Collapsible Venous Valve Scaffold Preventing Retrograde Flow
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Solution Overview
Problem
Current venous valve prostheses face challenges such as thrombus formation, non-physiologic flow conditions, and material compatibility issues, particularly in the low-pressure venous system of the lower extremities, leading to inefficiencies and complications like blood pooling and varicose veins in patients with venous insufficiency.
Innovation Solution
A percutaneously placeable one-way venous valve prosthesis with a frustoconical coil-shaped scaffold and a backflow barrier, made from biocompatible materials, that alternates between open and closed configurations to mimic natural venous valve function, preventing retrograde blood flow and minimizing thrombosis risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional venous valve prostheses are used, then valve replacement is achieved, but thrombus formation and non-physiologic flow conditions occur
Solution Approach 1:
The valve prosthesis employs a dynamic collapsible scaffold that transitions between expanded and collapsed states based on blood flow direction. The scaffold collapses when retrograde flow occurs, allowing the backflow barrier to seal against the collapsed structure and prevent harmful backflow, thereby eliminating thrombus formation risks associated with static conventional valves
Solution Approach 2:
The backflow barrier is constructed as a flexible membrane that can deform and seal against the collapsed scaffold. This flexible barrier responds to pressure differentials and flow direction, creating a seal that prevents retrograde blood flow while maintaining compatibility with the low-pressure venous system, thus avoiding thrombus formation
2Reliability
If conventional venous valve prostheses are used, then valve replacement is achieved, but material compatibility issues arise in the low-pressure venous system
Solution Approach 1:
The valve prosthesis is designed with parameters optimized for the low-pressure venous system. The collapsible scaffold and flexible barrier are configured to respond appropriately to the low pressure differentials in veins, using material properties and geometric parameters that ensure compatibility with venous flow conditions, thereby eliminating material compatibility issues
3Reliability
If a collapsible scaffold is used, then backflow prevention is improved, but device complexity increases
Solution Approach 1:
The valve prosthesis merges the scaffold and backflow barrier into a single integrated structure. The barrier is attached to the scaffold such that they function as one unit, where the scaffold's collapse automatically activates the barrier's sealing action. This integration simplifies the overall device compared to separate components while maintaining effective backflow prevention
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 prosthesis effectively restores normal venous circulation by allowing antegrade blood flow while preventing backflow, reducing the risk of thrombosis and blood pooling, thus addressing venous insufficiency and related complications like varicose veins and deep vein thrombosis.
Implementation Method 1
The body portion is operable to alternate between an open configuration wherein the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween, and a closed configuration wherein the consecutive windings of the valve scaffold are collapsed such that the valve scaffold has a flat profile
Data Source
AI summary
A valve prosthesis for percutaneous placement within a vein is disclosed that includes a valve scaffold and a backflow barrier. The valve scaffold is of a shape memory or resilient material and the backflow barrier is a flap of flexible material attached to the valve scaffold. The valve prosthesis is operable to alternate between open and closed configurations in response to changes in retrograde blood flow pressure. In the open configuration, the valve scaffold has a frustoconical coil shape of consecutive windings with open spaces therebetween and the backflow barrier allows antegrade blood flow through the open spaces. In the closed configuration, the consecutive windings of the valve scaffold are collapsed such that the valve scaffold has a substantially flat profile and the backflow barrier covers the opens spaces of the flattened valve scaffold to prevent retrograde blood flow from leaking there through.