CN111281617B - 一种3d打印假体及应用 - Google Patents

一种3d打印假体及应用 Download PDF

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CN111281617B
CN111281617B CN202010168232.3A CN202010168232A CN111281617B CN 111281617 B CN111281617 B CN 111281617B CN 202010168232 A CN202010168232 A CN 202010168232A CN 111281617 B CN111281617 B CN 111281617B
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prosthesis
coating
bone
printed
inner coating
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CN111281617A (zh
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史春宝
许奎雪
卢小强
王振国
何建民
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Xingtai Langtai Benyuan Medical Instrument Co ltd
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Beijing Chunlizhengda Medical Instruments Co Ltd
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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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    • 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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Abstract

本发明涉及医疗器械技术领域，提供了一种3D打印假体及应用。包括基体和涂层，其中，所述基体的表面设有凹陷区；所述涂层包括3D打印的内涂层和外涂层，所述内涂层设于所述凹陷区，所述内涂层的厚度等于所述凹陷区的深度，所述外涂层设于所述内涂层的表面，所述外涂层为锯齿状结构。本发明的有益效果在于：3D打印的骨小梁结构与传统骨小梁结构不同，更有利于骨长入及假体的中长期稳定的作用；3D打印骨小梁结构分为两层，内层为网格骨小梁结构，保留原有优势，外层锯齿状结构，增大接触面积，提高摩擦力，防止假体滑脱，利于提高假体植入前期的稳定性。

Description

一种3D打印假体及应用
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3D打印假体及应用其的股骨柄和髓针假体。
背景技术
激光熔覆技术的发明为医疗器械行业加工技术带来了质的变化，把很多不可能变成了可能，把诸多困难变得简单。近年来，激光熔覆技术迅猛发展，但是在医疗行业处于空白，相信在不久的将来，激光熔覆技术就会应用到医疗器械行业。激光熔覆技术可以在不同材质的基体上进行熔覆，而且熔覆的粉末材质也可以多种多样，可以适用于人体的不同部位，适用性非常强。
人体骨小梁结构是骨皮质在松质骨内的延伸部分，在骨髓腔内呈不规则立体网格结构，起支持造血组织的作用。人体骨小梁同一位置为不均匀网格结构，不同位置结构有很大区别，同一位置不同身体状态下骨小梁结构也不相同，且人体骨小梁有拉力骨小梁和压力骨小梁之分。人体自然骨小梁结构是人类进化的结果，有深刻的生物力学原因以及细胞长入的原因。
研究表面，高的骨小梁孔隙率和联通性可以提高骨的生成水平，孔径为300-400μm时最适合骨长入，孔径为100-200μm时骨长入最快，梯度多级孔对骨髓干细胞的分化、软组织的再生有积极作用，粗糙多孔表面能很好的诱导产生异位骨，可以提高成骨细胞的粘附、增值、分化能力。研究表面，内固定微动范围小于28μm可以满足生物固定骨长入的要求，微动大于150μm时，则会在假体与骨界面产生软组织膜，影响固定效果。宏观尺度上的表面粗糙度，可以大大降低微动，利于骨长入。
股骨柄是髋关节置换必备的假体，在现代髋关节置换中已经很常见，一般采用锻造钛合金经过机加工工艺而成。股骨柄一般有水泥型和生物型，生物型股骨柄假体一般在采用表面喷砂、喷钛、喷HA或者喷钛+HA等方式，增加粗糙度并形成微孔，以便实现骨长上。髓针一般用于长骨骨干假体中，用于保持关节假体的稳定。其表面形式与股骨柄类似。现有的涂层一般在附着于假体表面，厚度只有几十微米，只能满足骨长上的要求，不能达到骨长入的要求，中长期稳定性不够好，且粘结强度低，容易脱落，脱落物会对人体造成感染的危害，且假体容易松动，需要进行二次手术。
发明内容
本发明的目的在于提供一种3D打印假体及应用，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3D打印假体，包括基体和涂层，其中，所述基体的表面设有凹陷区；所述涂层包括3D打印的内涂层和外涂层，所述内涂层设于所述凹陷区，所述内涂层的厚度等于所述凹陷区的深度，所述外涂层设于所述内涂层的表面，所述外涂层为锯齿状结构。
可选实施例中，所述内涂层为骨小梁结构，所述骨小梁结构的网格孔隙率为50％～80％，孔径设置为100～400μm，厚度为0.5-1mm。
可选实施例中，所述外涂层为骨小梁结构，所述锯齿状结构的锯齿长短不一，不均匀地分布在所述内涂层表面，所述锯齿的长度为0.5-1mm，所述锯齿与所述内涂层表面的夹角度数为30°到60°。
可选实施例中，所述凹陷区的深度为1.5-2mm。
可选实施例中，所述内涂层的厚度为1.5-2mm。
可选实施例中，所述基体为采用锻造工艺生产的钛合金。
另一方面，本发明还提供了一种股骨柄假体，包括如上所述的3D打印假体。
另一方面，本发明还提供了一种髓针假体，包括如上所述的3D打印假体。
本发明的有益效果在于：
(1)本发明3D打印结构中的3D打印的骨小梁结构与传统骨小梁结构不同，更有利于骨长入及假体的中长期稳定的作用。3D打印骨小梁结构分为两层，内层为网格骨小梁结构，保留原有优势，外层锯齿状结构，增大接触面积，提高摩擦力，防止假体滑脱，利于提高假体植入前期的稳定性。
(2)本发明中的3D打印假体中的基体是由锻造钛合金机加工而成，疲劳强度高。
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具有3D打印假体的股骨柄假体结构示意图。
图2为本发明一实施例提供的具有3D打印假体的髓针假体结构示意图。
图3为本发明一实施例提供的表面3D打印的涂层放大结构示意图。
其中，图中附图标记为：1、股骨柄假体，2、网装骨小梁，3、锯齿状骨小梁，4、髓针假体。
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、3，本实施例的目的在于提供了一种具有表面3D打印结构的股骨柄假体1，表面3D打印结构包括基体和涂层，基体为采用锻造工艺生产的钛合金，其具有密度与人骨相近、重量轻、弹性模量较低、机械强度高、抗疲劳性及耐腐蚀性高等优点。其中，基体的表面设有凹陷区，优选地，凹陷区的深度为1.5-2mm；涂层包括3D打印的内涂层和外涂层，内涂层设于凹陷区，内涂层的厚度等于凹陷区的厚度，优选地，内涂层的厚度为1.5-2mm。
需要指出的是，内涂层为网状骨小梁2，网状骨小梁2的网格孔隙率为50％～80％，孔径设置为100～400μm，厚度为0.5-1mm，表面3D打印骨小梁区域厚度合适，且粘附力强，利于骨长入，且涂层强度更好，利于假体的中长期稳定。外涂层设于所述内涂层的表面，外涂层为锯齿状骨小梁3，锯齿状骨小梁3的锯齿长短不一，不均匀地分布在内涂层表面，锯齿的长度为0.5-1mm，锯齿与内涂层表面的夹角度数为30°到60°，带倾斜角度的锯齿状骨小梁3利于假体的顺利植入并且起到阻止假体脱出的作用。
值得一提的是，股骨柄假体1中的骨小梁结构可以增加假体表面与人骨表面的接触面积，增大摩擦力，防止假体滑脱，可以实现良好的生物固定。
实施例二
请参阅附图2、3，本实施例的目的在于提供了一种具有表面3D打印结构的髓针假体4，表面3D打印结构包括基体和涂层，基体为采用锻造工艺生产的钛合金，其具有密度与人骨相近、重量轻、弹性模量较低、机械强度高、抗疲劳性及耐腐蚀性高等优点。其中，基体的表面设有凹陷区，优选地，凹陷区的深度为1.5-2mm；涂层包括3D打印的内涂层和外涂层，内涂层设于凹陷区，内涂层的厚度等于凹陷区的厚度，优选地，内涂层的厚度为1.5-2mm。
需要指出的是，内涂层为网状骨小梁2，网状骨小梁2的网格孔隙率为50％～80％，孔径设置为100～400μm，厚度为0.5-1mm，表面3D打印骨小梁区域厚度合适，且粘附力强，利于骨长入，且涂层强度更好，利于假体的中长期稳定。外涂层设于所述内涂层的表面，外涂层为锯齿状骨小梁3，锯齿状骨小梁3的锯齿长短不一，不均匀地分布在内涂层表面，锯齿的长度为0.5-1mm，锯齿与内涂层表面的夹角度数为30°到60°，带倾斜角度的锯齿状骨小梁3利于假体的顺利植入并且起到阻止假体脱出的作用。
值得一提的是，髓针假体4中的骨小梁结构可以增加假体表面与人骨表面的接触面积，增大摩擦力，防止假体滑脱，可以实现良好的生物固定。
上述实施例中的3D打印技术优选为激光熔覆技术，激光熔覆技术可以将不同的粉末材质熔覆在非生物型假体的实体表面部分，从而将非生物型假体转变为生物型假体，解决非生物型假体依靠骨水泥所造成的不良影响。
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 (6)

1.一种3D打印假体，包括基体和涂层，其中，所述基体的表面设有凹陷区；
其特征在于：所述涂层包括3D打印的内涂层和外涂层，所述内涂层设于所述凹陷区，所述内涂层的厚度等于所述凹陷区的深度，所述外涂层设于所述内涂层的表面，所述外涂层为锯齿状结构；所述内涂层为骨小梁结构，所述骨小梁结构的网格孔隙率为50％～80％，孔径设置为100～400μm，厚度为0.5-1mm；所述外涂层为骨小梁结构，所述锯齿状结构的锯齿长短不一，不均匀地分布在所述内涂层表面，所述锯齿的长度为0.5-1mm，所述锯齿与所述内涂层表面的夹角度数为30°到60°。
2.如权利要求1所述的3D打印假体，其特征在于，所述凹陷区的深度为1.5-2mm。
3.如权利要求2所述的3D打印假体，其特征在于，所述内涂层的厚度为1.5-2mm。
4.如权利要求1所述的3D打印假体，其特征在于，所述基体为采用锻造工艺生产的钛合金。
5.一种股骨柄假体，包括如权利要求1-4任意一项所述的3D打印假体。
6.一种髓针假体，包括如权利要求1-4任意一项所述的3D打印假体。
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