CN101102812A - 用于心跳校准和比较的方法和设备 - Google Patents

用于心跳校准和比较的方法和设备 Download PDF

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CN101102812A
CN101102812A CNA2005800406902A CN200580040690A CN101102812A CN 101102812 A CN101102812 A CN 101102812A CN A2005800406902 A CNA2005800406902 A CN A2005800406902A CN 200580040690 A CN200580040690 A CN 200580040690A CN 101102812 A CN101102812 A CN 101102812A
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template
obtains
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CN101102812B (zh
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S·帕尔雷迪
J·A·沃伦
A·H·奥斯特洛夫
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Cameron Health Inc
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/35—Detecting specific parameters of the electrocardiograph cycle by template matching
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/363—Detecting tachycardia or bradycardia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3622—Heart stimulators for treating or preventing abnormally high heart rate comprising two or more electrodes co-operating with different heart regions
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/92—Computer assisted medical diagnostics

Abstract

利用具有模板数据集和模板参数的模板提供获取的心脏信号数据对存储模板的改进校准的方法。更具体地说，在说明性方法中，首先利用存储模板的模板参数配置获取的心脏信号。然后，一旦配置完成，就将获取的心脏信号与存储模板进行比较。其它实施例包括可植入心脏治疗装置，该装置包括配置为执行该说明性方法的操作电路。在其它实施例中，可使用多于一个存储模板。每个模板可具有独立构造的模板，使得单个获取的心脏信号可以利用与第一模板比较的第一参数配置，以及利用与第二模板比较的第二参数配置。

Description

用于心跳校准和比较的方法和设备
相关申请
本发明涉及2004年11月29日提交的题为“METHOD FORDEFINING SIGNAL TEMPLATES IN IMPLANTABLE CARDIACDEVICES”的美国专利申请No.10/999,853，该公开通过引用结合于本文中。
技术领域
本发明涉及电心脏治疗和装置领域。更具体地说，本发明涉及电心脏信号的分析用于诊断/治疗目的。
背景技术
可植入心律管理装置在管理特定患者不规则的心律时是一种有效的治疗。可植入心律管理装置能够用各种疗法识别和治疗心律失常。但是，为了有效地提供这些疗法，心律管理装置必须首先必须准确地对急性发作进行感测和分类。
为了响应于急性发作而应用合适的疗法，一些心律管理装置对感测的心脏信号与先前存储的代表正常窦性心律(NSR)的″模板″或常常用于表示患者NSR的其它″模板″进行比较。当心律管理装置不正确地对感测的心脏复合波与存储的NSR模板进行比较，并且因此对感测的心脏复合波错误分类时，问题出现了。如果心律管理装置由于错误分类而不适当地提供和/或抑制疗法，则此问题的严重程度逐步升高。作为例证说明，当由于对模板不适当的校准的原因，感测的复合波的特定组错误地与存储的模板进行了比较，则心律管理装置可能错误地将这些感测的复合波分类为不匹配，并且甚至可能分类为快速性心律失常。
对心脏信号执行的大多数分析包括对心脏信号采样并将采样信号与存储模板进行比较。因此，一系列采样信号与存储数据进行比较。常常执行相关性分析以比较这两个数据集。一般地，每个信号中将出现多个峰值。如果峰值校准不良，则将常常导致低相关性。由于不良的校准，″好的″采样信号可能在分析中给出弱相关，错误地指示治疗。因此期望允许并保证良好校准的技术。
发明内容
本发明在说明性实施例中，利用具有模板数据集和模板参数的模板，以提供对获取的心脏信号数据与存储模板的改进校准。更具体地说，在说明性的方法中，首先利用存储模板的模板参数配置获取的心脏信号。然后，一旦配置完成，就将获取的心脏信号与存储的模板进行比较。其它实施例包括可植入心脏治疗装置，该装置包括配置为执行所述说明性方法的操作电路。
在其它实施例中，可以使用多于一个存储模板。每个模板能够具有独立构造的模板，使得单个获取的心脏信号可以利用与第一模板比较的第一参数配置，并且利用与第二模板比较的第二参数配置。
附图说明
图1A-1B分别说明代表性的皮下和静脉内可植入心脏治疗系统；
图2是说明性模板形成方法的框图；
图3是说明性实施例的框图；以及
图4A-4E用图表显示用于获取、校准和比较心脏信号的说明性方法。
具体实施方式
以下详细说明应该参考附图阅读。不一定按比例绘制的附图给出了说明性实施例并且不旨在限制本发明的范围。本领域技术人员将认识到，提供的许多实例具有可以利用的适当替代方案。
本发明一般涉及可植入心脏治疗系统，该系统为经历特定心律失常的患者提供疗法。本发明针对在心律装置中使用的检测结构。具体地说，本发明适合于可植入心脏治疗系统，它能够检测和治疗有害的心律失常。尽管检测结构主要旨在供提供除颤疗法的可植入医疗装置中使用，但本发明也适于针对抗快速性心律失常起搏(ATP)疗法、起搏的心律装置(包括外部装置)、以及能够执行治疗心律失调的疗法组合的其它心律装置。
迄今为止，可植入心脏治疗系统已经是心外膜系统或经静脉系统。例如，经静脉系统能够一般如图1B所示植入。但是，如本文进一步解释的，本发明也适合于具有皮下可植入心脏治疗系统的功能，如图1A所示。
图1A说明皮下放置的可植入心脏治疗系统，具体地说，说明一种可植入心律转变器/除颤器(ICD)系统。在此说明性实施例中，利用连接到引线系统14的罐12监控心脏10。罐12其上可包括电极16，而引线系统14连接到感测电极18、20和线圈电极22，它可充当电震或刺激传递电极以及感测电极。各种电极定义多个感测矢量V1、V2、V3、V4。可见，每个矢量提供心脏10电活动的不同矢量“视图”。系统可以经皮下植入，如例如在美国专利No.6,647,292和6,721,597中说明的，以上两个专利都通过引用结合于本文中。通过皮下放置，这意味着电极放置不需要将电极插入到心室中、插入到心肌中或心肌上、或者插入到患者的脉管系统。在一些实施例中，利用罐电极12和引线系统电极18、20或22之一，常常是线圈电极22，施加电震。在其它实施例中，感测电极18、20之一可以与线圈电极22结合使用来提供电震。
图1B说明经静脉的ICD系统。监控心脏30并且用包括连接到引线系统34的罐32的系统治疗心脏30，引线系统34包括心房电极36和心室电极38。可以使用多种电极配置，包括放置在心脏内、粘附到心脏、或者设置在患者的脉管系统内。
图2是说明性的模板形成方法的框图。说明性方法从开始框40开始，并且第一步骤为对信号42采样。信号可以例如利用皮下、经静脉、心外膜、心脏内的乃至外部电极获取。然后，说明性模板形成方法定义模板参数44。说明性包括在定义模板参数44中的是如下步骤：选择基准点46以及围绕基准点定义模板窗48。
利用定义的模板参数以及选择的样本，说明性模板形成方法中的下一步骤是检验模板50。此步骤50可包括模板数据的统计分析，将模板与稍后的采样信号进行比较，或者能够保证模板提供良性心律的精确表示的其它步骤。如果模板在50检验了，则它通过并且如52所示存储。然后能完成模板形成的方法，如54所示。模板存储为模板数据集和模板参数。如果模板在50无法检验，则它失败，并且方法返回到开始40。在一些实施例中，周期性地出现形成模板的尝试，并且如果形成方法失败，则方法完成54，直到提示稍后重新开始。
可以用许多不同的方式执行选择基准点46，例如在2004年11月29日提交的题为“METHOD FOR DEFINING SIGNALTEMPLATES IN IMPLANTABLE CARDIAC DEVICES”的未决美国专利申请No.10/999,853中论述的。例如，可以选择信号中的最大正或者负峰值。或者，可以选择出现在特定时间的峰值(例如感测信号中的第一有效峰值)。在备选实施例中，可以选择一阶导数或者更可能的二阶导数中的峰值或零。
在一些方法中，通过标识QRS信号的开始和结束来执行围绕基准点设置模板窗的步骤70。观察单调段可用来估算QRS段的开始和结束，如在2004年11月29日提交的题为“METHOD FOR DEFININGSIGNAL TEMPLATES IN IMPLANTABLE CARDIAC DEVICES”的未决美国专利申请No.10/999,853中进一步解释的。单调段是其中感测的振幅以相同方向改变或者保持不变的连续样本的信号段。例如，其中每个连续样本大于或等于(在振幅上)先前样本的一系列连续样本会是单调递增段。类似地，其中每个连续样本小于或等于(在振幅上)先前样本的一系列连续样本会是单调递减段。观察单调段的一个方法是确定心脏复合波信号的一阶导数的过零点。感测信号中在基准点之前出现的最大单调段可以假定代表QRS复合波的开始，而基准点之后出现的最大单调段然后可以假定代表QRS复合波的结束。可以观察样本点中超过这些开始和结束点的一个、两个或者其它数量的样本点，用于保留在模板窗中。
对于另一个实例，给定感测信号中的等电线，可以记录下等电线的交叉点数量。在至少最低量的间隔出现的连续交叉点可表示Q-R和R-S间隔，使得QRS信号可以标识为包括连续交叉点加上往返预定数量样本如三个样本的数据样本。
图2所示的方法仅仅说明模板形成的一种形成。对于本发明，充分的是，形成或已经形成了具有模板数据集和模板参数的特制模板。一旦形成，模板然后就能如下进一步说明的使用。
图3是说明性实施例的框图。方法从检测“接通”以使心脏信号被监控开始60。当感测到心跳(或者其它事件)时，如62所示，方法则包括保存所监控心脏信号的多个样本64。可以用任何适当的方式感测心跳(或者其它事件)。如果期望，2004年6月1日提交的题为“METHOD AND DEVICES FOR PERFORMING CARDIACWAVEFORM APPRAISAL”的未决美国专利申请No.10/858,598的方法可用来检验感测信号是否可能对应于心脏事件和/或心室事件。美国专利申请No.10/858,598的公开通过引用结合于本文中。如果感测信号确实可能对应于这种事件，则可选择该信号作进一步分析。
接下来，根据预定模板参数，在66定义模板窗。模板窗口定义可包括标识基准点68以及围绕该基准点设置窗70。接下来，执行比较72。比较结果可以各种方式使用。相关波形分析是可以执行的一种类型比较。说明性的比较类型和使用示于在2004年5月27日提交的题为“METHOD FOR DISCRIMINATING BETWEENVENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS”的未决美国申请No.10/856,084，该申请的公开通过引用结合于本文中。在这里也可以利用其它常规的比较及其使用。
图4A-4E用图表显示用于获取、校准和比较心脏信号与模板的说明性方法。图4A图解感测信号80，它可以作为心跳检测。如图4B所示，多个样本82用来离散地获取心跳。图4C显示，根据样本82，基准点84已经选择为信号从等电线的最大正偏移的峰值。图4D图解样本82的开窗，其中窗86围绕基准点84定义。因为信号具有相对大的拖曳部分，因此基准点84从窗86的中心位移一个偏移量。利用在形成模板本身时定义的模板参数，执行选择基准点和定义其周围的窗(以及偏移量)的步骤。
接下来，如图4E所示，将样本与模板校准。更具体地说，样本基准点84与模板基准点90校准。然后校准模板和样本窗的前沿92和后沿94。然后可以执行比较96。通过不仅校准基准点84、90，而且重新配置样本窗并匹配样本窗与用于产生模板的那个，该方法有利地将比较96集中在可得到的最相关和有用的数据上。
本发明在一些实施例中也实施在利用操作电路的装置中，操作电路包括在罐12(图1A)或者罐32(图1B)内提供的选择电元件。在这种实施例中，操作电路可以配置为允许执行以上方法。在一些类似的实施例中，本发明可以实施为可读指令集，比如在机器或控制器可读介质中编码的程序，其中提供可读指令集以允许操作电路执行上述实施例中论述的分析。其它实施例可包括控制器或者微控制器，它们适合于读出并且执行以上方法。这些各种实施例可结合例如如图2、3和4A-4E所示的说明性方法。
以下说明性的实施例根据操作电路解释。操作电路可以配置为按照选择、需要或者期望，包括这种控制器、微控制器、逻辑器件、存储器等，用于执行为其修改和配置的方法步骤。
本发明的说明性实施例包括可植入心律转变器/除颤器，它包括含有多个电极的引线电极组件以及安放操作电路的罐，其中引线电极组件连接到罐。在说明性实施例中，操作电路配置为利用具有模板数据集和模板参数的模板分析心脏事件，且操作电路配置为执行如下步骤：利用植入在患者躯干中的电极获取信号；根据模板参数配置获取的信号；校准模板数据集和获取的信号；以及比较模板数据集和获取的信号。
在另一实施例中，操作电路还配置为执行如下步骤：将获取的信号分类为正常或者异常。在另一个实施例中，操作电路配置为使得模板参数包括选择模板和获取信号的基准点的方式。在再一个实施例中，操作电路配置为使得模板参数包括围绕获取信号的基准点选择数据点的方式。
在另一个实施例中，操作电路还配置为使得模板参数包括选择形成模板窗的数据点的方式。对于另一个实施例，操作电路还配置为执行利用皮下植入的电极获取信号的步骤。在又一个实施例中，操作电路还配置为使得：模板包括用模板参数定义的模板数据集内的基准点；模板数据集包括相对基准点的开始点和结束点，开始点和结束点的放置由模板参数定义；以及配置获取信号的步骤包括：在获取信号中选择基准点；以及根据模板数据集的开始点和结束点的放置标识获取信号的开始点和结束点。
在又一个设备实施例中，操作电路还配置为使得比较模板数据集与获取信号的步骤包括执行在其开始点和结束点之间定义的获取信号和模板数据集之间的相关波形分析。操作电路可包括微控制器。在另一个实施例中，操作电路包括可读介质，可读介质包括用于执行获取、配置、校准和比较步骤的指令集。
本发明的实施例可包括可植入心律转变器/除颤器，可植入心律转变器/除颤器包括：含有多个电极的引线电极组件；以及安放操作电路的罐，其中：引线电极组件连接到罐；操作电路配置为利用具有模板数据集和模板参数的模板分析心脏事件；且操作电路配置为执行多个步骤。在说明性实施例中，步骤可包括对于多个选择的获取心脏信号的如下步骤：根据模板参数配置获取信号，校准模板数据集与获取信号，以及比较模板数据集和获取信号。操作电路可以还配置为跟踪正常和异常获取信号的数量，以及确定是否指示疗法。
在另一个实施例中，操作电路还配置为使得配置步骤包括在选择的获取心脏信号中标识基准点。在另一个实施例中，操作电路还配置为执行如下步骤：获取多个心脏信号；分析各个获取的心脏信号，以确定获取的心脏信号是否可能代表心脏事件；以及选择可能代表心脏事件的那些各个获取的心脏信号。
本领域技术人员将认识到，本发明可以用不同于在本文中描述和设想的特定实施例的各种形式表现。因此，可以进行形式和细节的偏离，并不背离在所附权利要求中描述的本发明的范围和精神。

Claims (24)

1.一种利用具有模板数据集和模板参数的模板分析心脏事件的方法，所述方法包括：
利用植入在患者躯干中的电极获取信号；
根据所述模板参数配置所述获取信号；
校准所述模板数据集和所述获取信号；以及
比较所述模板数据集和所述获取信号。
2.如权利要求1所述的方法，还包括将所述获取信号分类为正常或者异常。
3.如权利要求1所述的方法，其中所述模板参数包括选择所述模板和所述获取信号的基准点的方式。
4.如权利要求3所述的方法，其中所述模板参数包括围绕所述获取信号的基准点选择数据点的方式。
5.如权利要求1所述的方法，其中所述模板参数包括选择形成模板窗的数据点的方式。
6.如权利要求1所述的方法，其中利用皮下植入的电极执行获取信号的步骤。
7.如权利要求1所述的方法，其中：
所述模板包括用所述模板参数定义的模板数据集内的基准点；
所述模板数据集包括相对所述基准点的开始点和结束点，所述开始点和结束点的放置由所述模板参数定义；以及
所述配置获取信号的步骤包括：
在所述获取信号中选择基准点；以及
根据所述模板数据集的开始点和结束点的放置标识所述获取信号的开始点和结束点。
8.如权利要求7所述的方法，其中所述比较所述模板数据集与所述获取信号的步骤包括执行在其开始点和结束点之间定义的获取信号和所述模板数据集之间的相关波形分析。
9.一种利用具有模板数据集和模板参数集合的模板分析患者心律的方法，所述方法包括：
对多个选择的获取心脏信号执行以下方法步骤：
a.根据所述模板参数配置获取信号；
b.校准所述模板数据集和所述获取信号；以及
c.比较所述模板数据集和所述获取信号，以确定所述获取信号是正常还是异常；
跟踪正常和异常获取信号的数量；以及
确定是否指示疗法。
10.如权利要求9所述的方法，其中所述配置步骤包括标识所述选择的获取心脏信号中的基准点。
11.如权利要求10所述的方法，还包括：
获取多个心脏信号；
分析各个获取心脏信号，以确定所述获取心脏信号是否可能代表心脏事件；以及
选择可能代表心脏事件的那些各个获取心脏信号。
12.一种可植入心律转变器/除颤器，包括：
引线电极组件，包括多个电极；以及
罐，安放操作电路；
其中：
所述引线电极组件连接到所述罐；
所述操作电路配置为利用具有模板数据集和模板参数的模板分析心脏事件；以及
所述操作电路配置为执行如下步骤：
利用植入在患者躯干中的电极获取信号；
根据所述模板参数配置所述获取信号；
校准所述模板数据集和所述获取信号；以及
比较所述模板数据集和所述获取信号。
13.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路还配置为执行如下步骤：将所述获取信号分类为正常或者异常。
14.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路配置为使得所述模板参数包括选择所述模板和所述获取信号的基准点的方式。
15.如权利要求14所述的可植入心律转变器/除颤器，其中所述操作电路配置为使得所述模板参数包括围绕所述获取信号的基准点选择数据点的方式。
16.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路还配置为使得所述模板参数包括选择形成模板窗的数据点的方式。
17.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路还配置为执行利用皮下植入的电极获取信号的步骤。
18.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路还配置为使得：
所述模板包括用所述模板参数定义的模板数据集内的基准点；
所述模板数据集包括相对所述基准点的开始点和结束点，所述开始点和结束点的放置由所述模板参数定义；以及
配置所述获取信号的步骤包括：
在所述获取信号中选择基准点；以及
根据所述模板数据集的开始点和结束点的放置标识所述获取信号的开始点和结束点。
19.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路还配置为使得所述比较所述模板数据集与所述获取信号的步骤包括执行在其开始点和结束点之间定义的所述获取信号和所述模板数据集之间的相关波形分析。
20.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路包括微控制器。
21.如权利要求12所述的可植入心律转变器/除颤器，其中所述操作电路包括可读介质，所述可读介质包括用于执行所述获取、配置、校准和比较步骤的指令集。
22.一种可植入心律转变器/除颤器，包括：
引线电极组件，包括多个电极；以及
罐，安放操作电路；
其中：
所述引线电极组件连接到所述罐；
所述操作电路配置为利用具有模板数据集和模板参数的模板分析心脏事件；以及
所述操作电路配置为执行如下步骤：
对于多个选择的获取心脏信号，步骤为：
a.根据所述模板参数配置获取信号；
b.校准所述模板数据集和所述获取信号；以及
c.比较所述模板数据集和所述获取信号，以确定所述获取信号是正常还是异常；
跟踪正常和异常获取信号的数量；以及
确定是否指示疗法。
23.如权利要求22所述的可植入心律转变器/除颤器，其中所述操作电路还配置为使得所述配置步骤包括标识所述选择的获取心脏信号中的基准点。
24.如权利要求23所述的可植入心律转变器/除颤器，其中所述操作电路还配置为执行如下步骤：
获取多个心脏信号；
分析各个获取心脏信号，以确定所述获取心脏信号是否可能代表心脏事件；以及
选择可能代表心脏事件的那些各个获取心脏信号。
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