CN109952129B - 为心脏起搏设备设定心脏起搏脉冲参数的系统、设备和方法 - Google Patents

为心脏起搏设备设定心脏起搏脉冲参数的系统、设备和方法 Download PDF

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CN109952129B
CN109952129B CN201780069404.8A CN201780069404A CN109952129B CN 109952129 B CN109952129 B CN 109952129B CN 201780069404 A CN201780069404 A CN 201780069404A CN 109952129 B CN109952129 B CN 109952129B
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pacing
lcp
pulse
amplitude
capture
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CN109952129A (zh
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兰斯·埃里克·朱费尔
威廉姆·J·林德
罗恩·A·鲍尔泽斯基
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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/371—Capture, i.e. successful stimulation
    • A61N1/3712—Auto-capture, i.e. automatic adjustment of the stimulation threshold
    • 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
    • A61N1/371—Capture, i.e. successful stimulation
    • 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
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37247—User interfaces, e.g. input or presentation means
    • 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
    • A61N1/37512—Pacemakers
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/378—Electrical supply
    • 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
    • A61N1/3706—Pacemaker parameters
    • A61N1/3708—Pacemaker parameters for power depletion

Abstract

公开了用于对患者心脏进行起搏的系统、设备和方法。设备可以包括无引线心脏起搏器(LCP)，其包括电源、电极对、以及可操作地连接到电极和电源的控制器。控制器可以通过将起搏幅度设定在电源的电源电压处来识别捕获阈值，并且递送具有不同脉冲宽度的起搏刺激脉冲以识别捕获阈值。然后，LCP可以至少部分地基于与捕获阈值相关联的脉冲幅度和脉冲宽度并且还添加捕获裕度来递送起搏刺激脉冲。在一些情况下，脉冲幅度可以随时间改变，并且LCP可以沿着强度‑持续时间曲线调节脉冲宽度以考虑脉冲幅度变化并保持捕获阈值和捕获裕度。

Description

为心脏起搏设备设定心脏起搏脉冲参数的系统、设备和方法
相关申请的交叉引用
本申请要求于2016年11月9日提交的美国临时专利申请序列号62/419,731的权益，其公开通过引用并入于此。
技术领域
本公开总体上涉及心脏起搏设备，并且更具体地涉及用于为这种心脏起搏设备设定起搏脉冲参数的系统、设备和方法。
背景技术
起搏仪器可以用于治疗患有各种心脏病的患者，心脏病导致心脏向患者身体递送足够量血液的能力降低。这些心脏病可能导致快速、不规则和/或低效的心脏收缩。为了帮助减轻这些病中的一些，可以将各种设备(例如，起搏器、除颤器等)植入患者体内。这种设备可监视并向心脏提供电刺激，以帮助心脏以更正常、高效和/或安全的方式工作。期望的是用于为这种设备设定起搏脉冲参数的经改进的系统、设备和方法。
发明内容
本公开总体上涉及心脏起搏设备，并且更具体地涉及用于为这种心脏起搏设备设定起搏脉冲参数的系统、设备和方法。
在说明性实施例中，心脏起搏设备可以包括无引线心脏起搏器(LCP)。无引线心脏起搏器可以被配置为被植入在患者的心脏中或患者的心脏上，并且可以将起搏脉冲递送到患者的心脏。虽然无引线心脏起搏器在本公开中用作示例，但是预期的是本文所公开的概念可以应用于被配置为将心脏起搏脉冲递送到患者的心脏的任何合适的心脏起搏设备。
说明性无引线心脏起搏器可以包括：用于提供电源电压的电源、用于将起搏脉冲递送到患者心脏的电极对、以及可操作地连接到电极对和电源的控制器。控制器可以识别捕获阈值并经由电极对递送多个起搏脉冲，每个起搏脉冲都具有起搏幅度和起搏脉冲宽度。控制器可以通过以下来识别捕获阈值：将起搏幅度设定为电源电压，并然后经由电极对递送具有起搏幅度和不同脉冲宽度的多个起搏脉冲，以识别对应于心脏的捕获阈值的捕获脉冲宽度。一旦已经识别出捕获脉冲宽度，控制器就可以经由电极对递送以下多个起搏脉冲，其具有所述起搏幅度和比捕获脉冲宽度大脉冲宽度裕度(margin)的起搏脉冲宽度。通过将起搏幅度设定为电源电压(例如电池电压)，在将电源电压转换为起搏幅度时浪费很少或没有电源能量(例如电池能量)。在一些情况下，这可以显著增加无引线心脏起搏器的使用预期寿命。
另外地或可替代地，对于第一说明性实施例，电源可以包括电池，并且电源电压可以包括由电池提供的电池电压。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，电池电压以及因此的起搏幅度可以随时间衰减。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，控制器可以被配置为不时地识别捕获阈值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，控制器可以存储表示一个或多个强度-持续时间曲线的数据，并且控制器可以被配置为至少部分地基于起搏幅度和捕获脉冲宽度来识别捕获阈值强度-持续时间曲线，并且控制器还可以被配置为通过参考所述起搏幅度以及强度-持续时间曲线中的不同一个来识别脉冲宽度裕度。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，其中如果电源电压改变，并且因此起搏幅度改变，则控制器可以被配置为：至少部分地基于改变的起搏幅度和强度-持续时间曲线中的不同一个来自动调节起搏脉冲宽度，而不必经由电极对递送具有改变的起搏幅度和不同脉冲宽度的多个起搏脉冲来更新捕获阈值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，控制器可以被配置为从远程设备接收表示一个或多个强度-持续时间曲线的数据。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，控制器还可以被配置为接收用户可选择功率效率值，并且其中脉冲宽度裕度可以至少部分地基于用户可选择功率效率值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，可以从远程设备接收用户可选择功率效率值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，远程设备可以包括用户界面，其包括显示部，其中用户可以使用用户界面来选择用户可选择功率效率值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，用户界面可以显示滑块，该滑块允许用户从可允许的用户可选择功率效率值的范围中选择用户可选择功率效率值。
另外地或可替代地，在关于第一说明性实施例的任何上述实施例中，用户界面可以显示至少部分地基于用户可选择功率效率值的无引线心脏起搏器的预期寿命的动态指示符。
在第二说明性实施例中，一种用于将起搏脉冲递送到患者心脏的无引线心脏起搏器系统可以包括远程设备和与远程设备通信的无引线心脏起搏器。远程设备可以具有用户界面，其具有用于接收对用户可选择功率效率值的选择的显示部。无引线心脏起搏器可以包括：用于提供电源电压的电源、用于将起搏脉冲递送到患者心脏的电极对、以及可操作地连接到电极对和电源的控制器。控制器识别对应于捕获阈值的脉冲宽度和脉冲幅度组合。控制器还可以从远程设备接收用户可选择功率效率值，并且可以将捕获裕度应用于对应于捕获阈值的脉冲宽度和脉冲幅度中的一个或多个，从而产生起搏脉冲宽度和起搏脉冲幅度。捕获裕度可以至少部分地基于用户可选择功率效率值。然后，控制器可以使用起搏脉冲宽度和起搏脉冲幅度将起搏脉冲递送到心脏。
另外地或可替代地，第二说明性实施例还可以包括被配置为存储表示一个或多个强度-持续时间曲线的数据的控制器，并且其中控制器可以被配置为通过将用户可选择功率效率值索引(index)到表示一个或多个强度-持续时间曲线的数据来识别捕获裕度。
另外地或可替代地，对于关于第二说明性实施例的任何上述实施例，其中远程设备在显示部上显示了：滑块，该滑块允许用户从可允许的用户可选择功率效率值的范围中选择用户可选择功率效率值；以及至少部分地基于用户可选择功率效率值的无引线心脏起搏器的预期寿命的动态指示符。
在第三说明性实施例中，一种用于将起搏脉冲递送到患者心脏的无引线心脏起搏器(LCP)可以包括：用于将起搏脉冲递送到患者心脏的电极对以及可操作地连接到电极对的控制器。控制器可以通过以下来识别捕获阈值：经由电极对递送多个起搏脉冲同时改变第一起搏脉冲参数值而同时使第二起搏脉冲参数值固定，以便识别用于第一起搏脉冲参数的捕获值。此外，控制器可以经由电极对递送以下多个起搏脉冲，其每个具有捕获值处的第一起搏脉冲参数值和高于固定的第二起搏脉冲参数值的捕获裕度处的第二起搏脉冲参数值。
另外地或可替代地，第三说明性实施例还可以包括其中第一起搏脉冲参数是脉冲宽度并且第二起搏脉冲参数是脉冲幅度。
另外地或可替代地，对于关于第三说明性实施例的任何上述实施例，无引线心脏起搏器还可以包括提供电池电压的电池，并且其中固定的第二起搏脉冲参数值可以是电池电压的预定分数。
另外地或可替代地，对于关于第三说明性实施例的任何上述实施例，高于固定的第二起搏脉冲参数值的捕获裕度处的第二起搏脉冲参数值可以对应于电池电压。
另外地或可替代地，对于关于第三说明性实施例的任何上述实施例，第一起搏脉冲参数可以是脉冲幅度，并且第二起搏脉冲参数可以是脉冲宽度。
另外地或可替代地，对于关于第三说明性实施例的任何上述实施例，控制器可以存储表示一个或多个强度-持续时间曲线的数据，并且控制器可以被配置为至少部分地基于一个或多个强度-持续时间曲线来识别捕获裕度。
在第四说明性实施例中，一种用于将起搏脉冲递送到患者心脏的无引线心脏起搏器(LCP)可以包括：用于将起搏脉冲递送到患者心脏的电极对以及可操作地连接到电极对的控制器。控制器识别对应于捕获阈值的脉冲宽度和脉冲幅度组合。控制器还可以从远程设备接收用户可选择功率效率值。控制器可以将捕获裕度应用于对应于捕获阈值的脉冲宽度和脉冲幅度中的一个或多个，从而产生起搏脉冲宽度和起搏脉冲幅度。捕获裕度可以至少部分地基于用户可选择功率效率值。然后，控制器可以使用起搏脉冲宽度和起搏脉冲幅度来递送起搏脉冲。
另外地或可替代地，第四说明性实施例还可以包括被配置为存储表示一个或多个强度-持续时间曲线的数据的控制器，并且其中控制器可以被配置为通过将用户可选择功率效率值索引到表示一个或多个强度-持续时间曲线的数据来识别捕获裕度。
另外地或可替代地，对于关于第四说明性实施例的任何上述实施例，控制器可以被配置为从远程设备接收表示一个或多个强度-持续时间曲线的数据。
另外地或可替代地，对于关于第四说明性实施例的任何上述实施例，远程设备可以包括用户界面，其包括显示部，其中用户可以使用用户界面来选择用户可选择功率效率值。
另外地或可替代地，对于关于第四说明性实施例的任何上述实施例，远程设备可以在显示部上显示滑块，其允许用户从可允许的用户可选择功率效率值的范围中选择用户可选择功率效率值。
另外地或可替代地，对于关于第四说明性实施例的任何上述实施例，远程设备可以显示至少部分地基于用户可选择功率效率值的无引线心脏起搏器的预期寿命的动态指示符。
另外地或可替代地，对于关于第四说明性实施例的任何上述实施例，无引线心脏起搏器还可以包括用于提供电池电压的电池，并且其中起搏脉冲幅度被设定为电池电压。
以上概述不旨在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其更全面的理解将变得显而易见并被领会。
附图说明
考虑到结合附图的各种说明性实施例的以下描述，可以更全面地理解本公开，其中：
图1是说明性无引线心脏起搏器(LCP)的示意性框图。
图2是另一个说明性医疗设备的示意性框图。
图3是包括多个LCP和/或彼此通信的其他设备的示例性医疗系统的示意图；
图4是根据本公开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描绘了用于提供来自LCP的起搏刺激脉冲的说明性方法的示意流程图；
图6描绘了用于利用LCP识别捕获阈值的说明性方法的示意流程图；
图7描绘了说明性强度-持续时间(strength-duration)曲线的曲线图；
图8描绘了多个说明性强度-持续时间曲线的曲线图；
图9描绘了与LCP结合使用的远程设备的说明性用户界面的示意图；
图10描绘了用于设定由LCP提供的起搏刺激脉冲的参数的说明性方法的示意流程图；
图11描绘了用于设定由LCP提供的起搏刺激脉冲的参数的另一个说明性方法的示意流程图；和
图12描绘了用于随时间调节由LCP提供的起搏刺激脉冲的参数的说明性方法的示意流程图。
虽然本公开可修改为各种修改和替换形式，但是其细节已经通过附图中的实施例示出并且将被详细描述。然而，应该理解，本发明不是意图将本公开的各方面限制于所描述的特定说明性实施例。相反，本发明是意图覆盖落入本公开的精神和范围内的所有修改、等同物和替代物。
具体实施方式
应参考附图阅读以下描述，其中不同附图中的类似元件编号相同。描述和不一定按比例绘制的附图描绘了说明性实施例，并且不旨在限制本公开的范围。
本公开总体上涉及心脏起搏设备，并且更具体地涉及用于为这种心脏起搏设备设定起搏脉冲参数的系统、设备和方法。在说明性实施例中，心脏起搏设备可以包括无引线心脏起搏器(LCP)。无引线心脏起搏器可以被配置为植入在患者的心脏中或患者的心脏上，并且可以将起搏脉冲递送到患者的心脏。虽然无引线心脏起搏器在本公开中用作示例，但是预期的是本文所公开的概念可以应用于被配置为将心脏起搏脉冲递送到患者的心脏的任何合适的心脏起搏设备。
图1是说明性无引线心脏起搏器(LCP)的示意性框图。说明性LCP可以植入在心脏上或心脏腔室内的并且可以工作以感测生理信号和参数并且将一种或多种类型的电刺激治疗递送到患者的心脏的。示例电刺激治疗可包括心动过缓起搏、速率响应起搏治疗、心脏再同步治疗(CRT)、和/或抗心动过速起搏(ATP)治疗等。所公开的概念可以在其他IMD和/或其他设备中实现，包括但不限于具有引线的起搏器、除颤器和/或其他可植入或不可植入设备。
从图1中可以看出，LCP 100可以是紧凑型设备，其所有组件都容纳在LCP100内或直接在壳体120上。在一些情况下，LCP 100可包括通信模块102、脉冲发生器模块104、电感测模块106(例如，包括一个或多个电传感器)、机械感测模块108(例如，包括一个或多个机械传感器)、处理模块110(例如，包括存储器和一个或多个处理器的控制器)、能量存储模块112和电极114、114'。经由电路，电极114、114'可以是通信模块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和/或能量存储模块112的一部分和/或可以与其通信(例如，可操作地耦合到其)。
如图1所示，LCP 100可包括电极114，其可以相对于壳体120固定并且电暴露于LCP100周围的组织和/或血液。电极114通常可向LCP 100和周围组织和/或血液传导电信号，和/或从LCP 100和周围组织和/或血液传导电信号。这样的电信号可包括通信信号、电刺激脉冲和内在心电信号等。内在心电信号可包括由心脏产生的电信号，并且可以由心电图(ECG)表示。电极可以被认为是能够感测多个心跳中的每个心跳的传感器。
电极114可包括一种或多种生物相容的导电材料，诸如已知可安全植入人体内的各种金属或合金。在一些情况下，电极114通常可布置在LCP 100的任一端上，并且可与模块102、104、106、108和110中的一个或多个电通信。在电极114(例如，两个或更多个电极114)直接固定到壳体120的实施例中，绝缘材料可将电极114与相邻电极、壳体120和/或LCP 100的其他部分电隔离。在一些情况下，电极114中的一些或全部可与壳体120间隔开，并且通过连接线连接到壳体120和/或LCP 100的其他部件。在这种情况下，电极114可以放置在远离壳体120延伸出的尾部(未示出)上。
如图1所示，在一些实施例中，LCP 100可包括电极114'。电极114'可以是电极114的补充，或者可以代替电极114中的一个或多个。电极114'可类似于电极114，除了电极114'布置在LCP 100的侧面上。在一些情况下，电极114'可增加LCP 100可以经由其递送通信信号和/或电刺激脉冲的电极的数量，和/或可以感测内在的心电信号、通信信号和/或电刺激脉冲。
电极114和/或114'可采用各种尺寸和/或形状中的任何一种，并且可以以各种间距中的任何一种间隔开。例如，电极114可以具有2至20毫米(mm)的外径。在其他实施例中，电极114和/或114'可具有两、三、五、七毫米(mm)的直径，或任何其他合适的直径、尺寸和/或形状。电极114和/或114'的示例长度可包括例如一、三、五、十毫米(mm)或任何其他合适的长度。如本文所用，长度是远离壳体120的外表面延伸的电极114和/或114'的尺寸。在一些情况下，电极114和/或114'中的至少一些可彼此间隔开二十、三十、四十、五十毫米(mm)的距离或任何其他合适的间距。单个设备的电极114和/或114'可以相对于彼此具有不同的尺寸，并且设备上的电极的间距和/或长度可以是或可以不是均匀的。
在所示的实施例中，通信模块102可以电耦合到电极114和/或114'，并且可以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、其他医疗设备等进行通信。本文使用的通信信号可以是任何调制信号，其通过自身或结合一个或多个其他调制信号而将信息传送到另一个设备。在一些实施例中，通信信号可以限于亚阈值信号，其不会导致心脏的捕获但仍传送信息。通信信号可以被递送到位于患者身体外部或内部的另一个设备。在一些情况下，通信可以采取由不同时间量分开的不同通信脉冲的形式。在这些情况的一些中，连续脉冲之间的定时可以传送信息。通信模块102可以另外被配置为感测由可以位于患者身体的外部或内部的其他设备递送的通信信号。
通信模块102可以通信以帮助完成一个或多个期望的功能。一些示例功能包括递送感测数据，使用所通信的数据来确定诸如心律失常的事件的发生，协调电刺激治疗的递送和/或其他功能。在一些情况下，LCP 100可以使用通信信号来通信原始信息、处理的信息、消息和/或命令、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)、和从耦合的传感器收集的信号等的信息。在一些实施例中，处理的信息可包括已使用一种或多种信号处理技术进行滤波的信号。处理的信息还可以包括由LCP 100和/或另一个设备确定的参数和/或事件，诸如确定出的心率、确定出的心跳的定时、其他确定出的事件的定时、阈值交叉的确定、监视的时间段的到期、加速度计信号、活动水平参数、血氧参数、血压参数、心音参数等。消息和/或命令可包括指示另一个设备采取动作的指令等、发送设备的即将发生的动作的通知、从接收设备读取的请求、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)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递送通信脉冲到哪个电极114和/或114'。预期的是通信模块102可以经由传导的信号、射频(RF)信号、光学信号、声学信号、电感耦合和/或任何其他合适的通信方法与其他设备通信。
在通信模块102产生电通信信号的情况下，通信模块102可包括一个或多个电容器元件和/或其他电荷存储设备，以帮助产生和递送通信信号。在所示实施例中，通信模块102可使用存储在能量存储模块112中的能量来产生通信信号。在至少一些示例中，通信模块102可包括连接到能量存储模块112的切换电路，并且利用切换电路，可将能量存储模块112连接到电极114/114'中的一个或多个以产生通信信号。
如图1所示，脉冲发生器模块104可以电连接到电极114和/或114'中的一个或多个。脉冲发生器模块104可以被配置为产生电刺激脉冲并经由电极114和/或114'中的一个或多个将电刺激脉冲递送到患者的组织，以便实现一种或多种电刺激治疗。每个电刺激脉冲可以具有脉冲幅度和脉冲宽度。
本文使用的电刺激脉冲意在包括可递送到患者组织以用于治疗任何类型疾病或异常目的的任何电信号。例如，当用于治疗心脏病时，脉冲发生器模块104可以产生电刺激起搏脉冲以捕获患者的心脏，即响应于所递送的电刺激脉冲使心脏收缩。在这些情况的一些情况中，LCP 100可以改变脉冲发生器模块104例如以速率自适应起搏产生电刺激脉冲的速率。在其他实施例中，电刺激脉冲可包括除颤/心脏复律脉冲，用于使心脏从纤维性颤动震动出或者进入正常心律。在又其他实施例中，电刺激脉冲可包括抗心动过速起搏(ATP)脉冲。应该理解，这些只是一些示例。当用于治疗其他疾病时，脉冲发生器模块104可以产生适合于神经刺激治疗等的电刺激脉冲。
脉冲发生器模块104可包括一个或多个电容器元件和/或其他电荷存储设备，以帮助产生和递送适当的电刺激脉冲。在至少一些实施例中，脉冲发生器模块104可使用存储在能量存储模块112中的能量来产生电刺激脉冲。在一些特定实施例中，脉冲发生器模块104可包括切换电路，该切换电路连接到能量存储模块112并且可将能量存储模块112连接到电极114/114'中的一个或多个以产生电刺激脉冲。
LCP 100可以包括电感测模块106。电感测模块106可被配置为感测从电极114和/或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114'并且电感测模块106可以被配置为经由传感放大器(sensoramplifier)等接收通过电极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LCP 100被植入在的腔室的局部信息。例如，如果LCP 100被植入在心脏的心室内，则由LCP 100通过电极114和/或114'感测的心电信号可以表示心室心电信号。在一些情况下，电感测模块106可以被配置为将多个心跳中的每个心跳识别为内在发起的心跳或起搏发起的心跳。
此外，LCP 100可以包括机械感测模块108。机械感测模块108可包括或电连接到各种传感器，诸如加速度计，包括多轴加速度计诸如两轴或三轴加速度计；陀螺仪，包括多轴陀螺仪诸如如两轴或三轴陀螺仪；血压传感器；心音传感器；压电传感器；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。当存在时，机械感测模块108可以从指示各种生理参数的传感器收集信号。
电感测模块106和机械感测模块108都可连接到处理模块110，并且可以将表示感测到的心电信号和/或生理信号的信号提供给处理模块110。尽管参照图1描述为单独的感测模块，但是在一些实施例中，电感测模块106和机械感测模块108可组合成单个模块。在至少一些示例中，LCP 100可仅包括电感测模块106和机械感测模块108中的一个。在一些情况下，处理模块110、电感测模块106、机械感测模块108、通信模块102、脉冲发生器模块104和/或能量存储模块的任何组合可被认为是LCP 100的控制器。
处理模块110(例如，控制器)可被配置为指引LCP 100的工作，并且在一些实施例中，可以称为控制器。例如，处理模块110可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可以例如基于患者的活动水平(例如速率自适应起搏)调节起搏频率。当如此提供时，处理模块110可监视患者的一个或多个生理参数，其可以指示对增加的心率的需要(例如，由于增加的代谢需求)并且增加脉冲发生器模块104产生电刺激脉冲的速率。使用LCP 100的机械感测模块108的运动传感器(例如，加速度计)确定患者的活动水平可以是具有挑战性的，这是因为运动传感器检测到的运动不仅包括患者的活动水平而且还包括跳动的心脏的运动。图6-10描述了使用LCP中的运动传感器(例如加速度计)帮助速率响应起搏的说明性方法。
在一些情况下，处理模块110可确定心律失常的发生和类型以及诸如LCP100是否已经离开原位的其他确定。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可以另外使用这样的所接收的信息来确定心律失常的发生和类型和/或诸如LCP 100是否已经离开原位的其他确定。在另一些附加实施例中，LCP 100可以使用所接收的信息而不是从电感测模块106和/或机械感测模块108接收的信号——例如，如果所接收的信息被认为比从电感测模块106和/或机械感测模块108接收的信号更准确，或者如果已经从LCP 100禁用或省略了电感测模块106和/或机械感测模块108。
在确定心律失常的发生之后，处理模块110可控制脉冲发生器模块104以根据一种或多种电刺激治疗产生电刺激脉冲，以治疗所确定的心律失常。例如，处理模块110可控制脉冲发生器模块104产生具有变化的和/或固定的参数(例如脉冲宽度、脉冲幅度和/或其他参数中的一个或多个)和不同序列的起搏脉冲，以实现一种或多种电刺激治疗。作为一个示例，在控制脉冲发生器模块104递送心动过缓起搏治疗时，处理模块110可控制脉冲发生器模块104递送具有特定脉冲宽度和脉冲幅度的起搏脉冲，该特定脉冲宽度和脉冲幅度被设计用于以规则间隔捕获患者心脏，以助于防止患者的心脏的度量低于预定阈值。
对于ATP治疗，处理模块110可控制脉冲发生器模块104以比患者的内在心率更快的速率递送起搏脉冲，以试图响应于所递送的起搏脉冲而不是响应于内在心电信号来迫使心脏搏动。一旦心脏跟随起搏脉冲，处理模块110就可控制脉冲发生器模块104将递送的起搏脉冲的速率降低到更安全的水平。在心脏再同步治疗(CRT)中，处理模块110可控制脉冲发生器模块104与另一个设备协调地递送起搏脉冲，以使心脏更高效地收缩。在脉冲发生器模块104能够产生用于除颤/心脏复律治疗的除颤和/或心脏复律脉冲的情况下，处理模块110可控制脉冲发生器模块104以产生这种除颤和/或心脏复律脉冲。在一些情况下，处理模块110可控制脉冲发生器模块104以产生电刺激脉冲以提供与上述那些示例不同的电刺激治疗。
除了控制脉冲发生器模块104产生不同类型的并且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产生具有变化的脉冲参数的各种电刺激脉冲。例如，每个电刺激脉冲可具有脉冲宽度和脉冲幅度。处理模块110可控制脉冲发生器模块104产生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可使脉冲发生器模块104调节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帮助LCP 100提供更有效的电刺激治疗的递送。
在一些实施例中，处理模块110还可控制通信模块102向其他设备发送信息。例如，处理模块110可控制通信模块102产生一个或多个通信信号以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产生特定脉冲序列的通信信号，其中特定序列传送不同的信息。通信模块102还可通过处理模块110接收用于潜在动作的通信信号。
在进一步的实施例中，处理模块110可控制切换电路，通过该切换电路，通信模块102和脉冲发生器模块104将通信信号和/或电刺激脉冲递送给患者的组织。如上所述，通信模块102和脉冲发生器模块104都可包括用于将一个或多个电极114和/114'连接到通信模块102和/或脉冲发生器模块104的电路，使得那些模块可将通信信号和电刺激脉冲递送到患者的组织。通信模块102和/或脉冲发生器模块104通过其递送通信信号和电刺激脉冲的一个或多个电极的特定组合可以影响通信信号的接收和/或电刺激脉冲的有效性。尽管描述了通信模块102和脉冲发生器模块104中的每个可包括切换电路，但是在一些实施例中，LCP 100可具有连接到通信模块102、脉冲发生器模块104和电极114和/或114'的单个切换模块。在这样的实施例中，处理模块110可控制切换模块适当地连接模块102/104和电极114/114'。
在一些实施例中，处理模块110可包括预编程芯片，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，芯片可使用控制逻辑进行预编程，以便控制LCP 100的工作。通过使用预编程芯片，处理模块110可使用比其他可编程电路更少的功率，而同时能够维持基本功能，从而潜在地增加LCP 100的电池寿命。在其他情况下，处理模块110可包括可编程微处理器等。这种可编程微处理器可允许用户在制造之后调节LCP 100的控制逻辑，从而允许LCP 100比在当使用预编程芯片时具有更大的灵活性。在又其他实施例中，处理模块110可以不是单个组件。例如，处理模块110可包括位于LCP 100内的不同位置的多个组件，以便执行各种描述的功能。例如，某些功能可在处理模块110的一个组件中执行，而其他功能在处理模块110的单独组件中执行。
处理模块110可包括存储器电路，并且处理模块110可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可包括与处理模块110通信的单独的存储器电路(未示出)，使得处理模块110可向单独的存储器电路写入信息和从该单独的存储器电路读取信息。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分开，都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可以是电源并且向LCP 100提供电源(例如电源电压)以用于其工作。在一些实施例中，能量存储模块112可以是不可再充电的锂基电池。在其他实施例中，不可再充电电池可由其他合适的材料制成。在一些实施例中，能量存储模块112可包括可再充电电池。在又其他实施例中，能量存储模块112可以包括其他类型的能量存储设备，诸如电容器或超级电容器。
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。为了便于固定，LCP 100可包括一个或多个锚定件116。图1中示意性地示出了一个或多个锚定件116。一个或多个锚定件116可包括任何数量的固定或锚定机构。例如，一个或多个锚定件116可包括一个或多个销、钉、螺纹、螺钉、螺旋部、和/或齿等。在一些实施例中，尽管未示出，但是一个或多个锚定件116可在其外表面上包括螺纹，该螺纹可沿锚定构件的至少一部分长度延伸。螺纹可在心脏组织和锚定件之间提供摩擦力，以帮助将锚定构件固定在心脏组织内。在一些情况下，一个或多个锚定件116可包括：具有可以被旋拧入心脏组织的螺旋锥(cork-screw)形状的锚定构件。在其他实施例中，锚定件116可包括其他结构诸如倒钩或长钉等，以便于与周围心脏组织接合。
在一些示例中，LCP 100可被配置为植入在患者的心脏上或患者心脏的腔室内。例如，LCP 100可植入患者心脏的左心房、右心房、左心室或右心室中的任何一个内。通过植入在特定腔室内，LCP 100能够感测源自特定腔室或从特定腔室发出的其他设备可能无法以这种分辨率感测到的心电信号。在LCP 100被配置为植入在患者心脏上的情况下，LCP 100可被配置为植入在心脏的一个腔室上或邻近其植入，或者植入在内在产生的心电信号通常跟随沿着的路径上或邻近其植入。在这些示例中，LCP 100还可具有增强的能力来感测局部内在心电信号并递送局部电刺激治疗。在LCP 100包括加速度计的实施例中，LCP 100可以另外地能够感测LCP 100所附接到的心壁的运动。
图2描绘了另一设备、医疗设备(MD)200的实施例，其可工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。在所示实施例中，MD 200可包括通信模块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中的每个可以以一种或多种方式与LCP 100的模块102、104、106、108和110类似和/或不同。另外地，能量存储模块218可以以一种或多种方式与LCP 100的能量存储模块112类似和/或不同。然而，在一些实施例中，MD 200在壳体220内可具有比LCP 100的体积更大的体积。在这样的实施例中，MD 200可包括更大的能量存储模块218和/或能够处理比LCP 100的处理模块110更复杂工作的更大的处理模块210。
虽然MD 200可以是如图1所示的另一个无引线设备，但是在某些情况下，MD 200可包括引线诸如引线212。引线212可包括在电极214和位于壳体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可连接到MD200的壳体220并且远离MD 200的壳体220延伸。在一些实施例中，引线212可以植入在患者的心脏上、患者的心脏内或邻近患者的心脏。引线212可包含位于引线212上的各个位置以及距壳体220的各种距离处的一个或多个电极214。一些引线212可仅包括单个电极214，而其他引线212可包括多个电极214。通常，电极214可位于引线212上，使得当引线212植入患者体内时，定位一个或多个电极214以执行所需的功能。在一些情况下，一个或多个电极214可与患者的心脏组织接触。在其他情况下，一个或多个电极214可皮下定位但邻近患者的心脏。
MD 200还可包括未布置在引线212上的一个或多个电极214。例如，一个或多个电极214可直接连接到壳体220。
电极214可将内在产生的心电信号传导到引线212。引线212继而可将所接收的心电信号传导到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可产生电刺激信号(例如具有信号宽度和信号幅度，诸如脉冲宽度和脉冲幅度)，并且引线212可将所产生的电刺激信号传导到电极214。然后，电极214可将电刺激信号(直接或间接)传导到患者的心脏组织。
在一些实施例中，引线212可另外包含一个或多个传感器，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。在这样的实施例中，机械感测模块208可与引线212电通信并且可接收从这样的传感器产生的信号。
虽然不是必需的，但在一些实施例中，MD 200可以是可植入医疗设备。在这样的实施例中，MD 200的壳体220可植入例如患者的经胸区域中。壳体220通常可包括以下许多已知材料中的任何一种，这些材料对于植入人体是安全的，并且当植入时，可将MD200的各种部件与患者身体的流体和组织气密地密封。在这样的实施例中，引线212可植入在患者内的一个或多个不同位置处，诸如在患者的心脏内，邻近患者的心脏，邻近患者的脊柱，或任何其他期望的位置。
在一些实施例中，MD 200可以是可植入心脏起搏器(ICP)。在这些实施例中，MD200可具有被植入患者心脏上或患者心脏内的一个或多个引线例如引线212。一个或多个引线212可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可被配置为感测内在产生的心电信号，并且例如基于对所感测的信号的分析来确定一个或多个心律失常。MD 200可被配置为经由植入心脏内的引线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可以另外被配置为提供除颤/心脏复律治疗。
在一些情况下，MD 200可以是可植入心律转复除颤器(ICD)。在这样的实施例中，MD 200可包括植入在患者心脏内的一个或多个引线。MD 200还可被配置为感测心电信号，基于所感测的心电信号确定快速性心律失常的发生，并且(例如通过递送除颤和/或心脏复律脉冲到患者的心脏)响应于确定出快速性心律失常的发生而递送除颤和/或心脏复律治疗。在其他实施例中，MD 200可以是皮下可植入心律转复除颤器(SICD)。在MD 200是SICD的实施例中，引线212之一可以是皮下植入的引线。在MD 200是SICD的至少一些实施例中，MD200可仅包括皮下植入但在胸腔外部的单个引线，但是这不是必需的。
在一些实施例中，MD 200可以不是可植入医疗设备。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。在这样的实施例中，MD200可以能够感测表面电信号(例如，由心脏产生的心电信号或由植入患者体内的设备产生并通过身体传导到皮肤的电信号)。MD 200还可被配置为递送各种类型的电刺激治疗，包括例如经由皮肤电极214的除颤治疗。
图3示出了医疗设备系统和通信路径的实施例，医疗设备系统的多个医疗设备100a、100b、306和/或310可通过该通信路径进行通信。在所示实施例中，医疗设备系统300可包括第一LCP 100a和第二LCP 100b、外部医疗设备306和其他传感器/设备310。
外部设备306可以是布置在患者身体外部的设备，如先前关于MD 200所描述的。在至少一些示例中，外部设备306可表示外部支持设备诸如设备编程器，如将在以下更详细描述的。
其他传感器/设备310可以是先前关于MD 200描述的任何设备，诸如ICP、ICD和SICD。其他传感器/设备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/设备310可包括可用于对系统300的一个或多个设备进行编程的外部编程器设备。
系统300的各种设备可经由通信路径308进行通信。例如，LCP 100a和/或100b可感测内在心电信号并且可以经由通信路径308将这种信号传送到系统300的一个或多个其他设备100a/100b、306和310。在一个实施例中，设备100a/100b中的一个或多个可接收这样的信号，并且基于所接收的信号，确定心律失常的发生。在一些情况下，一个或多个设备或设备100a/100b可将这样的确定传送到系统300的一个或多个其他设备306和310。在一些情况下，系统300的设备100a/100b、306和310中的一个或多个可基于所传送的心律失常的确定而采取行动(诸如通过向患者的心脏递送合适的电刺激)。系统300的设备100a/100b、306和310中的一个或多个可另外经由通信路径308传送命令或响应消息。命令消息可使接收设备采取特定动作，而响应消息可包括所请求的信息或者接收设备事实上确实接收到了传送的消息或数据的确认。
预期的是系统300的各种设备可使用RF信号、电感耦合、光学信号、声学信号或适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，系统300的各种设备可使用多种信号类型经由路径308进行通信。例如，其他传感器/设备310可使用第一信号类型(例如，RF通信)与外部设备306通信，但是使用第二信号类型(例如，传导的通信)与LCP 100a/100b通信。此外，在一些实施例中，可限制设备之间的通信。例如，如上所述，在一些实施例中，LCP 100a/100b可仅通过其他传感器/设备310与外部设备306通信，其中LCP100a/100b可向其他传感器/设备310发送信号，并且其他传感器/设备310将接收的信号中继到外部设备306。
在一些情况下，系统300的各种设备可使用传导的通信信号经由路径308进行通信。因此，系统300的设备可具有允许这种传导的通信的组件。例如，系统300的设备可被配置为经由发送设备的一个或多个电极将传导的通信信号(例如，用电流和/或电压脉冲截断(punctuate)的电压和/或电流波形，在此称为电通信脉冲)发送到患者体内，并且可经由接收设备的一个或多个电极接收传导的通信信号。患者的身体可将传导的通信信号从系统300中的发送设备的一个或多个电极“传导”到接收设备的电极。在这样的实施例中，所递送的传导的通信信号可不同于起搏脉冲、除颤和/或心脏复律脉冲，或其他电刺激治疗信号。例如，系统300的设备可以以作为亚阈值的幅度/脉冲宽度递送电通信脉冲。也就是说，通信脉冲具有被设计成不捕获心脏的幅度/脉冲宽度。在一些情况下，所递送的电通信脉冲的幅度/脉冲宽度可高于心脏的捕获阈值，但是可在心脏的不应期期间递送和/或可并入起搏脉冲或调制到起搏脉冲上(如果需要的话)。
另外，与正常电刺激治疗脉冲不同，电通信脉冲可以以将信息传送给接收设备的特定序列递送。例如，可以任何合适方式调制所递送的电通信脉冲以编码通信的信息。在一些情况下，通信脉冲可以是脉冲宽度被调制的和/或幅度被调制的。可替代地或另外地，可以调制脉冲之间的时间以编码期望的信息。在一些情况下，预定义的通信脉冲序列可表示相应的符号(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，传导的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描绘了说明性医疗设备系统400。例如，系统400可包括多个设备，其植入患者内，并且被配置为感测生理信号，确定心律失常的发生，并且递送电刺激以治疗所检测的心律失常。在一些实施例中，系统400的设备可被配置为确定系统400的一个或多个设备的移位(dislodgment)的发生。在图4中，示出了LCP 100固定到心脏410的右心室的内部，并且示出了脉冲发生器406耦合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可以是皮下可植入心律转复除颤器(SICD)的一部分，并且一个或多个电极408a-408c可邻近心脏而皮下定位。LCP 100可诸如经由通信路径308与SICD通信。图4中描绘的LCP 100、脉冲发生器406、引线412和电极408a-c的位置仅是示例性的。在系统400的其他实施例中，根据需要，LCP 100可定位在心脏的左心室、右心房或左心房中。在又其他实施例中，LCP 100可邻近心脏410外部植入或甚至远离心脏410植入。
医疗设备系统400还可包括外部支持设备420。外部支持设备420可以用于执行诸如设备识别、设备编程和/或使用这里描述的一个或多个通信技术的设备之间的实时和/或所存储数据的传输的功能，或涉及与系统400的一个或多个设备通信的其他功能。作为一个示例，外部支持设备420和脉冲发生器406之间的通信可以经由无线模式执行，并且脉冲发生器406和LCP 100之间的通信可以经由传导的通信模式执行。在一些实施例中，LCP 100和外部支持设备420之间的通信是通过脉冲发生器406发送通信信息来完成的。然而，在其他实施例中，LCP 100和外部支持设备420之间的通信可以经由通信模块进行。
图4仅示出了医疗设备系统的一个示例实施例，该医疗设备系统可被配置为根据本文公开的技术进行工作。其他示例性医疗设备系统可包括另外的或不同的医疗设备和/或配置。例如，适合于根据本文公开的技术工作的其他医疗设备系统可包括植入心脏内的另外的LCP。另一个示例性医疗设备系统可包括具有或不具有诸如脉冲发生器406的其他设备的多个LCP，其中至少一个LCP能够递送除颤治疗。又另一个示例可包括一个或多个LCP，其与经静脉起搏器一起植入并且具有或不具有植入的SICD。在又其他实施例中，医疗设备、引线和/或电极的配置或放置可以与图4中描绘的那些不同。因此，应该认识到，不同于图4中描绘的系统400的许多其他医疗设备系统可根据本文公开的技术工作。因此，图4中所示的实施例不应被视为以任何方式的限制。
可植入医疗设备，诸如LCP 100，通常具有能量存储模块112，其具有有限的功率容量。能量存储模块112的功率容量通常指定了可植入医疗设备的有用寿命预期。在许多情况下，由可植入医疗设备递送的起搏刺激脉冲支配来自能量存储模块112的能量消耗。因而，增加起搏刺激脉冲的能量效率可以增加能量存储模块112的寿命并因此增加可植入医疗设备的寿命，和/或可以减小能量存储模块112的尺寸(例如，物理尺寸和/或存储尺寸)，并从而减小可植入医疗设备的尺寸。
在一些情况下，可植入医疗装置可以包括线性功率调节器，以将由能量存储模块112产生的电池电压(例如，电池电压)转换为可植入医疗设备使用的另一电压。例如，在一些情况下，可植入医疗设备可以具有5伏的电池电压，但可以以2.5伏的起搏幅度递送起搏脉冲。线性功率调节器可以将5伏电池电压转换为用于产生起搏脉冲的2.5伏。对于线性功率调节器，该转换的最大效率可以是输出电压(2.5V)与输入电压(5V)的比率，或者在这种情况下为50％。用于将电池电压转换为另一电压的其他电路的转换效率也低于意图。为了克服这种低效率，预期的是起搏脉冲幅度可以设定在电池电压处或其附近，并且可以调节脉冲宽度直到产生可靠地捕获心脏的起搏脉冲为止。
图5描绘了用LCP(诸如图1的LCP 100)起搏心脏的说明性方法150的示意流程图。说明性方法150包括诸如通过LCP 100的电极114和/或114'中的两个或更多个来识别152用于递送到患者心脏的起搏刺激脉冲的捕获阈值。该“捕获阈值(capture threshold)”可以通过改变脉冲幅度和/或脉冲宽度直到发现正好捕获心脏的刺激脉冲为止来识别。
方法150还可以包括递送154以下起搏刺激脉冲，其具有用于第一起搏脉冲参数(例如，脉冲幅度、脉冲宽度和/或其他参数)的值和用于第二起搏脉冲参数(例如，脉冲幅度、脉冲宽度和/或其他参数)的值，所述值至少部分地基于所识别的捕获阈值。在一个示例中，所递送的起搏刺激脉冲可以具有对应于捕获阈值的第一起搏脉冲参数(脉冲幅度)和第二起搏脉冲参数(脉冲宽度)。在另一个示例中，所递送的起搏刺激脉冲可具有第一起搏脉冲参数(脉冲幅度)和/或第二起搏脉冲参数(脉冲宽度)，其是对应于捕获阈值的参数的倍数，从而提供超出所识别的捕获阈值的捕获裕度。在另一个示例中，所递送的起搏刺激脉冲可以具有第一起搏脉冲参数(脉冲幅度)和第二起搏脉冲参数(脉冲宽度)，其从提供了超出所识别的捕获阈值的捕获裕度的强度-持续时间曲线导出。这些只是示例。在一些情况下，响应于处理模块110确定出需要起搏刺激脉冲或将要发起起搏刺激脉冲，起搏刺激脉冲可以通过电极114和/或144'从LCP 100递送到患者的心脏。
图6描绘了用于识别捕获阈值的说明性方法160的示意流程图。说明性方法160包括将第一起搏脉冲参数设定162为固定值(例如，第一固定值)。在一个示例中，第一起搏脉冲参数可以是起搏刺激脉冲的脉冲幅度，并且在一些情况下，该固定值可以设定在LCP 100的能量存储模块112的电池电压处。在一些情况下，该第一固定值可以被认为“固定”了至少一段时间。
一旦第一起搏脉冲参数被设定为固定值，说明性方法160就将一个或多个起搏刺激脉冲递送164到患者的心脏。在一个示例中，起搏刺激脉冲可以由LCP100的处理模块110发起、由脉冲发生器模块104生成、并且通过电极114和/或114'中的一个或多个递送。然而，可以使用其他起搏刺激脉冲递送技术。在将第一起搏脉冲参数保持在固定值的同时，说明性方法160可以改变166第二起搏脉冲参数(例如脉冲宽度)的值。在一些情况下，第二起搏脉冲参数的值可以在捕获阈值测试期间在不同的起搏脉冲上变化，直到捕获到患者的心脏(例如，如由电感测模块106和/或处理模块110识别出)为止。第二起搏脉冲参数的值可以以任何方式变化，包括但不限于，在一组起搏刺激脉冲的顺序起搏刺激脉冲上改变第二起搏脉冲参数的值；向第一组起搏刺激脉冲提供第二起搏脉冲参数的第一值并然后向下一组(例如，第二组或又一组)起搏刺激脉冲提供第二起搏脉冲参数的第二值；和/或以任何其他合适的方式。可替换地，第一起搏脉冲参数可以是起搏刺激脉冲的脉冲宽度，并且脉冲幅度可以针对两个或更多个起搏刺激脉冲而变化。
一旦从递送起搏刺激脉冲识别出捕获阈值，说明性方法160就可以包括识别168用于第二起搏脉冲参数的捕获值。捕获值可以对应于当识别出捕获阈值时所使用的第二起搏脉冲参数的值。在一个示例中，在第二起搏脉冲参数是脉冲宽度的情况下，可以在递送一个或多个起搏刺激脉冲期间改变脉冲宽度的值(例如，时间长度)以识别捕获脉冲宽度，其对应于用于第一起搏脉冲参数(例如，设定脉冲幅度)的设定固定值的捕获阈值。在识别出捕获阈值(例如，捕获脉冲宽度和设定脉冲幅度，或第一起搏脉冲参数和第二起搏脉冲参数的其他值)之后，LCP 100可以经由电极114和/或114'递送一个或多个起搏脉冲，其具有用于第一起搏脉冲参数和第二起搏脉冲参数的值，该值等于或大于第一起搏脉冲参数的固定值并且/或者等于或大于第二起搏脉冲参数的捕获值(例如，参见图5中方法150的递送步骤154)。
在一些情况下，LCP 100的处理模块110可以发起识别和/或可以识别用于起搏脉冲刺激的捕获阈值。在一些情况下，处理模块110可以在所识别的事件之后、在患者改变位置或姿势之后、在患者改变活动水平之后、和/或在一个或多个其他时间处，以预定时间间隔发起识别和/或可以识别捕获阈值。
图7描绘了具有沿X轴的脉冲持续时间(例如，毫秒(ms))和沿Y轴的脉冲幅度的说明性强度-持续时间曲线170。对于落在特定强度-持续时间曲线上的起搏刺激脉冲的X值(例如，脉冲持续时间)和Y值(例如，脉冲幅度)的所有组合，相同或基本相同的刺激效果由所述起搏刺激脉冲被提供给患者的心脏。如图7的示例所示，强度-持续时间曲线170上的点A处的起搏刺激脉冲相对于用于点B处的起搏刺激脉冲的第一起搏脉冲参数的值和第二起搏脉冲参数的值而言，具有用于第一起搏脉冲参数(例如，起搏幅度)的更高值和用于第二起搏脉冲参数(例如，脉冲宽度)的更低值。然而，在点A和点B处的每个起搏脉冲参数集可以提供对患者心脏的相同或基本相同的刺激效果(例如，两者都会类似地捕获心脏)。
在一些情况下，一个或多个强度持续时间曲线可以被保存在LCP 100的存储器(例如，处理模块110的存储器和/或其他存储器)中和/或LCP 100可以与之通信的存储器中。在一些情况下，可以存储强度-持续时间曲线族。强度-持续时间曲线族可以基于手边的特定患者或患者群体。图8中示出了说明性强度-持续时间曲线族。LCP 100可以使用针对特定患者的所识别的捕获阈值(如通过由植入的LCP 100执行的捕获阈值测试所确定的那样)，以识别对应于针对特定患者的捕获阈值的强度-持续时间曲线族中的特定一个强度-持续时间曲线。一旦被识别，LCP可以固定脉冲幅度(例如，在电池电压下)，并然后向右挑选“第n”强度-持续时间曲线，以识别提供了适当捕获裕度的脉冲宽度。然后，LCP可以使用具有固定脉冲幅度(例如电池电压)和提供了适当捕获裕度的脉冲宽度的起搏脉冲来起搏患者的心脏。
在一些情况下，LCP 100可以使用一个或多个强度持续时间曲线来调节第一起搏脉冲参数的值和/或第二起搏脉冲参数的值，而同时保持起搏脉冲的刺激效果。在图7的示例中，点A可以表示识别出捕获所处的起搏刺激脉冲，并因此点A处以及沿着强度-持续时间曲线170的刺激效果可以被认为是捕获阈值。在一些情况下，处理模块110可以确定出，更加功率高效的是：在第一起搏脉冲参数的较低值处工作、并且将第二起搏脉冲参数的值调节为沿着强度-持续时间曲线170与第一起搏脉冲参数的较低值相关联的值(例如，在强度-持续时间曲线170上的点B处)。这可以导致更高效地提供起搏刺激脉冲，而同时保持由所述起搏刺激脉冲施加到患者心脏的刺激效果。在一些情况下，根据需要，可以将捕获裕度应用于第一起搏脉冲参数和/或第二起搏脉冲参数。
在一个示例中，处理模块110可以将第一起搏脉冲参数的值设定(例如，固定)为等于由能量存储模块112提供的电源电压，并且可以在捕获阈值处识别脉冲宽度，并且因此识别与捕获阈值相关联的强度-持续时间曲线170(例如，其中强度-持续时间曲线可以存储在与LCP 100相关联的存储器中)。当能量存储模块112是电池并且电源电压是电池的电压时，电池的电压可能随时间衰减。结果，第一起搏脉冲参数的值也可能随时间与电池电压衰减成比例地衰减。为了考虑第一起搏脉冲参数的值的潜在衰减，处理模块110可以跟踪电池电压，当电池电压随时间变化时调节第一起搏脉冲参数的值，并将沿着所识别的强度-持续时间曲线170的第二起搏脉冲参数(例如，起搏脉冲宽度)的值调节为对应于第一起搏脉冲参数的调节值的点，以提供提供了相同或相似刺激效果的起搏刺激脉冲。在一些情况下，捕获裕度应用于第二起搏脉冲参数，以帮助确保对心脏的可靠捕获前行。
图8描绘了多个强度-持续时间曲线。如上所述，强度-持续时间曲线族(例如，图8中描绘的五个强度-持续时间曲线170,172,174,176,178)可以保存在LCP 100的存储器中(例如，处理模块110的存储器和/或其他存储器)和/或LCP 100可以与之通信的存储器。在一些情况下，存储了强度-持续时间曲线族的LCP 100可以促进LCP 100(例如，处理模块110)根据所接收或所识别的捕获裕度来提供起搏刺激脉冲。例如，捕获裕度可以对应于捕获阈值的百分比偏移。当如此提供时，当捕获阈值更高时捕获裕度可以更高。在另一个示例中，捕获裕度可以对应于与捕获阈值的固定偏移。在又另一个示例中，在图8中可以通过将“n”个强度-持续时间曲线向右移动来选择捕获裕度，并然后使用由该强度-持续时间曲线指示的脉冲幅度和/或脉冲宽度。这些只是一些示例。
在图8中，强度-持续时间曲线170可以被认为与患者的捕获阈值相关联。也就是说，经由捕获阈值测试而识别的捕获阈值落在沿着强度-持续时间曲线170，诸如在点A处。与强度-持续时间曲线170右侧的强度-持续时间曲线172,174,176和178中的每一个相关联的起搏刺激脉冲可以提供根据强度-持续时间曲线170所提供的起搏刺激脉冲之上的捕获裕度。在一个示例中，与每个连续强度持续时间曲线172,124,126和178相关联的起搏刺激脉冲可以提供比由与强度持续时间曲线170相关联的起搏刺激脉冲所提供的脉冲宽度大百分之一(1％)、百分之二(2％)、百分之三(3％)、百分之五(5％)、百分之十(10％)、百分之二十(20％)、或任何其他合适量的脉冲宽度。在另一个示例中，与每个连续强度持续时间曲线172,124,126和178相关联的起搏刺激脉冲可以提供比与强度持续时间曲线170相关联的起搏刺激脉冲所提供的脉冲幅度大百分之一(1％)、百分之二(2％)、百分之三(3％)、百分之五(5％)、百分之十(10％)、百分之二十(20％)、或任何其他合适量的脉冲幅度。在又另一示例中，与每个连续强度-持续时间曲线172,124,126和178相关联的起搏刺激脉冲可以从能量存储模块112消耗比与强度持续时间曲线170相关联的起搏刺激脉冲所汲取的功率量多百分之一(1％)、百分之二(2％)、百分之三(3％)、百分之五(5％)、百分之十(10％)、百分之二十(20％)、或任何其他合适量的功率。在另一个示例中，与每个连续强度持续时间曲线172,124,126和178相关联的起搏刺激脉冲可以提供比由与强度持续时间曲线170相关联的起搏刺激脉冲所提供的刺激量多百分之一(1％)、百分之二(2％)、百分之三(3％)、百分之五(5％)、百分之十(10％)、百分之二十(20％)、或任何其他合适量的刺激量。这些只是示例。此外，不是从一个强度-持续时间曲线172,124,126和178到下一个强度-持续时间曲线的线性进展，而是预期的是可以存在非线性进展，诸如步进式进展、指数进展、对数进展、和/或根据需要的任何其他合适的进展。
在一些情况下，LCP 100的处理模块110可以至少部分地基于所识别的捕获阈值和从医生接收到的预定捕获裕度和/或捕获裕度来选择所存储的强度-持续时间曲线。在一些情况下，由LCP 100执行的捕获阈值测试所确定的捕获阈值可以不直接与所存储的强度-持续时间曲线对齐。在这种情况下，处理模块110可以选择(例如，自动地或在医生选择和/或批准时)最接近捕获阈值的强度-持续时间曲线。一旦LCP的处理模块110选择了与捕获阈值相关联的强度-持续时间曲线170，处理模块110就可以识别与预定的或接收到的捕获裕度相关联的另一强度-持续时间曲线。例如，捕获裕度可以对应于最接近捕获阈值的强度-持续时间曲线右侧的“第n”强度-持续时间曲线。
在示例中，LCP 100可以固定脉冲幅度(例如，在电池电压下)，并然后通过改变脉冲幅度来执行捕获阈值测试。在图8中，这可以对应于沿着强度-持续时间曲线170的点A。然后，LCP 100可以向右挑选“第n”强度-持续时间曲线，以识别提供适当捕获裕度的脉冲宽度。例如，LCP 100可以向右挑选第一(例如n＝1)强度-持续时间曲线172，并且对于固定脉冲幅度，在工作点C处找到新的脉冲宽度。工作点C提供了期望的起搏裕度，以帮助确保可靠的起搏前行。
在另一个示例中，LCP 100可以固定脉冲幅度(例如，在电池电压下)，并然后通过改变脉冲幅度来执行捕获阈值测试。在图8中，这可以对应于沿着强度-持续时间曲线170的点B。然后，LCP 100可以向右挑选“第n”强度-持续时间曲线，以识别提供了适当捕获裕度的脉冲宽度。例如，LCP 100可以向右挑选第一(例如n＝1)强度-持续时间曲线172，并且对于固定脉冲幅度，在工作点D处找到新的脉冲宽度。工作点D提供了期望的起搏裕度，以帮助确保可靠的起搏前行。如图8所示，点A和C具有相同的脉冲幅度，但具有不同的脉冲宽度以提供期望的捕获裕度。同样，点B和D具有相同的脉冲幅度，但具有不同的脉冲宽度以提供期望的捕获裕度。
在一些情况下，并且一旦选择了强度-持续时间曲线以提供期望的捕获裕度，并且由于电池电压降低而引起起搏幅度随时间下降，处理模块110就可以根据所选择的强度-持续时间曲线而自动调节起搏刺激脉冲的起搏脉冲宽度。例如，假设已经选择了图8的强度-持续时间曲线172以提供期望的捕获裕度和对应于点C的初始起搏幅度。处理模块110可以将起搏脉冲宽度设定为对应于工作点C。当电池随时间耗尽时，起搏幅度可以下降到点D。处理模块110可以将起搏脉冲宽度沿着强度-持续时间曲线172随时间自动地下降到工作点D，一直提供期望的捕获裕度而可能无需更新捕获阈值。
在一些情况下，医生可以选择期望的捕获裕度来使用。在调节或选择针对LCP 100的捕获裕度时，医生可以考虑一个或多个因素。一些因素可以包括但不限于：绝对脉冲幅度裕度(例如2伏)、相对脉冲幅度裕度(+10％)、绝对脉冲宽度裕度(例如50ms)、相对脉冲宽度裕度(+10％)、起搏脉冲能量裕度(例如比捕获阈值的能量多10％的能量)、基于LCP 100的期望寿命的裕度、和/或任何其他合适的裕度。预期的是医生可以使用用户界面(诸如图9中所示的用户界面180)来选择捕获裕度。
在一个示例中，捕获裕度可以与LCP 100的估计寿命(例如，持续时间)相关。因而，医生可以有机会从诸如图9中所示的用户界面180中选择功率效率值。基于所选功率效率值，适当的捕获裕度可以被选择在所选功率效率值处以当提供起搏刺激脉冲时使用。在一些情况下，可以选择脉冲幅度/脉冲宽度组合以实现所选功率效率值。在一些情况下，可能不向医生报告特定的脉冲幅度和/或脉冲宽度。取而代之，可以优化脉冲幅度和/或脉冲宽度以降低LCP 100的总功耗。例如，为了使将电池电压转换为不同的起搏脉冲幅度所消耗的能量最小化，脉冲幅度可以被设定等于电池电压，并且可以调节脉冲宽度以实现期望的捕获裕度。捕获裕度可以取决于医生所选择的功率效率值。
用户界面180可以是可以通过网络(例如，通信路径308)与LCP 100通信的远程设备(例如，外部设备360、外部支持设备420和/或不同的远程设备)的一部分。可替代地或另外地，用户界面180可以位于个人计算机、膝上型计算机、平板电脑、移动电话、智能电话和/或其他计算设备中或其上，其中所选择的值可以被传送到LCP 100。
如可以看出的，用户界面180可以包括功率效率值选择器182。在所示的示例中，功率效率值选择器182可以是可以在最小(min)值和最大值(max)之间滑动的滑动条。另外地或可替代地，功率效率值选择器182可以允许用户选择值范围中的特定值，并且值可以用于通用范围(例如，0-10、0-100、14-29等)、可以与LCP 100的估计寿命(例如，以年计)相关联、可以与捕获阈值之上的捕获裕度百分比相关联、和/或可以与一个或多个其他值相关联。在一些情况下，用户界面180可以包括基于所选功率效率值(例如，随之改变)的LCP 100的估计寿命的指示符184(例如，动态指示符)。在一个示例中，随着经由功率效率值选择器182所选择的捕获裕度越高，LCP 100的剩余预期寿命的持续时间越短。
图10是为可以与所识别的捕获阈值相关的起搏刺激脉冲的参数设定值的说明性方法500的流程图。方法500可以包括LCP 100的将起搏幅度设定502为固定起搏幅度的处理模块110(注意，脉冲幅度和起搏幅度可以在本文中互换地使用)。在一个示例中，固定起搏幅度可以是能量存储模块112的电源电压(例如，电池电压)、电源电压的百分比和/或其他电压。然后，在经由电极114,114'向患者提供起搏刺激脉冲的同时，方法500可以包括调节504起搏刺激脉冲的脉冲宽度，直到已经识别出捕获阈值为止，并且然后选择506对应于捕获阈值的阈值强度持续时间曲线(例如，图7和8中的曲线170)。
作为如步骤502和504中的将起搏刺激脉冲的起搏幅度设定为固定起搏幅度并且调节起搏刺激脉冲的脉冲宽度以识别捕捉阈值的替代方案，处理模块110可以被配置为将起搏刺激脉冲的脉冲宽度设定为固定脉冲宽度并调节起搏刺激脉冲的起搏幅度以识别捕获阈值。
在步骤508处，处理模块110可以确定是否已经接收到捕获裕度，并且如果还没有接收到捕获裕度，则处理模块110可以至少部分地基于对应于捕获阈值的强度-持续时间曲线和默认捕获裕度(如果存在的话)来设定510电刺激脉冲设置。这可以包括：至少部分地基于默认捕获裕度和对应于所识别的捕获阈值的强度-持续时间曲线来自动选择捕获裕度强度持续时间曲线。然后，处理模块110可以至少部分地基于所选择的裕度强度-持续时间曲线来设定510电刺激脉冲设置。
在已经接收到诸如来自医生的捕获裕度的情况下，处理模块110可以至少部分地基于对应于捕获阈值的强度-持续时间曲线和所接收的捕获裕度来设定电刺激脉冲设置。这可以包括：至少部分地基于所接收的捕获裕度和对应于所识别的捕获阈值的强度-持续时间曲线来自动选择512捕获裕度强度持续时间曲线。然后，处理模块110可以至少部分地基于所选择的裕度强度-持续时间曲线来设定514电刺激脉冲设置。
图11是为可以与捕获阈值相关的起搏刺激脉冲的参数设定值的说明性方法600的流程图。在说明性方法600中，处理模块110可以识别602固定起搏幅度。在一个示例中，固定起搏幅度可以是能量存储模块112的电源电压(例如，电池电压)、电源电压的百分比和/或其他电压。处理模块110可以将起搏刺激脉冲的起搏幅度设定604为所识别的固定起搏的分数。在一个示例中，所设定的起搏幅度可以是能量存储模块112的电源电压的分数，并且可以基于期望的捕获裕度来设定。在一个示例中，如果捕获裕度是捕获阈值的2倍，则可以将分数设定为一半，并且所设定的起搏幅度将是所识别的固定起搏幅度的一半。一旦设定了起搏幅度并且在LCP 100可以将起搏刺激脉冲施加到患者的同时，处理模块110可以调节606起搏刺激脉冲的脉冲宽度，直到识别出捕获阈值为止。一旦识别出捕获阈值并且存储了起搏刺激脉冲的所设定的脉冲幅度处的相关联脉冲宽度，处理模块110就可以重新设定608起搏刺激脉冲以具有所识别的固定起搏幅度并且设定610起搏刺激脉冲以具有对应于在捕获阈值处识别出的脉冲宽度的脉冲宽度。得到的起搏刺激脉冲可以具有引起期望的捕获裕度(2X)的参数值。
在一些情况下，处理模块110可以识别与对应于捕获阈值的设定起搏脉冲参数值和期望的捕获裕度相关联的强度-持续时间曲线(例如，处理模块110可以选择可以是最接近设定起搏脉冲参数值的曲线的强度-持续时间曲线)并且当由于电源电压衰减等引起起搏幅度随时间变化时，随时间调节脉冲宽度。
图12是随时间调节起搏刺激脉冲的设定起搏幅度的说明性方法700的流程图。说明性方法700可以由LCP 100的处理模块110在以下时实现：植入之前和/或植入之后的设备的初始设置、植入设备的初始设置之后的预设间隔、植入设备的初始设置之后的连续地实时、和/或任何其他时间。说明性方法700可以包括处理模块110确定702用于设定起搏刺激脉冲的起搏幅度所处的固定起搏幅度，并确定704固定起搏幅度处的脉冲宽度。如本文所讨论的，在一个示例中，固定起搏幅度可以对应于能量存储模块112的电源电压(例如，电池电压)、电源电压的百分比和/或根据期望的其他电压。固定起搏幅度处的脉冲宽度可以通过以下确定：沿着强度-持续时间曲线(例如，图8中的强度-持续时间曲线170,172,174,176,178或其他强度-持续时间曲线)识别与固定起搏幅度相关联的脉冲宽度。一旦确定了702起搏刺激脉冲的固定起搏幅度并且确定了704起搏刺激脉冲的相关联脉冲宽度，处理模块110就可以将电刺激脉冲设置调节706为所确定的固定起搏幅度和所确定的脉冲宽度。
随着时间推移(例如，以预定的时间间隔或实时地)，处理模块110可以确定708用于确定固定起搏幅度的基础是否已经改变。在一个示例中，如果固定起搏幅度被设定为等于来自能量存储模块112的电源电压，则处理模块110可以确定来自能量存储模块112的电源电压是否已经改变了预定量(自先前确定了固定起搏幅度起)。该确定可以在预定时间和/或实时连续进行。如果处理模块110确定用于确定固定起搏幅度的基础还没有改变，则处理模块110可以维持710当前起搏刺激脉冲设置并且连续地确定708用于确定固定起搏幅度的基础是否已经改变。如果处理模块110确定用于确定固定起搏幅度的基础已经改变，则处理模块110可以返回到确定702固定起搏幅度(在其处要设定起搏刺激脉冲的起搏幅度)，并且可以重复方法700。
本领域技术人员将认识到，本公开可以以除了本文描述和考虑的具体实施方案之外的各种形式表现出来。例如，如本文所述，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，其他实施例可包括附加模块，其将所描述的功能分开到比本文描述的模块更多的模块上。另外，其他实施例可将所描述的功能合并为更少的模块。
尽管可能已经关于少于所有实施例描述了各种特征，但是本公开预期那些特征可包括在任何实施例中。此外，尽管本文描述的实施例可省略各种所描述的特征的一些组合，但是本公开预期包括每个所描述的特征的任何组合的实施例。因此，在不脱离如所附权利要求中描述的本公开的范围和精神的情况下，可在形式和细节上偏离。

Claims (15)

1.一种用于将起搏脉冲递送到患者的心脏的无引线心脏起搏器LCP，所述LCP包括：
电源，所述电源用于提供电源电压；
电极对，所述电极对用于将起搏脉冲递送到所述患者的心脏；
控制器，所述控制器可操作地连接到所述电极对和所述电源，所述控制器被配置为：
通过以下方式来识别捕获阈值：
将起搏幅度设定为所述电源电压；
经由所述电极对来递送以下多个起搏脉冲，其具有所述起搏幅度以及不同脉冲宽度，以识别对应于所述心脏的捕获阈值的捕获脉冲宽度；
经由所述电极对来递送以下多个起搏脉冲，其具有所述起搏幅度以及比所述捕获脉冲宽度大脉冲宽度裕度的起搏脉冲宽度；
其中，所述控制器存储了表示一个或多个强度-持续时间曲线的数据；并且
其中，当所述电源电压改变，并且因此所述起搏幅度改变时，所述控制器被配置为：至少部分地基于一个或多个强度-持续时间曲线来自动地调节所述起搏脉冲宽度，而不必经由所述电极对递送具有改变的起搏幅度和不同脉冲宽度的多个起搏脉冲来识别对应于所述心脏的捕获阈值的更新的捕获脉冲宽度。
2.根据权利要求1所述的LCP，其中，所述电源包括电池，并且所述电源电压包括由所述电池提供的电池电压。
3.根据权利要求2所述的LCP，其中，所述电池电压以及因此的所述起搏幅度随时间衰减。
4.根据权利要求2或3中任一项所述的LCP，其中，所述控制器被配置为不时地识别所述捕获阈值。
5.根据权利要求1所述的LCP，其中，所述控制器被配置为至少部分地基于所述起搏幅度和所述捕获脉冲宽度来识别捕获阈值强度-持续时间曲线，并且控制器还被配置为通过参考所述起搏幅度和强度-持续时间曲线中的不同一个来识别脉冲宽度裕度。
6.根据权利要求5所述的LCP，其中，所述控制器被配置为：至少部分地基于改变的起搏幅度和强度-持续时间曲线中的不同一个来自动地调节所述起搏脉冲宽度。
7.根据权利要求5或权利要求6中任一项所述的LCP，其中，所述控制器被配置为从远程设备接收表示所述一个或多个强度-持续时间曲线的数据。
8.根据权利要求1所述的LCP，其中，所述控制器还被配置为接收用户可选择功率效率值，并且其中，所述脉冲宽度裕度至少部分地基于所述用户可选择功率效率值。
9.根据权利要求8所述的LCP，其中，所述用户可选择功率效率值从远程设备被接收。
10.根据权利要求9所述的LCP，其中，所述远程设备包括用户界面，所述用户界面包括显示部，其中，用户能够使用所述用户界面来选择所述用户可选择功率效率值。
11.根据权利要求10所述的LCP，其中，所述用户界面显示滑块，所述滑块允许所述用户从可允许的用户可选择功率效率值的范围中选择所述用户可选择功率效率值。
12.根据权利要求10所述的LCP，其中，所述用户界面显示至少部分地基于所述用户可选择功率效率值的所述LCP的预期寿命的动态指示符。
13.一种用于将起搏脉冲递送到患者的心脏的无引线心脏起搏器LCP系统，所述LCP系统包括：
远程设备，所述远程设备具有用户界面，所述用户界面具有用于接收对用户可选择功率效率值的选择的显示部；
LCP，所述LCP远离所述远程设备并且与所述远程设备通信，LCP包括：
用于提供电源电压的电源；
用于将起搏脉冲递送到所述患者的心脏的电极对；
可操作地连接到所述电极对和所述电源的控制器，所述控制器被配置为：
从所述远程设备接收所述用户可选择功率效率值；
识别对应于捕获阈值的脉冲宽度和脉冲幅度组合；
将捕获裕度应用于所述脉冲宽度和脉冲幅度中的一个或多个，从而产生起搏脉冲宽度和起搏脉冲幅度，其中，所述捕获裕度至少部分地基于所述用户可选择功率效率值；
使用所述起搏脉冲宽度和所述起搏脉冲幅度来递送起搏脉冲；
其中，所述控制器存储了表示一个或多个强度-持续时间曲线的数据；并且
其中，当所述电源电压改变，并且因此起搏幅度改变时，所述控制器被配置为：至少部分地基于一个或多个强度-持续时间曲线来自动地调节所述起搏脉冲宽度。
14.根据权利要求13所述的LCP系统，其中，所述控制器被配置为通过将所述用户可选择功率效率值索引到表示一个或多个强度-持续时间曲线的所述数据中来识别所述捕获裕度。
15.根据权利要求13或权利要求14中任一项所述的LCP系统，其中，所述远程设备在显示部上显示了：
滑块，所述滑块允许所述用户从可允许的用户可选择功率效率值的范围中选择所述用户可选择功率效率值；和
至少部分地基于所述用户可选择功率效率值的LCP的预期寿命的动态指示符。
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