Self-Actuating Sealing Legs 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 and perivalvular leakage, which can reduce cardiac efficiency and increase the risk of infection and damage to heart tissue, especially in patients with uneven calcification or bi-cuspid aortic valve disease.
Innovation Solution
A collapsible and expandable stent-based prosthetic heart valve with elongated legs that transition from an extended to a relaxed configuration, forming a sealing structure to securely anchor and seal within the native valve annulus, reducing the need for excessive radial force and minimizing gaps for improved fitment and reduced leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional collapsible prosthetic heart valves are used, then the valve can be delivered less invasively via catheter, but the deployment and anchoring accuracy deteriorates leading to perivalvular leakage and valve migration
Solution Approach 1:
The valve is divided into a stent component and separate anchoring legs. The legs are independently deployable elements that extend from the valve body to engage with the annulus, providing segmented anchoring that improves deployment accuracy while maintaining minimally invasive delivery through the collapsible stent- valve structure
Solution Approach 2:
The anchoring function is extended into a third dimension by deploying legs that project outward from the valve body. This dimensional extension allows the legs to engage with the annulus in a direction perpendicular to the valve plane, providing superior anchoring accuracy without compromising the minimally invasive delivery pathway
2Device complexity
If conventional prosthetic valves are used, then the valve structure is simple, but gaps form between the valve and native annulus causing perivalvular leakage
Solution Approach 1:
The sealing function is segmented from the main valve body by introducing separate anchoring legs with sealing portions. Each leg independently forms a sealing interface with the annulus, distributing the sealing function across multiple discrete contact points rather than relying on a single continuous seal, thereby eliminating gaps and preventing perivalvular leakage
Solution Approach 2:
The sealing portions at the tips of the anchoring legs are designed with enhanced local properties including increased radial strength and compliance. These localized quality enhancements allow the sealing portions to conform to irregularities in the annulus and maintain effective sealing contact, preventing perivalvular leakage without requiring complex modifications to the entire valve structure
3Reliability
If excessive radial force is applied to secure the valve, then the valve anchoring improves, but damage to heart tissue and calcification occurs
Solution Approach 1:
The anchoring force is segmented and distributed across multiple discrete leg-annulus contact points rather than applied as a single concentrated radial force. This segmentation allows the valve to achieve secure anchoring through distributed mechanical interlocking with the annulus, eliminating the need for excessive radial force that would cause tissue damage and calcification
Solution Approach 2:
The anchoring legs are designed with dynamic compliance, allowing them to flex and adapt to the contours of the annulus during deployment. This dynamic behavior enables the legs to achieve secure anchoring through controlled deformation and mechanical interlocking, reducing the peak radial forces required and minimizing damage to heart tissue and calcification
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 secure anchoring and sealing of the prosthetic heart valve, reducing the risk of perivalvular leakage and valve migration, thereby improving cardiac performance and reducing the risk of complications associated with improper fitment and calcification.
Implementation Method 1
a plurality of elongated legs configured to transition from an extended configuration to a relaxed configuration
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 including a plurality of leaflets, the valve assembly being disposed within the stent. The heart valve further includes a plurality of elongated legs each with a first end coupled to the stent and a free end, the elongated legs being configured to transition from an extended configuration to a relaxed configuration. A sealing portion connected to the plurality of legs forms a sealing structure when the legs transition to the relaxed configuration to reduce perivalvular leakage between the implanted valve and surrounding tissue.