Curved Expandable Medical Device for Stent Alignment and Flow Control

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Solution Overview

Problem

Current medical devices fail to effectively prevent thrombosis, atherosclerosis, and intimal hyperplasia in blood vessels due to inadequate flow patterns, and struggle with stent alignment and deployment in curved geometries.

Innovation Solution

A medical device featuring an expandable element that changes configuration from a collapsed, straight shape to an expanded, three-dimensionally curved shape, inducing a swirling blood flow and incorporating alignment markers for precise stent alignment, which can be used to exert force on the blood vessel wall to recreate or reinforce a curved stent shape.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If an expandable element is used to exert force on the blood vessel wall to create a curved stent shape, then stent alignment and deployment in curved geometries is improved, but device complexity increases due to the need for alignment markers and three-dimensional configuration control

Engineering Contradiction:
Improvestent alignment in curved geometriesVSAvoiddevice structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The expandable element is designed with a three-dimensionally curved configuration in its expanded state, featuring a longitudinal axis that curves in three-dimensional space. This curved geometry enables the device to conform to and deploy stents in curved blood vessel segments, directly addressing the adaptability requirement while using the curvature itself as the functional feature rather than adding complex mechanical components

Inventive Principle:
Principle #14Spheroidality (Curvature)

Solution Approach 2:

Alignment markers are incorporated on the expandable element to facilitate precise positioning and orientation during deployment. These markers enable visualization and alignment control without adding mechanical complexity, allowing operators to accurately position the curved expandable element in the desired three-dimensional configuration within the blood vessel

Inventive Principle:
Principle #32Color changes

2Ease of operation

If a straight expandable element is used in collapsed configuration, then ease of delivery is improved, but the ability to induce swirling blood flow is reduced

Engineering Contradiction:
Improveease of deliveryVSAvoidswirling blood flow induction
Core Design Contradiction:
Ease of operationVSProductivity

Solution Approach 1:

The expandable element transitions dynamically between a straight collapsed configuration for easy delivery through catheters and a curved expanded configuration for therapeutic function. This dynamic shape change allows the device to achieve both ease of delivery and swirling flow induction, with the curvature being activated only when needed at the target site

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The expandable element is designed with inherent three-dimensional curvature in its expanded state, creating the swirling blood flow pattern. The curvature is maintained in the expanded configuration to induce the therapeutic swirling flow, while the collapsed state remains substantially straight for delivery

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Ease of manufacture

If the expandable element is made inflatable using a balloon, then ease of manufacture is improved, but precision of force application is reduced

Engineering Contradiction:
Improveexpandable element fabricationVSAvoidforce application precision
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The inflatable balloon is designed with varying cross-sectional geometry along its length, including end portions with different shapes than the central portion. This local variation in geometry allows different regions of the balloon to apply force in specific directions, enabling precise control of the three-dimensional curved configuration and force application to the stent and blood vessel wall

Inventive Principle:
Principle #3Local quality

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 device minimizes thrombosis and platelet adhesion, prevents stent coverage by intima ingrowth, and effectively inhibits vascular diseases by promoting a swirling blood flow and ensuring correct stent alignment, thereby reducing the risk of neointimal hyperplasia and in-stent restenosis.

Implementation Method 1

the expandable element is configured to exert force on the internal wall of a blood vessel causing the longitudinal axis of the blood vessel to curve in three-dimensional space

Methodology Applied
Scientific EffectRadial expansion force: Mechanical Force

Implementation Method 2

Blood flowing through the three-dimensional curved part of the blood vessel undergoes a swirling action

Methodology Applied
Scientific EffectSwirling flow: Vortex Ring

Implementation Method 3

Wall shear stress is generated on the internal wall of a blood vessel by flow adjacent to the wall. Higher levels of wall shear stress have been associated with a reduction in levels of in-stent restenosis

Methodology Applied
Scientific EffectWall shear stress: Shear Stress

Data Source

PatentUS9883961B2Medical device
Publication Date: 2018.02.06 VERYAN MEDICAL LTD
  • US9883961B2 patent drawing
  • US9883961B2 patent drawing
  • US9883961B2 patent drawing

AI summary

A medical device includes an expandable element for location in a blood vessel. The expandable element is movable between a collapsed configuration and an expanded configuration. In the expanded configuration, at least a part of a longitudinal axis of the expandable element is curved in three-dimensional space. The medical device can be stent deployment device which includes an elongate catheter shaft and an inflatable balloon.