CN101883606A - 用于神经刺激的***和方法 - Google Patents

用于神经刺激的***和方法 Download PDF

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CN101883606A
CN101883606A CN2008801107901A CN200880110790A CN101883606A CN 101883606 A CN101883606 A CN 101883606A CN 2008801107901 A CN2008801107901 A CN 2008801107901A CN 200880110790 A CN200880110790 A CN 200880110790A CN 101883606 A CN101883606 A CN 101883606A
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S·R·克雷格
P·M·米道斯
M·G·利马
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Imthera Medical Inc
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Abstract

公开了一种神经刺激***和方法，包括以下步骤：将至少一个电极电连接到第一组织；将刺激施加到该至少一个电极；观察第二组织的反应；识别该第一组织上的电极位置，其中当刺激被施加到该至少一个电极时，在第二组织上出现预期反应；以及将该至少一个电极固定在所识别的电极位置处的适当位置。

Description

用于神经刺激的***和方法
本申请分别要求于2007年10月9日、2007年12月29日和2008年8月12日提交的美国专利申请No.60/978,519、No.61/017,614和No.61/136,102的权益，这些专利申请的全部内容在此通过引用的方式被并入。
相关申请的声明
本申请涉及国际专利申请[备案号069737-5005-WO]，该申请也要求了美国专利申请No.60/978,519、No.61/017,614和No.61/136,102的权益。
技术领域
本发明涉及用于调整目标组织的神经刺激(neural stimulation)的***和方法，所述目标组织例如为神经、肌肉或器官。
背景技术
神经刺激在治疗各种急性和慢性医学病症方面是很有用的，这些病症包括疼痛、关节炎、睡眠呼吸暂停、癫痫、失禁和偏头痛，其是影响了全世界数百万人的生理性病症。当前的治疗选择范围从药品介入、诸如用于治疗睡眠呼吸暂停的持续正气压(CPAP)机之类的非侵入方法到侵入性外科手术(surgical)方法。在许多情况下，患者接受和治疗依从性(compliance)比预期的水平要低，反映出作为长期的解决方案当前治疗的低效率。
移植是有前途的替代治疗方法。例如，迷走神经刺激被认为是对大脑中倾向于癫痫发作(seizure activity)的某些区域的连接产生影响。骶骨神经刺激是FDA批准的用于减少尿失禁(urge incontinence)的电刺激治疗。末梢神经的刺激可以帮助治疗关节炎疼痛。作为另一个实例，通过舌下神经(XII)刺激的咽喉扩张已经显示出是一种有效的针对阻塞性睡眠呼吸暂停(OSA)的治疗方法。使用植入式电极来刺激神经。特别地，中间XII神经分叉(即颏舌肌)已经证实显著减小了上呼吸道气流阻力(即，增加咽部尺寸)。
虽然实验显示神经的电刺激消除或改善了某些病症，例如，睡眠呼吸暂停情况下的上呼吸道阻塞，但当前的实施方法通常需要对目标组织进行精确和选择性刺激。因此，需要一种***和方法，该***和方法用于在目标组织(例如，肌肉或神经)上识别最佳位置，并在这些位置上放置植入电极来实现对这些目标组织进行最佳刺激。
发明内容
本发明包括用于调整目标的神经刺激的***和方法，所述目标例如是神经、肌肉或器官。在本发明的实施例中，该方法包括将至少一个电极电连接到第一组织；对该至少一个电极施加刺激；观察第二组织的反应；识别第一组织上的电极位置，其中当对该至少一个电极施加刺激时，第二组织上出现预期反应；以及将该至少一个电极固定在该识别的电极位置处的适当位置。在特定实施例中，刺激施加器(applicator)是一次性的。
刺激可以是电压信号、电流信号，并可以被预编程。在特定实施例中，电压或电流信号是受控电压或受控电流信号。在其他实施例中，计算估计的最小刺激，而在另一个实施例中产生刺激简档(profile)。可从包括神经组织、肌肉组织和器官组织的组中选择被刺激的组织。预期的刺激反应的例子包括呼吸道通畅的变化、神经冲动的至少部分阻塞以及至少一个神经冲动的开始(initiation)。反应可以直接或间接地通过视觉或使用仪器观察到。
在本发明的另一个实施例中，神经刺激***包括电连接到第一组织的至少一个电极；用于对该至少一个电极施加刺激的装置；用于观察第二组织的反应的装置；用于识别第一组织上的电极位置的装置，其中当对该至少一个电极施加刺激时，第二组织上出现预期反应；以及用于将该至少一个电极固定在该识别的电极位置处的适当位置的装置。
在本发明的另一个实施例中，计算机程序产品包括在其上存有计算机可执行指令的计算机可读介质，当在计算机上执行所述计算机可执行指令时，所述计算机可执行指令使计算机执行神经刺激的方法，所述方法包括以下步骤：对电连接到第一组织的至少一个电极施加刺激；观察第二组织的反应；识别第一组织上的电极位置，其中当对至少一个电极施加刺激时，第二组织上出现预期反应。
在本发明的另一实施例中，神经刺激***包括电连接到第一组织的至少一个电极；耦合到该至少一个电极并将刺激输送给该至少一个电极的粗调刺激器；与粗调刺激器通信并具有至少一个传感器的刺激测量子***，该至少一个传感器测量第二组织的反应；以及与刺激测量子***通信的编程子***，该编程子***从包括刺激数据和组织反应数据的组中收集数据。
应该理解到，前述的一般性说明和接下来的详细说明是示例性和解释性的，并旨在提供所要求保护的本发明的进一步解释。
附图说明
附图提供了对本发明的进一步的理解，并被结合到说明书中，构成了说明书的一部分，与说明书一起说明了本发明的实施例，用于说明本发明的原理。在附图中：
图1说明了粗调刺激***的示例性实施例；
图2说明了初始粗调方法的示例性实施例；以及
图3说明了手术后调整方法的示例性实施例。
具体实施方式
本发明涉及一种用于调整刺激电极放置来治疗多种急性和慢性医学病症的粗调刺激***和方法。可通过植入进行治疗的病症包括，但不限于，关节炎、睡眠呼吸暂停、癫痫、失禁和偏头痛。使用例如同时于2007年2月16日提交的美国专利申请No.11/707,104和No.11/707,053所公开的方法和***，可治疗所述示例性病症，这些专利申请的全部内容在此通过引用的方式被并入。以下描述了其他示例性方法和***。
I.电刺激和神经恢复(Neural Recruitment)
电刺激已经成功地应用于刺激末梢感官和运动神经，所述感官和运动神经构成中枢神经***(例如，脊髓和大脑)。通常，用于在神经中引起激活的电刺激遵循几个简单的规则，如下所述：
(a)最接近激活阴极接触的神经在其更远的相邻神经之前被激活(被恢复)；
(b)在具有狭窄纤维的神经之前恢复具有更大纤维直径的神经；以及
(c)神经恢复与电流输送量成正比。
使用电流的电刺激脉冲可电刺激或恢复神经。首先并优先恢复具有最低阈值轴突纤维的神经。当靠近刺激电极接触的神经具有足够低以被电极激励的激活阈值并且在高于其阈值膜电压时被去极化时，出现通过电刺激的对神经轴突的激励。
对该激活阈值的其中一个主要贡献因素(contributor)是神经直径。由于神经的电缆特性，大直径神经纤维具有比较小直径的纤维低的激励阈值，因此更容易被激励。如果神经纤维靠近激励电极并比其他纤维的直径大，那么这些神经纤维更可能被电刺激脉冲恢复。
由于过度激活运动单元的问题，并且由于肌肉激活的相对长的时间常数减少了对高频刺激的需要，因此运动神经激励通常以非常低的刺激速率或频率被执行。利用每一个输送到运动神经的刺激脉冲，受激励的运动单元产生相应收缩。该收缩由肌肉运动单元的物理和电化学特性控制，并且具有比激活它的神经激励更长的时间常数。输送到运动单元的一个脉冲产生一次颤搐，而适当频率的脉冲串或多个脉冲产生具有少量跳动特征的合并收缩。取决于肌肉群，该合成或抽搐频率可以针对大肌肉低到约15Hz或针对较小肌肉高达约80-100Hz。与感觉神经应用相比，例如刺激频率可以是几千赫兹的耳蜗植入刺激，运动神经刺激很慢。
由于运动神经激励的频率非常低，因此可将多个电极复用到单个脉冲发生器。虽然每次仅一个接触是有效的，但使用交织刺激模式(pattern)在同一时间实质上驱动了多个肌肉群。由于肌肉机能相对于神经来说非常慢，所产生的收缩看上去是同时发生且平滑的。
多接触***也允许在相同聚集(pool)中的运动单元群共享激活，从而避免诸如肌肉疲劳这种电刺激肌肉时的普遍问题。多接触***也可以共同激活多个肌肉群来获得预期的肌肉反应。在激活手或前臂肌肉过程中，例如，通过先向第一个接触再向另一个输送交织的脉冲在同一时间激活几个接触，从而激活两个或更多个肌肉群，当被添加时所述两个或更多个肌肉群产生预期方向上的力向量。
然而即使使用复用多接触***，电极仍倾向于激活离电极最近的神经纤维。在这点上，神经纤维是不可选的，并且被强制仅激活那些离接触最近的神经。为了补偿这种能力缺陷来真实地选择性激活最佳神经聚集，一些刺激***取决于传感器来施加最佳次数的刺激，从而仍可获得预期反应。为了激活位于两个接触之间某处选定的神经聚集，但那表示只是预期的神经聚集，期望使用可输送符合的(coincident)单独受控的刺激脉冲的刺激器，而不是使用输送复用连续脉冲的刺激器。
通过输送符合刺激脉冲(coincident stimulation pulse)的刺激器，***可以同时向每个接触输送电流。在特定实施例中，这些电流是独立受控的。***可以为邻近接触的纤维控制这些电流，从而使它们在亚阈值的水平上(即，低于神经的恢复水平)。虽然每个接触周围的场低于神经的恢复或阈值水平，但可以将所述场与来自其他同时通电的电极的场相结合来产生足够强从而激活预期神经的脉冲。因此，可以优先且选择性地激活不是直接位于刺激电极接触之下的神经群体(populations)。由于可以选择性地激活神经，因此不需要传感器来帮助对获得预期结果的刺激输送进行计时。
利用选择性刺激以及多个独立电流源***和站点特定的多接触电极设计，结合患者特定的刺激编程，仅恢复和激活那些负责与无计时相关的激活的(多个)神经纤维部分，为成功的开环刺激应用提供了机会。根据需要，传感器可用于改善刺激计时和输送。传感器可在闭环***、触发开环、开环***、或者三种***的某种组合中使用。
A.可进行植入治疗的采样病例
连同本发明一起使用的方法和***可用于通过刺激与治疗病症相关的神经来治疗多个病症。刺激可以是这样的，即通过激活有刺激性的神经传导来传输刺激，或者刺激可以是这样的，即通过激活抑制神经传导来阻塞神经中的神经传输。在示例性实施例中，该神经是骶骨神经。在另一实施例中，该神经是迷走神经。在另一个实施例中，该神经是末梢神经。可替换地，目标组织可以是肌肉，包括头部和颈部、躯干、上肢和下肢中的肌肉。该目标组织可以是身体器官，例如，肾脏、肝脏、肺、大脑、皮肤、卵巢、肠、动脉和静脉、***、骨头或关节。
B.示例性实施例-阻塞性睡眠呼吸暂停
HGN由多个神经纤维组成，每个神经纤维控制一个或多个舌部肌肉。在某些治疗中，为了使选定的舌部肌肉产生动作，刺激选定的HGN神经纤维。以下本发明描述将电极放置在目标组织上以产生预期的刺激反应的粗调刺激***和方法。
II.粗调刺激***
图1示出了粗调刺激***100的示例性实施例。该***具有至少一个电极110、粗调刺激器120、刺激测量子***130和编程子***140。每个描述如下。
A.粗调刺激器
在图1所示的示例性实施例中，粗调刺激器120配置为产生将传送给至少一个植入式电极110的刺激。粗调刺激器120刺激植入式电极110，该植入式电极在某种意义上相当于要植入的装置(例如可植入脉冲发生器)。如本文所描述，电极110可以是单独的电极、多个电极或至少一个电极阵列。电极和粗调刺激器的实例包括，但不限于，分别于2007年10月9日、2007年12月29日和2008年8月12日提交的美国专利申请No.60/978,519、No.61/017,614和No.61/136,102中描述的电极和可植入脉冲发生器，这些专利申请的全部内容在此通过引用的方式被并入。
在特定实施例中，粗调刺激器120允许医生、医生助理或技师(这里一般称作医生)开始或停止刺激，并向刺激测量子***130询问适当功能的信息。在特定示例性实施例中，粗调刺激器120还允许患者指示***来执行这些功能。在特定实施例中，如果，例如粗调刺激器与具有外部控制器的IPG(未示出)一起使用，则粗调刺激器120显示到刺激器的通信和电力链路的状态以及任何外部控制器(未示出)的状态。在特定实施例中，医生或患者也可以选择刺激器的操作模式，例如患者想要睡觉时的睡眠模式，患者参与上述一般水平的身体活动时的练***。
在特定示例性实施例中，粗调刺激器120的刺激是受控电压或受控电流信号，其可以被预编程。在特定实施例中，粗调刺激器120通过RF或其他无线信号被提供电力和/或控制。在特定实施例中，粗调刺激器120以一个或多个刺激信号的形式向至少一个电极110发送刺激。在其他实施例中，刺激可被发送到至少两个电极110，或电极阵列110。在其他实施例中，刺激器为植入程序的至少一部分向电极110发送持续或接近持续的刺激。非限制性的实例包括一个或多个脉冲、脉冲序列、正弦波、恒流源信号或其他本领域技术人员知道的受控刺激形式。因此，可基于患者的需要控制目标组织的刺激以及它对反应组织的影响，并且该目标组织的刺激以及它对反应组织的影响不限于特定波形。
在本发明的一个实施例中，粗调刺激器120可以可选地包括密码块(未示出)。密码块可用于只对需要的电极110编码唯一的信号，而不影响另一个刺激器120控制的其他电极。因此，在相同的临近地区存在两个或更多个粗调刺激器120，密码块创建将只与需要的一个或多个电极110对接的唯一信号。
在另一个实施例中，粗调刺激器120也可以包括数据存储单元和/或记录单元(未示出)来分别存储和/或记录数据。粗调刺激器120可以包括计算机接口(例如，无线链路、USB端口、串行端口或火线(fire wire))来收集或转移数据到外部***。在特定实施例中，粗调刺激器120是一次性的。
B.刺激测量子***
在图1所示的示例性实施例中，刺激测量子***130测量目标组织对施加的刺激的反应。在特定实施例中，刺激来自一个或多个植入式电极110，所述电极接收来自粗调刺激器120的刺激。刺激反应可通过直接、间接或两者的某种组合进行测量。可通过使用与植入物相集成、在植入物之外或两者的某种组合的传感器来进行测量。以下将讨论直接和间接感测、以及集成的传感器和外部传感器。
1.直接测量
直接测量是一个或多个直接影响呼吸道通畅的因素的测量。直接影响呼吸道通畅的因素包括，但不限于，口腔尺寸、舌突或肌肉弹性，以及呼吸气流(即，呼吸道气流)。有很多测量这些因素的不同方法。这些因素可以通过视觉测量，或可以使用机械、电子或机电传感器来测量。例如，可使用咽声反射(acousticpharyngometry)来测量口腔尺寸。通过使用例如一个或多个邻近的传感器、加速计、或压力传感器可测量舌突或肌肉弹性。这些传感器可以放在嘴、耳、颈或其他本领域技术人员所知的适当位置中。也可以通过使用摄影、超声波或本领域技术人员所知的其他成像形式的软组织成像装置来测量舌突或肌肉弹性。其他方式还包括通过内窥镜观察，或在舌头表面施加荧光染色图案并使用紫外线或荧光灯光源照亮舌头表面。
呼吸气流可通过机电传感器或上述的某种组合进行机械、电测量。一种方式是使用鼻腔插管或热控管。其他方式包括具有热电偶的呼吸换能器、压电热传感器、压力和差压传感器、或其他本领域技术人员已知的流量传感器。呼吸气流也可以通过呼吸速率计或呼吸感应体积描记器(respiratory inductanceplethysmograph)来测量。这些方式只是示例性的，并不对所讨论的内容进行限制。在不脱离本发明的范围的情况下可以使用本领域技术人员知道的其他方式。
2.间接测量
间接测量是对一个或多个被呼吸道通畅影响的指标的测量。指标实例包括，但不限于，血氧水平、血压、心律、躯干运动(用于感测例如相应的呼吸缓解)，以及打鼾。许多不同的传感器可以测量这些间接指标。可使用例如外部动脉张力测量法来进行间接测量。在其他例子中，血氧水平可以通过氧气传感器、脉冲测氧法、红外(IR)线传感器、或耳垂监测单元来测量。打鼾可使用例如差压传感器、振动传感器或麦克风来测量。也可以使用鼻腔插管来检测打鼾。
3.传感器
直接或间接感测和测量呼吸道通畅的能力增加了评估患者对刺激模式的反应的容易度(ease)和准确度。在图1所示的示例性实施例中，将数据输入到刺激测量子***130的一个或多个传感器可以在电极110或电极阵列110、粗调刺激器120或IPG(未示出)的内部。在其他示例性实施例中，该一个或多个传感器可以在电极110或电极阵列110、粗调刺激器120或IPG(未示出)的外部。在特定实施例中，至少一个内部传感器是MEMS装置，例如压力传感器或加速计。在另一个实施例中，至少一个内部传感器是能够记录与肌肉弹性变化相关的电传感器。传感器信息(例如来自内部和/或外部传感器)可以实时地通过双向链路(例如本领域技术人员已知的RF或其他无线链路)或通过使用置于皮肤表面之下的接口进行检索。在特定实施例中，所述传感器在电极110或IPG的外部，但仍在患者的内部。例如，外部传感器可位于耳部、鼻腔、咽喉或其他本领域技术人员已知的测量点。外部传感器也可以位于患者的外部，例如在医学设备、实验室或患者家中时。
C.编程子***
在图1的示例性实施例中，编程子***140在粗调过程中收集关于所施加的刺激的数据。编程子***140也可以包含预编程的刺激数据，该数据可用于将刺激施加到至少一个电极110。在其他实施例中，编程子***140收集关于刺激反应(例如组织反应)的数据，而在其他实施例中编程子***同时收集关于施加的刺激和刺激反应的数据。该数据则可用于编程供舌下神经植入下载的用户特定刺激模式，以扩张呼吸道并减少睡眠呼吸杂乱/阻塞性睡眠呼吸暂停。在特定实施例中，例如，至少一个传感器收集数据，该数据为突出肌肉a，c，f没有受给定的刺激的影响，但平坦肌肉b，d，e在以nHZ频率下刺激神经纤维x，y，z时受到刺激。在特定示例性实施例中，传感器信息存储在刺激测量子***130的传感器存储器(未示出)中。测量的数据被传给编程子***140或由该***获得，并记录在该***中，与所施加的刺激模式相关联。
感测的信息数据也可以直接传送给编程子***140。一旦收集并关联了该数据，编程子***140基于获得的信息产生刺激简档。刺激简档可下载到IPG(未示出)或粗调刺激器120。来自这些传感器(内部或外部)的信号可以(例如，由医生、患者或其他用户)通过直接观察进行关联，或可通过软件算法进行数字化或分析来创建刺激简档。该简档可用于施加刺激，该刺激在目标组织中产生预期反应。在特定实施例中，编程子***140中的软件生成算法来建议引起预期刺激反应的电极组合和刺激水平。
III.初始粗调
图2说明了初始粗调方法200的示例性实施例。在所示示例性方法中，在步骤210将至少一个电极110置于目标组织上或附近的初始位置。电极110不需要与目标组织物理连接或接触。电极110只需要足够接近目标组织以与组织建立电连接。目标组织可以是患者身体的神经、肌肉、或器官。在特定实施例中，目标组织是舌下神经。在步骤220中，至少一个刺激被施加到至少一个电极110。可手动选择刺激，或对刺激进行预编程。在所示的示例性方法中，通过粗调刺激器120施加刺激，但在其他实施例中可以从另一个源施加刺激。在特定实施例中，粗调刺激器120适用于手术室环境。适用于手术室环境的设备的示例性指导准则在下面的文献中被描述：2007年1月3日发表的Draft Guidancefor Industry and FDA Staff：Radio-Frequency Wireless Technology in MedicalDevices，该文献的全部内容在此通过引用的方式被并入。配置为在手术室中无线使用的刺激器无需无线操作，但如果希望的话是可以的。
变化的刺激模式被施加到至少一个电极110，所述刺激模式包括电极接触的排列，并输送变化电流振幅、持续时间和/或频率的刺激。在特定实施例中，这些变化的刺激模式在医生或技师的控制下被施加，并可以被预编程。这些变化的刺激模式对控制舌位、肌肉弹性、舌后呼吸道的尺寸和通畅的神经纤维具有不同的影响。为了识别是哪些神经纤维在舌部的肌肉中产生预期的刺激反应来扩张呼吸道，对感兴趣的每个目标神经纤维群体单独施加刺激。在特定实施例中，记录电极位置、施加的刺激以及刺激反应来帮助识别电极在神经上的提供最佳刺激的定位。
施加不同水平的神经纤维刺激来识别引起减少生理病症痛苦所需要的适当肌肉动作所需的最小刺激。取决于肌肉反应以及受刺激的不同神经或神经纤维，不同刺激水平经常引起不同反应。示例性刺激模式是本领域已知的，或在美国专利申请No.11/707,104和No.11/707,053中给出教导。
步骤220中施加的刺激可以有许多形式。虽然可以在高频下施加刺激，但是将刺激频率降低到例如平滑的、强直性且舒适的收缩所需的最低频率减少了整体功耗，并帮助减少电刺激所引起的肌肉疲劳。刺激也可以在一个或多个频率下以单个脉冲、脉冲串、或多个脉冲的形式被输送。每个频率可以针对大目标肌肉低到大约15Hz，或者针对较小肌肉高至大约80-100Hz。在其他实施例中，刺激频率可以从低的1Hz调整到最大值100Hz。可替换地，对刺激进行复用，并且在其他实施例中，在以符合脉冲输送刺激。刺激可以输送到电极110上的几个接触(未示出)，或者可以通过输送交织脉冲到一个接触然后再到下一个来顺序地施加刺激，从而创建多个电场，当被添加时所述多个电场在预期方向上产生力向量，以便以预期的刺激水平刺激目标组织。
在步骤230，医生、医生助理或技师(本文一般称为医生)检查是否获得了预期的刺激反应。该步骤在步骤220期间或之后执行。在特定示例性实施例中，预期反应是神经冲动阻塞(例如通过对抑制的神经传导进行激励)。在特定的其他示例性实施例中，预期反应是呼吸道通畅的变化。在刺激施加的过程中或之后直接或间接地观察呼吸道通畅的变化。对预期刺激反应的检查有助于确定哪些接触以及电流模式的组合是最期望的。接下来可根据呼吸暂停的严重性来调整刺激参数。
可通过其他电子装置，例如计算机或其他仪器，或者甚至通过视觉观察来使用刺激测量子***130测量刺激反应。测量可以是直接的或间接的。刺激测量子***130和测量装置在本申请的其他地方被描述，并且在此不再重复。在所示的示例性实施例中，粗调刺激器120将刺激施加到至少一个电极110，医生检查是否获得了预期的刺激反应(例如，在呼吸道通畅中的舌部动作变化)230。在特定实施例中，这帮助确定哪些接触以及电流模式的组合是患者预期的。在其他示例性实施例中，预期反应是神经冲动的至少部分阻塞，在其它示例性实施例中，预期反应是神经冲动的开始。产生预期反应的刺激模式则可存储在植入物、患者控制设备、安全档案(secure archive)或编程子***140中。该刺激可由医生选择，或可被预编程。
如果没有获得预期的刺激反应，则医生在步骤240决定是否施加额外的刺激。如果医生选择施加额外的刺激240，则医生使用预期的(多个)刺激模式来重复步骤220。可替换地，或除了步骤240之外，医生在步骤250决定是否需要电极重新定位。如果选择重新定位，则医生通过例如沿着目标组织移动至少一个电极110来选择新位置，并从步骤210开始。
如果不想重新定位，则医生在步骤260决定通过对处于其当前位置的电极施加刺激是否获得了可接受的结果。如果是，则医生在步骤270在适当的位置固定电极。如果不是，则医生在步骤280移走电极。可使用外科工具将电极固定在适当的位置，所述外科工具例如是缝合线、胶水、扣件或本人员已知的其他工具。可利用额外的刺激电极110执行该方法，以及利用电极阵列110执行该方法。不需要按照所示的顺序来执行这些步骤，也不需要执行所有这些步骤。该方法只是示例性的，并且不限于所描述的内容。
IV.手术后的调整
一旦伤口愈合，可开始手术后的调整。一旦患者和伤口治愈，医生开始植入编程来最大化夜间舌后或咽喉呼吸道。编程可包括刺激值的范围、开启植入和刺激开始之间的可编程延迟、随时间变化的刺激强度的坡度(ramp)以及预定间隔后的自动关断。可以通过无线链路为初始试用以及供患者使用的最终刺激程序下载编程到植入物，或者可以用USB、串行连接或其他连接来下载该编程。编程参数可包括刺激值的全部范围、开启植入和刺激开始之间的可编程延迟、随时间变化的刺激强度的坡度以及预定间隔后的自动关断。在其他实施例中，IPG自身可用于产生粗调过程中使用的信号和刺激模式。
图3说明了手术后的调整方法300的示例性实施例。在所示的示例性方法的步骤310中，当患者清醒且上呼吸道(URT)打开时，施加电极刺激。在步骤320，响应于所施加的刺激来测量舌头位置。在示例性实施例中，利用舌突标定设备来测量舌头位置。该设备放在嘴部前端并由牙齿或嘴唇或其他方法保持在适当的位置。在某些方法中，舌突设备被配置成使用例如压力传感器来测量前端舌部推力。
在步骤330询问患者来评估响应刺激的舌部位置的相对舒适性。如果没有获得预期的刺激反应，可用另一个刺激来重复步骤310-330。在步骤340医生评估刺激反应是否是预期的。当获得预期的刺激反应时(即产生扩张呼吸道或者呼吸道通畅变化而不会对患者引起不适的刺激)，在步骤350保存该刺激程序供以后使用。可由医生、医生助理、技师、或者甚至是患者对刺激进行编程。
另一个示例性手术后调整方法是在舌部具有普通日间健康状态时使用电神经图传感器记录当前神经活动的水平。在这种方法下，当患者清醒时记录来自目标组织(例如舌下神经)的信号。该记录可以在患者正常的日常工作期间进行，或者可以当患者在实验室或医疗设施中时进行。从电神经图传感器收集的信息可用于准备刺激程序，该程序模拟将在患者睡眠期间使用的日间神经信号来治疗睡眠呼吸暂停。电神经图传感器的使用只是示例性的。在不脱离本发明的范围的情况下，本领域的技术人员已知的其他传感器也可用于获得上述信息来创建预期的刺激程序。
另一种途径或示例性方法是使用最小化URT阻塞、打鼾以及呼吸暂停和或呼吸不足事件的激励协议来对实验室中的HGN植入物进行编程，以便最大化URT通畅。为了初始试用以及供患者使用的最终刺激程序，可将编程通过RF链路下载到植入物。
本领域技术人员应当认识到，在不脱离本发明范围的情况下，可以对本发明的设备进行各种修改和变型。因此，本发明旨在覆盖本发明的修改和变型。

Claims (30)

1.一种神经刺激方法，包括以下步骤：
将至少一个电极电连接到第一组织；
将刺激施加到该至少一个电极；
观察第二组织的反应；
识别第一组织上的电极位置，其中当刺激被施加到该至少一个电极时，在第二组织上出现预期反应；以及
将该至少一个电极固定在所识别的电极位置处的适当位置。
2.根据权利要求1的神经刺激方法，其中所施加的刺激是电压信号。
3.根据权利要求1的神经刺激方法，其中所施加的刺激是受控电压信号。
4.根据权利要求1的神经刺激方法，其中所施加的刺激是电流信号。
5.根据权利要求1的神经刺激方法，其中所施加的刺激是受控电流信号。
6.根据权利要求1的神经刺激方法，其中所施加的刺激被预编程。
7.根据权利要求1的神经刺激方法，其中刺激施加器是一次性的。
8.根据权利要求1的神经刺激方法，还包括向该至少一个电极施加额外刺激的步骤。
9.根据权利要求1的神经刺激方法，还包括重新定位该至少一个电极的步骤。
10.根据权利要求1的神经刺激方法，还包括计算用来获得预期反应的估计的最小刺激水平的步骤。
11.根据权利要求1的神经刺激方法，还包括产生刺激简档的步骤。
12.根据权利要求11的神经刺激方法，其中刺激简档包括建议的电极组合和得到预期反应的刺激水平。
13.根据权利要求1的神经刺激方法，其中第一和第二组织选自包括神经组织、肌肉组织以及器官组织的组。
14.根据权利要求13的神经刺激方法，其中第一组织是神经组织。
15.根据权利要求14的神经刺激方法，其中神经组织是舌下神经纤维。
16.根据权利要求13的神经刺激方法，其中第二组织是舌部肌肉组织。
17.根据权利要求16的神经刺激方法，其中舌部肌肉组织是舌部平整肌肉。
18.根据权利要求16的神经刺激方法，其中舌部肌肉组织是舌部突出肌肉。
19.根据权利要求1的神经刺激方法，其中所述预期反应是呼吸道通畅的变化。
20.根据权利要求1的神经刺激方法，其中所述预期反应是神经冲动的至少部分阻塞。
21.根据权利要求1的神经刺激方法，其中所述预期反应是至少一个神经冲动的开始。
22.根据权利要求1的神经刺激方法，其中在视觉上观察第二组织的反应。
23.根据权利要求1的神经刺激方法，其中使用仪器观察第二组织的反应。
24.根据权利要求1的神经刺激方法，其中第二组织的反应被直接观察。
25.根据权利要求1的神经刺激方法，其中第二组织的反应被间接观察。
26.根据权利要求1的神经刺激方法，其中第二组织的反应通过在患者内部的传感器被观察。
27.根据权利要求1的神经刺激方法，其中第二组织的反应通过在患者外部的传感器被观察。
28.一种神经刺激***，包括：
电连接到第一组织的至少一个电极；
用于向该至少一个电极施加刺激的装置；
用于观察第二组织的反应的装置；
用于识别第一组织上的电极位置的装置，其中当刺激被施加到该至少一个电极时，在第二组织上出现预期反应；以及
用于将该至少一个电极固定在所识别的电极位置处的适当位置的装置。
29.一种包括计算机可读介质的计算机程序产品，其中该计算机可读介质存有计算机可执行指令，当在计算机上执行所述计算机可执行指令时，所述计算机可执行指令使计算机执行包括以下步骤的神经刺激方法：
将刺激施加到与第一组织电连接的至少一个电极；
观察第二组织的反应；以及
识别第一组织上的电极位置，其中当刺激被施加到该至少一个电极时，在第二组织上出现预期反应。
30.一种神经刺激***，包括：
电连接到第一组织的至少一个电极；
粗调刺激器，该粗调刺激器耦合到该至少一个电极并向该至少一个电极输送刺激；
与粗调刺激器通信的刺激测量子***，该刺激测量子***具有至少一个传感器，该至少一个传感器测量第二组织的反应；以及
与刺激测量子***通信的编程子***，该编程子***从包括刺激数据和组织反应数据的组收集数据。
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Application publication date: 20101110