CN111603276A - 一种定制尺骨假体 - Google Patents

一种定制尺骨假体 Download PDF

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CN111603276A
CN111603276A CN202010445535.5A CN202010445535A CN111603276A CN 111603276 A CN111603276 A CN 111603276A CN 202010445535 A CN202010445535 A CN 202010445535A CN 111603276 A CN111603276 A CN 111603276A
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prosthesis
ulnar
bone
customized
broach
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史春宝
许奎雪
何建民
荀世界
李明洋
康树靖
王振国
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Beijing Chunlizhengda Medical Instruments Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3804Joints for elbows or knees for elbows
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2/30942Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30024Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in coefficient of friction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30772Apertures or holes, e.g. of circular cross section
    • A61F2002/30784Plurality of holes
    • AHUMAN NECESSITIES
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    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/38Joints for elbows or knees
    • A61F2/3804Joints for elbows or knees for elbows
    • A61F2002/3831Ulnar components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

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Abstract

本发明涉及医疗器械技术领域,提供了一种定制尺骨假体。包括:假体本体,所述假体本体的上端部设有鹰嘴沟,所述假体本体的下端部设有髓针;所述假体本体上还设有根据人体韧带附着点确定的若干缝合孔,若干所述缝合孔位于所述鹰嘴沟和所述髓针之间,所述假体本体表面的非缝合孔区域不均匀地设置有骨小梁结构。本发明的有益效果在于:尺骨假体的关节面光滑,特别是鹰嘴沟进行了抛光处理,降低了尺骨假体与人体肘关节面的磨损,延长了假体的使用寿命;尺骨假体中的多个缝合孔共同作用,保证了尺骨假体在人体中的前期稳定;尺骨假体中的骨小梁结构可以降低尺骨假体的整体重量,提高了骨附着、骨长入的能力。

Description

一种定制尺骨假体
技术领域
本发明涉及医疗器械技术领域,更具体地说,是涉及一种定制尺骨假体。
背景技术
现有技术中国专利申请CN110393613A中公开了一种肘关节假体。所述肘关节假体包括:肱骨假体,肱骨假体的连接端的相对的两侧上分别形成有沿远离肱骨假体的长度方向延伸出的第一凸耳和第二凸耳,第一凸耳上设置有第一通孔,第二凸耳上设置有与第一通孔同轴的第二通孔;尺骨假体,尺骨假体的与连接端相对的一端上设置有第三通孔;转轴组件,转轴组件包括转轴,转轴用于同时穿过第一通孔、第二通孔以及第三通孔,以将肱骨假体与尺骨假体转动连接。其中,转轴设置成能够沿转轴的轴向伸缩,以使转轴的第一端能够在初始状态下置入第一通孔后,转轴的第二端能够在压缩状态下置入第二通孔中。
但现有的技术中并没有尺骨肿瘤假体,且存在如下缺陷:(1)现有尺骨假体均为肘关节假体,对于尺骨肿瘤,不能保留肱骨远端,即不能做到单纯的尺骨置换;(2)现有肘关节假体依靠骨水泥固定髓针,中长期稳定性差,容易松动。
发明内容
本发明的目的在于提供一种定制尺骨假体,以解决现有技术中存在的技术问题。
为实现上述目的,本发明采用的技术方案是:一种定制尺骨假体,包括:假体本体,所述假体本体的上端部设有鹰嘴沟,所述假体本体的下端部设有髓针;所述假体本体上还设有根据人体韧带附着点确定的若干缝合孔,若干所述缝合孔位于所述鹰嘴沟和所述髓针之间,所述假体本体表面的非缝合孔区域不均匀地设置有骨小梁结构。
可选实施例中,所述假体本体的制作过程为:1)获取患者的病损尺骨关节的骨骼部分三维图像以及骨质边界;2)利用三维软件设计患者的感染尺骨关节的所述假体本体模型,还原尺骨形态,并保留关节面弧度;3)利用定制3D打印技术制作所述假体的内体毛胚,采用机加工完成所述假体本体的加工。
可选实施例中,所述缝合孔的数量根据所述人体韧带附着点的面积确定,若干所述缝合孔并排设置。
可选实施例中,所述缝合孔的数量为2-10个,所述缝合孔的直径为2-5mm。
可选实施例中,所述骨小梁结构包括假体本体骨小梁,所述假体本体骨小梁的上层为骨小梁,所述假体本体骨小梁的下层为钛合金实体,所述骨小梁的网格孔隙率为50%~80%,孔径为100~400μm,厚度为1-3mm。
可选实施例中,所述骨小梁结构还包括所述髓针的根部骨小梁,所述根部骨小梁的网格孔隙率为50%~80%,孔径为100~400μm,厚度为2-5mm。
可选实施例中,所述假体本体的材料为钛合金材质。
可选实施例中,所述鹰嘴沟抛光处理。
可选实施例中,所述髓针为仿生物型髓针;所述髓针的表面喷涂处理,经所述喷涂处理的所述髓针的表面具有钛涂层、羟基磷灰石涂层和钽涂层;经所述喷涂处理的所述髓针的表面为具有孔的粗糙表面。
本发明的有益效果在于:
(1)本发明中的尺骨假体以患者的病损尺骨关节的三维数据为依据定制设计,利用3D打印技术制作,保留了人体肱骨远端的部分,可以保留更多骨质。
(2)本发明中的尺骨假体的材料为钛合金材质,具有强度高、比重轻的特点。
(3)本发明中的尺骨假体的关节面光滑,特别是鹰嘴沟进行了抛光处理,降低了尺骨假体与人体肘关节面的磨损,延长了假体的使用寿命。
(4)本发明中的尺骨假体中的多组(个)缝合孔共同作用,保证了尺骨假体在人体中的前期稳定。
(5)本发明中的骨小梁结构可以降低尺骨假体的整体重量,提高了骨附着、骨长入的能力,尤其是能够提高截骨面骨的长入。
(6)本发明中的仿生物型髓针可以诱导骨细胞的长入,与传统的骨水泥固定相比,能够实现长期固定,且稳定性好。
附图说明
为了更清楚地说明本发明实施例中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其它的附图。
图1为本发明一实施例提供的定制尺骨假体的整体结构示意图一。
图2为本发明一实施例提供的定制尺骨假体的整体结构示意图二。
其中,图中附图标记为:1、鹰嘴沟,2、缝合孔,3、骨小梁结构,3-1、假体本体骨小梁,3-2、根部骨小梁,4、髓针。
具体实施方式
为了使本发明所要解决的技术问题、技术方案及有益效果更加清楚明白,以下结合附图及实施例,对本发明进行进一步详细说明。应当理解,此处所描述的具体实施例仅用以解释本发明,并不用于限定本发明。
需要说明的是,当部件被称为“固定于”或“设置于”另一个部件,它可以直接或者间接位于该另一个部件上。当一个部件被称为“连接于”另一个部件,它可以是直接或者间接连接至该另一个部件上。术语“上”、“下”、“左”、“右”、“前”、“后”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置为基于附图所示的方位或位置,仅是为了便于描述,不能理解为对本技术方案的限制。术语“第一”、“第二”仅用于便于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明技术特征的数量。“多个”的含义是两个或两个以上,除非另有明确具体的限定。
实施例一
请参阅附图1-2,本实施例的目的在于提供了一种定制尺骨假体,包括:假体本体,所述假体本体的材料为钛合金材质,具有强度高、比重轻的特点。假体本体的上端部设有鹰嘴沟1,鹰嘴沟1抛光处理,使尺骨假体的关节面光滑,降低了尺骨假体与人体肘关节面的磨损,延长了假体的使用寿命。假体本体的下端部设有髓针4,髓针4为仿生物型髓针;髓针4的表面喷涂处理,经喷涂处理的髓针4的表面具有钛涂层、羟基磷灰石涂层和钽涂层;经喷涂处理的髓针4的表面为具有孔的粗糙表面,该孔优选为微孔。仿生物型髓针可以诱导骨细胞的长入,与传统的骨水泥固定相比,能够实现长期固定,且稳定性好。
具体地,假体本体上还设有根据人体韧带附着点确定的若干缝合孔2,若干缝合孔2位于鹰嘴沟1和髓针4之间,缝合孔2的数量根据人体韧带附着点的面积确定,若干缝合孔2并排设置;缝合孔2的数量为6个,缝合孔2的直径为2mm。尺骨假体中的多个缝合孔2共同作用,保证了尺骨假体在人体中的前期稳定。
本实施例中,假体本体表面的非缝合孔2区域不均匀地设置有骨小梁结构3,骨小梁结构3包括假体本体骨小梁3-1,假体本体骨小梁3-1的上层为骨小梁,假体本体骨小梁3-1的下层为钛合金实体,骨小梁的网格孔隙率为50%,孔径为100μm,厚度为1mm;骨小梁结构3还包括髓针4的根部骨小梁3-2,根部骨小梁3-2的网格孔隙率为50%,孔径为100μm,厚度为2mm。骨小梁结构3可以降低尺骨假体的整体重量,提高了骨附着、骨长入的能力,尤其是能够提高截骨面骨的长入。
其中,所述假体本体的制作过程为:1)获取患者的病损尺骨关节的骨骼部分三维图像以及骨质边界;2)利用三维软件设计患者的感染尺骨关节的所述假体本体模型,还原尺骨形态,并保留关节面弧度;3)利用定制3D打印技术制作所述假体的内体毛胚,采用机加工完成所述假体本体的加工。需要指出的是,尺骨假体以患者的病损尺骨关节的三维数据为依据定制设计,利用3D打印技术制作,保留了人体肱骨远端的部分,可以保留更多骨质。
实施例二
请参阅附图1-2,本实施例的目的在于提供了一种定制尺骨假体,包括:假体本体,假体本体的材料为钛合金材质,具有强度高、比重轻的特点。假体本体的上端部设有鹰嘴沟1,鹰嘴沟1抛光处理,使尺骨假体的关节面光滑,降低了尺骨假体与人体肘关节面的磨损,延长了假体的使用寿命。假体本体的下端部设有髓针4,髓针4为仿生物型髓针;髓针4的表面喷涂处理,经喷涂处理的髓针4的表面具有钛涂层、羟基磷灰石涂层和钽涂层;经喷涂处理的髓针4的表面为具有孔的粗糙表面,该孔优选为微孔。仿生物型髓针可以诱导骨细胞的长入,与传统的骨水泥固定相比,能够实现长期固定,且稳定性好。
具体地,假体本体上还设有根据人体韧带附着点确定的若干缝合孔2,若干缝合孔2位于鹰嘴沟1和髓针4之间,缝合孔2的数量根据人体韧带附着点的面积确定,若干缝合孔2并排设置;缝合孔2的数量为10个,缝合孔2的直径为5mm。尺骨假体中的多个缝合孔2共同作用,保证了尺骨假体在人体中的前期稳定。
本实施例中,假体本体表面的非缝合孔2区域不均匀地设置有骨小梁结构3,骨小梁结构3包括假体本体骨小梁3-1,假体本体骨小梁3-1的上层为骨小梁,假体本体骨小梁3-1的下层为钛合金实体,骨小梁的网格孔隙率为80%,孔径为400μm,厚度为3mm;骨小梁结构3还包括髓针4的根部骨小梁3-2,根部骨小梁3-2的网格孔隙率为80%,孔径为400μm,厚度为5mm。骨小梁结构3可以降低尺骨假体的整体重量,提高了骨附着、骨长入的能力,尤其是能够提高截骨面骨的长入。
其中,所述假体本体的制作过程为:1)获取患者的病损尺骨关节的骨骼部分三维图像以及骨质边界;2)利用三维软件设计患者的感染尺骨关节的所述假体本体模型,还原尺骨形态,并保留关节面弧度;3)利用定制3D打印技术制作所述假体的内体毛胚,采用机加工完成所述假体本体的加工。需要指出的是,尺骨假体以患者的病损尺骨关节的三维数据为依据定制设计,利用3D打印技术制作,保留了人体肱骨远端的部分,可以保留更多骨质。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。

Claims (9)

1.一种定制尺骨假体,包括:假体本体,所述假体本体的上端部设有鹰嘴沟(1),所述假体本体的下端部设有髓针(4);
其特征在于,所述假体本体上还设有根据人体韧带附着点确定的若干缝合孔(2),若干所述缝合孔(2)位于所述鹰嘴沟(1)和所述髓针(4)之间,所述假体本体表面的非缝合孔(2)区域不均匀地设置有骨小梁结构(3)。
2.如权利要求1所述的定制尺骨假体,其特征在于,所述假体本体的制作过程为:1)获取患者的病损尺骨关节的骨骼部分三维图像以及骨质边界;2)利用三维软件设计患者的感染尺骨关节的所述假体本体模型,还原尺骨形态,并保留关节面弧度;3)利用定制3D打印技术制作所述假体的内体毛胚,采用机加工完成所述假体本体的加工。
3.如权利要求1所述的定制尺骨假体,其特征在于,所述缝合孔(2)的数量根据所述人体韧带附着点的面积确定,若干所述缝合孔(2)并排设置。
4.如权利要求3所述的定制尺骨假体,其特征在于,所述缝合孔(2)的数量为2-10个,所述缝合孔(2)的直径为2-5mm。
5.如权利要求1所述的定制尺骨假体,其特征在于,所述骨小梁结构(3)包括假体本体骨小梁(3-1),所述假体本体骨小梁(3-1)的上层为骨小梁,所述假体本体骨小梁(3-1)的下层为钛合金实体,所述骨小梁的网格孔隙率为50%~80%,孔径为100~400μm,厚度为1-3mm。
6.如权利要求5所述的定制尺骨假体,其特征在于,所述骨小梁结构(3)还包括所述髓针(4)的根部骨小梁(3-2),所述根部骨小梁(3-2)的网格孔隙率为50%~80%,孔径为100~400μm,厚度为2-5mm。
7.如权利要求1所述的定制尺骨假体,其特征在于,所述假体本体的材料为钛合金材质。
8.如权利要求1所述的定制尺骨假体,其特征在于,所述鹰嘴沟(1)抛光处理。
9.如权利要求1所述的定制尺骨假体,其特征在于,所述髓针(4)为仿生物型髓针;所述髓针(4)的表面喷涂处理,经所述喷涂处理的所述髓针(4)的表面具有钛涂层、羟基磷灰石涂层和钽涂层;经所述喷涂处理的所述髓针(4)的表面为具有孔的粗糙表面。
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