Balloon Catheter Durable Tip Segmentation

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Solution Overview

Problem

Conventional intravascular catheters often suffer from low durability at the distal tip, leading to damage during navigation through tortuous anatomy, particularly at narrow restrictions or occlusions, which can result in deformation and flaring, compromising performance and increasing the risk of tip damage.

Innovation Solution

A catheter design featuring a durable polymeric distal tip structure with a distal ring portion made of harder material than the shaft, combined with a laterally flexible proximal portion, enhancing resistance to deformation and flaring, and potentially incorporating radiopaque materials for improved visibility during procedures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the catheter tip is made of flexible material to maintain trackability and flexibility, then the catheter can navigate tortuous anatomy, but the tip durability decreases and deformation/flaring occurs during navigation

Engineering Contradiction:
Improvetip durabilityVSAvoidresistance to deformation
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The catheter tip is divided into two distinct segments: a proximal portion made of flexible polymer material for navigation, and a distal portion made of harder, more durable material for resistance to deformation and flaring. This segmentation allows each portion to optimize its specific function without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the catheter tip are assigned different material properties: the proximal portion uses flexible material for trackability, while the distal portion uses harder material for durability and deformation resistance. This local differentiation of material quality resolves the contradiction between flexibility and strength.

Inventive Principle:
Principle #3Local quality

2Reliability

If the distal tip structure uses harder material to increase durability and resistance to deformation, then the catheter withstands navigation forces, but lateral flexibility decreases

Engineering Contradiction:
ImprovedurabilityVSAvoidlateral flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The catheter tip is segmented into a proximal portion with higher lateral flexibility for manipulation and a distal portion with higher durability for withstanding navigation forces. This segmentation allows the harder material to be placed only where needed for durability, while preserving flexibility where needed for operation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The proximal portion of the tip structure is made with higher lateral flexibility to facilitate manipulation and navigation, while the distal portion is made with higher durability to resist deformation during navigation through tortuous anatomy. This local quality differentiation resolves the contradiction between ease of operation and reliability.

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP2252360B1Balloon catheter with durable tip portion
Publication Date: 2018.05.16 BOSTON SCIENTIFIC SCIMED INC
  • EP2252360B1 patent drawingFigure 1
  • EP2252360B1 patent drawingFigure 2
  • EP2252360B1 patent drawingFigure 3

AI summary

A durable distal tip structure for an intravascular catheter that may include a distal portion comprising a ring of durable material configured to provide a durable distal tip to the catheter, and a proximal portion extending proximally from the distal portion and configured for connecting the distal tip structure to the catheter, wherein the proximal portion of the distal tip structure is more laterally flexible than the distal portion. In some cases, the durable distal tip structure comprises a metal or metal alloy, and in some cases, the distal ring portion and proximal portion of the durable distal tip structure comprise a single monolith of material. Also, catheters including such durable distal tip structures, and methods of making and using such catheters. In some cases, the catheter is a balloon catheter. In some other embodiments, the catheter is a stent delivery catheter for a self expanding stent.