CN101563042A - 自动对准的消融装置及其使用方法 - Google Patents

自动对准的消融装置及其使用方法 Download PDF

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CN101563042A
CN101563042A CNA2006800522005A CN200680052200A CN101563042A CN 101563042 A CN101563042 A CN 101563042A CN A2006800522005 A CNA2006800522005 A CN A2006800522005A CN 200680052200 A CN200680052200 A CN 200680052200A CN 101563042 A CN101563042 A CN 101563042A
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longitudinal carrier
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CN101563042B (zh
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M·P·华莱士
R·加拉贝迪安
B·格伯丁
W·丘恩格
D·S·厄特利
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VNUS Medical Technologies LLC
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Abstract

本发明涉及一种消融装置及其使用方法,所述消融装置包括能够在患者消化道内支承消融结构的支架结构。所述支架结构包括旋转支架和具有纵向轴线的纵向支架。所述旋转支架能够允许消融结构的至少一部分相对于纵向支架的纵向轴线旋转。

Description

自动对准的消融装置及其使用方法
技术领域
本发明涉及一种用于消融消化道中的组织的医疗装置及其使用方法。
背景技术
人类食管的主要功能是将固态和液态营养物质从口腔输送到胃中。食管具有与生俱来的协调的收缩能力,使得物质沿着顺行方向(向着胃)蠕动。此外,食管分泌中性pH值的粘液来润滑食物通道以及保护食管内层不受由酸引起的损伤。胃包含经口腔摄入的食物和液体、来自胃内层的酸和酶、来自肝和胰腺的胆汁和酶组成的混合物。下食管括约肌和膈肌用作食管和胃的接头处的瓣,防止胃内容物反流进入食管。所述下食管括约肌通常保持闭合直至副交感神经活动或食团的到来使其松弛,以便允许食物从食管进入胃中。胃扩张尤其是胃的贲门部分扩张使下食管括约肌突然放松,导致排气现象(打嗝)。含有咖啡因或茶碱(黄嘌呤)的某些食物、药品和饮料容易导致下食管括约肌不当地松弛,并继而发生反流。与衰老或食管裂孔疝有关的解剖效应也容易导致患者产生反流。
下食管括约肌功能异常的患者可能表现出吞咽不利(吞咽困难)、反流引起的胃灼热、胸痛症状以及其它有关症状。慢性胃食管反流的常见病症是糜烂性食管炎。当长期暴露在有害的胃内容物下,食管内层可能受损,形成炎症、糜烂或溃疡。慢性胃食管返流病(GERD)和产生的糜烂性食管炎可以导致被称为巴雷特食管或肠上皮化生的癌变前期病状,巴雷特食管或肠上皮化生是上皮细胞中的与损伤有关的基因变化。
例如在2004年1月9日提交的序列号为No.10/754445的共同未决且共同所有的美国专利申请中所述,具有可扩张电极支架的治疗导管可用于治疗食管的环状区域,以便利用射频(RF)能量消融食管的异常粘膜层。如果成功,该治疗法使正常粘膜层再生,而基本上没有以巴雷特食管为特征的受到化生和其它损伤的上皮细胞。
但是,在一些情况下,这种射频消融治疗不可能完全成功并且可能留下一块或更多的异常粘膜区域。这些病灶区域可以使用设有更适合消融粘膜疾病病灶区域的表面区域的装置来处理。另外,一些巴雷特食管患者可能最初出现很有限的疾病区域,为非环形片段或非常短的片段,这可能更适合病灶消融而不是环形消融。
发明内容
在一个方面中,本发明总体上涉及消融装置及其使用方法,所述消融装置包括消融结构和能够将消融结构支承在患者消化道内的支架结构。在一种实施方式中,所述消融装置的支架结构包括旋转支架和具有纵向轴线的纵向支架。所述旋转支架能够允许消融结构的至少一部分相对于纵向支架的纵向轴线运动。
本发明的实施方式包括一个或多个以下特征。旋转支架可以适合以至少一个自由度旋转。在一种替代实施方式中,旋转支架可以适合于以至少两个自由度旋转。在另一种替代实施方式中,旋转支架可以适合于以至少三个自由度旋转。
旋转支架可以包括能够限制转动范围的止动构件。旋转支架可以包括运动阻件(move resistor)。在一种实施方式中,所述运动阻件包括弹簧。在另一种实施方式中,旋转支架包括适于防止消融结构转动的锁止件。
在一种实施方式中,消融装置包括适于防止消融结构转动的致动机构。
支架结构可以包括内窥镜。作为替代方式,支架结构可包括导管。
消融结构可以包括至少一个电极。在一种实施方式中,可以通过支架结构支承多个消融结构。在另一种实施方式中,消融结构能够对组织进行低温消融。
在另一方面中,本发明总体涉及在消化道中消融组织的方法,所述方法包括以下步骤:将消融结构推进到消化道内;用支架结构将消融结构支承在消化道内;将消融结构的至少一部分从支架结构转动离开并向着组织表面旋转;以及激活消融结构,以便对组织表面进行消融。
本发明的实施方式包括消融组织的方法,其中旋转步骤包括在消融结构和组织表面之间施加力。在另一种实施方式中,推进消融结构的步骤包括推进多个消融结构,旋转步骤包括通过在多个消融结构中的一个或多个与组织表面之间施加力来旋转多个消融结构中的一个或多个的至少一部分。
旋转步骤可以包括围绕至少一条旋转轴线旋转消融结构的至少一部分。在一种实施方式中,旋转步骤包括围绕至少两条旋转轴线旋转消融结构的至少一部分。在另一种实施方式中,旋转步骤包括围绕至少三条旋转轴线旋转消融结构的至少一部分。
在一种实施方式中,消融组织的方法还包括限制消融结构的转动范围。在另一种实施方式中,所述方法还包括在旋转消融结构的同时阻止消融结构的旋转。在一种附加实施方式中,所述方法还包括锁定消融结构以防止消融结构旋转。
推进消融结构的步骤可以包括将内窥镜推进到消化道内。在一种实施方式中,支承步骤包括用内窥镜支承消融结构。
在一种实施方式中,消融结构包括至少一个电极,并且激活步骤包括给电极提供电能。在另一种实施方式中,消融结构具有低温消融的能力,并且激活步骤包括将过冷流体供应到消融结构。
附图说明
本发明的新颖性特征特别是在附带的权利要求书中提出。通过参照以下给出了示例性实施方式的详细描述和附图可以更好地理解本发明的特征和优点,在这些实施方式中使用了本发明的原理,其中:
图1是包括示出了运动自由度的坐标轴的本发明的消融装置的视图。
图2A是包括旋转支架和示出了运动自由度的坐标轴的支架结构的剖视图。
图2B是包括另一种旋转支架和示出了运动自由度的坐标轴的支架结构的剖视图。
图2C是包括又一种旋转支架和示出了运动自由度的坐标轴的又一种支架结构的视图。
图2D是包括另一种旋转支架的另一种支架结构的视图。
图2E是包括又一种旋转支架和示出了运动自由度的坐标轴的又一种支架结构的视图。
图3A是本发明的消融装置的视图。
图3B是另一种旋转支架的视图。
图3C是另一种替代的旋转支架的视图。
图4A是在消化道环境中与内窥镜结合的本发明消融装置的视图。
图4B是本发明消融装置的视图,所述消融装置包括与内窥镜结合的唇片特征部和电极挽绳(electrode trace)。
图4C是本发明消融装置的视图,所述消融装置包括与内窥镜结合的唇片特征部、端口和管线。
图5是本发明的消融装置与内窥镜结合的视图,所述消融装置包括支架结构和两个消融结构,所述支架结构具有两个旋转支架和两个纵向支架。
图6是本发明的包括运动阻件的消融装置的视图。
图7A和7B是本发明的包括另一种运动阻件的消融装置的视图。
图8A和8B是本发明的包括又一种运动阻件的消融装置的视图。
图9A和9B是本发明的包括另一种运动阻件的消融装置的视图。
图10是本发明的包括另一种运动阻件的消融装置的视图。
图11A、11B和11C是本发明的包括一种替代的运动阻件的消融装置的视图。
图12是本发明的包括致动机构的消融装置的视图。
图13是本发明的连接到内窥镜上的消融装置的视图。
图14A和14B是消融装置的替代实施方式的视图。
图14C是如图14A和14B所示的消融装置的端视图。
具体实施方式
本发明提供了一种装置和方法,其使用包括支架结构的消融装置在患者或受检对象的消化道内消融组织,所述支架结构能够在消化道内支承消融结构。消融装置的支架结构包括旋转支架和具有纵向轴线的纵向支架。旋转支架适合允许至少一部分消融结构相对于纵向支架的纵向轴线旋转。根据本发明,消融装置被推进到消化道中。可选的是,消融装置可以支承在内窥镜的远端上。消融结构可以向着组织表面旋转地偏转,并且可以激活消融结构以消融组织表面。在消化道内,可以使用本文所述器械和方法有选择地消融各种尺寸的组织表面部位。
就本发明公开的目的而言,由粘膜和肌肉组成的、在口腔和肛门之间延伸的、起消化和排泻功能的任何部分都被认为是消化道的一部分。这些部分包括但不限于食管、胃、小肠、阑尾、大肠、结肠、直肠和肛管。
如图1所示,本发明的消融装置100总体上包括能够支承消融结构130的支架结构111。旋转支架116上支撑有带有纵向轴线并且支承消融结构130的纵向支架114。旋转支架116能够允许至少一部分纵向支架114相对于其纵向轴线旋转,以便允许至少一部分消融结构130旋转。旋转支架允许纵向支架114转动,所述转动包括但不限于例如旋转、枢转、翻转或回转。可以想到的是,纵向支架114可以从支架114的纵向轴线旋转开、或向着所述纵向轴线或绕所述纵向轴线旋转。
图1还以x、y和z坐标轴显示出纵向支架114,旋转支架116可以允许纵向支架114以多个可能的自由度运动。虽然在图1和后续图中只用单向箭头示出了围绕每条轴线的可能旋转,但是旨在表示围绕给定轴线的双向旋转。
如图1和2A所示,可将旋转支架116构造和布置成使得纵向支架114能够以三个自由度自由旋转。所述三个自由度标示在三条轴线x、y和z上。在附图中标有“是”的轴线表示能够围绕该轴线双向自由运动,而标有“否”的轴线表示不能围绕该轴线自由运动。可以想到的是,旋转支架可以适合以至少一个自由度、至少两个自由度、或至少三个自由度旋转。还可以想到的是,可以将消融装置构造和布置成为纵向支架提供沿着x、y或z平面(没有显示)的线性运动或浮动。例如,海绵或顺应性纵向支架可以允许沿着y方向的线性压缩(没有显示)。
如图2B至2E所示,可以将旋转支架116构造和布置成使得纵向支架114能够以两个自由度自由旋转。在图2B和2D的实施方式中,纵向支架能围绕x和y轴自由旋转但是不能围绕z轴自由旋转(见图2B所示的坐标轴和图2D所示的x和y轴)。在图2C和2E所示的实施方式中,纵向支架能够围绕x和z轴但是不能围绕y轴自由旋转。
如图5所示,支架结构111可以包括联接到两个纵向支架114上的单个旋转支架116,每个纵向支架114支承一个消融结构130。纵向支架114和底座112可以由顺应性材料(包括但不限于硅酮或聚氨酯)制成。可以想到的是,消融装置100可替代地包括联接到一个或多个旋转支架116上的两个或多个纵向支架114。
如图1、2A、2B、2D、2E、3A至3C、4A、4B、5、6、7A、7B、8A、8B、9A、9B、10、11A至11C、12和14A至14C所示,旋转支架还可以包括底座112部分。如下详细描述的,通常将底座112构造和布置成用于将消融装置100固定或连接到细长构件上的部件,所述细长构件包括但不限于例如内窥镜或导管。
可以将旋转支架116的一部分构造和布置成包括用于将旋转支架116连接到纵向支架114上并且为纵向支架114提供旋转运动的多种形状和结构中的任何形状和结构。可能的形状包括但不限于例如圆形、球形、等直径圆柱形、变直径圆柱形和椭圆球形。可能的结构包括但不限于例如一个或多个铰链、弹簧、万向接头、球形接头或关节接头。
如图1、2A、4B和5所示,在一种实施方式中,旋转支架116可以包括能够插入纵向支架114的凹槽或接收件例如插座中的球形部分。在另一种实施方式中,如图2B所示,旋转支架116可以包括具有凸起117特征的球形部分。在该实施方式中,凸起117与纵向支架114的槽115特征接合,由此允许纵向支架14沿着两条轴线x和y轴旋转,但不允许沿着z轴旋转。凸起117与纵向支架的槽115的接合防止了纵向支架114围绕z轴的旋转。
如图2C所示,在另一种实施方式中,旋转支架116可以包括细长球形或橄榄球形部分。如图中坐标轴所示,图2C中所示的实施方式被构造和布置成允许纵向支架114(没有显示)相对于两条轴线旋转。如所示,纵向支架114(没有显示)可以沿着x和z轴旋转但不能沿着y轴旋转。
如图2D所示,在另一种实施方式中,支架结构111可以包括具有销119和旋转支架116的万向接头。如所示,该实施方式允许纵向支架114(没有显示)围绕x和y轴旋转。可以想到的是,支架结构111可以包括两个或更多个万向接头。如图2E所示,在另一种实施方式中,旋转支架116可以包括弹簧。如所示出的坐标轴标示的,该实施方式允许纵向支架114围绕x和z轴旋转但是不能围绕y轴旋转。
如图3A至3C和14A至14C所示,在另一种实施方式中,支架结构111可以包括具有销119的结构。可以想到的是,销119可以穿过支架结构111的纵向支架114的一部分、旋转支架116、并且在一些情形中穿过底座112(或底座112的连接元件120),由此连接纵向支架114和旋转支架116。通过纵向支架114围绕销119的旋转提供纵向支架114的至少一部分相对于其纵向轴线的旋转。可以想到的是,一个或多个万向接头可以与一个或多个销119结合使用,以便为纵向支架(没有显示)提供旋转运动。
如图14A和14B所示,其中支架结构111包括销119,纵向支架114围绕销119的旋转可以包括纵向支架114从零点位置(见图14A)到成角度或倾斜位置(见图14B)的运动范围。零点位置和倾斜位置对于组织表面的处理都很有用。包括薄轮廓的零点位置对于引入消融装置100和/或从处理部位移除消融装置100特别有用。
如图3B所示,在另一种实施方式中,旋转支架116除了包括销119之外还包括联接到销119上的弹簧124(例如扭簧)。如图3C所示,在又一种实施方式中,旋转支架116除了包括销119还包括联接到销119上的运动阻件123。在该实施方式中,运动阻件123可以由任何抵抗性(resistive)或顺应性物质或结构制成,所述物质或结构能够在销119偏转或旋转一段时间之后将销回复到期望的位置。适当的结构包括但不限于套筒或衬套,例如硅酮套筒或衬套。用于包覆或粘接销的适当材料包括但不限于硅酮、氨基甲酸乙脂或其它聚合物材料。其它适当的材料和结构为本领域技术人员所熟知。
可以想到的是,支架结构可以包括本文所述的旋转支架116特征的任何组合。
旋转支架的底座可以被构造和布置成以各种方式支承消融装置。在一些实施方式中,底座被构造和布置成将消融装置的支架结构连接到另一装置例如传统的胃窥镜上。例如,底座可以被构造和布置成将消融装置连接到内窥镜的外表面上。替代方式是,底座可以被构造和布置成将消融装置连接到内窥镜的内表面、外部或内部特征元件或以上的任何组合上。在一些实施方式中,如图1、3B至3C、4A和4B、6、7A和7B、8A和8B、9A和9B、10、11A和11B以及12所示,底座112被构造和布置成护套。在一种特别实施方式中,底座112包括弹性护套。在其它实施方式中,如图3A和14A至14C所示,底座112包括连接元件120以及箍或带126。在一种实施方式中,带126为弹性带。连接元件120可以在底座112和纵向支架114之间提供连接点。带126可以连接到连接元件120上并且用于例如连接内窥镜。如果需要,连接元件120和带126可以由相同或不同材料制成。如图14A至14C所示,连接元件120可以包括与纵向支架114成一定角度的斜的或倾斜部分。如图所示,在一种实施方式中,连接元件120的倾斜部分被设置在底座112的连接元件120上的销119对面。连接元件120的倾斜部分可以起到能够使消融装置100更容易取出的功能。
如图4B和4C所示,在一种实施方式中,旋转支架的底座112包括挡块或唇片113特征。唇片113可以被构造和布置成起挡块的作用,用于协助相对于辅助装置(例如所示的内窥镜127)对消融装置100进行定位。在如图4B至4C所示的示例中,可以通过唇片113来限制内窥镜127在旋转支架116的底座112内的定位。唇片113可以相对于内窥镜远端128指引或限制消融装置100的远侧/近侧位置。
通常,在一方面,消融装置100包括如图6、7A和7B、8A和8B、9A和9B、10、11A至11C以及12所示的运动阻件123。通常,运动阻件123被构造和布置成被动地控制纵向支架114的旋转运动。运动阻件123的优点包括缩小消融装置100的轮廓。缩小轮廓在进入受检对象的期望处理区域和/或从患者的期望处理区域取出消融装置100时是很有用的。例如,缩小轮廓的消融装置100可以使消融装置100在进入消化道1或从消化道1取出时几乎不会或不会被绊住或被挂住。因为纵向支架114通常能够以一个或多个自由度自由运动,运动阻件123可以有利地起到控制运动自由的作用。在一些实施方式中,运动阻件123包括联接或连接到纵向支架114上的弹性或超弹性结构。在其它实施方式中,运动阻件123包括各种其它机械部件,以便控制纵向支架114的旋转运动。
如图6所示,在一种实施方式中,运动阻件123包括弹簧。可以想到的是,弹簧可以是悬臂弹簧(如图6所示)、板簧、扭簧或本领域技术人员所知的任何弹簧类型。在一种实施方式中,如图6所示,悬臂弹簧形式的运动阻件123可以被构造和布置成限制纵向支架114相对于连接的内窥镜127的远端128的旋转运动。如所示,纵向支架114通常通过运动阻件123的弹簧保持在零点位置中。如本文中所用,“零点位置”意味着纵向支架114的纵向轴线基本上平行于连接到消融装置100上的内窥镜127或其它细长构件的纵向轴线。在一种实施方式中,运动阻件123连接到旋转支架底座上,或者底座的连接元件或带上。使得运动阻件123将预紧力施加到纵向支架上,迫使消融装置被锁定在相对于连接的内窥镜127(没有显示)的最低轮廓位置中。
运动阻件可以被构造和布置成抵抗纵向支架的旋转运动,并且依然允许纵向支架由于力的作用而从零点位置旋转偏离。在没有这样的力时,运动阻件的一些实施方式易于使纵向支架回复到零点位置。可以想到的是,运动阻件可以被构造和布置成影响纵向支架围绕一条或多条运动轴线的旋转运动。此外,可以想到的是,不同的运动轴线(例如x,y和z轴;见图1)受运动阻件的影响可以不同。
在一种实施方式中,如图7A和7B所示,运动阻件123可以包括包封导电线133的护套。所述护套可以由弹性或超弹性材料制成,弹性或超弹性材料包括但不限于例如硅酮。如图7B所示,护套式运动阻件123连接在纵向支架114的一端上。护套式运动阻件123的另一端能够通过例如套筒138(见图7A和7B)相对于内窥镜127或其它细长结构固定就位。在如图7A和7B所示的实施方式中,导电线133可以包括Z形图案。所述图案允许导电线133在运动阻件123拉伸时变长。
如图8A和8B所示,在另一种实施方式中,运动阻件123可以包括与纵向支架114联接或被连接到纵向支架上的弹性或超弹性材料带。适当的弹性或超弹性材料可以包括但不限于硅酮。如图8A所示,在一种实施方式中,运动阻件为套在纵向支架114的一部分上并且将其与内窥镜127连接在一起的弹性或超弹性材料的带。如图8B所示,在一种实施方式中,运动阻件123是将纵向支架114的一部分与内窥镜127连接的弹性或超弹性材料的带。在如图8B所示的示例中,所述带通过连接到内窥镜127上的套筒138连接到内窥镜127上。
在另一种实施方式中,如图9A和9B所示,运动阻件123可以包括连接到纵向支架114的一部分上的拉条或系绳。所述拉条或系绳的一部分可以通过安装在内窥镜127上的套筒138连接到内窥镜127上。当连接到消融装置100上的内窥镜127的远端128被布置成相对直的构型时,该实施方式的运动阻件123通常可以将纵向支架114保持在零点位置中。当内窥镜远端128如图9B所示偏转时,运动阻件123的拉条或系绳可以松弛或聚集在一起。在一种实施方式中,运动阻件123的拉条或系绳被构造和布置成在松弛时以手风琴的方式折叠(见图9B)。
在另一种实施方式中,如图10所示,运动阻件123可以包括指形件121部分和凹槽122部分。指形件121可以通过套筒138或其它连接部件连接到内窥镜127上,并且凹槽122可以包括在纵向支架114中。如图10所示,当连接到消融装置100上的内窥镜127的远端128被布置成相对直的构型时,指形件121可以与凹槽122接合,由此将纵向支架114保持在零点位置中。可以构造和布置指形件121和凹槽122,使得内窥镜远端128的偏转或将力施加到纵向支架114的部分上能够将指形件121从凹槽122可逆地释放。一旦指形件121被释放,纵向支架114就能自由地进行旋转运动。指形件121和凹槽122的重新连接再次将纵向支架114保持在零点位置中。
如图11A至11C所示,在一种实施方式中,运动阻件123为连接到部分纵向支架114的一部分上的裙板或裙裾,所述裙板或裙裾沿着被连接的内窥镜127的长度向近侧延伸。在该实施方式中,运动阻件123的裙板或裙裾装配在纵向支架114的近端上或与支架114的近端并置。该布置为纵向支架114的近侧部分提供了平滑轮廓。由于减少了支架114绊住或挂住组织表面的风险,这样的轮廓便于从处理区域取出消融装置100。运动阻件123可以如图11A所示连接到纵向支架114上或如图11B所示连接到纵向支架114上,或者作为变换方式不被连接。
可以想到的是,在单个消融装置中可以包括上述运动阻件的一个或多个,以便控制纵向支架的旋转运动。也可以想到的是,除了套筒连接之外,运动阻件的一部分与内窥镜、导管或其它结构的连接可以包括多种连接方式的任何连接方式。例如,运动阻件可以连接到内窥镜或导管或其元件(没有显示)的内侧或外侧表面上。
在一个方面中,消融装置100通常包括致动机构134,用于主动地控制纵向支架114的旋转(例如见图12)。通常,致动机构134允许在使纵向支架114受旋转约束和使支架114自由旋转之间相互转换。如图12所示,在一种实施方式中,致动机构134包括开关135以及拉条(或系绳)136。致动机构134的开关135可以联接到内窥镜127上,内窥镜127被连接到消融装置100上。拉条136可以联接到纵向支架114的一部分上。在如图12所示的实施方式中,致动机构134的开关135通过套筒138连接到内窥镜上并且可以定位在包括标示的位置“A”和“B”的一个或多个位置中。将致动机构134切换到位置“A”使得拉条136被拉紧并由此限制纵向支架114的旋转自由。而且,当在位置“A”中时,支架114被保持在零点位置中。如果将致动机构134切换到位置“B”,那么拉条136对纵向支架114的拉紧被释放,由此允许纵向支架114作旋转运动。
在另一种实施方式中,致动机构包括真空管线(没有显示)。在该实施方式中,纵向支架的旋转运动通过真空管线提供的抽吸力来控制,所述真空管线被构造和布置成使得当施加真空时纵向支架的近端部分固定不动。在没有真空时,纵向支架可以自由旋转。
在另一种实施方式中,致动机构被构造和布置成使得纵向支架的旋转运动受电磁体(没有显示)控制。在该实施方式中,施加电磁力导致纵向支架被固定在零点位置中。因此,当不再施加电磁力时,所述纵向支架能够自由旋转。
在一种实施方式中,消融装置为电极结构,所述电极结构被构造和布置成将包括射频能量的能量传递到消化道组织上。可以想到的是,这样的消融结构可以包括多个电极。例如,两个或更多个电极可以是消融结构的一部分。能量可以以适当量级传递以完成粘膜或粘膜下层组织的消融,或者换句话说使这些组织受损伤,同时基本保留肌肉组织。本文中所用的术语“消融”指的是引起组织或细胞坏死的组织热损伤。热损伤可以通过对组织加热或冷却(例如冷冻)实现。通常,在本发明这些实施方式中,消融用于将处理区域中的整个粘膜内层包括异常粘膜(例如异常柱状增生)从受影响的食管部分去除并且允许正常粘膜内层再生。有利的是,当使用这种方法时,治疗更加快速并且组织中狭窄的形成被减至最低。同样,电极消融元件可以允许流体(例如盐水)渗透通过纵向支架和/或电极,以防止组织在消融过程中粘附到电极上。
虽然射频能量是用于消融的能量的一种有利形式,但是应当理解的是,其它有利的能量形式包括例如微波能量或者光子源或辐射源(比如红外或紫外光),光子源或辐射源可以结合改进的敏化剂。光子源可以包括半导体发射源、激光源和其他源。也应当理解,本发明的另一种实施方式可以使用可加热流体或冷却介质例如液氮、氟利昂
Figure A20068005220000151
非氟氯化碳(CFC)制冷剂或二氧化碳作为消融能量介质。为了使用热或冷流体或气体来消融,可以设想,消融系统可能需要一种用于将热/冷介质从患者体外循环到热/冷囊或其它元件然后再回到患者体外的装置。用于在低温外科探头中循环介质的装置在消融领域众所周知。例如,授予Dobak,III的专利号为No.6182666的美国专利、授予Li的专利号为No.6237355的美国专利和授予Kovalcheck等人的专利号为No.6572610的美国专利披露了适当的循环装置,以上专利通过引用结合入本文。
消融结构可以包括设置在消融结构上的电极双极阵列,所述电极双极阵列能够以双极形式传输射频能量。作为变换方式,消融结构可以包括单极电极结构,该单极电极结构可以通过射频电源与返回电极结合来供能,所述返回电极通常设置在患者皮肤(例如在腰背部)上。在任一情况下,射频能量在非常短的时间内以高能通量传输,从而仅仅损伤或消融粘膜组织或粘膜下层组织,而基本上不会加热或损伤肌肉组织。其中消融结构包括多个电极、一个或多个电极可以是双极或单极的。也可以是双极和单极电极的组合。
如图1A、3A、4A、5、6以及7A和7B所示,消融结构130的形状和尺寸可以以任何方式构造和布置。如图3A、4A、7A、7B和14A至14C所示,消融结构130可以包括电极阵列132。如果消融结构130包括电极阵列132,那么通常电极阵列的面积在大致0.5cm2到9.0cm2的范围内。典型的阵列形状可以包括正方形、矩形、圆形或椭圆形。在一种实施方式中,消融结构130的面积为2.5cm2。在另一种实施方式中,消融结构130的尺寸为2cm×2cm、面积为4cm2
纵向支架被构造和布置成用于支承消融结构。支架114可以由能承受消融结构130产生的高能通量的任何适当材料制成。纵向支架可以是柔性的,能够围绕两条轴线旋转,由此还允许纵向支架旋转离开纵向轴线(没有显示)。在一种实施方式中,纵向支架由弹性材料(例如硅酮)制成。其它适当的材料包括氨基甲酸乙脂或其它聚合物材料。
如图3A、4A、4B、7A、7B和14A至14C所示,消融装置100还可以具有包括导线133的电连接件,以便将消融结构130连接到电源上。导线133可以如需要的那样包括单根线或多根线,以通过消融结构提供受控能量传输。在一种实施方式中,导线133包括低电损耗线例如李兹(litz)线。如图4A和4B所示,导线133可以缠绕或拉到纵向支架114的远端上并且从支架114下方穿过。通过防止对旋转运动的束缚或限制,这种布置有利地易化了纵向支架114的旋转运动。
如图4A、4B和14A至14C所示,消融装置100还可以包括一条或多条电极挽绳131。所述一条或多条电极挽绳131可以被构造和布置成与至少一部分纵向支架114相一致。所述一条或多条电极挽绳131可以与电极132和导线133形成电连接。可以设想到的是,挽绳131可以是电极132的延伸部分或者是单独元件。如图14A至14C所示,所述一条或多条挽绳131可以通过接头140特征与导线133形成电连接。如图所示,接头140可以连接到底座112的连接元件120上。可以设想到的是,导线133能够通过接头140可拆卸地连接到消融装置上,其中接头被构造和布置成例如电连接件。
也应当理解,本发明的另一种实施方式可以使用可加热流体或冷却介质例如液氮、氟利昂非氟氯化碳(CFC)制冷剂或二氧化碳作为消融能量介质。为了使用热或冷流体或气体来消融,可以设想到的是,消融系统可能需要一种用于将热/冷介质从患者体外循环到热/冷囊或其它元件然后再回到患者体外的装置。用于在低温外科探头中循环介质的装置在消融领域众所周知。例如,授予Dobak,III的专利号为No.6182666的美国专利、授予Dobak,III等人的专利号为No.6193644的美国专利、授予Li的专利号为No.6237355的美国专利和授予Kovalcheck等人的专利号为No.6572610的美国专利披露了适当的循环装置,以上专利通过引用结合入本文。
因此,在另一种实施方式中,如图4C所示,消融结构130可以被构造和布置成用于组织的低温消融。通常,通过提供用于输送冷却流体的导管或支架,纵向支架114可以支承或充当消融结构130,以便实现组织的低温消融。在一种实施方式中,消融结构可以是能够填充有流体或气体(没有显示)的囊或囊形结构。在另一种实施方式中,消融结构包括覆盖纵向支架的一部分或整个表面的膜盒或箱形元件,所述膜盒或箱形元件可以填充有流体或气体(没有显示)。在另一种实施方式中,纵向支架为部分或完全中空,用于容纳流体或气体。可以设想到的是,消融结构或纵向支架可以包括导热材料,用于促进热量传递以便实现组织的低温消融。还可以设想到的是,消融结构或纵向支架可以包括覆盖其整个或部分表面的导热元件。例如,适当的导热元件可以是薄金属表面,包括但不限于不锈钢或钛。
可以设想到的是,在一些实施方式中,消融结构或纵向支架可以被构造或布置成可被加热剂或冷却剂(没有显示)渗透。同样,还可以设想到的是,所述加热剂或冷却剂可以滤过消融结构或纵向支架,由此允许加热剂或冷却剂与组织表面直接接触。
如图4C所示,冷却流体到消融结构130的输送装置可以包括一条或多条管线144和可选的一个或多个端口142。管线144可以被构造和布置成输送流体(包括过冷流体)。端口142可以在管线144和消融结构130之间提供连接。端口142可以直接地联接到纵向支架114上。在一种实施方式中,端口联接到纵向支架上并且提供到消融结构的管线,所述消融结构与支架(没有显示)相连。作为变换方式,端口142可以直接联接到消融结构(没有显示)上。在一些实施方式中,管线144通过端口142连接到纵向支架114上(见图4C)。端口可以包括有利于通过获得压力差产生气态或液态相变的喷嘴或其它特征。
举例来说,如图4C所示,一种实施方式包括联接到端口142上的两条管线144。管线144都沿着连接的内窥镜127的长度延伸(在图4C所示的视图中只可见一条管线144沿着内窥镜127的长度延伸)。端口142直接连接到纵向支架114的底侧上,并且纵向支架114的上表面起消融结构130的作用。纵向支架114可以基本中空,以允许介质例如加热流体或冷却流体进入。
可选的是,所述装置的管线提供了用于流体流动到消融结构和从消融结构流出的回路。例如如图4C所示,在一种采用了两条管线144和两个端口142的实施方式中,一条管线144可以用作输入管线,而另一条管线可以用作输出管线。
在使用中,加热的或过冷流体可以通过输入管线输送至消融结构,由此激活消融结构。使用过冷流体激活消融结构可以包括引发液体至气体的相变,或着通过产生压力差例如压力降(理想气体定律:PV=nRT)来引发相变。组织的低温消融可以通过使组织与过冷消融结构接触来实现。可选的是,可以通过使加热的或过冷流体介质连续或断续流入消融结构和从流出管线流出而保持加热流体或过冷流体介质在消融结构中的连续流动。如果需要,在消融后可以将所述介质从消融结构去除。可选的是,在去除过冷介质之后,可以将具有期望温度的另一种流体、气体或空气引入消融结构中。
通常,在另一方面中,在消化道1中消融组织的方法包括将包含消融结构130(在此为电极132)的消融装置100推进到消化道1中(见例如图4A)。消融结构130在消化道1内受到支架结构111的支承。至少一部分消融结构130可以从支架结构111旋转离开并且指向组织表面5。消融结构130可以如期望地那样被激活,以便消融组织表面5。
如图4A所示,在一种实施方式中,旋转至少一部分消融结构130(在此显示为电极132)包括在消融结构130(例如电极132)和组织表面5之间施加力。在另一种实施方式中,其中消融装置100包括多个消融结构130(见例如图5),旋转步骤包括在一个或多个消融结构130和组织表面5之间施加力。
在消化道中消融组织的方法还包括围绕至少一条旋转轴线和/或围绕至少两条旋转轴线和/或围绕至少三条旋转轴线旋转至少一部分消融结构。如上详细所述,消融装置可以被构造和布置成支持这样的运动。例如如图1所示,消融装置100的支架结构111可以包括纵向支架114和旋转支架116。消融结构130受到纵向支架114的支承,同时旋转支架116能够允许至少一部分消融结构130旋转。以上详细描述了与本发明方法的消融结构130的旋转运动有关的各种结构。
在另一种实施方式中,旋转至少一部分消融结构的方法包括限制消融结构的旋转范围。以上描述了与限制围绕x、y和z轴旋转范围有关的特征的各种结构。例如,公开了各种旋转支架,其提供了相对于x、y和z轴的运动自由度。
在另一种实施方式中,所述方法包括在旋转消融结构的同时抵抗消融结构的旋转运动。如上所述,消融装置可以包括各种运动阻件结构特征,所述运动阻件结构特征被构造和布置成抵抗消融结构的旋转运动。例如,公开了对纵向支架以及消融结构的旋转运动的控制的运动阻件。
在一种实施方式中,如图4A所示,推进消融结构130的步骤包括将内窥镜127推进到消化道1中。一种市场上能买到的传统内窥镜127的示例是型号为GIF-Q160的奥林巴斯“胃内窥镜(gastrovideoscope)”。虽然尤其是能在市场上买到的内窥镜的具体结构是不同的,但是如图13所示,绝大多数内窥镜包括轴164,该轴164具有可控远端128和集线器或手柄162,所述集线器或手柄162包括用于连接到显示屏160上的视频通道161和提供访问轴164内的内部工作通道的端口166。电源159可以通过电缆165将能量提供给内窥镜127。正如内窥镜领域中常见的那样,刻度盘、杠杆或其它机构(没有显示)通常被设置在手柄162上以便操作者有选择地控制内窥镜127的远端110。在使用中,其中消融装置100联接或连接到内窥镜127上,可以将所述组合引入到消化道中并且在消化道内推进。在一种变换实施方式中,推进消融结构的步骤包括将导管推进到消化道中(没有显示)。
如图4A所示,在一种实施方式中,所述方法包括使用内窥镜127支承消融结构(显示为电极132)。在使用中,如图4A所示,包括消融结构(显示为电极132)的消融装置100可以连接到内窥镜远端128上用于支承消融装置。如上具体所述,在一些实施方式中,旋转支架116还包括底座112,所述底座112被构造和布置成将消融装置100连接到内窥镜127上。同样,底座112可以提供连接点,用于通过内窥镜127来支承消融装置100。
在另一种方法中,将包括消融结构的消融装置推进到消化道中的步骤包括将内窥镜推进到消化道中并且在内窥镜上推进消融装置。例如,可以相对于消融目标组织定位内窥镜,随后可以在内窥镜的外侧上推进消融装置以便消融目标组织。
在另一种方法中,支承消融装置的步骤可以包括在将消融装置推进到消化道中之后将内窥镜插入到消融装置中。如2005年11月23日提交的共同未决的美国专利申请Nos.11/286257和11/286444中具体公开的那样,各种变型和构造的消融装置可以装配在内窥镜内部工作通道并且在其中输送通过,所述专利申请的所有公开内容通过引用结合入本文。同样,作为变换方式,消融装置的消融结构可以通过内窥镜的内部工作通道来支承。可以设想到的是,本文所述的用于支承消融装置的方法的任何组合都是可能的。
在本发明的另一种方法中,其中消融结构是至少一个电极,激活消融结构的步骤可以包括通过电连接件将电能提供给电极(见例如3A、4A、4B、7A、7B和14A至14C)。
虽然本文中显示和描述了本发明的优选实施方式,但是对于本领域技术人员而言显然只是示意性的。在不脱离本发明的情况下,本领域技术人员会想到大量变型、变化和替换。应当理解的是在实施本发明的过程中可以采用本文所述的本发明实施方式的各种变换形式。旨在用下面的权利要求限定本发明的范围,由此覆盖在所述权利要求的范围内的方法和结构及其等同物。

Claims (13)

1.一种消融装置,包括:
消融结构;和
支架结构,其能够在患者消化道内支承所述消融结构,所述支架结构包括旋转支架和具有纵向轴线的纵向支架,所述旋转支架能够允许所述消融结构的至少一部分相对于所述纵向支架的纵向轴线运动,所述旋转支架包括运动阻件。
2.如权利要求1所述的装置,其中,所述旋转支架能够以至少一个自由度旋转。
3.如权利要求1所述的装置,其中,所述旋转支架能够以至少两个自由度旋转。
4.如权利要求1所述的装置,其中,所述旋转支架能够以至少三个自由度旋转。
5.如权利要求1所述的装置,其中,所述旋转支架还包括能够限制转动范围的挡块构件。
6.如权利要求1所述的装置,其中,所述运动阻件包括弹簧。
7.如权利要求1所述的装置,其中,所述运动阻件包括能够防止所述消融结构作旋转运动的锁止件。
8.如权利要求1所述的装置,还包括能够防止所述消融结构作旋转运动的致动机构。
9.如权利要求1所述的装置,其中,所述支架结构包括内窥镜。
10.如权利要求1所述的装置,其中,所述支架结构包括导管。
11.如权利要求1所述的装置,其中,所述消融结构包括至少一个电极。
12.如权利要求1所述的装置,还包括由所述支架结构支承的多个消融结构。
13.如权利要求1所述的装置,其中,所述消融结构能够对组织进行低温消融。
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JP5227183B2 (ja) 2013-07-03
EP1968471A4 (en) 2010-07-28
KR20080091149A (ko) 2008-10-09
AU2006338555A1 (en) 2007-08-30
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US20140243817A1 (en) 2014-08-28
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US9918793B2 (en) 2018-03-20
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AU2006338555B2 (en) 2013-01-10
MX2008008123A (es) 2008-09-08
BRPI0620168B8 (pt) 2021-06-22
US20070118104A1 (en) 2007-05-24
US20140243818A1 (en) 2014-08-28
US20090177194A1 (en) 2009-07-09
US8702694B2 (en) 2014-04-22
US8702695B2 (en) 2014-04-22
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US9918794B2 (en) 2018-03-20
CA2633687C (en) 2016-03-22

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