Guide Member Docking for Mitral Valve Alignment
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Solution Overview
Problem
Current minimally invasive transcatheter-based systems face challenges in precisely locating and orienting prosthetic heart valves relative to native anatomy, particularly in complex anatomical structures like the mitral valve, due to difficulties in navigating tortuous paths and aligning the valve with the native annulus during delivery.
Innovation Solution
The use of a guide member assembly with a docking structure that interfaces with native anatomy, such as mitral valve leaflets, chordae, or ventricular walls, to provide a stable rail for advancing and aligning the prosthetic heart valve delivery device, allowing for precise deployment and fixation at the implantation site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a transcatheter-based delivery system is used to minimize invasiveness, then patient trauma is reduced, but precision in locating and orienting the prosthetic valve relative to native anatomy deteriorates
Solution Approach 1:
A guide member assembly with docking structure serves as an intermediary between the delivery system and native anatomy. The guide member is advanced through tortuous paths to the heart, and its distal docking structure interfaces with native structures (annulus, leaflets, or wall) to establish precise positioning. This intermediary enables minimally invasive delivery while achieving accurate valve alignment through the guide member's rail function.
2Ease of operation
If the delivery system navigates through tortuous paths to reach the heart, then minimally invasive access is achieved, but alignment of the valve with the native annulus deteriorates
Solution Approach 1:
The guide member is advanced and docked to native anatomy before the prosthetic valve is deployed. This preliminary positioning establishes a stable reference frame and alignment guide that ensures the subsequently delivered valve will be properly oriented with the native annulus, even after navigating through tortuous access paths.
Solution Approach 2:
The guide member assembly acts as a mediator that separates the navigation function from the deployment function. It navigates through tortuous paths to reach the heart and establishes precise positioning, while the delivery system then follows this established path for accurate valve placement, maintaining both minimally invasive access and precise alignment.
3Measurement precision
If a stable rail is introduced to improve alignment precision, then valve orientation improves, but device complexity increases
Solution Approach 1:
The delivery system is segmented into distinct functional components: a guide member assembly for navigation and positioning, and a separate delivery system for valve deployment. The guide member assembly itself is segmented into a shaft portion and a distal docking structure. This segmentation allows each component to be optimized for its specific function while working together to achieve precise valve orientation.
Solution Approach 2:
The guide member assembly serves multiple functions: it acts as a navigation rail through tortuous paths, provides a docking structure for stable positioning, and serves as a reference for valve alignment. By consolidating these functions into a single multi-functional component, the system achieves precise valve orientation without proportionally increasing overall complexity.
Data Source
AI summary
Methods of transcatheter delivery of a prosthetic heart valve. A distal region of a guide member assembly is advanced into a heart of a patient. The distal region is docked to native anatomy of the heart. A delivery device, including a collapsed prosthetic heart valve, is advanced over the docked guide member assembly. The collapsed prosthetic heart valve is located at an implantation site. The prosthetic heart valve is deployed from the delivery device, and then the delivery device is removed from the patient. At least a portion of the guide member assembly is removed from the patient. In some embodiments, the docking structure is docked to one or more of native mitral valve leaflets, chordae in the left ventricle, or walls of the left ventricle as part of a transseptal mitral valve delivery procedure.