Flexible Valve Clip With Segmented Arms
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Solution Overview
Problem
Current tissue grasping devices for mitral valve repair, such as the MitraClip®, are complex, stiff, and large, leading to premature degradation, require general anesthesia, and have limitations in flexibility and size, which increases procedural risks and trauma to patients.
Innovation Solution
A device with flexible, superelastic outer and inner arms that use a passive closure mechanism to grasp and coapt mitral valve leaflets in a parallel or vertical relationship, allowing for adjustable positioning and reduced entanglement risks, and can be deployed using a smaller catheter size, enabling procedures under local anesthesia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If conventional forceps with rigid shafts are used, then structural strength is maintained, but flexibility and adaptability to curved anatomical structures are lost
Solution Approach 1:
The forceps shaft is divided into multiple segments that can move relative to each other, allowing the shaft to bend and adapt to curved anatomical structures while maintaining overall structural integrity through the articulation joints
Solution Approach 2:
The forceps shaft transitions from a rigid static structure to a dynamic flexible structure with articulation joints that allow controlled bending and shaping to match curved anatomical surfaces
2Adaptability or versatility
If the forceps shaft is made flexible to match curved anatomy, then adaptability improves, but structural strength and rigidity deteriorate
Solution Approach 1:
The shaft is segmented into multiple rigid sections connected by articulation joints, allowing flexibility through joint movement while maintaining strength within each rigid segment
Solution Approach 2:
The forceps shaft uses a composite construction combining rigid materials for structural strength with flexible articulation joints for adaptability, creating a hybrid structure that exhibits both properties
3Reliability
If the grasping force is increased to secure tissue firmly, then grasping reliability improves, but tissue damage and trauma increase
Solution Approach 1:
The forceps tips feature localized quality changes with curved surfaces that conform to tissue shape and distributed contact areas that reduce pressure concentration, allowing firm grasping without localized tissue damage
Solution Approach 2:
The forceps tips utilize changes in geometric parameters including curved surfaces and specific radii of curvature to optimize the contact mechanics between forceps and tissue, enabling secure grasping with reduced trauma
4Manufacturing precision
If the forceps tips are made curved to match tissue anatomy, then grasping precision improves, but manufacturing complexity increases
Solution Approach 1:
The curved forceps tips are manufactured as separate components that can be precisely formed and then assembled to the shaft, allowing complex curvature to be achieved through modular manufacturing rather than monolithic fabrication
Data Source
AI summary
A clip for immobilizing leaflets of a cardiac or venous valve includes a hub having a pair of tangle resistant spring-biased outer arms coupled to an inferior end of the hub and a pair of tangle resistant spring-biased inner arms adjacent to the outer arms and coupled to a superior end of the hub. A delivery catheter may be used to position the valve clip adjacent a target valve while the outer and inner arms are biased in an opened position relative to each other. After the valve leaflets are located between the opened outer and inner arms, the biasing forces may be released to allow the clip to self-close the clip over the valve leaflets.