Apical Mitral Valve Translocation Device
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Solution Overview
Problem
Current treatments for functional mitral regurgitation (FMR) lack durable and effective repair options, with restrictive mitral annuloplasty and prosthetic valve replacement associated with high recurrence rates and complications such as thromboembolism and infection.
Innovation Solution
A ring-shaped device with an annulus and leaflet portion is used to attach to the native mitral valve, allowing for translocation of the valve towards the apex of the heart, increasing coaptation surface area and addressing geometric issues like annular dilation and leaflet tethering, while preserving the original valve and chordae tendinae.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If restrictive mitral annuloplasty is performed to treat functional mitral regurgitation, then mitral regurgitation is initially effective, but recurrence rate increases over time due to continued adverse remodeling and enlargement of the left ventricle
Solution Approach 1:
The device divides the mitral valve repair into separate functional components: an annuloplasty ring for annular reconstruction, a translocation component for valve positioning, and a leaflet component for coaptation support. This segmentation allows each component to address specific aspects of FMR independently, improving overall durability.
Solution Approach 2:
The invention introduces a translocation dimension by moving the mitral valve apexically towards the ventricular apex, adding a vertical positioning aspect to the traditional planar annuloplasty. This third dimension (apical translocation) addresses the geometric distortion and leaflet tethering that two-dimensional annuloplasty cannot resolve.
2Reliability
If prosthetic valve replacement is performed to achieve durable treatment, then valve replacement is most durable, but complications such as thromboembolism, infection, and mandatory anticoagulation occur
Solution Approach 1:
The invention extracts and preserves the patient's native mitral valve leaflets and chordae tendinae, removing only the diseased annular tissue. This extraction approach allows the native valve components to be repositioned and reused, eliminating the need for prosthetic materials that cause thromboembolism and infection.
Solution Approach 2:
The device discards the dilated and distorted native annulus while recovering and repositioning the healthy native valve leaflets and chordae. The leaflets are attached to the translocation component and repositioned apexically, preserving their native tissue characteristics and avoiding prosthetic complications.
3Ease of manufacture
If MitraClip procedure is used to join middle portion of anterior and posterior leaflets, then a double orifice valve is formed, but substantial number of patients have residual or recurrent mitral regurgitation
Solution Approach 1:
The device performs multiple functions simultaneously: the annuloplasty ring provides annular reconstruction and geometric stabilization, the translocation component repositions the valve apexically, and the leaflet component ensures proper coaptation. This multi-functionality achieves durable treatment without the complexity of multiple separate procedures.
Solution Approach 2:
Instead of joining leaflets together (MitraClip approach), the invention inverts the logic by detaching and repositioning the entire valve apparatus apexically. This inversion transforms the problem from leaflet coaptation deficiency to valve positioning, achieving more durable results.
4Shape
If restrictive mitral annuloplasty is performed to decrease the area of the mitral orifice, then coaptation of leaflets is increased, but adequate surface area for coaptation is not provided due to continued geometric distortion
Solution Approach 1:
The invention addresses the two-dimensional coaptation problem by adding a third dimension (apical translocation). The valve is moved apexically towards the ventricular apex, creating a new spatial relationship that provides adequate coaptation surface area while correcting the geometric distortion caused by left ventricular enlargement.
Solution Approach 2:
The translocation component acts as an intermediary structure between the annuloplasty ring and the valve leaflets. It mediates the geometric distortion by providing a stable anchor point that maintains proper valve orientation and coaptation geometry despite continued ventricular remodeling.
Data Source
AI summary
The present invention provides devices for treating functional mitral regurgitation and methods of use thereof. The devices translocate a subject's mitral valve in an apical direction. The devices thereby treat mitral regurgitation while preserving a subject's original mitral valve and chordae tendinae.