Subvalvular Leaflet Support to Reduce Mitral and Tricuspid Regurgitation
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Solution Overview
Problem
Existing medical interventions for Functional Mitral Regurgitation (FMR) and Secondary Tricuspid Regurgitation (STR) focus on replacing or manipulating valve leaflets, but fail to effectively address the underlying ventricular dilation and tethering issues that cause regurgitation, lacking a desired therapeutic effect.
Innovation Solution
A subvalvular device with a supporting portion and anchor portion is used to support the valve leaflet from the ventricular side, untethering it and promoting coaptation without altering the leaflet tissue, utilizing materials like Nitinol or PTFE, and adjustable through minimally invasive surgery or transcatheter approaches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If valve replacement or leaflet manipulation procedures are performed, then regurgitation is addressed, but the underlying ventricular dilation and tethering issues are not resolved
Solution Approach 1:
Instead of addressing regurgitation from the traditional supravalvular or valve-level approach, the invention inverts the approach by placing the support device from the ventricular side (subvalvular position). The device supports the leaflet coaptation surface from beneath, counteracting the tethering forces and promoting proper leaflet alignment without requiring valve replacement or complex leaflet manipulation.
2Shape
If existing intervention methods are used, then valve structure is altered, but normal leaflet mobility and coaptation are not restored
Solution Approach 1:
The support device applies localized support specifically at the leaflet coaptation surface from the subvalvular position. The device's support surface contacts only the necessary portion of the leaflet to promote coaptation, while leaving the rest of the leaflet structure and its natural mobility unchanged. This localized approach restores proper coaptation geometry without restricting normal leaflet movement.
3Reliability
If invasive surgical procedures are performed, then therapeutic effect is achieved, but procedural complexity and invasiveness increase
Solution Approach 1:
The invention extracts the essential therapeutic function (supporting leaflet coaptation) from complex valve replacement or manipulation procedures. By isolating the specific need for subvalvular support and creating a dedicated device for this purpose, the solution simplifies the overall treatment approach while maintaining therapeutic effectiveness, avoiding the need for full valve replacement or complex multi-step procedures.
Data Source
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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.