Self-Expanding Mitral Valve Frames with Shape-Memory Cuffs
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Solution Overview
Problem
Current transcatheter prosthetic heart valves face challenges such as leakage, poor fit, and complexity in anchoring, especially for the mitral valve, due to insufficient articulation and sealing within the native annulus, leading to issues like pulmonary edema and perivalvular leaking.
Innovation Solution
A prosthetic cardiovascular valve design featuring a self-expanding inner and outer frame with a flared cuff made of shape-memory materials like Nitinol, which provides a tight seal and conforms to the mitral annulus, minimizing leakage and accommodating anatomical irregularities through compliance and adjustable tethers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional open heart surgery is used for valve replacement, then the valve can be replaced with good structural support, but the procedure carries high morbidity and mortality risk due to extra-corporeal circulation
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a transcatheter delivery system that can be inserted through a catheter, eliminating the need for thoracotomy, heart-lung machine, and sternotomy, thereby reducing morbidity while maintaining valve replacement effectiveness
Solution Approach 2:
The patent uses a flexible fabric covering the wireframe structure that allows the prosthetic valve to conform to the irregular native mitral annulus geometry, improving sealing and reducing perivalvular leakage while maintaining structural integrity
2Reliability
If a prosthetic valve is inserted into the native mitral annulus, then valve replacement is achieved, but leakage occurs due to insufficient articulation and sealing within the annulus
Solution Approach 1:
The flexible fabric covering the wireframe conforms to the irregular native mitral annulus geometry, creating a seal that prevents perivalvular leakage while allowing the rigid wireframe to maintain its structural shape and support
Solution Approach 2:
The patent employs shape-memory materials that change their physical parameters (shape, stiffness) in response to temperature or stress changes during deployment and cardiac cycling, enabling the frame to articulate with the annulus and maintain sealing contact
3Strength
If a rigid wireframe structure is used for the prosthetic valve, then structural support is provided, but poor fit occurs within the irregular native mitral annulus
Solution Approach 1:
The flexible fabric covering allows the rigid wireframe to adapt to the irregular native mitral annulus geometry by deforming the fabric layer, maintaining both structural support from the wireframe and precise fit within the annulus
Solution Approach 2:
The wireframe is constructed from multiple diamond-shaped members that can articulate and adjust independently, allowing the overall structure to conform to the irregular annulus geometry while maintaining local structural support at each segment
4Object-generated harmful factors
If the prosthetic valve is designed to conform to the mitral annulus, then leakage is reduced, but device complexity increases due to compliance and articulation requirements
Solution Approach 1:
The flexible fabric covering provides the compliance and articulation needed to conform to the mitral annulus and reduce leakage, while the underlying wireframe maintains a relatively simple geometric structure that is easier to manufacture and deploy
Solution Approach 2:
The patent incorporates dynamic elements such as shape-memory materials and articulated diamond members that automatically adjust to annular motion during the cardiac cycle, providing compliance and sealing without requiring complex active control mechanisms
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The design effectively reduces leakage and improves fit by conforming to the mitral annulus, maintaining structural integrity under cardiac forces, and reducing pulmonary edema, while allowing for customization and compliance with the cardiac cycle.
Implementation Method 1
A prosthetic cardiovascular valve design featuring a self-expanding inner and outer frame with a flared cuff made of shape-memory materials like Nitinol
Implementation Method 2
provides a tight seal and conforms to the mitral annulus, minimizing leakage and accommodating anatomical irregularities through compliance
Data Source
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AI summary
A self-expanding wire frame for a pre-configured compressible transcatheter prosthetic cardiovascular valve, a combined inner frame / outer frame support structure for a prosthetic valve, and methods for deploying such a valve for treatment of a patient in need thereof, are disclosed.