Optical Shape Sensing for Stent Graft Navigation
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Solution Overview
Problem
Endovascular aneurysm repair (EVAR) procedures face challenges such as endoleaks, misplacement of stent grafts, high contrast and radiation doses due to inadequate imaging and navigation in complex anatomy, and complications like ischemia of aortic side branches, primarily due to the limitations of two-dimensional imaging guidance.
Innovation Solution
The integration of optical shape sensing (OSS) systems with medical devices and deployment instruments to measure and register shape, position, and orientation, enabling three-dimensional visualization and navigation during stent graft deployment, reducing reliance on x-ray guidance and improving positioning accuracy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If x-ray fluoroscopy guidance is used for stent graft deployment, then positioning can be visualized, but radiation dose and contrast dose increase significantly
Solution Approach 1:
The patent replaces x-ray fluoroscopy (electromagnetic radiation-based imaging) with optical shape sensing technology that uses light transmission through optical fibers to measure device shape and position. This substitution eliminates the need for continuous x-ray exposure while providing real-time feedback on stent graft deployment, thereby reducing radiation dose to acceptable levels while maintaining positioning accuracy.
Solution Approach 2:
The patent introduces optical fibers as intermediary sensors embedded within the stent graft structure. These fibers act as mediators that transmit shape and position information from the implantable device to external monitoring systems, enabling visualization of device placement without requiring ionizing radiation or contrast dyes.
2Measurement precision
If x-ray fluoroscopy guidance is used for stent graft deployment, then positioning can be visualized, but contrast dose increases leading to nephropathy
Solution Approach 1:
The patent replaces contrast-enhanced x-ray imaging with optical shape sensing that uses light transmission through optical fibers. This substitution eliminates the need for iodine-based contrast dyes entirely, preventing contrast-induced nephropathy while providing continuous real-time feedback on device position and shape during deployment.
Solution Approach 2:
The patent uses optical fibers as intermediary sensing elements that are integrated into the stent graft structure. These fibers transmit shape information through light modulation without requiring external contrast agents, thereby eliminating the harmful effects of contrast dye accumulation in renal tissue.
3Measurement precision
If two-dimensional x-ray imaging is used for navigation, then device placement can be monitored, but navigation in three-dimensional complex anatomy becomes challenging
Solution Approach 1:
The patent transitions from two-dimensional x-ray fluoroscopy to three-dimensional shape sensing by embedding multiple optical fibers throughout the stent graft structure. This enables measurement of the device's spatial configuration in all three dimensions, providing comprehensive real-time feedback on device position, orientation, and deformation within complex vascular anatomy, thereby greatly improving navigation capability.
Solution Approach 2:
The patent implements real-time feedback by continuously monitoring the shape and position of the stent graft during deployment using optical shape sensing. This feedback is transmitted to external systems that can guide operators through the complex three-dimensional vasculature, enabling precise navigation and placement without relying on limited two-dimensional fluoroscopic images.
4Measurement precision
If optical shape sensing is integrated with medical devices, then three-dimensional visualization and positioning accuracy improve, but device complexity increases
Solution Approach 1:
The patent integrates multiple functions into the stent graft structure by embedding optical fibers that simultaneously serve as structural reinforcement elements and shape sensing sensors. This multi-functionality approach allows the same structural components to provide both mechanical support and measurement capabilities, thereby minimizing the increase in device complexity while achieving three-dimensional visualization and high positioning accuracy.
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 radiation and contrast doses, enhances intuitive navigation within three-dimensional vasculature, decreases procedure times, and improves outcomes by providing precise positioning and alignment of stent grafts, thereby minimizing complications like endoleaks and ischemia.
Implementation Method 1
One principle involved makes use of distributed strain measurement in the optical fiber using characteristic Rayleigh backscatter or controlled grating patterns
Implementation Method 2
Optical shape sensing (OSS) uses light along a multicore optical fiber for device localization and navigation during surgical intervention
Data Source
AI summary
A system for medical device deployment includes an optical shape sensing (OSS) system (104) associated with a deployable medical device (102) or a deployment instrument (107). The OSS system is configured to measure shape, position or orientation of the deployable medical device and/or deployment instrument. A registration module (128) is configured to register OSS data with imaging data to permit placement of the deployable medical device. An image processing module (142) is configured to create a visual representation (102′) of the deployable medical device and to jointly display the deployable medical device with the imaging data.