Steerable Catheter Leaflet Cutting for Mitral Implant Removal
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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, leaving patients with no viable options for further improvement, especially for those who are too frail for open-heart surgery.
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 for the removal or detachment of interventional implants like the MitraClip, facilitating the installation of an artificial mitral valve.
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 invention divides the problem into two phases: first installing the fixation device to treat regurgitation, then using a cutting mechanism to segment and remove the device when replacement is needed. This allows the system to adapt to changing patient needs over time.
Solution Approach 2:
The fixation device is designed to be temporary and removable. When transcatheter mitral valve replacement becomes necessary, the cutting mechanism allows the device to be discarded by cutting the leaflet tissue, enabling the next therapeutic option.
2Ease of repair
If open-heart surgery is performed to remove the fixation device, then the device can be removed, but the patient suffers high mortality and morbidity
Solution Approach 1:
The invention replaces the mechanical/open surgical approach with a transcatheter-based cutting mechanism. The cutting device is delivered through a catheter and uses a cutting element (such as a laser or mechanical blade) to cut the leaflet tissue and remove the fixation device without requiring chest opening or cardiopulmonary bypass.
3Object-affected harmful factors
If the fixation device is left in place, then the patient avoids additional surgical trauma, but the device blocks further treatment options
Solution Approach 1:
The system transitions from a static, permanent fixation device to a dynamic, removable one. The cutting mechanism enables the system to adapt its configuration based on the patient's evolving clinical needs, allowing removal when replacement becomes necessary.
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.