CN109561849B - 伪像减少的神经刺激 - Google Patents

伪像减少的神经刺激 Download PDF

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CN109561849B
CN109561849B CN201780050628.4A CN201780050628A CN109561849B CN 109561849 B CN109561849 B CN 109561849B CN 201780050628 A CN201780050628 A CN 201780050628A CN 109561849 B CN109561849 B CN 109561849B
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迪安·卡兰托尼斯
彼得·斯科特·瓦尔莱克·辛格
黄恺
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Abstract

一种神经刺激，包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者。第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，并且对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像。这样进而可以用于独立地控制矢量检测器的相关性延迟与伪像矢量为不平行的或正交的。

Description

伪像减少的神经刺激
相关申请的交叉引用
本申请要求于2016年6月24日提交的澳大利亚临时专利申请号2016902492的权益，其通过援引并入本文。
技术领域
本发明涉及神经刺激，具体地涉及一种方法和装置，被配置用于以产生数量减少的伪像的方式递送神经刺激，以便利于对由神经刺激诱发的神经反应进行记录的任务。
背景技术
电神经调节用于或被设想用于治疗包括慢性疼痛、帕金森病以及偏头痛的多种病症并且恢复诸如听觉功能和运动功能之类的功能。神经调节***将电脉冲施加到神经组织上以便产生治疗效果。这类***通常包括植入的电脉冲发生器以及电源，电源是例如可以通过经皮感应传输而可再充电的电池。电极阵列连接至脉冲发生器，并且被定位在感兴趣的(多条)神经通路附近。通过电极被施加到神经组织上的电脉冲引起神经元去极化，这样产生了逆向的、顺向的或两者皆有的传播动作电位以实现治疗效果。
当例如被用于缓解慢性疼痛时，将电脉冲施加到脊髓的背柱(DC)上并且将电极阵列定位在背侧硬膜外腔中。以这种方式对背柱纤维进行刺激抑制了疼痛从脊髓中的那一段传导至大脑。
通常，在神经调节***中产生的电刺激触发了神经动作电位，所述神经动作电位则具有抑制或兴奋效果。抑制效果可以用于调节诸如疼痛传导等不期望过程，或者兴奋效果可以用于引起诸如肌肉收缩或刺激听觉神经等所期望效果。
在大量纤维之中产生的动作电位相加形成复合动作电位(CAP)。CAP是来自大量单一纤维动作电位的反应的总和。当对CAP进行电记录时，测量值包括大量不同的纤维去极化的结果。传播速度在很大程度上由纤维直径决定，并且对于如在背根进入区(DREZ)中以及背柱附近发现的大的有髓纤维而言，速度可以超过60ms-1。由一组相似纤维放电产生的CAP被测量为所记录的电位中的正峰P1，然后是负峰N1，随后是第二正峰P2。这是在动作电位沿单独的纤维传播时激活区域经过记录电极而产生的，从而产生了典型的三峰反应分布图。依据刺激极性和感测电极构造，一些CAP的测量分布图可以具有相反的极性，具有两个负峰和一个正峰。
本申请人在国际专利公开号WO 2012/155183中描述了被提出用于实现神经测量的方法，其内容通过援引并入本文。
为了更好地理解神经调节和/或其他神经刺激的效果，并且例如为了提供通过神经反应反馈进行控制的刺激器，期望准确地检测和记录由刺激所引起的CAP。当诱发反应晚于伪像出现时、或者当信噪比足够高时，对诱发反应进行检测不太困难。通常将伪像限制在刺激后1-2ms的时间，并且因此如果在这个时间窗口之后检测神经反应，则可以更容易地获得反应测量值。这是在刺激电极与记录电极之间有较大距离(例如对于神经以60ms-1传导而言大于12cm)外科手术监测中的情况，使得从刺激部位到记录电极的传播时间超过2ms。
然而，为了表征来自背柱的反应，需要高刺激电流以及电极之间极为靠近。类似地，任何植入的神经调节装置必须要有紧凑的尺寸，使得对于这类用于对所施加的刺激的效果进行监测的装置，(多个)刺激电极和(多个)记录电极必须极为靠近。在这类情况中，测量过程必须直接克服伪像。然而，这可能是一项艰巨的任务，因为在神经测量中观察到的CAP信号分量通常将具有微伏范围内的最大振幅。相比之下，被施加用于诱发CAP的刺激通常是几伏特并且导致电极伪像，这在神经测量中表现为部分地或全部地与CAP信号同期产生的几毫伏的衰减输出，从而呈现出对感兴趣的小得多的CAP信号进行隔离、甚至检测的显著阻碍。
例如，为了在存在输入5V刺激的情况下以1μV的分辨率解析10μVCAP，例如，需要动态范围为134dB的放大器，这在植入***中是不切实际的。由于神经反应可以与刺激和/或刺激伪像同期发生，所以CAP测量提出了测量放大器设计的一个困难的挑战。在实践中，电路的许多非理想方面导致了伪像，并且由于这些非理想方面大多具有可能是正极性或负极性的衰减指数表观，所以其识别和消除可能是费力的。
当试图将在植入装置中实施CAP检测时，这种问题的难度进一步加剧。典型的植入物具有功率预算，所述功率预算允许有限数量(例如数百或小数千个)的每个刺激的处理器指令，以便维持所期望的电池寿命。因此，如果用于植入装置的CAP检测器有规律地使用(例如一次一秒)，则必须考虑到检测器应该仅消耗功率预算的一小部分。
戴利(Daly)(US 8,454,529)建议施加刺激之后接着施加补偿脉冲，然而戴利的双相刺激和补偿脉冲一起并不是电荷平衡的并且因此导致净电荷在装置与组织之间转移。
已经包括在本说明书中的对文献、行动、材料、装置、物品等的任何讨论仅仅是为了提供本发明的背景的目的。不应由于其存在于本申请的每项权利要求的优先权日之前而将其视为承认任何或所有这些事项形成现有技术基础的一部分或者是与本发明相关的领域中的公知常识。
贯穿本说明书，词语“包括(comprise)”或诸如“包括(comprises)”或“包括(comprising)”的变化形式应被理解为暗指包含所陈述的一个要素、整体或步骤或一组要素、整体或步骤，但不排除其他任何一个要素、整体或步骤或一组要素、整体或步骤。
在本说明书中，要素可以是选项列表中的“至少一者”的陈述应被理解为所述要素可以是所列出的选项中的任何一项，或者可以是所列出的选项中的两项或更多项的任意组合。
发明内容
根据第一方面，本发明提供了一种诱发并检测神经反应的方法，所述方法包括：
施加刺激以诱发神经反应，所述刺激包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者，其中，第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像；
使用所述记录电极来获得所述神经反应的记录；以及
利用矢量检测器来检测所述记录中的所述神经反应；
其中，所述矢量检测器的相关性延迟以及所述刺激的第一电荷和第三电荷具有使所产生的伪像矢量与诱发神经反应矢量不平行的值。
根据第二方面，本发明提供了一种用于递送神经刺激的可植入装置，所述装置包括：
电极阵列，所述电极阵列包括至少一个标称刺激电极和至少一个标称记录电极；以及
处理器，所述处理器被配置用于使所述至少一个标称刺激电极施加刺激以诱发神经反应，所述刺激包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者，其中，第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像，所述处理器进一步被配置用于使所述至少一个标称记录电极获得所述神经反应的记录，所述处理器进一步被配置用于利用矢量检测器来检测所述记录中的所述神经反应；
其中，所述矢量检测器的相关性延迟以及所述刺激的第一电荷和第三电荷具有使所产生的伪像矢量与诱发神经反应矢量不平行的值。
根据第三方面，本发明提供了一种用于递送神经刺激的非瞬态计算机可读介质，包括在由一个或多个处理器执行时致使以下进行的指令：
施加刺激以诱发神经反应，所述刺激包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者，其中，第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像；
使用所述记录电极来获得所述神经反应的记录；以及
利用矢量检测器来检测所述记录中的所述神经反应；
其中，所述矢量检测器的相关性延迟以及所述刺激的第一电荷和第三电荷具有使所产生的伪像矢量与诱发神经反应矢量不平行的值。
本发明的第一到第三方面认识到，适当地调节或选择第一电荷与第三电荷之间的不等性或占空比可以使伪像矢量与诱发神经反应矢量不平行、更优选地是基本上正交的，使得伪像对于矢量检测器的输出的贡献经过零点，由此显著地改进了对诱发神经反应的观察。
本发明的一些实施例可以利用第一电荷与第三电荷之间的不等性或占空比的静态预定值以及矢量检测器的相关性延迟的静态预定值。然而，其他实施例可以适应性地调节刺激占空比和/或相关性延迟以便在伪像贡献中找出零点。这类适应性实施例提供了一种对减少在记录中观察到的伪像进行反复的或连续的优化的手段。
在刺激分量包括刺激相并且刺激是三相刺激的实施例中，第一电荷优选地超过第三电荷。在这类实施例中，第一电荷优选地在第二电荷的0.51倍与0.99倍大小之间，更优选地在第二电荷的0.6倍与0.9倍大小之间，更优选地在第二电荷的0.65倍与0.8倍大小之间，并且最优选地是第二电荷的约0.75倍大小。
第一到第三方面的实施例可以利用任何合适的矢量检测器。根据本申请人的国际专利公开号WO 2015074121的教导，矢量检测器可以例如利用四叶或五叶匹配滤波器模板，所述专利申请的内容通过援引并入本文。替代性地，产生信号输出的检测器可以利用替代性匹配滤波器模板、例如两叶或三叶匹配滤波器模板，所述叶是正弦分布图的或者与合成的或实际测得的复合动作电位分布图的两个或三个叶匹配或以其他方式相配地成形。
本发明的一些实施例认识到，虽然对检测器相关性中的延迟τ进行调节允许诱发反应矢量以进行所期望的对齐(例如，如关于WO 2015074121的图7所描述的)，但是单独调节三相刺激的第一相与第三相之间的不等性或占空比允许独立控制伪像矢量，使得伪像矢量可以被控制成与诱发反应矢量不平行地发生，并且更优选地使得伪像矢量被控制成与诱发反应矢量在很大程度上或基本上正交地发生。
在一些实施例中，至少三个刺激分量是通过两个刺激电极递送的两极刺激的时间刺激相。附加地或替代性地，至少三个刺激分量可以包括通过三个刺激电极递送的两相三极刺激的空间刺激极，本文描述的每个刺激极表示相应的刺激电极与周围组织之间电荷转移。
在本发明的第一到第三方面的一些实施例中，刺激也许不是电荷平衡的，并且可以通过替代性手段来恢复净电荷差，例如通过使一个或多个电极短路以在适当的时间接地来被动地恢复电荷差。
根据第四方面，本发明提供了一种递送神经刺激的方法，所述方法包括：
递送具有第一极性的第一刺激相和第三刺激相；
在所述第一刺激相之后并且在所述第三刺激相之前，递送具有与所述第一极性相反的第二极性的第二刺激相；
其中所述第一相到第三相是电荷平衡的，并且其中所述第一刺激相递送第一电荷，所述第一电荷不等于由所述第三刺激相递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便产生减少的伪像。
根据第五方面，本发明提供了一种用于递送神经刺激的可植入装置，所述装置包括：
电极阵列，所述电极阵列包括至少一个标称刺激电极和至少一个标称感测电极；以及
处理器，所述处理器被配置用于使所述至少一个标称刺激电极递送具有第一极性的第一刺激相和第三刺激相、并且在所述第一刺激相之后且在所述第三刺激相之前递送具有与所述第一极性相反的第二极性的第二刺激相，其中所述第一相到第三相是电荷平衡的，并且其中所述第一刺激相递送第一电荷，所述第一电荷不等于由所述第三刺激相递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在所述至少一个标称感测电极处产生减少的伪像。
根据第六方面，本发明提供了一种用于递送神经刺激的非瞬态计算机可读介质，包括在由一个或多个处理器执行时致使以下进行的指令：
递送具有第一极性的第一刺激相和第三刺激相；
在所述第一刺激相之后并且在所述第三刺激相之前，递送具有与所述第一极性相反的第二极性的第二刺激相；
其中所述第一相到第三相是电荷平衡的，并且其中所述第一刺激相递送第一电荷，所述第一电荷不等于由所述第三刺激相递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便产生减少的伪像。
可以通过使第一刺激相和第三刺激相具有不相等电流振幅和/或不相等持续时间和/或不相等形态而使第一电荷与第三电荷不相等。
在本发明的第四到第六方面的实施例中，峰间检测器可以用于对记录进行处理。虽然无论第一电荷与第三电荷之间的占空比是多少峰间检测器都不会经过零点，但是对第一电荷与第三电荷之间的占空比进行适当的调节允许找到检测器输出的最小值，因而提供一种在记录中产生减少的伪像的手段。
在替代性实施例中，第一到第六方面的所描述的刺激可以在缺乏任何相关ECAP记录时被递送，例如以便保存所期望的电组织条件直至以后可能需要进行ECAP测量的时间。
附图说明
现在将参照附图对本发明的实例进行描述，在附图中：
图1示意性地展示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是展示了植入的刺激器与神经的相互作用的示意图；
图4展示了根据本发明的一些实施例的具有不等相持续时间的三相刺激的电流分布图；
图5示意性地展示了将刺激递送至神经组织；
图6和图7展示了改变检测器时间延迟和三相刺激占空比的效果；
图8展示了可变化的三相占空比的实验性测试的结果；
图9示出了三相刺激的峰间伪像；
图10-11展示了人类受试者测试中出现的改进的伪像减少；
图12展示了本发明的一些实施例的具有不等相持续时间的概念化；
图13展示了根据本发明的其他实施例的具有不等相振幅的三相刺激的电流分布图；
图14a和图14b分别展示了根据本发明的另一个实施例的空间电极构造和三极刺激；
图15展示了根据本发明的另一个实施例的四相刺激的推导和最终形式；并且
图16展示了对刺激波形和/或构造进行优化以便使伪像最小化的过程。
具体实施方式
图1示意性地展示了植入的脊髓刺激器100。刺激器100包括植入在患者下腹部区域或臀后上区域中的合适的位置处的电子器件模块110、以及植入在硬膜外腔内并且通过合适的引线连接至模块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。此外，植入的神经装置100起到数据收集的作用，其中所收集的数据被传送至外部装置192。
图2是植入的神经刺激器100的框图。模块110包括电池112和遥测模块114。在本发明的实施例中，可以通过遥测模块114使用任何合适类型的经皮通信190，例如红外(IR)传输、电磁传输、电容传输和电感传输，以在外部装置192与电子器件模块110之间传输功率和/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而产生电流脉冲形式的刺激。电极选择模块126将所生成的脉冲切换至电极阵列150中的适当的(多个)电极，用于将电流脉冲递送至所选的(多个)电极周围的组织。测量电路128被配置成用于捕获由电极选择模块126在电极阵列中选择的(多个)感测电极处感测到的神经反应的测量值。
图3是展示了植入的刺激器100与神经180(在这种情况下是脊髓)的相互作用的示意图，然而替代性实施例可以定位在包括末梢神经、内脏神经、副交感神经或大脑结构的任何所期望的神经组织附近。尽管其他实施例可以附加地或替代性地递送两相三极刺激，但是电极选择模块126选择电极阵列150的刺激电极2以将三相电流脉冲递送至包括神经180的周围组织。电极选择模块126还选择了阵列150的返回电极4用作使电流恢复以维持零净电荷转移的刺激。
向神经180递送适当的刺激诱发了神经反应，所述神经反应包括如展示的沿神经180传播的复合动作电位，用于可能会在所需位置处产生感觉异常的在用于慢性疼痛的脊髓刺激器的情况下的治疗目的。为此目的，刺激电极用于递送30Hz的刺激。为了配合所述装置，临床医生施加刺激，所述刺激产生了让使用者体验为感觉异常的感觉。当感觉异常所处的位置和大小与使用者身体受疼痛影响的区域一致时，临床医生指定该构型用于当前使用。
装置100进一步被配置成用于感测沿着神经180传播的复合动作电位(CAP)的存在和电学分布图，无论这样的CAP是由来自电极2和4的刺激诱发还是以其他方式诱发。为此，阵列150中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。刺激器的实例还可以用作测量或参考电极或刺激电极。由测量电极6和8感测到的信号被传送到测量电路128，所述测量电路例如可以根据本申请人的国际专利申请公开号WO2012155183的教导进行操作，所述专利申请的内容通过援引并入本文。本发明认识到，在例如图3中示出的情况中，其中记录电极靠近刺激的部位，刺激伪像呈现出显著地阻碍获得复合动作电位的准确记录，但是可靠的准确CAP记录是一系列神经调节技术的关键推动者。
为此目的，本发明的本实施例提供了以使伪像减少的方式递送这种神经刺激，所述方法基于三相和/或三极刺激波形。图4展示了用于在本发明的一些实施例中实施本发明的合适的三相刺激400的总体电流分布图。刺激400分别在第一相和第三相中递送Q1和Q3的正电荷转移。在第二相中递送Q2的负电荷转移。根据本发明，刺激400是电荷平衡的，使得|Q2|＝Q1+Q3。根据本发明，Q1≠Q3，其中以使伪像最小化的方式选择Q1和Q3的相应值。这是通过以相同的量级I、但以不同的持续时间递送所有三个相来实现的。在本实施例中，第一相的持续时间是第二相的持续时间的0.75倍，使得Q1＝0.75Q2。第三相的持续时间是第二相的持续时间的0.25倍，使得Q3＝0.25Q2。发明人已经确定的是，第一相与第三相的电荷比为0.75:0.25被证明是针对Q1和Q3、甚至是在不同装置与不同人类受试者之间的特别稳健的设定。然而，第一相和第三相的占空比可以通过将参数考虑为0<α<1(α≠0.5)、或在优选实施例中0.5<α<1来进行调节，由此根据本发明Q1＝αQ2，并且Q3＝(1-α)Q2.。刺激400的相间间隙均可以在持续时间中进行调节或者可以省略。
图5示意性地展示了将刺激400递送至神经组织。在第一实施例中，通过控制器116使用点积检测器以在本申请人的国际专利公开号WO 2015074121中披露的方式来处理由电极6和8观察到的神经反应信号，所述专利申请的内容通过援引并入本文。有益地，这类实施例认识到，点积检测器产生的输出根据伪像和检测器的相对相位可以是正的或负的。如图6和图7中所示并且特别是如在WO 2015074121中关于所述公开的图7更全面地描述的，检测器时间延迟τ的变化影响了所观察到的神经反应矢量的相位角。本发明进一步认识到，刺激400的占空比α的变化影响了由检测器输出测得的伪像的相位角。因此，参数τ和α提供对神经反应矢量相位角和伪像矢量相位角的独立控制，允许如图7所示地对有待寻找的两个矢量进行正交定位。
图8展示了人类受试者中的可变三相占空比的实验性测试的结果，如在阵列的四个不同电极上观察到的。参数α从0.1变化到0.9(在图8中示出为x轴上的百分比)，对所产生的三相刺激进行递送，并且如在WO 2015074121中描述的通过点积检测器来处理四个电极的每个电极上的所观察到的神经反应。在图8中标绘点积检测器的输出。应当注意的是，通过使用点积检测器产生的伪像的测量由将会产生相同输出的等效ECAP的峰间值构成。图8揭示了如果70％的正向刺激处于第一相中(即如果α＝0.7)，则对于所有电极而言伪像约为零。此外，这个结果显示出其自身可以非常稳健地对抗引线型变化、以及其他刺激参数。替代性实施例当然可以适当地选择不同的α值以补偿不同的硬件或固件设定或者在患者之间需要的时候进行选择。
在第二实施例中，通过控制器116使用峰间检测来处理由电极6和8观察到的神经反应信号。峰间检测器可以仅产生伪像的正值。图9示出了根据第一脉冲与第三脉冲的比值的三相刺激的峰间伪像。再次，针对阵列的四个不同的感测电极进行观察以产生图9的四个轨迹。
当与具有0％的占空度(α＝0)的两相波形进行比较时，预期图9的图形外推将会产生至少40μV的伪像。因此，占空比可变的三相刺激在范围0.2<α<0.7中产生波谷，这在一些场景中可能是有帮助的。然而，这个波谷只比峰值低几个dB并且因此相比于图8的实施例值更低。
本发明的一些实施例的进一步的具体优势是，参数α是与减少伪像的其他方法正交的并且因此可以与这类其他方法结合使用。这些其他方法包括基于线性度的方法，例如交替相位和减法。
伪像减小的交替相位方法依赖于方程A(I)＝-A(-I)，其中A(I)是电流I时的伪像。因此A(I)+A(-I)＝0，所以在响应于单相的第一刺激获得的连续神经反应测量之后，是相反相位的可以通过减去连续获得的反应测量值来减小伪像的刺激。
伪像减少的减影方法还依赖于线性度。A(I)＝2.A(I/2)。因此，伪像减少还可以通过获得响应于一个振幅的第一刺激以及双倍振幅的第二刺激的连续神经反应测量值来实现，并且A(I)-2A(I/2)＝0。
线性度方法可以提供约20dB的伪像排除。在常规神经调节中，两相刺激中通常用于产生诱发反应。所述两相刺激产生相比于刺激具有固定极性的伪像，所以使刺激的极性反转使得伪像的极性反转。这样导致交替相位刺激，其中连续刺激的平均值导致消除伪像电压，而不是消除ECAP。这样是起作用的，但具有其自身的问题，例如ECAP尺寸减小、多重刺激部位等，或者较慢的有效刺激率，意味着每个治疗刺激的耗电量更高。
本发明的方法可以附加地或替代性地与基于检测的伪像减少方法组合，如在WO2015074121中描述的并且在图6-8的实施例中利用的。这些方法使用四叶检测器来清除伪像的泰勒展开式中的DC、线性和二次项。检测方法提供了约16dB的伪像排除。
本文描述的可变三相方法在与这类其他伪像减少技术组合使用时已经显示出提供另外13dB的伪像排除。将会注意到的是，这些方法彼此正交，即它们可以结合使用。期望这样将会提供20+16+9dB＝42dB的伪像排除。这样可以将在脊髓刺激患者中观察到的(通常较大的)500uV的伪像减少到相当于5uV的ECAP。
在又另一个实施例中，参数α可以随时间或基本上连续地适应性地验证并且在需要的时候进行调节。在这类实施例中，在一半治疗电流下递送三相刺激，这样允许***在没有任何诱发ECAP的情况下对检测器输出处的伪像进行测量。这样允许***动态调节占空度以在伪像中找到空值，针对特定情况进行优化。这样还允许在募集阈值以下递送相反相位三相刺激，以便经由线性度技术来提供用于消除的相反相位信号。
虽然图8的实施例利用了在WO 2015074121中描述的4叶匹配滤波器模板，但是应注意到的是，本发明的替代性实施例可以使用任何合适的点积检测器，包括2叶和3叶匹配滤波器点积检测器。在某些情况下，这类实施例甚至可能是优选的，因为与4叶点积检测器相比它们可以更好地排除白噪声或非伪像噪声。
图10-11展示了利用图8的实施例从具有脊髓刺激器的单个人类受试者获得的数据。在图10a中可以看出，当受试者坐着时在获得的神经测量值中观察到的伪像在6mA刺激电流下通过根据本发明的三相刺激而显著减少。图10b示出了对于相同人类受试者的三相(1002)和两相(1004)刺激，针对0-8mA的变化的输入刺激电流而绘制的观察到的神经反应幅度。在约6mA以下，没有诱发复合动作电位并且观察到的信号仅包括伪像，两相刺激的结果明显地更差(更大)，然后是根据本发明的占空比经调节的三相刺激的结果。此外，通过施加的刺激来诱发复合动作电位所超过的刺激阈值是大多数神经调节应用的临界参数。刺激阈值明显地表现为是本发明提供的在约6mA刺激电流的曲线图1002中的拐点，但是在两相结果1004中进行辨别非常困难或甚至是不可能的。另外，刺激阈值以上的增长曲线斜率，即在许多神经调节应用中的另一个临界参数，在曲线图1002中受到噪声的影响比在曲线图1004中小的多。
图11a和图11b对应于图10，是当受试者仰卧时获得的数据。再次，显著的伪像减少明显地通过本发明的占空比经调节的三相刺激来提供。
不受理论的限制，如图12中所示，三相刺激可以比作或概念化为两个连续的两相刺激。所以伪像应该是单独的刺激的伪像的电学总和。由于时间延迟(t1-t2),如果伪像波形是从相等的两相刺激中产生的，则所述伪像波形没有消除。本发明可以被认为是给出具有不相等的脉冲宽度和/或不相等的振幅和/或任何其他合适的特征的不等性的两个两相波形，采用的方式是使得正向和负向伪像贡献a1和a2的尺寸在创建时不相等，但旨在一旦时间延迟(t1-t2)提供了a1的一些衰退则使其消除。
图12中示出的其中第二相被设想为没有相间间隙的持续时间不相等的两个相位的可变比值的三相刺激的概念化提示了也在本发明的范围内的另一组实施例。在这类实施例中，引入相间间隙以将第二相有效分成两个相。因此这类实施例包括具有多于三个相的刺激波形。在四相刺激的情况中，在这类实施例中通过每个相被递送的电荷可以例如分别被配置成α、-α、-(1-α)、+(1-α)，如在图12中直接提示的。然而，使用四相允许通过各相被递送的电荷具有其他变化，使得更普遍地通过各相被递送的电荷可以分别包括+XμC、-YμC、-ZμC和+(Y+Z-X)μC，各相通过其相间间隙与相邻相临时分开，每个相间间隙是任何合适的值，并且这类实施例处于本发明内，只要是对α、X、Y和Z的值进行选择以便实现所需的电荷平衡以及记录电极经历的伪像减少。
考虑又另一个实施例，如图13中所示，应注意的是，调节波形的振幅而不调节脉冲宽度也提供了有待产生的合适的三相波形。与图12相似，图13的刺激波形可以被看做将具有相反伪像的两个两相波形的总和。通过调节振幅a和b，在将(a+b)保持在所需电荷下以实现所期望的治疗效果时，将会期望两个子分量的伪像项以图12所示的方式消除。
应理解的是，在另外其他实施例中，图13的不等相振幅方式可以与图4和图12的不等相持续时间振幅方式组合。
在另外其他实施例中，可以按图14a和图14b所示的方式施加三极刺激。如图中14a所示，电极的空间定位可以如图14b中所示的通过适当地配置电流脉冲而被利用。电极2和3上的波形将具有极性相反的伪像。再次，通过调节振幅a和b，同时将(a+b)保持在所需电荷时，将会期望在空间上消除某一点处两个子分量的伪像项，并且可以被配置成用于优先地消除记录电极的已知的附近位置处的伪像。
图15展示了本发明的原理的应用以便产生根据本发明的另一个实施例的又另一个刺激波形。在本实施例中，四相刺激由两个分量制成；正向第一两相脉冲、以及包括长相间间隙的负向第一两相脉冲。正向第一两相脉冲分量影响神经刺激。负向第一两相脉冲分量不提供刺激，因为其不诱发任何神经反应。然而负向第一两相脉冲引入被第二相控制的伪像，这样当适当地选出所有四个相的相对电荷时，以图12中所示的相应方式消除从正向第一两相分量中产生的伪像。
图16展示了对刺激波形和/或构造进行优化以便使伪像最小化的过程1600。在1610中，在神经募集的阈值以下施加刺激以便确保神经反应不被诱发并且不对测量有贡献。在1620中，测量并且记录由刺激导致的伪像。在1640中，调节第一刺激分量与第三刺激分量之间的比值，并且重复步骤1610和1620达所期望的次数，以便探索第一与第三刺激分量之间的比值的所期望的范围。例如，比值可以按0.01的增量从0调节到1。一旦1630确定了已经找到第一刺激分量与第三刺激分量之间的比值的所希望的范围，所述过程进行到步骤1650，在此从所有记录中标识出伪像的最小值。产生最小伪像的比值接着被用于在阈值以上的治疗水平上的当前刺激。相似的方式可以用于确认任何或所有刺激分量(例如通过对应相和/或通过对应电极以单极、两极、三极或多于三个极的刺激构型在无论递送单相、两相、三相或多于三相刺激时所递送的电荷)的最佳比，和/或可以用于识别刺激相振幅、刺激相宽度、以及刺激脉冲形状的最佳比。过程1600或其合适的改编可以被装置192执行或控制以在静态基础上确认这类最佳比，例如在植入后装置编程阶段期间，或仅在临床输入场合下。替代性地，过程1600或其合适的改编可以在预编或提示基础上被控制器116执行或控制，而不需要装置192或任何临床医生介入，以便在动态或持续的基础上在装置的整个操作中的合适时刻确认这类最佳比。用于执行过程1600的这类合适时间可以是每个装置110检测改变的刺激条件、例如植入物接受者的姿势改变的时机。
要求保护并且描述的电子功能可以通过安装在印刷电路板上的分离部件、或通过集成电路的组合、或通过专用集成电路(ASIC)来实施。
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。例如，虽然图4展示了通过修改第一相和第三相的持续时间来调节三相占空比，这类调节可以附加地或替代性地受到修改相电流振幅的影响。此外，三相刺激可以如示出的包括矩形相或可以包括正弦分布图、阶梯式、三角形或任何其他合适轮廓的相。虽然已经讨论了一系列三相、三极以及四相刺激，应理解的是本发明的所描述的原理可以改编并且施加以配制具有大量相或极的刺激，然而所述刺激实现减小伪像的目的并且这类刺激也在本发明的范围内，并且特别地本文限定的第一刺激分量被理解为包含在多相刺激的其他分量之后暂时出现的刺激分量，并且本文限定的第三刺激分量被理解为包含可以在第一刺激分量之前、同时或之后出现的刺激分量。此外，第一刺激分量和第三刺激分量如本文限定的进一步被理解为包含具有零个、一个或更多个物理地或暂时地***在第一刺激分量与第三刺激分量之间的其他刺激分量的刺激分量。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制性或约束性的。

Claims (15)

1.一种用于递送神经刺激的可植入装置，所述装置包括：
电极阵列，所述电极阵列包括至少一个标称刺激电极和至少一个标称记录电极；以及
处理器，所述处理器被配置用于使所述至少一个标称刺激电极施加刺激以诱发神经反应，所述刺激包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者，其中，第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像，所述处理器进一步被配置用于使所述至少一个标称记录电极获得所述神经反应的记录，所述处理器进一步被配置用于利用矢量检测器来检测所述记录中的所述神经反应；
其中，所述矢量检测器的相关性延迟以及所述刺激的第一电荷和第三电荷具有使所产生的伪像矢量与诱发神经反应矢量不平行的值，其中，所述相关性延迟是时间延迟。
2.如权利要求1所述的可植入装置，其中，所述第一电荷与第三电荷之间的不等性使所述伪像矢量与所述诱发神经反应矢量正交。
3.如权利要求1所述的可植入装置，其中，所述处理器还被配置成适应性地调节所述刺激的占空比和/或相关性延迟以便在伪像贡献中找到零点。
4.如权利要求2所述的可植入装置，其中，所述处理器还被配置成适应性地调节所述刺激的占空比和/或相关性延迟以便在伪像贡献中找到零点。
5.如权利要求1-4中任一项所述的可植入装置，其中，所述刺激分量包括刺激相。
6.如权利要求5所述的可植入装置，其中，所述第一电荷在第二刺激电极递送的第二电荷的0.6倍与0.9倍大小之间。
7.如权利要求6所述的可植入装置，其中，所述第一电荷是所述第二电荷的0.75倍大小。
8.如权利要求1-4和6-7中任一项所述的可植入装置，其中，所述矢量检测器利用多叶匹配滤波器模板。
9.如权利要求5所述的可植入装置，其中，所述矢量检测器利用多叶匹配滤波器模板。
10.如权利要求8所述的可植入装置，其中，所述处理器还被配置成调节所述矢量检测器的相关性延迟τ以便对齐所述诱发神经反应矢量。
11.如权利要求9所述的可植入装置，其中，所述处理器还被配置成调节所述矢量检测器的相关性延迟τ以便对齐所述诱发神经反应矢量。
12.如权利要求1-4、6-7和9-11中任一项所述的可植入装置，其中，所述至少三个刺激分量包括由至少三个刺激电极递送的三极刺激的空间刺激极。
13.如权利要求5所述的可植入装置，其中，所述至少三个刺激分量包括由至少三个刺激电极递送的三极刺激的空间刺激极。
14.如权利要求8所述的可植入装置，其中，所述至少三个刺激分量包括由至少三个刺激电极递送的三极刺激的空间刺激极。
15.一种用于递送神经刺激的非瞬态计算机可读介质，包括在由一个或多个处理器执行时致使以下进行的指令：
施加刺激以诱发神经反应，所述刺激包括至少三个刺激分量，每个刺激分量包括时间刺激相和空间刺激极中的至少一者，其中，第一刺激分量递送第一电荷，所述第一电荷不等于由第三刺激分量递送的第三电荷，对所述第一电荷和所述第三电荷进行选择以便在记录电极处产生减少的伪像；
使用所述记录电极来获得所述神经反应的记录；以及
利用矢量检测器来检测所述记录中的所述神经反应；
其中，所述矢量检测器的相关性延迟以及所述刺激的第一电荷和第三电荷具有使所产生的伪像矢量与诱发神经反应矢量不平行的值。
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