CN112657054A - 用于进行神经刺激以减轻膀胱功能障碍和其他适应症的可植入引线附着结构 - Google Patents
用于进行神经刺激以减轻膀胱功能障碍和其他适应症的可植入引线附着结构 Download PDFInfo
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- CN112657054A CN112657054A CN202011496654.XA CN202011496654A CN112657054A CN 112657054 A CN112657054 A CN 112657054A CN 202011496654 A CN202011496654 A CN 202011496654A CN 112657054 A CN112657054 A CN 112657054A
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Abstract
本文中提供了用于将神经刺激***的植入式引线附着在患者体内的目标位置处的锚定设备和方法。这种锚定设备包括螺旋主体,所述螺旋主体具有当被展开时从所述引线横向地向外延伸的多个尖齿,所述多个尖齿与组织接合以便抑制所述植入式引线的轴向运动。所述多个尖齿被偏置朝向所述横向延伸的展开构型并且朝向所述引线向内折叠成递送构型以便促进通过护套来递送所述引线。所述尖齿可以在近端方向上或者在近端方向和远端方向两者上成一定角度并且可以包括用于辅助对所述引线的可视化和递送的各种特征。所述锚定件可以根据各种方法形成,包括对管状区段的激光切割连同用于将材料与所述锚定件一起定形为所述展开构型的加热和回流、以及注塑成型。
Description
本申请是申请日为2015年08月14日、申请号为201580043876.7、题 为“用于进行神经刺激以减轻膀胱功能障碍和其他适应症的可植入引线附 着结构”的分案申请。
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62/038,122 以及于2015年1月30日提交的美国临时申请号62/110,274的非临时申请并请 求其权益,所述申请中的每一个申请通过引用以其文结合在此。
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 “External PulseGenerator Device and Associated Methods for Trial Nerve Stimulation(用于试验神经刺激的外部脉冲发生器设备和相关联方法)”的 _____[代理人案卷号97672-001110US-947226];题为“Electromyographic Lead Positioning and StimulationTitration in a Nerve Stimulation System for Treatment of Overactive Bladder(在用于治疗膀胱过度活动症的神经刺激***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“IntegratedElectromyographic Clinician Programmer For Use With an ImplantableNeurostimulator(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 and Methods forNeurostimulation Electrode Configurations Based on Neural Localization(用于基于神经定位来进行神经刺激电极配置的***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“PatientRemote and Associated Methods of Use With a Nerve Stimulation System(与神经刺激***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 Nerve StimulationCharging 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 Use For anImplantable 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。
技术领域
本发明涉及神经刺激治疗***和相关联的设备;以及这种治疗*** 的治疗、植入和配置方法。
背景技术
近年来,使用可植入神经刺激***来进行治疗已经变得越来越普 遍。虽然这种***已经在治疗许多病情方面显示出了前景,但是治疗有效性可 能在患者之间明显变化。许多因素可能导致患者经历非常不同的疗效,并且 在植入之前可能难以确定治疗的可行性。例如,刺激***通常利用电极阵列来 治疗一个或多个目标神经结构。电极通常一起安装在多电极引线上,并且所述 引线在患者的组织中被植入在旨在引起电极与目标神经结构的电耦合的位置 处,通常经由中间组织来提供耦合的至少一部分。也可以采用其他方式,例如, 一个或多个电极附接至覆盖目标神经结构的皮肤上、植入在目标神经周围的袖 口中等等。无论如何,内科医生将通常试图通过改变应用到电极上的电刺激来 建立适当的治疗方案。
当前刺激电极放置/植入技术和众所周知的治疗设置技术具有显著 的缺点。不同患者的神经组织结构可能大不相同,准确地预测或标识执行特定 功能和/或衰弱特定器官的神经的位置和分支是一种挑战。在不同的患者当中, 围绕目标神经结构的组织结构的电特性也可能大不相同,并且对刺激的神经反 应可能随着有效影响一位患者的身体功能并且潜在地向另一位患者施加显著 不适或疼痛或对所述另一位患者具有有限效果的电刺激脉冲模式、脉冲宽度、 频率、和/或振幅而明显不同。甚至在对神经刺激***的植入提供有效治疗的患 者体内,在可以确定适当的治疗程序之前,经常需要频繁地调节和改变刺激方案,经常涉及在实现效果之前患者的重复就诊和显著不适。虽然已经实施了许 多复杂且成熟的引线结构和刺激设置方案来试图克服这些挑担,但是引线放置 结果的可变性、用于建立适当刺激信号的临床医生时间、以及施加给患者的不 适(以及在某些情况下,显著疼痛)仍然不太理想。此外,这种设备的使用期 和电池寿命相对短,从而使得每隔几年对植入的***进行常规替换,这需要附 加手术、患者不适、以及医疗***的显著费用。
此外,因为神经结构的形态在患者之间明显变化,所以可能难以控 制神经刺激引线相对于目标神经结构的放置和对准,这可能导致不一致的放 置、不可预测的结果以及非常不同的患者疗效。出于这些原因,神经刺激引线 通常包括多个电极,以期至少一个电极或一对电极将被布置在适合于递送神经 刺激的位置中。这种方式的一个缺点是可能需要重复就诊来确定要使用的适当 电极和/或来达成递送有效治疗的神经刺激程序。通常,可用神经刺激程序的数 量可能受限于不精确的引线放置。
仍未完全实现这些神经刺激治疗的巨大效益。因此,期望的是提供 改进的神经刺激方法、***和设备,以及用于为所治疗的特定患者或病情植入 这种神经刺激***的方法。将特别有帮助的是,提供这种***和方法,以便提 高医生在定位和附着这种引线方面的易用性,以便确保在植入之后维持适当的 引线放置,从而在递送神经刺激治疗之后提供一致且可预测的结果。因此,期 望的是,提供用于植入神经刺激引线的在植入期间改进对引线的锚定并允许减 小的引线递送轮廓的方法和设备。
发明内容
本申请涉及可植入神经刺激***,并且具体涉及用于锚定植入神经 刺激引线的设备和方法。在一方面,本发明包括绕引线螺旋状地延伸的锚定主 体以及沿着锚定主体布置的多个尖齿。所述多个尖齿偏置朝向展开位置,在展 开位置中,尖齿从螺旋主体处横向地向外延伸,以便充分地与组织接合从而抑 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主体弹性地偏 转以便在受递送护套约束时朝着螺旋锚定主体向内折叠从而促进在植入期间 递送至目标位置。
在一方面,根据本发明的方面的神经刺激***包括可植入引线,所 述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;脉冲发生器,所述脉冲发生器可耦合至所述可植入引线的所述近端, 当所述脉冲发生器耦合至所述可植入引线时,所述脉冲发生器与所述一个或多 个神经刺激电极电耦合,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;以及锚定件,所述锚定件与恰好在所述电极近端的所述引线主体耦合。
在一方面,锚定件包括在引线主体外部沿着其纵向轴线螺旋状地延 伸的螺旋主体以及横向地延伸远离螺旋主体的多个尖齿。所述多个尖齿中的每 一个尖齿被偏置朝向展开构型和递送构型。在展开构型中,所述多个尖齿横向 地延伸远离纵向轴线(当螺旋主体布置在其上时),并且在递送构型中,所述 多个尖齿朝向引线主体的纵向轴线向内折叠以便促进在植入期间递送神经刺 激引线。在某些实施例中,锚定件被配置成使得在递送构型中,所述多个尖齿 中的每一个尖齿都折叠抵靠引线主体,以便进一步减小递送轮廓,在递送构型 中,锚定件具有与直径为5Fr(French)或更大的护套相兼容的横截面轮廓或 横断轮廓。在某些实施例中,所述螺旋主体和所述多个尖齿由相同的材料整体 形成,而在其他实施例中,尖齿可以是附接至螺旋主体的单独元件。所述尖齿 由具有足够刚度的材料形成,从而使得,当所述尖齿被植入在所述患者的组织 内所述目标位置处时,组织与所述多个尖齿的接合抑制引线的轴向运动。在一 些实施例中,锚定件可由肖氏硬度在50A与80D之间的范围内的基于聚氨酯 的材料模制而成。在其他实施例中,锚定件可由如形状记忆合金等金属形成。 在仍其他实施例中,锚定件可由如基于聚合物的材料和金属(比如,形状记忆合金线)等材料的组合形成。
在某些实施例中,锚定件的尺寸被设定成使得当螺旋主体耦合在引 线主体上时螺旋主体沿着引线主体延伸10mm与30mm之间的长度,优选地, 约20mm。所述多个尖齿中的每一个尖齿可以从纵向轴线横向地向外延伸1 mm与4mm之间的距离。所述多个尖齿中的每一个尖齿的长度可以在1.5mm 与3mm之间并且宽度可以在0.5mm与2.0mm之间。在一些实施例中,所述 多个尖齿包括在近端方向上具有变化长度、宽度和角度的尖齿,而在其他实施例中,所述多个尖齿可以具有不同的长度或者可以在近端方向和远端方向两者 上成一定角度。所述多个尖齿可以具有基本上矩形的标签形状,并且可以包括 倒圆或倒角的角和/或边缘,以便抑制在角和/或边缘处的组织损伤。在一些实 施例中,尖齿在展开构型中被偏置朝向与纵向轴线成30与80度之间的角度。
在一方面,螺旋主体附接至引线主体具有凹陷部分的锚定部分中, 所述凹陷部分具有减小的轮廓,以便进一步减小横截面,比如,减小至2mm 或更少以便容纳用于植入引线的5Fr护套。在一些实施例中,锚定件包括可以 彼此附接且彼此相邻地部署的多个锚定件区段。这种特征可以允许用户关于锚 定件的长度和尖齿方向而定制锚定部分,通过颠倒锚定件或将不同类型的锚定 件组合在锚定部分内。锚定件可以进一步包括一个或多个附加特征,包括以下 各项中的任何项:延伸螺旋主体的实长的不透射线元件以便促进使用可视化技 术来进行定位;适合于屏蔽由磁共振引起的发热的嵌入式屏蔽材料;以及可生 物降解尖齿或药物洗脱尖齿。
在某些实施例中,螺旋主体是连续螺旋阀瓣,并且所述多个尖齿包 括连续螺旋阀瓣的多个区段,所述多个区段由沿着连续螺旋阀瓣的长度的多个 切口限定,以便允许所述多个区段向内折叠而不会彼此重叠。
在其他实施例中,锚定件通过以下方式形成:对材料(例如,聚合 物或金属,比如,镍钛诺)的管状部分进行激光切割,以及在锚定件处于展开 构型中时通过热定形或回流来定形材料。在仍其他实施例中,锚定件可以通过 将在多件式模具组件中对聚合物材料进行注塑成型来形成,这允许在锚定结构 中的进一步可变性,比如,锚定件的不同部分的变化厚度。
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根据本发明的各方面示意性地展示了神经刺激***,所述神经 刺激***包括用于对试验神经刺激***和永久性植入式神经刺激***两者进 行定位和/或程控的临床医生程控器和患者遥控器。
图2A至图2C示出了沿着脊柱、下背部和骶骨区域的可以根据本 发明的各方面进行刺激的神经结构的图示。
图3A根据本发明的各方面示出了完全植入式神经刺激***的示 例。
图3B根据本发明的各方面示出了神经刺激***的示例,所述神经 刺激***具有用于试验刺激的部分植入式刺激引线以及粘附至患者皮肤的外 部脉冲发生器。
图4根据本发明的各方面示出了神经刺激***的示例,所述神经刺 激***具有可植入刺激引线、可植入脉冲发生器、和外部充电设备。
图5A至图5C根据本发明的各方面示出了用于神经刺激***的可 植入脉冲发生器和相关联部件的详细视图。
图6A至图6C根据本发明的各方面示出了用于与神经刺激引线和 可植入脉冲发生器一起使用的应变消除结构。
图7根据本发明的各方面展示了其上具有锚定件结构的神经刺激 引线。
图8根据本发明的各方面展示了示例锚定件结构。
图9A和图9B根据本发明的各方面展示了在展开之前和之后的其 上具有锚定件结构的神经刺激引线。
图10A和图10B根据本发明的各方面展示了示例锚定件结构。
图11A和图11B根据本发明的各方面展示了示例锚定件结构。
图12A和图12B根据本发明的各方面展示了示例锚定件结构。
图13A和图13B根据本发明的各方面展示了示例锚定件结构。
图14A和图14B根据本发明的各方面展示了示例锚定件结构。
根据本发明的各方面,图15A至图15C展示了在展开之前和之后 的示例锚定件结构,并且图15C展示了展开锚定件结构的端视图。
图16A和图16B根据本发明的各方面展示了通过激光切割来形成 的示例锚定件结构(在展开之前和之后示出的结构)。
图17A和图17B根据本发明的各方面展示了通过注塑成型过程来 形成的替代性示例锚定件结构。
图18至图20根据本发明的各方面展示了形成锚定件的方法以及锚 定神经刺激引线的方法。
具体实施方式
本发明涉及神经刺激治疗***和相关联设备;以及这种治疗***的 治疗、植入/放置和配置方法。在特定实施例中,本发明涉及被配置成用于治疗 膀胱功能障碍(包括膀胱过度活动症(“Overactive Bladder,OAB”))以及 大便功能障碍并缓解与其相关联的症状的骶神经刺激治疗***。然而,将理解 的是,如本领域的技术人员将理解的,本发明还可以用于治疗疼痛或其他适应 症,比如,运动障碍或情感障碍。
I.神经刺激适应症
神经刺激治疗***(比如,本文中所描述的神经刺激治疗***中的 任何神经刺激治疗***)可用于治疗各种各样的疾病和相关联的症状(比如, 急性疼痛障碍、运动障碍、情感障碍、以及与膀胱相关的功能障碍和肠功能障 碍和大便功能障碍)。可通过神经刺激来治疗的疼痛障碍的示例包括腰椎手术 失败综合征、反射***感神经营养不良或复杂性区域疼痛综合征、灼痛、蛛网 膜炎、和周围神经病变。运动顺序包括肌肉麻痹、震颤、肌张力障碍、和帕金 森病。情感障碍包括抑郁、强迫症、丛集性头痛、图雷特综合症、以及某些类型的慢性疼痛。膀胱相关功能障碍包括但不限于OAB、急迫性尿失禁、尿急- 尿频、和尿潴留。OAB可以单独地或组合地包括急迫性尿失禁和尿急-尿频。 急迫性尿失禁是与突然强烈的排放欲望相关联的无意识流失或尿液(尿急)。 尿急-尿频是通常导致非常小量的***(尿频)的频繁、通常不可控的排尿欲 望(尿急)。尿潴留是无法排空膀胱。神经刺激治疗可以被配置成用于通过对 目标神经组织实施与关联于特定病情或相关联症状的感觉和/或运动控制相关 的神经刺激来处理该病情。
在一方面,本文中所描述的方法和***特别适合于治疗泌尿和大便 功能障碍。医学界在历史上还未意识到这些病情,并且对这些病情显著地缺医 少药。OAB是最常见的泌尿功能障碍之一。它是由麻烦的泌尿症状(包括尿 急、尿频、夜尿症、和急迫性尿失禁)的存在表征的复杂病情。据估计,约4 千万美国人患有OAB。成年人口中,所有男性和女性中大约16%患有OAB症 状。
OAB症状可能对患者的社会心理功能和生活质量具有显著的负面 影响。患有OAB的人员通常限制活动和/或开发应对策略。此外,OAB给个人、 他们的家庭和医疗机构施加了显著的财政负担。患有OAB的患者的合并症病 情患病率比普通人群中的患病率显著更高。合并症可以包括跌倒骨折、尿路感 染、皮肤感染、外阴***炎、心血管疾病、和中枢神经***病理。在患有OAB 的患者更频繁地发生慢性便秘、大便失禁、和重叠的慢性便秘。
OAB的常规治疗通常包括作为第一行动步骤的生活方式改变。生 活方式改变包括将膀胱刺激物(比如,咖啡因)从食物中消除、管理液体摄取、 降低体重、停止吸烟、以及管理肠规律性。行为改变包括改变***习惯(比如, 膀胱训练和延迟的***)、训练盆底肌以便改善尿道***的力量和控制、生 物反馈、和用于欲望抑制的技术。药物被认为是对OAB的二线治疗。这些药 物包括抗胆碱药物(口服、皮肤药贴、和凝胶)和口服β3肾上腺素能激动剂。 然而,抗胆碱药物经常与麻烦的***性副作用(比如,口干、便秘、尿潴留、 视力模糊、嗜睡、和困惑)相关联。研究发现,超过50%的患者在90天内由 于缺少效果、不良事件或费用原因而停止使用抗胆碱药物。
当这些方式成功时,美国泌尿协会建议的三线治疗选择包括肉毒杆 菌毒素(BTX)的逼尿肌内(膀胱平滑肌)注射、经皮胫神经刺激(PTNS)、 和骶神经刺激(SNM)。BTX在膀胱镜检查指导下经由逼尿肌内注射来提供, 但是通常需要每隔4到12个月进行重复的BTX注射以便维持效果,并且BTX 可能不期望地导致尿潴留。许多随机对照研究显示了BTX注射对OAB患者的 一些效果,但是BTX对OAB的长期安全性和有效性在很大程度上是未知的。
PTNS治疗由每周30分钟疗程(在12周的时间内)组成,每一个 疗程使用经由胫神经来从手持式刺激器递送至骶丛的电刺激。对于反应良好且 继续治疗的患者,需要持续疗程(通常每隔3到4周)来维持症状减轻。如果 患者未能坚持治疗时间表,那么效果有可能降低。在很少随机对照研究中展示 了PTNS的效果,然而,关于超过3年的PTNS有效性的数据有限,并且对于 寻求治愈急迫性尿失禁(UUI)(例如,100%减少失禁事件)(EAU指南) 的患者,不推荐PTNS。
II.骶神经调节
SNM是已确定的治疗,其针对急迫性尿失禁、尿急-尿频和非阻塞 性尿潴留提供安全、有效、可逆和持久的治疗选择。SNM治疗涉及使用温和 型电脉冲来刺激位于下背部中的骶神经。通过将电极引线***骶骨的相应孔中 来将电极放置在骶神经(通常在S3级)旁边。电极被***在皮下并且随后被 附接至可植入脉冲发生器(IPG)。SNM对OAB治疗的安全性和有效性(包 括五年内对急迫性尿失禁和尿急-尿频患者的耐久性)由多项研究支持并被良好记录。SNM还被批准用于治疗已经失败或者并非更保守治疗的人选的患者 的慢性大便失禁。
A.对骶神经调节***的植入
当前,SNM资质处于试验阶段,并且如果成功,则随后进行永久 性植入。试验阶段是测试刺激期,在所述测试刺激期内,允许患者评估治疗是 否有效。通常,存在用于执行测试刺激的两种技术。第一种技术是被称为经皮 神经评估(PNE)的基于诊室的过程,并且另一种技术是阶段性试验。
在PNE中,通常首先使用孔针来标识最优刺激位置(通常在S3 级)以及来评估骶神经的完整性。如在下表1中所描述的,运动反应和感觉反 应用于验证正确的针放置。然后,将临时性刺激引线(单极电极)放置在局部 麻醉的骶神经附近。可以在不需要荧光镜检查的情况下在诊室设置中进行此过 程。然后,将临时性引线连接至在试验阶段用胶带连接到患者皮肤上的外部脉 冲发生器(EPG)。可以调节刺激水平,以便向特定患者提供最优舒适水平。 患者将监测他或她的***3到7天,以便查看是否存在任何症状改善。PNE的 优点是:它是可以在内科医生诊室中使用局部麻醉来执行的无切口过程。缺点 是:临时性引线未被牢固地锚定在位并且具有通过物理活动来迁移离开神经的 倾向并且由此导致治疗失败。如果患者在此试验测试中失败,则内科医生仍可 以推荐如以下所描述的阶段性试验。如果PNE试验为阳性,则移除临时性试 验引线并且在全身麻醉下连同IPG植入永久性四极尖齿形引线。
阶段性试验涉及从一开始将永久性四极尖齿形刺激引线植入到患 者体内。其还需要使用孔针来标识神经和最优刺激位置。引线被植入在S3骶 神经附近并且经由引线延伸段被连接至EPG。在手术室中、在荧光镜检查指导 以及在局部和全身麻醉下执行此过程。调节EPG以便向患者提供最优舒适水 平,并且患者监测他的或她的***高达两周。如果患者获得有意义的症状改善, 则他或她被考虑为在全身麻醉下进行IPG的永久性植入(通常在如图1和图 3A中所示出的上臀部区域中)的适当人选。
表1:SNM在不同骶神经根处的运动反应和感觉反应
*夹紧:******的收缩;以及在男性中,***根部缩回。将臀部移到 旁边并寻找***结构的前/后缩短。
**管:骨盆底的提升和下降。寻找臀沟的加深和压扁。
关于测量对***功能障碍的SNM治疗的疗效,通过唯一的主要排 泄日记变量来评估***功能障碍适应症(例如,急迫性尿失禁、尿急-尿频、 和非阻塞性尿潴留)。使用这些相同变量来测量治疗疗效。如果相比于基线, 在主要***日记变量中的任何主要***日记变量中发生最少50%的改善,则认 为SNM治疗成功。对于急迫性尿失禁患者,这些***日记变量可以包括:每 天泄露事件的数量、每天严重泄露事件的数量、和每天使用的护垫的数量。对 于患有尿急-尿频的患者,主要***日记变量可以包括:每天***次数、每次 ***排出的量以及在每次***之前经历的急迫性程度。对于患有潴留的患者, 主要***日记变量可以包括:每次导尿的导尿量和每天导尿次数。对于大便失 禁患者,***日记所捕获的疗效测量包括:每周泄露事件的数量、每周泄露天 数、和每次泄露之前经历的急迫性程度。
SNM的运动机制是多因素的并且以若干不同的水平影响神经轴。 对于患有OAB的患者,据信,***传入神经可以激活抑制反射,所述抑制反 射通过抑制异常***反射的传入肢来促进膀胱存储。这阻塞了到脑桥排尿中枢 的输入,由此在不妨碍正常***模式的情况下限制了无意识的逼尿肌收缩。对 于患有尿潴留的患者,SNM被认为激活了源自盆腔器官到脊髓中的***传入 神经。在脊髓级,***传入神经可以通过抑制过度保护反射来启动***反射, 由此减轻患有尿潴留的患者的症状,从而可以促进正常***。对于患有大便失禁的患者,假设的是,SNM刺激了抑制结肠推进活动的***传入体纤维并激 活了***内***,这进而改善了大便失禁患者的症状。
本发明涉及被适配成用于采用导致对目标神经纤维的部分或完全 激活、引起对与膀胱和肠功能相关联的器官和结构进行控制的神经(有可能与 刺激目标相同或不同)中的神经活动的增强或抑制的方式来向目标神经组织递 送神经刺激的***。
B.EMG辅助的神经刺激引线放置和程控
虽然常规的骶神经刺激方式在对与膀胱和肠相关的功能障碍的治 疗方面已经展现出了效果,但是需要改进对神经刺激引线的定位以及引线的试 验植入位置与永久性植入位置之间的一致性,并且需要改进程控方法。神经刺 激依赖于经由一个或多个神经刺激电极来将治疗刺激从脉冲发生器一致地递 送至特定神经或目标区域。在可植入引线的可以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。可植入神经刺激***向患者提供很大的自由和 移动性,但是在通过手术来植入这种***的神经刺激电极之前,可能更容易对 其进行调节。令人期望的是,在植入IPG之前,内科医生确认患者具有所期望的运动反应和/或感觉反应。对于至少一些治疗(包括对至少一些形式的泌尿功 能障碍和/或大便功能障碍的治疗),展示适当的运动反应对准确且客观的引线 放置而言可能非常有益,而可能不需要或不可获得感觉反应(例如,患者处于 全身麻醉)。
将神经刺激电极和可植入引线放置和校准为足够靠近特定神经对 治疗的效果而言可能是有益的。相应地,本公开的方面和实施例涉及帮助和改 善神经刺激电极放置的准确度和精度。进一步地,本公开的方面和实施例针对 帮助和改善用于对通过植入式神经刺激电极来实施的刺激程序设置治疗处理 信号参数的方案。
在植入永久性设备之前,患者可能经受初始测试阶段,以便估计对 治疗的潜在反应。如以上所描述的,PNE可以在局部麻醉下完成,根据患者的 主观感觉反应、使用测试针来标识(多个)适当的骶神经。其他测试过程可以 涉及二阶段手术过程,在所述二阶段手术过程中,针对测试阶段(第一阶段) 而植入四极尖齿形引线,以便判定患者是否显示出充分的症状减轻频率,并且 在适当情况下,继续对神经调节设备的永久性手术植入。对于测试阶段和永久 性植入,确定引线放置的位置可能取决于患者或内科医生中的任一者或两者的 主观定性分析。
在示例性实施例中,判定可植入引线和神经刺激电极是否位于所期 望的或正确的位置中可以通过使用肌电图(“EMG”)(也被称为表面肌电图) 来完成。EMG是使用EMG***或模块来评估和记录肌肉所产生的电活动的技 术,产生被称为肌电图的记录。当肌肉细胞被电激活或神经激活时,EMG检 测那些细胞生成的电位。可以对信号进行分析,以便检测激活水平或募集相。 可以通过患者的皮肤表面、肌内地、或通过布置在患者体内靠近目标肌肉的电 极、或使用外部或内部结构的组合来执行EMG。当肌肉或神经由电极刺激时, EMG可以用于响应于刺激而判定相关肌肉是否被激活(即,肌肉是否完全收 缩、部分收缩、或不收缩)。相应地,肌肉的激活程度可以指示可植入引线或 神经刺激电极是否位于患者身体上的期望或正确位置中。进一步地,肌肉的激 活程度可以指示神经刺激电极是否正提供足够强度、振幅、频率或持续时间的 刺激来在患者身体上实施治疗方案。由此,对EMG的使用提供了客观且定量 的方式,通过所述方式来标准化对可植入引线和神经刺激电极的放置,减少了 对患者感觉反应的主观评价。
在一些方式中,位置滴定过程可以可选地部分基于来自患者的感觉 异常或基于疼痛的主观反应。相比而言,EMG触发了可测量且离散的肌肉反 应。由于治疗效果通常依赖于神经刺激电极在目标组织位置处的精确放置以及 对神经刺激治疗的恒定重复递送,所以使用客观EMG测量可以大大提高SNM 治疗的效用性和成功性。根据对目标肌肉的刺激,可测量的肌肉反应可以是部 分或完全肌肉收缩,包括如在表1中所示出的低于对可观察的运动反应的触发 的反应。此外,通过利用允许神经刺激引线保持植入以供用于永久性植入式系 统的试验***,永久性植入式***的效果和疗效与试验期的结果更一致,这进 而导致改善的患者疗效。
C.示例***实施例
图1根据本发明的各方面示意性地展示了示例神经刺激***设置, 所述示例神经刺激***设置包括用于试验神经刺激***200的设置以及用于永 久性植入式神经刺激***100的设置。EPG 80和IPG 50中的每一者都与临床 医生程控器(CP)60和患者遥控器70兼容和无线地通信,所述临床医生程控 器和所述患者遥控器用于对试验神经刺激***200和/或(在成功试验之后)永 久性植入式***100进行定位和/或程控。如以上所讨论的,***在试验***设 置100中利用成套电缆和EMG传感器贴片来促进引线放置和神经刺激程控。CP可以包括用于辅助引线放置、程控、重新程控、刺激控制和/或参数设置的 专用软件、专用硬件和/或两者。此外,IPG和EPG中的每一者都允许患者对 刺激具有至少一些控制(例如,启动预设程序、增大或减小刺激)和/或使用患 者遥控器来监测电池状态。这种方式还允许试验***与永久性***之间的几乎 无缝转换。
在一方面,在引线被植入在患者体内时,CP 60由内科医生用于调 节EPG和/或IPG的设置。CP可以是临床医生用于对IPG进行程控或在试验 期内控制EPG的平板计算机。CP还可以包括对刺激诱发肌电图进行记录以便 促进引线放置和程控的能力。患者遥控器70可以允许患者接通或断开刺激, 或者改变在被植入时来自IPG的或者在试验阶段来自EPG的刺激。
在另一方面,CP 60具有控制单元,所述控制单元可以包括微处理 器和专用计算机代码指令,所述专用计算机代码指令用于实施临床内科医生用 于部署治疗***和设置治疗参数的方法和***。CP通常包括图形用户界面、 EMG模块、可以耦合至EMG输出刺激电缆的EMG输入端、EMG刺激信号 发生器、和刺激电源。刺激电缆可以被进一步配置成耦合至进入设备(例如, 孔针)、***的治疗引线等中的任何一项或所有项。EMG输入端可以被配置成与用于附接至患者的与肌肉(例如,由目标神经衰弱的肌肉)相邻的皮肤的 一个或多个感觉贴片电极耦合。CP的其他连接器可以被配置成与电接地或接 地贴片、电脉冲发生器(例如,EPG或IPG)等耦合。如以上所指出的,CP 可以包括具有用于执行EMG分析的硬件或计算机代码的模块,其中,所述模 块可以是控制单元微处理器的部件、耦合至刺激和/或感觉电缆或者与其连接的 预处理单元等。
在其他方面,每当引线连接至EPG、IPG或CP时,CP 60允许临 床医生读取每一个电极触点的阻抗,以便确保做出可靠连接并且引线完好。这 可以用作对引线进行定位和对引线进行程控两者的初始步骤,以便确保电极适 当运行。CP 60还能够保存和显示患者用于帮助促进冲程控的先前(例如,高 达最后四个)程序。在一些实施例中,CP 60进一步包括用于将报告保存到USB 驱动器的USB端口和充电端口。CP被配置成用于在将引线放置在患者身体内 时结合EPG以及在程控期间结合IPG进行操作。在测试模拟期间可以通过专 用成套电缆或通过无线通信来将CP电子地耦合至EPG,从而允许CP对连接 至EPG的引线上的电极进行配置、修改或以其他方式程控。CP还可以包括用 于接通和断开CP和/或用于接通和断开刺激的物理开/关按钮。
EPG和IPG生成的电脉冲经由一个或多个电极中的每一个电极的 远端处或附近的一个或多个神经刺激电极被递送至一个或多个目标神经。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、形状和材料可以被定制成用于特定治疗应用。虽然在此实施 例中,引线具有适合于从IPG延伸并穿过骶骨的孔之一到达目标骶神经的大小 和长度,但是在各种其他应用中,引线可以例如被植入在患者身体的***部分 中(比如,在手臂或腿中),并且可以被配置成用于向***神经递送如可以用 于减轻慢性疼痛的电脉冲。应当理解的是,引线和/或刺激程序可能根据所定向 的神经而变化。
图2A至图2C根据本发明的各方面示出了患者的可以用于神经刺 激治疗的各种神经结构的图示。图2A示出了脊髓的不同区段以及每一个区段 内的相应神经。脊髓是从脑干沿着颈髓延伸、穿过胸髓并到达腰髓中的第一与 第二腰椎之间的空间的神经和支持细胞的细长束。离开脊髓后,神经纤维*** 成多个分支,所述分支对在脑与器官和肌肉之间传输感觉和控制脉冲的各种肌 肉和器官进行支配。因为某些神经可以包括支配如膀胱等某些器官的分支以及 支配腿和脚的某些肌肉的分支,所以对脊髓附近的神经根处或附近的神经的刺 激可以刺激支配目标器官的神经分支,这也可能导致与对另一个神经分支的刺激相关联的肌肉反应。由此,通过在视觉上、通过使用如本文中所描述的EMG 或两者来监测某些肌肉反应(比如,表1中的反应),内科医生可以判定目标 神经是否被刺激。虽然某个水平的刺激可能引起肉眼可见的稳健肌肉反应,但 是更低水平(例如,子阈值)的刺激仍可以在不引起任何相应肌肉反应或仅使 用EMG可见的反应的同时提供对与目标器官相关联的器官的激活。在一些实 施例中,这种低水平刺激也可以不引起任何感觉异常。因为其允许通过神经刺 激来治疗病情而不会以其他方式引起患者不适、疼痛或不期望的肌肉反应,所以这是有利的。
图2B示出了与下腰髓区域中的下背部区段相关联的神经,在所述 下腰髓区域中,神经束离开脊髓并行进穿过骶骨的骶孔。在一些实施例中,使 神经刺激引线前进穿过孔,直到神经刺激电极被定位在前骶神经根部为止,而 刺激电极近端的引线的锚定部分通常被布置在引线所穿过的骶孔的背侧,以便 将引线锚定在位。图2C示出了腰骶干和骶丛的神经(具体地,下骶骨的S1 至S5神经)的详细视图。对于膀胱相关功能障碍(并且特别是OAB)的治疗 而言,S3骶神经是特别感兴趣的。
图3A示意性地展示了被适配成用于骶神经刺激的完全植入式神经 刺激***100的示例。神经刺激***100包括IPG,所述IPG被植入在下背部 区域中并且被连接至延伸穿过S3孔以便刺激S3骶神经的神经刺激引线。引线 由尖齿形锚定部分30锚定(所述尖齿形锚定部分将一组神经刺激电极40的位 置维持为沿着目标神经,在此示例中,所述目标神经是支配膀胱的前骶神经根 S3),以便向各种膀胱相关功能障碍提供治疗。虽然此实施例被适配成用于骶 神经刺激,但是应当理解的是,类似***可以用于治疗患有例如源自周围神经或的慢性、严重、难治的神经病理性疼痛或各种泌尿功能障碍或仍进一步其他 适应症的患者。可植入神经刺激***可以用于刺激目标周围神经或脊柱的后硬 膜外空间。
电脉冲的特性可以经由植入的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、振幅、模式、持续时间 或其他方面。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3A中所描绘的实 施例中,可植入神经刺激***100包括IPG中具有可以按以上所讨论的方式来 重新程控或创建的一个或多个脉冲程序、计划或模式的控制器。在一些实施例 中,可以在植入所述永久性神经刺激***100之前使用的部分植入式试验*** 的EPG中使用与IPG相关联的这些相同的特性。
图3B示出了利用粘附至患者皮肤(具体地,附接至患者的腹部) 的EPG贴片81的试验神经刺激***200的示意图,EPG 80被包裹在贴片内。 在一方面,引线被硬接线至EPG,而在另一方面,引线通过柔性贴片81的顶 表面中的端口或孔口被可移动地耦合至EPG。多余引线可以通过附加的粘附贴 片来固定。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***中使用所述引线。可替 代地,整个***是可布置的并且可以使用永久性引线和IPG来对其进行替换。 如之前所讨论的,当植入了实验***的引线时,使用一个或多个传感器贴片、 经由CP来获得的EMG可以用于确保引线被放置在接近目标神经或肌肉的位 置处。
在一些实施例中,试验神经刺激***利用粘附至患者皮肤并且通过 引线延伸段22耦合至植入式神经刺激引线20的EPG贴片81内的EPG 80,所 述引线延伸段通过连接器21与引线20耦合。此延伸段和连接器结构允许对引 线进行延伸,从而使得EPG贴片可以放置在腹部上,并且如果试验证明成功, 则允许使用具有适合于永久性植入的长度的引线。此方式可以利用两个经皮切 口,在第一切口中提供连接器并且引线延伸段延伸穿过第二经皮切口,在其之 间存在短的穿隧距离(例如,约10cm)。这种技术还可以在将实验***转换为永久性植入式***期间使所植入的引线的移动最小化。
在一方面,通过患者遥控器和/或CP、采用与永久性植入式***的 IPG相似或完全相同的方式来无线地控制EPG单元。内科医生或患者可以通过 使用这种便携式遥控器或程控器来改变EPG所提供的治疗,并且所递送的治 疗被记录在程控器的存储器上,以供用于确定适合于在永久性植入式***中使 用的治疗。在试验神经刺激***和永久性神经刺激***中的每一者中,CP可 以用于引线放置、程控和/或刺激控制。此外,每一个神经刺激***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***与永久 性***之间的几乎无缝转换,所以其是有利的。从患者的角度来看,***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***,从而使得患者使用 试验***的主观体验与将在使用永久性植入式***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***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接纳实验***或永久系 统。
如在图3B的详细视图中所示出的,EPG 80被包裹在柔性分层贴片 81内,所述柔性分层贴片包括EPG 80通过其来连接至引线延伸段22的孔口 或端口。所述贴片可以进一步包括具有模塑的触觉细部的用于允许患者通过粘 附贴片81的外表面来接通和/或断开EPG的“开/关”按钮83。贴片81的下侧 覆盖有与皮肤相容的粘附剂82,以供连续附接至患者试验期的持续时间。例如, 具有与皮肤相容的粘附剂82的透气性条带将允许EPG 80在试验期间保持连续 附接至患者,所述试验可能持续超过一周(通常两周到四周)或甚至更长的时间。
虽然以上所描述的***在定位引线的最优位置和微调引线放置方 面提供了相当大的改进并且确定了最优神经刺激程序,但是当务之急是,在成 功放置引线之后,确保在整个治疗过程内维持引线位置。如果神经刺激引线迁 移,甚至很小的轴向距离,则电极可能从目标神经处移动,从而使得在不对引 线进行重编程或重定位的情况下,神经刺激治疗可能不递送一致的结果或者不 再提供治疗效果。
在可完全植入***中,脉冲发生器被植入在患者体内大小足够于舒 适地包含脉冲发生器的区域中,通常在下背部区域或下腹部区域中。因为电极 可能需要被定位成离可植入脉冲发生器相当远的距离,但是根据所递送的治疗 或疗法,神经刺激引线用于将电脉冲从植入脉冲发生器递送到电极。虽然许多 这种***已经证明有效,但是研究表明神经刺激引线可能随着时间移动,特别 是当引线延伸穿过经受移动的区域时。这种移动可能使电极与目标位置错开, 从而使得神经刺激治疗变得无效,需要对引线进行调整或替换。因此,期望的 是,在这种***中的刺激引线上提供锚定设备以便抑制引线的移动和电极的错位。虽然常规神经刺激已经发展了各种锚定机制,但是这种机制通常使植入程 序复杂化、不期望地增大引线的递送轮廓、难以替换或移除、或者证明无效。
图4展示了完全可植入的且被适配成用于骶神经刺激治疗的示例 神经刺激***100。可植入***100包括IPG 90,所述IPG耦合至神经刺激引 线20,所述神经刺激引线包括处于引线远端的一组神经刺激电极40。引线包 括具有一系列尖齿的引线锚定部分30,所述尖齿放射状地向外延伸,以便在植 入之后锚定引线并维持神经刺激引线20的位置。引线20可以进一步包括用于 辅助使用如荧光镜检查等可视化技术来安置和定位引线的一个或多个不透射 线标记(例如,硅标记)25。在一些实施例中,IPG提供通过一个或多个神经 刺激电极来向目标神经递送的单极或双极电脉冲。在骶神经刺激时,通常通过 如在本文中所描述的S3孔来植入引线。
如在图4中可以看到的,神经刺激引线20包括引线的远端处的多 个神经刺激电极30,并且锚定件10被布置在电极30的近端。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。因 为这种配置允许在植入期间、在展开锚定件之前(如以下所描述的)对神经刺 激电极进行测试(这允许在引线被锚定在位之前确定神经刺激电极的最优位 置),所以所述配置也是有利的。如所示出的,锚定件10包括绕引线主体螺 旋状扫过的锚定件主体12以及从螺旋主体12处横向地向外延伸的多个尖齿 14。因为这种构型提供了在从共同锚定件主体处延伸的同时围绕引线既圆周地 也轴向地分布的多个尖齿(由此简化了对锚定尖齿的附接和替换),所以所述 构型是有利的。此外,因为锚定件主体在引线主体周围螺旋状地延伸,所以这 允许在尖齿形区域中保留引线主体的柔韧性。在一方面,锚定件由与形成引线 主体的且柔性到足以在不损伤组织的情况下提供相对组织的锚定力的材料生 物相容和相容的适当材料构造。
在一方面,可以利用充电设备50(CD)、通过电导耦合来对IPG 进行无线再充电,所述充电设备是由可再充电电池供电的便携式设备,以便在 充电的同时允许患者移动性。CD用于通过RF感应来对IPG进行经皮充电。 可以使用粘附剂来将CD贴在患者皮肤上或者可以使用如图1的示意图中所示 出的带53或粘附剂贴片52来将其固定在位。可以通过将CD直接***到插座 中或通过将CD放置在连接至AC壁式插座或其他电源的充电座或充电站51 中从而对CD进行充电
图5A至图5C示出了IPG及其内部部件的详细视图。在一些实施 例中,脉冲发生器可以生成向神经递送的以便控制疼痛或引起一些其他期望的 效果(例如,以便抑制、阻止或中断神经活动)的一个或多个非消融性电脉冲, 从而治疗OAB或膀胱相关功能异常。在一些应用中,可以使用脉冲振幅范围 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***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 或等的可商购获得的微处理器等微处理器。IPG可以包括 如一个或多个电容器或电池、一个或多个电池等能量存储特征,并且通常包括 无线充电单元。
电脉冲的一个或多个特性可以经由IPG或EPG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、振幅、模式、持 续时间或其他定时和幅度方面。这些特性可以进一步包括例如电压、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。 在一方面,IPG 90包括具有可以创建和/或重新程控的一个或多个脉冲程序、 计划或模式的控制器。在一些实施例中,IPG可以被程控成用于改变刺激参数 (包括在从0mA到10mA范围内的脉冲幅度、在从50μs到500μs范围内的 脉冲宽度、在从5Hz到250Hz范围内的脉冲频率、刺激模式(例如,连续的 或循环的)、以及电极配置(例如,阳极、阴极或关闭)),以便实现特定于 患者的最优治疗疗效。具体地,这允许对每一位患者而确定最优设置(即使每 一个参数可能因人而异)。
如在图5A和图5B中所示出的,IPG可以包括处于一端的头部部 分11以及处于相对端的陶瓷部分14。头部部分11容纳馈通组件12和连接器 栈13,而陶瓷壳部分14容纳用于促进与临床医生程序、患者遥控器和/或用于 促进使用CD来进行的无线充电的充电线圈的无线通信的天线组件16。IPG的 剩余部分被钛壳部分17覆盖,所述钛壳部分包裹促进以上所描述的电脉冲程 序的印刷电路板、存储器和控制器部件。在图5C中所示出的示例中,IPG的头部部分包括与连接器栈13耦合的四引脚馈通组件12,在所述连接器栈中, 耦合了引线的近端。四个引脚与神经刺激引线的四个电极相对应。在一些实施 例中,巴尔密连接块被电连接至四个铂/铱合金馈通引脚,所述引脚连同钛 合金凸缘被钎焊至氧化铝陶瓷绝缘体板。此馈通组件被激光缝焊接至钛-陶瓷 钎焊的壳以便形成用于电子器件的完整的气密外壳。
在图5A中所示出的IPG中,在IPG的一端上利用陶瓷和钛钎焊的 壳,铁氧体线圈和PCB天线组件被定位在所述一端处。经由陶瓷到金属 (Ceramic-to-Metal)钎焊技术来提供可靠的气密密封。氧化锆陶瓷可以包括 3Y-TZP(3mol%氧化钇稳定的四方氧化锆多晶体)陶瓷,其具有高弯曲强度和 抗冲击性并且已经在许多可植入医疗技术中对其进行商业使用。然而,将理解 的是,其他陶瓷或其他适当的材料可以用于构造IPG。
由于通信天线被容纳在气密陶瓷壳之内,所以对陶瓷材料的利用提 供了用于与外部患者遥控器和临床医生的程控器进行无线通信的有效的射频 透明窗。在维护用于IPG与外部控制器(比如,患者遥控器和CP)之间的长 期且可靠的无线通信的有效的射频透明窗的同时,此陶瓷窗已经进一步促进了 对植入物的微型化。不像现有技术产品(在现有技术产品中,通信天线被放置 在气密壳之外的头部中),IPG的无线通信在设备的使用期内通常是稳定的。 这种现有技术设备的通信可靠性由于人体中的头部材料的介电常数随着时间 的变化而趋于降级。铁氧体磁心是图5B中所示出的被定位在陶瓷壳94之内的 充电线圈组件95的一部分。铁氧体磁心通过与金属壳部分97相反的陶瓷壳来 聚集磁场通量。这种配置将耦合效率最大化,这降低了所需要的磁场并进而降 低了充电期间的设备发热。具体地,因为磁场通量被取向为在垂直于最小金属 横截面区域的方向上,所以最小化了充电期间的发热。应当理解的是,仅出于 说明性目的而描述这些IPG结构和神经刺激引线,并且本文中所描述的锚定结 构可以与根据本发明的原理的各种其他神经刺激引线和IPG一起使用。
所述引线的近端包括多个导体,所述多个导体与在远端处与头部部 分91内的连接器栈93内的相应触点电耦合(由此将IPG触点与引线20的神 经刺激电极40连接,以便递送神经刺激治疗)的多个电极相对应。尽管限制 了在IPG所定位的后背部区域中的移动,但是引线仍然可能由于各种原因而经 受力量和轻微移动,例如,由于组织容量的改变、***所植入的组织区域的创 伤、或者常规肌肉运动。当这些力量和运动随着时间而重复时,引线近端部分 与IPG之间的连接可能由于柔性引线和IPG头部部分91的结点处存在的刚度失配的点处的重复应力和应变所引起的疲劳而变得受损。在一些实施例中,包 括了沿着引线离开头部部分91的引线近端部分延伸的应变消除元件,以便在 引线的近端部分与所述IPG的结点处提供应变消除,从而维持电连接的完整性 并延长引线的使用寿命。
在一些实施例中,***包括沿着相邻IPG的头部部分的引线近端 部分延伸的应变消除元件。应变消除元件可以布置在引线近端部分周围或者可 以整合到引线自身中。应力消除元件可以包括与IPG的头部部分附接或对接的 近端基部。在一些实施例中,应变消除元件是在引线的近端部分周围延伸的螺 旋元件。应变消除元件可由金属(例如,不锈钢)、聚合物或任何其他适当材 料形成。引线的近端部分可以包括应变消除元件所存在的凹陷部分,从而使得 应变消除元件的外表面与引线的外表面基本上齐平或大约齐平。可替代地,应 变消除元件可以根据需要而应用于沿着引线的任何位置的非凹陷部分或标准 尺寸部分。通常,应变消除元件长度在约1英寸到约6英寸的范围内,以便减 少IPG附近的引线近端部分的弯折或弯曲,这可能随着时间而损害电连接。在 一方面,应变消除元件被形成为以便沿着纵向轴线具有增大的刚度,从而抑制 引线的近端部分的横向弯曲。本文中关于螺旋锚定件主体的结构和设计而描述 的方面中的任何方面可适用于应变消除元件。
在一些实施例中,如在图6C中所示出的,应变消除元件27包括 螺旋结构,所述螺旋结构沿着引线20的与引线20被***到IPG 90的头部部 分91的位置相邻的近端部分延伸。应变消除元件27可以包括被配置成用于牢 固地附接至头部部分91的近端基部28和环绕引线的近端部分的螺旋部分29。 通常,螺旋部分29抑制如相比于引线的增大的刚度,从而使得螺旋部分29经 受在近端区域中施加到引线上的任何应力或力量。此外,螺旋结构限制了所述 区域中的最小弯曲半径,这阻止了可能损坏应变消除位置处的引线的突然弯曲。应变消除元件可由任何适当的生物相容材料(包括聚合物或各种金属(例 如,不锈钢、镍钛诺)形成。应变消除构件可以在制造时附接至引线,或者可 替代地,在植入或附接至IPG连接器的时间装载到引线上。
在一方面,应变消除元件足够薄,从而使得其低轮廓不会大幅度增 大穿过护套的引线的最大横截面轮廓或横断轮廓。在一些实施例中,引线的近 端部分可以具有减小的直径和尺寸,以便适配地接纳应变消除构件,从而使得 应变消除构件与应变消除构件远端的引线外表面基本上齐平。
图6A和图6B分别展示了示例应变消除构件27和27’的详细视图, 每一个示例应变消除构件包括用于固定至IPG头部部分的近端基部28以及用 于卷绕在引线20的近端部分上的螺旋应变消除部分29。可以根据特定IPG头 部部分来对近端基部部分28进行大小设定和尺寸设定。在一方面,螺旋部分 29可以被配置成用于沿着引线的近端部分的长度提供可变刚度。例如,沿着应 变消除的长度,螺旋部分29可以具有可变厚度,以便在所述区域中提供逐渐 刚度转变和/或沿着应变消除的长度,螺旋部分的节距和/或宽度可以发生变化,以便在所述区域中提供渐变刚度并限制弯曲半径。在另一方面,应变消除元件 27可以包括类似于本文中所描述的锚定件的一个或多个尖齿(未示出),以便 向应变消除部分提供组织固定并进一步抑制引线的近端部分的移动或迁移。
III.通过螺旋锚定件来进行引线附着
图7展示了神经刺激引线20的详细视图,所述神经刺激引线类似 于图4中的神经刺激引线,具有安装在引线的锚定部分22上被示出为处于展 开构型的锚定主体10。如可以看到的,螺旋主体12绕中央纵向轴线螺旋状地 扫过以便放置在引线主体上,并且所述多个尖齿14沿着螺旋主体12分布,从 中央轴处横向地向外延伸并在近端方向上成一定角度。如在图8对10的详细 视图中所示出的,锚定主体的所述多个尖齿14分布成以便以间隔范围(比如, 在10°与90°之间)内的规律间隔(例如,30°、45°、90°)放射状地彼此偏移, 从而使得多个尖齿围绕中央轴在不同方向上圆周地向外延伸。这围绕引线主体 分布了任何锚定力,以便改善对引线的锚定。
在一方面,锚定体10包括嵌入在螺旋主体12内的不透射线条带16,以便允许通过可视化技术来进行对锚定件10的定位。不透射线条带可由 如铂合金(例如,Pt/lr)等任何不透射线材料制作,以便使用标准可视化技术 可见。因为这种条带促进将引线定位在目标位置处,所以它是有利的。在其他 实施例中,螺旋主体可由不透射线材料形成,例如,可以将不透射线材料混合 到形成锚定体的聚合物材料中。
图9A和图9B分别展示了具有递送构型和展开构型中的附接锚定 件的神经刺激引线。在图9A中,所述多个尖齿14折叠抵靠引线20体(而不 彼此重叠)或螺旋主体的相邻区段。通常,当引线前进穿过组织中的隧道到达 目标位置时,尖齿在递送构型中受外护套(未示出)约束。螺旋主体以一定的 节距掠过,以允许螺旋主体的相邻匝之间具有供标签向内折叠抵靠引线主体的 充分空间,这允许减小的递送轮廓。在一方面,锚定体的横截面小于2.0mm, 小到足以被递送穿过5Fr护套。在一方面,引线主体包括具有减小的外径的凹 陷部分22,螺旋主体12被附接在所述凹陷部分中。因为锚定体的近端和远端 紧靠凹陷部分的近端和远端并且允许引线的锚定体部分的减小的横截面轮廓 或横断轮廓,所以这种特征促进了锚定件10与引线主体20之间的耦合。一旦 确认了电极被递送至目标位置,就可以向近端抽回护套,由此允许所述多个尖 齿弹性地回到如图9B中所示出的展开构型(尖齿被偏置朝向展开构型)。
图10A和图10B展示了在图9B中被示出为在展开构型中的锚定体 10的详细视图。在此实施例中,尖齿14全部向近端倾斜。然而,应当理解的 是,在其他实施例中,锚定体10可以被配置成使得尖齿向远端或向近端成一 定角度、垂直于螺旋主体的纵向轴线延伸、或者在如期望用于特定应用的多个 不同方向上延伸。
在一方面,锚定体坚硬到足以施加充足的锚定力来将引线维持在位 且柔性到足以向内折叠抵靠引线且避免损伤组织(如果将引线从组织处移除) 的材料制作。在一些实施例中,锚定件由肖氏硬度在50A与80D之间(优选 地,约70D)的范围内的的模制聚氨酯制作。螺旋主体的宽度可以在1.0mm 与3.0mm之间(优选地,约2.0mm)并且总长度可以在10mm与30mm之 间(优选地,约20mm)。锚定件被配置成使得横断轮廓小于2.0mm(优选 地,1.7mm或更小),从而使得在其上附接有锚定件的引线可以通过标准护 套(比如,5Fr护套)来递送。在某些实施例中,尖齿的长度在1mm与3mm 之间(优选地,约1.8mm);宽度在0.5mm与2.0mm之间(优选地,约0.8 mm);厚度在约0.2mm与0.5mm之间(优选地,约0.3mm)。在某些实施 例中,锚定件包括10到20个尖齿(优选地,12到16个尖齿),所述尖齿沿 着螺旋主体的长度被间隔开,以便围绕引线在不同方向上圆周地延伸。在一些 实施例中,所有尖齿具有相同的长度并且在相同方向上成一定角度,而在其他 实施例中,尖齿可以具有变化的长度和宽度,并且可以在远端方向和近端方向 两者上成一定角度。虽然根据以上所描述的配置来将本文中所描述的锚定件中 的任何锚定件尺寸设计成用于促进通过5Fr护套来递送锚定件是有利地,但是 应当理解的是,可以根据如期望用于特定应用或神经刺激引线的各种其他尺寸 (长度、尖齿数量等)来配置锚定件。
图10A和图10B以及图11A和图11B展示了类似于图8中所示出 的锚定件的示例锚定件,除了尖齿14以不同形状形成以外。例如,在一方面, 如图8中所示出的,尖齿可以被形成为使得端面是有角度的或者尖的。在另一 方面,如在图10A和图10B中所示出的,尖齿可以被形成为基本上矩形的形 状。在另一方面,如在图11A和图11B中所示出的,尖齿可以被形成为使得 角和/或边缘是弯曲的、倒圆的或倒角的。在锚定引线期间当尖齿与组织接合时, 这种特征可以帮助减小尖齿的角或边缘对相邻组织造成的创伤的可能性。
图12A和图12B展示了类似于图8中的锚定件的示例锚定件,除 了所述多个尖齿在近端方向和远端方向上成一定角度以外。如可以看到的,最 近端尖齿在远端方向上成一定角度,而其余尖齿在近端方向上成一定角度。这 个方面可以用于在引线倾向于在近端方向和远端方向两者上经历力的应用中。 例如,虽然研究表明通过骶孔植入的神经刺激引线主要经历了在近端方向上引 导的力,但是如手臂或腿中的***植入的引线等各种其他应用可能在近端方向 和远端方向上经历显著的力。
图13A和图13B展示了包括多个锚定件区段10’的锚定件10。如 所示出的,锚定件由连接在一起的两个区段组成。锚定件区段10’可以是模块 化的,允许在引线上使用如特定引线或应用所需要的一个或多个锚定件区段。 锚定件区段可以包括用于将所述区段彼此附接或耦合的装置,或者可以通过本 领域的技术人员熟知的各种方法(比如,通过使用粘附剂、机械或化学耦合、 或氧化结合方法)来结合一起。这种特征可以允许用户根据期望、根据不同尖 齿的不同长度以及不同尺寸和/或方向来定制锚定部分。
图14A和图14B展示了具有螺旋拔塞器型形状的锚定件10。锚定 件包括连续螺旋阀瓣,所述连续螺旋阀瓣具有多个区段,所述多个区段通过将 螺旋阀瓣切割成可以朝着引线主体折叠而不彼此重叠的多个区段来限定。在一 方面,锚定件10由单个整体部件单片地形成。例如,锚定件10可由螺旋拔塞 器型结构形成,在所述螺旋拔塞器型结构中,螺旋阀瓣由在螺旋阀瓣中切割以 便对可以向下折叠抵靠引线(以便通过约束***护套来递送锚定件)的多个尖 齿14进行限定的楔形凹口15分成尖齿。
在另一方面,本文中所描述的锚定件中的任何锚定件可以包括一个 或多个各种其他特征,包括:可生物降解尖齿、药物洗脱尖齿、以及在达到某 个弯曲角度之后打开或折叠以便允许容易的***或缩回的柔性碟状尖齿。在另 一方面,锚定件可以包括屏蔽或中断由MRI引起的发热的条带或嵌入式材料。
在一方面,锚定件10包括在植入之后的某个时间段内释放一个或 多个治疗混合物的一个或多个药物洗脱部件。这种药物洗脱部件可以包括锚定 件的一部分、沿着锚定件的长度缠绕的条带、形成锚定件的材料、或者在锚定 件或其一部分上沉积的涂层。例如,可以将药物或治疗混合物喷洒在锚定件上, 锚定件可以浸泡在药物或混合物中,或者药物或混合物可以混合到形成锚定件 的聚合物中。在一些实施例中,锚定件可由生物可吸收或不可吸收聚合物材料 或涂覆有一层药物洗脱聚合物的不可吸收基部的组合来形成。在一方面,可以 应用药物或治疗混合物,以便促进在特定方向上释放药物,例如,可以应用药 物或混合物来促进沿着尖齿的轴线而各向同性地或各向异性地释放药物。可以 选择洗脱药物以便促进和缩短治愈时间从而使引线迁移的风险最小化。可替代 地或另外地,锚定件可以被配置成用于洗脱各种其他药物,从而提供各种其他 治疗效益。例如,锚定件10可以被形成为用于洗脱用于促进组织内的固定的 混合物,比如,用于在植入之后促进组织形成从而进一步使引线迁移的风险最 小化的生物粘附剂或混合物。
虽然在所示出的实施例中的许多实施例中,尖齿被配置成沿着平行 于纵向轴线(螺旋部分沿着所述纵向轴线延伸)的轴线突出和折叠,但是在一 些实施例中,锚定件可以被设计成使得尖齿沿着螺旋或倾斜轴线向内折叠。这 种构型可以允许通过在一个方向上扭转引线来缩回尖齿从而促进移除引线,和 /或允许通过在相对方向上扭转引线来进一步展开尖齿。在其他实施例(比如, 尖齿沿着平行于纵向轴线的轴线折叠的实施例)中,尖齿可能柔性和/或脆弱到 足以允许通过仅利用足够的力来缩回引线从而移除引线。
在一方面,可以通过在整块材料(例如,如镍钛诺等形状记忆金属) 中切割图案来形成锚定件。例如,可以通过在一根管子或一块圆柱形材料中激 光切割螺旋图案来形成锚定件,所述图案与如图15B的示例中所示出的处于约 束构型的锚定件相对应。然后,可以通过各种其他方式来在模具上支撑尖齿或 者将尖齿撑住,从而使得可以在锚定件处于如在图15A中所示出的展开构型中 时对材料进行热定形。通常,如在图15C中所示出的,将图案限定成使得尖齿 沿着螺旋主体的长度均匀分布,尖齿在多辐射方向上沿着螺旋的范围向外延 伸,以便在所有方向上提供均匀分布的组织固定。
在一方面,可以将螺旋基部热定形成具有比引线主体更小的内径, 以便提供过盈配合,之后可以扭转螺旋基部以便打开并且之后装载到引线主体 上。在释放之后,螺旋基部自动地缩紧在引线主体上,提供与引线的牢固附接。 螺旋设计被配置成使得当尖齿向下折叠时,尖齿不会彼此重叠或不会与锚定件 的螺旋主体重叠。
在另一方面,如在图15A中所示出的,锚定件设计可以分别包括 近端和远端处的一个或多个保持特征11、13,所述保持特征使得能够将锚定件 精确地锚定在设备上。在此实施例中,近端和远端保持特征11、13被设计成 紧靠引线的减小直径的锚定部分22的相应近端和远端,在所述减小直径的锚 定部分中接纳锚定件10以便将锚定件10附着到引线20体上并在递送引线和 展开锚定体10之前、期间和/或之后阻止锚定体10的轴向运动。在另一方面, 近端和远端保持特征11、13可以沿着近端和远端饰面边缘而被设计成各种形 状(例如,锯齿形的、弯曲的、有角的)以便与沿着引线在锚定部分22的近 端和远端处的相应形状互锁。这种配置可用于阻止锚定件10相对于引线主体 20的自由旋转移动或用于辅助在引线旋转之后将旋转移动平移至锚定件。
在一方面,锚定件10可由任何类型的可植入生物相容聚合物形成。 可以将如硫酸钡、铋和钨等不透射线填料添加到聚合物中,以便使尖齿在x射 线下是不透射线的。可替代地或另外地,可以将由如金或铂等不透射线金属制 成的带嵌入到螺旋主体中,以便将射线不透性添加到尖齿中。在另一种方法中, 锚定体可以包括一个或多个可以与可视化技术一起用于对锚定体进行定位或 者可以用于确定尖齿何时展开的一个或多个离散不透射线标记。例如,通过将 一对标记中的一个标记放置在尖齿端部并将另一个标记放置在螺旋主体上直 接与尖齿的端部相邻,当锚定件处于约束构型时,一对标记的分离可以指示尖 齿何时展开以及它们在组织内展开的程度。
图16A展示了另一种方法,可以通过所述方法来形成锚定体10。 如在图16A中所示出的,可以从一段挤压聚合物管上切除锚定体,例如,通过 激光切割。随后可以通过热定形或回流过程来将尖齿定形成具有向外突出的偏 置。例如,锚定体10可以安装在内部模具(未示出)上,所述内部模具在与 展开的锚定体配置相对应的向外突出的配置中支撑尖齿,并且对聚合物进行加 热或者允许对聚合物进行定形。在定形之后,锚定体10的尖齿14被偏置朝向 如图16B中所展示的展开构型。在一方面,这种加热和回流过程还可以用于并 入一个或多个不透射线标记,比如,以与螺旋相同的节距卷绕的Pt/Ir线或带。 在另一方面,聚合物管挤压可以并入带或线圈(例如,镍钛诺或金)带,以便 向锚定体尖齿提供自展开或自关闭形状记忆元件。激光切割可以被编程成用于 在嵌入式带线周围进行切割,以便将线包括在螺旋主体中。
图17A和图17B展示了又另一种方法,可以通过所述方法来 形成锚定体10。可以使用多件式模具设计、通过注塑成型来形成如本文中所描 述的螺旋锚定体中的任何螺旋锚定体等螺旋锚定体。例如,两片式模具设计、 三片式模具设计或四片式模具设计可以用于将锚定件模制成单个完整部件。在 一方面,模具可以被配置成以便以特定于锚定件的设计的角度释放锚定件。如 在图17A中所示出的,三片式模具17用于通过注塑成型过程来形成锚定件10。 核心销18连同模具一起用于形成锚定件的开放腔。图17B展示了也被配置成 与核心销18一起用于允许通过注塑成型过程来形成锚定件10的四件式模具设 计17’。使用注塑成型过程来形成锚定件的一个优点是模制的锚定件沿着部件 的长度可以具有变化的厚度。例如,这种锚定件可以被形成为使得基部更薄以 便提高横断轮廓,并且突出尖齿更厚以便在植入之后提供保持强度。在另一方 面,为了射线不透性,可以沿着整个长度在尖齿的位置处或在远端和近端并入 金属元件。
在图18和图19的示例中示出了根据本发明的以上所描述的 方面的形成锚定体的方法。图18的示例方法包括以下方法步骤:将螺旋图案 激光切割到材料的管状区段中,所述图案与具有处于约束构型的多个尖齿的神 经刺激引线锚定件相对应180;将所述管状区段的所述尖齿支撑在与所述锚定 件的展开构型相对应的向外突出位置中182;以及在所述尖齿被支撑的同时对 所述管状区段进行热定形,由此在所述锚定件处于所述展开构型时对所述材料 进行定形184。在一方面,材料是镍钛诺(优选地,在超弹性相中并且具有从 约15℃到约35℃的奥氏体结束温度),从而使得在身体内发热时,锚定体将 返回展开构型。在另一方面,材料可由聚合物材料形成,在展开构型中可以通 过加热和回流来对聚合物材料进行定形。可以向用户提供所述方法以便应用到 引线中,或者可以在向用户运输之前通过将锚定件卷绕在锚定部分上从而附着 至引线上186。图19的示例方法包括以下步骤:组装对螺旋锚定件的外表面进 行限定的多件式模具,所述螺旋锚定件具有多个向外延伸的尖齿,所述多件式 模具具有对锚定件的中央管腔进行限定的中央心销190;将可流动材料注入到 所述组装的模具中并且允许材料至少部分地定形194;以及移除模具以便释放 锚定件196。在一些实施例中,模具被配置成使得模具的外部片沿着尖齿延伸 的方向移除,这减小了移除期间施加到尖齿上的应力和力。在一些实施例中, 在组装期间将不透射线带添加到模具内和/或将不透射线材料添加到用于形成 锚定体的可流动材料中192。再次,可以向用户提供锚定体以便与引线组装, 或者可以将锚定体应用到引线上198以及可以向用户提供与引线组装的锚定 件。在另一方面,在准备好用于根据本文中所描述的植入方法来***到患者中 的约束护套内,锚定件可以提供有引线。
在图20的示例中示出了根据本发明的各方面的使用锚定体 来附着植入的神经刺激引线的方法。图20的示例方法包括以下步骤:提供神 经刺激引线,所述神经刺激引线具有一个或多个神经刺激电极以及在所述一个 或多个电极近端的锚定件,所述锚定件包括沿着引线的长度卷绕的螺旋主体以 及附接至所述螺旋主体向内折叠抵靠引线主体的一个或多个尖齿,螺旋主体受 护套约束210;在所述一个或多个尖齿向内折叠抵靠受护套约束的引线主体时 使引线前进穿过患者的组织到达目标位置212;通过抽回护套来使所述一个或 多个尖齿弹性地展开成从螺旋主体横向地向外延伸的展开构型214;以及通过 将处于展开构型的所述一个或多个尖齿与相邻组织接合由此抑制引线的轴向 运动来将神经刺激引线锚定在目标位置处216。可以通过以下方式来实现引线 移除:向近端抽回引线,直到克服了柔性尖齿提供的锚定力为止。由此,尖齿 由刚度足以提供所期望的锚定力但柔韧到足以避免在被抽回时避免组织损伤 的材料制作。
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 (10)
1.一种神经刺激引线,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多个导体,所述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多个神经刺激电极,所述多个中的每个导体与所述多个神经刺激电极中的相应神经刺激电极相对应;以及
单个锚定件,所述锚定件与所述引线主体耦合并且被配置成用于将所述植入式引线锚定在患者的身体内,其中,所述引线仅包括所述单个锚定件,所述锚定件包括:
螺旋主体,所述螺旋主体在所述引线主体的外侧沿着纵向轴线螺旋状地延伸并且被布置为沿着所述引线主体的凹陷部分,以及
多个尖齿,所述多个尖齿从所述螺旋主体延伸,其中,所述多个尖齿中的每个尖齿被偏置朝向展开构型,其中,在所述展开构型中,所述多个尖齿横向地延伸远离所述纵向轴线,并且所述多个尖齿可弹性偏转朝向递送构型,在所述递送构型中,所述多个尖齿朝向所述纵向轴线向内折叠以便促进在植入期间递送所述神经刺激引线,
其中,所述凹陷部分、所述螺旋主体和所述多个尖齿的尺寸被设定成用于促进在递送和展开时对所述引线进行微调放置。
2.如权利要求1所述的神经刺激引线,其中,所述锚定件被配置成使得:在所述递送构型中,所述多个尖齿中的每个尖齿折叠成抵靠所述引线主体。
3.如权利要求1所述的神经刺激引线,其中,所述锚定件的尺寸被设定成使得:在所述递送构型中,所述锚定件具有与直径为5Fr或更大的护套相兼容的横截面轮廓。
4.如权利要求1所述的神经刺激引线,其中,所述螺旋主体和所述多个尖齿整体地形成。
5.如权利要求1所述的神经刺激引线,其中,所述锚定件由具有足够刚度的材料形成,从而使得,当所述锚定件被植入在所述患者的组织内所述目标位置处时,组织与所述多个尖齿的接合抑制所述引线的轴向运动。
6.如权利要求5所述的神经刺激引线,其中,所述锚定件由肖氏硬度在从50A到80D的范围内的基于聚氨酯的材料模制而成。
7.如权利要求1所述的神经刺激引线,其中,所述锚定件的尺寸被设定成使得:当所述螺旋主体耦合在所述引线主体上时,所述螺旋主体沿着所述引线主体的远端部分延伸范围为从10mm到30mm的长度。
8.如权利要求1所述的神经刺激引线,其中,所述锚定件完全布置在所述多个神经刺激电极的近端。
9.一种神经刺激引线,包括:
可植入引线,所述可植入引线具有引线主体以及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;以及
单个锚定件,所述单个锚定件耦合至所述引线主体,其中,所述锚定件被形成为单个整体部件并且被配置成用于将所述植入式引线锚定在患者的身体内,所述锚定件包括:
螺旋主体,所述螺旋主体沿着所述引线主体的纵向轴线卷绕在所述引线主体的一部分上并且被完全布置在所述引线主体的凹陷部分内,以及
多个尖齿,所述多个尖齿从所述螺旋主体延伸,其中,所述多个尖齿中的每个尖齿横向地向外延伸并且可弹性偏转以便当受护套约束时允许减小轮廓的递送构型,以便促进在植入期间递送所述神经刺激引线,
其中,所述凹陷部分、所述螺旋主体和所述多个尖齿的尺寸被设定成用于促进在递送和展开时对所述引线进行微调放置。
10.一种神经刺激引线,包括:
可植入引线,所述可植入引线具有引线主体以及布置在所述引线的远端处或附近的至少四个神经刺激电极;以及
锚定件,所述锚定件与所述引线主体耦合并且被配置成用于将所述引线锚定在患者的身体内,以便将所述至少四个神经刺激电极维持在目标组织位置处或附近,所述锚定件包括:
螺旋主体,所述螺旋主体沿着所述引线主体的凹陷部分附接至所述引线主体并且沿着其纵向轴线螺旋状地延伸,以及
多个尖齿,所述多个尖齿从所述螺旋主体延伸,其中,当处于展开构型时,所述多个尖齿中的每个尖齿横向地延伸远离所述螺旋主体的纵向轴线,以便促进锚定所述引线,并且其中,所述多个尖齿中的每个尖齿在约束构型中可向内偏转朝向所述引线主体以便允许减小的递送轮廓,从而促进植入所述引线
其中,所述锚定件的尺寸被设定成使得所述螺旋主体的外表面与所述引线主体的在所述凹陷部分之外的外表面基本上齐平,以便提高在展开期间进行的递送和定位的容易性和准确性,从而促进微调引线放置。
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