CN107206240A - 用于治疗心律不齐的系统和方法 - Google Patents

用于治疗心律不齐的系统和方法 Download PDF

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CN107206240A
CN107206240A CN201680008149.1A CN201680008149A CN107206240A CN 107206240 A CN107206240 A CN 107206240A CN 201680008149 A CN201680008149 A CN 201680008149A CN 107206240 A CN107206240 A CN 107206240A
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cardiac arrhythmia
lcp
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CN107206240B (zh
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布兰登·E·库普
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Cardiac Pacemakers 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A61B5/29—Invasive for permanent or long-term implantation
    • A—HUMAN NECESSITIES
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    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
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    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
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    • A61B5/363—Detecting tachycardia or bradycardia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
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    • A61N1/3621—Heart stimulators for treating or preventing abnormally high heart rate
    • A61N1/3624—Heart stimulators for treating or preventing abnormally high heart rate occurring in the atrium, i.e. atrial tachycardia
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    • A61N1/372—Arrangements in connection with the implantation of stimulators
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    • 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
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    • 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
    • A—HUMAN NECESSITIES
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    • 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
    • A61N1/3987—Heart defibrillators characterised by the timing or triggering of the shock
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile

Abstract

公开了用于治疗心律不齐的系统和方法。在一个实施例中，SICD包括两个或更多个电极、电荷存储设备和可操作地耦接到两个或更多个电极和电荷存储设备的控制器。在一些实施例中，控制器配置为：监视患者的心脏的心脏活动；基于心脏活动，检测心律不齐的发生；从两个或更多个类型的心律不齐，确定检测到的心律不齐的类型。如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则控制器发送指令给LCP接收以由LCP开始应用ATP疗法。如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则控制器不发送指令。

Description

用于治疗心律不齐的系统和方法
相关申请的交叉引用
本申请要求2015年2月6日递交的美国临时专利申请序列号62/113,173的权益，通过引用的方式将其公开并入本文。
技术领域
本公开整体涉及用于治疗心律不齐的系统、设备和方法，并且更具体地涉及用于检测心律不齐以及在多个设备之间协调疗法的系统、设备和方法。
背景技术
起搏仪器可用于治疗这样一种患者即该患者遭受导致心脏向患者身体传递足够数量的血液的能力降低的各种心脏状况。这些心脏状况可能导致快速的、不规律的和/或不充分的心脏收缩。为了助于减轻这些状况中的一些，已在患者身体中植入各种设备(例如起搏器、除颤器等等)。该设备可以监视和提供电刺激给患者以助于心脏以更加正常、充分和/或安全的方式操作。在一些情况中，患者可以具有多个植入的设备。
发明内容
本公开整体涉及用于治疗心律不齐的系统、设备和方法，并且更具体地涉及用于检测心律不齐以及在无引线心脏起搏器和另一个医疗设备之间协调抗心动过速起搏(ATP)疗法和除颤电击疗法的系统、设备和方法。
在一个实施例中，一种用于传递除颤电击到患者的心脏的皮下植入式心律转复除颤器(SICD)包括：两个或更多个电极；电荷存储设备，用于存储能够被传递以经由两个或更多个电极来电击心脏的电荷；以及控制器，可操作地耦接到两个或更多个电极和电荷存储设备。控制器可以配置为：经由经两个或更多个电极接收到的心脏信号监视患者的心脏的心脏活动；基于心脏活动，检测心律不齐的发生；以及从两个或更多个类型的心律不齐，确定检测到的心律不齐的类型。如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则控制器可以经由两个或更多个电极发送指令给无引线心脏起搏器(LCP)接收以由LCP开始应用ATP疗法。如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则控制器可以不发送指令。
另外或可替换地，在前述实施例中，指令还可以包括用于定义ATP疗法的一个或多个特征的一个或多个ATP参数。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括ATP的方法。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括在ATP疗法期间应用的多个ATP突发。
另外或可替换地，在任意一个前述实施例中，控制器可以进一步配置为：如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则开始电荷存储设备的充电；以及如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则等待开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则不开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则终止电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，第一心律不齐类型集合可以包括单形性室性心动过速(MVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括多形性室性心动过速(PVT)、室上性心动过速(SVT)和心室颤动(VF)中的一个或多个。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括多形性室性心动过速(PVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括室上性心动过速(SVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括单形性室性心动过速(MVT)。
另外或可替换地，在任意一个前述实施例中，第一心律不齐类型集合和第二心律不齐类型集合可以共享一个或多个公共心律不齐类型，但这不是必须的。
另外或可替换地，在任意一个前述实施例中，第一心律不齐类型集合中的心律不齐类型可以是用户可选择的。
另外或可替换地，在任意一个前述实施例中，SICD可以进一步包括能量存储模块，其中，第一心律不齐类型集合中的心律不齐类型至少部分地取决于能量存储模块的电荷等级。
另外或可替换地，在任意一个前述实施例中，为了从两个或更多个类型的心律不齐确定检测到的心律不齐的类型，控制器可以配置为将心脏信号与一个或多个模板比较。
在另一个实施例中，一种用于传递除颤电击到患者的心脏的皮下植入式心律转复除颤器(SICD)可以包括：两个或更多个电极；电荷存储设备，用于存储可被传递以经由两个或更多个电极来电击心脏的电荷；以及控制器，可操作地耦接到两个或更多个电极和电荷存储设备。控制器可以配置为：经由经两个或更多个电极接收到的心脏信号监视患者的心脏的心脏活动；基于心脏活动，检测心律不齐的发生；以及从两个或更多个类型的心律不齐，确定检测到的心律不齐的类型。如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则控制器可以经由两个或更多个电极发送指令给无引线心脏起搏器(LCP)接收以由LCP开始应用ATP疗法。如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则控制器可以不发送指令。
另外或可替换地，在前述实施例中，指令还可以包括用于定义ATP疗法的一个或多个特征的一个或多个ATP参数。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括ATP的方法。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括在ATP疗法期间应用的多个ATP突发。
另外或可替换地，在任意一个前述实施例中，控制器可以进一步配置为：如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则开始电荷存储设备的充电；以及如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则等待开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则不开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则终止电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，第一心律不齐类型集合可以包括单形性室性心动过速(MVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括多形性室性心动过速(PVT)、室上性心动过速(SVT)和心室颤动(VF)中的一个或多个。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括多形性室性心动过速(PVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括室上性心动过速(SVT)。
另外或可替换地，在任意一个前述实施例中，第二心律不齐类型集合可以包括单形性室性心动过速(MVT)。
另外或可替换地，在任意一个前述实施例中，第一心律不齐类型集合和第二心律不齐类型集合可以共享一个或多个公共心律不齐类型，但这不是必须的。
在另一个实施例中，一种用于传递除颤电击到患者的心脏的植入式心律转复除颤器(ICD)可以包括：电荷存储设备，用于存储可被传递以电击心脏的电荷；以及控制器，可操作地耦接到电荷存储设备。控制器可以配置为：监视患者的心脏的心脏活动；基于心脏活动，检测心律不齐的发生；以及从两个或更多个类型的心律不齐，确定检测到的心律不齐的类型。如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则控制器可以配置为发送指令给无引线心脏起搏器(LCP)接收以由LCP开始应用ATP疗法。如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则控制器可以不发送指令。
另外或可替换地，在前述实施例中，指令还可以包括用于定义ATP疗法的一个或多个特征的一个或多个ATP参数。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括ATP的方法。
另外或可替换地，在任意一个前述实施例中，ATP疗法的一个或多个特征可以包括在ATP疗法期间应用的多个ATP突发。
另外或可替换地，在任意一个前述实施例中，控制器可以进一步配置为：如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则开始电荷存储设备的充电；以及如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则等待开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则不开始电荷存储设备的充电。
另外或可替换地，在任意一个前述实施例中，如果发送指令以由LCP开始应用ATP疗法，则控制器可以进一步配置为确定由LCP进行的ATP疗法的应用是否成功地终止心律不齐，以及如果是，则如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则终止电荷存储设备的充电。
在另一个实施例中，一种由植入式心律转复除颤器(ICD)实现的方法可以包括：确定心律不齐的发生以及从两个或更多个类型的心律不齐确定检测到的心律不齐的类型。该方法可以进一步包括如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则发送指令给无引线心脏起搏器(LCP)接收以由LCP开始应用ATP疗法。如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则不发送指令。
另外或可替换地，在前述实施例中，该方法可以进一步包括如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则开始电荷存储设备的充电；以及如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则等待电荷存储设备的充电。
以上摘要不是意图描述本公开的每个实施例或者每个实现。通过结合附图参考以下描述和权利要求，本公开的优点、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
通过结合附图考虑各种示例性实施例的以下描述，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施例的说明性无引线心脏起搏器(LCP)的示意性方框图；
图2是可以结合图1的LCP使用的另一个说明性医疗设备的示意性方框图；
图3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4是根据本公开的另一个实施例的包括LCP和另一个医疗设备的系统的示意图；
图5是根据本公开的另一个实施例的包括无引线心脏起搏器(LCP)和另一个医疗设备的系统的示意图；
图6是可以由医疗设备或医疗设备系统如关于图1-图5所述的医疗设备和医疗设备系统所实现的说明性方法的流程图；
图7是可以由医疗设备或医疗设备系统如关于图1-图5所述的医疗设备和医疗设备系统所实现的说明性方法的流程图；以及
图8是可以由医疗设备或医疗设备系统如关于图1-图5所述的医疗设备和医疗设备系统所实现的说明性方法的流程图。
虽然本公开可修改成多种修改和替换形式，但是已在附图中通过实施例的方式显示了并且将详细地描述其细节。但是应该理解，其意图不是为了将本公开的方面限于所述具体说明性实施例。相反，意图覆盖落入本公开精神和范围中的全部修改、等效物和替换物。
具体实施方式
应该参考附图来阅读以下描述，在不同的附图中相似的元件标号相同。无需按比例描绘的说明书和附图描述了说明性实施例并且不意图限制本公开的范围。
本公开描述了用于检测和治疗心律不齐的系统、设备和方法，并且更具体地描述了对于不同类型的心律不齐实现不同的治疗协议的系统、设备和方法。一种用于治疗一类型的心律不齐即心动过速心律不齐的选择包括使用抗心动过速疗法(ATP)技术。这些技术的一些实施例包括以比心动过速更快的速率传递起搏脉冲到患者的心脏，以力图使得心脏追踪ATP脉冲，从而终止生理引起的心动过速。如果ATP疗法不起作用，则可以应用其他措施如传递除颤脉冲到心脏以试图终止心动过速。心动过速可以分类为多种不同类型的心动过速——包括单形性室性心动过速(MVT)、多形性室性心动过速(PVT)、室上性心动过速(SVT)和心室颤动(VF)。ATP疗法可能在终止这些心动过速中一些上比这些心动过速中的其他的更有效。例如，ATP可能对于终止MVT最有效(有可能80—90％终止)。效率可能对于PVT(例如20-40％终止)以及SVT和VF(例如10-20％终止)减小。此外，应用ATP疗法到仅仅特定特别匹配的心动过速心律不齐可以助于降低其他较不匹配的心动过速进入除颤/心律转复区域的加速度。因此，对下文将更完整地详述的不同类型的心动过速应用不同的疗法协议可能是有益的。
图1是可以植入在患者中以及可以操作以感测生理信号和参数以及传递一个或多个类型的电刺激疗法到患者的组织的示例性无引线心脏起搏器(LCP)的概念图。示例性电刺激疗法包括心律缓慢起搏、速率响应式起搏疗法、心脏再同步疗法(CRT)、抗心动过速起搏(ATP)疗法等等。如从图1中可以看出的，LCP 100可以是紧凑的设备，其中全部组件封装在LCP 100中或者直接在外壳120上。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、能量存储模块112和电极114。
如图1中所述，LCP 100可以包括电极114，其可以相对外壳120固定并且电气暴露于LCP 100周围的组织和/或血液。电极114可以整体向和从LCP 100和周围组织和/或血液传导电信号。该电信号可以包括例如通信脉冲、电刺激脉冲和内在心脏电信号。内在心电信号可以包括由心脏生成的电信号并且可以由心电图(ECG)表示。
电极114可以包括一个或多个生物兼容传导材料如已知可安全植入到患者身体中的各种金属或合金。在一些实例中，电极114可以整体设置在LCP 100的任意末端上并且可以与模块102、104、106、108和110中的一个或多个通信。在电极114直接固定在外壳120上的实施例中，绝缘材料可以将电极114与相邻电极、外壳120和/或LCP 100的其他部分电绝缘。在一些实例中，一些或全部电极114可以与外壳120间隔开并且通过连接线连接到外壳120和/或LCP 100的其他组件。在该实例中，电极114可以放置在从外壳120向外延伸的尾部(未显示)上。如图1中所示，在一些实施例中，LCP 100可以包括电极114’。电极114’可以增补电极114或者可以替换一个或多个电极114。电极114’可以与电极114类似，除了电极114’设置在LCP 100的侧面之外。在一些情况中，电极114’可以增加可被LCP 100用于传递通信脉冲和/或电刺激脉冲和/或可以感测内在心电信号、通信脉冲和/或电刺激脉冲的电极的数量。
电极114’和/或电极114可以采取多种尺寸和/或形状中的任意一个并且可以隔开多种间隔中的任意一个。例如电极114可以具有2到20毫米(mm)的外径。在其他实施例中，电极114’和/或电极114可以具有2、3、5、7毫米(mm)或任意其他合适的直径、尺度和/或形状。电极114’和/或电极114的示例性长度可以包括例如1、3、5、10毫米(mm)或任意其他合适长度。如本文所使用的，长度是电极114’和/或电极114从外壳120的外表面向外延伸的尺度。在一些实例中，电极114’和/或电极114中的至少一些可以彼此隔开20、30、40、50毫米(mm)的距离或者任意其他合适的间隔。单个设备的电极114’和/或电极114可以具有彼此不同的尺寸，以及设备上的电极的间隔和/或长度可以统一或不统一。
在所示实施例中，通信模块102可以电耦接到电极114’和/或电极114并且可以配置为传递通信脉冲到患者组织以便与其他设备如传感器、编程器、其他医疗设备等等通信。如本文使用的通信脉冲可以是用于通过自身或者通过与一个或多个其他已调信号相结合来向另一个设备传递信息的任意已调信号。在一些实施例中，通信模块可以限于亚阈信号，其不导致心脏的捕获但是仍然传递信息。通信脉冲可以传递到定位在患者身体外部或内部的另一个设备。通信模块102可以另外配置为感测由位于患者身体外部或内部的其他设备传递的通信脉冲。
通信模块102可以通信以助于实现一个或多个希望的功能。一些示例性功能包括使用通信的数据来传递感测到的数据以确定事件如心律不齐的发生、协调电刺激疗法的传递和/或其他功能。在一些情况中，LCP 100可以使用通信脉冲通信原始信息、已处理信息、消息和/或命令和/或其他数据。原始信息可以包括信息如感测到的电信号(例如感测到的ECG)、从耦接的传感器采集的信号等等。在一些实施例中，已处理信息可以包括使用一个或多个信号处理技术过滤的信号。已处理信息还可以包括由LCP 100和/或另一个设备确定的参数和/或事件如确定的心率、确定的心率的定时、另一个确定的事件的定时、阈值交叉的确定、监视的时间周期的到期、活动等级参数、血氧参数、血压参数、心声参数等等。消息和/或命令可以包括用于指示另一个设备采取行动的指令等等、发送设备的即将到来的动作的通知、从接收设备进行读取的请求，向接收设备写入数据的请求、信息消息和/或其他消息命令。
在至少一些实施例中，通信模块102(或LCP 100)可以进一步包括切换电路以选择性地连接电极114’和/或电极114中的一个或多个到通信模块102以便选择通信模块102向哪个电极114’和/或电极114传递通信脉冲。设想通信模块102可以经由传导信号、射频(RF)信号、光信号、声学信号、电感耦合和/或任意其他合适的通信方法与其他设备通信。
在所示实施例中，脉冲生成器模块104可以电连接到一个或多个电极114’和/或电极114。脉冲生成器模块104可以配置为生成电刺激脉冲并且经由一个或多个电极114’和/或电极114传递电刺激脉冲到患者组织以便实现一个或多个电刺激疗法。如本文使用的电刺激脉冲意味着包括可以传递到患者的组织以用于任意类型的疾病或异常的治疗的任意电信号。例如，当用于治疗心脏病时，脉冲生成器模块104可以生成用于捕获患者的心脏即导致心脏响应于传递的电刺激脉冲而收缩的电刺激起搏脉冲。在另一个实施例中，电刺激脉冲可以是用于电击心脏使不颤动的除颤/心律转复脉冲。在另一个实施例中，电刺激脉冲可以是抗心动过速(ATP)脉冲。这些仅仅是一些实例。当用于治疗其他疾病时，脉冲生成器模块104可以生成适用于神经刺激疗法等等的电刺激脉冲。脉冲生成器模块104可以包括一个或多个电容器元件和/或其他电荷存储设备以助于生成和传递合适的电刺激脉冲。在所示实施例中，脉冲生成器模块104可以使用存储在能量存储模块112中的能量生成电刺激脉冲。
脉冲生成器模块104可以包括例如通过调整电刺激脉冲的脉冲宽度和/或幅度来修改电刺激脉冲的能力。当起搏心脏时，这可以助于定制电刺激脉冲来有时候以降低的电池使用量捕获特定患者的心脏。对于神经刺激疗法，调整脉冲宽度和/或幅度可以对于特定应用助于定制疗法和/或助于使得疗法对于特定患者更有效。
在一些实施例中，LCP 100可以包括电感测模块106和机械感测模块108。电感测模块106可以配置为感测从电极114’和/或电极114传导到电感测模块106的内在心电信号。例如，电感测模块106可以电连接到一个或多个电极114’和/或电极114，以及电感测模块106可以配置为接收经过电极114’和/或电极114传导的心电信号。在一些实施例中，心电信号可以表示来自被植入LCP 100的腔室的本地信息。例如，如果LCP 100植入在心脏的心室中，则由LCP 100经过电极114’和/或电极114感测到的心电信号可以表示心室心电信号。机械感测模块108可以包括或者电连接到各种传感器如加速计、血压传感器、心音传感器、血氧传感器和/或用于测量心脏和/或患者的一个或多个生理参数的其他传感器。机械感测模块108当出现时可以采集来自传感器的用于指示各种生理参数的信号。电感测模块106和机械感测模块108可以连接到处理模块110并且可以提供用于表示感测到的心电信号和/或生理信号的信号给处理模块110。虽然关于图1被描述为独立的感测模块，但是在一些实施例中，电感测模块106和机械感测模块108可以组合成单个模块。
处理模块110可以配置为控制LCP 100的操作。例如处理模块110可以配置为接收来自电感测模块106的心电信号和/或来自机械感测模块108的生理信号。基于接收到的信号，处理模块110可以确定例如心律不齐的发生和类型。处理模块110可以进一步接收来自通信模块102的信号。在一些实施例中，处理模块110可以另外使用该接收到的信号来确定心律不齐的发生和类型。然而，在其他实施例中，LCP 100可以使用接收到的信息代替从电感测模块106和/或机械感测模块108接收到的信号——例如如果接收到的信息比从电感测模块106和/或机械感测模块108接收到的信号更准确或者如果电感测模块106和/或机械感测模块108已被禁止或从LCP 100省略。
基于确定的心律不齐，处理模块110可以控制脉冲生成器模块104根据一个或多个电刺激链路生成电刺激脉冲以治疗确定的心律不齐。处理模块110可以例如控制脉冲生成器模块104生成具有变化的参数和不同的次序的起搏脉冲以实现一个或多个电刺激疗法。例如，通过控制脉冲生成器模块104传递心律缓慢起搏疗法，处理模块110可以控制脉冲生成器模块104传递设计为以规律的时间间隔捕获患者的心脏的起搏脉冲以助于防止患者的心脏下降到低于预定阈值。在一些情况中，起搏的速率可以随着患者的活动等级增加而增加(例如速率自适应起搏)。对于ATP疗法，处理模块110可以控制脉冲生成器模块104以比患者的内在心率更快的速率传递起搏脉冲以试图迫使心脏响应于所传递的起搏脉冲而不是响应于内在心电信号而跳动。在心脏跟随起搏脉冲之后，处理模块110可以控制脉冲生成器模块104将传递的起搏脉冲的速率降低到更安全的等级。在CRT中，处理模块110可以控制脉冲生成器模块104与另一个设备协作地传递起搏脉冲，以导致心脏更有效地收缩。在脉冲生成器模块104能够生成用于除颤/心律转复疗法的除颤和/或心律转复脉冲的情况中，处理模块110可以控制脉冲生成器模块104生成该除颤和/或心律转复脉冲。在一些情况中，处理模块110可以控制脉冲生成器模块104生成电刺激脉冲以提供与上文所述的那些实例不同的电刺激疗法。
除了控制脉冲生成器模块104生成不同类型和不同次序的电刺激脉冲之外，在一些实施例中，处理模块110还可以控制脉冲生成器模块104生成具有变化的脉冲参数的各种电刺激脉冲。例如，每个电刺激脉冲可以具有脉冲宽度和脉冲幅度。处理模块110可以控制脉冲生成器模块104生成具有具体脉冲宽度和脉冲幅度的各种电刺激脉冲。例如如果电刺激脉冲未有效捕获心脏则处理模块110可以导致脉冲生成器模块104调整电刺激脉冲的脉冲宽度和/或脉冲幅度。各种电刺激脉冲的具体参数的该控制可以助于LCP 100提供电刺激疗法的更有效的传递。
在一些实施例中，处理模块110可以进一步控制通信模块102发送信息到其他设备。例如，处理模块110可以控制通信模块102生成一个或多个通信脉冲，用于与设备系统的其他设备通信。例如，处理模块110可以控制通信模块102生成具体次序的通信脉冲，其中具体次序传递不同的信息。通信模块102还可以接收用于处理模块110的潜在动作的通信信号。
在进一步的实施例中，处理模块110可以控制切换电路，通信模块102和脉冲生成器模块104可以通过该切换电路传递通信脉冲和/或电刺激脉冲到患者的组织。如上所述，通信模块102和脉冲生成器模块104可以包括用将一个或多个电极114’和/或电极114连接到通信模块102和/或脉冲生成器模块104的电路，从而这些模块可以传递通信脉冲和电刺激脉冲到患者的组织。被通信模块102和/或脉冲生成器模块104用于传递通信脉冲和电刺激脉冲的一个或多个电极的具体组合可以影响通信脉冲的接收和/或电刺激脉冲的有效性。虽然描述了通信模块102和脉冲生成器模块104中的每一个可以包括切换电路，但是在一些实施例中，LCP 100可以具有连接到通信模块102、脉冲生成器模块104电极114’和/或电极114的单个切换模块。在该实施例中，处理模块110可以控制切换模块适当地连接模块102/104和电极114/114’。
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更少的电力同时能够维持基本功能，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等。该可编程微处理器即使在制造之后也可以允许用户调整LCP 100的控制逻辑，因而与使用预编程芯片时相比允许LCP 100的更大的灵活性。
在附加实例中，处理模块110可以包括存储器电路，并且处理模块110可以将信息存储在存储器电路上以及从存储器电路读取信息。在其他实例中，LCP100可以包括与处理模块110通信的独立的存储器电路(未显示)，使得处理模块110可以从独立的存储器电路读取信息以及向独立的存储器写入信息。存储器电路无论是处理模块110的一部分还是与处理模块110分离，其可以是易失性存储器、非易失性存储器或者易失性存储器和非易失性存储器的组合。
能量存储模块112可以提供电源给LCP 100用于其操作。在一些实例中，能量存储模块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由其他合适材料制造。在其他实例中，能量存储模块112可以包括可再充电电池。在其他实例中，能量存储模块112可以包括其他类型能量存储设备如超级电容。
为了将LCP 100植入患者身体，操作员(例如医师、临床医生等等)可以将LCP 100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可以例如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2描述了另一个医疗设备(MD)200的实施例，其可以操作以感测生理参数和/或参数并且递送一种或多种类型的电刺激疗法到患者的组织。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和能量存储模块218。这些模块202,204,206,208和210中的每一个可以类似于LCP 100的模块102,104,106,108和110。另外，能量存储设备218可以类似于LCP 100的能量存储设备112。然而，在一些实例中，MD 200可以在外壳220中具有更大的体积。在该实例中，MD 200可以包括更大的能量存储设备218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MD 200可以是如图1中所示的另一个无引线设备，但是在一些实例中，MD 200可以包括引线如引线212。引线212可以包括在位于外壳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的外壳200。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距外壳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。在其他情况中，一个或多个电极214可以定位在皮下但是与患者心脏邻近。引线214可以传导内在生成的心电信号到引线212。引线212因而可以传导接收到的心电信号到MD 200的模块202、204、206和208中的一个或多个。在一些情况中，MD200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(直接或间接)传导电刺激信号到患者的心脏组织。MD 200还可以包括未设置在引线212上的一个或多个电极214。例如，一个或多个电极214可以直接连接到外壳220。
在一些实施例中，引线212可以另外包括一个或多个传感器如加速计、血压传感器、心音传感器、血氧传感器和/或配置为测量心脏和/或患者的一个或多个生理参数的其他传感器。在该实例中，机械感测模块208可以与引线212电通信并且可以接收从该传感器生成的信号。
虽然不需要，但是在一些实例中，MD 200可以是植入式医疗设备。在该实例中，MD200的外壳220可以例如植入到患者的经胸区域。外壳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。在该实施例中，引线212可以植入在患者中的一个或多个各种位置如在患者心脏中、邻近患者的心脏、邻近患者的脊骨或者任意其他希望位置。
在一些实施例中，MD 200可以是植入式心脏起搏器(ICP)。在这些实施例中，MD200可以具有一个或多个引线例如引线212，其植入到患者心脏上或中。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不齐。MD 200可以配置为经由植入心脏中的引线212传递CRT、ATP治疗、心动过缓疗法和/或其他疗法类型。在一些实施例中，MD 200可以另外配置为提供除颤/心律转复疗法。
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，以及响应于确定快速性心律失常的发生而传递除颤和/或转复疗法(例如通过传递除颤和/或转复脉冲到患者心脏)。在其他实例中，MD 200可以是皮下植入式心律转复除颤器(SICD)。在MD 200是SICD的实例中，其中一个引线212可以是皮下植入的引线。在MD 200是SICD的至少一些实例中，MD 200可以仅包括单个皮下植入的而在胸腔之外的引线，然而这不是必须的。
在一些实施例中，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电极214可以是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)。在该实施例中，MD 200可以配置为传递各种类型的电刺激疗法，包括例如除颤疗法。
图3示出了医疗设备系统和可被医疗设备系统的多个医疗设备302、304、306和/或310用于通信的通信路径的实施例。在所示实施例中，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所述的设置在患者身体外部的设备。其他传感器/设备310也可以是前文关于MD 200所述的任意设备如ICP、ICD和SICD。其他传感器/设备310也可以包括用于采集与患者有关的信息的各种诊断传感器如加速计或血压传感器等等。在其他情况中，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的一个或多个设备302/304、306和310可以基于发送的心律不齐确定来采取行动，如通过传递合适的电刺激到患者心脏。系统300的设备302/304、306和310中的一个或多个可以另外经由通信路径发送命令和响应消息。命令消息可以导致接收设备采取具体行动，而响应消息可以包括请求的信息或者接收设备事实上确实接收到发送的消息或数据的确认。
设想系统300的各个设备可以使用传导的信号、RF信号、电感耦合、光信号、声信号或适用于通信的任意其他信号经由路径308来通信。在一些实例中，系统300的各种设备可以使用不同信号类型经由路径308通信。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，LCP302/304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。这仅仅是一个实例。
在一些情况中，系统300的各种设备可以使用传导的通信信号经由路径308来通信。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。在该实施例中，传递的传导通信信号(例如脉冲)可以与起搏脉冲、除颤和/或心律转复脉冲或其他电刺激疗法信号不同。系统300的设备可以例如以亚阈值(例如不捕获心脏、横膈膜神经和/或其他组织)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/脉冲宽度可以高于捕获阈值，但是可以在心脏的无关周期期间传递。例如，传递的电通信脉冲的幅度/脉冲宽度可以高于心脏的捕获阈值但是可以在心脏的不反应周期期间传递以及/或者根据希望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4和图5显示了可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。例如，系统可以包括多个设备，其植入在患者中并且配置为感测生理信号，确定心律不齐的发生以及传递电刺激以治疗检测到的心律不齐。在图4中，LCP 402显示为固定到心脏410的右心室的内部，以及脉冲生成器406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(SICD)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。LCP 402可以例如经由通信路径308与SICD通信。图4中描述的LCP 402、脉冲生成器406、引线412和电极408a-c的位置仅仅是示例性的。在系统400的其他实例中，LCP 402可以根据希望定位在心脏的左心室、右心房或左心房中。在其他实施例中，LCP 402可以邻近心脏410或者甚至远离心脏410外部地植入。
在图5中，LCP 502显示为固定到心脏510的左心室中，并且脉冲生成器506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，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，如经由通信路径308。如同图4，图5中描述的LCP 502、脉冲生成器506、引线512和电极504a-c仅仅是示例性的。在系统500的其他实施例中，LCP 502可以根据希望定位在心脏的右心室、右心房或左心房中。在其他实施例中，LCP 502可以邻近心脏510或者甚至远离心脏510外部地植入。另外，在一些实施例中，引线512和/或电极504a-c可以设置在心脏510的不同腔室中，或者脉冲生成器可以包括在心脏510中或邻近心脏510设置的附加的引线和/或电极。
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。作为一个实施例，外部支持设备420与脉冲生成器406之间的通信经由无线模式执行，并且脉冲生成器406与LCP 402之间的通信经由传导模式执行。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之间的通信可以经由通信模块。
图4和图5仅示出了可配置为根据本文所述的技术来操作的医疗设备系统的几个实例。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，适用于根据本文所述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而有或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。另一个实施例可以包括沿经静脉起搏器植入以及具有或不具有植入的SICD的一个或多个LCP。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4和图5中所述那些不同。因此，应该认识到可以根据本文所述的技术来操作与图4和图5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。图4和图5中显示的实例不应被视为进行限制。
使用图4的系统作为一个实例，可以包括脉冲生成器406的LCP 402和ICD(其可以是非皮下植入的设备或者皮下植入的设备SICD)可以确定心律不齐的发生以及区分不同类型的心律不齐。在一些实施例中，心律不齐类型包括心动过速心律不齐，以及ICD可以进一步识别心动过速心律不齐的发生作为具体类型的心动过速心律不齐。如本文所使用的，术语心动过速心律不齐可以包括室颤(VF)。基于确定的心动过速心律不齐类型，LCP 402和/或ICD可以实现不同的治疗协议。通过定制具体的治疗协议给不同类型心动过速心律不齐，LCP402和ICD的系统可以更有效节省电池寿命和/或降低传递到患者的不必要的除颤和/或心律转复脉冲的数量——其对于患者可能是痛苦和恐慌的体验。
在一些实施例中，ICD可以操作以根据图6中所示的说明性流程图确定心动过速心律不齐的发生和心动过速心律不齐的类型。为了确定心动过速心律不齐的发生，ICD可以首先如在601处将检测到的心率与第一心率阈值比较。在一些实施例中，ICD可以例如使用接收到的心电信号与其他接收到的生理信号相结合来确定心率。如果ICD确定心率大于或等于第一心率阈值，则ICD可以如在603处将当前心跳的心电信号的形态与正常心跳的模板的形态比较。ICD可以例如离析当前心跳的QRS复波周围的心脏电活动区域以及在离析的QRS复波(或者其一部分)的形态与包含正常心跳的QRS复波(或者其一部分)的模板执行相关性分析。如果当前心跳与模板心跳之间的相关性大于或等于第一相关性阈值，则ICD可以如在605处确定没有心动过速心律不齐出现。在这些情况中，心跳可能由于运动或压力或一些其他因素而不是由于异常生理过程而升高。
然而，如果当前心跳与模板心跳之间的相关性不大于或等于第一相关性阈值，则ICD可以如在607处将当前心跳的形态与一个或多个以前心跳的形态比较。ICD可以例如离析当前心跳和以前心跳的QRS复波以及执行两个心跳的形态之间的相关性分析。如果两个心跳之间的相关性小于第二相关性阈值，则ICD可以如在609处确定心动过速心律不齐是多形性室性心动过速(PVT)。然而，如果两个心跳之间的相关性大于或等于第二相关性阈值，则ICD可以如在611处进一步将当前心跳的QRS复波的宽度与模板正常心跳的QRS复波的宽度比较。ICD可以例如将当前心跳与模板心跳之间的QRS宽度的差与QRS宽度阈值比较。如果QRS宽度的差大于或等于QRS宽度阈值(指示当前心跳的QRS复波的宽度比模板心跳的QRS复波的宽度大阈值数量)，则ICD可以如在613处确定心动过速心律不齐是单形性室性心动过速(MVT)。然而，如果ICD确定QRS宽度的差小于QRS宽度阈值(指示当前心跳的QRS复波的宽度窄于模板心跳的QRS复波的宽度)，则ICD可以如在615处确定心动过速心律不齐是室上性心动过速(SVT)。
应该注意到，图6的流程图仅仅是ICD可以确定心动过速心律不齐的发生和/或区分心动过速心律不齐的类型的一个实施例。例如，在一些附加实施例中，ICD可以进一步将确定的心率与第二心率阈值比较，其中，第二心率阈值大于第一心率阈值。如果该心率大于或等于第二心率阈值则ICD可以确定心脏是心室颤动(VF)。另外或可替换地，在一些实施例中，ICD可以另外使用当前QRS复波的宽度和模板心跳的QRS复波的宽度来在步骤607执行当前心跳与模板心跳之间的相关性分析。当然，在其他实施例中，ICD可以使用不同的方法确定心动过速心律不齐的发生和区分各种类型的心动过速心律不齐，其可以包括比图6中所罗列的那些步骤更少或更多的步骤。
在ICD在不同类型心动过速心律不齐之间进行区分的情况中，ICD可以与LCP 402协调来实现不同的治疗协议。ICD可以例如在存储器中存储第一心动过速心律不齐类型集合。如果确定的心动过速心律不齐是第一心动过速心律不齐类型集合中的一个心动过速心律不齐类型，则ICD可以发送指令到LCP 402以开始ATP疗法的应用。在一些情况中，ICD还可以等待开始其电荷存储设备的充电以便除颤和/或心律转复疗法的传递。ICD可以随后监视心电信号以确定由LCP 402传递的ATP疗法是否终止了心动过速心律不齐。如果ICD确定心动过速心律不齐未被ATP终止，则ICD可以开始其电荷存储设备的充电以及在充电完成之后传递除颤和/或心律转复疗法。在确定ATP疗法的传递是否终止心动过速心律不齐时，ICD可以确定当前心率并且将其与阈值比较或者将其与检测到心动过速心律不齐时的心率比较。如果心率小于比较心率，则ICD可以确定心动过速心律不齐终止。在其他实施例中，ICD可以执行在图6中详述的过程来确定ATP疗法是否终止心动过速心律不齐。
在第一心动过速心律不齐类型集合的心动过速心律不齐的类型是可能易受到ATP疗法的影响的类型的实施例中，ICD可以通过等待充电其电荷存储设备直到确认ATP疗法无法终止心动过速心律不齐之后为止才节省能量。在一些实施例中，第一心动过速心律不齐类型集合的心动过速心律不齐的类型包括MVT。然而，在其他实施例中，PVT也可以包括在第一心动过速心律不齐类型集合中。在其他实施例中，SVT和/或VF也可以包括在第一心动过速心律不齐类型集合中。这些仅仅是实例。
在心动过速心律不齐的类型不是第一心动过速心律不齐类型集合的心动过速心律不齐的类型的实施例中，ICD可以不发送指令到LCP 402开始ATP疗法。相反，ICD可以开始电荷存储设备的充电以及在充电完成之后传递除颤和/或心律转复疗法。在一些实施例中，可以从第一心动过速心律不齐类型集合排除VF。在一些实施例中，可以从第一心动过速心律不齐类型集合排除PVT和/或SVT。
在一些实例中，ICD可以基于确定的心动过速心律不齐类型改变治疗协议。例如，如果ICD确定心动过速心律不齐是第一心动过速心律不齐类型集合中的一个心动过速心律不齐的类型，则ICD可以发送指令到LCP 402以开始ATP疗法，而且还开始充电其电荷存储设备以便除颤和/或心律转复疗法的传递。当确定的心动过速心律不齐类型有一些不凡的机会使得ATP疗法会终止心动过速心律不齐但是仍然不可能成功时，最好应用这个。当充电电荷存储设备时以及当LCP 402传递ATP疗法时，ICD可以监视心电活动。如果ATP疗法的传递确实实际上终止了心动过速心律不齐，则ICD可以终止充电其电荷存储设备，并且随后接下来缓慢地泄露积蓄的电荷而不执行除颤和/或心律转复疗法。在该实施例中，ICD可以通过不去非必要地完全充电其电荷存储设备来节省一些能量并且还可以不通过传递非必要的除颤和/或心律转复脉冲而伤害或惊吓患者。如果ATP疗法的传递无法终止心动过速心律不齐，则ICD可以继续完全充电电荷存储设备以及执行除颤和/或心律转复疗法。在这些实施例中，通过比确定的心动过速心律不齐是第一心动过速心律不齐类型集合中的一个的情况下更早地开始充电其电荷存储设备，ICD已经在心动过速心律不齐的检测和除颤和/或心律转复疗法的传递之间节省了时间。在一些实施例中，当心动过速心律不齐是PVT或SVT型心动过速心律不齐时，无需首先等待ATP疗法，电荷存储设备就可以开始充电。在其他实施例中，当心动过速心律不齐是MVT和/或VF时，无需首先等待ATP疗法，电荷存储设备就可以开始充电。
在附加的或可替换的实施例中，发送到LCP 402以开始ATP疗法的指令可以包括用于定义ATP疗法的一个或多个特征的一个或多个ATP参数。例如，指令可以指定在终止ATP疗法协议之前LCP 402可以尝试的ATP疗法尝试的数量。例如，如果心动过速心律不齐类型是第一心动过速心律不齐类型，则ICD可以发送这样一种指令即LCP 402应该尝试定义的ATP疗法两次或三次或五次或任意其他合适的次数。每个尝试可以包括应用多个间隔的ATP脉冲到心脏。如果心动过速心律不齐是与第一心动过速心律不齐类型不同或可区分的第二心动过速心律不齐类型，则ICD可以发送这样一种指令即LCP 402应该仅提供一个ATP疗法尝试。例如，对于MVT，ATP疗法可以应用在多个突发(有时候由临床医生编程)中，并且考虑到当应用于MVT时ATP疗法具有更高成功机会，可以允许多次以终止心动过速心律不齐，而对于其它类型的心动过速心律不齐(例如PVT、SVT和/或VF)，考虑到ATP疗法的更小的成功机会，更合适的可能是应用单个突发(单个ATP尝试)来助于降低除颤和/或心律转复疗法的时间。
在一些情况中，ICD的电荷存储设备可以与由LCP 402传递的ATP疗法并行地充电。在这些情况中，发送到LCP 402的指令可以命令LCP 402执行多个ATP疗法尝试，这往往占满被ICD用来充电其电荷存储设备的时间。在其他实例中，ICD发送到LCP 402命令LCP 402执行ATP疗法的每个指令可以指示LCP402执行单个ATP尝试。然后，如果ICD确定ATP尝试没有终止检测到的心动过速心律不齐，则ICD可以发送附加的指令到LCP 402以执行另一个ATP尝试。在该实例中，结果可能是ICD可以取决于ATP疗法是否成功而发送不同数量的指令来传递ATP疗法。
ICD发送到LCP 402命令LCP 402执行ATP的指令可以定义ATP疗法的一个或多个特征。示例性参数可以包括在每个ATP疗法尝试期间由LCP 402传递的ATP突发——例如ATP脉冲——的数量。该参数可以增补或替换多个ATP疗法尝试。在一些实施例中，可以对于每个ATP疗法尝试不同地指定ATP脉冲数量，其中指示LCP 402执行多个ATP疗法尝试。并且，可以取决于确定的心动过速心律不齐类型不同地指定ATP脉冲数量。另外，在到LCP 402的指令包括ATP疗法尝试数量的情况中，在一些实施例中指令可以进一步包括在每个ATP疗法尝试期间的ATP脉冲传递的具体速率。如同每个尝试中的ATP脉冲的数量，在ATP疗法尝试之间和/或取决于检测到的心动过速心律不齐类型，ATP脉冲传递的速率可以不同。另外或可替换地，指令可以指定ATP疗法尝试之间的中断周期的长度。其他示例性参数可以包括在每个ATP疗法尝试期间要传递的ATP脉冲的脉冲幅度和/或脉冲宽度。如同其他参数，指令可以对于每个ATP疗法尝试和/或基于确定的心动过速心律不齐类型，指定不同的幅度和/或脉冲宽度。
ICD发送到LCP 402命令LCP 402执行ATP的指令可以另外或可替换地包括根据多个方法中的一个来执行ATP的指令。根据突发方法，LCP 402可以以每个电刺激脉冲之间恒定的时间间隔传递连续的电刺激脉冲。另外，当根据突发方法传递ATP时LCP 402可以以电刺激脉冲的每个序列之间恒定的时间间隔传递电刺激脉冲的每个序列。在另一个方法即坡道(ramp)方法中，LCP 402可以在电刺激脉冲的序列或者ATP疗法尝试之中以连续的电刺激脉冲的每个对之间减小的时间间隔传递电刺激脉冲。在另一个方法即扫描方法中，LCP 402可以以电刺激脉冲的每个序列中的电刺激脉冲之间的时间间隔对于每个连续的电刺激脉冲序列减小的方式传递电刺激脉冲序列或者ATP疗法尝试。在一个方法即坡道/扫描中，LCP402可以根据坡道方法和扫描方法的特征传递ATP疗法。
在ICD包括根据具体方法来执行ATP的指令的实施例中，具体方法可以至少部分地取决于心律不齐类型。例如，如果心律不齐是第一心律不齐类型集合中的一个，则ICD可以发送消息到LCP 402以根据突发方法执行ATP疗法。然而，如果心律不齐类型是第二心律不齐类型集合中的一个，则ICD可以发送消息到LCP 402以根据坡道方法执行ATP疗法。当然在其他实施例中，与每个心律不齐类型相关联的方法类型可以不同并且可以是突发、坡道、扫描或坡道/扫描方法中的任意一个。
在一些实施例中，第一和第二心动过速心律不齐类型集合的心动过速心律不齐的类型可以是用户可编程的。例如，如关于图4所述的，包括脉冲生成器406的ICD可能能够与在一些实施例中可用作编程器的外部支持设备420通信。临床医生可以与编程器交互以指定将哪个心动过速心律不齐类型包括在第一心动过速心律不齐类型集合和第二心动过速心律不齐类型集合中的每个中，以及哪个心动过速心律不齐类型不包括在任意一个集合中。在一些情况中，第一心律不齐类型集合和第二心律不齐类型集合可以是相同的心律不齐类型。在其他实例中，第一心律不齐类型集合和第二心律不齐类型集合可以是互斥的。在其他实例中，第一心律不齐类型集合和第二心律不齐类型集合可以共享一个或多个公共心律不齐类型。
在一些实施例中，第一和第二心动过速心律不齐类型集合的心动过速心律不齐的类型可以至少部分地取决于对ICD供电的能量存储模块的电荷等级。例如，ICD可以确定能量存储模块218的剩余能量容量的百分比。ICD可以例如在第一心动过速心律不齐类型集合中以MVT和PVT开始，以及在第二心动过速心律不齐类型集合以PVT开始。即如果检测到MVT或PVT中的任意一个，ICD可以可以发送指令到LCP 402以由LCP 402开始应用ATP疗法。如果检测到PVT，则ICD可以开始电荷存储设备的充电，以及如果检测到MVT，则ICD可以等待开始充电电荷存储设备直到ATP有机会终止心动过速心律不齐为止。在ICD确定能量存储模块218的剩余能量容量的百分比下降到低于例如50％之后，ICD可以推荐和/或自动地从第一心动过速心律不齐类型集合去除PVT。然后，如果ICD检测到PVT则ICD可以不发送指令到LCP402以由LCP 402开始应用ATP疗法。从第一心动过速心律不齐类型集合去除PVT可以通过在ATP疗法较不可能成功(例如PVT对MVT)的情况中不执行ATP疗法，助于增加ICD的电池的剩余寿命。这仅仅是一个实例。在其他实施例中，可以从每个集合去除、增加或删除不同类型的心动过速心律不齐。在一些情况中，一个或多个阈值可用于调整在每个心动过速心律不齐集合中具有哪些心动过速心律不齐类型。
图7是可以由在一些实施例中可以是ICD的医疗设备如图2中所示的医疗设备实现的说明性方法700的流程图。虽然将关于MD 200描述图7的方法，但是可以通过任意合适的医疗设备或者医疗设备系统执行图7的说明性方法。
在一些实施例中，MD 200可以如701处所示确定心律不齐的发生。在一些情况中，MD 200可以根据图6的流程图确定心律不齐并且特别是心动过速心律不齐的发生。然而，在其他实施例中，MD 200可以使用附加的或可替换的技术确定心律不齐的发生。在确定确定心律不齐的发生之后，MD 200可以如703处所示从两个或更多个心律不齐类型确定检测到的心律不齐的类型。例如MD 200可以在两个或更多个不同的心动过速心律不齐类型之间进行区分。在MD 200在不同的心动过速心律不齐类型之间进行区分的实施例中，MD 200可以根据图6中详述的方法来操作。然而，在其他实施例中，MD 200可以与关于图6的描述不同地操作以在心动过速心律不齐类型之间进行区分。
在确定心律不齐类型之后，如果确定的心律不齐类型是第一心律不齐类型集合中的一个，则MD 200可以如705处所示发送指令给无引线心脏起搏器(LCP)接收以由LCP开始应用ATP疗法。在一些实施例中，指令可以包括用于定义ATP疗法的特征的一个或多个参数。一些示例性参数包括ATP疗法尝试的数量、每个ATP疗法尝试中的ATP突发的数量、ATP疗法尝试之间的中断的长度、每个ATP突发的幅度和/或脉冲宽度以及其他参数。如果确定的心律不齐类型不是第一心律不齐类型集合中的一个，则MD 200可以如707处所示不发送指令到LCP。
在一些附加或可替换实施例中，如果确定的心律不齐类型是第二心律不齐类型集合中的一个，则除了发送指令之外，MD 200可以进一步开始充电电荷存储设备(例如可以是脉冲生成器模块204的一部分的电荷存储设备)。但是如果确定的心律不齐类型不是第二心律不齐类型集合中的一个，则MD 200可以等待充电电荷存储设备直到确认传递的ATP疗法无法终止心动过速心律不齐之后为止。
图8是可以由在一些实施例中可以是ICD的医疗设备如图2中所示的医疗设备实现的说明性方法800的流程图。虽然将关于MD 200描述图8的方法，但是可以通过任意合适的医疗设备或者医疗设备系统执行图8的说明性方法。
在一些实施例中，MD 200可以如801处所示确定心律不齐的发生。在一些情况中，MD 200可以根据图6的流程图确定心律不齐并且特别是心动过速心律不齐的发生。然而在其他实施例中，MD 200可以使用附加的或可替换的技术确定心律不齐的发生。在确定心律不齐的发生之后，MD 200可以如803处所示发送指令给无引线心脏起搏器(LCP)接收以开始应用ATP疗法。
在发送指令之后，MD 200可以如805处所示从两个或更多个心律不齐类型确定检测到的心律不齐的类型。例如MD 200可以在两个或更多个不同的心动过速心律不齐类型之间进行区分。在MD 200不同的心动过速心律不齐类型之间进行区分的实施例中，MD 200可以根据图6中详述的方法来操作。然而，在其他实施例中，MD 200可以与关于图6的描述不同地操作以在心动过速心律不齐类型之间进行区分。
在确定心律不齐类型之后，如果确定的心律不齐类型是第一心律不齐类型集合中的一个，则MD 200可以如807处所示等待开始充电电荷存储设备。例如，MD 200可以在LCP进行的ATP疗法的传递期间和之后监视接收到的心电信号。在这些实施例中，MD 200可以通过等待直到确认ATP疗法的传递未终止心动过速心律不齐为止来尝试节省电池能量。在MD200确认ATP疗法的传递无法终止心动过速心律不齐之后，MD 200可以开始充电其电荷存储设备以便传递除颤和/或心律转复疗法。在ATP疗法的传递确实终止心动过速心律不齐的实例中，MD 200已通过不充电其电荷存储设备节省了能量。
然而，如果确定的心律不齐类型不是第一心律不齐类型集合中的一个，则MD 200可以如809处所示开始充电其电荷存储设备。在一些实施例中，当充电其电荷存储设备时，MD 200可以监视接收到的心电信号。MD 200可以至少部分地基于接收到的信号确定通过LCP进行的ATP疗法的传递是否终止了心动过速心律不齐。如果MD 200确定通过LCP进行的ATP疗法的传递终止了心动过速心律不齐，则MD 200可以停止充电其电荷存储设备。MD 200然后可以缓慢泄露积蓄的电荷。然而，如果MD 200确定ATP疗法的传递没终止心动过速心律不齐，则MD 200可以在完成其电荷存储设备的充电之后传递除颤和/或心律转复疗法。
用于确定心动过速心律不齐的发生以及在各种心动过速心律不齐类型之间进行区分的以上描述仅作为实例而言使用包括ICD/SICD和LCP的系统。在其他实施例中，其他设备可以用作实现所公开的技术的系统的一部分。在其他实施例中，实现所公开的技术的系统可以包括附加的设备。在该实施例中，可以根据希望在设备之间协调以确定心动过速心律不齐的发生、在各种心动过速心律不齐类型之间进行区分、传递ATP疗法和/或传递除颤和/或心律转复疗法。
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)

1.一种用于传递除颤电击到患者的心脏的皮下植入式心律转复除颤器(SICD)，所述SICD包括：
两个或更多个电极；
电荷存储设备，用于存储能够被传递以经由两个或更多个电极来电击所述心脏的电荷；
控制器，可操作地耦接到所述两个或更多个电极和所述电荷存储设备，所述控制器配置为：
经由经两个或更多个电极接收到的心脏信号监视所述患者的心脏的心脏活动；
基于所述心脏活动，检测心律不齐的发生；
从两个或更多个类型的心律不齐，确定检测到的心律不齐的类型；
如果确定的心律不齐的类型是第一心律不齐类型集合中的一种，则经由所述两个或更多个电极发送指令给无引线心脏起搏器(LCP)接收以由所述LCP开始应用ATP疗法；以及
如果确定的心律不齐的类型不是第一心律不齐类型集合中的一种，则不发送所述指令。
2.根据权利要求1所述的SICD，其中，所述指令还包括用于定义所述ATP疗法的一个或多个特征的一个或多个ATP参数。
3.根据权利要求2所述的SICD，其中，所述ATP疗法的所述一个或多个特征包括ATP的方法。
4.根据权利要求1-3中的任意一个所述的SICD，其中，所述控制器进一步配置为：
如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则开始所述电荷存储设备的充电；以及
如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则等待开始所述电荷存储设备的充电。
5.根据权利要求4所述的SICD，其中，如果发送指令以由所述LCP开始应用ATP疗法，则所述控制器进一步配置为确定由所述LCP进行的所述ATP疗法的应用是否成功地终止所述心律不齐，以及如果是，则如果确定的心律不齐的类型不是第二心律不齐类型集合中的一种，则不开始所述电荷存储设备的充电。
6.根据权利要求4-5中的任意一个所述的SICD，其中，如果发送指令以由所述LCP开始应用ATP疗法，则所述控制器进一步配置为确定由所述LCP进行的所述ATP疗法的应用是否成功地终止所述心律不齐，以及如果是，则如果确定的心律不齐的类型是第二心律不齐类型集合中的一种，则终止所述电荷存储设备的充电。
7.根据权利要求1-6中的任意一个所述的SICD，其中，所述第一心律不齐类型集合包括单形性室性心动过速(MVT)。
8.根据权利要求4-7中的任意一个所述的SICD，其中，所述第二心律不齐类型集合包括多形性室性心动过速(PVT)、室上性心动过速(SVT)和心室颤动(VF)中的一个或多个。
9.根据权利要求4-7中的任意一个所述的SICD，其中，所述第二心律不齐类型集合包括多形性室性心动过速(PVT)。
10.根据权利要求4-7中的任意一个所述的SICD，其中，所述第二心律不齐类型集合包括室上性心动过速(SVT)。
11.根据权利要求8-10中的任意一个所述的SICD，其中，所述第二心律不齐类型集合包括单形性室性心动过速(MVT)。
12.根据权利要求4-10中的任意一个所述的SICD，其中，所述第一心律不齐类型集合和所述第二心律不齐类型集合共享一个或多个公共心律不齐类型。
13.根据权利要求1-12中的任意一个所述的SICD，其中，所述第一心律不齐类型集合和所述第二心律不齐类型集合中的所述心律不齐类型是用户可选择的。
14.根据权利要求1-13中的任意一个所述的SICD，其中，所述SICD进一步包括能量存储模块，其中，所述第一心律不齐类型集合中的所述心律不齐类型至少部分地取决于所述能量存储模块的电荷等级。
15.根据权利要求1-14中的任意一个所述的SICD，其中，为了从两个或更多个类型的心律不齐确定检测到的心律不齐的类型，所述控制器配置为将所述心脏信号与一个或多个模板比较。
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US11020595B2 (en) 2021-06-01
US20160228718A1 (en) 2016-08-11
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