Self-Expanding Heart Valve Stent with Cuff Sealing
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Solution Overview
Problem
Current prosthetic heart valves often experience paravalvular leakage due to inaccurate placement and anatomical variations, leading to reduced cardiac efficiency and increased risk of infection during removal, which complicates procedures and affects coronary perfusion.
Innovation Solution
A collapsible and expandable stent with a unique configuration featuring commissure features, struts forming cells, and a cuff extending over multiple rows of cells, including undersized cells to enhance sealing while maintaining coronary perfusion by allowing unimpeded blood flow to coronary arteries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic heart valve is placed to achieve secure anchoring and sealing, then paravalvular leakage is reduced, but coronary perfusion may be compromised due to anatomical variations and placement constraints
Solution Approach 1:
The stent incorporates cells of varying sizes at different locations: smaller cells in the annulus section for sealing and larger cells in the aortic section for coronary perfusion. This spatial variation in cell size allows the structure to perform different functions in different regions, resolving the contradiction between sealing and perfusion.
Solution Approach 2:
The stent is divided into distinct functional sections (annulus section with smaller cells for sealing, aortic section with larger cells for perfusion, and transition section connecting them). This segmentation allows each section to be optimized for its specific function while working together as an integrated structure.
2Ease of operation
If a collapsible valve is delivered invasively via catheter, then surgical invasiveness is reduced, but placement precision and sealing accuracy deteriorate
Solution Approach 1:
The stent transitions from a collapsed delivery state to an expanded deployed state, allowing it to be delivered through a catheter and then expand to its functional configuration. This dynamic transformation enables minimally invasive delivery while achieving precise placement and sealing at the implant site.
Solution Approach 2:
The self-expanding stent uses its own elastic memory to expand and deploy at the implant site without requiring external balloon expansion. This self-service mechanism simplifies the deployment process and reduces the complexity of the delivery system while maintaining placement accuracy.
3Reliability
If the cuff is extended to cover more rows of cells for improved sealing, then paravalvular leakage is reduced, but the device complexity and manufacturing difficulty increase
Solution Approach 1:
The cuff is designed to extend over multiple rows of cells with varying sizes, allowing it to perform multiple functions: sealing against the annulus using smaller cells and maintaining coronary perfusion using larger cells. This multi-functionality reduces the need for separate components while achieving both sealing and perfusion goals.
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 effectively reduces paravalvular leakage and maximizes coronary perfusion by ensuring secure anchoring and optimal blood flow, minimizing the need for valve removal and associated risks, while maintaining cardiac efficiency.
Implementation Method 1
For self-expanding valves, on the other hand, the stent automatically expands as the sheath covering the valve is withdrawn
Data Source
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AI summary
A prosthetic heart valve includes a collapsible and expandable stent including a plurality of struts forming cells, the stent having a proximal end, a distal end, an annulus section adjacent the proximal end, an aortic section adjacent the distal end, and a transition section disposed between the annulus section and the aortic section, the aortic section having a larger diameter than the annulus section. The heart valve further includes a valve assembly disposed entirely in the annulus section of the stent for controlling the flow of blood through the stent, the valve assembly including a plurality of leaflets, and a cuff, the cuff being disposed on a surface of the stent and extending fully over at least two rows of cells of the stent.