Prosthetic Heart Valve Sealing Structure for Annular Gap Filling
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face issues with inaccurate deployment and anchoring, leading to complications such as valve migration, obstruction of the left ventricular outflow tract, and perivalvular leakage, which can reduce cardiac efficiency and cause severe adverse clinical outcomes due to anatomical variations and calcification of the native valve annulus.
Innovation Solution
The development of a prosthetic heart valve with a collapsible and expandable stent featuring a cuff that forms a sealing structure at the proximal end, which can expand to fill gaps between the implanted valve and the native valve annulus, reducing the need for excessive radial force and improving anchoring and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a collapsible prosthetic valve is deployed without a sealing structure, then the delivery profile is smaller and less invasive, but perivalvular leakage occurs due to gaps between the valve and native annulus
Solution Approach 1:
The cuff is prepared in advance with a surplus portion that will form the sealing structure. This preliminary preparation allows the sealing function to be activated during deployment without requiring complex real-time adjustments, resolving the contradiction between simple delivery and effective sealing.
Solution Approach 2:
The cuff transitions from a compressed state during delivery to an expanded state with deployed diameter greater than the stent diameter at the implant site. This dynamic transformation enables the sealing structure to adapt to anatomical variations and fill gaps between the valve and native annulus, eliminating perivalvular leakage while maintaining a simple delivery profile.
2Reliability
If excessive radial force is applied to expand the valve, then anchoring improves, but the risk of complications such as obstruction of the left ventricular outflow tract increases
Solution Approach 1:
The sealing force is concentrated locally at the proximal end of the stent where the cuff forms a sealing structure with diameter greater than the stent diameter. This localized anchoring provides reliable fixation without distributing excessive force throughout the entire valve structure, preventing complications such as obstruction of the left ventricular outflow tract while ensuring proper anchoring.
3Adaptability or versatility
If the valve is designed to accommodate anatomical variations and calcification, then sealing effectiveness improves, but the device complexity increases
Solution Approach 1:
The cuff is designed as a flexible structure with a surplus portion that can conform to irregular anatomical surfaces including calcified tissue. This flexible sealing structure adapts to anatomical variations and provides effective sealing without requiring complex mechanical adjustment mechanisms, resolving the contradiction between adaptability and device complexity.
Data Source
AI summary
A prosthetic heart valve for replacing a native valve includes a collapsible and expandable stent having a proximal end and a distal end, and a valve assembly disposed within the stent, the valve assembly including a plurality of leaflets and a cuff annularly disposed about the stent. The cuff includes a surplus portion capable of forming a sealing structure having a diameter greater than a diameter of the proximal end of the stent when deployed.