Two-Stage Mitral Valve Anchor Assembly for Secure Percutaneous MR Reduction
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Solution Overview
Problem
Current percutaneous and minimally invasive mitral valve therapies face challenges in effectively reducing mitral regurgitation (MR) while preserving left ventricle geometry and avoiding complications such as stenosis, atrial fibrillation, and LV wall stress, with inadequate efficacy and high invasiveness being major issues.
Innovation Solution
A percutaneous mitral valve replacement system utilizing an anchoring structure with projections engaging the anatomical gutter of the mitral valve annulus, incorporating a tri-leaflet artificial valve and staged implantation to ensure secure anchoring, sealing, and minimal disruption of native valve function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical replacement or repair is performed, then mitral regurgitation is reduced, but invasiveness and risk are increased
Solution Approach 1:
The patent replaces the mechanical surgical approach with a percutaneous delivery system. The valve replacement device is delivered through a catheter inserted via the femoral artery, eliminating the need for open chest surgery, median sternotomy, and cardiopulmonary bypass. This substitution of delivery method directly reduces invasiveness and surgical risk while maintaining MR reduction efficacy.
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary tool to transport the valve replacement device to the mitral valve location. This intermediary enables percutaneous access to the heart valve, allowing treatment without direct surgical exposure and reducing the harmful factors of surgical invasiveness.
2Object-affected harmful factors
If percutaneous approach is used, then invasiveness is reduced, but anchoring reliability is worsened
Solution Approach 1:
The anchoring system is segmented into multiple independent anchoring legs that can be deployed separately. Each leg can be advanced through the annulus and engaged with the ventricular wall independently, providing distributed anchoring force. This segmentation enables reliable anchoring through a percutaneous approach by spreading the anchoring function across multiple discrete elements rather than requiring a single complex anchoring mechanism.
Solution Approach 2:
The patent employs preliminary actions in the anchoring process: first the delivery catheter is positioned, then the anchoring legs are deployed and engaged with the ventricular wall before the valve replacement is completed. This staged preliminary anchoring ensures secure fixation is established prior to final valve installation, compensating for the limitations of percutaneous access.
3Reliability
If valve replacement is performed, then MR is eliminated, but LV geometry and function may be compromised
Solution Approach 1:
The patent applies local quality by positioning the valve replacement device specifically at the mitral valve annulus rather than altering the entire ventricular structure. The anchoring legs are engaged locally with the ventricular wall at the annular level, providing support without requiring extensive modification of LV geometry. This localized approach eliminates MR while preserving overall ventricular function and geometry.
Solution Approach 2:
The patent changes the parameter of valve replacement methodology from surgical to percutaneous, which inherently reduces the impact on LV geometry. The percutaneous approach allows for precise positioning and anchoring without the need for extensive surgical manipulation of the ventricular structure, thereby maintaining LV function and geometry while achieving MR elimination.
4Reliability
If complex repair procedures are performed, then MR reduction is achieved, but procedure complexity and recurrence rate are increased
Solution Approach 1:
The patent extracts the complex surgical repair procedure and replaces it with a simplified percutaneous valve replacement system. By removing the need for complex surgical techniques and using a self-contained delivery and implantation system, the procedure complexity is reduced while maintaining effective MR reduction. The extracted complexity is contained within the device design rather than the procedural execution.
Data Source
AI summary
Systems and methods for medical interventional procedures, including approaches to valve implantation. In one aspect, the methods and systems involve a modular approach to mitral valve therapy.