Subvalvular Support Device for Mitral Valve Leaflet Tethering
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Solution Overview
Problem
Current medical interventions for Functional Mitral Regurgitation (FMR) and Secondary Tricuspid Regurgitation (STR) often involve replacing or repairing heart valves, but these methods fail to effectively address the underlying anatomical issues causing regurgitation, such as ventricular dilation and tethering of valve leaflets, leading to incomplete therapeutic effects.
Innovation Solution
A subvalvular support device is introduced that includes a subvalvular supporting portion and an anchor portion, formed from materials like braided mesh strands or balloons, which is implanted to support the valve leaflet and correct the 'tipping point' mechanism of regurgitation without removing leaflet tissue or deforming the valve annulus, using a transcatheter or minimally invasive approach.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If valve replacement or repair is performed, then regurgitation is reduced, but the underlying anatomical issues (ventricular dilation and tethering) are not addressed
Solution Approach 1:
Instead of approaching the problem from the traditional valve-replacement perspective, this invention inverts the approach by placing the support device from the ventricular side (subvalvular position) to support the leaflet from below, thereby addressing both the valve function and the underlying ventricular anatomy simultaneously
Solution Approach 2:
The subvalvular support device acts as an intermediary structure between the ventricular wall and the valve leaflet, providing mechanical support to counteract tethering forces without directly modifying the leaflet or annulus, thus addressing both regurgitation and anatomical distortion
2Reliability
If leaflet tissue is removed or deformed to repair the valve, then regurgitation is reduced, but the natural leaflet structure is compromised
Solution Approach 1:
This invention extracts the problematic tethering forces from the system by providing external support from the ventricular side, allowing the leaflet to maintain its natural structure and composition while achieving the therapeutic effect of reduced regurgitation
Solution Approach 2:
The support device enables the leaflet to serve its natural function without requiring modification, removal, or deformation of the leaflet tissue itself, allowing the biological structure to maintain its integrity while achieving the therapeutic goal
3Adaptability or versatility
If complex surgical procedures are used to address ventricular anatomy, then anatomical correction is achieved, but procedural complexity and invasiveness increase
Solution Approach 1:
The support device is segmented into distinct functional portions (subvalvular supporting portion and anchor portion), allowing for simplified deployment and positioning while achieving comprehensive anatomical correction through a less invasive transcatheter approach
Data Source
AI summary
An apparatus for partially supporting a leaflet of a regurgitant heart valve includes at least one subvalvular device including a subvalvular supporting portion and an anchor portion. The subvalvular supporting portion and anchor portion are each at least partially formed from at least one of braided mesh strands of a first configuration, braided mesh strands of a second configuration, a balloon, a plurality of longitudinally extending struts, and a plurality of laterally extending struts. A connector neck is interposed longitudinally between, and is attached to both of, the subvalvular supporting portion and the anchor portion. The connector neck penetrates longitudinally through at least one of a base of the leaflet and an annulus of the heart valve at a manufactured puncture site.