CN107530002B - 用于治疗心律失常的系统和方法 - Google Patents

用于治疗心律失常的系统和方法 Download PDF

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CN107530002B
CN107530002B CN201680025241.9A CN201680025241A CN107530002B CN 107530002 B CN107530002 B CN 107530002B CN 201680025241 A CN201680025241 A CN 201680025241A CN 107530002 B CN107530002 B CN 107530002B
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lcp100
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electrical stimulation
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艾伦·C·舒罗斯
罗德尼·W·萨洛
迈克尔·J·凯恩
唐纳德·L·霍珀
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Cardiac Pacemakers Inc
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
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    • A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
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Abstract

公开了用于速率适应性起搏的系统和方法。在一个说明性实施例中，一种用于向心脏递送电刺激的医疗装置可以包括被配置为在心脏上或心脏的腔室内植入的外壳、被连接至外壳的一个或多个电极以及设置于外壳内的控制器。控制器可以被配置为感测第一信号并至少部分地基于感测到的第一信号来确定呼吸速率。在至少一些实施例中，控制器可以被进一步配置为至少部分地基于所确定的呼吸速率来调整由医疗装置进行的电刺激递送的速率。

Description

用于治疗心律失常的系统和方法
相关申请的交叉引用
本申请要求于2015年3月4日提交的美国临时专利申请序列号62/128,340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系统、装置和方法，并且更具体地涉及用于实现速率适应性起搏的系统、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)已被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系统、装置和方法，并且更具体地涉及用于实现速率适应性起搏的系统、装置和方法。在一个说明性实施例中，一种用于向心脏递送电刺激的医疗装置可以包括被配置为在心脏上或心脏的腔室内植入的外壳、被连接至外壳的一个或多个电极以及设置于外壳内的控制器。控制器可以被配置为感测第一信号并至少部分地基于感测到的第一信号来确定呼吸速率。在至少一些实施例中，控制器可以被配置为至少部分地基于所确定的呼吸速率来调整由医疗装置进行的电刺激递送的速率。
在一些情况下，控制器可以包括一个或多个传感器，诸如一个或多个加速度计、阻抗传感器、压力传感器和/或压电传感器等。在一些情况下，控制器可以包括读出放大器等，其被连接至医疗装置的电极中的一个或多个以便经由医疗装置的一个或多个电极来直接地感测信号。
另外，或者可替代地，在上述说明性实施例中，控制器可以进一步被配置为至少部分地基于感测到的第一信号来确定相对潮气量参数，并且至少部分地基于所确定的呼吸速率和所确定的相对潮气量参数两者来调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是加速度计信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是温度信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是压力信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是应变信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是心电图(ECG)。
另外，或者可替代地，控制器被配置为如果所确定的呼吸速率上升至呼吸阈值以上则调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，控制器被配置为如果所确定的呼吸速率下降至等于呼吸阈值或在呼吸阈值以下则调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，控制器被进一步配置为感测第二信号，并且至少部分地基于所确定的呼吸速率和第二感测信号来调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，第二感测信号是心音信号。
另外，或者可替代地，控制器被配置为如果呼吸速率上升至呼吸阈值以上且第二感测信号上升至第二阈值以上则增加由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被配置为确定感测到的第一信号的绝对值。
另外，或者可替代地，在上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为确定感测到的第一信号的绝对值的积分。
另外，或者可替代地，在上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为用低通滤波器对积分信号进行滤波。
另外，或者可替代地，在上述说明性实施例中的任何一个中，低通滤波器具有在0.3Hz与0.7Hz之间的拐角频率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为确定低通滤波信号的一阶导数的过零点。
另外，或者可替代地，在上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为确定低通滤波信号的一阶导数的一对过零点之间的计时的差。
另外，或者可替代地，在上述说明性实施例中的任何一个中，控制器可以被进一步配置为在心脏的心动周期的固定点处对第一信号进行采样。
另外，或者可替代地，在上述说明性实施例中的任何一个中，控制器可以被进一步配置为在感测到的心电图(ECG)中的R波出现时对第一信号进行采样。
另外，或者可替代地，可以是上述说明性实施例中的任何一个中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器可以被进一步配置为用低通滤波器对第一感测信号进行滤波。
在另一说明性实施例中，一种向心脏递送电刺激的方法可以包括用被配置为在心脏上或在心脏的腔室内植入的无引线心脏起搏器(LCP)以第一递送速率向心脏递送电刺激。所述方法可以包括用LCP来感测第一信号，并且至少部分地基于第一感测信号来确定是否要改变电刺激递送的速率。在至少一些说明性实施例中，所述方法可以另外包括在确定要改变电刺激递送的速率之后用LCP以第二递送速率向心脏递送电刺激。
另外，或者可替代地，在上述说明性实施例中，所述方法还可以包括基于第一感测信号来确定呼吸速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，第一感测信号是加速度计信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，至少部分地基于增益因数来确定第二递送速率。
在另一说明性实施例中，一种用于向心脏递送电刺激的医疗装置可以包括被配置为在心脏上或心脏的腔室内植入的外壳、被连接至外壳的一个或多个电极以及设置于外壳内的控制器。在一些说明性实施例中，所述控制器可以被配置为感测第一信号并至少部分地基于感测到的第一信号来确定呼吸速率。在至少一些说明性实施例中，控制器可以被进一步配置为至少部分地基于所确定的呼吸速率来调整由医疗装置进行的电刺激递送的速率。
在一些情况下，控制器可以包括一个或多个传感器，诸如一个或多个加速度计、阻抗传感器、压力传感器和/或压电传感器等。在一些情况下，控制器可以包括读出放大器等，其被连接至医疗装置的电极中的一个或多个以便经由医疗装置的一个或多个电极来直接地感测信号。
另外，或者可替代地，在上述说明性实施例中，所述控制器可以被进一步配置为至少部分地基于感测到的第一信号来确定相对潮气量参数，并且至少部分地基于所确定的呼吸速率和所确定的相对潮气量参数来调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是加速度信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，感测到的第一信号是心电图(ECG)。
另外，或者可替代地，控制器被配置为如果所确定的呼吸速率上升至呼吸阈值以上则调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，控制器被配置为如果所确定的呼吸速率下降至等于呼吸阈值或在呼吸与之以下则调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，控制器被进一步配置为感测第二信号，并且至少部分地基于所确定的呼吸速率和第二感测信号来调整由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，第二感测信号是心音信号。
另外，或者可替代地，控制器被配置为如果呼吸速率上升至呼吸阈值以上且第二感测信号上升至第二阈值以上则增加由医疗装置进行的电刺激递送的速率。
另外，或者可替代地，在上述说明性实施例中的任何一个中，所述医疗装置是无引线心脏起搏器。
在另一说明性实施例中，一种向心脏递送电刺激的方法可以包括用被配置为在心脏上或在心脏的腔室内植入的无引线心脏起搏器(LCP)来感测第一信号并确定第一感测信号的绝对值。所述方法可以包括基于第一感测信号的绝对值来确定积分信号并至少部分地基于积分信号来确定呼吸速率。在至少一些说明性实施例中，所述方法还可以包括至少部分地基于呼吸速率的改变来改变电刺激的递送速率。
另外，或者可替代地，在上述说明性实施例中，基于积分信号来确定呼吸速率包括确定积分信号的一对峰值之间的计时的差。
另外，或者可替代地，在上述说明性实施例中的任何一个中，所述成对峰值中的每个峰值的值是局部最大值。
另外，或者可替代地，在上述说明性实施例中的任何一个中，基于积分信号来确定呼吸速率还包括对积分信号进行低通滤波，确定被低通滤波的信号的一阶导数的过零点，并且确定被低通滤波的信号的一阶导数的一对过零点之间的计时的差。
另外，或者可替代地，在上述说明性实施例中的任何一个中，第一感测信号是加速度计信号。
另外，或者可替代地，在上述说明性实施例中的任何一个中，第一感测信号是心电图(ECG)。
以上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。通过参考接合附图进行的以下描述和权利要求，本公开的优点和成就以及其更全面理解将变得显而易见并被认识到。
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，在所述附图中：
图1是根据本公开的一个说明性实施例的说明性无引线心脏起搏器(LCP)的示意性框图；
图2是在许多心动周期内描绘的说明性原始加速度计数据的图；
图3是图2的说明性原始加速度计数据的绝对值的图；
图4是基于图3的说明性原始加速度计数据的绝对值的积分信号的图；
图5是通过对图4的积分信号进行低通滤波生成的低通滤波信号的图；
图6是可以用医疗装置或医疗装置系统(诸如图1的说明性LCP)实现的说明性方法的流程图；并且
图7是可以用医疗装置或医疗装置系统(诸如图1的说明性LCP)实现的说明性方法的流程图。
虽然本公开可修改为多种改型和替代形式，但是已经在附图中以实施例的方式示出其特定细节，并将进行详细描述。然而，应理解的是并不意图使本公开的各方面局限于所描述的特定说明性实施例。相反地，意图涵盖落在本公开的精神和范围内的所有修改、等价物以及替换方案。
具体实施方式
应参考其中将不同图中的类似元件相同地编号的各图来阅读以下描述。本描述和不一定按比例的附图描绘说明性实施例，并且并不意图限制本公开的范围。
本公开描述了一种用于以速率适应性方式向心脏递送电刺激的系统、装置以及方法。健康人的身体一般地响应于较高或较低的新陈代谢需要而调整其心脏搏动的速率，例如在锻炼期间或者响应于各种外部刺激。然而，一些人逐渐产生影响其身体以有效方式促使其心脏收缩的能力的疾病或状况。因此，在此类人体内可以植入根据本公开的装置。在一些情况下，植入的装置可以以进行中为基础递送电刺激并根据指示出增加的新陈代谢需要的感测到的生理参数来调整所递送的生理参数的速率。
图1是示例性无引线心脏起搏器(LCP)的概念示意框图，其可以被植入心脏上或心脏的腔室内，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心脏。示例电刺激治疗可以包括心动过缓起搏，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。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。在一些情况下，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，并被电暴露于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信号、电刺激脉冲和固有心电信号，仅举几个例子。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可以包括一种或多种生物相容性导电材料，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LCP100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，绝缘材料可以将电极114与相邻电极、外壳120和/或LCP 100的其他部分电隔离。在一些情况下，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。在这样的情况下，电极114可以被放置在远离外壳120延伸出的尾部(未示出)上。如图1中示出的，在一些实施例中，LCP 100可包括电极114’。电极114’可以是除电极114之外的，或者可以替换电极114中的一个或多个。电极114’可以类似于电极114，除了电极114’被布置在LCP 100的侧面上。在一些情况下，电极114’可以增加LCP 100可以通过其递送通信信号和电刺激脉冲和/或可以感测固有心电信号、通信信号和/或电刺激脉冲的电极的数量。
电极114和/或114’可以采取各种尺寸和/或形状中的任何一种，并且可以以多种间距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)的外径。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/或形状。电极114和/或114’的示例长度可以包括例如一、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间距。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距和/或长度可能均匀或者可能不均匀。
在所示的实施例中，通信模块102可以被电耦接到电极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、编程器和/或其他医疗装置等的其他装置通信。如本文使用的，通信信号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，通信信号可以局限于不导致心脏捕捉的亚阈值信号仍传送信息。通信信号可以被递送至位于患者身体外部或内部的另一装置。在一些情况下，通信可以采取间隔开各种时间量的不同通信脉冲的形式。在这些情况中的一些中，连续脉冲之间的计时可以传送信息。通信模块102可以另外被配置为感测由位于患者身体的外部或内部的其他装置递送的通信信号。
通信模块102可以进行通信以帮助实现一个或多个期望功能。一些示例性功能包括可递送感测到的数据、将传送的数据用于确定诸如心律失常之类的事件的发生、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传送原始信息、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，已处理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。已处理信息还可以包括由LCP 100和/或另一装置确定出的参数和/或事件，诸如确定出的心率、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、活动水平参数、血氧参数、血压参数和心音参数等。消息和/或命令可以包括指导另一装置采取动作的指令等、发送装置即将发生的动作的通知、用于从接收装置读取的请求、向接收装置写入数据的请求、信息消息和/或其它消息命令。
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用来递送通信脉冲的哪个电极114和/或114’。可设想的是通信模块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/或任何其他适当通信方法与其他装置进行通信。在通信模块102生成电通信信号的情况下，通信模块102可以包括一个或多个电容器元件和/或其它电荷储存装置以帮助生成和递送通信信号。在所示的实施例中，通信模块102可以使用存储在能量存储模块112中的能量来生成通信信号。在至少一些示例中，通信模块102可以包括连接至能量存储模块112的开关电路，并且用开关电路，可以将能量存储模块112连接至电极114/114'中的一个或多个以生成通信信号。
如图1中所示，脉冲发生器模块104可以被电连接到电极114和/或114’中的一个或多个。脉冲发生器模块104可以被配置为生成电刺激脉冲并且经由电极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。例如，当被用于治疗心脏疾病时，脉冲发生器模块104可以生成电刺激起搏脉冲以便捕获患者的心脏，即促使心脏响应于递送的电刺激脉冲而收缩。在这些情况中的一些中，LCP 100可以改变脉冲发生器104生成电刺激脉冲的速率，例如在速率适应性起搏中。在另一实施例中，电刺激脉冲可以是用于将心脏从纤维性颤动震动出或使其震动进入正常心脏节律的除颤/心律转复脉冲。在另一实施例中，电刺激脉冲可以是抗心动过速起搏(ATP)脉冲。这些仅仅是一些示例。当被用来治疗其它疾病时，脉冲发生器模块104可以生成适于神经刺激治疗等的电刺激脉冲。脉冲发生器模块104可以包括一个或多个电容器元件和/或其它电荷储存装置以帮助生成和递送适当电刺激脉冲。在所示实施例中，脉冲发生器模块104可以使用存储在能量存储模块112中的能量来生成电刺激脉冲。在一些示例中，脉冲发生器模块104可以包括被连接至能量存储模块112的开关电路，并且可以将能量储存模块112连接至电极114/114'中的一个或多个以生成电刺激脉冲。
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和/或振幅来修改电刺激脉冲的能力。当对心脏进行起搏时，这可以帮助修整电刺激脉冲以捕捉特定患者的心脏，有时以减少的电池使用。对于神经刺激疗法而言，调整脉冲宽度和/或振幅可以帮助针对特定应用修整疗法和/或帮助使得疗法对于特定患者而言更有效。
虽然被描绘为单独模块，但在某些实施例中，LCP 550可以包括组合通信模块702/脉冲发生器模块704。例如，脉冲发生器模块704可以被配置为还生成电通信信号。在此类实施例中，脉冲发生器704可以被配置为生成并递送电通信信号和电刺激脉冲两者。
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可以被配置为经由传感器放大器等来接收通过电极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、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。机械感测模块108(当存在时)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。在至少一些示例中，LCP 100可以仅包括电感测106和机械感测模块108中的一个。在一些情况中，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以被视为LCP 100的控制器。
处理模块110可以被配置为指引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可以例如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，如果接收到的信息被认为比从电感测模块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。
在确定心律失常的发生之后，处理模块110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。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，以帮助防止患者的心脏降至预定阈值以下。在一些情况下，可以随着患者的活动水平增加而增加起搏速率(例如速率适应性起搏)。例如，处理模块110可以监视患者的一个或多个生理参数，其可以指示对增加心率的需要(例如由于增加的代谢需求)。处理模块110然后可以增加脉冲发生器104生成电刺激脉冲的速率。
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。一旦心脏遵循起搏脉冲，处理模块110就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更安全等级。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。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。在一些情况下，处理模块110可以控制脉冲发生器模块104生成电刺激脉冲，以提供不同于上文所述的那些示例的电刺激治疗。
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帮助LCP 100提供电刺激治疗的更有效递送。
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生成用于与装置系统的其他装置通信的一个或多个通信信号。例如，处理模块110可以控制通信模块102以特定脉冲序列生成通信信号，其中特定序列传送不同的信息。通信模块102还可以接收通信信号以用于由处理模块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信号和/或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/或脉冲发生器模块104的电路，所以这些模块可以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。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’的单个切换模块。在这种实施例中，处理模块110可以控制切换模块来适当地连接模块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，从而潜在地增加LCP 100的电池寿命。在其他情况中，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，LCP100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其他合适的材料制成。在一些实施例中，能量存储模块112可以包括可再充电电池。在其他实施例中，能量存储模块112可以包括其他类型的能量存储装置，诸如超级电容器。
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。为了促进固定，LCP 100可以包括一个或多个锚定件116。在图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可以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，但是一个或多个锚定件116可在其外表面上包括可沿着锚定构件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可以包括锚定构件，其具有可以拧入心脏组织中的螺旋拔塞器(cork-screw)形状。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。
在一些示例中，LCP 100可以被配置为植入于患者的心脏上或患者的心脏的腔室内。例如，可以将LCP 100植入于患者的心脏的左心房、右心房、左心室或右心室中的任何一个内。通过植入于特定腔室内，LCP 100可以能够感测源自于或发源于其他装置可能不能以此类分辨率感测的特定腔室的心电信号。在LCP 100被配置为植入于患者的心脏上的情况下，LCP 100可以被配置为植入于心脏的腔室中的一个或多个上或与其邻近或者固有生成的心电信号大体跟随的路径上或与其邻近。在这些示例中，CLP 100还可以具有感测局部化固有心电信号并递送局部化电刺激治疗的增强能力。
在一些情况下，LCP 100可以被配置为向患者的心脏递送速率适应性起搏治疗。例如，LCP 100可以被配置为以进行中为基础向患者的心脏递送电刺激脉冲以便以安全且有效的方式帮助确保患者的心脏收缩。LCP 100可以另外例如使用电感测模块106和/或机械感测模块108来感测一个或多个信号，并且基于感测到的一个或多个信号来确定是否要改变电刺激脉冲的递送速率。例如，基于感测到的一个或多个信号，LCP 100可以确定是否存在用于心脏输出的较少需要，并且可以减小电刺激脉冲的递送速率。在其他情况下，基于一个或多个感测到的信号，LCP 100可以确定用于增加的心脏输出的需要，并且可以增加电刺激脉冲的递送速率。基于感测到的一个或多个信号来调整电刺激脉冲的递送速率可以通过只有当感测到的一个或多个信号指示出存在用于增加的心脏输出的需要时才要求电刺激脉冲的较高递送速率来延长LCP 100的电池寿命。另外，调整电刺激脉冲的递送速率可以通过使电刺激脉冲的递送速率与患者的心脏输出需要更紧密地匹配来增加患者的舒适度水平。
在LCP 100基于感测到的一个或多个信号来调整电刺激脉冲的递送速率的情况下，LCP 100在一些情况下可以基于感测到的一个或多个信号来确定呼吸速率。呼吸速率可以指示出用于患者的相对心脏输出需要。例如，增加的呼吸速率可以指示出存在用于增加的心脏输出的需要，并且减小的呼吸速率可以指示出用于心脏输出的较少需要。因此，并且当这样提供时，LCP 100可以基于确定出的呼吸速率来调整电刺激脉冲的递送速率。
在至少一些示例中，LCP 100可以包括加速度计，并且可以基于感测到的加速度计信号来确定与呼吸速率有关的度量。在LCP 100被植入于患者的心脏上或心脏内的情况下，加速度计信号可以包括指示出与许多不同原因有关的移动的信号。例如，加速度计信号可以包括与患者的大体移动有关的移动，诸如行走、弯曲或其他大体身体移动。另外，加速度计信号可以包括与心脏的收缩有关的移动，特别是当LCP 100被植入于心脏上或其内部时。另外，加速度计信号可以包括与患者的吸气和呼气(即呼吸)有关的移动。例如，随着患者吸入和呼出，肺向心脏施加不同的压力，并且胸内压因此改变。胸内压的此改变可以引起心脏的各种腔室的形状和尺寸的改变以及心脏和心脏腔室的移动。在吸气之后，胸内压可以是相对较高的，这可以减小在心动周期期间流入心脏的腔室中的一个或多个中的血液的量。相反地，在呼气之后，胸内压可以是相对较低的，这可以在心动周期期间允许相对更多的血液进入心脏的腔室。流入和流出心脏的血液的量的这些差异和由于胸内压的变化而引起的心脏或心脏腔室的任何移动可以被包含在加速度计信号中。
图2—4描绘了可以促进LCP 100确定呼吸速率的示例性加速度计数据和已处理加速度计数据。图2描绘了在一段时间内获取的原始加速度计数据200。在这种情况下，原始加速度计数据200表示在许多心动周期内捕捉的加速度计数据。原始加速度计数据200可以表示当LCP 100被植入于患者的心脏腔室内时从LCP 100的加速度计输出的信号。
为了帮助确定呼吸速率，LCP 100可以以任何适当方式处理原始加速度计数据200。在至少一些示例中，LCP 100可以通过确定如图3中所示且用绝对值数据300表示的原始加速度计数据200的绝对值而开始。然后，LCP 100可以确定绝对值数据300的积分信号400或积分。在一些情况下，LCP 100可以确定每个心动周期内的绝对值数据300的积分信号400。LCP 100可以基于例如R波峰值的定位来识别每个心动周期。积分信号400描绘了绝对值数据3000的此类积分信号可以看起来像什么。
在确定积分信号400之后，LCP 100可以直接地根据积分信号400来确定一个或多个呼吸速率。作为一个示例，LCP 100可以确定呼气时间，其被识别为呼气时间403a-b。为了发现呼气时间，LCP 100可以确定积分信号400的峰值401中的哪一个表示局部最大值。例如，LCP 100可以确定峰值401b具有比分别地刚好在401b之前且刚好在峰值401b之后发生的峰值401a或401c中的任一个更大的最大值。因此，LCP 100可以确定呼气时间403a的开始与峰值401b对准。使用类似方法，LCP 100可以确定403b处的另一呼气时间的开始。LCP 100可以将六十秒除以两个连续呼气时间(呼气时间403a和403b)之间的时间差，以确定呼吸速率。例如，如果呼气时间403a和403b分离两秒，则LCP 100可以将呼吸速率确定为是每分钟30个呼吸。当然，在一些示例中，LCP 100可以基于识别出的局部最小值来确定呼吸速率。LCP 100可以以类似于LCP 100如何可以确定局部最大值的方式来确定局部最小值的时间，除了LCP 100可以识别具有比其他附近峰值低的值的峰值之外。
在一些情况下，LCP 100可以采用对上述方法的一个或多个增强。例如，LCP 100可以只有在以下情况时才确定对应于局部最大值的峰值401中的一个与呼气时间的开始相对应：当识别出的峰值401不在被确定为是局部最大值的先前峰值的阈值时间内时。例如，着眼于积分信号400，虽然峰值401d是局部最大值，但峰值401d在局部最大值峰值401e的消隐时段402内发生。因此，LCP 100可以不将峰值401d视为对应于呼气时间的开始。LCP 100可以在每次确定呼气时间的开始之后将消隐时段402重置。消隐时段402可以帮助使所确定的呼吸平滑，并且帮助确保呼吸速率不会显著地受到伪像的影响，该伪像影响来自除吸气和呼气之外的源的加速度计信号。在一些情况下，消隐时段402的范围可以在从四分之一秒至一秒或以上的任何位置。在一些情况下，LCP 100402可以基于最后的已知良好呼吸速率或预期呼吸速率来调整消隐时段402。另外，在一些情况下，LCP 100 402可以例如基于一个或多个其他感测到的信号来调整消隐时段402。消隐时段402可以随着呼吸速率增加而被向下调整，并且反之亦然。
增强的另一示例包括如果识别出的局部最大值具有在最大值范围之外的最大值则不将局部最大值确定为对应于呼气时间的开始。例如，如果局部最大值具有大于最大值范围的值，则LCP 100可以不将局部最大值确定为对应于呼气时间的开始。在一些情况下，最大值范围可以是先前三个、五个、十个或任何其他适当数目的峰值的值的平均值。在其他情况下，最大值范围可以是最后一分钟内的最大峰值的平均值。在一些另外的情况下，最大值范围可以是最后一分钟内的最大峰值的平均值加或减标准偏差。可替代地，作为对应于峰值的最大值的最大值范围的替代，最大值范围可以对应于振幅，该振幅是用所识别峰值与先前或最后的谷值之间的距离而测量的。
在一些示例中，LCP 100可以确定总体呼吸速率，其为由五个连续对的呼气时间的计时的差确定的五个呼吸速率的移动平均数。然而，用来确定总体呼吸速率的呼吸速率的精确数目在其他示例中可以不同。在替换情况下，总体呼吸速率可以是最近确定的呼吸速率。这些仅仅是LCP 100如何可以基于积分信号400来确定总体呼吸速率的一些示例。
一旦LCP 100已确定了总体呼吸速率，LCP 100可以确定是否要调整LCP100正在递送电刺激脉冲的速率。在一些情况下，LCP 100可以使用阈值来确定电刺激递送的适当速率。作为一个示例，LCP 100可以具有存储在存储器中的许多呼吸速率阈值，并且每个呼吸速率阈值可以与电刺激递送的不同速率相关联。随着呼吸速率上升至每个呼吸速率阈值以上或者下降至等于每个呼吸速率阈值或其以下，LCP 100可以基于与适当阈值相关联的速率来调整电刺激脉冲的递送速率。作为一个示例，LCP 100可以具有每分钟十个呼吸、每分钟二十个呼吸以及每分钟三十个呼吸的呼吸速率阈值，并且每分钟二十个呼吸的呼吸速率阈值与每分钟七十个刺激脉冲(例如70次搏动/分钟)的电刺激的递送速率相关联。在此类示例中，虽然总体呼吸速率大于每分钟二十个呼吸且小于或等于每分钟三十个呼吸，但LCP100可以以每分钟七十个脉冲的速率递送电刺激脉冲。一旦LCP 100确定总体呼吸速率已上升至每分钟三十个呼吸的呼吸速率阈值以上，LCP 100就可以将电刺激脉冲的递送速率增加至与每分钟三十个呼吸的呼吸速率阈值相关联的速率，例如每分钟九十次搏动(例如90次搏动/分钟)。以这种方式，LCP 100可以基于总体呼吸速率来调整电刺激脉冲的递送速率。
在某些替换实施例中，LCP 100可以基于与总体呼吸速率有关的增益因数来调整电刺激脉冲的递送速率。例如，增益因数可以是被乘以呼吸速率与基线呼吸速率相比的百分比变化的因数。作为一个示例，基线呼吸速率可以是每分钟十个呼吸。虽然总体呼吸速率是每分钟十个呼吸，但LCP 100可以例如以每分钟六十个脉冲(例如60次搏动/分钟)的速率递送电刺激脉冲。如果总体呼吸速率上升至每分钟二十个呼吸，则总体呼吸速率的变化是百分之一百。如果增益因数被设置成0.5，则LCP 100然后可以将电刺激脉冲的递送速率增加50％，至每分钟九十个脉冲(例如90次搏动/分钟)。应理解的是，0.5的增益系数仅仅被用作示例。增益因数可以是任何适当数目，其在患者之间可以改变。在其他情况下，增益因数可以与总体呼吸速率的相对变化(例如在最近总体呼吸速率与新确定的且不同的总体呼吸速率之间)有关。在至少一些实施例中，LCP 100可以具有在LCP 100调整电刺激递送的速率之前必须达到的总体呼吸速率的最小变化阈值。
无论LCP 100采用什么特定方法来调整电刺激脉冲的递送速率，LCP 100都可以具有编程的最大和最小速率。例如，即使用来调整电刺激脉冲的递送速率的方法将促使LCP100将电刺激脉冲的递送速率调整至最大阈值以上，LCP100也可以仅以最大速率递送电刺激脉冲。此外，即使用来调整电刺激脉冲的递送速率的方法将促使LCP 100将电刺激脉冲的递送速率调整至最小阈值以下，LCP 100也可以仅以最小速率递送电刺激脉冲。
在一些替换或附加实施例中，LCP 100可以在确定呼吸速率之前处理积分信号400。例如，LCP 100可以使积分信号400通过低通滤波器。图5中所示的说明性已滤波信号500表示低通滤波积分信号400之后的输出。已滤波信号500的峰值和谷值(例如峰值501和503及谷值505)可以分别地表示患者的吸气和呼气。在一个示例中，LCP 100可以通过取已滤波信号500的一阶导数并找到过零点来确定已滤波信号500的偏转(inflection)的计时。然后，可以使用两个峰值(或两个谷值)之间的计时的差来确定呼吸速率。例如，LCP 100可以取时间502a与时间502c之间的计时的差，并且用六十除以结果得到的差以确定每分钟的呼吸中的呼吸速率。
替换实施例可以以与相对于图2-5所述的不同的方式来处理原始加速度计数据200。例如，LCP 100可以直接地对原始加速度计数据200应用低通滤波器。LCP 100可以使用具有例如在0.3Hz与0.7Hz之间的拐角频率的滤波器，并且在一些示例中，LCP 100可以使用具有0.5Hz的拐角频率的滤波器。在此类实施例中，结果得到的已滤波信号可以看起来类似于已滤波信号500。在这些情况下，并且作为一个示例，LCP 100可以找到已滤波信号的一阶导数的过零点以找到拐点，并且可以使用那些拐点的计时来确定呼吸速率。
在替换实施例中，作为确定呼吸速率的替代，LCP 100可以基于信号(诸如已滤波信号500)的频率来调整电刺激脉冲的递送速率。例如，随着患者的呼吸速率增加，已滤波信号500的频率分量的相对功率可以朝着较高频率偏斜。因此，在确定已滤波信号500的频率分量的相对功率的变化之后，LCP 100可以基于那些确定出的变化来调整电刺激脉冲的递送速率。在一些情况下，这可以是不那么计算密集的和/或可以产出关于患者的当前呼吸的更准确数据。
在其他附加或替换实施例中，LCP 100可以以固定速率(例如在心动周期中的固定点处)对加速度计信号进行采样。在一些示例中，LCP 100可以在对应于感测到的R波的时间处对加速度计信号进行采样。例如，LCP 100可以使用峰值检测器或一个或多个其他技术来确定感测到的心电信号中的R波的发生。LCP100然后可以当LCP 100确定R波的发生时对加速度计信号进行采样。虽然，在其他实施例中，LCP 100可以在心动周期中的其他固定点处对加速度计信号进行采样。此采样的加速度计信号可以被LCP 100以类似于相对于已滤波信号500描述的方式例如在确定呼吸速率和/或相对潮气量(如本文所述)时使用。
应理解的是，虽然以上描述是围绕基于加速度计数据来确定呼吸速率，但可以使用其他信号来确定呼吸速率。例如，LCP 100可以使用ECG数据来确定呼吸速率。当LCP 100被植入于心脏的腔室内时，LCP 100可以经由感测放大器等来感测例如用ECG表示的心内电信号。ECG信号的R波的相对量值可以随着心脏腔室的体积的变化而波动，并且心脏腔室的体积可以根据胸内压而波动——诸如由于患者的肺容量的变化。在一些情况下，此类心内压力的变化可以用来确定呼吸速率。
在一些情况下，LCP 100可以使用除呼吸速率之外的参数来调整电刺激脉冲的递送速率。例如，LCP 100可以使用心音来调整电刺激脉冲的递送速率。增加的心音并且特别地增加的S1心音可以是心脏的增加收缩性的指示。增加的心音的示例可以包括心音信号的振幅的增加或信号峰值的持续时间的增加。心脏的增加的收缩性可以指示对增加的心脏输出的需要。因此，随着心音增加，LCP 100可以增加电刺激脉冲的递送速率，例如以与相对于呼吸速率所述的类似的方式。在一些情况下，LCP 100可以使用温度来调整电刺激脉冲的递送速率。例如，增加的血液温度可以指示身体的增加的代谢活动和因此的对增加的心脏输出的需要。
在一些情况下，LCP 100可以使用相对潮气量参数来调整电刺激脉冲的递送速率。例如，LCP 100可以根据积分信号400或者在其他示例中的已滤波信号500来确定相对潮气量参数。如在图4中可以看到的，在LCP 100确定相对潮气量参数的情况下，LCP 100可以确定作为局部最小值的峰值401，例如峰值401f。LCP 100可以以与LCP 100如何可以确定作为局部最大值的峰值401类似的方式确定作为局部最小值的峰值401。例如，LCP 100可以识别其值低于紧邻先前和后续峰值的峰值。LCP 100然后可以确定具有值407b的峰值401f与具有值407a的先前局部最大值峰值(诸如图4中的峰值401b)之间的值的差。LCP 100可以使用值407a与407b之间的值的此差来提供与相对潮气量参数有关的度量。相对潮气量的增加或相对潮气量的变化性的增加可以指示增加的对心脏输出的需要。因此，LCP 100可以跟踪相对潮气量如何随时间推移而改变，并且可以基于相对潮气量的变化来调整电刺激脉冲的递送速率，例如可能地以与呼吸速率类似的方式。在LCP 100进一步对积分信号400进行低通滤波或者直接地对原始加速度计数据200进行低通滤波以产生已滤波信号500的情况下，LCP 100可以根据已滤波信号500来确定相对潮气量参数。例如，LCP 100可以确定峰值501与谷值505之间的值507a和507b的差。LCP 100可以使用这个确定出的差作为与相对潮气量参数值有关的度量。
图6描绘了用于装置(诸如LCP 100)如何可以调整电刺激脉冲的递送速率的一般方法600。说明性方法600从使用被配置为植入于心脏上或心脏的腔室内的无引线心脏起搏器(LCP)以第一递送速率向心脏递送电刺激而开始，如在601处所指示的。LCP可以是诸如相对于图1所述的LCP 100之类的LCP。接下来，方法600可以用LCP来感测第一信号，如在603处。如上所述，信号可以是诸如加速度计信号、ECG、心音信号、压力信号或温度信号等信号。接下来，方法600可以至少部分地基于第一感测信号来确定是否要改变电刺激的递送速率，如在605处。如所述，在一些情况下，LCP可以基于第一感测信号来确定参数(诸如呼吸速率)，并且可以基于所确定的参数来调整电刺激脉冲的递送速率。在一些情况下，LCP可以确定相对潮气量参数、心音参数和/或心内压参数。在LCP基于第一感测信号来确定参数的情况下，LCP可以作为第一感测信号替代或除其之外至少部分地基于所确定的参数来进一步确定是否要改变电刺激的速率。例如，LCP可以响应于所确定的参数上升至阈值以上或下降至其以下(视情况而定)来确定要改变电刺激的递送速率。作为一个说明性示例，LCP可以响应于确定呼吸速率参数上升至阈值以上而确定要增加电刺激的递送速率，从而指示对心脏输出的增加的需要。在确定要改变电刺激的递送速率之后，方法600可以用LCP以第二递送速率向心脏递送电刺激，如在607处。例如，如果第一感测信号或确定出的参数指示对增加的心脏输出的需要，则LCP可以增加电刺激的递送速率。相反地，如果第一感测信号或确定出的参数并未指示对当前心脏输出的需要，则LCP可以减小电刺激的递送速率。
在一些情况下，LCP 100可以基于感测信号的组合来调整电刺激的递送速率。例如，LCP 100可以感测第一信号，并且基于感测到的第一信号来确定呼吸速率。除呼吸速率之外，LCP 100还可以进一步确定第二参数。在一些示例中，LCP 100还可以根据加速度信号来确定第二参数，例如相对潮气量参数。在其他示例中，LCP 100可以感测第二信号，例如心音信号、心内压信号和/或温度信号等，并且可以根据感测到的第二信号来确定第二参数。LCP 100可以确定心音参数、心内压参数和/或温度参数。在一些替换示例中，LCP 100可以基于感测到的第二信号来确定第二呼吸速率。
在确定第二参数之后，LCP 100可以使用所确定的呼吸速率和所确定的第二参数的组合来调整电刺激的递送速率。例如，LCP 100可以遵循根据图7的方法。图7描绘了LCP100可以遵循以便调整电刺激脉冲的递送速率的方法700的流程图。方法700从LCP 100确定出所确定的呼吸速率或第二所确定的参数中的第一个是否指示对增加的心脏输出的需要而开始，如在701处。例如，并且在一些情况下，所确定的呼吸速率或所确定的第二参数可以上升至相应阈值，或者在适当的情况下可以下降至相应阈值以下。所确定的呼吸速率或第二所确定参数上升至阈值以上或下降至阈值以下可以指示出对增加的心脏输出的需要。如果呼吸速率和第二所确定参数两者都未指示出对增加的心脏输出的需要，则LCP 100可以遵循步骤701的否(NO)分支，如707处所示的那样保持电刺激脉冲的当前递送速率，并且继续监视呼吸速率和所确定的第二参数直至在701处参数中的一个指示了对增加的心脏输出的需要为止。
在LCP 100确定出所确定的呼吸速率或所确定的第二参数指示出对增加的心脏输出的需要的情况下，LCP 100可以遵循步骤701的是(YES)分支。LCP100然后可以确定所确定的呼吸速率和第二所确定参数中的第二个是否指示对增加的心脏输出的需要，如在703处。如果LCP 100确定出所确定的呼吸速率和第二所确定参数中的第二个并未指示对增加的心脏输出的需要，则LCP 100可以遵循步骤703的NO分支，如707处所示的那样保持电刺激脉冲的当前递送速率，并且继续监视呼吸速率和所确定的第二参数直至在701处参数中的一个指示了对增加的心脏输出的需要为止。然而，如果LCP 100确定出所确定的呼吸速率和第二所确定参数中的第二个指示出对增加的心脏输出的需要，即所确定的呼吸速率和第二所确定的参数两者都指示了对增加的心脏输出的需要，则LCP 100可以调整电刺激脉冲的递送速率，如在705处。例如，LCP 100可以增加电刺激脉冲的递送速率。
虽然图7的示例性方法参考所确定的呼吸速率和第二所确定参数，但可设想的是可以使用任何两个(或更多)参数。例如，可以使用心音参数和相对潮气量参数。在一些情况下，可以不调整电刺激脉冲的递送速率，除非三个或更多参数指示出对增加的心脏输出的需要，或者三个参数中的两个指示出对增加的心脏输出的需要。这些仅仅是一些示例。
在一些情况下，LCP 100可以确定并监视两个参数，诸如如上所述的呼吸速率和第二所确定参数，但是仍仅基于所确定的呼吸速率来调整电刺激脉冲的递送速率。在一些情况下，如果LCP 100确定出所确定的呼吸速率和第二所确定参数两者指示对增加的心脏输出的需要，则LCP 100可以甚至进一步调整电刺激脉冲的递送速率。例如，如果所确定的呼吸速率和第二所确定参数中的一个指示对增加的心脏输出的需要，则LCP 100可以增加电刺激脉冲的递送速率。如果LCP 100确定出所确定的呼吸速率和第二所确定参数两者指示对增加的心脏输出的需要，则LCP 100可以甚至进一步增加电刺激脉冲的递送速率。在一些情况下，LCP 100可以具有被存储在存储器中的两个增益因数，并且可以在确定所确定的呼吸速率和第二所确定参数中的仅一个指示对增加的心脏输出的需要之后应用第一增益因数来调整电刺激脉冲的递送速率。LCP 100可以在所确定的呼吸速率和第二所确定参数两者指示对增加的心脏输出的需要之后应用第二增益因数来调整电刺激脉冲的递送速率，其中第二增益因数大于第一增益因数。当然，在此类示例中，如果LCP 100确定对所确定的呼吸速率和/或第二所确定参数中的第一个的进一步改变，则LCP 100可以进一步调整电刺激脉冲的递送速率。
在另一示例中，LCP 100可以依次使用多个参数来确定是否要调整电刺激脉冲的递送速率。例如，LCP 100可以首先确定呼吸速率参数是否改变。一旦LCP100已确定呼吸速率参数已改变，例如增加至阈值以上，则LCP 100然后可以将电刺激脉冲的递送速率增加至第一增加速率。一旦LCP 100正在以第一增加速率递送电刺激脉冲，那么LCP 100可以针对改变监视第二参数以进一步调整电刺激脉冲的递送速率。例如，LCP 100可以在确定是否要进一步调整电刺激脉冲的递送速率时针对改变监视相对潮气量。如果LCP 100确定相对潮气量参数的改变，例如在阈值以上的相对潮气量参数的增加，则LCP 100可以将电刺激脉冲的递送速率进一步增加至第二增加速率。当然，在其他示例中，所监视参数的序列的顺序可以是不同的。一般地，本公开设想包括按照任何顺序布置的任何数目和任何组合的参数的实施例。
虽然相对于当一个或多个参数指示对增加的心脏输出的需要时增加电刺激脉冲的递送速率来描述了用于调整速率的上述方法，但以类似方式，LCP 100可以在一个或多个参数并未指示对心脏输出的当前水平的需要时减小电刺激脉冲的递送速率。例如，当参数中的一个或多个下降至阈值以下或上升至阈值以上(在适当的情况下)时，其指示由当前心脏输出提供的较少需要，以及因此电刺激脉冲的当前递送速率较少需要。因此，LCP 100可以被配置成减小电刺激脉冲的递送速率以减少心脏输出。在一些实施例中，LCP 100可以使用多个所确定参数来帮助确定是否要减小电刺激脉冲的递送速率，例如以相对于用于增加电刺激脉冲的递送速率的图6所述的类似方式。
另外，虽然相对于呼吸速率和另一参数描述了用于调整电刺激脉冲的递送速率的上述方法，但在替换实施例中，LCP 100可以使用不包括呼吸速率的两个参数来确定是否要调整电刺激脉冲的递送速率。例如，LCP 100可以使用心音参数和相对潮气量参数。在其他情况下，LCP 100可以使用心内压参数和温度参数。一般地，LCP 100可以在确定是否要调整电刺激脉冲的递送速率时使用本文所述的参数的任何组合。在一些示例中，两个参数都可以是呼吸速率参数。然而，可以使用不同的信号源或使用不同的信号处理算法来确定两个呼吸速率参数。例如，LCP 100可以基于加速度计信号来确定第一呼吸速率参数并基于ECG信号或心内信号或另一感测信号(根据期望)来确定第二呼吸速率参数。在此类示例中，LCP100可以在调整电刺激脉冲的递送速率基于两个不同信号来考虑两个呼吸速率。
虽然先前并未明确地提及，但在LCP 100包括加速度计的情况下，加速度计可以是三轴加速度计。在LCP 100包括三轴加速度计的情况下，原始加速度计数据200可以是来自三轴加速度计的全部三个通道的总和、来自三个通道中的两个的总和，或者可以是三个通道中的仅一个。LCP 100然后可以继续进行以如本文所述地处理原始加速度计数据200。在一些情况下，LCP 100可以被配置为单独地对三轴加速度计的每个通道进行低通滤波。LCP100然后可以使用与模板信号最紧密相关的三个已滤波信号中的结果得到的已滤波信号。在一些情况下，模板信号可以类似于已滤波信号500。在其他示例中，用户可以查看三个已滤波信号中的每一个并将LCP 100编程为使用已滤波信号中的特定一个。
除了LCP 100可以如何操作相对于LCP 100在LCP 100包括三轴加速度计的情况下如何处理加速度计数据的差别之外，在一些实施例中，LCP 100可以改变LCP 100确定参数的一个或多个方式或者LCP 100用来调整电刺激脉冲的递送速率的步骤中的一个或多个。例如，基于三轴加速度计信号，LCP 100可能能够确定患者是具有仰卧还是直立位置。基于该确定，LCP 100可以启用或禁用速率适应性起搏。例如，如果患者处于仰卧位置，则LCP100可以禁用速率适应性起搏。在其他情况下，LCP 100可以基于患者是处于仰卧还是直立位置而改变LCP 100借以调整电刺激脉冲的递送速率的特定方法，或者甚至在确定要将电刺激脉冲的递送速率调整多少时所使用的增益因数。
可设想的是LCP 100可以包括一个或多个预编程参数。例如，LCP 100可以包括预编程呼吸速率阈值或者与其他参数相关联的阈值。另外，各种阈值可以与电刺激脉冲的一个或多个递送速率相关联。在其中LCP 100可以基于一个或多个增益因数来调整电刺激脉冲的递送速率的示例中，可以用一个或多个增益因数将LCP 100预编程。在一些情况下，这些预编程值中的一些或全部可以是可编程的且可改变的。例如，LCP 100可以能够与位于患者外部的编程装置通信。编程装置的用户(诸如医师)可以向编程装置中输入对一个或多个可编程值的改变。编程装置然后可以将已改变值传送至LCP 100，在那里已改变值覆写先前预编程值。另外，在一些示例中，可以用用于确定是否要调整电刺激脉冲的递送速率的多个方法对LCP 100进行预编程。LCP 100可以每次根据方法中的一个进行操作，无论哪个方法是活动方法。在一些示例中，编程装置可以能够与LCP100通信以改变活动方法或者甚至传送新方法以便存储到LCP 100的存储器中。
在一些情况下，可以不时地对LCP 100进行校准。例如，可以在植入于患者体内之后或者在后续的后续到诊所就诊期间对LCP 100进行校准。为了对LCP100进行校准，可以将患者连接至外部呼吸传感器，诸如肺活量计或呼吸感应体积描记器等。可以将从这些呼吸仪器收集的信号与LCP 100的所确定的呼吸速率相比较。在由LCP 100确定的呼吸速率与一个或多个呼吸仪器的输出之间存在差异的情况下，用户(诸如医师)可以对被LCP 100用来确定呼吸速率的特定算法进行校准。例如，用户可以改变LCP 100借以确定呼吸速率的特定算法—例如，用户可以将LCP 100从使用本文所述方法中的一个切换至本文所述的方法中的另一个。可替代地，用户可以改变LCP 100借以进行操作的当前方法的特定参数。例如，在LCP 100采用一个或多个滤波器的情况下，用户可以调整滤波器的拐角频率。可替代地，在LCP 100包括多个电极的情况下，用户可以调整LCP 100借以感测心电信号的特定电极。在其他实施例中，用户可以改变LCP 100的其他方面或者LCP 100借以确定呼吸速率的特定方法。
在其中对LCP 100进行校准的一些示例中，用户可以采用两点校准过程。例如，用户可以在患者处于静止状态的同时对LCP 100进行校准。用户然后可以在患者正在经历身体活动的同时(诸如在患者正在行走或跑步或爬楼梯等)进一步对LCP 100进行校准。
本领域的技术人员将认识到除在本文中描述和设想的特定实施例之外可用多种形式来表明本公开。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，其他实施例可以包括将所述功能分布在甚至比本文所述更多模块上的附加模块。另外，其他实施例可将所述功能合并成较少的模块。
虽然已相对于少于全部的实施例描述了各种特征，但本公开设想可在任何实施例上包括那些特征。此外，虽然本文所述的实施例已省略了各种所述特征的某些组合，但本公开设想包括每个所述特征的任何组合的实施例。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进行形式和细节方面的修改。

Claims (14)

1.一种用于向心脏递送电刺激的医疗装置，该装置包括：
外壳，其被配置为植入于心脏上或心脏的腔室内；
一个或多个电极，其被连接至所述外壳；以及
控制器，其被设置于所述外壳内，所述控制器被配置为：
感测第一信号，
确定感测到的第一信号的绝对值，
确定感测到的第一信号的绝对值在患者的多个心动周期的每个心动周期上的积分信号，
至少部分地基于积分信号来确定呼吸速率，以及
至少部分地基于所确定的呼吸速率来调整由医疗装置进行的电刺激的递送的速率。
2.根据权利要求1所述的医疗装置，其中，所述控制器被进一步配置为：
至少部分地基于感测到的第一信号来确定相对潮气量参数；以及
至少部分地基于所确定的呼吸速率和所确定的相对潮气量参数两者来调整由医疗装置进行的电刺激的递送的速率。
3.根据权利要求1所述的医疗装置，其中，感测到的第一信号是加速度计信号。
4.根据权利要求1-3中的任一项所述的医疗装置，其中，所述控制器被进一步配置为在心脏的心动周期的固定点处对第一信号进行采样。
5.根据权利要求1-3中的任一项所述的医疗装置，其中，所述控制器被配置为如果所确定的呼吸速率上升至呼吸阈值以上则调整由医疗装置进行的电刺激的递送的速率。
6.根据权利要求1-3中的任一项所述的医疗装置，其中，所述控制器被配置为如果所确定的呼吸速率下降至等于呼吸阈值或其以下则调整由医疗装置进行的电刺激的递送的速率。
7.根据权利要求1-3中的任一项所述的医疗装置，其中，所述控制器进一步被配置成：
感测第二信号；以及
至少部分地基于所确定的呼吸速率、所确定的潮气量和第二感测信号来调整由医疗装置进行的电刺激的递送的速率。
8.根据权利要求7所述的医疗装置，其中，所述第二感测信号是心音信号。
9.根据权利要求7所述的医疗装置，其中，所述控制器被配置为如果呼吸速率上升至呼吸阈值以上且第二感测信号上升至第二阈值以上则增加由医疗装置进行的电刺激的递送的速率。
10.根据权利要求1-3中的任一项所述的医疗装置，其中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被配置为确定感测到的第一信号的绝对值。
11.根据权利要求1所述的医疗装置，其中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为用低通滤波器对积分信号进行滤波。
12.根据权利要求11所述的医疗装置，其中，所述低通滤波器具有在0.3Hz与0.7Hz之间的拐角频率。
13.根据权利要求12所述的医疗装置，其中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被进一步配置为确定被低通滤波的信号的一阶导数的过零点。
14.根据权利要求1-3中的任一项所述的医疗装置，其中，为了至少部分地基于感测到的第一信号来确定呼吸速率，控制器被配置为用低通滤波器对所述第一信号进行滤波。
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