CN107148294B - 用于试验神经刺激的外部脉冲发生器设备和相关联方法 - Google Patents

用于试验神经刺激的外部脉冲发生器设备和相关联方法 Download PDF

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CN107148294B
CN107148294B CN201580043692.0A CN201580043692A CN107148294B CN 107148294 B CN107148294 B CN 107148294B CN 201580043692 A CN201580043692 A CN 201580043692A CN 107148294 B CN107148294 B CN 107148294B
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pulse generator
lead
patient
external pulse
neurostimulation
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CN107148294A (zh
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P·马瑟
R·萨玛
E·施密德
S·卡滕
D·施罗德
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Exxonix Co ltd
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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
    • A61N1/18—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
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • A61N1/37241—Aspects of the external programmer providing test stimulations
    • 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
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • 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
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
    • 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
    • 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
    • A61N1/36107—Sexual dysfunction
    • 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
    • A61N1/36128—Control systems
    • A61N1/36132—Control systems using patient feedback
    • 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

Abstract

本文中提供了用于向患者提供试验神经刺激以便评估永久性植入神经刺激的适用性的系统和方法。在一方面，试验神经刺激系统包括EPG贴片，所述EPG贴片粘附至患者的皮肤表面并且连接至延伸穿过经皮切口到达目标组织位置的引线。所述EPG可以是所述永久性系统中使用的IPG的修改版本，所述EPG可以比相应的IPG设备更小和/或更轻。可以密封所述EPG和引线延伸部，以便允许改善的患者移动性和降低的感染风险。所述EPG可以与用于控制和监测所述IPG的无线系统相兼容，从而使得对所述EPG的操作和控制在每一个系统中基本上相同，从而允许无缝转换至所述永久性植入式系统。

Description

用于试验神经刺激的外部脉冲发生器设备和相关联方法
相关申请的交叉引用
本申请是于2014年8月15日提交的美国临时申请号62/038,131以及于2014年8月25日提交的美国临时申请号62/041,611的非临时申请并请求其权益，所述申请的全部内容通过引用结合在此。
本申请还涉及以下同时提交的美国非临时专利申请号：题为“Devices andMethods for Anchoring of Neurostimulation Leads(用于锚定神经刺激引线的设备和方法)”的_____[代理人案卷号97672-001011US-947219]；题为“Electromyographic LeadPositioning and Stimulation Titration in a Nerve Stimulation System forTreatment of Overactive Bladder(在用于治疗膀胱过度活动症的神经刺激系统中的肌电图引线定位和刺激滴定)”的_____，[代理人案卷号97672-001211US-947564]；题为“Integrated Electromyographic Clinician Programmer For Use With anImplantable Neurostimulator(用于与可植入神经刺激器一起使用的集成肌电图临床医生程控器)”的_____[代理人案卷号97672-001221US-947566]；以及题为“Systems andMethods for Neurostimulation Electrode Configurations Based on NeuralLocalization(用于基于神经定位来进行神经刺激电极配置的系统和方法)”的_____[代理人案卷号97672-001231US-947224]；以及以下美国临时申请号：于2015年1月9日提交的题为“Patient Remote and Associated Methods of Use With a Nerve StimulationSystem(与神经刺激系统一起使用的患者遥控器和相关联方法)”的62/101,666；于2015年1月9日提交的题为“Attachment Devices and Associated Methods of Use With a NerveStimulation Charging Device(与神经刺激充电设备一起使用的附接设备和相关联方法)”的62/101,884；于2015年1月9日提交的题为“Improved Antenna and Methods of UseFor an Implantable Nerve Stimulator(可植入神经刺激器的改进天线和使用方法)”的62/101,782；以及于2015年7月10日提交的题为“Implantable Nerve Stimulator HavingInternal Electronics Without ASIC and Methods of Use(具有无ASIC的内部电子器件的可植入神经刺激器以及使用方法)”的62/191,134，所述申请中的每一个申请都转让给相同的受让人并出于所有目的通过引用以其全部内容结合在此。
背景技术
近年来，使用植入式神经刺激系统来进行治疗变得越来越普遍。虽然这种系统已经在治疗许多慢性状况方面显示出了前景，但是治疗有效性可能在患者之间明显变化并且在植入之前可能难以确定治疗的可行性。尽管常规的植入方法通常利用使用临时性部分植入式神经刺激系统进行的初步测试来评估治疗的可行性，但是这种系统可能无法提供对使用完全植入式设备来进行的治疗的准确表示。此外，这种系统通常很庞大、令人不舒服并且限制了患者移动性，从而使得许多患者选择不接收临时性系统或完全植入式系统。此外，许多这种临时性部分植入式系统由于脉冲发生器之间的差异或转换期间神经刺激引线的位置改变而可能无法采用与它们的完全植入式对等物相同的方式来进行操作。因此，期望的是，提供用于提供试验治疗系统的方法和设备，相比于完全植入式神经刺激系统，试验治疗系统提供了更准确的治疗表示、改善了患者舒适性、并提供了始终如一的治疗结果。
发明内容
本申请涉及神经刺激治疗系统，并且具体地涉及具有部分植入式神经刺激引线的神经刺激治疗，所述神经刺激引线延伸到外部脉冲发生器以便进行试验神经刺激治疗从而评估完全植入式系统的可行性。在一方面，所述系统包括部分植入式神经刺激引线，所述部分植入式神经刺激引线从一个或多个植入式神经刺激电极延伸到在支撑在附着至患者皮肤上的粘附贴片的外部脉冲发生器(EPG)。在某些实施例中，EPG密封在粘附至患者身体上的分层柔性贴片内以便允许患者参与正常的日常活动，包括淋浴。粘附贴片可以利用具有足够强度以便在试验期的持续时间内维持粘附性的皮肤相容粘附剂。在一些方面，试验期可以短至4至7天，而在其他方面，试验期可以延长两周或更多，通常约四周。系统可以进一步使用附加粘附贴片来密封部分植入式引线延伸所穿过的经皮切口并且维持引线延伸到身体外部的位置并阻止引线的经皮部分的迁移。因为在试验期内可以不将引线的锚定件部分展开，从而允许在试验期内对神经刺激电极进行调节，所以这是有利的。
在一方面，一种神经刺激系统包括：可植入神经刺激引线，所述可植入引线具有布置在引线主体内的一个或多个导体，所述一个或多个导体从所述引线的近端延伸到布置在所述引线的远端处或附近的一个或多个神经刺激电极；EPG，所述EPG可电耦合至所述可植入引线，当所述脉冲发生器与所述可植入引线电耦合时，所述脉冲发生器与所述一个或多个神经刺激电极电耦合，其中，所述脉冲发生器被配置成用于当被植入在目标位置处时生成多个电脉冲以便通过所述一个或多个神经刺激电极来向患者递送神经刺激治疗；以及粘附贴片，所述粘附贴片被适配成用于基本上覆盖所述EPG并粘附至所述患者的皮肤上以便在试验期的持续时间内将所述EPG支撑在所述患者的所述皮肤上，从而评估实施神经刺激治疗的疗效。所述粘附贴片包括柔性分层贴片，其中，所述EPG被密封在所述分层贴片内以便防水。所述粘附贴片包括皮肤相容粘附剂和材料以便适合于在所述试验期的所述持续时间内连续粘附至所述患者皮肤，所述试验期的所述持续时间在任何情况下可以是4天至4周或更多。
在另一方面，所述系统可以包括神经刺激引线延伸部，所述神经刺激引线延伸部在一端处连接至所述可植入神经刺激引线的所述近端并且可与所述EPG耦合。所述可植入神经刺激引线具有适合于植入在完全植入式神经刺激系统内而无需在所述试验期之后从所述目标位置处移除所述远端部分的长度，其中，在所述完全植入式神经刺激系统中，所述可植入脉冲发生器被植入在下背部区域中。所述引线延伸部可以具有足够的长度以便将所述EPG贴片定位在期望位置(如患者的腹部)中。在一方面，所述引线延伸部可以通过连接器而耦合至所述引线的所述近端。连接器可以采用与所述IPG上的接口类似的方式来进行操作，从而使得在转换成永久性系统期间所述引线可以与所述引线延伸部断开连接并且被直接连接至IPG。
在某些方面，所述EPG是所述IPG的修改版本，从而使得它们在向神经刺激脉冲递送电脉冲时采用类似方式进行操作。所述EPG通常比所述可植入脉冲发生器更小和/或更轻，比如，通过移除所述IPG的某些部件，比如，使用电池来替换所述IPG的无线充电线圈和相关联部件，或者利用更轻、更薄的外壳材料，从而使得EPG是一次性的。所述EPG可以被配置成与外部控制设备相兼容，在转换成永久性植入式系统期间，所述外部控制设备与IPG一起用于允许容易的转变。
在另一方面，根据本发明的方面的神经刺激系统包括可植入引线，所述可植入引线具有布置在引线主体内的一个或多个导体，所述一个或多个导体从所述引线的近端延伸到布置在所述引线的远端处或附近的一个或多个神经刺激电极；EPG，所述EPG耦合至可植入引线的所述近端并且密封在粘附至所述患者身体(通常在下腹部区域中)的粘附贴片内。所述EPG被配置成用于生成到所述可植入引线的多个电脉冲；所述脉冲发生器被配置成用于当被植入在目标位置处时生成多个电脉冲以便通过所述一个或多个神经刺激电极来向患者递送神经刺激治疗；并且锚定件与恰好在电极近端的所述引线主体耦合。
在一方面，本发明包括具有沿着锚定主体布置的多个尖齿的锚定主体。所述多个尖齿被偏置朝向展开位置，在所述展开位置，尖齿从锚定件主体处横向地向外延伸，以便与组织充分接合从而抑制植入式引线的轴向位移。尖齿被构造成在植入期间可朝着螺旋体弹性地偏转以便在受递送护套约束时朝着螺旋锚定体向内折叠从而促进在植入期间递送至目标位置。通常，在试验期内，护套被布置在所述多个尖齿之上，并且神经刺激引线的位置通过附加粘附贴片来维持，所述附加粘附贴片覆盖延伸到身体外部到达EPG贴片的引线部分。这允许在试验期间根据需要变更引线位置从而确定最适合于治疗的引线位置。如果试验证明成功，则可以抽出外护套并且将尖齿展开以便将引线锚定在位，在这之后，可以将引线连同IPG一起完全植入。本文中还提供了提供使用这种设备来进行的试验治疗的方法。
本公开的进一步适用领域将根据下文所提供的详细说明而变得明显。应当理解的是，虽然详细说明和具体示例指示了各种实施例，但它们仅旨在用于说明目的而并非旨在必定限制本公开的范围。
附图说明
图1是根据本发明的各方面的具有部分植入式引线的试验神经刺激系统的示意图，所述部分植入式引线延伸至粘附到患者的皮肤上的EPG贴片。
图2是图1的神经刺激系统的概况。
图3是根据本发明的各方面的试验神经刺激系统的替代性配置。
图4是根据本发明的各方面的试验神经刺激系统的又另一个替代性配置。
图5是图3中的神经刺激系统的细节。
图6是根据本发明的各方面的示例EPG贴片的顶视图和侧视图。
图7A和图7B展示了根据本发明的各方面的示例EPG贴片。
图7C是根据本发明的各方面的示例EPG贴片的分解视图说明。
图8示意性地展示了根据本发明的各方面的对利用EPG贴片的试验神经刺激系统的使用。
图9和图10展示了根据本发明的各方面的执行试验神经刺激治疗的方法。
具体实施方式
许多年来一直使用神经刺激来治疗各种各样的状况，从慢性疼痛到勃起功能障碍和各种泌尿功能障碍。虽然已经在许多应用中证明神经刺激有效，但是有效的治疗通常取决于使用脉冲发生器、通过一个或多个神经刺激电极来向患者神经或目标区域一致地递送治疗激活。近年来，完全可植入神经刺激变得越来越普遍。尽管这种可植入系统向患者提供了更大的自由度和移动性，但是一旦植入了这种系统的神经刺激电极，就更加难以对其进行调节。通常在可植入引线的通过患者组织中形成的隧道前进的远端上提供神经刺激电极。
图1示意性地展示了根据本发明的各方面的对利用EPG贴片的试验神经刺激系统的使用。这种试验神经刺激系统可以用于评估可完全植入神经刺激系统的可行性。可植入神经刺激系统可以用于对患有例如源自周围神经的慢性、严重、难治的神经病理性疼痛或各种泌尿功能障碍和肠功能障碍的患者进行治疗。可植入神经刺激系统可以用于刺激目标周围神经或脊柱的后硬膜外空间。可植入神经刺激系统包括植入脉冲发生器，通常植入在后背部区域中。在一些实施例中，脉冲发生器可以生成一个或多个向神经递送的以便控制疼痛或引起一些其他期望效果的一个或多个非消融性电脉冲。在一些应用中，可以使用脉冲振幅在0mA与1,000mA之间、0mA与100mA之间、0mA与50mA之间、0mA与25mA之间、和/或任何其他或中间振幅范围内的脉冲。脉冲发生器中的一个或多个脉冲发生器可以包括被适配成用于向可植入神经刺激系统的其他部件提供指令并从其中接收信息的处理器和/或存储器。处理器可以包括如来自
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等的微处理器等微处理器。可植入脉冲发生器可以实施能量存储特征，比如，一个或多个电容器或电池，并且通常包括无线充电单元。
脉冲发生器生成的电脉冲经由在远端处或附近包括一个或多个神经刺激电极的一根或多根引线而被递送至一条或多条神经和/或至目标位置。引线可以具有各种各样的形状、可以是各种各样的大小、并且可由各种各样的材料制成，所述大小、形状和材料可由应用或其他因素决定。在一些应用中，如在图1中所示出的，如在骶神经刺激中，引线可以被植入成沿着脊椎延伸或延伸穿过骶骨的孔之一。在其他应用中，引线可以被植入在患者身体的外围部分中，比如，在手臂或腿中，并且可以被配置成用于向周围神经递送一个或多个电脉冲，比如，可以用于减轻慢性疼痛。
电脉冲的一个或多个特性可以经由植入脉冲发生器的控制器来进行控制。在一些实施例中，这些特性可以包括例如电脉冲的频率、强度、模式、持续时间或其他定时和幅度方面。这些特性可以包括例如电压、电流等。对电脉冲的这种控制可以包括创建一个或多个电脉冲程序、计划或模式，并且在一些实施例中，这可以包括选择一个或多个已有的电脉冲程序、计划或模式。在图1中所描绘的实施例中，可植入神经刺激系统100包括可植入脉冲发生器中具有一个或多个脉冲程序、计划或模式和/或用于选择所创建的脉冲程序、计划或模式中的一项或多项的控制器。
骶神经调节(SNM)(也被称为骶神经刺激(SNS))被定义为对永久设备的植入，所述永久设备对控制膀胱功能或直肠功能的神经路径进行调节。这种策略解决了在对膀胱和/或直肠具有完整神经支配的患者体内使用SNM来治疗尿失禁或大便失禁、非阻塞性尿潴留或非阻塞性大便潴留、或者慢性骨盆疼痛。
使用SNM(也被称为SNS)来进行的治疗是用于行为治疗(提示排泄)和/或药理学治疗失败的患有大便失禁或尿失禁(急迫性尿失禁、显著尿急-尿频症状、或非阻塞性尿潴留)的患者的若干替代性形式之一。急迫性尿失禁被定义为当存在强烈排泄欲望时的漏尿。尿急-尿频是不可控制的排尿欲望，导致非常频繁且小的排尿量，并且是间质性膀胱炎(也被称为膀胱疼痛综合征)的明显症状。尿潴留是无法将尿液从膀胱中完全排出。大便失禁可能由各种各样的机制产生，包括直肠壁顺应性、神经路径、神经系统、和随意肌和不随意肌。失禁对于女性更加常见，通常与可能在阴道分娩期间发生的肌肉和神经损伤相关联。
SNM设备由递送受控电脉冲的可植入脉冲发神器组成。脉冲发生器附接至引线，所述引线连接至骶神经(最常见地，S3神经根)。系统的两个外部部件帮助控制电刺激。患者遥控器由患者保留并且可以用于接通或断开设备或者用于调节刺激强度。控制台程控器由医生保留并且用于调节脉冲发生器的设置。
在常规方法中，在植入永久设备之前，患者经受初始测试阶段，以便估计对治疗的潜在反应。开发的第一种类型的测试是经皮神经评估(PNE)。此过程在局部麻醉下进行，使用测试针来标识(多个)适当的骶神经。一旦被标识，就通过测试针来插入临时性引线并将其保留在位4至7天。此引线连接至外部刺激器，所述外部刺激器由患者携带在他们的口袋中或在他们的腰带上。此测试阶段的结果用于判定患者是否是永久设备的适当人选。例如，对于膀胱过度活动症，如果患者展现出50％或更多的症状频率降低，那么他们被视为符合永久设备的条件。
第二种类型的测试是2阶段手术程序。在第1阶段中，植入了四极尖齿形引线(第1阶段)。测试阶段可以持续长达若干周，并且如果患者展现出了特定的症状频率降低，则他们可以继续治疗的第2阶段，所述阶段是对神经刺激设备的永久植入。已经采用各种方式来使用2阶段手术程序。这些方式包括：对于PNE失败的患者、对于无PNE结论的患者、或者对于PNE成功的患者，将所述程序(而不是PNE)用于进一步改善患者选择。
永久设备在局部麻醉或全身麻醉下植入。在下背之上形成切口，并且电引线被放置为与(多个)骶神经根接触。引线在皮肤下面延伸到袋状切口，在所述袋状切口处，插入脉冲发生器并将其连接至引线。在植入之后，医生将脉冲发生器编程为针对该患者的最优设置。
在膀胱功能异常的实例中，对于满足以下标准中的所有标准的患者，使用经皮神经刺激或临时性植入式引线来进行的骶神经调节的试验期被认为是医学必要的(至少出于保险覆盖范围的目的)：(1)诊断为以下各项中的至少一项：急迫性尿失禁、尿急-尿频综合征、非阻塞性尿潴留、和膀胱过度活动症；(2)存在经记录的对至少两种常规治疗(例如，如膀胱训练、提示排泄或盆腔肌肉训练等行为训练；药理学治疗至少足够的持续时间以便充分评估其疗效；和/或手术矫正治疗)的失败或不耐性；(3)患者是适当的手术人选；以及(4)失禁与神经病学状况无关。
对于满足以下标准中的所有标准的患者，对骶神经调节设备的永久植入被认为是医学必要的：(1)满足上一段落中的标准(1)至(4)中的所有标准；以及(2)试验刺激期在至少一周的期间内展示出至少50％的症状改善。
骶神经调节的其他泌尿/排泄应用需要进一步研究，包括但不限于对由于神经病学状况(例如，逼尿肌反射亢进、多发性硬化、脊髓损伤、或其他类型的慢性排泄功能障碍)而引起的压力性尿失禁或急迫性尿失禁的治疗。(见蓝十字与蓝盾协会(Blue Cross BlueShield)提供的对骶神经调节/刺激覆盖范围的策略描述，所述策略描述可从http://www.bcbsms.com/com/bcbsms/apps/PolicySearch/views/ViewPolicy.php？&noprint＝yes&path＝％2Fpolicy％2Femed％2FSacral_Nerve_Stimulation.html在线获得)
研究表明针对第1阶段的试验转换率(患者将试验系统转换成永久性植入式系统的比率)比针对PNE的试验转换率更高。例如，一项研究发现PNE试验导致40-50％的试验转换率，而第1阶段试验导致70-90％的转换，表明第1阶段通常提供对治疗有效性的更好指示。(见1巴斯特和金姆(Baster and Kim)(2010)，最新泌尿学报告(Curr urol Rep))。
在另一种常规方法中，在周围神经刺激(PNS)治疗系统中使用类似方法。通常，对周围神经刺激的人选进行评估，以便确定他们对于经受PNS程序的适用性。在手术之前，患者将经受手术前测试，所述手术前测试包括血常规检查和神经心理学评估。通常以两个单独的阶段执行PNS程序本身。每一个阶段耗费约一小时，并且患者可以当天回家。
在这个方面，第1阶段涉及经由小针来植入试验电极，所述试验电极连接至通常穿戴在患者的腰带上的外部脉冲发生器(EPG)。在接下来的几天内提供许多刺激程序。如果此试验显示出显著的患者头痛或面部疼痛改善，则可以发生永久植入。在第2阶段中，宽度为天使面(Angel-Hair Pasta)的一组新电极被植入在皮肤下。这些电极被连接至植入在胸部、腹部或后背中皮肤下的更小的可植入脉冲发生器。
与这些常规方法相关联的缺点是与以下各项相关联的不适：穿戴EPG、感染风险、以及与在第2阶段中对植入测试引线的移除和对永久引线的植入相关联的附加程序。此外，所提供的EPG通常不同于最终植入的IPG。假如治疗疗效通常取决于神经刺激电极在目标组织位置处的精确放置和使用设备来进行的对神经刺激治疗的一致、重复递送，则试验期(比如，在PNE和第1阶段试验期内)的有效性不总指示使用永久性植入式系统来进行的有效治疗。在一方面，因为在试验期内的治疗的有效性可能部分地取决于患者的主观体验，所以如果可以将患者穿戴EPG的不适和不方便最小化，从而使得患者可以恢复正常的日常活动而不会经常意识到EPG和治疗系统的存在，则这是期望的。此方面可能对于尿急-尿频、膀胱过度活动症和勃起功能障碍的治疗尤其重要，在这之中，患者对设备的意识可能妨碍患者对与这些状况相关联的症状的体验。
在一方面，本发明允许通过提供具有改善的患者舒适性的试验系统来对试验期内的疗效进行改进评估，从而使得患者可以更容易地意识到治疗的益处和有效性。在另一方面，试验系统通过在永久性系统中利用与在试验系统中用于递送治疗的植入神经刺激引线相同的植入神经刺激引线来递送治疗从而提供对治疗的有效性的更好指示并且进一步降低与将试验系统转换成永久性系统相关联的创伤。在另一方面，EPG递送治疗的部分与永久性系统中的IPG基本上相同，从而使得永久治疗的效果应当与在试验系统中所看到的效果更一致。
在某些实施例中，本发明提供了穿戴在患者的皮肤上以便改善患者舒适性的EPG贴片。可选地，在第1阶段中使用的EPG可以比在相应第2阶段中使用的IPG更小，从而使得EPG可以容易地被覆盖EPG的粘附贴片支撑并由粘附贴片将其密封免受污染。在一方面，EPG是在第2阶段中使用的可植入IPG的修改版本。可以通过移除一个或多个部件(比如，使用更小的电池和相关联部件来移除远端充电线圈)来修改IPG。此外，因为EPG不需要持续如IPG将持续的许多年，所以EPG可以使用比IPG更薄、更轻的外壳。因此，EPG可以被配置成是一次性的。这些方面允许根据期望而将EPG支撑在穿戴在患者的皮肤上方便的位置处(比如，在腹部上或患者身体侧面)的贴片内。
图1展示了具有EPG贴片10的示例试验神经刺激系统100。如所示出的，神经刺激系统被适配成用于刺激腹部骶神经根。神经刺激系统100包括植入在下背部区域中的可植入脉冲发生器(IPG)，神经刺激引线20从可植入脉冲发生器延伸穿过骶骨的孔到达布置在腹部骶神经根附近的电极(未示出)。神经刺激引线20进一步包括布置在骶骨背侧的锚定件10。然而，应当理解的是，锚定件也可以布置在骶骨的腹侧，或在孔本身内。在一方面，EPG40是一次性的并且可以在完成试验之后丢弃。通常，试验可以在任何情况下持续4天至8周。通常，可以在4至7天后获得初始评估，并且如果需要，可以在几周(通常，约4周)之后检查治疗的有效性。在一方面，EPG贴片10的EPG 40具有与将在试验证明成功的情况下植入的IPG基本上类似的设计，除了将一个或多个部件移除以便允许EPG的大小更小和/或由于设备可能旨在用于一次性用途而使用不同材料以外。
图2更加详细地展示了与图1中的神经刺激系统类似的神经刺激系统100。如可以看到的，神经刺激引线20包括在引线的远端处的多个神经刺激电极30以及具有恰好布置在电极30的近端的多个尖齿的锚定件50。通常，锚定件被布置在所述多个电极的附近和近端，以便提供将引线锚定成相对靠近电极。当EPG 40附接至患者的皮肤上时，EPG 40被支撑在粘附贴片12内。在一方面，在试验期内使用的EPG 40比将植入在永久性系统中的相应IPG更小。通过将试验期内或对于外部设备可能不必要的部件(例如，无线充电线圈和相关联部件)移除来使这成为可能。EPG 40可以利用由此允许设备更小和更轻的电池，以便允许由粘附贴片支撑以及由患者在最低不适的情况下穿戴EPG。
在一方面，附加粘附贴片16可以用于覆盖和密封患者的皮肤内的经皮切口，神经刺激引线的经皮部分通过所述经皮切口插入。可以使用医用胶布17来将引线固定在经皮切口处，并且可以使用覆盖引线和经皮切口的粘附贴片来进一步固定和密封所述引线。以此方式，可以密封和保护经皮切口免受污染或感染，并且可以通过附加粘附贴片16来维持其位置。这种配置降低了感染的可能性并阻止引线的运动(内部和外部运动两者)，从而使得将患者对贴片和引线的意识最小化，由此允许患者恢复相对正常的日常活动。
在另一方面，因为可以将EPG贴片穿戴在与IPG将被植入的位置不同的位置中(比如，在腹部上)，以便允许IPG使用神经刺激引线20的相同经皮部分，所以系统可以使用通过外部连接器21与引线20耦合的引线延伸部22。引线延伸部22可以被硬连线连接到EPG中，以便消除潜在断开连接并允许将连接密封或包封在粘附贴片内从而是防水的或不透水的。这允许患者在不移除设备的情况下执行常规的日常活动(比如，淋浴)。引线20的长度可以是适合于永久性植入式系统的长度，而延伸部22的长度允许将到EPG贴片的引线定位在提供改善的舒适性和对日常活动的最小干扰的位置中。
图3展示了替代性配置，在所述替代性配置中，引线足够长以便允许EPG贴片10粘附至患者的腹部。因为这种放置允许患者更多的移动性和自由度以便恢复日常活动并且不妨碍坐或睡觉，所以这种配置是有利的。可以通过如通过图3中的中央贴片所示出的附加粘附贴片16来固定多余的引线。在一方面，引线被硬连接至EPG，而在另一方面，引线通过柔性贴片12的顶表面中的端口或孔口被可移动地连接至EPG。在一方面，EPG贴片可布置成使得在不将引线的远端移动远离目标位置的情况下可以断开引线连接并在永久性植入式系统中使用所述引线。在另一方面，整个系统可以是一次性的并且可以使用引线和IPG来进行替换。
在一方面，可以通过患者遥控器、采用与永久性植入式系统的IPG相似或完全相同的方式来无线地控制EPG单元。医生或患者可以通过使用便携式临床医生单元来改变EPG所提供的治疗，并且所递送的治疗被记录在设备的存储器上，以供用于确定适合于在永久性植入式系统中使用的治疗。
图4展示了替代性配置，在所述替代性配置中，引线20通过连接器21连接至引线延伸部21。这允许延伸引线，从而使得EPG贴片可以放置在腹部上。这还允许使用长度适合于植入在永久性系统中的引线20。此方法可以利用两个经皮切口，在第一切口中提供连接器21并且引线延伸部12延伸穿过第二经皮切口，在其之间存在短的穿隧距离(约10cm)。在将实验系统转换为永久性植入式系统期间，这种方法使植入式引线20的移动最小化。在转换期间，可以将引线延伸部22连同连接器21和附接至IPG的植入式引线20移除，所述IPG被永久地植入在第一经皮切口的位点处或附近的位置中。在一方面，连接器21可以包括设计与IPG上的连接器的设计类似的连接器。这允许通过连接器21来将引线20的近端耦合至引线延伸部22并且在转换成永久性植入式系统期间将所述近端容易地与IPG分离和耦合。
图5展示了粘附至患者的皮肤的EPG贴片的详细试图，附加粘附贴片16被布置在经皮切口之上，引线通过所述经皮切口延伸到患者体内，并且另一个附加贴片16覆盖一圈多余引线，所述贴片与第一附加贴片和EPG贴片10的边缘重叠。因为这种配置基本上覆盖并密封EPG和引线免受污染并阻止患者进行的对引线的突然断开连接或迁移，并且简化了系统的外部部分以便改善患者舒适性并允许患者的主观体验与患者将在永久性植入式系统中体验的东西更紧密地匹配，所以这种配置是有利的。
图6展示了EPG贴片10的顶视图和侧视图。在一方面，EPG比相应可完全植入永久性系统中的IPG更小。在某些实施例中，粘附贴片12的外部宽度(w2)在2与5英寸之间(优选地，约2.5英寸)，而贴片12的外部宽度(l2)在3与6英寸之间(优选地，约4英寸)；EPG的宽度(w1)在0.5与2英寸之间(优选地，约1英寸)，而长度(l1)在1与3英寸之间(优选地，约2英寸)；并且整个EPG贴片10的厚度(t)小于1英寸(优选地，0.8英寸或更少)。这种设计远小于常规系统中的EPG并且因此在试验期内更少地妨碍患者的日常活动。
图7A和图7B展示了两个EPG贴片10的透视图。在图7A中，柔性分层贴片12的顶表面提供对包裹在贴片内的EPG的连接端口42的接入。所述贴片可以进一步包括具有模制的触觉细部的用于允许患者通过粘附贴片12的外表面来接通和断开EPG的“开/关”按钮44。贴片12的分层表面还可以部分地透射光，从而使得LED“接通”指示可以通过贴片可见(可以在开/关按钮44右方看到LED光的辉光)。贴片14的下侧覆盖有皮肤相容粘附剂。粘附剂表面可以被配置有适合于在试验期的方向内连续粘附至患者身体上的任何粘附剂或粘附材料。例如，具有皮肤相容粘附剂的透气性条带将允许贴片12保持连续附接至患者超过一周(通常两周到四周)或甚至更长的时间。在图7B中，EPG贴片的EPG被硬连线连接至引线延伸部22。这允许将整个引线延伸部22和EPG密封，由此提高系统的防水性。与以上所描述的EPG贴片10的实施例相关联的优点包括：可处置性；增大的患者移动性，包括淋浴的能力；改善的患者舒适性；更低的感染风险；以及需要更少穿过组织的穿隧。这些方面增大了试验期成功的可能性以及患者将从实验系统转换成永久性植入式系统的可能性。
图7C是示例EPG贴片300的示例的分解视图说明。如所展示的，EPG贴片300可以包括贴片306的顶表面以及贴片314的底表面，所述顶表面和所述底表面可以结合在一起以便包裹EPG 304。贴片306的顶表面和贴片314的底表面中的任一者或两者可以是可替换且可移除的，从而使得两个部件彼此可移除地绑定。贴片314的底表面可以进一步包括剥离衬底。EPG 304可由形成壳体的薄塑料外壳构造，具有EPG壳体顶部316和EPG壳体底部318。一个或多个主电池320可以包含在EPG 304的壳体内，所述一个或多个主电池可以单独地或组合地提供用于对EPG 304的操作的足够电力约14个使用天数。进一步地，EPG 304可以包括用于生成脉冲和进行其他功能的内部电路322。
图8展示了根据本发明的方面的试验系统100以及永久性系统200的示意图。如可以看到的，对于与无线临床医生程控器和患者遥控器一起使用，试验系统和永久性系统中的每一者都是兼容的。在试验系统和永久性系统中的每一者中，临床医生程控器可以用于引线放置、编程和/或刺激控制。此外，每一个系统允许患者使用患者遥控器来控制刺激或监测电池状态。由于这种配置允许试验系统与永久性系统之间的几乎无缝转换，所以其是有利的。从患者的角度来看，系统将以相同的方式进行操作并且将以相同的方式来控制所述系统，从而使得患者使用试验系统的主观体验与将在使用永久性植入式系统时体验的东西更紧密地匹配。由此，这种配置减小了患者可能具有的关于系统将如何进行操作和如何对其进行控制的任何不确定性，从而使得患者将更有可能将实验系统转换成永久性系统。
图9和图10展示了根据本发明的方面的可以使用EPG贴片来进行治疗的方法。图9的方法包括以下步骤：使神经刺激引线前进至患者体内的目标位置，将引线电连接至EPG并通过将支撑EPG的粘附贴片粘附至患者的皮肤表面(或者可选地将EPG固定至患者穿戴的腰带)来固定EPG以便进行试验治疗；在试验治疗时使用EPG来执行一次或多次神经刺激治疗以便评估在患者体内进行治疗的可行性；移除所植入的试验引线并使用永久性植入式引线来替换它，并且将永久性引线连接至IPG并将神经刺激引线和IPG完全植入在患者体内；以及基于利用EPG进行的试验治疗使用完全植入式系统和IPG来执行治疗。
图10的方法包括以下步骤：使神经刺激引线的远端前进至患者体内的目标位置，通过引线延伸部将引线电连接至EPG并通过将支撑EPG的粘附贴片粘附至患者皮肤的皮肤表面(或者可选地将EPG固定至患者穿戴的腰带)来固定EPG以便进行受限持续时间的试验治疗；使用部分植入式引线和附接EPG来执行一次或多次神经刺激治疗，以便评估在患者体内进行治疗的可行性；在不移除引线的植入在目标位置处的远端的情况下移除引线延伸部并将神经刺激引线与IPG电耦合，并将引线和IPG完全植入在患者体内；以及基于利用EPG进行的试验治疗使用完全植入式引线和附接IPG来执行治疗。
在前述说明书中，参照其特定实施例描述了本发明，但是本领域的技术人员将会认识到，本发明并不局限于此。上述发明的不同特征和方面可以单独使用或者共同使用。此外，在不脱离本说明书的更广泛的精神和范围的情况下，可以在超出本文中所描述的环境和应用的任何数量的环境和应用中利用本发明。因此，本说明书和附图应被视为说明性的而不是限制性的。将认识到，如本文中所使用的术语“包括(comprising)”、“包括(including)”以及“具有”具体旨在被理解为本领域的开放性术语。

Claims (12)

1.一种神经刺激系统，包括：
可植入神经刺激引线，所述可植入神经刺激引线具有布置在引线主体内的一个或多个导体，所述一个或多个导体从所述引线的近端延伸到布置在所述引线的远端处或附近的一个或多个神经刺激电极；
外部脉冲发生器，所述外部脉冲发生器可电耦合至所述可植入引线，当所述外部脉冲发生器与所述可植入引线电耦合时，所述外部脉冲发生器与所述一个或多个神经刺激电极电耦合，其中，所述外部脉冲发生器被配置成用于当被植入在目标位置处时生成多个电脉冲以便通过所述一个或多个神经刺激电极来向患者递送神经刺激治疗；以及
可植入脉冲发生器，所述可植入脉冲发生器被适配成用于通过所述可植入神经刺激引线来递送所述神经刺激治疗；
其中所述外部脉冲发生器包括单个按钮，所述单个按钮被配置成用于接通所述外部脉冲发生器以便递送试验神经刺激治疗，且其中所述外部脉冲发生器的外壳上没有设置手动刺激调节控件，所述外部脉冲发生器被配置为与患者遥控器无线地耦合以便由所述患者对刺激进行调节；并且
其中所述可植入脉冲发生器包括用于当所述可植入脉冲发生器被植入时通过所述患者的皮肤来进行无线充电的线圈和相关联部件，并且其中所述外部脉冲发生器与所述可植入脉冲发生器之间的差异包括所述外部脉冲发生器省略用于进行无线充电的所述线圈和相关联部件并且包括电池电源以使得所述外部脉冲发生器更轻以允许所述外部脉冲发生器由粘附贴片或带支撑以及由患者在最低不适的情况下穿戴，其中所述外部脉冲发生器的电池电源不可充电并且不可由用户拆卸。
2.如权利要求1所述的系统，进一步包括粘附贴片，所述粘附贴片被适配成用于基本上覆盖所述外部脉冲发生器并粘附到所述患者的皮肤上以便在试验期的持续时间内将所述外部脉冲发生器支撑在所述患者的所述皮肤上，以便评估所述神经刺激治疗的疗效。
3.如权利要求2所述的系统，其中，所述粘附贴片包括柔性分层贴片，其中，所述外部脉冲发生器被密封在所述分层贴片内以便防水。
4.如权利要求2所述的系统，其中，所述粘附贴片包括具有足够粘附强度以便在所述试验期的所述持续时间内将所述外部脉冲发生器连续地支撑在所述患者的所述皮肤上的一层皮肤相容粘附剂和/或透气胶带。
5.如权利要求4所述的系统，其中，所述试验期的所述持续时间是至少一周。
6.如权利要求1所述的系统，进一步包括神经刺激引线延伸部，所述神经刺激引线延伸部在一端处可连接至所述可植入神经刺激引线的所述近端并且可在相反的端处与所述外部脉冲发生器耦合。
7.如权利要求6所述的系统，其中，所述引线延伸部在可移除连接器处连接至所述神经刺激引线的所述近端，所述引线延伸部具有足够的长度以便当所述远端被定位在所述目标位置处时将所述外部脉冲发生器支撑在所述患者身体上的期望位置处。
8.如权利要求7所述的系统，其中，所述引线延伸部可与所述外部脉冲发生器可移除地耦合。
9.如权利要求7所述的系统，其中，所述引线延伸部与所述外部脉冲发生器硬连线连接。
10.如权利要求1所述的系统，其中，所述可植入脉冲发生器被配置成用于当被植入时运行一年或多年，而所述外部脉冲发生器被配置成是一次性的。
11.如权利要求1所述的系统，其中，所述外部脉冲发生器包括设置在其上的开/关按钮以允许所述患者手动地接通以及断开所述外部脉冲发生器。
12.如权利要求1所述的系统，进一步包括为植入而配置的可植入脉冲发生器，其中所述可植入脉冲发生器可与所述患者遥控器无线地耦合并且适配成以与所述外部脉冲发生器相同的方式经由所述遥控器对刺激实行调节。
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