Position Sensing Unit for Lead Navigation Without Imaging
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Solution Overview
Problem
Current medical procedures for implanting devices like pacemakers and defibrillators require expensive imaging devices and extensive training, exposing personnel to ionizing radiation and increasing costs, which limits the number of facilities capable of performing these procedures.
Innovation Solution
A position sensing unit (PSU) system that maps anatomical structures by generating a voltage and calculating impedance to determine the position of electrodes, allowing for navigation and placement of leads without external imaging devices like fluoroscopes, reducing the need for costly equipment and radiation exposure.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy imaging devices are used to guide lead implantation, then real-time visualization of lead position is achieved, but personnel are exposed to ionizing radiation and operational complexity increases
Solution Approach 1:
The patent extracts the imaging function from external fluoroscopy equipment and implements it within the implantable medical device itself through telemetry. The device determines its own position by measuring electrical properties (impedance, voltage, current) of the surrounding tissue and transmitting this data wirelessly to an external programmer, eliminating the need for separate imaging devices and radiation exposure.
Solution Approach 2:
The patent uses electrical measurements (impedance, voltage, current) as intermediaries to indirectly determine lead position. Instead of directly visualizing the lead with fluoroscopy, the system measures electrical properties of the tissue that change with lead position, using these measurements as a mediator to infer location without radiation.
2Measurement precision
If fluoroscopy imaging devices are used to guide lead implantation, then real-time visualization of lead position is achieved, but device complexity and cost increase
Solution Approach 1:
The patent merges the imaging guidance function with the implantable medical device itself. The same device that delivers therapy also determines and communicates its own position through integrated telemetry capabilities, combining multiple functions into a single device and eliminating the need for separate imaging equipment.
Solution Approach 2:
The implantable device performs self-positioning determination by autonomously measuring its own electrical environment and transmitting position data to external systems. The device serves its own guidance needs without requiring external imaging infrastructure, reducing overall system complexity.
3Measurement precision
If impedance measurements are performed using multiple electrodes, then lead position determination accuracy is improved, but the system requires additional electrodes and increased complexity
Solution Approach 1:
The patent makes the electrodes multi-functional: they serve both as therapy delivery electrodes and as position sensing electrodes. The same electrodes used for pacing or defibrillation are also used to measure impedance and determine lead position, eliminating the need for separate sensing electrodes and reducing overall complexity.
Solution Approach 2:
The patent changes the measurement parameter from simple voltage to impedance (resistance), which provides more information about tissue characteristics and lead position. By measuring impedance between different electrode combinations, the system achieves accurate positioning using the existing electrode array without adding more electrodes.
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
The PSU system enables precise navigation and placement of medical devices within anatomical structures without external imaging, reducing costs, minimizing radiation exposure, and expanding the capabilities of medical facilities to perform complex procedures.
Implementation Method 1
The tracking element can be an electrode and a position is determined 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 volume 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 a volume can be determined based upon the sensing of the plurality of points without the use of other imaging devices. An implantable medical device can then be navigated relative to the mapping data.


