Balloon Orientation Distribution Control

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Solution Overview

Problem

Balloon catheters are prone to rupture in the circumferential direction due to unexpected increases in internal pressure or contact with hardened biological tissue, leading to potential breakage and fragment separation.

Innovation Solution

A balloon with a multi-layer structure made from different polymer materials, where the ratio of orientation distributions in the circumferential direction is controlled to be less than 2, and the stretching speed during manufacturing is optimized to prevent rupture, ensuring the balloon can withstand pressure without axial or circumferential failure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the balloon is made with conventional single-layer structure and standard stretching process, then the manufacturing process is simple, but the balloon is prone to circumferential rupture under unexpected pressure increase or contact with hardened tissue

Engineering Contradiction:
Improveresistance to circumferential ruptureVSAvoidmulti-layer structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The balloon is constructed with a multi-layer structure comprising an inner layer, intermediate layer, and outer layer, where each layer has different material properties. The intermediate layer specifically has a controlled orientation distribution ratio less than 2, creating a composite structure that prevents circumferential rupture while maintaining manufacturing feasibility.

Inventive Principle:
Principle #40Composite materials

2Productivity

If the stretching speed is increased to improve productivity, then the manufacturing efficiency increases, but the orientation distribution ratio becomes uncontrolled and circumferential rupture risk increases

Engineering Contradiction:
Improvestretching speedVSAvoidorientation distribution ratio control
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent specifies a controlled stretching speed range of 5-50 mm/s during the stretching process. This parameter control ensures that the orientation distribution ratio in the intermediate layer remains less than 2, preventing circumferential rupture while maintaining acceptable manufacturing productivity.

Inventive Principle:
Principle #35Parameter changes

3Object-affected harmful factors

If the balloon wall is made thinner to reduce trauma during insertion, then the insertion trauma decreases, but the pressure resistance and shock resistance are reduced

Engineering Contradiction:
Improveinsertion traumaVSAvoidpressure resistance
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The multi-layer composite structure allows each layer to have optimized thickness and material properties. The intermediate layer with controlled orientation distribution provides enhanced circumferential strength, enabling the balloon to maintain pressure resistance even with reduced overall wall thickness, thereby reducing insertion trauma.

Inventive Principle:
Principle #40Composite materials

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 balloon effectively prevents circumferential rupture and enhances pressure resistance, maintaining structural integrity during medical procedures such as stent delivery and cardiovascular interventions.

Implementation Method 1

a heated tubular parison is expanded by pressure applied to the inside of the tubular parison while the heated tubular parison is stretched in the axial direction

Methodology Applied
Scientific EffectPressure expansion: Pressure Increase

Implementation Method 2

the cylindrical portion can be molded so as to cause the ratio of the number of orientation distributions to be less than 2, by controlling a stretching speed

Methodology Applied
Scientific EffectOrientation control through stretching: Deformation

Data Source

PatentEP2974766B1Balloon and production method for same
Publication Date: 2022.09.21 TERUMO KK
  • EP2974766B1 patent drawingFigure 1~2
  • EP2974766B1 patent drawingFigure 3
  • EP2974766B1 patent drawingFigure 4

AI summary

[Problem] Provided is a balloon in which a rupture in a circumferential direction can be prevented from occurring, and a method of manufacturing the same. [Means for Resolution] Provided a balloon (30) which is arranged on a medical catheter, and includes a dilatable cylindrical portion (42) that is formed with a birefringent polymer material. A ratio of the number of orientation distributions calculated by dividing the number of orientation distributions of the cylindrical portion (42) in a circumferential direction by the number of orientation distributions of the cylindrical portion (42) in an axial direction is less than 2.