CN107073275A - 具有触发的消隐周期的医疗设备 - Google Patents

具有触发的消隐周期的医疗设备 Download PDF

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CN107073275A
CN107073275A CN201580057742.0A CN201580057742A CN107073275A CN 107073275 A CN107073275 A CN 107073275A CN 201580057742 A CN201580057742 A CN 201580057742A CN 107073275 A CN107073275 A CN 107073275A
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heartbeat
medical device
implantable medical
heart
patient
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CN107073275B (zh
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杰弗瑞·E·施塔尔曼
迈克尔·J·凯恩
保罗·荷斯康
基思·R·迈莱
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Cardiac Pacemakers Inc
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    • 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
    • A61N1/3925—Monitoring; Protecting
    • 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
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37288—Communication to several implantable medical devices within one patient
    • 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
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators
    • 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
    • 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
    • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • 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
    • A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
    • A61N1/39622—Pacing therapy

Abstract

一种植入式心律系统包括：第一植入式医疗设备，其被配置为从第一位置检测第一心跳；以及第二植入式医疗设备，其被配置为从第二位置检测患者的第一心跳。第二植入式医疗设备在检测第一心跳之后，可以发送所检测到的第一心跳的指示到第一植入式医疗设备，并且作为响应，第一植入式医疗设备开始具有消隐周期持续时间的消隐周期使得检测到的第一心跳的T波被第一植入式医疗设备消隐以便不被解释为后续第二心跳。在一些实例中，第一植入式医疗设备是SICD以及第二植入式医疗设备是LCP。

Description

具有触发的消隐周期的医疗设备
相关申请的交叉引用
本申请要求2014年8月28日递交的美国临时专利申请序列号62/043,106的权益，通过参考的方式将该公开并入本文。
技术领域
本公开整体涉及植入式医疗设备并且更具体地涉及用于改善植入式医疗设备的效率的方法和系统。
背景技术
起搏设备可以用于治疗这样一种患者即该患者遭受可能导致心脏传递足够量的血液到患者身体的能力降低的各种心脏状况。该心脏状况可能导致快速的、无规律的和/或不足够的心脏收缩。为了助于减轻这些条件中的一些，各种设备(例如起搏器、除颤器、传感器等等)可以被植入到患者的身体中。该设备可以监视并且提供电刺激到心脏，以助于心脏以更正常、有效和/或安全的方式来操作。在一些情况中，患者可以具有多个植入设备，其被配置为进行通信以助于监视患者状况和/或传递有效的疗法。
发明内容
本公开整体涉及植入式医疗设备并且更具体地涉及用于改善植入式医疗设备的效率的方法和系统。
在第一实例中，一种植入式心律系统包括：第一植入式医疗设备，其被配置为监视患者的心律并且提供休克疗法以纠正患者的心律；以及第二植入式医疗设备，其被配置为至少感测患者的心脏。第一植入式医疗设备被配置为从第一位置检测患者的第一心跳，以及第二植入式医疗设备被配置为从第二位置检测患者的第一心跳。第二植入式医疗设备在检测第一心跳之后，可以发送所检测到的第一心跳的指示到第一植入式医疗设备，并且作为响应，第一植入式医疗设备可以开始具有消隐周期持续时间的消隐周期使得检测到的第一心跳的T波被第一植入式医疗设备消隐以便不被解释为后续第二心跳。
可替换地或另外地以及在第二实例中，第一实例的第一植入式医疗设备包括除颤器和复律器。
可替换地或另外地以及在第三实例中，第一实例或第二实例的第一植入式医疗设备包括皮下复律器。
可替换地或另外地以及在第四实例中，第一实例到第三实例中的任意一个的第二植入式医疗设备可选择地包括无引线心脏起搏器。
可替换地或另外地以及在第五实例中，第一实例到第四实例中的任意一个的第二植入式医疗设备经由传导通信与第一植入式医疗设备通信。
可替换地或另外地以及在第六实例中，第一实例到第五实例中的任意一个的发送的检测到的第一心跳的指示包括R波检测标记。
可替换地或另外地以及在第七实例中，至少部分地基于由第一植入式医疗设备和第二植入式医疗设备中的一个或两个检测到的当前心率，设置第一实例到第六实例中的任意一个的消隐周期持续时间。
可替换地或另外地以及在第八实例中，基于检测到的第一心跳是内在心跳还是起搏心跳，设置第一实例到第七实例中的任意一个的消隐周期持续时间。
可替换地或另外地以及在第九实例中，在从第二植入式医疗设备接收到检测到的第一心跳的指示之后，第一实例到第八实例中的任意一个的第一植入式医疗设备对于在开始消隐周期之前的消隐时间延迟，继续尝试从第一位置检测患者的第一心跳。
可替换地或另外地以及在第十实例中，第一实例到第九实例中的任意一个的消隐时间延迟取决于患者的当前心率。
可替换地或另外地以及在第十一实例中，第一实例到第十实例中的任意一个的第一位置在患者心脏外，以及第二位置在患者心脏内。
可替换地或另外地以及在第十二实例中，第一实例到第十一实例中的任意一个的第一位置在患者胸腔外，以及第二位置在患者心脏的腔室内。
第十三实例是一种植入式医疗设备，包括：一个或多个电极，用于检测患者的心跳；以及接收器，用于经由传导通信从另一个医疗设备接收检测到的心跳的指示。植入式医疗设备响应于接收到检测到的心跳的指示，开始具有消隐周期持续时间的消隐周期。植入式医疗设备被配置为在消隐周期持续时间期间经由植入式医疗设备的一个或多个电极不识别患者的后续心跳。
可替换地或另外地以及在第十四实例中，响应于接收到检测到的心跳的指示，第十三实例的植入式医疗设备对于在开始消隐周期之前的消隐时间延迟，继续感测患者的心跳。
可替换地或另外地以及在第十五实例中，第十三实例到第十四实例中的任意一个的植入式医疗设备中，至少部分地基于患者的当前心率来检测消隐周期持续时间。
可替换地或另外地以及在第十六实例中，第十三实例到第十五实例中的任意一个的植入式医疗设备中，至少部分地基于检测到的心跳是内在心跳还是起搏心跳来设置消隐周期持续时间。
可替换地或另外地以及在第十七实例中，第十三实例到第十六实例中的任意一个的植入式医疗设备是皮下植入式复律器，并且另一个医疗设备是无引线心脏起搏器。
可替换地或另外地以及在第十八实例中，第十三实例到第十七实例中的任意一个的植入式医疗设备中，接收到的检测到的心跳的指示包括R波检测标记。
实例十九是一种使用来自无引线心脏起搏器的数据来改善皮下植入式复律器的性能的方法。经由无引线心脏起搏器检测第一心跳。经由皮下植入式复律器检测第一心跳。发送由无引线心脏起搏器检测到的第一心跳的指示到皮下植入式复律器。皮下植入式复律器开始消隐周期使得检测到的第一心跳的T波被皮下植入式复律器消隐从而不被解释为后续第二心跳。
可替换地或另外地以及在第二十实例中，第十九实例的消隐周期被配置为使得后续心跳将由皮下植入式复律器看到。
以上摘要不是意图描述本公开的每个实施方式或者每个实现。通过参考结合附图给出的以下描述和权利要求，本公开的优点和成就以及更完整的理解将变得显而易见和可理解。
附图说明
结合附图来考虑各种示例性实施方式的以下描述可以更完整地理解本公开，其中：
图1是根据本公开的一个实例的植入式心律系统的示意性说明；
图2是示出了图1的植入式心律系统的使用的图；
图3是示出了图1的植入式心律系统的使用的图；
图4是根据本公开的一个实例的植入式医疗设备的示意图；
图5是根据本公开的一个实例的说明性无引线心脏起搏器(LCP)的示意性方框图；
图6是可以结合图5的LCP使用的另一个说明性医疗设备的示意性方框图；
图7是包括彼此通信的多个LCP和/或其他设备的示例性医疗系统的示意图；
图8是根据本公开的另一个实例的包括LCP和另一个医疗设备的系统的示意图；
图9是根据本公开的另一个实例的包括LCP和另一个医疗设备的系统的示意图；以及
图10是可以由医疗设备如图1-图8中所示的那些医疗设备实现的说明性方法的流程图。
虽然本公开可以有各种修改和替换形式，细节已通过附图中的实例来显示并且将详细描述。然而，应该理解其意图不是为了将本公开的方案限制为所述具体说明性实施方式。相反，其意图在于覆盖落入本公开的精神和范围之内的全部修改、等效物和替换物。
具体实施方式
应当参考附图来阅读以下的描述，其中在不同附图中相同的元件被相同地标号。说明书和无需按比例绘制的附图描述了说明性的实施方式并且不意图限制本公开的范围。
正常健康的心脏通过遍及心脏传导内在地生成的电信号来引起收缩。这些内在信号导致心脏的组织或肌肉细胞收缩。该收缩迫使血液走出和进入心脏，提供血液遍及身体的其余部分的循环。然而，许多患者遭受影响他们心脏的该收缩性的心脏条件。一些心脏可能例如发展出不再生成或者传导内在电信号的病变组织。在一些实例中，病变心脏组织以不同速率传递电信号，因而导致心脏的不同步并且不足够的收缩。在其他实例中，心脏可能以使得心率变得低得危险的低速率来生成内在信号。在其他实例中，心脏可能以异常高的速率生成电信号。在一些情况中，该异常可能发展成室颤状态，其中，患者的心室的收缩几乎完全不同步并且心脏泵送非常少血液乃至不泵送血液。可以被配置为确定该心脏异常或心律不齐的发生并且传递一种或多种类型的电刺激疗法到患者心脏的植入式医疗设备可以助于终止或减轻该心脏条件。
可以部署包括各种植入式医疗设备的多种不同的医疗设备来监视心脏事件以及当合适时提供疗法。图1提供了包括第一植入式设备12和第二植入式设备14的植入式心律系统10的示意性说明。在一些实施例中，第一植入式设备12可以被配置为监视患者的心律并且提供休克疗法以纠正患者的心率。在一些实施例中，第二植入式设备14可以被配置为感测(以及有时候起搏)患者的心脏。
第一植入式设备12可以被配置为从第一位置检测患者的第一心跳，而第二植入式设备14可以被配置为从第二位置检测患者的相同的第一心跳，其中，第二位置与第一位置不同。例如，在一些实施例中，第一位置在患者心脏外，而第二位置在患者心脏内。在一些实施例中，第一位置在患者胸腔外，以及第二位置在患者心脏的腔室内。在第二植入式设备14检测到第一心跳之后，第二植入式设备14可以发送检测到的第一心跳的指示到第一植入式设备12，并且作为响应，第一植入式设备12可以开始具有消隐周期持续时间的消隐周期使得检测到的第一心跳的T波被第一植入式医疗设备12消隐以便不被解释为后续第二心跳。在一些实施例中，第二植入式设备14经由传导通信与第一植入式设备12通信。在一些实施例中，从第二植入式设备14发送到第一植入式设备12的、检测到的第一心跳的发送的指示包括R波检测标记。R波检测标记可以向第一植入式设备12通知由第二植入式设备14检测到的第一心跳的R波的出现，并且在一些情况中当R波出现时(即经由时间戳等等)。在一些情况中，R波检测标记可以提供附加的信息如当前检测心跳速率(例如以前检测的R波与当前检测的R波之间的时间)和/或任意其他合适的信息。
第一植入式设备12和第二植入式设备14可以是任意希望的植入式设备。在一些实施例中，第一植入式设备12可以是除颤器或复律器。在一些实施例中，第一植入式设备12可以是皮下复律器，其具有放置在胸腔外的感测电极。在一些实施例中，第二植入式设备14可以是放置在心脏中或上的无引线心脏起搏器。
关于图2和3示出了说明性的消隐周期。图2提供了对应于LCP R波感测事件18的LCP(无引线心脏起搏器)心电图16、SICD(皮下植入式复律器)心电图20和SICD消隐周期22。在图2中，显示了两个R波感测事件，其后紧接着R波起搏事件以及随后另一个R波感测事件。要认识到图2中显示的LCP和SICD心电图16、20是程式化的并且不表示实际的患者数据。通过比较具体感测或起搏事件的消隐周期22与SICD心电图20，可以看出消隐周期22具有这样一种持续时间(标记为“x”)即该持续时间确保T波不会被SICD捡拾或者考虑后续心跳的R波。在一些实施例中，如所示，与起搏事件相关的消隐周期22可以具有不同的持续时间(标记为“y”)。
在一些实施例中，消隐周期可以不立即开始，而是可以在第二植入式设备14(图1)感测事件或者创建起搏事件之后延迟一个延迟时间周期。在一些实施例中，该延迟允许SICD正确地感测以及分类心跳的R波并且仍然将T波放置在消隐周期中。这在图3中示出了，图3包括LCP心电图16、LCP R波感测事件18、SICD心电图20和SICD消隐周期24。在图3中，显示了两个R波感测事件，其后紧接着R波起搏事件以及随后另一个R波感测事件。该消隐周期具有延迟(图3中标记为“z”)，其允许当前心跳的R波在消隐周期之外，并且因此该R波可以被SICD考虑。
在一些实施例中，消隐周期持续时间至少部分地基于由第一植入式设备12和第二植入式设备14中的一个或两个检测到的当前心率来设置。例如，随着心率增加，消隐周期的持续时间可以减小。说明性消隐周期持续时间的实例包括在心率为60跳每分钟(bmp)下的大约90到大约110毫秒(mS)或者大约95到大约105mS，以及在心率为120bmp下的大约70到90mS或者大约75到大约85mS。在一些实施例中，说明性消隐周期持续时间可以是在心率为60跳每分钟(bmp)下的大约100毫秒(mS)或者在心率为120bmp下的大约80mS。
消隐周期持续时间可以至少部分地取决于检测到的心跳是内在心跳还是起搏心跳来设置。在一些实施例中，在从第二植入式设备14接收到检测到的第一心跳的指示之后，第一植入式设备12可以对于在开始消隐周期之前的消隐时间延迟，继续尝试从所述第一位置检测患者的第一心跳。消隐时间延迟可以在100到300mS范围内。在一些情况中，消隐时间延迟可以取决于患者的当前心率。例如，随着心率增加，消隐周期之前的延迟可以减小。
图4是植入式医疗设备26的示意性说明，植入式医疗设备26包括用于检测患者的心跳的一个或多个(示出了两个)电极28，以及用于经由传导通信从另一个医疗设备接收检测到的心跳的指示(例如R波检测标记)的接收器30。虽然说明性实施方式显示了使用相同的电极28来检测心跳和通信，但是设想可以设置分离的电极来检测心跳和通信。在任意情况下，植入式医疗设备26可以被配置为使得响应于经由电极28接收到检测到的心跳的指示，可以开始具有消隐周期持续时间的消隐周期，在该消隐周期期间植入式医疗设备26经由一个或多个电极28来消隐或者不识别患者的后续心跳。
在一些实施例中，至少部分地基于患者的当前心率和/或基于检测到的心跳是否是内在心跳还是起搏系统来设置消隐周期持续时间。接收到的检测到的心跳的指示在一些情况中可以包括R波检测标记。在一些实施例中，植入式医疗设备26可以是皮下植入式复律器，并且因此可以是第一植入式设备12(图1)的实例，而另一个医疗设备可以是无引线心脏起搏器并且因此是第二植入式设备14的实例。
图5描述了示例性无引线心脏起搏器(LCP)，其可以植入患者中并且可以操作以传递适当疗法到心脏，例如传递抗心动过速起搏(ATP)疗法、心脏再同步疗法(CRT)、心动过缓疗法等等。如图5中可见，LCP 100可以是使全部组件容纳在LCP 100中或者直接在壳体120上的紧凑型设备。在图5中所示实例中，LCP 100可以包括通信模块102、脉冲生成器模块104、电感测模块106、机械感测模块108、处理模块110、电池112和电极114。LCP 100可以取决于应用，包括更多或更少的模块。
通信模块102可以被配置为与位于LCP 100外部的设备如传感器、其他医疗设备如SICD等等通信。该设备可以位于患者身体外部或内部。不管位置如何，外部设备(即LCP 100的外部但是无需在患者身体外部)可以经由通信模块102与LCP 100通信，以完成一个或多个希望的功能。例如LCP 100可以通过通信模块102发送信息如感测到的电信号、数据、指令、消息、R波检测标记等等到外部医疗设备。外部医疗设备可以使用所发送的电信号、数据、指令、消息、R波检测标记等等来执行各种功能如确定心律不齐的发生、传递电刺激疗法、存储接收到的数据和/或执行任何其他合适的功能。LCP 100可以另外通过通信模块102从外部医疗设备接收信息如信号、数据指令和/或消息，并且LCP 100可以使用接收到信号、数据、指令和/或消息执行各种功能如确定心律不齐的发生，传递电刺激疗法，存储接收到的数据和/或执行任何其他合适的功能。通信模块102可以被配置为使用一个或多个用于与外部设备通信的方法。通信模块102可以例如经由射频(RF)信号、电感耦合、光信号、声音信号、传导的通信信号或任何其他适合通信的信号来通信。
在图5所示的实例中，脉冲生成器模块104可以电连接到电极114。在一些实例中，LCP 100可以另外包括电极114’。在该实例中，脉冲生成器模块104可以另外电连接到电极114’。脉冲生成器模块104可以被配置为生成电刺激信号。脉冲生成器模块104可以例如通过使用存储在LCP 100中的电池112中的能量生成电刺激信号，并且经由电极114和/或114’传递生成的电刺激信号。可替换地或另外地，脉冲生成器104可以包括一个或多个电容器，以及脉冲生成器104可以通过从电池112汲取能量来对一个或多个电容器充电。脉冲生成器104然后可以使用一个或多个电容器的能量来经由电极114和/或114’传递生成的电刺激信号。在至少一些实例中，LCP 100的脉冲生成器104可以包括开关电路以将电极114和/或114’中的一个或多个选择性地连接到脉冲生成器104以便选择脉冲生成器104经由电极114/114’(和/或其他电极)中的哪个传递电刺激疗法。脉冲生成器模块104可以生成具有具体特征或按具体次序的电刺激信号，以便提供多个不同刺激治疗中的一个或多个。脉冲生成器104可以例如被配置为生成电刺激信号以提供电刺激疗法来抗心动过缓、心动过速、心脏同步、心动过缓心律不齐、心动过速心律不齐、室颤心律不齐、心脏同步心律不齐和/或产生任意其他合适的电刺激疗法。一些更普通的电刺激疗法包括抗心动过速起搏(ATP)疗法、心脏再同步疗法(CRT)、心律转复/除颤疗法。
在一些实例中，LCP 100可以不包括脉冲生成器104。例如，LCP 100可以是仅诊断用设备。在该实例中，LCP 100可以不传递电刺激疗法到患者。相反，LCP 100可以采集与心电活动有关的数据和/或患者的生理参数并且经由通信模块102发送这种数据和/或确定到一个或多个其他医疗设备。
在一些实例中，LCP 100可以包括电感测模块106并且在一些情况中的机械感测模块108。电感测模块106可以被配置为感测心脏的心电活动。电感测模块106可以例如连接到电极114/114’，并且电感测模块106可以被配置为接收通过电极114/114’传导的心电信号。心电信号可以表示来自LCP 100所植入的腔室的局部信息。例如，如果LCP 100植入在心脏的心室中，则由LCP 100通过电极114/114’感测的心电信号可以表示心室的心电信号。机械感测模块108可以包括一个或多个传感器如加速计、血压传感器、心音传感器、血氧传感器、流量传感器和/或被配置为测量患者的一个或多个机械/化学参数的任何其他合适的传感器。电感测模块106和机械感测模块108可以连接到处理模块110，其可以提供用于表示感测到的机械参数的信号。虽然关于图5被描述为独立的感测模块，但是在一些情况中，电感测模块206和机械感测模块208可以根据期望而被组合成单个感测模块。
电极114/114’可以相对于壳体120固定但是暴露于LCP 100周围的组织和/或血液。在一些情况中，电极114可以整体设置在LCP 100的任意末端并且可以与模块102、104、106、108和110中的一个或多个电通信。电极114/114’可以由壳体120支撑，但是在一些情况中，电极114/114’可以仅通过短连接线连接到壳体120，使得电极114/114’不直接相对于壳体120固定。在LCP 100包括一个或多个电极114’的实例中，电极114’可以在一些情况中被设置在LCP 100的侧面上，其可以增加可被LCP 100用于感测心电活动、传递电刺激和/或与外部医疗设备通信的电极的数量。电极114/114’可以由一个或多个生物兼容导电材料如已知可安全植入人体中的各种金属或合金制造成。在一些实例中，连接到LCP 100的电极114/114’可以具有将电极114/114’与相邻电极、壳体120和/或LCP的其他部分电绝缘的绝缘部分。
处理模块110可以被配置为控制LCP 100的操作。处理模块110可以例如被配置为从电感测模块106和/或机械感测模块108接收电信号。基于接收到的信号，处理模块110可以例如确定心律不齐的发生以及在一些情况中确定心律不齐的类型。基于任意确定的心律不齐，处理模块110可以控制脉冲生成器模块104根据一个或多个治疗生成电信号以治疗所确定的心律不齐。处理模块110可以进一步从通信模块102接收信息。在一些实例中，处理模块110可以使用这种接收到的信息来助于确定是否发生了心律不齐，确定心律不齐的类型和/或响应于该信息采取具体动作。处理模块110可以另外控制通信模块102发送/接收信息到/自其他设备。
在一些实例中，处理模块110可以包括预编程的芯片如超大规模集成(VLSI)芯片或者专用集成电路(ASIC)。在该实施方式中，芯片可以被预编程有控制逻辑以控制LCP 100的操作。通过使用预编程的芯片，处理模块110可以使用比其他可编程电路(例如通用可编程微处理器)更少的电力同时仍然能够维持基本功能，从而潜在增加LCP 100的电池寿命。在其他实例中，处理模块110可以包括可编程微处理器。该可编程微处理器即使在植入之后也可以允许用户调整LCP 100的控制逻辑，因而与当使用预编程ASIC时相比允许LCP 100的更大的灵活性。在一些实例中，处理模块110可以进一步包括存储器，并且处理模块110可以将信息存储在存储器上以及从存储器读取信息。在其他实例中，LCP 100可以包括与处理模块110通信的独立的存储器(未显示)，使得处理模块110可以从独立的存储器读取信息以及向独立的存储器写入信息。
电池112可以提供电力给LCP 100用于其操作。在一些实例中，电池112可以是不可再充电的基于锂的电池。在其他实例中，不可再充电电池可以根据期望而由其他合适材料制造。由于LCP 100是植入式设备，所以在植入之后，对LCP 100的接近可能被限制。因此，希望具有足够的电池容量以在治疗周期如数天、数周、数月、数年或甚至数十年期间传递治疗。在其他实例中，电池110可以是可再充电电池，其可以助于增加LCP 100的可使用寿命。在其他实例中，根据期望，电池110可以是一些其它类型的电源。
为了将LCP 100植入患者身体内，操作员(例如医师、临床医生等等)可以将LCP100固定到患者心脏的心脏组织。为了助于固定，LCP 100可以包括一个或多个锚116。锚116可以包括多个固定或锚定机构中的任意一个。锚116可以包括一个或多个管脚、钉、螺纹、螺钉、螺旋、尖齿等等。在一些实例中，虽然未显示，但是锚116可以包括位于其可以沿锚116的至少部分长度延伸的外表面的螺纹。螺纹可以提供心脏组织与锚之间的摩擦，以助于将锚116固定在心脏组织中。在其他实例中，锚116可以包括其他结构如倒钩、长钉等等以助于与周围心脏组织的接合。
图6描述了另一个医疗设备(MD)200的实例，其可以结合LCP 100(图5)来使用以便检测以及治疗心律失常和其他心脏条件。在所示实例中，MD 200可以包括通信模块202、脉冲生成器模块204、电感测模块206、机械感测模块208、处理模块210和电池218。这些模块中的每一个可以类似于LCP 100的模块102、104、106、108和110。另外，电池218可以类似于LCP100的电池112。然而在一些实例中，MD 200可以在壳体220中具有更大的体积。在该实例中，MD 200可以包括更大的电池和/或能够比LCP 100的处理模块110处理更复杂的操作的更大的处理模块210。
虽然设想MD 200可以是如图5中所示的另一个无引线设备，但是在一些实例中，MD200可以包括引线如引线212。引线212可以包括在位于壳体220中的一个或多个模块和电极214之间传导电信号的电线。在一些情况中，引线212可以连接到并且延伸出MD 200的壳体220。在一些实例中，引线212植入在患者心脏上、内或附近。引线212可以包括位于引线212上的各种位置处并且在一些情况中距壳体220各种距离的一个或多个电极214。一些引线212可以仅包括单个电极214，而其他引线212可以包括多个电极214。通常，电极214位于引线212上，使得当引线212植入患者中时，电极214中的一个或多个被定位为执行希望的功能。在一些情况中，一个或多个引线214可以与患者的心脏组织接触。在一些情况中，一个或多个电极214可以定位在皮下但是相邻患者心脏。在一些情况中，引线214可以传导内在生成的电信号，例如用于表示内在的心电活动的信号，到引线212。引线212因而可以传导接收到的电信号到MD 200的模块202、204、206和208中的一个或多个。在一些情况中，MD 200可以生成电刺激信号，并且引线212可以传导生成的电刺激信号到电极214。电极214然后可以传导电信号且传递信号到患者的心脏(直接地或间接地)。
如同机械感测模块108，机械感测模块208可以包括或者电连接到一个或多个传感器如加速计、血压传感器、心音传感器、血氧传感器和/或被配置为测量心脏和/或患者的一个或多个机械/化学参数的其他传感器。在一些实例中，这些传感器中的一个或多个可以位于引线212上，但这不是必须的。在一些实例中，一个或多个传感器可以位于壳体220上。
虽然不需要，但是在一些实例中，MD 200可以是植入式设备。在该实例中，MD 200的壳体220可以例如植入到患者的经胸区域。壳体220通常可以包括任意数量的已知材料，该材料可安全植入人体并且当植入时将MD 200的各种组件与患者身体的流体和组织隔绝密封。
在一些情况中，MD 200可以是植入式心脏起搏器(ICP)。在该实例中，MD 200可以具有一个或多个引线例如引线212，其可以植入在患者心脏上或中。一个或多个引线212可以包括与患者心脏的心脏组织和/或血液接触的一个或多个电极214。MD 200可以被配置为感测内在生成的心电信号以及例如基于感测到的信号的分析来确定一个或多个心律失常。MD 200可以被配置为经由植入心脏中的引线212传递CRT、ATP治疗、心动过缓治疗和/或其他治疗类型。在一些实例中，MD 200可以另外被配置为提供除颤治疗。
在一些实例中，MD 200可以是植入式心律转复除颤器(ICD)。在该实例中，MD 200可以包括植入患者心脏中的一个或多个引线。MD 200也可以被配置为感测心电信号、基于感测到的信号确定快速性心律失常的发生，以及可以被配置为响应于确定快速性心律失常的发生而传递除颤治疗。在其他实例中，MD 200可以是皮下植入式心律转复除颤器(S-ICD)。在MD 200是S-ICD的实例中，引线212中的一个可以是皮下植入的引线。在MD 200是S-ICD的至少一些实例中，MD 200可以仅包括单个皮下植入的引线，但是这不是必须的。在一些实例中，引线可以具有放置在皮下并且在胸腔外部的一个或多个电极。在其他实例中，引线可以具有放置在胸腔内部的一个或多个电极。
在一些实例中，MD 200可以不是植入式医疗设备。相反，MD 200可以是患者身体外部的设备并且可以包括放置在患者身体上的皮肤电极。在该实例中MD 200可能能够感测表面电信号(例如由心脏生成的心电信号或由植入在患者身体中的设备生成并且通过身体传导到皮肤的电信号)。在该实例中，MD 200可以被配置为传递各种类型的电刺激疗法，包括例如除颤治疗。
在一个实例中，消隐可以被定义为医疗设备100或/和医疗设备200在消隐周期内分别忽略来自电感测模块106和/或电感测模块206的全部信息。在另一个实例中，消隐包括在消隐周期期间分别断开一个或多个电极114/114’和/或电极214与电感测模块106和/或电感测模块206的连接。在另一个实例中，消隐包括在消隐周期期间从电感测模块106和/或电感测模块206去除电力。在另一个实例中，消隐包括在消隐周期期间将一个或多个电极114/114’和/或电极214连接到电信号接地。在进一步的实例中，消隐包括在消隐周期期间进行上述实例中的一个或多个的组合。
图7示出了医疗设备系统和可被多个医疗设备302、304、306和/或310用于通信的通信路径的实例。在所示实例中，医疗设备系统300可以包括LCP 302和304、外部医疗设备306和其他传感器/设备310。外部设备306可以是前文关于MD 200所述的任意设备。其它传感器/设备310也可以为前文关于MD 200所述的任意设备。在一些实例中，其他传感器/设备310可以包括传感器如加速计或血压传感器等等。在一些实例中，其他传感器/设备310可以包括可用于编程系统300的一个或多个设备的外部编程器设备。
系统300的各种设备可以经由通信路径308通信。例如，LCP 302和/或304可以感测内在心电信号并且可以经由通信路径308发送该信号到系统300的一个或多个其他设备302/304、306和310。在一个实例中，一个或多个设备302/304可以接收该信号，并且基于接收到的信号确定心律不齐的发生。在一些情况中，设备302/304可以发送该确定到系统300的一个或多个其他设备306和310。在一些情况中，系统300的一个或多个其他设备302/304、306和310可以基于发送的心律不齐的确定来采取行动，如通过传递合适的电刺激到患者心脏。设想通信路径308可以使用RF信号、感性耦合、光信号、声信号或适用于通信的任意其他信号来通信。另外，在至少一些实例中，设备通信路径308可以包括多个信号类型。例如，其他传感器/设备310可以使用第一信号类型(例如RF通信)与外部设备306通信，而使用第二信号类型(例如传导通信)与LCP 302/304通信。此外，在一些实例中，设备之间的通信可能受限。例如，如上所述，在一些实例中，LCP 302/304仅可以通过其他传感器/设备310与外部设备306通信，其中，LCP 302/304发送信号到其他传感器/设备310，并且其他传感器/设备310中继接收到的信号到外部设备306。
在一些情况中，通信路径308可以包括传导通信。因此，系统300的设备可以具有允许该传导通信的组件。系统300的设备可以例如被配置为经由发射设备的一个或多个电极发射传导通信信号(例如电流和/或电压脉冲)到患者身体中，并且可以经由接收设备的一个或多个电极接收传导通信信号(例如脉冲)。患者身体可以将传导通信信号(例如脉冲)从发射设备的一个或多个电极“传导”到系统300中的接收设备的电极。在该实例中，传递的传导通信信号(例如脉冲)可以与起搏或其他治疗信号不同。系统300的设备可以例如以对于心脏亚阈值的幅度/脉冲宽度传递电通信脉冲。在一些情况中，虽然传递的电通信脉冲的幅度/脉冲宽度可以高于心脏的获取阈值，但是可以在心脏的消隐周期期间传递以及/或者如果希望则可以合并到起搏脉冲中或调制到起搏脉冲上。
可以用任意合适的方式调制传递的电通信脉冲，以编码所发送的信息。在一些情况中，通信脉冲可以被脉宽调制或脉幅调制。可替换地或者另外地，可以调制脉冲之间的时间以编码希望的信息。在一些情况中，传导通信脉冲可以是电压脉冲、电流脉冲、两相电压脉冲、两相电流脉冲或者所希望的任意其他合适的电脉冲。
图8和图9显示了可被配置为根据本文所述的技术来操作的说明性医疗设备系统。在图8中，LCP 402被显示为固定到心脏410的左心室的内部，以及脉冲生成器406被显示为耦接到具有一个或多个电极408a-408c的引线412。在一些情况中，脉冲生成器406可以是皮下植入式心律转复除颤器(S-ICD)的一部分，并且一个或多个电极408a-408c可以定位为皮下邻近心脏。在一些情况中，LCP 402可以与皮下植入式心律转复除颤器(S-ICD)通信。在一些情况中，LCP 302可以根据希望位于心脏的右心室、右心房或左心房中。在一些情况中，可以植入多个LCP 302。例如，一个LCP可以植入在右心室中并且另一个可以植入在右心房中。在另一个实例中，一个LCP可以植入在右心室中并且另一个可以植入在左心室中。在另一个实例中，一个LCP可以植入在心脏的每个腔室中。
在图9中，LCP 502被显示为固定到心脏510的左心室的内部，并且脉冲生成器506被显示为耦接到具有一个或多个电极504a-504c的引线512。在一些情况中，脉冲生成器506可以是植入式心脏起搏器(ICP)和/或植入式心律转复除颤器(ICD)的一部分，并且一个或多个电极504a-504c可以定位在心脏510中。在一些情况中，LCP 502可以与植入式心脏起搏器(ICP)和/或植入式心律转复除颤器(ICD)通信。
医疗设备系统400和500还可以包括外部支持设备如外部支持设备420和520。外部支持设备420和520可用于执行功能如设备识别、设备编程和/或使用本文所述一个或多个通信技术在设备之间传递实时和/或存储的数据。作为一个实例，外部支持设备420与脉冲生成器406之间的通信可以经由无线模式执行，并且脉冲生成器406与LCP 402之间的通信可以经由传导模式执行。在一些实例中，LCP 402与外部支持设备420之间的通信通过经过脉冲生成器406发送通信信息来完成。然而，在其他实例中，LCP 402与外部支持设备420之间的通信可以是经由通信模块的。
图8至图9仅示出了可被配置为根据本文所公开的技术来操作的医疗设备系统的两个实例。其他示例性医疗设备系统可以包括附加的或不同的医疗设备和/或配置。例如，适用于根据本文所公开的技术来操作的其他医疗设备系统可以包括植入在心脏中或上的附加的LCP。另一个示例性医疗设备系统可以包括多个LCP而没有其他设备如脉冲生成器406或506，其中至少一个LCP能够传递除颤疗法。在其他实例中，医疗设备、引线和/或电极的配置或放置可以与图8和9中所述那些不同。因此，应该认识到可以根据本文所公开的技术来操作与图8和图9中描述的那些医疗设备系统不同的大量其他医疗设备系统。就这点而言，图8和图9中显示的实例不应被视为以任意方式进行限制。
图10示出了可以使用植入式心律管理系统10(图1)执行的方法的流程图。在该实例中，第一植入式设备12可以是皮下植入式复律器而第二植入式设备14可以是无引线心脏起搏器。该方法涉及使用来自无引线心脏起搏器的数据改善皮下植入式复律器的性能。可以经由无引线心脏起搏器检测第一心跳，如方框1010整体所指示。如方框1020整体所指示，也可以经由皮下植入式复律器检测第一心跳。由无引线心脏起搏器检测到的第一心跳的指示可以发送到皮下植入式复律器，如方框1030整体所指示。如方框1040整体所指示，可以由皮下植入式复律器开始消隐周期使得检测到的第一心跳的T波被皮下植入式复律器消隐以便不被解释为后续第二心跳。在一些实施例中，消隐周期被配置为使得后续心跳会被皮下植入式复律器看见。这可以助于防止皮下植入式复律器将第一心跳的T波视为后续心跳的R波。如果皮下植入式复律器将第一心跳的T波视为后续心跳的R波，则皮下植入式复律器将有效地翻倍计数心跳，这会影响传递的疗法。
在一些情况中，第二植入式设备14可以仅有条件地发生检测到的心跳的指示到第一植入式设备12。例如，第二植入式设备14仅可以在特定预定条件下如在其猜测第一植入式设备12在和/或将翻倍计数心跳之后，发送检测到的心跳的指示到第一植入式设备12。例如在一些情况中，在第一植入式设备12确定其可能翻倍计数心跳之后，第一植入式设备12可以发送指令到第二植入式设备14以开始发送检测到的心跳的指示。在第一植入式设备12确定它不在翻倍计数心跳之后，第一植入式设备12然后可以发送指令到第二植入式设备14以停止发送检测到的心跳的指示。在另一个实例中，当第一植入式设备12确定其期望传递休克疗法以验证第一植入式设备12是否翻倍计数心跳时，第一植入式设备12可以发送指令到第二植入式设备14以开始发送检测到的心跳的指示。在实际传递休克疗法之前，第一植入式设备12然后可以发送指令到第二植入式设备14以停止发送检测到的心跳的指示。这些仅仅是一些实例。在一些实例中，在大多数情况下，第二植入式设备14可以不发送检测到的心跳的指示到第一植入式设备12，这可以助于延长第二植入式设备14的电池寿命并且降低身体内的通信流量。
本领域熟练技术人员将认识到本公开可以表达成除了本文描述和设想的具体实例之外的各种形式。例如，如本文所描述的，各种实例包括描述为执行各种功能的一个或多个模块。然而，其他实例可以包括将所描述的功能分割成比本文说描述的模块更多的模块的附加模块。另外，其他实例可以将所描述的功能合并到更少模块中。因此，在不脱离如所附权利要求所述的本公开的范围和精神的前提下，可以做出形式和细节的偏离。

Claims (15)

1.一种植入式心律系统包括：
第一植入式医疗设备，其被配置为监视患者的心律并且提供休克疗法以纠正患者的心律，所述第一植入式医疗设备还被配置为从第一位置检测患者的第一心跳；
第二植入式医疗设备，其被配置为感测患者的心脏，所述第二植入式医疗设备被配置为从第二位置检测患者的第一心跳；以及
其中，所述第二植入式医疗设备在检测所述第一心跳之后，发送所检测到的第一心跳的指示到所述第一植入式医疗设备，并且作为响应，所述第一植入式医疗设备开始具有消隐周期持续时间的消隐周期使得所述检测到的第一心跳的T波被所述第一植入式医疗设备消隐以便不被解释为后续第二心跳。
2.根据权利要求1所述的植入式心律系统，其中，所述第一植入式医疗设备包括除颤器或复律器，并且可选择地包括皮下复律器，以及所述第二植入式医疗设备可选择地包括无引线心脏起搏器。
3.根据权利要求1或2中的任意一个所述的植入式心律系统，其中，所述第二植入式医疗设备经由传导通信与所述第一植入式医疗设备通信。
4.根据权利要求1到3中的任意一个所述的植入式心律系统，其中，发送的所述检测到的第一心跳的指示包括R波检测标记。
5.根据权利要求1到4中的任意一个所述的植入式心律系统，其中，至少部分地基于由所述第一植入式医疗设备和所述第二植入式医疗设备中的一个或两个检测到的当前心率，以及可选择地基于所述检测到的第一心跳是内在心跳还是起搏心跳，设置所述消隐周期持续时间。
6.根据权利要求1到5中的任意一个所述的植入式心律系统，其中，在从所述第二植入式医疗设备接收到所述检测到的第一心跳的指示之后，所述第一植入式医疗设备对于在开始所述消隐周期之前的消隐时间延迟，继续尝试从所述第一位置检测所述患者的第一心跳。
7.根据权利要求1到6中的任意一个所述的植入式心律系统，其中，所述消隐时间延迟取决于所述患者的当前心率。
8.根据权利要求1到7中的任意一个所述的植入式心律系统，其中，所述第一位置在患者心脏外以及可选择地在患者胸腔外，以及所述第二位置在患者心脏内以及可选择地在患者心脏的腔室内。
9.一种植入式医疗设备，包括：
一个或多个电极，用于检测患者的心跳；
接收器，用于经由传导通信从另一个医疗设备接收检测到的心跳的指示；以及
响应于接收到所述检测到的心跳的指示，开始具有消隐周期持续时间的消隐周期，其中，所述植入式医疗设备被配置为在所述消隐周期持续时间期间经由所述植入式医疗设备的所述一个或多个电极不识别所述患者的后续心跳。
10.根据权利要求9所述的植入式医疗设备，其中，响应于接收到检测到的心跳的指示，所述植入式医疗设备对于在开始所述消隐周期之前的消隐时间延迟，继续感测所述患者的心跳。
11.根据权利要求9到10中的任意一个所述的植入式医疗设备，其中，至少部分地基于患者的当前心率和/或基于所述检测到的心跳是内在心跳还是起搏心跳，设置所述消隐周期持续时间。
12.根据权利要求9到11中的任意一个所述的植入式医疗设备，其中，所述植入式医疗设备是皮下植入式复律器，并且所述另一个医疗设备是无引线心脏起搏器。
13.根据权利要求9到12中的任意一个所述的植入式医疗设备，其中，接收到的所述检测到的心跳的指示包括R波检测标记。
14.一种使用来自无引线心脏起搏器的数据来改善皮下植入式复律器的性能的方法，所述方法包括：
经由所述无引线心脏起搏器检测第一心跳；
经由所述皮下植入式复律器检测所述第一心跳；
发送由所述无引线心脏起搏器检测到的第一心跳的指示到所述皮下植入式复律器；以及
由所述皮下植入式复律器开始消隐周期使得所述检测到的第一心跳的T波被所述皮下植入式复律器消隐从而不被解释为后续第二心跳。
15.根据权利要求14所述的方法，其中，所述消隐周期被配置为使得后续心跳将由所述皮下植入式复律器看到。
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