Flexible Actuator Mandrel for Mitral Valve Repair

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Solution Overview

Problem

Current methods for repairing mitral valve regurgitation often require open heart surgery, which is invasive and carries high mortality and morbidity risks, and minimally invasive procedures face challenges in delivering and positioning fixation devices effectively.

Innovation Solution

A system comprising a multi-catheter guiding system, a delivery catheter, and an interventional device with a flexible cable and actuator rod, allowing for endovascular or minimally invasive access to the mitral valve, enabling 'edge-to-edge' or 'bow-tie' coaptation of valve leaflets without open chest surgery, with features for repositioning and removal of the fixation device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is used for mitral valve repair, then effective tissue approximation and fixation can be achieved, but patient trauma and mortality risk significantly increase

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidpatient trauma and mortality risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical system with a catheter-based delivery system that can be introduced percutaneously through the femoral vein. The fixation device is delivered via catheter to the mitral valve, eliminating the need for sternotomy and cardiopulmonary bypass while achieving the same tissue approximation and fixation效果

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a catheter as an intermediary delivery vehicle to transport the fixation device to the target site. The catheter serves as a mediator between the operator and the deep cardiac structures, enabling minimally invasive access to the mitral valve without direct surgical exposure

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive catheter-based procedures are used, then patient trauma is reduced, but delivery and positioning of fixation devices becomes challenging

Engineering Contradiction:

Improvepatient traumaVSAvoidfixation device delivery and positioning

Core Design Contradiction:

Object-affected harmful factorsVSEase of operation

Solution Approach 1:

The actuator rod is designed with flexible segments that allow it to bend and conform to the curvature of the catheter and cardiac anatomy. This dynamic flexibility enables the rigid fixation device to be navigated through the tortuous vascular path and positioned accurately at the mitral valve despite the minimally invasive approach

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The actuator rod is divided into multiple flexible segments that can independently bend and articulate. This segmentation allows the rod to navigate complex anatomical pathways while maintaining the ability to transmit mechanical forces for precise positioning and deployment of the fixation device

Inventive Principle:

Principle #1Segmentation

3Reliability

If fixation devices are made permanent, then reliable tissue approximation is maintained, but ability to reposition or remove device for optimal placement is lost

Engineering Contradiction:

Improvetissue approximation stabilityVSAvoiddevice repositioning and removal capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The fixation device incorporates reversible attachment mechanisms that allow it to be securely fixed to tissue when needed but also released and repositioned if optimal placement is not achieved. This dynamic attachment capability enables the device to transition between secured and movable states, providing both stability and adaptability

Inventive Principle:

Principle #15Dynamics

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

Enables minimally invasive repair of mitral valve regurgitation, reducing trauma and improving accessibility, allowing for effective coaptation of valve leaflets and potential for reversible procedures without significant clinical impairment.

Implementation Method 1

The flexible cable is resiliently biased to return to a substantially linear configuration after being deflected 90° or more

Methodology Applied

Scientific EffectElastic recovery: Elastic Recovery

Data Source

PatentEP3520715B1Flexible actuator mandrel for tissue apposition systems

Publication Date: 2022.09.14 EVALVE

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Figure 2A~2B
Figure 3A~3C

AI summary

The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.