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CN105377170A - 具有可伸展电极组件的医疗装置 - Google Patents

具有可伸展电极组件的医疗装置 Download PDF

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CN105377170A
CN105377170A CN201480039636.5A CN201480039636A CN105377170A CN 105377170 A CN105377170 A CN 105377170A CN 201480039636 A CN201480039636 A CN 201480039636A CN 105377170 A CN105377170 A CN 105377170A
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德里克·C·苏特米斯特
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
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Abstract

公开了医疗装置，以及制造和使用医疗装置的方法。一个医疗装置的目的可以包括导管轴。可扩张球囊可以连接到所述导管轴，所述可扩张球囊能够在缩小形态和膨胀形态之间变化。具有电通路的电极组件可以连接到球囊。所述电通路能够在蛇形的形态和更直的形态之间变化，所述球囊处在所述收缩形态时为蛇形的形态，所述球囊处在所述膨胀形态时为更直的形态。

Description

具有可伸展电极组件的医疗装置
交叉引用
本申请根据35U.S.C.§119，要求序号为61/845,291，于2013年7月11日提出的美国临时申请的优先权，其全部通过引用并入到本文中。
技术领域
本发明涉及医疗装置，以及制造医疗装置的方法。更具体的，本发明涉及肾神经消融的医疗装置。
背景技术
为了医疗使用的目的，例如，为了血管内使用的目的，已经开发了各种体内医疗装置。这些装置中的一些包括了导丝、导管等。这些装置可以通过各种不同的制造方法进行制造，并且可以根据各种方法来使用。在已知的医疗装置和方法中，每一种都具有某些优点和缺点。有提供可替代医疗装置，以及制造和使用医疗装置可替代方法的不断的需要。
发明内容
本发明提供了医疗装置的可替代的设计、材料、制造方法以及使用方法。作为例子的医疗装置包括了肾神经消融的医疗装置。该医疗装置可以包括导管轴，连接到所述导管轴的可扩张件，所述可扩张件包括近端区域、远端区域，和在两者之间延伸的本体，所述可扩张件能够在未扩张形态和扩张形态之间移动，以及固定连接到所述可扩张件本体的多个电极组件，所述多个电极组件，每个包括可伸展的电通路，所述电通路能够随着可扩张件扩展。
在一些实施例中，当所述可扩张件处在非扩张形态时，所述可伸展的电通路以非直线的形态布置。所述非直线形态可以是蛇形(serpentine，弯曲)或者正弦形态。当所述可扩张件处在扩张形态时，所述可伸展电通路可以扩展，并且朝着更直的形态移动。
在一些实施例中，一种肾神经消融的医疗装置，包括导管轴，连接到所述导管轴的可扩张球囊，所述可扩张球囊能够在缩小形态和膨胀形态之间变化，以及固定连接到所述可扩张球囊的多个电极组件，所述多个电极组件包括多条可伸展的电通路，当所述可扩张球囊变换到所述膨胀形态时，所述电通路能够伸展，其中所述可伸展电通路能够在非线性的形态和更直的形态之间变化，所述可扩张球囊处在所述收缩形态时为所述非直线的形态，所述可扩张球囊处在所述膨胀形态时为所述更直的形态。
在一些实施例中，消融肾神经的方法包括提供一种医疗装置，所述医疗装置包括导管轴，连接到所述导管轴的可扩张球囊，所述可扩张球囊能够在缩小形态和膨胀形态之间变化，以及固定连接到所述可扩张球囊的多个电极组件，所述多个电极组件包括多条可伸展的电通路，当所述可扩张球囊变换到所述膨胀形态时，所述电通路能够伸展，其中所述可伸展电通路能够在非直线的形态和更直的形态之间变化，所述可扩张球囊处在所述收缩形态时为所述非直线的形态，所述可扩张球囊处在所述膨胀形态时为所述更直的形态。所述方法可以进一步包括使医疗装置前进穿过血管到达肾动脉内的位置，使可扩张球囊膨胀，其中使得所述可扩张球囊膨胀使得可伸展电通路从非直线形态朝着更直的形态变化，激活至少一些电极组件，以及缩小球囊，其中缩小球囊使得可伸缩电通路朝着非直线形态变化。
上文一些实施例的内容不打算对本发明的每个公开的实施例或者每个实施方式进行描述。其后的附图以及详细的说明尤其特别地例证了这些实施例。
附图说明
结合附图和下文详细的说明可以更加完整地理解本发明，其中：
图1为示例肾神经消融系统的示意图；
图2为示例性的处在扩张形态的医疗装置的部分的示意侧视图；
图3为处在未扩张形态的图2医疗装置的示意侧视图；以及
图4为示例电极组件的示意图。
尽管本发明有各种改造和替代形式，但是它们的特征已经通过附图中例子的形式进行了示出，并且将详细的进行描述。然而应该理解，没有要将本发明限制于特定的所描述的实施例的目的。相反，要覆盖所有落入本发明精神和范围内的改造、等同以及替代的方案。
具体实施方式
下面的说明应该参考附图进行阅读，这些附图未必按比例进行绘制，其中几幅图中类似的元件采用相同的编号表示。这些详细的说明和附图出于说明的目的，并不打算对要求权利的发明进行限制。本领域的技术人员应认识到，所描述和/或示出的各种元件，可以在不超出本发明保护范围的前提下，以各种组合和形态进行布置。详细的说明和附图示出的是所要求权利的发明的示例性的实施例。
对于下面所定义的术语，将使用这些定义，除非在权利要求或者说明书的其他地方给出了不同的定义。
文中所有的数值假设都由术语“大约”进行了修饰，除非有明确的说明。与数值有关的术语“大约”，通常指本领域技术人员会考虑的，与所描述值等同的数值的范围(例如，具有相同的功能或结果)。在许多例子中，术语“大约”可以包括对最近的有效数字取整后所得的数字。术语“大约”的其他使用(例如，文中的而不是数值的)可以假设具有其本义以及习惯定义，正如从说明书的内容所理解并且与其一致的，除非另有说明。
由端点进行描述的数值范围包括了范围内的所有数，包括端点(例如1到5包括1、1.5、2、2.75、3、3.80、4和5)。
正如说明书和所附权利要求书中所使用的，但数形式“a”、“an”和“the”包括了对复数形式的引用，除非文中另有清楚的说明。正如说明书和所附权利要求书中所使用的，术语“or”通常使用其“和/或”的本义，除非文中另有清楚的说明。
注意到，说明书中“一个实施例”、“一些实施例”、“其他实施例”等的引用表明，所描述的这些实施例包括了特定的特征、结构或者特性，但每个实施例未必都包括该特定的特征、结构或者特性。此外，这些短语未必指相同的实施例。进一步地，当特定的特征、结构或者特性在有关的实施例进行了描述，使得这些特征、结构或者特性在其他有关的实施例中有效实施，属于本领域技术人员的知识范畴，无论是否明确描述，除非有相反的清楚表述。也就是说，下文所描述的各种单独的构件，即使未以特定的组合形式进行明确的表示，根据本领域的技术人员的理解，也应想到彼此是可结合或者可布置的，以形成另外其他的实施例，或者对所描述的实施例进行补充和丰富。
某些治疗针对选择神经功能暂时或者永久阻断或者改造。这些治疗的一个例子为肾神经消融，所述肾神经消融有时用来治疗例如或者有关于高血压、充血性心力衰竭、糖尿病的病况，或者其他受到高血压或者盐潴留影响的情况。肾脏发生交感神经响应，该交感神经响应可能增加水和/或钠不想要的滞留。交感神经响应的结果，例如，可能在血液中增加。对通向肾脏的神经(例如，紧邻或者另外沿肾动脉进行布置)中的一些进行消融，可以减少或消除该交感神经响应，交感神经响应的减少对应了所关联的不希望的症状的减少(例如，血压的降低)。
本发明的一些实施例涉及生成能量并且控制的装置，该装置经常用于目标组织的治疗以达到实现疗效的目的。在一些实施例中，所述目标组织为包含或者近似于神经的目标组织，包括肾动脉以及关联的肾神经。在其他的实施例中，所述目标组织为腔组织，其可以进一步包括例如在动脉疾病中所发现的病变组织。
在本发明的一些实施例中，为了实现有益的生物反应，以靶向剂量传送能量的能力可以用于神经组织。已知例如，慢性疼痛、泌尿功能障碍、高血压以及各种其他持续性情况，将在神经组织的手术过程中产生影响。例如，已知可能对药物无反应的慢性高血压，可以通过使邻近肾动脉的过度神经活动失效，得到改进或消除。也已知神经组织不天生具有再生特性。因此，可以通过阻断神经组织的传导路径来有益地影响过度的神经活动。当阻断神经的传导路径时，对于避免对相邻的神经或器官组织造成破坏特别具有优势。引导和控制能量剂量的能力非常适合于神经组织的治疗。无论是加热还是消融能量剂量，可以将本文所描述和公开的能量传送的精确控制引导到神经组织。此外，能量的引导应用对于定位神经已经足够，而不需要如使用一般的消融探针时所要求的精确接触。例如，可以以高的足以使神经组织变性的温度进行偏心加热，不会产生消融，也不要求刺穿腔组织。然而，本发明也希望配置能量传送表面来刺穿组织，并且用精确的能量剂量像消融探针那样传送消融能量，所述能量剂量由能量控制和生成装置进行控制。
电能损耗取决于电极阻抗或者电极-组织接口的阻抗，而不是有源电极和接地电极之间组织阻抗的损耗。需要说明的，鉴于一般的RF消融治疗可以使用具有导电电极的医疗装置，所公开的概念可以包括具有一个以上电阻电极的电阻柔性电极组件、覆盖在导电电极上的电阻材料、微加热器和/或其他电阻。电阻柔性电极组件的使用，可以考虑低电压消融装置，在这些装置中，电能可以通过直流电或者交流电的方式提供(例如，低压直流电、低频(小于200KHz)交流电或者其他能量)。
在一些实施例中，失神经治疗的疗效能够通过治疗前、治疗中和/或治疗后的测量进行评估，该测量用来提取特定病人治疗的一个以上的参数，或者用来判断另外治疗的需要。例如，失神经治疗系统可以包括评估功能，用来对治疗是否已经开始，或者是否正在目标组织或邻近组织引起神经活动的降低进行评估，该功能可以提供调整治疗参数的反馈，或者表明另外治疗的必要性。
尽管本文所讨论的是关于肾神经消融和/或改造的装置和方法，可以想到，该装置和方法可以用于其他位置和/或应用的治疗中，在这些位置和/或应用中，例如但不限于：血管、尿管或者在其他组织中，需要通过套管针和插管进入的方式，进行神经改造和/或其他组织改造，所述改造包括加热、激活、阻断、干扰或者消融。例如，本文所描述的装置和方法能够应用于增生组织消融、心脏消融、肺静脉隔离、肺静脉消融、肿瘤消融、良性前列腺增生治疗、神经激活或者阻断或者消融、肌肉活动的改造、组织的热疗或者其他增温方式、淋巴管或者淋巴结内的消融等。
图1为示例肾神经消融系统100的示意图。系统100可以包括肾神经消融装置120。肾神经消融装置120可以用来消融位于近邻肾脏K位置(例如，位于肾动脉RA周围的肾神经)的神经(例如，肾神经)。使用中，可以使肾神经消融装置120前进穿过例如主动脉的血管到达肾动脉RA内的位置。这可以包括使肾神经消融装置120穿过引导护套或者导管14。当如期望地定位时，可以激活肾神经消融装置120来激活一个以上的电极(未示出)。这可以包括将肾神经消融装置120可操作地连接到控制单元110，以便给电极提供需要的激活能量，所述控制单元可以包括RF生成器。例如，肾神经消融装置120可以包括带有连接器20的导线或者导电元件18，所述连接器20能够连接到控制单元110上的连接器22，和/或连接到控制单元110的导线24。在至少一些实施例中，控制单元110也可以用来供应/接收合适的电能和/或信号以激活一个以上的传感器，这些传感器布置在肾神经消融装置120的远端，或者在其远端附近。当被合适地激活时，电极能够如下文所述地消融组织(例如，肾神经)，并且传感器可以用来检测所需要的物理和/或生物参数。
在一些实施例中，肾神经消融装置120可以包括细长的管形件或者导管轴122。在一些实施例中，可以配置所述细长的管形件或者导管轴122在导丝或者其他细长的医疗装置上滑动前进，到达目标位置。在一些实施例中，可以配置所述细长的管形件或者导管轴122在引导护套或者导管14内滑动前进，到达目标位置。在一些实施例中，可以配置所述细长的管形件或者导管轴122在导丝上，在引导护套或者导管14内，或者以它们结合的方式前进，到达目标位置。如图2中所示，可扩张件130可以布置在细长管形件或者导管轴122的远端区域，或者布置在其上，布置在其周围，布置在其附近。
在一些实施例中，如图2中所示，一个以上的电极组件140可以布置在可扩张件130上，图中所示的可扩张件130处在扩张状态。电极组件140可以构造成连接到可扩张件130的柔性基片，该基片上布置有一个以上的电极145。在至少一些实施例中，电极组件140可以配置成随着或能够随着可扩张件130扩张。例如，在一些实施例中，电极组件140可以是电极和/或导电通路，所述导电通路可直接印刷在可扩张件130上。在其他的实施例中，电极组件140可以包括连接到可扩张件130的基片。当采用基片时，所述基片可以用例如聚酰亚胺的聚合物进行制造，尽管包括本文所公开的那些材料的其他材料也可以考虑。
每个电极组件140可以包括一条以上分离的电通路150，每条电通路150自电极145上的电触头155穿过可扩张件130连通。这些电通路150可以包括接地通路和有源通路。在一些实施例中，可以使用多条有源通路来给指定的电极145供电。每条有源通路可以供应用来给电极145供电的部分的能量。例如，如果将指定的电极145设计成传输1W的电能，可以将每条供应0.5W电能的两条电通路150连接到电极145。类似地，如果需要1.5W的电能，可以使用三条电通路(每条传输0.5W的电能)。应理解电能的配送可以改变，使得电极145处能够具有需要的治疗能量。此外，也可以使用更多或更少的电通路来配送需要的电能。
在至少一些实施例中，由每个电极145传送的总电能，与由每条电通路150提供的电能的总量基本上相等。因为这一点，每条电通路150所传送的电能可以减少。如果需要电能进一步地减少，可以使用另外的电通路150。这种安排允许在仍然能够使用低电能电通路150的同时，电极145处的总电能增加。因为这一点，控制单元112仅需要供应相对少量的电能。这也允许电源使用直流电作为电源(尽管也可以考虑交流电)。
电极组件140可以以各种形态布置在可扩张件130上。如图2-3中所示，在一些实施例中，电极组件140偏置。在其他的实施例中，电极组件140可以沿可扩张件130的纵轴线直线地布置，沿对角线对齐，或者具有沿可扩张件130长度的螺旋定向。在一些实施例中，电极组件140的螺旋定向，在可扩张件130定位的腔或血管内形成至少一个完整的(360度)的圆周回路。为了阻断位于围绕身体通道壁的组织中的神经，电极组件140可以在围绕身体通道的组织内的位置进行加热，而不破坏身体通道壁。需要螺旋定向来帮助避免狭窄风险的增加，当电极布置在与身体通道的纵轴线正交的单平面内时，该风险可能出现(例如，圆电极或电极组)。
在一些实施例中，至少一个温度传感器160布置在一个以上的电极组件140上。温度传感器160具有电通路150，所述电通路150自传感器160起延伸，并且穿过可扩张件130。在一些实施例中，温度传感器160可以是热电偶或者热敏电阻。为了帮助减少总厚度，温度传感器160可以布置在基片中的开口内。温度传感器160可以在电极组件140的非组织接触侧。因此，当纳入到最终装置(例如，消融装置120)时，温度传感器160可以固定在电极组件140和可扩张件130之间。这是具有有益效果的，因为表面-安装的电元件，例如热敏电阻，通常具有锋利的边和角，这可能勾住组织并且可能引起球囊展开和/或收缩的问题。
在一些实施例中，可扩张件130是球囊。在一些实施例中，该球囊是可扩张球囊。当使用可扩张球囊时，当球囊扩张时，拉伸力和/或其他的力可能作用在电极组件140(例如，电通路15)上。不希望这些力影响电通路150。因此，设计电极组件140和电通路150，使得当可扩张球囊膨胀时，它们能够伸展或者用另外的方法扩张。在一些实施例中，电通路150可以直接布置在可扩张球囊130的壁上，或者形成在其中。在一些实施例中，电通路150可以印刷在可扩张球囊130上。如图4中所示，电通路150可以以蛇形(serpentine，弯曲)或者正弦的形态布置在球囊130上。当可扩张球囊130扩张时，蛇形的通路150能够伸直。未扩张球囊130上的通路150蛇形的形态，在通路长度上提供了过量的长度或者松弛的状态，使得球囊扩张不会破坏通路150或者过度扭曲通路150。蛇形波的高度和/或间隔可以基于球囊扩张度进行调整。如图2中所示，当可扩张球囊130处在扩张形态时，通路150可以朝着更加直的形态移动，减少蛇形波的高度，使得通路150变得更直。在一些实施例中，电通路150可以在制造过程中纳入到可扩张球囊130的壁中。在一些实施例中，电通路150可以直接印刷在球囊130的表面上。在一些实施例中，电通路150和电极组件140可以连接到可扩张球囊130的表面，例如通过使用粘合剂。
如图4中所示，电极组件140可以包括多个电极。在一些实施例中，电极组件包括至少两个电极145。每个电极145可以包括至少两个电触头155。每个电触头155可以连接到蛇形的电通路150。可以以组的形式布置电触头155以形成电路，电能穿过该电路进行传送。在一些实施例中，六个电触头，三个一组进行布置以形成电路。在一些实施例中，每个电极组件140具有圆形的转角，以减少在其他装置和/或组织上划破的可能性。与它们关联的电极组件140和通路150可以以双极或单极模式起作用。在一些实施例中，当与组织面对面放置时，电极组件140可以传送至少一瓦来进行去神经支配治疗。如图4中所示，在一些实施例中，六个电触头155以三个电极145一组进行布置，能量经电极组件140进行传送。每个电触头155可以传送约0.5瓦的能量。多条电通路150考虑到了更加大的总电能传送。多个电极可以彼此紧靠布置，并且可以在尺寸上变化以实现需要的电能传送。在一些实施例中，多个电极145可以直接连接到可扩张件130，或者印刷在其上，而不需要基片。电极组件140或各个电极145可以布置在可扩张件130的表面上，以提供需要的治疗模式。在一些实施例中，当拉伸、扣住、扭曲、弯曲或者用另外的方法操纵可扩张件130时，可以选择布置电极组件140和/或各个电极145以及它们关联的电通路150来实现需要的形态。
在一些实施例中，肾神经消融装置120可以包括双极电极对。当给肾神经消融装置120供应能量时，RF能量或者其他合适的能量可以从有源电极，穿过血管壁和目标组织(例如，肾神经)，到达接地电极，因此造成对应的损毁或者沿可扩张件130处于其中的身体通道的损毁。温度传感器160可以定位在接地电极和有源电极之间。温度传感器160可以定位在接地电极和有源电极之间，并且可以配置其监测目标组织、有源和接地电极或者两者的温度。在一些实施例中，在沿可扩张件130长度的多个位置，配置多个温度传感器来监测目标组织、有源电极、接地电极或者它们任意组合的温度。
系统100可以用来实施按照本发明一个非限制实施例的治疗方法。例如，控制单元110可以可操作地连接到消融装置120，所述消融装置120可以插入到身体通道，使得可扩张件130(具有多个电极组件)可以邻近身体通道的需要治疗的第一部分放置。消融装置120在需要治疗的身体通道的第一部分的放置，可以根据现有的方法实施，例如，在透视引导下顺着导丝放置。一旦插入，可以使得可扩张件130从塌缩传送形态扩张到扩张形态，例如在球囊的情况下，加压2-10atm的流体。这可以使得可扩张件130的电极和/或电极组件接触到身体通道的第一部分。
在一些实施例中，消融装置120可以穿过血管前进到达邻近目标组织(例如，肾动脉内)的位置。在一些实施例中，目标组织可以是围绕肾动脉布置的一条以上的肾神经。当合适定位时，可扩张件130可以从塌缩传送形态扩张到扩张形态。这可以贴着血管壁放置有源电极。可以激活电极145。消融能量可以从电极145传递穿过目标组织(在此处肾神经可以被消融、改造或者用另外的方法影响)。
能够用于消融装置120各种元件的材料(和/或本文所公开的其他装置)，可以包括那些通常与医疗装置关联的材料。为了简化的目的，下面的讨论引用消融装置120。然而，这不打算限制本文所描述的装置和方法，因为讨论可以应用到本文所公开的其他类似的管形件和/或可扩张件，和/或管形件和/或可扩张件的元件。
消融装置120和其各种元件可由金属、金属合金、聚合物(其中的一些例子将在下文公开)、金属-聚合物复合材料，陶瓷、它们的结合，以及类似的，或者其他合适的材料。合适聚合物的一些例子可以包括聚四氟乙烯(PTFE)、乙烯-四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚甲醛(POM，例如，可从DuPont获得的)、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，可从DSM工程塑料购得的)、醚或基于酯共聚物(例如，丁烯/聚(亚烷基醚)邻苯二甲酸酯和/或其他的聚酯弹性体，如可从杜邦购得的)、聚酰胺(例如，可从Bayer购得的或可从ElfAtochem购得的)、弹性体聚酰胺、嵌段聚酰胺/醚、聚醚嵌段酰胺(PEBA，例如商品名为的)、乙烯醋酸乙烯酯共聚物(EVA)、硅树脂、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、聚对苯二甲酸丁酯(PBT)、聚对苯二甲酸乙酯(PET)、聚三亚对苯二甲酸酯、聚萘(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(例如，可从EMSAmericanGrilon购得的)、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-￡-异丁烯-￡苯乙烯)(例如，SIBS和/或SIBS50A)、聚碳酸酯、离聚物、生物相容的聚合物，其他合适的材料，或它们的混合物、组合物、共聚物、聚合物/金属复合物，和类似物。在一些实施例中，护套能够混纺液晶聚合物(LCP)。例如，该混合物能够包含至多约6％的LCP。
合适的金属和金属合金的一些例子可以包括不锈钢，例如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；其他镍合金如镍-铬-钼合金(例如，UNS：N06625如UNS：N06022如UNS：N10276如其他合金，以及类似的)，镍-铜合金(例如，UNS：N04400如400，以及类似的)，镍-钴-铬钼合金(如，UNS：R30035如等)，镍-钼合金(如，UNS：N10665如合金)，其他镍-铬合金，其他镍-钼合金，其他镍-钴合金，其他镍-铁合金，其他镍-铜合金，其他镍-钨或钨合金等；钴铬合金；钴-铬-钼合金(如，UNS：R30003如 等)；铂富集不锈钢；钛；它们的组合；以及类似的；或者任何其他合适的材料。
正如本文所提及的，在商业可获得的镍-钛或镍钛诺合金家族中，有指定为“线弹性”或“非超弹性”的类别，尽管该类别在化学上与现有的形状记忆和超弹性品种类似，但是其可以展示不同而有哟个的机械属性。线弹性和/或非超弹性镍钛诺区别于超弹性镍钛诺，不像超弹性镍钛诺，线弹性和/或非超弹性镍钛诺不在应力/应变曲线上显示实质的“超弹性平台”或者“旗形区域”。取而代之的，在线弹性和/或非超弹性镍钛诺中，当可恢复应变增加时，应力继续以基本上线性，或者有点线性但未必完全线性的关系继续增加，直到弹性变形开始，或者至少以用超弹性镍钛诺可看出超弹性平台和/或旗形区域的更加线性的关系。因此，为了公开的目的，线弹性和/或非超弹性镍钛诺也可以命名为“基本上”线弹性和/或非超弹性镍钛诺。
在一些情况中，线弹性和/或非超弹性镍钛诺与超弹性镍钛诺也可以区别于，线弹性和/或非超弹性镍钛诺可以承受至多大约2-5％的应变，而基本上任然具有弹性(例如，在弹性变形前)，然而超弹性镍钛诺在弹性变形前可以承受至多大约8％的应变。这两种材料都能区别于其他线弹性材料，例如不锈钢(也能够基于其成分进行区别)，不锈钢在弹性变形前仅可以承受大约0.2％到0.44％的应变。
在一些实施例中，线弹性和/或非超弹性镍钛合金是不显示任何马氏体相/奥氏体相变化的合金，所述变化可以在大的温度范围过程内，通过差示扫描量热法(DSC)和动态金属热分析(DMTA)进行分析检测。例如，在一些实施例中，在线弹性和/或非超弹性镍钛合金中，在大约-60摄氏度(℃)到大约120℃的范围内，没有可通过DSC和DMTA分析可以检测到的马氏体相/奥氏体相。因此，这些材料的机械弯曲属性，在这个非常宽的温度范围内，通常对温度的效应具有惰性。在一些实施例中，线弹性和/或非超弹性镍钛合金环境温度或室内温度的机械弯曲属性与身体温度的机械属性基本上相同，例如，其中它们不显示超弹性平台和/或旗形区域。换句话说，在一个非常宽的温度范围内，线弹性和/或非超弹性镍钛合金维持其线弹性和/或非超弹性特征和/或属性。
在一些实施例中，线弹性和/或非超弹性镍钛合金可以大约50％到60％的重量百分比为镍，而剩下的基本上为钛。在一些实施例中，成分中大约54％到大约57％的重量百分比为镍。合适的镍钛合金的一个例子为FHP-NT合金，可从日本神奈川的FurukawaTechnoMaterialCo.购得。U.S.PatentNos.5,238,004和6,508,803中公开了镍钛合金的一些例子，通过引用将它们并入到本文中。其他合适的材料可以包括ULTANIUMTM(可从Neo-Metrics获得)和GUMMETALTM(可从Toyota获得)。在一些其他的实施例中，超弹性合金，例如超弹性镍钛诺能够用来实现需要的属性。
在至少一些实施例中，消融装置120的部分也可以掺杂不透射线材料，或者由其制成或者用别的方法包含其。可以将不透射线材料理解成，能够在医疗手术过程中在荧光屏上产生相对亮的图像或者另一种成像技术的材料。该相对亮的图像协助消融装置120的使用者确定其位置。不透射线材料的一些例子能够包括，但不限于金、铂、钯、钽、钨合金、装载有不透射线填充材料的聚合物，以及类似物。另外，其他不透射线标记带和/或圈也可以并入到消融装置120的设计中，以实现相同的结果。
在一些实施例中，消融装置120被赋予了一定程度的磁共振成像(MRI)兼容性。例如，部分的装置，可以由基本上不使图像失真并且不产生实质伪影(例如，图像中的间隙)的材料制成。例如，某些铁磁材料可能不适合，因为它们在MRI图像中可能产生伪影。在一些或者其他的实施例中，部分的消融装置120也可以由MRI机器能够成像的材料制成。一些展示了这些特征的材料包括，例如，钨、钴-铬-钼合金(例如，UNS：R30003如等)，镍-钴-铬-钼合金(例如，UNS：R30035如等)，镍钛诺，和类似物，以及其它。
美国专利申请序号为13/750,879，美国专利申请公布号为US2013/0165926，于2013年1月25日提出的，名称为“重构身体通道的组织或者重构与身体通道相邻的组织的方法和装置”的专利文件通过引用并入到本文中。
应该理解，本发明在许多方面仅仅是说明。在不超出本发明保护范围的前提下，可以在细节上进行变化，尤其在形状、尺寸和步骤安排方面。这可以包括，在一定程度应意识到，一个实施例所使用的所有特征可以用在其他实施例中。本发明的保护范围，当然，用所附权利要求书所表达的语言进行界定。

Claims (15)

1.一种肾神经消融用医疗装置，包括：
导管轴；
连接到所述导管轴的可扩张件，所述可扩张件包括近端区域、远端区域和在两者之间延伸的本体，所述可扩张件能够在未扩张形态和扩张形态之间移动；以及
固定附接至所述可扩张件本体的多个电极组件，所述多个电极组件每个包括可伸展的电通路，所述电通路能够随着所述可扩张件扩展。
2.如权利要求1所述的医疗装置，其中所述可扩张件为球囊。
3.如权利要求2所述的医疗装置，其中所述球囊为可扩张球囊。
4.如权利要求1-3中任意一个所述的医疗装置，其中所述电极组件中的每一个包括至少两个电极。
5.如权利要求1-4中任意一个所述的医疗装置，其中当所述可扩张件处在非扩张形态时，所述可伸展的电通路以非直线的形态布置。
6.如权利要求5任意一个所述的医疗装置，其中所述非直线的形态包括蛇形或者正弦形态。
7.如权利要求1-6中任意一个所述的医疗装置，其中当所述可扩张件处在扩张形态时，所述可伸展电通路扩展，并且朝着更直的形态移动。
8.如权利要求1-7中任意一个所述的医疗装置，其中所述电极组件印刷在所述可扩张件上。
9.如权利要求1-8中任意一个所述的医疗装置，其中所述电极组件中的至少一些包括一对相邻的双极电极。
10.如权利要求1-9中任意一个所述的医疗装置，其中所述电极组件中的至少一些包括单极电极。
11.如权利要求1-10中任意一个所述的医疗装置，进一步包括布置在所述多个电极组件中的一个以上电极组件上的温度传感器。
12.如权利要求1-11中任意一个所述的医疗装置，其中所述多个电极组件围绕所述可扩张件的本体螺旋布置。
13.一种肾神经消融的医疗装置，包括：
导管轴；
连接到所述导管轴的可扩张球囊，所述可扩张球囊能够在缩小形态和膨胀形态之间变化；以及
固定附接至所述可扩张球囊的多个电极组件，所述多个电极组件包括多条可伸展的电通路，当所述可扩张球囊变换到所述膨胀形态时，所述电通路能够伸展，其中所述可伸展电通路能够在非直线的形态和更直的形态之间变化，所述可扩张球囊处在所述收缩形态时为所述非直线的形态，所述可扩张球囊处在所述膨胀形态时为所述更直的形态。
14.如权利要求13所述的医疗装置，其中当处在所述非直线的形态时，所述可伸展电通路具有蛇形或者正弦的定向。
15.如权利要求13-14中任意一个所述的医疗装置，进一步包括至少一个布置在所述可扩张球囊上的温度传感器。
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