Variable Diameter Stent for Minimally Invasive Valve Delivery
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Solution Overview
Problem
Existing valve replacement stents face challenges in being crimped to small diameters without damaging the valve, and they often require larger skin incisions and more invasive procedures for delivery and implantation.
Innovation Solution
A valve replacement device featuring a stent component that is radially compressible and expandable, combined with valve leaflets made of pericardium tissue, allowing for crimping to diameters less than 18 French without damage and facilitating minimally invasive delivery through smaller skin incisions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the stent valve is crimped to a small diameter for transvascular delivery, then the invasiveness of the procedure is reduced, but the valve may be damaged due to high strains
Solution Approach 1:
The stent is designed with variable diameter sections that allow different parts of the stent to have different diameters in the compressed state. This enables the stent to be crimped to a smaller overall diameter for delivery while maintaining adequate space for the valve in critical sections, thereby reducing crimping strains on the valve while still achieving minimally invasive delivery through smaller incisions
Solution Approach 2:
The stent is divided into multiple sections with different functional requirements. The first and second sections have smaller diameters for delivery through the catheter, while the intermediate section maintains a larger diameter to accommodate the valve element and reduce crimping damage. This segmentation allows the stent to meet both delivery and valve protection requirements simultaneously
2Ease of operation
If the stent valve is crimped to a small diameter for delivery through the aortic arch, then transvascular delivery becomes feasible, but the anchoring reliability over the aortic annulus may be compromised
Solution Approach 1:
The stent employs variable diameter sections where the first and second sections are compressed to smaller diameters for navigation through the aortic arch, while the intermediate section maintains a larger diameter that ensures proper anchoring over the aortic annulus. This parameter variation allows the stent to achieve both deliverability and anchoring reliability
Solution Approach 2:
The stent is designed to transition from a compressed delivery state to an expanded functional state. In the compressed state, the variable diameter sections allow passage through narrow vessels. Upon deployment, the stent expands to provide adequate radial force for secure anchoring over the aortic annulus, with the intermediate section providing enhanced anchoring capability
3Ease of operation
If a smaller skin incision is used for delivery, then the invasiveness of the procedure is reduced, but the diameter of the delivery system is constrained
Solution Approach 1:
The stent's variable diameter design allows it to be compressed to a smaller overall diameter, enabling delivery through smaller catheters that can pass through smaller skin incisions. The intermediate section maintains adequate diameter for valve accommodation even in the compressed state, allowing the entire assembly to fit through constrained delivery pathways while preserving functional requirements
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 device enables reliable placement and tight anchoring over the aortic annulus, reducing the risk of valve damage during crimping and allowing for less invasive procedural approaches.
Implementation Method 1
a stent component (20) configured to be radially compressible into a compressed state and expandable into a functional state
Data Source
AI summary
A device for heart valve replacement comprises a valve component having at least two valve leaflets preferably made of pericardium tissue. Each valve leaflet includes at least two tabs. The device further includes a stent component configured to be radially compressible into a compressed state and expandable into a functional state. The stent component comprises a first end, a second end and at least one intermediate section arranged between said first and said second end. The intermediate section has at least two commissural posts generally aligned parallel to an axis spanning from the first end to the second end. The commissural posts are formed in the shape of a wishbone.