CN108136186B - 用于医疗装置之间的通信的***和方法 - Google Patents
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Abstract
描述了用于传导通信的***和方法。在一个实施例中,与在患者内植入的医疗装置通信的方法包括:在医疗装置处经由连接到患者的电极接收传导通信信号,其中传导通信信号包括信号分量和噪声分量。该方法可以进一步包括:由医疗装置至少部分地基于接收到的传导通信信号的幅度来调整接收阈值,以便减小传导通信信号的噪声分量的幅度。
Description
相关申请的交叉引用
本申请要求于2015年8月20日提交的美国临时专利申请序列号62/207,686的权益,其全部内容通过引用并入本文。
技术领域
本公开总体上涉及用于在医疗装置之间进行通信的***、装置和方法,并且更具体地涉及使用传导通信(conducted communication)在医疗装置之间进行通信的***、装置和方法。
背景技术
主动可植入医疗装置常规地植入患者身体。这种可植入医疗装置通常用于提供治疗、诊断或两者皆有。在一些情况下,可能希望经由皮肤诸如经由位于身体外部的编程器(programmer)等与可植入医疗装置通信。这种通信可以通过传导通信,其将电流通过患者的身体组织从一个装置传导到另一个。在编程器的例子中,编程器可以通过电极皮肤贴片等与患者的身体电连接。这种通信可以便于编程器编程和/或重新编程可植入医疗装置,读取由可植入医疗装置收集的数据,和/或收集或交换任何其他合适的信息。在一些情况下,两个或更多个可植入医疗装置可以与患者一起植入。在这种情况下,可能需要使用传导通信在两个或更多个植入的医疗装置之间建立通信。这样的通信可以使植入的医疗装置共享数据,分配控制和/或治疗的递送,和/或执行其他期望的功能。这些仅仅是身体中的传导通信的一些例子。
发明内容
本公开一般涉及用于在医疗装置之间进行通信的***、装置和方法,并且更具体地涉及使用传导通信在医疗装置之间进行通信的***、装置和方法。
在一个实施例中,与在患者内植入的医疗装置进行通信的方法可以包括在医疗装置处经由连接到患者的电极接收传导通信信号,其中传导通信信号包括信号分量和噪声分量。在一些另外的实施例中,该方法可以进一步包括由医疗装置至少部分地基于所接收的传导通信信号的幅度来调整接收阈值,并且其中调整接收阈值至少部分地减小传导通信信号的噪声分量的幅度。
另外地或可选地,在上述实施例中的任何一个中,至少部分地基于所接收的传导通信信号的幅度来调整接收阈值可以包括:在通信窗口期间由医疗装置对传导通信信号中的具有大于接收阈值的幅度的脉冲数量进行计数,由医疗装置确定所计数的脉冲数量是否超过脉冲计数阈值,并且在确定所计数的脉冲数量超过脉冲计数阈值之后,由医疗装置增加接收阈值。
另外地或可选地,上述实施例中的任何一个可以进一步包括将接收阈值增加预定量。
另外地或可选地,在上述实施例中的任何一个中,脉冲计数阈值可以表示可以形成消息的脉冲的最大数量。
另外地或可选地,上述实施例中的任何一个可以进一步包括在确定所计数的脉冲数量超过脉冲计数阈值之后,由医疗装置开始新的通信窗口。
另外地或可选地,上述实施例中的任何一个可以进一步包括由医疗装置跟踪通信会话定时器,并且在确定通信会话定时器已经达到阈值之后,由医疗装置将接收阈值设置为较低的预定值。
另外地或可选地,上述实施例中的任何一个可以进一步包括在成功接收消息之后由医疗装置重置通信会话定时器。
另外地或可选地,在上述实施例中的任何一个中,至少部分地基于所接收的传导通信信号的幅度来调整接收阈值可以包括:在通信窗口定时器达到阈值之后,由医疗装置确定在通信窗口定时器达到阈值之前是否接收到消息,其中所述消息表示通信信号中的具有高于接收阈值的幅度的脉冲的预定序列,并且在确定在通信窗口定时器达到阈值之前没有接收到消息之后,由医疗装置增加接收阈值。
另外地或可选地,在上述实施例中的任何一个中,增加接收阈值可以包括将接收阈值增加预定量。
另外地或可选地,上述实施例中的任何一个可以进一步包括:在通信窗口定时器已经达到阈值之前,由医疗装置确定是否已经接收到消息,并且在确定在通信窗口定时器已经达到阈值之前已经接收到消息之后,由医疗装置重置通信窗口定时器值。
另外地或可选地,上述实施例中的任何一个可以进一步包括由医疗装置跟踪通信会话定时器,并且在确定通信会话定时器已经达到阈值之后,由医疗装置将接收阈值设置为较低的预定值。
另外地或可选地,上述实施例中的任何一个可以进一步包括在确定已经接收到消息之后由医疗装置重置通信会话定时器。
另外地或可选地,在上述实施例中的任何一个中,至少部分基于所接收的传导通信信号的幅度来调整接收阈值可以包括:由医疗装置将接收阈值设置为与具有高于接收阈值的幅度的通信信号的脉冲的最大幅度成比例的值。
另外地或可选地,在上述实施例中的任何一个中,将接收阈值设置为与具有高于接收阈值的幅度的通信信号的脉冲的最大幅度成比例的值包括:将接收阈值设置为具有高于接收阈值的幅度的通信信号的脉冲的幅度的最大值。
另外地或可选地,上述实施例中的任何一个可以进一步包括由所述医疗装置将接收阈值设置为与具有高于接收阈值的幅度的通信信号的每个脉冲的最大幅度成比例的值。
另外或可选地,在上述实施例中的任何一个中,接收阈值可根据预定函数衰减。
在其他实施例中,一种医疗装置可以包括一个或多个电极以及连接到一个或多个电极的控制器。在这些实施例中的一些中,控制器可以被配置为接收包括经由一个或多个电极从外部医疗装置传送的传导通信信号和噪声信号的信号,并且至少部分地基于传导通信信号和噪声信号的幅度调整接收阀值以滤除来自接收信号的噪声信号。
另外地或可选地,在上述实施例中的任何一个中,控制器还可以被配置为通过将接收阈值设置为与超过接收阈值的接收到的信号的每个脉冲的最大幅度成比例的值来调整接收阈值。
另外地或可选地,在上述实施例中的任何一个中,接收阈值可以被配置为根据预定的衰减函数衰减。
在又一个实施例中,一种医疗装置可以包括一个或多个电极以及连接到一个或多个电极的控制器。在这些实施例中的一些中,控制器可以被配置为在通信窗口期间经由一个或多个电极接收传导通信信号,并且对通信窗口内并且具有大于接收阈值的幅度的传导通信信号的脉冲的数量进行计数。另外地,控制器还可以被配置为如果脉冲计数达到脉冲计数阈值,则增加接收阈值并且开始新的通信窗口。
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示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是包括被配置用于通过身体的传导通信的装置的医疗装置***的示意图;
图5描绘了由包括噪声分量和信号分量的医疗装置感测的示例传导通信信号;
图6示出了根据本公开的技术的通过具有第一接收阈值的比较器电路中继之后的示例传导通信信号;
图7是可以由医疗装置或医疗装置***诸如关于图1至图4描述的说明性医疗装置和医疗装置***实现的说明性方法的流程图;
图8示出了根据本公开的技术的通过具有第二接收阈值的比较器电路中继之后的另一示例传导通信信号;
图9是可以由医疗装置或医疗装置***诸如关于图1至图4描述的说明性医疗装置和医疗装置***实现的说明性方法的流程图;
图10描绘了根据本公开的技术的另一示例传导通信信号以及衰减接收阈值;
图11A描绘了示例贴片完整性信号;
图11B描绘了根据本文公开的技术的可以由医疗装置诸如关于图1至图4描述的说明性医疗装置和医疗装置***生成的示例抵消信号或反相信号;
图12描绘了根据本文公开的技术的在第二医疗装置正在递送抵消信号或反相信号的同时可以由第一医疗装置感测的示例贴片完整性信号;
图13是可以被包括在外部支持装置上的示例用户界面的示意图;并且
图14是根据本文公开的技术的用于交替地将第一医疗装置和第二医疗装置连接到被连接至患者的一对电极以增强通过患者的传导通信的医疗装置***的示意图。
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。
本公开描述了用于在医疗装置之间进行通信的***、装置和方法。本公开的一些医疗装置***可以使用传导通信技术进行通信,该传导通信技术可以包括将电通信信号递送到患者身体中以通过患者身体进行传导。该信号可以被另一个医疗装置接收,从而建立装置之间的通信链路。
图1是示例性无引线心脏起搏器(LCP)的概念示意性框图,其可以被植入在患者的心脏上或心室内,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。示例性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)等。如在图1中可以看出的,LCP 100可以是具有被容纳在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。尽管使用无引线心脏起搏器(LCP)作为示例性可植入医疗装置,但预期的是可以使用任何合适的可植入医疗装置,包括提供治疗(例如起搏,神经刺激等)、诊断(感测)或两者的可植入医疗装置。
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,并电性暴露于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。举例而言,这样的电信号可以包括通信信号、电刺激脉冲和固有心脏电信号。固有心脏电信号可以包括通过心脏生成的电信号,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,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。在这样情况中,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。在这样的情况中,电极114可以被放置在从外壳120远离其延伸的尾部(未示出)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’可以是除了电极114以外的,或者可以替代电极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的侧面上之外。在这些情况中,电极114’可以增加LCP 100可以通过其递送通信信号和/或电刺激脉冲,和/或感测固有心脏电信号、通信信号和/或电刺激脉冲的电极数量。
电极114和/或114’可以采取各种尺寸和/或形状中的任何一种,并且可以以多种间隔中的任何一种隔开。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隔。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和/或长度可能均匀或可能不均匀。
在示出的实施例中,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,通信信号可以被限制为不导致心脏捕获但仍然传达信息的亚阈值信号。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装置。在一些情况下,通信可以采取分离不同时间量的有区别通信脉冲的形式。在其中一些情况下,连续脉冲之间的计时可以传达信息。通信模块102可以另外被配置为感测由可位于患者身体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,使用传送的数据以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。在某些情况下,LCP 100可以使用通信信号来传送原始信息、经处理的信息、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)和从被耦接的传感器收集的信号等的信息。在一些实施例中,经处理的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。经处理的信息还可以包括由LCP100和/或其他装置确定出的参数和/或事件,例如,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、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经由哪个电极114和/或114’递送通信脉冲。预期的是,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/或任何其他合适的通信方法学与其他装置进行通信。在通信模块102产生电通信信号的地方,通信模块102可以包括一个或多个电容器元件和/或其他电荷存储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可以使用被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可以包括切换电路,该切换电路连接到能量存储模块112,并且与切换电路一起可以将能量存储模块112连接到电极114/114'中的一个或多个以生成通信信号。
如图1所示,脉冲发生器模块104也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疾病或异常的目的的任何电信号。例如,当用于治疗心脏疾病时,脉冲发生器模块104可以生成用于捕获患者心脏的电刺激起搏脉冲,即,响应于递送的电刺激脉冲使心脏收缩。在这些情况中的一些情况下,LCP 100可以改变脉冲发生器104产生电刺激脉冲的速率,例如在速率自适应起搏中。在其他实施例中,电刺激脉冲可以包括除颤/心律转复脉冲,以用于使心脏从纤维性颤动震动出或震动到正常心脏节律中。在其他实施例中,电刺激脉冲可以包括抗心动过速起搏(ATP)脉冲。应该明白,这些只是一些例子。当用于治疗其他疾病时,脉冲发生器模块104可以生成适用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/或其他电荷存储装置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。在一些特定实施例中,脉冲发生器模块104可以包括切换电路,该切换电路连接到能量存储模块112,并且可以将能量存储模块112连接到电极114/114'中的一个或多个以生成电刺激脉冲。
LCP 100还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的固有心脏电信号。例如,电感测模块106可以被电连接到电极114和/或114’中的一个或多个,并且电感测模块106可以被配置为经由传感器放大器等接收通过电极114和/或114’传导的心脏电信号。在一些实施例中,心脏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,如果将LCP 100植入心脏的心室内,则由LCP 100通过电极114和/或114’感测到的心脏电信号可以表示心室心脏电信号。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脏电信号和/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/或能量存储模块可以被认为是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接收心脏电信号和/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例如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。在又一些额外实施例中,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视作比从电感测模块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。
在确定出心律失常的存在之后,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落到预定阈值之下。在一些情况下,起搏速率可随着患者活动水平的增加而增加(例如速率自适应起搏)。例如,处理模块110可监视可指示对增加心率的需要的患者的一个或多个生理参数(例如由于增加的代谢需求所致)。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脏电信号而跳动。一旦心脏正遵循起搏脉冲,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,以提供不同于上面描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***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信息。通信模块102还可以由处理模块110接收通信信号以用于潜在动作。
在进一步的实施例中,处理模块110可以控制切换电路,通信模块102和脉冲发生器模块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。在这样的实施例中,处理模块110可以视情况而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可以在能够维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。在其他情况下,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,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)可以是易失性存储器、非易失性存储器或者易失性存储器和非易失性存储器的组合。
能量存储模块112可以向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。在其他实施例中,能量存储模块112可以是可再充电电池。在另外实施例中,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。为了促进固定,LCP 100可以包括一个或多个锚定件(anchor)116。该一个或多个锚定件116被示意性地示出在图1中。该一个或多个锚定件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件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,以帮助将锚定件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,该锚定构件具有可以旋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可以被配置为植入在患者心脏上或患者心脏的腔室内。例如,LCP100可以植入患者心脏的左心房,右心房,左心室或右心室中的任一个内。通过植入特定的腔室内,LCP100可以能够感测发自或出自特定腔室的心脏电信号,而其他装置可能不能以这种分辨率来感测。在LCP100被配置成植入在患者心脏上的情况下,LCP100可以被配置为植入心脏的一个腔室上或其附近,或者在本征地生成的心脏电信号通常遵循的路径上或其附近。在这些例子中,LCP100还可以具有增强的感测局部本征心脏电信号以及递送局部电刺激治疗的能力。
图2描绘了可以操作以感测生理信号和参数并且/或者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,MD200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。在这样的实施例中,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和位于外壳内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可以将固有生成的电心脏信号传导到引线212。引线212继而可以将接收到的电心脏信号传导至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/或传感器。在这样的实施例中,机械感测模块208可以与引线212电通信,并且可以接收从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可以是可植入医疗装置。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脏电信号,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电心脏信号、基于感测到的电心脏信号来确定快速性心律失常的发生、并且响应于确定出快速性心律失常的发生而递送除颤和/或心律转复治疗(例如通过向患者的心脏递送除颤和/或心律转复脉冲)。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,然而这不是被要求的。
在一些实施例中,MD 200可以不是可植入医疗装置。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(例如由心脏生成的电心脏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)。MD 200还可以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。在至少一些示例中,外部装置306可以表示诸如装置编程器的外部支持装置,如下面将更详细地描述的。其他传感器/装置310可以是先前关于MD 200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可以感测固有的心脏电信号,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经由通信路径308而另外地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,本文中被称为电通信脉冲)发送到患者的身体内,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。患者的身体可以将传导通信信号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,通信脉冲可以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(如果需要的话)。在一些情况下,递送的电通信脉冲可能是起搏脉冲中的凹口或其他干扰。
与正常的电刺激治疗脉冲不同,电通信脉冲可以以传送信息到接收装置的特定序列(sequence)递送。例如,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示出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***400。例如,***可以包括被连接到由心脏410和皮肤415表示的患者的多个装置,其中至少一些装置被配置用于与其他装置进行通信。在示例性***400中,示出了LCP 402被固定到心脏410的右心室的内部,并且外部支持装置420和外部除颤器406被示出为分别通过皮肤电极404和408连接到皮肤415。可以使用外部支持装置420来执行功能诸如装置识别、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的实时和/或存储的数据的传送。在至少一些实施例中,LCP 402和外部支持装置420被配置为通过传导通信进行通信。
在一些实施例中,外部除颤器406可以被配置为通过皮肤415将电压和/或电流信号作为贴片完整性信号(patch-integrity signal)递送到患者,并且可以进一步感测贴片完整性信号以便确定关于电极408和皮肤415之间的接触的信息。外部除颤器406可以被配置为,如果接收到的贴片完整性信号指示出电极408与皮肤415之间的接触不足以实现心脏410的心脏电信号的贴片电极(patch electrode)408的充分感测和/或用于除颤和/或心律转复脉冲的安全输送,则显示或发出警报。在一些实施例中,贴片完整性信号可以表示连续信号,诸如正弦波,方波或锯齿波等。此外,在某些情况下,贴片完整性信号的频率可能在大约50kHz到大约150kHz之间,但这不是必需的。在一些情况下,该贴片完整性信号可能干扰由LCP 402和外部支持装置420递送和接收的传导通信信号。因此,LCP 402和/或外部支持装置420可采用一种或多种技术来增强其传导通信方案的有效性,如下面更详细描述。
应该理解的是,图4只是可以从本文公开的技术受益的一个示例***。其他***可以包括附加的和/或不同的装置,但是仍然可以包括将传导信号递送到患者体内的装置,其可能干扰被递送到患者体内的传导通信信号以进行装置间通信。另外,其他***可以具有不同的通信方案,其使用附加的通信模态和/或包括从第一装置接收传导通信信号并将接收到的消息中继到第二装置的中间装置。
图5描绘了可以由LCP 402接收的示例传导通信信号500。尽管以下示例的描述了使用外部支持装置420作为发射器并且使用LCP 402作为接收器,但应当理解,这仅仅是为了便于描述。下面描述的技术可以通过诸如***400之类的***的任何装置来实现,其中***的装置中的任意充当发射器以及***的装置中的任意充当接收器。这可以包括例如两个或更多植入的医疗装置例如LCP 402和另一个LCP(图4中未示出)和/或其他植入的装置之间的装置间通信。
在图5所示的示例中,传导通信信号500包括信号分量502和噪声分量504。在所示的示例中,信号分量502表示由外部支持装置420(或其他内部或外部装置)递送的一连串通信脉冲503。在所示的示例中,噪声分量504表示由外部除颤器406递送的贴片完整性信号。一旦LCP 402接收到传导通信信号,LCP 402就可以执行初始放大和/或滤波。图5的传导通信信号500可以表示初始放大和/或滤波的输出。LCP 402可以将传导通信信号500提供给比较器电路,该比较器电路可以是LCP 402的通信模块的一部分。比较器电路可以将传导通信信号500与接收阈值(诸如可编程接收阈值505)进行比较。在一些情况下,每次传导通信信号500高于可编程接收阈值505时,比较器电路可以产生脉冲,从而导致传导通信信号550,诸如在图6所示。即,在所示的示例中,每当传导通信信号500的幅度高于接收阈值505时,比较器电路可以生成高信号(例如,脉冲552中的一个)。
如所描述的,在一些传导通信方案中,所接收脉冲的特定特征或间隔(例如传导通信信号550的脉冲552)可以传达信息。在一些实施例中,LCP 402和外部支持装置420可以根据特定的通信协议来配置,由此脉冲特征和/或脉冲间隔的特定模式可以表示预定义的消息。一些示例消息可以包括标识消息,命令和对数据的请求等。如果接收到的一组脉冲不具有与识别出的消息格式对应的特征,则装置可以确定尚未接收到有效消息(validmessage),并且相反地,如果接收到的一组脉冲确实具有与识别出的消息格式对应的特征,装置可以确定已经接收到有效消息。
在至少一些情况下,LCP 402和/或外部支持装置420还可以通过针对错误校验接收到的消息来确定接收到的消息是否有效。例如,即使在接收到与识别出的消息格式相对应的一连串脉冲之后,接收装置也可以采用一个或多个错误校验方案,诸如重复码、奇偶校验位、校验和、或循环冗余校验(CRC)等等。当如此设置时,装置可以仅在如果错误校验算法确定接收到的消息中没有错误或没有重大错误,才确定接收到的消息是有效的。
如图6中可以看出,传导通信信号550包括从传导通信信号500的信号分量502和噪声分量504二者生成的脉冲552。因此,并且在一些情况下,LCP 402可以确定传导通信信号550不是有效消息,这是因为脉冲模式将不匹配识别出的消息格式。在该示例中,接收阈值505被设置得太低,使得噪声分量504的部分具有足够高的幅度以通过比较器电路并且在传导通信信号550中生成脉冲552。
图7是LCP 402(或另一装置)可以实施以便至少部分地基于传导通信信号500的幅度来调整接收阈值505的说明性方法700的流程图。将接收阈值505调整为高于传导通信信号500的噪声分量504的幅度可以仅允许信号分量502通过比较器电路,导致传导通信信号仅包括由于信号分量502引起的脉冲。这可以产生在LCP 402处接收到的有效消息。
在示例方法700中,LCP 402可以通过将接收阈值505设置为初始值来开始,如702所示。初始值可以被设置为使得在大多数情况下,接收阈值505低于传导通信信号500的信号分量502的幅度。接下来,LCP 402可以重置并开始通信窗口定时器,如704处所示,并且重置并开始通信会话定时器,如在706所示。在一些实施例中,LCP 402可以仅在预定义的时间处开始通信窗口定时器。例如,通信窗口定时器可以被同步以与感测到的心脏电信号(诸如R波)的一个或多个特征对齐。在这样的示例中,一旦LCP 402重置通信窗口定时器,LCP 402就可以等待启动通信窗口定时器,直到感测到心脏电信号中的特定特征为止。在至少一些情况下,LCP 402可以在感测到特定特征之后的预定时间后启动通信窗口定时器。作为一个例子,在感测到R波之后,LCP 402可以等待约50ms和约150ms之间以开始通信窗口定时器。
在一些情况下,如708处所示,LCP 402可以对接收到的传导通信信号中的接收到的脉冲的数量进行计数。例如,接收到的传导通信信号500可以通过使用接收阈值505的比较器电路,导致传导通信信号550。作为一个示例实现方式,LCP 402可以在每次LCP 402检测到传导通信信号550中的脉冲时增加一个脉冲计数值。
接下来,LCP 402可以确定通信会话定时器是否已经超过通信会话定时器阈值,如在710所示。如果通信会话定时器已经超过通信会话定时器阈值,则LCP 402可以再次返回702处开始方法700。通信会话定时器可以帮助确保:如果接收阈值505一度设置为高于传导通信信号500的信号分量502的最大幅度,则将接收阈值505重置为较低值。尽管步骤702包括将接收阈值505设置回其初始值,但是在一些情况下,如果LCP 402通过框712到达步骤702,则LCP 402可以将接收阈值505设置为与初始值不同的较低值。例如,LCP 402可以简单地减小接收阈值505的值而不是将其设置回其初始值。
如果LCP 402确定通信会话定时器未超过通信会话定时器阈值,则LCP 402可以确定通信窗口定时器是否已经超过通信窗口定时器阈值,如在712处所示。如果LCP 402确定通信窗口定时器超出通信窗口定时器阈值,则LCP 402可以重置脉冲计数并复位并开始通信窗口定时器,如在720处所示,然后在708处再次开始计数接收到的脉冲。
如果LCP 402确定通信窗口定时器未超过通信窗口定时器阈值,则LCP 402可以确定是否接收到有效消息,如在714处所示。例如,LCP 402可以将接收到的脉冲的模式与表示消息的预定义的脉冲模式进行比较。在一些情况下,LCP 402可以在确定接收到的脉冲的模式是否对应于预定义的脉冲模式之一之前或之后运行一个或多个错误校验方案。在确定出接收到的脉冲的模式对应于预定义的脉冲模式之一之后,并且如果这样设置,则在确定出接收到的脉冲模式中没有错误或者显着错误之后,LCP 402可以确定已经接收到有效消息。如果LCP 402确定已经接收到有效消息,则LCP 402可以在框706处再次开始该方法,诸如通过跟随框714的“是”分支。
如果尚未接收到有效消息,则LCP 402可以确定脉冲计数是否大于脉冲计数阈值,如在716处所示。可以将脉冲计数阈值设置为高于LCP 402可能以有效消息而接收到的脉冲的最大数量。例如,如果每个消息可以对应于预定义的脉冲模式或序列,则可以存在可以以给定消息发送的脉冲的最大数量。因此,如果LCP 402在通信窗口内接收到高于脉冲计数阈值的脉冲数量,则LCP 402可以推断传导通信信号550已被噪声破坏。因此,如果LCP 402确定脉冲计数已经超过脉冲计数阈值,则LCP 402可以增加接收阈值505的值并且重置脉冲计数,如在718处所示,并且在步骤704再次开始方法700。LCP 402可以基于针对接收到的脉冲的数量花费多长时间超过脉冲计数阈值、基于接收到的脉冲的数量超过了脉冲计数阈值多少、和/或基于根据任何其他合适标准,而将接收阈值505的值增加预定量。如果脉冲计数没有超过脉冲计数阈值,则LCP 402可以循环回到步骤708并继续计数接收到的脉冲。
在一些情况下,LCP 402可以等待直到通信窗口结束,以确定是否接收到有效消息以及脉冲计数是否超过脉冲计数阈值。例如,框714和716可以连接到“是”分支框712,使得LCP 402仅在通信窗口定时器超过通信窗口定时器阈值之后确定是否接收到有效消息并且脉冲计数是否超过脉冲计数阈值。然后框720可以连接到框716的“否”分支。
LCP 402可以被配置成至少部分地基于传导通信信号500的幅度来调整接收阈值505。以适当的水平设置接收阈值505有效地过滤掉传导通信信号550中的噪声分量504。在操作中,方法700可以致力于增加接收阈值505高于噪声分量504的峰值幅度,使得噪声分量504的峰值低于接收阈值505,使得比较器电路在传导通信信号550中不产生相应的脉冲。然而,接收阈值505可以保持在信号分量502的峰值幅度以下,使得比较器电路确实在传导通信信号550中产生与信号分量502中的脉冲对应的脉冲。
图8描述了当接收阈值505已经被设置为高于噪声分量504的最大幅度但低于信号分量502的最大幅度时表示比较器电路的输出的传导通信信号550a。可以看出,传导通信信号550仅包括由于传导通信信号500的信号分量502引起的脉冲。当如此设置时,LCP 402可以将传导通信信号550a解释为有效消息。
图9描绘LCP 402(或另一装置)可用以调整接收阈值505的另一说明性方法750的流程图。在此情况下,可至少部分地基于传导通信信号500的幅度来调整接收阈值505。在说明性方法750中,LCP 402可以从另一个装置(例如外部支持装置420)接收常规消息。在一个示例中,可以在每个通信窗口期间接收至少一个消息。
如方法700所示,通过将接收阈值505设置为初始值,重置和开始通信窗口定时器,并且重置并开始通信会话定时器(如分别在752、754和756处所示),LCP 402可以开始。接下来,LCP 452可以确定通信会话定时器是否已经超过通信会话定时器阈值,如在758处所示。
如果LCP 402确定通信窗口会话定时器未超过通信窗口会话阈值,则如在760处所示,LCP 402可以确定通信窗口定时器是否已超过通信窗口定时器阈值。如果LCP 402确定通信窗口定时器没有超过通信窗口定时器阈值,则LCP 402可以确定是否已经接收到有效消息,如在764处所示。如果没有接收到有效消息,则LCP 402可以循环回到框758。以这种方式,LCP 402可以继续校验在通信窗口期间是否接收到有效消息。
如果LCP 402确定通信窗口定时器已经超过通信窗口定时器阈值,则LCP 402可以确定在通信窗口期间是否接收到至少一个有效消息。如果没有接收到有效消息,则LCP 402可以增加接收阈值505并且重置并开始通信窗口定时器,如在766处所示,并且在758处再次开始方法750。基于针对接收到的脉冲的数量花费多久超过脉冲计数阈值,或基于其他标准,LCP 402可以将接收阈值505的值增加预定量。如果LCP 402确定已经接收到至少一个有效消息,则LCP 402可以在框754处再次开始方法750。
以这种方式,如果接收阈值505被设置得太低,例如,低于噪声分量504的最大幅度,则LCP 402将不会轻易接收到有效消息并且然后将增加接收阈值505。这将继续,直到接收阈值505被设置为高于噪声分量504的幅度并且LCP 402可以开始仅基于信号分量502接收有效消息。
在一些情况下,在确定是否已接收到有效消息之前,LCP 402可以等待直到通信窗口定时器已经超过通信窗口定时器阈值之后。例如,方法750根本可以不包括框764。相反,框760的“否”分支可以直接连接到框756。
在一些情况下,在确定出脉冲计数是否超过脉冲计数阈值或者是否接收到有效消息之前,LCP 402可以等待比单个通信窗口时段更长的时间。例如,在进行任何确定之前,LCP 402可以等待直到两个、三个或甚至四个通信窗口已经过去。这些只是图9所示方法的一些示例性替代方案。
图10描绘了用于调整接收阈值505的另一种方法。图10描绘了传导通信信号500以及动态接收阈值505A,其中动态接收阈值505A被重置为传导通信信号500的每个峰值上的超过当前动态接收阈值505A的新值。
在图10的示例中,动态接收阈值505A可以被设置为初始值并且可以被配置为随着时间衰减到更低的值。应该理解的是,图10中描绘的动态接收阈值505A的衰减形状可以只是一个示例。在一个非限制性示例中,动态接收阈值505A可以在100ms之后衰减到其初始值的大约一半,并随后在接下来的100ms内衰减到其初始值的大约四分之一。具体的衰减值和时间段可能不同。预期的是动态接收阈值505A可以以对数或自然对数方式,以指数方式,以逐步方式或任何其它期望的方式衰减。
可以看出,动态接收阈值505A被配置为在传导通信信号500达到高于当时现有动态接收阈值505A的峰值幅度之后衰减。例如,在图10中,动态接收阈值505A在峰值800处和峰值801的末端处开始衰减。当传导通信信号500达到高于当时现有动态接收阈值505A的新峰值幅度时,LCP 402可将动态接收阈值505A重置为新的更高值。在一些实施例中,随着传导通信信号500持续提供超过衰减动态接收阈值505A的峰值,LCP 402可以持续地将动态接收阈值505A重置为新的更高值。可以看出,一旦传导通信信号500开始幅度下降,动态接收阈值505A将开始衰减。在一些实施例中,动态接收阈值505A可以被配置为在被设置为新值之后在一个短预定时间段内等待衰减。在一些情况下,替代了将动态接收阈值505A持续重置为新的更高值,而是LCP 402可以等待以确定传导通信信号500的峰值。在一些情况下,重置动态接收阈值505A的新的更高值可能滞后传导通信信号500一个短时间段。
在一些情况下,替代了将动态接收阈值505A设置为传导通信信号500的最近峰值的值,而是LCP 402可以将动态接收阈值505A设置为与传导通信信号500的最近峰值成比例的值。例如,LCP 402可以将动态接收阈值505A设置为在最近峰值的最大值的60%-99%之间的值。这只是一个示例。其他示例包括传导通信信号500的最近峰值的最大值的70%-99%,80%-99%或90%-99%之间。
在一些情况下,动态接收阈值505A的衰减特性可以至少部分地基于传导通信信号500的特性。例如,动态接收阈值505A可以被配置为针对动态接收阈值505A的更高值而更快地衰减。在另一个示例中,动态接收阈值505A可以被配置为,自动态接收阈值505A已经被重置起,时间越久就更快地衰减,这将对应于传导通信信号500的较长周期的低幅度活动。这些仅仅是示例。
在一些替代实施例中,LCP 402可将接收阈值调整为其中LCP 402检测到其成功接收通信信号但不接收噪声信号的值。例如,LCP 402可以发起搜索算法以便调整诸如阈值505或505a的接收阈值。在一些实施例中,算法可以以逐步方式具有接收阈值衰减,并且衰减步骤之间的时间可以在约4ms到约10,000ms之间的范围内。4ms值可以代表最短长度的通信。10,000ms值可以代表可能影响信噪比的缓慢呼吸周期。然而,在其他实施例中,衰减步长之间的时间可以具有4ms和10,000ms之间的任何值。在一些实施例中,每个步长处的衰减可以以二进制比率发生,例如1/16,1/32,1/64,1/128或1/256等。例如,在每个衰减步长处,接收阈值505a可以衰减接收阈值505a的当前值的所选的1/16(或其他所选的二进制比率)。在进一步的实施例中,衰减值可以在连续的步长中改变。例如,第一衰减量可以是接收阈值505a的1/256,第二衰减量可以是接收阈值505a的1/128,并且第三衰减量可以是接收阈值505a的1/64等。一旦LCP 100将接收阈值设置为其中LCP 100确定出其正接收在接收到的通信信号中的信号分量和噪声分量两者的值,则LCP 100可将接收阈值设置为先前值,在该先前值中LCP 100未检测到在接收到的通信信号中的信号分量和噪声分量。一个特别有用的实施例可以包括将衰减步长之间的时间设置在25ms并且将衰减值设置为1/64。但是,这只是一个示例。
在一些情况下,LCP 402可以采用自适应滤波器来帮助滤除噪声分量504。如所描述的,外部除颤器406的贴片完整性信号可以是具有总体上静态特性(例如频率和/或幅度)的连续信号。在这种情况下,LCP 402可以在通信时段之外感测贴片完整性信号。然后,LCP402可以处理贴片完整性信号以至少确定信号的频率,并且可以将自适应滤波器配置到以贴片完整性信号的频率为中心的陷波滤波器(notch filter)中。在贴片完整性信号具有单一频率或窄频谱的情况下,陷波滤波器可以在滤除噪声分量504或者至少减小其幅度而言是特别有效的。
虽然这些技术通常是分开描述的,但是在一些情况下,LCP 402可以同时采用多个所公开的技术。例如,除了动态接收阈值之外,LCP 402还可以实施上述的脉冲计数方法。在另一个示例中,LCP 402可以实施脉冲计数方法以及自适应滤波器。通常,在不同的实施例中,LCP 402可以包括上述技术的所有组合。
应该理解,虽然上述方法是以LCP 402作为接收器并且外部支持装置420作为发射器来描述的,但这仅仅是为了说明的目的。在一些情况下,外部支持装置420可以充当接收器并且可以实施关于LCP 402所描述的任何技术。另外,应当理解,所描述的技术不限于***400。实际上,所描述的技术可以通过使用了传导通信的任何装置和/或***来实施。
在一些情况下,***400(或其他***)的一个或多个装置可以被配置为主动地抵消贴片完整性信号。例如,在图4的示例中,替代***400的装置调整接收阈值或自适应滤波器(或除了这个之外),而***400的一个或多个装置(还)可以向患者体内注入抵消信号或反相信号以抵消或至少减小由外部除颤器406递送的贴片完整性信号的幅度。下面的描述仅使用外部支持装置420作为可以执行所描述技术的装置的一个示例。然而,应该理解,在此描述的技术可以由***400的任何装置应用,或者根据需要由其他***中的其他装置应用。
图11A描绘了可由外部除颤器406递送的示例贴片完整性信号810信号。外部支持装置420可在患者体内的相对电安静时段期间感测传播通过患者身体的信号,包括贴片完整性信号810。例如,外部支持装置420可以在患者心跳之间经由电极404感测在患者中的传播的电信号,而同时没有传导通信信号传播通过患者身体。在贴片完整性信号810与传播通过患者身体的其他信号充分不同的情况下,外部支持装置420可以采用一个或多个滤波器来滤除除贴片完整性信号810以外的信号,仅留下贴片完整性信号810。例如,外部支持装置420可以采用一个或多个低通、高通、带通、陷波和/或任何其他合适的滤波器。外部支持装置420可以确定贴片完整性信号810的各种特征。例如,外部支持装置420可以确定贴片完整性信号810的频率分量、幅度和/或相位。
在一些情况下,外部支持装置420可以包括脉冲发生器模块,由此外部支持装置420可以生成变化的波形。在外部支持装置420感测到贴片完整性信号810之后,外部支持装置420可以使用所确定的特性来生成抵消或反相信号812(参见图11B)。例如,外部支持装置420可以生成反相信号812以具有与贴片完整性信号810相似的幅度和频率。然而,外部支持装置420可以在相对于反相信号812移位一百八十度的相位处生成反相信号812。在图11B中描绘了反相信号812的示例。如果贴片完整性信号810不是如图11A所示的规则信号,则外部支持装置420可以简单地生成将抵消补偿完整性信号810或者至少减小其幅度的反相信号812。其他示例反相信号可以包括作为贴片完整性信号810的并不纯粹反相的信号。例如,反相信号在被添加到贴片完整性信号时可以减小在包括了外部支持装置420的***的装置处接收到的贴片完整性信号的幅度。可替选地,反相信号在被添加到贴片完整性信号时可以产生由包括了具有比原始贴片完整性信号增加的频率的外部支持装置420的***的装置接收到的信号。贴片完整性信号的这种增加的频率可以允许信号被接收装置更容易地过滤掉。因此,尽管整个本公开中的描述可能集中于或讨论作为贴片完整性信号的纯粹反相信号的或与纯粹反相信号近似的反相信号,但应当理解,这仅仅是为了便于描述。通常,外部支持装置420可以生成不是纯粹反相信号的反相信号,但是足以干扰或改变贴片完整性信号以允许接收装置区分贴片完整性信号和通信信号,或者在没有过滤掉通信信号的情况下过滤掉贴片完整性信号。
外部支持装置420可以例如通过电极404将所生成的反相信号812递送到患者的身体中。因为反相信号812具有与贴片完整性信号810类似但相反的特征,所以反相信号812可以破坏性地干扰贴片完整性信号810,从而抵消和/或至少减小由连接到患者的其他装置(例如LCP 402)感测到的贴片完整性信号810的幅度。在一些示例中,反相信号812可以与贴片完整性信号810完全相反并且可以完全抵消反相信号812,使得LCP 402不感测贴片完整性信号810。在其他示例中,反相信号812可以仅与贴片完整性信号810类似,并且可以仅减小由LCP 402感测到的贴片完整性信号810的幅度。在任何情况下,递送的反相信号812可以减小由LCP 402感测到的贴片完整性信号810的幅度,这可以增强外部支持装置420与LCP402之间(和/或LCP 402与另一个植入装置之间)传导通信的信噪比(SNR)。在外部支持装置420正递送反相信号812时由LCP 402感测到的信号的示例在图12中示出为信号814。
在至少一些实施例中,代替试图匹配贴片完整性信号810的幅度,而是外部支持装置420可以生成具有与贴片完整性信号810不同的幅度的反相信号812。除了外部支持装置420之外连接到患者的装置(诸如LCP 402)感测到的贴片完整性信号810的幅度可以不同于由外部支持装置420感测到的完整性信号810的幅度。因此,以与由外部支持装置420感测到的贴片完整性信号810类似的幅度向患者递送反相信号812可以抵消由LCP 402感测到的贴片完整性信号810,但是可能额外地引入反相信号812形式的噪声,这未被贴片完整性信号810完全抵消。在一些情况下,外部支持装置420可以生成具有比由外部支持装置420感测到的贴片完整性信号的幅度更高或更低的幅度的反相信号812。外部支持装置420可以尝试将由LCP 402感测到的反相信号812的幅度与由LCP 402感测到的贴片完整性信号810的幅度匹配。例如,外部支持装置420可以基于从LCP 402接收到的反馈或基于来自LCP 402的接收到的消息的存在或不存在来调整反相信号812的幅度。在其他实施例中,外部支持装置420可以包括物理拨号或增益调整器424,用户可以调整它以增加或减小所生成的反相信号812的幅度(见图13)。
通过抵消或减少身体中的贴片完整性信号810,将反相信号812递送到患者体内可以增强与身体的传导通信的信噪比(SNR)。在一些实施例中,外部支持装置420可以连续地将反相信号812递送到患者体内。在其他情况下,在当由外部除颤器406感测到的贴片完整性信号810可以被完全抵消或幅度减小到低于特定警报阈值时,所递送的反相信号812可以使外部除颤器406生成或发出警报。因此,在一些情况下,外部支持装置420可以仅选择性地将反相信号812递送到患者体内。例如,在外部支持装置420或LCP 402正将传导通信信号递送到患者体内时,外部支持装置420可以仅将反相信号812递送到患者体内。在一些情况下,LCP 402可以在所递送的传导通信信号与贴片完整性信号810之间具有更容易的时间上区分。在一些情况下,外部支持装置420和LCP 402的传导通信方案可以包括仅在预定义时段期间递送传导通信信号。例如,外部支持装置420和LCP 402可以被配置为仅在持续大约100ms的通信窗口期间递送传导通信信号,其中每个通信窗口相隔800ms。这些数字只是示例。通信窗口的长度和间隔可以是任何合适的值。
在一些情况下,通信窗口可以与心脏电信号的一个或多个特征同步。例如,外部支持装置420和LCP 402可以被配置为在每个检测到的R波之后发生大约100-250ms的通信窗口期间进行通信。外部支持装置420可以被配置为仅在这些通信窗口期间将反相信号812递送到患者体内。外部支持装置420和LCP 402都可以受益于感测到的传导通信信号与贴片完整性信号810之间的增强的区分。
图11A中描绘的贴片完整性信号810只是一个示例。目前市场上的不同外部除颤器可以使用不同形状的贴片完整性信号。因此,在一些实施例中,代替具有能够生成任何或大量不同类型波形的通用波形发生器,而是外部支持装置420可以包括硬件或电路,其可以生成用在可用的外部除颤器中的各种不同的已知贴片完整性信号的反相信号。
图13描述了外部支持装置420的示例界面。外部支持装置420可以包括转盘、开关或其他机械选择器(例如转盘424)或图形用户界面422中的菜单选项,其允许用户从对应于不同可用外部除颤器的一组预编程反相波形中选择特定反相波形。预编程反相波形可以被存储在外部支持装置420的存储器中。每个可选波形可以具有使波形与特定品牌或产品相关的标识符,以便容易地识别适当的反相波形。这些特征可以允许外部支持装置420比需要外部支持装置420感测贴片完整性信号并且随后使用通用波形发生器产生反相信号时的情况更简单且制造成本更低。
图14描绘了***900,其可以有助于增强传导通信信号和噪声信号例如贴片完整性信号之间的区分。***900可以包括外部支持装置920,外部除颤器906和切换单元910。外部除颤器906可以通过导线908连接到切换单元910,并且外部支持装置920可以通过导线922连接到切换单元910。切换单元910可以通过导线912连接到被附接到患者皮肤915的电极904。
在***900中,切换单元910可以被配置为在来自外部支持装置920的导线922与来自外部除颤器906的导线908之间进行切换,以将每个装置连接到/断开到电极904。切换单元910可以初始地将导线908连接到电极904,以允许外部除颤器906通过电极904递送贴片完整性信号并通过皮肤915进入患者。在一些情况下,当外部支持装置920是将传导通信信号递送到患者时,切换单元910可断开外部除颤器906的导线908与电极904的连接并且将导线922从外部支持装置920连接到电极904。在该配置中,外部支持装置920可以通过电极904将传导通信信号递送到患者体内。在外部除颤器906与电极904断开的情况下,贴片完整性信号被有效地阻止进入患者,并且装置可通过传导通信信号进行通信而不受来自贴片完整性信号的干扰。一旦传导通信信号已经被发送和接收,切换单元910就可以断开外部支持装置920的导线922与电极904的连接并且将外部除颤器906的导线908连接到电极904。外部除颤器906的贴片完整性信号然后可以被递送给患者,以向外部除颤器906验证贴片电极904充分与皮肤电连通。如果通信时段保持足够短,则可以不触发外部除颤器906的贴片验证警报。
在一些情况下,外部支持装置920可以控制切换单元910以将导线908、922与导线912连接/断开。在其他情况下,外部除颤器906可以控制切换单元910,不同的装置可以控制切换单元910,或者外部除颤器906和外部支持装置920二者可以控制切换单元910。为了便于描述,从控制切换单元910的外部支持装置920的角度来描述该技术。
在操作中,外部除颤器906通常可以连接到电极904以传送贴片完整性信号和/或感测心脏电信号。在外部支持装置920将传导通信信号递送到患者体内之前,外部支持装置920可以命令切换单元910断开外部除颤器906的导线908与电极904的连接并且将外部支持装置920的导线922连接到电极904,从而阻断来自外部除颤器906的贴片完整性信号被递送给患者。一旦外部支持装置920完成递送传导通信信号,外部支持装置920就可命令切换单元910将外部除颤器906的导线908重新连接到电极904。
在一些情况下,代替在外部支持装置920将传导通信信号递送到患者之前,仅命令切换单元910将外部支持装置920的导线922连接到电极904,而是外部支持装置920可使得切换单元910以有规律间隔进行切换。例如,在外部支持装置920和另一装置(诸如LCP装置)连接到患者并且被配置为仅在预定义的通信窗口期间使用传导通信进行通信的一些情况下,外部支持装置920可以命令切换单元910在每个通信窗口期间将外部支持装置920的导线922连接到电极904。
当外部除颤器906的导线908从电极904断开时,导线908可形成开路,其可导致外部除颤器906产生或发出警报,因为外部除颤器906可能不再感测到贴片完整性信号。在一些实施例中,为了帮助防止外部除颤器906产生警报,当切换单元910断开外部除颤器906的导线908与电极904的连接时,切换单元910可以将导线908直接连接在一起,或者可以通过包含在切换单元910内的电阻性或其它网络而将导线908连接在一起。在这些实施例中,切换单元910可保持用于贴片完整性信号的闭环,这可有助于防止外部除颤器906产生或发出警报。
虽然***900被描绘为包括外部除颤器906,切换单元910和外部支持装置920,但是可以预期的是***900可以包括更少或更多的装置。例如,外部支持装置920的支持功能和切换单元910的切换功能可以被构建到外部除颤器906中。当如此设置时,外部除颤器906可以具有内部切换机构并且可以控制切换机构以助于支持在患者内经由其他装置的传导通信。
总体上,本领域的那些技术人员将认识到除在本文中描述和设想的具体示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)
1.一种与在患者内植入的医疗装置进行通信的方法,包括:
在医疗装置处经由连接到所述患者的电极接收传导通信信号,其中所述传导通信信号包括信号分量和噪声分量,所述信号分量包括脉冲格式下的多个通信脉冲,且所述噪声分量包括噪声信号;
确定所接收的传导通信信号是否包括与通信脉冲的脉冲格式不匹配的一个或多个脉冲,并且当是这样时,由所述医疗装置调整接收阈值以从所接收的传导通信信号进一步过滤掉噪声信号。
2.根据权利要求1所述的方法,其中调整所述接收阈值包括:
由所述医疗装置在通信窗口期间对所述传导通信信号中的具有大于所述接收阈值的幅度的脉冲数量进行计数;
由所述医疗装置确定所计数的脉冲数量是否超过脉冲计数阈值;和
在确定出所计数的脉冲数量超过所述脉冲计数阈值之后,由所述医疗装置增加所述接收阈值。
3.根据权利要求2所述的方法,其中所述脉冲计数阈值表示能够形成消息的脉冲的最大数量。
4.根据权利要求2-3中的任一项所述的方法,还包括在确定出所计数的脉冲数量超过所述脉冲计数阈值之后,由所述医疗装置开始新的通信窗口。
5.根据权利要求2-3中的任一项所述的方法,还包括由所述医疗装置:
跟踪通信会话定时器;和
在确定出所述通信会话定时器已经达到阈值之后,由所述医疗装置将所述接收阈值设置为较低的预定值。
6.根据权利要求5所述的方法,还包括在成功接收消息之后,由所述医疗装置重置所述通信会话定时器。
7.根据权利要求1-3中的任一项所述的方法,其中调整所述接收阈值包括:
在通信窗口定时器达到阈值之后,由所述医疗装置确定在所述通信窗口定时器达到所述阈值之前是否接收到消息,其中所述消息表示所述通信信号中的、每个都具有高于所述接收阈值的幅度的脉冲的预定序列中的多个通信脉冲;和
在确定出在所述通信窗口定时器达到所述阈值之前没有接收到消息之后,由所述医疗装置增加所述接收阈值。
8.根据权利要求7所述的方法,其中增加所述接收阈值包括将所述接收阈值增加预定量。
9.根据权利要求7所述的方法,还包括:
在所述通信窗口定时器达到所述阈值之前,由所述医疗装置确定是否已经接收到消息;和
在确定出在所述通信窗口定时器已经达到所述阈值之前已经接收到消息之后,由所述医疗装置重置所述通信窗口定时器值。
10.根据权利要求9所述的方法,还包括:
由所述医疗装置跟踪通信会话定时器;和
在确定出所述通信会话定时器已经达到阈值之后,由医疗装置将所述接收阈值设置为较低的预定值。
11.根据权利要求10所述的方法,还包括在确定出已经接收到消息之后,由所述医疗装置重置所述通信会话定时器。
12.根据权利要求1-3中的任一项所述的方法,其中调整所述接收阈值包括:由所述医疗装置将所述接收阈值设置为与具有高于所述接收阈值的幅度的通信信号的脉冲的最大幅度成比例的值。
13.根据权利要求12所述的方法,其中将所述接收阈值设置为与具有高于所述接收阈值的幅度的通信信号的脉冲的最大幅度成比例的值包括:将所述接收阈值设置为具有高于所述接收阈值的幅度的通信信号的脉冲的幅度的最大值。
14.根据权利要求12所述的方法,还包括:由所述医疗装置将所述接收阈值设置为与具有高于所述接收阈值的幅度的通信信号的每个脉冲的最大幅度成比例的值。
15.根据权利要求12所述的方法,其中所述接收阈值根据预定函数衰减。
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CN108136186A (zh) | 2018-06-08 |
EP3337558A1 (en) | 2018-06-27 |
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