CN103079489B - 用于减少迁移的方法、***和装置 - Google Patents
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Abstract
提供了用于减少导线、导管和类似装置的迁移的装置、***和方法。特别是,提供了用于建立松紧锚定物有助于将导线或导管保持在所需位置中的松紧锚定物的装置、***和方法。在一些实施方式中,所述松紧锚定物建立在硬膜外腔内松紧锚定物。当神经解剖目标在脊柱内或在硬膜外腔周边时,锚定在硬膜外腔内使得相关的导线或导管根据需要或尽可能地靠近目标治疗位点锚定。通过靠近目标治疗部位锚定,显著地降低或消除了移动或迁移的风险。
Description
相关申请的交叉参考
本申请根据35U.S.C.119(e)要求2010年5月10日提交的题为“Methods,Systemsand Devices for Anchoring in the Epidural Space”的美国临时专利申请No.61/333199的优先权,该专利申请通过引用结合于此。
对于在联邦赞助研究和开发下进行发明的权利的声明
不适用
在光盘上提交的“序列表”、表格或计算机程序列表附录的说明
不适用
发明背景
神经调节是通过利用可植入装置治疗性地改变疼痛路径的活性来治疗疼痛症状的方法。神经调节通过主动地用电能刺激神经以产生天然生物应答或者通过将小剂量的靶向药剂直接施用到作用部位而起作用。
电刺激涉及将电极施加到患者的大脑、脊髓或外周神经。这些准确放置的电极通常被安装在连接到脉冲发生器和电源的导线上,其产生必要的电刺激。低压电流从发生器传递到神经,并且可抑制疼痛信号或刺激神经冲动(这些神经冲动此处先前是不存在的)。电刺激的最常见类型之一是脊髓刺激(SCS),其自20世纪60年代以来已被用作患有慢性疼痛的患者的治疗选项。在过去的30年中,它已成为患有背部和/或四肢的慢性疼痛的患者的标准治疗,这些患者没有从其他治疗方法感到疼痛缓解。而该治疗并不能对每个人发挥作用,许多适合于神经刺激治疗的患者的全身疼痛缓解了。有些患者发现,经过脊髓刺激后他们可以减少疼痛的药物治疗。鉴于这些优点,许多患有慢性疼痛的患者发现神经刺激确实提高了他们的生活质量。
在某些情况下,可选地神经调节可以通过经植入的导线或导管递送药学剂来实现。以这种方式,药物可以较小剂量施用,因为这些药物在到达目标区域之前不是必须经过代谢和传送通过身体。较小剂量(口服剂量的1/300的范围内)可能意味着较少的副作用,提高的患者舒适性以及改善的生活质量。
然而,神经调节并不是没有其风险和并发症。与导线的植入相关的一种并发症是导线的迁移,其随着时间可能会导致有效刺激的损失。在迁移过程中,刺激电极,通常在导线的远侧末端,相对于神经发生移动,因而产生不太希望的刺激效应。传统SCS导线定位在硬膜外腔内,这是主要地不受限制的区域。此外,这些导线通常锚定在硬膜外腔外,如锚定到棘上韧带上方的筋膜上或锚定到棘上韧带本身上。因此,该导线对于锚定远端的部分自由地沿导线的整个长度从锚定点到尖端以任何方向在硬膜外腔内自由移动。这样的运动可以改变导线的位置以使得刺激随着时间发生改变或甚至无效。类似地,在定位在硬膜外腔内的导管也可能遭受迁移动导致药剂递送到目标位置以外的问题。
导线的移动或迁移可由以下因素引起:1)身体动作(弯曲、扭转等),2)从导线的近侧部分(即从锚定点、IPG连接点或者筋膜或韧带)传导到导线远侧末端的张力,3)导线本身的重力沉降和/或4)其他因素。防止迁移的锚定或其他装置用于防止或减少由于这些原因引起的导线远侧末端的运动。
希望的是改善导线和导管的锚定。这种锚定是无创的以避免损坏或伤害患者的解剖结构(特别是精细的神经组织),且在某些情况下,应该是可逆的以允许校正***而无需直接达到硬膜外腔而移除导线。这些目标中的至少一些将被本发明所满足。
本发明的发明内容
本发明提供了用于减少导线、导管和类似装置的迁移的装置、***和方法。特别是,提供了用于建立有助于保持导线或导管在期望的位置的松紧锚定物的装置、***和方法。在一些实施方式中,松紧锚定物建立在硬膜外腔内。当靶向于位于脊柱内或在硬膜外腔附近的神经解剖结构时,锚定在硬膜外腔内允许相关的导线或导管如所希望地或尽可能地接近目标治疗位点地被锚定。通过接近于目标治疗位点进行锚定,移动或迁移的风险被显著减少或消除。
本文所描述的装置、***和方法通常用于治疗疼痛。治疗通常包括电刺激和/或药剂或其它试剂利用导线或导管递送到目标神经位点。为了例证说明的目的,本文将要描述的实施例是使用导线向背根或背根神经节(DRG)提供电刺激来治疗疼痛。然而,可以理解,本发明可被用于治疗其他病症,如瘙痒、帕金森氏病、多发性硬化症、脱髓鞘运动障碍、脊髓损伤、哮喘、慢性心脏衰竭、肥胖和中风(特别是急性局部缺血)、外周血管疾病或心绞痛,仅举几例。同样地,本发明可用于锚定靶向于其他治疗位点的装置,其他治疗位点如脊髓本身、后根入髓区(DREZ)、任何可通过硬膜外腔达到的位点和/或任何允许在硬膜外腔内建立松紧锚定物的位点。另外,本发明可以用来锚定靶向于外周神经的装置。在这样的实施方式中,装置如导线或导管可以不经过硬膜外腔,且松紧锚定物可以在体内靠近目标外周神经形成。另外,本发明可以用于锚定任何具有允许建立松紧锚定物的特征的装置。
在本发明的第一个方面中,提供了一种建立松紧锚定物的方法。在一些实施方式中,该方法包括:定位具有远侧末端和轴的导线,以使得远侧末端定位在目标位置处并且轴沿第一路径延伸;在轴上推进具有弯曲的远侧末端的护套;操控护套以使得弯曲的远侧末端指引所述轴的一部分横向于第一路径;推进导线超出指引轴的该部分横向于第一路径的弯曲的远侧末端,使得轴的该部分沿第二路径驻留,从而形成松紧锚定物而同时基本上保持远侧末端的位置在目标位置处。在一些实施方式中,在硬膜外腔内形成松紧锚定物。
在一些实施方式中,所述第二路径具有蛇形形状。在其它实施方式中,第二路径具有环形形状。可以理解的是,在一些实施方式中,目标位置包括背根神经节。在这样的实施方式中,可以在靠近背根神经节附近的脊柱内的位置形成松紧锚定物。然而,导线可以定位以靶向于其他解剖结构,并且松紧锚定物可以在其他位置形成。
在一些实施方式中,松紧锚定物产生足够的摩擦以抵抗远侧末端相对于目标位置的迁移。在其它实施方式中,轴的迁移运动至少部分由松紧锚定物吸收以抵抗远侧末端相对于目标位置的迁移。
在本发明的第二方面中,提供了一种在硬膜外腔内定位导线的方法。在一些实施方式中,该方法包括:将导线的远侧末端从入口点推进到硬膜外腔内达到目标位置以便导线的轴的一部分在硬膜外腔内沿第一路径从入口点延伸到目标位置;将导线轴的另外部分引入硬膜外腔中,其方式使得在目标位置和入口点形成松紧锚定物。
在一些实施方式中,松紧锚定物产生足够的摩擦以抵抗远侧末端相对于目标位置的迁移。在其它实施方式中,轴的迁移运动至少部分地由松紧锚定物吸收以抵抗远侧末端相对于目标位置的迁移。
在一些实施方式中,引入另外部分包括沿第二路径定位导线轴的另外部分,其中所述第二路径的至少一部分横向于所述第一路径。可以理解,在某些情况下松紧锚定物具有蛇形形状,且在其他情况下,松紧锚定物具有环形形状。在一些实施方式中,该轴包括扭结点以使得引入轴的另外部分导致轴靠近扭结点弯曲,这有助于建立松紧锚定物。
在一些实施方式中,在硬膜外腔内定位导线的方法还包括将具有弯曲的远侧末端的护套在轴的该部分上推进,从而使弯曲的远侧末端指引另外部分的引入。任选地,所述方法还包括操控弯曲的远侧末端以指引该另外部分沿与第一路径基本横向的方向引入。在某些情况下,目标位置包括背根神经节。在这种情况下,松紧锚定物可以在靠近背根神经节的脊柱内的位置形成。
在本发明的第三方面中,提供用于处理目标位置的装置。在一些实施方式中,该装置包括含有轴的导线,该轴具有沿其远侧末端布置的至少一个电极和沿该轴靠近该至少一个电极布置的结构扭结点,以便该结构扭结点驻留在硬膜外腔内而同时该至少一个电极靠近目标位置定位,其中当轴的一部分推进到硬膜外腔中同时所述至少一个电极的位置基本上保持在目标位置附近时,所述结构扭结点有助于建立松紧锚定物。
在一些实施方式中,结构扭结点包括材料刚性的变化。在这样的实施方式中,结构扭结点可以包括在较刚性区域的远端布置的柔性区域。例如,该轴可以由至少一个管构成,且较刚性区域可以由该至少一个管的灌封形成。
在一些实施方式中,导线的远侧末端配置用于靠近背根神经节定位该至少一个电极。任选地,可以布置结构扭结点,从而建立邻近于与背根神经节相关的背根的松紧锚定物。在一些实施方式中,松紧锚定物具有蛇形形状。在其它实施方式中,松紧锚定物具有环形形状。本发明的其他目的和优点将结合附图从以下详细描述中变得清楚。
附图简要说明
图1表示可利用松紧锚定物的示例刺激***。
图2A-2D表示了用于达到目标位点和建立松紧锚定物的示例导线和递送装置。
图3表示在导线的轴上推进的护套实施方式,具有形成第一曲率的内部管心针。
图4表示导线,其中图3的内部管心针延伸超过护套形成第二曲率。
图5A-5D表示建立松紧锚定物方法的实施方式。
图6表示包含单个之字形的具有蛇形形状的松紧锚定物的实施方式。
图7表示包含多个之字形的具有蛇形形状的松紧锚定物的实施方式。
图8表示具有不规则形状的松紧锚定物的实施方式。
图9表示具有环形形状的松紧锚定物的实施方式。
图10表示包括各种蛇形和环形形状的松紧锚定物的实施方式。
图11表示具有松紧锚定物的导线的实施方式,其已用逆行方式定位。
图12表示具有由细长的尖端形成的松紧锚定物的导线的实施方式。
图13表示包含具有刚性不同的区域的轴的导线的实施方式。
图14A-14B表示使用图13的导线建立松紧锚定物的方法的实施方式。
具体实施方式
图1表示可以利用用于锚定导线100(例如锚定在患者的硬膜外腔内)的松紧锚定物的示例刺激***10。在该实施方式中,刺激***10包括导线100(其具有布置于其上的至少一个电极102)和可植入脉冲发生器(IPG)112。导线100包括具有近侧末端105和远侧末端106的轴103。近侧末端105可***IPG 112中以提供与导线100的电连接。IPG 112包含处理器114、天线115、存储器116中的可编程刺激信息以及电源118(例如电池),以使得一旦编程并接通,IPG 112可独立于外部硬件操作。IPG 112被接通和断开,并被编程以便使用经皮的电磁或RF连接从外部编程装置产生所需的刺激脉冲。刺激信息包括信号参数,例如电压、电流、脉冲宽度、重复率和猝发传输率(burst rate)。示例的刺激信息由2009年10月27日提交的题为“Selective Stimulation Systems and Signal Parameters ForMedicalConditions”的美国专利申请No.12/607009提供,其为所有目的并入本文作为参考。
所希望的导线100靠近目标位点如DRG的定位和松紧锚定物的建立可以用多种递送***、装置和方法实现。参照图2A-2D,显示了用于达到目标位点并建立松紧锚定物的示例导线和递送装置。图2A显示导线100的实施方式,包括具有远侧末端101的轴103,在其上布置有四个电极102。可以理解的是,可以存在任何数目的电极102,包括一个、两个、三个、四个、五个、六个、七个、八个或更多。在本实施方式中,远侧末端101具有末端闭合的远侧尖端106。远侧尖端106可以有多种形状,包括圆形形状,例如球形(如图所示)或泪滴形状和锥形和环形,仅举几个例子。这些形状为导线100提供防止创伤的尖端以及用于其他目的。导线100还包括朝着末端闭合的远侧尖端106延伸的管心针腔104。还示出了递送***120,包括护套122(图2B)、管心针124(图2C)和引入针126(图2D)。
参照图2B,显示护套122的实施方式。在本实施方式中,护套122具有预先弯曲成具有角度α的远侧末端128。在一些实施方式中,角度α在大约80-165度的范围内。护套122被设置大小并配置成在导线100的轴103上推进,直到其远侧末端128的一部分邻接导线100的远侧尖端106,如图3所示。因此,此实施方式的球形尖端106还防止护套122在其上延伸。护套122在导线100上经过造成导线100按照护套122的预定曲率弯曲。因此,当接近目标DRG时,护套122有助于导引导线100沿着脊髓S和朝着目标DRG转向,例如沿横向转向。
再参照图2C,显示了管心针124的实施方式。管心针124具有预先弯曲的远侧末端130。在一些实施方式中,预定曲率具有在大约0.1-0.5的范围内的曲率半径。管心针124被设置大小并配置成在导线100的管心针腔104内推进。通常,管心针124延伸穿过以使得其远侧末端130与导线100的远侧末端101对齐。管心针124通过导线100导致导线100按照管心针124的预定曲率弯曲。通常,管心针124具有比护套122小的曲率半径或较紧的弯曲部。因此,如图4所示,在管心针124布置在导线100内时,导线100和管心针124通过护套122延伸使得导线100弯曲或指引导线100经过第一曲率123。导线100和管心针124进一步延伸超出护套122的远侧末端128允许导线100进一步沿着第二曲率125弯曲。当接近目标DRG时,这允许横向指引的导线100现在沿着神经根向目标DRG而弯曲。这种两步弯曲允许导线100成功定位,从而使得至少一个电极102在目标DRG上、其附近或周围,特别是通过沿神经根形成急弯。
因此,导线100不需要刚性或耐扭转的构造,这是由于导线100本身不扭转或转向。导线100利用指引导线100经过两步曲率的护套122和管心针124来定位。这消除了操作者扭转导线100本身的需要并允许导线100具有较低的型面以及非常柔软和柔性的构造。一旦导线100被植入,这继而最小化侵蚀和由在神经组织例如目标DRG和/或神经根上的压力产生的不适。例如,这种柔软和柔性导线100将最小化由身体运动(例如屈曲、伸展、扭转)传递到导线100的尖端的力的大小,这随之减小了导线相对于目标组织的位置变化。
再参照图2D,显示了引入针126的实施方式。引入针126用来达到脊髓S的硬膜外腔。针126具有中空轴127,并通常具有很轻微地弯曲的远侧末端132。轴127的尺寸设置成允许导线100、护套122和管心针124从其中通过。在一些实施方式中,针126是14号,这与用来在硬膜外腔内放置传统经皮导线的硬膜外针的尺寸一致。但是,可以理解的是,也可以使用其他尺寸的针,特别是较小的针,例如16-18号。同样,可以理解的是,也可以使用具有各种本领域技术人员已知的尖端或设计用于特定应用的常规尖端的针。针126还通常包括Luer-LokTM接头134或者靠近其近侧末端的其他接头。Luer-LokTM接头134是母接头,其具有接合公接头例如注射器上的套筒内的螺纹的带凸起的套节。
在一些实施方式中,上述导线100和递送***120被用来建立松紧锚定物。图5A-5D显示使用上述导线100和输送***120建立松紧锚定物的方法。在本实施方式中,导线100从顺行的途径被输送到DRG。各DRG沿背根DR分布,并通常至少部分驻留于椎弓根轴PD之间或位于椎间孔内。各背根DR以θ角离开S。这个角度θ被认为是神经根套管角,并随病人和随沿着脊髓的位置而略有变化。在许多情况下,神经根角明显小于90度,且有时小于45度。因此,导线100以这种方式向目标DRG推进涉及形成沿θ角的急弯。使用递送***120完成这种程度的弯。
在该实施方式中,使用引入针126进入硬膜外腔。一旦引入针126成功地***硬膜外腔中,导线100被输送到目标DRG,如图5A所示。管心针124被***到导线100中,且护套122在导线100上推进。定位护套122以使得其远侧末端128与导线100的远侧尖端106接近或抵靠导线100的远侧尖端106,导致导线100跟随护套122的远侧末端的曲率。利用护套122的预定曲率在硬膜外腔内向目标DRG推进组合的护套122/导线100/管心针124,从而侧向地向外指引导线100。然后推进导线100/管心针124超过护套122的远侧末端128。导线100内的管心针124的曲率使导线100沿着这一曲率进一步弯曲。这使得侧向指引的导线100现在沿神经根角朝目标DRG弯转。这两步的弯曲使导线100成功地转向以定位至少一个电极102在目标DRG上面、附近或周围。这些递送方法由2010年1月14日提交的题为“Stimulation Leads,Delivery Systems and Methods of Use”的美国专利申请No.12/687,737进一步描述并阐明,其为所有目的并入本文作为参考,连同适用于本发明的其它递送***、装置和方法的实施例。
因此,导线100的远侧末端101定位在目标位置处,且轴103沿第一路径延伸。然后护套122和管心针124缩回,留下沿第一路径延伸的导线100的柔性轴103。参看图5B,操控护套122以使得弯曲的远侧末端128指引轴103的一部分横向于硬膜外腔内的第一路径。图5B显示指引轴103的一部分横向向外远离脊髓S的中线的护套122。然而,可以理解,护套122可以旋转,以便指引轴103的一部分横向向内朝向脊髓S的中线。同样地,可以操控护套122,以便面向多种其他方向。
参照图5C,然后导线100推进超出护套122的弯曲的远侧末端128。由于管心针124被缩回,导线100的轴103是非常柔软的,特别是与护套122相比。护套122的较刚性的远侧末端128指引柔性轴103的一部分横向于第一路径以便柔性轴103的这一部分沿第二路径驻留。因此,在护套122和导线100的轴103之间的刚度或柔性的差异产生“扭结点”或弯曲区域,从而允许轴103转折和弯曲。弯曲导线100的这一部分形成松紧锚定物。因此,导线100的曲率提供松紧部分和/或锚定。松紧部分吸收硬膜外腔内导线100的任何移动或迁移,并防止或最小化相对远侧末端101这种移动。这使得远侧末端101保持其位置,并继续为目标位点提供期望的刺激。由硬膜外腔内导线100的弯曲产生的摩擦力和由松紧部分产生的增加表面积建立锚定。松紧部分和锚定显著减少或消除硬膜外腔内导线迁移的风险。
可以理解,使用管心针124可替代地或附加地形成松紧锚定物。在此类实施方式中,在导线100的轴103内将管心针124推进超出护套122的远侧末端128以达到所需位置。沿管心针124驻留的区域,管心针124为轴103提供增加的刚性。因此,管心针124终止于轴103内的位置建立自然扭结点,从而使轴103转折和弯曲。因此,管心针124可以操控以沿导线100的轴103在任何需要的位置建立多种弯曲。
在常规的脊髓刺激中,SCS导线可以无需递送护套而输送,或者导线不使用赋予刚性的递送护套输送。同样地,导线本身具有一致的刚性。如果没有产生刚性差异的装置,则不能产生扭结点并因此不能容易地形成松紧锚定物。
在本发明中,可以通过操控护套122和/或管心针124形成多种不同的松紧锚定物。一旦所需的松紧锚定物建立,则移除护套122和管心针124,而导线100被留在原位,如图5D所示。由于松紧锚定物布置在硬膜外腔内,导线100被尽可能靠近目标治疗位点如DRG锚定。在该实施例中,在与背根邻近的沿脊髓的位置处形成松紧锚定物。通过靠近目标治疗位点锚定,导线100的远侧末端102移动或迁移的风险显著减少或消除。当在与目标治疗位点相同的脊髓水平上或在邻接或靠近目标治疗位点的脊髓水平上进入硬膜外腔时,这种锚定是特别有用的。在这些情况下,进入位点和目标治疗位之间的距离是相对短的,这增加了迁移的风险。因此,松紧锚定物的使用特别可用于在这些情况中抵抗迁移。
本发明的松紧锚定物可以具有多种形状或形式。在一些实施方式中,松紧锚定物装置具有蛇形形状。在这样的实施方式中,导线100的轴103通过一个或多个之字形弯曲,如S形、蛇形或Z字形。该之字形可以是短的,如形成波浪形状,或是长的,如形成叶片形状。此外,之字形的数目可以是最小的,如一个或两个,或更多个。图6显示具有包含单一之字形300的蛇形形状的松紧锚定物的实施方式。在这里,导线100的远侧末端101靠近DRG定位且轴101沿神经根角和沿脊髓的部分延伸。如果导线100不包括松紧锚定物,则轴103沿朝向硬膜外腔的进入点延伸的第一路径驻留。然而,在该实施方式中,轴103沿具有蛇形形状的第二路径定位,其形成松紧锚定物。图7表示具有包含多个之字形300的蛇形形状的松紧锚定物的实施方式。在该实施方式中,存在4个之字形300。各个之字形300是相对长的以便形成叶片形状。
在一些实施方式中,松紧锚定物具有不规则的形状,例如多种形状的组合。例如,图8表示具有不规则形状的松紧锚定物的实施方式。在这里,导线100的远侧末端101定位在DRG的附近且轴101沿神经根角延伸到脊髓S的脊骨区域。再者,如果导线100不包括松紧锚定物,轴103沿朝向硬膜外腔的进入点延伸的第一路径驻留。然而,在该实施方式中,轴103沿具有不规则形状的第二路径定位,形成松紧锚定物。第二路径包括蛇形形状,其中轴103延伸通过两个小的之字形300。然后第二条路径在朝向入口点延伸前延伸跨越硬膜外腔,从而形成大的之字形或叶片形300′。在该实施方式中,松紧锚定物延伸跨越脊髓S的宽度从而提供显著的松紧程度和锚定能力。
在一些实施方式中,松紧锚定物具有环形形状。例如,图9表示具有环形形状的松紧锚定物的实施方式。在这里,环形形状是通过产生穿过其自身而形成环302的之字形形成。如图9所示,导线100的远侧末端101定位在DRG附近,且轴101沿神经根角延伸到脊柱中。轴101沿第一路径开始,且然后沿具有环形形状的第二路径延伸。在该实施方式中,环302从脊髓S中线延伸离开。然而,可以理解的是,在一些实施方式中,环302朝脊柱S的中线延伸。同样地,可以理解的是,可以存在任何数目的环302并且环302可以是任何尺寸。
在一些实施方式中,松紧锚定物具有蛇形和环形形状的组合。例如,图10表示由各种蛇形和环形形状构成的松紧锚定物的实施方式。在本实施方式中,松紧锚定物包括至少四个环302,其中的一些环302跨越构成基础的之字形300。因此,导线100的轴103遵循形成松紧锚定物的复杂的路径。
在一些实施方式中,松紧锚定物配置为形成松紧锚定物后允许从硬膜外腔无创伤地移除导线100。硬膜外腔由流体和纤维***构成。随着时间在导线100周围形成纤维组织,从而产生硬膜外腔内的生物结构。导线100的路径基本上是通过该生物结构的通道或通路,因此导线100能够自由移动,并因此能够迁移。然而,本发明的松紧锚定物由该生物结构支持,使得通道或通路遵循松紧锚定物路径的弯曲和轮廓。由于松紧锚定物路径是非直线的,如蛇形,导线100由该生物结构保持在适当位置并减少迁移。此外,如果需要移动导线100,可以通过轻轻拉动导线100的近侧末端从硬膜外腔抽出导线100,直到导线100被移除。随着松紧锚定物路径的弯曲和轮廓,导线100可以移动通过通道或通路。可以利用抽取的力实现这种移动,但是这种移动不能通过单纯的迁移力来实现。可以理解的是,在一些实施方式中,松紧锚定物配置为保持作为永久性锚定物,其中导线100不易在周围的生物结构形成后移除。这种松紧锚定物通常是卷曲的或复合的,从而使得导线100不易通过所述路径抽出。
可以理解,尽管上述的硬膜外递送方法显示了可通过硬膜外腔达到目标位点的顺行途径,但也可以使用多种其它的方法。例如,可以使用逆行、对侧或经椎间孔的途径,仅举几例。图11显示通过逆行途径定位的导线100的实施方式。在这里,目标位点是DRG,且定位导线100以使得所述至少一个电极位于DRG的附近区域中。因此,导线100的远侧末端101沿背根DR延伸并进入脊髓S的区域(其中松紧锚定物由导线100的轴103形成)中。在该实施方式中,松紧锚定物由两个之字形300组成。用这种途径定位的导线100由松紧锚定物的存在获得极大的益处,因为导线100的第一路径通常基本上是直线的,这对于迁移可具有非常小的抗性。
图12显示以经椎间孔/椎间孔外途径定位的导线100的实施方式,其中DRG从脊柱的外侧接近。在本实施方式中,导线100具有细长的远侧尖端350,以使得远侧尖端350延伸到脊髓S的区域中,而同时至少一个电极102驻留于DRG的附近区域中。在这里,由细长的远侧尖端350形成松紧锚定物以在硬膜外腔内锚定导线100。这种松紧锚定物可由任何上述的技术来形成,如使用护套122和/或管心针124。
也可以理解,本发明的松紧锚定物可以由2009年5月15日提交的题为“Methods,Systems and Devices for Delivering Stimulation to SpinalAnatomy”的美国临时专利申请No.61/178847提供的导线和装置形成,其为所有目的并入本文作为参考。同样地,本发明的松紧锚定物可用于锚定使用本文描述的方法定位的此类导线和装置。
在一些实施方式中,改变的导线400被用于建立松紧锚定物。在这些实施方式中,导线400包括有助于建立松紧锚定物的结构扭结点或弯曲区域。例如,在一些实施方式中,结构扭结点包含几何特征,如V型缺口。在其他实施例中,扭结点包括材料刚性的变化。例如,在一些实施方式中,导线400包含具有刚性差异的区域的轴402,如图13中所示。在这里,轴402包括布置在较刚性区域406(用阴影表示)之间的柔性区域404。由于柔性区域404是将要在其内形成松紧锚定物的区域,柔性区域404通常位于至少一个电极408近侧并靠近至少一个电极408。因此,至少一个电极408将被锚定靠近目标刺激位点。
图14A显示靠近目标治疗位点(在本情况中为DRG)定位的图13的导线。在本实施方式中,导线400由对侧途径输送到DRG。使用引入针426达到硬膜外腔并且导线400朝向目标DRG推进,以使得至少一个电极408理想地相对于目标DRG定位。因此,导线400的远侧末端401被定位在目标位置,且轴402沿第一路径延伸。参看图14B,由于近侧较刚性区域406的刚性,轴402然后通过引入针426沿第一路径推进。然而,由于其间的柔性区域404,这种力没有明显转移到导线400的远侧末端401,且柔性区域404沿第二路径(其通常包括横向于第一路径的部分)弯曲或转折。因此,柔性区域404形成松紧锚定物并阻止运动转递到导线400的远侧末端401。这有助于锚定和防止导线迁移。
可以理解,以这种方式形成松紧锚定物而不需使用护套和/或管心针通常是较少控制的方法。在柔性区域中形成的转折和弯曲通常是与解剖环境结合的导线配置的产物,其中使用者对松紧锚定物的实际形状具有较少控制。与此相反,如上所述使用护套和/或管心针形成松紧锚定物允许使用者详细控制松紧锚定物的各自轮廓。
沿导线400的材料刚性的变化(例如相对于图13描述和表示的)可由多种方法或技术产生。在一些实施方式中,导线400具有如2010年1月14日提交的题为“StimulationLeads,Delivery Systems andMethods of Use”的美国专利申请No.12/687,737描述和显示的构造,该文献为所有目的通过引用并入本文。特别地,在一些实施方式中,导线100的轴402包括由挤出聚合物如聚氨酯形成的单管腔管构成。另外的元件,如电缆和任选的拉伸元件,通过该单管腔管延伸。在这样的实施方式中,轴402用较硬的材料灌封以产生导线400的较刚性区域406。当轴402由软硬度的材料如聚氨酯(例如Bionate,Pellethane)或聚硅氧烷构成时,灌封材料由具有相对较高的刚性的材料如环氧树脂(例如Epotek)构成。将灌封材料注入或沉积到单管腔管中从而环绕在其中延伸通过元件,并使其硬化。该灌封材料增加了其中进行沉积的区域中的导线400的刚性。因此,可以在沿导线400的任何地方形成特定的较刚性区域406。在一些实施方式中,导线400在除松紧锚定物在其内形成的区域以外的所有区域中被灌封。在其它实施方式中,导线40从近侧灌封,从而使导线最远侧末端不灌封并更柔性。例如,在其中导线400的长度约为40厘米的一些实施方式中,导线400的最近侧的30厘米被灌封。
可以理解,导线400的特定部分,如远侧末端401,可预形成弯曲,从而更容易地达到DRG(特别是通过顺行途径)。灌封区域的预弯曲可以在其中的灌封材料硬化之前通过预弯曲轴402实现,以使得硬化的灌封材料设定预定曲率。当不使用护套或管心针输送导线400时,这种预弯曲可能是有用的。此外,在这样的实施方式中,导线400可以不包括减小外径(如最高约25-40%)的管心针腔。这种直径的减小可提高达到特定解剖结构的能力,特定解剖结构如缩窄的椎间孔开口或外周神经。
在其它实施方式中,用可布置的固化聚合物在操作中填充轴402以形成导线400的较刚性区域406。再次,在一些实施方式中,导线100的轴402由挤出聚合物如聚氨酯形成的单管腔管构成。另外的元件,如电缆和任选的拉伸元件,通过该单管腔管延伸。在这样的实施方式中,轴402被注以聚合物或其它固化的材料以形成导线400的较刚性区域406。这种固化的材料提高了导线400在其所沉积的区域中的刚性。由于该材料在操作中填充,使用者能够根据患者的特定解剖结构和手术过程的详情确定较刚性区域406的所需位置。因此,松紧锚定物的位置和构造可以针对患者精确地个性化。
可以理解,也可以通过多种其他的方法或技术替代地产生沿导线400的材料刚性的变化。例如,轴402的壁可以在较刚性区域406中强化,如通过更高硬度的材料、强化编织物或直丝复合材料(straight wirecomposite)、与第二刚性材料共挤压、包覆模制、或壁的增厚,仅举几例。同样地,轴402可以由多种材料构成,各种材料具有不同的硬度。例如,轴402在较刚性区域406中可以由具有较高硬度的单管腔管构成和在柔性区域404中由刚性较低的单管腔管构成。有几种硬度标度,各用于具有不同性能的材料。最常见的两种标度(使用稍有不同的测量***)是ASTM D2240A型和D型标度。A型标度用于较软的塑料,而D型标度用于较硬的塑料。然而,ASTM D2240-00测试标准要求总共12个标度,这取决于预定的用途:A、B、C、D、DO、E、M、O、OO、OOO、OOO-S和R型。各个标度产生在0到100之间的值,数值越高,表示材料越硬。因此,使用值差异很大的材料(如“C”硬度为55和70)可以用于形成根据本发明的扭结点。
在其他实施方式中,沿导线400的材料刚性的变化通过可分离的管心针产生。在这样的实施方式中,管心针首先用于帮助定位导线400,如上所述。一旦导线400已经按需要定位,管心针即被分离、分割、分开或拆开以使得在导线400内留下管心针的一部分,从而形成较刚性区域406。从其中移除管心针的区域形成柔性区域404。例如,在一些实施方式中,管心针延伸至导线400的远侧尖端或其附近,其中的管心针可在相对远侧尖端近侧的位置分离。管心针然后回拉所需的距离以形成柔性区域,可形成松紧锚定物。然后管心针的剩余部分驻留于该柔性区域的近侧,以便形成具有材料刚性的变化的导线,如图13中所示。然后可以建立松紧锚定物,如根据类似于图14A-14B中所示的方法的方法。可以理解,管心针可以在多个位置处是可分离的,以便形成各种模式的较刚性区域406。也可以理解,管心针可用于产生材料刚性的目的而用于定位导线。
类似地,在一些实施方式中,沿导线400的材料刚性的变化是由可分离的护套产生的。在这样的实施方式中,护套首先用于帮助定位导线400,如上所述。一旦导线400已经按需要定位,护套即被分离、分割、分开或拆开,以使得沿导线400留下护套的一部分,从而形成较刚性区域406。从中移除护套的区域形成柔性区域404。例如,在一些实施方式中,护套延伸至导线400的远侧尖端的附近、电极的近侧,其中护套在相对于护套远侧末端的近侧位置处是可分离的。护套然后回拉所需的距离以形成柔性区域,形成松紧锚定物。然后护套的剩余部分驻留于该柔性区域的近侧。然后可以建立松紧锚定物,如根据类似于图14A-14B中所示的方法的方法。可以理解,护套可以在多个位置处是可分离的,以便形成各种模式的较刚性区域406。也可以理解,护套可用于产生材料刚性的目的而不用于定位导线。
可以理解,本文所描述的装置、***和方法可用于减少靶向于神经***的任何部分的导线中的导线迁移。可以定位导线以便刺激中枢神经***的部分,如脊髓、脊髓神经和脑。同样,可以定位导线以便刺激外周神经***的部分。特别地,可以如2011年4月7日提交的题为“Devices,Systems and Methods for Modulation of the Nervous System”的美国临时专利申请No.61/473,132中所述定位导线,其为所有目的并入本文作为参考。为了降低在这些导线位置的任何位置中导线迁移的可能性,可以根据本文描述的任何方法沿导线形成松紧锚定物。这种松紧锚定物可以定位在硬膜外腔内。或者可以在硬膜外腔外形成松紧锚定物。在一些实施方式中,当在硬膜外腔以外的组织中建立松紧锚定物时,使用多种空间生成技术在组织中创建虚拟空间,如使用扩展器(expander)、牵开器(retractor)、解剖器(dissector)、隧穿工具(tunnellingtool)和吹注器(insufflator),仅举几例。然后在虚拟空间内建立松紧锚定物,从而提供应变释放和锚定能力,其有助于保持导线的远侧末端的位置靠近目标组织。在其他实施方式中,当在硬膜外腔外的组织中建立松紧锚定物时,利用天然存在的空间定位松紧锚定物于其中。
虽然出于清楚理解的目的,通过图解和实施例详细描述了本发明,显而易见的是可以使用多种替代方式、变型和等同方式,并且以上描述不应该被认为是限制通过所附权利要求限定的本发明的范围。
Claims (15)
1.用于治疗目标位置的装置(10),包括:
导线(100,400),其包括轴(103,402),该轴具有沿其远侧末端(104,401)布置的至少一个电极(102,408)和沿所述轴在该至少一个电极近端布置的结构扭结点,使得所述结构扭结点驻留于硬膜外腔内而所述至少一个电极定位在所述目标位置附近,
其中当所述轴的一部分推进到硬膜外腔中同时该至少一个电极的位置基本保持靠近所述目标位置时,所述结构扭结点帮助建立松紧锚定物。
2.根据权利要求1所述的装置,其中所述结构扭结点包括材料刚性的变化。
3.根据权利要求2所述的装置,其中所述结构扭结点包括相对于较刚性区域(406)远端布置的柔性区域(404)。
4.根据权利要求3所述的装置,其中所述轴(402)由至少一个管构成且所述较刚性区域(406)通过该至少一个管的灌封形成。
5.根据权利要求1所述的装置,其中所述导线(100,400)的远侧末端(104,401)配置用于将该至少一个电极(102,408)定位在背根神经节附近。
6.根据权利要求5所述的装置,其中所述结构扭结点被布置以建立邻近于与背根神经节相关的背根的所述松紧锚定物。
7.根据权利要求1所述的装置,其中所述松紧锚定物具有蛇形形状。
8.根据权利要求1所述的装置,其中所述松紧锚定物具有环形形状。
9.根据权利要求1所述的装置,其中所述轴(402)的远侧末端(401)被预形成弯曲。
10.根据权利要求1所述的装置,其中所述目标位置包含背根神经节。
11.根据权利要求2所述的装置,其中所述结构扭结点包含布置在两个较刚性区域(406)之间的柔性区域(404)。
12.根据权利要求2所述的装置,其中所述材料刚性的变化是由沿所述轴的材料硬度的差异所导致。
13.权利要求3或11所述的装置,其中所述轴(402)的一部分被配置以被用可布置的固化聚合物在操作中填充以形成所述较刚性区域(406)。
14.权利要求3或11所述的装置,其中所述轴(402)包含壁,所述壁的一部分被强化以形成所述较刚性区域(406)。
15.权利要求14所述的装置,其中所述壁被通过更高硬度的材料、强化编织物或直丝复合材料、通过与第二刚性材料共挤压、或通过包覆模制或壁的增厚来强化。
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WO2011143233A2 (en) | 2011-11-17 |
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CA2798961A1 (en) | 2011-11-17 |
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