CN113413251B - 一种3d打印的个体化髋臼精准定位手术导板 - Google Patents

一种3d打印的个体化髋臼精准定位手术导板 Download PDF

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CN113413251B
CN113413251B CN202110805011.7A CN202110805011A CN113413251B CN 113413251 B CN113413251 B CN 113413251B CN 202110805011 A CN202110805011 A CN 202110805011A CN 113413251 B CN113413251 B CN 113413251B
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CN113413251A (zh
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黄东骅
林秾
徐恺成
陈泽昊
叶招明
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Beijing Chunlizhengda Medical Instruments Co Ltd
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Zhejiang University ZJU
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Abstract

本发明公开了一种3D打印的个体化髋臼精准定位手术导板,所述的手术导板包括头部、体部和尾部;所述头部包括上、下两部分,上部为与组配式髋臼假体髋臼杯组件大小匹配的半球形第一引导单元,下部为圆形板状第二引导单元,所述第二引导单元的直径大于第一引导单元,用于确定原生髋臼的前倾外展角;所述体部用于连接头部和尾部,其形状可根据患者实际骨盆长度及具体手术规划调整;所述的尾部为一可固定于患者残留髂骨的固定单元。本发明的手术导板不仅能实现骨盆恶性肿瘤患者行内半骨盆切除术后组配式髋臼假体的精准定位,保留原生髋关节的前倾外展角,改善患者预后,且成本较低,操作简单,具备两种固定方式,可根据患者实际情况选择使用。

Description

一种3D打印的个体化髋臼精准定位手术导板
技术领域
本发明涉及骨科手术治疗领域,更具体地说,它涉及一种3D打印的个体化髋臼精准定位手术导板。
背景技术
3D打印技术,又称为快速成型技术,是一种根据CT扫描提供高质量射线成像数据,通过计算机技术辅助设计、制造,运用黏合性粉末材料以“层层叠加,层积成型”的方式快速精确地生成目标模型的新兴技术。近年来,3D打印技术愈发成熟,成本费用降低,其在医疗领域的应用日益增多,包括3D打印假体、3D打印手术导航模板等。
导航模板技术是采用3D打印技术设计、制备具有引导作用的骨面接触板,有助于外科医生在术中按照术前规划对植入假体的精准定位,正确匹配原生的解剖结构,降低手术风险和手术成功率,同时减少患者的术后并发症。为实现功能,导板通常需要2个模块,即利用人体固定解剖部位确定位置的模块和引导术者进行操作的模块。目前已有文献公开了多种3D打印的手术导板,广泛应用于口腔种植牙定位,复杂关节周围骨折,运动损伤等方面,但在骨盆肿瘤,尤其是髋臼周围的恶性肿瘤切除后术中重建方面研究甚少。
骨盆是恶性肿瘤,包括多种原发性恶性肿瘤(如骨肉瘤,软骨肉瘤,尤文肉瘤等)和转移性肿瘤(如肾癌,肺癌,乳腺癌,前列腺癌转移等)的好发部位之一。尤其是髋臼周围的恶性肿瘤,由于其解剖部位深且结构复杂,其治疗在骨肿瘤学界一直是一大难题。对于那些经历了骨盆肿瘤切除,遗留下髋臼周围广泛骨与软组织缺失的患者,术中重建恢复原生的髋关节旋转中心,使其能够稳定地发挥功能至关重要,与患者的预后密切相关。
传统的重建方式通常直接凭借外科医生的手术经验,大致估计患侧髋臼的位置和倾角,直接安放组配式髋臼假体。有研究将切除的半盆腔标本装入无菌塑料袋中,重新将其原位回植进行比对,来确定目标髋臼的位置,这种方式虽然简单,但操作过程中只能对盆腔的目标区域进行粗略估计,不确定性较大,且只适用于肿瘤整块切除的患者。也有文献报道在计算机导航技术的支持下重建“假想平面(ghost plane)”来还原髋臼的解剖位置及其外展角和前倾角,以此恢复髋关节旋转中心。这种方式被证明是切实有效、可重复应用的,但它需要昂贵的仪器设备,也需要操作人员前期大量的学习训练,此外延长的手术时间也增加了患者的手术风险。因此,设计发明一种易于操作的手术导板,使得内半骨盆切除术后组配式髋臼假体可以精准定位并保持原生的前倾外展角,对于改善骨盆恶性肿瘤患者的手术预后是十分必要的。
发明内容
为了克服现有髋关节重建技术操作成本高,手术时间长以及不确定性大等不足,本发明提供了一种3D打印的个体化髋臼精准定位手术导板,该手术导板不仅能实现骨盆恶性肿瘤患者行内半骨盆切除术后组配式髋臼假体的精准定位,保留原生髋关节的前倾外展角,改善患者预后,且成本较低,操作简单,具备两种固定方式,可根据患者实际情况选择使用。
本发明解决其技术问题所采用的技术方案是:
一种3D打印的个体化髋臼精准定位手术导板,包括头部、体部、尾部三个部分。其中所述头部又分为上、下两个部分,上部为与组配式髋臼假体髋臼杯组件大小匹配的半球形第一引导单元,下部为直径略大于上部的圆形板状第二引导单元,用于确定原生髋臼的前倾外展角。所述体部为一连接单元,用于连接头部和尾部,其形状可根据患者实际骨盆长度及具体手术规划调整。所述尾部为一可固定于患者残留髂骨的固定单元,所述尾部包括A、B两种样式,A样式包括若干固定通道,通过将克氏针打入固定通道并穿入髂骨,进而保证3D手术导板固定于髂骨嵴;B样式为卡扣式固定单元,所述的卡扣式固定单元还包括一位于前端的标记孔和一纵向贯穿固定单元的连接面,所述的标记孔用于确定手术导板定位于髂骨嵴上。
上述技术方案中,进一步地,所述手术导板由尼龙PA2200材料制备而成。
本发明还提供了一种3D打印的个体化髋臼精准定位手术导板的制备方法,包括以下步骤:
(1)使用螺旋CT扫描获得患者术前骨盆和股骨的解剖结构,具体的扫描参数为:120KV,140mAs,像素矩阵大小512×512,切片厚度1mm,层间间距1mm。
(2)将原始DICOM数据导入Arigin3d-Pro三维医学重建软件v5.0(中国上海新建医疗科技有限公司)中进行骨盆和股骨的三维重建。
(3)构建手术导板的头部:上部采用直径为44mm的半球形模块模拟髋臼内的部分股骨头,下部采用直径48mm的圆形板状模块模拟髋臼的前倾外展角。
(4)构建手术导板的尾部:调整骨盆三维重建模型至最佳解剖位置,建立仿真通道模块作为导板尾部,该模块需与髂骨嵴轮廓无缝拟合。
(5)构造手术导板的体部:导板体部可根据患者实际情况,设计不同的路径(直线、弧形、S型)连接导板的头部和尾部,以满足术中需求。
(6)根据软件构建导板的数据使用黏合材料打印导板,即得本发明3D打印的个体化髋臼精准定位手术导板。
通过采用上述技术方案,本发明手术导板在骨盆切除术后组配式髋臼假体重建过程中,根据三维重建数据确定精确位置,将导板尾部严密贴合于髂骨嵴,A样式将克氏针通过固定通道打入残留髂骨,B样式通过卡扣式结构固定。安装组配式髋臼假体,选择大小匹配的组配式髋臼假体髋臼杯组件扣于导板头部的第一引导单元上,并使杯缘与第二引导单元相吻合,确定髋臼假体的位置和外展前倾角。假体安装后拆除手术导板,A样式撤掉克氏针,B样式通过预留的连接面折断导板尾部即可。
本发明的有益效果是:
(1)手术导板是根据每一名患者骨盆肿瘤病灶的CT三维重建影像通过3D打印技术设计和制备得到,可实现治疗个体化与精准化。
(2)可根据患者实际病灶大小和手术切除范围,选择不同形状的的导板体部、A、B两种样式的导板尾部固定单元。
(3)术前制备好导板,相较于在术中使用计算机导航技术进行髋臼定位,可在术中快速定位节约手术时间,降低手术风险,减少术后并发症发生,减轻患者痛苦。
(4)根据三维结构构建的手术导板,较于传统的靠经验和手感定位极大地减少了不确定性,可以在术中精准定位原生髋臼的位置,并保留原有的前倾外展角,实现髋关节旋转中心的精确复位,有利于患者术后功能恢复。
附图说明:
图1:手术导板A样式正面结构示意图。
图2:手术导板B样式正面结构示意图。
图3:手术导板A样式背面结构示意图。
图4:手术导板B样式背面结构示意图。
图5:手术导板头部与组配式髋臼假体髋臼杯组件匹配示意图。
图6:手术导板A样式应用示例。
图7为手术导板B样式的尾部侧视图。
其中,尾部样式1A,尾部样式1B,固定通道2,体部3,第一引导单元4,第二引导单元5,组配式髋臼假体髋臼杯组件6,克氏针7,连接面8,标记孔9。
具体实施方式
实施例1:
一种3D打印的个体化髋臼精准定位手术导板,包括头部、体部3、尾部三个部分。其中所述头部又分为上、下两个部分,上部为与组配式髋臼假体髋臼杯组件大小匹配的半球形第一引导单元4,下部为直径略大于上部的圆形板状第二引导单元5,用于确定原生髋臼的前倾外展角。所述体部3用于连接导板的头部和尾部,其形状可根据患者实际骨盆长度及具体手术规划调整。所述尾部为一可固定于患者残留髂骨的固定单元,其中所述尾部包括A、B两种样式,尾部样式1A包括第一、第二、第三固定通道2,通过将克氏针7打入固定通道2并穿入髂骨,进而保证3D手术导板固定于髂骨嵴;尾部样式1B为卡扣式固定单元,所述卡扣式固定单元还包括一位于前端的标记孔9和一纵向贯穿固定单元的连接面8,所述的标记孔9用于确定手术导板定位于髂骨嵴上。
首先,通过以下步骤制备本发明3D打印的个体化髋臼精准定位手术导板:
(1)使用螺旋CT扫描获得患者术前骨盆和股骨的解剖结构,具体的扫描参数为:120KV,140mAs,像素矩阵大小512×512,切片厚度1mm,层间间距1mm。
(2)将原始DICOM数据导入Arigin3d-Pro三维医学重建软件v5.0(中国上海新建医疗科技有限公司)中进行骨盆和股骨的三维重建。
(3)构建手术导板的头部:上部采用直径为44mm的半球形模块模拟髋臼内的部分股骨头,下部采用直径48mm的圆形板状模块模拟髋臼的前倾外展角。
(4)构建手术导板的尾部:调整骨盆三维重建模型至最佳解剖位置,建立导板尾部,尾部需与髂骨嵴轮廓无缝拟合。
(5)构造一个模块连接导板头部和尾部,即导板体部。
(6)根据软件构建导板的数据使用黏合材料打印导板,即得本发明3D打印的个体化髋臼精准定位手术导板。
手术导板材料使用尼龙PA2200,使用超声波喷雾系统清洗,术前通过高压蒸汽(121℃,30分钟)灭菌备用。
所有手术操作在患者全身麻醉下进行。患者采取侧卧位。手术切口起自会阴部耻骨联合,沿腹股沟和髂嵴,止于骶髂关节。自髂棘至大转子处进行第二切口,并沿股骨方向延伸到大腿中部。根据肿瘤的大小制作皮瓣,广泛暴露骨盆进行截骨。手术切缘严格符合肌肉骨骼肿瘤学会系统。根据肿瘤的范围在髂骨、耻骨和/或坐骨进行截骨术。
随后利用导板进行髋关节重建。安装导板尾部使其严密贴合于髂骨嵴。一旦尾部固定单元处于最佳位置且安装紧密,用电钻通过固定通道植入2-3根外部克氏针,将导板临时固定于骨盆之上。选择由具有可变长度套管的髂骨组件和髋臼杯组件构成的组配式髋臼假体,先将髂骨组件和髋臼杯组件安装与残余骨结构上,继而调整髂骨组件的长度和髋臼杯的前倾外展角,使髋臼杯组件与头部的第一引导单元4准确吻合,并抵于第二引导单元5之上。确定组配式髋臼假体最终位置后即可用电钻撤出克氏针,移除手术导板。最后常规放置股骨头假体,即完成髋关节复位重建过程。
常规放置引流管,持续静脉应用抗生素2周,术后引流总量小于50mL/天时即可移除引流管。为防止髋关节脱位,将患侧髋部活动范围限制在中立外展位4周,术后约8周在卧床休息后开始增加负重进行功能锻炼。
本发明中未涉及部分均与现有技术相同或可采用现有技术加以实现。本具体实施例仅仅是对本发明的解释,其并不是对本发明的限制,本领域技术人员在阅读完本说明书后可以根据需要对本实施例做出没有创造性贡献的修改,但只要在本发明的权利要求范围内都受到专利法的保护。

Claims (4)

1.一种3D打印的个体化髋臼精准定位手术导板,其特征在于,包括头部、体部和尾部;所述头部包括上、下两部分,上部为与组配式髋臼假体髋臼杯组件大小匹配的半球形第一引导单元,下部为圆形板状第二引导单元,所述第二引导单元的直径大于第一引导单元,用于确定原生髋臼的前倾外展角;所述体部用于连接头部和尾部,其形状可根据患者实际骨盆长度及具体手术规划调整;所述的尾部为一可固定于患者残留髂骨嵴的固定单元;
所述的手术导板的使用方法为:首先将所述手术导板的尾部固定于髂骨嵴上;安装组配式髋臼假体,选择大小匹配的组配式髋臼假体髋臼杯组件扣于所述头部的第一引导单元上,并使杯缘与第二引导单元相吻合,确定髋臼假体的位置和外展前倾角;假体安装后拆除手术导板。
2.根据权利要求1所述的3D打印的个体化髋臼精准定位手术导板,其特征在于,所述的尾部包括A、B两种样式,A样式的固定单元上设有固定通道,通过将克氏针打入固定通道并穿入髂骨,进而保证3D手术导板固定于髂骨嵴;B样式为卡扣式固定单元,所述的卡扣式固定单元还包括一位于前端的标记孔和一纵向贯穿固定单元的连接面,所述的标记孔用于确定手术导板定位于髂骨嵴上。
3.根据权利要求1所述的3D打印的个体化髋臼精准定位手术导板,其特征在于,所述手术导板由尼龙PA2200材料制备而成。
4.一种如权利要求1-3任一项所述的3D打印的个体化髋臼精准定位手术导板的制备方法,其特征在于,包括以下步骤:
(1)使用螺旋CT扫描获得患者术前骨盆和股骨的解剖结构,具体的扫描参数为:120KV,140mAs,像素矩阵大小512×512,切片厚度1mm,层间间距1mm;
(2)将原始DICOM数据导入Arigin3d-Pro三维医学重建软件中进行骨盆和股骨的三维重建;
(3)构建手术导板的头部:上部采用直径为44mm的半球形模块模拟髋臼内的部分股骨头,下部采用直径48mm的圆形板状模块模拟髋臼的前倾外展角;
(4)构建手术导板的尾部:调整骨盆三维重建模型至最佳解剖位置,建立手术导板的尾部,尾部需与髂骨嵴轮廓无缝拟合;
(5)构造手术导板的体部:所述手术导板的体部可根据患者实际情况,设计为直线、弧形或S型;
(6)根据软件构建的手术导板数据使用黏合材料打印导板,即得到所述3D打印的个体化髋臼精准定位手术导板。
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