Position Sensing Unit for Cardiac Lead Navigation
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Solution Overview
Problem
The use of imaging devices like fluoroscopes for implanting implantable medical devices (IMDs) requires costly equipment, extensive training, and exposes personnel to ionizing radiation, limiting the number of facilities capable of performing certain procedures.
Innovation Solution
A position sensing unit (PSU) system that maps and illustrates electrode positions within the body, eliminating the need for external imaging devices by generating a voltage and calculating impedance to determine electrode location, thereby guiding lead placement without external imaging.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopes are used for implanting IMDs, then imaging guidance is achieved, but ionizing radiation exposure and equipment cost increase
Solution Approach 1:
The patent replaces the mechanical/optical imaging system (fluoroscope) with an electrical field-based sensing system. The PSU generates electrical signals and measures impedance to determine lead position, substituting ionizing radiation-based imaging with non-ionizing electrical measurements that provide equivalent spatial information without harmful radiation exposure.
Solution Approach 2:
The patent introduces electrical impedance as an intermediary parameter to infer lead position. Instead of directly visualizing the lead with imaging devices, the system measures electrical impedance between the lead electrode and body surface electrodes, using this intermediate electrical measurement to calculate and display lead position on an anatomical map.
2Measurement precision
If fluoroscopes are used for implanting IMDs, then imaging guidance is achieved, but equipment cost and training requirements increase
Solution Approach 1:
The patent employs relatively simple, inexpensive electrical sensing components (electrodes and impedance measurement circuitry) instead of expensive fluoroscopic equipment. The system uses basic electrical measurement principles that require minimal specialized training compared to operating complex imaging devices, making the technology accessible to more facilities.
Solution Approach 2:
The patent replaces complex mechanical/optical imaging equipment with simpler electrical measurement systems. The PSU and associated electronics provide imaging-guidance functionality through electrical impedance measurements, eliminating the need for expensive fluoroscopes and reducing training requirements to operate the equipment.
3Loss of information
If external imaging devices are used, then lead position is visualized, but procedural time and facility requirements increase
Solution Approach 1:
The patent enables continuous real-time measurement of lead position through continuous electrical impedance monitoring. As the lead is moved or positioned, the PSU continuously measures impedance and updates the anatomical map display, providing uninterrupted positional information without the intermittent image acquisition cycles required by fluoroscopy, thereby reducing procedural time.
Solution Approach 2:
The patent replaces time-consuming mechanical imaging procedures with rapid electrical measurements. Electrical impedance can be measured instantaneously and updated in real-time, providing lead position information faster than fluoroscopic image acquisition and interpretation, thus reducing overall procedural time.
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 solution reduces costs, eliminates the need for protective clothing and radiation exposure, and allows more facilities to perform procedures by navigating leads to selected locations within the anatomy without external imaging devices.
Implementation Method 1
The system can determine the location of an electrode by generating a voltage in a patient and calculating an impedance at the electrode. The calculated impedance is used to determine the position of the electrode as in a patient or other appropriate conducting medium.
Data Source
AI summary
An area of a patient can be mapped with a system operable to identify a plurality of locations and save a plurality of locations of a mapping instrument. The mapping instrument can include one or more electrodes that can sense a voltage that can be correlated to a three dimensional location of the electrode at the time of the sensing or measurement. Therefore, a map of an area or volume can be determined based upon the sensing of the plurality of points without the use of an imaging device. An implantable medical device can then be navigated relative to the mapping data.