CN109561928A - 用于高级谐波能量的方法和系统 - Google Patents

用于高级谐波能量的方法和系统 Download PDF

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CN109561928A
CN109561928A CN201780049082.0A CN201780049082A CN109561928A CN 109561928 A CN109561928 A CN 109561928A CN 201780049082 A CN201780049082 A CN 201780049082A CN 109561928 A CN109561928 A CN 109561928A
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D·C·耶茨
A·M·克鲁姆
M·A·戴维森
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Angiotech Pharmaceuticals Inc
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Abstract

本公开的各方面呈现了一种医疗器械，该医疗器械被配置成能够调节用于密封规程的功率电平以考虑组织阻抗水平随时间的变化。在一些方面，医疗器械可被配置成能够当组织阻抗水平开始上升到“浴缸区域”之外时，根据功率算法施加功率，以通过随时间施加逐渐降低的功率值来密封组织，该“浴缸区域”是能量施加期间组织阻抗足够低以用于使电外科能量对密封组织有效的时间段。在一些方面，一旦组织阻抗水平超过“浴缸区域”，则切断功率。通过逐渐降低功率，在仍然施加用于密封的有效水平的功率与延长组织阻抗保持在“浴缸区域”中的时间之间实现平衡。

Description

用于高级谐波能量的方法和系统
技术领域
本公开整体涉及具有用于抓持和密封组织的各种机构的医疗装置。具体地，本公开涉及电外科器械，该电外科器械被配置成能够在执行密封规程时调控用于手术部位的能量的施加，以延长密封持续时间。
背景技术
电外科器械是一种在许多外科操作中使用的外科器械。电外科器械向组织施加电能以便对组织进行处理。电外科器械可包括具有安装在远侧的端部执行器的器械，该端部执行器包括一个或多个电极。端部执行器可抵靠组织定位，使得电流被引入到组织中。电外科器械能够被配置用于双极或单极操作。在双极操作期间，电流分别通过端部执行器的有源电极和返回电极被引入到组织中并从组织返回。在单极操作期间，电流通过端部执行器的有源(或源)电极被引入到组织中，并通过返回电极(例如，接地垫)返回，有源电极与返回电极分开位于患者的身体上。由流过组织的电流所产生的热可在组织内和/或在组织之间形成止血密封，并因此可尤其适用于例如密封血管。电外科器械的端部执行器有时还包括可相对于组织移动的切割构件以及用于横切组织的电极。
由电外科器械施加的能量可通过发生器传递至该器械。发生器可以形成电外科信号，该电外科信号被施加到电外科器械的一个或多个电极。发生器可以是电外科器械的外部或整体。电外科信号可以是射频(“RF”)能量的形式。例如，可以介于100kHz和1MHz之间的频率范围提供RF能量。在操作期间，电外科器械可将RF能量传递穿过组织，这会引起离子振荡或摩擦，并实际上造成电阻性加热，从而升高组织的温度。由于可在受影响的组织与周围组织之间形成尖锐边界，因此外科医生能够以高精确度水平进行操作，并在不损伤相邻的非目标组织的情况下进行控制。RF能量的低操作温度可适用于在密封血管的同时移除软组织、收缩软组织、或对软组织塑型。RF能量可尤其良好地适用于结缔组织，该结缔组织主要由胶原构成，并在接触热时收缩。在一些情况下，该器械还可被配置成能够施加超声能量以创建自稳态。发生器可被构造成能够传递能量，该能量在端部执行器处被转换成超声振动。传递到组织的能量可以类似地通过超声振动使电阻加热。
在向组织施加能量期间，组织的阻抗指示组织的状况。在施加一定量的能量之后，组织的阻抗急剧增加并降低了密封规程中施加的另外的能量的有效性。此外，随着组织阻抗接近该阈值水平，其中，施加的另外的能量不再有效，组织中的某些化学过程发生，期望得以更好地控制。组织响应于密封能量的时间段有时被称为“浴缸区域”，其基于组织有效地响应于密封能量的阻抗水平随时间的形状。因此，需要更好地控制组织中阻抗水平的上升，并延长组织在密封规程期间仍然响应(例如，延长“浴缸区域”)施加能量的时段。尽管已研制和使用了若干装置，但据信在本发明人之前还无人研制出或使用所附权利要求中描述的装置。
发明内容
在一些方面，提供了一种外科系统。
在一个方面，外科系统可包括：端部执行器，该端部执行器包括至少一个能量递送部件，该至少一个能量递送部件被构造成能够将多个不同功率电平(即，能量递送速率或能量递送水平)的电外科能量传递到手术部位处的组织；和控制电路，该控制电路通信地联接到能量递送部件并且被编程用于：在第一施加时段，使能量递送部件以第一功率电平或能量递送速率传递电外科能量，第一施加时段包括组织的阻抗达到最小值的时间点；在第一施加时段之后的第二施加时段，使能量递送部件以从第一功率电平降低的功率电平或能级速率传递电外科能量直到达到第二功率电平，第二功率电平低于第一功率电平，并且第二施加时段包括组织的阻抗上升到高于最小阻抗值的时间点；在第二施加时段之后的第三施加时段，使能量递送部件以第三功率电平传递电外科能量，第三功率电平低于第二功率电平，并且第三施加时段包括组织的阻抗上升到高于过渡阻抗阈值水平的时间点。
在外科系统的另一方面，第一施加时段和第二施加时段的组合包括电外科能量使手术部位处的组织密封的时间段。
在外科系统的另一方面，第三施加时段还包括组织的阻抗上升到一定水平，使得电外科能量不再使手术部位处的组织密封的时间段。
在另一方面，外科系统还包括至少一个传感器，该至少一个传感器被配置成能够测量组织中的初始阻抗水平和组织中的最小阻抗水平。
在外科系统的另一方面，控制电路还被编程用于基于测量的组织中的初始阻抗水平来确定第三施加时段的开始。
在外科系统的另一方面，控制电路还被编程用于基于测量的组织中的最小阻抗水平来确定第三施加时段的开始。
在外科系统的另一方面，第一施加时段和第二施加时段的组合包括组织阻抗保持低于组织中的初始阻抗水平的连续时间段。
在外科系统的另一方面，能量递送部件被构造成能够传递RF和超声能量。
在其它方面，提供了一种用于通过外科系统将电外科能量传递到手术部位处的组织的方法。该方法可包括：通过外科系统的能量递送部件将电外科能量施加到组织；通过外科系统的至少一个传感器测量组织的基准阻抗水平；基于测量的组织的基准阻抗水平来在多个功率负载曲线算法中确定用于能量递送部件的功率负载曲线算法；基于确定的功率负载曲线算法：在第一施加时段，使能量递送部件以第一功率电平传递电外科能量，第一施加时段包括组织阻抗达到最小值的时间点；在第一施加时段之后的第二施加时段，使能量递送部件以从第一功率电平降低的功率电平传递电外科能量直到达到第二功率电平，第二功率电平低于第一功率电平，并且第二施加时段包括组织的阻抗上升到高于最小阻抗值的时间点；在第二施加时段之后的第三施加时段，使能量递送部件以第三功率电平传递电外科能量，第三功率电平低于第二功率电平，并且第三施加时段包括组织的阻抗上升到高于过渡阻抗阈值水平的时间点。
在该方法的其它方面，确定功率负载曲线算法包括确定基准阻抗水平是否小于第一阈值阻抗值，基准阻抗水平是否大于第一阈值阻抗值并且小于第二阈值阻抗值，以及基准阻抗水平是否大于第二阈值阻抗值。
在该方法的其它方面，第一施加时段和第二施加时段的组合包括以较高的速率递送电外科能量并且使手术部位处的组织密封的时间段。
在该方法的其它方面，第三施加时段还包括组织的阻抗上升到一定水平，使得电外科能量以较低的速率递送，并且不再使手术部位处的组织密封的时间段。
在该方法的其它方面，基准阻抗水平是组织的最小阻抗值或初始阻抗水平。
在该方法的其它方面，第三施加时段的开始基于测量的基准阻抗水平。
在该方法的其它方面，第一施加时段和第二施加时段的组合包括组织阻抗保持低于组织中的初始阻抗水平的连续时间段。
在该方法的其它方面，能量递送部件被构造成能够传递RF和超声能量。
在其它方面，提供了一种外科器械。外科器械可包括：柄部组件；轴，该轴联接到柄部组件的远侧端部；端部执行器，该端部执行器联接到轴的远侧端部并且包括至少一个能量递送部件，该至少一个能量递送部件被构造成能够将电外科能量传递到手术部位处的组织；和控制电路，该控制电路通信地联接到能量递送部件并且被编程用于：在第一施加时段，使能量递送部件以第一能量水平传递电外科能量，第一施加时段包括组织的阻抗达到最小值的时间点；在第一施加时段之后的第二施加时段，使能量递送部件以从第一能量水平降低的能量水平传递电外科能量直到达到第二能量水平，第二能量水平低于第一能量水平，并且第二施加时段包括组织的阻抗上升到高于最小阻抗值的时间点；在第二施加时段之后的第三施加时段，使能量递送部件以第三能量水平传递电外科能量，第三能量水平低于第二能量水平，并且第三施加时段包括组织的阻抗上升到高于过渡阻抗阈值水平的时间点。
在外科器械的另一方面，第一施加时段和第二施加时段的组合包括电外科能量使手术部位处的组织密封的时间段。
在外科器械的另一方面，第三施加时段还包括组织的阻抗上升到一定水平，使得电外科能量不再使手术部位处的组织密封的时间段。
在另一方面，外科器械还包括至少一个传感器，该至少一个传感器被配置成能够测量组织中的初始阻抗水平和组织中的最小阻抗水平。
在其它方面，呈现了一种非暂态计算机可读介质。计算机可读介质可包括指令，该指令在由处理器执行时，使处理器执行包括前述方面中的任一个中描述的操作中的任一个的操作。
上述发明内容仅为例示性的，并非旨在以任何方式进行限制。除了上述例示性方面和特征，参考附图和下述详细说明，另外的方面和特征将变得显而易见。
附图说明
本文所述方面的新颖特征在所附权利要求书中进行了详细描述。然而，关于组织和操作方法的方面可结合如下附图参考下述说明更好地理解。
图1A示出了根据一些方面的外科器械系统的一个示例。
图1B示出了根据一些方面的外科器械系统的另一示例，在这种情况下示出了被配置成能够递送RF能量、超声能量或两者的组合的多种型式的外科器械。
图1C是电动外科装置的一个方面的侧面部分透明示意图。
图1D是电动外科装置的另一方面的侧面部分透明示意图。
图2示出了根据一些方面的钳口打开的端部执行器的透视图。
图3是描述根据一些方面的外科系统的功率源元件的另外的细节、外科器械联接到发生器的框图。
图4A提供了在手术期间经历密封规程的组织中存在的阻抗水平随时间变化的视觉描绘。
图4B提供了在手术期间经历密封规程的外科器械系统的各种电读数的另外的细节。
图5提供了随时间变化的组织阻抗水平的另一个示例，这次使用了更多的经验数据。
图6A示出了根据一些方面的由外科器械随时间施加到手术部位处的组织的电外科能量的示例性功率曲线，以便延伸或延长浴缸区域。
图6B示出了根据一些方面，作为施加到外科器械的经调节的功率的结果(诸如图6A中的示例性功率曲线)随时间变化的示例性经调节的阻抗曲线。
图7示出了图6A中引入的锥形负载曲线概念的示例性功率曲线，其具有叠加的附加功率特征。
图8提供了如何将多个负载曲线编程到外科器械中，以基于密封规程期间的阻抗测量值来施加不同功率调整的示例。
图9示出了根据一些方面的低最小阻抗阈值(参见图8)下的示例性负载曲线的视觉描绘。
图10示出了根据一些方面的中最小阻抗阈值(参见图8)下的示例性负载曲线的视觉描绘。
图11是阻抗阈值和最小脉冲持续时间的图形表示，示出了可以进行附加调整的示例，以改变功率来考虑其它组织特性。
图12是根据本发明的一个方面由大于325欧姆的阻抗阈值引起的电压减少的图示说明。
图13是根据本公开的一个方面的图11所示的图示说明的功率脉冲区域的图示说明。
具体实施方式
在以下详细说明中，参考构成其一部分的附图。在附图中，除非上下文另外指出，否则类似的符号和参考字符通常在几个视图中标识类似的部件。详细说明、附图和权利要求书中所述的例示性方面并非旨在为限制性的。可利用其它方面，并且可做出其它改变，此并不偏离此处所呈现的主题的范围。
下面对本技术的某些示例的说明不应用于限制本技术的范围。从下面的说明而言，本技术的其它示例、特征、方面和优点对于本领域的技术人员而言将变得显而易见，下面的说明以举例的方式进行，这是为实现本技术所设想的最好的方式中的一种。正如将意识到的，本文所述的技术能够具有其它不同的和明显的方面，所有这些方面均不脱离本技术。因此，附图和说明应被视为实质上是例示性的而非限制性的。
还应当理解，本文所述的教导内容、表达、方面、示例等中的任一个或多个可与本文所述的其它教导内容、表达、方面、示例等中的任一个或多个组合。因此，下述教导内容、表达、方面、示例等不应视为彼此孤立。参考本文的教导内容，本文的教导内容可进行组合的各种合适方式对于本领域的普通技术人员而言将显而易见。此类修改和变型旨在包括在权利要求书的范围内。
而且，在以下说明中，应当理解，诸如前、后、内部、外部、上部、下部等术语是方便的言语，并且不应当理解为限制性术语。本文所用的术语并非意在限制在本文所述装置或其部分的范围内，而是可以按照其它取向附接或利用。将参照附图更详细地描述各种方面。在整个公开内容中，术语“近侧”用于描述部件例如轴、柄部组件等的更接近于操作外科器械的使用者例如外科医生的侧面，并且术语“远侧”用于描述部件的距离操作外科器械的使用者更远的侧面。
本公开的各方面呈现了一种医疗器械，该医疗器械被配置成能够调节用于密封规程的功率电平，以考虑组织阻抗水平随时间的变化。通常在密封规程期间，存在一段时间，其中，组织阻抗水平足够低，以允许组织响应施加到其的能量。阻抗水平通常初始随时间略微下降，并且然后上升。在某一点之后，由于各种加热和化学因素，阻抗水平急剧上升，并且施加到组织的能量不再有效。在下面的附图中的一些中描述了在一系列负载上的任何功率源的限制的另外的示例细节。由于阻抗水平的初始下降和随后的缓慢上升，因此阻抗水平足够低以用于使施加的能量有效的时间段有时被称为“浴缸”区域。期望操纵施加到组织的功率电平以便延伸或延长该浴缸区域的长度，使得可延伸用于密封和操纵组织的时间段。
在一些方面，医疗器械可被配置成能够当组织阻抗水平开始上升到“浴缸区域”之外时，根据功率算法施加功率，以通过随时间施加逐渐降低量的功率来密封组织。在一些方面，一旦组织阻抗水平超过“浴缸区域”，则切断功率。通过逐渐降低功率，在仍然施加有效水平的密封功率与延长组织阻抗保持在“浴缸区域”中的时间之间实现平衡，这是由于功率降低。
本公开的医疗器械可包括附加特征结构。电外科装置的端部执行器可包括以各种构型布置的多个构件，以共同执行上述功能。如本文所用，端部执行器可被称为钳口组件或夹钳组件，其包括上钳口构件和下钳口构件，其中，上钳口构件和下钳口构件中的至少一者可相对于另一者移动。钳口构件中的每一个可适于连接到电外科能量源。每个钳口构件可结合电极。电极可以是正电极或负电极。在双极电外科装置中，电极可适于连接到电外科能量源的相对端子，诸如双极射频(RF)发生器，以便在它们之间产生电流。电外科能量可选择性地通过夹持在钳口构件之间的组织传输，以实现组织密封和/或治疗。组织可以在每个钳口构件上的相反极性电极之间流动的电流中凝结。
至少一个钳口构件可包括限定在该至少一个钳口构件中的刀通道，该刀通道被构造成能够使刀仅在那里往复运动，以切断夹持在钳口构件之间的组织。刀通道可以是钳口构件中的延伸狭槽。刀可设置在与至少一个钳口构件相关联的凹陷部内。电外科装置可具有凝结功能和切割功能两者。这可消除或减少手术期间的器械互换。可仅使用机械力或机械力和电外科能量的组合来实现切割。电外科能量可选择性地用于凝结和/或切割。刀可以由导电材料制成，该导电材料适于连接到电外科源，并且可选择性地激活以分离设置在钳口构件之间的组织。刀可以是弹簧偏置的，使得一旦切断组织，刀可以自动返回刀通道内的未接合位置或凹陷部中的回缩位置。
在一些方面，钳口构件可相对于彼此移动。在操作电外科装置期间，钳口构件中的至少一个可以从第一打开位置移动到第二闭合位置，在第一打开位置中，钳口构件可围绕大量组织设置，在第二闭合位置中，钳口构件抓持组织。因此，钳口构件可移动通过类似于传统钳子的抓紧器类的运动范围。在第二位置中，电流在钳口构件之间流动，以实现对其间捕获的组织止血。钳口构件可被构造成能够具有相对厚的近侧部分以抵抗弯曲。钳口构件中的至少一个可具有三维构型，其具有D形横截面。具有D形横截面的三维构型可抵抗弯曲。可包括锁定机构以将钳口构件锁定在闭合位置中。锁定机构可设定钳口构件之间的夹持压力。可在钳口构件之间设置至少一个导电间隙设定构件，以在双极电外科装置中的电极之间建立所需的间隙。
电外科装置可包括经由端部执行器抓持组织的部件、经由一个或多个电极向组织递送能量的部件、以及经由解剖装置诸如组织刀切割组织的部件。电外科装置的任何方面的结构能力可被设计用于多种外科规程中的一种或多种中。在一些外科规程中，附连到相对直的且不可弯曲的轴的端部执行器可容易地接近经治疗的组织。在一些另选的外科规程中，在此类轴上，端部执行器可能不容易地接近组织。在此类规程中，电外科装置可包括被设计成弯曲的轴，使得端部执行器可接触需要治疗的组织。在此类装置中，轴可包括一个或多个关节运动接头，其可允许轴在使用者的控制下弯曲。滑动刀可包括向滑动刀提供致动力的特征结构。刀致动器可以可操作地联接到轴以用于选择性地使刀通过刀通道往复运动。
前部组件可被设计用于特定的外科规程，而被构造成能够可释放地附接到前部组件的可重复使用的柄部组件可被设计成控制每个前部组件共有的外科功能，诸如组织抓持、烧灼和切割。因此，可减少手术所需的装置的数量和类型。可重复使用的柄部组件可被设计成使电外科装置的常见功能自动化。装置智能可由位于可重复使用的柄部组件中的控制器提供，该控制器被配置成能够从前部组件接收信息。此类信息可包括关于前部组件的类型和用途的数据。另选地，信息可包括指示控制部件(诸如可操纵的按钮或滑片)的位置和/或激活的数据，其可指示应激活哪些系统功能以及以何种方式激活。
在一些非限制性示例中，当能量激活控制被使用者置于激活位置中时，控制器可供应RF电流。在一些另选的非限制性示例中，一旦能量激活控制被置于激活位置中，控制器就可供应RF电流预先确定的时间段。在又一个非限制性示例中，控制器可接收与钳口的位置有关的数据，并且如果钳口未处于闭合位置，则防止RF电流被供应到一个或多个组织烧灼功率接触件。
在一些方面，所提到的示例中的任一个还可被构造成能够通过各种部件沿着至少一个轴线进行关节运动，该部件包括例如一系列接头、一个或多个铰链或挠性轴承、以及一个或多个凸轮或滑轮系统。其它特征结构可包括联接到端部执行器的构件中的一个或多个的相机或灯，以及用于外科装置的各种能量选项。
电外科装置可被配置成能够以各种形式获取能量，该能量包括但不限于电能、单极和/或双极RF能量、微波能量、可逆和/或不可逆电穿孔能量、和/或超声能量、热能、或它们的任何组合，以独立地或同时地输送到患者的组织。能量可通过与电外科装置电连通的功率源传递到电外科装置。功率源可以是发生器。功率源可经由合适的传输介质(诸如缆线)连接到电外科装置。功率源可与电外科装置分离，或者可与电外科装置整体地形成，以形成一体的电外科系统。在一个非限制性示例中，功率源可包括位于电外科装置的一部分内的一个或多个电池。应当理解，功率源可获取用于患者的组织上以及其它装置的任何其它电气用途的能量，该装置包括但不限于灯、传感器、通信系统、指示器和显示器，它们与电外科装置有关地和/或与电外科装置一起操作，以形成电外科系统。在一些方面，功率源可利用RF阻抗测量部分来获取用于测量组织效应的能量。然后可基于测量的组织效应来控制剩余的能量源，诸如超声能量。类似地，来自一个或多个源的多种类型的能量可组合，以用于以不同的方式相互作用。例如，具有RF能力和超声能力两者的器械可允许不同的能量类型在单个规程期间执行不同的功能。例如，RF能量可用于密封，而其它能量类型，诸如超声能量，可用于切割组织。通常，本公开可应用于具有组合元件的这些装置(例如，具有RF能量功能和超声能量功能两者的器械)，并且这些方面不限于此。类似的概念包括美国专利9,017,326“IMPEDANCE MONITORING APPARATUS,SYSTEM,AND METHOD FOR ULTRASONICSURGICAL INSTRUMENTS”中描述的系统和方法，其以引用方式并入本文。
电外科装置可被配置成能够以RF能量的形式获取电能。电外科装置可通过在两个或更多个钳口之间压缩的组织传递RF能量。此类RF能量可引起组织中的离子振荡，实际上产生电阻加热，并由此增加组织的温度。组织的温度升高可能导致组织烧灼。在一些外科规程中，RF能量可适用于在密封血管的同时移除软组织、收缩软组织、或对软组织塑型。RF能量可尤其良好地适用于结缔组织，该结缔组织主要由胶原构成，并在接触热时收缩。由于可在受影响的组织与周围组织之间形成尖锐边界，因此外科医生能够以高精确度水平进行操作，并在不损伤相邻的非目标组织的情况下进行控制。
RF能量可在EN 60601-2-2:2009+A11:2011，定义201.3.218-高频率中所述的频率范围内。例如，单极RF应用中的频率通常可被限制为小于5MHz。然而，在双极RF应用中，频率几乎可为任何值。单极应用通常可使用高于200kHz的频率，以便避免由于使用低频电流而导致不希望的对神经和肌肉的刺激。如果风险分析显示神经肌肉刺激的可能性已减轻至可接受的水平，则双极应用可使用较低频率。通常，不使用高于5MHz的频率以最小化与高频渗漏电流相关联的问题。然而，在双极应用的情况下，可使用较高的频率。通常认为，10mA是组织热效应的下限阈值。
如上所述，电外科装置可与发生器结合使用。发生器可以是电外科发生器，其特征在于固定的内部阻抗和固定的工作频率，其向外部负载(例如，组织)递送最大功率，诸如具有在约50欧姆至150欧姆范围内的电阻抗。在这种类型的双极电外科发生器中，当负载阻抗增加到数万欧姆或更高的水平时，随着负载阻抗朝着最大“开放电路”电压增加，施加的电压可单调增加。另外，电外科装置可与双极电外科发生器一起使用，该双极电外科发生器具有固定的工作频率和输出电压，该输出电压可在数十欧姆到数万欧姆的负载阻抗范围内基本上恒定，包括“开放电路”状态。电外科装置可有利地与可变电压设计或基本上恒定电压设计的双极电外科发生器一起使用，其中，当递送电流降低到预先确定的水平以下时可中断施加的电压。此类双极发生器可被称为自动发生器，因为它们可感测凝结过程的完成并终止电压的施加，常常伴有可听指示，其形式是停止“电压施加”音调或通知独特的“凝结完成”音调。此外，电外科装置可与电外科发生器一起使用，该电外科发生器的工作频率可随负载阻抗而变化，以作为随着负载阻抗的改变而调制施加的电压的部件。
电外科装置的各种方面使用治疗和/或亚治疗电能来治疗组织。一些方面可用在机器人应用中。一些方面可适用于手动操作的方式。在一个非限制性示例中，电外科装置可包括近侧柄部、远侧工作端部或端部执行器、以及设置在它们之间的导引器或细长轴。
有关电外科端部执行器、钳口闭合机构、以及电外科能量递送表面的附加细节在以下美国专利和已公布的专利申请中有所描述：美国专利7,087,054；7,083,619；7,070,597；7,041,102；7,011,657；6,929,644；6,926,716；6,913,579；6,905,497；6,802,843；6,770,072；6,656,177；和6,533,784；以及美国专利申请公布2010/0036370和2009/0076506中有所描述，所有这些专利和专利申请公布全文以引用方式并入本文并构成本说明书的一部分。
图1A示出了根据本公开的方面的外科器械系统100的一个示例。外科器械系统100包括电外科器械110。电外科器械110可包括近侧柄部112、远侧工作端部或端部执行器200，以及设置在它们之间的导引器或细长轴114。另选地，端部执行器可直接附接到柄部，如剪刀式装置，诸如美国专利7,582,087中描述的电外科器械。
电外科系统100可被配置成能够独立地或同时地向患者的组织供应能量，诸如电能、超声能量、热能、或它们的任何组合。在一个示例中，电外科系统100可包括与电外科器械110电连通的发生器120。发生器120可经由合适的传输介质(诸如缆线122)连接到电外科器械110。在一个示例中，发生器120可联接到控制器，例如诸如控制单元125。在各种方面，控制单元125可与发生器120整体地形成或者可作为电联接到发生器120(以虚线显示以示出此选项)的独立电路模块或装置而提供。控制单元125可包括自动或手动操作的控件，以控制由发生器120递送到电外科器械110的电流量。尽管如目前所公开的，发生器120被显示为与电外科器械110分开，但是在一些方面，发生器120(和/或控制单元125)可与电外科器械110整体地形成，以形成一体的电外科系统100，在该情况下，位于电外科器械110内的电池可以是能量源，而联接到电池的电路产生合适的电能、超声能量或热能。
在一个方面，发生器120可包括位于发生器120控制台的前面板上的输入装置。输入装置可包括生成适用于对发生器120的操作进行编程的信号的任何合适的装置，例如诸如键盘或输入端口。在一个示例中，第一钳口210a中的一个或多个电极以及第二钳口210b中的一个或多个电极可联接到发生器120。缆线122可包括多个电导体以用于将电能施加到电外科器械110的第一电极(其可被指定为+电极)和第二电极(其可被指定为-电极)。可以认识到，+和-标记仅仅是为了方便而不是指示电极性。导体中的每一个的端部可被放置成与发生器120的端子电连通。发生器120可具有多个端子，每个端子被构造成能够接触导体中的一个或多个。控制单元125可用于激活发生器120，该发生器可用作电源。在各种方面，发生器120可包括例如可被独立地或同时地激活的RF源、超声波源、直流电源、和/或任何其它合适类型的电能量源。
在各种方面，电外科系统100可包括至少一个供给导体131和至少一个返回导体133，其中，电流能够经由至少一个供给导体131供应至电外科器械110，并且其中，电流能够经由至少一个返回导体133流回发生器120。在各种方面，至少一个供给导体131和至少一个返回导体133可包括绝缘导线和/或任何其它合适类型的导体。如下文所述，至少一个供给导体131和至少一个返回导体133可包括在缆线122内和/或可包括：在发生器120与电外科器械110的端部执行器200之间或至少部分地在它们之间延伸的缆线。发生器120可被构造成能够在供给导体131与返回导体133之间施加足够的电压差，使得可将足够的电流供应到端部执行器200，以执行预期的电外科操作。
轴114可具有例如圆柱形或矩形横截面，并且可包括从近侧柄部112延伸的薄壁管状套管。轴114可包括延伸穿过其的镗孔，以用于承载用于致动钳口210a、210b的致动器机构(例如，可轴向移动的构件)，以及用于承载将电能递送到端部执行器200的电外科部件的电引线。近侧柄部112可包括钳口闭合触发器121，该钳口闭合触发器被构造成能够调节钳口210a、210b相对于彼此的位置。在一个非限制性示例中，钳口闭合触发器121可通过可操作地接合到钳口闭合触发器121的延伸部的梭动件联接到设置在轴114内的可轴向移动的构件。
端部执行器200可适于捕获并横切组织，并且适于同时通过能量(例如，RF能量)的受控施加而焊接所捕获的组织。第一钳口210a和第二钳口210b可闭合，从而捕获或接合组织。第一钳口210a和第二钳口210b还可对组织施加压缩。在一些方面，轴114连同第一钳口210a和第二钳口210b可旋转，例如完整的360°旋转。例如，旋钮148可能够围绕轴114的纵向轴线旋转，并且可联接到轴114，使得旋钮148的旋转致使轴114的对应旋转。第一钳口210a和第二钳口210b能够在旋转的同时保持为可打开和/或可闭合的。
图1还示出了刀推进控件140和位于近侧柄部112上的能量激活控件145。在一些非限制性示例中，刀推进控件140和能量激活控件145可以是可压低的按钮，其被定位成允许使用者通过使用一个或多个手指来控制刀推进或能量激活。
图1B示出了根据一些方面的外科系统10的第二示例，其包括发生器1002以及可与该发生器一起使用的各种外科器械1004、1006、1202。发生器1002可被构造用于与多种外科装置一起使用。根据各种形式，发生器1002可被构造用于与不同类型的不同外科装置一起使用，该外科装置包括例如超声装置1004、电外科装置或RF外科装置(诸如RF装置1006)以及集成了从发生器1002同时递送的电外科RF能量和超声能量的多功能装置1202。尽管在图1B的形式中，发生器1002被示出为与外科装置1004、1006、1202分开，但在一种形式中，发生器1002可与外科装置1004、1006、1202中的任一个整体地形成，以形成一体式外科系统。发生器1002包括位于发生器1002控制台的前面板上的输入装置1045。输入装置1045可包括产生适用于对发生器1002的操作进行编程的信号的任何合适的装置。
图1C示出了被构造成能够抓持和切割组织的外科装置900的一个方面。外科装置900可包括近侧柄部部分910、轴部分912和被构造成能够抓持组织的端部执行器914。近侧柄部部分910可以是本领域已知的任何类型的手枪式握持部或其它类型的柄部，其被构造成能够承载各种致动器，诸如致动器杠杆、触发器或滑块，它们被构造成能够致动端部执行器914。如图所示，近侧柄部部分910可包括闭合握持部920和固定握持部922。闭合握持部920朝向和远离固定握持部922的运动，诸如通过使用者的手的手动运动，可调节端部执行器914的位置。轴部分912可从近侧柄部部分910朝远侧延伸，并且可具有延伸穿过其的镗孔(未示出)。镗孔可承载用于致动端部执行器914的机构，诸如钳口闭合管和/或驱动轴。如下文进一步讨论的，一个或多个传感器(未示出)可联接到外科装置900，并且可被配置成能够感测可用于控制装置的马达932的输出的数据。
端部执行器914可具有多种尺寸、形状和构型。如图1C所示，端部执行器914可包括第一上钳口16a和第二下钳口916b，每个钳口设置在轴部分912的远侧端部912d处。上钳口916a和下钳口916b中的一者或两者可被构造成能够围绕端部执行器914的纵向轴线L1靠近或接近。钳口916a、916b中的两者均可相对于轴部分912移动，使得端部执行器914可在打开位置与闭合位置之间移动，或者仅有一个上钳口916a和下钳口916b可被构造成能够相对于轴部分912和钳口916a、916b中的另一个移动，以便使端部执行器914在打开位置与闭合位置之间移动。当端部执行器914处于打开位置时，钳口916a、916b可被定位成彼此隔开一定距离，它们之间具有空间。如下文进一步讨论的，组织可定位在钳口916a、916b之间的空间内。当端部执行器914处于闭合位置时，上钳口916a的纵向轴线可基本上平行于下钳口916b的纵向轴线，并且钳口916a、916b可朝向彼此移动，使得它们之间的距离小于端部执行器914处于打开位置时的距离。在一些方面，当端部执行器914处于闭合位置时，钳口916a、916b的面对接合表面919a、919b可彼此直接接触，使得其间的距离基本上为零。如图所示，上钳口16a被构造成能够相对于轴部分912并且相对于下钳口916b枢转，同时下钳口916b保持固定。如图所示，钳口916a、916b具有基本上细长且笔直的形状，但是本领域技术人员将理解，钳口916a、916b中的一个或两个可沿着端部执行器914的纵向轴线L1弯曲。至少当端部执行器914处于闭合构型时，端部执行器914的纵向轴线L1可与轴部分912的纵向轴线平行并且同轴，并且如果端部执行器914被构造成能够相对于轴部分912进行关节运动，则端部执行器914相对于轴部分912未进行关节运动。
图1D示出了外科装置1400的另一方面，该外科装置被构造成能够切割和密封夹持在装置的端部执行器1404的第一钳口1402a与第二钳口1402b之间的组织。装置1400可被构造成能够单独切割和密封组织并且被构造成能够同时切割和密封组织，其中，装置1400的使用者能够决定是否单独或同时进行切割和密封。装置1400通常可被构造成能够类似于图1C的装置900。装置1400可包括马达1406、闭合触发器1408、击发致动器1410、控制器1412、切割元件(未示出)、被构造成能够附接到外部功率源(未示出)的功率连接器(未示出)、能量致动器1414、从装置1400的柄部部分1418延伸的细长轴1416、传感器1420a,1420b、位于轴1416的远侧端部的端部执行器1404、固定柄部1424、和可能够操作地连接到马达1406并且被构造成能够将来自马达1406的输出传递到切割元件的齿轮箱1426。如图所示，控制器1412包括印刷电路板(PCB)，传感器1420a包括霍尔效应传感器，并且另一传感器1420b包括霍尔效应传感器。钳口1420a中的一个包括绝缘体1428，该绝缘体被构造成能够便于将安全能量施加到由端部执行器1404夹持的组织。如本领域技术人员将理解的，钳口1402a、1402b中的每一个可包括近侧狭槽1430a、1430b，其被构造成能够便于打开和闭合端部执行器1404。装置1400可被构造成能够将闭合触发器1408锁定在闭合位置中，诸如通过包括闩锁1432的闭合触发器1408，该闩锁被构造成能够当闭合触发器1408被拉得足够靠近时接合固定柄部1424上的对应闩锁1434，以便将闭合触发器1408相对于固定柄部1424锁定就位。闭合触发器闩锁1432可被构造成能够由使用者手动释放，以便解锁和释放闭合触发器1408。包括在柄部部分1418中的偏置弹簧1436可联接到闭合触发器1408并且当闭合触发器1408被解锁时使闭合触发器1408打开，例如，远离固定柄部1424移动。
图2示出了根据本公开的一个方面的端部执行器200的透视图，其中，钳口210a、210b打开。端部执行器200可附接到本文提供的各种外科器械中的任一种，包括被配置成能够向端部执行器200提供RF能量、超声能量或各种能量组合的那些器械。端部执行器200可包括第一钳口或上钳口210a以及第二钳口或下钳口210b，其可以是直的或弯曲的。上钳口210a可包括第一远侧端部212a和第一近侧端部214a。下钳口210b可包括第二远侧端部212b和第二近侧端部214b。当钳口210a、210b处于闭合构型时，第一远侧端部212a和第二远侧端部212b可被统称为端部执行器的远侧端部。第一近侧端部214a和第二近侧端部214b可被统称为端部执行器200的近侧端部。钳口210a、210b在第一近侧端部214a和第二近侧端部214b处枢转地联接。如图2所示，下钳口210b是固定的，而上钳口210a可相对于下钳口210b从打开位置枢转到闭合位置，并且反之亦然。在闭合位置中，第一远侧端部212a和第二远侧端部212b接近。在打开位置中，第一远侧端部214a和第二远侧端部214b间隔开。在其它方面，上钳口210a可以是固定的，并且下钳口210b可以是移动的。在其它方面，上钳口210a和下钳口210b两者可以是移动的。端部执行器200可包括位于端部执行器的近侧端部处或附近的枢轴组件270，该枢轴组件在端部执行器200的近侧端部处的钳口210a、210b之间的初始间隙处于闭合位置。枢轴组件270可在端部执行器200的制造期间在间隙设定过程中焊接就位，如下文更详细地描述的。
在一些方面，第一钳口210a和第二钳口210b可各自包括分别沿着其相应中间部分设置的细长狭槽或通道250a和250b。通道250a和250b的尺寸和构造被设置成适应轴向可移动构件(未示出)的运动，该构件可包括组织切割元件，例如，包括尖锐的远侧边缘。上钳口210a可包括第一能量递送表面230a。下钳口210b可包括第二能量递送表面230b。当钳口210a、210b处于闭合构型时，第一能量递送表面230a和第二能量递送表面230b彼此面对。第一能量递送表面230a可围绕通道250a以“U”形延伸，在第一远侧端部212a处连接。第二能量递送表面230b可围绕通道250b以“U”形延伸，在第二远侧端部212b处连接。第一能量递送表面230a和第二能量递送表面230b可包含导电材料，例如诸如铜、镀金的铜、银、铂、不锈钢、铝、或任何合适的导电生物相容性材料。例如，第二能量递送表面230b可连接到图1A所示的供给导体131，从而在电外科器械110中形成第一电极。第一能量递送表面230a可连接到图1A所示的返回导体133，从而形成电外科器械110的第二电极。例如，第一能量递送表面230a可接地。相反的连接也是可能的。
如图2所示，第二能量递送表面230b由沿着下钳口210b的主体的至少一部分设置或至少部分地设置的导电层形成。包括第二能量递送表面230b的导电层可延伸到第二远侧端部212b，并因此可在尚未实际抓持组织的情况下操作端部执行器200。下钳口210b还可包括布置在导电层与下钳口210b的主体之间的电绝缘层260。电绝缘层260可包括电绝缘材料，诸如陶瓷或尼龙。此外，第一能量递送表面230a由沿着上钳口210a的主体的至少一部分设置或至少部分地设置的导电层形成。上钳口210a还可包括布置在导电层与上钳口210a的主体之间的电绝缘层。
上钳口210a和下钳口210b可各自包括分别布置在第一能量递送表面230a或第二能量递送表面230b上的一个或多个电绝缘组织接合构件。电绝缘组织接合构件中的每一个可从能量递送表面突出并且在能量递送表面上方限定高度，并因此有时被称为“齿”。电绝缘组织接合构件可包括电绝缘材料，诸如陶瓷或尼龙。如图2所示，电绝缘组织接合构件240例如沿着下钳口210b的长度，从发送近侧端部214b到第二远侧端部212b以及在第二能量递送表面230b上纵向布置。如图2所示，电绝缘组织接合构件240成对，并且每对布置在通道250b的旁边并且由通道250b隔开。此处布置的这些成对的电绝缘组织接合构件240有时被称为“齿”。
在其它方面，电绝缘组织接合构件240的其它构型也是可能的。例如，电绝缘组织接合构件240可位于远离通道一定距离处。例如，电绝缘组织接合构件240可布置在能量递送表面上的网格中。在其它方面，电绝缘组织接合构件240可不具有如图2所示的半圆柱形横截面，并且可具有圆柱形横截面或矩形横截面。在其它方面，电绝缘组织接合构件240可布置在第一能量递送表面230a上，或者可布置在第一能量递送表面230a和第二能量递送表面230b中的两者上。
图3是根据一些方面的外科系统300的框图，该外科系统包括根据本公开的一些方面的马达驱动的外科抓持器械900、1400(图1C、图1D)，外科器械联接到发生器335(340)。在本公开中描述的马达驱动的外科切割和紧固器械2可联接到发生器335(340)，该发生器被构造成能够通过外部部件或内部部件向外科器械供应电力。图3描述了可如何将电外科能量递送到端部执行器的部分的示例。在某些情况下，马达驱动的外科器械110可包括联接到外部有线发生器335或内部发生器340的微控制器315。外部发生器335或内部发生器340可联接到A/C电源，或者可以是电池驱动的或它们的组合。例如，与马达驱动的外科器械110和/或发生器元件335、340相关联的电和电子电路元件可由控制电路板组件支撑。微控制器315通常可包括存储器310和可操作地联接到存储器310的微处理器305(“处理器”)。微控制器315可被配置成能够根据本文所公开的概念调控在端部执行器处施加的电外科能量并且在下面更详细地描述。处理器305可控制马达驱动器320电路，该电路通常用于控制马达325的位置和速率。马达325可被构造成能够控制能量到外科器械的端部执行器处的电极的传输。在某些情况下，处理器305可向马达驱动器320发送信号，以停止和/或停用马达325，如下文更详细地描述。在某些情况下，处理器305可控制单独的马达超控电路，该电路可包括马达超控开关，该马达超控开关可在外科器械的操作期间，响应于来自处理器305的超控信号而停止和/或停用马达325。应当理解，如本文所用的术语“处理器”包括任何合适的微处理器、微控制器，或者将计算机的中央处理单元(CPU)的功能结合在一个集成电路或最多几个集成电路上的其它基础计算装置。处理器是多用途的可编程装置，该装置接收数字数据作为输入，根据其存储器中存储的指令来处理输入，然后提供结果作为输出。因为处理器具有内部存储器，所以是顺序数字逻辑的示例。处理器的操作对象是以二进制数字系统表示的数字和符号。
在一些情况下，处理器305可以是任一种单核或多核处理器，诸如已知的由TexasInstruments生产的商品名为ARM Cortex的那些。在一些情况下，本公开的外科器械中的任一种可包括安全处理器，诸如例如包括两个基于微控制器的系列(诸如TMS570和RM4x)的安全微控制器平台(已知同样由Texas Instruments生产的商品名为Hercules ARM CortexR4)。然而，可不受限制地采用微控制器和安全处理器的其它合适的替代物。在一个示例中，安全处理器可被配置成能够专门用于IEC 61508和ISO 26262安全性至关重要的应用、以及其它应用，以提供先进的集成安全特征结构，同时递送可缩放的性能、连接性和存储器选项。
在某些情况下，微控制器315可以是例如购自Texas Instruments的LM4F230H5QR。在至少一个示例中，Texas Instruments LM4F230H5QR是ARM Cortex-M4F处理器内核，包括高达40MHz的256KB单周期闪速存储器或其它非易失性存储器的芯片上存储器310、高于40MHz的用于改善性能的预取缓冲器、32KB单周期串行随机存取存储器(SRAM)、加载有软件的内置只读存储器(ROM)、2KB电可擦除可编程只读存储器(EEPROM)、一个或多个脉宽调制(PWM)模块、一个或多个正交编码器输入(QEI)模拟、一个或多个具有12个模拟输入通道的12位模/数转换器(ADC)、以及随时可用于产品数据表的其它特征结构。可容易地取代其它微控制器以用于马达驱动的外科器械110。因此，本公开不应限于这一上下文。
再次参见图3，外科系统300可包括例如有线发生器335。在某些情况下，发生器335可被构造成能够在通过外部部件，诸如通过联接到外部发生器的电线供应电力。在一些情况下，外科系统300还可包括或另选地包括内部发生器340。内部发生器340可被构造成能够通过内部部件，诸如通过电池电源或其它存储的电容源来供应电力。下文描述了内部发生器340和有线发生器335的进一步描述。
在某些情况下，马达驱动的外科器械110可包括作为固件、软件、硬件、或它们的任何组合实现的一个或多个嵌入式应用程序。在某些情况下，马达驱动的外科器械110可包括各种可执行模块，例如诸如软件、程序、数据、驱动器和/或应用程序接口(API)。
参见图4A，曲线图400提供了在手术期间经历密封规程的组织中存在的阻抗水平随时间变化的视觉描绘。该示例性曲线图400提供了根据本公开所采用的功率调整类型的概念框架。此处，零时刻表示外科器械(诸如器械110)将电外科能量施加到手术部位处的组织的第一点。Y轴表示当经由器械110的端部执行器向组织施加基本上恒定的功率电平时存在的组织阻抗水平(Z)。在零时刻，组织表现出初始阻抗水平(Zinit)410。阻抗410的初始水平可基于关于组织的天然生理特性，诸如密度、水分量以及其是什么类型的组织。在短时间段内，已知阻抗水平实际上随着功率连续施加到组织而略微下降。这是在各种组织中发生的常见现象。最终达到最小阻抗水平(Zmin)420。从此处开始，阻抗的整体水平相应增加，并且首先随着缓慢上升而增加。最终，达到转变点，使得阻抗水平开始急剧上升到高于初始阻抗水平410。该点通常被称为过渡阻抗水平(Ztrans)430。在达到过渡阻抗430之后，阻抗水平随时间急剧上升，并且超过该点，组织阻抗通常对于电外科能量来说太高而不会对组织产生实质性影响。因此，电外科能量的终止440通常在达到过渡阻抗430点之后很快发生。因此，初始阻抗410与达到过渡阻抗430之间的时间段通常是电外科能量可以任何积极效果施加到组织的唯一有效时间。由于该时间段内曲线的大致形状，该区域有时被称为浴缸区域450。因此，期望延伸或延长浴缸区域450，以便增加可施加电外科能量的时间量。
参见图4B，曲线图450示出了被构造成能够向本公开的电外科系统提供电力的发生器的典型负载曲线的示例。左纵轴表示功率(W)和电压(V)，右纵轴表示电流(A)，并且横轴表示负载阻抗(欧姆)。电压曲线452、电流曲线454和功率曲线456被示出为负载阻抗的函数。如图所示，施加到组织的功率和电压的量通常达到了不可通过的阈值，即使在不断增加的负载阻抗下也是如此。从另一个角度来看，在手术部位处施加到组织的能量的量仅在至多某些水平的负载阻抗下具有明显的效果，并且在某个阻抗阈值(诸如175欧姆)之后，施加更多或持续的功率通常几乎没有益处。因此，曲线图450提供了关于为什么超过过渡阻抗阈值的其它细节，如曲线图400所示，通常表示应继续施加功率的截止点。
参见图5，曲线图500提供了随时间变化的组织阻抗水平的另一个示例，这次使用了更多的经验数据。如图所示，组织阻抗的水平保持相对低，直到达到过渡阻抗水平，在该示例中，这发生在四秒之后。在一些情况下，过渡阻抗水平由阻抗水平上升到高于最小阻抗水平值两倍的点限定，而在其它情况下，它可被限定为再次达到初始阻抗水平的点。无论使用何种定义，假设对组织施加恒定的功率电平，过渡阻抗水平通常在大约相同的时间发生。此外，已知过渡阻抗水平可靠地是组织的初始阻抗水平的函数。换句话讲，取决于阻抗的初始水平，可在组织中可靠地预测过渡阻抗水平。
参见图6A，曲线图600示出了根据一些方面的由外科器械110随时间施加到手术部位处的组织的电外科能量的示例性功率曲线，以便延伸或延长浴缸区域。连续的分段曲线610示出了功率电平在多个阶段中变化。最初，施加的电外科能量上升到预先确定的功率电平，诸如在这种情况下为20W。这表示用于所考虑的外科规程的初始期望功率电平。虽然组织阻抗通常在浴缸区域，但这种初始功率电平是可接受的。然而，随着组织阻抗开始改变并且朝向过渡阻抗水平上升，根据一些方面，功率电平以稳定速率渐缩，而不是像传统方法那样恒定地保持功率电平。在该示例中，假设过渡阻抗水平是200欧姆，并且可基于初始阻抗水平的测量值来确定。因此，当组织阻抗上升但在其达到过渡阻抗水平之前，诸如当组织阻抗达到过渡阻抗水平的75％(即150欧姆)时，外科器械110的功率系统可使功率电平以稳定的速率减小，如向下倾斜区域620所示。例如，在组织阻抗水平继续上升直到其达到过渡阻抗水平的过程中，功率电平可下降50％。最终，一旦达到过渡阻抗水平，可立马切断外科器械110的功率，因为超过过渡阻抗水平的功率的另外的施加可能是无效的，或者甚至可能对组织造成不希望的损害。在一些方面，可以多种方式实现功率的渐缩，这些方式均在本公开的范围内。例如，微处理器315(参见图3)可经由脉宽调控或通过经由驱动器320施加电阻的增加来调控来自发生器335或340的功率。通常，本公开可采用任何降低本领域技术人员已知的功率的方法，并且这些方面不限于此。
参见图6B，曲线图650示出了根据一些方面，作为施加到外科器械110的经调节的功率的结果(诸如示例性功率曲线610)随时间变化的示例性经调节的阻抗曲线。如图所示，由于根据本公开的方面进行的功率的渐缩，因此可使浴缸区域之外的阻抗上升更加平缓。另外，浴缸区域的总长度可延伸或延长。组织阻抗的逐渐上升还可允许在手术下更好地护理和治疗组织。通常，在达到过渡阻抗水平之后施加到组织的连续功率可能对组织造成不希望的损害，诸如烧伤组织、嘶嘶作响和爆裂。由于本文所公开的调整，因此可减少或甚至消除这种不期望的损害。
参见图7，曲线图700示出了图6A中引入的锥形负载曲线概念的示例性功率曲线，其具有叠加的附加功率特征。此处，如由粗线所示的曲线710表示作为组织中的负载阻抗的函数的电压的量度。如由中线所示的曲线720表示作为负载阻抗的函数施加到组织的计算的功率的量度。计算的功率可以是由外科器械110的功率系统确定的功率的量度，而如由虚线所示的曲线730表示施加到组织的实际或有效功率。如图所示，这些曲线中的两条表现出逐步减小的功率渐缩。这可能是由于功率随时间以不同的速率负载循环，即经由脉宽调制。如由细线所示的曲线740表示电流的量度。电流的刻度显示在右侧，而功率和电压的刻度显示在左侧。
如图所示，当负载阻抗被测量为约60欧姆至70欧姆时，在该示例中功率渐缩，并且当负载阻抗被测量为约100欧姆时，功率几乎完全被切断。在功率曲线的锥形区域期间电压急剧下降，但由于在负载阻抗持续增加的同时施加低但恒定的功率，电压开始再次缓慢上升。实际上，早在负载阻抗达到这些较高水平之前就会切断功率。
参见图8，在一些方面，外科器械110可被配置成能够基于手术部位处的初始组织阻抗的变化水平来施加不同的功率算法，以管理组织阻抗的上升。流程图800提供了如何将多个负载曲线编程到外科器械110中，以基于密封规程期间的阻抗测量值来施加不同功率调整的示例。例如，用于调节功率的算法可在框810处开始，其包括向端部执行器施加功率并且最终在手术部位处向所考虑的组织施加功率。在框820处，当端部执行器将电外科能量施加到组织时，可测量阻抗，并且可基于阻抗最终开始上升的点来确定最小阻抗。端部执行器可包括被配置成能够监视阻抗、电压或电流的一个或多个传感器，并且可应用多个数学公式来确定测量的阻抗是多少。对于可如何测量组织阻抗的各种示例描述于美国专利申请14/230,349和14/660,620中，其以引用方式并入本文。
在该示例中，基于测量的最小阻抗水平：低、中和高，可将三种不同的功率曲线应用于组织。在该示例中，在框830处，低最小阻抗阈值被限定为最小阻抗小于30欧姆时。在框840处，中最小阻抗阈值被限定为最小阻抗介于30欧姆和70欧姆之间时。在框850处，高最小阻抗阈值被限定为最小阻抗大于70欧姆时。基于测量的最小阻抗属于这三个类别中的一个，可根据三个特征调节负载曲线。例如，如果遵循低最小阻抗曲线，则可浴缸区域中的功率电平被设定为最大可用功率电平(例如，30W)，过渡阻抗阈值可被限定为比测量的最小阻抗大30欧姆，并且所有功率终止的阻抗可被设定为250欧姆。基于这三个特征，可生成功率负载曲线。在下文的图9和图10中可视地描绘了这些不同负载曲线的示例。又如，如果遵循中最小阻抗曲线，则可浴缸中的功率电平被设定为适中可用功率电平(例如，20W)，过渡阻抗阈值可被限定为比测量的最小阻抗大50欧姆，并且所有功率终止的阻抗可被设定为300欧姆。再如，如果遵循高最小阻抗曲线，则可浴缸区域中的功率电平被设定为低可用功率电平(例如，10W)，过渡阻抗阈值可被限定为比测量的最小阻抗大100欧姆，并且所有功率终止的阻抗可被设定为400欧姆。
在一些方面，不同于测量最小阻抗，而是可测量初始阻抗，并且可基于测量的初始阻抗水平来改变负载曲线。对于本领域技术人员显而易见的是，本文提供的示例可如何被修改以考虑被测量的初始阻抗水平，而不是被测量的最小阻抗水平。例如，过渡阻抗的计算可通过不同的因子来抵消，以考虑最小阻抗与初始阻抗之间的值的差异。另外，可遵循不同负载曲线的阈值(例如，框830、840和850)可基于根据初始阻抗的不同范围的修改标准。
医疗器械110中的功率系统可根据负载曲线向组织施加功率，这取决于选择的负载曲线。在所有情况下，功率系统可被配置成能够随着阻抗开始朝向过渡阻抗水平缓慢上升而渐缩功率和浴缸区域，这与图6A和图7所述的概念一致。
一旦医疗器械110已经根据负载曲线中的一条完成施加功率，则可在框860处执行终止规程。在一些方面，终止功率序列可基于在流程图800的先前框中设定了什么终止阻抗值。例如，可将一系列终止脉冲传递到医疗器械110的端部执行器。
参见图9，示出了根据一些方面的低最小阻抗阈值(参见图8)下的示例性负载曲线的视觉描绘。在该示例中，可能已经确定了最小阻抗是20欧姆，并因此过渡阻抗水平是50欧姆(即，比最小阻抗大30欧姆)。浴缸区域中的功率电平可被设定为最大水平，诸如30W。在达到过渡阻抗水平之后，功率电平可降至最小，并且一旦阻抗达到250欧姆(未示出)，可最终终止该功率电平。在一些方面，一旦达到过渡阻抗水平就立马切断功率电平，而在其它情况下，功率电平可渐缩以在达到过渡阻抗之前逐步减小。
参见图10，示出了根据一些方面的适中阻抗阈值(参见图8)下的示例性负载曲线的视觉描绘。在该示例中，可能已经确定了最小阻抗是50欧姆，并因此过渡阻抗水平是100欧姆(即，比最小阻抗大50欧姆)。浴缸区域中的功率电平可被设定为适中水平，诸如20W。在达到过渡阻抗水平之后，功率电平可降至最小，并且一旦阻抗达到300欧姆(未示出)，可最终终止该功率电平。在一些方面，一旦达到过渡阻抗水平就立马切断功率电平，而在其它情况下，功率电平可渐缩以在达到过渡阻抗之前逐步减小。
通常，这些示例所基于的示例性功率算法和概念可适于许多不同类型的电极构型，并且这些方面不限于此。各种示例包括各种长度和宽度的电极，包括比本文所示的示例更宽、更窄、更长或更短的电极；使用I形梁的电极；电动电外科系统(类似于本文所述的那些)；剪刀型电极；以及手持式夹钳类器械，无论是打开式、腹腔镜式还是机器人。本文所述的功率算法可通过调节如本文所示和所述的各种参数来设定和适应这些不同的场景。
图11是根据本公开的一个方面的阻抗阈值和最小脉冲持续时间的图示说明1100，其示出了可进行附加调整的示例，以改变功率来考虑其它组织特性。纵轴表示从左到右的电压(rms)、电流(rms)、功率(W)和阻抗(欧姆)/能量(J)，并且横轴表示时间。因此，电压曲线1102、电流曲线1104、功率曲线1106和阻抗/能量曲线1108被示出为叠加作为时间的函数。参见图11，图示1100示出了可进行改变功率的附加调整的示例，以便考虑其它组织特性。图示1100示出了随时间变化的示例性阻抗阈值和最小脉冲持续时间，以及对应的功率、电压和电流水平。在一些方面，根据一些方面，施加到组织的初始功率电平可基于附加因素，并且可改变功率调整以基于这些初始变化的功率电平来延长浴缸区域。例如，脂肪组织在密封期间趋于具有更高的阻抗。在将初始能量脉冲递送到组织之后，这些阻抗通常大于50欧姆。倘若不考虑这些组织特性，如果组织阻抗大于50欧姆，则组织将不会从发生器接收全功率。作为响应，将该阈值从50欧姆增加到125欧姆(参见图示1100中的圆圈1)可使发生器能够将全功率递送到基础肠系膜中，从而减少密封循环时间。在这种情况下，如果人体组织的电阻率大于125欧姆，则可能发生长的密封时间。因此，在其它情况下，该阈值可能需要增加到超过125欧姆。
关于最小脉冲持续时间，已经观察到，对于短180毫秒(ms)脉冲，阻抗(黑色曲线，例如，圆圈1内的曲线)趋于停止并且不会快速上升(参见圆圈2下时间跨度内该曲线的运动)。为了允许组织阻抗增加，可增加脉冲启动时间的持续时间。因此，在一些方面，对于复合负载曲线(CLC)表，最小脉冲宽度可从180ms增加到480ms。
图12是根据本发明的一个方面由大于325欧姆的阻抗阈值引起的电压减少的图示说明1200。如图所示，当组织阻抗接近300欧姆终止阻抗时，基于CLC表的电压曲线1102在60伏和100伏之间反弹(参见图示1100中的圆圈3)。该反弹导致阻抗上升速率减慢，如在反弹阻抗/能量曲线1108中可见。电压减少是由原始算法中编程的325欧姆阈值引起的。如果超过325欧姆阈值，则发生器被构造成能够将施加的电压从100伏减小到60伏。因此，本文描述的算法的一个方面不包括大于325欧姆的阻抗阈值。
图13是根据本公开的一个方面的图11所示的图示说明1100的功率脉冲区域的图示说明1300。在一个方面，该算法被配置成能够使得对于电压曲线1102的每个步骤，功率脉冲的持续时间是1秒。观察到在每个1秒脉冲的后半段期间，阻抗曲线1108的上升速率(斜率)将减小(参见图示1300中的圆圈4)。因此，在算法的一个方面，对于电压曲线1102的每个步骤，功率脉冲的持续时间减少到0.5秒，以防止阻抗轨迹在功率脉冲期间停止。根据功率脉冲的0.5秒持续时间，功率脉冲的数量从4减少到3(参见图示1300中的圆圈5)。每个功率脉冲的持续时间保持1秒。这允许较早完成的组织继续通过算法并因此更快地完成。
通常，本公开的方面可允许基于测量的手术组织中的阻抗水平对施加到手术部位处的组织的电外科能量的量进行各种类型的调整。例如，如果施加到手术组织的能量类型包括RF能量与超声能量，则所进行的功率算法不同。可能需要对负载曲线的各种特征进行调节，例如，最大功率电平可设定为什么，过渡阻抗应该设定为什么，能量何时终止，在什么水平阻抗功率应该开始渐缩等，这是由于组织可如何基于施加到其的不同类型的能量作出响应。但是，通常，功率曲线的大致形状应保持一致，并且基于测量的最小阻抗或初始阻抗，并且在一些方面还基于施加到组织的能量类型的各种其它特征，它可能只是确定应该为负载曲线的关键特征设定什么值。
在一些情况下，各种方面可实现为制造制品。制造制品可包括被布置成存储用于执行一个或多个方面的各种操作的逻辑、指令和/或数据的计算机可读存储介质。在各种方面，例如，制造制品可包括磁盘、光盘、闪速存储器或固件，这些制造制品包括适用于由通用处理器或专用处理器执行的计算机程序指令。然而，各方面并不仅限于此。
结合本文所公开的方面描述的各种功能性元件、逻辑块、模块和电路元件的功能可在计算机可执行指令的一般环境中实施，诸如由处理单元执行的软件、控制模块、逻辑、和/或逻辑模块。一般而言，软件、控制模块、逻辑、和/或逻辑模块包括被布置成执行特定操作的任何软件元件。软件、控制模块、逻辑、和/或逻辑模块可包括执行特定任务或实施特定抽象数据类型的例程、程序、对象、部件、数据结构等。软件、控制模块、逻辑、和/或逻辑模块和技术的具体实施可存储在某种形式的计算机可读介质上并且/或者通过某种形式的计算机可读介质传递。就此而言，计算机可读介质可以是可用于存储信息并且可由计算装置访问的任何可用介质。一些方面还可在分布式计算环境中实践，在该分布式计算环境中，操作由通过通信网络链接的一个或多个远程处理装置执行。在分布式计算环境中，软件、控制模块、逻辑和/或逻辑模块可位于包括存储器存储装置在内的本地和远程计算机存储介质两者中。
此外，应当理解，本文所述的方面阐明了示例性具体实施，并且功能性元件、逻辑块、模块和电路元件可以与所述方面一致的各种其它方式来实施。此外，由此类功能性元件、逻辑块、模块和电路元件执行的操作可组合和/或分离以用于给定的具体实施，并且可由更多数量或更少数量的部件或模块来执行。如本领域技术人员在阅读本公开之后所显而易见的，本文所述和所示的单独方面中的每一个具有分立部件和特征结构，在不脱离本公开的范围的前提下，该部件和特征结构可容易地与其它若干方面中的任一方面的特征结构分离或组合。可按所述事件的顺序或按任何其它在逻辑上可能的顺序来执行任何所述方法。
除非另外特别说明，否则应当理解，术语诸如“处理”、“运算”、“计算”、“确定”等是指计算机或计算系统、或类似电子计算装置的动作和/或过程，该电子计算装置诸如通用处理器、DSP、ASIC、FPGA或其它可编程逻辑装置、分立门或晶体管逻辑、分立硬件部件，或它们的任何组合，其被设计以执行本文所述的功能，其操纵表示为寄存器和/或存储器内的物理量(例如，电子)的数据并且/或者将其转换成类似地表示为存储器、寄存器或其它此类信息存储装置、传送装置或显示装置内的物理量的其它数据。
值得注意的是，一些方面可使用表达“联接”和“连接”以及它们的衍生词来描述。并不希望这些术语是彼此同义的。例如，一些方面可使用术语“连接”和/或“联接”来描述，以表示两个或更多个元件彼此直接物理接触或电接触。然而，术语“联接”还可指两个或更多个元件彼此不是直接接触，而是彼此配合或相互作用。就软件元件而言，例如，术语“联接”可以是指接口、消息接口、以及应用程序接口、交换消息等。
本文所公开的装置可被设计成在单次使用后废弃，或者其可被设计成多次使用。然而无论是哪种情况，该装置都可在至少使用一次后经过修整再行使用。修整可包括拆卸装置、之后清洁或替换特定零件以及后续重新组装步骤的任意组合。具体地，该装置可拆卸，而且可以任意组合选择性地替换或移除该装置的任意数目的特定零件或部件。在清洁和/或替换特定部件后，可对该装置进行重新组装，以便随后在修整设施处使用或就在外科手术之前由手术团队使用。本领域的技术人员将会理解，修整装置可利用多种技术来进行拆卸、清洁/替换和重新组装。此类技术的使用以及所得的修整装置均在本申请的范围内。
尽管本文已描述了各种方面，但可以实施并且本领域的技术人员将会想到这些方面的许多修改形式、变型形式、替换形式、改变形式和等效形式。另外，在公开了用于某些部件的材料的情况下，也可使用其它材料。因此，应当理解，上述具体实施方式和所附的权利要求旨在涵盖属于本发明所公开的方面的范围内的所有此类修改形式和变型形式。以下权利要求旨在涵盖所有此类修改形式和变型形式。

Claims (20)

1.一种外科系统，包括：
端部执行器，所述端部执行器包括至少一个能量递送部件，所述至少一个能量递送部件被构造成能够将电外科能量传递到手术部位处的组织；和
控制电路，所述控制电路通信地联接到所述能量递送部件并且被编程用于：
在第一施加时段，使所述能量递送部件以第一功率电平传递所述电外科能量，所述第一施加时段包括所述组织的阻抗达到最小值的时间点；
在所述第一施加时段之后的第二施加时段，使所述能量递送部件以从所述第一功率电平降低的功率电平传递所述电外科能量直到达到第二功率电平，所述第二功率电平低于所述第一功率电平，并且所述第二施加时段包括所述组织的阻抗上升到高于最小阻抗值的时间点；
在所述第二施加时段之后的第三施加时段，使所述能量递送部件以第三功率电平传递所述电外科能量，所述第三功率电平低于所述第二功率电平，并且所述第三施加时段包括所述组织的所述阻抗上升到高于过渡阻抗阈值水平的时间点。
2.根据权利要求1所述的外科系统，其中，所述第一施加时段和所述第二施加时段的组合包括以较高的速率递送所述电外科能量并且使所述手术部位处的所述组织密封的时间段。
3.根据权利要求1所述的外科系统，其中，所述第三施加时段还包括所述组织的所述阻抗上升到一定水平，使得所述电外科能量以较低的速率递送，不再使所述手术部位处的所述组织密封的时间段。
4.根据权利要求1所述的外科系统，还包括至少一个传感器，所述至少一个传感器被配置成能够测量所述组织中的初始阻抗水平和所述组织中的最小阻抗水平。
5.根据权利要求4所述的外科系统，其中，所述控制电路还被编程用于基于测量的所述组织中的初始阻抗水平来确定所述第三施加时段的开始。
6.根据权利要求4所述的外科系统，其中，所述控制电路还被编程用于基于测量的所述组织中的最小阻抗水平来确定所述第三施加时段的开始。
7.根据权利要求1所述的外科系统，其中，所述第一施加时段和所述第二施加时段的组合包括所述组织阻抗保持低于所述组织中的初始阻抗水平的连续时间段。
8.根据权利要求1所述的外科系统，其中，所述能量递送部件被构造成能够传递RF能量和超声能量。
9.一种用于通过外科系统将电外科能量传递到手术部位处的组织的方法，所述方法包括：
通过外科系统的能量递送部件使电外科能量施加到所述组织；
通过所述外科系统的至少一个传感器测量所述组织的基准阻抗水平；
基于测量的所述组织的基准阻抗水平来在多个功率负载曲线算法中确定用于所述能量递送部件的功率负载曲线算法；
基于确定的功率负载曲线算法：
在第一施加时段，使所述能量递送部件以第一功率电平传递所述电外科能量，所述第一施加时段包括所述组织的阻抗达到最小值的时间点；
在所述第一施加时段之后的第二施加时段，使所述能量递送部件以从所述第一功率电平降低的功率电平传递所述电外科能量直到达到第二功率电平，所述第二功率电平低于所述第一功率电平，并且所述第二施加时段包括所述组织的所述阻抗上升到高于最小阻抗值的时间点；
在所述第二施加时段之后的第三施加时段，使所述能量递送部件以第三功率电平传递所述电外科能量，所述第三功率电平低于所述第二功率电平，并且所述第三施加时段包括所述组织的所述阻抗上升到高于过渡阻抗阈值水平的时间点。
10.根据权利要求9所述的方法，其中，确定所述功率负载曲线算法包括确定所述基准阻抗水平是否小于第一阈值阻抗值，所述基准阻抗水平是否大于所述第一阈值阻抗值并且小于第二阈值阻抗值，以及所述基准阻抗水平是否大于所述第二阈值阻抗值。
11.根据权利要求9所述的方法，其中，所述第一施加时段和所述第二施加时段的组合包括以较高的速率递送所述电外科能量并且使所述手术部位处的所述组织密封的时间段。
12.根据权利要求9所述的方法，其中，所述第三施加时段还包括所述组织的所述阻抗上升到一定水平，使得所述电外科能量以较低的速率递送，并且不再使所述手术部位处的所述组织密封的时间段。
13.根据权利要求9所述的方法，其中，所述基准阻抗水平是所述组织的所述最小阻抗值或初始阻抗水平。
14.根据权利要求9所述的方法，其中，所述第三施加时段的开始基于所述测量的基准阻抗水平。
15.根据权利要求9所述的方法，其中，所述第一施加时段和所述第二施加时段的组合包括所述组织阻抗保持低于所述组织中的初始阻抗水平的连续时间段。
16.根据权利要求9所述的方法，其中，所述能量递送部件被构造成能够传递RF能量和超声能量。
17.一种外科器械，包括：
柄部组件；
轴，所述轴联接到所述柄部组件的远侧端部；
端部执行器，所述端部执行器联接到所述轴的远侧端部并且包括至少一个能量递送部件，所述至少一个能量递送部件被构造成能够将电外科能量传递到手术部位处的组织；和
控制电路，所述控制电路通信地联接到所述能量递送部件并且被编程用于：
在第一施加时段，使所述能量递送部件以第一功率电平传递所述电外科能量，所述第一施加时段包括所述组织的阻抗达到最小值的时间点；
在所述第一施加时段之后的第二施加时段，使所述能量递送部件以从所述第一功率电平降低的功率电平传递所述电外科能量直到达到第二功率电平，所述第二功率电平低于所述第一功率电平，并且所述第二施加时段包括所述组织的所述阻抗上升到高于最小阻抗值的时间点；
在所述第二施加时段之后的第三施加时段，使所述能量递送部件以第三功率电平传递所述电外科能量，所述第三功率电平低于所述第二功率电平，并且所述第三施加时段包括所述组织的所述阻抗上升到高于过渡阻抗阈值水平的时间点。
18.根据权利要求17所述的外科器械，其中，所述第一施加时段和所述第二施加时段的组合包括以较高的速率递送所述电外科能量并且使所述手术部位处的所述组织密封的时间段。
19.根据权利要求17所述的外科器械，其中，所述第三施加时段还包括所述组织的所述阻抗上升到一定水平，使得所述电外科能量以较低的速率递送，并且不再使所述手术部位处的所述组织密封的时间段。
20.根据权利要求17所述的外科器械，还包括至少一个传感器，所述至少一个传感器被配置成能够测量所述组织中的初始阻抗水平和所述组织中的最小阻抗水平。
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US20200030021A1 (en) 2020-01-30
CN109561928B (zh) 2021-08-24
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EP3493756B1 (en) 2020-12-09
EP3493756A1 (en) 2019-06-12
US11344362B2 (en) 2022-05-31
US20250090220A1 (en) 2025-03-20
US10376305B2 (en) 2019-08-13
US20180036065A1 (en) 2018-02-08
US20220346863A1 (en) 2022-11-03

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