Swellable Coating on X-ray Markers for Absorbable Scaffolds

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Solution Overview

Problem

Medical implants with X-ray markers face challenges in corrosion due to interaction with the framework, especially in aqueous environments, leading to reduced X-ray visibility and increased corrosion rates, which can result in undesirable biological reactions.

Innovation Solution

A medical implant with a swellable, electrically insulating coating on monolithic X-ray markers that increases in volume upon contact with water, preventing contact with the framework and ensuring self-centering and self-passivation, thereby reducing corrosion risks.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a solid X-ray marker is bonded into the eyelet of an absorbable scaffold, then the marker position can be determined, but corrosion-promoting contact between the marker and scaffold occurs due to adhesive gap displacement

Engineering Contradiction:
ImproveX-ray marker visibilityVSAvoidcorrosion resistance
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

A polymer coating is applied as an intermediary layer between the X-ray marker and the absorbable scaffold. This coating prevents direct metallic contact between the marker and scaffold, eliminating galvanic corrosion while maintaining the marker's X-ray visibility and positional stability throughout the scaffold's degradation process.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The polymer coating's physical state changes from a liquid or paste application state to a solid protective layer after curing. This parameter change enables the coating to fill irregularities in the eyelet-marker interface and maintain stable separation as the scaffold degrades, preventing adhesive gap displacement and marker migration.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If composite radiopaque markers with high radiopaque particle content are used, then X-ray visibility is improved, but the mixture becomes too viscous for processing

Engineering Contradiction:
Improveradiographic visibilityVSAvoidprocessing feasibility
Core Design Contradiction:
Measurement precisionVSEase of manufacture

Solution Approach 1:

The radiopaque function is extracted from the adhesive composite and concentrated into a separate, pre-formed solid X-ray marker. This allows the marker to achieve high radiopaque particle content (up to 100% by weight) for optimal X-ray visibility without the viscosity constraints that would prevent processing if such high concentrations were used in an injectable adhesive.

Inventive Principle:
Principle #2Taking out (Extraction)

3Reliability

If the adhesive gap is uniformly distributed around the marker circumference, then marker displacement is prevented, but technological limitations prevent uniform distribution

Engineering Contradiction:
Improvemarker position stabilityVSAvoidadhesive gap uniformity
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The polymer coating transforms from an application state (liquid or paste) to a final solid state, during which it shrinks and conforms to the marker surface. This parameter change enables the coating to uniformly fill the eyelet space around the marker circumference, creating consistent spacing and preventing marker displacement without requiring precise control of adhesive gap uniformity during assembly.

Inventive Principle:
Principle #35Parameter changes

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 swellable coating effectively prevents corrosion by spacing the X-ray markers from the framework, maintaining X-ray visibility and ensuring the degradation process is not interrupted, while simplifying the manufacturing process and reducing the risk of local element formation.

Implementation Method 1

the coating is designed to be swellable such that it experiences an increase in volume upon contact with a water-containing medium

Methodology Applied
Scientific EffectSwelling: Hydrogel

Data Source

PatentEP3281648B1X-ray marker for absorbable metallic scaffolds having high x-ray visibility and integrated self-passivation effect
Publication Date: 2020.09.02 CORTRONIK
  • EP3281648B1 patent drawingFigure 1
  • EP3281648B1 patent drawingFigure 2
  • EP3281648B1 patent drawingFigure 3

AI summary

The invention relates to a medical implant comprising: a framework (1) having at least one receptacle (2) for an X-ray marker (5), wherein the framework (1) comprises a first metal, and at least one X-ray marker (5) arranged in the receptacle (10), wherein the X-ray marker (5) comprises a second metal. According to the invention, the X-ray marker (5) comprises a second metal, and an electrically insulating coating (3) is applied to the X-ray marker (5) to prevent corrosion-promoting contact between the X-ray marker (5) and the framework (1).