Posterior Mitral Valve Anchoring for LVOT-Sparing Implantation
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Solution Overview
Problem
Current treatments for mitral valve regurgitation face challenges such as difficulty in implantation, vascular complications, improper device securing, migration, and disruption of heart structures, leading to further complications like thrombosis and left ventricular outflow tract obstruction, and lack of flexibility for further intervention if treatment fails.
Innovation Solution
A prosthetic hemi-mitral valve apparatus with a frame, posterior leaflet, arm members, and anchoring leg, designed to approximate the native mitral annulus curvature, with adjustable features for secure attachment and coaptation, allowing for precise deployment and minimization of disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a transvascular approach with large catheters is used to implant a prosthetic mitral valve, then the valve can be implanted, but vascular complications occur and the atrial septum becomes difficult to traverse and close
Solution Approach 1:
The device is divided into multiple components: a delivery catheter, a prosthetic valve body, and separate anchoring elements. This segmentation allows the valve to be delivered through a catheter and then deployed in a controlled manner, reducing the size needed for insertion while maintaining implantability
Solution Approach 2:
The delivery catheter is designed with a predetermined configuration that allows it to navigate to the mitral valve location and deploy the valve components in a controlled sequence. The catheter is pre-configured with features to facilitate safe navigation and deployment, reducing vascular complications
2Reliability
If compression is applied to the aortic valve during implantation, then the mitral valve can be secured, but left ventricular outflow tract obstruction occurs
Solution Approach 1:
The anchoring elements are designed with specific local features that allow them to engage with the mitral valve annulus and leaflets without requiring compression of the aortic valve. The anchoring legs and arms are configured to provide secure attachment through localized engagement rather than global compression
Solution Approach 2:
The device incorporates curved arm members and annular sections that conform to the natural curvature of the mitral valve annulus. This curvature allows the device to be anchored securely while maintaining the geometry of the outflow tract and avoiding obstruction
3Ease of operation
If the mitral annulus is stretched during implantation, then the valve can be deployed, but mitral insufficiency is exacerbated
Solution Approach 1:
The device includes expandable elements that can be compressed during delivery and then expanded at the deployment site. This dynamic expansion allows the valve to be deployed without requiring stretching of the mitral annulus, as the expansion occurs within the existing annular dimensions
4Reliability
If chordae tendineae are disrupted during implantation, then the valve can be secured, but papillary muscles and left ventricle are affected
Solution Approach 1:
The device is designed to secure the valve through the mitral annulus and leaflets without requiring disruption of the chordae tendineae. The anchoring elements engage with the annular tissue and leaflets in a manner that preserves the chordal structures and their attachment to the papillary muscles
5Reliability
If arterial or conductive tissues are compressed during implantation, then the valve can be anchored, but A-V block occurs
Solution Approach 1:
The device incorporates flexible, thin-walled structures that can conform to the mitral valve anatomy without compressing adjacent arterial or conductive tissues. The flexible construction allows the valve to be anchored while maintaining the integrity of surrounding tissues
6Reliability
If a full prosthetic mitral valve is implanted, then mitral regurgitation is treated, but further intervention becomes complicated or impossible
Solution Approach 1:
The device is designed as a modular system with separable components that can be deployed in a controlled manner. This modular architecture allows for potential future interventions or adjustments while maintaining the primary function of treating mitral regurgitation
Solution Approach 2:
The device provides sufficient treatment of the mitral regurgitation through partial replacement or reinforcement of the valve structures, rather than complete replacement. This partial approach maintains some native valve functionality and creates flexibility for future interventions if needed
Data Source
AI summary
An implantable prosthetic posterior mitral valve is described where one variation generally includes a frame. A posterior leaflet having one or more scallops may be connected to the frame such that the scallops extend from the frame for coaptation against a native anterior leaflet when the frame is deployed. At least one arm member may be connected to the frame such that the arm member extends laterally in a curved configuration configured to approximate a curvature of a native mitral annulus when the frame is deployed, and an anchoring leg may be connected to the frame and extend in a superior direction from a posterior side of the frame and defines a capture region between the anchoring leg and the posterior side. The capture region may be sized to receive at least a portion of a native posterior leaflet in an elongated state when the frame is deployed.