CN101252969A - 神经刺激系统和方法 - Google Patents

神经刺激系统和方法 Download PDF

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CN101252969A
CN101252969A CNA2006800201767A CN200680020176A CN101252969A CN 101252969 A CN101252969 A CN 101252969A CN A2006800201767 A CNA2006800201767 A CN A2006800201767A CN 200680020176 A CN200680020176 A CN 200680020176A CN 101252969 A CN101252969 A CN 101252969A
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waveform
nerve
nerve stimulation
stimulation apparatus
mammal
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M·R·特蕾西
A·迪乌巴尔迪
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Johnson and Johnson Medical SAS
Ethicon Inc
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Abstract

一种用于刺激神经的系统和方法，其中所述系统包括第一波形发生器，适于产生具有能够刺激哺乳动物预定神经的频率的第一波形，第二波形发生器，适于产生具有能够通过哺乳动物组织的频率的载波波形，电连接第一和第二波形发生器并适于调制第一和载波波形以产生调制波形的调制设备，以及电连接所述调制设备并充分接近哺乳动物皮肤进行定位且适于将调制波形应用其上的电极。

Description

神经刺激系统和方法
交叉参考相关申请
本申请是2005年1月26日提交的共同悬而未决的美国专利申请系列号为11/043830的部分延续，而该美国专利申请系列要求2004年2月11日提交的美国专利申请系列号为60/543722的优先权。
技术领域
本发明通常涉及刺激体内神经的设备和方法，并且更特别的涉及刺激阴部神经的设备和方法。
背景技术
妇女占超过1千1百万的失禁病例。一种类型的失禁是压迫性尿失禁(SUI)，其中妇女在正常的日常行为活动，诸如大笑、咳嗽、打喷嚏和常规锻炼期间会经历无意识的尿液遗失。将阴道壁与骨盆肌和耻骨连接的组织或韧带的功能性缺损可引起SUI。一般的原因包括骨盆肌的反复性扭伤、分娩、骨盆肌紧张和雌激素缺失。这种缺损导致不正确的机能性尿道。不像其他类型的失禁，SUI不是膀胱的问题。
其中压迫性失禁典型地为解剖结构的缺损，另一种类型的失禁，急迫性失禁表现出基于神经的并且通常呈现逼尿肌不稳定或“膀胱痉挛”。同样地它通常不益于手术校正。急迫性失禁会或不会导致尿液泄漏，但这两种状况在其他方面都具有相似的症状和相似的治疗方式，该治疗方式通常包括行为修正(降低尿液敏感的经验策略、按计划排泄，避免诸如咖啡因的膀胱刺激物质，以及具有或不具有生物反馈的骨盆肌锻炼)和药物治疗(典型的抗反副交感神经制剂，诸如奥昔布宁或托特罗定)的结合。这些治疗需要终身医治。不幸的是，行为修正需要持续地努力来维持结果并且现有的药物对很多患者具有明显的副作用，造成80％的患者在一年内中断医治。备选的治疗是改变生活方式来适应这种情况-频繁地排尿以避免“意外”发生，并根据情况的严重性穿戴保护性衬垫或内衣。
用于治疗的另一种方法是骶骨和/或阴部神经的刺激。骶椎神经根分成多对，横向贯穿于神经根孔中。这些根的主要目的地是骶神经丛。来自该丛的多个神经提供下肢和骨盆各器官的运动和感觉神经支配。具体的，骶神经丛分成五个骶神经对，骶椎神经(S1到S5)。这些神经供给大腿和腿部靠下部分，脚，多数的生殖器官和肛门周围区域。阴部神经是阴部神经丛的最大束支，并由躯体感觉、躯体运动和源自第二、第三和第四骶神经前主分植的自主成分组成。阴部神经更靠近膀胱，并且它的刺激促使膀胱活动，这样消除或减少了它的收缩。至少一种已知的商业设备通过在骶神经束支中延伸的针来刺激所述骶神经。然而，该设备供应连续的信号以提供神经的恒定刺激。该设备的各种缺点包括它的侵入性本质和对身体其他区域的不希望的刺激效果，因为骶神经作为整体进行刺激并且身体的多个其他区域被这种刺激所趋势(即，导致腿的抽搐等)。
称为Advanced Bionics的公司具有特别以阴部神经而非骶神经为目标的非侵入性刺激设备。该设备插入到阴部神经的附近，也是侵入性的并供应如上所述的恒定信号，从而该设备具有相同的缺点。
因此，需要一种用于刺激阴部神经以治疗失禁的改进设备和方法。
发明内容
本发明提供一种用于哺乳动物的神经刺激设备，其包括适于产生第一波形的第一波形发生器，所述第一波形具有能够刺激所述哺乳动物预定神经的频率；适于产生载波波形的第二波形发生器，所述载波波形具有能够穿过所述哺乳动物组织的频率；电耦合到第一和第二波形发生器并适于调制第一波形和载波波形以产生调制波形的调制设备；以及电耦合到所述调制设备并充分接近所述哺乳动物皮肤进行定位且适于对其应用所述调制波形的电极。
第一和第二波形发生器以及所述电极可定位在其上具有粘合剂的贴片设备内，该粘合剂用于将所述贴片固定到所述皮肤上。在备选实施例中，所述设备进一步包括从与所述电极充分电接触的位置延伸、穿过所述哺乳动物组织内的管道到更靠近所述预定神经位置处的导电凝胶，其可充分地接近所述预定的神经。在又一实施例中，所述预定的神经是阴部神经，并且所述贴片基本定位在所述哺乳动物的腹部或骶骨部区域内。
根据又一实施例，第一波形具有基本在10-40Hz范围内的频率，并且可以是方波。此外，载波波形可具有基本在10-400kHz范围内的频率，并且可以是正弦波形。
在备选实施例中，所述神经刺激设备进一步包括适于控制第一和第二载波波形发生器产生第一波形和载波波形的微处理器。它还进一步包括适于无线接收生物反馈数据的接收设备，其中所述接收设备电耦合到所述微处理器用于给它提供所述生物反馈数据。在又一实施例中，所述设备进一步包括至少一个植入到哺乳动物体内的生物反馈设备，其中所述至少一个生物反馈设备包括至少一个适于感应一个或多个所述哺乳动物体内生理状况的传感器设备。所述生物反馈设备还包括至少一个电耦合到所述传感器设备上的发送设备，并且所述生物反馈设备适于接收来自所述传感器设备的信号并将代表所述信号的生物反馈数据无线发送到哺乳动物体外的点。在又一实施例中，所述生物反馈数据经由所述接收器设备发送给所述微处理器，并且所述微处理器至少部分基于所述生物反馈数据来控制第一和第二波形发生器。在不同的实施例中，所述生物反馈数据可表示膀胱压力和/或腹部压力。
本发明还提供了一种用于刺激哺乳动物预定神经的方法，包括产生具有能够刺激所述预定神经的频率的第一波形，产生具有能够穿过所述哺乳动物组织的频率的第二波形，调制第一波形与载波波形以产生调制信号，并将该调制信号施加到所述哺乳动物的皮肤上。
所述方法进一步包括将至少一个传感器植入到所述哺乳动物体内，利用所植入的传感器感应一个或多个所述体内的生理属性，无线发送表示所感应的生理属性的生物反馈数据，并利用所述生物反馈数据来控制第一和第二波形发生器产生第一和载波波形。
还提供了一种神经刺激设备，其包括适于产生具有频率基本在10-40Hz范围内的第一波形的第一波形发生器，适于产生具有频率基本在10-400kHz范围内的载波波形的第二波形发生器，电耦合到第一和第二波形发生器以调制第一和载波波形从而产生调制波形的调制设备，以及电耦合到所述调制设备并定位在充分靠近哺乳动物的皮肤处用于将所述调制波形施加到所述哺乳动物皮肤上的电极。
当结合作为示例阐述了本发明原理的伴随性附图，从下面更详细的描述中，本发明的这些和其他特征和优势将变得很显然。
附图说明
图1是根据本发明一个实施例的经皮发送设备的示意性说明；
图2示出了由图1的设备所产生的代表性波形；
图3是进一步结合生物反馈机制的图1设备的示意性说明；
图4示出了可与图3的设备结合使用的代表性植入传感器设备；
图5a示出了在可膨胀笼中的图4传感器设备处于其非膨胀状态；
图5a示出了在可膨胀笼中处于其非膨胀状态的图4传感器设备；
图5b示出了在可膨胀笼中处于其膨胀状态的图4传感器设备；
图6示出了可植入传感器设备的备选实施例；
图7a-7c示出了图5a和5b的可植入传感器设备的各种布置步骤；
图8示出了布置在所述膀胱中图5a和5b的可植入传感器设备并具有伸入到尿道中的尾部；
图9示出了可与图3的系统结合使用的第一和第二可植入传感器设备；
图10a示出了可植入传感器设备的备选实施例；和
图10b示出了可植入传感器设备的又一备选实施例。
具体实施方式
在详细解释本发明之前，值得注意的是本发明的应用或使用并不限于它在附图和说明书中阐述的结构和部件安排细节。本发明各阐述性实施例可实施或结合其他实施例、各种变形和修正来实施，并可以各种方式来实践或执行。例如，虽然关于女性的神经刺激详细描述了本发明，但是可以理解的是它也适用于男性。此外，在此公开的本发明的原理、设备和方法还具有刺激各种其他神经的应用，诸如在分娩期间的神经刺激。另外，在此描述的技术可用于有助于或影响下面的状态的神经系统的各种组成：压迫性尿路失禁、肛门和大便失禁、性功能紊乱、间质性膀胱炎、慢性疼痛诸如但不限于骨盆疼痛和遗尿症。
在此描述的本发明一个独特方面是刺激阴部神经的方式，它是经皮而非经由针或其他侵入性元件靠近所述神经周围插入身体内部。这种方式的显见优点是不仅患者舒适，而且还消除了误伤害其他神经或管的手术风险。所述系统提供直接，但优选地选择性对阴部神经进行刺激，其部分地基于与体内感应的生理状况(诸如膀胱收缩)相对应的生物反馈数据进行控制。
如上所述，已知的是表面电极可用于刺激体内的神经和肌肉。然而遇到的一个问题是所施加的电信号趋于广泛地扩散，除目标肌肉和神经外，还对非目标肌肉和神经产生影响，这常常是不希望的。此外，为了解决这一信号耗散，所施加的电流水平必须显著地增大以确保在目标位置上的足够电流强度。与电信号经皮应用相关的另一挑战是，由由大约10-40Hz的低频率信号刺激所述阴部神经。然而，这种低频信号本身不能穿过身体组织，并且因此对直接经皮应用是不能传导的。很多这些挑战已经被本发明所克服，下面将详细对其进行描述。
图1示意性示出了根据本发明的代表性经皮信号发送(transmission)设备100。所述信号发送器优选含于可拆卸地固定到皮肤(优选在患者的下腹部区域或者下骶骨处)表面上的经皮贴片(patch)101等中。这种贴片可以是任何合适的粘性绷带或类似物。
信号发送器100包括合适的电源102，诸如Minnesota的Elk RiverCYMBETTM Corp.的型号为CPF141490L的锂离子薄膜电池，以及电连接到所述电池并由其供电的第一104和第二106波形发生器。这些波形发生器可以是任何的类型，诸如由Dallas的Texas的Texas Instruments出售的型号为NE555的类型。第一波形发生器104产生第一波形或信号，其具有已知的能刺激体内神经(包括阴部神经)的频率，该频率近似在10-30Hz的范围内。如上所指示的，这种施加到皮肤上的低频信号，其本身不能穿过身体组织到达阴部神经来以足够的电流强度刺激所述神经。由此，提供第二波形发生器106来产生载波波形，其与第一波形一起施加到调幅器108，诸如Texas Instruments的On-Semi MC1496调制器。第一波形优选是频率近似10-40Hz的方波，而第二波形优选是频率在10-400kHz范围内的正弦信号。如本领域的技术人员将会意识到的，这种第一波形202与第二波形(载波)204的调制导致了具有通常如图2所示结构的调制波形或信号206。
将调制信号206提供给适当的表面电极110，诸如来自Hixson，TN的Chattanooga Group，Inc.的DURA-STICK自粘性电极，它直接给皮肤施加调制的波形。如本领域的技术人员易于理解的，由于第一波形的高频特性，调制信号的使用能够使所述波形穿透组织，而且由于所述调制信号的低频包络，它被所述阴部神经所觉察(或响应)。
在一个实施例中，刺激能量从表面电极到目标神经的传导可以通过放置传导束(conductive tract)增加，该传导束完全地或者部分地从表面电极延伸到目标神经。所述传导束可以是交联的聚丙烯酰胺凝胶，诸如来自Denmark的Contura的
Figure S2006800201767D00061
可注射凝胶。该注射或以其他方式插入的生物注射凝胶是高传导性的，并且可以是水溶液或不是水溶液。所注入的凝胶提供了比诸如金属线或钢电极的刚性植入物更好的益处。一些优势包括易于运送，减少侵入并且由于凝胶不是坚硬的并可顺应患者的身体，使患者感到舒服。如上面所提到的，注射凝胶束(gel tract)的明显优势是从所述表面电极到目标神经的高传导路径比周围组织具有更好的传导性。这减少了能量分散并增加了表面电极与目标神经之间的能量传输效率。
上述信号发送设备优选用于结合了各种生物反馈机制的系统中，以产生治疗急迫性尿失禁(urge incontinence)的闭合环路系统，并且还提供一种系统，其中阴部神经刺激是选择性的，并且仅当必要时才应用，而不像既有事实那样在知道的情况下试图不断地对阴部神经刺激。这种系统进一步包括一个或多个优选植入到体内的传感器设备115。所述传感器设备优选包括至少一个将感应所选生物生理属性的传感器120(图3)，以及将所述传感器收集的数据或信息发送回体外以进行进一步处理的数据发送设备122，这在下面进行更充分描述。
现在参考图3，信号发送器100是更大的信号控制设备300的一部分，更大的信号控制设备300进一步包括接收设备310，诸如来自CA的Sunnyvale的Maxim Semiconductors的MAX 1472，其电耦合到电池102并由它来供电。所述接收设备接收来自所述一个或多个传感器115的数据并将该数据提供给微控制器312或类似物。所述微控制器被编程为接收并分析所述数据，并基于该数据给第一和第二波形发生器104、106提供输入，从而控制信号发送器100的信号发送。例如，生物反馈传感器115可以是如下面详细描述的植入膀胱内的压力传感器。因为测量的随时间的膀胱内压力指示膀胱收缩的存在和幅度，当这种测量指示痉挛性膀胱肌肉活动(与正常膀胱收缩相比，其可导致膀胱内的压力缓慢而稳定的上升)时，反馈信号可发送到接收设备并随后发送到微控制器。基于该信号的接收，所述微控制器将通过波形发生器的控制而引起电极发射调制的信号。阴部神经接收到该信号将促使膀胱肌活动，充分消除痉挛性肌肉收缩。
现在参考图4、5a和5b，更详细地描述了代表性的生物反馈设备115。在优选实施例中，可植入的生物反馈设备115由包括电源402、一个或多个传感器组件404以及电子接口406的多个电子组件组成，它们中的每一个彼此电耦合并以本领域已知的方式机械装配于印刷电路板407上。所述一个或多个传感器组件404感应体内预定的生理属性，并将表示这些属性的信号或数据发送给电接口406。所述系统可包括数据存储元件，用于保存关于所感应的生理属性的数据，而且还包括发送器409，用于将所述数据发射到患者体外，使得其可用于控制如上所述的调制信号的发生。如图5a和5b所示，在一个实施例中生物反馈设备115基本上被可伸缩的外罩510或笼子所环绕。
优选的，所述生物反馈系统(所述外罩除外)的整体尺寸为：直径d大约0.65-10mm，长度l大约0.65-10mm。在优选实施例中，所述传感器组件是微型压阻压力换能器，用于测量患者膀胱内的压力。合适的换能器是来自Schaumburg，III的Motorola的MPX系列的压力传感器。其他合适的组件可包括来自Dallas，TX的Texas Instruments，Inc.的MSP430F149微控制器，其可用于采集、过滤和存储来自所述压力传感器的数据，以及诸如任何合适的生物相容性锂电池的电源。虽然上面已经列举了特定合适的电子组件，但是也存在很多其他的组件并可结合到本发明中。如所指示的，这些电子组件优选装配于印刷电路板上。随后，可将这些组件和电路板覆盖和封装在硅树脂或其他合适的覆盖物中以保护它们不与外界，诸如膀胱内的流体环境接触。
现在再次参考如图5a和5b所示的外罩510。在优选实施例中，所述外罩是由合适的金属(诸如镍钛合金(Nitonol)、不锈钢或钛合金)，或者合适的生物相容性聚合物(诸如聚丙烯或聚对苯二甲酸乙二酯(polyethylene terapthalate)制成的可折叠的笼子。所述可折叠笼子的优势在于它可以以如图5a所示的小到足以通过患者尿道插入的折叠状态存在。然而，一旦插入到膀胱中(如下面进一步所述)，该笼子可呈现如图5b所示的膨胀状态，其尺寸足够大从而不能退回尿道，从而保留在膀胱中直到希望进行物理移动。所述外罩或笼子在没有受到外力压缩时，回到其膨胀状态(图5b)。所述各电子组件和印刷电路板可以任何合适的方式，诸如通过利用生物相容性粘合剂，机械地附着于所述笼子。所述外罩进一步包括从其向外延伸的尾部元件512。该尾部元件512可用作所述设备的发送器以取代如图4所示的发送器结构。如下面将进一步的描述，如果需要，该尾部元件512还可结合额外的传感器元件。
在另一实施例中，所述膨胀的笼子可以由可吸收的材料，诸如来自Somerville，N.J.的Ethicon，Inc.的
Figure S2006800201767D00081
(一种由聚糖乳酸(polyglactin)和polydioxanon制成的可吸收合成复合材料)或可吸收和非可吸收材料的组合，来制成。所述可吸收材料优选在预定时间段后(诸如至少2-3天)溶解，使得可植入设备能用于临时数据采集并在已经采集了足够的数据后以非侵入的方式从身体排出。
作为上述可折叠笼子的备选方案，所述外罩可具有稳定的结构而非可折叠的结构，该结构具有比尿道的直径更小的外径D，以便能穿过尿道插入到膀胱中(见图6)。所述外罩进一步具有一个和多个突起602，诸如螺纹、倒钩等，从该外罩向外延伸，所述突起602能通过推入膀胱的侧壁和驱动到膀胱的侧壁中而附着于膀胱的侧壁。在又一备选实施例中，可植入设备可以缝合到膀胱壁，或利用合适的生物相容性粘合剂粘附于膀胱壁。
为了植入设备115，压缩外罩510并如图7a所示将其装载到单腔或多腔导管700中，该导管通过尿道702进行插入，直到尖端或远端703位于膀胱704中。所述导管可以是任何用于输尿管应用的合适导管，诸如Foley导管。荧光、超声或本领域技术人员已知的其他类似技术可用来帮助将所述可植入的系统传送和定位在膀胱中。如果使用多腔导管，则其他的腔室可用于对膀胱进行填充和排泄、传送药物、提供可视化的访问，或在放置所述可植入系统的同时监视压力。将推出元件706(诸如推杆等)插入到所述设备或外罩后面的初级腔室，并且一旦所述导管的远端恰当地定位在膀胱中，则在如图7b和7c所示箭头的方向上朝着所述导管的远端移动所述推出元件，从而所述设备和外罩从所述导管的远端推出并进入到膀胱中。当可植入的系统从所述导管中出来时，可折叠笼子510不再保持其折叠状态，并进行膨胀到它完全膨胀的状态。虽然描述了导管的使用，其他合适的植入方法同样也可使用，诸如经由膀胱镜或类似手术工具的工作通道进行放置，或者经由腹腔镜或者打开式外科手术放置。一旦展开在膀胱中，调节该可膨胀笼子的尺寸以防止所述设备安置在膀胱颈或以其他方式进入尿道，并进一步允许尿液自由流过该设备。图8示出了在膀胱704内完全展开的所述设备。
如上所述，不应用可膨胀笼子的备选实施例也是合适的，诸如图6所示。植入这种设备的方法类似于上述方法，所述导管中的推出元件用于驱使所述突起元件602进入到膀胱壁中，从而将所述设备锚定在膀胱中。
为了本发明的目的，设备115优选保留在膀胱中一定长时间以提供恒定的反馈用来控制所述电极的操作。当不使用恒定的反馈(即，图1)时，此处描述的可植入传感器仍然可以用来获得用于实现精确诊断和/或适当治疗的数据。例如，所述设备可保留在膀胱中1-2天，每1/2秒进行膀胱压力的测量。随后对膀胱压力改变的类型和频率进行分析以提供评估泌尿功能的反馈。例如，随时间测量的泡囊压力可揭示排空的次数和频率。在一个实施例中，(各)传感器元件设计用来以长期的睡眠模式进行工作，在固定的时间间隔“醒来”以测量压力等。一旦已经收集了足够的数据，所述设备随后可通过下述方式从膀胱中移走：将导管插入到膀胱中以取回所述可植入设备，或使用膀胱镜的工作通道或其他适合仪器取回所述设备。所述导管或膀胱镜将插入到膀胱中，并且所述设备被抓紧并拽回到导管或膀胱镜通道中并随后从体内撤出。
在这些情况下，该生物反馈设备除了或代替发送器还可结合用来存储而非发射所述数据的数据存储设备408(图4)。所述数据随后可被取回并优选以任何合适的方式将所述数据上载到基于PC的软件应用程序而被处理，所述任何合适的方式例如是无线方式，如经由与微处理器接口的红外数据采集单元(如ENDEC HSDL-7001和IrDA收发器HSDL-3202)，经由射频采集，或经由诸如通过RS232接口的硬件连线连接。
再次参考图3，其中利用生物反馈数据，接收器310可接收来自不止一个生物反馈设备115的反馈数据。在图9所示的一个实施例中，第二可植入传感器设备902类似于结合图4显示和描述的设备，设计用于插入到患者的阴道腔内，从而优选封装在如图所示的“类似棉球”的设备或罩壳内。该罩壳912优选简单地卷起或束缚棉花，类似于棉球。由于以第二可植入设备感应腹部压力，和第一可植入感应感应膀胱压力，逼尿肌压力(膀胱壁组织的肌肉内衬压力)可通过从腹部压力中减去膀胱压力进行确定。如果患者紧张、咳嗽、打喷嚏、大笑等会发生逼尿肌压力升高，并且这些压力的检测在诊断各种膀胱和下尿路疾病状态中具有临床意义。例如，逼尿肌压力增加的频率为评估急迫性尿失禁提供了有意义的数据。
在备选实施例中，两个可植入设备中的一个给另一个发送数据，它然后再将两组数据无线发送给接收器310。
在又一实施例中，膀胱内的第一植入设备包括一个和多个附加的传感器950，它们可结合到一个和多个尾部元件中，如图10和10a所示。在一个特定的应用中，(各)传感器是结合到尾部的检漏传感器，该尾部设计用来如图8所示在膀胱内从所述设备延伸，穿过括约肌进入到尿道702中。所述(各)传感器检测流体是否存在，并从而检测诸如发生在压迫性失禁患者中的尿泄漏，同时膀胱内的所述压力传感器测量膀胱压力。这样，通过将膀胱压力上升的时间与同时经过尿道的流体泄漏的检测相关联来记录压迫性失禁事件。
此外，可将多个尾部元件950a、950b、950c如图10a所示结合到多个传感器元件952a、952b、952c以便记录膀胱内不同点的压力，从而提供更精确的读数。
从上述可以意识到，虽然已经阐述和描述了本发明的各个特定形式，，但是在不脱离本发明精神和范围内可进行各种修改。因此，除了所附权利要求外，并非对本发明的限定。

Claims (41)

1、一种用在哺乳动物中的神经刺激设备，包括：
适于产生第一波形的第一波形发生器，所述第一波形具有能够刺激所述哺乳动物的预定神经的频率；
适于产生载波波形的第二波形发生器，所述载波波形具有能够穿过所述哺乳动物的组织的频率；
电耦合到第一和第二波形发生器并适于调制第一波形和载波波形以产生调制波形的调制设备；以及
电耦合到所述调制设备并充分接近所述哺乳动物的皮肤进行定位且适于对其应用所述调制波形的电极。
2、根据权利要求1的神经刺激设备，其中第一和第二波形发生器以及所述电极定位在其上具有粘合剂的贴片设备内，该粘合剂用于将所述贴片固定到所述皮肤上。
3、根据权利要求1的神经刺激设备，进一步包括导电凝胶，该导电凝胶从与所述电极充分电接触的位置延伸，穿过所述哺乳动物组织的管道到更靠近所述预定神经的位置处。
4、根据权利要求3的神经刺激设备，其中所述导电凝胶延伸到充分靠近所述预定神经的哺乳动物体内的位置。
5、根据权利要求1的神经刺激设备，其中所述预定的神经是阴部神经，并且所述贴片基本定位在所述哺乳动物身体的腹部或骶骨部区域。
6、根据权利要求1的神经刺激设备，其中第一波形具有基本在10-40Hz范围内的频率。
7、根据权利要求6的神经刺激设备，其中第一波形是方波。
8、根据权利要求7的神经刺激设备，其中载波波形具有基本在10-400kHz范围内的频率。
9、根据权利要求8的神经刺激设备，其中载波波形是正弦波形。
10、根据权利要求1的神经刺激设备，进一步包括适于控制由第一和第二波形发生器产生第一波形和载波波形的微处理器。
11、根据权利要求10的神经刺激设备，进一步包括适于无线接收生物反馈数据的接收设备，所述接收设备电耦合到所述微处理器以为其提供生物反馈数据。
12、根据权利要求11的神经刺激设备，进一步包括至少一个植入到哺乳动物体内的生物反馈设备，所述至少一个生物反馈设备包括至少一个适于感应一个或多个所述哺乳动物体内生理状况的传感器设备。
13、根据权利要求12的神经刺激设备，所述生物反馈设备还包括至少一个电耦合到所述传感器设备的发送设备，并且所述生物反馈设备适于接收来自所述传感器设备的信号并将代表所述信号的生物反馈数据无线发送到哺乳动物体外的点。
14、根据权利要求13的神经刺激设备，其中所述生物反馈数据经由所述接收器设备发送给所述微处理器，并且所述微处理器至少部分地基于所述生物反馈数据来控制第一和第二波形发生器。
15、根据权利要求13的神经刺激设备，其中所述生物反馈数据代表膀胱压力。
16、根据权利要求13的神经刺激设备，其中所述生物反馈数据代表腹部压力。
17、一种用于刺激哺乳动物的预定神经的方法，包括：
产生具有能够刺激所述预定神经的频率的第一波形；
产生具有能够穿过所述哺乳动物的组织的频率的载波波形；
将所述第一波形与所述载波波形进行调制以产生调制信号；
将该调制信号施加到所述哺乳动物的皮肤。
18、根据权利要求17的方法，其中所述调制信号施加到哺乳动物身体的腹部或骶骨区域的哺乳动物皮肤上。
19、根据权利要求17的方法，其中第一波形具有基本在10-40Hz范围内的频率，载波波形具有基本在10-400kHz范围内的频率。
20、根据权利要求19的方法，其中第一波形是方波。
21、根据权利要求20的方法，其中载波波形是正弦波形。
22、根据权利要求17的方法，进一步包括：
将至少一个传感器植入到所述哺乳动物体内；
利用所植入的传感器感应一个或多个所述体内的生理属性；
无线发射表示所感应的生理属性的生物反馈数据；和
利用所述生物反馈数据来控制第一和第二波形发生器产生第一波形和载波波形。
23、根据权利要求22的方法，其中所述生物反馈数据发送给微处理器，该微处理器电耦合到并控制第一和第二波形发生器。
24、根据权利要求17的方法，进一步包括这样的步骤，在所述施加步骤之前，将导电凝胶注入哺乳动物体内的管道中，所述管道从基本在哺乳动物皮肤表面的第一端延伸到位置更接近预定神经的第二端，其中所述施加步骤进一步包含将所述调制波形施加到基本与所述管道第一端内的导电凝胶电接触的位置。
25、根据权利要求24的方法，其中所述管道的第二端的位置充分靠近所述预定的神经，并且其中所述导电凝胶基本上填充所述管道。
26、根据权利要求25的方法，其中所述预定神经是阴部神经。
27、一种神经刺激设备包括：
适于产生频率基本在10-40Hz范围内的第一波形的第一波形发生器；
适于产生频率基本在10-400kHz范围内的载波波形的第二波形发生器；
电耦合到第一和第二波形发生器的调制设备，用于调制第一波形和载波波形从而产生调制波形；以及
电耦合到所述调制设备并定位成充分靠近哺乳动物的皮肤的电极，用于将所述调制波形施加到所述哺乳动物皮肤上。
28、根据权利要求27的神经刺激设备，其中第一和第二波形发生器和调制设备定位在贴片内，该贴片具有用来将该贴片固定到所述皮肤上的粘性表面。
29、根据权利要求27的神经刺激设备，其中第一波形是方波。
30、根据权利要求29的神经刺激设备，其中载波波形是正弦波形。
31、根据权利要求27的神经刺激设备，进一步包含：
电耦合到第一和第二波形发生器的微处理器；和
接收器设备，其电耦合到所述微处理器并适于接收所发射的生物反馈数据并将所述生物反馈数据提供给所述微处理器。
32、根据权利要求31的神经刺激设备，进一步包含：
至少一个植入哺乳动物体内的生物反馈设备，所述生物反馈设备包括至少一个适于感应哺乳动物体内一个或多个生理属性的传感器；和至少一个电耦合到所述传感器并适于接收表示所感应的生理属性的信号和将表示所感应的生理属性的生物反馈数据发送到第二位置的发送器。
33、一种选择性刺激哺乳动物预定身体部分的经皮刺激设备，包含：
适于产生第一波形的第一波形发生器，所述第一波形具有选择成刺激所述预定身体部分的频率；
适于产生第二载波波形的第二波形发生器，所述第二载波波形具有能够穿过所述哺乳动物的皮肤和组织以到达所述预定身体部分的频率；
电耦合到第一和第二载波波形发生器并适于调制第一波形和第二载波波形以产生调制波形的调制设备；
电耦合到所述调制设备并充分接近所述哺乳动物皮肤定位的激活电极，所述激活电极适于将所述调制波形施加到所述皮肤上；和
充分接近所述哺乳动物皮肤进行定位并适于接收由所述激活电极施加的调制波形的返回电极，
其中所述激活电极和返回电极相对于彼此进行定位，使得至少一部分所施加的调制波形可从所述激活电极传到所述返回电极，而基本上不穿过所述哺乳动物的组织。
34、根据权利要求33的设备，其中所述激活电极和返回电极包含在能够固定到哺乳动物皮肤上的贴片内。
35、根据权利要求33的设备，其中所述预定身体部分是神经，或是神经的一部分。
36、根据权利要求35的设备，其中所述预定身体部分是阴部神经。
37、一种选择性刺激哺乳动物的预定身体部分的方法，包含：
提供经皮刺激设备，其具有第一波形发生器，适于产生具有选择成刺激预定身体部分的频率的第一波形；第二波形发生器，适于产生具有能穿过哺乳动物皮肤和组织到达预定身体部分的频率的第二载波波形；电耦合到第一和第二载波波形发生器并适于调制第一波形和第二载波波形以产生调制波形的调制设备；电耦合到所述调制设备并充分接近哺乳动物皮肤进行定位的激活电极，所述激活电极适于将所述调制波形施加到所述皮肤上；以及返回电极，其充分接近哺乳动物皮肤进行定位并适于接收由所述激活电极施加的调制波形；
将激活电极和返回电极充分接近哺乳动物皮肤并相对于彼此进行定位，使得至少一部分所施加的调制波形可从激活电极传到返回电极，而基本上不穿过哺乳动物的组织；和
经由所述激活电极给哺乳动物的皮肤施加所述调制波形以刺激所述预定身体部分。
38、根据权利要求37的方法，其中所述激活电极和返回电极包含在贴片内。
39、根据权利要求38的方法，其中所述定位步骤进一步包含将所述贴片基本上放置在哺乳动物的腹部或骶骨区域中。
40、根据权利要求37的方法，其中所述预定身体部分是神经，或神经的一部分。
41、根据权利要求40的方法，其中所述预定身体部分是阴部神经。
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CN109010008A (zh) * 2018-08-22 2018-12-18 深圳瑞格美科技有限公司 神经肌肉电刺激方法、神经肌肉电刺激器及其主机

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