Fiber-Optic Shape Sensing for Catheter Malposition Detection
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Solution Overview
Problem
Existing intravascular guidance methods for medical devices, such as guidewires and catheters, face issues with radiation exposure from fluoroscopic methods and interference in electromagnetic tracking systems, which are prone to signal dropouts and limited depth range.
Innovation Solution
A fiber optic shape sensing system using a multi-core optical fiber with distributed sensors to determine the trajectory and shape of medical instruments within the vasculature, combined with ECG monitoring, impedance/conductance sensing, and blood flow detection to detect malpositioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic methods are used for tracking medical device tips, then position detection capability is improved, but radiation exposure and contrast media exposure increase
Solution Approach 1:
The patent replaces electromagnetic tracking systems with an optical fiber-based shape sensing system. The optical fiber contains multiple core fibers that sense the catheter's shape through light propagation and analysis, eliminating the need for electromagnetic fields and associated interference issues while providing continuous shape and position information without radiation exposure.
Solution Approach 2:
The patent introduces optical fiber as an intermediary element embedded within the catheter structure. This optical fiber acts as a mediator that directly senses the catheter's physical shape and transmits this information to the control system, providing accurate position detection without requiring external electromagnetic fields or exposing the patient to radiation.
2Object-affected harmful factors
If electromagnetic tracking systems are used for tracking medical devices, then radiation exposure is eliminated, but electromagnetic interference and signal dropout occur
Solution Approach 1:
The patent substitutes electromagnetic tracking with an optical sensing system. The optical fiber-based shape sensor uses light propagation through multiple core fibers to detect catheter shape and position, eliminating susceptibility to electromagnetic interference from consumer electronics while maintaining continuous, reliable tracking without signal dropout.
Solution Approach 2:
The optical fiber serves as an embedded intermediary that directly measures the catheter's physical configuration. This internal optical sensing mechanism provides reliable shape information independent of external electromagnetic fields, ensuring stable tracking signals throughout the procedure without interference from external electronic devices.
3Ease of operation
If electromagnetic tracking systems are used, then line-of-sight reliance is avoided, but depth range and signal stability are limited
Solution Approach 1:
The patent embeds multiple core fibers within the catheter's structural wall, creating a nested configuration where the optical sensing elements are integrated into the catheter itself. This nested arrangement allows the optical fibers to follow the catheter's entire length and shape, providing accurate position and orientation data at all depths without line-of-sight requirements or signal degradation.
Solution Approach 2:
The embedded optical fiber acts as an internal intermediary that directly measures the catheter's shape at every point along its length. This internal sensing mechanism provides continuous, accurate position information throughout the entire depth range of the catheter, eliminating the depth limitations and signal instability associated with external electromagnetic tracking systems.
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
Provides accurate, radiation-free tracking of medical devices, reducing interference and signal dropouts, and ensuring precise placement within vessels by analyzing reflected light signals for strain and shape changes.
Implementation Method 1
each sensor positioned along the same core fiber is configured to reflect light of a different, specific spectral width
Implementation Method 2
The multi-core optical fiber is configured to receive broadband light from a console during advancement through the vasculature of a patient
Implementation Method 3
the broadband light propagates along at least a partial distance of the multi-core optical fiber toward the distal end
Implementation Method 4
These distributed measurements may include wavelength shifts having a correlation with strain experienced by the sensor
Data Source
AI summary
A system, apparatus and method directed to detecting malposition of a medical device within a vessel of a patient, such as an Azygos vein. The medical device can include a multi-core optical fiber including a plurality of core fibers, where each of the plurality of core fibers includes a plurality of sensors is configured to reflect a light signal based on received incident light, and change a characteristic of the reflected light signal for use in determining a physical state of the multi-core optical fiber. The system can include a console having non-transitory computer-readable medium storing logic that, when executed, causes operations of providing a broadband incident light signal to the multi-core optical fiber, receiving reflected light signals, processing the reflected light signals, and determining whether the medical device has entered the Azygos vein of the patient based on the reflected light signals.