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

VSEngineering 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

Engineering Contradiction:
Improvereflux preventionVSAvoidthrombosis
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #15Dynamics

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.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If existing valve designs are used, then reflux prevention is attempted, but the valve nest becomes immobile and stagnant, leading to thrombosis

Engineering Contradiction:
Improvereflux preventionVSAvoidvalve nest mobility
Core Design Contradiction:
ReliabilityVSStability of the object's composition

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.

Inventive Principle:
Principle #15Dynamics

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.

Inventive Principle:
Principle #25Self-service

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

Engineering Contradiction:
Improvereflux preventionVSAvoidflap mobility
Core Design Contradiction:
ReliabilityVSEase of operation

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.

Inventive Principle:
Principle #15Dynamics

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.

Inventive Principle:
Principle #35Parameter changes

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

Methodology Applied
Scientific EffectFluid flow force:

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

Methodology Applied
Scientific EffectFluid flow washing:

Data Source

PatentEP3145451B1Prosthetic valve for treating diseases causing reflux affecting the lower limbs
Publication Date: 2020.11.11 MALETI OSCAR
  • EP3145451B1 patent drawingFigure 1
  • EP3145451B1 patent drawingFigure 2
  • EP3145451B1 patent drawingFigure 3

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).