Catheter-Based Mitral Valve Fixation Actuator Mechanism

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Solution Overview

Problem

Current methods for treating mitral valve regurgitation often require open chest surgery and cardiopulmonary bypass, which are invasive and carry high mortality and morbidity risks, and minimally invasive procedures face challenges in visualizing and accurately delivering fixation devices to the mitral valve leaflets.

Innovation Solution

A fixation system comprising an implantable device with movable arms and a coupling mechanism, delivered via a catheter, that allows for grasping, approximating, and optionally repositioning or removing valve leaflets to address regurgitation, using a delivery device with actuators to facilitate precise placement and attachment without open chest access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open chest surgery and cardiopulmonary bypass are used to treat mitral valve regurgitation, then effective valve repair can be achieved, but patient trauma and procedural risk increase significantly

Engineering Contradiction:

Improvevalve repair effectivenessVSAvoidpatient trauma and procedural risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-chest surgical system with a catheter-based delivery system that can be inserted through peripheral vessels. The fixation device is delivered via catheter to the mitral valve, eliminating the need for sternotomy and cardiopulmonary bypass while maintaining effective valve repair capability

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent introduces a catheter as an intermediary delivery mechanism between the operator and the mitral valve. The catheter system includes a delivery catheter, actuation mechanisms, and fixation device components that work together to deliver and deploy the fixation device minimally invasively, serving as a mediator that avoids direct open-chest access

Inventive Principle:

Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive catheter-based procedures are used to deliver fixation devices, then patient trauma is reduced, but visualization and delivery precision become more challenging

Engineering Contradiction:

Improvepatient traumaVSAvoiddelivery precision and visualization

Core Design Contradiction:

Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The patent incorporates radiopaque markers and imaging-visualizable components on the fixation device and catheter system. These components allow the operator to track the position and deployment of the fixation device using fluoroscopy and other imaging modalities, ensuring precise delivery despite the minimally invasive approach

Inventive Principle:

Principle #32Color changes

Solution Approach 2:

The patent incorporates imaging and visualization feedback mechanisms that allow the operator to monitor the catheter and fixation device position in real-time during the procedure. This feedback enables precise adjustment and placement of the fixation device on the mitral valve leaflets while maintaining minimal invasiveness

Inventive Principle:

Principle #23Feedback

3Ease of manufacture

If fixation devices are made permanently fixed upon delivery, then deployment simplicity is improved, but ability to reposition or remove for optimal placement is lost

Engineering Contradiction:

Improvedeployment simplicityVSAvoidrepositioning and removal capability

Core Design Contradiction:

Ease of manufactureVSAdaptability or versatility

Solution Approach 1:

The patent designs the fixation device with dynamic, reversible attachment characteristics. The fixation device can be initially delivered in a deployed state and then selectively released or repositioned if optimal placement is not achieved. This dynamic capability allows the system to adapt during the procedure while maintaining relatively simple deployment mechanics

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The patent incorporates a preliminary testing phase where the fixation device is delivered and positioned before permanent fixation. The device can be held in a temporary state that allows for position verification and adjustment, and only after optimal placement is confirmed does permanent fixation occur, ensuring both simplicity and adaptability

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS20240074854A1Proximal Element Actuator Fixation And Release Mechanisms

Publication Date: 2024.03.07 EVALVE

AI summary

Fixation system for engaging tissue of a patient including an implantable fixation device having a first arm and a second arm, a first proximal element, a second proximal element, and a coupling member. The system includes a delivery device having a catheter, a shaft extending through the at least one lumen of the catheter, a first proximal element actuator and a second proximal element actuator. The second end portions of the first proximal element actuator and second proximal element actuator can be coupled to at least one of the shaft and the coupling member.