CN1476339A - 采用传感活动通过对胃肠道的电刺激来治疗肥胖症的方法及仪器 - Google Patents
采用传感活动通过对胃肠道的电刺激来治疗肥胖症的方法及仪器 Download PDFInfo
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Abstract
一个带有传感器的胃刺激系统及通过可植入的胃刺激器(单腔室/可转换电极IGS)对患者进行胃刺激的方法,包括信息处理器(“微处理器”),电刺激电路(“刺激电路”),遥感电路(“遥感收发器”)。此可植入刺激器检测胃电活动(慢波和/或蠕动波)并发送电刺激以有意地破坏或扰乱程序设定的部分正常胃电活动。刺激由正常胃电活动触发,并且可以产生相对于预期的胃电传播方向的空间位移,或相对于预期的下一个传播波或蠕动波的时间延迟。编程部件(图中未显示-通过无线电频率数据通道)可以非介入地设定刺激参量和间隔。刺激器可在一个或多个刺激点实施刺激,还可整合一个或多个彼此独立的可由程序控制的传感和刺激通道(见“电刺激电路”和“输出/输入电极”)。可植入胃刺激器的信息处理器利用来自非电极传感器的信息,确定对患者胃壁应用电刺激信号的极化率周期或窗口。
Description
发明背景
1.发明领域
本发明涉及可植入式的胃电刺激系统,可用于降低胃动力以及(或者)胃效率,从而用于肥胖症的治疗。特别是,本系统含有一个可植入的电刺激器,一个或多个可植入的刺激导线(电极),一个外置的编程部件,以及用于自动控制同步的电刺激频率、时间间隔、幅度、或这些参量的组合的算法,可用于治疗肥胖症及其它消化道功能紊乱症。
2.相关背景描述
肥胖症是西方国家的一个主要健康问题。调查表明33%的人口超重,而且人数逐年增长。肥胖症是美国可预防性死亡的第二大病因。它与几乎影响每个人体系统的几个因素有关。例如:高血压、糖尿病、冠心病、呼吸系统功能紊乱、以及肌肉与骨骼问题。据估计,每年与肥胖症相关的花费接近700亿美元。
有许多因素会引起肥胖,但缺乏运动和过量饮食是两个主要因素。目前的治疗方法包括节食、锻炼、抑制食欲药物、增强新陈代谢药物、胃肠道约束手术、以及胃肠道的手术修正。这些疗法的效用可能很低或者毫无效用,也可能可以减轻初始体重的50%。
胃麻痹是相反的病理情况,此时胃功能受损。胃麻痹病人表现为胃动力不足,并有恶心、呕吐及胃部不适等并发症状。病人可能有胃涨或过早感到饱的感觉。通常,这会造成食物摄入减少(量、频率),继而体重减轻。从生理上讲,此症状可能与胃损伤或胃部神经系统损伤或者胃平滑肌营养不良从而造成的胃平滑肌蠕动减弱(幅度、频率)有关。一些研究指出此症状还与胃功能紊乱有关。
如果能够适当的控制和调节,对胃麻痹的症候学及其引发的症状的研究可能揭示了一些有助于对肥胖症治疗的因素。这就提出了一类可植入的电子设备,可以通过诱发正常胃动力的电生理紊乱从而产生轻微的、可逆的胃麻痹。
胃是消化道(食物通道)的一个复杂的器官,具有分解、消化及移动食物的基本功能。这些典型的功能伴随着促进分解的生化反应物的分泌、减少食物颗粒大小从而促进混合的各种运动、以及将食糜(小食物颗粒和生化反应物的溶液)送入肠道的运动。胃的这些运动是由胃壁平滑肌的有规律的收缩完成的。
胃的正常收缩由三个部分控制:神经活动,化学活动,肌原活动。
神经控制部分是指促使胃部运动的内外神经。内神经释放不同的神经传递素及缩氨酸,控制胃的收缩和自主运动。研究表明外神经会通过释放调节物质从而影响胃的收缩。
化学控制部分是指神经末梢或内分泌细胞和胃部腺体释放的不同物质(神经传递素、神经调节素及缩氨酸)。这些化学物质可直接作用于平滑肌细胞或神经以调节或控制胃收缩和自主运动的发生。
肌原控制部分是指由于平滑肌极化及去极所造成的小的电位波动。肌肉活动被称为电控制活动或慢波。
慢波是蠕动活动潜在的记时器。慢波一直存在,大约每分钟2到4次。慢波并不都与收缩相关联,但是正常的蠕动收缩的发生一定与慢波同步。
要产生正常的蠕动收缩,必须存在多种控制方法。慢波(由细胞膜电位去极化产生)提供了基本的定时/间隔及组织。但是典型的慢波去极化本身的强度不足以达到使平滑肌收缩所需要的阈值。必须有神经或化学的部分存在以增强肌原活动。在神经和/或化学部分存在的情况下,去极化的强度超过了肌肉兴奋所需的阈值,从而产生收缩。(收缩由称为电反应活动或动作电位的附加的电活动所引起。)
但是,产生收缩只是蠕动活动的一部分。要在生理上有效(有效地减小、混合并/或推动胃里的食物),收缩必须在空间上和时间上(垂直和/或平行于胃部不同的肌肉层)有组织地,分阶段地传播。
通常,收缩包括胃壁周向及纵向肌肉层的收缩。周向肌肉层的收缩减少了胃室的直径。纵向肌肉层的收缩减少胃的长度,并且可能有助于与收缩的周向肌肉层毗连的腔室的扩张并把收缩传播到附近的没有收缩的周向肌肉层段。两种肌肉层的协调收缩是蠕动传播所必不可少的。
对这三个控制部分和/或收缩传播协调性的有意识的干预可能损害收缩功能及相关的运动功能。从电生理学的角度,这种干预可以通过以下一种或几种方法控制:
(a)用电刺激在慢波或蠕动波之前(空间上或时间上)或同时产生个别细胞或细胞群不同步的去极化,造成波的无组织或减弱;
(b)用电刺激在慢波或蠕动波之前产生大量细胞同步的去极化,形成一个波的不应区;
(c)对胃部神经持续的电刺激,造成刺激区域的神经脱敏,抑制或阻碍;
(d)用电刺激产生频率大于4cpm的慢波,形成胃动过速的状态,从而不会产生蠕动;
(e)用电刺激产生一个与固有频率相近但位置不同的慢波,形成抵消性的异位波;以及
(f)通过对个别肌层的时间或空间隔离的,定向的电刺激造成蠕动协调性的解耦。
其他一些方法也能达到相同的效果,但可能不便于应用,需要反复应用或多种操作,并且可能是不可逆的。这些方法包括:
(a)通过离格技术(辐射频率、微波、低温技术)造成平滑肌损伤,从而降低平滑肌的收缩能力,或将收缩矢量改变到一个不太有效的方向或次序;并且
(b)通过精确控制肌肉内麻痹药物(如,波特淋菌毒素,箭毒,等等)的剂量和模式使作用区域无法产生收缩并且/或者使收缩沿无效路径进行。
上述方法在另外的著述中有探讨。这些著述集中探讨损伤的电生理机制。
对胃及胃肠道的其它部分的电刺激的实验已经进行了一段时间。大部分实验意图通过加速或加强/恢复蠕动活动以提高胃排空能力。
1995年6月3日授予Cigaina的,U.S.专利5423872的“治疗肥胖症及胃运动功能紊乱综合症患者的方法及设备”,介绍了一种在胃窦区域植入的电刺激器,此区域节律性产生对整个胃部进行刺激的电脉冲,从而人为的改变胃部的自然活动以阻止排空或减慢食物通过胃的速度。Cigaina的不足之处在于它仅仅是一个刺激装置,与能通过磁效应手动操纵装置相比,缺少按需提供刺激的能力,因而由于在不需要的时候提供刺激能量的浪费。
1997年11月25日授予Chen等人的,U.S.专利5690691的“有相多点胃肠道起搏器”,介绍了一种便携式或可植入的胃起搏器,它在胃部大屈曲处置入一些电极,在不同位置产生不同相位的电刺激以加速或减缓胃肠道的蠕动。Chen等人还提供了一个传感电极或刺激电极,通过它感知一个器官对电刺激的反应,从而使其它一组电极产生有相的电刺激。但是,Chen等人专注于沿蠕动传播路径布置的一组电极中传播的有相刺激并感知器官对这些刺激的反应。Chen没有提到为达到治疗的目的而需要的对内部电活动的感知。
1998年11月17日授予Bourgeois的,U.S.专利5836994的“胃肠道电刺激的方法与仪器”,介绍了一种可植入的胃刺激器,它可通过一个或多个预先设定好频带的传感器感知胃内的电活动,并据此应用或中止刺激。Bourgeois的传感电路在探测到蠕动波时停止治疗,探测不到则施加刺激。它没有采用损伤胃部活动的疗法。
2000年7月18日授予Bourgeois的,U.S.专利6091992的“胃肠道电刺激的方法与仪器”,与上面的994专利相似。它提供了具有不同参量的独立的电脉冲序列,此序列包含有一系列(至少两种)脉冲。此疗法用于促进胃蠕动。
2000年8月15日授予Bourgeois的,U.S.专利6104955的“胃肠道电刺激的方法与仪器”,涉及一种电刺激器,可以回复到探测状态以确定体内慢波间隙,从而在胃部处于内消化状态时防止刺激。如Bourgeois前面的专利一样,’955的刺激用于增加胃动力。
1999年1说19日授予Famoloni的,U.S.专利5861014的“按需探测胃肠道刺激的方法与仪器”,是关于一种可植入的胃刺激器,可感知胃肠道非正常的电活动,从而在非正常电活动之前或过程中提供电刺激以治疗胃活动失常。Familoni还提供了非正常电活动的前期记录,但没有提到改变正常的胃活动以达到诸如治疗肥胖等不同效果。他没有将疗法应用于扰乱正常的胃活动。
因此,此前的工作都是关于(1)提供电刺激(有相或无相)而不考虑体内活动,或(2)提供电刺激以引起正常蠕动,或(3)提供电刺激与正常胃活动相互作用。
如上所述,此前的工作没有提出根据内部胃电活动提供电刺激以干扰正常的胃电活动的想法。
发明概述
本发明主要是应用可植入的胃刺激和导线系统检测体内胃电活动,判断此活动正常与否,并对正常活动应用电刺激以达到破坏/扰乱它的目的。
简单概括一下,本发明是关于一个胃刺激系统(IGS)和对使用可植入式胃刺激器的患者进行胃刺激的方法,包括一个信息处理器,电刺激电路,电传感电路,电极转换电路,以及遥感勘测电路。还提供了一个远端程序用于与植入式胃刺激器的遥感勘测电路一起工作,控制配备有信息处理器的电刺激电路的工作。植入式胃刺激器和患者的胃壁之间用导线作为刺激和/或传感电极。刺激电极用于把电刺激电路发出的电信号传导到患者的胃壁,而传感电极则通过传感电路把体内胃电活动信息传达给信息处理器。电极转换电路使得每个电极的功能和极性能够被信息处理器所控制。
附图说明
图1为IGS系统的组成;
图2A和2B进一步图示了刺激导线及其结构;
图3为电极在胃内的放置;
图4为一个单通道IGS的功能方框图;
图5为多通道的功能方框图;
图6为一个三电极系统可能的电极传感“对”和刺激向量;
图7为一个四电极系统可能的电极传感“对”和刺激向量;
图8为一个正常的胃慢波沿胃的行进;
图9描述了慢波可辨别的特性;
图10为正常和不正常胃活动的辨认/分类;
图11为多点电刺激;
图12为穿过一个慢波的电刺激;
图13为有空间移位的电刺激;
图14为有空间和时间移位的电刺激;
图15为预先电刺激;
图16展示了用于计算预期的下一个慢波间隔的传感历史记录;
图17为预刺激的时序;
图18表示在E处施加的解耦刺激(由C处的传感所诱发)。解耦刺激的目的是开始一个反收缩。
图19表示一个成比例的刺激,用于扰乱25%的正常慢波;而
图20表示一个成比例的刺激,用于扰乱50%的正常慢波。另一个实施例可以破坏后面的每一个正常慢波。
较佳实施例的详细描述
本发明的较佳实施例包含一个可植入的胃刺激器(IGS),一个或多个在胃壁和IGS间形成电耦的可植入导线(二或多个电极),一个可通过无线电频率数据通道与IGS进行非介入的信息传递(双向)的编程部件(见图1)。
外部程序部件是医师(使用者)和IGS之间的接口。它包括一个用于与IGS通信的收发器,一个使医师能够进行输入/输出操作的界面(例如,键盘,触觉按钮或软按钮,显示器,软件),以及将输入和输出转化为两端(设备及使用者)各自适合的格式的电路及程序。程序部件通过一个无线频率数据通道将信息传达到设备或者接收设备的信息。信息以数据包流的形势传送。本装置中,通过一个查错算法以确定数据包流的正确性。
可植入导线包含一个与IGS连接的连接头端(近端),一个连通连接头端和电极的导线体(中间部分),以及与胃壁接触的电极端(远端)。(参见图2A)。
连接头端包括一个或多个近端的电路终端,一套使终端之间及终端和周围环境之间绝缘的装置,以及一套把连接头固定于IGS的机械装置。
导线体(中间部分)包含电极之间以及近端电路终端之间的连续通路。通常,这条通路是一个拉长的金属线圈。导线体可以有一个或多个线圈。线圈通过绝缘鞘彼此绝缘并与周围环境绝缘。图2B显示了一个典型的导线体的结构。典型地,每个线圈连接到一个特定的近端(相应于一个IGS输入/输出)及一个特定电极。一个可调配置则可能有多个电极连接于同一个线圈。
导线的电极端(远端)与胃壁进行电信号的交流。在本装置中,电极成对使用以产生双极的探测或刺激。不过,同样在此装置中,在同样的可植入导线中并不要求这样的双极对(采用多个单极导线或是单极和多级导线的组合)。电极应与胃平滑肌的电路层交换信息。这种交换可以通过与绒膜表面接触、将电极嵌入肌肉(纵向或周向肌肉内)、或绒膜下放置进行。图3所示为电极嵌入周向肌肉层。电极的大小和形状必须考虑到功能,植入位置及所要用到的刺激参量。传感电极应有最大的表面积以得到内部电信号。刺激电极必须有最小表面积以集中刺激的能量密度,但也要考虑到由于刺激脉冲和离子不平衡引起的金属分裂。同样地,胃壁厚度变化范围(由位置决定)从4-5mm到大于1cm,周向层和径向层的厚度约为其一半。进一步,远端包含将电极牢固附着于胃壁的装置。本装置的固定机制是一对聚合体叉,位于电极两端,方向相对。图2显示了在导线远端的叉的外形。还有一个可选的固定方法是用缝线穿过组织并绕过导线体的人造橡胶包皮把导线固着于胃壁。
IGS是一个小的复合型脉动发生器。从外部看,它有一个密封机架和一套将导线与内部电子装置连接的电子和机械装置。从内部看,IGS包含有电子线路及能源供应(电池和/或高频能量耦合电路)。
在本较佳实施例中,电子线路包括一个微处理器、电子传感(输入)电路、电子刺激(输出)电路、电极转换电路、遥感电路、以及随机存取存贮器(参见图4)。在可选装置中,IGS可以配有多道传感和/或刺激电路(通道),因而可以对胃部不同区域提供更好的探测和刺激(参见图5)。
微处理器是一块用作信息处理器的集成电路,用来控制IGS的功能、性能、和分析(如果有的话)。它接收来自遥感电路、传感电路、RAM、以及内部功能性检查的输入。依靠编制的程序以及这些输入,微处理器控制遥感电路、刺激电路、RAM、以及电极转换电路的输出。处理器控制输入和输出队列及参量的定时及路由。
传感电路通过导线中所选择的电极接收体内胃电活动的信号。探测到的信号输入用来对体内胃活动分类并以此作为刺激输出的触发器。传感电路对内部信号进行滤波和放大后传送到微处理器。传感电路可以应用神经网络算法帮助对体内胃活动的分类。传感电极、传感的定时、以及放大幅度由微处理器控制并且是可编程的(通过遥感电路)。
刺激电路提供刺激所需用的电脉冲。刺激电路可产生恒定电流或恒定电压。在所介绍的装置中,刺激电路所提供的脉冲可以通过编程改变幅度、频率(每秒脉冲数)、及脉冲宽度。一个可选设备中,通过在使用一组形成阵列(switchcap技术)的电容中切换的办法提供毗连或重叠的窄脉冲从而得到一个连续(或接近连续)的宽脉冲。刺激电路由微处理器控制并且可编程。
电极转换电路确定了每个电极的功能及其极性。在所介绍的装置中,电极转换电路可使一对电极用于传感,而一对或多对电极用于刺激。图5和图6显示了对三电极或四电极系统可能的传感配置(“对”)和可能的刺激向量。刺激和传感可以使用同一组电极。在刺激周期,电极转换电路可以改变刺激电极的极性,以产生多相脉冲,在脉冲之间或一系列脉冲之间以及不同的刺激向量之间改变极性。同样地,转换电路可以使不同的传感电极对在不同的位置或沿不同的向量对胃电活动进行采样。可以采用综合的传感模式来区分慢波传播方向和间隔。转换电路还可以包含补偿(以抵消传感过程中穿过开关泄漏的内部电流)及消隐功能以防止传感放大器达到饱和。转换电路由微处理器控制并且是可编程的。复杂的转换机制可以存储于RAM中并作为一个程序被激活。转换软件应保证每种配置都至少有一个双极对以完成整个电子线路。
遥感电路包括一根天线和一个接收器。此电路还可能带有一个缓存以容纳大量的数据交换。遥感电路传送并接收送往或来自编程部件的脉冲。脉冲可能在无线频率使用调幅、调频、或脉冲调制。本装置中,遥感范围可达几英寸以确保IGS能够植入得较深。遥感信号流使用启动协议建立双向信号传输,一个身份包以提供设备/程序辨认,多个信息或程序包以传输所需的数据,数据包的查错机制(循环冗余查错或校验和)以确保信息的准确性,以及一个结束协议以标志信号流的结束。输入流由微处理器处理以设定IGS参量。输出流主要用于确认输入流已得到接收,确认IGS设定或者提供由外部编程部件处理的原始数据/信息。
RAM用于存储IGS所需的信息及程序。RAM接收来自微处理器的关于内部胃电活动的传感信息,根据选定的算法分析信息以确定活动是否正常,并将分析结果送至微处理器以根据所选择的特定程序开始治疗。RAM中可存储多组程序以建立IGS激活、反应及性能的特定程序表。RAM还可以存储不同的参量,表明设备性能、胃活动、及进行的治疗。
使用时,本发明的较佳实施例应如下操作:
导线的电极应植入(通过内窥镜或开放的切口)胃壁内或胃壁上以与胃平滑肌的周向层进行交流(参见图3)。由于胃的下部主要负责固体食物的混合和运动,植入电极较理想的位置是胃窦处,沿曲率较小的部分。之所以曲率较小的部分比较好是因为,与曲率较大的部分相比,其扩张较小,从而提供了一个较为稳定的位置。导线固定好后,IGS应连接到导线上并植入患者腹部皮下或表皮下的一个包裹里。
正常的胃电活动由基底的起搏区以大约每秒5mm的速度向幽门传播。当活动由胃窦向下传播时,通常会加速而且变得有组织(图8显示了一个正常的慢波沿胃从A点向F点的传播)。正常活动的脉动幅度、脉动宽度、以及频率(间隔)都与非正常活动不同。图9显示了可用于辨别/分类慢波的几个可辨识的参量。
当内活动经过一个植入的电极时,细胞的去极化会在电极上传递一个电势(与未产生去极的区域处的电极的差分比较)。如果这两个电极被编程作为传感电极,电势就传送到传感电路。在那里进行滤波和放大并传送到信息处理器。信息处理器(与所有RAM算法一起)将识别/分类此活动是正常抑或不正常。图10显示了一串胃活动波形及波形的分类。如果识别为正常,信息处理器就按照程序设定的参量启动刺激。如果识别为非正常,则微处理器重新启动传感。内部信号和刺激的某些参量记入RAM作为记录并用于其他算法。
本发明的一个可选装置分析了检测到的信号的频率成分以证明电反应活动是由收缩所引起的。如果信号包含与收缩有关的频率,则产生一个较强的刺激以破坏/扰乱或者减弱收缩。
本较佳实施例会根据测得的活动和程序设定的治疗机制产生一个或多个刺激治疗。刺激可能采用等交替极性的电脉冲序列、不等交替极性的电脉冲序列、及等或不等相位宽度的多相脉冲。刺激可在一个或多个点进行。图11描述了多(二)点刺激。进一步,刺激向量可在任何一对电极或一组电极中的至少一对中转换(在任一点)。(参见图6图7)。刺激机制描述如下:
(a)穿过慢波的刺激(图12)。穿过慢波的刺激发生于在位于慢波相对两侧的电极之间应用刺激的时候。此设计会在慢波引起细胞去极之前就使细胞去极。这将使细胞不受慢波的控制并在刺激区域造成慢波的减弱。穿过慢波的刺激有一个不足之处在于,一些细胞已经发生了去极化(慢波的结果),因而对这些细胞形成了能量的浪费。
(b)波前刺激(空间偏移)(图13)。在波传播的前方进行刺激的好处在于,接受刺激的细胞都未受波的影响。其缺点在于,必须考虑空间位移的度(长度和方向/定向)以保证在慢波到来前细胞不会再次极化。这就要求相应于传播路径,电极的配置相对固定。
(c)波前刺激(空间和时间偏移)(图14)。在波传播之前一段时间和空间偏移上的刺激包含有在一点的探测及在另一经过一段可由程序控制的延迟的点的刺激,以此确保细胞不会在波到来之前重新极化。它具有前面有空间提前量的方法的优点而不需要精确的电极定位就可以达到同样的效果。
(d)预刺激(通过时间延迟预测下一个波)(图15)。预刺激包括在一对电极之间的信号检测,以及将刺激延迟到预计刚好下一个正常波动要发生时。刺激可以应用于传感电极或传感电极上游的任何一组电极。延迟量由通过传感识别和参量存储所导出的正常时间间隔的记录计算得到。图16显示了一个正在进行的记录,用于计算下一个正常慢波到来之前所期望的时间选择。计算包括对整个正常间隔记录的平均减去一个小的时间间隔。图17显示了预刺激的间隔时间选择。
(e)去耦刺激(图18)。去耦刺激就是在一点检测蠕动收缩而在另一点产生强刺激以引起一个对抗性的收缩,此收缩会朝向胃内蠕动收缩传播然后离开。在两个收缩相遇时,会彼此抵消。由于在胃内运动之前发生,这种提前产生的收缩不会携带有肉糜,因而减低了胃活动的效率。
(f)异位刺激。异位刺激包含在不会有自发运动通过的区域使用比胃内运动间隔小的强刺激以破坏胃内电活动。较好的位置位于胃窦幽门处,此处大部分波动的传播都无法通过。
(g)综合的神经及胃刺激。综合的神经及胃刺激是指任何上述疗法的应用加上特定的抑制、阻碍胃的衰弱或者对其脱敏的刺激。这种刺激可能是一系列脉冲序列的联合,使神经或肌肉成分或单独的通道产生特定的神经或肌肉波形。
(h)比例刺激。比例刺激是前面任一种或所有刺激机制(除了异位刺激)的调节器。在比例刺激中,使用破坏、扰乱、或解耦刺激达到有效(正常)胃内活动的某一可由程序设定的比例。图19和20分别描述了扰乱正常慢波的25%和50%。(图20的一个可选装置可以每隔一个慢波扰乱一个。)这种刺激使医生可以调节内活动而仍保持某些正常功能。进一步,在胃内非正常活动增加时(比如患者生病时),由于有效的正常慢波数量减少,比例刺激的次数也会相应减少。
需要理解的是,本发明可用于许多不同的电生理刺激装置中,所有这些变化或应用都应当被看作是包含在本发明的范围之中。由于对这个关于胃的刺激和传感的设备的详尽叙述,显然对本领域中的普通技术人员来说,可以将本发明应用于上述较佳实施例以外的情况下。因此,本发明的范围包括替换形式、修改形式以及各种变化形式都应当由权利要求书来限定。
Claims (29)
1.一种对患者进行胃刺激的系统,其特征在于,它包括:
可植入的胃刺激器,包括信息处理器、传感电路、电刺激电路、电极转换电路、遥感电路、实时时钟、以及电源;
远端编程部件,可与所述可植入胃刺激器的遥感电路进行操作,以控制电刺激器及传感电路在信息处理器参与下的操作;
两个或多个电极,用于把电刺激信号从电刺激电路传送到患者的胃壁;以及
两个或多个电极,用于把检测到的胃电活动从胃壁传送到所述可植入电刺激器的传感电路。
2.如权利要求1所述的系统,其特征在于,它包含一个或多个拉长的具有近端连接头的导线体鞘,用来把所述刺激和传感电极与所述可植入胃刺激器连接起来,所述刺激和传感电极的导线通过拉长的导线体鞘伸出直至远端,所述拉长的导线体鞘的远端与患者胃壁传递信息,并用于所述刺激和传感电极在胃壁上或胃壁内的定位。
3.如权利要求1所述系统,所述多个刺激和传感电极可在胃壁的不同位置处定位。
4.如权利要求1所述系统的电极,所述电极的功能由可编程的电极转换电路控制。
5.如权利要求1所述的系统,其特征在于,所述可植入胃刺激器的遥感电路配有一个射频遥感收发机,用于与所述的远程编程部件交流信息。
6.如权利要求1所述的系统,其特征在于,所述信息处理器闭合可编程微处理器或微控制器。
7.如权利要求1所述的系统,其特征在于,在每天编制程序的过程中,所述系统可以临时转到节能状态。
8.如权利要求1所述的系统,其特征在于,所述传感电极将胃电信号传送到所述可植入胃刺激器的传感电路,用来通过信息处理器进行处理,用以识别内部电信号的间隔、幅度、及持续时间。
9.如权利要求8所述的系统,其特征在于,所述传感电极将胃电信号传送到可植入胃刺激器的传感电路,用来通过信息处理器的处理,识别内部电信号的频谱。
10.如权利要求9所述的系统,其特征在于,所述信息处理器分析电活动,并将其区分为是慢波还是蠕动波。
11.如权利要求10所述的系统,其特征在于,所述信息处理器分析固有的电活动,并将所述活动区分为是正常还是不正常。
12.如权利要求11所述的系统,其特征在于,当信号未达到可由程序设定的正常电活动的阈值时,所述系统会临时转到节能状态。
13.如权利要求12所述的系统,其特征在于,电刺激的刺激器传递是由区分为正常的电活动触发的。
14.如权利要求13所述的系统,其特征在于,刺激器可通过程序设定,对全部或部分正常传递电刺激。
15.如权利要求14所述的系统,其特征在于,所述电刺激可在内部电活动的过程中传递。
16.如权利要求14所述的系统,其特征在于,所述电刺激的传递可与内部电活动有空间位移。
17.如权利要求16所述的系统,其特征在于,所述电刺激的传递可与检测到的内部电活动有时间偏移。
18.如权利要求17所述的系统,其特征在于,所述电刺激可在预期到下一个正常电活动时传递。
19.如权利要求18所述的系统,其特征在于,所述时间偏移是可编程的。
20.如权利要求19所述的系统,其特征在于,所述电刺激的时间传递可由算法调整,此算法考虑了之前电活动的记录。
21.如权利要求20所述的系统,其特征在于,所述刺激电极的极性可由程序设定,使刺激能够在一对或多个电极中进行。
22.如权利要求21所述的系统,其特征在于,通过程序设定刺激器,使得能够进行一个或多个不同激励电极的极性转换,以达到多相激励。
23.如权利要求22所述的系统,其特征在于,所述电激励包括一个或多个二相脉冲,其可在以下参量范围内通过程序调整:
脉冲幅度在0.0到15V或0.0到15mA之间;
脉冲宽度在20毫秒到500毫秒之间;
每次作用有1到5个脉冲;以及
第一相的宽度为脉冲宽度的25%到100%。
24.如权利要求23所述的方法,其特征在于,所述脉冲宽度可通过在阵列中的两个或多个电容之间切换得到调整。
25.如权利要求22所述的系统,其特征在于,所述电刺激包括一个极性交替的脉冲序列,其可以在下列参量范围内通过程序调整:
脉冲幅度在0.0到15V或0.0到15mA之间;
脉冲宽度在100微妙到750微妙之间;
每秒脉冲数(频率)为10到120Hz;且
脉冲序列持续时间在0.5到30秒之间。
26.如权利要求25所述的系统,所述参数包括检测到的电活动的数量、间隔频率、持续时间、幅度及其它一些类似参量,并将这些量存储下来,以备以后调用。
27.如权利要求26所述的系统,所述探测到的固有波形可以传送到外部编程部件,以帮助建立适当的刺激参量。
28.如权利要求1所述的系统,其特征在于,所述刺激器可以整合一个或多个互相独立的可编程刺激或传感频道。
29.如权利要求28所述的系统,其特征在于,至少有一个刺激频道可通过编程调整为与神经刺激有关的参量。
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JP (1) | JP2004509714A (zh) |
CN (1) | CN1476339A (zh) |
AU (1) | AU2001293039A1 (zh) |
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US7941221B2 (en) | 2011-05-10 |
US20020072780A1 (en) | 2002-06-13 |
EP1322380A4 (en) | 2009-06-03 |
CA2421846A1 (en) | 2002-04-04 |
NO20031348D0 (no) | 2003-03-25 |
WO2002026317A1 (en) | 2002-04-04 |
NO20031348L (no) | 2003-05-23 |
US20040162595A1 (en) | 2004-08-19 |
JP2004509714A (ja) | 2004-04-02 |
EP1322380A1 (en) | 2003-07-02 |
WO2002026317A8 (en) | 2002-07-11 |
AU2001293039A1 (en) | 2002-04-08 |
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