Mitral Valve SAM Containment Member for LVOT Obstruction

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Solution Overview

Problem

Prosthetic heart valves, particularly those for the mitral position, often cause systolic anterior motion (SAM) of the native mitral valve leaflet, leading to potential LVOT obstruction and increased pressure gradients, which can worsen existing conditions or create new pathologic issues, such as heart failure.

Innovation Solution

A prosthetic mitral valve system with an expandable valve frame and anchor assembly, featuring a SAM containment member that is configured to be disposed behind the anterior leaflet, preventing it from entering the LVOT and reducing the risk of obstruction by using a delivery system with a control wire to deploy and reconfigure the containment member.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a prosthetic valve is implanted in a native mitral valve without removal or restraint of the native valve leaflets, then the prosthetic valve can be implanted using less invasive techniques, but the anterior leaflet may be pulled into the LVOT by Bernoulli forces causing LVOT obstruction

Engineering Contradiction:

Improveease of implantationVSAvoidLVOT obstruction

Core Design Contradiction:

Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

A SAM containment member is introduced as an intermediary component between the prosthetic valve and the native anterior leaflet. This member physically prevents the leaflet from being pulled into the LVOT by Bernoulli forces while allowing the prosthetic valve to function normally. The containment member acts as a mediator that resolves the conflict between maintaining native leaflet function and preventing LVOT obstruction.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The SAM containment member is deployed in advance to counteract the harmful Bernoulli forces before they can cause significant LVOT obstruction. By establishing this protective structure beforehand, the system prevents the anterior leaflet from being drawn into the outflow tract during systole.

Inventive Principle:

Principle #9Preliminary anti-action

2Adaptability or versatility

If the anterior leaflet is drawn into the LVOT, then the prosthetic valve can maintain native leaflet function, but it creates significant clinical concern due to outflow interference

Engineering Contradiction:

Improvenative leaflet functionVSAvoidoutflow reliability

Core Design Contradiction:

Adaptability or versatilityVSReliability

Solution Approach 1:

The system segments the functional responsibilities by separating the SAM containment function from the valve occlusion function. The containment member specifically addresses leaflet positioning while the prosthetic valve handles blood flow control, allowing both native leaflet function and reliable outflow to be maintained simultaneously.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The SAM containment member serves as an intermediary structure that allows the native anterior leaflet to maintain its natural function while preventing it from interfering with LVOT outflow. This mediator enables both adaptability (native function) and reliability (outflow) to coexist.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If some prosthetic valve systems physically obstruct the LVOT, then they can prevent SAM, but they may create high LVOT pressure gradients and worsen existing pathologic conditions

Engineering Contradiction:

ImproveSAM preventionVSAvoidpressure gradients

Core Design Contradiction:

ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The SAM containment member provides localized intervention only where needed - specifically containing the anterior leaflet in the region where it would cause SAM - while leaving the rest of the LVOT patent and unobstructed. This localized approach prevents SAM without creating significant pressure gradients across the entire outflow tract.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

Instead of using a broad obstruction to prevent SAM, the containment member converts the potential harm of leaflet motion into a controlled, localized containment strategy that maintains overall LVOT patency and minimizes pressure gradient formation.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

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 system effectively minimizes the risk of LVOT obstruction and ensures reliable, repeatable, and less invasive mitral valve replacement procedures, maintaining native leaflet function and reducing adverse health events like heart failure.

Implementation Method 1

the anterior leaflet may be exposed to different flow conditions which may actually 'pull' the anterior leaflet, via Bernoulli forces, toward and into the LVOT

Methodology Applied

Scientific EffectBernoulli forces: Bernoulli Effect

Data Source

PatentEP3270827B1Systems for heart valve therapy

Publication Date: 2023.12.20 CAISSON INTERVENTIONAL LLC

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AI summary

Prosthetic mitral valves described herein can be deployed using a transcatheter mitral valve delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native mitral valve. This document describes prosthetic heart valve designs and techniques to manage blood flow through the left ventricular outflow tract. For example, this document describes prosthetic heart valve designs and techniques that reduce or prevent obstructions of the left ventricular outflow tract that may otherwise result from systolic anterior motion of an anterior leaflet of the native mitral valve.