WO2018006430A1 - 髋骨修复体 - Google Patents

髋骨修复体 Download PDF

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Publication number
WO2018006430A1
WO2018006430A1 PCT/CN2016/089488 CN2016089488W WO2018006430A1 WO 2018006430 A1 WO2018006430 A1 WO 2018006430A1 CN 2016089488 W CN2016089488 W CN 2016089488W WO 2018006430 A1 WO2018006430 A1 WO 2018006430A1
Authority
WO
WIPO (PCT)
Prior art keywords
rod
axial tooth
tooth portion
hip bone
screw
Prior art date
Application number
PCT/CN2016/089488
Other languages
English (en)
French (fr)
Inventor
郭卫
王彩梅
姬涛
Original Assignee
北京爱康宜诚医疗器材有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京爱康宜诚医疗器材有限公司 filed Critical 北京爱康宜诚医疗器材有限公司
Priority to EP16907934.0A priority Critical patent/EP3482721B1/en
Priority to PCT/CN2016/089488 priority patent/WO2018006430A1/zh
Priority to US16/316,104 priority patent/US10806589B2/en
Publication of WO2018006430A1 publication Critical patent/WO2018006430A1/zh

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Abstract

一种髋骨修复体，包括：修复主体(10)，修复主体(10)呈拱形结构，修复主体(10)包括第一端部(11)以及第二端部，第一端部(11)与骶骨(1)接触配合；髋臼杯(20)和连接装置(30)，髋臼杯(20)通过连接装置(30)位置可调整地与第二端部连接。该技术方案能够有效地解决现有技术中的钉棒系统支撑不可靠，容易疲劳断裂的问题。

Description

髋骨修复体 技术领域
本发明涉及医疗器械领域，具体而言，涉及一种髋骨修复体。
背景技术
骨盆是骨肿瘤好发的部位，骨盆肿瘤可分为原发肿瘤和转移肿瘤。前者主要为软骨肉瘤、骨肉瘤和尤文肉瘤，后者常见于乳房癌、肾癌、前列腺癌、肺癌等的骨转移。骨盆肿瘤发病隐匿且早期诊断困难，往往发现时侵犯范围已经很大，加上骨盆周围解剖复杂并与很多重要脏器毗邻，手术难度大，并发症多，疗效欠佳，死亡率高。目前，对骨盆肿瘤主要采取半骨盆切除或改良半骨盆切除截肢术。但任何骨盆肿瘤的切除均会造成骨缺损，骨缺损会导致患者躯干和下肢连续性中断，影响站立和负重行走，患者将不能承担体重。并且行走的时候会产生疼痛，且患者长时间负重行走后，髋臼会出现内倾、上移。骨盆倾斜后会导致脊柱侧弯，导致患者术后生活质量严重下降。
二十世纪70年代以前，发生于骨盆区的恶性骨肿瘤大多数需要行骨盆切除术，传统的骨盆切除术是将病变骨盆与同侧下肢一并切除，因而造成了病人的严重残疾。随着化疗和放疗等辅助治疗方法的发展、先进影像手段的出现以及各类手术技术的提高，一些原来只能靠截肢才能治疗的肿瘤现在也可以施行保肢手术，大大减少了病人的残疾。目前，对80％以上的骨盆恶性肿瘤患者均行保肢治疗。
由于骨盆区解剖结构复杂，骨盆恶性骨肿瘤的保肢手术极具挑战性。骨盆环是由骶骨和两侧的髋骨组成，每侧髋骨由髂骨、坐骨和耻骨构成。骨盆肿瘤的广泛切除通常会造成较大的骨缺损，使骨盆的连续性中断，并损失周围的部分软组织。肌肉骨骼系统肿瘤协会提出了骨盆肿瘤切除术的分型，按解剖学部位(髂骨为I区，髋臼区为II区，闭孔区为III区)将手术类型分为：I型(髂骨切除)；II型(髋臼切除)；III型(闭孔区切除)；IV型(涉及骶骨的切除)。若同时切除两个或以上区域，则切除类型为相应区域的组合，如同时切除髂骨和髋臼区，则手术类型为I、II型；切除整个骨盆为I、II、III型；若同时切除股骨头，则为H型(如II H；I、II H，II、III H)。
骨盆肿瘤切除术后骨盆环的重建十分必要，这样可以将躯干的重量传导至下肢。对缺损的骨盆进行重建根据术者经验、患者情况不同手段各异，常用的重建方法有旷置术、髋关节移位术、骨融合术、结构性异体自体骨移植、人工假体及人工假体复合异体骨移植。
传统方法并无法重建整个半侧骨盆的缺损(髂骨、髋臼及耻坐骨)，本发明拟解决半侧骨盆切除后缺损重建问题。
发明内容
本发明旨在提供一种髋骨修复体，以解决现有技术中的钉棒系统支撑不可靠，容易疲劳断裂的问题。
为了实现上述目的，本发明提供了一种髋骨修复体，包括：修复主体，修复主体呈拱形结构，修复主体包括第一端部以及第二端部，第一端部与骶骨接触配合；髋臼杯和连接装置，髋臼杯通过连接装置位置可调整地与第二端部连接。
进一步地，连接装置包括第一连接部和第二连接部，第一连接部的中心线和第二连接部的中心线成角度设置，第二端部具有与第一连接部连接的第三连接部，髋臼杯具有与第二连接部连接的第四连接部。
进一步地，第一连接部为第一轴向齿部，第二连接部为第二轴向齿部，第三连接部为第三轴向齿部，第四连接部为第四轴向齿部，第一轴向齿部与第三轴向齿部相配合，以使修复主体与连接装置之间的角度可调节，第二轴向齿部与第四轴向齿部相配合，以使髋臼杯与连接装置之间的角度可调节。
进一步地，第一轴向齿部与第三轴向齿部通过第一紧固件连接在一起，第二轴向齿部与第四轴向齿部通过第二紧固件连接在一起。
进一步地，髋臼杯的内壁上具有环槽。
进一步地，髋臼杯的杯壁上具有通孔。
进一步地，髋骨修复体还包括钉棒结构，钉棒结构包括连接座以及棒体，连接座与修复主体连接，棒体固定在连接座上，第一端部上设置有螺钉孔，螺钉孔内设置有钉座，钉座具有球形内表面。
进一步地，连接座包括：连接螺钉，连接螺钉的一端与修复主体连接，连接螺钉的另一端具有球形钉头；棒体固定部，用以固定棒体，棒体固定部的一端具有与球形钉头相配合的球形内壁，以使棒体固定部可旋转地设置在连接螺钉上。
进一步地，棒体固定部包括U形支座及固定帽，棒体夹设在U形支座与固定帽之间。
进一步地，修复主体上设置有防脱机构，防脱机构夹设在修复主体与连接座之间，防脱机构包括与容纳在螺钉孔内的螺钉配合的第一防脱触角。
进一步地，防脱机构还包括防脱主体，防脱主体夹设在修复主体与连接座之间，防脱机构还包括第二防脱触角，第一防脱触角以及第二防脱触角均与防脱主体连接并向外延伸，第二防脱触角上设置有与棒体配合的限位套。
应用本发明的技术方案，髋骨修复体包括修复主体、髋臼杯和连接装置。修复主体的第一端部与骶骨接触配合，髋臼杯与髋臼接触配合。上述修复主体呈拱形结构，具有良好的力学性能，改善了结构的内力分布。在承受较高的应力和剪切力的情况下，能够维持髋骨修复体的刚度，使得骨质不容易受到破坏。因此上述结构解决了现有技术中的钉棒系统支撑不可靠，容易疲劳断裂，所导致的骨质易受损坏的问题。此外，应用本发明的技术方案，髋臼杯 通过连接装置位置可调整地与修复主体的第二端部连接，上述结构使得医生可以根据患者自身的实际情况来调整修髋臼杯的位置，保证髋臼杯处于良好的安装角度。
附图说明
构成本申请的一部分的说明书附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1示出了根据本发明的髋骨修复体的实施例的与骶骨配合的立体结构示意图；
图2示出了图1的髋骨修复体的立体结构示意图；
图3示出了图1的髋骨修复体的连接座的立体结构示意图；
图4示出了图3的连接座的纵剖结构示意图；
图5示出了图1的髋骨修复体的另一个连接座的立体结构示意图；
图6示出了图5的连接座的纵剖结构示意图；以及
图7示出了图1的髋骨修复体的防脱机构的立体结构示意图。
其中，上述附图包括以下附图标记：
1、骶骨；10、修复主体；11、第一端部；111、螺钉孔；20、髋臼杯；21、环槽；22、通孔；30、连接装置；41、第一轴向齿部；42、第三轴向齿部；51、第二轴向齿部；52、第四轴向齿部；61、连接座；611、连接螺钉；6111、球形钉头；612、棒体固定部；6121、U形支座；6122、固定帽；62、连接座；621、连接螺钉；6211、球形钉头；622、棒体固定部；6221、U形支座；6222、固定帽；63、棒体；70、防脱机构；71、第一防脱触角；72、防脱主体；73、第二防脱触角；74、限位套。
具体实施方式
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本发明。
如图1和图2所示，本实施例的髋骨修复体包括修复主体10、髋臼杯20和连接装置30。其中，修复主体10呈拱形结构，修复主体10包括第一端部11以及第二端部，第一端部11与骶骨1接触配合；髋臼杯20通过连接装置30位置可调整地与第二端部连接。
应用本实施例的技术方案，髋骨修复体包括修复主体10、髋臼杯20和连接装置30。修复主体10的第一端部11与骶骨1接触配合，髋臼杯20与髋臼接触配合。上述修复主体10呈拱形结构，具有良好的力学性能，改善了结构的内力分布。在承受较高的应力和剪切力的情况下，能够维持髋骨修复体的刚度，使得骨质不容易受到破坏。因此上述结构解决了现有技术中的钉棒系统支撑不可靠，容易疲劳断裂，所导致的骨质易受损坏的问题。此外，应用 本发明的技术方案，髋臼杯20通过连接装置30位置可调整地与修复主体10的第二端部连接，上述结构使得医生可以根据患者自身的实际情况来调整修髋臼杯的位置，从而保证了髋臼杯20能够处于良好的安装角度，进而使得患者的术后恢复更好。
如图1和图2所示，在本实施例中，连接装置30包括第一连接部和第二连接部，第一连接部的中心线和第二连接部的中心线成角度设置，第二端部具有与第一连接部连接的第三连接部，髋臼杯20具有与第二连接部连接的第四连接部。具体地，当医生在调整髋臼杯20的位置时，既可以髋臼杯20既可以绕着第一连接部的中心线转动，也可以绕着第二连接部的中心线转动。这样，使得医生调整修髋臼杯的位置更加精准，更加符合患者的实际情况，从而进一步使得患者的术后恢复更好。
如图2所示，在本实施例中，第一连接部为第一轴向齿部41，第二连接部为第二轴向齿部51，第三连接部为第三轴向齿部42，第四连接部为第四轴向齿部52，第一轴向齿部41与第三轴向齿部42相配合，以使修复主体10与连接装置之间的角度可调节，第二轴向齿部51与第四轴向齿部52相配合，以使髋臼杯20与连接装置30之间的角度可调节。具体地，当医生在调整修髋臼杯的位置时，需要将第一轴向齿部41与第三轴向齿部42相扣合，即第一轴向齿部41插入第三轴向齿部42上的槽中。同样的，需要将第二轴向齿部51与第四轴向齿部52相扣合，即第二轴向齿部51插入第四轴向齿部52上的槽中。上述结构简单、易于装配，一定程度上缩短了手术时间，降低感染机会。
当然，本领域技术人员应当知晓第一连接部、第二连接部、第三连接部、第四连接部可以不为轴向齿轮结构。可以在第一连接部与第三连接部之间另增加角度调节结构，该角度调节结构可以设置在第一连接部和/或第三连接部上。同样，也可以在第二连接部与第四连接部之间另增加角度调节结构，该角度调节结构可以设置在第二连接部和/或第四连接部上。
在本实施例中，第一轴向齿部41与第三轴向齿部42通过第一紧固件(图中未示出)连接在一起，第二轴向齿部51与第四轴向齿部52通过第二紧固件(图中未示出)连接在一起。优选地，在本实施例中，第一紧固件与第二紧固件为螺钉。上述结构简单、易于装配。
在本实施例中，髋臼杯20的内壁将与半球状聚乙烯内衬通过骨水泥粘接。为了便于骨水泥的嵌入，如图2所示，在本实施例中，髋臼杯20的内壁上具有环槽21。上述结构简单、易于实现。
如图2所示，为了使髋臼杯20与半球状聚乙烯内衬更好的连接，在本实施例中，髋臼杯20的杯壁上具有通孔22。上述结构使得骨水泥进入通孔22形成锚定。优选地，通孔22为5～10个。
如图1和图2所示，在本实施例中，髋骨修复体还包括钉棒结构，钉棒结构包括连接座61、连接座62以及棒体63，连接座61与腰椎椎体连接，连接座62与修复主体10连接，棒体63固定在连接座61和连接座62上。上述结构加强了修复主体10与腰椎椎体之间的固定，增加了骶骨1的稳定性，从而避免了腰椎部位下沉。
如图3和图4所示，在本实施例中，连接座61包括：连接螺钉611，连接螺钉611的一端与腰椎椎体连接，连接螺钉611的另一端具有球形钉头6111；棒体固定部612，用以固定棒体63，棒体固定部612的一端具有与球形钉头6111相配合的球形孔，以使棒体固定部612可旋转地设置在连接螺钉611上；上述结构使得棒体固定部612可旋转地设置在连接螺钉611上。这样，使得医生可以根据实际需要调整棒体63的位置，从而使得安装位置更加准确，安装过程更加简单。
如图5和图6所示，在本实施例中，连接座62包括：连接螺钉621，连接螺钉621的一端与修复主体10连接，连接螺钉621的另一端具有球形钉头6211；棒体固定部622，用以固定棒体63，棒体固定部622的一端具有与球形钉头6211相配合的球形内壁，以使棒体固定部622可旋转地设置在连接螺钉621上。上述结构使得棒体固定部622可旋转地设置在连接螺钉621上。这样，使得医生可以根据实际需要调整棒体63的位置，从而使得安装位置更加准确，安装过程更加简单。
如图3和图4所示，在本实施例中，棒体固定部612包括U形支座6121及固定帽6122，棒体63夹设在U形支座6121与固定帽6122之间。具体地，U形支座6121的U型内壁形成安装空间，棒体63插入上述安装空间中。U形支座6121的U型内壁的上部具有内螺纹，固定帽6122具有与U形支座6121的内螺纹相适配的外螺纹。在安装棒体63时，需要先将棒体63从安装空间中穿出，再将固定帽6122螺接在U形支座6121上。上述结构简单、安装方便。
如图5和图6所示，在本实施例中，棒体固定部622包括U形支座6221及固定帽6222，棒体63夹设在U形支座6221与固定帽6222之间。具体地，U形支座6221的U型内壁形成安装空间，棒体63插入上述安装空间中。U形支座6221的U型内壁的上部具有内螺纹，固定帽6222具有与U形支座6221的内螺纹相适配的外螺纹。在安装棒体63时，需要先将棒体63从安装空间中穿出，再将固定帽6222螺接在U形支座6221上。上述结构简单、安装方便。
如图1和图2所示，在本实施例中，第一端部11上设置有螺钉孔111，螺钉孔111内设置有钉座，钉座具有球形内表面。当医生需要将修复主体10通过螺钉固定在骶骨1上时，首先将螺钉穿入螺钉孔111，由于螺钉孔111为锥孔，螺钉的头部为球头，钉座具有与球头配合的球形内表面，因此螺钉能够在一定范围内转动，医生可以根据实际情况选择螺钉的钉入方向。上述结构使得医生能够根据实际情况选取螺钉固定位置，使得修复主体10与骶骨1之间的固定效果更佳。
优选地，在本实施例中，修复主体10为中空桁架结构，一方面，上述桁架结构能够极大地减小修复主体10的质量，提高材料利用率，同时还能够保证修复主体10的强度以及刚度。另一方面，使用上述结构能够使得修复主体10更加靠近相邻的骨骼，从而使得骨性融合的效果更佳。由于骨盆肿瘤切除后解剖重建不仅需要满足精准、复杂的要求，甚至于还需要满足一次性、量身定做的要求。因此，在本实施例中，修复主体10通过3D打印成型。上述工艺本身具有精准、能够制造复杂零件且能够个性定制的特点。
需要说明的是，3D打印快速成型技术是基于材料堆积法的一种全新制造技术，区别于传统的去除材料加工技术，又称为增材制造(AKYCM，AKYCdditive MAKYCnufAKYCcturing)。3D打印技术是利用三维CAKYCD的数据，通过快速成型机，将一层层的材料堆积成实体。不同种类的快速成型系统因所用成型材料不同，成型原理和系统特点也各有差异，但是基本原理一样，那就是“分层制造，逐层叠加”，犹如一台“立体打印机”，因此得名。随着制造技术、数字建模技术、数控技术、信息技术、材料科学与化学、生物技术等前沿技术的迅猛发展以及多学科的密切合作，3D打印技术的开发已经成为当今最热门的新技术之一。3D打印未来将在骨科领域呈现广阔的应用前景，其根本原因恰在于3D打印的特点满足了骨科的特殊要求。其一、骨组织是复杂结构的典型代表，现有的仿生技术很难复制其特有的三维形态和生理功能。而3D打印正适合复杂结构的快速制造，可获得近似理想的骨修复材料；其二、由于人体存在高度的个体特异性，传统大规模、批量化生产的医疗产品无法满足个性化的需要，而以往通过模具等生产制造工艺生产出的个性化、定制产品的成本高，周期长。随着数字化影像技术在医疗领域的广泛应用，骨骼是最容易获得精确数字化影像的器官，将其与3D打印相结合，可以精确、快速、低成本地生产个性化的医疗产品；因此，借助3D打印技术，短时间即可“铸造”出任意外形、理想的生物力学强度的内植物产品，使个体化、定制化骨植入产品的开发成为现实。
在本实施例中，第一端部11设置生物涂层(图中未示出)。上述结构能够很快地促成骨细胞生成，易于与骨质(骶骨)相整合，从而达到中远期的固定效果。与传统手术模式相比，具有高强度、高稳定性、骨整合能力强的优点。
在本实施例中，第一端部11设置有第一针状凸起(图中未示出)。上述第一针状凸起具有扦插锚定的作用，以使骶骨1与修复主体10的第一端部11固定在一起。
如图7所示，在本实施例中，修复主体上设置有防脱机构70，防脱机构70夹设在修复主体与连接座62之间，防脱机构70包括与容纳在螺钉孔111内的螺钉配合的第一防脱触角71。使用时，当连接座62旋紧时，第一防脱触角71顶住容纳在螺钉孔111内的螺钉，连接座62的连接螺钉621越紧，第一防脱触角71顶住螺钉的力就越大。因此上述结构能够防止螺钉从螺钉孔111内脱出。此外，在现有技术中，拧入骨头的连接螺钉621经常会发生松动。应用上述防脱机构70还能够为连接座62提供预紧力以防止连接座62松动。
如图7所示，在本实施例中，防脱机构70还包括防脱主体72，防脱主体72夹设在修复主体与连接座62之间，防脱机构70还包括第二防脱触角73，第一防脱触角71以及第二防脱触角73均与防脱主体72连接并向外延伸，第二防脱触角73上设置有与棒体63配合的限位套74。优选地，第一防脱触角71为与螺钉孔111配合的多个。由于多个第一防脱触角71向外延伸至螺钉孔111内，且防脱主体72夹设在修复主体与连接座62之间，因此防脱机构70被限位无法转动。又由于第二防脱触角73上设置有限位套74，限位套74与棒体63配合，因此棒体63也被限位无法转动。上述结构避免棒体63转动，从而增加了系统的稳定性。
优选地，防脱机构70为弹簧片，弹簧片的第二防脱触角73的尾端向上翘起，限位套74设置在第二防脱触角73的尾端。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (11)

  1. 一种髋骨修复体，其特征在于，包括：
    修复主体(10)，所述修复主体(10)呈拱形结构，所述修复主体(10)包括第一端部(11)以及第二端部，所述第一端部(11)与骶骨(1)接触配合；
    髋臼杯(20)和连接装置(30)，所述髋臼杯(20)通过所述连接装置(30)位置可调整地与所述第二端部连接。
  2. 根据权利要求1所述的髋骨修复体，其特征在于，所述连接装置(30)包括第一连接部和第二连接部，所述第一连接部的中心线和所述第二连接部的中心线成角度设置，所述第二端部具有与所述第一连接部连接的第三连接部，所述髋臼杯(20)具有与所述第二连接部连接的第四连接部。
  3. 根据权利要求2所述的髋骨修复体，其特征在于，所述第一连接部为第一轴向齿部(41)，所述第二连接部为第二轴向齿部(51)，所述第三连接部为第三轴向齿部(42)，所述第四连接部为第四轴向齿部(52)，所述第一轴向齿部(41)与所述第三轴向齿部(42)相配合，以使所述修复主体(10)与所述连接装置(30)之间的角度可调节，所述第二轴向齿部(51)与所述第四轴向齿部(52)相配合，以使所述髋臼杯(20)与所述连接装置(30)之间的角度可调节。
  4. 根据权利要求3所述的髋骨修复体，其特征在于，所述第一轴向齿部(41)与所述第三轴向齿部(42)通过第一紧固件连接在一起，所述第二轴向齿部(51)与所述第四轴向齿部(52)通过第二紧固件连接在一起。
  5. 根据权利要求1所述的髋骨修复体，其特征在于，所述髋臼杯(20)的内壁上具有环槽(21)。
  6. 根据权利要求1所述的髋骨修复体，其特征在于，所述髋臼杯(20)的杯壁上具有通孔(22)。
  7. 根据权利要求1所述的髋骨修复体，其特征在于，所述髋骨修复体还包括钉棒结构，所述钉棒结构包括连接座(62)以及棒体(63)，所述连接座(62)与所述修复主体(10)连接，所述棒体(63)固定在所述连接座(62)上，所述第一端部(11)上设置有螺钉孔(111)，所述螺钉孔(111)内设置有钉座，所述钉座具有球形内表面。
  8. 根据权利要求7所述的髋骨修复体，其特征在于，
    所述连接座(62)包括：
    连接螺钉(621)，所述连接螺钉(621)的一端与所述修复主体(10)连接，所述连接螺钉(621)的另一端具有球形钉头；
    棒体固定部(622)，用以固定所述棒体(63)，所述棒体固定部(622)的一端具有与所述球形钉头相配合的球形内壁，以使所述棒体固定部(622)可旋转地设置在所述连 接螺钉(621)上。
  9. 根据权利要求8所述的髋骨修复体，其特征在于，所述棒体固定部(622)包括U形支座(6221)及固定帽(6222)，所述棒体(63)夹设在所述U形支座(6221)与所述固定帽(6222)之间。
  10. 根据权利要求7的骶骨修复体，其特征在于，所述修复主体(10)上设置有防脱机构(70)，所述防脱机构(70)夹设在所述修复主体(10)与所述连接座(62)之间，所述防脱机构(70)包括与容纳在所述螺钉孔(111)内的螺钉配合的第一防脱触角(71)。
  11. 根据权利要求10的骶骨修复体，其特征在于，所述防脱机构(70)还包括防脱主体(72)，所述防脱主体(72)夹设在所述修复主体(10)与所述连接座(62)之间，所述防脱机构(70)还包括第二防脱触角(73)，所述第一防脱触角(71)以及所述第二防脱触角(73)均与所述防脱主体(72)连接并向外延伸，所述第二防脱触角(73)上设置有与所述棒体(63)配合的限位套(74)。
PCT/CN2016/089488 2016-07-08 2016-07-08 髋骨修复体 WO2018006430A1 (zh)

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