CN108472490B - 医疗设备系统中的传导通信 - Google Patents
医疗设备系统中的传导通信 Download PDFInfo
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
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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
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37288—Communication to several implantable medical devices within one patient
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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
- A61N1/372—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
Abstract
一种用于在植入患者内的可植入医疗设备可以包括:外壳;至少部分地设置在外壳内的脉冲发生电路;电耦合到脉冲发生电路的多个电极,所述多个电极暴露在外壳的外部;以及可操作地耦合到脉冲发生电路的控制器。所述控制器可以被配置为命令脉冲发生电路经由多个电极中的至少两个来递送相位传导通信脉冲。另外,相位传导通信脉冲可以包括具有第一极性的第一相位,接着是具有相反的第二极性的第二相位,其中第二相位可以具有小于60微秒的持续时间,并且其中第一相位可以具有所述第二相位的持续时间的5%和80%之间的持续时间。
Description
相关申请的交叉引用
本申请要求于2015年12月17日提交的美国临时专利申请序列号62/268,751的权益,其公开内容通过引用并入本文。
技术领域
本公开通常涉及医疗设备,并且更具体地涉及多设备系统中的医疗设备之间的传导通信。
背景技术
可植入医疗设备一般用于监视、诊断和/或治疗身体中的各种状况。这种设备可以包括,例如神经刺激器、诊断设备、化学传感器、压力传感器、温度传感器等。起搏设备是另一示例。起搏设备用于治疗患有各种心脏状况的患者。许多心脏状况能够导致快速、不规律和/或低效率的心脏收缩。为了帮助减轻这些心脏状况中的一些心脏状况,通常将各种心脏刺激/传感器设备(例如起搏器、除颤器等)植入到患者体内。然后,这种设备用于监视并向心脏提供电刺激,以帮助心脏以更正常、有效和/或安全的方式运作。
无论可植入设备的类型如何,通常都期望与植入设备建立通信。在一些情况下,使用传导通信,其依赖于通过身体“传导”的电通信信号或脉冲。在一些情况下,这种电通信信号或脉冲会不期望地刺激身体组织。将期望的是改进的传导通信方案不太可能刺激身体组织。
发明内容
本公开通常涉及用于与可植入医疗设备进行通信或可植入医疗设备之间进行通信的系统、设备以及方法。在第一说明性实施例中,用于植入到患者内的可植入医疗设备可以包括外壳、至少部分地设置在外壳内的脉冲发生电路、电耦合到脉冲发生电路的多个电极(多个电极被暴露在外壳外部)、以及可操作地耦合到脉冲发生电路的控制器。在一些情况下,控制器可以被配置为命令脉冲发生电路经由多个电极中的至少两个递送相位传导通信脉冲。相位传导通信脉冲可以包括具有第一极性的第一相位,接着是具有相反的第二极性的第二相位。第二相位可以具有少于60微秒的持续时间。在一些情况下,第一相位可以具有第二相位的持续时间的5%和80%之间的持续时间。
另外或可替选地,第一相位可以具有第一相位振幅,其中第一相位振幅的绝对值可以在1和15伏之间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第二相位可以具有第二相位振幅,其中第二相位振幅的绝对值可以在1和15伏之间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第一相位可以具有绝对值在2和7伏之间的第一相位振幅,并且第二相位可以具有绝对值在2到7伏之间的第二相位振幅。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第一相位可以具有绝对值在1和4伏之间的第一相位振幅,并且第二相位可以具有绝对值在1和4伏之间的第二相位振幅。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第二相位可以具有小于60微秒的持续时间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第二相位可以具有小于30微秒的持续时间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第二相位可以具有小于20微秒的持续时间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第一相位可以具有第二相位的持续时间的40%和60%之间的持续时间。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第一相位和第二相位每个都可以基本上是矩形脉冲。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第一相位和第二相位每个都可以基本上是矩形脉冲、锯齿形脉冲、指数式脉冲、梯形脉冲或阶梯式脉冲。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,相位传导通信脉冲可以包括第三相位。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,第三相位可以具有第一极性。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,相位传导通信脉冲可以基本上电荷平衡。
另外或可替选地,在关于第一说明性实施例的上述实施例的任一个中,相位传导通信脉冲可以具有四个或四个以上的相位。
在第二说明性实施例中,医疗设备可以包括外壳,至少部分地设置在外壳内的脉冲发生电路、电耦合到脉冲发生电路的多个电极(多个电极被暴露在外壳外部)、以及可操作地耦合到脉冲发生电路的控制器。在一些情况下,控制器可以被配置为命令脉冲发生电路经由多个电极中的至少两个递送相位传导通信脉冲。另外,在一些情况下,相位传导通信脉冲可以包括至少三个相位。
另外或可替选地,关于第二说明性实施例,相位传导通信脉冲可以包括第一相位、第二相位以及第三相位,其中每个相位具有持续时间和振幅,并且其中第一相位和第三相位可以具有第一极性且第二相位可以具有第二相反极性。
另外或可替选地,在关于第二说明性实施例的上述实施例的任一个中,第二相位的持续时间可以小于60微秒。
另外或可替选地,在关于第二说明性实施例的上述实施例的任一个中,相位传导通信脉冲的第一相位的持续时间可以在相位传导通信脉冲的第二相位的持续时间的5%和80%之间。
另外或可替选地,在关于第二说明性实施例的上述实施例的任一个中,第二相位的持续时间可以小于50微秒,并且第一相位的持续时间可以在第二相位的持续时间的40%和60%之间。
另外或可替选地,在关于第二说明性实施例的上述实施例的任一个中,相位传导通信脉冲可以基本上电荷平衡。
另外或可替选地,在关于第二说明性实施例的上述实施例的任一个中,相位传导通信脉冲可以具有四个或更多个相位,四个或更多个相位中的每个都具有持续时间。
在第三说明性实施例中,医疗设备可以包括外壳、耦合到外壳的多个电极以及电连接到多个电极的通信电路。在至少一些情况下,通信电路可以被配置为经由多个电极中的两个或更多个递送相位传导通信脉冲,以用于通信医疗设备外部的信息。在至少一些情况下,相位传导通信脉冲可以包括第一相位,随后是第二相位,随后是第三相位,其中第一相位和第三相位具有第一极性,并且第二相位具有相反的第二极性。
另外或可替选地,关于第三说明性实施例,第二相位可以具有小于60微秒的持续时间,并且第一相位可以具有第二相位的持续时间的5%和80%之间的持续时间。
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。通过参考以下结合附图的描述和权利要求,优点和成就以及本公开的更全面了解,将变得显而易见并被理解。
附图说明
考虑到以下结合附图的各种说明性实施例的描述,可以更全面地了解本公开,在附图中:
图1是根据本公开的一个示例实施例的说明性无引线心脏起搏器(LCP)的示意性框图;
图2是可以结合图1的LCP使用的另一说明性医疗设备的示意性框图;
图3是包括彼此通信的多个LCP和/或其它设备的说明性医疗系统的示意图;
图4是根据本公开的另一实施例的包括LCP和另一医疗设备的系统的示意图;
图5A-5B描绘了具有矩形相位形态的说明性双相传导通信脉冲;
图6A描绘了具有锯齿形相位形态的说明性双相传导通信脉冲;
图6B描绘了具有指数式相位形态的说明性双相传导通信脉冲;
图6C描绘了具有梯形相位形态的说明性双相传导通信脉冲;
图6D描述了具有阶梯式相位形态的说明性双相传导通信脉冲;
图7描绘了展示一个说明性信息编码方案的通信脉冲序列;
图8描绘了展示另一说明性信息编码方案的另一通信脉冲序列;
图9A-9B描绘了说明性三相传导通信脉冲;
图10A-10B描绘了说明性四相传导通信脉冲;
图11A-11B描绘了说明性六相传导通信脉冲;以及
图12示出了从犬收集的数据的曲线图,其示出了各种不同脉冲形态的心脏捕获阈值对于脉冲宽度持续时间。
尽管本公开服从各种修改和替选形式,但其细节已经通过附图中的实施例的方式示出并且将被详细描述。然而,应该理解的是,意图不是将本公开的方面限制于所述的特定说明性实施例。相反,意图是覆盖落入到本公开的精神和范围内的所有修改、等同物以及替选方案。
具体实施方式
应该参考附图来阅读以下描述,其中不同附图中的类似元件编号相同。不一定按比例的描述和附图描绘了说明性实施例并且不旨在限制本公开的范围。
本公开涉及用于与可植入医疗设备(诸如心脏刺激设备、神经刺激器、诊断设备、化学传感器、压力传感器、温度传感器等)通信或在可植入医疗设备之间通信的系统、设备以及方法。仅仅为了方便,本文描述的许多示例针对心脏刺激设备,诸如可植入起搏器和/或可植入心脏复律器-除颤器。意图不是将本公开限制为可植入起搏器和/或可植入心脏复律器-除颤器。相反,意图是覆盖与任何合适的可植入医疗设备的通信或任何合适的可植入医疗设备之间的通信。
图1是说明性无引线心脏起搏器(LCP)的概念性示意性框图,所述说明性无引线心脏起搏器可以植入在心脏上或心脏腔室内,并且可以操作以感测生理信号和参数并将一个或多个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、频率(rate)响应起搏治疗、心脏再同步治疗(CRT)、抗心动过速起搏(ATP)治疗和/或类似治疗。如图1中所看到的,LCP 100可以是紧凑型设备,其中所有组件都容纳在LCP 100内或直接在外壳120上。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、以及电极114。
如图1所示,LCP 100可以包括电极114,电极114可以相对于外壳120固定并且电暴露于LCP 100周围的组织和/或血液。电极114通常可以将电信号传导到LCP 100和周围组织和/或血液,并从LCP 100和周围组织和/或血液传导电信号。这种电信号可以包括通信信号、电刺激脉冲、以及内在心脏电信号,仅举几例。内在心脏电信号可以包括由心脏生成的电信号并且可以由心电图(ECG)表示。
电极114可以包括一个或多个生物相容性导电材料,诸如已知安全植入到人体内的各种金属或合金。在一些情况下,电极114可以通常设置在LCP 100的任一端上,并且可以与模块102、104、106、108以及110中的一个或多个模块电通信。在电极114直接固定到外壳120的实施例中,绝缘材料可以将电极114与相邻的电极、外壳120和/或LCP 100的其它部分电隔离。在一些情况下,电极114中的一些或全部可以从外壳120中隔开并通过连接导线连接到外壳120和/或LCP 100的其它组件。在这种情况下,电极114可以放置在远离外壳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可以包括电极114'。电极114'是除了电极114之外的电极,或者可以取代电极114中的一个或多个。除了电极114'设置在LCP 100的侧面上,电极114'可以类似于电极114。在一些情况下,电极114″可以增加电极的数量,通过该电极,LCP 100可以递送通信信号和/或电刺激脉冲,和/或可以感测内在心脏电信号、通信信号和/或电刺激脉冲。
电极114和/或114'可以假定各种大小和/或形状中的任一种,并且可以以各种间距中的任何间距隔开。例如,电极114可以具有2到20毫米(mm)的外径。在其它实施例中,电极114和/或114'可以具有两毫米、三毫米、五毫米、七毫米(mm)的直径,或者任何其它合适的直径、尺寸和/或形状。电极114和/或114'的示例长度可以包括,例如一毫米、三毫米、五毫米、十毫米(mm)或任何其它合适的长度。如本文所使用的,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毫米、三十毫米、四十毫米、五十毫米(mm)的距离,或任何其它合适的间距。单个设备的电极114和/或114'可以具有相对于彼此不同的大小,并且设备上的电极的间距和/或长度可以是均匀的或者可以不是均匀的。
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',并且可以被配置为将通信脉冲递送到患者的组织以用于与其它设备(诸如传感器、编程器、其它医疗设备和/或类似物)通信。如本文所使用的通信信号可以是通过本身或结合一个或多个其它经调制信号将信息传达到另一设备的任何经调制信号。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设备。在一些情况下,通信可以采取由各种时间量所分离的不同通信脉冲的形式。在这些情况中的一些情况下,连续脉冲之间的定时可以传达信息。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它设备递送的通信信号。
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到的数据、使用通信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/或其它功能。在一些情况下,LCP 100可以使用通信信号来通信原始信息、经处理的信息、消息和/或命令、和/或其它数据。原始信息可以包括诸如感测到的电信号(例如感测到的ECG)、从耦合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进行滤波的信号。经处理的信息还可以包括由LCP100和/或另一设备确定的参数和/或事件,诸如经确定的心率、经确定的心跳的定时、其它经确定的事件的定时、阈值交叉点的确定、监视时期的终止、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/或命令可以包括指示另一设备要采取行动的指示等、发送设备的即将发生的动作的通知、从接收设备中读取的请求、向接收设备写入数据的请求、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)还可以包括开关电路,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,以便通信模块102选择哪些电极114和/或114'来递送通信脉冲。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/或任何其它合适的通信方法与其它设备进行通信。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/或其它电荷存储设备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可以包括连接到能量存储模块112的开关电路,并且利用开关电路,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。如本文所使用的电刺激脉冲意在涵盖为了治疗任何类型的疾病或异常的目的而可以被递送到患者组织的任何电信号。例如,当用于治疗心脏病时,脉冲发生器模块104可以生成电刺激起搏脉冲以用于捕获患者心脏(即响应于所递送的电刺激脉冲引起心脏收缩)。在这些情况中的一些情况下,例如在频率适应性起搏中,LCP 100可以改变脉冲发生器模块104生成电刺激脉冲所处的频率。在其它实施例中,电刺激脉冲可以包括除颤/复律脉冲,以用于对心脏电击去除纤颤或变为正常心律。在另外的其它实施例中,电刺激脉冲可以包括抗心动过速起搏(ATP)脉冲。应该明白,这些只是一些示例。当用于治疗其它疾病时,脉冲发生器模块104可以生成适合于神经刺激治疗等的电刺激脉冲。脉冲发生器模块104可以包括一个或多个电容器元件和/或其它电荷存储设备以帮助生成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可以包括连接到能量存储模块112的开关电路,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可以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器放大器等接收通过电极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其中植入LCP 100的腔室的局部信息。例如,如果将LCP 100植入在心脏的心室内,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它传感器。当存在时,机械感测模块108可以从传感器收集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到处理模块110。虽然关于图1描述为单独的感测模块,但在一些实施例中,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以被认为是LCP 100的控制器。
处理模块110可以被配置为指导LCP 100的操作,并且在一些实施例中可以被称为控制器。例如,处理模块110可以被配置为从电感测模块106中接收心电信号和/或从机械感测模块108中接收生理信号。基于接收到的信号,处理模块110可以确定,例如心律失常的发生和类型以及其它确定,诸如LCP 100是否已经去除。处理模块110还可以从通信模块102中接收信息。在一些实施例中,处理模块110可以另外使用这种接收到的信息来确定心律失常的发生和类型和/或其它确定,诸如LCP 100是否已经去除。在另外的一些附加实施例中,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中接收到的信号更精确,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LCP100省略,则LCP100可以使用接收到的信息代替从电感测模块106和/或机械感测模块108中接收到的信号。
在确定心律失常发生之后,处理模块110可以控制脉冲发生器模块104根据一个或多个电刺激治疗来生成电刺激脉冲以治疗所确定的心律失常。例如,处理模块110可以控制脉冲发生器模块104利用变化的参数并以不同的序列生成起搏脉冲,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以定期的间隔递送被设计为捕捉患者心脏的起搏脉冲,以帮助防止患者心脏低于预定阈值。在一些情况下,起搏频率可以随着患者活动水平的增加而增加(例如频率适应性起搏)。例如,处理模块110可以监视可指示增加心率需要(例如由于代谢需求增加)的患者的一个或多个生理参数。处理模块110然后可以增加脉冲发生器模块104生成电刺激脉冲所处的频率。基于一个或多个生理参数来调整电刺激脉冲的递送频率可以通过仅在生理参数指示需要增加心输出量时要求较高的电刺激脉冲的递送频率来延长LCP 100的电池寿命。另外,调整电刺激脉冲的递送频率可以通过使电刺激脉冲的递送频率与患者的心输出量需要更紧密地匹配来增加患者的舒适水平。
对于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脏电信号而迫使心脏跳动。一旦心脏跟随起搏脉冲,处理模块110就可以控制脉冲发生器模块104以将所递送的起搏脉冲的频率降低到更安全的水平。在CRT中,处理模块110可以控制脉冲发生器模块104以与另一设备协调地递送起搏脉冲,以致使心脏更有效地收缩。在脉冲发生器模块104能够生成用于除颤/复律治疗的除颤和/或复律脉冲的情况下,处理模块110可以控制脉冲发生器模块104生成这种除颤和/或复律脉冲。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生成不同类型的电刺激脉冲并且以不同的序列之外,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振幅。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振幅的各种电刺激脉冲。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/或脉冲振幅。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的递送。
在一些实施例中,处理模块110还可以控制通信模块102将信息发送到其它设备。例如,处理模块110可以控制通信模块102生成用于与设备系统的其它设备进行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,其中特定序列传达不同的信息。通信模块102还可以接收用于处理模块110的潜在动作的通信信号。
在其它实施例中,处理模块110可以控制开关电路,通信模块102和脉冲发生器模块104通过该开关电路将通信信号和/或电刺激脉冲递送到患者的组织。如上所述,通信模块102和脉冲发生器模块104都可以包括用于将一个或多个电极114和/或114'连接到通信模块102和/或脉冲发生器模块104使得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的电路。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中的每个可以包括开关电路,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'的单个开关模块。在这种实施例中,处理模块110可以适当地控制开关模块连接模块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)。在这种实施例中,芯片可以利用控制逻辑进行预编程,以便控制LCP 100的操作。通过使用预编程芯片,处理模块110可以使用比其它可编程电路更少的电力,同时能够保持基本功能,从而潜在地增加LCP 100的电池寿命。在其它情况下,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LCP100的控制逻辑,从而允许LCP 100比使用预编程芯片时更大的灵活性。在另外的其它实施例中,处理模块110可以不是单个组件。例如,处理模块110可以包括定位在LCP 100内的不同位置处的多个组件,以便执行各种所述的功能。例如,某些功能可以在处理模块110的一个组件中执行,而其它功能在处理模块110的单独组件中执行。
在另外的实施例中,处理模块110可以包括存储器电路,并且处理模块110可以将信息存储在存储器电路上并且从存储器电路中读取信息。在其它实施例中,LCP 100可以包括与处理模块110通信的单独的存储器电路(未示出),使得处理模块110可以从单独的存储器电路读取信息并将信息写入单独的存储器电路。无论是处理模块110的部分还是与处理模块110分离,存储器电路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可以将电源提供到LCP 100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锂基电池。在其它实施例中,不可再充电电池可以由其它合适的材料制成。在一些实施例中,能量存储模块112可以包括可再充电电池。在另外的其它实施例中,能量存储模块112可以包括其它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,医师、临床医师等)可以将LCP 100固定到患者心脏的心脏组织。为了便于固定,LCP 100可以包括一个或多个锚固件(anchors)116。在图1中示意性地示出了一个或多个锚固件116。一个或多个锚固件116可以包括任何数量的固定或锚固机构。例如,一个或多个锚固件116可以包括一个或多个大头针、订书钉、螺纹、螺钉、螺旋线、尖齿、和/或类似物。在一些实施例中,虽然未示出,但一个或多个锚固件116可以包括在其外表面上的螺纹,螺纹可沿着锚固构件的至少部分长度行进。螺纹可以在心脏组织和锚固件之间提供摩擦,以帮助将锚固构件固定在心脏组织内。在一些情况下,一个或多个锚固件116可以包括锚固构件,该锚固构件具有可拧入心脏组织中的软木螺钉形状。在其它实施例中,锚固件116可以包括其它结构,诸如倒钩、长钉等,以便于与周围的心脏组织接合。
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,LCP 100可以植入在患者心脏的左心房、右心房、左心室或右心室中的任一个内。通过植入到特定腔室内,LCP 100可以能够感测源自特定腔室的或从特定腔室发出的心电信号,其它设备可能不能用这种分辨率来感测。在LCP100被配置为植入在患者心脏上的情况下,LCP100可以被配置为植入在心脏腔室中的一个上或邻近心脏腔室中的一个,或者内在地生成的心电信号通常跟随的路径上或邻近该路径。在这些示例中,LCP 100还可以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可以另外能够感测LCP 100所附接的心脏壁的运动。
图2描绘了可以操作以感测生理信号和参数并将一个或多个类型的电刺激治疗递送到患者组织的另一设备,医疗设备(MD)200的实施例。在所示的实施例中,MD 200可以包括通信模块202、脉冲发生器模块204、电感测模块206、机械感测模块208、处理模块210、以及能量存储模块218。模块202、204、206、208以及210中的每个可以类似于LCP 100的模块102、104、106、108以及110。另外,能量存储模块218可以类似于LCP 100的能量存储模块112。然而,在一些实施例中,MD 200可以在外壳220内具有较大的体积。在这种实施例中,MD200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。
虽然如图1所示MD 200可以是另一无引线的设备,但在一些情况下,MD200可以包括引线,诸如引线212。引线212可以包括在电极214和位于外壳220内的一个或多个模块之间传导电信号的电导线。在一些情况下,引线212可以连接到MD 200的外壳220并远离MD200的外壳220延伸。在一些实施例中,引线212被植入在患者的心脏上、心脏内或邻近心脏。引线212可以包括一个或多个电极214,其定位在引线212上的各种位置处以及距外壳220的各种距离处。一些引线212可以仅包括单个电极214,而其它引线212可以包括多个电极214。通常,电极214被定位在引线212上,使得当引线212被植入在患者内时,电极214中的一个或多个被定位以执行期望的功能。在一些情况下,电极214中的一个或多个可以与患者的心脏组织接触。在其它情况下,电极214中的一个或多个可以定位在皮下但邻近患者的心脏。电极214可以将内在生成的心电信号传导到引线212。相反,引线212可以将接收到的心电信号传导到MD 200的模块202、204、206以及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到电极214。电极214然后可以将电刺激信号(直接或间接地)传导到患者的心脏组织。MD 200还可以包括一个或多个未设置在引线212上的电极214。例如,一个或多个电极214可以直接连接到外壳220。
在一些实施例中,引线212可以另外包括一个或多个传感器,诸如加速度计、血压传感器、心音传感器、血氧传感器和/或被配置为测量心脏和/或患者的一个或多个生理参数的其它传感器。在这种实施例中,机械感测模块208可以与引线212进行电通信并且可以接收从这种传感器中生成的信号。
尽管不是必需的,但在一些实施例中,MD 200可以是可植入医疗设备。在这种实施例中,MD 200的外壳220可以植入到,例如患者的经胸廓区域。外壳220通常可以包括许多已知材料中的任何一种,这些材料对于植入到人体内是安全的,并且可以在植入时将MD 200的各种组件密封以阻隔患者身体的液体和组织。在这种实施例中,引线212可以植入在患者内的一个或多个各种位置处,诸如在患者心脏内、邻近患者心脏、邻近患者脊柱或任何其它期望的位置。
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可以具有一个或多个引线,例如引线212,其被植入在患者心脏上或其内。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可以被配置为感测内在生成的心电信号,并且基于所感测的信号的分析来确定,例如一个或多个心律不齐。MD 200可以被配置为经由植入在心脏内的引线212来递送CRT、ATP治疗、心动过缓治疗和/或其它治疗类型。在一些实施例中,MD 200可以另外被配置为提供除颤/复律治疗。
在一些情况下,MD 200可以是可植入复律器-除颤器(ICD)。在这种实施例中,MD200可以包括植入在患者心脏内的一个或多个引线。MD 200还可以被配置为感测心电信号、基于感测到的心电信号来确定快速性心律失常的发生、并且响应于确定快速性心律失常的发生来递送除颤和/或复律治疗(例如通过将除颤和/或复律脉冲递送到患者的心脏)。在其它实施例中,MD 200可以是皮下可植入复律器-除颤器(SICD)。在MD 200是SICD的实施例中,引线212中的一个可以是皮下植入式引线。在MD 200是SICD的至少一些实施例中,MD200可以仅包括皮下植入但在胸腔外部植入的单个引线,然而这不是必需的。
在一些实施例中,MD 200可以不是可植入医疗设备。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。在这种实施例中,MD 200可以能够感测表面电信号(例如,由心脏生成的心电信号或由植入在患者体内的设备生成的并通过身体传导到皮肤的电信号)。MD200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说明了医疗设备系统和医疗设备系统的多个医疗设备302、304、306和/或310可以通过其进行通信的通信路径的实施例。在所示的实施例中,医疗设备系统300可以包括LCP 302和304、外部医疗设备306以及其它传感器/设备310。外部设备306可以是设置在患者身体外部的设备,如先前关于MD 200所述。在至少一些示例中,外部设备306可以表示诸如设备编程器的外部支持设备,如将在下面更详细描述的。其它传感器/设备310可以是先前关于MD 200所述的设备(诸如ICP、ICD以及SICD)中的任何一个。其它传感器/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、血压传感器等。在一些情况下,其它传感器/设备310可以包括可以用于对系统300的一个或多个设备进行编程的外部编程器设备。
系统300的各种设备可以经由通信路径308进行通信。例如,LCP 302和/或304可以感测内在心电信号,并且可以经由通信路径308将这些信号传送到系统300的一个或多个其它设备302/304、306以及310。在一个实施例中,设备302/304中的一个或多个可以接收这种信号,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,设备或设备302/304可以将这种确定传送到系统300的一个或多个其它设备306和310。在一些情况下,系统300的设备302/304、306以及310中的一个或多个可以基于所传送的心律失常的确定而采取行动,诸如通过将适当的电刺激递送到患者的心脏。系统300的设备302/304、306以及310中的一个或多个可以另外经由通信路径308传送命令或响应消息。命令消息可以致使接收设备采取特定行动,而响应消息可以包括所请求的信息或确认接收设备确实收到了所传送的消息或数据。
预期的是,系统300的各种设备可以使用RF信号、电感耦合、光学信号、声学信号或适于通信的任何其它信号经由路径308进行通信。另外,在至少一些实施例中,系统300的各种设备可以使用多个信号类型经由路径308进行通信。例如,其它传感器/设备310可以使用第一信号类型(例如RF通信)与外部设备306通信,但使用第二信号类型(例如传导通信)与LCP 302/304通信。此外,在一些实施例中,设备之间的通信可能受到限制。例如,如上所述,在一些实施例中,LCP 302/304可以仅通过其它传感器/设备310与外部设备306通信,其中LCP 302/304将信号发送到其它传感器/设备310,并且其它传感器/设备310将接收到的信号中继给外部设备306。
在一些情况下,系统300的各种设备可以使用传导通信信号经由路径308进行通信。因此,系统300的设备可以具有允许这种传导通信的组件。例如,系统300的设备可以被配置为经由传递设备的一个或多个电极将传导通信信号(例如,用电流和/或电压脉冲(本文中被称为电通信脉冲)不时打断的电压和/或电流波形)传递到患者体内并且可以经由接收设备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传递设备的一个或多个电极“传导”到系统300中的接收设备的电极。在这种实施例中,所递送的传导通信信号可以不同于起搏脉冲、除颤和/或复律脉冲或其它电刺激治疗信号。例如,系统300的设备可以以亚阈值的振幅/脉冲宽度来递送电通信脉冲。也就是说,通信脉冲具有被设计为不捕获心脏的振幅/脉冲宽度。在一些情况下,所递送的电通信脉冲的振幅/脉冲宽度可以高于心脏的捕获阈值,但可以在心脏的不应期内被递送和/或可以被并入或调制到起搏脉冲,如果需要。
此外,不同于正常的电刺激治疗脉冲,电通信脉冲可以以将信息传达给接收设备的特定序列来递送。例如,所递送的电通信脉冲可以以任何合适的方式被调制以编码所传送的信息。在一些情况下,通信脉冲可以是脉冲宽度调制和/或振幅调制。可替选地或另外,脉冲之间的时间可以被调制以编码所期望的信息。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、三相电压脉冲、三相电流脉冲、四相电压脉冲、四相电流脉冲、十六相电压脉冲、十六相电流脉冲或如所期望的任何其它合适的电脉冲,如本文进一步详述。
图4描绘了可以被配置为一起操作的说明性医疗设备系统400。例如,系统400可以包括植入在患者内的并被配置为感测生理信号、确定心脏心律失常的发生以及递送电刺激以治疗检测到的心脏心律失常的多个设备。在一些实施例中,系统400的设备可以被配置为确定系统400的一个或多个设备的移动的发生。在图4中,示出了LCP 402被固定到心脏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可以是皮下可植入复律器-除颤器(SICD)的部分,并且一个或多个电极408a-408c可以皮下定位邻近心脏。LCP 402可以诸如经由通信路径308与SICD进行通信。图4中所描绘的LCP 402、脉冲发生器406、引线412以及电极408a-c的位置仅是说明性的。在系统400的其它实施例中,根据需要,LCP402可以定位在心脏的左心室、右心房或左心房中。在其它实施例中,LCP 402可以邻近心脏410或甚至远离心脏410来外部植入。
医疗设备系统400还可以包括外部支持设备420。外部支持设备420可以用于使用本文所述通信技术中的一个或多个来执行功能,诸如设备识别、设备编程和/或在设备之间的实时数据和/或所存储的数据的传递,或涉及与系统400的一个或多个设备通信的其它功能。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来执行,并且脉冲发生器406和LCP 402之间的通信可以经由传导通信模式来执行。在一些实施例中,LCP 402和外部支持设备420之间的通信通过发送通过脉冲发生器406的通信信息来实现。然而,在其它实施例中,LCP 402和外部支持设备420之间的通信可以经由通信模块。
图4仅示出了可以被配置为根据本文所公开的技术进行操作的医疗设备系统的一个示例实施例。其它示例医疗设备系统可以包括另外的或不同的医疗设备和/或配置。例如,适于根据本文所公开的技术进行操作的其它医疗设备系统可以包括植入在心脏内的附加LCP。另一示例医疗设备系统可以包括具有或不具有其它设备(诸如脉冲发生器406)的多个LCP,其中至少一个LCP能够递送除颤治疗。又一示例可以包括与静脉起搏器一起并且与植入式SICD一起或不与植入式SICD一起植入的一个或多个LCP。在另外的其它实施例中,医疗设备、引线和/或电极的配置或放置可以不同于图4中所描绘的那些。因此,应该认识到,与图4中所描绘的系统400不同的许多其它医疗设备系统可以根据本文所公开的技术进行操作。因而,图4所示的实施例不应以任何方式将其视为限制。
图5A-B、6A-6D、9A-B、10A-10B以及11A-11B描绘了可以根据本公开的技术使用的示例相位通信脉冲。通常,这些相位传导通信脉冲有意地不同于起搏脉冲或其它电刺激治疗信号。所述的相位传导通信脉冲可以具有为有意地亚阈值的振幅/脉冲宽度组合,以便不捕获诸如心脏的身体组织。图7-8描述了适于在设备之间使用图5A-B、6A-6D、9A-B、10A-10B以及11A-11B中所示的说明性相位传导通信脉冲来传达信息的说明性通信方案。
通常,本文所述的相位传导通信脉冲可以是电压脉冲或电流脉冲。在电压脉冲中,电压振幅被控制并且电流取决于电压振幅和传输媒介的电阻。在电流脉冲中,电流振幅被控制并且电压取决于电流振幅和传输媒介的电阻。在一些示例中,相位传导通信脉冲可以是电压脉冲和电流脉冲的组合(例如,一些相位包括电压脉冲,而其它相位包括电流脉冲)。预期的是,关于图1-4所述的设备中的任何一个可以包括生成这种相位传导通信脉冲的电路。
图5A-B描绘了相位传导通信脉冲(包括相位传导通信脉冲501、503)的第一示例。如图5A-B中所示,相位传导通信脉冲501、503可以每个都包括第一相位505a、505b和第二相位507a、507b。在这些实施例中,第一相位505a、505b中的每个可以具有第一极性,并且第二相位507a、507b中的每个可以具有第二极性,其中第一极性和第二极性相反。示例相位传导通信脉冲501被描绘为具有具有正极性的第一相位505a,而第二相位507a具有负极性,而相位传导通信脉冲503以相反的方式被描绘。
第一相位505a、505b可以具有振幅506a、506b和缩短的脉冲宽度502a、502b。第二相位507a、507b可以具有振幅508a、508b和非缩短的脉冲宽度504a、504b。在这些实施例中,第一相位505a、505b的脉冲宽度502a、502b可以被认为是“缩短的脉冲宽度”,这是因为它们的长度被示出为小于第二相位507a、507b的脉冲宽度504a、504b的长度。例如,第一相位505a、505b的缩短脉冲宽度502a、502b可以具有范围在第二相位507a、507b的未缩短脉冲宽度504a、504b的值的大约5%和大约80%之间的值。术语“大约”意味着指定值的±10%。
在一些实施例中,第二相位507a、507b的脉冲宽度504a、504b可以具有范围在大约1微秒和大约75微秒之间的值。在更具体的实施例中,脉冲宽度504a、504b可以具有范围在大约1微秒和大约30微秒之间的值,或者可以是大约5微秒、大约10微秒、大约15微秒、大约20微秒、大约25微秒、大约30微秒、约35微秒、约40微秒或任何其它合适的值。对于电压脉冲,脉冲宽度是电压两次穿过电压脉冲振幅的50%之间的时间间隔。对于电流脉冲,脉冲宽度是电流两次穿过电流脉冲振幅的50%之间的时间间隔。
缩短的脉冲宽度502a、502b可以具有范围在脉冲宽度504a、504b的值的大约5%和大约80%之间的值。在更具体的实施例中,缩短的脉冲宽度502a、502b可以具有范围在脉冲宽度504a、504b的值的大约10%和大约50%之间的值,或者可以是脉冲宽度504a、504b的值的大约10%、大约20%、大约25%、大约30%、大约40%、大约50%、或者任何其它适当的百分比。
在一些情况下,脉冲宽度504a和504b(或缩短的脉冲宽度502a和502b)它们本身可能不具有完全相同的值。例如,脉冲宽度504a、504b(或缩短的脉冲宽度502a、502b)的值可以在连续递送的相位传导通信脉冲之间变化。在一些情况下,连续递送的相位传导通信脉冲之间不同的值可能变化小于大约10%。
在一些情况下,振幅506a、506b、508a以及508b全部都可以等于或大约等于具有与振幅506a、506b相反的极性(例如相对于中性或接地的正振幅或负振幅)的振幅508a、508b。通常,振幅506a、506b、508a以及508b可以是任何合适的值,但是在一些特定实施例中,振幅506a、506b、508a以及508b可以具有范围在大约1伏和大约15伏之间的值。在其它实施例中,振幅506a、506b、508a以及508b可以具有范围在大约2伏和大约7伏之间,或者大约1伏和大约4伏之间的值,或者等于大约1伏、大约2伏、大约3伏、大约4伏、大约5伏、大约6伏、大约7伏、或任何其它合适的值。关于相位传导通信脉冲所述的特定振幅值可以表示峰值振幅或均方根(RMS)振幅。
在一些情况下,振幅506a、506b可以相应地不等于振幅508a、508b,如果没有极性的差异。例如,在至少一些实施例中,振幅506a、506b可以相应地具有在振幅508a、508b的值的大约75%和大约99%之间的值。在另外的其它实施例中,振幅508a、508b可以具有较小的值。在另外的其它附加或可替选的实施例中,振幅506a、506b、508a和/或508b可以在连续递送的相位传导通信脉冲之间变化。例如,振幅506a、506b、508a以及508b的值可以在连续递送的相位传导通信脉冲之间变化小于大约10%。
可替选地,或除了上面描述的之外,预期的是缩短相位505a、505b的振幅505a、505b可以与未缩短相位507a、507b的振幅508a、508b不同,以便帮助控制可兴奋组织上的电荷累积并减少未缩短相位507a、507b将刺激组织的可能性。在一个特定示例中,参考图5A,脉冲宽度502a可以等于或大约等于脉冲宽度504a,并且振幅506a的绝对值可以小于(例如,缩短)振幅508a的绝对值。在一些情况下,缩短的相位505a、505b和未缩短的相位507a、507b的脉冲宽度和振幅可以被设置为帮助控制可兴奋组织上的电荷累积,并因此降低未缩短相位507a、507b将刺激组织的可能性。
尽管图5A-B描绘了具有具有通常矩形形态的第一相位505a、505b和第二相位507a、505b的双相传导通信脉冲501、503,但应当理解的是,本公开的技术不限于第一相位505a、505b和第二相位507a、507b的这些特定形态。图6A-6D描绘了具有不同相位形态的其它说明性脉冲。图6A描绘了具有锯齿形相位的双相传导通信脉冲512。图6B描绘了具有指数式相位的双相传导通信脉冲513。图6C描绘了具有梯形相位的双相传导通信脉冲514。图6D描绘了具有阶梯式相位的双相传导通信脉冲515。预期的是可以使用与这些基本类似的双相传导通信脉冲。就此而言,如果第一脉冲相位与第二脉冲相位之间的面积小于第二脉冲相位之下的面积的10%,则认为第一脉冲相位与第二脉冲相位基本类似,其中使第一脉冲相位的振幅和持续时间标准化为第二脉冲相位。应该理解的是,这些仅仅是示例脉冲形状。预期的是可以使用任何合适的脉冲形状。通常,缩短的前导脉冲可以使组织不适合通过一个或多个连续脉冲进行激励(例如捕获)。在一些情况下,拖尾的缩短脉冲(例如参见图9A-9B、图10A-10B、图11A-11B)可以用于电荷平衡或进一步的激励抑制。预期的是,只要前导脉冲以抑制激励(例如超极化)的方式向组织施加电荷,这种脉冲可以具有电压或电流对于时间的任何合适形式。
尽管图6A-D描绘了具有与图5A-B的相位形态不同的相位形态的相位传导通信脉冲,但图6A-D的每个相位传导通信脉冲的两个单独的相位可具有与关于第一相位505a、505b和第二相位507a、507b所述的值类似的值。显著地,在图6A-D中,在第二相位之前示出第一相位,其中第一相位的持续时间相对于第二相位被缩短。而且,虽然图6A-D的每个相位传导通信脉冲512-515都仅示为具有单个极性定向,但应当理解的是,如果需要,相位传导通信脉冲512-515可以被实现具有相反的极性定向。此外,预期的是,在短脉冲持续时间(例如,小于60微秒或更短)内,可以首先提供较长的脉冲,随后是较短的脉冲以在发生组织激活之前中和组织上的电荷。
图7和图8描绘了不同的示例通信方案,其可以通过诸如系统400的系统的设备与关于图5A-6D和在本公开的其它地方所述的相位传导通信脉冲一起使用。为了便于描述,仅示出了矩形相位传导通信脉冲,但应该理解的是,所公开的技术独立于相位传导通信脉冲形态。
图7示出了四个示例相位传导通信脉冲530a-d的曲线图。相位传导通信脉冲530a-d分别由三个不同的时期532、534以及536分开。在所示的示例中,最后的时期不将一个通信脉冲530d与另一通信电压脉冲分开。相反,时期538仅仅是从通信脉冲530d延伸的阈值时间长度,而没有在阈值时间长度结束之前出现随后的通信电压530。这可以发信号通知帧结束(EOF)。
在一些情况下,使用相位传导通信脉冲和本文所述的技术的系统的设备可以基于相位传导通信脉冲530a-d之间的时间长度来识别通信符号。例如,如果两个连续相位传导通信脉冲之间的时间落入第一时间范围内,那么第一符号可由接收器识别。如果两个相位传导通信脉冲之间的时间落入第二时间范围内,那么第二符号可由接收器识别。如果两个相位传导通信脉冲之间的时间落入第三时间范围内,那么第三个符号可由接收器识别,等等。在一个示例中,当两个相位传导通信脉冲之间的时间落入在800-1100微秒的范围内时识别同步符号,当两个相位传导通信脉冲之间的时间落入在550-700微秒的范围内时识别“1”符号,并且当两个相位传导通信脉冲之间的时间落入在350-450微秒的范围内时识别“0”符号。在一些情况下,“0”和“1”符号分别对应于“0”和“1”位,这是因为系统的设备可以在基本的两个数字系统中操作。这些只是示例。预期的是,通信协议中可以包括任何数量的不同符号,其中不同的符号被分配给不同的时间或时间范围。在一些情况下,如果在阈值时间量(例如时期538)内相位传导通信脉冲随后不是另一相位传导通信脉冲,则可以识别帧结束(EOF)符号。阈值时间量(例如,时期538)可以是,例如1250微秒或更多。
在一些情况下,可以使用内部时钟来跟踪相位传导通信脉冲之间的时间。预期的是,发送设备可以包括以时钟频率振荡的内部时钟。同样地,接收设备可以包括以相同(或不同)时钟频率振荡的内部时钟。当这样提供时,要传送的每个符号可以被分配相位传导通信脉冲之间的不同数量的时钟周期。例如,同步符号可以被分配24个时钟周期,其对于25.6kHz的时钟频率将对应于大约938微秒的相位传导通信脉冲之间的延迟。可以提供范围以帮助补偿噪声、温度变化、电压变化、时钟漂移等。该范围可以是,例如+/-10%,或者在上面给定的示例中,可以是从大约844微秒到大约1032微秒。“1”符号可以被分配给16个时钟周期,其对于25.6kHz的时钟频率将对应于大约625微秒的相位传导通信脉冲之间的延迟。可以围绕该图提供范围,以帮助补偿噪声、温度变化、电压变化、时钟漂移等。该范围可以是例如+/-10%,或者在上面给定的示例中可以是大约563微秒到大约688微秒。同样地,“0”符号可以被分配给10个时钟周期,其对于25.6k Hz的时钟频率将对应于大约391微秒的相位传导通信脉冲之间的延迟。可以围绕该图提供范围,以帮助补偿噪声、温度变化、电压变化、时钟漂移等。
为了传递期望的符号,发送设备可以提供第一相位传导通信脉冲,然后对与期望的符号相对应的时钟周期的数量进行计数(例如,对于“1”符号的16个时钟周期),然后提供相位传导通讯脉冲。当接收设备接收到第一相位传导通信脉冲时,接收设备可以开始对内部时钟周期进行计数。当接收到第二相位传导通信脉冲时,接收设备可以停止对时钟周期进行计数。接收设备然后可以将所计数的内部时钟周期的数量与分配给每个符号的时钟周期的数量进行比较。当找到匹配时,期望的符号由接收设备识别。
在一些情况下,发送设备和/或接收设备中的内部时钟的精确度可能随时间而降低。由于这种退化,系统的设备可能开始相对于绝对时间长度不同地确定时间长度,并且如果设备的时钟相对于彼此不同地降低,则可能相对于彼此不同地确定时间长度。因此,在时期532、534、536以及538是时间范围的示例中,系统的设备即使在一定程度的时钟退化之后仍然可以正确地解释符号。
在一些情况下,系统的设备可以被配置为在周期性或其它基础上重新配置它们的内部时钟。例如,第一设备可以广播开始校准信号、结束校准信号以及由广播设备确定的两个信号之间的时间长度。每个其它设备然后可以校准它们的内部时钟,使得两个校准信号之间的时期等于由广播设备发送的时间长度。这种重新配置可以有助于确保设备的时钟相对于系统的其它设备的时钟不漂移太远,使得设备在功能上不起作用。
无论时期532、534、536以及538的准确长度是多少,在一些示例中,时期532可以比时期534和536中的任一个更长。在这种示例中,该布置可以防止一个或多个符号从一个设备到另一设备或将噪声解释为一个或多个符号的通信的设备的意外传输。例如,系统的设备可以在传递一个或多个其它符号之前传递相位传导通信脉冲以传送同步符号,并且接收设备可以忽略在接收同步符号之前接收到的任何其它符号。在一些情况下,接收设备可以接收第一真实相位传导通信脉冲,不过在比时期532更短的时间长度之后接收噪声。如果噪声在形态上与相位传导通信脉冲类似,则接收设备可以将噪声解释为相位传导通信脉冲。然而,由于噪声在比时期532更短的时间长度之后发生,因此即使噪声发生在指示“0”符号或“1”符号的时间长度处,接收设备也将忽略这些符号,这是因为接收设备还没有接收到同步符号。以这种方式,系统的设备可以抑制不正确传递或错误解释的符号。
在一些情况下,在接收到每个相位传导通信脉冲之后,接收设备立即应用消隐期。在消隐期间,接收设备可以忽略任何接收到的通信信号。这可以帮助进一步减少在来自被解释为有效的相位传导通信脉冲的相位传导通信脉冲之后立即出现的噪声。消隐期可以是时期532的长度的四分之一至四分之三之间的任何时间,或者任何其它合适的时间长度。在一个示例中,消隐期可以是,例如大约250微秒。在一些情况下,发送设备可以在传输相位传导通信脉冲期间和/或其之后应用类似的消隐期。这种消隐期可以帮助防止发送设备的电路感测由发送设备生成的相位传导通信脉冲,该发送设备的电路感测来自其它设备的相位传导通信脉冲。
在图7中,系统的一个或多个接收设备可以识别通信脉冲530a和530b之间的经过时间532,并将该经过时间532解释为,例如同步符号。同样地,系统的一个或多个接收设备可以识别通信脉冲530b和530c之间的经过时间534,并将该经过时间534解释为,例如“1”符号。此外,系统的一个或多个接收设备可以识别通信脉冲530c和530d之间的经过时间536,并将该经过时间536解释为,例如“0”符号。在一些情况下,系统的一个或多个接收设备可以检测通信脉冲530d没有紧随阈值时间量538内的另一相位传导通信脉冲,并且可以将其解释为帧结束(EOF)符号。该特定示例仅仅是说明性的,并且预期的是,根据应用可以使用不同的符号、不同的时间延迟和不同的序列。
在一些示例中,系统的设备连续地(尽管可能被消隐期不时打断)监听相位传导通信脉冲。也就是说,在将相位传导通信脉冲发送到其它设备之前,系统的设备可能不发送唤醒信号或建立特定的通信连接。相反,系统的设备可以依靠同步脉冲作为发送设备正在发送消息到系统的其它设备的信号。在一些情况下,EOF符号可以是发送设备已经传送整个消息的信号。
在图7的示例中,时期532、534、536以及538被描绘为从每个通信脉冲530的前沿开始测量。然而,在其它示例中,时期532、534、536以及538可以从相位传导通信脉冲530的其它特征来测量。例如,系统的设备可以从相位传导通信脉冲530的后沿测量时期532、534、536以及538。在另外的其它示例中,系统的设备可以从相位传导通信脉冲530的拐点来测量时期532、534、536以及538。此外,系统的设备可以不从相位传导通信脉冲530的特征(例如前沿)开始测量时期,直到相位传导通信脉冲的振幅达到阈值水平为止。在一些情况下,系统的设备可以从相位传导通信脉冲530的零交叉点来测量时期532、534、536以及538。这些仅仅是一些示例。
在这些实施例中的一些实施例中,系统的设备可以确保在通信期间将相同总量的正幅度能量(例如,电压或电流)递送到患者的身体中作为负幅度能量。这可能有助于确保通信方案是电荷平衡的。尽管在一些实施例中,通信方案可能不是电荷平衡的。在发送或接收到的通信序列的相位传导通信脉冲的正幅度相位的曲线下面的总面积高于或低于发送或接收到的通信序列的相位传导通信脉冲的负幅度相位的总面积的10%以内的情况下,通信方案可以被认为基本上是电荷平衡的。
为了实现电荷平衡或基本电荷平衡的通信序列,发送设备可以使每个其它递送的相位传导通信脉冲的极性反转。例如,在上述示例中,相位传导通信脉冲530a可能看起来像相位传导通信脉冲501,并且通信脉冲530b可能看起来像相位传导通信脉冲503,例如,与相位传导通信脉冲501相比具有相反的极性。因此,在相位传导通信脉冲530a、530b相对于它们各自的相位中的每个具有相同的尺寸但翻转每个相位的极性的情况下,任何偶数串的相位传导通信脉冲将是电荷平衡的,并且任何奇数串的相位传导通信脉冲虽然不完全是电荷平衡的,但将基本上是电荷平衡的。可替选地,可以将最后的相位传导通信脉冲附加到任何奇数串的相位传导通信脉冲以创建偶数串。
图8描绘了可以利用本文所公开的相位传导通信脉冲来实现的另一说明性通信方案。替代改变连续相位传导通信脉冲之间的时间长度,图8的方案可以使用相位传导通信脉冲的极性的差异来对信息编码。
图8的示例描绘了脉冲540的序列。脉冲540的序列包括相位传导通信脉冲541-544。相位传导通信脉冲541和542具有第一极性,其中它们的第一相位具有正极性并且它们的第二相位具有负极性,而相位传导通信脉冲543和544具有第二极性,其中它们的第一相位具有负极性并且它们的第二相位具有正极性。在图8的示例中,第一极性或第二极性中的一个可以与“0”符号相关联,并且第一极性或第二极性中的另一个可以与“1”符号相关联。以这种方式,在使用图8的通信方案的设备根据二进制数系进行操作的情况下,设备可以使用相位传导通信脉冲的序列来传送信息,每个相位传导通信脉冲表示“0”或“1”。例如,在其中第一极性与“0”相关联并且第二极性与“1”相关联的图8的示例中,脉冲540的序列可以根据该通信方案来读取“0011”。
如图7的示例,对于发送的通信以进行电荷平衡或基本电荷平衡是有益的。然而,在图8的示例中,由于相位传导通信脉冲的极性表示信息,所以发送设备可能不能够使用关于图7描述的电荷平衡方案。相反,发送设备可以确定有多少个被所述设备发送的更多的具有所述极性中的一个极性的相位传导通信脉冲(与具有其它极性的相位传导通信脉冲相比)。例如,如果发送设备发送包括具有第一极性的四个相位传导通信脉冲和具有第二极性的两个相位传导通信脉冲的相位传导通信脉冲的序列,则设备可以确定该设备发送比具有第二极性的相位传导通信脉冲更多的具有第一极性的两个相位传导通信脉冲。然后发送设备可以递送包括具有第二极性的两个相位传导通信脉冲的脉冲序列。接收设备可能知道忽略从发送设备递送的每个其它脉冲序列作为电荷平衡序列。在一些实施例中,如果具有第一极性和第二极性(或具有第二极性和第一极性)的所递送脉冲的数量之间的差值低于阈值脉冲数量,则发送设备可能不发送任何电荷平衡脉冲序列。在这些实施例中,发送设备可以确定所传送的脉冲序列基本上是电荷平衡的,使得不需要电荷平衡脉冲序列。
图9A-B描绘了可以根据本公开所使用的另外其它说明性相位传导通信脉冲,相位传导通信脉冲551、553。通常,除了相位传导通信脉冲551、553包括三相而不是两相之外,相位传导通信脉冲551、553还可以类似于相位传导通信脉冲501、503。
从图9A-B中可以看出,相位传导通信脉冲551、553包括第一相位557a、557b;第二相位558a、558b以及第三相位559a、559b。第一相位557a、557b具有缩短的脉冲宽度552a、552b,而第二相位558a、558b和第三相位559a、559b具有未缩短的脉冲宽度554a、554b和556a、556b。如在图5A-B的实施例中,缩短的脉冲宽度552a、552b可以具有表示未缩短的脉冲宽度554a、554b和556a、556b的值的一部分的值。通常,关于相位传导通信脉冲501、503的缩短的脉冲宽度502a、502b和脉冲宽度504a、504b描述的值和比例可以同样地应用于缩短的脉冲宽度552a、552b和未缩短的脉冲宽度554a、554b和556a、556b。然而,在至少一些实施例中,脉冲宽度554a和556a和/或脉冲宽度554b和556b可能不相等。在一些情况下,该差值可以在大约1%和大约80%之间、在大约1%和大约50%之间、大约1%和大约30%之间、大约1%和大约10%之间。在一些情况下,脉冲宽度556a可以比脉冲宽度554a小大约等于缩短的脉冲宽度552a的量,并且脉冲宽度556b可以比脉冲宽度554b小大约等于缩短的脉冲宽度552b的量。
此外,相位传导通信脉冲551的相位557a和559a可以具有相同的振幅,振幅560a,而相位558a具有振幅555a。在一些实施例中,振幅560a和555a可以相等但幅度相反(例如,关于中性或接地的相反极性)。然而,在其它实施例中,振幅560a和555a可以不同,有时小于10%。在一些情况下,相位557a和559a可以具有相同或不同的振幅,但是二者仍然具有正幅度振幅(例如相同的极性)。在一些情况下,相位557a和559a的振幅可能相差小于10%。
在图5A-6B和图9A-B的每个实施例中,每个所公开的相位传导通信脉冲不一定是电荷平衡的。也就是说,每个相位传导通信脉冲可以不包括在具有正极性的相位传导通信脉冲的那些部分(不一定等于具有负极性的相位传导通信脉冲的那些部分)下面的区域。在一些实施例中,采用固有电荷平衡的相位传导通信脉冲可能是有益的,从而不需要通过对所递送的不同极性相位传导通信脉冲的数量之间的差值进行计数,或通过翻转每个连续递送的相位传导通信脉冲的极性来电荷平衡。
图10A-B描绘了显示为电荷平衡的四相相位传导通信脉冲。图10A-B分别描绘了相位传导通信脉冲561、563。相位传导通信脉冲561、563中的每个具有第一相位571a、571b;第二相位573a、573b;第三相位575a、575b以及第四相位577a、577b。第一相位571a、571b;第二相位573a、573b;第三相位575a、575b以及第四相位577a、577b中的每个具有对应的振幅和脉冲宽度。在所示的示例中,第一相位571a、571b和第四相位577a、577b具有缩短的脉冲宽度562a、562b和568a、568b,而第二相位573a、573b和第三相位575a、575b具有未缩短的脉冲宽度564a、564b,和566a、566b。通常,脉冲宽度564a、564b和566a、566b可以具有与关于本文描述的其它相位传导通信脉冲所述的值类似的值。此外,缩短的脉冲宽度562a、562b和568a、568b也可以具有与本文关于其它相位传导通信脉冲所述的那些值类似的值,或与脉冲宽度564a、564b和566a、566b成比例。此外,振幅565a、565b和567a、567b可以具有与关于先前描述的相位传导通信脉冲所述的那些振幅类似的值。
在缩短的脉冲宽度562a、562b和568a、568b彼此相等并且脉冲宽度564a、564b和566a、566b彼此相等的情况下,相位传导通信脉冲561、563将是电荷平衡的,这是因为第一相位571和第四相位577下的面积将等于第二相位573和第三相位575下的面积。然而,在其它实施例中,相位传导通信脉冲561、563的不同相位之间可能存在变化。在这些实施例中,在第一相位571和第四相位577下的面积与第二相位573和第四相位577下的面积之间存在小于10%的差值的情况下,相位传导通信脉冲561、563仍然可以被认为基本上是电荷平衡的。随着时间的推移,这些小的差异可能不会不利地影响植入了使用相位传导通信脉冲561、563的设备的患者。
在图11A-B中描绘了另外的说明性电荷平衡的相位传导通信脉冲。相位传导通信脉冲581、583是六相传导通信脉冲。相位传导通信脉冲581、583中的每个包括第一相位591、第二相位592、第三相位593、第四相位594、第五相位595以及第六相位596。如图所示,这些相位591-596中的每个都包括脉冲宽度582、584、586、588、590以及597。此外,还如图所示,相位591-596中的每个都具有振幅585或587。
在至少一些实施例中,脉冲宽度582、584、590以及597可以是缩短一个度或另一个度的脉冲宽度。例如,缩短的脉冲宽度584和590可以具有与关于缩短的脉冲宽度502a、502b所述的那些值相似的值和/或比例。缩短的脉冲宽度582和597可以具有不同的值或比例。例如,缩短的脉冲宽度584和590可以具有范围在脉冲宽度586和/或588的值的大约5%和大约80%之间的值。在更具体的实施例中,缩短的脉冲宽度582和597可以具有范围在脉冲宽度586和/或597的值的大约10%和大约50%之间的值或者是脉冲宽度586和/或597的值的大约10%、大约20%、大约25%、大约30%、大约40%、大约50%或任何其它合适的百分比的值。另一方面,缩短的脉冲宽度582和/或597可以具有范围在脉冲宽度586和/或597的值的大约1%和大约25%之间的值。
以类似于相位传导通信脉冲561、563的方式,当具有第一极性的相位591-593与具有第二相反极性的对应相位594-596对称时,相位传导通信脉冲581、583可以被电荷平衡。然而,即使在具有第一极性的相位与具有第二极性的相位不完全对称的实施例中,如果具有第一极性的相位的总面积是在具有第二极性的相位的总面积的大约10%之内,则相位传导通信脉冲581、583仍然可以被认为基本上是电荷平衡的。
可以基于对犬执行的研究来选择不同的所公开的相位传导通信脉冲的脉冲宽度的特定值。图12示出了对犬研究收集的数据的曲线图600,其示出了各种不同通信脉冲形态(包括单相、双相以及四相)的心脏捕获阈值对于脉冲宽度持续时间。期望不要利用通信脉冲来捕捉犬的心脏。因而,期望更高的捕获阈值。
曲线图600描绘了在脉冲宽度(x轴)对于脉冲致使心脏组织的刺激(即捕获)所处的振幅的双对数坐标图上的线601、603、605、607、609以及611。线601表示具有第一极性(阴极极性)的单相脉冲的结果,而线603表示具有与第一极性相反的第二极性(阳极极性)的单相脉冲的结果。线605和607描绘了具有相反极性的双相脉冲的结果,并且线609和线611描绘了具有相反极性的四相脉冲的结果。
曲线图600的x轴的脉冲宽度持续时间值表示未缩短的脉冲宽度的值。例如,关于四相脉冲,脉冲宽度持续时间值对应于四相脉冲561、563的脉冲宽度564、566的值。对于单相脉冲,脉冲宽度持续时间等于整个脉冲的总脉冲宽度。对于双相脉冲,脉冲宽度持续时间值对应于总脉冲宽度的一半,这是因为研究中使用的双相脉冲具有两个相等的持续时间相位,这与本公开的具有初始相位宽度(缩短的脉冲宽度)的双相脉冲不同。对于四相脉冲,第一相位和第四相位具有相对于第二相位和第三相位的缩短的脉冲宽度。第二相位和第三相位具有基本相等的脉冲宽度,并且第一相位和第四相位具有第二相位和第三相位的脉冲宽度的大约一半的脉冲宽度。
如曲线图600中所示,在区域602中的相对较长的脉冲宽度处,不同的脉冲都以相对类似的振幅(例如,在大约500mV和大约1V之间)致使心脏组织的刺激,其中单相阴极脉冲具有不会致使模拟的最高振幅。在该区域中,脉冲宽度在大约250微秒到大约500微秒之间。
在区域604中开始,不同脉冲致使心脏刺激所处的振幅开始分离。例如,特别是在大约75微秒和大约50微秒的脉冲长度之间,在不同脉冲致使刺激的振幅处存在明显的分离。如所看到的,两个四相脉冲已经超过了明确具有最高振幅的其它脉冲,这些脉冲在大约60微秒的脉冲宽度处仍然没有被激励。
等到脉冲宽度下降到25微秒或20微秒和5微秒之间时,四相脉冲之前所必需的振幅之间的差异致使刺激,且其它脉冲致使刺激是显著的。例如,在6微秒处,四相脉冲要求大约40V以便致使心脏的刺激,而双相脉冲仅要求大约20V或22V。在该脉冲宽度范围内的单相脉冲只要求9-11V之间以被刺激。
在一些情况下,预期的是意味着捕获心脏的电刺激脉冲可以使用第一极性来递送,并且不意味着捕获心脏的通信脉冲可以使用第二相反极性来递送。例如,在图1所示的示例LCP 100中,脉冲发生器模块104可以使用电极114递送电刺激脉冲。在所示的示例中,电极114包括LCP 100的左端上的较小电极和朝着LCP 100右侧的环形表面电极。LCP 100的左端上的较小电极可以具有比朝着LCP 100右侧的较大环形表面电极小得多的表面面积。因此,当电脉冲在这两个电极之间递送时,LCP 100左端上的较小电极处的电流密度高于较大环形表面电极处的电流密度。因而,通常期望的是将较小的电极放置在心脏组织附近或与心脏组织接触以减少捕获心脏所需的能量。当这样提供时,可以递送电刺激脉冲的极性,使得较小的电极用作阴极,并且朝着LCP 100右侧的较大的环形表面电极用作阳极。
尽管期望在递送电刺激治疗时减少捕获心脏所需的能量(即降低捕获阈值),但通常期望在递送通信脉冲时增加捕获心脏所需的能量(即增加捕获阈值)。因而,并在一些情况下,可以递送通信脉冲的极性,使得LCP 100的左端上的较小电极用作阳极,并且朝着LCP100右侧的较大的环形表面电极用作阴极。可替选地或另外,通信脉冲的脉冲宽度持续时间可以小于电刺激脉冲的脉冲宽度持续时间。如图12所示,当施加阳极极性对于阴极极性的脉冲时,特别是对于小于大约60微秒的脉冲宽度持续时间的单相脉冲,捕获阈值之间可能存在显著差异。在一些情况下,可以使用具有大于60微秒的脉冲宽度持续时间的阴极极性来递送电刺激脉冲,并且可以使用具有小于60微秒的脉冲宽度持续时间的阳极极性来递送通信脉冲。这仅仅是一个示例。
相信所公开的具有缩短脉冲宽度的第一相位的双相、三相、四相以及其它多相脉冲的第一相位以第二更长的相位如何加载心脏的相反方式来预加载组织(例如心脏)。也就是说,根据第一相位的极性,第一相位可以将电荷吸引到心脏细胞或将电荷推离心脏细胞。该机制可以与脉冲的第二相位如何致使心脏细胞附近的电荷起作用直接相反。因此,该预加载可以允许较长的脉冲宽度持续时间(例如脉冲的随后相位中的较长脉冲宽度)或较高的振幅以用于通信脉冲,而不用担心意外致使心脏或其它组织的不需要的刺激。或者,当使用传导通信脉冲时,预加载可以增强系统操作的安全裕度,这是因为它增加了通信脉冲将致使刺激所处的振幅。在不致使不需要的组织刺激的情况下,允许使用相对较大的能量通信脉冲可以增强接收器接收通信脉冲的能力,并且增加通信脉冲关于它们的刺激振幅阈值的安全裕度。
如上所述,并且在一些情况下,图5A-5B、6A-6D、9A-9B、10A-10B以及11A-11B中的各种缩短相位和未缩短相位的脉冲宽度和振幅中的一个或两个可以被设置以帮助控制可兴奋组织上的电荷累积,并因此减少未缩短的相位将刺激组织的可能性。
本领域的技术人员将认识到,本公开可以以除了本文中所述和预期的特定实施例以外的各种形式来表明。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,其它实施例可以包括将所述功能分为比本文所述的更多模块的附加模块。此外,其它实施例可以将所述功能合并成更少的模块。
尽管可能已经关于少于所有实施例来描述了各种特征,但是本公开考虑了这些特征可以被包括在任何实施例上。此外,虽然本文描述的实施例可能已经省略了各种所述特征的一些组合,但是本公开考虑了包括每个所述特征的任何组合的实施例。因此,在不脱离所附权利要求中所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 (14)
1.一种用于植入在具有心脏的患者内的可植入医疗设备,包括:
外壳;
脉冲发生电路,其被至少部分地设置在所述外壳内;
多个电极,其电耦合到所述脉冲发生电路,所述多个电极暴露在所述外壳的外部;
控制器,其可操作地耦合到所述脉冲发生电路,所述控制器被配置为:
命令所述脉冲发生电路经由所述多个电极中的至少两个来递送亚阈值相位传导通信脉冲;
其中所述亚阈值相位传导通信脉冲包括具有第一极性的第一相位,接着是具有相反的第二极性的第二相位;
所述第二相位具有小于60微秒的持续时间;
所述第一相位具有所述第二相位的持续时间的5%和80%之间的持续时间;并且
其中包括所述第一相位和所述第二相位两者的亚阈值相位传导通信脉冲是亚阈值的并且不刺激患者的心脏。
2.根据权利要求1所述的可植入医疗设备,其中所述第一相位具有第一相位振幅,其中所述第一相位振幅的绝对值在1至15伏之间。
3.根据权利要求1所述的可植入医疗设备,其中所述第二相位具有第二相位振幅,其中所述第二相位振幅的绝对值在1至15伏之间。
4.根据权利要求1所述的可植入医疗设备,其中所述第一相位具有在2至7伏之间的绝对值的第一相位振幅,并且所述第二相位具有在2至7伏之间的绝对值的第二相位振幅。
5.根据权利要求4所述的可植入医疗设备,其中所述第一相位具有在1至4伏之间的绝对值的第一相位振幅,并且所述第二相位具有在1至4伏之间的绝对值的第二相位振幅。
6.根据权利要求5所述的可植入医疗设备,其中所述第二相位具有小于30微秒的持续时间。
7.根据权利要求5所述的可植入医疗设备,其中所述第二相位具有小于20微秒的持续时间。
8.根据权利要求1所述的可植入医疗设备,其中所述第一相位具有所述第二相位的持续时间的40%至60%之间的持续时间。
9.根据权利要求1所述的可植入医疗设备,其中所述第一相位和所述第二相位每个都基本上是矩形脉冲。
10.根据权利要求1所述的可植入医疗设备,其中所述第一相位和所述第二相位各自基本上是矩形脉冲、锯齿形脉冲、指数式脉冲、梯形脉冲或阶梯式脉冲。
11.根据权利要求1所述的可植入医疗设备,其中所述亚阈值相位传导通信脉冲包括第三相位。
12.根据权利要求11所述的可植入医疗设备,其中所述第三相位具有所述第一极性。
13.根据权利要求1所述的可植入医疗设备,其中所述亚阈值相位传导通信脉冲基本上是电荷平衡的。
14.根据权利要求1所述的可植入医疗设备,其中所述亚阈值相位传导通信脉冲具有四个或更多个相位。
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