Multi-Body Commissure Attachment Features for Prosthetic Valve Anchoring
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face issues such as perivalvular leakage, valve migration, mitral valve impingement, conduction system disruption, and coronary blockage due to uneven calcification and bi-cuspid disease, particularly when implanted without resecting native valve leaflets, leading to adverse clinical outcomes.
Innovation Solution
A prosthetic heart valve design featuring a collapsible and expandable stent with commissure features and eyelets arranged in rows and columns to distribute load, along with a valve assembly that includes leaflets connected via a suture pattern, allowing for improved load distribution and secure anchoring without excessive radial force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the valve is deployed to full operating size, then the sealing and anchoring capability is improved, but the ability to reposition becomes impossible or difficult
Solution Approach 1:
The valve deployment process is segmented into partial deployment and full deployment phases. The delivery system allows the valve to be partially deployed for positioning and evaluation, then fully deployed for optimal function. This segmentation resolves the contradiction by enabling repositioning during the partial deployment phase before the valve expands to a diameter larger than the sheath.
Solution Approach 2:
The valve is partially deployed and positioned in advance before final full deployment. This preliminary action allows the operator to evaluate valve position and make adjustments while the valve is still collapsible and can be resheathed, resolving the contradiction by performing repositioning actions before the valve expands to full size.
2Reliability
If excessive radial force is applied to achieve adequate sealing, then the sealing capability is improved, but harm to nearby anatomy and physiology increases
Solution Approach 1:
The valve design incorporates local quality variations in the stent structure, with different radial force characteristics at different locations. The stent provides adequate sealing force where needed while maintaining lower forces in regions where excessive force could harm nearby anatomy, such as the conduction system or coronary arteries.
Solution Approach 2:
The valve transitions from a collapsed state during delivery to an expanded state at implantation. This dynamic transformation allows the valve to achieve adequate sealing and anchoring only after proper positioning, reducing the risk of harm to nearby structures during the delivery and positioning phases.
3Ease of operation
If the valve is designed for minimal material volume to enable minimally invasive delivery, then the ease of delivery is improved, but the structural strength and sealing capability may be compromised
Solution Approach 1:
The valve is designed to be nested within a delivery sheath in a collapsed state, enabling minimally invasive delivery through small incisions. The nested configuration reduces the material volume required for delivery while maintaining the full structural strength and sealing capability of the expanded valve structure upon deployment.
Solution Approach 2:
The valve transitions from a low-dimensional collapsed state suitable for delivery through small access points to a high-dimensional expanded state that provides adequate structural strength and sealing capability. This dimensional transformation resolves the contradiction between minimal material volume for delivery and sufficient strength for function.
Data Source
AI summary
A prosthetic heart valve includes a collapsible and expandable stent extending in a longitudinal direction between an inflow end and an outflow end, the stent including a plurality of struts defining a plurality of cells, and a plurality of commissure attachment features disposed on the stent, each commissure attachment feature having a first end, a second end opposite the first end, and at least two bodies connected via one or more suspension struts, each of the at least two bodies having at least one eyelet.