Prosthetic Leaflet Device for Mitral Valve Repair
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Solution Overview
Problem
Current methods for repairing mitral valve regurgitation are invasive, painful, and have high morbidity, with durability issues and dependence on surgical skill, and lack effective, less invasive devices for treating dysfunctional heart valves.
Innovation Solution
A heart valve repair device featuring an atrial-fixation member with an expandable mesh and a baffle that extends radially inward to approximate a closed position of the native leaflet, providing a prosthetic coaptation surface and immobilizing functionally deficient leaflets, while allowing mobile leaflet segments, and utilizing frictional elements and biocompatible materials for secure fixation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional surgical approaches (open thoracotomy) are used for valve replacement, then complete valve replacement can be achieved, but the procedure becomes highly invasive with significant morbidity and long recovery periods
Solution Approach 1:
The patent uses a delivery catheter as an intermediary device to transport the collapsible valve prosthesis through the body to the target valve site. This allows the valve to be implanted percutaneously or through small incisions rather than requiring open thoracotomy, significantly reducing invasiveness while maintaining replacement effectiveness
Solution Approach 2:
The valve prosthesis is designed in a collapsible configuration that can be nested within the delivery catheter. This nesting allows the valve to be compressed to a small size for delivery through minimally invasive access routes, then expanded at the target site to achieve full functional size
2Stability of the object's composition
If annular or peri-annular rings are implanted for annulus cinching, then annular support can be provided, but the device complexity increases and proper sizing becomes critical
Solution Approach 1:
The valve prosthesis framework serves multiple functions simultaneously: it provides the valve leaflets for regurgitation prevention, acts as an annular support structure through its circumferential framework, and can be adjusted to accommodate different annulus sizes. This multi-functionality eliminates the need for separate annular rings while providing comparable support
Solution Approach 2:
The valve prosthesis features an adjustable framework that can be expanded or compressed to match the patient's specific annulus dimensions. This dynamic adjustability allows proper sizing without requiring multiple pre-fabricated size options or complex sizing procedures
3Reliability
If the mitral annulus is cinched or resected for repair, then regurgitation can be reduced, but the procedure becomes highly dependent on surgical skill with poorly placed sutures affecting success
Solution Approach 1:
The valve prosthesis is designed to be self-aligning and self-adjusting once deployed. The framework automatically conforms to the annular geometry, and the leaflets self-position to achieve proper coaptation. This eliminates the need for skill-dependent suture placement while ensuring consistent regurgitation prevention
4Device complexity
If radial support is not provided to the mitral annulus, then the device structure remains simple, but significant radial forces could lead to collapse of the inferior portion of the aortic tract
Solution Approach 1:
The valve prosthesis framework serves dual purposes: it provides the valve function and simultaneously acts as a radial support structure for the mitral annulus. The circumferential framework distributes radial forces evenly, preventing localized collapse of the aortic tract while maintaining overall structural simplicity
Data Source
AI summary
A heart valve repair device, comprising an atrial-fixation member having an expandable mesh configured to have oval or circular shape in a deployed configuration, the atrial-fixation member defining a central lumen; and a baffle extending from a portion of the atrial-fixation member, the baffle having an anterior portion with a smooth, atraumatic surface configured to coapt with at least a portion of one or more native leaflets of a native heart valve, a posterior portion configured to engage and displace at least a portion of another native leaflet of the native heart valve, wherein the baffle extends radially inward from the atrial-fixation member into the central lumen to approximate a closed position of the displaced native leaflet.