Prosthetic Heart Valve Cuff Structure for Paravalvular Leak Mitigation
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Solution Overview
Problem
Collapsible prosthetic heart valves experience paravalvular leaks due to imperfect sealing between the implanted valve and native tissue, leading to retrograde blood flow and reduced cardiac performance.
Innovation Solution
The prosthetic heart valve incorporates additional cuffs and fingers that extend radially outward to fill gaps between the implanted valve and native tissue, enhancing sealing and minimizing leaks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a simple stent structure is used, then device complexity is reduced and ease of manufacture is improved, but sealing performance deteriorates leading to paravalvular leaks
Solution Approach 1:
The sealing system is segmented into multiple independent components: a first cuff attached to the stent, a second cuff positioned radially outward of the first cuff, and multiple fingers extending between them. Each segment contributes to the overall sealing function, allowing the complex sealing task to be divided into manageable parts that can be manufactured and assembled separately.
Solution Approach 2:
The patent transitions from a single-plane sealing approach to a multi-dimensional sealing structure. The second cuff is positioned radially outward of the first cuff, creating a layered sealing arrangement. Fingers extend radially outward to position the second cuff, adding radial dimensionality to the sealing mechanism and improving sealing coverage without significantly increasing manufacturing complexity.
2Reliability
If additional sealing components are added, then sealing performance is improved, but device complexity increases
Solution Approach 1:
Multiple sealing functions are merged into a coordinated system where the first cuff, second cuff, and fingers work together as an integrated sealing mechanism. The first cuff provides initial sealing against the stent, while the second cuff extends the sealing barrier radially outward. The fingers serve dual purposes: positioning the second cuff and providing additional sealing coverage, thereby merging positioning and sealing functions into a single structural element.
Solution Approach 2:
The fingers serve multiple functions: they extend radially outward to position the second cuff at the appropriate radial distance, they provide structural support for the second cuff, and they contribute to the overall sealing geometry. This multi-functionality reduces the need for separate dedicated components, thereby managing device complexity while achieving improved sealing performance.
Data Source
AI summary
A prosthetic heart valve includes a collapsible stent and a valve assembly disposed within the stent. A first cuff is disposed adjacent the stent. A second cuff having a distal edge facing the outflow end of the stent is disposed about the stent radially outward of the first cuff and the stent. The stent may include a plurality of fingers each having a first end coupled to a corresponding cell of the stent and a free end adapted to extend radially outward of the corresponding cell. The distal edge of the second cuff may be coupled to the fingers at spaced locations around the circumference of the stent to position the distal edge radially outward from the corresponding cells at the spaced locations. Various stent struts may be tapered to reduce the stent circumference in the collapsed condition, and to improve the fatigue resistance and/or bendability of the stent.