Presettable Artificial Biological Aortic Valve for Small Annuli
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Solution Overview
Problem
The challenge of mismatched valve sizes between artificial valves and patients, particularly in Chinese patients with small aortic valve annuli, leads to high cross-valve pressure differences, impaired hemodynamics, and increased left ventricular afterload, complicating surgeries and reducing long-term survival rates.
Innovation Solution
A presettable artificial biological aortic valve with a one-way limiting expandable design, allowing for initial implantation in a smaller size and subsequent expansion using a balloon to achieve a normal functional size, reducing complications and enabling interventional valve-in-valve treatments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a small-sized artificial valve is implanted to match the small aortic valve annulus, then the valve size matches the patient's anatomy, but the cross valve pressure difference increases and hemodynamics deteriorate
Solution Approach 1:
The valve is designed with a dynamic structure that allows it to transition from a compressed delivery state to an expanded functional state. The valve body includes expandable components that can be inflated post-implantation to increase the effective orifice area, transforming the valve from a static small size to a dynamically adjustable larger functional size, thereby resolving the contradiction between initial size matching and final hemodynamic performance
Solution Approach 2:
The valve utilizes parameter changes through balloon expansion to alter the physical dimensions of the valve orifice. By inflating a balloon within the valve structure, the internal diameter and cross-sectional area of the valve are increased, changing the flow parameters and reducing pressure gradient while maintaining the ability to initially match small annuli
2Reliability
If surgical annulus expansion is performed to increase valve size, then hemodynamic performance improves, but surgical complexity and complications increase
Solution Approach 1:
The valve is pre-configured with an expandable structure and delivery mechanism that allows the expansion action to be performed after implantation rather than during the complex surgical annulus expansion procedure. The balloon expansion capability is built into the valve design, enabling the hemodynamic improvement to be achieved through a simpler, less invasive post-implantation procedure
Solution Approach 2:
A balloon serves as an intermediary device that facilitates valve expansion without requiring direct surgical manipulation of the annulus or root. The balloon can be delivered through catheters and inflated within the valve structure, providing a mediated method to achieve size increase that avoids the complexity and risks of direct surgical expansion techniques
3Adaptability or versatility
If a small damaged valve is replaced with another small valve, then the valve matches the small annulus, but interventional valve-in-valve treatment becomes difficult and cross valve pressure difference remains high
Solution Approach 1:
The valve's dynamic expandability provides sufficient space and accessibility for future interventional valve-in-valve procedures. By allowing the valve to be expanded to a larger functional size, the effective orifice diameter increases, creating adequate room for subsequent interventional devices while maintaining initial implantability in small annuli
Solution Approach 2:
The valve is pre-expanded to a larger functional size that anticipates future interventional needs. This preliminary expansion creates sufficient space within the valve structure to accommodate future valve-in-valve interventions, preventing the space constraints that would otherwise limit treatment options in patients with small native valves
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 valve provides a normal functional state after expansion, reducing cross-valve pressure differences and enabling effective hemodynamic improvement, while avoiding surgical complications and facilitating future interventions.
Implementation Method 1
after the surgical implantation is completed, it can be rotated in one direction by balloon compression
Data Source
AI summary
The present invention discloses a presettable artificial biological aortic valve which comprises a valve seat (1), a valve leaflet stent (2) and three valve leaflets (3), wherein the valve seat (1) is a one-way limiting expandable annular metal seat; the head end of each seat body unit (4) is sequentially provided with a first rivet (7), a limiting protrusion (6) and a first long circular groove (5) from the outside to the inside; the tail end of each seat body unit (4) is sequentially provided with a second long circular groove (8), a second limiting hole (10) and a first limiting hole (9) matched with the limiting protrusion (6), and a second rivet (11) matched with the first long circular groove (5). The presettable artificial biological aortic valve has an original preset state and a normal use state after one-way limiting expansion.