CN105228518B - 用于诊断冠状微脉管疾病的系统和方法 - Google Patents

用于诊断冠状微脉管疾病的系统和方法 Download PDF

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CN105228518B
CN105228518B CN201480014244.3A CN201480014244A CN105228518B CN 105228518 B CN105228518 B CN 105228518B CN 201480014244 A CN201480014244 A CN 201480014244A CN 105228518 B CN105228518 B CN 105228518B
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D·柯林斯
M·L·加迪斯
N·J·肯普
B·斯图姆
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Abstract

本发明提供了一种用于评估对象的脉管系统的系统和方法。在特定的方面中，本发明的系统和方法涉及：经由与不透辐射标签共同配准的数据收集器来接收对象的功能流数据、接收包括所述不透辐射标签的所述脉管系统的成像数据、生成与所述功能流数据相对应的脉管系统图、并且在监视器上显示所述脉管系统图图像。

Description

用于诊断冠状微脉管疾病的系统和方法
相关申请的交叉引用
本申请要求享有2013年3月12日递交的美国临时专利申请序列号61/776863的优先权，在此通过引用将其内容整体并入本文。
技术领域
本申请总体上涉及用于评估对象的脉管系统的系统和方法。
背景技术
冠状微脉管疾病，又称小血管疾病，是心脏中的小动脉变窄的病况。典型地，小动脉的壁受损或患病。冠状微血管疾病以与传统冠状动脉疾病不同的方式影响血管。冠状动脉疾病是由于血小板累积以及因累积的血小板形成的血液凝块对通过冠状动脉的血流的阻塞。然而，血小板的累积以及作为结果的障碍并不总是存在于冠状微脉管系统疾病中。相反，冠状微脉管系统疾病是由小血管的不良收缩/松弛引起的。这种不良收缩/松弛被认为是由动脉细胞及周围肌肉组织的变化引起的。冠状微脉管疾病在女性中尤其成问题，她们相对于男性更容易患此疾病。
诊断冠状微脉管疾病一直是困难的。常规的方法(例如血管造影术、应激测试、以及心脏MRI应激测试等)被设计为检测动脉中的障碍。这些测试不能够一致地诊断冠状微脉管疾病，这是因为小的患病血管常常不受血小板限制，并且因此在血管造影图和MRI扫描上不可见。因此，正经历不可解释的疲劳、胸痛，或与心脏病相关联的全身不适的女性及其他易感人群(例如糖尿病患者)可能针对心脏病而被测试为阴性。
发明内容
本发明通过将一个或多个功能流测量结果映射到脉管系统的图像来克服用于检测冠状微脉管疾病的常规方法限制。功能流测量允许通过监测血流速度和压力来确定血管的异常收缩或松弛，甚至是在没有狭窄的情况下。当功能流测量结果被映射或共同配准到脉管系统图像时，可以确定在其他方式中不在通过外部成像模态获得的脉管系统图像中被指示的受损血管的位置和严重性。
本发明的方法是通过利用与不透辐射标签共同定位的数据收集器接收对象的功能流数据并接收包括所述不透辐射标签的脉管系统的成像数据来实现的。使用接收到的功能流数据和成像数据生成并在监视器上显示与所述功能流数据相对应的脉管系统图图像。在特定的实施例中，与所述功能流数据相对应的所述脉管系统图图像是通过将所述功能流数据与所述成像数据共同配准来生成的。通过将不透辐射标签与所述数据收集器共同定位，更容易识别所述数据收集器的确切位置，并使给出的功能流测量结果与所述脉管系统内的具体位置相关。这使得能够同时显示功能流测量结果并指出那些功能流测量结果在对应的脉管系统图图像上的位置。
本发明的方法还提供了显示包括所述脉管系统图图像和功能流图像的合成图像。所述功能流图像可以包括特定于如所述脉管系统图图像上示出的所述脉管系统中的特定位置的所述功能流测量结果。所述脉管系统图图像可以示出所述数据收集器的位置，所述位置直接与所显示的功能流图像相对应。在一些实施例中，所述数据收集器的所述位置是所述数据收集器的实时位置，例如所述数据收集器在被插入所述脉管系统中时的当前位置。
根据特定的方面，本发明的方法还包括针对一个或多个参数对所述功能流数据进行分析，并且当所述一个或多个参数在阈值水平处或超过阈值水平时在所述脉管系统图图像上提供警告。在特定的实施例中，所述警告是视觉警告。所述视觉警告可以包括颜色编码的指示符、闪烁指示符、所述一个或多个参数的彩图、调出标志物、或它们的组合。
所述数据收集器可以被定位在导丝、导管或被配置为进入所述脉管系统的其他腔内设备上。典型地，用于获得功能流数据的所述数据收集器是压力传感器、流量传感器、或它们的组合。优选地，所述腔内设备是在所述设备的远端部分上具有压力传感器和流量传感器两者的导丝。压力传感器能够获得压力测量结果，并且流量传感器能够获得血管内的速度测量结果。对压力和流量两者进行测量和比较的能力显著改善了对缺血性测试的诊断准确性。
可以使用任意外部成像模态来获得所述成像数据，包括例如计算机断层摄影、血管造影术以及磁共振成像。当所述外部成像模态要求流量造影时，所述流量造影可能不以用于正确成像的足够的量来进入所述脉管系统的所有血管(例如与冠状微脉管系统疾病相关联的小血管)，这可以防止对没有造影的血管的映射。因此，所使用的外部成像模态优选地不要求用于成像的流量造影，以增加与冠状微脉管系统疾病相关联的小血管被成像并被映射的可能性。
附图说明
图1是用于实施对功能流数据与外部成像数据的共同配准的系统的示意性图示。
图2示出了对根据特定实施例的通过外部成像模态获得的背景脉管系统图像图的描绘。
图3描绘了示出与功能流数据相对应的脉管系统图图像与功能流图像的合成图像。
图4描绘了对功能流图像和脉管系统图图像的同时显示，经由方框突出显示了在其中获得功能流图像数据的位置。
图5描绘了对功能流图像和脉管系统图图像的备选的同时显示，突出显示了在其中获得功能流图像数据的位置。
图6指示了根据特定实施例的警告。如果来自在该位置处的功能流数据的一个或多个参数在针对该一个或多个参数的阈值水平处或超过该阈值水平，则为指示数据收集器位置的箭头和将功能流图像以视觉方式联系到该位置的线给出不同颜色。
图7示出了针对参数的脉管系统图像图的彩图。
图8是同时示出与来自图7的点X相对应的功能流图像的图像。
图9A-图9B示出了对脉管系统图像图上的调出标志物的使用，以表示脉管系统的与功能流数据相对应的感兴趣区域。
图10示范了适合于与本发明一起使用的导丝。
图11是本发明的用于对功能流数据相对于对象的脉管系统的图像的位置进行定位的系统的方框图。
图12是用于对功能流数据相对于对象的脉管系统的图像的位置进行定位的网络化系统的方框图。
具体实施方式
本发明的方法和系统包括功能流数据和图像数据采集装备，以及数据/图像处理器，所述数据/图像处理器在单个显示器上生成视图，所述单个显示器同时与数据收集器(例如压力传感器、流量传感器、温度传感器或它们的组合)相关联的位置信息和功能流数据。数据收集器被安装在柔性细长构件(例如导管、导丝等)上，并且与能够利用外部成像模态跟踪的不透辐射标签共同定位。
首先转到图1，示意性地描绘了用于以对从外部成像模态获得的成像数据与从数据收集器获得的功能流数据进行共同配准的形式执行本发明的示范性系统。外部成像模态数据和功能流数据采集子系统一般是本领域周知的。关于外部成像模态数据，患者10被定为在台面12上以用于成像。台面12被布置为提供足够的空间用于将外部成像模态14定位在相对于台面12上的患者10的操作位置中。通过外部成像模态14采集的成像数据经由传输线缆16传到外部成像模态处理器18。成像模态处理器18将经由线缆16接收到的所接收的成像数据转化成脉管系统图像数据。脉管系统图像数据最初被存储在处理器18内。
关于系统的与采集功能流数据相关联的部分，功能流设备20(优选地是压力导丝、流量导丝，或组合的压力/流量导丝)被插入患者10内，从而使其包括数据收集器22(例如压力传感器、流量传感器、或两者)的远端部分在脉管系统的期望区域的附近。尽管未在图1中特别地认定，但靠近数据收集器22被定位的不透辐射标签提供了对数据收集器22在外部图像中的当前位置的标识。通过范例，数据收集器22可以是对压力梯度做出响应并将压力转化成对应的电信号的晶体半导体材料。将对应的电信号沿功能流设备20的长度传输到近端连接器24。数据收集器可以作用为关于功能流设备的各种配置。无论配置如何，不透辐射标签都应与数据收集器共同定位，即被靠近数据收集器在数据收集器处放置。在一些实例中，数据收集器本身可以包括不透辐射的材料。
功能流设备20的近端连接器24被可通信地耦合到功能流数据处理器26。功能流数据处理器26将经由近端连接器24接收到的信号转化成例如压力测量结果、流量测量结果、血流储备分数测量结果、冠状动脉血流储备测量结果等。额外地，功能流处理器26通过将功能流数据转化成可显示的格式来生成功能流图像。由功能流处理器26绘制的功能流数据最初被存储在处理器26内。
根据本发明的备选实施例，由数据收集器22采集并由功能流处理器26处理的诊断功能流数据的类型是变化的。根据具体实施例，诊断探头22被装备有用于提供又被称为功能流数据的血液动力学信息(例如血流速度和压力)的一个或多个传感器(例如多普勒流量和/或压力)。因此指出，术语“功能流图像”旨在被宽泛地解释为包括表示脉管信息的各种方式，所述脉管信息包括血压、血流速度/体积、血管横截面构造、在血液上的剪切应力、在血液/血管壁界面处的剪切应力等。在采集针对血管的特定部分的血液动力学数据的情况下，有效的诊断依赖于在同时观察指示心血管疾病的功能流量度的同时将数据收集器22在脉管系统内的当前位置可视化的能力。对血液动力学图像与外部脉管系统图像的共同配准有助于对患病血管的精确处置。此外，预期功能流设备包括一个或多个成像收集器，以与功能流数据一起提供例如脉管系统的横截面图像。由成像收集器获得的数据也可以由功能流处理器26来处理，并与外部成像数据进行共同配准。
共同配准处理器30经由线32接收来自功能流处理器26的功能流数据，并且经由线34接收来自外部成像模态处理器18的脉管系统图像数据。备选地，传感器与处理器之间的通信是经由无线介质来执行的。共同配准处理器30绘制了与功能流数据相对应的脉管系统图图像。例如，脉管系统图图像被提供为示出数据收集器在脉管系统内的位置，例如，如由不透辐射标签指示的位置。根据本发明的实施例，标识(例如不透辐射标志物伪影)被提供在与同时显示的功能流图像相对应的位置的脉管系统图图像上。在优选的实施例中，软件标注提供其他视觉标识(例如调出标志物、方框、箭头或其他计算图标)，以示出不透辐射标志物伪影。在一个实施例中，显示合成图像，示出具有标识的脉管系统图图像以及特定于脉管系统图图像中的所述标示的位置的功能流数据图像。脉管系统图图像和功能流图像可以被同时显示在监视器上，或者通过经由用户界面将脉管系统图图像或功能流图像最小化或最大化来将每个独立地显示在监视器上。
共同配准处理器30首先将经由线34从外部成像模态处理器18接收到的外部成像数据缓存在图像数据存储器40的第一部分36中。这提供了初始背景脉管系统图图像，其能够利用时间戳脉管系统图图像帧来更新。其后，在导管插入流程的过程期间，分别经由线32和34接收到的功能流数据和脉管系统图图像数据被分别存储在图像数据存储器40的第二部分38和第三部分42内。被存储的图像数据的独立绘制的帧被适当地标注(例如时间戳、序列号等)，以使功能流数据帧与对应的脉管系统图(包括不透辐射标志物标识)图像数据帧相关。与特定的脉管系统图像图帧相对应的所存储的功能流数据帧能够被用于跟踪脉管系统内的各个位置上的功能流数据。在特定的实施例中，在脉管系统图图像上提供警告，该警告指示由数据收集器在脉管系统中的各个位置处获得的功能流数据的水平。
此外，额外的标志物能够被放置在患者的表面上或外部成像模态设备的视场内的患者的附近。这些标志物的位置接着被用于将血管造影图像上的不透辐射标签定位在准确位置中。
共同配准处理器30根据先前存储在图像数据存储器40的第一部分36、第二部分38和第三部分42内的数据来绘制共同配准图像。通过范例，从第二部分38中选择功能流数据帧。共同配准处理器30识别第三部分42内与来自第二部分38的选定的功能流数据帧相对应的脉管系统图图像帧。其后，共同配准处理器30将来自第三部分42的脉管系统图图像帧重叠在从第一部分36检索出的初始脉管系统图图像上。此外，可以处理功能流数据以根据功能流数据来确定临床相关测量结果，例如血流储备分数测量结果、冠状动脉血流储备测量结果、组合的P-V曲线，并且在功能流图像中例如与压力和流量读数一起显示那些测量结果。其后，可以将经共同配准的脉管系统图图像和功能流图像互相并排地同时显示在图形显示设备50上。驱动显示设备50的功能流数据帧和经共同配准的图像也被存储在长期存储设备60上，以供在与对存储在图像数据存储器40中的脉管系统图像数据和功能流数据进行采集的流程分开的阶段中的稍后复审。
尽管未在图1中示出，拉回设备可以可操作地与功能流设备相关联，所述来回设备以受控的/被测的方式移动来自患者的功能流20。这样的设备在本领域中是周知的。对这样的设备的并入有助于在外部成像模态不主动提供成像数据时的时间点处计算数据收集器22在视场内的当前位置。例如，如果血管造影术/荧光检查被用作外部成像模态，则拉回机构能够被用于在荧光检查不起作用时跟踪数据收集器在初始背景脉管系统图图像上的位置。
图2-图4图示了用于将脉管系统的功能流数据映射到通过外部成像模态获得的脉管系统成像数据的示范性技术。
转到图2，外部成像模态处理器18以期望的投影(患者/血管取向)和放大捕捉初始背景脉管系统图图像200。通过范例，首先在跟踪功能流设备到患者的脉管系统内的感兴趣区域之前通过外部成像模态来捕捉初始图像200。尽管如此，也可以在所述流程期间捕捉背景脉管系统图图像。初始图像200提供示出脉管系统的血管210。
转到图3，示范性共同配准显示器401(包括相关的脉管系统图图像和功能流数据图像)描绘了包含功能流测量结果的功能流图像和与数据收集器的位置有关的数据。脉管系统图图像410被与功能流图像400同时并排地显示在显示器50上。脉管系统图图像410包括不透辐射标签420，所述脉管系统图图像410是根据由脉管系统图像帧绘制的外部成像数据而生成的，被重叠在根据存储器40的第一部分36绘制的背景图像上。脉管系统图像帧与数据收集器22在被观察的血管内的当前位置相对应。对被表示在背景脉管系统图像与在流程期间收集到的脉管系统图图像帧两者中的视场的精确匹配(即对两幅图像的精确投影和放大)允许对数据收集器的与图3中显示的共同配准图像的右边的显示出功能流图像400相对应的当前位置的识别。
在一些实施例中，图像标注软件能够被用于自动识别不透辐射标签的位置，所述不透辐射标签可以呈现为具有比图像的剩余部分更深的颜色的小斑点。图像标注软件能够自动地在脉管系统图图像上定位与数据收集器的位置相对应的方框，例如如图4所示。使用这样的系统的医生将能够定位特定的感兴趣结构，并较轻松地返回到那些结构。因此，流程将花费较少时间，并且患者和医生将被暴露于较少的辐射。在针对脉管系统的区域获得了功能流数据之后，医生仅需要在脉管系统图图像上点击该区域内的位置来取出与该位置相对应的功能流图像。
除了以上所描述的实施例，如图5所示，本发明的设备、方法和系统还能够被用于对脉管内成像与脉管结构的交叠图像进行编制目录和显示。使用图像标注软件或其他算法，还可能显示将脉管内图像进行共同显示的脉管系统图图像。图5示出了在肺动脉的脉管系统图图像上与数据收集的位置共同定位的模拟功能流图像。
该系统在生成/采集脉管系统的外部图像数据(例如放射学的)和功能流数据时还考虑心脏运动。通过范例，通过仅在EKG的峰值R-波期间采集针对脉管系统图的图像数据，心脏运动是小得多的因素，并且在血管造影图与荧光检查视场之间存在良好的叠加相关性。选择峰值R-波是因为其表示舒张末期，心脏在所述舒张末期期间具有最小的运动量，并且因此具有获得外部图像数据的更一致的条件。峰值R-波也是EKG中系统易于检测的点。
继续参考图3，在示范性实施例中，当功能流设备20开始收集数据时，功能流数据被串列地显示，其中增强的脉管系统图410包括背景脉管系统图图像和重叠的脉管系统图帧两者。增强的脉管系统图图像410和功能流数据400被彼此靠近地(例如并排)显示在显示器50上，使得操作者能够集中在横截面图像400中的信息上，同时几乎同时地观察增强的放射学图像410的状态。
对具有脉管系统图的合成图像和功能流数据两者的同时显示允许即时知道血管段的疾病状态和血管段在患者内的位置两者。这样的综合信息在用于评估心血管疾病的常规方法中不能容易地辨别。此外，功能流测量结果允许识别单独在脉管系统图像中不容易看到的缺陷和病况，例如微脉管系统疾病的症状。飞行浏览和堆叠的图像都不能单独地允许以下的同时鉴别：1)横截面中的信息的全部、2)对血管的形状的感知、以及3)横截面沿血管的长度的位置。
以上所描述的对包括不透辐射标签的脉管系统图图像与功能流图像/信息的“共同配准”在一个展示中将全部这三项直接传递给具有即使是平均视觉和空间能力的操作者。通过范例，在流程发生的房间里或者在远程位置中，共同配准显示被呈现在功能流设备的控制台显示器上，或者共配准显示被呈现在一个或多个外部成像模态监视器上。例如，在流程房间中的台面上的一个监视器允许主治医生查看流程，同时针对该情况并不精通的第二咨询医生也能够从单独的控制室经由包含共同配准显示的第二监视器查看该情况。控制室查看也可能无需穿戴含铅覆盖物。
关于增强的脉管系统图图像410(包括不透辐射标签)的背景脉管系统图图像部分的持续性，通过范例，针对给定的流程/患者位置来获得/生成单个初始图像，并将其存储在存储器40的第一部分36中。如果视场改变或患者的位置改变，则生成经更新的背景脉管系统图像并将其存储在第一部分36中。备选地，背景脉管系统图图像是实况的或连续更新的。路线图脉管系统图图像到增强的脉管系统图像410上的投影优选地为这样的取向和放大，即所述取向和放大考虑到在曲折/蜿蜒的血管中存在的透视缩短而最佳地显示出要查看的整个血管。备选地，能够使用/显示两幅背景脉管系统图像(或者甚至两幅增强的放射学图像410)来代替一幅图像410。
根据特定的方面，本发明的系统和方法提供了针对一个或多个参数来分析功能流数据，并且当所述一个或多个参数超过阈值水平时在脉管系统图图像上提供警告。阈值水平可以被建立为阐明指示狭窄、血管收缩或其他血管损伤的可接受数据范围。例如，可以针对参数建立阈值水平，以将该参数分类为正常的或异常的。此外，可以针对正常与异常之间的中间范围建立阈值水平。在一个实施例中，功能流数据的参数包括针对冠状动脉血流储备、血流储备分数、压力-体积(P-V)曲线/循环、或它们的组合的水平。
冠状动脉血流储备被定义为充血的最大冠状动脉血流与正常流量的比率。冠状动脉血流储备表示心肌响应于最大锻炼增加血流的能力。为2或超过2的比率被认为是正常的。异常CFR(低于2的比率)指示狭窄、微动脉的异常收缩、或全部两者。冠状动脉血流储备测量流的速度。血流储备分数测量在血管的部分上的压力差，以确定血管的收缩或狭窄的水平是否将妨碍到心脏肌肉的氧递送。特别地，血流储备分数是在被检查的血管的部分的远端的压力水平与在被检查的血管的部分的近端的压力水平的比率。通常使用0.75至0.80的截断点，其中高的值指示不显著的狭窄或收缩，并且较低的值指示显著的狭窄和病灶。
P-V循环提供了用于理解心脏机制的框架。能够通过对左心室内的压力和体积的实时测量来生成这样的循环。能够根据这些循环来确定几个生理相关的血液动力学参数，例如心搏量、心脏输出、射血分数、心肌收缩力等。为了生成针对左心室的P-V循环，在单次心脏周期期间的多个时间点处绘制LV压力对LV体积的曲线图。狭窄或收缩的存在使P-V循环的曲线/形状从正常的P-V循环发生改变。
已经示出，远端压力和速度测量结果，尤其是关于压降-速度关系(例如血流储备分数(FFR)、冠状动脉血流储备(CFR)以及组合的P-V曲线)揭示了关于狭窄严重性的信息。例如，在使用中，功能流设备可以前进到狭窄的远端侧的位置。接着可以在第一流动状态中测量压力和流速。然后，可以例如通过使用药物(例如腺苷)来使流率显著增大，并在这种第二充血流动状态中测量压力和流量。然后对这两个流动状态中的压力和流量关系进行比较，以评估狭窄的严重性并提供针对任何冠状动脉介入的经改进的引导。利用组合的压力/流量导丝在相同位置和相同时间取得压力和流量测量结果的能力提高了这些压力-速度循环的准确性，并因此提高了诊断信息的准确性。
冠状动脉血流储备、血流储备分数以及P-V循环可能要求在动脉中的不同位置处取得测量结果。为了提供针对这些参数的测量结果，本发明的系统和方法可以相对于数据收集器在脉管系统内的第二位置处的压力和流量来评估在数据收集器的第一位置处的压力和流量。例如，第一位置是被检查的血管的段的远端，并且第二位置是血管的该段的近端。接着相对于一个或多个阈值水平来评估在两个位置上获得的测量结果，并且当一个或多个参数在阈值水平处或超过阈值水平时在脉管系统图像图上提供警告。例如可以针对数据收集器在脉管系统图图像上与一个或多个参数相对应的单个位置来指示警告，或者可以针对数据收集器的与多个参数相对应的若干位置来指示警告，或者可以在脉管系统图像图上数据收集器的与单个参数相对应的一个或多个位置点上指示警告。
在一些实施例中，警告是颜色编码的指示符、闪烁指示符、一个或多个参数的彩图、调出标志物、或它们的组合。如果与脉管系统图像图上的一个或多个位置相对应的功能流数据超过阈值水平或在阈值水平处，则在该一个或多个位置处提供警告。本文中预期被用于指示脉管系统图图像上的感兴趣区域的警告的任意组合。在一个范例中，警告是颜色编码的调出标志物。在另一范例中，警告是具有调出标志物的彩图。图6-图9B指示了根据特定实施例的对警告的使用。
如图6所示，如果来自数据收集器的位置处的功能流数据的一个或多个参数在针对该一个或多个参数的阈值水平处或超过所述阈值水平，则对指示该位置的箭头和将功能流图像以视觉方式联系到该位置的线给出不同的颜色。例如，如果功能流数据指示例如在脉管系统中的该具体位置处不存在异常血管收缩或狭窄，则图6中的箭头和联系线可以是绿色。备选地，红色可以被用于指示在脉管系统中的该具体位置处的异常血管收缩或狭窄。在另一实施例中，作为对被用于指示收缩或狭窄的水平的颜色的替代或与其组合，箭头和/或联系线可以闪烁，以指示收缩或狭窄的水平。在其他范例中，功能流图像本身可以闪烁，以指示测量结果在阈值水平处或超过阈值水平。
图7示出了针对参数的脉管系统图像图的彩图。如图7所示，脉管系统的区域被标记为A、B和C。这些区域基于对与这些区域相对应的功能流数据的测量结果来指示脉管系统的不同颜色。对于彩图，区域A可以是绿色的以指示该区域具有正常的功能流数据测量结果；区域B可以是黄色的以指示该区域具有中间的功能流数据测量结果(健康与异常之间的边界线)，并且区域C可以是红色的以指示该区域具有异常的流数据测量结果。结果，使用本发明的系统的医生仅需要看脉管系统图图像来快速地指出脉管系统中的感兴趣区域。此外，医生仅需要在脉管系统图的彩图区域内的位置上进行点击来取出与该位置相对应的功能流图像数据。例如，如果医生在点X上进行点击，则图8将出现为同时示出与点X相对应的功能流图像。
图9A-图9B示出了调出标志物在脉管系统图像图上的使用，以表示脉管系统的与功能流数据相对应的感兴趣区域。如所讨论的，感兴趣区域可以是这样的位置，即在所述位置处的功能流数据的参数在阈值水平处或超过阈值水平。在点击了调出标志物中的一个之后，与脉管系统的该位置相关联的功能流图像将出现，例如图9B。在特定的实施例中，可以在阶段期间在多个调出标志物上进行点击，以对与调出标志物相对应的功能流图像进行比较。
适合于在本发明的方法和系统中使用的功能流设备可以是导丝或导管。优选地，功能流设备是大小被调整为适合在微脉管血管的内部内的导丝。示范性的导丝包括Volcano公司的FloWire多普勒导丝和ComboWire XT导丝。
图10描绘了适合于在本发明的方法和系统中使用的导丝5。导丝5包括具有近端部分102和远端部分104的柔性细长构件100。导丝5可以具有0.018"和更小的平均直径。柔性细长构件100典型地包括细长轴116和线圈段112。柔性细长轴116能够由任何适合的材料形成，例如不锈钢、镍钛合金(镍钛诺)、聚酰亚胺、聚醚醚酮、或者其他金属或聚合物材料，并且具有适合的壁厚度，例如0.001"至0.002"。该柔性细长轴通常被称作海波管(hypotube)。在一个实施例中，海波管可以具有130至170cm的长度。导丝还包括被设置在细长构件100的腔内的芯构件150。芯构件150从柔性细长构件100的近端部分延伸到远端部分，以提供期望的扭转属性，从而帮助在血管中对导丝的操纵并且为导丝提供强度并防止扭结。芯构件能够由适合的材料形成，例如不锈钢、镍钛合金(镍钛诺)、聚酰亚胺、聚醚醚酮、或者其他金属或聚合物材料。
芯构件150的近端部可以被连接到手柄。芯构件150的近端部能够被可移除地耦合到连接器外壳106。除了接收芯构件150的近部，连接器外壳106还可以可移除地连接到并接收一条或多条电连接线(未示出)，所述一条或多条电连接线沿细长体100的长度延伸并连接到远端部分102上的一个或多个传感器。这种可移除的连接允许在将导管放置在导丝上时将导丝从连接器外壳106断开，并在其后重新连接导丝以检验到传感器的电通信。连接器外壳106可以包括与电导体线配合的一个或多个电连接。连接器外壳106可以经由线缆108而被连接到输出连接器72。输出连接器72可以是图1中示出的近端连接器24，或者被耦合到图1中示出的近端连接器24。近端连接器24将信号从一个或多个传感器传输到图1的功能流数据处理器26。
传感器外壳120可以被定位在细长构件100上。传感器外壳120包括限定腔的壳体。一个或多个洞可以被成形在传感器外壳的壁中，以形成对于被设置或安装在其中的传感器的窗口。传感器外壳优选地被定位在线圈段112与远端尖端110之间。传感器外壳120包含被配置为接收功能流数据并将功能流数据传输到功能流处理器26的一个或多个数据收集器。
适合于在本发明的方法和设备中使用的数据收集器包括例如压力传感器、流量传感器、或它们的组合。数据收集器与不透辐射标签共同定位，使得能够确定功能流数据的位置。
压力传感器允许获得身体腔内的压力测量结果。压力传感器的具体益处在于，压力传感器允许测量血管中的FFR。FFR是对在狭窄之前的位置和狭窄之后位置处的血管内的压力的比较。FFR的水平确定了狭窄的显著性，这允许医生更准确地识别临床相关的狭窄。例如，超过0.80的FFR测量结果指示正常的冠状动脉血液流量和非显著的狭窄。另一益处在于，医生能够测量在腔内介入流程之前和之后的压力，以确定流程的影响。
压力传感器能够被安装在柔性细长构件的远端部分上。在特定的实施例中，压力传感器被定位在细长构件的可压缩且可弯曲的线圈段的远端。这允许压力传感器在被弯曲时与线圈段一起移动并远离纵轴。压力传感器能够由在其中具有凹陷并形成与边缘接壤的隔膜的晶体半导体材料形成。加强构件被结合到晶体并加强晶体的边缘，并且在其中具有在隔膜下方并且被暴露于隔膜的洞。具有相对端的电阻器由晶体承载并且具有其对隔膜的部分进行覆盖的部分。电导体线能够被连接到电阻器的相对端，并且在柔性细长构件内延伸到柔性细长构件的近端部分。美国专利No.6106476中描述了可以与本发明的设备一起使用的适合的压力传感器的额外细节。美国专利No.6106476还描述了用于将压力传感器104安装在传感器外壳内的适合的方法。
流量传感器能够被用于测量血管内的血流速度，所述血流速度能够被用于评估冠状动脉血流储备(CFR)。例如，流量传感器能够是被设置在导丝的远端尖端处或非常接近导丝的远端尖端的超声换能器、多普勒流量传感器、或任何其他适合的流量传感器。超声换能器可以是任意适合的换能器，并且可以使用任意常规方法(包括在美国专利No.5125137、6551250和5873835中描述的方式)被安装在远端。
在本发明的方法和设备中使用的外部成像模态设备包括例如X-射线血管造影成像、计算机断层摄影成像、以及磁共振成像设备。优选地，成像模态是不需要使用造影的计算机断层摄影，造影可能不以针对正确成像的足够的量进入微脉管系统的小血管或狭窄血管。
本发明的系统可以被实现为多种格式。图11中示出了本发明的系统300的实施例。系统300的核心是计算机360或包括处理器365和存储器367的其他计算布置(见图12)。存储器具有指令，所述指令在被运行时令处理器接收利用与不透辐射标签共同定位的图像收集器收集到的对象的脉管系统的成像数据。脉管系统的功能流数据典型地源于与功能流设备325电子通信和/或机械通信的数据收集器320。存储器额外地具有在被运行时令处理器接收包括不透辐射标签的对象的图像的指令。对象的图像典型地是X射线图像，例如在血管造影、CT扫描、MRI扫描期间产生的图像。对象的图像典型地源于与放射学源343和放射学图像收集器347(例如平板探测器)电子通信和/或机械通信的外部成像设备340。已经收集到图像之后，处理器接着处理器图像，并输出示出数据收集器320的位置的对象的图像以及对象的脉管系统的图像。图像典型地被输出到要由医生或技师查看的显示器380。在一些实施例中，例如图3-图5所示，显示的图像同时包括功能流图像和脉管系统的图像两者。
在先进的实施例中，系统300可以包括成像引擎370，所述成像引擎370具有先进的图像处理特征(例如图像标注)，所述先进的图像处理特征允许系统300更有效地处理并显示组合的功能流图像和脉管系统图图像。成像引擎370可以自动突出显示或以其他方式标记出脉管系统中的感兴趣区域。成像引擎370也可以产生对脉管系统图图像的3D绘制。在一些实施例中，成像引擎370可以额外地包括数据采集功能(DAQ)375，所述数据采集功能(DAQ)375允许成像引擎370直接从功能流设备325或收集器347接收要被处理成用于显示的图像的成像数据。
其他先进的实施例使用计算机360的I/O功能362，以控制脉管内成像320或外部成像模态340。在这些实施例中，例如在功能流设备325是拉回型的情况下，计算机360可以令功能流设备325的数据收集器行进到特定位置。计算机360也可以令源343对场进行辐照，以获得脉管系统的刷新的图像，或者清除收集器343的最近的图像。尽管未在这里示出，也可能计算机360可以控制被连接到功能流设备325的操纵器(例如机械手操纵器)来改进对功能流设备325的放置。
如图12所示，也可以在经由网络409通信的多个独立平台上实现本发明的系统400。能够使用软件、硬件、固件、硬接线或这些中的任意的组合来执行本发明的方法。也能够将特征实现功能物理地定位在各个位置处，包括被分布使得在不同的物理位置处实现功能的部分(例如成像装置在一个房间中而主工作站在另一房间中，或者在例如具有无线或有线连接的分开的建筑物中)。
如图12所示，功能流数据收集器320和外部成像模态340是获得数据的关键，然而能够由以经由网络409(例如局域网、无线网络或互联网)的通信工作的多个处理器来执行对用于数据收集、数据的共同配准、存储和数据输出的步骤的实际实现。系统400的部件也可以是物理上分开的。例如，终端467和显示器380可以在地理上不与功能流数据收集器320和外部成像模态340定位一起。
如图12所示，成像引擎859通过网络409与主工作站433以及任选的服务器(未示出)通信。在一些实施例中，操作者使用主工作站433、计算机360或终端467来控制系统400或接收图像和功能流数据。可以使用可以包括监视器的I/O 362、437或471来显示图像。任何I/O都可以包括监视器、键盘、鼠标或触摸屏，以与处理器365、441或475中的任何处理器通信，例如以令数据被存储在任意有形的非瞬态存储器367、445或479中。服务器一般包括接口模块以通过网络409通信或将数据写入数据文件。来自用户的输入由电子设备(例如主工作站433、终端467或计算机360)中的处理器接收。在某些实施例中，主工作站433和成像引擎855被包括在床旁控制台中，以操作系统400。
在一些实施例中，系统可以绘制对脉管系统或脉管内图像的三维成像。诸如主工作站433的系统内的电子装置(例如PC、专用硬件、或固件)将三维图像存储在有形的非瞬态存储器中，并且在显示器380上绘制3D组织的图像。在一些实施例中，如之前所讨论的，3D图像将被编码以用于更快地查看。在特定的实施例中，本发明的系统利用元素或控件来绘制GUI，以允许操作者与三维数据集(如三维视图)进行交互。在其他实施例中，操作者可以在动态进度视图被显示在显示器中的同时，通过选择开始和停止点来从图像中的一个或三维数据集内选择点。在其他实施例中，用户可以通过与脉管系统图图像进行交互来令功能流设备被重新定位到身体中的新的位置。
在一些实施例中，用户与视觉界面进行交互并输入参数或做出选择。由电子设备(例如工作站433、终端467或计算机360)中的处理器接收来自用户的输入(例如参数或选择)。选择能够被绘制成可见显示。在一些实施例中，操作者使用主工作站433、计算机360或终端467来控制系统400或接收图像。可以使用可以包括监视器的I/O 362、437或471来显示图像。任何I/O都可以包括键盘、鼠标或触摸屏，以与处理器365、441或475中的任何处理器通信，例如从而令数据被存储在任何有形的非瞬态存储器367、445或479中。服务器一般包括接口模块，以通过网络实行通信或将数据写入到数据文件。能够使用软件、硬件、固件、硬接线或这些中的任意的组合来执行本发明的方法。也能够将特征实现功能物理地定位在各个位置处，包括被分布使得在不同的物理位置处实现功能的部分(例如成像装置在一个房间中而主工作站在另一房间中，或者在例如具有无线或有线连接的分开的建筑物中)。在特定的实施例中，主工作站433和成像引擎855被包括在床旁控制台单元中以操作系统400。
通过范例，适合于对计算机程序的运行的处理器包括通用微处理器或专用微处理器两者，以及任意种类的数字计算机的任意一个或多个处理器。一般地，处理器将接收来自只读存储器或随机存取存储器或两者的指令和数据。计算机的必需元件是用于运行指令的处理器和用于存储指令和数据的一个或多个存储器设备。一般地，计算机还将包括或能被耦合为从用于存储数据的一个或多个大容量存储设备(例如磁盘、磁光盘或光盘)接收数据或将数据传输到一个或多个大容量存储设备，或两者。适合于体现计算机程序指令和数据的信息载体包括所有形式的非易失性存储器，例如包括半导体存储器设备(例如EPROM、EEPROM、基于NAND的闪存、固态硬盘驱动器(SSD)、以及其他闪存设备)；磁盘(例如内部硬盘或可移动盘)；磁光盘；以及光盘(例如CD和DVD盘)。处理器和存储器能够被补充有专用逻辑电路，或被并入专用逻辑电路中。
为了提供与用户的交互，本文中所描述的主体能够被实现在具有用于向用户显示信息的I/O设备(例如CRT、LCD、LED或投影设备)和输入或输出设备(例如键盘和指点设备，所述指点设备例如鼠标或轨迹球)的计算机上，用户能够通过所述输入或输出设备向计算机提供输入。其他种类的设备也能够被用于提供与用户的交互。例如，被提供给用户的反馈能够是任何形式的感官反馈(例如视觉反馈、听觉反馈或触觉反馈)，并且能够以任何形式(包括声学、语音或触觉输入)来接收来自用户的输入。
本文中所描述的主体能够被实现在计算系统中，所述计算系统包括后端部件(例如数据服务器)、中间件部件(例如应用服务器)或前端部件(例如具有图形用户界面或网页浏览器的客户端计算机360，用户能够通过所述图形用户界面或网页浏览器与本文中所描述的主体的实现方式进行交互)，或者这样的后端部件、中间件部件和前端部件的任意组合。系统的部件能够通过任何形式或介质的数字数据通信的网络409(例如通信网络)互连。通信网络的范例包括蜂窝网络(3G、4G)、局域网(LAN)、以及广域网(WAN)，例如互联网。
本文中所描述的主体能够被实现为一个或多个计算机程序产品，例如被有形地体现在信息载体中(例如非瞬态计算机可读介质中)用于由数据处理装置(例如可编程处理器、计算机或多个计算机)运行或控制数据处理装置的操作的一个或多个计算机程序。能够以任何形式的程序语言来编写计算机程序(又称程序、软件、软件应用、app、宏或代码)，所述编程语言包括编译语言或解析语言(例如C、C++、Perl)，并且其能够被以任何形式来部署，包括作为独立程序或作为模块、部件、子例程，或适合于在计算环境中使用的其他单元。本发明的系统和方法能够包括本领域已知的编程语言，包括但不限于C、C++、Perl、Java、ActiveX、HTML5、Visual Basic或JavaScript。
计算机程序不必与文件相对应。程序能够被存储在保存有其他程序或数据的文件的部分中、专用于所讨论的程序的单个文件中、或者多个协作文件(例如存储一个或多个模块、子程序或代码的部分的文件)中。计算机程序能够被部署为在一个计算机上运行、或者在位于一处或分布在多个位置上并通过通信网络互连的多个计算机上运行。
例如，文件能够是存储在硬盘驱动器、SSD、CD或其他有形的非瞬态介质上的数字文件。能够通过网络409将文件从一个设备发送到另一个设备(例如作为通过网络接口卡、调制解调器、无线网卡等被从服务器发送到客户端的包)。
例如，对根据本发明的文件进行写入涉及由读/写头通过添加、移除或重排(例如具有静电荷或偶极矩的)粒子而将有形的非瞬态计算机可读介质转变成磁化样式，所述样式接着表示用户期望且对用户有用的新的信息。在一些实施例中，写入涉及对具有特定属性的有形的非瞬态计算机可读介质中的材料的物理变换，使得光学读/写设备接着能够读取新的且有用的信息搭配(例如烧制CD-ROM)。在一些实施例中，写入文件包括使用闪存(例如NAND闪存)并将信息存储在包括浮栅晶体管的存储单元的阵列中。写入文件的方法在本领域中是周知的，并且例如能够由程序或者由来自软件的保存命令或来自编程语言的写入命令自动调用。
在特定的实施例中，显示器380被绘制在计算机操作系统(例如Windows、Mac OS或Linux)环境内，或者在专用系统的显示器或GUI内。显示器380能够包括与显示器相关联的任何标准控件(例如视窗环境内)，包括最小化和关闭按钮、滚动条、菜单、以及调整窗口大小的控件。能够由操作系统、视窗环境、应用程序编程接口(API)、网页浏览器、程序、或它们的组合来提供显示器380的元素(例如在一些实施例中，计算机包括操作系统，诸如网页浏览器的独立程序在所述操作系统中运行，并且该独立程序提供API中的一个或多个以绘制GUI的元素)。显示器380还能够包括与查看图像(例如缩放、颜色控件、亮度/对比度)或者处理文件有关的任何控件或信息，所述文件包括三维图像数据(例如打开、保存、关闭、选择、剪切、删除等)。另外，显示器380能够包括与操作三维图像捕捉系统(例如运行、停止、暂停、加电、掉电)有关的控件(例如按钮、滑块、标签、开关)。
在特定的实施例中，显示器380包括与可利用不同的成像模态操作的三维成像系统有关的控件。例如，显示器380可以包括开始、停止、缩放、保存等按钮，并且可以通过与功能流设备和外部成像模态交互操作的计算机程序来绘制。因此，显示器380能够显示从三维数据集导出的图像，而无论系统的成像模式如何。
通过引用的并入
本公开中参考并引用了其他文件，例如专利、专利申请、专利公开、期刊、图书、文章、网页内容。出于所有目的而在此通过引用将所有这样的文件整体并入本文。
等价方案
本领域技术人员根据该文件的全部内容，包括对其中引用的科学和专利文献的参考，将意识到除了在本文中示出并描述的那些以外的本发明的各种修改以及本发明的许多另外的实施例。
本文的主体包含能够适于本发明在其各种实施例以及其等价方案中的实践的重要信息、例证和引导。

Claims (18)

1.一种用于评估对象的脉管系统的系统，包括：
处理器；以及
计算机可读存储介质，其具有指令，所述指令在运行时令所述处理器：
经由与不透辐射标签共同定位的数据收集器来接收所述对象的功能流数据；
接收包括所述不透辐射标签的所述脉管系统的成像数据；
生成与所述功能流数据相对应的脉管系统图图像；
针对一个或多个参数分析所述功能流数据；并且
在所述脉管系统图图像上提供指示所述脉管系统中的所述一个或多个参数处于阈值水平或超过阈值水平处的位置或区域的警告。
2.如权利要求1所述的系统，其中，所述计算机可读存储介质具有指令，所述指令在运行时令所述处理器在所述生成的步骤之前：
对所述功能流数据与所述脉管系统的所述成像数据进行共同配准。
3.如权利要求1所述的系统，其中，所述计算机可读存储介质具有指令，所述指令在运行时令所述处理器：
在监视器上显示所述脉管系统图图像；并且
示出所述数据收集器在所述脉管系统图图像上的位置。
4.如权利要求3所述的系统，其中，所述计算机可读存储介质具有指令，所述指令在运行时令所述处理器：
提供包括在所述数据收集器的所述位置处的所述功能流数据的功能流图像。
5.如权利要求4所述的系统，其中，所述计算机可读存储介质具有指令，所述指令在运行时令所述处理器：
经由所述监视器显示包括所述脉管系统图图像和所述功能流图像的合成图像。
6.如权利要求1所述的系统，其中，所述警告是视觉警告。
7.如权利要求6所述的系统，其中，所述视觉警告是从包括以下的组中选择的：颜色编码的指示符、闪烁指示符、所述一个或多个参数的彩图、调出标志物、或它们的组合。
8.如权利要求3所述的系统，其中，所述数据收集器的所述位置是所述数据收集器的实时位置。
9.如权利要求1所述的系统，其中，所述功能流数据包括从包括以下的组中选择的数据：压力数据、流量数据、或它们的组合。
10.一种用于评估对象的脉管系统的方法，所述方法包括：
经由与不透辐射标签共同定位的数据收集器来接收所述对象的功能流数据；
接收包括所述不透辐射标签的所述脉管系统的成像数据；
生成与所述功能流数据相对应的脉管系统图图像；
针对一个或多个参数分析所述功能流数据；并且
在所述脉管系统图图像上提供指示所述脉管系统中的所述一个或多个参数处于阈值水平或超过阈值水平处的位置或区域的警告。
11.如权利要求10所述的方法，其中，所述脉管系统图图像示出所述数据收集器的位置。
12.如权利要求11所述的方法，所述方法还包括以下步骤：
提供包括在所述数据收集器的所述位置处的所述功能流数据的功能流图像。
13.如权利要求12所述的方法，所述方法还包括以下步骤：
经由监视器显示包括所述脉管系统图图像和所述功能流图像的合成图像。
14.如权利要求10所述的方法，其中，所述警告是视觉警告。
15.如权利要求14所述的方法，其中，所述视觉警告是从包括以下的组中选择的：颜色编码的指示符、闪烁指示符、所述一个或多个参数的彩图、调出标志物、或它们的组合。
16.如权利要求11所述的方法，其中，所述数据收集器的所述位置是所述数据收集器的实际实时位置或所述数据收集器的之前的位置。
17.如权利要求10所述的方法，其中，所述功能流数据包括从包括以下的组中选择的数据：压力数据、流量数据、或它们的组合。
18.如权利要求10所述的方法，其中，所述方法包括在所述生成的步骤之前的对所述功能流数据与所述成像数据进行共同配准的步骤。
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