Cardiac Valve Coaptation Element for Regurgitation Reduction

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Solution Overview

Problem

Current methods for treating heart valve regurgitation, such as open-heart surgery, are invasive and not suitable for high-risk patients, necessitating a minimally invasive alternative that can reduce or eliminate regurgitation through heart valves like the tricuspid and mitral without replacing the native valve.

Innovation Solution

A device comprising an anchor deployable in the right ventricle, a flexible anchor rail, a coaptation element with a mechanical frame or compressible biocompatible material, and a locking mechanism, which is delivered via a catheter to reduce regurgitation by creating a seal between the native leaflets, allowing for minimally invasive implantation and adjustment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery is used to treat heart valve regurgitation, then valve function can be improved, but the procedure is highly invasive and not suitable for high-risk patients

Engineering Contradiction:
Improvevalve functionVSAvoidinvasiveness
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgery approach with a catheter-based minimally invasive system. The device uses a catheter delivered through the subclavian vein to deploy a coaptation element that creates a seal between leaflets, eliminating the need for surgical exposure and direct mechanical manipulation of the valve.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a coaptation element as an intermediary component that mediates between the native valve leaflets and the catheter delivery system. This coaptation element rides over the anchor rail and creates the sealing interface, allowing the minimally invasive catheter to achieve valve repair without directly replacing the valve.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If a minimally invasive device is developed to reduce regurgitation, then patient risk is reduced, but the device complexity increases

Engineering Contradiction:
Improvepatient riskVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent divides the device into distinct functional segments: an anchor portion for securing to the ventricle, an anchor rail for guidance, a coaptation element for sealing, and a delivery catheter for transport. This segmentation allows each component to be optimized independently while maintaining overall simplicity in the minimally invasive delivery approach.

Inventive Principle:
Principle #1Segmentation

3Ease of operation

If the coaptation element is made compressible for delivery, then ease of delivery is improved, but the structural stability during operation may be compromised

Engineering Contradiction:
Improveease of deliveryVSAvoidstructural stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent employs a dynamic coaptation element that transitions from a compressed state during delivery to an expanded state during operation. The coaptation element is compressed within the catheter for delivery through the subclavian vein, then expands at the deployment site to create the necessary sealing surface area between the leaflets, achieving both ease of delivery and operational stability.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentEP2849681B1Devices for reducing cardiac valve regurgitation
Publication Date: 2017.08.02 EDWARDS LIFESCIENCES CORP
  • EP2849681B1 patent drawingFigure 1A
  • EP2849681B1 patent drawingFigure 1B
  • EP2849681B1 patent drawingFigure 2A~2C

AI summary

The present invention relates to devices and methods for improving the function of a defective heart valve, and particularly for reducing regurgitation through an atrioventricular heart valve - i.e., the mitral valve and the tricuspid valve. For a tricuspid repair, the device includes an anchor deployed in the tissue of the right ventricle, in an orifice opening to the right atrium, or anchored to the tricuspid valve. A flexible anchor rail connects to the anchor and a coaptation element on a catheter rides over the anchor rail. The catheter attaches to the proximal end of the coaptation element, and a locking mechanism fixes the position of the coaptation element relative to the anchor rail. Finally, there is a proximal anchoring feature to fix the proximal end of the coaptation catheter subcutaneously adjacent the subclavian vein. The coaptation element includes an inert covering and helps reduce regurgitation through contact with the valve leaflets.