Medical Balloon Surface Modification for Compact Folding

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Solution Overview

Problem

Conventional medical balloons face challenges in folding and removing from occluded vessels due to their size and potential for causing complications, as they do not efficiently transition from expanded to deflated states, leading to difficulties in vascular procedures.

Innovation Solution

A medical balloon with selectively modified regions of carbonized, oxidized, or crosslinked polymer layers, arranged in specific patterns to facilitate folding into multiple lobes, allowing for a smaller profile and enhanced resilience, is developed. These regions are created through plasma immersion ion implantation, enabling the balloon to fold into a compact shape for easier removal and improved safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If a conventional medical balloon is expanded and then deflated, then the balloon returns to its original size, but the balloon maintains a large profile that makes it difficult to remove from occluded vessels

Engineering Contradiction:
Improveballoon profile sizeVSAvoidease of removal from vessel
Core Design Contradiction:
Volume of moving objectVSEase of operation

Solution Approach 1:

The balloon surface is segmented into multiple regions with different mechanical properties - some regions are modified to be more compliant while others remain stiffer. This segmentation allows the balloon to fold into multiple lobes rather than maintaining a single large structure, enabling easier removal from vessels.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different regions of the balloon are given different local qualities through selective modification. The modified regions have altered polymer properties (carbonized, oxidized, or crosslinked layers) that make them more compliant and prone to folding, while unmodified regions maintain the original structural integrity. This local differentiation enables the balloon to collapse into a compact configuration for easy removal.

Inventive Principle:
Principle #3Local quality

2Strength

If the balloon wall is made stiffer to maintain structural integrity during expansion, then burst strength is improved, but the balloon becomes more difficult to fold and remove

Engineering Contradiction:
Improveburst strengthVSAvoidfolding capability
Core Design Contradiction:
StrengthVSShape

Solution Approach 1:

The balloon structure is divided into modified and unmodified regions, allowing different mechanical properties in different locations. The unmodified regions provide the necessary burst strength and structural integrity, while the modified regions provide compliance and folding capability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The balloon wall has non-uniform local quality with modified regions containing polymer layers (carbonized, oxidized, or crosslinked) that alter local compliance. These modified regions are strategically positioned to enable folding without compromising the overall structural strength needed to withstand expansion pressures.

Inventive Principle:
Principle #3Local quality

3Shape

If selective regions of the balloon are modified with polymer layers, then folding behavior is improved, but the manufacturing process becomes more complex

Engineering Contradiction:
Improvefolding configurationVSAvoidmanufacturing complexity
Core Design Contradiction:
ShapeVSEase of manufacture

Solution Approach 1:

The mechanical approach of physically folding or crimping the balloon during manufacturing is replaced with a chemical/physical modification approach using plasma immersion ion implantation. This process selectively modifies polymer regions through ion bombardment, creating the desired folding behavior without complex mechanical manipulation steps.

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

Solution Approach 2:

The manufacturing process utilizes parameter changes in the plasma immersion ion implantation process (ion energy, ion flux, treatment time, gas composition) to control the depth and nature of polymer modification. By adjusting these parameters, different folding patterns and compliance levels can be achieved without changing the fundamental manufacturing approach.

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 modified balloon achieves a smaller profile upon deflation, facilitating easier withdrawal from vessels and reducing the risk of complications, while maintaining burst strength and mechanical properties, thus enhancing safety and usability in medical procedures.

Implementation Method 1

exposing portions of an inflatable balloon to an ion source, wherein the portions cover between about 20% to about 50% of the balloon surface

Methodology Applied
Scientific EffectIon implantation: Ion Implantation

Implementation Method 2

The carbonized polymer layer can be at a depth of between about 1 and 100 nanometers. The carbonized polymer layer can include diamond-like or graphitic material. The carbonized polymer layer can have a 500 Vickers Hardness (kgf/mm2) or more.

Methodology Applied
Scientific EffectCarbonization: Pyrolysis

Implementation Method 3

The second region can include an oxidized polymer layer, the carbonized polymer layer, and a crosslinked polymer layer. The oxidized polymer layer can be directly bonded to the carbonized polymer layer.

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 4

The crosslinked polymer layer can be at a depth of between about 100 and 1500 nanometers. The crosslinked polymer can be directly bonded to the carbonized polymer layer and to a substantially unmodified polymer material.

Methodology Applied
Scientific EffectCrosslinking: Chemical Bonding

Data Source

PatentUS7963942B2Medical balloons with modified surfaces
Publication Date: 2011.06.21 BOSTON SCIENTIFIC SCIMED INC
  • US7963942B2 patent drawing
  • US7963942B2 patent drawing
  • US7963942B2 patent drawing

AI summary

Medical balloons are described that have modified regions that enhance folding of the balloon.