Fiber Optic Tip Placement Detection for Vascular Malposition
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Solution Overview
Problem
Existing electromagnetic tracking systems for medical devices are prone to interference from consumer electronics, suffer from signal dropouts, and have limited depth range, exposing patients to radiation and harmful contrast media.
Innovation Solution
A fiber optic shape sensing system using a multi-core optical fiber with spatially distributed sensors to determine the trajectory and shape of medical instruments, combined with ECG monitoring, impedance/conductance sensing, and blood flow detection to detect malposition within a patient's vasculature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic methods are used for tracking medical devices, then tip placement can be determined, but patients and clinicians are exposed to harmful X-ray radiation and potentially harmful contrast media
Solution Approach 1:
The patent replaces electromagnetic tracking systems with an optical tracking system using a distal tip indicator that reflects or emits light. This substitution eliminates the need for electromagnetic fields, avoiding interference from consumer electronics while providing continuous, reliable tracking of the medical device tip without radiation exposure to patients and clinicians.
Solution Approach 2:
The patent introduces a distal tip indicator as an intermediary element attached to the medical device tip. This indicator reflects or emits light to enable optical tracking, serving as a mediator between the medical device and the tracking system. This approach allows precise tip placement determination without requiring direct electromagnetic interaction with the device, thereby eliminating radiation exposure.
2Object-affected harmful factors
If electromagnetic tracking systems are used to avoid radiation exposure, then line-of-sight reliance is avoided and radiation exposure is eliminated, but the systems are prone to interference from consumer electronics and signal dropout
Solution Approach 1:
The patent replaces electromagnetic tracking with optical tracking using a distal tip indicator. This substitution eliminates susceptibility to electromagnetic interference from consumer electronics while maintaining continuous, reliable tracking. The optical system uses light reflection or emission from the tip indicator, providing stable tracking signals without the dropout issues inherent in electromagnetic systems.
3Object-affected harmful factors
If electromagnetic tracking systems are used, then radiation exposure is avoided, but the systems are defined to a limited depth range and require external sensors
Solution Approach 1:
The patent makes the medical device self-tracking by attaching a distal tip indicator directly to the device tip. This indicator reflects or emits light, enabling the device to track itself without requiring external sensors or emitters. This self-service approach simplifies the overall system complexity while eliminating the need for separate external tracking components.
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, non-invasive tracking of medical devices, avoiding radiation exposure and interference, with enhanced depth range and precision in detecting deviations from target paths.
Implementation Method 1
The multi-core optical fiber is configured to receive broadband light from a console during advancement through the vasculature of a patient, where the broadband light propagates along at least a partial distance of the multi-core optical fiber toward the distal end
Implementation Method 2
Given that each sensor positioned along the same core fiber is configured to reflect light of a different, specific spectral width, the array of sensors enable distributed measurements throughout the prescribed length of the multi-core optical fiber. These distributed measurements may include wavelength shifts having a correlation with strain experienced by the sensor
Implementation Method 3
the system is a fiber optic shape sensing system and methods thereof, configured to provide confirmation of tip placement or information passed/interpreted as an electrical signal
Data Source
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AI summary
Disclosed herein is 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 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 a 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.