Mitral Valve Annulus Resizing via Helical Anchor Penetration

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Solution Overview

Problem

Current methods for treating mitral valve regurgitation, such as open-heart surgery, are invasive and carry significant risks, and there is a need for a less invasive solution to effectively reduce the size of the mitral valve annulus to prevent leakage.

Innovation Solution

A tubular implant with a frame and helical anchors that can transition from a smaller to a larger diameter configuration, allowing the anchors to penetrate and engage the mitral valve annulus, reducing the valve's size through an expansive force applied to the upper portion, thereby reducing leakage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open-heart surgery is performed to repair the mitral valve, then the mitral valve can be effectively repaired, but the procedure is highly invasive and carries significant risks

Engineering Contradiction:
Improvemitral valve repair effectivenessVSAvoidinvasiveness and surgical risks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that uses a catheter-based approach. The implant is delivered through a catheter inserted via a peripheral vessel, eliminating the need for sternotomy and cardiopulmonary bypass. This substitution of the delivery mechanism reduces invasiveness while maintaining repair effectiveness.

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

Solution Approach 2:

The patent introduces a transcatheter delivery system as an intermediary between the operator and the target mitral valve. The delivery catheter serves as a mediator that transports the implant to the precise location without requiring direct surgical access to the heart, thereby reducing surgical trauma and risks.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If a tubular implant with helical anchors is used to reduce mitral valve annulus size, then the valve annulus can be effectively resized, but the device structure becomes complex

Engineering Contradiction:
Improvevalve annulus resizing precisionVSAvoidimplant structure complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The implant is segmented into multiple functional components: a tubular body for structural support, helical anchors for tissue engagement, and an expandable mechanism for size adjustment. This segmentation allows each component to perform its specific function optimally while enabling precise control over the valve annulus resizing.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The implant incorporates a dynamic expandable mechanism that allows the tubular body to transition between compressed and expanded states. This dynamic capability enables the device to be delivered in a compact form through the catheter and then expanded at the target site to achieve the precise sizing needed for effective mitral valve repair.

Inventive Principle:
Principle #15Dynamics

3Object-affected harmful factors

If the implant is delivered through a catheter, then the procedure becomes minimally invasive, but the delivery system complexity increases

Engineering Contradiction:
Improveprocedure invasivenessVSAvoiddelivery system complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The implant is designed to be nested within the delivery catheter in a compressed state. The tubular body and helical anchors are contained within the catheter lumen during delivery, allowing the entire system to be introduced through a peripheral vessel. After deployment, the implant is expanded and the delivery catheter is withdrawn, eliminating the need for complex external manipulation mechanisms.

Inventive Principle:
Principle #7Nested doll (Nesting)

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

This approach allows for a minimally invasive procedure to resize the mitral valve annulus, reducing the risk of complications and effectively addressing mitral regurgitation by enabling proper closure of the valve leaflets.

Implementation Method 1

a plurality of helical anchors connected to the tubular body proximate the distal diameter of the frame, the plurality of helical anchors configured to be rotated by a plurality of rotatable drivers to advance the plurality of helical anchors distally relative to the frame and penetrate the heart valve annulus

Methodology Applied
Scientific EffectHelical rotation: Helix

Implementation Method 2

transitioning the tubular body from a first structural configuration to a second structural configuration by application of an expansive force to the tubular body proximate the upper diameter

Methodology Applied
Scientific EffectExpansive force: Pressure Increase

Data Source

PatentEP3410984B1Mitral valve inversion prostheses
Publication Date: 2023.03.29 BOSTON SCIENTIFIC SCIMED INC
  • EP3410984B1 patent drawingFigure 1A
  • EP3410984B1 patent drawingFigure 1B
  • EP3410984B1 patent drawingFigure 1C

AI summary

Systems, devices and methods for resizing a valve annulus are described. An implant (910) is delivered proximate a mitral valve, the implant comprising a tubular body (940) and a plurality of piercing helical anchors (930), the tubular body comprising an proximal diameter and a distal diameter. Tissue proximate the mitral valve is engaged by rotating the plurality of anchors with corresponding rotational drivers. The tubular body may be transitioned from a first structural configuration having the proximal diameter smaller than the distal diameter to a second structural configuration having the proximal diameter larger than the distal diameter.