Leaflet Coaptation-Assist Device Anchoring via Ventricular Loops
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Solution Overview
Problem
Mitral and tricuspid valve prolapse lead to poor coaptation and leakage, resulting in complications such as mitral regurgitation, congestive heart failure, and cardiac arrest, for which existing treatments are inadequate in preventing valve prolapse and enhancing coaptation.
Innovation Solution
A leaflet coaptation-assist device with a coaptation-assist surface and tissue anchors is placed at or near the flexural level of atrioventricular valves to limit leaflet movement and enhance coaptation, using non-tissue-piercing anchors like ventricular loops or tissue-piercing anchors to secure the device, thereby preventing prolapse and minimizing leakage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a patch or barrier is placed at the flexural level to limit leaflet movement, then valve coaptation is enhanced and prolapse is reduced, but the device complexity increases due to the need for tissue anchors and coaptation-assist surfaces
Solution Approach 1:
The device is divided into distinct functional components: a coaptation-assist surface for enhancing leaflet coaptation, tissue anchors for securing the device to the annulus, and ventricular loops for additional anchoring. This segmentation allows each component to perform its specific function while maintaining overall device effectiveness in preventing valve prolapse and improving coaptation.
Solution Approach 2:
The coaptation-assist surface acts as an intermediary element between the leaflets and the annulus. It provides a barrier that limits excessive leaflet movement into the atrium while still allowing controlled motion at the flexural level, thereby mediating between the need for prolapse prevention and the need to maintain valve flexibility.
2Object-affected harmful factors
If non-tissue-piercing anchors like ventricular loops are used to couple the device to the ventricular wall, then tissue damage is reduced, but the anchoring force and stability may be insufficient compared to tissue-piercing anchors
Solution Approach 1:
The ventricular loops are configured as flexible, loop-shaped structures that can be positioned around the ventricular wall without piercing the tissue. These loops utilize friction and radial force to achieve anchoring, providing a non-invasive alternative that reduces tissue damage while maintaining sufficient stability through their flexible contact with the ventricular surface.
3Reliability
If the coaptation-assist surface is positioned at or below the leaflet hinge line, then leaflet movement is limited effectively, but the natural leaflet motion may be overly constrained
Solution Approach 1:
The coaptation-assist surface is strategically positioned at or below the leaflet hinge line, the specific location where prolapse occurs. This localized placement provides effective prolapse prevention at the critical point without unnecessarily constraining the broader natural motion of the leaflets. The surface acts as a barrier only where needed, allowing controlled motion elsewhere.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device effectively enhances leaflet coaptation, reduces valve prolapse, and minimizes leakage, improving the function of both native and prosthetic valves, thereby addressing the complications associated with mitral and tricuspid valve insufficiency.
Implementation Method 1
one or more ventricular loops, which are configured to couple the leaflet coaptation-assist device to a ventricular wall by radial force and friction
Data Source
AI summary
A leaflet coaptation-assist device (920, 1020, 1120) is provided for promoting valve coaptation of leaflets (22) of an atrioventricular valve, the leaflet coaptation-assist device (920, 1020, 1120) including a coaptation-assist surface (964, 1064, 1164) and one or more tissue anchors, which are configured to anchor the leaflet coaptation-assist device (920, 1020, 1120) in place within the heart, such that the coaptation-assist surface (964, 1064, 1164) is located at or below the leaflet hinge line and contacts an atrial side of the leaflets (22) during ventricular systole, thereby enhancing leaflet coaptation. In some configurations, the one or more tissue anchors include one or more ventricular loops (988, 1088, 1188), which are configured to couple the leaflet coaptation-assist device (920, 1020, 1120) to the ventricular wall by radial force and friction. Other embodiments are also described.