CN106390283A - 用于抑制疼痛,具有降低的副作用的选择性高频脊髓调节,以及相关的***和方法 - Google Patents
用于抑制疼痛,具有降低的副作用的选择性高频脊髓调节,以及相关的***和方法 Download PDFInfo
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Abstract
一种患者治疗装置,包括信号发生器,被编程为以频率范围从1.5kHz至100kHz的频率、幅值范围从0.5mA至10mA的幅值以及脉冲宽度范围从10微秒至333微秒的脉冲宽度引导电信号,该信号发生器具有被设置为和至少一个可植入的信号输送装置;以及至少一个具有近侧部分和远侧部分的可植入的、信号输送装置,该近侧部分被连接至该信号发生器并具有被设置为被连接至该信号发生器的连接器的连接部件,该远侧部分具有多个电接触以用于沿着患者脊髓传送该电信号至一个或多个硬脑膜位置,以通过该电信号的应用减少或抑制该患者的疼痛,该信号发生器被配置为引导该电信号且该电信号不产生患者感觉异常。
Description
对相关申请的交叉引用
此申请要求2009年5月8日递交的美国临时申请号61/176,868的优先权,其以参考方式被合并于此。此申请要求2009年4月22日递交的美国临时申请号61/171,790的优先权,其以参考方式被合并于此。
技术领域
本公开内容总体上涉及用于抑制疼痛,具有降低的副作用的选择性高频脊髓调节,以及相关的***和方法。
背景技术
神经刺激器已经被开发用于治疗疼痛,运动障碍,功能性障碍,强直,癌症,心脏性紊乱,以及其它各种医学症状。可植入的神经刺激***一般具有可植入的脉冲发生器和一个或多个引线,其输送电脉冲至神经组织或肌肉组织。例如,用于脊髓刺激(SCS)的若干神经刺激***具有圆柱形的引线,其包括环形截面形状的引线主体和一个或多个在该引线主体的远端彼此隔开的传导性的环。这些传导性的环作为个别的电极工作,并且在很多情况下这些SCS引线通过被***硬膜外腔中的大针被经皮植入,该过程可以用或者不用探针辅助。
一旦被植入,该脉冲发生器施加电脉冲至电极,其依次改变患者的神经***的功能,如通过改变患者对感觉刺激的响应性和/或患者的
运动-电路输出。在疼痛治疗中,该脉冲发生器施加电脉冲至电极,其随后可以产生感觉,该感觉掩蔽或者以其它方式改变患者的痛觉。例如,在很多情况下,患者报告麻刺感或感觉异常,其在感觉上比下伏的痛觉更舒适和/或较少不舒服。尽管许多患者是这种情况,但其他的许多患者可能报告有益效果和/或结果。相应地,仍有需要改进解除患者疼痛的技术和***。
发明内容
本发明的一实施例提供了一种患者治疗装置,包括:信号发生器,被编程为以频率范围从1.5kHz至100kHz的频率、幅值范围从0.5mA至10mA的幅值以及脉冲宽度范围从10微秒至333微秒的脉冲宽度引导电信号,该信号发生器具有被设置为和至少一个可植入的信号输送装置;以及至少一个具有近侧部分和远侧部分的可植入的信号输送装置,该近侧部分被连接至该信号发生器并具有被设置为被连接至该信号发生器的连接器的连接部件,该远侧部分具有多个电接触以用于沿着患者脊髓传送该电信号至一个或多个硬脑膜位置,以通过该电信号的应用减少或抑制该患者的疼痛,该信号发生器被配置为引导该电信号且该电信号不产生患者感觉异常。
附图说明
图1A是根据本公开的若干实施方式的被设置在脊柱以输送治疗信号的可植入的脊髓调节***的部分示意图。
图1B是患者的脊柱的横截面部分示意图,其显示了用于植入根据本公开的实施方式的引线主体的代表性的位置。
图2是柱状图,其示意了患者在四天周期的临床研究中的疼痛减少水平,在该期间,患者接受根据此公开的实施方式的治疗,将其与基准水平和常规的脊髓刺激装置实现的水平相比较。
图3是柱状图,其比较了在启动调节变化的临床研究期间患者根据本公开的实施方式接受治疗的次数,将其与患者接受常规脊髓刺激的数据相比较。
图4是柱状图,其示意了在临床研究期间获得的接受根据此公开的实施方式的治疗的患者的活动性能改善。
图5A是柱状图,其比较了在临床研究期间获得的患者执行各种活动的活动性能指标。
图5B和5C是柱状图,其示意了在临床研究期间获得的接受根据此公开的实施方式的治疗的患者的睡眠改善。
图6A是柱状图,其示意了在临床研究期间获得的接受根据此公开的实施方式的治疗的患者与调节位置有关的成功治疗结果。
图6B和6C是流程图,其示意了按照此公开的实施方式进行的方法。
图7A显示了按照此公开的实施方式在跟踪临床研究期间使用的引线布置。
图7B显示了按照此公开的实施方式接受治疗的患者在跟踪临床研究期间获得的结果。
图8是确定按照此公开的治疗的可能作用机制的示意图,将其与预期的常规脊髓刺激作用机制相比较。
图9是根据此公开的实施方式配置的引线主体的部分示意图。
图10A-10C是根据此公开的若干实施方式配置的可伸长的引线的部分示意图。
图11A-11C是根据此公开的若干实施方式配置的可伸长的多丝状引线的部分示意图。
具体实施方式
1.0 引言
本技术总体上涉及脊髓调节以及相关的***和方法,其用于通过具有高频率成分或组分(例如,具有高基本频率的部分)的波形抑制疼痛,其总体上具有被降低的或者被消除的副作用。这种副作用可以包括不需要的运动刺激或阻滞,和/或非靶标疼痛的感觉功能干扰。若干实施方式还提供了简化的脊髓调节***与元件,以及用于专业人员和/或患者的简化步骤。此公开的某些实施方式的细节被描述如下,并参照调节患者的一个或多个目标神经群(例如,神经)或位点的方法,以及相关的用于提供该调节的可植入结构。尽管如下描述的被选择的实施方式是参照对脊柱,背角,脊根,脊根入口区,和/或脊柱的其它特定区域进行调节以控制疼痛,该调节在有些情况下也可以涉及其它神经结构和/或脊髓的目标神经群和/或其它神经组织。一些实施方式可以具有和此部分描述不同的结构,组件或步骤,并且其它实施方式可以取消特定的组件或步骤。因此,本领域普通技术人员将了解,此公开可以包括其它具有添加元件的实施方式,和/或可以包括不具有如下参照图1A-11C所述的部分特征的其它实施方式。
一般而言,许多以下实施方式的方面涉及治疗作用的产生,其包括患者的疼痛减少。该治疗作用可以通过抑制,镇压,下调,阻滞,阻止,或者其它方式调节被作用的神经群的活动而被产生。在此公开的技术内容的许多实施方式中,治疗诱导的感觉异常不是实现疼痛减少的先决条件,其与标准的SCS技术不同。和现有的脊髓刺激治疗相比,如下参照图1A-11C所述的该技术预期可以产生更有效,更健康,较不复杂和/或其它的更受期待的结果。
图1A图示了用于减轻慢性疼痛和/或其它症状代表性的治疗***100,其相对于患者的脊髓191的总体解剖学布置。该***100可以包括脉冲发生器101,其可以被皮下植入患者190体内,并被连接至信号输送部件110。在代表性的例子中,该信号输送部件110包括引线或引线主体111,其具有在植入后向该患者190输送治疗的特征。该脉冲发生器101可以直接连接该引线111,或可以通过通信连接102(例如,延伸部)被连接至该引线111。相应地,该引线111可以包括一终段,其被可释放地连接到位于中断114处的延伸部(如图1A所示)。这可以容许单一类型的终段用于不同体型(例如,不同高度)的患者。在此处使用时,术语引线和引线主体包括任何负载装置装置要能够与向患者190提供治疗信号的适合的基质和/或支撑件。例如,该引线111可以包括一个或多个电极或电接触,其引导电信号进入患者的组织,以供患者解除。在其它实施方式中,该信号输送部件110可以包括非引线主体的装置(例如,叶片),其也引导电信号和/或其它类型的信号至该患者190。
该脉冲发生器101可以发送信号(例如,电信号)至该信号输送部件110,其上调(例如,刺激或激励)和/或下调(例如,阻滞或镇压)目标神经。在此处使用时,除非另外注明,术语“调节(动词)”和″调节(名词)″总体上指对目标神经具有上述效果中任意一种的信号。该脉冲发生器101可以包括机器可读取的(例如,计算机可读取的)介质,其包含用于生成和发送适合的治疗信号的指令。该脉冲发生器101和/或该***100的其它元件可以包括一个或多个处理器107,存储器108和/或输入-输出设备。相应地,可以通过包含于计算机可读取介质上的计算机可执行指令执行提供调节信号和执行其它相关功能的过程,例如,在该(多个)处理器107和/或(多个)存储器108处。该脉冲发生器101可以包括多个部分,元件,和/或子***(例如,用于按照多信号输送参数引导信号),其被包围于单一的外壳中,如图1A所示,或在多个外壳中。
该脉冲发生器101还可以接收和响应来源于一个或多个来源的输入信号。该输入信号可以引导或者影响的方式为,可以在其中选择,执行,更新和/或其它方式执行治疗指令。该输入信号可以来源于一个或多个传感器112(图1为了说明目的显示一个),其由脉冲发生器101携带和/或分布在该脉冲发生器101外部(例如,在其它的患者位点),而仍然和该脉冲发生器101连通。该传感器112可以提供取决于或者反映患者状态(例如,患者位置,患者姿势和/或患者活动程度)的输入,和/或与患者无关的输入(例如,时间)。在其它实施方式中,可以由患者和/或专业人员提供输入,下文对此有进一步细节描述。更进一步的细节被包括于2010年2月10日申请的共同未决的美国申请号12/703,683中,其以参考方式被合并于此。
在一些实施方式中,该脉冲发生器101可以从外接电源103获得能量以产生治疗信号。该外接电源103可以用电磁感应(例如,射频信号)发送能量至该植入的脉冲发生器101。例如,该外接电源103可以包括外部线圈104,其于相应的在该可植入的脉冲发生器101中的内部线圈(未示出)相联系。该外接电源103可以是便携式的,以便于使用。
在另一个实施方式中,除外接电源103之外,或者替代地,该脉冲发生器101可以从内部电源可以能量,以产生治疗信号。例如,该被植入的脉冲发生器101可以包括非可充电电池或可充电电池以提供这种能量。当该内部电源包括可充电电池时,外接电源103可被用于对该电池充电。该外接电源103可以相应从适合的电源(例如,常规的墙壁电源)被充电。
在一些情形下,在植入该脉冲发生器101之前,外部编程器105(例如,试验调制器)可以在初始的植入步骤期间被连接至该信号输送部件110。例如,专业人员(例如,医师和/或公司代表)可以使用该外部编程器105来改变被实时提供至该信号输送部件110的调节参数,并选择最佳的或特别有效的参数。这些参数可以包括该信号输送部件110的位置,以及被提供至该信号输送部件110的电信号的特性。在一个典型的步骤中,该专业人员用电缆组件120临时性将该外部编程器105连接至该信号输送装置110。该电缆组件120可以相应地包括被可释放地连接到该外部编程器105的第一连接器121,以及被可释放地连接到该信号输送部件110的第二连接器122。相应地,该信号输送部件110可以包括连接元件,以容许其被直接(如果它足够长)或间接(如果不够长)连接至信号发生器。该专业人员可以在起始位置测试该信号输送部件110的功效。然后该专业人员可以断开电缆组件120,复位该信号输送部件110,并再施加该电调节。可以反复进行此过程,直到该专业人员获得该信号输送装置110的期望位置。任选地,该专业人员可以移动该部分植入的信号输送部件110,无需断开该电缆组件120。适合的电缆组件方法和相关的技术的更多细节被描述于2009年9月18日申请的共同未决的美国申请号12/562,892中,其以参考方式被合并于此。如以下将进一步所述内容,本公开的特定方面可以有利地减少或消除上述反复过程。
用外部编程器105建立该信号输送部件110的位置和适当的信号输送参数后,该患者190可以通过该外部编程器105产生的信号接受治疗,一般持续有限的时间期间。在一个代表性的应用中,该患者190接受这种治疗一周。在此期间,该患者在身体外佩戴该电缆组件120和该外部编程器105。假定该试验性治疗有效,或显示出有效的征兆,则该专业人员用该植入的脉冲发生器101替换该外部编程器105,并用根据该试验期间获取的经验选择的参数对该脉冲发生器101编程。任选地,该专业人员还可以替换该信号输送部件110。一旦该可植入的脉冲发生器101已经被设置在该患者190体内,由该脉冲发生器101提供的信号输送参数仍然可以通过无线的医师的编程器(例如,医师的遥控器)111和/或无线的患者编程器106(例如,患者的遥控器)被遥控更新。总体上,该患者190能控制的参数比专业人员少。例如,该患者编程器106的能力被限制于启动和/或停止脉冲发生器101,和/或调节该信号幅度。
在任何上述实施方式中,该脉冲发生器101提供信号所按照的参数可以在部分该治疗方式期间被调整。例如,可以按照预定程序,患者和/或医师的输入,和/或随机或伪随机方式调整频率,幅度,脉冲宽度和/或信号输送位置。这种参数变换可被用于解除很多潜在的临床情形,包括患者的疼痛知觉变化,优选的目标神经群的变化,和/或患者顺应性或习惯的变化。
在本公开的特定实施方式中,上述***和方法的某些方面可以被简化或消除。例如,在至少一些情形下,该***输送的治疗信号可以产生对引线位置和信号输送参数(例如,幅度)比常规的刺激***不敏感得多的作用。相应地,如上所述,可以淘汰在该引线植入步骤期间用于确定适合的引线位置和相关信号输送参数的试错法过程(或此过程的部分)。除此种简化之外,或者替代地,还可以淘汰引线植入后的试验期。除上述简化之外,或者替代地,还可以在长期基础上明显简化选择信号输送参数和给予信号的过程。这些内容的进一步的方面及其它预期有益的结果被更详细地论述如下。
2.0 代表性的治疗参数
Nevro公司,本申请的受让人,已经进行了多位点临床研究,期间多个患者先用常规的脊髓刺激(SCS)技术处理治疗,然后用下位公开的新近发展的技术治疗。此研究有进一步的集中于新近发展的技术上的进一步的临床研究跟进,其证实并且扩充了在初步研究期间获得的结果。该新近发展的技术,治疗和/或***的多个实施方式被称为本公开的技术,治疗,和/或***,以上总称为本公开技术。
2.1.初始的比较研究
在初始临床研究之前,被选择患者被确定为遭受初级慢性下腰痛(例如,神经性的疼痛,和/或伤害性疼痛,和/或其它类型的疼痛,取决于患者),其可以是单独的,也可以和影响其它面积的疼痛联合,通常为该患者的(双)腿。在所有情形下,下腰痛是主要的。在该研究期间,这些患者被配备以两根引线,其各自以总体上类似于图1A所示的方式被植入脊髓区域。一根引线被植入在脊髓中线189的一侧,并且另一根引线被植入在该脊髓中线189的另一侧。图1B是该脊髓191和邻近的椎骨195(总体上基于Crossman和Neary的“Neuroanatomy”1995(Churchill Livingstone出版)的信息),以及在代表性的患者内植入引线110的位置的截面示意图。该脊髓191位于腹侧定位的腹面躯体196和背侧定位的横突198和棘突197之间。箭头V和D分别确定腹侧和背侧方向。该脊髓191本身位于该硬膜199内,其还包围部分伸出该脊髓191的神经,包括后根193和后根神经节194。该引线110被设置为在反向的横向上偏离该脊髓中线189(例如,偏移约1毫米),以使得这两根引线110彼此隔开约2毫米。
带有如图1B所示布置的引线110的患者初始具有被设置在椎骨T7-T8。此位置是典型的标准SCS用于治疗下腰痛的位置,因为它总体上的情形是,在下部(下方)椎骨水平标准的SCS治疗会产生不希望的副作用,和/或有效性较差。这种副作用包括不需要的肌肉激动和/或疼痛。一旦引线110被植入,该患者接受标准的SCS治疗持续五天期间。此治疗包括在低于1500Hz(例如60-80Hz),脉冲宽度100-200微秒,和100%作业周期的频率的刺激。该信号的幅度(例如,当前幅度)在约3mA至约10mA之间变化。该幅度在该植入步骤期间被初始建立。然后在该研究期间,由该患者按照所希望的基础变化该幅度,这对于标准SCS治疗是典型的。
患者完成该研究的标准SCS部分之后,即接受根据本公开技术的调节。这些技术的一个方面包括向下移动该引线110,以使其位于椎骨T9,T10,T11,和/或T12。该引线110复位后,该患者在约3kHz至约10kHz的频率接受治疗信号。特殊情况下,在8kHz,9kHz或10kHz施加该治疗。这些频率显著高于标准SCS的的相关频率,并且相应地,在这些及其它代表性频率(例如,从约1.5kHz至约100kHz)的调节在此暂且被称为高频调节。该调节总体上在约50%至约100%的作业周期被施加,该调节信号开启约1毫秒至约2秒期间,并且关闭约1毫秒至约1.5秒的期间。该被施加的脉冲宽度为约30-35微秒,并且该幅度总体上在约1mA至约4mA之间变化(额定约2.5mA)。在该初始的临床研究期间,根据上述参数的调节通常被施加于该患者约四天的时期。
图2-6A图示了根据上述参数测试患者获得的临床结果的概要。图2是柱状图,其示意了这些患者对于各种症状的可见模拟尺度(VAS)疼痛分值。图2所示的这些分值对应综合疼痛。如上所述,这些患者主要遭受下腰痛,并且相应地,单独下腰痛的疼痛记分大致和图2所示相同。每一个柱条表示在该研究的此部分中被涉及的多个患者报告的平均值。柱条201和202分别显示患者不使用药物的8.7的基准疼痛水平,以及使用药物的6.8的基准水平。在该研究的第零天接受引线植入,以及启动根据上述参数的高频调节后,患者报告疼痛平均值为约4.0,由柱条203表示。在后三天的过程中,(由柱条204-213表示)这些患者每天早上,中午和晚上在日记上记录疼痛级别,如图2中相应地被标记的柱条所示。此外,由当地中心研究统筹人在病例报告表(CRF)上记录疼痛级别,如图2中相应地被标记的柱条所示。在此期间,这些患者的平均疼痛分值逐步降低至报告的约2.2的最低水平(由柱条212和213表示)。
为比较目的,柱条214显示了同一患者在该研究早期接受标准SCS治疗的疼痛分值。柱条214显示标准SCS治疗的平均值疼痛值是3.8。和本公开治疗的结果不同,标准的SCS治疗倾向于在若干天的过程中产生相对平缓的患者疼痛。比较柱条213和214,临床结果显示,与标准的SCS治疗相比,本公开的治疗降低42%的疼痛。
其它疼痛指标显示总体上一致的结果。在Oswestry失能指数上,平均分值从54的基准值下降至33,其相当于从“严重失能”到“中等失能”。患者的整体改善分值在1(“大幅改善”)至7(“非常差”)的尺度上为1.9。
除了用本公开的治疗达到更多的疼痛解除之外,和标准的SCS治疗相比,患者经历的其它益处被进一步参照图3-5C描述如下。图3是柱状图,其示意了这些患者每天启动调节变化的次数。示意了标准SCS治疗(柱条301)和本公开的治疗(柱条302)的结果。患者启动的调节变化总体上在所施加的信号幅度范围内变化,并且由患者通过外部调制器或遥控器启动,如以上参照图1A所述。接受标准的SCS治疗的患者启动对信号输送参数的变化平均每天44次。该被启动的变化通常在患者变化位置,活动程度和/或活动类型,然后经历疼痛解除的减少和/或使人不愉快的,不舒服的,疼痛的,不需要的或出乎意料的来自该治疗信号时被触发。接受本公开的治疗的患者完全没有改变信号输送参数,除非基于专业人员的要求。特别地,这些患者没有改变信号幅度来避免疼痛刺激。相应地,图3显示了本公开的治疗比标准的SCS治疗对于引线移动,患者位置,活动程度和活动类型的敏感度显著降低。
图4是柱状图,其示意了接受本公开治疗的患者的活动分值。该活动分值是生活质量分值,其表示患者能接受的活动量的总体满意程度。如图4所示,柱条401显示在开始治疗前分值1.9(例如,差或一般)的患者。该分值随着时间增加(柱条402-404),故在第二天治疗结束时,患者报告接近3(与“良好”相当)的分值。预计在更长的研究中,患者的分值可以比图4所示的更高。然而,即使是图4所示的结果也已显示出在三天周期内接受本公开的治疗的患者的活动分值有53%的改善(和基准对比)。有趣的是,患者还显示出他们在接受本公开的治疗时弊接受标准的SCS治疗时更有活力。据不完全统计,接受标准的SCS治疗的患者在相同的时间周期内仅能够体验到10-15%的改善。
图5A是柱状图,其示意了接受本公开的治疗的患者执行六项活动的活动分值,六项活动是:站,走,爬,坐,开车,和吃。对于每一项这些活动,柱条组(以参考编号501,502,503......506标记个别的组)显示这些患者的活动分值在过程期间总体上有改进。这些结果进一步显示活动的改善是广泛的而不是局限于特定的活动。更进一步地,这些结果在每一相活动中均显示了显著水平的改善,范围从从吃的30%到站,走和爬楼梯的80%-90%。顺便可提到的是,接受标准的SCS治疗的患者在患者的活动上预期只能体验到约10%-20%的改善。还顺便提及的是,在至少一些接受标准SCS治疗时为驼背,并不能直立的患者中直接观察到活动程度的改善。相形之下,在接受本公开的治疗时这些患者能够直立,并参加其它正常活动。
这些患者体验到的改善不局限于活动的改善,也延及相关的不活动性,包括睡眠。例如,当趴着时,接受标准的SCS治疗的患者会建立特定水平的信号输送参数。当该患者在睡眠时蜷曲时,该患者可能经受由标准的SCS治疗提供的疼痛减少上的明显变化,足以使该患者醒来。在许多情形下,在SCS信号想要减轻的疼痛之上,该患者可能额外经受由该SCS信号本身产生的疼痛。相形之下,采用本公开的技术则可避免此种不希望的作用。图5B和5C显示了接受本公开治疗的患者在睡眠上的平均效果。图5B显示了患者干扰的减少,图5C显示了睡眠小时数的增加。在其它实施方式中,该患者可能能够以降低的疼痛进行其它任务。例如,患者可以驾驶,而无需调节该植入装置提供的治疗水平。相应地,在这种情形和/或其它情形下,本公开的治疗可以更便于患者使用,其提高了这些患者的生活质量。
根据另外的患者反馈,在目标位置(例如,其接受本公开的治疗,引线没有与预定位置显著地偏移)接受了本公开治疗的测试患者中每一个都倾向于本公开的治疗,而非标准的SCS治疗。此外,不管患者接受到的疼痛解除水平,88%的患者都倾向于本公开的治疗,而非标准的SCS治疗,因其降低了他们的疼痛而不产生感觉异常。这显示尽管患者可能在感觉异常和疼痛中更倾向于感觉异常,对无感觉和同时疼痛和感觉异常之间绝大多数都倾向于无感觉。通过本公开的治疗获得的结果是通常所知的依靠感觉异常(即,掩盖)来解除疼痛的标准SCS治疗不可达到的。
更进一步地,不完全的数据显示接受本公开治疗的患者经历的肌肉锁止比用标准SCS要少。特别地,患者报告没有痉挛,抽筋,和肌肉疼痛,在接受标准SCS时他们经历过全部或者一些这类情况。患者还报告对于主观意志下的肌肉活动无干扰,而显示他们能不受本公开的治疗阻挠而进行运动活动。更进一步地,患者还报告对其它感觉无干扰,包括触觉(例如,察觉振动),温度和本体感觉。在多数情形下,患者报告对伤害性痛觉无干扰。然而,在有些情形下,患者报告了无切口疼痛(与用于植入该信号输送引线的切口有关)或无慢性外周疼痛(与关节炎有关)。相应地,在特定的实施方式中,本公开的技术的各个方面可被用于解除伤害性疼痛,包括急性外周疼痛,和/或慢性外周疼痛。例如,至少在一些情形下,具有低至中等伤害性疼痛的患者在上述治疗后有解除。具有更严重/慢性的伤害性疼痛的患者通常不能充分响应本治疗技术。此结果可以被用于判别该患者所经受的疼痛类型的诊断中,其将在下文作更详细的论述。
图6A为柱状图,其表示成功的治疗结果数目作为本公开的治疗提供的引线上的活性接触的位置(由椎骨位置表示)的函数。在一些情形下,在超过一个椎骨位置提供调节时,患者获得成功结果。如图6A所示,在椎体T9至T12的大轴向范围上(以沿着脊柱的上下方向计量)获得了成功结果。这是出人意料的结果,因为其显示出,尽管可能有优选的目标位置(例如,T10附近),该引线也可以被设置在宽范围的位置上,而仍然产生成功的结果。特别地,相邻的椎体通常彼此隔开约32毫米(取决于特定患者的解剖学条件),因此在四个椎体(约128毫米)的宽范围和一至二个椎体(约32-64毫米)的窄范围上获得了成功的结果。相形之下,标准的SCS数据通常显示在引线位置移动仅1毫米的情形下该治疗就可能由有效变为无效。在下文中将详细论述,与本公开的治疗有关的适应性和通用性可以对患者和专业人员均产生明显的益处。
图6B和6C是流程图,其示意了根据本公开的特定实施方式的治疗患者的方法。厂商或其它适合的组织可以提供说明书给专业人员,用于执行这些及其它此处公开的方法。厂商还可以对所公开的***进行编程,以实现至少一些这类方法。图6B显示了方法600,其包括将信号发生器植入患者体内(框610)。该信号发生器可以被植入于患者的下背或其它适合的位置。该方法600进一步包括,将信号输送装置(例如,引线,叶片或其它适合的装置)植入于该患者的脊髓区域(框620)。该方法的此部分可以依次包括,将该装置(例如,该装置的活动接触)植入于约T9至约T12的椎骨水平(例如,约T9-T12,包含临界值)(框621),以及于该脊髓中线至该DREZ的横向位置,包括临界值(框622)。在框630,该方法包括,通过该信号发生器和该信号输送装置施加一高频率波形。在特定的实施例中,该信号(或至少一部分该信号)的频率可以为约1.5kHz至约100kHz,或约1.5kHz至约50kHz,或约3kHz至约20kHz,或约3kHz至约15kHz,或约5kHz至约15kHz,或约3kHz至约10kHz。该方法600进一步包括阻滞,镇压,抑制或者其它方式减少患者的疼痛,例如,慢性下腰痛(框640)。该方法的此部分可以依次包括,减少疼痛而无不需要的感觉效果和/或限制(框641),和/或无运动效果(框642)。例如,框641可以包括,减少或消除疼痛,而不减少患者其它感觉的知觉,和/或不引起另外的疼痛。框642可以包括,减少或消除疼痛,而不因袭肌肉活动和/或不干涉运动信号传送。
图6C显示了方法601,其包括除如上所述参照图6B之外的特征。例如,施加高频率波形的过程(框630)可以包括在大幅度范围(例如,在一个实施方式中为小于1mA直至约8mA,以及在其它实施方式中分别为小于1mA直至约6mA和约5mA),而不产生不需要的副作用,如不希望的感觉和/或运动干扰(框631)。在另一个实施方式中,施加高频率波形的过程可以包括以固定幅度施加该波形(框632)。如下文进一步所述,这些方面中每一个方面均可给患者和/或专业人员提供便利。
阻滞,镇压或者其它方式减少患者疼痛的过程(框640)可以包括这样做而不产生感觉异常(框643),或与故意产生感觉异常(框644)相联系。如上所述,临床results显示多数患者倾向于无感觉异常,而不倾向于存在感觉异常,例如,因为在该患者变化位置和/或调节信号幅度时,该感觉异常的感觉可能转换为不舒服的或疼痛的感觉。然而,在有些情形下,患者可能倾向于感觉异常的感觉(例如,先前接受过SCS的患者),因此可以有接受它的选项。包括感觉异常引发的调节和非感觉异常引发的调节的组合的更多方法细节被包括于美国临时申请号61/171,790中,其先前以参考方式被合并于此。在其它情形下,感觉异常可以被专业人员用于位点选择(例如,确定作用电极被设置的位置)。除上述之外,减少患者疼痛可以包括这样做而对标准SCS通常高灵敏度的患者特征相对不敏感(框645)。这些特征可以包括患者移动(框646)和/或患者位置(框647)。
2.2.进一步研究
Nevro公司,本申请的受让人,已经进行了进一步研究,以评估如上所述的治疗的特定参数和结果。在进一步研究中,患者接受植入的引线和刺激器(simulators),并在若干月期间接受治疗。此研究没有包括和常规的SCS技术对于每一患者的直接比较,尽管一些患者在接受根据本技术的调节之前接受了常规的SCS治疗。选择的结果被描述于下。
图7A是该后续研究期间典型的引线放置示意图。在此研究中,两根引线111(显示为第一引线111a和第二引线111b)被总体上端对端设置,以提供沿该患者的脊柱的若干椎骨水平延伸的调节能力。该引线111a,111b被设置为轻微地重叠,以适应引线位置的可能移动。在该治疗期间,该两根引线111a,111b的接触C每次在一根引线上被激活。换言之,任一时刻只有一根引线111的接触C是活化的,并且信号不是在位于不同的引线111上的接触C之间被引导。尽管在该临床研究期间使用两根引线,预计在普遍应用中可以在适当的椎骨水平设置单一的引线。该引线可以具有更宽泛间隔的接触,以实现此处所述的相同或类似效果,如下将参照图9描述更多细节。
每一引线111a,111b的接触C都具有约3毫米的宽度W2,并彼此隔开约1毫米的距离D1。相应地,相邻接触C之间的中心至中心间距S为约4毫米。引线111a,111b被设置在该患者的脊髓中线189处或附近。通常一根引线被设置在该中线189的一侧,而另一根引线被设置在该患者的中线189的另一侧。在该研究期间,观察到若干显著的作用。例如,该引线111a,111b可以被设置在相对较宽的总宽度为离开该中线189以+3-5毫米的窗口(例如,总宽度为6-10毫米)的各个位置,而不显著影响治疗功效。此外,患双边疼痛(例如,该中线189的双侧)的患者报告了双边解除,和该引线110a,110b的横向位置无关。例如,在该中线189的一侧有引线位于窗口W1内的患者报告了该中线189的相对侧上的疼痛解除。这和常规的SCS治疗不同,其实现完全的双边接触大体上对于偏离严格的中线位置非常敏感。进一步地,相邻的活化接触之间的距离显著大于典型的用于标准SCS的距离。专业人员能够“跳过”(例如,停用)若干个连贯的接触,以使得相邻的活化接触具有,例如,20毫米的中心至中心间距,以及例如,17毫米的边至边间距。此外,患者对于该活化接触的轴向定位不敏感。例如,专业人员能够在很宽的接触间距范围内形成相同的或者总体上相同水平的疼痛解除,该接触间距预期可延伸至多达两个椎体(例如,约64毫米)。更进一步地,在给予的接触确定为阴极或阳极时,专业人员获得了类似的治疗作用,其在与此申请同时递交的未决的美国申请12/___________(代理文件号66245.8024 US)中以更详细的细节进行了描述,其以参考方式被合并于此。
对于该后续研究中的多数患者,这些引线被植入于T9-T10椎骨位置。这些患者在接受该治疗之前通常主要经受下腰痛,尽管有一些也经受腿疼。根据在该后续研究和该初步研究期间获得的结果,预期可解除下腰痛的总体椎骨位置为约T9至约T12。进一步的预期是在此范围中,在T12或T11-T12的调节可以更有效地治疗患有下腰痛和腿疼的患者。然而,在有些情形下,患者在较高的椎骨位置(例如,T9-T10)体验到较高的腿疼痛解除,并且在进一步的特定情形下,在T9的调节比在T10的调节产生更多的腿疼痛解除。相应地,在如上所述的总体范围内,特定的患者可能具有产生相应的优选椎骨位置的生理特性或其它因素。
在该后续研究中接受治疗的患者在约10kHz的频率接受方波信号。患者在100%作业周期接受调节,初始电流幅度(两相)为约2mA。患者和专业人员能够调节该信号幅度,通常为多达5mA。在任何上述水平,这些信号脉冲预计在阈上,意味着它们可以独立于任何目标神经群体的内在神经活动,在目标神经群中触发动作电位。
在该调节***100被植入和激活后,对后续研究中的患者定期进行评估。接受治疗的30天后这些患者的VAS分值报告平均为约1.0,其表示以上参照图2所述的趋势延续了一段时间。至少一些患者报告了VAS分值增加至多达约2.25的水平。预计这种增加是由患者的活动程度增加所致。相应地,不认为此种增加表示治疗功效的降低,反而显示了有效的治疗容许患者参加他们本不会参加的活动。
图7B显示了参加各种活动并接受根据该后续研究方案的调节的患者的综合Oswestry分值。100的分值对应彻底无能条件,0分值对应无失能。这些分值显示了随着时间的总体改善,例如,符合或者事实上相对于初步研究的结果有改善。此外,若干患者报告了在接受根据上述实施方式的治疗后不再需要或使用拐杖或轮椅。
来自后续研究的结果证实了该治疗的疗效对于当前幅度改变的相对不敏感性。特别地,患者通常接受约2.0mA至约3.5mA水平的调节。在多数情形下,当患者改变所施加信号的幅度时,他们没有报告疼痛减少上的显著变化。在报告不希望的副作用之前,患者在若干情形下能够增加当前幅度直到约5mA的水平。此外,该副作用是逐渐开始发生,而非突然方式。来自一些患者的不完全反馈显示,在高幅度(例如,5mA以上),治疗功效开始下降,和任何不希望的副作用的发生无关。进一步预期是患者可以在小于2mA的当前幅度接受有效的治疗。此期望至少部分地基于表示作业周期的减少(例如,减少至70%)没有减少功效的数据。
该后续研究的结果还显示,多数患者(例如,约80%的患者)在该***被植入和激活后体验到至少满意的疼痛减少,而不改变该信号输送参数的任何方面(例如,活化接触的数量和/或位置,和/或当前的幅度)。这些患者的小子集(例如,约20%)在参加特定活动时受益于被增加的当前幅度,和/或在睡眠时受益于较低的当前幅度。对于这些患者,在参加活动时增加信号幅度产生较高程度的疼痛解除,在晚上减少该幅度降低了过度刺激的可能性,同时也节约能量。在代表性的例子中,患者在两种程序之间选择:在相对高的当前幅度(例如,约1mA至约6mA)提供信号的“强”程序,和在较低当前幅度(例如,约0.1mA至约3mA)提供信号的“弱”程序。
另一个在该后续研究期间被观察到的作用是患者自愿降低了他们摄入阿片类和/或其它疼痛药物,他们曾经在接受根据本技术的调节之前接受这些药物以解除疼痛。该患者的自愿药品摄入减少预计为对该药物的需要降低的直接后果,其也是根据本技术的调节所提供的直接后果。然而,由于阿片类物质的上瘾特性,患者自愿放弃使用阿片类物质的轻易程度令人意外。因此,也可预期对于至少一些患者,本技术除减少疼痛之外,也有作用可减少对这些药物的化学品依赖。相应地,可预期在至少一些实施方式中,根据本公开的治疗技术可被用于减少或消除患者的化学品依赖,其与患者是否具有下腰痛和/或由于下腰痛被治疗无关。
进入该后续研究的患者通常体验过神经性疼痛,伤害性疼痛,或神经性疼痛和伤害性疼痛的组合。神经性疼痛总体上指神经机制功能障碍导致的疼痛,对于报告疼痛,其可以产生痛觉而无外部神经触发。伤害性疼痛总体上指患者本身感觉的疼痛,其由特定的机械或其它物理作用触发(例如,椎间盘突出,肌肉损伤,或骨损伤)。总的来说,神经性的疼痛是一致的,伤害性的疼痛是波动的,例如,随患者位置或活动波动。在至少一些实施方式中,根据本技术的治疗对于解除神经性的疼痛比解除伤害性的疼痛显得更有效。例如,在进入治疗之前报告低水平疼痛波动的患者(指示主要神经性疼痛),在治疗期间比疼痛起伏显著的患者得到更高的疼痛解除。在两种特定情形下,该治疗没有证明有效,并可以认为这是由患者背部解剖学的机械问题导致的,其确定该患者比现在的治疗而言更适合接受外科手术。相应地,除解除神经性的疼痛和(至少在一些情形下)伤害性疼痛之外,根据本公开的技术也可以作为筛选工具来鉴别主要遭受伤害性疼痛而非神经性疼痛的患者。例如,该专业人员可以至少部分地基于患者在接收根据本技术的信号时疼痛减少中疼痛的存在和/或量(包括波动量)来进行这种鉴别。采用此诊断技术,这些患者可以被引导至外科手术或其它可以直接解除该伤害性疼痛的手术。特别地,患者可以接受根据本技术的信号和,如果这些患者无反应,则可能适合外科手术。当然,如果该患者有反应,他们可以继续接受根据本技术的信号作为治疗。
3.0 作用机制
图8是示意图(根据Linderoth和Foreman,“脊髓刺激在疼痛综合症中的机制:动物模型的功用”,Pain Medicine,卷51,2006),其示意了预期的标准SCS治疗的作用机理,以及根据本技术的实施方式提供的治疗的可能作用机制。当周围神经受伤时,可以认为δ和C损伤感受器提供增加水平的兴奋性递质至脊髓背角的二级神经元。标准的SCS治疗由箭头701表示,预计其具有两种效果。一种作用是沿着该脊柱传送至该患者的大脑并被察觉为感觉异常的顺向作用。另一种是刺激内神经元池的逆向作用,其随后抑制对二级神经元的传入。
本公开的治疗的一个可能作用机理由箭头710表示,其包括在后根水平产生不完全的传导阻滞(例如,传入和/或传出信号传送的不完全阻滞)。此种组织可以发生在脊柱,背角,和/或后根入口区,除后根之外,或者作为替代。在任何情形下,该传导阻滞对于较小的δ和/或C纤维都是选择性的和/或优先作用于其上,并且预期可导致对二级神经元的兴奋输入减少,因此使沿着脊髓丘脑途径供给的疼痛信号减少。
另一个可能的作用机理(由图8中的箭头720表示)包括更深地刺激内神经元池并由此增加对该二级神经元的传入抑制。这可以有效地降低该二级神经元的灵敏度,并在该慢性疼痛相关的信号影响到该患者之前将它们转换为接近正常状态。
另一个可能的作用机理涉及遭受慢性疼痛的病人体内的神经元的敏感性。和不经受慢性疼痛的人体内的相同神经元对比,可以认为在这种患者体内的疼痛传送神经元可能为不同的过敏感状态,其导致“一触即发”的高度致敏细胞,并且在较低阈值的刺激下比不经受慢性疼痛的人的细胞更频繁地以不同形式发作。因此大脑以被显著改变的传送方式收到显著增加的大量的作用电位。相应地,本公开治疗所依据操作的可能作用机理是通过将慢性疼痛患者体内的该神经细胞向正常基线复原或移动来减少这种超敏性以及非慢性疼痛患者的发作频率。此作用即可以在此患者群体中减少痛觉,而不影响其它神经传递(例如,触觉,热觉,等等)。
上述作用机制在此被确定为可能的作用机制,其可能是上述临床结果的原因。特别地,这些作用机制可以解释小的缓慢Aδ和C纤维传送的疼痛信号可以被抑制,而沿着较大较快的Aβ纤维的信号传送不受影响的意外结果。这和通过标准SCS治疗获得的典型结果相反,在标准的SCS治疗期间,调节信号基本上以低幅度影响Aβ纤维,但不影响Aδ和C纤维,直至该信号幅度高至产生疼痛或其它由Aβ纤维传送的不需要的效果。然而本公开的各个方面不必直接受束缚于这种机制。另外,前述的两种可能机制可能同为一些实施方式中所观察到结果的原因,并且在其它实施方式中,其它机制也可能是所观察到结果的原因,既可以是单独的,也可以是何前述两种机制的任何一个的联合。一个这种机制包括增加的高频调节穿透围绕脊髓的脑脊液(CSF)的能力(和标准SCS刺激对比)。另一个这种机制是与标准的SCS频率相比,该患者的组织对高频率在阻抗上的预期减少。又一个这种机制是高频信号引起非同步神经响应的能力,如2009年1月29日申请的未决美国申请号12/362,244中的更详细描述,其以参考方式被合并于此。尽管与本公开的技术有关的更高频率初始可能比常规的SCS技术看起来需要更多能量,和常规的SCS值相比,信号幅度可以被降低(由于信号穿透增加)和/或该作业周期可以被减小(由于后述的暂留效果)。相应地,与标准的SCS技术相比较,此公开的技术可以导致净能量的节省。
4.0 与某些实施方式有关的预期优点
和标准的SCS治疗相比,某些上述实施方式可以为患者和/或专业人员提供一个或多个各种优点。一些这类优点如上所述。例如,该患者可以接受有效的疼痛解除,而没有患者觉察的沿着脊髓的正常感觉和运动信号的破坏。在特定实施方式中,尽管该治疗可能对正常的运动和/或感觉信号产生一些影响,该影响也低于患者可以确实地在体内感觉到的水平,例如,无需通过仪器或其它装置的外部援助。相应地,患者的运动发信号及其它感觉发信号水平(非与目标疼痛有关的发信号)可以被保持在治疗前的水平。例如,如上所述,该患者可以体验到明显的疼痛减少,其很大程度上和该患者的移动和位置无关。特别地,该患者可以采取各种位置和/或接受各种与日常生活和/或其它活动有关的活动,无需调整治疗被施加于该患者所依据的参数(例如信号幅度)。此种结果可以大为简化该患者的生活,并减少患者在参加各种活动时为经受疼痛解除所需的努力。此结果还可以为在睡眠期间经受疼痛的患者提供改善的生活方式,如上参照图5B和5C所述。
甚至对于从信号幅度变化中收到治疗益处的患者,上述治疗也可以提供优点。例如,这种患者可以从有限数量的程序(例如,两或三种)中挑选,每种程序具有不同的幅度和/或其它信号输送参数,以解决一些或所有该患者的疼痛。在一个这种例子中,该患者在睡眠以前激活一个程序,并在醒来后激活另一个。在另一个这种例子中,该患者在睡眠以前激活一个程序,在醒后激活第二程序,并在参加特定的会引起疼痛的活动以前激活第三程序。此种患者选项的缩减集合可以大为简化该患者便于管理疼痛,而不减少(事实上是增加)该治疗有效地解除疼痛所需条件的能力。在任何包括多个程序的实施方式中,该患者的工作量可以通过自动探测患者环境的变化,并自动确定和输送适当的治疗方式而被进一步减少。这种技术和相关的***的补充细节被公开于共同未决的美国申请号12/703,683,其在先前以参考方式被合并于此。
在如上所述的该临床研究期间观察到的另一个优点是,在该患者未感受到治疗水平的变化时,其为渐变。这和常规的SCS治疗有关的典型的变化不同。采用常规的SCS治疗,如果患者变化位置和/或变化幅度设置,该患者会感受倒突然发作的疼痛,通常被患者描述为无法忍受。相形之下,如上所述的临床研究中的患者在用本公开的治疗方法治疗时,在信号幅度被增加超过阈值水平,和/或当该患者变化位置时报告了逐渐发生的疼痛,该疼痛被描述为逐步变得不舒服。一个患者描述感觉与发生抽筋类似,但从未完全发展。此种病人对信号输送参数的响应上的显著差异可以使该患者在期望时更自由地变化信号输送参数和/或姿势,无需害怕产生即刻的疼痛作用。
来自如上所述的该临床研究的另一个观察结果是,在发生有效治疗和发生疼痛或不适之间的幅度“窗口”相对较宽,并且特别是比标准的SCS治疗宽。例如,在标准SCS治疗期间,该患者通常体验到特定幅度的疼痛减少,并且开始感受到约1.2至约1.6倍该幅度的来自该治疗信号的疼痛(其可能是突发,如上所述)。这和约1.4的平均动态范围对应。另外,接受标准SCS刺激的患者通常希望接受疼痛发作水平的刺激,因为该治疗常常在该水平最有效。相应地,患者的偏好可能进一步减少该有效动态范围。相形之下,根据本公开的技术的治疗使患者获得1mA或更低的疼痛解除,而不遭遇疼痛或肌肉锁止,直至施加的信号幅度为4mA,并且在有些情况下为多达约5mA,6mA,或8mA,这和大得多的动态范围有关(例如,在一些实施方式中为大于1.6或60,或在其它实施方式中为大于100%)。即使在前述的幅度水平,该患者经受的疼痛也显著地少于标准SCS疼痛发作相关的疼痛。此结果的预期优点是患者和专业人员用本公开的方法可以比采用标准的SCS方法具有明显更宽的范围来选择适当的治疗幅度。例如,该专业人员可以增加信号幅度,来影响更多(例如,更深)的位于脊髓的纤维,而不一引发不需要的副作用。较宽幅度窗口的存在可能还有助于本公开的治疗对于患者姿势和/或活动的相对不敏感性。例如,如果在被植入的引线和目标神经群之间的相对位置在患者移动时变化,该信号的有效强度在其到达目标神经群体时也可能变化。当该目标神经群对较宽范围的信号强度不敏感时,此作用即可以容许更大的运动范围,而不引起不希望的副作用。
尽管本公开的治疗可以容许专业人员在较宽范围的幅度上提供调节,在至少一些情形下,该专业人员可以不需要使用整个范围。例如,如上所述,与标准的SCS治疗相比,患者可能需要在其中调节治疗的情形可以被显著减少,因为本公开的治疗对患者位置,姿势和活动程度相对不敏感。。除上述作用之外,或者替代地,根据本公开技术施加的信号的幅度可以比标准SCS相关的幅度更低,因为本公开技术可以靶定离脊髓表面更接近的目标神经元。例如,可以认为与下腰痛有关的神经纤维在T9和T12(包括临界值)之间浸入脊髓,并因此在这些椎骨位置靠近该脊髓表面。相应地,该治疗信号的强度(例如,当前幅度)可以适度,因为该信号不必穿透脊髓组织的显著深度来获得预期效果。这种较低幅度的信号可以有引起副作用的降低(或零)趋势,如不需要的感觉和/或运动响应。这种低幅度信号还可以降低该被植入的脉冲发生器需要的能量,并可以因此延长电池寿命,以及在充电和/或替换该电池之间的相关时间。
根据上述参数的治疗又一个预期的优点是,专业人员不必用标准的SCS引线放置通常所需的精确性的相同水平植入该引线。例如,尽管上述结果是对于具有两根引线(一根设置在该脊髓中线的任一侧)确定的,可以预期,仅用单一的引线放置在该中线,患者也将受到相同的或大体上类似的疼痛解除。相应地,专业人员可能只需要植入一根引线而非两根。更进一步的预期是,在该引线被设置为以相反方向偏离该脊髓中线时,该患者可以在躯体的另一侧接受疼痛解除。因此,即使该患者具有双边疼痛,例如,一侧比另一侧更痛,该患者的疼痛可以用单一的被植入的引线解除。更进一步地,可以预期引线位置可以水平地从解剖学和/或生理学脊髓中线至远离该脊髓中线3-5毫米的位置(例如,在后根入口区或DREZ之外)。上述该中线的标识可以不同,但是期望是上述范围对解剖学和生理学的中线标识均有效,例如,作为本治疗的鲁棒(robust)特性结果。更进一步地,在一个实施方式中,可以预期该引线(或更特别地,该引线上的活化接触或接触)可以被设置在约T9-T12范围中任何各种轴向位置,以及在另一个实施方式中为T9-T12范围中的一至两个椎体,而仍然提供有效治疗。相应地,该专业人员的选择的植入位点不必如同标准的SCS步骤那样(轴向和/或水平地)被精确地确定或定位,而仍然产生明显的患者益处。特别地,该专业人员可以将该活化接触位于上述范围内,而不调节接触位置,来增加治疗功效和/或患者的舒适度。另外,在特定的实施方式中,在上述位置的接触可以是向该患者输送治疗的唯一的活化接触。上述特征,可以单独或组合式地减少所需的植入该引线的时间,并可以在植入引线时给予专业人员更大的灵活性。例如,如果该患者在优选的植入位点具有瘢痕组织或另外的障碍物,该专业人员可以将该引线定位在别处,且仍然获得有益的结果。
可以由上述观察到对引线放置和信号幅度的不敏感性的又一个预期的优点是,当引线被植入的时候进行测绘步骤的需求可以被显著降低或消除。这是对于患者和专业人员两者的便利,因为它降低了建立有效的治疗方式所需的时间和尝试。特别地,标准的SCS治疗通常需要专业人员调整引线的位置和该引线输送的信号幅度,而该患者在操作室报告是否实现了疼痛的减少。因为本公开的技术对于引线位置和幅度相对不敏感,该测绘过程可以被完全取缔。相反,该专业人员可以将该引线放置在选定的椎骨位置(例如,约T9-T12),并以预定幅度(例如,1至2mA)施加信号,试错法优化过程(对于接触的选择和/或幅度选择)被显著减少或取缔,并随即解放该患者。除上述作用之外,或者替代地,在至少一些实施方式中,该专业人员可以用简单的双极电极排列向该患者提供有效的治疗,与用于现有***中引导或指引治疗信号的三极或其它更复杂的布置相对。鉴于上述(多种)作用,在特定实施方式中,可以预期完成患者引线植入步骤和选择信号输送参数所需的时间可以被两种或两种以上因素减少。因此,专业人员可以每天治疗更多患者,并且患者可以更迅速地无痛参加活动。
上述(多种)作用不仅可以延及在专业人员的设备处进行的测绘步骤,也可以延及随后的试验期间。特别地,接受标准SCS治疗的患者通常在接受引线植入后花费一周的时间,在期间调整施加于引线的幅度,以求为各种患者位置和患者活动建立适合的幅度。因为本公开的治疗的实施方式对患者位置和活动程度相对不敏感,对此试错法周期的需要即可被降低或取缔。
与本公开的治疗的实施方式有关的又一个预期的优点是该治疗可以较为不受患者的习惯影响。特别地,在至少一些情形下可以预期,施加于该患者的高频信号可以产生非同步的神经响应,如先前以参考方式合并于此的共同未决的美国申请号12/362,244所述。该非同步响应可以比同步响应更不可能产生习惯,该同步响应可以由较低频率调节产生。
上述治疗的实施方式的又一个特征是,可以不判别阳极接触和阴极接触而应用该治疗。如美国申请号_______(代理案号66245.8024.US,先前以参考方式合并于此)中更具体的内容所述,此特征可以简化为该患者制定治疗方式的过程。另外,由于该波形的高频率,邻近组织可能以伪稳态信号认知该波形。由于上述作用之一或者它们两者的结果,邻近两个电极的组织均可有利地被影响。这和标准SCS波形不同,对于标准SCS波形,一个电极一贯为阴极,而另一个一贯为阳极。
在任何上述实施方式中,被提供至患者的治疗的各个方面可以在如上所述的临床试验期间使用的参数之内或之外变化,而仍然使遭受慢性下腰痛的患者获得有益的结果。例如,该引线主体(特别是引线主体电极或接触)的位置可以在如上所述的明显的横向和/或轴向范围上变化。所施加的信号的其它特性也可以变化。例如,如上所述,该信号可以在约1.5kHz至约100kHz的频率被输送,并在特定实施方式中为约1.5kHz至约50kHz。在更多特定实施方式中,该信号可以约3kHz至约20kHz的频率被提供,或约5kHz至约15kHz,或约3kHz至约10kHz。在特定实施方式中该信号的幅度可以为约0.1mA至约20mA,而在其它特定实施方式中,可以为约0.5mA至约10mA,或约0.5mA至约4mA,或约0.5mA至约2.5mA。所施加信号的幅度可以上调和/或下调。在特定实施方式中,该幅度可以被增加或设定在初始水平,以形成治疗作用,然后减少至较低水平,以节省能量而又不放弃功效,其被公开于2008年11月4日申请的未决的美国申请号12/264,536中,并以参考方式被合并于此。在特定实施方式中,该信号幅度指电流水平,例如,对于电流控制***。在其它实施方式中,该信号幅度可以指电压电平,例如,对于电压控制***。该脉冲宽度(例如,对于仅阴极相位的脉冲)可以在约10微秒至约333微秒之间变化。在进一步的特定实施方式中,该脉冲宽度可以为约25微秒至约166微秒,或约33微秒至约100微秒,或约50微秒至约166微秒。这些为上述参数选择的特定值可以在患者之间和/或指征之间和/或基于被选取的椎骨位置变化。另外,除如上所述的参数之外,或者替代地,该方法可以利用其它参数,来监视和/或控制患者治疗。例如,在脉冲发生器包括恒压布置而非恒流布置的情形下,可以用相应的电压值代替如上所述的电流值。
在至少一些实施方式中,可以预期上述幅度将是超阈值的。还可以预期的是,在至少一些实施方式中,对上述信号的神经响应将如上所述是非同步的。相应地,该信号的频率可以被选择为比该患者的脊髓处的目标神经元的不应期更高(例如,两倍至十倍),其至少在一些实施方式中预期可产生非同步的响应。
根据此公开的更进一步的实施方式,患者可以接受多个信号。例如,患者可以接受两个或两个以上信号,每个信号均具有不同的信号输送参数。在一个特定的例子中,这些信号互相交错。例如,该患者可以接受和10kHz脉冲交错的5kHz脉冲。在其它实施方式中,患者可以在接受不同频率的连续脉冲“包”,每一个包具有小于一秒,若干秒,若干分钟,或更长时间的持续时间,其取决于特定患者和指征。
在更进一步的实施方式中,作业周期可以在如上所述的50%-100%范围内变化,开启/关闭周期的长度也可以在此范围变化。例如,已经观察到患者可以有治疗作用(例如,在调节已经停止后疼痛的减少持续明显的周期)。在特定例子中,这些有益的作用有时可以持续10-20分钟,并且在更进一步情形下其它情形多达一小时以及多达一天或更多。相应地,可以编程该模拟器以停止调节多达一小时的数个周期,并考虑适当的余量作为重新引发该有益作用所需时间。和高工作循环的***相比,以及和具有较短开启/关闭周期的***相比,此布置可以显著地减少***能量消耗。
5.0 代表性的引线结构
图9是根据此公开的实施方式的引线910的部分示意图,该引线910具有第一和第二接触C1,C2,它们被设置为输送调节信号。这些接触相应地被设置为在被植入时接触患者的组织。该引线910可以包括至少两个第一接触C1和至少两个第二接触C2,以通过每一个接触组合支持双极调节信号。在此实施方式的一个方面,引线910可以沿着主轴或引线轴A为细长的,并且该接触C1,C2与该主轴A等距间隔。总体上,术语细长指引线或其它信号输送部件的长度(例如,沿着脊髓的长度)大于其宽度。该引线910可以具有全长L(在其上设置活性接触),其比典型的引线长。特别地,该长度L足以在一个或多个椎骨位置(包括相关的神经群)处设置第一接触C1,并在另外的椎骨位置(包括相关的神经群)处设置第二接触C2,其和该第一接触隔开并在其上。例如,该第一接触C1可以被设置在椎骨T9-T12,以治疗下腰痛,该第二接触C2可以被设置在椎骨上位置(例如,颈部位置),以治疗臂疼痛。代表性的引线长度为约30厘米至约150厘米,在特定实施方式中为约40厘米至约50厘米。可以施加脉冲于根据若干不同布置的两个接触组。例如,提供给一个组的脉冲可以和被施加于另一个组的脉冲交错,或者同一信号可以被迅速地从一个组切换至另一个组。在其它实施方式中,这些被施加于个别的接触,接触对,和/或不同组中的接触的信号可以其它方式被复合。在任何这些实施方式中,每一个接触C1,C2都可以具有适当选择的表面面积,例如为约3平方毫米至约25平方毫米,并且在特定实施方式中,为约8平方毫米至约15平方毫米。在给定引线上的个别的接触可以在上述范围内具有不同的表面面积,其与该引线上的相邻的或其它接触不同,其取值依赖于特征,包括该个别接触的椎骨位置。
图9所示的引线910的实施方式的另一方面是,该第一接触C1的间距可以比通常与标准SCS接触有关的间距更宽。例如,该第一接触C1可以隔开(例如,最近的边至最近的边)第一距离S1,其比相应的在直接相邻的第二接触C2之间的第二距离S2宽。在代表性的实施方式中,该第一距离S1可以为约3毫米直至和二分之一椎体,一个椎体,或两个椎体长度对应的距离(例如,分别地为约16毫米,32毫米,或64毫米)。在另一特定实施方式中,该第一距离S1可以为约5毫米至约15毫米。此种被增加的间距可以减少引线910的复杂程度,并仍然可以向该患者提供有效的治疗,因为如上所述,本公开的治疗的效力对于该信号输送接触的轴向位置相对不敏感。当被用于施加根据本公开的方法的高频调节时,该第二接触C2可以具有类似的宽间距。然而,在另外的实施方式中,引线910的不同部分可以具有以不同距离被间隔开的接触。例如,如果该患者通过该第一接触C1在第一椎骨位置接受高频率疼痛抑制治疗,该患者可以任选地在第二椎骨位置通过隔开间距S2的该第二接触C2接受低频(例如,1500Hz或更低,或1200Hz或更低)的感觉异常感应信号。距离S2可以小于距离S1,并且在特定实施方式中,可以采用标准SCS治疗的接触间距的典型数值(例如,4毫米间距),因这些接触可以被用于提供这种治疗。
相应地,该第一接触C1可以根据和第二接触C2不同的信号输送参数输送调节。在更进一步的实施方式中,该下方的第一接触C1可以具有紧密间距S2,并且该上方的第二接触C2可以具有宽间距S1,这取决于患者的指征和/或偏好。在更进一步的实施方式中,如上所述,在该下方和上方位置处的接触均可具有宽间距,例如,为了在沿着脊髓的多个位置支持高频调节。在其它实施方式中,该引线910可以包括不同接触间距的其它布置,这取决于特定患者和指征。例如,该第二接触C2(和/或该第一接触C1)的宽度可以是相邻接触之间的间距的较大部分,其比图9所示的更大。相邻的第一接触C1之间的距离S1可以小于完整的椎体长度(例如,5毫米或16毫米)或大于一个椎体长度,而仍然实现与间距增加有关的优点,例如,降低复杂程度。该引线910的接触可以全部等距间隔(例如,间隔多达约两个椎体),或这些接触可以具有如上所述的不同的间距。两个或两个以上第一接触C1可以在一个椎骨水平(例如,T9)施加调节,而两个或两个以上另外的第一接触C1可以相同或不同频率在不同的椎骨水平(例如,T10)提供调节。
在一些情形下,可能希望调节下方的接触C1和上方的接触C2之间的距离。例如,引线910可以具有线圈布置(像电话绳)或其它长度调节特征,其容许专业人员选择性地变化接触组之间的距离。在此布置的特定方面,该引线的卷绕部分可以位于该第一接触C1和第二接触C2之间。例如,在图10A所示的一个实施方式中,该引线910可以包括携带第一接触C1的近侧部分910a,携带第二接触C2的远侧部分910c,和具有预成型的可变长度的拉紧释放特征的中间部分910b,例如,波浪形或螺旋形特征。该引线910还包括探针通道或腔915,其延伸从该近侧部分910a通过引线910至该远侧部910c。
接着参照图10B,该专业人员将探针916***探针腔915,其矫直用于植入的该引线91。然后该专业人员将该引线910通过该探针916***患者体内,直到远侧部910c和相关的第二接触C2位于需要的位置。然后该专业人员用远侧引线装置917c将该远侧部910c相对于该患者固定。该远侧引线装置917c可以包括任何适合的用于固定该引线的遥控式可展开结构,包括但不限于可膨胀气球。
接着参照图10C,该专业人员可以部分或完全去除该探针916,并使该引线910的特性(例如,该中间部分910b采取其初始形状的自然趋势)为将该近侧部分910a拉向该远侧部分c。当该近侧部分910a具有相对于该远侧部分910c的期望的间距时,该专业人员可以用近侧引线装置917a(例如,缝合或其它引线锚)相对于该患者固定该近侧部分910a。在此中方式中,该专业人员可以选择在该近侧部分910a处的该第一接触C1和在远侧部分910c处的该第二接触C2之间的适当间距,其在沿着脊柱的多个患者位置提供有效的治疗。
图11A是引线910的近侧部分910a的放大图,其示意了根据此公开的特定实施方式的内部布置。图11B是基本上沿着图11A的11B-11B所取的截面图。现参照图11B,该引线910可以包括布置于外部绝缘部件918内,例如,塑料套筒内的多个导体921。在特定的实施方式中,该导体921可以包括中间导体921a。在另外的实施方式中,可以取缔该中间导体921a或用如上所述的探针腔915代替。在任何这些实施方式中,每一个个别的导体921可以包括多根导线919(例如,多丝状布置),其被个别的导线绝缘部件920围绕。在制造期间,该外部绝缘体918的选定部分和该个别的导线绝缘部件920可以被去除,由此沿着该引线910的长度将个别的导体921暴露于选定位置。这些暴露部分可以自行作为接触用途,并可以相应地向该患者提供调节。在另一实施方式中,环(或圆筒)接触被连接至该暴露部分,例如,通过束缚或焊接。制造者可以通过以特定方式间隔该外部绝缘部件918的被去除部分和该导线绝缘部件920来自定义该引线910。例如,制造者可以使用模板或其它布置来引导该去除过程,其包括但不限于烧蚀过程。此种布置容许该引线910的相同的总体结构可用于各种应用和患者,而无需重大变化。在此实施方式中另一方面,每一个导体921均可平行于另一个导体沿着该引线910的主轴在该外部绝缘体918内延伸,其与交织或盘绕布置不同。另外,个别的导体元件920的每一根导体线可以平行于其相邻导体线延伸,其也没有螺旋。预期单独的或组合的这些特征将增加该总体引线910的灵活性,其允许它以更高水平的通用性***和/或用于比常规引线更宽泛的患者解剖学条件。
图11C是图11A所示的近侧部分910a的部分示意放大图。如上参照图11B所述的该多丝状索的优点是,和常规的线圈导体相比,每一个导体921的阻抗可以被降低。因此,导体921的直径可以减少,而该引线910的总直径也可以被减少。有利地减少该引线直径的一个结果是该接触C1可以具有更大的长度,以提供有效调节所需的表面面积。如果该接触C1由该导体921的暴露部分组成,则这预期不会产生问题。如果该接触C1为环形或圆柱形的接触,则在特定实施方式中,该接触的长度可能变大,以至于限制专业人员在患者***期间操作该引线910的能力。一个解决此种可能问题的方法是将特定的接触C1分为多个子接触,如图11C所示为六个子接触C1a-C1f。在此实施方式中,每一个个别的子接触C1a-C1f可以被连接到图11B所示的同一导体921。相应地,连接到给定导体921的子接触组可以基本作为长接触进行操作,而不限制该引线910的灵活性。
如上所述,上述布置的一个特征是它们易于被设计和制造。例如,根据特定的患者应用,制造者可以使用不同的模板来提供不同的接触间距。除上述作用之外,或者替代地,上述布置可以提供更高的机动性并通过取缔环形电极和/或其它刚性触点,或将这些接触分为子接触来促成植入过程。在其它实施方式中,其它布置可被用于提供接触灵活性。例如,这些接触可以由传导性的硅酮组成,例如,用适合的传导性材料(如铂,铱或另外的贵金属)装载浸渍的硅酮。
图9所示的引线的实施方式的又一个特征是,患者可以仅用单一的双极活化接触对接受有效的治疗。如果超过一对接触为活化状态,每一对接触都可以接收相同的波形,使得活化的接触可以彼此缩短。在另外的实施方式中,该植入的脉冲发生器(图9中不可见)可以作为反馈电极。例如,该脉冲发生器可以包括作为反馈电极的外壳,或该脉冲发生器可以另外携带反馈电极,其具有相对于该脉冲发生器的固定位置。相应地,该活化接触提供的调节可以是单极调节,这和标准SCS治疗相关的更典型的双极刺激不同。
6.0 代表性的编程器结构
本公开的治疗技术的鲁棒特性可以使如上参照图1A-B所述的完整***的其它方面能够被简化。例如,该患者遥控器和该医师编程器可以被大为简化,因为变化信号输送参数的需要被显著降低或完全消除。特别地,在某些实施方式中可以预期,一旦引线被植入,该患者可以接受有效治疗,而采取各种各样的位置和参加宽泛的活动,同时不改变信号幅度或其它信号输送参数。因此,该患者遥控器不必包括任何编程功能,但可以转而包括简单的开启/关闭功能(例如,开启/关闭开关),其进一步描述于美国申请号_______(代理案号66245.8024 US)中,先前以参考方式合并于此。该患者遥控器还可以包括指示器(例如,灯),其可识别该脉冲发生器何时活动。此特征对于和本公开治疗可以特别有用,因为该患者通常将感觉不到感觉异常,除非该***被设置和编程为在治疗信号之外故意产生感觉异常。在特定的实施方式中,医师编程器可以类似方式被简化,尽管在有些情形下可能希望保留至少一定水平的编程能力在该医师编程器上。这种能力可以使该医师在引线移动或患者经历生理变化(例如,瘢痕形成)或生活方式变化(例如,新的活动)的少数情况下选择不同的接触和/或其它信号输送参数,这些情况较为显著,以至于它们需要改变(多个)活化接触和/或其它信号输送参数。
7.0 代表性的调节位置和指征
如上所述的许多实施方式是在用施加于下部胸椎(T9-T12)的调节信号治疗慢性,神经性下腰痛的背景下描述的。在其它实施方式中,具有总体上类似于如上所述参数(例如,频率,脉冲宽度,幅度,和/或作业周期)的调节信号可以被用于其它的患者位置,以解决其它指征。例如,尽管上述方法包括在脊髓中线至DREZ的范围内的横向位置施加调节,在其它实施方式中,该调节可以被施加于从该DREZ水平向外的散孔区域(foramen region)。在其它实施方式中,该调节可以被施加于患者的其它脊髓位置。例如,可以将调节施加于骶骨区域,特别是骶神经进入骶骨的“马尾”区域。小便失禁和大便失禁表现了实例指征,其预期可以用施加到此位置的调节治疗。在其它实施方式中,该调节可以被施加于其它胸椎。例如,可以施加调节于T9以上胸椎。在特定的实施方式中,可以施加调节于T3-T6区域,以治疗心绞痛。可以将调节用于高位胸椎,以治疗与挤压有关的疼痛。可以施加调节于颈椎,以解决慢性区域性疼痛综合症和/或全身疼痛,并且其可被用于替换颈部外科手术。适合的颈部位置包括椎骨C3-C7,包括临界值。在其它实施方式中,可以施加调节于枕骨神经,例如,解决偏头痛。
如上所述,根据上述参数的调节还可以被用于治疗急性和/或慢性伤害性疼痛。例如,根据这些参数的调节能在外科手术期间被使用,以补充和/或替代***(例如,脊髓穿刺)。这种应用可以被用于肿瘤切除,膝外科手术,和/或其它外科手术。类似的技术可以被用于植入装置,以解决手术后疼痛,并可以避免对于局部利度卡因的需求。在更进一步的实施方式中,根据上述参数的调节可被用于解除其它周围神经痛。例如,可以直接施加调节至周围神经以解除幻肢痛。
根据上述内容,应当理解,已经描述于此的此公开的特定实施方式是为了说明,但在不偏离此公开的前提下可以作出各种改变。例如,如上所述的特定参数范围和指征在进一步的实施方式中可以不同。如上所述,专业人员可以避免使用某些步骤,(例如,测绘,试验期间和/或电流导引),但在其它实施方式中,这种步骤可以被用于特定的情形。如上所述参照图9-11C的引线可以具有超过两组接触,和/或在其它实施方式中可以具有其它接触间距。在一些实施方式中,如上所述,施加于该患者的信号幅度可以是恒定的。在其它实施方式中,该幅度可以预定方式变化,例如,通过上调/下调,和/或在多个幅度之中循环。该信号输送部件可以具有硬膜外(epidural)位置,如上参照图1B所示,并且在其它实施方式中,也可以具有硬膜外(extradural)位置。在如上所述的特定实施方式中,当在约T9至约T12的椎骨施加刺激时,具有上述特性的信号预计可以给具有下腰痛和/或腿疼痛的患者提供治疗便利,至少在一些其它实施方式中,可以认为此范围可以为约T5至约L1。
在特定实施方式的背景下所描述的此公开的某些方面可以在其它实施方式中被结合或去除。例如,如上所述,在特定实施方式中,该试验期间,操作室测绘过程,和/或外部调制器可以被去除或者简化。被引导至特定指征的治疗可以在其它实施方式中被组合。此外,尽管与某些实施方式有关的优点已经在那些实施方式的背景下被描述,其它实施方式也可能展现这种优点,而不是所有实施方式必须展现这种优点才落入本公开的范围。相应地,本公开和相关的技术可以包括此处没有明确表达或叙述的其它实施方式。
Claims (10)
1.一种患者治疗装置,包括:
信号发生器,被编程为以频率范围从1.5kHz至100kHz的频率、幅值范围从0.5mA至10mA的幅值以及脉冲宽度范围从10微秒至333微秒的脉冲宽度引导电信号,所述信号发生器具有被设置为和至少一个可植入的信号输送装置;以及
至少一个具有近侧部分和远侧部分的可植入的信号输送装置,所述近侧部分被连接至所述信号发生器并具有被设置为被连接至所述信号发生器的连接器的连接部件,所述远侧部分具有多个电接触以用于沿着患者脊髓传送所述电信号至一个或多个硬脑膜位置,以通过所述电信号的应用减少或抑制所述患者的疼痛,所述信号发生器被配置为引导所述电信号且所述电信号不产生患者感觉异常。
2.如权利要求1所述的装置,其中,所述信号发生器被编程为引导具有电荷平衡的、两相的、方波脉冲的电信号,并且其中以近似相等和相反的电流幅度施加该脉冲的个别的相位。
3.如权利要求1所述的装置,其中,所述信号发生器被编程为以5kHZ至15kHZ的频率引导所述电信号。
4.如权利要求1所述的装置,其中所述信号发生器被编程为以10kHZ的频率引导该电信号。
5.如权利要求1所述的装置,其中直接相邻的电接触彼此隔开8毫米至64毫米。
6.如权利要求1所述的装置,其中所述信号发生器是可植入的信号发生器。
7.如权利要求1所述的装置,其中所述信号发生器是外部信号发生器。
8.如权利要求1所述的装置,其中所述信号发生器被编程为以3kHZ至20kHZ的频率引导所述电信号。
9.如权利要求1所述的装置,其中所述发生器被编程为以3kHZ至10kHZ的频率引导所述电信号。
10.如权利要求1所述的装置,其中所述信号发生器被配置为减少或抑制至少一种慢性下腰痛和腿疼,且所述电信号不产生至少一种的:
(a)被所述患者体内察觉的在沿脊髓的感觉信号中除了下腰痛和腿疼信号外的中断;以及
(b)被所述患者体内察觉的在沿所述脊髓的运动信号中的中断。
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