CN102481146B - 乳房的穿刺活检系统及其使用方法 - Google Patents

乳房的穿刺活检系统及其使用方法 Download PDF

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CN102481146B
CN102481146B CN201080038740.4A CN201080038740A CN102481146B CN 102481146 B CN102481146 B CN 102481146B CN 201080038740 A CN201080038740 A CN 201080038740A CN 102481146 B CN102481146 B CN 102481146B
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biopsy
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support arm
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K·德弗雷塔斯
I·萧
J·拉维奥拉
K·皮科特
N·A·戈卡纳特斯奥斯
A·凡特
C·路特
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    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/04—Positioning of patients; Tiltable beds or the like
    • A—HUMAN NECESSITIES
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
    • A61B90/17—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins for soft tissue, e.g. breast-holding devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy instruments
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
    • A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/25—User interfaces for surgical systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus for radiation diagnosis, e.g. combined with radiation therapy equipment
    • A61B6/50—Clinical applications
    • A61B6/502—Clinical applications involving diagnosis of breast, i.e. mammography

Abstract

提供一种用于安装在X射线系统上的倾斜的穿刺活检组件。由于活检针相对于所述检测器和所述X射线源中的至少一者呈角度，所以可以在活检过程中实施X射线成像，而不受所述活检装置的干扰。成角度的活检针还允许以改进的方式接近患者的腋下和胸壁。本发明的立体定位活检装置可以与任意X射线系统(垂直的或倾斜的)相连，所述X射线系统包括但不限于乳房X射线成像系统、层析X射线照相组合系统和乳房X射线成像系统/层析X射线照相组合系统的结合。所述系统灵活地支持使用任意图像捕捉模式(即，定位、二维乳房X射线照片、三维重建图形)，以观测目标和/或确定目标。利用这种布置，提供与多种不同的X射线成像平台一起使用的、具有扩大的患者覆盖范围的穿刺活检组件。

Description

乳房的穿刺活检系统及其使用方法
相关申请
根据美国法典第35部分1.119(e)(35U.S.C. 1.119(e))，本申请要求申请日为2009年10月8日、临时申请序列号为61/249,772的美国临时专利申请的优先权，所述临时申请以引用的方式结合于此。
背景技术
乳房X线照相术(mammography)是得到很好确认的乳房成像的方法，可用于乳腺癌的筛检和诊断。优选地，每年在年龄超过40或那些具有乳腺癌风险基因的女性成员人群中筛检乳房X射线照片。如果在筛检乳房X射线图像时识别出包块(mass)或钙化(calcification)(可疑区域(region ofinterest))，则患者可以要求进一步诊断。这种诊断可能包括对可疑区域活检和分析离体组织。
历史上，在乳房活检时，已经使用了各种成像方法(imaging modality)。所述成像方法包括超声波成像、X射线成像和磁共振成像。通常，实施乳房活检包括将患者定位、利用成像设备观测可疑区域、设定该区域的目标和从目标区域取出细胞或组织。可以通过多种方式提取细胞或组织，所述多种方法包括通过开放手术(open surgery)、细针抽吸(fine needle aspiration)、芯针活检(core needle biopsy)或真空辅助活检(vacuum assisted biopsy)。开放手术(最具侵入性的方式)，通常由放射科医师在观测可疑区域的过程中在乳房内放置金属丝来实现，其中该金属丝延伸至待切除的区域。然后将患者转到外科，并且利用金属丝定位可疑区域来取出组织。
细针抽吸、芯针活检和真空辅助活检的侵入性比开放手术低，允许无需通过开放手术获得细胞和组织。上述方法均是穿刺活检，由于针的尺寸不同，因此对应的活检样本的尺寸(和数量)也有差别。在每个方法中，患者都被定位、可疑区域被观测、活检装置的针进入可疑区域的目标位置，并且提取组织。细针抽吸装置和芯针活检装置通常提取一个组织样品，并且可以利用成像方法(例如超声波)监视它们进入目标。真空辅助活检装置通常具有较大的针，并且能够通过多芯提取(extract multiple cores)。
因为需要以三维图形的方式观测并确定目标区域，因而立体定位模式的X射线成像通常用于乳房活检。立体定位活检利用在至少两个平面拍摄的X射线图像获得尺寸信息。然后处理X射线图像，以利用视差原理(principal ofparallax)在三维空间内定位可疑部的目标区域，以确定目标区域的深度(或Z方向尺寸)。
申请日为2008年2月21日并以引用的方式结合于此的美国专利申请2008/0045833描述了利用层析X射线照相组合(tomosynthesis)在乳房活检时进行病灶定位的系统和方法。层析X射线照相组合(tomo)是实施三维(3D)乳房X射线成像的方法。层析X射线照相组合产生了穿过受压乳房的多个横截面层片(slice)的图像，并且X射线照相组合也用于辨别乳房病理。层析X射线照相组合的一个优点在于，影像是三维的，因此一旦在图像中辨别了可疑区域，就可以从例如，层片图像中的X、Y坐标和从图像层片深度位置给出的Z(或深度)坐标计算或推测出该可疑区域在乳房中准确的三维坐标。层析X射线照相组合的另一个优点在于能够通过在乳房中不同高度处的目标图像的抑制(suppression of image)而提供高的目标对比度(contrastvisibility)。由于X射线照相组合的优越的对比度，有希望将在层析X射线照相组合的图像中看到利用标准的乳房X射线成像技术、立体定位装置、超声波或者甚至是MRI(核磁共振)所无法看到的病理。出于上述原因，需要发展利用能够使用层析X射线照相组合的自然三维定位性能的层析X射线照相组合系统的定位方法。
发明内容
根据本发明的一个方面，提供一种用于安装在X射线成像系统的X射线源和检测器之间的穿刺活检组件。立体定位组件包括用于在偏离所述检测器所限定的平面一定角度的位置支撑活检装置的安装臂。在一些实施方式中，所述活检组件还可以包括侧边臂，该侧边臂允许从侧向接近乳房。立体穿刺活检组件包括用于在活检切除组织的过程中将所述活检装置机动引导至目标位置的引导模块。由于所述活检针相对于所述检测器呈角度设置，可以在活检过程中实施X射线成像，而不受所述活检装置干扰。此外，成角度设置的活检针允许以改进的方式接近患者的腋下和胸壁。
在一个实施方式中，所述穿刺活检组件包括电机或等同机构，使得所述活检装置能够朝向被识别的活检目标位置自动前进。所述系统优选地还包括使得所述装置手动前进的机构。所述系统允许用户限定沿活检路径到目标的停止位置，以在自动控制和手动控制之间转换。
在一个实施方式中，所述穿刺活检组件可以包括控制模块，该控制模块安装在所述穿刺活检组件上，所述控制模块使得医务人员能够控制所述装置朝向目标自动移动，而无需离开患者。一些实施方式中的所述控制模块可以显示与所述活检过程相关的信息，例如，所述针和所述目标的相对位置。所述控制模块还可以为用户提供可见或可听的警示，例如，警告所述针靠近所述胸壁、所述乳房平台或其他不合需要的位置。在一个实施方式中，所述控制模块的控制按钮布置为防止所述活检装置非故意地前进。
本发明的所述立体定位活检装置可以与任意X射线系统(垂直的或倾斜的)相连，所述X射线系统包括但不限于乳房X射线成像系统、层析X射线照相组合系统和乳房X射线成像系统/层析X射线照相组合系统的结合。所述系统灵活地支持使用任意图像捕捉模式(即，定位、二维乳房X射线照片、三维重建图形)和用于观测目标和/或定位目标的二维图像数据或三维图像数据的任意结合。利用这种布置，提供与多种不同的X射线成像平台一起使用的、具有扩大的患者覆盖范围的穿刺活检组件。
尤其是，这种组件可以容易地集成到层析X射线照相组合系统中。与所述穿刺活检组件一起使用，通过在所需的立体定位角度处捕捉层析X射线照相组合投影图像，这种层析X射线照相组合系统可以容易地适于提供自动立体定位图像捕捉。由于层析X射线照相组合投影图像基本上在比传统乳房X射线成像系统较低的剂量下获得，因而这种系统具有降低患者暴露的额外的优势，并且因此，可以在较少的剂量下获得(用于观测或确定目标的)三维立体定位图形信息。本发明的这些和其他优点将在下文中作更详细地描述。
附图说明
图1说明了可以优利地与本发明的穿刺活检组件结合的X射线成像系统；
图2说明了具有已安装的活检装置的根据本发明的穿刺活检组件的一种实施方式；
图3A和图3B说明了X射线系统的安装有根据本发明的穿刺活检组件的部分，并且用于说明活检装置的角倾斜如何在X射线成像过程中降低干扰；
图4是本发明的穿刺活检组件的侧视图，更详细地说明了所述活检装置支撑臂的角倾斜；
图5是本发明的穿刺活检组件的俯视图；
图6A至图6C图证了优利地与图2中的穿刺活检组件一起使用的挤压桨；
图7是可以与本发明的穿刺活检组件一起使用的挤压桨的一侧；
图8说明了在采集工作站截面处的图像捕捉，其中通过可穿过射线的挤压桨，整个检测器都是可见的；
图9是说明可以在利用本发明的穿刺活检组件的活检过程中实施的示例性步骤的流程图；
图10说明了图2中的穿刺活检组件的控制单元的用户界面的示例性视图；
图11说明了支持并与图2中的穿刺活检组件相关的、包括功能性模块和显示器的采集工作站的用户界面的示例性视图；
图12A至图12C说明了穿刺活检组件的一种实施方式的视图，该穿刺活检组件的具有侧活检臂附件。
具体实施方式
乳房层析X射线照相组合系统通常包括X射线源和X射线检测器，所述X射线源安装在门架(gantry)的旋转臂上，X射线检测器通常定位为当所述X射线检测器在零位(zero position)时，该X射线检测器大致垂直于所述X射线源。在获取层析X射线照相组合的图像时，X射线源在受限的角度范围内转动。在X射线源的路径中的多点处，所述X射线源是激活的，并且可以通过检测器捕捉图像。在每个点处捕捉的每个图像都被称为投影图(projection image)。利用计算机程序根据投影图重建三维图形(threedimensional volume)，该三维图形用于病灶检出(lesion detection)。图1中展示了可以适于与本发明相结合的X射线成像系统的一个实施例，该X射线成像系统可以进行乳房X射线成像和层析X射线照相组合成像。
所示的乳房X射线成像/层析X射线照相组合成像系统包括采集工作站(AWS)4和支撑X射线成像组件2的门架1。这种乳房X射线成像/层析X射线照相组合成像系统现在可以从名为“Selenia Dimensions”的厂商的普通代理商处获得，并且仅表示一个安装有本发明的穿刺活检组件10的X射线系统。门架1支撑可以沿该门架向上或向下移动以选择高度的C形臂，该C形臂由操作系统的医学专家(health professional)控制的电机驱动。C形臂的上端设置有X射线管2a，下端设置有乳房托盘2b。该乳房托盘2b覆盖平面X射线图像接收器2c，聚焦防散射格栅(focused anti-scatter grid)2d将平面X射线图像接收器2c与乳房托盘2b隔开(聚焦防散射格栅2d可以是可伸缩式的，从而能够从乳房托盘2b和平面X射线图像接收器2c之间的空间内移除)。C形臂还设置有挤压桨(compression paddle)2e，该挤压桨2e位于X射线源2a和乳房托盘2b之间，并且挤压桨2e被机动化，以从乳房托盘2b移开，因此患者的乳房可以放置在乳房托盘2b和挤压桨2e之间，并且挤压桨2e可以靠近乳房托盘2b，从而可以挤压并固定患者的乳房。挤压桨2e的移动被机动化，并且由医学专家控制。可以将不同尺寸和不同结构的挤压桨2e安装在所述门架上，以适应不同尺寸的乳房或适应成像需求(即，用于筛选或诊断)。此外，由于在目前由普通代理商所提供的Selina系统中，乳房不位于乳房托盘2b的中心，所以医学专家可以沿乳房托盘2b的宽度将挤压桨2e移动至使得该挤压桨2e与乳房的位置相匹配的位置。所述系统还包括其他部件，例如，包括控制站4、控制器和影像处理设备，控制站4包括界面装置(例如，键盘4a和轨迹球4b、显示屏4c)。
根据本发明一个方面，穿刺活检组件10可以容易地安装在成像系统2的X射线源和X射线检测器之间。与之前的穿刺活检组件不同，本发明的穿刺活检组件利用X射线系统中所有的现有部件，包括挤压装置和X射线检测器。因此，可以理解的是，所述穿刺活检组件是低成本方案，使得多种现有的X射线成像平台都可以具有竖直(upright)穿刺活检的能力。
图2更详细地说明了穿刺活检组件10。支撑架21在手柄23a和手柄23b之间延伸，手柄23a和手柄23b便于搬运穿刺活检组件10。安装在支撑架21上的引导模块19包括用于控制活检装置15的移动的部件。例如，所述活检装置可以是由豪洛捷公司(Hologic Inc)生产并销售的EvivaTM真空辅助活检装置。固定支撑臂17从所述引导模块延伸至连接件31。在一个实施方式中，连接件31以固定的角度将角支撑臂12连接至固定支撑臂17。此处，包括用于改变所述角支撑臂和所述固定支撑臂之间的偏移角的调整机构的可选实施方式可作为等同替换。机架安装件(holster mount)35可移动地与所述支撑臂相连。可以机械地控制(即，通过所述引导模块和相关联的电机)线性移动，并且/或者可以利用指轮旋钮(thumbwheel knob)33a和33b中的一个或两个手动地控制所述线性移动。机架安装件35包括适于接收活检机架(biopsy holster)13的连接机构(attachment mechanism)36。活检装置15安装在活检机架13内。针支撑件11可以优选地与所述机架安装件相连，以使所述针稳定。控制模块25可以通过夹具36安装在手柄23b或手柄23a上。在各种实施方式中，每个手柄可以包括一个或多个电连接件，该电连接件允许被夹紧的控制模块25和引导模块19之间通讯，并且医学专家可以根据偏好将所述控制模块移动至任意一个手柄。控制模块25包括用户界面，使得医学专家无需离开患者就可以控制活检过程。所述控制模块包括用于显示有关活检的状态或其他信息的显示器28和用于在活检过程中控制所述活检装置的移动的一个或多个按钮27。
图3A和图3B说明了安装在X射线成像系统的门架上的穿刺活检组件10。所述穿刺活检组件的多种实施方式可以与竖直或倾斜的成像系统一起使用，出于本申请的目的，描述了与竖直的乳房层析X射线照相组合成像系统(例如由豪洛捷公司提供的DimensionTM乳房层析X射线照相组合成像系统)一起使用的实施方式。一种示例性的层析X射线照相组合成像系统可以包括支撑锥形束X射线源或其他X射线源的管头32和装有(encase)X射线检测器的挤压平台30。管头32可旋转地安装在门架(未示出)上，以使所述管头能够沿大致如图3B中的点划线41所表示的角度轨迹旋转。
在一种实施方式中，穿刺活检组件10包括夹具、钩或其他用于将所述穿刺活检组件安装在所述层析X射线照相组合成像系统的门架上的连接工具。优选地，所述夹具与所述门架的支撑其他附加的装置(例如，护面罩等)的特征相配合，但是这种重新利用不是必要条件。
在图3A和图3B的示例中，机架13与位于固定角臂12上的机架安装件相连，并且固定角臂12以偏离支撑臂17的垂直方向10度的角度固定地安装在支撑臂17上，但是，容易理解的是，偏离角度可以改变，并且主要是设计选择的问题。调整固定角臂12的角度(并因此调整活检装置15的角度)允许所述活检装置给进到位于活检目标区域(大致用目标区域50表示)内的预定位置而所述活检装置和机架不会在X射线图像中引入伪影(artifact)。如图3B所示，锥形束X射线源将延伸至目标区域50内，但是活检装置15不会落入锥形束内。应当注意的是，虽然公开了10度的固定角，但本发明不限于任何特定的固定角，并且应当理解的是，所选择的固定角可以根据成像系统和组织移除工具的具体几何形状而不同。在最广的意义中，本发明包括调整活检针的角度以限制在X射线成像时由所述活检针导致的引入视觉伪像的想法。
图4是本发明的穿刺活检组件的示例性实施方式的侧视图。在图4中，线A所在的平面垂直于X射线检测器30所在的平面。线B说明了所述活检装置的角位移，并且，因此所述活检装置以角度θ偏离竖直方向。因此，所述活检装置将不干扰活检成像。
图4中还更详细地示出了活检组件10的示例性的连接机构50a和连接机构50b。连接机构50a和连接机构50b适于与所述门架的互补特征相配合。此处，其他类型的连接机构(包括闩锁、钩、槽等)可以很好地作为等同替换。
图5是所述穿刺活检组件的示例性实施方式的俯视图，仅展示了便于引用而标示的部分部件。当从这一视图观察所述穿刺活检组件时，很容易看到针尖的位移N，该位移N由所述穿刺装置的角倾斜所导致。这一视图最佳地说明了所述活检装置到乳房活检区域(例如腋窝组织和胸壁附近的组织)的能力，以前，利用现有技术的立体定位装置是难以到达所述乳房活检区域的。
图6A到图6C说明了可以与本发明一起使用的各种挤压桨。现有技术中，通常利用不透射线的材料制作穿刺活检挤压桨，该挤压桨具有用于接受活检针的孔。与现有技术相比不同的是，挤压桨62A-62C优选地为可透过射线的。槽64a和槽64b设置为使得所述挤压桨能够与所述X射线成像系统的所述挤压装置可拆卸地相连，允许所述挤压桨与用于筛检乳腺癌的乳房X射线成像/层析X射线照相组合桨(mammography/tomosynthesis paddle)容易地交换。如图6B和图6C所示，活检挤压桨可以制造成不同的尺寸，以用于不同尺寸的乳房。每个活检挤压桨上设置有孔66。该孔使得目标乳房部分暴露。如图7所示，挤压桨62a的环绕孔66的部分68成型为增加待活检的乳房部分的挤压力，从而使被活检的区域更稳定。
使用可透过射线的乳房挤压桨的一个优势在于，允许看到整个检测器；在现有技术的穿刺活检布置中，只有检测器的与目标位置相关联的部分是可见的。这是足够的，因为现有技术仅在位于挤压桨的孔的正下方的组织部分上实施活检。然而，本发明的倾斜的针增加了可用于活检的组织的量，所述倾斜的针超过了挤压桨的开孔的边界，如图5中所示，所述倾斜的针实际能达到N处。因此，如上所述，在活检时，可以更容易地切除腋下组织以及靠近胸壁的组织。
图8说明了乳房与可透过射线的活检挤压桨(例如，图6A-图6C和图7中所示的活检挤压桨)一起拍摄的二维图像。如图8所示，所述可透过射线的挤压桨的一个优势在于，在采集工作站界面处可以看到整个检测器图像；放射科医师不再受他们所获得的信息的限制。因此，放射科医师可以看到病灶的延伸超过挤压桨孔66的部分80。可以利用本发明的倾斜的活检针组件到达乳房的这部分，以确保为了正确诊断而到达所有组织。
如上所述的示例性穿刺活检组件通常可以按照如下所述的方式使用。将确定为活检对象的患者定位在X射线成像系统上。在步骤91中，活检挤压桨朝向挤压平台向下移动，挤压患者的乳房，并且在步骤92中，开始观测病灶的过程。如上简要地所述，根据X射线成像系统的性能，可以利用定位像(scout image)、乳房X射线成像(mammogram)、所获取的立体定位像(stereotactic image)、所获取的层析X射线照相组合投影图像、层析X射线照相组合重构图像(tomosynthesis projection image)或者其任意组合来实施对病灶的观测。在一种实施方式中，具有层析X射线照相组合功能的X射线成像系统可以适于包括“立体定位模式(stereotactic mode)”，当选择该“立体定位模式”时，导致X射线成像系统自动取得典型的+/-15度立体定位像，并在该立体定位像上实施适当的成像处理，以导出立体定位图像(stereotacticvolume)。这种实施方式的一个优势在于，可以降低患者在层析X射线成像系统中的暴露，其中层析X射线照相组合在获取投影图像时使用较低剂量。
一旦观测到病灶，在步骤93中确定病灶目标。确定病灶目标包括利用图像数据确定病灶的坐标，并且利用本领域技术人员所公知的转换技术将图像的笛卡尔坐标系统的坐标转换成倾斜的活检组件的角坐标系统。根据本发明的一个方面，不同的图像或图像的组合，可以用于观测病灶，而不是用于确定病灶目标。例如，假设首先使用定位像确保病人就位，并且使用一对立体定位像观测病灶。如果在定位像中而不是在两个立体定位像中都发现病灶，则可以结合使用所述定位像和其中定位有病灶的立体定位像，以导出目标位置信息。因此，如上，根据X射线成像系统的性能，可以利用定位像、乳房X射线成像、所获取的立体定位像、所获取的层析X射线照相组合投影图像、层析X射线照相组合重构图像或者其任意组合导出病灶目标坐标。
在步骤94中，一旦导出目标坐标，医学专家能够通过按下移动活检针所需的控制按钮来开始活检过程。图10说明了控制单元25的示例性显示器和按钮。所述控制单元包括用于显示与活检相关的信息的显示器28，所述与活检相关的信息包括例如关于针的尺寸的信息、到平台和挤压桨的距离、针的坐标、目标坐标、与目标接近的信息以及其他相关信息。控制面板可以为用户提供其他有帮助的信息，例如当针距离乳房平台、胸壁或皮肤线(skinline)过近时的警示信号。如上所述，该警示信号可以是色标(color coded)，或者可以提供其他在不合需要的情况下的可见或可听的信号。
如上所述，在一种实施方式中，所述控制单元还包括按钮(包括按钮27)，该按钮定位并设置为在阻止意外启动的同时允许单手启动所述活检组件。在一个实施方式中，设置了一对控制按钮，其中一个控制按钮设置在所述控制面板的前面上，另一个控制按钮设置在所述控制面板的背面上。只能通过同时按下两个控制按钮来启动所述活检组件的移动。此处，其他用于确认操作者意图的机构可以用作替代，而不影响本发明的范围。
根据本发明的一个方面，可以在活检路径(biopsy path)中引入机械止挡件，以沿所述活检路径在特定点处止挡针的自动移动。例如，合乎需要的是，当所述针在目标的所需范围内时，可以切换到手动控制针的移动，即通过旋钮33a或旋钮33b来手动控制针的移动。或者，合乎需要的是，可以提供释放制动器(release brake)，以减缓所述针插入所述乳房中。根据一种实施方式，所述机械止挡件的数量和位置是可编程功能(programmablefunction)，所述机械止挡件可以根据系统的用户的个人偏好定制。简单地说，可以想象很多用于所述针机械推进的方法，包括齿轮推进、活塞推进等。
现在回到图9，在步骤95中，一旦所述针进入目标坐标，可以获取图像以确认所述针实际上位于所述病灶处。由于所述活检针位于X射线成像系统的视野外，因此可以不受干扰而获得图像。在步骤96中，当确认所述针位于目标处时，可以切除组织，并且完成活检。虽然在流程图中没有明确地示出，但是可以重复步骤95和步骤96，以确认对整个病灶的切除活检。
相应地，穿刺活检组件如上所示、所述。根据本发明的另一个方面，通过具有穿刺活检控制性能，采集工作站的用户界面优利地得以提高。图11中示出了可以添加至采集工作站以与所述穿刺活检组件一起使用的用户界面特征。用户界面包括菜单和/或控制按钮或图标，使得放射科医师能够控制在活检过程中收集的信息的显示和输出。目标工具110允许用户仔细观察、修改和删除目标信息。图像源选择器(image source selector)120(包括立体定位、层析X射线照相组合、定位、乳房X射线成像等)允许放射科医师选择用于观察或确定目标的图像。图像观测选择器130允许放射科医师快速拖动并浏览在活检过程中获得的任意图像。任意图像可以被拖动至图像窗口150。采集工作站上还可以包括与活检相关的其他信息，例如活检装置的类型、目标和挤压板/平台之间的相对距离等。应当注意的是，虽然图11的示意图中已经展示了按钮和图标的特殊布置，但是本发明并不限于这种信息的任何特殊形式，并且此处，下拉菜单、超链接、图标、按钮和窗口的其他形式可以考虑作为等同方式。
虽然上述实施方式描述和说明了一种穿刺活检组件，该穿刺活检组件用于在针位于乳房的大致呈头尾方向(cranial caudal orientation)获得核心(core)，根据本发明的一个方面，通过作为附件的侧(lateral)活检臂可以从侧面进入乳房。实施侧面活检的能力对于乳房较瘦的患者尤为重要，因为挤压会使乳房的厚度减小到使得位于活检针的末端的组织切除口不能完全插入到组织中的程度。图12A至图12C说明了本发明的穿刺活检组件的一种实施方式的各种视图，该实施方式增加了侧活检臂200。图12A是扩增后的组件的主视图，图12B是所述扩增后的组件的立体图，而图12C是所述扩增后的组件的侧视图。所述侧活检臂沿大致平行于所述检测器的直线支撑所述活检针，从而允许侧向切除乳房组织。在图12A至图12C的实施方式中，侧活检臂包括机架安装板210和指轮220。指轮220的转动导致所述活检针沿图12A中所示的X方向的手动移动(manual translation)。虽然示出了在X平面内的手动移动，应当理解的是，可以通过从引导模块19到机架板210的扩展控制来实现机动移动(motorized translation)。
总是以所述活检针位于头尾方向为假设来定位病灶，病灶限定了所述活检针应该沿X、Y、Z方向移动的距离。根据本发明的一个方面，当侧活检臂与机架安装件13相连时，位于所述机架安装件上的电连接件与位于侧活检臂上的连接器一起安装，以使得引导模块19能够合适地调整引导坐标系统，从而正确定位病灶。
相应地，已将展示并描述了具有很多优点的倾斜的穿刺活检组件。因为所述活检针相对于检测器和X射线源中的至少一个呈角度设置，所以可以在活检过程中实施X射线成像而不被所述活检装置干扰。此外，呈角度设置的活检针允许以改进的方式接近患者的腋下和胸壁。本发明的立体定位成像活检装置可以与任意X射线系统(垂直的或倾斜的)相连，所述X射线系统包括但不限于乳房X射线成像系统、层析X射线照相组合系统和乳房X射线成像系统/层析X射线照相组合系统的结合。所述系统灵活地支持用于观测目标和/或目标定位的图像捕捉(即，定位、二维乳房X射线照片、三维重建图形)的任意模式的使用。利用这种布置，提供与多种不同的X射线成像平台一起使用的穿刺活检组件，该穿刺活检组件具有扩大的患者覆盖范围(patient coverage)。
通过描述示例性的实施方式，能够理解的是，上述实施例仅是说明性的，并且其他实施例也包涵在附加权利要求的范围内。

Claims (18)

1.一种穿刺活检组件，该穿刺活检组件用于在能够进行乳房X射线成像和层析X射线照相组合成像的X射线成像系统的成像源和图像检测器之间定位，所述穿刺活检组件包括：
支撑结构，该支撑结构能够与X射线成像系统连接，且位于该X射线成像系统的成像源和图像检测器之间；
固定支撑臂，该固定支撑臂与所述支撑结构相连；
活检装置，该活检装置与角支撑臂相连，该角支撑臂以偏离由所述图像检测器限定的平面的角度与所述固定支撑臂相连，以使该活检装置不会落入该成像源的X射线束内；
引导模块，该引导模块连接在所述支撑结构和所述固定支撑臂之间，所述引导模块包括用于控制一机架安装件沿所述角支撑臂的机动移动的部件，所述机架安装件与所述角支撑臂连接；以及
用于控制所述引导模块的控制单元。
2.根据权利要求1所述的穿刺活检组件，该穿刺活检组件还包括所述机架安装件，该机架安装件可移动地与所述角支撑臂相连，所述机架安装件适于沿所述角支撑臂支撑穿刺活检机架，该穿刺活检组件还包括用于手动地使所述机架安装件沿所述角支撑臂前进的机构。
3.根据权利要求1所述的穿刺活检组件，该穿刺活检组件包括调整机构，该调整机构用于调整所述固定支撑臂和所述角支撑臂之间的角度。
4.根据权利要求1所述的穿刺活检组件，其中，所述控制单元包括用于显示与所述穿刺活检组件相关的信息的显示器。
5.根据权利要求4所述的穿刺活检组件，其中，显示的信息包括与所述穿刺活检组件相关的警报信息。
6.根据权利要求4所述的穿刺活检组件，其中，所述信息与连接于所述角支撑臂的所述活检装置的位置相关。
7.根据权利要求4所述的穿刺活检组件，其中，所述信息包括与连接于所述角支撑臂的所述活检装置的类型相关的信息。
8.根据权利要求1所述的穿刺活检组件，该穿刺活检组件还包括与所述角支撑臂相连的针支撑件。
9.根据权利要求1所述的穿刺活检组件，该穿刺活检组件还包括侧活检臂，该侧活检臂能够与所述穿刺活检组件相连，以在侧活检过程中支撑活检针。
10.一种能够进行乳房X射线成像和层析X射线照相组合成像的X射线成像系统，该X射线成像系统包括：
X射线源；
X射线检测器，该X射线检测器位于垂直于所述X射线源的平面内；
穿刺活检组件，该穿刺活检组件可拆卸地连接在所述X射线源和所述X射线检测器之间，所述穿刺活检组件包括：
支撑结构，该支撑结构能够与X射线成像系统连接，且位于该X射线成像系统的成像源和图像检测器之间；
固定支撑臂，该固定支撑臂与所述支撑结构相连；
活检装置，该活检装置与角支撑臂相连，该角支撑臂以偏离所述X射线检测器所在的平面的角度与所述固定支撑臂相连，以使该活检装置不会落入该成像源的X射线束内；以及
引导模块，该引导模块连接在所述穿刺活检组件的所述支撑结构和所述固定支撑臂之间，所述引导模块用于确定目标位置的坐标和控制机架安装件的机动移动，并且将所述活检装置连接至确定的坐标，所述机架安装件与所述角支撑臂连接。
11.根据权利要求10所述的X射线成像系统，该机架安装件可移动地与所述角支撑臂相连，以将与所述机架安装件相连的所述活检装置设置在所述目标位置处。
12.根据权利要求11所述的X射线成像系统，其中，利用由X射线成像系统获得的X射线图像数据确定所述目标位置的坐标。
13.根据权利要求12所述的X射线成像系统，其中，所述X射线图像数据包括二维图像数据。
14.根据权利要求13所述的X射线成像系统，其中，所述二维图像数据包括定位像、乳房X射线图像、立体定位像和层析X射线照相组合投影图像中的至少一个。
15.根据权利要求12所述的X射线成像系统，其中，所述X射线图像数据包括三维图像数据。
16.根据权利要求15所述的X射线成像系统，其中，所述三维图像数据包括立体定位图形数据和层析X射线照相组合重建数据。
17.根据权利要求12所述的X射线成像系统，其中，所述X射线成像数据包括二维图像数据和三维图像数据的组合。
18.根据权利要求10所述的穿刺活检组件的所述X射线成像系统，该X射线成像系统还包括用于手动地使所述机架安装件沿所述角支撑臂前进的机构。
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