Self-Expanding Stented Heart Valve Frames for Mitral Anchoring
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Solution Overview
Problem
Existing methods for replacing mitral valves are invasive and pose risks, and percutaneous mitral valve replacement faces unique challenges due to the mitral valve's distinct physical characteristics, requiring improved devices and procedures that minimize stress on the heart and ensure proper anchoring without obstructing the left ventricular outflow tract.
Innovation Solution
Development of a compressible and expandable stent frame with specific atrial and ventricular flares for mitral valve replacement, allowing percutaneous implantation and anchoring, using a self-expanding design with a fabric covering, and a delivery system that maintains the stent in a compressed state for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical methods are used to replace the mitral valve, then the valve replacement can be performed reliably, but the procedure is very invasive and requires opening the patient's chest
Solution Approach 1:
The replacement valve is nested within a delivery catheter in a compressed state, allowing it to be delivered percutaneously through the vascular system to the mitral valve location without requiring chest opening. The valve is then expanded from its nested state to its operational configuration at the implantation site.
Solution Approach 2:
A delivery catheter system serves as an intermediary to transport the compressed replacement valve through the vascular system to the mitral valve location, enabling percutaneous access and avoiding direct surgical exposure of the heart while maintaining reliable valve replacement capability.
2Reliability
If a stent frame with flares is used for mitral valve replacement, then secure anchoring is achieved, but there is risk of obstructing the left ventricular outflow tract
Solution Approach 1:
The stent frame features localized flares at specific positions (atrial flares extending from one side of the annular region and ventricular flares extending from another portion) that are strategically designed to engage with the annulus for secure anchoring while maintaining clearance from the left ventricular outflow tract, thus achieving both secure anchoring and avoiding obstruction.
Solution Approach 2:
The stent frame employs asymmetric flare configuration where atrial flares and ventricular flares are positioned at different locations and orientations around the annular region, allowing differential engagement with the annulus to achieve secure anchoring while preserving the geometry and patency of the left ventricular outflow tract.
3Adaptability or versatility
If the stent is designed to accommodate large orifices, then it can fit the mitral valve anatomy, but the device complexity increases
Solution Approach 1:
The stent frame is segmented into distinct components including a central annular region, atrial flares extending from one side, and ventricular flares extending from another portion, allowing each segment to be independently optimized for specific functions such as anchoring and outflow tract clearance while accommodating large mitral orifices.
Solution Approach 2:
The stent frame utilizes three-dimensional flare extensions from the annular region that project in different spatial dimensions, enabling the device to accommodate large orifices and complex annular geometries while maintaining structural integrity and avoiding outflow tract obstruction through strategic spatial positioning.
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
Enables minimally invasive mitral valve replacement with secure anchoring and minimal obstruction, reducing patient trauma and complications, while accommodating large or irregular orifices and ensuring the left ventricular outflow tract remains unobstructed.
Implementation Method 1
The stent frames of the invention are self-expanding
Data Source
Figure 1~4
Figure 5~9
Figure 10~13
AI summary
A stent frame (10) including an annular portion (12) having first and second ends, a central longitudinal axis, and a wire portion with at least two extending posts (18) the wire portion having a generally sinusoidal series of peaks and valleys between each of the at least two extending posts; an atrial portion (14) extending from the first end of the annular portion, wherein the atrial portion includes a plurality of flares (20) that extend radially outward relative to the longitudinal axis of the annular portion; and a ventricular portion (16) extending from the second end of the annular portion, wherein the ventricular portion includes at least one flare (24) that extends radially outward relative to the longitudinal axis of the annular portion.