PVA Hydrogel Prosthetic Venous Valve Design

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Solution Overview

Problem

Current prosthetic venous valves for treating chronic venous insufficiency (CVI) face challenges such as high thrombogenicity, biocompatibility issues, incorrect sizing, and functionality problems, including radial buckling and leaflet prolapse, which hinder effective minimally invasive treatment options for deep venous reflux.

Innovation Solution

A novel prosthetic venous valve design featuring a cylindrical base with thin walls, elongated leaflets, and unique geometry to prevent prolapse, made from biocompatible polyvinyl alcohol (PVA) hydrogel with specific structural features like slits and a stent for expansion, which reduces shear rates and enhances flexibility and strength, ensuring low thrombogenicity and correct sizing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a prosthetic venous valve is implanted to treat deep venous reflux, then venous reflux is reduced, but thrombogenicity increases and biocompatibility deteriorates

Engineering Contradiction:

Improvereflux reduction effectivenessVSAvoidthrombogenicity

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material parameters by using PVA hydrogel with specific porosity (50-90% pore volume) and mechanical properties (elastic modulus 0.1-10 MPa). These parameter changes make the valve material more thromboresistant while maintaining reflux prevention functionality, directly addressing the contradiction between effectiveness and thrombogenicity

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent employs composite material structure combining PVA hydrogel with reinforcing fibers or a mesh framework. This composite approach provides both the biocompatibility and thromboresistance of hydrogel and the structural strength needed for valve function, resolving the contradiction between material softness and structural integrity

Inventive Principle:

Principle #40Composite materials

2Stability of the object's composition

If a prosthetic venous valve with radial support structure is used to prevent buckling, then structural stability improves, but outflow resistance increases to obstruction levels

Engineering Contradiction:

Improvestructural stabilityVSAvoidoutflow resistance

Core Design Contradiction:

Stability of the object's compositionVSObject-generated harmful factors

Solution Approach 1:

The patent uses a flexible PVA hydrogel shell structure that provides radial support through material elasticity rather than rigid struts. The hydrogel's viscoelastic properties allow it to maintain valve shape and prevent buckling during cycling while remaining flexible enough to minimize flow resistance, directly resolving the contradiction between stability and outflow resistance

Inventive Principle:

Principle #30Flexible shells and thin films

3Ease of operation

If a minimally invasive transcatheter approach is used for valve implantation, then patient trauma is reduced, but valve sizing precision and placement accuracy deteriorate

Engineering Contradiction:

Improveimplantation invasivenessVSAvoidvalve sizing and placement accuracy

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The patent employs a dynamic delivery system where the compressed valve is delivered through a catheter and then expanded in situ using balloon expansion or self-expansion mechanisms. This dynamic approach allows the valve to be delivered minimally invasively while achieving precise sizing and placement through controlled expansion at the target site, resolving the contradiction between ease of implantation and placement precision

Inventive Principle:

Principle #15Dynamics

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 valve effectively reduces reflux by over 99.4% while maintaining low outflow resistance, remaining competent under various pressures and cycles, and is designed for percutaneous delivery, demonstrating improved biocompatibility and reduced thrombosis risk.

Implementation Method 1

made from biocompatible polyvinyl alcohol (PVA) hydrogel with specific structural features like slits and a stent for expansion, which reduces shear rates

Methodology Applied

Scientific EffectViscoelasticity: Viscoelasticity

Data Source

PatentUS10201425B2Implantable open vein valve

Publication Date: 2019.02.12 GEORGIA TECH RES CORP

AI summary

The invention provides prosthetic venous valves, and method of use thereof, for the effective treatment of individuals with venous reflux in chronic venous insufficiency (CVI). The development of such prosthetic venous valves in the areas of valve design, design specifications, verification and/or validation testing, computational analysis, valve placement and clinician guidance and procedure are provided. Manufacturing the prosthetic venous valves of the invention is also provided.