CN110461261A - 电手术接入鞘 - Google Patents
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Abstract
一种电手术接入导管,用于帮助医生在患者的感兴趣区域(ROI)上执行辅助手术程序,该接入导管具有管状长形轴和位于远端端部处的环形作用电极。通道从轴的近端部分延伸到远端端部,并通过环形作用电极。长形轴的近端部分可拆卸地耦接到电手术控制器,使得环形作用电极可与电手术控制器和分散电极一起操作,以电手术方式制成通过组织壁的圆形切口,当环形作用电极推进通过壁时切开圆柱形组织栓塞。接入鞘通过手术产生的开口推进,而无需开口进一步扩张。本发明特别适用于肺部和微创支气管镜检查程序。还描述了相关方法。
Description
相关申请的交叉引用
本申请要求于2017年4月3日提交的且名称为“ELECTROSURGICAL ACCESS SHEATH(电手术接入鞘)”的第62/480,539号临时专利申请的优先权。
发明背景
本发明涉及手术器械,并且更具体地说,涉及具有切割肺组织的电手术功能的支气管镜接入导管(bronchoscopic access catheters)。
在各种医疗过程中,接入导管通过身体的自然内腔推进并到达进行医疗过程的目标组织部位。当手术工具从体外推进到目标部位时,接入导管用于防止对组织的附带损伤,并且在肿瘤活检和癌症治疗的情况下,随着活检样本被收集与从体内取出,接入导管潜在地防止癌细胞扩散。
接入导管必须足够大,以容纳将通过接入导管的工具。然而,容纳工具所需的接入导管的相对大的尺寸阻止接入导管在不损坏组织情况下到达更小更远的目标区。因此,需要扩张和扩展组织,以便将接入导管推进到位。需要额外的工具和仪器来安全地扩张组织间隔,并将接入导管推进到位。不希望的是,在某些情况下,可能需要多个步骤和工具更换,包括可充气气囊和扩张器械。
尽管有以上描述,一种克服上述挑战的装置和相关方法是所期望的。
发明概述
一种电手术接入鞘(access sheath)系统和方法,使得医生能够到达气道外部的患者的肺部中的目标感兴趣区域。
在实施例中,接入鞘使用射频(RF)能量产生大切口。在使用射频能量产生开口之后,接入鞘可以推进通过开口而无需扩张开口。在实施例中,射频能量是基于单极基础的。
在实施例中,通过开口的接入鞘的远端工作部分具有恒定的直径。
在实施例中,在将接入鞘放置到位之后,通过接入鞘执行各种医疗程序,包括诊断程序和治疗程序。在实施例中,对可疑的增生(growths)执行组织活检或电手术消融。
本发明的描述、目的和优点从后续的详细描述连同所附附图将变得明显。
附图简述
图1A-图1C顺序地图示了基于支气管镜的技术,用于将接入鞘从肺气道内推进到位于气道外的肺实质中的感兴趣区域。
图2是对应于图1C的代表性荧光透视影像,示出了接入鞘的位置。
图3、图4分别图示了通过接入鞘对感兴趣区域进行活检和消融程序。
图5A、图5B分别是处于缩回状态和伸出状态的电手术管心针的局部透视图。
图6是基于单极的电手术系统的图示。
图7A、图7B是电手术管心针定位并随后切割目标组织的顺序图示。
图8是包括环形电极的另一种电手术器械的局部透视图。
图9是包括环形切割电极的接入鞘的局部透视图。
图10是图9所示的接入鞘以电手术方式切割组织的图示。
图11A是用如图9所示的接入鞘产生的数个圆形切口的图示。
图11B是从图9所示的接入鞘捕获的组织栓塞的图示。
图12是电手术附接入鞘的侧视图。
图13、图14图示了制造电手术接入鞘的顺序步骤。
图15A、图15B分别是另一电手术接入鞘的局部侧视图和端视图。
图15C是图15A、图15B所示的电手术接入鞘的局部透视图。
图16是另一个电手术接入鞘的图示。
图17A、图17B是分别具有缩回状态和伸出状态的另一电手术接入鞘的图示。
图18A、图18B是另一种电手术接入鞘的图示,该鞘具有分别处于暴露状态和中立状态的切割环。
本发明详细描述
在详细描述本发明之前,应理解,由于对于描述的本发明可以进行各种改变或修改并且等同物可以被替换而不脱离本公开的精神和范围,因此本发明不限于本文所陈述的特定变型。在阅读本公开内容时对本领域技术人员来说将明显的是,本文所描述和示出的各个实施例中的每个具有离散的部件和特征,这些部件和特征可在不脱离本发明的范围或精神的情况下与其它几个实施例中的任一个的特征容易地分离或组合。此外,可以进行修改以使特定的情况、材料、物质的组成、过程、过程行动或步骤适应于本发明的目的、精神或范围。所有这样的修改旨在落入本文提出的权利要求的范围内。
本文列举的方法可以以逻辑上可能的所列举事件的任何顺序以及事件的所列举顺序来进行。此外,在值的范围被提供的情况下,应理解,在该范围的上限与下限之间的每一个中间值以及在该指定范围中的任何其他指定值或中间值都被包含在本发明内。此外,可以预期,所描述的本发明变型的任何可选择的特征可以独立地或与本文所描述的特征中的任何一个或更多个组合地被阐述并要求保护。
本文中提到的所有现有主题(例如出版物、专利、专利申请和硬件)通过引用以其整体并入本文,除了提到的现有主题可能与本发明的主题冲突以外(在这种情况下,在本文呈现的内容应优先)。
以下专利和申请通过引用以其整体并入本文:第6,692,494号、第8,709,034号、第8,784,400号、第7,393,330号和第9,265,468号美国专利以及第2013/0123638号美国专利公布。
对单个项的引用包括存在复数个相同项的可能性。更具体地,如本文和所附的权利要求中使用的,单数形式“一个(a)”、“一个(an)”、“所述(said)”和“该(the)”包括复数指示物,除非上下文清楚地另外指明。还要注意,权利要求可被设计为排除了任何可选要素。因此,此声明意图作为与详述权利要求要素有关地使用此类排他的术语诸如“唯一地(solely)”、“仅(only)”等等或使用“否定”限制的先行基础。
图1-图3顺序地示出了基于支气管镜的技术,用于在位于气道12的外部在肺实质中的感兴趣区域20上执行医疗程序。感兴趣区域20可以与气道间隔3mm-40mm的距离,并且在一些情况下,间隔10mm-15mm的距离。医疗程序的例子包括诊断和治疗类型的程序,包括但不限于活组织检查、消融、粒子植入(seed placement)和局部化学试剂输送。
首先参考图1A,支气管镜30在气道12内被示出,并且非常靠近气道壁14。接入鞘10从支气管镜30的远端端部延伸。接入鞘靠近或可能接触气道壁14。针40从接入鞘10的远端端部向感兴趣区域(ROI)20的方向推进,产生通过气道壁14的孔。
图1B示出了通过气道壁14中预先存在的孔而插入的扩张构件50。扩张构件50扩大以使孔扩展。在一些情况下,孔被扩展成比针产生的孔大2到4倍(在一些实施例中,大约3倍)。扩张构件58可以是可充气气囊、可扩展构件或另一种类型的扩张构件,例如锥形扩张器。
图1C示出了接入鞘10,接入鞘10通过气道壁14中的扩大/扩张孔推进到感兴趣区域20。标记带18在鞘上示出,以提供对鞘深度或鞘运动的视觉指示。标记带可以是墨水,并且沿鞘轴向地均匀间隔。
感兴趣区域以组织块(例如,肿瘤)示出。然而,感兴趣区域可以包括需要程序的其他组织、结构或植入物。然而,应当注意,一旦接入导管10推进到气道12之外,它就在支气管镜的视野之外。
图2示出了接入鞘的二维荧光透视影像视图。接入鞘10从支气管镜30延伸,并朝向感兴趣区域20。在荧光透视视图下看不到气道。荧光透视视图用于追踪接入鞘,并且确认器械的位置(一旦工具在气道之外,并且在支气管镜的视野之外)。
图3示出了活检钳60,活检钳60从接入鞘10的远端端部延伸。活检钳60从感兴趣区域取得样本取样。
图4示出了消融针70,消融针70从接入鞘10的远端端部延伸到感兴趣区域20中。消融针70被激活以破坏感兴趣区域。尽管示出了钳和消融针,但是范围广泛的工具可以通过接入鞘输送,以完成不同类型的医疗程序。
电手术导丝
图5A、图5B分别是处于缩回和伸出状态的电手术管心针或引导构件110的局部透视图。
管心针110包括外罩112和可相对于罩轴向地移动的内部构件120。内部构件的远端部分终止于作用电极120。作用电极可以是具有钝的边缘的丝线。在一些实施例中,丝线可以具有锋利的尖端,无论是斜面的还是其他的。在其他实施例中,丝线可以具有圆形的防损伤的球或球形尖端。
当处于图5A示出的缩回状态时,管心针100推进通过支气管镜的工作内腔,并推进到气道内腔中。外罩112防止丝线状作用电极120的尖端刺伤或损坏支气管镜或气道内腔。
作用电极120与向近端延伸的丝线导体(未示出)电连通,并耦接到电手术控制器(未示出)。此外,在实施例中,作用电极120本身可以是长形丝线的形式,并且向近端延伸到可拆卸连接器,该可拆卸连接器用于耦接到控制器。可拆卸连接器包括但不限于可移除塞入式连接器。然而,其他类型的连接器可以被包含到本文所述的系统中,以将引导构件和作用电极耦接到控制器。
内部构件120的材料可以广泛地变化。在实施例中,内部构件由金属或合金形成。用于内部构件的材料的例子包括但不限于导电材料,例如铜、不锈钢,镍钛诺和钛。
用于罩112的材料也可以变化。用于外罩材料的例子包括但不限于由PEBAX、FEP、PTFE、PE和尼龙形成的挤出聚合管。
参照图6,引导构件110从支气管镜150沿着患者132的肺部152中的气道推进到目标位置。控制器140被示出为电连接到作用电极120和附连到患者的皮肤的分散电极142。
在实施例中,交流电(例如,RF电流波形)被施加到电路,使得作用电极切割在作用电极附近的目标组织。在实施例中,频率为400kHz±100kHz的正弦电压被施加。功率设置可以在5-300瓦之间变化。切割时间也可以变化。在实施例中,能量被激活持续需要切割的时间(通常在0.1秒和5秒之间;然而,取决于解剖结构、组织含水量、盐度和类型(气道、实质、肿瘤等),切割时间会有所变化。控制器的一个例子是由美国乔治亚州马里塔市爱尔博美国公司(Erbe USA,Inc.)生产的VIO 300D。与本发明的电手术器械一起使用的电手术控制器的例子在以下文献中描述,包括但不限于第5,599,344号美国专利、第20080249523号、第20110190755号美国专利公布,这些文献中的每个均并入本文。
除了切割之外,在实施例中,控制器是可操作的以通过应用不同的能量设置来烧灼,该能量设置通常被称为控制器的凝固模式(coagulation mode)。通过封闭在切割程序中可能被切断的小血管,提供凝固模式可以增加程序的安全性。不受理论的限制,凝固通常与引起比切割模式相对较深的组织破坏的较低的温度、调制的电流和较高的电压(高达10,000V峰间值)相关联。此外,在实施例中,电手术设备被用作执行电烙术的单独产品。
图7A图示了切割组织160的图5A、图5B、图6中描述的电手术引导构件。作用电极120从罩112推进并向气道壁推进。作用电极120进一步抵靠组织表面推进,遵从组织表面。作用电极示出为沿着组织表面弯曲,使得电极120的侧面与组织160接触。
图7B示出了能量162施加到作用电极,切割组织160。
在图7B所示的实施例中,作用电极包括数个切割区域,包括横向圆周区域和前端/边缘。横向切割区的长度范围为1mm-20mm。尖端具有0.5mm的直径。
图7B的实施例中所示的多电极切割区域使得医生能够产生比仅在前边缘区域工作时产生的孔更大的孔。对应于图7B所示实施例的孔直径取决于暴露的电极长度,使用该长度所产生的孔比仅使用线尖端或仅前部烧蚀产生的孔大1至40倍。
在通过气道壁组织160产生孔、开口或通道之后,丝线120可以缩回到引导构件112中,并且引导构件组件被替换为接入鞘170。引导鞘被推进通过孔,无需将孔扩张。
在替代实施例中,引导构件组件110推进到气道壁之外,并推进通过实质组织到达ROI。荧光透视引导可用于追踪引导构件组件在气道外部的位置。
在引导构件组件到达目标位置之后,接入鞘170可以在引导构件上推进,通过预切割孔,并到达ROI(未示出)。有利地,接入鞘170可以推进到ROI,无需将孔扩张。如本文所述,可以通过接入鞘170执行各种医疗程序。
电手术引导环形电极(LOOP ELECTRODE)
图8是包括环形电极182的另一电手术引导器械180的局部透视图。环形电极示出为从外罩184突出。环182和罩184的制成材料可以与分别在图5A、5B中示出和描述的线电极构件120和罩112所用的材料相似。
环182的宽度和长度优选地分别在1mm-3mm和2mm-10mm的范围内。因此,当被激活时,环形电极可以通过气道壁进行相对较大的切割。此外,因为环形电极182自然地具有弯曲的无损伤形状,所以它可以被推进通过支气管镜和气道的工作内腔,而不会无意中结合或损坏内腔壁。
一旦产生孔,本文描述的接入鞘可以通过手术产生的孔推进到ROI。接入鞘可以推进到环形引导器械180上方的位置,或者在环形器械180被提前移除的情况下被推入到位。使用任一种技术,接入鞘推进通过孔,而无需进一步扩张或扩大孔。
此外,在实施例中,内部丝线120或环形构件182可以被配置成可从装置的近端致动。实际上,本文描述的用于切割的任何作用电极可以被配置成或连结到手柄或致动器组件,以从鞘中伸出和缩回作用电极。本文描述了用于与穿刺构件和电极一起使用的各种致动器机构。
电手术接入鞘
图9是另一接入鞘210的远端部分的局部透视图,该接入鞘210包括环形切割电极220。环形电极220从管状主体224突出。电导体、编织物与电极电接触,并向近端通过管状主体延伸到近端部分,在近端部分导体耦接到控制器。
图10图示了如本文所述当激活时,通过组织212切割开口的接入鞘210。接入鞘210被激活并推进通过组织,例如气道壁,产生接入鞘可以推进通过的端口。
此外,接入鞘被推进通过孔,而孔没有进一步扩张或扩大。在实施例中,接入鞘的外径与环形电极的外径大致相同。接入鞘的外径可以在2mm至3mm的范围内。鞘直径可以是恒定的。
如本文所述,鞘和电极的尺寸设定成容纳穿过鞘和电极的程序工具。在实施例中,电极和鞘的内径在1.8mm-2.8mm的范围内。电极和鞘可以由以上关于图5A、图5B的电极120和外罩112描述的材料制成。电极可以由铂、铱、不锈钢、钨、钛和其他导电的且x射线可见的材料制成,用于在手术过程中帮助医生定位和追踪器械。本文描述了制造鞘210的进一步的细节。
图11A是由图9中描述的接入鞘210制成的组织234中的数个孔240的图示。组织234是牛肝。切割孔的功率设置在30瓦到100瓦的范围之间。孔240被明确地限定,大的(直径约2mm),并导致获取或切开组织栓塞242。参照图11B,栓塞242的长度约为5mm的相连组织(contiguous tissue)。
预计将使用本文所述的接入鞘进行大样本活检。本文所述从牛肝取样的证据示出,样本尺寸大至长20mm,且直径2mm。在实施例中,一种方法和设备包括获取本文所述的用于微创纵隔镜检查的组织栓塞,其中非常需要大样本尺寸。此外,活检取样可以在其他淋巴部位和/或肿瘤处执行。
图12是根据本发明的一个实施例的完整的电手术接入鞘的310的侧视图。它包括柔性管状轴,该柔性管状轴具有近端部分320、中间部分330和远端部分340。如上所述,管状轴的尺寸设定成用于各种工具在其中通过,例如但不限于活检钳、抽吸针、电手术导管和冷冻消融导管、勒除器等。管状轴的内径可以在1.8mm至2.8mm的范围内,并且优选地为大约2.0mm。外径小于3mm。在图12所示的实施例中,轴的中间部分和远端部分具有恒定的外径。
不透射线的标记352以带的形式示出,该带沿鞘的远端部分均匀间隔。带352可以由各种不透射线的材料(包括例如铂、铱和其他荧光影像不透明材料)形成。
近端部分320示出为例如鲁尔(Luer)连接器,该连接器具有插座(hub)360。如上所述的某些工具可以通过鞘推进,并且方便地与插座360连接。
电缆362被示出为从近端部分延伸。电缆终止于连接器,该连接器可以与控制器(未示出)可拆卸地接合。如本文将进一步描述,在实施例中,电缆362包括导电线,导电线与鞘的远端环形电极350电连通。
接入鞘310的总长度可以变化。在实施例中,从插座360到环形电极350的长度约为35英寸-45英寸,优选地约为35英寸-40英寸。在实施例中,接入鞘310具有总长度,该总长度适合于通过患者支气管镜的工作内腔插入,超过支气管镜尖端的端部,并插入到远处或外围定位的组织增生或结节。在实施例中,结节和ROI可以位于距镜的端部3mm至100mm处、或者距气道壁3mm至100mm处的气道外的实质组织中,。
图13、图14图示了根据本发明的实施例的制造电手术接入鞘的流程400。
最初,参考步骤410,氟化乙烯-丙烯(FEP)内衬402被示出围绕聚四氟乙烯(PTFE)芯轴,该芯轴外径约2mm。编织物404被示出围绕内衬402。
编织物的节距(pitch)可以在20PPI至100PPI的范围内。此外,鞘的柔性可以通过改变编织节距(例如,紧密或松散节距、编织到线圈的过渡以及编织材料的厚度)来改变。优选的编织配置是由不锈钢制成的0.001”×0.003”扁平线的16线轴的交织结构,经纬密度为48PPI。另外,在实施例中,编织物由导电材料制成,并用作在控制器和作用电极之间的电导体。
步骤420图示了在远端端部424处将编织物404结合到内衬402。可以例如使用各种粘合剂422来进行结合。
步骤430图示了在鞘的远端端部修整编织物。
步骤440图示了将长形管状金属电极442紧固到编织物404和内衬406。管状金属电极示出为胶合到位。
步骤450图示了用绝缘体452覆盖金属电极442的近端区域,从而限定环形电极454。
绝缘体用于保护作用电极免受作用电极附近的鞘的其他部分的损坏。绝缘体的示例性材料包括但不限于聚酰亚胺、含氟聚合物、PEEK、铝氧化物(氧化铝)和聚对二甲苯。
步骤460图示了结合在编织物/内衬上的聚合物管道462。聚合物管道的示例性材料可以是PEBAX。聚合物管道462可以例如用胶结合。
步骤470图示了FEP外层472,该外层围绕聚合物管道462、绝缘体452和环形电极454。FEP外层被适当地热收缩。
步骤480图示了修整(例如,削匀)FEP层,以暴露层压聚合物管道462。
步骤490图示了修整(例如,滚切)内部FEP内衬402和多余的编织物。
步骤500示出了移除芯轴406,并完成电手术接入鞘的轴的构建。
此外,电缆(例如,图12所示的电缆362)安装到接入鞘。在实施例中,接入鞘的近端部分被削匀或修整,以暴露金属编织物的一部分。电缆在接头处联结到暴露的编织物。然后,将另一外层或电绝缘体施加到接头上,以电隔离并加强接头。
此外,从控制器通过接入鞘延伸到作用电极的电导体可以变化。在实施例中,电导体的配置是如上所述的编织物。在另一个实施例中,电导体是延伸通过管状轴并固定就位的独立绝缘电缆。在另一个实施例中,电导体是独立的轴向可移动部件(例如管心针),其通过鞘的内腔并在远端端部处与作用电极耦接。事实上,电导体可以具有多种配置。
图15A、图15B分别是另一电手术接入鞘510的局部侧视图和剖视图。电手术接入鞘510与以上关于图9描述的鞘类似。鞘包括大的远端作用电极512和大的管状轴514,管状轴514用于使工具从中推进通过。然而,电极的形状不同于图9所示的形状。图15A-图15B所示的作用电极512的横截面形状是C形。材料和制作可以与本文描述的材料和制作类似。
图15C是图15A、15B所示出的电手术接入鞘510的局部透视图。
尽管本文描述了许多特定的形状,但是作用电极的横截面形状可以变化很大。该形状可以是圆形或非圆形的。该形状可以从接入鞘的端部突出,并且仅包括前边缘和很少或没有用于切割的侧表面。电极可以采用某种程度上类似于批量生产类型的柔性金属漏版(stencil)或模具的形式,用于切割基板,例如薄气道壁。对应于刀具的不同形状的栓塞被切开,包括圆形、瞄准器形(gunsight)、星形、靶心、三角形、正方形和其他几何形状。这些形状可以形成为一组离散的狭缝或一个相连的图案。
此外,对应于交叉或垂直阴影线(hatches)的电极几何形状可以包含到基本形状中。交叉阴影线可以添加到例如圆中。阴影线可以垂直于圆并径向定向。
模具的非限制性优选特征的横向尺寸(例如,直径或长度或高度)在1.5mm-3mm的范围内。
图16示出了作用电极552,该作用电极552具有尖的或尖锐的特征562,以帮助切割并减小穿透力。图16中的作用电极552包括尖齿562。
图17A、图17B是另一电手术接入鞘610的图示,该手术接入鞘具有分别处于缩回和伸出状态的切割构件620。
图17B示出了由管心针推动器630推入组织640中的切割构件620。切割构件620被示出为围绕轴线642从缩回位置枢转到伸出位置。另外,在致动期间,推动器可以输送电波形,以使切割构件能够以电手术方式切割通过组织640。在替代实施例中,推动器配置和切割是纯机械性的。
在切割通过组织640的孔之后,鞘610可以朝向ROI(未示出)推进。随着切割构件642完全旋转出内腔650(未示出),推动器630可以用一个或更多个辅助工具交换,以在ROI上执行辅助医疗程序。
图18A、图18B是另一电手术接入鞘700的局部图示,电手术接入鞘具有分别处于暴露和中立状态的另一种类型的切割器710。
在图18A中,切割构件710被示出为裸露或暴露。它具有一个环形尖端。切割构件710可以具有例如取芯针(coring needle)的形状。
圆柱形的保护端部720示出为在长形管702中缩回或退回。
图18B图示了从切割尖端710延伸的保护端部720,该保护端部防止或中立切割动作。
切割尖端710和保护圆筒720之间的致动可以通过移动一个构件或另一个构件来实现。保护端部720可以例如通过弹簧730被偏置以延伸超过切割构件。然而,也可以采用其他致动机构,包括拉动丝线和更复杂的致动元件。
此外,切割构件和/或保护圆筒可以用作作用电极,以便于切割。
在孔产生后,辅助工具可以推进通过轴702的内腔,如本文所述。
虽然上面已经公开了多个实施例,但是应当理解,在不脱离本发明的情况下,可以对公开的实施例进行其他修改和变化。
Claims (54)
1.一种电手术接入导管,用于帮助医生在患者的肺部中的感兴趣区域(ROI)上执行辅助手术程序,所述导管包括:
管状长形轴,所述轴包括近端部分、柔性远端部分和远端端部;
环形作用电极,其位于所述远端端部处;
通道,其从所述近端部分延伸到所述远端端部并通过所述环形作用电极;和
电导体,其从所述近端部分延伸到所述远端部分,并且与所述作用电极电接触;
其中所述长形轴的所述近端部分可拆卸地耦接到电手术控制器,使得所述环形作用电极能够与所述电手术控制器和分散电极一起操作,以电手术方式制成通过气道壁的圆形切口,当所述环形作用电极推进通过所述气道壁时切开圆柱形组织栓塞。
2.根据权利要求1所述的电手术接入导管,其中所述分散电极是附连于患者的皮肤的垫。
3.根据权利要求1所述的电手术接入导管,其中所述轴包括外部聚合物层。
4.根据权利要求1所述的电手术接入导管,其中所述电导体是编织物,所述编织物同轴地布置,并且从所述轴的所述近端部分延伸到所述远端端部。
5.根据权利要求1所述的电手术接入导管,其中所述环形作用电极具有小于或等于1mm的长度。
6.根据权利要求1所述的电手术接入导管,其中所述作用电极由在荧光透视下可见的材料制成。
7.根据权利要求1所述的电手术接入导管,其中所述作用电极包括钝的远端边缘。
8.根据权利要求1所述的电手术接入导管,其中所述环形作用电极包括壁,所述壁限定管状内腔并具有至少2mm的内径。
9.根据权利要求8所述的电手术接入导管,其中所述环形作用电极包括小于3mm的外径。
10.根据权利要求1所述的电手术接入导管,其中所述作用电极是可操作的,以当以300kHz和500kHz之间的频率施加来自所述电手术控制器的正弦电压波形时切割组织。
11.根据权利要求1所述的电手术接入导管,其中所述电导体在具有选自于由可变编织节距、从编织物到线圈的过渡以及可变厚度组成的组的柔性效果的形式。
12.根据权利要求1所述的电手术接入导管,其中所述电导体是可轴向移动的并可与所述轴分离。
13.根据权利要求12所述的电手术接入导管,其中所述电导体是管心针。
14.一种电手术接入导管,用于帮助医生在患者的肺部中的感兴趣区域(ROI)上执行辅助手术程序,所述导管包括:
管状长形轴,所述轴包括近端部分、柔性远端部分和远端端部;
作用电极,其位于所述远端端部处,所述作用电极包括模具状主体,和延伸通过其中的开口;
通道,其从所述近端部分延伸到所述远端端部并通过所述作用电极;和
电导体,其从所述近端部分延伸到所述远端部分,并且与所述作用电极电接触;
其中所述长形轴的所述近端部分可拆卸地耦接到电手术控制器,使得当所述作用电极被推进通过气道壁时,所述作用电极能够与所述电手术控制器和分散电极一起操作,以电手术的方式对应于模具状主体的形状制成通过气道壁的切口。
15.根据权利要求14所述的电手术接入导管,其中所述作用电极具有c形环轮廓。
16.根据权利要求14所述的电手术接入导管,其中所述作用电极具有选自包括环形、靶心、半圆形、星形和瞄准器形的组的横截面形状。
17.根据权利要求14所述的电手术接入导管,其中所述作用电极具有小于或等于1mm的长度。
18.根据权利要求14所述的电手术接入导管,其中所述作用电极由在荧光透视下可见的材料制成。
19.根据权利要求14所述的电手术接入导管,其中,所述作用电极包括钝的远端边缘。
20.一种电手术引导组件,用于帮助医生在患者的肺部中的感兴趣区域(ROI)上执行辅助手术程序,包括:
长形引导构件,所述引导构件包括近端部分、中间部分和远端部分、以及位于所述远端部分中的作用电极;
电导体,其从所述引导构件的所述近端部分延伸到所述远端部分,并且与所述作用电极电接触;
长形柔性接入鞘,其能够在所述长形引导构件上同轴地推进;和
其中所述长形引导构件的所述近端部分可拆卸地耦接到所述电手术控制器,使得当所述作用电极被激活并推进通过气道壁时,所述作用电极能够与分散电极和所述电手术控制器一起操作,以电手术的方式制成通过所述气道壁的切口。
21.根据权利要求20所述的电手术引导组件,其中所述作用电极包括环。
22.根据权利要求21所述的电手术引导组件,其中所述环具有固定的直径。
23.根据权利要求22所述的电手术引导组件,其中所述环具有固定的形状。
24.根据权利要求20所述的电手术引导组件,其中,所述作用电极包括丝线。
25.根据权利要求24所述的电手术引导组件,其中,所述丝线包括钝的边缘。
26.根据权利要求20所述的电手术引导组件,其中所述作用电极包括可致动的丝线。
27.根据权利要求26所述的电手术引导组件,其中可致动丝线能够在轴向方向上致动。
28.根据本文所述权利要求中的任一项,其中所述切口具有小于3mm的直径。
29.根据本文所述权利要求中的任一项,其中所述作用电极用RF能量激活。
30.根据本文描述的任何一种电手术接入鞘、所述电手术接入鞘的使用方法以及电手术接入鞘的制造方法。
31.一种用于帮助医生在患者的肺部中的感兴趣区域上执行辅助手术程序的方法,所述方法包括:
将电手术引导管心针推进到肺部中的气道中,并沿着气道壁推进到目标部位;
以电手术方式激活所述引导管心针,从而产生通过所述气道壁的开口;
将所述引导管心针推进超过所述气道壁预估距离,通过实质,并到达所述ROI;
在所述引导管心针上推进接入鞘;
从所述接入鞘退回所述引导管心针。
32.根据权利要求31所述的方法,还包括通过所述接入鞘在所述ROI上执行医疗程序。
33.根据权利要求32所述的方法,其中所述医疗程序选自于由诊断程序和治疗程序组成的组。
34.根据权利要求33所述的方法,其中所述医疗程序是选自于由以下组成的组中的一种:活检、消融、切除、分碎和药物的局部输送。
35.根据权利要求31所述的方法,其中所述引导管心针包括环形电极。
36.根据权利要求35所述的方法,其中所述环具有固定的周长。
37.根据权利要求31所述的方法,其中所述引导管心针包括丝线状电极。
38.根据权利要求37所述的方法,其中所述引导管心针包括钝的边缘。
39.根据权利要求31所述的电手术引导组件,其中所述引导管心针包括可致动的丝线状电极。
40.根据权利要求31所述的方法,其中从所述气道到所述ROI的所述预估距离至少为3mm。
41.根据权利要求31所述的方法,其中所述激活步骤包括脉冲功率。
42.根据权利要求31所述的方法,还包括在计算机处理器上计算沿着预定路径的所述预估距离。
43.根据权利要求42所述的方法,其中,所述路径基于预先获取的影像数据和医生对所述影像数据中的ROI的识别。
44.一种微创手术方法,用于帮助医生在患者的肺部的感兴趣区域(ROI)执行辅助手术程序,所述方法包括:
提供接入导管,所述接入导管包括柔性近端部分和包括作用电极的远端端部,所述接入导管还包括通道,所述通道从所述近端部分延伸到所述远端端部;
推进所述接入导管的远端端部通过患者的气道并沿着气道壁到达目标部位;
激活所述作用电极,同时将所述接入导管的所述远端端部推进到所述目标部位处的气道壁中,从而产生开口并捕获圆柱形组织栓塞;
将所述接入导管的所述远端端部通过所述开口推进超过所述气道壁预估距离,通过肺实质并到达所述ROI;
排出肺部的实质中的组织栓塞;和
通过所述通道在所述ROI上执行所述辅助手术程序。
45.根据权利要求44所述的方法,其中所述医疗程序选自于由诊断程序和治疗程序组成的组。
46.根据权利要求44所述的方法,其中所述医疗程序选自于由以下组成的组中的一种:活检、消融、切除、分碎和药物的局部输送。
47.根据权利要求44所述的方法,进一步包括退回所述接入鞘,允许所述开口封闭。
48.根据权利要求44所述的方法,还包括促进所述开口的封闭。
49.根据权利要求1所述的电手术接入鞘,还包括覆盖所述作用电极的近端区域的外部层,所述外部层限定所述作用电极的远侧暴露区域。
50.根据权利要求49所述的方法,其中所述暴露区域限于所述作用电极的前边缘。
51.根据权利要求49所述的方法,其中所述外部层是绝缘体。
52.权利要求51的方法,其中所述绝缘体的材料是选自于由以下组成的组:聚酰亚胺、含氟聚合物、PEEK、铝氧化物(氧化铝)和聚对二甲苯。
53.根据权利要求44所述的方法,其中,排出所述组织栓塞是在肺部的实质中进行的。
54.根据上述权利要求中的任一项,其中所述接入鞘能够直接通过所述切口或所述开口推进,而无需扩张步骤或使用扩张部件来扩大所述切口或所述开口。
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WO2018187244A2 (en) | 2018-10-11 |
US20210106381A1 (en) | 2021-04-15 |
EP3606457A2 (en) | 2020-02-12 |
WO2018187244A3 (en) | 2019-03-07 |
EP3606457A4 (en) | 2021-04-21 |
US20240065759A1 (en) | 2024-02-29 |
US11832877B2 (en) | 2023-12-05 |
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