X-Ray Marker Break-Off Structure for Corrosion-Safe Scaffold Integration

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Solution Overview

Problem

Current methods for producing x-ray markers face challenges in achieving high radiopacity while maintaining minimal preparative effort and preventing corrosion-accelerating local elements, especially when integrated with degradable scaffolds like stents, due to limitations in material composition and processing viscosity.

Innovation Solution

A method involving pre-cutting x-ray markers with inwardly offset breaking points connected via webs, allowing for efficient handling and production in large quantities, with passivation to prevent corrosion, and integration into stent frameworks without direct metal-metal contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the fraction of x-ray-absorbing particles in composite markers is increased to improve radiopacity, then radiopacity is improved, but the mixture becomes too viscous for processing

Engineering Contradiction:
ImproveradiopacityVSAvoidprocessing viscosity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent uses solid x-ray markers made from highly radiopaque materials (tungsten, tantalum, or their alloys) that are designed to be rigid and permanent rather than composite materials that would require continuous processing. These solid markers are inserted into eyelets of the scaffold, eliminating the need for viscous composite materials and enabling high radiopacity without processing viscosity issues.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Reliability

If solid markers are adhesively bonded into eyelets to improve radiopacity, then radiopacity is improved, but corrosion-accelerating local elements form due to direct metal contact

Engineering Contradiction:
ImproveradiopacityVSAvoidcorrosion risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a polymer adhesive as an intermediary substance between the solid x-ray marker and the scaffold eyelet. This adhesive layer prevents direct electrical contact between the marker and the scaffold, thereby eliminating the formation of corrosion-accelerating local elements while still providing secure mechanical bonding. The adhesive acts as a protective barrier that maintains both radiopacity and corrosion resistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If degradable scaffolds are used to improve biocompatibility, then biocompatibility is improved, but the geometric positions of components shift during degradation

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidgeometric position stability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The patent employs adhesive bonding as a preliminary action that creates a strong mechanical connection between the x-ray marker and the scaffold eyelet before degradation occurs. This adhesive bonding pre-establishes the geometric relationship and prevents shifting during the degradation process. The adhesive acts as a stabilizing element that maintains component positions throughout the scaffold's service life and degradation timeline.

Inventive Principle:
Principle #10Preliminary action

4Object-affected harmful factors

If complex production methods are used to prevent local element formation, then corrosion resistance is improved, but production effort and complexity increase

Engineering Contradiction:
Improvecorrosion resistanceVSAvoidproduction complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent uses a simple polymer adhesive as an intermediary material that can be easily applied during standard manufacturing processes. This approach provides corrosion protection through a straightforward adhesive bonding step rather than requiring complex multi-stage processes such as galvanic deposition or multiple coating layers. The adhesive serves as a simple yet effective barrier that reduces production complexity while maintaining corrosion resistance.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Enables the production of numerous x-ray markers with consistent properties, improved handling, and reduced corrosion risks, facilitating their integration into stent frameworks while maintaining radiopacity and mechanical strength.

Implementation Method 1

The invention relates to a method for producing x-ray markers... at least one highly absorbent x-ray marker surface... made of tungsten and/or tantalum

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

Implementation Method 2

the x-ray marker (1) is provided with an oxide layer by plasma-chemical oxidation in an electrolyte, such that a surface passivation is achieved

Methodology Applied
Scientific EffectPassivation: Oxidation

Data Source

PatentUS20240207076A1X-ray markers for scaffolds, semifinished product, and medical implant
Publication Date: 2024.06.27 BIOTRONIK AG
  • US20240207076A1 patent drawing
  • US20240207076A1 patent drawing
  • US20240207076A1 patent drawing

AI summary

An x-ray marker is formed by detaching the x-ray marker from a material layer by severing at a predetermined breaking point. A contact face of the breaking point between two adjacent edge portions lies farther inward into the x-ray marker than the edge portions between which the breaking point is disposed. There is also described a semifinished product and a medical implant with an x-ray marker.