Prosthetic Heart Valve Leaflet Tension Line Design
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Solution Overview
Problem
Conventional collapsible prosthetic heart valves face challenges in implantation, particularly in patients with uneven calcification, bi-cuspid aortic valve disease, and valve insufficiency, leading to issues like perivalvular leakage, valve migration, and conduction system disruption due to the need for even leaflet calcification and proper coaptation.
Innovation Solution
A collapsible and expandable prosthetic heart valve design featuring a stent with commissure features and leaflets connected by fibers, allowing for adequate coaptation and reduced deflection under load, with reinforcement such as cords or fabric to enhance durability and coaptation performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional collapsible prosthetic heart valves are used, then the valve can be delivered minimally invasively, but the valve fails to provide proper coaptation in patients with uneven calcification, bi-cuspid aortic valve disease, and valve insufficiency
Solution Approach 1:
The valve employs a self-expanding stent that dynamically adapts to the annular geometry, allowing the valve to automatically adjust its shape and size to match the patient's anatomical variations, thereby achieving proper coaptation without requiring pre-resecting native leaflets
Solution Approach 2:
The valve design changes the expansion mechanism from balloon-dependent to self-expanding, allowing the stent to progressively open and conform to the annular shape, which enables better adaptation to uneven calcification and anatomical variations
2Ease of operation
If the native valve leaflets are not resected before implantation, then the procedure is less invasive, but perivalvular leakage and valve migration occur due to the stenotic leaflets remaining in place
Solution Approach 1:
The invention extracts the problematic native leaflets from the valve implantation process by designing a valve that can function independently of them, using a self-expanding stent that creates its own sealing mechanism without requiring removal of the native tissue
Solution Approach 2:
The self-expanding stent acts as an intermediary structure that mediates between the native valve anatomy and the prosthetic valve function, allowing the valve to be implanted over the native leaflets without requiring their removal, while still achieving proper sealing through the stent's expansion and conforming to the annular geometry
3Reliability
If the valve is designed to accommodate anatomical variations, then coaptation improves, but the device complexity increases
Solution Approach 1:
The self-expanding stent provides dynamic adaptability to anatomical variations through its progressive expansion mechanism, allowing the valve to automatically adjust its shape and size to match the patient's annular geometry without requiring complex pre-planned configurations or multiple components
Solution Approach 2:
The stent design serves multiple functions simultaneously: it provides structural support, enables self-expansion, adapts to anatomical variations, and creates the sealing surface, thereby reducing the need for separate components and simplifying the overall device structure
Data Source
AI summary
A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end. The heart valve further includes a plurality of commissure features disposed on the stent, and a collapsible and expandable valve assembly, the valve assembly including a plurality of leaflets connected to the plurality of commissure features, each of the plurality of leaflets having a free edge and being configured to have a tension line aligned near the free edge to prevent backflow.