Balloon Catheter Distal Tip Structure for Guide Wire Followability

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Solution Overview

Problem

Catheters with flexible distal end members face issues with impaired followability of a guide wire due to deformation when inserted into curved blood vessels, and there is a risk of the distal end being caught by stents.

Innovation Solution

A catheter design with a distal end member having a flexible distal end portion, an intermediate portion with a hard part, and a proximal end portion, where the hard part is located in the interior and has higher crystallinity than the rest, ensuring flexibility and improved guide wire followability while reducing the risk of kinking and stent entanglement.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a hard shape maintaining body is disposed at the most distal end to improve guide wire followability, then followability is improved, but the distal end may be caught by the stent

Engineering Contradiction:

Improveguide wire followabilityVSAvoiddistal end entanglement with stent

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The distal end member is designed with non-uniform crystallinity distribution, where the central part has higher crystallinity (harder) and the outer peripheral part has lower crystallinity (softer). This local quality differentiation allows the central part to maintain shape and improve guide wire followability, while the softer outer peripheral part reduces the risk of being caught by the stent during insertion.

Inventive Principle:

Principle #3Local quality

2Object-affected harmful factors

If the distal end member is made more flexible to reduce stent entanglement, then flexibility is improved, but guide wire followability deteriorates

Engineering Contradiction:

Improvedistal end entanglement with stentVSAvoidguide wire followability

Core Design Contradiction:

Object-affected harmful factorsVSReliability

Solution Approach 1:

The distal end member incorporates a hardness gradient through controlled crystallinity distribution, with the central region being harder for shape maintenance and guide wire followability, while the outer peripheral region is softer to prevent stent entanglement. This local quality variation resolves the contradiction between flexibility and followability.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The distal end member is formed as a composite structure with regions of different crystallinity within the same material, creating a composite-like behavior where hard and soft regions coexist to simultaneously achieve followability and flexibility.

Inventive Principle:

Principle #40Composite materials

3Stability of the object's composition

If the distal end member is made uniformly hard to improve shape maintenance, then shape stability is improved, but flexibility and guide wire followability deteriorate

Engineering Contradiction:

Improveshape maintenanceVSAvoidguide wire followability

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The distal end member features localized high crystallinity in the central part for shape maintenance, while the outer peripheral part maintains lower crystallinity for flexibility. This spatial differentiation of material properties allows simultaneous achievement of shape stability and guide wire followability.

Inventive Principle:

Principle #3Local quality

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 design maintains flexibility at the distal end while enhancing guide wire followability and reducing the likelihood of kinking and entanglement with stents, improving procedural efficacy.

Implementation Method 1

crystallinity of the hard part is higher than crystallinity of other parts of the intermediate portion

Methodology Applied

Scientific EffectCrystallinity: Crystallisation

Data Source

PatentUS20250352762A1Catheter and method for manufacturing catheter

Publication Date: 2025.11.20 TERUMO KK

AI summary

A catheter capable of improving followability of a guide wire while maintaining flexibility of a most distal end portion. A balloon catheter includes an axially extending catheter shaft; and a distal end member that is provided on a distal end side of the catheter shaft and is more flexible than the catheter shaft, wherein the distal end member includes a distal end portion, an intermediate portion, and a proximal end portion in order from a distal end toward a proximal end in the axial direction, and at least a part of the intermediate portion has a harder part than the other parts of the intermediate portion adjacent to a distal end side and a proximal end side of the part, and the distal end portion and the hard part are made of the same material.