CN106175997B - 一种人工枢椎支撑体 - Google Patents

一种人工枢椎支撑体 Download PDF

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CN106175997B
CN106175997B CN201610520355.2A CN201610520355A CN106175997B CN 106175997 B CN106175997 B CN 106175997B CN 201610520355 A CN201610520355 A CN 201610520355A CN 106175997 B CN106175997 B CN 106175997B
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fixed ear
support body
atlas
lower fixed
guide plate
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CN106175997A (zh
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王建华
夏虹
尹庆水
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General Hospital of Guangzhou Military Command
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Priority to US16/088,827 priority patent/US10695188B2/en
Priority to PCT/CN2016/097561 priority patent/WO2018000572A1/zh
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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

本发明公开了一种人工枢椎支撑体，用于医疗器械技术领域，包括支撑本体，支撑本体包括冠部和体部，冠部的顶面形成顶部仿形面，体部的底面形成底部仿形面，所述支撑本体的内部形成空腔，空腔内设有微孔网格支架，空腔在支撑本体的表面形成多个窗口，体部的底端设有下固定耳，冠部的顶端设有上固定耳，上固定耳和下固定耳上均设有固定孔，支撑本体可通过螺钉与寰椎紧固连接，支撑本体可通过螺钉与第三颈椎紧固连接。支撑本体通过上下仿形面形成解剖贴合，同时通过上固定耳和下固定耳与寰椎和第三颈椎连接，其支撑和重建稳定性好，避免手术后假体的松动和失败，固定容易，形状匹配好，术后内固定失败率低，融合率高，能够满足复杂手术需要。

Description

一种人工枢椎支撑体
技术领域
本发明用于医疗器械技术领域，特别是涉及一种人工枢椎支撑体。
背景技术
累及上颈椎的结核、肿瘤等常常严重破坏寰枢椎的重要结构，并压迫脊髓，进而引起瘫痪的严重后果。这类患者需要手术切除病变，并对破坏的结构进行重建和固定，以维持颅颈交界区的结构完整和稳定，维护正常的生理功能。
因寰枢椎位于颅颈交界区，其解剖结构特殊，部位深在，周围有重要的神经中枢和血管，其切除和重建手术均是脊柱外科的难点。主要体现在：手术显露比较困难，要切除寰枢椎病灶，一般需要采用经口咽入路，如果病变范围较大，或重建固定的范围大，则可能需要采用劈开下颌骨等创伤更大的手术入路，而这一手术显露常常需要口腔科的医生配合完成。 手术操作风险大，寰枢椎的椎管内容纳着高位颈脊髓和延髓，切除病灶需要高超的外科技术，稍有不慎，损伤延髓有瘫痪和死亡的危险。寰枢椎周围还有椎动脉等重要血管，一旦损伤，可导致小脑梗死或死亡的后果。 病灶切除后，脊柱结构重建困难。目前临床上使用的脊柱内固定器材有后路的椎弓根钉棒，颈椎前路钢板等。但这些固定器材主要针对下颈椎设计，普通的颈椎钛板不适合寰枢椎固定。普通的钛网呈上下一致的圆柱形，也无法满足寰枢椎复杂解剖形状的重建需要。虽然国内外一些学者对钛网等植入物进行改良，并应用于寰枢椎切除后的重建，但改良的植入物应用于该部位手术，仍存在固定困难，形状匹配差，术后内固定失败率高，融合率低等缺陷，难以真正满足复杂手术需要。
发明内容
为解决上述问题，本发明提供一种固定容易，形状匹配好，术后内固定失败率低，融合率高，能够满足复杂手术需要的人工枢椎支撑体。
本发明解决其技术问题所采用的技术方案是：一种人工枢椎支撑体，包括支撑本体，所述支撑本体包括可与寰椎的下关节面形成接触和支撑的冠部和可与第三颈椎形成接触和支撑的体部，所述冠部的顶面形成可与寰椎的下关节面紧密贴合的顶部仿形面，所述体部的底面形成可与第三颈椎形的上关节面紧密贴合的底部仿形面，所述支撑本体的内部形成空腔，所述空腔内设有微孔网格支架，所述空腔在支撑本体的表面形成多个窗口，所述体部的底端设有下固定耳，所述冠部的顶端设有上固定耳，所述上固定耳和下固定耳上均设有固定孔，所述支撑本体可通过穿过上固定耳上的固定孔的螺钉与寰椎紧固连接，所述支撑本体可通过穿过下固定耳上的固定孔的螺钉与第三颈椎紧固连接。
进一步作为本发明技术方案的改进，所述支撑本体内具有贯通顶部端面和底部端面的空腔，环绕空腔的内壁设有微孔网格支架，微孔网格支架内形成贯通顶部端面和底部端面的通孔。
进一步作为本发明技术方案的改进，所述冠部、体部、微孔网格支架、上固定耳和下固定耳为通过3D打印制造的一体成型件。
进一步作为本发明技术方案的改进，所述空腔在所述支撑本体的前表面、后表面、左表面、右表面、上表面和下表面上均形成窗口。
进一步作为本发明技术方案的改进，所述上固定耳设置两个，并分别由冠部后壁的左、右两翼向上伸出，所述下固定耳由体部后壁向下伸出，下固定耳上设有两个一上一下错开分布的固定孔。
进一步作为本发明技术方案的改进，上固定耳和下固定耳上分别于对应固定孔的孔口处设有碗形槽，螺钉可在碗形槽内灵活调整方向。
进一步作为本发明技术方案的改进，所述上固定耳和下固定耳上分别于对应固定孔的孔口一侧设有可锁紧内部螺钉的锁紧机构。
进一步作为本发明技术方案的改进，锁紧机构包括开设在各固定孔孔口一侧的凹槽以及可转动的安装于凹槽内并可部分罩在固定孔孔口的压帽，压帽的顶部端面设有扭转凹槽，所述压帽上设有供螺钉取放的缺口。
进一步作为本发明技术方案的改进，还包括上固定耳钻孔导板和下固定耳钻孔导板，所述上固定耳钻孔导板具有可与寰椎外侧表面贴合的内表面，所述上固定耳钻孔导板的外表面设有向外伸出的上钻孔导管，所述上钻孔导管对应两上固定耳上的固定孔设置两根，上钻孔导管指向寰椎椎弓根方向，所述下固定耳钻孔导板具有与第三颈椎外侧表面贴合的内表面，所述下固定耳钻孔导板的外表面设有向外伸出的下钻孔导管，所述下钻孔导管对应下固定耳上的两个固定孔设置两根，下钻孔导管指向第三颈椎的椎弓根方向。
进一步作为本发明技术方案的改进，上固定耳钻孔导板和下固定耳钻孔导板均为通过3D打印制造的一体成型件。
本发明的有益效果：应用本人工枢椎支撑体手术时，分别在寰椎和第三颈椎外表面能建立寰椎逆向椎弓根螺钉通道和第三颈椎逆向椎弓根螺钉通道，选择合适型号大小的人工枢椎支撑体，置入骨缺损区域，支撑本体通过穿过上固定耳上的固定孔的螺钉与寰椎逆向椎弓根螺钉通道紧固连接，支撑本体可通过穿过下固定耳上的固定孔的螺钉与第三颈椎逆向椎弓根螺钉通道紧固连接，此时，人工枢椎支撑体在冠部的顶面形成由肩部到中间逐渐向上隆起的弧面，支撑本体通过所述弧面可与寰椎的下关节面形成接触和支撑，通过体部的底面与第三颈椎的上关节面形成接触和支撑，上下两端形成解剖贴合，完全模拟人枢椎的结构和形状，可以完美填充肿瘤切除后留下的缺损，并有效发挥支撑功能，其支撑和重建稳定性好，避免手术后假体的松动和失败，固定容易，形状匹配好，术后内固定失败率低，融合率高，能够满足复杂手术需要，同时，其采用仿松质骨的多微孔设计，方便新骨的长入。假体中心采用可填充自体骨材料设计，增加诱导成骨的成功率。
附图说明
下面结合附图对本发明作进一步说明：
图1是本发明实施例结构轴测图；
图2是本发明实施例结构主视图；
图3是本发明实施例结构后视图；
图4是本发明实施例使用状态结构示意图；
图5是本发明上固定耳钻孔导板结构示意图；
图6是本发明下固定耳钻孔导板结构示意图。
具体实施方式
参照图1至图6，其显示出了本发明之较佳实施例的具体结构。以下将详细说明本发明各元件的结构特点，而如果有描述到方向( 上、下、左、右、前及后) 时，是以图2所示的结构为参考描述，但本发明的实际使用方向并不局限如此。
目前商品化的骨科内植物包括常用的椎弓根螺钉、钛棒、钛网和人工椎体等。采用的是统一规格，批量生产。用于颈、胸、腰椎等部位的螺钉和钛网形状结构完全一致，只是根据不同部位加以放大缩小的尺寸变化而已。这对于形状均为柱形的规则脊柱而言是适用的。但对寰椎而言，普通钛网的圆柱形状即使改变尺寸，也难以满足重建手术需要。采用计算机仿真技术，模拟枢椎切除手术后留下的缺失区，如果植入一枚常规钛网，其下方尚能与第三颈椎上终板贴合，但钛网的上方无法与寰椎的侧块关节面形成解剖贴合，其支撑和重建是不稳定的，必然导致手术后假体的松动和失败。
金属3D打印技术的出现，为设计和定制复杂脊柱手术植入物提供了可能。所谓3D打印技术，是一种通过金属或非金属材料粉末层层堆积，逐步成型的方法获得三维立体结构的新型工业制造技术。其优点是，只要是计算机能够设计出的3维结构和零件，均可以转化成STL文件导入3D打印机完成快速制造。3D打印技术是近代工业的一个革命性的发明成果，该技术不仅在工业设计和艺术设计等领域具有广泛的应用价值，在近10年间，这一技术已经逐步进入医学领域，在硬组织外科，尤其是骨外科手术辅助方面发挥了越来越重要的作用。比如，对一些复杂的骨科手术，我们可以通过3D打印获得患者的骨骼模型，用于手术方案的设计和规划，而且还可以设计专门的手术导板，用于辅助手术。金属3D制造技术的出现，意味着目前在骨科广泛应用的植入材料和内固定器械，将可以根据不同患者及不同的手术部位实现个性化设计和定制，这种全新的理念将给骨科手术植入物的生产制造带及外科手术的发展带来一场革命。
本发明充分发挥医工结合的优势，设计一种完全符合枢椎解剖形状特征的多孔钛合金重建假体，该人工枢椎不仅具备理想的支撑功能，而且融合一体化的颈1和颈3钢板螺钉固定系统。通过个性化定制的导向器来引导寰椎螺钉及颈3的逆向椎弓根螺钉实施坚强可靠的前路固定来满足手术的需要，以期获得最佳的力学性能。
具体的，参照图1-图4，本发明提供了一种人工枢椎支撑体，包括支撑本体1，所述支撑本体1包括可与寰椎2的下关节面形成接触和支撑的冠部和可与第三颈椎3形成接触和支撑的体部，所述冠部的顶面形成可与寰椎2的下关节面紧密贴合的顶部仿形面，所述体部的底面形成可与第三颈椎形3的上关节面紧密贴合的底部仿形面，所述支撑本体1的内部形成空腔，所述空腔内设有微孔网格支架4，所述空腔在所述支撑本体1的前表面、后表面、左表面、右表面、上表面和下表面上均形成窗口11。窗口11和微孔网格支架4为接触面的骨长入提供支架和空间。所述体部的底端设有下固定耳5，所述冠部的顶端设有上固定耳6，所述上固定耳6和下固定耳5上均设有固定孔，所述支撑本体1可通过穿过上固定耳6上的固定孔的螺钉7与寰椎2紧固连接，所述支撑本体1可通过穿过下固定耳5上的固定孔的螺钉7与第三颈椎3紧固连接。
具体的，所述支撑本体1内具有贯通顶部端面和底部端面的空腔，环绕空腔的内壁设有微孔网格支架4，微孔网格支架4内形成贯通顶部端面和底部端面的通孔。所述冠部、体部、微孔网格支架4、上固定耳6和下固定耳5为通过3D打印制造的一体成型件。本发明可采用计算机三维重建及特征提取技术设计个性化仿真颈椎植入物，完全符合个体化颈椎手术需要。同时，采用金属3D打印制造技术快速制备假体，是增材制造技术，突破传统的减材机械加工制造技术的不足。
其中，所述上固定耳6设置两个，并分别由冠部后壁的左、右两翼向上伸出，所述下固定耳5由体部后壁向下伸出，下固定耳5上设有两个固定孔，两个固定孔一上一下错开分布，避免两个固定孔内的螺钉相互干扰。上固定耳6和下固定耳5上分别于对应固定孔的孔口处设有碗形槽，螺钉可在碗形槽内灵活调整方向。所述上固定耳6和下固定耳5上分别于对应固定孔的孔口一侧设有可锁紧内部螺钉的锁紧机构，锁紧机构包括开设在各固定孔孔口一侧的凹槽以及可转动的安装于凹槽内并可部分罩在固定孔孔口的压帽8，压帽8的顶部端面设有扭转凹槽，扭转凹槽采用多边形或十字形，所述压帽8上设有供螺钉取放的缺口81，需要将螺钉7置入时通过扭转凹槽转动压帽8，使缺口81避开固定孔孔口，当螺钉7紧固完成后，扭动压帽，压帽压紧螺钉，避免其松脱。
参照图5、图6，还包括上固定耳钻孔导板91和下固定耳钻孔导板92，上固定耳钻孔导板91和下固定耳钻孔导板92均为通过3D打印制造的一体成型件。所述上固定耳钻孔导板91具有可与寰椎外侧表面贴合的内表面，所述上固定耳钻孔导板91的外表面设有向外伸出的上钻孔导管93，所述上钻孔导管93对应两上固定耳6上的固定孔设置两根，上钻孔导管93指向寰椎椎弓根方向，指引上固定耳6的螺钉能够经寰椎侧块进入寰椎椎弓根。所述下固定耳钻孔导板92具有与第三颈椎3外侧表面贴合的内表面，所述下固定耳钻孔导板92的外表面设有向外伸出的下钻孔导管94，所述下钻孔导管94对应下固定耳5上的两个固定孔设置两根，下钻孔导管94指向第三颈椎3的椎弓根方向。指引下固定耳5的螺钉能够经第三颈椎3椎体进入椎弓根内。由于寰椎2和枢椎周围都是重要的神经与血管，螺钉7必须精确植入寰椎及第三颈椎3的椎弓根，才能有效避免血管神经损伤。本技术采用逆向工程技术，设计计算机辅助上固定耳钻孔导板和下固定耳钻孔导板，指导螺钉钉道的建立和安全植钉，保证螺钉按照术前的设计意图精确安全的植入椎骨内，不损伤神经和血管。
手术时：
1.患者取仰卧位，肩膀下方垫高，头后仰，连接颅骨牵引，尽可能保证寰椎在复位状态下实施手术。
2.手术前用洗必泰，碘伏，生理盐水反复冲洗口腔，消毒，铺单。取咽后壁正中切口，切开粘膜和粘膜下肌层，改用电刀向两侧剥离颈前肌肉，显露寰椎前弓，侧块及枢椎前方的椎体及两侧的侧块关节。
3.用电刀切开松解双侧的寰枢椎侧块关节囊，保留外侧四分之一，注意椎动脉走行，避免损伤。
4.剥离第一至第三颈椎前方的软组织，充分显露第一至第三颈椎的前方结构。
5.将寰椎的上固定耳钻孔导板固定在寰椎表面，并紧密贴合，顺上钻孔导管方向钻孔建立寰椎逆向椎弓根螺钉通道。
6.同上方法，将第三颈椎的下固定耳钻孔导板固定在第三颈椎表面，并紧密贴合，顺下钻孔导管方向钻孔建立第三颈椎的逆向椎弓根螺钉通道。
7.用高速磨钻等工具将第二颈椎彻底切除，并仔细止血。
8.将支撑本体植入第二颈椎切除后的缺损区内，并选择合适长度的螺钉拧入预先准备的螺钉通道进行固定。
当然，本发明创造并不局限于上述实施方式，熟悉本领域的技术人员在不违背本发明精神的前提下还可作出等同变形或替换，这些等同的变型或替换均包含在本申请权利要求所限定的范围内。

Claims (5)

1.一种人工枢椎支撑体，其特征在于：包括支撑本体，所述支撑本体包括可与寰椎的下关节面形成接触和支撑的冠部和可与第三颈椎形成接触和支撑的体部，所述冠部的顶面形成可与寰椎的下关节面紧密贴合的顶部仿形面，所述体部的底面形成可与第三颈椎形的上关节面紧密贴合的底部仿形面，所述支撑本体的内部形成空腔，所述空腔内设有微孔网格支架，所述空腔在支撑本体的表面形成多个窗口，所述体部的底端设有下固定耳，所述冠部的顶端设有上固定耳，所述冠部、体部、微孔网格支架、上固定耳和下固定耳为通过3D打印制造的一体成型件，所述上固定耳和下固定耳上均设有固定孔，所述支撑本体可通过穿过上固定耳上的固定孔的螺钉与寰椎紧固连接，所述支撑本体可通过穿过下固定耳上的固定孔的螺钉与第三颈椎紧固连接，所述上固定耳设置两个，并分别由冠部后壁的左、右两翼向上伸出，所述下固定耳由体部后壁向下伸出，下固定耳上设有两个固定孔，两个固定孔一上一下错开分布，上固定耳和下固定耳上分别于对应固定孔的孔口处设有碗形槽，螺钉可在碗形槽内灵活调整方向，所述上固定耳和下固定耳上分别于对应固定孔的孔口一侧设有可锁紧内部螺钉的锁紧机构，锁紧机构包括开设在各固定孔孔口一侧的凹槽以及可转动的安装于凹槽内并可部分罩在固定孔孔口的压帽，压帽的顶部端面设有扭转凹槽，所述压帽上设有供螺钉取放的缺口。
2.根据权利要求1所述的人工枢椎支撑体，其特征在于：所述支撑 本体内具有贯通顶部端面和底部端面的空腔，环绕空腔的内壁设有微孔网格支架，微孔网格支架内形成贯通顶部端面和底部端面的通孔。
3.根据权利要求1或2所述的人工枢椎支撑体，其特征在于：所述空腔在所述支撑本体的前表面、后表面、左表面、右表面、上表面和下表面上均形成窗口。
4.根据权利要求1所述的人工枢椎支撑体，其特征在于：还包括上固定耳钻孔导板和下固定耳钻孔导板，所述上固定耳钻孔导板具有可与寰椎外侧表面贴合的内表面，所述上固定耳钻孔导板的外表面设有向外伸出的上钻孔导管，所述上钻孔导管对应两上固定耳上的固定孔设置两根，上钻孔导管指向寰椎椎弓根方向，所述下固定耳钻孔导板具有与第三颈椎外侧表面贴合的内表面，所述下固定耳钻孔导板的外表面设有向外伸出的下钻孔导管，所述下钻孔导管对应下固定耳上的两个固定孔设置两根，下钻孔导管指向第三颈椎的椎弓根方向。
5.根据权利要求4所述的人工枢椎支撑体，其特征在于：上固定耳钻孔导板和下固定耳钻孔导板均为通过3D打印制造的一体成型件。
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