CN103233174B - High-nitrogen austenitic stainless steel for vascular stent and application thereof - Google Patents
High-nitrogen austenitic stainless steel for vascular stent and application thereof Download PDFInfo
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- 229910000963 austenitic stainless steel Inorganic materials 0.000 title claims abstract description 43
- 230000002792 vascular Effects 0.000 title abstract description 9
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- 239000010935 stainless steel Substances 0.000 claims abstract description 64
- PXHVJJICTQNCMI-UHFFFAOYSA-N nickel Substances [Ni] PXHVJJICTQNCMI-UHFFFAOYSA-N 0.000 claims abstract description 38
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- Materials For Medical Uses (AREA)
Abstract
The invention provides a high-nitrogen austenitic stainless steel material for a vascular stent, which comprises the following chemical components in percentage by weight: 16-20% of Cr, 12-20% of Mn, 1-3% of Mo, 0.5-2% of Cu, no more than 0.05% of Ni, 0.7-1.2% of N, 0.5-8% of W, 0.05-0.5% of RE, no more than 0.08% of C, 0.3-4% of Si, no more than 0.010% of S, no more than 0.02% of P and the balance of Fe, wherein RE is a rare-earth element. The high-nitrogen stainless steel provided by the invention is mainly used for vascular stent processing; the elements of copper, nitrogen and rare earth are added to increase the blood compatibility of the stainless steel; and the tungsten alloy is added to increase the density of the stainless steel. The stainless steel has excellent visibility under X rays, contains no potential toxic element nickel, can be used in the aspects of surgical implants, medical appliances, food and catering appliances, jewelry and other stainless steel products which are always in contact with a human body, and can also be used in the fields of chemical engineering, environment protection and the like.
Description
Technical field
The invention belongs to alloy field, a kind of intravascular stent high-nitrogen austenitic stainless steel is provided especially.
Background technology
Atherosclerosis is the common disease threatening human health in recent years, and intracoronary stent operation is the very important method of one of coronary atherosclerotic heart disease patient revascularization.Nowadays the problem of coronary Artery In-stent Restenosis is along with bracket for eluting medicament (drug-eluting stents, DES) appearance is improved significantly, but bracket for eluting medicament medium-long term thrombus in stents that is complete due to vessel endothelialisation or that postpone to cause likely increases the occurrence probability of in-stent restenosis again.Generally believe at present, In-stent Restenosis is mainly caused by the tunica intima migration of inducing smooth muscle cell after being subject to the mechanical stimulus of support and hyper-proliferative.Although bracket for eluting medicament improves by medicine and has postponed intimal hyperplasia, reduce postoperative restenosis rate, but rack surface drug release after poppet grid is to the mechanical stimulus sustainable existence of endothelial tissue, and residual macromolecular material and this stimulation may be strengthened from the metal ion (as nickel, manganese, molybdenum etc.) of backbone metal self-corrosion stripping.Therefore reduce or reduce support is the major issue that support manufacturer and clinician are concerned about to the stimulation of internal film tissue always.Therefore Development of Novel support material, reduce or remove and wherein internal film tissue's spinosity is swashed or the metallic element of the side effect such as irritated, the alloy element simultaneously adding useful vascular tissue, to improve its biocompatibility, fundamentally can reduce the stimulation of timbering material to tunica intima tissue.The support of the meticulous twine of the alloy of current employing high strength or stainless steel processing is applied in clinical acquisition, and show excellent performance, twine size is on average at 70 μm, but it is poor that the problem that fine-structure mesh silk support brings is exactly the visuality of support under X-ray, so the density improving timbering material is most important.
The research and development that medical high-nitrogen nickel-free stainless steel have passed through nearly 20 years, 2 kinds of Srgery grafting high nitrogen and nickel-less austenitic stainless steels have been had to list (ASTMF2229-02 in U.S. ASTM standard of materials at present, F2581-07), and start to be applied to clinical, mainly field of orthopaedics.Metal Inst., Chinese Academy of Sciences takes the lead in having carried out the research that nitrogen strengthens austenite nickelles stainless steel at home; granted patent is " a kind of medical embedded austenitic stainless steel material " (patent No.: 03110896.2); the medical free nickel austenitic stainless steel nitrogen content protected is in 0.4% ~ 0.7% (mass content); but its stabilization of austenite is poor, and its density only 7.7kgm
-3, the visuality be processed into after fine-structure mesh silk support is poor.Therefore the research and development of the high-nitrogen austenitic stainless steel of the special high-density high-strength for intravascular stent processing use are imperative.
Summary of the invention
For above problem, the invention provides a kind of intravascular stent high-nitrogen austenitic stainless steel material with good visibility under excellent blood compatibility and X-ray, this material adds and usually improves stainless blood compatibility to the useful rare earth RE element of vascular tissue, element silicon, copper and nitrogen unit on the stainless basis of existing high-nitrogen nickel-free, add high density tungsten element simultaneously and improve stainless density to increase the visuality of stainless steel under X-ray, and not containing toxicity nickel element.
The present invention specifically provides a kind of intravascular stent high-nitrogen austenitic stainless steel, it is characterized in that: its chemical composition of described stainless steel composition and weight percent are: chromium Cr:16 ~ 20%, manganese Mn:12 ~ 20%, molybdenum Mo:1 ~ 3%, copper Cu:0.5 ~ 2%, nickel≤0.05%, nitrogen N:0.7 ~ 1.2%, tungsten W:0.5 ~ 8%, RE:0.05-0.5%, carbon C≤0.08%, silicon Si:0.3 ~ 4%, sulphur S≤0.010%, phosphorus P≤0.02%, iron Fe: surplus; Wherein RE is rare earth element.Be preferably chromium Cr:16 ~ 18%, manganese Mn:14 ~ 16%, molybdenum Mo:1 ~ 2%, copper Cu:0.75 ~ 1.5%, nickel≤0.05%, nitrogen N:0.8 ~ 1.0%, tungsten W:2 ~ 4%, RE:0.05-0.2%, carbon C≤0.03%, silicon Si:0.5 ~ 2%, sulphur S≤0.010%, phosphorus P≤0.02%, iron Fe: surplus.
In free nickel high nitrogen austenitic stainless steel provided by the present invention, in order to avoid potential sensitization and the harm such as carcinogenic of nickel element, consider the residual content of nickel in metallurgical raw material, in high-nitrogen austenitic stainless steel of the present invention, control nickel≤0.05%.
Free nickel high nitrogen austenitic stainless steel provided by the present invention, in order to ensure excellent mechanical property and corrosion resisting property, particularly cold-forming property, the strict carbon content controlled in alloy, in high-nitrogen austenitic stainless steel of the present invention, carbon content preferably controls at C≤0.08%.
High-nitrogen austenitic stainless steel provided by the present invention contains nitrogen element, and first nitrogen is the alloying element of stable austenite tissue, and the austenitizing ability of nitrogen is approximately 20-30 times of nickel.For ensureing the single stable austenitic structure of steel, excellent mechanical property and high solidity to corrosion, nitrogen content should control more than 0.7%, and the nitrogen element secondly in alloy is macroelement in human body, and the NH that corrosion process is formed
4 +or NH
3, a small amount of NH
3or NH
4 +can be hydrolyzed and form local weakly alkaline environment and improve its biocompatibility and blood compatibility.According to chemical reaction
nitrogen-atoms and water reaction are except generating NH
3outward, NO can also be generated, and NO and cardiovascular disorder in close relations, NO can promote vasorelaxation, prevent the formation and development of atherosclerotic plaque and sclerosis, NO also can suppress hematoblastic activation and gathering, and be called as endogenous platelet aggregation and adherence inhibition thing, its mechanism of action is similar to vasodilative effect.Nitrogen content higher in the present invention contributes to stainless steel surface passivation layer in slow corrosion process, forms NO or NH
3the biocompatibility at implant position is improved on nitride.But nitrogen too much in alloy affects the cold and hot working performance of alloy, therefore consider metallurgy factor and the impact on cold-workability and cold shaping performance, in high-nitrogen austenitic stainless steel of the present invention, Control of Nitrogen Content is 0.7 ~ 1.2%.
High-nitrogen austenitic stainless steel provided by the present invention contains chromium element, and in biomedicine, chromium is a kind of required trace element.Trivalent chromium is needed by human, has important trophism, needs chromium to participate in when Regular Insulin plays a role.Chromium participates in the metabolism regulating metabolism of lipid and cholesterol, and the chromium of trace can harden by prevention of arterial, recovers vessel wall elasticity.Chromium is that high nitrogen stainless steel has the topmost alloying element of solidity to corrosion simultaneously, and in oxidizing medium, chromium can make alloy surface to generate rapidly chromic oxide (such as Cr
2o
3) passive film, improve stainless solidity to corrosion.Due to the anti-corrosion element that chromium is main in stainless steel, and improve the solubleness of nitrogen in alloy, consider that chromium is ferrite former, in high-nitrogen austenitic stainless steel of the present invention, chromium content controls 16 ~ 20%.
High-nitrogen austenitic stainless steel provided by the present invention contains manganese element, first the manganese in alloy is the trace element of needed by human, manganese all has important effect in animals and plants and human body, it is the cofactor of enzyme, can promote that VITAMIN is synthesized, manganese participates in the anabolism of protein, can also activate archaeal dna polymerase etc.Mn ion can also by with the acceptor on Ni ion competition target cell (as natural killer cell NKC), suppress the absorption of sensitization Ni ion, thus the ubcellular changed caused by nickel ion is destroyed.Secondly the manganese element in alloy is austenite former, has the effect of strongly stablizing high nitrogen stainless steel austenitic matrix.In stainless steel of the present invention, another important effect of manganese element is the solubleness increasing nitrogen in steel, and consider the nitrogen content in alloy, in high-nitrogen austenitic stainless steel of the present invention, Fe content controls 12 ~ 20%.
High-nitrogen austenitic stainless steel provided by the present invention contains molybdenum element, and first as Srgery grafting alloy, the molybdenum in steel is also a kind of important micro elements needed by human simultaneously, and molybdenum element has special provide protection to the cardiovascular of human body.Secondly molybdenum adds in high nitrogen stainless steel the solidity to corrosion particularly performance such as resistance to spot corrosion and crevice corrosion being mainly used to improve steel.Consider that molybdenum is ferrite former, in high-nitrogen austenitic stainless steel of the present invention, molybdenum content controls 1 ~ 3%.
High-nitrogen austenitic stainless steel provided by the present invention contains copper, and first copper is more weak austenizer, also suitably improves solidity to corrosion.Secondly copper is a kind of important micro elements needed by human, and copper is the important component forming layout of a page without columns albumen, participates in the metabolism of iron and anti-oxidant.And copper has important effect to cardiovascular systems, the formation of copper to reticular tissue main in heart and artery is absolutely necessary, and copper is the integral part making heart and the whippy fibrous matter of arterial wall and elastin form enzyme.Cupric ion also has certain broad-spectrum antimicrobial function simultaneously, a small amount of copper can also improve stainless solidity to corrosion and cold forming capability, copper can form sosoloid with nickel and exist in nickel austenite stainless steel, but shortage and copper form the alloying element of sosoloid in high-nitrogen nickel-free stainless steel, the solubleness of copper is limited, have a strong impact on its hot workability, if consider, in high-nitrogen nickel-free stainless steel, copper content obviously will affect the forging property of steel higher than 2%, thus in high-nitrogen austenitic stainless steel of the present invention copper content control 0.5 ~ 2%.
High-nitrogen austenitic stainless steel provided by the present invention contains rare earth element, and first rare earth can play cleaning molten steel in stainless smelting, reduces and change the effects such as the shape of inclusion.Secondly rare earth is also a kind of important trace element, and rare earth has been widely used in the aspects such as treatment burn, inflammation, tetter and thrombus disease, and rare earth element shows anticoagulation, the advantage such as anti-inflammation and sterilization and arteriosclerosis.In order to reduce mishmetal to the stainless not clear impact of the present invention, high nitrogen stainless steel rare earth elements of the present invention is based on lanthanum element (>=90%), consider that a large amount of rare earth element affects stainless mechanical property, high-nitrogen austenitic stainless steel Rare-Earth Content of the present invention controls 0.05 ~ 0.5%.
High-nitrogen austenitic stainless steel provided by the present invention contains W elements, tungsten is also ferrite former in stainless steel, its effect and Mo similar, stainless corrosion resisting property can be improved, in the present invention, tungsten adds mainly in order to improve stainless density, thus improve the visuality of stainless steel under X-ray, be conducive to the visual operation after the processing of intravascular stent fine-structure mesh silkization.Although adding tungsten, can to improve stainless steel density be that it adds 10 times of percentage composition, namely adding 6% W content can bring up to 8.4g/cm by stainless steel density
3left and right, but consider that too much W content affects stainless mechanical property, and in high-nitrogen austenitic stainless steel of the present invention, W content controls 0.5 ~ 8%.
In high-nitrogen austenitic stainless steel provided by the present invention, silicon is also a kind of useful trace element, especially has provide protection to cardiovascular, can alleviate arteriosclerosis, recovers blood vessel elasticity.Siliceous medicine already for clinical, and silicon in stainless steel usually used as impurity, part reduce stainless corrosion resisting property.Silicon adds in stainless steel in the present invention, the solution treatment proposed by the present invention, timeliness disperse process and low temperature pre-passivating treatment process, silicon is made to form rich nitrogen Silicon-rich upper layer at stainless steel surface, alleviate arteriosclerosis by the nitrogenous and silicon-containing material produced in stainless steel microcorrosion process, recover blood vessel elasticity.Consider that element silicon can impel ferritic formation and reduce solidity to corrosion, therefore in high-nitrogen austenitic stainless steel of the present invention, silicone content controls 0.3 ~ 4%.
Sulphur and phosphorus are regarded as detrimental impurity at high nitrogen stainless steel of the present invention, therefore control sulphur content in cobalt base alloy of the present invention and lower than 0.01%, should control phosphorus content below 0.02%.
Stainless steel surface passivation layer of the present invention contains the alloying elements such as chromium, silicon, copper and nitrogen, in stainless steel microcorrosion process, improve arteriosclerosis state by its corresponding ion or compound, recovers blood vessel elasticity.
Present invention also offers the preparation method of above-mentioned high nitrogen stainless steel, described stainless hot-work and thermal treatment process are:
Hot-work: steel ingot was in 1050 ~ 1200 DEG C of Homogenization Treatments 2 ~ 4 hours, and cogging, point many fire are forged into bar and breaking down blank, and final forging temperature is not less than 950 DEG C.
Thermal treatment: according to stainless steel sample size, 1100 ~ 1200 DEG C of solution treatment 0.5 ~ 4 hour, air cooling or water-cooled, to room temperature, made the compound of chromium, copper, nitrogen and silicon or are mingled with abundant solid solution, and gained microstructure is single phase austenite.
After solution treatment, also can carry out timeliness disperse process and the process of low temperature pre-passivating to stainless steel:
Timeliness disperse process: 450 ~ 600 DEG C of ageing strengthenings 0.5 ~ 4 hour, makes the compound of chromium, copper, nitrogen and silicon or other composition phase even dispersion be distributed in stainless steel inside.
Low temperature pre-passivating process: be incubated pre-passivating process 0.5 ~ 5 hour under 50 ~ 100 DEG C of atmospheric environments, makes stainless steel surface form the passivation film containing the elements such as chromium, silicon, copper, nitrogen.
High-nitrogen austenitic stainless steel of the present invention adopts the induction furnace that pressurizes to smelt or other pressurization melting equipments such as esr that pressurize are smelted, and in protective atmosphere, nitrogen pressure is 0.2MPa-1MPa, and the nitrogen in alloy passes through granular high nitrogen alloy (as FeCrN, CrN, MnN, Si
3n
4one or more) mode add, in high nitrogen alloy, nitrogen content is not less than 5%.
The tissue of implant site is acted in order to enable useful alloying element in intravascular stent nickel-less austenitic stainless steel of the present invention, improve the elasticity of blood vessel, reduce the restenosis of support, stainless steel of the present invention must implement specific thermal treatment, make wherein useful chromium, copper, nitrogen and element silicon even dispersion be distributed in stainless steel surface, inevitably slowly corrode the ion of release by the later stage or compound acts on body tissue.
Advantage of the present invention:
The relatively traditional vascular stent material of high-nitrogen austenitic medical stainless steel of the present invention, has abandoned the toxicity nickel element having sensitization, bring out thrombosis and carcinogenesis first completely.Secondly useful to vascular system in stainless steel chromium element, copper, element silicon, rare earth element and nitrogen element, it is made to be evenly distributed on stainless steel surface by specific thermal treatment, the various compound of the chromium ion, cupric ion, silicon-containing material and the nitrogen that utilize the inevitable microcorrosion of stainless steel to produce and ion etc., improve and optimize the elasticity of stainless steel stent implant site blood vessel, improve support at the biocompatibility in vascular system, reduce restenosis rate.W elements is added to improve stainless density in last stainless steel, increase its visuality under X-ray, ensure that the superfine cardiovascular and cerebrovascular support of high nitrogen stainless steel processing and fabricating of the present invention has good visuality, therefore high-nitrogen austenitic stainless steel of the present invention has great advantage as vascular stent material.
Range of application:
High-nitrogen austenitic stainless steel of the present invention is except for the preparation of except intravascular stent, also can be used for the Srgery grafting such as orthopaedics, dentistry field, medicine equipment, food food and drink apparatus, jewellery and other stainless steel product aspect often contacted with human body can also be used for, also can be applicable to the field such as chemical industry, environmental protection.
Accompanying drawing explanation
Fig. 1 is No. 5 stainless steels 1100 DEG C of solution treatment metallograph of 1 hour preferably;
Fig. 2 contrasts stainless steel 1100 DEG C of solution treatment metallograph of 1 hour (in figure visible ferrite);
Fig. 3 contrasts stainless steel and the anodic polarization curves of No. 5-1, preferred stainless steel in hank ' s simulated body fluid.
Embodiment
According to the chemical composition ranges set by high nitrogen stainless steel of the present invention, adopt 50 kilograms of pressurization induction furnaces to smelt 5 stove steel (respectively No. 1-5, numbering) and contrast each 20 kilograms of stainless steel, its specific chemical composition is as shown in table 1.Protection nitrogen pressure is respectively 0.5MPa, 0.6MPa, 1MPa and 0.8MPa; 0.7MPa; nitro-alloy is nitrogen content is 6%(wt%) MnN, this 6 stove steel is typically cast onto each one of φ 100 × 350 steel ingot respectively, processes by following processing and heat treatment process specification.
Forging process is: alloy pig is in 1150 DEG C ± 15 DEG C homogenizing thermal treatment cogging in 2 hours, and point three fire are forged into breaking down blank, and final forging temperature is 950 DEG C.
Hot rolling technology is: breaking down blank is 1150 DEG C ± 15 DEG C temperature open rollings after 2 hours, and become capability test board material through multi-pass rolling, it is thick that the present embodiment thickness of slab is 11mm.
Thermal treatment process is: test sheet material samples along perpendicular to machine direction, and cut into the test square stock of 11mm × 11mm, 1100 DEG C ± 5 DEG C solution treatment (1 ± 0.1) hour, air cooling or water-cooled are to room temperature.Wherein No. 5 alloy is preferred alloy composition, No. 5-1 and No. 5-2 is divided in implementation process, wherein only prepare according to above thermal treatment process for No. 5-1, to 5-2 alloy on this basis 500 DEG C of homogenizing ageing treatment 2 hours, make chromium in stainless steel, copper, nitrogen and element silicon even dispersion be distributed in stainless steel surface, and under 70 DEG C of atmospheric environments, carry out insulation pre-passivating process 5 hours.The chemical composition of beta alloy and comparative alloy is in table 1.All mechanical test samples all sample along perpendicular to rolling direction, and the mechanical property recorded is as shown in table 2.
The chemical composition of the high nitrogen steel of table 1 vacuum induction furnace smelting
The mechanical property of the high nitrogen steel of table 2 vacuum induction furnace smelting
From embodiment test result, obtain nitrogen content in high-nitrogen nickel-free stainless steel raising stainless steel of the present invention, and add W elements, compare original high-nitrogen nickel-free stainless steel, intensity all significantly improves, and all remains on more than 1000MPa, and density also all reaches 8.0g/cm
3above.The present invention preferred No. 5 alloy conservative control nitrogen content and W content, by ageing strengthening and low temperature pre-passivating treatment process, compare 1-4 stainless steel, have higher intensity and suitable density, also have higher plasticity and toughness simultaneously.Particularly No. 5 preferred stainless steels compare more more obvious than stainless steel advantage, and not only austenite structure is more stable, and corrosion resisting property relative contrast stainless steel significantly improves, particularly pitting resistance.See Fig. 1-3.The mechanical property simultaneously compared before and after No. 5 preferred stainless steels 500 DEG C of homogenizing ageing treatment can be known, homogenizing ageing treatment suitably can improve the stainless intensity of the present invention, and not obvious reduction plasticity and toughness (see table 2).
Above-described embodiment, only for technical conceive of the present invention and feature are described, its object is to person skilled in the art can be understood content of the present invention and implement according to this, can not limit the scope of the invention with this.All equivalences done according to spirit of the present invention change or modify, and all should be encompassed within protection scope of the present invention.
Claims (9)
1. an intravascular stent high-nitrogen austenitic stainless steel, is characterized in that: its chemical composition of described stainless steel composition and weight percent are: chromium Cr:16 ~ 20%, manganese Mn:12 ~ 20%, molybdenum Mo:1 ~ 3%, copper Cu:1.02 ~ 2%, nickel≤0.05%, nitrogen N:0.7 ~ 1.2%, tungsten W:2.2 ~ 8%, RE:0.05-0.5%, carbon C≤0.08%, silicon Si:1.25 ~ 4%, sulphur S≤0.010%, phosphorus P≤0.02%, iron Fe: surplus; Wherein RE is rare earth element.
2. according to intravascular stent high-nitrogen austenitic stainless steel described in claim 1, it is characterized in that: chromium Cr:16 ~ 18%, manganese Mn:14 ~ 16%, molybdenum Mo:1 ~ 2%, copper Cu:1.02 ~ 1.5%, nickel≤0.05%, nitrogen N:0.8 ~ 1.0%, tungsten W:2.2 ~ 4%, RE:0.05-0.2%, carbon C≤0.03%, silicon Si:1.25 ~ 2%, sulphur S≤0.010%, phosphorus P≤0.02%, iron Fe: surplus.
3. according to intravascular stent high-nitrogen austenitic stainless steel described in claim 1 or 2, it is characterized in that: lanthanum content >=90wt% in rare earth RE.
4. according to intravascular stent high-nitrogen austenitic stainless steel described in claim 1 or 2, it is characterized in that: described stainless steel surface passivation layer contains chromium, silicon, copper and nitrogen element, in stainless steel microcorrosion process, improve arteriosclerosis state by its corresponding ion or compound, recover blood vessel elasticity.
5. a preparation method for intravascular stent high-nitrogen austenitic stainless steel as claimed in claim 1 or 2, it is characterized in that, described stainless hot-work and thermal treatment process are:
Hot-work: steel ingot in 1050 ~ 1200 DEG C of Homogenization Treatments 2 ~ 4 hours, cogging, point many fire are forged into bar and breaking down blank, and final forging temperature is not less than 950 DEG C;
Thermal treatment: according to stainless steel sample size, 1100 ~ 1200 DEG C of solution treatment 0.5 ~ 4 hour, makes the compound of chromium, copper, nitrogen and silicon or is mingled with abundant solid solution;
After solution treatment, timeliness disperse process and the process of low temperature pre-passivating are carried out to stainless steel: 450 ~ 600 DEG C of ageing strengthenings 0.5 ~ 4 hour; Pre-passivating process is incubated 0.5 ~ 5 hour under 50 ~ 100 DEG C of atmospheric environments.
6. according to the preparation method of intravascular stent high-nitrogen austenitic stainless steel described in claim 5; it is characterized in that: described high-nitrogen austenitic stainless steel adopts pressurization induction furnace to smelt or other pressurization melting equipment is smelted; in protective atmosphere, nitrogen pressure is 0.2MPa-1MPa; nitrogen element in alloy is added by granular high nitrogen alloy mode; in high nitrogen alloy, nitrogen content is not less than 5%, and described high nitrogen alloy is FeCrN, CrN, MnN, Si
3n
4one or more.
7. one kind as claimed in claim 1 intravascular stent high-nitrogen austenitic stainless steel preparing the application in surgical implant, medicine equipment.
8., it is characterized in that preparing the application in surgical implant, medicine equipment according to intravascular stent high-nitrogen austenitic stainless steel described in claim 7, described surgical implant is intravascular stent.
9. one kind as claimed in claim 1 intravascular stent high-nitrogen austenitic stainless steel in the application of food food and drink apparatus, jewellery, chemical industry, field of Environment Protection.
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