Shape-Memory Anchor Hook for Side-Delivered Heart Valve Anchoring
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Solution Overview
Problem
Existing transcatheter prosthetic heart valves face challenges in delivery and deployment due to their limited expanded diameter, which is constrained by the internal diameter of the delivery catheter, making it difficult to achieve effective anchoring while maintaining a small compressed size for transcatheter delivery.
Innovation Solution
The development of an anchor hook system with an elongated shaft portion, a hook portion, anchoring tabs or barbs, and a tether system, made from shape memory material, which can be heat-set into an open configuration for expansion and adjusted to a closed configuration for compression, allowing for secure subannular anchoring of transcatheter heart valves.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Volume of moving object
If the valve is compressed to a small size for transcatheter delivery, then the delivery catheter size can be minimized, but the expanded diameter of the valve is limited by the internal diameter of the delivery catheter
Solution Approach 1:
The valve is divided into multiple segments or cells that can be independently compressed and expanded. The annular support frame is constructed from multiple compressible wire cells that can be folded into a compact configuration for delivery and then expanded to a larger diameter at the deployment site, overcoming the limitation of traditional monolithic valve designs.
Solution Approach 2:
The valve employs a dynamic structure that transitions between compressed and expanded states. The wire cells can be dynamically folded and unfolded, allowing the valve to adapt its size according to the delivery requirements. This dynamic capability enables the valve to achieve a large expanded diameter while maintaining a small compressed profile for catheter delivery.
2Reliability
If the valve expanded diameter is increased to achieve effective anchoring, then better anchoring performance is achieved, but the delivery catheter internal diameter must be larger
Solution Approach 1:
The annular support frame is segmented into multiple wire cells that can be compressed into a compact configuration for delivery through small catheters. These segmented cells can then be expanded at the deployment site to provide sufficient anchoring diameter, thus achieving reliable anchoring without requiring a large delivery catheter.
Solution Approach 2:
The valve structure employs a nested configuration where the wire cells are folded within each other to create a compact delivery profile. This nesting allows the valve to be delivered through a small catheter and then expanded at the target site, effectively separating the delivery size from the operational size.
3Ease of operation
If traditional valve compression methods are used, then the valve can be delivered through catheters, but the competing interest of minimizing delivery catheter size presents challenges to increasing the expanded diameter
Solution Approach 1:
The valve structure is designed to be dynamically reconfigurable, transitioning from a compressed delivery configuration to an expanded operational configuration. This dynamic capability allows the valve to overcome the size limitation imposed by the delivery catheter, achieving both ease of delivery and sufficient expanded diameter for effective deployment.
Solution Approach 2:
The valve employs a three-dimensional wire cell structure that can be folded and unfolded in multiple dimensions. This dimensional flexibility allows the valve to achieve a compact profile for delivery and then expand in three dimensions at the target site, separating the delivery dimension from the operational dimension.
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 anchor hook system enables secure anchoring of transcatheter heart valves by expanding the anchoring tabs and hook portion to capture native tissue, while the compression mechanism allows for retrieval and redeployment, facilitating efficient delivery and deployment while maintaining a small profile for transcatheter access.
Implementation Method 1
the anchor hook made from shape memory material and the anchor hook heat-set into an open or expanded configuration
Data Source
AI summary
The invention relates to an anchor hook and methods of using the same for subannular anchoring of a transcatheter heart valve replacement, and in particular for an orthogonally delivered (side-delivered) transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the mitral or tricuspid valve from the inferior vena cava or superior vena cava, or trans-septally to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring a delivery catheter to bend 90 degrees during deployment.