Flexible Canopy Valve Repair Tensioning

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Solution Overview

Problem

Current treatments for mitral valve regurgitation due to a prolapsing leaflet are invasive, have significant drawbacks in terms of efficacy and safety, and may compromise future treatments by reducing the cross-sectional area for blood flow or altering the valve anatomy.

Innovation Solution

A system comprising a flexible canopy and an elongated tether, where the tether is placed under tension to prevent leaflet prolapse, allowing the canopy to coapt with opposing leaflets, thereby minimizing regurgitation without reducing blood flow or altering the valve's cross-sectional area, and is adjustable to accommodate anatomical changes.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If re-sectioning of the prolapsed tissue or chordae repair is performed, then the valve regurgitation is treated, but the valve anatomy is altered and future treatments may be compromised

Engineering Contradiction:
Improvevalve regurgitation treatment efficacyVSAvoidavailability for future treatments
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The system employs a adjustable tension mechanism that allows dynamic modification of the canopy's positioning and tensioning. The tensioning element can be adjusted to accommodate anatomical changes over time, enabling the same device to maintain effectiveness while preserving the valve's natural anatomy for potential future treatments.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the parameter of tissue tension by applying controlled tension to the tensioning element, which adjusts the canopy's position and its relationship with the prolapsed leaflet. This parameter adjustment allows the system to treat regurgitation without permanently altering the valve's structural parameters, preserving anatomy for future treatments.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If placement of a new valve or attachment of a clip is performed, then the valve regurgitation is treated, but the cross-sectional area for blood flow is reduced

Engineering Contradiction:
Improvevalve regurgitation treatment efficacyVSAvoidcross-sectional area for blood flow
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

The system introduces an intermediary element (the canopy supported by the tensioning element) that mediates between the prolapsed leaflet and the remaining healthy tissue. This intermediary structure provides support and coaptation without requiring removal or replacement of the native valve leaflets, thereby preserving the cross-sectional area for blood flow while effectively treating regurgitation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the valve is repaired by traditional methods, then regurgitation is reduced, but the valve becomes less efficient and elasticity is lost

Engineering Contradiction:
Improveregurgitation reductionVSAvoidvalve elasticity and efficiency
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The system allows the valve's own elastic properties to be utilized by applying tension through the tensioning element to the canopy, which then works with the natural elasticity of the valve tissue to achieve coaptation. This self-service approach treats regurgitation while preserving and utilizing the valve's inherent elastic properties rather than compromising them.

Inventive Principle:
Principle #25Self-service

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 reduces or eliminates valvular regurgitation while maintaining the valve's functionality and accessibility for future treatments, ensuring efficient blood flow and minimizing complications.

Implementation Method 1

The elongated tether includes an inelastic portion and an elastic portion that is at least as long as the inelastic portion

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentEP3768195B1Flexible canopy valve repair systems
Publication Date: 2024.04.24 MEDTRONIC VASCULAR INC
  • EP3768195B1 patent drawingFigure 1
  • EP3768195B1 patent drawingFigure 2A~2B
  • EP3768195B1 patent drawingFigure 2C~2D

AI summary

A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.