CN109414582A - 使用皮下感测p波进行再同步起搏管理的心脏治疗系统 - Google Patents
使用皮下感测p波进行再同步起搏管理的心脏治疗系统 Download PDFInfo
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Abstract
公开了被配置为提供心脏再同步治疗和/或心动过缓起搏治疗系统和可植入设备。位于患者心脏中的第一设备被配置为接收来自第二设备的通信,并响应于或根据接收到的通信而递送起搏治疗。位于别处的第二设备被配置为确定已经发生心房事件并且与第一设备通信以触发起搏治疗。除了其他增强外,第二设备可以被配置为通过使用矢量选择和心房事件加窗来感测心房事件。还会讨论和处理异常情况。
Description
相关申请的交叉引用
本申请要求于2016年6月27日提交的美国临时专利申请序列号62/355,121的权益和优先权,其公开内容通过引用并入本文。
背景技术
心脏再同步治疗(CRT)使电激活再同步并从而使心脏腔室的收缩再同步,以提高起搏效率。益处可以包括增加运动能力和减少住院治疗和死亡率。CRT设备通过控制或影响一个或多个心脏腔室相对于一个或多个其他心脏腔室的收缩定时来操作。例如,一个或多个心室中的一个或多个的收缩可以相对于心房的收缩而定时,或者左心室和右心室的收缩可以相对于彼此而定时。
当多个激活信号同时影响相同的组织时,发生“融合”搏动。例如,一个心室的起搏与另一个心室的自发激活之间的电融合(例如,起搏的左心室激活和自发的右心室激活)产生了融合搏动。在许多情况下,融合搏动的生成是心脏再同步化的目标。
现有系统通常包括经由经静脉引线被耦合到植入式脉冲发生器的心内电极。这种系统的引线被众所周知为引入了各种不健全并且倾向于最终的导体和/或绝缘体故障。引线的存在及其在CRT系统中已知的不健全和故障可能减少了在所指示的心力衰竭患者群体中的使用。
新一代起搏器包括无引线心脏起搏器(LCP),其可以被完全植入在心脏内并且不需要经静脉(或任何)引线。这种设备在某些地方是市场上可买到的,但目前表示用于心动过缓起搏。LCP还呈现了以下机会:向使用经静脉引线的传统CRT治疗提供替代方案。期望一种针对使用LCP提供CRT治疗的新的和可替代的系统、设备和方法。
发明内容
本发明人尤其已经认识到除了其他以外,要解决的问题是使用由多个可植入设备收集到的信息来管理CRT。为了使同步性差的心脏腔室的行为再同步,有必要了解在不同的腔室中发生了什么以及何时发生。在一些示例中,被植入在心脏的单个腔室中的LCP可以接收从单独的设备(诸如另一个LCP或心外设备,诸如皮下心脏监视器,或皮下可植入心脏除颤器(SICD))发送的数据,并且使用接收到的数据来对将起搏脉冲递送到心室进行定时。在实施例中,LCP接收来自SICD的指示(在特定时间处已经被SICD检测到指示出心房去极化(其相对于心房收缩而发生)的P波),并且LCP响应于所传送的信息并且递送起搏脉冲。
在另一示例中,LCP可以响应于由第二设备执行的分析而接收用于起搏的命令。在特定示例中,SICD可以检测P波、确定相对于P波的定时和/或其他参数,并且然后SICD可以命令LCP进行治疗。在另一示例中,LCP可以根据自确定定时序列来递送起搏脉冲,但是可以偶尔或周期性地从诸如SICD的第二设备接收补充定时信息。例如,SICD可以确定被诱发的响应特性以确保产生融合搏动;如果没有观察到融合,则SICD可以向LCP发出通信。在该示例中,SICD或LCP可以通过调整所递送治疗的定时或能量或其他特性来确定要采取的校正步骤。
在其他示例中,患者可以通过使SICD检测P波并且与LCP通信来接收心动过缓起搏。例如,患有房室结性阻滞(AV阻滞)的患者可能表现出P波不会自然地传导到心室,并且位于例如右心室的LCP可以响应于传送给它的数据而递送起搏脉冲。通信可以在每个搏动处发生,或者可以是周期性的或偶尔的以确认操作和/或提示定时增强。
第一非限制性示例采用可植入设备系统的形式,包括:第一医疗设备,其被配置为向患者的心脏递送起搏治疗;和第二医疗设备,其被配置为感测患者的心脏活动;其中,第一医疗设备被配置为从第二医疗设备接收通信;其中,第二医疗设备被配置为检测患者的心脏中的心房事件并向第一医疗设备发出通信;其中,第一医疗设备被配置为响应于由第二医疗设备发出的通信而将治疗递送到患者的心脏。
另外地或可替换地,第二非限制性示例采用如第一非限制性示例中所述的系统的形式,其中第二医疗设备被配置用于检测心房事件的初始化序列,初始化序列包括:检测患者的至少第一心动周期和第二心动周期;建立用于检测心房事件的窗口;其中,第二医疗设备被配置为在用于检测心房事件的窗口期间观察患者的心脏信号,以便检测心房事件。
另外地或可替换地,第三非限制性示例采用如第二非限制性示例中所述的系统的形式,其中第二医疗设备被配置为相对于心室事件的特征而建立用于检测心房事件的窗口。
另外地或可替换地,第四非限制性示例采用如第二非限制性示例中所述的系统的形式,其中第二医疗设备被配置为检测或确定发生由第一医疗设备输出的治疗,并且相对于由第一医疗设备输出的治疗而建立用于检测心房事件的窗口。
另外地或可替换地,第五非限制性示例采用如第二非限制性示例中所述的系统的形式,其中第二医疗设备被配置为使用至少第一心动周期和第二心动周期来计算复合心动周期数据集,并且使用复合心动周期数据集来建立用于检测心房事件的窗口。
另外地或可替换地,第六非限制性示例采用如第二非限制性示例中所述的系统的形式,其中初始化序列还包括确定心房事件的特性,此外,其中第二医疗设备被配置为使用在初始化序列期间所确定的特性以便检测心房事件。
另外地或可替换地,第七非限制性示例采用如第六非限制性示例中所述的系统的形式,其中心房事件的特性包括以下中的至少一个:振幅;与一个或多个先前心室事件进行比较的相对振幅;与心动周期期间的平均振幅进行比较的相对振幅;或最大斜率或最小斜率。
另外地或可替换地,第八非限制性示例采用如第二非限制性示例中所述的系统的形式,其中第二医疗设备被配置为确定在用于检测心房事件的窗口期间捕获到的信号是否与所存储的心房事件模板或动态心房事件模板匹配。
另外地或可替换地,第九非限制性示例采用如第一非限制性示例中所述的系统的形式,其中第二医疗设备包括被配置用于感测心脏信号的多个电极,并且第二医疗设备被配置为执行感测矢量选择例程,其中:第二医疗设备从由多个电极限定的多个感测矢量分析信号,并选择用于检测心室事件的第一感测配置;以及第二医疗设备从由多个电极限定的多个感测矢量分析信号,并选择用于检测心房事件的第二感测配置。
另外地或可替换地,第十非限制性示例采用如第九非限制性示例中所述的系统的形式,其中第二医疗设备被配置为确定用于检测心房事件的心房感测窗口并且被配置为选择性地使用第二感测配置来确定心房事件是否在心房感测窗口中发生。
另外地或可替换地,第十一非限制性示例采用如第九非限制性示例中所述的系统的形式,其中第二医疗设备被配置为使用第二感测配置来确定用于感测心房事件的一个或多个参数。
另外地或可替换地,第十二非限制性示例采用如第九非限制性示例中所述的系统的形式,其中第二医疗设备被配置为建立用于心房事件的模板以用于确定使用第二感测配置所捕获的信号是否是预定类型的心房事件。
另外地或可替换地,第十三非限制性示例采用如第一至第十二非限制性示例中任一个所述的系统的形式,其中治疗被配置为治疗心动过缓。
另外地或可替换地,第十四非限制性示例采用如第一至第十二非限制性示例中任一个所述的系统的形式,其中治疗被配置为改进心脏同步和收缩疗效。
另外地或可替换地,第十五非限制性示例采用如第十四非限制性示例中所述的系统的形式,其中通信被配置为指示第二医疗设备已检测到心房事件,并且第一医疗设备被配置为确定相对于心房事件的定时要何时递送治疗。
另外地或可替换地,第十六非限制性示例采用如第十四非限制性示例中所述的系统的形式,其中通信被配置为命令第一设备在特定时间处递送治疗。
另外地或可替换地,第十七非限制性示例采用如第一至第十六非限制性示例中任一个所述的系统的形式,其中第一医疗设备是无引线心脏起搏器,并且第二医疗设备是可植入心脏监视器。
另外地或可替换地,第十八非限制性示例采用如第一至第十六非限制性示例中任一个所述的系统的形式,其中第一医疗设备是无引线心脏起搏器,并且第二医疗设备是皮下可植入除颤器。
另外地或可替换地,在第十九非限制性示例中,本发明可以采用提供心脏再同步治疗和/或心动过缓起搏治疗的方法的形式,包括使用如第一至第十八非限制性示例中任一个所述的系统。
第二十非限制性示例采用可植入医疗设备的形式,可植入医疗设备包括:多个可植入电极;操作电路,其用于分析使用多个可植入电极捕获到的信号;以及通信电路,其用于与第二可植入医疗设备进行通信;其中操作电路被配置为执行感测矢量选择例程,其中:操作电路分析来自由多个电极限定的多个感测矢量的信号,并选择用于检测心室事件的第一感测配置;以及操作电路分析来自由多个电极限定的多个感测矢量的信号,并选择用于检测心房事件的第二感测配置;并且进一步地,其中:操作电路被配置为使用第二感测配置来确定是否检测到心房事件;并且响应于确定已经检测到心房事件,操作电路被配置为与第二医疗设备进行通信。
另外地或可替换地,第二十一非限制性示例采用如第二十非限制性示例中所述的系统的形式,其中操作电路被配置为确定用于检测心房事件的心房感测窗口并且被配置为选择性地使用第二感测配置以确定心房事件是否在心房感测窗口中发生,其中操作电路被配置为定义与使用第一感测配置感测到的心室感测事件有关的心房感测窗口。
另外地或可替换地,第二十二非限制性示例采用如第二十非限制性示例中所述的系统的形式,其中操作电路被配置为确定用于检测心房事件的心房感测窗口并且被配置为选择性地使用第二感测配置以确定心房事件是否在心房感测窗口中发生,其中操作电路被配置为定义与由第二医疗设备输出的检测到的治疗有关的心房感测窗口。
另外地或可替换地,第二十三非限制性示例采用如第二十非限制性示例中所述的系统的形式,其中操作电路被配置为确定针对使用第二感测配置来感测心房事件的一个或多个参数。
另外地或可替换地,第二十四非限制性示例采用如第二十非限制性示例中所述的系统的形式,其中操作电路被配置为建立用于心房事件的模板以用于确定使用第二感测配置捕获到的信号是否是预定类型的心房事件。
第二十五非限制性示例采用可植入医疗设备的形式,可植入医疗设备包括:多个可植入电极;操作电路,其用于分析使用多个可植入电极捕获到的信号;以及通信电路,其用于与第二可植入医疗设备进行通信;其中,操作电路被配置为执行用于检测心房事件的初始化序列,初始化序列包括:检测患者的至少第一心动周期和第二心动周期;建立用于检测心房事件的窗口;其中操作电路被配置为在用于检测心房事件的窗口期间观察患者的心脏信号,以便检测心房事件。
另外地或可替换地,第二十六非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为相对于心室事件的特征而建立用于检测心房事件的窗口。
另外地或可替换地,第二十七非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为检测或确定由第二医疗设备输出的治疗的发生,并且相对于由第二医疗设备输出的治疗而建立用于检测心房事件的窗口。
另外地或可替换地,第二十八非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为使用至少第一心动周期和第二心动周期来计算复合心动周期数据集,并且使用复合心动周期数据集来建立用于检测心房事件的窗口。
另外地或可替换地,第二十九非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为使得初始化序列还包括确定心房事件的特性,进一步地,其中操作电路被配置为确定使用在初始化序列期间所确定的特性以便检测心房事件。
另外地或可替换地,第三十非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为使得心房事件的特性包括以下中的至少一个:振幅;与一个或多个先前心室事件进行比较的相对振幅;与心动周期期间的平均振幅进行比较的相对振幅;或最大斜率或最小斜率。
另外地或可替换地,第三十一非限制性示例采用如第二十五非限制性示例中所述的系统的形式,其中操作电路被配置为确定在用于检测心房事件的窗口期间捕获到的信号是否与所存储的心房事件模板或动态心房事件模板匹配。
另外地或可替换地,第三十二非限制性示例采用如第二十至第三十一非限制性示例中任一个所述的可植入医疗设备系统的形式,其中第一医疗设备是皮下可植入心脏监视器,并且第二医疗设备是无引线心脏起搏器。
另外地或可替换地,第三十三非限制性示例采用如第二十至第三十一非限制性示例中任一个所述的可植入医疗设备系统的形式,其中第一医疗设备是皮下可植入心脏除颤器,并且第二医疗设备是无引线心脏起搏器。
另外或可替代地,第三十四非限制性示例采用治疗患者的方法的形式,该方法包括:通过使用如第二十至第三十三非限制性示例中任一个所述的系统而提供心脏再同步治疗。
另外或可替代地,第三十五非限制性示例采用治疗患者的方法的形式,该方法包括:通过使用如第二十至第三十三非限制性示例中任一个所述的系统而提供心动过缓起搏治疗。
这旨在提供对本专利申请的主题的概述。其不旨在提供对本发明的排他性或详尽的解释。包括详细描述以提供关于本专利申请的其他信息。
附图说明
在不一定按比例绘制的附图中,相同的数字可以描述不同视图中的类似组件。具有不同字母后缀的相同数字可以表示类似组件的不同实例。附图通过示例而非限制的方式一般示出了本文件中讨论的各种实施例。
图1示出了具有多个可植入医疗设备的患者;
图2示出了可植入医疗设备的框图;
图3示出了说明性可植入无引线心脏起搏器;
图4示出了说明性心脏信号;
图5A示出了此时指示正被递送的起搏治疗的另一说明性心脏信号;
图5B示出了信号的示例定时基准;
图5C-5D示出了检测P波的方法;
图6示出了可以分析信号特征的方式;
图7示出了另一心脏信号以说明实施例的操作;
图8、9、以及10A-10B示出了用于说明性示例的框图;
图11以方框流程图的形式示出了对协作设备的操作;
图12A-12B示出了处理跨设备定时的不同方式;
图13-17以方框流程图的形式示出了对协作设备的操作;并且
图18示出了植入前的过程流程。
具体实施方式
应该参考附图阅读以下描述。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。
图1示出了具有第一植入式医疗设备的患者10,第一植入式医疗设备被显示为在心脏12内植入的无引线心脏起搏器(LCP)14,为了说明的目的其在左心室中。LCP 14可以被植入在其他腔室中,诸如右心室或心房中,并且可以提供多于一个LCP。
一种皮下可植入除颤器(SICD)16形式的第二医疗设备,其具有左腋窝筒和具有分叉以在18和20处提供两个指状物的引线。引线包括多个电极,诸如在20、22、24和26处的钮扣或环形电极,并且还可以包括如28处所示的一个或多个线圈电极。
图1中的示图显示了引线18/20的分叉;在其他实施例中,可以提供具有单个细长构件的更简单的引线,单个细长构件上具有多个电极,诸如例如,题为ELECTRODE SPACINGIN A SUBCUTANEOUS IMPLANTABLE CARDIAC STIMULUS DEVICE的美国专利9,079,035中所示,其公开内容通过引用并入本文。可以提供多个引线而不是分叉,如例如,在题为SUBCUTANEOUS CARDIAC STIMULATOR DEVICE HAVING AN ANTERIORLY POSITIONEDELECTRODE的美国专利7,149,575中所示的。
引线18/20可以被完全皮下植入,诸如通过延伸穿过胸部的前部或后部,或者通过沿侧向/内侧方向并然后沿着胸骨向上朝向头部部分地穿过胸部。皮下引线植入的一些示例和讨论可以在题为APPARATUS AND METHOD FOR SUBCUTANEOUS ELECTRODE INSERTION的美国专利号8,157,813和题为SUBCUTANEOUS LEADS AND METHODS OF IMPLANT ANDEXPLANT的美国PG公开号20120029335中找到,其公开内容通过引用并入本文。另外的皮下放置在题为SUBCUTANEOUS ONLY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ANDOPTIONAL PACER的美国专利6,721,597和上面提到的美国专利7,149,575中进行了讨论,其公开内容通过引用并入本文。可以替代地使用胸骨下放置,其中一个指状物18/20或引线的整个远端部(即,远离筒16的端部)进入胸骨下方,诸如在题为SUBSTERNAL PLACEMENT OF APACING OR DEFIBRILLATING ELECTRODE的美国PG专利公开号2017/0021159中,其公开内容通过引用并入本文。
设备14和16可以彼此通信和或与外部编程器30通信。编程器30可以可选地使用棒(wand)(未示出)和/或皮肤电极32和34以促进通信。例如,皮肤电极32可以用于与可植入设备进行传导通信。传导通信是经由电信号进行的通信,所述电信号经由患者组织传播并且由或更多或更少的普通电极生成。通过使用可植入设备的现有电极,传导通信不依赖于天线和振荡器/谐振电路,其具有经调谐的中心频率或发射机和接收机两者共有的频率。
对于诸如RF或感应通信的其他通信方法,编程器28可以使用编程棒或者可以具有与编程器28外壳集成的天线以用于通信。虽然没有详细示出,但是编程器28可以包括任何合适的用户界面,包括本领域广泛公知的屏幕、按钮、键盘、触摸屏、扬声器以及各种其他特征。
皮下可植入除颤器可以包括,例如Boston Scientific Corporation提供的Emblem S-ICD SystemTM。皮下除颤器和LCP设备的组合在例如美国PG专利公开号20160059025、20160059024、20160059022、20160059007、20160038742、20150297902、20150196769、20150196758、20150196757和20150196756中进行了讨论,其公开内容通过引用并入本文。例如,皮下除颤器和LCP可以交换与心脏功能或设备状态有关的数据,并且可以作为系统一起操作以确保适当地确定心脏状况(诸如是否发生室性快速性心律失常)以及协调治疗,诸如通过在皮下除颤器递送除颤电击之前使LCP递送抗心动过速起搏以试图转换某些心律失常。
在随后的若干示例中,重点在于通过至少两个设备14、16的协作来创建有效的CRT治疗。在可以使用类似的概念以使用从第二设备接收到的信息利用LCP进行起搏的其他示例中,可以替代地提供心动过缓起搏。下面若干示例可以用于提供心动过缓起搏作为对具有房室(AV)阻滞的患者的治疗,其中致使心房收缩的电信号无法被传导到心室。对于这样的患者,SICD 16(或其他第二设备,诸如心房放置的LCP或检测装置,或皮下监视器)可以检测P波并向LCP 14发出命令或请求起搏治疗或简单地指示已注意到P波的通信。
在一些示例中,不是诸如图1中所示的皮下除颤器16的治疗设备,第二可植入医疗设备可以采用可植入监视设备的形式。心脏监视器可以是,例如环路监视器,其在选择条件下使用其外壳上的和/或利用引线附接到其上的两个或更多个感测电极来捕获数据。已经发现这种监视器用于帮助诊断可能不常见或间歇性或具有非特异性症状的心脏病。例如,可以使用可植入或甚至是可佩戴心脏监视器进行跟踪未经解释的心脏收缩或确定其他心脏病。在本发明的上下文中,可以使用可植入或甚至是可佩戴心脏监视器来代替如任何以下示例中所述的皮下除颤器。
若干示例集中在使用左心室LCP 14上。然而,一些示例可以替代地使用右心室LCP40,并且其他示例可以包括左心室LCP 14和右心室LCP 40两者。例如,在关于具有AV阻滞的患者的心动过缓起搏而提到对LCP的使用的情况下,可以存在右心室LCP,有或没有左心室LCP。在其他示例中,三个植入系统可以包括两个LCP设备14、40,以及诸如SICD 16的皮下设备。在另其他示例中,还可以包括心房放置的LCP(未示出)。
图2示出了可植入医疗设备的框图。示图指示了设备50内的各种功能块,包括处理块52、存储器54、电源56、输入/输出电路58、治疗电路60和通信电路62。这些功能块构成了设备的操作电路。I/O电路58可以耦合到设备50外壳上的一个或多个电极64、66,并且还可以耦合到头部68,以用于附接到具有附加电极72的一个或多个引线70。通信电路62可以耦合到用于无线电通信(诸如Medradio、ISM或其他RF)的天线74,或者可替换地耦合到用于感应通信的线圈,和/或可以经由I/O电路58耦合到电极64、66、72的组合,以进行传导通信。
处理块52通常将控制设备50中的操作,并且可以包括适合于其目的的微处理器或微控制器和/或其他电路和逻辑。处理块52可以包括用于设备功能(诸如将模拟信号转换为数字数据、处理数字信号、检测生物信号中的事件等)的专用电路或逻辑。存储器块可以包括RAM、ROM、闪存和/或其他存储器电路,以用于存储与设备50的使用、状态和历史有关的设备参数、编程代码以及数据。电源56通常包括一个到多个电池,其取决于设备50而可以是可充电的或可以不是可再充电的。针对可再充电系统,另外还会有用于电池的充电电路(未示出)。
I/O电路58可以包括各种开关或多路复用器,以用于选择输入和输出以供使用。I/O电路58还可以包括用于预处理输入信号的滤波电路和放大器。在一些应用中,I/O电路将包括H桥以便于高功率输出,虽然也可以使用其他电路设计。治疗块60可以包括用于提供电输出的电容器和充电电路、调制器和频率发生器。可植入监视设备可以省略治疗块60,且可以具有简化后的I/O电路,简化后的I/O电路简单地用于捕获电信号或其他信号,诸如化学信号或运动信号。
通信电路62可以包括频率发生器/振荡器和混频器,以用于创建输出信号来经由天线74传送。例如,一些设备50可以包括用于通信电路62的单独或甚至现成的ASIC。对于使用感应通信输出的设备,可以包括感应线圈。设备也可以使用光学或声学通信方法,并且也可以包括合适的电路、换能器、发生器和接收机,以用于这些通信模式以及或替代上面所讨论的那些。
如本领域技术人员将理解的,可以提供除图2中所示的电路之外的附加电路。例如,一些设备50可以包括簧片开关、霍尔效应设备或其他磁反应元件以便于磁铁唤醒、复位或用户对设备的治疗抑制、或启用MRI保护模式。缺少引线的设备可以在其外壳上具有多个电极,如64、66处所指示的,但是可以省略用于耦合到引线70的头部64。在一个示例中,无引线设备可以使用头部以耦合到附接或环绕设备外壳的电极支撑件特征。
图3示出了说明性LCP设计。LCP 100被示出为包括多个功能块,多个功能块包括通信模块102、脉冲发生器模块104、电感测模块106和机械感测模块108。处理模块110可以从其他模块102、104、106、108接收数据并且生成针对由其他模块102、104、106、108输出的命令。在112处突出能量存储模块,并且可以采用可再充电或不在可充电电池,或超级电容器或任何其他合适元件的形式。在题为SYSTEMS AND METHODS FOR RATE RESPONSIVE PACINGWITH A LEADLESS CARDIAC PACEMAKER的美国PG专利公开20150360036、题为MULTI-CHAMBER LEADLESS PACEMAKER SYSTEM WITH INTER-DEVICE COMMUNICATION的美国PG专利公开20150224320、题为REFRACTORY AND BLANKING INTERVALS IN THE CONTEXT OFMULTI-SITE LEFT VENTRICULAR PACING的美国PG专利公开20160089539和题为MEDICALDEVICE WITH TRIGGERED BLANKING PERIOD的美国PG专利公开20160059025以及其他专利公开中进一步讨论了内部电路的各种细节,其可以包括微处理器或状态机架构。说明性架构也可以类似于MicraTM(Medtronic)或NanostimTM(St.Jude Medical)无引线起搏器中发现的架构。
所示的设备具有114处的第一端部电极和116处的第二端部电极。多个尖齿(tine)118可以在几个方向上从设备延伸。尖齿118可用于将设备固定在心室内的适当位置。另一种附接结构在120处示出,并且如果需要可以采用螺旋形螺钉的形式。在一些示例中,尖齿118用作唯一的附接特征。组织附接和取回特征可以被包括在LCP中,其包括题为LEADLESSCARDIAC PACEMAKER AND RETRIEVAL DEVICE的美国PG专利公开20150051610和题为SYSTEMAND METHODS FOR CHRONIC FIXATION OF MEDICAL DEVICES的美国PG专利公开20150025612中所示的那些特征,其公开内容通过引用并入本文。固定和获取结构可以替代地类似于MicraTM(Medtronic)或NanostimTM(St.Jude Medical)无引线起搏器的固定和获取结构。
图4示出了说明性心脏信号。远场表示(即,仅使用既不在心脏中也不在心脏上的电极所捕获到的信号)用迹线150示出。迹线150使用标准惯例以P波、R波(当与先前的Q波和随后的S波结合时,其可以被称为QRS波群)以及后来的T波来标记。P波表示与心房收缩相关联的心房去极化以加载心室,R波或QRS波群表示与心室收缩相关联的心室去极化以将血液泵送到身体和肺部,并且T波与使心室肌肉再极化以准备下一次搏动的电活动相关联。对于心力衰竭和/或不同步,对这些个体事件的定时可能是异常的或反常的,并且去极化波的形状可以与通过例如具有宽的多的QRS波群或R波而显示的形状不同。
对于具有经静脉引线的传统系统,放置心内电极以检测心房去极化,同时还向一个或两个心室递送再同步起搏治疗。结果,单个设备的电路将直接接收P波的信息,允许以起搏脉冲的定时隔递送以再同步收缩并提高泵送效率。然而,对于如图1中的系统,LCP可能无法从心室中的植入位置识别心房中生成的P波。因此,在本发明的若干实施例中,LCP依赖于诸如皮下心脏监视器或SICD的第二医疗设备来确定是否发生P波以及何时发生P波。然而,为了促进这种交互,本发明人已经标识了几种潜在的优化。
例如,可以优化SICD(或皮下心脏监视器)以用于检测R波和/或QRS波群,以便确保可以适当且快速地识别致命的心律失常(心室纤维性颤动和/或多形室性心动过速)。可以使用来自对这种设备的R波检测的单独参数和/或分析来检测P波。在一些示例中,定义用于P波检测的时间窗口,在该时间窗口期间SICD可以特定地寻找P波。可以通过分析从患者获得的心脏信号,使用例如诸如R波/QRS波群或T波的心室事件来作为图4中所示的定时延迟152、154的起始点而定义这种窗口。持续时间152、154可以是动态的,以使用从患者收集到的数据或使用公式或接受的关系来调整患者的总体搏动率。
另一优化可以包括使SICD(或皮下心脏监视器)使用专用感测配置来分别检测心室事件并使用第二单独定义的专用感测配置来分别检测心房事件。例如,EmblemTM S-ICD系统执行矢量选择以将具有最佳R波振幅和信噪比的感测矢量识别为用于感测患者心律的默认矢量,如例如在题为SYSTEMS AND METHODS FOR SENSING VECTOR SELECTION IN ANIMPLANTABLE MEDICAL DEVICE USING A POLYNOMIAL APPROACH的美国专利7,783,340以及题为SENSING VECTOR SELECTION IN A CARDIAC STIMULUS DEVICE WITH POSTURALASSESSMENT的美国专利8,483,843中所公开的,其公开内容通过引用并入本文。相关概念也被公开在美国PG专利公开号2017/0112399、2017/0113040、2017/0113050和2017/0113053中,其公开内容通过引用并入本文。在示例中,可以使用第二矢量选择和/或感测配置过程来确定给定设备将如何检测P波。
在其他示例中,可以选择特定于P波检测的滤波、增益或其他特性。例如,如果心室事件感测通道使用第一通带,则可以将P波感测通道通带设置为不同的通带。例如,R波或心室事件通带可以被设置在3-40Hz或9-40Hz的范围内,或其他设置。P波通带可以被设置为不同的范围,例如,0.5至20Hz。这种频带设置和选择可以部分取决于检查心室事件和/或心房事件中的一个或两个的捕获到的信号。如题为AUTOMATIC DETERMINATION AND SELECTIONOF FILTERING IN A CARDIAC RHYTHM MANAGEMENT DEVICE的美国PG专利公开号2017/0156617中讨论的方法,其公开内容通过引用并入本文,该方法可以用于选择一个或多个感测通道通带。在另一个示例中,可以改变通带直到期望的心房或心室特征的信号振幅开始下降为止,在此处可以设置通带的边缘或拐角处以实现目标的窄通带。因此,P波感测或心房感测配置可以使用与对应的R波感测或心室事件滤波器不同的频带。可替换地,可以设置单个通带以用于心房感测和心室感测中的每个,或者可以将不同的预设范围用于心房感测和心室感测中的每个。
因此,设置用于检测P波的感测配置可以包括设置检测窗口和/或选择滤波器配置中的任一个或两个。另外,在一些说明性示例中将检测P波的实际方式定义为感测配置的一部分。例如,可以通过将检测到的信号与固定或时变振幅阈值进行比较来检测P波。在另一示例中,可以通过将捕获到的信号片段与模板进行比较来检测P波,直到找到匹配或超时发生为止。当发现匹配时,可以声明进行P波检测;如果发生超时,则可以推断的是P波不存在或根本看不到。在一些示例中,不止一种识别P波的方法是可用的以进行使用,并且可以选择针对给定患者的最有效方法。例如,如果振幅阈值和P波检测模板匹配方法是可用的,则具有高度可变振幅信号的患者可以将他或她的设备配置为使用模板匹配方法而不是基于振幅的方法。
在一些示例中,在生成输出通信之前因而确认可能的P波。例如,P波的模板可以被定义并且用于通过将检测到的信号与模板进行比较来确认越过振幅阈值的检测到的信号是否实际上是P波。这种模板可以是静态的并且被存储在存储器中,其可以通过将第一时间上的P波与下一时间上的可能的P波进行比较来从一个搏动匹配到下一搏动,或者其可以是存储后的模板和完全动态模板的混合(如例如,通过将新检测到的P波平均到模板)。
在一些示例中,针对P波可用性,可以利用将用于同步LCP起搏的第二医疗设备来预先筛选患者。例如,很可能由于解剖结构变化或其他因素,一些患者将具有明确定义的P波,其为用于依赖的SICD或皮下心脏监视器提供准备好的基准以通过LCP促进CRT治疗。在其他患者中,P波可能难以一致地检测到。因此,可以执行预先筛选过程以作为临床内测试,或者通过让患者使用Holter监视器或通过植入皮下心脏监视器来确保容易一致地识别P波来执行。
以下示例还说明了这些优化,并给出了以下示例:如何将这种优化并入到具有LCP和第二可植入设备(诸如SICD或皮下心脏监视器)的组合系统中,以生成定时信息并将定时信息传送给LCP,以用于CRT的目的。然而,首先,图5A-5B、6和7将示出与检测到的心电信号有关的附加细节。
图5A示出了此时指示正在递送起搏治疗的另一说明性心脏信号。在170处示出了具有在172处示出的固有未起搏R波的迹线。在172处的该R波是在176处定义了P波检测窗口的时间段174的基准。在可替选方案中,与在180处指示的T波相关联的最大正斜率点可以用作再次定义了P波检测窗口176的持续时间182的基准。在一些示例中,这些交互可以通过声明心室事件用于生成心房事件的窗口检测的基准而被描述。
在图5A中,信号170的各种特征可以用作开始持续时间174/182的基准。图5B示出了信号的示例定时基准。信号200可以越过振幅阈值,在上升时在202处创建基准,或在向下返回时在204处创建另一基准。可代替地使用振幅峰值206。可替换地,可以使用拐点(inflection)208,其具有可用的正斜率拐点或负斜率拐点。在又一示例中,基准210可以依赖于超过限定阈值的曲线下的面积。为了定义P波检测窗口,可以使用这些或其他基准中的任何一个来建立时间上的点,从该点开始计数。基准可以应用于先前的P波、QRS波群、R波或T波。如果需要,可以如通过例如计算其中点或其他特征来使用ST分段。
返回到图5A,如果检测到P波,并且在一些示例中,在P波检测窗口176内确认P波,则在190处设置另一个基准,并且在P波到起搏延迟192之后,如在194处所示递送起搏治疗。可以通过递送起搏治疗的LCP或者通过提供用于递送治疗的命令的第二设备或指示P波发生的其他信息来计算延迟192。这种延迟192可以包含和/或容纳系统延时(由于分析数据、做出决定、传送数据、接收所传送的数据、分析接收到的数据以确定通信目的并生成治疗输出所需的时间而导致的延迟)。
为了说明的目的,起搏治疗194被示出为单相矩形脉冲,然而,这仅用于说明。起搏脉冲可以是单相或双相的,其中后者比前者更常见。通常起搏递送可以是恒定电流或恒定电压的,然而,可以使用更复杂的波形,诸如斜坡、指数和/或三相波形、或任何其他合适的波形。
在所示的示图中,起搏治疗192直接地或通过增加现有的神经信号来刺激足够的心肌以捕获心脏。结果,QRS波群发生致使搏动196。搏动196的QRS波群与搏动178的未起搏波群的简短视觉比较表明,通常情况下,196处的起搏搏动具有与内在搏动178不同的形状或形态,其具有更夸张的Q波以及不同形状的ST分段。如本技术中所理解的,可以注意到其他差异。如果需要,可以使用这些差异(或其他),以帮助使第二设备分析由LCP递送的CRT疗法的功效。
P波检测窗口中的检测可以采用几种形式。可以将所获得的心脏信号与P波检测阈值进行比较,该P波检测阈值可以例如基于已经检测到的先前P波。可以分析所获得的信号以确定是否出现与振幅组合的峰值斜率。例如,可以针对持续最小持续时间或最小振幅变化的选择形状的向上斜率而分析所获得的信号。
P波检测的两个示例在图5C和5D中示出。例如,如图5C所示,信号220包括222处的第一QRS波群。用于R波检测的检测轮廓在224处示出,并且可以是时变检测轮廓,其具有用于经过QRS波群的不应期、接着是用于经过T波的恒定阈值期、接着是衰减期。一旦信号220越过检测轮廓224,就声明新的心室事件检测,在这种情况下是相关联的R波226。检测轮廓224的各个部分的高度可以通过参考例如美国专利8,565,878中所讨论的一个或多个先前检测到的R波来计算。P波检测在230处在P波检测窗口中发生。在该示例中,当信号220越过P波检测阈值234时检测P波232。可以通过参考一个或多个先前检测到的P波的振幅来设置P波检测阈值234。可替换地,P波检测阈值234可以相对于检测轮廓224而缩放(诸如,检测轮廓224的20%至80%,或更多或更少)。然后可以使用P波检测来触发起搏脉冲(未示出),如本文件中其他地方所述。
图5D示出了另一示例。这里,心脏信号在240处示出,其中P波检测窗口在242处。窗口242中的信号如242'处所示被扩大。在244处示出了P波模板。为了检测P波,在接收到输入信号时进行一系列比较。一旦接收到足够的信号以执行形态比较,诸如通过面积差异、相关波形分析、小波变换或主成分分析,例如,就进行形态比较。随着更多信号进入,重复形态比较(其中数据在先进先出的基础上进入比较窗口),直到在248处找到匹配为止。然后匹配248是P波检测。
在更进一步的示例中,可以搜索P波检测窗口242以识别与可能的P波相关联的特定特征。例如,可以通过观察在P检测窗口期间是否出现超过阈值和具有最小路径长度的斜率来识别P波。关于图6讨论了用于确认信号是P波的其他方式。
图6示出了可以分析诸如P波的信号特征以用于确认目的的其他方式。在图6的示例中,P波检测窗口被定义为如260处所示。窗口260内的信号,如262处所示,包括峰值。在一个示例中,为了确认窗口260内的信号实际上是P波,可以对具有至少最小振幅264进行分析。在另一示例中,为了确认窗口260内的信号是P波,可以分析诸如上升和行进的组合的斜率特性,如266处所示,其中上升是振幅的变化量,并且行进是振幅变化发生的持续时间。
在又一个示例中,使用例如区域分析的差异、相关波形分析、小波变换或主成分分析的匹配可以用于将峰值262的形状与使用穿过窗口250的全部或一部分的其中的信号形状254的另一信号(诸如,250处所示的先前的P波检测窗口中的信号的形状)进行比较。逐搏动比较可以被称为动态比较,这是因为与新检测到的可能的P波相比较的形状将随着每个新的心动周期而变化。在另一示例中,可以使用诸如280处所示的所存储的模板。在该示例中,将形状262与由模板280定义的形状282进行比较。如果所存储的模板不随时间变化,则可以将其视为静态模板。混合模板可以被配置为通过对具有新检测到和经确认的P波的现有数据集进行平均,或者通过对几个先前的P波检测进行平均而随时间缓慢地变化。
图7示出了另一心脏信号以说明实施例的操作。在该示例中,心脏信号在300处示出。在310处示出第一心动周期,其包括固有P波、未起搏QRS波群、和拖尾的T波。在示例中,R波峰值在312处用作基准以启动以持续时间314到期的触发了P波检测窗口316的开始的定时器。在P波检测窗口316期间,SICD或皮下心脏监视器搜索P波。检测窗口316期间的操作可以包括选择特定的感测配置(感测矢量、滤波等)以观察诸如P波的心房事件。
在图7的示图中,心房感测在320处发生,在该示例中对应于P波的峰值振幅。在324处递送心室起搏刺激之前在322处开始延迟。在一个示例中,延迟322是经计算的延迟,其可以包括滞后期以允许由SICD或皮下心脏监视器进行分析、传输数据或命令到LCP、LCP的处理,以及包括一些有意的延迟(如果需要的话)以允许起搏脉冲324的适当定时来优化起搏效率。例如,在经静脉CRT系统中,AV延迟控制可以用于开始从P波或心房事件感测的适当延迟到心室起搏治疗的递送。在如本文所公开的系统中,AV延迟可以包括系统滞后以及有意延迟。
设备可以包括用于在时段322期间传送到LCP的特殊处理指令,以计算如果没有适当地接收或确认通信消息而发生了多少次重试。因此,如果由于某种原因(诸如外部干扰),LCP没有接收到来自SICD或皮下心脏监视器的初始通信,则随后的尝试可以指示已经发生了多少次重试以允许LCP适当地管理时段322。如果存在多次重试,如果需要,则可以抑制起搏脉冲324,以避免延长时段322而超过设置限制。不是依赖于重试的数量,LCP可能只是超时(timeout)。
继续该示例,320处的P波是新心动周期330的开始,在这种情况下其现在包括332处的具有相对于第一波群310的不同形态的起搏QRS波群。在该示例中,利用起搏捕获到的QRS波群332,设备可以改变其对基准点的选择以定义下一P波检测窗口,如342处所示。例如,在图7中,延迟340现在从324处的起搏递送开始而不是从R波开始。下一个心房事件或P波检测窗口在342处示出。再次,心房感测在P波的峰值处在344处发生,并且在延迟346(其可以再次包括系统滞后和有意延迟两者)之后,在348再次递送起搏治疗脉冲,致使在350处示出的起搏捕获到的QRS波群。根据系统设置,如果需要的话,346处的延迟可以与322处的延迟相同或不同。
图8、9和10A-10B示出了用于说明性示例的框图。在图8的示例中,使用可植入医疗设备的整体方法在400处示出。在402处初始化该设备或系统,之后在404处检测可治疗状况并且在406处递送治疗。对于诸如图1中所示的可植入心脏系统,治疗406可以包括递送针对心室纤维性颤动或多形快速性心律失常的治疗性电击,如410处所指示的。例如,SICD可以在410处递送除颤电击。可替换地,抗心动过速起搏(ATP)可以如412处所示被递送。例如,LCP可以响应于SICD的请求或命令而递送ATP或者自动递送ATP。如果需要的话,SICD也可以递送ATP。心动过缓起搏可以通过LCP或SICD中的一个或另一个来递送,其中LCP可能是优选的,这是因为SICD起搏递送可能引起患者的不适。在一些示例中,可以使用右心室LCP递送心动过缓起搏以治疗AV阻滞。最后,如本文详述的,可以在416处递送CRT起搏。
例如,响应于各种治疗410、412、414、416而可以如420处所指示执行对系统配置和其他设置的调整。例如,如果递送CRT起搏416但是无法生成融合搏动,则可以对P波检测和起搏递送之间的定时进行调整,或者对所递送的起搏治疗的持续时间、振幅或其他特性进行调整。在另一个示例中,如果递送心动过缓起搏414但是无法刺激心室收缩,则可以通过使用不同的振幅、脉冲宽度或形状来调整420所递送的治疗。
返回到初始化块,如上面和下面所讨论的,可以在初始化402期间配置多个设置。例如,感测配置(例如,用于心室事件检测和/或心房事件检测中的一个或两个的感测矢量和滤波)可以在初始化期间建立以优化对心室事件和/或心房事件的感测。通信操作也可以被初始化,例如,如题为COMMUNICATIONS IN A MEDICAL DEVICE SYSTEM WITH LINKQUALITY ASSESSMENT的美国专利申请号15/070,013和/或题为COMMUNICATIONS IN AMEDICAL DEVICE SYSTEM WITH TEMPORAL OPTIMIZATION的美国专利申请号15/058,412中所讨论的,其公开内容通过引用并入本文。
图9示出了关于感测参数的初始化的更详细讨论。在示例方法450中,如452处所指示的,获得初始化数据,并且如470处所指示的,选择一个或多个感测矢量。接下来,如480处所指示的,设置检测参数,诸如用于检测P波或心房事件的参数(P-检测参数)。一般来说,步骤452、470和480集中于SICD或皮下心脏监视器的操作,以用于如图1所示的系统,其具有皮下定位设备以及LCP两者。然而,LCP还可以被设置用于感测配置以优化其检测源自LCP所位于的心脏的任何腔室中的信号和/或滤除噪声信号的能力。
在452处获得初始化数据的步骤可以包括如图9左侧所指示的各种子过程。例如,如454处所指示的,可以在456处在一个或多个感测矢量中或者用一个或多个不同的感测配置(影响例如滤波和/或放大参数,可能与矢量选择参数进行组合)来检测多个单独的心动周期。可以通过例如对来自每个周期的不同检测数据元素进行分箱(binning)来分析458对心动周期的各个检测,如题为SYSTEMS AND METHODS FOR SENSING VECTOR SELECTION INAN IMPLANTABLE MEDICAL DEVICE USING APOLYNOMIAL APPROACH的美国专利7,783,340中所讨论的。作为在460处示出的替换方案,如462处所指示检测一组心动周期,并且如464处所指示生成复合信号。例如,在题为SIGNAL QUALITY MONITORING FOR MULTIPLE SENSEVECTORS IN CARDIAC DEVICES的美国PG专利公开号2017/0113053(其公开内容通过引用并入本文)中讨论使用复合信号来建立感测矢量质量度量。
接下来,在块470中,选择用于心室(目标,例如,R波、QRS波群和/或T波)和/或心房事件检测(目标,例如,P波)的感测矢量配置。矢量配置可以包括选择要使用的电极的组合、要一起使用的两个或更多个矢量的组合、和/或设置滤波、消除、难治(refractory)、放大或其他参数。可以使用各种矢量选择方法,包括上面从其他专利或专利申请中引用的那些方法,以及本文讨论的那些方法。例如,如472处所指示的,可以使用矢量配置的一致性来选择给定矢量。例如,一致性472可以意味着在给定的矢量配置中,所选择的心脏事件(P波、R波或T波或QRS波群)在形状、振幅和/或定时上是一致的。可替换地或与一致性组合地,也可以考虑信号的绝对和/或相对于噪声的强度474。
在一些示例中,一旦设置了矢量配置,就如480处所指示设置用于识别P波的参数。在替代方案中,如490处的线所指示的,可以绕过感测配置步骤,并且在480处设置P-检测参数。例如,在一些实施例中,仅在连接到临床医师编程器时可以执行块470以确保获得适当的信号和/或不修改与已知的患者历史相反的感测配置,同时块452和480可以由独立于编程器干预的设备执行。在一些示例中,另一方面,可以省略块480,其中执行感测矢量设置并且由设备使用任何合适的P波检测方法,而不必在480处执行单独的优化。
块480要求设置一个或多个参数以优化P波检测。在一些示例中,这可以包括:在482处从触发P波检测所处的位置选择一个或多个基准点、设置用于检测P波的窗口484,在尝试检测P-波时选择要查找的特征486、或者在488处选择用于P波确认的模板。块482、484、486、488中的任何一个可以以各种组合使用,或者在一些示例中,可以单独使用。
例如,482处的基准点选择可以用于选择开始消隐期(在此期间不能检测到P波)的特征(无论是心房或心室(诸如R波、T波、先前的P波),还是其他生理,诸如心音、血压信号或其他定时参考点诸如起搏脉冲的递送),例如以经过T波,并且在消隐期期满时启用P波检测。可替换地,基准点482可以用于触发对P波的分析窗口的启动。窗口484可以如上面图5A、6和7中所示使用,例如,通过当P波通常出现时相对于所选择的基准点确定并然后设置持续时间的窗口等于或长于允许P波检测的P波而使用。窗口可以是例如大约50到400毫秒。在另一个示例中,窗口可以是大约100到大约200毫秒。可以使用其他持续时间。
用于识别P波的哪些特征是另一个元素,如486处所指示的。例如,可以通过具有某范围的振幅(诸如,大于阈值)来识别P波。阈值可以通过例如将其设置为先前P波的某个百分比(50%至90%,或更多或更少)或者多个先前P波的平均值,或者与通常或特定于给定患者的典型P波有关的存储信息来适应当前患者状况。其他特征可以包括最大或最小斜率振幅或长度。在示例中,可以通过检测信号在预定义的斜率参数内在特定方向上移动了至少预定振幅或时间段来识别P波。因此,例如,信号可以具有作为P波特性的向上斜率,在至少选择持续时间内不像R波那么陡,但比T波更陡,以用于避免噪声检测。可以通过使用所获得信号的一阶或二阶导数来进行斜率分析。在块486处可以替代地使用其他特征。
模板488也可以独立于其他项目使用以检测P波。例如,可以在连续或半连续的基础上将模板与接收到的数据进行比较,并且当找到匹配时,可以声明P波(参见上面的图5d)。模板可以是先前信号的平均复合物,或者可以简单地是先前的P波,或者可以以任何其他合适的方式进行构造。输入信号本身可以是具有例如P、Q、R和S信号(以及T波(如果复合物被如此配置的话))的过个心动周期的信号平均复合物。
在示例中,在使用484定义的窗口期间,可以将模板与输入数据流进行比较以识别匹配。在其他示例中,模板488可以用于确认检测到的可能的P波,诸如在P波检测窗口期间越过限定的振幅阈值的信号。如果模板488匹配可能的P波,则确认P波检测,或可替换地,如果与模板488不匹配,则可以丢弃检测,这是因为不是P波。
图10A-10B示出了两种感测配置方法的概要表征。如图10A所示,在500处捕获数据。接下来,通过例如设置感测矢量和滤波、存储用于区分正常和异常心脏活动的形态信息(本技术中已知的模板、小波变换等)等来设置VT/VF感测502配置和参数。最后,在504处设置用于心动过缓治疗和/或CRT治疗控制的感测配置。块504可以包括配置感测矢量或组合、滤波等,以及模板选择、窗口设置和基准评估,或者上面和下面都提到的其他步骤。
图10B示出了另一种表征。这里,在510处获得数据,然后在512处设置心室感测参数。可以优化心室感测512参数以检测R波和/或VT/VF信号,包括滤波和矢量选择或组合,以及阈值设置和/或模板形成。在514处设置心房感测参数,并且可以包括优化以检测P波或其他心房事件,包括滤波、加窗和矢量选择或组合,以及阈值设置和/或模板形成。
图11以方框流程图的形式示出了两个协作设备的操作。第一设备执行如600处所示的操作,而第二设备执行如620处所示的操作。设备之间的通信在610、612处示出,但应该理解的是,在设备操作期间也可以进行附加的来回通信。
在第一时间点处,每个设备感测心脏活动,如602、622处所示。例如,在块602期间,设备1(其可以是SICD或皮下心脏监视设备)可以执行感测心室事件和/或心房事件,诸如观察R波、T波或P波。设备2(其可以是LCP)可以执行或可以不执行感测。在一些示例中,设备2可以省略感测并且可以代替地简单依赖于设备1以用于治疗方向。在其他示例中,两个设备都感测心脏(或其他)活动。例如,在块622中,设备2可以观察是否发生了心室收缩外事件,诸如心室早发性收缩(PVC),或者在检测到心房事件之前是否心室以其他方式“搏动”。(参见下面的图18,以用于这种异常处理)。
在604处,设备1检测到触发。触发可以是例如心房事件,诸如P波。例如,可以在P波检测窗口期间检测P波,或者可以通过将接收到的信号与模板进行比较来检测P波。如果需要,则可以通过使用检测方法(例如,在P波窗口期间与振幅进行比较)和确认方法(将可能的P波信号与模板进行比较)来检测和确认P波。
然后,设备1进行通信输出,如606处所示,向设备2发出通信,然后在设备2处接收该通信。通信可以命令或请求治疗递送,或者可以指示已经检测到P波。例如,在主-从关系中,设备2可以接收用于起搏治疗的命令并且简单地通过生成起搏输出来响应。在其他交互中,设备2可以接收对治疗递送的请求并继续递送所请求的治疗,除非在收到请求之前或之后出现异常。在又一次交互中,设备2可以接收设备1已经观察到P波的指示,并且设备2然后可以确定起搏或其他治疗是否合适。
在624处接收到通信之后,在所示的示例中,在626处设备2递送治疗。两个设备中的任一个或两个可以可选地确认治疗在608和628处有效。该确认可以在设备之间传送,如612处所指示的。例如,设备1可以通过使用例如起搏搏动模板来观察治疗递送后的心脏信号的形态而确认治疗是有效的。设备2可以通过观察形态或通过任何其他合适的方式来确认治疗是有效的。可替换地,可以省略通信612。例如,设备1可以在检测到对治疗626的诱发响应之后或者在检测到治疗626之后重新开始其感测周期;设备2可以在递送治疗626之后重新开始其感测周期。
虽然图11中仅表示了两个设备,但可能涉及附加设备。例如,第三设备可以是类似于设备2起作用的LCP。例如,第一LCP可以具有右心室位置并且第二LCP可以具有左心室位置,允许双心室起搏被递送,其中两个LCP设备在设备1检测到心房事件时生成依赖于定时信息的治疗输出。如果包括两个LCP设备,则每个LCP设备可以被单独编程以将治疗626从在604处检测到的触发延迟,以实现期望的再同步特性。可以使用图12A-12B所示的方法部分地解决涉及单个或多个LCP设备的这种定时。
图12A-12B示出了处理跨设备定时的不同方式。在该示例中,示出了LCP的操作,其中LCP在650处接收通信。该通信包括与SICD识别治疗触发所处的时间相关联的时间戳,该时间戳从块652中的通信中提取。时间戳可以是如654所指示的相对时间戳。相对时间戳可以基于系统事件,诸如先前通信的时间点,或者由SICD检测到的先前治疗递送的时间点。例如,SICD能够确定LCP何时递送起搏脉冲,并且可以相对于LCP先前的起搏脉冲而传送检测到的触发的定时;以这种方式,LCP不需要将其时钟与SICD同步,并且取而代之的是简单跟踪其何时最后一次递送治疗。可替换地,时间戳可以基于同步时钟信号,如656处所指示的,其中设备(LCP或SICD)中的一个包括与每个设备同步的系统时钟。使用时间戳,LCP确定相对于触发事件何时应该递送治疗,如660处所指示的。
图12B示出了一种稍微简单的方法。在680处接收通信,并且基于在682处递送治疗,而不依赖于通信的时间戳。这里,LCP确定何时接收到通信并基于通信时间确定何时递送治疗。图12B的方法部分地依赖于从触发事件到通信的时间是可预测和可重复的假设。如本领域技术人员所知,通信重试可以在发出通信但未被预期接收者确认时发生。因此,重试可能会延迟图12B的方法中的治疗。为了促进精确度,从SICD提供的通信可以指示它是否是响应于给定触发的第一通信,或者它是否是重试,使得LCP可以根据是否已经存在一个或多个通信重试来调整其定时。
图13-18以方框流程图的格式示出了两个协作设备的操作。如图11所指出的,可能不仅仅是这些图中表示的两个设备,其中附加的LCP设备在一些示例中与图中的“设备2”类似地操作。
图13示出了在700处的设备1(其可以是SICD或皮下心脏监视器)和在720处的设备2(其可以是LCP)的操作。在该示例中,每个设备感测所获得的信号以寻找检测到一个或多个预定义事件。设备1检测触发事件,诸如心房事件或P波,如704处所指示的。然而,设备2还检测抑制事件,如724处所指示的。抑制事件可以是例如QRS波群或R波或PVC。在724处的这种检测可以通过例如将接收到的信号与以足够高的振幅定义以经过典型的P波和/或T波的阈值进行比较而发生。在724处抑制剂的存在致使设备2拒绝治疗,如该示例中的726处所示。因此,当设备1响应于在704处检测到触发而在706处进行通信输出时,设备2可以通过忽略它或者通过向设备1提供响应以指示由于已经检测到抑制剂而不会递送治疗来响应710处的通信。如前,两个设备可以在708、728处确认状态,在它们之间有或没有通信712。
图14示出了具有设备1和设备2的操作的另一示例,设备1可以是在750处示出的SICD或皮下心脏监视器,并且设备2可以是在770处的LCP。这里,设备1在752处将其感测应用于触发,然而,在754处没有检测到触发。设备2也在772处进行感测,但是在没有检测到抑制事件并且没有从设备1接收到指示应该递送治疗的通信的情况下遭遇超时。在一些示例中,这种情况可以完全抑制治疗。然而,在该示例中,设备2响应于774处的超时而在776处递送治疗。例如,如果相关的逸搏间期对于既依赖于起搏并接收CRT的患者而言期满,则可以发生超时774。此外,设备可以在756、778处确认状态,在它们之间在760处有或没有通信。
图15示出了具有设备1和设备2的操作的另一示例,设备1可以是在800处示出的SICD或皮下心脏监视器,并且设备2可以是在820处的LCP。设备1和设备2中的每一个分别在802、822处应用感测参数。设备1在804处检测到触发并且在806处通信输出到设备2,命令或请求治疗、或者仅指示触发804的存在。设备2在824处接收通信810,并且然后响应于触发(并且在相对于触发的经确定的延迟之后)而递送治疗826。然而,在该示例中,设备1在806处的通信输出之后继续感测,并且确定治疗未能捕获心脏。这种失败可以通过以下来确定:响应于治疗825而不存在R波或QRS波群,或者分析确实发生的R波或QRS波群并且确定它确实类似于所捕获的搏动(通过例如确定捕获模板不匹配),或者它发生在指示没有捕获的时间处(即,响应性收缩可能发生得太晚或太早而不能作为对刺激的响应)。
在图15的示例中,治疗失败808然后被传送到设备2,其在828处修改治疗。治疗修改828可以包括:例如改变治疗振幅、脉冲宽度或其他形状/能量特性;通过增加或减少来自触发的延迟而改变对治疗时间的定时;改变治疗极性、极性类型或电极配置;或通过改变一个或多个其他合适的治疗特性。特定治疗修改828可以由设备1或设备2中的任一个确定。在该示例中,在未捕获之后,设备返回到感测。在该示例中,设备2可以存储新的起搏参数以供在下一次迭代中使用。
图16示出了图15的替代方案。设备1(其可以是SICD或皮下心脏监视器)的操作在850处示出。设备2(其可以是LCP)的操作在880处示出。设备1和设备2中的每一个分别在852、882处应用感测参数。设备1在854处检测触发并且在856处通信输出到设备2,命令或请求治疗、或者仅指示触发854的存在。设备2在884处接收通信870,并然后响应于触发(并且在相对于触发的经确定延迟之后)而递送治疗886。
然而,在图16的示例中,设备1在856处的通信输出之后继续感测,并且确定治疗未能捕获心脏,如858所指示的。这里,将确定的是对治疗886没有响应并且心脏还没有进行收缩。在872处发出通信以响应于在858处发现治疗失败,并且通过设备2在888处重试治疗。可以进行多次重试,并且可以利用改变后的参数(包括增加的振幅和/或脉冲宽度;改变极性、极性类型或电极配置,或通过改变一个或多个其他合适的治疗特性)而发生治疗重试。一旦通过捕获或内在地发生搏动,设备就确认在860、890处发生心脏搏动,在它们之间有或没有通信874。在该示例中,设备2可以存储新的起搏参数以供下一次迭代使用。在许多CRT患者中,图16的情况可能不太需要;取而代之的是,那些依赖起搏器的人,例如具有AV阻滞,可以通过使用右心室放置的LCP而受益(见物品40,图1)。
图17示出了另一个说明性示例。设备1(其可以是SICD或皮下心脏监视器)的操作在900处示出。设备2(其可以是LCP)的操作在920处示出。设备1和设备2中的每一个在902、922处分别应用感测参数。设备1在904处检测抑制剂,其可以是例如QRS波群、R波或PVC。在一些示例中,设备1可以将抑制剂904检测为房性期前收缩(PAC)。响应于抑制剂,如906处所示,设备1可以生成到设备2的通信910。设备2在924处接收通信,并且如926处所指示抑制治疗。两个设备可以在908、928处确认状态,在它们之间有或没有通信912。例如,如果设备2被配置为在没有抑制命令的情况下以给定间隔递送治疗,则可以出现图17的场景。
对于图13和17中的每一个,与在起搏捕获到的搏动之后使用的参数相比,特殊参数可以在识别用于随后周期的抑制事件之后被应用。例如,在抑制事件之后,可以修改用于感测的参数以针对超时的起始点使用不同的时段和基准。简要地参考图7,例如,以下可以根据是否发生内在搏动(在302处示出)或起搏搏动(在332处示出)而改变:
-第一延迟时段314可以与第二延迟时段340不同;
-第一P波检测窗口316可以使用与第二P波检测窗口342不同的持续时间、滤波或检测参数(诸如振幅或斜率阈值或P波模板);
-第一延迟322可以与起搏治疗递送之前的第二延迟346不同;和/或
-第一起搏治疗324可以具有与第二起搏治疗348不同的振幅、极性、极性类型、脉冲宽度或其他参数。
如果发生PVC或PAC而不是QRS波群,则第三组(或更多组)参数可以应用于这些变量中的任一个。例如,如果基准或检测窗口的某个元素遭遇异常事件,则可以定义附加的例外规则。例如,如果使用T波峰值作为基准来对P波检测窗口进行定时,则可以要求T波峰值来证明某些特性(诸如最小振幅或特定极性)被认为适合作为基准。如果基准事件未以预期方式发生,则可以应用其他例外规则。
图18示出了植入前的过程流程。如950处所指示的,首先识别具有适当CRT适应症的患者。这种适应症在本技术中是公知的,任何适应症可以包括例如宽QRS波群、左束支传导阻滞、纽约心脏协会功能分类以及关于合并症的信息。如952处所指示的,患者可以对SICD捕获的心脏信号的充分性进行预筛选。步骤952可以例如使用以下中所讨论的工具、度量和方法:题为PATIENT SCREENING TOOLS FOR IMPLANTABLE CARDIAC STIMULUS SYSTEMS的美国专利8,079,959和/或题为AUTOMATED SCREENING METHODS AND APPARATUSES FORIMPLANTABLE MEDICAL DEVICES的美国专利申请序列号15/001,976,其公开内容通过引用并入本文。例如,可以观察到R波的大小和/或一致性和/或心脏信号的信噪比,或者可以在植入之前,通过应用该设备一旦被植入就会使用在植入之前获得的信号的算法而确定可植入设备算法正确分析所获得的心脏信号的能力。然后可以相对于P波重复类似的过程,如954处所指示的。如果两个预筛选都通过,则患者可以接收SICD和LCP的组合,如956处所指示的。如果预筛选952、954中的任一个失败,则患者可以被植入有经静脉CRT系统,如958处所指示的。
可以出现其他组合;例如,患者可以通过SICD筛查,并且然后可以经静脉接收与SICD配对的CRT-P设备。在这种系统中,CRT-P设备和SICD可以根据需要彼此通信,在一些示例中,包括用于使用SICD来帮助确定CRT-P是否将在心脏的一个或多个腔室中提供起搏治疗以及何时将在心脏的一个或多个腔室中提供起搏治疗的上述方法。
以下是许多说明性示例,其指示了可以在本发明的上下文中定义各种装置的方式。
第一说明性示例可以采取可植入设备系统的形式,该可植入设备系统包括第一医疗设备(14,40)和第二医疗设备(16),第一医疗设备(14,40)包括用于将起搏治疗递送到患者心脏的起搏装置,第二医疗设备(16)包括用于感测患者心脏的活动的感测装置。起搏装置可以包括控制输出数模转换器(使用电压或电流控制),其被配置为经由可植入设备的输出电路递送输出电流或电压(诸如以图3中的脉冲发生器模块104所示),其用于耦合到电极114、116和/或118中的一个或多个。感测装置可以包括处理电路,处理电路包括例如滤波、放大和根据需要的模数转换电路52,其经由输入/输出电路58耦合到一个或多个电极,诸如在64、66处和/或引线70上的72处所示的罐/外壳上的电极,所有这些电极都在图2中示出。
此外,在第一说明性示例中,第一医疗设备还包括用于至少接收来自至少第二医疗设备的通信的第一通信装置,并且第二医疗设备包括用于至少向至少第一医疗设备发出通信的第二通信装置。第一通信装置可以包括放大、调制、解调和/或处理电路,其构成了可以使用天线和/或电极114、116和/或118进行辐射或传导通信的通信模块102,所有都在图3中示出。第二通信装置可以包括放大、调制、解调和/或处理电路,其构成了继而可以使用天线74和/或电极64、66和/或72中的一个或多个进行通信的通信块62,全部都在图2中示出。
此外,在第一说明性示例中,第二医疗设备包括用于使用感测装置来检测患者心脏中的心房事件并且响应于此而向第一医疗设备发出通信的心房事件装置。这种心房事件装置可以采取存储在存储器54中的用于由处理块52进行操作的指令集的形式,处理块52可以包括:微控制器;微处理器;状态机或其他控制、逻辑和/或处理电路,所有都在图2中示出。用于心房事件装置的指令集可以包括用于感测602、检测触发604和通信输出606的指令,如图11所示,以及图13-17的类似操作块(这里,第一说明性示例中的第二医疗设备可以在图11和13-17的任何一个中作为“设备1”而进行操作)。
最后,在第一说明性示例中,第一医疗设备包括治疗装置,以用于响应于通信装置接收到由第二医疗设备发出的通信而使用起搏装置将治疗递送到患者的心脏。治疗装置可以采取操作指令的形式,以用于由可操作地耦合到通信模块102和脉冲发生器模块104的如110处所示的处理模块执行,所有都如图3所示。用于治疗装置的操作指令可以包括用于如图11所示的接收通信624和递送治疗626的指令,以及图13-17的类似操作块(这里,第一说明性示例中的第一医疗设备可以在图11和13-17的任何一个中作为“设备2”进行操作)。
第二说明性示例采取如第一说明性示例中的系统的形式,其中第二医疗设备包括用于初始化第二医疗设备心房事件装置的初始化装置,其包括:用于检测患者的至少第一心动周期和第二心动周期的检测装置;和用于建立检测心房事件的窗口的窗口装置;其中,心房事件装置被配置为在用于检测心房事件的窗口期间观察患者的心脏信号,以便检测心房事件。在该第二说明性示例中,初始化装置可以采取存储在存储器54中的用于由处理块52进行操作的指令集的形式,处理块52可以包括:微控制器;微处理器;状态机或其他控制、逻辑和/或处理电路,在该指令中,处理块52可以控制和/或访问I/O块58以使用系统电极64、66和/或72,所有都在图2中示出。用于初始化装置的这种指令可以操作以如图9所示来执行,使用如由454和460中的一个或两个所示进行操作的检测装置指令以获得数据(如562处所指示的),并然后设置参数,包括例如484处所指示的P波检测的窗口。图10A-10B示出了初始化装置指令集的附加版本,包括获得数据和设置brady/CRT感测参数504和/或心房感测参数514。图5A、5C和5D每个都示出了使用这种窗口176(图5A)、230(图5C)和242(图5D)的说明性方法。
在与第二说明性示例相关的附加子示例中,检测装置可以被配置为使用至少第一心动周期和第二心动周期来计算复合心动周期数据集;并且窗口装置可以被配置为使用复合心动周期数据集建立用于检测心房事件的窗口,诸如图9中的460、462、464处所示。在又一个子示例中,窗口装置被配置为使用以下因素中的至少一个来设置用于检测的窗口的定时信息:由感测装置检测到的心室事件的特征;或由第一医疗设备输出的治疗的出现;图7说明性地示出了使用心室事件(R波312)作为这样的基准。此外,这些子示例可以体现在用于由处理块52和包括图2中的I/O块58的相关联电路进行操作的操作指令中。
在第三说明性示例中,第二说明性示例的初始化装置包括用于确定心房事件的特性的事件表征装置,该特性包括以下中的至少一个:振幅;与一个或多个先前心室事件进行比较的相对振幅;与心动周期期间的平均振幅进行比较的相对振幅;或最大斜率或最小斜率;其中心房事件装置被配置为使用心房事件的确定特性以便检测心房事件。可以根据用于由处理块52(图2)操作的操作指令来选择和使用这种特征486(图9),以执行至少如图9所示的方法。
在另一说明性示例中,第一或第二说明性示例的心房事件装置包括比较装置,其用于确定在用于检测心房事件的窗口期间捕获到的信号是否与所存储的心房事件模板或动态心房事件模板匹配,并且使用比较结果推断在用于检测的窗口中是否发生心房事件。这种比较装置可以体现在被配置为执行如图5D所示的执行指令的处理块52(图2)中。
在说明性示例中,第一、第二或第三说明性示例中的任一个的第二医疗设备包括被配置用于感测心脏信号的多个电极,并且第二医疗设备包括矢量选择装置,其包括:心室信号矢量装置,其被配置为分析来自由多个电极限定的多个感测矢量的信号并选择第一感测配置以用于检测心室事件;和心房信号矢量装置,其被配置为分析来自由多个电极限定的多个感测矢量的信号并选择第二感测配置以用于检测心房事件。矢量选择装置可以采取存储在存储器54中的用于由处理块52进行操作的指令集的形式,处理块52可以包括:微控制器,微处理器,状态机或其他控制、逻辑和/或处理电路,I/O块58中的控制开关,全部都在图2中示出,其中指令集被配置为执行如图10B所示的方法。可以设计这样的示例,使得心房事件装置被配置为使用第二感测配置确定用于感测心房事件的一个或多个参数,和/或使得心房事件装置被配置为建立用于心房事件的模板以用于确定使用第二感测配置所捕获的信号是否是预定类型的心房事件。
第一至第三说明性示例中的任一个可以选择性地操作以治疗心动过缓、和/或改善心脏同步。此外,这种说明性示例可以被配置为允许第二医疗设备使用通信装置指示其已经检测到心房事件,并且其中治疗装置被配置为确定相对于心房事件的定时而要何时递送治疗。另外,在一些其他示例中,第二医疗设备具有第二通信装置,该第二通信装置具有被配置为命令在特定时间处由第一医疗设备递送治疗的操作指令。
这些说明性示例可以包括一种系统,其中第一医疗设备是无引线心脏起搏器,并且第二医疗设备是可植入心脏监视器。可替换地,这些说明性示例可以包括一种系统,其中第一医疗设备是无引线心脏起搏器,并且第二医疗设备是皮下可植入除颤器。
这些非限制性示例中的每个可以独立存在,或者可以以与其他示例中的一个或多个进行各种排列或组合的方式进行组合。
以上详细描述包括对附图的参考,附图形成了详细描述的一部分。附图通过说明的方式示出了可以实践本发明的具体实施例。这些实施例在本文中也称为“示例”。这种示例可以包括除了所示出或描述的那些之外的元件。然而,本发明人还考虑了仅提供所示或所述的那些元件的示例。此外,本发明人还考虑了使用关于本文所示或所述的特定示例(或其一个或多个方面)或关于其他示例(或其一个或多个方面)所示或所述的那些元件的任何组合或排列的示例(或其一个或多个方面)。
如果本文件与通过引用并入的任何文件之间的用法不一致,则以本文件中的用法为准。
在该文件中,如在专利文件中常见的,术语“一”或“一个”用于包括一个或多于一个,独立于“至少一个”或“一个或多个”的任何其他实例或用法。此外,在以下权利要求中,术语”第一”、“第二”、和“第三”等仅用作标签,并不旨在强加过程中的特定步骤顺序,或对他们对象的任何数字要求。在权利要求中预期步骤的特定顺序的情况下,将使用词语“之前”或“之后”。
本文描述的方法示例可以至少部分地是机器或计算机实现的。一些示例可以包括编码有指令的计算机可读介质或机器可读介质,所述指令可操作以配置电子设备来执行如以上示例中所述的方法。这种方法的实现可以包括代码,诸如微代码、汇编语言代码、更高级语言代码等。这种代码可以包括用于执行各种方法的计算机可读指令。代码可以形成计算机程序产品的一部分。此外,在示例中,代码可以诸如在执行期间或在其他时间有形地存储在一个或多个易失性、非暂时性或非易失性有形的计算机可读介质上。这些有形计算机可读介质的示例可以包括但不限于硬盘、可移动磁盘或光盘、磁带盒、存储卡或棒、随机存取存储器(RAM)、只读存储器(ROM)等。
以上描述旨在是说明性的而非限制性的。例如,上述示例(或其一个或多个方面)可以彼此组合使用。在回看以上描述时,诸如本领域普通技术人员可以使用其他实施例。
提供摘要以符合37C.F.R.§1.72(b),以允许读者快速确定技术公开的性质。其在具有以下理解的情况下进行提交:其将不用于解释或限制权利要求的范围或含义。
此外,在以上详细描述中,各种特征可以聚集在一起以简化本公开。这不应被解释为未要求的公开特征对于任何权利要求是必不可少的意图。相反,发明主题可以在于少于特定公开实施例的所有特征。因此,以下权利要求作为示例或实施例在此被并入到详细描述中,其中每个权利要求独立作为单独的实施例,并且预期的是这种实施例可以以各种组合或排列而彼此组合。应该参考所附权利要求以及这种权利要求所赋予的等同物的全部范围来确定本发明的范围。
Claims (15)
1.一种可植入设备系统,包括:
第一医疗设备,该第一医疗设备包括用于向患者的心脏递送起搏治疗的起搏装置;和
第二医疗设备,该第二医疗设备包括用于感测所述患者的心脏活动的感测装置;
其中,所述第一医疗设备还包括用于至少接收来自至少所述第二医疗设备的通信的第一通信装置,并且所述第二医疗设备包括用于至少向至少所述第一医疗设备发出通信的第二通信装置;
其中,所述第二医疗设备包括心房事件装置,该心房事件装置用于使用所述感测装置来检测所述患者的心脏中的心房事件,并且响应于此而向所述第一医疗设备发出通信;
其中,所述第一医疗设备包括治疗装置,该治疗装置用于响应于所述第一通信装置接收到由所述第二医疗设备发出的通信,而使用所述起搏装置向所述患者的心脏递送治疗。
2.根据权利要求1所述的系统,其中,所述第二医疗设备包括用于使第二医疗设备的心房事件装置初始化的初始化装置,所述初始化装置包括:
用于检测所述患者的至少第一心动周期和第二心动周期的检测装置;和
用于建立检测所述心房事件的窗口的窗口装置;
其中,所述心房事件装置被配置为在用于检测所述心房事件的窗口期间观察所述患者的心脏信号,以便检测所述心房事件。
3.根据权利要求2所述的系统,其中:
所述检测装置被配置为使用所述至少第一心动周期和第二心动周期计算复合心动周期数据集;并且
所述窗口装置被配置为使用所述复合心动周期数据集来建立用于检测所述心房事件的窗口。
4.根据权利要求2或3中任一项所述的系统,其中,所述窗口装置被配置为使用以下因素中的至少一个来设置用于检测的窗口的定时信息:
由所述感测装置检测到的心室事件的特征;或者
由所述第一医疗设备输出的治疗的发生。
5.根据权利要求2至4中任一项所述的系统,其中,所述初始化装置包括用于确定所述心房事件的特性的事件表征装置,特性包括以下中的至少一个:
振幅;
与一个或多个先前心室事件进行比较的相对振幅;
与心动周期期间的平均振幅进行比较的相对振幅;或者
最大斜率或最小斜率;
其中,所述心房事件装置被配置为使用已确定的所述心房事件的特性以便检测所述心房事件。
6.根据权利要求2至4中任一项所述的系统,其中,所述心房事件装置包括比较装置,该比较装置用于确定在用于检测所述心房事件的窗口期间捕获到的信号是否与所存储的心房事件模板或动态心房事件模板匹配,并且使用比较结果来推断在用于检测的窗口中是否发生了心房事件。
7.根据权利要求1至6中任一项所述的系统,其中,所述第二医疗设备包括被配置用于感测心脏信号的多个电极,并且所述第二医疗设备包括矢量选择装置,该矢量选择装置包括:
心室信号矢量装置,其被配置为分析来自由所述多个电极限定的多个感测矢量的信号,并选择用于检测心室事件的第一感测配置;和
心房信号矢量装置,其被配置为分析来自由所述多个电极限定的多个感测矢量的信号,并选择用于检测心房事件的第二感测配置。
8.根据权利要求7所述的系统,其中,所述心房事件装置被配置为使用所述第二感测配置来确定用于感测心房事件的一个或多个参数。
9.根据权利要求7所述的系统,其中,所述心房事件装置被配置为建立用于心房事件的模板,以用于确定使用所述第二感测配置捕获到的信号是否是预定类型的心房事件。
10.根据权利要求1至9中任一项所述的系统,其中,所述治疗被配置为治疗心动过缓。
11.根据权利要求1至9中任一项所述的系统,其中,所述治疗被配置为改善心脏同步。
12.根据权利要求11所述的系统,其中,所述第二通信装置被配置为指示所述第二医疗设备已经检测到心房事件,并且其中,所述治疗装置被配置为确定相对于所述心房事件的定时而要何时递送治疗。
13.根据权利要求11所述的系统,其中,所述第二通信装置被配置为在特定时间处命令所述第一医疗设备递送治疗。
14.根据权利要求1至13中任一项所述的系统,其中,所述第一医疗设备是无引线心脏起搏器,并且所述第二医疗设备是可植入心脏监视器。
15.根据权利要求1至13中任一项所述的系统,其中,所述第一医疗设备是无引线心脏起搏器,并且所述第二医疗设备是皮下可植入除颤器。
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- 2017-06-26 WO PCT/US2017/039312 patent/WO2018005373A1/en unknown
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US10512784B2 (en) | 2019-12-24 |
CN109414582B (zh) | 2022-10-28 |
US20170368360A1 (en) | 2017-12-28 |
JP6764956B2 (ja) | 2020-10-07 |
WO2018005373A1 (en) | 2018-01-04 |
EP3474945B1 (en) | 2022-12-28 |
US11497921B2 (en) | 2022-11-15 |
US20200094063A1 (en) | 2020-03-26 |
EP3474945A1 (en) | 2019-05-01 |
JP2019519326A (ja) | 2019-07-11 |
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