Balloon Catheter Loading Tool with Axial Slits

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Solution Overview

Problem

Current medical devices and manufacturing methods for balloon catheters often require direct handling of the balloon, which can compromise pharmacological coatings or stents, and existing tools do not adequately minimize contact with the balloon during procedures like guidewire loading and valve insertion.

Innovation Solution

A loading tool with a tubular member featuring a distal portion, a proximal portion, and a necked down region with axial slits, allowing minimal contact with the balloon by providing structural support and enabling the tool to shift between elongated and shortened configurations for reduced contact and easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If direct handling of the balloon is used during manufacturing and procedures, then ease of operation is improved, but the pharmacological coatings or stents on the balloon are compromised

Engineering Contradiction:
Improveease of handlingVSAvoidcompromise of pharmacological coatings
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The loading tool serves as an intermediary device between the operator and the balloon catheter. The tubular member with axial slits allows the operator to manipulate and load the balloon without direct contact, thereby protecting the pharmacological coatings while maintaining ease of operation. The tool enables guidewire loading and valve insertion procedures without the operator needing to handle the balloon directly.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If a rigid loading tool is used to provide structural support during valve insertion, then reliability is improved, but the tool cannot be easily removed from the catheter shaft

Engineering Contradiction:
Improvestructural supportVSAvoidease of removal
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The loading tool transitions from a rigid state during insertion to a flexible state during removal. The axial slits in the tubular member allow the tool to flex and conform to the catheter shaft during insertion, providing structural support. During removal, the slits enable the tool to expand or deform, facilitating easy extraction from the catheter shaft without damaging the balloon or catheter.

Inventive Principle:
Principle #15Dynamics

3Object-affected harmful factors

If a loading tool with minimal contact design is used, then protection of pharmacological coatings is improved, but structural support for valve insertion is reduced

Engineering Contradiction:
Improveprotection of pharmacological coatingsVSAvoidstructural support
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The loading tool distributes contact points locally rather than having continuous contact along the balloon length. The axial slits create discrete contact zones that provide sufficient structural support at critical points during valve insertion while minimizing overall contact with the pharmacological coating. This localized support approach protects the coating while maintaining necessary mechanical strength.

Inventive Principle:
Principle #3Local quality

4Ease of manufacture

If the tubular member has a uniform diameter, then manufacturing is simplified, but the tool cannot shift between elongated and shortened configurations for reduced contact

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidcontact with balloon
Core Design Contradiction:
Ease of manufactureVSObject-affected harmful factors

Solution Approach 1:

The tubular member is segmented by the axial slits that divide the wall structure into multiple sections. This segmentation allows the tool to shift between elongated and shortened configurations by enabling the segments to move relative to each other. The necked down region further divides the structure, creating distinct zones that can independently deform. This segmented design reduces contact with the balloon while remaining manufacturable through standard forming processes.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP2895228B1Loading tools for use with balloon catheters
Publication Date: 2019.11.20 BOSTON SCIENTIFIC SCIMED INC
  • EP2895228B1 patent drawingFigure 1
  • EP2895228B1 patent drawingFigure 2
  • EP2895228B1 patent drawingFigure 3

AI summary

Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a loading tool (210). The loading tool may include a tubular member that is configured to be disposed about a balloon catheter. The tubular member may include a distal portion (212) and a proximal portion (214). The tubular member may be configured to shift between a first configuration and a shortened configuration.