Mitral Valve Sealing Structure With Paddles and Barbed Clasps
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Solution Overview
Problem
Existing treatments for mitral valve regurgitation, such as surgical stitching and catheter-delivered clips, are inadequate for effectively sealing the native mitral valve and can cause stress on patient leaflets, leading to longer operation times and restricted blood flow.
Innovation Solution
An implantable prosthetic device with a coaption element and anchoring means, featuring moveable paddles and barbed clasps, is designed to be deployed via a delivery sheath, capturing native leaflets to form a seal and prevent regurgitation by securing the device to the mitral valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical stitching or catheter-delivered clips are used to treat mitral valve regurgitation, then the valve can be repaired, but the patient leaflets experience stress leading to inadequate sealing and longer operation times
Solution Approach 1:
The device divides the sealing function into multiple segments: the coaption element provides the primary seal, while multiple paddles (typically 3-6) and barbed clasps work together to capture and secure the leaflets. This segmentation distributes the mechanical stress across multiple contact points rather than concentrating it at a single stitch or clip location, improving sealing reliability while enabling faster deployment through a catheter-based approach
2Reliability
If surgical stitching is used to repair the mitral valve, then the valve can be sealed, but the procedure is highly invasive and prone to complications
Solution Approach 1:
The coaption element serves as an intermediary component positioned between the mitral valve leaflets to create the seal, rather than directly stitching or clipping the leaflets themselves. This intermediate structure distributes forces and reduces direct stress on the delicate leaflet tissue. Additionally, the entire device is delivered through a catheter via the trans-septal approach, using the bloodstream as an intermediary pathway to reach the heart valve without requiring open chest surgery
Solution Approach 2:
The invention replaces the traditional mechanical surgical stitching system with a self-expanding frame structure that is deployed via catheter. The mechanical action transitions from manual suturing to controlled expansion of the frame against the leaflets, actuated by withdrawing the delivery catheter. This substitution enables the sealing function to be achieved through a minimally invasive percutaneous approach rather than open surgery
3Ease of operation
If catheter-delivered clips are used to clip the leaflets, then the procedure is less invasive, but the clips can only be used where leaflets overlap by 2mm or more, limiting applicability
Solution Approach 1:
The device incorporates barbed clasps on the paddles that can selectively engage with leaflet tissue at various locations, not limited to areas with 2mm overlap. The barbs provide localized gripping action that adapts to different leaflet geometries and overlap conditions, allowing the device to function effectively across a broader range of anatomical variations while maintaining the minimally invasive catheter-delivered approach
4Reliability
If multiple clips are placed on the commissures to treat regurgitation, then more extensive sealing can be achieved, but the operation time increases and blood flow is restricted
Solution Approach 1:
The device merges multiple functional elements into a single integrated structure: the coaption element, multiple paddles, and barbed clasps all work together in one deployment action. This consolidation achieves extensive sealing coverage equivalent to multiple separate clips but through a single catheter-delivered device, significantly reducing operation time and avoiding the need for multiple sequential interventions while maintaining blood flow
Data Source
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AI summary
An implantable prosthetic device includes a coaption portion, paddles, and clasps. The paddles are moveable from a closed position to an open position. The clasps are also moveable from an open position to a closed position. The implantable prosthetic device can be used to repair a naitive valve, such as a native mitral valve.