CN100548211C - 用于可植入心脏治疗装置的多个电极向量 - Google Patents
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Abstract
本发明的可植入心脏治疗系统能够选择最合适的电极向量以在特定患者内进行感测。在某些实施方案中,可植入心脏治疗系统根据哪一个电极向量导致最大的信号振幅,或者诸如信噪比(SNR)这样的其它一些有用的度量,而确定用于连续感测的最合适的电极向量。当使用所述度量测量时拥有最高质量的电极向量然后被设置成用于感测的缺省电极向量。另外,在本发明的某些实施方案中,根据通常与缺省电极向量正交来选择下一个替代的电极向量。在本发明的又一些其它的实施方案中,根据拥有在缺省电极向量之后的下一个最高质量度量而选择下一个替代电极向量。在一些实施方案中,如果缺省向量的分析是不确定的,则下一个替代的电极向量被分析以减小不确定性。
Description
相关申请的参考
本申请要求2003年7月28日提交的、名称为“MULTIPLEELECTRODEVECTORS IN A SUBCUTANEOUS ICD(皮下ICD中的多个电极向量)”、序列号为No.60/490,779的美国临时申请的权益。该申请也是2004年5月27日提交的、名称为“METHOD FOR DISCRIMINATINGBETWEEN VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS(用于区别室性和室上性心律失常的方法)”的共同未决美国专利申请No.10/856,084的部分继续申请,上述申请要求2003年5月29日提交的序列号为No.60/474,323的美国临时申请的权益。该申请也是2004年6月8日提交的、名称为“APPARATUS AND METHOD OF ARRHYTHMIADETECTION IN A SUBCUTANEOUS IMPLANTABLECARDIOVERTER/DEFIBRILLATOR(在皮下可植入复律器/除颤器中检测心律失常的装置和方法)”、序列号为No.10/863,599的共同未决美国申请的部分继续申请,该申请是2001年11月21日提交的、名称为“APPARATUS AND METHOD OF ARRHYTHMIA DETECTION IN A SUBCUTANEOUSIMPLANTABLE CARDIOVERTER/DEFIBRILLATOR(在皮下可植入复律器/除颤器中检测心律不齐的装置和方法)”、序列号为No.09/990,510的美国申请的继续申请,即现在的美国专利No.6,754,528。该申请也是2004年6月1日提交的、名称为“METHOD AND DEVICES FOR PERFORMINGCARDIAC WAVEFORM APPRAISAL(用于进行心脏波形评估的方法和装置)”的美国专利申请No.10/858,598的部分继续申请,上述申请要求2003年6月2日提交的、序列号为No.60/475,279的美国临时申请的权益。所有这些申请的公开内容都援引于此以作参考。
技术领域
本发明总地涉及用于改进可植入心脏治疗系统中的感测的方法和装置。更具体地,本发明涉及在患者体内的限定位置处将电极放置到可植入起搏或复律器/除颤器系统中以产生用于改进的远场感测和改进心脏事件的感测的多个电极向量。
背景技术
可植入心节律管理装置是管理特定患者中的不规律心节律的一种有效治疗。可植入心节律管理装置能够用多种治疗方法来识别和治疗心律失常。这些治疗方法包括用于治疗心动过缓的抗心动过缓起搏、用于治疗室性心动过速的抗心动过速起搏或心脏复律脉动,和用于治疗室性纤颤的高能量电击。通常,心节律管理装置按顺序提供这些治疗方法以治疗心动过速:从抗心动过速起搏开始,然后进行低能量电击,之后,最后是高能量电击。不过有时根据所检测的快速性心律失常而仅选择这些疗法中的一种。
为了有效地提供治疗,心节律管理装置必须首先准确地对心脏事件进行检测和分类。通过心脏事件的精确分类,这些心节律管理装置能够对正发生的心律失常(若有的话)的类型进行分类,并且评估合适的疗法以提供给心脏(如果被指示的话)。不过,当心节律管理装置误分类一个事件,并且作为结果,提供不适当的疗法或未能提供疗法时就产生了问题。
当心节律管理装置提供不适当的治疗时,除了为患者带来身体疼痛之外,也是极其令人不安的。而且,提供不适当的疗法可能加重心脏心律失常的严重程度或者导致原来未患有心律失常的人产生心律失常。所以,感测体系结构的精度是保证为患者提供适当疗法的重要因素。
发明内容
在第一实施方案中,一种可植入心脏治疗系统配备有布置在患者胸腔中若干位置处的电极。在系统的操作期间,各种感测向量可以周期地、重复地或连续地被监视以选择用于事件检测和分类的最佳感测向量。可以选择一个感测向量,然后该感测向量用于分析。在另一个实施方案中,多个向量可以同时被分析以提供分层或分优先级的检测方案,或对较高优先级向量提供二次检查。例如,第一向量可以用作较高优先级向量,第二向量可以用于验证用第一向量所感测的结果。作为另一选择,可以通过使用第二向量来检验第一向量而减小不确定性。另外的实施方案包括可植入心脏治疗系统和用在适于执行这些方法的可植入心脏治疗系统中的操作电路。一些实施方案采用皮下可植入心脏治疗系统的形式。
附图说明
图1A-1B分别示出了代表性的皮下和静脉内可植入心脏治疗系统;
图2显示了具有一个替代的皮下电极系统布置的皮下可植入心脏治疗系统;
图3A和3B显示了用于放置可植入心脏治疗装置的三个位置和用于放置电极的四个皮下位置;
图4示出了带有放置在旁胸骨处的电极的侧向放置的可植入心脏治疗系统;
图5示出了带有放置在旁胸骨处的电极的胸部放置的可植入心脏治疗系统;
图6A-6F描绘了从若干离散的电极内距离的记录的心电图;
图7显示了根据观察到的模糊信号来确定周期以评估最佳电极向量的向量感测评估的框图;以及
图8A和8B显示了感测心脏去极化向量的两个电极向量之间的关系。
具体实施方案
应当参考附图阅读下面具体的说明,其中不同附图中相似的元件等同地用相似的数字编号。并不一定按比例的这些附图描述选择的实施方案,并且不想限制本发明的范围。本领域技术人员将理解许多例子和所述例子的元件具有可以利用的合适替换方式。
本发明总地涉及用于对患有特定心律失常的患者提供治疗的心节律管理装置(例如可植入心脏复律器/除颤器(ICD)系统)。本发明致力于用于心节律管理装置中的感测体系。尤其是,本发明适用于能够对有害的心律失常进行检测和除颤的ICD系统。虽然该感测体系主要打算用在提供除颤治疗的可植入医学装置中,但本发明也能够应用于针对抗快速性心律失常起搏(ATP)疗法、心脏起搏的心节律管理装置,和其他能够执行组合治疗以治疗节律紊乱的心节律装置,包括外部装置中。
至今,ICD系统一直是心外膜系统或经静脉的系统,其通常如图1B所示地被植入,不过,如这里进一步说明的,本发明也适合于与图1A所示的皮下ICD系统一起工作。
图1A表示皮下放置的ICD系统。在这个说明性实施方案中,心脏1用耦合到引线系统(lead system)3上的盒体2进行监视。盒体2可包括其上的电极4,而引线系统3与感测电极5、6以及线圈电极7连接,线圈电极7可作为电击或刺激传递电极和感测电极。各电极之间的一般路径限定了多个感测向量V1、V2、V3、V4。可以看到,每个向量提供了心脏1中电活动的不同向量“视图”。该系统可以如例如美国专利US6,647,292和US6,721,597描述的那样被在皮下植入,这两篇专利文献的公开内容包括在这里作为参考。通过在皮下放置,这意味着通过不要求将电极插入到心室、心肌或患者的脉管系统中的电极放置便可完成感测和治疗。
图1B表示经静脉的ICD系统,心脏10由包括盒体11的系统监测和治疗,该盒体耦合到包括心房电极13和心室电极14的引线系统12上。可以采用该电极的多种配置,包括放置在心脏内、贴附在心脏上,或布置在患者的脉管系统中。例如,Olson等在美国专利US6,731,978中描述了布置在心脏各个腔室中用于感测的电极,和除感测电极之外的电击电极。
在一些实施方案中本发明也通过操作电路体现,所述操作电路包括设在盒体2(图1A)或盒体11(图1B)中的选择电部件。在这种实施方案中,操作电路可被配置为使得能够执行所述方法。在一些类似的实施方案中,本发明可以以可读取指令集体现,例如在机器或控制器可读取介质中编码的程序,其中提供可读取指令集,使得操作电路能够执行与各种实施方案管理的在此所讨论的分析。另一些实施方案可包括适于读取和执行这里所讨论的实施方案的控制器或微控制器。
在图1A所示的系统中,皮下可植入心脏治疗装置可以感测多个电极向量。尤其是,所示的配置至少可以在第一感测电极6和盒体或外壳电极4之间进行感测。盒体或外壳电极4可以是外壳或盒体的一部分,外壳或盒体本身可以是电极4,或者作为另一选择,电极可以附接到外壳或附接在外壳上。该感测关系形成电极向量v1。该装置可以进一步在第一感测电极6和第二感测电极5之间进行感测以形成电极向量v2。第三感测配置通过在第二感测电极5和盒体电极4之间进行感测而产生。该感测关系形成电极向量v3。最后说明的电极向量是在电击电极7和盒体电极4之间,从而形成电极向量v4。图1a中所示的系统仅仅是示例性的。该图的目的是表明可以通过可植入复律器-除颤器系统,尤其通过皮下系统形成的一些可能的电极向量。在不偏离本发明的精神和范围的情况下也可以利用其它电极布置和电极类型。
图2中显示了一个替代的皮下实施方案。盒体18电地耦合到电极19、20、22,使电极19、20布置在导线24上并且电极22布置在盒体18上。若干电极19、20、22提供了围绕心脏26的各种感测向量。示例性的导线和电极可以具有各种长度。如下面进一步所讨论的,某些尺寸和长度可以提供有利的感测特性。
图3A和3B显示了用于将ICD放置到患者胸部中的三个示例性皮下位置(X,Y和Z)。图3A是从正面看去、面对患者胸部的视图,而图3B是从患者的左侧看去的视图,每个视图仅仅显示了ICD部件和心脏。位置X布置在胸腔的左侧,低于手臂,并且在此被指定为侧向位置。位置Y是前部位置,低于乳房下皱褶(inframammary crease,IC),并且在此被指定为乳房下位置。最后,位置Z也是前部位置并且对应于ICD的常规定位。此位置位于心脏(H)的左上方和锁骨(CB)下方。该位置Z在此被指定为胸位置。
类似地,图3A和3B显示了用于将皮下电极系统12放置到患者胸部上的四个皮下位置(A,B,C和D)。位置A是位于胸骨(ST)左侧上的旁胸骨放置。位置B是平行于胸骨(ST)延伸的电极放置,但是位置B在侧面与位置A的旁胸骨放置相对。位置C是大体与位置A和B正交的电极放置,并且定位在心脏(H)上方的线上。最后,位置D是平行于位置C的电极放置,但是具有位于患者心脏(H)下方的线中的电极。
图4示出了带有沿着导线32放置在旁胸骨处(位置A)的皮下电极系统的侧向放置(X)的ICD盒体30。图4显示了沿着胸腔在皮下横穿并且在这样一个位置终止的导线32,在所述位置导线32的皮下电极系统垂直地布置并且平行于患者的胸骨(ST)。第一感测电极34被显示成位于患者心脏(H)上方的线处或其附近。也显示了线圈电极35,该线圈电极35被耦合以用作电击电极,并且可选择地,作为附加感测电极。
图5类似地示出了在胸部放置(Z)的ICD盒体36,其带有包括导线38的在旁胸骨处放置(位置A)的皮下电极系统。图5也显示了导线38沿着胸腔在皮下横穿的导线38并且该导线终止使得导线38的皮下电极系统垂直并且平行于患者的胸骨(ST)地布置。与图3中的电极放置相比,皮下电极系统的第一感测电极40位于患者心脏(H)之下的线处或其附近。再次地,也示出了用作电击电极或需要时用作感测电极的线圈电极41。
围绕患者胸部的皮下空间固有地是曲线形的。由于盒体30、36(其可以包括感测电极)和导线32、38上的皮下电极系统定位在该区域上,因此用于ICD的电极、盒体和导线相对彼此很少是平坦的(如果有的话)。因此各种向量可以被定义为与心脏(H)相交,而不一定必须在心脏(H)中放置电极。
分离盒体30、36和导线32、38上的电极的距离取决于患者的身体结构。使用图4和5中所示的配置,在典型的成人患者中,盒体30、36的中心离导线32、38上的电击线圈35、41的中心为大约8cm至大约19cm。根据本发明的儿童接收装置可以具有通常不大于约4cm的盒体和电击线圈35、41之间的间距。
本发明的皮下实施方案从优化电极内距离以使心脏电活动的感测最大化的能力受益。由于本发明的皮下实施方案并不受电极位于所述系统内或患者的胸部内的位置的限制,所以皮下系统可以使用特别选择用于优化远场信号感测的电极内距离,或者可以改变操作期间的感测电极对以优化感测。
图6A-6F描绘了从具有不同电极内距离的两个小表面积电极观察到的心电图(EKG)信号。在这些图中,两个小表面积电极中的一个放置在侧向地距胸骨0.5”定位的固定位置,并且在患者的心脏上方。两个小表面积电极中的第二个位于离第一电极的特定距离处以观察和记录所产生的EKG中的变化。
初始地,第二电极侧向地放置在离固定电极0.75”处,由此产生大约0.75”的电极内距离。然后观察心脏电活动的EKG。图6A表示所记录的EKG的一部分,其中电极拥有大约0.75”的电极内距离。在离固定电极位置大约1.25”,2”,2.5”,3.25”和5.5”处侧向地定位第二电极之后,另外的EKG被记录以测量感测的心脏活动。所产生的EKG分别在图6B-6F中示出。平均的观察到的QRS复合波的振幅在图6A中大约为1.0mV,在图6B中大约为2.0mV,对于图6C大约为4.4mV,对于图6D大约为5.5mV,对于图6E大约为7.8mV,且对于图6F大约为9.6mV。
本发明的皮下实施方案并不将电极的位置限制在静脉内或心脏内位置。同样,皮下系统可以使用特别选择用于优化远场信号感测的电极内距离。在图6A-6F中可以观察到,增加电极内距离导致信号振幅显著增加。在图6B和图6A中记录的心脏电活动之间观察到100%的振幅增加。在图6C和图6A中记录的心脏电活动之间观察到340%的振幅增加。在图6D和图6A中记录的心脏电活动之间观察到450%的振幅增加。在图6E和图6A中记录的心脏电活动之间观察到680%的振幅增加。最后在图6F和图6A中记录的心脏电活动之间观察到860%的振幅增加。
本领域的技术人员应当理解,所期望的是在感测时获得可能的最高信号振幅。具体而言,由于检测的心脏电信号被处理以对特定节律进行分类,因此心脏电信号越大,正确地分类节律的机会越大。本发明的一些实施方案通过使用特别选择的用于优化远场信号感测的电极内距离而提供了正确分类心律失常的更大机会。
本发明的一些实施方案进一步能够选择在特定患者体内进行感测的最合适的电极向量。在一个实施方案中,在植入之后(参考图1),ICD被编程以在若干可用的电极向量-v1,v2,v3和v4之间进行感测。然后ICD系统使用一些或所有可用的电极向量或者预设数量的可用电极向量来感测一系列心脏信号。在某些实施方案中,ICD系统然后根据哪一个电极向量导致最大信号振幅,或者使用诸如信噪比(5NR)这样的其它一些度量来最佳地执行,而确定用于连续感测的最合适电极向量。拥有最高质量度量(例如振幅或5NR)的电极向量然后被设置成用于连续感测的缺省电极向量。在某些实施方案中,根据通常与缺省的电极向量正交的那些来选择下一个替代的电极向量。例如,如果电极向量v3被选择作为缺省向量,则下一个替代电极向量可以是v2,一个通常与v3正交的电极向量。在另外的其它实施方案中,根据在缺省电极向量之后拥有下一个最高质量度量而选择下一个替代电极向量。
认识到患者身体结构不同,本发明并不打算被限于纯粹地或严格地正交的感测向量。在一些实施方案中,通常当两个感测向量产生一个角度使得所述角度的余弦的大小小于大约0.7时,认为存在大体上正交的感测向量。在另一个实施方案中,所述角度的余弦的大小小于大约0.5。在进一步的实施方案中,所述角度的余弦的大小小于大约0.3。当在此使用时,当应用于诸如角度的余弦这样的标量值时短语“的大小”表示绝对值。在此使用该角分析是因为:尽管两个向量可以限定一个平面,但两个向量的相交可以限定多个角。在余弦方面的分析保证了相同的结果,而不管为了确定它们之间的角度,所述向量相对于彼此如何布置。仅仅在第一象限角中考虑,上述的余弦值产生大约45度至大约90度、大约60度至90度之间的角度和大约72度至90度之间的角度。
在本发明的一个实施方案中,ICD系统根据对所有感测的信号执行的操作的结果来确定最合适的电极向量。ICD系统对使用ICD系统的检测体系从每个可能的电极向量接收的感测信号独立地操作。例如,ICD系统可以通过相关波形分析或类似的操作功能而运行来自每个电极向量的所有信号。具体而言,ICD系统在电极向量v1,v2,v3和v4上独立地执行相关波形分析。ICD系统然后评估来自每个独立被操作的信号的结果。该评估程序确定了产生用于提供一个判决的最高质量度量的电极向量.最后,ICD系统选择产生最高质量度量的电极向量作为用于连续感测的缺省电极向量。例如,如果电极向量v3从被评估的四个电极向量产生最高质量度量,则ICD系统将选择电极向量v3作为缺省电极向量。
在某些实施方案中,ICD系统排列(根据执行的层级而分优先级)电极向量。通过排列电极向量,当在缺省电极向量的分析中产生不确定性时,ICD系统可以利用替代的电极向量,尤其是下一个最佳执行的电极向量。
对于本发明的某些实施方案,用于感测的最佳电极向量的评估由医生周期性地更新。响应于ICD系统的编程器可以接收来自ICD系统的传输。尤其是,来自编程器的传输表征由每个电极向量感测的心脏活动。然后医生可以选择用于特定患者的最佳电极向量并且将那个被选择的电极向量设置成缺省的。编程器可以另外地使医生能够例如在来自缺省电极向量的信号受到损害的情况下,选择替代方案。另外,编程器可以选择最佳电极向量和根据从ICD系统接收的传输而自动地选择替代方案。
在本发明的又一些替代的实施方案中,无论是先验地(例如通过信号振幅)还是追溯地(例如在对未处理的信号数据进行操作之后)作出判决,用于感测的最佳电极向量的评估被周期性地由ICD系统更新。例如,初始地使用电极向量v1来感测最高质量度量(例如最高振幅信号)。但是,在植入一段时间之后,ICD系统可以确定当通过电极向量v2感测时经历最高的质量度量。相反地,可以周期性地确定在所述装置的整个寿命期间最佳电极向量继续保持为电极向量v1。
先验更新的一个例子将是随着时间过去而为若干向量中的每一个测量SNR。如果在植入之后形成肌肉伪影,或者如果在其中一个感测电极周围形成纤维性形态,那么若干感测向量的相关SNR可能随着时间而改变。如果其中一个感测电极提供了优于初始选择的向量的SNR,那么以后的更新可以选择不同的向量。
追溯更新的例子将是为一段时间周期选择特定的感测向量,但是证明是不适合用于分析的,例如由于噪音伪影。例如,如2004年6月1日提交的、名称为“METHOD AND DEVICES FOR PERFORMING CARDIACVAVEFORM APPRAISAL(用于进行心脏波形评估的方法和装置)”的共同未决美国专利申请No.10/858,598中所解释的,其中所述申请被援引于此以作参考,如果使用心跳证实方案,那么一致的未能捕获被证实的心跳可能表明所选择的向量是不合适的。类似地,如果模板形成系统依赖于所捕获的数据,那么未能捕获符合所选择的证实准则的模板可能表明所选择的向量是不合适的。在这样的情况下,可以通过查看下一个最佳感测向量而选择另一感测向量。例如,如果由于第一向量具有被感测向量的最佳振幅而选择它用于感测,假设第一向量证明不适合用于模板形成,那么可以选择具有第二最佳振幅的第二向量。
用于评估最佳电极向量的周期性优选地根据所感测的心脏电信号是否对ICD系统的检测体系是不确定的。关于本发明,不确定性涉及所感测的心脏电信号是否难以被ICD系统的检测体系领会、理解或分类。该过程在图7中作为例子示出。
现在参考图7,心脏电信号通过电极向量v1被感测。感测的信号然后被ICD系统的检测体系操作。然后评估该操作的结果。在某些实施方案中,ICD系统将评估被操作的信号是否明确地等同于正常窦性节律。如果操作的结果明确地指示正常窦性节律,那么ICD系统重复所述程序并且感测另一待操作的心脏电信号。然而,如果操作的结果是不确定的,或者被操作的信号指示正常窦性之外的节律,那么所述过程进入第二阶段50。不确定性的一些示例性说明可以在2004年5月27日提交的、名称为“METHOD FOR DISCRIMINATIING BETWEEN VENTRICULAR ANDSUPRAVENTRICULAR ARRHYTHMIAS(用于区别室性和室上性心律失常的方法)”的美国专利申请No.10/856,084中找到,所述申请被援引于此以作参考。
在第二阶段50中,下一个心脏电信号的及时感测通过一个替代的电极向量被执行。在一些实施方案中,用于该感测的所述替代的电极向量是通常与用于感测前一信号的电极向量正交的电极向量。例如,如果通过电极向量v1感测前一心脏电信号,那么将可以通过电极向量v2感测下一心脏电信号。在本发明的替代实施方案中,其余电极向量中的任何一个都可以用来在第二阶段50中用于感测下一个心脏电信号。例如,可以选择下一个最高振幅感测向量。
该随后感测的信号然后被ICD系统的检测体系操作。该操作的结果再次被评估。如果从该替代的电极向量所述操作结果明确地指示正常窦性节律,那么ICD系统重复所述程序并且感测另一待操作的心脏信号。在某些实施方案中,在第二阶段50之后随后感测的心脏信号继续通过在第二阶段50中用于评估的电极向量被感测。因此在前面的例子中,所有随后感测的心脏电信号将使用电极向量v2进行感测。然而,在特定的实施方案中,仅仅当第二阶段50操作的结果明确地指示正常窦性节律时这才是正确的。如果第二阶段50的结果再此是不确定的,或者被操作的信号明确地指示不同于正常窦性的节律,那么可能再一次使用缺省电极向量-在此为v1-来处理将来被感测的心脏电信号。
在又一些替代的实施方案中,在任何第二阶段50评估之后的下一个心脏电信号再次初始地通过缺省电极向量-对于此例为v1-被感测。在此实施方案中,利用第二阶段50及其替代的电极向量,缺省电极向量仅仅在一系列明确的评估之后被改变。
本发明的ICD装置也可以连续地和/或彼此独立地在多个电极向量之间感测。该能力允许本发明及时从多个向量视点评估相同的心脏电信号。另外,该能力允许ICD系统根据观察到的不明确信号评估最佳电极向量而不会未能操作和评估每个感测的心脏信号。具体而言,心脏电信号通过电极向量,例如v1而被感测。所感测的信号然后被ICD系统的检测体系操作。然后评估该操作的结果。如果操作的结果是不确定的,或者被操作的信号明确地指示正常窦性之外的节律,那么所述过程进入第二阶段50。
在该实施方案的第二阶段50中,在与已经评估的样本相同时间、但是用不同的电极感测的心脏电信号被评估。所以,以前被操作的信号和将在第二阶段50中被操作的信号同时发生-尽管是通过不同的电极向量被采集的。来自v2的所感测的信号然后被ICD系统的检测体系操作。再次评估该操作的结果。如果在该第二电极向量中操作的结果明确地指示正常的窦性节律,那么ICD系统重复所述程序并且感测待操作的另一心脏电信号。
在多个感测向量之间感测的普通能力特别地增强了区分心律失常的检测体系的特异性。具体而言,在多个电极向量之间感测增强了区分心律失常的起因和类型的特异性。在本发明的一个例子中,代表正常窦性节律(NSR)的心脏复合波从电极向量v1和电极向量v2中的每一个被捕获,然后被存储。这些分别被存储为NSR模板1和NSR模板2。由于电极向量v1和v2对心脏处在不同的角度,因此它们各自的模板可以显著不同,即使它们可能是基于相同的心脏事件。
逐个心跳地,所感测的复合波可以与它们各自的NSR模板比较。作为一个例子,在某些向量取方中心室源发的心律失常可能类似于NSR。使用仅仅感测一个电极向量的ICD系统,一些室性心律失常可能对检测体系来说是不可区别的。然而在本发明中,未能分类特定节律的机会通过使用多个视图而被减少。尤其是,尽管心室源发的心律失常可以在一个视图中类似于NSR模板,但是第二电极向量也将感测类似于其NSR模板的相同复合波是极不可能的。
心室源发的心律失常常常表现出与它们的NSR相关的极性翻转。如果此极性翻转由于一个电极向量中的定位而未被检测,那么当与其NSR模板比较时一个通常正交定位的第二电极向量将很可能感测到这样的翻转。因此该检测算法将对无典型特征的复合波,或一系列复合波进行分类,并且将所述复合波评价为室性心律失常。
在一个实施方案中,对使用缺省电极捕获的缺省电极向量的初始分析可能产生模糊结果。例如,如果执行相关波形分析以比较一个感测的信号和NSR模板,那么波形分析可能指示NSR未在发生。然而,从初始分析可能不清楚正在发生的心律失常的类型(例如,不需要治疗的室上性心律失常,或者确实需要治疗的室性心律失常)。在示例性的例子中,可以使用一个利用不同电极捕获的信号来执行第二级分析以区分可治疗和不可治疗的心律失常。然后所述方法可以返回去仅仅观察该缺省电极对。
图8A和8B表明了在感测一心脏去极化向量中两个电极向量之间的关系。更具体而言,图8A和8B用图形描述了在有源盒体64与第一感测环62之间,和在第一感测环62与第二感测环60之间,在ICD系统中形成的电极向量。这些向量分别被标记为v1和v2。图8A和8B进一步示出了心脏去极化向量M。该心脏去极化向量M不能仅仅通过测量图8A和8B中所示的两个电极向量中的一个而完整地被描述。关于心脏去极化向量M的更多信息可以使用两个电极向量而获取。因此,从三个或更多的电极导出的所得到的ECG将更精确地限定一个去极化向量M或其一小部分。
对于心脏去极化向量M,在电极向量v1的方向中感应的电压由M在v1方向中的分量给出。在向量代数中,这可以由点积表示:
υv1=M·v1
其中υv1是在电极向量v1的方向中测量的标量电压。图8A和8B进一步描绘了在空间中取向的电极向量v2。然而,当其涉及电极向量v2时,心脏去极化向量M的效果在图8A和8B之间是不同的。
图8A示出了一个心脏去极化向量M,其包括在两个向量方向中的分量,且因此用沿着两个电极向量的标量电压进行感测和测量。图8A中的心脏去极化向量M在空间中取向,使得两个电极向量v1和v2分别感测标量电压υv1和υv2。尽管标量电压υv1占主导,标量电压υv2被感测并且可以用于区分心脏去极化向量M的大小和方向的差异。
作为比较,图8B中的电极向量v2被取向成与心脏去极化向量M正交。在该实施方案中,由于v2电极向量因心脏去极化向量的结果而没有感测到电压,因此M沿电极向量v2的方向的分量为零;在v2的方向中没有感应电压。作为比较,沿v1的标量电压平行于去极化向量M并且完全捕获M。
具有断定心脏去极化向量M的能力,则图8A和8B进一步描绘了本发明可如何用于增强所感测信号的特殊属性。例如,本发明可以用于增强ICD系统的信噪比(SNR)。在示例中,假设大多数患者展示了心脏去极化向量M类似于在图8A中描绘的情况。对于这些患者,单独沿电极向量v1感测将导致足够高的SNR以感测和检测到大多数的心律失常,而向量v2提供可能相关的信息,用于感测v1的分析是否包含一些不确定性。
然而,可能有表现出心脏去极化向量M类似于在图8B中描绘的情况的患者。这些患者可以在植入时或者在形成病状之后表现出心脏去极化向量M,所述病状随着时间改变心脏去极化向量M以代表在图8B中描绘的情况。对于这些患者,单独沿电极向量v2感测将导致极低的SNR。此外,如果这是ICD系统拥有的仅有的感测向量,则ICD系统可能不能够检测出某些心律失常事件。然而,有关v2具有这样低的大小的知识指示了比仅仅分析v1更多的方向信息。
如上所述,感测灵敏度取决于心脏去极化向量M相对于感测电极取向的取向。
用于本发明的可植入医疗装置中的操作电路可以被配置成包括所选择的、所需要的或所期望的这样的控制器、微控制器、逻辑装置、存储器等以执行每个被配置的步骤。
除了用于ICD系统之外,本发明也可应用于起搏系统。例如,在起搏系统中许多电极可以布置成限定若干感测向量,并且本发明可以指导感测向量的选择和周期性更新。
在一个示例性例子中,本发明体现于一种可植入心脏治疗系统中,该系统包括一个可植入盒体,其收容操作电路和与所述操作电路电耦合的多个电极,其中该操作电路被配置和被耦合到该电极,以至少限定第一植入电极对和第二植入电极对。所述操作电路可被配置成执行以下步骤:从第一植入电极对捕获第一信号,使用该第一信号构成第一模板,从第二植入电极对捕获第二信号,使用该第二信号构成第二模板,以及使用第一和第二电极对和使用第一和第二模板来捕获信号以确定是否存在可治疗的心脏状况。
前面的说明书中已公开了由本文揭示的本发明的多个特征和优点。不过,应当理解,这种公开在许多方面只是说明性的。在不超出本发明的范围的情况下可以对具体细节,尤其是对部件的形状、大小和排列进行改变。当然,本发明的范围由权利要求表述的语言进行限定。
Claims (7)
1.一种可植入的电的心脏治疗装置,包括:
第一、第二和第三电极,该第二电极设在沿引线组件离第一电极第一距离处,第三电极设在沿引线组件离第一电极第二距离处;和
电耦合到该第一、第二和第三电极使得可以使用从中选择的任何电极对来进行感测的操作电路;
其中,所述操作电路适于执行以下步骤:
观察以下电极对中的至少两个电极之间的信号度量:第一-第二、第一-第三和第二-第三;
通过确定由所述信号度量测量时哪一对最佳地执行而选择用于心脏信号分析的缺省电极对,
其中,所述操作电路适于执行以下数据分析:
分析从缺省的电极对捕获的第一信号以确定是否:
已感测到正常的窦性节律;
已感测到心律失常;或者
存在不确定性;和
如果存在不确定性,则使用所述信号度量选择第二电极对并且分析从第二电极对捕获的第二信号。
2.如权利要求1所述的装置,其中第一电极是外壳电极。
3.如权利要求1所述的装置,其中所述操作电路适于执行以下步骤:
执行所感测的心脏信号的数据分析;
确定缺省的电极对是否正提供用于心脏信号分析的合适信号;和
如果不是,则选择不同的电极来用于心脏信号分析中。
4.如权利要求1所述的装置,其中所述操作电路适于使用其中一个电极对提供输出信号。
5.如权利要求1所述的装置,进一步包括作为所述引线组件的一部分布置的第四电极,该第四电极是线圈电极,其中所述操作电路被配置成使用第一电极和第四电极来提供输出信号。
6.如权利要求5所述的装置,其中当执行观察信号度量和选择缺省电极对的步骤时所述操作电路适于考虑包括第四电极以及第一、第二和第三电极中的任何一个的电极对。
7.如权利要求1所述的装置,其中所述操作电路适于使得该第二信号在时间上对应于该第一信号的至少一部分。
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- 2004-07-28 AT AT04779473T patent/ATE413837T1/de active
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- 2004-07-28 AU AU2004261227A patent/AU2004261227B2/en active Active
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- 2004-07-28 CN CNB2004800280897A patent/CN100548211C/zh active Active
- 2004-07-28 CA CA002534119A patent/CA2534119A1/en not_active Abandoned
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ATE413837T1 (de) | 2008-11-15 |
WO2005011809A2 (en) | 2005-02-10 |
EP1774906A1 (en) | 2007-04-18 |
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EP1659934A2 (en) | 2006-05-31 |
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AU2004261227A1 (en) | 2005-02-10 |
US20050049644A1 (en) | 2005-03-03 |
JP4477000B2 (ja) | 2010-06-09 |
JP2007500549A (ja) | 2007-01-18 |
US7627367B2 (en) | 2009-12-01 |
WO2005011809A3 (en) | 2005-05-06 |
US7392085B2 (en) | 2008-06-24 |
ES2317046T3 (es) | 2009-04-16 |
AU2004261227B2 (en) | 2010-04-29 |
US20050192507A1 (en) | 2005-09-01 |
CN1859870A (zh) | 2006-11-08 |
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