Transcatheter Cutting Mechanism for Fixation Device Removal
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Solution Overview
Problem
Patients with mitral valve regurgitation who have undergone fixation device implantation often experience persistent or recurrent issues, and these devices can obstruct transcatheter valve replacement, leaving them without viable options for further treatment, especially if they are frail and cannot tolerate open-heart surgery.
Innovation Solution
A system comprising a guide catheter and a cutting mechanism that can be positioned at a cardiac valve to selectively cut leaflet tissue, allowing for the removal or disablement of existing fixation devices, such as the MitraClip, thereby addressing persistent mitral valve regurgitation and enabling further intervention without the need for open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a fixation device is installed to treat mitral valve regurgitation, then the regurgitation is reduced, but the device obstructs future transcatheter valve replacement options
Solution Approach 1:
The cutting mechanism is designed to selectively cut the fixation device from the valve leaflets, extracting the disturbing element (fixation device) that blocks future treatment options while preserving the valve leaflets for potential replacement
2Ease of repair
If open-heart surgery is performed to remove the fixation device, then the device can be removed, but the patient experiences high trauma and mortality risk
Solution Approach 1:
The mechanical cutting mechanism delivers cutting elements through a catheter to sever the fixation device attachments, replacing the need for mechanical open-heart surgery with a minimally invasive transcatheter approach that avoids chest opening and cardiopulmonary bypass
Solution Approach 2:
The cutting mechanism is nested within a guide catheter system, allowing the cutting elements to be delivered through the vascular system to the heart valve without requiring external surgical access, thus minimizing patient trauma
3Ease of operation
If the fixation device is left in place, then the patient avoids additional surgery, but transcatheter valve replacement becomes impossible
Solution Approach 1:
The cutting mechanism performs preliminary action by severing the fixation device attachments before attempting valve replacement, clearing the obstruction that would otherwise prevent successful implantation of a replacement valve
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
Enables the effective removal of fixation devices, potentially improving mitral valve function and allowing for alternative treatment options, including transcatheter mitral valve replacement, while minimizing trauma and risk for patients.
Implementation Method 1
a cutting mechanism routable through the guide catheter and configured to extend from the distal end of the guide catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve
Data Source
AI summary
A device configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter having a proximal end and a distal end, the guide catheter being positionable at a cardiac valve. The device may further include a cutting mechanism routable through the guide catheter and configured to extend from the distal end of the guide catheter, the cutting mechanism configured to cut a portion of leaflet tissue of the cardiac valve. Finally, the device may comprise a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the cutting mechanism such that the at least one control is configured to provide selective actuation of the cutting mechanism.