Balloon Expandable Valve Commissure Attachment Features
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Solution Overview
Problem
Existing prosthetic heart valves for transcatheter aortic valve replacement (TAVR) and transcatheter mitral valve replacement (TMVR) face challenges in minimizing paravalvular leakage (PV) and ensuring precise alignment and anchoring within the native valve annulus.
Innovation Solution
The prosthetic heart valve design incorporates a collapsible and expandable stent with commissure attachment features, a valve assembly with a cuff and leaflets, and commissure regions with a dual-layer fabric structure to reduce stress on the leaflets and enhance sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a balloon-expandable valve is used for TAVR/TMVR, then the valve can be delivered via catheter in a minimally invasive procedure, but the valve may not achieve precise alignment and anchoring within the native valve annulus
Solution Approach 1:
The stent is divided into multiple commissure attachment features, each with specific geometric configurations (struts forming apertures). These segmented structures provide discrete anchoring points that enhance alignment precision while maintaining the overall balloon-expandable delivery system
Solution Approach 2:
The commissure attachment features are pre-formed on the stent with specific geometric configurations before delivery. These pre-configured features ensure precise alignment and anchoring are achieved automatically upon balloon expansion, without requiring additional adjustment steps
2Ease of operation
If a balloon-expandable valve is used for TAVR/TMVR, then the valve can be delivered via catheter in a minimally invasive procedure, but paravalvular leakage may occur due to imperfect sealing
Solution Approach 1:
The stent includes multiple commissure attachment features distributed around the circumference, creating multiple sealing zones. This segmentation allows the valve to achieve uniform apposition to the native annulus, reducing paravalvular leakage while maintaining minimally invasive delivery capabilities
Solution Approach 2:
The commissure attachment features have specific local geometric configurations (struts forming apertures with particular dimensions and orientations) that optimize sealing at critical commissure regions. This local quality enhancement addresses leakage-prone areas without compromising the overall minimally invasive delivery system
3Reliability
If fabric is wrapped around struts to form commissure regions, then stress on leaflets is reduced and sealing is enhanced, but the device complexity increases
Solution Approach 1:
The fabric commissure regions are integrated directly with the stent struts, merging the sealing function with the structural support function. This combination reduces device complexity compared to having separate sealing components, while still achieving enhanced sealing performance and reduced leaflet stress
Solution Approach 2:
The fabric is pre-formed and attached to the struts in specific configurations before final assembly. This preliminary preparation simplifies the overall construction process and reduces complexity during manufacturing, while ensuring optimal sealing performance in the final product
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
This design effectively reduces paravalvular leakage and improves the precision of valve alignment and anchoring, leading to better functional outcomes and durability of the prosthetic heart valve.
Implementation Method 1
the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped condition into an expanded or deployed condition
Data Source
AI summary
In some examples, a prosthetic heart valve includes a collapsible and expandable stent comprising a plurality of commissure attachment features, each of the plurality of commissure attachment features including a generally rectangular body having a top strut, a bottom strut and two sides struts, and defining a central aperture, a valve assembly comprising a cuff and a plurality of leaflets, and a plurality of commissure regions, each of the plurality of commissure regions including a fabric folded over the top strut of one of the plurality of commissure attachment features to form an inner fabric layer and an outer fabric layer, and one or more sutures coupling the inner fabric layer and the outer fabric layer via the central aperture.