CN111374802B - 一种表面3d打印髋臼外杯假体 - Google Patents
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Abstract
本发明涉及医疗器械技术领域,提供了一种表面3D打印髋臼外杯假体。包括:髋臼外杯基体,设置于所述髋臼外杯基体上部中心的凸台部位设有持杯器连接孔,所述持杯器连接孔的一侧设置有若干个钉孔,所述髋臼外杯基体还设有压配槽和卡槽,所述髋臼外杯基体的外表面设有凹陷区;所述髋臼外杯基体的外表面设有3D打印的涂层,所述涂层包括内涂层和外涂层,所述内涂层设于所述凹陷区中,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。本发明的有益效果在于:骨小梁结构孔径、丝径、孔隙率设置合理,利于骨长入,涂层强度高,利于假体中长期稳定,可增加假体表面与人骨表面的接触面积,防止假体滑脱。
Description
技术领域
本发明涉及医疗器械技术领域,更具体地说,是涉及一种表面3D打印髋臼外杯假体。
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。
研究表明,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。研究表明,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。
人工髋关节的置换手术,普遍使用表面涂层的生物型髋臼外杯,基体由锻造钛合金材料通过机加工制造而成,疲劳强度高,表面进行喷涂处理,在表面形成一层粗糙面。现在应用3D打印技术可以直接打印出表面设计为骨小梁结构的髋臼外杯,然后在通过机加工最终满足使用要求。在髋臼外杯表面进行喷涂处理,方式主要包括:钛涂层、羟基磷灰石涂层、钽涂层,使其表面形成微孔粗糙表面,诱导骨细胞的长入。但是,使用现有涂层技术喷涂后,涂层孔型结构不可控、孔径极小、孔隙率低,诱导骨细胞长入的效果有限;且涂层粘结强度低,容易脱落。
3D打印髋臼外杯,内部的实体结构和表面的骨小梁结构是一体成型,虽然表面骨小梁结构有利于骨长入,但是内部实体结构疲劳强度与锻造基体相比较差,使用寿命相对较低。传统的髋臼外杯,植入人体后,十年甚至更早就需要进行翻修手术。随着人们生活水平的提高,患者对假体性能的要求逐渐增加,为假体成型工艺的处理提出了很高的要求。现代材料学的发展以及3D打印特殊骨小梁工艺的革新,为髋臼外杯的高性能提供了足够的技术条件。
现有技术中主要存在如下缺陷:(1)假体表面喷涂后的涂层,涂层孔型结构不可控、孔径极小、孔隙率低,诱导骨细胞长入的效果有限。(2)假体表面喷涂后的涂层,涂层粘结强度低,容易脱落,脱落物容易导致微粒渗透使软组织变黑引发感染。(3)3D打印髋臼外杯,其内部的实体结构和表面的骨小梁结构是一体成型,虽然表面骨小梁结构有利于骨长入,但是内部实体结构疲劳强度与锻造基体相比较差,使用寿命相对较低。
发明内容
本发明的目的在于提供一种表面3D打印髋臼外杯假体,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:一种表面3D打印髋臼外杯假体,包括:髋臼外杯基体,设置于所述髋臼外杯基体上部中心的凸台部位设有持杯器连接孔,所述持杯器连接孔的一侧设置有若干个钉孔,所述髋臼外杯基体还设有压配槽和卡槽,所述髋臼外杯基体的外表面设有凹陷区;所述髋臼外杯基体的外表面设有3D打印的涂层,所述涂层包括内涂层和外涂层,所述内涂层设于所述凹陷区中,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,所述内涂层为网状骨小梁结构,所述网状骨小梁结构的网格孔隙率为50%~90%,孔径设置为100~400μm,厚度为0.5-1mm。
可选实施例中,所述外涂层为锯齿状骨小梁结构,所述锯齿状骨小梁结构的锯齿长短不一,不均匀地分布在所述内涂层的表面,所述锯齿的长度为0.5-1mm,所述锯齿与所述内涂层的表面夹角度数分别为90°。
可选实施例中,所述凹陷区的深度为0.5-1mm,与所述凸台的高度持平。
可选实施例中,开设于所述凸台处的所述持杯器连接孔的直径为10mm,所述持杯器连接孔内设有内螺纹。
可选实施例中,所述钉孔的数量为3个,所述钉孔的内部直径为8mm,所述钉孔的外部直径为6mm。
可选实施例中,所述压配槽为直径1-2mm的环形槽孔,所述卡槽为六方卡槽,共有12个,所述压配槽与所述卡槽作用,固定髋臼内衬。
可选实施例中,所述髋臼外杯基体为采用锻造工艺加工的钛合金。
可选实施例中,将纯钛粉末熔覆在所述髋臼外杯基体表面,采用3D打印技术加工所述内涂层和外涂层。
本发明的有益效果在于:
(1)本发明中髋臼外杯基体的表面3D打印的骨小梁结构孔径、丝径、孔隙率设置合理,有利于骨长入,且涂层强度高,利于假体的中长期稳定。现有的涂层孔型结构不可控、孔径极小、孔隙率低,诱导骨细胞长入的效果有限。
(2)本发明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。现有的骨小梁涂层粘结强度低,容易脱落,脱落物容易导致微粒渗透使软组织变黑引发感染。
(3)本发明中的髋臼外杯基体是由锻造钛合金机加工而成,疲劳强度高,使用寿命长。
(4)本发明中的凸台结构增大了持杯器连接孔的螺纹孔直径与高度,增加了螺纹圈数,提高了与持杯器配合使用的稳定性。
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表面3D打印髋臼外杯假体的内俯视图。
图2为本发明一实施例提供的表面3D打印髋臼外杯假体的骨小梁区域剖视图。
图3为本发明一实施例提供的表面3D打印髋臼外杯假体的内部剖视图。
其中,图中附图标记为:1、髋臼外杯基体,2、凸台,3、持杯器连接孔,4、钉孔,5、网状骨小梁结构,6、锯齿状骨小梁结构,7、涂层,8、压配槽,9、卡槽。
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表面3D打印髋臼外杯假体,包括:髋臼外杯基体1,髋臼外杯基体1为采用锻造工艺加工的钛合金,其具有密度与人骨相近、重量轻、弹性模量较低、内部实体强度高、抗疲劳性及耐腐蚀性高、使用寿命长等优点。
其中,髋臼外杯基体1上部中心的凸台2部位设有持杯器连接孔3,开设于凸台2处的持杯器连接孔的直径为10mm,持杯器连接孔3内设有内螺纹,需要指出的是,凸台2的结构增大了持杯器连接孔3的螺纹孔直径与高度,增加了螺纹圈数,提高了与持杯器配合使用的稳定性。持杯器连接孔3的一侧设置有若干个钉孔4,钉孔4的数量为3个,钉孔4的内部直径为8mm,钉孔4的外部直径为6mm。髋臼外杯基体1还设有压配槽8和卡槽9,压配槽8为直径1mm的环形槽孔,卡槽9为六方卡槽,共有12个,压配槽8与卡槽9作用,固定髋臼内衬。
具体地,髋臼外杯基体1的外表面设有凹陷区,凹陷区的深度为0.5mm,与凸台2的高度持平。髋臼外杯基体1的外表面设有3D打印的涂层7,涂层7包括内涂层和外涂层,将纯钛粉末熔覆在髋臼外杯基体1的表面,采用3D打印技术加工内涂层和外涂层,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。内涂层设于凹陷区中,内涂层的厚度等于凹陷区的深度,外涂层设于内涂层的表面,外涂层为锯齿状结构。本实施例中,内涂层为网状骨小梁结构5,网状骨小梁结构5的网格孔隙率为50%,孔径设置为100μm,厚度为0.5mm;外涂层为锯齿状骨小梁结构6,锯齿状骨小梁结构6的锯齿长短不一,不均匀地分布在内涂层的表面,锯齿的长度为0.5mm,锯齿与内涂层的表面夹角度数分别为90°,带倾斜角度的锯齿状骨小梁结构6利于髋臼外杯假体的顺利植入,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。值得一提的是,本实施例中的骨小梁结构6孔径、丝径、孔隙率设置合理,有利于骨长入,且涂层强度高,利于假体的中长期稳定。
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表面3D打印髋臼外杯假体,包括:髋臼外杯基体1,髋臼外杯基体1为采用锻造工艺加工的钛合金,其具有密度与人骨相近、重量轻、弹性模量较低、内部实体强度高、抗疲劳性及耐腐蚀性高、使用寿命长等优点。
其中,髋臼外杯基体1上部中心的凸台2部位设有持杯器连接孔3,开设于凸台2处的持杯器连接孔的直径为10mm,持杯器连接孔3内设有内螺纹,需要指出的是,凸台2的结构增大了持杯器连接孔3的螺纹孔直径与高度,增加了螺纹圈数,提高了与持杯器配合使用的稳定性。持杯器连接孔3的一侧设置有若干个钉孔4,钉孔4的数量为3个,钉孔4的内部直径为8mm,钉孔4的外部直径为6mm。髋臼外杯基体1还设有压配槽8和卡槽9,压配槽8为直径2mm的环形槽孔,卡槽9为六方卡槽,共有12个,压配槽8与卡槽9作用,固定髋臼内衬。
具体地,髋臼外杯基体1的外表面设有凹陷区,凹陷区的深度为1mm,与凸台2的高度持平。髋臼外杯基体1的外表面设有3D打印的涂层7,涂层7包括内涂层和外涂层,将纯钛粉末熔覆在髋臼外杯基体1的表面,采用3D打印技术加工内涂层和外涂层,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。内涂层设于凹陷区中,内涂层的厚度等于凹陷区的深度,外涂层设于内涂层的表面,外涂层为锯齿状结构。本实施例中,内涂层为网状骨小梁结构5,网状骨小梁结构5的网格孔隙率为90%,孔径设置为400μm,厚度为1mm;外涂层为锯齿状骨小梁结构6,锯齿状骨小梁结构6的锯齿长短不一,不均匀地分布在内涂层的表面,锯齿的长度为1mm,锯齿与内涂层的表面夹角度数分别为90°,带倾斜角度的锯齿状骨小梁结构6利于髋臼外杯假体的顺利植入,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。值得一提的是,本实施例中的骨小梁结构6孔径、丝径、孔隙率设置合理,有利于骨长入,且涂层强度高,利于假体的中长期稳定。
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 (5)
1.一种表面3D打印髋臼外杯假体,包括:髋臼外杯基体,设置于所述髋臼外杯基体上部中心的凸台处设有持杯器连接孔,所述持杯器连接孔的一侧设置有若干个钉孔,所述髋臼外杯基体还设有用于固定髋臼内衬的压配槽和卡槽,所述髋臼外杯基体的外表面设有凹陷区;
其特征在于:所述髋臼外杯基体的外表面设有3D打印的涂层,所述涂层包括内涂层和外涂层,所述内涂层设于所述凹陷区中,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;所述内涂层为网状骨小梁结构,所述网状骨小梁结构的网格孔隙率为50%~90%,孔径设置为100~400μm,厚度为0.5-1mm;所述外涂层为锯齿状骨小梁结构,所述锯齿状骨小梁结构的锯齿长短不一,不均匀地分布在所述内涂层的表面,所述锯齿的长度为0.5-1mm,所述锯齿与所述内涂层的表面夹角度数为90°。
2.如权利要求1所述的表面3D打印髋臼外杯假体,其特征在于,开设于所述凸台处的所述持杯器连接孔的直径为10mm,所述持杯器连接孔内设有内螺纹。
3.如权利要求1所述的表面3D打印髋臼外杯假体,其特征在于,所述钉孔的数量为3个。
4.如权利要求1所述的表面3D打印髋臼外杯假体,其特征在于,所述髋臼外杯基体为采用锻造工艺加工的钛合金。
5.如权利要求4所述的表面3D打印髋臼外杯假体,其特征在于,将纯钛粉末熔覆在所述髋臼外杯基体的外表面,采用3D打印技术加工所述内涂层和外涂层。
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