Balloon Catheter Radiopaque Marker Polymer Coating

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Solution Overview

Problem

Existing balloon catheters face issues with X-ray marker attachment methods, such as sharp edges causing balloon perforation, inaccurate positioning, and increased rigidity, which affect the catheter's functionality and production efficiency.

Innovation Solution

A balloon catheter with X-ray-visible markers applied as a coating on a polymer carrier, avoiding sharp edges and allowing precise positioning, combined with a flexible polymer support for improved flexibility and ease of manufacturing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If round platinum or gold sleeves are used as X-ray markers and attached via swaging process, then X-ray visibility is achieved, but sharp edges are created that can perforate the balloon

Engineering Contradiction:
ImproveX-ray marker visibilityVSAvoidsharp edges causing balloon perforation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent combines a polymer carrier material with an X-ray visible material (such as tungsten, barium, or lead oxide) to create a composite marker. This composite structure provides both X-ray visibility and flexibility, eliminating the sharp edges problem associated with pure metal sleeves while maintaining reliable X-ray detection capability.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent changes the physical state and form of the X-ray visible material from solid metal sleeves to a distributed coating or filling within a polymer matrix. This parameter change transforms the rigid, edge-prone structure into a flexible, edge-free composite material that maintains X-ray visibility without causing balloon perforation.

Inventive Principle:
Principle #35Parameter changes

2Manufacturing precision

If round hammering is used to attach markers to the inner shaft, then markers are fixed in position, but the force causes marker displacement and narrows the inner channel

Engineering Contradiction:
Improvemarker position accuracyVSAvoidinner channel narrowing
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent replaces the mechanical swaging process with a chemical bonding approach. The polymer carrier material is bonded to the inner shaft through adhesive bonding or integration during balloon expansion, eliminating the need for forceful mechanical attachment that causes displacement and channel narrowing.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent separates the marker function from the structural attachment function. The polymer carrier provides the structural interface with the inner shaft, while the X-ray visible material provides the radiopacity. This segmentation allows each component to optimize its function without interfering with the other.

Inventive Principle:
Principle #1Segmentation

3Reliability

If metal sleeves are used as markers, then X-ray visibility is achieved, but the rigidity makes it difficult to move the catheter through vessels

Engineering Contradiction:
ImproveX-ray marker visibilityVSAvoidcatheter flexibility
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent creates a composite marker where a flexible polymer carrier is combined with an X-ray visible material. The polymer provides flexibility for catheter navigation through vessels, while the embedded or coated X-ray visible material (such as tungsten or barium) provides the necessary radiopacity for imaging.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent uses a flexible polymer carrier as the base structure for the marker. This flexible polymer shell or film can bend and conform to the catheter's movement through tortuous vessels, unlike rigid metal sleeves. The X-ray visible material is incorporated within or on this flexible matrix to maintain visibility.

Inventive Principle:
Principle #30Flexible shells and thin films

4Reliability

If polymer markers filled with tungsten are used, then X-ray visibility is achieved, but the thickness increases the cross section of the catheter

Engineering Contradiction:
ImproveX-ray marker visibilityVSAvoidcatheter cross section
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The patent optimizes the distribution and concentration of the X-ray visible material within the polymer carrier. By controlling the thickness and density of the X-ray visible material layer or filling, the marker achieves adequate radiopacity with minimal increase in catheter cross-section.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies the X-ray visible material selectively in specific regions or concentrations within the polymer carrier, rather than uniformly throughout. This local concentration strategy provides sufficient X-ray visibility in critical areas while minimizing the overall volume and cross-sectional increase of the catheter.

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 solution ensures reliable balloon dilation, precise positioning, and reduced production costs, enabling accurate X-ray visibility and easier navigation through vascular ducts.

Implementation Method 1

the at least one marker has a material that is visible to X-rays

Methodology Applied
Scientific EffectX-ray absorption: Absorption (EM radiation)

Data Source

PatentEP3243547A1Balloon catheter with radiopaque marker
Publication Date: 2017.11.15 BIOTRONIK AG
  • EP3243547A1 patent drawingFigure 1~3
  • EP3243547A1 patent drawingFigure 2a~2c
  • EP3243547A1 patent drawingFigure 4a~4c

AI summary

The application relates to a balloon catheter (10) comprising an expandable balloon (12), an inner shaft (13) arranged within the balloon (12), and at least one marker (15, 16, 31, 32), wherein the at least one marker (15, 16, 31, 32) comprises a radiopaque material. To achieve high radiolucency while avoiding sharp edges on the radiopaque marker and to ensure precise positioning of the radiopaque marker, the radiopaque material is formed as a coating on and/or within a polymer carrier (14, 30), and the polymer carrier (14, 30) is attached to the inner shaft (13). A simple and cost-effective method for manufacturing such a balloon catheter (10) is also described.