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WO2011160534A1 - Alliage de magnésium utilisé pour un matériau d'endoprothèse dégradable in vivo et son procédé de fabrication - Google Patents

Alliage de magnésium utilisé pour un matériau d'endoprothèse dégradable in vivo et son procédé de fabrication Download PDF

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Publication number
WO2011160534A1
WO2011160534A1 PCT/CN2011/074842 CN2011074842W WO2011160534A1 WO 2011160534 A1 WO2011160534 A1 WO 2011160534A1 CN 2011074842 W CN2011074842 W CN 2011074842W WO 2011160534 A1 WO2011160534 A1 WO 2011160534A1
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Prior art keywords
stent
magnesium alloy
magnesium
alloy
weight
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Chinese (zh)
Inventor
袁广银
付彭怀
丁文江
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Shanghai Jiao Tong University
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Shanghai Jiao Tong University
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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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A61L27/047—Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/04—Alloys based on magnesium with zinc or cadmium as the next major constituent
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22C—ALLOYS
    • C22C23/00—Alloys based on magnesium
    • C22C23/06—Alloys based on magnesium with a rare earth metal as the next major constituent
    • C—CHEMISTRY; METALLURGY
    • C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22F—CHANGING THE PHYSICAL STRUCTURE OF NON-FERROUS METALS AND NON-FERROUS ALLOYS
    • C22F1/00—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working
    • C22F1/06—Changing the physical structure of non-ferrous metals or alloys by heat treatment or by hot or cold working of magnesium or alloys based thereon
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the invention relates to an alloy and a preparation thereof in the technical field of biomedical materials, in particular to an in vivo degradable magnesium alloy vascular stent material and a manufacturing method thereof.
  • cardiovascular stents In the field of cardiovascular disease treatment, interventional stenting has become the most important means.
  • non-degradable metal materials such as stainless steel, nickel-titanium alloy or cobalt-chromium alloy. Since these stents are permanently implanted in the blood vessels, a series of problems such as acute occlusion of blood vessels, restenosis, permanent mechanical traction and injury, and chronic inflammatory reactions may occur.
  • the biodegradable substance is used as an intravascular stent to support the lumen in a certain period of time, and the blood vessel is kept unobstructed, and then gradually degraded or disappeared, which can effectively prevent acute occlusion and restenosis after vasodilation.
  • biodegradable stents There are three main types of biodegradable stents currently being studied: biodegradable polymer scaffolds, biodegradable iron scaffolds, and biodegradable magnesium scaffolds. There are many materials for the preparation of biodegradable polymer scaffolds. Currently, PGLA and PLLA have been approved by the US FDA as bioengineered materials for human body implantation, and have good biocompatibility and biodegradability.
  • the main problems of polymer scaffold materials are as follows: (1) insufficient mechanical support strength and weak deformability; (2) poor hydrophilicity, weak cell adsorption, and poor X-ray traceability; (3) organization Poor compatibility, can cause aseptic inflammation; (4) relatively large molecular weight, relatively long degradation cycle, chronic mechanical traction caused a greater loss of the blood vessel wall, easy to stimulate tissue hyperplasia; (5) in itself When released and degraded, it produces more heat, which will cause damage to the blood vessel wall and cause embolism. Therefore, its application range is limited. Pure iron is a corrosive material, and iron is a micronutrient element of the human body. Hemoglobin and many enzymes contain iron. Therefore, iron-based alloy is a potential biodegradable scaffold material. However, the existing research results show that the iron scaffold degrades slowly in the cardiovascular environment of the animal, and in addition, the iron is magnetic and hinders the MRI.
  • magnesium alloy As an intravascular stent material, magnesium alloy has the following outstanding advantages: 1) Degradability. Magnesium alloys have a low corrosion potential, are prone to corrosion in the body environment containing chloride ions, and completely degrade in the body in a slow corrosion manner, thereby avoiding the adverse reactions caused by the retention of metal permanent stents in the blood vessels. 2) High biosafety. As an essential nutrient element of the human body, Mg ranks fourth in the human body only after Ca, K and Na. The World Health Organization recommends that adults need to take about 400 mg of magnesium a day.
  • Mg The physiological function of Mg is mainly reflected in its catalysis or activation of 325 enzymes in the body, which participates in almost all energy metabolism in the body, and plays an important role in neuromotor function, physiological function and prevention of circulatory diseases and ischemic heart disease.
  • Magnesium excretion mainly passes through the urinary system, and absorption of magnesium in the human body does not cause a significant increase in serum magnesium content. Therefore, the use of magnesium alloy as a medical degradable vascular stent material has a good medical safety foundation.
  • the world's first degradable magnesium alloy stent was processed by Swiss Biotronik using laser engraving technology to process WE43 magnesium alloy tube.
  • the angiographic minimum lumen diameter was higher than that of the stainless steel stent group (C Mario, H Griffiths, O Goktekin, et al. Drug-eluting bioabsorbable magnesium Stent, Journal of Interventional Cardiology, 2004, 17: 391-395.).
  • the mechanical properties of WE43 magnesium alloy vascular stents need to be further improved.
  • the corrosion performance of the WE43 magnesium alloy stent needs to be further improved to provide a longer service life.
  • the corrosion mode of the WE43 magnesium alloy is similar to that of other commercial magnesium alloys, showing localized corrosion (pitting) rather than the uniform corrosion required clinically. Because only uniform corrosion degradation, the service life of magnesium alloys as implant materials in vivo is predictable. Otherwise, if the magnesium alloy exhibits localized corrosion (pitting), it is prone to local collapse for the vascular stent, and its corroded debris may block the blood vessel, causing serious consequences.
  • magnesium alloy As an intravascular implant material, magnesium alloy must meet the necessary mechanical and morphological requirements during service. On the one hand, the corrosion degradation rate should not be too fast, ensuring the necessary vascular support time, and the degradation mode must be characterized by uniform corrosion degradation. Therefore, the development of magnesium alloys for endovascular scaffolds with in vivo degradation, high toughness, excellent resistance to uniform corrosion degradation, and good biocompatibility has become the focus of research on degradable vascular stent materials.
  • One end of the workpiece is cut into a tubular shape, and the other end is processed into a rod shape.
  • the end of the workpiece is heated, and the pipe ends are drawn. After multiple passes, the diameter can be 2 ⁇ 10 mm.
  • the technology contains toxic elements such as aluminum Al and strontium Sb, which are recognized as neurotoxic elements, and aluminum-containing magnesium alloys cannot be implanted into the human body. Ingestion of the body can destroy the heart and liver function, and inhalation of high levels of sputum can cause sputum poisoning.
  • the World Health Organization stipulates that the content of strontium and daily intake in water should be less than 0.86 ⁇ g/kg per day.
  • the EU stipulates that the content of strontium in food should be less than 20 ppb, while the Sb content in existing patents is as high as 0.1 to 1%.
  • Exceeding the internationally allowed upper limit of entry into the human body It can be seen that this material of the prior art is in fact not allowed to be implanted as a biological material in the human body.
  • the invention aims at the above-mentioned deficiencies of the prior art, and provides an in vivo degradable magnesium alloy vascular stent material and a manufacturing method thereof, which have better mechanical properties and plastic deformation ability than WE43, ideal uniform corrosion resistance and good performance. Biocompatibility, suitable for use in intravascular and bile duct, pancreatic duct and other internal lumens requiring short-term temporary interventional treatment.
  • the invention relates to a magnesium alloy for in vivo degradable endovascular stent, the composition and the weight percentage thereof being: Nd 1 ⁇ 2.49%, Zn 0.1 ⁇ 2%, Zr 0 ⁇ 0.6%, impurity 0 ⁇ 0.2%, the rest is Mg.
  • the component weight percentage of the magnesium alloy for the intravascular stent is preferably Nd 2 to 2.49%, Zn 0.1 to 0.3%, and Zr. 0.4 ⁇ 0.6%, the rest is Mg.
  • the impurities are Fe, Ni, Cu, Al or Si or a combination thereof.
  • the present invention relates to a method for preparing a magnesium alloy for in vivo endogenous degradable stents, which is obtained by smelting a raw material metal under a protective atmosphere and then casting the ingot, and extruding to obtain a magnesium alloy rod.
  • the protective atmosphere refers to a protective atmosphere composed of a mixed gas of CO2 and SF6.
  • the raw material metal is composed of a magnesium block having a purity of 99.99% by weight, a zinc block having a purity of 99.999% by weight, a silver block having a purity of 99.99% by weight, a magnesium-30% cerium alloy, and a magnesium-30% zirconium alloy.
  • the smelting refers to melting at 700-760 ° C in an electric resistance furnace.
  • the extrusion means that the extrusion is performed at an extrusion ratio of 5 to 25 in an environment of 250 to 530 °C.
  • the invention relates to the application of the above-mentioned in vivo degradable medical magnesium alloy, and is used for preparing an endovascular stent and a stent for short-term temporary intervention, such as a cardiovascular stent, a peripheral vascular stent, a bile duct stent, and a bile duct, a pancreatic duct, and the like.
  • a cardiovascular stent such as a cardiovascular stent, a peripheral vascular stent, a bile duct stent, and a bile duct, a pancreatic duct, and the like.
  • Pancreatic duct stent and esophageal stent such as a cardiovascular stent, a peripheral vascular stent, a bile duct stent, and a bile duct, a pancreatic duct, and the like.
  • the magnesium alloy of the present invention can be naturally degraded in the body, and will disappear from the body within a certain period of time after reaching the medical effect, thereby avoiding various adverse reactions caused by the long-term retention of the stent.
  • the corrosion degradation mode of the magnesium alloy of the present invention is uniform corrosion degradation, which ensures that the service life of the implant material prepared in the alloy is predictable.
  • the magnesium alloy of the present invention does not contain a poisonous alloying element and has good biocompatibility.
  • the magnesium alloy of the present invention has excellent mechanical properties, excellent deformability, uniform corrosion resistance and good biocompatibility.
  • the tensile yield strength of the magnesium alloy material prepared by the invention can reach 187 ⁇ 260 MPa, elongation can reach 18 ⁇ 30%, meeting the mechanical properties of the stent material; its corrosion rate in artificial plasma is 0.20 ⁇ 0.40 Mm / year, to meet the corrosion performance requirements of intravascular stent materials; and the material has no obvious cytotoxicity, good blood compatibility, can meet the biocompatibility requirements of intravascular stent materials.
  • the typical as-cast microstructure of the Mg-Nd-Zn-Zr alloy is composed of an alpha-Mg matrix and a skeletal Mg12Nd second phase distributed along the grain boundary. See Figure 1. After hot extrusion deformation, the alloy structure is remarkably refined, and the typical extrusion deformation microstructure is shown in Fig. 2.
  • Figure 1 shows a typical as-cast microstructure of a Mg-Nd-Zn-Zr magnesium alloy.
  • Figure 2 shows a typical extruded microstructure of Mg-Nd-Zn-Zr magnesium alloy.
  • Figure 3 is an SEM image of a cardiovascular stent prepared using a high strength tough Mg-Nd-Zn-Zr magnesium alloy.
  • Mg-Nd-Zn magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 1.0% Nd, 2.0% Zn, and the balance is magnesium.
  • the purity of magnesium in the raw material was 99.99%, and the purity of Zn was 99.999%.
  • the addition of Nd was added in the form of a Mg-30% Nd binary intermediate alloy. Intercept a certain length of ingot, through 540 °C, 10 h solution treatment, extruded into a phi-20 mm round bar, the extrusion temperature is 400 °C, the extrusion ratio is 5-25.
  • the mechanical properties obtained under this process are: tensile strength 258 MPa, yield strength is 187 MPa, elongation is 18%, and hardness is Hv 68.
  • the material has a corrosion rate of 0.40 in artificial plasma. Mm/year. The biological test results show that the material has no obvious cytotoxicity and good biocompatibility.
  • Mg-Nd-Zn-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 2.0% Nd, 0.3% Zn, 0.4% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material was 99.99%, and the purity of Zn was 99.999%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively. Intercept a certain length of ingot, through 540 °C, 10 h solution treatment and extrusion into a phi-20 mm round bar, the extrusion temperature is 450 °C, the extrusion ratio is 5-25.
  • the mechanical properties obtained under this process are: tensile strength 238 MPa, yield strength is 188 MPa, elongation is 30%, and hardness is Hv 67.
  • the material has a corrosion rate of 0.30 in artificial plasma. Mm/year, the corrosion mode is uniform corrosion. The biological test results show that the material has no obvious cytotoxicity and good biocompatibility. Can be used as a vascular stent material.
  • Mg-Nd-Zn-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 2.49% Nd, 0.2% Zn, 0.6% Zr, The rest is magnesium.
  • the purity of magnesium in the raw material was 99.99%, and the purity of Zn was 99.999%.
  • the addition of Nd and Zr was added in the form of Mg-30% Nd and Mg-30Zr% binary intermediate alloy. Intercept a certain length of ingot, through 540 °C, 10 h solution treatment, extruded into a phi-20 mm round bar, extrusion temperature of 350 ° C, extrusion ratio of 5-25.
  • the mechanical properties measured by the magnesium alloy prepared under the process are: tensile strength 252 MPa, yield strength is 227 MPa, elongation is 28%, and hardness is Hv 68.
  • the corrosion rate of this material in artificial plasma is 0.20 Mm/year, the corrosion mode is uniform corrosion.
  • the biological test results show that the material has no obvious cytotoxicity and good biocompatibility, and can be used as an intravascular stent material. It can meet the performance requirements of the intravascular stent material.
  • the prototype of the cardiovascular stent prepared from this material is shown in Fig. 3.
  • Example Composition (wt%) Extrusion temperature ( °C ) Extrusion ratio
  • Hardness ( Hv ) 1 Mg-1Nd-2Zn 400 9 258 187 18 68 2 Mg-2Nd-0.3Zn-0.4Zr 450 9 238 188 30 67 3 Mg-2.49Nd-0.2Zn-0.6Zr 350 9 252 227 28 68

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Abstract

L'invention porte sur un alliage de magnésium utilisé pour un matériau d'endoprothèse dégradable in vivo et sur son procédé de fabrication. Les composants et leur rapport en poids dans l'alliage de magnésium sont : Nd 1 - 2,49 %, Zn 0,1 - 2 %, Zr 0 - 0,6 %, impuretés 0 - 0,2 %, le complément étant Mg. L'alliage de magnésium a une meilleure propriété mécanique et une meilleure propriété de déformation plastique que WE43, une résistance à la corrosion uniforme désirée et une bonne biocompatibilité. L'alliage de magnésium peut être appliqué pour préparer un support de lumière qui est utilisé pour une intervention thérapeutique à court terme sur un vaisseau, le conduit biliaire, le conduit pancréatique, l'œsophage, etc…
PCT/CN2011/074842 2010-06-22 2011-05-30 Alliage de magnésium utilisé pour un matériau d'endoprothèse dégradable in vivo et son procédé de fabrication Ceased WO2011160534A1 (fr)

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CN 201010204719 CN101837145B (zh) 2010-06-22 2010-06-22 生物体内可降解高强韧耐蚀镁合金内植入材料

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PCT/CN2011/074842 Ceased WO2011160534A1 (fr) 2010-06-22 2011-05-30 Alliage de magnésium utilisé pour un matériau d'endoprothèse dégradable in vivo et son procédé de fabrication

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EP3403676A4 (fr) * 2016-06-29 2019-02-20 Amsinomed Medical Co., Ltd Alliage de magnésium dégradable, résistant à la corrosion, de résistance et de ductilité élevées à usage biomédical et procédé pour sa préparation
CN114807839A (zh) * 2022-04-25 2022-07-29 南昌大学 一种牙科用阶梯降解镁合金屏障膜及其制备方法
CN118326216A (zh) * 2024-04-11 2024-07-12 江苏海洋大学 一种高耐腐蚀稀土镁合金的制备方法

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CN101837145B (zh) * 2010-06-22 2013-01-09 上海交通大学 生物体内可降解高强韧耐蚀镁合金内植入材料
CN102100579B (zh) * 2011-04-01 2012-06-27 苏州奥芮济医疗科技有限公司 体内可降解吸收的骨折内固定用金属环抱器
CN102296220B (zh) * 2011-09-15 2013-04-10 重庆大学 一种生物医用耐蚀镁合金及其制备方法
CN102727948A (zh) * 2011-11-14 2012-10-17 上海市第一人民医院 生物可降解镁合金胆管溶石镂刻支架及制备方法
CN104069542B (zh) * 2013-03-26 2017-12-29 深圳先进技术研究院 髌骨组织工程支架及其制造材料和制备方法
CN103614601B (zh) * 2013-12-16 2016-04-06 苏州奥芮济医疗科技有限公司 生物体内可控降解Mg-Ag-Zn-Mn抑菌镁合金植入材料及其制备
CN105126240A (zh) * 2014-06-03 2015-12-09 陈彦彪 一种可降解超微针片
CN104623739B (zh) * 2015-02-28 2017-08-08 天津理工大学 一种涂层镁合金骨钉、骨板和松质骨螺钉及其制备方法
CN104630587A (zh) * 2015-02-28 2015-05-20 天津理工大学 一种骨折内固定用可降解镁合金板、棒材及其制备方法
CN105568103A (zh) * 2016-01-04 2016-05-11 青岛工学院 一种可降解生物医用镁合金
CN107557632B (zh) * 2017-08-16 2020-06-26 北京科技大学 一种可降解生物医用Mg-Zn-Zr-Nd合金材料及其制备方法
CN108014369A (zh) * 2018-01-24 2018-05-11 山东建筑大学 一种可再生钛基复合骨骼材料的制备方法
CN108913923B (zh) * 2018-06-29 2020-03-20 东北大学 一种医用可降解Mg-Nd-Ag三元合金材料及其制备方法
WO2020171794A1 (fr) * 2019-02-20 2020-08-27 Публичное акционерное общество "МОТОР СИЧ" (АО "МОТОР СИЧ") Élément de fixation pour l'ostéosynthèse
CN111020248B (zh) * 2019-12-02 2020-12-18 上海航天精密机械研究所 一种Ag-Zr-Zn中间合金及其制备方法和应用

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Publication number Priority date Publication date Assignee Title
EP3403676A4 (fr) * 2016-06-29 2019-02-20 Amsinomed Medical Co., Ltd Alliage de magnésium dégradable, résistant à la corrosion, de résistance et de ductilité élevées à usage biomédical et procédé pour sa préparation
US11040126B2 (en) 2016-06-29 2021-06-22 Amsinomed Medical Co., Ltd Degradable corrosion-resistant high strength and ductility magnesium alloy for biomedical use and preparation method therefor
CN114807839A (zh) * 2022-04-25 2022-07-29 南昌大学 一种牙科用阶梯降解镁合金屏障膜及其制备方法
CN114807839B (zh) * 2022-04-25 2023-03-14 南昌大学 一种牙科用阶梯降解镁合金屏障膜及其制备方法
CN118326216A (zh) * 2024-04-11 2024-07-12 江苏海洋大学 一种高耐腐蚀稀土镁合金的制备方法

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