Mitral Leaflet Clip With Flexible Arms for Secure Coaptation
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Solution Overview
Problem
Existing medical devices for heart valve repair, such as open heart surgery and transcatheter artificial valve replacement, carry significant morbidity, risk of complications, and require lifelong anticoagulant treatment, while minimally invasive solutions are inadequate for treating mitral regurgitation.
Innovation Solution
A minimally invasive, wire-actuated or rod-actuated fixation device with a center member and flexible arms that capture heart valve leaflets, allowing percutaneous or open-heart surgical repair of mitral regurgitation, featuring a surface texture for retention and adjustable positioning for secure attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a large number of anchor points are used to secure the clip to the valve leaflet, then the security and reliability of the clip are improved, but the complexity of the device and the difficulty of deployment increase
Solution Approach 1:
The anchoring system is divided into multiple discrete anchor points distributed along the clip body, allowing secure attachment at multiple locations on the valve leaflet. This segmentation provides reliable anchoring while maintaining modular simplicity in the deployment mechanism.
2Ease of operation
If the clip is designed to be fully implantable without external delivery, then the procedural complexity is reduced, but the ability to control deployment and positioning is worsened
Solution Approach 1:
A delivery catheter serves as an intermediary device that temporarily holds the clip in a compressed state during insertion and then releases it at the target site. This allows controlled deployment while keeping the final implant simple and fully implantable without requiring complex external control mechanisms.
3Strength
If the clip structure is made rigid to maintain shape and function, then the structural integrity is improved, but the ability to conform to the flexible valve leaflet is worsened
Solution Approach 1:
Different portions of the clip have different mechanical properties: the anchor points and connecting structure provide rigidity and strength for secure attachment, while the body portion incorporates flexibility to conform to the curved surface of the valve leaflet. This local differentiation of mechanical properties resolves the contradiction between structural integrity and adaptability.
Data Source
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AI summary
A fixation device for engaging heart valve leaflets includes a center member with a first end, an opposite second end, and a length extending therebetween, first and second arms each having a first free end and an opposite second end, the second end of each arm extending from the second end of the center member, the first and second arms biased in a first position adjacent the center member and moveable to a second position spaced apart from the center member, and an actuator configured to move the first and second arms from the first position to the second position.