CN104519946B - 用于电刺激系统的具有端头电极的导线及其制造和使用方法 - Google Patents
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Abstract
一种可植入式电刺激导线,其具有布置在导线主体的远端头的端头电极。一个端头电极具有基座以及附接于基座的分离插头。基座界定出内腔,并且内腔一端通过插头封闭。另一个端头电极具有电极主体、从电极主体延伸出来的柄体、以及从柄体延伸出来的带有形状的保持特征。另一个端头电极具有电极主体、从电极主体延伸出来的柄体,以及附接于柄体并且朝向电极主体相反侧的凸缘。另一个端头电极具有电极主体,并且电极主体界定出内腔和延伸进入内腔的多个突起。另一个端头电极具有电极主体,以及从电极主体延伸出来的多个臂。该电极主体界定出内腔,并且所述多个臂延伸越过通向内腔的开口。
Description
相关申请的交叉引用
本申请要求享有申请号为61/654,759,申请日为2012年6月1日的美国临时专利申请的优先权,该专利申请的全部内容通过引用方式合并在本申请中。
技术领域
本发明涉及的领域是电刺激系统及制造和使用该系统的方法。本发明还涉及具有端头电极的电刺激导线,其被设计成便于将端头电极保持在该导线的远端,并且还涉及制造和使用该导线和电刺激系统的方法。
技术背景
电刺激可以用于治疗多种病症,深脑刺激可以用于治疗例如帕金森氏病、肌张力障碍、特发性震颤、慢性疼痛、亨廷顿氏舞蹈病、左旋多巴诱发的运动障碍和僵硬、运动徐缓、癫痫症和发作、进食失调、以及情绪障碍。典型地,具有在导线端头处或在导线端头附近的刺激电极的导线向脑中的目标神经元提供刺激。磁共振成像(MRI)或计算机化断层显象(CT)扫描可以提供起始点,用于确定所述刺激电极应被置于何处以向该目标神经元提供所希望的刺激。
在导线植入患者的脑中后,刺激电流沿着所述导线上的选定电极输送以刺激脑中的目标神经元。通常,该电极以环形的形式被布置在所述导线的远端部上。该刺激电流从环形电极均匀地沿着各个方向发射。由于该电极的环形形状,该刺激电源不能导向环形电极周围的一个或多个特定位置(如在该导线周围的一个或多个侧面或位点)。因此,未经导向的刺激可能会导致邻近神经元组织不希望的刺激,并且有潜在可能地产生不期望的副作用。
发明内容
一个实施例是一种可植入式电刺激导线,其包括具有远端部、远端头和近端部的导线主体;沿着该导线主体的该远端部布置的多个电极;沿着该导线的该近端部布置的多个端子;以及多个导体,各个导体将至少一个电极与至少一个端子电耦联。多个电极包括布置在该导线主体的该远端头的端头电极。该端头电极具有基座以及附接于该基座的分离插头。该基座界定出内腔,并且内腔一端通过该插头封闭。该导体主体的一部分延伸进入该基座的该内腔中。
另一个实施例是一种可植入式电刺激导线,其包括具有远端部、远端头和近端部的导线主体;沿着该导线主体的该远端部布置的多个电极;沿着该导线的该近端部布置的多个端子;以及多个导体,各个导体将至少一个电极与至少一个端子电耦联。多个电极包括布置在该导线主体的该远端头的端头电极。该端头电极具有电极主体,从该电极主体延伸出来的柄体,以及从该柄体延伸出来的多个带有形状的保持特征。该导线主体的一部分围绕该柄体和带有形状的保持特征延伸。该带有形状的保持特征有助于将该端头电极保持在该导线主体上。
另一个实施例是一种可植入式电刺激导线,其包括具有远端部、远端头和近端部的导线主体;沿着该导线主体的该远端部布置的多个电极;沿着该导线的该近端部布置的多个端子;以及多个导体,各个导体将至少一个电极与至少一个端子电耦联。多个电极包括布置在该导线主体的该远端头的端头电极。该端头电极具有电极主体,从该电极主体延伸出来的柄体,以及附接于该柄体并且朝向该电极主体相反侧的凸缘。该导线主体的一部分围绕该柄体和凸缘延伸。该凸缘有助于将该端头电极保持在该导线主体上。
另一个实施例是一种可植入式电刺激导线,其包括具有远端部、远端头和近端部的导线主体;沿着该导线主体的该远端部布置的多个电极;沿着该导线的该近端部布置的多个端子;以及多个导体,各个导体将至少一个电极与至少一个端子电耦联。多个电极包括布置在该导线主体的该远端头的端头电极。该端头电极具有电极主体,并且该电极主体界定出内腔和延伸进入该内腔的多个突起。该内腔中的多个突起有助于将该端头电极保持在该导线主体上并且防止该端头电极绕着该导线主体的该远端头转动。
另一个实施例是一种可植入式电刺激导线,其包括具有远端部、远端头和近端部的导线主体;沿着该导线主体的该远端部布置的多个电极;沿着该导线的该近端部布置的多个端子;以及多个导体,各个导体将至少一个电极与至少一个端子电耦联。多个电极包括布置在该导线主体的该远端头的端头电极。该端头电极具有电极主体,以及从该电极主体延伸出来的多个臂。该电极主体界定出内腔以及通向该内腔的开口。多个臂延伸越过通向该内腔的该开口。该导线主体的一部分延伸进入该电极主体的该内腔并且围绕多个臂。多个臂有助于将该端头电极保持在该导线主体上。
附图说明
参考附图描述本发明的非限制性的和非穷举性的实施例。在附图中,除非另外明确说明,同样的参考标号贯穿各个附图以指示同样的部件。
参考下面的详细描述以更好地理解本发明,并且结合附图来阅读,其中:
图1是根据本发明,用于脑刺激设备的一个实施例的侧面示意图;
图2是根据本发明,一部分导线实施例的立体示意图,该导线具有多个分段的电极以及端头电极;
图3是根据本发明,一部分导线的第二实施例的立体示意图,该导线具有多个分段的电极以及端头电极;
图4是根据本发明,沿着导线长度方向按照各种电极层级控制的径向电流的示意图;
图5是根据本发明,两片式端头电极实施例的截面示意图;
图6A是根据本发明,带有两片式端头电极的一部分导线的实施例,在将两片端头电极联接起来之前的侧视示意图;
图6B是根据本发明,图6A中带有两片式端头电极的一部分导线,在将两片端头电极联接起来之后的侧视示意图;
图7是根据本发明,一带有柄体的端头电极一实施例的截面示意图;
图8A是根据本发明,带有柄体和凸缘的端头电极一实施例的立体示意图;
图8B是根据本发明,半成品电极一实施例的立体示意图,其可以被打磨以形成图8A中的端头电极;
图9A是根据本发明,端头电极一实施例的立体示意图,其包含有形状的内腔;
图9B是根据本发明,半成品电极一实施例的立体示意图,其可以被打磨以形成图9A中的端头电极;
图10A是根据本发明,端头电极一实施例的立体示意图,其带有内腔以及从电极的边缘延伸越过内腔开口的多个臂;以及
图10B是根据本发明,半成品电极一实施例的立体示意图,其可以被打磨以形成图10A中的端头电极。
具体实施方式
本发明涉及的领域是电刺激系统以及制造和使用该系统的方法。本发明还涉及具有端头电极的电刺激导线,其被设计成便于将端头电极保持在该导线的远端,并且还涉及制造和使用该导线和电刺激系统的方法。
用于深脑刺激的导线可以包括刺激电极、记录电极或两者的组合。在至少一些实施例中,导线的刺激或记录电极可以包括端头电极和一个或多个环形电极或分段的电极或其组合。在至少一些实施例中,刺激电极、记录电极或两者的组合中的至少一些电极以分段的电极的形式存在并且只延伸于导线圆周的局部。在一些实施例中,这些分段的电极可以以成组电极的形式存在,每组电极径向地布置在导线上并且位于特定的纵向位置。在一些实施例中,分段的电极可以有其他合适排列方式,如将分段的电极沿导线圆周的一个或多个螺旋线布置或将分段的电极只沿导线的一侧布置。
从业人员可以使用记录电极确定目标神经元的位置,然后在不取下记录导线以及植入刺激导线的情况下安放刺激电极。在一些实施例中,同样的电极可以用于记录也用于刺激。在一些实施例中,可以使用分开的导线;一根导线带有能识别目标神经元的记录电极,以及第二导线带有刺激电极,在识别确认目标神经元后该第二导线替换第一导线。导线可以具有围绕着导线圆周间隔设置的记录电极,以确定目标神经元的位置。在至少一些实施例中,在使用记录电极将神经元定位后,导线可转动从而刺激电极可以与目标神经元对准。为了清楚描述的目的,参照深脑刺激的应用来描述这里的导线,但应理解的是任何导线都要可以用于除了深脑刺激的其他应用,包括但不限于脊髓刺激、背根神经节刺激以及其他神经、肌肉组织或器官的刺激。
深脑刺激设备以及导线已被描述在专利申请中,例如美国专利7,809,446;美国专利申请公开2007/0150036、2009/0187222、2009/0276021、2010/0076535、2010/0268298、和2011/0078900;以及美国专利申请12/177,823、61/022,953、和61/316,759。这些参照申请各自以引用方式合并在在本申请中。
图1示出了一个用于脑刺激的设备100的实施例。该设备包括导线110、至少局部地围绕着导线110圆周设置的多个电极125、多个端子135、用于电极和控制单元连接的连接器130,用于向患者脑中植入和定位导线的探针140。探针140可以由刚性材料制成。探针的合适材料例如包括但不限于钨、不锈钢和塑料。探针140可以具有把手150,以协助于植入导线110,以及探针140和导线110的转动。连接器130装配在导线110的近端上方,优选地,在去除探针140之后。
控制单元(未示出)典型地可以是植入患者体内如患者锁骨区域下方的可植入脉冲发生器。脉冲发生器可以具有8个刺激信道,其可以独立地编程以控制来自各个信道的电流刺激的强度。在一些例子中,脉冲发生器可以具有8个以上的刺激通道(如16、32或更多个刺激通道)。控制单元可以具有一个、两个、三个、四个或更多个连接器端口,以用于接收导线110的近端的多个端子135。
在操作的一个例子中,到达脑中的期望位置可以通过如下方式来实现:即用颅骨钻(通常被称为钻孔器)在患者的头骨或头盖骨中钻洞,以及凝结和切割硬脑膜,或脑覆盖。导线110可以在探针140的辅助下被插入到头盖骨和脑组织中。导线110可以使用例如立体定向架和微动马达系统引导到脑内的目标位置。在一些实施例中,微动马达系统可以是完全地或部分地自动的。微动马达系统可以构造成为执行一个或多个下列动作(単独的或组合的):植入导线110、收回导线110或转动导线110。
在一些实施例中,耦联到被目标神经元刺激的肌肉或其他组织的测量设备,或者响应于患者或临床医生的单元,可以耦联到控制单元或微动马达系统。测量设备、用户或临床医生可以指示出由目标肌肉或其他组织对刺激或记录电极的响应,以进一步识别目标神经元以及帮助定位刺激电极。例如,如果目标神经元意在肌肉经历震颤,则测量设备可以用于观察肌肉,并且指示出响应于神经元的刺激而发生的震颤频率或幅度中的变化。可替代地,患者或临床医生可以观察肌肉并且提供反馈。
用于深脑刺激的导线110可以包括刺激电极、记录电极或两者的组合。在至少一些实施例中,导线110是可转动的,这样在使用记录电极将神经元定位之后,刺激电极可以与目标神经元对准。
刺激电极可以布置在导线110的圆周上以刺激目标神经元。刺激电极可以是环形形状,这样各个电极从电极的位置沿导线110的长度朝向各个方向均匀地发射电流。然而,环形电极一般不能使刺激电流仅导向导线的一侧。而分段的电极,可以将刺激电流导向导线的一侧,或者甚至是导线一侧的一部分。当分段的电极与输送恒定电流刺激的可植入脉冲发生器一起使用时,可以实现更精确的电流控制,以将刺激输送至导线中心轴周围的位置(如导线中心轴周围的径向位置)。
为了达到电流的控制,在环形电极基础上,可以附加地或替代地使用分段的电极。尽管下列描述讨论的是刺激电极,但应理解的是,所讨论的刺激电极的所有配置也可以适用于记录电极的布置。
图2和图3示意了实施例中用于脑刺激的导线200的远端部。导线200包括导线主体210、一个或多个任选的环形电极220、多个分段的电极230、和端头电极240。应理解的是,其他实施例的导线可以只包括端头电极和一个或多个环形电极,或只包括端头电极和一个或多个分段的电极。其他实施例可以包括端头电极以及不同于图2和图3所示的排布方式的环形电极和分段的电极的组合。
导线主体210可以由可以由生物相容的非导电材料例如聚合材料形成。合适的聚合材料包括但不限于聚硅氧烷、聚氨酯、聚脲、聚氨酯-脲、聚乙烯或类似物。一旦植入体内,导线200可以长期与身体组织相接触。在至少一些实施例中,导线200具有不大于1.5mm的横截面直径并且可以处于1至I.5mm的范围内。在至少一些实施例中,导线200具有至少10cm的长度,并且导线200的长度可以在25至70cm的范围内。
电极220、230、240可以由金属、合金、导电氧化物,或任何其它合适的导电生物相容材料来制造。合适的材料的例子包括但不限于钼、钼铱合金、铱、钛、或钨。优选地,这些电极由这样的材料制成:该材料是生物相容的并且在预期的使用持续时间、在预期的操作环境中的操作条件下实质上不腐蚀。
各个电极220、230、240可以使用或不使用(关闭)。当使用电极时,电极可以用作阳极或阴极并且携带阳极或阴极电流。在一些情况中,电极可以在一段时间是阳极并且在另一段时间是阴极。
以环形电极220形式存在的刺激电极可以布置在导线主体210的任何部位,通常是邻近导线200的远端。以端头电极240形式存在的刺激电极布置在导线的远端。在图2中,导线200包括一个环形电极220和一个端头电极240。可以沿着导线主体210的长度布置任意数量的环形电极220,例如布置一个、两个、三个、四个、五个、六个、七个、八个、九个、十个、十一个、十二个、十三个、十四个、十五个、十六个或更多个环形电极220。应理解的是,可以沿着导线主体210的长度布置任意数量的环形电极220。
在一些实施例中,环形电极220和端头电极240基本呈圆柱形并且包围着导线主体210的整个圆周。端头电极240也延伸越过导线的末端。在一些实施例中,环形电极220和端头电极240的外径各自基本上等于导线主体210的外径。环形电极220和端头电极240的长度可以根据所期望的治疗和目标神经元或其他组织的位置而各自有变化。在一些实施例中,环形电极220和端头电极240中的一个或多个电极的长度小于或等于对应的环形电极220和端头电极240的直径。在其它的实施例中,环形电极220和端头电极240中的一个或多个电极的长度大于对应的环形电极220和端头电极240的直径。在至少一个实施例中,端头电极240和其中一个环形电极220的表面积可以大致相同(如彼此差别在10%以内或5%以内)。
深脑刺激导线和其他导线可以包括一组或多组分段的电极。分段的电极可以比环形电极提供更优异的电流控制,这是因为深脑刺激中的目标结构一般不会相对于远端电极阵列的中心轴呈对称排列。相反地,目标可能位于通过导线中心轴的平面的一侧。通过使用径向分段的电极阵列(RSEA),不仅可以实现沿着导线长度的电流控制,还可以实现沿导线圆周的电流控制。这就提供了精准的三维目标对准并且将电流刺激输送至神经目标组织,而潜在地避免了对其他组织的刺激。具有分段的电极的导线的例子包括美国专利8,295,944和8,391,985,以及美国专利公开2010/0268298、2011/0005069、2011/0078900、2011/0130817、2011/0130818、2011/0238129、2011/0313500、2012/0016378、
2012/0046710、2012/0165911、2012/0197375、2012/020331、2012/0203320和2012/0203321,上述所有内容以引用方式合并在本申请中。
在图2中,示出的导线200具有多个分段的电极230。任意数量的分段的电极230可以布置在导线主体210上,例如布置一个、两个、三个、四个、五个、六个、七个、八个、九个、十个、十一个、十二个、十三个、十四个、十五个、十六个或更多个分段的电极230。应理解的是,可以沿着导线主体210的长度布置任意数量的分段的电极230。
分段的电极230可以划分成多组分段的电极,每组电极布置在导线200的圆周周围并且位于特定的纵向部分上。导线200可以在指定的某组分段的电极中具有任意数量的分段的电极230。导线200可以在指定某组中具有一个、两个、三个、四个、五个、六个、七个、八个或更多个分段的电极230。在至少一些实施例中,导线200的各组分段的电极230包含同样数量的分段的电极230。布置在导线200上的分段的电极230可以与布置在导线200上的至少一组其他分段的电极230具有不同的数量的电极。
分段的电极230的尺寸和形状可以变化。在一些实施例中,分段的电极230具有全部相同的尺寸、形状、直径、宽度或面积或其任何组合。在一些实施例中,沿着圆周的每组分段的电极230(或者甚至是布置在导线200上的所有分段的电极)可以在尺寸和形状上一致。
每组分段的电极230可以围绕导线主体210的圆周布置以形成围绕导线主体210的基本上圆柱形的形状。导线200上指定一组分段的电极的各个电极之间的间隔可以与另一组分段的电极的各个电极之间的间隔相同或不同。在至少一些实施例中,围绕导线主体210的圆周的每个分段的电极230之间布置有相等的间隔、缝隙或切口。在其它实施例中,分段的电极230之间的间隔、缝隙或切口可以在尺寸或形状上不同。在其它实施例中,对于特定的某组分段的电极230或者对所有组分段的电极230,分段的电极230之间的间隔、缝隙或切口可以是一致的。这些组分段的电极230可以沿导线主体210的长度以不规则的或规则的间隔布置。
连接到端头电极240、环形电极220和分段的电极230的导体电线沿着导线主体210延伸。这些导体电线可以延伸穿过导线200或者沿着导线200界定的一个或多个内腔延伸,或者两者都有。该导体电线存在于连接器处(通过端子),以用于将电极220、230、240耦联到控制单元(未示出)。
当导线200包括端头电极240、环形电极220和分段的电极230时,环形电极220和分段的电极230可以以任何合适的构造排布。端头电极240一般会位于包含该端头电极240的任何排布的远端。例如,当导线200包括端头电极240、环形电极220和两组分段的电极230时,端头电极240和环形电极220可以位于两组分段的电极230的两侧(如图2所示)。可替代地,端头电极240和环形电极220可以布置在远离两组分段的电极230的位置(如图3所示)。应理解的是,也可以有其他的可能的构造(如环形和分段的电极交替排列,或类似的布置方式)。
端头电极240、环形电极220和分段的电极230的任意组合都可以布置在导线200上。例如,导线可以包括环形电极、两组分段的电极,各组由三段式电极230形成、以及位于导线一端的端头电极。这种构造可以是图2所示的1-3-3-1的构造。用这种简化的标记来指示这些电极可能是方便的。图3示出具有3-3-1-1构造的导线。具有端头电极的16电极导线的可能构型包括但不限于3-3-3-3-3-1和1-3-3-2-3-3-1。
可以设置记号或标记,这样从业者可以确定植入时的分段的电极的方向。合适的记号或标记可以在以上这些文献中找到,如美国专利公开2012/0016378和2012/0203321,以及美国专利申请13/750,725和13/787,171,上述所有内容以引用方式合并在本申请中。
图4示出了沿导线200的长度按照各个电极级控制的径向电流的示意图。虽然具有环形电极的传统导线构造只能沿着导线的长度(z-轴)控制电流,但分段的电极的构造能够在x-轴、y-轴以及z-轴上控制电流。因此,可以在环绕所述导线200的三维空间中在任何方向上控制刺激的形心。在一些实施例中,围绕所述导线体110的圆周的径向距离r和角度θ可以由引入到每个电极的阳极电流(认识到刺激主要在阴极附近发生,尽管强阳极也可以导致刺激)的百分比规定。在至少一些实施例中,阳极和阴极沿分段的电极130的构造允许刺激的重心沿导线200偏移到各种不同的位置。
如可以从图4中理解的是,刺激的重心沿导线200的长度可以在每个级(level)上偏移。沿导线200的长度在不同的级上使用多组分段电极130允许三维电流控制。在一些实施例中,共同地偏移这些组的分段电极230(即,刺激的重心沿导线的长度在每个级是相似的)。在至少一些其他实施例中,每组分段电极230可以受独立地控制。每组分段电极可以包含两个、三个、四个、五个、六个、七个、八个或更多的分段电极。应理解的是,可以通过改变在每个级上的分段电极数量来产生不同的刺激形态。例如,当每组分段电极仅包括两个分段的电极时,可以在刺激分布中形成均匀分布的缝隙(不能选择性地刺激)。在一些实施例中,在一组中使用至少三个分段的电极230以允许真正的360°的选择性。
如先前所指出的,当使用记录电极时也可以使用前面的构造。在一些实施例中,耦联到被目标神经元或单元刺激的肌肉或其他组织的测量设备,或者响应于患者或临床医生的单元,可以耦联到控制単元或微动马达系统。测量设备、用户或临床医生可以指示出由目标肌肉或其他组织对刺激或记录电极的响应,以进一步识别目标神经元并帮助定位刺激电极。例如,如果目标神经元意在肌肉经历震颤,则测量设备可以用于观察肌肉,并指示出响应于神经元的刺激而发生的震颤频率或幅度中的变化。可替代地,患者或临床医生可以观察肌肉并提供反馈。
端头电极可以与一个或多个环形电极、一个或多个分段的电极、或环形以及分段的电极的任意组合一起使用。在至少一些实施例中,端头电极可以选择与导线的一个或多个环形电极具有相同的或大致相同的表面积。
端头电极可以被设计以改进端头电极在导线上的保持性能。例如,端头电极可以具有中空柱状基座和可以附接于基座的分离的插头。图5示出具有基座542和分离插头544的端头电极540。基座542和分离插头544通常由合适的金属、合金或其他导体形成。基座542为带有内腔541的中空管状结构,管状结构的两个相反端具有开口,以允许物料从基座流过。开放的内腔541帮助将基座保持在导线上。基座542具有远端开口543,其形状被调整以用于接收插头544。在一些实施例中,基座542在远端开口543处具有斜边545,以与插头544的斜边547对应,从而帮助将基座和插头匹配。应理解的是,也可以用其它构造的远端开口和对应的插头表面将基座和插头匹配。
图6A和图6B示出了具有端头电极540的导线500的一个实施例的远端部,该端头电极540带有基座542和分离插头544。导线也包括导线主体510、510’和一个或多个附加的电极520。在至少一些实施例中,导线主体510通过将导线主体510’模制在电极520之间而形成(并且在至少一些实施例中,模制在导线近端的电极和端子之间,如图1所示)。导线主体510的原料也可以模制在最远端的电极520和端头电极540的基座542之间。在模制工艺中,将要形成导线主体的原料可以流进基座542的内腔541(如图5所示)。任何模制工艺都可以使用,包括但不限于注塑成形。导线主体510、510’可以由能够通过将原料流过其他部件来模制然后固化原料以形成导线主体的任何材料来形成。任何合适的工艺都可以用来固化原料,包括但不限于冷却原料、光固化、热固化、交联或类似方法。合适原料的例子包括聚硅氧烷、聚氨酯、聚醚醚酮和类似物。举个例子,揭露在美国专利公开2011/0078900(以引用方式合并在本申请中)中的用于形成具有分段的电极的导线的方法可以被改进以包含端头电极(例如,通过用端头电极替换图7中的最远端的环形电极)。
当导线主体510成形时,导线主体会延伸进入基座542的内腔,以帮助将端头电极保持在导线500上。当导线500成形后,插头544可以附接于(优选为永久地)基座542,例如通过焊接、钎焊、粘接剂(优选为导电性粘接剂)、压配、压接、螺纹联接基座和插头、或者其任意组合、或其他合适的固定布置方式。优选地,插头544和基座542也通过该固定布置得以彼此导电性地连通。在至少一些实施例中,可以从基座542的远端开口543去除导线主体的一部分以允许插头544与基座的附接。
端头电极导体(未示出)附接、焊接、钎焊或以其它方式与端头电极540电耦联。端头电极导体的电耦联可以在形成导线510之前。像导线中的其他导体一样,端头电极导体沿着导线延伸并且与沿着导线近端布置的其中一个端子电耦联。在一些实施例中,端头电极导体与基座542耦联,例如耦联于内腔541的表面或基座的近端。在一些实施例中,端头电极导体附接于插头544。
端头电极可以包括具有一个或多个特征的柄体,以帮助将端头电极保持在导线的远端。图7示出了一个端头电极740的实施例的截面,其具有电极主体742和柄体746并且柄体上带有形状的保持特征748。电极主体742包括当植入导线时,暴露给组织的至少一部分表面,用于向组织提供刺激。当导线主体成形时,导线主体的原料形成在端头电极的柄体周围,并且有利于将端头电极保持在形成的导线的导线主体内。带有形状的保持特征748阻止端头电极从导线主体抽离。柄体上带有形状的保持特征748通常从柄体746的相邻部分向外延伸,以与导线远端的材料,如导线主体相互作用以阻止端头电极740从导线远端脱出。合适的带有形状的保持特征包括但不限于形成在柄体上一个或多个阶梯形特征、倾斜凸起、凸缘、齿、突起螺纹、或类似物或形成的柄体上的粗糙面。在图7所示的实施例中,带有形状的保持特征在一侧具有斜面760并且在另一侧具有阶梯面762,以阻止端头电极从导线远端脱出。
端头电极导体(未示出)附接、焊接、钎焊或以其它方式与端头电极740电耦联。在一些实施例中,端头电极导体与柄体746耦联。例如,端头电极导体可以耦联于柄体746侧部或柄体的近端。在其他实施例中,端头电极导体可以附接于端头电极的主体部分(如端头电极的非柄体部分)。端头电极导体沿着导线延伸并且与沿着导线的近端布置的其中一个端子电耦联。
图8A示出另一个端头电极840的实施例,其具有电极主体842和柄体846,柄体846具有附接于柄体一端的凸缘850。电极主体842具有当植入导线时,暴露给组织的至少一部分表面,以向组织提供刺激。凸缘可以具有任何合适的形状,包括但不限于盘形、方形、六边形、八角形、三角形、及类似形状。在示出的实施例中,凸缘是齿轮形的盘,其具有形成在盘的侧面的规则的凹槽852,从而使得在盘的边缘周围形成规则的凸起854。端头电极导体(未示出)可以连接于端头电极的任何部分,包括但不限于凸缘850、凸缘的凸起854、或凸缘内的凹槽852。
当导线主体成形时,导线主体的原料形成在柄体846和端头电极840的凸缘850周围,从而帮助将端头电极保持在形成的导线的导体主体内。凸缘850阻止端头电极840从导线主体抽离。形成在凹槽852以及凸缘854周围的导线主体部分可以帮助将端头电极保持在导线上,并且减小端头电极的转动可能性。通常,非圆形凸缘会给端头电极的转动提供一些阻力。
在至少一些实施例中,像图8B示出的那样,在生产过程中会得到半成品电极840’。导线主体形成在半成品电极840’周围,然后导线主体和半成品电极840’经打磨而得到图8A中的端头电极840。打磨工艺也除去多余的导线主体原料,使导线主体留下期望的直径。
图9A示出一个实施例的端头电极940,其具有电极主体942和内腔941的。电极主体942具有当植入导线时,暴露给组织的至少一部分表面,以向组织提供刺激。当导线主体成形时,导线主体的原料流进内腔941,从而帮助将端头电极保持在形成的导线的导体主体内。端头电极940在界定出内腔941的表面上形成突起956。这些突起956帮助将端头电极保持在导体主体上,并且阻止端头电极绕着导线主体转动。在示出的实施例中,突起956的图案形成星形截面,但应意识到的是,也可以采用由进入内腔的突起形成的外部的规则和不规则形状来阻止端头电极绕着导线主体转动。
另外,端头电极940的近端界定出带有突起956’的非圆形开口958,突起956’形成了相对于端头电极内表面邻近部分960的凸缘,该邻近部分界定出内腔941。这些突起956’和产生的类似凸缘的布置,阻止端头电极绕着导线主体转动,并且阻止从导线的远端移走端头电极。
端头电极导体(未示出)可以连接于端头电极的任何部分,包括但不限于端头电极的近端、突起956’、或界定内腔941的表面。在至少一些实施例中,像图9B示出的那样,在生产过程中会得到半成品电极940’。导线主体形成在半成品电极940’周围以及内部。然后导线主体和半成品电极940’经打磨而得到图9A中的端头电极940。打磨工艺也除去多余的导线主体原料,使导线主体留下期望的直径。应理解的是这个实施例可以再改进以包含具有图5-6B示出的带有内腔的基座和分离插头。
图10A示出一个实施例的端头电极1040,其具有电极主体1042、内腔1041、以及从电极主体1042延伸越过内腔1041的入口1064的多个臂1060。电极主体1042具有当植入导线时,暴露给组织的至少一部分表面,以向组织提供刺激。当导线主体成形时,导线主体的原料流进内腔941,从而帮助将端头电极保持在形成的导线的导体主体内。这些臂有助于将端头电极保持在导体主体上,并且阻止端头电极绕着导线主体转动。在示出的实施例中,端头电极1040具有三个臂1060,但应意识到的是,可以使用任何数量的臂,包括但不限于一个、两个、三个、四个、六个或更多个臂。这些臂1060可以任何规则或不规则的布置方式分布在电极主体1042的边缘的周围。
端头电极导体(未示出)可以连接于端头电极的任何部分,包括但不限于端头电极的近端、臂1060、或界定内腔1041的表面。在至少一些实施例中,像图10B示出的那样,在生产过程中会得到半成品电极1040’。导线主体形成在半成品电极1040’周围以及内部。然后导线主体和半成品电极1040’经打磨而得到图10A中的端头电极1040。打磨工艺也除去多余的导线主体原料,使导线主体留下期望的直径。应理解的是这个实施例可以再改进以包含具有图5-6B示出的带有内腔的基座和分离插头。
以上说明、实例和数据提供了对本发明的组合体的制造和使用的描述。因为在不背离本发明的精神和范围的条件下,可以得到很多实施例,本发明的构思也存在于随附的权利要求中。
Claims (20)
1.一种可植入式电刺激导线,包括:
具有远端部、远端头和近端部的导线主体;以及
沿着所述导线主体的所述远端部布置的多个电极,所述多个电极包括布置在所述导线主体的所述远端头的端头电极,所述端头电极具有导电基座以及附接于所述基座的分离导电插头,其中,所述基座的一部分和所述插头暴露于所述导线的外部并且所述基座界定出内腔,并且所述内腔一端通过所述插头封闭,其中所述导线主体的一部分延伸进入所述基座的所述内腔中;
沿着所述导线主体的所述近端部布置的多个端子;以及
多个导体,各个所述导体将至少一个所述电极与至少一个所述端子电耦联。
2.如权利要求1所述的可植入式电刺激导线,其中所述基座与所述插头可导电的连通。
3.如权利要求1所述的可植入式电刺激导线,其中所述多个电极还包括多个分段的电极。
4.如权利要求3所述的可植入式电刺激导线,其中所述多个电极还包括至少一个环形电极。
5.一种可植入式电刺激导线,包括;
具有远端部、远端头和近端部的导线主体;
沿着所述导线主体的所述远端部布置的多个电极,所述多个电极包括布置在所述导线主体的所述远端头的端头电极,所述端头电极具有电极主体、从所述电极主体延伸出来的柄体以及从所述柄体延伸出来的多个带有形状的保持元件,其中所述导线主体的一部分围绕所述柄体和带有形状的保持元件延伸,其中所述带有形状的保持元件有助于将所述端头电极保持在所述导线主体上;
沿着所述导线主体的所述近端部布置的多个端子;以及
多个导体,各个导体将至少一个所述电极与至少一个所述端子电耦联。
6.如权利要求5所述的可植入式电刺激导线,其中所述多个带有形状的保持元件包括至少一个在一侧具有斜边而在相反另一侧具有阶梯形边的至少一个带有形状的保持元件。
7.如权利要求5所述的可植入式电刺激导线,其中所述多个带有形状的保持元件包括至少一个凸起的螺纹。
8.如权利要求5所述的可植入式电刺激导线,其中所述多个带有形状的保持元件包括至少一个阶梯形元件。
9.一种可植入式电刺激导线,包括:
具有远端部、远端头和近端部的导线主体;
沿着该导线主体的所述远端部布置的多个电极,所述多个电极包括布置在所述导线主体的所述远端头的端头电极,所述端头电极具有电极主体、从所述电极主体延伸出来的柄体以及附接于所述柄体并且朝向所述电极主体相反侧的凸缘,其中所述导线主体的一部分围绕所述柄体和凸缘并且在所述柄体和凸缘上延伸,其中所述凸缘有助于将所述端头电极保持在所述导线主体上;
沿着所述导线主体的所述近端部布置的多个端子;以及
多个导体,各个所述导体将至少一个所述电极与至少一个所述端子电耦联。
10.如权利要求9所述的可植入式电刺激导线,其中所述凸缘非圆形并且阻止所述端头电极绕着所述导线主体的所述远端头转动。
11.如权利要求10所述的可植入式电刺激导线,其中所述凸缘具有多个凹槽。
12.如权利要求11所述的可植入式电刺激导线,其中所述多个导体包括在其中一个所述凹槽中与所述端头电极的所述凸缘耦联的端头电极导体。
13.一种可植入式电刺激导线,包括:
具有远端部、远端头和近端部的导线主体;
沿着所述导线主体的所述远端部布置的多个电极,所述多个电极包括布置在所述导线主体的所述远端头的端头电极,所述端头电极具有电极主体,并且所述电极主体界定出内腔和延伸进入所述内腔的多个突起,其中所述导线主体的一部分延伸进入所述电极主体的所述内腔并且其中所述内腔中的多个所述突起有助于将所述端头电极保持在所述导线主体上并且防止所述端头电极绕着所述导线主体的所述远端头转动;
沿着所述导线主体的所述近端部布置的多个端子;以及
多个导体,各个所述导体将至少一个所述电极与至少一个所述端子电耦联。
14.如权利要求13所述的可植入式电刺激导线,其中所述电极主体还界定出通向所述内腔的开口,围绕在所述开口周围形成有多个突起,以使所述开口呈非圆形。
15.如权利要求14所述的可植入式电刺激导线,其中围绕在所述开口周围形成的所述多个突起提供相对于所述内腔的邻近表面的类似凸缘的结构。
16.如权利要求13所述的可植入式电刺激导线,其中所述电极主体还包括基座以及附接于所述基座的分离插头。
17.一种可植入式电刺激导线,包括:
具有远端部、远端头和近端部的导线主体;
沿着该导线主体的所述远端部布置的多个电极,所述多个电极包括布置在所述导线主体的所述远端头的端头电极,所述端头电极具有电极主体以及从所述电极主体延伸出来的多个臂,其中所述电极主体界定出内腔以及通向所述内腔的开口,其中所述多个臂延伸越过通向所述内腔的所述开口,其中所述导线主体的一部分延伸进入所述电极主体的所述内腔并且围绕所述多个臂,所述多个臂有助于将所述端头电极保持在所述导线主体上;
沿着所述导线主体的所述近端部布置的多个端子;以及
多个导体,各个所述导体将至少一个所述电极与至少一个所述端子电耦联。
18.如权利要求17所述的可植入式电刺激导线,其中所述臂以等间隔设置在所述电极主体周围。
19.如权利要求17所述的可植入式电刺激导线,其中所述多个电极还包括多个分段的电极。
20.如权利要求17所述的可植入式电刺激导线,其中所述电极主体还包括基座以及附接于所述基座的分离插头。
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