Scaffold X-Ray Marker Fabrication With Corrosion Isolation

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Solution Overview

Problem

Existing 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 the mass fraction of x-ray-absorbing particles and potential metal-metal contact.

Innovation Solution

A method involving pre-cutting of material layers to create x-ray markers with inwardly offset breaking points, allowing for efficient handling and production of large quantities with minimal mechanical strength loss, and subsequent passivation to prevent corrosion, using techniques like laser cutting and plasma-chemical oxidation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Illumination intensity

If the mass fraction of x-ray-absorbing particles in composite markers is increased to improve radiopacity, then the radiopacity improves, but the mixture becomes too viscous for processing and the density is reduced due to volume ratios

Engineering Contradiction:
ImproveradiopacityVSAvoidprocessability
Core Design Contradiction:
Illumination intensityVSEase of manufacture

Solution Approach 1:

The patent uses solid x-ray markers made from highly radiopaque materials (tungsten, tantalum, gold, platinum, or their alloys) that are discarded after serving their imaging function. These solid markers replace the composite particle approach, allowing use of 100% radiopaque material without viscosity constraints, while the markers remain in the body to fulfill their imaging purpose throughout the implant's lifecycle

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

Solution Approach 2:

The patent creates a composite structure where solid x-ray markers are integrated into the scaffold framework. The markers are made from radiopaque materials combined with the scaffold material through adhesive bonding or mechanical insertion, achieving high radiopacity (using full-density radiopaque materials rather than particle composites) while maintaining structural integrity and processability

Inventive Principle:
Principle #40Composite materials

2Illumination intensity

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

Engineering Contradiction:
ImproveradiopacityVSAvoidcorrosion acceleration
Core Design Contradiction:
Illumination intensityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a polymer adhesive as an intermediary layer between the solid x-ray marker and the scaffold. This adhesive layer prevents direct electrical contact between dissimilar metals (the radiopaque marker and the scaffold material), thereby eliminating galvanic corrosion while maintaining the mechanical bond and radiopacity benefits

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent uses a thin polymer adhesive film to isolate the metal marker from the metal scaffold. This flexible film maintains the mechanical connection while providing electrical insulation, preventing corrosion-accelerating local elements from forming at the interface between different metals

Inventive Principle:
Principle #30Flexible shells and thin films

3Adaptability or versatility

If degradable scaffolds are used to improve biocompatibility and resorption, then biocompatibility improves, but the geometric position of components shifts during degradation

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

Solution Approach 1:

The patent performs preliminary actions to ensure marker stability: the solid markers are precisely positioned and strongly bonded to the scaffold framework before implantation. The adhesive bonding or mechanical insertion methods ensure that markers remain fixed in their designated locations even as the scaffold undergoes degradation and dimensional changes over time

Inventive Principle:
Principle #10Preliminary action

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, reducing the risk of corrosion and improving handling, while maintaining radiopacity and mechanical strength, thus facilitating their integration with scaffolds without accelerating corrosion.

Implementation Method 1

said pre-cutting being performed by means of laser light

Methodology Applied
Scientific EffectLaser: Laser

Implementation Method 2

the at least one predetermined breaking point being severed in order to release the x-ray marker from said part of the material layer

Methodology Applied
Scientific EffectOxidation: Oxidation

Data Source

PatentUS11951024B2X-ray markers for scaffolds
Publication Date: 2024.04.09 BIOTRONIK AG
  • US11951024B2 patent drawing
  • US11951024B2 patent drawing
  • US11951024B2 patent drawing

AI summary

A method for producing x-ray markers. During the process, a predetermined breaking point is severed in order to detach x-ray markers from part of a material layer. There is also described an x-ray marker, a medical implant, and a semifinished product.