CN101478913A - 在脊柱中模板化和置入假体椎间盘 - Google Patents

在脊柱中模板化和置入假体椎间盘 Download PDF

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CN101478913A
CN101478913A CNA2007800234939A CN200780023493A CN101478913A CN 101478913 A CN101478913 A CN 101478913A CN A2007800234939 A CNA2007800234939 A CN A2007800234939A CN 200780023493 A CN200780023493 A CN 200780023493A CN 101478913 A CN101478913 A CN 101478913A
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intervertebral disc
space
prosthetic
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prosthetic intervertebral
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赫克托·O·帕切科
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Abstract

一种在所选脊柱区域内确定相邻椎骨的终板之间的椎间隙(disc space)中置入的人工椎间盘的尺寸和/或位置的方法，包括：用计算机确定该椎间隙的参数，该参数包括相邻椎骨的终板之间的椎间隙的高度、宽度、深度及前弯度(lordosis)；用计算机创建一个与实际的人工椎间盘相匹配的人工的空间，该人工椎间盘能够被置入与制造商的尺寸和前弯度规格相一致的椎间隙；用计算机确定该椎间隙的中心和假体椎间盘空间(prosthetic disc volume)的旋转中心；用计算机将该假体椎间盘空间置入到椎间隙，使得该假体椎间盘空间的旋转中心位于该椎间隙中心的后方；按照外科医生或者制造商的假体规格，用计算机确定该假体椎间盘空间与该椎间隙相符。

Description

在脊柱中模板化和置入假体椎间盘
相关申请的交叉引用
本申请案要求2006年6月28日提交的美国临时申请第60/816,882号的优先权。
发明背景
1.技术领域
本发明涉及人工椎间盘的模板化(templating)和置入，尤其涉及一种新的、改进的能够让医生选择人工椎间盘的最优尺寸并将其精确置入到椎骨间以提升其动态功能的装置和方法。
2.背景技术的描述
人椎间盘的退变已越来越多使用假体椎间盘来治疗。一个成功的外科手术的决定性因素是在脊柱人工椎间盘置换手术中对假体椎间盘进行适当的模板化和置入。对模板化来说，重要的参数有高度、宽度、深度和前弯度。对置入来说，有不同的方法来置入这些人工椎间盘。具体地，这些人工椎间盘能够被前置，侧置或者后置，最普遍的方法是前置法。置入该假体椎间盘一个关键部分是其置入的前后位置，因为这决定了该假体的旋转中心及其动态功能，如果该假体被置入到了椎间隙旋转中心的前面，那该假体实质上就成为了一个刚性装置。当假体的即时旋转中心在实际椎间隙的中心后部的椎间隙的后三分之一时，这时该假体处于一个理想的位置。通常在手术时选择适当的人工椎间盘置入尺寸的模板，随后通过荧光镜检查法或者其它图像引导法来辅助置入假体椎间盘。
到目前为止，多数关于模板化和置入的专利系统及方法，都是在手术时由外科医生手工操作的。就目前的情况而言，没有可以自动确定理想的高度、宽度、深度及前弯度或者人工椎间盘假体的实际置入位置的装置和系统。
发明概述
本发明能够自动的生成表格，该表格包含了实际椎间隙和单个的假体(人工椎间盘)的高度、宽度、深度和前弯度的数据，并同时提供示意图，该示意图显示单个椎间隙的数据。这种方法实际上确立了两个在尺寸上真正不同的空间(volumes)。具体的，这种方法建立了该椎间隙的实际空间并且包含了假体椎间盘建立的空间。该空间分别被展示并且被合并在一起以便于外科医生选择理想的假体椎间盘。合并的空间的图像有一个关键的特征量来保障理想的假体置入尺寸和位置并通过假体椎间盘的关节活动度来优化该假体椎间盘的动态功能，即空间中旋转中心的坐标。外科医生可以利用该数据并通过如下四种方法之一来进行实际的假体椎间盘的置换：1.方法A：采用外科医生偏好的方法来手动置入人工椎间盘；2.方法B：利用椎弓根基部圆周轮廓线法，该方法和术中荧光图像相结合；3.方法C：利用双环矫正装置和钻导法；和4.方法D：使用任何商业上可获得的计算X断层扫描技术/荧光套准软件。这些方法在本发明得以体现。
附图简述
图1a和1b分别展示了三维计算机图像的侧面和后面，该图像是通过对所选脊柱区域的椎骨进行CT、MRI或其它研究方式而形成的；
图2是从如图1a和1b所示的脊柱区域经人工切除后的单节椎骨的三维计算机图像；
图3是两个邻近的椎骨及其间的椎间隙的冠状面示意图；
图4是图3所示椎骨的径向面示意图；
图5是图3和4所示上部椎骨的横截面示意图；
图6是一个位于椎间盘空间里的假体椎间盘的立体示意图，该椎间盘空间位于图3、4和5所示的邻近的椎骨之间；
图7是图3-5所示椎骨置入了图6中的假体椎间盘之后的冠状面示意图；
图8是图7所示椎骨和假体椎间盘的径向面示意图；
图9是图7和8所示椎骨和假体椎间盘的横截面平面示意图；
图10是和图7类似的冠状面视图，显示了假体椎间盘的旋转中心和椎骨间的椎间隙的中心；
图11是和图8类似的径向面视图，显示了假体椎间盘的旋转中心和椎骨间的椎间隙的中心；
图12是和图9类似的横截面视图，显示了假体椎间盘的旋转中心和椎骨间的椎间隙的中心；
图13是椎骨的径向面示意图，显示了椎弓根基部圆周的内侧中心(medialcenter)；
图14是图13所示的椎骨的横截面示意图，显示了椎弓根基部圆周的内侧中心和椎弓根的峡部；
图15是图13和14所示椎骨的冠状面示意图，显示了椎弓根基部圆周的内侧中心；
图16是椎骨的径向面视图，显示了椎弓根基部圆周的内侧中心和通过终板径向中心的前点及后点(anterior and posterior points)；
图17是图16所示椎骨的横截面示意图；
图18是图16和17所示椎骨的冠状面示意图；
图19是生成的材积表的部分示意图，用冠状面、径向面和轴(或者横截面)视图显示了椎骨间隙中的假体椎间盘的位置；
图20是一个表格，显示了可能依照本发明生成的椎间隙的最大尺寸参数；
图21是邻近椎骨(in elevation of)的径向面示意图，显示了椎弓根基部圆周的内侧中心和位于椎骨间隙中的假体椎间盘；
图22是图21所示椎骨的冠状面示意图；
图23是图21和22所示椎骨的横截面示意图，并且包括了从冠状面主视图可以看到的后外侧角(posterolateral corners)的椎弓根基部圆周；
图24是椎间盘空间的立体示意图，为便于对假体椎间盘进行置入和矫正，显示了该椎间盘空间的中心线；
图25是邻近椎骨的冠状平面的示意图，显示了按照本发明的一种方法置入椎间隙中假体椎间盘的步骤；
图26是与图14类似的立体示意图，显示了一个采用了双环矫正装置的假体椎间盘空间；
图27是由计算机生成的假体椎间盘空间的示意图，该假体椎间盘空间有一条中心线和一个环绕的矫正环；
图28a和28b分别是本发明钻孔套管部分第一实施例的尾部的侧视图和正视图，该套管部分用于图26的双环矫正装置；
图29a和29b分别是是本发明钻孔套管部分第二实施例的尾部的侧视图和正视图，该套管部分用于图26的双环矫正装置；
图30是和图27类似的示意图，显示了一个槽形外套管，其环绕在图26的环上。
优选实施方式的描述
本发明中关于模板化和置入假体椎间盘的方法和装置将在下面详细描述。
步骤1
首先通过计算机断层扫描(CT)、磁共振成像(MRI)、CT荧光透视或类似的二维图像研究获取待查脊椎区域的信息。最好为薄切片区，这样有助于提高精确度和获取更多细节信息。
步骤2
通过CT、MRI或其它合适的方式得到脊椎骨的计算机三维真实图像，如图1a和图1b所示。
步骤3
利用图2-5所示的单节椎骨的三维图像确定椎间盘空间的参数，这些参数有邻近两个椎骨终板间的高度H、宽度W、深度D和前弯度θ。图4中的B表示椎弓根基部圆周，X表示椎弓根的峡部。
步骤4
如图6-9所示，然后计算机创造一个与实际的假体椎间盘相一致人工空间2，该实际的假体椎间盘根据制造商的尺寸和推荐的假体前弯度来置入，并根据该人工空间2自动决定最大允许的假体椎间盘尺寸。例如：一个制造商的假体可能需要两毫米的前嵌入物(anterior inset)，而另一个制造商的假体可能需要三毫米的前嵌入物。多个制造商在假体的制造上的推荐标准是不同的，这些不同包括高度、宽度、深度和前弯度四个参数。另外，为了保证假体椎间盘不至于过大，最大的人工椎间盘空间的旋转中心必须被限制在位于椎间隙4的中心8之后，理想地是假体被完全置入后位于中心8的后三分之一的位置。如图10-12所示，采用椎弓根基部圆周轮廓线法可以确定椎间隙4的中心的距离，这会在下面全面描述。人工假体椎间盘空间2会与实际的椎间盘空间4相符，除非外科医生希望指定的更改高度和前弯度。人工椎间盘有两种主要的设计方法，可以将其作为一个整体化装置来设计，或者是作为多个部分的组合来设计。
步骤5
如图13-18所示，椎弓根基部圆周轮廓线法利用计算机生成一个显示椎弓根基部圆周B的图像，该椎弓根基部圆周B定义为椎弓根壁和它过渡到脊椎体的皮层接合点。该椎弓根基部圆周在术中被标识在平面X射线图像和荧光图像上，通常在前后方向能看到椎体的上侧面的圆形皮层轮廓线。利用椎体的弓根基部圆周B的内侧中心PB1或者PB2作为参考点，那么一条连接点PB1和PB2的直线可以被绘制出来。根据该直线，绘制一个垂直于直线PB1-PB2径向平面SP。各个椎骨的终板E和径向平面SP的交叉确定了前点A和后点P，两点之间的距离是通过径向中心的终板的距离。A-P两点之间距离的二分之一(1/2A-P)处是椎体终板的中心点C。该中心点C描述的是实际的椎间盘空间单个及其合并后的空间图像分析。
步骤6
对于那些外科医生想恢复其丢失的高度和前弯退变的椎间盘来说，计算机能够修正该人工椎间盘空间以将这些期望的变化具体化，同时将这些变化包括在理想化的材积示意表(schematic volume table)中。
步骤7
然后计算机提供一个数据汇总表(如图19和20)，该表显示了每个椎间隙理想假体椎间盘的高度、宽度、深度和前弯度数据，同时提供一个理想化的示意图，该示意图分别显示了实际椎间盘空间和假体椎间盘空间，同时显示了上述二者合并后的图像。这些空间将包括可视化的中心点。先让外科医生确定任何具体的椎骨，并标记所确定的单个椎骨，然后计算机自动的标记剩下的椎体，并经外科医生确认准确的椎骨标记。
步骤8—方法A：手动置入人工椎间盘
外科医生利用理想化的示意图和汇总数据来并采用偏好的有用功来手动置入假体椎间盘。
步骤9—方法B：椎弓根基部圆周轮廓线法
此方法利用了一个由计算机生成的显示椎弓根基部圆周B的图像，该椎弓根基部圆周B定义为椎弓根墙间的并过渡到椎体的皮质交界处。该椎弓根基部圆周在术中被标识在平面X射线和荧光图像中，该椎弓根基部圆周在术中被标识在平面X射线图像和荧光图像上，通常在前后方向能看到椎体的上侧面的圆形皮层轮廓线。
这是一个能够用于人工椎间盘的置入的始终如一的X光的标识。可以利用荧光透视排列各个单节脊椎体的上端面，使其平行于所述荧光透视图像。此外，，此过程中同样利用了具有头部脊椎体的脊椎体上端面用对称椎间隙荧光透视形象化。具有头部脊椎体的脊椎体上端面通常用椎间隙荧光透视形象化，当在荧光镜AP图中的椎骨的中心和每个椎弓根基部圆周距离相等时，脊椎体居中置入。
假体椎间盘的嵌入可以采用前置、侧置或者后置的方法。假体椎间盘的最后面位于与连接椎弓根基部圆周的内侧中心PB1-PB2的椎弓根基部圆周一样的平面上。因此，假体椎间盘2的上-下后外侧角PLC能够被标记，以此来在荧光镜光下的AP视图标识该椎弓根基部圆周，并且可以在侧视图得到确认，如图21-23所示。
步骤10—方法C：双环矫正装置和钻导法
在手术中自动的置入假体椎间盘时，可以利用真实尺寸的三维脊椎模型，该模型具有计算机自动生成的假体椎间盘空间。另外，从假体椎间盘空间2的中心点C引出一条直线，该直线延伸到表面的中心点F，采用该法的椎间盘将被插入以创造一个假体椎间盘空间，该假体椎间盘空间具有指向外部并经过前面FA、后面FP或者后面FL的直线，如图24所示。
步骤11
参考图25，采用术中实时透视来精确套准假体椎间盘空间和单节椎体基部的三维模型。这种荧光透视的椎体成像被集中在监控器上，并由外科医生鉴别出特别的椎体(例如L4，L5等)。相应的具有真实尺寸的三维单节椎体模型与荧光透视图像套准。上述步骤可以在如外科手术般的暴露的脊柱上进行或经由皮肤进行。。
步骤12
该套准是利用内部椎体骨性标记进行，这些标记是荧光透视成像中所见的椎弓根基部圆周B，该圆周起于椎弓根皮层壁连接脊椎体的汇合处。如前文所述，这些椎弓根基部圆周形成圆形或是椭圆形，基于椎体的相对于荧光透视成像中的旋转，可以改变其外形和平方面积。
步骤13
然后，手术中的荧光透视图像和计算机生成的椎弓根基部圆周轮廓进行套准，通过确保轮廓线重叠和测量的平方面积相等及确保椎弓根间距离相等来获得套准的精确度。这种套准方法消除了将X光线成像标记锚定在病人骨骼上的要求。这种方法还允许一个椎体自由独立地向另一个椎体移动，来展示计算机产生的模型的符合性，所述方法在不稳定脊柱中尤其有用。外科医生在手术中确认椎弓根基部圆周的充分套准，以此进行假体椎间盘的置入。所述方法允许计算机生成的模型增大或减小，以匹配手术中的荧光透视成像。
步骤14
参考图26和11，现在包括计算机生成的椎弓根基部圆周、假体椎间盘空间2和中间线L的完整的三维图像被投射到手术中的荧光透视成像上。然后，计算机生成的假体椎间盘空间2穿过椎间隙并凸出到病人体外，并被两个分离的同线环R1、R2截取及延伸穿过该同线环R1、R2。该环安装在一个锚定在病床的装置上(未显示)，环的尺寸大到允许截取计算机空间图像和将锥子套管插入。
第一个环R1在椎间隙的皮层区域附近截取计算机生成的假体椎间盘空间，第二个环R2在距第一个环R1任意期望的距离处截取计算机生成的假体椎间盘空间。两环间的距离越长，假体椎间盘置入的精度越高。环对计算机生成的假体椎间盘空间的截取是手动进行的，并实时显示在计算机上显示器上，以展示环相对于计算机生成的假体椎间盘空间的移动。
步骤15
假体椎间盘空间的截取发生在两个层面上。电脑生成的假体椎间盘空间包括带有周围空间的中心线L。首先，环R1和R2需要环绕中心线L和其周围空间。第二，该环要与椎体套准以便在计算机上跟踪其移动。例如通过LED装置、EMF或者其它装置。第三，环的内部尺寸被设计成与计算机生成的假体椎间盘空间相匹配。有多个不同尺寸的环来供外科医生在人工椎间盘系统中使用，或者，环可被设计成孔径可变的环，以便于和计算机生成的假体椎间盘空间尺寸相匹配。计算机假体椎间盘空间与环的套准是在计算机监控器上被鉴别和确定的。
步骤16
所述同线环R1和R2现在形成了一个用来置入套管10的通道。该套管也被固定在锚定在病床的装置上。在套管10内设有一个坚固的钻孔套管12或一个特别的内部钻孔套管14，该特别的钻孔套管内具有多个窄小的平行的金属杆16，其中部是空的，可以置入锥子。这些金属杆16可以让内部套管14平稳地放置在不平坦的表面上。这种特征在后皮层钻孔区域提供了额外的稳定性以避免钻子被拴牢。另外，特别的内部钻孔套管允许这些金属杆缩回，从而荧光透视可以清楚的呈现椎间隙内的钻孔过程。外科医生可以使用任一种方式。当使用可变孔径法时，可以利用一个包含了两个分离的可变孔径的环的坚固套管。
步骤17
椎间隙被钻孔至预先校准的深度，且不超过预定的人工椎间盘深度。
步骤18
探测椎间隙以确保骨质的完整性。
步骤19
在实际的假体椎间盘的置入过程中，一种特别的槽形外套管18被安装与同线环R1和R2的同一条直线上，如图30所示。该特别的槽形外套管18也固定的连接到锚定装置。然后将环R1和R2从槽形外套管18上移除。槽形外套管的内部尺寸大到足以容纳任意假体椎间盘。适当的假体椎间盘被放入承载它的螺丝起子(未显示)，置入该槽形外套管18，然后置入各自的椎间隙。对于孔径可变环，其孔径完全开放，以便于承载适当假体椎间盘的螺丝起子的置入。
步骤20
对所有期望的椎间隙重复上述步骤。
步骤21
现在有商业可利用的软件包能够将病人手术前的三维脊椎图像与手术中荧光透视图像在手术中套准。这种功能与本发明的方法相结合，可以提供汇总的数据资料和理想化的图表。后面的信息将为实际假体椎间盘的置入提供基础，这如前文所述或根据医生的优先选择。
以上所揭露的仅为本发明的较佳实施例而已，当然不能以此来限定本发明之权利范围，因此依本发明申请专利范围所作的等同变化，仍属本发明所涵盖的范围。

Claims (16)

1、一种在所选脊柱区域内确定相邻椎骨的终板之间的椎间隙中置入的人工椎间盘的尺寸和/或位置的方法，包括：用计算机确定该椎间隙的参数，该参数包括相邻椎骨的终板之间的椎间隙的高度、宽度、深度及前弯度；用计算机创建一个与实际的人工椎间盘相匹配的人工的空间，该人工椎间盘能够被置入与制造商的尺寸和前弯度规格相一致的椎间隙；用计算机确定该椎间隙的中心和假体椎间盘空间的旋转中心；用计算机将该假体椎间盘空间置入到椎间隙，使得该假体椎间盘空间的旋转中心位于该椎间隙中心的后方；按照外科医生或者制造商的假体规格，用计算机确定该假体椎间盘空间与该椎间隙相符。
2、如权利要求1所述的方法，其特征在于，上述椎间盘的中心由以下方法确定：标识一节椎骨的椎弓根基部圆周的内侧中心点，创建一条连接这些中心点的直线，并创建一个垂直于上述直线的径向平面，使得该径向平面与椎骨终板相交于一个前点和一个后点，将此两点沿径向平面的距离的二分之一处标识为椎间隙中心。
3、如权利要求1所述的方法，其特征在于，利用计算机生成表格，显示椎间隙和假体椎间盘空间的高度、宽度、深度和前弯度的数据。
4、如权利要求3所述的方法，其特征在于，利用计算机生成示意图，为不同的椎间隙标识出数据。
5、如权利要求1所述的方法，还包括：标识出一节椎骨的弓根基部圆周的内侧中心点，在这些中心点之间创建一条直线，标识出所述假体椎间盘空间的角，并利用计算机将所述假体椎间盘空间的角和所述直线套准，以便于位于椎间隙的所述假体椎间盘的置入。
6、如权利要求1所述的方法，还包括：在手术中利用真实尺寸的三维脊椎模型自动的置入假体椎间盘。
7、如权利要求6所述的方法，其特征在于，计算机生成一条从所述假体椎间盘空间的旋转中心延伸出来的直准线，该直准线通过所述假体椎间盘空间的前面、后面或者侧面。
8、如权利要求7所述的方法，其特征在于，利用术中实时透视将所述假体椎间盘空间和三维脊椎模型精确套准。
9、如权利要求6所述的方法，其特征在于，所述生成的准线和延伸的假体椎间盘空间被两个分离的同线环R1、R2截取及延伸穿过该同线环R1、R2，该环安装在病床上的支架或者其它支持物上，其中一个环置于靠近所述假体椎间盘空间的位置，另一个环与该环向外隔开，所述环的内部尺寸和经扩展的假体椎间盘的尺寸大致相同，所述环提供一个和生成的假体椎间盘相对应的开口为钻孔套管导航。
10、如权利要求9所述的方法，其特征在于，所述环是活动安装在所述支架上。
11、如权利要求9所述的方法，其特征在于，所述环可从所述支架上移除。
12、如权利要求9所述的方法，其特征在于，可调整改变所述每一环的内部尺寸。
13、如权利要求9所述的方法，其特征在于，一钻孔套插入并穿过所述环的，该钻孔套管具有一个活动支撑钻孔元件的中心纵向开口。
14、如权利要求13所述的方法，其特征在于，所述钻孔套管安装在病床上或者其它支持物上，并且具有一个内部套管元件，活动支撑钻孔元件。
15、如权利要求14所述的方法，其特征在于，所述内部套管元件包括相互间隔的、平行的、纵向延伸的并且可移动的杆，所述杆形成了钻孔元件的中心开口；所述小杆可延伸超过钻孔套管的内端，从而在不平坦表面上提供稳定的支持。
16、如权利要求13所述的方法，其特征在于，所述环可移动安装在所述支架上，当中心开口被钻好、钻孔套管被移除后，具有纵向槽的第二套管装于所述环的外部，并固定于所述支架，从而其纵向轴与生成的假体椎间盘空间的纵向轴对应，所述假体椎间盘空间穿过所述环，所述环从所述第二套管移除后，所述第二套管引导假体椎间盘置入椎间隙。
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