Mitral Valve Coaptation Device with Variable Stent Rigidity
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Solution Overview
Problem
Current percutaneous technologies for treating mitral valve regurgitation do not offer the same efficacy as surgical repairs and face challenges such as asymmetrical mitral annulus shape, left ventricular outflow obstruction, and paravalvular leaks, necessitating a more effective and minimally invasive solution.
Innovation Solution
A prosthetic mitral valve coaptation enhancement device with a self-expandable stentframe and valve element, designed to fit within the native mitral valve region, featuring a sealing section that adapts to the coaptation zone and a valve-bearing section with higher radial rigidity, along with anchoring elements for secure placement, to reduce regurgitation by filling the space between malcoapting leaflets without expanding the valve further.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If percutaneous technologies are used to treat mitral valve regurgitation, then minimally invasive treatment is achieved, but treatment efficacy is reduced compared to surgical repairs
Solution Approach 1:
The device is divided into distinct functional sections: a sealing section with lower radial rigidity to adapt to the coaptation zone, and a valve-bearing section with higher radial rigidity to maintain valve function. This segmentation allows each section to perform its specific function optimally while maintaining overall device effectiveness in a minimally invasive approach
Solution Approach 2:
Different sections of the device have different radial rigidity properties tailored to their specific functions. The sealing section has lower radial rigidity to conform to the asymmetric mitral annulus shape and coaptation zone, while the valve-bearing section has higher radial rigidity to support valve element function, thereby achieving both minimally invasive delivery and effective treatment
2Reliability
If the device is designed to fit the asymmetric mitral annulus shape, then better sealing is achieved, but device complexity increases
Solution Approach 1:
The stentframe is designed with dynamic radial rigidity characteristics that allow it to adapt to the asymmetric mitral annulus shape. The sealing section's lower radial rigidity enables it to flex and conform to the natural asymmetric geometry of the mitral valve, achieving effective sealing without requiring a complex custom-shaped structure
Solution Approach 2:
The device utilizes parameter changes in radial rigidity along its length, with the sealing section having lower radial rigidity to adapt to the coaptation zone geometry. This gradient in mechanical properties allows the device to match the asymmetric mitral annulus shape while maintaining a relatively simple overall structure
3Reliability
If the valve-bearing section has higher radial rigidity, then valve function is maintained, but the device cannot adapt to the coaptation zone shape
Solution Approach 1:
The device is divided into functional sections with different mechanical properties: the sealing section has lower radial rigidity to adapt to the coaptation zone shape, while the valve-bearing section has higher radial rigidity to maintain valve function. This segmentation resolves the contradiction by allowing each section to have the mechanical properties needed for its specific function
Solution Approach 2:
Different sections of the stentframe have locally optimized radial rigidity properties. The sealing section's lower radial rigidity enables adaptation to the coaptation zone, while the valve-bearing section's higher radial rigidity ensures proper valve function, with each section's properties tailored to its specific role
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 effectively reduces or eliminates mitral regurgitation by creating a unidirectional flow, minimizing the pressure gradient between the left atrium and ventricle, and supports native valve function without replacing it, thus improving heart efficiency and reducing traumatic impact.
Implementation Method 1
the stentframe being radially compressible to a radially compressed state for delivery into the heart and self-expandable from the compressed state to a radially expanded state
Implementation Method 2
the shape of the sealing section of the main body, in the compressed state, has a form that is adapted to the coaptation zone of the native mitral valve during systole
Implementation Method 3
at least one anchoring element, which anchoring element is coupled to the main body and is capable to anchor the main body within the native mitral valve region of a heart
Data Source
Figure 1
Figure 2A~2B
Figure 3
AI summary
The present invention relates to a prosthetic mitral valve device (100) for implanting at the native mitral valve region of a heart. The prosthetic mitral valve coaptation enhancement device comprises a main body (101) consisting of a stentframe (106) and a valve element (111) attached thereto, wherein the main body has a sealing section (108) and a valve-bearing section (110), the valve- bearing section carrying the valve element (111); the shape of the sealing section of the main body, in the compressed state, has a form that is adapted to the coaptation zone of the native mitral valve during systole, and the radial rigidity of the sealing section of the stent frame is lower than the radial rigidity of the valve-bearing section; the prosthetic mitral valve coaptation enhancement device further comprises at least one anchoring element, which anchoring element is coupled to the main body and is capable to anchor the main body within the native mitral valve region of a heart.