Prosthetic Heart Valve Leaflet Design for Coaptation
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Solution Overview
Problem
Existing prosthetic valves face challenges in achieving proper coaptation and minimizing pressure gradients across a wide range of valve diameters, with single leaflet designs often resulting in either high pressure gradients during systole or malcoaptation during diastole.
Innovation Solution
A prosthetic valve design featuring an annular frame with leaflets that have an upper material portion offsetting the leaflet free edge from commissures, providing material slack for radial extension during coaptation, and a delivery apparatus for implanting the valve using a handle and actuator to release the valve at the implantation site.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the size of the leaflets is increased to ensure proper coaptation during diastole, then coaptation is improved, but pressure gradients increase during systole as the leaflets form folds and ripples
Solution Approach 1:
The leaflet is divided into multiple functional zones: a free edge zone for coaptation, a mid-portion with folds/ripples for flexibility, and an attachment zone for structural support. This segmentation allows each zone to perform its specific function optimally without compromising others.
Solution Approach 2:
The leaflet design incorporates dynamic elements including folds and ripples in the mid-portion that can deform during cardiac cycles, allowing the leaflet to adapt its shape and configuration based on whether it is in systole or diastole, optimizing performance for each phase.
2Object-generated harmful factors
If the size of the leaflets is reduced to minimize pressure gradients during systole, then pressure gradients are improved, but malcoaptation occurs during diastole
Solution Approach 1:
The leaflet is divided into multiple functional zones: a free edge zone for coaptation, a mid-portion with folds/ripples for flexibility, and an attachment zone for structural support. This segmentation allows each zone to perform its specific function optimally without compromising others.
Solution Approach 2:
The leaflet design incorporates dynamic elements including folds and ripples in the mid-portion that can deform during cardiac cycles, allowing the leaflet to adapt its shape and configuration based on whether it is in systole or diastole, optimizing performance for each phase.
3Device complexity
If a single leaflet design is used across a wide range of valve diameters, then device complexity is reduced, but achieving proper coaptation and minimizing pressure gradients becomes challenging
Solution Approach 1:
The leaflet design is engineered to be universal across multiple valve sizes (20mm to 30mm) while maintaining optimal performance. The standardized design with folds, ripples, and specific dimensional relationships allows the same basic structure to function properly across different valve diameters without requiring size-specific design variations.
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 design enables proper coaptation across a wider range of valve sizes with minimized pressure gradients, allowing for effective blood flow regulation and reduced risk of malcoaptation or excessive pressure.
Implementation Method 1
an upper material portion of a select height connected to the leaflet free edge... the upper material portion contributes a material slack respectively at the opposite ends of the leaflet free edge that extends a radial reach of the leaflet free edge for coaptation
Data Source
AI summary
A prosthetic valve includes an annular frame and a valvular structure mounted within the annular frame. The valvular structure comprises a plurality of leaflets defining a plurality of commissures coupled to the annular frame. Each leaflet includes a leaflet free edge that is offset in a downstream direction from the commissures by side edges that are not attached to the frame. A material portion of the leaflet disposed between the side edges contributes a material slack that extends a radial reach of the leaflet free edge for coaptation. The prosthetic valve can be releasably coupled to a delivery device to form a delivery apparatus. The prosthetic valve can be delivered to a selected implantation site by the delivery apparatus and released at the implantation site by a handle of the delivery device.