CN106572881B - 热传感器在双极电极上的替代放置 - Google Patents

热传感器在双极电极上的替代放置 Download PDF

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CN106572881B
CN106572881B CN201580019090.1A CN201580019090A CN106572881B CN 106572881 B CN106572881 B CN 106572881B CN 201580019090 A CN201580019090 A CN 201580019090A CN 106572881 B CN106572881 B CN 106572881B
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曹宏
特拉维斯·J·肖尔
亨利·H·李
普拉波德·马瑟
拉比·纳西夫
安德烈亚斯·丹德勒
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Abstract

一种用于组织消融的医疗器械可包括导管轴、被设置在所述导管轴上或被联接至所述导管轴的可扩张构件以及多个细长的电极组件，每个所述电极组件均被构造为柔性电路。所述可扩张构件可被配置成在未扩张形态和扩张形态之间转换。所述多个电极组件可被设置在所述可扩张构件的外表面上。所述多个电极组件中的每一个可包括与两个以上的电极相对齐的温度传感器。

Description

热传感器在双极电极上的替代放置
相关申请的交叉引用
本申请根据35U.S.C.§119要求于2014年2月4日提交的序列号为61/935,685的美国临时申请的优先权，其整个内容以引用方式并入本文。
技术领域
本发明关于医疗器械以及医疗器械的制造方法。更特别地，本发明关于用于组织消融的医疗器械。
背景技术
已开发出各种各样的体内医疗器械以用于医疗用途，如在血管内使用。这些器械中的一些包括导丝、导管等。这些器械是通过各种不同的制造方法中的任何一种进行制造并可根据各种方法中的任何一种进行使用。在已知的医疗器械和方法中，各自具有某些优点和缺点。持续地需要提供替代的医疗器械以及用于制造和使用医疗器械的替代方法。
发明内容
一种用于组织消融的医疗器械可包括导管轴和被设置在导管轴上的可扩张球囊，其中球囊可以在未扩张形态和扩张形态之间转换。医疗器械可包括多个细长的电极组件，每个电极组件均被构造为柔性电路，多个电极组件中的每一个可包括以至少第一和第二间隔开的阵列进行布置的多个电极，多个电极组件可被设置在球囊的外表面上。多个电极组件中的每一个可包括与阵列中的两个以上的电极对齐的一个以上的温度传感器。
一种用于组织消融的医疗器械可包括导管轴、被联接至导管轴的可扩张构件以及多个细长的电极组件，每个电极组件都被构造为柔性电路。可扩张构件可以在未扩张形态和扩张形态之间转换。多个电极组件可被设置在可扩张构件的外表面上，且多个电极组件中的每一个可包括位于至少一个电极下的至少一个温度传感器。
一种用于在身体通道内组织消融的医疗器械可包括具有纵轴线的导管轴、被联接至导管轴的可扩张构件以及多个细长的电极组件，每个电极组件均被构造为柔性电路。可扩张构件可在未扩张形态和扩张形态之间转换，且多个电极组件可被结合至可扩张构造的外表面。多个电极组件中的每一个可包括多个有源电极、多个接地电极和一个以上的温度传感器。温度传感器可与多个接地电极线性对齐。
上面有关一些实施例的概述并不旨在描述本发明的每个所公开的实施例或每个实施方式。下面的附图及具体实施方式更具体地举例说明了这些实施例。
附图说明
结合附图考虑下面的详细描述可更加完整地理解本发明，其中：
图1为实例组织消融器械的示意图；
图2A、2B和3为现有技术的电极组件的局部俯视图；
图4为示例性电极组件的局部俯视图；
图5为示例性电极组件的局部俯视图；
图6A和6B为示例性电极组件的俯视图；
图7为组织消融器械的示例性可扩张构件的立体图；
图8为示例性电极组件的一部分的俯视图；
图9为图8的局部截面视图；
图10A、10B、11、12和13为示例性电极组件的局部俯视图；
图14为示例性电极组件的局部截面视图；
图15A、15B和15C为分别通过图14的组件的横截面A-A、B-B和C-C截取的温度曲线图；以及
图16为在与示例性电极的中心相距不同距离的温度曲线图的图形表示。
虽然本发明可被修正成各种修改和替代形式，但是在附图中以示例方式示出的细节仍将进行详细描述。然而，应理解的是本发明并不旨在将本发明限制为所述的特定实施例。相反地，本发明旨在涵盖落在本发明的精神和范围内的所有修改、等同物和替代方案。
具体实施方式
应参照不一定是按比例绘制的附图阅读下面的描述，其中在多个视图中，相同的参考数字表示相同的元件。具体实施方式和附图旨在说明而非限制所要求保护的本发明。本领域的技术人员将认识到所描述和/或所示的各种元件可在不脱离本发明范围的前提下进行各种组合和配置。具体实施方式和附图示出所要求保护的本发明的的实例实施例。
对于下面定义的术语而言，这些定义应是适用的，除非在权利要求中或本说明书的其他地方给出了不同的定义。
在本文中，不论是否明确指出，所有数值都被假定为可用术语“大约”进行修饰。在使用数值的上下文中，术语“大约”通常是指本领域的技术人员将认为等同于所引用的值(即，具有相同功能或结果)的一个值的范围。在许多情况下，术语“大约”可包括被四舍五入至最近的有效数字的数值。除非另有规定外，其他对术语“大约”的使用(即在除了使用数值以外的上下文中)可被假定为具有其普通和习惯定义，如可根据本说明书的上下文所理解的且与其保持一致。
经端点表述的数值范围包括在该范围中的所有数字(例如，1至5包括1、1.5、2、2.75、3、3.80、4和5)。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
要注意的是在本说明书中对“一个实施例”、“一些实施例”、“其他实施例”等的参照表示所描述的实施例可能包括特定的特性、结构或特征，但每个实施例可能不一定包括特定特性、结构或特征。此外，这种短语不一定是指相同的实施例。进一步地，当特定特性、结构或特征是结合一个实施例进行描述时，无论是否明确地进行描述，除非明确说明与此相反，结合其他实施例实现这种特性、结构或特征是在本领域的技术人员的知识范围内的。即，下面描述的各种独立元件，即使不是在一个特定组合中明确示出的，仍可被认为是彼此之间可进行组合或布置，从而形成其他额外的实施例或补充和/或丰富所描述的实施例，如本领域的普通技术人员所理解的那样。
某些治疗旨在进行组织消融。在一些实例中，组织消融可包括临时或永久中断或修改选择神经功能。在一些实施例中，神经可以是交感神经。一种实例治疗为肾神经消融，其有时被用于治疗如高血压、充血性心脏衰竭、糖尿病或受高血压或盐潴留影响的其他状况或与其相关的状况。肾脏产生交感神经反应，其可能增加水和/或钠的不需要的潴留。例如，交感神经反应的结果可能是血压的升高。消融运行至肾脏的一些神经(例如，被设置在邻近肾动脉处或以其他方式沿肾动脉设置的)可减少或消除这种交感神经反应，其可使相关联的不期望的症状相应减少(例如，血压降低)。
本发明的实施例涉及通常用于治疗靶组织的发电和控制器械，从而实现治疗效果。在一些实施例中，靶组织是含有或紧邻神经的组织。在其他实施例中，靶组织为交感神经，包括，例如，邻近血管而设置的交感神经。在其他实施例中，靶组织是内腔组织，其还进一步地包括患病组织，如在动脉疾病中所找到的。
在本发明的一些实施例中，以靶剂量输送能量的能力可被用于神经组织，从而实现有益的生物反应。例如，已知慢性疼痛、泌尿功能障碍、高血压和各种各样的其他持续情况已知会通过神经组织的操作受到影响。例如，已知慢性高血压可通过禁用紧邻肾动脉的过度的神经活动力而对可改善或消除的药物处理作出反应。也已知神经组织并不天然地拥有再生特征。因此，可通过使神经组织的传导路径断裂而有利地影响过度的神经活动力。当使神经传导路径断裂时，特别有利的是避免损害邻近的神经或器官组织。用于指导和控制能量剂量的能力非常适合于神经组织的治疗。无论是在加热还是在消融能量剂量时，如本文所描述和公开的精确控制能量的输送可被引导至神经组织。此外，能量的定向施用可能足以将神经作为标靶而无需与其实现精确接触，如当使用典型的消融探针时将需要的一样。例如，可在足够高的能使神经组织变性而不会导致消融和无需穿透内腔组织的温度下施用偏心加热。然而，可能需要配置本发明的能量输送表面以穿透组织并以类似于消融探针的方式输送消融能量，其中通过电力控制和发电器械控制精确的能量剂量。
在一些实施例中，去神经治疗的效力可通过在治疗之前、期间和/或之后进行测量的方式进行评估，从而使治疗的一个或多个参数适合于特定的患者或识别进行额外的治疗的需要。例如，去神经系统可包括用于评估治疗是否已引起或正在引起在靶或紧邻组织中的神经活动力的降低的功能，其可能提供用于调整治疗参数或指出进行额外的治疗的必要性的反馈。
本文所述的器械和方法中的许多是相对于肾神经消融和/或调制进行讨论。然而，可以预期的是器械和方法也可用于其他治疗位置和/或应用中，其中按照需要，交感神经调制和/或其他组织调制包括加热、活化、阻断、中断或消融，例如但不限于：血管、尿液脉管或在经套管针和导管到达的其他组织。例如，本文所述的器械和方法可被应用至增生组织消融、心脏消融、疼痛管理、肺静脉隔离、肺静脉消融、肿瘤消融、良性前列腺增生疗法、神经激励或阻断或消融、肌肉活动性的调制、组织的热疗或其他加温等。所公开的方法和器械可被施加至任何相关的医疗器械，其涉及人类和非人类受试者。术语调制是指可改变所影响的神经和其他组织的功能的消融和其他技术。
图1为实例交感神经消融系统100的示意图。系统100可包括交感神经消融器械120。交感神经消融器械120可用于消融邻近肾脏K设置的神经(例如，肾神经)(例如，围绕肾动脉RA设置的肾神经)。使用中，交感神经消融器械120可通过诸如主动脉A的血管被推进至肾动脉RA内的一个位置。这可包括推进交感神经消融器械120通过导引护套或导管14。当根据需要定位时，交感神经消融器械120可被激活以激活一个以上的电极(未示出)。这可包括将交感神经消融器械120操作性地联接至包括RF发生器的控制单元110，以便将所需的激活能量供应给电极。例如，交感神经消融器械120可包括具有可被连接至控制单元110上的第二连接器22和/或被联接至控制单元110的电线24的第一连接器20的电线或传导构件18。在至少一些实施例中，控制单元110也可用于供应/接收适当的电能和/或信号以激活一个以上被设置在或接近交感神经消融器械120的远端的传感器。当被适当地激活时，一个以上的电极能够消融如下文所述的组织(例如，交感神经)且一个以上的传感器可被用于检测所需的物理和/或生物参数。
交感神经消融器械120可包括细长管状构件或导管轴122。在一些实施例中，细长管状构件或导管轴122可被配置成在导丝或其他细长医疗器械上可被滑动地推进至靶位。在一些实施例中，细长管状构件或导管轴122可被配置成在导引护套或导管14内可被滑动地推进至靶位。在一些实施例中，细长管状构件或导管轴122可被配置成在导引护套或导管14或其组合内，在导丝上被推进至靶位。可扩张构件130可被设置在细长管状构件或导管轴122的远侧区域处、其上、围绕其或其附近。在一些实施例中，可扩张构件130可以是顺应性或非顺应性球囊。在一些实施例中，可扩张构件130可以在未扩张形态和扩张形态之间转换。
可能需要使用包括一个以上电极组件联接至其的球囊的医疗器械，如上所述。然而，在一些情况下，电极组件可能包括相对刚性和/或庞大的材料或元件。因此，当在治疗术后球囊缩放时，电极组件则可能趋于平坦化和/或加宽。当如此进行配置时，一个以上的电极组件和/或其部件或边缘在将医疗器械(例如，包括附着的电极组件)向近侧缩回至导引导管中时可能卡在导引导管的边缘上。本文所公开的医疗器械包括可减小电极组件的大小以及电极组件或医疗器械的其他结构在被缩回，例如，至导引导管中时“卡”在导引导管(或其他器械)的端部上的可能性，从而产生减少的取回力的结构特征。
电极组件可被布置在可扩张构件上且每个组件可包括接地电极10、正电极12和温度传感器或热敏电阻26，且它们中的每一个都具有一个以上。一些现有技术的电极对设计由电极片70组成，该电极片70具有与多个正电极12间隔几毫米的多个接地电极10，其中热敏电阻26被放置在电极之间，如在图2A中所示。这允许当激活各个电极时进行准确的温度检测，这产生了一致的损伤。每个单独的电极对可单独地进行激活，这导致在脉管周围的交错治疗。当电极组件被置于球囊导管上时，其可围绕每个热敏电阻进行有线连接以独立地进行激活，如在图2B中所示。
在其他应用中，可能需要更完整和圆周的治疗。在这些应用中，电极对可进行布置以在电极对内(如通过箭头50所示)，以及在电极对之间(如通过箭头60所示)激励。见图3。在这种情况下，电极对之间不具有在激活期间监视温度的热敏电阻。
为了监视电极对之间的温度，可在电极片70之间放置额外的热敏电阻26，如在图4中所示。然而，该布置需要使热敏电阻的数量加倍，其在球囊上需要额外的表面积，可增加球囊的刚度和轮廓并需要额外的电连接以完成用于额外的热敏电阻的电路。热敏电阻可能是电极组件的最大部件。例如，热敏电阻可能是0.02英寸(0.0508厘米)乘0.04英寸(0.1016厘米)并且厚度为0.006英寸(0.01524厘米)。当被置于电极之间时，热敏电阻可增加电路的轮廓和电路面积/质量。该电路还可使可扩张构件难于折叠，需要更大的导管或护套。
在一些实施例中，双极电极结构上的温度传感器的偏心放置可减少柔性电路轮廓并改进球囊的可折叠性，这允许球囊通过较小的护套或导管。偏心地或与电极成一直线地移动温度传感器可允许可扩张构件沿两行电极的中心折叠，而不会破坏温度传感器。在球囊的收缩过程中，可用设置有电极的柔性电路的脊拉回温度传感器。在两行电极之间的中间部分更容易进行折叠。该结构可允许器械通过更小的护套或导管进行插入和取回。
在图5中示出了实例温度传感器的放置，其对在电极对内和电极对之间的激活提供了完全的温度监视，而不会增加温度传感器的数量。温度传感器226，如热敏电阻，被置于接地电极210下，如在图5中所示。一层绝缘材料，如聚酰亚胺可被置于接地电极210和温度传感器226之间。在该布置中，每个温度传感器226可监视在电极对内电极激活50以及在电极对之间电极激活60的温度，如在图6A所示。激励频率和序列可通过发生器的硬件和软件进行控制，其可优化温度准确度且可减少在电极激活和温度感测过程中的串扰的量。在一些实施例中，可能需要较长的球囊。电极组件140可进行延长，且可按沿电极长度延伸的阵列添加额外的电极222，包括接地电极210和有源正电极212，以及温度传感器226以监视整个长度的温度。见图6B。电极阵列可按彼此平行的方式或按彼此成角度的方式进行定向且可间隔开来。在一些实施例中，在电极210、212阵列之间的电极组件的区域145缺乏电路。该缺乏电路的区域145可有助于进行电极组件的折叠。
每个电极组件140可包括在基层202的顶部上层叠的多个离散传导迹线。多个离散传导迹线可包括接地电极迹线210、有源或正电极迹线212和温度传感器迹线214。接地电极迹线210可包括细长接地电极支撑件216且有源电极迹线212可包括细长有源电极支撑件217。电极支撑件216、217在其近端宽度可逐渐变细以提供所需数量的灵活性，然而，这不是必需的。通常，在示出缩颈处的迹线的曲率可被优化以减少球囊再捕获力以及减少任何钩住可能存在的更锐利轮廓的可能性。迹线的形状和位置也可被优化以向作为整体的电极组件140提供尺寸稳定性，从而在布置和使用的过程中避免变形。
如在图6B中所示，接地电极迹线210和有源电极迹线212的每一个可包括多个电极222。在一些实施例中，可为每个电极迹线设有至少一个电极，然而，也可使用更多或更少的电极。例如，在一些实施例中，可为每个电极迹线设有三个电极。见图11-13。在其他实施例中，可为每个电极迹线设置高达35个或更多的电极，如在图7和8中所示。多个电极222可在绝缘层206上方突出和/或延伸通过绝缘层206。在一些实施例中，多个电极222可包括被分别附接和/或电连接至细长有源电极支撑件217和细长接地电极支撑件216的至少一个有源电极和至少一个接地电极。在一些实施例中，多个电极222可被附接和/或电连接至细长接地电极支撑件216，从而界定多个接地电极和/或细长有源电极支撑件217，从而界定多个有源电极。
在一些实施例中，多个电极222可以是约0.030mm厚至约0.070mm厚。在一些实施例中，多个电极222可以是约0.051mm厚。在一些实施例中，多个电极222可在绝缘层206上方延伸约0.020mm至约0.050mm。在一些实施例中，多个电极222可在绝缘层206上方延伸约0.038mm。此外，每个电极可具有圆角以减少钩挂其他器械和/或组织的倾向。尽管上文对于多个电极以及与其相关联的迹线的描述已经在双极电极组件的背景下进行过，本领域的技术人员仍将认识到相同的电极组件也可在单极模式中运行。例如，作为一个非限制性实例，与有源电极迹线212相关联的多个电极可被用作单极电极，其中接地电极迹线210在那些电极的通电过程中是断开的。
在一些实施例中，温度传感器226可具有约0.100mm至约2.000mm的长度以及约0.100mm至约0.800mm的宽度。在一些实施例中，温度传感器226可具有约1.000mm的长度以及约0.500mm的宽度。在另一个实施例中，温度传感可具有约0.2mm的长度以及0.01mm的宽度。也可考虑其他大小和/或尺寸。
在一些实施例中，电极可按很小的角度在球囊周围倾斜以形成围绕球囊的螺旋形态，其可有助于在治疗后球囊进行收缩。例如，如在图7中所示，多个电极组件140可按一个角度定位于可扩张球囊130上，如在扩张形态中所示。电极组件140可被配置成，通过电极组件施加的能量产生可能或可能不会重叠的治疗。通过电极组件140施加的治疗可能是沿纵轴线L-L为周向连续或不连续的。由电极组件，如在图7中所示的电极组件140施加的能量可纵向、周向，和/或以其他方式至少在一定程度上重叠。在图7和8中所示的电极组件140可包括矩形的基层202。这不旨在进行限制。可考虑其他形状。额外地，电极组件140可包括多个延伸通过其的开口以提供增加的灵活性且组件的部分可包括圆形或弯曲的角、过渡部和其他部分。在一些情况下，开口和圆形/弯曲的特征可加强组件阻止来自于可扩张构件130的分层，如在一些情况下，当可扩张构件130重复扩张和塌缩(其也可以是指从保护性护套展开和收回至保护性护套中)时所可能发生的，如当在手术过程中治疗多个位点时所需要的。
在图8中示出了一个实例电极组件140。如在图8中所示，每个电极组件140可包括在传感器迹线214上的一个以上的温度传感器226和多个电极222，一些被设置在接地阵列或迹线210上且一些被设置在有源或正阵列或迹线212上。传感器迹线214可中心定位于电极组件140上。在其他实例中，传感器迹线214可邻近阵列或迹线210、212中的一个定位。每个电极组件140包括近侧尾部180，其可包括延伸远离可扩张构件130的近端且沿导管轴122延伸至导管轴122的近端的狭窄区域。
在一些实施例中，温度传感器226可以是热敏电阻。如在图9中所示，温度传感器226可被设置在电极组件140的非组织接触侧(即，底侧)上。因此，当被结合至消融器械120中时，温度传感器226可在电极组件140和可扩张构件130之间被俘获。这是有利的，因为在表面安装的电气部件，如热敏电阻，可通常具有尖锐的边和角，其可卡在组织上且可能在球囊布置和/或收缩中引起问题。该布置还可使钎焊接头免于与血液相接触，这是因为焊剂通常是非生物兼容的。
温度传感器226处的电极组件140的大小和/或厚度可创建从可扩张构件130的外表面向外延伸的突出。在治疗术后，可扩张构件130可塌缩为塌缩输送形态，如本文进一步所讨论的，且消融器械120可被缩回在导引护套或导管14内。显著突出可能使缩回至导引护套或导管14中更加困难并且/或着与其他方式相比需要更大直径的导引护套或导管14。此外，对于输送和收回而言，突出可能会对可扩张构件130的可折叠特征产生负面影响。
图9示出实例电极组件140的局部俯视图及其横截面。在图9的截面视图中，图的底部为电极组件140的一部分，其可面向，可接触和/或可被直接附接和/或结合至可扩张构件130的外表面。在一些实施例中，绝缘的基层202可为电极组件140提供基础。基层202可由聚合物，如聚酰亚胺构造而成，但是也可考虑其他材料。在一些实施例中，基层202可以是约0.010mm厚至约0.020mm厚。在一些实施例中，基层202可以是约0.015mm厚。也可考虑其他合适的厚度。供参考，基层202可形成电极组件140的底侧的大部分，其可面向，可接触和/或可被直接附接和/或结合至可扩张构件130的外表面。
第一传导层204可包括在基层202上层叠的多个离散传导迹线。在一些实施例中，多个离散传导迹线可通过非传导材料横向地分隔开。传导层204的多个离散传导迹线可包括，例如，一层电解铜或轧制退火铜。也可考虑其他合适的传导材料。在一些实施例中，传导层204和/或多个离散传导迹线可以是约0.010mm至约0.030mm厚。在一些实施例中，传导层204和/或多个离散传导迹线可以是约0.018mm厚。也可考虑其他合适的厚度。第一传导层204可进行蚀刻以形成用于可被置于第一传导层上的温度传感器226的正和接地连接。
第二传导层304可被设置在基层202上，且绝缘层206可离散地或连续地层叠在第二传导层304的顶部上，使得第二传导层304可在基层202和绝缘层206之间流体密封。换句话说，绝缘层206可形成电极组件140的顶侧或表面，其可背对可扩张构件130的外表面。在基层202、第一传导层204、第二传导层304和绝缘层206之间的关系是说明性的，且可考虑其他构造。类似于基层202，绝缘层206可由聚合物，如聚酰亚胺构造而成，然而也可考虑其他材料。在一些实施例中，绝缘层206可以是约0.010mm厚至约0.020mm厚。在一些实施例中，绝缘层206可以是约0.013mm厚。也可考虑其他合适的厚度。在一些实施例中，绝缘层206可以是完全或部分的聚合物涂层，如PTFE或硅酮。也可考虑其他材料。
电极组件140可被构造为具有多层的柔性电路。这些层可以是连续的或不连续的(即由离散部分所组成)。电极组件140可以是多层结构，其中电极222在(远离可扩张构件的)上表面上且温度传感器，如温度传感器226在(紧靠可扩张构件的)下表面上。电极组件140可包括一层以上的聚合物以及一层以上的传导材料。如在图9中的横截面中所示，电极组件140可包括两个聚合物层202、206、两个传导层204、304、温度传感器226和电极222。聚合物和传导层可以是被粘附性地结合至传导层204、304的聚合物层202、206的层压片材。在一些实施例中，两个这种片材可用粘合剂层205结合在一起。如在图9中所示，两个聚合物/传导片材可通过聚合物侧紧靠传导侧的方式结合在一起，从而当从上表面开始截取横截面时(远离可扩张构件的)，产生交替的聚合物206-传导304-粘合剂205-聚合物202-传导204结构。
第二传导层304可进行蚀刻以形成用于接地和正电极222对的迹线。可产生通道以将第二传导层304的电极接地迹线连接至第一传导层204的温度传感器226的接地迹线。温度传感器226可被焊接至第一传导层204上。绝缘层206可进行削磨以形成凹部208，从而允许进行镀金以形成金电极222。
在其他实施例中，如在图10A中所示，接地电极的凹部中的一个可进行移除且温度传感器226可位于凹部本应在的区域中。凹部208可按任何方向进行定向。第一传导层204可被设计成与温度传感器226共享接地迹线210，同时可形成新的迹线以用于温度传感器的正连接。对于可能需要更多温度传感器的较长的电极，温度传感器可沿接地迹线210进行定位且可彼此平行地进行有线连接，如在图10B中所示。或者，当使用多个温度传感器时，其可单独地进行有线连接(未示出)。
在一些实施例中，电极组件140可沿预定的折叠线进行设置或以其他方式限定预定折叠线，可扩张构件130可在缩放后沿该预定折叠线进行折叠。在一些实施例中，预定折叠线可有助于进行可扩张构件130的再折叠。在一些实施例中，电极组件140可基本上线性地沿可扩张构件130的整个长度，或者与沿可扩张构件130的整个长度的纵轴线L-L成角度地延伸。在一些实施例中，电极组件可在近侧区中平行于纵轴线延伸，接着在远侧区中被弯曲为成角度的取向(未示出)。电极组件140可使球囊沿电极组件140的线折叠，这减少了将消融器械120收回至导引护套或导管14中所需的收回力，并允许使用较小直径的导引护套。例如，可使用6Fr或7Fr导引导管14，这与之前已使用8Fr导引导管的某些手术(例如，肾手术)相比提供了优势。电极组件140还可减少剪切力或改进球囊的再折叠轮廓的效率，从而减少了电极组件140从可扩张构件130发生的分层。
在一些实施例中，电极组件140包括单行或单个阵列的正电极212和单行或单个阵列的接地电极210，如在图8中所示。在其他实施例中，电极组件340、440可包括纵向间隔开的电极片308、336和408、436，如在图11A和11B中所示。从远侧电极片308、408向近侧移动、组合的基层202、传导层304和绝缘层206可减少至中间尾部328、428的横向宽度。继续从中间尾部328、428向近侧移动、组合的基层202、传导层304和绝缘层206可增加横向宽度以形成近侧电极片336、436。可按类似于远侧电极片308、408的方式构造近侧电极片336、436。然而，如图所示，近侧电极片336、436可关于沿电极组件340、440延伸的中心纵轴线横向偏离远侧电极片308、408。
从近侧电极片336、436开始，组合的基层202、传导层304和绝缘层206的横向宽度可减少以形成近侧尾部338、438。近侧尾部338、438可包括使得能够联接至一个以上子线束和/或连接器并最终至控制单元110的连接器(未示出)。这些线中的每一根都可沿关于电极组件340、440的中心轴线平行的各轴线延伸。
电极组件340、440可具有远侧电极片308、408和近侧电极片336、436绕电极组件340、440的中轴线的对称或不对称的布置。进一步地，两个电极片的接地电极210可沿中心轴线与接地线大致对齐。已发现该布置可能具有某些优点。例如，通过基本上共用相同的接地迹线，近侧尾部的宽度可以仅是中间尾部宽度的约1.5倍，而不是在如果每个电极片具有独立接地线情况下的约2倍宽。因此，近侧尾部338、438可以比位于并排位置上的两个中间尾部328、428更窄。
图11A示出具有线性行的正电极212和接地电极210的电极组件340，其中包括基层202的基板材料在行之间延伸。图11B示出类似的电极组件440，其在线性行的电极212、210之间切掉基板材料。在行电极之间移除基板材料减少了必须要进行折叠的电路的质量。当被设置在球囊上时，与电极组件340相比，电极组件440可提供增强的可折叠性，这是因为在线性行的电极之间缺少基板可允许在电极行之间更容易地进行折叠，其中温度传感器226是与接地电极210一起折叠的。该结构可允许器械通过较小的护套或导管进行插入和收回。然而，甚至在行电极之间存在有基层202的情况下，如在图11A中所示，与在图2A和2B中所示的现有技术的电极组件相比，远离中心移动温度传感器226并将其移至一行电极上提供了增强的可折叠性。在图11A和11B中所示的电极组件340、440还示出与最近侧的接地电极210成直线放置且位于其近侧的温度传感器226。该配置以两个线性行提供了电极和温度传感器，其可有助于沿在行电极之间的线折叠电极组件。
在一些实施例中，温度传感器226可以是溅射热电偶(例如，T型配置：铜/康铜)。在图12A和12B中所示的实施例中，温度传感器为热电偶426，其具有接近在接地迹线210上的中间电极的接合点。由于球囊的并置，中间电极可具有更少的变化且可具有比现有技术的中心位置更好的相关性或误差。在一些实施例中，热电偶可包括分层的铜和康铜。热电偶可由在两层之间的通过孔形成且可填充有焊料，其使通过孔成为热电偶接合点。和图11A和11B中示出的一样，图12A示出电极组件440，其具有被设置在接地迹线210和正迹线212之间的基板或基层402，而图12B则示出电极组件540，其移除了在两行正和负电极之间的基板。
热电偶接合点可被置于近侧接地电极上或在其附近，如在图13A和13B中所示。热接合点可由铜和康铜(T型)，而非金和康铜制成。然而，接合点接近于铜层，使得其可测量加热元件的精确温度。热电偶可基于在接合点的温度在两种不同金属的接合点生成电压差，如在本领域中已知的。在一些实施例中，等温接合点可形成于电极组件140的近端并与电极片和/或多个电极相间隔和热隔离。在一些实施例中，温度传感器226可形成为在传导层204内的电解铜的离散迹线。在一些实施例中，传感器迹线214的远端部分，且在一些情况下，整个传感器迹线214可由，例如，康铜(即，铜镍合金)、镍-铬或其他合适的传导材料制成。
图13A示出电极组件640的另一个实施例，其具有在基板或基层502上的平行的接地电极210和正电极212行。温度传感器526可以是热电偶，其在最近侧的接地电极210的近端具有接合点。图13B示出类似的电极组件740，在接地电极210和正电极212的行之间移除了基层502的一部分。
由于其球囊结构和双极能量输送，示例性装置在RF输送过程中在球囊上和在组织内部具有非常统一的温度曲线图。图14为具有电极822、传导层804和基层或基板802的简化模型电极组件840的截面视图。图15A-15C示出在30秒加热时的各种表面的热曲线图。图15A示出通过图14中的截面A-A的聚酰亚胺基层802的面。图15B示出通过图14中截面B-B的在铜传导层804和聚酰亚胺基层802之间的界面。图15C示出在图14中截面C-C处的球囊外直径。正如当比较图15A-15C时能看出的，温度曲线图横跨电极组件840的横截面为基本上恒定的。在球囊1501中心处的温度接近在电极1502处的温度。由于该一致性，在球囊1501中心处的温度还接近于在电极组件1502边缘处的温度并与其具有很好的关联性。
图16示出在电极对1601中心处且在与中心相距各种距离处的温度。如能看出的，从电极对的中心至该行电极的边缘，温度基本上是恒定的。已发现代替中心温度测量的接近电极的温度测量适合温度控制，且同时能保持损伤的一致性。
在使用中，消融器械120可通过血管或身体通道被推进到邻近靶组织的位置(例如，在肾动脉内)，在一些情况下，这是在输送护套或导管14的帮助下进行的。在一些实施例中，靶组织可以是被设置在血管周围的一个以上的交感神经。在一些实施例中，控制单元110可被可操作地联接至消融器械120，其可被插入血管或身体通道中以使得可扩张构件130(具有多个电极组件300)可被置于邻近需要治疗的靶组织处。可根据常规的方法(例如，在透视导向下在导丝上进行)在邻近需要治疗的靶组织处放置消融器械120。当合适地进行定位时，可扩张构件130可从塌缩输送形态扩张至扩张形态，例如在使用球囊的情况下通过对流体加压2-10atm而实现。这可靠着血管壁放置/推动多个电极。可激活多个有源电极。消融能量可从多个有源电极进行传输通过靶组织(可对交感神经进行消融、调制或以其他方式影响交感神经处)并在双极配置中通过多个接地电极返回或在单极配置中通过共用接地电极返回。在治疗后，可扩张构件130可被塌缩到塌缩输送形态中以缩回至导引护套或导管14中并随后从血管或身体通道收回。
能够用于消融器械120(和/或本文所公开的其他器械)的各种部件的材料可以包括通常与医疗器械相关联的那些材料。为了简单的目的，下面的讨论参照消融器械120。然而，这并非意在限制本文所描述的器械和方法，因为讨论可以被应用到本文所公开的其他类似的管状构件和/或可扩张构件，和/或管状构件和/或可扩张构件的部件。
消融器械120和其各种部件可由金属、金属合金、聚合物(其某些示范例在下文中公开)、金属-聚合物复合材料、陶瓷、上述的组合等，或其他合适的材料制成。合适的聚合物的某些示范例可包括聚四氟乙烯(PTFE)、乙烯四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚甲醛(POM，例如，可得自DuPont的)、聚醚嵌段酯、聚氨酯(例如，聚氨酯85A)、聚丙烯(PP)、聚氯乙烯(PVC)、聚醚-酯(例如，可得自DSM工程塑料的)、醚或酯类的共聚物(例如，丁烯/聚(亚烷基醚)邻苯二甲酸酯和/或其它的聚酯弹性体，如可得自DuPont的)、聚酰胺(例如，可得自Bayer的或可得自Elf Atochem的)、弹性体聚酰胺、嵌段聚酰胺/醚、聚醚嵌段酰胺(PEBA，例如以商品名可得的)、乙烯醋酸乙烯酯共聚物(EVA)、有机硅、聚乙烯(PE)、Marlex高密度聚乙烯、Marlex低密度聚乙烯、线性低密度聚乙烯(例如)、聚酯、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚对苯二甲酸丙二醇酯、聚萘二甲酸乙二醇酯(PEN)、聚醚醚酮(PEEK)、聚酰亚胺(PI)、聚醚酰亚胺(PEI)、聚苯硫醚(PPS)、聚苯醚(PPO)、聚对苯二甲酰(例如，)、聚砜、尼龙、尼龙12(如可得自EMS American Grilon的)、全氟(丙基乙烯基醚)(PFA)、乙烯-乙烯醇、聚烯烃、聚苯乙烯、环氧树脂、聚偏二氯乙烯(PVDC)、聚(苯乙烯-b-异丁烯-b苯乙烯)(例如，SIBS和/或SIBS 50A)、聚碳酸酯、离聚物、生物相容性的聚合物、其它合适的材料或它们的混合物、组合、共聚物、聚合物/金属复合材料等。在某些实施例中，混合物可包括达约6％的LCP。
适当的金属和金属合金的某些示范例包括不锈钢(如304V、304L和316LV不锈钢)、软钢、镍钛合金(例如线性弹性和/或超弹性镍钛诺)、其它镍合金，如镍-铬-钼合金(例如，UNS：N06625如625、UNS：N06022如UNS：N10276如其他合金，等)、镍铜合金(如，UNS：N04400如400、400、400，等)、镍钴铬钼合金(例如，UNS：R30035如等)、镍钼合金(如，UNS：N10665如合金)、其它镍铬合金、其它镍钼合金、其它镍钴合金、其它镍铁合金、其它镍铜合金、其它镍钨或钨合金等、钴铬合金、钴铬钼合金(例如，UNS：R30003如 等)、铂富集不锈钢、钛、它们的组合等，或任何其它合适的材料。
如上本所述，在商业可得的镍钛或镍钛诺合金族中，有被指定为“线性弹性”或“非超弹”的一类，该类的化学性能尽管与普通形状记忆和超弹性种类类似，但可显示不同且有用的机械性能。线性弹性和/或非超弹性镍钛诺与超弹性镍钛诺的不同之处在于线性弹性和/或非超弹性镍钛诺不像超弹性镍钛诺那样在其应力/应变曲线上显示出实质性的“超弹性平台(superelastic plateau)”或“标志区域”。作为替代，对于线性弹性和/或非超弹性镍钛诺而言，随着可恢复应变增加，应力大体上呈线性或在一定程度上但未必完全是线性关系增加直至发生弹性形变，或增长关系至少比超弹性镍钛诺所显示的超弹性平台和/或标志区域更为线性。因此，在本公开的意义上线性弹性和/或非超弹性镍钛诺也可定义为“大体”线性弹性和/或非超弹性镍钛诺。
在某些情况下，线性弹性和/或非超弹性镍钛诺与超弹性镍钛诺的区别还可在于线性弹性和/或非超弹性镍钛诺在受到约2-5％的应力时仍可保持基本弹性(如在塑性变形之前)，而超弹性镍钛诺在塑性变形之前可受到8％的应力。两种材料可与其他线性弹性材料如不锈钢(其还可根据成分的不同予以区别)区别开来，不锈钢在塑形变形之前仅可受到约0.2-0.44％的应变。
在某些实施例中，线性弹性和/或非超弹性镍钛合金是在一个大的温度范围上不显示通过差示扫描量热法(DSC)和动态金属热分析(DMTA)的分析可检测的任何马氏体/奥氏体相变的合金。例如，在某些实施例中，在约-60摄氏度(℃)-约120摄氏度(℃)的范围内在线性弹性和/或非超弹性镍钛合金中可检测不出马氏体/奥氏体相变。因此这些材料的机械弯曲性能在该较大的温度范围内对温度的影响是大致为惰性的。在某些实施例中，线性弹性和/或非超弹性镍钛合金在环境温度或室温下的机械弯曲性能与在体温下的机械性能大致相同，例如，它们均不显示超弹性平台和/或标志区域。换句话说，线性弹性和/或非超弹性镍钛合金在较大的温度范围内保持其线性弹性和/或非超弹性特性和/或性能。
在某些实施例中，线性弹性和/或非超弹性镍钛合金可含有约50-60重量百分比的镍，其它的基本上是钛。在某些实施例中，其成分是约54-57重量百分比的镍。适当的镍钛合金的示范例是从日本神奈川县古河化工技术材料有限公司商业可得的FHP-NT合金。镍钛合金的一些示范例公开在美国第5,238,004和6,508,803号专利中，其通过引用被并入在此。其他适当的材料可包括ULTANIUMTM(可从Neo-Metrics购得)和GUM METALTM(可从Toyota购得)。在某些其他实施例中，超弹性合金，例如超弹性镍钛诺可用于达到所需性能。
在至少某些实施例中，消融器械120的部分也可由不透射线材料制成、掺入或以其他方式包含不透射线材料。不透射线材料被理解为能够在医疗程序过程中在透视屏或其它成像技术上产生相对亮的图像的材料。该相对亮的图像帮助消融器械120的使用者确定其位置。不透射线材料的某些示范例可包括，但不限于，金、铂、钯、钽、钨合金、装载有不透射线填充的聚合物材料等。此外，其他不透射线的标记带和/或线圈也可以被结合到消融器械120的设计，以达到相同的结果。
在某些实施例中，一定程度的磁共振成像(MRI)相容性被施加到消融器械120。例如，装置的部分可由不实质性扭曲图像且产生实质伪影(即图像中的间隙)的材料制成。例如特定的铁磁性材料可能不适合，因为其在MRI成像中产生伪影。在某些这些实施例或其他实施例中，消融器械120的部分也可由MRI仪器可以成像的材料制成。显示出此种特性的某些材料包括例如钨、钴铬钼合金(例如，如等UNS：R30003)、镍钴铬钼合金(例如，如等UNS：R30035)、镍钛诺等及其他材料。
2013年1月25日提交的序列号为13/750879的美国专利申请，现在为美国专利公开号US20130165926A1通过引用并入本文。
应当理解的是，本发明在许多方面仅仅是说明性的。在不超出本发明范围的前提下，可以在细节上进行变化，尤其是在形状、尺寸和步骤的安排方面进行变化。这可以包括，在适当的范围内，在其他实施例中可以使用一个示例性实施例中的任何特征。本发明的保护范围，当然，用所附权利要求书表述的语言进行了界定。

Claims (15)

1.一种用于组织消融的医疗器械，包括：
导管轴；
被设置在所述导管轴上的可扩张球囊，所述球囊能够在未扩张形态和扩张形态之间转换；以及
多个细长的电极组件，每个所述电极组件均被构造为柔性电路，所述多个电极组件中的每一个都包括以至少第一和第二间隔开的阵列进行布置的多个电极，所述多个电极组件被设置在所述球囊的外表面上并且限定预定折叠线，所述可扩张球囊能够在缩放后沿所述预定折叠线进行折叠；
其中所述多个电极组件中的每一个包括与阵列中的两个以上的电极对齐的一个以上的温度传感器。
2.根据权利要求1所述的医疗器械，其中所述第一阵列包括多个有源电极而所述第二阵列包括多个接地电极。
3.根据权利要求1所述的医疗器械，其中每个温度传感器位于电极下。
4.根据权利要求1所述的医疗器械，其中每个温度传感器位于阵列内的两个电极之间。
5.根据权利要求2所述的医疗器械，其中所述接地电极被设置在接地迹线上，其中所述一个以上的温度传感器共用所述接地迹线。
6.根据权利要求4所述的医疗器械，其中所述多个细长电极组件中的每一个由一个以上的层压聚合物/铜片制成，其中所述接地电极形成于聚合物层中的凹部中，且所述一个以上的温度传感器被设置在两个接地电极之间的凹部中。
7.根据权利要求6所述的医疗器械，其中所述一个以上的层压聚合物/铜片包括两个层压片材，其中每个片材包括被层压至铜层的聚合物层，其中所述片材是按第一片材的铜层被附接至第二片材的聚合物层的方式进行布置的，其中所述接地电极形成于所述第一片材的所述聚合物层中，且所述一个以上的温度传感器被附接至所述第二片材的所述铜层，其中过孔将所述第一和第二片材的所述铜层连接起来。
8.根据权利要求1所述的医疗器械，其中所述一个以上的温度传感器被设置在所述多个电极组件中的每一个的底侧，且所述底侧被附接至所述球囊的所述外表面。
9.根据权利要求1-8中任一项所述的医疗器械，其中所述多个电极组件适于用所述球囊进行展开和折叠。
10.根据权利要求9所述的医疗器械，其中所述球囊是非顺应性球囊。
11.根据权利要求1所述的医疗器械，其中所述多个细长电极组件包括在所述多个电极下且在其之间延伸的基层，其中移除了在所述第一和第二阵列之间的所述基层的一部分。
12.根据权利要求1所述的医疗器械，其中所述一个以上的温度传感器为热敏电阻。
13.根据权利要求1所述的医疗器械，其中在所述第一和第二阵列中的所述电极是线性对齐的。
14.根据权利要求2所述的医疗器械，其中每个温度传感器被设置在每个电极组件上的最近侧接地电极的近侧。
15.根据权利要求1所述的医疗器械，其中每个温度传感器为溅射热电偶。
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