CN1878595A - 带有无线功率供给的静脉内心脏起搏系统 - Google Patents

带有无线功率供给的静脉内心脏起搏系统 Download PDF

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CN1878595A
CN1878595A CNA2004800329225A CN200480032922A CN1878595A CN 1878595 A CN1878595 A CN 1878595A CN A2004800329225 A CNA2004800329225 A CN A2004800329225A CN 200480032922 A CN200480032922 A CN 200480032922A CN 1878595 A CN1878595 A CN 1878595A
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electrode
pulse
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CN1878595B (zh
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S·登克尔
A·J·博伊特勒
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Kenergy Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/37512Pacemakers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37211Means for communicating with stimulators
    • A61N1/37252Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37258Alerting the patient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/378Electrical supply
    • A61N1/3787Electrical supply from an external energy source

Abstract

一种心脏起搏器包括周期性地发射射频信号脉冲给植入动物静脉或动脉内血管电极-支架的功率发射机。该血管电极-支架使用来自该射频信号的能量来充电一作为功率供给的存储设备。该血管电极-支架还检测心脏窦房结发放的心电信号并通过将来自存储设备的电压脉冲施加给植入在动物血管系统内的电极对来对其做出响应。对电极应用电压脉冲刺激心脏的收缩。

Description

带有无线功率供给的静脉内心脏起搏系统
技术领域
本发明涉及发放能量给心脏组织以刺激心脏收缩的植入式医疗设备,尤其涉及可植入静脉或动脉内的心脏起搏设备。
背景技术
对于自然心搏缓慢或停顿的治疗方法是植入带有微小电子装置刺激心脏以一定速率搏动的心脏起搏设备。
起搏设备通常被植入病人的胸腔内,并且具有检测与心脏收缩相关联电脉冲的传感器电极。分析这些感知脉冲以确定不规律心脏活动何时出现以及在何种情况下触发脉冲发生器以产生电脉冲。当电刺激收缩心腔时,导线将这些脉冲送给邻近特定心肌放置的插入型(patch-type)刺激电极。恰当放置刺激电极以产生心腔收缩是很重要的。
现代的心脏起搏设备改变刺激以适应病人不同活动水平下的心率,从而模仿心脏的自然活动。脉冲发生器通过跟踪心脏窦房结的活动或通过响应指示身体移动或呼吸率的其他传感器信号来修改该心率。
美国专利No.6,445,953描述了一种具有放置在病人体外以检测不规律或较弱心脏活动的起搏设备的心脏起搏器。在那种情况下,该起搏设备发射可由安装在植入在病人心脏静脉或动脉内血管支架(stent)上的电路接收的射频信号。更具体地,该射频信号感应血管支架上天线内的电压脉冲,并通过血管支架上的一对电极施加该脉冲以刺激邻近的心肌并收缩心脏。虽然该心脏起搏装置提供了优于其他类型心脏起搏器的若干好处,但是它需要替换病人胸腔内的感应电极,从而在心脏需要刺激时可由外部起搏设备用于检测。
发明内容
提供一种能够人工刺激动物心脏收缩的心脏起搏装置。该装置包括功率发射机,它将射频信号脉冲周期性地发给适当植入在动物静脉或动脉内的血管电极-支架。
血管电极-支架包括诸如线圈导线的拾取设备,用于接收射频信号以及来自心脏窦房结的心电信号。起搏信号电路连接拾取设备以及与动物组织相接触的一对电极。起搏信号电路具有由来自射频信号电能充电的电存储设备。响应于检测的心电信号,起搏信号电路将刺激电压脉冲应用于该电极对以引发心脏的收缩。
在血管电极-支架的一个较佳实施例中,起搏信号电路包括鉴别器和脉冲电路。鉴别器连接至拾取设备并响应于检测的射频信号脉冲来控制对电存储设备的充电。当鉴别器检测到心电信号时就生成一触发信号,从而使得脉冲电路将刺激电压脉冲应用于该电极对。
附图说明
图1是附在病人身上的心脏起搏装置的表示;
图2是该心脏起搏装置的功率发射机的电路图;
图3是植入了血管电极-支架和第二电极的心脏血管的等比例剖视图;
图4是图2所示血管电极-支架上电路的框图;以及
图5A、B和C是心脏起搏装置中三个电信号的波形图。
具体实施方式
首先参考图1,电刺激心脏12以使其收缩的起搏装置10包括功率发射机14和血管电极-支架20。功率发射机14最好佩戴在病人体外并邻近胸腔,同时还发射可由血管电极-支架20接收的射频信号16。另外,也可将功率发射机14植入病人体内。随后将详述,对射频信号16的接收为电极-支架上的电路提供了电功率。血管电极-支架20位于运送血液通过心脏并最邻近窦房结的动脉或静脉18内。例如,血管电极-支架20可以位于____动脉内。
参见图2,功率发射机14包括连接至定时电路24和天线26的射频(RF)发射机22。RF发射机22和定时电路24都由电池28供电。定时电路24控制RF发射机22以发射周期性的射频信号脉冲16。例如,这些脉冲可以如图4A所示具有相对缓慢的上升和下降沿,使得信号电平能够逐渐地上升和下降。
如图3所示,电极-支架20包括一主体30,它类似于已知的用于扩张受限静脉或动脉的可扩张血管支架。该血管支架具有大致呈管状的形状,并起初收缩成相对较小的直径以使其能够自由通过病人的血管。电极-支架20的植入过程类似于传统的血管支架。例如,可将标准导管一端的气球插入具有收缩结构的血管电极-支架20中。这一装配是通过在接近病人皮肤的静脉或动脉上切口并将其推送经过血管系统以到达最接近心脏12窦房结的合适位置而得以插入的。导管上的气球随后就膨胀以扩张血管电极-支架20,从而略微扩张将该电极-支架嵌入静脉或动脉壁的血管18。随后该气球放气,将导管从病人体内移出并缝合切口。另外还将自扩张血管支架用作主体30。略微扩张的血管18和血管支架主体30的管状设计使得血液能够相对无阻碍地流过血管电极-支架20。
参考图3和图4,血管电极-支架20具有起搏信号电路32和以线卷形式环绕主体30的拾取设备34。环形的第一电极36围绕主体。起搏信号电路32包括连接至拾取设备34的脉冲鉴别器38。如下将详述,脉冲鉴别器38区分在拾取设备中感应出的电脉冲是由心脏窦房结的电激动引起的还是由功率发射机14的RF信号16引起的。这一区分的做出是基于各自的信号波形以及如图4A所示的RF信号16和如图4B所示的来自窦房结的心电信号。RF信号具有相对较长的脉宽以及渐变的上升沿和下降沿。相反地,心电信号电脉冲的脉宽很短并且上升和下降都很迅速。脉冲鉴别器38还可以同时检测这两种类型的脉冲。
只要检测到RF信号脉冲,脉冲鉴别器38就使用该信号的能量来为存储电容器40充电,该电容器40为血管电极-支架20上的电路提供电功率。也可使用其他类型的电存储设备。射频信号为血管电极-支架提供能量,并与先前不触发心电刺激的无线起搏器相异。
心脏12窦房结发出引发心腔收缩的心电信号。心电信号逐细胞地沿着心脏路径传播至心肌以收缩心房。该信号还可沿着另一条路径传播直到房室(AV)结,其中房室结是位于心房和心室之间的心脏中央的一簇细胞。房室结可以起到在允许心电信号送至心室之前减速电流的出入口的作用。该延迟确保了心室收缩之前心房具有完全收缩的机会。
因为接近窦房结的血管电极-支架20的放置,所以心电信号的发放也能在如图4B所示在拾取设备或血管电极-支架20的线圈34内感应出电流脉冲。脉冲鉴别器38将该脉冲快速上升时间与图4A所示的RF信号脉冲作比较,从而认定其为心电信号。当检测到心电信号时,脉冲鉴别器38发送触发信号给脉冲电路42。脉冲电路42类似于在先前的心脏起搏设备中使用并用于生成如图5C所示电压脉冲以刺激心脏收缩的电路。更具体地,一旦被触发,则脉冲电路42就使用电容器40上的电荷来产生电压脉冲,并将该电压脉冲应用于延伸围绕该血管支架主体的第一电极36和远离血管电极-支架20的第二电极44之间。
如图3所示,第二电极44可靠地位于心脏另一部分内的血管壁46,并由延伸通过该血管的绝缘细导线48连接至脉冲电路42。第二电极44相对较小的体积使其能够被放入明显小于血管电极-支架20的血管46中。结果是,大大提高了在心血管系统内放置第二电极44的位置可变性,并且放置使其最接近心脏12期望收缩部分的心肌。
根据放置的第二电极44是刺激心房还是心室收缩,脉冲电路42在接收到来自脉冲鉴别器38的触发信号之后并在给第一和第二电极施加电压脉冲之前延迟一定的时间量。因此,心肌刺激的定时对应于参考自然引发的心房或心室收缩的出现。延迟的持续时间由外科医生在植入时程控入脉冲电路42,并且是第二电极位置的函数。
在其他形式的血管电极-支架20中,可以在其他的血管52中植入诸如第三电极50的一个或多个附加电极以刺激心脏的更多部分。在此情况下,可在第一电极36以及每个附加电极44和50之间施加独立的电压脉冲以分别刺激心脏的那些其他部分的收缩。也可在第二和第三电极44和50间施加刺激脉冲而无需使用第一电极36。
前面的描述主要涉及本发明的较佳实施例。即使可对本发明范围内各种修改给予一定的关注,但是应该预料到本领域普通技术人员将很容易认识到从本发明实施例的公开中这些额外的修改是显而易见的。因此,本发明应当由所附权利要求确定并且不受上述公开所限。

Claims (19)

1.一种用于人工刺激动物心脏收缩的心脏起搏装置,包括:
周期性地发射射频信号脉冲的功率发射机;
用于植入动物体内的第一电极和第二电极;以及
植入所述动物血管内的血管电极-支架,所述血管电极-支架包括用于接收射频信号以及从心脏窦房结发送的心电信号的拾取设备,连接所述拾取设备并具有电存储设备的起搏信号电路,其中所述起搏信号电路使用来自所述射频信号的电能充电该电存储设备并响应于检测的心电信号将刺激电压脉冲应用于所述第一电极和第二电极以引发心脏的收缩。
2.如权利要求1所述的装置,其特征在于,所述第一电极是安装在所述血管电极-支架上。
3.如权利要求1所述的装置,其特征在于,所述电学存储设备是电容器。
4.如权利要求1所述的装置,其特征在于,所述拾取设备包括一线圈。
5.如权利要求1所述的装置,其特征在于,所述起搏信号电路包括:
连接至拾取设备的鉴别器,它响应于检测的射频信号脉冲来充电所述电存储设备,并响应于检测到的心电信号生成一触发信号;以及
连接至所述鉴别器和所述电存储设备的脉冲电路,它响应于所述触发信号对所述第一电极和第二电极施加刺激电压脉冲。
6.如权利要求5所述的装置,其特征在于,所述鉴别器基于其信号波形的差异来区分来自功率发射机的射频信号和来自窦房结的心电信号。
7.如权利要求6所述的装置,其特征在于,来自所述功率发射机的射频信号的每个脉冲都比来自窦房结的心电信号具有更长的上升沿持续时间。
8.如权利要求1所述的装置,其特征在于,来自所述功率发射机的射频信号的脉冲和来自窦房结的所述心电信号脉冲是异步的。
9.如权利要求1所述的装置,其特征在于,还包括在动物体内植入并连接至所述血管电极-支架的第三电极,其中所述起搏信号电路将电压脉冲施加给所述第三电极。
10.一种用于人工刺激动物心脏收缩的心脏起搏装置,包括:
周期性地发射射频信号脉冲的功率发射机;
用于植入所述动物血管内的血管电极-支架,所述血管电极-支架包括一主体,位于该主体上的起搏信号电路,用于接收射频信号以及从心脏窦房结发送的心电信号的拾取线圈以及安装在所述主体上的第一电极;以及
用于植入动物血管内的第二电极;
所述起搏信号电路包括电存储设备,连接至所述拾取线圈并响应于检测到所述射频信号的脉冲而充电该电存储设备同时响应于检测到心电信号生成一触发信号的鉴别器,以及连接至所述鉴别器和所述电存储装置并将刺激电压脉冲应用于所述第一电极和第二电极以引发心脏收缩的脉冲电路。
11.如权利要求10所述的装置,其特征在于,所述主体在所述血管内可从第一剖面尺寸扩张至第二剖面尺寸。
12.如权利要求10所述的装置,其特征在于,所述第一电极是围绕着所述血管电极-支架主体的导电环。
13.如权利要求10所述的装置,其特征在于,所述电存储设备是电容器。
14.如权利要求10所述的装置,其特征在于,所述鉴别器基于其信号波形的差异来区分来自功率发射机的射频信号和来自窦房结的心电信号。
15.如权利要求14所述的装置,其特征在于,来自所述功率发射机的射频信号的每个脉冲都比窦房结发放的心电信号具有更长的上升沿持续时间。
16.如权利要求10所述的装置,其特征在于,来自所述功率发射机的射频信号的脉冲和窦房结发放的所述心电信号脉冲是异步的。
17.如权利要求10所述的装置,其特征在于,还包括在动物血管内植入并连接至所述起搏信号电路的第三电极,其中所述脉冲电路将电压脉冲施加给所述第一和第三电极之间。
18.如权利要求10所述的装置,其特征在于,还包括用于在动物血管内植入并连接至所述血管电极-支架的第三电极,其中所述起搏信号电路将电压脉冲施加给所述第二和第三电极之间。
19.一种刺激动物心脏收缩的方法,所述方法包括:
在该动物的血管第一位置上植入一血管电极-支架,该血管电极-支架具有拾取设备和第一电极,它们同时连接至具有一电存储设备的起搏信号电路;
在该动物的血管第二位置上植入一第二电极,其中所述第二电极连接至所述血管电极-支架的起搏信号电路;
发送一射频信号至所述血管电极-支架;
使用来自所述射频信号由所述起搏信号电路接收的电能来充电所述电存储设备;
所述起搏信号电路检测来自心脏窦房结的心电信号的发射;以及
所述起搏信号电路通过将来自所述电存储设备的电压施加给所述第一和第二电极来响应检测到的所述心电信号发送,以刺激心脏的收缩。
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