CN104736053A - 植入设备与外部设备之间的内部共振匹配 - Google Patents
植入设备与外部设备之间的内部共振匹配 Download PDFInfo
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- CN104736053A CN104736053A CN201380048628.2A CN201380048628A CN104736053A CN 104736053 A CN104736053 A CN 104736053A CN 201380048628 A CN201380048628 A CN 201380048628A CN 104736053 A CN104736053 A CN 104736053A
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Abstract
一种配置成植入对象的身体中的单元包括:载体;与该载体相联系的可植入电路;安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分能量提供给该可植入电路的天线;以及与该载体相联系、从该可植入电路接收能量的至少一个组件。其中,该可植入电路和该天线具有与外部电路的外部共振频率失配,以考虑到作为植入对象的身体中的结果的共振频率变化的内部共振频率。
Description
交叉引用相关申请
本申请要求2012年7月26日提交的美国临时专利申请第61/676,327号的利益,在此通过引用并入其公开内容。
技术领域
本公开的实施例一般涉及调节神经的设备和方法。更具体地说,本公开的实施例涉及向植入单元传送能量的设备和方法。
背景技术
神经调节展示了通过与身体自身的自然神经过程交互治疗许多生理状况和紊乱的机会。神经调节包括电或化学地抑制(例如,阻止)、刺激、修正、调控、和治疗变更中央、***、或自主神经***中的活动。通过调节神经***的活动,例如,通过刺激神经或阻止神经信号,可以达到几种不同目的。可以以适当次数刺激运动神经元,使肌肉收缩。例如,可以阻止感觉神经元,以便减轻痛苦,或例如,可以刺激感觉神经元,以便向对象提供信号。在其它例子中,可以使用自主神经***的调节来调整像心率和血压那样的各种不随意生理参数。神经调节可以提供治疗一些疾病或生理状况的机会,下面详细描述这些疾病或生理状况的少数几个例子。
阻塞性睡眠呼吸暂停(OSA)是可以应用神经调节的状况之一。OSA是以在睡眠期间上呼吸道局部或完全阻塞的反复发作为特征的呼吸紊乱。在人没有OSA的睡眠期间,环咽肌在睡眠期间变松驰并逐渐扁塌,使气道变窄。气道变窄限制了睡眠者呼吸的有效性,使血液中的CO2水平上升。CO2的升高导致环咽肌收缩,将气道打开,恢复正常呼吸。负责上呼吸道扩张的最大环咽肌是颏舌肌,它是舌头中的几块不同肌肉之一。颏舌肌负责舌头的向前运动、和前咽壁的***。在患有OSA的患者中,考虑到与正常个体相比打开气道的不足反应和收缩,环咽肌的神经肌肉活动与正常个体相比减弱了。这种反应的缺乏促使部分或完全气道阻塞,这显著地限制了睡眠者呼吸的有效性。在OSA患者中,夜间往往发生几次气道阻塞事件。由于阻塞,血液中的氧气水平逐渐下降(血氧不足)。血氧不足导致夜间觉醒,这可以通过EEG(脑电图)记录下来,表明大脑从某个睡眠阶段醒来变成短暂觉醒。在觉醒期间,存在化解气道阻塞的有意识呼吸或喘气。作为对血氧不足的反应,也往往通过释放像肾上腺素和去甲肾上腺素那样的激素发生交感紧张性活动率的增加。作为交感紧张性增加的结果,心脏增大,试图抽运更多的血液和提高血压和心率,进一步使患者觉醒。在化解了呼吸暂停事件之后,随着患者回到梦乡,气道再次扁塌,导致进一步的觉醒。
这些重复的觉醒与重复的血氧不足结合,导致患者睡眠被剥夺,这又导致白天昏昏欲睡,使认知功能恶化。在严重的患者身上,这种循环本身可以每晚重复高达数百次。因此,夜间交感紧张性的重复起落和血压升高的发作经过整个白天演变成高血压。随后,高血压和提高的心率可以引起其它疾病。
治疗OSA的努力包括持续气道正压(CPAP)治疗,这要求患者穿戴将空气吹入鼻孔中保持气道打开的面罩。其它治疗选项包括将刚性插件植入软腭中,以提供结构支撑、气管切口、或组织消融。
可以应用神经调节的另一种状况是发生偏头痛。头中的痛觉经由枕神经,尤其较大的枕神经、和三叉神经传递到大脑。当对象像在偏头痛期间那样,经历头痛时,抑制这些神经可以为降低或消除痛感服务。
也可以将神经调节应用于患有高血压的患者。身体中的血压通过多种反馈机制来控制。例如,颈动脉中的颈动脉体中的压力感受器对颈动脉内的血压变化敏感。当血压升高时,压力感受器生成经由舌咽神经传导到大脑的信号,向大脑传达激活身体的调控***以便,例如,通过改变心率、和血管扩张/血管收缩降低血压的信号。相反,肾动脉上和周围的副交感神经纤维生成传送到肾脏,引发像盐潴留和血管紧张素的释放那样,使血压升高的行为的信号。调节这些神经可以提供对血压施加一些外部控制的能力。
上文仅仅是可以从神经调节中受益的状况的少数几个例子,但是,下文所述的本发明的实施例未必局限于只治疗上述状况。
发明内容
本公开的一些实施例可以包括配置成植入对象的身体中的单元。该单元可以包含:载体;与该载体相联系的可植入电路;安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分能量提供给该可植入电路的天线;以及与该载体相联系、从该可植入电路接收能量的至少一个组件。其中,该可植入电路和该天线具有与外部电路的外部共振频率失配,以考虑到作为植入对象的身体中的结果的共振频率变化的内部共振频率。
在一些其它实施例中,配置成植入对象的身体中的单元可以包含:载体;与该载体相联系和具有可调电容的可植入电路;安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分接收能量传送给该可植入电路的天线;以及与该载体相联系、和被配置成接收传送给该可植入电路的至少一些能量的至少一个组件。该可植入电路的内部共振频率可以通过在将该单元植入对象的身体中之前改变该可植入电路的可调电容有选择地设置,引起该可植入电路的内部共振频率与配置成位于对象的身体外部的外部电路的外部共振频率之间的共振频率偏移。
制造要植入对象的身体中的植入单元的方法可以包括根据作为将该植入单元植入对象的身体中的结果的内部共振频率的预期共振变化、和根据配置成将能量从对象身体之外的地点传送给该可植入电路的外部电路的外部共振频率,为与该植入单元相联系的天线和可植入电路确定所希望初始共振频率。该方法还可以包括调整与该可植入电路相联系的至少一个电容,以便将该天线和该可植入电路的内部共振频率有选择地设置成所希望初始共振频率。
本发明的另外特征部分阐述在如下的描述中,以及部分可从该描述中明显看出,或可以通过本发明的实践得知。
要明白的是,前面的一般描述以及如下的详细描述都只是示范性的和说明性的,而不是如要求保护地限制本发明。
附图说明
并入本申请中和构成本申请的一部分的附图例示了本公开的几个实施例,并且与该描述一起,用于说明本文公开的实施例的原理。
图1是按照本公开的一个示范性实施例的植入单元和外部单元的示意性例示。
图2是带有按照本公开的一个示范性实施例的植入单元和外部单元的患者的局部横截面侧视图。
图3是例示包括按照本公开的一个示范性实施例的植入单元和外部单元的***的示意性方块图。
图4是按照本公开的一个示范性实施例的植入单元的示意性顶视图。
图5是植入单元的一个可替代实施例的示意性顶视图。
图6是按照本公开的一个示范性实施例的植入单元和外部单元的电路图。
图7是例示按照一个示范性公开实施例的非线性谐波的曲线图。
图8是按照一个示范性公开实施例,可以用在作为函数耦合确定能量传输中的物理量的曲线图。
图9是按照另一个示范性公开实施例,可以用在作为函数耦合确定能量传输中的物理量的曲线图。
图10A是按照本公开的一个示范性实施例的外部单元的示意性侧视图。
图10B是按照图10A的示范性实施例的外部单元的示意性顶视图。
图11是描绘应用改进D类放大器的自共振发送器的电路图。
图12是描绘脉冲模式自共振发送器的电路图。
具体实施方式
现在详细介绍其例子例示在附图中的本公开的示范性实施例。只要有可能,在所有附图中将使用相同标号来指代相同或相似部分。
本公开的一些实施例涉及含有初级天线的设备(也称为外部单元),该初级天线对含有次级天线的可植入设备(也称为植入单元)无线供电。当两个天线处在共振频率匹配中时,外部单元与植入单元之间能量传送的效率可能高于与外部单元的初级天线相联系的共振频率不与植入单元的次级天线相联系的共振频率匹配的环境。但是,在一些情况下,与植入单元上的次级天线相联系的共振频率由于多种原因,包括,例如,作为与植入对象身体中相联系的作用的结果,可能随时间而变。本公开描述了配置成改变或缩小与植入单元的次级天线相联系的共振频率和与外部单元的初级天线相联系的共振频率之间的频率失配的实施例。
可植入设备可以应用于,例如,调节对象身体中的至少一种神经。神经调节包括电或化学地抑制(例如,阻止)、刺激、修正、调控、和治疗变更中央、***、或自主神经***中的活动。神经调节可以采取神经刺激的形式,神经刺激可以包括向神经提供能量,产生足以将神经激活的电压变化,或传播它自身的电信号。神经调节还可以采取神经抑制的形式,神经抑制可以包括向神经提供足以防止神经传播电信号的能量。神经抑制可以通过恒定地应用能量来进行,也可以通过应用足够的能量以便在应用之后的某个时间内抑制神经的功能来进行。神经调节的其它形式可以修正神经的功能,使敏感度加强或减弱。如本文所提及,神经的调节可以包括整个神经的调节和/或一部分神经的调节。例如,可以进行运动神经元的调节,以便只影响作为应用能量的地点的末端的那些神经元部分。
在患有OSA的患者中,例如,神经刺激的初级目标反应可以包括舌肌(例如,包括颏舌肌)的收缩,以便使舌头移动到不阻断患者气道的位置。在偏头痛的治疗中,可以使用神经抑制来降低或消除痛感。在高血压的治疗中,可以使用神经调节来提高,降低,消除或要不然修正身体产生的神经信号,以便调控血压。
虽然本公开的实施例可能为用在出现特定状况的患者中而公开,但这些实施例可以结合可能希望神经调节的任何患者/身体部分来使用。也就是说,除了患有OSA、偏头痛、或高血压的患者之外,本公开的实施例可以用在许多其它领域中,包括,但不限于:大脑深度刺激(例如,癫痫症、帕金森综合症、和抑郁症的治疗)、心脏起搏、胃肌肉刺激(例如,肥胖症的治疗)、背痛、失禁、痛经、和/或可能受神经调节影响的任何其它状况。
图1例示了按照本公开的一个示范性实施例的植入单元和外部单元。植入单元110可以被配置成植入对象(例如,患者)中,允许调节神经115的地点中。可以让植入单元110这样处在受益者中,使得在植入单元110与神经115之间存在中介组织111。中介组织可以包括肌肉组织、***、器官组织、或任何其它类型的生物组织。因此,植入单元110的地点无需与神经115接触,以便实现有效的神经调节。植入单元110还可以直接处在与神经110相邻的地点,以便不存在中介组织111。在进一步的实施例中,可以结合可能希望调节的任何神经放置植入单元。例如,可以将枕神经,较大的枕神经、和/或三叉神经的调节用于治疗像偏头痛引起的痛感那样,头中的痛感。可以将肾动脉(即,肾神经)、迷走神经、和/或舌咽神经上和周围的副交感神经纤维的调节用于治疗高血压。另外,可以调节包括运动神经元、感觉神经元、交感神经元和副交感神经元的***神经***(脊柱和颅骨两者)的任何神经,以便达到所希望效果。
在进一步的实施例中,可以结合可能希望调节的任何神经放置植入单元。例如,可以将枕神经,较大的枕神经、和/或三叉神经的调节用于治疗像偏头痛引起的痛感那样,头中的痛感。可以将肾动脉(即,肾神经)、迷走神经、和/或舌咽神经上和周围的副交感神经纤维的调节用于治疗高血压。另外,可以调节包括运动神经元、感觉神经元、交感神经元和副交感神经元的***神经***(脊柱和颅骨两者)的任何神经,以便达到所希望效果。
图2例示了在患有OSA的患者中传输能量的神经调节***的一个示范性实施例。该***可以包括可以配置成位于患者外部的外部单元120。如图2所例示,外部单元120可以配置成附在患者100身上。图2例示了在患有OSA的患者中,外部单元120可以配置成放置在患者下巴的下面和/或患者颈部的前面。放置地点的适用性可以通过下面更详细讨论的外部单元120与植入单元110之间的通信来确定。在可替代实施例中,为了治疗除了OSA之外的其它状况,外部单元可以配置成附在患者身上的任何合适地方上。譬如:在患者颈部的后部上,以便与偏头痛治疗植入单元通信;在患者腹部的外部上,以便与胃调节植入单元通信;在患者的背部上,以便与肾动脉植入单元通信;和/或取决于特定应用的要求,在患者皮肤上的任何其它适当外部地点上。
在一些实施例中,外部单元120可以配置成位于患者的外部,直接与患者的皮肤112接触,或接近患者的皮肤112。于是,外壳的至少一侧可以包括粘合材料。该粘合材料可以包括生物相容材料,以及可以允许患者将外部单元粘合在所希望地点上和根据使用的完成移走外部单元。该粘合剂可以配置成单次或多次用于外部单元。适当的粘合材料可以包括,但不限于,生物相容胶、淀粉、弹性体、热固性塑料、和乳剂。
图3是示范性设备(例如,外部单元120)和示范性可植入单元(例如,植入单元110)的示意性表示。在一个实施例中,植入单元110可以包含载体(例如,例示在图4中的柔性载体161)、可植入电路(例如,例示在图6中的电路180)、天线(例如,次级天线152)、和从可植入电路接收能量的至少一个组件(例如,植入电极158a,158b)。在植入对象的身体中之前,可植入电路和次级天线提供某个共振频率。但是,当植入对象的身体中时,这种共振频率可能由于,例如,与将植入单元放置在对象的身体中相联系的各种作用而变化。在一些实施例中,植入之后与植入单元相联系的共振频率的变化可能是已知的,可预测的,或已预测到等。为了考虑共振频率的这种变化(或共振频率漂移),可以将植入单元制造成具有与配置成与植入单元的可植入电路通信的外部电路(例如,电路170)的共振频率失配、与天线和可植入电路相联系的共振频率。在将植入单元放置在对象的身体中以及发生与植入单元相联系的共振频率的变化之后,可以消除这种共振频率失配。
植入单元可以由适合植入对象的身体中的任何材料形成。在一些实施例中,植入单元可以包括由柔性、生物相容材料形成的载体,以提供柔性载体161。在一些实施例中,该柔性载体可以起形成,放置,布置等植入单元的各种组件的植入单元的基底的作用。可以用在形成柔性载体中的材料包括,例如,硅胶、聚酰亚胺化合物、苯基三甲氧基硅烷(PTMS)、聚甲基丙烯酸甲酯(PMMA)、聚氯代对二甲苯、聚酰亚胺、液态聚酰亚胺、多层聚酰亚胺、黑色环氧树脂、聚醚醚酮、液晶聚合物(LCP)、聚酰亚胺胶带等。植入单元110可以进一步包括其包括像铜、铂、钛、或任何其它生物相容材料或这些材料的组合物那样的导电材料的电路。植入单元110和柔性载体161还可以被制造成具有适合植入在患者皮肤下面的厚度。植入单元110可以具有小于大约4mm(毫米)或小于大约2mm的厚度。
植入单元和外部单元每一个都可以包括直接或间接与它们各自天线电连接、包括至少一条导线、电组件、电阻、电感器、和/或电容器等的电路。在一些实施例中,植入单元的电路可以包括,例如,电容器151、二极管156、和可以用于非线性变更在电路中产生的谐波的谐波修正电路154。可植入单元的电路可以包括其包括,例如,电极、开关、换能器、传感器、检测器、天线、二极管等的其它电组件或与其连接。可以包括在植入单元110中的电路的一个例子是描绘在图6中的电路180。
在一些实施例中,该电路可以包括配置成有选择地包括和有选择地从电路中排除的至少一个电容器(例如,两个电容器、八个电容器)。例如,可以让开关包括在电路中并与电容器相联系,以便有选择地包括或从电路中排除多个电容器的任何一个。术语“电容器”指的是配置成存储电荷的任何器件。在一些情况下,外部单元和植入单元的电路可以包含可通过,例如,处理器选择的多个电容器(例如,四个电容器、六个电容器、或十个电容器)。在其它情况下,外部单元110和植入单元120的电路可以包括具有可调电容值的至少一个微调电容器,或至少一个频率相关电容器。在这样的实施例中,该微调电容器可以用于提供多个不同电容值。该多个电容值可以是离散的。可替代地或另外,该电容值可以在一个连续范围上变化,并且可以选在该范围内的任何值上。
如图3所示,外部单元120和植入单元110两者都可以包括天线。外部单元的天线(例如,初级天线150)和植入单元的天线(例如,次级天线152)可以包括配置成传送,发送,发射,和/或接收电磁信号的任何导电结构。该天线可以具有任何适当尺寸、形状、和/或配置。在一些实施例中,天线的数据、它们的尺寸、形状、和/或配置可以通过患者的大小、植入单元的放置地点、植入单元的尺寸和/或形状、调节神经所需的能量的数量、要调节的神经的地点、存在于植入单元上的接收电子器件的类型等来确定。示范性天线可以包括,但不限于,长导线天线、贴片天线、螺旋天线、线圈天线、慢波天线、单极天线、偶极天线、螺旋形、椭圆形、长方形、蜘蛛网等。
在一些实施例中,可植入单元(例如,植入单元110)可以包括安装在柔性载体161上或与其合并的天线(例如,次级天线152)。可以将该天线安排在载体上,配置成从对象的身体外部的地点无线接收能量并将至少一部分能量提供给可植入电路。例如,次级天线152可以包括具有圆形(也参见图4和图5)或椭圆形的线圈天线。这样的线圈天线可以包括导电线圈的任何适当安排(例如,直径、线圈的数量、线圈的布局等)。适合用作次级天线152的线圈天线可以具有在大约5mm与30mm之间的直径,以及可以做成圆形的或椭圆形的。适合用作次级天线152的线圈天线可以具有任何匝数,例如,4,15,20,30,或50。适合用作次级天线152的线圈天线可以具有在大约0.001mm与1mm之间的导线直径。这些天线参数只是示范性的,可以在为获得适当结果而给出的范围上下调整。
可植入单元(例如,植入单元110)另外可以包括从可植入电路接收能量、与载体相联系的至少一个组件。在一些实施例中,该至少一个组件可以包括一对调节电极(例如,植入电极158a和158b)。在植入单元上,该调节电极可以包括任何适当形状和/或取向,只要该电极可以在患者的身体中产生电场就行。植入电极158a和158b还可以包括任何适当导电材料(例如,铜、银、金、铂、铱、铂-铱、铂-金、导电聚合物等)或导电(和/或贵金属)材料的组合物。在一些实施例中,例如,该电极可以包括短线电极、圆形电极、和/或圆形电极对。如图4所示,电极158a和158b可以处在细长臂162的第一延伸部分162a的一端上。但是,该电极可以处在植入单元110的任何部分上。另外,如,例如,图5所例示,植入单元110可以包括处在多个地点上,例如,在细长臂162的第一延伸部分162a和第二延伸部分162b两者的一端上的电极。植入电极可以具有在大约200纳米与1毫米之间的厚度。阳极和阴极电极对可以相隔大约0.2mm到25mm的距离。在另外的实施例中,阳极和阴极电极对可以相隔大约1mm到10mm,或在4mm与7mm之间的距离。相邻阳极或相邻阴极可以相隔小至0.001或更小,或大至25mm或更大的距离。在一些实施例中,相邻阳极或相邻阴极可以相隔在大约0.2mm与1mm之间的距离。
在其它实施例中,至少一个组件包括“电灯”。术语“电灯”指的是配置成产生电磁辐射的任何器件,例如,红外辐射、可见光辐射等。该电灯可以将发光二极管(LED)作为光刺激的可植入源用于基因治疗。
图4提供了植入单元110的示范性配置的示意性表示。如图4所例示,在一个实施例中,场生成电极158a和158b可以包括配备在柔性载体161上的两组各四个圆形电极,一组电极提供阳极,另一组电极提供阴极。植入单元110可以包括一个或多个结构元件,以有助于将植入单元110植入患者的身体中。这样的元件可以包括,例如,有助于在患者的身体内沿着所希望取向对准植入单元110和提供在身体内固定植入单元110的附着点的细长臂、缝合孔、聚合物外科网状物、生物胶、伸出来锚在组织上的柔性载体的尖状物、用于相同目的的另外生物相容材料的尖状物等。例如,在一些实施例中,植入单元110可以包括具有第一延伸部分162a和,可选地,第二延伸部分162b的细长臂162。延伸部分162a和162b可以帮助植入单元110相对于特定肌肉(例如,颏舌肌)、对象的身体内的神经、或身体内神经上面的表面的取向。例如,第一和第二延伸部分162a,162b可以配置成使植入单元能够至少部分围绕患者皮肤下面的软或硬组织(例如,神经、骨骼、或肌肉等)地共形。进一步,植入单元110还可以包括处在柔性载体161上的任何地方上的一个或多个缝合孔160。例如,在一些实施例中,缝合孔160可以处在细长臂162的第二延伸部分162b上和/或在细长臂162的第一延伸部分162a上。植入单元110可以以各种形状构成。另外,或可替代地,植入单元110可以包括下面参照图10更详细描述的外科网状物或其它多孔材料。在一些实施例中,植入单元110可以大致上表现为如图4所例示。在其它实施例中,植入单元110可能缺乏像第二延伸部分162b那样例示的结构,或可能具有沿着不同取向的另外或不同结构。另外,作为显示在图4中的展翅形状的替代品,植入单元110可以大致三角形、圆形、或长方形地形成。在一些实施例中,植入单元110的形状(例如,如图4所示)可以有助于植入单元110相对于要调节的特定神经的取向。因此,可以采用其它规则或不规则形状,以便有助于植入身体的不同部分中。
如图4所例示,可以将次级天线152和天线158a,158b安装在柔性载体161上或与其合并。可以使用各种电路组件和连接导线(下面进一步讨论)将次级天线与植入电极158a和158b连接。为了防止天线、电极、电路组件、和连接导线受对象的身体内的环境影响,植入单元110可以包括封装植入单元110的保护外套。在一些实施例中,该保护外套可以由柔性材料制成,以便能够沿着柔性载体161弯曲。保护外套的封装材料还可以阻止湿气渗入和防止腐蚀。在一些实施例中,该保护外套可以包括多个层,在不同层中包括不同材料或材料的组合。
图5是按照本公开的一个示范性实施例的植入单元110的一个可替代实施例的透视图。如图5所例示,植入单元110可以包括处在,例如,第一延伸部分162a和第二延伸部分162b上的多个电极。图5例示了植入电极158a和158b包括短线电极的实施例。
如上所述,图3是示范性设备(例如,外部单元120)和示范性可植入单元(例如,植入单元110)的示意性表示。在一个实施例中,外部单元120可以包含初级天线(例如,初级天线150)、电路(例如,例示在图6中的电路170)、和至少一个处理器(例如,处理器144)。该至少一个处理器可以初级天线和与植入单元相联系的天线(例如,次级天线152)之间的共振频率失配。该至少一个处理器还可以使初级天线的共振频率发生变化,以便减小共振频率失配。
在一些实施例中,外部单元的天线(例如,初级天线150)可以是具有在大约1cm(厘米)与10cm之间的直径的线圈天线,或可以是圆形的或椭圆形的。例如,初级天线150可以是具有在5cm与7cm之间的直径、和任何匝数,例如,4,8,12,或更多匝的线圈天线。适合用作天线150的线圈天线可以具有在大约0.01mm与2mm之间的导线直径。这些天线参数只是示范性的,可以在为获得适当结果而给出的范围上下调整。初级天线150可以被配置成外部单元120的一部分,或可以直接或间接与外部单元120中的各种组件耦合。例如,如图3所示,初级天线150可以含有与放大器146的电连接件。
在一些实施例中,外部单元可以包括与初级天线电连接的电路。该电路可以包括处理器144、电源140、信号源142、放大器146、至少一个电容器141、和反馈电路148。外部单元的电路可以包括其它电组件,例如,开关、换能器、传感器、检测器、天线、二极管等。例如,外部单元可以包括与例示在图8中的电路元件类似的电路170。
在一些实施例中,外部单元可以包含至少一个处理器144。在一些实施例中,处理器144可以处在外部单元120的外壳内。在可替代实施例中,该至少一个处理器可以被配置成从远离外壳的地点与外部设备有线或无线通信。如本文所使用的术语“处理器”指的是包括按照具体应用的要求配置的任何适当逻辑或计算组件的器件。在一些实施例中,该处理器可以包括含有对一个或多个输入进行逻辑运算的电路的任何物理器件。例如,处理器144可以包括一个或多个集成电路、微芯片、微控制器、微处理器、整个或部分中央处理单元(CPU)、图形处理单元(GPU)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、或适合执行指令或进行逻辑运算的其它电路。控制器执行的指令可以,例如,预装到与控制器合并或嵌入控制器中的存储单元中,或可以存储在像随机访问存储器(RAM)、只读存储器(ROM)、硬盘、光盘、磁介质、闪速存储器、其它永久、固定、或易失性存储器、或能够为控制器存储指令的任何其它机构那样的分立存储单元中。在应用不止一个控制器或处理器的情况下,所有控制器或处理器可以具有类似构造,或它们可以具有相互电连接或断开的不同构造。它们可以是分立电路或集成在单个电路中。当使用不止一个控制器或处理器,它们可以独立地或协作地操作。它们可以电,磁,光,声学,机械地,或通过允许它们交互的其它手段耦合。在一些实施例中,该至少一个处理器可以与存储器相联系。
在例示在图3中的一些其它实施例中,外部单元120可以包括电源140。电源140可以永久地或可移除地与外部单元120内的一个地点耦合。该电源可以进一步包括配置成与处理器电连通的任何适当电源。例如,电源140可以包括像纸质电池、薄膜电池、或其它类型的电池那样的电池。在一些实施例中,电源140可以包括基本平坦的柔性电池。
该电源可以对外部单元内的各种组件供电。例如,电源140可以向处理器144和信号源142提供电力。信号源142可以与处理器144通信,可以包括配置成生成信号(例如,正弦信号、方波、三角形波、微波、射频(RF)信号、或任何其它类型的电磁信号)的任何器件。信号源142可以包括,但不限于,可以生成交流(AC)信号和/或直流(DC)信号的波形发生器。在一个实施例中,信号源142可以生成发送给一个或多个其它组件的AC信号。信号源142可以生成任何适当频率的信号。在一些实施例中,信号源142可以生成具有从大约6.5MHz到大约13.6MHz的频率的信号。在另外的实施例中,信号源142可以生成具有从大约7.4MHz到大约8.8MHz的频率的信号。在进一步的实施例中,信号源142可以生成具有低至90kHz或高至28MHz的频率的信号。
信号源142可以直接或间接与放大器146电连接。该放大器可以包括配置成放大从信号源142生成的一个或多个信号的任何适当器件。放大器146可以包括多种类型放大器件的一种或多种,包括,例如,基于晶体管的器件、运算放大器、RF放大器、功率放大器、或可以提高与信号的一个或多个方面相联系的增益的任何其它类型器件。该放大器可以进一步将放大信号输出到外部单元120内的一个或多个组件。
信号源142还可以直接或间接与至少一个电容器141电连接。至少一个电容器141可以包括配置成存储电荷的任何适当器件。在一些实施例中,外部单元120可以包括相联系的单个电容器,这个电容器可以与处理器相联系。处理器144可能能够选择电容器提供的电容的至少两个不同值。例如,可以将处理器配置成将电容应用于与外部单元中的初级天线相联系的电路。以这种方式改变电容可以改变与外部单元的初级天线相联系的共振频率。该电容器可以是具有固定电容的电容器。在一些实施例中,该电容器可以是可微调的,以便可以由单个电容器提供多个电容值。
在其它实施例中,外部单元120可以包括可以有选择地包括或从与初级天线相联系的电路中排除的多个电容器。例如,外部单元120可以包括电容器(例如,4,6,或更多个)的阵列。处理器144可以被配置成有选择包括或从与初级天线相联系的电路中排除多个电容器的任何一个,以便改变与初级天线相联系的共振频率。在一个例子中,六个电容器的阵列可以允许处理器从64(即,26)个不同可能值中选择一个电容值。
图10A和10B例示了按照一些实施例的外部单元的例子。该例子例示了可以在其它实施例中的任何组合中找到的特征。图10A例示了描绘载体1201和电子器件外壳1202的外部单元120的侧视图。
载体1201可以包括配置成,例如,通过机械部件的粘合剂粘附在对象的皮肤上的皮肤贴片。载体120可以是柔性的或刚性的,或可以具有柔性部分和刚性部分。载体1201可以包括配置成有选择地或可移除地将载体1201与电子器件外壳1202连接的连接器1203。连接器1203可以从载体1201延伸或突出来。连接器1203可以被电子器件外壳1202的凹部1204接纳。连接器1203可以被配置成不实质性使用凹入特征件地提供与电子器件外壳1204的有选择连接的连接器。连接器1203可以包括,例如,桩状物、或从载体1201延伸出来的另一种连接元件。连接器1203可以进一步包括磁连接件、尼龙搭扣连接件、和/或金属弹片连接件。连接器1203还可以包括配置成相对于载体120将电子器件外壳1202定位在特定高度、轴向地点、和/或沿轴取向上的定位特征件。连接器1203的定位特征件可以进一步包括桩状物、环状物、盒状物、椭圆物、***物等。连接器1203可以在载体1201的中心上,可以偏移中心预定数量,或可以配备在载体1201的任何其它适当地点上。可以在载体1201上配备多个连接器1203。连接器1203可以被配置成从电子器件外壳1202上移除可以使连接器折断。这样的特征可能是防止载体重新使用所希望的,载体1201被连续使用可能会丧失一些功效。
在一些实施例中,外部单元可以包括外壳。该外壳可以包括配置成保留组件的任何适当容器。虽然在图10A和10B中只示意性例示了外壳的一个实施例,但外壳的其它实施例可以包括任何适当尺寸和/或形状,并且可以是刚性的或柔性的。外部单元120可以包括贴片、按钮、由任何适当材料构成的具有可变形状和尺度的其它接受器的一种或多种。在一个实施例中,外部单元120可以包括使外部单元能够与所希望地点共形的柔性材料。例如,如图2所例示,外部单元可以包括皮肤贴片,该皮肤贴片又可以包括柔性基底。柔性基底的材料可以包括,但不限于,塑料、硅胶、编织的天然纤维、和其它适当聚合物、共聚物、和它们的组合体。取决于特定应用的要求,外部单元120的任何部分都可以是柔性的或刚性的。
电子器件外壳1202可以包括电子器件部分1205,电子器件部分1205可以以合适的任何方式安排在电子器件外壳1202内。电子器件部分1205可以包括外部单元120的下面进一步讨论的各种组件。例如,电子器件部分1205可以包括与外部单元120相联系的至少一个处理器144、像电池那样的电源140、初级天线152、和电路170的任何组合。电子器件部分1205还可以包括如与外部单元120相联系的本文所述的任何其它组件。本领域的普通技术人员也可以认可另外的组件。
电子器件外壳1202可以包括配置成接纳连接器1203的凹部1204。电子器件外壳1202可以包括至少一个电连接器1210,1211,1212。电连接器1210,1211,1212可以被安排成如图10B所示,带有数对电触点,或带有任何其它数量的电触点。每个电连接器1210,1211,1212的电触点对可以在外壳1202的内部相互连续电连接,以便电触点对代表与电路的单连接点。在这样的配置中,唯一必要的是连接一对内的电触点之一。电连接器1210,1211,1212可以包括冗余电触点。每个电连接器1210,1211,1212的电触点也可以代表电路的相对端,例如,电池充电电路的正负端。
返回到图3,外部单元120可以与植入单元110通信。例如,在一些实施例中,可以使用处理器144、信号源142、和放大器146在初级天线150上生成初级信号。更具体地说,在一个实施例中,电源140可以向处理器144和信号源142之一或两者供电。处理器144可以使信号源1422生成信号(例如,RF能量信号)。信号源142可以将生成的信号输出到放大器146,放大器146可以放大信号源142生成的信号。放大的数量,因此,信号的振幅可以,例如,通过处理器144来控制。处理器144使放大器146应用于信号的增益或放大的数量可以取决于多种因素,包括,但不限于,初级天线150的形状、尺寸、和/或配置、患者的大小、患者中植入单元110的地点、次级天线152的形状、尺寸、和/或配置、初级天线150与次级天线152之间的耦合度(下面进一步讨论)、和植入电极158a,158b要生成的电场的所希望幅度等。放大器146可以将放大的信号输出到初级天线150。
在一些实施例中,外部单元120可以将来自初级天线150的初级信号传送(例如,发送)给植入单元110的次级天线152。这种传送可以由初级天线150与次级天线152之间的耦合引起。初级天线和次级天线这样的耦合可以包括响应应用于初级天线的信号,在次级天线上引起信号的初级天线和次级天线之间的任何相互作用。初级和次级天线之间的耦合可以包括电容耦合、电感耦合、射频耦合和它们的任何组合。
初级天线150和次级天线152之间的耦合可以取决于初级天线相对于次级天线的接近度。也就是说,在一些实施例中,初级天线150和次级天线152之间的耦合的效率或程度可以取决于初级天线与次级天线的接近度。初级和次级天线的接近度可以用同轴偏移(例如,当初级和次级天线的中心轴共同对准时,初级和次级天线之间的距离)、横向偏移(例如,初级天线的中心轴与次级天线的中心轴之间的距离)、和/或角偏移(例如,初级和次级天线的中心轴之间的角差)的术语来表达。在一些实施例中,当同轴偏移、横向偏移、和角偏移都是零时,在初级天线150和次级天线152之间可能存在理论最大效率。增大同轴偏移、横向偏移、和角偏移的任何一个可以具有降低初级天线150和次级天线152之间的耦合的效率或程度。
作为初级天线150和次级天线152之间的耦合的结果,当在初级天线150上存在初级信号时,可以在次级天线152上引起次级信号。这样的耦合可以包括电感/磁耦合、RF耦合/发射、电容耦合、或可以响应在初级天线150上生成的初级信号,在次级天线152上生成次级信号的任何其它机制。耦合可以指初级和次级天线之间的任何相互作用。除了初级天线150和次级天线152之间的耦合之外,与植入单元110相联系的电路组件也可能影响次级天线152上的次级信号。因此,次级天线152上的次级信号可以指与源无关出现在次级天线152上的任何和所有信号和信号成分。
虽然在初级天线150上存在初级信号可以在次级天线152上引起或感应次级信号,但作为在次级天线152上出现次级信号的结果,两个天线之间的耦合也可以导致初级天线150上的耦合信号或信号成分。由次级天线152上的次级信号感应的初级天线150上的信号可以称为初级耦合信号。初级信号可以指与源无关,出现在初级天线150上的任何和所有信号或信号成分,初级耦合信号可以指作为与出现在次级天线152上的信号耦合的结果,在初级天线上引起的任何信号或信号成分。因此,在一些实施例中,初级耦合信号可能对初级天线150上的初级信号有贡献。
植入单元110可以响应外部单元120。例如,在一些实施例中,在初级线圈150上生成的初级信号可以在次级天线152上引起次级信号,该次级信号又可能通过植入单元110引起一个或多个响应。在一些实施例中,植入单元110的响应可以包括在植入电极158a和158b之间生成电场。在其它实施例中,植入单元110的响应可以包括对植入电灯供电。
图6例示了可以包括在外部单元120中的电路(170)和包括在植入单元110中的电路(180)。在电路170和电路180之一或两者中可以包括另外的、不同的、或较少的电路组件。如图6所示,初级天线152可以含有与植入电极158a,158b的电连接件。在一些实施例中,将初级天线152与植入电极158a,158b连接的电路在次级天线152上存在次级信号的情况下可能引起跨过植入电极158a和158b的电压。这种电压可以称为场感应信号,因为这种电压可以在植入电极158a和158b之间生成电场。更广义地说,场感应信号可以包括可以导致在电极之间生成电场、应用于与植入单元相联系的电极的任何信号(例如,电压)。
初级天线150和次级天线152之间能量传送的效率可能取决于包括,例如,与初级天线150(以及它的相关电路170)相联系的共振频率如何接近地与次级天线152(以及它的相关电路180)相联系的共振频率匹配的因素。共振频率包括使电路自然振荡的频率。在一些情况下,植入单元(例如,包括天线152)的共振频率可能与外部单元(例如,包括初级天线150)的共振频率匹配或基本相等。这些情况可以指在植入单元和外部单元之间共振频率匹配的那些情况。在其它情况下,植入单元的共振频率可能不同于外部单元的共振频率。这些情况可以指在植入单元和外部单元之间共振频率失配的那些情况。
例如,植入单元和外部单元之间的频率匹配度可以通过两个共振频率的相互接近度来表征。例如,当两个共振频率之间的差值不大于,例如,外部单元的共振频率的30%,20%,10%,5%,1%,0.5%,0.1%或更小值时,可以认为出现了共振频率匹配。于是,当两个共振频率不匹配时,可以认为出现了也简称为“频率失配”的共振频率失配。例如,当两个共振频率(例如,植入单元和外部单元的共振频率)之间的差值相对于共振频率之一(例如,外部单元的共振频率)大于大约30%,40%,50%,60%或更大值时,可以认为出现了共振频率失配。在其它实施例中,当两个共振频率之间的差值不大于频率之一的大约0.5%时,可以认为出现了共振频率匹配。两个共振频率的接近度可能影响两个天线之间的能量传送。例如,两个天线之间能量传送的效率可能取决于几种因素,其中之一可能是天线的共振频率匹配的程度。因此,如果所有其它因素保持不变,则改变一个天线相对于另一个天线的共振频率将改变能量传送的效率。当能量传送的效率至少50%时,可以认为出现了两个天线之间的共振频率匹配。在一些实施例中,可以将共振频率匹配与60%,70%,80%,90%,95%或更大值的能量传送效率相联系。
本公开包括改变或要不然控制外部单元和植入单元之间的共振频率匹配或失配的水平的手段。例如,当将植入单元放置在身体中时,环境的改变(例如,身体中的湿度等)可以引起植入单元(包括,例如,植入单元的可植入电路和次级天线)的共振频率漂移。这种漂移可能导致植入单元和外部单元的共振频率之间的失配,尤其在植入单元的共振频率和外部单元的共振频率在将植入单元植入身体中之前匹配的情况下。因此,解决可能在植入单元和外部单元之间引起的频率失配的一种手段可以包括预测将植入单元植入身体中引起的漂移量。例如,如果漂移量是已知的,可以估计的,计算的,测量的等,则可以在植入之前,制造,调整,调谐等植入单元中的电路,以便考虑到预期漂移。
在一些情况下,内部共振频率的漂移在植入之后,在达到稳定之前可能持续几天到几个月。例如,植入单元的共振频率可能从8.0kHz漂移到7.9kHz。在一些实施例中,可以使用实验或模拟预测共振频率可能会漂移多少。因此,在上面的例子中,如果7.9kHz的长期共振频率值是所希望的,则可以将植入单元制造成在植入之前具有8.1kHz的共振频率值。
按照一些实施例,内部共振频率(例如,与可植入电路和次级天线相联系的共振频率)可能取决于与可植入电路相联系的电容。因此,在一些实施例中为了设置特定共振频率,可以通过在封装之前加入和/或调整一个或多个微调电容器调整植入单元的可植入电路的电容。调整量可能取决于将植入单元放置在身体中之后共振频率漂移的预期量。
当已知预期共振频率漂移时,例如,可以通过调整与可植入电路相联系的电容设置植入单元的共振频率。在一个实施例中,可以在***植入电路中之前将与可植入电路相联系的电容器调整(例如,激光微调)成特定电容值。在另一个实施例中,可以将已知数值的电容器***植入电路中。在又一个实施例中,可以将多个电容器***植入电路中,以便设置可植入电路的电容和调整植入单元的共振频率。这样的多个电容器可以包括每一个具有可能相同或不同的至少一个电容值的一系列电容器。可以根据特定电容值计算共振频率。可替代地,可以在电容调整之后迭代地确定共振频率值。例如,在电容调整之后,可以测量所得共振频率。如果共振频率具有所希望值,则可能不必作进一步调整。否则,可以迭代地继续执行调整和测量的过程,直到获得所希望或目标共振频率。
在一些实施例中,如上所讨论,可以确定与可植入电路相联系的电容,以便在植入单元被放置在身体中之后和在共振频率漂移的预期水平之后,可以使可植入电路的内部共振频率和外部单元的外部共振频率共振频率匹配。漂移的预期水平可以通过计算来确定。可替代地或另外,漂移的预期水平可以通过测试来确定。
一些实施例可以包括制造植入单元的方法。例如,可以将可植入电路安排在载体上,以及可以将天线安排在载体上。该天线可以包括配置成从外部单元无线接收能量并将至少一部分接收能量传送给可植入电路的天线。该方法还可以包括为植入单元确定共振频率漂移的预期水平,并调整与可植入电路相联系的电容,以便包括次级天线和可植入电路的植入单元包括目标共振频率。目标共振频率与外部单元(例如,包括初级天线和相关电路)的共振频率之间的差值可能与植入单元在植入身体中之后经历的预期共振频率漂移的数量接近,基本相等,或相等。
在一些情况下,外部单元的共振频率在使用期间可能发生变化。例如,当初级天线152被弯曲成与对象的皮肤共形时,初级天线152内的空间关系线圈可能漂移,引起共振频率变化。另外,与存在于皮肤上的湿气或其它作用剂的接触也可能引起共振频率变化。于是,减小植入单元和外部单元之间的共振频率失配的另一种手段可能把重点放在调整与外部单元相联系的共振频率上。例如,可以将与外部单元相联系的处理器配置成确定初级天线和与植入单元相联系的次级天线之间的当前共振频率失配。作出响应,处理器可以提供对外部单元的电路的至少一个组件的调整,以便使外部单元的共振频率发生变化。例如,在一些实施例中,处理器可以将多个不同电容应用于外部单元的电路,这可以对应于电路的多个不同共振频率。对于不同共振频率的至少一些,处理器可以确定外部单元和植入单元之间的多个能量传输效率值。根据确定的能量效率值,处理器可以选择提供在预定阈值之上的效率或与目标效率最接近的效率等的特定电容值。
在一些实施例中,处理器可以根据初级信号从初级天线到次级天线的传输确定共振频率失配。该确定可以基于初级耦合信号和初级天线与次级天线之间的耦合。通过监视初级耦合信号,处理器可以确定又可能是共振频率失配的传输效率。
可以将处理器配置成根据任何适当条件确定共振频率失配的水平。例如,当处理器确定能量传送效率下降到某个阈值(例如,70%)以下时,可以确定失配的数量,以及可以调整与外部单元相联系的电路,以便减小或消除失配。可替代地或另外,处理器可以周期性地监视共振频率失配的当前水平(例如,每隔几秒,分钟,小时,天等)。在一些实施例中,处理器可以以不等时间间隔监视共振频率失配的当前水平。例如,可以将处理器配置成在新植入植入单元之后(例如,在植入之后的第一个星期或月期间)以较短时间间隔监视植入单元与外部单元之间的共振频率失配的水平。随着植入时间变长,植入单元的共振频率的漂移可能达到稳定。因此,随着植入时间变长,处理器可以较不频繁地监视共振频率失配。
一旦确定了植入单元与外部单元之间的共振频率失配,处理器可以调整外部单元中的电路(例如,包括初级天线的自共振发送器电路)的共振频率,以便减小失配。自共振发送器电路可以包括允许调整电路的共振频率的特征。这样的调整可以通过有选择地使至少一个电容器包括在自共振发送器电路中和从自共振发送器电路中排除至少一个电容器来进行。将电容器加入自共振发送器电路中(或从中减去)可以引起电路的共振频率变化。在一些实施例中,与初级天线相联系的共振频率的变化可以使初级天线的共振频率和次级天线的共振频率基本匹配。
在一个实施例中,外部单元包括配置成有选择地包括和从电路中有选择地排除的至少一个电容器。处理器可以通过有选择地包括和从电路中排除至少一个电容器调整初级天线的共振频率。例如,外部单元的电路可以配有通过处理器控制开关,配置成有选择包括和排除的一个或多个电容器或微调电容器。该开关可以包括,例如,晶体管或继电器。因此,处理器可以通过打开或闭合与各个电容器相联系的开关包括或从电路中排除电容器。
与开关或处理器可选电容值相联系的单个电容器可以使处理器能够在共振频率的至少两个不同值之间作出选择。在一个实施例中,外部单元可以包括多个电容器(例如,4,6,12或更多个)的阵列,使处理器能够选择基于电容器的组合的电容。例如,六个电容器的阵列将产生64种不同电容组合,以及在理论上,相似数量的共振频率值。在一些实施例中,可以将处理器配置成将多于或少于所有可用电容器的电容器用于调整电路或用于测试共振频率失配等。在一些实施例中,包括在可用于处理器的多个电容器中的电容器的每一个可以包括相同电容值或可以包括各种不同数值。
至少一个处理器可以有选择地包括或排除来自一个或多个可微调电容器或来自多个电容器的一个或多个的电容值,以便确定植入单元与外部单元之间的频率失配的当前水平。根据失配的当前水平,处理器然后可以尝试通过有选择地包括或排除来自一个或多个可微调电容器或来自多个电容器的一个或多个的电容值,以便将外部单元的共振频率设置在所希望共振频率值上或附近来减小,最小化,或消除失配的当前水平。这样,处理器可以尝试减小,最小化,或消除被确定为存在于外部单元与植入单元之间的任何失配。
按照一个实施例,处理器可以从多个电容器当中选择电容器的组合,以便提供超过预定阈值的共振频率匹配。例如,电容值的选择可能导致植入单元的共振频率与外部单元的共振频率之间的差值不大于外部单元的共振频率的10%。
在一些实施例中,外部单元的处理器可以将调整应用于电路的至少一个组件,引起外部单元的共振频率变化。在一个示范性实施例中,该调整包括将电容器阵列当中的电容器切换到电路中和从电路中切换出来。例如,在发送初级信号期间,处理器可以确定改变(例如,提高)传输效率和共振频率匹配的电容器组合。该调整可以使初级天线的共振频率与初级天线的共振频率之间的差值不大于,例如,初级天线的共振频率的30%。另外,该调整可以在外部单元与植入单元之间实现至少50%的能量传送效率。
图11描绘了用在共振频率匹配方法上的应用改进D类放大器的自共振发送器电路的另外实施例。取代描绘在图3中的外部单元120的任何或所有元件,或除此之外,可以使用改进D类放大器1600。例如,改进D类放大器1600可以取代信号源142和放大器146。在这个实施例中,处理器144可以调整D类放大器的操作,以便提供生成信号与初级天线150的共振频率之间的频率匹配。因为在操作期间可以将初级天线150的共振频率调整成与次级天线152的共振频率匹配,所以也调整生成信号的频率以便提高外部单元120的共振发送器电路内的效率可能是有利的。改进D类放大器1600可以用于提供像如下那样的调整。改进D类放大器1600包括其包括开关(像MOSFET)1620的H桥1601。在开关之间的是自共振发送器电路1610。改进D类放大器1600的电力通过供应电压1650供应,供应电压1650可以从,例如,电池供应。如图16所示,自共振发送器电路1610可以包括多个电容1640和多个电感1660。电容1640可以包括可以从如上所述的电容器当中选择其组合,以便有选择地提供电容1640的适当数值的多个电容器。电容1640的数值可以针对与次级天线152的共振频率匹配来选择。电感1660至少部分可以由初级天线150提供。处理器144还可以调整H桥开关1620的驱动频率,以便生成频率与自共振电路1610匹配的信号。通过有选择地适当打开和闭合开关1620,可以将供应电压1650的DC信号转换成所选频率的方波。可以将这个频率选成与自共振电路1610的共振频率匹配,以便提高电路的效率。
图12描绘了例示用在共振频率匹配方法上的脉冲模式自共振发送器1700的另外实施例。取代描绘在图3中的外部单元120的任何或所有元件,或除此之外,可以使用脉冲模式自共振发送器1700。例如,脉冲模式自共振发送器1700可以取代信号源142和放大器146。在这个实施例中,处理器144可以通过在本实施例中描绘成开关1730的电力开关单元控制电路。电力开关单元可以包括晶体管、继电器、或类似开关器件。脉冲模式自共振发送器1700包括初级电源1780,例如,电池或交流电源。发送器1700可以包括像存储电容器1750那样的电力存储单元。也可以利用像电感器和/或电池那样的其它适当电力存储单元,以及这些存储单元的组合体。发送器1700还可以包括自共振发送器电路1710,其包括共振电容1720和共振电感1760。共振电感1760至少部分可以由初级天线150提供。
除了别的以外,发送器1700可以以如下方式操作。处理器144可以控制开关1730的操作。当开关1730保持在打开位置上,来自电源1780的电流流入存储电容器1750中,存储电容器1750从而累积电荷。当将开关1730闭合时,充电的存储电容器1750在电流装载时段期间将电流驱动到自共振电路1710中,将能量存储在电感1760中。由于二极管1770的操作,流入电路1710中的电流在能量累积的时段之后被切断。传送给电路1710的电流然后以电路1710的共振频率在电路1710内自由振荡,因此生成通过初级天线150(包括在电路中,至少形成电感1760的一部分)发送给植入单元的信号。因为信号是通过电路1710的自共振生成的,所以它与电路1710的共振频率匹配,并且可以进行更有效发送。
可以将发送器1700的组件选择成使电流装载时段是近似2微秒,以及电路1710中的自由振荡的时段在10和20微秒之间。但是,也可以将其它组件选择成提供任何所希望电流装载时段或自由振荡时段。如本公开中的其它地方所述,可能希望可变长度的刺激脉冲。比自由振荡的单个时段长的刺激脉冲可以由将来自存储电容器1750的能量装载和释放到电路1710中的多次循环构成。存储电容器1750本身可以被选成存储足够的电荷来驱动大量振荡循环(例如,在10与100之间),以便无需从电源1780再充电地构建整个刺激脉冲。
脉冲模式自共振发送器1700可以提供几个优点。如上所述,因为发送信号通过电路1710的自共振生成,所以有可能与电路1710的共振频率匹配,避免了将生成信号的频率与电路共振频率匹配的需要。进一步,因为在对电路1710再充电之前将能量存储在电容器1750中,所以可以提供选择电源1780的更大灵活性。有效神经刺激可能取决于迅速增大的电流水平。只利用电池达到这个目的可能需要高压和/或大电流电池。这种需要可以通过允许通过使用相应低压/小电流电池传输极高峰值电流的发送器1700来避免。发送器1700使用比传统放大电路少的开关(例如,晶体管)。每个开关都可能是成为总体低效电路的原因之一的能量损失源。在发送器1700中存在单个开关1730可以总体提高电路的效率。
作为通过电路180限制次级信号的结果,可以生成场感应信号。如图6所示,外部单元120的电路170可以在初级天线150上生成可以在次级天线152上引起AC次级信号的AC初级信号。但是,在某些实施例中,在植入电极158a和158b上提供DC场感应信号可能是有利的(例如,以便生成调节神经的单向电场)。为了将次级天线152上的AC次级信号转换成DC场感应信号,植入单元110中的电路180可以包括AC-DC转换器。该AC到DC转换器可以包括本领域的普通技术人员已知的任何适当转换器。例如,在一些实施例中,该AC到DC转换器可以包括整流电路组件,其包括,例如,二极管156和适当电容器和电感器。在可替代实施例中,植入单元110可以包括AC-AC转换器,或不包括转换器,以便在植入电极158a和158b上提供AC场感应信号。
如上所述,该场感应信号可以生成植入电极158a和158b之间的电场。在一些情况下,由该场感应信号引起的所生成电场的幅度和/或持续时间可以足以调节电极158a和158b附近中的一种或多种神经。在这样的情况下,该场感应信号可以称为调节信号。在其它情况下,该场感应信号的幅度和/或持续时间可以生成不导致神经调节的电场。在这样的情况下,该场感应信号可以称为欠调节信号。
各种类型的场感应信号都可以构成调节信号。例如,在一些实施例中,调节信号可以包括适中振幅和适中持续时间,而在其它实施例中,调节信号可以包括较高振幅和较高持续时间。跨过电极158a,158b的场感应信号的各种振幅和/或持续时间都可能得出调节信号,场感应信号是否升高到调节信号的水平可以取决于许多因素(例如,相对于要刺激的特定神经的距离;神经是否是分叉的;感应电场相对于神经的取向;存在于电极与神经之间的组织的类型等)。
场感应信号构成调节信号(导致可以引起神经调节的电场)还是欠调节信号(导致无意引起神经调节的信号)最终可以通过外部单元120的处理器144来控制。例如,在某些状况下,处理器144可以确定神经调节是合适的。在这些状况下,处理器144可以使信号源144和放大器146在初级天线150上生成调节控制信号(即,具有所选的幅度和/或持续时间,以便次级天线152上的所得次级信号将在植入电极158a和158b上提供调节信号的信号)。
处理器144可以限制从外部单元120传送到植入单元110的能量的数量。例如,在一些实施例中,可以将植入单元110与可以考虑到与患者和/或植入相联系的众多因素的能限阈值相联系。例如,在一些情况下,患者的某些神经应该接收不大于预定最大数量的能量,以便使损害神经和/或周围组织的风险最小化。另外,植入单元110的电路180可以包括具有可能影响植入单元110的实际能限阈值的最大工作电压或功率水平的组件。处理器144可以被配置成当设置要应用于初级天线150的初级信号的幅度和/或持续时间时考虑到这样的限制。
除了确定可以传输给植入单元110的功率的上限之外,处理器144还可以至少部分根据传输功率的功效确定功率下阈。该功率下阈可以根据实现神经调节的功率的最小数量(例如,功率水平在功率下阈以上的信号可以构成调节信号,而功率水平在功率下阈以下的信号可以构成欠调节信号)来计算。
功率下阈也可以以可替代方式测量或提供。例如,植入单元110中的适当电路或传感器可以测量功率下阈。功率下阈可以通过另外的外部设备计算或感测,随后被编程到处理器144中,或被编程到植入单元110中。可替代地,植入单元110可以由具体选成在电极上生成至少功率下阈的信号的电路180构成。在又一个实施例中,可以将外部单元120的天线调整成接纳或产生与特定功率下阈相对应的信号。该功率下阈可以因患者而异,以及可以考虑到像,例如,特定患者的神经纤维的调节特性、植入之后植入单元110与外部单元120之间的距离、和植入单元组件(例如,天线和植入电极)的尺寸和配置等那样的众多因素。
处理器144还可以使欠调节控制信号应用于初级天线150。这样的欠调节控制信号可以包括在电极158a,158b上导致欠调节信号的振幅和/或持续时间。虽然这样的欠调节控制信号可能不导致神经调节,但这样的欠调节控制信号可能实现神经调节***的基于反馈控制。也就是说,在一些实施例中,处理器144可以使欠调节控制信号应用于初级天线150。这种信号可以在次级天线152上感应次级信号,这又在初级天线150上感应初级耦合信号。
为了分析在初级天线150上感应的初级耦合信号,外部单元120可以包括反馈电路148(例如,信号分析器或检测器等),该反馈电路148可以放置成直接或间接与初级天线150和处理器144通信。欠调节控制信号可以以任何所希望周期性应用于初级天线150。在一些实施例中,欠调节控制信号可以以每五秒(或更长时间)一次的速率应用于初级天线150。在其它实施例中,可以更频繁地(例如,每两秒一次,每一秒一次,每一毫秒一次,每一纳秒一次、或每秒多次地应用欠调节控制信号。进一步,应当注意到,反馈信号也可以在将调节控制信号应用于初级天线150(即,导致神经调节的那些)的时候接收,因为这样的调节控制信号也可能导致在初级天线150上生成初级耦合信号。
初级耦合信号可以通过反馈电路148反馈到处理器144,并且可以用作确定初级天线150与次级天线152之间的耦合度的基础。该耦合度可以实现两个天线之间的能量传送的功效的确定。处理器144还可以将确定的耦合度用在调控对植入单元110的电力输送中。
处理器144可以配有根据确定的耦合度确定如何调控对植入单元110的电力传送的任何适当逻辑。例如,在初级耦合信号指示耦合度从基准耦合水平开始变化的情况下,处理器144可以确定次级天线152相对于初级天线150发生了移动(以同轴偏移、横向偏移、角偏移、或任何组合)。可以将这样的移动,例如,与植入单元110的移动、和根据其植入地点与之相联系的组织相联系。因此,在这样的状况下,处理器144可以确定对象的身体中的神经的调节是否合适。更具体地说,响应耦合变化的指示,在一些实施例中,处理器144可以使调节控制信号应用于初级天线150,以便在,例如,植入电极158a,158b上生成调节信号,引起对患者神经的调节。
在治疗OSA的实施例中,可以将植入单元110的移动与可能指示睡眠呼吸暂停事件或睡眠呼吸暂停前兆的开始的舌头的移动相联系。睡眠呼吸暂停事件或睡眠呼吸暂停前兆的开始可能要求刺激患者的颏舌肌来解除或避开该事件。这样的刺激可能导致肌肉的收缩和患者的舌头远离患者的气道的移动。
在治疗包括偏头痛的头痛的实施例中,处理器144可以根据来自,例如,用户的信号,或与头痛相联系的感测神经元(例如,较大的枕神经和三叉神经)中神经活动的检测水平生成调节控制信号。由处理器生成并应用于初级天线150的调节控制信号可以在,例如,植入电极158a,158b上生成调节信号,使患者的感觉神经受到抑制或阻止。这样的抑制或阻止可以降低或消除患者对疼痛的感觉。
在治疗高血压的实施例中,处理器144可以根据,例如,预编程指令和/或指示高血压的来自植入单元的信号生成调节控制信号。由处理器生成并应用于初级天线150的调节控制信号可以在,例如,植入电极158a,158b上生成调节信号,取决于要求,使患者的神经受到抑制或刺激。例如,放置在颈动脉或颈部动脉中(即,在颈压力感受器附近)的神经调节器可以接收调适成在电极上感生刺激信号的调节控制信号,从而使与颈压力感受器相联系的舌咽神经以提高的速率发热,以便向大脑发送低血压的信号。可以利用植入患者颈部中或患者耳朵后面的皮下地点中的神经调节器实现舌咽神经的类似调节。放置在肾动脉中的神经调节器可以接收调适成在电极上引起抑制或阻止信号的调节控制信号,从而抑制从肾神经传送到肾脏的使血压升高的信号。
调节控制信号可以包括刺激控制信号,欠调节控制信号可以包括欠刺激控制信号。刺激控制信号可以具有在电极158a,158b上导致刺激信号的任何振幅、脉冲持续时间、或频率组合。在一些实施例中(例如,在大约6.5-13.6MHz之间的频率上),刺激控制信号可以包括大于大约50微秒的脉冲持续时间和/或近似0.5安培,或在0.1安装与1安培之间,或在0.05安装与3安培之间的振幅。欠刺激控制信号可以具有小于大约500纳秒,或小于大约200纳秒的脉冲持续时间和/或小于大约1安装,0.5安培,0.1安培,0.05安培,或0.01安培的振幅。当然,这些数值只意味着提供一般参考,因为高于或低于提供的示范性指导线的数值的各种组合可能导致或可能不导致神经刺激。
在一些实施例中,刺激控制信号可以包括脉冲列,其中每个脉冲都包括多个子脉冲。如下所述,可以使用交流电信号(例如,在大约6.5-13.6MHz之间的频率上)来生成脉冲列。子脉冲可以具有在50-250微秒之间的持续时间,或在1微秒与2毫秒之间的持续时间,在该持续时间期间接通交流电信号。例如,10MHz交流电信号的200微秒子脉冲将包括近似2000个周期。每个脉冲又可以具有在100和500微秒之间的持续时间,在该持续时间期间以50和100Hz之间的频率出现子脉冲。例如,50Hz子脉冲的200毫秒脉冲将包括近似10个子脉冲。最后,在脉冲列中,每个脉冲可以与下一个脉冲分开0.2和2秒之间的持续时间。例如,在每一个与下一个分开1.3秒的200毫秒脉冲的脉冲列中,将每1.5秒出现一个新脉冲。这个实施例的脉冲列可以用于,例如,在治疗会话期间提供持续刺激。在OSA的背景下,治疗会话可以是对象睡着,并且需要治疗以防止OSA的时段。这样的治疗会话可能在某个地方持续大约3到10个小时。在应用本公开的神经调节器的其它状况的背景下,治疗会话按照治疗状况的持续时间,可能具有可变长度。
处理器144可以通过监视经由反馈电路148接收的初级耦合信号的一个或多个方面确定初级天线150与次级天线152之间的耦合度。在一些实施例中,处理器144可以通过监视与初级耦合信号相联系的电压水平、电流水平、或可能取决于初级天线150与次级天线152之间的耦合度的任何其它属性,确定初级天线150与次级天线152之间的耦合度。例如,响应应用于初级天线150的周期性欠调节信号,处理器144可以确定与初级耦合信号相联系的基准电压水平或电流水平。这种基准电压水平,例如,可以与未发生睡眠呼吸暂停事件或它的前兆时,例如,在正常睡眠期间患者舌头的移动范围相联系。随着患者的舌头移向与睡眠呼吸暂停事件或它的前兆相联系的位置,初级天线150与次级天线152之间的同轴,横向,或角偏移可能发生变化。其结果是,初级天线150与次级天线152之间的耦合度可能发生变化,以及初级天线150上的初级耦合信号的电压水平或电流水平也可能发生变化。当与初级耦合信号的电压水平、电流水平、或其它电特性变化了预定数量或达到预定绝对值时,处理器144可以识别睡眠呼吸暂停事件或它的前兆。
图7提供了更详细例示这种原理的曲线图。对于一个线圈接收射频(RF)驱动信号的双线圈***,曲线图200绘制了作为线圈之间的同轴距离的函数的接收线圈中的感生电流的变化率。对于各种线圈直径和初始位移,曲线图200例示了当将线圈移得更接近或更远离时,感生电流对线圈之间的进一步位移的敏感性。还指明了次级线圈中的总感生电流随着次级线圈移离初级驱动线圈而减小,即,以mA/mm为单位的感生电流的变化率始终是负的。感生电流对线圈之间的进一步位移的敏感性随距离而变。例如,在10mm的分开距离上,14mm线圈中作为附加位移的函数的电流的变化率是近似-6mA/mm。如果线圈的位移近似22mm,则响应附加位移,感生电流的变化率是近似-11mA/mm,它对应于感生电流的变化率的局部最大值。将分开距离增大到超过22mm继续导致次级线圈中的感生电流下降,但变化率减小。例如,在大约30mm的分开距离上,10mm线圈响应附加位移,经历了大约-8mA/mm的感生电流的变化率。借助于这种类型的信息,处理器144可能能够在任何给定时间,通过观察与初级天线150上的初级耦合信号相联系的电流的幅度和/或幅度的变化率,确定初级天线150与次级天线152之间的具体耦合度。
处理器144可以通过监视初级耦合信号的其它方面确定初级天线150与次级天线152之间的耦合度。例如,在一些实施例中,可以监视植入单元110中的电路180的非线性行为来确定耦合度。例如,初级天线150上的初级耦合信号的谐波成分的存在、缺乏、幅度、减小和/或开始可能反映电路180响应各种控制信号(例如,欠调节或调节控制信号)的行为,因此,可以用于确定初级天线150与次级天线152之间的耦合度。
如图6所示,植入单元110中的电路180由于,例如,存在像二极管156那样的非线性电路组件而可能构成非线性电路。这样的非线性电路组件在某些操作状况下可能引起非线性电压响应。当二极管156两端的电压超过二极管156的激活阈值时,可能引起非线性操作状况。因此,当以特定频率激发植入电路180时,这种电路可能以多个频率振荡。因此,次级天线152上的次级信号的谱分析可能揭示以激发频率的某些倍数出现、叫做谐波的一种或多种振荡。通过初级天线150与次级天线152之间的耦合,植入电路180产生和出现在次级天线152中的任何谐波也可能出现在存在于初级天线150上的初级耦合信号中。
在某些实施例中,电路180可以包括在某个转变点之上改变在电路180中生成的谐波的特性的附加电路组件。监视这些非线性谐波在转变点之上和之下如何表现可以实现初级天线150与次级天线152之间的耦合度的确定。例如,如图6所示,电路180可以包括谐波修正电路154,其可以包括非线性变更在电路180中生成的谐波的任何电子组件。在一些实施例中,谐波修正电路154可以一对齐纳二极管。在某个电压水平以下,这些齐纳二极管保持正向偏置,以便没有电流流过任何一个二极管。但是,在齐纳二极管的击穿电压之上,这些器件沿着反向偏置方向变成导通的,允许电流流过谐波修正电路154。一旦齐纳二极管变成导通的,它们就开始影响电路180的振荡行为,其结果是,可能影响某些谐波振荡频率(例如,使幅度减小)。
图8和9例示了这种作用。例如,图8例示了在范围从大约10纳安到大约20微安的几个振幅上示出了电路180的振荡行为的曲线图300a。如图所示,初级激发频率出现在大约6.7MHz上,谐波表现在初级激发频率的偶数倍和奇数倍两者上。例如,偶数倍出现在两倍的激发频率(波峰302a)、四倍的激发频率(波峰304a)和六倍的激发频率(波峰306a)上。随着激发信号的振幅在10纳安与40微安之间增大,波峰302a,304a和306a的振幅都增大。
图9例示了谐波修正电路154引起的对电路180的偶数谐波响应的作用。图9例示了在范围从大约30微安到大约100微安的几个振幅上示出了电路180的振荡行为的曲线图300b。与图8一样,图9也示出了在大约6.7MHz上的初级激发频率,以及表现在激发频率的偶数倍上的二、四、六阶谐波(分别为波峰302b,304b和306b)。但是,随着激发信号的振幅在大约30微安到大约100微安之间增大,波峰302b,304b和306b的振幅未连续增大。而是,二阶谐波的振幅在某个转变水平(例如,在图8中大约80微安)之上迅速减小。这个转变水平对应于齐纳二极管沿着反向偏置方向变成导通的,开始影响电路180的振荡行为的水平。
监视出现这种转变的水平可以实现初级天线150与次级天线152之间的耦合度的确定。例如,在一些实施例中,患者可以将外部单元120附在植入单元110在下面的皮肤区域上。处理器144可以着手使一系列欠调节控制信号应用于初级天线150,该一系列欠调节控制信号又在次级天线152上引起次级信号。这些欠调节控制信号可以在扫掠或扫描各种信号振幅水平期间前进。通过监视初级天线150上的所得初级耦合信号(通过与次级天线152上的次级信号耦合生成),处理器144可以确定导致足以激发谐波修正电路154的幅度的次级信号的初级信号(无论是欠调节控制信号还是其它信号)的振幅。也就是说,处理器144可以监视二、四、六阶谐波的振幅,并确定任何偶数谐波的振幅下降的初级信号的振幅。图8和9例示了通过测量非线性谐波检测耦合的原理。这些图形例示了基于6.7MHz激发频率的数据。但是,这些原理不局限于例示的6.7MHz激发频率,而是可以用在任何适当频率的初级信号上。
在一些实施例中,当患者将外部单元120附在皮肤上时,与齐纳二极管的转变水平相对应的初级信号的所确定振幅(可以称为初级信号转变振幅)可以建立基准范围。可以推测,在患者醒着的时候,舌头不会阻塞患者的气道,在自然范围内随着患者呼吸移动,其中初级天线150与次级天线152之间的耦合可以在基准范围之内。基准耦合范围可以包含初级天线150与次级天线152之间的最大耦合。基准耦合范围也可以包含不包括初级天线150与次级天线152之间的最大耦合水平的范围。因此,初始确定的初级信号转变振幅可能相当好地代表非睡眠呼吸暂停状况,可以被处理器144用作确定初级天线150与次级天线152之间的耦合度的基准。可选地,处理器144也可以在一系列扫描期间监视初级信号转变振幅,并将最小值选作基准,因为最小值可能对应于正常呼吸状况期间初级天线150与次级天线152之间的最大耦合状况。
随着患者戴着外部单元120,处理器144可以周期性地扫描一个范围的初级信号振幅,以确定初级信号转变振幅的电流值。在一些实施例中,处理器为扫描选择的振幅的范围可以基于基准初级信号转变振幅的水平(例如,在其附近)。如果周期性扫描导致与基准初级信号转变振幅不同的初级信号转变振幅的确定,则处理器144可以确定相对于基准初始状况发生了改变。例如,在一些实施例中,初级信号转变振幅超过基准值的增大可能指示初级天线150与次级天线152之间的耦合度降低了(例如,因为植入单元发生了移动或植入单元的内部状态发生了改变)。
除了确定是否发生了耦合度的改变之外,处理器144还可以根据观察的初级信号转变振幅确定特定耦合度。例如,在一些实施例中,处理器144可以访问查找表或存储将各种初级信号转变振幅与初级天线150与次级天线152之间的距离(或指示耦合度的任何其它物理量)相关联的数据的存储器。在其它实施例中,处理器144可以根据已知电路组件的运行特性计算耦合度。
通过周期性地确定耦合度值,处理器144可以就地确定最终导致神经调节的调节控制信号的适当参数值。例如,通过确定初级天线150与次级天线152之间的耦合度,处理器144可以与所确定耦合度成比例地或要不然与其相关地选择可以在电极158a,158b上提供调节信号的调节控制信号的特性(例如,振幅、脉冲持续时间、频率等)。在一些实施例中,处理器144可以访问查找表或将调节控制信号参数值与耦合度相关联的存储在存储器的其它数据。这样,处理器144可以响应观察的耦合度调整应用的调节控制信号。
另外或可替代地,处理器144可以在调节期间确定初级天线150与次级天线152之间的耦合度。舌头或植入单元在上面或附近的其它结构,因此,植入单元110可能作为调节的结果而移动。因此,在调节期间耦合度可能发生变化。处理器144可以在调节期间随着其变化确定耦合度,以便按照耦合度变化动态地调整调节控制信号的特性。这种调整可以允许处理器144让植入单元110在整个调节事件期间在电极158a,158b上提供适当调节信号。例如,处理器144可以依照耦合度变化变更初级信号,以便保持恒定调节信号,或按照患者需要使调节信号以受控方式减小。
更具体地说,可以将处理器144的响应与确定的耦合度相关联。在处理器144确定初级天线150与次级天线152之间的耦合度只下降到稍低于预定耦合阈值的状况下(例如,在打鼾期间或在舌头小幅振动或其它睡眠呼吸暂停事件前兆期间),处理器144可以确定只有必要作小响应。因此,处理器144可以选择导致相对较小响应(例如,短神经刺激、小肌肉收缩等)的调节控制信号。但是,在处理器144确定耦合度下降到显著低于预定耦合阈值的情况下(例如,在舌头移动到足以引起睡眠呼吸暂停事件的情况下),处理器144可以确定需要作大响应。其结果是,处理器144可以选择导致较大响应的调节控制信号。在一些实施例中,可能只有将足够的电力发送给植入单元110,才能引起所希望的响应水平。换句话说,处理器144可以根据初级天线150与次级天线152之间的所确定耦合度引起计量的响应。随着确定的耦合度减小,处理器144可以使电力以增加的数量传送。这样的手段可以维持外部单元120中的电池寿命,可以保护电路170和电路180,可以提高解决该类型的所检测状况(睡眠呼吸暂停、打鼾、舌头移动等)的有效性,以及可以使患者更舒适。
在一些实施例中,处理器144可以应用迭代过程,以便选择导致所希望响应水平的调节控制信号。例如,一旦确定了应该生成调节控制信号,处理器144就可以根据一组所确定参数值引起初始调节控制信号生成。如果来自反馈电路148的反馈指示神经已经得到调节(例如,如果观察到耦合度增大),则处理器144可以通过发出欠调节控制信号返回到监视模式。另一方面,如果反馈暗示,作为预定调节控制信号的结果,未发生预定神经调节,或发生了神经的调节,但只局部提供了所希望结果(例如,舌头的移动只局部远离气道),则处理器144可以改变与调节控制信号相联系的一个或多个参数值(例如,振幅、脉冲持续时间等)。
在未发生神经调节的情况下,处理器144可以周期性地增大调节控制信号的一个或多个参数,直到反馈指示发生了神经调节。在发生了神经调节,但未产生所希望结果的情况下,处理器144可以重新评估初级天线150与次级天线152之间的耦合度,并选择以取得所希望结果为目标的调节控制信号的新参数。例如,在神经的刺激使舌头只局部远离患者的气道地移动的情况下,可能希望给予另外的刺激。但是,因为舌头已经远离了气道,所以植入单元110可能更接近外部单元120,因此,耦合度可能增大。其结果是,让舌头移动剩余距离到所希望地点可能要求向植入单元110传送数量比舌头的最后刺激引起移动之前供应的电力小的电力。因此,根据新确定的耦合度,处理器144可以选择旨在让舌头移动剩余距离到所希望地点的刺激控制信号的新参数。
在一种操作模式中,处理器144可以扫描一个范围的参数值,直到实现神经调节。例如,在应用的欠调节控制信号导致指示神经调节合适的反馈的情况下,处理器144可以将最后应用的欠调节控制信号用作生成调节控制信号的起点。与应用于初级天线150的信号相联系的振幅和/或脉冲持续时间(或其它参数)可以按预定数量和以预定速率迭代地增加,直到反馈指示发生了神经调节。
处理器144可以根据初级天线150和次级天线152之间的所确定耦合度确定或导出各种生理数据。例如,在一些实施例中,该耦合度可以指示处理器144可以用于确定外部单元120的位置或患者舌头的相对位置、外部单元120与植入单元110之间的距离。监视耦合度也可以提供像患者的舌头是否正在运动或振动(例如,患者是否正在打鼾)、舌头运动或振动了多少、舌头的运动方向、舌头的运动速率等那样的生理数据。
响应这些所确定生理数据的任何一个,处理器144可以根据确定的生理数据调控对植入单元110的电力传输。例如,处理器144可以选择解决与所确定生理数据有关的特定状况、特定调节控制信号或一系列调节控制信号的参数。如果生理数据指示舌头,例如,正在振动,则处理器144可以确定有可能发生了睡眠呼吸暂停事件,可以通过以选来解决特定状况的数量向植入单元110传输电力来发出响应。如果舌头处在阻塞患者的气道(或局部阻塞患者的气道)的位置上,但生理数据指示舌头正远离气道,则处理器144可以选择不传输电力,并等待确定舌头是否靠自己清障。可替代地,处理器144可以向植入单元110传输小量电力(例如,尤其在确定的运动速率指示正在缓慢地移离患者的气道的情况下),以鼓励舌头继续移离患者的气道,或加速它远离气道的进程。所述的情形只是示范性的。处理器144可以配有使其能够解决具有特殊性的多种不同生理情形的软件和/或逻辑。在每种情况下,处理器144都可以使用生理数据来确定要传输给植入单元110的电力的数量,以便利用适当数量的能量调节与舌头相联系的神经。
公开的实施例可以结合调控对植入单元的电力传输的方法来使用。该方法可以包括确定与外部单元120相联系的初级天线150、与与植入患者的身体中的植入单元110相联系的次级天线152之间的耦合度。确定耦合度可以由位于植入单元外部和可以与外部单元120相联系的处理器144完成。处理器144可以根据确定的耦合度调控电力从外部单元到植入单元的传输。
如前所讨论,耦合度确定可以使处理器能够进一步确定植入单元的地点。植入单元的移动可以对应于可以附着植入单元的身体部分的移动。可以认为这是处理器接收的生理数据。于是,处理器可以根据生理数据调控电力从电源到植入单元的传输。在可替代实施例中,耦合度确定可以使处理器能够确定与植入单元的状况有关的信息。这样的状况可以包括地点,以及与植入单元的内部状态有关的信息。处理器可以按照植入单元的状况,根据状况数据调控电力从电源到植入单元的传输。
在一些实施例中,植入单元110可以包括处在植入单元上的处理器。处在植入单元110上的处理器可以执行针对与外部单元相联系的至少一个处理器所述的所有或一些过程。例如,与植入单元110相联系的处理器可以接收提示植入控制器接通的控制信号,并使调节信号应用于植入电极以便调节神经。这样的处理器还可以监视与植入单元相联系的各种传感器,并这种信息发回给外部单元。处理器单元的电力可以由板上电源供应,或经由传输线从外部单元接收。
在其它实施例中,植入单元110可以是自给自足的,包括它自己的电源和配置成没与外部交互地操作植入单元110的处理器。例如,借助于适当电源,植入单元110的处理器可以监视对象的身体中的状况(经由一个或多个传感器或其它部件),确定那些状况成为调节神经的理由的时间,并生成到电极的调节神经的信号。该电源根据运动或生物功能可以是再生的;或该电源可以像,例如,通过感应那样,周期性地从外部地点再充电。
考虑到本公开的说明和实践,本公开的其它实施例对于本领域的普通技术人员来说是显而易见的。
在作为本发明的示范性实施例的描述的一部分的所附编号段落中描述了本发明的另外方面。每个编号段落独立地代表本发明的单独实施例。
Claims (22)
1.一种在对象体内治疗睡眠呼吸暂停的可植入设备,该设备包含:
配置成植入颏舌肌的区域中的载体;
与该载体相联系的可植入电路,该可植入电路被配置成刺激舌下神经,从而调节颏舌肌;
安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分能量提供给该可植入电路的天线;以及
用于从该可植入电路接收能量的与该载体相联系的至少一个组件,
其中,该可植入电路和该天线具有与外部电路的外部共振频率失配的内部共振频率,以考虑到作为植入对象的身体中的结果的共振频率变化。
2.如权利要求1所述的可植入设备,其中该载体是柔性的。
3.如权利要求1所述的可植入设备,进一步包括安排在该载体上的至少一对调节电极。
4.如权利要求1所述的可植入设备,其中内部共振频率与外部共振频率之间的失配量取决于与该可植入电路相联系的电容。
5.如权利要求4所述的可植入设备,其中该可植入电路包括至少一个微调电容器,以便能够改变与该可植入电路相联系的电容。
6.如权利要求4所述的可植入设备,其中该可植入电路包括多个电容器,其可以有选择地与该可植入电路连接,以便提供与该可植入电路相联系的电容。
7.如权利要求6所述的可植入设备,其中与该可植入电路相联系的电容通过多个电容器的子集来提供。
8.如权利要求6所述的可植入设备,其中该多个电容器的至少一个不用于与该可植入电路相联系的电容。
9.如权利要求4所述的可植入设备,其中与该可植入电路相联系的电容在将该可植入设备植入对象的身体中之前设置。
10.如权利要求4所述的可植入设备,其中要与该可植入电路相联系的所希望电容通过基于共振频率变化的预期值的模拟来确定。
11.如权利要求4所述的可植入设备,其中要与该可植入电路相联系的所希望电容根据如下参数的至少一个来确定:该可植入设备在对象的身体中的放置地点、调节神经所需的能量的数量、存在于该可植入电路上的电子器件的类型、和进入封装该可植入设备的包壳中的湿气的估计量。
12.如权利要求4所述的可植入设备,其中与该可植入电路相联系的电容在封装该可植入设备之前设置。
13.如权利要求4所述的可植入设备,其中确定与该可植入电路相联系的电容,使得当将该可植入设备植入对象的身体中时,该可植入电路的内部共振频率与该外部电路的外部共振频率之间的差值不大于该外部共振频率的30%。
14.如权利要求4所述的可植入设备,其中确定与该可植入电路相联系的电容,使得当将该可植入设备植入对象的身体中时,以至少50%的能量传送效率在该外部电路与该可植入电路之间传送能量。
15.如权利要求1所述的可植入设备,其中该共振频率变化包括该可植入电路的内部共振频率从大约8.1kHz变化到大约7.9kHz。
16.一种配置成植入对象的身体中的单元,包含:
载体;
与该载体相联系和具有可调电容的可植入电路;
安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分接收能量传送给该可植入电路的天线;以及
与该载体相联系和被配置成接收传送给该可植入电路的至少一些能量的至少一个组件,
其中,该可植入电路的内部共振频率通过在将该单元植入对象的身体中之前改变该可植入电路的可调电容有选择地设置,引起该可植入电路的内部共振频率与配置成位于对象的身体外部的外部电路的外部共振频率之间的共振频率偏移。
17.如权利要求16所述的单元,其中将内部共振频率与外部共振频率之间的共振频率偏移用于补偿预期在该单元被植入对象的身体中之后出现的该可植入电路的内部共振频率的漂移。
18.如权利要求16所述的单元,其中要在内部共振频率与外部共振频率之间提供的共振频率偏移的所希望值通过基于内部共振频率的漂移的预期值的模拟来确定。
19.如权利要求16所述的单元,其中该共振频率偏移的数值使得当将该单元植入对象的身体中时,该可植入电路的内部共振频率与该外部电路的外部共振频率之间的差值不大于该外部共振频率的30%。
20.如权利要求16所述的单元,其中该共振频率偏移的数值使得当将该单元植入对象的身体中时,以至少50%的能量传送效率在该外部电路与该可植入电路之间传送能量。
21.一种制造要植入对象的身体中的植入单元的方法,该方法包含:
根据作为将该植入单元植入对象的身体中的结果的内部共振频率的预期共振变化、和根据配置成将能量从对象身体之外的地点传送给该可植入电路的外部电路的外部共振频率,为与该植入单元相联系的天线和可植入电路确定所希望初始共振频率;以及
调整与该可植入电路相联系的至少一个电容,以便将该天线和该可植入电路的内部共振频率有选择地设置成所希望初始共振频率。
22.一种配置成植入对象的身体中的单元,包含:
载体;
与该载体相联系的可植入电路;
安排在该载体上和被配置成从对象身体外部的地点无线接收能量和将至少一部分能量提供给该可植入电路的天线;以及
从该可植入电路接收能量的与该载体相联系的至少一个组件,
其中,该可植入电路和该天线具有与外部电路的外部共振频率失配的内部共振频率,以考虑到作为植入对象的身体中的结果的共振频率变化。
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