Mitral Valve Assembly Anchoring via Segmented Frame
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Solution Overview
Problem
Current percutaneous delivery methods for mitral valve replacement struggle to securely implant valves at the native mitral position without distorting the patient's anatomy, due to the thinner and smoother mitral valve annulus, which makes it difficult to anchor and secure the replacement valve effectively.
Innovation Solution
A mitral valve assembly with a self-expanding stent frame and leaflet assembly that includes a ball-shaped anchoring section with rows of cells and legs extending through the native mitral annulus, allowing secure anchoring within the left atrium without hooks or barbs, and a novel leaflet configuration for effective opening and closing, promoting proper mitral valve function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current percutaneous delivery methods are used to implant replacement mitral valves, then the valve can be delivered through catheter, but the valve cannot be securely anchored due to the thinner and smoother mitral valve annulus
Solution Approach 1:
The frame is divided into distinct functional segments: an anchoring section with multiple anchoring elements (hooks, bars, or protrusions) designed to engage with the mitral valve annulus, and a valve support section that holds the biological valve. This segmentation allows the anchoring portion to be optimized separately for secure engagement with the thinner mitral annulus while maintaining percutaneous deliverability.
Solution Approach 2:
Different portions of the frame are given different structural properties: the anchoring section features localized anchoring elements (hooks, bars, or protrusions) that provide enhanced grip on the annulus, while the valve support section maintains a configuration suitable for holding the biological valve. This local differentiation allows secure anchoring without compromising the overall percutaneous delivery capability.
2Reliability
If anchoring methods such as clamping on the annulus or hooking on the chordae are used, then the valve can be secured in place, but the patient's anatomy is altered and aortic valve function is affected
Solution Approach 1:
The harmful anchoring methods (clamping on the annulus or hooking on the chordae) are extracted and replaced with a new anchoring mechanism. The frame incorporates anchoring elements that engage with the annulus in a manner that provides stable positioning without the need to clamp or hook, thereby avoiding anatomical distortion and preserving aortic valve function.
Solution Approach 2:
The frame acts as an intermediary structure that provides a stable platform for the biological valve while engaging with the mitral valve annulus through specialized anchoring elements. This intermediary structure allows secure positioning without directly altering the patient's anatomy or affecting aortic valve function, as the anchoring is achieved through the frame's design rather than direct manipulation of cardiac structures.
3Reliability
If a one-piece replacement mitral valve is implanted by expanding the implant frame to achieve a tight fit, then the valve can be secured, but the mitral valve annulus anatomy is distorted
Solution Approach 1:
The frame is segmented into an anchoring section with discrete anchoring elements and a valve support section. This segmentation allows the anchoring elements to engage with the annulus at specific points without requiring the entire frame to be expanded tightly, thereby maintaining the natural geometry of the mitral valve annulus while achieving reliable anchoring.
Solution Approach 2:
The frame provides localized anchoring through specific anchoring elements (hooks, bars, or protrusions) rather than requiring uniform tight expansion of the entire frame. This local quality approach secures the valve in place while preserving the overall shape and geometry of the mitral valve annulus.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution enables secure percutaneous transcatheter placement of a biological valve at the native mitral position, minimizing anatomical distortion and ensuring effective valve function with reduced migration and impact on blood flow dynamics.
Implementation Method 1
The valve can have a resilient, self-expanding stent or frame that expands the valve to its functional size when it is advanced from a delivery sheath
Data Source
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AI summary
A heart valve assembly has a frame having an anchoring section defined by a plurality of rows of cells, with each cell defined by a plurality of struts that encircle each cell, and a pair of legs extending from the anchoring section. The assembly also includes a leaflet assembly that has a plurality of leaflets that are stitched to the legs. The heart valve assembly is delivered to the location of a native mitral annulus, and the anchoring section is deployed inside the left atrium such that the anchoring section is completely retained in the left atrium, and the legs and leaflets extend through the native mitral annulus.