Modular Heart Valve Assembly for Mitral Regurgitation Treatment
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Solution Overview
Problem
Current medical technologies face challenges in effectively reducing mitral regurgitation (MR) through minimally invasive methods without causing negative physiologic consequences, such as stenosis, LV wall stress, and atrial fibrillation, and struggle to preserve left ventricular geometry, especially in patients with secondary or functional MR.
Innovation Solution
A heart valve assembly system with an anchor and valve assembly designed for percutaneous implantation, featuring a staged approach with a secure anchoring mechanism and a valve structure that maintains native valve function, includes annular ridges, a tapered portion for tissue ingrowth, and multiple leaflets to ensure durable and physiologically appropriate valve replacement, allowing for precise positioning and adaptation to various valve anatomies.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a percutaneous valve assembly system is implanted to treat mitral regurgitation, then the invasiveness of the procedure is reduced, but the risk of causing negative physiologic consequences such as stenosis and LV wall stress increases
Solution Approach 1:
The valve assembly is divided into separate components including a valve body, leaflets, and anchoring structure that can be delivered independently through catheters and assembled in situ, reducing the invasiveness of the procedure while maintaining physiological function
Solution Approach 2:
The valve assembly acts as an intermediary device that redirects blood flow away from the regurgitant mitral valve, treating the regurgitation without requiring direct manipulation or replacement of the native valve structures, thereby reducing procedural invasiveness
2Reliability
If the valve assembly is designed to reduce mitral regurgitation effectively, then MR reduction is achieved, but the risk of causing stenosis and LV wall stress increases
Solution Approach 1:
The valve assembly is designed with localized flow redirection capabilities that target specifically the regurgitant jet while preserving normal forward flow through the left ventricle, achieving MR reduction without causing stenosis or increasing LV wall stress
Solution Approach 2:
The valve assembly provides partial occlusion of the mitral valve orifice to redirect flow rather than complete occlusion, which is sufficient to treat regurgitation while maintaining adequate forward flow and avoiding stenosis
3Manufacturing precision
If a staged implantation approach is used with anchor and valve assembly, then positioning precision is improved, but the device complexity increases
Solution Approach 1:
The implantation process is segmented into distinct stages: first deploying an anchor structure to establish a stable foundation, then sequentially adding the valve body and leaflets, which improves positioning precision while managing complexity through modular assembly
Solution Approach 2:
The anchor structure is deployed in advance to establish a secure foundation and predetermined positioning before the valve assembly is attached, ensuring precise final position while allowing the valve components to be simpler in design
Data Source
AI summary
Heart valve assembly systems and methods configured for medical interventional procedures. In one aspect, the methods and systems involve a modular approach to treatment.