CN105307719B - 局部神经刺激仪 - Google Patents
局部神经刺激仪 Download PDFInfo
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- A61N1/0408—Use-related aspects
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- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0472—Structure-related aspects
- A61N1/0476—Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
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- A61N1/0404—Electrodes for external use
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- A61N1/0492—Patch electrodes
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
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Abstract
一种局部神经刺激仪粘块和系统，包括一个皮肤粘块；一个与粘块相关联的电信号发生器；一个启动电信息发生器的信号接收器；一个与粘块相关联的电信号发生器的电源；一个电信号启动装置；以及一个神经反馈感应器。
Description
优先权要求
本申请要求2013年5月30日提交的第61/828981号美国临时专利的优先权，上述申请的内容以引用方式全文并入于此。
版权声明
2013年及2014年GRAHAM CREASEY，MD，&HOO-MIN TOONG，PhD.本专利文件包含受到版权保护的材料。版权所有人对任何人复制专利商标局档案显示的专利文件或文献不持异议，但声明保留所有版权权利。
技术领域
本发明涉及通过局部刺激来激活人体及哺乳动物神经以控制或影响肌肉、组织、器官或包括疼痛在内的感知。
背景
神经紊乱可导致肌肉和其他身体功能失控、感知或疼痛感知的丧失。外科手术及药物有时可治疗这些紊乱，但有局限性。本发明涉及一种为功能治疗和改善提供其他选择选择方案的系统。
附图简要说明
图1描述了通过电脉冲的方式使神经元激活肌肉。
图2显示了神经内电脉冲潜在的电激活时间。
图3为阴茎的横截面。
图4为包括一个芯片系统(SOC)的局部神经刺激器/感应器(TNSS)的部件结构。
图5为TNSS实施例Smart Band AidTM(SBA)仪器的顶部图，其显示可以是不同型号的电池。
图6为图5所示SBA的底部图。
图7为包括了TNSS部件的SBA。
图8为置入SBA仪器可选择的神经刺激器及感应器芯片组的示例。
图9为SBA可选的电极结构示例。
图10为在一组系统及软件应用中一个使用带有控制单元的TNSS系统示例。
图11显示使用诸多射线形成及控制波束的方法。
图12为波束形成和控制机制的示例。
图13为激活神经刺激仪控制单元的示例。
图14为连接控制单元和TNSS、采集数据、与其他TNSS和外部通讯实现网络连接的软件平台示例。
图15为脊髓损伤病人应用TNSS。
图16为TNSS系统的示例。
图17显示了图16TNSS系统各部件与使用者之间的通讯。
图18显示了电场控制和感应的电极结构示例。
图19为组织中刺激和感应信号模式的示例。
详细说明
一种采用放置于皮肤并可与手机、激活仪或计算机网络无线连接并控制的小型电子设备实现与人体或哺乳动物神经系统电子、机械、化学和/或光学互动以激活和/记录身体功能的方法。
人体由化学系统和神经系统控制。神经和肌肉产生电压和电流并对其有反应。对这些组织实施电刺激可恢复丧失的运动和感知，或者可改变神经系统的行为，这一过程称为神经调节。
记录神经和肌肉的电活动广泛应用于诊断，如心电图、肌电图、脑电图等。电刺激电记录需要输入和输出信息的电界面。
组织和电子系统之间的电界面通常有三种：
a、外科植入体内的仪器，如心脏起搏器。这些仪器针对多种功能而开发，如恢复瘫痪肌肉的运动或恢复听力，潜在地也可应用于任何神经或肌肉。这些是典型的专业性高且费用高昂的仪器。
b、临时插入体内的仪器，如与其他体外设备连接的针头或导管。医疗人员利用这些设备进行诊断或短期治疗。
c、从皮肤表面记录电压用于诊断和数据采集，或采用与刺激仪连接的粘块在皮肤表面实施电激的仪器。便携式由电池驱动的刺激仪是典型的由病人操作的简易仪器，例如用于减轻疼痛的仪器。它们的使用受如下限制：
i.需要对线路、粘块和电激仪长期管理带来的不便，尤其是在有多个界面的情况下，以及
ii.对于病人来说，控制多种电激参数的困难，如幅度、频率、脉冲宽度、任务周期等。
神经也可以机械的方式被刺激以产生感知或激起或改变反射；这是触觉和触觉反馈的基础。神经也可通过局部或系统用药以化学的方式影响，有时根据位置或化学类型以针对特殊的靶标。神经也可以光学方式被刺激或抑制，如眼睛内一些还有光感基因的神经。神经活动也会产生可以感应到的电、机械及化学变化。
局部神经刺激仪/感应仪(TNSS)为置于人体或哺乳动物表面，作用于并反应于神经、肌肉或组织，以刺激神经并感应身体的活动。TNSS的一个实施例为Smart Band AidTM(SBA)。一个S包括BA仪的系统控制神经调节和神经刺激活动。其包括一个或多个控制器工控制单元，一个或多个TNSS模块、内嵌于控制单元及TNSS模块的软件、上述部件间的无线通讯以及数据管理平台。控制器内的软件控制TNSS的功能。控制器采集来自TNSS的数据或影像数据，并通过上述软件进行分析。控制器提供一个显示及记录来自使用者信息的物理使用者界面，如激活或中断TNSS，数据和使用者统计数字的录入以及产生报告数据。最后，控制器提供与其他控制器或互联网云的通讯。
控制器建立与神经刺激模块(也称为TNSS模块或SBA)以及使用者的通讯。在至少一个以上的实施例中，上述通讯均是双向的，因此每一组通讯是一个控制环。可选择的是，在TNSS模块和身体之间有直接的控制环。因此系统可选择是一个还有至少4个控制环的分层控制系统。TNSS和身体之间为一环；TNSS和控制器之间为一环；控制器和使用者之间为一环；控制者和其他使用者通过云实现另一环，上述控制环内嵌于TNSS、控制器或云，其具有以下功能：(1)通过网络如蓝牙在控制器和TNSS之间传送激活或中断信号；(2)在控制器收到使用者的命令时，驱动用户界面向使用者提供图像、声音或触觉反馈；(3)在TNSS、和/或控制器和/或云内分析TNSS数据以及其他来自使用者的反馈；(4)决定适当的处理方式；(5)系统诊断操作的正确性；(6)通过互联网云与其他控制器或使用者进行通讯，以实施数据传送或交换，或与内嵌于互联网云的应用互动。
控制环是封闭的。这是同时具有刺激和感应两种功能的结果。感应提供关于刺激效果的信息，使刺激能被调节到理想水平或自动改进。
典型的情况是施加刺激。感应用来测量刺激的效果。感应到的测量值用来确定下一刺激。这一过程可无限重复，每一部分可有不同的持续时间。例如：快速循环过程(a-b-c-a-b-c-a-b-c)；延长刺激，偶尔感应(aaaa-b-c-aaaa-b-c-aaaa-b-c)；延长感应，偶尔刺激(a-bbbb-c-a-bbbb-c-a-bbbb)。当发现身体出现状况，且这一信息用来确定治疗的刺激或修复身体状况时，上述过程也可开始于感应，如(bbbbbbbbb-c-a-bbbbbbbb-c-a-bbbbbbbbb)。其他模式也是可能的，并在本发明应用范围之内。.
通过在刺激电路和感应电路间切换，同一部件可交替用来刺激和感应。所述切换可通过标准的电子部件实现。同样的电极可同时用于电激和电感应。一个电子开关用来连接刺激电路与电极，使电刺激实施于组织。然后断开电子开关中断刺激电路与电极的连接，将感应电路与电极连接，以记录来自组织的电信号。
在声音刺激和感应的情况下，同样的超声传感器可用于两种模式(如超声成像或雷达)。采用一个电子开关将电路与传感器连接，以将声音信号(声波)传送到组织。接着电子开关将电路与传感器断开，并将其他电路与传感器连接(收听反馈的声波)，同时这些来自组织的声音信号被记录。
还可采用其他模式的刺激和感应(如光、磁场等)。闭环控制可由单个TNSS独立实施，或者如图16所示由系统内的多个TNSS模块实施。感应可由一些TNSS完成，而刺激由另外一些TNSS完成。
刺激仪是协议控制的电刺激的发起者，其中相关协议内嵌于TNSS和/或控制器和/或云。刺激仪与相应的感应器或激活器互动，如电极或MEMS仪器。
内嵌于TNSS、控制器或云的协议的几个功能包括：
(1)通过本地网络如蓝牙在控制器和TNSS之间传送启动或断开信号。协议通过蓝牙无线电波将信号从智能手机传送到皮肤上的TNSS模块，指令其启动或停止刺激或感应。其他无线通讯方式也可实施。
(2)当控制器收到使用者的指令，其驱动使用者界面向使用者提供图像、声音或触觉反馈信号。当使用者触碰智能手机屏幕上的小窗时，协议收到使用者的指令，并通过在智能手机屏幕上显示信息向使用者提供反馈，或使智能手机发出嘀嘀或嗡嗡声。
(3)在TNSS和/或控制器和/或云内分析TNSS数据以及其他来自于使用者的反馈数据。协议分析TNSS感应到的数据，如肌肉位置，以及来自于使用者的数据如使用者触碰智能手机屏幕所表达的愿望；这些分析可在TNSS、智能手机和/或云内完成。
(4)做出适当处理的决定。协议使用其分析的数据决定实施刺激的内容。
(5)系统诊断操作的正确性。协议检查TNSS系统是否运行正确。
(6)通过互联网云传送或交换数据与其他控制器或使用者进行通讯。协议通过无线网络与其他智能手机或人员进行通讯；这包括在互联网上传送数据，或在互联网其他地方运行的计算机程序。
一种设置于一个生态系统或模板化平台的神经控制系统、方法及仪器，其可能采用一次性的局部装置为电子计算系统和神经系统之间提供界面。这些界面可以是通过电极方式的直接电连接或通过传感器(感应器及促动器)的间接方式。其各种不同的结构可具有以下元件：感应或启动身材内电事件的电极；各种模式的促动器；无线网络；协议应用，如数据处理、记录、控制系统。这些元件集成于一次性局部装置。上述集成使局部装置可自主运行。局部装置还可带有遥控单元(通过天线、传送器和接收器进行无线通讯)以实现自主运行。
参见图1，神经细胞通常为电极化，神经内部与其外部相比的电势为负70MV。为神经细胞施加适当的电压(将细胞的静态电位从-70mV升到启动阈值-55mV以上)可启动一系列事件，其中在细胞膜的一个区域的电极短暂反转，电极的变化分布于整个细胞的长度并影响一定距离外的其他细胞，如与其他神经细胞联系或引起或防止肌肉收缩。
图2为从一个刺激点的神经脉冲引致一波去极化以及接下来的重新电极化，并在测量时间内通过神经细胞膜。这一分布的电势运动即神经脉冲。这一现象允许外部神经电激。
如图3所示，阴茎或阴蒂皮肤下的生殖器背部神经为纯粹的触觉神经，其通常在性行为过程中抵制膀胱的活动，对上述神经的电激已经证明可减轻尿频症状。对阴茎下部的电激可导致性唤起、勃起、射精和高潮。
局部神经刺激仪/感应器(TNSS)用来刺激上述神经，其使用方便、体积小、自主提供能量、并由智能手机或其他控制装置控制。其优点在于无创、由使用者本人控制，并不需要处方。
参见图4，TNSS具有一个或多个电子电路或芯片，其完成如下功能：与控制器联系、通过一个或多个产生较大范围电场的电极408根据治疗需要实现神经刺激、可作为电极和通讯通道的一个或多个天线410、以及多种型号的感应器406，包括但不限于机械运动和压力、温度、湿度、化学和定位感应器。一种方案是将上述功能集成到芯片400的SOC系统。在上述系统中包括一个数据处理、通讯和存储的控制单元402，一个或多个与电极408连接的刺激仪404和感应器406。还包括一个控制单元实现外部通讯的天线410。所示系统还包括内部电源412，例如电池。外部电源是芯片结构的另一变体。有必要包括多个芯片，以提供数据处理和刺激的较大范围的电压。电子电路和芯片通过装置内具有传送数据和/或电源的导电轨实现通讯。
在一个或多个实施例中，一个SBA仪器为一个可粘附于皮肤的导电粘块的形式，其包括一个电池、电子电路和电极，电激从粘块传导到组织。典型的电激为一系列可调电压的方波，频率为15到50HZ，电流为20到100MA。使用者通过智能手机控制电激。电激可由使用者在需要的时候启动、或根据预设的时间进行程控、或根据SBA仪器上的感应器或其他部件检测到的事件进行启动。另一个为男性设计的TNSS实施例是一个包括电激仪的环状导电设计，放置于需要电激的阴茎部位。
如图5所示，采用有限供电周期的电池作为内部电源412，为本图中的SBA仪器提供电源。电池可以是锂离子电池或传统的无毒的锰电池。图5显示了不同的电池选择，如锰电池516和纽扣电池518。不同形状的TNSS可能需要不同的电池。
图6显示了上述部件一个可选的实施例，其中电池616-681位于SBA仪器底部的电极610和612之间。在此实施例中，电池616为锂电池，电池617为锰电池，而电池618为钮扣电池。本专利申请的范围内还可采用其他型号的电池和电池装置。
除了控制器外，SBA仪器的包装平台还包括可放置于皮肤表面的粘块组件，并包括上述的TNSS电子部件、协议和电源。
如图7所示，TNSS采用SBA仪器414。所述仪器带有一个基板，其一面带有可粘附于皮肤的粘带，图4所述的SOC400或电子包，一个或多个在粘带表面和皮肤之间的电极408。电极通过皮肤为神经和其他组织提供电激，也可从身体采集电信号，如肌肉收缩时产生的电信号(肌电图)，以提供包括肌肉运动在内的身体功能的数据。
如图8所示，根据设计要求可采用不同的芯片。图中所示为应用于TNSS的SBA仪器的芯片实施例。所述实施例提供了神经电激仪800、感应器802、处理器/通讯装置804。芯片可在基板上单独包装，包括一个弹性材料，或者作为芯片系统(SOC)400。图中未显示芯片的连接和电子装置，但为本领域公知技术。
图9所示的SBA仪器具有不同电极装置的变体。每一电极包括多个导电轨，使电极可调节所实施电场的深度、方向以及空间分布。在所有电极装置实施例中，电极901-904的电激深度可通过施加于电极的电压和电流来控制。电流可施加于SBA仪器的另一端的各个电极，或仅施加于SBA仪器一端多个电极。施加于电极的信号的相位关系根据电场的方向性而不同。在所有设计结构中，电极施加的信号在时间和空间范围内都会不同。左边的设计结构901中，在SBA仪器的两端均有多个同轴的电极接头。采用这一设计结构可通过施加于电极接着电源的变化实现在各种组织深度上提供电激场。接下来的设计结构902中，电极404是以多个平行电接头的形式布局。这种方式使电场的定位垂直或平行于SBA。下一个设计结构903中，电极接头是以矩阵形式布局，电激场在SBA仪器任一端的任何两个或多个电极接头之间产生，或在SBA仪器一端单一的矩阵内的两个或多个电极接头之间产生。最后，在最右边的设计结构904中，电极是以多个平行的电接头形式布局的。和第二种设计结构一样，电场的定位是垂直或平行于SBA仪器。电极和接头还可以有许多其他的布局。
一个或多个TNSS与一个或多个控制器组成一个系统。各系统和分配的虚拟处理和存储服务之间互相联系并互动。通过这一方式，多个系统间可实现医疗及非医疗应用的数据采集、交换及分析。
如图10所示，该系统具有两个TNSS单元1006，一个在腰上，另一个在腿上，系统与控制器、一部智能手机1000或其他控制装置进行通讯。TNSS单元可以同时是感应和刺激单元，既可以独立工作也可在身体区域网络(BAN)中一起工作。系统之间的通讯通过通讯桥或包括蜂窝网络在内的网络完成。系统还可通过互联网1002与分布式虚拟处理和存储环境中的应用程序进行通讯。与分布式虚拟处理和存储环境中的应用程序进行通讯的目的是传送大量的使用者数据以进行分析，并与其他第三方进行联络，如医院、医生、保险公司、研究人员等。从多元系统1004采集、交换、分析数据的应用程序有不少。第三方应用的开发人员可进入TNSS系统及其数据以实现多种应用。这些应用可向穿戴TNSS单元1006的个人反馈数据或控制信号。这些应用还可向其他采用系统1008的成员传送数据或控制信号。所述数据包括个人数据、多个使用者的叠加数据、数据分析或其他来源的辅助数据。
在图11所示的实施例中，电极的布局影响波束形成及波束控制。波束形成和波束控制使TNSS对于神经和组织的电激有更多可选的应用。波束控制通过对目标实施定向刺激机制提供了为包括神经在内的细胞实施低能量电激的机会。采用低能量电波束延长了电池寿命，并可能采用低能量芯片组。波束控制通过磁场及形成通道等多种方式实现。图11显示了一种通过使用多个射线1102形成和控制波束的方法，所述射线由普通电源1104供电的相位位移仪1103激活的相互作用的相位实现。由于放射信号在相位之外，其产生干预模式1105，实现在各种控制的方向1106上组成和控制波束。电磁射线和光线一样具有波束特征，可集中于某一位置。这为有选择地电激神经等组织提供了可能。其还为将能量和数据的传送集中于某一物体提供了可能，如局部或植入的电子装置，这样不仅改进了启动或控制上述物体的可选择性，而且降低了运行所需的总电能。
图12是另一个用于波束形成和控制1202的通道结构1200的实施例。通道结构1200还包括一对通过时间变化电压的应用实施简单波束形成的波互锁电极。波束控制1202显示了主电场图以及波束控制的工作原理。图12显示了一个可能的实施例。
人类和哺乳动物的身体是一个各向异性的媒介，其多层组织具有不同的电特征。采用多种电极或多种SBA仪器，并利用人或哺乳动物的身体作为各向异性的电导体实现电场的控制。结合图18和19将讨论电场的控制。
如图13所示，控制器是一个电子平台，如智能手机1300，平板电脑1302，个人电脑1304，或其他具有无线通讯功能的专用模块1306，如现有通讯芯片(例如宽带通讯BCM4334、TI WILINK8等)支持的近场通讯、蓝牙或WIFI技术以及其他多种能与TNSS实现通讯的协议应用。其还可包括多个一起工作的控制器，例如使用者不仅安装了控制应用程序的智能手机，同时口袋或钱包里还与钥匙链类似的控制器。
TNSS协议实现与控制器通讯的功能，包括传送和接收控制和数据信号，神经电激的启动和控制，从主板感应器采集数据，与其他TNSS进行通讯和协作以及数据分析。通常TNSS从控制器接收指令，产生电激并实施于组织，感应组织信号，并将上述信号传送给控制器。其也可分析感应的信号并根据这一信息修改实施的电激。除了与控制器进行通讯外，其还通过身体区域网络利用电或无线电信号实现与其他TNSS的通讯。
如图14所示，控制器协议在智能手机1400、平板电脑1402或其他计算机平台或移动设备上执行并显示，其还实现与TNSS模块进行通讯的功能，包括传送和接收控制和数据信号、启动和控制神经调节方案、从主板感应器采集数据、与其他控制器通讯和协作以及数据分析等功能。在有些情况下，控制协议实施本地的神经调节方案，而不需要与使用者进行通讯。
图15显示了身体电激及感应的可能应用，尤其是身体瘫痪或者失去知觉的使用者，或者因神经紊乱和并发症导致的反应变化，如痉挛或震颤，以及遭受失禁、疼痛、无行动能力及老年病。本系统的不同医疗的应用将在下面描述。
图16为一个典型TNSS系统1600实施例的部件。TNSS装置1610负责电激神经，接收表现为电、声音、图像、化学及其他信号的数据并在本地处理或传送给控制单元1620。TNSS装置1610可包括多个用来电激或感应的电极。同一个电极可用于两种功能，但并非必须。TNSS装置1610可包括一个成像装置，如一个超声波传感器，以产生电极下结构或电激影响的身体其他部分的声音图像。
在TNSS系统的实施例中，大部分数据的采集和分析由控制单元1620完成。控制单元1620可以是手机或一个专用硬件设备。控制单元1620运行一个应用软件，以控制TNSS系统1600的本地功能。协议应用软件通过互联网或无线网络1630与其他TNSS系统和/或第三方应用软件实现通讯。
图17为TNSS系统1600的各部件和使用者之间的通讯。在此实施例中，TNSS1610可以神经1640进行刺激，以在神经1640中产生反应电位，在肌肉1670或其他器官，如大脑1650中产生反应。TNSS1610可感应这些反应，并根据获得的信息调节其提供的电激。这一闭环构成本实施例系统1600的第一层。
TNSS1610还可根据从手机、笔记本电脑、钥匙链、平板电脑或其他手持设备等控制单元1620接收到的信号进行工作，也可其感应到的信息传回控制单元1620。这构成本实施例系统1600的第二层。
控制单元1620根据使用者的指令进行工作，同时使用者也从控制单元1620接收信息。使用者还可通过自然感应，如通过感觉神经和脊髓实现的视觉或触觉，接收信息，同时在某些情况下，通过脊髓到肌肉的自然通道产生身体的反应。
控制单元1620可将信息通过互联网1630传送给其他使用者、专家或应用程序，并从互联网1630接收信息。
使用者可选择使用内嵌于TNSS1610、控制单元1620、互联网1630或无线网络的协议应用启动或修改工作流程。这一软件有助于使用者，例如通过处理施加于身体的电激，使其对于使用者更具选择性和有效性，和/或通过处理及显示从身体或互联网1630或无线网络接收到的信息，使其对于使用者更易懂或更有价值。
图18为电场控制的电极设计1800的实施例。对身体施加适当的电场可引起神经产生称为反应电位的电脉冲。电场的形状受到其通过的不同组织的电特性以及采用电极的大小、数量和位置的影响。因此电极可以设计用来定型或控制电场或将电场更加集中于某些神经，从而提供更有选择性的电激。
图中显示了10x10矩阵布局设计的电接头1860的实施例。通过改变产生电场1820采用的电接头1860的模式以及改变给予电接头1860的供电，可以控制电场以三维形式通过身体不同的部分，可包括肌肉1870、骨骼、脂肪及其他组织。这一电场1820可以激活神经或神经束1880，同时感应产生的电及机械反应1890，从而使TNSS可以实现更有效或最有效的产生理想反应的电激模式。
图19显示了一定数量组织内信号电激及感应模式的实施例。作为环状设计的电极1910放置于肢体1915周围。电极1910置于肢体1915上的皮肤1916的外面。肢体1915内的组织包括肌肉1917、骨骼1918、神经1919及其他组织。如图18所述，通过采用电场控制进行电激，电极1910可有选择性地激活神经1919。TNSS内的一组感应器(如压电感应器或微型电机感应器)可实现接收超声波信号的相位天线的功能，以获得身体组织的超声波图像。电极1910可实现一组在人体身体表面的不同位置并在不同时间感应电压的功能，同时软件处理这一信息并显示身体组织活动的信息，例如不同的电激模式激活哪类肌肉。
SBA仪器刺激并且收集器官信息的功能具有多种用途，包括控制膀胱、反射性失禁、性刺激、疼痛控制以及伤口愈合等。SBA仪器的医疗及其他用途将在下面描述。
医疗用途
膀胱管理
1)尿频：当使用者感觉需要紧急排尿时，其可按下控制器上的按钮启动SBA仪器刺激阴茎或阴蒂上的生殖器神经。激活这一神经将抑制紧急排尿感，使用者可在方便的时候再排尿。
2)失禁：因膀胱不必要地收缩而导致尿失禁的病人使用SBA仪器刺激阴茎或阴蒂上的生殖器神经来抑制膀胱收缩以减少尿失禁。当使用者感觉有失禁风险或感应器感应到膀胱尿量或压力而做出反应时，可以持续或间歇性地刺激神经。
勃起、射精和高潮：通过SBA仪器刺激阴茎背部神经(电激或机械振动)可导致性兴奋，也可用来产生或延长勃起时间并产生高潮和射精。
疼痛控制：身体特殊部位慢性疼痛的病人在疼痛区域采用SBA仪器对神经进行提供触觉的电激，从而减轻该区域的疼痛感。这基于疼痛的门控理论。
伤口管理：身体有伤口或溃疡的使用者采用SBA仪器对伤口周围的组织进行持续电激从而加快伤口的愈合和降低感染可能。
特发性震颤：SBA仪器上的感应器检测到震颤时，其启动针对震颤相关的肌肉和感觉神经的进行适当的频率和震颤相位关系的电激。通常电激的频率与震颤频率相同，但为了取消震颤或重新设置手部位置的神经控制系统电激的相位会移动。
减轻痉挛：对周边神经进行电激可在电激后几小时减轻痉挛症状。需要时患者可通过智能手机操作SBA仪器进行电激。
恢复知觉和感觉反馈：，如由糖尿病或中风导致失去知觉的患者使用SBA仪器感应移动或接触，比如脚踏上地板，同时SBA仪器对使用者有感觉的身体其他部分进行电激，以改善安全性或身体功能。通过在SBA仪器采用声音传感器来提供机械刺激，如小型震动器。在身体上采用SBA仪器或其他辅助装置提供来自人造身体的感觉反馈。感觉反馈还可用来代替另一种感觉，如以触觉代替视觉。
记录身体的机械运动：SBA仪器内(Smart Band AidTM)的感应器记录人体或身体器官的姿态、位置和方向并将上述数据传送到使用者的手机和/或其他计算机网络，以进行安全监测、分析刺激的作用和协作方式。
记录身体的声音以及SBA仪器内的传感器产生的超声波的反馈信息可提供关于身体结构的信息，例如，膀胱失去知觉患者的膀胱人尿量。声音传感器可以是压电装置或MEMS装置，用来传送及接收适当的声音频率。声音数据可经处理实现身体内部成像。
记录身体的电活动
心电图：记录心脏的电活动广泛用于心脏病和心率不齐的诊断。有时需要24小时或更长时间内记录上述活动以检测不正常的心率。SBA仪器通过与智能手机或计算机网络进行通讯可比传统仪器更简单地实现上述检测。
肌电图：记录肌肉的电活动广泛用于神经科的诊断和运动分析。现有的方法需要在皮肤表面扎多根针或绑上粘块，并通过多根线与设备相连。多功能SBA仪器记录多种肌肉的电活动并将信息以无线方式传送到智能手机。
记录身体的光学信息：一个包括光源(LED或激光)的SBA仪器对组织照射并感应反射光的特征以测量特征值，如血液的含氧量，并将这些信息传送到手机或其他计算机网络。
记录身体的化学信息：SBA仪器的感应器持续监测身体内或体液内的化学物或药物水平并传送到其他网络，同时向使用者或医护人员提供适当的反馈。化学物水平的测量可通过光学方法(在特定波长上的光反射)或化学物感应器实现。
特殊残障使用者人群
治疗和功能恢复的电激有多种可能的应用。然而，很少有应用商业化，原则是缺少费用合理、方便携带且控制简易的电激系统。图15中显示了一些应用。
身体肌肉刺激：下肢肌肉如果因为中风或脊椎损伤瘫痪可通过电激进行锻炼。这一锻炼方式通常与固定的健身自行车相结合，以实现稳定性。SBA仪器可应用于大腿的肢四头肌进行电激，使膝盖往复伸展，或应用于如腿肚子上的其他肌肉。SBA仪器内的感应器可通过智能手机、平板电脑、钥匙链等手持硬件设备、可穿戴计算机设备、笔记本电脑、或台式电脑等其他可能的设备上的应用程序在锻炼周期内适当的时间启动电激。上肢肌肉如果因为中风或脊椎损伤瘫痪可通过电激进行锻炼。这一锻炼方式通常与手臂曲柄健身器械相结合，以实现稳定性。SBA仪器应用于上肢的多种肌肉，并由SBA仪器内的感应器通过智能手机上的应用软件在适当的时候启动。
防止骨质疏松：锻炼可防止骨质疏松和病理性骨折。采用SBA仪器与划浆模拟器等健身器械相结合，即便对于特别容易发生骨质疏松的瘫痪病人也可以应用。
防止深度静脉血栓：腿肚肌肉的电激可降低深度静脉血栓，尤其是致命的肺栓塞的风险。SBA仪器的腿肚肌肉的电激在外科手术进行时可通过智能手机的电激程序实施，或在长途飞行中按照预先设定的程序实施。
功能恢复(功能电激)
下肢
1)脚落地：中风病人通过不能抬起前脚并将脚趾落在地面上。SBA仪器应用于膝盖下的腓神经并刺激在步法训练过程中适当的时间通过SBA仪器的感应器启动肌肉刺激。
2)站立：脊髓损伤或其他瘫痪的病人可通过电激大腿的肢四头肌辅助站立。这些肌肉通过SBA仪器在大腿前部进行电激，由感应器启动，或由病人通过智能手机上的应用程序的按钮启动。上述电激还可帮助病人使用下肢肌肉从床上移动到椅子或其他平面。
3)行走：瘫痪病人或脊髓损伤病人通过电激下肢肌肉和神经辅助简单的行走。电激膝盖以下的腓神经内的感觉神经可引起三种反射，弯曲脚踝、膝盖和胯部以抬起腿，接着刺激肢四头肌可伸展膝盖承受重量。然后在另一条腿上重复这一程序。智能手机上的应用软件操作SBA仪器即可完成这些任务。
上肢
1)手握：电激肌肉恢复因中风或脊髓损伤病人的简单手握动作，以张开手或握紧拳头。SBA仪器应用于前臂的前后部，并通过SBA仪器内的感应器和智能手机内的应用程序实施。
2)伸展：脊髓损伤致瘫的病人有时不能伸展手肘至头部以上。应用SBA仪器于肱三头肌刺激肌肉伸展肘部。SBA仪器内的感应器检测到手臂运动时启动电激，并与智能手机上的应用软件协作。
姿态：躯干肌肉瘫痪的病人即便在轮椅上也难以维持姿态。除非系了座椅带，否则会前倾，一旦前倾，病人不能自主回复到坐直的姿态。采用SBA仪器对腰部肌肉进行电激可辅助病人保持及回复到坐直的姿态。SBA仪器内的感应器在检测到姿态变化时启动电激。
咳嗽：腹肌瘫痪的病人不能做出有力的咳嗽，有导致肺炎的风险。采用SBA仪器对腹肌进行电激可帮助实现更有力的咳嗽并防止胸部感染。病人通过SBA仪器的感应器启动电激。
特发性震颤：如前所述，神经刺激可减轻或消除特发性震颤的症状。采用TNSS系统可控制特发性震颤。当SBA仪器内的感应器检测到震颤时，其启动针对震颤相关的肌肉和感觉神经的进行适当的频率和震颤相位关系的电激。通常电激的频率与震颤频率相同，但为了取消震颤或重新设置手部位置的神经控制系统电激的相位会移动。
非医疗应用
运动训练
感应身体各部分的位置和方向用来在智能手机上提供视觉反馈，例如，高尔夫球的挥杆，同时提供在挥杆过程的特殊时间点的机械或电反馈，以帮助使用者改正动作。一个或多个SBA仪器可记录肌电图以用于更详细的分析。
电子竞赛
感应手臂、大腿和身体其他部位的位置提供玩家在屏幕上的图像，并与互联网上任何地方的其他玩家互动。通过身体上各部位的SBA仪器内的感应器为玩家提供触觉反馈，如踢球等的感觉。
电影及动画的运动捕捉
无线TNSS捕捉身体多部位的位置、加速和方向。这些数据可用作人类或哺乳动物的动画制作及人类动作要素的分析和设计的应用。
操作模式的示例
一个SBA系统包括至少一个单独的控制器和一个单独的SBA仪器。在将SBA仪器应用于使用者皮肤后，使用者利用近场通讯通过控制器的应用软件控制所述仪器。应用软件出现在智能手机屏幕上，并由使用者以触碰控制；对于钥匙链型控制器，SBA仪器通过按压钥匙链上的按钮控制。
当使用者感觉需要启动SBA仪器时，其按下“启动”按钮两次以上，以防止错误启动，从而启动神经刺激。神经刺激可以多种频率、持续时间及强度进行，直到使用者按下停止按钮，也可以根据应用软件设定的时间长度进行。
TNSS系统内的感应器能用于启动采集/分析数据并在启动时与控制器进行通讯。
协议应用软件的功能水平和内嵌于TNSS的协议根据神经调节或实施的神经刺激范围而定。
在有些情况下将采用多个神经调节或神经刺激的TNSS系统。每个TNSS的基本启动原理相同。
然而，一时启动，多个TNSS系统将自动形成一个神经调节/刺激点的网络，并通过控制器进行通讯。
需要多个TNSS系统的原因是治疗计划可能需要对几个点的刺激才有效果。
尽管本说明书内描述的系统和方法表现了本发明的各个方面，本领域内的技术人中应该可以理解到本发明并不限于所述的实施例。本领域内的技术人员，尤其是在受到本说明书教导的启示下，可以实施修改。例如，所述实施例的每个特征可独立实施，或与其他实施例的特征组合实施。另外，还应理解到在不离开本发明的精神和范围的前提下可实施其他修改。因此本说明书应视为以描述为目的，而非限制。
Claims (10)
1.一种局部神经刺激仪系统，其特征在于，包括：
一个可塑的适应于皮肤的粘块，所述粘块限定表面；
一个或多个电极，所述一个或多个电极安置在邻近所述表面的所述粘块上；
电子电路，所述电子电路嵌入在所述粘块中，所述电子电路包括：
一个被配置为电启动所述一个或多个电极的电信号发生器；
一个与所述电信号发生器通信的信号接收器；
一个与所述电信号发生器电通信的电源；
一个与所述信号接收器通信的电信号启动装置；以及
所述粘块上的反馈感应器，设计用来感应肌肉和/或神经反应，并将数据传送给电信号启动装置；
其中同样的一个或多个电极能够通过在电子电路和反馈感应器之间切换所述一个或多个电极的连接而被交替地用于刺激和感应两者。
2.根据权利要求1所述的局部神经刺激仪系统，所述表面包括粘带。
3.根据权利要求1所述的局部神经刺激仪系统，所述电信号启动装置与所述信号接收器之间的通信是无线的。
4.根据权利要求1所述的局部神经刺激仪系统，所述电信号启动装置包括一个控制器，被配置为使得使用者手动启动电信号发生器。
5.根据权利要求1所述的局部神经刺激仪系统，其包括一个以上的皮肤粘块。
6.根据权利要求1所述的局部神经刺激仪系统，其还包括集成电路，所述集成电路包括信号发生器和信号接收器。
7.一个局部神经刺激粘块，其特征在于，包括：
一个可塑的适应于皮肤的粘块，所述粘块限定表面；
一个或多个电极，所述一个或多个电极安置在邻近所述表面的所述粘块上；
电子电路，所述电子电路嵌入在所述粘块中，所述电子电路包括：
一个被配置为响应于信号启动器来启动所述一个或多个电极的电信号发生器；
一个与电信号发生器及信号启动器连接的天线，以及所述天线被配置为与遥控启动装置通信；
一个与电信号发生器、天线及信号启动器连接的电源；以及
一个神经刺激感应器；以及
一个反馈感应器，用来感应使用者在进行神经刺激后的肌肉反应；
其中同样的一个或多个电极能够通过在电子电路和反馈感应器之间切换所述一个或多个电极的连接而被交替地用于刺激和感应两者。
8.根据权利要求7所述的局部神经刺激粘块，所述粘块的表面包括粘带。
9.根据权利要求7所述的局部神经刺激粘块，所述天线设计用来将肌肉反应数据传送给遥控启动装置。
10.一个局部神经刺激仪系统，其特征在于，包括：
一个带有一个或多个电极及集成电路的可塑的皮肤粘块，所述集成电路包括：
一个信号发生器；
一个启动信号发生器的信号接收器；
一个信号发生器的电源；
一个信号启动装置，所述信号启动装置用于启动所述一个或多个电极；
一个神经反馈感应器；以及
其中同样的一个或多个电极能够通过在信号发生器和神经反馈感应器之间切换所述一个或多个电极的连接而被交替地用于刺激和感应两者。
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