Monocusp Prosthetic Valve Flap Dynamics for Venous Reflux
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Solution Overview
Problem
Current prosthetic valves for treating venous reflux in the lower limbs often result in thrombosis and immobility due to inadequate physiological expansion of the venous nest, leading to ineffective reflux prevention and thrombosis, as existing designs fail to replicate the natural valve's mobility and washing mechanism.
Innovation Solution
A monocusp valve designed with a stent and a biocompatible flap, positioned across a large tributary vein to ensure continuous washing of the valve nest, utilizing opposite forces to maintain the flap in a semi-open position, preventing reflux and thrombosis while allowing normal blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic valve is implanted in the venous system to prevent reflux, then reflux prevention is improved, but thrombosis and immobility occur due to inadequate physiological expansion of the valve nest
Solution Approach 1:
The patent applies the dynamics principle by designing a prosthetic valve with a movable flap that can dynamically open and close based on blood flow conditions. The flap is connected to the stent via a hinge mechanism, allowing it to respond to hemodynamic forces. This dynamic structure enables the valve to maintain physiological expansion of the valve nest while preventing reflux, thereby avoiding thrombosis that occurs with static valve designs.
Solution Approach 2:
The patent utilizes parameter changes by modifying the physical and geometric parameters of the valve structure. The stent is designed with specific mesh dimensions and the flap has optimized dimensions relative to the valve nest. The hinge mechanism allows the flap to change its position and orientation based on blood flow pressure differential. These parameter optimizations ensure adequate physiological expansion of the valve nest while maintaining effective reflux prevention.
2Reliability
If existing valve designs are used, then reflux prevention is attempted, but the valve nest becomes immobile and stagnant, leading to thrombosis
Solution Approach 1:
The patent implements dynamics by creating a movable flap structure that continuously moves with blood flow. The hinge connection allows the flap to rotate and position itself according to hemodynamic forces, maintaining constant motion within the valve nest. This dynamic movement prevents blood stagnation and promotes continuous washing of the valve nest, eliminating the immobility problem of fixed valve designs.
Solution Approach 2:
The patent applies self-service through the automatic response of the flap to blood flow conditions. The flap is designed to automatically open when blood flow pressure exceeds a certain threshold and close when pressure decreases, without requiring external control mechanisms. This self-regulating behavior maintains valve nest mobility and washing action while effectively preventing reflux, making the system self-sustaining and adaptive to changing hemodynamic conditions.
3Reliability
If the valve flap is positioned to prevent reflux, then reflux prevention is improved, but the flap may become fixed and lose mobility, causing thrombosis
Solution Approach 1:
The patent implements dynamics through the hinge mechanism that connects the flap to the stent. This hinge allows the flap to rotate freely within a certain range, maintaining mobility while positioned to prevent reflux. The dynamic range of motion is carefully designed to ensure the flap remains mobile enough to prevent thrombosis while maintaining sufficient positioning to block reflux flow.
Solution Approach 2:
The patent utilizes parameter changes by optimizing the hinge flexibility and flap dimensions relative to the valve nest. The hinge is designed with specific mechanical properties that allow controlled movement, and the flap dimensions are optimized to maintain adequate sealing position while preserving mobility. These parameter optimizations ensure the flap can effectively prevent reflux while remaining mobile enough to avoid thrombosis.
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 solution effectively prevents reflux and thrombosis by maintaining the valve nest's mobility and cleanliness, ensuring physiological blood flow and reducing the risk of complications associated with existing valve designs.
Implementation Method 1
utilizing opposite forces to maintain the flap in a semi-open position
Implementation Method 2
The valve nest 4, defined by the flap 2, is continuously washed by the blood flow coming from the collateral vein 200
Data Source
Figure 1
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AI summary
Monocusp prosthetic valve (1) comprising the flap (2) made of biocompatible material, and the stent (3) made of biocompatible or bio-absorbable material, said stent (3) having meshes (3') defining holes (3") with profile represented by any closed curve or polygonal shape, said prosthetic valve (1) being characterized in that the flap (2) is sewn on said stent (3) by means of pairs (6) of suture points that are longitudinally extended along opposite surfaces of said flap (2).