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

VSEngineering 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

Engineering Contradiction:
Improveminimally invasive treatmentVSAvoidtreatment efficacy
Core Design Contradiction:
Ease of operationVSReliability

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

Inventive Principle:
Principle #1Segmentation

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

Inventive Principle:
Principle #3Local quality

2Reliability

If the device is designed to fit the asymmetric mitral annulus shape, then better sealing is achieved, but device complexity increases

Engineering Contradiction:
Improvesealing effectivenessVSAvoiddevice structure
Core Design Contradiction:
ReliabilityVSDevice complexity

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

Inventive Principle:
Principle #15Dynamics

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

Inventive Principle:
Principle #35Parameter changes

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

Engineering Contradiction:
Improvevalve functionVSAvoidadaptation to coaptation zone
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

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

Inventive Principle:
Principle #1Segmentation

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

Inventive Principle:
Principle #3Local quality

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

Methodology Applied
Scientific EffectSelf-expansion: Elastic Recovery

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

Methodology Applied
Scientific EffectRadial compression and adaptation: Deformation

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

Methodology Applied
Scientific EffectAnchoring: Mechanical Fastener

Data Source

PatentEP3184081B1Prosthetic mitral valve coaptation enhancement device
Publication Date: 2021.03.24 MEDIRA AG
  • EP3184081B1 patent drawingFigure 1
  • EP3184081B1 patent drawingFigure 2A~2B
  • EP3184081B1 patent drawingFigure 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.