CN106381431B - A kind of WE43 magnesium alloy medical bones plate containing Sr and Zn and preparation method thereof - Google Patents
A kind of WE43 magnesium alloy medical bones plate containing Sr and Zn and preparation method thereof Download PDFInfo
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- CN106381431B CN106381431B CN201610789412.7A CN201610789412A CN106381431B CN 106381431 B CN106381431 B CN 106381431B CN 201610789412 A CN201610789412 A CN 201610789412A CN 106381431 B CN106381431 B CN 106381431B
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- 210000000988 bone and bone Anatomy 0.000 title claims abstract description 178
- 229910052725 zinc Inorganic materials 0.000 title claims abstract description 75
- 229910052712 strontium Inorganic materials 0.000 title claims abstract description 73
- 229910000861 Mg alloy Inorganic materials 0.000 title claims abstract description 72
- 238000002360 preparation method Methods 0.000 title claims abstract description 16
- 238000005245 sintering Methods 0.000 claims abstract description 36
- 239000011777 magnesium Substances 0.000 claims abstract description 28
- 239000002994 raw material Substances 0.000 claims abstract description 22
- 229910052726 zirconium Inorganic materials 0.000 claims abstract description 20
- 229910052749 magnesium Inorganic materials 0.000 claims abstract description 14
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims abstract description 13
- 238000000034 method Methods 0.000 claims abstract description 11
- 229910052727 yttrium Inorganic materials 0.000 claims abstract description 10
- 238000007731 hot pressing Methods 0.000 claims abstract description 9
- 238000010438 heat treatment Methods 0.000 claims abstract description 8
- 239000011159 matrix material Substances 0.000 claims abstract description 7
- 239000000843 powder Substances 0.000 claims description 44
- 239000002245 particle Substances 0.000 claims description 24
- 239000000203 mixture Substances 0.000 claims description 19
- 238000000498 ball milling Methods 0.000 claims description 13
- 238000001816 cooling Methods 0.000 claims description 12
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 10
- 238000005303 weighing Methods 0.000 claims description 10
- 239000007789 gas Substances 0.000 claims description 9
- 230000001681 protective effect Effects 0.000 claims description 9
- 238000000748 compression moulding Methods 0.000 claims description 8
- 238000001035 drying Methods 0.000 claims description 5
- 238000002156 mixing Methods 0.000 claims description 5
- 229910052757 nitrogen Inorganic materials 0.000 claims description 5
- 238000003825 pressing Methods 0.000 claims description 4
- 239000011701 zinc Substances 0.000 abstract description 52
- 229910052761 rare earth metal Inorganic materials 0.000 abstract description 29
- 150000002910 rare earth metals Chemical class 0.000 abstract description 28
- 238000005260 corrosion Methods 0.000 abstract description 15
- 230000007797 corrosion Effects 0.000 abstract description 15
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 abstract description 5
- QCWXUUIWCKQGHC-UHFFFAOYSA-N Zirconium Chemical compound [Zr] QCWXUUIWCKQGHC-UHFFFAOYSA-N 0.000 abstract description 5
- CIOAGBVUUVVLOB-UHFFFAOYSA-N strontium atom Chemical compound [Sr] CIOAGBVUUVVLOB-UHFFFAOYSA-N 0.000 abstract description 5
- VWQVUPCCIRVNHF-UHFFFAOYSA-N yttrium atom Chemical compound [Y] VWQVUPCCIRVNHF-UHFFFAOYSA-N 0.000 abstract description 5
- 238000005516 engineering process Methods 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 229910045601 alloy Inorganic materials 0.000 description 5
- 239000000956 alloy Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 239000007943 implant Substances 0.000 description 4
- 238000002513 implantation Methods 0.000 description 3
- 208000010392 Bone Fractures Diseases 0.000 description 2
- 210000003484 anatomy Anatomy 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 238000006731 degradation reaction Methods 0.000 description 2
- 239000007769 metal material Substances 0.000 description 2
- 150000003839 salts Chemical class 0.000 description 2
- 239000007921 spray Substances 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 229910052688 Gadolinium Inorganic materials 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- 229910052779 Neodymium Inorganic materials 0.000 description 1
- OAICVXFJPJFONN-UHFFFAOYSA-N Phosphorus Chemical compound [P] OAICVXFJPJFONN-UHFFFAOYSA-N 0.000 description 1
- 206010066902 Surgical failure Diseases 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 238000009825 accumulation Methods 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 239000003519 biomedical and dental material Substances 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000037182 bone density Effects 0.000 description 1
- 230000008468 bone growth Effects 0.000 description 1
- 150000001720 carbohydrates Chemical class 0.000 description 1
- 235000014633 carbohydrates Nutrition 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
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- 238000004090 dissolution Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 230000012010 growth Effects 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 229940080286 lowsium Drugs 0.000 description 1
- 239000012567 medical material Substances 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000007935 neutral effect Effects 0.000 description 1
- 229910052698 phosphorus Inorganic materials 0.000 description 1
- 239000011574 phosphorus Substances 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229910001427 strontium ion Inorganic materials 0.000 description 1
- 159000000008 strontium salts Chemical class 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 230000008467 tissue growth Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
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- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
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- 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
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/12—Both compacting and sintering
- B22F3/14—Both compacting and sintering simultaneously
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B22—CASTING; POWDER METALLURGY
- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/24—After-treatment of workpieces or articles
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- C—CHEMISTRY; METALLURGY
- C22—METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
- C22C—ALLOYS
- C22C1/00—Making non-ferrous alloys
- C22C1/04—Making non-ferrous alloys by powder metallurgy
- C22C1/0408—Light metal alloys
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- 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
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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
- A61L2430/00—Materials or treatment for tissue regeneration
- A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants
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- B22—CASTING; POWDER METALLURGY
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- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
- B22F3/12—Both compacting and sintering
- B22F3/14—Both compacting and sintering simultaneously
- B22F2003/145—Both compacting and sintering simultaneously by warm compacting, below debindering temperature
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- B22F—WORKING METALLIC POWDER; MANUFACTURE OF ARTICLES FROM METALLIC POWDER; MAKING METALLIC POWDER; APPARATUS OR DEVICES SPECIALLY ADAPTED FOR METALLIC POWDER
- B22F3/00—Manufacture of workpieces or articles from metallic powder characterised by the manner of compacting or sintering; Apparatus specially adapted therefor ; Presses and furnaces
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Abstract
本发明涉及一种含有Sr和Zn的WE43镁合金医用接骨板及其制备方法。其特征是，由以下质量百分比的原料采用热压烧结工艺成型，Y(钇)：4％，RE(稀土)：3％，Sr(锶)：0.5％～2％，Zn(锌)：0.5％～2％，Zr(锆)：0.5％，余量为Mg(镁)。其制造工艺特征在于采用热压烧结工艺成型，此医用齿型接骨板为圆弧状，包括接骨板基体，设置于骨板基体两侧的骨板翼，设置于骨板翼上的B类螺钉孔，和设置于骨板基体两端的A类螺钉孔；所述B类螺钉孔和A类螺钉孔内均设有螺纹，用于与相应的固定螺钉配合，本发明结构简单，避免了较复杂的热处理工艺，且合理的组分添加具有更加良好的机械性能和耐腐蚀性能。
The invention relates to a WE43 magnesium alloy medical bone plate containing Sr and Zn and a preparation method thereof. It is characterized in that it is formed by hot pressing and sintering process from the following raw materials in mass percentage, Y (yttrium): 4%, RE (rare earth): 3%, Sr (strontium): 0.5% to 2%, Zn (zinc): 0.5% %～2%, Zr (zirconium): 0.5%, and the balance is Mg (magnesium). Its manufacturing process is characterized by the use of hot pressing and sintering technology. The medical tooth-shaped bone plate is arc-shaped, including the bone plate base, the bone plate wings set on both sides of the bone plate base, and the B-type screws set on the bone plate wings. holes, and the A-type screw holes arranged at both ends of the bone plate matrix; the B-type screw holes and the A-type screw holes are provided with threads for matching with corresponding fixing screws. The structure of the present invention is simple and avoids more complicated Advanced heat treatment process, and reasonable component addition has better mechanical properties and corrosion resistance.
Description
技术领域technical field
本发明涉及医用生物植入材料领域，具体涉及一种含有Sr和Zn的WE43镁合金医用接骨板及其制备方法。The invention relates to the field of medical biological implant materials, in particular to a WE43 magnesium alloy medical bone plate containing Sr and Zn and a preparation method thereof.
背景技术Background technique
近年来，生物医学材料的应用已经引起了材料学家，医学家以及工业应用的广泛关注。很多医用材料，例如高分子聚合物，陶瓷以及金属材料已经被应用到生物医学当中。金属材料作为一种生物医学材料在硬组织替换和植入领域中起到非常重要的作用。其中，镁及镁合金以其高的比强度、比刚度，良好的生物相容性以及接近自然骨的弹性模量和密度在可降解骨、支架和组织的植入中具有很大的应用潜力。但是，镁及镁合金作为医用植入材料的致命缺点是纯镁的强度太低，并且镁合金在人体环境内腐蚀太快从而导致大量氢气积累产生皮下气泡。大量研究表明，镁及镁合金在植入生物体后，由于其生物讲解速度与组织生长速度不匹配，最终导致手术失败。In recent years, the application of biomedical materials has attracted extensive attention from materials scientists, medical scientists, as well as industrial applications. Many medical materials, such as high molecular polymers, ceramics and metal materials have been applied in biomedicine. As a biomedical material, metal materials play a very important role in the field of hard tissue replacement and implantation. Among them, magnesium and magnesium alloys have great application potential in the implantation of degradable bones, scaffolds and tissues due to their high specific strength, specific stiffness, good biocompatibility, and elastic modulus and density close to natural bone. . However, the fatal disadvantage of magnesium and magnesium alloys as medical implant materials is that the strength of pure magnesium is too low, and magnesium alloys corrode too quickly in the human body environment, resulting in the accumulation of a large amount of hydrogen and subcutaneous bubbles. A large number of studies have shown that after implantation of magnesium and magnesium alloys into organisms, the speed of biological decomposition does not match the speed of tissue growth, which eventually leads to surgical failure.
含铝系镁合金具有较高的机械性能和抗腐蚀性能，但是从健康角度考虑该类合金不具备长期应用于人体的优势。目前，比较受欢迎的商用镁合金是无铝系稀土镁合金，WE43为其中代表，它的组分设计是Mg-4％Y-3％RE(Nd，Gd)-0.5％Zr。Biotronik公司已经制作了临床的可降解血管支架，在动物实验中取得了良好的效果，但是WE43作为固定骨板的在人体体内和体外降解速率并不理想。因此，寻求一种综合机械强度和腐蚀性能比较理想的镁合金医用植入材料至关重要。Aluminum-containing magnesium alloys have high mechanical properties and corrosion resistance, but from the perspective of health, this type of alloy does not have the advantage of long-term application to the human body. At present, the more popular commercial magnesium alloys are aluminum-free rare earth magnesium alloys, WE43 is the representative of them, and its composition design is Mg-4%Y-3%RE(Nd, Gd)-0.5%Zr. Biotronik has produced a clinical degradable vascular stent, which has achieved good results in animal experiments, but the degradation rate of WE43 as a fixed bone plate in the human body and in vitro is not ideal. Therefore, it is very important to seek a magnesium alloy medical implant material with ideal comprehensive mechanical strength and corrosion performance.
发明内容Contents of the invention
本发明针对上述技术的不足，提出一种具有优异的机械性能和耐腐蚀性能的镁合金医用接骨板。Aiming at the deficiencies of the above technologies, the present invention proposes a magnesium alloy medical bone plate with excellent mechanical properties and corrosion resistance.
本发明的技术方案是：Technical scheme of the present invention is:
一种含有Sr和Zn的WE43镁合金医用接骨板，其特征是，由以下质量百分比的原料采用热压烧结工艺成型，A WE43 magnesium alloy medical bone plate containing Sr and Zn is characterized in that it is formed by a hot pressing sintering process from the following mass percentage raw materials,
Y(钇)：4％，RE(稀土)：3％，Sr(锶)：0.5％～2％，Zn(锌)：0.5％～2％，Zr(锆)：0.5％，余量为Mg(镁)。Y (yttrium): 4%, RE (rare earth): 3%, Sr (strontium): 0.5% to 2%, Zn (zinc): 0.5% to 2%, Zr (zirconium): 0.5%, and the balance is Mg (magnesium).
优选地，所述RE包括Nd元素和/或Gd元素；Preferably, the RE includes Nd element and/or Gd element;
优选地，所述RE包括Nd元素和Gd元素；Preferably, the RE includes Nd element and Gd element;
优选地，Nd元素和Gd元素的质量比为1：1。Preferably, the mass ratio of Nd element to Gd element is 1:1.
优选地，Preferably,
所述Y为Y粉，Y粉粒度为75μm，纯度在99.5％以上；The Y is Y powder, the particle size of Y powder is 75 μm, and the purity is above 99.5%;
所述RE为RE粉，所述RE粉的粒度为75μm，纯度在99.5％以上；The RE is RE powder, the particle size of the RE powder is 75 μm, and the purity is above 99.5%;
所述Sr为Sr粉，所述Sr粉的粒度为100μm，纯度在99.5％以上；The Sr is Sr powder, the particle size of the Sr powder is 100 μm, and the purity is above 99.5%;
所述Zn为Zn粉，所述Zn粉的粒度为75μm，纯度在99.5％以上；The Zn is Zn powder, the particle size of the Zn powder is 75 μm, and the purity is above 99.5%;
所述Zr为Zr粉，所述Zr粉的粒度为100μm，纯度在99.5％以上；The Zr is Zr powder, the particle size of the Zr powder is 100 μm, and the purity is above 99.5%;
所述Mg为镁粉，Mg粉的粒度为150μm，纯度在99.5％以上。The Mg is magnesium powder, the particle size of the Mg powder is 150 μm, and the purity is above 99.5%.
本发明还提供一种含有Sr和Zn的WE43镁合金医用接骨板，其特征是，包括接骨板基体，设置于骨板基体两侧的骨板翼，设置于骨板翼上的B类螺钉孔，和设置于骨板基体两端的A类螺钉孔；The present invention also provides a WE43 magnesium alloy medical bone plate containing Sr and Zn, which is characterized in that it includes a bone plate base, bone plate wings arranged on both sides of the bone plate base, and B-type screw holes arranged on the bone plate wings , and A-type screw holes arranged at both ends of the bone plate matrix;
所述B类螺钉孔和A类螺钉孔内均设有螺纹，用于与相应的固定螺钉配合；Both the B-type screw holes and the A-type screw holes are provided with threads for matching with corresponding fixing screws;
优选地，所述骨板翼的横截面为圆弧状；也就是说，骨板翼为横截面为圆弧状的槽型，或者其他符合人骨骼结构的形状，以起到更好的骨钉效果。Preferably, the cross section of the bone plate wing is arc-shaped; that is to say, the bone plate wing is a groove shape with a circular arc cross section, or other shapes that conform to the human bone structure, so as to better bone nail effect.
优选地，所述骨板翼至少为2个；例如2个，3个，4个，5个，6个，7个，8个等，优选为2个，4个，6个，8个等偶数个。Preferably, there are at least two bone plate wings; for example, 2, 3, 4, 5, 6, 7, 8, etc., preferably 2, 4, 6, 8, etc. an even number.
优选地，所述骨板翼均匀分布于骨板基体侧边；Preferably, the bone plate wings are evenly distributed on the side of the bone plate base;
优选地，所述骨板基体上还设置有至少1个B类螺钉孔；用于用固定螺钉将接骨板固定于人体骨骼上。Preferably, at least one type B screw hole is provided on the base of the bone plate; it is used for fixing the bone plate to the human skeleton with fixing screws.
优选地，所述骨板基体上的B类螺钉孔均匀分布，可使固定时受力更均匀，从而达到更好的骨钉效果。Preferably, the B-type screw holes on the base of the bone plate are evenly distributed, which can make the force applied more uniformly during fixation, thereby achieving a better bone nail effect.
优选地，A类螺钉孔的孔径大于B类螺钉孔的孔径；Preferably, the aperture of the type A screw hole is larger than the aperture of the type B screw hole;
优选地，所述骨板翼为齿型、半圆型、半椭圆型中的一种或几种。Preferably, the bone plate wing is one or more of a tooth shape, a semicircle shape, and a half ellipse shape.
优选地，所述骨板翼与接骨板基体形成的夹角为90°～180°，例如90°，100°，110°，120°，150°，160°等。Preferably, the angle formed between the bone plate wing and the bone plate base is 90°-180°, such as 90°, 100°, 110°, 120°, 150°, 160° and so on.
优选地，所述骨板翼与接骨板基体形成的夹角为100°～150°，例如90°，100°，110°，120°，150°等。Preferably, the included angle formed by the bone plate wings and the bone plate base is 100°-150°, such as 90°, 100°, 110°, 120°, 150° and so on.
优选地，所述骨板翼与接骨板基体形成的夹角与人骨结构走向一致(骨板翼与接骨板按照人骨解剖设计，为圆弧状)；使其与人骨贴合，使固定更加稳定，更有利于骨骼的恢复。Preferably, the angle formed between the bone plate wing and the bone plate base is consistent with the direction of the human bone structure (the bone plate wing and the bone plate are designed according to the anatomy of the human bone, and are arc-shaped); make it fit the human bone to make the fixation more stable , more conducive to bone recovery.
优选地，所述接骨板为一体成型制得。Preferably, the bone plate is integrally formed.
本发明还提供了一种含有Sr和Zn的WE43镁合金医用接骨板的制备方法，其特征是，包括以下步骤：The present invention also provides a preparation method of a WE43 magnesium alloy medical bone plate containing Sr and Zn, which is characterized in that it comprises the following steps:
①称取原料：根据上述的质量百分比称取原料；① Weighing raw materials: Weighing raw materials according to the above mass percentage;
②混料球磨：取步骤①称取的Mg、Y、RE、Sr、Zn和Zr原料，干燥后放入球磨罐中进行球磨混合成混合料；② Mixing ball milling: take the Mg, Y, RE, Sr, Zn and Zr raw materials weighed in step ①, put them into a ball mill tank after drying and mix them into a mixture;
③室温压制成型：将步骤②中所述混合料在室温下放到模具中进行压制成型，得到骨板坯料；③Compressing at room temperature: putting the mixture described in step ② into a mold at room temperature for compression molding to obtain a bone plate blank;
④热压烧结：将步骤③中压制成型的骨板坯料放置于相同尺寸规格的模具中，将模具放置于保护气体保护氛围的热压烧结炉中进行烧结；所述的保护气体为现有技术中热压烧结过程中常用的保护气体，包括但不限于氮气。④Hot-press sintering: place the bone plate blank pressed and formed in step ③ into a mold of the same size and specification, and place the mold in a hot-press sintering furnace with a protective gas atmosphere for sintering; the protective gas mentioned is the prior art The protective gas commonly used in the medium hot pressing sintering process includes but not limited to nitrogen.
⑤热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后再加热，保温，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板。⑤Heat treatment and cooling: take out the medical bone plate sintered in step ④, take it out of the mold, heat it, keep it warm, and cool it to room temperature to get the WE43 magnesium alloy medical tooth bone plate containing Sr and Zn.
优选地，Preferably,
步骤②中，球磨机转速100-200r/min，球磨时间为8-12h；In step ②, the speed of the ball mill is 100-200r/min, and the ball milling time is 8-12h;
优选地，步骤②中，球磨机转速160r/min，球磨时间为10h。Preferably, in step ②, the rotational speed of the ball mill is 160r/min, and the ball milling time is 10h.
优选地，Preferably,
步骤③中，压制成型的压力为30-60MPa；In step ③, the pressure of compression molding is 30-60MPa;
优选地，步骤③中，压制成型的压力为40MPa。Preferably, in step ③, the pressing pressure is 40MPa.
优选地，步骤④中，所述保护气体为氮气。Preferably, in step ④, the protective gas is nitrogen.
优选地，Preferably,
步骤④中，烧结的条件为：先升温至180-220℃，保温0.5h；再升温到550-800℃，保温1-3h，压力始终控制在30-50MPa；In step ④, the sintering conditions are as follows: firstly raise the temperature to 180-220°C, keep it warm for 0.5h; then raise the temperature to 550-800°C, keep it warm for 1-3h, and keep the pressure at 30-50MPa;
步骤④中，烧结的条件为：先升温至200℃，保温0.5h；再升温到650℃，保温1h，压力始终控制在40MPa。In step ④, the sintering conditions are as follows: first raise the temperature to 200°C and keep it for 0.5h; then raise the temperature to 650°C and keep it for 1h; the pressure is always controlled at 40MPa.
优选地，Preferably,
步骤⑤为热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后加热到250-350℃，保温2-8h，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板；Step ⑤ is heat treatment and cooling: take out the medical bone plate sintered in step ④, take it out, heat it to 250-350°C, keep it warm for 2-8 hours, and then cool it to room temperature to get the WE43 magnesium alloy medical tooth shape containing Sr and Zn bone plate;
优选地，Preferably,
步骤⑤为热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后加热到300℃，保温5h，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板。Step ⑤ is heat treatment and cooling: remove the medical bone plate sintered in step ④, take it out, heat it to 300°C, keep it warm for 5 hours, and then cool it to room temperature to obtain a WE43 magnesium alloy medical tooth-shaped bone plate containing Sr and Zn.
Sr元素和Zn元素为人体必需元素，Zn在体内所以细胞中广泛分布，是诸如视力、味觉和嗅觉等身体机能所需元素，参与碳水化合物、蛋白质和磷的代谢，促进正常细胞和细胞膜的功能；人体含有约140mg的Sr且99％位于骨头中，锶盐对骨的形成具有促进作用，有文献指出，Sr含量在0.3％～2.5％的Mg-Sr血管支架在动脉内3周无血栓形成。Zn可以有效改善镁合金的力学性能，并在一定程度上改善镁合金的耐蚀性能，且Zn元素与Zr元素组合，成为强大的晶粒细化剂；Sr对镁合金的晶粒有明显的细化效果，还可以减少合金中缩孔数量并聚集缩孔，提高了接骨板的强度，减缓了腐蚀速率，Sr的加入还使镁合金中产生了新相，这些稳定的新相使合金(镁合金医用接骨板)具有较好的抗蠕变能力。Sr and Zn elements are essential elements for the human body. Zn is widely distributed in all cells in the body. It is an element required for body functions such as vision, taste, and smell. It participates in the metabolism of carbohydrates, proteins, and phosphorus, and promotes the functions of normal cells and cell membranes. The human body contains about 140mg of Sr and 99% of it is located in the bone. Strontium salts can promote the formation of bone. It has been pointed out in the literature that Mg-Sr stents with a Sr content of 0.3% to 2.5% have no thrombosis in the artery for 3 weeks . Zn can effectively improve the mechanical properties of magnesium alloys, and improve the corrosion resistance of magnesium alloys to a certain extent, and the combination of Zn and Zr elements becomes a powerful grain refiner; Sr has a significant effect on the grains of magnesium alloys. The refinement effect can also reduce the number of shrinkage cavities in the alloy and gather shrinkage cavities, which improves the strength of the bone plate and slows down the corrosion rate. The addition of Sr also causes new phases to be produced in the magnesium alloy, and these stable new phases make the alloy ( Magnesium alloy medical bone plate) has good creep resistance.
本发明的有益效果在于：The beneficial effects of the present invention are:
(1)本发明的含有Sr和Zn的WE43镁合金医用接骨板添加了人体必需元素Sr元素和Zn元素，同时减少了稀土元素的用量。(1) The WE43 magnesium alloy medical bone plate containing Sr and Zn of the present invention adds Sr element and Zn element, which are essential elements for human body, while reducing the amount of rare earth elements.
(2)本发明的含有Sr和Zn的WE43镁合金医用接骨板，提高了镁合金医用接骨板的力学性能，并改善了其耐蚀性能，并且具有较好的抗蠕变能力。(2) The WE43 magnesium alloy medical bone plate containing Sr and Zn of the present invention improves the mechanical properties of the magnesium alloy medical bone plate, improves its corrosion resistance, and has better creep resistance.
(3)本发明的含有Sr和Zn的WE43镁合金医用接骨板具有具有优异的致密度和良好的机械性能，该WE43镁合金的密度约1.85g/cm3，接近人骨密度(1.75g/cm3)，弹性模量约为45GPa，能够消除植入物与人骨之间的“应力遮挡效应”，且与WE43(抗拉强度约为250MPa，屈服强度约为155MPa)相比，该医用接骨板的抗拉强度可达到268MPa，且屈服强度也提高到170MPa；且该WE43镁合金在腐蚀降解的过程中，具有良好的耐腐蚀性能，骨板的溶解速率和人骨的愈合速率大致匹配，腐蚀过程中释放的Sr离子能够诱导骨生长。(3) The WE43 magnesium alloy medical bone plate containing Sr and Zn of the present invention has excellent density and good mechanical properties, and the density of the WE43 magnesium alloy is about 1.85g/cm 3 , which is close to human bone density (1.75g/cm 3 ), the elastic modulus is about 45GPa, which can eliminate the "stress shielding effect" between the implant and the human bone, and compared with WE43 (the tensile strength is about 250MPa, the yield strength is about 155MPa), the medical bone plate The tensile strength can reach 268MPa, and the yield strength is also increased to 170MPa; and the WE43 magnesium alloy has good corrosion resistance during the corrosion degradation process, and the dissolution rate of the bone plate roughly matches the healing rate of the human bone. The released Sr ions can induce bone growth.
(4)本发明的含有Sr和Zn的WE43镁合金医用接骨板贴合人体骨表形状，螺钉孔分布合理，利于骨组织附着与生长。(4) The WE43 magnesium alloy medical bone plate containing Sr and Zn of the present invention conforms to the shape of human bone surface, and the distribution of screw holes is reasonable, which is beneficial to the attachment and growth of bone tissue.
附图说明Description of drawings
附图1是本发明实施例的立体结构示意图；Accompanying drawing 1 is the three-dimensional structure schematic diagram of the embodiment of the present invention;
附图2是本发明实施例的立体正视图；Accompanying drawing 2 is the three-dimensional front view of the embodiment of the present invention;
附图3是本发明实施例的立体左视图，Accompanying drawing 3 is the perspective left view of the embodiment of the present invention,
其中，1为接骨板基体，2为齿型骨板翼，3为A类螺钉孔，4为B类螺钉孔。Among them, 1 is the base body of the bone plate, 2 is the wing of the toothed bone plate, 3 is the A-type screw hole, and 4 is the B-type screw hole.
具体实施方式Detailed ways
为了更好地理解本发明，下面结合实施例进一步阐明本发明的内容，但本发明的内容不仅仅局限于下面的实施例，实施例不应视作对本发明保护范围的限定。In order to better understand the present invention, the content of the present invention is further illustrated below in conjunction with the examples, but the content of the present invention is not limited to the following examples, and the examples should not be regarded as limiting the protection scope of the present invention.
一种含有Sr和Zn的WE43镁合金医用接骨板，由以下质量百分比的原料采用热压烧结工艺成型，A WE43 magnesium alloy medical bone plate containing Sr and Zn is formed by a hot pressing sintering process from the following mass percentage raw materials,
Y(钇)：4％，RE(稀土)：3％，Sr(锶)：0.5％～2％，Zn(锌)：0.5％～2％，Zr(锆)：0.5％，余量为Mg(镁)。Y (yttrium): 4%, RE (rare earth): 3%, Sr (strontium): 0.5% to 2%, Zn (zinc): 0.5% to 2%, Zr (zirconium): 0.5%, and the balance is Mg (magnesium).
优选地，所述RE包括Nd元素和/或Gd元素；Preferably, the RE includes Nd element and/or Gd element;
优选地，所述RE包括Nd元素和Gd元素；Preferably, the RE includes Nd element and Gd element;
优选地，Nd元素和Gd元素的质量比为1：1。Preferably, the mass ratio of Nd element to Gd element is 1:1.
优选地，Preferably,
所述Y为Y粉，Y粉粒度为75μm，纯度在99.5％以上；The Y is Y powder, the particle size of Y powder is 75 μm, and the purity is above 99.5%;
所述RE为RE粉，所述RE粉的粒度为75μm，纯度在99.5％以上；The RE is RE powder, the particle size of the RE powder is 75 μm, and the purity is above 99.5%;
所述Sr为Sr粉，所述Sr粉的粒度为100μm，纯度在99.5％以上；The Sr is Sr powder, the particle size of the Sr powder is 100 μm, and the purity is above 99.5%;
所述Zn为Zn粉，所述Zn粉的粒度为75μm，纯度在99.5％以上；The Zn is Zn powder, the particle size of the Zn powder is 75 μm, and the purity is above 99.5%;
所述Zr为Zr粉，所述Zr粉的粒度为100μm，纯度在99.5％以上；The Zr is Zr powder, the particle size of the Zr powder is 100 μm, and the purity is above 99.5%;
所述Mg为镁粉，Mg粉的粒度为150μm，纯度在99.5％以上。The Mg is magnesium powder, the particle size of the Mg powder is 150 μm, and the purity is above 99.5%.
本发明还提供一种含有Sr和Zn的WE43镁合金医用接骨板，如图1、2、3所示，包括接骨板基体1，设置于骨板基体两侧的骨板翼2，设置于骨板翼上的B类螺钉孔4，和设置于骨板基体两端的A类螺钉孔3；The present invention also provides a WE43 magnesium alloy medical bone plate containing Sr and Zn, as shown in Fig. Type B screw holes 4 on the plate wings, and Type A screw holes 3 arranged at both ends of the bone plate matrix;
所述B类螺钉孔4和A类螺钉孔3内均设有螺纹，用于与相应的固定螺钉配合；Both the B-type screw holes 4 and the A-type screw holes 3 are provided with threads for matching with corresponding fixing screws;
优选地，所述骨板翼的横截面为圆弧状；Preferably, the cross-section of the bone plate wing is arc-shaped;
优选地，所述骨板翼2至少为2个；Preferably, there are at least two bone plate wings 2;
优选地，所述骨板翼2均匀分布于骨板基体1侧边；Preferably, the bone plate wings 2 are evenly distributed on the side of the bone plate base 1;
优选地，所述骨板基体1上还设置有至少1个B类螺钉孔4；Preferably, at least one B-type screw hole 4 is also provided on the bone plate base 1;
优选地，所述骨板基体上的B类螺钉孔4均匀分布；Preferably, the B-type screw holes 4 on the base of the bone plate are evenly distributed;
优选地，A类螺钉孔3的孔径大于B类螺钉孔4的孔径；Preferably, the diameter of the type A screw hole 3 is greater than the diameter of the type B screw hole 4;
优选地，所述骨板翼2为齿型、半圆型、半椭圆型中的一种或几种。Preferably, the bone plate wing 2 is one or more of a tooth shape, a semicircle shape, and a half ellipse shape.
优选地，所述骨板翼2与接骨板基体1形成的夹角为90°～180°；Preferably, the angle formed between the bone plate wing 2 and the bone plate base 1 is 90°-180°;
优选地，所述骨板翼2与接骨板基体1形成的夹角为100°～150°；Preferably, the angle formed between the bone plate wing 2 and the bone plate base 1 is 100°-150°;
优选地，所述骨板翼2与接骨板基体1形成的夹角与人骨结构走向一致(骨板翼与接骨板按照人骨解剖设计，为圆弧状)；Preferably, the angle formed between the bone plate wing 2 and the bone plate base 1 is consistent with the direction of the human bone structure (the bone plate wing and the bone plate are designed according to the anatomy of the human bone, and are arc-shaped);
优选地，所述接骨板为一体成型制得。Preferably, the bone plate is integrally formed.
本发明在使用时，首先将伤者断骨与接骨板基体1用与A类螺钉孔3相匹配的螺钉固定，然后固定骨板翼2，最后通过与B类螺钉孔4相匹配的螺钉进行最终固定，骨板翼2的存在使较小的接骨板有较大的固定辐射范围，使接骨板基体1与伤者断骨固定更加牢固，减少手术失败的可能性。When the present invention is in use, first fix the broken bone of the injured person with the base body 1 of the bone plate with screws matching the A-type screw holes 3, then fix the bone plate wings 2, and finally fix the bone plate with screws matching the B-type screw holes 4. For final fixation, the presence of the bone plate wings 2 enables the smaller bone plate to have a larger fixed radiation range, which makes the bone plate base 1 and the broken bone of the injured more firmly fixed, reducing the possibility of operation failure.
上述含有Sr和Zn的WE43镁合金医用接骨板的制备方法，包括以下步骤：The preparation method of the above-mentioned WE43 magnesium alloy medical bone plate containing Sr and Zn comprises the following steps:
①称取原料：根据上述的质量百分比称取原料；① Weighing raw materials: Weighing raw materials according to the above mass percentage;
②混料球磨：取步骤①称取的Mg、Y、RE、Sr、Zn和Zr原料，干燥后放入球磨罐中进行球磨混合成混合料；② Mixing ball milling: take the Mg, Y, RE, Sr, Zn and Zr raw materials weighed in step ①, put them into a ball mill tank after drying and mix them into a mixture;
③室温压制成型：将步骤②中所述混合料在室温下放到模具中进行压制成型，得到骨板坯料；③Compressing at room temperature: putting the mixture described in step ② into a mold at room temperature for compression molding to obtain a bone plate blank;
④热压烧结：将步骤③中压制成型的骨板坯料放置于相同尺寸规格的模具中，将模具放置于保护气体保护氛围的热压烧结炉中进行烧结；④Hot-press sintering: Place the bone plate blank pressed and formed in step ③ into a mold of the same size and specification, and place the mold in a hot-press sintering furnace with a protective gas atmosphere for sintering;
⑤热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后再加热，保温，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板。⑤Heat treatment and cooling: take out the medical bone plate sintered in step ④, take it out of the mold, heat it, keep it warm, and cool it to room temperature to get the WE43 magnesium alloy medical tooth bone plate containing Sr and Zn.
优选地，Preferably,
步骤②中，球磨机转速100～200r/min，球磨时间为8-12h；In step ②, the speed of the ball mill is 100-200r/min, and the ball milling time is 8-12h;
优选地，步骤②中，球磨机转速160r/min，球磨时间为10h。Preferably, in step ②, the rotational speed of the ball mill is 160r/min, and the ball milling time is 10h.
优选地，Preferably,
步骤③中，压制成型的压力为30-60MPa；In step ③, the pressure of compression molding is 30-60MPa;
优选地，步骤③中，压制成型的压力为40MPa。Preferably, in step ③, the pressing pressure is 40MPa.
优选地，Preferably,
步骤④中，所述保护气体为氮气。In step ④, the protective gas is nitrogen.
优选地，Preferably,
步骤④中，烧结的条件为：先升温至180-220℃，保温0.5h；再升温到550-800℃，保温1-3h，压力始终控制在30-50MPa；In step ④, the sintering conditions are as follows: firstly raise the temperature to 180-220°C, keep it warm for 0.5h; then raise the temperature to 550-800°C, keep it warm for 1-3h, and keep the pressure at 30-50MPa;
步骤④中，烧结的条件为：先升温至200℃，保温0.5h；再升温到650℃，保温1h，压力始终控制在40MPa。In step ④, the sintering conditions are as follows: first raise the temperature to 200°C and keep it for 0.5h; then raise the temperature to 650°C and keep it for 1h; the pressure is always controlled at 40MPa.
优选地，Preferably,
步骤⑤为热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后加热到250-350℃，保温2-8h，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板；Step ⑤ is heat treatment and cooling: take out the medical bone plate sintered in step ④, take it out, heat it to 250-350°C, keep it warm for 2-8 hours, and then cool it to room temperature to get the WE43 magnesium alloy medical tooth shape containing Sr and Zn bone plate;
优选地，Preferably,
步骤⑤为热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后加热到300℃，保温5h，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板。Step ⑤ is heat treatment and cooling: remove the medical bone plate sintered in step ④, take it out, heat it to 300°C, keep it warm for 5 hours, and then cool it to room temperature to obtain a WE43 magnesium alloy medical tooth-shaped bone plate containing Sr and Zn.
下面结合具体实施例对本发明进行说明，但本发明不仅限于这些例子。实施例1The present invention will be described below in conjunction with specific embodiments, but the present invention is not limited to these examples. Example 1
一种含有Sr和Zn的WE43镁合金医用接骨板，由以下质量百分比的原料采用热压烧结工艺成型，A WE43 magnesium alloy medical bone plate containing Sr and Zn is formed by a hot pressing sintering process from the following mass percentage raw materials,
Y(Y粉，Y粉粒度为75μm，纯度在99.5％以上)：4％，RE(RE粉，RE粉的粒度为75μm，纯度在99.5％以上)：3％，Sr(Sr粉，所述Sr粉的粒度为100μm，纯度在99.5％以上)：0.5％，Zn(Zn粉，所述Zn粉的粒度为75μm，纯度在99.5％以上)：0.5％，Zr(Zr粉，所述Zr粉的粒度为100μm，纯度在99.5％以上)：0.5％，余量为Mg(镁粉，Mg粉的粒度为150μm，纯度在99.5％以上)。Y (Y powder, the particle size of Y powder is 75 μm, and the purity is above 99.5%): 4%, RE (RE powder, the particle size of RE powder is 75 μm, and the purity is above 99.5%): 3%, Sr (Sr powder, the The particle size of Sr powder is 100 μm, and the purity is above 99.5%): 0.5%, Zn (Zn powder, the particle size of the Zn powder is 75 μm, and the purity is above 99.5%): 0.5%, Zr (Zr powder, the Zr powder The particle size is 100 μm, the purity is more than 99.5%): 0.5%, and the balance is Mg (magnesium powder, the particle size of Mg powder is 150 μm, and the purity is more than 99.5%).
本实施例中，含有Sr和Zn的WE43镁合金医用接骨板的制备方法包括以下步骤：In this embodiment, the preparation method of the WE43 magnesium alloy medical bone plate containing Sr and Zn comprises the following steps:
①称取原料：根据上述的质量百分比称取原料；① Weighing raw materials: Weighing raw materials according to the above mass percentage;
②混料球磨：取步骤①称取的Mg、Y、RE、Sr、Zn和Zr原料，干燥后放入球磨罐中进行球磨混合成混合料，其中，球磨机转速160r/min，球磨时间为10h；② Mixing ball milling: Take the Mg, Y, RE, Sr, Zn and Zr raw materials weighed in step ①, put them into a ball milling tank after drying, and ball mill them to form a mixture. The speed of the ball mill is 160r/min, and the ball milling time is 10h ;
③室温压制成型：将步骤②中所述混合料在室温下放到模具中进行压制成型，得到骨板坯料，其中，压制成型的压力为40MPa。③Compressing at room temperature: put the mixture described in step ② into a mold at room temperature for compression molding to obtain a bone plate blank, wherein the compression molding pressure is 40MPa.
④热压烧结：将步骤③中压制成型的骨板坯料放置于相同尺寸规格的模具中，将模具放置于氮气保护氛围的热压烧结炉中进行烧结，烧结的条件为：先升温至200℃，保温0.5h；再升温到650℃，保温1h，压力始终控制在40MPa。④Hot-press sintering: Place the bone plate blank pressed and formed in step ③ into a mold of the same size and specification, and place the mold in a hot-press sintering furnace with nitrogen protection atmosphere for sintering. The sintering conditions are: first raise the temperature to 200°C , keep warm for 0.5h; then raise the temperature to 650°C, keep warm for 1h, and the pressure is always controlled at 40MPa.
⑤热处理及冷却：将经过步骤④烧结后的医用骨板脱模取出后加热到300℃，保温5h，后冷却至室温即得含有Sr和Zn的WE43镁合金医用齿型接骨板。⑤Heat treatment and cooling: take out the medical bone plate sintered in step ④, take it out, heat it to 300°C, keep it warm for 5 hours, and then cool it to room temperature to get the WE43 magnesium alloy medical tooth bone plate containing Sr and Zn.
实施例2Example 2
一种含有Sr和Zn的WE43镁合金医用接骨板，由以下质量百分比的原料采用热压烧结工艺成型，A WE43 magnesium alloy medical bone plate containing Sr and Zn is formed by a hot pressing sintering process from the following mass percentage raw materials,
Y(钇)：4％，RE(稀土)：3％，Sr(锶)：1％，Zn(锌)：1％，Zr(锆)：0.5％，余量为Mg(镁)。Y (yttrium): 4%, RE (rare earth): 3%, Sr (strontium): 1%, Zn (zinc): 1%, Zr (zirconium): 0.5%, and the balance is Mg (magnesium).
制备方法同实施例1。The preparation method is the same as in Example 1.
实施例3Example 3
一种含有Sr和Zn的WE43镁合金医用接骨板，由以下质量百分比的原料采用热压烧结工艺成型，A WE43 magnesium alloy medical bone plate containing Sr and Zn is formed by a hot pressing sintering process from the following mass percentage raw materials,
Y(钇)：4％，RE(稀土)：3％，Sr(锶)：2％，Zn(锌)：2％，Zr(锆)：0.5％，余量为Mg(镁)。Y (yttrium): 4%, RE (rare earth): 3%, Sr (strontium): 2%, Zn (zinc): 2%, Zr (zirconium): 0.5%, and the balance is Mg (magnesium).
制备方法同实施例1。The preparation method is the same as in Example 1.
具体见下表1。See Table 1 below for details.
表1实施例所用合金的成分(质量百分含量wt％)The composition (mass percentage composition wt %) of the alloy used in the embodiment of table 1
耐腐蚀性能测试：根据国标GB/T10125-1997，对上述制成的实施例1、实施例2和实施例3的医用接骨板进行标准中性盐雾试验，得出性能数据见表2。Corrosion resistance test: According to the national standard GB/T10125-1997, the standard neutral salt spray test was carried out on the medical bone plates prepared above in Examples 1, 2 and 3, and the performance data are shown in Table 2.
表2医用齿型骨板的耐盐雾腐蚀性能Table 2 Salt spray corrosion resistance of medical tooth-shaped bone plates
由表2中可见，当合金成分在本发明所规定的成分范围内时，其耐腐蚀性能优异，其中，实施例2中的Mg-4％Y-3％RE-1％Sr-1％Zn-0.5％Zr医用接骨板耐腐蚀性能最好。As can be seen from Table 2, when the alloy composition is within the composition range specified by the present invention, its corrosion resistance is excellent, wherein, Mg-4%Y-3%RE-1%Sr-1%Zn in Example 2 -0.5% Zr medical bone plate has the best corrosion resistance.
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