CN109475743A - 在无引线心脏起搏器系统中利用心房收缩定时基准的系统 - Google Patents
在无引线心脏起搏器系统中利用心房收缩定时基准的系统 Download PDFInfo
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Abstract
无引线心脏起搏器(LCP)被配置为感测心脏活动并且使患者的心脏起搏并且在患者心脏的心室内可以是可任意放置的。LCP可以包括外壳、相对于外壳固定并且间隔开的第一电极和第二电极。控制器被设置在外壳内并且可操作地耦合到第一电极和第二电极,使得控制器能够经由第一电极和第二电极接收心脏的心电信号。LCP可以包括压力传感器和/或加速度计。控制器可以至少部分地基于以下中的两个或更多个信号来确定心房收缩定时基准:来自压力传感器的信号、来自加速度计的信号以及心电信号。
Description
相关申请的交叉引用
本申请要求2016年7月20日提交的美国临时专利申请序列号62/364,624的权益,其公开内容通过引用并入本文。
技术领域
本公开通常涉及可植入医疗装置,并且更特别地,涉及使用无引线心脏起搏器来对患者心脏进行监视、起搏和/或除颤的系统。
背景技术
目前,可植入医疗装置通常用于监视患者和/或向患者递送治疗。例如并且在一些情况下,起搏装置用于治疗患有可能导致心脏向患者身体递送足够量血液的能力降低的各种心脏病的患者。这种心脏病可能导致缓慢的、快速的、不规则的和/或低效的心脏收缩。为了帮助减轻这些病症中的一些,可以将各种医疗装置(例如,起搏器、除颤器等)植入在患者体内。这种装置可以监视并且在一些情况下向心脏提供电刺激(例如起搏、除颤等)以帮助心脏以更正常的、高效的和/或安全的方式操作。在一些情况下,感测和/或起搏心脏的两个或更多个腔室是有益的,诸如以提供心脏再同步治疗(CRT)。
发明内容
本公开通常涉及可植入医疗装置,并且更特别地,涉及使用无引线心脏起搏器以用于对患者的心脏进行监视、起搏和/或除颤的系统。在本公开的示例中,无引线心脏起搏器(LCP)被配置为感测心脏活动并且使患者的心脏起搏并且在患者心脏的心室内是任意放置(disposable)的。LCP包括外壳、相对于外壳固定的第一电极以及相对于外壳固定并与第一电极间隔开的第二电极。控制器被设置在外壳内并且可操作地耦合到第一电极和第二电极,使得控制器能够经由第一电极和第二电极接收心脏的心电信号。压力传感器可以相对于外壳而设置并且可以可操作地耦合到控制器,控制器被配置为从压力传感器接收信号。加速度计可以相对于外壳而设置并且可以可操作地耦合到控制器,控制器被配置为从加速度计接收信号。控制器可以被配置为至少部分地基于以下信号来确定心房收缩定时基准(contraction timing fiducial):从压力传感器接收到的两个或更多个信号;从加速度计接收到的表示心音和/或心内膜加速度的信号;以及经由第一电极和第二电极接收到的心电信号,并然后使用心房收缩定时基准生成并递送心室起搏脉冲。
作为上述实施例中的任一个的替换或附加,控制器可以被配置为至少部分地基于从压力传感器接收到的信号和从加速度计接收到的信号来确定心房收缩定时基准。
作为上述实施例中的任一个的替换或附加,控制器可以被配置为至少部分地基于从压力传感器接收到的信号和经由第一电极和第二电极接收到的心电信号来确定心房收缩定时基准。
作为上述实施例中的任一个的替换或附加,控制器可以被配置为至少部分地基于从压力传感器接收到的信号中感测到的A波和从加速度计接收到的信号中的S4心音相关联的感测到的信号来确定心房收缩定时基准。
作为上述实施例中的任一个的替换或附加,从压力传感器接收到的信号可以包括心室压力相对于时间的变化(dP/dt)。
作为上述实施例中的任一个的替换或附加,从压力传感器接收到的信号可以包括A波。
作为上述实施例中的任一个的替换或附加,从压力传感器接收到的信号可以包括脉冲压力。
作为上述实施例中的任一个的替换或附加,从加速度计接收到的信号可以包括心音信号或心内膜加速度信号。
作为上述实施例中的任一个的替换或附加,经由第一电极和第二电极接收到的心电信号可以包括心电图(ECG)的至少一部分。
作为上述实施例中的任一个的替换或附加,经由第一电极和第二电极接收到的心电信号可以包括P波。
作为上述实施例中的任一个的替换或附加,经由第一电极和第二电极接收到的心电信号可以包括QRS波群,从其可以确定QRS宽度。
作为上述实施例中的任一个的替换或附加,经由第一电极和第二电极接收到的心电信号可以包括两个连续的R波,从其可以确定R波到R波间隔。
在本公开的另一个示例中,无引线心脏起搏器(LCP)被配置为感测心脏活动并且使患者的心脏起搏并且在患者心脏的心室内是可任意放置的。LCP包括外壳、相对于外壳固定的第一电极以及相对于外壳固定并与第一电极间隔开的第二电极。控制器设置在外壳内并且可操作地耦合到第一电极和第二电极,使得控制器能够经由第一电极和第二电极接收心脏的心电信号。控制器可以被配置为至少部分地基于以下来确定心房收缩定时基准:第一心跳中的心房收缩的感测到的指示以及第一心跳、紧接在前心跳和/或紧接在后心跳中的心室收缩的感测到的指示,并使用心房收缩定时基准生成并递送心室起搏脉冲。
作为上述实施例中的任一个的替换或附加,LCP还可以包括相对于外壳而设置并可操作地耦合到控制器的压力传感器。
作为上述实施例中的任一个的替换或附加,LCP还可以包括相对于外壳而设置并可操作地耦合到控制器的加速度计。
作为上述实施例中的任一个的替换或附加,提供心房收缩指示的第一信号可以包括S3心音信号、S4心音信号、A波信号和/或P波信号中的一个或多个。
作为上述实施例中的任一个的替换或附加,提供心室收缩指示的第二信号可以包括脉压信号、dP/dt信号、R波到R波间隔、QRS波群宽度、和/或心室压力-容积环参数中的一个或多个。
在本公开的另一个示例中,使用患者的左心室内设置的无引线心脏起搏器(LCP)生成心室起搏脉冲的方法包括:感测指示出患者心脏的心房收缩的第一信号并且感测与患者心脏的心房收缩有关的第二不同信号。可以至少部分地基于指示出患者心脏的心房收缩的感测到的第一信号以及与患者心脏的心房收缩相关的感测到的第二信号来确定心房收缩定时基准。可以使用心房收缩定时基准生成并递送心室起搏脉冲。
作为上述实施例中的任一个的替换或附加,与患者心脏的心房收缩相关的第二信号可以包括:对患者心脏的心房收缩之后的患者心脏的心室收缩的指示。
作为上述实施例中的任一个的替换或附加,经由LCP的压力传感器生成第一信号和第二信号中的至少一个。
以上发明内容不旨在描述本公开的每个实施例或每个实施方式。通过参考结合附图的以下描述和权利要求,本公开的优点和成就以及更全面的理解将变得显而易见并被领会。
附图说明
考虑到结合附图的各种说明性实施例的以下描述,可以更全面地理解本公开,在附图中:
图1是根据本公开的示例的说明性系统的高度示意图;
图2是心电图(ECG)的图形表示,其示出了心脏的电信号与心脏收缩的机械指示之间的时间关系;
图3是示出了心脏内的示例压力和容积随时间的曲线图。
图4是可用于图1的系统的说明性无引线心脏起搏器(LCP)的示意性框图。
图5是可用于图1的系统的说明性无引线心脏起搏器(LCP)的示意性框图。
图6是可用于图1的系统的说明性无引线心脏起搏器(LCP)的示意性框图。
图7是可用于图1的系统的说明性无引线心脏起搏器(LCP)的示意性框图。
图8是根据本公开的示例的说明性LCP的示意性框图。
图9是可以与图8的LCP结合使用的另一说明性医疗装置的示意性框图。
图10是包括彼此通信的多个LCP和/或其他装置的示例性医疗系统的示意图;
图11是根据本公开的示例的包括LCP和另一医疗装置的系统的示意图;
图12是说明性可植入无引线心脏装置的侧视图;
图13是用于人心脏的心室的说明性压力-容积环;
图14是用于生成心室起搏脉冲的说明性方法的流程图;
图15是用于生成心室起搏脉冲的说明性方法的流程图;并且
图16是用于确定心室起搏时间的说明性方法的流程图。
虽然本公开可以进行各种修改和替换形式,但是其细节已经通过附图中的示例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各方面限制于所描述的特定说明性实施例。相反,意图是覆盖落入本公开的精神和范围内的所有修改、等同物和替换物。
具体实施方式
应该参考附图阅读以下描述,其中不同附图中的类似元件编号相同。描述和不一定按比例绘制的附图描绘了说明性实施例,且不旨在限制本公开的范围。
除非内容另有明确指示,否则本文假设所有数字均由术语“大约”修饰。由端点表述的数值范围包括该范围内包含的所有数字(例如,1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的,单数形式“一”、“一个”和“该”包括复数指示物,除非内容另有明确指示。如在本说明书和所附权利要求中所使用的,术语“或”通常用于其意义包括“和/或”,除非内容另有明确指示。
注意的是,说明书中对“实施例”、“一些实施例”、“其它实施例”等的引用指示了所述实施例可以包括特定的特征、结构或特性,但是每个实施例可以不一定包括特定的特征、结构或特性。而且,这种短语不一定是指同一实施例。此外,当结合实施例描述特定的特征、结构或特性时,预期是除非明确地相反说明,否则可以将特征、结构或特性应用于其他实施例,无论是否明确地描述。
正常健康的心脏通过在整个心脏中传导内在生成的电信号而引起收缩。这些内在信号致使心脏的肌细胞或组织以协调的方式收缩。这些收缩迫使血液进出心脏,使血液循环通过身体的其余部分。许多患者患有影响其心脏的高效操作的心脏病。例如,一些心脏发展了不再生成或高效传导内在电信号的患病组织。在一些示例中,患病的心脏组织可以以不同的频率(rate)传导电信号,从而致使心脏的不同步和低效的收缩。在其他示例中,心脏可以以如此低的频率生成内在信号,使得心率变得危险地低。在又其他示例中,心脏可能以异常高的频率生成电信号,甚至导致心脏纤维性颤动。可植入医疗装置通常用于通过向患者的心脏递送一种或多种类型的电刺激疗法来治疗这种病症。
图1是示出了可以用于感测和/或起搏心脏H的说明性系统10的示意图。在一些情况下,系统10还可被配置为能够电击(shock)心脏H。心脏H包括右心房RA和右心室RV。心脏H还包括左心房LA和左心室LV。在一些情况下,说明性系统10包括SICD(皮下可植入心律复律除颤器)12。虽然在该图中未示出,但在一些情况下,SICD 12可以包括引线,其可被配置为相对于患者胸骨皮下放置并在患者的心脏之外。在一些情况下,引线可以围绕胸骨或穿过胸骨延伸,并且可以邻近胸骨的内表面并在患者心脏的外部而固定。SICD 12可以被配置为感测由心脏H生成的电活动以及向心脏H提供电能,以便将心脏H从不期望的心律电击为期望的心律。
在一些情况下,系统10可以包括LCP 14,其可以被配置为感测和/或起搏心脏H。虽然示出了单个LCP 14,但是将理解的是,两个或更多个LCP 14可以植入被植入在心脏H中或其上。LCP 14可以植入到心脏的任何腔室中,诸如右心房RA、左心房LA、右心室RV和左心室LV。当提供多于一个LCP时,每个LCP可以植入在不同的腔室中。在一些情况下,多个LCP可以植入在心脏H的单个腔室内。
在一些情况下,可以同时植入SICD 12和LCP 14。在一些情况下,取决于特定患者的心脏缺陷,如果/当患者的心脏失代偿并且有必要使心脏H起搏时,可以首先植入SICD12,并可以在以后植入一个或多个LCP 14。在一些情况下,预期的是可以首先植入一个或多个LCP 14,以便感测和起搏心脏H。当对可能除颤的需要变得明显时,可以随后植入SICD12。无论植入顺序或序列如何,将理解的是,SICD 12和LCP 14可以使用任何期望的通信协议(诸如通过患者身体的传导通信)彼此通信。
参考图2,将理解的是,心脏H经由穿过心脏组织并且可以由诸如但不限于图1的SICD 12和/或LCP 14的植入式装置检测的电信号来控制。图2包括心电图(ECG)16的一部分以及心音迹线18。如ECG16中可见的,心跳包括指示心房去极化的P波。包括Q波、R波和S波的QRS波群表示心室去极化。T波指示心室的复极化。将理解的是,ECG16可以由诸如但不限于图1的SICD 12和/或LCP 14的植入式装置检测。
当心脏H跳动时,许多心音也可以是可检测的。将理解的是,心音可以被认为是心脏跳动的机械指示的示例。其他说明性机械指示可以包括,例如,由LCP中的加速度计检测到的心脏壁的移动或心内膜加速度;由SICD中的加速度计检测到的心脏壁的移动或加速度;由LCP的压力传感器检测到的心脏H的腔室中的压力、压力变化或压力变化率;由声学传感器(例如,加速度计、麦克风等)检测到的心脏运动引起的声学信号;和/或心脏腔室跳动的任何其他合适的指示。
电信号通常指示心脏H的一部分收缩,并然后存在对应的机械指示。在一些情况下,可以存在:第一心音,表示为S1并通过在心室收缩期间关闭二尖瓣和三尖瓣生成的振动所产生;第二心音,表示为S2并通过关闭主动脉瓣和肺动脉瓣所产生;第三心音,表示为S3并且是通过血液从右心房RA快速进入右心室RV和从左心房LA快速进入左心室LV而引起的早期舒张音;以及第四心音,表示为S4并且是对应于主动心房收缩期间的后期心室充盈的后期舒张音。
因为心音是响应于电信号的心肌收缩或舒张的结果,所以将理解的是,由ECG16指示的电信号与由心音迹线18所示的示例中指示的对应机械指示之间存在延迟。例如,ECG16的P波是触发心房收缩的电信号。S4心音是由心房收缩引起的机械信号。在一些情况下,可以使用P波和S4心音之间的这种关系。例如,如果可以检测到这些信号之一,则该关系可以用作帮助搜索其它信号的定时机制。例如,如果可以检测到P波,则可以定义和搜索遵循P波的窗口,以便找到和/或隔离对应的S4心音。在一些情况下,对两个信号的检测可以指示检测到的心房收缩中的增加的置信水平。在一些情况下,对任一信号的检测可足以识别心房收缩。对心房收缩的识别可以用于识别心房收缩定时基准(例如心房收缩的定时标记)。
在一些情况下,某些电信号和/或机械指示的关系可以用于预测同一心跳内的其他电信号和/或机械指示的定时。可替换地或另外地,对应于特定心跳的某些电信号和/或机械指示的定时可以用于预测后续心跳内的其他电信号和/或机械指示的定时。将理解的是,当心脏H经历心动周期时,心脏H内的血压和血量将随时间变化。图3说明了这些参数如何与电信号和对应的机械指示相匹配。
图3是示出了心脏内的示例压力和容积随时间的曲线图。更具体地,图3示出了在两次连续心跳期间心脏H的主动脉压、左心室压、左心房压、左心室容积、心电图(ECG或egram)和心音的说明性示例。心动周期可以以心脏舒张开始并且二尖瓣打开。心室压力低于心房压力,导致心室充血。在心室充盈期间,如所示出的,主动脉压力缓慢下降。在心脏收缩期间,心室收缩。当心室压力超过心房压力时,二尖瓣关闭,生成S1心音。在主动脉瓣打开之前,发生等容收缩阶段,其中心室压力迅速增加但心室容积不会显著改变。一旦心室压力等于主动脉压,主动脉瓣就打开,并且射血阶段开始,其中血液从左心室射入主动脉。射血阶段持续直到心室压力低于主动脉压为止,此时主动脉瓣关闭,生成S2心音。此时,等容舒张阶段开始,并且心室压力迅速下降直至其被心房压力超过为止,此时二尖瓣打开,并且周期重复。肺动脉、右心房和右心室的心脏压力曲线以及右心室的心脏容积曲线可以与图3中所示的类似。在许多情况下,右心室中的心脏压力比左心室中的心脏压力更低。
图4是说明性LCP 14的示意图。在一些情况下,如所指示的,LCP 14可以被认为被配置为感测心脏活动并且起搏患者的心脏H。在一些情况下,LCP 14在心脏H的心室诸如右心室RV或左心室LV内可以是任意放置的。LCP 14可以被认为包括外壳20、相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第一电极22、以及相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第二电极24。第二电极24可以与第一电极22间隔开。在一些情况下,如所说明的,虽然在所有情况下都不要求,但第一电极22可以设置在外壳20的第一端26处或其附近,并且第二电极24可以设置在外壳20的第二端28处或其附近。
LCP 14还可以包括控制器30,其设置在外壳20内并且经由第一电连接32可操作地耦合到第一电极22且经由第二电连接34可操作地耦合到第二电极24。在一些情况下,控制器30可以能够经由第一电极22和第二电极24接收包括对心房(或其他)收缩的电指示的电信号(例如,ECG16的P波,参见图2)。在一些情况下,控制器30可以接收来自诸如SICD 12(图1)的远程装置的包括对心房(或其他)收缩的指示的电信号(例如,传导通信信号)。在一些情况下,控制器30还可以被配置为,至少部分地基于在第一心跳中的心房收缩的感测到的指示和/或在第一心跳、紧接在前心跳和/或紧接在后心跳中的心室收缩的感测到的指示,来确定心房收缩定时基准。在一些情况下,控制器30可以被配置为,使用心房收缩定时基准生成并递送心室起搏脉冲(例如,在A-V延迟之后)。
在一些情况下,LCP 14可以包括加速度计36,其设置在外壳20内并且经由电连接38可操作地耦合到控制器30。在一些情况下,如关于后续附图进一步讨论的,LCP 14可以包括可选的压力传感器。在一些情况下,控制器30可以被配置为经由来自加速度计36的信号而检测心房(或其他)收缩的机械指示。在一些情况下,心房收缩的机械指示可以包括但不限于S4心音。虽然LCP 14被示出为包括加速度计,但是将理解的是,其他传感器可以能够提供表示心房(或其他)收缩的机械指示的信号。例如,在一些情况下,LCP 14可以包括麦克风。在一些情况下,LCP 14可以包括超音波测微计、心脏机械传感器,其包括例如嵌入式压电材料或其他压电传感器。在一些情况下,LCP可以包括用于感测对心房收缩的指示的压力传感器。这些仅是示例。
在一些情况下,提供对心房收缩的指示的信号可以包括S3心音信号、S4心音信号、A波信号和/或P波信号中的一个或多个。在一些情况下,提供对心室收缩的指示的信号可以包括脉压信号、dP/dt信号、R波到R波间隔、QRS波群宽度和/或心室压力-容积环参数中的一个或多个。这些仅是示例。
图5是说明性LCP 44的示意图。在一些情况下,如所指示的,LCP 44可以被认为被配置为感测心脏活动并且起搏患者的心脏H。在一些情况下,LCP 44在心脏H的心室诸如右心室RV或左心室LV内可以是任意放置的。LCP 44可以被认为包括外壳20、相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第一电极22、以及相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第二电极24。第二电极24可以与第一电极22间隔开。在一些情况下,如所说明的,虽然在所有情况下都不要求,但第一电极22可以设置在外壳20的第一端26处或其附近,并且第二电极24可以设置在外壳20的第二端28处或其附近。
LCP 14还可以包括控制器30,其设置在外壳20内并且经由第一电连接32可操作地耦合到第一电极22且经由第二电连接34可操作地耦合到第二电极24。在一些情况下,控制器30可以能够经由第一电极22和第二电极24接收包括对心房(或其他)收缩的电指示的电信号(例如,ECG16的P波,参见图2)。在一些情况下,经由植入在心室中的LCP的电极22和24检测远场P波可以具有相对低的信噪比。使用SICD引线检测P波可以具有更高的信噪比。在一些情况下,控制器30可以接收来自诸如SICD 12(图1)的远程装置的包括对心房(或其他)收缩的指示的电信号(例如,传导通信信号)。
在一些情况下,LCP 44可以包括加速度计36,其设置在外壳20内并且经由电连接38可操作地耦合到控制器30。在一些情况下,LCP 44还可以包括压力传感器40,其设置在外壳20内并且经由电连接42可操作地耦合到控制器30。在一些情况下,压力传感器信号可以响应于患者心脏的心房收缩。同样地,加速度计信号可以响应于患者心脏的心房收缩。
在一些情况下,压力信号可以用于确定多个参数。例如,压力信号可以用于确定或检测A波(心房驱血(atrial kick))。在另一示例中,压力信号可以用于确定或检测与S4相关联的压力脉冲或压力振动,其可以例如处于25-30Hz范围内。在一些情况下,使用压力信号比使用加速度计信号更容易检测S4心音,特别是因为此时(心室正在充盈)心室压力基本上没有变化。在另一示例中,压力信号可以用于确定心室压力相对于时间的变化(dP/dt)。
在一些情况下,控制器30可以被配置为经由来自加速度计36的信号而检测指示心房(或其他)收缩的一个或多个信号。在一些情况下,从加速度计36接收到的信号可以包括心音信号(例如S4)或心内膜加速度信号。虽然LCP 14被示出为包括加速度计36和压力传感器40,但是将理解的是,其他传感器也可以能够提供表示对心房(或其他)收缩的机械指示的信号。例如,在一些情况下,LCP 14可以包括麦克风。在一些情况下,LCP 44可以包括超音波测微计、心脏机械传感器,其包括例如嵌入式压电材料或其他压电传感器。这些仅是示例。
在一些情况下,控制器30还可以被配置为,至少部分地基于以下中的两个或更多个来确定心房收缩定时基准:从压力传感器40接收到的信号;从加速度计36接收到的信号(例如,表示心音和/或心内膜加速度);以及经由第一电极22和第二电极24接收到的心电信号。在一些情况下,经由第一电极22和第二电极24接收到的心电信号可以包括至少一部分心电图(ECG)。在一些情况下,经由第一电极22和第二电极24接收到的心电信号可以包括P波。在一些情况下,经由第一电极22和第二电极24接收到的心电信号可以包括QRS波群,从中可以确定QRS宽度。在一些情况下,经由第一电极22和第二电极24接收到的心电信号可以包括两个连续的R波,从中可以确定R波到R波间隔。在一些情况下,心电信号可以包括来自另一装置(例如,SICD装置)的经传导或其他传送的电信号,其包括对心脏H的心房或其他收缩的指示。在一些情况下,控制器30可以被配置为使用心房收缩定时基准生成并递送心室起搏脉冲。
在一些情况下,控制器30可以被配置为,至少部分地基于从压力传感器40接收到的信号和从加速度计36接收到的信号来确定心房收缩定时基准。在一些情况下,控制器30可以被配置为,至少部分地基于从压力传感器40接收到的信号和经由第一电极22和第二电极24接收到的心电信号来确定心房收缩定时基准。在一些情况下,控制器30可以被配置为至少部分地基于以下来确定心房收缩定时基准:从压力传感器40接收到的信号中的感测到的A波,和从加速度计36接收到的信号中的S4心音相关联的感测到的信号。
在一些情况下,控制器30可以被配置为确定用于将心室起搏脉冲递送到患者心脏H的心室的起搏时间,并且控制器30可以至少部分地基于从压力传感器40接收到的压力信号来确定起搏时间。例如,在一些情况下,控制器可以被配置为至少部分地基于接收到的压力信号和接收到的加速度计信号来确定起搏时间。作为另一示例,在一些情况下,控制器30可以被配置为至少部分地基于在接收到的压力信号和/或接收到的加速度计信号中所表示的心音或心内膜加速度来确定起搏时间。
在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号和接收到的心电信号来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号、接收到的加速度计信号以及接收到的心电信号来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号中所表示的舒张压来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号中所表示的A波来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号中所表示的收缩压来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号中所表示的心脏收缩期间的dP/dt参数(例如,在心室中最大化dP/dt时的起搏)来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于接收到的压力信号在心脏收缩期间何时穿过预定阈值来确定起搏时间。在一些情况下,控制器30可以被配置为至少部分地基于相对于先前确定的心房收缩定时基准的A-V延迟来确定起搏时间,并且控制器30可以至少部分地基于以下中的一个或多个来调整所述A-V延迟:在当前、先前和/或随后的心动周期期间接收到的压力信号、接收到的加速度计信号以及接收到的心电信号。
在一些情况下,控制器30可以被配置为确定用于将心室起搏脉冲递送到患者心脏H的心室的心室起搏时间。例如,在一些情况下,控制器30可以至少部分地基于患者心脏H的心房收缩事件的指示和患者当前姿势的指示来确定心室起搏时间。将理解的是,患者的心脏要求或血液泵送需求可以取决于患者是躺下、坐着还是站立等而变化。在一些情况下,例如,心房收缩事件的指示可以主要地或排他地基于接收到的加速度计信号(如果患者姿势的指示是躺下的话),和可以主要地或排他地基于接收到的压力信号(如果患者姿势的指示是直立的话)。当患者休息(例如斜躺(reclined))时,加速度计信号的信噪比可能更大,并且当患者活动(例如直立)时,压力信号的信噪比可能更大。在一些情况下,控制器30可以被配置为至少部分地基于加速度计信号来确定患者姿势的指示。
在一些情况下,控制器30可以被配置为当患者姿势的指示是直立时至少部分地基于压力传感器信号中所指示的LV压力参数来确定心室起搏时间。相反地,控制器30可以被配置为当患者姿势的指示是斜躺时至少部分地基于压力传感器信号和/或加速度计信号中所指示的心音来确定心室起搏时间。在一些情况下,控制器30可以被配置为当患者姿势的指示是直立时确定心室起搏时间以实现较低的被动心室充盈,并且当患者姿势的指示是斜躺时确定心室起搏时间以实现较高的被动心室充盈(例如,最大化舒张间期、将S2增加到A波上升间隔、降低心率等)。这可以以如下方式操作心脏:减少心脏的拉伸应力,同时在代谢需求相对低(例如斜躺)时的时间期间仍然满足患者的当前代谢需求;并且当代谢需求较高(例如直立)时以最大化泵送能力的方式操作心脏。这可以通过在低代谢需求的时间期间允许心脏更多地“休息”来帮助降低患者心脏失代偿的频率。虽然姿势可以用作代谢需求的指标,但是预期的是代谢需求可以基于任何数量的其他参数(包括例如心率、患者的呼吸、患者的活动水平、姿势、血液气体、血液分析物(例如乳酸盐或去甲肾上腺素)、心脏传导速度(例如PR间期或QT间期)和/或睡眠状态)来估计。
图6是说明性LCP 54的示意图。在一些情况下,如所指示的,LCP 54可以被认为被配置为感测心脏活动并起搏患者的心脏H。在一些情况下,LCP 54在心脏H的心室(诸如右心室RV或左心室LV)内可以是可任意放置的。LCP 54可以被视为包括外壳20、相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第一电极22、以及相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第二电极24。第二电极24可以与第一电极22间隔开。在一些情况下,如所说明的,虽然在所有情况下都不要求,但第一电极22可以设置在外壳20的第一端26处或其附近,并且第二电极24可以设置在外壳20的第二端28处或其附近。
LCP 54还可以包括控制器30,其设置在外壳20内并且经由第一电连接32可操作地耦合到第一电极22,并且经由第二电连接34可操作地耦合到第二电极24。在一些情况下,控制器30可以能够经由第一电极22和第二电极24接收表示心脏活动的电信号。在一些情况下,控制器30可以接收包括对心房(或其他)收缩的电指示的信号(例如,ECG 16的P波,参见图2)。在一些情况下,控制器30可以接收来自诸如SICD 12(图1)的远程装置的包括对心房(或其他)收缩的指示的电信号(例如,传导通信信号)。
在一些情况下,LCP 54可以包括存储器56,其经由电连接58可操作地耦合到控制器30。在一些情况下,例如,存储器56可以被配置为存储关于先前确定的心房收缩定时基准的信息以及其他信息。
在一些情况下,LCP 54可以包括加速度计36,其设置在外壳20内并且经由电连接38可操作地耦合到控制器30。在一些情况下,LCP 54还可以包括压力传感器40,其设置在外壳20内并且经由电连接42可操作地耦合到控制器30。控制器30可以例如被配置为从加速度计36接收加速度计信号和/或从压力传感器40接收压力传感器信号。在一些情况下,例如,控制器30可以被配置为至少部分地基于来自压力传感器40的压力信号来确定相对于先前确定的心房收缩定时基准的A-V延迟。在一些情况下,控制器30可以被配置为至少部分地基于加速度计信号来调整A-V延迟。在一些情况下,控制器30可以被配置为,在遵循先前确定的心房收缩定时基准来调整的A-V延迟之后生成心室起搏脉冲。
在一些情况下,由控制器30接收到的压力信号可以包括脉压,并且控制器30可以被配置为至少部分地基于脉压而相对于先前确定的心房收缩定时基准来调整A-V延迟。在一些情况下,由控制器30接收到的压力信号包括压力随时间的变化率(dP/dt),并且控制器30可以被配置为至少部分地基于dP/dt而相对于先前确定的心房收缩定时基准来调整A-V延迟。在一些情况下,可以调整A-V延迟以使在心室中感测到的dP/dt最大化。在一些情况下,可以调整A-V延迟以使心脏舒张时在心室中感测到的负dP/dt最小化。在一些情况下,可以调整A-V延迟以实现最小心室压力脉冲宽度(例如,最大dP/dt与最大负dP/dt之间的宽度)。在一些情况下,心音与LV压力波形一起可以用于分离出心脏H的各种定时分量,诸如射血时间、等容收缩时间、等容关系时间等。
在一些情况下,由控制器30接收到的压力信号可以包括A波信号,并且控制器30可以被配置为逐渐减小A-V延迟直到未检测到A波信号为止,并然后逐渐增加A-V延迟直到刚再次检测到A波信号为止并且LV压力上升的开始在A波的顶部的右边,此时A-V延迟可以被认为是最佳的。在一些情况下,控制器30可以被配置为响应于经由第一电极22和第二电极24接收到或测量到的LV容积相关的阻抗信号而调整A-V延迟,并且控制器30可以相对于先前确定的心房收缩定时基准来调整A-V延迟,以便增加使用LV容积相关的阻抗信号所估计的LV射血分数。
在一些情况下,控制器30可以被配置为响应于包括QRS波群(从其可以确定QRS宽度)的经由第一电极22和第二电极24接收到的心电信号来调整A-V延迟,并且控制器30可以被配置为相对于先前确定的心房收缩定时基准来调整A-V延迟,以便最小化QRS宽度。在一些情况下,控制器30可以被配置为响应于来自压力传感器40和/或加速度计36的指示了二尖瓣反流的接收到的信号来调整A-V延迟,并且控制器30可以被配置为相对于先前确定的心房收缩定时基准来调整A-V延迟,以最小化检测到的二尖瓣反流。
图7是说明性LCP 64的示意图。在一些情况下,如所指示的,LCP 64可以被认为被配置为感测心脏活动并起搏患者的心脏H。在一些情况下,LCP 64在心脏H的心室(诸如右心室RV或左心室LV)内可以是可任意放置的。LCP 64可以被视为包括外壳20、相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第一电极22、以及相对于外壳20固定并暴露于外壳20外部的环境(例如血液、组织等)的第二电极24。第二电极24可以与第一电极22间隔开。在一些情况下,如所说明的,虽然在所有情况下都不要求,但是第一电极22可以设置在外壳20的第一端26处或其附近,并且第二电极24可以设置在外壳20的第二端28处或其附近。
LCP 64还可以包括控制器30,其设置在外壳20内并且经由第一电连接32可操作地耦合到第一电极22且经由第二电连接34可操作地耦合到第二电极24。在一些情况下,控制器30可以能够经由第一电极22和第二电极24接收表示心脏活动的电信号。在一些情况下,控制器30可以接收包括对心房(或其他)收缩的电指示的信号(例如,ECG16的P波,参见图2)。在一些情况下,控制器30可以接收来自诸如SICD 12(图1)的远程装置的包括对心房(或其他)收缩的指示的电信号(例如,传导通信信号)。
在一些情况下,LCP 64可以包括第一传感器66和第二传感器68。第一传感器66可以设置在外壳20内,并且可以经由电连接70可操作地耦合到控制器30。第二传感器68可以设置在外壳20内,并且可以经由电连接72可操作地耦合到控制器30。在一些情况下,第一传感器66可以包括加速度计。在一些情况下,第二传感器68可以包括压力传感器。在一些情况下,第一传感器66可以向控制器30提供第一传感器信号,其中第一传感器信号响应于患者心脏的心房收缩。在一些情况下,第二传感器68可以向控制器30提供第二传感器信号,其中第二传感器信号响应于患者心脏的心房收缩。
在一些情况下,来自第一传感器66的信号可以用第一权重加权,且来自第二传感器68的信号可以用第二权重加权。在一些情况下,例如,应用于第一信号的第一权重和/或应用于第二信号的第二权重可以至少部分地基于对应信号中的置信水平。在一些情况下,权重可以至少部分地基于对应信号的信噪比(SNR)。在一些情况下,控制器30可以例如优先地更多依赖于来自第一传感器66的第一信号而更少依赖于来自第二传感器68的第二信号。在一些情况下,控制器30可以优先地更多依赖于来自第二传感器68的第二信号,而更少依赖于来自第一传感器66的第一信号。
在一些情况下,控制器30可以被配置为确定用于将心室起搏脉冲递送到患者心脏的心室的心室起搏时间。在一些情况下,控制器30可以至少部分地基于患者心脏的心房收缩事件的指示,并且在一些情况下患者心脏的代谢需求的指示,来确定心室起搏时间。如果代谢需求的指示低于代谢需求阈值,则心房收缩事件的指示可以主要或排他地基于接收到的第一信号,并且如果代谢需求的指示高于代谢需求阈值,则可以主要或排他地基于接收到的第二信号。在一些情况下,代谢需求的指示可以至少部分地基于接收到的第一传感器信号。在一些情况下,代谢需求的指示可以至少部分地基于接收到的第二传感器信号。在一些情况下,代谢需求的指示可以至少部分地基于接收到的心电信号。控制器30可以被配置为在心室起搏时间处生成心室起搏脉冲。
在示例中,第一传感器66或第二传感器68可以是加速度计,并且控制器30可以被配置为至少部分地基于来自加速度计的加速度计信号来确定患者的姿势,并且可以至少部分地基于所确定的姿势来确定代谢需求的指示。在另一示例中,第一传感器66或第二传感器68可以是加速度计,并且控制器30可以被配置为至少部分地基于来自加速度计的加速度计信号来确定患者的活动水平,并且至少部分地基于所确定的活动水平来确定代谢需求的指示。
在另一示例中,第一传感器66和第二传感器68可以包括加速度计和压力传感器,并且控制器30可以被配置为尝试经由来自压力传感器的压力信号来检测A波。控制器30还可以至少部分地基于以下来确定心室起搏时间:(1)当检测到A波时的A波;和(2)当未检测到A波时,不是A波,而是从压力传感器接收到的压力信号和/或从加速度计接收到的加速度计信号中的一个或多个。在包括加速度计和压力传感器的第一传感器66和第二传感器68的另一示例中,控制器30可以被配置为当代谢需求的指示高于代谢需求阈值时,至少部分地基于在压力传感器的压力信号中所指示的LV压力参数来确定心室起搏时间,并且当代谢需求的指示低于代谢需求阈值时,至少部分地基于压力传感器的压力信号和/或加速度计的加速度计信号中所指示的心音来确定心室起搏时间。
在包括加速度计和压力传感器的第一传感器66和第二传感器68的另一示例中,控制器30可以被配置为经由压力传感器和/或加速度计检测S2心音并且经由压力传感器检测A波。在一些情况下,控制器30可以被配置为,当代谢需求的指示超过舒张阈值(relaxationthreshold)时确定实现较小的S2至A波间隔的心室起搏时间,并且当代谢需求的指示不超过舒张阈值时确定实现较大的S2至A波间隔的心室起搏时间。在一些情况下,控制器30可以被配置为经由压力传感器和/或加速度计检测S2心音并且经由压力传感器和/或加速度计检测S1心音。在一些情况下,控制器30可以被配置为,当代谢需求的指示超过舒张阈值时确定实现较小的S2至S1间隔的心室起搏时间,并且当代谢需求的指示不超过舒张阈值时确定实现较大的S2至S1间隔的心室起搏时间。舒张阈值被设置为对应于患者何时处于松弛(相对于活动)状态。
在一些情况下,第一传感器66或第二传感器68可以包括压力传感器,并且控制器30可以被配置为,当代谢需求的指示高于舒张阈值时,确定实现LV压力随时间的较高变化率(dP/dt)的心室起搏时间,并且当代谢需求的指示低于舒张阈值时,确定实现LV压力随时间的较低变化率(dP/dt)的心室起搏时间。在又另一示例中,控制器30可以被配置为,当代谢需求的指示高于舒张阈值时,确定实现较低的被动心室充盈的心室起搏时间,并且当代谢需求的指示低于舒张阈值时,确定实现较高的被动心室充盈的心室起搏时间。
预期的是,上面引用的舒张阈值可以不是单个阈值。例如,在一些情况下,舒张阈值可以包括滞后,其中取决于患者是从松弛状态转变到活动状态,还是从活动状态转变到松弛状态,而应用不同的舒张阈值。
图8描绘了另一说明性无引线心脏起搏器(LCP),其可以植入在患者内并且可以操作以向心脏递送适当的治疗,诸如递送抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)、心动过缓治疗、和/或类似物。如图8中可以看出的,LCP 100可以是紧凑型装置,其中所有组件都容纳在外壳120内或直接在外壳120上。在一些情况下,LCP 100可以被认为是LCP 14(图1和3)、LCP 44(图5)、LCP 54(图6)和/或LCP 64(图7)中的一个或多个的示例。在图8所示的示例中,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、电池112以及电极布置114。取决于应用,LCP 100可以包括更多或更少的模块。
通信模块102可以被配置为与位于LCP 100外部的诸如传感器、其他医疗装置(诸如SICD)和/或类似物的装置通信。这种装置可以位于患者身体的外部或内部。不管位置如何,外部装置(即,在LCP 100外部但不一定在患者身体外部)可以经由通信模块102与LCP100通信以实现一个或多个期望的功能。例如,LCP 100可以通过通信模块102将诸如感测到的电信号、数据、指令、消息、R波检测标记等的信息传送到外部医疗装置。外部医疗装置可以使用所传送的信号、数据、指令、消息、R波检测标记等,以执行各种功能,诸如确定心律失常的发生、递送电刺激治疗、存储接收到的数据和/或执行任何其他合适的功能。LCP 100可以另外地通过通信模块102从外部医疗装置接收诸如信号、数据、指令和/或消息的信息,并且LCP 100可以使用接收到的信号、数据、指令和/或消息来执行各种功能,诸如确定心律失常的发生、递送电刺激治疗、存储接收到的数据和/或执行任何其他合适的功能。通信模块102可以被配置为使用一种或多种方法来与外部装置通信。例如,通信模块102可以经由适合通信的射频(RF)信号、电感耦合、光信号、声信号、传导通信信号和/或任何其他信号进行通信。
在图8所示的示例中,脉冲发生器模块104可以电连接到电极114。在一些示例中,LCP 100可以另外包括电极114'。在这样的示例中,脉冲发生器104还可以电连接到电极114'。脉冲发生器模块104可以被配置为生成电刺激信号。例如,脉冲发生器模块104可以通过使用LCP 100内的电池112中所存储的能量来生成和递送电刺激信号,并且经由电极114和/或114'递送所生成的电刺激信号。可替换地或另外地,脉冲发生器104可以包括一个或多个电容器,并且脉冲发生器104可以通过从电池112汲取能量来对一个或多个电容器充电。脉冲发生器104然后可以使用一个或多个电容器的能量来经由电极114和/或114'递送所生成的电刺激信号。在至少一些示例中,LCP 100的脉冲发生器104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脉冲发生器104,以便选择电极114/114'(和/或其他电极)中的哪些电极来进行脉冲发生器104递送电刺激治疗。脉冲发生器模块104可以生成并递送具有特定特征或特定序列的电刺激信号,以便提供多种不同刺激治疗中的一种或多种。例如,脉冲发生器模块104可以被配置为生成电刺激信号以提供电刺激治疗以对抗心动过缓、心动过速、心脏同步、心动过缓性心律失常、心动过速性心律失常、纤颤性心律失常、心脏同步性心律失常和/或产生任何其他合适的电刺激治疗。一些更常见的电刺激治疗包括抗心动过速起搏(ATP)治疗、心脏再同步治疗(CRT)和心脏复律/除颤治疗。
在一些示例中,LCP 100可以不包括脉冲发生器104。例如,LCP 100可以是诊断专用装置。在这样的示例中,LCP 100可以不向患者递送电刺激治疗。相反,LCP 100可以收集关于患者的心电活动和/或生理参数的数据,并且经由通信模块102将这种数据和/或确定传送到一个或多个其他医疗装置。
在一些示例中,LCP 100可以包括电感测模块106,并且在一些情况下,包括机械感测模块108。电感测模块106可以被配置为感测心脏的心电活动。例如,电感测模块106可以连接到电极114/114',并且电感测模块106可以被配置为接收通过电极114/114'所传导的心电信号。心电信号可以表示来自LCP 100被植入在其中的腔室的局部信息。例如,如果LCP100被植入在心脏的心室(例如RV、LV)内,则由LCP 100通过电极114/114'感测到的心电信号可以表示心室心电信号。在一些情况下,LCP 100可以被配置为检测来自其他腔室(例如远场)的心电信号,诸如来自心房的P波。
机械感测模块108可以包括一个或多个传感器,诸如加速度计、压力传感器、心音传感器、血氧传感器、化学传感器、温度传感器、流量传感器和/或被配置为测量患者的一个或多个机械/化学参数的任何其他合适的传感器。电感测模块106和机械感测模块108两者都可以连接到处理模块110,其可以提供表示感测到的机械参数的信号。虽然关于图8被描述为单独的感测模块,但是在一些情况下,电感测模块206和机械感测模块208可以根据需要组合成单个感测模块。
电极114/114'可以相对于外壳120固定,但暴露于LCP 100周围的组织和/或血液。在一些情况下,电极114通常可以设置在LCP 100的任一端上,并且可以与模块102、104、106、108和110中的一个或多个电通信。电极114/114'可以由外壳120支撑,虽然在一些示例中,电极114/114'可以通过短连接线连接到外壳120,使得电极114/114'不直接相对于外壳120固定。在LCP 100包括一个或多个电极114'的示例中,电极114'在某些情况下可以设置在LCP 100的侧面上,这可以增加LCP 100可以借由其而感测心电活动、递送电刺激和/或与外部医疗装置通信的电极的数量。电极114/114'可以由一种或多种生物相容的导电材料(诸如已知安全植入在人体内的各种金属或合金)构成。在一些情况下,连接到LCP 100的电极114/114'可以具有绝缘部分,其将电极114/114'与LCP 100的相邻电极、外壳120和/或其他部分电隔离。在一些情况下,电极114/114'中的一个或多个可以设置在远离外壳120延伸的尾部(未示出)上。
处理模块110可以被配置为控制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和/或机械感测模块108接收电信号。基于接收到的信号,处理模块110可以确定例如心脏H的运行中的异常。基于任何确定的异常,处理模块110可以控制脉冲发生器模块104根据一个或多个治疗来生成并递送电刺激,以治疗确定的异常。处理模块110还可以从通信模块102接收信息。在一些示例中,处理模块110可以使用这种接收到的信息来帮助确定是否正在发生异常、确定异常的类型、和/或响应于信息而采取特定行动。处理模块110可以另外控制通信模块102以向/从其他装置发送/接收信息。
在一些示例中,处理模块110可以包括预编程芯片,诸如超大规模集成(VLSI)芯片和/或专用集成电路(ASIC)。在这样的实施例中,芯片可以用控制逻辑进行预编程,以便控制LCP 100的操作。通过使用预编程的芯片,处理模块110可以使用比其他可编程电路(例如,通用可编程微处理器)更少的功率,同时仍然能够保持基本功能,从而潜在地增加LCP100的电池寿命。在其他示例中,处理模块110可以包括可编程微处理器。这种可编程微处理器可以允许用户修改LCP 100的控制逻辑(甚至在植入之后),从而允许LCP 100比使用预编程ASIC时更大的灵活性。在一些示例中,处理模块110还可以包括存储器,并且处理模块110可以在存储器上存储信息并从存储器读取信息。在其他示例中,LCP 100可以包括与处理模块110通信的单独存储器(未示出),使得处理模块110可以从单独存储器读取信息和向单独存储器写入信息。
电池112可以向LCP 100提供功率以用于其操作。在一些示例中,电池112可以是不可再充电的锂基电池。在其他示例中,根据需要,不可再充电的电池可以由其他合适的材料制成。因为LCP 100是可植入装置,所以在植入后可以限制对LCP 100的访问。因此,期望具有足够的电池容量以在诸如数天、数周、数月、数年或甚至数十年的治疗期间递送治疗。在一些情况下,电池112可以是可再充电的电池,其可以帮助增加LCP 100的可用寿命。在其他示例中,根据需要,电池110可以是一些其他类型的电源。
为了将LCP 100植入在患者体内,操作者(例如,医生、临床医生等)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(anchor)116。锚116可以包括多个固定机构或锚定机构中的任一个。例如,锚116可以包括一个或多个销、U形钉、螺纹、螺钉、螺旋、尖齿、和/或类似物。在一些示例中,虽然未示出,锚116可以包括在其外表面上的螺纹,其可以沿着锚116的至少部分长度行进。螺纹可以在心脏组织和锚之间提供摩擦以帮助将锚116固定在心脏组织内。在其他示例中,锚116可以包括其他结构,诸如倒钩、长钉等,以便于与周围的心脏组织接合。
图9描绘了另一医疗装置(MD)200的示例,其可以与LCP 100(图8)结合使用以便检测和/或治疗心脏异常。在一些情况下,MD 200可以被视为SICD 12(图1)的示例。在所示的示例中,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和电池218。这些模块中的每一个可以类似于LCP 100的模块102、104、106、108和110。另外地,电池218可以类似于LCP 100的电池112。然而,在一些示例中,MD200可以在外壳220内具有更大的容积。在这样的示例中,MD 200可以包括更大的电池和/或更大的处理模块210,其能够处理比LCP 100的处理模块110更复杂的操作。
虽然预期的是MD 200可以是如图8所示的另一无引线装置,但在某些情况下,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线。在一些情况下,引线212可以连接到MD 200的外壳220并且远离MD 200的外壳220延伸。在一些示例中,引线212被植入在患者的心脏上、其内部或其附近。引线212可以包含被定位在引线212上的不同位置处的并且在一些情况下可以距外壳220不同距离的一个或多个电极214。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被定位在引线212上,使得当引线212植入在患者内时,一个或多个电极214被定位以执行期望的功能。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。在一些情况下,一个或多个电极214可以被皮下定位和定位在患者心脏的外部。在一些情况下,电极214可以将内在生成的电信号传导到引线212,例如表示内在心电活动的信号。引线212继而可以将接收到的电信号传导到MD 200的模块202、204、206和208中的一个或多个。在一些情况下,MD 200可以生成电刺激信号,并且引线212可以将所生成的电刺激信号传导到电极214。电极214然后可以传导电信号并将信号递送到患者的心脏(直接或间接地)。
与机械感测模块108一样,机械感测模块208可以包含一个或多个传感器或电连接到一个或多个传感器,诸如加速度计、声学传感器、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机械/化学参数的其他传感器。在一些示例中,一个或多个传感器可以位于引线212上,但这并不要求。在一些示例中,一个或多个传感器可以位于外壳220中。
虽然不要求,但在一些示例中,MD 200可以是可植入医疗装置。在这样的示例中,MD 200的外壳220可以植入在例如患者的经胸廓区域中。外壳220通常可以包括许多已知材料中的任一种,其对植入在人体中是安全的并且当植入时,可以将MD 200的各种组件关于患者身体的流体和组织气密地密封。
在一些情况下,MD 200可以是可植入心脏起搏器(ICP)。在该示例中,MD 200可以具有一个或多个引线,例如引线212,其被植入患者的心脏上或其内。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可以被配置为经由心脏内植入的引线212来递送CRT、ATP治疗、心动过缓治疗和/或其他治疗类型。在一些示例中,MD 200可以另外地被配置为提供除颤治疗。
在一些情况下,MD 200可以是可植入复律器-除颤器(ICD)。在这样的示例中,MD200可以包括患者的心脏内植入的一个或多个引线。MD 200还可以被配置为感测心电信号,基于感测到的信号确定心律加快的发生,并且可以被配置为响应于确定心律加快的发生而递送除颤治疗。在其他示例中,MD 200可以是皮下可植入复律器-除颤器(S-ICD)。在MD 200是S-ICD的示例中,引线212中的一个可以是皮下植入式引线。在MD 200是S-ICD的至少一些示例中,MD 200可以仅包括皮下植入的单个引线,但这不要求。在一些情况下,一个或多个引线可以具有一个或多个电极,其皮下放置并被放置在胸腔的外部。在其他示例中,一个或多个引线可以具有一个或多个电极,其被放置在胸腔的内部,诸如正好在胸骨的内部。
在一些示例中,MD 200可以不是可植入医疗装置。相反,MD 200可以是患者身体外部的装置,并且可以包括在患者的身体上放置的皮肤电极。在这样的示例中,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在患者体内植入的装置生成并传导通过身体到达皮肤的电信号)。在这样的示例中,MD 200可以被配置为递送各种类型的电刺激治疗,包括例如除颤治疗。
图10示出了医疗装置系统和通信路径的示例,多个医疗装置302、304、306和/或310可以通过该通信路径进行通信。在所示的示例中,医疗装置系统300可以包括LCP 302和304、外部医疗装置306以及其他传感器/装置310。外部装置306可以是先前关于MD 200描述的任何装置。其他传感器/装置310也可以是先前关于MD 200描述的任何装置。在一些情况下,其他传感器/装置310可以包括传感器,诸如加速度计、声学传感器、血压传感器等。在一些情况下,其他传感器/装置310可以包括可以用于对系统300的一个或多个装置进行编程的外部编程器装置。
系统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可以感测内在心电信号并且可以经由通信路径308将这种信号传送到系统300的一个或多个其他装置302/304、306、和310。在一个示例中,装置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,确定心律失常的发生。在一些情况下,一个或多个装置302/304可以将这种确定传送到系统300的一个或多个其他装置306和310。在一些情况下,系统300的装置302/304、306和310中的一个或多个可以基于所传达的对心律失常的确定(诸如通过向患者的心脏递送合适的电刺激)而采取行动。预期的是通信路径308可以使用适合于通信的RF信号、电感耦合、光学信号、声学信号或任何其他信号进行通信。另外,在至少一些示例中,装置通信路径308可以包括多种信号类型。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LCP302/304通信。此外,在一些示例中,可以限制装置之间的通信。例如,如上所述,在一些示例中,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LCP302/304将信号发送到其他传感器/装置310,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,通信路径308可以包括传导通信。因此,系统300的装置可以具有允许这种传导通信的组件。例如,系统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,电流脉冲和/或电压脉冲)传输到患者的身体中,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(例如脉冲)。患者的身体可以将传导通信信号(例如脉冲)从系统300中的发送装置的一个或多个电极“传导”到接收装置的电极。在这样的示例中,所递送的传导通信信号(例如脉冲)可能与起搏或其他治疗信号不同。例如,系统300的装置可以以对心脏来说是亚阈值的幅度/脉冲宽度来递送电通信脉冲。虽然在某些情况下,所递送的电通信脉冲的幅度/脉冲宽度可以高于心脏的捕获阈值,但是可以在心脏的消隐时段(blanking period)期间被递送和/或可以并入或调制到起搏脉冲上(如果需要的话)。
可以以任何合适的方式调制所递送的电通信脉冲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的或幅度调制的。可替换地或另外地,可以调制脉冲之间的时间以编码期望的信息。在一些情况下,根据需要,所传导的通信脉冲可以是电压脉冲、电流脉冲、双相电压脉冲、双相电流脉冲、或任何其他合适的电脉冲。
图11示出了说明性医疗装置系统。在图11中,示出了LCP 402固定到心脏410的左心室的内部,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(S-ICD)的一部分,并且一个或多个电极408a-408c可以皮下定位。在一些情况下,一个或多个电极408a-408c可以放置在胸腔的内部但在心脏的外部,诸如正好在胸骨的内部。
在一些情况下,LCP 402可以与皮下可植入复律器-除颤器(S-ICD)通信。在一些情况下,引线412可以包括加速度计414,其可以例如被配置为感测可以指示心音的振动。
在一些情况下,根据需要,LCP 402可以在心脏的右心室、右心房、左心室或左心房中。在一些情况下,可以植入多于一个LCP 402。例如,一个LCP可以植入在右心室中,并且另一个可以植入在右心房中。在另一示例中,一个LCP可以植入在右心室中,并且另一个可以植入在左心室中。在又另一示例中,一个LCP可以植入在心脏的每个腔室中。
当LCP放置在例如左心室中,而没有LCP放置在左心房中时,本公开的技术可以用于帮助确定用于左心房的心房收缩定时基准。然后可以使用该心房收缩定时基准来确定经由LCP使左心室起搏的适当时间,诸如在心房收缩定时基准之后的A-V延迟。
图12是说明性可植入无引线心脏起搏器(LCP)610的侧视图。LCP 610在形式和功能上可以类似于上述LCP 100。LCP 610可以包括上面关于上述LCP100所描述的任何模块和/或结构特征。LCP 610可以包括具有近端614和远端616的壳体或外壳612。说明性LCP610包括:相对于外壳612固定的并且邻近外壳612的远端616而定位的第一电极620;以及相对于外壳612固定的并且邻近外壳612的近端614而定位的第二电极622。在一些情况下,外壳612可以包括导电材料并且可以沿着其长度的一部分绝缘。沿着近端614的区部可以不绝缘,以便限定第二电极622。电极620、622可以是感测电极和/或起搏电极,以提供电疗和/或感测能力。第一电极620可以能够抵靠心脏的心脏组织定位或者可以以其他方式接触心脏的心脏组织,同时第二电极622可以与第一电极620间隔开。第一电极和/或第二电极620、622可以暴露于外壳612外部的环境(例如血液和/或组织)。
在一些情况下,LCP 610可以包括外壳612内的脉冲发生器(例如,电路)和电源(例如,电池),以向电极620、622提供电信号以控制起搏电极/感测电极620、622。虽然未明确示出,但是LCP 610还可以包括通信模块、电感测模块、机械感测模块和/或处理模块,以及相关联的电路,其在形式和功能上类似于上述的模块102、106、108、110。各种模块和电路可以设置在外壳612内。脉冲发生器和电极620、622之间的电通信可以向心脏组织提供电刺激和/或感测生理状况。
在所示的示例中,LCP 610包括接近外壳612的远端616的固定机构624。固定机构624被配置为将LCP 610附接到心脏H的壁,或以其他方式将LCP 610锚定到患者的解剖结构。在一些情况下,固定机构624可以包括锚定到心脏H的心脏组织中以将LCP 610附接到组织壁的一个或更多或多个钩或尖齿626。在其他情况下,固定机构624可以包括:一个或更多或多个被动尖齿,其被配置为与心脏H的腔室内的骨小梁缠绕;和/或螺旋固定锚定件,其被配置为螺旋进入组织壁以将LCP 610锚定到心脏H。这些只是示例。
LCP 610还可以包括接近外壳612的近端614的对接构件(docking member)630。对接构件630可以被配置为便于LCP 610的递送和/或取回。例如,对接构件630可以从外壳612的近端614沿着外壳612的纵向轴线延伸。对接构件630可以包括头部632和在外壳612和头部632之间延伸的颈部634。头部632可以是相对于颈部634的扩大部分。例如,头部632可以具有距LCP 610的纵向轴线的径向尺寸,其大于颈部634距LCP 610的纵向轴线的径向尺寸。在一些情况下,对接构件630还可以包括从头部632延伸或凹入头部632内的系绳保持结构(tether retention structure)636。系绳保持结构636可以限定开口638,其被配置为接收通过其的系绳或其他锚定机构。虽然保持结构636被示出为具有大致“U形”配置,但是保持结构636可以采取以下任何形状,其提供围绕开口638的封闭周边,使得系绳可以固定地且可释放地穿过(例如,循环通过)开口638。在一些情况下,保持结构636可以沿着颈部634延伸通过头部632,并且延伸到外壳612的近端614或进入其内。对接构件630可以被配置为便于将LCP 610递送到心内部位和/或从心内部位取回LCP 610。虽然这描述了一个示例对接构件630,但是设想,当提供对接构件630时,其可以具有任何合适的配置。
预期的是LCP 610可以包括一个或多个压力传感器640,其耦合到外壳612或在外壳612内形成,使得一个或多个压力传感器暴露于外壳612外部的环境以测量心脏内的血压。例如,如果LCP 610放置在左心室中,则一个或多个压力传感器640可以测量左心室内的压力。如果LCP 610放置在心脏的另一部分(诸如心房或右心室中的一个)中,则一个或多个压力传感器可以测量心脏的该部分内的压力。一个或多个压力传感器640可以包括MEMS装置(诸如具有压力膜片和膜片上的压电电阻器的MEMS装置)、压电传感器、电容器-微机械加工的超声换能器(cMUT)、电容器(condenser)、微型测压计、或适于测量心脏压力的任何其他合适的传感器。一个或多个压力传感器640可以是本文所述的机械感测模块的一部分。预期的是从一个或多个压力传感器640获得的压力测量值可以用于生成相对于心动周期的压力曲线。压力读数可以与阻抗测量值(例如,电极620和622之间的阻抗)进行组合来取得以生成用于一个或多个心动周期的压力-阻抗环,如下面将更详细描述的。阻抗可以是腔室容积的代理,且因此压力-阻抗环可以表示心脏H的压力-容积环。
在一些实施例中,LCP 610可以被配置为测量电极620、622之间的阻抗。更一般地,可以测量其他电极对(诸如上述附加电极114')之间的阻抗。在一些情况下,可以测量两个间隔开的LCP、诸如心脏H的相同腔室(例如LV)内植入的两个LCP、或者心脏H的不同腔室(例如RV和LV)中植入的两个LCP之间的阻抗。LCP 610的处理模块和/或外部支持装置可以从电极620、622(或其他电极)之间进行的心内阻抗测量导出心脏容积的测度。主要由于血液的电阻率和心脏H的心脏组织的电阻率的差异,因此当LCP周围的血液容积(和因此腔室的容积)变化时,阻抗测量值在心动周期期间可能变化。在一些情况下,心脏容积的测度可以是相对测度,而不是实际测度。在一些情况下,心内阻抗可以通过有时在一个或多个LCP的植入期间执行的校准过程与心脏容积的实际测度相关。在校准过程期间,可以使用荧光检查等确定实际心脏容积,并且测量到的阻抗可以与实际心脏容积相关。
在一些情况下,LCP 610可以设置有能量递送电路,其可操作地耦合到第一电极620和第二电极622,以用于致使电流在第一电极620和第二电极622之间流动,以便确定两个电极620、622(或其他电极对)之间的阻抗。预期的是能量递送电路还可以被配置为经由第一电极和/或第二电极620、622递送起搏脉冲。LCP 610还可以包括检测电路,其可操作地耦合到第一电极620和第二电极622以用于检测在第一电极620和第二电极622之间接收到的电信号。在一些情况下,检测电路可以被配置为检测在第一电极620和第二电极622之间接收到的心脏信号。
当能量递送电路在第一电极620和第二电极622之间递送电流时,检测电路可以测量第一电极620和第二电极622之间(或者与第一电极620和第二电极622分离的第三电极和第四电极之间)所产生的电压以确定阻抗。当能量递送电路在第一电极620和第二电极622之间递送电压时,检测电路可以测量第一电极620和第二电极622之间(或者与第一电极620和第二电极622分离的第三电极和第四电极之间)所产生的电流以确定阻抗。
在一些情况下,可以在不同装置上和/或不同心脏腔室中的电极之间测量阻抗。例如,可以在左心室中的第一电极和右心室中的第二电极之间测量阻抗。在另一示例中,可以在左心室中的第一LCP的第一电极和左心室中的第二LCP的第一电极之间测量阻抗。在又另一示例中,可以从注入的电流测量阻抗。例如,医疗装置(诸如但不限于诸如图1的SICD 12的SICD)可以将已知的电流注入到心脏中,并且心脏H中植入的LCP可以测量注入电流所产生的电压来确定阻抗。这些只是一些示例。
图13示出了表示压力-容积(PV)环中心脏的压力和容积参数的方法。PV环可以用于确定心脏H的性能特性。说明性PV环700示出了心脏的左心室的正常PV特性。PV环700以逆时针方向移动。二尖瓣在704处打开并且心室充盈沿着702发生。心室充盈702在点706处终止并且二尖瓣闭合。二尖瓣的闭合在706处引起S1心音。点706表示在心脏的扩张阶段结束时心脏的舒张末期容积(EDV)或血容量。心室在706处收缩。在主动脉瓣在710处打开之前,沿着708发生等容收缩阶段,其中心室压力快速增加但心室容积不会显著改变。射血阶段712从点710持续直到主动脉瓣在点714处关闭为止。在点714处主动脉瓣的闭合生成S2心音,并且在心脏的收缩阶段结束时还标记心脏的收缩末期容积(ESV)或血容量。等容舒张阶段716在点714处开始并持续直到二尖瓣在点704处打开为止并且心动周期重复。在一些情况下,例如,如果点704、706、710和714(PV环的四个“拐角”)是已知的,则可以近似PV环700。
收缩性指数表示肌肉响应于合适的刺激而变短的能力。可以通过计算收缩末期压力-容积线的斜率(如718所示)来估计收缩性指数的测度。可以通过PV环700的面积来估计搏出功(stroke work)的测度。心搏量(stroke volume)的测度可以通过EDV减去ESV来估计,并且表示每次心跳时从心脏射出的血液量。可以通过心搏量除以EDV来估计射血分数(在心脏收缩期间射出的心脏舒张末期时心室中血容量的比例)的测度。这些仅是说明性的,并且预期的是也可以从PV环700提取或导出其他参数。
图14是示出了使用在左心室LV内设置的LCP生成心室脉冲的说明性方法800的流程图。在一些情况下,如框802所示,可以感测指示患者心脏的心房收缩的第一信号。如框804所示,还可以感测与患者心脏的心房收缩有关的第二不同信号。在一些情况下,可以通过LCP内的压力传感器生成第一信号和/或第二信号。在一些情况下,与患者心脏的心房收缩有关的第二信号可以包括在患者心脏的心房收缩之后对患者心脏的心室收缩的指示。如框806所示,控制器可以至少部分地基于指示患者心脏的心房收缩的感测到的第一信号以及与患者心脏的心房收缩有关的感测到的第二信号来确定心房收缩定时基准。如框808所示,可以使用心房收缩定时基准生成并递送心室起搏脉冲。
图15是示出了使用在左心室LV内设置的LCP生成和递送心室脉冲的另一说明性方法810的流程图。如在框812处一般指示的,可以感测表示心脏性能的信号。如框814所示,可以针对心动周期确定定时基准。如框816所示,可以至少部分地基于表示心脏性能的感测到的信号,相对于定时基准而调整起搏时间。如框818所示,可以在心动周期中的起搏时间处生成并递送心室起搏脉冲。在心室起搏脉冲之后,方法810可以包括感测表示心脏性能的信号以确定是否使用调整后的起搏时间改善心脏性能,如框820所示。
图16是示出了使用在左心室LV内设置的LCP来确定心室起搏时间的说明性方法822的流程图。如框824所示,可以确定或接收对代谢需求的指示。在判定框826处,确定对代谢需求的指示是否超过阈值。如果是,则控制转到框828,并且可以确定实现较低的被动心室充盈的心室起搏时间。如果不是,则控制转到框830,并且可以确定实现较高的被动心室充盈的心室起搏时间。在一些情况下,被动心室充盈的测度至少部分地基于来自LCP内的压力传感器的压力信号。
本技术的技术人员将认识到,本公开可以以除了本文描述和考虑的特定示例之外的各种形式来表明。例如,如本文所述,各种示例包括被描述为执行各种功能的一个或多个模块。然而,其他示例可以包括附加模块,其将所述的功能分开到比本文所述模块更多的模块上。另外,其他示例可以将所述功能合并为更少的模块。因此,在不脱离如所附权利要求中描述的本公开的范围和精神的情况下,可以在形式和细节上进行偏离。
Claims (15)
1.一种无引线心脏起搏器(LCP),被配置为感测心脏活动并起搏患者的心脏,LCP在患者心脏的心室内是能任意放置的,所述LCP包括:
外壳;
相对于所述外壳固定的第一电极;
相对于所述外壳固定的第二电极,所述第二电极与所述第一电极间隔开;
控制器,所述控制器被设置在所述外壳内并且可操作地耦合到所述第一电极和所述第二电极,使得所述控制器能够经由所述第一电极和所述第二电极接收心脏的心电信号;
压力传感器,所述压力传感器相对于外壳而设置并且可操作地耦合到所述控制器,所述控制器被配置为从所述压力传感器接收信号;
加速度计,所述加速度计相对于所述外壳而设置并且可操作地耦合到所述控制器,所述控制器被配置为从所述加速度计接收信号;
所述控制器被配置为至少部分地基于以下信号中的两个或更多个来确定心房收缩定时基准:从所述压力传感器接收到的信号;从所述加速度计接收到的表示心音和/或心内膜加速度的信号;以及经由所述第一电极和所述第二电极接收到的心电信号;并且
所述控制器被配置为使用所述心房收缩定时基准来生成并递送心室起搏脉冲。
2.根据权利要求1所述的LCP,其中,所述控制器被配置为至少部分地基于从所述压力传感器接收到的信号和从所述加速度计接收到的信号来确定所述心房收缩定时基准。
3.根据权利要求1所述的LCP,其中,所述控制器被配置为至少部分地基于从所述压力传感器接收到的信号和经由所述第一电极和所述第二电极接收到的心电信号来确定所述心房收缩定时基准。
4.根据权利要求1所述的LCP,其中,所述控制器被配置为至少部分地基于从所述压力传感器接收到的信号中的感测到的A波和从所述加速度计接收到的信号中的S4心音相关联的感测到的信号来确定所述心房收缩定时基准。
5.根据权利要求1至4中任一项所述的LCP,其中,从所述压力传感器接收到的信号包括:
心室压力相对于时间的变化(dP/dt);和/或
A波;和/或
脉冲压力。
6.根据权利要求1至5中任一项所述的LCP,其中,从所述加速度计接收到的信号包括心音信号或心内膜加速度信号。
7.根据权利要求1至6中任一项所述的LCP,其中,经由所述第一电极和所述第二电极接收到的心电信号包括心电图(ECG)的至少一部分。
8.根据权利要求7所述的LCP,其中,经由所述第一电极和所述第二电极接收到的心电信号包括P波。
9.根据权利要求7所述的LCP,其中,经由所述第一电极和所述第二电极接收到的心电信号包括QRS波群,从其能够确定QRS宽度。
10.根据权利要求7所述的LCP,其中,经由所述第一电极和所述第二电极接收到的心电信号包括两个连续的R波,从其能够确定R波到R波间隔。
11.一种无引线心脏起搏器(LCP),被配置为感测心脏活动并起搏患者的心脏,LCP在患者心脏的心室内是能任意放置的,所述LCP包括:
外壳;
相对于所述外壳固定的第一电极;
相对于所述外壳固定的第二电极,所述第二电极与所述第一电极间隔开;
控制器,所述控制器被设置在所述外壳内并且可操作地耦合到所述第一电极和所述第二电极,使得所述控制器能够经由所述第一电极和所述第二电极从心脏接收心电信号;
所述控制器还被配置为至少部分地基于以下指示来确定心房收缩定时基准:第一心跳中的心房收缩的感测到的指示;以及第一心跳、紧接在前心跳和/或紧接在后心跳中的心室收缩的感测到的指示;并且
所述控制器还被配置为使用所述心房收缩定时基准来生成并递送心室起搏脉冲。
12.根据权利要求11所述的LCP,还包括压力传感器,所述压力传感器相对于所述外壳而设置并且可操作地耦合到所述控制器。
13.根据权利要求11或12中任一项所述的LCP,还包括加速度计,所述加速度计相对于所述外壳而设置并且可操作地耦合到所述控制器。
14.根据权利要求11至13中任一项所述的LCP,其中,提供心房收缩的指示的第一信号包括S3心音信号、S4心音信号、A波信号和/或P波信号中的一个或多个。
15.根据权利要求11至14中任一项所述的LCP,其中,提供心室收缩的指示的第二信号包括脉压信号、dP/dt信号、R波到R波间隔、QRS波群宽度、和/或心室压力-容积环参数中的一个或多个。
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EP3487579B1 (en) | 2020-11-25 |
US20180021581A1 (en) | 2018-01-25 |
EP3487579A1 (en) | 2019-05-29 |
US10688304B2 (en) | 2020-06-23 |
WO2018017226A1 (en) | 2018-01-25 |
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