CN106535987A - 通过用于心房同步心室起搏的心室无引线起搏设备进行心房收缩检测 - Google Patents
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Abstract
一种无引线起搏设备(LPD)包括运动传感器,所述运动传感器被配置成用于根据心脏运动生成运动信号。所述LPD被配置成用于:在心室激动之后开始心房收缩检测延迟期的心房收缩检测窗口内分析所述运动信号,并且基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测心脏的心房收缩。如果所述LPD在所述心房收缩之后未检测到心室去极化,例如在检测到所述心房收缩时开始的房室(AV)间期内,则所述LPD递送心室起搏脉冲。
Description
本申请要求2014年7月25日提交的美国临时申请号62/028,957的权益和2014年12月22日提交的美国实用新型申请号14/579,105的权益,所述申请的全部内容通过引用结合在此。
技术领域
本公开涉及心脏起搏,并且更具体地涉及使用无引线起搏设备进行心脏起搏。
背景技术
可植入起搏器可以向患者的心脏递送起搏脉冲并且监测所述患者的心脏状况。在一些示例中,所述可植入起搏器包括脉冲发生器以及一根或多根电引线。所述脉冲发生器可以例如植入在患者胸部中的小口袋中。所述电引线可以耦合至脉冲发生器,所述脉冲发生器可以包含生成起搏脉冲和/或感测心脏电活动的电路。所述电引线可以从所述脉冲发生器延伸至目标部位(例如,心房和/或心室),从而使得在电引线的远端处的电极被定位在目标部位处。所述脉冲发生器可以向所述目标部位提供电刺激和/或经由电极监测所述目标部位处的心脏电活动。
还提出了一种用于感测电活动和/或向心脏递送治疗电信号的无引线起搏设备。所述无引线起搏设备可以包括在其外壳上的一个或多个电极,所述一个或多个电极用于递送治疗电信号和/或感测心脏的固有去极化。所述无引线起搏设备可以定位在心脏之内或之外,并且在一些示例中可以经由固定机构被锚定到心脏壁上。
发明内容
本公开描述了一种无引线起搏设备(下文中,“LPD”),所述无引线起搏设备被配置成植入患者心脏的心室,并被配置成用于基于检测到心房收缩递送心房同步心室起搏。更具体地,所述LPD包括被配置成用于根据心脏运动生成运动信号的运动传感器。所述运动传感器可以包括一个或多个加速度计,所述加速度计可以具有单个轴线、或多个轴线。所述LPD被配置成用于在心房收缩检测窗口内分析所述运动信号。所述心房收缩检测窗口开始于心房收缩检测延迟期完成时,所述心房收缩检测延迟期开始于检测到心室激动时。所述LPD被配置成用于基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测所述心脏的心房收缩。如果所述LPD在所述心房收缩之后未检测到心室去极化,例如在检测到所述心房收缩时开始的房室(AV)间期内,则所述LPD递送心室起搏脉冲。在一些示例中,所述LPD被配置成用于经由LPD的多个电极基于心房去极化检测使用电学AV间期递送心房同步心室起搏,并且如果LPD不能检测心脏去极化,则切换为基于心房收缩检测使用机械AV间期(可能比电学AV间期更短)递送心房同步心室起搏。
在一个示例中,一种无引线起搏设备被配置成用于提供心房同步心室起搏。所述无引线起搏设备包括:多个电极;运动传感器,所述运动传感器被配置成用于根据患者的心脏运动生成运动信号;刺激模块,所述刺激模块耦合至所述多个电极,其中,所述刺激模块被配置成用于生成起搏脉冲并且经由所述多个电极将所述起搏脉冲递送至所述心脏的心室;以及电感测模块,所述电感测模块耦合至所述多个电极,其中,所述电感测模块被配置成用于在经由所述多个电极所感测到的心脏电描记图(cardiac electrogram)内检测所述心室的去极化。所述无引线起搏设备进一步包括机械感测模块,所述机械感测模块耦合至所述运动传感器。所述机械感测模块被配置成用于:从所述运动传感器接收所述运动信号;识别所述心室的激动;并且在识别到所述心室的所述激动时,发起心房收缩检测延迟期。所述机械感测模块进一步被配置成用于:在完成所述心房收缩检测延迟期时开始的心房收缩检测窗口内分析所述运动信号;并且基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测所述心脏的心房收缩。所述无引线起搏设备进一步包括:处理模块,所述处理模块被配置成用于控制所述刺激模块生成起搏脉冲并响应于由所述机械感测模块检测到所述心房的收缩而经由所述多个电极将所述起搏脉冲递送至所述心室。所述无引线起搏设备进一步包括:壳体,所述壳体被配置成植入在所述心室内,其中,所述壳体封闭所述运动传感器、所述刺激模块、所述电感测模块、所述机械感测模块、和所述处理模块。
在另一示例中,一种用于通过植入在患者的心脏心室内的无引线起搏设备提供心房同步心室起搏的方法包括:识别所述心室的激动;在识别到所述心室的所述激动时,发起心房收缩检测延迟期;以及在完成所述心房收缩检测延迟期时开始的心房收缩检测窗口内分析所述运动信号。所述运动信号是由所述无引线起搏设备的运动传感器根据心脏运动生成的。所述方法进一步包括:基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测所述心脏的心房收;并且响应于检测到所述心房的所述收缩,向所述心室递送起搏脉冲。
在另一示例中,一种无引线起搏设备被配置成用于提供心房同步心室起搏。所述无引线起搏设备包括:用于根据患者的心脏运动生成运动信号的装置;用于识别所述心脏的心室的激动的装置;用于在识别到所述心室的所述激动时发起心房收缩检测延迟期的装置;以及用于在完成所述心房收缩检测延迟期时发起的心房收缩检测窗口内分析所述运动信号的装置。所述无引线起搏设备进一步包括:用于基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测所述心脏的心房收缩的装置;以及用于响应于检测到心房收缩向所述心室递送起搏脉冲的装置。
在另一示例中,一种计算机可读存储介质包括存储于其上的指令,当由被配置成用于提供心房同步心室起搏的无引线起搏设备的一个或多个可编程处理器执行时,所述指令使得所述一个或多个处理器:识别所述心室的激动;在识别到所述心室的所述激动时,发起心房收缩检测延迟期;并在完成所述心房收缩检测延迟期时开始的心房收缩检测窗口内分析运动信号。所述运动信号是由所述无引线起搏设备的运动传感器根据心脏运动生成的。所述指令进一步使得所述一个或多个处理器基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测心脏的心房收缩,并响应于检测到所述心房的收缩控制而将起搏脉冲递送至所述心室。
以下附图和说明阐述了一个或多个示例的细节。从本说明书和附图以及权利要求书中将清楚了解其他特征、目的以及优点。
附图说明
图1是展示了示例无引线起搏系统的概念图,所述示例无引线起搏系统包括被植入患者体内的示例无引线起搏设备,所述示例无引线起搏设备被配置成用于基于心房收缩检测递送心房同步心室起搏。
图2是进一步展示图1的示例无引线起搏设备的概念图。
图3是展示了另一示例无引线起搏系统的概念图,所述另一示例无引线起搏系统包括被植入患者体内的另一示例无引线起搏设备,所述另一示例无引线起搏设备被配置成用于基于心房收缩检测递送心房同步心室起搏。
图4是展示了被配置成用于基于心房收缩检测递送心房同步心室起搏的无引线起搏设备的示例配置的功能框图。
图5是展示了心脏电描记图和相应的运动信号的曲线图。
图6是展示了用于基于心房收缩检测递送心房同步心室起搏的示例技术的时序图。
图7是用于基于心房收缩检测递送心房同步心室起搏的示例技术的流程图,所述心房收缩检测可以由心室内植入的无引线起搏设备执行。
图8是展示了用于基于对动作信号的分析检测心房收缩的示例技术的流程图,所述分析可以由心室内植入的无引线起搏设备执行。
图9是展示了用于基于心房收缩检测验证心房同步心室起搏功效的示例技术的流程图,所述心房收缩检测可以由心室内植入的无引线起搏设备执行。
图10是展示了用于在心房同步心室起搏模式与异步起搏模式之间切换的示例技术的流程图,所述切换可以由心室内植入的无引线起搏设备执行。
图11是展示了用于在响应于心房去极化的心房同步心室起搏与响应于心房收缩的心房同步心室起搏之间切换的示例技术的流程图,所述切换可以由心室内植入的无引线起搏设备执行。
具体实施方式
通常,双腔室可植入起搏器被植入患者胸腔的袋内,并耦合至右心房引线和右心室引线。所述右心房引线从所述袋中的可植入起搏器延伸至患者心脏的右心房,并将一个或多个电极定位在右心房内。所述右心室引线从所述袋中的可植入起搏器延伸至患者心脏的右心室,并将一个或多个电极定位在右心室内。
这种双腔室可植入起搏器经由植入右心房的一个或多个电极或植入右心室的一个或多个电极感测对应的心脏电活动,例如对应的心脏电描记图。具体地,这种双腔室可植入起搏器经由右心房内植入的一个或多个电极检测固有心房去极化并经由右心室内植入的一个或多个电极检测固有心室去极化。所述可植入起搏器还可以分别经由右心房和右心室内的一个或多个电极向右心房和右心室递送起搏脉冲。由于感测心房电活动和心室电活动两者的能力,此类双腔室可植入起搏器可能能够提供心房同步心室起搏。对于伴随间歇性AV节传导的患者,可能更优选的是禁止心室起搏并允许在固有心房去极化或心房起搏之后的时间(称为AV间期)发生固有心室去极化。双腔室可植入起搏器内的这种心房同步起搏可以根据VDD或DDD编程模式,其已用于治疗具有各种程度AV阻滞的患者。
可植入式心脏引线以及起搏器被植入的袋可能与并发症有联系。为了避免此类并发症,无引线起搏设备尺寸被设定为整体植入所提出的心脏的一个腔室(例如,右心室)内。所提出的一些无引线起搏器包括多个电极,所述电极被附装在无引线起搏设备的壳体上或是其一部分。
所提出的一些无引线起搏设备能够经由所述多个电极感测它们被植入的心脏腔室的固有去极化并向其递送起搏脉冲。然而,由于它们未耦合至任何其他腔室内的电极,所提出的一些无引线起搏设备不能感测心脏的另一腔室的固有去极化并向其递送起搏脉冲。所以,当例如被植入右心室时,所提出的此类无引线起搏设备可能不能感测心房的固有心房去极化,并且会限制于根据异步心室起搏(例如,根据VVI或VVIR模式)递送心室起搏。
图1是展示了示例无引线起搏系统10A的概念图,所述示例无引线起搏系统包括被配置成用于基于心房收缩检测递送心房同步心室起搏的示例无引线起搏设备(LPD)12A。在图1的示例中,LPD 12A被植入患者14的心脏16的右心室18。更具体地,LPD 12A被固定或附装至右心室18的内壁,在图1的示例中接近右心室的顶点。在其他示例中,LPD 12A可以在另一位置固定至右心室18的内壁,例如右心室的心室内隔膜或自由壁上,或可以固定至心脏16的外部,即,心外膜地接近右心室18。在其他示例中,LPD可以固定在心脏16的左心室内、上、或附近。
LPD 12A包括多个电极,所述电极被附装在LPD 12A的壳体上或是其一部分。LPD12A经由电极感测与心脏16的去极化和复极化相关联的电信号,即心脏电描记图信号。LPD12A还经由电极向右心室18递送心脏起搏脉冲。
LPD 12A在心脏电描记图内检测右心室18的去极化。在一些示例中,LPD12A未被配置成用于在心脏电描记图信号内检测心房(例如,右心房20)或一般地心脏16的心房的固有去极化。在其他示例中,LPD 12A被配置成用于在心脏电描记图信号内检测心房去极化。在一些示例中,LDP 12A被配置成用于借助心脏电描记图信号来检测心房去极化,但有时可能不能可靠地检测心房去极化,例如由于心脏电描记图信号的质量,或经由置于右心室18内的电极所感测到的心脏电描记图信号内的心脏去极化的相对较小幅度。LPD 12A被配置成用于检测心房(例如心房20)或一般地心脏16的心房的机械收缩,例如作为感测右心房20的电学去极化的替代方案。以这种方式,LPD 12A可以被配置成用于向右心室18递送心房同步心室起搏,即使在未被配置成用于或不能检测心房去极化时。
如下文更加详细描述的,LPD 12A包括:运动传感器,所述运动传感器被配置成用于根据患者心脏运动生成运动信号。LPD 12A被配置成用于识别右心室18的激动事件,并在完成心房收缩检测延迟期时开始的心房收缩检测窗口内分析运动信号,所述心房收缩检测延迟期在检测到所述心室的所述激动时发起。所述心室的所述激动可以是心室的固有去极化或向心室递送起搏脉冲。在一些示例中,LPD 12A可以被配置成用于基于所述运动信号检测右心室18的收缩,并基于所检测到的心室收缩识别心室的激动。
LPD 12A被配置成用于基于在所述心房收缩检测窗口内对所述运动信号的所述分析来检测心房收缩。如果未检测到右心室18的后续固有去极化,例如在检测到心房收缩时开始的AV间期内,LPD 12A进一步被配置成用于向右心室18递送起搏脉冲。以这种方式,LPD12A被配置成用于基于心房收缩的检测向右心室18递送心房同步起搏。
在一些示例中,LPD 12A被配置成用于评估向右心室18递送心房同步起搏的功效。例如,LPD 12A可以在向右心室递送起搏脉冲之后基于运动信号检测产生的右心室18的收缩,并基于右心室收缩的检测判定起搏脉冲向右心室的递送是否有效。在一些示例中,LPD12A可以确定心室收缩的一个或多个度量,比如心室收缩的时机或幅度,并基于所述一个或多个度量调整心室起搏的递送。作为一个示例,LPD 12A可以基于所述一个或多个度量调整在检测到心房收缩时开始的AV间期。
除了心脏的运动之外,LPD 12A的运动传感器所生成的运动信号可以包括患者活动所导致的或患者所经历的(例如,驾驶车辆)患者14的更一般运动。患者14的这种运动会干扰LPD 12A检测心房收缩的能力。在一些示例中,LPD12A被配置成用于基于运动信号确定患者14的运动量,并响应于确定患者运动量超过阈值而从根据心房同步起搏模式递送心室起搏改变成根据异步起搏模式递送心室起搏。在一些示例中,LPD 12A另外或可替代地被配置成用于:响应于确定心率相对较高和/或不规律,从根据心房同步起搏模式递送心室起搏改变成根据异步起搏模式递送心室起搏,例如基于连续固有心室去极化之间的间隔与存储的阈值,比如大约100次每分钟(bpm)。在一些示例中,LPD 12A另外或可替代的被配置成用于:响应于确定在预定数量的心动周期内未检测到心室收缩,从根据心房同步起搏模式递送心室起搏改变成根据异步起搏模式递送心室起搏。根据异步心室起搏模式,例如VVI或VVIR,如果在检测到之前的固有心室去极化或递送了之前的固有心室起搏脉冲时开始的VV间期内未检测到固有心室去极化,LPD 12A递送心室起搏脉冲。
如图1中所展示的,无引线起搏系统10A还包括医疗设备编程器22,所述医疗设备编程器被配置成用于对LPD 12A进行编程并从LPD 12A检索数据。作为例子,编程器22可以是手持计算设备、台式计算设备、联网计算设备、或任何其他类型的计算设备。编程器22可以包括计算机可读存储介质,所述计算机可读存储介质具有使得编程器22的处理器提供属于本公开的编程器22的功能的指令。LPD 12A可以与编程器22无线地通信。例如,LPD 12A可以向编程器22传输数据并从编程器22接收数据。编程器22还可以对LPD 12A无线地编程和/或无线地充电。
使用编程器22从LPD 12A检索的数据可以包括:LPD 12A存储的指示心脏16的电学和机械活动的心脏电描记图和运动信号,以及指示与LPD 12A相关联的感测、诊断、和治疗事件(例如,心房和心室去极化、心房和心室收缩、以及脉冲递送的检测)的发生和时机的标记通道数据。使用编程器22传输至LPD 12A的数据可以包括例如使得LPD 12A如在此所述运行的LPD 12A的操作程序。作为示例,使用编程器22传输至LPD 12A的数据可以包括在此所描述的任何AV间期、心房收缩检测延迟期、和心房收缩检测窗口的长度,LPD12A用来基于心脏16、患者14、或LPD 12A的确定参数来确定此类值的任何阈值(比如用于检测心房和/或心室收缩或编程)。
图2是进一步展示LPD 12A的概念图。如图2中所展示的,LPD 12A包括外壳30、固定齿32A-32D(统称为“固定齿32”)、和电极34和36。外壳30被配置成允许LPD 12A被完全植入心脏16的腔室(比如右心室18),例如,具有允许这样的尺寸和形状因数。如图2中所展示的,在一些示例中,壳体30可以具有圆柱形(例如,药丸形)形状因数。壳体30可以被气密性密封从而防止液体进入壳体30内部。
固定齿32延伸自外壳30,并被配置成与心脏组织啮合从而将壳体30的位置基本上固定在心脏16的腔室内,例如在右心室18的顶点处或附近。固定齿32被配置成用于将壳体30锚定至心脏组织,从而使得在心脏收缩过程中LPD 12A与心脏组织一起移动。固定齿32可以由任何适当材料制造,比如形状记忆材料(例如,镍钛诺合金)。图2中所展示的固定齿32的数量和配置仅仅是一个示例,并且考虑了用于将LPD壳体锚定至心脏组织的其他固定齿数量和配置。另外,虽然LPD 12A包括被配置成用于将LPD 12A锚定至心脏腔室中的心脏组织的多个固定齿32,在其他示例中,LPD 12A可以使用其他类型的固定机构(比如但不限于倒钩、线圈等)固定至心脏组织。
LPD 12A被配置成用于感测心脏16的电学活动(即,心脏电描记图)并经由电极34和36向右心室18递送起搏脉冲。电极34和36可以机械的连接至壳体30,或者可以由壳体30的导电部分限定。在任一种情况下,电极彼此电学地隔离。电极34可以被称为尖端电极,并且固定齿32可以被配置成用于将LPD 12A锚定至心脏组织,从而使得电极34保持与心脏组织接触。电极36可以由壳体30的导电部分限定,并且在一些示例中可以定义容纳LPD 12A的电源(例如,电池)的电源套的至少一部分。在一些示例中,壳体30的一部分可以被绝缘材料覆盖或由绝缘材料形成,以将电极34和36彼此隔离和/或以为电极34和36之一或两者提供期望尺寸和形状。
外壳30容纳LPD 12A的电子部件,例如用于经由电极34和36感测心脏电活动的电感测模块,运动传感器,用于检测心脏收缩的机械感测模块,以及用于经由电极34和36递送起搏脉冲的电刺激模块。电子部件可以包括任何离散和/或集成电子电路部件,所述部件执行能够产生归属于在此所述的LPD功能的模拟电路和/或数字电路。另外,壳体30可以容纳存储器,所述存储器包括当被容纳在壳体30中的一个或多个处理器执行时使得LPD 12A执行属于在此的LPD 12A的各个功能的指令。在一些示例中,壳体30可以容纳通信模块,所述通信模块使LPD 12A能够与其他电子设备通信,比如医学设备编程器22。在一些示例中,壳体30可以容纳用于无线通信的天线。壳体30还可以容纳电源,比如电池。
图3是展示了另一示例无引线起搏系统10B的概念图,所述另一示例无引线起搏系统包括被配置成用于基于心房收缩检测递送心房同步心室起搏的另一示例LPD 12B。无引线起搏系统10B和LPD 12B可以与上文参照图1和图2所描述的无引线起搏系统10A和LPD12A基本上相同。然而,与LPD 12A不同,LPD 12B包括感测延伸部40,所述感测延伸部包括电极42。在一些示例中,感测延伸部40可以包括与电极42具有相同极性的一个或多个附加电极。虽然在图3中未加以展示,LPD 12B可以包括电极34,但可能不包括电极36,如上文参照LPD 12A和图2所描述的。
电极42经由感测延伸部40的电导体与LPD 12B的壳体内的电子装置(例如,电感测模块和刺激模块)连接。在一些示例中,感测延伸部40的电导体经由LPD 12B的壳体的导电部分与所述电子装置连接,所述导电部分可以对应于LPD 12A(图2)的电极36但可能基本上完全地绝缘(例如,完全地绝缘或几乎完全地绝缘)。使壳体的所述导电部分基本上完全地绝缘可以允许LPD 12B的电感测模块用感测延伸部40的电极42而不是壳体的导电部分感测心脏电活动。
另外,如图3中所示,感测延伸部40延伸离开LPD 12,这使电极42能够被定位成相对靠近右心房20。结果是,LPD 12B经由电极34(图2)和42感测的心脏电描记图与LPB 12A经由电极34和36(图2)感测的心脏电描记图相比可以包括更高幅度远场心房去极化信号。以这种方式,当LPD 12B被植入右心室18内时,感测延伸部40可以方便心房去极化的检测。在一些示例中,感测延伸部40的尺寸被确定为完全被植入右心室18内。在其他示例中,感测延伸部40的尺寸被确定为延伸至右心房20内。
LPD 12B被配置成用于在心脏电描记图信号内检测心房去极化。相应地,LPD 12B可以被配置成用于基于心房去极化的检测递送心房同步心室起搏。例如,如果在检测到右心房20的去极化之后的AV间期内未检测到右心室18的固有去极化,LPD 12B可以被配置成用于向右心室18递送起搏脉冲。
然而,尽管感测延伸部40,LPD 12B有时可能能够检测右心房20的去极化,例如由于心脏电描记图信号质量降低。心脏电描记图信号质量降低可以包括心脏电描记图信号的心房分量的幅度减小和/或噪声增加。心脏电描记图信号降低可能由例如感测延伸部40相对于右心房20的移动造成,所述移动可以由患者14的姿势或活动,或患者14、心脏16、和/或LPD 12B的其他状况引起。结果是,LPD 12B还被配置成用于检测心房收缩,并基于所述心房收缩递送心房同步心室起搏,如参照LPD 12A所描述的。
在一些示例中,LPD 12B被配置成用于确定在心动周期中未检测到心房去极化。例如,LPD 12B可以被配置成用于确定在连续的心室去极化之间未检测到心房去极化。在一些示例中,响应于确定在预定数量的心动周期内未检测到心房的去极化,LPD 12B被配置成用于从基于心房去极化检测并使用电学AV间期递送心房同步心室起搏切换为基于心房收缩检测并使用机械AV间期递送心房同步心室起搏。由于在心房的电学去极化之后发生心房的机械收缩,机械AV间期会比电学AV间期更短。
图4是展示了用于基于心房收缩检测递送心房同步心室起搏的LPD 12A的示例配置的功能框图。图3的LPD 12B可以具有类似的配置。然而,LPD 12A的电极36可以被LPD 12B的电极42替代,后者可以被定位在离电极34和LPD12B更远的距离,如上文参照图3所描述的。
LPD 12A包括处理模块50、存储器52、刺激模块54、电感测模块56、运动传感器58、机械感测模块60、通信模块62和电源64。电源64可以包括电池,例如可再充电或非可再充电电池。
LPD 12A中所包括的模块代表本公开的LPD 12A中可以包括的功能。本公开的模块可以包括任何离散和/或集成电子电路部件,所述部件执行能够产生归属于在此的所述模块的功能的模拟电路和/或数字电路。例如,所述模块可以包括模拟电路,例如,放大电路、滤波电路、和/或其他信号调节电路。所述模块还可以包括数字电路,例如,组合逻辑电路或时序逻辑电路、存储器设备等。可以将归属于在本文中的模块的功能具体化为一个或多个处理器、硬件、固件、软件或者其任何组合。将不同的特征描绘为模块旨在高亮不同的功能方面并且并非暗示这种模块必须由分开的硬件或软件部件来实现。相反,与一个或一个模块相关联的功能可以通过分开的硬件或软件部件执行、或者集成在共同或分开的硬件或软件部件内。
处理模块50可以包括微处理器、控制器、数字信号处理器(DSP)、专用集成电路(ASIC)、现场可编程门阵列(FPGA)或等效离散或集成逻辑电路中的任何一个或多个。在一些示例中,处理模块50包括多个部件,比如,一个或多个微处理器、一个或多个控制器、一个或多个DSP、一个或多个ASIC、或一个或多个FPGA、以及其他离散或集成逻辑电路的任何组合。另外,虽然在图4中被展示为独立功能部件,属于刺激模块54、电感测模块56、机械感测模块60、和通信模块62的一些或全部功能可以通过一个或多个微处理器、一个或多个控制器、一个或多个DSP、一个或多个ASIC、一个或多个FPGA、和/或实现处理模块50的其他分离式或集成的逻辑电路的组合实现。
处理模块50可以与存储器52通信。存储器52可以包括计算机可读指令,所述计算机可读指令当被处理模块50执行时使得处理模块50和LPD 12A的任何其他模块执行在此属于它们的各种功能。存储器52可以包括任何易失性、非易失性、磁的、或电介质,比如,随机存取存储器(RAM)、只读存储器(ROM)、非易失性RAM(NVRAM)、电可擦除可编程ROM(EEPROM)、闪存、或任何其他存储器设备。
刺激模块54和电感测模块56电耦合至电极34、36。处理模块50被配置成用于控制刺激模块54经由电极34、36生成并向心脏16递送起搏脉冲(例如,在图1中所示的示例中为右心室18)。另外,处理模块50被配置成用于控制电感测模块56监测来自电极34、36的信号,从而监测心脏16的电活动。电感测模块56可以包括从电极34、36获取电学信号的电路,以及用于滤波、放大、和另外处理电信号的电路。所述电信号包括固有心脏电活动,比如心室的去极化和复极化以及(在某些情况下)心房的去极化,并且可以被称为心脏电描记图信号。电感测模块56检测心脏电描记图信号内的心室去极化并且(在某些示例中)检测心脏电描记图信号内的心房去极化。
LPD 12A还包括运动传感器58。在一些示例中,运动传感器58包括一个或多个加速度计。在一些示例中,运动传感器58包括多个加速度计,例如三个加速度计,其中的每一个加速度计被定向为用于检测对应的轴线或向量方向上的运动。所述轴线或向量可以是正交的。在其他示例中,代替或除了所述一个或多个加速度计(比如陀螺仪、水银开关、或键合式压电晶体)之外,运动传感器58可以包括根据运动生成信号的一个或多个不同的传感器。
机械感测模块60包括用于从运动传感器58接收运动信号的电路,以及用于滤波、放大、和另外处理运动信号的电路。由于LPD 12A附装在心脏16上,运动传感器60生成根据心脏的运动(包括与心房的收缩相关联的运动、和与心室的后续收缩相关联的运动)而变化的运动信号。由于LPD 12A被植入患者14,运动传感器58所生成的运动信号也根据患者(或所经历)的任何运动而变化,例如由于患者活动。
如下文更详细描述的,机械感测模块60分析运动传感器58所生成的运动信号从而检测心房的收缩。机械感测模块60还可以分析运动信号从而检测心室收缩。为了检测心房或心室收缩,机械感测模块60可以对运动信号进行滤波从而排除心脏运动以外的分量,例如与患者14正做着或经历的运动相关联的运动信号分量。例如,为了检测心房的收缩,机械感测模块60可以对运动信号进行高通滤波,例如从而排除低于约40Hz的频率。作为另一示例,为了检测心室的收缩,机械感测模块60可以对运动信号进行高通滤波,例如从而排除低于约60Hz的频率。
机械感测模块60还可以对运动信号进行分析从而检测患者14的其他参数,比如患者活动水平。为了检测患者活动水平,机械感测模块60可以对运动信号进行滤波从而排除患者活动所导致的分量(比如与心脏收缩相关联的分量)以外的分量。例如,机械感测模块60可以对运动传感器58所生成的运动信号进行低通滤波,例如从而排除约40Hz以上的频率。处理模块50可以控制刺激模块54基于运动感测模块60所确定的活动水平递送速率响应式心室起搏。例如,处理模块50可以基于活动水平调整AV间期。
在运动传感器58包括多个加速度计或其他传感器的示例中,运动传感器58所生成的运动信号可以分别包括传感器所生成的信号中的一个或多个、或对应信号中的一个或多个(可以称为运动信号的分量信号)的组合。机械感测模块60可以根据感测向量基于所述分量信号中的一个或多个导出运动信号,其中,不同的感测向量限定所述分量信号中不同的一个或多个。在一些示例中,机械感测模块60被配置成用于根据各个不同感测向量导出运动信号。在一些示例中,机械感测模块60可以被配置成用于使用不同感测向量来感测不同参数或事件,例如心房收缩、心室收缩、和患者活动。在一些示例中,机械感测模块60被配置成用于根据多个感测向量检测事件或参数,例如心房收缩,并识别提供对所述事件的充分检测的一个或多个感应向量。
通信模块62可以包括用于与另一装置诸如编程器22(图1和图3)或患者监视器通信的任何适合的硬件(例如,天线)、固件、软件或其任何组合。在处理模块50的控制下,在通信模块62中所包括的天线的帮助下,通信模块62可以从其他设备(比如编程器22或患者监视器)接收下行遥测数据或向其发送上行遥测数据。
存储器52可以包括LPD 12A所记录的数据,例如心脏电描记图、运动信号、心率、关于心房收缩检测的信息、心室起搏功效等。在处理模块50的引导下,通信模块62可以将LDP12A所记录的数据传输至另一设备,比如编程器22。存储器52还可以对处理模块50经由通信模块62从另一设备(比如编程器22)接收的编程数据进行存储。存储器52中所存储的编程数据可以包括(作为示例)在此所描述的任何AV间期、心房收缩检测延迟期、和心房收缩检测窗口的长度。存储器52中所存储的编程数据可以另外或可替代地包括在此所描述的任何阈值,比如用于检测心房和/或心室收缩,判定起搏是否有效,或判定是否应该支持异步起搏而暂停心房同步心室起搏。存储器52中所存储的编程数据可以另外或可替代地包括处理模块50用来例如基于心脏16、患者14、或LPD 12A的已确定参数确定在此所描述的任何值的数据。
图5是展示了心脏电描记图信号70和一个或多个加速度计所生成的相应的运动信号72的曲线图。心脏电描记图信号70包括心室去极化(R波)74A和74B、以及相应的心室复极化(T波)76A和76B。心动周期78可以被定义为从一次心室去极化74A到下一次心室去极化74B的时间段,或心脏电描记图信号70或运动信号72的任何重复的基准特征之间的时间段。
如图5所展示的,心动周期78包括射血阶段,所述射血阶段还可以称为心脏收缩期。在射血阶段过长中,由于心室去极化74A而发生心室收缩80A。在射血阶段的开始和结束分别产生与心室收缩相关联的S1和S2心音。S1和S2心音分别是通过心脏16的房室瓣和半月瓣的关闭产生的。
射血阶段之后,心动周期78包括在心脏舒张过程中的被动充盈阶段,在所述心脏舒张过程中心室的被动充盈可以产生S3心音。另外,在心脏舒张接近尾声时,发生心房收缩82,主动地充盈心室。主动充盈心室可以产生S4心音。心脏电描记图70中不存在导致心房收缩82的心房去极化。另一个心动周期以心室去极化74B和产生的心室收缩80B开始。
基于对运动传感器58所生成的运动信号的分析,机械感测模块60检测心房收缩,并且还可以检测心室收缩。在心脏16收缩过程中,运动传感器58所生成的运动信号还基于心脏16的组织运动、以及任何相关联的机械扰动或振动而变化。机械扰动或振动可以包括与上文所讨论的S1-S4心音相关联的那些。例如,机械感测模块60可以基于运动信号72的表示心房收缩过程中心脏组织的运动的特征、和/或与S4心音相关联的机械扰动的存在检测心房收缩。作为另一示例,机械感测模块60可以基于运动信号72的表示心室收缩过程中心脏组织的运动的特征、和/或与S1心音相关联的机械扰动的存在检测心室收缩。
图6是展示了用于基于心房收缩检测递送心房同步心室起搏的示例技术的时序图。图6的时序图包括心室标记通道、和相应的运动信号。根据用于基于心房收缩检测递送心房同步心室起搏的示例技术,机械感测模块60识别心室(例如,右心室18)的激动。心室的激动可以是心室的固有的或起搏的去极化、或心室的机械收缩。机械感测模块60可以通过确定电感测模块56检测到心室的固有去极化90A,通过确定刺激模块54将起搏脉冲递送到了心室,或通过检测心室的机械收缩92A来识别心室的激动。
在心室激动之后开始心房收缩检测延迟期94的(即,在完成心房收缩检测延迟期94完成时开始的)心房收缩检测窗口96内,响应于识别心室的激动,机械感测模块60等待心房收缩检测延迟期94,并且然后分析运动传感器58所生成的运动信号。在图6的示例中,机械感测模块60确定电感测模块检测到心室去极化90A,并在检测到心室去极化90A之后开始心房收缩检测延迟期94的心房收缩检测窗口96内分析运动信号。
在完成心房收缩延迟期94时开始心房收缩检测窗口96可以允许机械感测模块60避免将心室收缩92A、或心动周期内心房去极化和收缩之前的其他心脏运动错误识别为心房收缩。在一些示例中,心房收缩延迟期94为至少约300毫秒。在一些示例中,心房收缩延迟期94为至少约400毫秒,或约400毫秒。在一些示例中,心房收缩检测延迟期94为至少约600毫秒。在一些示例中,处理模块50和/或机械感测模块60基于患者14的心率来调整心房收缩检测延迟期94,例如基于电感测模块56所检测到的连续的固有心室去极化之间的一个或多个间期。例如,处理模块50和/或机械感测模块60可以在心率降低时提高心房收缩检测延迟期94,并在心率提高时减小心房收缩检测延迟期94。在一些示例中,医生或其他使用者可以例如使用编程器22对心房收缩延迟期94的长度进行编程。用户可以基于个体患者特征选择心房收缩延迟期94的长度。
基于在心房收缩检测窗口96内对运动信号的分析,机械感测模块60可以检测心房收缩98。机械感测模块60可以延长心房收缩检测窗口96、和对运动信号的相关联分析,直到检测到心房收缩98,或直到电感测模块56检测到后续固有心室去极化90B,或刺激模块54递送后续心室起搏脉冲104。在一些示例中,如上所述,机械感测模块60在心房收缩检测窗口96内对运动信号进行滤波。机械感测模块60还可以在心房收缩检测窗口96内对运动信号进行整流。在一些示例中,机械感测模块60通过将心房收缩检测窗口96内的运动信号的幅度与阈值100进行比较来检测心房收缩98。在一些示例中,机械感测模块60确定运动信号的导数信号,例如经滤波和/或经整流运动信号,并将表示运动信号的变化速率的导数信号幅度与阈值100进行比较。在一些示例中,机械感测模块60检测心房收缩98的时间作为运动信号(或其导数信号)的幅度超过阈值100的最早时间点。
在一些示例中,阈值100是常数值,所述常数值可以由LPD 12A的制造商确定,或由医生使用编程器22编程。在其他示例中,机械感测模块60和/或处理模块50在一个或多个之前确定的心房收缩过程中基于运动信号的峰值幅度确定阈值100。例如,机械感测模块60和/或处理模块50可以确定阈值100是在从最近检测的心房收缩过程中的运动信号的峰值幅度的、或多次之前检测的心房收缩过程中的运动信号的平均峰值幅度的约百分之20到约百分之80范围内的值,比如约百分之50。
在一些示例中,代替或除了基于运动信号与阈值100的比较检测心房收缩98之外,机械感测模块60可以使用形态比较技术检测心房收缩98。例如,机械感测模块60可以将心房收缩检测窗口96内的运动信号与表示心房收缩过程中运动信号的一种或多种特征的一个或多个模板进行比较。机械感测模块60可以在所述比较产生的统计量表示运动信号与所述一个或多个模板之间的足够相似水平的时刻检测心房收缩98。
在一些示例中,处理模块50判定电感测模块56是否检测到导致心房收缩98的心房去极化所产生的固有心室去极化90B。例如,处理模块50可以判定电感测模块56在机械感测模块60检测到心房收缩98时开始的AV间期102内是否检测到固有心室去极化90B。如果电感测模块56在AV间期102内未检测到固有去极化90B,例如因为AV结阻滞而未发生,则处理模块50控制电刺激模块54在AV间期102截止时生成并递送心室起搏脉冲104。以这种方式,LPD12A基于心房收缩的检测递送心房同步心室起搏。
由于心房去极化与新房收缩98之间的延迟,以及心房收缩98与起搏的或固有的心室去极化应当发生的时间之间的产生的时间接近性,可以称为机械AV间期的AV间期102可以比起搏器所采取的(电学)AV间期更短,所述起搏器基于心房去极化的检测提供心房同步心室起搏。在一些示例中,AV间期102少于约100毫秒。在一些示例中,AV间期102少于约50毫秒。在一些示例中,AV间期102约30毫秒。在一些示例中,机械AV间期102比患者的电学AV间期短约20至30毫秒。
在一些示例中,处理模块50不采取AV间期。在此类示例中,在机械感测模块60检测到心房收缩98时,处理模块判定电感测模块56是否检测到了固有心室去极化90B。如果电感测模块56尚未检测到固有心室去极化90B,则处理模块50控制刺激模块54生成并递送心室起搏脉冲。
在一些示例中,LPD 12A基于脉冲104的递送所产生的心室收缩92B的检测判定心室起搏脉冲104的递送是否有效。在此类示例中,机械感测模块60基于运动信号检测心室收缩92B,例如基于以类似于基于阈值100或基于形态分析检测心房收缩98所采取的方式对运动信号与阈值106的比较。在一些示例中,机械感测模块60检测心室收缩110的时间作为当运动信号的幅度超过阈值106时递送起搏脉冲104之后的第一时间点。机械感测模块60和/或处理模块50可以确定从递送起搏脉冲104到检测到心室收缩92B的时间的间期108。机械感测模块60还可以确定心室收缩92B过程中运动信号的峰值幅度110。
在一些示例中,处理模块50基于向心室递送起搏脉冲104是否有效的判定来调整AV间期102。例如,处理模块50可以响应于确定间期108小于阈值减小AV间期102。另外或可替代地,处理模块50可以响应于确定峰值幅度110大于阈值增大AV间期102。
图7是用于基于心房收缩检测来递送心房同步心室起搏的示例技术的流程图,所述心房收缩检测可以由心室内植入的LPD(比如心脏16的右心室18内植入的LPD 12A或LPD12B)执行。图7的示例技术可以至少部分由这种LPD的处理模块50执行。根据图7的示例技术,LPD识别心室激动(120),并基于LPD的运动传感器所生成的运动信号检测后续心脏收缩(122)。然后,LPD判定是否检测到导致所检测到的心房收缩的心房去极化所造成的固有心室去极化,例如在检测到心房收缩时开始的AV间期(124)。
如果LPD检测到导致所检测到的心房收缩的心房去极化所造成的固有心室去极化(124为是),则LPD将所述固有心室去极化识别为开始下一次心动周期的心室激动(120)。如果LPD未检测到导致所检测到的心房收缩的心房去极化所造成的固有心室去极化(124为否),则LPD递送心室起搏脉冲(126)。例如,在未检测到固有心室去极化的情况下,LPD可以在AV间期截止时递送心室起搏脉冲。LPD将心室起搏脉冲的递送识别为开始下一次心动周期的心室激动(120)。LPD还可以判定心脏起搏脉冲的递送是否有效,例如,如上文参照图6所描述的(128)。
图8是展示了用于基于对运动信号(例如,图7的122)的分析检测心房收缩的示例技术的流程图,所述分析可以由心室内植入的LPD(比如心脏16的右心室18内植入的LPD12A或LPD 12B)执行。图8的示例技术可以至少部分由这种LPD的处理模块50执行。根据图8的示例技术,LPD在识别心室激动事件时开始心房收缩检测延迟期(130)。LPD在心房收缩延迟期截止时开始心房收缩检测窗口(132)。LPD在心房收缩检测窗口内分析LPD的运动传感器所生成的运动信号。
LPD在心房收缩检测窗口内对运动信号进行滤波,对经滤波信号进行整流,并在心房收缩检测窗口内生成经滤波和整流的运动信号的导数信号(134)。LPD判定心房收缩检测窗口内导数信号的幅度是否超过阈值(136)。响应于确定心房收缩检测窗口内导数信号的幅度超过阈值(136为是),LPD检测心房收缩(138)。
图9是展示了用于基于心房收缩检测来验证心房同步心室起搏的效率的示例技术的流程图,所述心房收缩检测可以由心室内植入的LPD(比如心脏16的右心室18内植入的LPD 12A或LPD 12B)执行。根据图9的示例技术,LPD基于由LPD的运动传感器在递送心室起搏脉冲之后生成的运动信号检测心室起搏脉冲所造成的心室收缩(140)。例如,LPD可以检测心室收缩的时间作为运动信号的幅度(例如,从经滤波和整流运动信号生成的导数信号的幅度)超过阈值时的时间。
LPD确定从心室起搏脉冲的递送到检测到心室收缩的时间的间隔(142)。LPD判定所述间期是否小于阈值(144)。如果所述间期小于所述阈值(144为是),则LPD减小用于在检测到心房收缩之后递送心房同步心室起搏脉冲的AV间期(146)。
如果所述间期不小于阈值,例如大于阈值(144为否),则LPD确定所检测到的心室收缩过程中运动信号的峰值幅度(148)。LPD判定所检测到的心室收缩过程中运动信号的峰值幅度是否大于阈值(150)。如果所述峰值幅度大于所述阈值(150为是),则LPD增大用于在检测到心房收缩之后递送心房同步心室起搏脉冲的AV间期(152)。如果所述峰值幅度不大于阈值,例如小于阈值(150为否),则LPD将AV间期维持其当前值(154)。
图10是用于在心房同步心室起搏模式与异步起搏模式之间切换的示例技术的流程图,所述切换可以由心室内植入的LPD(比如右心室18内植入的LPD12A或LPD 12B)执行。图10的示例技术可以至少部分由这种LPD的处理模块50执行。根据图10的示例技术,LPD以心房同步心室起搏模式运行,在所述模式下,LPD递送基于心房同步心室起搏的心房收缩检测,如在此所描述的(160)。LPD递送基于心房同步心室起搏的心房收缩检测的心房同步心室起搏模式可以与常规VDD起搏模式类似,并且可以被称为VDD起搏模式。
LPD判定患者活动水平、或患者所经历的运动水平是否超过阈值(162)。LPD可以基于LPD的运动传感器所生成的运动信号确定患者活动或运动水平。如果所述活动或运动水平超过阈值(162为是),则LPD切换至异步心室起搏模式(164)。在异步心室起搏模式下,如果在从自上一次起搏的或固有的心室去极化的VV间期内未检测到固有心室去极化,LDP可以向心室递送起搏脉冲。LPD的异步心室起搏模式可以与常规VVI或VVIR起搏模式类似,并且可以被称为VVI或VVIR起搏模式。
如果活动或运动水平未超过阈值,例如小于阈值(162为否),则LPD判定心率是否大于阈值(例如大于约80次每分钟或约100次每分钟)和/或不规律(166)。LPD可以基于之前的心室去极化之间的间期确定心率及其规律性。如果所述心率大于阈值和/或不规律(166为是),则LPD切换至异步心室起搏模式(164)。
如果心率不大于阈值和/或不规律(166为否),则LPD判定是否能够基于对LPD的运动传感器所生成的运动信号的分析检测心房收缩(168)。例如,如果确定了针对预定数量的心动周期未检测到心房收缩,LPD可以确定不能检测心房收缩。所述预定数量的心动周期可以是任何数量的一个或多个心动周期,所述周期可以是连续的或非连续的。例如,所述预定数量的心动周期可以是三。如果LPD确定了不能检测心房收缩(168为否),则LPD切换至异步心室起搏模式(170)。如果LPD确定了不能检测心房收缩(168为否),则LPD还可以改变运动信号感测向量,LPD根据所述运动信号感测向量从运动传感器(例如,运动传感器的多个加速度计)所生成的多个信号中的一个或多个导出运动信号(172)。
如果LPD确定了能够检测心房收缩(168为是),则LPD可以继续根据心房同步心室起搏模式递送心室起搏(160)。进一步,在根据异步起搏模式(164,170)递送起搏一段时间之后,或直到导致切换至异步模式的条件已经失效,LPD可以切换至根据心房同步心室起搏模式递送心室起搏。
图11是用于在响应于心房去极化的心房同步心室起搏与响应于心房收缩的心房同步心室起搏之间切换的示例技术的流程图,所述切换可以由心室(比如心室18)内植入的能够检测心房的去极化(比如右心室20)的LPD执行。耦合至感测延伸部40的LPD 12B是这种LPD的一个例子,虽然LPD 12A还可以被配置成用于检测心房的去极化。图11的示例技术可以由这种LPD的处理模块50执行。
根据图11的示例技术,在检测到心房去极化之后,LPD以第一电学AV间期递送心房同步起搏(180)。LPD判定是否不能检测到心房去极化(182)。例如,如果确定了针对预定数量的心动周期尚未检测到心房去极化,例如在预定数量的心动周期的连续心室去极化之间未检测到心房去极化,LPD可以确定不能检测到心房去极化。所述预定数量的心动周期可以是任何数量的一个或多个心动周期,所述周期可以是连续的或非连续的。如果LPD确定不能检测心房去极化(182为是),则LPD可以激活心房收缩检测,并切换至在检测到心房收缩之后以第二机械AV间期递送心房同步起搏(184)。如果LPD确定能够检测心房去极化(182为否),或某个时候基于心房收缩检测递送心房同步心室起搏(184),则LPD可以继续基于心房去极化检测切换回递送心房同步心室起搏(180)。
本公开中描述的技术,包括附属于LPD 12、编程器22或各种组成部件的那些技术可以至少部分地在硬件、软件、固件或其任何组合中实现。例如,所述技术的各个方面可以在一个或多个处理器中实现,包括一个或多个微处理器、DSP、ASIC、FPGA或者任何其他等效集成的或离散的逻辑电路,以及此类部件的任何组合,所述部件在编程器(诸如内科医师或患者编程器、刺激器、图像处理设备或其他设备)中被具体化。术语“处理器”或“处理电路”通常可以指前述逻辑电路中的任何电路(单独地或与其他逻辑电路组合),或者任何其他等效电路。
此类硬件、软件、固件可以在同一设备或单独设备内实现以便支持本公开中描述的各种操作和功能。此外,所描述的单元、模块或部件中的任一项可以被实现为在一起或单独地作为分立但彼此协作的逻辑设备。作为模块或单元的不同特征的描绘旨在强调不同的功能方面,并且并不一定暗示此类模块或单元必须通过单独的硬件或软件部件来实现。相反,与一个或多个模块或单元相关联的功能可以通过单独的硬件或软件部件来执行、或集成在共同的或单独的硬件或软件部件内。
当在软件中实现时,授予本公开中描述的系统、设备和技术的功能可以被具体化为计算机可读介质(诸如RAM、ROM、NVRAM、EEPROM、闪存、磁性数据存储介质、光学数据存储介质等)上的指令。所述指令可以执行来支持在本公开中描述的功能的一个或多个方面。
已经对各种不同的示例进行了描述。这些示例和其他示例在以下权利要求书的范围内。
Claims (12)
1.一种无引线起搏设备,所述无引线起搏设备被配置成用于递送心房同步心室起搏,所述无引线起搏设备包括:
多个电极;
运动传感器,所述运动传感器被配置成用于根据患者的心脏的运动生成运动信号;
刺激模块,所述刺激模块耦合至所述多个电极,其中,所述刺激模块被配置成用于生成起搏脉冲并且经由所述多个电极将所述起搏脉冲递送至所述心脏的心室;
电感测模块,所述电感测模块耦合至所述多个电极,其中,所述电感测模块被配置成用于在经由所述多个电极感测到的心脏电描记图内检测所述心室的去极化;
机械感测模块,所述机械感测模块耦合至所述运动传感器并且被配置成用于:
从所述运动传感器接收所述运动信号;
识别所述心室的激动;
在识别到所述心室的所述激动时,发起心房收缩检测延迟期;
在完成所述心房收缩检测延迟期时开始的心房收缩检测窗口内分析所述运动信号;并且
基于在所述心房收缩检测窗口内对所述运动信号的所述分析检测所述心脏的心房的收缩;
处理模块,所述处理模块被配置成用于控制所述刺激模块生成起搏脉冲并响应于由所述机械感测模块检测到所述心房的收缩而经由所述多个电极将所述起搏脉冲递送至所述心室;以及
壳体,所述壳体被配置成被植入在所述心室内,其中,所述壳体封闭所述运动传感器、所述刺激模块、所述电感测模块、所述机械感测模块、和所述处理模块。
2.如权利要求1所述的无引线起搏设备,其中,为了识别所述心室的所述激动,所述机械感测模块被配置成用于执行以下各项中的至少一项:
确定所述电感测模块检测到所述心室的去极化;
确定所述刺激模块生成了起搏脉冲并经由所述多个电极将所述起搏脉冲递送至所述心室;或者
基于所述运动信号检测所述心室的收缩。
3.如权利要求1至2中任一项所述的无引线起搏设备,其中,所述心房收缩检测延迟期为至少400毫秒。
4.如权利要求1至3中任一项所述的无引线起搏设备,其中,所述机械感测模块被配置成用于基于所述患者的心率调整所述心房收缩延迟期。
5.如权利要求1至4中任一项所述的无引线起搏设备,其中,所述处理模块被配置成用于:
确定所述电感测模块在所述机械感测模块检测到所述心房的收缩时开始的房室(AV)间期内未检测到所述心室的去极化;并且
控制所述刺激模块生成所述起搏脉冲并响应于所述确定而经由所述多个电极将所述起搏脉冲递送至所述心室。
6.如权利要求1至5中任一项所述的无引线起搏设备,其中,所述AV间期小于100毫秒。
7.如权利要求1至6中任一项所述的无引线起搏设备,其中,所述机械感测模块被配置成用于在将所述起搏脉冲递送至所述心室之后基于所述运动信号检测所述心室的收缩,并且所述处理模块被配置成用于:
基于对所述心室的所述收缩的检测,判定所述起搏脉冲至所述心室的所述递送是否有效;并且
基于所述起搏脉冲至所述心室的所述递送是否有效的所述判定,调整所述AV间期。
8.如权利要求1至7中任一项所述的无引线起搏设备,其中,所述处理模块被配置成用于:
确定从所述起搏脉冲的所述递送到检测到所述心室的所述收缩的间隔小于阈值;并且
响应于所述确定从所述起搏脉冲的所述递送到检测到所述心室的所述收缩的所述间隔小于所述阈值而减小所述AV间期。
9.如权利要求1至8中任一项所述的无引线起搏设备,
其中,所述机械感测模块被配置成用于:
基于所述运动信号检测心室收缩的峰值;并且
在所述峰值处确定所述运动信号的幅度,并且
其中,所述处理模块被配置成用于:
确定所述幅度大于所述阈值;并且
响应于所述确定所述幅度大于所述阈值而增大所述AV间期。
10.如权利要求1至9中任一项所述的无引线起搏设备,其中,所述处理模块被配置成用于:
确定所述机械感测模块在预定数量的一个或多个心动周期内未检测到所述心房的收缩;并且
控制所述刺激模块生成所述起搏脉冲并响应于所述确定而根据异步心室起搏模式将所述起搏脉冲递送至所述心室。
11.如权利要求1至10中任一项所述的无引线起搏设备,其中,所述处理模块被配置成用于:
基于由所述电感测模块所检测到的去极化确定所述患者的心率;
确定所述心率超过阈值;并且
控制所述刺激模块生成所述起搏脉冲并响应于确定所述心率超过所述阈值而根据异步心室起搏模式将所述起搏脉冲递送至所述心室。
12.如权利要求1至11中任一项所述的无引线起搏设备,
其中,所述运动传感器包括多个加速度计,所述多个加速度计中的每一个加速度计沿着对应轴线定向并被配置成用于生成对应的加速度计信号,
其中,机械感测模块根据第一感测向量基于所述加速度计信号中的第一一个或多个加速度计信号导出所述运动信号,
其中,所述处理模块被配置成用于:
确定所述机械感测模块在预定数量的一个或多个心动周期内未检测到所述心房的收缩;并且
控制所述机械感测模块响应于所述确定而根据第二感测向量基于所述加速度计信号中的第二一个或多个加速度计信号导出所述运动信号。
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USRE48197E1 (en) | 2020-09-08 |
CN106535987B (zh) | 2019-07-05 |
US20160023000A1 (en) | 2016-01-28 |
WO2016014352A1 (en) | 2016-01-28 |
CN110141786B (zh) | 2023-03-21 |
EP3171937B1 (en) | 2018-10-10 |
CN110141786A (zh) | 2019-08-20 |
EP3444008B1 (en) | 2021-04-14 |
US9399140B2 (en) | 2016-07-26 |
EP3171937A1 (en) | 2017-05-31 |
EP3444008A1 (en) | 2019-02-20 |
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