CN107206242A - 用于电刺激治疗的安全递送的***和方法 - Google Patents

用于电刺激治疗的安全递送的***和方法 Download PDF

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CN107206242A
CN107206242A CN201680008968.6A CN201680008968A CN107206242A CN 107206242 A CN107206242 A CN 107206242A CN 201680008968 A CN201680008968 A CN 201680008968A CN 107206242 A CN107206242 A CN 107206242A
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lcp
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CN107206242B (zh
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保罗·荷斯康
雅各布·M·路德维格
兰斯·E·朱费尔
基思·R·迈莱
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Cardiac Pacemakers Inc
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    • 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
    • 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
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • 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
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
    • 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
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

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Abstract

公开了用于治疗心律失常的***和方法。在一个实施例中，LCP包括：外壳；多个电极，其用于感测从外壳外部发出的电信号；能量存储模块，其被布置在外壳内；以及控制模块，其被布置在外壳内并可操作地耦接到多个电极。控制模块可以被配置为经由多个电极中的两个或更多个接收电信号，并确定接收到的电信号是否指示用于LCP递送ATP治疗的命令。如果接收到的电信号指示用于LCP递送ATP治疗的命令，则控制模块可另外确定LCP的触发的ATP治疗模式是否被使能。如果触发的ATP治疗模式被使能，则控制模块可以致使LCP经由多个电极递送ATP治疗。

Description

用于电刺激治疗的安全递送的***和方法
相关申请的交叉引用
本申请要求于2015年2月6日提交的美国临时专利申请序列号62/113,150的权益，其每个的公开通过引用并入本文。
技术领域
本公开一般涉及用于治疗心律失常的***、装置和方法，并且更具体地涉及用于检测心律失常并安全地递送电刺激治疗以治疗检测到的心律失常的***、装置和方法。
背景技术
起搏仪器可以被用于治疗患有各种心脏疾病的患者，该心脏疾病可能导致心脏将足够量的血液递送到患者身体的能力降低。这些心脏疾病可导致快速、不规则和/或低效的心脏收缩。为了帮助减轻这些疾病中的某些，各种装置(例如，起搏器、除颤器等)可以被植入患者的身体中。这样的装置可以监视并向心脏提供电刺激，以帮助心脏以更正常、高效和/或安全的方式操作。在一些情况下，患者可以具有多个植入装置。
发明内容
本公开一般涉及用于治疗心律失常的***、装置和方法，并且更具体地涉及用于检测心律失常并安全递送电刺激治疗、诸如抗心动过速起搏(ATP)治疗的***、装置和方法，以治疗检测到的心律失常。
在一个实施例中，无引线心脏起搏器(LCP)可以包括：外壳；多个电极，其用于感测从外壳外部发出的电信号；能量存储模块，其被布置在外壳内；以及控制模块，其被布置在外壳内并可操作地耦接到多个电极。控制模块可以被配置为经由多个电极中的两个或更多个接收电信号，并且确定接收到的电信号是否指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令。如果接收到的电信号指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令，则控制模块可另外确定LCP的触发ATP治疗模式是否被使能。如果触发的ATP治疗模式被使能，则控制模块可以致使LCP经由多个电极中的两个或更多个递送ATP治疗。
可替代地或另外地，在上述实施例中，如果触发的ATP治疗模式被使能，则控制模块还可以被配置为响应于该命令来确定是否递送ATP治疗，并且如果确定递送ATP治疗，则经由多个电极中的两个或更多个递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为：如果触发的ATP治疗模式被使能，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为：如果从接收到的电信号确定出的心率高于心律失常阈值，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为保持已经作为递送的ATP治疗的一部分被递送的ATP治疗突发的数量的计数，并且其中控制器模块还被配置为：如果ATP治疗突发的数量没有超过ATP治疗突发计数阈值，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，如果ATP治疗突发的数量已经超过ATP治疗突发计数阈值，则控制模块还可以被配置为将错误信号传送到另一个医疗装置。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为确定经由多个电极中的两个或更多个接收到的心脏信号的信号形态类型，并且其中所述控制器模块还被配置为：如果确定出的信号形态类型是预定信号形态类型，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括单形性室性心动过速(MVT)。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括多形性室性心动过速(PVT)。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括室上性心动过速(SVT)。
可替代地或另外地，在上述实施例中的任一个中，指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令的信号可以包括由远程医疗装置产生的多个通信脉冲。
可替代地或另外地，在上述实施例中的任一个中，指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令的信号可以包括来自远程医疗装置的作为单向通信路径的一部分的多个通信脉冲。
可替代地或另外地，在上述实施例中的任一个中，多个通信脉冲可以没有用于错误检查单向通信路径的错误检查信息。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为：在经由多个电极中的两个或更多个递送ATP治疗之后递送休克后起搏治疗(post shock pacingtherapy)。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为在递送ATP治疗之后约30-60秒之间递送休克后打包治疗(post shock packingtherapy)。
在另一个实施例中，无引线心脏起搏器(LCP)可以包括外壳；多个电极，其用于感测从外壳外部发出的电信号；能量存储模块，其被布置在外壳内；以及控制模块，其被布置在外壳内并且可操作地耦接到多个电极。控制模块可以被配置为经由多个电极中的两个或更多个接收电信号，并且确定接收到的电信号是否指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令。如果接收到的电信号指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令，则控制模块还可以被配置为确定LCP的触发的ATP治疗模式是否被使能。如果触发的ATP治疗模式被使能，则控制模块可以致使LCP经由多个电极中的两个或更多个来递送ATP治疗。
可替代地或另外地，在上述实施例中，如果触发的ATP治疗模式被使能，则控制模块还可以被配置为响应于该命令来确定是否递送ATP治疗，并且如果确定递送ATP治疗，则经由多个电极中的两个或更多个递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为：如果触发的ATP治疗模式被使能，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为：如果从接收到的电信号确定出的心率高于心律失常阈值，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为保持作为递送的ATP治疗的一部分已经被递送的ATP治疗突发的数量的计数，并且其中控制器模块还被配置为：如果ATP治疗突发的数量没有超过ATP治疗突发计数阈值，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以被配置为确定经由多个电极中的两个或更多个接收到的心脏信号的信号形态类型，并且其中所述控制器模块还被配置为：如果确定出的信号形态类型是预定信号形态类型，则确定递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括单形性室性心动过速(MVT)。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括多形性室性心动过速(PVT)。
可替代地或另外地，在上述实施例中的任一个中，预定信号形态类型可以包括室上性心动过速(SVT)。
在另一个实施例中，无引线心脏起搏器(LCP)可以包括：外壳，多个电极，其用于感测从外壳外部发出的电信号；能量存储模块，其被布置在外壳内；以及控制模块，其被布置在外壳内并且可操作地耦接到多个电极。控制模块可以被配置为经由多个电极中的两个或更多个接收电信号，并且确定接收到的电信号是否指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令。如果接收到的电信号指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令，则控制模块可以被配置为经由多个电极中的两个或更多个来递送ATP治疗。控制模块还可以被配置为保持与在预定时间段内作为递送的ATP治疗的一部分被递送的ATP治疗量有关的测量，并且如果与在预定时间段内递送的ATP治疗量有关的测量没有超过预定的ATP治疗阈值，则继续允许ATP治疗的递送。如果与在预定时间段内递送的ATP治疗量有关的测量超过了预定的ATP治疗阈值，则控制还可以停止ATP治疗的递送。
可替代地或另外地，在上述实施例中的任一个中，预定时间段可以在一小时至二十四小时之间。
可替代地或另外地，在上述实施例中的任一个中，与在预定时间段内作为递送的ATP治疗的一部分被递送的ATP治疗量有关的测量可以对应于指示在预定时间段内导致LCP递送ATP治疗的命令的被接收次数的ATP治疗递送计数。
可替代地或另外地，在上述实施例中的任一个中，与在预定时间段内作为递送的ATP治疗的一部分递送的ATP治疗量有关的测量可以对应于指示在预定时段内递送的ATP突发的数量的ATP突发计数。
可替代地或另外地，在上述实施例中的任一个中，接收到的电信号可以包括由远程医疗装置产生的多个通信脉冲。
可替代地或另外地，在上述实施例中的任一个中，接收到的电信号可以包括作为来自远程医疗装置的单向通信路径的一部分的多个通信脉冲。
可替代地或另外地，在上述实施例中的任一个中，多个通信脉冲可以没有(freefrom)用于错误检查单向通信路径的错误检查信息。
可替代地或另外地，在上述实施例中的任一个中，在递送ATP治疗之后，LCP还可以被配置为进入休克后起搏模式。
在又一个实施例中，无引线心脏起搏器(LCP)可以包括：外壳；多个电极，其用于感测从外壳外部发出的电信号；能量存储模块，其被布置在外壳内；以及控制模块，其被布置在外壳内并且可操作地耦接到多个电极。控制模块可以被配置为经由多个电极中的两个或更多个接收电信号，并且确定接收到的电信号是否指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令。如果接收到的电信号指示用于LCP递送抗快速性心律失常起搏(ATP)治疗的命令，则控制模块还可以确定LCP的触发ATP治疗模式是否被使能，并确定从接收到的电信号确定出的心率是否高于心律失常阈值。如果触发的ATP治疗模式被使能并且心率高于心律失常阈值，则控制模块可以致使LCP经由多个电极中的两个或更多个来递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，控制模块还可以保持与在预定时间段内递送的ATP治疗量有关的测量，并且其中所述控制模块还可以被配置为确定与在预定时间段内递送的ATP治疗量有关的测量是否超过预定的ATP治疗阈值，并且如果触发的ATP治疗模式被使能、心率高于心律失常阈值、并且与预定时间段内递送的ATP治疗量有关的测量值不超过预定的ATP治疗阈值，才致使LCP经由多个电极中的两个或更多个递送ATP治疗。
可替代地或另外地，在上述实施例中的任一个中，预定时间段在一小时至二十四小时之间。
上述发明内容并不意图描述本公开的每个实施例或每个实施方式。通过参考结合附图的以下描述和权利要求，本公开的优点和成就以及对本公开更全面理解将变得显而易见并且被领会到。
附图说明
结合附图而考虑各种说明性实施例的以下描述可更全面地理解本公开，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)的示意性框图；
图2是可以与图1的LCP一起使用的另一说明性医疗装置的示意性框图；
图3是包括彼此通信的多个LCP和/或其他装置的示例性医疗***的示意图；
图4是根据本公开的另一实施例的包括LCP和另一医疗装置的***的示意图；
图5是根据本公开的又一实施例的包括无引线心脏起搏器(LCP)和另一医疗装置的***的示意图；
图6A-图6B示出了根据本公开的又一实施例的示例通信脉冲序列；
图7是可以由医疗装置或医疗装置***诸如关于图1-图5描述的说明性医疗装置和医疗装置***而实施的说明性方法的流程图；并且
图8是可以由医疗装置或医疗装置***诸如关于图1-图5描述的说明性医疗装置和医疗装置***而实施的另一说明性方法的流程图。
虽然本公开适于各种修改和替代形式，但是其细节已经借由附图中的示例被示出并且将被详细描述。然而，应当理解，意图不是将本公开的方面限制于描述的特定说明性实施例。相反，意图是涵盖落入本公开的精神和范围内的所有修改、等同物和替代方案。
具体实施方式
应当参考其中将不同附图中的类似元件相同地编号的附图来阅读以下描述。本描述和不一定按比例的附图描绘说明性实施例，并不意图限制本公开的范围。
本公开描述了用于检测和安全地治疗心律失常的***、装置和方法。在包括多个医疗装置的一些医疗装置***中，该***的第一装置可以确定心律失常的发生，并且可以命令另一装置递送电刺激治疗。在这种***中，第一装置可以向第二装置传送命令，其中在接收到命令时，第二装置发起电刺激治疗的递送。在一些医疗装置***中，实施一个或多个保护措施以帮助确保第二医疗装置没有错误地递送电刺激治疗可能是重要的。本公开详细描述了各种示例保护技术。
图1是示例性无引线心脏起搏器(LCP)的概念图，其可以被植入患者，并且可以操作以感测生理信号和参数并将一种或多种类型的电刺激治疗递送到患者的组织。示例电刺激治疗包括抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)、心动过缓治疗和/或包括速率响应起搏治疗的各种类型的起搏治疗等。如在图1中可以看出的，LCP 100可以是具有容纳在LCP 100内或直接在外壳120上的所有组件的紧凑装置。说明性LCP 100可以包括通信模块102、脉冲发生器模块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中描绘的，LCP 100可以包括电极114，其可以相对于外壳120被固定，但暴露于LCP 100周围的组织和/或血液。电极114通常可以将电信号传导至LCP 100和周围的组织和/或血液以及从其传导电信号。这样的电信号可以包括通信脉冲、电刺激脉冲和固有心电信号。固有心电信号可以包括由心脏生成的电信号，并且可由心电图(ECG)来表示。电极114可以由一种或多种生物相容性导电材料制成，诸如已知为可安全地植入人体内的各种金属或合金。在一些情况下，电极114可以通常被布置在LCP 100的任一端上并且可以处于与模块102、104、106、108和110中的一个或多个电通信中。在其中电极114被直接固定到外壳120的实施例中，电极114可以具有将电极114与相邻电极、外壳120和/或LCP 100的其他部分电隔离的绝缘部分。电极114中的一些或全部可以与外壳120间隔开并且通过连接线被连接到LCP 100的外壳120和/或其他组件。在这样的实施例中，电极114可以被放置在从外壳120延伸的尾部上。如图1中示出的，在一些实施例中，LCP 100可另外包括电极114’。电极114’类似于电极114，除了电极114’被布置在LCP 100的侧面上并且增加LCP 100可以通过其递送通信脉冲和电刺激脉冲和/或感测固有心电信号、通信脉冲和/或电刺激脉冲的电极的数量之外。
电极114和/或114’可以具有各种尺寸和/或形状中的任何一种，并且可以以多种距离中的任何一种间隔开。例如，电极114可以具有二至二十毫米(mm)的直径。然而，在其他实施例中，电极114和/或114’可以具有二、三、五、七毫米(mm)的直径或任何其他合适的直径、尺寸和形状。电极114和/或114’的示例长度包括零、一、三、五、十毫米(mm)的长度或任何其他合适长度。如本文使用的，长度是远离外壳120延伸的电极114和/或114’的尺寸。另外，电极114和/或114’中的至少一些可以彼此间隔二十、三十、四十、五十毫米(mm)的距离或任何其他合适的距离。单个装置的电极114和/或114’可以相对于彼此具有不同的尺寸，并且装置上的电极的间隔可能不均匀。
通信模块102可以被电耦接到电极114和/或114’，并且被配置为向患者的组织递送通信脉冲，以与诸如传感器、编程器和其他医疗装置等的其他装置通信。如本文使用的，通信脉冲可以是由其本身或与一个或多个其他调制信号相结合地将信息传送到另一装置的任何调制信号。在一些实施例中，通信脉冲被限制为仅包括传送信息的亚阈值信号。这样的其他装置可以位于患者身体的外部或内部。通信模块102可以另外被配置为感测由位于LCP 100外部的其他装置递送的通信脉冲。不论位置如何，LCP和其他装置都可以经由通信模块102相互通信以完成一个或多个所期功能。一些示例功能包括存储传送的数据、使用传送的数据来确定心律失常的发生、协调电刺激治疗(诸如触发ATP治疗)的递送和/或其他功能。
LCP 100和其他装置可以使用递送的通信脉冲来传送原始信息、经处理的信息、消息和/或其他数据。原始信息可以包括诸如感测到的电信号(例如感测到的ECG)和从被耦接的传感器收集的信号等的信息。在一些实施例中，原始信息可以包括已经使用一个或多个信号处理技术来滤波的信号。经处理的信息可以包括由LCP 100确定出的任何信息。例如，经处理的信息可以包括确定出的心率、确定出的心跳的计时、其他确定出的事件的计时、阈值交叉点的确定、监视的时间段的到期以及诸如活动参数、血氧参数、血压参数和心音参数等的确定出的参数。消息可以包括指导另一装置采取动作的指令或命令、发送装置即将发生的动作的通知、从接收装置读取或向接收装置写入数据的请求。
在至少一些实施例中，通信模块102(或LCP 100)还可以包括切换电路以选择性地将电极114和/或114’中的一个或多个连接到通信模块102，以便选择通信模块102经由哪个电极114和/或114’递送通信脉冲。另外，通信模块102可以被配置为使用一种或多种方法来与其他装置进行通信。例如，通信模块102可以经由传导信号、射频(RF)信号、光信号、声信号、电感耦合和/或适于通信的任何其他信号或方法进行通信。
LCP 100的脉冲发生器模块104也可以被电连接到一个或多个电极114和/或114’。脉冲发生器模块104可以被配置为生成电刺激脉冲并且经由电极114和/或114’电极将电刺激脉冲递送到患者的组织，以便实现一个或多个电刺激治疗。如本文使用的电刺激脉冲意图包括可以被递送到患者组织以用于治疗任何类型的疾病或异常的目的的任何电信号。当被用于治疗心脏疾病或异常时，电刺激脉冲通常可被配置以便捕获患者的心脏，导致心脏响应于递送的电刺激脉冲而收缩。这些电刺激脉冲的一个示例包括起搏脉冲。在其中脉冲发生器104被配置为生成被称为除颤/心律转复脉冲的特定类型的电刺激脉冲的至少实施例中，脉冲发生器模块104可以包括一个或多个电容器元件或其他电荷存储装置。
脉冲发生器模块104可以包括诸如通过调整电刺激脉冲的脉冲宽度或幅度来修改电刺激脉冲的能力，以便确保递送的电刺激脉冲持续地捕获心脏。脉冲发生器模块104可以使用被存储在能量存储模块112中的能量来生成电刺激脉冲。在至少一些实施例中，脉冲发生器模块104(或LCP 100)还可以包括切换电路以选择性地将电极114和/或114’中的一个或多个连接到脉冲发生器模块104，以便选择脉冲发生器104经由哪些电极114和/或114’递送电刺激脉冲。
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可被配置为感测从电极114和/或114’传导至电感测模块106的固有心电信号。例如，电感测模块106可以被电连接到一个或多个电极114和/或114’，并且电感测模块106可以被配置为接收通过电极114和/或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其中植入LCP 100的腔室的局部信息。例如，如果LCP 100被植入心脏的心室内，则由LCP 100通过电极114和/或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可以包括或者被电连接到各种传感器，诸如加速度计、血压传感器、心音传感器、血氧传感器和/或测量心脏和/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可收集来自传感器的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都可以进一步被连接到处理模块110，并且可以向处理模块110提供表示感测到的心电信号和/或生理信号的信号。虽然关于图1被描述为分离的感测模块，但是在一些实施例中，电感测模块106和机械感测模块108可以被组合成单个模块。
处理模块110可以被配置为控制LCP 100的操作。例如，处理模块110可以被配置为从电感测模块106接收心电信号和/或从机械感测模块108接收生理信号。基于接收到的信号，处理模块110可以确定心律失常的发生和类型。处理模块110还可以从通信模块102接收信息。在一些实施例中，处理模块110可另外地使用这样接收到的信息来确定心律失常的发生和类型。然而，在其他实施例中，LCP 100可以使用接收到的信息而不是从电感测模块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已经被禁用或从LCP 100中省略的话。
基于任何确定出的心律失常，处理模块110然后可以控制脉冲发生器模块104根据一种或多种电刺激治疗来生成电刺激脉冲，以治疗确定出的心律失常。例如，处理模块110可以控制脉冲发生器模块104生成具有变化的参数和以不同序列的起搏脉冲，以实现一个或多个电刺激治疗。在控制脉冲发生器模块104递送心动过缓起搏治疗中，处理模块110可以控制脉冲发生器模块104以规则的间隔递送被设计为捕获患者心脏的起搏脉冲，以防患者的心脏降至预定阈值以下。针对ATP治疗，处理模块110可以控制脉冲发生器模块104以比患者的固有心率更快的速率递送起搏脉冲，以试图迫使心脏响应于递送的起搏脉冲而不是响应于固有的心电信号而跳动。处理模块110然后可以控制脉冲发生器模块104将递送的起搏脉冲的速率降低到安全等级。在CRT中，处理模块110可以控制脉冲发生器模块104与另一装置协调地递送起搏脉冲，以致使心脏更有效地收缩。另外地，在其中脉冲发生器模块104能够生成用于除颤/心律转复治疗的除颤和/或心律转复脉冲的情况下，处理模块110可以控制脉冲发生器模块104生成这种除颤和/或心律转复脉冲。在其他实施例中，处理模块110可以控制脉冲发生器模块104生成电刺激脉冲，以提供不同于本文描述的那些的电刺激治疗来治疗一个或多个检测到的心律失常。
除了控制脉冲发生器模块104生成不同类型并且以不同序列的电刺激脉冲，在一些实施例中，处理模块110还可以控制脉冲发生器模块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可以控制脉冲发生器模块104生成具有特定脉冲宽度和脉冲幅度的各种电刺激脉冲。例如，如果电刺激脉冲没有有效地捕获心脏，则处理模块110可以致使脉冲发生器模块104调整电刺激脉冲的脉冲宽度和/或脉冲幅度。对各种电刺激脉冲的特定参数的这种控制可以确保LCP 100能够提供电刺激治疗的有效递送。
在一些实施例中，处理模块110还可以控制通信模块102向其他装置发送信息。例如，处理模块110可以控制通信模块102生成用于与装置***的其他装置通信的一个或多个通信脉冲。例如，处理模块110可以控制通信模块102以特定序列生成通信脉冲，其中特定序列将不同的数据传送到其他装置。通信模块102还可以将任何接收到的通信信号传导至处理模块110以用于由处理模块110进行的潜在动作。
在进一步的实施例中，处理模块110可另外控制切换电路，通信模块102和脉冲发生器模块104通过该切换电路将通信脉冲和电刺激脉冲递送到患者的组织。如上面描述的，通信模块102和脉冲发生器模块104两者都可以包括用于将一个或多个电极114和/114’连接到通信模块102和脉冲发生器模块104的电路，所以这些模块可以将通信脉冲和电刺激脉冲递送到患者的组织。通信模块102和脉冲发生器模块104通过其递送通信脉冲和电刺激脉冲的一个或多个电极的特定组合影响了通信脉冲的接收和/或电刺激脉冲的有效性。虽然描述了通信模块102和脉冲发生器模块104中的每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、脉冲发生器模块104以及电极114和/或114’的全部的单个切换模块。在这种实施例中，处理模块110可以控制单个切换模块来连接模块102/104和电极114/114’。
在一些实施例中，处理模块110可以包括预编程芯片，诸如超大规模集成(VLSI)芯片或专用集成电路(ASIC)。在这样的实施例中，可以使用控制逻辑来对芯片进行预编程，以便控制LCP 100的操作。通过使用预编程芯片，处理模块110可以在能够保持基本功能的同时使用比其他可编程电路更少的电力，从而增加LCP 100的电池寿命。在其他实施例中，处理模块110可以包括可编程微处理器等。这种可编程微处理器可以允许用户在制造之后调整LCP 100的控制逻辑，从而允许LCP 100比在使用预编程芯片时更大的灵活性。
在另外的实施例中，处理模块110还可以包括存储器电路，并且处理模块110可以在存储器电路上存储信息和从存储器电路读取信息。在其他实施例中，LCP 100可以包括与处理模块110通信的分离的存储器电路(未示出)，使得处理模块110可以从分离的存储器电路读取信息和向其写入信息。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)可具有例如八位的地址长度。然而，在其他实施例中，存储器电路可具有十六、三十二或六十四位的地址长度或适合的任何其他位长度。另外，存储器电路可以是易失性存储器、非易失性存储器或易失性存储器和非易失性存储器的组合。
能量存储模块112可以向LCP 100提供电源以用于其操作。在一些实施例中，能量存储模块112可以是不可再充电的基于锂的电池。在其他实施例中，不可再充电电池可以由本领域已知的其他合适的材料制成。由于LCP 100是植入式装置，因此对LCP 100的访问可能被限制。在这种情况下，需要具有足够的能量容量以在延长的治疗时段(诸如数天、数周、数月或数年)内递送治疗。在一些实施例中，能量存储模块110可以是可再充电电池，以便促进增加LCP 100的可用寿命。在其他实施例中，能量存储模块112可以是其他类型的能量存储装置，诸如电容器。
为了将LCP 100植入患者体内，操作者(例如，医生、临床医生等)可将LCP 100固定到患者心脏的心脏组织。为了促进固定，LCP 100可以包括一个或多个锚定件116。锚定件116可以包括任何数量的固定或锚定机构。例如，锚定件116可以包括一个或多个销、卡钉、螺丝、螺钉、螺旋件和/或尖齿等。在一些实施例中，尽管未示出，但是锚定件116可在其外表面上包括可沿着锚定件116的至少一部分长度行进的螺纹。该螺纹可以提供心脏组织和锚定件之间的摩擦，以帮助将锚定件116固定在心脏组织内。在其他实施例中，锚定件116可以包括其他结构，诸如倒刺或长钉等，以促进与周围的心脏组织的啮合。
图2描绘了可以操作以感测生理信号和参数并将一种或多种类型的电刺激治疗递送到患者组织的另一装置、医疗装置(MD)200的实施例。在示出的实施例中，MD 200可以包括通信模块202、脉冲发生器模块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。模块202、204、206、208和210中的每个可以类似于LCP 100的模块102、104、106、108和110。另外，能量存储模块218可以类似于LCP 100的能量存储模块112。然而，在一些实施例中，MD 200可以在外壳220内具有较大的体积。在这种实施例中，MD 200可以包括能够处理比LCP 100的处理模块110更复杂的操作的更大的能量存储模块218和/或更大的处理模块210。
虽然MD 200可以是诸如图1中示出的另一无引线装置，但是在一些情况下，MD 200可以包括诸如引线212的引线。引线212可以包括在电极214和位于外壳220内的一个或多个模块之间传导电信号的电线。在一些情况下，引线212可以被连接到MD 200的外壳220并且远离该外壳220延伸。在一些实施例中，引线212被植入在患者的心脏上、内部或与其相邻。引线212可以包含一个或多个电极214，其被定位于引线212上的各个位置以及距外壳220各个距离处。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被定位于引线212上，使得当引线212被植入患者体内时，一个或多个电极214被定位以执行所期功能。在一些情况下，一个或多个电极214可以与患者的心脏组织接触。在其他情况下，一个或多个电极214可以皮下被定位但邻近患者的心脏。电极214可以将固有生成的心电信号传导到引线212。引线212继而可以将接收到的心电信号传导至MD 200的模块202、204、206和208中的一个或多个。在一些情况下，MD 200可以生成电刺激信号，并且引线212可以将生成的电刺激信号传导至电极214。电极214然后可以将电刺激信号传导至患者的心脏组织(直接或间接地)。MD 200还可以包括未被布置在引线212上的一个或多个电极214。例如，一个或多个电极214可以直接被连接到外壳220。
在一些实施例中，引线212可以另外地包含被配置为测量心脏和/或患者的一个或多个生理参数的一个或多个传感器，诸如加速度计、血压传感器、心音传感器、血氧传感器和/或其他传感器。在这样的实施例中，机械感测模块208可以处于与引线212电通信中，并且可以接收从这样的传感器生成的信号。
虽然不是必需的，但在一些实施例中，MD 200可以是植入式医疗装置。在这样的实施例中，MD 200的外壳220可以被植入例如患者的经胸腔区域中。外壳220通常可以包括对于在人体中的植入是安全的多种已知材料中的任一种，并且可以在被植入时针对患者身体的流体和组织而将MD 200的各种组件气密地密封。在这样的实施例中，引线212可以被植入在患者体内的一个或多个不同位置处，诸如患者的心脏内、邻近患者的心脏、邻近患者的脊柱或任何其他所期位置。
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可以具有被植入在患者心脏上或患者心脏内一个或多个引线，例如引线212。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可以被配置为感测固有地生成的心电信号，并且基于对感测到的信号的分析来确定例如一个或多个心律失常。MD 200可被配置为经由被植入心脏内的引线212递送CRT、ATP治疗、心动过缓治疗和/或其他治疗类型。在一些实施例中，MD 200可以另外地被配置为提供除颤/心律转复治疗。
在一些情况下，MD 200可以是植入式心律转复除颤器(ICD)。在这样的实施例中，MD 200可以包括被植入患者心脏内的一个或多个引线。MD 200还可以被配置为感测心电信号、基于感测到的心电信号来确定快速性心律失常的发生、并且响应于确定快速性心律失常的发生而递送除颤和/或心律转复治疗(例如通过将除颤和/或心律转复脉冲递送到患者的心脏)。在其他实施例中，MD 200可以是皮下植入式心律转复除颤器(SICD)。在其中MD200是SICD的实施例中，引线212之一可以是皮下植入的引线。在其中MD 200是SICD的至少一些实施例中，MD 200可以仅包括皮下植入但在胸腔外部的单个引线，然而这不是必需的。
在一些实施例中，MD 200可以不是植入式医疗装置。而是，MD 200可以是患者身体外部的装置，并且电极214可以是被放置在患者身体上的皮肤电极。在这样的实施例中，MD200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被植入患者体内的装置生成并通过身体传导至皮肤的电信号)。在这样的实施例中，MD 200可以被配置为递送各种类型的电刺激治疗，包括例如除颤治疗。
图3示出了医疗装置***和医疗装置***的多个医疗装置302、304、306和/或310可以通过其进行通信的通信路径的实施例。在示出的实施例中，医疗装置***300可以包括LCP 302和304、外部医疗装置306和其他传感器/装置310。外部装置306可以是被布置在患者身体外部的装置，如先前关于MD 200描述的。其他传感器/装置310可以是先前关于MD200描述的任何装置，诸如ICP、ICD和SICD。其他传感器/装置310还可以包括收集关于患者的信息的各种诊断传感器，诸如加速度计或血压传感器等。在一些情况下，其他传感器/装置310可以包括可以被用于对***300的一个或多个装置进行编程的外部编程器装置。
***300的各种装置可以经由通信路径308进行通信。例如，LCP 302和/或304可以感测固有的心电信号，并且可以经由通信路径308将这样的信号传送到***300的一个或多个其他装置302/304、306和310。在一个实施例中，装置302/304中的一个或多个可以接收这样的信号，并且基于接收到的信号来确定心律失常的发生。在一些情况下，一个或多个装置302/304可以将这样的确定传送到***300的一个或多个其他装置306和310。在一些情况下，***300的装置302/304、306和310中的一个或多个可以基于传送的心律失常的确定而采取动作，诸如通过将合适的电刺激递送到患者的心脏。***300的装置302/304、306和310中的一个或多个可以另外经由通信路径传送命令消息或响应消息。命令消息可以致使接收装置采取特定动作，而响应消息可以包括请求的信息或接收装置事实上接收到传送的消息或数据的确认。
可以设想的是，***300的各种装置可以使用RF信号、电感耦合、光信号、声信号或适合于通信的任何其他信号经由路径308进行通信。另外，在至少一些实施例中，***300的各种装置可以使用多种信号类型经由路径308进行通信。例如，其他传感器/装置310可以使用第一信号类型(例如RF通信)与外部装置306通信，但是使用第二信号类型(例如传导通信)与LCP 302/304通信。此外，在一些实施例中，可以限制装置之间的通信。例如，如上面描述的，在一些实施例中，LCP 302/304可以仅通过其他传感器/装置310与外部装置306通信，其中LCP 302/304向其他传感器/装置310发送信号，并且其他传感器/装置310将接收到的信号中继到外部装置306。
在一些情况下，***300的各种装置可以使用传导通信信号经由路径308进行通信。因此，***300的装置可以具有允许这种传导通信的组件。例如，***300的装置可以被配置为经由发送装置的一个或多个电极将传导通信信号(例如，电流和/或电压脉冲)发送到患者体内，并且可以经由接收装置的一个或多个电极接收传导通信信号(例如脉冲)。患者的身体可以将传导通信信号(例如脉冲)从发送装置的一个或多个电极“传导”至***300中的接收装置的电极。在这样的实施例中，递送的传导通信信号(例如脉冲)可能与起搏脉冲、除颤和/或心律转复脉冲或其他电刺激治疗信号不同。例如，***300的装置可以以是亚阈值的幅度/脉冲宽度递送电通信脉冲。也就是说，通信脉冲具有被设计为不捕获心脏的幅度/脉冲宽度。在一些情况下，递送的电通信脉冲的幅度/脉冲宽度可能高于心脏的捕获阈值，但是如果需要，则可以在心脏的不应期期间被递送和/或可以被并入起搏脉冲或被调制到起搏脉冲上。
递送的电通信脉冲可以以任何合适的方式进行调制以编码传送的信息。在一些情况下，通信脉冲可以是脉冲宽度调制和/或幅度调制的。可替代地或另外地，脉冲之间的时间可以被调制以编码所期信息。在一些情况下，预定义的通信脉冲序列可以表示对应的符号(例如逻辑“1”符号、逻辑“0”符号、ATP治疗触发符号等)。在一些情况下，传导通信脉冲可以是电压脉冲、电流脉冲、双相电压脉冲、双相电流脉冲、或根据需要的任何其他合适的电脉冲。
图4和图5示出了可以被配置为根据本文公开的技术进行操作的说明性医疗装置***。例如，该***可以包括被植入患者体内并且被配置为感测生理信号、确定心律失常的发生、并递送电刺激以治疗检测到的心律失常的多个装置。在图4中，示出了LCP 402被固定在心脏410的右心室的内部，并且示出了脉冲发生器406被耦接到具有一个或多个电极408a-408c的引线412。在一些情况下，脉冲发生器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可以皮下被定位于邻近心脏。LCP 402可以诸如经由通信路径308与SICD通信。图4中描绘的LCP 402、脉冲发生器406、引线412和电极408a-c的位置仅仅是示例性的。在***400的其他实施例中，LCP 402可以根据需要被定位于心脏的左心室、右心房或左心房中。在其他实施例中，LCP 402可以邻近于心脏410或甚至远离心脏410被外部地植入。
在图5中，示出了LCP 502被固定到心脏510的左心室的内部，并且示出了脉冲发生器506被耦接到具有一个或多个电极504a-504c的引线512。在一些情况下，脉冲发生器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可以被定位于心脏510中。在一些情况下，LCP 502可以诸如经由通信路径308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。如同图4，在图5中描绘的LCP 502、脉冲发生器506、引线512、电极504a-c的位置仅仅是示例性的。在***500的其他实施例中，LCP 502可以根据需要被定位于心脏的右心室、右心房或左心房。在其他实施例中，LCP 502可以邻近于心脏510或甚至远离心脏510被外部地植入。另外，在一些实施例中，引线512和/或电极504a-c可以被布置在心脏510的不同腔室中，或脉冲发生器可以包括被布置在心脏510内或邻近心脏510的另外的引线和/或电极。
医疗装置***400和500还可以包括诸如外部支持装置420和520的外部支持装置。外部支持装置420和520可以被用于执行诸如装置识别、装置编程和/或使用本文描述的一种或多种通信技术在装置之间传送实时数据和/或存储的数据的功能。作为一个示例，经由无线模式执行外部支持装置420与脉冲发生器406之间的通信，并且经由传导通信模式执行脉冲发生器406与LCP 402之间的通信。在一些实施例中，通过脉冲发生器406发送通信信息来实现LCP402和外部支持装置420之间的通信。然而，在其他实施例中，LCP 402和外部支持装置420之间的通信可以是经由通信模块的。
图4-图5仅示出了可以被配置为根据本文公开的技术操作的医疗装置***的几个实施例。其他示例医疗装置***可以包括另外或不同的医疗装置和/或配置。例如，适合于根据本文公开的技术操作的其他医疗装置***可以包括被植入心脏内的另外的LCP。另一个示例医疗装置***可以包括具有或不具有诸如脉冲发生器406或506的其他装置的多个LCP，其中至少一个LCP能够递送除颤治疗。又一示例可以包括与经静脉起搏器一起被植入的一个或多个LCP，并且具有或不具有植入的SICD。在其他实施例中，医疗装置、引线和/或电极的配置或放置可能与图4和图5中描绘的那些不同。因此，应当认识到，与图4和图5中描绘那些不同的许多其他医疗装置***可以根据本文公开的技术来操作。像这样，图4和图5中示出的实施例***不应该被视为以任何方式限制。
使用图4的***作为一个示例性实施例，可以包括脉冲发生器406的ICD(其可以是非皮下植入的装置、或皮下植入的装置(SICD))和LCP 402，可以确定心律失常的发生并协调安全地递送电刺激治疗。在一个实施例中，在ICD确定心律失常的发生(诸如快速性心律失常)之后，ICD可以向LCP 402传送命令以递送ATP治疗。
图6A-图6B描绘了表示ICD可以与LCP 402通信以命令LCP 402递送电刺激治疗的通信脉冲序列的示例电信号。在图6A-图6B的实施例中，通信脉冲可以具有预定义的幅度和脉冲宽度，并且可以以预定模式间隔开。例如，在图6A的实施例中，通信脉冲序列包括全部都具有公共幅度603和脉冲宽度605的四个独立通信脉冲601a-601d。通信脉冲601a和601b以时间延迟606彼此间隔开。类似地，通信脉冲601c和601d以时间延迟606彼此间隔开。脉冲601b和601c以更长的时间延迟607间隔开。这可以提供应该与可能在LCP 402的电极上呈现的噪声区分开的相对简单的通信脉冲模式。
图6B描绘了另一个实施例。在该实施例中，通信脉冲序列以单个脉冲601a开始，随后是时间延迟607之后的两个通信脉冲601b和601c。通信脉冲601b和601c以较短的时间延迟606间隔开。最后，通信脉冲601d与通信脉冲601c以时间延迟607间隔开。再次，这可以提供应该与可能在LCP 402的电极上呈现的噪声区分开的另一个相对简单的通信脉冲模式。
应当理解，图6A-图6B中描绘的示例通信脉冲序列仅仅是说明性的。在其他实施例中，脉冲幅度603和脉冲宽度605可以在独立通信脉冲601a-601d之间变化。在附加或替代实施例中，601a-601d之间的间隔可以不同于图6A-图6B中描绘的。在另外的实施例中，指示用于LCP 402递送ATP治疗的命令的通信脉冲序列中的通信脉冲的数量可以具有更多或更少的通信脉冲。在至少一些实施例中，通信脉冲序列可以不包括可能被用于将通信脉冲序列错误地检查为有效通信脉冲序列的任何错误检查信息(例如，奇偶校验位)，例如它来自ICD并且是用于LCP 402递送ATP治疗的有效命令。
在一些示例***中，ICD和LCP 402可以仅经由单向通信路径进行通信，由此ICD向LCP 402发送通信，但是LCP 402不将通信发送回ICD。在这样的实施例中，LCP 402可监听指示用于LCP 402递送ATP治疗的命令的预定通信脉冲序列，诸如图6A-图6B中示出的说明性通信脉冲序列。在接收到预定脉冲序列时，LCP 402可以递送ATP治疗。在采用从ICD到LCP402的单向通信和/或没有任何错误检查方案到位以帮助确保接收到的命令LCP 402递送ATP治疗的通信脉冲序列的有效性的***中，这可能有益于包括一个或多个保护特征，使得在ICD未实际命令时(例如由于噪声等)LCP 402不会错误地递送ATP治疗。当不需要治疗时，ATP治疗的递送在某些情况下可能对患者是有害的。
LCP 402可以提供的一个示例保护特征是触发的ATP治疗模式。例如，在接收到指示递送ATP治疗的命令的电信号之后，LCP 402可以检查其触发的ATP治疗模式是否被使能。如果触发的ATP治疗模式被使能，则LCP 402然后可以进行。如果触发的ATP治疗模式未被使能，则LCP 402可能不进行递送ATP治疗。通常，触发的ATP治疗模式可以包括其中LCP 402将响应于接收到指示递送ATP治疗的命令的电信号而递送ATP治疗的模式。在触发的ATP治疗模式的一些实施例中，当ATP治疗模式是活跃的时，LCP 402仍然可以响应于其它输入(例如感测到的心电信号)而递送ATP治疗。然而，在其他实施例中，当触发的ATP治疗模式是活跃的时，LCP 402可以仅响应于接收到指示递送ATP治疗的命令的电信号而递送ATP治疗。
触发的ATP治疗模式可以例如仅在LCP 402是医疗***的一部分时被使能，其中***中的其他装置之一被配置为向LCP 402传送命令以递送ATP治疗。由于通信脉冲序列的相对简单的性质，所以在一些情况下，LCP 402可以接收/解释复制或可以被解释为用于LCP402递送ATP治疗的命令的通信脉冲序列的噪声信号。在其中LCP 402不是***的一部分的实施例中(其中装置可以向LCP402传送递送ATP治疗的命令)，禁用LCP 402的触发的ATP治疗模式可以帮助防止LCP 402由于接收到的噪声信号而错误地递送ATP治疗。
这种触发的ATP治疗模式安全特征可以特别有用于其中LCP 402不与其他装置、或至少可以向LCP 402传送命令以递送ATP治疗的装置进行通信的情况下，这是因为LCP 402可能无法双重检查其他装置或确认收到命令。触发的ATP治疗模式也可以在其中没有错误检查方案来验证命令来自于另一有效医疗装置并且是有效命令的***中是有用的。然而，这样的安全特征在包括双向通信和/或错误检查方案的***中也可以是有用的。
在其它实施例中，除了触发的ATP治疗模式之外、或者作为触发的ATP治疗模式的替代，LCP 402可以包括心律失常阈值安全特征。例如，上面描述的***的ICD可以监视心率参数。当ICD检测到心率已经升高到等于或大于预定阈值时，ICD可以确定诸如心动过速的心律失常的发生。当发生这种情况时，ICD可以向LCP 402传送命令以递送ATP治疗。然而，在一些情况下，ICD可能错误地确定出心率高于预定阈值。例如，ICD可以对R波计数以确定心率。在某些情况下，ICD也可能将T波或P波作为R波错误地计数，从而错误地检测大于真实心率的心率。
在其中LCP 402包括心律失常阈值安全特征的这些实施例中，在接收到递送ATP治疗的命令之后，LCP 402可以基于其从心脏接收到的心脏信号来确定心率。在确定心率后，LCP 402可将其确定出的心率与心律失常阈值进行比较。如果确定出的心率大于或等于心律失常阈值，则LCP 402可以进行向患者的心脏递送ATP治疗。如果确定出的心率不大于或等于心律失常阈值，则LCP 402可能不进行向患者的心脏递送ATP治疗。这种心律失常阈值安全特征可能有助于防止由于通过ICD的心率检测错误而导致ATP治疗不必要地向患者递送。
当然，在一些示例***中，触发的ATP治疗模式和心律失常阈值安全特征都可以被实现以提供多层次的安全方法。例如，在接收到用于LCP 402递送ATP治疗的命令之后，LCP402可以检查触发的ATP治疗模式是否被使能。仅当LCP402确定出触发的ATP治疗模式被使能时，LCP 402才确定心率并将确定出的心率与心律失常阈值进行比较。如果LCP 402确定出心率等于或大于心律失常阈值，则可以允许LCP 402递送ATP治疗。
在其它实施例中，再次地除了触发的ATP治疗模式或心律失常阈值安全特征或者两者皆有之外，或者作为替代，一些***可以包括ATP治疗突发计数阈值安全特征。在这些实施例中，LCP 402可以跟踪已经作为ATP治疗递送的一部分被递送了的ATP治疗突发的数量。在接收到递送ATP治疗的命令之后，并且在递送ATP治疗之前，LCP 402可以将ATP治疗突发的数量与ATP治疗突发计数阈值进行比较。如果ATP治疗突发的数量小于ATP治疗突发计数阈值，则LCP 402可以进行递送ATP治疗。然而，如果ATP治疗突发的数量等于或超过ATP治疗突发计数阈值，则LCP 402可能不进行递送ATP治疗。
在一些实施例中，ATP治疗突发可以指递送的起搏脉冲的序列，并且LCP402可以在ATP治疗的单次递送期间递送多个ATP治疗突发。也就是说，LCP 402可以使用多个ATP治疗突发，以试图在被命令递送ATP治疗之后终止心律失常。然而，在其他实施例中，单个ATP治疗突发可以指由LCP 402进行的ATP治疗的单次递送，即使ATP治疗的单次递送包括递送起搏脉冲的多个序列或突发也是如此。
在包括ATP治疗突发计数阈值的一些实施例中，ATP治疗突发计数器可以与特定时间范围(time frame)有关。例如，ATP治疗突发计数阈值可以是在诸如一小时、两小时、十二小时、二十四小时或任何其他合适时间范围的时间范围内多个ATP治疗突发的递送的阈值。在递送第一ATP治疗突发时，LCP 402可以开始计时器并且递增ATP治疗突发计数器。在每个随后的ATP治疗突发的递送时，LCP 402可以递增ATP治疗突发计数器，并将ATP治疗突发计数器的值与ATP治疗突发计数阈值进行比较。如果ATP治疗突发计数器的值等于或超过ATP治疗突发计数阈值，则LCP 402可能不会递送ATP治疗。当计时器到达预定时间范围的结束时，LCP 402可以将ATP治疗突发计数器和计时器两者复位回零。计时器可以在复位时或ATP治疗突发的下次递送时再次开始运行。作为一个说明性实施例，ATP治疗突发计数阈值可以具有十个ATP治疗突发的值，并且计时器可以具有二十四小时的复位时间段。在该实施例中，如果LCP 402确定出计时器在二十小时，并且ATP治疗突发计数器处于十，则LCP 402可以确定ATP治疗突发的数量等于或超过ATP治疗突发计数阈值。在这样的实施例中，LCP 402可能不能递送ATP治疗。在计时器达到二十四小时后，LCP 402可以复位计时器和ATP治疗突发计数器。
应当理解，使用十个ATP治疗突发作为ATP治疗突发计数阈值的值，并且二十四小时的时间范围仅仅是一个实施例。ATP治疗突发计数阈值可以针对任何时间范围具有任何合适的值。另外，在其他实施例中，代替基于何时递送ATP治疗来保持运行计时器，LCP 402可以基于一天中的时间来跟踪ATP治疗突发的数量。例如，如果时间范围是小时计，则LCP402可以在每小时开始时(或在每次经过一个小时的时间之后)复位ATP治疗突发计数器。
在其中LCP 402能够进行双向通信的实施例中，在确定出ATP治疗突发计数器超过针对所分配的时间范围的ATP治疗突发计数阈值之后，LCP 402可以传送错误消息。该错误消息可以被传送到***的用户(通过由病人外部的装置直接接收或通过ICD中继)，并且该用户可以采取适当的动作。
在至少一些实施例中，ICD可以跟踪被发送给LCP 402以递送ATP治疗的命令的数量以及由LCP 402递送的ATP治疗的数量。ICD可以另外将传送的命令的跟踪数量与递送的ATP治疗的数量进行比较。如果ICD确定出两个值之间的差异等于或大于阈值，则ICD可以将错误消息传送到另一装置和/或采取其他动作。
当然，ATP治疗突发计数阈值安全特征可以与触发的ATP治疗模式安全特征或心律失常阈值安全特征或两者结合，以提供多层安全特征。例如，当与触发的ATP治疗模式配对时，在接收到用于LCP 402递送ATP治疗的命令之后，LCP 402可以首先检查触发的ATP治疗模式是否被使能。只有当LCP 402确定出触发的ATP治疗模式被使能时，LCP 402才增加ATP治疗突发计数器，并将ATP治疗突发计数器与ATP治疗突发计数阈值进行比较。如果LCP 402确定出ATP治疗突发计数器小于ATP治疗突发计数阈值，则允许LCP 402进行递送ATP治疗。可替代地，ATP治疗突发计数阈值安全特征可以与心律失常阈值安全特征配对。在这样的实施例中，在接收到递送ATP治疗的命令之后，LCP 402可以确定心率并将确定出的心率与心律失常阈值进行比较。如果LCP 402确定出心率等于或大于心律失常阈值，则可允许LCP402进行增加ATP治疗突发计数器。在增加ATP治疗突发计数器之后，LCP 402可以将ATP治疗突发计数器与ATP治疗突发计数阈值进行比较。如果LCP 402确定出ATP治疗突发计数器小于ATP治疗突发计数阈值，则可允许LCP 402进行递送ATP治疗。
在其它实施例中，所有三个触发的ATP治疗模式安全特征、心律失常阈值安全特征和ATP治疗突发计数阈值安全特征可以以多层次方式组合。在图7的流程图中示出了如何组合安全特征的一个实施例。图7中的流程图示出了可以在递送ATP治疗之前由LCP 402实施的示例方法700。流程图700在步骤702处开始，其中LCP 402接收到递送ATP治疗的命令。在框704处，LCP 402可以确定其触发的ATP治疗模式是否被使能。
如果LCP 402确定出触发的ATP治疗模式未被使能，则LCP 402可以在不执行ATP治疗的情况下退出流程图，如706处示出的。然而，如果LCP 402确定出触发的ATP治疗模式被使能，则LCP 402可以继续确定心率，如708处示出的。在确定心率之后，LCP 402可以确定心率是否等于或大于心律失常阈值，如710处示出的。如果LCP 402确定出心率小于心律失常阈值，则LCP 402可以在不执行ATP治疗的情况下退出流程图，如706处示出的。
如果LCP 402确定出心率等于或大于心律失常阈值，则LCP 402可以进行确定ATP治疗突发计数器是否等于或大于ATP治疗突发计数阈值，如712处示出的。如果LCP 402确定出ATP治疗突发计数器等于或大于ATP治疗突发计数阈值，则LCP 402可以在不执行ATP治疗的情况下退出流程图，如706处示出的。然而，如果LCP 402确定出ATP治疗突发计数器小于ATP治疗突发计数阈值，则LCP 402可以进行递送ATP治疗突发，如714处示出的。LCP 402可以另外递增ATP治疗突发计数器，如716处示出的。尽管块716在块714之后被描绘，但是在其他实施例中，框716可以在框714之前发生，或者以基本上同时的方式发生。在递送ATP治疗之后，LCP 402可以退出流程图，如706处示出的。
当然，在其他实施例中，可以以不同的顺序执行图7中详细描述的具体框。例如，LCP 402可以在确定心率之前确定ATP治疗突发计数器是否等于或超过ATP治疗突发计数阈值以及心率是否等于或大于心律失常阈值。在一些实施例中，除了ATP治疗突发计数器之外，LCP 402还可以增加治疗请求计数器。在其中ICD还跟踪其发送到LCP 402的递送ATP治疗的命令的数量的实施例中，该治疗请求计数器可用于确定LCP 402是否正在接收执行ATP治疗的错误命令。
在一些实施例中，在递送ATP治疗之后，LCP 402可以等待冲击并进入休克后起搏模式。在休克后起搏模式中，LCP 402可以向患者的心脏递送起搏脉冲。通常，LCP 402可以以比在递送的ATP治疗突发期间更慢的速率递送起搏脉冲。然而，LCP 402可以以比在处于正常起搏模式中时更高的速率递送起搏脉冲，但是这不是必需的。另外，在一些实施例中，当LCP 402处于休克后起搏模式中时递送的起搏脉冲的脉冲幅度可能大于当不处于休克后起搏模式中时(例如当LCP 402处于正常起搏模式中时)由LCP 402递送的起搏脉冲的脉冲幅度。在甚至其他实施例中，当LCP 402处于休克后起搏模式中时递送的起搏脉冲的脉冲宽度可能大于当不处于休克后起搏模式中时由LCP 402递送的起搏脉冲的脉冲宽度。当然，在其他实施例中，相对于正常起搏模式，可以提高递送的起搏脉冲的脉冲幅度和脉冲宽度两者。在各种实施例中，在递送ATP治疗之后，LCP 402可以在约三十至六十秒之间或任何其它合适的时间段内保持在休克后起搏模式中。在退出休克后起搏模式之后，LCP 402可以恢复到正常起搏模式。
图8是说明性LCP 402的说明性休克后起搏模式800的流程图。在一些实施例中，休克后起搏模式800可以是流程图700的分支。例如，在LCP 402递送ATP治疗之后，而不是在706处退出流程图，图7的分支718可以流入休克后起搏模式800的步骤802中。当这样提供时，在递送ATP治疗之后，LCP 402可以确定LCP 402的休克后起搏模式是否被使能，如在802处示出的。在一些实施例中，接收到的用于递送ATP治疗的命令还可以包括使能或禁用休克后起搏模式的指令。在这样的实施例中，ICD可能仅需要向LCP 402发送单个通信，以命令LCP 402递送ATP治疗，并且指示在递送ATP治疗之后LCP 402应进入或不进入休克后起搏模式。在其他实施例中，是否使能休克后起搏模式可以是可编程参数，如随后将讨论的。如果LCP 402确定出休克后起搏模式被禁用，则LCP 402可以退出流程图，如812处示出的。
然而，如果LCP 402确定出使能休克后起搏模式，则LCP 402可以加载休克后起搏模式参数，如804处示出的。在一些实施例中，休克后起搏模式参数包括起搏脉冲幅度。在其他实施例中，休克后起搏模式参数包括起搏脉冲宽度。在其他实施例中，休克后起搏模式参数包括在处于休克后起搏模式时要被递送的起搏脉冲的起搏速率。当然，在其他实施例中，休克后起搏模式参数可以包括这些参数的任何组合。休克后起搏模式参数可以被预编程到LCP 402的存储器中。尽管在其他实施例中，从ICD到LCP 402的递送ATP治疗的命令可以包括一个或多个休克后起搏模式参数。
在加载休克后起搏模式参数之后，LCP 402可以初始化休克后起搏模式计时器，如806处。LCP 402然后可以进入循环808以确定休克后起搏模式计时器何时已经达到休克后起搏模式计时器最大值，其对应于LCP 402处于休克后起搏模式中的时间长度。在确定出休克后起搏模式计时器已经达到其最大值之后，LCP 402加载正常起搏模式参数并返回到正常起搏模式，如810处示出的，并在812处退出流程图。
在一些额外的或替代实施例中，LCP 402和ICD的***可以包括区分不同类型的心律失常的能力。例如，ICD可以具有被存储在存储器中的一个或多个正常跳动模板。在确定心律失常的潜在发生之后，例如通过将确定出的心率与心率阈值进行比较，ICD可以将当前跳动的QRS波群与感测到的心电信号隔离开来。然后，ICD可以将当前跳动的QRS与正常跳动模板进行比较。例如，ICD可以执行当前跳动和正常跳动模板之间的相关分析。如果跳动之间的相关性等于或大于第一相关阈值，则ICD可以确定出没有发生心律失常。
然而，如果跳动之间的相关性小于第一相关阈值，则ICD可以进一步将QRS波群与先前跳动隔离开(或捕获新的当前跳动，并使用其与正常跳动模板相比较的跳动作为先前跳动)。然后，ICD可以将当前跳动与先前的跳动进行比较。例如，ICD可以在两个跳动之间执行相关分析。如果ICD确定出两个跳动之间的相关性等于或大于第二相关阈值，则ICD可以确定出心律失常是单形性室性心动过速(MVT)。如果ICD确定出两个跳动之间的相关性小于第二相关阈值，则ICD可以进一步将当前跳动的QRS波群的宽度与正常跳动模板的QRS波群的宽度进行比较。如果当前跳动的QRS波群的宽度比正常跳动模板的QRS波群更窄，则ICD可以确定出心律失常是室上性心动过速(SVT)。如果当前跳动的QRS波群的宽度比正常跳动模板的QRS波群更宽，则ICD可以确定出心律失常是多形性室性心动过速(PVT)。
在其中ICD能够确定一种类型的心动过速的情况下，ICD可以与LCP 402进行通信以递送不同的电刺激治疗。例如，在一些实施例中，如果ICD确定出心律失常的类型是PVT或SVT，则ICD可能不向LCP 402传送命令以递送ATP治疗。相反，ICD可以向心脏递送除颤和/或心律转复治疗以治疗心律失常。如果ICD确定出心律失常的类型是MVT，则ICD可以向LCP402传送命令以递送ATP治疗。然而，在其他实施例中，如果ICD确定出心律失常是SVT和/或PVT，则ICD可以向LCP 402传送命令。
在其他实施例中，ICD可以基于确定出的心律失常的类型来与LCP 402协调电刺激治疗的递送。例如，如果确定出的心律失常类型是MVT，则ICD可以向LCP 402传送命令以递送ATP治疗，但是可能不开始对其电荷存储装置充电以用于除颤和/或心律转复治疗的递送。相反，ICD可以在由LCP 402递送的ATP治疗期间和之后监视接收到的心电信号。ICD可以基于接收到的心电信号来确定递送的ATP治疗是否已经终止心律失常。如果ICD确定出ATP治疗没有终止心律失常，则ICD可能开始对电荷存储装置充电，并且一旦电荷存储装置被充电，就递送除颤和/或心律转复治疗。
在其中ICD确定出心律失常的类型是PVT或SVT的情况下，ICD仍然可以向LCP 402发送命令以递送ATP治疗。然而，随着发送命令，ICD还可以对其电荷存储装置充电以用于除颤和/或心律转复治疗的递送。ICD还可以在对其电荷存储装置充电时以及在LCP 402递送ATP治疗期间和之后监视接收到的心电信号。如果ICD确定出ATP治疗成功地终止了心律失常，则ICD可能会停止对其电荷存储装置充电，并且可能不递送除颤和/或心律转复治疗。然而，如果ICD确定出ATP治疗没有终止心律失常，则ICD可以完成对其电荷存储装置的充电并递送除颤和/或心律转复治疗。在这些实施例中，ICD可以通过在检测到某些类型的心律失常的心律失常时发起充电来保持电池寿命。当然，在其他实施例中，如果确定出的心律失常类型也是MVT和/或SVT，则ICD可等待发起充电。在其他实施例中，当确定出的心律失常类型是MVT时，ICD可以发起充电。
另外或替代地，在其中ICD可以区分各种心律失常类型的实施例中，ICD还可以将不同的ATP治疗参数传送给LCP 402。如上面讨论的，ICD可以在递送ATP治疗的命令中包括ATP治疗参数。因此，如果ICD确定出心律失常的类型是MVT，则ICD可以传送与ICD将传送的参数不同的ATP治疗参数(如果确定心律失常的类型是PVT和/或SVT的话)。
在一些实施例中，LCP 402可以在存储器中存储与不同心律失常类型相关联的不同ATP治疗参数。在这样的实施例中，代替ICD传送特定的ATP治疗参数，ICD可以仅传送确定类型的心律失常。在其他实施例中，LCP 402可以能够区分不同的心律失常类型。在这样的实施例中，代替ICD传送ATP治疗参数或心律失常的类型，LCP 402可以确定心律失常的类型并使用存储在其存储器中的与该类型的心律失常相关联的ATP治疗参数。
如关于图4和图5讨论的，可以实施这些公开技术的***在某些时候可以与外部支持装置(诸如外部支持装置420和520)通信。当外部支持装置处于与实施一个或多个公开技术的医疗装置***、诸如图4的***通信中时，用户可以与外部支持装置交互以对装置的各种特征进行编程。例如，用户可以与外部支持装置交互以使能或禁用LCP 402的触发的ATP治疗模式。用户可以设置或调整以下值：心律失常阈值、ATP治疗突发计数阈值、与ATP治疗突发计数阈值相关联的时间范围、各种ATP治疗参数、ATP治疗参数与心律失常类型之间的关联、休克后起搏模式计时器的长度以及本文讨论的其他各种参数。
另外，虽然关于包括LCP和ICD(再次，其可以是非皮下植入的装置或皮下植入的装置，例如SICD)的***描述了许多上面描述的技术，但是公开的技术可以在各种其他***中被实施。例如，许多公开的技术被描述为由LCP 402实施。在其他***中，提供电刺激治疗和接收命令以递送电刺激治疗的其它装置可以实施公开的技术中的一个或多个，例如ICD或SICD或心脏起搏器，其接收来自另一装置的命令以递送电刺激治疗。在包括多于两个装置的***中，***的两个或更多个装置可以独立地实施一个或多个公开的技术。例如，一些***可以包括多个LCP。在这样的***中，每个LCP可以在递送ATP治疗之前独立地执行一个或多个公开的技术。
此外，公开的技术也不应被视为仅限于ATP治疗。在其他实施例中，医疗装置***可以操作以提供其他类型的电刺激治疗。这样的***还可以实施一个或多个公开的技术(除了在递送ATP治疗之前执行一个或多个公开的技术之外)，在递送其它电刺激治疗(诸如CRT、除颤和/或心律转复治疗、心动过缓治疗和其他类型的电刺激治疗)之前，该装置可以执行一个或多个公开的技术。
通常，本领域的技术人员将认识到除在本文中描述和设想的具体实施例之外可以以各种形式来表明本公开。例如，如本文描述的，各种实施例包括被描述为执行各种功能的一个或多个模块。然而，其他实施例可以包括将描述的功能拆分在比本文描述的更多模块上的附加模块。另外，其他实施例可以将描述的功能合并成较少的模块。因此，在不脱离如在所附权利要求中描述的本公开的范围和精神的情况下，可以进行形式和细节上的偏离。

Claims (15)

1.一种无引线心脏起搏器(LCP)，包括：
外壳；
多个电极，其用于感测从所述外壳外部发出的电信号；
能量存储模块，其被布置在所述外壳内；
控制模块，其被布置在所述外壳内并且可操作地耦接到所述多个电极，其中所述控制模块被配置为：
经由所述多个电极中的两个或更多个接收电信号；
确定接收到的电信号是否指示用于所述LCP递送抗快速性心律失常起搏(ATP)治疗的命令；
如果所述接收到的电信号指示用于所述LCP递送抗快速性心律失常起搏(ATP)治疗的命令，则确定所述LCP的触发的ATP治疗模式是否被使能；
如果所述触发的ATP治疗模式被使能，则经由所述多个电极中的两个或更多个递送ATP治疗。
2.根据权利要求1所述的LCP，其中如果所述触发的ATP治疗模式被使能，则所述控制模块还被配置为响应于所述命令来确定是否递送ATP治疗，并且如果确定递送ATP治疗，则经由所述多个电极中的两个或更多个递送ATP治疗。
3.根据权利要求1-2中任一项所述的LCP，其中所述控制模块被配置为：如果所述触发的ATP治疗模式被使能，则确定递送ATP治疗。
4.根据权利要求1-3中任一项所述的LCP，其中，如果从所述接收到的电信号确定出的心率高于心律失常阈值，则所述控制模块被配置为确定递送ATP治疗。
5.根据权利要求1-4中任一项所述的LCP，其中所述控制模块被配置为保持已作为递送的ATP治疗的一部分被递送的ATP治疗突发的数量的计数，并且其中所述控制器模块还被配置为：如果ATP治疗突发的数量没有超过ATP治疗突发计数阈值，则确定递送ATP治疗。
6.根据权利要求5所述的LCP，其中，如果所述ATP治疗突发的数量已经超过所述ATP治疗突发计数阈值，则所述控制模块还被配置为将错误信号传送到另一个医疗装置。
7.根据权利要求1-6中任一项所述的LCP，其中所述控制模块被配置为确定经由所述多个电极中的两个或更多个接收到的心脏信号的信号形态类型，并且其中所述控制器模块还被配置为：如果确定出的信号形态类型是预定信号形态类型，则确定递送ATP治疗。
8.根据权利要求7所述的LCP，其中所述预定信号形态类型包括单形性室性心动过速(MVT)。
9.根据权利要求7所述的LCP，其中所述预定信号形态类型包括多形性室性心动过速(PVT)。
10.根据权利要求7所述的LCP，其中所述预定信号形态类型包括室上性心动过速(SVT)。
11.根据权利要求1-10中任一项所述的LCP，其中指示用于所述LCP递送抗快速性心律失常起搏(ATP)治疗的命令的信号包括由远程医疗装置产生的多个通信脉冲。
12.根据权利要求1-10中任一项所述的LCP，其中指示用于所述LCP递送抗快速性心律失常起搏(ATP)治疗的命令的信号包括来自远程医疗装置的作为单向通信路径的一部分的多个通信脉冲。
13.根据权利要求12所述的LCP，其中所述多个通信脉冲没有用于错误检查所述单向通信路径的错误检查信息。
14.根据权利要求1-13中任一项所述的LCP，其中所述控制模块还被配置为：在经由所述多个电极中的两个或更多个电极递送ATP治疗之后，递送休克后起搏治疗。
15.根据权利要求14所述的LCP，其中所述控制模块被配置为：在递送ATP治疗之后约30-60秒之间递送休克后打包治疗。
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US10220213B2 (en) 2019-03-05
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