Mitral Prosthetic Valve Anchoring for Minimally Invasive Replacement

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Solution Overview

Problem

There is a need for minimally invasive techniques to replace the mitral valve, as existing catheter-based procedures are not applicable due to the distinct differences between the aortic and mitral valves, particularly the complex subvalvular apparatus of the mitral valve, limiting treatment options for high-risk patients.

Innovation Solution

A prosthetic apparatus for the mitral valve region that is radially compressible and self-expandable, utilizing ventricular anchors to secure the prosthetic valve within the native mitral valve annulus, and an atrial sealing member to prevent paravalvular leakage, with delivery systems enabling minimally invasive implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is performed for mitral valve replacement, then complete valve replacement can be achieved, but the procedure is highly invasive and prone to complications

Engineering Contradiction:
Improvevalve replacement effectivenessVSAvoidinvasiveness and complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The mitral valve replacement system is divided into separate components: a catheter-based delivery system, an expandable valve frame, and native leaflet integration mechanisms. This allows the valve to be delivered through a minimally invasive transvascular approach rather than requiring open heart surgery, while still achieving complete valve replacement functionality

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent uses the native mitral valve leaflets as an intermediary structure to facilitate attachment and integration of the prosthetic valve. The leaflets serve as a natural bridge between the native valve anatomy and the artificial valve, enabling secure attachment without requiring extensive surgical intervention

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If catheter-based procedures are used for mitral valve replacement, then invasiveness is reduced, but the procedure is not applicable due to complex subvalvular apparatus

Engineering Contradiction:
ImproveinvasivenessVSAvoidapplicability to mitral valve anatomy
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The patent applies different functional characteristics to different parts of the valve system: the frame provides structural support and expandability, the leaflets provide natural attachment points, and the anchoring mechanisms provide secure fixation. This localized functional differentiation allows the system to adapt to the complex mitral valve anatomy while maintaining minimally invasive delivery

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The native mitral valve leaflets are utilized in advance as attachment structures before the prosthetic valve is fully deployed. This preliminary use of native anatomy simplifies the implantation process and increases adaptability to the specific mitral valve geometry

Inventive Principle:
Principle #10Preliminary action

3Reliability

If traditional valve anchoring methods are used, then secure fixation can be achieved, but paravalvular leakage occurs

Engineering Contradiction:
Improvevalve fixation securityVSAvoidparavalvular leakage
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The patent combines multiple anchoring mechanisms into a unified system: radial expansion of the frame against the annulus, attachment to native leaflets, and potential tissue ingrowth promotion. This multi-modal anchoring approach simultaneously achieves secure fixation and seals the interface between the prosthetic and native valve, preventing paravalvular leakage

Inventive Principle:
Principle #5Merging (Combining)

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 prosthetic apparatus effectively secures the valve in the mitral valve annulus, remodels the left ventricle, and reduces paravalvular leakage, providing a viable minimally invasive treatment option for mitral valve replacement.

Implementation Method 1

a main body that is radially compressible to a radially compressed state and self-expandable from the compressed state to a radially expanded state

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

self-expandable from the compressed state to a radially expanded state

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 3

the space decreases to capture the leaflet between the main body and the ventricular anchor

Methodology Applied
Scientific EffectMechanical compression: Compression

Data Source

PatentEP4306158B1Prosthetic valve for replacing mitral valve
Publication Date: 2025.08.20 EDWARDS LIFESCIENCES CORP
  • EP4306158B1 patent drawingFigure 1
  • EP4306158B1 patent drawingFigure 2~4A
  • EP4306158B1 patent drawingFigure 4B~4D

AI summary

Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A preferred embodiment of a prosthetic valve includes a radially compressible main body and a one-way valve portion. The prosthetic valve further comprises at least one ventricular anchor coupled to the main body and disposed outside of the main body. A space is provided between an outer surface of the main body and the ventricular anchor for receiving a native mitral valve leaflet. The prosthetic valve preferably includes an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for delivering and implanting the prosthetic valve are also described.