Prosthetic Heart Valve Frame Link Pivot Node Axial Translation
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Solution Overview
Problem
Existing prosthetic heart valves with radially expandable frames featuring pivoting struts can inadvertently cut or pinch the valve skirt, leaflets, and/or sutures due to a scissor-action between engaged edges of pivoting strut segments during dilation or collapse.
Innovation Solution
A prosthetic heart valve design that includes a radially expandable frame with a link and pivot nodes, where the second pivot node is slidably connected to the link, allowing it to move relative to the link along the axial direction, thereby preventing damage to the valve components during expansion and contraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If pivoting struts are used in the radially expandable frame, then the frame can mechanically pivot relative to one another at pivot nodes during dilation and collapse, but the scissor-action between engaged edges of pivoting strut segments can inadvertently cut or pinch the valve skirt, leaflets, and/or sutures
Solution Approach 1:
A sutureless mounting system is introduced as an intermediary between the pivoting struts and the valve components. The mounting system includes a mounting surface on the struts and a mounting element that couples the valve skirt and leaflets to this surface, eliminating direct contact between the pivoting strut edges and the vulnerable valve components, thus preventing cutting or pinching damage while maintaining mechanical pivoting functionality
2Productivity
If the radially expandable frame is dilated and collapsed repeatedly, then the prosthetic valve can be delivered and deployed, but the scissor-action between pivoting strut segments causes damage to the valve components
Solution Approach 1:
The sutureless mounting system serves as a protective intermediary layer that isolates the valve skirt and leaflets from the mechanical scissor-action of pivoting struts during repeated dilation and collapse cycles, maintaining component integrity while enabling efficient delivery and deployment
Solution Approach 2:
The mounting system divides the coupling function into separate elements: a mounting surface on the struts and a mounting element that attaches to the valve components, creating modular connections that reduce stress concentration and prevent damage during dynamic operation
3Strength
If traditional suture mounting is used to attach valve skirt and leaflets to the frame, then the components can be secured, but the sutures are vulnerable to being cut or pinched by the pivoting strut edges
Solution Approach 1:
The mounting element acts as an intermediary between the struts and the valve components, providing a secure attachment mechanism that distributes mechanical stresses away from vulnerable suture-like connections, eliminating the need for traditional sutures that are prone to cutting or pinching by pivoting strut edges
Data Source
AI summary
Prosthetic heart valves each includes a link extending along an axial direction and an axial frame. The axial frame includes a plurality of struts comprising a plurality of inner struts pivotally attached to a plurality of outer struts at a plurality of pivot nodes. A first pivot node of the plurality of pivot can be attached to the link and a second pivot node of the plurality of pivot nodes can move relative to the link in the axial direction. Methods of radially expanding a prosthetic heart valve can comprise radially expanding the radially expandable frame from a radially retracted orientation to a radially expanded orientation while the second pivot node axially translates relative to the link.