CN1720074A - 用于在镇静和止痛系统中提供趋势分析的系统和方法 - Google Patents

用于在镇静和止痛系统中提供趋势分析的系统和方法 Download PDF

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CN1720074A
CN1720074A CNA2003801050366A CN200380105036A CN1720074A CN 1720074 A CN1720074 A CN 1720074A CN A2003801050366 A CNA2003801050366 A CN A2003801050366A CN 200380105036 A CN200380105036 A CN 200380105036A CN 1720074 A CN1720074 A CN 1720074A
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兰德尔·S·希克
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SCOTT LAB Inc
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Abstract

本发明包括能够以一种方式从与单个病人参数相关的单个监视器收集数据的镇静和止痛系统，所述方式减小了由于伪数据而导致的假正性警报响应的可能性。本发明也包括能够检测即将来临的异常病人状况的监视系统，其中所述状况可以在异常病人状况实际发生之前被检测到。本发明进一步包括用于将趋势分析结合到镇静和止痛系统中的方法。

Description

用于在镇静和止痛系统中提供趋势分析的系统和方法
                 相关申请的相互参照
本申请根据35U.S.C§119(e)要求申请日为2002年10月3日、名称为“用于在镇静和止痛系统中提供趋势分析的系统和方法”的美国临时专利申请No.60/415,524的优先权，将上述专利申请结合于此，作为参考。
            关于政府资助研究或开发的声明
不适用
                “微缩胶片附件”资料
不适用
                     本发明的背景
发明领域
本发明一般涉及趋势分析，以及尤其涉及结合到镇静和止痛系统的监视、处理和输出特征中的趋势分析。
现有技术的描述
已经开发出了一种镇静和止痛系统，其以一种安全的方式向经受疼痛、不舒服或其它可怕(产生焦虑)的医疗或手术过程的病人提供用于接受镇静、止痛和/或遗忘药物的装置，从而在有或没有许可的麻醉供应者存在时减小药物过量的风险。由于在技术上的明显进步，该镇静和止痛系统可以更安全地用于医院和流动环境，并且可以由个人操作，而不需要例如熟练的麻醉专家，C，R，N，A’s，熟练的医师，或其它熟练的操作者来操作。该镇静和止痛系统已经成功地满足不能为每个过程安排麻醉供应的从业者的需要，在所述过程中安全和有效的镇静和止痛能够基本上减轻恐惧和疼痛的影响。致力于这些目的而出现的镇静和止痛系统为这些人员提供了药物供给系统，该药物供给系统与病人监视系统集成在一起，减小了操作麻醉机所需要的脑力和体力工作负荷，同时使临床医师保持在病人管理的环节中。临床医师响应下面的“临床医生最知道”原则作出最后的决定。该先进的技术允许在没有麻醉供应的情况下以小于通常麻醉的药物效果来操作镇静和止痛系统，为病人提供经济的和易获得的镇静、遗忘和/或止痛手段。
在申请日为1999年6月3日、序列号为No.09/324,759的美国专利申请中描述了镇静和止痛系统的一个例子，并且将该专利申请整体上结合于此，作为参考。该镇静和止痛系统将例如一种或多种镇静、止痛和/或遗忘药物的供给、正气道压力的供给、药物供给的减小或增加、氧气供给，例如对阿片对抗剂的药物改变、从自病人监视装置出请求附加的信息、以及警报的触发与一个和多个病人生理状况的电子监视电气地集成在一起。在一种形式中，该专利申请的系统使用一组或多组反映病人和系统状态的存储的数据定义参数，所述参数通过软件被访问，以保存地控制药物供给并且将药物供给与关于有意识病人的生命体征和其它生理状况的安全、经济和最佳的值联系起来。
假监视数据或其它因素可以导致镇静和止痛系统采取潜在危险的动作，在关键情况下失灵，或者不必要地发出警报。例如，当心电图(ECG)变得不规则时，该镇静和止痛系统可以用心电图(ECG)监视病人的心率。当不规则ECG数据实际上是假的时，基于单个监视器，该镇静和止痛系统可以发出警报，该警报例如指示危险的低心率。频繁的假正性警报会干扰临床医师并且可能造成对危及生命的真实情况的更少关注。
通常，结合到医疗设备中的监视系统用专用监视器监视给定的病人参数。然后为监视的数据确定安全数据组，其中如果监视的数据落在安全范围之外，启动警报响应。该系统可以提供高灵敏度，其中多数真实的异常病人状况被检测到，然而，该系统也倾向于产生假正性(false positive)警报，该假正性警报由落在安全数据组之外的伪数据(data artifact)产生。而且，许多病人参数，例如心率，在即将来临的异常病人状况情况下，将以线性或单调方式朝着指示异常病人状况的安全数据组的阀值下降。在现有监视系统中，通常未检测到该下降，直到该数据在安全数据组之外；然而，随着时间从病人心率明显可以看出在病人参数实际落在安全数据组之外的之前几秒异常病人状况即将来临。一直等到数据超出确定的安全数据组阀值可能使临床医师遇上病人已经经历异常状况的情况。
                      发明内容
本发明包括能够以一种方式从与单个病人参数相关的单个监视器收集数据的镇静和止痛系统，其中所述方式减小了由于伪数据而导致的假正性警报响应的概率。本发明也包括能够检测即将来临的的异常病人状况的监视系统，其中所述状况可以在异常病人状况实际发生之前被检测到。
本发明也包括用于将趋势分析结合到镇静和止痛系统中的方法。在一个实施例中，该方法包括提供病人监视器以监视单个病人参数和利用该监视器监视病人，从而从该监视器收集的数据被传递到用于镇静和止痛系统的控制器。该方法进一步包括将该趋势输入到镇静和止痛系统的算法中或者分析该趋势。最后，该方法进一步包括基于所述趋势分析启动合适的动作。
                     附图说明
图1示出了根据本发明的镇静和止痛系统的一个实施例的方块图；
图2示出了根据本发明的心率趋势显示的一个例子；
图3示出了根据本发明的心率趋势显示的另一个例子；
图4显示了根据本发明的用于将趋势分析结合到镇静和止痛系统的一个实施例。
                    具体实施例方式
图1示出了根据本发明的镇静和止痛系统22的一个实施例的方块图，该系统具有用户接口12、软件控制的控制器14、外围设备15、电源16、外部通信10、压力供给11、病人接口17和药物供给19，其中镇静和止痛系统22由用户13操作，以便向病人18提供镇静和/或止痛。在申请日为1999年6月3日、序列号为No.09/324759的美国专利申请中公开和实现了镇静和止痛系统22的一个例子，并且将该专利申请整体上结合于此，作为参考。在申请日为2002年11月1日、序列号为No.10/285689的美国专利申请中公开和实现了用户接口的实施例，并且将专利申请整体上结合于此，作为参考。
病人接口17包括一个或多个病人健康监视器，例如生命体征监视器和意识监视器，包括但不限于无创血压监视器，脉氧计，二氧化碳监视仪，心电描记器(ECG)，病人意识评估系统，通气量监视器，通气压力监视器，阻抗体积描记器(IPG)，气体分析仪，通气温度监视器，通气湿度监视器，和听觉监视器。病人接口17的病人监视器可以电连接到控制器14并且提供代表病人实际生理状况的信号。在本发明的一个实施例中，至少一个监视器随着时间监视第一病人参数，其中该病人参数的趋势被分析，以确定异常病人状况是否即将来临和/或确定数据可能是伪数据还是表示真实病人状况。监视的参数例如可以包括心率、二氧化碳水平、氧饱和度、和血压。
在病人监视参数离开预定安全数据组之前(例如，心率下降到被认为太低的数值)通常伴有缓慢变化的时间段，即，趋势，其中该参数逐渐超出安全数据组阀值(例如心率缓慢下降)。缺少趋势分析，监视系统通常仅仅在参数落在其安全数据组之外时才警告临床医生，因此常常使主治人员穷于应付治疗已经潜在的危险情况。由系统22提供的趋势分析允许超前警告临床医师可能形成的潜在危险情况。进一步地，如果病人参数由于伪数据而落在安全数据组之外，那么本发明的趋势分析可以允许镇静和止痛系统识别该伪数据，所述伪数据由于缺少指示即将来临的异常病人状况的超前信息而产生。控制器14可以随着时间将来自病人接口17的电反馈和存储在存储设备中的数据进行比较，其中该数据可以作为信息的趋势而被评价而不是逐点评价。
控制器14可以被编程以响应趋势分析和/或储存的数据比较的结果而控制受动器(未示出)。受动器可以是能够保证病人安全和临床医师警觉的任何合适的控制特性。受动器包括但不限于：药物减少、药物增加、正气道压力变化、警报、预警报，氧气供给、触发从监视器的附加数据采样、例如对二氧化碳和阿片对抗剂的药物改变、和病人响应询问。受动器可以安静地改变而不警告主治医师；它们可以通过用户接口12发出信号；和/或它们可以在启动之前要求用户确认。
图2示出了显示30的一个实施例，该显示30示出了来自受监视的病人的心率趋势33。在所示的显示中，可以考虑用于给定病人的安全心率范围和临床环境，例如90-110bpm。趋势33可以基于心率y轴31和时间x轴32而建立。显示30进一步示出了时间段34，在该时间段，病人心率落在安全数据组中(在95bpm)并且预防警告临床医师和/或采取步骤将病人置于安全状态。时间段34之后，显示30示出了趋势33的时间段35。假设安全数据组被确定，时间段35落在可接受心率的范围之外。然而，假设缺少异常病人状况存在的支持证据，其中仅有一个数据点落在90bpm阀值下方并且没有与多数真实的临界异常病人状况一致的朝着阀值的斜下降，时间段35可能是伪数据导致的结果。在所举的例子期间警告临床医师可能导致假正性警报，从而减小了监视系统的特异性并且潜在地干扰了主治医师。连续启动的假正性警报可能导致临床医师更少地留心警报，而所述警报可能最终指示真实的异常病人状况。
图3示出了显示40的另一个例子，该显示40示出了来自受监视的病人的心率趋势43。在所示的显示中，可以考虑用于给定病人的安全心率范围和临床环境，例如90-110bpm。趋势43可以基于心率y轴41和时间x轴42而建立。显示40进一步示出了时间段44，其中时间段44表示病人心率落在安全数据组中(在100bpm)并且预防警告临床医师和/或采取步骤将病人置于安全状态。在时间段44之后，显示40示出了趋势43的时间段45。事件段45是趋势43的向下倾斜部分，其中时间段45最终超出确定的90bpm安全阀值。在所举的例子中，现有监视系统可能仅仅当时间段45最终超出90bpm的阀值才发出警报，其中该即将来临的情况本应当由于趋势形态而更早地被检测到。如这里将要进一步讨论的，通过在趋势分析中检测斜率变化，本发明能够在即将来临的异常病人状况充分发展之前检测到它们，从而给予了主治医师宝贵的时间以保证病人的安全。进一步地，基于时间段45的斜率，指示衰弱病人状况的该数据不可能由伪数据产生。通过将趋势分析结合到镇静和止痛系统22中，通过减小伪数据的影响，同时通过评价受监视病人参数的趋势而更早地捕捉真实的临界病人情况，本发明能够增强病人监视的特异性。
图4示出了用于将趋势分析结合到镇静和止痛系统22中的方法100的一个实施例。方法100包括步骤101，其包括提供病人监视器以监视给定的病人参数。步骤101的监视器例如可以是用来测量心率的脉氧计，然而，任何合适病人参数的任何合适的监视器都适用于本发明。步骤102包括用步骤101的监视器监视病人，其中从监视器收集的数据可以被传递到镇静和止痛系统22的控制器14(图1)。
步骤103包括基于从步骤101的监视器接收到的数据产生趋势分析。例如，图2和3示出了通过随着时间连接数据点而产生的趋势。该趋势可以通过任何合适的手段建立，其中该趋势可以进一步被显示以用于主治医师视觉分析。在步骤103之后，方法100可以进行步骤104和/或步骤105。
步骤104包括分析根据步骤103确定的趋势。例如，该趋势可以以下面的方式被分析：(1)如果趋势为线性、准线性或单调性质，则可以计算趋势的斜率以确定趋势是否逐渐不可动摇地朝着安全数据组的外界限行进；(2)如果趋势不趋向于沿着简单(例如，线性)路径，则可以计算趋势变化的多个斜率以确定趋势走向何方；(3)如果趋势是多项式性质，则可以计算多项式的系数以确定趋势的方向；和(4)使用最小均方误差技术和其它这样的算法来曲线拟合趋势并且预测是否以及何时它将超出安全数据组。根据该分析，本发明包括监视任何合适病人参数的趋势，该监视以指示真实病人状况的最精确描述的方式来进行。
根据步骤104，基于上述分析，方法100然后可以对照确定的安全数据组评价被监视的趋势。例如参考图3，如果阶段45的斜率超出特定比率，其中该斜率指示即将来临的异常病人状况，镇静和止痛系统22可以启动预警报或其它合适的动作，这将在这里进一步讨论。步骤104进一步包括通过本领域公知的方法为提供给控制器14的数据是否是斜率变化的真实指示而计算概率值。基于比较分析，如果该数据反映了斜率变化，则镇静和止痛系统22然后可以评价该数据，以确定该斜率是否指示即将来临的异常病人状况。进一步地，参考图2，该分析可以导致不予考虑时间段35作为伪数据，从而减小了镇静和止痛系统22启动假正性警报的可能性。甚至趋势分析结合到单个受监视的病人参数中可以有助于增加镇静和止痛系统22的特异性(通过减小伪数据的影响)和有助于在异常病人状况明显之前捕捉到它们。该趋势分析也可以应用到用于镇静和止痛系统22的多个参数并具有进一步有利的结果。
步骤105包括将步骤103产生的趋势输入到镇静和止痛系统22的任何合适的算法中。该趋势可以与来自相关病人参数的多个其它趋势组合以进一步减小伪数据的影响和通过传感器融合的结合而澄清不确定数据。进一步地，该趋势可以作为正交冗余特征而被结合，其中正交冗余表示用多个监视器同时监视单个病人参数。传感器融合进一步在申请日为2003年10月3日、名称为“用于提供传感器融和的系统和方法”的共同转让且待审的美国专利中被描述，将上述专利申请结合于此，作为参考。正交冗余监视进一步在申请日为2003年10月3日、名称为“用于在镇静和止痛系统中提供正交冗余监视的系统和方法”的共同转让且待审的美国专利中被描述，将上述专利申请结合于此，作为参考。通过减小启动假负性和假正性警报状态的可能性，趋势分析结合到该冗余中可以进一步增强镇静和止痛系统22的特异性和敏感性。该趋势也可以集成到神经网络中，其中神经网络是一种计算机化的智能，即使提供不完整或不明确的图像，神经网络也能够选出复杂模式和获得正确决定。
本发明包括将趋势分析结合到镇静和止痛系统22中，其中该集成可以允许控制器14更精确地分析关于病人状况的数据。通过监视给定的参数，能够消除假象的存在并且能够预测即将来临的异常病人情况，而且一个趋势与监视单个参数的多个趋势，监视多个相关参数的多个趋势，以及神经网络的配合使用进一步增强了镇静和止痛系统22基于病人状况的真实图像采取动作的能力。根据步骤105基于与镇静和止痛系统22相关的算法而采取的这些动作包括如步骤106所述的动作以及有助于保证病人安全的任何其它合适的动作。
步骤106包括基于步骤104的趋势分析采取合适的动作。如果，例如根据趋势分析确定在安全数据组之外的数据是由于假象(例如图2)，则方法100可以进行步骤102，并且镇静和止痛系统22可以不采取其它动作。在伪数据存在的情况下，保持正常功能可以减小假正性警报的概率，并且可以允许镇静和止痛系统更直接地监视实际病人状况。如果在趋势分析的基础上确定异常病人情况是即将来临的(例如图3)，步骤106包括启动预警报。预警报可以是任何合适的动作，采取上述动作来警告主治医师即将来临的异常病人状况的高概率。该预警报可以可视地和/或可听地发出信号，并且例如可以包括减小药物水平；例如对二氧化碳和/或阿片对抗剂的药物改变；触发从病人监视器的附加数据的采样；供给氧气；测试病人响应；和供给正气道压力。如果病人超出确定安全阀值也可以采取这些动作，其中用于该情况的警报例如可以比相关的预警报更显著。通过基于趋势分析而在早期采取动作，镇静和止痛系统22可以警告临床医师早早地和潜在地同时避免许多异常病人状况。例如，如果代表心率的趋势指示心率陡峭地下降并且不是由于假象，镇静和止痛系统22可以在病人心率落在确定的安全数据组之外之前暂停药物供给。该提前动作可以避免或减小异常病人状况的严重性。
尽管已经在这里显示和描述了本发明的典型实施例，本领域的熟练技术人员可以明显看出这些实施例仅仅作为例子而提供。多种无实质的变化、改变和代替现在对于本领域的熟练技术人员来说是显而易见的并且不超出由申请人在这里公开的本发明的范围。因此，这意味着当权利要求被允许时本发明仅仅由权利要求的精神和范围限定。

Claims (14)

1、一种镇静和止痛系统，包括：
至少一个病人健康监视设备，用于耦合到病人并且测量一个病人参数，其中所述病人参数反映所述病人的生理状况；
用户接口；
药物供给控制器，用于向所述病人供应一种或多种药物；
存储设备，用于存储安全数据集，所述安全数据集反映所述监视的病人生理状况其中至少一个的安全的和不期望的参数；和
电子控制器，其与所述病人健康监视设备、所述用户接口、所述药物供给控制器和所述存储设备相互连接，其中所述电子控制器接收所述病人参数并且分析所述病人参数的趋势，以确定异常病人状况是否即将来临。
2、根据权利要求1的镇静和止痛系统，还包括一个或多个受动器，用于保证病人安全和临床医师觉察，其中所述电子控制器与该受动器相互连接并且根据所述病人参数的所述趋势控制该受动器。
3、根据权利要求1的镇静和止痛系统，其中，所述电子控制器响应于在所述安全数据集范围内的所述病人参数的异常趋势，来提供预先警报。
4、根据权利要求1的镇静和止痛系统，其中，所述电子控制器对照所述趋势来评价所述病人参数的测量。
5、根据权利要求1的镇静和止痛系统，其中，所述病人参数是从二氧化碳测定、脉氧测定和血压得到的一个参数。
6、根据权利要求1的镇静和止痛系统，其中，所述病人参数是心率。
7、根据权利要求1的镇静和止痛系统，其中，所述至少一个病人健康监视设备是心电描记器和脉氧计中的一个。
8、一种用于将趋势分析结合到镇静和止痛系统中的方法，包括以下步骤：
提供病人监视器以监视单个病人参数；
利用该监视器监视病人，其中从该监视器收集的数据可以被传递到所述镇静和止痛系统的控制器；
基于从所述监视器接收的数据，来产生趋势；
将该趋势输入到镇静和止痛系统的算法中或/和分析该趋势；和
基于所述趋势分析，启动合适的动作。
9、根据权利要求8的方法，其中，所述分析步骤包括下列至少一个：计算趋势的斜率；为趋势变化计算多个斜率；计算多项式的系数；和使用最小均方误差技术来曲线拟合斜率。
10、根据权利要求8的方法，还包括步骤：为提供给控制器的数据是否是斜率变化的真实指示来计算概率值。
11、根据权利要求8的方法，其中，结合来自相关病人参数的多个其它趋势来分析所述趋势。
12、根据权利要求9的方法，其中，所述趋势被结合作为正交冗余特征。
13、根据权利要求8的方法，其中，所述趋势被集成到至少一个神经网络中。
14、根据权利要求8的方法，其中所述合适的动作包括下列至少一个：继续监视；启动预警报；暂停药物供给；和启动全警报。
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