Sinus-Engaging Valve Fixation for Low-Force Aortic Implantation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing prosthetic valve implantation methods often require high radial forces that can damage native leaflets, lead to embolism, and result in leakage, particularly when treating aortic stenosis, and do not effectively utilize minimally-invasive approaches.
Innovation Solution
A collapsible aortic valve prosthesis with a distal and proximal fixation member that applies axial forces to sandwich the native valve, minimizing radial forces and reducing damage, allowing for minimally-invasive implantation without full leaflet opening, and utilizing self-expanding features for secure placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high radial forces are applied during valve implantation to secure fixation, then the valve is firmly anchored, but damage to native leaflets occurs, embolism risk increases, and leakage results
Solution Approach 1:
The fixation member is divided into multiple engagement arms (typically three) that independently engage with the aortic sinus. This segmentation distributes the anchoring force across multiple contact points rather than concentrating high radial force at a single location, thereby securing valve fixation while reducing damage to native leaflets and minimizing embolism risk.
Solution Approach 2:
The engagement arms are configured to engage the aortic sinus in an axial direction rather than purely radially. By extending distally into the aortic sinus and applying axial forces, the fixation member achieves secure anchoring through a different dimensional approach, reducing the harmful radial compression on native leaflets while maintaining reliable fixation.
2Reliability
If traditional implantation methods are used to ensure valve stability, then the valve is securely fixed, but minimally-invasive approaches cannot be effectively utilized
Solution Approach 1:
The fixation member is designed to be collapsible to a compressed configuration for delivery through minimally-invasive access routes, then expandable to an expanded configuration at the implantation site to engage the aortic sinus and provide stable fixation. This dynamic transformation enables both minimally-invasive implantation and reliable valve stability.
Solution Approach 2:
The collapsible fixation member can be nested within a delivery catheter in its compressed state, allowing it to be delivered through minimally-invasive access. Upon deployment, it expands from the nested configuration to its functional expanded configuration, achieving both ease of minimally-invasive operation and reliable valve stability.
3Manufacturing precision
If full leaflet opening is performed during implantation to ensure proper valve positioning, then accurate placement is achieved, but the risk of embolism and coronary occlusion increases
Solution Approach 1:
The engagement arms act as intermediary structures that provide tactile feedback and mechanical guidance during implantation. By engaging the aortic sinus and providing resistance, they serve as intermediaries that guide the valve to proper positioning without requiring full leaflet opening, thereby achieving accurate placement while minimizing the risk of embolism and coronary occlusion.
Solution Approach 2:
The fixation member's engagement arms self-align and engage with the aortic sinus through the natural anatomical landmarks, providing self-guidance during implantation. This self-service mechanism achieves accurate valve positioning without requiring aggressive manipulation or full leaflet opening, reducing the risk of embolism and coronary occlusion.
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
Reduces the risk of embolism and coronary occlusion by gentle engagement of native leaflets, minimizes leakage, and facilitates secure implantation with reduced damage, while maintaining effective valve function.
Implementation Method 1
each of the engagement arms is configured to engage a respective one of the aortic sinuses and, in combination, to apply, to tissue that defines the aortic sinuses, an axial force directed toward the left ventricle
Implementation Method 2
A collapsible aortic valve prosthesis with a distal and proximal fixation member... utilizing self-expanding features for secure placement
Data Source
AI summary
A method of delivering and deploying a valve prosthesis includes delivering the valve prosthesis disposed in a delivery catheter to a native valve, proximally retracting a delivery catheter tube of the delivery catheter such that three engagement arms of a support of the valve prosthesis are released from the delivery catheter tube and flare outwardly while an inflow frame portion of the support remains within a distal portion of the delivery catheter, and distally advancing the distal portion of the delivery catheter such that the inflow frame portion is released from the distal portion.