Transcatheter Leaflet Plication for Mitral Regurgitation
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Solution Overview
Problem
Existing treatments for mitral regurgitation, such as surgical repair or replacement of heart valves, are invasive and pose significant risks, particularly for elderly and frail patients, while transcatheter techniques lack effective methods to address excessive slack in heart valve leaflets causing regurgitation.
Innovation Solution
A transcatheter leaflet-plicating mechanism with leaflet-capture arms and a helical needle is used to plicate and suture the native heart valve leaflets, reducing slack and improving coaptation without open-heart surgery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical repair or replacement of heart valves is performed, then valve functionality is improved, but invasiveness and surgical risk increase
Solution Approach 1:
The patent replaces open-heart surgery with a transcatheter-based mechanical system that uses a delivery catheter, plicating mechanism, and suture device to repair the mitral valve through minimally invasive percutaneous access, eliminating the need for thoracotomy and cardiopulmonary bypass
Solution Approach 2:
The patent introduces a transcatheter delivery system as an intermediary between the operator and the heart valve, allowing the plicating mechanism to be advanced through catheters into the left atrium and ventricle to perform leaflet plication without direct surgical exposure
2Object-affected harmful factors
If transcatheter techniques are used, then invasiveness is reduced, but effectiveness in addressing excessive slack in leaflets is insufficient
Solution Approach 1:
The patent employs a plicating mechanism that pre-folds or plicates the excessive leaflet tissue before suturing, creating a compacted structure that reduces slack and improves coaptation. The mechanism includes forceps or clamps that grasp and fold the leaflet edges together in a controlled manner
Solution Approach 2:
The patent applies localized plication to specific regions of the leaflet where excessive slack is present, rather than treating the entire valve structure. The plicating mechanism targets specific segments of the leaflet to create focal points of reduced slack that improve overall coaptation
3Reliability
If leaflet plication is performed, then coaptation is improved, but device complexity increases
Solution Approach 1:
The patent divides the plication process into discrete operational steps: (1) positioning the plicating mechanism, (2) grasping the leaflet with forceps, (3) folding or plicating the leaflet edges, (4) securing with a suture device, and (5) releasing the mechanism. This segmentation allows for manageable complexity in a minimally invasive procedure
Data Source
AI summary
An apparatus for repairing a leaflet of a valve of a heart comprises a leaflet-plicating tool that comprises two arms that are pivotable with respect to each other. Each arm comprises a shaft and a leaflet-engaging member that is movable with respect to the shaft. The tool is configured to extend each arm over the leaflet, and to capture a portion of the leaflet between the arms by engaging a free edge of the leaflet with each of the arms by moving the leaflet-engaging member with respect to the shaft. Subsequently pivoting the arms toward each other form a plication in the captured portion of the leaflet. The plication is then secured and the tool is withdrawn from the heart, leaving the plication secured. Other embodiments are also described.