Position Sensing Unit for Medical Device Navigation
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Solution Overview
Problem
Current methods for implanting medical devices, such as pacemakers, require the use of imaging devices like fluoroscopes, which are costly, require extensive training, and expose personnel to ionizing radiation, limiting the number of facilities that can perform procedures due to the need for external imaging.
Innovation Solution
A Position Sensing Unit (PSU) system that maps and illustrates electrode positions within the body without external imaging, using voltage and impedance measurements to determine electrode location, allowing for navigation and placement of medical devices without the need for fluoroscopes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscope imaging devices are used to guide electrode placement, then accurate positioning can be achieved, but the cost increases, radiation exposure occurs, and extensive training is required
Solution Approach 1:
The patent replaces the mechanical/optical imaging system (fluoroscope) with an electrical field-based positioning system. The PSU generates electrical signals and measures impedance to determine electrode positions without requiring ionizing radiation or complex imaging equipment. This substitution eliminates radiation exposure and reduces equipment complexity while maintaining positioning accuracy through electrical property measurements.
Solution Approach 2:
The patent introduces an intermediary electrical field as a mediator between the electrode and the positioning system. Instead of directly imaging the electrode position, the system uses the electrical field and impedance measurements as an intermediary to infer position. This intermediary approach allows accurate positioning without requiring direct visual imaging, thereby reducing equipment complexity and eliminating radiation.
2Reliability
If fluoroscope devices are used for imaging, then real-time visualization is provided, but heavy protective clothing is required and operational efficiency decreases
Solution Approach 1:
The positioning system is self-sufficient and does not require external imaging equipment or protective clothing infrastructure. The PSU independently provides real-time positioning information through electrical measurements, eliminating the need for heavy protective clothing and associated safety protocols that slow down operations. This self-service capability directly improves operational efficiency while maintaining reliable real-time positioning.
3Loss of information
If imaging devices are acquired to perform procedures, then comprehensive visualization is achieved, but the cost increases and facility availability decreases
Solution Approach 1:
The patent employs a low-cost, portable positioning system that does not require expensive, fixed imaging infrastructure. The PSU is a relatively simple device that can be deployed without major facility investments. This approach makes the technology accessible to facilities that cannot afford comprehensive imaging equipment, thereby increasing facility availability while providing sufficient information for safe electrode placement.
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 reduces the need for costly imaging equipment, minimizes radiation exposure, and allows more facilities to perform procedures by enabling accurate electrode placement using internal mapping, thereby improving operational efficiency and safety.
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
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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.