deteriorates
Solution Approach 1:
The patent implements a feedback mechanism where electromagnetic sensors continuously detect the position of leads and catheters, and this position information is fed back to the operator in real-time through a display system. This feedback loop enables precise lead placement by providing continuous positional information without requiring fluoroscopy, thus achieving high placement precision while maintaining low radiation exposure.
Solution Approach 2:
The patent creates a multi-functional system that combines electromagnetic field generation, sensor detection, real-time position calculation, and visual display into a single integrated platform. This universal system serves multiple functions: it provides real-time imaging guidance, tracks multiple devices simultaneously, and offers precise positioning information, all without using ionizing radiation, thereby resolving the contradiction between reduced radiation and maintained precision.
3Measurement precision
If EP mapping systems are integrated with subcutaneous interventional equipment, then visualization precision improves, but device complexity increases
Solution Approach 1:
The patent merges the EP mapping system with subcutaneous interventional equipment by integrating electromagnetic sensors directly into the interventional devices (needles, sheaths, guide wires). This merging allows the location and orientation of these equipment to be visualized on the EP mapping system display, achieving precise location accuracy while managing system complexity through integrated design rather than separate coupled components.
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 minimizes radiation exposure for patients and medical professionals while improving the precision of lead placement procedures, enabling safer and more accurate interventions within cardiac electrophysiology suites.
Implementation Method 1
Fluoroscopy is traditionally the accepted method of visualization of the leads for placement within the heart. However this exposes the patient, operator and staff members to radiation.
Implementation Method 2
The EN SITE system provided by St. Jude Medical, Atrial Fibrillation Division, Inc. of St. Paul, Minn., uses impedance to localize various catheters relative to a stable catheter located within the heart.
Data Source
AI summary
An electrophysiology mapping system is provided with modules which can be attached thereto, each module including an item of subcutaneous interventional equipment and information about the item of subcutaneous interventional equipment, including shape information and size information. At least one sensor is placed upon the item of subcutaneous interventional equipment at a known location thereon. This sensor allows for position, and also preferably orientation, of the item within an image presented on a display of the electrophysiology mapping system. The at least one sensor can be at least one electrode or two or more electrodes, with different known positions for the electrode, or electrodes. The at least one sensor can be one or more magnetic field sensors interacting with a magnetic field associated with the electrophysiology mapping system. Transthoracic ultrasound fitted with sensors thereon can also be utilized as a further module attachable to the electrophysiology mapping system.