Balloon Coating via Core Member Rotation

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Solution Overview

Problem

Current balloon coating methods fail to consistently control the morphological form of drugs on balloon catheters, leading to inconsistent drug release and transfer to tissue, which is crucial for preventing restenosis.

Innovation Solution

A balloon coating method involving a core member inserted into the guide wire lumen, with the core member's distal portion protruding beyond the distal opening and proximal portion positioned proximally, allows for stable rotation and fixation of the balloon, enabling precise application of a coating liquid and setting the morphological form of the drug coating.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If the balloon is clamped for coating application, then the balloon position is fixed, but the balloon may deform due to crushing

Engineering Contradiction:
Improvecoating uniformityVSAvoidballoon shape
Core Design Contradiction:
Manufacturing precisionVSShape

Solution Approach 1:

A core member is inserted into the guide wire lumen of the balloon catheter to act as an intermediary support structure. The core member has a distal portion that protrudes beyond the distal opening and a proximal portion positioned proximally, providing internal scaffolding that prevents balloon deformation during clamping and coating application, while allowing the balloon to be securely held for precise coating.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Manufacturing precision

If the balloon rotates during coating, then the coating can be applied uniformly, but the balloon position may fluctuate

Engineering Contradiction:
Improvecoating uniformityVSAvoidposition stability
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The core member serves as a stable intermediary structure that anchors the balloon during rotation. By providing internal support through the guide wire lumen, the core member allows the balloon to rotate smoothly for uniform coating application while the clamping mechanism maintains overall position stability, preventing unwanted position fluctuations.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Strength

If the core member protrudes distally beyond the guide wire lumen opening, then the balloon is protected from crushing, but the device complexity increases

Engineering Contradiction:
Improveballoon protectionVSAvoidcore member configuration
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The core member is designed to perform multiple functions: it provides internal support to prevent balloon crushing, anchors the balloon during clamping, and enables stable rotation for coating. This multi-functional design justifies the additional structural element, as a single component addresses multiple critical needs during the coating process.

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

This method ensures appropriate drug morphological form on the balloon surface, enhancing drug release and transfer to the lesion site, effectively preventing restenosis by maintaining the balloon's shape and position during coating, thus optimizing drug delivery.

Implementation Method 1

the length of time of volatilization of the solvent

Methodology Applied
Scientific EffectVolatilization: Evaporation

Data Source

PatentUS10369334B2Balloon coating method and balloon rotating method
Publication Date: 2019.08.06 TERUMO KK
  • US10369334B2 patent drawing
  • US10369334B2 patent drawing
  • US10369334B2 patent drawing

AI summary

A balloon coating method for forming a coating layer on the outer surface of a balloon of a balloon catheter includes: inserting a core member into a guide wire lumen penetrating the balloon, disposing a proximal portion of the core member on a proximal side of a region of inflation of the balloon, with a distal portion of the core member protruded distally beyond a distal opening portion of the guide wire lumen, and fixing by clamping together with the core member a part of the balloon catheter that is on a distal side of the region of inflation; and moving a dispensing tube for supplying a coating liquid containing the drug relative to the balloon in an axial direction of the balloon, while rotating the balloon about an axis of the balloon, thereby to apply the coating liquid to the outer surface of the balloon.