Iron Lumen Stent Preform Microstructure for Plasma Nitriding

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Solution Overview

Problem

Current nitriding methods for iron-based stents face challenges such as low production efficiency, toxicity risks, and unsuitable mechanical properties for certain applications, particularly in achieving the required balance of radial strength and plasticity for coronary and peripheral stents.

Innovation Solution

A lumen stent preform made of pure iron or iron alloy with specific impurity and alloy content, processed to achieve a hardness of 160-250HV0.05/10 and a deformed microstructure, suitable for plasma nitriding, which enhances radial strength and corrosion rate while maintaining plasticity, using a method that includes drawing and plasma nitriding within a controlled temperature range.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Strength

If gas nitriding method is used to improve stent strength, then stent hardness increases, but production efficiency becomes too low for large-scale use

Engineering Contradiction:
Improvestent hardnessVSAvoidproduction efficiency
Core Design Contradiction:
StrengthVSProductivity

Solution Approach 1:

The patent replaces gas nitriding (chemical diffusion process) with plasma nitriding (physical plasma process), achieving faster nitrogen penetration into the iron alloy surface while maintaining improved hardness and strength

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the nitriding process parameters by using plasma state nitrogen at controlled temperatures (200-500°C) and pressures, enabling shorter treatment times compared to conventional gas nitriding while achieving the required surface hardness

Inventive Principle:
Principle #35Parameter changes

2Strength

If salt-bath nitriding method is used to improve stent strength, then stent hardness increases, but toxic molten cyanide salts are required causing high clinical risk

Engineering Contradiction:
Improvestent hardnessVSAvoidtoxicity risk
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The patent eliminates the harmful cyanide salts by using plasma nitriding with nitrogen and hydrogen gases, converting a toxic chemical process into a safe physical plasma process that leaves no toxic residues on the implantable stent

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

Solution Approach 2:

The patent uses an inert or controlled plasma atmosphere (nitrogen-hydrogen mixture) instead of toxic molten salts, creating a safe processing environment that prevents contamination of the medical device with harmful substances

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

3Strength

If gas nitriding or salt-bath nitriding is used, then stent strength improves, but compound layers become very thick (≥0.01 mm) unfavorable for subsequent polishing and fine structure design

Engineering Contradiction:
Improvestent hardnessVSAvoidsurface finish quality
Core Design Contradiction:
StrengthVSManufacturing precision

Solution Approach 1:

The patent applies plasma nitriding with controlled parameters to achieve partial nitriding - forming a thin compound layer (much thinner than 0.01 mm) that provides sufficient surface hardness while leaving the bulk material properties intact and the surface suitable for fine polishing and complex structure fabrication

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent controls the plasma nitriding parameters (temperature, pressure, gas composition, treatment time) to precisely control the thickness and composition of the compound layer, achieving optimal balance between surface hardness and surface quality for subsequent manufacturing steps

Inventive Principle:
Principle #35Parameter changes

4Reliability

If pure iron stent is used to ensure biocompatibility, then corrosion rate is slow, but mechanical properties are lower compared to stainless steel or cobalt chromium stents

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidmechanical property
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent creates a composite structure with a pure iron or iron alloy base material (providing biocompatibility and controlled corrosion) combined with a plasma-nitrided surface layer (providing enhanced hardness and strength), achieving both biocompatibility and improved mechanical properties

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent applies plasma nitriding to create local quality enhancement - the bulk material remains soft and biocompatible pure iron/iron alloy, while the surface layer gains high hardness and strength through nitrogen penetration, providing different properties where needed

Inventive Principle:
Principle #3Local quality

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 provides a stent with improved radial strength and corrosion rate, meeting the mechanical property requirements of conventional lumen stents, and allows for commercial-scale production of stents with enhanced mechanical properties.

Implementation Method 1

The plasma nitriding method has high nitriding efficiency, which uses nitrogen and hydrogen as treatment gas

Methodology Applied
Scientific EffectPlasma nitriding: Plasma

Implementation Method 2

the nitriding treatment on pure iron/iron alloys can, on one hand, improve the stent strength (characterized by hardness or radial strength)

Methodology Applied
Scientific EffectNitriding: Nitriding

Implementation Method 3

the lumen stent preform has a hardness of 160-250HV0.05/10, and has a microstructure that is a deformed structure having a grain size number greater than or equal to 9 or a deformed structure after cold machining

Methodology Applied
Scientific EffectCold deformation: Cold-forming

Data Source

PatentUS11389308B2Lumen stent and preform thereof, and methods for preparing lumen stent and preform thereof
Publication Date: 2022.07.19 BIOTYX MEDICAL (SHENZHEN) CO LTD
  • US11389308B2 patent drawing
  • US11389308B2 patent drawing
  • US11389308B2 patent drawing

AI summary

A lumen stent preform is provided using a plasma nitriding technology, a preparation method thereof, a method for preparing a lumen stent by using the preform, and a lumen stent obtained according to the method. The preform is manufactured by using pure iron or an iron alloy containing no strong nitrogen compound, has a hardness of 160-250HV0.05/10, and has a microstructure that is a deformed structure having a grain size number greater than or equal to 9 or a deformed structure after cold machining. Alternatively, the preform is an iron alloy containing a strong nitrogen compound, and has a microstructure that is a deformed structure having a grain size number greater than or equal to 9 or a deformed structure after cold machining. The lumen stent preform meets the requirements of a conventional stent for radial strength and plasticity, so that plasma nitriding is applicable to commercial preparation of a lumen stent.