Mitral Valve Leaflet Patches for Regurgitation Repair
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Solution Overview
Problem
Ischemic heart disease leads to mitral regurgitation due to ischemic dysfunction of the papillary muscles and left ventricle dilatation, causing displacement of the papillary muscles and dilatation of the mitral valve annulus, which prevents proper coaptation of the valve leaflets.
Innovation Solution
The system includes leaflet patches, repair chords, and delivery tools for implantation, providing artificial chordae tendineae and leaflet augmentation to facilitate proper coaptation of the mitral valve leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the mitral valve annulus is dilated due to ischemic heart disease, then the left ventricle can accommodate increased blood volume, but the valve leaflets cannot fully coapt causing mitral regurgitation
Solution Approach 1:
The implant divides the leaflet repair into multiple segments by using multiple leaflet patches positioned at different locations on the leaflet surface. Each patch independently reinforces a specific region, allowing the overall leaflet structure to maintain coaptation despite annular dilation and papillary muscle displacement.
Solution Approach 2:
The patent applies leaflet patches with varying characteristics to different regions of the leaflet based on local stress distribution and coaptation requirements. The patches are strategically placed at locations where coaptation failure is most likely to occur, providing enhanced local support where needed while maintaining the natural geometry of the leaflet.
2Reliability
If papillary muscles are displaced due to ischemic dysfunction, then the left ventricle can compensate for ischemic damage, but the chordae tendineae experience increased tension reducing leaflet coaptation
Solution Approach 1:
The implant counteracts the excessive tension in the chordae tendineae by introducing artificial support structures (leaflet patches and repair chords) that bear the tensile load. The repair chords are anchored to the ventricular wall and attached to the leaflet patches, creating a counterbalancing force that reduces the net tension on the chordae and enables proper leaflet coaptation despite papillary muscle displacement.
3Volume of moving object
If mitral regurgitation occurs due to leaflet coaptation failure, then stroke volume increases, but cardiac output decreases and left ventricle weakens
Solution Approach 1:
The patent converts the harmful effect of mitral regurgitation into a beneficial outcome by using the regurgitant flow itself as a guide for implant placement. The areas of the leaflet that experience the most stress and coaptation failure during regurgitation are identified and targeted for reinforcement with leaflet patches, transforming the pathologic flow pattern into information that directs the repair strategy.
Data Source
AI summary
An implant (150) comprises a patch (210), a patch anchor (240), a downstream assembly (300) comprising a winch (320) coupled to a winch anchor (310), and a tether (160) tethering the winch to the patch. A delivery tool (400) has a distal portion that is transluminally advanceable to a heart while the implant is mounted on the delivery tool. The delivery tool has a shaft, a clasp (430), comprising an upstream support and a downstream support, the clasp configured to grasp a portion of a leaflet of a valve of the heart between the upstream support and the downstream support of the clasp, and a driver, configured to anchor the patch to the portion of the leaflet using the patch anchor while the portion of the leaflet remains grasped by the clasp. Other embodiments are also described.