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WO2011160533A1 - Alliage de magnésium utilisé pour un matériau d'implant dégradable d'os in vivo et son procédé de fabrication - Google Patents

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

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Publication number
WO2011160533A1
WO2011160533A1 PCT/CN2011/074839 CN2011074839W WO2011160533A1 WO 2011160533 A1 WO2011160533 A1 WO 2011160533A1 CN 2011074839 W CN2011074839 W CN 2011074839W WO 2011160533 A1 WO2011160533 A1 WO 2011160533A1
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Prior art keywords
bone
magnesium alloy
magnesium
alloy
preparation
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Ceased
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PCT/CN2011/074839
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English (en)
Chinese (zh)
Inventor
袁广银
丁文江
李治国
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SHANXI PROVINCE GUJIAO CITY GALAXY MAGNESIUM INDUSTRY Co Ltd
Shanghai Jiao Tong University
Original Assignee
SHANXI PROVINCE GUJIAO CITY GALAXY MAGNESIUM INDUSTRY Co Ltd
Shanghai Jiao Tong University
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Publication of WO2011160533A1 publication Critical patent/WO2011160533A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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 for intra-plant plants and a preparation method thereof.
  • stainless steel and titanium alloy have become widely used materials with good biocompatibility, corrosion resistance and mechanical properties.
  • a common problem in metal implant materials such as stainless steel and titanium alloys is poor mechanical compatibility with biological bone.
  • the tensile strength of stainless steel, titanium alloy, etc. is more than 5 times higher than that of natural bone, and the elastic modulus is more than 10 times higher.
  • the stress stimulation of the matrix bone decreases, the bone remodeling presents a negative balance, resulting in increased bone resorption, reduced bone formation, and induced occlusion bone loss.
  • magnesium alloy as an internal implant material can avoid the pain of removing the patient from the second operation. And the economic burden.
  • magnesium is currently the metal material with the closest biomechanical properties to human bone.
  • the elasticity of magnesium alloy is about 45 GPa is closer to the elastic modulus of human bone than the currently widely used biomaterial titanium alloy (100 GPa) (7 ⁇ 30) GPa) can effectively reduce the "stress shielding effect" and promote bone healing.
  • the magnesium alloy has a high yield strength and can withstand a large load, and is applied to the bearing portion of the bone tissue to support.
  • Magnesium is one of the important nutrients in the human body. It is the fourth metal element in the human body and the second cation in the cell after K+. It catalyzes or activates 325 enzymes in the body and participates in all energy metabolism in the body. It plays an important role in muscle contraction, 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 an intraosseous implant material has a good medical safety foundation.
  • magnesium alloys have poor corrosion resistance and the corrosion forms typically exhibit severe localized corrosion (pitting) rather than the uniform corrosion degradation that must be exhibited by clinically demanding biodegradable biomaterials.
  • localized corrosion is particularly severe in corrosive environments where chloride ions are present or when the pH of the medium is less than 11.5.
  • magnesium alloys must meet the necessary mechanical and morphological requirements during service, so the rate of corrosion degradation should not be too fast.
  • a uniform corrosion degradation mode must be present, because only the uniform corrosion degradation, the service life of magnesium alloy as an implant material in the body can be predicted.
  • the magnesium alloy of the invention has a thermal conductivity greater than 120 W. (m.K)-1 at 20 ° C, a tensile strength greater than 340 MPa, and a yield strength greater than 310 MPa. It can be used as a heat dissipation system structural material for power supplies and electronic devices in aerospace.
  • the prior art is mainly a heat conductive magnesium alloy material designed for a heat dissipation system structure such as an electronic device, and is not designed for a biological material, and the range of the main element Zn content (2.5 to 11 wt%) in the alloy far exceeds the alloy of the present invention.
  • the invention aims at the problems caused by the current non-degradable in vivo metal implant materials in the body, and provides the shortcomings of the current commercial magnesium alloy as a degradable internal implant material in terms of mechanical properties, corrosion performance and biosafety.
  • An in vivo degradable magnesium alloy for bone plant and a preparation method thereof, the material has excellent mechanical properties, ideal uniform corrosion resistance, good biocompatibility, and is suitable for use as a degradable bone plate, bone nail, Bone tissue engineering stents and other orthopedic implant materials.
  • the invention relates to an in vivo degradable magnesium alloy for bone plant, the composition and the weight percentage thereof being: Nd 1.5 ⁇ 4%, Zn 0.1 ⁇ 2%, Ag 0.01 ⁇ 1%, Zr 0 ⁇ 1.0%, impurity 0 ⁇ 0.2%, and the rest is Mg.
  • the component weight percentage of the magnesium alloy for intra-bone plant is preferably Nd 2.5 to 3.5%, Zn 0.1 to 0.5%, Ag. 0.01 ⁇ 0.4%, Zr 0.3 ⁇ 0.6%, and the rest is Mg.
  • the impurities are Fe, Ni, Cu, Al or Si or a combination thereof.
  • the invention relates to a method for preparing the above-mentioned in vivo degradable magnesium alloy for bone plant, which is obtained by melting a raw material metal under a protective atmosphere and then casting the ingot, and extruding to obtain a magnesium alloy bar.
  • 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 ratio is 5-20 in an environment of 250-400 ° C.
  • the present invention relates to the use of the above-described in vivo degradable magnesium alloy for intra-plant plants for the preparation of intraosseous implants such as bone plates, bone nails and bone tissue engineering scaffolds.
  • the ingots prepared by the conventional casting process can be further refined by different extrusion (or rolling) thermal deformation processes and heat treatment processes, and the subsurfaces are subjected to compressive stress. Further, it is advantageous to further reduce the corrosion rate, and finally a biodegradable high-strength tough magnesium alloy having different performance combinations can be obtained.
  • 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, so that the patient can avoid the pain and trouble brought about by the second operation.
  • the medical magnesium alloy of the present invention does not contain a toxic element in the composition design, and avoids adverse effects such as toxic elements such as neurotoxicity caused by Al element in the Mg-Al alloy, and has good biocompatibility.
  • the magnesium alloy of the invention has good comprehensive mechanical properties, uniform corrosion resistance and biocompatibility, and the comprehensive performance is superior to WE43.
  • the typical as-cast microstructure of the Mg-Nd-Zn-Ag-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 a large number of nano-sized Mg12Nd particles are precipitated in the crystal. The typical extrusion deformation microstructure is shown in Fig. 2. According to the requirements of material properties of different internal plants, different thermal processing and heat treatment processes can be used within a certain composition range to control the mechanical properties of the material.
  • the mechanical properties of the material can be varied within the following ranges: tensile yield strength: 188-373 MPa, tensile elongation 8-24%, see Table 1.
  • tensile yield strength 188-373 MPa
  • tensile elongation 8-24% see Table 1.
  • the corrosion mode of the material of the invention in the simulated body fluid is uniform corrosion (see Fig. 3), which satisfies the requirements of the internal implant material for corrosion degradation performance.
  • the alloy material has no obvious cytotoxicity and good biocompatibility, and can meet the requirements of implant materials in vivo.
  • Figure 1 is a typical as-cast microstructure of Mg-Nd-Zn-Ag-Zr magnesium alloy, in which: (a) and its phase composition X-ray diffraction XRD pattern.
  • Fig. 2 is a typical microstructure of Mg-Nd-Zn-Ag-Zr magnesium alloy after extrusion deformation at an extrusion ratio of 5-20 at 350 ° C, in which: (a) is the microscopic direction of extrusion The structure, (b) is a TEM photograph of Mg12Nd particles precipitated inside the grains after extrusion and diffraction spots (c), (d) thereof.
  • Figure 3 is a SEM image of the corrosion surface morphology of the Mg-Nd-Zn-Ag-Zr magnesium alloy after immersion in Hank's simulated body fluid for 10 days, in which: (a) corrosion surface morphology; (b) Cross-sectional morphology of vertically corroded surfaces
  • Mg-Nd-Zn-Ag magnesium alloy ingot by semi-continuous casting (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 1.5% Nd, 2.0% Zn, 1.0% Ag, and the balance is magnesium.
  • the purity of magnesium in the raw material is 99.99%, and the purity of Zn is 99.999%.
  • the purity of silver is 99.99%.
  • the addition of Nd was added in the form of a Mg-30% Nd master alloy. Intercept a certain length of ingot, after 540 °C, 10 h solution treatment and then extruded into 20
  • the round rod of mm has an extrusion temperature of 400 ° C and an extrusion ratio of 5-20.
  • the mechanical properties obtained under this process are: tensile strength 288 MPa, yield strength 197 MPa, elongation at 14%, hardness Hv 70.
  • the material has a corrosion rate of 0.5 in Hank’s simulated body fluid environment. Mm/year.
  • the biological test results show that the material has no obvious cytotoxicity and good biocompatibility. It can be used to prepare intraosseous plants such as bone tissue engineering scaffolds.
  • Mg-Nd-Zn-Ag-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 2.0% Nd, 0.5% Zn, 0.5% Ag, 0.3% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material is 99.99%, and the purity of Zn is 99.999%.
  • the purity of silver is 99.99%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively.
  • Mg-Nd-Zn-Ag-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 2.5% Nd, 0.2% Zn, 0.3% Ag, 0.5% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material is 99.99%, and the purity of Zn is 99.999%.
  • the purity of silver is 99.99%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively.
  • Mg-Nd-Zn-Ag-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 3.0% Nd, 0.2% Zn, 0.01% Ag, 0.5% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material was 99.99%, the purity of Zn was 99.999%, and the purity of silver was 99.99%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively.
  • Mg-Nd-Zn-Ag-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 3.5% Nd, 0.2% Zn, 0.4% Ag, 0.6% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material was 99.99%, the purity of Zn was 99.999%, and the purity of silver was 99.99%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively.
  • the mechanical properties of the magnesium alloy obtained under this process have a tensile strength of 389 MPa, a yield strength of 373 MPa, an elongation of 9%, and a hardness of Hv. 72.
  • Corrosion rate in Hank’s simulated body fluid environment is 0.40 Mm/year, the corrosion mode is uniform corrosion, biological test results show that the material has no obvious cytotoxicity and good biocompatibility. Can make bone plant material.
  • Mg-Nd-Zn-Ag-Zr magnesium alloy ingot by semi-continuous casting method (phi-105 ⁇ 4500 Mm), wherein the alloying elements are 4% Nd, 0.1% Zn, 0.4% Ag, 1.0% Zr, and the balance is magnesium.
  • the purity of magnesium in the raw material was 99.99%, the purity of Zn was 99.999%, and the purity of silver was 99.99%.
  • the addition of Nd and Zr was added in the form of a Mg-30% Nd and Mg-30% Zr binary intermediate alloy, respectively.
  • Example Composition (wt%) Extrusion temperature ( °C ) Extrusion ratio
  • Hardness 1 Mg-1.5Nd-2Zn-1Ag 400 9 288 197 14 70 2 Mg-2.0Nd-0.5Zn-0.5Ag-0.3Zr 350 9 239 188 twenty four 68 3 Mg-2.5Nd-0.2Zn-0.3Ag-0.5Zr 350 9 292 257 16 69 4 Mg-3.0Nd-0.2Zn-0.01Ag-0.5Zr 300 9 332 326 11 70 5 Mg-3.5Nd-0.2Zn-0.4Ag-0.6Zr 250 9 389 373 9 72 6 Mg-4Nd-0.1Zn-0.4Ag-1.0Zr 300 9 378 356 8 73

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  • Mechanical Engineering (AREA)
  • Metallurgy (AREA)
  • Organic Chemistry (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
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  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
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  • Inorganic Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Crystallography & Structural Chemistry (AREA)
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Abstract

L'invention porte sur un alliage de magnésium utilisé pour un matériau d'implant dégradable d'os in vivo. Les composants et leur rapport en poids dans l'alliage de magnésium sont : Nd 1,5 - 4 %, Zn 0,1 - 2 %, Ag 0,01 - 1 %, Zr 0 - 1,0 %, impuretés 0 - 0,2 %, le complément étant Mg. L'alliage de magnésium a une excellente propriété mécanique, une résistance à la corrosion uniforme désirée et une bonne biocompatibilité. L'alliage de magnésium peut être appliqué pour préparer un matériau d'implant biodégradable d'os, tel qu'une plaque vissée, une cheville à os et un support d'ingénierie tissulaire d'os.
PCT/CN2011/074839 2010-06-22 2011-05-30 Alliage de magnésium utilisé pour un matériau d'implant dégradable d'os in vivo et son procédé de fabrication Ceased WO2011160533A1 (fr)

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CN201010204719.9 2010-06-22
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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Cited By (3)

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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
CN108913923A (zh) * 2018-06-29 2018-11-30 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

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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
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
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
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
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
CN118326216B (zh) * 2024-04-11 2024-09-06 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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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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
CN108913923A (zh) * 2018-06-29 2018-11-30 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

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