Mitral Leaflet Cutting Guide for Precise LVOT Obstruction Prevention
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Solution Overview
Problem
Existing transcatheter procedures for heart valve modification, such as transcatheter mitral valve replacement (TMVR), face challenges in preventing left ventricle outflow tract (LVOT) obstruction by effectively cutting or modifying mitral valve leaflets without causing damage to neighboring tissues.
Innovation Solution
A heart valve tissue cutting device with a pivoted cutting guide arm and actuator wires, allowing controlled cutting or splitting of mitral valve leaflets by pivoting and protruding a blade through a slot, ensuring precise and smooth tissue modification.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a cutting device is used to modify mitral valve leaflets, then the risk of LVOT obstruction is reduced, but the risk of damage to neighboring tissues increases
Solution Approach 1:
A cutting guide arm is introduced as an intermediary component between the cutting element and the target tissue. The guide arm with its slot defines a precise cutting path, allowing the blade to follow a predetermined trajectory that separates the cutting action from surrounding tissues, thus protecting neighboring structures while achieving the necessary leaflet modification
Solution Approach 2:
The cutting device is segmented into distinct functional components: a housing, a pivoted cutting guide arm, and a cutting element. This segmentation allows the guide arm to be positioned and oriented independently to guide the blade along a safe path, while the cutting element remains isolated and controlled, reducing the risk of uncontrolled damage to adjacent tissues
2Manufacturing precision
If a pivoted cutting guide arm with actuator wires is used, then cutting precision is improved, but device complexity increases
Solution Approach 1:
The cutting guide arm is designed to be pivoted rather than fixed, allowing it to dynamically adjust its position and orientation. The actuator wires enable controlled movement of the guide arm to the required angle, providing the flexibility needed for precise cutting while maintaining a relatively simple mechanical structure based on pivot points and wire actuators
3Productivity
If the blade protrudes from the housing during cutting, then cutting effectiveness is improved, but the risk of tissue damage increases
Solution Approach 1:
The cutting guide arm is positioned and the cutting path is established before the blade protrudes from the housing. The guide arm with its pre-formed slot creates a predetermined safe pathway, allowing the blade to protrude and perform effective cutting while being constrained to follow the pre-planned trajectory that avoids surrounding tissues
Data Source
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AI summary
A heart valve tissue cutting device includes a housing formed with an elongate opening, a cutting guide arm pivoted to the housing at a distal pivot, the cutting guide arm being formed with a slot, and a first actuator wire coupled to the cutting guide arm. Movement of the first actuator wire causes the cutting guide arm to pivot about the distal pivot. A cutting element having a blade is coupled to a track link which is arranged to travel along a track in the housing. A second actuator wire is coupled to the track link. Movement of the second actuator wire causes the track link and the cutting element to move distally or proximally along the track. When the track link is at a proximal portion of the track, the blade does not protrude out of the housing and when the track link is not at the proximal portion of the track, the blade protrudes out of the housing.