EP Mapping Visualization for Cardiac Lead Placement
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Solution Overview
Problem
Current methods for placing cardiac leads, such as pacemakers and implantable cardiac defibrillators, rely heavily on fluoroscopy, which exposes patients, operators, and staff to significant radiation, increasing the risk of health issues like malignancy, and lacks precise imaging guidance during procedures.
Innovation Solution
Integration of magnetic field sensors and electrodes with cardiac electrophysiology mapping systems allows for real-time visualization of interventional devices, like pericardiocentesis needles and sheaths, within the heart, reducing radiation exposure by using non-fluoroscopic navigation and combining imaging modalities like CT and echocardiography.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used for lead placement visualization, then real-time imaging guidance is provided, but radiation exposure to patient, operator, and staff increases significantly
Solution Approach 1:
The patent replaces the fluoroscopy-based mechanical imaging system with an electrophysiology mapping system that uses electrical field sensing and signal processing to visualize cardiac structures and lead positions, thereby eliminating radiation exposure while maintaining imaging guidance capability
Solution Approach 2:
The patent introduces electrophysiology catheters with electrodes as intermediaries that sense electrical signals from the heart, allowing indirect visualization of cardiac anatomy and lead placement through electrical field mapping rather than direct radiation-based imaging
2Object-affected harmful factors
If electrophysiology mapping system is used for lead placement visualization, then radiation exposure is minimized, but system complexity and setup requirements increase
Solution Approach 1:
The patent leverages the existing electrophysiology mapping system's multi-functionality by using its electrodes and signal processing capabilities for both traditional electrophysiology studies and structural visualization during lead placement, reducing the need for separate dedicated systems
Solution Approach 2:
The patent utilizes the electrophysiology mapping system's inherent electrical field sensing capabilities and existing software infrastructure to provide structural visualization, allowing the system to serve multiple purposes without requiring entirely new technology or complex additional components
3Manufacturing precision
If EP mapping system visualizes interventional devices, then lead placement precision is improved, but additional sensors and integration requirements increase device complexity
Solution Approach 1:
The patent combines the interventional lead/device with the electrophysiology mapping system's existing electrode array and signal processing infrastructure, merging their functions to achieve precise visualization without requiring completely separate sensing systems
Solution Approach 2:
The patent uses disposable electrophysiology catheters with integrated electrodes that are single-use items, eliminating the need for permanent implanted sensors while providing sufficient precision for the procedure, then discarded after use
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 enhances the precision and safety of lead placement procedures by minimizing radiation exposure, improving operator and patient safety, and providing detailed, accurate imaging without the need for fluoroscopy, thus reducing the risk of radiation-related health issues.
Implementation Method 1
The Biosense Webster Carto 3, provided by Biosense Webster, Inc. of Diamond Bar, Calif., uses magnetic sensors within a magnetic field for positional information of catheters within the heart
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
Implementation Method 3
This system also uses a background electric field utilizing current to localize electrodes on non-magnetic sensor EP catheters
Data Source
AI summary
Cardiac interventional devices are fitted with sensors coupled to an electrophysiology (EP) mapping system. The sensors can be in the form of electrodes and/or magnetic field sensors which are placed strategically upon the interventional devices. The interventional devices can thus be visualized on the EP mapping display when the interventional devices are being routed through various pathways adjacent to the heart of a patient. The interventional devices can include sheaths, and especially two part sheaths with a base separate from a tube, which base can be separated from the tube at an interface. Other interventional devices include an exoskeleton attachable to a lead, needles, guide wires, dilators, J wires and luminal catheters. The sensors are located along the interventional devices, typically including a sensor at a distal tip, as well as along a length of the interventional device, proximal of the distal tip, and with known spacing to further allow the interventional device to be fully and accurately caused to appear on the EP mapping display.