CN113413252A - 一种可塑性通用型髋臼精准定位手术导板 - Google Patents
一种可塑性通用型髋臼精准定位手术导板 Download PDFInfo
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Abstract
本发明公开了一种可塑性通用型髋臼精准定位手术导板，所述导板包括头部、体部和尾部；头部包括第一引导单元和第二引导单元，第一引导单元为与组配式髋臼假体髋臼杯组件大小匹配的半球形结构，第二引导单元为一直径大于第一引导单元的圆形板状结构；体部包括第一连接单元和第二连接单元；第一连接单元为一两端较宽中间较细的弧形可调节金属片，可根据实际需要进行塑形调节；第二连接单元为一侧包括若干圆柱形插槽的金属板；尾部为一独立的固定单元，固定单元为一块金属钢板，金属钢板上间隔排列有若干螺钉孔和若干圆柱形凸起。本发明能实现骨盆恶性肿瘤患者行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。
Description
技术领域
本发明涉及骨科手术治疗领域，更具体地说，涉及一种可塑性通用型髋臼精准定位手术导板。
背景技术
骨盆恶性肿瘤分为原发恶性骨盆骨肿瘤与转移瘤，前者多见软骨源性肿瘤(如软骨肉瘤等)，其中髂骨为好发部位，其次为髋臼周围；转移瘤主要来源于乳腺癌、肾癌等。骨盆肿瘤恶性率高且存在局部复发和转移倾向。此外，复杂的局部解剖结构，包括一些主要的血管神经结构及肠道、泌尿道等，使其在手术切除过程中存在较高的并发症风险。近十年来，随着影像技术、新辅助治疗、手术技术和新型假体制备技术的巨大进步，保肢手术逐渐取代传统的截肢术，成为骨盆肿瘤手术治疗的首选方案，以期在不影响安全肿瘤边界的前提下提高患者术后功能及生存质量。
除了肿瘤切除，准确进行术中髋关节重建也是一项巨大的挑战。目前常采用组配式人工髋臼假体来实现骨盆肿瘤切除后骨缺损区域的重建，最早是由我国北京大学人民医院郭卫教授等率先设计并成功应用，包括具有可变长度套管的髂骨组件和髋臼杯组件两部分。组配式假体体积小便于软组织覆盖，术中操作简单且所需辅助设备要求低，可根据实际切除的骨盆范围临时组装完成缺损的重建，早期即可达到牢固固定。然而，广泛的骨盆切除术，尤其是累及髋臼周围和耻骨区域(Enneking Dunham's II+III区)的恶性肿瘤切除术后，由于骨量和解剖标志物的大量丢失，假体安装缺乏参照物，术中反复调整假体位置导致手术时间增长，增加感染和出血风险，偏离原始的髋关节旋转中心，也增加了术后患者假体松动，关节脱位，肢体长度差异等并发症发生风险。因此，如何在骨盆肿瘤切除术后精确定位髋臼位置使假体安装处于原位并保持原始的前倾外展角一直是骨科外科医生重点研究的问题之一。
传统的重建方式多依赖外科医生的手术经验，凭借操作过程中对盆腔目标区域及检测髋关节的粗略估计，或多次尝试不同规格的组配式髋臼假体实现重建。传统方法虽然简单，但不确定性较大。随着数字成像技术及3D打印技术的快速发展，近年来有文献报道在术中采用3D打印的手术导航模板实现髋臼的精准定位。3D打印的手术导板根据患者实际情况进行个体化治疗，提高手术效率，减少了并发症的发生，同时也避免了术中导航产生的辐射危害。然而，其同样存在一些不足。例如，3D打印的手术导板需要根据患者的实际情况定制，前期设计、制备时间长，成本高，但部分侵袭性骨盆恶性肿瘤往往进展迅速，这可能导致术前模板假体与患者实际截骨区域之间无法完全匹配，且无法在手术操作过程中根据实际情况进行调整。此外，许多手术导板仅能实现原生髋臼的精确定位，却无法保证恢复原始髋臼的前倾外展角。基于上述背景，本发明设计发明一种易于操作的可塑性通用型手术导板，使得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外展角和前倾角。
发明内容
为了克服现有半骨盆切除术后髋关节重建技术制备成本高，不确定性大，无法根据术中实际情况实时调整等不足，本发明提供了一种可塑性通用型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，且操作简单，制备成本低，可重复使用，可根据患者术中实际情况进行调整匹配。
本发明解决其技术问题所采用的技术方案是：
一种可塑性通用型髋臼精准定位手术导板，包括头部、体部和尾部。
所述头部包括第一引导单元和第二引导单元，所述第一引导单元为一与组配式髋臼假体髋臼杯组件大小匹配的半球形结构，第二引导单元为一直径略大于第一引导单元模块的圆形板状结构，用于确定原生髋臼的前倾外展角。
所述体部包括第一连接单元和第二连接单元，所述第一连接单元为一两端较宽中间较细的弧形可调节金属片，所述第一连接单元一端与头部第二引导单元相连，另一端与第二连接单元相连；所述弧形可调节金属片采用可塑性金属材料，可根据手术实际需要进行塑形调节。所述第二连接单元为一侧包括若干圆柱形插槽的金属板，可与导板尾部相连从而固定导板的头部和体部。
所述尾部为一独立的固定单元，所述固定单元包括一块侧面依次间隔排列有三个螺钉孔和三个圆柱形凸起的金属钢板。所述尾部通过在螺钉孔内打入锁定钉固定于髂嵴外侧下方平坦骨面上；所述圆柱形凸起可与导板体部第二连接单元的圆柱形插槽匹配，实现整个手术导板固定。
通过采用上述技术方案，本发明手术导板在充分暴露患者的髋臼后，将尾部利用锁定钉牢牢固定于髂骨嵴外下方平坦骨面处。通过尾部的三个圆柱形凸起和体部第二连接单元的三个圆柱形插槽相匹配，利用导板体部第一连接单元金属材料的可塑性，反复调节体部第一连接单元弯曲弧度及旋转角度，使导板头部恰好与患侧髋臼吻合，以此来精确定位髋臼位置及其外展前倾角，随后撤去头部和体部，并维持当前体部第一连接单元的形状，避免误触导致其二次形变。待肿瘤切除后再次连接已完成调节的头部和体部，安装组配式髋臼假体，选择高度及大小匹配的髋臼杯组件扣于头部第二引导单元，使杯缘与第一引导单元相抵，确定髋臼假体的位置和外展前倾角。假体安装固定后再次撤去导板头部和体部，撤去植入髂骨的锁定钉，移除导板尾部即可。
本发明的有益效果是：
(1)相较于传统凭借外科医生经验进行髋臼假体定位极大地减少了重建的不确定性，精确定位髋臼的同时保留原有的前倾外展角，使髋关节旋转中心及角度均处于最佳位置，减少术后并发症发生，有利于患者术后功能恢复。
(2)手术导板采用可塑性金属材料制作体部第一连接单元，可根据术中实际情况实时调整，无需提前设计、制备，减少术前准备时间，方便应对侵袭性较强的恶性肿瘤术中情况与术前数字影像学资料不相符的意外情况。
(3)使用通用型组件，操作简单，且可重复利用，减少医疗成本。
附图说明：
图1：手术导板三视图，(a)主视图，(b)左视图,(c)俯视图。
图2：手术导板头体部组件三视图，(a)主视图，(b)左视图，(c)俯视图。
图3：手术导板尾部三视图，(a)主视图，(b)左视图，(c)俯视图。
图4：锁定钉结构示意图。
图5：手术导板尾部应用示意图。
图6：手术导板应用示例。
其中，头部1，第一引导单元2，第二引导单元3，体部4，第一连接单元5，第二连接单元6，尾部7，圆柱形凸起8，螺钉孔9，锁定钉10。
具体实施方式
实施例1：
一种可塑性通用型髋臼精准定位手术导板，包括头部1、体部4和尾部7。
所述头部1包括第一引导单元2和第二引导单元3，所述第二引导单元3为一与组配式髋臼假体髋臼杯组件大小匹配的半球形结构，第一引导单元2为一直径略大于第一引导单元模块的圆形板状结构，用于确定原生髋臼的前倾外展角。
所述体部包括第一连接单元5和第二连接单元6，所述第一连接单元5为一两端较宽中间较细的弧形可调节金属片，所述第一连接单元5一端与头部第二引导单元3相连，另一端与第二连接单元6相连；所述弧形可调节金属片采用可塑性金属材料，可根据手术实际需要进行塑形调节(如可采用厚度较薄的铝片或铁片以方便调节第一连接单元5的弯曲弧度及旋转角度，从而使导板的头部1恰好与患侧髋臼吻合，以此来精确定位髋臼位置及其外展前倾角)。所述第二连接单元6为一侧包括三个圆柱形插槽的金属板，可与导板的尾部7相连从而固定导板的头部1和体部4。
所述尾部7为一独立的固定单元，所述固定单元包括一块侧面依次间隔排列有三个螺钉孔9和三个圆柱形凸起8的长方体形锁定金属钢板。所述尾部7通过在螺钉孔9内打入锁定钉10固定于髂嵴外侧下方平坦骨面上；所述圆柱形凸起8可与体部4的第二连接单元6的圆柱形插槽匹配，实现整个手术导板固定。
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，充分暴露患侧骨盆，打开髋臼并切断韧带，使股骨头脱位，暴露髋臼及其周围结构。将通用型手术导板尾部7贴合于髂骨边缘外侧骨面，用电钻建立孔道，植入3枚锁定钉10将尾部7临时固定于骨盆之上。通过尾部7中的三个圆柱形凸起8和第二连接单元6中的三个圆柱形插槽相匹配，连接符合实际情况的头部1和体部4，反复调节体部第一连接单元5弯曲弧度及旋转角度，使导板的头部1恰好与患侧髋臼及其边缘吻合，以此来精确定位髋臼位置及其外展前倾角，随后撤去头部1和体部4，并保持导板体部第一连接单元5当前的形变状态。
随后根据肿瘤的范围在髂骨、耻骨和/或坐骨进行截骨术，手术切缘严格符合肌肉骨骼肿瘤学会系统的规范。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1的第二引导单元3准确吻合，并抵于第一引导单元2之上。确定组配式髋臼假体最终位置后即可撤出导板头部1和体部4，用电钻撤出锁定钉后移除导板的尾部7。最后常规放置股骨头假体，完成髋关节复位重建过程。
术后常规放置引流管，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周开始逐渐增加负重，进行髋关节功能锻炼。
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 (3)
1.一种可塑性通用型髋臼精准定位手术导板，其特征在于，包括头部、体部和尾部；
所述头部包括第一引导单元和第二引导单元，所述第一引导单元为与组配式髋臼假体髋臼杯组件大小匹配的半球形结构，第二引导单元为一直径大于第一引导单元的圆形板状结构，用于确定原生髋臼的前倾外展角；
所述体部包括第一连接单元和第二连接单元；所述第一连接单元为一两端较宽中间较细的弧形可调节金属片，所述第一连接单元一端与头部第二引导单元相连，另一端与第二连接单元相连；所述第一连接单元可根据实际需要进行塑形调节；所述第二连接单元为一侧包括若干圆柱形插槽的金属板，所述第二连接单元的另一端与导板的尾部相连，从而固定导板的头部和体部；
所述尾部为一独立的固定单元，所述固定单元为一块金属钢板，所述的金属钢板上间隔排列有若干螺钉孔和若干圆柱形凸起；所述尾部通过在螺钉孔内打入锁定钉固定于髂嵴外侧下方平坦骨面上；所述圆柱形凸起与导板体部第二连接单元上的圆柱形插槽匹配，实现整个手术导板固定。
2.根据权利要求1所述的可塑性通用型髋臼精准定位手术导板，其特征在于，所述的弧形可调节金属片采用可塑性金属材料。
3.根据权利要求1或2所述的可塑性通用型髋臼精准定位手术导板的使用方法，其特征在于，步骤如下：在充分暴露患者的髋臼后，将尾部利用锁定钉固定于髂骨嵴外下方平坦骨面处；将尾部的圆柱形凸起插入体部第二连接单元的圆柱形插槽内，调节体部第一连接单元的弯曲弧度及旋转角度，使导板头部恰好与患侧髋臼吻合，以此来精确定位髋臼位置及其外展前倾角，随后撤去头部和体部，并维持当前体部第一连接单元的形状；待肿瘤切除后再次连接已完成调节的头部和体部，安装组配式髋臼假体，选择高度及大小匹配的髋臼杯组件扣于头部第二引导单元，使杯缘与第一引导单元相抵，确定髋臼假体的位置和外展前倾角；假体安装固定后再次撤去导板头部和体部，撤去植入髂骨的锁定钉，移除导板尾部即可。
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