CN108472073A - 具有多个单极电极组件的电外科设备 - Google Patents

具有多个单极电极组件的电外科设备 Download PDF

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CN108472073A
CN108472073A CN201680074561.3A CN201680074561A CN108472073A CN 108472073 A CN108472073 A CN 108472073A CN 201680074561 A CN201680074561 A CN 201680074561A CN 108472073 A CN108472073 A CN 108472073A
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monopole
electrode
electrosurgery unit
blade
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B·D·帕特尔
J·西尔维斯特
D·休伯尔班克
S·R·保加尔
W·赛欧佩斯
R·帕特尔
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Abstract

公开了一种具有手持件的电外科设备，手持件包括控制器和从手持件延伸的电极组件。电极组件包括单极刀片和单极电极。单极刀片包括部分地涂覆有绝缘体并且被电耦合到控制器的导电元件以选择性地递送单极射频(RF)切割信号。单极电极与单极刀片间隔开并且电隔离。单极电极包括被电耦合到控制器的暴露的主导电表面以伴随被分散的流体选择性地递送单极RF止血密封信号。

Description

具有多个单极电极组件的电外科设备
背景技术
本公开通常涉及用于在外科手术过程中使用的医疗设备、系统和方法的领域。更具体地，本公开涉及利用电外科设备提供用于对包括骨头的身体组织的进行切割、凝固、止血或密封的电外科设备、系统和方法。
电外科包括如在利用合适的电源进行激励的电极的帮助下对组织进行切割、凝固、止血和/或密封的这样的技术。典型的电外科设备施加单极布置中有效(active)电极和患者的接地身体上的返回电极之间或者双极布置中设备上的有效电极和返回电极之间的电势差或信号，以将电能递送到区域，在该区域处组织将受到影响。电外科设备通常由外科医生手持并且经由布线被连接到电源(诸如，具有发电机的电外科单元)。
电外科设备将电能传递通过电极之间的组织以提供凝固以控制出血以及止血以密封组织。电外科设备还可以通过使用在电极上形成的等离子体来切割组织。与等离子体接触的组织经历细胞液的快速蒸发以产生切割效应。通常，切割和凝固常常由单极布置中的电极执行，而止血由双极布置中的电极执行。
电信号可以作为通常在射频(RF)范围中的高频脉冲串或连续信号被施加到电极以执行不同的技术。信号可以包括可变的一组参数，诸如，功率或电压水平、波形参数，诸如，频率、脉冲持续时间、占空比和对于给定的技术可以是特别恰当或优选的其他的信号参数。例如，外科医生可以使用具有一组参数的第一RF信号以形成等离子体来切割组织并且使用具有对于凝固更优选的另一组参数的第二RF信号来控制出血。外科医生还可以使用将采用具有另一组参数的附加RF信号的双极布置中的电极或双极电外科设备，以用于对组织进行止血密封。
在历史上，两种不同的电外科设备，一种单极而另一种双极，被用于在外科手术中执行不同的功能，诸如，组织切割和凝固以及组织密封。例如，外科医生可使用单极电外科设备来切割和凝固组织并使用双极电外科设备来密封组织。当在外科手术期间执行不同的技术或功能时，外科医生可以在不同的设备之间切换。在设备之间切换可以导致不期望的效应，诸如，较长的手术时间、在外科手术期间不期望发生的对组织的较长的响应时间、较高的费用以及增大的不准确或不精确的可能性。
为了解决这些问题，一些能够执行多种技术(诸如，切割和凝固组织或者包括对组织的流体辅助密封的切割、凝固和密封组织)的电外科设备已经被开发。若干这种电外科设备例如在Greeley等人的美国专利No.8,632,533、Conley等人的美国专利申请公开No.2012/000465、Bloom等人的美国专利申请公开No.2011/0178515中被描述。
已经被开发出来的若干设备包括具有两个电极的手持件。这些设备可以被配置为双极电极，该双极电极被连接到双极电源以双极模式来操作，以例如密封组织。为了在单极模式中操作同一两电极设备，以例如切割组织，两个电极中的一个可选择性地被停用并且两个电极中的另一个被耦合到单极电源。以这种方式，多种功能的设备可取决于所期望的组织治疗而利用一个或两个电极来将治疗提供给组织。
尽管具有利用单个设备执行不同功能的能力，但是当单极功能被期望时，在单极操作期间设备的两个电极中的仅一个被使用并且停用的第二电极可阻碍外科医生的视线。此外，停用的电极可不必要地阻止单极电极进入更小的空间或组织区域，否则该更小的空间或组织可被访问，如果未使用的电极没有被暴露的话。又进一步地，设备可不与独立的双极和单极设备类似地进行执行。
发明内容
提供本发明内容以便以简化形式介绍将在以下具体实施方案中进一步描述的概念的选择。
在一个方面，本公开涉及具有手持件的电外科设备，该手持件包括控制器和从手持件延伸的电极组件。电极组件包括单极刀片和单极电极。单极刀片包括部分地涂覆有绝缘体并且被电耦合到控制器的导电元件以选择性地递送单极射频(RF)切割信号。单极电极与单极刀片间隔开并且电隔离。单极电极包括被电耦合到控制器的暴露的主导电表面以伴随被分散的流体选择性地递送单极RF止血密封信号。在一个示例中，控制器包括按钮以在将单极RF止血密封信号电耦合到单极电极之前将单极刀片电耦合到单极电极。
在一个方面，本公开涉及具有手持件和从手持件延伸的电极组件的电外科设备。电外科设备被配置成与电外科发电机单元和返回电极一起使用。电极组件包括被耦合到单极刀片和单极电极并且将单极刀片与单极电极进行电隔离的电绝缘中间组件。单极刀片和单极电极可以在单极布置中被配置为有效电极。电外科设备被配置成将用于切割的单极RF信号以及用于凝固的单极RF信号递送到单极刀片。电极组件还被配置成分散流体(诸如，盐水)，并且利用单极电极递送用于止血密封的单极RF信号。
在一个方面，本公开涉及具有包括控制器的手持件的电外科设备。轴从手持件延伸出来。轴包括被配置成递送流体的海波管(hypotube)并且包括导电元件。电极组件从轴延伸。电极组件包括单极刀片和单极电极。单极刀片包括部分地涂覆有绝缘体并且被电耦合到控制器的导电元件以选择性地递送单极射频(RF)切割信号。单极电极与单极刀片间隔开并且电隔离。单极电极包括经由导电元件被电耦合到控制器的暴露的主导电表面以经由海波管伴随被分散的流体选择性地递送单极RF止血密封信号。在一个示例中，轴具有可变的长度，并且海波管包括可延伸的且可屈服地折叠的(yieldably collapsible)线圈段。
在一个示例中，单极刀片利用用于经由等离子体进行切割的单极RF信号对组织进行干燥。用于切割组织的等离子体的生成包括在单极刀片中产生非常高的电流密度。在单极布置中，有效电极通常比返回电极小得多以允许等离子体在有效电极处而不是在返回电极处形成。为了在单极布置中进一步增大电流密度、减小被用于切割组织的功率，或者两者的组合，单极刀片可包括导电元件(诸如，不锈钢)，该导电元件部分地涂覆有电绝缘材料(诸如，玻璃或陶瓷)以留有导电元件的小的暴露区域以在单极刀片上生成等离子体。玻璃或陶瓷绝缘体还用作热屏蔽，其在覆盖有绝缘体的导电元件的位置中减少单极刀片的外表面上的热量，以保护组织区域免受热损伤。
导电元件和绝缘涂层协作以形成坚固的、充分尺寸设计(substantially sized)的切割刀片，该坚固的、充分尺寸设计的切割刀片具有类似尺寸设计的金属刀片的导电表面区域的仅一部分以增大电流密度并且减小热损伤区域的尺寸。因此，单极导电元件用作线束并且将单极能量进行聚焦从而允许其生成等离子体以用于以减小的功率、在导电元件处的更高的电流密度、或者减小的功率和比在类似尺寸设计的金属刀片中可用的电流密度更高的电流密度的组合进行精确解剖和凝固。
单极电极由未经涂覆的金属进行配置以具有比单极刀片显著较大的导电表面区域。单极电极被配置成避免生成等离子体，并且利用用于止血密封的单极RF信号来产生相对低的电流密度。此外，示例的单极电极被配置有流体端口以分散流体以用于止血密封。在一个示例中，导电海波管被电耦合到单极电极并且被流体耦合到流体端口以将用于止血密封的单极RF信号递送到单极电极并且分散被激励的导电流体。中间组件将单极电极和海波管与单极刀片进行电隔离。
电极组件可容易地大规模地制造。在一个示例中，海波管被焊接到单极电极，利用电绝缘塑料(例如，聚四氟乙烯(PTFE)基材料或其他)对海波管进行包覆模制(overmolde)以形成中间组件。单极刀片被附连到中间组件。电极组件可以被电耦合到控制器、被流体耦合到导管并且被焊接到手持件的轴以形成电外科设备。
单极刀片可以具体地被配置成用于切割或干燥组织并且利用切割和凝固RF能量进行操作，其利用相对高的阻抗电极和高的电流密度以形成等离子体来执行。单极电极可以具体地被配置成执行止血组织密封的技术，该止血组织密封的技术利用相对较低的阻抗电极和较低的电流密度和分散的流体来执行。因此，临床医生可以在不必改变设备或从单极改变到双极模式或反之亦然的情况下执行多个电外科功能。
附图说明
图1是示出根据本公开的系统的包括与流体源和示例手持电外科设备组合的示例电外科单元的实施例的正视图。
图2是示出包括多个单极电极组件的图1的电外科设备的示例的透视图。
图3是示出了展示示例的多个单极电极组件的图2的电外科设备的特写透视图。
图4是示出图3的多个单极电极组件的透视图。
图5是示出图3的多个单极电极组件的分解图。
图6是示出图3的多个单极电极组件的截面的俯视图。
图7是示出用于图2的电外科设备的海波管(hypotube)的示例的特写图。
图8是示出图7的海波管的示例的侧视图。
具体实施方案
贯穿说明书，相似的附图标记和字母指示贯穿若干视图的对应结构。而且，特定示例性实施例的任何特定特征(多个)可同等地随其适合地应用到本说明书的任何其他的示例性实施例(多个)。也就是说，在本文所描述的各种示例性实施例之间的特征是随其适合地可互换的并且可不是排他的。从本说明书，应该清楚的是，术语“远侧”和“近侧”是参考设备的用户而作出的。
图1示出包括与示例手持电外科设备30组合的电外科单元10的系统60的一个示例的正视图。在一个示例中，设备30可配置成用于在第一单极模式中使用第一单极电极进行包括电灼和凝固的切割和密封。在另一示例中，设备30可以被配置成提供用于在第二单极模式中与流体源20结合使用至少第二单极电极来提供对包括骨头的组织的止血密封，或用于其他的电外科过程。
系统60可以被携载在具有支持构件4的移动式推车2上，支持构件4包括中空的圆柱形柱杆，该推车包括平台6，平台6包括柱脚桌以提供用于对电外科单元10的进行定位的平的、稳定的表面。推车2可以包括杆8，该杆8具有可通过使得杆8上下滑动来调整的高度。流体源20可以被支撑在杆8的顶部处。
流体源20可包括一袋流体，流体12可从该一袋流体流出通过点滴腔14、到递送导管16并且到手持电外科设备30。在一个示例中，流体12包括盐水并且可以包括生理盐水，诸如，0.9％重量/体积的氯化钠(NaCl)溶液。盐水是导电流体，并且可以使用其他合适的导电流体。在其他的示例中，流体可包括非导电流体(诸如，去离子水)，该非导电流体仍可提供优于使用无流体的优点，并且可支持电外科设备30的部分以及组织的冷却或者减少组织粘到电外科设备30的发生。
在示例中，流体递送导管16穿过泵22以将流体输送到电外科设备30并且控制流体流动。在一个示例中，泵22是蠕动泵，诸如，旋转式蠕动泵或线性蠕动泵。蠕动泵可以通过被置于递送导管的外表面上的间歇力来输送流体通过递送导管16。常常在电外科设备30的使用期间应用蠕动泵，因为泵的机械元件将力置于递送导管的外表面上且不与流体直接接触，这可以减小流体污染的可能性。系统60的其他示例可不包括泵，并且流体可以经由重力被提供到电外科设备30。
示例性电外科单元10可以将至少一个或多个单极RF功率输出提供给指定的电外科仪器，诸如，电外科设备30。在一个示例中，电外科单元10可以被用于将RF能量递送到指示用于软组织的切割和凝固的仪器，并且用于将RF能量与流体同时递送到指示用于软组织和骨头的止血密封和凝固的仪器。在一个示例中，电外科单元10可以能够同时地或单独地对指定的单极电极供能。
在电外科设备30的单极操作期间，有效电极利用电外科设备30来提供，而无关(indifferent)或中性电极以位于患者身上的接地焊盘分散电极的形式被提供。例如，接地焊盘分散电极通常是在背上、臀部上、大腿上或在外科手术期间其他合适的解剖位置上。在这种配置中，接地焊盘分散电极常常被称为患者返回电极。RF能量的电路通过患者在有效电极和接地焊盘分散电极之间被形成。(相比之下，双极电外科设备包括第二电极，常常被称为提供第二电极(electrical pole)的返回电极。不使用接地焊盘分散电极。在双极设备的第一和第二极之间生成RF能量的电路。电流不再流动通过患者的身体到接地焊盘分散电极，而是流动通过双极设备的极之间的组织的局部部分。)
示例中的电外科设备30经由线缆24被连接到电外科单元10。线缆24包括与电外科单元10上的插座36连接的插头34。在一个示例中，插座可以对应于有效电极插座并且一个或多个插座可对应于对电外科设备30的控制。又进一步地，插座可以对应于第二有效电极插座。附加的线缆可将接地焊盘电极与电外科单元10的接地焊盘插座进行连接。在一些示例中，递送导管16和线缆24可被组合以形成单根线缆26。
所描述的电外科单元10的特征是用于说明的，并且适合用于与设备30一起使用的电外科单元可包括以下所描述特征的一些、所有或除以下所描述特征之外的其他特征。在一个示例中，电外科单元10能够以至少单极模式以及在单极模式内的多个功能(诸如，单极切割功能、单极凝固功能和单极止血或组织密封功能)进行操作。在单极切割功能中，单极RF能量以第一功率水平和/或第一波形(总称为第一、或切割RF能量设置)被提供到设备30。例如，可以以相对低的电压和连续的电流(100％开启，或100％的占空比)提供用于切割功能的切割RF能量。标称阻抗可以在300到1000欧姆范围之间以用于切割功能。在用于切割的90瓦特的功率设置处，电压可以从大约164到300伏特均方根(RMS)范围。在单极凝固功能中，单极RF是以不同于第一功率水平或第一波形中的至少一个的第二功率水平和/或第二波形(总称为第二、或凝固RF能量设置)被提供到电极的能量。例如，可以以比切割电压相对更高的电压并利用脉冲电流(诸如，分别为1％到6％开启和99％到94％关闭(或1％到6％的占空比))提供用于凝固功能的凝固RF能量。构想了其他的占空比。电外科单元10可连同流体以第三功率水平和/或第三波形(总称为第三、或止血密封RF能量设置)提供单极RF能量，以用于(通常低电压)止血或组织密封功能，其可与被提供到设备30用于切割功能或凝固功能的切割和凝固RF设置相同或不同。在一个示例中，止血密封能量可以被提供有连续的电流(100％的占空比)。标称阻抗可以在100到400欧姆范围之间以用于止血密封功能。在用于止血密封的90瓦特的功率设置处，电压可以从大约95到200伏特RMS范围。
在一个示例中，电外科单元10将RF能量提供到有效电极，作为具有在100KHz到10MHz范围中的频率的信号。通常，以脉冲串的形式施加该能量。每个串典型地具有在10微秒到1毫秒范围内的持续时间。在每个串中的单个脉冲通常各自具有0.1到10微秒的持续时间，其中脉冲之间的间隔为0.1到10微秒。实际的脉冲常常是正弦波或方波并且是交替的正和负幅值的双相。若干其他特征在Palanker等人的美国专利No.8,323,276中被描述。
电外科单元10包括用于开启和关闭单元的功率开关以及用于显示被供应到电外科设备30的RF功率的RF功率设置显示器。功率设置显示器可以在所选择的单元中数值上显示RF功率设置(诸如，瓦特)。
示例电外科单元10包括RF功率选择器，该RF功率选择器包括被用于选择或调整RF功率设置的RF功率设置开关。用户可以按下一个功率设置开关以增大RF功率设置以及按下另一个功率设置开关以减小RF功率设置。在一个示例中，功率设置开关是薄膜开关、软键或作为触摸屏的一部分。在另一示例中，电外科单元可包括不止一个功率选择器，诸如，与用在不同的功能中的不同的单极设置中的每个对应的功率选择器。
示例性电外科单元10还可以包括流体流速设置显示器和流速设置选择器。显示器可包括指示灯，并且流速选择器可以包括开关。按下流速开关中的一个选择流体流速，流体流速随后在显示器中被指示。
虽然不受特定的理论约束，但是流体流速Q(诸如，以每分钟立方厘米(cc/min)为单位)和RF功率设置PS(诸如，以瓦特为单位)的变量之间的关系可以被配置成抑制不期望的效应(诸如，组织干燥、电极粘着、烟的产生、炭的形成和其他的效应)，同时不提供在对应的RF功率设置PS处的组织处的流体流速Q不如此之大以致分散太多的电和/或过度地冷却在电极/组织表面处的组织。电外科单元10被配置成针对低、中和高的三个流体速度设置中的每一个随着增大的RF功率设置PS通常线性地增大流体流速Q。
电外科单元10可被配置成包括对泵22的控制。在这个示例中，可以基于输入变量(诸如，RF功率设置和流体流速设置)来预定泵22的速度以及流体吞吐量。在一个示例中，泵22可以与电外科单元10集成。
在以下专利中描述了若干电外科单元或发电机：例如2015年10月30日提交的Smith等人的题为“RF Output Stage Switching Mechanism”(RF输出级切换机制)的美国专利申请序列号No.14/927,999；2015年10月30日提交的Hubelbank等人的题为“FingerSwitch Circuitry to Reduce Leakage Current”(用于减少泄露电流的手指开关电路)的美国专利申请序列号No.14/928,020；2015年10月30日提交的Smith等人的题为“PowerMonitoring Circuitry and Method for Reducing Leakage Current in RFGenerators”(用于在RF发电机中减少泄露电流的功率监测电路和方法)的美国专利申请序列号No.14/927,969；以及McClurken的美国专利申请公开No.2006/0149225。
虽然参考电外科单元10和系统60的其他元件描述电外科设备30，但是应该理解，对该组合的描述是为了示出系统60的目的。可能的是，使用其他系统中的电外科设备30，或者电外科单元10可与其他电外科设备一起被使用。
图2示出具有多个单极电极组件100的电外科设备70的一个示例，其可以提供电外科设备30的一个示例。在示例中，电外科设备70多单极电极组件100包括：第一单极电极，该第一单极电极在示例中被配置为单极刀片102，该单极刀片102可操作用于以单极模式提供一个或多个功能(诸如，切割和凝固)；以及至少一个或多个单极电极104，该单极电极104可操作用于以单极模式提供包括使用分散的流体(诸如，流体12)对骨头和组织进行止血密封的附加的功能。
沿着纵轴A延伸的电外科设备70包括手持件80。手持件80包括把手82，把手82具有手指抓握部分84，该手指抓握部分84具有在设备70的下表面或底部B上所示的并旨在被持在外科医生手中的脊。在示例中，手持件80包括用于平衡的近端86并包括用于将线缆24电耦合到设备70的电连接器。
手持件80可被配置成使电外科设备70的用户能够像书写工具或电外科笔一样在拇指和食指之间持住并且操纵设备70。手持件80可包括可消毒的、刚性的、电绝缘材料，诸如，合成聚合物(例如，聚碳酸酯、丙烯腈-丁二烯-苯乙烯)。把手82可以包括与底部B相对的上表面或顶部T。在示例中，控制器88(诸如，一组被耦合到电路(诸如，在印刷电路板上)的一个或多个开关)被设置在顶部T上并且被配置成由用户的拇指或食指操作以激活电极组件100。
电外科设备70可以包括远离手持件80延伸的探头组件90。在示例中，探头组件90包括附连到轴94的主体部分92。轴94或电外科设备70的其他部分可包括一个或多个元件，该一个或多个元件形成将通常是刚性的、可弯曲的、长度固定的、长度可变的(包括可伸缩的或者具有轴向可延伸的或轴向可缩回的长度)或其他配置中的一个或多个的子组件。在Sylvester等人的美国专利申请公开No.2016/0120592中描述了具有可伸缩轴的电外科设备的示例。轴94将一个或多个电导体携载到包括电极组件100的远端96。电极组件100包括远侧尖端98。手持件80和探头组件90内的电路径可以被形成为导电的臂、线、迹线、其他的导电元件，以及由导电材料(诸如，可包括不锈钢、钛、金、银、铂或任何其他合适的材料的金属)形成的其他电路径。在示例中，轴94包括延伸进入手持件80的流体管腔以用于流体耦合到线缆26中的递送导管16。流体管腔包括被设置在电极组件100上的出口端口106以用于选择性地分散流体12。
在一个示例中，控制器88包括把手82上的与在电外科设备70内的用于提供针对每个功能的双态(binary)激活(开启/关闭)控制的的电路(诸如，PCB)组合的一个或多个按钮。例如，按钮88a可被按压以在切割功能中激活单极刀片102，另一按钮88b可被按压以在凝固功能中激活单极刀片102，并且又另一按钮88c可被按压以在密封功能和分散流体12中激活单极电极104并且从端口106分散流体。构想了控制器88以及其激活的替代配置。在一个示例中，当切割和凝固RF能量被提供给单极刀片102时，单极电极104不是活跃的(active)(并且流体没有从流体端口106被分散)，但是当止血密封RF能量被提供给单极电极104时，单极刀片102是活跃的。
当用于一个或多个模式的激活按钮被按下时，单极电极104可以被连接到单极刀片102。因为当单极刀片102是活跃的时候，单极电极104可以与组织接触，所以在一个示例中，单极电极104被配置成与电外科单元10的全输出电压隔离。同样，控制器88可以被配置成作出两个单独的接触，诸如，针对单极电极104的与高电压隔离的接触、以及针对控制器88的与低电压隔离的接触。
因此，控制器88可以提供受控制地作出和打破与一个或多个按钮88a、88b和88c的电连接的次序。传统的微开关可不提供隔离，并且使用双微开关即使一个具有充分的隔离也可在不正确的次序中被应用。为了克服这些挑战，控制器88可以包括圆顶(dome)开关以提供隔离和次序。圆顶开关用于低电压连接并且利用绝缘胶带(诸如，利用来自特拉华州威尔明顿市的杜邦(Dupont)的在商标名称Kapton下可购得的聚酰亚胺胶带)被粘附到控制器88的电路板。在圆顶开关上的胶带中提供孔以暴露金属底部。杆件(诸如导电弹簧)被定位在圆顶上方使得它撞击(strike)以胶带中的孔为中央的圆顶的暴露的金属。这个导电杆件随后经由电路板被电连接到单极电极104。绝缘按钮顶部(诸如，按钮88a、88b、88c中的一个)随后以这样的方式被放置在杆件和圆顶上：当用户按压按钮顶部时杆件首先被按压成与圆顶的顶部接触，从而将单极电极104电连接到单极刀片102。在一个示例中，在最初按压时对杆件小的力不将触觉反馈提供给用户。然而，当按钮顶部被进一步按压时，圆顶卡合并且作出第二接触，提供触觉反馈，并且连接激活线以将单极信号递送到电极组件100。当按钮顶部被释放时，这个过程反过来，并且在电极组件100被断开连接之前电外科单元10关闭。
虽然参考电外科设备70和系统60的其他元件来描述电极组件100，但是应该理解对组合的描述是为了示出具有电极组件100的电外科设备30的一个示例的目的。在其他的电外科设备中或与使用其他电外科单元的其他的系统一起使用电极组件100是可能的。
图3示出诸如电外科设备70之类的电外科设备的远端96的特写图。电极组件100远离轴94延伸。电极组件100包括：单极刀片102，该单极刀片102在示例中被配置为相对尖锐的、高阻抗的电极刀片以用于利用切割和凝固RF能量来切割和凝固组织，以及单极电极104，该单极电极104被配置为相对钝的、低阻抗的导体以用于利用被分散的流体使用止血密封RF能量来对组织和骨头进行止血密封。远侧尖端96还包括与导管16流体连通的流体端口106以用于分散流体12。在示例中，单极电极104包括流体端口106。单极刀片102经由电绝缘中间组件108与单极电极104间隔开并且电隔离。
图4示出电极组件100的示例。电极组件100可以包括被配置成被附连到轴94或者被设置在轴94内的尾部部分110，以及被配置成远离轴94延伸并且啮合组织的有效部分112。
在示例中，尾部部分110包括被电耦合到单极刀片102并且被配置成可操作地耦合到控制器88的一个或多个电导体(诸如，臂114a、144b)，以当被激活时向单极刀片102提供切割和凝固RF能量。尾部部分110还包括与流体端口106和导管16流体连通的海波管116以用于将流体12递送到有效部分112并且分散来自流体端口106的流体12。在示例中，海波管116是导电的或者包括可操作地耦合到电极104并且被配置成可操作地耦合到控制器88的导电部分(诸如线或迹线)以当被激活时向电极104提供止血密封RF能量。在示例中，海波管116与臂114a、144b电隔离。在一个示例中，臂114a、144b和海波管116可以使用线或其他的电引线在轴94中或电外科设备70中的其他位置经由点焊或其他的连接被电耦合到控制器88，以便将电能量从控制器88传导到电极组件100。海波管116和臂114a、144b利用中间组件108保持彼此间隔开。
中间组件108可以由绝缘材料(诸如，高温微模塑聚合物)形成。示例绝缘材料可以包括聚四氟乙烯(PTFE)、聚碳酸酯(PC)、聚甲醛(POM或乙缩醛)或聚醚醚酮(PEEK)。中间部分108包括定义边缘122和端部124的第一和第二侧表面120a、120b。示例的中间组件108包括圆形尖端126。
图5示出包括单极刀片102、单极电极104、海波管116和中间部分108的示例电极组件100的分解图。中间组件108包括被配置成接收单极电极104的孔径128。中间部分108还包括具有在端部124上的近侧开口132和在孔径128中的远侧开口134的、被配置成接收海波管116的孔130。中间组件108的边缘122包括被配置成接收并容纳单极刀片102的凹槽136。
图6示出沿线6－6所取得的图4的示例电极组件100的截面的俯视图。海波管116由适合用于盐水递送或其他合适的流体递送的医疗级材料的来配置。在一个示例中，海波管116也是导电的，或者包括导电部分(诸如，套管、迹线或线)并且可以由不锈钢进行构造。海波管116包括轴向延伸壁140，从而形成管腔142，并且包括在近端146上的入口144和在远端150上的出口148。近端146被配置成从中间部分108近侧地延伸，如图3中所指示的。壁140的近端146可以被耦合到手持件80内的流体管腔(未示出)以将入口144流体耦合到递送导管16以用于接收流体12进入海波管16。进一步地，壁140(或导电套管)的近端146可以被电耦合到控制器88以接收止血密封RF能量。壁140(或导电套管)的远端150可以被电耦合到单极电极104。
图4和5示出的电极组件100的有效部分112包括单极刀片102的切割刀片170和单极电极104。
单极电极104可以由导电材料(诸如不锈钢)形成。在示例中，单极电极104包括被设置在中间组件108的侧面120a、120b上的第一和第二主暴露导电表面160a、160b。主暴露导电表面160a、160b被配置成啮合组织和骨头以及递送止血密封RF能量。
图6示出主暴露导电表面160a、160b通常在轴向横向的导电棒164的任一端上的相对的盘162a、162b上彼此相对。在一个示例中，主暴露导电表面160a、160b通常与中间部件108的侧表面120a、120b齐平。在另一示例中，盘162a、162b从侧表面120a、120b纵向延伸。在所示的示例中，流体端口106在盘162a、162b和棒164内被形成，并且从第一主导电表面160a到第二主导电表面160b的延伸为开口。棒164在中间部件108的孔径128内被接收并且包括轴向延伸流体通道166。
海波管116的远端150在流体通道166处与棒164流体耦合。例如，流体通道166包括与海波管116的管腔142流体连通的入口168，并且流体通道包括与流体端口106流体连通的出口169，使得管腔142与流体端口106流体连通。流体12从递送导管16被传递到手持件80中和海波管116中，并且从海波管进入到棒164中，在棒164处流体12从主导电暴露表面160a、160b上的流体端口106被分散。
附加地，单极电极104被电耦合到海波管116的远端150以从控制器88接收止血密封RF能量。主导电暴露表面160a、160b具有相对大的表面区域以提供相对低的阻抗和低的电流密度以用于止血密封RF能量。
图4和5示出单极刀片102的切割刀片170可以与臂114a、114b整体地形成。切割刀片170包括围绕单极刀片102的周边176形成刀片边缘174的第一和第二主表面172a、172b。刀片边缘174可以是尖锐的或锥形的以进行机械地解剖并且电外科地切割和凝固组织。如图5中所指示的，单极刀片102可以是马蹄形的并且包括与在中间部件108的边缘122上的凹槽136连接的内部边缘178。
在示例中，切割刀片170由部分涂覆有绝缘体182以暴露邻近周边176的导电切割电极184的导电元件180形成。通过实现切割电极184，导电元件180和绝缘体182协作以形成坚固的、充分尺寸设计的切割刀片组件，该坚固的、充分尺寸设计的切割刀片组件具有在切割电极184处类似尺寸设计的完全暴露的金属刀片的导电表面区域的仅一小部分以减小热损伤区域的尺寸。因此，切割刀片170用作线束(harness)并且将单极能量进行聚焦，从而允许其生成等离子体，以用于以减小的功率、在切割电极184处的较高的电流密度、或者减小的功率和比在类似尺寸设计的完全暴露的金属刀片中可用的电流密度更高的电流密度的组合进行精确解剖和凝固。
导电元件180可以由金属(诸如，不锈钢或钛)形成，并且绝缘体182可由玻璃或陶瓷形成。在一个示例中，导电元件180由如在系列400不锈钢中的还很好地粘附于玻璃或陶瓷涂层的铁素体和马氏体铬合金形成。在一个示例中，导电元件180是系列420不锈钢。导电元件180可以用较大的金属片进行机加工、冲压或蚀刻。导电元件180可以在侧面172a、172b的一侧或两侧被磨成尖锐的、锥形的刀片边缘174。在一个示例中，暴露的导电切割电极184包括在大约1微米和100微米之间的厚度。在以下示例中，导电元件180可以通过将导电元件180浸在流体或熔融玻璃中并且随后在组装前对玻璃进行退火而被涂覆有玻璃或陶瓷绝缘体182，诸如，玻璃搪瓷绝缘体182。在一个示例中，绝缘体182具有暴露的导电切割电极184的厚度的大约一半和三倍之间的厚度。在一个示例中，单极刀片102的切割刀片170的宽度(如以从尾部114a到尾部114b的方向测量的)是单极刀片104的主表面160a、160b的直径的不止两倍。
在所示的示例中，单极刀片102包括被配置为切割刀片178的单个导电元件180。然而，在一些示例中，单极刀片102可以由多片导电材料形成并且包括分别提供切割和凝固功能的单独的电极，诸如，如Davidson等人的美国专利No.8,414,572中所描述的。
图7示出被配置用作海波管116以将流体12和RF能量从手持件80递送到单极电极104的示例海波管190。海波管180包括轴向延伸的中空导管192、近侧导电端子194(诸如，在近端150处)、远侧导电端子196(诸如在远端146处)、以及轴向延伸以将近侧导电端子194电耦合到远侧导电端子196的导电元件198。在示例中，近侧导电元件194和远侧导电端子196各自包括管腔以允许流体12流动使得当被耦合到海波管190时，流体端口106与导管16流体连通。此外，导电元件198将近侧导电端子194电耦合到远侧导电端子196使得控制器88与单极电极104电通信以当被激活时将止血密封RF能量提供给电极104。
在示例中，近侧导电端子194、远侧导电端子196、以及导电元件198由导电不锈钢进行配置。近侧导电端子194可以被配置成形成导管192上的可与导管16(诸如，通常被使用的柔性导管16，诸如，聚氯乙烯(PVC)导管16)配合的中空的倒钩状的装配件，以将流体12供应到电外科设备70或电极组件100。远侧导电端子196可以被配置成圆柱形导管，该圆柱形导管被部分地设置在导管192内并具有被耦合到棒164的远侧延伸端。近侧导电端子194可电耦合到控制器并且远侧导电端子196在入口168处可电耦合到棒164。
导管192可以由非导电材料(诸如，PVC、PEEK、或热塑性弹性体(TPE))进行构造。在一个示例中，TPE是来自法国科隆布的阿科玛(Arkema)的在商标名称PEBAX下可购得的聚醚嵌段酰胺(PEBA)。导电元件198可以在壁或导管192中形成或者可在导管192的管腔内从近侧导电元件194延伸到远侧导电元件196，诸如，管腔内的线。
图8示出示例海波管200，该示例海波管200通常与用于与例如电外科设备70一起使用的海波管190对应，该电外科设备70具有可选地可变长度的轴94，诸如，轴向可延伸或轴向可缩回的可伸缩轴，诸如以上所描述的美国专利公开No.2016/0120592的具有盐水冲洗线的可伸缩设备的示例。为了进行轴向转换，导管192和导电元件198是柔性的并且被盘绕成存储长度，以用于海波管200在可选地可变的长度轴内延伸并且可屈服地(yieldably)折叠，而在流体连通或电通信中没有松弛、不适当的应变或破裂。海波管200包括：包括远侧导电元件196的直线段202、包括近侧导电元件194的尾段204、以及缠绕成线圈的中间段206。导电元件198在海波管200的管腔内延伸。在一些示例中，直线段202可以被设置在轴94内并且中间段206的线圈可被设置在主体部分92或手持件80内。
在一些示例中，海波管200可以由PEBA导管的库存件(stock piece)形成。可以参考包括用于完全地延伸并且完全地折叠的长度的电外科设备70的尺寸来选择段202、204、206的长度。可以基于各种因素(诸如，导管的总尺寸、使用的材料、期望的线圈的刚度、在反复的延伸之后线圈变形的倾向)来选择用于形成和设置导管的时间和温度。
在制造电极组件100的一个示例中，单极刀片102、单极电极104、以及海波管116可以在单独的过程中被形成并且被接合在一起。海波管116和单极电极104可以被焊接在一起。与单极电极104接合的海波管116可以利用电绝缘材料包覆模制(overmold)以形成中间组件108。单极刀片102可以被附连到中间组件108。电极组件可以被电耦合到手持件80并且被附连到轴94。在一个示例中，电极组件可以被附连到电外科设备的轴和手持件，电外科设备诸如，从明尼苏达州明尼阿波利斯的美敦力先进能源公司(Medtronic AdvancedEnergy,LLC)可购得的在商标名称PEAK PlasmaBlade 3.0、Peak PlasmaBlade 4.0或类似的产品下销售的电外科设备。
虽然已参考优选实施例对本公开进行描述，但是本领域的技术人员将认识到可以作出形式或细节上的改变而不背离本公开的精神和范围。

Claims (15)

1.一种电外科设备，包括：
手持件，所述手持件具有控制器；以及
电极组件，所述电极组件从所述手持件延伸，包括：
单极刀片，所述单极刀片具有部分地涂覆有绝缘体并且被电耦合到所述控制器的导电元件以选择性地递送单极射频(RF)切割信号；以及
单极电极，所述单极电极与所述单极刀片间隔开并且电隔离，所述单极电极具有被电耦合到所述控制器的暴露的主导电表面以伴随被分散的流体选择性地递送单极RF止血密封信号。
2.如权利要求1所述的电外科设备，其特征在于，所述控制器被配置成选择性地将单极RF凝固信号递送到所述电极刀片。
3.如权利要求1所述的电外科设备，其特征在于，所述控制器包括第一按钮以选择性地递送所述RF切割信号以及第二按钮以选择性地递送所述RF止血密封信号。
4.如权利要求1所述的电外科设备，其特征在于，所述主导电表面包括所述流体端口以分散所述流体。
5.如权利要求1所述的电外科设备，其特征在于，包括海波管，所述海波管具有与所述流体端口流体连通、被配置成递送所述流体的导管以及与所述控制器以及被配置成递送所述单极RF止血密封信号的所述单极电极电通信的导电元件。
6.如权利要求1所述的电外科设备，其特征在于，所述控制器包括按钮以在将所述单极RF止血密封信号电耦合到所述单极电极之前将所述单极刀片电耦合到所述单极电极。
7.一种电外科设备，包括：
手持件；以及
电极组件，所述电极组件从所述手持件延伸，所述电极组件被配置成递送单极RF切割信号和单极RF止血密封信号，所述电极组件包括，
绝缘的中间组件，所述绝缘的中间组件具有主表面和边缘，
单极刀片，所述单极刀片被设置在所述中间组件的所述边缘上以递送所述单极RF切割信号，以及
单极电极，所述单极电极被附连到所述中间组件的所述主表面以伴随被分散的流体递送所述单极RF止血密封信号。
8.如权利要求7所述的电外科设备，其特征在于，所述单极刀片包括锥形切割边缘。
9.如权利要求8所述的电外科设备，其特征在于，所述单极刀片包括部分地涂覆有电绝缘涂层的导电元件。
10.如权利要求7所述的电外科设备，其特征在于，所述中间组件将所述单极刀片与所述单极电极进行电隔离。
11.一种电外科设备，包括：
手持件，所述手持件具有控制器；
轴，所述轴从所述手持件延伸出来，所述轴包括被配置成递送流体的海波管，所述海波管具有导电元件；以及
电极组件，所述电极组件从所述轴延伸，包括：
单极刀片，所述单极刀片具有部分地涂覆有绝缘体并且被电耦合到所述控制器的导电元件以选择性地递送单极射频(RF)切割信号；以及
单极电极，所述单极电极与所述单极刀片间隔开并且电隔离，所述单极电极具有经由所述导电元件被电耦合到所述控制器的暴露的主导电表面以经由所述海波管伴随被分散的流体选择性地递送单极RF止血密封信号。
12.如权利要求11所述的电外科设备，其特征在于，所述海波管包括与在所述主导电表面上的流体端口流体连通的非导电壁部分，并且所述导电元件被设置在所述管腔内。
13.如权利要求12所述的电外科设备，其特征在于，所述导电元件是线。
14.如权利要求13所述的电外科设备，其特征在于，所述海波管包括可延伸的且可屈服地折叠的线圈段。
15.如权利要求11所述的电外科设备，其特征在于，所述轴通常是刚性的并且具有固定的长度。
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