Helical Mitral Valve Anchor for Stable Catheter Docking
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Solution Overview
Problem
Current catheter-based mitral valve replacement procedures face challenges in anchoring and retaining the prosthetic valve due to high cyclic loads, potential dislodgement, paravalvular leaks, and difficulty in maintaining proper orientation and size adjustment, especially for patients with complex anatomy or small arteries.
Innovation Solution
A helical anchor system comprising a coil guide catheter and a helical anchor is used to securely dock a prosthetic mitral valve, with features like shape memory material, anchoring arms, and expandable stents to stabilize the valve, prevent leaks, and adjust positioning.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a prosthetic valve is implanted using a minimally invasive transcateter approach, then patient trauma and hospital stay are reduced, but the risk of device migration and annulus rupture increases due to lack of direct visual control
Solution Approach 1:
The patent introduces a delivery system with visualizing components as an intermediary between the operator and the implantation site. The system includes a catheter with an imaging element that provides real-time visual feedback of the annulus and delivery device position, enabling accurate placement without direct surgical exposure. This mediator resolves the contradiction by maintaining minimally invasive access while adding visual control capability.
Solution Approach 2:
The patent replaces direct mechanical visual control (surgical exposure and direct observation) with an imaging-based feedback system. The imaging element captures visual information from within the heart, and this information is transmitted to a display device, substituting the need for direct mechanical access and visual inspection while maintaining positioning accuracy.
2Reliability
If a delivery system with visualizing component is used to improve positioning accuracy, then device migration risk is reduced, but the complexity and cost of the procedure increases
Solution Approach 1:
The delivery system is designed with multi-functionality to reduce overall complexity. The imaging element serves multiple purposes: visualizing the annulus, monitoring delivery device position, and guiding deployment. This universal component performs several functions that would otherwise require separate devices, thereby reducing system complexity while maintaining positioning accuracy.
Solution Approach 2:
The imaging element is nested within the delivery catheter, and the catheter is nested within the delivery system. This nested configuration allows the visualizing component to be integrated into the existing delivery architecture without requiring a completely separate complex system. The imaging element is positioned within the catheter lumen or on its surface, utilizing the same access pathway and deployment mechanism.
Data Source
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AI summary
Various systems, devices and methods associated with the placement of a dock or anchor (72) for a prosthetic mitral valve (120). The anchor (72) may take the form of a helical anchor having multiple coils (104, 108) and/or a stent-like structure. Various methods include different levels of minimal invasive procedures for delivering the prosthetic valve anchor (72) and prosthetic valve (120), as well as tissue anchors for plication or other purposes to the mitral valve position in the heart (14).