CN102665818B - 具有径向分段的电极阵列的系统和导线以及制造的方法 - Google Patents

具有径向分段的电极阵列的系统和导线以及制造的方法 Download PDF

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CN102665818B
CN102665818B CN201080040627.XA CN201080040627A CN102665818B CN 102665818 B CN102665818 B CN 102665818B CN 201080040627 A CN201080040627 A CN 201080040627A CN 102665818 B CN102665818 B CN 102665818B
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A·M·皮恩卡
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Abstract

一种制造用于刺激设备的导线的方法，包括：形成以环形的形状的至少一个预电极，所述至少一个预电极包括由至少两个厚壁的部分分隔的至少两个薄壁的部分；靠近导线体的远端布置所述至少一个预电极；将至少一个导体结合到所述至少一个预电极的每个厚壁的部分；以及研磨所述导线体和所述至少一个预电极以去除所述至少一个预电极的所述薄壁的部分，以从所述至少一个预电极的所述厚壁的部分形成分段的电极。

Description

具有径向分段的电极阵列的系统和导线以及制造的方法
对相关申请的交叉引用
本申请要求于2009年7月7日提交的美国专利申请No.12/498,650的优先权；所述专利申请的全部内容通过引用的方式被合并于此处。
技术领域
本发明意在用于包括深脑刺激的脑刺激的方法。此外，本发明意在用于制造具有多个分段的电极的用于脑刺激的导线的方法。
背景技术
深脑刺激可以用于治疗多种病症，包括例如帕金森氏病、肌张力障碍(dystonia)、特发性震颤、慢性疼痛、亨廷顿氏舞蹈病(Huntington’sDisease)、左旋多巴诱发的运动障碍和僵硬(rigidity)、运动徐缓、癫痫症和发作(seizures)、进食失调，以及心境障碍。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所述目标神经元提供所希望的刺激。
一旦插入，电流被沿着所述导线的长度引入以刺激脑中的目标神经元。该刺激由电极提供，所述电极典型地以环形的形式被布置在所述导线上。所述电流沿所述导线的轴在任何给定长度在每个方向上从每个电极相同地发射。由于所述电极的形状，所述电流的径向选择性是最小的。为了要获得的适当的治疗效果，这导致了邻近神经元组织不希望的刺激、不期望的副作用以及增加的持续时间。
研究已表明：当前的制造方法产生不可靠的并且易失效的深脑刺激导线。一项研究表明：关于一些导线产品的导线破损率被报告为6.8-12.4％之间的任何数量，以及破损平均发生在260-390天之间。因此，在许多情况下，在短时间期间内需要修正手术。该修正手术对患者带来身体上、心理上和经济上的重负。
发明内容
在一些实施例中，制造用于刺激设备的导线的方法包括：形成环形的形状中的至少一个预电极(pre-electrode)，所述至少一个预电极包括由至少两个厚壁的部分分隔的至少两个薄壁的部分；将所述至少一个预电极布置在导线体的远端附近，将至少一个导体结合到所述至少一个预电极的每个厚壁的部分；以及研磨所述导线体和所述至少一个预电极以去除所述至少一个预电极的所述薄壁的部分，以从所述至少一个预电极的所述厚壁的部分形成多个分段的电极。
在一些实施例中，制造用于刺激设备的导线的方法包括：将多个电极耦合到临时板；将各个导体结合到所述多个电极的每个；将所述临时板形成为圆柱体，其中所述导体延伸通过所述圆柱体的内腔；用绝缘材料填充所述圆柱体的内腔以形成导线组件；以及去除所述临时板，使所述多个电极暴露。
在一些实施例中，制造用于刺激设备的导线的方法包括：将多个电极布置在模中并且在柔性载体中二次成型(overmolding)；从所述模中去除所述柔性载体和电极；将导体结合到所述多个电极以形成载体；将所述载体实质上成型为圆柱体形状；以及将所述载体结合到导线体。
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，同样的参考标号贯穿各个附图指示同样的部件，除非另外被指定。
为了更好地理解本发明，将参考下面的详细描述，其将结合所述附图而被阅读，其中：
图1是根据本发明，具有多个分段的电极的导线的一部分的一个实施例的示意性立体图；
图2是根据本发明，具有以交错的方向排列的多个分段的电极的导线的一部分的另一实施例的示意性立体图；
图3A是根据本发明，具有多个分段的电极的导线的一部分的第三实施例的示意性立体图；
图3B是根据本发明，具有多个分段的电极的导线的一部分的第四实施例的示意性立体图；
图4是根据本发明，沿导线的长度按照各种电极级(levels)控制的径向电流的示意图；
图5是根据本发明，具有在所述远端暴露的导体电缆的导线的一部分的立体图；
图6是根据本发明，具有由两个厚壁的部分分隔的两个薄壁的部分的预电极(pre-electrode)的示意性横截面视图；
图7是根据本发明，在所述薄壁的部分已被去除以产生两个分段的电极之后图6的所述预电极的示意性横截面视图；
图8是根据本发明，具有由三个厚壁的部分分隔的三个薄壁的部分的预电极的示意性横截面视图；
图9是根据本发明，在所述薄壁的部分已被去除以产生三个分段的电极之后图8的所述预电极的示意性横截面视图；
图10A是根据本发明，被耦合到板的多个电极的示意性立体图；
图10B是根据本发明，在所述板已被形成为圆柱体之后被耦合到板的所述多个电极的示意性立体图；
图10C是根据本发明，在其内腔已被用绝缘材料填充以形成导线组件之后图10B的所述圆柱体的示意性立体图；
图10D是根据本发明，在所述板已被去除之后图10C的所述圆柱体的示意性立体图；
图11A是根据本发明，被置于载体模内的电极阵列的一个实施例的示意性横截面示图；
图11B是根据本发明，已将载体模盖放置在所述载体模上之后图11A的所述载体模和所述电极阵列的示意性横截面示图；
图11C是根据本发明，在载体已围绕所述电极阵列被模塑(mold)之后图11B的所述组件的示意性横截面示图；
图11D是根据本发明，在液体注入成型载体中二次成型的电极的示意性立体图；
图12是根据本发明，导线和探针(stylet)的一个实施例的示意性侧视图。
具体实施方式
本发明意在用于脑刺激(包括深脑刺激)的设备和方法的领域。此外，本发明意在用于制造具有多个分段的电极的用于脑刺激的导线的方法。
用于深脑刺激的导线可以包括刺激电极、记录电极、或者两者的组合。专业人员(practitioner)可以使用所述(一个或多个)记录电极确定所述目标神经元的位置并且随后相应地定位所述(一个或多个)刺激电极，而不去除记录导线以及插入刺激导线。在一些实施例中，相同的电极可以被用于记录和刺激两者。在一些实施例中，可以使用分开的导线，一个具有识别目标神经元的记录电极，并且第二导线具有在目标神经元识别之后代替所述第一个的刺激电极。导线可以包括围绕所述导线的圆周而被间隔的记录电极以更精确地确定所述目标神经元的位置。在至少一些实施例中，所述导线是可旋转的，以便在已使用所述记录电极定位所述神经元之后所述刺激电极可以与所述目标神经元对准。
深脑刺激设备和导线在本领域中被描述。参阅，例如，美国专利申请公开No.2006/0149335A1(“用于脑刺激的设备和方法”(“Devicesand Methods For Brain Stimulation”))、序列号12/237,888的美国专利申请(“用于脑刺激系统的具有非圆形形状的远端的导线以及制造和使用的方法”(“Leads With Non-Circular-Shaped Distal Ends For BrainStimulation Systems and Methods of Making and Using”))、美国专利申请公开2007/0150036A1(“刺激器导线和用于导线制造的方法”(“Stimulator Leads and Methods For Lead Fabrication”))、序列号12/177,823的美国专利申请(“具有转换的导线以及制造和使用的方法”(“Lead With Transition and Methods of Manufacture and Use”))、序列号12/427,935的美国专利申请(“用于刺激导线的电极以及制造和使用的方法”(“Electrodes For Stimulation Leads and Methods ofManufacture and Use”))、以及序列号61/170,037、标题为“用分段电极控制的深脑刺激电流”(“Deep Brain Stimulation Current Steering withSplit Electrodes”)的美国专利申请。这些参考文献中的每个通过引用的方式各自全部地被合并入此处。
图12示出了用于脑刺激的设备1200的一个实施例。所述设备包括导线100、环形电极120、分段的电极130、以及用于辅助将所述导线插入并定位在患者的脑中的探针(stylet)1220。所述探针1220可以由刚性材料制成。合适的材料的例子包括钨、不锈钢或塑料。所述探针1220可以具有手柄1230以辅助插入到所述导线中，以及所述探针和导线的旋转。近端被耦合到，或者可耦合到控制单元。
在操作的一个例子中，接入脑中所期望的位置可以通过以下而被实现：用颅骨钻(通常被称为钻孔器(burr))在患者的头骨或头盖骨中钻洞，以及凝结和切割硬脑膜(dura mater)，或脑覆盖。所述导线100可以在所述探针1220的辅助下被插入到所述头盖骨和脑组织中。所述导线可以使用例如立体定向架(sterotactic frame)和微动马达系统而被引导到脑内的所述目标位置。在一些实施例中，所述微动马达系统可以是完全地或部分地自动的。所述微动马达系统可以被配置为执行一个或多个下列动作(单独的或组合的)：旋转所述导线、插入所述导线，或收回所述导线。在一些实施例中，被耦合到响应于患者或临床医生而被所述目标神经元或单元刺激的肌肉或其他组织的测量设备可以被耦合到所述控制单元或微动马达系统。所述测量设备、用户或临床医生可以指示出由所述目标肌肉或其他组织对所述刺激或(一个或多个)记录电极的响应以进一步识别所述目标神经元以及帮助定位所述(一个或多个)刺激电极。例如，如果所述目标神经元意在肌肉经历震颤(tremors)，则测量设备可以被用于观察所述肌肉并且指示出响应于神经元的刺激的震颤频率或幅度中的变化。可替代地，所述患者或临床医生可以观察所述肌肉并且提供反馈。
用于深脑刺激的导线100可以包括刺激电极、记录电极，或两者。在至少一些实施例中，所述导线是可旋转的，以便在已使用所述记录电极定位所述神经元之后所述刺激电极可以与所述目标神经元对准。
刺激电极可以被布置在所述导线的圆周上以刺激所述目标神经元。刺激电极可以是环形形状的，以便电流从每个电极沿所述导线的轴在任何给定长度在每个方向上相同地发射。为了实现电流控制，可以附加地或可替代地使用分段的电极。尽管下列描述讨论了刺激电极，将被理解的是：也可以在排列记录电极中使用所讨论的刺激电极的所有配置。
图1示出了用于脑刺激的导线100的一个实施例。所述设备包括导线体110、一个或多个可选的环形电极120、以及多个分段的电极130。所述导线体110可以由生物相容的非导电材料(诸如例如聚合材料)形成。合适的聚合材料包括(但不限于)：硅氧烷(silicone)、聚氨酯(polyurethanes)、聚乙烯、聚脲、或聚氨酯-脲。在至少一些情况中，所述导线可以在延长的时间期间与身体组织相接触。在至少一些实施例中，所述导线具有不大于1.5mm的横截面直径以及在至少一些实施例中可以处于1至1.5mm的范围内，所述导线具有至少10cm的长度，并且所述导线的长度可以在25至70cm的范围中。
在至少一些实施例中，刺激电极可以被布置在所述导线体110上。这些刺激电极可以使用金属、合金、导电氧化物，或任何其它合适的导电生物相容材料而被制造。合适的材料的例子包括(但不限于)：铂、铂铱合金、铱、钛、或钨。优选地，所述刺激电极由如下材料制成：所述材料是生物相容的并且在所述预期的使用持续时间在所述操作环境中在预期的操作条件下实质上不腐蚀。
在至少一些实施例中，任一所述电极可以被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一段时间是阴极。在其它实施例中，可以将特定的一个电极或多个电极的身份固定为阳极或阴极。
以环形电极120的形式的刺激电极可以被布置在所述导线体110的任何部分上，通常靠近所述导线的远端。图1示出了具有两个环形电极的导线的一部分。任何数量的环形电极(或者甚至单个环形电极)可以沿所述导线体110的长度而被布置。例如，所述导线体可以具有一个环形电极、两个环形电极、三个环形电极或四个环形电极。在一些实施例中，所述导线将具有五个、六个、七个或八个环形电极。将被理解的是：任何数量的环形电极可以沿所述导线体110的长度而被布置。在一些实施例中，所述环形电极120实质上是圆柱形的并且围绕所述导线体110的整个圆周包裹。在一些实施例中，所述环形电极120的外径实质上等于所述导线体110的外径。环形电极120的宽度可以根据所期望的治疗和所述目标神经元的位置而变化。在一些实施例中，所述环形电极120的宽度小于或等于所述环形电极120的直径。在其它的实施例中，所述环形电极120的宽度大于所述环形电极120的直径。
具有分段的电极的深脑刺激导线提供优良的电流控制，因为深脑刺激中的目标结构不围绕所述远端电极阵列的轴对称。作为替代，目标可以位于经过所述导线的轴而走向(runing)的平面的一侧上。通过使用径向分段的电极阵列(RSEA)，可以沿所述导线的轴但也围绕所述导线的圆周执行电流控制。
所述导线包含多个分段的电极130。任何数量的分段的电极130可以被布置在所述导线体110上。在一些实施例中，所述分段的电极130被分组成分段电极组，每个组在特定的纵向位置处围绕所述导线的圆周而被布置。所述导线可以具有任何数量的分段电极组。在至少一些实施例中，所述导线具有一个、两个、三个、四个、五个、六个、七个、或八个分段电极组。在至少一些实施例中，每个分段电极组包含相同数量的分段电极130。在一些实施例中，每个分段电极组包含三个分段的电极130。在至少一些其它实施例中，每个分段电极组包含两个、四个、五个、六个、七个或八个分段的电极。所述分段的电极130可以在尺寸和形状上变化。在一些实施例中，所述分段的电极130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，每个组的所述分段的电极(或者甚至所有分段的电极)可以在尺寸和形状上一致。
每个分段的电极130的组可以围绕所述导线体110的圆周而被布置以形成围绕所述导线体110的实质上圆柱形的形状。如将参考图7B、8B和9B而被描述的，围绕所述导线体110的圆周的所述分段的电极130的间隔可以变化。在至少一些实施例中，相等的间隔、缝隙或切断(cutouts)被布置在围绕所述导线体110的圆周的每个分段的电极130之间。在其它实施例中，分段的电极之间的间隔、缝隙或切断可以在尺寸或形状上不同。在其它实施例中，分段的电极之间的所述间隔、缝隙或切断对特定的分段电极组或者对所有分段电极组可以是一致的。可以围绕所述导线体110以不规则的或规则的间隔放置所述分段的电极130。
附接到所述环形电极120和分段的电极130或从所述环形电极120和分段的电极130附接的导体(未示出)也通过所述导线体110。这些导体可以通过所述导线的材料或通过由所述导线确定的内腔。所述导体存在于连接器处，用于将所述电极耦合到控制单元(未示出)。在一个实施例中，所述刺激电极对应于线导体，所述线导体延伸出所述导线体110并且随后被修整或被磨削而与所述导线表面齐平。所述导体可以被耦合到控制单元以向所述刺激电极提供刺激信号(经常以脉冲的形式)。
图2是具有多个分段的电极的导线的另一个实施例的示意性侧视图。如在图2中所看到的，所述多个分段的电极130可以相对于彼此以不同的方位被排列。与图1(在图1中，两组分段电极沿所述导线体110的长度而被对准)相反，图2显示了另一个实施例，在其中两组分段电极130被错列(staggered)。在至少一些实施例中，所述分段电极组被错列，以致于没有分段的电极沿所述导线体110的长度被对准。在一些实施例中，所述分段的电极可以被错列以致于所述分段的电极中的至少一个与不同组的另一个分段的电极对准，并且其他分段的电极不被对准。
任何数量的分段的电极130可以被布置在任何数量的组中的导线体110上。图1和2示出了包括两组分段的电极的实施例。这两组分段的电极130可以被布置在不同的配置中。图3A是具有多个分段的电极的导线的第三实施例的示意性立体图。图3A的导线体110具有近端和远端。如将从图3A而被理解的，所述两组分段电极130被布置在所述导线体110的所述远端上，远离于所述两个环形电极120。图3B是导线体110的第四实施例的示意性立体图。在图3B中，所述两组分段电极130被布置为接近于所述两个环形电极120。通过改变所述分段的电极130的位置，可以选择所述目标神经元的不同的覆盖。例如，如果医生预期所述神经元目标将更靠近所述导线体110的远端端头，则图3A的电极排列可能是有用的，而如果医生预期所述神经元目标将更靠近所述导线体110的所述近端，则图3B的电极排列可能是有用的。在至少一些实施例中，所述环形电极120与分段电极130的组相交替。
环形电极120和分段的电极130的任何组合可以被布置在所述导线上。在一些实施例中，所述分段的电极被按组排列。例如，导线可以包括第一环形电极120、两组分段电极、每组由三个分段的电极130形成，以及在所述导线的末端处的最后的环形电极120。该配置可以简单地被称为1-3-3-1配置。用该简化符号指示所述电极可能是有用的。因此，图3A的实施例可以被称为1-1-3-3配置，而图3B的实施例可以被称为3-3-1-1配置。其他八个电极配置包括，例如，2-2-2-2配置，在其中四组分段电极被布置在所述导线上，以及4-4配置，在其中两组分段电极(每组具有四个分段的电极130)被布置在所述导线上。在一些实施例中，所述导线将具有16个电极。用于16-电极导线的可能的配置包括(但不限于)4-4-4-4、8-8、3-3-3-3-3-1(以及该配置的所有重新排列)，以及2-2-2-2-2-2-2-2。
图4是示出了沿导线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常规的导线配置仅能够沿所述导线的长度(所述z-轴)控制电流，所述分段的电极配置能够在x-轴、y-轴以及z-轴上控制电流。因此，可以在环绕所述导线体110的三维空间中在任何方向上控制刺激的形心(centroid)。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可以由被引入到每个电极的阳极电流(认识到刺激主要在所述阴极附近发生，尽管强阳极也可以导致刺激)的百分比规定，如将在下面被更加详细地描述的。在至少一些实施例中，阳极和阴极沿所述分段的电极130的所述配置允许刺激的形心沿所述导线体110被偏移到各种不同的位置。
如可以从图4而被理解的，可以沿所述导线的长度在每个级偏移刺激的形心。沿所述导线的长度在不同的级使用多个分段电极130的组允许三维电流控制。在一些实施例中，共同地偏移所述分段电极130的组(即，刺激的形心沿所述导线的所述长度在每个级是相似的)。在至少一些其他实施例中，每个分段电极130的组被独立地控制。每个分段电极的组可以包含两个、三个、四个、五个、六个、七个、八个或更多的分段的电极。将被理解的是：可以通过在每个级改变分段的电极的数量产生不同的刺激分布(profiles)。例如，当每个分段电极的组仅包括两个分段的电极时，可以在所述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，至少三个分段的电极130被使用以允许真正的360°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配置。在一些实施例中，被耦合到响应于患者或临床医生而被所述目标神经元或单元刺激的所述肌肉或其他组织的测量设备可以被耦合到所述控制单元或微动马达系统。所述测量设备、用户或临床医生可以指示由所述目标肌肉或其他组织对所述刺激或记录电极的响应以进一步识别所述目标神经元并帮助定位所述刺激电极。例如，如果所述目标神经元意在肌肉经历震颤，则测量设备可以被用于观察所述肌肉并指示响应于神经元的刺激的震颤频率或幅度中的变化。可替代地，所述患者或临床医生可以观察所述肌肉并提供反馈。
所述导线的可靠性和耐久性将很大地取决于设计和制造的方法。下面讨论的制造技术提供了用于制造已展示出非常低的导线破损事故的导线的方法。
在一些实施例中，导线的制造开始于所述近端。图5是具有在所述导线体510的所述远端处被暴露的导体540的导线500的一部分的立体图。如上面参考图1所描述的，所述导体540附接到预电极600或从预电极600附接并且也通过所述导线体510。这些导体可以通过所述导线的材料或通过由所述导线确定的内腔。在一些实施例中，所述刺激或记录电极对应于线导体，所述线导体延伸出所述导线体510并且随后被修整或被磨削而与所述导线表面齐平。所述导体540可以进一步被耦合到终端(未示出)。所述终端典型地被布置在所述一个或多个导线体的近端用于连接到被布置在例如控制模块上的连接器中的对应的连接器触点(或连接到其他设备，诸如导线延伸上的连接器触点、操作室电缆、或适配器)。此外，所述控制模块可以向所述刺激电极提供刺激信号(经常以脉冲的形式)。在所述远端处被暴露的所述导线体510和所述导体540的长度可以依最终产品配置所需要的而变化。
在一些实施例中，径向分段的电极阵列的制造开始于预电极，分段的电极从其而被形成。图6是预电极600的示意性横截面视图。在一些实施例中，如在图6中所看到的，所述预电极600具有由两个厚壁的部分620分隔的两个薄壁的部分610。可以通过产生内径630和外径640而形成薄壁的部分610和厚壁的部分620。在一些实施例中，所述外径640是等直径的，但所述内径630不是等直径的。作为替代，所述内径630可以具有不规则的直径，包括例如有键的部分635，在其处所述内径大于剩余的部分或者在其处所述预电极600的部分已被去除或未被形成(unformed)。所述有键的部分635可以是如在图6中所看到的直径的突然变化或直径的更渐进的变化的结果。
所得到的薄壁的部分610和厚壁的部分620可以在尺寸上变化。在一些实施例中，所述薄壁的部分610和厚壁的部分620具有相等的径向尺寸。在至少一些其它实施例中，所述预电极600的圆周的大部分形成所述厚壁的部分620。如在图6中所看到的，在一些实施例中，形成两个厚壁的部分和两个薄壁的部分。在一些实施例中，所述薄壁的部分610具有相等的径向尺寸。在一些实施例中，所述厚壁的部分620具有相等的径向尺寸。将被理解的是：在至少一些其它实施例中，可以形成一个厚壁的部分大于另一个厚壁的部分。
在一些实施例中，图5的所述导线体510包括消蚀的(ablated)部分，用于接收图6的所述预电极600。在一些实施例中，所述导线体的所述消蚀的部分被布置在所述导线体510的所述远端上，特别地被布置在所述预电极600之下的所述导线体510的部分。在一些实施例中，沟槽(slots)、砂砾、喷砂的或粗糙的区域、或涂层(诸如氮化钛)可以被添加到所述预电极600(特别是所述内径)以增加对所述导线体510的粘附力。导体随后可以被耦合到所述预电极600。在一些实施例中，所述导体被焊接到所述预电极600，尽管将被理解的是：可以使用将所述预电极耦合到所述导体的任何合适的方法，诸如激光焊接、电阻焊接、导电环氧(conductive epoxy)，等等。如在图6中所看到的，所述预电极600可以包括开槽的位置650，用于定位所述导体和焊接。在一些实施例中，多个开槽的位置可以被布置在所述预电极600上，以便所述预电极600的每个部分被连接到导体。在至少一些实施例中，如在图6中所看到的，所述开槽的位置650被布置在所述预电极600的相对侧上。
在一些实施例中，隔片(spacers)520沿所述导线体510的长度紧接于每个预电极600而被布置。所述隔片520可以被布置在所述预电极600之间并且可以具有空的中心区域以便所述隔片520可以被穿(thread)到所述导线体510上或者可以被用作所述导线体510的一部分以分隔所述电极。所述导线500也可以包括端隔片(未示出)。所述端隔片被布置在所述导线500的所述远端。所述端隔片可以具有任何形状，但优选地被围绕在所述远端。所述隔片520和所述端隔片可以由任何非导电的生物相容的材料制成，包括例如硅氧烷(silicone)、聚氨酯、以及聚醚醚酮(PEEK)。所述隔片520帮助电隔离所述预电极600。附加地或可替代地，所述预电极可以被布置在邻接的非导电的导线体510的具有通过所述导线体510的开口的部分之上，以允许所述导体540被耦合到所述预电极600。
在一些实施例中，所述预电极600的所述外径可以与所述隔片的外径相同。在一些其他的实施例中，所述预电极600的外径可以可替代地大于所述隔片520的外径，以致于所述预电极600被升高到所述隔片520之上。可替代地，所述隔片520的外径可以大于所述预电极600的外径，以致于所述预电极被凹进。
在所有所述隔片520和预电极600已被装载到所述导线体510上并且如必需时被附接到导体540之后，组件可以经受回流操作。所述回流操作在将所述隔片500和预电极600附接到所述导线体510中是有用的并且改进所述组件和导线的结构完整性以改进可靠性。
所述导线500可以随后被进一步处理以去除所述预电极600的部分。在一些实施例中，所述导线500被无中心地研磨以去除所述外径640的部分(例如以去除所述薄壁的部分610)，尽管将被理解的是：任何合适的方法可以被用于去除这些部分，包括切割、切削(skiving)或激光烧蚀。图7是在所述薄壁的部分610已经被去除之后图6的所述预电极600的示意性横截面视图。如在图7中所看到的，去除所述薄壁的部分的结果是：形成两个分段的电极700。因此，所述薄壁的部分610和厚壁的部分620可以被排列以便在研磨之后形成分段的电极700的任何配置。将被理解的是：也可以排列所述开槽的位置650以致每个分段的电极700在所述研磨处理之后被连接到导体。
图8是具有由三个厚壁的部分820分隔的三个薄壁的部分810的预电极800的示意性横截面视图。所述预电极800具有内径830和外径840。如在图8中所看到的，所述内径具有三个有键的部分835。如在图9中所看到的，当已使用上面所描述的方法去除了所述薄壁的部分时，图8的所述预电极800能够形成三个分段的电极900。在一些实施例中，所述三个分段的电极900具有相同的尺寸。在至少一些其它实施例中，所述有键的部分835将被排列以致在所述研磨处理之后产生不同尺寸的分段的电极900。此外，所述有键的部分可以被排列以致每个分段的电极包括开槽的位置850用于被连接到导体。将被理解的是：可以以该方式形成任何数量的分段的电极。例如，可以使用这些方法产生具有四个、五个、六个、七个、八个、十个、十二个或十六个径向排列的分段的电极的导线。
在至少一些其它实施例中，径向分段的电极阵列开始于板而被形成。图10A是被耦合到板1010的多个电极1000的示意性立体图。可以使用任何合适的方法(诸如电阻焊接、激光焊接、粘合剂等等)将所述多个电极1000耦合到所述板1010。在一些实施例中，所述板1010是铁板，尽管可以使用能够作为支撑结构并通过上面所描述的任一处理(例如，通过选择性的蚀刻处理)去除的任何合适的金属。
所述多个电极1000可以以任何期望的排列被布置在所述板1010上。例如，在一些实施例中，所述多个电极1000在所述板1010上被分成相等间距的行。每行可以包括相同数量或不同数量的电极。在一些实施例中，所述行包括不同数量的电极。所述行也可以相距彼此而被偏移，以致于电极不被纵向地对准。电极之间的所述间距也可以在行内或行之间变化。在至少一些其它实施例中，所述多个电极1000以环形的排列、对角线排列或以任何其他期望的模式被布置在所述板1010上。
随后通过焊接或其他技术将导体(未示出)结合到所述多个电极1000。在一些实施例中，每个单个电极被连接到分离的且不同的导体。在至少一些其它实施例中，多个电极被连接到相同的导体。
在一些实施例中，所述板1010随后被形成为圆柱体。在一些实施例中，为了产生圆柱体，心轴沿所述板1010的中线而被放置并被插入到所述近端子组件的导线体的中央腔中。所述板1010随后可以通过拉模(die)或一系列拉模而被拉制(draw)以形成所期望的圆柱形形状。所述圆柱体可以被形成以便仍然附接到所述多个电极1000的导体通过所述圆柱体的所述中央腔而延伸。图10B是在所述板1010已被形成为圆柱体1020之后被耦合板1010的所述多个电极1000的示意性立体图。
所述新形成的圆柱体1020包括空的中央腔，其中所述导体通过所述腔而延伸。可以用绝缘的或聚合的材料填充所述圆柱体1020的所述中央腔以产生导线体1030。如之前所指示的，合适的聚合材料包括(但不限于)硅氧烷、聚氨酯和聚乙烯。图10C是在其内腔已被用绝缘材料填充以产生导线组件1040之后图10B的所述圆柱体的示意性立体图。在一些实施例中，液体硅氧橡胶被注入到所述圆柱体1020中以形成导线体1030。
在所述圆柱体1020已被用绝缘材料注入以形成导线组件1040之后，所述导线组件1040随后可以经历一系列步骤以固化它。随后从所述导线组件1040去除所述板1010以暴露所述多个电极1000。在一些实施例中，所述导线组件1040被放置在酸洗池(acid bath)内以溶解所述板1010。可替代地，任何合适的技术可以被用于从所述导线组件1040去除所述板1010。图10D是在所述板1010已被去除之后图10C的圆柱体的示意性立体图。所述导线组件1040包括以径向排列的多个电极1000，对应于为将所述多个电极1000焊接到所述板1010而被选择的排列。
将被理解的是：在一些实施例中，使用各种材料形成导线。例如，被注入到所述圆柱体1020中的材料不需要是遍及所述导线的剩余部分所使用的相同的材料。用于导线构成的材料的选择可以取决于多种因素，包括，例如生物相容性、机械性能(例如，柔性、抗拉强度、撕裂强度和延伸率)、生物稳定性、使用性能(handling properties)、制造的容易性、成本、生产时间，等等。因此，可以沿所述导线的不同部分使用不同的材料生产导线。例如，远端可以由一种材料(例如硅氧烷或聚氨酯)制成，以及所述导线的近端可以使用另一种材料(例如聚氨酯或PEEK)而被制成。作为一个例子，因为其是更柔性的材料，硅氧烷可以被选择用于所述导线的远端。由于其是更刚性的并提供了改善插入到控制模块(例如可植入的脉冲发生器)或导线连接器中的更好的刚性，聚氨酯可以被选择用于所述近端。在这些导线中，由不同的材料制成的导线的两个部分在过渡位置耦合在一起。所述过渡位置通常可以是在所述近端和远端之间的沿所述导线的长度的任何合适的位置。甚至当所述导线的所述两个部分由相同的材料制成并随后被结合在一起时过渡位置也可以存在。将被认识到的是：所述过渡位置可以被置于沿所述导线的任何点处并且导线可以包含多于一个的过渡位置。
在一些实施例中，所述过渡位置之上的套筒被用于将所述导线的所述两部分耦合在一起。然而，套筒可以在所述过渡位置处增大所述导线的直径，其可能不是所期望的，特别是由于可能需要更大直径的导引器以在所述过渡位置处容纳所述导线的所述更大的直径。
在至少一些其它实施例中，代替套筒，可以通过修改所述部分的端以形成联接装置而将在所述过渡位置处的所述导线的两个部分耦合。所述导线包括由第一材料制成的第一导线部分(例如被注入到所述圆柱体1020中的部分)和由第二材料制成的第二导线部分。例如，所述第一材料可以是硅氧烷以及所述第二材料可以是聚氨酯，或者反之亦然。将被认识到的是：所述第一导线部分可以是所述导线的远端部分或近端部分并且所述第二导线部分则分别是所述导线的近端部分或远端部分。
图11D是可以使用液体注入模塑法而被模塑到载体中的电极1100的一个实施例的示意性立体图。该过程将参考图11A-11C而被更加详细地描述。如在图11A中所看到的，通过将所述电极1100置于载体模1120中，所述电极1100可以被放置在所期望的阵列排列中。在一些实施例中，所述电极1100被弯曲，如在图11A-D中所看到的。在至少一些其它实施例中，当被放置在所述载体模中时所述电极1100是平面的，并且随后被形成为所期望的形状。用于所述载体模1120的合适的材料包括(但不限于)金属、聚合物(包括塑料)、复合材料，等等。优选地，所述载体模1120由耐久的材料制成，其允许所述载体模1120被重复使用。在一些实施例中，所述载体模1120是曲线的或圆柱形的。所述电极1100可以以任何合适的排列被布置在所述载体模中。所述电极1100可以例如被放置在所述载体模1120中的两列、三列或四列中并且每列可以包含任何数量的电极。因为载体可以围绕心轴而被包覆，被布置在载体模1120内的电极1100的列可以与圆周电极排列相一致，如在图1中所看到的。
所述载体模1120可以包括电极定位特征1125，例如，所述载体模1120中的凹痕(indentations)或凹陷(depressions)，其以所期望的阵列排列而被布置。所述电极定位特征1125帮助以所预定的排列定位所述电极1100。例如，所述电极1100可以被放置在载体模1120中，所述载体模1120在所述模的底部中具有凹痕，其容纳所述电极1100的形状并且在制造所述载体的过程期间将所述电极1100保持在适当的位置。所述电极1100可以是凹的并且所述载体模1120可以具有凹痕，其容纳所述电极1100的所述凹的形状。优选地，所述电极1100的侧表面的至少一部分保持被暴露在所述载体模1120中。
如可以从图11B而被理解的，在所述电极1100被置于所述载体模1120中之后，载体模盖1130可以被放置在所述电极1100和所述载体模1120之上。用于所述载体模盖1130的合适的材料包括(但不限于)金属、聚合物(包括塑料)、复合材料，等等。优选地，所述载体模盖1130由耐久的材料(诸如金属)制成，其允许所述载体模盖11 30被重复使用。
图11C是在载体1140已围绕电极1110的所述阵列而被模塑之后图11B的组件的示意性横截面视图。所述载体1140可以由任何生物相容材料制成，包括例如硅氧烷、聚氨酯、聚醚醚酮(PEEK)、环氧树脂，等等。
可以由任何处理(包括例如模塑(包括注入模塑)、铸造等等)形成所述载体1140。在一些实施例中，所述载体1140由注入模塑形成。在所述载体1140围绕所述电极1100而被模塑之后，导体(未示出)被结合到被置于所述载体1140中的所述电极1100。可选地，在所述导体被耦合到所述电极1100之前，包括所述完成的载体和电极1100的阵列的中间组件可以从所述载体模1120被去除。具有焊接的电缆的所述载体1140随后围绕心轴而被包覆以产生实质上圆柱形的形状并且被放置到二次成型模(overmold)中。所述组件随后被二次成型形成径向分段的电极阵列。
上面的说明、例子和数据提供了本发明的合成物的制造和使用的描述。因为本发明的许多实施例可以被制造而不背离本发明的精神和范围，本发明也存在于以下所附的权利要求中。

Claims (13)

1.一种制造用于刺激设备的导线的方法，包括：
形成以环形的形状的至少一个预电极，所述至少一个预电极包括由至少两个厚壁的部分分隔的至少两个薄壁的部分，其中所述环具有等直径的外径；
靠近导线体的远端布置所述至少一个预电极；
将至少一个导体结合到所述至少一个预电极的每个厚壁的部分；以及
研磨所述导线体和所述至少一个预电极以去除所述至少一个预电极的所述薄壁的部分，以从所述至少一个预电极的所述厚壁的部分形成多个分段的电极。
2.如权利要求1所述的方法，其中靠近所述导线体的所述远端布置所述至少一个预电极包括靠近所述导线体的所述远端布置多个所述预电极，并且进一步包括使用至少一个隔片分隔所述预电极。
3.如权利要求2所述的方法，进一步包括回流所述至少一个隔片。
4.如权利要求1所述的方法，其中所述至少一个预电极的所述薄壁的部分围绕所述至少一个预电极的圆周而被相等地间隔。
5.如权利要求2所述的方法，其中所述至少一个预电极包括三个薄壁的部分。
6.如权利要求1所述的方法，其中形成所述导线体包括：形成具有消蚀的部分的导线体并且将所述至少一个预电极布置在所述导线体的所述消蚀的部分上。
7.如权利要求6所述的方法，其中所述导线体包括近端和远端，并且其中所述消蚀的部分被布置在所述导线体的所述远端上。
8.如权利要求1所述的方法，其中所述至少一个导体是多个导体，并且其中结合至少一个导体包括围绕所述导线体的圆周以规则的间隔单个地焊接所述导体。
9.如权利要求1所述的方法，其中研磨所述导线体包括无中心地研磨所述导线体。
10.如权利要求1所述的方法，其中所述至少一个预电极包括开槽的位置，用于定位所述至少一个导体和焊接。
11.如权利要求1所述的方法，其中形成所述至少一个预电极包括提供所述至少一个预电极，在所述至少一个预电极中所述至少两个厚壁的部分和所述至少两个薄壁的部分具有相同的外径。
12.如权利要求11所述的方法，其中提供所述至少一个预电极包括提供所述至少一个预电极，在所述至少一个预电极中所述至少两个厚壁的部分的内径小于所述至少两个薄壁的部分的内径。
13.如权利要求1所述的方法，其中形成所述至少一个预电极包括以环形形成所述至少一个预电极，其中所述环具有不是等直径的内径。
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