Ringless Web Mitral Valve Repair Tensioning
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Solution Overview
Problem
Current surgical techniques for repairing mitral valve regurgitation, particularly degenerative and functional mitral valve regurgitation, face challenges in achieving broad acceptance as a preferred method, especially for patients with irregular valve anatomy and high-risk populations, leading to complications like valve leaks and prolonged recovery times.
Innovation Solution
A ringless web is anchored below and above the valve plane, utilizing tensioning mechanisms to restrain leaflets and promote natural coaptation, preventing prolapse and regurgitation, and can be chronically implanted in a beating heart using various anchor systems and materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional valve repair techniques are used, then valve regurgitation can be treated, but the procedures are highly invasive and result in long recovery times
Solution Approach 1:
The repair device is divided into multiple independent components: a delivery catheter, an expandable frame, and coaptation material. This segmentation allows for minimally invasive delivery through the catheter while enabling effective valve repair through the expanded frame and material, thus reducing recovery time while maintaining repair effectiveness
Solution Approach 2:
The expandable frame acts as an intermediary between the delivery catheter and the valve leaflets. It transitions the device from a flexible delivery configuration to a rigid support structure that provides mechanical assistance for leaflet coaptation, achieving effective repair with minimal invasive delivery
2Reliability
If replacement valves are used, then valve function is restored, but the irregular valve annulus shape causes difficulty in fixing and orienting the replacement valve
Solution Approach 1:
The frame is designed to be expandable from a compressed delivery state to an expanded support state. This dynamic transformation allows the device to adapt to the irregular valve annulus geometry, providing fixation and orientation assistance without requiring the valve to be pre-formed, thus improving ease of operation while maintaining reliable valve function restoration
Solution Approach 2:
The device changes its physical parameters (size, shape, rigidity) during deployment. The frame expands from a small delivery configuration to a larger support configuration, allowing it to conform to the irregular valve annulus shape and provide stable fixation, thereby improving ease of operation while ensuring reliable valve function restoration
3Reliability
If artificial chordae are implanted to correct mitral valve regurgitation, then leaflet prolapse can be corrected, but the technique has not achieved general acceptance as the preferred repair method
Solution Approach 1:
The repair device combines multiple functions in a single system: delivery through catheter, mechanical support via expandable frame, and coaptation assistance through material. This multi-functionality addresses various causes of mitral valve regurgitation (degenerative and functional) and can be adapted to different valve anatomies, improving both reliability of prolapse correction and adaptability to achieve broad acceptance
Data Source
AI summary
A ringless web is configured to repair heart valve function in patients suffering from degenerative mitral valve regurgitation (DMR) or functional mitral valve regurgitation (FMR). In accordance with various embodiments, a ringless web can be anchored at one or more locations below the valve plane in the ventricle, such as at a papillary muscle, and one or more locations above the valve plane, such as in the valve annulus. A tensioning mechanism connecting the ringless web to one or more of the anchors can be used to adjust a tension of the web such that web restrains the leaflet to prevent prolapse by restricting leaflet motion to the coaptation zone and/or promotes natural coaptation of the valve leaflets.