Antegrade TAVR Catheter Navigation Through the Mitral Valve
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Solution Overview
Problem
Antegrade transcatheter aortic valve replacement (TAVR) procedures are historically difficult due to challenges such as the need for an atrial septal crossing, potential damage to the mitral valve, and issues with delivering large-profile implantation devices through the left atrium, leading to their largely being supplanted by retrograde approaches despite their associated complications.
Innovation Solution
The use of an outer catheter and interchangeable inner catheters configured for monorail advancement, with steerable and bendable regions, and an expandable deflector to navigate through the mitral valve without engaging chordae tendinae, combined with rapid pacing to ensure safe aortic valve deployment, facilitates antegrade delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If retrograde TAVR approach is used, then catheter delivery pathway is simpler, but major bleeding at arterial access site and stroke from embolic debris occur
Solution Approach 1:
The patent applies the inversion principle by reversing the traditional retrograde approach and using an antegrade TAVR method where the catheter is advanced in the direction of blood flow from the left ventricle through the aortic valve, rather than approaching from the aorta backward through the valve. This fundamental directional reversal eliminates contact with the aortic arch and arterial access sites, thereby preventing embolic debris and major bleeding complications while still achieving valve replacement.
Solution Approach 2:
The patent uses the left ventricle and mitral valve as intermediary structures to access the aortic valve. By passing through the mitral valve into the left ventricle and then advancing through the aortic valve, the system creates a safe intermediary pathway that avoids direct interaction with the problematic aortic arch and arterial access sites, thereby eliminating the harmful effects of embolic debris and bleeding.
2Object-affected harmful factors
If antegrade TAVR procedure is used, then bleeding and stroke are reduced, but procedure difficulty increases due to atrial septal crossing and mitral valve navigation
Solution Approach 1:
The patent applies preliminary action by performing transseptal puncture and mitral valve crossing before deploying the aortic valve replacement device. The system first establishes access through the atrial septum into the left atrium, then navigates through the mitral valve into the left ventricle, and finally positions the aortic valve prosthesis. This sequential preliminary preparation simplifies the overall procedure by breaking down the complex antegrade approach into manageable steps that can be performed in a logical order.
Solution Approach 2:
The patent segments the complex antegrade TAVR procedure into distinct phases: (1) transseptal puncture and atrial access, (2) mitral valve crossing and left ventricular entry, (3) aortic valve positioning and deployment. By dividing the procedure into these separate segments, each with its own specialized catheters and techniques, the overall complexity is reduced and the procedure becomes more manageable and reproducible.
3Reliability
If large-profile implantation device is delivered through left atrium, then aortic valve replacement is achieved, but damage to mitral valve and delivery difficulties occur
Solution Approach 1:
The patent applies dynamics by using a collapsible and expandable aortic valve prosthesis that can be compressed to a small profile for delivery through the mitral valve and left atrium, then expanded to its functional size after positioning in the aortic valve. This dynamic size transformation allows the large-profile implantation device to pass through narrow passages without causing damage to the mitral valve or creating delivery difficulties, while still achieving reliable aortic valve replacement.
Solution Approach 2:
The patent uses the nested doll principle by placing the aortic valve prosthesis within a delivery catheter system that provides protection and guidance during transit through the left atrium and mitral valve. The collapsible prosthesis is nested within the catheter lumen in a compressed state, allowing it to pass through narrow anatomical structures without damaging the mitral valve, then deployed in its expanded functional configuration once positioned in the aortic valve.
Data Source
AI summary
Methods, apparatuses, and systems for performing a valve replacement or repair. Apparatuses may include systems and may include an outer catheter, one or more interchangeable inner catheters, a guidewire and an expandable chordae tendinae deflector. Also described herein are rapid pacing sheaths that may be used with any of these apparatuses and methods.