CN101528122B - 一种用于***到椎弓根中的套管 - Google Patents
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Abstract
一种外科手术中在选定脊椎区域内确定放置螺钉或其它设备的大小和位置的方法,其包含了产生所选脊椎区域内脊椎体的三维真实图像;根据外科医生在进行外科手术时选择的皮层厚度在三维图象中挖空脊椎骨;确定每一个椎弓根的最窄横截面(峡);从峡中心产生一条直线,该直线向内延伸到前端皮层中心,这样该直线就能集中于椎弓根内部而不会接触到其中的壁;该条直线在距前内部皮层预定距离处的脊椎内部终止,并反向延长直至刺穿后椎弓根皮层;直线呈环形放射状扩充至交叉区域的尺寸,所述的这个尺寸要略小于峡的横截面尺寸,当被扩充的圆柱体中任何一部分接触到被挖空的脊椎体内除后椎弓根皮层外的皮层壁时停止变大,并根据每一个椎弓根产生圆柱体的尺寸和轨线来计算理想椎弓根螺钉或其它设备的直径,长度和/或轨线。此外,提供了一种新改进的用于进入椎弓根内部进行所需经关节操作的方法,并且还揭露了一种新改进的椎弓根套管的构造。
Description
本专利申请要求2005年3月7日申请的美国临时专利申请第60/658,576号的优先权。
技术领域
本发明总体上涉及脊柱外科手术技术领域,尤其涉及一种在脊柱外科手术过程中精确地确定椎弓根螺钉或其它设备的尺寸和置入位置的人工、计算机控制或自动化方法。
背景技术
多种医疗情况对人类脊椎骨骼手术产生了影响。在越来越老龄化的群体中,有骨质疏松引起的脊椎骨压迫性骨折的人数在不断上升,造成在这些人群中的发病率和死亡率的大幅提高。治疗这些压迫性骨折的传统方法并不总是很有效。作为结果,用于强化脊椎骨的方法使得对患病病人的临床治疗有了显著的提升。通常手术多是采用椎体成形术,在椎体成形术中,常常通过经关节突入路、通过脊椎骨椎弓根、有时通过椎弓根根外突入路而将骨骼替代物比如有机玻璃、羟磷灰石混合物或其它材料材料注入脊椎骨中。对椎体成形术的改进就是椎体后凸成形术,在该成形手术中,球囊导管通过经关节突入路而被送入到脊椎体中,然后导管膨胀至几乎恢复原有脊椎骨结构。当导管放气后,留下一个空腔,然后空腔被类似于椎体成形术的材料填充满。这两种手术对病人手术都有极大好处,因为该两种手术经常借助经皮方法执行,该经皮方法考虑到 了门诊病人的管理,治疗过的病人偶尔会需要一个通宵病房监护。
椎体成形术和椎体后凸成形术的应用已拓宽至包括脊椎体瘤、创伤破裂骨折的管理,有时甚至包括了迫近骨折的预防管理。每种手术中的合格标准的一个重要要素是脊椎体必须有完整无缺的后脊椎体壁,以避免因治疗事故引起的注入材料向骨髓的泄漏。
为降低医疗事故损伤,制定了一系列的安全装置。其中的一些安全装置包括使用与注入材料混合的放射不透光对照材料,使得其在X光图像(荧光图像)下显现;在带有双平面荧光图像(前-后面图像和侧面图像)的可控环境下进行手术;将设备小型化,以避免椎弓根皮层壁破裂,对脊椎体采用双侧经关节突入路来扩大注入材料的容积;限制一次被注入的脊椎体的数目,使其小于等于三个;限制胸级4T4以下的脊椎体的椎体后凸成形术;和采用其它策略。
受益于例如椎体成形术、椎体后凸成形术的成功结果,脊椎组织检查、椎弓根螺钉置入或其它一些对脊椎体的进入路径能始终如一和可重复地进行。这个进入路径通常是经关节突入路,但也可通过椎弓根根外突入路进行。
本发明提供了一种安全以及可重复的方法,用于通过经关节突入路和椎弓根根外突入路而进入任何脊椎体。此外,还包括了特定的实施例,以便改善现有的椎体成形术、椎体后凸成形术、脊椎体检查以及椎弓根螺钉置入方法。本发明对这些手术中使用的X光图像减少至仅为前后荧光图像,同时本发明既能在经皮环境下又能在开放外科环境下以及无论有无椎弓根螺钉设备的情况下采用。
用于执行这些手术中的任何一个的关键参数是通过获取以下内容实现的:椎弓根的直径、长度、轨线和实际的设备和/或螺钉的置入位置。目前许多图像导航***允许人工确定这些参数,并许使用以提高外科医生在这些手术中的 人工性能。到目前为止,还没有发明或***,其将自动地确定椎弓根的理想直径、长度、轨线以及设备或螺钉的实际放置。
发明内容
本发明将自动生成表格,该表格提供最大允许的椎弓根直径及长度以及提供轨线的总结数据,并同时提供示意图,该示意图显示单个脊椎椎弓根的数据。外科医生可以用这些大量数据,采用如下方法之一来进行骨内经关节进入:(方法A)采用外科医生的偏好方法手动地进行设备或螺钉的置入。(方法B)利用椎弓根基部圆周轮廓法,该方法将长度可调整锥子与外科荧光图像相结合,或(方法C)采用双环对正设备和钻子导向的方法将设备或螺钉自动地置入,或(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。本发明同样允许骨外或椎弓根根外椎弓根设备或螺钉的置入(方法E),如果外科医生基于轨线而如此期望,该轨线始于前皮层的相同起点,但与外科医生期望的偏好或任何距离或角度在切向上形成一定角度。此外,本发明还允许设备或螺钉置入的轨线沿计划的偏轴置入继续前进,即经关节,但是以椎弓根峡为中心(方法F)。
本发明的其中一个方法主要包括以下步骤:
1.可以首先取得所感兴趣的脊柱区域的计算机断层扫描(CT)、磁共振成像(MRI)、CT荧光透视或类似的二维成像法形成的二维图像。
2.通过CT、MRI或其它方法,或用任何其它适合的方法生成脊柱的真实尺寸的三维计算机图像。
3.然后将计算机形成的单个脊椎体的三维图像用计算机或其它类似于一次经椎弓根椎体次切除的装置将其挖空,以便形成医生期望的规格,例如 剩余的椎体皮层或椎根壁的皮层壁厚度。单节脊椎体被形象化为一种去芯的或被挖空的结构,并且作为结果而剩余的脊椎体通过其壁部而显亮。
4.然后计算机在任何给定的外科医生偏好的椎弓根皮层壁的直径范围内,根据椎弓根的最窄直径或最小的截面区域(峡部)来自动地确定被置入螺钉或其它设备的最大允许直径。
5.然后计算机通过直线地从峡部中心开始而生成一个纵长圆柱,该圆柱确定了理想的轨线,并向例如垂直于椎弓根峡部所在平面的相反方向延伸,从而尽可能地使该圆柱同心地设置在椎弓根内部而不接触到剩余地显亮皮层。所述直线可以刺穿背部或后椎弓根皮层,从而使其能延伸到病人的皮肤外至任意所期望的长度。所述直线在椎体内部终止,以便位于外科医生的预定距离内,该距离从前内部皮层壁算起,从而使它不会刺穿前外部皮层。
6.然后计算机生成一个从峡部X中心开始沿直线伸长的圆柱,该直线投射到前脊椎体内的中心点,以便确定理想轨线并向相反方向延伸,同时并不接触剩下的显亮皮层。这条直线被允许刺穿脊或椎弓根后皮层,使得其能伸展直至超过病人的皮肤到任何所需长度。这条直线在脊椎体内终止,以便位于外科医生的预定距离内,该距离从前内部皮层壁算起,以保证不会刺穿它。
7.然后计算机在半径方向上将该直线同心地构建成最终的最大直径,所述最大直径不会超过基于外科医生偏好的皮层壁厚度而定义的最窄椎弓根直径。这种同心构建最后形成可视圆柱,当该圆柱外表面上的任意一点与显亮的内侧皮层壁接触时,该圆柱停止构建。然而,这种规律不能应用于毗邻已经存在的从峡部产生的直轨迹线的前皮层。
8.然后计算机通过测量圆柱的长度确定螺钉的长度,该圆柱始于椎弓根基部圆周,直到其与背/后皮层的交叉点。
9.然后计算机通过测量圆柱的长度确定螺钉的长度,该圆柱始于预定的前内皮层,直到其与背/后皮层的交叉点。根据此后描述的自动化方法中的以其中之一,为了使螺钉或设备的置入更容易,圆柱可以延长到超过其与背/后皮层的交叉点。
10.然后计算机提供一个数据汇总表和,该数据汇总表显示用于每个单个椎弓根的理想椎弓根螺钉或设备的直径、长度或轨线,及其理想化的示意图。
11.然后根据最大椎弓根螺钉或设备的直径和长度,利用列表的数据确定椎弓根螺钉或设备的生存能力,同样利用列表的数据按外科医生偏好的方法进行椎弓根螺钉或设备的置入。
附图说明
图1a和1b分别展示了三维计算机图像的侧面和后面图像,该图像是通过对所选脊柱区域的脊椎体进行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脊椎体的三维计算机图像。
图3是一个挖空的单节脊椎体的计算机图像,显示了椎弓根内最窄直径或横截面区域(峡部)。
图4是一个挖空的单节脊椎体的计算机图像,显示了穿过峡部中心并沿相反方向延伸穿过后椎弓根皮层及前内皮层的直线。
图5是圆柱形成的示意图,该圆柱是通过在半径方向同心地构建延伸穿过峡部中心的直线而形成的。
图6a和6b分别是挖空的对称和不规则形状的单节脊椎体的示意图。
图7a和7b分别是直的和弯曲的椎弓根的峡部的示意图。
图8是挖空的脊椎体的示意图,显示了用于确定椎弓根螺钉长度的圆柱的长度。
图9是单节脊椎体的侧视图,显示了外科医生为椎弓根螺钉的安装而标记的单节脊椎体。
图10a是一个由计算机生成的数据汇总表,该表包括最大椎弓根螺钉直径和长度,还包括椎弓根螺钉相对于径向面和横截面的轨线角度。
图10b是一个脊椎体的侧视图,显示了径向面及图10a中轨线角度的性质。
图10c是一个脊椎体的平面示意图,显示了横截面及图10a中轨线角度的性质。
图10d是一个脊椎体的后视图,显示了冠状面及图10a中轨线角度的性质。
图11是计算机根据图10a中数据汇总表定义的理想椎弓根螺钉置入生成的示意图表,并展示置入面的冠状面轨线。
图12展示了一个表格,该表格含有最大可利用螺钉尺寸参数,该参数数据与图10a中的数据汇总表的数据相对应,该表格还包括椎弓根基部圆周轮廓线(冠状面)和椎弓根点A到点B的距离。
图13是计算机生成的螺钉置入的示意图,该螺钉置入标示于图12的表格中。
图14a是一个脊椎体的侧视图,显示了峡部和椎弓根基部圆周。
图14b是一个脊椎体的平面示意图,显示了由计算机生成的、在横截面和冠状面延伸穿过椎弓根基部圆周的圆柱。
图14c、14d和14e分别是腰椎、胸椎和颈椎区域的脊椎体的平面图,显 示了每个脊椎体中峡部与椎弓根基部圆周的关系。
图14f和14g是一个脊椎体的后视示意图,显示了用于在脊椎体中产生椎弓根螺钉定位孔的锥子的定位状态。
图14h显示了一个脊椎体的互相对齐的平面以及后视示意图,并显示一个人工地确定的椎弓根螺钉方向线,该椎弓根螺钉方向线延伸穿过椎弓根基部圆周中心。
图15a、15c和15e显示了一个脊椎体在不同方位的后视示意图,并显示了计算机生成的椎弓根螺钉圆柱,该椎弓根螺钉圆柱延伸通过其椎弓根基部圆周。
图15b、15d和15f分别显示了图15a、15c和15e所示脊椎体的侧视示意图。
图16是通过椎弓根T1、T2、T4和T5中心的CT轴视图,显示了与每个脊椎体在手术中的前后位荧光透视成像结合后的椎弓根形态、峡部和椎弓根定位孔进入点的确定。
图17a和17b是本发明中可调整锥子的不同实施例的侧视图。
图18a是单节脊椎体和椎弓根基部圆周在手术中前后位荧光透视成像的示意图。
图18b是计算机生成的脊椎体的三维图像的示意图,并显示了由计算机置入的椎弓根圆柱和椎弓根基部圆周。
图18c是图18a和图18b的套准图象示意图。
图19a是本发明的双环椎弓根螺钉排列装置的侧视图。
图19b是图19a所示装置的主视图。
图19c和19d单节脊椎体的平面视图,分别显示了经皮环境和开放的外科 手术环境中双环椎弓根螺钉排列装置的使用。
图20是本发明的双环椎弓根螺钉排列装置另一实施例的主视图。
图21a和21b是分别本发明钻孔套管部分第一实施例的尾部的侧视图和主视图,该套管部分用于图19a和19b所示的双环椎弓根螺钉排列装置。
图22a和22b是本发明钻孔套管部分第二实施例的尾部的侧视图和前视图,该套管部分用于图19a和19b所示的双环椎弓根螺钉排列装置。
图23a是一个槽形外套管的立体图,该外套管与图19a和19b中双环椎弓根螺钉排列装置配套使用。
图23b是图23a所示的槽形外套管的主视图,双环椎弓根螺钉排列装置中的一个排列环置入其中。
图24是一个挖空的脊椎体的示意图,显示了不同的椎弓根螺钉轨线,其一具有中心的或理想的轨线,另一具有骨外或椎弓根外轨线,骨外或椎弓根外轨线偏离中心轨线。
图25是一个脊椎体的平面示意图,显示了依照本发明方法进行的椎弓根螺钉的安装。
图26a,图26b,图26c是脊椎体的侧视图,平面视图和后视图,显示了计算机产生的穿过椎弓根基部圆周和峡部而延伸的椎弓根圆柱体。
图27a、图27b和图27c是类似于图26a,图26b和图26c的示意图,显示的是计算机产生的对脊椎骨内有脊椎骨骨折或异常脊椎骨骨骼的偏轴置入的椎弓根圆柱体。
图28a、图28b和图28c是类似于图27a、图27b和图27c的示意图,显示的是计算机产生的对改进的脊椎骨内的偏轴置入的椎弓根圆柱体。
图29是脊椎骨和锥子/引导线的后视图,显示的是与本发明中的方法相一 致的待***的锥子和引导线。
图30是类似于图29的示意图,显示的是锥子/引导线的一部分被***到脊椎骨中。
图31是类似于图29和图30的示意图,显示的是锥子/引导线完全被***到脊椎骨中。
图32是类似于图31的示意图,显示的是钻头在引导线上进入脊椎骨中。
图33是类似于图31的示意图,显示的是第一个套管在引导线上进入脊椎骨中。
图34是类似于图33的示意图,显示的是第一个套管被送入脊椎骨中并且第二个套管被送入第一个套管中。
图35时类似于图34的示意图,显示的是第二个套管被送入第一个套管中。
图36是类似于图35的示意图,显示的是一个导管或类似设备通过第二个和/或第一个套管被送入脊椎骨中。
图37是类似于图36的示意图,显示的是球囊导管通过第二个和/或第一个套管被送入脊椎骨中。
图38a和图38b是平面示意图和后视图,显示的是定角导管通过第二个套管被部分送入脊椎骨中。
图39a和图39b是类似于图38a和图38b的示意图,显示的是定角导管通过第二个套管被完全地送入脊椎骨中。
最佳实施例
本发明中关于确定椎弓根螺钉尺寸和置入位置的方法将在下面详细描述。
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
图2中所示的单个脊椎骨三维图象被计算机挖空,类似于一次经椎弓根锥体次切除(eggshell transpedicular vertebral corpectomy),从而得到外科医生所需要的规格(也就是保留在脊椎体皮层或是椎弓根壁的厚度)。这些规格考虑到了不对称的厚度,举例来说,前脊椎体皮层约有五毫米厚,侧脊椎壁约七毫米厚,椎弓根壁仅一毫米厚;或脊椎部分皮层壁一概为五毫米厚且椎弓根壁仅一毫米厚。单个脊椎骨能被结构化显示,这个结构是被挖去只剩核心或是被挖空的,使得保留的脊椎体以一种合适的方式贯穿其壁被“通电”(electrified)或显亮(highlighted)。
步骤4
然后,计算机通过测量根据外科医生对椎弓根皮层壁的直径参数选择选定的椎弓根的最窄直径或横截区域(峡部)X,自动确定被置入螺钉的最大允许直径,如图3所示。
步骤5
然后计算机生成一个从峡部X中心开始沿如图4所示直线10伸长的圆柱,该圆柱确定了理想的轴/轨线,并向例如垂直于椎弓根峡部所在平面的两相反方向延伸,这样就能尽可能地将该圆柱集中设置在椎弓根内部而不接触到剩下 的皮层,在峡部中心形成支点。所述的直线可以刺穿背部或后椎弓根皮层,这样就能延伸到病人的皮肤外至任意所期望的长度。所述直线在锥体内部延伸至与预先确定的前内部皮层壁为预定的距离(例如5毫米)时停止,该距离由外科医生选择,这样它就不会刺穿前外部皮层并且还可以最大化螺钉直径,详后述。
步骤6
如图5所示,然后计算机以直线10为中心在半径方向上扩展至其最终的最大直径,使得最终最大直径不超过基于外科医生偏好椎弓根皮层壁厚度确定的最窄椎弓根直径。这个环状同心构造最终达到一个可见的圆柱体12,当它的外表面任何一点接触到内皮层壁的时候,圆柱体12停止构造。圆柱体内部中心形成的直线10会以一种比同心圆柱体12不同的颜色或方式标示出来。如在下文描述的,圆柱体12可能会伸展超过它与背/后皮层的交叉点以便于依照下文描述一种自动化方法进行的螺钉置入。
步骤7
被允许的最大直径实际上要小于方法确定的有些有着不规则椎弓根的最窄直径,如图6b所示,例如弯曲的椎弓根(图7b)或类似的畸形骨骼。这样可以预防皮质椎弓根壁的破裂。
步骤8
计算机然后通过测量圆柱体12的长度来确定螺钉的长度,圆柱体12从图8中邻近预定前内皮层的D点开始测量直到交叉点A。
步骤9
然后计算机产生一个数据汇总表,如图10a所示,该表显示了每个单节脊椎体椎弓根的理想椎弓根螺钉的直径、长度和轨线(如图10b和10c所示,以相应 的上端面20为参考面,轨线是通过测量横截面和矢状面相对参考面的角度而得),还提供了图11所示的理想示意图。参阅图9,经医生鉴定的特殊的脊椎体被加上标签,然后计算机用医生确认的精确脊椎体标签自动标记剩下的脊椎体。
步骤10
然后利用表格中的数据确定使用基于如图12所示的最大直径和长度的椎弓根螺钉的生存能力,所述数据同样被用来按外科医生的偏好方法确定螺钉的置入。图12还提供了单节椎弓根基部从点A到B的圆周轮廓线(冠状轨线)及它们各自的长度。实际使用的螺钉尺寸是基于外科医生选用的商业上可用的螺钉。一旦外科医生在所选椎弓根螺钉***内提供可用螺钉的尺寸范围,计算机就能自动确定并产生所述表格,同时产生一个理想化的前后位示意图(冠状)、带有图13所示数据的侧面和横截面图。此外,这个***还为外科医生提供一种基本能力,即根据单节脊椎体基部选择不同于最大可用直径的直径,并且将这些变化并入到数据汇总表和图中。
步骤11人工椎弓根螺钉置入
外科医生根据理想化的示意图和总结数据采用其偏好的方法来进行椎弓根螺钉置入。
步骤12a-椎弓根基部圆周轮廓法-人工确定
这种方法利用解剖学中意义重大的X光照相技术拍摄的脊椎体图像来匹配如图10d和11所示的冠状面理想的椎弓根螺钉轨线。特别地,在标准的X光照片或荧光透视成像所看到的放射线密度圆周线与椎弓根基部圆周相符。椎弓根基部圆周B被定义为椎弓根壁和它过渡到脊椎体的皮层接合点。所述椎弓根基部圆周显然不同于椎弓根峡部,但是对于单节脊椎体而言,在某些情况下它 们是同一个或非常接近,在图14a到14e中可以看到。
对于椎弓根基部圆周技术的人工利用,参阅图14b,首先利用相应的穿过椎弓根的横截面X光图像人工确定通过椎弓根峡部X的理想轨线。然后测量椎弓根峡部X,从而确定最大直径的椎弓根螺钉,轨线被用来确定椎弓根螺钉的最大长度。然后,如图14b所示,通过鉴别椎弓根壁到脊椎体的映射转换确定椎弓根基部圆周B。最后,测量A到B的长度,并利用该长度校准合适的工具,例如下文所述的长度可变的锥子,所述A到B的长度对应于后皮层A上的起点到与椎弓根基部圆周B的交点之间的长度。如图14h所示,点A和点B应该关于椎弓根基部圆周从椎弓根基部圆周的顶部(头部)和底部(尾部)边缘集中。然后结合理想轨线和椎弓根基部圆周确定点A关于椎弓根基部圆周前后方向上的位置和点B在椎弓根基部圆周内部的位置。所述椎弓根基部圆周轮廓线具有类似于每个单节脊椎体的前后位X光图像的圆形外形。
对于椎弓根螺钉的人工置入,可以利用标准荧光透视单元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,当具有头部脊椎体的脊椎体上端面用对称圆盘空间荧光透视形象化时,及当脊椎体通过椎弓根基部圆周轮廓在荧光透视前后位图像上可以明显识别其距每个椎弓根的距离相等时,脊椎体居中置入。当每个脊椎体有不同的两个椎弓根时,例如天生畸形、瘤、骨折等,该居中置入依然可以进行。然后在荧光透视成像下,将一经适当校准的长度可变的锥子或其它合适的工具T从椎弓根定位孔的起点A***相应的脊椎体的后皮层,并向椎弓根内推进至点B,参阅图14f和14g。这种置入在荧光透视下确定,并在与理想轨线对齐的直线上绘出A和B两点。工具T被重新调长,更进一步向脊椎体内部推进至点D或改用其它椎弓根探测锥或相似的工具。然后探测椎弓根内骨质的完整性,打开定位孔,具有适当直径和长度的椎 弓根螺钉置入到脊椎体。
根据步骤12a,穿过椎弓根T1、T2、T4、T5中心的CT轴视图,如图16所示,结合在手术中每个脊椎体的前后荧光透视成像,展示了椎弓根形态、峡部和椎弓根定位孔进入点的人工确定。椎弓根螺钉的长度、直径和轨线已经确定。椎弓根基部圆周轮廓线由右下角圆代表,并被用来作为识别椎弓根定位孔进入点的一致性手术标记。例如,椎弓根T1和T2的起点A分别是大约2个和1.25个椎弓根基部圆周,如在手术中的前后位荧光透视成像上所见(圆内部用圆点显示)。椎弓根T4和T5的定位孔分别是0.9和0.8个椎弓根基部圆周。步骤12b-椎弓根基部圆周轮廓法-半自动
这种方法类似于步骤12a,除了点A和B与椎弓根基部圆周轮廓是由计算机在构建了椎弓根圆柱后确定的。然后这些数据汇总进图12。所述数据还包括径向和横向轨线与上端面和中线的夹角度数。长度可变的锥子或其它工具,例如,可以适当调整到图12中的特定椎弓根距离A-B,并按照步骤12a中描述的方法在标准荧光透视图像下将螺钉置入。
步骤12c-椎弓根基部圆周轮廓法-全自动
这种方法进一步扩展了本技术,可以实时成像和多个脊椎体形象化,呈现椎弓根螺钉置入情况。产生的数据与图12中的一样,除了椎弓根基部圆周轮廓和标识点A和B是动态的,也不要求如步骤12a和12b中要求的脊椎体居中置入或上端面平行于荧光透视成像。荧光透视成像的脊椎体通过任何适当的方法登记在计算机上,形成带有相应的计算机生成的椎弓根圆柱的脊椎体。然后点A和B被显现出来,如图15a、15c和15e中所示,显示了按图12更新的实时图像。长度可变的锥子或其它工具,例如,可以调整到大约适合每个单个脊椎体从点A开始推进到点B的长度。注意,任意合适的工具,如不可调整的锥 子,可以按本发明方法不同于可调整的锥子使用。
步骤13-可调整的可变长度的锥子
点A到点B的距离(图14b),即后皮层到与椎弓根基部圆周的交点的距离,被用来设置可调整的长度可变的锥子的长度A到B,所述锥子用来在荧光透视成像下开设椎弓根定位孔。在椎弓根螺钉置入的一系列步骤中,形成该椎弓根定位孔是第一步,从计算机指出的识别起点A开始,一旦它完全固定,就产生椎弓根圆柱并将其推进到点B。
参阅图17a,锥子100包括一个用来***锥子本体的射线可穿透的外套102,其末端开口,用来移动地支持射线不可穿透的锥子本体104。所述锥子100完全可以调整到与A到B的长度一致的长度,也可以设置以防止锥子进一步推进超过图14b和其它图中可见的任何距离A到B。一旦A到B的距离在X光线成像中被确定,外科医生可以调整所述锥子点A到点D的任意长度,即图14b中最后的螺钉长度。这种锥子100最好具有能承受用槌棒或类似物敲打的结构,而其直径也足够窄用来穿透皮肤。为了便于显示深度,锥子本体104可以按固定的增量106用颜色或其它方式标记,如5毫米或10毫米。
锥子100外部末端具有用于敲打的坚固的头部108,还有合适的锁定装置110,如螺钉锁定装置,用来在相对于外套102的期望的位置锁定锥子本体104。所述锥子还有一个窗口112或其它标记,用来显示锥子本体104的位置或长度。图14f和14g显示了一个正在推进椎弓根内部开设螺钉定位孔的锥子。
图17b揭露了一个改进的可调整的锥子300,包括可插导管的或空的锥子本体304和一个具有中心孔309的头部308,这样一个导线311可以穿过头部和锥子本体304延伸至其内端。在定位孔用锥子300打通后,导线311可以留在定位孔中适当的位置,从而在后面的步骤中方便用它的位置为椎弓根螺钉的 置入导航。
步骤14-双环排列装置
对于在手术中自动置入椎弓根螺钉的方法,有用到具有真实尺寸的三维脊柱模型,该模型中具有计算机自动置入的椎弓根螺钉圆柱,所述圆柱定义了椎弓根螺钉的长度、直径和轨线。另外,还用到椎弓根基部圆周轮廓数据,以利手术中成像的记录。
手术中实时进行荧光透视检查,以准确记录单节脊椎体基部的三维模型。这种荧光透视的脊椎体成像被集中在监控器上,并由外科医生鉴别出特别的脊椎体(例如T2,T3等)。相应的具有真实尺寸的三维单节脊椎体模型与荧光透视图像套准,如图18a、18b和18c所示。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。
该套准是利用内部脊椎体骨性标记进行,这些标记是荧光透视成像中所见的椎弓根基部圆周,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,基于脊椎体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。
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,这种要求特别不利于经皮置入的应用。这种方法还允许一个脊椎体自由独立地向另一个脊椎体移动,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套准充分,以进行椎弓根螺钉的置入。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。
现在包括计算机生成的椎弓根基部圆周和椎弓根圆柱的完整的三维图像接着被投射到手术中的荧光透视成像上。如图19a和19b所示,计算机生成的椎弓根螺钉圆柱200穿过后皮层并凸出到病人体外,并被两个分离的同线环202、204截取及延伸穿过该同线环202、204。该环安装在一个配套的锚定在病床或其它支持物上(未显示)的支架206上,环的尺寸允许截取计算机圆柱图像和将锥子套管***。第一个环202在靠近后皮层区域208或刚好在体外截取计算机椎弓根螺钉圆柱,而第二个环204在距第一个环202任意期望的距离处截取计算机椎弓根螺钉圆柱。两个环之间的距离越大,螺钉的置入就越准确。环202、204对计算机椎弓根圆柱的截取在计算机监控器上显示,展示环相对计算机椎弓根圆柱200移动。
图19c和19d分别显示了经皮环境和开放的外科手术环境中从脊椎体VB伸出并穿过环202、204的计算机生成的圆柱200和直线210。
椎弓根圆柱的截取发生在两个层面上。计算机椎弓根圆柱200中心线210及其***圆柱组成,首先,环202、204需要被置于中心线210和椎弓根圆柱200中心。第二,环与脊椎体套准以便在计算机监控器上跟踪其移动,例如通过LED装置。第三,环的内部直径与计算机生成的椎弓根圆柱200的直径匹配。有多种具有不同直径的移动环可供外科医生期望的椎弓根螺钉***利用。第四,为了与计算机生成的椎弓根圆柱的直径相匹配,环被构造成可以以任意合适的方式改变其直径,如图20所示,环202由可移动连接的部分212制成,该可移动连接的部分212可以旋转来改变环的直径的。计算机椎弓根圆柱与环的套准是在计算机监控器上被鉴别和确定的。
所述同线环202、204现在形成了一个用来置入钻孔套管214的通道(图21a和21b),该钻孔套管也被固定在支架206上。在钻孔套管214内设有一个 坚固的套管元件216(图21a和图21b)或一个特别的内部套管元件218(图22a和22b),该特别的套管元件内具有多个窄小的可移动的纵向平行的金属杆220,其中心开口可以置入锥子。这些金属杆220可以让内部套管元件218平稳地置入在不平坦的表面上。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,特别的内部套管元件218允许这些金属杆缩回,从而荧光透视可以清楚的呈现椎弓根内部的钻孔过程。外科医生可以使用任一种方式。
然后椎弓根被钻孔至所期望的预先校准的深度,不会超过预定的椎弓根螺钉的长度。然后用椎弓根探测器探测椎弓根以确保骨质的完整性。
实际的螺钉置入中,一种特别的槽形外套管230(图23a和23b)被置于与同线环202、204同一条直线上。这种槽形外套管230也连接在支架206或其它锚定装置上。然后旋转所述环大约90度(未显示)并从槽形外套管230上收回。槽形外套管的可调整的内部直径足以容纳任意具有螺纹和变化的头部的椎弓根螺钉。适当的椎弓根螺钉(未显示)被放入承载它的螺丝起子,置入槽形外套管,然后置入各自的椎弓根。
对于改进的可调整的并列环,如图20所示,图23a中的槽形外套管230可以选择使用,环202、204可以留在一定的位置并被调整至一个完全开放的位置从而让螺丝起子可以***并通过。
步骤15
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椎弓根螺钉的置入提供基础,这如前文所述或根据医生的优先选择。
步骤16
有些外科医生宁愿从骨外或椎弓根外置入螺钉,那是因为椎弓根螺钉的尺寸太小,难以提供可以利用的螺钉尺寸,对于这些医生来说,计划用偏心螺钉置入大的椎弓根或计划用与剖面轴相对的直头螺钉置入,也可以用本发明的方法。本发明是这样实现:获取所有理想化的数据,然后由外科医生偏移椎弓根定位孔进入口,该偏移是从理想轨线的正切方向偏移任意期望的距离,也就是说,前螺钉位置在枢轴点D,计算机椎弓根圆柱12从该点产生,如图24所示。
此外,这些变化将被自动记载,并结合这些变化产生新的理想化的前后视图、侧视图和轴视图。不管是用椎弓根基部圆周方法,还是用自动排列方法,还是用商业上可用的CT/荧光透视套准法,都可以用这些数据进行螺钉的置入。对于椎弓根基部圆周方法,定位孔的长度被定为可以让合适长度的锥子或其它工具置入。
作为一个实施例,图25显示了用螺丝起子22或类似工具安装椎弓根螺钉20的示意图,椎弓根螺钉穿过峡部X中心。
步骤17
使用椎弓根峡作为直线延伸的支点来构造椎弓根圆柱体的新方法是这里描述的方法的延伸。主要的差别是新方法修改了前面描述的突入路,通过对有着病态或创伤特征且异常的脊椎骨骼有意继续计划的偏轴置入来实现。对没有端面骨折或压缩的正常脊椎部分,选择的同心轨线贯穿椎弓根来构建椎弓根圆柱体,如图26a、26b和26c所示。
步骤18
对于偏轴的椎弓根圆柱体构造,直线延伸的支点仍在脊椎骨最窄的那一部分,即椎弓根峡X。然而,一旦确定了峡,下一步就是确定脊椎骨内的D点的 位置。D点到上下端面等距,在脊椎骨中部,邻接前内皮层壁。计算机描绘一条从D点到椎弓根峡中部的直线,该直线穿出后椎弓根皮层。图27a至图2c以及图28a至图28c表示了脊椎骨轨线的确定,所述脊椎骨有各自相同的上端面和下端面压缩骨折。图25a-c,27a-c和28a-c表示了有起始点A和B位置的径向面和横向面。冠状图表示了横向面和径向面的结合效果,以便正确标识图12中所示的起始点A和B。
步骤19
计算机在径向方向构建一个同心圆柱体,直到这个同心圆柱体接触到显亮皮层。计算机然后确定理想椎弓根轨线、直径和长度并将他们记录在表中(图12所示)。椎弓根基部圆周识别点A和点B,使得结合放射不透光/放射可透光的色带锥子/引导线能准确置入椎弓根内,并能前进适当的深度距离,如图12中标记的A-B点。
步骤20
放射不透光带/放射透光带和色带锥子/色带引导线,例如图17b中的300/311,被置入在A点,如图29所示,其被送到B点,如图30所示。这个表示了通过测量荧光图像下看到的单位长度得到的穿透量。一旦A点和B点被正确标识出,锥子/引导线带300/311就要被送至D点(图31所示)。
步骤21
有放射不透光带/放射透光带和色带的钻头400***第一个套管,并被送到引导线311处并继续钻深至D点。这个在荧光图象下显示出来如图32所示。
步骤22
在一个实施例中,第一个套管500在引导线311上进入椎弓根,直至其与前皮层平齐。套管500有一个射线可透的中部502,一个放射不透光颈圈504 和一个放射不透光内环506,所述的颈圈504紧靠前皮层,所述的内环506对应于基于合适长度测量的B点。将其安全地下压至后椎弓根皮层表面,如图33所示。引导线311然后被移出,一个合适的工具,例如导管、套管或针从第一个套管中***到椎弓根内部来进行所需动作。
步骤23
在第二个实施例中,第二个复合套管600被送入到第一个椎弓根套管500中。第二个套管600包含一个长度匹配且射线可透的内部中心或圆柱体602以对应到椎弓根套管500,该圆柱体602有一个放射不透光圆环604在其端部。第二个套管同时还有一个外部带狭槽的套管部分606,该狭槽套管606延伸直至超过经皮应用的皮肤。此外,第二个套管还有一个与第一个套管500相配的连锁机制(图中没有显示),其便于置入和移动第一个套管,如图35所示。所述的连锁机制为咬和机制、钉和机制或是其它类似的机制。
然后有带引导线311被移出,被锁的第一个套管500和第二个特制带狭槽套管600作为一个工作组合,为椎体后凸成形术、椎体形成术或脊椎组织检查工具打开入口,如图35所示。当进行椎弓根螺钉置入时,外科医生能根据这里描述的方法选择螺钉置入的方式。
步骤24
在第三个实施例中,第一个套管500被省略,第二个套管600在引导线311上直接被送入钻头400钻出的开口。然后引导线311被移出,一个合适的工具通过第二个套管600被送入椎弓根内部进行所需操作,如图36-39所示的方式。
步骤25
然后继续采用传统的方法进行所期望的经关节手术。对现有设备的一个改进是改进了的荧光图像下的放射不透光/射线透光和色带锥体后凸成形术球囊 导管、椎体形成术导管或脊椎骨组织检查针700,如图36所示。
步骤26
在椎体后凸成形术过程中,球囊导管702被直接引入且不倾向第一个套管500或狭槽套管600,如图37中所示。所述导管702被送入合适深度并膨胀,以产生合适的压力。接合剂或其它合适的注入材料被送入球囊导管产生的空腔。
步骤27
对现有球囊导管或类似设备的改进并不仅是条带,还包括提供了定角球囊或设备704,如图38a-b和39a-b所示。狭槽套管600允许定角球囊导管704的引入和前送,使得根据椎弓根长度A-B,该定角球囊导管704被送至一个预弯的长度或被人工弯至一个所需的角度。一旦所述导管704完全邻接后椎弓根皮层,它将被进一步送入脊椎骨内,同时相对套管600横向面抬起并传递压力。荧光图像如图39a和39b所示。新改进的方法考虑到脊椎骨内的导管704更集中的置入。当导管704被完全地送入脊椎体中,狭槽套管606便接接触到导管704的外部。这个比双面经关节突入路有更实质的优势,例如减少手术时间,减少荧光图像数,更好的将椎弓根螺钉设备结合到破裂骨折中,理论上在脊椎骨中仅用一种射线即可代表可视的椎弓根,及在小的脊椎骨中应用。
所述的本发明的方法的许多步骤都是计算机产生的,值得注意的是,任何合适的设备或装置都可以用来实现本发明方法的这些步骤。
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 (2)
1.一种套管,用于***到椎弓根中的伸长开口里,该开口从椎弓根内后皮层延伸到所述椎弓根内的预定深度,所述套管包含一个伸长的空心圆柱体,该空心圆柱体被构建用于被***所述开口内,所述套管还包含一个伸长的套管部分,该套管部分相对于空心圆柱体放大并且从所述空心圆柱体纵向向外延伸,所述套管部分还含有一个纵向延伸的狭槽,使得通过所述套管塞入椎弓根的直的或定角设备起期望的作用。
2.如权利要求1所述的套管,其特征在于:所述空心圆柱体有一定长度,该长度与椎弓根开口的长度相似,及在荧光图像下,所述空心圆柱体是射线可透的,在外端和内端有射线不透的圆环。
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CA2816973C (en) | 2014-11-04 |
US20090005790A1 (en) | 2009-01-01 |
ES2784219T3 (es) | 2020-09-23 |
WO2006096702A8 (en) | 2008-03-20 |
JP2012148086A (ja) | 2012-08-09 |
JP4976370B2 (ja) | 2012-07-18 |
AU2010219346A1 (en) | 2010-09-30 |
EP1861010B1 (en) | 2019-12-25 |
CA2600387C (en) | 2013-12-10 |
AU2010219346B2 (en) | 2012-03-15 |
US20060235338A1 (en) | 2006-10-19 |
EP1861010A4 (en) | 2011-01-26 |
WO2006096702A2 (en) | 2006-09-14 |
CN101528122A (zh) | 2009-09-09 |
HK1133564A1 (en) | 2010-04-01 |
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