CN107841655A - 一种医用义肢的制备方法 - Google Patents

一种医用义肢的制备方法 Download PDF

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CN107841655A
CN107841655A CN201711017569.9A CN201711017569A CN107841655A CN 107841655 A CN107841655 A CN 107841655A CN 201711017569 A CN201711017569 A CN 201711017569A CN 107841655 A CN107841655 A CN 107841655A
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孙均衡
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
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    • A61LMETHODS 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
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B22CASTING; POWDER METALLURGY
    • B22CFOUNDRY MOULDING
    • B22C9/00Moulds or cores; Moulding processes
    • B22C9/02Sand moulds or like moulds for shaped castings
    • B22C9/04Use of lost patterns
    • CCHEMISTRY; METALLURGY
    • C22METALLURGY; FERROUS OR NON-FERROUS ALLOYS; TREATMENT OF ALLOYS OR NON-FERROUS METALS
    • C22CALLOYS
    • C22C14/00Alloys based on titanium

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Abstract

本发明公开了一种医用义肢的制备方法,选择如下的合金材料配方:Nb:2%,Cu:2%‑3%,Fe:9%,Mo:3%‑4%,Mn:1%~2%,Zr:3.5%,Cr:2.5%‑3.5%,Ca:1.5%‑2.5%,C:0.1%以下,余量为Ti;通过熔炼、蜡模制备与组合、模壳制备、浇注、热处理、精加工的步骤得到,本发明制得的义肢的强度远大于医用纯钛材料,对人体内部环境友好,密度低,具有良好的熔炼、烧结加工性能,力学性质接近人骨,耐疲劳、耐腐蚀性能好。

Description

一种医用义肢的制备方法
技术领域
本发明属于医疗卫生领域,尤其是涉及一种医用义肢的制备方法。
背景技术
随着现代医学与材料学的发展,医用假肢、人工关节、骨固定器,牙齿植入物,心脏瓣膜罩等用于制造植入人体内的医疗器件、假体或人工器官和辅助治疗设备在医疗卫生领域的应用日益广泛,上述部件的材料在生物相容性、强度、塑性、耐腐蚀性方面有了长足的发展。此前在在医学领域中广泛使用的医用合金有Ni-Cr系、Co系,Ti系等,其中Ti系的Ti-6Al-4V合金是应用最广泛的医用合金,但近年来发现,Ti-6Al-4V合金在使用中会析出极微量的钒和铝离子,其中析出的钒离子有毒性会引起不利的组织反应,铝离子会引起人体神经紊乱,降低细胞适应性等对人体造成危害的缺陷,目前主要的解决方法是通过表面涂层与其它处理技术在一定程度上阻止钒、铝等有毒元素离子的析出,但该方法的主要问题在于:增加了加工工序的复杂性,提高了成本,并且仍会有一部分钒、铝有毒元素析出,可靠性不能得到保证。
发明内容
有鉴于此,本发明提供了一种医用义肢的制备方法,其具有良好的强度、塑性、耐腐蚀性,并且无毒害,具有良好的生物相容性。
本发明完整的技术方案为:
一种医用义肢的制备方法,其特征在于,包括如下步骤:
(1)合金熔炼:
选择如下组分的合金:Nb:2%,Cu:2%-3%,Fe:9%,Mo:3%-4%,Mn:1%~2%,Zr:3.5%,Cr:2.5%-3.5%,Ca:1.5%-2.5%,C:0.1%以下,余量为Ti;
采用真空自耗电弧凝壳熔炼方式熔炼成40Kg的铸锭;熔炼电流为8000A,电压为30V,真空度为10-2Pa,切割成所需重量的合金块,清洗、烘干后备用;
(2)蜡模制备与组合
利用制蜡模机制作义肢蜡模,制模室温度为35-40℃,压注温度为55-65℃,压型温度为25-30℃,压注压力为1.8-2MPa,保压时间为2s,所用模具为不锈钢模具;
开模取出蜡模后,与浇注***粘接成蜡模组,一套浇注***连接8个义肢蜡模;
(3)模壳制备
利用步骤(2)所制得的蜡模组制备模壳,采用硅酸乙酯作为粘结剂,其中面砂为100号筛硅砂,二层采用60号筛高岭石熟料,背层采用20号筛高岭石熟料,封浆;蒸汽脱蜡后得到模壳;
(4)浇注
在真空感应熔炼炉中,将步骤(1)制备的合金块加入到坩埚中,抽真空到10-3-10- 4Pa,吹入氩气保护,加载功率至300-350KW至合金材料完全融化,保温5-10分钟,随后翻转坩埚,倒入步骤(3)所制备的模壳中,其中浇注时所述模壳为倾斜放置,倾斜角度为10°-15°。中,浇注温度为1520℃-1700℃,浇注时间为80-120s,冒口与铸件的重量比为0.3:1;保温到400℃后破真空取出;
(5)热处理
采用高压水力清砂的方法清除模壳,对得到的铸件进行热处理;
(6)精加工
对热处理后的铸件进行喷砂表面处理,对缺陷部位进行焊补后,得到所述的义肢。
本发明相对于现有技术的优点为:
合金成分科学,Zr元素增加了合金的生物相容性,并且合理的合金成分设置,使得组分之间形成稳定的结合,该合金材料制得的骨板或接骨钉在人体内部环境中,Cu、Cr等金属离子不会析出,对人体无害,具有非常良好的生物相容性。Mn、Fe、Mo、Nb等元素在Ti合金中以固溶形式存在,起到固溶强化的作用,Fe等元素降低了Ti合金的熔点,有利于烧结或熔炼,Ca,C、Cr、Cu、Fe、C显著增加了合金的耐腐蚀性,该材料的强度远大于医用纯钛材料,对人体内部环境友好,密度低,具有良好的熔炼、烧结加工性能,力学性质接近人骨,耐疲劳、耐腐蚀性能好。
具体实施方式
下面结合具体实施方式对本发明做进一步说明。
一种医用义肢的制备方法,其特征在于,包括如下步骤:
(1)合金熔炼:
选择如下组分的合金:Nb:2%,Cu:2%-3%,Fe:9%,Mo:3%-4%,Mn:1%~2%,Zr:3.5%,Cr:2.5%-3.5%,Ca:1.5%-2.5%,C:0.1%以下,余量为Ti;
采用真空自耗电弧凝壳熔炼方式熔炼成40Kg的铸锭;熔炼电流为8000A,电压为30V,真空度为10-2Pa,切割成所需重量的合金块,清洗、烘干后备用;
(2)蜡模制备与组合
利用制蜡模机制作义肢蜡模,制模室温度为35-40℃,压注温度为55-65℃,压型温度为25-30℃,压注压力为1.8-2MPa,保压时间为2s,所用模具为不锈钢模具;
开模取出蜡模后,与浇注***粘接成蜡模组,一套浇注***连接8个义肢蜡模;
(3)模壳制备
利用步骤(2)所制得的蜡模组制备模壳,采用硅酸乙酯作为粘结剂,其中面砂为100号筛硅砂,二层采用60号筛高岭石熟料,背层采用20号筛高岭石熟料,封浆;蒸汽脱蜡后得到模壳;
(4)浇注
在真空感应熔炼炉中,将步骤(1)制备的合金块加入到坩埚中,抽真空到10-3-10- 4Pa,吹入氩气保护,加载功率至300-350KW至合金材料完全融化,保温5-10分钟,随后翻转坩埚,倒入步骤(3)所制备的模壳中,其中浇注时所述模壳为倾斜放置,倾斜角度为10°-15°。中,浇注温度为1520℃-1700℃,浇注时间为80-120s,冒口与铸件的重量比为0.3:1;保温到400℃后破真空取出;
(5)热处理
采用高压水力清砂的方法清除模壳,对得到的铸件进行热处理;
(6)精加工
对热处理后的铸件进行喷砂表面处理,对缺陷部位进行焊补后,得到所述的义肢。

Claims (1)

1.一种医用义肢的制备方法,其特征在于,包括如下步骤:
(1)合金熔炼:
选择如下组分的合金:Nb:2%,Cu:2%-3%,Fe:9%,Mo:3%-4%,Mn:1%~2%,Zr:3.5%,Cr:2.5%-3.5%,Ca:1.5%-2.5%,C:0.1%以下,余量为Ti;
采用真空自耗电弧凝壳熔炼方式熔炼成40Kg的铸锭;熔炼电流为8000A,电压为30V,真空度为10-2Pa,切割成所需重量的合金块,清洗、烘干后备用;
(2)蜡模制备与组合
利用制蜡模机制作义肢蜡模,制模室温度为35-40℃,压注温度为55-65℃,压型温度为25-30℃,压注压力为1.8-2MPa,保压时间为2s,所用模具为不锈钢模具;
开模取出蜡模后,与浇注***粘接成蜡模组,一套浇注***连接8个义肢蜡模;
(3)模壳制备
利用步骤(2)所制得的蜡模组制备模壳,采用硅酸乙酯作为粘结剂,其中面砂为100号筛硅砂,二层采用60号筛高岭石熟料,背层采用20号筛高岭石熟料,封浆;蒸汽脱蜡后得到模壳;
(4)浇注
在真空感应熔炼炉中,将步骤(1)制备的合金块加入到坩埚中,抽真空到10-3-10-4Pa,吹入氩气保护,加载功率至300-350KW至合金材料完全融化,保温5-10分钟,随后翻转坩埚,倒入步骤(3)所制备的模壳中,其中浇注时所述模壳为倾斜放置,倾斜角度为10°-15°。中,浇注温度为1520℃-1700℃,浇注时间为80-120s,冒口与铸件的重量比为0.3:1;保温到400℃后破真空取出;
(5)热处理
采用高压水力清砂的方法清除模壳,对得到的铸件进行热处理;
(6)精加工
对热处理后的铸件进行喷砂表面处理,对缺陷部位进行焊补后,得到所述的义肢。
CN201711017569.9A 2017-10-26 2017-10-26 一种医用义肢的制备方法 Pending CN107841655A (zh)

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109079147A (zh) * 2018-10-11 2018-12-25 宝鸡文理学院 一种钛基生物合金材料的制备方法
CN113559332A (zh) * 2021-05-31 2021-10-29 南通大学 一种多维多分叉微孔高分子神经移植物导管的制备方法

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109079147A (zh) * 2018-10-11 2018-12-25 宝鸡文理学院 一种钛基生物合金材料的制备方法
CN109079147B (zh) * 2018-10-11 2021-09-24 宝鸡文理学院 一种钛基生物合金材料的制备方法
CN113559332A (zh) * 2021-05-31 2021-10-29 南通大学 一种多维多分叉微孔高分子神经移植物导管的制备方法

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