CN106456243B - 与具有筛网电极的电外科棒相关的***和方法*** - Google Patents
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Abstract
一种用于在患者的身体内或身体上的目标位置处治疗组织的电外科棒被描述,其包括具有手柄和远端部分的细长轴。该远端部分具有有源电极、绝缘的间隔件主体以及返回电极;该有源电极由绝缘的间隔件主体支承并且与返回电极隔开。有源电极具有侧向和中间边缘表面。绝缘的间隔件主体具有与抽吸管腔流体连接的抽吸空腔以及至少一个锥形孔,该至少一个锥形孔延伸超出电极中间边缘表面的至少一个并且指向抽吸空腔。
Description
与申请相关的交叉引用
无。
技术领域
本发明一般涉及电外科领域,并且更特别地涉及用于施加高频电压以消融组织的设备和方法。更特别地,本发明涉及用于将基本上平坦的筛网型有源电极固定至电外科仪器的轴的远端末端的设备和方法以及流体抽吸的方法。
背景技术
电外科***被医生用以在外科手术期间执行特定功能。例如,在消融模式中电外科***使用高频电能以去除软组织,诸如窦组织、脂肪组织或其他组织,诸如关节中的半月板、软骨或滑膜组织。
常规的电外科方法被广泛地使用,因为它们通常实现了止血并且减小了与组织切割操作相关的患者出血,同时改进了治疗区域的外科医生的视野。在电外科中使用的许多电外科装置包括从该区域去除流体、碎屑和气泡的方法,以便改进在目标组织区域周围的临床医生的视野。然而,在一些电外科装置的情况中(在这里需要足够的流体以实现某些临床效果,诸如消融),需要在最佳位置平衡流体去除或以流体去除为目标。这可以允许足够的流体用于蒸气层或等离子体生成,同时最小化该区域中的碎屑和气泡。许多装置也利用筛网型有源电极,该筛网型有源电极典型地从导电材料的薄片中切割或刻蚀得到。然而,这些电外科装置和方法可能承受许多缺点。例如,筛网型有源电极典型地要求固定至绝缘主体并且进一步固定至装置自身的远端末端的一些方法。无法将筛网电极充分固定至绝缘主体可以导致不正常的装置功能。
将筛网有源电极固定至绝缘主体的在先尝试已经包括机械、热和化学方式及其各种组合。已经采用多种机械固定形式,同时已经使用粘合剂作为连接的化学形式,并且焊接该筛网可以提供连接的热方法。这些机械连接方法还可以包括使用被用于固定的材料的塑性、或非可恢复性形变。然而,即使与其他连接方法组合,但由于热老化和等离子体老化,用于固定的所有方法提供典型地在延长使用周期上受到挑战的解决方案。因此,必须结合具有这些老化方法的筛网电极固定的最佳定位。
因此,期望允许相对于消融表面或边缘的定向流体抽吸的装置和方法。额外地,期望用于将平坦的筛网有源电极固定至电外科仪器的绝缘主体、同时维持通过该绝缘主体的电连接的装置。特别地,期望用于提供将电连接的筛网有源电极持久地固定至电外科装置的远端末端处的绝缘主体、同时提供增强的电外科操作参数的机械方法。
发明内容
本发明提供用于在最小地阻断蒸气层的情况下从外科手术区域和外科医生的观察区域抽吸流体、碎屑和气泡的***、设备和方法。本公开内容还提供用于将筛网型有源电极机械地固定至在电外科装置的远端末端处的绝缘主体的***、设备和方法。另外,本公开内容提供用于利用内部的尖锐几何结构形成高电流密度以在筛网电极上减速磨损的***和设备。
在本发明的一个方面中,本公开内容描述了用于使用输送至患者身体内或身体上的目标位置的高频电压来治疗组织的电外科棒。该棒包括具有手柄端部和远端部分的细长轴,远端部分具有电极组件和绝缘的间隔件主体。电极组件包括基本上平坦的有源筛网电极以及与该有源筛网电极隔开的返回电极。返回电极可以与有源筛网电极靠近地隔开并且可以是细长轴的一部分。有源电极意在接触组织并且具有相对大的组织接触表面和周界或边缘表面。绝缘的间隔件主体接触在位置中的组织,并且还作用以支承并电绝缘有源筛网电极。抽吸空腔布置在间隔件主体内,其在组织接触表面处具有由有源筛网电极部分地覆盖的细长开口,同时部分细长空腔开口延伸超出部分筛网电极边缘表面。组织接触表面包括具有第一孔周界的第一抽吸孔,部分第一孔周界由筛网电极的部分边缘表面限定并且还由部分抽吸空腔限定。
根据本公开内容的电外科装置的另一个结构是用于在外科手术位置处治疗组织的电外科棒,其具有细长的壳体,限定了手柄端部以及在远端处的组织接触表面。部分组织接触表面包括布置在绝缘的间隔件上的有源筛网电极,这个间隔件还构成部分组织接触表面。有源筛网电极包括至少一个侧向边缘表面,不含任何凹凸部,诸如可以产生高电流密度区域(诸如,尖锐特征或粗化表面)的表面几何结构或纹理,以及诸如具有至少一个凹凸部(诸如一个尖锐几何结构特征)或较高电流密度的区域的远端和近端边缘表面的中间表面。组织接触表面还包括在与至少一个侧向边缘表面隔开的分离位置处的第一抽吸孔以便不破坏靠近侧向边缘表面的任何等离子体或蒸气层。这个孔与布置在棒内的抽吸管腔流体连通并且可以从外科手术位置去除任何碎屑或气泡。这个第一孔具有包括部分绝缘的间隔件空腔以及包括部分电极远端边缘表面或电极近端边缘表面的周界。
在本公开内容的另一个方面中,使用电外科棒治疗目标组织的方法被描述,该方法包括在目标组织附近放置棒的远端部分,该远端部分包括由绝缘的间隔件支承的基本上平坦的有源筛网电极。然后可以在有源电极和与该有源电极隔开的返回电极之间施加高频电压,该高频电压足以在有源电极的组织接触表面附近产生蒸气层。然后可以定向该远端部分使得有源电极的侧向边缘表面在目标组织附近以便主要地使用该边缘表面治疗目标组织。然后可以通过至少一个抽吸孔来抽吸组织碎片和气泡,该至少一个抽吸孔位于与侧向边缘表面隔开的分离区域中。这样以便不破坏靠近有源电极侧向边缘表面的蒸气层,因此以维持侧向边缘表面附近的均匀的蒸气层,以便形成更加一致的电外科组织效果。至少一个抽吸孔具有由有源筛网电极构成的其周界的一部分以及由间隔件抽吸空腔构成的一部分。
附图说明
为了详细描述示例性实施例,现在将参考附图,其中:
图1示出根据至少一些实施例的电外科***;
图2示出根据至少一些实施例的电外科棒;
图3a示出根据至少一些实施例的棒远端的透视图;
图3b示出根据至少一些实施例的棒接触表面的视图;
图3c示出根据至少一些实施例的棒远端横截面视图;
图4示出根据至少一些实施例的棒的绝缘间隔件的透视图;
图5示出根据至少一些实施例的治疗组织的棒的远端的立视图;
图6示出根据至少一些实施例的治疗组织的方法;以及
图7示出根据至少一些实施例的治疗组织的方法。
符号和命名
在整个下列说明书和权利要求书中使用某些术语来表示特定的***部件。如本领域技术人员将了解的,设计和制造电外科***的公司可能用不同的名字来来表示一个部件。本文件不旨在区分名字不同但是功能相同的部件。
在下列讨论和权利要求书中,以开放式的方式使用术语“包括”和“包括”,并且因此应该理解为“包括但不限于……”的意思。而且,术语“联接”或“联接”旨在意为间接连接或直接连接。因此,如果第一装置联接至第二装置,该连接可以是通过直接连接或者通过经由其他装置和连接的间接连接。
涉及单数形式物件包括存在复数个相同物件的可能性。更具体地,当在本文和所附权利要求书中使用时,单数形式"一个"、"一个"、"所述"和“该”包括复数引用,除非上下文另外明确指示。另外要注意的是,可以将权利要求书撰写为排除任何可选元件。如此一来,这种陈述用作使用与要求保护元件的陈述有关的排他性术语(诸如"单独地"、"仅仅"等)或者使用"否定"限制的先行基础。最后,要理解的是,除非另有限定,在本文中使用的所有技术和科学术语的意义与本发明所述领域的普通技术人员通常所理解的意义相同。
"有源电极"应意指在与作为治疗目标的组织接触或紧邻于作为治疗目标的组织时产生电诱导组织改变效果的电外科棒的电极,和/或具有由电压发生器在其上引发的电压的电极。
“返回电极”应意指相对于有源电极用于为电子提供电流流动路径的电外科棒的电极,和/或自身不对以治疗为目标的组织产生电诱导组织改变效果的电外科棒的电极。
当提供数值范围时,应该理解的是,在该范围的上限值和下限值之间的每个***值以及在该陈述范围中的任意其他所述值或***值都包括在本发明内。而且,可预期的是,可以独立于或结合在本文中所描述的任意一个或多个特征来阐述并要求保护所描述的发明性变型的任意可选特征。
在本文中提及的所有现有主题(例如,公开文献、专利、专利申请和硬件)通过引用的方式整体并入本文中,除非该主题可能与本发明的主题相冲突(在冲突的情况下,应以本文中所提出的为准)。引用的物件仅被提供用于在本申请的申请日之前的公开内容。本文中没有任 何内容被解释为许可本发明无权借助于在先发明而将此类材料的日期提前。
具体实施方式
本发明提供用于选择性地将电能施加至患者的身体内或身体上的目标位置的***和方法。本发明在用导电流体淹没或浸没组织部位的手术中是特别有效的,诸如膝盖、肩部、踝部、臀部、肘部、手部或足部的关节镜手术。在其他手术中,本发明对于用于单独治疗目标组织或与组织的体积移除结合的手术中的胶原收缩、消融和/或止血是有效的。更具体地,在本文中描述的实施例提供电外科装置,其特征在于置于装置的远端末端处的基本上平坦并且相对较薄的筛网有源电极。额外地,本实施例包括用于从外科手术区域定向抽吸流体和碎屑的设备和方法,以及将筛网电极和耐磨损设计特征机械地固定至该筛网电极的方法。这些实施例可以通过提供对等离子体更耐磨损的电极以及更牢固的附接电极的固定方法来延长电外科装置的操作周期。这些实施例还可以改进外科手术区域的外科医生的视野,同时最小化对筛网电极周围的蒸气层的任何破坏并且因此最小化对预期的组织效果的任何破坏。
在详细描述本发明之前,要理解的是,本发明不限于在本文中所阐述的特定变型,因为在不脱离本发明的精神和范围的情况下,可以作出多种改变和修改,并且可以用等同物替代。如本领域技术人员在阅读本公开内容时将了解的,在本文中所描述和图示的每个单独实施例具有分立组件和特征,在不脱离本发明的范围或精神下其可以容易地与其他多个实施例的任何特征分离或组合。此外,可以作出许多修改以使特定情形、材料、物质组成、过程、(多个)过程行为或(多个)步骤适应本发明的目标、精神或范围。所有这些修改意在处于本文中所作出的权利要求的范围内。
可以按所述事件的逻辑上可能的任意顺序以及事件的所述顺序来执行在本文中所述的方法。另外,当提供数值范围时,要理解的是,在该范围的上限值和下限值之间的每个***值以及在该所述范围中的任何其他所述值或***值被包括在本发明内。而且,可期望的是,可以独立于或结合在本文中所描述的任意一个或多个特征来阐述并要求保护所描述的发明性变型的任意可选特征。
在本文中提及的所有现有主题(例如,公开文献、专利、专利申请和硬件)通过引用的方式整体并入本文中,除非该主题可能与本发明的主题相冲突(在冲突的情况下,应以本文中所提出的为准)。引用的物件仅被提供用于在本申请的申请日之前的公开内容。本文中没有任 何内容被解释为许可本发明无权借助于在先发明而将此类材料的日期提前。
涉及单数形式物件包括存在复数个相同物件的可能性。更具体地,当在本文和所附权利要求书中使用时,单数形式"一个"、"一个"、"所述"和“该”包括复数引用,除非上下文另外明确指示。另外要注意的是,可以将权利要求书撰写为排除任何可选元件。如此一来,这种陈述用作使用与要求保护元件的陈述有关的排他性术语(诸如"单独地"、"仅仅"等)或者使用"否定"限制的先行基础。最后,要理解的是,除非另有限定,在本文中使用的所有技术和科学术语的意义与本发明所述领域的普通技术人员通常所理解的意义相同。
图1图示根据至少一些实施例的电外科***100。特别地,电外科***100包括联接至电外科控制器104(下文称作“控制器104”)的电外科棒102(下文称作“棒102”)。棒102包括限定远端108的细长的壳体或细长的轴106。细长的轴106进一步限定手柄或近端110,在外科手术期间医生在该处握持棒102。棒102进一步包括容纳一个或多个电导线(图1中未具体示出)的柔性多导体线缆112,并且柔性多导体线缆112以棒连接器114为终端。如图1中所示,棒102诸如通过在外壳122的外表面(在图1的示意性情形中为正面表面)上的控制器连接器120而联接至控制器104。
尽管在图1的视图中不可见,在一些实施例中,棒102具有联接至外部可访问的管状构件的一个或多个内部流体导管。如图示,棒102具有柔性的管状构件116,用于在棒的远端部分108处提供抽吸。根据各个实施例,管状构件116联接至蠕动泵118,该泵与控制器104作为整体部件被说明性地示出。在其他实施例中,用于蠕动泵118的外壳可以与用于控制器104的外壳122分离(如附图中的虚线所示),但是在任何情况中,蠕动泵可操作地联接至控制器104。在各个实施例的情境中,在棒102的远端部分处,蠕动泵118从外科手术区域创建体积受控的抽吸。
仍然参考图1,通过控制器104的外壳122的显示装置或接口装置130是可见的,并且在一些实施例中,用户可以通过接口装置130和相关的按钮132来选择控制器104的操作模式。在一些实施例中,电外科***100还包括足部踏板组件134。足部踏板组件134可以包括一个或多个踏板装置136和138、柔性多导体线缆140以及踏板连接器142。虽然仅示出两个踏板装置136和138,但是可以实施一个或多个踏板装置。控制器104的外壳122可以包括联接至踏板连接器142的对应连接器144。医生可以使用足部踏板组件134以控制控制器104的各个方面,诸如操作模式。例如,踏板装置136可以用于将射频(RF)能量施加至棒102的开关控制。另外,踏板装置138可以用于控制和/或设置电外科***的消融模式。在某些实施例中,可以通过选择性地按压位于棒102的手柄110上的手指按钮(没有具体地示出手指按钮以免附图过于复杂)来启动控制器104的各种操作或性能方面的控制。
各个实施例的电外科***100可以具有多种操作模式。一种这样的模式采用Coblation®技术。特别地,本公开内容的受让人是Coblation®技术的拥有者。Coblation®技术涉及在棒102的一个或多个有源电极和一个或多个返回电极之间施加RF能量以在目标组织附近产生高的电场强度。该电场强度可足以在一个或多个有源电极和目标组织之间的区域中、在至少部分一个或多个有源电极上气化导电流体。该导电流体可以固有地存在于身体中,诸如血液,或者在一些情形中是细胞外或细胞内的流体。在其他实施例中,导电流体可以是液体或气体,诸如等渗盐水。在一些实施例中,导电流体由棒102在有源电极附近被输送和/或被输送至目标位置。
当导电流体被加热至流体的原子蒸发比原子凝聚更快的点时,形成蒸气或气体。当向蒸气或气体施加足够的能量时,原子相互碰撞,在此过程中引起电子的释放,并且形成电离气体、电离蒸气层或等离子体(所谓的“物质的第四状态”)。换句话说,可以通过驱动电流通过气体或者通过将电磁波引入气体中来加热该气体并电离该气体从而形成等离子体。等离子体形成的方法将能量直接赋予等离子体中的自由电子,电子-原子碰撞释放更多电子,并且该过程级联直至实现期望的电离度。等离子体的更完整的描述能够在普林斯顿大学的等离子体物理实验室的R.J.Goldston和P.H.Rutherford的等离子体物理(1995)中找到,其全部公开内容通过引用结合在本文中。
随着等离子体的密度变得足够低(即,对于水溶液小于近似1020原子/立方厘米),电子平均自由路径增加,使得随后注入的电子在等离子体内引起撞击电离。当等离子体层中的离子微粒具有足够的能量(例如,3.5电子伏特(eV)至5 eV)时,离子微粒与构成目标组织的分子的撞击使目标组织的分子键断裂,使分子分离成自由基,然后该自由基组合成气态或液态物质。通常,等离子体中的电子携带电流或者吸收电磁波,并且因此比离子微粒更热。因此,从目标组织带走朝向有源电极或返回电极的电子携带等离子体的大部分热量,使得离子微粒能够以基本上非热的方式使目标组织分子断裂分开。
借助于分子分离(与热蒸发或碳化相反),通过较大的有机分子的分子分离成较小的分子和/或原子(诸如氢气、氧气、碳的氧化物、碳氢和氮化合物)而在体积上移除目标组织。分子分离完全地移除组织结构,其与通过移除组织细胞内的液体和细胞外的流体来使组织材料脱水(如在相关技术的电外科分离和蒸发中所发生的)相反。分子分离的更详细描述能够在共同转让的美国专利No.5,697,882中找到,其全部公开内容通过引用结合在本文中。
除了Coblation®模式之外,当用在已知的凝结模式中时,图1的电外科***100对于密封较大的动脉血管(例如,在约1毫米直径的量级上)也是有效的。因此,图1的***可以具有消融模式,其中处于第一电压下的RF能量被施加至一个或多个有源电极,其足以影响组织的分子分离或分解,并且图1的***还可以具有凝结模式,其中处于第二、较低电压下的RF能量被施加至一个或多个有源电极(与消融模式相同或不同的电极),其足以加热、收缩、密封、熔合和/或实现组织内割断的血管的止血。
可以通过调节多种因素来改变在棒102的远端108处由电外科***100产生的能量密度,该多种因素诸如:有源电极的数目;电极大小和间距;电极表面积;电极表面上的凹凸部和/或锋利边缘;电极材料;施加的电压;一个或多个电极的电流限制(例如,通过与电极串联布置电感器);与电极接触的流体的导电率;导电流体的密度;以及其他因素。因此,能够操纵这些因素以控制受激电子的能量等级。
图2示出根据示例***的棒102的视图。在图示的实施例中,细长轴106由金属材料(例如,TP304级不锈钢皮下注射管)制成,并且在一些情形中,细长轴106还限定用于***的返回电极。诸如图2中所示的实施例的棒102可以被设计用于涉及膝盖或臀部的外科手术。该图示的实施例的细长轴106具有圆形的横截面形状,其朝向远端108具有弯曲部分,这使得远端108相对于轴106的近端部分的细长轴线以近似40º定向。额外地,远端表面被定向成与轴106的细长轴线成一角度,相对于轴106的远端以近似30º切割,以限定椭圆形的远端表面250(其在图3a和图3b中更清楚地图示)。这提供较低的棒远端轮廓,从而适应空间限制和之后的解剖进入。对于其中细长轴106的横截面形状是圆形的实施例而言,外侧直径可以在约3毫米(mm)的量级上,但是可以使用更大和更小的尺寸。
在其中细长轴是金属的实施例中,如图3a中图示的,远端部分108可以进一步包括联接至细长轴106的电绝缘间隔件200。在一些情形中,间隔件200是陶瓷的,但是可以等效地使用当暴露于等离子体时耐老化的其他非导电材料(例如,玻璃)。间隔件200可以以任何合适的方式联接至细长轴106,诸如在细长轴106的内径内伸缩,通过在细长轴106之上伸缩,和/或通过使用粘合剂。如在图3c中所示,间隔件200具有可操作以放置在细长壳体106的内径内的伸缩部分266,并且在一些情形中,间隔件可以至少部分地由粘合剂保持就位。间隔件200支承由金属或导电材料构造的至少一个有源筛网电极202。因此间隔件200将有源电极202与细长轴106电绝缘,因为细长轴106可以作用为返回电极203。在一些实施例中,仅部分细长轴106被露出以作用为返回电极203,而轴106的其余部分由绝缘材料覆盖。
图示的有源筛网电极202可以包括导电材料,诸如钨、钛、钼、不锈钢、铝、金、铜等。筛网电极202可以具有在约0.5至8 mm范围内的直径,优选地约1至4 mm,以及约0.05至约2.5 mm的厚度,优选地约0.1至0.5 mm。筛网电极202可以具有多种不同形状,诸如图3a和图3b中所示的形状,包括至少一个侧向边缘表面205,其具有不含任何凹凸部(诸如,尖锐的几何结构)的连续的边缘表面。侧向边缘表面205与所有抽吸孔侧向隔开,诸如在棒102上更中间地布置的孔206、254和252,使得蒸气层可以邻近侧向边缘表面205形成并且可以在任何抽吸期间保持相对地不受破坏。筛网电极202还可以包括中间边缘表面,诸如远端边缘表面210和近端边缘表面212,其至少一个可以包括至少一个凹凸部,诸如内部的尖锐几何结构特征或尖端214a、214b,或者尖锐的或边缘表面几何结构的一些形式。诸如内部的尖锐几何结构特征的表面凹凸部形成较高的电流密度的点,其导致在有源电极202上的蒸气层起始的优选点以及潜在的等离子体生成。没有尖端214a、214b,蒸气层起始可能要求更高的电压。在图3a和图3b中最清楚地图示,有源电极202具有布置在远端边缘表面210上的不同大小的四个反向的尖端214a以及布置在近端边缘表面212上的不同大小的另外四个反向的尖端214b。这些尖端被布置在有利于增强蒸气层形成和潜在地随后的等离子体形成的特定的、不同的位置处,但是与侧向边缘表面205中间地隔开。
特别地,反向的尖端214a、214b可以由在点230处切向地相交的弯曲部分209限定。反向的尖端214a、214b在整个有源电极202的厚度上具有一致或均匀的形状,使得相交的点230形成细长的表面或直线穿过筛网电极202的厚度,其在相邻的弯曲部分209之间具有最小的过渡或半径。反向的尖端214a、214b形成蒸气层起始的点,以改进蒸气层形成和潜在地等离子体形成,其靠近相交的点230用于平滑的组织切割。不同于本领域中已知的其他等离子体和蒸气层起始凹凸部,诸如向外突出的点或者替代地电极的边缘或拐角,反向的尖端提供在组织治疗期间、在棒和电极横跨组织表面运动期间最小化组织清除障碍(snagging)的蒸气层起始点。额外地,使用如由交点230形成的反向的尖端214a、214b看上去提供了有源电极202材料磨损和侵蚀的更加一致且可预测的模式的意想不到的益处。在图3b中最清楚地图示,反向的尖端214a和214b具有多种深度和曲线,使得点230可以与电极远端边缘表面210或近端边缘表面212以不同的程度隔开。在典型的棒操作期间已经发现,远端表面210相对于近端表面212趋于优先腐蚀。其一个原因是在组织治疗期间的典型的棒定向的结果,这导致在电极202的更远端部分处的优选的蒸气层起始。发明人也已经发现,在这个特定的定向中,吸入抽吸孔中的流体的流速在电极202的远端部分处以及当吸入至孔252中时更高。已经发现电极202的材料的腐蚀速率与尖端至更高的流体抽吸区域的接近程度直接相关。因此,相对于具有第二深度D或者较大的深度D的尖端214b,邻近于具有相对较高的流体流速的抽吸孔(例如,在当前描述的构造中的邻近孔252)的远端尖端214a具有第一或减小的深度(d)以适应这些不同的腐蚀速率。通过在靠近优选的蒸气层起始特性和更高的流体抽吸速率的区域中调节尖端的深度,发明人已经发现可以延长电极202的使用寿命。
筛网电极202可以包括抽吸孔206,抽吸孔206具有可以取决于特定应用而改变的大小和构造。典型地,电极抽吸孔206将足够大以允许消融的组织碎片经过进入绝缘间隔件200内的抽吸空腔和吸入管腔(在后续附图中描述)以及柔性管状构件116中。电极抽吸孔206大致地布置在有源电极202的中心处并且与至少一个侧向边缘表面205隔开。此处所示,抽吸孔206在两个侧向边缘表面205之间近似地等距隔开。筛网电极202还可以具有至少一个固定导线孔216,其被设计成用于容纳固定导线或带状物220的大小,该固定导线或带状物220可操作以将有源筛网电极202固定至间隔件200。导线或带状物220可以包括导电材料,诸如铂铱,并且可操作以执行多个功能。首先,固定导线220与布置在细长轴106以及有源筛网电极202内的线缆112电连接,以便构成电导管的一部分,RF控制器104通过该电导管输送能量至有源筛网电极202。固定带状物220可以通过至少一个固定导线孔216突出(如图3b中所示)并且被处理以便提供与有源电极202的持久的电接触和机械固定(如图3a中的焊接形式221所示)。该处理可以包括激光点焊。固定导线220优选地由具有比有源筛网电极材料更低的熔化温度的材料构造,以便在激光点焊期间容易地熔化,而不影响有源电极202的晶粒结构。有源电极202的结构改变可以降低在使用期间对等离子体老化的耐性。固定导线220还必须包括具有自身基本上耐等离子体老化的材料,使得激光点焊以及因此机械固定和电连续性随着使用最小程度地老化。
筛网电极202具有露出的组织接触表面204,以及邻接间隔件顶部表面250的内表面(此处未示出)。部分间隔件顶部表面250还形成部分组织接触表面。筛网电极202以最小的间隙邻接间隔件顶部表面250,阻止流体进入和能量误导向。在一些实施例中,诸如在图3a中所示,有源电极202限定露出的侧向边缘表面205没有任何凹凸部或内部的尖锐几何结构214a、214b以允许用于在某些更敏感的组织类型(诸如软骨)上的应用的侧面消融效果。使用侧向边缘表面205还允许电极表面204和相关联的组织效果的最大可见性。如在图3c中所示(图3b的截面A-A)有源电极孔206经由间隔件抽吸空腔256流体联接至柔性管状构件116(在图3c中所示)。
如在图3b、图3c和图4中最清楚地图示,间隔件空腔256限定在间隔件顶部表面250处的细长形状的开口。间隔件空腔256与电极孔206流体连通,并且在近端和远端方向上延伸超出有源电极202的近端边缘表面212和远端边缘表面210,以便限定远端孔252和近端孔254。间隔件空腔256从顶部表面250处的细长开口渐细至间隔件200内的近似圆形的横截面255,这赋予空腔256细长漏斗状的形状。空腔渐细可以具有在约140º-170º范围内的角度,并且优选地如在图3c中所示的相对于接触表面204约为157º的角度。这个角度限定在有源电极内表面218与抽吸导管的圆形横截面255的起点之间的最大间隙X,以便最小化由于较大的碎屑尺寸而导致的抽吸管道和导管的堵塞。间隙X可以在约0.1至1 mm的范围内,优选地约0.3-0.6 mm。尺寸上大于间隙X的碎屑或组织碎片将变为陷在间隙X内并且由靠近有源电极内表面218的消融效果继续***成碎片,直至碎屑或组织碎片尺寸减小,自由地被抽吸通过横截面255,同时不太可能堵塞任何下游的抽吸导管或管腔,诸如管腔116。
间隔件空腔256经由孔252、254并且相应地与筛网电极远端和近端边缘表面210和212配合限定邻近于或处于电极接触表面204的多个抽吸孔,所有这些抽吸孔在间隔件200的空腔256内流体连接。远端孔252具有由电极远端边缘表面210部分地限定以及由间隔件空腔256的远端部分部分地限定的连续周界。如在图3b中所示,该周界还包括至少一个内部尖端214a。近端孔254具有由包括至少一个尖端214b的电极近端边缘表面212部分地限定以及由空腔256的近端部分部分地限定的周界。近端孔254延伸超过有源电极近端边缘212第一距离“E”,同时远端孔252延伸超过有源电极远端边缘210第二距离“e”。为了在远端孔252和近端孔254之间具有更平衡的流,已经发现延伸量“E”应该大于延伸量“e”。这是由于在两个孔(252和254)之间的不同的抽吸速率,该不同的抽吸速率主要地作为过渡角260和262的差异的结果。参见图3c,能够看到的是,过渡角260相对于过渡角262限定较窄的角度,并且导致优选地通过远端孔252抽吸碎屑。增加的抽吸可以引起邻近增加抽吸区域的优先的电极腐蚀,所以近端孔254因此比远端孔252相对较大以便更好地平衡横跨组织接触表面204的抽吸流,并且以减轻对于每个孔周围的有源电极202的任意特定部分的潜在腐蚀。
间隔件孔252和254以及电极孔206为从围绕有源电极202的区域待抽吸的流体和气泡提供导管。在关节镜手术期间,手术位置附近(即,有源电极附近)的视场可能被气泡遮挡。也就是说,如上所述的经由与蒸气层组织接触的消融过程产生气泡,并且在许多情形中,这些气泡被快速抽吸走以便对视场没有不利影响。然而,过于接近正在治疗目标组织的有源电极202的部分的过度抽吸可能阻断蒸气层以及因此阻断消融组织效果的均匀性。因此孔206、252和254以分离位置的方式与侧向边缘表面205隔开。孔206、252和254布置在侧面边缘表面205和主要的外科手术区域观察端口之间,以便有效地去除主要在侧向边缘表面205处产生、随后自然地朝向孔206、252和254上升的气泡。这被认为改进外科手术区域的外科手术的可见性,同时最小地影响侧向边缘表面205附近的蒸气层。
在图4中示出根据一些实施例的间隔件的详细透视图,以更好地描述间隔件空腔256和固定导线导管258。间隔件空腔256可以在间隔件200内形成细长的漏斗形式或空腔,其在间隔件200的较近端位置处渐细至较圆的横截面255(参见图3c),以便与布置在细长轴内的流体管道116(图3c中所示)对接。固定导线导管258在横截面上可以是均匀的并且在轴向上延伸通过间隔件200的整个厚度以允许用于固定导线220的通路通过间隔件200。由电绝缘材料制成的间隔件200可以使固定导线220(在图3b中所示)与彼此以及与返回电极203电隔离。在替代实施例中,固定导线220可以具有电绝缘涂层。固定导线220近端地延伸通过轴106并且可以与手柄110内的多导体线缆112电联接(此处未示出)。
图5更详细地示意性图示通过使用根据本公开内容的电外科棒102的实施例的目标组织300的典型治疗。初始地,外科医生可以将间隔件侧面240放置在组织上并且朝向间隔件侧向边缘斜面241滚动棒远端部分108,同时施加能量,直至观察到组织效果。当电极侧向边缘表面205足够靠近目标组织300时或者与其接触时将产生这个组织效果。如所示,高频电压足以将目标组织300和有源电极202之间的导电流体310转化成蒸气层312或等离子体。
在该过程期间,气体320和碎屑将被抽吸通过孔206、252或254至真空源(未示出)。此外,过量的导电流体和其他流体(例如,血液)将从目标位置300处被抽吸以有助于外科医生的视野。气泡320可以从蒸气或等离子体层312自然地上升,向上或者在中间方向上朝向孔206、252或254,并且被移除以便改进外科医生的目标组织的可视化。
图6示出根据至少一些实施例的方法。特别地,该方法开始(方框600)并且继续以:靠近目标组织放置棒的远端部分,该远端部分包括基本上平坦的有源筛网电极以及绝缘的间隔件,该筛网电极由间隔件支承(方框602);在有源电极和与该有源电极隔开的返回电极之间施加高频电压,该高频电压足以靠近有源电极的组织接触表面产生蒸气层或等离子体(方框604);定向远端部分使得有源电极的侧向边缘表面靠近目标组织并且治疗该目标组织(方框606);以及通过至少一个抽吸孔来抽吸组织碎片和气泡以便不破坏靠近有源电极侧向边缘表面的蒸气层或等离子体,该至少一个抽吸孔布置在与电极侧向边缘表面隔开的分离区域中,其中,该至少一个抽吸孔由部分有源筛网电极以及部分间隔件抽吸空腔限定(方框608)。该方法还可以包括至少三个抽吸孔,以及其中,抽吸的步骤进一步包括近似相等地通过该至少三个抽吸孔抽吸组织碎片和气泡,其中,该至少三个孔在与侧向边缘表面隔开的平面上是共面的,并且该至少三个孔是近似均等地隔开并且是不同大小的以便沿着侧向边缘表面的长度均匀地抽吸。该方法还可以包括靠近能够在有源电极上产生高电流密度点的几何结构特征产生蒸气层或等离子体,其中,该几何结构特征可以包括内部尖端。此后,该方法结束(方框610)。
图7示出根据至少一些实施例的方法。特别地,该方法开始(方框700)并且继续以:靠近布置在电外科棒的远端处的有源电极的第一边缘表面形生蒸气层以便治疗目标组织,其中,该第一边缘表面没有任何高电流密度的点(方框702);通过第一孔来抽吸流体和组织碎片,该第一孔仅由有源电极限定并且与靠近第一边缘表面的蒸气层隔开(方框704),通过延伸超出有源电极边缘表面的第二孔抽吸流体和组织碎片,该第二孔周界由有源电极的第二边缘表面部分地限定并且由部分绝缘的间隔件空腔部分地限定,该第二边缘表面具有至少一个内部或外部的尖锐几何结构或表面凹凸部,以及其中,第二孔还与靠近有源电极的第一边缘表面的蒸气层隔开并且还与第一孔隔开(方框706)。该方法可以进一步包括通过第三孔抽吸流体和组织碎片,该第三孔由有源电极的第三边缘表面部分地限定并且由部分绝缘的间隔件空腔部分地限定,以及其中,第一、第二和第三孔均是流体联接的。此后,该方法结束(方框708)。
虽然已经示出和描述了本公开内容的优选实施例,但是在不脱离本文中的范围或教导的情况下本领域技术人员能够对其做出修改。本文中所描述的实施例仅是示例性的并且不是限定性的。因为可以在本发明概念的范围内作出许多变化的实施例和不同的实施例,包括之后的等效结构、材料或方法,并且因为根据法律的描述性要求可以对在本文中详述的实施例做出许多修改,所以要理解的是,在本文中的细节被理解为说明性的而非限定性的意义。
Claims (17)
1.一种用于在患者的身体内或身体上的目标位置处治疗组织的电外科棒,包括:
细长轴,所述细长轴的特征在于手柄和远端部分,所述远端部分包括有源电极、绝缘的间隔件主体以及返回电极,其中,所述有源电极被支承在所述绝缘的间隔件主体上并且与所述返回电极隔开;
其中,所述有源电极限定侧向边缘表面和中间边缘表面;
其中,所述绝缘的间隔件主体限定与抽吸管腔流体连接的抽吸空腔,所述绝缘的间隔件主体进一步由至少一个锥形孔限定,所述至少一个锥形孔延伸超出所述中间边缘表面的至少一个并且指向所述抽吸空腔。
2.根据权利要求1所述的电外科棒,其中,至少一个有源电极侧向边缘表面没有任何凹凸部,并且与所述至少一个锥形孔隔开。
3.根据权利要求2所述的电外科棒,其中,所述有源电极进一步包括电极孔,所述电极孔与所述抽吸空腔流体连通并且与所述侧向边缘表面和所述至少一个锥形孔都隔开。
4.根据权利要求1所述的电外科棒,进一步包括至少两个锥形孔,所述至少两个锥形孔延伸超出所述中间边缘表面并且指向所述抽吸空腔,以及其中,所述两个锥形孔布置在相对的中间边缘表面上。
5.根据权利要求1所述的电外科棒,其中,所述有源电极的所述中间边缘表面包括至少一个内部尖端。
6.根据权利要求1所述的电外科棒,其中,所述有源电极限定与所述抽吸空腔对齐的中心抽吸孔。
7.根据权利要求1所述的电外科棒,进一步包括至少一个导电材料的固定导线,所述至少一个导电材料的固定导线电联接至并且机械固定至所述有源电极的组织接触表面,以及其中,所述至少一个固定导线沿着由至少一个有源电极导线孔、至少一个间隔件主体导线导管以及所述细长轴所限定的路径布置,以及其中,所述至少一个固定导线与高频能量源电连通。
8.根据权利要求1所述的电外科棒,其中,所述抽吸空腔的特征在于细长的漏斗形状,所述细长的漏斗形状在所述间隔件主体内渐细至圆形横截面的管腔。
9.根据权利要求8所述的电外科棒,其中,所述抽吸空腔渐细以便在所述抽吸空腔内限定最大间隙,所述间隙可操作以在所述抽吸空腔内捕获任意较大的组织碎片,使得在允许所述碎片进入圆形横截面的管腔之前,通过部分所述有源电极进一步消融所述组织碎片。
10.根据权利要求4所述的电外科棒,其中,所述锥形孔之一延伸超过第一中间边缘表面第一距离,并且第二锥形孔延伸超过所述有源电极的第二中间边缘表面第二距离,以及其中,所述第一距离小于所述第二距离。
11.根据权利要求4所述的电外科棒,其中,所述有源电极的第一中间边缘表面包括具有第一深度的至少一个第一内部尖端,以及所述有源电极的第二中间边缘表面包括具有第二深度的至少一个第二内部尖端,以及其中,所述第一内部尖端深度显著地小于所述第二内部尖端深度。
12.根据权利要求5所述的电外科棒,其中,所述至少一个内部尖端由两个相邻的弯曲部分之间的交点限定,所述交点的特征在于在所述两个相邻的弯曲部分之间的最小过渡。
13.一种用于在外科手术位置处治疗组织的电外科棒,包括:
细长的壳体,所述细长的壳体限定手柄端和在远端处的组织接触表面;
有源筛网电极,所述有源筛网电极限定部分所述组织接触表面,所述有源筛网电极布置在绝缘间隔件上,所述绝缘间隔件也限定部分所述组织接触表面;
其中,所述有源筛网电极包括没有任何表面凹凸部的至少一个侧向边缘表面,以及其特征在于至少一个表面凹凸部的远端边缘表面和其特征在于至少一个表面凹凸部的近端边缘表面;
其中,所述组织接触表面进一步包括在与所述侧向边缘表面隔开的分离位置处的第一抽吸孔,所述第一抽吸孔与布置在所述棒内的抽吸管腔流体连通,并且可操作以从所述外科手术位置去除碎屑,以及其中,所述第一抽吸孔具有由部分绝缘间隔件空腔限定并且由部分所述电极远端边缘表面或部分所述电极近端边缘表面限定的周界。
14.根据权利要求13所述的电外科棒,其中,所述组织接触表面进一步包括与所述侧向边缘表面和所述第一抽吸孔隔开的第二抽吸孔,所述第二抽吸孔与布置在所述棒内的抽吸管腔流体连通,并且可操作以从所述外科手术位置去除碎屑,以及其中,所述第二抽吸孔具有由部分所述绝缘间隔件空腔限定并且由部分所述电极远端边缘表面或部分所述电极近端边缘表面限定的周界。
15.根据权利要求14所述的电外科棒,进一步包括由所述有源筛网电极完全限定的第三抽吸孔,以及其中,所述第一、第二和第三抽吸孔在与所述侧向边缘表面中间地隔开的平面上是共面的。
16.根据权利要求15所述的电外科棒,其中,所述有源筛网电极具有两个相对的侧向边缘表面并且所述抽吸孔布置在一平面上,其特征为所述抽吸孔在所述两个相对的侧向边缘表面之间是等距离的。
17.根据权利要求13所述的电外科棒,其中,所述远端边缘表面凹凸部和近端边缘表面凹凸部是内部尖端。
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US9526556B2 (en) | 2016-12-27 |
US20150245862A1 (en) | 2015-09-03 |
AU2014384594A1 (en) | 2016-09-15 |
CN106456243A (zh) | 2017-02-22 |
US20170095285A1 (en) | 2017-04-06 |
US20240138900A1 (en) | 2024-05-02 |
US10548657B2 (en) | 2020-02-04 |
US20200146745A1 (en) | 2020-05-14 |
EP3110357A1 (en) | 2017-01-04 |
WO2015130405A1 (en) | 2015-09-03 |
JP2017506561A (ja) | 2017-03-09 |
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