Flared-Stent Mitral Valve Assembly for Migration-Resistant Anchoring

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Solution Overview

Problem

There are limited less-invasive options for mitral valve replacement, with existing technologies facing challenges such as stability issues and anatomical limitations, leading to a significant number of patients being denied surgical procedures due to risk factors.

Innovation Solution

A prosthetic mitral valve assembly with a flared upper end and tapered portion is designed to fit the contours of the native mitral valve, using a stent or outer support frame that expands radially to create a pressure fit, and may include anchoring members or tension members to secure the valve in place, allowing for transvascular or transapical implantation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a claw structure is used for attaching the prosthetic valve to the heart, then the valve can be anchored in place, but stability issues arise and consistent placement is limited

Engineering Contradiction:

Improvevalve anchoring stabilityVSAvoidplacement consistency

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The stent is divided into multiple segments or cells that can independently expand and conform to the mitral valve annulus. This segmentation allows the stent to achieve stable anchoring through distributed contact points rather than relying on a single claw structure, thereby improving both stability and placement consistency.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The stent features varying local geometries with different expansion characteristics, radial forces, and contact surface areas at different segments. This local quality variation enables optimal adaptation to the specific anatomical contours of the mitral valve annulus, achieving reliable anchoring without claw structures.

Inventive Principle:

Principle #3Local quality

2Reliability

If open heart surgery is performed for mitral valve replacement, then definitive treatment is achieved, but the procedure is prone to many complications and is not suitable for high-risk patients

Engineering Contradiction:

Improvetreatment effectivenessVSAvoidsurgical complications

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The invention replaces the mechanical open-heart surgical system with a percutaneous catheter-based delivery system. The stent is delivered through a catheter in a compressed state and then expanded at the target site using balloon expansion or self-expansion mechanisms, eliminating the need for sternotomy, cardiopulmonary bypass, and direct surgical manipulation of the heart.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The stent is designed with flexible materials that allow it to be compressed into a small profile for catheter delivery and then expanded to its functional configuration at the implantation site. This flexibility enables minimally invasive delivery while maintaining structural integrity and radial force upon deployment.

Inventive Principle:

Principle #30Flexible shells and thin films

3Stability of the object's composition

If a stent is designed to expand radially outwardly to create a pressure fit, then secure anchoring is achieved, but the device complexity increases

Engineering Contradiction:

Improvepressure fit anchoringVSAvoidstent structure complexity

Core Design Contradiction:

Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The stent structure performs multiple functions simultaneously: it provides radial expansion for pressure fit anchoring, conforms to the mitral valve annulus geometry, supports the prosthetic valve leaflets, and prevents paravalvular leakage. This multi-functionality is achieved through a unified stent design rather than separate components, reducing overall device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The prosthetic valve leaflets are nested within the stent structure, and the entire assembly is delivered within a catheter system. This nested configuration allows compact delivery while maintaining the functional integrity of each component upon deployment.

Inventive Principle:

Principle #7Nested doll (Nesting)

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 assembly provides a secure, less-invasive mitral valve replacement with minimal paravalvular leakage and regurgitation, maintaining proper valve function and reducing the risk of dislodgement or migration.

Implementation Method 1

The assembly is adapted to expand radially outwardly and into contact with the native tissue to create a pressure fit

Methodology Applied

Scientific EffectRadial expansion:

Data Source

PatentEP4104801B1Device for replacing mitral valve

Publication Date: 2025.10.01 EDWARDS LIFESCIENCES CORP

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AI summary

The invention relates to a prosthetic mitral valve assembly (100), comprising: a self expandable stent (102) made of a shape memory material, the stent including an upper portion having an enlarged or flared end that tapers to a lower portion having a reduced diameter, thereby conforming to a shape of the native mitral valve; and a tricuspid valve assembly connected to the stent, the valve assembly comprising bovine pericardial tissue; characterized by: a plurality of anchoring members (104) adapted for penetrating surrounding tissue and preventing upward migration of the mitral valve assembly.