CN104470580B - 邻近神经组织锚定电极导线的装置和方法 - Google Patents
邻近神经组织锚定电极导线的装置和方法 Download PDFInfo
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Abstract
提供用于神经肌肉电刺激的装置及其锚定方法。所述装置可包括细长构件,所述细长构件具有布置在所述细长构件的远侧区的一个或多个电极和布置在所述细长构件的所述远侧区的至少一个固定元件。所述固定元件可成形和调整尺寸为部署在组织层如肌肉层之间,而不损伤所述组织层,以便将所述一个或多个电极固定在患者体内期望的解剖部位中或附近。附加固定元件可布置在所述细长构件的所述远侧区,以使得组织如肌肉可夹在所述固定元件之间而不损伤所述组织。
Description
发明领域
本申请主要涉及锚定体内医疗器械诸如电刺激导线(lead)、导管或其他大体上细长或管状的器械的装置和方法。
发明背景
许多医疗器械包含需要安置在特定解剖部位的细长或管状的元件。这类器械包括起搏器、脊髓刺激器、周围神经刺激器、和药物递送导管。
在起搏器的例子中,例如,导线可穿过静脉,然后使用导线远端的固定元件来锚定以防止移位。这样的固定元件可以是固定在脑室小梁或肌肉组织中的叉、翅片、或螺钉。
通常,可期望利用微创法植入和锚定医疗器械,且对于许多器械,通过小切口的经皮法更可取。经皮法的一个缺点是,相对较大和复杂的锚定机构无法通过切口或使用针、导管、或套管来部署。此外,在许多情况下,没有医疗器械可以锚定的方便的解剖学结构。
骶神经刺激器导线可包括固定元件如叉,其从导线体伸出以限制导线体相对于周围组织的移动。骶神经导线——如购自Medtronic,Inc.of Fridley,Minnesota的InterStimTM导线——上的叉通常位于距电极相当接近的距离,且仅仅面对一个(近侧)方向。这样的放置允许随着在其中放置叉的肌肉和结缔组织相对刺激目标移动,电极相对移动。
脊髓刺激器(SCS)可包括连接至具有一个或多个电极的一条或多条导线的植入式起搏器(IPG),所述电极被配置以将电能递送至脊髓,以阻止疼痛信号到达脑。电极位置的小变化在一些情况下可负面影响系统有效递送治疗的能力。在脊椎管中提供锚定机构以锚定SCS的导线可能是不实际或不可行的。固定导线的常规技术是使用结扎套管或缝合套管使导线稳定,所述结扎套管或缝合套管被固定至导线体并使用缝合线连接到浅筋膜,如,例如Belden的美国专利号5,957,968和Olson的美国专利号7,930,039中所述。这种技术在普通使用时遭受缺点,包括导线移位的显著发生。另一个缺点是浅表组织经常离刺激的目标组织不期望的距离。患者姿势任何导致浅筋膜和刺激的目标组织之间相对距离改变的改变,导致拉力施加至导线体和随后的电极移动。
Sachs的美国专利申请公开号2008/0228241和Crosby等的美国专利申请公开号2011/0224665,都转让给本发明的受让人,且在本文中都整体以引用的方式并入,描述植入的电刺激器械,所述器械被设计以恢复神经驱动并修复多裂肌以提高脊柱的稳定性。设计这些申请中所述的刺激器系统以重新激活运动控制系统和/或增强稳定脊柱的肌肉,这反过来被预期降低持久性或复发性疼痛,而不是当患者脊柱稳定性潜在经受进一步恶化时掩蔽疼痛信号。Sachs和Crosby还描述周围神经刺激,其中施加电能到神经以影响生理变化,如引起肌肉收缩或阻止疼痛信号在周围神经中传送。
当Sachs和Crosby申请中描述的刺激器系统寻求修复多裂肌并恢复神经驱动时,使用这些系统需要将一条或多条电极导线植入预定解剖部位如脊神经后支的内侧支附近,以引起腰多裂肌的收缩。对于该申请,导线远端附近没有方便的解剖学结构允许在导线上使用常规锚定机构。将导线锚定至如上所述的浅筋膜可在很多情况下有效,但可能仍然容易遭受移位问题,其可阻止正确的治疗递送。
锚定医疗器械的挑战超出电刺激。例如,鞘内泵为配置以将少量和计量量的含有药物的液体递送至目标组织如脊髓的医疗器械。所述药物可以通过放置于脊椎管内的小导管递送,并且移位的问题与以上所述的那些相似。可期望提供机构,其更加有效地锚定导管,以阻止移位和药物错过其指定目标或被递送至不正确部位的可能性。
Cates的美国专利号7,493,175描述使用多叉皮下锚定心脏电极导线的装置。不期望在棘肌内或附近植入这样的装置,因为在运动期间叉可能移位和撕裂肌肉。
Atkinson的美国专利号7,797,053描述在导线远侧部分的系绳和支架样器械,其可在心静脉内扩展以锚定心脏起搏导线。用于神经刺激导线的类似的支架样锚描述于Bly的美国专利号7,917,230中。Lazeroms的美国专利号7,908,015描述皮下放置的刺激导线,其中固定机构包括在导线远端的可移动机构,以使得当啮合以提供锚定时导线直径在远端增加。Morgan的美国专利号8,170,690描述使用螺旋形元件(螺钉)锚定导线。这些先前已知的锚定系统不适于神经肌肉刺激,因为这些系统具有当在肌肉内或附近植入时导线移位的高风险。
可期望提供电极导线和植入方法,其中所述导线牢固地锚定在患者体内,从而降低导线移位的风险。
进一步可期望提供电极导线和植入方法,其中可使用经皮法、针、导管、导线本身、和/或套管来部署锚定机构。
发明概述
本发明通过提供用于神经肌肉电刺激的装置克服先前已知的缺点,所述装置包括具有近侧区和远侧区的细长构件、布置在所述细长构件远侧区的一个或多个电极,和布置在所述细长构件远侧区的第一和/或第二固定元件。所述第一固定元件可成形和调整尺寸为接触但不穿入患者体内的组织(如肌肉、韧带、腱、筋膜),不损伤组织,以便将所述一个或多个电极固定在患者体内期望的解剖部位中或附近。而且,所述第一和第二固定元件可成形和调整尺寸为将患者体内的组织夹在或括在其中间而不损伤组织,以便将所述一个或多个电极固定在患者体内期望的解剖部位中或附近。可选地,所述第一或第二固定元件的至少一个可配置为部署在组织层(例如,肌肉层)之间而不损伤组织层,以便将所述一个或多个电极固定在患者体内期望的解剖部位中或附近。所述固定元件可配置为接触但不穿入组织。
所述一个或多个电极可配置为植入神经组织中或附近。可在细长构件远侧区布置不透射线标记物。例如,不透射线标记物可布置在第一固定元件、第二固定元件、或者两者上或内。第二固定元件可以是螺旋形螺钉。可选地,第一固定元件可相对于细长构件向远侧或近侧形成角度,第二固定元件可相对于细长构件向远侧或近侧形成角度。第二固定元件相对于第一固定元件可布置在细长构件上的远侧,第二固定元件可布置在细长构件的远端。第一和第二固定元件可相对于细长构件的纵轴布置在细长构件的对侧。固定元件可以是可扩展和/或可延伸的。第一和第二固定元件可以是法兰(凸缘,flange)、部分法兰、或分离式法兰。细长构件可具有槽,第一和/或第二固定元件可部分布置在所述槽中,以使第一和/或第二固定元件在槽内围绕细长构件自由旋转。细长构件可具有可在第一和第二固定元件之间的弹性区段。细长构件也可包括在远侧区的不连续部分,其中第一固定元件为暴露于不连续部分中的线圈。装置可进一步包括连接至细长构件近侧区的植入式脉冲发生器和/或植入式微刺激器。
根据本发明的另一个方面,提供锚定具有用于神经肌肉电刺激的一个或多个电极的细长构件的方法。所述方法可包括提供具有布置在细长构件远侧区的固定元件的细长构件,和紧靠组织层(例如,肌肉层)或在组织层之间插入所述固定元件而不损伤组织层,以便将所述一个或多个电极固定在患者体内期望的解剖部位中或附近。
所述一个或多个电极可固定在神经组织例如后支的内侧支中或附近。所述方法可进一步包括使用一个或多个电极将电能递送至后支或其他神经组织。
附图简述
图1显示两节腰椎的前后视图,包括横突间韧带和周围组织。
图2显示两节腰椎的侧视图,包括横突间韧带和周围组织。
图3A和3B描述医疗器械的双向稳定的典型实施方式。
图4显示具有远侧螺旋形螺钉和固定元件的典型电极导线。
图5图解备选电极导线的远侧区,其具有远侧螺旋形螺钉和固定元件。
图6显示典型电极导线的远侧区,其具有在相反方向使用以获得双向稳定的第一和第二固定元件。
图7A至7C描述一些可能的固定元件配置的横剖视图。
图8显示典型电极导线的远侧区,其具有第一和第二固定元件,所述第一和第二固定元件为在两个方向均相互对立并且在导线体对侧上的各自单独突起物。
图9显示与包围横突间韧带的组织放置在一起的图8的电极导线。
图10显示典型电极导线的远侧区,其具有对立的固定元件,其中位于所述固定元件之间的导线被配置为暂时细长。
图11A和11B显示典型电极导线的远侧区,其具有可扩展固定元件,其中所述固定元件在图11A中扩展,在图11B中收缩。
图12A至12C显示部署状态下的典型电极导线的远侧区,其具有用于锚定导线的柔性形状,其中图12A显示蛇形,图12B显示J-形,图12C显示螺旋形。
图12D描述递送状态下图12C的电极导线。
图13显示图12C的电极导线,其部署在紧邻包围横突间韧带的组织。
图14显示典型电极导线的远侧区,其具有在递送状态下的可扩展固定元件。
图15显示图14的电极导线,其具有在部署状态下扩展的固定元件。
图16显示可在图14的电极导线中使用的典型螺纹帽。
图17显示可在图14的电极导线中使用的典型棘轮帽。
图18图解典型电极导线的远侧区,其具有允许组织向内生长的暴露的固定元件。
图19显示典型的植入式微刺激器,其连接至本发明的电极和固定元件。
发明详述
本发明涉及锚定适用于与植入式神经肌肉电刺激("NMES")器械一起使用的电极导线的方法和装置,例如以上并入的Sachs的美国专利申请公开号2008/0228241和Crosby的美国专利申请公开号2011/0224665中所述的。那些申请中所述的器械将电脉冲提供给支配棘肌如多裂肌的神经,并刺激控制那些肌肉的神经以影响被设计以恢复神经控制和修复所述肌肉的治疗。植入式刺激器布置于皮下,并连接至具有电极的一条或多条电极导线,所述电极接触目标肌肉、或支配目标肌肉的神经、或其他与肌肉相关的解剖学结构,如韧带和腱。由刺激器提供的NMES刺激提供与先前已知的脊髓刺激或周围神经刺激治疗器械所用的脉冲状态完全不同的脉冲状态,其中刺激的目标仅仅是减少或阻止疼痛信号传递至患者的脑部,而不是重新激活运动控制系统和/或修复肌肉。
常规锚定机构不适于将NMES电极导线锚定至肌肉和/或介于肌肉层之间,尤其是锚定至棘肌,因为这些肌肉是可移动的,产生导线移位和肌肉损伤的高风险。因此,本发明涉及利用微创或经皮技术使用至少一个固定元件将刺激导线锚定到解剖学结构,例如组织如肌肉中。有利的是,固定元件被调整尺寸和成形以将导线固定至肌肉而不损伤肌肉,以便在患者体内期望的解剖部位例如神经组织中或附近安置一个或多个电极。这样的固定元件可以是法兰、部分法兰、或分离式法兰,其可选地具有配置以最小化肌肉损伤/撕裂的平面和/或光滑表面。所述固定元件为电极导线提供双向稳定且相对于导线可以形成角度或不形成角度。
图1和图2分别显示典型人腰椎的一段的前后投影和侧投影,其具有椎体V、横突TP、横突间韧带ITL、和后支DR。如本文中所述,可锚定本发明装置如电极导线,以便将所述装置固定在期望的解剖学结构例如神经组织中或附近。在一种实施方式中,在后支DR的内侧支中或附近锚定装置,以使得电极可刺激后支DR的内侧支。
图3A和3B图解根据本发明的方面的医疗器械的双向稳定。在图3A中,医疗器械包括细长构件30,其具有布置在细长构件30远侧区33的第一固定元件31和第二固定元件32。第一固定元件31和第二固定元件32成形和调整尺寸为将组织T(例如,肌肉、韧带、腱、筋膜、或其他合适的组织)夹在或括在其中间而不损伤组织T。这样的固定元件可以是法兰、部分法兰、或分离式法兰,其可选地具有配置以最小化肌肉损伤/撕裂的平面和/或光滑表面。第一固定元件31可配置以抵抗向第一方向位移(例如,前进),第二固定元件32可配置以抵抗向第二方向位移(例如,撤回)。示例性地,第二固定元件32相对于第一固定元件31布置在细长构件30上的远侧,且第二固定元件32可布置在细长构件30的远端。
图3B显示本发明医疗器械的备选实施方式,其中细长体34和固定元件35布置在细长体34的远侧区36。通过部署固定元件35来稳定导线体,所述固定元件35被配置以抵抗在组织面内或两个分离的组织面例如肌肉层ML之间的双向位移。
图4图解用于神经肌肉电刺激的典型装置,其具有根据本发明的原理构造的电极导线。装置40包括细长构件41,细长构件41具有固定元件42、螺旋形螺钉43、电极44、和植入式脉冲发生器(IPG)45。固定元件42、螺旋形螺钉43、和电极44布置在细长器械41的远侧区46。固定元件42调整尺寸和成形以将电极固定在期望的解剖部位中或附近。固定元件42可包括聚合物、金属或陶瓷,并配置以抵抗向第一方向移动和在所图解的例子中阻止装置过度的远侧前进,以及向远侧迁移。螺旋形螺钉43被配置以将细长构件41固定至解剖学结构,且可被配置以啮合紧邻细长构件41远侧的组织,形成阻止向第二方向移动的机械锁。通过旋转细长构件41或通过部署在其中螺钉相对于细长构件41旋转的机构,螺旋形螺钉43可锚定至组织,如心脏导线领域已知的。虽然装置示例性地包括螺旋形螺钉43,应该理解可使用的倒刺、钩等也可用作电极的一种。电极44被配置以递送电能,且可以是本领域已知的刺激电极。细长构件41(例如导线)示例性地包括三个电极44,然而公开的范围不限于此。
IPG 45布置在细长构件41的近侧区47。IPG 45可操作地连接至电极44且被配置以指引电极44递送电能。IPG 45可经过导线连接至电极44。可选地,电极可不使用导线而并入植入式微刺激器,如下所述。可包含的IPG 45可包括市场上可提供的微控制器单元,所述微控制器单元包括可编程微处理器、易失性存储器、非易失性存储器(nonvolatile memory)如存储编程的EEPROM、和存储系统操作参数和患者数据日志的非易失性存储器(nonvolatile storage)例如闪存。如本领域普通技术人员将理解的,虽然IPG 45为示例性植入式,脉冲发生器可暂时或永久地布置在患者身体外部,而不偏离本发明的范围。在这种实施方式中,脉冲发生器可通过经皮导线连接至电极。可选地,脉冲发生器和电极可完全在外部,以便导线在合适的位置上施加于皮肤以引起肌肉收缩。
图5图解典型电极导线的远侧区,其具有细长构件51、固定元件52、螺旋形螺钉53、和电极54。固定元件52布置在细长构件51的槽55中,以便固定元件52相对于细长构件51和电极54自由旋转。这样的配置允许部署螺旋形螺钉53而没有固定元件52阻碍旋转或在旋转期间变得不期望地卷入结构如神经中的风险。
图6图解典型电极导线的远侧区,其具有细长构件61、第一固定元件62、第二固定元件63、和电极64。第一固定元件62相对于细长构件61向远侧形成角度,并抵抗向第一方向移动以及在所图解的例子中阻止导线过分插入和向远侧迁移。第二固定元件63相对于细长构件61向近侧形成角度,且穿透组织面并部署在紧邻刺激目标的组织的远侧上。配置第一固定元件62以抵抗相对于第二固定元件63向相反方向移动。这个组合阻止向远侧和向近侧迁移,在旋转中也是。固定元件之间的间距受它们要放置在其周围的结构的限定。在一种实施方式中,间距介于2mm和10mm之间。
图7A至7C图解根据本发明原理的典型固定元件配置。所述固定元件可以由例如聚合物、金属和/或陶瓷制成。所述固定元件可以是法兰、部分法兰、或分离式法兰,其可选地具有配置以最小化肌肉损伤/撕裂的平面和/或光滑表面。所述固定元件为电极导线提供双向稳定,且相对于导线可以形成角度或不形成角度。固定元件可包括任何数量的突起物,通常介于1和8之间。图7A、7B和7C图解医疗器械,其中固定元件分别具有两个突起物71、三个突起物72和四个突起物73。在一种实施方式中,每个突起物的长度介于1mm和5mm之间,且宽度介于0.25mm和2mm之间。
基于邻近刺激目标的解剖学结构和接近所述结构的可用途径,可期望将固定元件定向,以便其最小化为达到合适放置所需的所述结构的尺寸。图8图解电极导线的远侧区,其具有细长构件81、向远侧形成角度的第一固定元件82、向近侧形成角度的第二固定元件83,和电极84。
图9显示图8的电极导线,其放置包围横突间韧带ITL的组织周围以刺激内侧支。在这个配置中,在导线放置期间细长构件81可旋转以使固定元件82和83相对于横突间韧带ITL定向,所述横突间韧带ITL处于与介于临近的横突TP之间的脊柱平行。
图10图解典型电极导线的远侧区,其具有细长构件101、第一固定元件102、第二固定元件103、和弹性部分104。弹性部分104远比细长构件101的主要结构更有弹性,以允许穿入预期的解剖学结构和在所述结构的远侧上部署第一固定元件102。一旦达到,近侧施加的轴向拉力导致弹性部分104伸长达到第二固定元件可部署在预期的解剖学结构近侧上的点。这个配置允许单个设计置于不同厚度的解剖学结构内。弹性部分104将能够伸长达到其固有长度的300%并随后在负载去除之后返回到该固有长度。通过选择具有合适弹性性能的较低硬度聚合物、或通过并入由材料如镍钛金属互化物制成的超弹性弹簧,可获得所述弹性。
图11A和11B图解另一个典型电极导线的远侧区,其具有细长构件111和可扩展固定元件112。在扩展状态下,可扩展固定元件112具有比细长构件111显著更大的直径。图11A显示扩展状态下的可扩展固定元件112,图11B显示收缩状态下的可扩展固定元件112。在一个实施方式中,使用允许通过标准技术放置的连接至细长构件111近端的真空装置收缩可扩展固定元件112。一旦细长构件111的远端穿过预期的结构,去除真空装置,可扩展固定元件112回到如图11A所示的原始尺寸。这种安排克服了通常与扩展结构如用于固定的气球相关的挑战,因为典型的气球需要持续的压力来保持膨胀。与使用正压力来增加直径相反的采用真空装置来减小直径有效减轻了这些类型的结构中长期稳定性的疑虑。
图12A至12C显示在部署状态下典型电极导线的远侧区,其具有用于锚定导线的柔性形状,其中图12A显示蛇形电极导线121,图12B显示J-形电极导线122,图12C显示螺旋形电极导线123。通过预制期望形状的导线体,或并入保持这种形状的组件,或同时通过两者,可获得这种形状。该形状在性质上可以是三维或二维的,且可以是一致节距或可变节距。在导线放置期间通过插入通管丝或其他硬化元件,该形状可变直,然后导线体在没有硬化元件时将松弛成为锚定形状。
图12D描述递送状态下图12C的电极导线。金属线125如通管丝的引入,引起远端124变直。然后,导线123可放置在期望的位置。在放置之后,去除金属线125,远端124回到其固有状态,啮合期望的解剖学结构,示例性地为肌肉M,并提供在第一和第二方向两者上的稳定,如图13所示。
本发明进一步提供有效部署固定元件的实施方式,如图14和15中所示。图14描述典型电极导线的远侧区,其具有在递送状态下显示的可扩展固定元件。电极导线包括细长构件141、帽142、螺母143、和可扩展固定元件144。帽142布置在细长构件141的远端。帽142的近端与螺母143连接,螺母143也连结至细长构件141,但是在更近侧。在帽142和螺母143之间,细长构件141被切开,允许可扩展固定元件144以可预见的方式变形。在部署电极导线时,驱使帽142近侧通过细长构件141内的螺母143。这有效地缩短142和143与细长构件141的连结点之间的距离,以导致可扩展固定元件144凸出。可定位这些凸出,以便在组织面内或两个相邻的组织面之间提供稳定。
图16图解用在图14的电极导线中的典型帽。帽161包括外螺纹162、挡块163、和开口164。螺纹被配置以与图14螺母上的螺纹相配合。旋转螺母内的帽161驱使二者在一起,引起部署。配置帽161远端的开口164以接受通管丝,所述通管丝配有设计以与164相配合并允许传递扭矩的末端。帽161也可包括挡块163,其被设计以阻止过度的部署并固定两个组件相对于彼此的位置。
图17图解用于图14的电极导线中的备选的帽。帽171包括悬臂172,悬臂172包括线性排列的外齿173,外齿173被配置为螺母上的内齿相配合。金属线175啮合到帽171中,允许将金属线175近侧拉入螺母中,使二者通过相吻合的齿锁在一起。可选地,金属线175可以是预先设置长度的缝合线,其用来使两个组件通过反牵引结合在一起。然后,缝合线超出的长度将被剪去并放置于器械头部内。该机构可通过插入通管丝去除,所述通管丝包含与悬臂172前缘斜面176相配合的远侧特征。向内施加到臂172上的压力将使齿轮脱离并允许帽171向远侧移动。
图18图解典型电极导线的远侧区,其具有细长构件181、电极182、和固定元件183。示例性地,一个电极182布置在固定元件183的远侧,另一个电极182布置在固定元件183的近侧,尽管如本领域普通技术人员将理解的,本发明的范围不限于此。固定元件183可以是连接至远侧电极(一个或多个)182的至少一个绝缘金属线的导体线圈。金属线可与连接到细长构件181中其它电极182的一个或多个其它导体共同缠绕,且金属线长度的大部分可被包围在细长构件181绝缘管中。导线使用可拆卸连接器连接至IPG,或使用熟悉本领域的人员熟知的典型构造永久地连接至IPG。如所图解的,固定元件183可暴露其长度的一部分,例如在电极182之间,在此细长构件181的一部分是不连续的。所暴露的线圈段提供用于组织向内生长(如瘢痕组织)的脚手架,组织向内生长降低了电极182移动的风险或将其阻止。在急性期(在组织向内生长之前),所暴露的电极的几何结构(例如,不光滑侧)提供充分的锚定以降低导线移位或移动的风险或将其阻止。在植入期间,本领域普通技术人员熟知构造的锁定通管丝可用来锁定到电极182的至少一个,以在手术过程中提供结构强度。有利地,细长构件181、导线、和固定元件183是等直径的,允许通过针或导引器使用经皮技术植入和直接复位。通过使用与电极182的至少一个啮合的锁定通管丝可去除导线,从而提供结构强度。可选地,通过在导线外部上沿其整个长度滑动导管可去除导线,这是可能的,因为导线体是等直径的。
图19显示本发明的另一个方面,其中固定元件(一个或多个)和电极(一个或多个)连接至植入式微刺激器。示例性地,器械包括连接至在近侧区193的微刺激器192的细长构件191,和在远侧区197的电极194、第一固定元件195和第二固定元件196。微刺激器192可操作地连接至电极194并被配置以指引电极194递送电能。可以与在例如Loeb的美国专利号6,735,474或Perryman的美国专利申请公开号2012/0283800中所述的刺激器相似地配置微刺激器192。微刺激器192可以是可注射的、用手术放置或经皮放置,且可以是内部驱动或外部驱动的,例如,凭借将动力通过射频(RF)或微波传递至微刺激器192的外部动力来源。微刺激器192可以固定至组织T(例如,肌肉、韧带、腱、筋膜、或其他合适的组织),以便将一个或多个电极194布置在患者体内期望的解剖部位中或附近。示例性地,使用与图6的第一固定元件62和第二固定元件63相似的第一固定元件195和第二固定元件196可以锚定器械。然而,如本领域普通技术人员将理解的,固定元件31、32(图3A)、35(图3B)、42、43(图4)、具有槽55的52和53(图5)、82、83(图8)、具有弹性部分104的102和103(图10)、112、(图11A-11B)、144(图14)、和/或183(图18)可连接至植入式微刺激器,没有偏离本发明的范围。
在图19中,示例性地,第一固定元件195被布置在组织T的近侧以降低通过组织面的进一步前进的风险或将其阻止,第二固定元件196被布置在组织T的远侧以降低微刺激器192和电极194撤回(移位)的风险或将其阻止。
软辫线(pigtail)198可以可去除地连接至微刺激器刺激器。软辫线198也可包括一个或多个沿其长度布置的电极,以在刺激配置或参数的选择中提供柔性。在一种实施方式中,第一固定元件195和第二固定元件196连接至软辫线198。在这种实施方式中,细长构件191、微刺激器192和电极194具有纵向通过的腔,以使得软辫线198可穿过所述腔。在实施中,具有第一固定元件195和第二固定元件196的软辫线198通过递送机构(例如,导向金属线、针、通管丝等等)前进到组织T,并且第一固定元件195和第二固定元件196被固定至组织T。接着,软辫线198的近端穿过腔,细长构件191、微刺激器192和电极194沿着软辫线198的长度滑动,直到电极192安置在期望的解剖部位中或附近。软辫线198可包括单向锁定机构(例如,叉)(未显示),以使得随着细长构件191、微刺激器192和电极194在锁定机构上向远侧移动,腔可在锁定机构上滑动。一旦细长构件191、微刺激器192和电极194布置在锁定机构的远侧,锁定机构启动(例如,扩展)以阻止细长构件191、微刺激器192、和电极194近侧移动越过锁定机构,以保持微刺激器192在期望的位置并且电极194在期望的解剖部位中或附近。
尽管本公开中描述的医疗器械示例性地为电极导线,但是医疗器械可容易包括备选的医疗器械,如导管或其他大体上为管状的医疗器械。此外,尽管将固定元件描述为配置以锚定到肌肉或肌肉层,但是锚可容易地配置为锚定到任何提供稳定位置的合适的解剖学结构,如韧带、关节囊、纤维膜、腱、筋膜等。
当然应该理解,本发明的范围中提供通过电刺激可激活多裂肌的组织如后支神经的内侧支来提供多裂肌的双边刺激。进一步应该理解,多水平如后支L3、L4和L5的内侧支,可受导线刺激以最大限度地训练多裂肌。虽然后支神经被描述为用于刺激的目标神经,但是在本专利的范围内,一种或多种其它解剖学结构,如韧带、腱、筋膜、和/或除脊柱稳定肌肉(例如,腹横肌、腰肌、棘间肌、最长肌、髂肋肌、横突间肌、方肌)外的神经的刺激可包括适当治疗。
虽然以上描述了本发明的各种示例性实施方式,但是在其中可作出各种改变和改进而不偏离本发明对本领域技术人员来说是显而易见的。所附的权利要求旨在覆盖所有这些落入本发明真实范围内的改变和改进。
Claims (17)
1.用于神经肌肉电刺激的装置,所述装置包括:
具有近侧区和远侧区的细长构件;
布置在所述细长构件的所述远侧区上的一个或多个电极;
布置在所述细长构件的所述远侧区上的第一固定元件,所述第一固定元件包括第一聚合物法兰,所述第一聚合物法兰被配置以在插入组织之后部署到相对于所述细长构件向远侧形成角度的位置,所述第一聚合物法兰被成形和调整尺寸以抵抗所述细长构件在第一方向移动;和
在所述第一固定元件远侧所述细长构件上布置的第二固定元件,所述第二固定元件包括第二聚合物法兰,所述第二聚合物法兰被配置以部署到相对于所述细长构件向近侧形成角度的位置并且抵抗所述细长构件在第二方向移动;
其中所述第一方向与所述第二方向相反以便所述第一和第二固定元件阻止所述组织移动过程中所述细长构件向远侧、向近侧和以旋转迁移,从而将所述一个或多个电极固定在患者体内支配一个或多个棘肌的神经组织中或附近,和
其中所述第一和第二固定元件被成形和调整尺寸以将所述组织夹在其之间,以便将所述一个或多个电极固定在所述患者体内支配所述一个或多个棘肌的神经组织中或附近。
2.权利要求1所述的装置,其中所述一个或多个电极配置为植入神经组织中或附近。
3.权利要求1所述的装置,其进一步包括布置在所述第一固定元件上或内的不透射线标记物。
4.权利要求1所述的装置,其中所述第一固定元件包括介于1-8个之间的突起物。
5.权利要求1所述的装置,其中所述第一固定元件和第二固定元件之间的间距介于2mm和10mm之间。
6.权利要求1所述的装置,其中所述第一聚合物法兰包括部分法兰或分离式法兰。
7.权利要求1所述的装置,其中所述细长构件包括弹性区段。
8.权利要求1所述的装置,其中所述第一固定元件具有被配置以最小化肌肉损伤的平面和/或光滑表面。
9.权利要求1所述的装置,其进一步包括连接至所述细长构件的所述近侧区的植入式脉冲发生器。
10.权利要求1所述的装置,其中所述第一固定元件被成形和调整尺寸为部署在肌肉层之间而不损伤所述肌肉层。
11.权利要求1所述的装置,其中所述一个或多个电极中的至少一个被布置在所述细长构件上的所述第一和第二固定元件之间。
12.权利要求1所述的装置,其中所述组织包括肌肉。
13.权利要求1所述的装置,其中所述第一和第二固定元件被配置以将肌肉层夹在其之间。
14.权利要求1所述的装置,其中所述第一和第二固定元件被成形和调整尺寸以夹住所述组织以便将所述一个或多个电极固定在后支的内侧支中或附近。
15.权利要求1所述的装置,其中所述第一固定元件包括介于1mm和5mm之间的长度和介于0.25mm和2mm之间的宽度。
16.权利要求1所述的装置,其中所述第二固定元件包括介于1mm和5mm之间的长度和介于0.25mm和2mm之间的宽度。
17.权利要求1所述的装置,其进一步包括在所述近侧区连接至所述细长构件的植入式微刺激器。
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