Sinus-Engaging Valve Fixation With Axial Leaflet Protection
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Solution Overview
Problem
Existing prosthetic valve implantation methods often require high radial forces against the native valve, risking damage to the leaflets and increased risk of embolism, and do not effectively prevent leakage around the prosthetic valve.
Innovation Solution
A self-expanding aortic valve prosthesis with collapsible inner and outer fixation members that apply axial forces to sandwich the native valve from both sides, minimizing radial force and reducing the need for suturing, while engaging with the aortic sinuses for secure fixation without fully opening the native leaflets.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If high radial forces are applied against the native valve for secure fixation, then the prosthetic valve achieves stable positioning, but the native leaflets are damaged and the risk of embolism increases
Solution Approach 1:
The patent transitions from radial fixation (applying force perpendicular to the valve axis) to axial fixation (applying force parallel to the valve axis). The engagement arms are configured to engage the aortic sinuses and apply axial forces that sandwich the native valve complex, thereby achieving secure fixation without damaging the native leaflets through radial compression.
Solution Approach 2:
The distal fixation member is segmented into multiple engagement arms (typically three) that are distributed around the valve axis. Each engagement arm independently engages with the aortic sinuses, allowing the fixation force to be distributed across multiple contact points rather than concentrated at a single radial point, reducing localized damage to the native valve structure.
2Reliability
If high radial forces are applied against the native valve for secure fixation, then the prosthetic valve achieves stable positioning, but the risk of embolism and coronary occlusion increases
Solution Approach 1:
The patent transitions from radial fixation to axial fixation, applying forces along the longitudinal axis of the valve rather than radially outward. This dimensional change allows the engagement arms to sandwich the native valve complex between the distal and proximal fixation members, achieving stable positioning without the high radial forces that cause embolism and coronary occlusion.
3Ease of operation
If the native leaflets are fully opened for prosthesis insertion, then the prosthetic valve can be implanted, but the risk of embolism and coronary occlusion increases
Solution Approach 1:
The distal fixation member is segmented into multiple engagement arms that can be independently configured to engage the aortic sinuses. This segmentation allows the prosthesis to be deployed without fully opening the native leaflets, as the engagement arms can access and engage the sinuses through the available space, reducing the risk of embolism while maintaining implantation feasibility.
4Reliability
If axial forces are applied to sandwich the native valve from both sides, then secure fixation is achieved with minimal radial force, but the device complexity increases
Solution Approach 1:
The engagement arms serve multiple functions: they provide structural support for the distal fixation member, engage with the aortic sinuses to provide axial fixation, and distribute forces across multiple contact points. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity while achieving secure axial fixation.
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 prosthesis reduces the risk of embolism and coronary occlusion by gentle engagement with native leaflets, maintains secure fixation without damaging the native valve, and minimizes leakage, facilitating minimally invasive implantation with reduced radial force application.
Implementation Method 1
A self-expanding aortic valve prosthesis with collapsible inner and outer fixation members
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.