CN1976638A - 包含可成像穿刺部分的mri活检器械 - Google Patents

包含可成像穿刺部分的mri活检器械 Download PDF

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CN1976638A
CN1976638A CNA2005800214885A CN200580021488A CN1976638A CN 1976638 A CN1976638 A CN 1976638A CN A2005800214885 A CNA2005800214885 A CN A2005800214885A CN 200580021488 A CN200580021488 A CN 200580021488A CN 1976638 A CN1976638 A CN 1976638A
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蒂莫西·G·迪茨
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Devicor Medical Products Inc
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Ethicon Endo Surgery Inc
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Abstract

作为活检系统的部件的闭塞器通过指示侧窗孔在包围套管中的位置而增强与磁共振成像(MRI)的一起使用。套管(例如可拆卸探头、尺寸适于容纳针芯活检探头的套筒)包括用于获取组织样品的侧窗孔。当闭塞器代替活检装置插入到套管中时，在闭塞器的轴中形成与窗孔对应的切口。进入切口中的凹穴沟槽还可接受含水材料以使窗孔明显。另外，通过轴的侧向表面连通并靠近侧窗孔的一系列尺寸变化的窗孔(例如孔，狭条)容纳含水材料，以增强在MRI图像中的可视性，甚至通过套管/闭塞器增强在歪斜的MRI部分中的可视性。

Description

包含可成像穿刺部分的MRI活检器械
相关申请的交叉参考
本申请要求Hughes等人于2004年5月21日提交的题为“MRIBIOPSY DEVICE”、序列号为60/573,510的美国临时专利申请的优先权，其公开的内容通过全文引用包含于本申请中。
本申请要求Hughes等人于2005年3月10日提交的题为“MRIBIOPSY DEVICE”、序列号为11/076,612；Hughes等人于2005年4月12日提交的题为“MRI BIOPSY DEVICE LOCALIZATIONFIXTURE”、序列号为11/103,959；Tsonton等人于2005年4月12日提交的题为“MRI BIOPSY APPARATUS INCORPORATING ASLEEVE AND MULTI-FUNCTION OBTURATOR”、序列号为11/103,718的三份美国非临时专利申请的优先权，所有这三篇文献的公开内容均通过全文引用包含于本申请中。
技术领域
本发明总的涉及成像辅助组织取样方法，更具体地涉及用于相对于用于获取皮下活检及切除病变的磁共振成像(MRI)乳房线圈定位活检探头的改进方法。
背景技术
近年来，针芯活检装置已经与成像技术接合以更好地靶标乳房组织中的病变。一种可从市场上购买的产品是EthiconEndo-Surgery Inc.的商品名为MAMMOTOMETM的产品。这样的装置的实施方式在1996年6月18日授予Burbank等人的美国专利US5,526,822中进行了描述，其内容通过引用包含于本申请中。其手柄接收机械动力和电力以及来自远程定位的控制模块的真空辅助，所述控制模块远离磁共振成像(MRI)机的强磁场。
通过所述参考文献可知，所述器械是图像引导经皮针芯乳房活检器械。其由真空辅助，用于回收组织样品的一些步骤已经实现了自动化。在将组织从身体切下之前医生将这种装置用于(使用真空)采集“活动”组织。这允许对硬度变化的组织取样。另外，使用侧向开口的窗孔，避免不得不刺入到病变中，而刺入到病变中容易将团块推开，引起轨迹转移，或者造影剂在其中循环引起可在可疑病变中模拟增加的血肿。窗孔可围绕探头的纵向轴线旋转，从而允许获得多个组织样品而不需要重新定位探头。这些特征允许较大病变的完全取样并完成小病变的切除。
在MRI中，在成像过程中磁场和RF场两者的存在为每个需要在MRI系统的成像区域附近或者之中定位或操纵的器械都设置了限制。MRI系统施加了强恒磁场(例如1特斯拉)，以对准身体的原子的电子。然后施加磁场梯度以扰动对准的电子。当电子恢复准直时，发出一定能被检测和解析的弱RF信号。对这样的环境的一致性要求器械本质上必须是非铁磁性的，使其不被磁场吸引并因此成为障碍(posing)，这会对安全问题构成障碍。对在需要成像的患者附近(或者插入或植入到其中)使用的任何物体都应有这种考虑，这是因为如果是铁磁性的，磁场使这样的物体或者植入物受到不期望的力和扭矩的影响。另外，电子仪器应能够耐受静态以及脉冲磁场和RF场，以便在这些场的存在下操作。此外，植入物或者仪器不能过度地承受由于施加的RF场产生的涡流的感应热。最后，仪器不能形成模糊或扭曲目标图像的过多成像假象。
为了解决这些限制问题，MRI相容性活检器械一般由非铁材料装配而成；但是，有时候也可使用MRI可成像的其它材料。在一些情况下，可成像性取决于缺乏MRI RF返回图像与被相邻组织反射的图像的对比。而且，有时候也包括铁磁粒子或者用于保持液相顺磁离子的液腔。
虽然这些公知的MRI活检装置提供了MRI相容性和一定的可成像程度，仍然需要进一步的改进。更特别地，非常需要这样的MRI相容性活检装置：增强在MRI相容性穿刺部分中的取样窗孔定位，甚至在倾斜穿过探头的MRI扫描部分中亦如此。
发明内容
本发明通过如下方式克服现有技术的上述和其它缺点，即，提供一种用于使用由磁共振成像(MRI)相容性材料制成的套管进行的最小程度侵入到人体乳房组织中的医疗手术的闭塞器，所述套管具有靠近远端的横向开口且其尺寸适于容纳针芯活检切割元件的纵腔。特别地，闭塞器具有由MRI相容性材料形成的轴，其尺寸适于代替针芯活检切割元件插入到套管中。靠近套管的横向开口在闭塞器中形成的MRI可成像的凹槽构造为容纳增强其识别的MRI可视材料。
通过附图及其描述，本发明将更加清楚。
附图说明
包含于并构成本说明书一部分的附图示出了本发明的实施方式，并与上面给出的本发明的总体描述和在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)相容性活检系统的透视分解图，包括有利地MRI相容和可成像的导向套筒和闭塞器，并提供了治疗零件；
图2是图1的MRI相容性活检系统的定位夹具的导引部分和分解的MRI活检装置的分解透视图；
图3是安装在定位夹具的导引部分上的图2的MRI活检装置的透视图；
图4是作为替代的导引部分的分解透视图，包括支撑具有开口远端和侧窗孔的套筒的托架，具有穿刺尖的成像闭塞器和还用于设置用于图1的MRI相容性活检系统的标记物的流体连通的管心针；
图5是支撑具有带流体腔和穿刺尖的成像/标记闭塞器的套筒的另一种替代导引组件的分解透视图；
图6是沿着具有开口远端和侧窗孔及导引器的套筒、具有独木舟式标记物凹槽的闭塞器的图5的成像闭塞器的纵剖面的右侧剖视图；
图7是沿着用于图1的MRI相容性活检系统的具有侧窗孔和与导引器一起使用的穿刺尖的套筒、具有独木舟式标记物凹槽的成像闭塞器的纵剖面的右侧剖视图；
图8是沿着用于图1的MRI相容性活检系统的具有侧窗孔和与导引器一起使用的开口远端的套筒、具有非圆形横截面和穿刺尖的成像闭塞器的纵剖面的右侧剖视图；
图9是沿着用于图1的MRI相容性活检系统的图7的具有导引器的套筒、具有非圆形横截面的成像闭塞器的纵剖面的右侧剖视图；
图10是沿着具有非对称穿刺尖和带有成像闭塞器的窗孔的套筒的纵剖面的右侧剖视图；
图11是图10的成像闭塞器的近端部分沿着线11-11的横剖面的主视图，以暴露其X形剖面；
图12是图10的成像闭塞器的远端部分沿着线12-12的横剖面的后视图，示出使脱垂到套筒的侧窗孔中的组织成形的X形剖面；
图13是图10的可选成像闭塞器的近端部分沿着线11-11的横剖面的主视图，以暴露其带脊的半圆柱形剖面；
图14是图10的可选成像闭塞器的远端部分沿着线12-12的横剖面的后视图，示出其带脊的半圆柱形剖面，使脱垂到套筒的侧窗孔中的组织成形；
图15是沿着作为替代的成像闭塞器的纵剖面的右侧剖视图，具有非对称穿刺尖并具有捕获MRI可视插入物的独木舟式凹槽；
图16是沿着作为替代的成像闭塞器的纵剖面的右侧剖视图，具有非对称穿刺尖并具有保持在远端定位的MRI可视插入物的内部近端连通的腔；
图17是沿着作为替代的成像闭塞器的纵剖面的右侧剖视图，具有构造为将体液吸到独木舟式凹槽中的内部近端连通的腔；
图18是沿着将组织吸到套筒的侧窗孔中以显示MRI可视轮廓之后的作为替代的图17的成像标记闭塞器的纵剖面的右侧剖视图；
图19是沿着作为替代的图17的成像标记闭塞器的纵剖面的右侧剖视图，其中MRI可视材料包含在护套覆盖的侧槽中；
图20是沿着组装的成像标记闭塞器的纵剖面的右侧剖视图，包括具有侧槽和被具有模制的非对称穿刺尖的穿刺护套包裹的实心的管心针；
图21是沿着闭塞器的纵剖面的右侧剖视图，具有开口远端和带有真空辅助排气的侧窗孔，以便允许标记腔充满体液以展示MRI可视材料；
图22是沿着闭塞器的纵剖面的右侧剖视图，该闭塞器具有穿刺的远端和带有真空辅助排气的侧窗孔，以便允许标记腔充满体液以展示MRI可视材料；
图23是沿着闭塞器的纵剖面的右侧剖视图，该闭塞器具有封闭的钝的远端和容纳有MRI可视材料(例如钆溶液、水溶液)的标记物腔，该标记物腔具有定位并包括流体通道的与套筒的侧窗孔对应的MRI暗塞(例如胶原、非铁金属、塑料)；
图24是沿着闭塞器的纵剖面的右侧剖视图，该闭塞器具有穿刺的远端和含有MRI可视材料(例如钆溶液、水溶液)的标记物腔，该标记物腔具有定位并包括流体泄露通道的与套筒的侧窗孔对应的MRI暗塞(例如胶原、非铁金属、塑料)；
图25是沿着闭塞器的纵剖面的右侧剖视图，该闭塞器具有穿刺的远端和含有MRI可视材料(例如钆溶液、水溶液)的标记物腔，该标记物腔具有定位并包括流体通道以便与闭塞器侧窗孔连通的的MRI暗塞(例如胶原、非铁金属、塑料)；
图26是具有切口和开口远端的套筒的侧视图，其中以双点划线显示了用于图1的MRI相容性活检系统的成像闭塞器；
图27是沿着与图26的套筒的纵向轴线垂直的线27-27的剖视图；
图28是图26的闭塞器的侧视图，其中沿着燕尾形接头与底部部分纵向滑动接合的上部被向近侧拉动，以暴露套筒中的切口；
图29是沿着与图28的闭塞器的纵向轴线垂直的线29-29的剖视图，显示了椭圆形套筒腔；
图30是具有一体式刃的套筒的侧视图，该一体式刃与具有环形切割器腔和下面的真空腔的轴连接；
图31是沿着与图30的套筒的纵向轴线垂直的线31-31的剖视图，显示出环形切割器腔和下面的真空腔；
图32是图31的套筒的侧视图，其被切除以暴露可选择性关闭套筒中的切口的可旋转闭塞器；
图33是沿着与图32的套筒的纵向轴线垂直的线33-33的剖视图；
图34是MRI影像的显示，其中所选定的图像部分大致沿着共轴的套筒和图28的闭塞器的纵向长度穿过，并且闭塞器处于关闭位置以封闭套筒的切口；
图35是MRI影像的显示，其中所选定的图像部分沿着线35-35垂直于共轴的套筒和图34的闭塞器的纵向长度穿过；
图36是MRI影像的显示，其中所选定的图像部分大致沿着共轴的套筒和图28的闭塞器的纵向长度穿过，并且闭塞器处于打开位置以打开套筒的切口；
图37是MRI影像的显示，其中所选定的图像部分沿着线37-37垂直于共轴的套筒和图36的闭塞器的纵向长度穿过；
图38是沿着闭塞器的远端部分的纵剖面的右侧剖视图，该闭塞器具有由MRI可视标记物致动并与标记物展开腔连通的侧槽；
图39是沿着闭塞器的远端部分的纵剖面的右侧剖视图，该闭塞器具有由侧向标记物带致动并与下面的真空腔连通的侧槽；
图40是沿着闭塞器的纵剖面的右侧剖视图，该闭塞器具有带展开斜坡和标记物/工具腔的侧槽；
图41是沿着芯针的纵剖面的右侧剖视图，该芯针具有围绕与纵向标记物/工具腔连通的开口远端的环形圈MRI可视标记物；
图42是生产用于MRI活检装置的聚酰亚胺的工艺的示意图；
图43A-43D是圆形、椭圆形、正方形/矩形和复杂形状套筒的剖视图；
图44A是设置在压缩夹具中的执行套筒的主视图；
图44B是侧向压缩形成椭圆剖面形状后的图44A的套筒的主视图；
图44C是加热形成粘性永久形状后的图44B的套筒的主视图；
图45A是定位在经过套筒插入的缩腰椭圆芯轴的成形夹具中的执行圆套筒和设置在具有相对收缩部分的压缩板之间的套筒的主视图；
图45B是在压缩板的成形夹具抵靠芯轴压缩和加热后执行圆套筒的主视图，其中执行套筒位于其间以获得缩腰椭圆形状；
图45C是从图45B的成形夹具释放后的缩腰椭圆套筒的主视图；
图45D是成形夹具的主视图，其中压缩板和芯轴的形状被设置成限制用于在整个圆周压缩和加热执行套筒，以形成缩腰椭圆形；
图45E是所述缩腰椭圆形套筒在从图45D的成形夹具中释放之后的主视图；
图46是具有用于嵌件注塑的激光形成的近端安装孔和侧窗孔的套筒的透视图；
图47A是经过套筒的近端部分的纵剖面的右侧剖视图，该套筒具有与套筒套节嵌件注塑在一起的激光形成通孔；
图47B是经过套筒的近端部分的纵剖面的右侧剖视图，该套筒具有嵌件注塑以形成套筒套节的激光形成浮凸区域；
图48是连接在闭塞器或者套筒的锥形远端穿刺尖中的狭缝中的双尖头扁平刀的俯视示意图；
图49A是闭塞器或套筒的主/副锥形穿刺尖的俯视示意图；
图49B是图49A的主/副锥形穿刺尖的主视图；
图50是用于使图49A-49B的穿刺尖形成正角的插入扭矩的几何示意图；
图51是用于使图49A-49B的穿刺尖形成负角的插入扭矩的几何示意图；
图52A是用于套筒或者闭塞器的穿刺部分的作为替代的扁平三角切割元件的透视图；
图52B是图52A的替代扁平三角切割元件的俯视图；
图53是闭塞器的左侧正视图，其具有扁平刀状穿刺尖、在侧槽和装配在具有用于闭塞器套节的外部接合零件的近端上的流体之间连通的腔；
图54是图53的闭塞器的主视图；
图55是图54的闭塞器沿着线55-55的纵剖面的左侧剖视图；
图56是图53的闭塞器沿着沿远离套节接合部分的线56-56的剖面的主视图；
图57是图53的闭塞器沿着沿穿过套节接合部分的线57-57的剖面的主视图；
图58是闭塞器的左侧正视图，其具有扁平穿刺尖、在侧槽和近端以及纵向间隔设置的增量变化直径的垂直成像孔之间连通的腔；
图59是图58的闭塞器的俯视图；
图60是图58的闭塞器沿着沿线60-60的剖面的后视图，以虚线显示穿刺尖；
图61是闭塞器的左侧正视图，其具有扁平刀状穿刺尖、在侧槽和近端之间连通的腔以及具有增大的截面积的狭条成像腔室；
图62是图61的闭塞器的俯视图；
图63是图61的闭塞器沿着沿穿过侧槽的线63-63的剖面的后视图，以虚线显示穿刺尖；
图64是图61的闭塞器沿着沿穿过狭条成像腔室的线64-64的剖面的主视图；
图65是闭塞器的左侧正视图，其具有扁平穿刺尖、在侧槽和近端之间连通的腔以及作为替代的一系列狭条成像腔室；
图66是图65的闭塞器的俯视图；
图67是图65的闭塞器沿着穿过侧槽的剖面的后侧正视图，以虚线显示穿刺尖；
图68是图65的闭塞器沿着穿过线68-68的剖面的主视图；
图69是具有30度角的侧槽的闭塞器左侧的MRI图像；
图70是具有60度角的侧槽的闭塞器左侧的MRI图像；
图71是独木舟式切槽的侧槽的闭塞器左侧的MRI图像；
图72是图53的闭塞器的左侧MRI图像；
图73是图53的闭塞器的左侧MRI图像，其具有含浸渍的胶原塞的腔；
图74是图58的闭塞器的左侧MRI图像，其填充有液体凝胶；
和
图75是图61的闭塞器的左侧MRI图像，其填充有钆。
具体实施方式
参照附图，其中在所有附图中相同的附图标记表示相同的元件，在图1中，磁共振成像(MRI)相容性活检系统10包括引导套筒和导引器闭塞器的引导件，所述套筒和导引器闭塞器与活检装置本身分离，并有利地包括改进的穿刺部分、MRI成像标记物和流体控制能力。安装规定允许沿着需要的轨道精确穿刺而不会过射。
MRI相容性活检系统10包括控制模块12，其通常设置在包含MRI机(未显示)的屏蔽室之外或者至少间隔设置以减轻与其强磁场和/或灵敏的射频(RF)信号检测天线的有害相互作用。控制模块12控制MRI活检系统14并为其供电，该MRI活检装置可相容地在紧邻MRI机处使用。MRI活检装置14的一个例子是前述MAMMOTOMETM仪器。MRI活检装置14通过与乳房线圈18连接的定位夹具16精确定位，该乳房线圈又支撑着患者(未显示)。可从市场上购买的乳房线圈18的例子包括Waukesha WI的MRIDEVICES CORPATION生产的BIOPSY BREAST COIL MODELBBC。导引组件20，特别是套筒22，有利地与定位夹具16连接，以增加在手术的特定部分期间与MRI活检装置14的选择性使用相结合的成像和治疗灵活性和准确性。导引组件20可包括一个或多个闭塞器24，其中示出的一个在插入期间和随后的MRI活检装置14没有插入其间的手术部分期间密封套筒22。设置深度限位器26用于与定位夹具16一起使用，以有利地防止套筒22过度插入、套筒22的无意回缩和/或增加套筒22沿着Z轴设置到理想位置的精确性。
为了方便起见，在本文中采用惯例，通过笛卡儿坐标在乳房组织中以定位夹具16和在此后将器械(例如套筒22)定位在该位置的位置为参照定位可疑病变，而不需要对区域连续成像。如同将在下面详细描述的那样，沿着乳房的外侧相对于患者胸部的中间平面压缩的多孔屏障限定了X-Y平面，其中X轴与直立的患者垂直(垂直对分)，当由面对定位夹具16的向外暴露部分的医生观察时其对应于左右向轴线。与靠近患者的皮肤的定位夹具16连接或者相对于其定位的基准标记物(未显示)定义了该平面的原点。与该X-Y平面垂直并沿着乳房的中间侧延伸的是Z轴，其通常对应于MRI活检装置14插入的方向和深度，但是应当理解，可允许与该Z轴成一角度插入的变化。因此，为了清楚起见，术语Z轴可与“穿刺轴”相互替代使用，尽管后者可以、或者不可以与用于定位患者上的插入点的空间坐标垂直。
使支撑大小/深度限位器的示踪轨道与支撑活检装置的重量的活检轨道分开有利地减少了各种元件之间的干扰，允许顺序操作，其中一些元件可选择性地安装或者除去而不与其它元件干扰。
在使用时，通过将索操纵卷筒30设置在从控制模块12的一侧突出的索操纵连接座架32上，准备使用MRI相容性活检系统10。卷绕于索操纵卷筒30上的是配对的电缆34和机械索36，分别用于连通控制信号和切割器的旋转/行进运动。特别是，电缆34和机械索36都具有与控制模块12中各自的电端口40和机械端口42连接的一端，另一端与容纳MRI活检装置14的机座连接。当不使用时可保持机座44的MRI对接槽46通过对接站安装托架48钩在控制模块12上。
安装在壁上的界面锁定盒50为控制模块12上的锁定端54提供系绳52。有利地，系绳52被独特地终止并具有较短的长度以避免控制模块12与MRI机器因疏忽而定位得太近。串联外壳56可有利地将系绳52、电缆34和机械索36与控制模块12上它们各自的端口54、42、44对准。遥控键盘58可与电缆34远距离连接，特别是当插入到定位夹具16中之后对MRI活检装置14本身的控制不容易实现时，增加医生对MRI活检装置14的控制。
通过连接在控制模块12和挡住流体和固体残渣的真空罐64的出口62之间的第一真空管60提供真空辅助。管道套件66实现控制模块12和MRI活检装置14之间的气体连通。具体说来，第二真空管68与真空罐64的入口70连接。第二真空管68分成与MRI活检装置14连接的两个真空管72、74。随着MRI活检装置14安装到机座44中，控制模块12执行功能检查。将盐溶液手动注入活检装置14中用作润滑剂并帮助实现真空密封。控制模块12致动MRI活检装置14中的切割器机构(未显示)，监测整个行程。
还装配了部分在MRI机附近使用的MRI相容性活检系统10。一般来说已知的是乳房线圈18与其它主体支撑垫(未显示)一道设置在MRI机的门架上。连接在乳房线圈18的每一横向侧上的凹槽中以接触悬垂暴露于其间的患者乳房的定位夹具16包括水平中板80、可重复使用的底部组件82、侧向组件84和定位基座86。定位夹具16还与一次性中栅90和侧窗孔(或者多孔板)92组装。
底部组件82设置在乳房线圈18的选定的侧向凹槽中。中栅90与中板80的中缘连接，该中板大致沿着位于容纳患者乳房的选定乳房窗孔94的内缘下方的乳房线圈18的纵向轴线垂直对准。当患者由此定位并对乳房的外部区域消毒后，侧窗孔92向下滑到侧向组件84的三侧机架引导件96中，该侧向组件又设置在中板80上。底部组件82和侧向组件84沿着Z轴彼此相对运动，压缩位于中栅90和侧窗孔92之间的患者乳房。在侧向组件84、底部组件82和中板80之间形成的机构保持这种压缩。
可将造影剂注射到患者体内增强成像。门架行进到MRI机镗腔中对定位夹具16和乳房组织成像。侧窗孔92上的基准标记物定位并表示为X-Y-Z坐标的原点。然后可疑病变定位在图像及其上的选定点内，以确定其相对于原点的位置。应理解，通过具有由可成像材料形成的侧窗孔92，可方便初始扫描的X-Y-Z轴的定向，从而除了基准标记物的原点之外还产生一个X-Y平面。随着目标位置的确定，门架从MRI机的镗腔中退出。
定位基座86沿着侧向组件84的X轴滑动接合，并限定了用于将单个靶标轨道(“导轨”)98定位在选定Y轴坐标的垂直导引。轨道98又提供沿着Z轴的深度导引，用于将深度限位器26和外壳44定位在需要的Z轴坐标处。深度限位器26闭锁在轨道98上。此后，标记仪器(未显示)可经过深度限位器26插入，在乳房上标记插入点。此后，深度限位器26离开路径。浅表注射麻醉剂，接着通过在标记位置划割并随后将麻醉剂更深地注射到划割处。深度限位器26然后重新定位到轨道98上需要的Z轴坐标参考处。
闭塞器24插入套筒22并可靠近套筒22的任何(侧面和/或远端)窗孔定位，为乳房组织形成封闭的表面。闭塞器还可设置成或者形成增强窗孔位置的可视性的形状。一个或者另一个闭塞器24和套筒22形成锋利的尖端(未显示)以穿刺乳房组织。例如，如果使用具有开口端的套筒22，闭塞器可提供锋利尖端。
闭塞器24插入到套筒22中，二者的组合体由轨道98导引到适当的方向，直到到达由深度限位器26设定的精确深度。一旦完全插入，深度限位器26防止过度插入。套筒22有利地闭锁轨道98和/或深度限位器26，防止因疏忽而造成的回缩，比如当闭塞器24退出受到来自乳房组织的压力时，或者后者当MRI活检装置14的探头从套筒22退出时。
门架运动到MRI机的镗腔中，患者被再次成像以确信套筒22相对于可疑病变放置。有利的是，当用于后续活检样品而定位时，套筒22和/或闭塞器24的可成像材料(可包含或者包括标记物材料)增强了确定定位的套筒22及其套筒窗孔102的位置的能力。
通过回缩门架将患者从MRI机中移开，容纳在机座中的活检装置14被置入定位夹具16中。将保护盖(未显示)从MRI活检装置14的探头100上除去，并将闭塞器24从套筒22中除去。在图2和3中显示出将机座44安装在轨道98上，其中机座44和MRI活检装置14的组合体在轨道98上滑动，该轨道98已经定位相对于基座86和侧向组件84定位到某一位置。套筒22和探头100的特征有利地从视觉上和机械的方式定向探头100的侧窗孔104与套筒侧窗孔102，同时形成气密封。有利的是，机座44和/或探头100可闭锁在轨道98或者套筒22上，以确保完全插入并防止过度插入和因疏忽造成的回缩。机座44允许将手持使用的MRI活检装置14在其与定位夹具16的连接中具有足够的支撑，精确地保持其位置并避免或者减小由探头100携带的负载。
此后，MRI相容性活检系统10可通过致动与真空辅助接合的切割器机构获取组织样品，退出切割器并退出组织样品，后者或许还需要真空辅助。探头100/套筒22的组合体能够相对于它们的纵向轴线手动或者也许能自动旋转需要的角度，以获取另外的样品，或者可通过进一步寻求真空辅助在当前方向获取另外的样品。切割器然后行进以关闭探头侧窗孔104，机座44从定位夹具16退出，从而将探头100从套筒22除去。
其它步骤或者步骤的组合可在该点被执行，例如使用探头100，专门的闭塞器24(例如管心针)，或者仅仅套筒22，将各种试剂导引到活检手术部位。例如排出流体、插入麻醉剂、插入止血剂、用气压吹气和插入标记物用于后续活检部位的定位，或者其诊断或者治疗手术。
患者然后通常返回到MRI机的镗腔以再次成像，确信至少一部分可疑病变的除去和标记物的可能设置。在再次成像期间，套筒22由闭塞器或者管心针24密封。此后，除去定位夹具16，包扎患者并除去门架，MRI相容性活检系统10的一次性部分被作为医疗垃圾抛弃。
特别参考图2-3，单个靶标轨道98有助于各个元件的相继安装。首先是深度限位器26，然后是套筒22(如图1所示)，接着是活检工具14在单个靶标轨道98上滑动。作为替代，如图2-3所示，单个靶标轨道98可接收深度限位器26，然后使用活检装置14，但不需要独立的套筒22。穿刺到患者乳房中的最大深度由深度限位器26在单个靶标轨道98上的位置预设。机座44和单个靶标轨道98之间的接合机构(未显示)和/或由制动片形成的接合机构，示为深度限位器26的上部轨道夹持臂112上的向上突出的销110以及扣合在向上突出的销110上的向下弹性偏压的摇臂锁114，可防止因疏忽造成的MRI活检装置14的回缩。机座44可通过摇臂锁114的近端致动臂116上的向下的压力而脱离。
单个靶标轨道98可沿纵向设置成向近端充分延伸的尺寸，使MRI活检装置14在探头100与患者皮肤接触之前与单个靶标轨道98接合。单个靶标轨道98还设置成不向近端延伸到其不能在闭腔MRI机(未显示)中使用的程度。这样的MRI相容性活检系统10被认为将手术周转时间缩短到最短，短于45分钟，如上所述。但是，尽管快速周转，放射科医师可精确地将探头100定位到病变中心的2mm(最大5mm)之内。此外，在手术期间(在平台的两侧)放射科医师可以对患者最少的重新定位而最大程度地接近两个乳房(左或右)。而且，只需要最小量的力穿刺组织，例如小于4lbs。尽管深度限位器26用于防止过射，在进一步插入探头100之前用于重新定位深度限位器26的零件允许在靶标另一位置的临床灵活性。
在图4中，作为替代的用于MRI相容性活检系统10的导向组件200包括托架200，其与靶标轨道204连接并提供支撑MRI活检装置的活检轨道206，两个轨道204、206都与Z轴对准。靶标轨道204与定位支柱86(在图4中未显示)连接，并调整为与需要的Y位置垂直。圆形连接点208可形成与定位基座86可旋转接合，允许靶标引导件倾斜。
靶标轨道204的侧面210包括上凸缘212和下凸缘214，每个具有用于滑动容纳套筒固定架216的L形横截面。每个凸缘212、214中的侧向突出脊218的垂直列用作套筒固定架216的锁定表面。侧槽容纳在凸缘212、214之间。套筒固定架216通过具有其靠近容纳在套筒固定架216的套节插座225中的套筒套节224导引套筒222，并通过深度限位器226在远端定位并受到限制。
深度限位器226包括与侧槽220接合的滑动元件228。深度限位器外壳230与其连接，终止在标线片232中。锁定杆234垂直销接在向远端开口的凹槽(未显示)中，该凹槽限定在深度限位器226中，并且侧向部分236从其弹性偏离，使向远端突出的足238抵靠脊218枢转并与其接合，尤其是抵抗近端运动。依靠深度限位器外壳230的向远端打开的凹槽向近端压缩侧向部分236释放向远端突出的足238，允许向远端重新定位深度限位器226。
活检装置10的穿刺轴线与由靶标轨道204和活检轨道206限定的轴对准，靶标轨道204和活检轨道206分别侧向垂直正交错位。从靶标轨道204延伸一个水平面和从活检轨道206延伸一个垂直面在作为穿刺轴的共用中心线处相交。使活检轨道206垂直对准并与穿刺轴平行有利地为活检装置14提供了支撑，并且扭转负载最小，而扭转负载否则会使插入的远端产生偏转。因此，甚至对于较重和细长的装置而言，将其远端定位并保持在需要的插入点的5mm内甚至是2mm内是可以实现的。因此，可执行“不需要手”的手术，避免了穿刺的不便和不实际性，在所示方案中可由在穿刺轴上方垂直移位来代替。特别是，具有可与靶标轨道204的任一侧接合的托架可提供进一步的垂直对称，并可允许操作人员利用由乳房线圈18赋予的全部空间。
虽然“不需要手”的能力对于单个插入/多样品活检装置而言是有利的，但应当理解，本文中描述的具有预设深度限位器的这种穿刺导引甚至可应用到采用每个样品单次插入的针芯活检的轻质活检装置。特别是，在连续成像方面矫正设置不需要条件。当不需要手时，避免了插入期间的过度穿刺和因疏忽造成的移位。
靶标轨道204的底部燕尾通道240容纳在托架202上的顶部燕尾伸出部分242，其中托架202可在其间滑动。应当理解，当从近端观察时，在本文中显示为安装在定位基座86的右侧上，但是导引组件200有利地包括对称部件，允许在定位基座86的任一侧安装和使用以增加在定位探头100时的灵活性。因此，托架202的水平基部224形成活检轨道206，作为由第一和第二对单片眼镜插座248、250设置在侧面的活检导引通道246，使单片眼镜254上的一对锁定钩252可插入到任一对单片眼镜插座248、250中，这取决于哪一个离患者更近。与如图所示的将托架202安装到靶标轨道204不同的是，托架可直接与定位基座86(未显示)连接。托架202具有机械坚固性，并可支撑MRI活检装置14的总重量。由于MRI活检装置14不能共用托架202，当需要进入浅或深的病变时，托架202可被优化为支撑MRI活检装置。
插入单片眼镜标线片258中的导套256导引标记仪器和/或划痕手术刀(未显示)，作为定位和准备插入点的最初步骤。单片眼镜254此后可被除去或者留置在原位，除了深度限位器226的标线片232之外导引套筒222，该标线片也可保持用于导引套筒222的导套260。将导套256、260除去允许单片眼镜254的标线片258、232和深度限位器226导引更大的元件，例如用于将可疑病变相对于导引组件200定位的基准。
套筒222的对准首先由穿过容纳套筒套节224的套筒固定架216的套节单片眼镜225保持。在所示方案中，套筒222具有带开放末端的轴266，用于容纳在实心闭塞器轴272的远端包括穿刺尖(例如扁平刀)270的导引器闭塞器268。进入实心闭塞器轴272的带斜边的凹槽276与套筒222的套筒侧窗孔278对准，因而最终作为探头100(图1-3)。闭塞器268的材料可选择为辅助在套筒222的套筒侧窗孔276中定位，否则可能更难以在MRI扫描部分中观察和定位。
套筒套节224具有与导引指轮282连接的近端圆柱边缘280，所述导引指轮从套筒固定架216的套节插座225向近端延伸，以对应的指轮282上的图示为锁定槽284的视觉标记为参照，将套筒222旋转定位到其套筒侧窗孔278中。指轮282包括由挡在指轮282和套筒套节224的圆柱边缘280之间的弹性密封环288和鸭嘴密封件290密封的中央通孔286。因此，包括进入锁定槽284中的锁定翼片292的闭塞器268的插入封闭了中央通孔286并基于弹性密封环288形成动态密封。
在除去闭塞器268之后，可将管心针298插入到套筒222中，使管心针298的近端形成的软尖头300可用于对手术部位吹气或者用作其它目的，诸如经过管心针298的管心针轴302向与套筒222的窗孔278对准的管心针窗孔304排出体液或者插入治疗剂或者诊断剂。管心针298还包括锁定翼片306。
套筒固定架216包括扣合在深度限位器226的倾斜制动片310上的向下弹性偏压的摇杆锁308，防止因疏忽而造成的套筒222回缩。套筒固定架216可通过摇杆锁308的近端致动臂312上的向下的压力脱离接合。与套筒固定架216的底部连接的向上弹性偏压的摇杆锁314同样与深度限位器226接合。因此，在深度限位器226设置在靶标轨道204上需要的插入深度之后，套筒固定架216可向远端行进而不会过射，并且随后当除去其间的执行部分时可保持位置，例如除去闭塞器368、管心针298和MRI活检装置14。
在图5中，用于MRI活检系统10的另一替代导引组件400包括与初级靶标轨道404的底部通道403接合的托架402。为了提供图1-3的MRI活检装置14的附加导引，次级靶标轨道406包括沿着初级靶标轨道404的纵向导引翼片410导引的侧向通道408。当全部接合于其上时，在爪弹簧414的促动下围绕次级靶标轨道406中靠近定位的窗孔418中的垂直爪销416枢转的爪412落入初级靶标轨道404上靠近定位的近端定位凹槽420中。
套筒422包括中空轴(或者套管)423，其与圆柱形套节424靠近连接并具有靠近开口的远端428的侧窗孔426。圆柱形套节424具有在外部形成的指轮430，用于使侧窗孔426旋转。圆柱形套节424具有包围鸭嘴密封件434、弹性密封环436和密封保持器438的内部凹槽432，当轴423空置时提供流体密封并密封插入的导引器闭塞器440。
导引器440有利地包括多个具有相应零件的元件。中空轴442包括在侧向开口446和近端口448之间连通的流体腔444。中空轴442的纵向尺寸设置成当完全接合时能够将穿刺尖449伸出套筒442的远端。闭塞器指轮盖450包围近端口448并包括锁定零件452，该锁定零件包括可视角度指示器454，该指示器与套筒指轮430接合以确保侧向开口446与套筒422中的侧窗孔426对准。闭塞器密封盖456可在近侧接合在闭塞器指轮450中，从而关闭流体腔444。闭塞器密封盖456包括锁定零件458，该锁定零件包括与闭塞器指轮盖430上的可视角度指示器454对应的可视角度指示器460。
在组织穿刺过程中，通过具有容纳套筒422的圆柱形套节424的套筒套节462的套筒固定架460导引套筒422。套筒固定架460具有沿着次级靶标轨道406的顶部和底部导引凸缘466、468滑动的侧向套筒套节通道464，每个导引凸缘具有对准的带脊状凹槽的棘轮表面470，所述表面与各自的顶部和底部轨道锁定摇杆锁476、478上的各自的顶部和底部棘轮零件466、468相互作用，所述轨道锁定摇臂锁通过各自的顶部和底部锁销480、482接合在套筒固定架460的各个侧面中。棘轮零件472、474向近端倾斜，以便允许例如向远端运动。每个轨道锁定摇杆锁478、480的远端部分通过各自的轨道锁定压缩弹簧484、486向着远离套筒固定架460的方向偏置，将棘轮零件472、474偏压成与导引凸缘466、468的脊表面470接触。当次级靶标轨道406未相对初级靶标轨道404锁定时，同时压缩轨道锁定摇臂锁476、478允许套筒固定架460被向近端拉动，将任何支撑在其中的套筒422退出，直到套筒固定架460顺时针(从顶部观察)旋转爪412并由此接合到次级靶标轨道406，采用持续向近端的运动导致从其间除去。
在将次级靶标轨道406安装到第一位置中的初级靶标轨道404之前，套筒固定架460可有利地调节定位在次级靶标轨道406上，设定预期穿刺深度。特别是，深度引导件490由具有设置成能与导引凸缘466、468的顶部和底部接合的形状的侧向通道496的新月形深度指示器492形成。侧向通道496的顶部和底部向前倾斜的表面498设置成与次级靶标轨道406上的脊状棘轮表面470接合，允许通过从次级靶标轨道406的远端插入深度指示器492来装配。此后的摩擦接合进一步阻止了向近端的运动并强烈地对抗任何向远端的运动，特别是来自深度引导件490的深度导螺杆500的运动，当深度致动器杆505用于旋转并将深度导螺杆500纵向定位于其间时，该深度导螺杆的远端502在深度指示器492中的外侧孔504中旋转，其近端横向偏转。深度导螺杆500的中间部分容纳于在套筒固定架460中向着其侧向通道408的外侧形成的纵向通孔506中。对于粗深度调节而言，深度导螺杆500上的外部导引螺线507选择性接合套筒固定架460，直到顶部和底部粗调按钮508、510向内压缩到套筒固定架460中，压缩各自的顶部和底部粗调压缩弹簧512、514。每个粗调按钮508、510包括各自的垂直细长窗孔516、518，它们的内表面形成蜗轮部分，当通过松弛的粗调压缩螺杆512、514促动形成接合时，与深度导螺杆500上的外部导引螺线507接合。
上面提到的美国专利申请序列号为10/170,535、Hibner等人于2002年4月23日提交的题为“AN MRI COMPATIBLE BIOPSYDEVICE WITH DETACHABLE PROBE”的申请于2003年10月23日公开，公开号为US2003/0199753；题为“MRI BIOPSY DEVICE”、序列号为11/076,612、2005年3月10日提交的美国专利申请，两件申请的内容都通过引用而全文包含于本申请中，在这两件专利申请中描述了一种可拆卸探头(或者套筒)，其具有多种优点，例如在执行MRI手术，其中在再次成像过程中允许探头保持插入。在图1-5中，分离的套筒和闭塞器能力甚至提供了额外的临床灵活性。应当理解，零件的各种组合都可为专有应用或者偏好而选。常常需要在套筒中具有与活检装置中的样品采集侧窗孔对应的侧窗孔。例如，必须被插入到可疑病变中的具有开放末端的探头或者活检针可形成充满剩余造影剂的血肿，使其难以在该部位进行进一步的成像研究。另一方面，穿刺可疑病变可能造成轨迹转移的危险。此外，所述针或者探头的尖端可能难以相对于可疑病变成像从而难以将后者精确定位在实际的点上。
作为对照，在图6中，套筒602的侧窗孔600可设置在可疑病变旁边，使穿刺尖604不需要穿过可疑病变。将该侧窗孔602定位在MRI扫描部分中似乎更容易，原因在于侧窗孔600限定了一条线，其更易于允许沿着其具有几何参考的长度定向成像部分，这种几何参考显示组织可从什么方向吸入到用于活检的侧窗孔600中。但是，不能理想地定向或者穿过可形成套筒602的MRI相容性材料的部分仍可使侧窗孔600的精确和有利识别变得复杂。为了帮助这种识别，在套筒602引入过程中用闭塞器606辅助，通过大体上或者完全封闭侧窗孔600，使组织不悬垂到窗孔600中并阻碍插入和/或造成组织创伤。
在一些应用中，进一步需要在套筒602中具有远端开口608。闭塞器606从而有利地包括在套筒602中向远端伸出远端开口608的穿刺尖604。闭塞器606还具有侧槽(例如切口、坡口、独木舟式切槽)610，当闭塞器606完全插入其间时与套筒602中的侧窗孔600对准。由于径向不对称，这种侧槽610提供了用于定位侧窗孔600的快速采集和解析的参考。
在图7中，侧窗孔620在具有形成或者支撑穿刺尖624的封闭远端628的套筒622中形成。闭塞器622用于在引入过程中使悬垂到侧窗孔600中的组织成形，包括侧槽(例如切口、剖口、独木舟式切槽)630，当闭塞器626完全插入其间时与套筒622中的侧窗孔620对准。
在图8中，闭塞器646包括在图6的套筒602中伸出远端开口608的穿刺尖604。闭塞器646通过具有上部纵向部分649和下部纵向部分651形成独特横截面。上部纵向部分649形成为能够控制悬垂到侧窗孔600中的组织的形状，同时为MRI扫描部分形成易于定位的参考。
在图9中，图7的套筒622，其中关闭的远端628形成或者支撑穿刺尖624，显示具有其侧窗孔620，在引入期间由具有显示上部纵向部分649和下部纵向部分651的独特横截面的闭塞器656封闭。上部纵向部分649具有设计为使悬垂到侧窗孔600中的组织成形的横截面轮廓，同时为MRI扫描部分形成易于定位的参考。
在图10中，套筒702具有侧窗孔700和形成包围闭塞器706的非对称穿刺尖704的封闭远端708。闭塞器706具有由形成诸如如图11-12所示的X形的独特横截面的上部纵向部分709和下部纵向部分711形成的连续轮廓。作为替代，闭塞器706可具有独特横截面，例如与下部纵向半圆柱717连接的向上的纵向脊715。应当理解的是，在侧窗孔处悬垂的组织提供了MRI的返回图像，而在闭塞器的另外部分，套筒702和闭塞器706之间的气隙呈现相同的黑暗。
在图15中，闭塞器806包括靠近穿刺尖804的侧向切口810。与依赖重力作用、触诊或者真空辅助的组织悬垂不同，MRI可视插件807(例如含水凝胶，诸如JOHNSON & JOHNSON生产的KYJELLY)可有利地具有足够的硬度，以保持其位置并防止组织悬垂到套筒(在图15中未显示)的侧窗孔中。在图16中，作为侧向插入的替代，闭塞器826可包括向近端进入的标记物腔827，标记物插件829可通过该腔被插入到远端的穿刺尖824附近。
作为增加的MRI可视材料的替代，在图7中，闭塞器846包括与侧向切口850连通的真空腔848，以吸进足够的体液851，产生套筒(未显示)的侧窗孔的MRI可视图像。在图18中，闭塞器846采用真空辅助，通过真空腔848将组织悬垂到侧向切口850中，产生MRI可视图像。在图19中，闭塞器846还包括在侧向切口850的顶部上方滑动以采集MRI可视材料(例如含水流体、钆溶液等)857的薄护套855。
在图20中，闭塞器876包括实心管心针插件879，除了在实心管心针插件879中形成的侧向切口881上方之外，其大体上由圆柱形护套877包围。圆柱形护套877在远端与陶瓷非对称穿刺尖874连接。
在图21中，闭塞器899具有开口远端894和侧窗孔890，侧窗孔具有从在其中形成的标记物腔893向近端的真空辅助排气，允许标记物腔893填充体液，形成MRI可视材料。
在图22中，闭塞器906具有穿刺远尖端0904和侧窗孔0900，侧窗孔具有真空辅助排气，允许标记物腔903填充体液，形成MRI可视材料。
在图23中，闭塞器916具有封闭的钝远端914和含有MRI可视材料(例如钆溶液、水溶液)911的标记物腔918。MRI暗插头913(例如胶原、非铁金属、塑料)对应于套筒(在图23中未显示)的侧窗孔定位。MRI暗插头913包括纵向流体泄露通道915，允许MRI在标记物腔918内的侧窗孔的每一侧照亮待形成的图像。
在图24中，闭塞器926具有穿刺的远端924和含有MRI可视材料(例如钆溶液、水溶液)921的标记物腔928。MRI暗插头928(例如胶原、非铁金属、塑料)、923对应于套筒(在图24中未显示)的窗孔定位。MRI暗插头923包括纵向流体泄露通道925，允许MRI在标记物腔928内的侧窗孔的每一侧照亮待形成的图像。
在图25中，闭塞器936具有穿刺的远端934和含有MRI可视材料(例如钆溶液、水溶液)931的标记物腔938。侧窗孔930经在MRI暗插头(例如胶原、非铁金属、塑料)933中形成的流体泄露通道935与标记物腔938连通，否则封闭标记物腔938。
在图26-27中，示出了套筒和闭塞器的另外的示例性方案，其有利地增强定位可疑病变的能力，并在获取活检样品之前，通过在穿刺过程中形成可改变成与将采集样品的解除区域对应形状的封闭形状，确保其侧窗孔的正确设置，这种形状是可见的立体，以便易于识别，甚至当从图像部分的各个角度观察时都是如此。
该特征解决了依靠用于成像的探头的缺点。在成像区域具有金属物质可造成假象(局部模糊)，其可使关注的组织模糊，例如试图使用活检探头本身封闭套筒。当穿过中空套筒22的图像部分在分辨侧窗孔方面有困难时，在成像期间除去探头并仅仅依靠套筒会发生另一种成像挑战。通常，所选的MRI相容性材料给出了无MRI反射图像，例如穿过侧窗孔产生填充了空气空隙，因而不产生反射。
在图26-27中，MRI相容性活检系统1210包括套筒1222，其具有与MRI活检装置(在图26中未显示)的探头的探头侧窗孔的位置和尺寸对应的切口1202。此外，切口1202的深度在一些情况下可比探头侧窗孔更深，处于成像的目的在套筒1222上强调该位置。
闭塞器1224，在图26中显示处于其“关闭位置”，大体上封闭套筒1222的切口1202，可有利地由所述热塑性材料形成，具有在远端形成的经过套筒1222的开口远端1221延伸的陶瓷刀片部分1220。陶瓷材料在MRI环境下运行良好并保持锋利的边缘。随着切口被共轴插入的闭塞器1224关闭，套筒1222可插入到乳房组织中。
在图28-29中，所示闭塞器1224有利地包括如图28-29所示的纵向二分支设计，其中下部部分1223包括沿着其长度向下的燕尾形通道1225，其与从闭塞器1224的上部部分1229向下延伸的燕尾形翼片1227滑动接合。陶瓷刀状部分1220仅仅与下部部分1223连接。如图28中所示，上部部分1229可向近端运动，下部部分1223完全向远端插入套筒1222中，从而打开套筒1222的切口1202。由于闭塞器1224是实心的，在由MRI机获取3-4mm的图像部分过程中，闭塞器1222的下部部分1223填充在切口1202中，使其位置可以很容易被确定。这种两件式闭塞器1224有利地容纳具有复杂横截面形状的套筒腔，例如所示的椭圆形套筒1222(图27)。
在图30-31中，套筒1322包括向远端与其轴1319连接的整体形成的尖1320，所述轴1319限定了圆形切割器腔1321和位于下面的真空腔1323。在图32-33中，圆形闭塞器1324通常为插入到切割器腔1321中的杆状，但具有对应于套筒1322的切口1302形成的切口凹槽1325。至于圆形闭塞器1324在切割器腔1323中是可旋转的，切口凹槽1325可选择性的形成以打开套筒1322中的切口1302，或者围绕旋转的一半旋转以封闭切口1302。
在MRI图像扫描中产生的效果在图34-35中示出，其中用闭塞器1324选择性封闭套筒1322中的切口1302产生实像，但对切口1302定向在何处的指示很少。在图36-37中，随着闭塞器1324旋转以打开切口1302，很容易使切口1302被定向在何处清楚。
套筒可有利地由聚合材料形成，同质的或者混合的，坚固但具有薄壁，使整个外径不需要显著大于已知的活检探头，因而是无创的。强度和小横截面积将通过皮肤的开口尺寸最小化，因而通常避免了对用于封闭的缝合线的需要，减小了插入探头所需的力，并使穿刺的乳房组织到可疑病变的路径中的创伤最小化。强度和刚度有利地保持用于后续活检和通过其进行的其它手术的开放腔。另外，套筒有利地由对患者而言生物相容性和MRI相容性的材料形成。一般而言，材料因此不会形成可能使靠近套筒22的组织图像模糊的明显的人为成像假象。
可使用的聚合材料的例子包括，但不是完全穷尽列举：聚酰亚胺、聚醚亚胺(例如由GE PLASTICS生产的ULTEM树脂)，热塑性液晶聚合物(LCP)(例如由CELANESE AG生产的VECTRA)，聚苯醚甲酮(例如由VITREX生产的PEEKTM)，聚酰胺，聚碳酸酯(例如由BAYER POLYMERS生产的MAKROLON)，聚砜、聚醚砜，聚苯砜(例如由ROWLAND TECHNOLOGIES生产的RADEL)，以及尼龙和尼龙共聚物。
在图38中，穿刺元件(例如探头，多功能闭塞器)1700具有穿刺尖1702。见下面参照图22-80B的描述。侧向切口1704由下面的MRI可视标记物1706强调，并与可用于抽吸、止血、麻醉剂注射或者药物化合物和/或标记材料的腔1708连通。侧向切口1704的前后缘1710、1712是圆形的，以避免在插入和回缩过程中创伤组织。
在图39中，作为替代的穿刺元件1730具有一对在侧向切口1734侧面的MRI可视标记物1735、1736，其中对准的下部腔1738终止在侧向切口1734的下方，并经过孔1740与其连通。因此，可通过穿刺元件1730促进成像能力和流体注入/抽出。
在图40中，显示了图55-56的零件的组合，其中另一作为替代的穿刺元件1760具有一对在侧向切口1764侧面的MRI可视标记物1765、1766。标记物腔1768对准进入侧向切口1764的后缘1770，并且侧向切口1764的前缘1772倾斜以发射工具，例如插入的标记物展开工具1769。下部腔1771终止在侧向切口1764的下方并经过孔1775与其连通，在标记物展开期间用于吹气或者用于输送液体。
在图41中，具有与其纵向中心线对准的腔1802的芯针1800连通开口的远端1804，以展开针芯活检工具、标记工具、用于定位的导丝、消融装置等等。可成像标记物1806有利地围绕开口远端1804，帮助正确设置芯针1800。
在图42中，聚酰亚胺处理可用于形成这种材料，其中由溶液形成膜。标准作法是通过使来自线轴的金属丝经过聚酰亚胺包被液经过炉子到拉紧的线轴，包敷连续的金属丝。金属丝通常经过多种处理以形成包敷厚度。管道炉或者加热元件驱动溶剂脱离并引起聚酰亚胺部分交联。通常当需要的包敷厚度已经达到时发生完全交联。完全交联温度发生在比包敷期间使用的温度更高的温度下。
然后为了形成独立式聚酰亚胺管，除去金属丝。例如，包敷的金属丝的长度可随着从两端拖或者拉使其延伸而被切割，从而减小其外径直到与包敷分离，然后缩回金属丝。作为替代，容易化学蚀刻的材料可用作金属丝。例如，铜金属丝可由过硫酸盐络合溶液溶解，而留下独立式聚酰亚胺管。
此外，为了形成更复杂的横截面形状(图72A-72D)(例如椭圆形等)，聚酰亚胺管可在最终的交联加热步骤之前设置成一形状。另外，芯轴可经过聚酰亚胺管插入，进一步限定形状，特别是与压缩的外部形状接合，例如在序号为图44A-44C中所示的椭圆形，和在序号为图45A-45E所示的带缩腰的椭圆形。
在图46、47A-47B中，然后可形成在其远端形成侧窗孔和/或在其近端形成安装孔的后续工艺。例如，通过准分子或YAG激光器进行激光切割可形成所需的穿孔。而且，准分子激光器不仅可用于形成通孔，而且还可形成浮凸。浮凸可用来形成与嵌件注塑部件的足够的机械抵触，以在正常负载和拉伸过程中确保组件的整体性。全部穿孔可用于允许嵌件注塑部件、例如近端安装机构在变硬之前流经所述孔。
为了获得图43的管中的孔，可采用多种方法。例如，准分子或者YAG激光器可形成穿孔(图47A)。准分子激光器还可被程序化，从而不仅形成通孔，而且还形成浮凸。浮凸可代替用来与嵌件注塑部件形成足够的机械抵触以确保在正常加载和拉伸过程中(图47B)组件的整体性。作为另一个例子，可以接合冲压或者冲切工艺形成模件。所述部件可被切割、修边和冲压，接着以相同形式热处理。
形成的模件可以优选两面都坚硬的，并具有较高的导热性能。钢虽然坚硬，但导热性差。相反，铜和黄铜具有较高的导热性能，但比较柔软。硬化铝合金是用于形成模件的合适材料，其中钢插件用于形成冲压孔。
护套还可以由编织复合物形成。编织物的单根纤维可卷绕在最初的聚酰亚胺层上，然后密封在聚酰亚胺层中。编织物可以是MRI相容性陶瓷纤维，例如由3M生产的NEXTEL。
部分套筒和/或闭塞器可由这样的材料形成：这些材料根据它们在黑暗或者明亮条件下的可成像性而选取。当识别所述用于定位和诊断目的的工具时这会产生问题，在用于对乳房组织的最标准的MRI扫描顺序以检查可能的癌症条件下，已知的工程塑料看来是黑暗的或者具有较低的对比度。因此，当形成具有足够强度和MRI相容性套筒时，除了考虑上面的描述之外，代替或者增大对MRI而言是明亮的但不会形成明显的假象可能是有利的。除此之外或者作为替代，对MRI机而言显得明亮的塑封或者包敷或者插入材料可在结构“暗”材料上方形成。除此之外或者作为额外的替代，出于强度或者其它原因而选择的“暗”材料可用吸收增强的造影剂或者明亮的流体的材料塑封或者包敷或者插入。除此之外或者作为又一种替代，复合物或者多层材料可形成为具有一些层，其依据诸如强度特征而选择或者它们的特性对MRI机是可观察的其它特征而选择。
标记物带的特定模式，例如，可设置在套筒的侧窗孔的下面，或者围绕套筒靠近或远离侧窗孔的间隔环中。作为例子，Dy2O3或者Fe2O3可与墨汁混合然后印刷在部分套筒22上或者用于填充闭塞器24或者管心针上的凹槽。这种模式还可通过将Dy2O3或者Fe2O3作为填充物喷洒在热塑性塑料中，使其可通过反流或者热粘合施加到套筒24和/或闭塞器上。还有另一种方法是例如通过加载模制/模压的成分塑料(例如PEEK，ULTEM)和连接(例如将30％的Dy2O3注塑在PEEK中)将Dy2O3或者Fe2O3模件插入装置中。
作为再一种替代，材料区域能够用基于水的溶液和/或造影剂(例如钆螯合物)浸渍或者水合化，当成像时其因此而显得明亮。作为又一种替代，材料区域，例如浸渍或者水合化，可在使用前立即进行，或者所述材料可以预先水合化并无菌包装。
特别是，可选择对MRI而言显得明亮的一些聚合物，包括具有高乙醇或者羧酸官能团的合成水溶性聚合物。例如，纤维素衍生物包括羧甲基纤维素、乙基纤维素、羟乙基纤维素、羧甲基羟乙基纤维素、乙基羟乙基纤维素和甲基纤维素。作为另一个例子，丙烯酸盐包括聚丙烯酸盐和聚丙烯酰胺。作为又一种例子，其它合成材料包括聚乙烯醇(PVA)、聚乙烯基甲基醚，聚乙烯基吡咯烷酮(PVP)，聚环氧乙烷(PEO)。作为再一种例子，天然产物和衍生物包括玉米淀粉、明胶、糊精、藻酸盐、酪蛋白、胶原(例如血清蛋白等)和天然橡胶(例如苍耳酯、黄芪胶、刺梧桐树胶等)。作为又一另外的例子，生物聚合物包括双乳酸、聚酯-乙交酯共聚物(PLG)(即，作为交酯异构体(D，L，DL)(MP＝225-230℃)的例子)(polylacticacid，di-lactide-co-glycolide(PLG))，聚己内酯(MP＝60℃)，乳酸盐和葡萄糖酸盐，聚二氧杂环己酮、聚乙丙交酯(即缝合线材料)。
对MRI而言显得明亮的其它聚合物包括以硅树脂为基础的材料，例如用羟基(-OH)和羧酸基团改性的硅氧烷，例如硅树脂(即液体橡胶和纯胶胶料)。
当在MRI中使用聚合物材料成像而不产生过多假象时，在示例性方案中，将氧化镝(Dy2O3)或者赤铁矿(Fe2O3)作为填充剂分散在可热压成型(例如冲压、模制等)的热塑性载体中。当集成在装置例如套筒22或者闭塞器24中时，由此形成的标记物增加了装置在MRI(例如梯度回波EPI、反闪、实时真实FISP)下的可视性。具体而言，将Dy2O3(35％)分散在Rilsan聚酰亚胺(75％)ATOFINA Chemicals Inc.中。将这种混合物冲压到薄壁(即0.002英寸)管件中，该关键在使用反闪(Flash)时是完全可视的。此外，对于敏感装置(包括Dy2O3和Fe2O3)而言，反闪看起来可产生最佳可视性，EPI的可视性次之，实时真实FISP是不可视的。
其它对MRI机而言显得明亮的聚合物包括亲水聚合物和聚合泡沫，例如聚氨酯泡沫，当增加的亲水性封闭共聚物片段被加入到聚氨酯骨架中或者使用表面改性例如通过等离子氧化或者化学氧化作用时，聚氨酯泡沫可迅速吸收湿气。同样地，聚合物可形成泡沫，例如具有线性低密度聚乙烯的淀粉，膨化聚四氟乙烯(PTFE)，或者其它材料(例如聚酰亚胺，聚烯烃，聚苯乙烯、聚酯、尼龙、丙烯酸、丙烯酸盐、聚碳酸酯、蜜胺、聚氯乙烯、醋酸乙烯)。
作为执行部分，其中含溶液的液体混合或者水合到所述材料中，所述溶液包括以钆为基础的化合物，作为溶液中的T1增强，该溶液包括二亚乙基三胺五乙酸(DTPA)，钆特醇(GD-HP-D03A)(非离子)、钆双胺(GD-DTPA-BMA)(非离子)和GdDOTA(离子)。所述溶液还包括用于T2增强的含铁溶液，例如Feridex(超顺磁试剂)。
强调套筒22的侧窗孔102已经在上面讨论作为材料的选择或者可选择性关闭侧窗孔102的闭塞器的成形。上面还提到，套筒22的特定区域可被强调。关于后者，用在MRI成像下明亮的材料标记侧窗孔102可使用从市场上购买的造影剂来完成，以平衡现有资金需要和供应通道。所述造影剂的例子是钆(Gd+3)(例如BERLEX生产的MAGNEVIST(钆喷酸二甲葡胺注射剂)；铁(Fe+3)(例如FERIDEX IV(菲立磁注射液)；和锰(Mn+2)MnDPDP(例如AMERSHAM HEALTH生产的TESLASCANTMMangafodipir)。在水存在时聚合物基质可膨胀形成造影剂的包含的水化环境。这些聚合物是可渗水的，但对造影剂分子而言具有有限的渗透性。造影剂可以化学接合到基质上以降低或者限制它们迁移到基质之外。适于所述基质的聚合物的例子包括水凝胶、具有亲水屏障的丙烯酸氨基甲酸酯，乳胶漆/乳液，加载有亲水颗粒的包敷物，例如氧化硅粒子和aglomerates粒子。
闭塞器内的气孔可包括通风口和隔片。造影剂可使用经通风口进入的空气经过隔片注射。气孔中的亲水泡沫或者纤维素材料(例如棉花)可用于保持造影剂。作为替代，在该过程中造影螯合物可事先装载到亲水泡沫或者纤维素材料上并水化。
作为在MRI下明亮的材料的替代或者附加，可接合有源标记物带技术来照明一侧或者套筒中的远端侧窗孔。在不同应用中使用的有源照明在下列美国专利中公开：专利号为5,211,165；5,307,808；5,318,025；5,437,277；5,443,066；5,445,150；5,715,822；5,882,305和6,289,233。靠近取样侧窗孔形成线圈，例如具有沿着套筒22的长度形成的电连接的侧窗孔102。由于在聚酰亚胺上形成薄膜电路的技术和工艺的长足发展，对于形成所述线圈的基板而言，聚酰亚胺是特别好的材料选择。可使用另一层聚酰亚胺保护膜实现电绝缘。围绕与这些标记物带电连通的套筒22的基部的导电线圈可允许RF耦合到这些线圈并为患者提供RF绝缘。作为替代，专用集成电路和电源(例如电池，电容器)可集成在套筒22中，从而消除对外激励的需要。这些标记物带线圈可并联或者穿量或者各自被激发。作为另一种选择，两个线圈可串联设置但具有中间插头。
在一些应用中，可以预期包括热敏电阻器或者温差电偶，它们可被用于监测对于自动断路而言不可接受的升温(例如4℃)。作为再一种选择，光学转换器可包含在套筒中，使光纤可将信号传入和传出。
类似考虑对于套筒或者闭塞器的穿刺部分也适用；但是，穿刺组织的需要可导致其它选择。作为介绍，用作MRI安全医疗装置的金属元件必须是生物相容性的，并且不与在MRI成像过程中使用的强磁场相互作用。标准的300和400系列不锈钢在医疗装置设计中是普遍存在的。这些材料接合了抗腐蚀、生物相容性、硬度和抗张特性的特征。这些材料基本上是含铁的。300系列材料与磁场的相互作用比400系列材料小，但具有更低的硬度特性，这限制了它们在用于切割和/或穿刺组织的锋利边缘方面的应用。所有的300和400系列材料具有显著的铁离子浓度，这限制了它们在MRI成像应用方面的应用。
铁合金：至少有一种含铁的奥式体合金，甚至在切割形成操作之后，其保持了非磁性，Super Alloy Nitronic。其它相关材料包括Carpenter 22Cr-13Ni-5Mn，HPA 50，XM19。合金316也是相对非磁性的，但当其变硬时磁性增强。合金复合物如下：
  表1   钢组分范围(％)
  元素   Nitronic50   316L   理想
  碳   最大0.06   最大0.03   最大0.06
  锰   4-6   2.0   2-6
  磷   最大0.04   最大0.045   最大0.045
  硫   最大0.03   最大0.03   最大0.03
  硅   最大1.0   最大1.0   最大1.0
  铬   20.5-23.5   16-18   16-24
  镍   11.5-13.5   10-14   10-14
  钼   1.5-3   2-3   1-3
  铜
  钴   0.1-0.3   最大0.3
  钛
  铌   0.1-0.3   最大0.3
  铝
  钽
  钒   0.1-0.3   最大0.3
  钨
  硼
  氮   0.2-0.4   最大0.4
  铁   平衡   平衡   平衡
理想范围是落入该范围中的以铁为基础的合金需要到具有最小磁性特征。
钴合金：钴合金是良好的替代。这些合金很硬，而且不会与磁场强烈作用。所述合金的例子包括L-605和MP-35。钴合金优化为抗磨损、高温使用和/或抗腐蚀。对于最好的活检工具而言，抗磨损和抗腐蚀特征是最有益的。提供这些特性的基本合金成分是加入铬(US873,745)。钼和钨是突出的强化剂。碳的加入明显改善了抗磨损特性。加入到2.4％的碳导致碳化钙的形成。这些合金的例子是商品名为Stellite的合金。用于改进磨损的替代方法是加入钼和硅的组合物。这种合金的例子是商品名为Tribaloy的合金。这种合金已经成功的作为薄膜沉积。
发现镍的加入改善了高温行为。这种合金的例子是含有大约2.5％镍的Stellite 21。后一种合金例如X-40和L-605具有增加到大约10％的镍含量。一般而言，具有下列组成范围的合金对以Co为基础的高抗张强度高硬度材料是优选的：
  表2   组分范围(％)
  元素   L-605   MP-35   CCM   理想
  碳   0.05-0.15   最大0.025   最大0.1   最大2.4
  锰   1-2   最大0.15   最大1   0-2
  磷   最大0.03   最大0.015   最大0.2
  硫   最大0.03   最大0.01   最大0.05
  硅   最大0.4   最大0.15   最大1   0-2
  铬   19-21   19-21   26-30   19-35
  镍   9-11   33-37   最大1   0-40
  钼   9-11   5-7   0-15
  铜   0-1
  钴   平衡   平衡   平衡
  钛   最大1   0-2
  铌   0-1
  铝   0-1
  钽   0-1
  钒   0-1
  钨   14-16   0-20
  硼   0.01   0-0.05
  氮   最大0.25   最大0.25
  铁   最大3   最大1   最大0.75   最大5
以镍为基础的合金：镍-铬-钼合金是硬非磁金属合金的另一种途径。这种合金类别的一些元素具有大于5％铁(Inconel 600)，甚至不含铁的以镍为基础的合金可具有显著的磁性特征。合金的成分和进攻对其磁性和物理特性而言是关键的。一些合金例如Inconel 625具有超过95Rb的洛氏硬度。
  表3   组分范围(％)
元素   Inconel600   Inconel 600X750 M252 理想
  碳   0.08   0.1   0.1   最大2
  锰   0.5   1.0   1.0   0-2
  磷   最大0.2
  硫   最大0.05
  硅   0.25   0.5   0.7   0-2
  铬   15.5   15   19   10-20
  镍   76   72   53.5   平衡
  钼   10   0-15
  铜   0.25   0-1
  钴   1.0   10
  钛   2.5   2.5   0-2
  铌   0-1
  铝   0.7   0.75   0-2
  钽   0-1
  钒   0-1
  钨   0-2
  硼   0-0.05
  氮   最大0.25
  铁   8   7   2   最大10
合成途径：软金属，例如钛或者完全退火的316SS具有合适的磁性特征，但具有较差的硬度，因而具有较差的切割能力。这些材料可以在切割或者穿刺表面通过下列工艺局部硬化：(1)将硬材料边缘铜焊、焊接或者连接到软金属；(2)硬材料例如氮化钛蒸汽沉积(化学，真空等)；(3)离子束植入；(4)经激光或者摩擦加热局部加热/机械硬化；(5)或者上述方法的组合。
非金属材料选择：用于形成锋利的切割表面的其它非金属材料包括下列非晶态/陶瓷材料：(1)铝土；(2)氧化锆(包括氧化钇稳定的)；(3)硅石。单晶材料包括：(1)硅；(2)锗；(3)金刚石形式的碳；(4)兰宝石形式的铝；(5)红宝石。单晶切割边缘可以使用材料的单晶特性形成。优选蚀刻，例如在1，0，0硅片上的乙醇-KOH，可用于形成精确角度并由此形成锋利边缘。
穿刺元件的几何形状：刀的几何形状在优化施加到穿刺组织上的力方面是重要的。套管针的早期锥状设计近来已经被扁平刀设计所取代。尖和切割角度的理论追溯到1800’s的Augur bits。近年来，为了磨损组织，切割理论已经被研究，发展并细化。对于给定刀直径，当扭矩和穿刺力(医生推进套管针的量)固定时，支配这种优化的关键因素是尖端的几何形状。当其与组织层分离时，主要穿刺力(大约90％)由尖端控制。使用较小的穿刺力是有利的，因为这可引起较小的痛苦。在插入刀的同时在两个方向上都有120度的扭转运动。使刀推进的穿刺力没有被测量。可给出的假设是套管针以大约5lbs推动。切割刀是尖端的主要元件，其分离(切割)组织。在当前设计(图48)中，有30到35度的锐利锥角，同时扁平刀垂直于表面。本发明使用偏置的切割边缘和切割角度以及在中心处的副扁平锥尖角，研究了最优化尖端设计的优化，如图49A-49B所示。
定义：动态切割角(αdyn)：在通过切割边缘上的一点和垂直于穿过该点并与钻中心孔轴相交的水平线的平面中，位于倾斜面和包含切割边缘和切割速度向量两者的平面的法线之间的测定角度。切割速度向量是旋转切割速度向量和进刀速度向量的向量和。这是可在分离的组织层中使用的切割角度，具有在图50中所示的正向角和在图21中所示的负向角的几何形状。
如上所解释的，切割刀中任何给定点都具有两个速度向量。在当前设计中α＝0，因为刀垂直于切割边缘。假定刀的切割边缘被分成许多小的元素(N)。假定每个元素经历正交切割。计算切割边缘上任何瞬时和空间位置的动态倾角的方法可基于几何因子而建立。每个瞬时的扭矩可通过下列方程确定：
T [ total ] = Σ i = 1 N [ F p , F n ( f ( α d ( i ) , woc ( i ) ) × r ( i ) ) ]
其中αd(动态切割角)和r(i)(每个元素距钻孔轴的半径)对于切割边缘上的每个元素来说都是变化的。
当前设计和建议的设置之间的差别在于切割边缘(WOC)的宽度变化，切割角度可以更陡(范围从40到60度)。这是作为给定1in-lb扭矩和Xlbs刺入的切割相反的问题。在尖端得到更小的穿刺力是最好的几何形状。这可经过分析产生并在湿润实验中检验。
问题说明是：Ttotal＝常数-基于几何形状的减小Fn。
使用偏置切割边缘并使用40到60度的更具侵入性的切割角度，这是可能的。
切割边缘还具有多个刀状4以增力WOC。切割边缘不应是锋利的以避免刨沟。它可以具有5千半径来优化穿刺力。扁平刀可如图52A-52B中所示进一步优化。
在图53-57中，闭塞器3000将扁平刀3002接合到提供多功能腔3006的中空轴3004上。扁平刀3002连接在在两个远端倾斜的三角支架3010、3012之间形成的垂直槽3008中。中空轴3004的近端3014提供压力零件3006，将腔3006用于到靠近扁平刀3002的可成像侧槽3018的气体或者流体输送。在图53、55中，近端3014上的外接合零件包括靠近周向环形槽3022的周向突出的环3020。在图55中，通过相对的横侧到可成像侧槽3018的通风孔3024允许在套筒中平衡压力或者在套筒中使用真空腔(在图53-57中未显示)。在图56、57中，顶部导槽3026纵向向下穿过中空轴3004的近端部分3014，使套筒的接合可被锁定，将可成像侧槽3018与套筒中的侧窗孔对准。在图53、55中，可成像侧槽3018的圆形导引和牵引边缘3028、3030将组织创伤降到最低。作为替代，顶部导槽3026可允许视觉标引，使在穿刺过程中可确保可成像侧槽3026旋转不再与侧窗孔对准，防止组织进入成像侧槽3018中。此后，可成像侧槽可旋转成对准，用于成像确定和/或使用多功能腔3006。
在图58-60中，闭塞器3100将扁平刀3102接合到实心杆3104上。扁平刀3102连接在在两个远端倾斜的三角支架3110、3112之间形成的垂直槽3108中。靠近扁平刀3102的可成像侧槽3118与随后插入的活检装置(在图58-60中未显示)的侧窗孔对应定位。在图58-59中，可成像侧槽3118的圆形导引和牵引边缘3128、3130将组织创伤降到最低。特别参考图60，沟槽(“独木舟式”)凹槽3132在可成像侧槽3118中形成，以进一步强调可成像性。实心杆3104具有横截面卵形形状以对应包括具有更狭窄的低重心“导气管”形状的真空腔的探头。在图58-59中，纵向间隔设置的成像空腔，示为圆柱形垂直孔3140、3142、3144、3146，具有向靠近沟槽(独木舟式)凹槽减小的直径以进一步强调可成像侧槽3118。
在图61-64中，闭塞器3200将扁平刀3202接合到实心杆3204上。在图62中，扁平刀3202连接在两个远端倾斜的三角支架3210、3212之间形成的垂直槽3208中。转向图61-63，靠近扁平刀3202的可成像侧槽3218与随后插入的活检装置(在图61-64中未显示)的侧窗孔对应定位。在图61-62中，可成像侧槽3218的圆形导引和牵引边缘3228、3230将组织创伤降到最低。在图61-63中，沟槽(“独木舟式”)凹槽3232在可成像侧槽3218中形成，以进一步强调可成像性。实心杆3204具有椭圆形横截面以对应包括具有更狭窄的低重心“导气管”形状的真空腔的探头。在图61-62和64中，纵向间隔设置的成像空腔，示为圆柱形垂直狭条3240、3242、3244，具有向靠近沟槽(独木舟式)凹槽3232减小的直径以进一步强调可成像侧槽3218。每个狭条3240-3244分别经过远端和近端开口3246、3247与中空轴3208的顶部连通，以在通入捕获的空气的同时填充流体。特别参考图64，远端纵向狭条3240具有圆柱形横截面。中间纵向狭条3242具有圆柱形横截面，其与远端纵向狭条3240的下部部分对应。近端纵向狭条3244具有圆柱形横截面，其比其它纵向狭条3240、3244的侧向更窄，并具有相同的垂直高度，但略微从中间纵向狭条3242向上偏压。
在图65-68中，闭塞器3300将扁平刀3302接合到实心杆3304上。在图66中，扁平刀3302连接在在两个远端倾斜的三角支架3310、3312之间形成的垂直槽3308中。转向图65-67，靠近扁平刀3302的可成像侧槽3318与随后插入的活检装置(在图65-68中未显示)的侧窗孔对应定位。在图65-66中，可成像侧槽3318的圆形导引和牵引边缘3328、3330将组织创伤降到最低。在图65-67中，沟槽(“独木舟式”)凹槽3332在可成像侧槽3318中形成，以进一步强调可成像性。实心杆3304具有横截面椭圆形状以对应包括具有更狭窄的低重心“导气管”形状的真空腔的探头。在图65-66和68中，纵向间隔设置的成像空腔，示为圆柱形垂直狭条3340、3342、3344，具有向靠近沟槽(独木舟式)凹槽3332减小的直径以进一步强调可成像侧槽3318。每个狭条3340-3344分别经过远端和近端开口3346、3347与中空轴3308的顶部连通，以在通入捕获的空气的同时填充流体。特别参考图68，远端纵向狭条3340具有圆形横截面。中间纵向狭条3342具有圆柱形横截面垂直顶部，其与远端纵向狭条3340对准，并具有小于垂直高度但大于同一狭条的侧向宽度的直径。近端纵向狭条3344具有圆柱形横截面，其与远端纵向狭条3340的侧向宽度相同，并具有与中间纵向狭条3342对准的垂直底部。
在图69-75中，得到确认的是，对于用于MRI相容性锋利尖端的闭塞器轴而言，使用“暗”MRI相容性材料获得了足够的成像造影，所述锋利尖端嵌件注塑有高模数、热塑性合成树脂，例如PEEK，Radel，或者液晶聚合物(LCPs)例如VECTRA。位于合适位置的“明亮”粘弹性材料和/或水吸收/包含聚合物可定位套管(例如，活检装置的可拆卸探头或者其尺寸适于容纳活检装置的探头的套筒)的侧窗孔。
在图69中，具有30度角侧槽的闭塞器的左侧MRI图像显示，使用穿过侧槽的MRI部分获得了针对组织的足够造影。
在图70中，使用具有60度角的闭塞器的更加平缓过渡提供了类似结果。
在图71中，具有带独木舟式凹穴的侧槽的闭塞器的左侧MRI图像。
在图72中，在其中具有腔的图53的闭塞器左侧MRI图像填充有含水流体。
在图73中，具有腔的图53的闭塞器左侧MRI图像显示将水浸泡的胶原插头插入到腔中。
在图74中，图58的闭塞器左例MRI图像填充有含水凝胶(例如购自JOHNSON&JOHNSON的KYJELLY)。
在图75中，图63的闭塞器左侧MRI图像具有填充有钆的狭条。
理想的是具有一次性基准仪器，其有利地由用户填充并且甚至是一次性的。因此，诊断灵活性通过允许空置基准仪器具有更长的存放期、简化的灭菌工艺简化的储藏(例如更宽的温度范围)和减少的包装要求而得到增强。另外，终端用户可选择造影剂和其它可成像材料。
虽然已经通过描述多个实施方式对本发明进行了描述，虽然这些示例性实施方式已经描述得相当详细，但这并不是想限制本申请或者以任何方式将所附的权利要求的范围限制得如此详细。其它优点和修改对本领域技术人员来说是可以想到的。例如，其它成像模式可借助本发明的公开而想到。
作为另一个例子，可成像侧窗孔的各种形状可包含在靠近定位套管侧窗孔处的侧向表面。例如，代替圆柱形孔，具有其它横截面形状的孔也可包含(例如三角形、椭圆形、正方形、矩形、八角形等)。
作为另一例子，与使用非对称针的基于侧腔真空辅助的活检的活检装置不同，与本发明的各个方面一致的应用可包括具有由周向、共轴或者中间提供的真空阻抗的轴对称针。此外，除了轴对称MAMMOTOME侧腔外，闭塞器还可形成适于容纳圆柱形几何形状设计的形状。

Claims (24)

1、一种用于使用由磁共振成像(MRI)相容性材料制成的套管进行的最小程度侵入到人体乳房组织中的医疗手术的器械，所述套管包括靠近远端的横向开口和尺寸适于容纳针芯活检切割元件的纵腔，所述器械包括：
闭塞器，其包括由MRI相容性材料形成的轴，并且其尺寸适于代替针芯活检切割元件插入到所述套管中；和
MRI可成像的凹槽，其靠近套管的横向开口形成于闭塞器中，并在操作上构造为容纳MRI可视材料，以增强局部对比，增强识别。
2、如权利要求1所述的器械，其中，所述MRI可成像的凹槽包括在轮廓中的扁平切口。
3、如权利要求2所述的器械，其中，所述MRI可成像的凹槽还包括在扁平槽口中形成的槽沟。
4、如权利要求1所述的器械，还包括多个MRI可成像窗孔，其靠近MRI可成像凹槽纵向对准，每个MRI可成像窗孔与闭塞器的侧向表面连通。
5、如权利要求4所述的器械，其中，每个所述多个MRI可成像窗孔的形状与其它窗孔不同。
6、如权利要求4所述的器械，其中，所述多个MRI可成像窗孔包括多个孔。
7、如权利要求6所述的器械，其中，所述多个孔的每个都具有与其它孔不同的形状。
8、如权利要求6所述的器械，其中，所述多个MRI可成像窗孔包括多个圆柱形孔。
9、如权利要求4所述的器械，其中，所述多个MRI可成像窗孔包括多个狭条。
10、如权利要求9所述的器械，其中，所述多个狭条的每个都具有与其它狭条不同的形状。
11、如权利要求9所述的器械，其中，所述多个狭条中的每个包括具有在远端和近端开口之间连通的几何横截面的纵腔，所述开口连通闭塞器的侧向表面。
12、如权利要求4所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个填充含水材料。
13、如权利要求12所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个填充盐溶液。
14、如权利要求12所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个填充含水凝胶。
15、如权利要求4所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个填充亲水聚合物。
16、如权利要求4所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个填充粘弹性材料。
17、如权利要求4所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个包含具有比MRI相容性闭塞器材料短的T1驰豫时间的材料。
18、如权利要求4所述的器械，其中，在所述MRI可成像凹槽和多个MRI可成像窗孔中选择一个包含具有比MRI相容性闭塞器材料短的T2驰豫时间的材料。
19、如权利要求1所述的器械，其中，所述套管包括开口远端，所述闭塞器还包括在远端连接的穿刺尖。
20、如权利要求19所述的器械，其中，所述穿刺尖包括液晶聚合物。
21、如权利要求19所述的器械，其中，所述穿刺尖包括PEEK材料。
22、如权利要求19所述的器械，其中，所述穿刺尖包括嵌件注塑的陶瓷尖。
23、如权利要求1所述的器械，其中，所述闭塞器的轴包括液晶聚合物。
24、如权利要求1所述的器械，其中，所述闭塞器的轴包括PEEK材料。
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US9638770B2 (en) 2004-05-21 2017-05-02 Devicor Medical Products, Inc. MRI biopsy apparatus incorporating an imageable penetrating portion
US9795365B2 (en) 2004-05-21 2017-10-24 Devicor Medical Products, Inc. MRI biopsy apparatus incorporating a sleeve and multi-function obturator
CN105101872A (zh) * 2013-04-10 2015-11-25 株式会社东芝 Rf线圈以及磁共振成像装置
CN105101872B (zh) * 2013-04-10 2018-09-07 东芝医疗系统株式会社 Rf线圈以及磁共振成像装置
CN103876785A (zh) * 2014-03-05 2014-06-25 中国人民解放军第二军医大学 实体瘤微创活检及消融多功能针
CN103876785B (zh) * 2014-03-05 2015-09-30 中国人民解放军第二军医大学 实体瘤微创活检及消融多功能针
CN113017795A (zh) * 2016-05-25 2021-06-25 特里奥普希医疗股份有限公司 活检针设计
CN113796958A (zh) * 2020-06-12 2021-12-17 阿森松技术公司 使用由内向外跟踪的电磁场畸变校正
CN115337054A (zh) * 2022-10-19 2022-11-15 成都美创医疗科技股份有限公司 等离子辅助乳腺肿瘤旋切活检针

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US20050283069A1 (en) 2005-12-22
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