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CN105636537B - 医疗器械球囊 - Google Patents

医疗器械球囊 Download PDF

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CN105636537B
CN105636537B CN201480057006.0A CN201480057006A CN105636537B CN 105636537 B CN105636537 B CN 105636537B CN 201480057006 A CN201480057006 A CN 201480057006A CN 105636537 B CN105636537 B CN 105636537B
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CN105636537A (zh
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杰弗瑞·S·林德奎斯特
卡斯·A·汉森
帕特里克·A·哈夫科斯特
丹尼尔·J·霍恩
马丁·R·威拉德
德里克·C·苏特米斯特
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Boston Scientific Scimed Inc
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Abstract

本发明公开了医疗器械及其制造和使用方法。一种实例医疗器械可包括导管轴。可扩张构件可被联接至所述导管轴。所述可扩张构件可以在折叠形态和扩张形态之间转换。多个柔性元件可被附接至所述可扩张构件，在所述柔性元件上设有多个电极组件。所述柔性元件可具有沟槽基板。

Description

医疗器械球囊
相关申请的交叉引用
本申请根据35U.S.C.§119要求于2013年10月15日提交的序列号为61/891,257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，本发明关于用于交感神经消融的医疗器械。
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
本发明提供了用于医疗器械的设计、材料、制造方法和用途的替代方案。一种实例医疗器械包括用于交感神经调制和/或消融的医疗器械。医疗器械可包括导管轴；被联接至导管轴的可扩张构件，该可扩张构件具有纵轴线、近侧区域、远侧区域以及在其之间延伸的本体；以及多个被附接至可扩张构件的本体的柔性元件，柔性元件包括多个电极组件，其中柔性元件包括具有多个在其中形成的细长沟槽的基板。
另一种实例医疗器械可包括导管轴；具有纵轴线、远侧腰部、近侧腰部以及在其之间延伸的本体，近侧腰部被联接至导管轴；被附接至可扩张球囊的柔性基板，基板包括多个在其中形成的沟槽；以及多个被设置在柔性基板上的电极组件。
一种制造医疗器械的实例方法可包括在基板中形成多个沟槽，在沟槽基板上形成电路，将沟槽基板固定至可扩张球囊上并将可扩张球囊附接至导管。
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
结合附图考虑下面具体实施方式可更完全地理解本发明，其中：
图1为实例交感神经消融器械的示意图；
图2为交感神经消融器械的实例可扩张构件的立体图；
图3为图2所示的可扩张构件在展开或平坦形态中的局部俯视图；
图4A为实例电极组件的一部分的俯视图；
图4B-4H为实例基层的一部分的俯或仰视图，其示出各种不同的沟槽形态；
图5为图4A的局部截面视图A-A；
图6为图4A的局部截面视图B-B；
图7为替代可扩张构件在展开或平坦形态中的局部俯视图；以及
图8为另一种实例电极组件的俯或仰视图。
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。
某些治疗旨在临时或永久中断或修改选择神经功能。在一些情况下，神经为是交感神经。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。在一个实施例中，靶组织包括肾动脉和相关联的肾神经。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、肺静脉隔离、肺静脉消融、肿瘤消融、良性前列腺增生疗法、疼痛管理、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可用于消融被设置在邻近肾脏K的神经(例如，肾神经)(例如，被设置在肾动脉RA周围的肾神经)。在使用过程中，交感神经消融器械120可通过血管，如主动脉A被推进至肾动脉RA内的一个位置。这可包括通过引导护套或导管14推进交感神经消融器械120。当按需要进行定位时，交感神经消融器械120可进行激活以激活一个或多个电极(未示出)。这可包括将交感神经消融医疗器械120操作性地联接至控制单元110，其可包括RF发生器，从而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在控制单元110上的连接器22的和/或被联接至控制单元110的电线24的连接器20的电线或传导构件18。在至少一些实施例中，控制单元110也可用于供给/接收适当的电能和/信号以激活一个或多个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，电极可消融如下面所述的组织(例如，交感神经)且传感器可被用于检测所需的物理和/或生物参数。
在一些实施例中，交感神经消融器械120可包括细长管状构件或导管轴122，如图2中所示。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被推进至靶标部位。在一些实施例中，细长管状构件或导管轴122可被配置成在引导护套或导管14内被滑动地推进至靶标部位。在一些实施例中，细长管状构件或导管轴122可被配置成在引导护套或导管14或其组合上被推进至靶标部位。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、其周围或其附近。
例如，如在图2中所示，在一些实施例中，根据多个通常为圆柱形治疗区A-D，电极组件可被布置在可扩张构件130上，在此处所示的是在扩张状态中。在其他实施例中，可扩张构件130或治疗系统的其他部件可包括不在治疗区中的或以其他方式未被使用或被配置成输送治疗能量的额外的电极组件。
在图3中进一步地示出了治疗区A-D和相关联的电极组件140a-d，其为图2所示的可扩张构件130的一部分的“展开”描述。治疗区A-D彼此沿纵轴线L-L为纵向相邻，且可进行配置以使通过电极组件所施加的能量产生可能重叠或可能不重叠的治疗。通过纵向相邻的双极电极组件140a-d所施加的治疗可以是沿纵轴线L-L的周向非连续的。例如，参照图3，在治疗区A中所产生的损伤可能在一些实施例中与在治疗区B中所产生的损伤绕圆周(在该视图中为关于L-L成横向地)的重叠最小化。然而，在其他的实施例中，通过电极组件，如图3中所示的电极组件所施加的能量可能沿纵向、沿圆周和/或以其他方式在至少一定程度上发生重叠。每个电极片组件可包括4个主要元件，其为远侧电极片150a-d、中间尾部160a-d、近侧电极片170a-d、近侧尾部180b、d(未示出用于电极片组件140b和140c的近侧尾部)。
图4A示出实例电极组件200的俯视图。电极组件200可被构造为具有多层的柔性电路。这种层可以是连续的或不连续的，即由离散部分所组成。如在图5和6中所示，绝缘的基层202可为电极组件200提供基础。基层202可由聚合物，如聚酰亚胺构造而成，然而也可考虑其他材料。由多个离散迹线构成的传导层204可层叠在基层202的顶部上。例如，传导层204可以是电沉积铜层。也可考虑其他材料。绝缘层206可离散地或连续地层叠在传导层204的顶部上，从而传导层204可在基层202和绝缘层206之间被流体密封。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0.01mm厚至约0.02mm厚。在其他实施例中，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。
在图4A中示出的电极组件200可包括远侧电极片208。在该区域中，基层202可形成矩形形状。这不旨在进行限制。可考虑其他形状。组件的片和其他部分可包括圆形的或弯曲的拐角部、过渡部和其他部分。远侧电极片208可包括多个层叠在基层202的顶部上的离散迹线。这些迹线可包括接地迹线210、有源电极迹线212和传感器迹线214。接地迹线210可包括横向地偏离传感器接地片218的细长电极支撑件216。传感器接地片218可被电联接至接地迹线210的细长电极支撑件216并可位于远侧电极片208的中心处。桥接部220可将传感器接地片218的最远侧部分连接至接地迹线210的细长电极支撑件216的远侧部分。随着行进至传感器接地片218，桥接部220在宽度上逐渐变细。在一些实施例中，桥接部220可具有相对均匀且薄的宽度以获得所需量的柔性。细长的电极支撑216在其近端处的宽度可逐渐变细，然而，这不是必需的。在一些实施例中，细长电极支撑件216可在其近侧部分突然地过渡至薄得多的迹线以实现所需量的柔性。通常，在示出缩颈处的迹线的曲率可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优化以向作为整体的电极组件200提供尺寸稳定性，从而在布置和使用期间避免变形。
系统100可用于执行根据本发明的一个非限制性实施例的治疗方法。例如，控制单元110可被可操作地联接至消融器械120，其可被插入身体通道中以使可扩张构件130(具有多个电极组件)可被置于邻近需要治疗的身体通道的第一区段处。可根据常规的方法在需要治疗的身体通道的第一区段处放置消融器械120，例如，在透视导向下在导丝上进行。一旦插入，可扩张构件130可被制成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在约2-10atm下对流体加压而实现。这可使可扩张构件130的电极和/或电极组件与身体通道的第一区段相接触。
在一些实施例中，球囊可由聚对苯二甲酸乙二醇酯(PET)制成且基层202可用粘合剂被结合至球囊。基层202一般是平坦的且比起稍软的圆球囊更硬。一般是平坦的电极组件200可在使用后的再折叠期间抵制顺从圆形的球囊形状，这可能需要很高的取回力。在一些情况下，一般是平的电极组件200可在其边缘产生卡住点，其可能导致电极组件200的分层。
可能需要使用包括具有被联接至其的柔性电路的球囊的医疗器械，如本文所述。然而，在一些情况下，柔性电路可能包括相对刚性的材料。因此，如果球囊缩放，柔性电路则趋于平坦化和/或加宽。当如此进行配置时，柔性电路或其边缘可在将医疗器械(例如，包括固定的柔性电路)向近侧缩回至导引导管中时抓在导引导管的边上。本文所公开的医疗器械包括可减少柔性电路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)的一端上的可能性，从而产生减少的取回力的结构特性。
基层202可包括多个沟槽、切口或凹口203以提供增加的柔韧性。在一些实施例中，沟槽203和圆形/弯曲的电极片边缘可加强组件对从可扩张器械发生分层的阻力，如在一些情况下，当可扩张器械重复扩张和收缩(其也可能是从保护性护套进行的布置和撤回至保护性护套中)时可能发生分层，例如当在程序过程中治疗多个位点时所需要的。沟槽203可能导致机械软化的基层202，其产生更受控制的球囊再折叠行为以及用较小的撤回力实现更强健的球囊撤回。在一些实施例中，在需要再折叠的地方，可按一定方向和数量放置沟槽203。在一些实施例中，如在图4E中所示的，沟槽203可被布置在电极片208的拐角部，以对电极组件200进行预设置以在电极片208的边缘产生卷曲而非保持平坦。
在一些实施例中，沟槽203可以是基层202中的激光烧蚀或蚀刻区。在至少一些实施例中，沟槽203可使用准分子激光而形成。替代地，也可利用其他激光、包括机械工具的其他切割工具等。沟槽203可以是移除基层202总厚度的5-80％的区域或移除基层202总厚度的约5-60％的区域或移除基层202总厚度的约10-40％的区域或移除基层202总厚度的约10-20％的区域。这些仅仅是实例。沟槽203可以是基层202中的划线、压缩区域或切口。沟槽203可使用产生具有基层202的减小的厚度的区域或以其他方式产生基层202沿沟槽203线折叠、扭曲或弯曲的区域的工艺而形成。沟槽203可仅在基层202的顶或底表面中制成或可在基层202的顶和底表面中制成。在顶和底表面中具有沟槽203的实施例中，在顶表面中的沟槽203可与在底表面中的沟槽203相对齐。在其他实施例中，在顶表面中的沟槽203可与在基层202的底表面中的沟槽203相偏离，如在图5中所示。在一些实施例中，沟槽203可在基层202的整个表面上制成，如在图4A中所示。在一些实施例中，沟槽203可在基层202的一部分上制成，如在图4E中所示。在一些实施例中，沟槽203可在电极片208的区域中的基层202中制成，如在图7中所示。在添加传导层204或其他层之前可在基层202中制成沟槽203。在一些实施例中，消融器械120可通过在基层202中形成沟槽203、在沟槽基层202上形成电路以创建电极组件200、将沟槽电极组件200固定至可扩张构件130上并将可扩张构件130附接至导管轴(例如，导管轴122)而制成。
在一些实施例中，沟槽203可形成格子或交叉排线，如在图4A、4B和4D中所示。在一些实施例中，沟槽203可以是一系列大致平行的线，如在图4C和4H中所示。沟槽203可相对于电极组件200的中轴线G-G而取向在任何方向上。在一些实施例中，沟槽大致平行于电极组件200的中轴线G-G，如在图4H中所示。纵沟槽可向电极组件200提供径向柔性。在一些实施例中，沟槽203包括平行和垂直于中轴线G-G的沟槽，如在图4A和4B中所示。在一些实施例中，沟槽203按与中轴线成角度的方式进行取向，如在图4C和4D中所示。在一些实施例中，沟槽203可仅位于电极片208的拐角部，如在图4E中所示。在一些实施例中，沟槽203是弯曲的，如在图4F中所示。在一些实施例中，基层202可包括多个不同区域，其在不同取向上具有沟槽203，如在图4E、4F和4G中所示。
图5示出远侧电极片208的局部截面A-A。所示的电极222层叠在绝缘层206的一部分上，其可具有多个通道(例如，孔)以使电极222能够联接至传导层204的接地迹线210的细长电极支撑件216。图5示出与在基层202的底表面中的沟槽203相偏离的在顶表面中的沟槽203。
如在图4A中所示，接地电极迹线210和有源电极迹线212可包括多个电极。每个电极迹线可设有三个电极222，然而，也可使用更多或更少的电极。此外，每个电极222可具有圆角以减少钩挂其他器械和/或组织的倾向。尽管上面已在双极电极组件的背景下描述了与其相关联的电极222和迹线，那本领域的技术人员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和242相关联的电极可被用作单极电极，其中接地迹线210在那些电极的通电期间是断开的。
传感器迹线214可位于远侧电极片208的中心且可包括面向传感器接地片218的传感器功率片224。这些片可连接至温度传感器226，如热电偶(例如，T型构造：铜/康铜)或热敏电阻的功率极和接地极，如在图6中以局部截面所示出的。
温度传感器226可向近侧被连接至传感器功率片224且可向远侧被连接至传感器接地片218。为了有助于减少总厚度，温度传感器226可位于基层202内的开口内。在一些实施例中，温度传感器226可以是热敏电阻。如图所示，温度传感器226可位于远侧电极片208的非组织接触侧。因此，当被结合至最终的器械，如导管120中时，温度传感器226被俘获在电极结构和球囊之间。这是有利的，这是因为在表面安装的电气组件，如热敏电阻，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。进一步地，由于温度传感器的布置，其可测量代表组织和电极222的温度。
从矩形远侧电极片208至中间尾部228，组合的基层202、传导层204和绝缘层206的横向宽度可减少。在这里，如在图4A中所示，传导层204可形成为包括中间接地线230、中间有源电极线232和中间传感器线234，他们可分别为远侧电极片208的接地迹线210、有源电极迹线212和传感器迹线214的共同扩展的迹线。
从中间尾部228开始，组合的基层202、传导层204和绝缘层206的横向宽度可增加以形成近侧电极片236。可按类似于远侧电极片208的方式构造近侧电极片236，其电极的几何形状和温度传感器的布置大致相同，然而也可存在有各种差异。然而，如图所示，近侧电极片236可关于沿中间接地线230延伸的中轴线G-G沿横向偏离远侧电极片208。中间有源电极线232和中间传感器线234可在关于中轴线G-G的相应平行轴线上沿横向与近侧电极片236共同扩展。
从近侧电极片236开始，组合的基层202、传导层204和绝缘层206的横向宽度可减少以形成近侧尾部238。近侧尾部238可包括近侧接地线240、近侧有源电极线242和近侧传感器线244，以及中间有源电极线232和中间传感器线234。近侧尾部238可包括使得能够联接至一个或多个子线束和/或连接器并最终至控制单元110的连接器(未示出)。这些线中的每一个均可关于中轴线G-G沿各平行的轴线延伸。
如图所示，电极组件200可具有远侧电极片208和近侧电极片238关于轴线G-G的非对称布置。进一步地，两个电极片的接地电极连同中间和近侧接地线230/240一起可大致沿轴线G-G相对齐。已发现该布置可具有很多优点。例如，通过基本上共用相同的接地迹线，近侧尾部的宽度可能仅为中间尾部228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238可能比两个中间尾部228更窄。
在一些实施例中，多个电极组件310可按与可扩张构件130的纵轴线L-L所成的一个角度进行扭转或倾斜。成角度的电极组件310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，成角度的电极组件310可有助于进行可扩张构件130的扭转和再折叠。在一些实施例中，沟槽203可基本上与可扩张构件130的纵轴线L-L相平行，如在图7中所示。在其他实施例中，沟槽203可包括交叉排线，可按与纵轴线L-L成角度的方式延伸，可仅在电极组件310的一部分上延伸，可弯曲或可在不同区域中以不同的角度延伸，如在图4B-4H中所示的沟槽相类似。
电极组件310可基本上沿其长度成线性，沿可扩张构件130的整个长度按与纵轴线所成的一个角度延伸。在其他实施例中，电极组件可在近侧区中平行于纵轴线延伸且随后在远侧区中被弯曲为成角度的取向。成角度的电极组件310可使球囊旋转并沿成角度的细长构件310的线折叠，这减少了将消融器械300取回至导引护套或导管14中所需的取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，这与之前已使用的8Fr导引导管相比在肾手术中提供了优势。成角度的电极组件310可减少剪切力或改进球囊的再折叠的轮廓效率，从而减少了电极组件从可扩张构件130发生的分层。在一些实施例中，成角度的电极组件310的基层202可具有如上面关于图4A-4G所讨论的方式进行取向的沟槽203。在一些实施例中，如在图7中所示，沟槽203可仅在电极片325的区域上延伸，且沟槽203可相对于纵轴线L-L在不同方向上延伸。
电极组件130可采用类似于本文所公开的电极组件和/或柔性电路的形式和功能。在至少一些实施例中，电极组件310可被直接附至可扩张构件130，且每个电极组件310可含有一个或多个电极片325。每个电极片325可包括一个或多个接地电极、一个或多个有源电极和温度传感器，如上面所讨论的。在一些实施例中，每个电极片325的电极和传感器可按图4A中所示的方式进行布置。在相邻的电极组件310上的电极片325可能是错开的，如在图7中所示。在其他实施例中，电极片325可具有沿可扩张构件130长度的形成了在可扩张构件130所在的内腔或血管中的至少一个完整的(360度)的周向环的螺旋取向。电极片325可在身体通道周围的组织内的一个位置上提供加热，而不会损坏身体通道的壁，从而扰乱围绕身体通道壁的组织中的神经。需要螺旋取向以有助于避免增加发生狭窄的风险，这可能会发生在电极被设置在与身体通道的纵轴线成法向的单个平面中时(即，形成周向环的圆形电极或电极组)。
在至少一些实施例中，电极组件的形式或布置可包括进一步的变型。例如，图8示出另一个实例电极组件400，其可与本文所公开的其他电极组件的形式和功能相类似。电极组件400可包括远侧电极片408和近侧电极片436。电极片408/436可包括类似于图4A中所示的电极组件200的电极、迹线、温度传感器等。此外，在至少一些实施例中，电极组件400可被联接至球囊和/或可扩张构件(例如，可扩张构件130)。电极组件400可包括基层402，其具有在其中形成的一个或多个沟槽403。基层402可沿电极组件400的顶和/或底表面而进行设置，从而使沟槽403可沿顶表面、底表面或两者而进行设置。沟槽可按合适的图案进行布置，该图案包括本文所述的那些图案中的任一图案。
中间尾部可在片408/436之间延伸。近侧尾部438可从近侧电极片436向近侧延伸。在至少一些实施例中，近侧电极片436可与近侧尾部438同中心的。换句话说，近侧尾部436可定位成，使其与近侧电极片236的中部相结合。因此，近侧电极片436可按基本上对称的方式相对于近侧尾部438或以其他方式从近侧尾部438沿横向延伸(例如，在两侧上从近侧尾部238沿横向延伸相同的距离)。也可以看出，在近侧电极片436沿横向延伸处通过近侧电极片436和近侧尾部438所形成的角度在近侧电极片436的两侧上大致是相同的。由于一些原因可能需要这种布置。例如，通过使近侧电极片436与近侧尾部438同中心，如果在导管或套管中缩回电极组件400，那么近侧电极片436则不太可能在导管或套管的一端上形成阻碍或被钩住。
还应理解的是在其他实施例中，中间尾部228也可位于片408/436上的中心处。例如，中间尾部228可在片408/436之间延伸且可位于近侧电极片436、远侧电极片408或两个片408/436上的中心处。
换句话说，中间尾部228可定位成，使其与近侧电极片238的中部、远侧电极片408的中部或两个片408/436的中部相结合。因此，近侧电极片436、远侧电极片408或两者可按基本上对称的方式相对于中间尾部228或以其他方式从中间尾部228沿横向延伸(例如，在两侧上从中间尾部228沿横向延伸相同的距离)。在一些情况下，在近侧电极片436沿横向延伸处通过近侧电极片436和中间尾部228所形成的角度在近侧电极片436的两侧上大致是相同的。同样地，在一些情况下，在远侧电极片408沿横向延伸处通过远侧电极片408和中间尾部228所形成的角度在远侧电极片408的两侧上大致是相同的。由于一些原因可能需要这种布置。例如，通过使近侧电极片436和/或远侧电极片408与中间尾部228同一中心，如果在导管或套管中推进和/或缩回电极组件400，那么电极片436则不太可能在导管或套管的一端上形成阻碍或被钩住。
在使用中，消融器械120可通过血管被推进到邻近靶组织的位置(例如，在肾动脉内)。在一些实施例中，靶组织可以是被设置在肾动脉周围的一个或多个肾神经。当进行适当地定位时，可扩张构件130可从塌缩输送形态扩张至扩张形态。这可将有源电极靠着血管壁进行放置。可激活有源电极。消融能量在双极配置中可从有源电极进行传输通过靶组织(可对肾神经进行消融、调制或以其他方式影响肾神经处)并返回通过接地电极或在单极配置中返回通过共用接地电极。
可用于消融器械120(和/或本文所公开的其他器械)的各种组件的材料可包括通常与医疗器械相关联的那些。为了简单起见，下面的讨论参考了消融器械120。然而，这并不旨在限制本文所述的器械和方法，这是因为讨论也适用于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/或可扩张构件的组件。
消融器械120和其各种组件可由金属、金属合金、聚合物(其中的一些例子如下公开)、金属-聚合物复合材料、陶瓷、它们的组合等或其他合适的材料制成。合适的聚合物的一些实例可包括聚四氟乙烯(PTFE)、乙烯-四氟乙烯(ETFE)、氟化乙烯丙烯(FEP)、聚氧甲烯(POM，例如，可从DuPont购得的)、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)、基于醚或酯的共聚物(例如，丁烯/聚(亚烷基醚)邻苯二甲酸酯和/或其他聚酯弹性体(如可从DuPont购得的)、聚酰胺(例如，可从Bayer购得的或可从Elf Atochem购得的)、弹性体聚酰胺、嵌段聚酰胺/醚、聚醚嵌段酰胺(PEBA，例如，可按商品名购得的)、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、聚对苯二甲酸丁二醇酯(PBT)、聚对苯二甲酸乙二醇酯(PET)、聚三亚甲基对苯二酸酯、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)、聚对苯二甲酰对苯二胺(例如，)、聚砜、尼龙、尼龙-12(如可从EMSAmerican Grilon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-b-异丁烯-B-苯乙烯)(例如，SIBS和/或SIBS 50A)、聚碳酸酯、离聚物、生物相容性聚合物、其他合适的材料或其混合物、组合和共聚物、聚合物/金属组合物等。在一些实施例中，护套可混合有液晶聚合物(LCP)。例如，混合物可含有高达6％的LCP。
合适的金属和金属合金的一些实例包括不锈钢，如304V、304L和316LV不锈钢；软钢；镍-钛合金，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625；UNS:N06022，如UNS:N10276，如其他合金等)、镍-铜合金(例如，UNS:N04400，如400、400、400等)、镍-钴-铬-钼合金(例如，UNS:R30035，如等)、镍-钼合金(例如，UNS:N10665，如)、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(例如，UNS:R30003，如等)；铂富集不锈钢；钛；其组合；等；或任何其他合适的材料。
如本文所提到的，在市售的镍-钛或镍钛诺合金的家族内的种类被指定为“线性弹性的”或“非超弹性的”，虽然其可能在化学性上与常规的形状记忆和超弹性品种相类似，但仍可表现出不同且有用的机械性能。线性弹性和/或非超弹性镍钛诺可与超弹性镍钛诺相区分，这是因为线性弹性和/或非超弹性镍钛诺在其应力/应变曲线中未显示出像超弹性镍钛诺的基本上为“超弹性平坦区域”或“标志区域”。相反地，在线性弹性和/或非超弹性镍钛诺中，随着可恢复应变增加，应力继续以大致线性或稍有些但却不一定是完全线性的关系增加直到塑性变形开始或至少处于比可从弹性镍钛诺看到的超弹性平坦区域和/或标志区域更具线性的关系中。因此，为了本发明的目的，线性弹性和/或非超弹性镍钛诺也可被称作“基本上”线性弹性和/或非超弹性镍钛诺。
在一些情况下，线性弹性和/或非超弹性镍钛诺也可与超弹性镍钛诺相区分，这是因为线性弹性和/或非超弹性镍钛诺在基本上保持弹性(例如，在发生塑性变形前)可接受高达约2-5％的应变，而超弹性镍钛诺仅可在塑性变形前接受约8％的应变。这两种材料均可与线性弹性材料，如不锈钢(其也可基于其组成而进行区分)相区分，不锈钢仅可在塑性变形前接受约0.2至0.44％的应变。
在一些实施例中，线性弹性和/或非超弹性镍钛合金是一种合金，其未显示出在大的温度范围内可通过差示扫描量热法(DSC)和动态金属热分析(DMTA)检测到的任何马氏体/奥氏体相变化。例如，在一些实施例中，在线性弹性和/或非超弹性镍钛合金中不具有在约-60摄氏度(℃)至约120℃的范围中可通过DSC和DMTA分析检测到的马氏体/奥氏体相变化。因此，对于实现这种非常宽的温度范围的温度来说，这种材料的机械弯曲性能总的来说是惰性的。在一些实施例中，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基本上与在体温的机械性能相同，例如，这是因为其未显示出超弹性平坦区域和/或标志区域。换句话说，在宽温度范围内，线性弹性和/或非超弹性镍钛合金保持了其线性弹性和/或非超弹性特征和/或性能。
在一些实施例，线性弹性和/或非超弹性镍钛合金可含有在约50至约60重量百分比范围中的镍，其他的则基本上为钛。在一些实施例中，组合物含有在约54至约57重量百分比范围中的镍。合适的镍钛合金的一个实例为可从日本神奈川县的Furukawa TechnoMaterial Co.购得的FHP-NT。在美国专利号5238004和6508803中公开了镍钛合金的一些实例，其通过引用并入本文。其它合适的材料可包括ULTANIUMTM(可从Neo-Metrics购得)以及GUM METALTM(可从Toyota购得)。在一些其他实施例中，超弹性合金，例如超弹性镍钛诺可用于实现所需的性能。
在至少一些实施例中，消融器械120的部分也可掺杂有不透射线的材料、由其制成或以其他方式包括不透射线的材料。不透射线的材料被理解为能在医疗手术期间在荧光透视屏上或以另一种成像技术产生相对明亮的图像。该相对明亮的图像有助于消融器械120的用户确定其位置。不透射线的材料的一些实例可包括，但不限于，金、铂、钯、钽、钨合金、载有不透射线填料的聚合物材料等。另外，其他不透射线的标记带和/或线圈也可结合至消融器械300的设计中以实现相同的结果。
在一些实施例中，一定程度的磁共振成像(MRI)相容性可被赋予至消融器械120中。例如，器械的部分可由基本上不会使图像扭曲并创建可观的伪影(即，图像中的间隙)的材料制成。例如，某些铁磁性材料可能是不合适的，这是因为其在MRI图像中创建了伪影。在这些实施例中的一些以及在其他实施例中，消融器械300的部分也可由MRI机器能成像的材料制成。一些表现出这些特征的材料，包括，例如钨、钴-铬-钼合金(如，UNS：R30003，如等)、镍-钴-铬-钼合金(如，UNS：R30035，如等)、镍钛诺和类似物和其它。
2013年1月25日提交的题为“重建身体通道的组织或邻近身体通道的组织的方法和器械”的序列号为13/750,879的美国专利申请，当前为美国专利申请公开US20130165926A1，其通过引用并入本文。
应理解的是本发明在多个方面上仅是说明性的。在不超越本发明范围的前提下，可在细节上，特别是形状、大小和步骤的安排事项上做出变化。这可包括在适当的程度上使用用于其他实施例中的一个实例实施例的特性中的任何特性。当然，本发明的范围是以表述所附权利要求所用的语言进行限定的。

Claims (15)

1.一种用于神经消融的医疗器械，其包括：
导管轴；
可扩张构件，其被联接至所述导管轴，且所述可扩张构件具有纵轴线、近侧区域、远侧区域以及在所述近侧区域和远侧区域之间延伸的本体；以及
被附接至所述可扩张构件的所述本体的多个柔性元件，所述多个柔性元件包括多个电极组件，其中所述柔性元件的每一个包括所述多个电极组件中各自对应的一个，其中所述多个柔性元件的每一个包括基板，所述基板为绝缘基层的形式且具有多个形成在其中的细长沟槽，其中所述多个电极组件设置在所述基板以及所述多个形成在其中的细长沟槽的至少一部分上。
2.根据权利要求1所述的医疗器械，其中所述基板包括聚合物。
3.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽仅被设置在所述基板的上表面和下表面中的一个上。
4.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽被设置在所述基板的上表面和下表面上。
5.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽的至少一部分沿所述基板以与所述可扩张构件的所述纵轴线成一个角度地延伸。
6.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽在一个以上的方向沿所述基板延伸。
7.根据权利要求1-2中任一项所述的医疗器械，其中所述细长沟槽中的至少一部分基本上彼此平行。
8.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽限定出交叉阴影线图案。
9.根据权利要求1-2中任一项所述的医疗器械，其中所述细长沟槽是按与预定的折叠图案相关联的图案进行设置的。
10.根据权利要求1-2中任一项所述的医疗器械，其中所述多个细长沟槽基本上在所述基板的整个长度上延伸。
11.根据权利要求1-2中任一项所述的医疗器械，其中所述电极组件从所述柔性元件延伸出来，其中一个或多个所述细长沟槽是沿所述多个电极组件的近侧边缘进行布置的。
12.根据权利要求1-2中任一项所述的医疗器械，其中在相邻柔性元件上的电极组件在纵向上是错开的。
13.根据权利要求1-2中任一项所述的医疗器械，其中所述多个柔性元件沿所述可扩张构件以相对于所述可扩张构件的所述纵轴线的成一个角度地延伸。
14.根据权利要求1-2中任一项所述的医疗器械，其中所述柔性元件包括远侧电极片、近侧电极片以及从所述近侧电极片向近侧延伸的近侧尾部；且其中所述近侧电极片与所述近侧尾部同中心。
15.一种制造权利要求1所述的医疗器械的方法，所述方法包括：
在所述基板中形成所述多个细长沟槽，从而形成带沟槽基板；
在所述带沟槽基板上形成电路；
将所述带沟槽基板固定至所述可扩张构件；以及
将所述可扩张构件附接至所述导管轴。
CN201480057006.0A 2013-10-15 2014-10-13 医疗器械球囊 Expired - Fee Related CN105636537B (zh)

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