Balloon Expandable Stent Inducing Spiral Flow

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Solution Overview

Problem

Existing balloon expanded stent delivery systems face challenges in consistently imparting a spiral shape to stents during deployment, which is necessary to induce spiral flow and reduce thrombosis and restenosis, as modifying balloons and stents with helical constraints is problematic for mass production.

Innovation Solution

A balloon expanded stent delivery system that includes a balloon mounted on a catheter with a spirally wound inflation constraint, which constrains the balloon to a spiral shape upon inflation, imprinting a matching spiral contour on the stent, allowing the stent to retain the flow directing surface after deployment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If helical plastic strips are attached to the balloon surface to create spiral flow, then spiral flow is induced and thrombosis is reduced, but manufacturing complexity increases and mass production becomes problematic

Engineering Contradiction:
Improvethrombosis reductionVSAvoidmanufacturing complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent removes the complex helical plastic strips from the system and replaces them with a simple wire constraint mechanism attached to the catheter, extracting the problematic component while preserving the spiral flow function

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent introduces a wire constraint as an intermediary element between the catheter and the balloon, which indirectly shapes the balloon into a spiral configuration during inflation, avoiding direct modification of the balloon surface

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If helical constraints are modified on stents to produce spiral flow, then thrombosis is reduced, but manufacturing precision requirements increase

Engineering Contradiction:
Improvethrombosis reductionVSAvoidspiral contour precision
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The wire constraint is pre-formed with the desired spiral geometry before deployment, and this pre-formed constraint automatically imprints the spiral shape on the stent during balloon inflation, eliminating the need for complex post-manufacturing adjustments

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The wire constraint acts as a physical template or mold that copies its spiral geometry onto the balloon and subsequently onto the stent, ensuring consistent spiral contours without requiring high-precision manufacturing of each individual stent

Inventive Principle:
Principle #26Copying

3Shape

If the balloon is constrained to a spiral shape during inflation, then a spiral contour is imprinted on the stent, but the balloon requires additional constraint structures

Engineering Contradiction:
Improvespiral contourVSAvoidconstraint structure
Core Design Contradiction:
ShapeVSDevice complexity

Solution Approach 1:

The wire constraint is a flexible, thin element that can conform to the balloon surface while maintaining its spiral geometry, providing the necessary constraint without adding bulky or complex structures

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The wire constraint serves multiple functions: it maintains catheter stability, shapes the balloon into a spiral configuration, and imprints the spiral contour on the stent, eliminating the need for separate constraint mechanisms

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 system effectively induces spiral flow, increasing sheer stress at the stent surface, potentially reducing thrombosis and restenosis, while using conventional stents and balloon catheters with minimal modifications, offering adaptability and cost-effectiveness.

Implementation Method 1

a wire attached to the catheter and spirally wrapped on the balloon... the wire constrains the inflated balloon to a spiral shape

Methodology Applied
Scientific EffectMechanical constraint: Mechanical Force

Data Source

PatentEP3308750B1A balloon expandable stent for inducing spiral flow
Publication Date: 2020.09.30 COOK MEDICAL TECHNOLOGIES LLC
  • EP3308750B1 patent drawingFigure 1~9
  • EP3308750B1 patent drawingFigure 10~14
  • EP3308750B1 patent drawingFigure 15~17

AI summary

A balloon expanded stent delivery system includes an inflation constraint, such as a wire, spirally wound about the longitudinal axis in contact with a balloon and attached to an underlying catheter. A balloon expanded stent is mounted about the balloon and the inflation constraint. The delivery system has a predeployment configuration with the balloon deflated and the stent unexpanded. The system has a deployment configuration in which the inflation constraint constrains the inflated balloon to a spiral shape, the stent is expanded and in contact with the balloon, and the stent has a flow directing surface with a spiral contour that matches the spiral shape of the balloon. In a postdeployment configuration, the stent retains the flow directing surface with the spiral contour.