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CN106669030A - 电流施用的最佳化 - Google Patents

电流施用的最佳化 Download PDF

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CN106669030A
CN106669030A CN201610957461.7A CN201610957461A CN106669030A CN 106669030 A CN106669030 A CN 106669030A CN 201610957461 A CN201610957461 A CN 201610957461A CN 106669030 A CN106669030 A CN 106669030A
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blocking
stimulating
circuit
current
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CN106669030B (zh
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葛·奥伦
巴尔·伊坦
艾伦·本杰明
安顿·普洛克金
佑希·葛洛斯
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Qingfeng Medical Co Ltd
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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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Abstract

本发明提供一种装置，包括：(a)一可植入的刺激单元，配置成通过施加一刺激电流以诱发一对象的一神经中的多个动作电位；(b)一可植入的阻断单元，配置成通过施加一阻断电流以阻断所述多个动作电位；以及(c)一体外控制器，包括：一电路，配置成：(1)无线地驱动所述刺激单元以施加所述刺激电流，(2)在一第一模式中，无线地驱动所述阻断单元以施加所述阻断电流，同时不驱动所述刺激单元施加所述刺激电流，(3)在一第二模式中，无线地驱动所述阻断单元以施加所述阻断电流，同时驱动所述刺激单元以施加所述刺激电流，以及(4)当所述体外控制器处于所述第二模式时，根据执行的感测，无线地改变所述阻断电流的一参数。

Description

电流施用的最佳化
相关申请案
本专利申请案主张于2015年11月9日由奥伦(Oron)等人提交的美国申请案14/935,941的优先权，标题为“电流施用的最佳化(Optimization of application ofcurrent)”，其通过引用并入本文。
本申请案涉及以下多个申请案，所有这些申请案转让给本申请案的受让人，并且所有这些申请案通过引用并入本文：
授予葛洛斯(Gross)等人的美国专利申请案14/374,375，标题为“多种无线神经刺激器(Wireless neurostimulators)”，其公开为美国专利公开号US2015/0018728；
于2015年1月21日由奥伦(Oron)等人提交的美国专利申请案14/601,626，标题为“多种体外植入物控制器(Extracorporeal implant controllers)”，其公开为美国专利公开号US2016/0206890；以及
授予于2015年1月21日由普洛克金(Plotkin)等人提交的美国专利申请案14/601,568，标题为“多种用于神经刺激的传输线圈(Transmitting coils forneurostimulation)”，其公开为美国专利公开号US2010/0206889。
技术领域
本发明的一些应用一般涉及多种医疗装置。更具体地而言，本发明的一些应用涉及多种经皮的(percutaneous)神经刺激器植入物。
背景技术
神经刺激是用于治疗各种神经障碍的一临床工具。这种技术涉及通过电激活身体中的纤维来调节神经系统。经皮植入物的存在用于提供神经刺激。提供这种植入物电源是一种技术挑战。
发明内容
本文所述的系统包括一阻断单元，配置用以阻断多个不想要的内源动作电位，通常是多个传入的(afferent)动作电位，导致不愉快或痛苦的感觉(例如由于神经疾病neuropathy)的。
神经阻断装置的校准是有用的，因为有效阻断多个动作电位所需的阻断电流的参数可能在多个个体对象自身之间不同，且/或由于装置的位置和方向的差异，例如相对所述目标神经。此外，对于包括一植入物的装置，所述植入物的移动(例如长期迁移或由于所述对象的运动所导致的短期移动)也可能影响所述阻断电流的多个最佳参数。
本文描述的几种技术涉及校准所述神经阻断装置，由多个人工诱发的动作电位协助，从而克服上述问题。对于一些这些技术，所述人工诱发的多个动作电位由一传感器单元检测，并且自动校准。对于一些技术，所述校准是手动的。对于本发明的一些应用，仅在治疗之前进行校准(例如被医生)。对于本发明的一些应用，定期进行校准(例如每周、每天或每小时几次)。
根据本发明的一应用，进一步提供一种使用于一对象的一神经的装置，所述装置包括：
一可植入的刺激单元，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；
一可植入的阻断单元，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；以及
一体外控制器，包括(1)至少一天线，和(2)一电路，配置成：
无线地驱动所述刺激单元以施加所述刺激电流，
在所述体外控制器的一第一模式中，无线地驱动所述阻断单元以施加所
述阻断电流，同时不驱动所述刺激单元施加所述刺激电流，
在所述体外控制器的一第二模式中，无线地驱动所述阻断单元以施加所
述阻断电流，同时驱动所述刺激单元以施加所述刺激电流，以及
当所述体外控制器处于所述第二模式时，根据执行的感测，无线地改变
所述阻断电流的一参数。
在一应用中，所述电路被配置成在所述第一模式和所述第二模式之间自动地周期性地切换所述体外控制器。
在一应用中，所述装置进一步包括一植入物，所述植入物包括一壳体以容置所述刺激单元和所述阻断单元。
在一应用中，所述电路配置成在所述体外控制器的一第三模式中，无线地驱动所述刺激单元以施加所述刺激电流，同时不驱动所述阻断单元施加所述阻断电流。
在一应用中，所述刺激电流具有2至400Hz的一频率，并且所述电路配置成无线地驱动所述刺激单元以施加具有2至400Hz的所述频率的所述刺激电流。
在一应用中，所述刺激电流具5至100Hz的一频率，并且所述电路配置成无线地驱动所述刺激单元以施加具有5至100Hz的所述频率的所述刺激电流。
在一应用中，所述阻断电流具有1至20Hz的一频率，并且所述电路配置成无线地驱动所述阻断单元以施加具有1至20Hz的所述频率的所述阻断电流。
在一应用中，所述阻断电流具有3至10Hz的一频率，并且所述电路配置成无线地驱动所述阻断单元以施加具有3至10Hz的所述频率的所述阻断电流。
在一应用中，所述装置还包括一可植入的传感器单元，配置用以检测所述神经中的所述被诱发的多个动作电位，并对应性地提供一传感器信号，所述传感器信号传达关于所述被检测到的被诱发的多个动作电位的信息，以及其中所述体外控制器的所述电路配置用以无线地接收所述传感器信号，并且因应于所述接收的传感器信号而改变所述阻断电流的所述参数。
在一应用中，所述装置还包括一植入物，所述植入物包括一壳体以容置所述刺激单元、所述阻断单元和所述传感器单元。
在一应用中，所述电路被配置用以自动地周期性地运行一校准程序，所述校准程序包括：
(a)将所述体外控制器切换至所述第二模式，
(b)接收所述传感器信号，所述传感器信号传达关于当所述体外控制器处于所述第二模式中时所检测到的被诱发的多个动作电位的信息，
(c)因应于在所述校准程序的步骤(b)中所接收到的所述传感器信号，改变所述阻断电流的所述参数，以及
(d)将所述体外控制器切换至所述第一模式。
在一应用中，所述电路被配置成在所述体外控制器的一第三模式中，无线地驱动所述刺激单元以施加所述刺激电流，同时不驱动所述阻断单元施加所述阻断电流，并且其中在步骤(a)之前，所述校准程序还包括：
(1)将所述体外控制器切换为所述第三模式，以及
(2)接收所述传感器信号，所述传感器信号传达当所述体外控制器处于所述第三模式中时所检测到的被诱发的多个动作电位的信息。
在一应用中，所述校准程序的步骤(c)包括：因应于在所述校准程序的步骤(b)中接收的所述传感器信号，以及因应于在所述校准程序的步骤(2)中接收的所述传感器信号，改变所述阻塞电流的所述参数。
在一应用中，所述体外控制器进一步包括一使用者接口，并且其中所述电路配置成因应于所述使用者接口的一使用者操作，无线地改变所述阻断电流的所述参数。
在一应用中，所述电路配置成因应于所述使用者接口的一使用者操作，在所述第一模式和所述第二模式之间切换所述体外控制器。
根据本发明的一应用，进一步提供一种使用于一对象的一神经的装置，所述装置包括：
一刺激单元，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；
一可植入的阻断单元，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；
一可植入的传感器单元，配置用以检测所述神经中的所述被诱发的多个动作电位，并对应性地提供一传感器信号，所述传感器信号传达关于所述被检测到的被诱发的多个动作电位的信息，以及
一电路，配置成：
驱动所述刺激单元以施加所述刺激电流，
驱动所述阻断单元以施加所述阻断电流，
当驱动所述阻断单元以施加所述阻断电流时，驱动所述传感器单元以检测所述被诱发的多个动作电位以及提供所述传感器信号，
接收所述传感器信号，以及
因应于所述传感器信号，改变所述阻断电流的一参数。
在一应用中，所述装置进一步包括一体外控制器，所述体外控制器包括一电路，配置用以无线地驱动所述刺激单元、所述阻断单元和所述传感器单元，并无线接收所述传感器信号。
在一应用中，所述传感器信号是一无线传感器信号，并且所述电路配置为无线接收所述传感器信号。
在一应用中，所述电路配置用以无线地驱动所述刺激单元，并无线地驱动所述阻断单元。
在一应用中，所述刺激单元配置成通过施加所述刺激电流来引起感觉异常(paresthesia)。
在一应用中，所述刺激单元配置成通过施加所述刺激电流来引起疼痛。
在一应用中，所述电路被配置用以自动地周期性地运行校准程序，所述校准程序包括：
(a)从(1)一第一模式切换至(2)一第二模式，其中在所述第一模式中，所述电路驱动所述阻断单元以施加所述阻塞电流，同时不驱动所述刺激单元以施加所述刺激电流；及在所述第二模式中，所述电路驱动所述阻断单元以施加所述阻断电流，同时驱动所述刺激单元以施加所述阻断电流；
(b)在所述第二模式中，驱动所述传感器单元以检测所述被诱发的多个动作电位并提供所述传感器信号；
(c)因应于在(b)中接收的所述传感器信号，改变所述阻断电流的所述参数；及
(d)切换回所述第一模式。
在一应用程序中，所述电路配置成：
通过提供具有一能量消耗的一阻断命令信号以驱动所述阻断单元；以及
因应于所述传感器信号传达一信息且所述信息指示检测到的被诱发的多个动作电位的一减少时，减少所述阻断命令信号的所述能量消耗。
在一应用中，所述阻断单元设置在所述刺激单元和所述传感器单元之间。
在一应用中，所述刺激单元是一可植入的刺激单元。
在一应用中，所述刺激电流具有比所述阻断电流低的频率，并且所述电路配置用以驱动所述刺激单元以施加具有所述较低频率的所述刺激电流。
在一应用中，所述刺激电流具有2至400Hz的一频率，并且所述电路配置成驱动所述刺激单元以施加具有2至400Hz的所述频率的所述刺激电流。
在一应用中，所述刺激电流具5至100Hz的一频率，并且所述电路配置成驱动所述刺激单元以施加具有5至100Hz的所述频率的所述刺激电流。
在一应用中，所述阻断电流具有1至20Hz的一频率，并且所述电路配置成驱动所述阻断单元以施加具有1至20Hz的所述频率的所述阻断电流。
在一应用中，所述阻断电流具有3至10Hz的一频率，并且所述电路配置成驱动所述阻断单元以施加具有3至10Hz的所述频率的所述阻断电流。
在一应用中，所述装置还包括一植入物，所述植入物包括所述刺激单元、所述阻断单元和所述传感器单元。
在一应用中，所述装置还包括一体外控制器，所述体外控制器包括所述电路，配置用以无线驱动所述刺激单元、所述阻断单元和所述传感器单元，并无线地接收所述传感器信号。
在一应用中，所述植入物进一步包括所述电路。
在一应用中，所述植入物是可注射的。
在一应用中，所述植入物的一尺寸设计成可注射进入一对象的一硬膜外腔(epidural space)中。
在一应用中，所述植入物配置被植入在所述神经处，使得所述传感器单元设置在一第一神经位置，并且所述阻断单元设置在一第二神经位置，所述第二神经位置在所述第一神经位置的一传出(efferent)方向上。
在一应用中：
所述植入物具有一纵向轴，
所述阻断单元沿着所述纵向轴距所述刺激单元0.5至5厘米，以及
所述传感器单元沿着所述纵向轴距所述阻断单元0.5至5厘米。
根据本发明的一应用，进一步提供一种使用于一对象的一神经的装置，所述装置包括：
一植入物，具有一纵向轴，沿着所述纵向轴可注射进入到所述对像中，并且包括：
一长形壳体，具有包括一第一端的一第一半部和包括一第二端的一第二半部；
至少一感觉异常诱发(paresthesia至inducing)电极，设置在所述壳体的所述第一半部内的一第一位置上；
至少一阻断电极，设置在所述壳体的所述第二半部内的一第二位置上；以及
一电路，具有：
一第一模式，其中所述电路同时驱动(1)所述至少一感觉异常诱发电极，以施加一感觉异常诱发电流，所述感觉异常诱发电流具有2至400Hz的一频率，以及(2)所述至少一阻断电极，以施加一阻断电流，所述阻断电流具有1至20kHz的一频率，以及
一第二模式，其中所述电路(1)驱动所述至少一阻断电极以施加所述阻断电流，但是(2)不驱动所述至少一感觉异常诱发电极施加所述感觉异常感生电流。
根据下面应用的详细描述并结合附图将更充分地理解本发明，其中：
附图说明
图1至图4是根据本发明的一些应用中，使用于一对象的一神经的多个系统的多个示意图；
图5至图10是根据本发明的一些应用中，显示所述多个系统的操作的多个示意图；以及
图11至图12是根据本发明的一些应用中，使用于一对象的一神经的一系统以及所述系统的操作的多个示意图。
具体实施方式
本文所述的系统包括一阻断单元，配置用以阻断多个不想要的内源动作电位，通常是多个传入的(afferent)动作电位，导致不愉快或痛苦的感觉(例如由于神经疾病neuropathy)的。对于一些应用，这是所述系统的主要功能。
神经阻断装置的校准是有用的，因为有效阻断多个动作电位所需的阻断电流的参数可能在多个个体对象自身之间不同，且/或由于装置的位置和方向的差异，例如相对所述目标神经。此外，对于包括一植入物的装置，所述植入物的移动(例如长期迁移或由于所述对象的运动所导致的短期移动)也可能影响所述阻断电流的多个最佳参数。
通常，根据所述对像关于是否已经达到减少令人不愉快/痛苦的感觉的反馈，来执行神经阻断装置的校准。所治疗的感觉通常不是连续的或恒定的，并且可以根据受试者的一天中的时间、位置和/或活动和/或其它因素而波动。这可能使得校准困难。本文描述的几种技术涉及通过人工诱发的多个动作电位来协助校准所述神经阻断装置，从而克服上述问题。
参考图1至图4，其为根据本发明的一些应用中，使用于一对象的一神经的多个系统40、60、80及100的多个示意图。系统40、60、80和100中的各者包括(1)一刺激单元，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；(2)一可植入的阻断单元，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；(3)一可植入的传感器单元，配置用以检测所述被诱发的多个动作电位，以及(4)一电路，特别是配置成驱动所述刺激单元、所述阻断单元以及所述传感器单元。系统40、60、80和100中的各者还包括一体外控制器，对所述刺激单元、所述阻断单元和所述传感器单元无线地提供电源。系统40和60的体外控制器进一步包括所述电路，配置用以驱动所述刺激单元、所述阻断单元和所述传感器单元，而在系统80中，电路是可植入的，并且所述体外控制器仅仅是无线地提供电源。在系统100中，由一植入的电池提供电源，并且没有体外控制器。
所述刺激单元、所述阻断单元和所述传感器单元各自包括一或多个电极，因此各电极配置用以与所述对象电相接。所述刺激单元通过其一或多个电极施加所述刺激电流，所述阻断单元通过其一或多个电极施加所述阻断电流，所述传感器单元通过其一或多个电极检测被诱发的多个动作电位。
一般而言，所述阻断电流具有大于1kHz和/或小于20kHz(例如，1至20kHz、例如1至10kHz、例如3至10kHz)的一频率。
一般而言，刺激电流具有大于2Hz和/或小于400Hz的一频率(例如2至400Hz、例如2至300Hz、例如2至200Hz、例如2至100H、例如5至100Hz、例如5至40Hz)。对于一些应用，所述刺激电流包括更高频率的突发(burst)，例如高达1200Hz。通常刺激电流的频率低于阻断电流的频率。通常所述刺激电流配置用以诱发多个动作电位(至少在没有所述阻断电流的情况下)，所述动做电位由所述对象经历为一感觉，例如感觉异常(paresthesia)或疼痛。对于一些应用，所述刺激电流配置用以诱发多个动作电位，所述动做电位不被所述对象经历(例如，为一感觉)。
各系统的所述刺激单元配置用以诱发传入的(afferent)多个动作电位，其被所述传感器单元检测。所述传感器单元(无线地或有线地)提供一传感器信号，所述传感器信号传达关于所述被检测的多个动作电位的信息(例如，其幅度和/或频率)。所述系统的电路配置用以接收所述传感器信号，并且对应性地改变所述阻断电流的参数，诸如幅度、频率或占空比(duty cycle)。因此，所述电路建立起所述阻断单元和/或所述阻断电流阻断所述被诱发的多个动作电位的有效性，并将所述阻断电流校准至有效但不过过高的水平，从而优化功率消耗，以及所述对象接收的电流量。
图1至图4显示相对于一对象的神经10和皮肤12的所述相应系统。标记“传入(afferent)”和“传出(efferent)”指示神经解剖结构的方向。神经10通常是一周围神经。对于一些应用，神经10是一脊神经。对于一些应用，神经10是脊髓的神经组织，并且所述植入物被植入(例如注射至)所述硬膜外腔(epidural space)中。
图1显示系统40，包括：(1)一可植入的刺激单元22，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；(2)一可植入的阻断单元24，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；(3)一可植入的传感器单元26，配置用以检测所述被诱发的多个动作电位，以及(4)一电路50，特别是配置成驱动所述刺激单元、所述阻断单元以及所述传感器单元。
系统40包括(1)一刺激植入物42，所述刺激植入物42包括刺激单元22以及一体内天线28(标示为28a)、(2)一阻断植入物44，所述阻断植入物44包括阻断单元24以及一体内天线28(标示为28b)、(3)一传感器植入物46，所述传感器植入物46包括传感器单元26以及一体内天线28(标示为28c)。一般而言，所述多个植入物的各者包括一壳体，以容置所述相应单元。所述多个植入物通常被植入在神经10的附近(例如在10毫米内，如在7毫米内)。植入所述植入物，使得(如图所示)植入物46在植入物44的传入(afferent)方向，植入物44在植入物42的传入(afferent)方向(因此单元26在单元24的传入(afferent)方向，单元24在单元22的传入(afferent)方向)。一般而言，植入物42、44和46通过注射而被植入，并且可以独立地植入或使用一单一注射装置。
对于一些应用，将植入物46植入在距植入物44的1至10毫米处(例如，2至5毫米)，植入物44植入在距植入物42 1至10毫米处(例如2至5cm)。
系统40进一步包括一体外控制器48，所述体外控制器48包括电路50以及体外天线32和提供电源至所述电路的电池34。(应当理解的是，天线32可以包括一或多个天线。)电路50配置成通过天线32和多个天线28无线地驱动(例如无线地提供电源和操作)刺激单元22、阻断单元24和传感器单元26。多个单元22,24和26(例如多个植入物42、44和46)可由体外控制器48(例如，通过其电路50)独立地寻址(addressable)。例如，当一特定单元将被驱动时，可以使用具有一特定特性(例如频率)的一无线电源信号，并且仅有所述单元由所述电源信号供电(例如，仅有所述单元的植入物的天线配置用以接收所述电源信号)。类似地，可以将一代码(code)调整(modulate)至电源信号上。
本文下面将描述系统40(以及系统60、80和100的操作)的操作(例如参考图5至图10)。
图2显示系统60，包括刺激单元22、阻断单元24、传感器单元26和电路70，电路70配置用以驱动刺激单元、阻断单元和传感器单元。
系统60包括一植入物62，植入物62包括刺激单元22、阻断单元24和传感器单元26，以及体内天线28(标示为28d)。一般而言，植入物62包括一壳体64以容置单元22、单元24和单元26以及天线28d。壳体64通常是长形的。一般而言，植入物62植入在神经10的附近(例如在10毫米内，如在7毫米内)，例如，使得所述植入物的一纵向轴线与神经对齐。将植入物62植入，使得单元26在单元24的传入(afferent)方向，单元24在单元22的传入(afferent)方向。一般而言，植入物62通过注射而植入。
对于一些应用，植入物62的尺寸使得单元26(例如其(多个)电极)位在距单元24(例如其(多个)电极)的0.5至5毫米处(例如1至2毫米)。对于一些应用，植入物62的尺寸使得单元24(例如其(多个)电极)位在距单元22(例如其(多个)电极)的0.5至5毫米处(例如1至2毫米)。
系统60进一步包括一体外控制器68，所述体外控制器包括电路70，以及体外天线32和为电路供电的电池34。电路70配置成通过天线32和天线28d无线地驱动(例如无线地提供电源和操作)刺激单元22、阻断单元24和传感器单元26。多个单元22,24和26可由体外控制器68(例如，通过其电路70)独立地寻址(addressable)。例如，以将一代码(code)调整(modulate)至电源信号上，并且植入物62可包括植入物电路66(例如包括一开关)，其因应于所述代码，将所述接收的电源引导至所述适当的单元。可替代地，植入物62可以包括用于单元22,24和26中的各者的一单独天线(例如如对系统20所示并做必要修改)，并且所述无线电源信号配置用以具有一特定特性(例如频率)使得只有一特定天线配置用以接收。
因此，对于本发明的一些应用，系统60类似于系统20，除了单元22,24和26被容置在一单一植入物内，而不是在分离的植入物内。
系统60的操作(以及系统40、80和100的操作)将在本文下面描述(例如参考图5至图10)。
图3显示系统80，包括刺激单元22、阻断单元24、传感器单元26和电路90，电路90特别配置用以驱动刺激单元、阻断单元和传感器单元。
系统80包括一植入物82，所述植入物82包括刺激单元22、阻断单元24和传感器单元26，以及一体内天线28(标示为28e)。在这方面，系统80与系统60相同。然而在系统60(和系统40)中，驱动单元24、26和28的电路位在一体外控制器内，在系统80中，植入物82包括电路90。也就是说，电路90是植入物电路。一般而言，植入物82包括一壳体84，已容置单元22、24和26、天线28e和电路90。壳体84通常是长形的。一般而言，植入物82植入在神经10附近(例如在10毫米内，例如在7毫米内)，例如使得所述植入物的纵向轴线与所述神经对齐。植入植入物82，使得单元26在单元24的传入(afferent)方向，单元24在单元22的传入(afferent)方向。通常，植入物82通过注射而植入。
系统80还包括一体外控制器88，体外控制器88包括体外天线32和电池34。然而在系统40和60中，所述体外控制器(例如其电路)驱动单元22、24和26，在系统80中，控制器88仅通过天线32和28e提供无线电源至植入物82。也就是说，控制器88无线地提供电路90电源，驱动(例如一般而言有线地操作)单元22、24和26。单元22、24和26可独立被电路90寻址(addressable)。
因此，对于本发明的一些应用，系统80类似于系统60，除了驱动多个单元24,26和28的电路是位在植入物内，而不是在体外控制器内。
本文下面将描述系统80(以及系统40,60和100的操作)的操作(例如参考图5至图10)。
图4显示系统100，包括刺激单元22、阻断单元24、传感器单元26和电路110，电路110特别配置用以驱动刺激单元、阻断单元和传感器单元。
系统100包括一植入物102，植入物102包括刺激单元22、阻断单元24和传感器单元26，类似于植入物82，电路110是植入电路。然而在系统80中，由体外控制器提供电力，所述体外控制器将电源无线地传输到所述植入物的天线。在系统100中，植入物102包括一电池106。一般而言，植入物102包括一壳体104，所述壳体104容置多个单元22、24和26、电路110和电池106。壳体104通常是长形的。一般而言，将植入物102植入在神经10附近(例如在10毫米内，如在7毫米内)，例如使得植入物的纵向轴与神经对齐。植入物102被植入，使得单元26在单元24的传入(afferent)方向，单元24在单元22的传入(afferent)方向。一般而言，植入物102通过注射而植入。
因此，对于本发明的一些应用，系统100类似于系统80，除了电池由植入物内的电池提供，而不是从一体外控制器无线地接收。应注意的是，尽管有这种区别，植入物102(例如其电池106)可以是无线再充电的。
本文下面将描述系统100(以及系统40、60和80的操作)的操作(例如参考图5至图10)。
再次参考图1至图4。植入物42、44、46、62和82通常不包括非瞬时电源存储组件(non至transient power storage element)(例如电池)，尽管其可以包括多个电容器。类似地，植入物42、44、46和62一般而言仅包括简单的电路，在体外控制器不存在时，不能执行下文所述的操作。因此，上文所述的体外控制器通常在其各自的植入物的实时操作(real至time operation)期间存在。也就是说，所述植入物的供电和/或操作通常由体外控制器实时地执行。一般而言，所述多个体外控制器可连附至所述受试者的身体，例如使用一带件21，并且足够轻小，以便在一天的大部分时间中配戴。
参考图5至图10，其显示根据本发明的一些应用中的系统40、60、80和100的操作的示意图。
图5是根据本发明的一些应用，由系统40,60,80和100的所述电路执行的一校准程序120的至少一些步骤的流程图。如上所述，各系统的电路被配置用以(1)驱动所述刺激单元、所述阻断单元和所述传感器单元(步骤122)，(2)接收所述传感器信号(步骤124)，以及(3)因应于所述传感器信号，改变所述阻抗电流的参数(即校准)(步骤126)。所述刺激单元、阻断单元与传感器单元的驱动显示在在一单一步骤122之内，因为尽管(如参考图6至图9所描述)在程序操作期间，当所述刺激单元和所述传感器单元为“关闭”时，所述阻断单元通常也为“开启”，在校准程序期间，所有三个单元在相同时间被驱动(例如在10毫秒之内，例如彼此在5毫秒内)。
图6至图10是根据本发明的各种应用中，所述阻断单元、所述刺激单元和所述传感器单元的驱动之间的时间关系的示意图。也就是说，图6至图10显示根据本发明的各种应用中，所述校准程序和治疗模式之间的时间关系。
在图6至图9，执行所述阻断单元、所述刺激单元和所述传感器单元的同时驱动作为一校准程序运行的一部分。如上所描述，本文所描述的系统的主要功能通常是通过所述阻断单元阻断不想要的多个动作电位。因此，在程序操作期间，当所述刺激单元和所述传感器单元为“关闭”时，所述阻断单元通常也为“开启”(例如即使在刺激单元和传感器单元维持在“开启”
之后的几分钟、几小时或几天)。图6显示出了这一点，其显示在一段时间内持续的阻断(例如一小时、一天或一周)并具有周期性校准(例如每隔几分钟(例如10分钟)、每小时或每天)。然而如图7所示，阻断不需要总是持续的，并且可以提供周期性停止的阻断。图7还示显示对于一些这样的应用，在各连续阻断期间的过程中，执行多个校准。图8显示对于一些应用，在各阻断周期的过程中(例如，在其开始，中间或结束时)执行一单一校准。图9显示对于一些应用，在阻断周期的过程中不执行校准，可以在执行校准的阻断周期之间提供一或多个无校准的阻断周期。
可替代地或另外地，在治疗开始时(例如在植入后不久)进行初始校准，例如由医生或其它医疗从业者启动。
如上所述，在所述校准程序期间，同时驱动所述阻断单元、所述刺激单元和所述传感器单元，以检测未被阻断单元成功阻断的多个被诱发的动作电位。对于一些应用，执行一自检(self至checking)步骤(例如作为校准程序的一部分，或独立于校准程序)，以确保缺少检测到的被诱发的多个动作电位(或低的多个动作电位)实际上是由于成功的阻断，而不是由于多个动作电位的无效感应或检测(即刺激单元或传感器单元的无效执行)。在这种自检步骤中，刺激单元和传感器单元都被驱动，但是阻断单元未被驱动。
图10显示这种自检步骤的一示例。刺激单元和传感器单元正好在阻断开(再次)开始之前被开启，使得在短暂的周期140期间(例如100毫秒至10秒，例如100毫秒至5秒，例如100毫秒至2秒)任何被诱发的动作电位可以持续，不受阻碍地到达传感器单元。因应于在周期140期间，检测多个动作电位，所述传感器单元提供一传感器信号，传达关于被检测到的多个动作电位的信息(例如，其幅度和/或频率)，并且所述电路接收并响应所述传感器信号。对于一些应用中，周期140的简短是重要的，因为这种诱发的多个动作电位可以使受试者经历不适、感觉异常或疼痛(例如类似于经历不想要的多个内源动作电位的方式)。
对于一些应用，因应于来自周期140的所述传感器信号，所述系统的电路改变所述刺激电流的参数(例如重新配置)和/或重新配置所述传感器单元(例如其一灵敏度)。
对于一些应用，所述系统的电路将在周期140期间检测到的多个动作电位与在周期142期间检测到的多个动作电位进行比较(在所述周期142中，所述阻断单元也被驱动)，并且流因应于所述比较，重新配置所述刺激电流、所述传感器单元和/或阻断电流。
对于一些应用，如果周期140中所检测到的多个动作电位不足(例如，强度不足)，这是由所述体外控制单元所指示，并且所述植入物可以重新定位或移除。
对于一些应用，因应于来自周期140的传感器信号，所述系统的电路改变所述阻抗电流的一参数(例如重新配置)。
自检可以执行(例如可提供周期140)一次(如在植入时，例如由医生直行)，偶尔执行(例如在系统的一例行的“服务”期间执行)，定期地执行(例如每天执行一次)，或经常地执行(例如在各校准程序之前执行，例如自动地执行)。自检可以在校准程序之前或之后立即执行(例如可以在周期142之前或之后立即提供周期140)，如图10所示，或者可以单独执行。
现在参考图11至图12，其为根据本发明的一些应用中，用于一对象的一神经的系统160以及所述系统的操作的示意图。除非另有说明，否则系统160通常类似于系统60。系统160包括刺激单元22、阻断单元24和电路170，所述电路170配置用于驱动所述刺激单元和所述阻断单元。
系统160包括植入物162，所述植入物162包括刺激单元22和阻断单元24，以及一体内天线28(标示为28f)。通常，植入物162包括一壳体164以容置单元22和24以及天线28f。壳体164通常是长形的。通常，植入物162植入在神经10附近(例如在10毫米内，例如在7毫米内)，例如使得植入物的纵向轴与神经对齐。将植入物162植入，使得单元24在单元22的传入(afferent)方向。通常，植入物162通过注射而植入。
系统160进一步包括一体外控制器168，所述体外控制器168包括电路170以及体外天线32和为电路提供电源的电池34。电路170配置成经由天线32和天线28f无线地驱动(例如无线地供电和操作)刺激单元22和阻断单元24。多个单元22和24可由体外控制器168(例如，通过其电路170)独立地寻址(addressable)。例如，以将一代码(code)调整(modulate)至电源信号上，并且植入物162可包括植入物电路166(例如包括一开关)，其因应于所述代码，将所述接收的电源引导至所述适当的单元。可替代地，植入物162可以包括用于单元22和24中的各者的一单独天线，并且所述无线电源信号配置用以具有一特定特性(例如频率)使得只有一特定天线配置用以接收。
因此对于本发明的一些应用，系统160类似于系统60，除了其缺少传感器单元。控制器168包括一接口172，所述接口172通常包括一显示器和/或一输入装置，诸如按钮或拨号盘。系统160的所述阻断电流的校准通常是手动地执行。刺激单元22因应于接口172的使用者操作而驱动控制器168(例如所述校准程序的启动)。刺激单元22诱发的传入的(afferent)多个动作电位由所述对象经历，例如为一感觉、不适(discomfort)、感觉异常(paresthesia)或疼痛(pain)。当刺激单元继续启动这些多个动作电位时，阻断单元24被控制器168驱动。(阻断单元24的驱动可以与刺激单元22的驱动同时开始，可以在一延迟之后自动开始，或者可以从使用者操作的接口172接收到一单独的指令时开始)。通过操作接口172，使用者(例如所述对象或医生)手动地使电路170无线地校准所述阻断电流，直到所经历的诱发的多个动作电位较不强烈时(例如直到他们不再经历此感觉)。
应当注意，本发明的范围包括一系统类似于系统160，但是以植入电路取代电路170(例如类似于系统80的植入电路90，通过必要的修改)。类似地，本发明的范围包括没有一体外控制器的类似系统，而是包括一电池的植入物(例如类似系统100，通过必要的修改)。
对于一些应用，如图所示，激励单元22设置在长形壳体164的一第一半部(例如，包括所述壳体的一第一端部的一半部)内，并且阻断单元24设置在所述壳体的一第二半部内(例如，包括所述壳体的一第二相对端的一半部)。因此，对于一些应用，提供一植入物，具有一纵向轴，沿着所述纵向轴可注射进入到所述对像中，并且包括：
(1)一长形壳体，具有包括一第一端的一第一半部和包括一第二端的一第二半部；
(2)至少一感觉异常诱发(paresthesia至inducing)电极(例如刺激单元22的)，设置在所述壳体的所述第一半部内的一第一位置上；
(3)至少一阻断电极(例如阻断单元24的)，设置在所述壳体的所述第二半部内的一第二位置上；以及
(4)一电路(其可为电路170，或可为植入电路)，具有：
一第一模式(即所述校准程序)，其中所述电路同时驱动(a)所述至少一感觉异常诱发电极，以施加一感觉异常诱发电流，所述感觉异常诱发电流具有2至400Hz的一频率，以及(b)所述至少一阻断电极，以施加一阻断电流，所述阻断电流具有1至20kHz的一频率，以及
一第二模式(即所述治疗模式)，其中所述电路(1)驱动所述至少一阻断电极以施加所述阻断电流，但是(2)不驱动所述至少一感觉异常诱发电极施加所述感觉异常感生电流。
图12是根据本发明的一些应用中，在系统160上执行校准程序180的至少一些步骤的流程图。如上所述，系统160的电路170被配置为(1)驱动刺激单元22和阻断单元24(步骤182)，(2)通过使用者接口172的使用者操作接收输入(步骤184)和(3)因应于所述输入，改变所述阻抗电流的一参数(即校准)(步骤186)。所述刺激单元和阻断单元的驱动显示在在一单一步骤182之内，因为尽管(如本文上面所描述)在程序操作期间，当所述刺激单元为“关闭”时，所述阻断单元通常也为“开启”，在校准程序期间，两个单元在相同时间被驱动(例如在10毫秒之内，例如彼此在5毫秒内)。
系统160的校准程序相对于其治疗模式的时机可以根据那些被描述的多个系统40、60、80和100的一者或多者(例如参考图6至图10)，必要时加以修改。类似地，可以在系统160上执行自检，其中刺激单元22被驱动，而阻断单元24未被驱动。
再次参考图1、图2、图5至图10、图11及图12。应当注意的是，对于多个系统40、60和160中的各者，所述系统包括：
(1)可植入的刺激单元22，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；
(2)可植入的阻断单元24，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；以及
(3)体外控制器(即控制器48、68或168)，包括至少一天线，和电路(即电路50、70或170)。
如上所描述，各系统的主要功能是阻断不想要的多个内源(endogenous)动作电位。因此，在所述系统(即所述体外控制器)的一第一模式(即一治疗模式)中，驱动所述阻断电流而不驱动所述刺激电流。通常，至少90％的时间中所述阻断电流被驱动，而刺激电流不被驱动。因此，在所述系统(即所述体外控制器)的一第二模式(即一校准模式)中，驱动所述阻断电流以及所述刺激电流，即校准程序。通常，只有在自检期间，驱动所述刺激电流而不驱动所述阻断电流。通常，即使在使用自检程序的应用中，超过30％的时间，驱动所述刺激电流也驱动所述阻断电流。
所述电路(即电路50、70或170)，配置成：
(1)无线地驱动所述刺激单元以施加所述刺激电流，
(2)在所述体外控制器的一第一模式(即所述治疗模式)中，无线地驱动所述阻断单元以施加所述阻断电流，同时不驱动所述刺激单元施加所述刺激电流，
(3)在所述体外控制器的一第二模式(即所述校正模式)中，无线地驱动所述阻断单元以施加所述阻断电流，同时驱动所述刺激单元以施加所述刺激电流，以及
(4)当所述体外控制器处于所述第二模式时，根据执行的感测，无线地改变所述阻断电流的一参数。如上所述，对于系统40和60，所述感测是由传感器单元26执行，并且所述电路自动接收并响应其(即所述传感器信号)。对于系统160，所述感测是由所述对象执行，所述对象因应于地手动操作所述电路所响应的接口172。
对于一些应用，所述第一模式和第二模式之间的切换由电路(例如根据一校准程序)自动地执行。也就是说，对于一些应用中，所述电路自动周期性地将体外控制器切换到用于所述校准程序的所述第二模式，并且随后将其切换回所述第一模式。对于一些应用，所述电路被配置成因应于于所述使用者接口的使用者操作，用以在所述第一和第二模式之间切换所述体外控制器(即由所述对象或医生手动启动和/或执行校准)。
在自检期间(例如在周期140期间)，所述体外控制器可以被认为是在一第三模式，其中驱动所述刺激单元而非所述阻断单元。
再次参考图1至图12。各系统的主要功能是阻断不想要的多个内源(endogenous)动作电位。因此，在所述系统(即所述体外控制器)的一第一模式(即一治疗模式)中，驱动所述阻断电流而不驱动所述刺激电流。通常，至少90％的时间中所述阻断电流被驱动，而刺激电流不被驱动。在所述系统的一第二模式(即一校准模式)中，驱动所述阻断电流以及所述刺激电流，即校准程序。通常，只有在自检期间，驱动所述刺激电流而不驱动所述阻断电流。通常，即使在使用自检程序的应用中，超过30％的时间，驱动所述刺激电流也驱动所述阻断电流。阻断单元24的驱动(无论是无线地通过体外电路还是有线地通过植入电路)通过提供一阻断指令信号(其通常提供电源至所述阻断单元)的电路来实现。所述信号具有一能量消耗，并且各系统的所述校准程序配置用以尽可能地减少所述能量消耗。至少因为驱动所述刺激电流比所述阻断电流小得多(例如，因为较短的周期和/或较低的频率)，所以校准程序所需的额外能量消耗被所述阻断命令信号的所减少的能量消耗所补偿。
再次参考图1至图12，本文所述的植入物通常是可注射的，并且为了便于操作，通常将其尺寸设计为适合纵向穿过一8至16号针管(例如一11至14号针管)。
本领域技术人员将了解本发明不局限于在上文中已经被特别显示和描述的事物。而本发明的范围包括上文描述的各种非现有技术的特征的组合和子组合以及修改形式，其可被本领域技术人员了解，当阅读前面的非描述。

Claims (15)

1.一种使用于一对象的一神经的装置，其特征在于：所述装置包括：
一可植入的刺激单元，配置成通过对所述神经施加一刺激电流以诱发所述神经中的多个动作电位；
一可植入的阻断单元，配置成通过对所述神经施加一阻断电流以阻断所述被诱发的多个动作电位沿着所述神经传递；以及
一体外控制器，包括(1)至少一天线，和(2)一电路，配置成：
无线地驱动所述刺激单元以施加所述刺激电流，
在所述体外控制器的一第一模式中，无线地驱动所述阻断单元以施加所述阻断电流，同时不驱动所述刺激单元施加所述刺激电流，
在所述体外控制器的一第二模式中，无线地驱动所述阻断单元以施加所述阻断电流，同时驱动所述刺激单元以施加所述刺激电流，以及
当所述体外控制器处于所述第二模式时，根据执行的感测，无线地改变所述阻断电流的一参数。
2.如权利要求1所述的装置，其特征在于：所述电路被配置成在所述第一模式和所述第二模式之间自动地周期性地切换所述体外控制器。
3.如权利要求1所述的装置，其特征在于：所述装置进一步包括一植入物，所述植入物包括一壳体以容置所述刺激单元和所述阻断单元。
4.如权利要求1所述的装置，其特征在于：所述电路配置成在所述体外控制器的一第三模式中，无线地驱动所述刺激单元以施加所述刺激电流，同时不驱动所述阻断单元施加所述阻断电流。
5.如权利要求1至4任一项所述的装置，其特征在于：所述刺激电流具有2至400Hz的一频率，并且所述电路配置成无线地驱动所述刺激单元以施加具有2至400Hz的所述频率的所述刺激电流。
6.如权利要求5所述的装置，其特征在于：所述刺激电流具5至100Hz的一频率，并且所述电路配置成无线地驱动所述刺激单元以施加具有5至100Hz的所述频率的所述刺激电流。
7.如权利要求1至4任一项所述的装置，其特征在于：所述阻断电流具有1至20Hz的一频率，并且所述电路配置成无线地驱动所述阻断单元以施加具有1至20Hz的所述频率的所述阻断电流。
8.如权利要求7所述的装置，其特征在于：所述阻断电流具有3至10Hz的一频率，并且所述电路配置成无线地驱动所述阻断单元以施加具有3至10Hz的所述频率的所述阻断电流。
9.如权利要求1至4任一项所述的装置，其特征在于：所述装置还包括一可植入的传感器单元，配置用以检测所述神经中的所述被诱发的多个动作电位，并对应性地提供一传感器信号，所述传感器信号传达关于所述被检测到的被诱发的多个动作电位的信息，以及其中所述体外控制器的所述电路配置用以无线地接收所述传感器信号，并且因应于所述接收的传感器信号而改变所述阻断电流的所述参数。
10.如权利要求9所述的装置，其特征在于：所述装置还包括一植入物，所述植入物包括一壳体以容置所述刺激单元、所述阻断单元和所述传感器单元。
11.如权利要求9所述的装置，其特征在于：所述电路被配置用以自动地周期性地运行一校准程序，所述校准程序包括：
(a)将所述体外控制器切换至所述第二模式，
(b)接收所述传感器信号，所述传感器信号传达关于当所述体外控制器处于所述第二模式中时所检测到的被诱发的多个动作电位的信息，
(c)因应于在所述校准程序的步骤(b)中所接收到的所述传感器信号，改变所述阻断电流的所述参数，以及
(d)将所述体外控制器切换至所述第一模式。
12.如权利要求11所述的装置，其特征在于：所述电路被配置成在所述体外控制器的一第三模式中，无线地驱动所述刺激单元以施加所述刺激电流，同时不驱动所述阻断单元施加所述阻断电流，并且其中在步骤(a)之前，所述校准程序还包括：
(1)将所述体外控制器切换为所述第三模式，以及
(2)接收所述传感器信号，所述传感器信号传达当所述体外控制器处于所述第三模式中时所检测到的被诱发的多个动作电位的信息。
13.如权利要求12所述的装置，其特征在于：所述校准程序的步骤(c)包括：因应于在所述校准程序的步骤(b)中接收的所述传感器信号，以及因应于在所述校准程序的步骤(2)中接收的所述传感器信号，改变所述阻塞电流的所述参数。
14.如权利要求1至4任一项所述的装置，其特征在于：所述体外控制器进一步包括一使用者接口，并且其中所述电路配置成因应于所述使用者接口的一使用者操作，无线地改变所述阻断电流的所述参数。
15.如权利要求14所述的装置，其特征在于：所述电路配置成因应于所述使用者接口的一使用者操作，在所述第一模式和所述第二模式之间切换所述体外控制器。
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