CN100584410C - 自动体外除纤颤器中的cpr灵敏的ecg分析 - Google Patents
自动体外除纤颤器中的cpr灵敏的ecg分析 Download PDFInfo
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Abstract
一种自动体外除纤颤器，包括：传感器，用于检测救援人员向患者给予CPR胸部按压的时间；电极，用于施加到患者的胸部，以向患者给予除纤颤电击，并且用于检测ECG信号；除纤颤电路，用于向电极给予除纤颤电击；和处理器和相关的存储器，用于执行控制除纤颤器操作的软件。该软件提供：ECG分析，用于分析ECG信号，以确定心节律是否是可电击的；CPR检测，用于分析传感器的输出，以确定给予CPR胸部按压的时间，和ECG分析同CPR检测的集成，由此关于心节律是否是可电击的确定仅基于其中未给予CPR胸部按压的ECG信号的时间时段。
Description
技术领域
本发明涉及一种自动体外除纤颤器(AED)，并且特别地，涉及一种由该除纤颤器执行的信号处理。
背景
自动体外除纤颤器包括信号处理软件，其分析获得自受害者的ECG信号，以确定诸如心室纤颤(VF)或者可电击室性心动过速(VT)的节律失常何时存在。通常，这些算法被设计为，在救援事件的过程中的特定时间执行ECG分析。通常在将除纤颤电极附装于患者之后的数秒内启动第一ECG分析。基于第一分析的结果，可以启动或者可以不启动后继的ECG分析。典型地，如果第一分析检测到可电击节律，则建议救援人员给予除纤颤电击。在电击给予之后，自动启动第二分析，以确定除纤颤治疗是否成功(即，可电击ECG节律是否被转化为正常的或其他不可电击节律)。如果该第二分析检测到可电击节律失常的持续存在，则AED建议用户给予第二除纤颤治疗。然后可以启动第三ECG分析以确定第二电击是否有效。如果可电击节律继续存在，则建议救援人员给予第三除纤颤治疗。
在第三除纤颤器电击之后，或者在上文描述的任何分析检测到不可电击节律时，由美国心脏协会(American Heart Association)和欧洲复苏协会(European Resuscitation Council)推荐的治疗方案需要救援人员检查患者的脉搏，或者评估患者的循环体征。如果不存在脉搏或者循环体征，则救援人员被训练为对受害者执行CPR持续一分钟或数分钟的时段。在该心肺复苏时段(其包括人工呼吸和胸部按压)之后，AED重新启动一系列的多达3个的额外ECG分析，其间散布有如上文所描述的适当除纤颤治疗。只要AED电源开启并且患者连接到AED设备，则跟随有1～3分钟的CPR的3个ECG分析/除纤颤电击的顺序以重复的方式继续。典型地，AED提供音频提示，以通知救援人员分析将在何时开始、分析结果是什么、以及何时开始和停止给予CPR。
同许多AED相关联的一个限制是，每组ECG分析和电击之间的时段是预先编程到设备中的，并且对于所有的救援情况是固定的。当由于缺乏循环而准许应用CPR时，该预先编程的时段被给予人工呼吸和胸部按压所消耗。当由于在将患者转化为灌注心节律时上次电击是有效的而使得未准许CPR时，该预先编程的时段被周期性地监视患者脉搏以及确保不发生复发或者重新纤颤所消耗。在某些医院外的救援方案中，连续的ECG分析组之间的时段可以长达3分钟。
公知的是，已成功地被除纤颤的心博停止的受害者有时候在成功的电击治疗后不久复发心室纤颤，在该情况中，紧跟在除纤颤之后验证脉搏存在并且因此确定不执行CPR的救援人员，在约1～3分钟后执行下一ECG分析之前，可能不了解受害者的条件已恶化。在这些条件下，所需除纤颤治疗和CPR的给予可能延迟。
某些AED被设计为，每当除纤颤电极连接到患者时，通过连续地和自动地分析受害者的ECG，在治疗中避免该不需要的延迟。这些AED执行连续的“背景”分析，其评估在分析/电击顺序之间的1～3分钟的CPR/监视时段中受害者的ECG信号。同样地，它们能够检测受害者心脏的重新纤颤(如果其发生)并且立即告知救援人员患者的恶化状况。尽管这些“改进的”系统有助于防止可能由患者心脏的未检测到的重新纤颤产生的治疗中的延迟，但是它们也易于将由CPR相关的胸部按压所引入的ECG人为现象误解释为可电击节律失常。当ECG分析算法将CPR相关ECG人为现象误解释为可电击节律时，其可能建议救援人员过早地停止执行CPR并且给予除纤颤治疗。尽管在某些情况中，立即除纤颤可能是适当的治疗，但是一些临床研究显示，相比于立即除纤颤，除纤颤治疗顺序之间的适当长的CPR时段对于患者是更加有益的，特别是在VF具有长的持续时间或者持续复发时。而且，当受害者的心节律不能通过除纤颤疗法治疗(不可电击的)而是同生命不相容时，诸如心搏停止或电机械分离的情况中，响应于可电击心节律的错误检测的CPR的过早终止可能减少患者的存活机会。
对于那些在分析/电击顺序之间的时段中执行背景ECG分析的AED，用于确保即使在出现可电击节律的情况下为有效的CPR给予提供足够时间的常见策略是禁用背景ECG分析，或者在每个治疗顺序的上次电击之后的预定时间的时段内，忽略该分析的结果。在该时段中，在没有来自存在可电击节律的单元的建议的情况下，允许救援人员执行CPR。在该时段之后，使用ECG分析的结果提示用户停止CPR，并且因此允许执行无CPR人为现象的ECG分析。
由于多数当前可利用的AED未配备用于检测或监视CPR相关的胸部按压的给予，因此它们不能够确定ECG信号中何时出现CPR人为现象以及何时其不出现。因此，它们的背景ECG分析功能的自动起动/停用唯一地基于距离上次电击或上次“前景”ECG分析完成的时间。如果CPR的给予在背景ECG被分析禁用的这个时段期间停止，则患者ECG节律中的危及生命的变化在救援事件过程中的至少某些时间时段中仍为未被检测的(即使它能够被有效地分析)。
发明内容
总的来说，本发明的特征在于一种自动体外除纤颤器，包括：传感器，用于检测救援人员向患者给予CPR胸部按压的时间；电极，用于施加到患者的胸部，以向患者给予除纤颤电击，并且用于检测ECG信号；和除纤颤电路，用于向电极给予除纤颤电击。执行ECG分析以确定心节律是否是可电击的(即，是否可通过除纤颤疗法治疗)。检测传感器的输出，以确定给予了CPR胸部按压的时间。ECG分析和CPR检测被集成，由此关于心节律是否可通过除纤颤疗法治疗的确定仅基于其中未给予CPR胸部按压的ECG信号的时间时段。
本发明改善了ECG节律分类的特异性以及可靠性。(例如，在ECG背景分析过程中的)ECG节律分类的改善的可靠性以至少两种方式增加了受害者的存活机会。当受害心者的节律实际上不能通过除纤颤疗法治疗时(例如，诸如心搏停止或电机械分离的情况，其较为适用的疗法是CPR)，其减少了由于可电击心节律的错误检测而导致的所需CPR的过早终止的可能性。其通过允许在分析/电击顺序之间的1～3分钟的CPR监视时段期间连续地和自动地分析受害者的ECG，避免了重新纤颤发生时对该重新纤颤治疗中的不需要的延迟。
本发明的优选实现方案可以并入一个或者多个下列特征：
ECG分析可以包括在最小ECG分析时间期间的ECG信号分析，以确定心节律是否是可电击的，并且其中可以完成ECG分析和CPR检测的集成，由此仅在以下情况下做出心节律是可电击的确定，即其中如果分析ECG信号以做出该确定的时间时段包括至少同其中未给予CPR胸部按压的最小ECG分析时间一样长的时间时段。
当CPR胸部按压已给予时，可以重置定时器，并且可以检查定时器的值以确定是否已经超过最小ECG分析时间。
当确定CPR胸部按压已给予时，可以重新启动ECG分析，并且仅在ECG分析未被重置的情况下执行了至少最小ECG分析时间之后，做出关于心节律是否是可电击的确定。
在其中做出关于心节律是否是可电击的确定的时段中，可以连续地执行ECG分析和CPR检测。
本发明的其他特征和优点将通过下面的附图和详细描述，并通过权利要求，将变得显而易见。
附图说明
图1是本发明的一个实现方案的框图。
图2是图1的实现方案的集成任务的框图。
图3是本发明的另一实现方案的框图。
图4是图3的实现方案的ECG分析的框图。
图5是本发明的另一实现方案的框图。
图6是图5的实现方案的集成任务的框图。
具体实施方式
存在很多可行的本发明的不同实现方案，太多以至于不可能在这里尽述。下文描述了目前优选的某些可行的实现方案。然而，不能过于强调的是，这些是本发明实现方案的描述而不是本发明的描述，其不限于该章节中描述的详细实现方案，而是在权利要求中的更广泛的方面中描述的。
图1示出了一个优选实现方案，其中CPR检测任务20和ECG背景分析任务22在1至3分钟的CPR预先编程的间隔中同时且连续地进行。CPR检测任务的输出(例如，给予CPR按压的时间、按压的幅度、按压的速率)和ECG分析任务的输出(例如，检测到QRS的时间、心率和节律分类)传递到高级集成任务24。该高级集成任务分析来自ECG和CPR任务的数据，并且基于ECG分析时段中的CPR胸部按压检测的存在或不存在，限定ECG节律分类。例如，如果检测到CPR胸部按压，则该高级集成任务在按压之后的至少X秒的时间间隔内忽略背景ECG节律分类，其中X秒是ECG背景分析算法需要的用于对ECG节律分类的最小时间间隔。这确保了在至少X秒的持续时间内，ECG背景分析算法使用无噪声的ECG信号进行其分类。结果，由于ECG信号中的CPR相关人为现象导致的错误可电击节律检测的数目减小，并且改善了ECG节律分类的特异性以及可靠性。ECG背景分析的该改善的可靠性按照以下两种方式增加了受害者的存活机会：(1)当受害者的心节律实际上不能通过除纤颤疗法治疗时(例如，诸如心搏停止或电机械分离的情况，其较为适用的疗法是CPR)，其消除了由于可电击心节律的错误检测而导致的所需CPR的过早终止；(2)其通过在分析/电击顺序之间的1～3分钟的CPR监视时段中连续地和自动地分析受害者的ECG，并且通知救援人员检测到可电击节律的时间，避免了重新纤颤发生时对该重新纤颤治疗中的不需要的延迟。
图2示出了集成任务遵循的处理。接收来自CPR任务的CPR按压检测数据和来自ECG任务的ECG节律分类数据。该集成任务检查是否检测到按压(30)。如果检测到CPR按压，则该集成任务将自从检测到上次按压起消逝的时间T0设置为0(32)，并且继续执行并检查新的按压检测。如果未检测到新的按压，则该集成任务计算自从检测到上次按压起消逝的时间T0(34)。然后其检查以确定T0是否大于ECG分析算法需要的用于生成节律分类的时间(X秒)(36)。如果T0小于X秒，则该集成任务返回，以检查新检测的CPR按压。如果T0大于X秒，则该集成任务移动到检查(38)自ECG任务接收到节律分类。如果报告了可电击节律，则该集成任务警告用户可电击节律的存在(40)，并且使除纤颤器切换至ECG前景分析状态(42)。
图3示出了另一实现方案。CPR检测任务50和ECG背景分析任务52在CPR预先编程的间隔中同时且连续地进行。CPR任务的输出传递到ECG任务，并且ECG任务使用CPR数据，以基于ECG分析时段期间的CPR胸部按压检测的存在或不存在，限定ECG节律分类。例如，如果检测到CPR胸部按压，则ECG任务将重新开始其ECG节律分类处理，其通常需要X秒的预先定义的时间间隔以完成其节律分类。该方法确保了在所需用于分类节律的预先定义的时间间隔X秒内，ECG背景分析算法使用无噪声ECG信号进行其分类。结果，减少了错误可电击节律检测的数目。因此，改善了ECG节律分类的特异性和可靠性。
图4示出了图3的实现方案中的ECG背景分析任务遵循的处理。ECG任务同时且连续地接收来自CPR任务的CPR按压检测数据和来自除纤颤器前端的ECG波形数据。在接收到ECG波形数据样本时，ECG任务检查是否检测到按压(62)。如果检测到CPR按压，则ECG任务通过使其从时间0重新开始，重新启动ECG分析(64)。ECG分析任务分析长度为X秒的ECG数据分段，以确定ECG节律。通过启动ECG分析处理，ECG任务重新开始其长度为X秒的新的ECG数据分段的分析，而未导致下一X秒的ECG节律分类。如果未检测到新的按压，则ECG任务检查是否已启动了分析处理(60)。如果没有ECG分析正在进行，则ECG任务启动ECG分析处理(64)。如果已启动了ECG分析，则ECG任务继续分析ECG波形数据持续X秒的持续时间。如果未检测到可电击节律(66)，则ECG任务返回，以接收下一样本。如果报告了可电击节律(66)，则ECG任务切换到ECG前景分析状态(68)，并且警告用户可电击节律的存在(70)。
图5示出了另一实现方案。CPR检测任务70和ECG背景分析任务72在1至3分钟的CPR预先编程的间隔中同时且持续地进行。CPR任务的输出和ECG任务的输出传递到高级集成任务74。该高级集成任务分析来自ECG和CPR任务的数据，并且在检测到CPR胸部按压时重新启动ECG节律分类。当由ECG任务报告可电击节律时，该高级集成任务将其警告给用户。例如，如果检测到CPR胸部按压，则该高级集成任务将重新开始ECG节律分类处理，其通常需要X秒的预先定义的时间间隔以完成其节律分类。该方法确保了在所需用于对节律分类的预先定义时间间隔X秒内，ECG背景分析算法使用无噪声的ECG信号进行其分类。
图6示出了图5的实现方案中的集成任务遵循的处理。该集成任务接收来自CPR任务的CPR按压检测数据和来自ECG任务的ECG节律分类数据。该集成任务检查是否已检测到按压(80)。如果检测到CPR按压，则该集成任务通过使其从时间0重新开始来重新启动ECG分析(82)。ECG分析任务分析长度为X秒的ECG数据分段，以确定ECG节律。通过启动ECG分析处理，ECG任务重新开始其长度为X秒的新的ECG数据分段的分析，而未导致下一X秒的ECG节律分类。如果未检测到新的按压，则该集成任务检查接收自ECG任务的节律分类(84)。如果报告了可电击节律，则该集成任务警告用户可电击节律的存在(86)，此时除纤颤器切换到ECG前景分析状态。
除了上文描述以外的本发明的许多其他实现方案涵盖于由权利要求限定的本发明内。
Claims (8)
1.一种用于向患者给予除纤颤电击的自动体外除纤颤器，包括：
传感器，用于检测救援人员向患者给予CPR胸部按压的时间；
电极，用于施加到患者的胸部，以向患者给予除纤颤电击，并且用于检测ECG信号；
除纤颤电路，用于向电极给予除纤颤电击；
用于执行控制除纤颤器操作的处理器和相关的存储器，包括：
ECG分析装置，用于分析ECG信号，以确定心节律是否是可电击的；
CPR检测装置，用于分析传感器的输出，以确定给予CPR胸部按压的时间，和
集成装置，用于集成ECG分析和CPR检测的，由此关于心节律是否是可电击的确定仅基于其中未给予CPR胸部按压的ECG信号的时间时段，
其中，ECG分析包括最小ECG分析时间期间的ECG信号分析，以确定心节律是否是可电击的，并且其中完成ECG分析和CPR检测的集成，由此仅在以下情况下做出心节律是可电击的确定，即其中如果分析ECG信号以做出该确定的时间时段包括至少同其中未给予CPR胸部按压的最小ECG分析时间一样长的时间时段。
2.权利要求1的除纤颤器，其中当CPR胸部按压已给予时，重置定时器，并且由软件检查定时器的值以确定是否已经超过最小ECG分析时间。
3.权利要求2的除纤颤器，其中当该软件确定CPR胸部按压已给予时，重新启动ECG分析，并且仅在ECG分析未被重置的情况下执行了至少最小ECG分析时间之后，做出关于心节律是否是可电击的确定。
4.权利要求3的除纤颤器，其中在其中做出关于心节律是否是可电击的确定的时段中连续地执行ECG分析和CPR检测。
5.一种用于向患者给予除纤颤电击的自动体外除纤颤器，包括：
传感器，用于检测救援人员向患者给予CPR胸部按压的时间；
电极，用于施加到患者的胸部，以向患者给予除纤颤电击，并且用于检测ECG信号；
除纤颤电路，用于向电极给予除纤颤电击；
ECG分析装置，用于分析ECG信号，以确定心节律是否是可电击的；
CPR检测装置，用于分析传感器的输出，以确定给予CPR胸部按压的时间，和
集成装置，用于集成ECG分析和CPR检测，由此关于心节律是否是可电击的确定仅基于其中未给予CPR胸部按压的ECG信号的时间时段，
其中，ECG分析包括最小ECG分析时间期间的ECG信号分析，以确定心节律是否是可电击的，并且其中完成ECG分析和CPR检测的集成，由此仅在以下情况下做出心节律是可电击的确定，即其中如果分析ECG信号以做出该确定的时间时段包括至少同其中未给予CPR胸部按压的最小ECG分析时间一样长的时间时段。
6.权利要求5的除纤颤器，其中当CPR胸部按压已给予时，重置定时器，并且检查定时器的值以确定是否已经超过最小ECG分析时间。
7.权利要求6的除纤颤器，其中当确定CPR胸部按压已给予时，重新启动ECG分析，并且仅在ECG分析未被重置的情况下执行了至少最小ECG分析时间之后，做出关于心节律是否是可电击的确定。
8.权利要求7的除纤颤器，其中在其中做出关于心节律是否是可电击的确定的时段中连续地执行ECG分析和CPR检测。
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-
2003
- 2003-02-19 US US10/370,036 patent/US6961612B2/en not_active Expired - Lifetime
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2004
- 2004-02-12 EP EP04710657A patent/EP1603637B1/en not_active Expired - Lifetime
- 2004-02-12 CN CN200480004617A patent/CN100584410C/zh not_active Expired - Fee Related
- 2004-02-12 JP JP2006503520A patent/JP4531746B2/ja not_active Expired - Lifetime
- 2004-02-12 WO PCT/US2004/004115 patent/WO2004073493A2/en active Application Filing
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2005
- 2005-11-01 US US11/264,819 patent/US8160698B2/en active Active
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2012
- 2012-04-13 US US13/447,113 patent/US20120245648A1/en not_active Abandoned
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|---|---|
| US6961612B2 (en) | 2005-11-01 |
| US8160698B2 (en) | 2012-04-17 |
| EP1603637A2 (en) | 2005-12-14 |
| WO2004073493A3 (en) | 2005-04-21 |
| US20120245648A1 (en) | 2012-09-27 |
| WO2004073493A8 (en) | 2005-09-29 |
| US20040162585A1 (en) | 2004-08-19 |
| JP4531746B2 (ja) | 2010-08-25 |
| CN1750857A (zh) | 2006-03-22 |
| EP1603637A4 (en) | 2006-06-14 |
| WO2004073493A2 (en) | 2004-09-02 |
| US20060122648A1 (en) | 2006-06-08 |
| EP1603637B1 (en) | 2011-05-25 |
| JP2006518637A (ja) | 2006-08-17 |
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