Sinusoidal Wire Commissure Posts for Flexible Heart Valve Deployment
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Solution Overview
Problem
Conventional stented bioprosthetic heart valves with rigid commissure posts face issues such as binding, overlapping, and failure to accommodate curved aortic profiles, leading to leaking, improper support, and trauma during delivery and deployment, due to their lack of flexibility and inability to fully expand radially.
Innovation Solution
The development of bioprosthetic heart valves with commissure posts formed from single or double wires featuring a sinusoidal wave pattern along their longitudinal axis, which increases bending flexibility by adjusting frequency, amplitude, and wavelength, allowing for complete radial expansion and deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If rigid commissure posts are used to provide structural support, then the valve maintains stability and proper positioning, but the valve cannot accommodate curved aortic profiles and experiences binding/overlapping during delivery
Solution Approach 1:
The commissure posts are constructed from wire segments configured in a sinusoidal or undulating pattern, creating a flexible structure that can bend and conform to curved aortic profiles while maintaining structural support. The sinusoidal configuration allows the posts to flex during delivery and deployment without binding or overlapping.
Solution Approach 2:
The commissure posts transition from a compressed state during delivery to an expanded functional state after deployment. The sinusoidal wire configuration enables dynamic adaptation during the delivery-deployment process, allowing the posts to bend during threading through vasculature and then stabilize in their functional position after expansion.
2Stability of the object's composition
If rigid commissure posts are used to maintain valve structure, then the valve provides proper support, but the inflow and outflow rings cannot fully radially expand leading to leaking and improper seating
Solution Approach 1:
The sinusoidal wire configuration of the commissure posts creates a flexible structure that allows the inflow and outflow rings to fully radially expand during deployment. The flexibility enables complete expansion without the binding and overlapping that would occur with rigid posts, ensuring proper seating and preventing leaking.
3Ease of operation
If the delivery mechanism is threaded through bent vasculature, then minimally invasive delivery is achieved, but the wire segments overlap on the inside radius of bends and create gaps on the outside radius
Solution Approach 1:
The sinusoidal wire configuration enables the commissure posts to dynamically adapt during threading through bent vasculature. The flexible structure allows the posts to bend without causing the wire segments to overlap on the inside radius or create excessive gaps on the outside radius, maintaining proper geometry during delivery.
Solution Approach 2:
The sinusoidal or undulating pattern of the wire segments changes the geometric parameters of the commissure posts, creating a configuration that accommodates bending during delivery. This parameter change in the wire configuration allows the structure to flex during navigation through curved vasculature while maintaining proper segment spacing.
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 flexible commissure posts ensure precise placement, minimize binding and overlapping, and provide a more open path for blood flow, ensuring proper seating and reducing the risk of trauma and leakage by allowing full radial expansion and deployment of the inflow and outflow rings.
Implementation Method 1
commissure posts formed from single or double wires featuring a sinusoidal wave pattern along their longitudinal axis, which increases bending flexibility
Data Source
Figure 1A~2
Figure 3A
Figure 3B
AI summary
A cylindrical anchoring structure for supporting a tissue heart valve is disclosed. The cylindrical anchoring structure defines a central longitudinal axis and includes an inflow ring having at least one sinusoidal-shaped wire with a plurality of peaks and troughs and an outflow ring having at least one sinusoidal-shaped wire with a plurality of peaks and troughs. A flexible commissure post having a longitudinal axis connects the inflow ring and the outflow ring. The flexible commissure post has a bending flexibility along a plane defined by a surface containing all straight lines connecting any point on the central longitudinal axis of the cylindrical anchoring structure and any point on the longitudinal axis of the flexible commissure post.