CN106714896B - 神经刺激定量给予 - Google Patents
神经刺激定量给予 Download PDFInfo
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Abstract
施加治疗性神经刺激涉及监测用户的感觉输入和运动中的至少一个。响应于感觉输入或用户运动的检测,在对应于检测到的感觉输入或用户运动引起掩蔽的持续时间的时间段内递送增加的刺激剂量,该增加的刺激剂量被配置为引起增加的神经募集。
Description
技术领域
本发明涉及治疗性神经刺激的施加,并且具体地涉及通过使用植入在神经通路近端的一个或多个电极,以可变方式施加期望剂量的刺激,以使不利影响最小化。
发明背景
存在其中需要施加神经刺激以便引起复合动作电位(CAP)的一系列情况。例如,神经调节用于治疗多种病症,包括慢性神经性疼痛、帕金森氏病以及偏头痛。神经调节系统向组织施加一个电脉冲以产生治疗效果。
当用于缓解源于躯干和四肢的神经性疼痛时,施加电脉冲到脊髓的背柱(DC)。这样的一个系统典型地包括一个植入式电脉冲发生器,以及一个电源,例如可以通过经皮感应传递而可再充电的电池。将一个电极阵列连接至该电脉冲发生器,并且将其放置于背柱上的背侧硬膜外腔中。由电极向背柱施加的电脉冲导致神经元的去极化,以及传播动作电位的产生。被以此方式刺激的纤维抑制疼痛从脊髓中的那个区段向大脑的传递。为了维持疼痛缓解效果,基本上连续地施加刺激,例如以30Hz-100Hz范围的频率施加。
尽管脊髓刺激(SCS)的临床效果是明确的,但是涉及的精确机制却知之甚少。DC是电刺激的靶标,因为它包含感兴趣的传入Aβ纤维。Aβ纤维介导来自皮肤的触摸、振动以及压力的感觉。
为了有效且舒适的操作,需要将刺激幅度或递送的电荷维持在一个募集阈值之上。刺激低于该募集阈值将无法募集任何动作电位。还需要施加低于舒适阈值的刺激,高于该舒适阈值时,会由于增加Αβ纤维的募集而产生不舒服或疼痛的感觉;当Αβ纤维的募集太大时产生不舒服的感觉,并且在高刺激水平下甚至可能募集与急性疼痛、寒冷和压觉相关的感觉神经纤维。在几乎所有的神经调节应用中,需要单类的纤维反应,但是所采用的刺激波形可以募集引起不想要的副作用的其他类纤维,例如,如果募集传入或传出的运动纤维,则会引起肌肉收缩。由于电极迁移和/或植入接受者的姿势变化,维持适当的神经募集的任务变得更加困难,电极迁移以及植入接受者的姿势变化中的任一者都可以取决于刺激是在电极位置或用户姿势变化之前或之后施加而显著地改变从给定刺激中产生的神经募集。在硬膜外腔中存在用于电极阵列移动的空间,并且这种阵列移动改变电极到纤维的距离,并且因此改变了给定刺激的募集效率。此外,脊髓本身可以相对于硬脑膜在脑脊液(CSF)内移动。在体位改变期间,CSF的量和脊髓与电极之间的距离可以显著变化。这种效果是如此之大以使得单独的姿势变化可以导致一个从前舒适且有效的刺激方案变得无效或疼痛。
已经被包括在本说明书中的文献、作用、材料、装置、物品或类似物的任何讨论唯一用于提供本发明的背景的目的。这并不被看作是承认任何或所有这些事项形成现有技术基础的一部分或任何或所有这些事项是与本发明相关的领域中的公共常识,虽然它在本申请的每个权利要求的优先权日之前存在。
贯穿本说明书,“包括(comprise)”一词或变化形式(例如“包括了(comprises)”或“包括着(comprising)”)应被理解为意指包括所陈述的要素、整体或步骤,或者多个要素、整体或步骤的群组,但不排除任何其他要素、整体或步骤,或者多个要素、整体或步骤的群组。
在本说明书中,元素可以是“选项列表中的至少一个”的陈述应被理解为该元素可以是所列出的选项中的任何一个,或者可以是所列出的选项中的两个或更多个的任意组合。
发明概述
根据第一方面,本发明提供一种施加治疗性神经刺激的方法,该方法包括:
监测用户的感觉输入和运动中的至少一个;并且
响应于感觉输入和用户运动中的至少一个的检测,在对应于检测到的感觉输入或用户运动引起掩蔽的持续时间的时间段内递送增加的刺激剂量,该增加的刺激剂量被配置为引起增加的神经募集。
根据第二方面,本发明提供一种用于施加治疗性神经刺激的装置,该装置包括:
至少一个电极,该电极被配置为沿着用户的神经通路定位;以及
控制单元,该控制单元被配置为监测所述用户的感觉输入和运动中的至少一个,并且被配置为:响应于感觉输入和用户运动中的至少一个的检测,在对应于所检测到的感觉输入或用户运动引起掩蔽的持续时间的时间段内经由所述至少一个电极递送增加的刺激剂量,该增加的刺激剂量被配置为引起增加的神经募集。
本发明的第一和第二方面认可,在运动或感觉输入期间,与当在个体未运动也未接收感觉输入时施加相同的刺激相比,感知的心理物理学可导致个体感知到来自给定刺激的感觉减少。然而,递送大剂量的刺激的益处在刺激结束后会保持一段时间。因此,本发明的第一和第二方面认可,用户正在运动或接收感觉输入的时间段提供了递送增加剂量的刺激的机会。
在本发明的第一和第二方面的一些实施例中,增加的刺激剂量可以通过增加刺激幅度、刺激脉冲宽度和/或刺激频率中的一个或多个来实现。增加的刺激剂量可以例如包括高频刺激的突发,例如10kHz,40μs脉冲宽度和2mA幅度的刺激。当既没有检测到感觉输入也没有检测到运动时,能以减小的剂量,例如以20或30Hz的剂量递送刺激,或甚至根本不递送刺激。
在一些实施例中,递送给用户的累积刺激剂量可以被监测,并且可以被用作基础来限定在感觉输入或运动期间和/或在没有感觉输入和没有运动期间所需刺激方案,以设法在一个剂量周期如一小时或一天的过程中递送所需的总刺激剂量。
在一些实施例中,通过测量神经通路上的神经活动来检测用户的感觉输入或运动。测量的神经活动可以包括由施加到神经通路的电刺激产生的诱发神经反应,并且例如当在从给定刺激诱发的神经反应中检测到变化时,可以检测感觉输入或运动。测量的神经活动可另外地或替代地包括非诱发的神经活动,非诱发的神经活动是由于除了由装置施加电刺激之外的原因而存在于神经通路上的神经活动。这样的实施例认可,在感觉输入或用户运动的时期期间,非诱发的神经活动显著上升,使得可以采用观察到的非诱发的神经活动的增加或改变来指示感觉输入或用户运动。
在其他实施例中,用户的运动可以由加速度计或其他运动检测器检测。
递送增加的刺激剂量的时间段可以被预先定义为典型的人类运动的持续时间的近似值,并且例如可以被预先定义为持续时间为一秒的量级。另外地或可替代地,递送增加的刺激剂量的时间段可以通过执行检测用户的感觉输入或运动的停止并继而停止增加的刺激剂量的递送的进一步的步骤来适应性地确定。
另外地或可替代地,递送增加的刺激剂量的时间段可以被预先定义或适应性地确定为取对应于非诱发的神经活动的典型持续时间的值。例如,在一些实施例中,递送增加的刺激剂量的时间段可以在10-100ms、或更优选20-40ms、更优选约30ms的范围内。在这样的实施例中,刺激剂量的增加可以涉及施加增加的刺激频率,例如通过将刺激频率从60Hz增加到1kHz,以便在30ms窗口的非诱发的神经活动期间递送约30个刺激,而不是仅递送如在60Hz下发生的约2个刺激。
另外地或可替代地,增加的刺激剂量递送的时间段和/或增加的刺激剂量的刺激强度可以适应性地通过执行测量运动或感觉输入的强度并且从运动强度确定时间段和/或刺激强度的进一步步骤来确定,例如该时间段和/或刺激强度可以与运动力量成比例。运动或感觉强度可以例如包括所检测到的运动或感觉输入的量级或功率,或所检测到的运动或感觉输入的其他强度测量。在此类实施例中,随着时间的推移,随着感觉阈值随运动或感觉输入变化,可以控制刺激强度保持低于用于感觉的一定量或分数的阈值,从而避免或最小化引起异常感觉的刺激,同时维持治疗剂量的刺激。
增加的刺激剂量可以在整个时间段内或在该时间段内的选定时刻递送,例如仅在感觉输入或运动或该时间段的开始和/或停止时递送。
根据第三方面,本发明提供了一种用于实现神经阻滞的方法,该方法包括:
向神经组织递送电刺激序列,每个刺激以一定水平配置,由此至少在刺激电极与神经组织的给定相对位置处,序列的第一刺激产生动作电位,并且由此每个随后的刺激改变神经组织的膜电位而不引起神经组织的去极化,也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送,使得刺激序列将膜电位维持在动作电位的传导被阻止或防止的可变范围内。
根据第四方面,本发明提供了一种用于实现神经阻滞的装置,该装置包括:
至少一个电极,该电极被配置为沿着用户的神经通路定位;以及
被配置为向神经组织递送电刺激序列的控制单元,每个刺激以一定水平配置,由此至少在电极与神经组织的给定相对位置处,序列的第一刺激产生动作电位,并且由此每个随后的刺激改变神经组织的膜电位而不引起神经组织的去极化,也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送,使得刺激序列将膜电位维持在动作电位的传导被阻止或防止的可变范围内。
因此,本发明的第三和第四方面的实施例施加了一系列刺激,这些刺激首先产生动作电位,然后产生阻滞,该阻滞在刺激序列将膜电位维持在动作电位的传导被阻止或防止的可变范围内期间出现。在一些实施例中,可以通过施加超阈值刺激的序列来实现阻滞,其中第一刺激将引起动作电位。附加或替代实施例可以通过施加在第一姿势中是亚阈值但在用户运动到第二姿势时变为超阈值的刺激序列来实现阻滞。在这样的实施例中,在刺激阈值下降到刺激幅度以下之后递送的第一刺激将引起动作电位。阻滞是有益的,因为在阻滞期间递送的刺激在刺激位点唤起很少或并不唤起动作电位,并且因此将导致感觉异常的显著降低的影响或甚至完全缺失。
在本发明的第三和第四方面的一些实施例中,刺激序列能以大于500Hz,更优选地大于1kHz的频率或平均频率被递送,并且例如可以在5-15kHz的范围内递送。在一些实施例中,可以通过确定受试者的平均不应期,例如通过使用国际专利申请公开号WO 2012155189的技术来定义频率,其内容通过引用并入本文。然后可以设定所递送的刺激的频率,使得刺激间时间小于确定的不应期,或者是其适当的分数或倍数。
在本发明的第三和第四方面的一些实施例中,标称亚阈值水平可以例如由临床医生在为用户装配植入刺激器时预先设定。在一些实施例中,标称亚阈值水平设定为在给定姿势中是刺激阈值的大部分的水平,例如是该姿势中的刺激阈值的50%、75%、或90%大。可以适应性地确定标称亚阈值水平,例如通过不时地重复确定神经组织的募集阈值,像通过测量由刺激诱发的神经反应,以及通过参考最近确定的阈值水平重新设定标称亚阈值水平。在一些实施例中,以基本上大于典型人类运动的持续时间的时间间隔确定神经组织的募集阈值,以允许在运动期间建立神经阻滞。
根据本发明的第一方面,本发明的一些实施例可以仅在检测到的感觉输入或运动的时候根据本发明的第三方面实现阻滞。在此类实施例中,感觉输入或运动的检测可以通过在标称亚阈值水平下连续递送阻滞刺激来实现,由此阻滞刺激仅在感觉输入或运动期间起作用,这导致瞬时募集阈值下降至标称亚阈值水平以下。可替代地,在此类实施例中,阻滞可以响应于检测到感觉输入或运动而开始从而由该序列的第一刺激所产生的动作电位被感觉输入或运动掩蔽。
根据第五方面,本发明提供了一种计算机程序产品,其包括使计算机执行用于施加治疗性神经刺激的过程的计算机程序代码装置,该计算机程序产品包括:
用于监测用户的感觉输入和运动中的至少一个的计算机程序代码装置;以及
计算机程序代码装置,用于响应于感觉输入和用户运动中的至少一个的检测,在对应于检测到的感觉输入或用户运动引起掩蔽的持续时间的时间段内递送增加的刺激剂量,该增加的刺激剂量被配置为引起增加的神经募集。
根据第六方面,本发明提供了一种计算机程序产品,其包括使计算机执行用于实现神经阻滞的过程的计算机程序代码装置,该计算机程序产品包括:
用于向神经组织递送电刺激序列的计算机程序代码装置,每个刺激以一定水平配置,由此至少在刺激电极与神经组织的给定相对位置处,序列的第一刺激产生动作电位,并且其中每个随后的刺激改变神经组织的膜电位而不引起神经组织的去极化,也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送,使得刺激序列将膜电位维持在动作电位的传导被阻止或防止的改变的范围内。
在本发明的第五和第六方面的一些实施例中,计算机程序产品包括非暂时性计算机可读介质,该介质包括由一个或多个处理器执行的指令。
附图简要说明
现在将参照以下附图对本发明的实例进行描述,其中:
图1图解地示出了植入的脊髓刺激器;
图2是植入的神经刺激器的框图;
图3是植入的刺激器与神经的相互作用的图解示意;
图4示出了强度持续时间曲线,随后是在轴突中动作电位产生的阈值;
图5示出了递送高频脉冲序列对强度持续时间曲线的影响;
图6显示了个体在多种不同姿势下的幅度生长曲线;
图7显示了对应于背柱激活的强度持续时间曲线;
图8示出了维持恒定ECAP响应所需的刺激电流的监测;
图9显示了患者静息时的ECAP记录的实例;
图10显示了患者在现场行走的ECAP记录;
图11显示从患者测量的非诱发的活动;
图12示出了根据本发明的一些实施例施加的刺激方案;
图13示出了在阻滞期间记录的神经电压;
图14示出了运动活动检测器的操作;
图15-17示出了在患者运动期间观察到的神经反应信号,以及由图14的检测器递送的所得刺激方案;并且
图18示出了根据本发明另一实施例的神经活动检测器的操作。
优选实施例的说明
图1图解地示出了植入的脊髓刺激器100。刺激器100包括植入在患者的下腹部区域或后上臀区域中的适当位置处的电子模块110,以及植入硬膜外腔内并通过适当的导线连接到模块110的电极组件150。植入的神经装置100的操作的许多方面可由外部控制装置192重新配置。而且,植入的神经装置100充当数据收集角色,其中收集的数据被传送到外部装置192。
图2是植入的神经刺激器100的框图。模块110包含电池112和遥测模块114。在本发明的实施例中,遥测模块114可以使用任何合适类型的经皮通信190,例如红外(IR)、电磁、电容和电感传输,以在外部设备192和电子模块110之间传递电力和/或数据。
模块控制器116具有存储患者设置120、控制程序122等的相关联的存储器118。控制器116控制脉冲发生器124根据患者设置120和控制程序122产生电流脉冲形式的刺激。电极选择模块126将所产生的脉冲切换到电极阵列150的一个或多个适当电极,以将电流脉冲递送到一个或多个所选电极周围的组织。测量电路128被配置为捕获由电极选择模块126选择的在电极阵列的一个或多个感测电极处感测的神经响应的测量。
图3图解地示出了植入的刺激器100与神经180(在这种情况下为脊髓)的相互作用,然而替代性实施例可以邻近任何期望的神经组织定位,包括外周神经、内脏神经、副交感神经或脑结构。电极选择模块126选择电极阵列150的刺激电极2来将电流脉冲递送到包括神经180的周围组织,并且还选择阵列150的回路电极4用于刺激电流恢复以保持零净电荷转移。
向神经180递送适当的刺激引起包括复合动作电位的神经反应,其将如所示的沿着神经180传播,用于治疗目的,在用于慢性疼痛的脊髓刺激器的情况下,治疗目的可能在理想位置产生感觉异常。为此,刺激电极用于以30Hz递送刺激。为了装配该装置,临床医生施加刺激,该刺激产生用户体验为感觉异常的感觉。当感觉异常在与受疼痛影响的用户身体区域一致的位置并且尺寸一致时,临床医生为正在进行的用途指定配置。
装置100还被配置为感测沿着神经180传播的复合动作电位(CAP)的存在和强度,无论这样的CAP是否由来自电极2和4的刺激诱发,或者以其他方式诱发。为此,阵列150的任何电极可以由电极选择模块126选择以用作测量电极6和测量参考电极8。由测量电极6和8感测的信号被传递到测量电路128,测量电路128例如可以根据本申请人的国际专利申请公开号WO 2012155183的教导进行操作,其内容通过引用并入本文。
然而,本发明认可,感觉异常的经历是否是持续疼痛减轻所必需的,这是不清楚的。虽然感觉异常通常不是令人不快的感觉,但是在提供疼痛缓解而不产生感觉的刺激方案中可能有益处。
轴突中动作电位产生的阈值遵循如图4所示的强度持续时间曲线。随着刺激的脉冲宽度增加,轴突达到阈值所需的电流减小。基强度电流是渐近值,是即使在非常长的脉冲宽度下也不能产生动作电位的最大电流。然后将时值定义为在两倍于基强度电流的电流下激发动作电位所需的最小脉冲宽度。
图5示出了递送高频脉冲序列对强度持续时间曲线的影响。如所示,高频脉冲群可以有效地作为相对激活神经具有更长脉冲宽度的单个脉冲。也就是说,当与具有相同脉冲宽度的宽间隔刺激相比时,紧密间隔的刺激可以有效地相加并且募集额外的纤维群体。刺激可以去极化轴突膜至阈值并产生动作电位,或者它们可以去极化轴突膜电位至恰低于阈值并且不产生动作电位。当轴突响应于刺激产生动作电位时,其不能在称为不应期的一段时间内产生第二电位。另一方面,响应于第一刺激未达到阈值的那些轴突可以在随后的刺激中达到阈值,因为它们的膜电位随着每一次刺激不断增高至接近阈值,条件是下一个刺激在膜电位从先前的刺激中恢复之前发生。这种效应在少数高频刺激下平衡,并且当与在低频下相同脉冲宽度的单个刺激相比时,可以导致所募集的纤维的数量的有效倍增。
背柱中的Aβ纤维的活化可以响应于姿势的变化而显著变化。这个姿势影响主要是由于刺激电极相对于该纤维的运动。姿势的变化可以通过记录诱发复合动作电位(ECAP)来测量。姿势的瞬时变化,例如打喷嚏或咳嗽,可产生诱发CAP的幅度增加10倍或更多因子。图6显示了个体在多种不同姿势下的幅度生长曲线。它示出了当患者从一种姿势换到另一种姿势时募集阈值的显著变化,当用户仰卧时,征募阈值几乎低至0.5mA,当用户俯卧时约为3mA。
图7显示了对应于单个姿势的背柱激活的强度持续时间曲线。对应于ECAP的阈值的电流相对于脉冲宽度。例如,35μs的脉冲宽度对应于11.5mA的阈值电流。注意到图6的募集曲线,当坐着的患者换到仰卧位置时,图7中的阈值可以预期下降到该值的三分之一,这说明,对于35μs的脉冲宽度,该阈值将是11.5/3=3.83mA。为了响应于姿势的改变而保持阈值,可以增加脉冲宽度,或者如前所述,可以使用采用较短脉冲宽度的高频群。
本发明进一步认可,皮肤感觉受到运动和感觉输入的抑制,抑制的水平取决于运动或感觉输入的强度,并且运动诱导的抑制减弱颤动和压力。对于缓慢、中等和快速运动,压力感觉的减少分别为30%、38%和79%。通常,感觉输入显示掩蔽现象,其中大刺激的存在可以掩蔽对较小刺激的感知。这甚至可能发生在较小的刺激出现在较大的刺激之前(前向掩蔽)时。这种现象发生在皮肤输入期间。
因此,本发明的第一实施例提供一种脊髓刺激系统,其具有检测运动的能力,并且仅在运动足够强以便掩蔽由电刺激产生的感觉期间施加或增加电刺激。这样的系统针对植入的个体实现了疼痛的缓解但没有感觉的产生,这是由于受试者在静止时感知的感觉低于在运动期间感知的阈值的事实。
存在可以检测个体的运动的多种方式。一种方法是使用加速度计(其感测刺激器的运动),另一种方法是使用由于脊髓硬膜外腔中的运动而改变的电极阵列的阻抗。用于检测运动的第三种方法是使用诱发复合动作电位的调制。已经开发了闭环神经调制系统,其使用复合动作电位的记录以实现恒定的募集,例如像国际专利公开WO 2012155183和WO2012155188中所述,其内容通过引用整体并入本文。已经显示ECAP的幅度随着姿势的变化而敏感地变化。因此,幅度可以用于检测运动和与那些运动一致的突发刺激的递送时间。ECAP的测量提供了一种取决于姿势直接评估脊髓背柱中的募集水平的方法。用于检测运动的另一种方法(其也适用于检测感觉输入)是监测没有被神经刺激器诱发的神经上的神经活动,例如像本发明人的澳大利亚临时专利申请号2014904595中所描述的方法,其内容通过引用并入本文。此类非诱发的神经活动可以由传出运动信号或传入感觉或本体感觉信号产生,这提供了可以发生掩蔽的机会,并且因此限定增加的刺激剂量的递送可能是适当的时间。
本实施例中的算法运算如下。在患者静止的情况下建立ECAP的次级感觉异常幅度的反馈控制。通过监测刺激电流来检测运动,刺激电流被不断地调节以保持恒定的ECAP响应。为随着时间的变化的幅度建立设定点,当达到该设定点时表示改变刺激参数的足够快速的运动。电流的变化可能不足以满足用于检测足够大的运动(如在图8中的时间段P1中发生的)的标准或者其可以满足或超过该标准(如在图8中的时间段P2中发生的)。
在检测到这种变化时,通过调节刺激参数来设置新的刺激条件。刺激参数可以是影响背柱纤维的募集的那些中的任何一个,例如幅度、脉冲宽度、刺激频率或其组合。刺激器在新设置下输出刺激群一段时间。还可以在反馈回路中控制输出,使得实现恒定的募集水平。调整刺激增加的周期的定时,使得其在与检测到的运动相一致的短时间内停止,并且在运动停止之前终止,使其不被个体感知到。
定时和幅度可以通过多种方式设置,例如施加固定时间的固定幅度(与测量的ECAP或运动的幅度成比例地调节并且在固定间隔之后终止的幅度),或变化之后的刺激和终止的固定幅度(即ECAP幅度随时间的一阶导数)下降。注意在达到变化的设定水平时调节刺激参数。因此,可以通过反馈来调节固定的ECAP幅度,当所施加的电流的一阶导数最后下降到低于设定电平时,该反馈被终止。
在递送刺激群之后,系统恢复到低于感知阈值的刺激模式,以监测姿势中的进一步变化,并且重复该序列。刺激参数的调节可以随着时间(上升和下降)或其他时变函数进行控制。
不旨在受理论限制,SCS的当前假定的作用机制基于背侧柱中的Aβ纤维活性,其通过突触传递导致GABA(一种抑制性神经递质)在背角中释放。GABA然后减少宽动态范围神经元的自发活动,并且从而产生了疼痛缓解。GABA介导的抑制的动力学是未知的,但是存在来自SCS的后切断效应,其在一些患者中可以延长相当长时间。这表明GABA的积累在短时间内是可能的,这将导致更长期的疼痛抑制。如果GABA释放的量子与刺激成比例,则有益的是将紧张连续刺激与较高频率刺激的爆发比较。连续紧张刺激在60Hz的刺激频率下在一个小时的周期内提供216000次刺激,而在1.2kHz下,在三分钟内可以实现相同数量的刺激的递送。如上所述对刺激递送进行控制,则在一小时内3分钟的活动将产生与紧张刺激递送的相同数量的超阈值刺激。因此,较高频率的刺激爆发可以与紧张刺激一样有效,但是具有短得多的刺激延续时间。
ECAPS的使用允许在白天施加到接受者的剂量被小心地控制,并且如果刺激的数量下降到实现最佳治疗所需的目标水平以下,则可以应用额外的刺激。因为个体不够活跃,或者因为系统设定点未被最佳地调整,这可能发生。给定这样的条件,系统可以警告用户或临床医生或者甚至恢复到紧张连续超阈值刺激的周期。
在一些实施例中,应用的治疗刺激可以是用于神经激活的超阈值刺激,然而在其他实施例中,可以应用亚阈值刺激于其他治疗领域中的心理物理感知。
如上所述的ECAP测量可以用作计时疼痛缓解刺激的施加以与检测到的运动一致的方法。还可以使用多种其他方法,包括对患者自身的非诱发性神经活动的测量。图9显示了患者静止时的ECAP记录的实例,并且图10显示了患者在现场行走时的ECAP记录。
在图9和图10中,由于紧随患者在现场行走的刺激之后的非诱发的活动,噪声的幅度存在显著差异。简单的目视检查显示,在图9中的时间周期15-20秒期间,神经活动幅度通常小于5微伏,而在图10中的相同时期,神经活动幅度通常超过10微伏。许多自动化技术可以用于确定非诱发的神经活动的幅度。可以通过确定响应的最大值和最小值直接测量幅度,或者可替代地可以在窗口上确定RMS(均方根)。
可以在不输出刺激的情况下连续地测量非诱发的活动。以这种方式,可以连续地评估个体的活动或运动的程度,使得足够快速的运动可以被检测到并且用作增加刺激定量给予的触发原因。
图11a显示了从患者测量的非诱发的活动,并且显示了经历一定范围的运动活动(从摩擦腿到在现场行走和咳嗽)的个体的RMS非诱发的活动。如在图中明显的,当患者活动并在现场行走时,RMS信号大得多。图11b是从患者测量的非诱发的神经活动的另一个图示,并且显示了个体的RMS非诱发性活动,其中1102是个体不运动,1104是摩擦他们的腿,1106是在坐着时抬起一条腿,并且1108是步行。具体地,图11b显示了在1104处摩擦腿的感觉输入以及在1106处抬起腿的动作和/或本体感觉输入,其中每个都与在1102处所示的没有运动的期间略微不同,并且本发明的一些实施例被具体配置为解决这个问题。
在一个实施例中,利用非诱发的活动的算法操作如下:
i.植入物系统监测非诱发的活动(N),直到达到活动的阈值测量(Tnn)。
ii.在达到阈值时,产生刺激,并且在任何诱发反应结束后,重新测量刺激后非诱发的活动的量级(Ns)。
iii.以速率(Rs)计的刺激产生,直到非诱发的活性(Ns)下降到点刺激停止的活动的第二阈值测量值(Tns)以下。Tns通常取比Tnn更小的值,如此选择以提供合适程度的滞后。
iv.然后植入系统继续监测非诱发的活动,并返回到步骤(i)。
刺激速率(Rs)可以是固定速率,或者也可以被设置为随着非诱发的活动的量级而变化。
诱发活动的幅度可以用于控制在反馈回路中的每个连续的刺激产生的刺激的幅度,例如已经在国际专利公开号WO 2012155188中描述的。以这种方式采用反馈回路的优点是在积极运动的时段期间保持ECAP幅度恒定,在积极运动期间已知其显著变化。
能以下面的方式确定该算法的参数
i.使用对处于静息的患者连续刺激的传统方法为患者制定计划。调整刺激位置和幅度以获得疼痛全部区域的感觉异常覆盖。记录获得疼痛缓解的ECAP(Ea)的幅度。
ii.关闭刺激并测量非诱发的活动的范围。设置阈值Tnn,使得其高于患者静息时的非诱发的活动的基线。
非诱发的活动的存在是个体的运动和/或感觉输入的结果。运动还影响诱发的活动的幅度,因此如果诱发的活动由反馈回路控制,则设置为保持恒定幅度的电流或其他刺激参数的变化可以用于监测运动的变化并设置用于停止刺激的点。
通过仅在检测到运动和/或感觉输入的时间递送增加的刺激,本发明提供了显著降低的功率预算。例如,如果每15秒检测一次运动,并且所递送的刺激包括5次刺激,则与每分钟1200次刺激的连续的20Hz的刺激方案相比,系统将递送每分钟20次刺激,即减少98.3%的刺激。
图12a示出了背柱激活的阈值1210,随着时间变化,该阈值例如会随着姿势变化而变化。在时间1222、1224处,该阈值1210下降到刺激水平1230以下。本发明可以在这些周期1222、1224期间在如图12b所示的整个周期或例如在如图12c所示的周期的开始和/或结束时启动或增加刺激方案。应当注意,每个受影响的纤维也将以相应的方式发生响应,尽管取决于电极距该纤维的距离以及用户运动使纤维进入电极的有效刺激范围内的时间,响应发生在略微不同的时间里。在图12b中递送的递送刺激1240、1242包括在10kHz、40μs脉冲宽度和2mA幅度下的高频刺激的突发。这样的刺激被配置成在各自的时间段1222和1224期间实现阻滞,因此在图12b中,在每个时间段1222、1224中仅产生单个动作电位1250、1252,然后在剩下的各自时间期间纤维被阻滞。
在图12c中,应用替代的刺激方案,其中仅在阈值交叉点处施加刺激,这些阈值交叉点是用户实际上从一种姿势运动到下一姿势的时刻。根据本发明的第一方面,刺激序列1260、1262、1264、1266在运动期间递送增加的刺激剂量,因此在此类时刻诱发了增加数量的动作电位1270。该实施例认可,在运动期间,与当个人不运动时施加相同的刺激相比,感知的心理物理学可导致个体感觉到来自给定刺激的感觉减少。然而,递送大剂量的刺激的益处在刺激结束后会保持一段时间。
图13示出了可以由刺激1240、1242产生的在阻滞期间记录的神经电压。可以看出,刺激的高频序列的周期小于动作电位1302的周期。因此,当序列的第一刺激产生动作电位1302时,每个随后的刺激改变神经组织的膜电位,而不引起神经组织的去极化也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送。
图14-17示出了动作活动检测器1410的操作,其通过分析观察到的由施加的刺激1430诱发的神经反应1450来检测患者1440的运动。由检测器1410执行的算法使得仅在记录到与运动相关的缓慢脊髓电位时递送刺激,否则禁止刺激。运动相关的脊髓电位在本实施例中被定义为大于200μVP-P的信号,针对导线位置标准化,带宽在1到30Hz之间。
检测器1410的一个目标是精确地检测与疼痛发生区域相关联的具体肢体或身体部分的运动,例如,对于腿部的疼痛,检测器1410力图检测行走、抬腿等。检测器1410还被配置成足够快地检测运动,以此在运动仍在发生时能够开始刺激。检测器1410也被参数化,因此可以使算法为具有变化的刺激参数的患者工作。
检测器1410通过随时间施加刺激序列并在每个刺激之后获得神经反应幅度测量值来操作。在图15中的1502处绘制在30秒的过程中以这种方式获得的神经反应幅度的序列。在此期间,患者在现场行走。神经反应信号1502被低通滤过、差分和整流,以产生经整流差分的神经反应信号1504。微分器允许早期检测到运动,并且整流器确保捕获到负信号和正信号两者。梯度值m[n],即信号1504然后被馈送到具有以下等式的包络检测器:
参数α是一个介于0和1之间的值。更接近于1的值将导致更缓慢的包络延迟,并且因此在每次检测之后导致刺激被施加更长的一个时间段。从差分信号1504以上述方式产生的包络1506在图15中示出。检测器输出1508从包络1506阈值化,其中检测器输出值1导致施加刺激,而输出0禁止刺激传递。如在该实施例中可以看到的,检测器输出1508因此使刺激仅在检测到运动时被选择性地递送。
调节阈值和参数α允许调节刺激定量给予。例如,图16和17示出了在各种患者运动期间的算法输出,其中参数引起了比在图15中的1508中所见的更小或更稀疏的刺激周期。
活动检测器的其他实施例还可以提供指示运动的幅度的运动幅度输出,其可以用于调制刺激的幅度或持续时间或其他刺激参数。
可以看出,图14-17的实施例对于患者正在行走的时期是有效的。图18示出了另一个实施例,该实施例进一步操作以适当地检测感觉输入,例如摩擦腿。在该实施例中,检测器通过随时间施加一系列刺激并在每个刺激之后获得神经反应幅度测量来操作。在图18中的1802处绘制在大约30秒的过程中以这种方式获得的神经反应幅度的序列。在进入测量的约19秒之前,以及在测量1802的约39秒之后,患者是不活动,如1822所指示的。在1824时间段期间,患者摩擦了他们的腿。周期1822和1824之间的信号1802的差异是相当微小的,然而腿部摩擦的感觉输入提供了利用掩蔽的优点在周期1824期间递送刺激的机会。因此,本实施例被配置为分析测量信号1802并且区分感觉输入1824的周期与不活动的周期1822。
为了实现这个目标,图18的实施例获得60Hz下的神经测量1802。每个测量或样本x[n]被保存到由检测窗口长度参数N定义的长度的循环缓冲区。采用以下公式,使用每个新样本更新运动平均值:
双样本运动平均值有利于最小化处理时间。接下来,从循环缓冲区中的所有样本并且采用上述移动平均值,计算信号1802的方差1804:
方差1804,var[n]然后被馈送到具有以下等式的包络检测器:
参数α是一个在0和1之间的值,并且可以被调整,由此较小的值将导致刺激在初始检测之后被施加更长的时间。包络检测器的输出在图18中的1806处示出。
检测器输出1808通过与阈值1810相比较从包络1806阈值化来产生,其中检测器输出值1导致施加刺激,而输出零禁止刺激递送。可以调整阈值以适合给定的硬件和/或给定的患者。如在该实施例中可以看到的,检测器输出1808因此使刺激仅在感觉输入发生的时候被选择性地递送。具体地,在该实施例中,检测器输出1808适当地禁止在1822期间的刺激,同时充分利用在1824期间由腿摩擦提供的掩蔽机会来递送增加剂量的刺激,尽管在不活动期1822和腿部摩擦期1824之间信号1802略有微小差异。
本领域技术人员应理解,在不偏离广泛描述的本发明的精神或范围的情况下,可以对如具体实施例所示的发明做出众多的变化和/或修改。因此,现有的这些实施例在所有方面都被认为是说明性的而非限定性或限制性的。
Claims (28)
1.一种施加治疗性神经刺激的计算机实现的系统,该系统包括:
用于监测用户的感觉输入和运动中的至少一个的模块;和
用于响应于感觉输入和用户运动中的至少一个的检测,在对应于检测到的感觉输入或用户运动引起对由所述治疗性神经刺激产生的感觉的掩蔽的持续时间的时间段内递送增加的刺激剂量的模块,该增加的刺激剂量被配置为引起增加的神经募集。
2.根据权利要求1所述的系统,其中该增加的刺激剂量由增加刺激幅度、刺激脉冲宽度和/或刺激频率中的一个或多个来实现。
3.根据权利要求2所述的系统,其中该增加的刺激剂量包括高频刺激的突发。
4.根据权利要求1至3中任一项所述的系统,其中当既没有检测到感觉输入也没有检测到运动时,刺激以减少的剂量递送。
5.根据权利要求1至3中任一项所述的系统,其中当既没有检测到感觉输入也没有检测到运动时,不递送刺激。
6.根据权利要求1至3中任一项所述的系统,进一步包括监测递送给所述用户的累积刺激剂量,并且使用所述累积刺激剂量作为基础来限定在运动期间或没有运动期间所需的刺激方案,以设法递送期望的总刺激剂量。
7.根据权利要求4所述的系统,进一步包括监测递送给所述用户的累积刺激剂量,并且使用所述累积刺激剂量作为基础来限定在运动期间或没有运动期间所需的刺激方案,以设法递送期望的总刺激剂量。
8.根据权利要求5所述的系统,进一步包括监测递送给所述用户的累积刺激剂量,并且使用所述累积刺激剂量作为基础来限定在运动期间或没有运动期间所需的刺激方案,以设法递送期望的总刺激剂量。
9.根据权利要求1-3和7-8中任一项所述的系统,其中通过测量神经通路上的神经活动来检测所述用户的感觉输入和运动中的至少一个。
10.根据权利要求9所述的系统,其中所测量的神经活动包括由施加到神经通路的电刺激产生的诱发的神经反应。
11.根据权利要求10所述的系统,其中当从给定刺激诱发的神经反应中检测到变化时,检测到运动。
12.根据权利要求9所述的系统,其中所测量的神经活动包括非诱发的神经活动。
13.根据权利要求10所述的系统,其中所测量的神经活动包括非诱发的神经活动。
14.根据权利要求11所述的系统,其中所测量的神经活动包括非诱发的神经活动。
15.根据权利要求1-3、7-8和10-14中任一项所述的系统,其中所述用户的运动由加速度计检测。
16.根据权利要求1-3、7-8和10-14中任一项所述的系统,其中递送该增加的刺激剂量的时间段被预先定义为一秒的量级。
17.根据权利要求1-3、7-8和10-14中任一项所述的系统,其中递送该增加的刺激剂量的时间段是通过执行检测所述用户的感觉输入或运动的停止的进一步步骤来适应性地确定,并且继而停止递送该增加的刺激剂量。
18.根据权利要求1-3、7-8和10-14中任一项所述的系统,其中该增加的刺激剂量在所述时间段内的选定时刻递送。
19.一种用于施加治疗性神经刺激的装置,该装置包括:
至少一个电极,该电极被配置为沿着用户的神经通路定位;以及
控制单元,该控制单元被配置为监测所述用户的感觉输入和运动中的至少一个,并且被配置为在对应于所检测到的感觉输入或用户运动引起对由所述治疗性神经刺激产生的感觉的掩蔽的持续时间的时间段内经由所述至少一个电极递送增加的刺激剂量,该增加的刺激剂量被配置为引起增加的神经募集。
20.一种用于实现神经阻滞的计算机实现的系统,该系统包括:
用于向神经组织递送电刺激序列的模块,每个刺激以一定水平配置,由此至少在刺激电极与神经组织的给定相对位置处,序列的第一刺激产生动作电位,并且由此每个随后的刺激改变神经组织的膜电位而不引起神经组织的去极化,也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送,使得刺激序列将膜电位维持在动作电位的传导被阻止或防止的可变范围内。
21.根据权利要求20所述的系统,其中通过施加超阈值刺激的序列来实现所述阻滞,其中第一刺激将引起动作电位。
22.根据权利要求20所述的系统,其中所述阻滞通过施加在第一姿势中是亚阈值但在用户运动到第二姿势时变为超阈值的刺激序列来实现。
23.根据权利要求20至22中任一项所述的系统,其中所述刺激序列以大于500Hz的频率递送。
24.根据权利要求23所述的系统,其中所述刺激序列以大于1kHz的频率递送。
25.根据权利要求24所述的系统,其中所述刺激序列以5-15kHz范围内的频率递送。
26.根据权利要求20-22和24-25中任一项所述的系统,其中标称亚阈值刺激水平由临床医生在为用户装配植入刺激器时预先设定。
27.根据权利要求26所述的系统,其中所述标称亚阈值刺激水平通过不时地重复确定所述神经组织的募集阈值来适应性地确定。
28.一种用于实现神经阻滞的装置,该装置包括:
至少一个电极,该电极被配置为沿着用户的神经通路定位;以及
被配置为向神经组织递送电刺激序列的控制单元,每个刺激以一定水平配置,由此至少在电极与神经组织的给定相对位置处,序列的第一刺激产生动作电位,并且由此每个随后的刺激改变神经组织的膜电位而不引起神经组织的去极化,也不诱发动作电位,每个随后的刺激在神经组织的膜电位从先前刺激恢复之前递送,使得刺激序列将膜电位维持在动作电位的传导被阻止或防止的可变范围内。
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CN103842022A (zh) * | 2011-05-13 | 2014-06-04 | 萨鲁达医疗有限公司 | 用于控制神经刺激-e的方法和设备 |
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