CN110241380B - Treatment process of medical nickel-free stainless steel - Google Patents
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/02—Inorganic materials
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- C21—METALLURGY OF IRON
- C21D—MODIFYING THE PHYSICAL STRUCTURE OF FERROUS METALS; GENERAL DEVICES FOR HEAT TREATMENT OF FERROUS OR NON-FERROUS METALS OR ALLOYS; MAKING METAL MALLEABLE, e.g. BY DECARBURISATION OR TEMPERING
- C21D1/00—General methods or devices for heat treatment, e.g. annealing, hardening, quenching or tempering
- C21D1/18—Hardening; Quenching with or without subsequent tempering
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
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- C22C38/00—Ferrous alloys, e.g. steel alloys
- C22C38/008—Ferrous alloys, e.g. steel alloys containing tin
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- C22C38/18—Ferrous alloys, e.g. steel alloys containing chromium
- C22C38/20—Ferrous alloys, e.g. steel alloys containing chromium with copper
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- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
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- C22C38/00—Ferrous alloys, e.g. steel alloys
- C22C38/18—Ferrous alloys, e.g. steel alloys containing chromium
- C22C38/24—Ferrous alloys, e.g. steel alloys containing chromium with vanadium
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
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- C22C38/00—Ferrous alloys, e.g. steel alloys
- C22C38/18—Ferrous alloys, e.g. steel alloys containing chromium
- C22C38/38—Ferrous alloys, e.g. steel alloys containing chromium with more than 1.5% by weight of manganese
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- C—CHEMISTRY; METALLURGY
- C23—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; CHEMICAL SURFACE TREATMENT; DIFFUSION TREATMENT OF METALLIC MATERIAL; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL; INHIBITING CORROSION OF METALLIC MATERIAL OR INCRUSTATION IN GENERAL
- C23C—COATING METALLIC MATERIAL; COATING MATERIAL WITH METALLIC MATERIAL; SURFACE TREATMENT OF METALLIC MATERIAL BY DIFFUSION INTO THE SURFACE, BY CHEMICAL CONVERSION OR SUBSTITUTION; COATING BY VACUUM EVAPORATION, BY SPUTTERING, BY ION IMPLANTATION OR BY CHEMICAL VAPOUR DEPOSITION, IN GENERAL
- C23C8/00—Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals
- C23C8/06—Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases
- C23C8/36—Solid state diffusion of only non-metal elements into metallic material surfaces; Chemical surface treatment of metallic material by reaction of the surface with a reactive gas, leaving reaction products of surface material in the coating, e.g. conversion coatings, passivation of metals using gases using ionised gases, e.g. ionitriding
- C23C8/38—Treatment of ferrous surfaces
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Abstract
The invention relates to a treatment process of medical nickel-free stainless steel, which improves the preparation process of medical stainless steel in the prior art, adopts the heat treatment steps of quenching and tempering after sectional heating, and adopts the nitriding surface treatment process, and ensures the surface coating performance of a stainless steel product by strictly controlling the parameter ranges of the heat treatment schedule and the surface modification, so that the stainless steel product has the use requirements of mechanical property and corrosion resistance, and simultaneously obtains excellent biocompatibility, and can meet the application requirements of medical surgical implanted metal materials.
Description
Technical Field
The invention relates to the field of metal heat treatment, in particular to a treatment process of medical nickel-free stainless steel.
Background
Biomedical materials are materials that are used in medical applications to implant into or engage with biological tissues, and are used in diagnostic treatments and to replace or enhance the function of tissues, organs, etc. in the body of a living being. Among a plurality of biological materials, the medical metal material has higher toughness and strength and is suitable for repairing and replacing hard tissues of human bodies. The clinical medical metal materials mainly include stainless steel, cobalt-based alloys, titanium alloys and the like, and in addition, precious metals such as gold, silver, niobium, pickaxe and tantalum which are pure metals, shape memory alloys and the like.
The medical stainless steel has good corrosion resistance and comprehensive mechanical property, and is the most widely applied material in biomedical metal materials. After the medical stainless steel is implanted into a human body, when a passivation layer or a protective layer on the surface is damaged due to corrosion, abrasion and the like, metal ions in the medical stainless steel are easily enriched in tissues near the implant, and the normal metabolism of organisms is influenced. The medical nickel-free stainless steel has excellent combination of obdurability and good corrosion resistance, and most importantly, the steel does not contain nickel element, so that sensitization and other tissue reactions caused by the precipitation of the nickel element in a human body can be avoided.
Medical stainless steel still has some defects and shortcomings in the actual clinical application. The strength and the elastoplasticity of the existing medical stainless steel material have certain difference with the mechanical property requirements of human skeletal tissues, and after the material is implanted into a human body, the corrosion resistance and the service life of the stainless steel can be reduced in a long-term high-stress anaerobic application environment. Therefore, there is an urgent need to research and develop a new treatment process for medical stainless steel, and to improve and improve the shortcomings of the treatment process in clinical application.
Disclosure of Invention
In order to solve the technical problems, the invention provides a treatment process of medical nickel-free stainless steel, and the method can prepare medical stainless steel products with good mechanical property, corrosion resistance and biocompatibility.
A treatment process of medical nickel-free stainless steel, which comprises the following steps:
(1) and hot forging the stainless steel blank designed according to the size of the medical material product to prepare the blank, and then rolling the blank.
(2) And putting the rolled stainless steel into a furnace for heat treatment under certain tension, heating to 500-700 ℃ at a heating speed of 100-150 ℃/h, preserving heat for 1-2 h, then heating to an austenitizing temperature at a heating speed of 400-850 ℃/min, and preserving heat for 0.5-1 h.
(3) And quenching in quenching oil, cooling the stainless steel to 160-220 ℃, taking out and preserving heat for 0.5-1 h.
(4) And then heating the stainless steel to a certain temperature, tempering and preserving heat for 2-3 hours, and cooling to room temperature.
(5) And cleaning the tempered stainless steel material, putting the stainless steel material on a nitriding workbench in ion nitriding equipment, vacuumizing the equipment, and adding ammonia gas to 400-450 Pa when the equipment is vacuumized to 10 Pa.
(6) Heating the ion nitriding equipment to 480-500 ℃, keeping for 5-10 h, adjusting to 420-440 ℃, and introducing 25% N2+75% H2And (4) mixing the gases, keeping the mixed gases for 5-10 hours, and finally cooling the mixed gases to room temperature to obtain the medical nickel-free stainless steel.
The stainless steel blank comprises 0.05wt% of C, 21.0wt% of Cr, 8.0wt% of Mn, 0.50wt% of V, 0.30wt% of Sn, 0.25wt% of Cu, and the balance of Fe and inevitable impurities.
In the step (1), the rolling is cold rolling.
In the step (2), the tension can ensure that the elongation of the stainless steel is controlled to be 1.0-5.0%.
In the step (3), the austenitizing temperature is 850-880 ℃.
In the step (4), the tempering temperature is 350-380 ℃.
In the step (5), the environmental temperature of the equipment is kept at about 400 ℃ when the equipment is vacuumized.
The yield strength of the medical nickel-free stainless steel product is 550-650 MPa, the tensile strength is 950-1050 MPa, and the elongation is 52-56%.
The medical nickel-free stainless steel finished product is used for surgical implantation of metal materials.
The medical nickel-free stainless steel finished product is steel for stainless steel skeleton fixing instruments and anticoagulant stainless steel cardiovascular stents.
Compared with the prior art, the invention has the advantages that: the preparation process of the medical stainless steel in the prior art is improved, the heat treatment steps of quenching and tempering after sectional heating are adopted, the nitriding surface treatment process is adopted, the parameter range of the heat treatment system and the surface modification is strictly controlled, the surface coating performance of the stainless steel product is ensured, the stainless steel product has the use requirements of mechanical property and corrosion resistance, and meanwhile, excellent biocompatibility is obtained, and the application requirement of medical surgical implanted metal materials can be met.
Detailed Description
The standard content of nickel element in medical stainless steel is regulated in many countries including China, and the standard of medical nickel-free stainless steel is released. As a new biomedical material, nickel-free stainless steel has made an important progress in various fields because it does not contain nickel element and has excellent comprehensive properties. As a coronary stent implantation material, the nickel-free stainless steel has good blood compatibility, has a certain inhibition effect on the proliferation of vascular smooth muscle cells, and has very important significance on reducing restenosis caused after stent implantation. With the continuous and deep research and gradual optimization of the relevant basic properties such as biological safety, mechanical property and the like of the nickel-free stainless steel, the medical nickel-free stainless steel is gradually replacing the traditional medical stainless steel.
The sterilization mechanism will vary for different types of antimicrobial stainless steel. There are two main mechanisms of antibacterial action, depending on the antibacterial agent: ionic sterilization and photocatalytic sterilization. For alloy type and surface modified stainless steel plated with antibacterial metal, the main antibacterial mechanism is ionic sterilization. Taking copper-containing antibacterial stainless steel as an example, due to the inevitable corrosion effect in the service process of the antibacterial stainless steel, antibacterial ions with strong bactericidal effect can be released on the surface of the antibacterial stainless steel in a micro-scale and continuous manner. Copper ions dissolved out of the surface of the stainless steel can destroy the protein structure in the bacteria, inhibit the replication of bacterial DNA and the synthesis of related protein/enzyme, destroy the metabolic activity in the bacteria, inactivate the bacteria and cause the bacteria to die.
Surface modification is an effective method for improving the corrosion resistance and blood compatibility of medical metal materials, and the main methods thereof can be divided into two types: the method is characterized in that a biological ceramic film (or coating) with good biocompatibility is prepared on the surface of stainless steel, but the problems of low bonding strength of a substrate-film (or coating) interface and poor stability of long-term implantation in a physiological environment exist; the other is in-situ surface modification by physical or chemical methods, such as mechanical polishing, particle beam implantation, laser modification, surface chemical treatment, and surface thermal treatment, which can change the composition and structure of the material surface while preserving the properties of the metal material itself. Biomedical metal materials are prone to wear and corrosion, and therefore the biocompatibility of the medical materials can be improved by utilizing a surface modification technology. Especially for the surface modification of hard tissue implants such as bones, teeth and the like and cardiovascular metal stents, the corrosion resistance and the blood compatibility of the implants can be improved.
The preparation process of the medical nickel-free stainless steel material completely abandons nickel element, adopts nitrogen element to strengthen austenite matrix, and ensures that the stainless steel has a single and stable microscopic grain structure by proper heat treatment, and can still maintain a stable structure even after severe deformation. In addition, the stainless steel product has excellent corrosion resistance in 0.9wt% NaCl physiological saline and simulated plasma solution, and the elongation and the reduction of area are kept at high levels while the strength is improved.
The present invention will be described in further detail with reference to examples and comparative examples.
Example 1:
a treatment process of medical nickel-free stainless steel, which comprises the following steps:
(1) and hot forging the stainless steel blank designed according to the size of the medical material product to prepare the blank, and then rolling the blank.
(2) And putting the cold-rolled stainless steel into a furnace for heat treatment under certain tension, wherein the tension can ensure that the elongation of the stainless steel is controlled to be 1.0 percent, heating to 550 ℃ at a heating speed of 120 ℃/h, preserving heat for 2h, then heating to 880 ℃ at a heating speed of 850 ℃/min, and preserving heat for 1 h.
(3) Quenching in quenching oil, cooling the stainless steel to 180 ℃, taking out and preserving heat for 0.5 h.
(4) Then the stainless steel is heated to 360 ℃, tempered and insulated for 2 hours, and cooled to room temperature.
(5) Cleaning the tempered stainless steel material, putting the stainless steel material on a nitriding workbench in ion nitriding equipment, vacuumizing the equipment, keeping the environmental temperature of the equipment at about 400 ℃, and adding ammonia gas to 410Pa when the equipment is vacuumized to 10 Pa.
(6) Heating the ion nitriding equipment to 480 ℃ for 10 hours, adjusting the temperature to 420 ℃, and introducing 25% N2+75% H2Mixing the gases, keeping the mixture for 8 hours, and finally cooling the mixture to room temperature to obtain the medical nickel-free stainless steel.
The stainless steel blank comprises 0.05wt% of C, 21.0wt% of Cr, 8.0wt% of Mn, 0.50wt% of V, 0.30wt% of Sn, 0.25wt% of Cu, and the balance of Fe and inevitable impurities.
The yield strength of the medical nickel-free stainless steel product is 550MPa, the tensile strength is 950MPa, and the elongation is 56%.
The medical nickel-free stainless steel finished product is used for surgical implantation of metal materials.
Example 2:
a treatment process of medical nickel-free stainless steel, which comprises the following steps:
(1) and hot forging the stainless steel blank designed according to the size of the medical material product to prepare the blank, and then rolling the blank.
(2) And putting the cold-rolled stainless steel into a furnace for heat treatment under certain tension, wherein the tension can ensure that the elongation of the stainless steel is controlled to be 4.0 percent, heating to 600 ℃ at a heating speed of 150 ℃/h, preserving heat for 2h, then heating to 860 ℃ at a heating speed of 450 ℃/min, and preserving heat for 0.5 h.
(3) Quenching treatment is carried out in quenching oil, and the stainless steel is taken out after being cooled to 190 ℃ and kept warm for 0.5 h.
(4) Then the stainless steel is heated to 380 ℃, tempered and insulated for 3 hours, and cooled to room temperature.
(5) Cleaning the tempered stainless steel material, putting the stainless steel material on a nitriding workbench in ion nitriding equipment, vacuumizing the equipment, keeping the environmental temperature of the equipment at about 400 ℃, and adding ammonia gas to 420Pa when the equipment is vacuumized to 10 Pa.
(6) Heating the ion nitriding equipment to 500 ℃ for 6h, adjusting the temperature to 420 ℃, and introducing 25% N2+75% H2Mixing the gases, keeping the mixture for 5 hours, and finally cooling the mixture to room temperature to obtain the medical nickel-free stainless steel.
The stainless steel blank comprises 0.05wt% of C, 21.0wt% of Cr, 8.0wt% of Mn, 0.50wt% of V, 0.30wt% of Sn, 0.25wt% of Cu, and the balance of Fe and inevitable impurities.
The yield strength of the medical nickel-free stainless steel product is 600MPa, the tensile strength is 1000MPa, and the elongation is 55%.
The finished product of the medical nickel-free stainless steel is steel for products of stainless steel skeleton fixed instruments.
Example 3:
a treatment process of medical nickel-free stainless steel, which comprises the following steps:
(1) and hot forging the stainless steel blank designed according to the size of the medical material product to prepare the blank, and then rolling the blank.
(2) And putting the cold-rolled stainless steel into a furnace for heat treatment under certain tension, wherein the tension can ensure that the elongation of the stainless steel is controlled to be 3.5 percent, heating to 700 ℃ at a heating speed of 130 ℃/h, preserving heat for 1.5h, then heating to 850 ℃ at a heating speed of 650 ℃/min, and preserving heat for 0.5 h.
(3) Quenching treatment is carried out in quenching oil, and the stainless steel is taken out and kept warm for 1h after being cooled to 160 ℃.
(4) Then the stainless steel is heated to 380 ℃, tempered and insulated for 3 hours, and cooled to room temperature.
(5) Cleaning the tempered stainless steel material, putting the stainless steel material on a nitriding workbench in ion nitriding equipment, vacuumizing the equipment, keeping the environmental temperature of the equipment at about 400 ℃, and adding ammonia gas to 450Pa when the vacuum degree is 10 Pa.
(6) Heating the ion nitriding equipment to 490 ℃ for 10h, adjusting the temperature to 440 ℃, and introducing 25% N2+75% H2Mixing the gases, keeping the mixture for 6 hours, and finally cooling the mixture to room temperature to obtain the medical nickel-free stainless steel.
The stainless steel blank comprises 0.05wt% of C, 21.0wt% of Cr, 8.0wt% of Mn, 0.50wt% of V, 0.30wt% of Sn, 0.25wt% of Cu, and the balance of Fe and inevitable impurities.
The yield strength of the finished medical nickel-free stainless steel material is 650MPa, the tensile strength is 1050MPa, and the elongation is 52%.
The finished product of the medical nickel-free stainless steel is the steel for the anticoagulant stainless steel cardiovascular stent.
Comparative example 1:
when the heat treatment process schedule is changed, the microstructure of the stainless steel is changed. For example, if the heating system is not performed in stages, the stainless steel has cold rolling residual stress, and the austenite stage has coarse grains and local uneven components. The element proportion of the invention is the comprehensive performance of balanced mechanical property and corrosion resistance and biocompatibility considered, when the element types or contents are changed, the mechanical property, biological allergenicity and cytotoxicity of the final stainless steel product are deteriorated, and simultaneously, the heat treatment system is not adapted to the mechanical property, biological allergenicity and cytotoxicity, and the excellent comprehensive performance can not be obtained.
Comparative example 2:
in the manufacturing method of the invention, when the surface treatment process is changed, especially the process parameters such as nitriding atmosphere, temperature and the like are changed, the surface treatment effect is influenced, the coating quality of the final product of the medical stainless steel is poor, and the service life is shortened under the high-stress high-corrosion environment in a human body.
As can be seen from examples 1-3 and comparative examples 1 and 2, the experimental results show that: the invention improves the preparation process of the medical stainless steel in the prior art, adopts the heat treatment steps of quenching and tempering after sectional heating, adopts the nitriding surface treatment process, and ensures the surface coating performance of the stainless steel product by strictly controlling the heat treatment system and the parameter range of surface modification, so that the stainless steel product has the use requirements of mechanical property and corrosion resistance, and simultaneously obtains excellent biocompatibility, and can meet the application requirements of medical surgical implanted metal materials.
While embodiments of the invention have been shown and described, it will be understood by those of ordinary skill in the art that: various changes, modifications, substitutions and alterations can be made to the embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.
Claims (8)
1. A treatment process of medical nickel-free stainless steel is characterized by comprising the following steps:
(1) hot forging is carried out according to the size of a stainless steel blank designed by a medical material product to prepare the blank, and then the blank is rolled;
(2) putting the rolled stainless steel into a furnace for heat treatment under certain tension, wherein the tension can ensure that the elongation of the stainless steel is controlled to be 1.0-5.0%, and the heat treatment comprises the steps of firstly heating to 500-700 ℃ at a heating speed of 100-150 ℃/h, preserving heat for 1-2 h, then heating to an austenitizing temperature at a heating speed of 400-850 ℃/min, and preserving heat for 0.5-1 h;
(3) quenching in quenching oil, cooling the stainless steel to 160-220 ℃, taking out and preserving heat for 0.5-1 h;
(4) then heating the stainless steel to a certain temperature, tempering and preserving heat for 2-3 hours, and cooling to room temperature;
(5) cleaning the tempered stainless steel material, putting the stainless steel material on a nitriding workbench in ion nitriding equipment, vacuumizing the equipment, and adding ammonia gas to 400-450 Pa when the equipment is vacuumized to 10 Pa;
(6) heating the ion nitriding equipment to 480-500 ℃, keeping for 5-10 h, adjusting to 420-440 ℃, and introducing 25% N2+75% H2Keeping the mixed gas for 5-10 hours, and finally cooling to room temperature to obtain medical nickel-free stainless steel;
the stainless steel blank comprises 0.05wt% of C, 21.0wt% of Cr, 8.0wt% of Mn, 0.50wt% of V, 0.30wt% of Sn, 0.25wt% of Cu, and the balance of Fe and inevitable impurities.
2. The process of claim 1, wherein in step (1), the rolling is cold rolling.
3. The treatment process according to claim 1, wherein in the step (3), the austenitizing temperature is 850 to 880 ℃.
4. The treatment process according to claim 1, wherein in the step (4), the tempering temperature is 350-380 ℃.
5. The process of claim 1, wherein in step (5), the ambient temperature of the apparatus is maintained at about 400 ℃ while the apparatus is evacuated.
6. The treatment process according to claim 1, wherein the medical nickel-free stainless steel material has a yield strength of 550 to 650MPa, a tensile strength of 950 to 1050MPa, and an elongation of 52 to 56%.
7. The process according to claim 1, wherein the medical nickel-free stainless steel material is used for surgical implantation of metallic materials.
8. The process according to claim 7, wherein the medical nickel-free stainless steel material is steel for products of stainless steel bone fixation instruments and anticoagulant stainless steel cardiovascular stents.
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| EP4144387A1 (en) * | 2020-04-30 | 2023-03-08 | Zhong Ke Yi An Medical Technology (Beijing) Co., Ltd | High-nitrogen nickel-free austenitic stainless steel seamless thin-walled tube |
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