CN109952128B - 用于活动水平起搏的*** - Google Patents
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Abstract
公开了用于起搏患者心脏的***、设备和方法。示例性方法可包括使用相对于患者心脏固定的可植入医疗设备的运动传感器确定患者的运动水平,以及至少部分地基于患者的运动水平设定起搏频率。可通过例如将在当前心跳期间由运动传感器感测的运动水平与和一个或多个先前心跳相关联的运动水平进行比较来确定患者的运动水平。在那些在内在发起的心跳和起搏发起的心跳之间转变的心跳期间,在运动水平测量结果中可能出现噪声。可将各种技术应用于运动水平测量结果以帮助减少这种噪声的影响。
Description
相关申请的交叉引用
本申请要求于2016年10月31日提交的美国临时专利申请序列号62/415,132的权益,其公开通过引用并入于此。
技术领域
本公开总体涉及用于向患者递送起搏治疗的***、设备和方法,并且更具体地,涉及用于基于患者的活动水平调制起搏治疗的***、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。在一些情况下,这样的设备可以基于患者的活动水平来调制递送的起搏治疗,这有时被称为频率响应起搏。
发明内容
本公开总体上涉及用于向患者递送起搏治疗的***、设备和方法,并且更具体地涉及用于基于患者的活动水平而调制起搏治疗的***、设备和方法。
在说明性实施例中,可植入在患者心脏内的可植入医疗设备(IMD)可以包括:两个或更多个传感器,其包括运动传感器;和控制器,其可操作地耦合到两个或更多个传感器。控制器可以使用一个或多个传感器来识别多个心跳,多个心跳中的每一个具有收缩阶段(systole phase)和舒张阶段(diastole phase)。控制器还可以将多个心跳中的两个或更多心跳个中的每一个识别为内在发起的心跳或起搏发起的心跳。然后,针对内在发起的心跳,控制器可以在内在发起的心跳的收缩阶段期间使用运动传感器(例如,加速度计)来识别IMD的运动水平,并且将识别出的IMD的运动水平与针对一个或多个先前内在发起的心跳而识别出的IMD的运动水平进行比较,并且还可以至少部分地基于该比较来识别患者的运动水平。针对起搏发起的心跳,控制器可以在起搏发起的心跳的收缩阶段期间使用运动传感器来识别IMD的运动水平,并且将识别出的IMD的运动水平与针对一个或多个先前起搏发起的心跳而识别出的IMD的运动水平进行比较,并且可以至少部分地基于该比较来识别患者的运动水平。至少部分地基于患者的识别出的运动水平,控制器可以为IMD设定起搏频率参数。
另外地或可替代地,对于第一说明性实施例,针对紧接起搏发起的心跳之后的内在发起的心跳,控制器可以被配置为不基于心跳来识别患者的运动水平。
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,针对紧接内在发起的心跳之后的起搏发起的心跳,控制器可以被配置为不基于心跳来更新患者的运动水平。
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,针对内在发起的心跳,控制器可以被配置为:如果紧接在前的心跳是内在发起的心跳,则将识别出的IMD的运动水平与针对紧接在前的心跳而先前识别出的IMD的运动水平进行比较,并且如果紧接在前的心跳是起搏发起的心跳,则要么在内在发起的心跳的收缩阶段期间不使用运动传感器来识别IMD的运动水平,要么忽略识别出的IMD的运动水平。
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,针对起搏发起的心跳,控制器可以被配置为:如果紧接在前的心跳是起搏发起的心跳,则将IMD的识别出的运动水平与针对紧接在前的心跳而先前识别出的IMD的运动水平进行比较,并且如果紧接在前的心跳是内在发起的心跳,则要么在起搏发起的心跳的收缩阶段期间不使用运动传感器来识别IMD的运动水平,要么忽略识别出的IMD的运动水平。
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:针对内在发起的心跳,将IMD的识别出的运动水平与作为针对两个或更多个先前内在发起的心跳而识别出的IMD的运动水平的平均值的IMD的平均运动水平进行比较;并且针对起搏发起的心跳,将IMD的识别出的运动水平与作为针对两个或更多个先前起搏发起的心跳而识别出的IMD的运动水平的平均值的IMD的平均运动水平进行比较。
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,其中针对内在发起的心跳,IMD的平均运动水平是加权平均值,并且针对起搏发起的心跳,IMD的平均运动水平是加权平均值。
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,其中两个或更多个先前内在发起的心跳和两个或更多个先前起搏发起的心跳全部都落入向后延伸(extend back)预定时间量的移动时间窗口内。
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:识别患者心脏的当前心率并且至少部分地基于识别出的当前心率而将当前心跳识别为对应于两个或更多个心率范围中的一个。此外,针对内在发起的心跳,控制器可以将识别出的IMD的运动水平与针对已经被识别为对应于相同心率范围的一个或多个先前内在发起的心跳而识别出的IMD的运动水平进行比较,并且至少部分地基于该比较来识别患者的运动水平。针对起搏发起的心跳,控制器可以将识别出的IMD的运动水平与针对已经被识别为对应于相同心率范围的一个或多个先前起搏发起的心跳而识别出的IMD的运动水平进行比较,并且至少部分地基于该比较来识别患者的运动水平。
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将多个心跳中的每一个识别为内在发起的心跳、起搏发起的心跳或融合心跳;并且其中针对融合心跳,不基于该心跳来识别患者的运动水平。
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,运动传感器包括三轴加速度计,并且两个或更多个传感器中的另一个包括两个或更多个电极,其被配置为感测患者心脏的电信号。
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,IMD是无引线心脏起搏器。
在另一个说明性实施例中,一种用于使用植入在患者心脏内的运动传感器来识别患者的活动水平的方法包括:识别多个心跳,多个心跳中的每一个具有收缩阶段和舒张阶段;和将多个心跳中的两个或更多个心跳中的每一个识别为内在发起的心跳或起搏发起的心跳。针对内在发起的心跳,该方法包括:在内在发起的心跳的收缩阶段期间使用运动传感器来识别IMD的运动水平,并且将识别出的IMD的运动水平与针对一个或多个先前内在发起的心跳而识别出的IMD的运动水平进行比较,并且至少部分地基于该比较来识别患者的活动水平。针对起搏发起的心跳,该方法包括:在起搏发起的心跳的收缩阶段期间使用运动传感器来识别IMD的运动水平,并且将IMD的识别出的运动水平与针对一个或多个先前起搏发起的心跳而识别出的IMD的运动水平进行比较,并且可以至少部分地基于该比较来识别患者的活动水平。
另外地或可替代地,第二说明性实施例还可以包括,其中针对紧接起搏发起的心跳之后的内在发起的心跳,不基于该心跳来识别患者的活动水平。
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,其中针对紧接内在发起的心跳之后的起搏发起的心跳,不基于该心跳来识别患者的活动水平。
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,以起搏频率对患者的心脏进行起搏,其中起搏频率至少部分地基于患者的识别出的活动水平。
在又另一个说明性实施例中,可植入在患者心脏内的无引线心脏起搏器(LCP)包括:壳体;相对于壳体固定的两个或更多个电极,两个或更多个电极被配置为感测患者心脏的电信号;位于壳体内部的加速度计;以及位于壳体内部并可操作地耦合到两个或更多个电极和加速度计的电路。电路可以使用两个或更多个电极来识别多个心跳,多个心跳中的每一个具有收缩阶段和舒张阶段,并且还可以将多个心跳中的两个或更多个心跳中的每一个识别为内在发起的心跳或起搏发起的心跳。针对内在发起的心跳,电路可以在内在发起的心跳的收缩阶段期间使用加速度计来识别LCP的运动水平,并且将识别出的LCP的运动水平与针对一个或多个先前内在发起的心跳但不针对任何先前起搏发起的心跳而识别出的LCP的运动水平进行比较,并且至少部分地基于该比较来识别患者的活动水平。然后,电路可以以至少部分地基于识别出的患者的活动水平的起搏频率而对患者的心脏进起搏。
另外地或可替代地,对于第三说明性实施例,针对紧接起搏发起的心跳之后的内在发起的心跳,电路可以被配置为不基于该心跳来识别患者的活动水平。
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,针对起搏发起的心跳,电路还可以被配置为,在起搏发起的心跳的收缩阶段期间使用加速度计来识别LCP的运动水平,并且将识别出的LCP的运动水平与针对一个或多个先前起搏发起的心跳但不针对任何先前内在发起的心跳而识别出的LCP的运动水平进行比较,并且可以至少部分地基于该比较来识别患者的活动水平。
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,针对内在发起的心跳,电路可以被配置为,将识别出的LCP的运动水平与作为针对两个或更多个先前内在发起的心跳而识别出的LCP的运动水平的平均值的LCP的平均运动水平进行比较;并且针对起搏发起的心跳,电路可以被配置为将识别出的LCP的运动水平与作为针对两个或更多个先前起搏发起的心跳而识别出的LCP的运动水平的平均值的LCP的平均运动水平进行比较,其中两个或更多个先前内在发起的心跳和两个或更多个先前起搏发起的心跳全部都落入向后延伸预定时间量的移动时间窗口内。
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结合使用的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***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***的示意图;
图5描绘了示出心电信号和用于内在发起的心跳和起搏发起的心跳的说明性运动传感器信号迹线(trace)的曲线图。
图6描绘了用于为LCP设定起搏频率参数的说明性技术的示意流程图;
图7描绘了用于为LCP设定起搏频率参数的说明性技术的示意流程图;
图8描绘了用于利用心率范围分类为LCP设定起搏频率参数的说明性技术的示意流程图;
图9描绘了用于利用偏移为LCP设定起搏频率参数的说明性技术的示意流程图;
图10描绘了用于利用校准窗口为LCP设定起搏频率参数的说明性技术的示意流程图;和
图11A-11C描绘了多个心跳的说明性平均原始加速度计数据的曲线图。
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。
本公开描述了用于根据患者的运动水平修改起搏脉冲的递送的***、设备和方法。例如,本公开的设备可以被配置为确定患者的运动水平。然后,设备可以根据确定的运动水平调整起搏脉冲的递送频率(rate)。作为一个示例,相对于在较高的患者运动的时段期间的起搏脉冲的递送频率,设备可以在较低的患者运动的时段期间减慢起搏脉冲的递送频率。
图1是可植入医疗设备(IMD)的概念性示意性框图,所述可植入医疗设备诸如是可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说明性无引线心脏起搏器(LCP)。示例电刺激治疗可包括心动过缓起搏、频率响应起搏治疗、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LCP 100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。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例如以频率自适应起搏产生电刺激脉冲的频率。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(例如频率自适应起搏)调整起搏频率。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产生电刺激脉冲的频率。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)帮助频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LCP 100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产生具有变化参数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递送被设计用于以规则间隔捕获患者心脏的起搏脉冲,以帮助防止患者的心脏低于预定阈值。
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频率递送起搏脉冲,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频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***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整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。
在另外的实施例中,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可向LCP 100提供电源以用于其工作。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MD 200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,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***和通信路径的实施例,医疗设备***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***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***300的一个或多个设备进行编程的外部编程器设备。
***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***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***300的一个或多个其他设备306和310。在一些情况下,***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)。***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***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,***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,***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,***300的设备可具有允许这种传导的通信的组件。例如,***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***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,***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***400。例如,***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,***400的设备可被配置为确定***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***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***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***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***的一个示例实施例,该医疗设备***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***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***可包括植入心脏内的另外的LCP。另一个示例性医疗设备***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***400的许多其他医疗设备***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。
在一些实施例中,LCP 100可被配置为以一种或多种模式工作。在每种模式内,LCP100可以以稍微不同的方式工作。例如,在第一模式中,LCP 100可被配置为感测某些信号并且/或者从所感测的信号中确定某些参数。在第二模式中,LCP 100可被配置为感测至少一些不同的信号并且/或者确定与在第一模式中的参数至少一些不同的参数。在至少一种模式中,LCP 100可被配置为确定患者的运动水平并基于所确定的患者的运动水平来调制电刺激治疗的递送。为了便于描述,包括LCP 100被配置为确定患者的运动水平并且基于所确定的患者的运动水平调制电刺激治疗的递送的模式可被称为运动感测模式。其他模式可包括一个或多个编程和/或治疗模式,并且LCP 100可以同时参与多种模式。
在一些实施例中,LCP 100可包括治疗模式,其中LCP 100作为起搏器工作并且向心脏递送电刺激治疗诸如电刺激脉冲,以为患者驱动特定心率。LCP 100可被配置为调制LCP 100递送电刺激治疗的频率,以便为患者驱动不同的心率。例如,LCP 100可被配置为以频率自适应方式递送电刺激,如本文所述。在这些实施例的至少一些中,LCP 100可包括运动感测模式,其可以是特定治疗模式或可以修改治疗模式。在运动感测模式中,LCP 100可基于所确定的患者运动水平来调制电刺激治疗的递送频率。
在一些情况下,LCP 100可使用LCP 100中的运动传感器(例如,加速度计)来确定患者的运动水平。使用LCP 100中的运动传感器(例如,加速度计)来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,还包括跳动的心脏的运动。此外,跳动的心脏的运动水平对于内在发起的心跳相对于起搏发起的心跳可以是不同的。
已经发现,当连续心跳从内在发起的心跳切换或转变为起搏发起的心跳和/或从起搏发起的心跳切换或转变为内在发起的心跳时,可存在患者的运动水平(例如,活动水平)中的噪声水平。当至少部分地基于患者的运动水平(例如,活动水平)调整起搏治疗(例如,电刺激治疗)时,这种噪声可导致在不需要时提高患者的心率和/或可导致在需要时不提高患者的心率。当心跳在内在发起的心跳和起搏发起的心跳之间转变时,LCP 100中的运动传感器的运动水平测量结果中的噪声在图5的迹线中示出。图5描绘了曲线图450,其示出了当LCP 100附接到患者心脏的壁时来自LCP 100的运动传感器(例如加速度计)的多个信号迹线。曲线图450的x轴是时间t。电信号452是由LCP 100的电极感测的说明性心电信号(例如,描绘心跳)。运动信号454是由LCP 100的机械感测模块108的加速度计感测的示例信号(假设两个连续的内在发起的心跳)。运动信号456是由LCP 100的机械感测模块108的加速度计感测的示例信号(假设两个连续的起搏发起的心跳)。运动信号454、456示出了LCP100的运动水平测量结果。迹线458示出了示例运动信号454和456,其被绘制以示出它们随时间的相对幅度。当患者处于相对静止位置(例如很少或没有患者活动)时,可使用LCP 100取得图5中的示例信号迹线。
图5中的线A-A表示可取得来自机械感测模块108(例如,来自其运动传感器)的读数的时间。在一些情况下,与线A-A相关联的时间可以相对于电信号452中的识别出的心跳。在一个示例中,线A-A可在检测到心跳之后的预定时间设定,诸如50毫秒(ms)、100ms、150ms、200ms、250ms、300ms和/或其间的其他时间段,大于300ms,或小于50ms。在一些情况下,可期望的是在心动周期的收缩阶段和舒张阶段中的一个期间从机械感测模块108一致地取得测量结果。例如,当患者的心脏处于收缩阶段(例如,当心脏收缩)并且心脏的加速度可以基本恒定时,可从机械感测模块108取得测量结果。在一个示例中,在心跳发起后的200ms处或约200ms处从机械感测模块108取得测量结果可以得出在心动周期的收缩阶段期间并且当心脏处于基本上恒定的加速度时(例如,图5中的恒定收缩和相对平坦)的测量结果。
从图5中的迹线458可以看出,运动信号454和456在线A-A处具有不同的值。线A-A处的运动信号454和456之间的这种差可以被认为是当连续心跳不是由内在节律和起搏节律中的相同一个发起时从机械感测模块108取得的测量结果中的“噪声”的图形表示。本文中的技术可以单独地和/或组合地使用,以当响应于患者的运动水平确定是否修改起搏治疗时帮助校正该“噪声”。
在频率自适应起搏中,可以针对每个心跳确定LCP 100(例如,IMD)的运动水平。然后,可以通过将针对当前心跳的LCP 100的运动水平与和一个或多个先前的心跳相关联的一个或多个运动水平进行比较来识别其中植入LCP 100的患者的运动水平(例如,活动水平)。差可归因于患者的活动水平。然而,当心跳在由不同节律(例如,内在节律和起搏节律)发起的心跳之间转变时,可能发生上述“噪声”,导致LCP 100的运动水平的大于预期的变化,其可以不准确地指示患者的活动水平上升并且不必要地提高心脏的起搏频率。
图6描绘了用于至少部分地基于患者的识别出的运动水平来设定植入患者心脏中的LCP 100的起搏频率参数的说明性方法500。在说明性方法500中,可例如通过植入的LCP100的电感测模块106来识别502多个心跳。LCP 100的处理模块110或其他处理模块(例如,位于或远离LCP)可识别出504——识别出的心跳是内在发起的还是起搏发起的。处理模块110可通过分析心跳的电信号452的形态、运动信号454、456的形态和/或使用任何其他合适的技术来区分内在发起的心跳、起搏发起的心跳和融合跳动。在一些情况下,电信号452可与用于内在发起的心跳的电信号模板、用于起搏发起的心跳的电信号模板和用于融合跳动的电信号模板进行比较,并且识别出电信号452最匹配哪个电信号模板。同样地,可将运动信号与用于内在发起的心跳的运动信号模板、用于起搏发起的心跳的运动信号模板和用于融合跳动的运动信号模板进行比较,并且识别出运动信号最匹配哪个运动信号模板。这些只是示例。
针对内在发起的心跳,处理模块110可识别506来自LCP 100(例如,IMD)的机械感测模块108(例如,来自其运动传感器)的运动水平测量结果,并且将针对当前内在发起的心跳的识别出的LCP 100的运动水平与针对一个或多个先前的内在发起的心跳的LCP 100的运动水平进行比较508。可在心动周期的收缩阶段期间取得运动水平测量结果,但这不是必需的。至少部分地基于比较,处理模块110或其他处理模块可识别510其中植入LCP 100的患者的运动水平。至少部分地基于识别出的患者的运动水平,处理模块110或其他处理模块可设定518用于LCP 100的起搏频率参数。
针对起搏发起的心跳,处理模块110可识别512来自LCP 100(例如,IMD)的机械感测模块108的运动水平测量结果并且将针对当前起搏发起的心跳的LCP 100的识别出的运动水平与针对一个或多个先前的起搏发起的心跳的LCP 100的运动水平进行比较514。至少部分地基于比较,处理模块110或其他处理模块可识别516其中植入LCP 100的患者的运动水平。至少部分地基于识别出的患者的运动水平,处理模块110或其他处理模块可设定518用于LCP 100的起搏频率参数。
在一些情况下,并且如上文关于频率自适应起搏所讨论的,将针对当前心跳的LCP100的识别出的运动水平与针对先前心跳的LCP 100的运动水平进行比较可以包括确定所比较的运动水平之间的差。然后,基于该差,LCP 100的处理模块110可设定或更新患者的运动水平(例如,活动水平),并从而设定或更新LCP 100的起搏频率参数。在一个示例中,患者的运动水平的值可以是对应于当前心跳的运动水平与对应于先前心跳的运动水平之间的差的绝对值,但是可以预期其他关系。用于比较与不同心跳相关联的LCP 100的运动水平并确定患者的运动水平的该一般过程以及其他过程可在本文讨论的各种技术中使用。
可替代地或另外地对于将针对当前心跳的LCP 100(例如,IMD)的运动水平与针对紧接的先前心跳的LCP 100的运动水平进行比较508、514,处理模块110可将针对当前心跳的LCP 100的运动水平与针对以与当前心跳相同节律(例如,内在节律或起搏节律)发起的N个先前的心跳(例如,两个或更多个先前的心跳)的LCP 100的运动水平的平均值进行比较。针对N个先前心跳的LCP 100的运动水平的平均值可以是直线平均值、加权平均值(例如,其中与一个或多个先前心跳相关联的运动水平被加权的大于与心跳相关联的另一运动水平),和/或运动水平的一个或多个其他平均值。在其他情况下,可将LCP 100的运动水平与以下一个或多个其他统计分析进行比较,其与关联于先前心跳的LCP 100的运动水平相关。然后,该比较可用于确定患者的运动水平和/或用于设定LCP 100的起搏频率。
N个先前心跳的数量可通过滑动或移动时间窗口来确定,该时间窗口从当前心跳延伸回预定的时间量或预定数量的跳动。在一个示例中,在当前心跳之前可以存在预定的时间量t,并且在时间t期间可以存在七(7)个心跳。在这七个心跳中,四个可以是内在发起的心跳,并且三个可以是起搏发起的心跳。因此,如果当前心跳是内在发起的心跳,则可将关联于当前心跳的运动水平与关联于时间t内的四个内在发起的心跳的四个运动水平的平均值进行比较。如果当前心跳是起搏发起的心跳,则可将关联于当前心跳的运动水平与关联于时间t内的三个起搏发起的心跳的三个运动水平的平均值进行比较。预定时间t可以是小于一(1)秒的任何时间,一(1)秒和三(3)分钟之间的时间,一(1)秒和(2)分钟之间的时间,一(1)秒和一(1)分钟,或大于三(3)分钟的任何时间。
如果在滑动或移动窗口内没有发生被由与当前心跳相同的节律类型(例如,内在或起搏)发起的心跳,则可不将关联于当前心跳的LCP 100的运动水平与关联于心跳的运动水平进行比较或可采取一个或多个其他动作。在这种情况下,可不更新患者的运动水平,并且可不响应于当前心跳而更新或重新设定用于LCP 100的起搏频率。
虽然针对以与当前心跳相同的方式发起的先前心跳相关联的运动水平求平均来讨论滑动或移动窗口,但是滑动或移动窗口可在其他情况下和/或在不平均窗口内的运动水平的情况下使用。例如,处理模块110可将LCP 100的运动水平与以下LCP 100的运动水平进行比较,该LCP 100的运动水平与滑动或移动窗口内的一个先前且类似地发起的心跳相关联。也就是说,可丢弃与在滑动或移动窗口之外的先前类似地发起的心跳相关联的所有运动水平,并且可以将与当前心跳相关联的运动水平与与窗口内最近类似地发起的心跳相关联的运动水平进行比较。另外地或可替代地,如果在滑动或移动窗口内没有先前类似地发起的心跳,则可使用第二或另外的滑动或移动窗口(例如,具有比第一滑动或移动窗口更长的持续时间)。在这种情况下,可将与在第二或另外的滑动或移动窗口中的先前类似地发起的心跳相关联的运动水平的平均值与当前心脏的运动水平进行比较,但这不是必需的。
在一些情况下,LCP 100可至少部分地基于与最近心跳相关联的患者的运动水平来跳过设定起搏频率,并且作为替代地,保持最近心跳的先前建立的起搏频率。例如,如果最近的心跳被识别为内在发起的心跳或起搏发起的心跳并且直接在由相同类型的节律发起的心跳之后(例如,紧接其之后或顺序跟随其),则LCP 100可以至少部分地基于与最近心跳相关联的患者的运动水平来设定起搏频率,如关于说明性方法500所讨论的。然而,在该示例中,如果最近的心跳是由与紧接的先前心跳不同类型的节律发起的,则LCP 100可保持先前建立的起搏频率,并且基本上忽略最近的心跳。
图7描绘了用于基于当前心跳确定是否更新患者的运动水平(例如,活动水平)并因此更新设定的起搏频率的说明性方法600。说明性方法600可由LCP的处理模块110执行,并且可单独使用或与本文描述的其他技术和过程组合使用。
如图7所示,说明性方法600可包括确定602当前识别的心跳是否由与紧接的先前心跳的内在节律或起搏节律中的相同一个发起。如果当前识别的心跳不是由与紧接的先前心跳的内在节律或起搏节律中的相同一个发起,则LCP 100可跳过更新604针对当前心跳的患者的运动水平。在一些情况下,不更新604患者的运动水平可包括不识别针对当前心跳的LCP 100的运动水平或者忽略针对当前心跳的识别出的LCP 100的运动水平。结果,可维持606患者的先前设定的起搏频率。在一些情况下,处理模块110可以采取一个或多个步骤来基于除了患者的运动水平之外的一个或多个参数改变起搏频率,而不是维持606患者的先前设定的起搏频率。
在说明性方法600中,如果当前识别的心跳由与紧接的先前心跳的内在节律或起搏节律中的相同一个发起,则LCP 100可更新608患者的运动水平。在一个示例中,可通过处理模块110或其他处理模块通过从机械感测模块108识别LCP 100的运动水平(例如,来自加速度计信号)来更新患者的运动水平,将识别出的LCP 100的运动水平与针对紧接的先前心跳的LCP 100的运动水平进行比较并且至少部分地基于该比较来确定患者的运动水平,但这不是需要的,并且可利用其他技术。一旦更新了患者的运动水平,LCP 100可至少部分地基于患者的更新的运动水平更新(例如,设定)610起搏频率。
在一些情况下,可能发生融合发起的心跳。融合发起的心跳是其中心脏的起搏节律和内在节律在相同或接近相同的时间发生并引起融合心跳的心跳。如果当前识别的心跳是融合发起的心跳,则LCP 100可以跳过更新针对当前心跳的患者的运动水平。在一些情况下,不更新或识别患者的运动水平可包括不识别针对当前心跳的LCP 100的运动水平或者忽略针对当前心跳的识别出的LCP 100的运动水平。结果,可保持针对患者的先前设定的起搏频率。在一些情况下,代替保持针对患者的先前设定的起搏频率,处理模块110可采取一个或多个步骤以基于除患者的运动水平之外的一个或多个参数来改变起搏频率。
图8描绘了可由LCP 100的处理模块110实现的说明性方法700,并且其可单独使用或与本文描述的其他技术和过程组合使用。在说明性方法700中,可识别702患者的当前心率并且至少部分地基于识别出的心率来将当前心率识别704为对应于两个或更多个的心率范围的特定心率范围。可以以任何方式确定心率范围。在一个示例中,第一心率范围可指示患者的静息活动水平,第二心率范围可指示患者的活跃活动水平(例如,步行),并且第三心率范围可指示患者的剧烈活动水平(例如跑步)。另外,在一些情况下,识别为对应于每个心率范围的心跳可进一步分类为内在发起的或起搏发起的。针对内在发起的或起搏发起的当前心跳,可识别706LCP 100的运动水平,并且可将运动水平与对应心率范围中的一个或多个类似发起的心跳的LCP 100的运动水平进行比较708。然后,可至少部分地基于比较来识别710患者的运动水平。
在一些情况下,并非——在当前心跳不由相同的内在或起搏节律发起时忽略当前心跳的运动水平,而是——预期的是可以施加偏移。可施加偏移来校正对于当前心跳所采取的运动水平测量结果中的“噪声”,其起因于当前心跳不是由与紧接的先前心跳相同的内在节律或起搏节律发起的(例如,参见图5的运动信号454和运动信号456之间的线A-A处的偏移)。图9中示出了说明性方法800,其用于使用偏移来确定患者的运动水平(尤其针对从内在节律转变为起搏节律的心跳以及反之亦然)。
说明性方法800包括识别802多个心跳并且将两个或更多个识别出的心跳中的每个识别804为内在发起的心跳或起搏发起的心跳。然后,LCP 100的处理模块110可确定806当前心跳是否由紧接的先前心跳的内在节律或起搏节律中的相同一个发起。在说明性方法800中,如果当前心跳由紧接的先前心跳的内在节律或起搏节律中的相同一个发起,则处理模块110可使用机械感测模块108的运动传感器(例如,加速度计)识别808LCP 100(例如,IMD)的运动水平并将识别出的LCP 100的运动水平与对应于一个或多个先前且类似发起的(例如,内在发起的或起搏发起的)心跳的LCP 100的运动水平进行比较810。在一些情况下,并且类似于上面讨论的,可在心动周期的收缩阶段期间获取对应于来自机械感测模块108的运动传感器的测量结果的运动水平,但这不是必需的。至少部分地基于比较810,处理模块110可识别812患者的运动水平,并且至少部分地基于识别出的患者的运动水平来设定822LCP 100的起搏频率参数。
在说明性方法800中,如果当前心跳由紧接的先前心跳的内在节律或起搏节律中的不同的一个发起,则处理模块110可使用机械感测模块108的运动传感器(例如,加速度计)识别814LCP 100(例如,IMD)的运动水平并将偏移施加816到识别出的运动水平。在一个示例中,偏移可表示图5的运动信号454和运动信号456之间的线A-A处的偏移。然后,可以将具有所施加的偏移的针对当前心跳的识别出的LCP 100的运动水平与对应于紧接的先前心跳的LCP 100的水平运动进行比较818。在一些情况下,并且类似于上面讨论的那些,可以在心动周期的收缩阶段期间获取对应于来自机械感测模块108的运动传感器的测量结果的运动水平,但这不是必需的。至少部分地基于比较818,处理模块110可识别820患者的运动水平并且至少部分地基于识别出的患者的运动水平来设定LCP 100的起搏频率参数。
用于确定偏移的一种说明性方法在图10中示出。图10的说明性方法900可用于确定要在从由不同的节律(例如,内在节律或起搏节律)发起的心跳的转变时被施加于当前心跳的运动水平的偏移。为了确定偏移,LCP 100的处理模块110或其他处理模块可识别902校准窗口。在一些情况下,校准窗口可覆盖其中N个起搏发起的心跳发生以及其中N个内在发起的心跳发生的时间段或窗口。说明性方法900可包括使用机械感测模块108的运动传感器识别904针对N个起搏发起的心跳的LCP 100(例如,IMD)的运动水平,并且使用机械感测模块108的运动传感器识别906针对N个内在发起的心跳的LCP 100的运动水平。N可以是一、二或更多数量的心跳。特定节律类型(例如,内在或起搏)的N个心跳可以是连续心跳,或者可由其他节律类型发起的一个或多个心跳分开。在一些情况下,为了获得N个连续起搏发起的心跳,可能有必要将起搏频率提高到高于当前内在心率的特定水平(例如,高于当前内在心率的每分钟5-30跳,高于当前内在心率的每分钟10-20跳,和/或高于当前内在心率的不同水平)。在一些情况下,为了获得N个连续的内在发起的心跳,可能有必要将起搏频率降低到低于当前内在心率的特定水平(例如,低于当前内在心率的每分钟5-10跳,和/或低于当前内在心率的不同水平)。在一些情况下,机械感测模块108的运动传感器对于N个心跳中的每个获取的测量结果可在心动周期的收缩阶段期间获取,但这不是必需的。
根据针对N个起搏发起的心跳的识别出的运动水平,处理模块110可识别基线起搏运动水平。类似地,根据针对N个内在发起的心跳的识别出的运动水平,处理模块110可识别基线内在运动水平。至少部分地基于基线起搏运动水平和基线内在运动水平,处理模块110可确定偏移,其可施加于与由以下节律发起的心跳相关联的运动水平,该节律不同于发起了紧接的先前心跳的节律。
可以以任何方式识别基线起搏运动水平和/或基线内在运动水平。在一个示例中,可对与N个起搏发起的心跳相关联的LCP 100的运动水平进行平均以获得基线起搏运动水平。类似地,在示例中,可对与N个内在发起的心跳相关联的LCP 100的运动水平进行平均以获得基线内在运动水平。另外地或作为可替代地,对于与心跳相关联的运动水平的求平均,可对识别出的运动水平执行其他分析。例如,针对较旧的心跳检测到的运动水平可被加权小于最近检测到心跳的运动水平。
图11A-11C示出了曲线图960a、960b、960c,其分别表示对于N个起搏发起的心跳和N个内在发起的心跳中的每个的由LCP 100的运动传感器(诸如三轴加速度计)产生的来自不同轴x轴、y轴和z轴的运动水平信号的平均值,其中LCP 100附接到患者心脏的壁。在曲线图960a-960c中以虚线示出的信号962表示在相应轴上的N个起搏发起的心跳的加速度计幅度信号的平均值(例如,基线运动水平信号)。以实线表示的信号964表示N个内在发起的心跳的加速度计幅度信号的平均值(例如,基线运动水平信号)。
在图11A-11C所示的示例中,可通过在每个曲线图中的预定时间处确定信号962和964之间的差并且使用在预定时间处的最大差作为偏移来选择偏移。可替代地,可以将预定时间处的最小差用作偏移。可替代地,可以对每个轴的差进行平均以确定偏移。在又另一个示例中,可执行一个或多个其他分析以确定偏移。如图11A-11C的示例所示,在已经识别出心跳之后,在线A-A处预定时间可以是200ms。在该示例中,在200ms处,信号962和964在x轴上具有175个单位(图11A)的差,在y轴上具有125个单位(图11B)的差,并且在z轴上具有125个单位(图11C)的差。利用该示例,处理模块110或其他模块可选择x轴的差作为偏移,因为它是从当发起心跳时起200ms处的信号962和964之间的最大差。
上面讨论的校准窗口可根据预定时间段来识别,并且可响应于来自LCP 100外部的设备或其他信号的信号而开始。可替代地或另外地,在N个连续起搏发起的心跳之后和/或在N个连续内在发起的心跳之后,LCP 100或其他设备可识别校准窗口,其中N可以是相同数量或不同数量的起搏发起的心跳和内在发起的心跳。
在一些情况下,可基于患者活动水平选择校准窗口。在一个示例中,可选择校准窗口以在其中植入LCP 100的患者不执行活动或处于低活动水平时发生。说明性地,不活动或低活动水平可包括患者正坐下、躺下、处于站立位置、处于特定姿势和/或处于一个或多个静态或基本静态位置。
在一些情况下,可自动发起校准窗口以开始偏移确定过程(诸如方法900)。例如,LCP 100可检测患者何时处于特定位置或姿势并且可自动发起校准窗口。在一些情况下,LCP 100可检测到在预定的时间长度内患者的运动水平或活动水平已经跨过(例如,低于或超过)运动或活动的阈值水平,并且然后发起校准窗口。此外,并且在一些情况下,如果LCP100除了检测到患者处于特定位置或姿势之外还检测到与外部设备的通信,则LCP 100可仅自动地发起校准窗口,但这不是必需的。可替代地或另外地,如果LCP 100检测到一天中的特定时间,则LCP 100可仅自动发起校准窗口。校准窗口的这种自动发起可允许LCP 100随时间更新偏移以考虑改变条件。
在一些情况下,LCP 100可被配置为检测其中已经植入LCP 100的患者的一个或多个位置或姿势(例如,N个位置或姿势)。这可允许LCP 100:1)为患者的不同位置或姿势创建偏移库;以及2)当患者处于对应位置或姿势时,对不同的位置或姿势施加偏移。对于患者的每个姿势或位置,处理模块110或其他处理模块可识别校准窗口。在每个校准窗口期间,处理模块110或其他处理模块针对N个内在发起的心跳可使用机械感测模块108的运动传感器来识别LCP 100(例如,IMD)的运动水平,并且针对N个起搏发起的心跳使用运动传感器来识别LCP 100运动水平,其中相应的N个心跳可以是两个或更多个心跳,并且可以是或可以不是连续的心跳。此外,可以在心动周期的收缩阶段期间获取来自运动传感器的测量结果,但这不是必需的。
基于针对起搏发起的心跳的LCP 100的识别出的运动水平,处理模块110或其他处理模块可识别针对识别出的患者姿势或位置的基线起搏运动水平。类似地,基于针对内在发起的心跳的LCP 100的识别出的运动水平,处理模块110或其他处理模块可识别针对识别出的患者姿势或位置的基线内在运动水平。然后,以类似于以上关于方法900所讨论的方式,处理模块可至少部分地基于针对识别出的姿势或位置的基线内在运动水平和基线起搏运动水平来确定识别出的患者姿势或位置的偏移。
然后,可以将对应于各种患者姿势或位置的偏移保存在LCP 100的存储器(例如,处理模块110的存储器或其他存储器)中和/或LCP 100外部的存储器中的库中。然后,当识别到由与紧接的先前节律不同的节律(例如,内在节律或起搏节律)发起的心跳时,在将运动水平与针对紧接的先前心跳的LCP 100的运动水平进行比较之前或之后,LCP 100可识别患者的姿势或位置并将姿势或位置特定偏移施加于针对当前心跳的LCP 100运动水平。
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 (12)
1.一种能被植入在患者心脏的可植入医疗设备(IMD),所述IMD包括:
两个或更多个传感器,包括运动传感器;
控制器,其能***作地耦合到所述两个或更多个传感器,所述控制器被配置为:
使用传感器中的一个或多个来识别多个心跳,所述多个心跳中的每一个具有收缩阶段和舒张阶段;
将所述多个心跳中的两个或更多个心跳中的每一个识别为内在发起的心跳或起搏发起的心跳;
针对内在发起的心跳,使用所述运动传感器来识别所述IMD的运动水平,并且将识别出的所述IMD的运动水平与针对一个或多个先前内在发起的心跳而识别出的所述IMD的运动水平进行比较,并且至少部分地基于所述比较来识别所述患者的运动水平,并且至少部分地基于识别出的所述患者的运动水平来设定起搏频率参数;
针对起搏发起的心跳,使用所述运动传感器来识别所述IMD的运动水平,并且将识别出的所述IMD的运动水平与针对一个或多个先前起搏发起的心跳而识别出的所述IMD的运动水平进行比较,并且至少部分地基于所述比较来识别所述患者的运动水平,并且至少部分地基于识别出的所述患者的运动水平来设定起搏频率参数。
2.根据权利要求1所述的IMD,其中,针对紧接起搏发起的心跳之后的内在发起的心跳,所述控制器被配置为不基于该心跳来识别所述患者的运动水平。
3.根据权利要求1和权利要求2中任一项所述的IMD,其中,针对紧接内在发起的心跳之后的起搏发起的心跳,所述控制器被配置为不基于该心跳来更新所述患者的运动水平。
4.根据权利要求1或2所述的IMD,其中,针对内在发起的心跳,所述控制器被配置为:
如果紧接在前的心跳是内在发起的心跳,则将识别出的所述IMD的运动水平与针对所述紧接在前的心跳而先前识别出的所述IMD的运动水平进行比较;并且
如果紧接在前的心跳是起搏发起的心跳,则要么在所述内在发起的心跳的收缩阶段期间不使用所述运动传感器来识别所述IMD的运动水平,要么忽略识别出的所述IMD的运动水平。
5.根据权利要求1或2所述的IMD,其中,针对起搏发起的心跳,所述控制器被配置为:
如果紧接在前的心跳是起搏发起的心跳,则将识别出的所述IMD的运动水平与针对所述紧接在前的心跳而先前识别出的所述IMD的运动水平进行比较;并且
如果紧接在前的心跳是内在发起的心跳,则要么在所述起搏发起的心跳的收缩阶段期间不使用所述运动传感器来识别所述IMD的运动水平,要么忽略识别出的所述IMD的运动水平。
6.根据权利要求1或2所述的IMD,其中,所述控制器被配置为:
针对内在发起的心跳,将识别出的所述IMD的运动水平与以下IMD的平均运动水平进行比较,所述IMD的平均运动水平为针对两个或更多个先前内在发起的心跳而识别出的所述IMD的运动水平的平均值;并且
针对起搏发起的心跳,将识别出的所述IMD的运动水平与以下IMD的平均运动水平进行比较,所述IMD的平均运动水平为针对两个或更多个先前起搏发起的心跳而识别出的所述IMD的运动水平的平均值。
7.根据权利要求6所述的IMD,其中:
针对内在发起的心跳,所述IMD的平均运动水平是加权平均值;并且
针对起搏发起的心跳,所述IMD的平均运动水平是加权平均值。
8.根据权利要求6所述的IMD,其中,所述两个或更多个先前内在发起的心跳和所述两个或更多个先前起搏发起的心跳全部都落入向后延伸预定时间量的移动时间窗口内。
9.根据权利要求1或2所述的IMD,其中,所述控制器被配置为:
识别所述患者的心脏的当前心率;
至少部分地基于识别出的当前心率而将当前心跳识别为对应于两个或更多个心率范围中的一个;
针对内在发起的心跳,将识别出的所述IMD的运动水平与针对已经被识别为对应于相同心率范围的一个或多个先前内在发起的心跳而识别出的所述IMD的运动水平进行比较,并且至少部分地基于所述比较来识别所述患者的运动水平;并且
针对起搏发起的心跳,将识别出的所述IMD的运动水平与针对已经被识别为对应于所述相同心率范围的一个或多个先前起搏发起的心跳而识别出的所述IMD的运动水平进行比较,并且至少部分地基于所述比较来识别所述患者的运动水平。
10.根据权利要求1或2所述的IMD,其中,所述控制器被配置为:
将所述多个心跳中的每一个识别为内在发起的心跳、起搏发起的心跳或融合心跳;并且
其中,针对融合心跳,不基于该心跳来识别所述患者的运动水平。
11.根据权利要求1或2所述的IMD,其中,所述运动传感器包括三轴加速度计,并且两个或更多个传感器中的另一个包括两个或更多个电极,其连接到被配置为感测所述患者的心脏的电信号的电路。
12.根据权利要求1或2所述的IMD,其中,所述IMD是无引线心脏起搏器。
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CN109952128A (zh) | 2019-06-28 |
EP3532158B1 (en) | 2022-12-14 |
JP6843235B2 (ja) | 2021-03-17 |
EP3532158A1 (en) | 2019-09-04 |
US10434317B2 (en) | 2019-10-08 |
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