CN107252366A - 一种人工关节金属外杯及其制备方法 - Google Patents

一种人工关节金属外杯及其制备方法 Download PDF

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CN107252366A
CN107252366A CN201710027177.4A CN201710027177A CN107252366A CN 107252366 A CN107252366 A CN 107252366A CN 201710027177 A CN201710027177 A CN 201710027177A CN 107252366 A CN107252366 A CN 107252366A
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outer cup
metal outer
joint prosthesis
prosthesis metal
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吴栋
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Jingwei Medical Equipment Manufacturing Shenzhen Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772—Apertures or holes, e.g. of circular cross section
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys

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Abstract

本发明公开了一种人工关节金属外杯的制备方法，包括：先采用各种加工方法在人工关节金属外杯本体上生成孔或槽，再采用增材制造技术在孔或槽内构建柱突、球突或其他立体形状。不仅有助于植入物与骨组织之间形成制锁作用，能够为新骨的长入提供理想的空间结构，有利于改善骨组织细胞的附着、增生能力，达到良好的骨结合，增强了人工关节金属外杯与自体组织的融合性，有利于人工关节金属外杯在人体中长期有效地发挥作用；而且力学性能优异，机械强度高，能够很好降低应力遮挡，保持有效力学支撑。

Description

一种人工关节金属外杯及其制备方法
技术领域
本发明涉及医疗器械技术领域，尤其涉及一种骨科植入物人工关节金属外杯及其制备方法。
背景技术
由疾病和创伤造成的人工关节疾病是临床上的常见病，也是骨科治疗的世界性难题之一，严重地影响着患者的生活质量。人工关节金属外杯是目前临床应用较为普遍的骨科用材料。人工关节金属外杯在骨科治疗中的广泛应用，显著改善了过去临床无法解决的问题并且植入成功率也已达到了相当满意的效果。现有的人工关节金属外杯要么采用增材制造技术在人工关节金属外杯本体上形成一定的粗糙面，要么采用减材制造技术在人工关节金属外杯本体上生成孔洞等结构，然而单纯采用增材制造技术或减材制造技术制备的人工关节金属外杯与骨骼之间的骨长入效果不好、融合不充分、长期固定效果不稳定，严重时造成手术失败或术后康复不良。
发明内容
本发明所要解决的技术问题是克服上述现有技术的缺陷，提供一种人工关节金属外杯及其制备方法，使人工关节金属外杯与患者骨质结合力强，有利于骨组织长入，可实现较优的生物学固定效果。
本发明所要解决的技术问题通过以下技术方案予以实现：
一种人工关节金属外杯的制备方法，包括：先采用各种加工方法在人工关节金属外杯本体上生成孔或槽，再采用增材制造技术在孔或槽内构建柱突、球突或其他立体形状。
进一步地，所述孔的孔径为50-10000μm，深为25-5000μm；所述槽的宽为50-10000μm，深为25-5000μm。
进一步地，所述柱突、球突或其他立体形状的高为2-6000μm，形成粗糙面，有利于成骨细胞的爬行与固定。
进一步地，所述增材制造技术为3D打印。
进一步地，所述人工关节金属外杯本体通过生物相容性的金属材料真空脱蜡铸造或锻造制成。
进一步地，在人工关节金属外杯本体与人体骨质长期接触部位的表面生成孔或槽。
本发明还提供一种人工关节金属外杯，采用所述的制备方法而制成。
本发明具有如下有益效果：
（1）本发明在人工关节金属外杯本体上先采用各种加工方法在人工关节金属外杯本体上生成孔或槽，再采用增材制造技术在孔或槽内构建柱突、球突或其他立体形状，结合了减材制造技术和增材制造技术的优点，相较于传统的仅采用减材制造技术生成孔洞，以及传统的仅采用增材制造技术形成粗糙面，人工关节金属外杯与骨结合的表面积增大5-10倍，不仅有助于人工关节金属外杯与骨组织之间形成制锁作用，能够为新骨的长入提供理想的空间结构，有利于改善骨组织细胞的附着、增生能力，达到良好的骨结合，增强了人工关节金属外杯与自体组织的融合性，有利于人工关节金属外杯在人体中长期有效地发挥作用；而且力学性能优异，机械强度高，能够很好降低应力遮挡，保持有效力学支撑。
（2）工序步骤简单、可控性强、操作简便。
附图说明
图1为本发明的俯视图；
图2为本发明的侧视图。
图中：1、人工关节金属外杯本体，2、孔，3、柱突。
具体实施方式
下面结合实施例对本发明进行详细的说明，实施例仅是本发明的优选实施方式，不是对本发明的限定。
本发明的人工关节金属外杯的制备方法中，先采用各种加工方法在人工关节金属外杯本体上生成孔或槽，再采用增材制造技术在孔或槽内构建柱突、球突或其他立体形状。
所述各种加工方法为本领域已知的任何可以在人工关节金属外杯本体上生成孔或槽的加工方法，例如铸造、锻造、激光熔融、酸腐蚀等。
所述增材制造技术优选但不限定为3D打印。
所述人工关节金属外杯本体优选但不限定为通过生物相容性的金属材料真空脱蜡铸造或锻造制成，其中生物相容性的金属材料优选但不限定为钛合金、钴铬合金，其中钛合金包括Ti-8Fe-8Ta-4Zr，Ti-8Fe-8Ta-4Zr相较于传统的钛合金，大大降低了弹性模量，可以获得在机械性质和生物相容性方面的优异结果。
实施例1
一种人工关节金属外杯，其制备方法包括：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体，然后采用激光熔融方法在所述人工关节金属外杯本体与人体骨质长期接触部位的表面上生成孔或槽，再采用3D打印在孔内构建柱突、球突或其他立体形状；该激光熔融方法采用现有技术，使孔的孔径为50μm，深为25μm，使槽的宽为50μm，深为25μm；该3d打印技术采用现有技术，使柱突、球突或其他立体形状的高为2μm。
实施例2
一种人工关节金属外杯，其制备方法包括：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体，然后采用激光熔融方法在所述人工关节金属外杯本体与人体骨质长期接触部位的表面上生成孔或槽，再采用3D打印在孔内构建柱突、球突或其他立体形状；该激光熔融方法采用现有技术，使孔的孔径为10000μm，深为5000μm，使槽的宽为10000μm，深为5000μm；该3d打印技术采用现有技术，使柱突、球突或其他立体形状的高为6000μm。
实施例3
一种人工关节金属外杯，其制备方法包括：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体，然后采用激光熔融方法在所述人工关节金属外杯本体与人体骨质长期接触部位的表面上生成孔或槽，再采用3D打印在孔内构建柱突、球突或其他立体形状；该激光熔融方法采用现有技术，使孔的孔径为1000μm，深为1000μm，使槽的宽为1000μm，深为3000μm；该3d打印技术采用现有技术，使柱突、球突或其他立体形状的高为500μm。
实施例4
一种人工关节金属外杯，其制备方法包括：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体，然后采用酸腐蚀方法在所述人工关节金属外杯本体与人体骨质长期接触部位的表面上生成孔或槽，再采用3D打印在孔内构建柱突、球突或其他立体形状；所述酸腐蚀操作为：人工关节金属外杯本体先用浓度为15%的氢氟酸处理5-60秒，然后用浓度为65%的硝酸在75℃下处理1-10分钟，再用浓度为36%的盐酸于70℃下处理1-5分钟，然后取出利用蒸馏水或去离子水进行清洗；所述孔的孔径为100-6000μm，深为500-3000μm；所述槽的宽为500-3000μm，深为100-2000μm，该3d打印技术采用现有技术，使柱突、球突或其他立体形状的高为2000μm。
对比例1
一种人工关节金属外杯，其制备方法为：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体。
对比例2
一种人工关节金属外杯，其制备方法包括：通过钛合金采用真空脱蜡铸造或锻造制造人工关节金属外杯本体，然后采用激光熔融方法在所述人工关节金属外杯本体与人体骨质长期接触部位的表面上生成多个孔；所述孔的孔径为50-10000μm，深为25-5000μm。
检测项目：
A.骨钙素生成测试
MC3T3-E1 成骨细胞来源于新生小鼠的颅骨，细胞培养基为 α-MEM 培养基，其中含有10％胎牛血清、100U/ml青/链霉素、0.05g/L 抗坏血酸和 10mmol/Lβ- 甘油磷酸钠。将实施例1-4和对比例1-2制备的骨科植入物分别放入 24 孔板，采用 70％乙醇灭菌过夜，用磷酸盐缓冲液 (PBS) 洗3次，并用紫外照射消毒2小时。实验在24孔板的每孔接种 105个细胞，保持温度为37℃、气氛中含 5％ CO2，继续培养14天后收集上清液，用骨钙素ELISA试剂盒检测上清液中骨钙素的含量。单位：ng/mL。
B.抗拉强度
根据GB/T 13810-2007，对实施例1-4和对比例1-2制备的人工关节金属外杯进行抗拉强度测试。单位：Rm/MPa。
以上所述实施例仅表达了本发明的实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制，但凡采用等同替换或等效变换的形式所获得的技术方案，均应落在本发明的保护范围之内。

Claims (5)

1.一种人工关节金属外杯的制备方法，其特征在于，包括：先采用各种加工方法在人工关节金属外杯本体上生成孔或槽，再采用增材制造技术在孔或槽内构建柱突、球突或其他立体形状。
2.如权利要求1所述的人工关节金属外杯的制备方法，其特征在于，所述孔的孔径为50-10000μm，深为25-5000μm；所述槽的宽为50-10000μm，深为25-5000μm。
3.如权利要求1所述的人工关节金属外杯的制备方法，其特征在于，所述柱突、球突或其他立体形状的高为2-6000μm。
4.如权利要求1所述的人工关节金属外杯的制备方法，其特征在于，所述人工关节金属外杯本体通过生物相容性的金属材料真空脱蜡铸造或锻造制成。
5.一种人工关节金属外杯，采用权利要求1-4任一项所述的制备方法制成。
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