Leaflet Restraint Net Anchors Mitral Valve Prolapse
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Solution Overview
Problem
Mitral valve degenerative diseases such as prolapse and flail lead to mitral regurgitation, heart failure, atrial fibrillation, and pulmonary hypertension, as existing treatments fail to effectively limit prolapse without occluding blood flow.
Innovation Solution
A non-blood-occlusive net with tissue-penetrating annulus anchors and a ventricular anchor is used to restrain the native leaflet, limiting prolapse into the atrium without obstructing blood flow, and is anchored to specific points on the annulus and ventricle to maintain the native leaflet's position.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic leaflet or valve is used to treat mitral valve degenerative disease, then prolapse is limited, but blood flow is occluded
Solution Approach 1:
The invention extracts only the necessary restraining function from a complete prosthetic valve, using a separate restraint device that limits prolapse without replacing the native leaflet's blood flow function. The net and anchors provide mechanical support to prevent excessive leaflet displacement while leaving the natural valve structure intact for normal blood flow.
Solution Approach 2:
The net acts as an intermediary element between the annulus and the ventricular anchor, providing a flexible structure that distributes the restraining force across the leaflet without creating a rigid barrier to blood flow. This intermediary structure limits prolapse while maintaining physiological flow patterns.
2Reliability
If existing treatments are used to limit prolapse, then mitral regurgitation is reduced, but blood flow obstruction occurs
Solution Approach 1:
The invention separates the regurgitation prevention function from the blood flow function by using a minimal intervention approach. The net and anchor system provides just enough support to prevent leaflet reversal during systole while maintaining full blood flow capacity during diastole, avoiding the obstruction inherent in traditional prosthetic replacements.
3Object-generated harmful factors
If a non-blood-occlusive net is used to restrain the leaflet, then blood flow is maintained, but prolapse limitation effectiveness is reduced
Solution Approach 1:
The net functions as a flexible thin film structure that can adapt to the dynamic motion of the leaflet while providing restraining force. The flexibility allows the net to conform to physiological movements and maintain effectiveness without creating rigid obstructions to blood flow, achieving both flow maintenance and reliable prolapse limitation.
Solution Approach 2:
The restraint system is designed to be dynamic rather than static, with the net and anchors working together to provide adaptive support that responds to changing hemodynamic conditions. The system maintains effectiveness across different cardiac cycles and physiological states while preserving natural blood flow patterns.
Data Source
AI summary
A leaflet restraint (20) includes a non-blood-occlusive net (30), which is configured to at least partially cover an atrial surface (32) of a single native cardiac leaflet (34) of a native atrioventricular valve (36) of a heart (38). Two or more tissue-penetrating annulus anchors (40) are fixed to an annular side (42) of the net (30), and are configured to be anchored to an annulus (44) of the native atrioventricular valve (36) along or within 1 cm of a portion of the annulus (44) to which the single native cardiac leaflet (34) attaches. A ventricular anchor (50) is configured to be anchored to a ventricle (54) of the heart (58) so as to anchor a ventricular end (52) of the net (30) to the ventricle (54). The leaflet restraint (20) is configured, when anchored in place at least partially covering the atrial surface (32) of the single native cardiac leaflet (34), to limit prolapse of the single native cardiac leaflet (34) into an atrium (56) of the heart (38). Other embodiments are also described.