CN108095821A - 孔部肾神经消融 - Google Patents

孔部肾神经消融 Download PDF

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CN108095821A
CN108095821A CN201810045525.5A CN201810045525A CN108095821A CN 108095821 A CN108095821 A CN 108095821A CN 201810045525 A CN201810045525 A CN 201810045525A CN 108095821 A CN108095821 A CN 108095821A
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blood vessel
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M.R.维尔拉德
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Boston Scientific Scimed Inc
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A61B2018/00345—Vascular system
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
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    • A61B2018/00434—Neural system
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0004—Applications of ultrasound therapy
    • A61N2007/0021—Neural system treatment
    • A61N2007/003—Destruction of nerve tissue
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
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    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/041—Controlled or regulated

Abstract

一种导管，包括具有远端端部和近端端部的长形轴，其中所述导管包括处于其远端端部处的热敏元件。所述热敏元件可以用于消融程序或其它程序来加热邻近血管的组织。在一些情况下，所述热敏元件可以定位在第一血管中，并且可以进行操作来加热邻近第二血管或邻近第一血管与第二血管之间的孔的组织。此外，所述导管可以包括可膨胀部分，所述热敏元件可以连接或定位在所述可膨胀部分上。可膨胀部分可以包括篮状物或笼状物、气囊、形状记忆和可成形部分、和/或其它机械膨胀器。

Description

孔部肾神经消融
相关申请的交叉引用
本申请要求2011年11月8日提交的美国临时申请序列号61/557,239的权益，其全部公开内容通过引用并入本文。
本申请为申请日为2012年11月7日、申请号为201280054868.9、名称为“孔部肾神经消融”的原申请的分案申请。
技术领域
本公开涉及用于插入身体血管中的装置。更具体地，本公开涉及用于组织消融程序的装置。
背景技术
常规导管和相似装置被使用在医疗程序中来实现进入身体的内部区域。常常在其中使用导管的身体的例示性区域处于心血管系统中。通常，用于插入身体中的导管可以具有用于插入身体内部的远端端部和保持在身体外部的近端端部。导管可以用于多种医疗程序，包括但不限于：消融程序、血管清理程序、治疗程序、诊断程序和探索程序等。
发明内容
本公开涉及使用医疗装置结构和组件的数种替代或补充的设计、材料和方法。尽管应指出的是存在常规的导管和相似装置，但是仍然需要对那些装置进行改进。
因此，本公开的一个例示性实施例可以包括一种导管，其具有长形轴，所述长形轴具有处于其相对端部处的远端端部和近端端部。长形轴的远端端部可以包括可定位在第一血管的管腔中的热敏元件，其可以用于通过使用从热敏元件发射的能量场或通过使用技术，来加热和/或消融邻近第二血管和/或第一血管与第二血管之间的孔(ostium)的组织和/或其它组织。另外，导管的远端端部可以被构造成发生膨胀，以促进将热敏元件放置在第一血管中的目标区域附近，并且加热邻近第二血管和/或第一血管与第二血管之间的孔的血管周组织和/或其它组织。导管的可膨胀部分的例示性示例可以包括笼状物(cage)、气囊、形状记忆和可成形部分以及其它可膨胀特征，其被构造成在其上包括至少一个热敏元件。在示例中，导管可以包括具有管腔的护套，所述长形轴穿过所述管腔插入，其中所述护套可以在它覆盖可膨胀特征时促进将可膨胀特征定位在第一位置，并在护套缩回时促进将可膨胀特征定位在第二位置。此外，导管的例示性示例可以包括连接至热敏元件的引导线和激活线或导电线，其中所述热敏元件从它们所连接至的激活线接收电力，并且引导线可以被构造成延伸到第二血管中，以接收从热敏元件输送来的热能，来消融、改变或破坏第二血管和/或第一血管与第二血管之间的孔的周围的血管周组织和/或其它组织。
以上对一些示例性方面的概述并不旨在描述本公开的每个所公开实施例或每个实施方式。
附图说明
结合附图考虑以下对多个实施例的详细描述可以更全面地理解本公开，附图中：
图1是右肾和从腹主动脉伸出的肾血管系统的示意图；
图2是肾动脉的组织层的截面示意图；
图3是根据本公开一个方面的插入第一血管中消融第二血管中的组织的导管设备的示意图；图4是根据本公开一个方面的沿第一和第二血管的线4-4所取的图3的示意性截面图，其中导管设备已被移除；
图5A是根据本公开一个方面的处于第一位置的导管设备的示意性截面图；
图5B是根据本公开一个方面的处于第二位置的图5A的导管设备的示意性截面图；
图5C是沿线5C-5C所取的图5B的导管设备的示意性横截面图；
图6A是根据本公开一个方面的处于第一位置的导管设备的示意性截面图；
图6B是根据本公开一个方面的处于第二位置的图6A的导管设备的示意性截面图；
图6C是沿线6C-6C所取的图6B的导管设备的示意性横截面图；
图7A是根据本公开一个方面的处于第二位置的导管设备的示意性截面图；
图7B是沿线7B-7B所取的图7A的导管设备的示意性横截面图；
图8A是根据本公开一个方面的处于第二位置的导管设备的示意性截面图；
图8B是沿线8B-8B所取的图8A的导管设备的示意性横截面图；
图9A是根据本公开一个方面的处于第一位置的导管设备的示意性截面图；
图9B是根据本公开一个方面的处于第二位置的图9A中的导管设备的示意性截面图；并且图9C是沿线9C-9C所取的图9B的导管设备的示意性横截面图。
虽然本公开服从各种修改和替代形式，但是其特定情况已经通过示例方式在附图中示出并且将被详细描述。然而，应该理解的是：意图并非是将本公开的多个方面限制于所描述的特定实施例。相反，意图是覆盖落于本公开的精神和范围内的所有变型、等同方案和替代方案。
具体实施方式
对于以下定义的术语，这些定义将适用，除非在权利要求书中或在本说明书中的其它地方给出了不同的定义。
所有数值在本文中都被假定为被术语“大约”修饰，不管是否被明确地指出。术语“大约”通常是指一定范围的数字，其将被本领域的技术人员认为等同于所举值(即，具有相同的功能或结果)。在许多情况下，术语“大约”可以表示为包括被四舍五入到最接近有效数字的数字。
通过端点对数值范围的列举包括处于该范围内的所有数字(例如，1～5包括1、1.5、2、2.75、3、3.80、4和5)。
尽管公开了属于各种部件、特征和/或规格的一些适当的尺寸、范围和/或值，但是本领域的技术人员通过本公开的启发将理解所需的尺寸、范围和/或值可以偏离被明确地公开的那些。
如在本说明书和所附权利要求书中使用的，单数形式“一”、“一个”和“该”包括复数的对象，除非内容另有明确规定。如在本说明书和所附权利要求书中使用的，术语“或”在其意义上通常被采用来包括“和/或”，除非内容另有明确规定。
以下详细描述应该参考附图来阅读，其中不同附图中的相似元件被相同地编号。详细描述和附图，其并不一定按比例进行绘制，示出了例示性实施例而且并不旨在限制本公开的范围。所示例示性实施例只意在作为示例。任何例示性实施例的所选特征都可以被合并到附加实施例中，除非有清楚的相反陈述。
图1是肾10和包括从腹主动脉20横向地分支出的肾动脉12的肾血管系统的示例图示。一般来说，左肾和右肾从腹主动脉20的相应右侧表面和左侧表面被供应血液。右肾动脉和左肾动脉中的每个从腹主动脉20延伸至邻近肾的肾门18的相应肾窦，并且分支成段动脉和肾10内的动脉。通常，肾动脉和肾接收大约20％的总心输出量，其对于典型的人来说，代表每分钟穿过肾的大约1200mL的血流。
在图1中示出的还有右肾上腺16，其可以一般被称为右副肾腺。肾上腺16通常是位于肾10之上的星形内分泌腺。肾上腺的主要功能可以是用以调节身体通过分别包括皮质醇和副肾素(肾上腺素)的皮质甾类和儿茶酚胺的合成而发生的应激反应。环绕肾10、肾上腺16、肾血管12和相邻肾周脂肪的是肾筋膜(未示出)，其是从腹膜外结缔组织衍生的筋膜囊。
身体的自主神经系统控制血管、消化系统、心脏和腺中的平滑肌的不自主动作。自主神经系统分成交感神经系统和副交感神经系统。一般来说，副交感神经系统通过降低心率、降低血压和模拟消化来准备身体以便休息。交感神经系统可以通过提高心率、提高血压和/或提高新陈代谢来实现身体的战斗或逃跑反应。
在自主神经系统中，源自中枢神经系统并延伸至各个神经节的纤维被称为节前纤维，而从神经节延伸至效应器官的那些纤维被称为节后纤维。交感神经系统的激活是通过来自肾上腺16的副肾素(肾上腺素)以及在较小程度上的去甲肾上腺素的释放来实现的。副肾素的这种释放是由从节前交感神经释放的神经递质乙酰胆硷触发的。
肾和输尿管(未示出)可以由肾神经14支配。图1绘出了肾血管系统的例示性交感神经支配，主要是肾动脉12的神经支配。肾血管系统的交感神经支配的功能可以包括肾血流和血压的调节、凝乳酶释放的刺激、以及水和钠离子再吸收的直接刺激等功能。
支配肾血管系统的神经14的大部分可以是源自肠系膜上神经节26的交感神经节后纤维。肾神经14可以沿着肾动脉12大体轴向地延伸、在肾门18处或附近进入肾10、沿随肾动脉12在肾10内的分支并延伸至肾10的个体肾单位。其它肾神经节比如肾神经节24、肠系膜上神经节26、左右主动脉肾神经节22、和腹腔神经节28也可以支配肾血管系统。
用于肾神经支配的焦点是肾动脉12与腹主动脉20之间的孔30(例如，图1中的打点区域)。一般来说，源自肾神经节的节后神经纤维沿着包括孔30的路径支配肾动脉12。
经由主要在脊髓节段T10-T12和L1处起源的受支配肾血管系统来传达去往肾10的交感神经信号。副交感神经信号主要在脊髓节段S2-S4处以及从下脑的延髓起源。交感神经信息流行进穿过交感干神经节，在这里一些可以形成突触，而另一些在主动脉肾神经节22处形成突触。突触后交感神经信号然后沿着肾动脉12的神经14行进至肾10。突触前副交感神经信号在它们于肾10上或附近形成突触之前行进至肾10附近的部位。
肾神经14可以支配肾动脉12的壁的平滑肌，并沿着肾动脉12的壁从孔30(例如，肾动脉12与主动脉20之间的开口以及血管的与之相邻的部分)以大体轴向或纵向的方式沿长度方向延伸，如在图1中看出的。肾动脉12的平滑肌可以处于自主神经系统的不自主控制下。交感神经活性的提高例如趋于收缩平滑肌，其减小肾动脉12的管腔的直径并降低血液灌流。交感神经活性的降低趋于使平滑肌松弛，其可以导致血管舒张以及血液灌流和肾动脉12的管腔的直径的增大。相反地，提高的副交感神经活性趋于松弛平滑肌，而降低的副交感神经活性趋于使平滑肌收缩。
如图2中绘出的，穿过肾动脉12的局部纵截面示出了包括与肾动脉12相邻的孔30的肾动脉12的壁的各个组织层。肾动脉12的最内层包括内皮32，其是内膜34的最内层并由内部弹性隔膜33支承。内皮32是单层细胞，其接触流动穿过肾动脉12的管腔的血液。内皮细胞通常是多边形、椭圆形或纺锤形的，并具有非常独特的圆形或椭圆形核心。内皮32的细胞被含入数个血管功能，包括经由血管收缩和血管舒张控制血压、血液凝结以及用作肾动脉12的管腔内的内含物与周围组织之间的屏障层，比如使内膜34与介质36和外膜38分离的内膜34的隔膜。内膜34的隔膜或浸渍层的33是精细的、透明的无色结构，其是高弹性的，并且通常具有纵向波形图案。
与内膜34相邻的是介质36，其是肾动脉12的中间层。介质36由平滑肌和弹性组织构成。介质36可以通过它的颜色以及通过它的纤维的横向排列被轻松地识别。例如，介质36可以主要由以薄板状方式或薄片配置且围绕肾动脉12的壁圆形地设置的平滑肌纤维束组成。肾动脉的最外层是外膜38，其由结缔组织构成。外膜38包括纤维母细胞40，其在伤口愈合中发挥重要作用。此外，在图2中，肾神经14被示出为邻近外膜38，其将最终经由孔30进入肾动脉12中，并沿着肾动脉12的壁纵向地延伸。肾神经14的主干主要处于肾动脉12的外膜38之中或之上，且某些分支进入介质36中以支配肾动脉12的平滑肌。
与本公开一致的装置、系统和程序可以用于血管和神经系统的所描述特征，并且可以涉及向与肾动脉12相关联的孔30和/或孔30的相邻区域输送热能，以便改变、干扰或终止肾神经14的活动，或服务于与本公开一致的另一特征。在一例示性示例中，如在图3和4中看出的，导管50包括具有与之连接的热敏元件58的长形构件52，并且延伸穿过其中的引导线54可以插入血管系统中以及第一血管60例如腹主动脉20的管腔61中。导管50可以被定位成使得热敏元件58位于第一血管60的处于孔30处或附近的内壁处或附近。此外，在例示性示例中，引导线54可以延伸穿过长形构件52的远端端部52a的第一终端53a，并进入第二血管62例如肾动脉12的管腔63中(可选步骤)，并且可以用作地线或者可以具有另一功能。在长形构件52的可膨胀部分或特征51处或附近连接至长形构件52的热敏元件58可以发送热能66穿过孔30(例如，图4中的虚线圆圈)处或附近的目标区域68至第二血管62中引导线54，以完成双极电路径并实现改变、干扰或终止肾神经活动，或用于另一相似或不同治疗效果。因此，从热敏元件58发射的热能66可以被集中以穿过孔30附近的神经节24，从而将电路径局限于孔30的区域。
替代地或附加地，热敏元件58可以采用单极电路径，使得热敏元件58不采用引导线54来形成双极电连接。在热敏元件58的单极取向中，引导线54可以保持在第一血管60中，因为不需要它来达到向目标区域68引导热能(例如，射频--“RF”、超声能量等)的目的。当热敏元件58未采用引导线54作为地线或者不包括引导线54时，可以采用血管系统外的接地装置来协助引导从热敏元件58发射的能量流，或者可以采用不同策略地放置的接地装置。例如，在一些情况下，地电极或返回电极可以定位在患者身体的外部上。一般来说，热敏元件58可以是电极(例如，圆柱形射频(RF)消融电极)或其它装置，其促进RF加热或超声加热或使用能量场的其它相似或不同类型的加热。
如在图5A、6A和9A中看出的，导管设备50的长形构件或特征52可以具有带第一终端53a的远端端部52a和带第二终端53b的近端端部52b，其中长形构件52的长度可以从第一终端53a到第二终端53b测得。第一终端53a可以是开放的，以可选地允许引导线54延伸穿过其中，以及用于其它目的。长形构件52的第二终端53b可以连接至把手和/或控制器或控制装置(未示出)，其用于控制远端端部52a的移动以及控制附接至远端端部52a的热敏元件58的操作，以及具有其它相似和不同的能力。如所论述的，导管50可以进一步包括引导线54，并且可以进一步包括具有远端端部56a和近端端部(未示出)的导电线56，其中线54、56可以基本上延伸长形构件52的长度。为了围绕和保护引导线54以及一个或多个导电线或激活线56，长形构件52可以形成管腔70，引导线54和导电线56可以延伸穿过所述管腔70。另外，导管50可以包括外部管状结构，例如护套72，其可以是可缩回的和/或被构造成允许长形构件52穿过其中缩回，被构造成可选地覆盖长形构件52的远端端部52a的至少一部分，如在图5A-9B中看出的。在护套72已经缩回的情况下，热敏元件58可以被构造成暴露出来，并用以抵接或放置成相邻于第一血管60与第二血管62之间的孔30，或者位于附近但是与孔30的壁间隔开(在离壁电极的情况下)。此外，延伸穿过护套72的长形构件52可以相对于护套72缩回，导致热敏元件被护套72覆盖。护套72可以由任何材料制成。例如，护套可以由聚合材料比如聚酰胺或聚乙烯或者另一材料制成。
长形构件52的远端端部52a可以包括可膨胀部分或特征51。可膨胀特征51可以是可膨胀的笼状物或篮状物、气囊或其它机械膨胀器。可膨胀特征51可以被构造成机械地连接至热敏元件58中的一个或多个，并且/或者热敏元件58可以放置成邻近可膨胀特征51。例如，多个热敏元件58可以连接至可膨胀特征51，并且可膨胀特征51可以被构造成从长形构件52缩回时的第一位置膨胀至第二位置，和/或在护套72相对于长形构件52和/或可膨胀特征51缩回时具有改变的形状。可膨胀特征51和长形构件52通常可以由任何材料制成。例如，可膨胀特征51和长形构件52的其余部分可以由以下材料制成：聚合物；金属或其它相似或不同的适当材料，其被构造成插入血管60、62中并且能够物理操控穿过血管系统；或具有相似或不同性能的另一材料。
可以通过其与导电线56的至少一个远端端部56a的电连接向热敏元件58供应电力。因此，操作者或控制器可以通过沿着线56向热敏元件58发送的信号来控制何时以及如何从热敏元件58发射能量。例如，当热敏元件58连接至可膨胀特征51时，控制器可以选择在可膨胀部分处于第二位置时为热敏元件58通电，并且可以选择在可膨胀部分51处于第一位置时给热敏元件58断电。
如在图5A-5C中看出的，长形构件52的可膨胀部分51可以包括定位在长形构件52的远端端部52a处的可膨胀篮状物或可膨胀笼状物80。笼状物80可以具有一个或多个支杆82，其至少基本上从笼状物80的远端端部80a延伸至笼状物80的近端端部80b。此外，笼状物80可以由例如以下材料形成：聚合物不导电材料，比如聚乙烯、聚氨基甲酸酯、聚酰胺、聚醚嵌段酰胺(PEBA)(即，PEBAXTM)、或包括具有形状记忆特性的聚合物材料和金属材料的其它材料；或具有相似或不同性能的另一材料。支杆82可以围绕长形构件52沿周向等间距地间隔开，并且围绕引导线54是同心的。替代地，支杆82可以与引导线54同心地间隔开(或以其它方式间隔开)并围绕长形构件52以任何所需间隔分离，或者可以采取另一构造。“同心地间隔开”可以被解释为第一物体(例如，每个支杆82)距基准第二物体(例如，引导线54)为相等距离。相邻支杆82之间的分离以及引导线54与支杆82之间的分离可以允许流体(例如，血液)流动穿过笼状物80并沿着血管壁冷却消融部位和/或具有其它功能。
笼状物80的支杆82可以在护套72覆盖其绝大部分(例如，笼状物80处于管腔74内并且长形构件52缩回在护套72内)时被构造在第一位置(如在图5A中看出的)，并且笼状物80和支杆82可以在护套72相对于笼状物80基本上缩回并覆盖长形轴52的非笼状物部分时定位在第二位置(如在图5B中看出的)。为了促进第一和第二位置，笼状物80的远端端部80a或近端端部80b可以在长形构件52的非笼状物部分上或上方滑动和/或相对于长形构件52的非笼状物部分滑动，并且笼状物80的相对端部可以固定至长形构件52的非笼状物部分，或者两端部80a、80b可以相对于长形构件52的非笼状物部分固定，或者两端部80a、80b可以在长形构件52的非笼状物部分上或上方滑动和/或相对于长形构件52的非笼状物部分滑动。笼状物80可以被操控以由于笼状物80的材料的特性而自动地从第一位置移动至第二位置，并且/或者笼状物80可以通过激活线56或其它线或无线通信被操作者和/或控制器操控。
邻近可膨胀部分51的热敏元件58可以定位在笼状物80的支杆82上或连接至笼状物80的支杆82。热敏元件58可以在任何位置处定位在支杆82上或连接至支杆82，其促进热敏元件58在护套72处于缩回位置时抵接或邻近孔30。例如，热敏元件58可以被设置在支杆82上或连接至支杆82，使得当支杆82处于第二位置(例如，膨胀位置)时，热敏元件58处于笼状物80的最大直径部分处或附近，如在图5B中看出的，并且/或者当笼状物80处于第二位置时，定位成远离笼状物80的最大直径部分。
如在图6A-8B中看出的，附加地或替代地，长形构件52的可膨胀部分51可以包括定位在长形构件52的远端端部52a处的气囊90。气囊90可以具有远端端部(例如，第一端部)90a和近端端部(例如，第二端部)90b，其中为了促进气囊90的膨胀，气囊90的远端端部90a或近端端部90b可以在长形构件52的非气囊部分上或上方滑动和/或相对于长形构件52的非气囊部分滑动，并且气囊90的相对端部可以固定至长形构件52的非气囊部分，或者两端部90a、90b可以相对于长形构件52的非气囊部分固定，或者两端部90a、90b可以在长形构件52的非气囊部分上或上方滑动和/或相对于长形构件52的非气囊部分滑动。气囊90相对于长形构件52的非气囊部分的这种构造可以促进气囊90在护套72覆盖其绝大部分时(例如，在气囊位于管腔74内并且长形构件52缩回时)位于第一位置(例如，基本上瘪缩)，如在图6A中看出的，并且气囊90可以在护套72相对于气囊90基本上缩回时定位在第二位置(胀大)，如在图6B-8B中看出的。
邻近可膨胀特征51的热敏元件58可以在任何位置处定位在气囊90上或连接至气囊90。例如，热敏元件58可以在促进热敏元件58在护套72处于缩回位置并且气囊90处于第二位置时抵接或邻近孔30的任何位置处定位在气囊90上或连接至气囊90，使得热敏元件58可以通过发送热能66穿过目标区域68来改变、干扰或终止肾动脉12上或附近的血管周组织的功能。例如，热敏元件58可以设置在气囊90的外部上或连接至气囊90的外部，使得当气囊90处于第二位置时，热敏元件58位于气囊90的最大直径部分处或附近，如在图6B、7A和8A中看出的，并且/或者在第二位置定位成远离气囊90的最大直径部分。替代地或附加地，热敏元件58可以定位成至少部分地处于气囊90内或气囊90的内部上，或处于其它位置或其它构造，其促进向目标区域68引导热能66。
可以采用气囊90来将热敏元件58定位在孔30处或附近，使得热敏元件58可以发送热能66至或穿过目标区域68，包括血管周组织。为了促进热敏元件58的定位，气囊90可以从气囊处于管腔74内时(例如，长形构件52相对于护套72缩回时)的第一位置膨胀至护套72缩回时的第二位置。当气囊90处于膨胀的第二位置时，如图6B-8B中那样，在第一血管60中，气囊90可以至少部分地阻挡流体从第一血管60穿过孔30流动至第二血管62。为了有助于在气囊90邻近孔30时允许流体从第一血管60流动至第二血管62，气囊90可以限定出螺旋形(或其它形状)的流动路径92，如在图7A和7B中看出的。螺旋形流动路径92可以从气囊90的近端端部90b延伸至远端端部90a，从而允许流体沿着流动路径92从第一血管60流动至第二血管62。流动路径92可以具有任何构造，例如，流动路径92可以是在气囊90处于膨胀的第二位置时位于气囊90的外表面中的盘旋形或螺旋形凹槽，如在图7A和7B中看出的。
替代地或附加地，气囊90和/或长形构件52可以包括流管94，其具有从第一端部90a(例如，远端端部)延伸穿过气囊90至第二端部90b(近端端部)的管腔96。流管94的管腔96可以被构造成与第一血管60和第二血管62流体地连通。例如，流管94可以作为导管50的一部分定位在气囊90内或相对于气囊90定位，以促进或形成流体流动路径，从而在气囊90邻近或靠近孔30处于其膨胀的第二位置时允许流体从第一血管60流动穿过管腔96至第二血管62。
如在图9A-9C中看出的，附加地或替代地，长形构件52的可膨胀部分51可以由形状记忆材料比如形状记忆聚合物或形状记忆合金形成，从而形成位于长形构件52的远端端部52a处的形状记忆和可成形部分100。当形状记忆和可成形部分100位于护套72的管腔74内(例如，长形构件52缩回到护套72中)时，部分100可以处于第一位置，如在图9A中看出的，并且当护套72相对于长形构件52缩回时，部分100可以至少部分地呈第二位置的所需形状或构造，如在图9B和9C中看出的。如果形状记忆和可成形部分100靠自己未完全呈第二位置的所需形状或位置，则控制器或操作者可以能够通过激活线56或其它线来协助进一步调节形状记忆和可成形部分100。替代地或附加地，形状记忆和可成形部分100可以具有很少(如果有的话)的形状记忆特性，并且部分100可以基本上完全通过操作者和/或通过控制器操控被设置为第二位置的所需构造，其中这类技术和所需的结构可以是本领域中公知的。形状记忆和可成形部分100相对于长形构件52的非形状记忆或非可成形形状部分的这类构造可以在护套72覆盖其绝大部分时(例如，在记忆或可成形形状部分100基本上位于管腔74内并且长形构件52缩回护套72内时)促进长形构件52位于第一位置，如在图9A中看出的，并且记忆或可成形形状部分100可以在护套72基本上缩回时定位在第二位置，如在图9B和9C中看出的。
定位成邻近可膨胀部分51的一个或多个热敏元件58可以定位在形状记忆或可成形部分100上或连接至形状记忆或可成形部分100或围绕形状记忆或可成形部分100，如图9A-9C中示出的。热敏元件58可以在促进热敏元件58在护套72处于缩回位置并且部分100处于第二位置时抵接或设置成邻近孔30的任何位置处定位在部分100上或连接至部分100，使得热敏元件58可以改变、干扰或终止肾动脉12上或附近的血管周组织的功能。例如，热敏元件58可以附接至部分100的外部，并被构造成在部分100处于第二位置时邻近目标区域68。替代地或附加地，热敏元件58可以定位成至少部分地处于形状记忆和可成形部分100内或部分100的内部上，或处于其它位置或其它构造，其促进将来自热敏元件58的热能66引导至和穿过目标区域68。
尽管已经相对于篮状物或笼状物80、气囊90和部分100描述了可膨胀部分51，但是长形构件52的可膨胀部分51可以呈除了篮状物或笼状物80、气囊90和部分100之外的各种形状、结构和构造，只要所述各种形状、结构和构造可以促进改变、干扰或终止邻近肾动脉12的血管周组织的功能即可。另外，尽管长形构件52已经被描述和图示为包括单个可膨胀部分，但是长形构件52可以包括多于一个的可膨胀部分51(例如，笼状物80、气囊90等)，其处于远端端部52a处或附近或处于沿着长形构件52的另一位置处。
如所论述的，可以采用导管50来消融、干扰、改变或破坏邻近肾动脉12的血管周组织。一种用于消融血管周组织的方法或程序可以包括：将长形轴52的远端端部52a定位在血管系统的第一血管60的管腔61中，其中近端端部52b可以基本上位于血管系统的外部。将热敏元件58定位成邻近孔30或目标区域68可以包括：使长形轴52的远端端部52a的可膨胀部分或特征51暴露和膨胀。为了暴露和膨胀可膨胀部分51，可以相对于长形构件52缩回护套72，并且可膨胀部分51可以在护套72缩回之后自动地膨胀，或者可以允许或迫使可膨胀部分51响应于操作者或控制器的信号或指示而膨胀。例如，当可膨胀部分51是笼状物80时，可膨胀部分51可以在护套72缩回时自动地开始膨胀至其第二位置。替代地或附加地，在可膨胀部分51是气囊90时的例示性示例中，一旦护套72至少部分地缩回后，在比如通过迫使气囊90膨胀的向气囊90的内部输送的充注流体使气囊90的内部接收作用力之后，可膨胀部分51可以开始膨胀至其第二位置。气囊90内的这种作用力可以由控制器和/或操作者来致动。替代地，气囊90可以在护套缩回之前接收作用力，使得气囊90由于所接收作用力而产生的膨胀使护套72相对于可膨胀部分51自动地缩回。一旦可膨胀部分51处于第二位置后，所述方法或程序可以进一步包括：通过使用第一血管60的管腔61中的热敏元件58来加热第二血管62附近的血管周组织，其中热敏元件58可以发射热能66穿过目标区域68，如在图3中看出的，或者其中热敏元件58以另一方式加热血管周组织。
一旦可膨胀部分51已经膨胀后，或者在此之前以及在加热组织之前，可膨胀部分51可以定位成邻近第一血管60与第二血管62之间的孔30。当可膨胀部分51已经定位成邻近孔30时，连接至可膨胀部分51的热敏元件58也可以定位成邻近孔30和目标区域68。在将可膨胀部分51或热敏元件58定位成邻近孔30之前、之中或之后的任何时间，可以将从近端端部52b延伸穿过长形轴52至远端端部52a的引导线54延伸穿过第一终端53a并进入第二血管62的管腔63中。
一旦热敏元件58定位成邻近孔30并且引导线54定位在管腔63内后，可以在第一血管60中的热敏元件58与第二血管62中的引导线54之间输送电(例如，热)能66，以形成双极电连接。例如，由于热敏元件58可以是消融电极并且引导线54可以是地电极，所以可以将热电能66从热敏元件58引导趋向引导线54并穿过血管60、62和血管周组织(例如，肾神经14)，来消融或改变血管周组织或用于另一目的。例如，在热敏元件58定位在第一血管60中和/或邻近孔30的情况下，电能66(例如，RF能量)可以从第一血管60和/或孔30的壁的内表面传输到血管壁中从而至神经节24或其它肾神经组织，然后回到第二血管62的管腔63中从而至引导线54。因此，这种构造可以将电能66引导至神经节24或其它肾神经组织，同时使电路径局限于孔30的区域，而不必将电路径完成到患者身体的外部。因此，电能66可以朝神经节24或神经组织的其它集中区域集中，以提高消融神经组织的效率。此外，这种构造在以下情况中可能是有益的：肾动脉12是小、短或异常的情况，或者多个肾动脉12的情况，在该情况下，将消融装置的热敏元件直接定位在肾动脉12中可能是不太有利的、不切实际的和/或不可达成的。
替代地，引导线54可以保持在第一血管60中(例如，引导线54在它保持在第一血管60中时可以不是地电极)，并且热能66可以从热敏元件58发射穿过目标区域68和血管周组织，来以电气单极方式消融或改变血管周组织。
另外，血管周组织的加热可以包括：采用多个热敏元件58来加热延伸穿过第一血管60至血管周组织的多个目标区域68。在存在多个目标区域68的场合，每个目标区域68可以被同时地加热，或者每个目标区域68可以被顺次地加热，或者每个目标区域68可以被随机地加热，或者每个目标区域68可以被单个地加热，或者每个目标区域68可以通过这些技术的组合被加热(例如，第一组的两个目标区域68可以被加热，然后第二组的目标区域68可以被加热)。此外，目标区域68中的每个可以被定位在第一血管60中的相同的或者分离的和/或不同的热敏元件58加热，其可以促进加热多个目标区域68的各种方法。
此外，尽管热敏元件58已经被描述为是通过发射电能场66来加热组织的电极或其它元件，但是一个或多个热敏元件58可以进行操作来冷却组织。例如，热敏元件58中的一个或多个可以包括用于冷却目标区域68的帕尔帖(Peltier)电极。
本领域技术人员将意识到：本公开可以被体现为除了本文中描述和想到的特定实施例之外的多种形式。因此，可以在形式和详情上发生偏差，而不背离如在所附权利要求书中描述的本公开的范围和精神。

Claims (10)

1.一种消融导管设备，用于插入患者身体的第一血管的管腔中，其中第二血管从所述第一血管伸出并与所述第一血管形成孔，所述消融导管设备包括：
长形构件，其具有带第一终端的远端端部和带第二终端的近端端部，其中所述长形构件具有从所述第一终端到所述第二终端测得的长度；
引导线，其基本上延伸所述长形构件的长度，并能穿过所述第一终端伸出；
导电线，其具有远端端部和近端端部，其中所述导电线基本上延伸所述长形构件的长度；和热敏元件，其连接至所述导电线的远端端部；
其中，所述热敏元件被构造成促进从所述第一血管内的位置消融邻近所述第二血管的血管周组织。
2.如权利要求1所述的消融导管设备，其中，所述热敏元件可定位在所述第一血管中，而所述引导线延伸到所述第二血管中。
3.如权利要求2所述的消融导管设备，其中，所述引导线是地电极，其被构造成完成从所述热敏元件穿过所述孔至所述引导线的电路径来消融邻近所述孔的神经组织，而不必完成通往患者身体的外部的电路径。
4.如权利要求1所述的消融导管设备，进一步包括：
护套，其形成管腔，所述长形构件延伸穿过该管腔；并且
其中，所述护套是可缩回的；并且
其中，所述热敏元件被暴露，并且被构造成在所述护套缩回时抵接所述第一血管与所述第二血管之间的孔。
5.如权利要求1所述的消融导管设备，进一步包括：
可膨胀特征，其定位在所述长形构件的远端端部处；和
连接至所述可膨胀特征的多个热敏元件；
其中，所述多个热敏元件被构造成围绕所述第一血管与所述第二血管之间的孔配置。
6.如权利要求5所述的消融导管设备，其中，所述可膨胀特征是可膨胀笼状物，其定位成邻近所述长形构件的远端端部，被构造成从第一位置膨胀至第二位置。
7.如权利要求5所述的消融导管设备，其中，所述可膨胀特征是气囊，其安装在所述长形构件上，被构造成从第一位置胀大至第二位置。
8.一种消融血管周组织的方法，包括：
将长形轴定位在第一血管的第一血管管腔中，其中所述长形轴包括远端端部和近端端部；以及
以定位在所述第一血管中处于所述长形轴的远端端部处的热敏元件加热邻近第二血管的目标区域处的血管周组织。
9.如权利要求8所述的方法，进一步包括：
使所述长形轴的远端端部的可膨胀部分膨胀，所述热敏元件连接至所述可膨胀部分；以及
将已膨胀的可膨胀部分定位成邻近所述第一血管与所述第二血管之间的孔。
10.如权利要求9所述的方法，进一步包括：
将延伸穿过所述长形轴的引导线定位到所述第二血管中，且所述长形轴的远端端部的可膨胀部分定位在所述第一血管中。
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US20150148797A1 (en) 2015-05-28
US11213345B2 (en) 2022-01-04
WO2013070724A1 (en) 2013-05-16
US20160324574A1 (en) 2016-11-10
US20130116687A1 (en) 2013-05-09
CN104023662A (zh) 2014-09-03
US9414885B2 (en) 2016-08-16
EP2775948A1 (en) 2014-09-17
EP3366250A1 (en) 2018-08-29
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US9844409B2 (en) 2017-12-19

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