Segmented Prosthetic Heart Valve Anchoring for Mitral Geometry

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Solution Overview

Problem

Current prosthetic heart valve devices are inadequate for percutaneous replacement of native mitral valves due to the mitral valve's complex, non-circular, and non-planar geometry, which poses challenges in design, fit, and functionality, leading to issues like backflow and improper leaflet closure.

Innovation Solution

The development of a prosthetic heart valve device with a unique anchoring member and extension member configuration that can adapt to the irregular shape of the mitral valve annulus, providing radial support and ensuring proper alignment and sealing of the prosthetic valve.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If conventional prosthetic valve designs are used, then manufacturing and implantation are simpler, but they cannot adapt to the complex non-circular non-planar geometry of the mitral valve annulus, leading to poor fit and backflow

Engineering Contradiction:
Improveadaptability to mitral valve geometryVSAvoiddevice structure complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The support member is divided into multiple discrete segments that can independently assume different configurations. Each segment can be positioned and oriented separately to conform to the complex non-circular non-planar geometry of the mitral valve annulus, enabling adaptation to irregular shapes while maintaining manageable device complexity through modular construction

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The support member segments are designed to be movable relative to one another, allowing the structure to dynamically adjust and conform to the irregular mitral valve annulus geometry. This dynamic capability enables the device to adapt to complex anatomical variations while the segments can be controlled during implantation to achieve the desired configuration

Inventive Principle:
Principle #15Dynamics

2Object-affected harmful factors

If percutaneous approach is used, then invasiveness is reduced, but proper alignment and sealing of the prosthetic valve becomes more difficult due to lack of direct visual access and manual manipulation

Engineering Contradiction:
ImproveinvasivenessVSAvoidalignment precision
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The support member segments are designed with self-aligning features that enable them to automatically position themselves correctly within the mitral valve annulus during percutaneous implantation. The segments can self-adjust to achieve proper alignment and sealing without requiring direct visual access or extensive manual manipulation, thus maintaining percutaneous benefits while achieving precise positioning

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The device incorporates mechanisms that provide feedback during implantation to guide proper positioning of the support member segments. This feedback system enables the operator to adjust segment positions to achieve optimal alignment and sealing, compensating for the lack of direct visual access inherent in percutaneous approaches

Inventive Principle:
Principle #23Feedback

3Reliability

If annular cinching is performed, then mitral valve regurgitation is treated, but the procedure requires highly skilled surgeons and may cause tissue damage due to suturing

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidprocedural complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The device replaces the mechanical suturing process with a percutaneously implantable support member that provides annular cinching through its structural configuration. Instead of requiring surgical sutures to cinch the annulus, the segmented support member can be positioned to provide the cinching effect mechanically, eliminating the need for complex suturing techniques and reducing procedural complexity while maintaining treatment effectiveness

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3763332B1Prosthetic heart valve devices
Publication Date: 2025.01.22 TWELVE INC
  • EP3763332B1 patent drawingFigure 1
  • EP3763332B1 patent drawingFigure 2~3
  • EP3763332B1 patent drawingFigure 4~5

AI summary

The present technology is a prosthetic heart valve device, and related systems and methods, for treating a native valve of a human heart having a native annulus and native leaflets. One embodiment comprises a valve support, a prosthetic valve assembly within the valve support, and an anchoring member having an upstream portion and a downstream portion. The device further includes an extension member coupled to the fixation frame and extending radially outward therefrom. The extension member includes a plurality of wires, at least a portion of which include an inner core surrounded by an outer material. The wires include a plurality of recesses extending through at least a portion of the thickness of the outer material, and a therapeutic agent in the recesses for delivery to the anatomy when the prosthetic heart valve device is positioned at a native annulus.