CN115335116A - 心脏传导系统疗法益处确定 - Google Patents
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Abstract
本文描述了用于确定心脏传导系统起搏疗法是否可能有益和/或使用外部心脏信号确定心脏传导系统阻滞可能多近或多远的系统和方法。为此,可以基于使用多个左外部电极测量的左侧替代心脏电来生成电异质性信息的一个或多个左侧度量。
Description
本文的公开涉及用于使用多个外部电极确定心脏传导系统疗法益处的系统和方法。
植入式医疗装置(IMD),如植入式起搏器、心脏复律器、除颤器或起搏器-心脏复律器-除颤器,为心脏提供治疗性电刺激。IMD可以提供起搏以解决心动过缓,或提供起搏或电击以终止如心动过速或纤颤等快速性心律失常。在一些情况下,医疗装置可以感测心脏的固有去极化,基于固有去极化(或不存在)检测心律失常,并且如果基于固有去极化检测到心律失常,则控制向心脏递送电刺激。
IMD还可以提供心脏再同步疗法(CRT),这是一种起搏形式。CRT涉及向左心室或左右心室两者递送起搏。可以选择向心室递送起搏脉冲的定时和位置以改进心室收缩的协调性和效率。
IMDS可以被描述为递送常规起搏疗法和心脏传导系统起搏疗法中的一种或两种。常规或传统起搏疗法可以被描述为将起搏脉冲递送到不是患者心脏的心脏传导系统的一部分的心肌组织中,使得例如电激活从一个心肌细胞传播到另一个心肌细胞(也被称为“细胞到细胞”)。例如,常规起搏疗法可以将起搏脉冲直接递送到要去极化以提供心脏收缩的肌肉心脏组织中。例如,常规左心室起搏疗法可以利用植入的左心室(LV)冠状窦引线以延伸通过一个或多个静脉、腔静脉、右心房并进入到冠状窦中到达与心脏的左心室的游离壁相邻的区域,以将起搏脉冲递送到左心室的游离壁的心肌组织。
心脏传导系统起搏疗法可以被描述为将起搏脉冲递送到心脏传导系统中。更具体地,心脏传导系统起搏疗法可以包含心脏传导系统的一个或多个部分,如左束支、希氏束、房室结、右束支等。例如,心房至心室(VfA)引线可以将起搏脉冲直接递送到心脏传导系统的左束支,使得脉冲沿左束支和浦肯野纤维(Purkinje fiber)传播,从而启动脉冲附近的心脏组织(例如,左心室的心肌组织)的去极化。
除了植入式医疗装置本身之外,用于植入医疗装置的系统还可以包含工作站或其它设备。在一些情况下,设备的这些其它设备辅助医师或其它技术人员将心内引线放置在心脏上的特定位置处。在一些情况下,设备向医师提供关于心脏电活动和心内引线位置的信息。设备可以执行与医疗装置类似的功能,包含向心脏递送电刺激和感测心脏的去极化。在一些情况下,设备可以包含用于经由患者表面或皮肤上的电极获得心电图(ECG)的设备。更具体地,患者可以具有围绕患者躯干的ECG腰带或背心上的多个电极。在腰带或背心已经固定到躯干后,医师可以执行一系列测试来评估患者的心脏反应。评估过程可以包含检测其中没有向心脏组织递送电刺激的基线节律以及在向心脏组织递送电刺激之后的另一个节律。
被放置在患者的身体表面上的ECG电极可以用于各种治疗目的(例如,心脏再同步治疗),包含基于从由ECG电极捕获的信号中导出的一个或多个度量来优化引线位置、起搏参数等。
发明内容
本文所述的示例性系统和方法可以被配置成在植入和配置心脏疗法设备以执行心脏传导系统起搏疗法和常规心脏起搏疗法中的一者或两者之前帮助用户(例如,医师、临床医生、医生等)确定患者是否可以受益于心脏传导系统疗法。因此,说明性系统和方法可以在患者心脏的固有激活(例如,没有任何心脏疗法被递送给患者并且允许患者的心脏自然跳动)期间执行。进一步地,所述系统和方法可以被描述为是无创的。例如,所述系统和方法可能不使用如引线、探针、传感器、导管等植入式装置来评估患者是否可以受益于心脏传导系统疗法或者确定心脏传导系统阻滞的位置或定位。相反,所述系统和方法可以使用无创地使用例如附接到患者躯干周围的患者的皮肤的多个外部电极而获得的电测量结果。
一种说明性系统可以包含电极设备和耦接到所述电极设备的计算设备。电极设备可以包含靠近患者皮肤安置的多个外部电极,并且所述多个外部电极可以包含定位于患者躯干左侧的多个左外部电极。计算设备可以包含处理电路系统,并且被配置成在患者心脏的固有激活期间使用电极设备的多个外部电极来测量替代心脏电激活时间。替代心脏电激活时间可以表示传播穿过患者躯干的心脏组织去极化。计算设备可以被进一步配置成基于测得的替代心脏电激活时间来生成电异质性信息(EHI)。EHI可以包含基于使用多个左外部电极测量的替代心脏电激活时间的左侧激活时间生成的一个或多个左度量。计算设备可以被进一步配置成至少基于所述一个或多个左度量来确定心脏传导系统起搏疗法是否将有益于患者。
一种说明性方法可以包含在患者心脏的固有激活期间使用靠近患者皮肤安置的多个外部电极测量替代心脏电激活时间。所述多个外部电极可以包含定位于患者躯干左侧的多个左外部电极,并且所述替代心脏电激活时间可以表示传播穿过患者躯干的心脏组织去极化。说明性方法可以进一步包含基于测得的替代心脏电激活时间生成电异质性信息(EHI)。EHI可以包含基于使用多个左外部电极测量的替代心脏电激活时间的左侧激活时间生成的一个或多个左度量。说明性方法可以进一步包含至少基于所述一个或多个左度量来确定心脏传导系统起搏疗法是否将有益于患者。
一种说明性系统可以包含电极设备和耦接到所述电极设备的计算设备。电极设备可以包含靠近患者皮肤安置的多个外部电极,并且所述多个外部电极可以包含定位于患者躯干左侧的多个左外部电极。计算设备可以包含处理电路系统,并且被配置成在患者心脏的固有激活期间使用电极设备的多个外部电极来测量替代心脏电激活时间。替代心脏电激活时间可以表示传播穿过患者躯干的心脏组织去极化。计算设备可以被进一步配置成基于测得的替代心脏电激活时间来生成电异质性信息(EHI)。EHI可以包含基于使用多个左外部电极测量的替代心脏电激活时间的左侧激活时间生成的一个或多个左度量。计算设备可以被进一步配置成至少基于所述一个或多个左度量来确定心脏传导系统阻滞是否沿患者的心脏传导网络相比于远侧区域更靠近近侧区域。患者的心脏传导系统可以从位于患者的窦房结或房室结附近的近侧区域延伸到位于患者的浦肯野纤维附近的远侧区域。
一种说明性系统可以包含电极设备、显示器以及耦接到所述电极设备和所述显示器的计算设备。电极设备可以包含靠近患者皮肤安置的多个外部电极,并且所述多个外部电极可以包含定位于患者躯干左侧的多个左外部电极。显示器可以包含图形用户界面以呈现用于帮助用户评估患者是否将受益于心脏传导系统起搏疗法的信息。计算设备可以包含处理电路系统并且被配置成:允许用户在图形用户界面上启动心脏传导系统起搏疗法益处确定,并且响应于用户启动所述心脏传导系统起搏疗法益处确定在患者心脏的固有激活期间使用电极设备的多个外部电极测量替代心脏电激活时间。替代心脏电激活时间可以表示传播穿过患者躯干的心脏组织去极化。计算设备可以被进一步配置成基于测得的替代心脏电激活时间来生成电异质性信息(EHI)。EHI可以包含基于使用多个左外部电极测量的替代心脏电激活时间的左侧激活时间生成的一个或多个左度量。计算设备可以被进一步配置成在图形用户界面上显示至少基于所述一个或多个左度量的对心脏传导系统起搏疗法是否将有益于患者的指示。
在至少一个实施例中,说明性系统和方法可以确定在身体左侧的晚期激活电极(例如,以从患者前部的胸骨环绕到患者后部的脊柱左侧的阵列定位在患者皮肤上的外部电极)的百分比,以估计固有节律期间左心室激活延迟的程度(例如,由于左束支阻滞(LBBB))。例如,相对于最早检测到的替代心脏激活除以左侧上的外部电极总数,患者左侧有多少个外部电极在某个时间阈值(例如,40毫秒(ms)、50ms等)之后监测替代心脏激活可以用百分比表示。如果百分比大于或等于百分比阈值(例如,40%、50%、60%等)和/或左侧电极(LVAT)的平均激活时间大于或等于某个阈值(例如,40ms、50ms、60ms等),则左束中的阻滞可能更靠近近侧并且此类患者可以通过近侧传导系统起搏疗法来纠正,并且因此,患者将是在植入手术期间(例如,在对如肌肉心脏组织等心脏传导系统之外的心脏区域进行常规起搏之前)尝试传导系统起搏的候选者。相反,如果百分比小于百分比阈值和/或LVAT小于某个阈值,则左束中的阻滞可能更靠近远侧,这可能无法通过近侧传导系统起搏来纠正。
因此,可以描述说明性系统和方法可以提供筛选系统,以在植入心脏传导系统起搏设备的任何有创手术之前基于固有ECG图和从其导出的度量来确定哪些患者可能受益于心脏传导系统起搏。
以上概述不旨在描述本公开的每个实施例或每个实施方案。通过结合附图参考以下详细描述和权利要求,更完整的理解将变得显而易见和易于理解。
附图说明
图1是包含电极设备、显示设备和计算设备的示例性系统的图。
图2-3是用于监测电活动(例如,躯干表面电势、替代心脏电激活时间等)的示例性外部电极设备的图。
图4A描绘了包含定位在房室结与希氏束之间的心脏传导系统阻滞的患者的心脏传导网络。
图4B描绘了包含定位在左分支中的心脏传导系统阻滞的患者的心脏传导网络。
图5A是用于确定患者是否可以受益于心脏传导系统起搏疗法的说明性方法的框图。
图5B是图5A中描绘的方法的说明性方法的详细框图。
图6A展示了后来接受希氏束起搏的患者的固有心脏电数据的条形图。
图6B展示了两名患者的固有或基线激活以及希氏束起搏期间的前部和后部激活图。
图7是包含植入在患者心脏中的心内医疗装置和定位在患者心脏外部的单独的医疗装置的说明性心脏疗法系统的概念图。
图8是图7的心内医疗装置和患者心脏的解剖结构的放大概念图。
图9是用于与本文所述的说明性系统和装置一起使用的示出了各种电极植入位置的左心室的标准17段视图中患者的心脏图的概念图。
图10是可以围封在例如图7-8的医疗装置的壳体内以提供本文所述的功能和疗法的说明性电路系统的框图。
具体实施方式
在以下对说明性实施例的详细描述中,对形成详细描述的一部分的附图进行参考,并且在附图中通过说明的方式示出了可以实践的具体实施例。应理解,在不脱离(例如,仍然落入)特此呈现的本公开的范围的情况下,可以利用其它实施例,并且结构范围可以改变。
应参考图1-10描述说明性系统和方法。对于本领域技术人员来说将显而易见的是,来自一个实施例的元件或过程可以与其它实施例的元件或过程组合使用,并且使用本文所阐述的特征的组合的此类系统和方法的可能实施例不限于图中所示和/或本文所述的具体实施例。进一步地,将认识到本文所述的实施例可以包含许多不一定按比例示出的元件。仍进一步地,将认识到,本文中的过程的定时和各个元件的大小和形状可以被修改但仍落入本公开的范围内,但是某些定时、一个或多个形状和/或大小或者元件类型可能优于其它定时、一个或多个形状和/或大小或者元件类型。
可以使用定位在患者的表面或皮肤周围的多个外部电极来测量或监测多个心电图(ECG)信号(例如,躯干表面电势)。ECG信号可以用于评估患者的心脏健康状况,以确定患者是否可以受益于心脏传导起搏疗法和/或另一种心脏治疗,以及确定心脏传导系统阻滞的位置或相对定位。如本文所述,可以无创地采集或获得ECG信号,因为例如植入式电极可以不用于测量ECG信号。进一步地,ECG信号可以用于确定心脏电激活时间,所述心脏电激活时间可以用于生成各种度量(例如,电异质性信息),用户(例如,医师)可以使用这些度量来确定患者是否可以受益于心脏起搏疗法,例如,心脏传导系统起搏疗法和/或常规起搏疗法。
各种说明性系统、方法和图形用户界面可以被配置成使用包含外部电极的电极设备、显示设备和计算设备来无创地帮助用户(例如,医师)评估心脏健康状况、确定心脏传导系统阻滞的位置以及确定患者是否可以受益于心脏传导系统起搏疗法和/或其它类型的心脏疗法。图1中描绘了包含电极设备110、计算设备140和远程计算装置160的说明性系统100。
如图所示的电极设备110包含多个电极,所述多个电极并入或包含在缠绕在患者14的胸部或躯干周围的绑带内。电极设备110操作性地耦接到计算设备140(例如,通过一个或有线电连接、无线地等)以将来自所述电极中的每个电极的电信号提供给计算设备140进行分析、评估等。说明性电极设备可以在于2014年3月27日提交的并且于2016年3月26日发布的题为“生物电传感器装置和方法(Bioelectric Sensor Device and Methods)”的美国专利第9,320,446号以及于2020年1月6日提交的题为“生物电传感器装置和方法(Bioelectric Sensor Device and Methods)”的美国临时专利申请序列号62/957,449中描述,所述专利申请中的每一个通过引用整体并入本文。进一步地,将参考图2-3更详细地描述说明性电极设备110。
尽管在本文中未进行描述,但是说明性系统100可以进一步包含成像设备。成像设备可以是被配置成以无创方式对患者的至少一部分进行成像或提供患者的至少一部分的图像的任何类型的成像设备。例如,除了如造影溶液等无创工具之外,成像设备可以不使用可以位于患者体内的任何组件或部件来提供患者的图像。应当理解,本文所述的说明性系统、方法和接口可以进一步使用成像设备来向用户(例如,医师)提供无创辅助,以结合心脏疗法的配置将一个或多个起搏电极定位或放置在患者的心脏附近。
例如,说明性系统和方法可以提供图像引导导航,所述图像引导导航可以用于在患者体内导航包含电极、无引线电极、无线电极、导管等引线,同时还提供无创心脏疗法配置,包含确定有效的或最佳的预激励间期,如A-V间期和V-V间期等。使用成像设备和/或电极设备的说明性系统和方法可以描述于以下文献中:Ghosh的于2018年1月30日发布的美国专利第9,877,789B2号、Ghosh等人的于2019年4月9日发布的美国专利第10,251,555B2号、Ghosh等人的于2018年3月27日发布的美国专利第9,924,884B2号、Ghosh等人的于2018年9月4日发布的美国专利第10,064,567B2号。
说明性成像设备可以被配置成捕获x射线图像和/或任何其它替代性成像模态。例如,成像设备可以被配置成使用等中心荧光透视、双平面荧光透视、超声、计算机断层扫描(CT)、多层计算机断层扫描(MSCT)、磁共振成像(MRI)、高频超声(HIFU)、光学相干断层扫描(OCT)、血管内超声(IVUS)、二维(2D)超声、三维(3D)超声、四维(4D)超声、术中CT、术中MRI等来捕获图像或图像数据。进一步地,应当理解,成像设备可以被配置成捕获多个连续图像(例如,连续地)以提供视频帧数据。换句话说,使用成像设备随时间拍摄的多个图像可以提供视频帧数据或运动图片数据。采用超声的示例性系统可见于Stadler等人的题为《心脏再同步疗法的无创性评估(NONINVASIVE ASSESSMENT OF CARDIAC RESYNCHRONIZATIONTHERAPY)》的美国专利申请公开第2017/0303840号。另外,还可以获得并且以二维、三维或四维显示图像。在更高级的形式中,还可以通过并入来自图或来自通过MRI、CT或回声心动描计术模态捕获的术前图像数据的心脏数据或其它软组织数据来实现心脏或身体其它区域的四维表面渲染。来自混合模态的图像数据集,如与CT组合的正电子发射断层扫描(PET)或与CT组合的单光子发射计算机断层扫描(SPECT)还可以提供叠加在解剖数据上的,例如以用于将植入式设备导航到心脏或所关注的其它区域内的目标位置的功能图像数据。
可以与本文所述的说明性系统和方法结合使用的系统和/或成像设备描述于Evron等人的于2005年1月13日公开的美国专利申请公开第2005/0008210号、Zarkh等人的于2006年4月6日公开的美国专利申请公开第2006/0074285号、Zarkh等人的于2014年5月20日发布的美国专利第8,731,642号、Brada等人的于2014年10月14日发布的美国专利第8,861,830号、Evron等人的于2005年12月27日发布的美国专利第6,980,675号、Okerlund等人的于2007年10月23日发布的美国专利第7,286,866号、Reddy等人的于2011年12月11日发布的美国专利第7,308,297号、Burrell等人的于2011年12月11日发布的美国专利第7,308,299号、Evron等人的于2008年1月22日发布的美国专利第7,321,677号、Okerlund等人的于2008年3月18日发布的美国专利第7,346,381号、Burrell等人的于2008年11月18日发布的美国专利第7,454,248号、Vass等人的于2009年3月3日发布的美国专利第7,499,743号、Okerlund等人的于2009年7月21日发布的美国专利第7,565,190号、Zarkh等人的于2009年9月8日发布的美国专利第7,587,074号、Hunter等人的于2009年10月6日发布的美国专利第7,599,730号、Vass等人的于2009年11月3日发布的美国专利第7,613,500号、Zarkh等人的于2010年6月22日发布的美国专利第7,742,629号、Okerlund等人的于2010年6月29日发布的美国专利第7,747,047号、Evron等人的于2010年8月17日发布的美国专利第7,778,685号、Vass等人的于2010年8月17日发布的美国专利第7,778,686号、Okerlund等人的于2010年10月12日发布的美国专利第7,813,785号、Vass等人的于2011年8月9日发布的美国专利第7,996,063号、Hunter等人的于2011年11月15日发布的美国专利第8,060,185号以及Verard等人的于2013年3月19日发布的美国专利第8,401,616号。
计算设备140和远程计算装置160可以各自分别包含显示设备130、170,所述显示设备可以被配置成显示和分析数据,例如,电信号(例如,心电图数据)、电激活时间、电异质性信息等。例如,可以分析和评估由电极设备110收集或监测的电信号所表示的多个心动周期或心跳中的一个心动周期或一次心跳的一个或多个度量,所述一个或多个度量包含可能与确定心脏传导系统阻滞在患者的心脏传导网络内的位置或相对定位以及确定患者是否将受益于一种或多种如心脏传导系统起搏疗法等不同类型的心脏疗法有关的替代心脏电激活时间和电异质性信息。另外,此类替代心脏电激活时间和电异质性信息还可能与一个或多个例如起搏参数、引线位置等与心脏疗法有关的参数的治疗性质有关,并且因此,可能对其调整有用。更具体地,例如,可以评估单个心动周期的QRS复合波的一个或多个度量,例如,QRS开始、QRS偏移、QRS峰值、电异质性信息(EHI)、参考最早激活时间的电激活时间、左侧激活时间的左侧晚期激活百分比、左心室或胸电激活时间的标准偏差(LVED)、激活时间的标准偏差(SDAT)、平均左心室或胸替代心脏电激活时间(LVAT)、QRS持续时间(例如,QRS开始到QRS偏移之间的间期)、平均左替代激活时间与平均右替代激活时间之间的差异、相对或绝对QRS形态、激活时间的较高百分位数与较低百分位数之间的差异(较高百分位数可以是90%、80%、75%、70%等并且较低百分位数可以是10%、15%、20%、25%和30%等)、其它集中趋势的统计量度(例如,中值或众数)、离差(例如,平均偏差、标准偏差、方差、四分位差、范围)等。进一步地,所述一个或多个度量中的每个度量可以是位置特定的。例如,一些度量可以根据从围绕患者的所选区域(例如,患者的左侧、患者的右侧等)定位的电极记录或监测的信号来计算。
在至少一个实施例中,计算设备140和远程计算装置160中的一者或两者可以是服务器、个人计算机、平板电脑、移动设备和蜂窝电话。计算设备140可以被配置成从输入设备142(例如,键盘)接收输入并将输出传输到显示设备130,并且远程计算装置160可以被配置成从输入设备162(例如,触摸屏)接收输入并将输出传输到显示设备170。计算设备140和远程计算装置160中的一者或两者可以包含可以允许访问处理程序或例程和/或一种或多种其它类型的数据的数据存储装置,例如,用于分析由电极设备110捕获的多个电信号,用于确定QRS开始、QRS偏移、中值、众数、平均值、峰值或最大值、谷值或最小值,用于确定电激活时间,用于驱动被配置成无创地帮助用户确定患者是否可以受益于心脏传导系统起搏疗法和/或另一种心脏疗法的图形用户界面,用于驱动被配置成无创地帮助用户确定心脏传导系统阻滞的位置或相对定位的图形用户界面,用于驱动被配置成无创地帮助用户配置一个或多个起搏参数或设置的图形用户界面,所述一个或多个参数或设置例如是起搏速率、心室起搏速率、A-V间期、V-V间期、起搏脉冲宽度、起搏矢量、多点起搏矢量(例如,左心室矢量四引线)、起搏电压、起搏配置(例如,双心室起搏、仅右心室起搏、仅左心室起搏等)以及心律失常检测和治疗、心率自适应设置和性能等。
计算设备140可以操作性地耦接到输入设备142和显示设备130以例如向输入设备142和显示设备130中的每个设备传输数据并从所述设备传输数据,并且远程计算装置160可以操作性地耦接到输入设备162和显示设备170以例如向输入设备162和显示设备170中的每个设备传输数据并从所述设备传输数据。例如,计算设备140和远程计算装置160可以使用例如模拟电连接、数字电连接、无线连接、基于总线的连接、基于网络的连接、基于互联网的连接等来电耦接到输入设备142、162和显示设备130、170。如本文进一步描述的,用户可以向输入设备142、162提供输入,以便查看和/或选择与由心脏疗法设备,如例如植入式医疗装置递送的心脏疗法相关的一条或多条配置信息。
尽管如所描绘的输入设备142是键盘并且输入设备162是触摸屏,但是应当理解,输入设备142、162可以包含能够向计算设备140和计算装置160提供输入以执行本文所述的功能、方法和/或逻辑的任何设备。例如,输入设备142、162可以包含键盘、鼠标、跟踪球、触摸屏(例如,电容式触摸屏、电阻式触摸屏、多点触摸式触摸屏等)等。同样,显示设备130、170可以包含能够向用户显示信息的任何设备,如图形用户界面132、172,所述信息包含电极状态信息、电激活的图形图、对患者是否可以受益于心脏传导系统起搏疗法和/或另一种心脏疗法的指示、心脏传导系统阻滞可能位于患者的心脏传导网络内的位置、外部电极在一个或多个心跳上的多个信号、QRS复合波、各种心脏疗法方案选择区域、各种心脏疗法方案排名、各种起搏参数、电异质性信息(EHI)、文本指令、人类心脏的解剖结构的图形描绘、患者心脏的图像或图形描绘、一个或多个电极的位置的图形描绘、人体躯干的图形描绘、患者躯干的图像或图形描绘、患者的心脏传导网络和位于其中的任何心脏传导系统阻滞的图形描绘、植入的电极和/或引线的图形描绘或实际图像等。进一步地,显示设备130、170可以包含液晶显示器、有机发光二极管屏幕、触摸屏、阴极射线管显示器等。
由计算设备140和远程计算装置160存储和/或执行的处理程序或例程可以包含用于计算数学、矩阵数学、分解算法、压缩算法(例如,数据压缩算法)、校准算法、图像构造算法、信号处理算法(例如,各种过滤算法、傅立叶变换、快速傅立叶变换等)、标准化算法、比较算法、向量数学或实施本文所述的一个或多个说明性方法和/或过程的任何其它处理的程序或例程。由计算设备140和远程计算装置160存储和/或使用的数据可以包含例如来自电极设备110的电信号/波形数据(例如,多个QRS复合波)、来自电极设备110的电激活时间、来自声学传感器的心音/信号/波形数据、图形(例如,图形元素、图标、按钮、窗口、对话框、下拉菜单、图形区、图形区域、3D图形等)、图形用户界面、根据本公开所采用的一个或多个处理程序或例程的结果(例如,电信号、电异质性信息等)或用于执行本文所述的一个和/或多个过程或方法的任何其它数据。
在一个或多个实施例中,说明性系统、方法和接口可以使用在可编程计算机(例如,包含例如处理能力、数据存储装置(例如,易失性或非易失性存储器和/或存储元件)、输入装置和输出装置的计算机)上执行的一个或多个计算机程序来实施。本文所述的程序代码和/或逻辑可以应用于输入数据以执行本文所述的功能并且生成期望的输出信息。可以将输出信息作为输入应用到本文所描述或将以已知方式应用的一个或多个其它装置和/或方法。
可以使用任何可编程语言来提供用于实施本文所述的系统、方法和/或界面的一个或多个程序,例如适合与计算机系统通信的高级程序和/或面向对象的编程语言。例如,任何此类程序可以存储在可通过在计算机系统(例如,包含处理设备)上运行的用于在合适的设备读取时配置和操作计算机系统以执行本文描述的程序的通用或专用程序读取任何合适的装置上,例如,存储介质。换句话说,至少在一个实施例中,可以使用配置有计算机程序的计算机可读存储介质来实施说明性系统、方法和接口,其中如此配置的存储介质使计算机以具体且预定义的方式进行操作以执行本文所述的功能。进一步地,在至少一个实施例中,可以将说明性系统、方法和/或接口描述为由在一个或多个非暂时性介质中编码的逻辑(例如,目标代码)来实施,所述逻辑包括用于执行的代码,并且在由处理器或处理电路系统执行时,可操作以执行如本文所述的方法、过程和/或功能之类的操作。
计算设备140和远程计算装置160可以是例如任何固定或移动计算机系统(例如,控制器、微控制器、个人计算机、微型计算机、平板计算机等)。计算设备140和远程计算装置160的确切配置不是限制性的,并且可以使用基本上能够提供合适的计算能力和控制能力(例如,信号分析、数学函数如中值、众数、平均值、最大值确定、最小值确定、斜率确定、最小斜率确定、最大斜率确定、图形处理等)的任何装置。如本文所描述的,数字文件可以是含有可以由本文所述的计算设备140和远程计算装置160读取和/或写入的数字位(例如,以二进制、三进制编码)的任何介质(例如,易失性或非易失性存储器、CD-ROM、打孔卡、磁性可记录磁带等)。而且,如本文所描述的,用户可读格式的文件可以是可在可由用户读取和/或理解的任何介质(例如,纸、显示器等)上呈现的数据(例如,ASCII文本、二进制数、十六进制数、十进制数、图形等)的任何表示形式。
鉴于上文,将显而易见的是,可以按照所属领域技术人员已知的任何方式来实施根据本公开的一个或多个实施例中描述的功能。如此,待用于实施本文所述的过程的计算机语言、计算机系统或任何其它软件/硬件不应限于本文所述的系统、过程或程序(例如,由此类系统、过程或程序提供的功能)的范围。进一步地,可以与本公开一起使用的另外的说明性系统、方法和装置可以在于2019年10月9日提交的题为“用于确定心脏状况的系统、方法和装置(Systems,Methods,and Devices for Determining Cardiac Condition)”的美国临时专利申请序列号62/913,002中描述。
说明性电极设备110可以被配置成测量患者14的身体表面电势以及更具体地患者14的躯干表面电势。如图2所示,说明性电极设备110可以包含外部电极112、条带113的集合或阵列和接口/放大器电路系统116。电极112可以附接或耦接到条带113,并且条带113可以被配置成缠绕在患者14的躯干周围,使得电极112围绕患者的心脏。如进一步展示的,电极112可以定位在患者14的周长周围,包含患者14的躯干的后部位置、侧部位置、后外侧位置、前外侧位置和前部位置。
说明性电极设备110可以被进一步被配置成测量或监测来自患者14的至少一个或两个的声音。如图2所示,说明性电极设备110可以包含附接或耦接到条带113的声学传感器120的集合或阵列。条带113可以被配置成缠绕在患者14的躯干周围,使得声学传感器120围绕患者的心脏。如进一步展示的,声学传感器120可以定位在患者14的周长周围,包含患者14的躯干的后部位置、侧部位置、后外侧位置、前外侧位置和前部位置。
进一步地,电极112和声学传感器120可以通过有线连接118电连接到接口/放大器电路系统116。接口/放大器电路系统116可以被配置成放大来自电极112和声学传感器120的信号并将信号提供给计算设备140和远程计算装置160中的一个或两个。其它说明性系统可以使用无线连接(例如,作为数据通道)来将由电极112和声学传感器120感测到的信号传输到接口/放大器电路系统116,并且进而传输到计算设备140和远程计算装置160中的一个或两个。在一个或多个实施例中,可以使用例如模拟电连接、数字电连接、无线连接、基于总线的连接、基于网络的连接、基于因特网的连接等来将接口/放大器电路系统116电耦接到计算设备140。
尽管在图2的实例中,电极设备110包含条带113,但是在其它实例中,可以采用多种机制中的任何机制,例如胶带或粘合剂,来辅助电极112和声学传感器120的间隔和放置。在一些实例中,条带113可以包含松紧带、胶带条或布。进一步地,在一些实例中,条带113可以是一件衣服(例如,T恤)的一部分或与其整合。在其它实例中,电极112和声学传感器120可以单独放置在患者14的躯干上。进一步地,在其它实例中,电极112(例如,布置成阵列)和声学传感器120(例如,也布置成阵列)中的一者或两者可以是贴片、背心和/或将电极112和声学传感器120固定到患者14的躯干的其它方式的一部分或位于其内。仍进一步地,在其它实例中,电极112和声学传感器120中的一者或两者可以是两个材料段或两个贴片的一部分或位于其内。这两个贴片中的一个可以位于患者14的躯干的前侧上(以便例如监测表示患者的心脏的前侧的电信号、测量表示患者的心脏的前侧的替代心脏电激活时间、监测或测量患者的前侧的声音等),并且另一个贴片可以位于患者14的躯干的后侧上(以便例如监测表示患者的心脏的后侧的电信号、测量表示患者的心脏的后侧的替代心脏电激活时间、监测或测量患者的后侧的声音等)。并且仍进一步地,在其它实例中,电极112和声学传感器120中的一者或两者可以布置在从患者14的前侧穿过患者14的左侧延伸到患者14的后侧的顶排和底排中。又仍进一步地,在其它实例中,电极112和声学传感器120中的一者或两者可以布置成围绕腋窝区的曲线并且在右胸上的电极/传感器密度可以低于其它剩余区域的密度。
电极112可以被配置成围绕患者14的心脏并且在信号已经传播穿过患者14的躯干之后记录或监测与心脏的去极化和复极化相关联的电信号。电极112中的每个电极可以以单极配置使用,以感测反映心脏信号的躯干表面电势。接口/放大器电路系统116也可以耦接到可以与用于单极感测的每个电极112组合使用的返回电极或无关电极(未示出)。
在一些实例中,在空间上围绕患者的躯干分布的电极112可以有约12个至约50个并且声学传感器120可以有约12个至约50个。其它配置可以具有更多或更少的电极112和更多或更少的声学传感器120。应当理解,电极112和声学传感器120可以不布置或分布在一直围绕或完全围绕患者14延伸的阵列中。相反,电极112和声学传感器120可以布置在仅围绕患者14的一部分或部分地围绕患者延伸的阵列中。例如,电极112和声学传感器120可以分布在患者的前侧、后侧和左侧上,其中在右侧附近(包含患者的右侧的后部区域和前部区域)具有较少或没有电极和声学传感器。
计算设备140可以记录和分析由电极112感测的躯干表面电势信号和由声学传感器120感测的声音信号,所述信号被接口/放大器电路系统116放大/调节。计算设备140可以被配置成分析来自电极112的电信号以提供来自患者的心脏的心电图(ECG)信号、信息或数据,如本文将进一步描述的。计算设备140可以被配置成分析来自电极112的信号,以提供如替代心脏电激活时间等替代心脏电激活数据,所述替代心脏电激活时间例如表示患者心脏的一个或多个区域的实际或局部电激活时间,如将在本文中进一步描述的。激活时间的测量可以通过选择适当的基准点(例如,近场或远场EGM的峰值、最小值、最小斜率、最大斜率、零交叉点、阈值交叉点等)并测量心脏去极化的开始(例如,QRS复合波的开始)与所述适当的基准点(例如,在电活动内)之间的时间来执行。QRS复合波(或峰值Q波)的开始到基准点之间的激活时间可以被称为q-LV时间。在至少一个实施例中,来自所有多个电极的最早QRS开始可以用作每个电极的每个激活时间的起点,并且QRS复合波的开始之后的最大斜率可以用作每个电极的每个激活时间的终点。计算设备140可以被配置成分析来自声学传感器120的电信号以提供来自患者身体和/或植入其中的装置(如左心室辅助装置)的声音信号、信息或数据。
另外,计算设备140和远程计算装置160可以被配置成提供图形用户界面132、172,所述图形用户界面描绘了与电极设备110相关的各种信息以及使用电极设备110收集或感测的数据。例如,图形用户界面132、172可以描绘包含使用电极设备110获得的QRS复合波的ECG和包含使用声学传感器120获得的声波的声音数据以及与其相关的其它信息。说明性系统和方法可以无创地使用利用电极设备110收集的电信息和利用声学传感器120收集的声音信息来评估患者的心脏健康状况并且评估和配置向患者递送的心脏疗法。
进一步地,电极设备110可以进一步包含例如定位在患者14的下躯干周围的参考电极和/或驱动电极,所述参考电极和/或驱动电极可以进一步由系统100使用。例如,电极设备110可以包含三个参考电极,并且可以将来自三个参考电极的信号组合以提供参考信号。进一步地,电极设备110可以使用三个尾端参考电极(例如,代替在威尔逊中央终端(Wilson Central Terminal)中使用的标准参考)来通过对三个尾端定位的参考信号取平均值获得具有较少噪声的“真实”单极信号。
图3展示了包含多个电极112和多个声学传感器120的另一个说明性电极设备110,所述多个电极被配置成围绕患者14的心脏并且在信号已经传播穿过患者14的躯干之后记录或监测与心脏的去极化和复极化相关联的电信号,所述多个声学传感器被配置成围绕患者14的心脏并且在信号已经传播穿过患者14的躯干之后记录或监测与心脏相关联的声音信号。电极设备110可以包含背心114,多个电极112和多个声学传感器120可以附接在所述背心上或者电极112和声学传感器120可以耦接到所述背心。在至少一个实施例中,所述多个电极112或者所述电极的阵列可以用于收集电信息,例如,替代心脏电激活时间。类似于图2的电极设备110,图3的电极设备110可以包含接口/放大器电路系统116,所述接口/放大器电路系统通过有线连接118电耦接到电极112和声学传感器120中的每一个并且被配置成将信号从电极112和声学传感器120发射到计算设备140。如所展示的,电极112和声学传感器120可以分布在患者14的躯干上,包含例如患者14的躯干的后部位置、侧部位置、后外侧位置、前外侧位置和前部位置。
背心114可以由织物形成,其中电极112和声学传感器120附接到织物。背心114可以被配置成维持电极112和声学传感器120在患者14的躯干上的定位和间隔。进一步地,背心114可以被标记成辅助确定电极112和声学传感器120在患者14的躯干的表面上的位置。在一些实例中,围绕患者14的躯干可以分布有约25到约256个电极112和约25到约256个声学传感器120,尽管其它配置可以具有更多或更少的电极112和更多或更少的声学传感器120。
说明性系统和方法可以用于在患者的心脏健康状况的评估和/或当前(例如,通过递送起搏疗法的植入式医疗装置、通过LVAD等)被递送至患者的心脏治疗的评估和配置中向用户提供无创协助。进一步地,应当理解,计算设备140和远程计算装置160可以以多种不同的方式操作性地彼此耦接以便进行或执行本文所述的功能。例如,在所描绘的实施例中,计算装置140可以可操作地无线耦接到远程计算装置160,如其间发出的无线信号线所描绘的。另外,与无线连接相反,计算设备140和远程计算装置160中的一者或多者可以通过一个或有线电连接可操作地耦接。
本文所述的说明性系统和方法可以为用户(例如,临床医生、医生等)提供有用的工具来确定患者是否将受益于心脏传导系统起搏疗法和/或另一种心脏疗法。进一步地,本文所述的说明性系统和方法可以为用户提供有用的工具来确定心脏传导系统阻滞在患者的心脏传导网络内定位或相对定位的位置。例如,说明性系统和方法可以确定心脏传导系统阻滞被定位成沿患者的心脏传导网络有多近或多远。心脏传导系统阻滞的位置可以有助于确定心脏传导系统起搏疗法和/或另一种心脏疗法是否可以成功地治疗患者。
图4A-4B中描绘了患者的心脏传导网络200。如所示出的,心脏传导网络200从近侧区域222延伸到远侧区域224。心脏传导网络200包含包括左束支和右束支的专门细胞网络以及高度分支的专门浦肯野纤维网络,所述专门浦肯野纤维网络有助于电激活跨心室的快速传播,这可能会导致心脏的激活非常同步。心脏传导系统是通过房室结232从窦房结230延伸到心室的自然电传导通路的一部分。进一步地,触发患者心脏的心肌组织的去极化以有效地“跳动”的电脉冲从窦房结230穿过心脏传导网络200到达浦肯野纤维239。
如本文所描述的,心脏传导网络200的近侧区域222可以包含窦房结230和房室结232以及它们之间的联运通路,并且心脏传导网络200的远侧区域224可以包含右束支238、左后束236和浦肯野纤维239。具体地,心脏传导网络200的最远侧区域可以是浦肯野纤维239的末端,并且心脏传导网络200的最近侧区域可以是窦房结230。因此,心脏传导网络200可以被描述为从窦房结230延伸到浦肯野纤维239。
在图4A中,心脏传导系统阻滞240正好定位在房室结232的远侧,但是在分支到左束和右束的希氏束234之前。因此,可以描述心脏传导系统阻滞240沿心脏传导网络220相对靠近地定位。使用如本文进一步描述的说明性系统和方法,可以确定一个或多个电异质性左度量,其指示当心脏传导系统阻滞240如图4A所示定位时左心室中的大范围242延迟。因此,心脏传导系统阻滞240可以是心脏传导系统起搏疗法的良好候选者,因为例如心脏传导系统起搏疗法可以被递送到心脏传导系统阻滞240远侧的心脏传导系统内的定位或位置。例如,可以将心脏传导系统起搏疗法递送到希氏束234和/或右分支和左分支两者中的一者。
在图4B中,心脏传导系统阻滞241沿正好在左后分支远侧的左分支定位。因此,可以描述心脏传导系统阻滞241沿心脏传导网络220相对远侧地定位。使用如本文进一步描述的说明性系统和方法,可以确定一个或多个电异质性左度量,其指示当心脏传导系统阻滞241如图4B所示定位时左心室中的大范围243延迟。因此,心脏传导系统阻滞241可能不是心脏传导系统起搏疗法的良好候选者,因为例如心脏传导系统起搏疗法可能无法被定位成比心脏传导系统阻滞241更远,并且如果心脏传导系统起搏疗法定位在心脏传导系统阻滞241的近侧(例如,在希氏束234处),则任何这样的心脏传导系统起搏疗法都可以被心脏传导系统阻滞241阻止或停止。因此,当比较图4A-4B的心脏传导系统阻滞240、241时,使用心脏传导系统起搏疗法,更近侧的心脏传导系统阻滞240可能比图4B的更远侧的心脏传导系统阻滞241更加可纠正。
图5A中描绘了用于确定心脏传导系统起搏疗法是否有益的说明性方法400。如所示出的,方法400包含监测410电活动以产生多个电信号(例如,ECG或心脏信号)。可以在患者的固有心律期间监测电活动,而无需递送任何心脏疗法。因此,方法400可以在植入任何植入式心脏疗法装置之前执行。例如,方法400可以在用于治疗当前病状的任何有创手术之前的初始咨询期间执行。另外,如本文所描述的,使用多个外部电极来监测电活动410是无创过程,因为例如与插入或植入任何电极以获取电活动或数据相反,外部电极附接到患者的皮肤。然而,另外,如果植入式心脏疗法装置已经植入患者体内,则方法400可以在禁用(或“关闭”)由植入式心脏疗法装置提供的任何心脏疗法的情况下执行。
根据各种实施例,使用多个电极来监测410电活动。所述多个电极可以是类似于本文关于图1-3所述的绑带或背心中配置的外表面电极。所述电极中的每个电极可以围绕患者的躯干定位或设置,以便从患者的躯干周围的多个不同位置监测电活动(例如,获取躯干电势)。电极所在的不同位置中的每个位置可以对应于患者心脏的不同心脏组织部分或区域的电激活。因此,例如,在信号已经传播穿过患者的躯干之后,多个电极可以记录或监测与心脏的或心脏附近的多个不同位置的去极化和复极化相关联的电信号。根据各种实施例,多个外部电极可以包含或包括靠近患者躯干前部的皮肤定位的多个前部电极、靠近患者躯干左侧位或左侧的皮肤定位的左侧位或左侧电极,以及靠近患者躯干后部的皮肤定位的后部电极。
可以描述的是,当使用多个外部电极时,监测过程410可以提供多个心电图(ECG)、表示患者心脏的去极化和复极化的信号。所述多个ECG进而可以用于生成表示心脏的去极化的替代心脏电激活时间415。如本文所描述的,替代心脏电激活时间可以例如表示患者心脏的一个或多个区域的实际或局部电激活时间。激活时间的测量可以通过选择适当的基准点(例如,近场或远场EGM的峰值、最小值、最小斜率、最大斜率、零交叉点、阈值交叉点等)并测量心脏去极化的开始(例如,QRS复合波的开始)与所述适当的基准点(例如,在电活动内)之间的时间来执行。QRS复合波(或峰值Q波)的开始到基准点之间的激活时间可以被称为q-LV时间。在至少一个实施例中,来自所有多个电极的最早QRS开始可以用作每个电极的每个激活时间的起点,并且QRS复合波的开始之后的最大斜率可以用作每个电极的每个激活时间的终点。
监测到的电活动410以及电激活时间415可以用于生成电异质性信息(EHI)420。所述EHI(例如,数据)可以被定义为指示心脏的机械同步或不同步和/或心脏的电同步或不同步中的至少一种的信息。换句话说,EHI可以表示患者的心脏的实际机械和/或电功能的替代。在至少一个实施例中,EHI(例如,从基线异质性信息到疗法异质性信息、从第一组异质性信息到第二组疗法异质性信息等)的相对变化可以用于确定表示血流动力学应答变化的替代值(例如,LV压力梯度的急剧变化)。左心室压力通常可以用定位在患者的心脏的左心室中的压力传感器有创地监测。如此,使用EHI来确定表示左心室压力的替代值可以避免使用左心室压力传感器的有创监测。
在至少一个实施例中,EHI可以包含使用例如本文关于图1-3所描述的电极设备110的外部电极中的一些或所有外部电极测量的心室激活时间的标准偏差。进一步地,局部或区域EHI可以包含使用定位在躯干的某些解剖区域中的电极测量的激活时间的标准偏差和/或平均值。例如,患者的躯干的左侧上的外部电极可以用于计算局部或区域左侧EHI。
可以使用一种或多种不同的系统和/或方法来生成EHI。例如,EHI可以使用表面电极和/或成像系统阵列或多个表面电极和/或成像系统来生成,如以下文献中所描述的:于2016年12月6日发布的并且题为“评估心脏内激活模式和电不同步(ASSESSING INRA-CARDIAC ACTIVATION PATTERNS AND ELECTRICAL DYSSYNCHRONY)”的美国专利第9,510,763B2号、于2015年3月3日发布的并且题为“评估心脏内激活模式(ASSESSING INTRA-CARDIAC ACTIVATION PATTERNS)”的美国专利第8,972,228B2号,以及于2012年5月15日发布的并且题为“用于选择心脏起搏部位的方法和系统(METHODS AND SYSTEMS FOR USE INSELECTING CARDIAC PACING SITES)”的美国专利第8,180,428B2号。
EHI可以包含一个或多个度量或指标。例如,电异质性的度量或指标之一可以是使用患者的躯干表面上的一些或所有电极测量的激活时间的标准偏差(SDAT)。在一些实例中,可以使用模型心脏的表面上的替代或估计的心脏激活时间来计算SDAT。
在此实例中,EHI包括基于使用多个左外部电极测量的替代心脏电激活时间的左侧激活时间生成的一个或多个左度量或左侧度量。左外部电极可以包含定位于患者躯干左侧的多个左外部电极。
电异质性或不同步性的一个左度量或左侧度量或指标可以是由靠近患者的左侧定位的外部电极监测的替代心脏电激活时间(LVED)的左标准偏差。进一步地,电异质性的另一个左度量或左侧度量或指标可以包含由靠近患者的左侧定位的外部电极监测的替代心脏电激活时间(LVAT)的平均值。LVED和LVAT可以根据仅由患者的左侧附近的电极测量的电活动来确定(例如,计算、估算等),这些电极可以被称为“左”电极。从左电极确定或测量的激活时间可以被描述为左侧激活时间。左电极可以被定义为靠近左心室定位的包含患者的胸骨和脊柱左侧的身体或躯干区域(例如,朝向患者的左臂、患者的左侧等等)的任何表面电极。在一个实施例中,左电极可以包含胸骨的左侧的所有前电极和脊柱的左侧的所有后电极。在另一个实施例中,左电极可以包含胸骨左侧的所有前电极和所有后电极。在又另一个实施例中,可以基于如使用成像设备(例如,X射线、荧光透视等)确定的心脏的左侧和右侧的轮廓来指定左电极。
电异质性或不同步性的另一个说明性左度量或左侧度量或指标可以包含左侧替代心脏电激活时间的左侧晚期激活百分比。在一个或多个实施例中,左侧替代心脏电激活时间的左侧晚期激活百分比可以利用左侧晚期激活阈值来确定。例如,产生大于或等于左侧晚期激活阈值的替代心脏电激活时间的左电极的百分比可以是左侧晚期激活百分比。在至少一个实施例中,左侧晚期激活阈值为50毫秒(ms)。左侧晚期激活阈值可以介于约35ms与约85ms之间。在一个或多个实施例中,左侧晚期激活阈值大于或等于35ms、大于或等于45ms、大于或等于55ms、大于或等于65ms等,和/或小于或等于85ms、小于或等于75ms、小于或等于60ms、小于或等于50ms等。
因此,在左侧晚期激活阈值为40ms的实例中,如果32个左电极中的22个左电极具有大于或等于40ms的替代心脏电激活时间,则左侧晚期激活百分比为69%。进一步地,在左侧晚期激活阈值为45ms的实例中,如果32个左电极中的4个左电极具有大于或等于45ms的替代心脏电激活时间,则左侧晚期激活百分比为13%。左侧晚期激活百分比大可能意味着患者心脏的左区域(例如,左心室)的相当一部分的激活延迟。
然后,说明性方法400可以基于生成的EHI,并且具体地是左或左侧EHI,确定心脏传导系统起搏疗法是否将有益于患者430。例如,可以分析左侧晚期激活百分比和LVAT中的一者或两者以确定心脏传导系统起搏疗法是否有益于患者430。另外,应当理解,确定心脏传导系统起搏疗法是否有益于患者430可能不一定是二元的或是与否的确定,而是替代地可能是患者的心脏传导系统心脏起搏疗法成功的可能性。例如,心脏传导系统起搏疗法成功的可能性可以用百分比或通过例如“心脏传导系统起搏疗法很可能是有益的”、“心脏传导系统起搏疗法可能是有益的”、“心脏传导系统起搏疗法不太可能是有益的”和“心脏传导系统起搏疗法极不可能是有益的”等描述符来表达或表示。
另外,例如,可以在图形用户界面上显示基于所生成的EHI(如左EHI)的对心脏传导系统起搏疗法是否将有益于患者的指示。更具体地,例如,在包含多个外部电极的电极设备已经被应用于患者之后,用户(例如,临床医生、医生等)可以使用显示器的图形用户界面通过例如选择图形用户界面上的按钮或其它区域来启动心脏传导系统益处确定。因此,响应于用户启动心脏传导系统起搏疗法益处确定,说明性系统和方法可以监测电活动410,测量替代心脏电激活时间415,生成EHI 420,基于所生成的EHI确定心脏传导系统起搏疗法是否将有益于患者430,并且然后在图形用户界面上显示心脏传导系统起搏疗法是否将有益于患者的指示。
图5B中示出了确定心脏传导系统起搏疗法是否将有益于方法400的患者的说明性方法430。说明性方法430可以利用左侧晚期激活百分比和LVAT中的一者或两者来确定心脏传导系统起搏疗法是否有益于患者430。
可以将左侧晚期激活百分比与此实例中示出的40%的左侧晚期激活百分比阈值432进行比较。因此,如果左侧晚期激活百分比大于或等于40%,则确定心脏传导系统阻滞更靠近心脏传导网络的近侧区域设置或定位436,并且进而确定心脏传导系统起搏疗法是有益的438。相反,如果左侧晚期激活百分比小于40%,则确定心脏传导系统阻滞更靠近心脏传导网络的远侧区域设置或定位440,并且进而确定心脏传导系统起搏疗法不太可能是有益的442。
左侧晚期激活百分比阈值可以介于约30%与约80%之间。在一个或多个实施例中,左侧晚期激活百分比阈值大于或等于30%、大于或等于40%、大于或等于60%、大于或等于70%等,和/或小于或等于80%、小于或等于65%、小于或等于50%等。
可以将LVAT与此实例中所示的50ms的LVAT阈值434进行比较。因此,如果LVAT大于或等于50ms,则确定心脏传导系统阻滞更靠近心脏传导网络的近侧区域设置或定位436,并且进而确定心脏传导系统起搏疗法是有益的438。相反,如果LVAT小于50ms,则确定心脏传导系统阻滞更靠近心脏传导网络的远侧区域设置或定位440,并且进而确定心脏传导系统起搏疗法不太可能是有益的442。
LVAT阈值可以介于约35ms与约85ms之间。在一个或多个实施例中,左侧晚期激活阈值大于或等于35ms、大于或等于45ms、大于或等于55ms、大于或等于65ms等,和/或小于或等于85ms、小于或等于75ms、小于或等于60ms、小于或等于50ms等。
可选地,左侧晚期激活百分比和LVAT确定过程432、434中的每一个可以结合使用,以确定心脏传导系统起搏疗法是否将有益于患者430。例如,在此实施例中,左侧晚期激活百分比必须大于或等于左侧晚期激活百分比阈值432并且LVAT必须大于或等于LVAT阈值434,以用于确定心脏传导系统阻滞更靠近心脏传导网络的近侧区域设置或定位436,并且进而确定心脏传导系统起搏疗法是有益的438。相反,在此实施例中,如果左侧晚期激活百分比和LVAT中只有一个大于或等于其相应阈值,则确定心脏传导系统阻滞更靠近心脏传导网络的远侧区域设置或定位440,并且进而确定心脏传导系统起搏疗法不太可能是有益的442。
图6A中描绘了后来接受希氏束起搏的患者的三组不同的固有心电数据。更具体地,示出了15名患者的固有或基线LVAT平均值和范围,示出了相同的15名患者的固有或基线SDAT平均值和范围,并且示出了相同的15名患者的固有或基线QRS持续时间平均值和范围。如所示出的,使用心脏传导系统起搏疗法——具体地是希氏束起搏疗法,15名患者中有6名患者的左束支阻滞得到成功治疗。可以看出,55ms的LVAT阈值将正确识别使用希氏束起搏疗法成功治疗的6名患者中的6名患者(即,100%灵敏度),并且将识别使用希氏束起搏疗法未成功治疗的9名患者中的8名(即,89%特异性)。如所示出的,LVAT的p值为0.04。相比之下,对于用希氏束起搏成功纠正的患者与没有纠正的患者,无论是全局度量、SDAT或QRS持续时间都没有明显差别,p值分别为0.15和0.69。
图6B中描绘了经受左束支阻滞的两名患者(受试者A和受试者B)的固有或基线激活以及希氏束起搏期间的前部和后部激活图。如所示出的,受试者A和B两者在固有激活期间具有类似的SDAT——分别为41.2ms和37.3ms——但在固有激活期间具有明显不同的LVAT——分别为63.3ms和46.6ms。
说明性系统和方法可以确定受试者A将受益于传导系统起搏疗法,因为例如受试者A的固有LVAT超过50ms的LVAT阈值。相反,说明性系统和方法可能无法确定受试者B将受益于传导系统起搏疗法,因为例如受试者B的固有LVAT小于50ms的LVAT阈值。
向受试者A和B两者递送希氏束起搏疗法的结果表明,说明性系统和方法是正确的,因为希氏束起搏疗法似乎仅有益于受试者A。更具体地,在希氏束起搏期间,受试者A的SDAT下降了近50%并且LVAT下降了37%。相比之下,受试者B的SDAT略微下降了约15%,而LVAT实际上增加了18%。在一个或多个实施例中,用于确定左束支阻滞是否已被纠正的阈值是LVAT从固有或基线水平降低大于20%。
如本文所描述的,说明性系统和方法可以帮助用户(例如,临床医生、医生等)确定患者是否可以受益于心脏传导系统起搏疗法和/或确定心脏传导系统阻滞在心脏传导网络内或沿心脏传导网络的位置。在一个或多个实施例中,说明性心脏传导系统起搏疗法可以利用旨在对患者的心脏传导系统的一个或多个区或区域进行起搏或向其递送电起搏的任何植入式或非植入式心脏起搏系统。心脏传导系统起搏疗法可以使用定义单个起搏向量的单个起搏电极或定义多个起搏向量的多个起搏电极。
心脏传导系统起搏疗法的一个实例可以是本文关于图7-10描述和示出的心房至心室(VfA)起搏疗法。VfA起搏疗法可以被配置成将电起搏递送到心脏传导系统的一个或多个区,包含但不限于左束支和右束支的区。
心脏传导系统起搏疗法的另一个实例可以是希氏束起搏疗法,例如以下文献中所描述的:于2018年10月17日提交的题为“希氏束和束支起搏调整(His Bundle and BundleBranch Pacing Adjustment)”的美国专利申请序列号16/163,132,所述美国专利申请通过引用整体并入本文。心脏传导系统起搏疗法的仍另一个实例可以是间隔内左心室心内膜起搏疗法,例如以下文献中所描述的:于2007年2月13日发布的题为“起搏方法和设备(PacingMethod and Apparatus)”的美国专利第7,177,704号。
图7中描绘了说明性心房至心室(VfA)心脏疗法系统,所述系统可以被配置成与例如本文关于图1-6所描述的系统和方法一起使用。尽管应当理解,本公开可以利用无引线和有引线植入式医疗装置中的一者或两者,但是图7的说明性心脏疗法系统包含无引线心内医疗装置10,所述无引线心内医疗装置可以被配置成用于单腔或双腔疗法并植入在患者的心脏8中。在一些实施例中,装置10可以被配置成用于单腔起搏,并且可以例如在单腔起搏与多腔起搏(例如,双腔或三腔起搏)之间进行切换。如本文所用,“心内”是指被配置成完全植入在患者的心脏内,例如,以提供心脏疗法的装置。示出了植入在患者的心脏8的右心房(RA)的目标植入区域4中的装置10。装置10可以包含将装置10的远端锚定在目标植入区域4中的心房心内膜上的一个或多个固定构件20。目标植入区域4可以位于希氏束5与冠状窦3之间,并且可以邻近或紧邻三尖瓣6。装置10可以被描述为心房至心室装置,因为装置10可以在通常安置在右心房中的同时可以进行或执行两者之一:感测来自一个或两个心室(例如,右心室、左心室或两个心室,视情况而定)的电活动并向其提供疗法。具体地,装置10可以包含组织刺穿电极,所述组织刺穿电极可以从右心房的科赫三角(triangle of Koch)区域通过右心房心内膜和中心纤维体植入在患者的心脏的左心室心肌的基底和/或间隔区域中。
装置10可以被描述为无引线植入式医疗装置。如本文所用,“无引线”是指没有从患者的心脏8延伸出来的引线的装置。进一步地,尽管无引线装置可以具有引线,但引线不会从患者的心脏外部延伸到患者的心脏内部或者不会从患者的心脏内部延伸到患者的心脏外部。一些无引线装置可以穿过静脉引入,但是一旦被植入,所述装置就没有或可以不包含任何经静脉引线,并且可以被配置成在不使用任何经静脉引线的情况下提供心脏疗法。进一步地,当装置的壳体定位于心房中时,具体地,无引线VfA装置不使用引线来可操作地连接到心室中的电极。另外,无引线电极可以耦接到医疗装置的壳体,而无需在电极与壳体之间使用引线。
装置10可以包含镖电极组合件12,所述镖电极组合件限定或具有从装置10的远端区域延伸的笔直轴。镖电极组合件12可以放置或者至少被配置成放置为穿过心房肌和中心纤维体并且进入到心室肌14中或沿着心室间隔,而不完全穿透心室心内膜或心外膜表面。镖电极组合件12可以携带或包含轴的远端区域处的电极,使得所述电极可以定位在心室心肌内,以用于感测心室信号并递送心室起搏脉冲(例如,使左心室和/或右心室去极化以引起左心室和/或右心室的收缩)。在一些实例中,在轴的远端区域处的电极是被提供以在用于起搏和感测的双极电极对中使用的阴极电极。虽然如所展示的植入区域4可以使得镖电极组合件12的一个或多个电极能够定位于心室心肌中,但是应认识到,具有本文所公开的各方面的装置可以在适当时被植入在其它位置以进行多腔起搏(例如,双腔或三腔起搏)、伴有多腔感测的单腔起搏、单腔起搏和/或感测,或其它临床疗法和应用。
应理解,尽管本文将装置10描述为包含单个镖电极组合件,但是装置10可以包含多于一个镖电极组合件,所述多于一个镖电极组合件放置或被配置成放置为通过心房心肌和中央纤维体并且到心室心肌14中或沿着心室间隔,而不完全通过心室心内膜或心外膜表面。另外,每个镖电极组合件可以在轴的远端区域处或沿轴的其它区域(例如,近侧区域或中心区域)携带或包含多于单个电极。
心脏疗法系统2还可以包含单独的医疗装置50(在图7中示意性地描绘),所述单独的医疗装置可以定位在患者的心脏8的外部(例如,皮下)并且可以可操作地耦接到患者的心脏8以向其递送心脏疗法。在一个实例中,单独的医疗装置50可以是血管外ICD。在一些实施例中,血管外ICD可以包含除颤引线,所述除颤引线包括或携带除颤电极。在除颤引线上的除颤电极与ICD的壳体电极之间可以存在疗法载体。进一步地,ICD的一个或多个电极也可以用于感测与患者的心脏8有关的电信号。ICD可以被配置成递送包含一种或多种除颤或心脏复律电击的电击疗法。例如,如果感测到心律失常,则ICD可以通过电引线发送脉冲,以电击心脏并且恢复其正常节律。在一些实例中,ICD可以递送电击疗法而无需将电引线放置在心脏内或将电线直接附接到心脏(皮下ICD)。可以与本文中所描述的系统2一起使用的血管外皮下ICD的实例可以在2016年3月8日发布的美国专利第9,278,229号(Reinke等人)中进行描述,所述美国专利以全文引用的方式并入本文中。
在电击疗法(例如,由除颤引线的除颤电极提供的除颤电击)的情况下,单独的医疗装置50(例如,血管外ICD)可以包含控制电路,所述控制电路使用疗法递送电路来生成具有多种波形特性(包含前沿电压、倾斜度、所递送的能量、脉冲相位等)中的任何波形特性的除颤电击。疗法递送电路可以例如生成单相、双相或多相波形。另外,疗法递送电路可以生成具有不同量的能量的除颤波形。例如,疗法递送电路可以生成为皮下除颤递送总共大约60-80焦耳(J)之间的能量的除颤波形。
单独的医疗装置50可以进一步包含感测电路。感测电路可以被配置成获得通过电极的一种或多种组合感测的电信号,并且处理所获得的信号。感测电路的组件可以包含模拟组件、数字组件或其组合。感测电路可以例如包含一个或多个读出放大器、滤波器、整流器、阈值检测器、模数转换器(ADC)等。感测电路可以将感测到的信号转换为数字形式,并且将数字信号提供给控制电路以进行处理和/或分析。例如,感测电路可以放大来自感测电极的信号,并且通过ADC将放大的信号转换为多位数字信号,并且然后将数字信号提供给控制电路。在一个或多个实施例中,感测电路还可以将经过处理的信号与阈值进行比较,以检测心房或心室去极化(例如,P波或R波)的存在并且向控制电路指示心房去极化(例如,P波)或心室去极化(例如,R波)的存在。
装置10和单独的医疗装置50可以协作以向患者的心脏8提供心脏疗法。例如,装置10和单独的医疗装置50可以用于检测心动过速、监测心动过速和/或提供心动过速相关疗法。例如,装置10可以与单独的医疗装置50进行无线通信,以使用单独的医疗装置50来触发电击疗法。如本文所用,“无线”是指在装置10与单独的医疗装置50之间不使用金属导体的操作性耦接或连接。在一个实例中,无线通信可以使用由装置10提供的传导通过患者的组织并且可由单独的医疗装置50检测到的独特、信令或触发电脉冲。在另一个实例中,无线通信可以使用装置10的通信接口(例如,天线)来提供电磁辐射,所述电磁辐射传播穿过患者的组织并且可例如使用单独的医疗装置50的通信接口(例如,天线)检测到。
图8是图7的心内医疗装置10和患者心脏的解剖结构8的放大概念图。具体地,装置10被配置成感测心脏信号和/或递送起搏疗法。心内装置10可以包含壳体30。壳体30可以限定装置10的内部组件(如结合图10总体上所描述的感测电路、疗法递送电路、控制电路、存储器、遥测电路、其它任选的传感器以及电源)所驻留的气密密封内部空腔。壳体30可以包含(例如,由其形成或从其形成)例如钛或钛合金、不锈钢、MP35N(非磁性镍钴铬钼合金)、铂合金或其它生物兼容性金属或金属合金等导电材料。在其它实例中,壳体30可以包含非导电材料(例如,由其形成或从其形成),所述非导电材料包括陶瓷、玻璃、蓝宝石、硅酮、聚氨基甲酸酯、环氧树脂、乙酰基共聚物塑料、聚醚醚酮(PEEK)、液晶聚合物或其它生物兼容性聚合物。
在至少一个实施例中,壳体30可以被描述为在远端区域32与近端区域34之间延伸并且被描述为限定总体上圆柱形的形状,例如以促进导管递送。在其它实施例中,壳体30可以是棱柱形或任何其它形状以执行本文所述的功能和效用。壳体30可以包含例如限定或定位在近端区域34处的用于在装置10的植入期间与递送工具接合的递送工具接口构件26。
壳体30的全部或一部分可以在心脏疗法期间充当感测和/或起搏电极。在所示的实例中,壳体30包括近侧基于壳体的电极24,所述电极外接壳体30的近侧部分(例如,与远端区域32相比,更靠近近端区域34)。当壳体30(例如,限定导电材料(如钛合金或上文所列的其它实例)、由其形成等时,可以通过非导电材料(如聚对二甲苯、聚氨基甲酸酯、硅酮、环氧树脂或其它生物兼容性聚合物的涂层)对壳体30的部分进行电绝缘,从而使导电材料的一个或多个离散区暴露出来以形成或限定近侧基于壳体的电极24。当壳体30(例如,限定例如陶瓷、玻璃或聚合物材料等非导电材料或由其形成等)时,可以将例如钛、铂、不锈钢或其合金之类的导电涂层或层施加到壳体30的一个或多个离散区,以形成或限定近侧基于壳体的电极24。在其它实例中,近侧基于壳体的电极24可以是安装或组装到壳体30上的组件,如环形电极。近侧基于壳体的电极24可以例如通过导电壳体30或当壳体30是非导电材料时通过电导体电耦接到装置10的内部电路系统。
在所示出的实例中,近侧基于壳体的电极24被定位成与壳体远端区域32相比,更靠近壳体近端区域34,并且因此可以被称为近侧基于壳体的电极24。然而,在其它实例中,近侧基于壳体的电极24可以定位于沿壳体30的其它定位处,例如,相对于所示位置更远。
在远端区域32处,装置10可以包含远侧固定和电极组合件36,所述远侧固定和电极组合件可以包含一个或多个固定构件20和长度相等或不相等的一个或多个镖电极组合件12。在如所示出的一个此类实例中,单个镖电极组合件12包括向远侧延伸远离壳体远端区域32的轴40,以及在轴40的自由远端区域处或附近的一个或多个电极元件,如尖端电极42。尖端电极42可以具有圆锥形或半球形的远侧尖端,所述远侧尖端具有相对较窄的尖端直径(例如,小于约1毫米(mm)),其用于穿入并且穿过组织层,而无需使用具有尖锐或斜面边缘的尖锐尖端或针状尖端。
镖电极组合件12可以被配置成刺穿一个或多个组织层,以将尖端电极42定位于期望的组织层(例如,心室心肌)内。如此,轴40的高度47或长度可以对应于预期的起搏部位深度,并且轴40可以沿其纵向轴线具有相对较高的抗压强度,以在被压向并进入到植入区域4时抵抗在侧向或径向方向上弯曲。如果采用第二镖电极组合件12,则其长度可以不等于预期的起搏部位深度,并且可以被配置成充当用于将起搏能量递送到组织和/或从所述组织感测信号的无关电极。在一个实施例中,可以例如通过向壳体30的近端区域34施加纵向推力而对尖端电极42施加纵向轴向力,以将镖电极组合件12推进到目标植入区域内的组织中。
轴40可以被描述为当经受横向或径向力时,在横向或径向方向上是纵向上非压缩的和/或可弹性变形的,以允许例如随着组织运动而暂时弯曲,但是当横向力减小时可返回到其正常笔直定位。因此,包含轴40的镖电极组合件12可以被描述为是弹性的。当轴40没有暴露于任何外力或仅暴露于沿其纵向中心轴线的力时,轴40可以保持如图所示的笔直的线性定位。
换句话说,镖电极组合件12的轴40正常可以为笔直的构件并且可以为刚性的。在其它实施例中,轴40可以被描述为是相对坚硬的,但是在侧向方向上仍具有有限的柔性。进一步地,轴40可以是非刚性的,以允许随着心脏运动而发生一些侧向弯曲。然而,在松弛状态下,当未经受到任何外力时,轴40可以维持如图所示的笔直定位,以将尖端电极42与壳体远端区域32间隔开至少轴40的高度或长度47。
所述一个或多个固定构件20可以被描述为具有正常弯曲定位的一个或多个“尖齿”。尖齿可以被保持在递送工具内的向远侧延伸的定位中。在从递送工具释放时向近侧弹性地或有弹性地弯曲回到正常弯曲定位(如图所示)之前,尖齿的远侧尖端可以穿透心脏组织到有限的深度。进一步地,固定构件20可以包含例如发布于2017年6月13日的美国专利第9,675,579号(Grubac等人)和发布于2015年9月1日的美国专利第9,119,959号(Rys等人)中描述的一个或多个方面。
在一些实例中,远侧固定和电极组合件36包含远侧基于壳体的电极22。在使用装置10作为起搏器进行多腔起搏(例如,双腔或三腔起搏)和感测的情况下,尖端电极42可以用作与充当返回阳极电极的近侧基于壳体的电极24配对的阴极电极。可替代地,远侧基于壳体的电极22可以充当与用于感测心室信号并且递送心室起搏脉冲的尖端电极42配对的返回阳极电极。在其它实例中,远侧基于壳体的电极22可以是用于感测心房信号并且将起搏脉冲递送到目标植入区域4中的心房心肌的阴极电极。当远侧基于壳体的电极22充当心房阴极电极时,近侧基于壳体的电极24可以充当与用于心室起搏和感测的尖端电极42配对的返回阳极,并且可以充当与用于心房起搏和感测的远侧基于壳体的电极22配对的返回阳极。
如此图示中所示出的,在一些起搏应用中,目标植入区域4沿心房心内膜18,通常在AV结15和希氏束5下面。镖电极组合件12可以至少部分地限定轴40的高度47或长度,以穿过目标植入区域4中的心房心内膜18,穿过中央纤维体16,并且进入到心室肌14中而不穿透心室心内膜表面17。当镖电极组合件12的高度47或长度被完全推进到目标植入区域4中时,尖端电极42可以置于心室肌14内,并且远侧基于壳体的电极22可以被定位成紧密接触或极为接近心房心内膜18。在各个实例中,镖电极组合件12可以具有尖端电极42与轴40的总组合高度47或长度,为约3mm至约8mm。轴40的直径可以小于约2mm,并且可以为约1mm或更小,或甚至约0.6mm或更小。
图9是患者的心脏的二维(2D)心室图300(例如,自上而下的视图),其示出了呈标准17段视图的左心室320以及右心室322。图300限定或包含对应于人体心脏的不同区域的多个区326。如所展示的,将区326数字标记为1至17(例如,其对应于标准的17段人心脏模型,对应于人体心脏的左心室的17段)。图300的区326可以包含基底前区1、基底前间隔区2、基底下间隔区3、基底下区4、基底下侧区5、基底前侧区6、中前区7、中前间隔区8、中下间隔区9、中下区10、中下侧区11、中前侧区12、顶前区13、顶间隔区14、顶下区15、顶侧区16和顶点区17。还示出了右心室322的下间隔和前间隔区,以及右束支(RBB)25和左束支(LBB)27。
在一些实施例中,本公开的任何组织刺穿电极可以被植入在患者心脏的左心室心肌的基底和/或间隔区域中。具体地,组织刺穿电极可以从右心房的科赫三角区域穿过右心房心内膜和中心纤维体而植入。一旦被植入,组织刺穿电极就可以定位在目标植入区域4(图7-8)中,如左心室心肌的基底和/或间隔区域。参考图300,基底区域包含基底前区1、基底前间隔区2、基底下间隔区3、基底下区4、中前区7、中前间隔区8、中下间隔区9和中下区10中的一个或多个。参考图300,间隔区域包含基底前间隔区2、基底前间隔区3、中前间隔区8、中下间隔区9和顶间隔区14中的一个或多个。
在一些实施例中,当植入时,组织刺穿电极可以定位于左心室心肌的基底-间隔区域中。基底间隔区可以包含基底前间隔区2、基底下间隔区3、中前间隔区8和中下间隔区9中的一个或多个。
在一些实施例中,当植入时,组织刺穿电极可以定位于左心室肌的高下/后基底间隔区域中。左心室心肌的高下/后基底间隔区域可以包含基底下间隔区3和中下间隔区9中的一个或多个区(例如,仅基底下间隔区、仅中下间隔区或基底下间隔区和中下间隔区两者)的一部分。例如,高下/后基底间隔区域可以包含总体上图示为虚线边界的区域324。如所示出的,虚线边界表示高下/后基底间隔区域大约所在的位置,取决于特定应用,其形状或大小可能略有不同。
图10中描绘了根据一个实例的可以被围封在装置10的壳体30内或本文所描述的任何其它医疗装置的壳体内以提供感测心脏信号、确定夺获和/或递送起搏疗法的功能的电路系统的框图。如图7所示的单独的医疗装置50可以包含可以以类似方式进行配置的一些或所有相同组件。围封在壳体30内的电子电路系统可以包含软件、固件和硬件,所述软件、固件和硬件协作地监测心房和心室的心电信号,确定是否发生了心脏系统夺获,确定何时需要心脏疗法和/或根据编程的疗法模式和脉冲控制参数向患者心脏递送电脉冲。电子电路系统可以包含控制电路80(例如,包含处理电路系统)、存储器82、疗法递送电路84、感测电路86和/或遥测电路88。在一些实例中、装置10包含用于产生与患者的一种或多种生理功能、状态或病状相关的信号的一个或多个传感器90。例如,传感器90可以包含患者活动传感器,以用于确定对起搏疗法的需要和/或控制起搏速率。换句话说,装置10可以包含用于感测来自患者的信号的其它传感器90,以用于确定是否递送和/或控制由疗法递送电路84递送的电刺激疗法。
电源98可以按需对包含组件80、82、84、86、88、90中的每一个的装置10的电路系统提供电力。电源98可以包含一个或多个储能装置,如一个或多个可再充电或不可再充电电池。可以从向所属领域的一般技术人员展示的总框图中理解电源98与组件80、82、84、86、88、90中的每一个之间的连接(未示出)。例如,电源98可以耦接到包含在疗法递送电路84中的一个或多个充电电路,以便提供用以对包含在疗法递送电路84中的保持电容器进行充电的电力,所述保持电容器在控制电路80的控制下在适当时候进行放电,以例如根据双腔起搏模式(如DDI(R))来递送起搏脉冲。电源98还可以耦接到感测电路86的组件(如感测放大器、模数转换器、开关电路系统等)、传感器90、遥测电路88和存储器82,以向各种电路提供电力。
图10中所示出的功能块表示装置10中包含的功能,并且可以包含实施模拟和/或数字电路的任何离散和/或集成电子电路组件,所述模拟和/或数字电路能够产生归因于本文所描述的医疗装置10的功能。各个组件可以包含执行一个或多个软件或固件程序的处理电路系统(如专用集成电路(ASIC)、电子电路、处理器(共享、专用或组)和存储器)、组合逻辑电路、状态机或其它提供所描述的功能的合适的组件或组件的组合。将主要由医疗装置中采用的特定系统架构以及由医疗装置采用的特定检测和疗法递送方法来确定用于实施本文所公开的功能的软件、硬件和/或固件的特定形式。
存储器82可以包含任何易失性、非易失性、磁性或电非暂时性计算机可读存储介质,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)、闪速存储器或任何其它存储器装置。此外,存储器82可包含存储指令的非暂时性计算机可读介质,所述指令在由一个或多个处理电路执行时,使控制电路80和/或其它处理电路系统确定左后束支接合和/或执行单腔、双腔或三腔校准的起搏疗法(例如,单腔或多腔起搏)或归因于装置10的其它心脏疗法功能(例如,感测或递送疗法)。存储指令的非暂态计算机可读介质可以包含上文所列的介质中的任一种介质。
控制电路80可以例如通过数据总线与疗法递送电路84和感测电路86通信,以感测心脏电信号并且响应于感测到的心脏事件(例如,P波和R波,或者其不存在)而控制心脏电刺激疗法的递送。尖端电极42、远侧基于壳体的电极22和近侧基于壳体的电极24可以电耦接到疗法递送电路84以用于将电刺激脉冲递送到患者心脏,并且电耦接到感测电路86以用于感测心脏电信号。
感测电路86可以包含心房(A)感测通道87和心室(V)感测通道89。远侧基于壳体的电极22和近侧基于壳体的电极24可以耦接到心房感测通道87以感测心房信号,例如伴随心房肌去极化的P波。在包含两个或更多个可选择远侧基于壳体的电极的实例中,感测电路86可以包含用于将可用的远侧基于壳体的电极中的一个或多个可用的远侧基于壳体的电极选择性地耦接到包含在心房感测通道87中的心脏事件检测电路系统的开关电路系统。开关电路系统可以包含开关阵列、开关矩阵、多路复用器或适合于将感测电路86的组件选择性地耦接到所选电极的任何其它类型的开关装置。尖端电极42和近侧基于壳体的电极24可以耦接到心室感测通道89以感测心室信号,例如伴随心室肌去极化的R波。
心房感测通道87和心室感测通道89中的每一个可以包含心脏事件检测电路系统,以用于从由相应感测通道接收的心脏电信号中分别检测P波和R波。包含在通道87和89中的每个通道中的心脏事件检测电路系统可以被配置成对从所选电极接收的心脏电信号进行放大、滤波、数字化和整流,以改善用于检测心脏电事件的信号质量。每个通道87和89内的心脏事件检测电路系统可以包含一个或多个感测放大器、滤波器、整流器、阈值检测器、比较器、模数转换器(ADC)、定时器或其它模拟或数字组件。可以例如基于由控制电路80确定的存储在存储器82中和/或由控制电路80和/或感测电路86的硬件、固件和/或软件控制的定时间期和感测阈值,在控制电路80的控制下由每个相应感测通道87和89自动调整心脏事件感测阈值,例如P波感测阈值和R波感测阈值。
在基于感测阈值跨越检测心脏电事件时,感测电路86可以产生传递到控制电路80的感测到的事件信号。例如,心房感测通道87可以响应于P波感测阈值交叉而产生P波感测的事件信号。心室感测通道89可以响应于R波感测阈值交叉而产生R波感测的事件信号。控制电路80可以使用感测到的事件信号来设置对用于调度心脏起搏脉冲的基本时间间期进行控制的起搏逃逸间期定时器。取决于特定的编程起搏模式,感测到的事件信号可以触发或抑制起搏脉冲。例如,从心房感测通道87接收到的P波感测的事件信号可以使控制电路80以编程的房室(A-V)起搏间期来抑制经调度的心房起搏脉冲并且调度心室起搏脉冲。如果在A-V起搏间期到期之前感测到R波,则可以抑制心室起搏脉冲。如果A-V起搏间期在控制电路80从心室感测通道89接收到R波感测的事件信号之前截止,则控制电路80可以使用疗法递送电路84递送与感测到的P波同步的经调度心室起搏脉冲。
在一些实例中,装置10可以被配置成递送多种起搏疗法,包含心动过缓起搏、心脏再同步疗法、电击后起搏和/或心动过速相关疗法(如ATP)等。例如,装置10可以被配置成检测非窦性心动过速并且递送ATP。控制电路80可以确定心脏事件时间间期,例如,从心房感测通道87接收的连续的P波感测的事件信号之间的P-P间期、从心室感测通道89接收的连续的R波感测的事件信号之间的R-R间期,以及在P波感测的事件信号与R波感测的事件信号之间接收的P-R和/或R-P间期。可以将这些间期与心动过速检测间期进行比较,以检测非窦性心动过速。可以基于所检测到的心动过速检测间期的阈值数量,在给定的心腔中检测心动过速。
疗法递送电路84可以包含心房起搏电路83和心室起搏电路85。每个起搏电路83、85可以包含充电电路系统、一个或多个电荷存储装置(如一个或多个低电压保持电容器)、输出电容器和/或开关电路系统,所述开关电路系统控制保持电容器何时跨输出电容器充电和放电以将起搏脉冲递送到耦接到相应起搏电路83、85的起搏电极向量。尖端电极42和近侧基于壳体的电极24可以作为双极阴极和阳极对耦接到心室起搏电路85,以例如在由控制电路80设置的用于提供心房同步的心室起搏和基本的较低的心室起搏速率的A-V或V-V起搏间期到期时递送心室起搏脉冲。
心房起搏电路83可以耦接到远侧基于壳体的电极22和近侧基于壳体的电极24以递送心房起搏脉冲。控制电路80可以根据编程的较低起搏速率或根据速率响应性传感器指示的起搏速率进行设置的暂时较低速率来设置一个或多个心房起搏间期。如果在从心房感测通道87接收到P波感测的事件信号之前心房起搏间期截止,则可以控制心房起搏电路以递送心房起搏脉冲。控制电路80响应于递送的心房起搏脉冲而开始A-V起搏间期,以提供同步的多腔起搏(例如,双腔或三腔起搏)。
可以由疗法递送电路84根据从控制电路80接收到的控制信号来将心房或心室起搏电路83、85的保持电容器充电到经过编程的起搏电压幅度并且针对经过编程的起搏脉冲宽度使电容器放电。例如,控制电路80中包含的起搏定时电路可以包含可编程数字计数器,所述可编程数字计数器由控制电路80的微处理器设置以用于控制与各种单腔或多腔起搏(例如,双腔或三腔起搏)模式或抗心动过速起搏序列相关的基本起搏时间间期。控制电路80的微处理器还可以设置可以基于存储在存储器82中的编程值的心脏起搏脉冲的幅度、脉冲宽度、极性或其它特性。
可以经由遥测电路88将由控制电路80所利用的用于感测心脏事件并控制起搏疗法递送的控制参数编程到存储器82中,所述遥测电路也可以被描述为通信接口。遥测电路88包括用于使用射频通信或其它通信协议与如编程器或家用监测器等外部装置进行通信的收发器和天线。控制电路80可以使用遥测电路88从外部装置接收下行链路遥测并且将上行链路遥测发送到外部装置。在一些情况下,遥测电路88可以用于向植入患者中的另一医疗装置发射并从所述医疗装置接收通信信号。
本公开中描述的技术,包含归属于IMD 10、装置50、计算设备140和计算装置160和/或各种组成组件的技术,可以至少部分地以硬件、软件、固件或其任何组合来实施。例如,这些技术的各个方面可以在一个或多个处理器(包含一个或多个微处理器、DSP、ASIC、FPGA或任何其它等效集成或离散逻辑电路系统,以及此类组件的任何组合)内实施,其体现在编程器中,如医师或患者编程器、刺激器、图像处理装置或其它装置。术语“模块”、“处理器”或“处理电路系统”总体可以指代前述逻辑电路系统单独或与其它逻辑电路系统的组合或任何其它等效的电路系统中的任何电路系统。
此类硬件、软件和/或固件可以在同一装置内或在单独的装置内实现,以支持本公开中描述的各种操作和功能。另外,任何所描述的单元、模块或组件可以一起或以离散但可互操作的逻辑装置的形式单独实施。将不同特征描绘为模块或单元旨在突出不同的功能方面,并且不一定暗示此类模块或单元必须由单独的硬件或软件组件来实现。相反,与一个或多个模块或单元相关联的功能可以由单独的硬件或软件组件来执行,或者集成在共同的或单独的硬件或软件组件中。
当以软件实施时,归因于本公开中所描述的系统、装置和技术的功能可以体现为如RAM、ROM、NVRAM、EEPROM、闪速存储器、磁数据存储介质、光学数据存储介质等计算机可读介质上的指令。指令可以由处理电路系统和/或一个或多个处理器执行,以支持本公开中描述的功能的一个或多个方面。
出于所有目的,本文所引用的所有参考文献和出版物均通过引用全文明确地并入本文,除非并入的任何方面与本公开直接矛盾。
除非另有说明,否则本文中使用的所有科学和技术术语具有本领域中通常使用的含义。本文提供的定义是为了促进对本文中经常使用的某些术语的理解,并不意味着限制本公开的范围。
除非另有说明,否则在说明书和权利要求书中使用的所有表示特征大小、数量和物理性质的数字都可以理解为被术语“完全”或“约”修饰。因此,除非有相反的指示,否则前述说明书和所附权利要求书中所示的数值参数是近似值,其可以根据本领域的技术人员利用本文公开的教导或例如在实验误差的典型范围内寻求获得的所需性质而变化。
通过端点列举的数值范围包括纳入所述范围内的所有数字(例如,1至5包括1、1.5、2、2.75、3、3.80、4和5)以及所述范围内的任何范围。在本文中,术语“至多”或“不大于”一个数字(例如,至多50)包括此数字(例如50),并且术语“不小于”一个数字(例如,不小于5)包括此数字(例如5)。
术语“耦接”或“连接”是指元件彼此直接连接(彼此直接接触)或间接连接(在两个元件之间具有一个或多个元件并将其连接)。这两个术语都可以通过“操作性地”和“可操作地”进行修改,它们可以互换使用,以描述耦接或连接配置成允许组件交互以执行至少某些功能(例如,可以将第一医疗装置可操作地耦接到另一医疗装置从而以数据形式发送信息或从中接收数据)。
与方向有关的术语,例如“顶部”、“底部”、“侧”和“端”,用于描述部件的相对定位,并不意味着限制所考虑的实施例的方向。例如,被描述为具有“顶部”和“底部”的实施例也包括其沿各种方向旋转的实施例,除非内容清楚地另外指出。
提及“一个实施例(one embodiment)”、“一个实施例(an embodiment)”、“某些实施例(certain embodiments)”或“一些实施例(some embodiments)”等意味着结合实施例描述的特定特征、配置、组成或特性包括在本公开的至少一个实施例中。因此,这些短语在全文中各个地方的出现不一定是指本公开的同一实施例。此外,在一个或多个实施例中,可以以任何适合的方式组合特定特征、配置、组成或特性。
如本说明书和所附权利要求书中所使用的,除非文中另外明确指明,否则单数形式的“一个(a)”、“一种(an)”以及“所述(the)”包括具有多个指代物的实施例。除非内容另外明确规定,否则如本说明书和所附权利要求书中所使用,术语“或”通常在其意义上用来包含“和/或”。
如本文所用,“具有(have)”、“具有(having)”、“包含(include)”、“包含(including)”、“包括(comprise)”、“包括(comprising)”等都是以其开放式含义使用的,并且通常意味着“包含但不限于”。应当理解,“基本上由……组成”、“由……组成”等包含在术语“包括”等之中。
术语“和/或”是指一个或所有列出的元素或至少两个列出的元素的组合。列表跟随的短语“至少一个”、“包括至少一个”和“一个或多个”指的是列表中的任何一项以及列表中两个或更多个项目的任何组合。
说明性实施例
实施例1:一种系统,其包括:
电极设备,所述电极设备包括靠近患者的皮肤安置的多个外部电极,其中所述多个外部电极包括定位于所述患者的躯干左侧的多个左外部电极;以及
计算设备,所述计算设备包括处理电路系统并且耦接到所述电极设备并且被配置成:
在所述患者的心脏的固有激活期间使用所述电极设备的所述多个外部电极测量替代心脏电激活时间,其中所述替代心脏电激活时间表示传播穿过所述患者的所述躯干的心脏组织去极化,
基于测得的替代心脏电激活时间生成电异质性信息(EHI),其中所述EHI包括基于使用所述多个左外部电极测量的所述替代心脏电激活时间的左侧激活时间生成的一个或多个左度量,并且
至少基于所述一个或多个左度量来确定心脏传导系统起搏疗法是否将有益于所述患者。
实施例2:一种方法,其包括:
在患者的心脏的固有激活期间使用靠近所述患者的皮肤安置的多个外部电极测量替代心脏电激活时间,其中所述多个外部电极包括定位于所述患者的躯干左侧的多个左外部电极,其中所述替代心脏电激活时间表示传播穿过所述患者的所述躯干的心脏组织去极化,
基于测得的替代心脏电激活时间生成电异质性信息(EHI),其中所述EHI包括基于使用所述多个左外部电极测量的所述替代心脏电激活时间的左侧激活时间生成的一个或多个左度量,并且
至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者。
实施例3:根据实施例1和2中任一项所述的系统或方法,其中所述患者的心脏传导系统从位于所述患者的窦房结或房室结附近的近侧区域延伸到位于所述患者的限定心脏传导网络的浦肯野纤维附近的远侧区域,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括确定心脏传导系统阻滞是否被定位成沿所述心脏传导网络相比于所述远侧区域更靠近所述近侧区域。
实施例4:根据实施例1至3中任一项所述的系统或方法,其中所述一个或多个左度量包括大于或等于左侧晚期激活阈值的左侧激活时间的左侧晚期激活百分比。
实施例5:根据实施例4所述的系统或方法,其中所述左侧晚期激活阈值大于或等于40毫秒。
实施例6:根据实施例4和5中任一项所述的系统或方法,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括:如果所述左侧激活时间的左侧晚期激活百分比大于或等于40%,则确定所述心脏传导系统起搏疗法将有益于所述患者。
实施例7:根据实施例1至6中任一项所述的系统或方法,其中所述一个或多个左度量包括所述左侧激活时间的左平均值。
实施例8:根据实施例7所述的系统或方法,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括:如果所述左侧激活时间的所述左平均值大于或等于50毫秒,则确定所述心脏传导系统起搏疗法将有益于所述患者。
实施例9:根据实施例1至8中任一项所述的系统或方法,其中所述心脏传导系统起搏疗法包括一种或多种心房至心室(VfA)起搏疗法、希氏束起搏疗法、左束支区起搏和间隔内左心室心内膜起搏。
实施例10:一种系统,其包括:
电极设备,所述电极设备包括靠近患者的皮肤安置的多个外部电极,其中所述多个外部电极包括定位于所述患者的躯干左侧的多个左外部电极;以及
计算设备,所述计算设备包括处理电路系统并且耦接到所述电极设备并且被配置成:
在所述患者的心脏的固有激活期间使用所述电极设备的所述多个外部电极测量替代心脏电激活时间,其中所述替代心脏电激活时间表示传播穿过所述患者的所述躯干的心脏组织去极化,
基于测得的替代心脏电激活时间生成电异质性信息(EHI),其中所述EHI包括基于使用所述多个左外部电极测量的所述替代心脏电激活时间的左侧激活时间生成的一个或多个左度量,并且
至少基于所述一个或多个左度量来确定心脏传导系统阻滞是否被定位成沿所述患者的心脏传导网络相比于远侧区域更靠近近侧区域,其中所述患者的心脏传导系统从位于所述患者的窦房结或房室结附近的所述近侧区域延伸到位于所述患者的浦肯野纤维附近的所述远侧区域。
实施例11:根据实施例10所述的系统,其中所述一个或多个左度量包括大于或等于左侧晚期激活阈值的左侧激活时间的左侧晚期激活百分比。
实施例12:根据实施例11所述的系统,其中所述左侧晚期激活阈值大于或等于40毫秒。
实施例13:根据实施例11和12中任一项所述的系统,其中至少基于所述一个或多个左度量来确定心脏传导系统阻滞是否被定位成沿所述患者的心脏传导网络相比于所述远侧区域更靠近所述近侧区域包括:如果所述左侧激活时间的左侧晚期激活百分比大于或等于40%,则确定所述心脏传导系统阻滞相比于所述远侧区域更靠近所述近侧区域。
实施例14:根据实施例10至13中任一项所述的系统,其中所述一个或多个左度量包括所述左侧激活时间的左平均值。
实施例15:根据实施例14所述的系统,其中至少基于所述一个或多个左度量来确定心脏传导系统阻滞是否被定位成沿所述患者的心脏传导网络相比于所述远侧区域更靠近所述近侧区域包括:如果所述左侧激活时间的所述左平均值大于或等于50毫秒,则确定所述心脏传导系统阻滞相比于所述远侧区域更靠近所述近侧区域。
实施例16:根据实施例10至16所述的系统,其中所述心脏传导系统起搏疗法包括一种或多种心房至心室(VfA)起搏疗法、希氏束起搏疗法、左束支区起搏和间隔内左心室心内膜起搏。
实施例17:一种系统,其包括:
电极设备,所述电极设备包括靠近患者的皮肤安置的多个外部电极,其中所述多个外部电极包括定位于所述患者的躯干左侧的多个左外部电极;
显示器,所述显示器包括图形用户界面以呈现用于帮助用户评估所述患者是否将受益于心脏传导系统起搏疗法的信息;以及
计算设备,所述计算设备包括处理电路系统并且耦接到所述电极设备和所述显示器并且被配置成:
允许所述用户在所述图形用户界面上启动心脏传导系统起搏疗法益处确定,
响应于所述用户启动所述心脏传导系统起搏疗法益处确定,在所述患者的心脏的固有激活期间使用所述电极设备的所述多个外部电极测量替代心脏电激活时间,其中所述替代心脏电激活时间表示传播穿过所述患者的所述躯干的心脏组织去极化,
基于测得的替代心脏电激活时间生成电异质性信息(EHI),其中所述EHI包括基于使用所述多个左外部电极测量的所述替代心脏电激活时间的左侧激活时间生成的一个或多个左度量,并且
在所述图形用户界面上显示至少基于所述一个或多个左度量的对所述心脏传导系统起搏疗法是否将有益于所述患者的指示。
实施例18:根据实施例17所述的系统,其中所述患者的心脏传导系统从位于所述患者的窦房结或房室结附近的近侧区域延伸到位于所述患者的限定心脏传导网络的浦肯野纤维附近的远侧区域,其中至少基于所述一个或多个左度量的对所述心脏传导系统起搏疗法是否将有益于所述患者的指示包括对心脏传导系统阻滞沿所述心脏传导网络的位置的指示。
实施例19:根据实施例17至18中任一项所述的系统,其中所述计算设备被进一步配置成在所述图形用户界面上显示所述一个或多个左度量。
实施例20:根据实施例17至18中任一项所述的系统,其中所述一个或多个左度量包括大于或等于左侧晚期激活阈值的左侧激活时间的左侧晚期激活百分比。
Claims (8)
1.一种系统,其包括:
电极设备,所述电极设备包括靠近患者的皮肤安置的多个外部电极,其中所述多个外部电极包括定位于所述患者的躯干左侧的多个左外部电极;以及
计算设备,所述计算设备包括处理电路系统并且耦接到所述电极设备并且被配置成:
在所述患者的心脏的固有激活期间使用所述电极设备的所述多个外部电极测量替代心脏电激活时间,其中所述替代心脏电激活时间表示传播穿过所述患者的所述躯干的心脏组织去极化,
基于测得的替代心脏电激活时间生成电异质性信息(EHI),其中所述EHI包括基于使用所述多个左外部电极测量的所述替代心脏电激活时间的左侧激活时间生成的一个或多个左度量,并且
至少基于所述一个或多个左度量来确定心脏传导系统起搏疗法是否将有益于所述患者。
2.根据权利要求1所述的系统,其中所述患者的心脏传导系统从位于所述患者的窦房结或房室结附近的近侧区域延伸到位于所述患者的限定心脏传导网络的浦肯野纤维附近的远侧区域,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括确定心脏传导系统阻滞是否被定位成沿所述心脏传导网络相比于所述远侧区域更靠近所述近侧区域。
3.根据权利要求1至2中任一项所述的系统,其中所述一个或多个左度量包括大于或等于左侧晚期激活阈值的左侧激活时间的左侧晚期激活百分比。
4.根据权利要求3所述的系统,其中所述左侧晚期激活阈值大于或等于40毫秒。
5.根据权利要求3至4中任一项所述的系统,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括:如果所述左侧激活时间的左侧晚期激活百分比大于或等于40%,则确定所述心脏传导系统起搏疗法将有益于所述患者。
6.根据权利要求1至5中任一项所述的系统,其中所述一个或多个左度量包括所述左侧激活时间的左平均值。
7.根据权利要求6所述的系统,其中至少基于所述一个或多个左度量来确定所述心脏传导系统起搏疗法是否将有益于所述患者包括:如果所述左侧激活时间的所述左平均值大于或等于50毫秒,则确定所述心脏传导系统起搏疗法将有益于所述患者。
8.根据权利要求1至7中任一项所述的系统,其中所述心脏传导系统起搏疗法包括一种或多种心房至心室(VfA)起搏疗法、希氏束起搏疗法、左束支区起搏和间隔内左心室心内膜起搏。
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