CN100493462C - Mri活组织检查装置 - Google Patents

Mri活组织检查装置 Download PDF

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CN100493462C
CN100493462C CNB2005100746361A CN200510074636A CN100493462C CN 100493462 C CN100493462 C CN 100493462C CN B2005100746361 A CNB2005100746361 A CN B2005100746361A CN 200510074636 A CN200510074636 A CN 200510074636A CN 100493462 C CN100493462 C CN 100493462C
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biopsy
fixture
guide rail
mri
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CN1706349A (zh
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罗伯特·休斯
蒂莫西·G·迪茨
迈克尔·安德雷科
比尔·克莱姆
马丁·B·阿尔宾尼
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Devicor Medical Products Inc
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Ethicon Endo Surgery Inc
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Abstract

一种定位机构或者夹具，其在开放和闭合磁共振成像(MRI)机中的趋向活组织检查过程中与乳房线圈结合用于对乳房施压和导引针芯活组织检查仪器。该定位夹具包括一个可三维Cartesian定位的导向件，用于将MRI相容活组织检查装置，特别是套管支撑和定向于可疑组织或病变的活组织检查位点。限深器增加了插入精确性，防止了套管过插或者无意的回缩。套管接收MRI相容活组织检查仪器的探头，并可包括各种部件以增强其可成像性，增强真空及压力辅助，等等。

Description

MRI活组织检查装置
相关申请的交叉引用
本申请要求名称为“磁共振成像活组织检查装置”的美国临时申请的优先权，该美国临时申请由Hughes等人于2004年5月21日申请，系列号为60/573,510，并且本申请还涉及名称为“用于MRI可活组织检查装置的定位机构”的正式专利申请，其由Hibner等人于2002年4月23日申请，系列号为10/171,330并于2003年10月23日公开，公开号为US 2003/0199785，二者的内容全部引入作为参考
发明领域
本发明总的涉及一种辅助组织取样的成像方法，更具体地说，涉及一种为了获得皮下活组织检查和为了去除病变而将活组织检查探头相对于磁共振成像(MRI)乳房线圈定位的改进方法。
背景技术
最近，针芯活组织检查装置已经与成像技术结合以更好的对准乳腺组织中的病变。一种这样的可在市场上购买到的产品由EthiconEndo-Surgery公司以为MAMMOTOMETM的商标名称在市场上销售。在于1996年6月18日授权给Burbank等人的美国专利No.5,526,822中描述了该装置的一个实施例，其在此被作为参考引用。它的手柄接收机械和电子能量以及来自与磁共振成像(MRI)机的高磁场隔开的远程位置控制模块的真空辅助。
如该参考文献所述，该仪器是一种图像引导式经皮针吸乳腺活组织检查仪器。该仪器是真空辅助的，并自动完成用于恢复组织样本的一些步骤。在将其从体内切除之前，医生使用这个装置收集(使用真空)“活”组织。这允许采集变化硬度的组织的样本。另外，使用侧开口孔，避免了必须插入病变，而这种插入病变会趋向于将肿块推开，引起轨迹转移灶，或者引起血肿，该血肿与在其中循环的剩余造影剂一起可能导致与可疑病变极为相似。侧孔可以围绕探头的纵向轴线旋转，从而允许采集多个组织样本而不用重新定位探头。这些特征允许对大病变多份采样并完全去除小病变。
在前述的Hibner等人的公开号为US 2003/0199785的专利申请中，所述的定位夹具可与乳房线圈连接。这些定位夹具辅助将探头准确定位于乳腺组织的可疑病变的位置。特别地，可疑病变的X-Y-Z笛卡尔坐标参照定位夹具中的基准标记。当患者从闭孔的MRI装置中退出后，人肉眼可见的每一根轴的检测导向件允许探头相应地定位，而无需在插入过程中使探头成像。此外，定位夹具使得能够在MRI活组织检查装置中采用可拆卸的探头。因此，在后续的探头再成像过程中，如在闭孔的MRI装置壁和边界的范围内所需要的那样，MRI活组织检查装置的手柄可拆卸。当手柄与探头连接时，可采用描述的定位夹具的各种支撑结构沿长度方向来支撑手柄。
虽然与可拆卸的MRI活组织检查探头一起使用的定位夹具有许多优点，仍需要采用附加的部件，以进一步辅助在探针的精确定位、防止过度插入或者无意的探头回缩，以及支撑MRI活组织检查装置。
因此，迫切需要提供一种改进的用于MRI导向的活组织检查过程中的定位夹具，该夹具可辅助定位可疑病变，并精确进行活组织检查，或者完全切除该可疑病变，甚至与闭孔MRI装置的闭合边界连接。
发明内容
本发明通过提供一种定位及导向组件，从而克服了现有技术的上述不足及其它缺点，该定位及导向组件将MRI活组织检查装置与乳房线圈连接以精确定位，并将探头保持在患者乳房的预定位置处，来进行活组织检查及相关的诊断和治疗步骤，尤其是进行单次插入并取得多个活组织检查样本。
在本发明的一个方面中，一个导向元件可选择地与穿刺进入患者的预期轴线平行定位。一个固定件与导向元件可移动地接合，从而在插入患者的过程中，可沿着穿刺轴线支撑活组织检查仪器的穿刺部分。可选择地与固定件和导向元件二者之一连接的深度限制构件在完全插入前可有利地进行调节，以使在穿刺部分到达预期深度时阻止固定件的末端运动。
在本发明的另一个方面中，当使一个基座横向定位以支撑导向元件，且该导向元件也可在基座上垂直调节成与预期的穿刺轴线平行排列时，定位夹具压缩地定位患者乳房。因此，在乳房活组织检查过程中实现了精确插入和更好的免持定位。
在本发明的又一个方面中，一种导向活组织检查装置的穿刺部分的方法包括，将导向元件与穿刺进入患者的标记轴线平行对准以及偏置。在组织穿刺之前设定一个穿刺深度限制，以确保避免对待测目标的过射。然后，活组织检查装置的穿刺部分与导向元件的滑动接合沿着穿刺标记轴线对患者进行穿刺，直到其被深度限制装置制动。
通过附图和说明书，本发明的内容将更加清楚。
附图简述
附图包含于说明书中并构成其一部分，与前面给出的本发明的一般描述及下面给出的实施方式的详细描述一道，用于解释本发明的原理。
图1是磁共振成像(MRI)活组织检查系统与元件形式的导向设备的分解透视图，该导向设备具有一个用于探头限深器定位及活组织检查装置导向的单个靶标导轨；
图2是图1中MRI活组织检查系统元件形式的定位夹具和限深器以及MRI活组织检查装置的分解透视图；
图3是限深器和MRI活组织检查装置定位后，图1的MRI活组织检查系统元件形式的定位基座和单个靶标导轨的透视图；
图4是用于图1的MRI活组织检查系统的一种可供选择的导向组件的分解透视图，装有垂直瞄准及活组织检查支撑导轨(“支架”)；
图5是支架与用于图1的MRI活组织检查系统的另一种可供选择的导向组件接合的限深器第二导轨(图示为锁定)的透视图；
图5A是图示为锁定的图5中的限深器第二导轨的透视图；
图5B是沿图5中的线5B-5B的横截面截取的支架与限深器第二导轨的近端剖视图；
图5C是对准图5中限深器第二导轨以插入到支架中、用于插入套管的俯视图；
图5D是将图5C中的限深器第二导轨插入支架后的俯视图；
图6是一种用于图1的MRI活组织检查系统的可供选择的深度导向组件的俯视图，其具有一个可翻转(flip)单片眼镜及一个解锁套管锁470的侧杆；
图7是用于图1的MRI活组织检查系统的附加深度导向组件的顶部右侧透视图，其具有一个可进行粗调的关节；
图8是图7中深度导向组件的以虚线示出的调节关节和具有导向翼片的套管锁以及限深器第二导轨(螺纹)的左侧近端透视图；
图9是图7的深度导向组件的顶部左侧远端透视图；
图10是图7的深度导向组件的顶部近端端透视图，向远端调节以用于附加的深度；
图10A是图10的深度导向组件沿纵向横截面的俯视图；
图11另一种用于图1的MRI活组织检查系统的深度导向组件的顶部近端右侧视图，其具有一个粗调及释放按钮，显示为与第一靶标导轨分开；
图11A是图11的完全插入单个靶标导轨的具有粗调及释放按钮的深度导向组件沿纵向横截面的俯视图；
图11B是沿着图11的深度导向组件的线11A-11A截取的套管锁的左侧近端透视图；
图12是图11的深度导向组件部分地插入第一靶标导轨后的顶部近端右侧透视图；
图13是图11的深度导向组件完全地插入第一靶标导轨后的顶部近端右侧透视图；
图13A是图13的深度导向组件沿着线13A-13A的横截面截取的俯视图；
图14是伸缩式深度导向组件的顶部近端右侧透视图，其具有用于图1的MRI活组织检查系统与套管锁接合的套管及闭塞器；
图14A是固定于图1的MRI活组织检查系统的靶标导轨中的图14的伸缩式深度导向组件的俯视图；
图15是从靶标导轨及支架上拆分下来的图14的伸缩式深度导向组件的顶部近端右侧透视图；
图15A是图15的伸缩式深度导向组件的俯视图；
图16是当套管穿过支架上的一个单片眼镜时由靶标导轨引导的图14的伸缩式深度导向组件的顶部近端右侧透视图；
图16A是图16的伸缩式深度导向组件的俯视图；
图17是到达第一靶标深度后，图16的伸缩式深度导向组件的顶部近端右侧透视图；
图17A是图17的伸缩式深度导向组件的俯视图；
图18是将限深器第二导轨拧下后，图17的伸缩式深度导向组件的顶部近端右侧透视图；
图19是从远端插入调整的深度后，图18的伸缩式深度导向组件的顶部近端右侧透视图；
图20是压下近端锁定解除件并且将深度导向组件从靶标导轨及支架上部分回缩后，图19的伸缩式深度导向组件的顶部近端右侧透视图；
图21是一种用于图1的MRI活组织检查系统的可供选择的第一靶标导轨的顶部近端右侧透视图，其具有一个爪槽；
图22是一种可供选择的的中间伸缩式导轨的透视图，其锁定爪位于第二位置；
图23是图22的可供选择的中间伸缩式导轨的透视图，其与图21的第一靶标导轨相连，其锁定爪位于第三位置；
图23A是图22的可供选择的中间伸缩式导轨的透视图，其锁定爪位于第三位置；
图24是图23的中间伸缩式导轨的近端部分的右侧剖视图；
图24A是图24的中间伸缩式导轨的近端部分通过锁定爪、第一靶标导轨的爪槽以及中间伸缩式导轨的锁定爪口的剖面的俯视图；
图25是用于图22的可供选择的中间伸缩导轨和具有锁定齿的套管锁的透视图；
图26是图23的第一靶标导轨及中间伸缩导轨的后侧剖图；
图27是中间伸缩导轨的近端部分的左侧剖视图；
图28是一种用于图1的MRI活组织检查系统的侧向导向活组织检查盒的透视图；
图28A是分解的图28的侧向导向活组织检查盒的左侧剖视图；
图28B是图28的侧向活组织检查导向盒沿着纵向中心线截取的左侧剖视图；
图28C是图28的侧向导向活组织检查盒沿着纵向中心线的俯视图；
图29A是图28的侧向导向活组织检查盒的初始状态的透视图，在该状态滑动套管回缩于穿刺器手柄中；
图29B是使滑动套管从穿刺器手柄中伸出后的图29A的侧向导向活组织检查盒的透视图；
图29C是图29B的横向导向活组织检查盒在压下释放按钮后，使套管及闭塞器从穿刺器管伸出但仍限定于滑动套管内的透视图；
图29D是当滑动套管和闭塞器与定位夹具的靶标导轨接合时，图29C的侧向必向活组织检查盒的透视图；
图29E是从滑动套管上解除锁定的穿刺器管的透视图；
图29F是进入滑动套管后的穿刺器管的透视图，其导致套管和闭塞器穿刺，进而允许滑动套管从靶标导轨上回缩；
图30A是一种可供选择的活组织检查盒的透视图，其包括带有图11的粗调及释放按钮的深度导向组件，并且套管固定于深度导向组件上，并且闭塞器缩进该可选择的活组织检查盒的穿刺器管内；
图30B是当滑动控制器前进到穿刺器管上，从而将闭塞器插入到套管中后的图30A的可供选择的活组织检查盒的透视图；
图30C是与固定夹具的靶标导轨及盒接合的该可供选择的活组织检查盒的透视图；
图30D是与固定夹具的靶标导轨及盒完全接合的该可供选择的活组织检查盒的透视图；以及
图30E是将该可供选择的活组织检查盒从固定夹具的靶标导轨及盒上移去，而将深度导向组件留在上面的透视图。
发明详述
现参看附图，其中相同的数字在几个示图中均表示相同的构件，在图1中，磁共振成像(MRI)活组织检查系统10包括一个导向元件和一个可调节的限深器，该限深器能帮助外科医生沿着预定导轨插入活组织检查探头而不会过射。特别地，导向元件可调整为与穿刺轴线平行地定位，该穿刺的目的在于通过插入点到达患者体内的手术位置，通常为已成像的可疑病变。在活组织检查装置从导向元件上分离的条件下，将限深器调节设定为预期的穿刺深度。然后，在对患者的组织进行穿刺直至限深器阻止固定件相对于导向元件进一步移动的过程中，至少支撑活组织检查装置的穿刺部分的固定件由导向元件引导。从而实现穿刺部分的精确插入，而不会插过头。
MRI活组织检查系统10包括控制模块12，该控制模块典型地位于容纳MRI机(未示出)的防护室的外部或至少被隔开，以减轻与它的强磁场和/或灵敏的射频(RF)信号检测天线的有害的相互作用。控制模块12控制并给MRI活组织检查装置14提供动力，该装置14可以紧靠MRI机的方式配合使用。MRI活组织检查装置14的一个例子是前述的MAMMOTOMETM仪器。MRI活组织检查装置14由被连接到乳房线圈18上的定位夹具16精确定位，而该线圈又支撑着病人(未示出)。可在市场上购买到的乳房线圈18的例子包括由WaukeshaWI的MRI DEVICE CORPORATION制造的BIOPSY BREAST COILMODEL BBC。导向组件20、特别是套管22被有利地连接到定位夹具16上以在处置的具体部分中与MRI活组织检查装置14的选择性使用相结合地增加成像和治疗的灵活性和准确性。导向组件20可包括一个或多个闭塞器24，其中的一个是这样的，即它在插入时并且在MRI活组织检查装置14未被插入其中的程序的后续部分中密封套管22。设置与定位夹具16一起使用的限深器26，以有利地防止套管22的过度插入、套管22的无意收回和/或提高将套管22沿Z轴安置到所需位置的准确性。
为了方便起见，在这里使用一个惯常作法来通过笛卡儿坐标在参照定位夹具16的乳腺组织内定位可疑的病变，并且其后将仪器(例如套管22)定位到这个位置，而不需要连续地成像该区域。如将在下面更详细描述的，沿乳房的外侧受压缩的多孔屏障相对于病人胸部的中间平面定义了X-Y平面，而且X轴相对于站立的病人是垂直的(径向的)，并且从面向定位夹具16的外露部分的医生的角度看相当于从左到右的轴线。相对于贴近病人皮肤的定位夹具16连接或定位的基准标记(未示出)定义了该平面的原点。垂直于该X-Y平面并向乳房的中间侧延伸的是Z轴，虽然应当理解可以允许相对该Z轴的插入角度有一定的变化，该轴典型地对应于MRI活组织检查装置14插入的取向和深度。这样，为了清楚起见，术语“Z轴”可以与“穿刺轴线”互相替换地使用，尽管后者可以或不可以垂直于用于在病人身上定位插入点的空间坐标。
将支撑安装限制器/限深器的追踪轨道与支撑活组织检查装置的重量的活组织检查轨道分离可有利地减少各组件之间的相互干扰，允许实现其中可以有选择地安装和除去某些构件且不会干扰其它构件的操作步骤。
在使用中，通过将电缆管理卷筒30放置在从控制模块12的一侧突出的电缆管理连接鞍座32上而制备MRI活组织检查系统10以便使用。缠在电缆管理卷筒30上的成对的电气电缆34和机械电缆36用于分别传递控制信号和刀具旋转/前进动作。具体地，电气和机械电缆34，36各具有连接在位于控制模块12中的相应电气和机械端口40，42上的一端和连接到安放MRI活组织检查装置14的机架44上的另一端。可以在不使用时保持机架44的MRI对接杯座46通过对接工位安装托架48被钩到控制模块12上。
安装到墙上的界面锁定盒50将系绳52设在控制模块12上的锁定端口54上。使系绳52有利地、独特地终止，并不够长以避免疏忽地将控制模块12过份靠近MRI机地设置。直插式外罩56可以有利地将系绳52，电气电缆34和机械电缆36对准在控制模块12上的它们各自的端口52，42，44。遥控键盘58可以在远侧被连接到电气电缆34上，以提高医生对MRI活组织检查装置14的控制，特别是当在将MRI活组织检查装置插入到定位夹具16中后不容易进行对MRI活组织检查装置14自身的控制时。
通过第一真空管线60提供真空辅助，该第一真空管线连接在控制模块12和捕捉液体及固体碎片的真空罐64的出口62之间。管道组件66完成控制模块12和MRI活组织检查装置14之间的气体连通。特别是，将第二真空管线68连接到真空罐64的入口70上。第二真空管线68分成被连接到MRI活组织检查装置14上的两个真空管线72，74。利用安装在机架44中的MRI活组织检查装置14，控制模块12进行功能检查。将盐水手工注入活组织检查装置14中以用作润滑剂并有助于实现真空密封。控制模块12致动在MRI活组织检查装置14中的刀具机构(未示出)，监控全部行程。
也将MRI活组织检查系统10的靠近MRI机使用的部分组装起来。将通常已知的乳房线圈18连同其它的身体支撑垫(未示出)一起放置在MRI机的台架上。被连接在位于乳房线圈18的每一横向侧上的凹陷部内以接近在其中悬垂地暴露的病人乳房的定位夹具16包括水平的中间板80，可重复使用的基底组件82，侧面组件84和定位基座86。定位夹具16还装配有一次性的中间栅90和侧窗(或多孔板)92。
基底组件82放置在乳房线圈18的选择的侧面凹陷部内。中间栅90被连接到中间板80的中间边缘上，在接收病人乳房的选择的乳房孔94的内边缘下大致沿乳房线圈18的纵向轴线垂直地对准。在病人如此定位并且将乳房的外部区域消毒的情况下，使侧窗92向下滑入侧面组件84的三边框架式导向件96中，该导向件96又放置在中间板80上。基底组件82和侧面组件84沿Z轴彼此相对地移动，以将病人的乳房压在中间栅90和侧窗92之间。在侧面组件84，基底组件82和中间板80之间形成的机构保持了这种压缩。
可以将造影剂注射到病人体内以增强成像。使台架前进到MRI机孔中以成像定位夹具16和乳腺组织。将侧窗92上的基准标记定位并指定为X-Y-Z坐标系的原点。然后，将可疑病变定位在图像内，并且选择其上的一个点以确定其相对于原点的位置。应当理解，通过具有用可成像材料形成的侧窗92，可以便于定向初始扫描的X-Y-Z轴，由此提供除基准标记的原点之外的X-Y平面。在确定了目标位置的情况下，从MRI机器孔收回台架。
定位基座86沿侧面组件84的X轴可滑动地被接合，并限定了用于在选择的Y轴坐标上定位单个靶标导轨(“轨道”)98的垂直导向件。轨道98又沿着用于在所需的Z轴坐标上定位限深器26和机架44的Z轴设置深度导向件。限深器被锁紧在轨道98上。其后，可以使标记仪(未示出)穿过限深器26，以在乳房上标记插入点。此后，将限深器26移开。在浅注射麻醉剂之后，在标记的位置处划开一切口，并随后将麻醉剂更深地注入划开的切口中。然后，将限深器26在轨道98上重新定位至所需的Z轴坐标参考。
将闭塞器24插入套管22并可以定位成封闭套管22的任何孔(侧面和/或末端)，从而给乳腺组织提供封闭的表面。也可以如此地成形或构成闭塞器以提高孔位置的可见性。闭塞器24和套管22之一会提供一锋利的尖端(未示出)以穿刺乳腺组织。例如，如果使用具有开口端的套管22，则闭塞器可以设置锋利的尖端。
将闭塞器24插入到套管22中，并且由轨道98将组合体引导到适当的取向，直到到达由限深器26设定的准确的深度。一旦完全插入，限深器26就防止过度插入。套管22有利地锁住轨道98和/或限深器26以防止无意中造成的收回，例如当收回闭塞器24并且从乳腺组织接收压力时，或更后面的当将MRI活组织检查装置14的探头100从套管22收回时。
将台架移入MRI机孔中并且对病人重新成像以确定套管22相对于可疑病变的放置。有利地是，套管22和/或闭塞器24的可成像材料，或许包含或包括标记材料，提高了在为随后的活组织检查样本定位时确定套管22和其套管侧孔102的位置的能力。
通过缩回台架而将病人从MRI机中移出，并且将有机架的MRI活组织检查装置14带到定位夹具16。从MRI活组织检查装置14的探头100上去除保护帽(未示出)，并且从套管22取出闭塞器24。图2和3中示出了将机架44安装到轨道98上，其中机架44和MRI活组织检查装置14结合在一起地在轨道98上滑动，而该轨道98已经相对于基座86和侧面组件84被定位在一确定位置。套管22和探头100的构件可以有利于从视觉上且以机械方式相对套管侧孔102定向探头100的探头侧孔104，以及形成气体密封。有利地是，机架44和/或探头100可以锁定在轨道98和套管22上，以确定完全插入并避免过度插入及无意中发生缩回。机架44允许希望手握使用的MRI活组织检查装置14在它与定位夹具16的连接中有足够的支撑，以准确地保持它的位置并且避免或最小化由探头100带来的负载。
其后，MRI活组织检查系统10可以通过在真空辅助下致动刀具机构、收回该刀具并取出组织样本来采集组织样本，取出组织样本的步骤或许也可以在真空辅助下进行。探头100/套管22的组合体能够为了另外的样本手动、或许自动地转动相对于它们的纵向轴线的所需角度，或者可以在目前的取向上通过进一步采取真空辅助来采集另外的样本。然后，使刀具前进以关闭探头侧孔104，并且将机架44从定位夹具16退回，从而将探头100从套管22取出。
在这点上可以进行额外的步骤或步骤的组合，例如使用探头100、专门的闭塞器24(例如，细探针)或仅仅是套管22来将各种药剂引导到活组织检查的手术部位。这些例子包括排液，引入麻醉剂，引入止血剂，随气压吹入和引入用于随后定位活组织检查部位的标记，或其它诊断或治疗过程。
然后，为了重新成像而通常将病人拉回到MRI机孔中，以确定至少一部分可疑病变的去除和标记的可能位置。在这个重新成像期间，用闭塞器或细探针24密封套管22。其后，移开定位夹具16，将病人用绷带包扎且从台架上移开，并且将MRI活组织检查系统10的一次性使用部分作为医疗废物进行处理。
装有用于限深器和活组织检查装置的单个靶标导轨的导向组件的元件形式
特别参考附图2-3，单个靶标导轨98便于分离组件的顺序安装。首先，安装限深器26，然后是套管22(如图1所示)，接着使活组织检查工具14滑上单个靶标导轨98。作为替换方式，如图2-3所示，单个靶标导轨98可以接收限深器26，然后使用MRI活组织检查装置14而不用分离的套管22。穿刺到病人乳房中的最大深度通过限深器26在单个靶标导轨98上的位置而预先设定。在机架44和单个靶标导轨98之间的接合机构(未示出)和/或由被表现为向上伸出的销110且在限深器26的上部轨道夹紧臂112上的掣子和卡扣在向上伸出的销110上的由弹簧向下偏压的摇杆插口(rocker latch)114形成的接合机构防止MRI活组织检查装置14的无意缩回。机架44可以通过在摇杆插口114的近侧致动臂116上的向下压力而脱离。
单个靶标导轨98可以将纵向尺寸设定成在近侧有效地延伸，从而在探头100接触病人的皮肤之前，MRI活组织检查装置14接合单个靶标导轨98。还将单个靶标导轨98的尺寸设定成不会在近侧延伸到其不能用于闭孔MRI机(未示出)的程度。相信该MRI相容活组织检查系统10将程序运转时间最小化到小于上述的45分钟。然而，尽管迅速完成运转，放射科医生可以将探头100准确定位到病变中心的2mm(最大5mm)内。另外，在对病人最小限度地重新定位的过程(桌子的两侧)中，放射科医生可以最大限度地接近两个乳房(左或右)。此外，穿刺组织需要最小量的力，例如小于4lbs。虽然限深器26用于防止超射，但在进一步插入探头100之前用于将限深器26重新定位的构件允许医生在瞄准另一位置方面具有灵活性。
垂直对准和活组织检查导轨(“支架”)
在图4中，用于MRI相容活组织检查系统10的一种可替换的导向组件200包括有连接到靶标导轨204上的支架202，并且设有用于支撑MRI活组织检查装置的活组织检查导轨206，两个导轨204，206对准Z轴。将靶标导轨204连接到定位支柱86(图4中未示出)上并垂直地调整到所需的Y位置。圆形安装点208可以形成与定位基座86的旋转接合以允许倾斜的瞄准导向。
靶标导轨204的侧面210包括上凸缘212和下凸缘214，它们各具有用于滑动地接收套管固定件216的L形横截面。在每个凸缘212，214上的多个竖排的侧向突出的凸脊218用作用于套管固定件216的锁定表面。在凸缘212，214之间，使侧通道220在其中凹陷。套管固定件216通过使它的套管毂224在近侧被接收在套管固定件216的毂接收器225中来引导套管222并在远侧由限深器226定位和限制。
限深器226包括接合侧通道220的滑动件228。限深器壳体230与该构件连接，终止于标线片232。锁定杆234被垂直地钉在远侧开口的凹陷部(未示出)内，在限深器226中形成由弹簧从那里偏压离开的侧面部分236，从而在远侧突出的支脚238相对凸脊218枢转并接合该凸脊218，特别是相对近侧移动地枢转。将侧面部分236靠着限深器壳体230的远侧开口的凹陷部向近侧压下的操作释放了在远侧突出的支脚238，以允许在远侧重新定位限深器226。
使活组织检查装置10的穿刺轴线与通过靶标导轨204和活组织检查导轨206限定的轴线对准，上述两个导轨分别从那里沿横向和纵向垂直地偏移。从靶标导轨204延伸的水平平面和从活组织检查导轨206延伸的垂直平面在为穿刺轴线的共同中心线处相交。具有垂直地对准并平行于穿刺轴线的活组织检查导轨206有利地用否则会产生插入的远端的偏移的最小扭转负载为活组织检查装置14的重量提供支撑。从而，即使对于相对较重和细长的装置，也可以在所需插入点的5mm、甚至2mm内实现其远端的定位和保持。由此，可以进行“免手持”过程，可用在穿刺轴线上方垂直位移的方案替换在所显示的变型中避免穿刺的不方便或不实用性的方案。特别是，具有可以与靶标导轨204的任一侧接合的支架可以进一步提供垂直对称并允许操作者充分利用通过乳房线圈18提供的空间。
虽然“免手持”能力对于单独插入式/多样本式活组织检查装置是有利的，但应当理解，带有在此所描述的预设的限深器的这种穿刺导向已经应用于甚至轻型活组织检查装置，该装置在每单个样本单独插入时使用针芯活组织检查。特别是，不需要在连续成像时修正放置。当免手操控的时候，避免了插入时的过度穿刺和无意的移动。
在靶标导轨204中的底部楔形通道240接收在支架202上的顶部楔形延长部242，而且该延长部在其中滑动。应当理解，当从近侧看时在这里示出了关于定位基座86的左侧的安装，但是导向组件200有利地包括允许在定位基座86的两侧上的安装和使用的对称部分，以增加在定位探头100方面的灵活性。因而，支架202的水平基底244将活组织检查导轨206形成为由第一和第二对单片眼镜插孔248，250位于侧面的活组织检查导向通道246，从而可以将单片眼镜254上的一对锁定钩252插入每对单片眼镜插孔248，250中，这取决于哪一个更靠近病人。可以将支架202直接连接到定位基座86(未示出)上，而不如图所示地将支架202安装到靶标导轨204上。支架202是机械上坚固的并能够支撑MRI活组织检查装置14的总重量。由于MRI活组织检查装置14不共用支架202，当需要接近浅的或深的病变时，可以最优化支架202以支撑MRI活组织检查装置14。
作为在定位和准备插入点时的初始步骤，插入单片眼镜标线片258中的导向衬圈256引导标记仪和/或画线手术刀(未示出)。其后可以将单片眼镜254去除或留在适当位置上，以便在除去限深器226的标线片232之外还引导套管222，限深器也可以保持用于引导套管222的导向衬圈260。将导向衬圈256，260去除允许单片眼镜254和限深器226的标线片258，232引导更大的组件，例如用于将可疑病变相对导向组件200定位的基准262。
以首先通过套管固定件216的接收套管毂224的毂接收器225的方式保持套管222的对准。在图中显示的变型中，套管222具有用于接收导入闭塞器268的端部开口的轴266，该导入闭塞器包括在固体闭塞器轴272的远端的穿刺尖端(例如扁平刀片)270。进入固体闭塞器轴272的斜切的凹陷部276对准套管222的套管侧孔278，并且由此终止于探头100(图1-3)。可以选择闭塞器268的材料以帮助定位套管222的套管侧孔276，否则该侧孔可能更加难以在MRI扫描部分中看到和定位。
套管毂224具有被连接到导向指旋轮282上的近侧圆柱形边缘280，该导向指旋轮282在近侧从套管固定件216的毂接收器225延伸出，用于旋转套管222，以将它的套管侧孔278相对于指旋轮282上与之相对应的且作为锁定槽284示出的可见标记定位。指旋轮282包括由夹在指旋轮282和套管毂224的近侧圆柱形边缘280之间的弹性密封环288和鸭嘴密封件290密封的中心通孔286。因而，包括进入锁定槽284的锁定条292的闭塞器268的插入封闭了中心通孔286并相对弹性密封环288形成动态密封。
在去除了闭塞器268后，可以将细探针298插入套管222，从而可以将在细探针298的近侧呈现的软管尖端300用于对手术位置吹气或用作其它目的，例如排放体液或将治疗或诊断剂通过细探针298的探针杆302插入到对准套管222的侧孔278的探针侧孔304。细探针298还包括锁定小突起306。
套管固定件216包括由弹簧向下偏压的卡扣接合在限深器226的倾斜捕捉器310上的摇杆插口308，防止套管222在无意中被缩回。套管固定件216可以通过在摇杆插口308的近侧致动臂312上的向下压力被脱开。被连接到套管固定器216的底部上的由弹簧向上偏压的摇杆插口314同样地接合限深器226。因而，在将限深器226在靶标导轨204上设置到所需的插入深度之后，可以使套管固定器216在远侧前进，且不会超射，随后当从其移去器具，例如闭塞器268，细探针298和MRI活组织检查装置14时，可以将该套管固定器保持就位。
将Z-止动部件基本集成到套管固定件中的第二导轨
在图5中，用于图1的MRI活组织检查系统10的另一种可供选择的深度导向组件400有利地将套管固定件402与限深器第二导轨集成于一体。导向组件400的限深器导向翼片406的尺寸被设定为能滑进支架410的追踪侧向通道408中。导向翼片406上的深度测量标记412(图5)在插入之前辅助预定位套管锁414。在图5A中，位于限深器第二导轨404的近端上的锁定致动器416在从近端看时为顺时针旋转90度，以便使限深器第二导轨404的螺纹或者凸脊状侧418从与套管锁414(图5B)的内槽420的螺纹接合中侧向脱离，从而允许进行粗调。然后，通过逆时针旋转锁定致动器416(图5、5B、5C)，套管然后将导向翼片406插入支架410的追踪侧向通道408中，直到锁定致动器416与支架410抵接阻止进一步插入(图5D)，将套管锁414锁定在限深器第二导轨404上。套管锁414包括上部和下部夹持凸缘422、424，它们锁定于上和下导向件426、428(图5B)上，该导向件限定了追踪侧向通道408，为套管222提供了一个坚固支撑(图5C、5D)。
在图6中，一个深度导向组件400a还包括一个带近端标识452的可翻转的单片眼镜450，近端标识452能够旋转单片眼镜轴454，该单片眼镜可卡入支架或者托架456上，最终使单片眼镜标线片458侧向或者向上旋转而脱离。在该方案中，支架456与夹持挂钩460连接，挂钩460在具有为钝箭头形的水平横截面基座或支柱464的近端垂直部分462上垂直滑动。有利地，套管锁470具有背侧杆472，允许通过以与外科医生进行典型的针式活组织检查相同的方式推动，使套管474及闭塞器476插入。用食指压下侧杆477，该侧杆能解锁套管锁470，并容许拇指将滑动锁470向前推向远端。侧杆477的释放使滑动锁470能锁定就位。通过相同的方式压下背侧杆472可将之移去。由于拇指平面很容易能够施加5lbs的力，对外科医生来说，这是一种比使用其它在手上的接触点更舒适的方法。在该方案中，通过将帽状杆478升起从而将闭塞器476释放，该帽状杆从位于比通常使用的小型环更容易夹持的闭塞器帽482一侧的支点480旋转180度闭塞器。
具有进行粗调的基本关节的第二导轨套管固定件
在图7中，显示了另一种深度导向组件500，其具有它的套管锁502的导向翼片504通过横梁508而与限深器第二导轨506分离设置。在图8中，套管锁502包括一个近侧半圆柱形槽510，其容纳限深器第二导轨506的向上部分。与近侧半圆柱形槽510对准的远侧半圆柱形槽512具有一个增大的内径，以容纳弹性关节513，弹性关节513的形状被设定为带纵向缺口514的圆形衬圈。从而，关节513的上和下端516、518(图8)相对夹持限深器第二导轨506，并与横梁508抵接。然而，如在图8-9中所示，关节513允许对套管锁502进行调节。如在图7中所示不调节时，套管锁502以及形成涡轮接合，使在限深器第二导轨506的一个近端的螺纹手柄520的旋转的限深器第二导轨506可用作套管锁502深度位置的微调，从而对套管固定件522及套管222的深度位置进行微调。特别地，初始深度在带有用于微控制的关节513及限深器第二导轨(“螺纹”)506的MRI机(“线圈”)(未显示)的外侧设定。如果需要附加的深度，套管锁502锁定于第一靶标导轨(未显示)，螺纹506从预期的附加深度返回，如图10、10A所示，然后将套管锁502在一次运动中推向新的深度，直到螺纹手柄520碰到第一靶标导轨的背面。
具有粗调及释放按钮的第二导轨套管固定件
在图11、11A、11B、12、13及13A中，另一种深度导向组件600包括一个限深器第二导轨(螺纹)602，其与(滑入到)设置于预定的Y-轴位置的第一靶标导轨204的导向翼片604(图11，11A，12，13，13A)平行设置。一个粗调按钮608向着套管锁610的背(远)侧设置，以便在插入到第一靶标导轨204(图11)中后阻碍其使用。向近端压下粗调按钮608，调动具有一个向远端突出并向内偏压的弹性指针的锁定板612(图11B)，牵引后者与限深器第二导轨602上的外螺线616的脱离接合，从而进行粗调。
特别参考图11B，锁定板612夹持于矩形上部和下部结构618、620之间，二者在它们的可更垂直设置的远端边角622、624和近端边角626、628处连接。一个顶部释放杆臂630具有一个向下的弧形远端部分632，该弧形远端部分与位于远端及近端边角622、626之间的矩形上部结构618相连，并且向上偏置且与一个与近端边角626连接的上侧圆柱形结构634间隔地设置。当向内(向下)推动顶部释放杆臂630的一个从近端向上延伸的手柄部分636时，导致弧形远端部分632与上侧圆柱形结构634接触，撬动矩形上部结构618远离锁定板612。同样地，一个底部释放杆臂640具有一个向上的弧形远端部分642，该弧形远端部分与位于远端及近端边角624、628之间的矩形下部结构620相连，并且向上偏置并与一个与近端边角628连接的下侧圆柱形结构644间隔地设置。当向内(向上)推动底部释放杆臂640的一个从近端向上延伸的手柄部分646时，导致弧形远端部分642与下侧圆柱形结构644接触，撬动矩形下部结构620远离锁定板612。当通过释放按钮650(位于顶部的一个显示于图11、11B、12、13中，底部的一个未显示)对顶部和底部释放杆臂630、640施压时，一个其上和下端654、656被保持在套管锁610中的垂直板簧652(图11B)偏压锁定板612的近端658，进而偏压远端的粗调按钮608。从而，套管锁610再次被锁定于限深器第二导轨602。
使用时，当从第一靶标导轨204上分离后(图11)压下粗调按钮608，可允许对套管锁610进行定位。当接近预期位置时，压下释放按钮650，以将螺纹封闭块610锁定于限深器第二导轨(螺纹)602上，并使粗调按钮608不致动。然后将螺纹手柄660转动到限深器第二导轨602的近端以进行精确定位。此外，通过滑动导向翼片604，将深度导向组件600连接到第一靶标导轨204(图12、13)。如果需要附加的深度，将套管锁610锁定于第一靶标导轨204，螺纹602从预期的附加深度退出，然后将套管锁602在一次运动中推向新的深度，直到螺纹手柄660碰到第一靶标导轨204的背面。
伸缩式深度导向组件
在图14-20中，一种用于图1的MRI活组织检查系统10的伸缩式深度导向组件700包括一个限深器第二导轨702，特别地，它包括一个与中间伸缩式导轨706滑动结合的限深器螺纹704。后者在套管222及闭塞器268甚至以更深的深度设定穿刺组织之前，与第一靶标导轨204(图i4A)滑动接合。在完全插入时(图14A)，中间伸缩式导轨706上的近端锁707(图14)与第一靶标导轨204接合。通过压下位于套管锁710远端侧上的使套管锁710与限深器螺纹704的涡轮结合脱离粗调按钮708，，对深度设定进行粗调。在套管锁710与中间伸缩式导轨706之间形成的棘轮机构防止了套管锁710的回缩，除非压下回缩按钮714。
使用时，在图15、15A中，伸缩式深度导向组件700向着支架202及第一靶标导轨204行进。在图16、16A中，在穿刺尖端270穿过单片眼镜254对组织进行穿刺之前，如此引导中间伸缩式导轨706直到近端锁707。在图17、17A中，位于限深器螺纹704上的一个后限深器翼片716行进直至其最远位置，由此使套管锁710、套管222及闭塞器268向远端行进至第一深度位置。在再次成像后或者在乳房中更深的已调整的位置进行第二次活组织检查后，响应于预期的调节，后限深器翼片716如图18所示逆时针旋转(如果从背面看时螺纹是反的，则顺时针旋转)使限深器螺纹704稍微回缩。然而，套管锁710与中间伸缩式导轨706接合并保持就位。在图19中，压下后限深器翼片716，使限深器螺纹704、套管锁712、套管222及闭塞器268行进至第二深度。如果初始深度过大，轻微压下近端锁并向后拉回套管锁撤退。这将使螺纹704暴露，而且可旋转它以设定新的、较浅的位置。在图20中，通过压下释放中间伸缩式导轨706的近端锁707，使伸缩式深度导向组件700从第一靶标导轨204上移开。
锁定爪锁定伸缩式深度导向组件
在图21-27中，一种可供选择的伸缩式深度导向组件800包括一个第一靶标导轨802(图21、23)，该导轨包括一个能在中间伸缩式导轨808的左向通道806(图23，23A)中滑动的导向翼片表面804。导向翼片表面804具有一个位于近端的棘爪槽810，该槽与由弹簧偏压的锁定爪812接合，锁定爪812通过中间伸缩式靶标导轨808的近端在侧向开口814内(图24、24A)枢转。套管固定装置824的夹持通道822的左向接合表面820上的齿816与锁定爪窗口814初始接合，迫使弹簧偏压锁定爪812逆时针旋转(从上面观察，图23A)。随着中间伸缩式靶标导轨808向远端滑动到导向翼片表面804上，弹簧偏压锁定爪812上的一个捕获尖端826(图24A)被推入棘爪槽810中，以防止近端的回缩。在中间伸缩式靶标导轨808的左向通道806近端上的限制阻止进一步朝远端移动。当从顶部看时，锁定爪812的右向远尖端828顺时针旋转，使齿816从锁定爪开口814中脱离结合，使套管固定件824朝远处滑过中间伸缩式靶标导轨808到达预定深度。完成后，套管固定件824的回缩导致齿816与锁定爪812的右向远尖端828抵接，进一步启动了顺时针旋转(从上面看)，使捕获尖端826与棘爪槽810脱离接合，并定位锁定爪812，如图23B所示，其中套管固定件824与未锁定的中间伸缩式靶标导轨808结合，并使二者均从第一靶标导轨802上脱离。
侧向导引的活组织检查盒
MRI活组织检查系统10的上述方案在活组织检查装置14与定位夹具16接合以进行组织穿刺前，能有利地远距离设置限深器。需要的是系统中各种元件以如下方式组装，即，减少单独消毒包装，减少由于接触套管或闭塞器的锋利的穿刺尖端而造成的损害的可能性，以及简化装配及使用。为此，分配的外壳部分地掩盖了穿刺构件(例如，可拆分的探头、末端封闭的套管、带有穿刺闭塞器的末端敞开的套管)，同时容许接近限深器以预先设定穿刺的预期深度。然后可以采用一个分配致动器(例如穿刺器)，通过同时从穿刺构件上移去分配外壳，进行接合和穿刺。
在图28、28A-C、29A-29F中，分配外壳被图示为一个侧向导引的活组织检查盒900，其将作为中间伸缩式导轨以进行固定的滑动套管902集成到第一靶标导轨802上(图21)靶标导轨套管。滑动套管902还包围了一个滑动穿刺器904，该穿刺器9042包裹了组织穿刺元件(即套管906及闭塞器908)作为预装配的组件。特别地，滑动穿刺器904包括一个与插入管(或臂)912连接的近端插入手柄910，插入管912具有一个沿着插入管912的左侧的内部纵向狭槽914(图28、28C)，且纵向狭槽914的远端与插入管912的远侧开口末端916相连通。滑动套管902具有一个外部纵向狭槽918，其边缘的尺寸和轮廓被设定为能与第一靶标导轨802沿着其左侧结合，并与内部纵向狭槽914对准，并且外部纵向狭槽918具有一个与滑动套管902的开口远端920连通的远端。一个滑动套管指针922仅在其近端与滑动套管902的外部纵向狭槽918连接，并远端向下延伸出其大部分长度。滑动套管指针922的近端部分向内突然加厚形成一个滑动套管关节923。
特别参考图28、28A、28B，可纵向定位的穿刺器臂，图示为指状柄924，具有向远端突出的上和下凸缘926、928，上和下凸缘分别具有能在插入管912中的上部和下部纵向狭槽934、936中滑动的上和下向外突出的闭塞器释放按钮930、932。凸缘926、928各自的近端向内卷曲并向远端折回，形成与指状柄基座942相连的上部和下部弹性端938、940，从而对凸缘926、928施加向外的偏压力。凸缘926、928夹住闭塞器908的闭塞器毂944。一个套管固定件，图示为一个闭塞器导向件946，包括一个圆柱形部分948，其环绕套管906的套管毂950。上部和下部引导臂952、954(图28、28C)与外部纵向狭槽918接合，并穿过滑动套管指针922的任意一侧。一个限深器环956初始邻近定位于与滑动手柄910邻近的插入管912上。
使用时，在图29中，侧向导引的活组织检查盒900处于除去包装的预装配的状态。滑动套管902将向远端行进，如箭头958所示，形成图29B的伸缩状态。然后压下上部和下部向外突出的闭塞器释放按钮930、932，以便从近端位置释放并向着远端滑动，直到锁定于如图29C中所示的远端位置。从而，指状手柄942使闭塞器908、闭塞器导向件946及套管906前进而从穿刺器管912中脱出，并进入行进的滑动套管902中。在图29D中，限深器环956沿着其上带有测量标记的插入管912已经行进到预期深度。然后，侧向导引的活组织检查盒900与第一靶标导轨802接合。特别地，滑动套管指针922在其中滑动，直到到达滑动套管关节923。在图29E中，使插入手柄910逆时针旋转90度(从近端看)。因此，指状手柄942也通过插入管912而旋转，直到与滑动套管902的外部纵向狭槽918对准，以解锁滑动穿刺器904。在图29F中，滑动穿刺器904由此向远端行进进入滑动套管902中。使闭塞器导向件946前进，从而使其上部和下部凸缘926、928与第一靶标导轨802接合。套管906和闭塞器908对组织进行穿刺直至限深器环956遇到滑动套管902而阻止进一步行进。
配备具有粗调和释放按钮的第二导轨套管固定件的盒
在图30A-30E中，活组织检查盒1000具有一个透明的滑动套管1002，该套管保持着图11-13的深度导向组件600。在图30A中，一个右侧狭槽1005占据了具有突出的滑动控制器1006的穿刺器管1004的全长。与滑动控制器1006联接的为闭塞器1008，该闭塞器缩入穿刺器管1004中以防止其穿刺尖端被无意接触到。这样，在图30B中，滑动控制器1006用作可纵向定位的穿刺器臂，该穿刺器臂已经向远端行进将闭塞器1008插入套管222中。另外，通过使用粗调按钮608和由透明滑动套管1002暴露出的微调螺纹手柄660，可在深度导向组件600上预先设定深度。在图30C中，活组织检查盒1000与第一靶标导轨802对准。在图30D中，活组织检查盒1000前进直到深度导向组件600完全与第一靶标导轨802接合。在图30E中，活组织检查盒1000回缩，而将深度导向组件600在原处。
通过一些实施例的描述对本发明进行了解释，这些解释性实施例的描述已经相当详细，但申请人并不是想限制，或者以任何方式将所附的权利要求的范围的限定到这样细节。另外的优点及改变对本领域技术人员来说都是很容易想到的。例如，其它成像模式可得益于本发明的一些方面。作为另一个例子，与侧板分开的一种基准标记可被定位于患者乳房外部上的特定点而作为导向组件的一部分。
作为一个例子，当解释性的方案包含了沿着Cartesian X-Y-Z坐标的定位和穿刺导向时，应当理解，与本发明一致的应用可采用其它调整的方案，例如球形、柱形或者其它坐标系统。应注意，上述各种方案允许旋转深度导向构件，从而使穿刺轴线不仅仅沿Z-轴，由定位夹具限定的X-Y轴正交的轴。这种调整穿刺角度的能力在某些穿刺进入患者将组织损害(例如，最小化穿刺组织的长度)减到最小，从而使在皮肤上的留下的任何伤疤不明显，避免某些组织(例如胸壁等)等例子中是很需要的。
作为另一个例子，其它类型的活组织检查装置在穿刺过程中可有利地被导引。John A.Hibner等人于2004年2月29日提交的申请号为11/025,556的题为“具有短联接的MRI相容驱动器的针芯取样活组织检查装置”的美国专利申请，其内容在此全部引入作为参考，在该文献中，描述了长程和短程针芯活组织检查。
作为又一个例子，当在MRI组中使用并增强使用期限望部分时，与本发明一致的应用也可采用其它成像模式(如超声、CT等)。

Claims (8)

1.一种在医疗过程中与活组织检查装置一起使用的设备，包括：
一个可选择地定位成与穿刺进入患者体内的预期轴线平行的导向元件；
一个与导向元件能够移动接合的固定件，将其可操作地设置为在插入过程中支撑与穿刺轴线对准的活组织检查装置的穿刺部分；以及
一个深度限制构件，与所选的固定件和导向元件二者中之一连接，其可调节以在预定插入深度阻止固定件的运动，所述深度限制构件与对应于预定插入深度的导向元件连接，所述深度限制构件包括一个与穿刺轴线对准的接收孔，将该接收孔可操作地设置成导向远端并限制活组织检查装置穿刺部分的近端。
2.如权利要求1所述的设备，其特征在于，所述固定件包括一个支撑活组织检查装置手柄部分的台架。
3.如权利要求1所述的设备，其特征在于，所述固定件与穿刺部分的近端接合，对准所述深度限制构件以抵接固定件，从而限制其运动。
4.如权利要求3所述的设备，还包括一个可操作地设置为阻止固定件从导向元件中回缩的锁定机构。
5.如权利要求4所述的设备，其特征在于，所述锁定机构包括一个接合于固定件和深度限制构件之间的锁闩。
6.如权利要求1所述的设备，还包括一个与导向元件联接的支架，且其偏离穿刺轴线横向垂直地延伸。
7.如权利要求6所述的设备，其特征在于，所述支架包括一个活组织检查导向件，其与穿刺轴线垂直对准，并可操作地设置为与活组织检查装置的手柄部分能够运动接合。
8.如权利要求7所述的设备，其特征在于，所述支架在穿刺轴线的下方垂直排列。
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US7708751B2 (en) 2010-05-04
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