CN109152550A - 用于组织切割边缘测量装置的系统和方法 - Google Patents

用于组织切割边缘测量装置的系统和方法 Download PDF

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CN109152550A
CN109152550A CN201780029014.8A CN201780029014A CN109152550A CN 109152550 A CN109152550 A CN 109152550A CN 201780029014 A CN201780029014 A CN 201780029014A CN 109152550 A CN109152550 A CN 109152550A
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sensor
tissue block
controller
surgical apparatus
signal
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R·比诺
J·贾伽蒂森
F·A·乔乐兹
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Brigham and Womens Hospital Inc
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Brigham and Womens Hospital Inc
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Abstract

本发明的实施方式提供了用于切除组织块的系统和方法。用于切除组织块的系统包括手术设备和第一传感器，用于测量对应组织块的位置和方向信号。第一传感器的尺寸契合组织块内或组织块旁。系统还包括接合手术设备的第二传感器，其设置成测量手术设备的位置和方向。第二传感器设置成接收来自第一传感器的信号。控制器与第一传感器和/或第二传感器连通，并且控制器执行存有的程序以计算第一和第二传感器之间的距离。相应地，向临床医师提供视觉、听觉、触觉或其他反馈以引导手术设备至手术切缘。

Description

用于组织切割边缘测量装置的系统和方法
相关申请的交叉引用
本申请是2014年9月5日提交的PCT/US2014/054310的部分继续申请，PCT/US2014/054310要求2013年9月6日提交的题为“用于组织切割边缘测量装置的系统和方法”的美国临时专利申请系列号61/874,675的权益，通过引用将该申请全文纳入本文用于所有目的。
关于联邦资助研究的声明
不适用。
背景技术
肿瘤的微创手术切除涉及精确切除肿瘤，同时保护周围健康和关键组织。一些示例包括但不限于，乳房保留手术和视频辅助的胸腔手术(VATS)。肿瘤的手术切除需要去除肿瘤周围组织的边缘以确保肿瘤细胞的完全去除并改善长期存活。默认的边缘取决于肿瘤的类型以及肿瘤对周围组织的微侵入(micro-invasion)。由于高粘弹性或生理运动(如肺塌陷)而导致组织的显著变形可以导致难以定位肿瘤以及精确去除肿瘤。因此，这可能导致肿瘤复发以及长期益处差。下述两种手术应用作为示例。然而，公开的系统和方法可以通过微创途径或开放手术应用于其它病灶的切除或活组织检查。
当前去除肺组织片段的临床实践涉及通过切割胸骨或通过扩张肋骨进行开胸。很多时候肋骨将会断裂，并且通常在这些手术期间手术去除片段。单是骨科创伤就存在相当大的疼痛，并且其可以使患者的恢复过程复杂化。这种程度的胸痛也使得由全身麻醉中复苏患者的任务复杂化，因为身体适应了强制通气并且疼痛可以中断自然的胸部节律。患者将显著受益于这样的手术，所述手术通过胸腔内小切口或端口进行，不导致这种骨科创伤。
相对较少的胸腔手术目前使用微创或VATS技术进行，尽管已经知道相较于开胸手术，通过减少创伤并且加速恢复时间，它们将为患者提供益处。这是因为(至少部分的原因是)这样的事实：只有很少的可用设备专门设计成能够以这样的方式进行胸腔手术。
然而，针对肺癌的手术正在转向使用VATS进行的微创手术以及较小的非解剖性肺切除术(即楔形切除术)，特别是对于小病灶。然而在进行VATS的传统方法中，肺的坍塌导致难以精确定位肿瘤以及确定切割边缘。此外，因为手术的微创方式，肺组织的触诊是不可能的。不精确的手术切除可能导致后续的肿瘤复发，增加关键结构的压力以及可能使组织破裂。
乳房保留手术(BCS)涉及去除肿瘤并保护肿瘤周围的健康乳房实质。研究已经显示，与化疗组合的BCS具有与乳房切除术相似的长期益处，以及额外的美容优势。然而，由于乳房的高度可变性性质，鉴定并切除整个肿瘤是一项富有挑战性的任务。由于乳房的软组织性质，实现对健康实质具有最小损伤的阴性手术边缘非常重要的。
因此，需要克服了上述限制的组织切割边缘测量装置。
发明内容
本发明涉及用于切除组织块同时补偿由于其弹性性质和生理诱导的运动而引起的组织变形的系统和方法。在一个非限制性实施例中，本发明通过提供这样的装置和方法能够进行微创手术，所述装置和方法进行区分创伤关键组织并且精确确定切割边缘的组织切除。此外，可以向外科医师提供听觉、视觉和触觉提示以鉴定并且更精确地测量肿瘤边缘来确保肿瘤的完整切除。
本发明的一些实施方式提供了用于切除组织块的系统和方法。该系统包括手术设备和用于测量第一信号的第一传感器。第一传感器的尺寸契合组织块内或组织块旁(例如，靠近)。该系统还包括用于测量第二信号的第二传感器，并且第二传感器与手术设备联接。控制器与第一传感器和第二传感器连通，并且控制器基于第一信号和第二信号执行存有的程序以计算第一和第二传感器之间的距离。
在一些实施方式中，该系统还包括套筒，其尺寸啮合以下至少其一：第二传感器和手术装置的壳体中。例如，第二传感器可以通过粘合剂与手术设备的壳体联接。例如，该手术装置可以是，例如吻合器、波维笔(Bovi pencil)和切割装置，其设置成沿着围绕组织块的切割边缘切割，所述组织块可以是例如肿瘤、结节或病灶。切割边缘可以包括在第一传感器和第二传感器之间计算的距离内。
在其他实施方式中，第一传感器接收的第一信号可以指示组织块相对手术设备的实时位置和方向。相似地，第二传感器接收的第二信号可以指示手术设备相对组织块的位置和方向。在一实施方式中，第二传感器以与第一传感器相同的参照指示手术设备的位置和方向。第一传感器可以是基准标记物，其嵌入由超弹性材料制造的锚固件，并且第二传感器可以是设备传感器。在一实施方式中，第一传感器可以设置成测量组织块的位置和方向，而第二传感器可以设置成测量手术设备的位置和方向。
在一实施方式中，系统还可以包括用于测量第三信号的第三传感器。第三传感器的尺寸可以契合在与第一传感器相对的位置置于组织块旁，从而使得由第三传感器接收的第三信号指示组织块相对第一传感器的位置和方向。
在其他实施方式中，第一传感器可以嵌入钩结构。钩结构可以处于T字架或J字架形状，并且尺寸契合内置于递送针和/或套管。递送针和/或套管可以设置成引导第一传感器，而钩结构可以设置成锚固第一传感器锚于组织块内。在一实施方式中，嵌入钩结构的第一传感器在实时成像导引下可以插入组织块。
在另一实施方式中，第一传感器嵌入包括多个尖头的钩结构，而第一传感器的尺寸可以契合内置于递送针和/或套管。递送针和/或套管可以设置成引导第一传感器，而多个尖头可以设置成锚固第一传感器于组织块内。钩结构可以还包括由钩结构管部分延伸的多个延伸部分，因此多个延伸部分的尺寸可以收纳第一传感器。
系统还可以包括与控制器连通的显示器。显示器可以与手术设备联接，并且设置成显示通过存有的程序计算的距离，所述存有的程序由控制器执行。显示器可以是但不限于OLED显示器或LCD显示器。在其他实施方式中，系统可以包括用于发送声音信号的声源。声源可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变声音信号。在一实施方式中，存储的程序是导航系统。
系统可以还包括压电致动器，其联接手术设备的手柄。压电致动器可以设置成发射触觉信号。压电致动器可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变触觉信号。
系统还可以包括监视器，用于在一些实施方式中发射视觉信号。监视器可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变视觉信号。另外或替代地，系统可以包括用于显示视频覆盖图(video overlay)的监视器。监视器可以与控制器连通，所述控制器设置成执行存有的程序，以将腹腔镜图像融合到虚拟内窥镜图像来生成视频覆盖图。视频覆盖图可以设置成鉴定组织块和第一传感器的位置。
在另一实施方式中，本发明提供了用于切除患者体内组织块的方法。该方法包括将第一传感器插入组织块内或组织块旁(例如，靠近)并且捕获嵌入于组织块内或组织块旁(例如，靠近)的第一传感器的至少一幅图像。使用该至少一幅图像计算围绕组织块的切割边缘。将手术设备插入所述患者内，将手术设备与第二传感器联接。相对于切割边缘追踪第二传感器，并将手术设备用于切割切割边缘。
在一些实施方式中，该方法还包括设置这样尺寸的套筒，以使其啮合以下至少其一：第二传感器和手术装置的壳体。例如，第二传感器可以通过粘合剂与手术设备的壳体联接。例如，该手术装置可以是，例如吻合器、波维笔(Bovi pencil)或切割装置，其设置成沿着围绕组织块的切割边缘切割，所述组织块可以是例如肿瘤、结节或病灶。切割边缘可以包括在第一传感器和第二传感器之间计算的距离内。
在其他实施方式中，第一传感器接收的第一信号可以指示组织块相对手术设备的实时位置和方向。相似地，第二传感器接收的第二信号可以指示手术设备相对组织块的位置和方向。在一实施方式中，第二传感器以与第一传感器相同的参照指示手术设备的位置和方向。第一传感器可以是由超弹性材料构建的基准标记物，而第二传感器可以是设备传感器。在一实施方式中，第一传感器可以设置成测量组织块的位置和方向，而第二传感器可以设置成测量手术设备的位置和方向。
在一实施方式中，方法还可以包括用于测量第三信号的第三传感器。第三传感器的尺寸可以契合在与第一传感器相对的位置置于组织块旁，从而使得由第三传感器接收的第三信号指示组织块相对第一传感器的位置和方向。
在其他实施方式中，第一传感器可以嵌入钩结构。钩结构可以处于T字架或J字架形状，并且尺寸契合内置于递送针和/或套管。递送针和套管可以设置成引导第一传感器，而钩结构可以设置成锚固第一传感器于组织块内。在一实施方式中，嵌入钩结构的第一传感器在实时成像导引下可以插入组织块。
在另一实施方式中，第一传感器嵌入包括多个尖头的钩结构，而第一传感器的尺寸可以契合内置于递送针和/或套管。递送针和/或套管可以设置成引导第一传感器，而多个尖头可以设置成锚固第一传感器于组织块内。钩结构可以还包括由钩结构管部分延伸的多个延伸部分，因此多个延伸部分的尺寸可以收纳第一传感器。
方法还可以包括提供与控制器连通的显示器。显示器可以与手术设备联接，并且设置成显示通过存有的程序计算的距离，所述存有的程序由控制器执行。显示器可以是但不限于OLED显示器或LCD显示器。在其他实施方式中，方法可以包括由声源发送声音信号。声源可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变声音信号。在一实施方式中，存储的程序是导航方法。
方法可以还包括由联接手术设备手柄的压电致动器发射触觉信号。压电致动器可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变触觉信号。
在一些实施方式中，方法可以还包括在监视器上发射视觉信号。监视器可以与控制器连通，所述控制器设置成执行存有的程序，以根据第一传感器和第二传感器之间的距离改变视觉信号。另外或替代地，方法可以包括在监视器上显示视频覆盖图。监视器可以与控制器连通，所述控制器设置成执行存有的程序，以将腹腔镜图像融合到虚拟内窥镜图像来生成视频覆盖图。视频覆盖图可以设置成鉴定组织块和第一传感器的位置。
通过以下详述、附图和所附权利要求书可以更好地理解本发明的这些特征、方面和优点，以及其他的特征、方面和优点。
附图说明
图1A是通过根据本发明一个实施方式的递送针部署的示例性基准传感器的透视图。
图1B是通过根据本发明一个实施方式通过递送针部署于组织块旁的图1A示例性基准传感器的透视图。
图1C是通过根据本发明一个实施方式通过递送针部署于组织块旁的图1A示例性基准传感器和附加基准传感器的透视图。
图2是通过根据本发明另一个实施方式的嵌入钩结构的示例性基准传感器的透视图。
图3A是嵌入图1B组织块的基准传感器的透视图，带有围绕该组织块的切割边缘。
图3B是嵌入图1B组织块旁的基准传感器的透视图，带有围绕该组织块的切割边缘。
图4是用于组织块切除的传统吻合器装置的局部透视图。
图5是具有套筒的图4吻合器装置的局部透视图，其包括根据本发明一个实施方式的吻合器装置外壳上的设备传感器。
图6是插入患者体内并且显示了基准传感器和设备传感器之间的距离的图5吻合器装置的透视图。
图7A是覆盖于腹腔镜视图的组织块虚拟内窥镜视图的示例性截屏。
图7B是组织块腹腔镜视图的示例性截屏。
发明详述
在详细说明本发明的任何一个实施方式之前，应理解的是本发明在其应用中不局限于以下说明中所陈述或下述附图中所示的构造的详细内容和各组分的排列。本发明能够具有其他实施方式并且能够以各种方式实践予以实施和执行。另外，应理解的是本文中使用的词语和术语是为了描述的目的而不应被认为是限制性的。本文使用“包含”、“包括”或“具有”及其变形意味着涵盖其后列出的项目及其等价物以及额外的项目。除非另有说明或限制，术语“安装”、“连接”、“支持”和“联接”及其变形以宽泛含义应用并且涵盖直接和间接的安装、连接、支持和联接。此外，“连接”和“联接”并不限于物理或机械的连接或联接。
下述讨论是为了使本领域技术人员能够制造和使用本发明的实施方式。对于所述实施方式的各种改良对本领域技术人员显而易见，且本文的基本原则可应用于其他实施方式和应用而不背离本发明的实施方式。因此，本发明的实施方式并不旨在限于所示实施方式中，而应按照与本文所公开原理和特征一致的最广泛的范围。下述详细的描述将参考附图进行阅读，其中不同附图中的相同元件具有相同的附图标记。附图并不一定按比例绘制，其描绘了选定的实施方式，并且并不旨在限制本发明实施方式的范围。本领域技术人员将意识到本文所提供的实施例具有许多可用的替代方式并且落入本发明实施方式的范围内。
图1A-1C阐释了通过递送针12插入示例性基准传感器10。该基准传感器10可以是例如包括发射器的标记物，所述发射器测量组织块18的实时位置和方向。基准传感器10可以连接电线14，如图1A-1C所示，或者基准传感器10可以是无线的。基准传感器10可以嵌入钩结构16，如图1A所示。基准传感器10的钩结构16可由超弹性材料制成，例如镍钛诺或不锈钢，或任何其它合适的材料。这将允许基准传感器10通过递送针12插入并且通过递送针12的开口22(即内腔)部署于组织块18的周围或中心。例如，组织块18可以是例如肿瘤、结节或病灶。
如图2所示，显示了基准传感器10和钩结构16更加详细的视图。钩结构16可以包括管部分15，其具有由管部分15一端延伸的多个延伸部分17和由管部分15相对的一端延伸的多个尖头20。例如，管部分15可以是具有约0.6毫米至约0.8毫米之间外直径D1的镍钛诺管，以及可以具有约8毫米至约12毫米总长度L的钩结构16。管部分15可经激光微机械加工成圆柱形，其具有由此延伸的多个延伸部分17，以将基准传感器10固定于位置。在一些实施方式中，基准传感器10可以是电磁观察器，其使用医疗级别环氧胶粘剂(如AA-接合FDA22)连接于钩结构16的近端。
多个尖头20(如图2所示)可以设置成将钩结构16(包括基准传感器10)锚固于组织块(如图1B的组织块)内。多个尖头20可以由超弹性形状记忆合金(如镍钛诺)构建。例如，多个尖头20可以被弯曲，并且由钩结构16中心轴Y向外延伸。多个尖头20还可以进热处理以保证尖头20保持弯曲的形状，并且镍钛诺的相结构处于例如马氏体相。在图2所示的实施方式中，钩结构16包括三个尖头20，然而，为了将钩结构16锚固于组织块，可以包括任何合适数量的尖头。
沿着钩结构16的基准传感器10可以通过递送针12的远端插入，例如，所述递送针12可以是18号针。钩结构16的多个尖头20可以首先插入递送针12的内腔22。有利的是由于镍钛诺的超弹性，钩结构16可以容易地插入递送针12的内腔22。可以使用插入通过递送针12内腔22的金属通管丝(未示出)部署钩结构16。一旦被部署后，多个尖头20将恢复其原始弯曲形状并且打开，以将钩结构16牢固地锚固于组织块18内。然后在部署钩结构16后可以将递送针12去除。
在一些实施方式中，基准传感器10与钩结构16可以在实时成像引导(即CT、DynaCT、MRT、超声等)下通过递送针12在插入并且嵌入于组织块18内，如图3A所示，或组织块18旁(例如，靠近)，如图3B所示。基准传感器10可以在手术过程前或期间嵌入组织块18内或组织块18旁。通过使用实时成像引导，全程知道基准传感器10与组织块18三维空间关系(即位置和方向)。例如，钩结构16可以处于T字架或J字架的形式以将基准传感器10锚固于组织块18内或组织块18旁，从而禁止移动。有利地是因为电线14，该力位于T字架16的中心，从而促进将基准传感器10锚固于组织块18旁。嵌入组织块18内或组织块18旁的基准传感器10将实时测量组织块18的位置和方法，无论由于软组织变形或生理运动(例如肺塌陷或呼吸)所引入的任何变形。因此容易鉴定常常难以确定的组织块18的位置。
在另一实施方式中，如图1C所示，第二基准传感器11为T字架形状，例如，其可以被放置于组织块18旁的不同位置。第二基准传感器11可以具有与第一基准传感器10分离的电缆14，如图1C所示，或者第一基准传感器10和第二基准传感器11可以共享相同的电缆14。第二基准传感器11或任何其它这类装置可以用于改善组织块18的定位，即使可能存在变形时。例如，第二基准传感器11可以置于组织块18与第一基准传感器10相对的一侧，并且可以通过电磁场中扭曲被第一基准传感器10识别。因此，通过知道组织块18位于这两个传感器之间，尽管软组织发生改变，可以定位组织块18。
现在根据图3A和3B，一旦知道组织块18的位置和方向，具有围绕组织块18的预定距离D2的切割边缘24通过生成围绕组织块18的三维封套确定。切割边缘24可以手动设定至所需预定距离D2，例如2厘米。预定距离D2限定阈值，所以当手术装置26(后续在下述内容中描述)位于小于阈值位置时，可以向外科医师或者手术装置26提供听觉、视觉和/或触觉提示以保证组织块18的精确和完整切除。
现在根据图4，示出传统的手术装置26，如手术吻合器、波维笔、凯尼氏(kitner)腹腔镜和/或任何合适的切割、切除或去除装置。手术装置26可以包括手柄30，其与紧固组合件32联接于手术装置26的相对端。紧固组合件32可以是一次性组件，其可移除地连接手柄30。也就是，紧固组合件32可管壳，以是一次性组件，其连接手柄30并在使用后移除。紧固组合件32包括含有多个紧固件36的壳体34，所述紧固件36在切除组织块18期间固定于组织。紧固组合件32可以还包括刀片槽38，其容纳用于沿着组织块18的切割边缘24切割的刀片(未示出)。
在优选的实施方式中，手术装置26包括套筒40，其尺寸能在壳体34上滑动，例如，如图5所示。例如，套筒40可以是例如设置成在手术装置26壳体34上运动的任何市售可得的套筒。设备传感器28可以通过例如缝合与套筒40连接。或者，设备传感器28可以经由任何合适的粘合剂直接连接于手术装置26壳体34或整合于壳体34内。无论设备传感器28连接于何处，套筒40或壳体34，设备传感器28可以与嵌入组织块18内或组织块18旁的基准传感器10相同的成像参照系测量手术装置26的位置和方向。换言之，可以精确测量手术装置26相对于组织块18内或组织块18旁的基准传感器10的位置，如下述具体描述。因为基准传感器10和设备传感器28两者在相同的参照系中测量，所以可以将由于配准和校准步骤需要改变参照轴而引入的误差最小化。
套筒40还可以包括向使用者显示图6所示手术装置26与切割边缘24的距离D3的显示器42，如下述。显示器24可以连接手术装置26的手柄30，并且可以是任何市售可得的有机发光二极管(OLED)显示或液晶(LCD)显示器。在OLED显示器的情况中，可以向使用者显示位于手术装置26尖端的组织块18的重定格式化CT成像。
现在根据图6，在手术期间，基准传感器10使用钩结构16的多个尖头20定位于组织块18旁或嵌入组织块18，如之前所述。例如，进行CT/MRI/荧光镜检验以获取嵌入组织块18内的基准传感器10的图像。然后将组织块18从手术前诊断CT/MRT检验片段化，并且生成组织块18的三维模型(未示出)。布置基准传感器10期间获得的手术中图像可以记录于患者的诊断检查，并且可以估计基准传感器10的位置。如之前所讨论的，具有围绕组织块18预定距离D2的切割边缘24在监视器(未示出)上向使用者显示为围绕组织块18的近似范围或三维封套。切割边缘24的预定距离D2可以基于外科医师的偏好以及组织块18的类型确定。
如图6所示，然后将手术装置26插入身体44(即患者)以沿着切割边缘24切割组织块18。嵌入组织块18内或旁边的基准传感器10与控制器48处于电连通或无线连通。控制器48可以是可编程序逻辑控制器(PLC)，并且设置成解释由基准传感器10生成的信号。例如，基准传感器10可以是电磁传感器，其生成与基准传感器10位置和方向(例如，GPS坐标)成比例的信号。由基准传感器10生成的信号可以是例如电信号，而控制器48可以经由存有的程序50干扰该信号。存有的程序50可以包括例如导航系统，其与基准传感器10和设备传感器28连通。
相似地，例如，设备传感器28可以是电磁传感器，其生成与设备传感器28位置和方向(例如，GPS坐标)成比例的信号。由设备传感器28生成的信号可以是例如电信号，而控制器48可以经由存有的程序50解释该信号。基准传感器10和设备传感器28与控制器48连通，并且使用导航系统传播手术装置26和组织块18的位置和方向。在一些实施方式中，存有的程序50可以设置成允许校准和/或配准算法以追踪手术装置26的远尖端以及手术装置26的法向量。此后，控制器48存有的程序50计算基准传感器10和设备传感器28之间的距离D3(图6所示)，因此当手术装置26低于D3阈值时，为用户生成听觉、视觉或触觉提示。
由于手术装置26被导航至组织块18的切割边缘24，手术装置26可以切除组织块18，同时将由于对基准传感器10和设备传感器28两者的主动追踪而导致的对周围组织的损伤最小化。对周围健康组织最小的损伤还保证正常生理功能，例如肺功能。利用来自手术装置26上的基准传感器10和设备传感器28的反馈，使用者可以知道组织块18和手术装置26的距离D3并且全程显示于显示器42。因此，全程可以保持所需的切割边缘24，从而保证组织块18的完整切除。在另一实施方式中，组织块18和手术装置26的位置和方向数据可以锁定或解锁手术装置26以避免组织块18的错误切除。
在一些实施方式中，控制器48存有的程序50可以设置成包括一个多个形变算法，其估计手术期间切割边缘24因为组织块18和/或周围组织变形可能出现的变化或将其建模。形变算法试图计算切割边缘24的任何这类改变以在手术期间向用户提供更准确的切割边缘，这将助于完整切除组织块18，同时限制对于健康周围组织的损伤或移除。
在一非限制性实施例中，存有的程序50包括形变算法，其假设组织块18(例如，乳腺肿瘤)是刚性的并且周围组织(例如，薄壁组织)变形。该算法假设组织块18上的各点与基准传感器10一起移动，所述基准传感器10如上所述锚固于组织块18。在另一非限制性实施例中，存有的程序50包括形变算法，其假设组织块18是通过粘弹性或流体介质移动的刚性物体。在另一非限制性实施例中，可以测量组织块18和周围组织的患者特异性性质，例如，经由CT/MRI/荧光镜检，以预测对于具体患者手术期间发生的组织块18变形。应当理解的是，存有的程序50的形变算法可以与存有的程序50的导航系统在实时的基础上操作。
更具体地，组织块18(例如肿瘤)可以由获得的容积图像(例如由CT/MRT/荧光镜检)片段化以创建表面模型。基于使用者输入导航系统的默认切割边缘，分段化肿瘤标签图可以扩张至所需的切割边缘以生成对应切割边缘的组织块表面模型。由于肿瘤和周围组织的变形，切割边缘可以改变，例如，由于患者的运动。因此可以由肿瘤或切割边缘的表面模型生成线性弹性容积有限元模型(“FEM”)网格。使用FEM模型，在给定的基准传感器10的实时位置测量下，可以估算组织块18其它结节的位移。刚度值对于EFM模型可能不完全准确，并且FEM模型在一实施例中可能限于组织块18和周围组织。因此基于FEM网格中估计的刚度值的不确定性可以向用户实时提供组织块18和周围组织变形的不确定性测量。
如上所述，可以向外科医师和/或手术装置26提供听觉、视觉和触觉提示以鉴定切割边缘24，从而保证组织块18的精确和完整切除。例如，声源52可以设置成发生声音信号。声源52可以与控制器48连通，所述控制器设置成执行存有的程序50，以根据设备感器28和基准传感器10之间的距离D3改变声音信号。设备传感器28使用由基准传感器10生成的信号以使控制器48执行存有的程序50来计算基准传感器10和设备传感器28之间的距离D3(示于图6)，从而当手术装置26低于阈值D3时生成声音信号。声音信号可以是例如音调，哔哔声或警报声。还可以随着距离D3的减少增加声音信号的频率或占空比，因此当将手术装置26导航得太靠近切割边缘24时，声音信号的频率或占空比增加。
除了听觉提示，也可以在与控制器48连通的一个或多个显示器54上向使用者提供视觉提示。一个或多个显示器52可以包括例如一个内窥镜显示器或分离的监视器。例如，内窥镜显示器或分离的监视器可以设置成发生视觉信号。内窥镜显示器或分离的监视器可以与控制器48连通，所述控制器设置成执行存有的程序50，以根据设备感器28和基准传感器10之间的距离D3改变视觉信号。设备传感器28使用由基准传感器10生成的信号以使控制器48执行存有的程序50来计算基准传感器10和设备传感器28(例如，靠近手术装置26的尖端)之间和/或设备传感器(例如，靠近手术装置26的尖端)和对钩结构16的法向量之间的距离D3(示于图6)，从而当手术装置26低于阈值D3时生成视觉信号。视觉线号可以是例如示于一个或多个显示器54(如内窥镜显示器或分离的监视器)的发光或闪烁光。例如，还可以随着距离D3的减少增加视觉信号的频率或亮度，因此当将手术装置26导航得太靠近切割边缘24时，视觉信号的频率或亮度增加。
在一非限制性实施例中，视觉提示可以颜色变化范围在例如显示器54之一上显示。例如，颜色变化范围可以代表组织切割边缘24，因此颜色基于设备传感器28和基准传感器10之间的距离D3而变化。因此，例如，当设备传感器28接近基准传感器10时，范围可以在显示器54中以第一颜色显示。同样，例如，当设备传感器28远离基准传感器10移动时，范围可以在显示器54上以第二颜色显示，从而允许外科医师视觉上确定设备传感器28和基准传感器10之间的距离D3。
尽管可以向临床医生提供定量、视觉和听觉提示以鉴定切割边缘24离手术设备26的距离，视觉提示可以还包括向使用者提供显示于与控制器48连通的一个或多个显示器54的视频覆盖图。例如，可以将腹腔镜图像和虚拟内窥镜图像融合以实现视频覆盖图，从而确认基准传感器10和组织块18的位置，如图7A的显示器54上所示。基于腹腔镜56的位置，如图7B的显示器54上所示，可以生成三维解剖的虚拟内窥镜视频。可以输入视图的焦距和场以控制使用(例如)三维视图可视化工具包相机生成的虚拟内窥镜视图。
也可以在手术装置26上向使用者提供触觉提示。例如，压电致动器46可以连接手术装置26的手柄30，其被设置成发射触觉信号。压电致动器46可以与控制器电连通，所述控制器设置成执行存有的程序50，以根据设备感器28和基准传感器10之间的距离D3改变触觉信号。设备传感器28使用由基准传感器10生成的信号以使控制器执行存有的程序50来计算基准传感器10和设备传感器28之间的距离D3(示于图6)，从而当手术装置26低于阈值D3时生成触觉信号。触觉信号可以是例如施加于手术装置26手柄30的振动。例如，还可以随着距离D3的减少增加触觉信号的振幅和/或频率，因此当将手术装置26导航得太靠近切割边缘24时，触觉信号的振幅和/或频率增加。
尽管用于切除组织块的上述系统和方法被描述为用于涉及肺部的手术，但是其也适用于切除身体的任何其它器官或结构中的肿瘤或非肿瘤病灶，例如，乳房保留手术的切除、肉瘤切除、部分肾切除或肺楔形切除手术。此外，用于切除组织块的上述系统和方法并不限于VATS或微创手术。

Claims (45)

1.一种用于切除组织块的系统，所述系统包含：
手术设备；
用于测量第一信号的第一传感器，所述第一传感器的尺寸契合以下至少其一：所述组织块内和所述组织块旁；
用于测量第二信号的第二传感器，所述第二传感器与所述手术设备联接；
与所述第一传感器和所述第二传感器连通的控制器；并且
其中所述控制器基于所述第一信号和所述第二信号计算所述第一传感器和所述第二传感器之间的距离。
2.如权利要求1所述的系统，还包含：
套筒，其尺寸啮合以下至少其一：所述第二传感器和所述手术装置的壳体。
3.如权利要求1所述的系统，其中由所述第一传感器接收的所述第一信号实时指示所述组织块相对于所述手术设备的位置和方向，而由所述第二传感器接收的所述第二信号指示所述手术设备相对于所述组织块的位置和方向。
4.如权利要求1所述的系统，其中所述第一传感器嵌入钩结构，所述钩结构为T字架形式并且尺寸契合内置于以下至少其一：递送针和套管；
其中所述递送针和所述套管中的至少一个设置成引导所述第一传感器，而所述钩结构设置成将所述第一传感器锚固于组织块内。
5.如权利要求4所述的系统，其中嵌入所述钩结构的所述第一传感器在实时成像导引下插入所述组织块。
6.如权利要求1所述的系统，其中所述第一传感器嵌入钩结构，所述钩结构包括多个尖头，并且其尺寸契合内置于以下至少其一：递送针和套管；
其中所述递送针和所述套管中的至少一个设置成引导所述第一传感器，而所述多个尖头设置成将所述第一传感器锚固于组织块内。
7.如权利要求6所述的系统，其中所述钩结构还包含由所述钩结构的管部分延伸的多个延伸部分，所述多个延伸部分的尺寸能收纳所述第一传感器。
8.如权利要求1所述的系统，其中所述第一传感器是基准标记物，所述基准标记物包括超弹性材料。
9.如权利要求1所述的系统，还包括：
围绕所述组织块的切割边缘，所述切割边缘包括在所述第一传感器和所述第二传感器之间计算的距离内。
10.如权利要求1所述的系统，其中所述组织块为肿瘤、结节和病灶中的至少一种。
11.如权利要求1所述的系统，其中所述手术设备为吻合器、波维笔和切割装置中的至少一种。
12.如权利要求1所述的系统，其中所述第二传感器以与所述第一传感器相同的参照指示所述手术设备的位置和方向。
13.如权利要求1所述的系统，还包含：
与所述控制器连通的显示器，所述显示器联接所述手术设备，并且设置成显示通过存有的程序计算的距离，所述存有的程序由所述控制器执行。
14.如权利要求13所述的系统，其中所述显示器是OLED和LCD显示器中的至少一种。
15.如权利要求1所述的系统，还包括：
用于发射声音信号的声源，所述声源与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述声音信号。
16.如权利要求1所述的系统，还包括：
用于发射触觉信号的压电致动器，所述压电致动器与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述触觉信号。
17.如权利要求16所述的系统，其中所述压电致动器联接手术设备的手柄。
18.如权利要求1所述的系统，还包含：
用于发射视觉信号的监视器，所述监视器与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述视觉信号。
19.如权利要求1所述的系统，还包含：
用于显示视频覆盖图的监视器，所述监视器与所述控制器连通，所述控制器设置成执行存有的程序，以将腹腔镜图像融合到虚拟内窥镜图像来生成所述视频覆盖图，
其中所述视频覆盖图设置成鉴定所述组织块和所述第一传感器的位置。
20.如权利要求1所述的系统，其中所述第一传感器是基准传感器，而所述第二传感器是设备传感器；
其中所述第一传感器设置成测量所述组织块的位置和方向，而所述第二传感器设置成测量所述手术设备的位置和方向。
21.如权利要求1所述的系统，其中所述控制器执行包括导航系统的存有的程序。
22.如权利要求1所述的系统，其中所述控制器执行包括形变算法的存有的程序。
23.如权利要求1所述的系统，其中所述第二传感器通过粘合剂联接手术设备的壳体。
24.如权利要求1所述的系统，其还包含用于测量第三信号的第三传感器，并且其尺寸契合在与所述第一传感器相对的位置置于所述组织块旁；
其中所述第三传感器接收的所述第三信号指示所述组织块相对于所述第一传感器的位置和方向。
25.一种切除患者内组织块的方法，所述方法包括：
(a)将第一传感器插入所述组织块内或/和所述组织块旁；
(b)计算围绕所述组织块的切割边缘；
(c)将手术设备插入所述患者内，所述手术设备联接第二传感器；
(d)相对所述切割边缘追踪所述第二传感器；和
(e)使用手术设备切割切割边缘。
26.如权利要求25所述的方法，其中所述第一传感器传输信号，所述信号指示组织块相对手术设备的实时位置和方向。
27.如权利要求25所述的方法，其中所述第一传感器嵌入钩结构，所述钩结构的尺寸契合内置于以下至少其一：递送针和套管；
其中所述递送针和所述套管中的至少一个设置成引导所述第一传感器，而所述钩结构设置成将所述第一传感器锚固于组织块内。
28.如权利要求25所述的方法，其中嵌入所述钩结构的所述第一传感器在实时成像导引下插入所述组织块。
29.如权利要求25所述的方法，其中所述第一传感器嵌入钩结构，所述钩结构包括多个尖头，并且其尺寸契合内置于以下至少其一：递送针和套管；
其中所述递送针和所述套管中的至少一个设置成引导所述第一传感器，而所述多个尖头设置成将所述第一传感器锚固于组织块内。
30.如权利要求29所述的系统，其中所述钩结构还包含由所述钩结构的管部分延伸的多个延伸部分，所述多个延伸部分的尺寸能收纳所述第一传感器。
31.如权利要求25所述的方法，其中所述第一传感器是基准标记物，所述基准标记物包括超弹性材料。
32.如权利要求25所述的方法，其中所述组织块为肿瘤、结节和病灶中的至少一种。
33.如权利要求25所述的方法，其中所述手术设备为吻合器、波维笔和切割装置中的至少一种。
34.如权利要求25所述的方法，其中所述第二传感器以与所述第一传感器相同的参照指示所述手术设备的位置和方向。
35.如权利要求25所述的方法，其还包括：
提供控制器，其设置成执行存有的程序，以计算所述第一传感器和所述第二传感器之间的距离；和
将所述第一传感器和所述第二传感器之间的距离显示于显示器，所述显示器联接所述手术设备。
36.如权利要求35所述的方法，其中所述存有的程序是导航系统。
37.如权利要求35所述的方法，其中所述存有的程序包括形变算法。
38.如权利要求35所述的方法，其中所述显示器是OLED和LCD显示器中的至少一种。
39.如权利要求35所述的方法，其还包括：
由声源发射声音信号，所述声源与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述声音信号。
40.如权利要求35所述的方法，其还包括：
在监视器上发射视觉信号，所述监视器与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述视觉信号。
41.如权利要求35所述的方法，其还包括：
在监视器上显示视频覆盖图，所述监视器与所述控制器连通，所述控制器设置成执行存有的程序，以将腹腔镜图像融合到虚拟内窥镜图像来生成所述视频覆盖图；
其中所述视频覆盖图设置成鉴定所述组织块和所述第一传感器的位置。
42.如权利要求35所述的方法，其还包括：
用于发射触觉信号的压电致动器，所述压电致动器与所述控制器连通，所述控制器设置成执行存有的程序，以根据所述第一传感器和所述第二传感器之间的距离改变所述触觉信号。
43.如权利要求42所述的方法，其中所述压电致动器联接手术设备的手柄。
44.如权利要求25所述的方法，其中所述第一传感器是基准传感器，而所述第二传感器是设备传感器；
其中所述第一传感器设置成测量所述组织块的位置和方向，而所述第二传感器设置成测量所述手术设备的位置和方向。
45.如权利要求25所述的方法，其中所述第二传感器通过粘合剂联接手术设备的壳体。
CN201780029014.8A 2013-09-06 2017-03-10 用于组织切割边缘测量装置的系统和方法 Pending CN109152550A (zh)

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