Medical Balloon Deflation via Local Crystallinity Control

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Solution Overview

Problem

Medical balloons used in angioplasty procedures often face challenges in folding into a predictable low profile configuration after deflation, which can lead to snagging or friction issues during withdrawal from the body, affecting the precision and reliability of the procedure.

Innovation Solution

The development of a medical balloon with a cylindrical wall formed of polymer, featuring a series of ablated and treated regions with varying flexibility and crystallinity, allowing for controlled folding into a low profile configuration upon deflation, achieved through techniques like UV radiation exposure, heating, or ion implantation, to facilitate smooth withdrawal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If the balloon is made from uniform polymer material, then manufacturing is simple, but the balloon cannot fold into a predictable low profile configuration upon deflation

Engineering Contradiction:
Improvefolding predictabilityVSAvoidballoon wall structure
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The balloon wall is divided into multiple regions with different polymer properties - some regions have higher crystallinity while others have lower crystallinity. This local variation in material properties causes different regions to fold at different rates upon deflation, creating a predictable multi-lobed configuration. The patent applies laser treatment to specific regions to modify their crystallinity, thereby controlling the folding behavior locally.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes the crystallinity parameter of the polymer in different regions of the balloon wall. By controlling the degree of crystallinity through laser treatment, the invention creates regions with different flexibility and folding characteristics. This parameter modification enables the balloon to fold into a predictable low profile configuration while maintaining manufacturing feasibility.

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If the balloon folds into a low profile configuration, then withdrawal from the body is facilitated, but the folding process may cause snagging or friction issues

Engineering Contradiction:
Improvewithdrawal smoothnessVSAvoidsnagging and friction
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The balloon is segmented into multiple lobes through the creation of multiple folding regions with different crystallinity levels. This segmentation allows the balloon to collapse into a compact multi-lobed configuration that reduces the radial profile, facilitating smoother withdrawal from the body while distributing the folding stress across multiple regions rather than creating a single point of resistance.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon wall is pre-treated with laser energy to create regions of different crystallinity before the balloon is used in the body. This preliminary modification of the polymer structure ensures that when the balloon is deflated, it will fold in a predictable manner into a low profile configuration, preventing snagging and reducing friction during withdrawal.

Inventive Principle:
Principle #10Preliminary action

3Manufacturing precision

If different regions of the balloon wall have different flexibility, then controlled folding is achieved, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvefolding controlVSAvoidballoon wall treatment process
Core Design Contradiction:
Manufacturing precisionVSEase of manufacture

Solution Approach 1:

The patent replaces complex mechanical or chemical manufacturing processes with laser treatment to create different flexibility regions in the balloon wall. The laser method provides precise control over the treatment areas and can be applied directly to the balloon material, simplifying the manufacturing process while achieving the desired differential flexibility for controlled folding.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

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 folds into a desired configuration with a low profile, reducing the risk of snagging and minimizing friction, thereby enhancing the precision and reliability of angioplasty and stent delivery procedures.

Implementation Method 1

forming a series of second treated regions alternating with the first ablated regions, the second treated regions being formed by UV radiation exposure

Methodology Applied
Scientific EffectUV radiation: Electromagnetic Induction

Implementation Method 2

forming a series of second treated regions alternating with the first ablated regions, the second treated regions being formed by UV radiation exposure, heating, or ion implantation

Methodology Applied
Scientific EffectHeating: Heating

Implementation Method 3

forming a series of second treated regions alternating with the first ablated regions, the second treated regions being formed by UV radiation exposure, heating, or ion implantation

Methodology Applied
Scientific EffectIon implantation: Ion Implantation

Implementation Method 4

forming a series of first ablated regions wherein the polymer is removed to enhance flexibility of the wall

Methodology Applied
Scientific EffectLaser ablation: Laser Ablation

Data Source

PatentUS8845581B2Medical balloon deflation
Publication Date: 2014.09.30 BOSTON SCIENTIFIC SCIMED INC
  • US8845581B2 patent drawing
  • US8845581B2 patent drawing
  • US8845581B2 patent drawing

AI summary

Medical balloons are energetically treated to form regions that facilitate deflation to a desirable configuration.