Mitral Valve Repair Apparatus with Infra-Annular Support
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Solution Overview
Problem
Current surgical methods for treating mitral regurgitation, such as annuloplasty, often result in recurrence due to left ventricle dilation and tethering of mitral leaflets, leading to ongoing valve regurgitation issues.
Innovation Solution
An apparatus comprising a substantially annular support member with infra-annular support members and anchoring elements that receive prosthetic chordae tendineae for attachment to papillary muscles, providing sub-valvular leaflet support and cardiac remodeling to prevent or reduce regurgitation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical annuloplasty is performed to correct mitral regurgitation, then valve leaflet coaptation is improved, but recurrence of mitral regurgitation occurs due to continued left ventricle dilation and remodeling
Solution Approach 1:
The support system is divided into multiple components: an annular support member that attaches to the mitral annulus, and one or more infra-annular support members that extend into the left ventricle. This segmentation allows independent stabilization of the annulus and the ventricular wall, addressing both the valve coaptation issue and the ventricle dilation issue simultaneously.
Solution Approach 2:
The infra-annular support members are positioned and secured to the left ventricular wall before the annular support member is fully activated. This preliminary action provides immediate structural support to prevent ventricle dilation, creating a stable foundation that maintains the corrected valve geometry over time.
2Reliability
If an undersized, complete, and rigid annuloplasty ring is used to reduce mitral annulus diameter, then leaflet coaptation is achieved, but the device complexity increases and may not adapt to ongoing ventricular remodeling
Solution Approach 1:
Instead of using a single complex rigid ring, the invention employs a segmented approach with an annular support member and separate infra-annular support members. This reduces the complexity of each individual component while achieving the same functional outcome of leaflet coaptation, and allows for greater adaptability to ventricular remodeling.
Solution Approach 2:
The support members are designed with flexible or adjustable characteristics that allow them to adapt to ongoing left ventricle remodeling. The infra-annular support members can move with ventricular contraction and dilation, maintaining their support function without requiring an overly complex rigid structure.
3Reliability
If complete correction of mitral regurgitation is achieved surgically, then valve function is restored, but recurrence occurs in 25% of patients due to continued ventricular dilation
Solution Approach 1:
The support system addresses both the valve level and the ventricular level separately, preventing recurrence by stabilizing the root cause (ventricular dilation) in addition to correcting the valve geometry. This dual-level approach significantly improves long-term stability compared to annuloplasty alone.
Solution Approach 2:
The infra-annular support members provide preemptive support to the left ventricular wall, cushioning it against future dilation and remodeling. This prior cushioning prevents the ventricle from expanding and tethering the leaflets again, thereby preventing recurrence of mitral regurgitation.
Data Source
AI summary
A method for treating regurgitation of blood flow through a diseased heart valve is provided. The diseased heart valve including an annulus, an anterior valve leaflet, a posterior valve leaflet and a subvalvular apparatus. The method includes providing an apparatus comprising a substantially annular support member, at least one infra-annular support member securely connected thereto, and at least one anchoring element associated with the at least one infra-annular support member. The method further includes attaching the substantially annular support member to the annulus of the diseased heart valve and attaching proximal and distal ends of a prosthetic chordae tendineae to the at least one anchoring element and a papillary muscle, respectively, so that the papillary muscle is caused to move medially.