CN104619263B - 超声引导治疗的人机接口和设备 - Google Patents

超声引导治疗的人机接口和设备 Download PDF

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CN104619263B
CN104619263B CN201380048145.2A CN201380048145A CN104619263B CN 104619263 B CN104619263 B CN 104619263B CN 201380048145 A CN201380048145 A CN 201380048145A CN 104619263 B CN104619263 B CN 104619263B
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image
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CN104619263A (zh
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李·大卫·邓巴
杰西卡·E·帕森斯
罗伯特·H·佩德森
蒂姆·埃切尔斯
格雷戈里·保罗·达林顿
迈克尔·Ph·劳
杰斯-尤里奇·奎斯特卡德
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Mirabilis Medica Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N7/02—Localised ultrasound hyperthermia
    • 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
    • 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
    • A61B2090/378—Surgical systems with images on a monitor during operation using ultrasound

Abstract

一种用于提供组织的实时、图像引导的高强度聚焦超声（HIFU）靶向和治疗的系统和方法。在一个实施例中，该系统包括HIFU声头和带有用于组织的三维可视化的触摸屏显示器的用户界面。显示在所述用户界面上的图像帧描绘了所述组织的实时图像，包括平行于所述声头的特征的图像，和与所述平行图像正交的图像。可以使用触摸屏描画参考线，并且在所述图像帧上显示该参考线。在一个实施例中，既可以通过用户也可以通过系统自动地在所述图像帧上检测和标记组织边界。在另一个实施例中，所述用户界面包括脚踏开关，用于使用户与系统互动。在另一个实施例中，所述系统包括与所述系统分离的超声成像部件，以便用作独立的超声成像设备。

Description

超声引导治疗的人机接口和设备
相关专利的交叉引用
本申请要求2012年7月16日提交的第61/672,213号美国临时专利申请和2013年3月15日提交的第61/798,831号美国临时专利申请的优先权，这些专利申请的全文以引用的方式并入本文中。
背景技术
使用聚焦超声来治疗组织是相对较新的领域。正在开发提供超声治疗的设备，并且正在发现用户和这些设备交互的新方法。
提供图像引导聚焦超声治疗的设备受到越来越多的关注。对于图像引导超声设备，总体原则是提供用户足够的信息，使得它们可以安全有效地靶向和治疗组织。这里描述的起到说明作用的各种设备使用超声成像进行可视化，并且使用高强度聚焦超声进行治疗。
发明内容
提供以下概要说明是为了以一种简化形式介绍选择的发明概念，其在后面的具体实施例中将进一步描述。该概要说明并不意味着识别出要求保护的主题的关键特征，也并不意味着用于确定要求保护的主题的范围。
本发明提供了一种独特方法，在该方法中，用户可以与超声设备交互。本发明还提供了一种方法，在该方法中，设备可以自动响应用户交互，或者作为用户交互的替代。
本发明所述的高强度聚焦超声(High Intensity Focused Ultrasound，HIFU)系统提供了组织的实时的图像引导的HIFU治疗。在至少一个实施例中，一种系统，包括：HIFU声头，用于将HIFU能量传递到组织；HIFU发生器，用于向所述HIFU声头控制和传送HIFU能量；超声成像设备，用于控制所述组织的成像；以及用户界面，该用户界面包括显示器，该显示器可以是触摸屏显示器。所述用户界面用于在所述显示器上显示所述组织的图像，从而实现所述组织的三维可视化，其中，所述图像包括活动平行帧和活动正交帧，所述活动平行帧描绘了平行于所述声头的特征的实时图像平面，所述活动正交帧描绘了与所述活动平行帧正交的实时图像平面。
除了所述活动平行帧和活动正交帧外，所述用户界面可能还用于显示参考帧，其中，所述参考帧包括参考平行帧和参考正交帧。在至少一个实施例中，所述参考平行帧提供所述活动平行帧的静态视图，所述参考正交帧提供所述活动正交帧的静态视图。
所述用户界面可能还用于显示加入到所述参考水平帧和所述参考正交帧的参考行，并且在所述活动平行帧和所述活动正交帧上复制所述参考行。所述用户界面可能包括设备控件，该设备控件可能是通过所述显示器可访问的用于控制所述超声成像设备的一个或多个控制图标。在至少一个实施例中，所述系统用于自动设置和调节一个或多个所述设备控件。
所述系统还可能用于检测和标记组织边界，根据检测到的所述组织边界计算和调节治疗参数，并且在所述显示器上显示标记的所述组织边界。所述用户界面可能用于显示所述组织体积的360度扫描视图。所述超声成像设备可能通过对接接口连接到所述系统。
本发明还提供了一种在组织的实时、图像引导高强度聚焦超声(HIFU)治疗过程中与HIFU系统交互的方法。在至少一个实施例中，一种方法，包括向组织传递HIFU能量以提供治疗，并且在治疗过程中，在用户界面上显示所述组织的超声图像。所述图像包括活动平行帧和活动正交帧，所述活动平行帧描绘了平行于所述声头的特征的实时图像平面，所述活动正交帧描绘了与所述活动平行帧正交的实时图像平面。
除了所述活动平行帧和活动正交帧外，所述方法还包括显示参考帧，其中，所述参考帧包括参考平行帧和参考正交帧。在至少一个实施例中，所述参考平行帧提供所述活动平行帧的静态视图，所述参考正交帧提供所述活动正交帧的静态视图。
所述方法还包括向所述参考水平帧和所述参考正交帧加入参考行，并且在所述活动平行帧和所述活动正交帧上复制所述参考行。
所述方法还包括通过设备控件控制超声成像设备，该设备控件可能是在所述显示器上可访问的一个或多个控制图标。在至少一个实施例中，所述方法包括自动设置和调节一个或多个设备控件。
所述方法可能还包括检测、标记和显示组织边界，以及根据检测到的所述组织边界计算和调节治疗参数。在至少一个实施例中，所述方法包括自动检测、标记和显示组织边界，并且根据检测的所述组织边界自动计算和调节治疗参数。所述方法还包括显示所述组织体积的360度扫描视图。
附图说明
下面参照附图的描述有助于更好地理解本发明的上述方面和许多优点。
图1为根据本发明的至少一个实施例的治疗超声设备的示意图；
图2为根据本发明的至少一个实施例的用户界面布局的示意图，其中，该用户界面包括带有两个描绘正交图像平面的初始画面；
图3为图2所示的实施例中的包括带有图形覆盖的画面的用户界面布局的示意图；
图4为包括带有全容积模式布局的画面的用户界面布局的示意图；
图5为包括带有扫描平面位置手动控制的画面的用户界面布局的示意图；
图6为包括显示了参考和活动图像的预治疗画面的用户界面布局的示意图；
图7为包括带有在瞄准模式中的用户控制的画面的用户界面布局的示意图；
图8为包括显示了勾勒的参考线的画面的用户界面布局的示意图；
图9为包括带有超声成像器控制面板的画面的用户界面布局的示意图；
图10为包括带有脚踏开关控制的预治疗画面的用户界面布局的示意图；
图11为根据本发明的至少一个实施例的治疗超声设备的示意图；
图12为包括带有两个活动图像平面和两个参考平面的画面布局的用户界面布局的示意图；
图13为包括带有两个图像平面的画面布局的用户界面布局的示意图；
图14为包括带有临界控制部分识别的可选的分屏的画面布局的用户界面布局的示意图；
图15为包括覆盖在屏幕上的参考图像的用户界面布局的示意图。
具体实施方式
此部分将对根据本发明的包括用户界面的治疗超声设备的各种实施例进行详细描述。
表1列出了这里描述的设备的至少一个实施例的主要部件。
表1设备主要部件
在至少一个实施例中，图像引导聚焦超声设备10包括用户界面30，该用户界面让用户能够在靶向和治疗组织时对患者组织进行实时可视化。在至少一个实施例中，用户界面30向用户提供可视化的三维组织体积的图像。向用户提供、优选地同时提供：两个实时正交视图42，44(例如，x-z平面和y-z平面，或者在特定实施例中，来自用户的透视的横向平面和矢状平面)，以允许患者组织的基本的三维可视化和应用到该组织的超声跟踪治疗(参见图2)。活动平行帧42提供矢形图像的实时视图。当合适地放置声头时，平行平面穿过声头的长轴，并且平行于穿过该声头的特征(如两个柄)的线(该平面通常平行于用户)。活动正交帧44提供横向平面的实时视图，其与活动平行帧42正交，如图2所示。
这里描述的用户界面30可能包括多个图标，这些图标使得用户能够选择某些功能或者与超声设备10交互。在图2所示的实施例中，例如，每个图像42，44的左上角都显示有图标40，以表明图像平面在患者组织中的方位(位置)。为了将该图像平面与患者关联，可以在超声声头20上以颜色、形状或其他标记或特征的形式提供相应指示。这里描述的实施方是直观的。对于带有两个间隔180度的柄的声头20，一个图像与用户的手(柄)对齐，而另一个图像正交于穿过用户的手的平面。由于沿着穿过柄的平面的左运动可能导致组织“滑过”超声图像(犹如通过范围或视野寻像器观看)，相应的声头运动也是直观的。正交平面关于推开声头20是否导致声头20在组织上的“左滑”或“右滑”是可编程的或可选择的。此外，有一个在用户界面30的屏幕上显示在患者身上移动的声头的图示的规定。该设备10可能使用来自声头20的加速器数据(或其他输入信息，如图像数据)来确定声头20的运动并在用户界面30的屏幕上反映出这种运动。患者相对声头20的方向是用户可设置的(例如，向左转头或向右转头)。这种模式将主要是在训练模式中可用的，但是在治疗期间也是可用的。该数据还将在治疗过程中可用于运动检测，可以单独使用或连同处理的超声图像数据来检测运动，并且可以在治疗过程中通知或警告用户(例如，关于治疗过程中的移动)。
关于识别靶组织，在用户界面30的屏幕上的图形覆盖区50可以用于显示靶区52、安全裕度54，以及前焦和后焦场线56，58(参见图3)。靶区52指示了要治疗的组织。安全裕度54指示了与靶区52之间的距离以便远离关键组织，如浆膜、内脏等。前焦和后焦场线56，58指示了用于整个治疗的总体HIFU场的边界(例如，因为焦点四处移动)。可以采用覆盖打开/关闭图标92关闭或禁用覆盖区50，从而实现无阻挡的观察，然后，当需要的时候再重新启用，例如，用于治疗(参见图7)。
此外，设备10可能向用户提供全体积扫描模式(参见图7的图标100)，其中，扫描平面相对于垂直轴旋转，例如，满180度，以便允许用户能够显影组织的整个体积或某个部分。旋转的相对角度既可以通过用户界面30自动确定，也可以通过用户界面30手动确定(参见图4)。
可以通过用于参考上述正交扫描平面的方向的相同的图标40，向用户指示超声图像的扫描平面位置(角度)，具体地，相对于声头并间接相对于患者的超声图像的扫描平面位置(角度)(参见图4)。此外，用户可以暂停扫描平面位置的自动扫描，并且使用控件60，62和64手动放置扫描平面，例如，如图5所示。
在至少一个实施例中，用户通过随时地、反复地或连续地选择各步骤图标62，63，既可以顺时针也可以逆时针地旋转图像平面。为了重启自动扫描，用户选择选择扫描/暂停图标64。
根据现有的靶向模式，用户提供有两个靶向图像帧。参考平行帧46和参考正交帧48保持作为参考(左边)，两个额外的图像帧(右边)成为活动的，即，活动平行帧42和活动正交帧44(参见图6)。例如，在活动平行帧42和活动正交帧44中，可以实时观察组织，而在参考平行帧46和参考正交帧48中，该组织的图像是在一个时间点捕捉的。
右边的活动图像平面(活动平行帧42和活动正交帧44)用于贯穿治疗疗程的组织治疗的实时追踪，伴随着在左边保持不变的参考图像平面(参考平行帧46和参考正交帧48)。在用户界面30的屏幕上还显示了用于在多个图像滤波器中选择的图标70。这些图像滤波器包括但不限于，使用各种技术移除图像混响伪影的滤波器，和/或边缘、边界或组织增强滤波器。在举例说明的实施例中，大多数控件在靶向和预治疗模式中都是可用的(参见图7)。
用户可以改变治疗参数、初始治疗或退出/关机。以下将描述这些控件的特征和设备10的其他交互或特征。
设备10可能包含多个帮助用户在治疗的过程中追踪患者的组织的特征。首先，在用户界面30的屏幕的左边显示了靶向组织的参考平面(参考平行帧46和参考正交帧48)在治疗的整个过程中保持不变(图6)。其目的是保持声头20的放置位置，以致在用户界面30的屏幕的右边的活动图像(活动平行帧42和活动正交帧44)始终看起来类似参考图像。该参考平面用于确保声头20相对患者的位置在治疗期间保持不变。此外，万一用户在意想不到的方向上移动了该声头20、患者移动了，或者该声头20不在目标位置，用户可以暂停该治疗，重新放置该声头20，使得活动图像类似参考图像对齐，然后重新开始治疗。
其次，用户具有工具80，82，84在参考平面图像上绘制或勾勒参考线110(参见图7和8)。这些参考线110通常用于标记组织边界。可以使用手指、触笔、鼠标、轨迹球、触摸板或其他合适的设备在用户界面30的触摸显示器上绘制参考线110。之后，这些参考线110可以复制在活动平面图像上，其帮助用户将声头20保持在目标位置(图8)。除了绘制工具80，有用于擦除部分或全部参考线的擦除工具82，以及用于擦除所有参考线的擦除功能84。该擦除工具数据可以通过手指、触笔和/或其他类似于画线工具的工具输入。跟覆盖区50一样，线110，112可以是可见的，或者是隐藏的，以便超声图像的无遮挡观察。
还可以使用能够检测显著特征，如参考图像中的边界或边缘的常见的信号和图像处理技术自动生成参考线110。取决于用户的(或自动地)激活，设备10可以根据检测的特征向用户呈现推荐的参考线，用户可以在用户界面30的屏幕上从这些参考线中选择接受所有的参考线、部分的参考线，还是都不接受。此外，设备10的一个实施例可以使用当前已知的信号和图像处理技术(例如，增强整个图像数据的陡峭梯度)来增强组织边界(边缘)。
设备10可能包括用于患者组织的可视化的超声成像系统。该超声成像系统可能是市场上可买到的系统。如本发明所述，商业超声系统的控件可以通过激活图标96(参见图7)包含在HIFU设备10的用户界面30中(参见图9)。
在举例说明的实施例中，呈现给用户的超声成像控件包括时间增益控制(TimeGain Control，TGC)120、启用或禁用谐波成像122，以及调节总增益124。在其他实施例中，用户界面30可能使用呈现给用户的额外的或不同的超声成像控件进行增强。除了用户控件，还有可以由设备10自动调节的控件，如总增益和TGC预设、随着深度的不同的自动增益变化。
在至少一个实施例中，由于成像传感器沿着在传感器流体体积中的HIFU传感器移动，该成像传感器和患者界面间的距离根据HIFU治疗深度而变化。随着治疗深度的减少，传感器流体路径增加，组织路径减少。在这个实施例中，考虑到传感器和靶区间减少的组织路径，设备10减少了超声成像系统的总增益。对于一些成像系统，设备10还可以随着传感器流体路径深度的变化调节输出功率。
此外，设备10可能向用户提供以下选项：边缘增强滤波器(例如，增加图像中的陡峭梯度)、混响和运动滤波(通过多普勒和/或最小滤波)、增强组织硬度间的差别的弹性扫描技术和其他帮助用户区分组织类型(例如，纤维瘤边界的更清晰辨识)的超声成像增强技术。
设备10可能包括多个特征，通过这些特征用户可以设置或调节治疗方案，从而影响治疗参数。例如，在至少一个实施例中，用户首先操作设备10来选择靶区。设备10可能在用户界面提供一个图标，当选择该图标，将(使用，例如，滚动、鼠标或触摸屏选择)带来治疗体积选项的菜单。可选地，显示在用户界面30的屏幕上的靶区可以在每次用户选择在该用户界面30的屏幕上的图标94时改变尺寸和形状(参见图7)。图标94还可以随着每个靶区选择而改变(例如，通过文本或图形方式)，向用户提供反馈。可选地，在其他实施例中，设备10的迭代可以允许用户通过简单地触摸或点击在用户界面30上的靶区边界并拖曳该边界到想要的靶区尺寸和/或形状，改变体积的大小。
每个靶区都可能与一组独特的治疗参数相关，如峰值声功率、占空度和运动模式。在至少一个实施例中，总的靶区有多个单元体积组成，每个单元体积的治疗参数组取决于该单元体积与其他单元体积的相对位置。在一个实施例中，使用预定的治疗体积(例如，球形)来实现设备10，然而，其他实施例，如果需要，可能包括允许用户在正交的平面(或两个以上平面)上勾勒任意形状的界面。在这样的实施例中，设备10配置为根据勾勒的边界，在勾勒的线间内插，并创建体积。创建的靶区显示给用户用于改变或接收。接着，设备10使用一个或多个算法来确定治疗显示的靶区的合适的治疗参数。
第二，由于超声穿过组织时的衰减，治疗方案可能受到治疗的深度的影响。在设备10的至少一个实施例中，用户通过在用户界面30的屏幕上的箭头98选择组织体积(参见图7)。箭头98可以用类似功能代替，如滑动条、输入的数值。此外，设备10的增强功能可能包括触摸或点击靶区并将该击靶体拖拽到用户界面30的触摸屏上的新的靶深度的能力。
第三，治疗方案可能取决于患者其他生理方面的存在，如在声音路径中的膀胱液体。在至少一个实施例中，设备10在用户界面30的屏幕上提供光标来标记膀胱的上下边界。在膀胱液体在声音路径中的情况下，用户可以选择在用户界面30的屏幕上的一个或多个图标90使得光标可见，然后标记该膀胱上下边界。用户可以通过用户界面30的触摸屏拖拽光标来调节光标位置，用户也可以使用触笔、鼠标、方向键、输入值或其他方式来调节光标位置。
在一个实施例中，向用户展示了简单的线光标。在其他实施例中，用户界面30增强为包括弯曲的或任意的曲线以便治疗参数更复杂和更精确的计算。此外，超声设备10的实施例可能使用在图像数据上已知的边界检测算法自动检测膀胱的边界，并且根据检测的边界使用后续的计算来确定治疗参数，因此，消除了用户与该参数交互的需要。
第四，治疗参数可能受患者的腹壁的厚度的影响。类似于膀胱，在至少一个实施例中，用户可能启用在用户界面30的屏幕上的光标，并且使用该光标来识别腹壁深度，以及调节光标的位置来标记更低的壁边界。光标的调节方法利用图标88，并且类似于上述调节膀胱壁光标的方法(参见图7)。此外，类似于膀胱壁检测，设备10的实施例可能使用当前已知的(或后续开发的)方法来自动确定腹壁边界，并随后计算和调节治疗参数。在这两种情况下，自动确定边界可以(例如，通过用户界面30的屏幕)呈现给用户以便确认和/或改变。
第五，在患者接口帽是柔性的并且传感器和患者组织间的传感器流体路径深度取决于系统中的传感器的体积的超声设备10的实施例中，该设备10可能配置为考虑计算超声信号的输出功率的过程中的流体僵持。患者接口相对传感器的位置可以由用户调整(例如，使用用户界面30的屏幕)或由设备10自动确定。在上面举例说明的实施例中，“皮肤线标记”图标86(参见图7)激活图像上的蓝线标记(光标)，其用于标记患者组织(皮肤)的表面。这种人工特征实现和用在设备10的指示一个实施例中，但是，该特征也可以以自动化方式在设备10的其他实施例中实现。在自动化的实施例中，设备10通过找查找从前景暗的或低振幅反射数据到第一亮的或高振幅反射数据的转变，处理图像数据来识别患者组织的边界。其他处理技术可以用于检测这种转变，如处理第一显著反射的原始RF数据。这种第一转变是患者的皮肤，其接着用于计算靶距。
当在预治疗模式中时，在至少一个实施例中，向用户呈现脚踏开关启用的选项(参见图10)。根据脚踏开关的激活，激活的脚踏开关图标120可以用于改变激活治疗图标，并且设备10对HIFU参数编程，并放置传感器以开始治疗。当脚踏开关启用，并且设备10准备进行治疗或有效输出HIFU信号时，设备10处在治疗模式中。
当用户压下脚踏开关时，图标从激活治疗图标变化为停止/暂停治疗图标，并且设备10实施方案来治疗靶向治疗体积。在图标变回到指示预治疗状态的时刻，设备10禁用脚踏开关并通知用户何时完成治疗。如果用户在设备10完成治疗前松开脚踏开关，该图标可能配置为变成不活动的治疗暂停图标，并且设备进入治疗暂停状态。
在治疗暂停状态中，设备10可能配置为向用户显示选项。用户可能选择取消治疗并返回到预治疗状态，或者简单地再次压下脚踏开关，继续使用先前确定的治疗方案治疗靶区。当在治疗暂停状态中，用户还可能选择进入成像状态，并实施靶区的全体积扫描以证实靶区和声音路径的条件，返回到治疗暂停状态，接着，选择取消或返回到向患者组织提供治疗。
当输出治疗性超声信号，设备10可能包括多个指示器来向用户指示治疗正在进行。设备10可能发出声音、在用户界面30的屏幕上显示图标(例如，治疗图标变为停止治疗图标，和/或其他指示)，和/或在输出治疗时点亮声头20。此外，在用户界面30的屏幕上还有治疗计时器，其向用户指示治疗方案的过程。该治疗过程指示器还可以采用进度条、使靶区变暗或其他指示相关方式实现。
虽然上述设备10的实施例采用脚踏开关实现，但是设备10的实施例可能包括一个或多个在声头20上的控制开关、语音命令、接近传感器、上述的组合，或者用户激活HIFU信号输出的其他方式。
当输出治疗时，(相对患者)没有连接的声头20将不会伤害患者，但是它将不会导致有效的治疗和潜在伤害声头20的条件。在至少一个实施例中，设备10监视从患者接口反射的HIFU信号，并将该HIFU信号与预定的阈值进行比较。如果反射的信号大于阈值，设备10假定声头20没有完全连接到患者并通知用户。如果反射的信号小于阈值，将表明设备10连接到患者。在其他实施例中，阈值和比较值可以采用不同配置，以致小于阈值的值表示声头20没有完成连接，大于阈值的值表示设备10连接到患者。此外，设备10可能用于监视从比皮肤线更深的组织(例如，接近焦点)反射的HIFU信号，并且将这些HIFU信号与预期的值进行比较。该数据可以与其他数据结合来增强连接检测算法。
在一些实施例中，设备10允许输入的患者数据(例如，名字等)和存储治疗期间的设备数据(用于分析等)，而设备10的其他实施例可能不向用户提供输入患者数据的选项，并且设备10不存储治疗期间的数据。设备10的进一步实施例可能允许用户输入患者数据，过去、当前或未来治疗的治疗计划信息，或者其他相关数据。此外，设备10还可能存储来自给定疗程或多个疗程的治疗数据(数值、视频和图像)以便用户或其他人的后续使用。
优选地，设备10包括多个增强设备10的安全性的特征。首先，设备10的实施例可能检测如上所述的不完全连接的情况，并将该情况通知用户。监视来自HIFU波形的从患者接口反射回来的能量，如果其是太高(或太低)的值，设备10可能确定该设备10没有适当连接，终端输出治疗，并通知用户检测患者连接。
设备10的进一步实施例可能包括监视在活动图像中的组织边界，并将该组织边界与在参考图像中的组织边界的位置进行比较。如果发现该组织边界没有在预定值(阈值)内，可以显示警告，或者向用户传达该警告，以检查声头相对患者是否对齐。用户可以暂停治疗，在靶组织上重新对齐声头20，或者选择忽略该警告。如果发现该边界没有在第二预定值(阈值)内，设备10可能自动暂停治疗，并且显示错误，或向用户传达该错误，表明治疗被暂停，以检查对齐。然后，用户可以重新放置声头20，清除错误，并重新开始治疗，从而继续治疗靶组织。作为确保声头20对齐在靶上的一种辅助手段(其中，主要手段是用户监视超声图像)，用户可能具有设置两个阈值并且启用或禁用该特征的选项。额外的配置包括加速器，该加速器可以单独使用或结合图像数据使用，以确定声头20的运动，并相应地通知用户。
设备10包括使用单独的超声成像来实现通常超声成像的能力。例如，以下描述了这种特征的两个实现方式。下面的表2列出了在附图中所示的和实施例所述的各超声成像部件。
表2通常超声成像部件
编号 描述
10 治疗超声设备
12 成像超声部件
22 成像超声部件和治疗超声设备的其他部分的连接件
26 手持超声成像探针
24 超声成像探针和治疗超声设备间的连接器
在集成的治疗成像超声的至少一个配置中，HIFU设备10包括一个或多个手持超声成像传感器26的一个或多个连接件24(参见图11)。接着，HIFU设备10用作诊断超声成像系统。
在可对接便携式超声配置中，用户可通过对接接口将超声成像部件12从HIFU设备10断开连接。接着，该超声成像部件12通过连接件26直接连接到成像传感器，并且用作单独的诊断超声成像系统。
可选的用户界面布局包括多个可选的用户与设备10交互的屏幕布局。在一个实施例中，用户界面30的屏幕具有两个活动图像平面和两个参考图像平面(参见图12)。
在这个实施例中，右边的屏幕显示了两个正交图像(活动平行帧42和活动正交帧44)，它们总是活动的(成像)。左边的屏幕(参考平行帧46和参考正交帧48)在第一次进入用户界面时是缺省的，当用户选择(例如，选择捕捉图像)或当用户选择开始治疗(例如，激活脚踏开关)时用右边的图像填充。捕捉图像的特征可能通过多个方式选择，包括但不限于，脚踏开关、在声头20上的开关/传感器、语音命令，或者通过用户界面30的触摸屏。如果用户在激活脚踏开关前已经预先选择了捕捉的图像，该用户可以被提示选择是否替换先前捕捉的图像。一旦设备10处在治疗模式中，参考图像(参考水平帧46和参考正交帧48)是静止的并且不会改变。在其他实施例和/或使用条件中，静止图像，即参考水平帧46和参考正交帧48，可以在治疗模式中替换。
在另一实施例中，用户界面30的屏幕有两个可视的活动的图像平面，即活动水平帧42和活动正交帧44(参见图13)，并且，该图像平面的格式大于四个图像平面的格式(参见图12)。
在这个实施例中，两个正交的图像平面(活动平行帧42和活动正交帧44)通常是活动的，并且不断更新。一旦进入治疗模式(例如，通过激活脚踏开关)，设备10将捕获的参考图像存储在存储器中。如果用户选择观察参考图像(即，在用户暂停治疗并需要重新定位的情况下)，该用户可以选择一图标来使得参考图像显示出来。在至少一个实施例中，用户界面30的屏幕格式可以改变为上述四分屏模式(参见图14)，关键控制功能140的放置位置和可视化在两种格式间保持一致。在可选的实施例中，用户界面30的屏幕格式可能保持不变，并且参考平行帧46和参考正交帧48可以覆盖在用户界面30的屏幕上(参见图15)。
在另一实施例中，用户可以选择两个以上的活动图像平面。例如，可以选择观察等距离分布在体积上(例如，0度、45度、90度和135度)或等距离分布在两个相对象限上(例如，0度、22.5度、67.5度和90度)的四个图像平面。在还有的实施例中，显示器可以包括四个以上的图像平面，例如，带有用户界面30的屏幕的延迟输出和/或更大的显示。
在上述图像显示格式中，用户可以选择还显示360度的扫描视图。在至少一个实施例中，可以通过用单视图360度扫描布局替代双平面视图实现。在另一实施例中，图像显示格式可以具有第三视图，该第三视图包含在两个正交视图中。在一个实施例中，该第三视图可能具有360度扫描视图。在另一实施例中，该第三视图可能显示已渲染的3D体积。在还有的实施例中，该第三视图可以显示冠状面视图。在另一实施例中，四个图像可以显示为两个正交的活动图像、活动的360度扫描和冠状视图。可以认可并理解的是，可以同时显示四个或四个以上活动图像，其中显示的图像为上述视图的任何组合(例如，两个正交视图、360度扫描视图、冠状视图、渲染的3D图像、多普勒图像、应变成像图像和/或其他标准成像模式视图)。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (19)

1.一种用于患者的组织的实时、图像引导的高强度聚焦超声(HIFU)治疗的高强度聚焦超声系统，该系统包括：
HIFU声头，用于将HIFU能量传递到组织；
HIFU发生器，用于控制和传送到所述HIFU声头的HIFU能量；
超声成像设备；以及
用户界面，所述用户界面包括显示器，
其中，所述超声成像设备配置为控制所述组织的成像，从而在所述HIFU系统的工作过程中提供(1)平行于穿过所述HIFU声头的特征的线的第一图像平面的实时视图和(2)正交于所述第一图像平面的第二图像平面的实时视图，其中，所述HIFU声头的特征为所述高强度聚焦超声系统的用户提供将显示的图像平面的方位和所述患者关联的相应指示；以及
其中，所述用户界面用于在所述显示器上显示所述组织的图像，从而实现所述组织的三维可视化，其中，所述显示器同时包括活动平行帧和活动正交帧，所述活动平行帧提供描绘了平行于所述HIFU声头的所述特征的所述第一图像平面的所述实时视图的图像，所述活动正交帧提供描绘了与所述活动平行帧中描绘的所述第一图像平面正交的所述第二图像平面的所述实时视图的图像。
2.根据权利要求1所述的系统，其特征在于，所述用户界面还用于在显示所述活动平行帧和所述活动正交帧的同时，显示参考帧，其中，所述参考帧包括参考平行帧和参考正交帧，所述参考平行帧对应于所述活动平行帧并且提供描绘了所述第一图像平面的静态视图的图像，所述参考正交帧对应于所述活动正交帧并且提供描绘了所述第二图像平面的静态视图的图像。
3.根据权利要求2所述的系统，其特征在于，所述用户界面还用于显示加入到所述参考水平帧和所述参考正交帧中提供的图像中的参考线，并且分别在相应的所述活动平行帧和相应的所述活动正交帧中提供的所述图像上复制所述参考线。
4.根据权利要求1所述的系统，其特征在于，所述用户界面包括设备控件，该设备控件用于控制所述超声成像设备，其中，至少一个所述设备控件是通过所述显示器可访问的控制图标。
5.根据权利要求4所述的系统，其特征在于，所述系统用于自动设置和调节一个或多个所述设备控件。
6.根据权利要求1所述的系统，其特征在于，所述系统还用于：
对组织边界进行检测和标记；
根据检测到的组织边界，计算和调节治疗参数；以及
在所述显示器上的一个或多个图像中显示标记后的组织边界。
7.根据权利要求6所述的系统，其特征在于，所述系统用于自动检测和标记所述组织边界，根据检测的所述组织边界计算和调节所述治疗参数。
8.根据权利要求1所述的系统，其特征在于，所述用户界面用于显示所述组织的360度扫描视图。
9.根据权利要求1所述的系统，其特征在于，所述超声成像设备通过对接接口连接到所述系统。
10.根据权利要求1所述的系统，其特征在于，所述HIFU声头包括可由所述HIFU系统的所述用户操作来移动所述HIFU声头的柄，其中，在所述HIFU声头的移动过程中，所述第一图像平面保持与所述HIFU声头的所述柄的平行。
11.一种操作高 强度聚焦超声(HIFU)系统的方法，该HIFU系统用于将患者组织实时可视化，并且包括HIFU声头、超声成像设备和包括显示器的用户接口，所述方法包括：
操作所述超声成像设备以获取超声图像，该超声图像包括(1)平行于穿过所述HIFU声头的特征的线的第一图像平面的实时视图和(2)正交于所述第一图像平面的第二图像平面的实时视图，其中，所述HIFU声头的特征为所述高强度聚焦超声系统的用户提供将显示的图像平面的方位和患者关联的相应指示；以及在所述用户接口的所述显示器上显示所述超声图像，其中，所述显示器同时包括活动平行帧和活动正交帧，所述活动平行帧提供描绘了平行于所述HIFU声头的所述特征的所述第一图像平面的所述实时视图的图像，所述活动正交帧提供描绘了与所述活动平行帧中描绘的所述第一图像平面正交的所述第二图像平面的实时视图的图像。
12.根据权利要求11所述的方法，其特征在于，所述方法还包括在显示所述活动平行帧和所述活动正交帧的同时显示参考帧，其中，所述参考帧包括参考平行帧和参考正交帧，所述参考平行帧对应于所述活动平行帧并且提供描绘了所述第一图像平面的静态视图的图像，所述参考正交帧对应于所述活动正交帧并且提供描绘了所述第二图像平面的静态视图的图像。
13.根据权利要求12所述的方法，其特征在于，所述方法还包括向所述参考平行帧和所述参考正交帧中提供的图像中加入参考线，并且分别在相应的所述活动平行帧和相应的所述活动正交帧中提供的所述图像上复制所述参考线。
14.根据权利要求11所述的方法，其特征在于，所述方法还包括通过设备控件控制超声成像设备，其中，所述超声成像设备用于在所述用户接口上显示所述组织的超声图像，并且至少一个所述设备控件是在所述用户接口的所述显示器上可访问的控制图标。
15.根据权利要求14所述的方法，其特征在于，所述方法还包括自动设置和调节一个或多个设备控件。
16.根据权利要求11所述的方法，其特征在于，所述方法还包括检测、标记和显示组织边界。
17.根据权利要求16所述的方法，其特征在于，所述方法还包括自动检测、标记和显示组织边界。
18.根据权利要求11所述的方法，其特征在于，所述方法还包括显示所述组织的360度扫描视图。
19.根据权利要求12所述的方法，其特征在于，描绘了所述第一图像平面和所述第二图像平面的静态视图的参考图像存储在存储器中，所述方法还包括：
选择在所述用户接口上的图标，使得存储在所述存储器中的参考图像被显示，其中，所述活动平行帧变成提供描绘了平行于所述HIFU声头的所述特征的所述第一图像平面的静态视图的图像的参考平行帧，所述活动正交帧变成提供描绘了正交于在所述参考平行帧中描绘的所述第一图像平面的所述第二图像平面的静态视图的图像的参考正交帧。
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US20140018708A1 (en) 2014-01-16
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