CN101107040B - 用于经皮肤刺激人体的神经的装置 - Google Patents
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Abstract
本发明涉及一种用以经皮肤刺激人体的神经的装置(1),其具有一个刺激电极(2)和一个基准电极(3)用于经皮肤的神经刺激,所述一个刺激电极(2)和所述一个基准电极(3)与一控制单元相连接并且能由其供给电流,所述一个刺激电极(2)和所述一个基准电极(3)设置于一壳体(5)内或上,该壳体构成用于安装在人耳朵上或内。为了使神经刺激是有效的并且对于病人可易于操作,按照本发明建议,壳体(5)具有一弓形的延伸部(6),其构成用于插入耳道中,其中弓形延伸部(6)模仿耳道入口或外耳道的形状并且在弓形延伸部(6)的末端设置一电极头(7),其具有用于所述一个刺激电极和所述一个基准电极的两个触点(8、9)。
Description
技术领域
本发明涉及一种用于经皮肤刺激人体的神经的装置。
背景技术
同一种型式的装置以各种各样的方式是已知的。一经皮肤的神经刺激和肌肉刺激例如用于运动医学中用以刺激肌肉,其中为此将各电极安装或粘贴在皮肤上。优点是,当使电极就位时(电极的非侵入安置),不导致皮肤表面的创伤。同样上述可能性与其对立的是,将各电极植入皮肤内或其下面。
在用于经皮肤的神经刺激的装置中已知,通过神经的侵入的或非侵入的电刺激获得对其神经电的性质并从而对待刺激的神经的功能的影响。该处理方法的目的是,引起精神植物性的(psychovegetative)变化例如紧张下降或治疗神经精神病的障碍。
长期以来迷走神经的刺激具有特别的重要性。其例如是副交感神经系统的主神经的第十颅神经。此外它参与喉头和咽喉的运动机能的控制和转达舌根的味觉和来自咽喉、喉头和外耳道(耳支)的一部分的触觉。
特别是侵入的迷走神经刺激渐渐被看作是在神经学中为癫痫治疗建立的治疗方法。对此参阅Penry JK,Dean JC:Prevention ofintractable partial seizures by intermittent vagal stimulation inhumans:preliminary results.Epilepsia 1990;31 Suppl 2:40-43(通过人的间歇的迷走神经的刺激预防难治的部分的癫痫发作:初步的结果,癫痫1990年,31增补2:40-43页);和参阅Uthman BM,Wilder BJ,Hammond EJ,Reid SA:Efficacy and Safety of vagus nervestimulation in patients with complex partial seizures.Epilepsia 1990;31 Suppl 2:44-45(在具有综合的部分的癫痫发作的病人中迷走神经刺激的功效和安全,癫痫1990年,31增补2:44-50页)。
在这方面在神经外科上使病人在手术上露出迷走神经的左颈部并用一导电体作为电极包扎。将用于产生电流脉冲的器具在左肩部植入皮肤下面。此后可以借助于一电磁场从外面为迷走神经刺激器编制程序。通过电的迷走神经刺激在不同的区域实现脑的刺激,这在提供图像的方法中可以证实。除对癫痫的效用外刺激治疗还导致精神的效果,例如导致抗抑郁的效果,对此参阅Elger G,Hoppe C,Falkai P,RushAJ,Elger CE:Vagus nerve stimulation is associated with moodimprovements in epilepsy patients.Epilepsy Res 2000;42:203-210(在癫痫病人中与心境改善有关的迷走神经刺激,癫痫研究2000年,42:203-210页)。
因此该方法在最近的时期也用于精神病学并且在通常治疗抵抗的重抑郁症的治疗中已证明是合适的,对此参阅Carpenter LL,FriehsGM,Price LH:Cervical vagus nerve Stimulation fortreatment-resistant depression.Neurosurg Clin N Am 2003;14:275-282(用于治疗抵抗的抑郁症的颈的迷走神经刺激,神经外科临床标准改善2003年,14:275-282页);Goodnick PJ,Rush AJ,GeorgeMS,Marangell LB,Sackeim HA:Vagus nerve Stimulation indepression.Expert Opin Pharmacother 2001;2:1061-1063(抑郁症的迷走神经刺激,专用鸦片药物2001年,2:1061-1063页);Rush AJ,George MS,Sa ckeim HA,Marangell LB,Husain MM,Giller C,NahasZ,Haines S,Simpson RK,Jr.,Goodman R:Vagus nerve Stimulation(VNS)for treatment-resistant depressions:a multicenter study.BiolPsychiatry 2000;47:276-286(用于治疗抵抗的抑郁症的迷走神经刺激:一多中心的研究,生物精神病学2000年,47:276-286页)。
为了刺激神经总的来说已建议不同的解法。
US 5 458 625披露一种开头所述型式的装置用于借助于电脉冲刺激神经。其中借助于安置在病人的耳垂上的电极施加电流脉冲。
由JP 101 08 913A、DE 39 18 329 A1和FR 2 717 699 A1已知其他的用于在人体中施加电脉冲的解法。
EP 0 645 162 B1描述一种刺激器具用以刺激肌肉和神经,其包括一功能发生器用以产生一包括一序列脉冲的波形。其特别设定用于疼痛治疗。EP 0 757 573 A1和EP 1 064 047 A1总的描述用于电的神经刺激的系统和方法。
EP 1 145 736 A2中建议一种可植入的多模式的神经刺激器。EP 0972 538 A2描述一种系统用于借助于一针状电极在神经系统的一部分上发出一电刺激。EP 1 048 319 A2介绍一种系统用于选择性地激活脑神经、脊椎主质或周围的神经,其利用一可插入的针头工作。
EP 1 022 034 A1中描述一种方法和装置用于通过产生脉冲信号刺激肌肉或神经组织。EP 1 393 773 A1描述一种借助于一食道的电极的膈神经的神经刺激器。EP 0 962 234 A1描述一种装置用于电的神经刺激,其中未公开电极的定位。
WO 97/45160描述一种装置用以调整神经元的脑可塑性。WO01/00273描述一种非侵入的方法和装置用于借助于皮肤电极稳定心律。EP 1 420 854 A2将一横隔膜电极用于治疗神经精神病的障碍。最后,在EP 1 418 981 A1中在横隔膜附近实现一神经刺激用以治疗运动机能障碍。
在上述的解法中以下情况已证明是不利的。
众多的方法需要刺激电极的侵入安置并且除麻醉和一外科手术的通常的危险外还特别联系有神经伤害的危险和感染危险。
如果治疗显示没有成功,则必须将刺激器以如上述相同的危险再次撤出。
因此在必须接受一这样的手术的病人方面具有一阈限。
此外在某些情况下导致一植入身体的提供的机械的感觉并且其在需要时不可能以简单的方式免除。
并且描述的器具常常具有一大的不轻便的构造方式并因此只适用于临床的使用而不适用于家中的长时间刺激。
刺激器具和电极经常经由较长的电缆连接,这对操作起不利的影响。
一刺激由于操作(例如大的粘贴电极)只能在一固定的卧铺上实现,但在完成日常的工作时并不是不引入注目的和无妨碍的。
为了经皮肤的神经刺激方法的大面积的治疗使用值得追求的是,将技术结合于小型的便利的尽可能无电缆的装置中,其可以随时不复杂和不引入注目地携带。
发明内容
因此本发明的目的在于,进一步构成用于经皮肤刺激人体的神经的的装置,使其满足这样的要求。亦即拟提供一种用于神经刺激的装置,其能够实现迷走神经的特别有效的和简单的刺激而且以日常和简单的且几乎看不见的方式。该装置应该可特别简单地应用于病人并特别能够使其在必要时快速地从身体中撤出。同时拟建议一有效的外部的非侵入的装置用以刺激迷走神经部分,其特点是一高的携带舒适性,其中应该可以随时和不复杂地实现刺激。并且应该给病人一控制治疗的可能性。此外该装置应该针对一简单的稳定的和安全的刺激方法。
该目的通过本发明解法在于一种用于经皮肤刺激人体的神经的装置,该装置具有一个刺激电极和一个基准电极用于经皮肤的神经刺激,其中所述一个刺激电极和所述一个基准电极与一控制单元相连接并且能由该控制单元供给电流,其中所述一个刺激电极和所述一个基准电极设置于一壳体内或上,该壳体构成用于安装在人的耳朵上或内,为了各电极的优化的定位,壳体具有一弓形的延伸部,其构成用于插入耳道中,其中弓形的延伸部模仿耳道入口或外耳道的形状并且在弓形延伸部的末端设置一电极头,其具有用于所述一个刺激电极和所述一个基准电极的两个触点。
同时装置构成和适用于在外耳道和/或外耳的区域内刺激迷走神经。
优选控制单元设置于壳体中。但也可以设定,控制单元可从壳体取下并与各电极相连接。同时该连接可以是一导线连接,但也有可能是一无线的连接,例如一无线电连接。
电极头有利地由一软材料、特别是由保持软的硅树脂构成。各触点可以由金属球构成。它们也可以由平面的表面电极构成。此外有可能,各触点通过一由具有表面导电性的材料、特别是由具有石墨嵌件的海绵构成的元件构成。
控制单元可以适用于影响一流过电极的交变电流的频率。相应地适用于影响流过电极的电流的高低、影响流过电极的电流的脉冲的长短、影响流过电极的电流的时间上的刺激间隔和/或影响流过电极的电流的时间上的曲线(Verlauf)。
优选在装置中设置一可重新充电的电池,其向控制单元供给电流。
此外可以设定,装置具有一传感器用以测定病人的生理学的参数。在这方面可以例如涉及病人的脉搏或病人的血氧饱和度。此外可以设置一存储芯片用以存储借助于传感器测量的数据。
各电极可以结合于耳件或一移动电话的免提装置(Freisprecheinrichtung)的耳机中并且控制单元结合于一移动电话中。同时可以设定,各电极与控制单元之间的连接经由一无线电连接、特别是经由一蓝牙连接或一WLAN连接来实现。
由于迷走神经在外耳道的皮肤中也具有传入轨道,一电的迷走神经刺激通过耳的皮肤并从而非侵入地借助于一经皮肤的电极也是可能的。已证明成功的是,迷走神经的一电刺激经由在外耳道的传入导致一可导出的在头颅表面上的电位(感觉引起的电位)。
建议的方案因此刺激迷走神经的在外耳道的区域内延伸的神经分支(耳支)并这样承担对其功能的影响。这通过经皮肤的迷走神经刺激在一个在耳上或耳后待携带的刺激装置中的结合来达到,后者外表的形象类似一助听器。
用于迷走神经的外部的(非侵入的)刺激装置至今没有存在于耳朵区域内。在这里本发明消除各种弊端。上述已知的非侵入的神经刺激方法借助于电流应用将外围的神经刺激和肌肉刺激用于疼痛治疗(经皮肤的电的神经刺激-TENS)、肌肉锻炼(电的肌肉刺激-EMS)或确定的经络点的电针炙。这些方法没有哪一个设定用于在耳朵区域内刺激迷走神经,以便在中枢神经系统中引起变化。
与此相对,本发明针对在耳朵区域内的经皮肤的迷走神经刺激并为此建议一特别简单的待应用的装置。
利用本发明建议,因此一迷走神经的经皮肤的刺激特别用于神经精神病的障碍的治疗变成可能的,其中设置一在外耳道内或上定位的刺激电极用以经皮肤的刺激迷走神经的耳支以及一外耳道内或上定位的基准电极,其优选连接于一控制单元,后者支承在耳朵上或耳后。
如果使用耳件,则各电极接触外耳道的皮肤表面并可以这样刺激位于那里的迷走神经部分。
附图说明
附图中示出本发明的一个实施例。其中:
图1用于经皮肤刺激迷走神经的耳支的装置的简化电路图,
图2刺激器具,其构成为HdO(在耳朵的后面)器具。
具体实施方式
图1中绘出一用于经皮肤的迷走神经刺激的装置1的线路图。特别刺激耳支以便影响精神植物性参数。借此可以例如实现紧张的下降或可以有利地影响抑郁症或其他的神经精神病的障碍。
装置1基本上包括(图1中左边虚线示出的)刺激电极单元11和(图1中右边虚线示出的)控制单元4。
经由刺激电极2实现神经的刺激。基准电极3用作为电的基准点。两电极2、3构成刺激电极单元11。用于经皮肤的刺激的电极2和3是已知的、商业上可买到的或易于制造。
由控制单元4预定和产生刺激频率和刺激强度。这些参数的调整经由不同的控制元件12来实现。为了经皮肤的刺激需要振荡的信号。这由一位于控制单元4中的振荡器13产生。在一逻辑和控制电路14中实现输入和输出信号的处理,它们经由刺激电极单元11的输入或输出电路15供给。由一电池10承担供电。
如图2中可看出的,器具1在其构造方式上类似一在耳朵的后面携带的助听器并且具有一壳体5。将一电极头或一耳电极7形式的刺激电极单元插入外耳道中,从而刺激电极2和基准电极3贴靠皮肤表面。电极头7与图2中左边示出的壳体5的部分之间的连接构成为弓形的延伸部6,其也在刺激电极单元与控制单元之间引导整个输入线和输出线,沿外耳的上边缘敷设弓形的延伸部6。在连接或转接的末端,控制单元4位于尺寸大致为5cm×2cm×1cm的壳体5中。
在控制单元4中首先装入一刺激强度调整器16以便调整刺激信号的幅值(强度)。大的幅值多于低的幅值刺激神经。此外需要的刺激强度相互分别不同。
此外包括一刺激频率调整器17以便调整刺激信号的频率样本(Frequenzmuster)。这样可以同样快速控制接连的信号例如以一较大的间距接连的信号。
此外存在一接通/断开开头18用以激活或钝化装置1。一电池洞用于容纳一小型的钮扣电池,优选尺寸13至675。
一利用建议的装置对神经施加作用的实例表现如下:发出的电流在0.25与1.5mA之间。电流频率在20至30Hz之间。脉冲宽度在250与500μs之间。同时每3至5分钟发出约30秒的电流。
建议的刺激器具1是很小的并因此很好地适用于家中应用。其为载体提供一大的自由度,因为很有利和不妨碍地定位在耳朵的后面。
刺激电极和基准电极2、3必须具有对病人的皮肤表面的电触点,为此利用触点8或9,它们可以构成为金属小球。借此电极2、3贴紧耳屏的内面,亦即外耳的解剖学的部分。触点8、9之间的间距优选在1mm与15mm之间、特别优选在2mm与6mm之间。
为一解决方案设定,将耳件进一步插入耳道中并在那里同样实施一迷走神经刺激。为此可以将电极2、3例如构成为平面的表面电极。在耳道中较深地刺激迷走神经的其他的神经末梢。
电极2、3连接于(未示出的)电缆,其看不见地通入耳件。电缆连接又连接于优选在耳后面的控制单元4。如上所述经由弓形延伸部6实现连接。经由刺激频率调整器17实现刺激频率、刺激强度、脉冲持续时间以及刺激间隔和电流形式的调整。
类似于一耳内助听器,整个的技术也可以结合于器具中,将其置于外耳中并将外耳塞满。
器具利用电池10供给电流并从而独立于一外部的电源。同时可以设定,经由一可重新充电的电池10实现供电,其结合于壳体5中。为了充电过程将器具1置于一专用的小盒内,其连接于一外部的电源并且例如经由感应经过一夜向电池充电。
耳件可以另外设有一传感器用以测定脉搏和氧饱和,其中这样的用于测定呼吸功能和脉搏的传感器是已知的并且在商业上是可买到的。测量值可以记录在一存储芯片上,其在壳体5中位于耳的后面或耳内,以便其以后由一医生借助于一无电缆的接口读出并可以由软件评估。经由由软件算出的脉搏率变化性的变化,医生可以获得关于刺激装置的精神植物性的调整作用的重要信号并因此也得到关于治疗过程的控制数据。
描述的器具在其结构形式可以按标准数据实现,或耳件和其他的元件也可以分别制造。
另一实施形式设定,分开固定电极头7和控制单元4并经由一电缆相连接。
作为另一可能性可以设定,将刺激技术结合于一移动电话和其免提装置中。控制单元4和其电子系统在这里可以结合于移动电话的开关电路中。包括刺激电极和基准电极2、3的刺激单元7可以装入免提装置的耳件中。可以或无线地例如借助于蓝牙技术或经由一连接电缆实现耳件与移动电话之间的通讯。
此外有可能将技术结合于耳机和例如用于数字的传媒播放的装置中。这除MP3播放器外特别可以是MD播放器或CD播放器(Discman)。
附图标记列表
1 用于经皮肤刺激神经的装置
2 刺激电机
3 基准电机
4 控制单元
5 壳体
6 弓形延伸部
7 电极头
8 触点
9 触点
10 电池
11 刺激电极单元
12 控制元件
13 振荡器
14 逻辑和控制电路
15 输入或输出电路
16 刺激强度调整器
17 刺激频率调整器
18 接通/断开开关
19 电池洞
Claims (24)
1.用于经皮肤刺激人体的神经的装置(1),该装置具有一个刺激电极(2)和一个基准电极(3)用于经皮肤的神经刺激,其中所述一个刺激电极(2)和所述一个基准电极(3)与一控制单元(4)相连接并且能由该控制单元供给电流,其中所述一个刺激电极(2)和所述一个基准电极(3)设置于一壳体(5)内或上,该壳体构成用于安装在人的耳朵上或内;其特征在于,壳体(5)具有一弓形的延伸部(6),该延伸部构成用于插入耳道中,其中弓形的延伸部(6)模仿耳道入口或外耳道的形状并且在弓形延伸部(6)的末端设置一电极头(7),该电极头具有用于所述一个刺激电极(2)和所述一个基准电极(3)的两个触点(8、9)。
2.按照权利要求1所述的装置,其特征在于,该装置构成和适用于在外耳道和/或外耳的区域内刺激迷走神经。
3.按照权利要求1或2所述的装置,其特征在于,控制单元(4)设置于壳体(5)中。
4.按照权利要求1或2所述的装置,其特征在于,控制单元(4)能从壳体(5)取下并与所述一个刺激电极(2)和所述一个基准电极(3)相连接。
5.按照权利要求4所述的装置,其特征在于,该连接是一导线连接。
6.按照权利要求4所述的装置,其特征在于,该连接是无线的。
7.按照权利要求1或2所述的装置,其特征在于,电极头由一软材料构成。
8.按照权利要求1或2所述的装置,其特征在于,触点(8、9)由金属球构成。
9.按照权利要求1或2所述的装置,其特征在于,触点(8、9)由平面的表面电极构成。
10.按照权利要求1或2所述的装置,其特征在于,触点(8、9)通过一由具有表面导电性的材料构成的元件构成。
11.按照权利要求1或2所述的装置,其特征在于,控制单元(4)适用于影响一流过所述一个刺激电极(2)和所述一个基准电极(3)的交变电流的频率。
12.按照权利要求1或2所述的装置,控制单元(4)适用于影响流过所述一个刺激电极(2)和所述一个基准电极(3)的电流的高低。
13.按照权利要求1或2所述的装置,其特征在于,控制单元(4)适用于影响流过所述一个刺激电极(2)和所述一个基准电极(3)的电流的脉冲的长短。
14.按照权利要求1或2所述的装置,其特征在于,控制单元(4)适用于影响流过所述一个刺激电极(2)和所述一个基准电极(3)的电流的时间上的刺激间隔。
15.按照权利要求1或2所述的装置,其特征在于,控制单元(4)适用于影响流过所述一个刺激电极(2)和所述一个基准电极(3)的电流的时间上的曲线。
16.按照权利要求1或2所述的装置,其特征在于,在该装置中设置一可重新充电的电池(10),该电池向控制单元(4)供给电流。
17.按照权利要求1或2所述的装置,其特征在于,该装置具有一传感器用以测定病人的生理学的参数。
18.按照权利要求17所述的装置,其特征在于,生理学的参数是病人的脉搏。
19.按照权利要求17所述的装置,其特征在于,生理学的参数是病人的血液的氧饱和。
20.按照权利要求17所述的装置,其特征在于,所述装置具有一存储芯片用以存储借助于传感器测量的数据。
21.按照权利要求1所述的装置,其特征在于,所述一个刺激电极(2)和所述一个基准电极(3)结合于耳件中并且控制单元(4)结合于一移动电话中。
22.按照权利要求1所述的装置,其特征在于,所述一个刺激电极(2)和所述一个基准电极(3)结合于一移动电话的免提装置的耳机中并且控制单元(4)结合于该移动电话中。
23.按照权利要求21或22所述的装置,其特征在于,所述一个刺激电极(2)和所述一个基准电极(3)与控制单元(4)之间的连接经由一无线电连接来实现。
24.按照权利要求1或2所述的装置,其特征在于,所述一个刺激电极(2)和所述一个基准电极(3)结合于一音乐播放装置的耳机中并且控制单元(4)结合于该音乐播放装置中。
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SI1843814T1 (sl) | 2008-10-31 |
RU2393884C2 (ru) | 2010-07-10 |
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DK1843814T3 (da) | 2008-09-29 |
CA2594478A1 (en) | 2006-08-03 |
WO2006079484A1 (de) | 2006-08-03 |
KR20070107067A (ko) | 2007-11-06 |
EP1843814B1 (de) | 2008-05-21 |
CN101107040A (zh) | 2008-01-16 |
EP1843814A1 (de) | 2007-10-17 |
RU2007132162A (ru) | 2009-03-10 |
CA2594478C (en) | 2013-06-25 |
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