Leaflet Cutting Catheter for Mitral Clip Detachment
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Solution Overview
Problem
Existing treatments for mitral valve regurgitation, such as the MitraClip fixation device, can lead to undesirable regurgitation and obstruct transcatheter mitral valve replacement, with patients being too frail for open-heart surgery, necessitating alternative methods to remove or disable installed fixation devices.
Innovation Solution
A system comprising a steerable guide catheter with a cutting mechanism that can be navigated to a cardiac valve to cut leaflet tissue, allowing detachment of interventional implants like the MitraClip, enabling replacement valve installation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixation device is installed to treat mitral valve regurgitation, then regurgitation is reduced, but the device obstructs subsequent transcatheter mitral valve replacement
Solution Approach 1:
The cutting mechanism is deployed through the guide catheter to cut the leaflet tissue attaching the fixation device to the valve before the replacement valve is installed. This preliminary cutting action disables the fixation device's attachment function, allowing it to be removed or allowing the replacement valve to be installed without interference from the existing device's leaflet attachments
2Ease of repair
If open-heart surgery is performed to remove the fixation device, then complete removal is achieved, but patient trauma and mortality risk increase
Solution Approach 1:
The cutting mechanism is delivered through the guide catheter that has already been positioned in the heart during the minimally invasive procedure. The cutting element is extracted through the same catheter pathway without requiring additional surgical incisions or open-heart surgery, allowing the fixation device to be disabled and removed through the existing access point
3Ease of operation
If the fixation device is left in place, then patient frailty is accommodated with minimally invasive treatment, but further intervention options are limited
Solution Approach 1:
The cutting mechanism cuts the leaflet tissue attachments of the fixation device during the same minimally invasive procedure, preliminarily disabling the device before a replacement valve needs to be installed. This maintains the benefit of minimally invasive treatment while preserving future intervention options by removing the obstruction to replacement valve installation
Data Source
AI summary
A system for cutting leaflet tissue at a cardiac valve may comprise a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve. The system may also include a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control configured to steer the guide catheter to the position above the cardiac valve. Finally, the system may comprise a cutting mechanism routable through the guide catheter and able to be positioned at the distal end of the guide catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve.