Self-Expanding Stent with Anchoring Structures for Mitral Valve
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Solution Overview
Problem
Current transcatheter mitral valve replacement technologies face challenges due to the restrictive mitral annulus and complex anatomy, leading to difficulties in anchoring and deployment, which can result in complications such as left ventricular outflow obstruction and incomplete expansion, limiting their effectiveness compared to aortic valve replacements.
Innovation Solution
A self-expanding stent member with a biocompatible coating and anchoring structures that expand radially to securely anchor on the mitral valve annulus, allowing for a minimally invasive deployment through a catheter, mimicking the natural mitral valve geometry to ensure proper positioning and function.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a transcatheter mitral valve replacement system is used, then the invasiveness of the procedure is reduced, but the anchoring reliability and deployment completeness deteriorate due to the restrictive mitral annulus and complex anatomy
Solution Approach 1:
The stent member is divided into multiple segments or sections along its length, with each segment capable of independent expansion and anchoring. This segmentation allows the valve to adapt to the complex mitral annulus geometry while maintaining secure anchoring through distributed attachment points, resolving the contradiction between minimally invasive delivery and reliable anchoring.
Solution Approach 2:
The stent member incorporates radial expansion capability that transforms it from a compressed delivery state to a fully expanded functional state. This dimensional transformation allows the valve to achieve its final anchored configuration within the constrained mitral annulus space after passing through the catheter, enabling reliable anchoring despite the restrictive anatomy.
2Device complexity
If a self-expanding stent member is used, then the deployment complexity is reduced, but the risk of left ventricular outflow obstruction increases due to the restrictive mitral annulus
Solution Approach 1:
The stent member features varying structural properties along its length, with different sections optimized for specific functions: some sections have higher radial strength for anchoring in the mitral annulus, while other sections have lower profile characteristics to prevent obstruction of the left ventricular outflow tract. This local differentiation allows the device to achieve secure anchoring without causing harmful obstructions.
Solution Approach 2:
The stent member undergoes controlled parameter changes during deployment, transitioning from a low-profile compressed state through the catheter to a partially expanded anchoring state, and finally to a fully expanded functional state. This staged parameter change ensures that the valve achieves secure anchoring while maintaining adequate outflow tract clearance throughout the deployment process.
3Reliability
If anchoring structures are added to the stent member, then the anchoring reliability is improved, but the device complexity increases
Solution Approach 1:
The anchoring structures are merged with the stent frame itself, forming an integrated structure where the anchoring elements are continuous extensions or projections of the stent bars. This integration eliminates the need for separate anchoring components and simplifies the overall device architecture while maintaining reliable anchoring function in the mitral annulus.
Solution Approach 2:
The stent member bars serve multiple functions: they provide structural support for the valve leaflets, serve as the anchoring structures through their radial projections into the mitral annulus, and maintain the geometric shape of the valve. This multi-functionality reduces the need for additional specialized components, simplifying the device despite the enhanced anchoring 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 solution enables a safer, less invasive mitral valve replacement with reduced surgical risks and complications, facilitating quicker recovery and improved patient outcomes by securely anchoring the artificial valve within the mitral annulus, addressing the anatomical challenges faced by existing transcatheter systems.
Implementation Method 1
a self-expanding stent frame defining in its expanded position a central annular opening
Data Source
AI summary
In various embodiments, a stent member is provided. The stent member may include a self-expanding stent frame defining in its expanded position a central annular opening along a longitudinal axis, the opening extending from a first end to a second end of the stent frame. The stent member may include at least one anchoring structure extending radially outwards from the second end of the stent frame. The stent member may further include a biocompatible coating on the stent frame.