CN107614055A - 脑神经刺激器电极装配 - Google Patents
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Abstract
装配脑神经刺激器电极阵列包括:将至少第一电极定位在第一大脑半球中的希望的靶结构中,并且将至少第二电极定位在对侧大脑半球中的对应的靶结构中。将来自所述第一电极的电刺激施加到所希望的靶结构上。记录在所述第二电极处观察到的、响应于所述电刺激的神经反应。参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配。
Description
相关申请的交叉引用
本申请要求于2015年5月31日提交的澳大利亚临时专利申请号2015902021的权益,其通过援引并入本文。
技术领域
本发明涉及一种脑内神经调节,具体涉及一种用于监测由于刺激而产生的脑内活动的方法以便优化脑深部刺激器(DBS)电极阵列的植入和/或优化植入的DBS阵列的术后装配。
背景技术
神经调节涉及将电刺激施加到生物组织上以产生治疗效果。神经调节可以是非侵入性的,诸如通过经皮神经电刺激(TENS)、经颅磁刺激(TMS);或当需要植入一个或多个电极并控制刺激器时是高度侵入性的,如在脑深部刺激(DBS)的情况下。DBS已经成为对晚期帕金森病的最有效的治疗,但是是一种高度侵入性的疗法:需要将两根引线深深植入小脑皮层下核并连接到胸部中植入的一个或多个脉冲发生器上。许多DBS电极靶结构已经被研究用于治疗多种多样的疾病,并且所述电极的优选位置取决于正治疗的疾病。在帕金森病的情况下,优选的靶是苍白球(GPi)的内段和丘脑底核(STN)。对于亨廷顿病和抽动秽语综合征,也以Gpi为靶,对于慢性抑郁和酒精依赖,以伏隔核为靶,并且对于阿尔茨海默病,以穹隆、下丘脑、以及Meynert基底核为靶。
帕金森病是一种影响黑质中的多巴胺释放细胞的退行性疾病。已经提出了许多描述基底神经节的功能以及这种退变与帕金森病如何相关的理论,然而,所有这类理论在描述帕金森病的所有方面具有明显不足,并且理解DBS机制仍是大量研究工作的焦点。
对DBS机制和基底神经节的理解不足的重要原因在于难以测量神经组织对刺激的直接反应。大多数发现是基于对传出结构的单细胞测量,并且直至最近,仍无法充分测量靶结构的直接复合反应,因为当记录接近于刺激部位时,大伪影(电或电极伪影)容易掩饰组织反应。
就此而论,植入DBS电极阵列典型地涉及通过立体定向术将所述阵列插入靶结构中,以便将所述电极阵列定位或实际装配在三维坐标所限定的位置。然而,鉴于患者之间在解剖学或神经学上的不同、以及每个电极触头相对于感兴趣的神经结构的相对较大的尺寸,立体定向术定位一般不会优化治疗效果或使刺激功率最小化。相应地,在手术植入之后,装置装配将典型地进一步包括通过试错法来临床探究刺激参数、并选择阵列中的电极和产生最佳治疗效果的刺激参数。
本说明书中已经包括的文献、行动、材料、装置、物品等等的任何讨论唯一地用于提供本发明的背景的目的。不应因为它在本申请的每项权利要求的优先权日之前存在就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是与本发明相关的领域中的公知常识。
贯穿本说明书,“包括(comprise)”一词或变化形式(例如“包括(comprises)”或“包括(comprising)”)应被理解为意指包括所陈述的要素、整体或步骤、或者要素、整体或步骤的群组,但不排除任何其他要素、整体或步骤、或者要素、整体或步骤的群组。
在本说明书中,要素可以是“选项清单中的至少一项”的陈述应被理解为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
根据本发明的第一方面,提供了一种用于装配脑神经刺激器电极阵列的方法,所述方法包括:
将至少第一电极定位在第一大脑半球中的希望的靶结构中;
将至少第二电极定位在对侧大脑半球中的对应的靶结构中;
将来自所述第一电极的电刺激施加到所希望的靶结构上;
记录在所述第二电极处观察到的、响应于所述电刺激的神经反应;并且
参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配。
根据本发明的第二方面,提供了一种脑神经刺激器装置,所述脑神经刺激器装置包括:
被配置成有待被定位在第一大脑半球中的希望的靶结构中的至少第一电极;
被配置成有待被定位在对侧大脑半球中的对应的靶结构中的至少第二电极;
被配置成用于将来自所述第一电极的电刺激施加到所希望的靶结构上的脉冲发生器;
被配置成用于记录在所述第二电极处观察到的、响应于所述电刺激的神经反应的测量电路;以及
用于参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配的处理器。
本发明还提供了一种计算机软件、或包括计算机程序代码工具的计算机程序产品、或非瞬态计算机可读介质、或在所述软件或产品的控制下运行的计算机装置,其被配置成用于将来自第一电极的电刺激施加到在第一大脑半球中的希望的靶结构上,并且进一步被配置成用于接收在位于对侧大脑半球中的对应的靶结构中的第二电极处观察到的、响应于所述电刺激的所记录的神经反应,并且用于参照所记录的神经反应来评估所述第一电极和第二电极的至少一者的装配。
所述神经刺激器可以包括脑深部刺激器。
所述靶结构可以包括丘脑底核。
因此,本发明提供了通过同侧刺激和对侧神经反应测量来执行的脑深部电极装配。本发明的一些实施例可以参照所记录的神经反应来装配所述第一电极,认识到:当同侧刺激电极植入到达所希望的位置(如STN的尾侧部分)时,所观察的对侧神经反应达到顶峰。附加的或替代性的实施例可以参照所记录的神经反应来装配第二电极,认识到:当对侧记录电极植入到达所希望的位置(如STN的尾侧部分)时,所观察的对侧神经反应达到顶峰。因此,可以在术中优化纵向定位和轴向定位,并且例如可以以交替的方式反复优化同侧电极定位和对侧电极定位。而且,在一些实施例中,可以通过颠倒第一电极和第二电极的作用的附加步骤来进一步优化电极装配,使得由所述第二电极来施加刺激而通过所述第一电极来记录神经反应。术后纵向电极选择、和/或轴向电极选择、和/或圆周电极选择也可以这样来执行。
根据本申请人的国际专利申请公开号WO2012/155183的教导优选地获得神经测量,其内容通过援引并入本文。
在评估第一电极到靶结构的装配时,本发明的一些实施例可以提供一种诊断方法。可以将对侧神经反应的存在、幅值、形态、和/或潜伏期与健康的范围进行比较和/或监测其随时间推移的变化以便诊断疾病状态。例如对侧反应的缺乏或异常状态可能指示半球间的神经连接问题,所述问题可能不是帕金森病的症状,但是可能诱发临床上可观察到的类似症状。因此,在一些实施例中,关于本发明提供的对侧反应形态的知识可以被用作除了仅靶向疾病以外的诊断工具,并且可以因此提供单独辨别无法通过所述疗法治疗的症状的能力、以及指导选择对DBS/左旋多巴疗法的补充疗法的能力。本发明的方法可以应用于一些实施例中以便确定刺激的治疗效果、确定药物的治疗效果、和/或监测疾病状态。随后,可以基于诊断,来订制、请求、和/或施予治疗反应。
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展示了植入的脑深部刺激器;
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脑组织的相互作用的示意图;
图4a-4f示出了对施加在一个半球上的刺激的同侧反应和对侧反应;并且
图5a-5f示出了对施加在相对的半球上的刺激的同侧反应和对侧反应。
具体实施方式
图1示意性地展示了植入的脑深部刺激器100。刺激器100包括被植入在患者胸部内的适合位置处的电子模块110、以及被植入脑内并且通过适合的引线连接到模块110上的两个电极组件150、152。植入的神经装置100的工作的许多方面可由外部控制装置(未示出)重新配置。而且,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递到外部装置。
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,遥测模块114可以使用任何合适类型的经皮通信,诸如红外(IR)传输、电磁传输、电容传输和电感传输,以在外部装置与电子模块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等等的相关联存储器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和152中的适当电极,以将电流脉冲递送到所选电极周围的组织。测量电路128被配置为捕获在电极选择模块126在电极阵列中选择的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的电极阵列150与神经组织180(在此情况下为丘脑底核)的相互作用的示意图,然而,替代性的实施例可以被定位成邻近任何适合的脑结构。阵列152未在图3中示出,但以相同的方式在对侧大脑半球中工作。电极选择模块126选择电极阵列150中的刺激电极2来将电流脉冲递送到周围神经组织180,并且还选择阵列150中的返回电极4用于刺激电流恢复以保持零净电荷转移。
将适当的刺激递送到神经组织180引起包括复合动作电位的神经反应,所述复合动作电位将沿着在同侧大脑半球和对侧大脑半球中的相关联神经路径传播以用于治疗目的。
装置100进一步被配置成用于感测在神经组织180内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的刺激引起、还是以其他方式例如被阵列152中的对侧电极引起。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。测量电极6和8感测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WO 2012155183的教导工作,所述专利申请的内容通过援引并入本文。
本发明认识到:可以在对侧大脑半球上观察到对正被刺激的同侧半球的神经反应。不旨在受理论限制的情况下,这表明在对侧STN中看到的对侧反应是由正被刺激的同侧STN的大多尾侧部分突入相对的大脑半球中引起。
本发明进一步认识到:这样的对侧反应观察结果可以用于在以STN为靶时优化所述引线中的任一引线或两根引线的放置。相应地,在这个实施例中,电极150和152的手术放置是如下地进行的。首先,使用立体定向术将这两根引线150和152植入其近似的位置中。然后,在同侧引线150上递送刺激,同时在对侧引线152上记录。由外科医生对同侧引线渐进地再定位,递送进一步的刺激,并且监测所观察的对侧反应的振幅。当同侧刺激电极150理想地定位在STN深部时,通过在所述对侧的引线152观察到的对刺激的反应达到最大值。因此,对于刺激引线,通过移动引线150并经由引线152观察对侧上的反应以辨别对侧反应的最大值,从而优化引线150的放置,这时所述同侧电极可以被视为理想地定位。
然后,可以通过反转引线152和150的角色并重复以上步骤来调整对侧的第二引线152的放置。而且,当那个电极是记录电极时,可以改进任一个或两个电极的位置;当所述记录电极向理想位置移动时,观察到的反应将被最大化。
图4a-4f示出了对给定刺激的同侧反应和对侧反应。具体地,图4a和图4b展示了在同侧电极E3和E4上观察到的、响应于在同侧电极E1和E2上递送的不同振幅的刺激的同侧反应,其中,电极E1-E4全部是由引线150携带的,E1在同侧STN中插入得最深,而E4在其中插入得最浅。图4c-4f展示了在由对侧引线152携带的电极E5至E8上观察到的对侧反应,E5在对侧STN中插入得最深,而E8在其中插入得最浅。
值得注意的是,在图4c-4f中,在对侧上观察到的反应同时发生并且在E5至E8的任何之间不发生传播延迟。所述对侧反应的时机也与在同侧电极E4上、离刺激最远记录的同侧反应的时机大致重合。不旨在受理论限制的情况下,可能认为:从E1/E2处的刺激原点到同侧引线上的最远电极E4所采取的路径与从E1/E2到对侧上的电极E1-E4的神经通路具有大致相同的距离或延迟。
当电极阵列150和152保持在位时,阵列152(代替阵列150,如图4中的情况)也将刺激施加到相对半球上。图5a-5f示出了对施加在相对半球上的刺激的同侧反应和对侧反应。具体地,图5a-5d展示了在引线150的同侧电极E1至E4上观察到的、响应于在引线152的同侧电极E5和E6上递送的不同振幅刺激的对侧反应。再次,E1在对侧STN中插入得最深,而E4在其中插入得最浅。图5e和图5f展示了在由引线152携带的电极E7和E8上观察到的同侧反应,E5在同侧STN中插入得最深,而E8在其中插入得最浅。
图5示出了对侧效果是双向的,使得刺激和记录的作用可以从一个阵列到另一个阵列交替。图5a-5d示出了对侧反应再次与刺激振幅成比例地增长,并且再次同时发生。然而,在图5a-5d中看到的对侧反应展现出在图4c-4f中未看到的多峰形式。所述对侧反应的峰也不与同侧ECAP的峰对齐。因此,所述对侧反应的一些方面是片面的。应注意的是,获得了图4和图5的结果的患者呈现了片面的帕金森病强直性。此外,应注意的是,由于在各个半球中的不同传导速度,在对侧反应中可能有差异。如通过同侧刺激测量的,在传导速度最低的那侧,对侧反应也较慢地到达,这似乎解释了为何只在图5a-5d中看见第二峰。
关于脑中的电极位置和STN的寻靶存在若干个可用的自由度。这些包括电极阵列的深度、电极沿着所述阵列的位置(即,常规刺激电极中的1至4)、电极的取向、或从径向分布的电极阵列中的电极选择、以及电极阵列相对于STN的内侧-外侧轴线或背腹轴线的位置。根据本发明,可以优化或至少改进或监测任何或所有这些因素。
在植入完成后,也可以根据本发明来进行临床装配。DBS程序参数和电极选择的目标在于高效地激活产生最鲁棒的治疗效果的区域。STN的最尾侧部分已经被辨别出与运动功能相关并且因此DBS将以其为靶。因此,可以通过在当前技术的补充技术中查看对侧反应来实现对程序参数和电极放置的调整。使在STN中观察的对侧效应最大化对应于STN的同侧尾侧区段的最大刺激。
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制性或约束性的。
Claims (19)
1.一种用于装配脑神经刺激器电极阵列的方法,所述方法包括:
将至少第一电极定位在第一大脑半球中的希望的靶结构中;
将至少第二电极定位在对侧大脑半球中的对应的靶结构中;
将来自所述第一电极的电刺激施加到所希望的靶结构上;
记录在所述第二电极处观察到的、响应于所述电刺激的神经反应;并且
参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配。
2.如权利要求1所述的方法,其中,所述神经刺激器包括脑深部刺激器。
3.如权利要求2所述的方法,其中,所述靶结构包括丘脑底核。
4.如权利要求1至3中任一项所述的方法,其中,参照所记录的神经反应通过在所记录的神经反应中寻找最大值来装配所述第一电极。
5.如权利要求1至4中任一项所述的方法,其中,参照所记录的神经反应通过在所记录的神经反应中寻找最大值来装配所述第二电极。
6.如权利要求1至5中任一项所述的方法,其中,所述装配包括术中电极定位。
7.如权利要求1至7中任一项所述的方法,进一步包括:
将来自所述第二电极的进一步的电刺激施加到所述对侧大脑半球中的所述对应的靶结构上;
用所述第一电极记录来自所述靶结构的进一步的对侧反应;并且
参照所记录的进一步的对侧反应来评估所述第一电极和第二电极中的至少一者的装配。
8.如权利要求1至7中任一项所述的方法,其中,所述装配包括术后电极选择。
9.如权利要求1至8中任一项所述的方法,其中,评估所述装配包括将当前装配与过去装配进行比较以监测所述装配随时间推移的变化。
10.一种脑神经刺激器装置,包括:
被配置成有待被定位在第一大脑半球中的希望的靶结构中的至少第一电极;
被配置成有待被定位在对侧大脑半球中的对应的靶结构中的至少第二电极;
被配置成用于将来自所述第一电极的电刺激施加到所希望的靶结构上的脉冲发生器;
被配置成用于记录在所述第二电极处观察到的、响应于所述电刺激的神经反应的测量电路;以及
用于参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配的处理器。
11.如权利要求10所述的脑神经刺激器装置,其中,所述神经刺激器包括脑深部刺激器。
12.如权利要求11所述的脑神经刺激器装置,其中,所述电极被配置成有待被定位在丘脑底核中。
13.如权利要求10至12中任一项所述的脑神经刺激器装置,其中,所述处理器被配置成用于通过在所记录的神经反应中寻找最大值来装配所述第一电极。
14.如权利要求10至13中任一项所述的脑神经刺激器装置,其中,所述处理器被配置成用于通过在所记录的神经反应中寻找最大值来装配所述第二电极。
15.如权利要求10至14中任一项所述的脑神经刺激器装置,其中,所述处理器被配置成用于提供术中电极定位。
16.如权利要求10至15中任一项所述的脑神经刺激器装置,其中,所述处理器进一步被配置成用于:
将来自所述第二电极的进一步的电刺激施加到在所述对侧大脑半球中的所述对应的靶结构上;
用所述第一电极记录来自所述靶结构的进一步的对侧反应;并且
参照所记录的进一步的对侧反应来评估所述第一电极和第二电极中的至少一者的装配。
17.如权利要求10至16中任一项所述的脑神经刺激器装置,其中,所述处理器被配置成用于提供术后电极选择。
18.如权利要求10至17中任一项所述的脑神经刺激器装置,其中,所述处理器被配置成用于通过将当前装配与过去装配进行比较以监测所述装配随时间推移的变化来评估所述装配。
19.一种用于装配脑神经刺激器电极阵列的非瞬态计算机可读介质,所述计算机可读介质包括:
计算机程序代码工具,用于将来自位于第一大脑半球中的希望的靶结构中的第一电极的电刺激施加到所希望的靶结构上;
计算机程序代码工具,用于记录在对侧大脑半球中的对应的靶结构中的第二电极处观察到的、响应于所述电刺激的神经反应;以及
计算机程序代码工具,用于参照所记录的神经反应来评估所述第一电极和第二电极中的至少一者的装配。
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JP7071257B2 (ja) | 2022-05-18 |
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CA2983333C (en) | 2023-09-19 |
EP3302692A1 (en) | 2018-04-11 |
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