CN107820411B - 具有活动和非活动驱动器系统的导管漏洞环反馈故障检测 - Google Patents

具有活动和非活动驱动器系统的导管漏洞环反馈故障检测 Download PDF

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CN107820411B
CN107820411B CN201680035692.0A CN201680035692A CN107820411B CN 107820411 B CN107820411 B CN 107820411B CN 201680035692 A CN201680035692 A CN 201680035692A CN 107820411 B CN107820411 B CN 107820411B
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S·A·哈雷兰德
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Abstract

避免了诸如系统内的流体进入之类的故障状态的假肯定检测的用于冷冻手术系统的一种故障检测方法、系统和设备。故障检测机构一般可包括：具有活动模式和非活动模式的驱动器，该驱动器在驱动器处于活动模式时产生输出信号；检测器，该检测器能接收驱动器输出信号；以及与驱动器和检测器通信的检测器验证控制器，该检测器验证控制器在检测器接收驱动器输出信号时将驱动器从活动模式改变为非活动模式。如果控制器确定在检测器所接收信号与驱动器输出信号之间存在相关性，那么控制器可确定真故障状态。如果控制器确定各信号不相关，那么所有其他可能故障状态可被忽略。

Description

具有活动和非活动驱动器系统的导管漏洞环反馈故障检测
技术领域
本发明涉及避免了诸如系统内的流体进入之类的故障状态的假肯定检测的用于冷冻手术系统的故障检测方法、系统和设备。
背景
低温处理可被用于处理各种状况，诸如心房纤颤、肿瘤治疗等等。一般，低温处理包括通过一个或多个流体递送管道从制冷剂源到低温处理设备内循环制冷剂，其中制冷剂膨胀并且将低温处理设备的一部分冷却至治疗温度。低温处理设备可与真空源流体连通，该真空源有助于从低温处理设备通过一个或多个流体回收管道将膨胀的制冷剂移除。
低温处理设备可能会出现泄漏，这不仅影响冷却效果还会威胁病人健康。
许多设备包括流体路径内某位置处的泄漏检测机构，该泄漏检测机构可被用于检测故障(例如，设备内的流体泄漏或血液进入)并警告用户。在一些情形中，流体递送被停止和/或真空源被停止活动以便帮助改善该状况。然而，泄漏检测机构可能将假肯定故障状态传达给用户。在这种情形中，由系统关闭导致的程序延误不仅延长了医疗程序的所需时间，而且频繁的系统关闭可导致系统上过多的机械或电耗损。
当前所知的故障检测机构包括沿电路径发送信号的驱动器，在电路径中，检测器被置于常开电路的另一端。如果血液或流体进入系统，那么故障检测机构会识别到故障状态。然而，诸如对检测线的电磁干扰之类的外部源可导致故障状态的错误检测。这种干扰在使用用于电生理程序的包括泄漏检测机构的医疗设备时，尤其在使用某一映射或消融设备(例如，Carto-3映射系统)的情况中，会频繁遇到。虽然一些变通方法是可用的，但是这些方法不够方便并且许多不被大众尤其是缺少经验的用户所熟知。
因此期望提供一种避免假肯定故障检测的用于冷冻手术系统的故障检测方法、系统和设备。
发明内容
本发明有利地提供一种避免诸如系统内的流体进入之类的故障状态的假肯定检测的用于冷冻手术系统的故障检测方法、系统和设备。故障检测机构一般可包括：具有活动模式和非活动模式的驱动器，该驱动器在驱动器处于活动模式时产生输出信号；检测器，该检测器能接收驱动器输出信号；以及与驱动器和检测器通信的检测器验证控制器，该检测器验证控制器在检测器接收驱动器输出信号时将驱动器从活动模式改变为非活动模式。驱动器和检测器可定义具有断开状态和闭合状态的电路，并且检测器可在电路处于闭合状态时接收驱动器输出信号。例如，电路可在流体将驱动器输出信号分流至检测器时处于闭合状态。检测器对驱动器输出信号的接收可指示可能故障状态。检测器验证控制器可被编程以便确定驱动器输出信号与检测器所接收信号之间的相关性值。例如，检测器验证控制器在相关性值高于预定阈值时可判定可能故障状态是真故障状态而在相关性值低于预定阈值时可判定可能故障状态是假肯定故障状态。作为非限制性示例，预定阈值可以是80％。此外，故障检测机构可仅在检测器验证控制器判定可能故障状态是真故障状态时产生警告而在检测器验证控制器判定可能故障状态是假肯定故障状态时不产生警告。
用于流体进入检测的系统一般可包括具有闭合状态和断开状态的电路，该电路包括：具有活动模式和非活动模式的驱动器，该驱动器在驱动器处于活动模式时产生输出信号；能在电路处于闭合状态时接收驱动器输出信号的检测器；以及与驱动器和检测器通信的检测器验证控制器，该检测器验证控制器在检测器接收驱动器输入信号时将驱动器从活动模式改变为非活动模式。检测器对驱动器输出信号的接收可指示可能的流体进入状态。检测器验证控制器可被编程以便确定驱动器输出信号与检测器所接收信号之间的相关性值。例如，检测器验证控制器可在相关性值高于预定阈值时判定流体进入存在而在相关性值低于预定阈值时可判定流体进入不存在。
医疗系统内识别故障的方法可包括由活动驱动器在电路中产生输出信号，由检测器接收输出信号，使驱动器停止活动，随后确定来自驱动器的输出信号与检测器所接收信号之间的相关性值。故障状态可在相关性值等于或大于预定阈值时被指示而非故障状态可在相关性值小于预定阈值时被指示。作为非限制性示例，预定阈值为80％。
附图说明
通过在结合所附附图考虑时参考以下详细描述，本发明更完整的理解以及其中伴随的优点和特征将更易被理解。
图1A示出现有技术中已知的故障检测机构的示意图，该故障检测机构识别真否定故障状态；
图1B示出现有技术中已知的故障检测机构的示意图，该故障检测机构识别真肯定故障状态；
图1C示出现有技术中已知的故障检测机构的示意图，该故障检测机构识别假肯定故障状态；
图2示出根据本申请的包括控制台、医疗设备和故障检测机构的系统的示意图；
图3A示出根据本申请的故障检测机构的示意图，该故障检测机构包括检测器验证控制器。
图3B示出图3A的故障检测机构的驱动器输出信号与检测器所接收信号之间的相互关系的图示；
图4A示出在存在噪声源时根据本申请的故障检测机构的示意图，该故障检测机构包括检测器验证控制器；
图4B示出图4A的故障检测机构的驱动器输出信号与检测器所接收信号之间的相互关系的图示；
图5A示出多周期验证方法中驱动器输出信号的图示以及由本申请的故障检测机构管理的多周期验证方法中驱动器输出信号的图示，该故障检测机构识别假真故障状态；以及
图5B示出多周期验证方法中驱动器输出信号的图示以及由本申请的故障检测机构管理的多周期验证方法中驱动器输出信号的图示，该故障检测机构避免存在噪声源时对假肯定状态的识别。
具体实施方式
现参考图1A-1C，现有技术中已知的故障检测机构被示出。在当前已知的故障检测机构10(诸如用于流体路径或医疗设备内的血液检测的那些机构)中，驱动器12被用于沿电路径发送信号，在电路径中，检测器14被置于常开电路的另一端处以便监测系统中血液或流体进入的存在。然而，这些设计中流体的错误检测(即，故障状态的假肯定指示)有时会被诸如检测线的电磁干扰之类的外部源触发，这会导致故障检测机构识别到故障状态。
在图1A-1C中所示出的公知的故障检测机构10中，驱动器12和检测器14一起定义了并行电路。驱动器12可具有活动模式和非活动模式，并且可在处于活动模式时产生输出信号16(例如，AC或DC)。检测器14检测或监测指示系统中诸如血液或流体进入之类的故障状态的活动驱动器12输出信号的存在。例如，流体可充当用于闭合常开的驱动器-检测器电路的分流器。在没有流体进入的情形中(如图1A中所示)，检测器14检测不到活动驱动器12输出信号，或检测不到处于等于或大于触发电压的电压的活动驱动器12信号，因此检测器14不指示故障状态。即，检测器14在检测器输入<V触发时不指示故障状态。
在流体已进入系统的情形中(如图1B中所示)，常开电路被流体分流并闭合该电路，检测器14将检测到活动驱动器12输出信号并且指示故障状态。即，检测器14在检测器输入>V触发时指示故障状态。
在诸如电磁干扰之类的噪声源18存在于电路径上的情形中，故障检测机构10可能将噪声与活动驱动器12输出信号混淆并且指示假肯定故障状态(如图1C中所示)。即，检测器14在检测器输入>V触发时指示假肯定故障状态。此类情形会需要用户介入、系统重启或转换到故障处理模式，以上所有选项在系统应当正常操作时都是不被期望的。
现参考图2-5B，包括检测器验证控制器22的故障检测机构20被示出，并且图2示出包括低温处理设备32、控制台34以及一个或多个故障检测机构20的的医疗系统30的示意图。低温处理设备32可以是流体(诸如用于组织低温处理的制冷剂)通过它循环的任何设备。作为非限制性示例，低温处理设备32可包括近端部分38和远端部分40，在远端部分40处或内部具有膨胀室42。例如，低温处理设备32可包括定义了膨胀室42的诸如气球之类的可膨胀元件(未示出)。此外或替代地，低温处理设备32可包括定义了膨胀室42的不可膨胀的远端部分40，诸如如果低温处理设备是冷冻探针或焦导管(focal catheter)，那么可能就是这种情形。低温处理设备32还可包括一个或多个其他能量递送元件，诸如与能量源(例如，射频能量)、激光二极管或类似项(未示出)通信的电极。
低温处理设备32可与控制台34通信，控制台34一般可包括制冷剂源44、一个或多个计算机46和/或一个或多个能量源48。系统30还可包括低温处理设备和控制台中的一个或多个流体管道。例如，流体递送50管道可以与制冷剂源44和低温处理设备32流体连通，并且可从制冷剂源44将制冷剂递送到低温处理设备32的膨胀室42。此外，流体回收管道52可与膨胀室42和真空源54流体连通以便从低温处理设备32收回膨胀的制冷剂。
一个或多个计算机46可被编程以便执行一个或多个算法，该算法用于来自于一个或多个故障检测机构20的信号的接收、处理和/或解释。如以下所更详细讨论的，每个故障检测机构20的至少一部分可在一个或多个计算机46内或者是一个或多个计算机46的组件并且能解释和传达故障状态判定。故障检测机构信号解释的结果可通过一个或多个显示器、音频设备、发光显示器、警报器或其他装置被控制台34传达给用户。至少部分地基于所传达的故障状态，用户可手动调整系统设置和/或系统可自动或半自动地调整系统设置。作为非限制性示例，被故障检测机构识别并被系统传达的故障状态可提示用户停止真空源的活动和/或到低温处理设备32的制冷剂的递送。替代地，系统可自动或半自动地执行相同任务。
现参考图3A-5B，故障检测机构20被更详细地示出。故障检测机构可包括驱动器56和检测器58。不像公知的故障检测机构10(如图1A-1C中所示)，图3A-5B中的故障检测机构20还可包括主动控制驱动器56(如图3A中所示)的检测器验证控制器22。一个或多个故障检测机构20可位于低温处理设备32、一个或多个流体管道和/或控制台34中。作为非限制性示例，即使故障检测机构可检测低温处理设备32内的故障(诸如泄漏或血液进入)，但故障检测机构20可位于控制台34内。此外，至少检测器验证控制器22可以在控制台34的一个或多个计算机46内或者是控制台34的一个或多个计算机46的组件。然而，将会理解，故障检测机构20或其组件可位于系统30中的任何地方，系统30允许对诸如流体进入之类的系统故障的检测。
与图1A-1C中所示出和描述的故障检测机构10类似，驱动器56和检测器58可一起定义具有断开状态(诸如在不存在故障时)和闭合状态(诸如在存在流体进入时)的并联电路。驱动器56可具有活动模式和非活动模式，并且可在处于活动模式时产生输出信号62(例如，AC或DC)。检测器58可检测或监测活动驱动器输出信号62的存在，活动驱动器输出信号62可指示系统30中的故障状态，诸如血液或流体进入。例如，流体可充当用于闭合常开的驱动器-检测器电路的分流器。
检测器验证控制器22可以是基于硬件的或基于软件的。例如，检测器验证控制器22可被实现为系统30的硬件中的专门电路，或者它可用一个可配置算法(诸如一个实现于系统软件中的算法)来处理。
如果检测器58识别出故障状态，则检测器验证控制器22可将驱动器56的状态从“活动”变为“非活动”，并且随后可继续监测检测器58一段时间。如果检测器58的状态响应于驱动器56的状态改变，则低温处理设备32中血液或流体的存在是更有可能的。另一方面，如果检测器58不响应驱动器56的状态改变，那么可能所识别的故障状态是由于系统30中的错误信号66(诸如电磁噪声或其他噪声源)导致的。在这种情形中，检测器验证控制器22可阻止系统30将假肯定传达给用户和/或可阻止故障检测机构20将假肯定传达给系统30。
如图3B的比较中以图形方式示出的，检测器验证控制器22可响应于来自检测器58的潜在故障信号的检测。虽然检测器58处于非故障状态(即，电路是断开的并且没有故障状态被指示)，但驱动器/检测器电路可保持活动以便检测将指示故障状态的系统30中的任何流体。这段时间可被称为“初始采样间隔”。如果检测器58基于驱动器56信号(例如，检测器输入>V触发)识别到潜在故障状态，则检测器验证控制器22可接着将驱动器56的状态从“活动”变成“非活动”(或从“高”变成“低”，或从“打开”变成“关闭”)。检测器验证控制器22可继续监测检测器58一段时间，这可被称为“后续采样间隔”。检测器验证控制器22可在驱动器56处于活动模式和非活动模式时确定或计算出驱动器输出信号62与检测器64所接收/检测到的信号之间的相关性。如果检测器58的状态响应于驱动器56的状态改变(例如，如图3B中所示)，则低温处理设备中血液或流体的存在是更有可能的。即，如果以下两者都为真，那么可指示真故障状态：
(当输出(驱动器)＝活动时，输入(检测器)≥V触发)(1)
(当输出(驱动器)＝非活动时，输入(检测器)≤V触发)(2)
用户可根据，例如，个人病历、系统设计或其他要素来设置触发电压(V触发)。作为非限制性示例，V触发可被设置在大约30mV(±10mV)。然而，将会理解，也可使用其他触发电压。此外，触发电压可在驱动器56的状态是“活动”的时被设置成比在驱动器56的状态是“非活动”的时更高的电压。即，V触发-活动的可比V触发-非活动的大。
作为非限制性示例，真故障状态指示所需的百分比相关性可以是至少80％。缺乏相关性(即，驱动器与检测器的相关性是0或大致为0，或小于预定阈值，诸如80％的相关性)可被用作来自检测器58的真肯定与假肯定识别之间的鉴别器。如图3B中所示，在驱动器56处于非活动模式时驱动器56输出信号62中的减小可在输出驱动器信号62和检测器58所接收信号64是相关的时引起检测器58所接收信号64的相应减小。
如图4A和4B中所示，如果检测器58在后续采样间隔期间不响应于驱动器56的状态改变，则更有可能的是检测器58因环境电磁干扰或其他非物理原因而出错(corrupted)。如以上所讨论的，虽然检测器58处于非故障状态，驱动器/检测器电路可在初始采样间隔期间保持活动以便检测将指示故障状态的系统30内的任何流体。如果检测器58基于驱动器信号62(例如，检测器输入>V触发)识别到潜在故障状态，则检测器验证控制器22可接着将驱动器56的状态从“活动”变成“非活动”(或从“高”变成“低”，或从“打开”变成“关闭”)。检测器验证控制器22可在后续采样间隔期间继续监测检测器58。如果检测器58的状态不响应于驱动器56的状态改变(例如，如图4B中所示)，则对于检测器的噪声或干扰的存在是更有可能的。即，如果以下两者都为真，那么假肯定故障状态可被避免(即，真故障状态不存在)：
(当输出(驱动器)＝活动时，输入(检测器)≥V触发)(3)
(当输出(驱动器)＝非活动时，输入(检测器)≥V触发)(4)
如图4B中所示，在驱动器56处于非活动模式时驱动器56输出信号62中的减小可在输出驱动器信号和检测器58所接收信号是不相关的时不引起检测器58所接收信号64的相应减小。
如图5A和5B中所示，检测器验证控制器22将驱动器56的状态改变一次或多次并且继续监测检测器以便作出实际故障状态的最终判定，并且检测器验证控制器22可进一步被编程以便计算或确定驱动器输出信号62状态与检测器58所检测到或接收到的信号64之间的相关性。即，故障检测方案可被设计成在多个采样间隔期间的n个周期中将驱动器状态改变多次以便在识别故障状态之前确保给检测器的输入是一致的(即，驱动器与检测器的相关性是1或大致为1)。在短暂的噪声干扰故障检测机构的情形中，这会是有益的。作为非限制性示例，真故障状态指示所需的百分比相关性可以是至少80％。缺乏相关性(即，驱动器与检测器的相关性是0或大致为0，或小于预定阈值，诸如80％的相关性)可被用作来自检测器的真肯定与假肯定识别之间的鉴别器。例如，在图5A中所示出的多周期驱动器输出方案中，1或大致为1的相关性(图5B中所示)可指示真故障状态。相反地，0或大致为0的相关性可指示应该被故障检测机构忽略的由另一个机构(诸如电磁干扰或噪声)导致的假故障状态。
不同驱动器输出，诸如各种频率或占空比的AC信号，还可被用于判定是否检测器正响应于驱动器或者正响应于影响系统的其他信号。作为非限制性示例，驱动器输出信号62可以是以下各项中的至少一种：正弦波、方波、正弦脉冲或任何其他输出信号波形，只要检测器58可以在对应于活动信号(即，由处于“活动”状态的驱动器56产生的信号)的所接收信号与对应于非活动信号(即，由处于“非活动”状态的驱动器56产生的信号)的所接收信号之间进行区分。
本领域技术人员将会理解，本发明不限于以上所已经具体示出和描述的内容。此外，除非上文有相反提及，否则，应当注意所有附图不是按比例的。根据以上教导而不背离仅被所附权利要求限定的本发明的范围和精神，各种修改和改变是可能的。

Claims (12)

1.一种故障检测机构，包括：
具有活动模式和非活动模式的驱动器，所述驱动器被配置为用于在所述驱动器处于活动模式时产生输出信号；
检测器，所述检测器被配置为用于接收所述驱动器输出信号，其中，所述驱动器和所述检测器定义了常开电路，所述电路在流体将所述驱动器输出信号分流至所述检测器时处于闭合状态；以及
与所述驱动器和所述检测器通信的检测器验证控制器，所述检测器验证控制器在所述检测器接收到所述驱动器输出信号时将所述驱动器从所述活动模式变为所述非活动模式。
2.如权利要求1所述的故障检测机构，其中所述检测器在所述电路处于所述闭合状态时接收所述驱动器输出信号。
3.如权利要求1所述的故障检测机构，其中所述检测器验证控制器被编程以便确定所述驱动器输出信号与所述检测器所接收信号之间的相关性值。
4.如权利要求3所述的故障检测机构，其中所述检测器对所述驱动器输出信号的接收指示可能故障状态，并且所述检测器验证控制器在所述相关性值高于预定阈值时判定所述可能故障状态是真故障状态。
5.如权利要求4所述的故障检测机构，其中所述预定阈值是80％。
6.如权利要求3或权利要求4所述的故障检测机构，其中所述检测器对所述驱动器输出信号的接收指示可能故障状态，并且所述故障检测机构在所述检测器验证控制器判定所述可能故障状态是真故障状态时生成警告。
7.如权利要求3所述的故障检测机构，其中所述检测器对所述驱动器输出信号的接收指示可能故障状态，所述检测器验证控制器在所述相关性值低于预定阈值时判定所述可能故障状态是假肯定故障状态。
8.如权利要求7所述的故障检测机构，其中所述预定阈值是80％。
9.如权利要求6所述的故障检测机构，其中所述故障检测机构在所述检测器验证控制器判定所述可能故障状态是假肯定故障状态时不生成警告。
10.如权利要求1-2中任一项所述的故障检测机构，其中所述检测器对所述驱动器输出信号的接收指示可能的流体进入状态，并且其中所述检测器验证控制器被编程以便确定所述驱动器输出信号与所述检测器所接收信号之间的相关性值。
11.如权利要求10所述的故障检测机构，其中所述检测器验证控制器在所述相关性值高于预定阈值时判定所述流体进入存在。
12.如权利要求10所述的故障检测机构，其中所述检测器验证控制器在所述相关性值低于预定阈值时判定所述流体进入不存在。
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