Mitral Valve Replacement Device Anchoring via Annulus Tabs
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Solution Overview
Problem
Current medical devices for treating mitral regurgitation are invasive and often ineffective, requiring open-heart surgery or endovascular clipping with complications such as difficulty in positioning, recurrence of regurgitation, and need for multiple clips, which do not fully address the need for a less invasive solution.
Innovation Solution
A mitral valve replacement device with an atrial flange and annulus support that secures to the native mitral annulus without barbs or hooks, featuring a novel leaflet structure with an umbrella-shaped configuration for efficient valvular control and flow, deployable through a catheter-based procedure, using biocompatible materials and anchoring features to prevent migration during cardiac cycles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If endovascular clipping is used to treat mitral regurgitation, then the procedure is less invasive than open-heart surgery, but positioning difficulty and recurrence of regurgitation occur
Solution Approach 1:
The device divides the anchoring function into multiple independent elements: an annulus support with multiple tabs that can engage the mitral annulus at different locations, and a leaflet support with multiple engagement points. This segmentation allows for more precise positioning and stable anchoring without requiring multiple clips or complex procedures.
Solution Approach 2:
The device creates a stable anchoring system where the tabs on the annulus support and the engagement points on the leaflet support work together at equivalent levels of force distribution. This equipotential anchoring prevents migration and ensures reliable positioning without concentrating stress at single critical points.
2Reliability
If multiple clips are used in endovascular clipping, then the effectiveness of treatment improves, but device complexity and procedural difficulty increase
Solution Approach 1:
The device merges the functions of multiple clips into a single integrated structure. The annulus support with multiple tabs and the leaflet support with multiple engagement points work together as one unified device, providing the anchoring and positioning functions that would otherwise require multiple separate clips.
Solution Approach 2:
The single device performs multiple functions: the annulus support anchors to the mitral annulus, the leaflet support engages the leaflets, and the connecting structure maintains proper spacing and orientation. This multi-functional design replaces what would otherwise require multiple specialized clips.
3Strength
If barbs or hooks are used to secure the device, then anchoring strength improves, but tissue damage and complication risk increase
Solution Approach 1:
The tabs on the annulus support and the engagement structures on the leaflet support are designed as flexible, thin structures that can deform elastically during engagement. This flexibility allows them to conform to the tissue surface and secure anchoring without requiring barbs or hooks that would pierce or damage the tissue.
Solution Approach 2:
The engagement surfaces are designed with curved, rounded geometries that distribute contact forces over larger areas. This curvature allows the tabs and engagement structures to maintain strong anchoring through surface contact rather than point contact, eliminating the need for penetrating barbs or hooks.
4Reliability
If open-heart surgery is performed, then complete valve replacement can be achieved, but patient risk and procedural invasiveness increase significantly
Solution Approach 1:
The device serves as an intermediary between the minimally invasive delivery approach and the need for secure valve anchoring. The expandable frame and engagement structures provide the necessary anchoring and positioning that would traditionally require open surgery, but are delivered through a catheter-based approach, thereby eliminating the need for sternotomy and cardiopulmonary bypass.
Data Source
AI summary
A mitral valve replacement device is adapted to be deployed at a mitral valve position in a human heart. The device has an atrial flange defining an atrial end of the device, a valve body defining a ventricular end of the device, and an annulus support that connects the atrial flange and the valve body, the annulus support including a ring of tabs extending radially therefrom and adapted to engage the native mitral annulus and/or the native leaflet(s) of the human heart. The atrial flange can be seated in the atrium above the native mitral valve annulus in a human heart, and the ring of tabs can engage the native mitral annulus in a manner where the atrial flange and tabs provide a clipping effect to secure the mitral valve replacement device at the native mitral valve position.