Rotatable Grasping Arms for Cardiac Leaflet Cutting

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Solution Overview

Problem

Current methods for removing cardiac valve fixation devices are inefficient, often causing damage to surrounding tissues and structures, and can obstruct further interventional procedures, particularly due to difficulties in visualizing and cutting specific leaflet tissues without harming the posterior leaflet or entangling with sub-valvular structures.

Innovation Solution

A cutting mechanism with a steerable guide catheter and rotatable grasping arms that allow precise targeting and cutting of leaflet tissue, minimizing the risk of damage to surrounding structures and enabling effective removal of fixation devices or preparation for valve replacement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current methods are used to remove fixation devices, then the procedure can be performed, but surrounding tissues and structures are damaged and visualization is poor

Engineering Contradiction:
Improvetissue safetyVSAvoidvisualization capability
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The cutting mechanism is divided into separate functional components: a guide catheter for navigation, grasping arms for tissue stabilization, and a cutting element for precise incision. This segmentation allows each component to perform its specific function optimally while working together as an integrated system, improving both visualization and tissue safety.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The guide catheter serves as an intermediary device that provides a stable pathway and support structure for delivering the cutting mechanism to the target site. It enables precise positioning and maintains structural integrity during the procedure, facilitating better visualization and reducing tissue damage.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If fixation devices are installed to treat mitral valve regurgitation, then valve function is improved, but further interventional procedures are obstructed

Engineering Contradiction:
Improvevalve functionVSAvoidprocedural flexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The cutting mechanism is designed to perform preliminary incisions on the leaflet tissue before fixation device installation or to modify existing fixation device positions. This preliminary action creates optimal conditions for subsequent procedures, ensuring both effective valve repair and future procedural accessibility.

Inventive Principle:
Principle #10Preliminary action

3Productivity

If cutting is performed on leaflet tissue without precise control, then fixation devices can be removed, but posterior leaflet and sub-valvular structures are damaged

Engineering Contradiction:
Improvefixation device removal efficiencyVSAvoidcollateral tissue damage
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The cutting element is designed to apply cutting action only at the specific local site where leaflet tissue is grasped between the arms. This localized cutting approach ensures that only the intended tissue is incised while surrounding structures such as the posterior leaflet and sub-valvular apparatus remain protected from damage.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The grasping arms automatically position and stabilize the target tissue in preparation for cutting. This self-positioning mechanism ensures that the cutting element engages only the intended tissue without requiring additional manual manipulation, thereby preventing accidental damage to adjacent structures while maintaining high removal efficiency.

Inventive Principle:
Principle #25Self-service

Data Source

PatentEP4146097B1Leaflet grasping and cutting device
Publication Date: 2025.01.15 EVALVE
  • EP4146097B1 patent drawingFigure 1
  • EP4146097B1 patent drawingFigure 2~3
  • EP4146097B1 patent drawingFigure 4

AI summary

A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter and a cutting mechanism routable through the guide catheter. The cutting mechanism includes a cutting arm and a plurality of grasping arms rotatably coupled to the cutting arm. The grasping arms are connected to the cutting arm via a central hinge and are actuatable between a closed position against the cutting arm and an open position where the grasping arms extend laterally away from the cutting arm by rotating about the hinge. Targeted cardiac leaflet tissue may be grasped between the cutting arm and the grasping arms and cut by a cutting element that is attached to or extends through the cutting arm.