Spiral Flow Inducing Stent for AVF Neointimal Hyperplasia

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Solution Overview

Problem

Arteriovenous fistulas (AVFs) used for hemodialysis often experience neointimal hyperplasia due to turbulent blood flow, leading to stenosis and potential failure, as the venous tissue responds abnormally to increased flow rates and pressure drops, which existing technologies have not effectively addressed.

Innovation Solution

A spiral flow inducing stent with helically shaped flow diverters, integrated with proximal and distal stent regions, is designed to promote laminar, spiral blood flow by cutting and bending sheet metal from a cannula to create a helical flow surface, which is then implanted near the AVF to potentially prevent or slow neointimal hyperplasia.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If an arteriovenous fistula is created to achieve high blood flow rates for hemodialysis, then the blood flow volume increases, but turbulent flow is generated causing neointimalhyperplasia and stenosis

Engineering Contradiction:
Improveblood flow rateVSAvoidfistula patency
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent applies curvature by forming the stent into a spiral configuration with helical struts that follow a curved path along the longitudinal axis. This spiral geometry is designed to induce rotational flow patterns in the blood, transforming the straight cylindrical stent into a structure that generates beneficial flow dynamics to reduce turbulence and prevent neointimalhyperplasia while maintaining high flow rates

Inventive Principle:
Principle #14Spheroidality (Curvature)

2Strength

If traditional straight stents are used to support the fistula, then structural support is provided, but turbulent flow patterns persist causing continued tissue proliferation

Engineering Contradiction:
Improvestent structural supportVSAvoidturbulent flow
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent transforms the traditional straight cylindrical stent into a spiral configuration where the struts follow a helical path. This curvature modification maintains the structural support function while fundamentally changing the flow dynamics from turbulent to rotational laminar flow, thereby eliminating the harmful turbulent flow patterns that cause tissue proliferation

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

The patent changes the geometric parameters of the stent from a straight configuration to a spiral configuration with specific helical angles and pitch. This parameter change transforms the flow regime from turbulent to rotational laminar flow while maintaining adequate structural support, thereby resolving the contradiction between structural integrity and flow pattern

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 stent induces spiral blood flow, reducing the progression of neointimal hyperplasia and maintaining healthy vascular function by mimicking native arterial blood flow patterns, thus extending the lifespan and effectiveness of AVFs.

Implementation Method 1

the native state of arterial blood flow may exhibit circumferentially oriented velocity components such that the blood flow is helical or spiral in nature

Methodology Applied
Scientific EffectSpiral flow: Vortex Ring

Implementation Method 2

The abnormal flow through an AVF appears to be generally turbulent rather than laminar

Methodology Applied
Scientific EffectTurbulent flow: Turbulence

Data Source

PatentUS10321984B2Spiral flow inducing stent and canula cut method of making same
Publication Date: 2019.06.18 COOK MEDICAL TECHNOLOGIES LLC
  • US10321984B2 patent drawing
  • US10321984B2 patent drawing
  • US10321984B2 patent drawing

AI summary

A cannula cut spiral flow inducing stent includes a plurality of spiral inducing flow diverters that each include a piece of sheet metal with a helically shaped flow surface. A proximal stent region, which includes a plurality of first struts, is joined to a proximal end of each of the spiral inducing flow diverters. A distal stent region, which includes a plurality of second struts, is joined to a distal end of each of the spiral inducing flow diverters. All of the first struts and all of the second struts share a cannula thickness, but the shaped pieces of sheet metal may have a lesser thickness.