Heart Valve Stent Cuff Assembly for Paravalvular Leak Sealing
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Solution Overview
Problem
Existing collapsible prosthetic heart valves suffer from paravalvular leakage due to gaps between the implanted prosthetic and patient tissue, resulting in reduced cardiac performance and inefficiencies.
Innovation Solution
A stent assembly for prosthetic heart valves with a cuff feature that includes members made of shape memory materials, which are tensioned to position the cuff sealing material around the stent upon deployment, reducing paravalvular leakage by forming a seal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a collapsible prosthetic heart valve is delivered via catheter, then invasiveness is reduced and surgical complexity decreases, but gaps between the prosthetic and patient tissue occur causing paravalvular leakage
Solution Approach 1:
The cuff is pre-formed with sealing material and attached to the stent framework before delivery. During deployment, the cuff is positioned in advance to engage with patient tissue, creating a seal that prevents paravalvular leakage before the valve becomes functional
Solution Approach 2:
The cuff acts as an intermediary component between the stent framework and patient tissue. It provides a sealing interface that bridges the gap between the rigid stent structure and the soft tissue, preventing leakage without requiring direct contact between the stent and tissue
2Volume of moving object
If the valve is collapsed to reduce circumferential size, then delivery apparatus size is minimized, but the sealing surface area is reduced leading to gaps with patient tissue
Solution Approach 1:
The valve is divided into functional segments: the collapsible stent framework for delivery, and the separate cuff component with sealing material. The cuff can be collapsed with the stent during delivery but expands independently to provide adequate sealing surface area when deployed
3Productivity
If the prosthetic valve is expanded to full operating size, then valve functionality is improved, but gaps between prosthetic and patient tissue increase causing paravalvular leakage
Solution Approach 1:
The cuff is constructed from flexible materials that can conform to the irregular surfaces of patient tissue. This flexible sealing barrier adapts to tissue contours even when the valve is fully expanded, maintaining contact and preventing leakage while preserving cardiac performance
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 stent assembly effectively minimizes paravalvular leakage by ensuring a secure fit of the prosthetic heart valve, enhancing cardiac performance and reducing inefficiencies.
Implementation Method 1
members made of shape memory materials, which are tensioned to position the cuff sealing material around the stent upon deployment
Data Source
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AI summary
A prosthetic heart valve having a cuff attached to a stent provides a seal for preventing paravalvular leakage. The cuff may be constructed from known sealing materials to fill in and around paravalvular leakage gaps, while continuously collapsing down into a low profile volume within the stent. The cuff is coupled circumferentially about the stent by members which may be in the nature of dimension and/or shape memory material having a tensioned and relaxed state. The members may be in the form of elongated elastic members or coiled members. When in the tensioned state, the cuff is located within the stent volume to provide a low profile prosthetic heart valve. Upon relaxing of the members, the cuff is pulled over the abluminal surface of the stent to form a cuff seal circumscribing the stent for preventing paravalvular leakage.