Expandable Steering Device for Catheter Navigation in Cardiac Vessels
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Solution Overview
Problem
Conventional guidewires and catheters face limitations in navigation and control due to their flexibility, remote manipulation, and limited visualization, leading to challenges in accurately positioning and steering these devices during cardiovascular procedures.
Innovation Solution
The proposed system incorporates an electromechanical steering device with expandable structures and strings, allowing for precise control and positioning of the catheter tip within a vessel lumen or cardiac chamber. This system includes position sensors and a user interface for real-time tracking and visualization of the device's position relative to anatomical structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional guidewires are made extremely flexible to navigate vessel geometry, then the device can adapt to anatomical structures, but the ability to steer and control the tip position is severely limited
Solution Approach 1:
The guidewire is divided into multiple segments or sections along its length, with each section having different flexibility characteristics. The distal tip section is more flexible to navigate vessel geometry, while proximal sections maintain higher stiffness for controllability. This segmentation allows the wire to be both adaptable to anatomy and steerable by the operator.
Solution Approach 2:
Different portions of the guidewire have locally optimized properties: the distal tip is made extremely flexible with lower stiffness to conform to vessel geometry, while the shaft maintains higher stiffness for mechanical control. This local differentiation of mechanical properties resolves the contradiction between adaptability and steerability.
2Device complexity
If guidewires are manipulated remotely from outside the patient body with only two DOF, then the device structure remains simple, but navigation to target locations becomes time-consuming and difficult
Solution Approach 1:
The guidewire incorporates dynamic shape memory materials or active control mechanisms that allow the wire to change its shape and stiffness characteristics in response to electrical signals or thermal stimuli. This enables the wire to navigate complex anatomy more quickly by actively conforming to vessel paths rather than relying solely on passive manipulation.
Solution Approach 2:
The patent replaces purely mechanical manipulation with a hybrid system incorporating electromagnetic or acoustic fields to actuate the guidewire. This substitution of mechanical control with field-based actuation enables more precise and faster navigation while maintaining relatively simple device structure.
3Device complexity
If x-ray fluoroscopic imaging is used to guide the procedure, then the imaging system is widely available and relatively simple, but visual feedback is limited with only 2D projection images
Solution Approach 1:
The patent combines multiple imaging modalities including x-ray fluoroscopy with advanced 3D imaging techniques such as cone-beam CT or ultrasound. This merging of imaging systems provides both the availability of x-ray and the enhanced 3D visualization needed for precise position feedback, resolving the contradiction between system simplicity and measurement precision.
Solution Approach 2:
The imaging system transitions from 2D fluoroscopic projection to 3D volumetric imaging, adding a spatial dimension to the visual feedback. This dimensional enhancement provides comprehensive position information while maintaining integration with the existing x-ray infrastructure.
4Object-affected harmful factors
If the guidewire tip is made highly flexible to follow vessel shape, then the device can navigate anatomical structures safely, but the force control and position estimation at the tip become difficult
Solution Approach 1:
The guidewire incorporates sensors at the tip that provide real-time feedback on position, orientation, and contact forces. This feedback is transmitted to the operator or control system, enabling precise estimation and control of tip conditions even in highly flexible sections. The feedback loop resolves the contradiction by providing measurement data that would otherwise be unavailable in flexible regions.
Solution Approach 2:
The patent introduces intermediary measurement devices such as electromagnetic trackers or optical markers attached to the guidewire that serve as mediators between the flexible wire and the imaging/measurement system. These intermediaries enable accurate position and force estimation without requiring direct measurement of the flexible wire itself.
Data Source
AI summary
A steering device and navigation system for interventional procedures. Included are devices, systems, and methods that incorporate a steering device which consists of an expandable structure that can be controlled to spread out within the vessel lumen, or cardiac chamber, and may apply circumferential force to the tissue. This structure, once spread out, can anchor relative to the anatomy and provides support for an internal catheter through a set of strings connected to the internal catheter. The internal catheter is configured to allow an interventional device, such as a guidewire or catheter, to pass through it. Using the strings that are connected to actuation mechanisms within the device's handle, the internal catheter can be manipulated to allow 10 controlling the position of a device that runs within it or is connected to it and can be used for the purpose of navigation of devices and obtaining measurements from known positions.