Self-Expanding Emboli-Capturing Centering Device
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Solution Overview
Problem
Current methods for accessing the left ventricle through a severely stenotic aortic valve during procedures like TAVR are challenging due to the risk of dislodging calcified debris, leading to emboli and increased stroke risk, especially when trying to align a guidewire against the blood flow.
Innovation Solution
A self-expanding emboli-capturing centering device with a flared shape and filter material is used to align the guide catheter with blood flow, capturing emboli and facilitating the advancement of a guidewire through the valve while reducing the risk of embolization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If repeated probing of the stenotic valve with a guidewire is performed to penetrate the orifice, then the guidewire can eventually cross the valve, but the risk of dislodging calcified debris and generating emboli increases
Solution Approach 1:
The centering device is deployed before guidewire crossing attempts to establish proper alignment and protect the valve orifice. By pre-positioning the device with its flared shape and filter material, the system prepares the pathway in advance, reducing the need for repeated probing and minimizing embolization risk during subsequent guidewire advancement.
Solution Approach 2:
The centering device acts as an intermediary structure between the catheter and the stenotic valve. Its flared shape provides mechanical centering while the filter material serves as a protective intermediary that captures dislodged debris, allowing guidewire crossing attempts without direct exposure of the valve to embolic risk.
2Reliability
If the guide catheter is repeatedly repositioned to align with the valve orifice, then successful crossing may be achieved, but procedural time and radiation exposure increase
Solution Approach 1:
The centering device performs self-alignment through its flared shape that naturally centers itself within the catheter lumen and aligns with the valve orifice using blood flow forces. This self-centering mechanism eliminates the need for repeated manual repositioning by the operator, reducing procedural time while maintaining reliable alignment for successful crossing.
Solution Approach 2:
The device provides visual feedback through radiopaque markers that indicate proper positioning and alignment with the valve orifice. This feedback mechanism allows the operator to confirm correct placement without repeated trial-and-error positioning, reducing radiation exposure and procedural time while ensuring reliable alignment.
3Reliability
If the guide catheter is repeatedly repositioned to align with the valve orifice, then successful crossing may be achieved, but radiation exposure for patients and physicians increases
Solution Approach 1:
The centering device incorporates radiopaque markers that provide clear visual feedback during fluoroscopy, allowing the operator to confirm proper alignment and positioning in a single view. This reduces the need for repeated imaging and repositioning attempts, thereby minimizing radiation exposure to both patients and physicians while maintaining high crossing success rates.
4Object-affected harmful factors
If a filter material is added to capture emboli, then stroke risk is reduced, but device complexity increases
Solution Approach 1:
The filter material is integrated into the wall structure of the centering device itself, combining the embolic protection function with the existing centering mechanism. This merging of functions avoids adding separate components and keeps the overall device structure relatively simple while providing effective emboli capture to reduce stroke risk.
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 solution reduces the risk of thromboembolic strokes, decreases procedural costs and radiation exposure, and improves the success rate of crossing the aortic valve by aligning the guide catheter with the blood flow and filtering out emboli during cardiac catheterization procedures.
Implementation Method 1
The centering member is self-expanding and has a flared shape when deployed
Implementation Method 2
filter material configured to filter the fluid received by the open distal end of the centering member
Data Source
AI summary
In some aspects, the present disclosure pertains to self-expanding emboli-capturing centering devices for centering a medical instrument in a conduit within a patient. The centering devices comprise (a) an elongate shaft, (b) a self-expanding centering member having an open distal end and an inner surface forming a central lumen with a flared distal portion, the centering member being configured such that a fluid flowing in a distal-to-proximal direction that is received by the open distal end flows proximally along the flared distal portion of the central lumen before exiting the central lumen through one or more openings in a proximal portion of the centering member, and (c) a filter material configured to filter the fluid received by the open distal end of the centering member. Other aspects of the present disclosure pertain to systems and methods employing such centering devices.