Stylet Shape Sensing with Patient-Based Reference Framing
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Solution Overview
Problem
Current intravascular medical device guidance methods using fluoroscopy expose patients and clinicians to harmful radiation and contrast media, and optical systems without a patient-based reference frame can suffer from orientation-type shape-sensing errors due to torsional strains on optical fibers.
Innovation Solution
A medical-device visualization system utilizing a stylet with an optical fiber and field generator, patient-wearable sensors, and a console for real-time shape sensing, registration, and reference framing, correcting orientation-type errors by triangulating the distal tip with patient-wearable sensors and establishing a patient-based reference frame.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopic methods are used for intravascular guidance, then device placement can be visualized, but patients and clinicians are exposed to harmful radiation and contrast media
Solution Approach 1:
The patent replaces the fluoroscopic imaging system with an optical fiber-based shape sensing system. The optical fiber detects mechanical deformations and torsional strains along its length, converting mechanical information into optical signals that can be visualized without radiation. This substitution eliminates harmful radiation and contrast media exposure while maintaining the ability to visualize device placement and orientation within the vasculature.
2Object-affected harmful factors
If optical fiber shape sensing is used without a patient-based reference frame, then radiation exposure is avoided, but orientation-type shape-sensing errors occur due to torsional strains
Solution Approach 1:
The patent introduces a patient-based reference frame as an intermediary that links the optical fiber measurements to the patient's anatomical coordinate system. This reference frame is established using surface landmarks and imaging data, serving as a mediator that transforms the raw optical fiber measurements (which are affected by torsional strains) into accurate spatial orientation information relative to the patient's anatomy. This resolves the measurement errors while maintaining the radiation-free advantage.
Solution Approach 2:
The system incorporates feedback mechanisms where the optical fiber measurements are continuously compared with the patient-based reference frame and visualized in real-time. This feedback loop allows the system to detect and correct orientation errors caused by torsional strains by referencing the known anatomical landmarks and adjusting the shape sensing data accordingly, ensuring accurate orientation information is provided throughout the procedure.
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
Enables accurate, radiation-free visualization of intravascular devices by correcting shape-sensing errors and providing real-time feedback on device placement within the patient's vasculature.
Implementation Method 1
determining a shape of the stylet in real-time from reflected optical signals reflected by the optical sensors
Implementation Method 2
Each sensor of the patient-wearable sensors is configured to sense a field generated by the field generator
Data Source
AI summary
A medical device visualization system includes a stylet, a plurality of patient-wearable sensors, and a console. The stylet includes an optical fiber with a plurality of sensors distributed along a length thereof, and a field generator in a distal tip. The plurality of patient-wearable sensors are configured to sense a field generated by the field generator. The console is configured for visualizing the stylet as it is advanced in a patient. A visualization process can include a shape-sensing process, a registration process, and a reference-framing process. The shape-sensing process can utilize shape-sensing logic for determining a shape of the stylet in real-time from reflected optical signals reflected by the plurality of sensors. The registration process can utilize registration logic for registering the distal tip of the stylet. The reference-framing process can utilize reference-framing logic for placing the stylet in a reference frame.