Atrial-Anchored Mitral Prosthesis for Catheter-Based Regurgitation Control

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing treatments for mitral valve regurgitation, such as surgical replacement and annuloplasty, are invasive and require significant heart remodeling, with limited ability to evaluate efficacy before completion, and there is a need for less invasive methods that can effectively reduce or eliminate regurgitation.

Innovation Solution

A prosthesis is implanted within the heart to block gaps between mitral valve leaflets using an anchoring ring and a pocket member that expands to fill gaps when the valve closes, reducing regurgitation by minimizing openings between the leaflets.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical replacement with artificial valve is performed, then mitral valve regurgitation is treated, but the procedure is highly invasive and increases risk of serious complications

Engineering Contradiction:

Improvetreatment efficacyVSAvoidinvasiveness and complication risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs a flexible membrane or thin film structure that can be delivered via catheter and deployed within the heart to treat mitral valve regurgitation. This flexible shell approach allows minimally invasive delivery while providing the necessary structural support to reduce regurgitation, avoiding the need for open-heart surgery and artificial mechanical valves.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent introduces an intermediary device - a flexible membrane or occlusion device - that mediates between the faulty mitral valve and the blood flow. This intermediary structure can be delivered through catheterization and deployed to reduce regurgitation without requiring direct replacement of the native valve, thereby reducing invasiveness while maintaining treatment efficacy.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If annuloplasty ring is sewn within the annulus, then leaflet coaptation is improved, but the natural curved shape of the mitral valve is distorted and contractility is limited

Engineering Contradiction:

Improveleaflet coaptationVSAvoidnatural valve shape and contractility

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent uses a flexible membrane or thin film structure that can adapt to the natural curvature of the mitral valve annulus without imposing a rigid geometric constraint. This flexible approach maintains the natural shape and contractility of the valve while still providing the necessary support to improve leaflet coaptation and reduce regurgitation.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The patent employs a dynamic, flexible structure that can move and adapt with the natural contractility of the mitral valve annulus during the cardiac cycle. Unlike rigid annuloplasty rings, this dynamic structure allows the valve to maintain its natural motion and shape changes while still providing therapeutic benefit for regurgitation.

Inventive Principle:

Principle #15Dynamics

3Device complexity

If bowtie repair or placation is performed, then less heart remodeling is required compared to valve replacement, but substantial remodeling is still required and efficacy evaluation is difficult

Engineering Contradiction:

Improveamount of heart remodelingVSAvoidprocedure efficacy evaluation

Core Design Contradiction:

Device complexityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent introduces an intermediary device that can be delivered via catheter and deployed within the heart to reduce regurgitation. This approach requires minimal heart remodeling compared to surgical techniques, and the device's presence and function can be evaluated through imaging and hemodynamic measurements during and after the procedure, providing objective efficacy assessment.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 prosthesis dynamically adjusts to fill gaps between mitral valve leaflets, reducing or eliminating regurgitation with minimal invasiveness and adaptability to various pathologies.

Implementation Method 1

When the mitral valve closes, the backpressure of the blood pushes into the pocket member, expanding the pocket member to an inflated shape

Methodology Applied

Scientific EffectPressure gradient: Pressure Gradient

Implementation Method 2

The prosthesis includes an anchoring ring that expands within the left atrium to anchor the prosthesis

Methodology Applied

Scientific EffectElastic expansion: Elasticity

Data Source

PatentUS12458497B2Method of implanting valve prosthesis having atrial anchoring

Publication Date: 2025.11.04 EDWARDS LIFESCIENCES AG

AI summary

A method of treating a native mitral valve without open-heart surgery is disclosed. An expandable prosthesis includes an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end portion of a delivery catheter and is advanced through a femoral vein and through a pre-made puncture in an atrial septum. The anchoring portion self-expands within the left atrium for anchoring the occluding member in a fixed position. The anchoring portion is preferably a laser cut structure that conforms to the left atrium and uniformly distributes anchoring forces within the left atrium. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole. The occluding member is preferably made from a flexible material, such as pericardial tissue.