CN1342094A - 抗心动过速起搏 - Google Patents

抗心动过速起搏 Download PDF

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CN1342094A
CN1342094A CN00804477A CN00804477A CN1342094A CN 1342094 A CN1342094 A CN 1342094A CN 00804477 A CN00804477 A CN 00804477A CN 00804477 A CN00804477 A CN 00804477A CN 1342094 A CN1342094 A CN 1342094A
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M·D·莫顿·M·莫厄尔
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure

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Abstract

抗心动过速起搏的方案包括在舒张除极阈电位,或稍高于舒张除极阈施加两相刺激;在舒张除极阈电位或稍高电位开始两相或常规刺激,在夺获时减低到阈下;和在稍低于舒张除极阈电位的电平上施加两相或常规刺激。这些方案造成以较低的刺激电平获得可靠的心脏夺获,从而对心脏的损伤较小,延长电池的寿命,患者的痛苦小,治疗效果好。在使用两相心脏起搏的那些方案中,施加第一和第二刺激相,第一刺激相具有预定的极性,幅度和持续时间。第二刺激相也具有预定的极性,幅度和持续时间。两相顺序施加。与当前的想法相反,阳极刺激首先施加,阴极刺激随后。在此方式中,通过心脏肌的脉冲的传导改善,同时提高收缩力。

Description

抗心动过速起搏
本发明领域
本发明总的来说涉及带抗心动过速起搏能力的可植入心律转变器/除颤器，和/或这样的起搏方法。
本发明背景
一般可植入的心律转变器(ICD)在心律失常开始的十或二十秒钟内发出一个初始电除颤，从而挽救了无数的生命。各种改进的装置除了心律转变/除颤功能之外，还具有抗心律过速起搏的能力。这些ICD能够对一个或多种心律过速有不同的初期应答，并对于一个具体的心律失常有一个可编程的应答序列。
一般医生根据在心脏植入时确定的患者的夺获阈设定输出的电平。这个阈代表可靠地刺激患者的心脏要求的最小起搏能量。但是，由于与刺激相关的损伤，瘢痕组织在植入的起搏器导联线和心肌之间的界面上增生。这个瘢痕组织提高了患者的夺获阈。为了确保可靠的心脏的夺获，因此一般将输出的电平设定在比初期测量的夺获阈高一倍的一个最小值电平上。这种方法的缺点是，较高的刺激电平与较低的刺激电平相比会引起心脏组织的较大的损伤，因此促成了瘢痕组织的形成，从而提高了夺获阈。
较高的刺激电平也缩短了电池寿命。这是不希望的，因为电池寿命越短，植入新电池的手术越频繁。
另一个缺点是与这个较高的刺激电平相关的患者的不适的可能。这是因为，较高的刺激电平能够刺激膈丛神经，或者说引起肋间肌起搏。
最后是，由于输入阻滞(entry block)，较高的刺激效果较低。
因此需要一种用较低的刺激电平能够取得可靠的心脏夺获的ICD，从而比当前的ICD方法，对心脏的损伤更小，电池寿命延长，患者痛苦更轻，治疗的效果更大。也需要一种能够更好地诱导心脏，并能够从更大的距离诱导心脏各部分的ICD。
本发明的概述
因此，本发明的目的是提供一种带有抗心律过速起搏能力的ICD，其特征在于，在舒张期除极阈电位或稍高或稍低的电压施加刺激。
本发明的另一个目的是感知心脏夺获是否已发生，如果未发生，施加附加刺激。
本发明的另一个目的是在比造成未夺获的刺激电平稍高的电压电平上提供附加一个刺激。
本发明的另一个目的是重复刺激-感知循环直到心脏夺获发生。
本发明的另一个目的是，使用两相波形刺激。
通过提供一种带有各特征和能力的独特系统的可植入的心律变换器-除颤器，本发明实现了上述目的。
公开的各方案包括：
1.在舒张除极阈电位上或稍高电压下施加予两相刺激；
2.在舒张除极阈电位上或稍高电位开始两相刺激或常规刺激，在夺获时降低到阈下；和
3.在稍低于舒张除极阈电位设定的电平施加两相刺激。
如上所述，本发明的各抗心动过速起搏的方案能够与两相起搏结合使用。关于两相起搏的方法和装置包括，一个第一和第二刺激相，每个刺激相具有一个极性、幅度、波形和持续时间。在一个优选实施例中，两相是不同极性的。在一个替换的实施例中，两相是不同幅度的。在一个第二个替换实施例中，两相是不同持续时间的。在第三替换实施例中，第一相是斩波式波形。在第四替换实施例中，第一相的幅度是三角波形的。在第五替换实施例中，第一相是在完成心脏搏动/泵血循环后200毫秒时间上施加。在另一个优选实施例中，刺激的第一相是在一个长持续时间的最大阈下幅度上的阳极脉冲，刺激的第二相是短持续时间和高幅度的阴极脉冲。应指出的是，这些不同的实施例，能够以不同的方式结合。而且这些实施例仅是作为例子来说明，而不是限定的。
通过本发明的两相起搏获得强化的心肌功能。刺激或调节性的阴极与阳极脉冲的结合，维持了阳极起搏的传导性和收缩性的改进，同时消除了提高刺激阈的缺点。结果是一种增加传播速度的除极波。这个增加的传播速度造成优良的心脏收缩而导致血液流动改善，到折返线路的血液增加。在较低的电压电平上，改进的刺激也减少瘢痕形成，从而降低夺获阈增加的倾向；功率消耗减少，起搏器电池增加寿命；并且减少患者痛苦。
附图简介
图1A-1C是治疗心律失常的方法的例子图；
图2是导致阳极两相刺激的示意图；
图3是导致阴极两相刺激的示意图；
图4是导致继之以常规阴极刺激的低电平长持续时间的阳极刺激示意图；
图5是导致继之以常规阴极刺激的三角波形变化的低电平长持续时间的阳极刺激示意图；
图6是导致继之以常规阴极刺激的成序列施加的低电平短持续时间的阳极刺激示意图；和
图7是可用于执行本发明的实施例的可植入心律转变器/除颤器图。
优选实施例的详细说明
本发明涉及用于消除心房心律失常的抗心动过速起搏方法。图1A-1C示出治疗心律失常的方法的例子。
图1A示出第一方法。在此，在步骤102，一个传感器感知心动过速的开始。在一个优选实施例中，传感器包括一个抗心动过速的起搏的算法。然后，在步骤104，施加两相刺激。在变形实施中，该刺激或在舒张期除极阈，或在刚好高于舒张期除极阈。在步骤106，ICD感知是否已发生夺获。如果尚未发生夺获，在步骤108，刺激以稍高的电平继续。这个刺激-夺获-检查-提高刺激的循环继续直到发生夺获。如果发生夺获，在步骤110，刺激持续一个预定的时间。在一个优选实施例中，只要是心动失常存在就施加刺激。
在一个优选实施例中，以固有心率的80-100％的速率施加刺激脉冲，在每组刺激脉冲之间的约暂停一到两秒钟。然后，或增加脉冲数目，或调节脉冲之间的时间设定。例如，在一个优选实施例中，第一脉冲序列能够是在体内固有速率的80％，第二脉冲序列是82％，第三脉冲序列是84％等等。在一个优选实施例中，多个反馈回路提供数据，使得能够把电压调节到接近夺获阈。刺激继续到节律恢复。
图1B示出第二方法。在步骤112，传感器感知心动过速开始。在第二方法的不同的实施例中，在步骤114，施加出两相或常规刺激。这个电平设定在舒张除极阈电位，或稍高。在步骤116，ICD确定夺获是否发生。如果尚未发生，在步骤118，刺激以稍高的电平继续。这个刺激-夺获检查-提高刺激的循环继续直到发生夺获。如果发生夺获，在步骤120，刺激逐渐连续下降到阈以下。然后，如果失去夺获，将刺激升高到较高的电平，再逐渐连续减小。这个整个顺序重复，以致刺激电平尽可能接近夺获的最低刺激电平上徘徊。刺激继续到节律恢复，例如，直到抗心动过速的起搏算法确定不再需要起搏时。
图1C示出第三方法。步骤122，一个传感器感知心动过速的开始。在第三方法的各实施例中，在步骤124，施加两相或常规刺激。这个刺激电平设定在稍低于舒张期除极阈电位。在步骤126，ICD感知是否已发生夺获。如果尚未发生，在步骤128，刺激以稍高的电平继续。这个刺激-夺获检查-提高刺激的循环继续直到发生夺获。如果发生夺获，在步骤130，刺激以低于阈的电平继续。如果失去夺获，刺激提升到稍高电平，并逐渐连续减低。整个顺序重复，以致刺激电平尽可能接近夺获的最低刺激电平上徘徊。刺激继续到节律恢复，例如，直到抗心动过速起搏算法确定不再需要起搏时。感知
感知可以是直接的或间接的。例如，可根据传感电极的数据直接感知。本发明的ICD包括感知电路，通过一个或多个传感和/或刺激电极感知心律失常。传感电路把心脏浮动感知为通过电信号描绘的活动。例如，如业内人士所知，在心室组织的除极时发生R波，在房组织除极时发生P波。通过监视这些电信号，ICD的控制/时钟电路能够确定患者心搏的心率和节律，从而确定心脏是否处在心律失常中。可通过感知的R波和/或P波并将感知的速率与各种参考速率比较，而做出这个确定。
直接感知能够根据各种标准，如，一级心率、骤起和稳定性等，但不限于这些。一个一级心率传感器的唯一的标准是心搏率。在应用这个一级心率标准时，如果心搏率超过一个预定电平，就开始治疗。设定为骤起标准的感知电路忽略缓慢发生的变化，在诸如瞬间阵发性心律失常骤起时开始治疗。这类的标准忽略窦性心动过速。速率的稳定性也能够是一个重要的标准。例如，对于变化的心率过速用室装置的治疗是不准许的，在此，应指示用房装置治疗。
在另一个实施例中，感知可以是间接的。间接感知能够基于各种的功能参数，如动脉的血压、心电图的偏向速率或心电图的概率密度函数(pdf)。例如，通过信号在基准线附近所用的时间的pdf的监视，能够影响是否进行治疗的决定。
通过刺激各房和观察和测量对各房和室的功能的随后的影响能够加强感知。
因此，在一个优选实施例中，感知电路基于多项标准。另外，本发明各预测装置工作在一个以上的腔中，以致，能够对基于上述各种标准的以及业内人士所知的其他标准的感知电路响应，心室或心房给予适当的治疗。刺激
电刺激经由导联线或电极发出。这些导联线能够是心外膜的(心脏外表面)或心内膜的(心脏内表面)，或它们的结合。导联线是业内人士所了解的。例如见本文参引的Heilman等的4662377、Gold等的4481953和Rockland等的4010758美国专利。
导联线系统可以是单极的或两极的。单极导联线具有在导联线本身上的一个电极，阴极。电流从阴极流出，刺激心脏，返回到脉冲发生器的套管上的阳极，完成这个回路。两极导联线具有在导联线上的两个极，在远端彼此相距短的距离，两个电极都在心脏内。
参见图7，此图示出实施本发明的一个系统的例子。一个可植入的自动心律转变器/除颤器2植入在患者的体内，具有一对输出终端，阳极4和阴极6。ICD2耦接到一个柔性的导管电极装置8，后者具有与患者心脏相关的一个远端电极10和一个近端电极12。也可以使用其他的电极配置，如环形的电极。作为外电极可以使用一个阳极24。自动的ICD2包括感知和探测电路，以及脉冲发生电路，后者的输出耦接到可植入的电极10，12。ICD2感知心脏的心动过速的状态，与此相响应，通过可植入的电极10，12，向心脏发出心律转变或除颤脉冲。
导管电极8在静脉内插入的位置，使得远端电极10位于心脏的右室顶14，近端电极12位于心脏的上腔静脉区域16。应理解，本文内使用的术语上腔静脉16也可以包括右心房18的部分。
业内人士了解常规的刺激，后者包括单相波形(阴极或阳极的)，以及多相波形，其中非刺激脉冲是最小幅度的，例如用于放掉电极上的残余的电荷。
图2-6示出两相刺激的方案的一个范围。这些方案公开在本文参引的Mower的美国专利申请08/699,552中。
图2示出两相电刺激，其中第一刺激相包括施加的阳极刺激102，后者具有幅度104和持续时间106。第一刺激相后紧随第二刺激，第二刺激相包括相同强度和持续时间的阴极刺激108。
图3示出两极电刺激，其中第一刺激相包括施加具有幅度204和持续时间206的阴极刺激202。这个第一刺激相是由一个第二刺激相紧随，所述第二刺激相包括相同的强度和持续时间的阳极刺激208。
图4示出两相刺激的一个优选实施例，其中施加的第一刺激相包括，具有幅度304和持续时间306的低电平长持续时间阳极刺激302。这个第一刺激相由包括常规强度和持续时间的阴极刺激308的第二刺激相紧随。在不同的实施方式中，阳极刺激302是1〕为最大的阈下幅度；2〕小于三伏；3〕约2-8毫秒的持续时间；和/或4〕在心脏搏动后施加200毫秒。最大的阈下幅度应理解为，在不引起收缩的情况下的能够施加的最大刺激幅度。在一个优选实施例中，阳极刺激在约三毫秒持续时间中约是二伏。在另外的实施例中，阴极刺激308是1〕短持续时间的；2〕约0.3-1.5毫秒；3〕高幅度的；4〕在三到二十伏的大致范围内；和/或5〕小于0.3毫秒的持续时间和大于二十伏的电压。在一个优选实施例中，阴极刺激约六伏且施加约0.4毫秒。在这些实施方式中，以及在知道了本说明能够明显想到的其他的不同的方式中，在刺激的第一相中取得不激活下的最大的膜电位。
图5示出两相刺激的另一个优选实施例，其中第一刺激相包括阳极刺激402，以上升强度的电平406，施加在时间期间404。上升强度的电平406的倾斜变化的可以是线性的或线性的，斜率能够改变。这个阳极的刺激由第二相紧随，后者包括常规强度和持续时间的阴极刺激408。在另一个实施例中，阳极刺激402是：(1)上升到小于三伏的最大阈下的幅度；(2)持续时间约为二到八毫秒；和/或(3)在心脏搏动后施加200毫秒。在另一个实施例中，阴极刺激408是(1)短持续时间的；(2)约0.3到1.5毫秒；(3)高幅度的；(4)在三到二十伏的大致范围内；和/或(5)持续时间小于0.3毫秒和电压大于二十伏。在这些实施方式中，以及通过本说明能够想到的其他方式中，在刺激的第一相中取得在不激活之下的最大的膜电位。
图6示出两相的电刺激，其中第一刺激相包括阳极脉冲的串列502，以幅度504施加。在一个实施例中，休止时间506是与刺激时间508相同的持续时间的，并且以基线幅度施加。在另一个实施例中，休止时间506是与刺激时间不同持续时间的，并且以基线幅度施加。除了包括常规强度和持续时间的阴极的刺激510的第二刺激紧随在串列502完成的情况，在每个刺激时间508后发生休止时间506。在另一个实施例中：(1)通过阳极刺激的串列502转移的总电荷是在最大的阈下电平；和/或(2)串列502的第一刺激在心脏搏动后施加200毫秒。在另一个实施例中，阴极刺激510是：(1)短持续时间的；(2)约0.3到1.5毫秒；(3)高幅度的；(4)在三到二十伏的大致范围内；和/或(5)持续时间小于0.3毫秒和电压大于二十伏。确定心脏的夺获
能够通过多种方法确定夺获。首先，夺获或夺获的丧失能够通过监视心脏节律确定。夺获的丧失能够造成在心脏搏动定时中的改变。
第二是，通过模板的发展监视夺获。模板能够基于各种参数，如心电图数据，机械运动和/或概率密度函数数据等。若模板是刺激前建立的，在基线中的改变表示夺获。当模板是夺获发生后建立时，模板特性的改变表示夺获丧失。能够建立和/或在任何时间更新模板。
一旦发生夺获，如图1A-1C所示的，调节心律部位的刺激方案被加以调节。
已然说明了本发明的基本原理，业内人士容易明了，上述详细的公开是为了通过例子说明，不是限定本发明。业内人士会设计出各种不同的上面没有陈述的方案，但是这些方案属于本发明的范围。另外，在本说明中提出的起搏脉冲是在带有适当编程的现有的起搏器的电子装置的能力范围内。因此，本发明仅由以下的权利要求和等效替换来限定。

Claims (34)

1.一种可植入的心律转变器-除颤器(ICD)，所述ICD包括：
感知装置，感知心动过速的发作；
输出装置，用于与感知装置相响应而发出预定极性、幅度、波形和持续时间的电刺激，在第一强度上引起两相刺激的施加，所述第一强度是在下述组中选择的：舒张期除极阈，低于舒张期除极阈下和高于舒张期除极阈；和
确定是否已发生夺获的装置；
其中两相刺激包括：
带有第一相极性、第一相幅度、第一相波形和第一相持续时间的第一刺激相；
带有第二相极性、第二相幅度、第二相波形和第二相持续时间的第二刺激相。
2.根据权利要求1的ICD，其特征在于，在确定装置确定未发生夺获时，输出装置以预定的增量增加刺激强度，直到发生夺获。
3.根据权利要求1的ICD，其特征在于，在确定装置确定已发生夺获时，输出装置在预定的时间期间继续两相刺激。
4.根据权利要求1的ICD，其特征在于，在确定装置确定已发生夺获时，输出装置停止两相刺激。
5.根据权利要求的ICD，其特征在于，第一相极性是正的。
6.根据权利要求1的ICD，其特征在于，第一相幅度小于第二相幅度。
7.根据权利要求1的ICD，其特征在于，第一相幅度是从基线值到第二值倾斜变化的。
8.根据权利要求7的ICD，其特征在于，第二值等于第二相的幅度。
9.根据权利要求7的ICD，其特征在于，第二值是最大的阈下幅度。
10.根据权利要求9的ICD，其特征在于，最大的阈下幅度约为0.5-3.5伏。
11.根据权利要求7的ICD，其特征在于，第一相持续时间至少是与第二相持续时间相同。
12.根据权利要求7的ICD，其特征在于，第一相持续时间约为一到九毫秒。
13.根据权利要求7的ICD，其特征在于，第二相持续时间约为0.2到0.9毫秒。
14.根据权利要求7的ICD，其特征在于，第二相幅度约为二到二十伏。
15.根据权利要求7的ICD，其特征在于，第二相持续时间小于0.3毫秒，并且第二相幅度大于20伏。
16.根据权利要求1的ICD，其特征在于，第一刺激相还包括预定幅度，极性和持续时间的刺激脉冲的一个串列。
17.根据权利要求16的ICD，其特征在于，第一刺激相还包括休止期的一个串列。
18.根据权利要求17的ICD，其特征在于，施加第一刺激相还包括在至少一个刺激脉冲后施加基线幅度的一个休止期。
19.根据权利要求18的ICD，其特征在于，休止期与刺激脉冲的持续时间相同。
20.根据权利要求1的ICD，其特征在于，第一相幅度是最大的阈下幅度。
21.根据权利要求20的ICD，其特征在于，最大阈下幅度约为0.5-3.5伏。
22.根据权利要求1的ICD，其特征在于，第一相持续时间至少与第二相持续时间相同。
23.根据权利要求1的ICD，其特征在于，第一相持续时间约为一到九毫秒。
24.根据权利要求1的ICD，其特征在于，第二相持续时间约为0.2到0.9毫秒。
25.根据权利要求1的ICD，其特征在于，第二相幅度约为二到二十伏。
26.根据权利要求1的ICD，其特征在于，第二相的持续时间小于0.3毫秒，并且第二相幅度大于20伏。
27.根据权利要求1的ICD，其特征在于，第一刺激相在一个心脏的搏动的循环完成后大于200毫秒的时间开始。
28.一种操作可植入的心律转变器-除颤器(ICD)的方法，所述的ICD具有发出预定极性，幅度，波形和持续时间的输出装置，所述方法包括步骤：
感知心律过速的开始；
在第一强度施加从由两相刺激和常规刺激构成的组中选择的刺激，所述第一强度是从舒张除极阈，低于舒张除极阈或高于舒张除极阈的组中选择的；
确定是否发生夺获；
以预定的增量增加刺激强度，直到发生夺获；和在夺获时
在低于舒张除极阈的第二强度，继续进行从两相刺激和常规刺激的构成组中选择的刺激。
29.一种操作可植入的心律转变器-除颤器(ICD)的方法，ICD具有输出装置发出预定极性、幅度、波形和持续时间的电刺激，所述方法包括步骤：
限定带有正极性、第一相幅度、第一相波形和第一相持续时间的第一刺激相，其中所述第一相幅度约为0.5-3.5伏，所述第一相持续时间约为一到九毫秒，所述第一刺激相在一个心脏搏动循环完成后多于200毫秒的时间开始；
限定带有负极性、第二相幅度、第二相波形第二相持续时间的第二相，其中所述第二相幅度约为四伏到二十伏，第二相持续时间约为0.2到0.9毫秒；和
感知心动过速的开始；
向心脏组织顺序施加第一刺激相和第二刺激相；
确定是否夺获；和
以预定增量增加刺激强度，直到发生夺获。
30.一种操作可植入的心律转变器-除颤器(ICD)的方法，ICD具有发出预定极性，幅度波形和持续时间的电刺激的输出装置，所述方法包括步骤：
感知心动过速的开始；
在第一强度施加两相刺激，所述第一强度选择自舒张除极阈，低于舒张除极阈和高于舒张除极阈的构成组，两相刺激包括：
带有第一相极性、第一相幅度、第一相波形和第一相持续时间的第一刺激相；和
带有第二相极性、第二相幅度、第二相波形和第二相持续时间的第二刺激相；和
确定是否夺获。
31.一种可植入的心脏刺激器装置包括：
多个电极；
感知电路，连接到多个电极而能够感知心动过速的开始；
探测电路，连接感知电路而能够探测是否发生夺获；和
脉冲发生电路，连接到多个电极，与感知电路相响应，能够发生预定极性、幅度、波形和持续时间的电脉冲，引起在第一强度上施加两相刺激，所述第一强度选择自舒张除极阈、低于舒张除极阈、和高于舒张除极阈构成的组；和
其中两相刺激包括：
带有第一相极性、第一相幅度、第一相波形和第一相持续时间的第一刺激相；和
带有第二相极性、第二相幅度、第二相波形和第二相持续时间的第二刺激相。
32.根据权利要求31的可植入的心脏刺激器装置，其特征在于，在探测电路确定未发生夺获时，脉冲发生电路以预定增量，增加刺激强度，直到发生夺获。
33.根据权利要求31的可植入心脏刺激器，其特征在于，在探测电路确定发生夺获时，脉冲发生电路在预定时间期间继续两相刺激。
34.根据权利要求31的可植入的心脏刺激器，其特征在于，在探测电路感知发生夺获时，脉冲发生电路停止两相刺激。
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CN103180011B (zh) * 2010-10-21 2015-11-25 美敦力公司 用于选择起搏向量的夺获阈值测量
CN104797292A (zh) * 2012-11-15 2015-07-22 美敦力公司 用于选择起搏向量的夺获阈值测量
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