Flexible Canopy Valve Repair Tensioning
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Solution Overview
Problem
Current treatments for mitral valve regurgitation due to a prolapsing leaflet are invasive, have significant drawbacks in terms of efficacy and safety, and may compromise future treatments by reducing the cross-sectional area for blood flow or altering the valve anatomy.
Innovation Solution
A system comprising a flexible canopy and an elongated tether, where the tether is placed under tension to prevent leaflet prolapse, allowing the canopy to coapt with opposing leaflets, thereby minimizing regurgitation without reducing blood flow or altering the valve's cross-sectional area, and is adjustable to accommodate anatomical changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If re-sectioning of the prolapsed tissue or chordae repair is performed, then the valve regurgitation is treated, but the valve anatomy is altered and future treatments may be compromised
Solution Approach 1:
The system employs a adjustable tension mechanism that allows dynamic modification of the canopy's positioning and tensioning. The tensioning element can be adjusted to accommodate anatomical changes over time, enabling the same device to maintain effectiveness while preserving the valve's natural anatomy for potential future treatments.
Solution Approach 2:
The system changes the parameter of tissue tension by applying controlled tension to the tensioning element, which adjusts the canopy's position and its relationship with the prolapsed leaflet. This parameter adjustment allows the system to treat regurgitation without permanently altering the valve's structural parameters, preserving anatomy for future treatments.
2Reliability
If placement of a new valve or attachment of a clip is performed, then the valve regurgitation is treated, but the cross-sectional area for blood flow is reduced
Solution Approach 1:
The system introduces an intermediary element (the canopy supported by the tensioning element) that mediates between the prolapsed leaflet and the remaining healthy tissue. This intermediary structure provides support and coaptation without requiring removal or replacement of the native valve leaflets, thereby preserving the cross-sectional area for blood flow while effectively treating regurgitation.
3Reliability
If the valve is repaired by traditional methods, then regurgitation is reduced, but the valve becomes less efficient and elasticity is lost
Solution Approach 1:
The system allows the valve's own elastic properties to be utilized by applying tension through the tensioning element to the canopy, which then works with the natural elasticity of the valve tissue to achieve coaptation. This self-service approach treats regurgitation while preserving and utilizing the valve's inherent elastic properties rather than compromising them.
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 system effectively reduces or eliminates valvular regurgitation while maintaining the valve's functionality and accessibility for future treatments, ensuring efficient blood flow and minimizing complications.
Implementation Method 1
The elongated tether includes an inelastic portion and an elastic portion that is at least as long as the inelastic portion
Data Source
Figure 1
Figure 2A~2B
Figure 2C~2D
AI summary
A system for treating valvular regurgitation in a heart valve includes a flexible canopy and an elongated tether including an elastic portion and an inelastic portion. When the system is in a deployed configuration, a proximal end of the flexible canopy is coupled to an annulus of the heart valve and a distal end of the elongated tether is coupled to a ventricle. The flexible canopy is configured to overlay a first native leaflet of the heart valve, and tension on the elongated tether is applied and/or adjusted to prevent the first leaflet from prolapsing, to maximize coaptation of the flexible canopy with a second native leaflet of the heart valve, and to minimize regurgitation of the heart valve.