CN105286990A - 精细解剖电外科装置 - Google Patents

精细解剖电外科装置 Download PDF

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CN105286990A
CN105286990A CN201510671185.3A CN201510671185A CN105286990A CN 105286990 A CN105286990 A CN 105286990A CN 201510671185 A CN201510671185 A CN 201510671185A CN 105286990 A CN105286990 A CN 105286990A
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electrosurgery
electrode
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active electrode
inch
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CN105286990B (zh
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D.伊万斯
M.D.福斯特
P.M.特兹拉夫
R.阿留鲁
J.沃洛兹科
J.E.古德
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Aathorocal Co Ltd
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    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/042—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating using additional gas becoming plasma
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1402—Probes for open surgery
    • 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
    • A61B2018/00583—Coblation, i.e. ablation using a cold plasma
    • 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
    • A61B2018/00589—Coagulation
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2218/00—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2218/001—Details of surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body having means for irrigation and/or aspiration of substances to and/or from the surgical site
    • A61B2218/002—Irrigation

Abstract

本发明涉及精细解剖电外科装置。至少一些示例性实施方案是这样的电外科棒，所述电外科棒包括：细长轴，其界定把手端和远端；第一排放孔，其位于所述细长轴的远端上；由导电材料形成的第一有源电极，其布置在所述细长轴的远端上，所述第一有源电极具有边缘特征部；由导电材料形成的第一返回电极，其布置为基本上与所述第一有源电极相距恒定距离；以及抽吸孔，其位于所述细长轴的远端上并且流体耦合到第二流体导管。

Description

精细解剖电外科装置
技术领域
本公开涉及精细解剖电外科装置。
背景技术
电外科领域包含多种宽松相关的外科技术，所述外科技术的共同点是都应用电能来修改病人组织的结构或完整性。电外科手术(procedure)通常通过施加极高频率的电流进行操作以切割或消融组织结构，其中所述操作可以是单极的或双极的。单极技术依靠远离病人身体上的外科手术部位而放置的用于返回电流的单独电极，并且其中外科装置只界定单个电极柱，所述电极柱提供外科效果。双极装置包括在相同支撑体上的两个或更多个电极，所述两个或更多个电极用于在其表面之间施加电流。
由于电外科手术和技术一般减少与切割操作相关的病人出血和损伤，所以电外科手术和技术特别有利。另外，电外科消融手术(其中组织表面和容积可重新成形)无法通过其他治疗方式复制。
射频(RF)能量由于其提供高效的组织切除和凝结并且相对容易通过入口或套管到达目标组织，所以在广泛范围的外科手术中使用。传统的单极高频电外科装置通常通过在有源电极与目标组织之间产生电压差，引起跨越电极与组织之间的物理间隙形成电弧而进行操作。在电弧与组织接触之时，由于电极与组织之间的高电流密度而发生快速组织加热。该高电流密度导致细胞液快速蒸发成蒸汽(stream)，从而沿着局部组织加热的路径产生“切割效果”。因此，组织沿着蒸发的细胞液的路径分开，在围绕目标组织部位的区域中引起不想要的附带组织损坏。这种附带组织损坏常引起不加选择的组织破坏，从而导致组织失去正常功能。另外，所述装置无法直接移除任何组织，而是取决于毁坏组织区和允许身体最终移除毁坏的组织。
目前用于组织消融的电外科技术可能不具备提供软组织精细解剖的能力。电外科装置的远端是宽且平的，产生容积组织移除的相对较宽的面积并且由于缺乏当前尖端几何形状所提供的精确度而使沿着组织平面进行精细解剖更加难以实现。此外，由于大的消融面积和装置尖端的整体尺寸使医师的外科手术视野变得模糊，识别平面变得更加困难。无法提供精细的软组织解剖是使用电外科技术用于组织消融中的一个重要劣势，尤其在关节镜手术、耳鼻喉手术和脊柱手术中。
传统的单极RF系统可以提供软组织的精细解剖能力，但是也可能引起高程度的附带热损坏。此外，这些装置可能无法控制受治疗组织的坏死深度。这些系统所产生的高热强度引起周围组织燃烧并烧焦，造成其余组织疼痛增加并且恢复较慢。此外，对电外科装置提供软组织的精细解剖的期望可能损及在允许其余组织的伴随止血和良好凝结的同时提供一致的消融切割而无显著附带损坏的能力。
因此，仍然期望改进的系统和方法用于经由电外科组织消融而进行软组织的精细解剖。特定而言，改进的系统可操作用于在精细解剖软组织手术中提供平滑和精确切割、切割期间的高效伴随止血与高效凝结能力的组合，其将提供竞争优势。
发明内容
根据本公开的一个方面，提供了一种电外科棒，包括：细长轴，其界定把手端和远端；连接器，其包括第一电针和第二电针；绝缘护套，其特征在于位于所述细长轴的远端上的多个排放孔，所述多个排放孔流体耦合到第一流体导管，以及所述第一流体导管在所述细长轴内；由导电材料形成的第一有源电极，其布置在所述细长轴的远端上，所述第一有源电极具有边缘特征部，并且所述第一有源电极电耦合到所述第一电针；由导电材料形成的第一返回电极，所述第一返回电极包括布置为与所述第一有源电极的远端顶点相距基本恒定的距离的延伸特征部，并且所述第一返回电极电耦合到所述第二电针；及抽吸孔，其位于所述细长轴的远端上并且流体耦合到第二流体导管，所述第二流体导管在所述细长轴内。
根据本公开的另一个方面，提供了一种系统，包括：电外科控制器，所述电外科控制器配置为相对于返回接线端在有源接线端处产生射频(RF)能量；电外科棒，其耦合到所述电外科控制器，所述电外科棒包括：细长轴，其界定把手端和远端；绝缘护套，其特征在于位于所述细长轴的远端上的多个排放孔，所述多个排放孔流体耦合到第一流体导管，以及所述第一流体导管在所述细长轴内；由导电材料形成的第一有源电极，其布置在所述细长轴的远端上，所述第一有源电极具有边缘特征部，并且所述第一有源电极电耦合到所述第一电针；由导电材料形成的第一返回电极，所述第一返回电极包括布置为与所述第一有源电极的远端顶点相距基本恒定的距离的延伸特征部，并且所述第一返回电极电耦合到所述第二电针；及抽吸孔，其位于所述细长轴的远端上并且流体耦合到第二流体导管，所述第二流体导管在所述细长轴内。
根据本公开的又一个方面，提供了一种方法，其包括：使导电流体在布置在电外科棒内的流体导管内流动，所述导电流体通过多个排放孔排放并且流经布置在所述流体导管远端的返回电极，并接着在有源电极上排放；在所述有源电极与所述返回电极之间施加电能；响应于所述能量，接近布置在所述有源电极上的边缘特征部形成局部等离子体；通过所述局部等离子体，消融接近所述边缘特征部的目标组织的一部分；及响应于所述能量，加热接近布置在所述有源电极上在远离所述边缘特征部隔开的位置处的平滑特征部的所述目标组织，以便由此提供伴随止血。
根据本公开的又一个方面，提供了一种电外科棒，包括：细长轴，其界定把手端和远端；连接器，其包括第一电针和第二电针；由导电材料形成的第一有源电极，其布置在所述细长轴的远端上，并且所述第一有源电极电耦合到所述第一电针；其中所述第一有源电极在第一分立位置处具有边缘特征部，并且在第二分立位置处具有平滑特征部；及由导电材料形成的第一返回电极，所述第一返回电极电耦合到所述第二电针。
附图说明
对于示例性实施例的详细描述，现在将参考附图，其中：
图1显示根据至少一些实施例的电外科系统；
图2A显示根据至少一些实施例的棒的一部分的透视图；
图2B显示根据至少一些实施例的棒的端视图；
图2C显示根据至少一些实施例的棒的横截面视图；
图3A显示根据至少一些实施例的棒的侧视图；
图3B显示根据至少一些实施例的棒的侧视图；
图3C显示根据至少一些实施例的棒的横截面视图；
图4A显示根据至少一些实施例的棒的横截面视图；
图4B显示根据至少一些实施例的棒的横截面视图；
图5显示根据至少一些实施例的棒连接器的端视图(左边)和横截面视图(右边)两者；
图6显示根据至少一些实施例的控制器连接器的端视图(左边)和横截面视图(右边)两者；
图7显示根据至少一些实施例的电外科控制器的电方块图；及
图8显示根据至少一些实施例的方法。
具体实施方式
贯穿下列说明书和权利要求书使用特定术语指代特定系统组件。如本领域技术人员将了解，设计并制造电外科系统的公司可用不同名称指代一个组件。这份文件不是旨在区分名称不同而功能相同的组件。
在下列论述和权利要求书中，术语“包含”和“包括”是以开放式方式使用，并且因此应被理解为意指“包含，但不限于......”。而且，术语“耦合”旨在意指间接或直接连接。因此，如果第一装置耦合到第二装置，那么所述连接可以通过直接连接或者通过经过其他装置和连接的间接电连接。
引用单数形式物件包含存在复数个相同物件的可能性。更具体而言，如在本文中和随附权利要求书中所使用，单数形式“一个”、“所述”包含复数个的引用，除非上下文另外明确指示。还应注意，可以将利力要求书撰写为排除任何可选元件。如此一来，这种陈述用作与权利要求元件的陈述有关的诸如“单独地”、“只”的排他性术语的使用或“否定”限制的使用的先行基础。最后，应了解除非另有定义，本文中所使用的所有技术和科学术语的意义和本发明属于的领域的普通技术人员所通常了解的意义相同。
“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引发组织变更效果的外科手术棒电极。
“返回电极”应意指用于相对于有源电极提供电子的电流流动路径的电外科棒电极，和/或本身不对作为治疗目标的组织产生电引发组织变更效果的电外科棒电极。
被称为“在细长轴内”的流体导管应不仅包含物理上存在于细长轴的内部容积内的单独流体导管，而且包含细长轴的内部容积本身是流体导管的情形。
在提供值范围的情况下，应了解介于所述范围的上限与下限之间的每个介入值以及所述范围中的任何其他所述值或介入值都包含在本发明内。而且，预期可以独立于或结合本文所描述的任何一个或多个特征而阐述和要求所描述的发明性变化的任何可选特征。
在本文中提到的所有现有主题(例如，公开、专利、专利申请和硬件)整体以引用的方式并入本文中，除非主题可能与本发明的主题相冲突(在冲突的情况下，应该以本文中所提出的为准)。引用的物件只提供用于在本申请的申请日之前的公开。本文中没有任何内容被解释为许可本发明无权因现有发明而将此类材料的日期提前。
在详细描述各个实施例之前，应了解本发明不限于本文所阐述的特定变化，因为在不脱离本发明的精神和范围下，可作出各种改变和修改，并且可用等效物替代。如本领域技术人员在阅读本公开内容后将了解，本文中所描述和图示的每个单独实施例具有在不脱离本发明的范围或精神下可以容易地与其他若干个实施例的任何特征分离或组合的分立组件和特征。另外，可以作出许多修改来适应特定情形、材料、物质的组合物、目标的处理、处理动作或步骤、本发明的精神或范围。所有这些修改旨在处于本文所做出的权利要求书的范围内。
图1图解说明根据至少一些实施例的电外科系统100。特定而言，电外科系统包括耦合到电外科控制器104(下文称为“控制器”)的电外科棒102(下文称为“棒”)。所述棒102包括界定远端108的细长轴106，远端108上布置至少一些电极。所述细长轴106还界定把手端或近端110，在外科手术期间，医师在所述把手端或近端110上握持棒102。棒102还包括容纳多根电导线(图1中没有具体显示)的易弯曲多导体电缆112，并且所述易弯曲多导体电缆112在棒连接器114中终止。如图1所示，例如通过外表面122(在图1的图示情况中，是正面)上的控制器连接器120将棒102耦合到控制器104。
在一些实施例中，棒102具有耦合到从外部可到达的管状构件的一个或多个内部流体导管(尽管图1的视图中不可见)。如所示，棒102具有易弯曲管状构件116和第二易弯曲管状构件118。在一些实施例中，易弯曲管状构件116用于提供导电流体(例如，盐水)给棒的远端108。同样地，在一些实施例中，易弯曲管状构件118用于对棒的远端108提供抽吸。
仍然参考图1，显示装置或界面面板124通过控制器104的外表面122可见，并且在一些实施例中，用户可以通过界面装置124和相关按钮126选择控制器104的操作模式。
在一些实施例中，电外科系统100也包括脚踏部件130。脚踏部件130可以包括一个或多个踏板装置132和134、易弯曲多导体电缆136和踏板连接器138。尽管只显示两个踏板装置132、134，但是可以实施一个或多个踏板装置。控制器104的外表面122可以包括耦合到踏板连接器138的对应连接器140。医师可以使用脚踏部件130来控制控制器104的各个方面，例如操作模式。举例而言，例如踏板装置132的踏板装置可以用于对棒102施加射频(RF)进行开关控制，并且更具体而言，用于控制消融模式中的能量。例如踏板装置134的第二踏板装置可以用于控制和/或设置电外科系统的操作模式。举例而言，踏板装置134的致动可以在消融模式的能量等级之间切换。
各个实施例的电外科系统100可以具有各种操作模式。一种这样的模式采用技术。特定而言，本公开内容的受让人是Coblation技术的所有者。Coblation技术涉及在棒102的一个或多个有源电极与一个或多个返回电极之间施加射频(RF)信号以在目标组织附近形成高电场强度。在所述一个或多个有源电极与目标组织之间的区域中，所述电场强度可足以蒸发在所述一个或多个有源电极的至少一部分上方的导电流体。导电流体可以是体内所固有存在的，例如血液，或者在一些情况中，其为细胞外液或细胞内液。在其他实施例中，导电流体可以是液体或气体，例如等渗盐水。在一些实施例中，例如锥间盘外科手术，导电流体例如通过内部通道和易弯曲管状构件116通过棒102在有源电极附近和/或向目标部位传送。
当导电流体加热到流体原子蒸发快于原子再凝结时，气体形成。当将充足的能量施加到所述气体时，原子相互碰撞，引起所述过程中电子的释放，并且形成电离气体或等离子体(所谓的“物质的第四种状态”)。换句话说，可以通过驱动电流流过气体或者将电磁波引导到气体中而加热气体和电离气体，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，并且所述过程层叠直到达到所希望的电离程度。可以在普利斯顿大学(1995)的等离子体物体实验室的R.J.Goldston和P.H.Rutherford的等离子体物理(其全部公开内容以引用的方式并入本文)中找到更完整的等离子体描述。
随着等离子体的密度变得足够低(即，对于水溶液，小于约1020个原子/立方厘米)，电子平均自由路径增加使得随后注入的电子引起等离子体内的撞击电离。当等离子体层中的离子微粒具有足够能量(例如，3.5电子伏(eV)或5eV)时，具有构成目标组织的分子的离子微粒的碰撞使目标组织的分子键断裂，使分子分离成自由基，然后自由基组合成气态或液态物种。通常等离子体中的电子携带电流或吸收电磁波，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大部分的等离子体热量，从而使离子微粒能够以实质上非热方式将目标组织分子断裂开。
通过分子分离(与热蒸发或碳化相反)，目标组织通过较大有机分子到较小分子和/或原子(例如氢、氧、碳氧化物、碳氢化合物和氮化合物)的分子分离而得以容积移除。分子分离完全移除组织结构，其与通过移除组织细胞内的液体和细胞外液而使组织材料脱水(如在相关技术的电外科干燥和蒸发中所发生)相反。分子分离的更详细描述可以在共同转让的美国专利第5,697,882号中找到，所述专利的全部公开内容以引用的方式并入本文中。
除了Coblation模式外，在特定情形下，图1的电外科系统100在用于称为凝结模式中时对密封较大动脉血管(例如，在直径约为1mm等级)也是有用的。因此，图1的系统可以具有消融模式，其中在第一电压下将RF能量施加到一个或多个有源电极，其足以影响组织的分子分离或分裂，并且图1的系统可以具有凝结模式，其中在第二较低电压下将RF能量施加到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。
由电外科系统100在棒102的远端108处产生的能量密度可通过调整多个因数而发生改变，所述多个因数例如：有源电极的数目；电极尺寸和间隔；电极表面积；电极表面上的凸起体和/或尖锐边缘；电极材料；施加的电压；一个或多个电极的电流限制(例如，通过将感应器放置为与电极串联)；与电极接触的流体的导电性；导电流体的密度；以及其他因数。因此，可以操纵这些因数来控制受激电子的能量等级。由于不同的组织结构可以具有不同的分子键，所以电外科系统100可配置为产生足以使特定组织的分子键断裂但不足以使其他组织的分子键断裂的能量。举例而言，脂肪组织(例如，脂肪)具有双键，双键需要高于4eV到5eV(即，约8eV等级)的能量等级来断裂。因此，在一些操作模式中，技术无法消融这类脂肪组织；然而，在较低能量等级下，技术可以用于有效消融细胞以用液体形式释放内部脂肪含量。其他模式可以具有增加的能量使得双键也可以用与单键类似的方式断裂(例如，升高电压或改变电极配置来增加电极上的电流密度)。
可以在共同转让的美国专利第6,355,032号、第6,149,120号、第6,296,136号中找到各种现象的更完整描述，所述专利的完整公开内容以引用的方式并入本文中。
图2A图解说明根据至少一些实施例的棒102的远端108的透视图。在一些实施例中，细长轴106的一部分可以由金属材料(例如，TP304等级不锈钢皮下注射管)制成。在其他实施例中，细长轴的部分可以由其他适合材料构造，例如无机绝缘材料。细长轴106可以界定把手端或近端110(图2中没有显示)处的圆形横截面，并且可以使远端108的至少一部分变平以界定椭圆或半圆形横截面。
在细长轴是金属的实施例中，远端108还可以包括耦合到细长轴106的非导电间隔件200。在一些情况中，间隔件200是陶瓷，但是也可等效使用当暴露于等离子体时抗老化的其他非导电材料(例如，玻璃)。间隔件200支撑由导电材料形成的电极，图2A中标记为202的图示有源电极。有源电极202界定由导电材料形成的暴露表面积，其中有源电极202是具有特定直径的线环。对于使用线环的实施例，线环可以是钼或钨，其直径介于0.025英寸和0.035英寸之间并且包含0.025英寸和0.035英寸，并且较优选是0.030英寸，并且与间隔件200相距约0.080英寸的暴露相隔距离。间隔件200可以具有阶跃特征部(stepfeature)201，阶跃特征部201用于通过提供非导电表面以搁置在相邻组织上而限制有源电极202的穿透深度，从而允许更受控制和精确的切割以及提供组织中热效果的更均匀深度。此外，间隔件200可以界定椭圆或半圆形横截面来提供有源电极202的平坦支撑轮廓。
在特定实施例中，有源电极在特定不同位置处具有有利于形成增强等离子体的边缘特征部203。特定而言，有源电极202可以由边缘特征部203(例如，齿状部分、切口、凹痕或凸起体)界定，边缘特征部203在每侧上具有介于0.008英寸与0.012英寸之间并且包含0.008英寸和0.012英寸的切口直径和深度，并且较优选是约0.010英寸，在有源电极202的中央部分中留下约0.010英寸厚度的薄段。参考图2B，边缘特征部203优选位于截开有源电极202的线直径的平面P1的相对侧上的至少两个位置中，并且在截开有源电极202宽度的第二平面P2的中央。图2C显示有源电极202和间隔件200的基本上沿图2B的平面P2截取的横截面图。特定而言，图2C显示特征部是有源电极202中的一对对称切口的实施例中的边缘特征部203的定向。在特定其他实施例中，预期但不显示，边缘特征部203也可以是沿着有源电极202通过模压、焊接或其他形成操作形成以提供外部边缘用于这些区域中的改进的局部等离子体而形成的凸出区段。在有源电极202的远端处的边缘特征部203有助于启动在有源电极202的相对中央中形成局部等离子体以进行平滑切割。简要参考图3A和图3B，有源电极202在远离边缘特征部203的第二不同位置处还具有圆形边缘或平滑特征部203b以导电/电阻加热在远离边缘特征部203隔开的位置处的组织。特定而言，有源电极202可以是线环，其特征在于：边缘特征部203在环的顶点上且平滑特征部203b相邻于边缘特征部203并且布置在形成有源电极202的环的任一侧。这种导电加热周围组织有助于在启动等离子体用于切割的同时提供小血管的伴随止血。
再次参考图2A，棒102包含用于完成有源电极202与控制器104之间的电流路径的返回电极204。返回电极204优选是界定轴106外部的半环状构件，并且返回电极204的远端部分优选是暴露的。返回电极204适当地连接到控制器104。返回电极204的至少一个近端部分布置在电绝缘护套206内，电绝缘护套206通常形成为一个或多个电绝缘护套或涂层，例如聚四氟乙烯、聚酰亚胺等等。提供环绕在返回电极204的一部分上方的电绝缘护套206防止返回电极204与任何相邻身体结构或外科医生之间的直接接触。这种身体结构(例如，腱)与暴露的共用电极构件204之间的直接电接触可能导致在引起坏死的接触点处的结构的不希望的加热和坏死。
返回电极204优选由导电材料形成，通常是选自由不锈钢合金、铂或其合金、钛或其合金、钼或其合金以及镍或其合金组成的组的金属。现在参考图3A，有源电极202与返回电极204之间的距离D优选是大致保持为恒定。如此一来，优选的是返回电极204的远端凸出部具有近似于有源电极202的几何形状的非均匀形状。在一个优选实施例中，返回电极204具有呈远端延伸的突出部205形式的延伸的特征部。这个延伸突出部205在有源环电极202与返回电极204之间维持接近均匀的距离。优选地，延伸突出部205接近返回电极204与有源电极202之间的距离(如在有源环电极202的顶点处所测量)，因而保持有源电极和返回电极的所有部分之间的距离D大致恒定。其也使返回电极204的远端更接近于作为目标的组织以改进流过有源电极与返回电极之间的组织和盐水的电流传导。这使得在凝结模式期间能够更均匀连续地传送电流穿过目标组织，提供较大深度的热穿透而改进血管凝结。
在一些实施例中，盐水传送到棒的远端108，可能有助于等离子体产生。再参考图2A和图2B，排放孔208被图解说明为位于与返回电极204相临近地隔开的远端108上。排放孔208形成在环绕返回电极204的一部分的绝缘护套206的最远处。绝缘护套206还在绝缘护套和返回电极204之间产生环状间隙，其中多个轴向布置的翼肋全部等距间隔以形成多个流体流动通道209，流体流动通道209将排放的导电流体引导朝向返回电极204和有源电极202。排放孔208的特征在于相关的多个流动通道209的最远端开口。在所示的特定实施例中，显示八个排放孔，但是可预期更少或更多个排放孔。排放孔208通过棒102内的流体导管流体耦合到易弯曲管状构件116(图1)。因此，盐水或其他流体可以抽吸到易弯曲管状构件116(图1)中并且通过多个流体流动通道209和排放孔208排放以进一步帮助围绕返回电极204的圆周形成一致湿润。
在其他实施例中，在棒102的远端108处提供抽吸。图3B图解说明在装置的远端108处的抽吸孔207(即，抽吸端口207)，并且其被布置为穿过非导电间隔件200并部分界定返回电极204中的开口。抽吸端口207布置在远端108处，并且在特定实施例中优选只位于间隔件200的一侧并且布置在间隔件200的下表面上(使得当在使用时，抽吸端口207优选关于接近目标组织的角度布置在下方)，并且因此可以布置在间隔件200的与突出部205相对侧。抽吸端口207抽吸远端108附近的面积，以移除过量流体和消融剩余物。抽吸端口207的位置还提供尖端的相对侧上的有源电极和返回电极的充分湿润，盐水在轴的非抽吸面上围绕有源电极尖端从排放孔208向下流，然后向上回拉到棒的具有抽吸端口207的下侧。申请人已经发现特别有利的是，将导电流体流引导到远离抽吸端口207的分立区域以提供返回电极204的暴露表面的更广湿润，使得能够形成更均匀的等离子体。
另外，简要参考图2B和图3B两者，抽吸端口207可以从平面P1向下偏移，而且平面P1将细长轴106的远端108的厚度T截开。图3C显示基本上沿着图2B的平面P1截取的横截面图。特定而言，图3C显示抽吸端口207以及由壁212界定的间隔件流体导管210。流体导管210还包括抽吸室216，抽吸室216具有流体导管开口214。在操作中，对易弯曲管状构件118(图1)提供抽吸，且易弯曲管状构件118延伸到棒102的内部容积中变成抽吸室216的开口214或流体耦合到抽吸室216的开口214。因此，导电流体、分子分离组织以及组织件通过抽吸端口207汲取到流体导管210中，并且最终通过抽吸室216和开口214。抽吸室216与抽吸端口207相临近地隔开，并且本说明书的发明人已经发现抽吸室216的特定深度和开口214的宽度比其他的运作得好。举例而言，在不增加抽吸室216的面积的情况下，流体导管210可能会遭遇堵塞。同样地，如果易弯曲管状构件118在开口114处的耦合点的直径没有增加，那么堵塞可能发生。根据至少一些实施例，流体导管210的自然状态在抽吸端口207和开口214之间的长度上转变。流体导管210的入口由抽吸孔宽度Wa标记。根据至少一些实施例，界定流体导管210的内壁212在长度L平滑地转变到由开口214处的开口宽度Wo标记的宽度的变化，其中宽度变化到开口214处的Wo应是轴的全部ID的至少一半。另外，现在再参考图2C，流体导管210的深度在其转变到抽吸室216时应至少平滑地变化到由深度Dc标记的深度，其中深度Dc的顶点应为间隔件200的厚度T(图2B)的至少一半并且然后平滑地转变到开口214处的深度Do。本发明人只是以举例的方式提出上文所述的流体导管210的自然状态。可以等效地使用流体导管210和抽吸室216的部分的形状、各自宽度以及深度从抽吸端口207到开口214的其他变动和转变。
举例而言，如图2A-3B中所示，返回电极204不是直接连接到有源电极202。为完成电流路径使得在存在目标组织的情况下有源电极202电连接到返回电极204，使导电液体(例如，等渗盐水)沿着源自排放孔208并且接触返回电极204和有源电极202两者的液体路径流动。当在有源电极202和返回电极204之间施加电压差时，将在有源电极202的远端处产生高电场强度，电流从有源电极202流动到返回电极204，高电场强度引起与有源电极202的远端相邻的目标组织的消融。
图4A显示根据至少一些实施例的棒102的横截面正视图。特定而言，图4显示耦合到细长轴106的把手端或近端110。如所示，细长轴106在把手内伸缩，但是还可以等效使用将细长轴耦合到把手的其他机构。细长轴106界定用于若干个目的的内部导管400。举例而言，在图4所示的实施例中，电导线402和404延伸通过内部导管400以分别电耦合到有源电极202和返回电极204。同样地，易弯曲管状构件116延伸通过内部导管400以经由绝缘护套206流体耦合到多个流动通道209和排放孔208。
内部导管400也用作抽吸路线。特定而言，图4B图解说明抽吸端口207。在所示实施例中，易弯曲管状构件118(通过其执行抽吸)通过把手耦合并且接着流体耦合到内部导管400。因此，通过易弯曲管状构件118提供的抽吸在抽吸端口207处提供抽吸。当沿着内部流体导管400汲取流体时，被汲取到内部流体导管400中的流体可以与易弯曲管状构件116的存在于内部导管内的部分邻接；但是易弯曲管状构件116是密封的，并且因此抽吸的流体不会与通过易弯曲管状构件116抽吸的流体(例如，盐水)混合。同样地，当沿着内部流体导管400汲取流体时，被汲取到内部流体导管400中的流体可以与电导线402和404的在内部流体导管400中的部分邻接。但是，电导线与将导线与内部流体导管400内的任何物质电隔离并流体隔离的绝缘材料绝缘。因此，在所示实施例中，内部流体导管用于两个目的，一个是用作易弯曲管状构件116和电导线横越其而到达远端108的路径，而且用作通过其发生抽吸的导管。在其他实施例中，易弯曲管状构件118可以部分延伸通过或者全部延伸通过细长轴106，并且因此更直接地耦合到抽吸孔。
图4A和图4B也图解说明，根据至少一些实施例，细长轴106的一部分(例如，部分410)是圆形，并且细长轴106的另一部分(例如，部分412)是平的，以界定椭圆形或半圆形横截面。在一些实施例中，使远端3厘米或少于3厘米变平，并且在一些情况中，使最后2厘米变平。在其他实施例中，整个细长轴可以界定椭圆形或半圆形横截面。此外，在所示特定实施例中，部分410的轴和部分412的轴之间的角度不为0，并且在一些实施例中，部分410的轴和部分412的轴之间的锐角是20度，但也可以等效使用更大或更小的角。
如图1中所示，易弯曲多导体电缆112(且更特定而言其组成的电导线402、404以及其他可能的组成物)耦合到棒连接器114。棒连接器114耦合控制器104，并且更特定而言，耦合控制器连接器120。图5显示根据至少一些实施例的棒连接器114的横截面视图(右边)和端正视图(左边)。特定而言，棒连接器114包括突出部500，突出部500结合控制器连接器120上的槽孔(在图6中显示)运作以确保棒连接器114和控制器连接器120只以一个相对定向耦合。示意性的棒连接器114还包括从棒连接器114凸出的多个电针502。在许多情况中，所述电针502的每一个电针耦合到电导线504的一根电导线(所述电导线504中的两根电导线可以是图4的导线402和404)。换句话说，在特定实施例中，每个电针502耦合到单根电导线，并且因此每根示意性电针502耦合到棒102的单个电极。在其他情况中，单个电针502耦合到电外科棒102上的多个电极。虽然图5显示四个示意性电针，但是在一些实施例中，棒连接器114中可以存在少至2个电针和多至26个电针。
图6显示根据至少一些实施例的控制器连接器120的横截面视图(右边)和端视图(左边)。特定而言，控制器连接器120包括槽孔600，槽孔600结合棒连接器114上的突出部500(在图5中显示)运作以确保棒连接器114和控制器连接器120只在一个定向上耦合。示意性控制器连接器120还包括存在于控制器连接器120的各自孔内的多个电针602。电针602耦合到控制器104内的电压产生器的接线端(下文中进行更全面论述)。当棒连接器114和控制器连接器120耦合时，每个电针602耦合到单个电针502。尽管图6只显示四个示意性电针，但是在一些实施例中，在棒连接器120中可以存在少至两个电针，以及多至26个电针。
尽管示意性棒连接器114显示为具有突出部500和阳电针502，并且控制器连接器120显示为具有槽孔600和阴电针602，但是在替代实施例中，棒连接器具有阴电针和槽孔，并且控制器连接器120具有突出部和阳电针，或者其他组合。在其他实施例中，连接器内电针的配置可以实现仅单个定向用于连接连接器，并且因此突出部和槽孔布置可以省略。在其他实施例中，可以等效使用用于确保棒连接器和控制器连接器只以一个定向耦合的其他机械布置。在只具有两个电极的棒的情况下，并且所述电极如物理情形指示的可以是有源电极或返回电极，可能无需确保连接器以特定定向耦合。
图7图解说明根据至少一些实施例的控制器104。特定而言，控制器104包括处理器700。处理器700可以是微控制器，并且因此微控制器可以与随机存取存储器(RAM)702、只读存储器(RAM)704、数字模拟转换器(D/A)706、数字输出端(D/O)708和数字输入端(D/I)710整合成一体，处理器700还可以提供一根或多根外部可用的外围总线(例如串行总线(例如，I2C)、并行总线或其他总线)和对应的通信模式。处理器700还可以与通信逻辑712整合成一体以使处理器700能够与外部装置以及内部装置(例如显示装置124)通信。尽管在一些实施例中，控制器104可以实现微控制器，但是在其他实施例中，处理器700也可以实现为与单独RAM；ROM；通信D/A、D/O和D/I装置以及用于与外围组件通信的通信端口硬件结合的独立中央处理器。
ROM704存储可由处理器700执行的指令。特定而言，ROM704可以包括软件程序，所述软件程序实现周期性地减小电压产生器输出以改变等离子体相对于棒电极的位置(下文进行更多论述)以及通过显示装置124和/或脚踏组件130(图1)与用户建立连接的各个实施例。RAM702可以是处理器700的运作存储器，其中可以暂时存储数据并且可以根据数据执行指令。处理器700通过D/A转换器706(例如，电压产生器716)、数字输出端708(例如，电压产生器716)、数字输入端710(即，推钮开关126和脚踏板组件130(图1))和其他外围装置而耦合到控制器104内的其他装置。
电压产生器716产生可选择的交流(AC)电压，交流(AC)电压施加到棒102的电极。在各个实施例中，电压产生器界定两个接线端724和726。根据各个实施例，电压产生器产生跨接线端724和726的交流(AC)电压。在至少一些实施例中，电压产生器716从控制器104中的电源平衡电“浮动”，并且因此当关于控制器104内的地面接地或共同端(例如，共同端728)测量时，接线端724、726上的电压可能显示或可能不显示电压差，即使当电压产生器716是有源时也是这样。
通过电压产生器716在有源接线端724和返回接线端726之间产生和施加的电压是RF信号，在一些实施例中，所述RF信号具有在约5千赫兹(kHz)和20兆赫兹(MHz)之间的频率，在一些情况中，在约30kHz和2.5kHz之间，通常在约100kHz和200kHz之间。在与耳鼻咽喉学-头颈手术相关的应用中，约100kHz的频率表现为最有效。由电压产生器716产生的RMS(均方根)电压可以在从约5伏(V)到1000V的范围内，优选在从约10V到500V的范围内，通常在约100V到350V之间，这取决于有源电极尺寸和操作频率。由电压产生器716产生的用于消融或切割的峰至峰电压在一些实施例中为在10V到2000V范围中的方波形状，且在一些情况中在100V到1800V的范围中，且在其他情况中，在约28V到1200V的范围中，通常在约100V到320V峰至峰范围中(再次取决于电极尺寸和操作频率)。
仍然参考电压产生器716，电压产生器716取决于对被治疗的目标组织施加的电压和/或棒102所选定的最大允许温度向每个电极传送在数毫瓦到成百上千瓦范围内的平均功率电平。电压产生器716配置为使用户能够根据特定手术的具体需求选择电压电平。可以在共同转让的美国专利第6,142,992号和第6,235,020号中找到对一种适合的电压产生器716的描述，所述两个专利的全部公开内容以引用的方式并入本文中用于所有目的。
在一些实施例中，电压产生器716的各个操作模式可以通过数字模拟转换器706控制。也就是说，举例而言，处理器700可以通过将可变电压提供给电压产生器716而控制输出电压，其中所提供的电压与电压产生器716所产生的电压成比例。在其他实施例中，处理器700可以通过来自数字输出端708装置的一个或多个数字输出信号或通过使用通信装置712的基于封包的通信而与电压产生器通信(没有具体显示连接以便不会使图8变得过度复杂)。
图7也显示棒102的远端108的简化侧视图。如所示，棒102的示意性有源电极202通过连接器120电耦合到电压产生器716的接线端724，并且返回电极204电耦合到电压产生器716的接线端726。
图8显示根据至少一些实施例的方法。特定而言，所述方法开始(方块800)并前进到：使导电流体在布置在电外科棒内的流体导管内流动，导电流体通过多个排放孔排放并且流经布置在流体导管远端的返回电极，并且接着在有源电极上排放(方块802)；在有源电极与返回电极之间施加电能(方块804)；响应于能量，在接近布置在有源电极上的边缘特征部的形成局部等离子体(方块806)；通过局部等离子体消融接近边缘特征部的目标组织的一部分(方块808)；以及响应于能量，加热远离边缘特征部隔开的位置处的目标组织以便因此提供伴随止血(方块810)。并且随后方法结束(方块812)。
上面的论述意欲示意本发明的原理和各个实施例。大量变动和修改是可行的。举例而言，尽管在一些情况中，电极设计为上电极和下电极，这种设计出于论述目的，并且不应被视为在外科手术期间需要与重力的任何关系。希望下文权利要求书被理解为包含所有这些变动和修改。
尽管已经显示和描述本公开内容的优选实施例，但是在不脱离本文中的范围和教示下，本领域技术人员可以对其作出修改。本文所描述的实施例只为示例性并且无限制之意。由于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，包含等效结构、材料或其方法，并且由于根据法律的描述性要求可以在此处详细的实施例中作出许多修改，所以应理解本文中的细节被理解为示意性而不是限制之意。

Claims (16)

1.一种电外科棒，其包括：
细长轴，其界定把手端和远端；
连接器，其包括第一电针和第二电针；
绝缘护套，其特征在于多个排放孔位于所述细长轴的远端上，所述多个排放孔流体耦合到第一流体导管；以及所述第一流体导管在所述细长轴内；
由导电材料形成的第一有源电极，其布置在所述细长轴的远端上，所述第一有源电极具有边缘特征部，并且所述第一有源电极电耦合到所述第一电针；
由导电材料形成的第一返回电极，所述第一返回电极包括布置为基本上与所述第一有源电极的远端顶点相距恒定距离的延伸特征部，并且所述第一返回电极电耦合到所述第二电针；及
抽吸孔，其位于所述细长轴的远端上并且流体耦合到第二流体导管，所述第二流体导管在所述细长轴内，其中所述抽吸孔偏移将所述细长轴的远端厚度截开的平面。
2.根据权利要求1的电外科棒，其中所述边缘特征部是选自由圆齿状部分、切口、凹痕和凸起体组成的组中的至少一个。
3.根据权利要求1的电外科棒，其中所述边缘特征部包括切口，所述切口在每侧上具有介于0.008英寸与0.012英寸之间并且包括0.008英寸和0.012英寸在内的直径和深度。
4.根据权利要求1的电外科棒，其中所述边缘特征部包括切口，所述切口在每侧上具有0.010英寸的直径和深度。
5.根据权利要求1的电外科棒，其中所述边缘特征部包括布置在所述第一有源电极的相对侧上的第一切口和第二切口。
6.根据权利要求1的电外科棒，其中第一有源电极还包括线环。
7.根据权利要求6的电外科棒，其中所述线环具有介于0.025英寸与0.035英寸之间并且包括0.025英寸和0.035英寸在内的直径。
8.根据权利要求6的电外科棒，其中所述线环具有0.030英寸的直径。
9.根据权利要求1的电外科棒，其中所述第一有源电极与非导电间隔件相距0.080英寸的暴露相隔距离。
10.根据权利要求9的电外科棒，其中所述非导电间隔件包括可操作用于限制所述第一有源电极的组织穿透深度的阶跃特征部。
11.根据权利要求1的电外科棒，其中所述延伸特征部包括突出部。
12.根据权利要求1的电外科棒，其中所述多个排放孔流体耦合到多个流体流动通道，所述多个流体流动通道布置在介于所述绝缘护套与所述细长轴之间的环形间隙中。
13.根据权利要求1的电外科棒，其中所述多个排放孔环绕所述细长轴。
14.根据权利要求1的电外科棒，其中所述多个排放孔与所述第一返回电极的最远的尖端相接近地隔开。
15.根据权利要求1的电外科棒，其中所述抽吸孔界定孔宽度，并且其中间隔件流体导管的宽度从所述孔宽度转变到不小于所述轴的内径的一半的流体导管开口宽度。
16.根据权利要求15的电外科棒，其中所述间隔件流体导管的深度进一步从不小于非导电间隔件厚度的一半的抽吸室深度转变到流体导管开口深度。
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