Bowed Runner Valve Assembly for Paravalvular Leak Sealing

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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 paravalvular leakage, which reduce cardiac efficiency and require additional procedures.

Innovation Solution

The use of bowed runners on the stent of the prosthetic heart valve, which transition from a linear to a bowed configuration during expansion, provide additional support and sealing by pressing a cuff against the native valve annulus, reducing gaps and enhancing the seal.

Engineering Contradictions & Design Principles

VSEngineering 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 valve deployment and anchoring are inaccurate leading to paravalvular leakage and valve migration

Engineering Contradiction:

Improveless invasive deliveryVSAvoiddeployment accuracy

Core Design Contradiction:

Ease of operationVSReliability

Solution Approach 1:

The stent is divided into multiple cells with individual runners, allowing each segment to independently bow outward and provide localized sealing at different positions around the valve annulus, improving overall deployment accuracy and anchoring reliability

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The runners are designed to bow outward in a curved configuration when the stent expands, creating a rounded sealing surface that conforms to the native valve annulus geometry, thereby improving the seal and reducing paravalvular leakage

Inventive Principle:

Principle #14Spheroidality (Curvature)

2Reliability

If the stent expands to full operating size, then the valve functions properly, but gaps form between the valve and native valve annulus causing paravalvular leakage

Engineering Contradiction:

Improvevalve functionVSAvoidparavalvular leakage

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The runners bow outward in a curved configuration when the stent expands, creating a rounded sealing surface that conforms to the native valve annulus geometry, thereby improving the seal and reducing paravalvular leakage

Inventive Principle:

Principle #14Spheroidality (Curvature)

Solution Approach 2:

Each runner is positioned at specific locations around the valve annulus and is designed to bow outward independently, providing localized sealing at critical gaps where leakage most commonly occurs, while maintaining overall valve function

Inventive Principle:

Principle #3Local quality

3Reliability

If runners are added to provide sealing support, then paravalvular leakage is reduced, but the device complexity increases

Engineering Contradiction:

Improvesealing performanceVSAvoidstent structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The runners are integrated directly into the stent structure as continuous elements formed from the same material, combining the sealing function with the structural framework rather than adding separate discrete components, thereby improving sealing performance while minimizing the increase in device complexity

Inventive Principle:

Principle #5Merging (Combining)

Data Source

PatentUS20250359989A1Bowed Runners and Corresponding Valve Assemblies for Paravalvular Leak Protection

Publication Date: 2025.11.27 ST JUDE MEDICAL CARDILOGY DIV INC

AI summary

A prosthetic heart valve for replacing a native valve includes a stent extending between a proximal end and a distal end and including a plurality of struts forming cells, the stent having a collapsed condition and an expanded condition. At least one runner is coupled a cell, the at least one runner being configured to transition from a first configuration to a second configuration when the stent moves from the collapsed condition to the expanded condition, the at least one runner projecting radially outwardly from the cell in the second configuration. A valve assembly is disposed within the stent, the valve assembly including a plurality of leaflets, a cuff at least partially disposed on a luminal surface of the stent, and a covering material disposed on an abluminal surface of the stent and covering the at least one runner in the second configuration.