Flared Stent Anchoring for Mitral Valve Replacement

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Solution Overview

Problem

Conventional collapsible prosthetic heart valves face challenges in anchoring within the native valve annulus due to varying radial forces, which can cause tissue damage or valve displacement, especially in locations lacking calcification, and may not effectively restore native valve leaflet function.

Innovation Solution

A prosthetic heart valve design featuring a stent with a flared portion and engaging arms, along with a braided frame and skirt configuration, that expands to provide radial force for anchoring and minimize paravalvular leakage, while allowing for secure attachment to the native valve annulus and restoration of native valve leaflet function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If conventional collapsible prosthetic heart valves are deployed in the native valve annulus, then the valve can be delivered less invasively via catheter, but the anchoring stability is compromised due to varying radial forces and lack of calcification in certain locations

Engineering Contradiction:
Improvedelivery methodVSAvoidanchoring stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The stent is divided into multiple functional segments: a flared portion for radial anchoring, engaging arms with tips for mechanical interlocking, and a body portion for valve support. This segmentation allows each segment to address specific anchoring challenges in different locations within the native valve annulus.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the stent are designed with locally optimized properties: the flared portion provides radial outward force for anchoring, the engaging arms provide mechanical interlocking, and the body portion supports the valve structure. This local differentiation enables effective anchoring in locations with varying calcification patterns.

Inventive Principle:
Principle #3Local quality

2Reliability

If the stent is designed with engaging arms and flared portion to enhance anchoring, then the anchoring stability improves, but the device complexity increases

Engineering Contradiction:
Improveanchoring stabilityVSAvoidstent structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

Multiple anchoring functions are merged into a single integrated stent structure. The flared portion, engaging arms, and body portion work together as a unified mechanism to provide both radial anchoring and mechanical interlocking, eliminating the need for separate anchoring devices.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The stent structure serves multiple functions simultaneously: it anchors the valve in place, provides radial support, enables mechanical interlocking with tissue, and supports the valve leaflets. This multi-functionality reduces the need for additional separate components.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If radial force is increased to improve anchoring in locations lacking calcification, then anchoring stability improves, but tissue damage risk increases

Engineering Contradiction:
Improveanchoring stabilityVSAvoidtissue damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The engaging arms are designed to engage with the native valve annulus structure before full radial expansion occurs. This preliminary mechanical interlocking prevents the need for excessive radial force during deployment, thereby reducing tissue damage risk while ensuring stable anchoring.

Inventive Principle:
Principle #10Preliminary action

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 design enhances the anchoring and stability of the prosthetic valve within the native valve annulus, reducing the risk of tissue damage and valve displacement, and effectively restores native valve function by providing a secure and stable interface with the surrounding tissue.

Implementation Method 1

the stent with a flared portion and engaging arms, along with a braided frame and skirt configuration, that expands to provide radial force for anchoring

Methodology Applied
Scientific EffectRadial force: Force

Implementation Method 2

braided frame and skirt configuration, that expands to provide radial force for anchoring and minimize paravalvular leakage

Methodology Applied
Scientific EffectStructural support: Mechanical Force

Data Source

PatentEP3273910B1Mitral heart valve replacement
Publication Date: 2024.12.18 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP3273910B1 patent drawingFigure 1
  • EP3273910B1 patent drawingFigure 2A~2B
  • EP3273910B1 patent drawingFigure 3

AI summary

A prosthetic heart valve having an inflow end and an outflow end includes a collapsible and expandable stent including a plurality of cells arranged in rows extending around a circumference of the stent, at least one of the rows forming a flared portion having a diameter that is larger than diameters of others of the rows. The stent further includes engaging arms disposed adjacent the outflow end and extending toward the inflow end, the engaging arms being configured to couple to heart tissue to anchor the stent. A collapsible and expandable valve assembly has a plurality of leaflets disposed within the stent.