Zinc Alloy Implant with Complexing Agent Coating

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Solution Overview

Problem

Zinc-containing implantable devices, such as vascular stents, can cause sensitization reactions in surrounding tissues due to the corrosion of pure zinc or zinc alloys, leading to potential safety hazards like stent blocking and mortality risks, as free zinc ions are generated and not effectively managed.

Innovation Solution

An implantable device with a substrate made of pure zinc or zinc alloy, combined with a zinc complexing agent and an anti-allergic drug, forms a complex in body fluids to reduce the number of free zinc ions, thereby minimizing tissue sensitization. The zinc alloy includes nutrient or low-toxicity elements like iron, magnesium, and the anti-allergic drug is selected from various groups including antihistamines and glucocorticoids, which are applied in specific concentrations and forms to inhibit sensitization effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If pure zinc or zinc alloy is used as the substrate material for implantable devices, then good flexibility and biocompatibility are achieved, but free zinc ions are generated through corrosion causing sensitization reactions and safety hazards

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidsensitization reaction
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A coating layer comprising a polymer matrix and zinc complexing agents is applied to the zinc substrate. The zinc complexing agents act as intermediaries that bind to free zinc ions released from the substrate through corrosion, forming stable complexes. This prevents the zinc ions from causing sensitization reactions in surrounding tissues while maintaining the biocompatibility benefits of the zinc substrate.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The corrosion of zinc that originally produced harmful free zinc ions is transformed into a beneficial process. The zinc complexing agents in the coating layer capture these zinc ions, converting the harmful corrosion byproduct into a stable zinc-complex that no longer causes sensitization reactions. The degradation products are thus converted from harmful to beneficial or neutral.

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

2Object-affected harmful factors

If zinc complexing agents are added to reduce free zinc ions, then sensitization reactions are reduced, but device complexity increases

Engineering Contradiction:
Improvesensitization reactionVSAvoiddevice complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The coating layer is formulated as a composite material comprising a polymer matrix combined with zinc complexing agents. This composite structure integrates multiple functions: the polymer provides structural integrity and biocompatibility, while the zinc complexing agents provide ion-binding capability. The composite approach allows the coating to be applied as a single integrated layer rather than multiple separate layers, thereby managing complexity.

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

Multiple protective functions are merged into a single coating layer. The polymer matrix and zinc complexing agents are combined in one coating application, providing both structural protection and chemical neutralization of zinc ions simultaneously. This merging reduces the number of separate components and processing steps compared to using multiple separate layers or treatments.

Inventive Principle:
Principle #5Merging (Combining)

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 use of zinc complexing agents and anti-allergic drugs significantly reduces the risk of sensitization reactions in tissues, addressing the long-standing issue of safety hazards associated with zinc-containing implants by controlling the release of zinc ions and preventing tissue irritation.

Implementation Method 1

The zinc complexing agent and the pure zinc or zinc alloy in the device substrate form a complex in body fluid

Methodology Applied
Scientific EffectComplex formation: Chemical Bonding

Data Source

PatentEP3400969B1Implanted device
Publication Date: 2021.05.19 BIOTYX MEDICAL (SHENZHEN) CO LTD
  • EP3400969B1 patent drawingFigure 1~3
  • EP3400969B1 patent drawingFigure 4~6
  • EP3400969B1 patent drawingFigure 7~9

AI summary

Disclosed is an implantable device, comprising a device base body and an active drug, wherein the device base body is pure zinc and/or a zinc alloy, the zinc content in the device base body is 0.1-100%, and the active drug comprises anti-allergic drugs. After the implantation of the implantable device into the human body, the surrounding tissues of the implant would not have a clear hypersensitive reaction due to the presence of the anti-allergic drugs, and the implanted device can be used to be implanted into the body for supporting organ chambers, to fill the hollow chambers of the organs and tissues or as orthopaedic implants etc.