Expandable Heart Valve Segmented Frame Anchors
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Solution Overview
Problem
Developing replacement heart valves that can be compacted for delivery and controllably expanded for precise placement in minimally invasive procedures has proven to be challenging, particularly in ensuring effective one-way blood flow and secure engagement with the native valve annulus.
Innovation Solution
A replacement heart valve design featuring an expandable frame with upstream and downstream portions, a transition portion, and anchors that radially expand to securely engage the native valve annulus, allowing for controlled expansion and contraction, and a valve body with leaflets that open to allow flow in one direction and close in the opposite direction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the valve is designed to be compacted for delivery through minimally invasive procedures, then the delivery trauma to the patient is reduced, but the control and precision of expansion and placement becomes more difficult
Solution Approach 1:
The frame is divided into multiple expandable segments or cells that can be independently controlled during expansion. This segmentation allows precise control over the expansion process, enabling the valve to be deployed segment by segment with controlled radial force application, thereby maintaining both minimally invasive delivery and precise placement capability.
Solution Approach 2:
The frame incorporates dynamic expansion mechanisms that allow controlled radial expansion from a compacted state. The expandable structure enables progressive expansion with controlled force distribution, transforming the valve from a delivery configuration to an operational configuration while maintaining precision through controlled dynamic deployment.
2Reliability
If the valve body diameter is increased at the downstream end to ensure proper leaflet positioning and blood flow direction, then the one-way blood flow function is improved, but the overall valve size and complexity increases
Solution Approach 1:
The valve body is designed with asymmetric diameter distribution, being smaller at the upstream end and larger at the downstream end. This asymmetric geometry naturally guides blood flow in the desired direction while maintaining functional effectiveness. The asymmetric design achieves proper leaflet positioning and one-way flow function without requiring complex additional structures.
Solution Approach 2:
The valve body incorporates curved surfaces and rounded transitions between different diameter sections. These curved geometries facilitate smooth blood flow transitions and proper leaflet sealing while maintaining a streamlined profile. The curvature helps achieve effective one-way flow function with more elegant, less complex geometry.
3Reliability
If anchors are extended to engage the native valve annulus securely, then the engagement reliability is improved, but the radial force required for deployment and the overall device length increases
Solution Approach 1:
The anchor system is segmented into multiple discrete anchor points distributed around the valve circumference. Each anchor can be independently deployed and engaged with the native annulus. This segmentation allows secure engagement through distributed contact points while reducing the radial force required at any single location, as the force is distributed across multiple engagement points.
Solution Approach 2:
The anchors are pre-positioned on the frame in a compacted state, ready for deployment. During installation, the anchors are deployed in a controlled sequence that engages with the native valve annulus before full expansion occurs. This preliminary anchoring action secures the valve position while minimizing the radial force required during subsequent expansion, as the anchors provide initial stabilization.
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
A replacement heart valve can have an expandable frame configured to engage a native valve annulus. A valve body can be mounted onto the expandable frame to provide functionality similar to a natural valve. The valve body has an upstream end and a downstream end, and a diameter at the downstream end is greater than a diameter at the upstream end.