Deformable Mitral Valve Clip for Wide Leaflet Capture
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing fixation devices for heart valves struggle to effectively capture and secure leaflets, particularly in cases of larger dynamic gaps and severe mitral regurgitation, while maintaining deliverability through a guide catheter.
Innovation Solution
A fixation device with a deformable frame and flexible arms, featuring deformable flex portions and wing extensions, allows for increased contact patch area and reliable leaflet capture, adaptable to various anatomies and deliverable through a guide catheter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Area of moving object
If the arm width is increased to capture larger dynamic gaps and improve leaflet capture, then the contact patch area increases, but the device cannot be delivered through a standard guide catheter
Solution Approach 1:
The arm is designed with a deformable frame that can dynamically change its width. During delivery, the arm is compressed to a narrow profile to pass through the guide catheter. Upon deployment, the arm expands to a wider configuration to increase the contact patch area for effective leaflet capture. This dynamic transformation allows the device to satisfy both delivery constraints and functional requirements.
Solution Approach 2:
The deformable arm structure allows the wider arm configuration to be nested within the narrower delivery profile. The arm contains internal mechanisms or structural features that enable it to fold or compress itself into a compact form suitable for catheter delivery, then expand to its functional width at the target site.
2Stability of the object's composition
If the arm is made more rigid to maintain structural stability, then the device stability improves, but the device cannot be delivered through a guide catheter
Solution Approach 1:
The arm transitions from a flexible, compressible state during delivery to a rigid, stable state during operation. The deformable frame is designed to maintain structural integrity when deployed, providing the necessary stability for leaflet capture while allowing compression for delivery through the guide catheter.
Solution Approach 2:
The physical parameters of the arm, particularly its rigidity and dimensions, are changed between delivery and operation phases. During delivery, the arm is in a compressed, flexible state. Upon deployment, the arm assumes its intended rigid configuration, achieving the necessary structural stability for its function.
3Device complexity
If the flex portions are made more flexible to enable compression, then the deliverability improves, but the structural integrity during operation may be compromised
Solution Approach 1:
The flex portions are designed to be highly flexible during the delivery phase to allow compression and navigation through the guide catheter. Once deployed, the same flex portions maintain sufficient structural integrity to support the arm's function in capturing and securing the leaflet. The deformable frame's design ensures that flexibility and strength are context-dependent.
Solution Approach 2:
The arm incorporates flexible components, including the deformable frame with flex portions, that can bend and compress during delivery. These flexible structures are engineered to provide the necessary compliance for navigation while maintaining adequate strength and rigidity when deployed to perform the leaflet capture function.
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
Enhances leaflet capture and reduces regurgitation by increasing contact patch area, facilitating secure fixation of heart valve leaflets, even in challenging anatomical conditions, while maintaining transvascular delivery.
Implementation Method 1
a deformable frame with first and second deformable flex portions, each flex portion having a deformed condition and an undeformed condition
Data Source
Figure 1
Figure 2A
Figure 2B~2D
AI summary
Fixation device for fixation of leaflets of a heart valve includes a central assembly and at least one arm moveably coupled relative to the central assembly. The at least one arm includes a deformable frame having a first end and a second end and a longitudinal axis defined therebetween, the second end being moveable between a closed position and an open position. The deformable frame further includes first and second deformable flex portions, each flex portion extending along a respective lateral side of the deformable frame and having a deformed condition and an undeformed condition, and each flex portion having an outer lateral edge. The at least one arm has a maximum deformed arm lateral cross-dimension with the flex portions in the deformed condition.