Endovascular Cutting System for Mitral Valve Fixation Device Removal

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Solution Overview

Problem

Current methods for removing or disabling mitral valve fixation devices require open heart surgery, posing high risks and extended recovery times, and there is a need for alternative minimally invasive techniques to address mitral valve regurgitation and facilitate other heart procedures without open chest access.

Innovation Solution

The development of systems and methods using endovascular procedures involving catheters and cutting members to detach or remove fixation devices from valve leaflets, allowing for minimally invasive detachment of suture 'bow-tie' or edge-to-edge repair devices from the mitral valve, enabling procedures without open heart access.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If open heart surgery is used to remove fixation devices, then complete removal is achieved, but patient risk and recovery time increase significantly

Engineering Contradiction:
Improvefixation device removal completenessVSAvoidpatient risk and recovery time
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces the mechanical open-heart surgical approach with an endovascular catheter-based system. The cutting member delivered through the catheter uses controlled cutting action to detach the fixation device from valve leaflets, eliminating the need for chest opening and cardiopulmonary bypass while achieving complete device removal

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

Solution Approach 2:

The patent introduces a catheter as an intermediary tool to access the heart's interior without open surgery. The catheter delivers the cutting member to the fixation device location, enabling remote manipulation and detachment of the fixation device from valve leaflets through minimally invasive vascular access

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If minimally invasive endovascular procedures are used, then patient risk and recovery time are reduced, but the ability to perform complex tissue detachment is limited

Engineering Contradiction:
Improvepatient risk and recovery timeVSAvoidtissue detachment capability
Core Design Contradiction:
Object-affected harmful factorsVSAdaptability or versatility

Solution Approach 1:

The catheter system is designed with multi-functionality to perform various tasks through a single minimally invasive access point. The system can navigate to different locations, deliver cutting members, and manipulate fixation devices attached to valve leaflets, providing versatile tissue detachment capability without requiring open surgery

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The cutting member is designed with dynamic characteristics, including the ability to advance, retract, and rotate within the catheter. This dynamic design allows the cutting member to adapt to different fixation device configurations and leaflet positions, enabling effective detachment through minimally invasive access

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 safe and minimally invasive detachment of fixation devices from valve leaflets, reducing risks and recovery times, and allowing for further heart procedures without the need for open heart surgery, thereby improving patient outcomes.

Implementation Method 1

cutting of leaflet tissue in preparation of subsequent implanting of a medical implant through minimally invasive procedures

Methodology Applied
Scientific EffectMechanical cutting: Fracture Mechanics

Data Source

PatentUS12102531B2Tissue cutting systems, devices and methods
Publication Date: 2024.10.01 EVALVE
  • US12102531B2 patent drawing
  • US12102531B2 patent drawing
  • US12102531B2 patent drawing

AI summary

Methods, devices and systems for disabling and/or removing a mitral valve edge-to-edge repair device via minimally invasive, endovascular procedures. Additional procedures on a heart may sometimes become necessary after the installation of a mitral valve edge-to-edge repair device. To prepare for such additional procedures, the edge-to-edge repair device may be removed or disabled in minimally invasive ways (e.g., through an endovascular procedure), without requiring open access to the heart.