Stented Valve Fixation Element With Pivotable Clamp
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Solution Overview
Problem
Current minimally invasive techniques for replacing dysfunctional mitral or tricuspid heart valves face challenges due to the complex geometry of these valves, leading to insecure fixation and increased procedural risks.
Innovation Solution
A fixation element comprising a control rod with a pivotable clamp and actuator, allowing for secure anchoring of a stented valve to the native valve, utilizing a control rod with axial flexibility and a pivotable clamp that can be operated to securely fasten the valve, even in irregular geometries.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a minimally invasive catheter-based approach is used to replace a mitral or tricuspid valve, then the procedural risk and invasiveness are reduced, but the fixation security and reliability are compromised due to the complex irregular geometry of these valves
Solution Approach 1:
The clamp assembly is designed with pivotable arms that can dynamically adjust their position and orientation to conform to the irregular geometry of the mitral or tricuspid valve annulus. The arms can pivot relative to each other and to the delivery catheter, allowing the fixation element to adapt to the complex three-dimensional shape of the target site while maintaining secure engagement.
Solution Approach 2:
The fixation element utilizes shape memory alloy materials that can change their physical parameters (shape, rigidity) in response to temperature changes or mechanical activation. This allows the arms to be delivered in a constrained state and then transformed into an expanded, engagement-ready configuration at the target site, optimizing both delivery profile and fixation capability.
2Strength
If the clamp arms are made rigid to ensure stable fixation, then the fixation strength is improved, but the ability to accommodate irregular valve geometry is reduced
Solution Approach 1:
The clamp assembly is divided into multiple segmented arms that can independently pivot and adjust. Each arm can be positioned to match the local geometry of the valve annulus, while the segments work together to provide distributed fixation strength. This segmentation allows the structure to be both strong and adaptable to irregular shapes.
Solution Approach 2:
The arms are constructed using composite materials that combine rigid sections for structural strength with flexible or shape-memory sections for geometric adaptation. This composite construction allows the arms to maintain sufficient rigidity for secure fixation while incorporating elements that can flex or transform to accommodate the irregular contours of the mitral or tricuspid valve.
3Reliability
If multiple fixation points are used to improve security, then the fixation reliability is improved, but the device complexity and procedural difficulty increase
Solution Approach 1:
Multiple fixation arms are integrated into a single unified clamp assembly that is delivered through one catheter. The arms are mechanically linked through pivot points and common structural elements, allowing them to function as a coordinated unit rather than separate components. This merging reduces the number of separate delivery systems and control mechanisms needed while maintaining multiple fixation points for enhanced reliability.
4Strength
If the clamp is designed to fully enclose the stent for maximum security, then the fixation strength is improved, but the ease of deployment and operation is reduced
Solution Approach 1:
The clamp arms are pre-positioned in an open, non-engaging configuration during delivery, allowing the stent to be deployed first without obstruction. After stent deployment, the arms are then actuated to close around the stent and engage with the valve annulus. This preliminary positioning eliminates the need for complex coordinated movements during the critical deployment phase, simplifying the procedure while maintaining strong final fixation.
Data Source
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AI summary
The present invention relates to a stented valve, and can be used to repair and/or replace dysfunctionai heart valves. In particular, the present invention relates to a stented valve that can be used to repair and/or replace a dysfunctional mitral or tricuspid heart valve. According to the present invention, there is provided a coupling for a stented valve and a fixation element, the coupling comprising: a connector adapted to receive the fixation element, and a guide adapted to receive the stented valve; wherein the connector is reciprocally movable relative to the guide.