Magnesium Alloy Vascular Scaffold with Polymer Coating for Rapid Resorption

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Solution Overview

Problem

Current vascular supports, particularly those made of plastic and permanent metals, face issues such as high wall thickness, poor vessel adaptation, long degradation times, and a high risk of thrombosis, especially in short-term applications like treating vulnerable plaques and aneurysms, where rapid biodegradability and residue-free dissolution are needed.

Innovation Solution

A biodegradable vascular support made of a magnesium alloy with varying Zn and Ca content, which can be fully degraded within less than 360 days, preferably less than 180 or 90 days, and coated with a polymer to control degradation and mechanical integrity, reducing the risk of thrombosis and foreign object complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If permanent or slowly degradable vascular supports are used, then mechanical stability is maintained, but long-term thrombosis risk and medication requirements increase

Engineering Contradiction:
Improvemechanical stabilityVSAvoidthrombosis risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent changes the material composition parameters by using a magnesium alloy with specific zinc content (5-25.5 wt%) and controlled wall thickness (10-50 µm), transforming the degradation time parameter from years to months, thereby reducing long-term thrombosis risk while maintaining initial mechanical stability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent applies the disposable principle by designing a vascular support that degrades completely within a short period (3-12 months) after serving its mechanical function, eliminating the need for permanent implantation and associated long-term medication, thus reducing long-term harmful effects

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

2Object-affected harmful factors

If biodegradable vascular supports with thin walls are used, then thrombosis risk is reduced, but mechanical integrity and radial force are compromised

Engineering Contradiction:
Improvethrombosis riskVSAvoidradial force
Core Design Contradiction:
Object-affected harmful factorsVSStrength

Solution Approach 1:

The patent uses a composite material system consisting of a magnesium alloy base material enhanced with zinc (5-25.5 wt%) to achieve both thin wall construction (10-50 µm) and sufficient mechanical strength, resolving the contradiction between reduced thrombosis risk and maintained radial force

Inventive Principle:
Principle #40Composite materials

3Duration of action of stationary object

If vascular supports with long degradation times are used, then mechanical support is maintained, but the implant remains as a thrombosis risk factor for extended periods

Engineering Contradiction:
Improvedegradation timeVSAvoidthrombosis risk
Core Design Contradiction:
Duration of action of stationary objectVSObject-affected harmful factors

Solution Approach 1:

The patent applies dynamics by designing a time-dependent mechanical property profile where the vascular support provides full mechanical strength initially, then progressively degrades over a controlled period (3-12 months), dynamically adapting to the healing process and eliminating long-term foreign body presence

Inventive Principle:
Principle #15Dynamics

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 allows for rapid and complete biodegradation of the vascular support, minimizing the duration of thrombocyte aggregation inhibitor therapy, reducing hemorrhage risk, and avoiding long-term complications, while maintaining mechanical stability until degradation, thus addressing the limitations of existing implants.

Implementation Method 1

the implant can be fully biodegraded within a time period of less than 360 days

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Implementation Method 2

a magnesium alloy degradable under physiological conditions

Methodology Applied
Scientific EffectCorrosion: Crevice Corrosion

Implementation Method 3

an outer polymeric coating that allows to control the degradation of the stent

Methodology Applied
Scientific EffectBarrier protection: Coatings

Implementation Method 4

disrupts the flow into the arising cavity which maintains this aneurysm from a fluid point of view

Methodology Applied
Scientific EffectFlow disruption: Fluid Spray

Data Source

PatentEP4284458B1Rapidly resorbable intravascular implant
Publication Date: 2024.10.23 BIOTRONIK AG

AI summary

The invention relates to an implant in the form of a vascular support. Such a vascular support is also referred to as a scaffold and is generally designed as a circumferential structure made of struts that are connected to one another and form the cells of the scaffold.