Anterior Mitral Leaflet Laceration Catheter for LVOT Relief
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Solution Overview
Problem
Current transcatheter mitral valve replacement (TMVR) procedures face challenges with left ventricular outflow tract (LVOT) obstruction due to the close relationship between the anterior mitral leaflet and the interventricular septum, leading to high morbidity and mortality, particularly in minimally invasive techniques like LAMPOON, which are technically challenging and risky.
Innovation Solution
A catheter system with an elongate shaft and a positionable introducer featuring a distal end cutting portion, including lumens for a balloon and a wire, allows for controlled laceration of the anterior mitral valve leaflet using mechanical or electrosurgical methods, ensuring precise and safe splitting.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If transcatheter mitral valve replacement (TMVR) is performed, then mitral valve disease can be treated minimally invasively, but left ventricular outflow tract (LVOT) obstruction occurs due to the close relationship between the anterior mitral leaflet and the interventricular septum
Solution Approach 1:
The patent applies preliminary action by intentionally lacerating the anterior mitral leaflet before TMVR implantation. This pre-procedural modification prevents the leaflet from being pushed toward the interventricular septum during valve deployment, thereby preventing LVOT obstruction before it occurs. The laceration is performed using a catheter-based cutting device that creates a controlled split in the leaflet tissue.
Solution Approach 2:
The patent extracts the problematic portion of the anterior mitral leaflet by lacerating and removing a segment of the leaflet tissue. This extraction eliminates the tissue that would otherwise be displaced by the new valve and cause LVOT obstruction, while preserving the functional portions of the mitral valve apparatus.
2Object-affected harmful factors
If the LAMPOON technique (focused radiofrequency energy) is used to lacerate the anterior mitral leaflet, then LVOT obstruction can be prevented, but the procedure becomes technically challenging and time consuming
Solution Approach 1:
The patent replaces the complex radiofrequency energy system with a simpler mechanical cutting mechanism. A catheter-mounted blade or cutting element physically lacerates the leaflet tissue through direct mechanical contact, eliminating the need for sophisticated energy delivery systems, specialized catheters, and complex procedural techniques while achieving the same protective effect.
Solution Approach 2:
The patent segments the anterior mitral leaflet by creating a controlled laceration that divides the leaflet into separate portions. This segmentation allows the problematic tissue to be removed or repositioned while preserving the functional leaflet tissue, achieving LVOT protection through simple physical division rather than complex energy-based methods.
3Object-affected harmful factors
If the anterior mitral leaflet is lacerated using existing catheters and guidewires, then LVOT obstruction can be relieved, but uncontrolled laceration force may damage nearby structures
Solution Approach 1:
The patent introduces a specialized catheter-mounted cutting device as an intermediary between the operator and the leaflet tissue. This device provides controlled mechanical cutting through a blade or cutting element that is precisely positioned and activated only when properly engaged with the target tissue, preventing uncontrolled laceration forces and protecting nearby structures from accidental damage.
Solution Approach 2:
The patent changes the laceration mechanism from uncontrolled mechanical force (existing catheters and guidewires) to controlled mechanical cutting with a dedicated blade. The cutting device allows precise control of laceration depth, direction, and extent through mechanical engagement features, transforming an unreliable process into a controllable one with defined parameters for safe tissue division.
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
The catheter system provides a minimally invasive, fast, and reproducible method to prevent or relieve LVOT obstruction by precisely lacerating the anterior mitral leaflet, reducing procedural risks and complications.
Implementation Method 1
the cutting portion is configured to deliver controlled laceration force to target tissue
Implementation Method 2
The cutting portion is configured to deliver controlled laceration force via mechanical force alone or in combination with transmittable energy
Data Source
AI summary
The disclosed apparatus, systems and methods relate to an anterior mitral valve leaflet laceration catheter. The catheter has a plurality of lumens so as to allow for the introduction of the device via a guide wire, the inflation of a balloon and the manipulation of an introducer having a curved distal end cutting portion that can be rotated into a charged position for the laceration of the anterior mitral valve leaflet.