Self-Actuating Valve Sealing Structure for Paravalvular Leak Reduction
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face challenges such as inaccurate deployment and anchoring, leading to complications like valve migration, perivalvular leakage, and reduced cardiac efficiency due to gaps between the implanted valve and native valve annulus, especially in patients with uneven calcification or unresected native leaflets.
Innovation Solution
The design incorporates a collapsible prosthetic heart valve with elongated legs and a sealing portion that transitions from an extended to a relaxed configuration, forming a sealing structure upon deployment, which fills gaps between the valve and native annulus, reducing leakage and improving anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional collapsible prosthetic heart valves are deployed, then the valve can be implanted less invasively via catheter delivery, but inaccurate deployment and anchoring occur leading to valve migration and perivalvular leakage
Solution Approach 1:
The sealing portion is divided into multiple elongated legs that can independently transition from extended to relaxed configurations. This segmentation allows each leg to independently conform to anatomical variations and calcified tissues, improving deployment accuracy and anchoring reliability while maintaining the minimally invasive delivery approach
Solution Approach 2:
The sealing portion transitions from a constrained extended configuration during delivery to a relaxed configuration upon deployment. This dynamic transformation allows the sealing structure to adapt to the native valve annulus geometry, eliminating gaps and preventing perivalvular leakage while maintaining ease of catheter delivery
2Productivity
If conventional prosthetic valves are deployed, then valve replacement can be performed, but gaps form between the implanted valve and native valve annulus causing perivalvular leakage
Solution Approach 1:
The sealing portion is designed with local quality variations through its elongated legs that can independently adjust to local anatomical conditions. This allows the sealing structure to conform to uneven calcification and unresected native leaflets at specific locations, filling gaps and preventing perivalvular leakage while maintaining overall valve replacement functionality
Solution Approach 2:
The sealing portion functions as a flexible structure that transitions from an extended to relaxed configuration, allowing it to conform to the irregular surface of the native valve annulus. This flexibility enables the sealing portion to eliminate gaps caused by anatomical variations and calcified tissues, preventing perivalvular leakage while maintaining valve replacement capability
3Stability of the object's composition
If conventional valves are anchored, then the valve can be secured in place, but excessive radial force is required leading to tissue damage and reduced cardiac efficiency
Solution Approach 1:
The elongated legs dynamically transition from an extended configuration during delivery to a relaxed configuration upon deployment, providing anchoring forces that adapt to the native tissue. This dynamic anchoring mechanism secures the valve in place while distributing forces evenly, preventing tissue damage and maintaining cardiac efficiency
Solution Approach 2:
The sealing portion changes its physical parameters from a constrained extended state to a relaxed state with different dimensional characteristics. This parameter change allows the structure to provide adequate anchoring forces for valve stability while conforming to anatomical variations, preventing both valve migration and tissue damage
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 enhances the accuracy of valve implantation, reduces the risk of migration and leakage, and improves cardiac efficiency by securely anchoring the valve without excessive radial force, accommodating anatomical variations and calcified tissues.
Implementation Method 1
each of the legs having a first end coupled to the stent and a second free end, the elongated legs being configured to transition from an extended configuration to a relaxed configuration
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
A prosthetic heart valve (300) for replacing a native valve includes a collapsible and expandable stent (306) having a proximal end (302) and a distal end (304), and a valve assembly (308) including a plurality of leaflets (310), the valve assembly (308) being disposed within the stent. The heart valve (300) further includes a first plurality of elongated legs (320) coupled to the stent (306) and transitionable from an extended configuration to a relaxed configuration. A first sealing portion (322) connected to the first plurality of legs (320) forms a sealing structure (350) when the legs (320) transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.