Nested Tubular Insertion Tool for Balloon Catheter Protection

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Solution Overview

Problem

Existing insertion tools for medical devices into the vasculature often fail to adequately protect drug coatings from contamination and accidental contact with fluids, and they do not effectively facilitate the insertion of medical devices like balloon catheters and stents while ensuring safe handling for healthcare professionals.

Innovation Solution

The development of insertion tools with features such as tubular members with separation margins and ridges that allow for easy fracture, tapered ends, and locking mechanisms to secure and guide medical devices, along with designs that fit within hemostatic valves, enabling safe and controlled insertion while minimizing contact with drug coatings.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If existing insertion tools are used, then medical devices can be inserted into the vasculature, but drug coatings are not adequately protected from contamination and accidental contact with fluids

Engineering Contradiction:
Improvecontamination of drug coatingsVSAvoidprotection of drug coatings
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The insertion tool employs a nested structure where an inner tubular member is positioned within an outer tubular member. The inner member protects the drug-coated medical device during insertion, while the outer member provides additional protection and structural support. This nested configuration ensures multiple layers of protection for the drug coating without compromising insertion capability.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The insertion tool acts as an intermediary between the drug-coated medical device and the external environment (fluids, contamination). By introducing this intermediate structure with controlled access points, the tool mediates the insertion process while maintaining isolation of the drug coating from harmful external factors.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If existing insertion tools are used, then medical devices can be inserted, but safe handling for healthcare professionals is not ensured due to contact with drug coatings

Engineering Contradiction:
Improvesafe handlingVSAvoidcontact with drug coatings
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The nested tubular structure creates multiple barriers between healthcare professionals and drug coatings. The inner tubular member encloses the drug-coated device, while the outer tubular member provides an additional protective layer, enabling safe handling during the insertion procedure.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The insertion tool serves as a protective intermediary that allows healthcare professionals to manipulate and insert the medical device without direct contact with the drug coating, thereby ensuring safe handling while maintaining operational ease.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If the tubular member is made robust for protection, then drug coatings are protected, but the tool becomes difficult to fracture for device release

Engineering Contradiction:
Improveprotection during insertionVSAvoidfracture for device release
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The tubular member exhibits local quality variations with different wall thicknesses at different locations. The proximal portion has greater thickness for enhanced protection during insertion, while the distal portion has reduced thickness to facilitate fracturing for device release. This non-uniform thickness distribution resolves the contradiction between protection and ease of release.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The tubular member is effectively segmented into functional zones with different mechanical properties. The proximal segment provides robust protection, while the distal segment is designed for controlled fracturing. This segmentation allows the single component to fulfill both protective and release functions.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3244960B1Insertion tools for medical device
Publication Date: 2024.01.10 SURMODICS INC
  • EP3244960B1 patent drawingFigure 1a~1f
  • EP3244960B1 patent drawingFigure 2a~2c
  • EP3244960B1 patent drawingFigure 2D~2G

AI summary

The disclosure provides insertion tools and articles that facilitate entry of a medical device, such as a balloon catheter, into the body. In embodiments the insertion tools have an elongate hollow body (50) that is able to protect a portion of a medical device, such as a balloon of a balloon catheter, during an insertion procedure. In one embodiment the insertion tool has an elongate hollow body (131), a tapered distal end (135), and a locking mechanism (133) at the proximal end which can secure a portion of a balloon catheter. An opening at the distal end can allow passage of the balloon in a folded uninflated state.