CN102573986A - 用于无导线刺激器的具有袋部的神经封套 - Google Patents

用于无导线刺激器的具有袋部的神经封套 Download PDF

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CN102573986A
CN102573986A CN2010800319568A CN201080031956A CN102573986A CN 102573986 A CN102573986 A CN 102573986A CN 2010800319568 A CN2010800319568 A CN 2010800319568A CN 201080031956 A CN201080031956 A CN 201080031956A CN 102573986 A CN102573986 A CN 102573986A
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CN102573986B (zh
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M·A·法尔蒂斯
R·马丁
S·E·斯科特
G·洛布
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SetPoint Medical Corp
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0556—Cuff electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
    • A61N1/0558—Anchoring or fixation means therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36114—Cardiac control, e.g. by vagal stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/3756—Casings with electrodes thereon, e.g. leadless stimulators

Abstract

本发明涉及一种被构造用于保持无导线的、集成的植入式微刺激器的血管外神经封套。神经封套可以包括封套体，该封套体具有用于以可移除的方式在其中容纳植入式装置的袋部或袋。神经封套可以绕神经紧固，从而使装置的电极相对于神经稳定地定位。此外，神经封套驱使来自刺激装置的电流的主要部分进入到神经中，而保护周围组织不受到不希望的刺激。

Description

用于无导线刺激器的具有袋部的神经封套
相关申请的交叉引用
本申请根据35U.S.C.119要求2009年6月9日提交的、名为“用于无导线刺激器的具有袋部的神经封套”的美国临时专利申请号61/185,494的权益。
参考文件的并入
在此通过引用并入本说明书中提及的所有出版物和专利申请，如同专门和单独地指明通过引用并入每个出版物或专利申请。
技术领域
本发明总体上涉及植入式神经刺激器，更具体地涉及一种带有用于以可移除的方式容纳有源无导线刺激设备的袋部的神经封套，以及使用这种神经封套刺激神经的方法。
背景技术
已开发了多种植入式电刺激装置用于多种疾病和失调的治疗性处理。例如，植入式心律转复除颤器(ICD)已用于治疗各种心脏疾病。脊髓刺激器(SCS)或背柱刺激器(DCS)已被用于治疗慢性疼痛紊乱，包括背部手术失败综合症、复合性区域疼痛综合症和外围神经病变。外围神经刺激(PNS)系统已被用于治疗慢性疼痛综合征和其他疾病和紊乱。功能性电刺激(FES)系统已被用于恢复不进行治疗就会麻痹的脊髓损伤患者的末端的部分功能。
典型的植入式电刺激系统可以包括具有在导线上的一个或多个可编程电极的系统，所述电极连接到包含电源和刺激电路的可植入脉冲发生器(IPG)。然而，这些系统可能植入困难和/或耗时，因为电极和IPG通常被植入在单独的区域，因此导线必须穿过人体组织以连接电极和IPG。此外，由于导线通常又细又长，随着时间推移，它们还易受机械损伤。
最近，为解决上述缺点已开发出具有与刺激器本体相连接的集成电极的小型植入式神经刺激器技术，即微刺激器。这项技术允许以单个设备取代上面所描述的典型的IPG、导线和电极。除去导线的几个优点包括：通过消除例如将电极和IPG植入在不同的地方的需要、对设备袋部的需要、通向电极部位的通道、和贴在导线本身上的应变消除件而减少手术时间。因此可靠性显着增加，特别是在软组织和跨关节中，因为有源部件(如导线)现在是刚性结构的一部分，并不会受到由于长时间反复弯曲或挠曲造成的机械损伤。
然而，无导线集成装置趋于比电极/导线组件更大且更重，使其难于使设备稳定地处于相对于神经合适的位置上。没有设备稳定性，则神经和/或周围肌肉或组织可能会由于组件的移动而受到损伤。
因此，仍然需要一种稳定地定位在神经上并且能够使刺激装置容易地去除和/或更换的无导线集成装置。
发明内容
在此所描述的是用于将无导线的、集成的可植入的装置固定于神经的血管外神经封套。该神经封套特别地包括袋或袋部。刺激装置的封套电极构造允许装置稳定地邻近神经，如迷走神经定位。此外，封套电极构造还具有将大部分电流驱使到神经中的特性，同时保护周围组织免受不希望的刺激。在此还描述了使用这种神经封套紧固无导线微刺激器的方法以及使用通过这种封套固定的微刺激器进行刺激的方法。
使用带微刺激器的无导线的封套有许多优点，包括相对于没有无导线封套的系统减少包封(例如大约100微米)，因为在无导线封套上“牵引”更少。此外，可以可靠地连接到神经上并且将微刺激器保持在位的无导线封套可以允许在保持相对于神经同样定位的情况下对微刺激器进行调校或替换。
在本发明的一种实施例中，神经封套总体包括封套体或支架，所述封套体或支架由柔韧性材料制成，如医药级软聚合物材料(如SilasticTM或TecothaneTM)形成的封套或套筒，具有在其中限定的袋部或袋，用于以可移除的方式容纳无导线的刺激装置。无导线的刺激装置被定位在袋部或套筒中，从而使装置的电极靠近要刺激的神经定位。袋部可以通过刺激装置和封套体的内表面之间的空间限定，或者可以包括连接到封套体上的用于容纳刺激装置的袋状结构。该神经封套可以被联接到神经、包含神经的外周鞘，或根据所希望的稳定水平被联接到这两者上。
神经封套可以通过下述方式植入。首先从神经的外周鞘解剖出神经，如迷走神经，用神经封套裹住神经，将神经封套联接或缝合到神经或鞘中的任意之一，以及将刺激装置插入到封套体中的袋部或袋中，从而使刺激装置靠近神经。
例如，在此所描述的是用于确保无导线的微刺激器与神经稳定通信的神经封套。神经封套可以包括：封套体，所述封套体具有用于神经通过的在封套体的长度内延伸的通道；在所述封套体内部的袋部，所述袋部被构造为以能够移除的方式保持无导线微刺激器；以及沿所述封套体的长度延伸的细长的开口缝隙，所述缝隙被构造为打开的以提供通向袋部的出入口。
所述神经封套还可以包括在封套体内的内部的电触点。例如，所述内部的电触点可以被构造用于使微刺激器和神经电联接。在一些变型中，所述神经封套还包括在所述封套体外表面上的外部的电触点，所述外部的电触点被构造用于与微刺激器联接。
在一些变型中，所述封套体包括被构造用于使微刺激器在神经封套内电绝缘的屏蔽。封套体可以具有一致的厚度或者可以具有不一致的厚度。例如，封套体可以具有在约5密耳(mil)和约20密耳之间的厚度。
在一些变型中，神经封套的外表面基本上是光滑和防损伤的。神经封套的神经外表面可以是圆化的和/或顺应的。例如，本体可以顺应于被植入封套和/或微刺激器的本体的区域。
在一些变型中，通道包括支撑通道，所述支撑通道被构造用于支撑在其中的神经，以防止对神经的挤压。
细长的开口缝隙可以以互联形样式沿所述封套体的长度延伸。在一些变型中，所述缝隙沿所述封套体的侧面延伸，靠近通道。在其他的变型中，所述缝隙沿所述封套体的顶部延伸，与通道对置。
神经封套还可以包括一个或多个在细长的开口缝隙中被构造用于帮助确保缝隙封闭的联结部位。例如，所述联结部位可以是孔或用于缝合线的通道。
在一些变型中，封套体由柔韧性的和生物兼容性的聚合物形成，例如聚合物生物相容性材料，如有机硅聚合物。
在此还描述了用于确保无导线微刺激器与神经稳定通信的神经封套，所述神经封套包括：绝缘的封套体，所述封套体具有用于神经通过的在封套体的长度内延伸的神经通道，其中所述封套体使微刺激器在封套体内电绝缘；在神经通道内的导电表面，所述导向表面被构造用于接合在微刺激器上的一个或多个电触点；在所述封套体内部的袋部，所述袋部被构造为以能够移除的方式保持无导线微刺激器；以及沿所述封套体的长度延伸的细长的开口缝隙，所述缝隙被构造为打开的以提供通向袋部的出入口。
如上面所提到的，神经封套可以包括在所述封套体外表面上的一个或多个外部的电触点，所述外部的电触点被构造用于与微刺激器联接。
在一些变型中，神经封套体具有一致的厚度。在另一些变型中，神经封套体具有不一致的厚度。封套体可以具有在约5密耳和约20密耳之间的厚度。
神经封套的外表面可以基本上是光滑和防损伤的。例如，神经封套的外表面可以是轮廓匹配的。
在一些变型中，穿过神经封套的通道包括支撑通道，所述支撑通道被构造用于支撑在其中的神经，以防止对神经的挤压。
在一些变型中，细长的开口缝隙以互联形样式沿所述封套体的长度延伸。例如，互联的样式可以是“之”字形样式或正弦曲线样式。
在此还描述了一种植入与迷走神经通信的无导线微刺激器的方法，所述方法包括：露出迷走神经；将具有神经封套体的神经封套的缝隙打开，其中所述缝隙沿所述神经封套体的长度打开；将所述神经封套绕迷走神经放置，从而使神经位于在所述神经封套的长度上延伸的通道内；将无导线的微刺激器插入到所述神经封套的袋部中；以及确保所述神经封套的缝隙封闭，从而无导线的微刺激器与神经电通信，并且在所述神经封套体内电绝缘。
在一些变型中，确保所述神经封套的开口缝隙封闭的步骤包括确保缝隙，使得无导线的微刺激器接合神经封套体内的内部的电触点。无导线的微刺激器可以接合被构造为提供环绕通道内的神经的周向刺激的内部电触点。
确保的步骤可以包括将缝隙缝合封闭。在一些变型中缝隙可以自我封闭。例如在封套中有足够的张力通过其本身保持其封闭。在一些变型中，可以使用可溶解的缝合线保持其封闭，直到本体包封该缝隙。
该方法还可以包括测试微刺激器的步骤以确认与神经的电通信。
在一些变型中，放置神经封套的步骤包括绕迷走神经放置超尺寸的神经封套。
在此还描述了一种植入与迷走神经通信的无导线微刺激器的方法，所述方法包括下列步骤：露出迷走神经；将具有神经封套体的神经封套的缝隙打开，其中所述缝隙沿所述神经封套体的长度打开；将所述神经封套绕迷走神经放置，从而使神经位于在所述神经封套的长度上延伸的通道内；将无导线的微刺激器插入到所述神经封套的袋部中，从而使所述微刺激器与神经封套内的一个或多个内部的电触点通信；以及封闭所述神经封套的缝隙，从而使神经与一个或多个内部的电触点通信。
在一些变型中，无导线的微刺激器和内部的电触点被构造为提供环绕通道内的神经的周向刺激。封闭的步骤可以包括确保所述神经封套的缝隙封闭。例如，封闭的步骤可以包括将所述缝隙缝合封闭。放置神经封套的步骤可以包括绕迷走神经放置超尺寸的神经封套。
本发明的上述概要并非意在描述每个示出的实施例或本发明的每一种实施方式。接下来的附图和说明更加具体地举例说明这些实施例。
附图说明
图1根据本发明的一个实施例以立体图示出了带有贴近神经植入的刺激装置的神经封套；
图1A以俯视图示出了带有图1的刺激装置的植入的神经封套；
图1B以俯视图示出了根据本发明的一种替代的实施例带有刺激装置的植入的神经封套；
图2以前视图示出了根据本发明的一种实施例的带应变消除件的植入的神经封套；
图3以前视图示出了根据本发明的一种实施例的带有缝合孔的植入的神经封套；
图4以打开视图示出了带有图3的缝合孔的神经封套；
图5以俯视图示出了用于图1的植入的神经封套的封闭装置；
图6以立体图示出了在图1的神经封套的袋部中的刺激装置的袋形缝合术；
图7A以俯视图示出了根据本发明的一种实施例的具有顺应性保护套的神经封套；
图7B以前视图示出了图7A的神经封套；
图8A以俯视图示出了根据本发明的一种实施例的打开的神经封套；
图8B以前视图示出了图8A的神经封套；以及
图8C以俯视图示出了封闭结构下的图8的神经封套；
图9A和9B以侧视图示出了封套本体壁部的一个截面，分别显示出一致的厚度和变化的厚度；
图10A-10D示出了如在此所描述的神经封套的一种变型。图10A示出了端视图，图10B是侧面立体图，图10C是侧视图，以及图10D是穿过与神经连接的装置的纵向截面，示出了内部的特征，包括微刺激器；
图11A-11D示出了神经封套的另一种变型。图11A示出了端视图，图11B是侧面立体图，图11C是侧视图，以及图11D是穿过与神经连接的装置的纵向截面，示出了内部的特征，包括微刺激器；
图12示出了可以用在在此所描述的神经封套中的微刺激器的一种变型；
图13A示出了可以如在此所描述地使用的微刺激器的另一种变型的立体图。图13B和13C分别是在图13A中示出的微刺激器的端视图和仰视图；
图14A和14B分别示出了神经封套的另一种变型的侧视图和端视图；
图15A-15C分别示出了与神经相连接的如在图14A中所示出的神经封套的俯视图、侧视图和截面图。图15D是穿过神经封套的中央的截面，该神经封套具有固定在此处的微刺激器；
图16是与在图14A-15D中所示的类似的微刺激器的内部端视图；
图17以截面视图示出了神经封套的另一种变型的内侧；
图18以侧面立体图示出了图17中所示的顶部打开的神经封套；
图19以侧面立体图示出了侧面开的神经封套；
图20是神经封套的底部的透明视图，示出了神经通道；
图21以侧视图示出了神经封套的另一种变型；
图22A-22H示出了嵌入如同在此所描述的神经封套的神经封套的步骤；
图23示出了当神经封套仅是松驰地布置在神经上时模拟电流损耗的等效电路。
本发明可被修改为多种改进方案和替代形式，其特征已在附图中以实例的形式示出，并且将进行详细地描述。然而，应理解的是，这样做的意图并非将本发明仅限于所描述的特殊实施例。相反，意图是覆盖落入由权利要求书所定义的本发明的精神和范围内的所有改进方案、等效方案和替代方案。
具体实施方式
本发明的实施例涉及保持装置，例如支架或封套，所述支架或封套将刺激装置的有源触点(即电极)贴靠目标神经定位，将电流从电极导入到神经中。保持装置还抑制或防止电流流出到周围组织中。
参考图1，适用于固定刺激装置的一个例子的神经封套100与神经102联接。神经102可以包括人类身体中的任何被标靶用于治疗性处理的神经，例如迷走神经。神经封套适配器100总体上包括外部支架或封套体104，该外部支架或封套体可以包括任意的医药级材料，例如SilaticTM品牌的有机硅弹性体，或TecothaneTM的聚合物。
总的来说，神经封套包括具有(或形成)用于可移除地容纳有源的植入式刺激装置108的袋或袋部106的封套体104，所述植入式刺激装置108在该刺激装置108的表面上靠近神经102处具有一个或多个集成的无导线电极110。如图1和图1A所示，神经封套100包绕住神经102，使得电极110被靠近神经102定位。
触点或电极110可以被直接贴靠神经102定位(如在图1A中所述)或紧密靠近神经102(如在图1B中所示)。特别地参考图1B，电极110和神经102紧密的靠近留出一个可以被流体或结缔组织自然填充的间隙或空间112。在本发明的一个实施例中，电极110和/或封套体104的内表面可以包括任意的类固醇涂层，以帮助减少局部炎症反应和高阻抗组织的形成。
在一个实施例中，用于容纳刺激装置108的袋部106是由神经102和封套体104的内表面之间的敞开空间限定的。刺激装置108可以被封套体104被动地保持在袋部106内，或者可以通过紧固措施(例如缝合)被主动地保持在封套体上。在另外的实施例中，袋部106可以包括与封套体104连接的袋状结构，刺激装置108可以被插入到该袋状结构中。刺激装置108可以通过将该装置108简单地插入到袋部中而被动地被保持在袋状袋部内，或者可以通过紧固措施主动地进行保持。袋状的袋部可以被布置在封套体104的内部或外部。袋状的袋部106和/或封套体104可以包括进入开口以允许将电极直接靠近或接近神经102定位。
封套体104可以具有均匀的厚度或变化的厚度，如在图9A和9B中所示。封套体104的厚度可以被确定为一旦插入刺激装置减小装置可触及的轮廓。在一个实施例中，封套体的厚度的范围可以是从大约1密耳至大约30密耳，或者从大约5密耳至大约20密耳。在图9B中所示出的一个实施例中，封套104可以在封套的顶部和底部部分具有较大的厚度，在容纳有刺激装置的中间部分具有较小的厚度。
使刺激装置靠近神经或神经束需克服的主要障碍是沿软组织中的脆弱神经联结构成刺激装置的刚性结构。在本发明的一个实施例中，这个问题是通过将神经102和装置108罩在封套体104中实现的，所述封套体包括如上面所描述的低硬度材料(如SilasticTM或TecothaneTM)，并且顺应地围绕神经102。此外，如在图2中所示，封套体104在其端部可以包括应变消除件114以减少或防止末端扭转并防止神经102扭结。应变消除件114可以卷绕在神经102周围，并且可以微调到所需要的尺寸，例如神经102的尺寸。此外，应变消除件114可以是渐缩的。在一些变型中，形成里面可以放置神经的通道的神经封套的侧端部是渐缩的，并且具有渐细的厚度，以对神经提供一定的支撑。在一些变型中，穿过神经封套的、里面可以放置神经的通道被加强以当神经位于封套内时，防止或限制对神经或相关的血管结构的轴向负载(例如碰撞)。
在封套体104的上述设计或构造的情况下，封套体104在神经102上的任何竖直移动对电性能不是至关重要的，但是却能够造成装置108和神经102之间的摩擦，该摩擦可能会对神经102造成潜在伤害。为此，装置108应易于上下移动神经102而不产生显著的摩擦，却足以固定在神经102上，从而最终形成结缔组织并有助于将装置108保持在位。挑战是将装置108稳固，从而使其能够在数周内被结缔组织进一步生物稳固。
神经封套100不应环绕会相对于神经移动的肌肉或绷带稳固。因此，参照图3和图4，神经封套100还可以包括连接装置，例如缝合孔或缝合片，用于将带有装置108的封套体104连接并稳固于神经束或神经102和含有神经102的外周鞘中的至少一个。在本发明的一个实施例中，例如在图3中所示，封套体104可以包括缝合孔106，所述缝合孔可以与缝合线一起使用以将带有装置108的封套体104联接到外周神经鞘上。在本发明的一种替代的实施例中，如图4所示，带有缝合孔116的缝合片118从封套体104的一侧或两侧延伸出去。
可以使用多种稳固机构，包括缝合片和孔、钉、结、手术粘合剂、扎带、粘扣带以及多种联接机构的任何一种。例如，图3和图4示出了可以通过用于软组织的可吸收的缝合线或需要刚性固定的缝合线固定在外周鞘上的缝合片和孔。
图5示出了缝合线120将带有装置108的封套体104夹紧或固定到手术选用的拉紧程度。根据所希望的稳固性和解剖学考量，缝合线120可紧可松。如在图5中所示，可以留有空隙122，只要封套适配器100被充分地固定于神经102，有一个限制被设定为神经直径，以防止神经102中的脉管系统压缩。手术粘合剂(未示出)可以与缝合线120结合使用于随神经组织移动的周围组织。
阻碍封套适配器100的肌肉运动可能向神经102传递不希望的应力。因此，在本发明的一种实施例中，可以向封套体104的一个或多个表面添加低摩擦表面和/或亲水性涂层以提供减少或防止相邻的组织影响神经封套100的稳固性的进一步的机构。
图6示出了带有以可移除的或袋状的方式紧固在封套体104的袋部或袋106中的刺激装置的神经封套100。通过使用可重复封闭的袋106，有源刺激器装置108可以从封套体104中被移出或更换而不会伤害或危及周围的解剖学结构和组织。装置108可以通过多种紧固装置124，例如缝合线、钉、结、拉链、粘扣带、按扣、纽扣，及其组合，中的任意一种紧固在封套体104中。在图6中示出了缝合线124。解开缝合线124允许进入到袋106中以移除或更换装置108。与传统的封套类导线不相同，结缔组织的囊可以随着时间推移自然地包住神经封套100。因此，非常可能的是会有必要对装置108进行触诊以确定装置108的位置并且切开结缔组织囊以接近缝合线124和装置。神经封套100的可移除/更换的特性比其他封套类型导线更为有利，因为这样的导线不可能因为与标靶神经和关键脉管系统相纠缠而不能够被移除。
如上所述，必须小心地控制对神经102的压缩。对神经102的过度压缩可能导致脉管断裂并造成神经组织死亡。通过大尺寸的或尺寸正好的神经封套100可以控制压缩，从而当袋部缝合线124被最大程度地拉紧时，神经直径不会被减少小于测量直径。由SilasticTM或TecothaneTM材料制成的封套成本相对较低，并且因此为实施神经封套100的植入的外科医生提供多种尺寸以更好的避免神经压缩。
现有技术中的商业封套系统，诸如装置等微型刺激器仍然非常大，足以被患者感觉到并且触及。参考图7，为了避免这种触及，神经封套100还可以进一步包括形状顺应于例如颈动脉鞘中的解剖学结构，的保护罩126。在这个实施例中，神经封套100环绕迷走神经被固定，同时神经封套还将装置108隔离防止其与内部的颈静脉(IJV)132和共同的颈动脉134接触。保护罩126还进一步隔离装置108与其他周围组织。在保持如SilasticTM或TecothaneTM材料的柔顺性的同时使整个封套适配器100的轮廓最小化是十分关键的。在本发明的一种实施例中，保护罩126由PET材料(例如Dacron
Figure BPA00001497775500121
)形成，可任选地涂以SilasticTM或TecothaneTM形成薄的、柔顺的结构，这种结构在需要时允许组织分离。
当神经不能提供足够的结构强度以支撑神经封套适配器100时，在封套体104中或封套体104上可以包含附加结构。由于高度的解剖学差异，这种方案必须需要外科医生利用极其专用化解决方案的技巧。图8A示出了带有从封套体104延伸出的可缠绕的保持部分128的变尺寸神经封套100。如在图8C中所示，封套体104绕神经102紧固，而保持部分128绕鞘或其他周围解剖学结构，例如IJV 132和/或颈动脉134紧固。如图8B中所示，可缠绕的保持部分128可以包括紧固装置130，例如缝合孔，用于将整个神经封套128绕所希望的解剖学结构紧固。这种构造使得可以如前面的实施例中一样，穿过袋部106接近装置108，同时适于多数解剖学差异以获得所希望的神经封套100在神经102上的稳固性。
图10A至图10D示出了神经封套的一种变型，该神经封套包括封套体，封套体形成通道(神经可以被放置于该通道中)和沿该神经封套体的长度形成的缝隙。在这个例子中，神经封套体在位于神经通道上方的封套体内部也包括一个袋状区域。本体的顶部(背离神经通道)包括一条沿其长度方向的长缝隙1003，形成开口。封套体可以通过拉开形成一个或多个侧翼的边缘而被沿着缝隙分开。在图10A所示出的例子中，该缝隙可以被分开以将神经封套的内侧露出，允许神经被放置在内部通道中，从而使封套绕神经定位。同一个缝隙还可以用于插入微控制器。在一些变型中，可以使用单独的开口(缝隙或侧翼)以接近用于微控制器的袋部或袋。
图10B示出了神经封套的立体图，该神经封套在微控制器被插到神经上后(例如迷走神经)保持微控制器。图10C示出了同上的侧视图。图10D展示了图10C的示图的截面，因此示出了位于穿过神经封套形成的通道内的神经，以及贴靠地保持在神经封套内的微刺激器，从而使微刺激器与神经通过在两者之间共同的表面进行电通信。在如下面将讨论的一些变型中，微刺激器被保持在单独的、在可能的情况下是绝缘的间隔间中，并且这种与神经的电接触是通过一个或多个将通过内部触点将微刺激器与神经联接的内部导线产生的。
如图10A至10D所示的示例性的封套具有顺应性的结构，如从图10D的截面视图可见，在这种结构中壁厚相对恒定。相反，图11A至11D示出了神经封套的一种变型，在这种变形中，壁厚沿周长变化。这种不一致的厚度可以有效地为装置相对于周围组织提供缓冲，即使患者移动或者触及这个区域。这种方法还有防止神经受到冲击的附加益处。类似地，变化的厚度可以实现平顺的过渡，并且帮助封套顺应于周围的解剖学组织构造。
例如，图11A示出了端视图(以示例性的尺寸示出)。应注意的是，在此提供的所有的图和示例、示出的或描述的尺寸都仅用于举例说明。实践中，尺寸可以是加减(+/-)所示出的值的一些百分比(例如+/-5％，10％，15％，20％，25％，30％，40％，50％等)。在图11D中所示的装置的截面示出了壁部的不一致的厚度。
在图10A至图10D和在图11A至图11D中所示出的两种神经封套变型都基本上是圆化或顺应的，具有不产生损伤的(或防止损伤的)外表面。如已提到的，这种相对光滑的外表面可以增强舒适性，并且限制神经封套在组织内的包封。
如从图10D和11D可见，微刺激器在被插入到神经封套中时，通常位于神经的长度方向的上方(在附图的参考平面中)。在一些变型中，微刺激器包括轮廓匹配的外表面，在该外表面上布置有一个或多个触点(用于接触神经或神经封套内的内部导体)。例如，图12示出了微刺激器1201的一种变型。在这个例子中，微刺激器在其外表面上包括一个或多个触点，通过这些触点向神经提供刺激。图13A示出了微刺激器1301的另一种变型，在这种变型中，外表面(图13A的底部)弯曲，以在将微刺激器插入到神经封套中时，帮助形成环绕神经的通道。图13B展示了端视图，示出了沿微刺激器的长度延伸的通道凹部1303，以及图13C示出了看向通道区域的仰视图。实践中，所示出的微刺激器可以放置在神经封套内部，并且至少部分地环绕神经定位。因此，该微刺激器可有助于保护位于该通道内的神经。如上面所提到的以及将在下面更详细地描述的，神经不必贴靠在触点上，因为电流可以从神经封套内部被传导到神经上，所述电流即使在封套过大或仅能宽松地环绕神经时也能够充分地绝缘以防止电流的过度泄漏或外溢。此外，神经封套可以包含一个或多个使电流可以经由一个或多个内部触点或导线被分配到神经上的内部触点，包括沿周向环绕神经。
图14A和14B示出了神经封套的另一种变型。在这个示例中，形成开口的缝隙沿装置的长度方向位于上表面上(与神经通道对置)。该缝隙以互联形样式形成。在图14A中，缝隙形成了“之”字样式，虽然也可以使用其他互联形样式。例如，可以使用正弦形或方波形的样式。该互联形的样式可以分散封闭环绕神经和微刺激器的应力，并且可以在封套已经被定位且微刺激器已经被插入时更容易地封闭封套。图14B示出了在图14A所示的同样的封套的端视图。
图15A至15C以俯视图和侧视图示出了与神经连接的如图14A所示的类似的封套。在这个示例中，神经穿过内部通道延伸，并且在两端从开口(可以是卵形的，如在图14B中所示)延伸出去。在图15C中，沿装置长度方向的截面示出了微刺激器被定位在神经上方的袋(腔)中。该微刺激器可以被封套的壁部保持在位。如在图15D的横截面视图中所示，可以使用顺应性的微刺激器(例如在图13A至13C中所示出的那一个)。顺应性的微刺激器的触点1503被布置在装置的底部。
如上面简要提及的，在神经封套的一些变型中，封套体的内表面包括一个或多个内部触点，所述内部触点被构造用于与保持在袋内部的微刺激器联接，并且向布置在通道内穿过神经封套的神经传输任何施加的能量(或从神经接收能量)。可以布置内部的导线，从而它可以向底侧(沿通道的底部区域)提供电流，或者在神经位于通道内时绕神经的侧面提供电流。在一些变型中，内部导体或导线被构造为环绕通道，从而可以沿周向刺激神经，优化所施加的刺激。图17是神经封套的长截面，示出了封套的内侧以及示出了具有可以向神经的底侧施加刺激的内部导线1703的神经封套的变型。这个内部导线可以由任何具有生物兼容性的导电材料形成，包括金属、导电塑料或类似的。内部导线可以包括露出的电极表面1703用于产生与神经的接触。电极可以是有源触点，也由任何合适的导电材料形成(例如金属、导电聚合物、编织材料等)。在一些变型中，对该内部导线进行涂层或处理以帮助增强在微刺激器和神经之间能量的传输。环绕导线的周向刺激或导电可以减少阻抗并确保对神经束进行一致的横截面刺激。
图19示出了在此所描述的神经封套的另一种变型。在该示例中，神经封套包括缝隙1903和用于微刺激器的袋部，该缝隙沿装置的一侧，靠近神经通道，该神经通道可以被打开(例如通过拉开封套的侧翼或侧面)以将神经通道露出。
在此所描述的多种神经封套变型都可以例如通过沿缝隙或铰接区域将其裂开被打开并且绕神经定位。该装置被构造为使得它们具有足够的回弹性以自我关闭，或者在缝隙区域的边缘被合拢时保持关闭。因此，该设备可以具有促使其关闭的形状记忆功能。在一些变型中，如已经提到的，一旦它们已经被定位在神经上并且微刺激器已经被定位在袋部中，则使它们至少暂时地保持关闭是有用的。因此，该装置还可以包括一个或多个关闭元件。例如该装置可以包括用于将装置缝合关闭的缝合孔或出入口。在一些变型中，神经封套包括按扣或其他紧固元件。在一些变型中，如在图6和18中所示，可以用可溶解的缝合线将装置缝合关闭。在插入数周或数月后，神经封套就会被周围组织包封或吞并，并且将被这种包封保持关闭。因此，这种可溶解的缝合线仅仅是在生物整合和包封发生前保持封套关闭以进行最初的锚定。
在此所描述的所有的神经封套还可以包括一个或多个朝向神经封套体外侧的外部导线或触点，所述外部导线或触点用于刺激神经封套外侧的组织，而不仅是在通道内穿过封套的神经。图21示出了具有外部导线的神经封套的一种变型。在这个示例中，神经封套包括两个与保持在神经封套袋部中的微刺激器连接(通过神经封套体的壁部)的外部触点2103。除了(或替代)刺激，这种外部导线可以被用于进行感测。例如，这些电触点可以被用于感测其他生理现象，例如肌肉刺激和/或心脏功能。这些信号可以被用于辅助标靶神经刺激的同步以最小化标靶刺激的矫作物。这种信号对于可靠的远程感测来说可以太过微弱，然而微刺激器(被隔绝在神经封套的壳体内)的位置可以允许精确且可靠的感测。
神经可以被置于穿过神经封套的受支撑的通道内。如在图20中所示，通道2003可以被形成为具有大体光滑的侧面，从而防止对神经和关联组织的伤害。在一些变型中，穿过封套的神经通道被加固以防止在神经上封闭时，封套对装置产生压迫或过度紧固。支撑部可以由与形成神经封套体不同的材料形成，或者由相同材料的增厚区域形成。虽然可以使用多种尺寸的神经封套(例如大、中、小)，在一些变型中，可以使用超大尺寸的神经封套，因为绝缘的封套体会防止电流从微刺激器向周围组织泄漏。
总的来说，神经封套体可以是电绝缘的，在工作期间防止电荷从微刺激器泄漏。在一些变型中，神经封套包括足够使神经封套内的微刺激器电绝缘的屏蔽或绝缘。屏蔽材料可以特别地包括电绝缘材料，包括聚合物绝缘体。
可以以数学方式利用如在图23中所示的微刺激器的等效电路示出，来自微刺激器的电流并未明显地从即使宽松地施加的神经封套流出。这就允许超大尺寸神经封套的使用，而不需要严格的尺寸或不会产生压缩神经的风险。
例如，假设横截面为Narea的神经被由神经封套封闭的流体柱Farea环绕，在神经封套中，在微刺激器内例的触点分隔Espacing(中点到中点)并具有宽度Ewidth，以及环绕流体柱和神经Edegrees，可以看出，电流会经过电极的中点和神经封套的端部之间的距离(该距离由距离Dguard定义)泄露到外面。
电模型(在图23中示出)由驱动经过DC绝缘电容器(可选择Ciso2)、经过各电极的电容(Cdl1和Cdl2)的电流源。电流从电极流经路径RS或Rlp1+Rb+Rlp2。作为电流的一部分流经RS的地方提供了有效的工作，并且流经Rlp1+Rb+Rlp2的电流流到装置外侧，可能会引起不希望的影响。
如果神经具有紧配合，则所有流经RS的电流都会用于进行刺激，但在松配合的情况下，仅有电流的一部分可以刺激神经。基于此模型，可见(假设神经和流体柱形成由长轴a和短轴b定义的椭圆，以及脉冲宽度短且电容大)仅能评估实数阻抗和效率。
电极表面积被确定用于评估阻抗的复数部分：Farea＝π*aF*bF以及Narea＝π*aN*bN。
假设容纳流体和神经的封套的阻抗具有近似的电导系数ρ且电极以Espacing间隔，则传导量的实数电阻是：Rworking＝Espacing*ρ/Farea，其中通过Rwasted＝2*Dguard*ρ/Farea+Rbulk计算出应最大化的损耗电阻，其中Rbulk被定义为在封套两端之间的自由场电阻。
因此，实数电流输入到POD中的效率(η)是Rwasted/(Rworking+Rwasted)，在神经尺寸不足的情况下，假设组织和流体柱的传导率大约相等，则刺激效率被定义为：ηT＝η*Narea/Farea。
插入的方法
在手术中，可以将在此所描述的任何装置绕神经布置，以及以任何合适的方式将微刺激器插入到神经封套中。图22A至22H示出了用于绕神经施加神经封套并插入微刺激器的方法的一种变型。在该示例中，患者准备绕迷走神经添加神经封套以将微刺激器装置相对于神经牢固地进行保持(图22A)。然后沿着面部静脉和肩胛舌骨肌(图22B)之间的兰格(Lange)折痕在皮肤中形成切口(≈3厘米)，并缩回胸锁乳突肌以接近颈动脉鞘(图22C)。随后IJV被反射，并且从颈动脉壁分离出≤2厘米的迷走神经。
在一些变型中，可以使用定径器来测量迷走神经(例如直径)以选择合适的微刺激器和封套(例如小、中、大)。在该方法的一些变型中，如上所述，可以使用超尺寸的封套。随后神经封套被放置在神经下方，同时进入到神经封套中的开口朝向外科医生(图22D)，这使得能够接近神经和保持微刺激器的袋部。随后可以将微刺激器插入到封套内侧(图22E)，同时确保微刺激器触点找准迷走神经，或者以任何内部触点/导线与迷走神经通信。随后可以将神经封套缝合封闭(图22F)。在一些变型中，随后可以对微刺激器进行测试(图22G)以确定装置正在工作并且已联接到神经上。例如，可以使用一种覆盖在消毒的塑料盖件下的外科测试装置激活微刺激器并且执行系统完整性以及阻抗检测，然后关闭微刺激器。若必要的话，该程序可以重复以正确地定位和连接微刺激器。一旦完成和验证，则可以闭合切口(图22H)。
本发明可以按照其他特定形式实现而不脱离其实质属性；因此，示出的实施方式应当完全被认为是示范性的而非限制性的。在此提供的权利要求是为了确保本申请适于建立外国优先权，并无其他目的。

Claims (37)

1.一种神经封套，用于确保无导线微刺激器与神经稳定通信，所述神经封套包括：
封套体，所述封套体具有用于神经通过的在封套体的长度内延伸的通道；
在所述封套体内部的袋部，所述袋部被构造为以能够移除的方式保持无导线微刺激器；以及
沿所述封套体的长度延伸的细长的开口缝隙，所述缝隙被构造为打开的以提供通向袋部的出入口。
2.按照权利要求1所述的神经封套，还包括在封套体内的内部的电触点。
3.按照权利要求2所述的神经封套，其中所述内部的电触点被构造用于使微刺激器和神经电联接。
4.按照权利要求1所述的神经封套，还包括在所述封套体外表面上的外部的电触点，所述外部的电触点被构造用于与所述微刺激器联接。
5.按照权利要求1所述的神经封套，其中所述封套体包括被构造用于使所述微刺激器在所述神经封套内电绝缘的屏蔽。
6.按照权利要求1所述的神经封套，其中所述封套体具有一致的厚度。
7.按照权利要求1所述的神经封套，其中所述封套体具有不一致的厚度。
8.按照权利要求7所述的神经封套，其中所述封套体的厚度在约5密耳和约20密耳之间。
9.按照权利要求1所述的神经封套，其中所述神经封套的外表面基本上是光滑和防损伤的。
10.按照权利要求1所述的神经封套，其中所述神经封套的外表面是圆化的。
11.按照权利要求1所述的神经封套，其中所述通道包括支撑通道，所述支撑通道被构造用于支撑在其中的神经，以防止对神经的挤压。
12.按照权利要求1所述的神经封套，其中所述细长的开口缝隙以互联形样式沿所述封套体的长度延伸。
13.按照权利要求1所述的神经封套，其中所述缝隙沿所述封套体的侧面延伸，靠近通道。
14.按照权利要求1所述的神经封套，还包括在细长的开口缝隙中的被构造用于帮助确保缝隙封闭的联结部位。
15.按照权利要求1所述的神经封套，其中所述封套体由柔韧性的和生物兼容性的聚合物形成。
16.一种神经封套，用于确保无导线微刺激器与神经稳定通信，所述神经封套包括：
绝缘的封套体，所述封套体具有用于神经通过的在封套体的长度内延伸的神经通道，其中所述封套体使微刺激器在封套体内电绝缘；
在神经通道内的导电表面，所述导电表面被构造用于接合微刺激器上的一个或多个电触点；
在所述封套体内部的袋部，所述袋部被构造为以能够移除的方式保持无导线微刺激器；以及
沿所述封套体的长度延伸的细长的开口缝隙，所述缝隙被构造为打开的以提供通向袋部的出入口。
17.按照权利要求16所述的神经封套，还包括在所述封套体外表面上的外部的电触点，所述外部的电触点被构造用于与所述微刺激器联接。
18.按照权利要求16所述的神经封套，其中所述封套体具有一致的厚度。
19.按照权利要求16所述的神经封套，其中所述封套体具有不一致的厚度。
20.按照权利要求19所述的神经封套，其中所述封套体的厚度在约5密耳和约20密耳之间。
21.按照权利要求16所述的神经封套，其中所述神经封套的外表面基本上是光滑和防损伤的。
22.按照权利要求16所述的神经封套，其中所述神经封套的外表面是轮廓匹配的。
23.按照权利要求16所述的神经封套，其中所述通道包括支撑通道，所述支撑通道被构造用于支撑在其中的神经，以防止对神经的挤压。
24.按照权利要求16所述的神经封套，其中所述细长的开口缝隙以互联形样式沿所述封套体的长度延伸。
25.按照权利要求16所述的神经封套，还包括在细长的开口缝隙中的被构造用于帮助确保缝隙封闭的联结部位。
26.按照权利要求16所述的神经封套，其中所述封套体由柔韧性的和生物兼容性的聚合物形成。
27.一种植入与迷走神经通信的无导线微刺激器的方法，所述方法包括：
露出迷走神经；
将具有神经封套体的神经封套的缝隙打开，其中所述缝隙沿所述神经封套体的长度打开；
将所述神经封套绕迷走神经放置，从而使神经位于在所述神经封套的长度上延伸的通道内；
将无导线微刺激器插入到所述神经封套的袋部中；以及
确保所述神经封套的缝隙封闭，从而无导线微刺激器与神经电通信，并且在所述神经封套体内电绝缘。
28.根据权利要求27所述的方法，其中确保所述神经封套的开口缝隙封闭的步骤包括确保缝隙，使得无导线微刺激器接合神经封套体内的内部的电触点。
29.根据权利要求27所述的方法，其中所述无导线微刺激器接合内部的电触点，所述内部的电触点被构造为提供环绕通道内的神经的周向刺激。
30.根据权利要求27所述的方法，其中确保的步骤包括将缝隙缝合封闭。
31.根据权利要求27所述的方法，还包括测试微刺激器的步骤以确认与神经的电通信。
32.根据权利要求27所述的方法，其中放置神经封套的步骤包括绕迷走神经放置超尺寸的神经封套。
33.一种植入与迷走神经通信的无导线微刺激器的方法，所述方法包括：
露出迷走神经；
将具有神经封套体的神经封套的缝隙打开，其中所述缝隙沿所述神经封套体的长度打开；
将所述神经封套绕迷走神经放置，从而使神经位于在所述神经封套的长度上延伸的通道内；
将无导线微刺激器插入到所述神经封套的袋部中，从而使所述微刺激器与神经封套内的一个或多个内部的电触点通信；以及
封闭所述神经封套的缝隙，从而使神经与一个或多个内部的电触点电通信。
34.根据权利要求33所述的方法，其中无导线微刺激器和内部的电触点被构造为提供环绕通道内的神经的周向刺激。
35.根据权利要求33所述的方法，其中封闭的步骤包括确保所述神经封套的缝隙封闭。
36.根据权利要求33所述的方法，其中封闭的步骤包括将所述缝隙缝合封闭。
37.根据权利要求33所述的方法，其中放置神经封套的步骤包括绕迷走神经放置超尺寸的神经封套。
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