CN112754736A - 个性化半骨盆假体及其制作方法 - Google Patents

个性化半骨盆假体及其制作方法 Download PDF

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CN112754736A
CN112754736A CN202110033223.8A CN202110033223A CN112754736A CN 112754736 A CN112754736 A CN 112754736A CN 202110033223 A CN202110033223 A CN 202110033223A CN 112754736 A CN112754736 A CN 112754736A
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sacrum
stress
personalized
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joint
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刘傥
杨晶
莫富灏
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Second Xiangya Hospital of Central South University
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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

本发明公开了一种个性化半骨盆假体及其制作方法，个性化半骨盆假体包括骶骨基座、连接件和股骨端关节柄；骶骨基座包括骶骨托和应力传导管；骶骨托为L型，其转角中心位置处设有通孔；应力传导管为圆弧管，其高端固接于通孔内；连接件包括连接臂和关节球头，连接臂与圆弧管相匹配的圆弧臂，关节球头设置于连接臂的低端，连接臂同轴置于应力传导管内；股骨端关节包括托举杯，关节球头球铰与托举杯内。应力传导通道通过有限元分析得出符合原骨盆固有的生物力学性能，能提高连接的稳定性和可靠性。通过关节球头和托举杯的设置，形成反球形托举关节，能更好地承担上班上重量，利于负重，自由度更大，利于术后早期活动，患者生活质量得到明显改善。

Description

个性化半骨盆假体及其制作方法
技术领域
本发明属于高值医用耗材技术领域，特别是涉及一种个性化半骨盆假体及其制作方法。
背景技术
骨盆的结构、生物力学复杂，在肿瘤骨盆切除及外伤致骨盆毁损重建过程是目前临床研究的重点和难点。尤其是骨盆Ⅰ—Ⅳ切除后的半骨盆重建，如何设计并制造符合骨盆生物力学传导通道的假体最大限度避免术后假体松动、固定装置断裂等并发症发生及保持假体长期稳定是目前的难点。
现有个性化半骨盆假体将骶骨固定在骶骨座侧翼上，再将髋臼杯固定于骶骨座下方，并不是直接固定于骶骨，固定方式不符合原骨盆固有的生物力学通道，假体与骶骨接触面未能形成永久链接、这就使假体螺钉松动，螺钉断裂等并发症发生率增高，再者患者不能早期下床活动，骨盆肿瘤半骨盆切除术中面临软组织巨大缺损，面临着修补关节周围软组织的困难，旋转中心不好掌握，脱位发生率高，术后早期患者不能很好的负重，长期卧床不利于术后快速康复。
发明内容
本发明的目的在于针对现有技术的不足之处，提供一种负重好、自由度大的骨盆假体及其制作方法。
本发明提供的这种个性化半骨盆假体，它包括骶骨基座、连接件和股骨端关节柄；骶骨基座包括骶骨托和应力传导管；骶骨托为L型，其转角中心位置处设有通孔；应力传导管为圆弧管，其高端固接于通孔内；连接件包括连接臂和关节球头，连接臂与圆弧管相匹配的圆弧臂，关节球头设置于连接臂的低端，连接臂同轴置于应力传导管内；股骨端关节包括托举杯，关节球头球铰与托举杯内。
所述骶骨基座采用钛合金3D打印一体成型，所述应力传导管的半径及弧度基于盆骨CT数据，通过有限元动态分析得出。
所述骶骨托上设有多个万向锁定螺钉孔。
这种个性化半骨盆假体还包括骶骨接触层，骶骨接触层与所述骶骨基座的形状相匹配，连接于骶骨基座的内壁。
所述骶骨接触层为钽合金多孔解除层。
所述托举杯为球形，其容积超半圆，其开口向上，托举所述关节球头。
所述股骨端关节还包括托举柄，托举柄与所述托举杯一体成型，托举柄位于托举杯下用以插入股骨近端。
本发明还提供了一种个性化半骨盆假体的制作方法，包括如下步骤：
步骤一、根据骨盆影像数据重建三维图像；
步骤二、将三维图像导入Geomagic Studio软件进行前处理；
步骤三、根据处理后的三维图像，在三维软件建立三维模型，并将三维模型导入有限元软件进行受力分析，并导出应力云图，模拟出骨盆的应力传导通道；
步骤四、根据应力传导通道通过钛合金3D打印骶骨基座；
步骤五、根据骶骨基座制作相应的连接臂。
在所述步骤一中利用Mimics软件重建三维图像，以STL格式对三维图像进行存储并输出，随即导入到Geomagic Studio软件将三维成像数据前处理，以使得有限元分析更加准确，将处理后数据导入Solid Works软件进行建模装配。
在所述步骤三中：将三维模型各接触面的接触条件设置成为“面—面接触”，将股骨头和髋臼设为绑定连接，在骶骨上逐渐给予100-500N的应力，模拟站立位骨盆受力情况，行有限元分析，最终得出患者骨盆的负重的应力云图，并模拟出骨盆的应力传导通道。
本发明一方面通过有限元分析得出骨盆的负重应力云图，并模拟出骨盆的应力传导通道，再根据此通道3D打印出带有应力传导管的骶骨基座。该应力传导管符合原骨盆固有的力学性能，能提高连接的稳定性和可靠性。另一方面，通过关节球头和托举杯的设置，托举杯开槽向上，关节球头置于托举杯内，股骨端为托举式，形成反球形关节，能更好地承担上班上重量，早期负重，尤其适合体重过大患者，自由度更大，且有利于负重，术后早期活动，快速康复，远期假体不易松动、移位，患者生活质量得到明显改善。
附图说明
图1为本发明一个优选实施例的装配示意图。
图2为图1的爆炸示意图。
图示序号：
1—骶骨基座，11—骶骨托，12—应力传导管；
2—连接件，21—连接臂，22—关节球头；
3—股骨端关节柄，31—托举柄，32—托举杯；
4—骶骨接触层。
具体实施方式
如图1、图2所示，本实施例公开的这种个性化半骨盆假体它由骶骨基座1、连接件2和股骨端关节柄3三部分构成，骶骨基座1与股骨端关节柄3通过连接件2相连，各部成模块化设计，便于术中安装。
为了符合生物力学通道，将骶骨基座1采用如下方法设计。
在实际运用过程中，由于患者拟切除病变侧骨盆经肿瘤破坏，故利用数据导入逆向工程软件，将患者健侧骨盆镜像成型，然后将完整骨盆影像学数据导入Mimics软件，重建出三维图像，最终以STL格式对三维图像进行存储并输出，随即导入到Geomagic Studio软件将三维成像数据前处理，以使得有限元分析更加准确，将处理后数据导入Solid Works软件进行装配，装配成型后导入有限元分析软件(Anasys)，在软件中将骶髂关节面接触条件设置成为“面和面接触”，将股骨头和髋臼设为绑定连接，在骶1骶骨上逐渐给予100-500N的应力，模拟站立位骨盆受力情况，行有限元分析，最终得出患者骨盆的负重的应力云图，并模拟出骨盆的应力传导通道，按此通道设计并利用钛合金3D打印一体化成型的骶骨基座1将残存骶骨精确包绕。
骶骨基座1包括骶骨托11和应力传导管12。骶骨托11为L型，其侧壁上设置多个万向锁定螺钉孔，螺钉可依据残留骶骨选择方向，给予适宜方向的锁定螺钉给予侧方辅助绞锁固定，骶骨托的转角为圆弧转角，并在转角中心位置处设有通孔以设置应力传导管12。应力传导管12为圆弧管，其高端固接于通孔内，应力传导管12应力传导管的半径及弧度基于个体盆骨CT数据，基于研究所建立的有限元分析数据库定义。骶骨基座1制作完成后，利用钽合金3D打印出与骶骨托内表面相匹配的骶骨接触层4，骶骨接触层4为多孔面，钽金属多孔状结构有利于骨长入。并根据应力传导管12的形状制作连接件2。
连接件2包括连接臂21和关节球头22，连接臂与圆弧管相匹配的圆弧臂，关节球头设置于连接臂的低端。连接件以连接臂同轴置于应力传导管内、插入骶骨，完成骶骨、骶骨托及关节球头的一体化固定，并以关节球头与股骨端关节柄3装配。
股骨端关节柄3包括托举柄31和托举杯32。托举柄31与托举杯32一体成型，托举柄位于托举杯下用以插入股骨近端。托举杯32为球形，其容积超半圆，其开口向上。装配时，将关节球头22置入托举杯32内，形成反球托举式关节，使股骨端为托举式，能更好地承担上班上重量，早期负重，尤其适合体重过大患者，自由度更大，且有利于负重，术后早期活动，快速康复，远期假体不易松动、移位，患者生活质量得到明显改善。
本发明一方面通过有限元分析得出骨盆的负重应力云图，并模拟出骨盆的应力传导通道，再根据此通道3D打印出带有应力传导管的骶骨基座。该应力传导管符合原骨盆固有的生物力学通道，能提高连接的稳定性和可靠性。另一方面，通过关节球头和托举杯的设置，托举杯开槽向上，关节球头置于托举杯内，股骨端为托举式，形成反球形关节，能更好地承担上班上重量，早期负重，尤其适合体重过大患者，自由度更大，且有利于负重，术后早期活动，快速康复，远期假体不易松动、移位，患者生活质量得到明显改善。
相较于现有产品而言，其具有以下优点：
1、采用有限元分析获得力学性能更好的骶骨基座，保证投入使用后各部稳定可靠，避免术后假体松动、固定装置断裂等并发症发生，保持假体长期稳定。
2、反球托举式关节链接装置更好的承重，有利于控制股骨旋转中心，使患者早期活动，避免长期卧床，促进患者快速康复。
3、3D打印钽金属骶骨基座更好地与残存骶骨匹配，钽金属多孔状结构有利于骨长入。
4、底座侧方万向锁定螺钉孔可将螺钉任意方向将骶骨座与残存骶骨固定。有限元生物力学分析并3D打印一体化成型的力学螺钉孔，可将上半身重力直接传到至下肢，更符合人体生物力学。
5、组配式假体，3D打印模块缩短成型时间，组配式模块便于术中安装。

Claims (10)

1.一种个性化半骨盆假体，其特征在于：它包括骶骨基座、连接件和股骨端关节柄；
骶骨基座包括骶骨托和应力传导管；骶骨托为L型，其转角中心位置处设有通孔；应力传导管为圆弧管，其高端固接于通孔内；
连接件包括连接臂和关节球头，连接臂与圆弧管相匹配的圆弧臂，关节球头设置于连接臂的低端，连接臂同轴置于应力传导管内；
股骨端关节包括托举杯，关节球头球铰与托举杯内。
2.如权利要求1所述的个性化半骨盆假体，其特征在于：所述骶骨基座采用钛合金3D打印一体成型，所述应力传导管的半径及弧度基于盆骨CT数据，通过有限元动态分析得出。
3.如权利要求1所述的个性化半骨盆假体，其特征在于：所述骶骨托上设有多个万向锁定螺钉孔。
4.如权利要求1所述的个性化半骨盆假体，其特征在于：它还包括骶骨接触层，骶骨接触层与所述骶骨基座的形状相匹配，连接于骶骨基座的内壁。
5.如权利要求4所述的个性化半骨盆假体，其特征在于：所述骶骨接触层为钽合金多孔解除层。
6.如权利要求1所述的个性化半骨盆假体，其特征在于：所述托举杯为球形，其容积超半圆，其开口向上，托举所述关节球头。
7.如权利要求6所述的个性化半骨盆假体，其特征在于：所述股骨端关节还包括托举柄，托举柄与所述托举杯一体成型，托举柄位于托举杯下用以插入股骨近端。
8.一种个性化半骨盆假体的制作方法，其特征在于，本方法包括如下步骤：
步骤一、根据骨盆影像数据重建三维图像；
步骤二、将三维图像导入Geomagic Studio软件进行前处理；
步骤三、根据处理后的三维图像，在三维软件建立三维模型，并将三维模型导入有限元软件进行受力分析，并导出应力云图，模拟出骨盆的应力传导通道；
步骤四、根据应力传导通道通过钛合金3D打印骶骨基座；
步骤五、根据骶骨基座制作相应的连接臂。
9.如权利要求8所述的个性化半骨盆假体的制作方法，其特征在于：在所述步骤一中利用Mimics软件重建三维图像，以STL格式对三维图像进行存储并输出，随即导入到GeomagicStudio软件将三维成像数据前处理，以使得有限元分析更加准确，将处理后数据导入SolidWorks软件进行建模装配。
10.如权利要求8所述的个性化半骨盆假体的制作方法，其特征在于，在所述步骤三中：将三维模型各接触面的接触条件设置成为“面—面接触”，将股骨头和髋臼设为绑定连接，在骶骨上逐渐给予100-500N的应力，模拟站立位骨盆受力情况，行有限元分析，最终得出患者骨盆的负重的应力云图，并模拟出骨盆的应力传导通道。
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Cited By (1)

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Publication number Priority date Publication date Assignee Title
CN116747053A (zh) * 2023-08-11 2023-09-15 北京爱康宜诚医疗器材有限公司 骶骨假体

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116747053A (zh) * 2023-08-11 2023-09-15 北京爱康宜诚医疗器材有限公司 骶骨假体
CN116747053B (zh) * 2023-08-11 2023-12-19 北京爱康宜诚医疗器材有限公司 骶骨假体

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