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CN106456966B - 大脑深度刺激导针 - Google Patents

大脑深度刺激导针 Download PDF

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CN106456966B
CN106456966B CN201580019701.2A CN201580019701A CN106456966B CN 106456966 B CN106456966 B CN 106456966B CN 201580019701 A CN201580019701 A CN 201580019701A CN 106456966 B CN106456966 B CN 106456966B
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A·梅尔卡尼兹尼
A·乔丹
A·米查理斯
M·博尔斯
A·德朗萨尔
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Abstract

本发明讨论一种用于大脑深度刺激导针的系统和方法。更特定地,本发明讨论一种刺激导针,所述刺激导针包括微机电系统(MEMS)膜内的一个或多个硅基阻挡层。所述硅基阻挡层可改进装置可靠性和耐用性。所述硅基阻挡层还可改进所述MEMS膜的层之间的粘附性。

Description

大脑深度刺激导针
背景技术
大脑深度刺激(DBS)是一种神经刺激疗法,其涉及刺激人的大脑和身体的电刺激系统。DBS可用于治疗数种神经障碍。通常,DBS涉及电刺激大脑的目标区域。
发明内容
根据本发明的一个方面,一种神经学导针包括一种界定管腔的平坦成形的圆柱形膜。平坦成形的圆柱形膜包括远端、近端以及多个电极。平坦成形的圆柱形膜还可包括从平坦成形的圆柱形膜的远端延伸到管腔中的带状电缆。所述膜可包括多个层,所述层可包括第一聚合物层、至少部分设置在第一聚合物层上方的第一硅基阻挡层和至少部分设置在第一硅基阻挡层上方的第二金属层。其它层可包括至少部分设置在第一金属层或第一硅基阻挡层上方的第二硅基阻挡层。第二硅基阻挡层可界定第一多个穿孔。另一层可为至少部分设置在第二硅基阻挡层层上方的第二聚合物层。第二聚合物层可界定第二多个穿孔。第一多个穿孔与第二多个穿孔基本上对准以界定多个电极中的每一个。所述膜还可包括设置在第一金属层上的第二金属层。
在某些实施方案中,第一金属层可形成多个电极和多条迹线。第一金属层还可形成设置在带状电缆上的多个接触垫。多个接触垫中的每一个通过形成于第一金属层中的迹线与多个电极中的至少一个电耦合。第二金属层可包括金,且第一金属层可包括铂和钛中的一种。
第一和第二硅基阻挡层可包括氮化硅、氧化硅、碳化硅、多晶硅、非晶硅、二氧化钛以及氧化钛(III)中的至少一种。第一和第二硅基阻挡层的厚度可介于约100nm与约2μm之间。
根据本发明的另一方面,一种形成神经学导针的方法可包括形成平坦膜,所述平坦膜包括多个电极和从平坦膜的远端延伸的带状电缆。形成所述膜可包括将第一硅基阻挡层至少部分沉积在第一聚合物层上方,且将第一金属层至少部分沉积在第一硅基阻挡层上方。所述方法还可包括将第二硅基阻挡层至少部分沉积在第一金属层和第一硅基阻挡层上方,且然后将第二聚合物层至少部分沉积在第二硅基阻挡层上方。形成所述膜还可包括将第二金属层沉积在第一金属层上。用于形成导针的方法还可包括加热平坦膜且将经加热平坦膜模制到圆柱体中,所述圆柱体界定管腔。所述方法还可包括将带状电缆延伸到由圆柱体界定的管腔中。
在某些实施方案中,所述方法也包括在第一金属层中形成多个电极和接触垫。多条迹线可将多个接触垫中的每一个与多个电极中的至少一个电耦合。所述方法还可包括将第二金属层沉积在多个接触垫上。可通过在第二硅基阻挡层和第二聚合物层中蚀刻多个穿孔来界定多个电极中的每一个。第一和第二硅基阻挡层可包括氮化硅、氧化硅、碳化硅、多晶硅、非晶硅、二氧化钛以及氧化钛(III)中的至少一种。
根据本发明的另一方面,一种神经学导针可包括一种界定管腔的平坦成形的圆柱形膜。平坦成形的圆柱形膜可包括远端和近端。平坦成形的圆柱形膜还可包括设置在成形圆柱体的外表面上的多个电极以及带状电缆,所述带状电缆从平坦成形的圆柱形膜的远端延伸。带状电缆可朝平坦成形的圆柱形膜的近端延伸到管腔中。平坦成形的圆柱形膜的管腔可填充有封装聚合物,且管主体可与平坦成形的圆柱形膜的近端耦合。
所述导针还可包括设置在带状电缆上的多个接触垫。多个接触垫中的每一个可电耦合到多个电极中的至少一个。导针还可包括设置在多个接触垫中的每一个上的一层金层。金层的厚度可介于约5μm与约50μm之间。导针还可包括周边迹线,所述周边迹线部分包围多个电极中的每一个并且在两个或更多个位置与多个电极中的每一个耦合。
在某些实施方案中,导针可包括与一个定向电极或带状电缆对准的一个或多个定向标记。一个或多个定向标记可不透射线。
在某些实施方案中,多个电极中的至少一个可包括一种网格构形。多个电极中的一个可包括多个圆角。
根据本发明的另一方面,一种制造神经学导针的方法可包含提供平坦膜,其包括远端、近端、多个电极和从平坦膜的远端延伸的带状电缆。
所述方法可包括将平坦膜形成至圆柱体中,所述圆柱体界定管腔。带状电缆可延伸到由圆柱体界定的管腔中,且接着用封装聚合物填充管腔。
所述方法还可包括加热平坦膜。在某些实施方案中,平坦膜的近端与导管耦合。在某些实施方案中,带状电缆可与探针耦合。所述方法还可包括将不透射线染料设置在平坦膜上。
附图说明
本文所述的图是为了说明。在某些实例中,可夸大或放大示出所述实施方案的各个方面以促进对所述实施方案的理解。在附图中,相同字符通常是指全部各个附图中的相同特征、功能上类似和/或结构上类似的元件。附图不一定按比例绘制,反而重点强调说明本传授内容的原理。附图不旨在限制本传授内容的范围。根据以下说明性描述,参考以下附图可更好地理解所述系统和方法,其中:
图1说明一种用于执行神经刺激的示例性系统。
图2说明一种用于神经刺激的示例性刺激导针。
图3A和3B更详细地说明所述远端和示例性刺激导针。
图4说明一种用于制造一种刺激导针的示例性方法的流程图。
图5A-5M说明一种用于制造所述MEMS膜的示例性方法。
图6A-6B说明模制到圆柱体中的所述MEMS膜。
图7A说明耦合到探针的所述已成形MEMS膜。
图7B说明与所述MEMS膜的带状电缆耦合的所述多根导线。
图7C说明将某根导线结合到一块接触垫的工序。
图8A和8B说明所述带状电缆延伸到所述经模制MEMS膜的管腔中。
图9A和9B说明所述刺激导针的近端。
图10A-10C说明所述定向标记沿着所述主体的一部分的放置。
图11A-11I说明包括不同电极设计的多种MEMS膜构形。
图12说明一种具有冗余周边迹线的电极。
图13A和13B说明将一个第二聚合物层涂敷到图12中说明的所述第一隔离层。
图14A和14B说明当在多个迹线边界处施加电压时一个电极中的多个等势表面。
图15A和15B说明多种电极电流密度。
图16A和16B说明具有多条周边迹线的多个圆角电极。
图17说明一个具有多个圆角并且耦合到周边迹线的电极中的一种电流密度分布。
图18说明一种具有成形为网格电极的多个电极的MEMS膜。
图19说明一种成形为网格的电极。
图20说明一种具有多个带的网格电极构形。
图21说明一种网格梯度电极周围的电流密度的一个有限元分析模型。
图22说明沿着图21中模型化的电极周边的弧长的电流密度。
图23A说明一种MEMS膜,其具有垂直于所述刺激导针的长度转动的多个梯度电极。
图23B-23E说明一种梯度网格电极的有限元分析。
图24A和24B说明无带状电缆的一种MEMS膜构形。
图25A-25C说明一种无带状电缆的、耦合到探针并且与一个导针主体耦合的MEMS膜。
图26A-26H说明用于维持所述平坦成形的圆柱形MEMS膜的圆柱形状的多个方法。
图27A-27C说明多个示例性端盖电极。
图28A说明一种耦合到现有刺激导针的MEMS膜。
图28B说明图28A中处于平坦构形的MEMS膜。
图29A-29D说明一种刺激导针的远端,所述刺激导针成形有沿着刺激导针的轴线纵向分布的多个电极。
图29E和29F说明在被设置于外管上之前,处于平坦配置的所述MEMS膜。
图30A和30B说明在患者的脊髓附近植入的所述刺激导针。
图31说明将通电加厚多个电极的工序。
图32A说明一种无铂生长的刺激导针的横截面。
图32B说明一种有铂生长的刺激导针的横截面。
图33A-33N说明一种制造一种具有一层第二经封装金属层的MEMS膜的方法。
图34A-34E说明一种具有两个金属层的MEMS膜的实例。
图35A和35B说明所述刺激导针的一个示例性近端。
图36说明一种将要设置在一个封装管内的示例性MEMS膜。
图37A和37B说明一个铂接触件的两个视图。
图38A和38B说明多个接触件与所述MEMS膜耦合。
图38C说明用多个接触件将多个导线耦合到所述MEMS膜。
图38D说明一种示例性刺激导针,其具有一种设置在一个封装管内的MEMS膜。
具体实施方式
上文介绍且下文更详细讨论的各种概念可以用数种方式中的任何一种来实施,因为所述概念并不限于实施的任何特定方式。具体实施方案和应用的实例主要是为了说明而提供。
图1说明一种用于执行神经刺激的示例性系统50。系统50包括植入到患者102的大脑124中的刺激导针100。刺激导针100通过多条电缆126与刺激器122耦合。刺激器122产生可由刺激导针100传递到患者的大脑124的治疗电刺激。
图2说明一种示例性刺激导针100。刺激导针100包括主体150。主体150还可称为管体、管或导管。主体150包括数个定向标记156。在远端105处,刺激导针100包括一种MEMS膜110。在近端180处,刺激导针100包括多个接触件190。
在刺激导针100的近端180处,刺激导针100包括一个或多个接触件190。这些接触件190可用于在MEMS膜110的多个电极与植入的刺激器122之间建立电连接。例如,每个接触件190可与MEMS膜110的一个或多个电极耦合。然后刺激器122可通过多条电缆126与这些接触件190耦合以刺激组织或记录生理学信号。
刺激导针100的远端105可包括一种MEMS膜110。图3A更详细地说明远端105和示例性MEMS膜110。MEMS膜110可包裹或组装在主体150的远端105周围或成形至耦合到主体150的端部的半刚性圆柱体中。MEMS膜110包括多个电极120。MEMS膜110还可包括带状电缆125,所述带状电缆125缠绕在MEMS膜110的最远端上方并且延伸到由MEMS膜110界定的管腔中。如下文所述,带状电缆125与一条或多条导线160耦合。导线160的长度的一部分缠绕探针153。
MEMS膜110可包括一个或多个电极120。如所说明,MEMS膜110包括12个电极。在某些实施方案中,MEMS膜110可包括约6个与约64个之间的电极、约8个与约32个之间的电极、约8个与约24个之间的电极或约8个与约12个之间的电极。这些电极120可成形为定向或全向电极。当MEMS膜110成形到圆柱体中时,这些全向电极可基本上(例如,至少80%或至少90%)缠绕MEMS膜110的圆周,且这些定向电极可仅仅缠绕平坦成形的圆柱形MEMS膜110的圆周的部分(例如,小于80%)。一个或多个定向电极可电耦合以形成一个全向电极。例如,三个最远电极120可电耦合在一起以在刺激导针100的尖端处形成一个全向电极。在某些实施方案中,MEMS膜110可包括多个全向电极和多个定向电极。例如,这些电极120可成形为两个全向电极和六个定向电极。
多条电迹线可将每个电极120与一条或多条导线160耦合。例如,这些迹线可在MEMS膜110的绝缘层下方延展到带状电缆125,其中这些迹线终止并且与一条或多条导线160耦合。在某些实施方案中,刺激导针100包括用于每个电极120的导线160。在其它实施方案中,刺激导针100包括的导线160少于电极120,因为一条或多条导线160与一个以上电极120电耦合。例如,当MEMS膜110包括两个全向电极和六个定向电极时,刺激导针100可包括八条导线160。这些导线160可沿着主体150的长度朝主体150的近端180延展。这些导线160可横跨主体150的长度到主体150的管腔中。在MEMS膜110的近端180处,这些导线160可与这些接触件190电耦合。
图3B说明刺激导针100的远端105的底侧。在某些实施方案中,MEMS膜110可首先成形为成形至圆柱体中的平坦膜。形成MEMS膜110的这种方法可产生连接焊缝111。
MEMS膜可包括多层。在某些实施方案中,MEMS膜包括五层。所述五层可包括第一聚合物层和至少部分沉积(或者设置)在第一聚合物层上方的第一硅基阻挡层。MEMS膜110还可包括至少部分沉积(或者设置)在第一硅基阻挡层上方的第一金属层。其它层可包括至少部分沉积(或者设置)在第一金属层和第一硅基阻挡层上方的第二硅基阻挡层。第二硅基阻挡层可在第一金属层的多个部分上方界定第一多个穿孔。MEMS膜110的另一层可为至少部分沉积(或者设置)在第二硅基阻挡层上方的第二聚合物层。第二聚合物层也可界定多个穿孔。第二硅基阻挡层和第二聚合物层的多个穿孔基本上对准以界定MEMS膜110的多个电极120和接触垫145中的每一个。
图4说明一种用于制造一种刺激导针的示例性方法400的流程图。方法400可包括形成平坦MEMS膜(步骤401)。然后可将平坦MEMS膜模制到圆柱体中(步骤402)。然后可使MEMS膜的带状电缆延伸到模制圆柱体的管腔中(步骤403)。然后可将经模制MEMS膜与导针主体耦合(步骤404)。
如上文陈述,方法400可开始于形成一种平坦MEMS膜(步骤401)。平坦MEMS膜可为MEMS膜110的平坦版本。平坦MEMS膜一般可称为MEMS膜110。在某些实施方案中,MEMS膜110包括多层。MEMS膜110可包括一个或多个聚合物层、一个或多个硅基阻挡层和一个或多个金属层。例如,MEMS膜110可包括第一聚合物层、第一硅基阻挡层、第一金属层、第二硅基阻挡层、第二聚合物层和第二金属层。这些硅基阻挡层可改进所述层的粘附性、改进金属层的耐擦伤性,并且阻碍所述层之间的离子和水分的流动。离子和水分可横越一个聚合物层并且在一种MEMS装置的金属层中产生电短路。这些硅基阻挡层可防止或减小离子进入这些层中或在这些层之间的流动和水分进入各层中或在各层之间的引入。因此,硅基阻挡层减小这些层之间的离子流和水分可改进MEMS膜110的性能和耐用性。
图5A-5M说明一种用于制造MEMS膜110的示例性方法。更特定地,图5A-5M说明一种用于制造MEMS膜110的示例性薄膜微制造方法的横截面视图。可使用多种技术制造MEMS膜110,且下文描述的方法说明一种用于制造MEMS膜110的可能的方法。制造工序可包括一系列工序步骤,其中沉积或去除(例如,蚀刻)各层以实现最终外观。图5A-图5M中的横截面表明了用于构造MEMS膜110的工序步骤。
在图5A中说明的第一步骤中,提供载体衬底201,诸如由晶体材料(诸如硅)或非晶材料(诸如耐热冲击的硼硅玻璃或其它合适的光滑支撑材料)构成的晶片。将可包括一个或多个子层的第一层202涂敷到晶片201的一个表面。一个子层可为沉积在晶片201上的牺牲层,所述牺牲层在后续电化学蚀刻步骤中去除。在某些实施方案中,牺牲层前面具有称为底层的另一子层,所述另一子层可用于形成蚀刻牺牲层所需要的电化学电解槽。牺牲子层可为铝或诸如AlSi的铝合金(具有较小粒度),而底层可为TiW合金,诸如铬或类似金属。在某些实施方案中,当没有实施牺牲子层时,难以从衬底中去除所得装置且去除所得装置可导致损坏成品装置。
参考图5B,制造工序中的下一个步骤可包括沉积第一聚合物层205。可通过MEMS工序将第一聚合物层205沉积在牺牲层202上,所述MEMS工序诸如(但不限于)(i)旋涂液态聚合物前驱体(诸如聚酰亚胺或硅前驱体);(ii)通过对聚对二甲苯-C进行的化学气相沉积来沉积聚合物;或(iii)将聚合物片材层压到晶片上。在某些实施例中,将聚合物层205加热或烘焙以使其聚合。在某些实施方案中,第一聚合物层205包括溶解在NMP中并且以液态形式自旋到牺牲层202上的聚酰胺酸。将聚合物层205加热成经酰亚胺化的聚酰亚胺。固化形式的聚合物的厚度介于约5μm与约15μm之间。MEMS膜的聚合物层可用作水、水分的障壁,并且隔离MEMS膜的部件。
图5C说明一种硅基阻挡层的沉积。硅基阻挡层可用作辅助后续层的粘附性和耐用性的层。硅基阻挡层还可用作离子阻挡层,并且限制离子到达金属层,这可能危及电性能。硅基阻挡层还可阻止水分到达中间层和金属层,这可能产生短路并且危及电隔离。
在某些实施方案中,通过气相沉积技术(诸如化学气相沉积(CV)和等离子体增强型化学气相沉积(PECVD))或通过溅镀技术(诸如直流(DC)或RF(射频)溅镀)将硅基阻挡层沉积到第一聚合物层205上。硅基阻挡层可包括氮化硅、氧化硅、碳化硅、多晶硅或非晶硅。硅基阻挡层还可包括其它非导电材料,诸如二氧化钛或氧化钛(III)。硅基阻挡层的最终厚度可在从约20nm到约2μm的范围内变动。在某些实施方案中,硅基阻挡层约400nm到约600nm,这可允许硅基阻挡层足够柔韧以便在后续组装技术期间弯折。
现在参考图5D,可将金属层215沉积在硅基阻挡层210的表面上的整个晶片上方。随后,可沉积光阻层217。可通过将光阻层217的多个区域暴露于紫外光并且将这些区域在溶剂中显影来界定光阻层217。因此,将选择性地去除光阻层217的这些暴露区域且将暴露金属层215的多个区域。被光阻层217覆盖的金属层215的多个区域可形成电极、迹线和在金属层内的最终产品的其它部件。
金属层215可包括多种金属,诸如钛、铂、金和神经调节中使用的其它金属。为了改进金属层215的粘附性,可将金属层215涂敷在多层中。例如,可将金属层215涂敷为第一层(诸如钛),然后涂敷为中间层(诸如铂),且最终涂敷为上层(诸如钛)。此三层金属结构可通过使用钛作为粘至硅基阻挡层的粘附层来改进铂层下方和上方的粘附性。钛的粘附层的典型厚度可介于约20nm与约100nm之间或介于约25nm与约75nm之间。铂层的典型厚度可介于约200nm与约7μm之间、介于约400nm与约5μm之间、介于约400nm与约3μm之间、介于约400nm与约1μm之间或介于约400nm与约700nm之间。在某些实施方案中,铂可由另一种具有高度电荷转移能力的材料(诸如氧化铱)取代。
图5E说明蚀刻金属层215之后的工序。如所说明,可局部地去除未被光阻层217覆盖的这些区域中的金属层215。在某些实施方案中,在诸如反应式离子蚀刻器的等离子体蚀刻器中执行金属层的蚀刻。在某些实施方案中,可用氯气蚀刻钛和铂。在完成蚀刻工序之后,可使用溶剂去除光阻层217。
用于沉积并且界定金属层的另一种方法是使用所谓的“剥离”技术。在此方法中,可首先将光阻层沉积到硅基阻挡层210上。可使用光刻法界定光阻层。然后可通过此“剥离”掩模沉积金属层215,且在溶剂中去除剩余光阻。在此方法中,将金属层转移到硅基阻挡层且所述金属层上不需要等离子体蚀刻,且所述金属层可具有一定的工序成本和速度优势。
接着参考图5F,对第二阻挡层220执行沉积。可使用与第一硅基阻挡层210相同的技术来沉积第二阻挡层。第二阻挡层220可具有与第一硅基阻挡层相同或不同的厚度。在某些实施方案中,第二硅基阻挡层是可选的。第二硅基阻挡层220和第一硅基阻挡层210可基本上(例如,至少80%)包围金属层215,从而将其呈现为电隔离。为了分别蚀刻并且界定第一硅基阻挡层210和第二硅基阻挡层220,沉积并且用无尘室技术以光刻法界定第二光阻层227。
如图5G中所说明,蚀刻这两个硅基阻挡层。可使用等离子体蚀刻来蚀刻硅基阻挡层。蚀刻工序的实例将为使用四氟化碳气体(CF4)的反应性离子蚀刻。可使用溶剂溶解去除第二光阻层227。
图5G说明其中界定硅基阻挡层210和220的边缘但是蚀刻未到达金属层215的实例。在某些实施方案中,光刻法可包括金属层215上方的开口,这将导致暴露金属层215。
图5H说明第二聚合物层230的涂敷。第二聚合物层230可具有与第一聚合物层205相同或不同的聚合物,且其可具有相同或不同厚度。
图5I说明第三光阻237的沉积,这可分别形成第一聚酰亚胺层205和第二聚酰亚胺层230的蚀刻周边。在某些实施方案中,在涂敷第三光阻237之前,沉积牺牲层(诸如二氧化硅或氮化硅)以用作聚酰亚胺蚀刻的蚀刻掩模。例如,可沉积厚度为约500nm的二氧化硅层,所述二氧化硅层将用作该工序的蚀刻掩模。
图5J分别说明第一聚酰亚胺层205和第二聚酰亚胺层230的氧等离子体蚀刻的结果。如果涂敷,那么可通过另一次蚀刻去除二氧化硅层。
图5K说明第四光阻层247的沉积。在某些实施方案中,第四光阻层247并未覆盖金属层215的一部分。例如,可维持开口232以产生使金层生长的区域。
图5L说明厚的金层250电镀生长于开口232中。在某些实施方案中,通过将晶片中的这些金属迹线连接到周边金属带来实现金层250,所述周边金属带允许晶片的边缘与金属开口232之间的电连接。当浸入在电镀池中且施加电流时,金将使用金属层215作为电镀生长的晶种层而生长在金属层215上。在某些实施方案中,金层250具有约2μm到约20μm的厚度。可使用溶剂去除第四光阻层247。
图5M说明从晶片201中去除MEMS膜。去除第四光阻层247暴露电极开口233。可通过使用电化学蚀刻去除牺牲层202而从晶片201中去除MEMS膜。去除牺牲层202使得晶片201中没有MEMS膜的底侧。在某些实施方案中,通过将晶片放置在具有高的NaCl浓度的盐水池中来去除牺牲层202。也放置在所述池中的铂电极可用作对照,且可将电压施加于有关于铂电极的铝层。铝和TiW产生的电化学电解槽蚀刻铝——将MEMS膜与晶片201分开。
在某些实施方案中,当完成MEMS晶片且已经去除个别装置时,在将晶片组装为圆柱形状之前可进行进一步工序步骤。
再次参考图4,方法400还可包括模制MEMS膜110。在某些实施方案中,将MEMS膜110模制为界定管腔的圆柱体形状。图6A和6B说明将MEMS膜110模制到圆柱体中。
图6A说明MEMS膜110的平面图。如所说明,MEMS膜110包括十二个电极120。这些电极120可为具有多个圆角的、大致上为矩形的形状。带状电极125从MEMS膜110的远端延伸。带状电缆125可包括将这些电极120电耦合到这些接触垫145的一条或多条迹线。在某些实施方案中,每个接触垫145与一个或多个电极120电耦合。
图6B说明经模制MEMS膜110。在某些实施方案中,加热MEMS膜110且然后将其模制以形成圆柱体。可使用热回流方法将MEMS膜110加热和模制。在某些实施方案中,在模制时将MEMS膜110加热到约300℃。成形圆柱体在被成形为圆柱体后可具有介于约0.5nm与约2mm之间、介于约1nm与约1.5mm之间或介于约1.3nm与约1.5mm之间的内径。可通过将MEMS膜110插入具有最终装置所需的、相同直径的管中形成MEMS膜110的圆柱体形状。可将管内的MEMS膜110加热到导致聚合物绝缘体稍微回流且呈现管的新形式的温度。
带状电缆125的端部可耦合到探针153。图7A说明耦合到探针153的成形MEMS膜110。将MEMS膜110耦合到探针153可使带状电缆125的远端呈现刚性并且可简化后续组装步骤。例如,将探针153与带状电缆125耦合可便于将这些导线160耦合到这些接触垫145。探针153可包括金属材料(例如不锈钢)、陶瓷材料或聚合物材料。在某些实施方案中,探针153可不透射线,使得外科医生在植入过程期间可用x射线或CT扫描将刺激导针100视觉化,以控制刺激导针100的最终放置。探针153还可用于确定刺激导针的旋转,因为探针153沿着其纵轴部分平坦。
图7B说明与MEMS膜110的带状电缆125耦合的这些导线160。在某些实施方案中,这些导线160盘绕探针153。这些导线160可通过激光焊接、超声结合、卷边、热压缩结合或导线结合与这些接触垫145耦合。在某些实施方案中,将这些导线160局部平坦化以增加与这些接触垫145接触的导线160的表面面积。
图7C说明将导线160导线结合到一个接触垫145的工序。如所说明,导线160穿过接触垫145。可消除导线160的端部处的绝缘,因此导线160内的导体可与接触垫145接触。一个导线结合物147将接触垫145连接到导线160。可通过使用热量、压力、超声能量或其组合在导线结合物147、接触垫145和导线160之间形成焊接。
再次参考图4,方法400还可包括将带状电缆延伸到通过模制MEMS膜形成的管腔中(步骤403)。可将带状电缆125折叠,使得带状电缆125的一部分和探针153的一部分设置在由成形MEMS膜110界定的管腔内。在某些实施方案中,可用诸如环氧树脂的封装聚合物回填由MEMS膜110界定的管腔。在用聚合物回填之前可将MEMS膜110放置在圆柱形模具中。回填MEMS膜110可用于将这些导线160固定在适当位置并且将连接件电封装在管腔内。在某些实施方案中,回填工序还可用于将圆柱形外观形成至刺激导针100的远端。
图8A说明将带状电缆延伸到经模制MEMS膜110的管腔中。可将带状电缆125折叠,使得带状电缆125的一部分和探针153的一部分设置在由经模制MEMS膜110界定的管腔内。带状电缆125和探针153的部分可通过暂时沿着焊缝111打开圆柱体而延伸到管腔中。
图8B说明回填工序之后的MEMS膜110。可用聚合物材料回填或-共模制由MEMS膜110界定的管腔。回填工序可将MEMS膜110密封在适当位置并且电隔离在带状电缆125的端部处连接到这些接触垫145的这些导线160。回填聚合物可填充管腔的内部并且还可产生远端半球形尖端151。在某些实施方案中,添加内部圆柱体161,其靠近导线160上方的回填材料。内部圆柱体161可减小当从柔韧导线160转变为经回填MEMS膜110的相对刚性聚合物填充时最终装置的顺应性(例如柔韧性)的突然变化。
再次参考图4,其中,方法400还可包括将经模制膜耦合到导针主体(步骤404)。主体150可通过胶水或粘附剂与经模制MEMS膜110耦合。在某些实施方案中,可将主体150模制在MEMS膜110的近端的一部分的上方。除了将主体150固定到MEMS膜110之外,将主体150模制在MEMS膜110上方可帮助MEMS膜110维持圆柱形状。主体150的近端可包括所述一个或多个接触件190。
图9A和9B说明刺激导针100的近端180。刺激导针100的近端180可包括多个接触件190。如所说明,刺激导针100的近端180包括八个接触件190。每个接触件190均与至少一条导线160电耦合。在某些实施方案中,刺激导针100的近端180与刺激导针100的其它部分相比更硬。提高近端180的硬度可辅助将近端180与刺激器或延伸电缆耦合。刺激导针100还可包括图9B中说明的管腔182。在某些实施方案中,管腔182延展刺激导针100的长度。
图10A-10C说明定向标记156沿着主体150的一部分的放置。定向标记156可使得神经外科医生在将刺激导针100植入患者体内时能够确定刺激导针100的放置和旋转。例如,定向标记156可使得神经外科医生能够确定刺激导针100的轴向定向(例如旋转)并且确定这些定向电极面朝何种解剖结构。在某些实施方案中,定向标记156可为延伸刺激导针100的长度的实线。定向标记156还可包括虚线或一系列圆点。
定向标记156可与具体特征(或刺激导针100的界标)对准。例如,定向标记156可与一个定向电极120对准,如图10A中所说明。在另一实例中,定向标记156可与MEMS膜110的焊缝111对准,如图10B中所说明。定向标记156还可与两个电极120之间的间隙或与带状电缆125对准(例如,如图10C中所说明)。
定向标记156可为压印墨线或在挤压主体150期间可涂敷到刺激导针100作为,例如染料。定向标记156可改变主体150的反射率并且可实施为不透射线油墨或染料以提供术中和术后成像。在某些实施方案中,激光标记可用于局部地改变主体150的纹路、颜色或反射率以用作定向标记156。
MEMS膜110可包括多个刺激电极和多个记录电极的组合。在某些实施方案中,一个电极120可为记录电极或刺激电极,或这二者。例如,为了用作刺激电极,电极120可与刺激器耦合,且为了用作记录电极,电极120可与模数转换器和放大器耦合。在某些实施方案中,这些记录电极和这些刺激电极可不同地形或配置。例如,记录电极与刺激电极相比可具有更小尺寸。
神经外科医生在刺激导针100的植入期间可在一个或多个电极中进行记录。例如,神经外科医生可以记录神经活动的β带(约15到30Hz)的神经生理学活动,因为β带与运动行为紧密相关。
图11A-11I说明包括不同电极设计的平坦MEMS膜110构形。每种MEMS膜110均包括三列电极120并且因此可记录三个方向(标记为0度、120度和240度)上的电活动。MEMS膜110还可包括三列以上电极120,以使得刺激导针100能够在三个以上方向上记录和刺激。每种不同的MEMS膜110的每个电极120可彼此电隔离以形成多个定向电极,或者一个或多个电极120可彼此电耦合以形成多个全向电极。作为参考,当将图11A-11I中所说明的MEMS膜被模制成圆柱体时,MEMS膜中朝向页面底部的端部耦合到主体150。
图11A说明被成形为具有多个长形电极120和多个圆形电极120二者的MEMS膜110。长形电极可包括半圆端。在某些实施方案中,圆形电极可被成形以用作多个记录电极且长形电极可被成形以用于刺激神经组织。记录电极可记录在刺激导针100因手术进入大脑期间的神经活动。通过将记录电极靠近刺激电极,由记录电极在刺激电极的刺激之后捕捉的电活动在临床上可与刺激导针100的放置有关。在某些实施方案中,从任何或全部记录电极中捕捉的记录数据在临床上可与确定应使用哪个刺激电极来刺激具体目标有关。图11B说明类似实施方案,但是电极包括圆角而非半圆端。
图11C说明其中电极120具有相同大小的平坦MEMS膜的实施方案。在某些实施方案中,最近一行电极和最远几行电极各自电互连,且因此每一行均可用作圆周电极。
图11D说明具有被成形为圆形电极的电极120的平坦MEMS膜。被成形为圆形电极的电极120可改进对电极的边缘周围的电荷密度的考虑。图11E说明具有多个电极120的平坦MEMS膜,这些电级被成形为不同尺寸的圆形电极。较大的圆形电极可用于刺激且较小的圆形电极可用于记录。图11F说明具有被成形为其中多行紧密放置在一起的圆形电极的电极120的平坦MEMS膜。
图11G说明具有其中电极120被成形为长形电极和圆形电极的电极排列的平坦MEMS膜。长形电极可被成形为记录电极并且沿着每一行与圆形电极交错,从而可被成形为刺激电极。图11H说明具有其中每个电极120包括内部部分294和外部部分292的电极排列的平坦MEMS膜。在某些实施方案中,内部部分是刺激电极且外部部分292是记录电极。图11I说明其中每个电极包括四个带299的平坦MEMS膜。在某些实施方案中,两个或更多个带299电耦合在一起。
一个或多个电极120可包括改进刺激导针100的可靠性的冗余迹线。这些电极120可经由嵌入在MEMS膜110中的金属迹线连接到带状电缆125的端部上的这些接触垫145。迹线可具有围绕某个电极120的周边的若干冗余度以减小所述电极120将与耦合有所述电极120的一个接触垫145断开的概率。例如,图12中用MEMS电极膜300的简化实施例演示了此设计。
图12说明具有多个带有冗余周边迹线的电极的MEMS膜。如所说明,将金属层沉积到聚合物层305上。金属层可包括这些接触垫145、这些迹线315、这些周边迹线314和这些电极120。每条周边迹线314可围绕相关电极120的周边延伸。所述周边迹线314可与一个电极120在多个连接点316处耦合。每个电极120可包括四个连接点316。在某些实施方案中,每个电极120在电极120的每个边缘处包括一个或多个连接点316。例如,图12中说明的多个电极120是具有四个边缘且每个边缘具有一个连接点316的正方形。在某些实施方案中,这些接触垫145还可被周边迹线314包围。
图13A和13B说明将第二聚合物325(或隔离层)涂敷到图12中说明的第一隔离层305。第二聚合物层325可包括与这些电极120和这些接触垫145对准的多个穿孔310。可沉积在金属层上方的所述硅基阻挡层也可包括与第二聚合物层的穿孔310对准的多个穿孔。第二聚合物325可结合到第一聚合物层305的表面和金属导电层。可用光刻法界定第二聚合物325。图13B中演示了所得层堆叠,其中,通过这些穿孔310,这些电极120和对应的接触垫145透明,但是这些迹线315和周边迹线314隐藏不可见并且与外界环境电隔离。
图14A和14B说明当在多个迹线边界处施加电压时一个电极中的等势表面。在图14A中,电极仅耦合到单条迹线315并且不包括周边迹线314。在某些实施方案中,所述迹线315与所述电极120之间的结合处是其中所施加电压最高的区域。图14A说明当在迹线315处施加电压时电极120中的等势表面332。电势集中在一个拐角处,其靠近迹线315与电极120之间的结合处。在某些实施方案中,集中的电势可促成解决结合处的装置可靠性问题。图14B说明具有周边迹线314的电极120。周边迹线314具有连到电极120的四个连接点,更好地将电势337分布在整个电极120中。电势的分布可提高电极健康并且在一个连接点断裂时提供冗余度。
电极120可包括多个圆形电极拐角以降低每个电极120上的电流密度的集中点。图15A说明矩形电极120,其电压施加于所述电极。在此实例中,电极的拐角处可产生高电流密度。图15B说明具有圆形端或半圆端的电极120,从而可减小相对于矩形拐角的电流密度。减小电流密度可保护电极免于降级。
图16A和16B说明具有多条周边迹线的多个示例性圆角电极。图16A说明具有四个圆角电极120的MEMS膜。电极120可通过迹线315连接到接触垫145。迹线315与周边迹线314耦合,这使得电压分布在多个接触点316处是相等的,且由此将电压更均匀地分布在整个电极表面中。如所说明,周边迹线314并未包住电极120的周边;然而,在某些实施方案中,周边迹线314可完全包住电极120的周边。图16B说明其中第二聚合物层375在适当位置从而封装周边迹线314和迹线315的MEMS膜。
图17说明一个具有多个圆角并且耦合到一条周边迹线的电极中的电流密度分布。一个圆角电极120被周边迹线314完全包围。周边迹线316到电极120具有两个连接件。当将电势施加于所述迹线315时,这些等势区域382围绕周边迹线316分布并且在两个连接点处进入电极120。通过将电势施加于电极120的多个点,电势更均匀地分布在整个电极120中。
这些电极120可包括网格。图18说明具有被成形为网格电极的多个电极120的MEMS膜110。网格电极构形可用于将电流密度集中在电极表面的某些区域中-例如中心。图19说明一个被成形为网格电极的电极120。网格电极120可包括多个同心带。在某些实施方案中,每个带具有相同厚度,且在其它实施方案中,如图19中所说明,每个带均可朝电极中心变窄。每个带朝网格电极120的中心变窄,可朝电极120的中心提高电流密度,并且由此限制电流从电极周边扩散。在某些实施方案中,网格电极具有将受电流影响的组织的体积集中到电极中心的效果,因此增强定向刺激在患者体内的效果。
图20说明具有多个带的网状电极构形。MEMS膜420包括多个网格梯度电极427。每个网格梯度电极427均包括多个电极带423。在某些实施方案中,这些带朝网格梯度电极427的中心变窄。这些带变窄可将电流密度朝电极427的中心集中。图21说明网格梯度电极周围的电流密度425的有限元分析模型,所述模型示出了电流密度朝网格梯度电极423的中心最高。图22说明沿着图21中模型化的电极的周边的弧长的电流密度425。图21和22中所说明的数值分析示出了可使用网格电极使电流密度峰值远离电极周边移位并且移位到电极的中心。
图23A说明一种MEMS膜,具有多个垂直于刺激导针100的长度转动的梯度电极。梯度网格电极427在MEMS膜上实施以沿着MEMS膜纵向地集中电流的量。图6A到6B23B和23C说明梯度网格电极427的表面与导电介质接触时所述表面处的电势的有限元分析模型。数值分析表明了可使用梯度网格使电流密度峰值426远离电极周边且朝电极427的中心移位。图23D说明沿着电极长度的电流密度426的峰值,并且表明了由于适当的梯度网格划分,可驱使高电流密度的峰值朝电极中心远离周边。图23E说明非网格电极的电流密度2301之间的差值。非网格电极的电流密度2301在其周边处包括多个电流密度峰值。网格电极的电流密度2302包括朝电极中心的多个峰值。
在某些实施方案中,梯度网格构形通过避免负效应并且将刺激信号集中在预期目标区域上来增强受测人体内的电刺激的效力。
图24A和24B说明无带状电缆的MEMS膜110配置。图24A说明处于平坦构形中的无带状电缆的MEMS膜110。接触垫区域525从MEMS膜110延伸。接触垫区域525多个接触垫145。所述电极120通过多个迹线与一个或多个接触垫145电耦合。MEMS膜110还可包括多个通孔527(或MEMS膜110中的孔)。通孔527可通过使得所述封装环氧树脂能够围绕接触垫区域525流动且完整地封装接触垫区域525来辅助组装。通孔527还可改进MEMS膜110与接触垫区域525的结合处的弯折。
图24B说明热重整成圆柱形状之后的MEMS膜110。经模制MEMS膜110界定内部管腔530。接触垫区域525折叠到管腔530中。在某些实施方案中,用封装环氧树脂回填管腔530。
图25A说明无带状电缆的耦合到探针并且与主体150耦合的MEMS膜。如所说明,去除无带状电缆的MEMS膜的顶部以观察由经模制MEMS膜界定的管腔的内部。接触垫区域525与探针153耦合且多个导线160与接触垫145耦合。图25B说明的实施例与图25A中所说明的相同,但是从不同角度说明的。在这些和其它实例中,去除MEMS膜的多段以说明内部结构。
图25C说明处于已组装和包覆状态中的无带状电缆的MEMS膜110。在将这些导线160焊接在适当位置之后,用聚合物或环氧树脂溶液回填MEMS膜110以增强圆柱形状。聚合物还封装并且隔离连到这些接触垫145的导线160连接件。在某些实施方案中,无带状电缆的MEMS膜与具有带状电缆的MEMS膜相比更可靠。接触垫区域525还可在电极位置120之间提供更大间距以使迹线通向接触垫145。
图26A-26H说明用于维持平坦成形的圆柱形MEMS膜的圆柱形状的多个方法。图26A说明可用钩和夹具维持圆柱形状的MEMS膜110。MEMS膜110可包括两个钩607和两个缺口605或其它数量的钩或缺口。图26B说明其中钩607与缺口605耦合的平坦成形的圆柱形MEMS膜110。当MEMS膜110被成形为圆柱体时,MEMS膜110的相对侧上的钩607和缺口605彼此对准。每个钩607可滑入其匹配缺口605的凹口中。在某些实施方案中,也可将平坦成形的圆柱形MEMS膜110的焊缝胶合在适当位置。
图26C说明使用多个固定孔625以维持平坦成形的圆柱形MEMS膜110的圆柱形状。MEMS膜110在MEMS膜110的每个拐角处均包括一个孔625。在某些实施方案中,MEMS膜110还可沿着MEMS膜110的每个长边缘包括多个附加孔625。如图26D中所说明,当MEMS膜110被成形为圆柱体时,两个孔625彼此对准。导线627可延展穿过每个孔625以固定焊缝并且维持平坦成形的圆柱形MEMS膜110的圆柱形状。导线627可为金属或聚合物导线、卡钉或夹具。
图26E说明平坦成形的圆柱形MEMS膜110的远端。MEMS膜110可包括下垂物634,所述下垂物634位于MEMS膜110的相对边缘632下方。下垂物634可提供用于涂敷粘附剂的平台。可将下垂物634和相对边缘632机械地压在一起以在平坦成形的圆柱形MEMS膜110的焊缝处形成密封。在某些实施方案中,下垂物634可延伸到由平坦成形的圆柱形MEMS膜110界定的管腔中。在这些实施方案中,当用环氧树脂回填管腔时,可将下垂物634截留在环氧树脂内,从而防止将平坦成形的圆柱形MEMS膜110拆散。在某些实施方案中,如图26F中说明,下垂物实施例可包括多个孔625。如在上文说明的实例中,可通过穿过每个孔625的导线627将MEMS膜110的两个边缘绑在一起。
图26G和26H说明一种用于维持平坦成形的圆柱形MEMS膜110的圆柱形状的包覆方法。一旦成形为圆柱形状,一个端盖可在MEMS膜110的远端上方形成轴环655。主体150可在MEMS膜110的近端上方形成轴环655。如图26H所说明,端盖的轴环655(和主体150的轴环655)与MEMS膜110重叠预定距离657。在某些实例中,轴环655可在焊缝111上方纵向地延伸以将由MEMS膜110的边缘形成的间隙沿着圆柱体形状的长度封闭。
所述刺激导针100可在刺激导针100的端盖上包括远端记录部位。图27A说明具有多个端盖电极的示例性MEMS膜110。所述刺激导针100可包括与刺激导针100的端盖725耦合的多个端盖电极715。如图27A中说明,刺激导针100包括沿着四个端部标签710设置的五个端盖电极715。端盖电极715可用于识别将刺激导针100植入患者大脑期间的神经活动。端部标签710可与端盖耦合以确保端盖电极715在植入期间保持在适当位置。
图27B说明被成形为包括远端记录部位的刺激导针100的端视图。如上所述,刺激导针100可包括设置在端盖725的表面上的五个端盖电极715。刺激导针100可包括中心端盖电极715,且然后包括定位成稍微紧靠中心端盖电极715的多个端盖电极715。在某些实施方案中,定位成稍微紧靠中心端盖电极715的一个端盖电极715指向前面、后面、侧面和内侧方向中的每一个。
图27C说明具有多个端盖电极715的平坦MEMS膜110。四个端部标签710从MEMS膜110的远端延伸。在某些实施方案中,MEMS膜110可包括四个以上端部标签710。例如,MEMS膜110可包括5个与12个之间的端部标签710。每个端部标签710上均设置有至少一个端盖电极715。在某些实施方案中,一个端部标签710较长并且包括附加一个端盖电极715。较长端部标签710可延伸到端盖725的顶点,且较长端部标签710的端部处的端盖电极715在涂敷于端盖725时是中心端盖电极715。
MEMS膜可与现有刺激导针耦合。图28A说明一种耦合到现有刺激导针(诸如Medtronic 3389DBS Lead(Medtronic Inc.,MN))的MEMS膜730。MEMS膜730可位于多个现有环形电极755之间或周围。MEMS膜730可将多个附加电极120和多个端盖电极715添加到现有刺激导针。MEMS膜730的附加可提高现有刺激导针的定向记录或刺激的能力。图28B说明处于平坦构形的MEMS膜730。MEMS膜730包括沿着单臂742设置的四个电极120以及一个端盖电极715。在某些实施方案中,MEMS膜730包括跨一个或多个臂742设置的多行电极120。每个臂742可被配置为配合在每个环形电极755之间。
所述刺激导针可具有沿着刺激导针的轴纵向分布的电极。电极可沿着刺激导针的轴纵向分布以实现电极位置之间的屈曲。例如,在脊髓或骨盆底刺激中可使用柔韧的刺激导针。
图29A说明一种刺激导针760的远端,所述刺激导针760配有沿着刺激导针760的轴纵向分布的多个电极。刺激导针760包括一种MEMS膜770,其可实现电极部位之间的屈曲。MEMS膜770连接到这些导线160,所述导线160在设置有MEMS膜770的所述外管765内。
图29B-29D说明刺激导针760的远端的放大视图。MEMS膜770包括缠绕外管765的圆周的多个电极120。每个电极120通过嵌入在相应的带状电缆125中的多条迹线与一个接触垫145耦合。导线160通过焊接、结合或胶合而连接并且结合到每个接触垫145以将每个电极120电耦合到MEMS膜770的近端。以相同方式在MEMS膜770上组装全部后续电极部位775。图29C和图29D提供神经刺激导针760的相同远端的附加平坦视角。
图29E说明在设置于外管765上之前处于平坦构形的MEMS膜770。MEMS膜770包括设置在多个突片780上的多个电极120。通过带状电缆125将突片780连接在一起,所述带状电缆125包括用于至少一个电极120的所述接触垫145。图29F说明MEMS膜770的另一种构形,其中一个以上电极120设置在每个突片780上。在每条带状电缆125上增加接触垫145的数量以匹配设置在每个突片780上的电极120的数量。在某些实施方案中,可在每个突片780上设置2个与12个之间的电极。
图30A和30B说明在患者的脊柱附近植入的刺激导针760。刺激导针760的柔韧性质使得刺激导针760能够插入在待定位于靠近脊髓817的脊骨815之间。
在某些实施方案中,将这些铂电极加厚。可将电极的铂电镀加厚超过其原本厚度。例如,一种方法是将刺激导针的远端插入电镀池中并且将电流施加于这些接触件以激活铂层的生长。图31说明将电极电镀加厚的工序。将一刺激导针100插入池842中且使用电镀源845施加电流。在某些实施方案中,在经模制刺激导针100上生长加厚层(但并非在加厚层的载体晶片上生长平坦刺激导针100)的一个优势是:加厚层在随后模制为圆柱形状时不一定受到应力。在这些实施方案中,多种等离子体沉积方法可用于将附加的铂或诸如氧化铱的其它材料沉积到大于电极的原本厚度的厚度。
图32A说明一种无铂生长的刺激导针100的横截面,且图32B说明一种具有铂生长的刺激导针100的横截面。图32A和32B说明每根刺激导针100包括第一聚酰亚胺层870、第一硅基阻挡层872、第一金属层878、第二硅基阻挡层874和第二聚酰亚胺层876。如图32B中说明,将经电镀生长的铂层880沉积在其中暴露金属晶种层878的多个区域上。铂层880的生长可靠近第二聚酰亚胺层876的上表面(例如,相距几微米),或铂层880可提供齐平到第二聚酰亚胺层876的表面的铂厚度。
在某些实施方案中,将这些迹线或所述刺激导针100的其它金属部件设置在包括这些电极120的所述金属层下方的第二金属层中。第二金属层中的多条迹线使得其能够在除这些接触垫或电极的边缘之外的位置处连接到接触垫和电极。这可实现这些接触垫和多个电极的更均匀电流密度。另外,连到电极的每个连接件均可与相同电势接触——改进电流密度的均匀性。图33A-33N说明所述制造一种具有第二封装金属层的MEMS膜的方法。
图33A说明其中提供载体衬底901的工序的第一步骤。可将包括至少两个子层的第一层902涂敷到衬底901的表面。第一层902的一个子层可为牺牲层,所述牺牲层随后在后续电化学蚀刻步骤中去除,以将成品MEMS膜与载体衬底901分离。牺牲子层前面可具有称为底层的另一子层,所述另一子层可用于形成所述电化学电解槽以蚀刻所述牺牲层。
参考图33B,制造工序中的下一个步骤可包括在牺牲层902上沉积第一聚合物层905。第一聚合物层的厚度可介于约2μm与约15μm之间。
参考图33C,可沉积硅基阻挡层910。硅基阻挡层910的厚度可介于约500nm与约5μm之间,这可使得硅基阻挡层910足够柔韧以在后续组装技术期间弯折。
图33D说明沉积在硅基阻挡层910的表面上的整个晶片上方的第一金属层915。可使用光刻法技术构成第一金属层915内的多个结构(诸如迹线和接触件)。通常可通过沉积若干金属层(诸如沉积钛、铂且再次沉积钛)形成可改进粘附性的三层来结合第一金属层915。可分别沉积具有50nm、300nm和50nm的厚度的三层。
参考图33E,可沉积第二硅基阻挡层920。第二硅基阻挡层920可使用与第一硅基阻挡层910相同的技术来沉积并且通常可具有类似厚度。在某些实施方案中,第二硅基阻挡层920稍微厚于第一硅基阻挡层910。如图33E中说明,第二硅基阻挡层920和第一硅基阻挡层910完全包围金属层915,从而使其呈现电隔离。
图33F说明可对第二硅基阻挡层920执行局部蚀刻以产生暴露第一金属层915的一个硅基阻挡层通孔(穿孔)917。
参考图33G,将第二金属层925沉积在第二硅基阻挡层的表面上。第二金属层925包括类似于第一金属层915的金属,并且可具有相同或类似于第一金属层915的厚度。第二金属层925通过硅基阻挡层通孔917与第一金属层915电接触。
图33H说明第三硅基阻挡层927的沉积。第三硅基阻挡层927可以用类似于第一障壁金属层910的方法沉积,并且可具有相同或类似于第一障壁金属层910的厚度。
图33H说明这些层的蚀刻。可使用等离子体蚀刻来蚀刻这些硅基阻挡层。蚀刻工序的实例包括使用四氟化碳气体(CF4)的反应性离子蚀刻。可使用光阻层来界定蚀刻哪些区域。可在第三硅基阻挡层927中产生多个开口以暴露第二或第一金属层。
图33I说明沉积在衬底上的第二聚合物层930。第二聚合物层930可为相同或不同于第一聚合物层905的聚合物,且第二聚合物层930可具有相同或不同厚度。在某些实施方案中,第二聚合物层930是聚酰亚胺并且具有介于2μm与15μm之间的厚度。
图33J分别说明第一聚酰亚胺层905和第二聚酰亚胺层930的氧等离子体蚀刻的结果。蚀刻工序在第二聚酰亚胺层930中产生多个开口932以暴露第三硅基阻挡层927。
图33K说明蚀刻第三硅基阻挡层925以产生多个金属开口933来暴露第二金属层925。在某些实施方案中,还可将这些开口933向下延伸到第一金属层915的多个区域。这些开口933可界定与神经组织接触或用于界定多个接触垫145的这些电极120的区域。
图33L说明将光阻层935沉积在衬底上方。光阻层935可维持所述暴露的金属开口933。光阻层935中的所述开口937可产生使金层生长的区域。
图33M说明在开口937中电镀生长厚的金层940。可通过将晶片中的全部金属迹线连接到周边金属带来生长金层940,所述金属带允许晶片的边缘与金属开口937之间的电连接。在某些实施方案中,金生长层940具有约5μm到约20μm的厚度。
图33N说明已经去除了所述光阻层935以暴露所述电极开口943。现在通过使用电化学蚀刻去除所述牺牲层902来从所述晶片901中去除MEMS膜。
图34A-34E说明一种具有两个金属层的MEMS膜的实例。图34A说明沉积在第一聚合物层和硅基阻挡层953上方的第一金属层915。将这些迹线放置在不同于这些电极的金属层中,这可通过从等势中心点分配迹线来改进电极的表面上的电势分布。例如,可将电势或电流施加于所述垫959,所述电流顺着所述迹线315朝一个给定电势的等势交叉点955行进。从等势交叉点955起,电流行进到电势彼此类似的四个末端954中的每一个。
图34B说明第二硅基阻挡层920的涂敷。第二硅基阻挡层920包括被成形为与末端954和垫959的端部对准的数个通孔917。
图34C说明将第二金属层涂敷到第二硅基阻挡层920。第二金属层包括这些电极120和这些接触垫145。每个电极120均包括通过通孔917与第一金属层915接触的多个接触点977。在其它实施方案中,这些电极120不包括接触点977,且电极120通过位于电极120的主体内的通孔917与第一金属层915接触。
图34D说明涂敷第三硅基阻挡层和第二聚酰亚胺层930。第三硅基阻挡层和第二聚酰亚胺层930包括界定这些电极120和这些接触垫145的穿孔982。
图34E说明所述完整的MEMS膜。第二聚酰亚胺930界定这些电极120和这些接触垫145。在某些实施方案中,使用第二金属层改进可允许的电极尺寸、定向和数量,因为将这些迹线移动到单独层使得所述电极金属层内没有表面区域,从而使得移动和设置电极具有更大自由。
图35A说明所述刺激导针100的示例性近端180。在某些实施方案中,可将这些近端接触件190实施为一种MEMS膜。将近端接触件190实施为MEMS膜可降低近端180的直径并且改进近端接触件190的可制造性。近端180可被成形以兼容现有的延伸电缆,诸如Medtronic37081电缆。这些延伸电缆可将刺激导针100与所述可植入刺激器122(可为例如MedtronicActiva PC)耦合。在某些实施方案中,近端180可被成形以兼容延伸电缆,所述延伸电缆与Medtronic 37081相比,在这些接触件之间具有更小节距。可使用上述MEMS膜制造方法制造近端180的MEMS膜1910。例如,可将近端MEMS膜1910成形为平坦膜,所述平坦膜被预模制为圆柱形状并且用聚合物或环氧树脂回填。图35B从不同角度说明近端180。
如图35A和35B中说明,MEMS膜1910包括远端部分1915,所述远端部分1915结合将MEMS膜1910电耦合到这些导线160的多个接触垫145,所述导线160延展穿过导针主体150朝向刺激导针100的远端。MEMS膜1910的近端部分1915可包括多个近端接触件190。这些近端接触件190可与一个或多个在MEMS膜1910的远端部分1915上的接触垫145电通信。在某些实施方案中,这些接触垫145是环形电极。MEMS膜1910的近端部分1911和远端部分1915可通过一个或多个互连件1925彼此耦合。将近端部分1911的这些接触件190与远端部分1915的这些接触件145电耦合的迹线可容置在互连件1925内。在某些实施方案中,冗余迹线包括在至少一个互连件1925内。冗余迹线可帮助防止当一个互连件1925断裂时发生装置故障。通过所述刺激导针100的近端180界定一个管腔1950。管腔1950可被成形以限制植入探针的通过,这可在植入期间对刺激导针100提供硬度。
在某些实施方案中,近端180可包括远离这些近端接触件190的硬度区域。硬度区域可介于约1cm与约5cm之间或介于约1.5cm与约2.5cm之间,例如基本上2cm。刚性区域可帮助神经外科医师将近端180推入延伸电缆的承口端。
在某些实施方案中,可使用上述电镀沉积方法将这些近端接触件190加厚。将近端接触件190加厚可有利于将延伸电缆重复耦合到近端180,因为所述加厚的金属层可改进近端接触件的耐擦伤性,从而使得近端接触件190更可靠且更耐用。在某些实施方案中,本文所述的MEMS膜技术还可用于实施延伸电缆。
在某些实施方案中,可将一种MEMS膜设置在与所述主体150耦合的封装管内。图36说明一种设置在封装管内的示例性MEMS膜110。MEMS膜110可包括上面可耦合有多个接触件的多个结合垫1961。在某些实施方案中,结合垫1961是类似于这些电极120的金属表面。在某些实施方案中,内部MEMS膜10在被成形为圆柱体时,其直径可小于例如由图34A中说明的MEMS膜110形成的圆柱体,其中MEMS膜110没有设置在封装管中。经封装MEMS膜100的直径可介于约0.5mm与约1.5mm之间。内部MEMS膜110还可包括多个接触垫145。
图37A和37B说明一个接触件1970的两个视图。在某些实施方案中,接触件1970可相对厚于一个电极120。可通过用管腔将一个铂圆柱体纵向分割为多个区段来形成接触件1970。在某些实施方案中,所述铂圆柱体可具有介于约0.5mm与约1.5mm之间的内径和介于约0.7mm与1.7mm之间的外径。在某些实施方案中,铂圆柱体的壁约0.2mm厚。可通过将铂圆柱体激光微加工将所述铂圆柱体划分为多个接触件1970。在某些实施方案中,这些接触件1970包括铂、钛或具有氧化铱涂层的其它导电材料。
图38A和38B说明这些接触件1970与MEMS膜1955的耦合。如所说明,一个接触件1970与每个结合垫1961耦合。在某些实施方案中,这些接触件1970通过例如激光焊接、热压缩结合、超声结合、导电胶合、导线结合或钎焊与这些结合垫1961耦合。图38B说明耦合到每个结合垫1961的一个接触件1970。在某些实施方案中,每个接触件1970远厚于所述MEMS膜110。一旦与所述MEMS膜110耦合,这些接触件1970通过嵌入在MEMS膜110内的多条迹线电耦合到这些接触件145。在某些实施方案中,这些接触件1970在所述MEMS膜110被成形为圆柱体之后与MEMS膜110耦合且例如通过用聚合物回填所述界定的管腔而具有刚性。在某些实施方案中,这些结合垫1961基本上具有与耦合MEMS膜110的这些接触件1970的部分相同的尺寸。在其它实施方案中,这些结合垫1961可大于或小于与MEMS膜10耦合的这些接触件1970的部分。在某些实施方案中,这些接触结合垫1961可为圆柱形接触件,或包括不同尺寸和几何形状,其中某些尺寸专用于刺激,而其它尺寸专用于记录。
图38C说明用多个接触件1970将多条导线160耦合到所述MEMS膜110。这些导线160可随着延展所述主体150的长度而盘绕。导线160可与每个接触垫145耦合。图38D说明一种示例性刺激导针,其具有一种设置在封装管内的MEMS膜。所述封装管1990封装所述MEMS膜110,包括这些接触垫145和这些导线160的端部。当封装在所述管1990中时,这些接触件1970外露并且可与管1990的外表面齐平。管1990可与主体150齐平。在某些实施方案中,可通过用环氧树脂包覆MEMS膜110来形成管1990。包覆可将这些接触件1970固定到MEMS膜110,同时将这些接触件1970的表面保持外露以将电流传导到所述目标部位。包覆还可将这些接触件145和多条导线160电隔离。
本文已经描述了微电极装置的各个实施方案。这些实施例是通过实例的方式给出并且不限制本发明的范围。已经描述的实施例的各个特征可以用各种方式组合以产生数种附加的实施例。另外,虽然已经描述了所公开实施例使用的各种材料、大小、形状、植入位置等,但是在不超出本发明的范围的情况下也可利用除所公开之外的其它材料、大小、形状、植入位置等。
可急性或慢性地使用本文描述为急性或慢性的多个装置。这些装置可在诸如手术期间的这些周期植入且然后被去除。这些装置可在多个持延长周期或无限制地植入。还可急性地使用本文描述为慢性的任何装置。
本发明在本申请中描述的特定实施例方面没有限制,所述实施例旨在说明各个方面。在不脱离本发明的精神和范围的情况下,可进行修改和变更。功能上等效的方法和设备可存在于本发明的范围内。这些修改和变更将属于所附权利要求书的范围。本发明的主题包括本发明要求的等效物的全范围。本发明不限于可改变的特定方法、反应剂、化合物成分或生物系统。本文使用的术语仅用于描述特定实施例,且不旨在有所限制。
关于本文中基本上任何复数形式或单数形式术语的使用,复数形式可包括单数形式或单数形式可包括适用于上下文或申请的复数形式。
一般来说,本文所使用的术语和尤其在所附权利要求书中(例如,所附权利要求书的主体)一般希望为“开放”术语(例如,术语“包括”应解释为“包括但不限于”,术语“具有”应解释为“至少具有”,术语“包括”应解释为“包括但不限于”等)。涉及所述主题的权利要求书可包括使用引导性短语“至少一个”及“一个或多个”以引入权利要求叙述。然而,这些短语的使用不应被解释为暗示:通过不定冠词“一个(a/an)”引入权利要求叙述会将包括这种所引入权利要求叙述的任何特定权利要求限于仅包括一个这种叙述的多个实施例,即使相同权利要求包括引导性短语“一个或多个”或“至少一个”和不定冠词(诸如“一个(a/an)”)(例如,“一个(a)”和/或“一个(an)”通常应被解释为表示“至少一个”或“一个或多个”);此同样适用于用于引入权利要求叙述的定冠词的使用。另外,即使明确叙述了具体数量的所引入权利要求叙述,但是这种叙述可至少表示所叙述的数量(例如,仅仅叙述“两种叙述”而无其它修饰词表示至少两种叙述或两种或更多种叙述)。另外,在其中使用类似于“A、B和C等中的至少一个”的惯用语的实例中,一般这种构造将包括(但不限于)单独具有A、单独具有B、单独具有C、具有A和B一起、具有A和C一起、具有B和C一起,和/或具有A、B和C一起,等的系统。在其中使用类似于“A、B或C等中的至少一个”的惯用语的实例中,一般这种构造将包括(但不限于)单独具有A、单独具有B、单独具有C、具有A和B一起、具有A和C一起、具有B和C一起,和/或具有A、B和C一起,等的系统。任何呈现两个或两个以上替代项的转折词和/或短语(无论在描述、权利要求书或附图中)可预期包括所述项中的一项、所述项中的任一项或两个项的可能性。例如,短语“A或B”包括“A”或“B”或“A和B”的可能性。
另外,当按照马库什组(Markush group)来描述本发明的多个特征或多个方面时,也按照马库什组的个别成员或成员子组来描述本发明。
本文所公开的任何范围还涵盖了任何和全部可能的子范围以及子范围的组合。任何列举的范围均可易于被辨识为充分描述并且实现相同范围被细分为至少相等的两半、三份、四份、五份、十份等。作为非限制性实例,本文讨论的每个范围均可易于细分为下面的三分之一、中间的三分之一和前面的三分之一等。诸如“多达”、“至少”、“大于”、“小于”等的语言包括所叙述的数量并且是指随后可被细分为如上文所讨论的子范围的多个范围。最后,一个范围包括每个个别成员。
本文描述的技术的一个或多个或其任何部分可在计算机硬件或软件或二者的组合中实施。这些方法可使用遵循本文所述的方法和图式的标准编程技术在计算机程序中实施。程序代码应用于输入数据以执行本文所述的这些功能并且产生输出信息。输出信息应用于诸如显示监控器的一个或多个输出装置。每个程序可用高级程序语言或面向对象编程语言来实施以与计算机系统通信。然而,如果需要,这些程序可用汇编或机器语言来实施。在任何情况中,所述语言可为编译或解译语言。另外,所述程序可在经编程用于所述目的的专用集成电路上运行。
每种这样的计算机程序均可存储在可由通用或专用可编程计算机读取的存储介质或装置(例如ROM或磁盘)上以在计算机读取所述存储介质或装置来执行本文所述的步骤时用于配置和操作计算机。在程序执行期间,计算机程序还可驻留在缓存或主存储器中。本文所述的分析、预处理和其它方法还可被实施为配置有计算机程序的计算机可读存储介质,其中如此配置的存储介质使得计算机以具体且预定义的方式操作来执行本文所述的功能。在某些实施例中,计算机可读介质在本质上是(例如)有形有且基本上非暂时性的,使得所记录的信息是以除了单独作为传播信号之外的形式来记录。
在某些实施例中,程序产品可包括信号承载介质。信号承载介质可包括在由例如处理器执行时可提供上述功能性的一个或多个指令。在某些实施方案中,信号承载介质可涵盖计算机可读介质,诸如(但不限于)硬盘驱动器、光盘(CD)、数字视频光盘(DVD)、数字磁带、存储器等。在某些实施方案中,信号承载介质可涵盖可记录介质,诸如(但不限于)存储器、读/写(R/W)CD、R/W DVD等。在某些实施方案中,信号承载介质可涵盖通信介质,诸如(但不限于)数字或模拟通信介质(例如光纤电缆、波导、有线通信链路、无线通信链路等)。因此,例如,程序产品可由RF信号承载介质来传达,其中信号承载介质由无线通信介质(例如符合IEEE 802.11标准的无线通信介质)来传达。
信号和信号处理技术中的任一种均可具有数字或模拟本质,或其组合。
虽然已经参考本发明的优选实施例具体示出并且描述了本发明的某些实施例,但是在不脱离本发明的范围的情况下,可在其中做出各种形式和细节改变。

Claims (25)

1.一种神经学导针,其包含:
平坦成形的圆柱形膜,所述平坦成形的圆柱形膜包含远端、近端以及多个电极,所述平坦成形的圆柱形膜进一步包含:
带状电缆,所述带状电缆从所述平坦成形的圆柱形膜的所述远端延伸到由所述平坦成形的圆柱形膜界定的管腔中;
第一聚合物层;
至少部分设置在所述第一聚合物层上方的第一硅基阻挡层;
至少部分设置在所述第一硅基阻挡层上方的第一金属层,所述第一金属层形成所述多个电极;
至少部分设置在所述第一金属层和所述第一硅基阻挡层上方的第二硅基阻挡层,所述第二硅基阻挡层界定第一多个穿孔;
第二聚合物层,所述第二聚合物层至少部分设置在所述第二硅基阻挡层上方并且第二聚合物层界定第二多个穿孔,所述第一多个穿孔与所述第二多个穿孔基本上对准以界定所述多个电极中的每一个;以及
设置在所述第一金属层上的第二金属层;以及
与所述平坦成形的圆柱形膜的所述近端耦合的管,管包含一个或多个定向标记。
2.根据权利要求1所述的导针,所述第一金属层形成多条迹线。
3.根据权利要求1所述的导针,所述第一金属层形成设置在所述带状电缆上的多个接触垫,所述多个接触垫中的每一个通过形成于所述第一金属层中的迹线与所述多个电极中的至少一个电耦合。
4.根据权利要求1所述的导针,其中所述第二金属层包含金,且所述第一金属层包含铂、氧化铱以及钛中的至少一种。
5.根据权利要求1所述的导针,其中所述第一和第二硅基阻挡层包含氮化硅、氧化硅、碳化硅、多晶硅、非晶硅、二氧化钛以及氧化钛(III)中的至少一种。
6.根据权利要求1所述的导针,其中所述第一和第二硅基阻挡层的厚度是介于约100nm与约2μm之间。
7.根据权利要求1所述的导针,其中所述平坦成形的圆柱形膜的圆柱形状至少部分由导线维持,所述导线将所述平坦成形的圆柱形膜的第一侧耦合到所述平坦成形的圆柱形膜的第二侧。
8.一种形成神经学导针的方法,所述方法包含:
通过以下步骤形成平坦膜,所述平坦膜包含多个电极和从所述平坦膜的远端延伸的带状电缆:
将第一硅基阻挡层至少部分沉积在第一聚合物层上方;
将第一金属层至少部分沉积在所述第一硅基阻挡层上方以形成所述多个电极;
将第二硅基阻挡层至少部分沉积在所述第一金属层和所述第一硅基阻挡层上方,第二硅基阻挡层界定第一多个穿孔;
将第二聚合物层至少部分沉积在所述第二硅基阻挡层上方,第二聚合物层界定第二多个穿孔,所述第一多个穿孔与所述第二多个穿孔基本上对准以界定所述多个电极中的每一个;以及
将第二金属层沉积在所述第一金属层上;
加热所述平坦膜;
将经加热平坦膜模制成圆柱体,所述圆柱体界定管腔;
以及
将所述带状电缆延伸到由所述圆柱体界定的所述管腔中;以及
将所述模制的平坦膜耦合到包含一个或多个定向标记的管。
9.根据权利要求8所述的方法,其进一步包含:
在所述第一金属层中的所述带状电缆上形成多个接触垫;
形成多条迹线,所述迹线将所述多个接触垫中的每一个电耦合到所述多个电极中的至少一个。
10.根据权利要求9所述的方法,其进一步包含将所述第二金属层沉积在所述多个接触垫上。
11.根据权利要求8所述的方法,其进一步包含:
通过在所述第二硅基阻挡层和所述第二聚合物层中蚀刻多个穿孔来界定所述多个电极中的每一个。
12.根据权利要求8所述的方法,其中所述第一和第二硅基阻挡层包含氮化硅、氧化硅、碳化硅、多晶硅、非晶硅、二氧化钛以及氧化钛(III)中的至少一种。
13.一种神经学导针,其包含:
界定管腔的平坦成形的圆柱形膜,所述平坦成形的圆柱形膜包含远端和近端,所述平坦成形的圆柱形膜进一步包含:
多个电极,其形成在金属层上,并通过沿着所述平坦成形的圆柱形膜的多个穿孔界定所述多个电极;以及
带状电缆,所述带状电缆从所述平坦成形的圆柱形膜的所述远端朝所述平坦成形的圆柱形膜的所述近端延伸到所述管腔中;以及
封装聚合物,填充所述平坦成形的圆柱形膜的所述管腔;以及
与所述平坦成形的圆柱形膜的所述近端耦合的管,管包含一个或多个定向标记。
14.根据权利要求13所述的导针,其包含设置在所述带状电缆上的多个接触垫,所述多个接触垫中的每一个电耦合到所述多个电极中的至少一个。
15.根据权利要求14所述的导针,其包含设置在所述多个接触垫中的每一个上的金层。
16.根据权利要求15所述的导针,其中所述金层的厚度介于约5μm与约50μm之间。
17.根据权利要求13所述的导针,其包含周边迹线,所述周边迹线部分包围所述多个电极中的每一个并且在两个或更多个位置与所述多个电极中的每一个耦合。
18.根据权利要求13所述的导针,其中所述一个或多个定向标记与所述多个电极中的至少一个或所述带状电缆对准。
19.根据权利要求13所述的导针,其中所述一个或多个定向标记是不透射线的。
20.根据权利要求13所述的导针,其中所述多个电极中的至少一个包含网格构形。
21.根据权利要求13所述的导针,其中所述多个电极中的至少一个包含圆角。
22.一种制造神经学导针的方法,所述方法包含:
提供平坦膜,所述平坦膜包含远端、近端、多个电极以及从所述平坦膜的所述远端延伸的带状电缆;
在平坦膜上限定多个穿孔以限定在金属层上形成的所述多个电极;
将所述平坦膜成形为圆柱体,所述圆柱体界定管腔;
将所述带状电缆延伸到由所述圆柱体界定的所述管腔中;
用封装聚合物填充所述管腔;以及
将不透射线染料设置在所述平坦膜上。
23.根据权利要求22所述的方法,其包含加热所述平坦膜。
24.根据权利要求22所述的方法,其包含将所述平坦膜的所述近端耦合到导管。
25.根据权利要求22所述的方法,其包含将探针与所述带状电缆耦合。
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