Mitral Valve Sealing Device With Adjustable Leaflet Anchoring
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Solution Overview
Problem
Existing treatments for mitral regurgitation, such as stitching native mitral valve leaflets or using spacers with single or dual anchors, are inadequate for effectively preventing or reducing regurgitation, particularly in the mitral valve, due to challenges in aligning and securing the devices during heart contraction phases.
Innovation Solution
A prosthetic device with a spacer body and anchor portions that can be moved between compressed and expanded configurations, allowing for adjustable positioning and securement to native leaflets using self-expanding materials like Nitinol, which can be delivered via a transvascular technique to minimize regurgitation by capturing leaflets between the anchor and spacer body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stitching native mitral valve leaflets or using spacers with single or dual anchors is used, then the treatment approach is simple, but the effectiveness in preventing or reducing regurgitation is inadequate
Solution Approach 1:
The prosthetic device is divided into multiple functional segments: an anchor portion with multiple anchors, a spacer body portion, and a cover portion. This segmentation allows each component to perform its specific function independently, improving overall reliability while maintaining manageable complexity through modular design
Solution Approach 2:
The device employs a nested structure where the anchor portion is positioned within the left ventricle, the spacer body is positioned within the left atrium, and the cover portion envelops both components. This nesting approach consolidates multiple functional elements into a compact integrated device that achieves superior regurgitation prevention without proportionally increasing complexity
2Ease of operation
If a prosthetic device is delivered via transvascular technique, then the invasiveness is reduced, but the precision in positioning and securing the device during heart contraction is challenging
Solution Approach 1:
The device incorporates dynamic elements including the expandable anchor portion with multiple anchors that can engage the native valve tissue at different positions, and the cover portion that can be adjusted to accommodate varying degrees of leaflet coaptation. This dynamic design allows the device to adapt to the moving heart structures during contraction phases, achieving precise positioning without requiring extremely tight pre-procedure sizing
Solution Approach 2:
The device utilizes parameter changes in the form of expandable and adjustable components. The anchor portion can be expanded to different diameters, the spacer body can be positioned at varying depths, and the cover portion can be adjusted to different configurations. These parameter adjustments enable precise positioning during implantation while maintaining the benefits of transvascular delivery
3Adaptability or versatility
If the device is designed to adjust to varying degrees of leaflet coaptation, then the adaptability is improved, but the device structure becomes more complex
Solution Approach 1:
The cover portion serves multiple functions: it envelops the anchor and spacer components, provides a sealing surface against the native valve tissue, and can be adjusted to accommodate varying degrees of leaflet coaptation. This multi-functionality achieves high adaptability without requiring separate adjustment mechanisms for each function, thereby limiting the increase in overall device complexity
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 reduces mitral regurgitation by adjusting to varying degrees of leaflet coaptation, minimizing the orifice area, and securing leaflets together, even during heart contraction phases, thus improving valve functionality without the need for precise pre-procedure sizing.
Implementation Method 1
allowing for adjustable positioning and securement to native leaflets using self-expanding materials like Nitinol
Data Source
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AI summary
In one representative embodiment, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion, wherein the prosthetic device is movable between a compressed configuration, in which the spacer body portion is radially compressed and is axially spaced relative to the anchor portion, and an expanded configuration, in which the spacer body portion expands radially outwardly relative to the compressed configuration and overlaps at least a portion of the anchor portion.