Mitral Valve Spacer Anchoring for Regurgitation Sealing
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Solution Overview
Problem
Existing techniques for treating mitral regurgitation, such as those described in US'810 and US'989, lack a ventricular anchor that clips around a lower end of a native mitral valve leaflet, necessitating a need for improved devices and methods to effectively seal the native heart valves and prevent or reduce regurgitation.
Innovation Solution
A prosthetic device with a main body portion and a ventricular anchor that clips around a lower end of a native mitral valve leaflet, allowing the device to move laterally during systole to seal the valve and reduce regurgitation, while moving away during diastole to allow blood flow, and optionally featuring a radially compressible and expandable body with anchors to secure the device to both leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If prior devices without ventricular anchors are used, then the device structure is simpler, but the device cannot effectively seal the native heart valves and prevent regurgitation
Solution Approach 1:
The device is divided into distinct functional segments: an atrial anchor portion for securing to the atrial side, a ventricular anchor portion for clipping around the lower end of the leaflet in the ventricle, and a body portion for sealing. This segmentation allows each component to perform its specific function optimally while maintaining overall device effectiveness.
Solution Approach 2:
The ventricular anchor is designed to clip around the lower end of the native mitral valve leaflet, effectively nesting the anchor around the leaflet structure. This nested configuration provides secure attachment while maintaining a relatively compact device profile that does not excessively increase overall complexity.
2Reliability
If the device is designed to move laterally during systole to seal the valve, then regurgitation is reduced, but the device requires complex anchoring mechanisms to remain stable during diastole
Solution Approach 1:
The device incorporates dynamic movement capability where the body portion can move laterally during systole to achieve sealing contact with the leaflet, while the dual-anchor system (atrial and ventricular) provides stable attachment points that accommodate this motion. The anchors are positioned to allow physiological movement while preventing excessive displacement that would compromise sealing.
Solution Approach 2:
Different portions of the device have different functional properties: the atrial anchor provides fixed securement to the atrial side, the ventricular anchor clips around the leaflet lower end with localized grip, and the body portion has the local quality of being able to move and seal against the leaflet surface. This local differentiation of properties allows the device to achieve both stability and sealing effectiveness.
Data Source
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AI summary
This disclosure pertains generally to prosthetic devices and related methods for helping to seal native heart valves and prevent or reduce regurgitation therethrough, as well as devices and related methods for implanting such prosthetic devices. In some cases, a spacer having a single anchor can be implanted within a native heart valve. In some cases, a spacer having dual anchors can be implanted within a native heart valve. In some cases, devices can be used to extend the effective length of a native heart valve leaflet.