Partial-Sinus Valve Prosthesis for Blood Stagnation Control
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Solution Overview
Problem
Existing expandable-frame valve prostheses lack an artificial sinus or pocket space that simulates natural blood flow patterns, leading to stagnation and thrombosis, which compromises the functionality of implanted valves by limiting the motion or responsiveness of moveable portions.
Innovation Solution
A radially-expandable valve prosthesis with a laterally asymmetric partial sinus portion in the interior lumen, featuring a monocuspid valve leaflet that moves between open and closed configurations to regulate fluid flow and prevent stagnation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If expandable-frame valve prostheses are designed with a generally cylindrical shape, then the device structure is simple and easy to manufacture, but the device lacks an artificial sinus or pocket space that is sufficient for simulating natural blood flow patterns, leading to blood stagnation and thrombosis
Solution Approach 1:
The frame is designed with an asymmetric cross-section featuring a sinus portion that extends into the lumen, creating a non-cylindrical geometry. This asymmetric design simulates natural blood flow patterns by creating a pocket space that promotes vortex formation and prevents stagnation, while maintaining manufacturing feasibility through controlled shaping of the frame structure.
Solution Approach 2:
The frame transitions from a simple cylindrical shape to a three-dimensional structure with a sinus portion extending into the lumen. This dimensional modification creates a pocket space that adds functional complexity for blood flow simulation while maintaining overall structural simplicity for manufacturing.
2Device complexity
If the frame is designed without a sinus portion, then the device complexity is reduced, but blood stagnation occurs around the valve leading to thrombosis and compromised valve functionality
Solution Approach 1:
An asymmetric sinus portion is integrated into the frame structure, creating a pocket space that promotes natural blood flow patterns through vortex formation. This design increase in complexity is minimal and directly addresses the harmful effect of blood stagnation and thrombosis risk.
Solution Approach 2:
The sinus portion creates a pocket space that initially appears to increase complexity, but this structural modification converts the harmful stagnation zone into a beneficial flow pattern generator. The pocket space promotes vortex formation that actively prevents thrombosis, transforming a potential harm into a protective mechanism.
3Ease of manufacture
If the valve prosthesis lacks a partial sinus portion, then the manufacturing process is simpler, but post-implantation thrombosis and platelet deposition may occlude the conduit or compromise valve functionality
Solution Approach 1:
The frame incorporates an asymmetric sinus portion that extends into the lumen, creating a pocket space designed to promote natural blood flow patterns. This design modification maintains manufacturing simplicity while significantly improving long-term reliability by preventing thrombosis and platelet deposition through enhanced flow dynamics.
Solution Approach 2:
The sinus portion adds a three-dimensional pocket space to the frame structure, creating a functional dimension that promotes vortex formation and prevents blood stagnation. This dimensional enhancement maintains manufacturing feasibility while ensuring long-term valve functionality by preventing thrombotic occlusion.
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 design enhances blood flushing around the valve, reducing thrombosis risk and maintaining valve functionality by simulating natural blood flow patterns, thereby improving the effectiveness of venous valve function.
Implementation Method 1
the pockets formed between the leaflets and the walls of the sinus create vortices of flowing blood that help flush the pocket and prevent blood from stagnating
Data Source
Figure 1
Figure 2
Figure 3A~3B
AI summary
The disclosure relates to an expandable valve prosthesis for regulating flow through a body vessel. The prosthesis comprises a frame (200) configured to form a laterally asymmetric partial sinus and a valve member (250).