CN110719758B - 用于减少粘附的rf电极上的图案化涂层的面积比率 - Google Patents
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Abstract
本发明提供了一种电外科系统,该电外科系统包括RF电流发生器、柄部主体和与该柄部主体以机械方式连通的端部执行器。该端部执行器具有包括第一电极的第一钳口,该第一电极具有与该发生器的第一端子电连通的第一电极表面。该端部执行器还包括第二钳口,该第二钳口包括第二电极,该第二电极具有与该发生器的第二端子电连通的基本上平坦的第二电极表面。该第一钳口包括至少一个特征部,该至少一个特征部被构造成能够向被压缩在该至少一个特征部和该第二电极表面之间的组织施加一定量的压缩力,该压缩力的量不同于当该第一钳口放置于邻近该第二钳口的位置时施加到压缩在该第一电极表面和该第二电极表面之间的该组织的压缩力的量。
Description
背景技术
在许多外科手术中使用电外科装置。电外科装置向组织施加电能以便对组织进行处理。电外科装置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。电外科装置可被构造用于双极操作。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。双极装置也可具有由两个或更多个钳口组成的端部执行器,每个钳口具有有源电极和/或返回电极中的至少一者。至少一个钳口能够从与相反钳口间隔开以用于接收组织的位置移动到钳口之间的空间小于第一位置的钳口之间的空间的位置。可移动钳口的移动压缩保持在其间的组织。由流过组织的电流所产生的热结合通过钳口移动实现的压缩可以在组织内和/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。电外科装置的端部执行器有时还包括能够相对于组织移动的切割构件以及用于横切组织的电极。
电外科装置还可包括将组织夹持在一起的机构诸如缝合装置,和/或切断组织的机构诸如组织刀。电外科装置还可包括超声振动刀片。电外科装置可包括轴,该轴用于将端部执行器邻近接受治疗的组织放置。轴可为直的或弯曲的、可弯曲的或不可弯曲的。在包括直的和可弯曲轴的电外科装置中,轴可具有一个或多个关节运动接头以允许轴的受控弯曲。当使用具有直的非弯曲轴的电外科装置不容易接近待处理的组织时,此类接头可允许电外科装置的使用者以与轴成角度的方式将端部执行器放置成与组织接触。
由电外科装置施加的电能可通过发生器传递至器械。电能可为射频(“RF”)能量的形式。电能可为在EN 60601-2-2:2009+A11:2011,定义201.3.218-高频率中所述的频率范围内的射频(“RF”)能量的形式。例如,单极RF应用中的频率通常被限制为小于5MHz。然而,在双极RF应用中,频率几乎可为任何值。单极应用通常使用高于200kHz的频率,以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,则双极技术可使用较低频率。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。但是,就双极技术而言可使用较高频率。
在其操作期间,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能量可以引起组织中的离子振荡,实际上造成电阻性(焦耳)加热,并由此增加组织的温度。密封过程中所涉及的温度可导致组织粘附到不锈钢电极。RF能量可对结缔组织和血管组织尤其良好地起作用,结缔组织和血管组织主要包含胶原蛋白和弹性蛋白,其在受热时液化并且在冷却时重新转变成熔融块。由于可在受影响的组织与周围组织之间形成不同热扩散边界,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。在许多外科手术中,RF能量可用于密封血管。
在组织的外科切除过程中,血管可作为手术的一部分或辅助切除所关注的组织。一旦血管被切断,血液就可能流入手术部位中,使部位从视野模糊并且使外科手术变得更加困难。如果切断的血管为主要血管,诸如动脉或静脉,则患者在手术过程中可能遭受大量失血,从而显著损害患者的健康。
应当理解,对血管的成功的基于电外科的密封需要施加足够的压缩力以闭合血管,电极之间的间隙一致,以及施加RF能量以在压缩下加热并密封组织。为了向血管施加足够的压缩力,在密封过程发生时,电外科装置的端部执行器钳口必须牢固地抓持血管并施加足够的压力以使血管壁近似于精确的间隙。
可以认识到,在压缩下施加RF能量以加热并密封组织可导致组织成分的变化,该变化可包括炭化或从受热组织形成凝结物。炭化的组织或凝结物可附着到端部执行器的一个或多个钳口,使得难以将密封的组织与端部执行器分离。在一些情况下,尝试手动将炭化的组织或凝结物与一个或多个钳口分离可导致组织密封破裂,从而引起手术部位出血。因此,设计具有能够允许密封的组织容易地从一个或多个端部执行器钳口释放的部件的电外科装置的端部执行器可能是有用的。
发明内容
在一个方面中,电外科系统可包括RF电流发生器、柄部主体和与柄部主体以机械方式连通的端部执行器,其中端部执行器可包括第一钳口,该第一钳口包括与RF电流发生器的第一端子电连通的第一能量递送表面,并且第二钳口包括与RF电流发生器的第二端子电连通的第二能量递送表面,其中第一能量递送表面的至少一部分包括不导电不粘材料的图案化涂层。
在电外科系统的一个方面中,第一能量递送表面具有第一区域,并且包括图案化涂层的第一能量递送表面的至少一部分具有第二区域。
在电外科系统的一个方面中,第二区域与第一区域的比率小于或等于约0.9。
在电外科系统的一个方面中,第二区域与第一区域的比率小于或等于约0.7。
在电外科系统的一个方面中,第二区域与第一区域的比率小于或等于约0.5。
在电外科系统的一个方面中,不导电不粘材料具有介于1100mJ/m2和5mJ/m2之间的表面能值。
在电外科系统的一个方面中,不导电不粘材料具有介于50mJ/m2和40mJ/m2之间的表面能值。
在电外科系统的一个方面中,不导电不粘材料具有介于40mJ/m2和12mJ/m2之间的表面能值。
在一个方面中,用于电外科装置的端部执行器可包括具有第一能量递送表面的第一钳口,该第一能量递送表面被构造成能够与RF电流发生器的第一端子电连通;和具有第二能量递送表面的第二钳口,该第二能量递送表面被构造成能够与RF电流发生器的第二端子电连通,其中第一能量递送表面的至少一部分包括不导电不粘材料的图案化涂层。
在端部执行器的一个方面中,第一能量递送表面具有第一区域,并且包括图案化涂层的第一能量递送表面的至少一部分具有第二区域。
在端部执行器的一个方面中,第二区域与第一区域的比率小于或等于约0.8。
在端部执行器的一个方面中,第二区域与第一区域的比率小于或等于约0.7。
在端部执行器的一个方面中,第二区域与第一区域的比率小于或等于约0.5。
在端部执行器的一个方面中,不导电不粘材料具有介于1100mJ/m2和5mJ/m2之间的表面能值。
在端部执行器的一个方面中,不导电不粘材料具有介于50mJ/m2和40mJ/m2之间的表面能值。
在端部执行器的一个方面中,不导电不粘材料具有介于40mJ/m2和12mJ/m2之间的表面能值。
在端部执行器的一个方面中,图案化涂层包括设置在第一能量递送表面中制造的一个或多个凹陷特征部内的不导电不粘材料。
在端部执行器的一个方面中,一个或多个凹陷特征部包括一个或多个圆形特征部。
在端部执行器的一个方面中,一个或多个凹陷特征部包括一个或多个矩形特征部。
在端部执行器的一个方面中,一个或多个凹陷特征部包括一个或多个线形特征部。
在端部执行器的一个方面中,一个或多个线形特征部沿着或平行于第一能量递送表面的纵向轴线设置。
在端部执行器的一个方面中,一个或多个线形特征部沿着或平行于第一能量递送表面的横向轴线设置。
在端部执行器的一个方面中,图案化涂层包括设置在第一能量递送表面的暴露表面上并与第一能量递送表面的暴露表面以直接物理方式连通的不导电不粘材料。
在端部执行器的一个方面中,图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个部分。
在端部执行器的一个方面中,不粘材料的部分包括不粘材料的一个或多个圆形部分。
在端部执行器的一个方面中,不粘材料的部分包括不粘材料的一个或多个矩形部分。
在端部执行器的一个方面中,不粘材料的部分包括不粘材料的一个或多个细长部分。
在端部执行器的一个方面中,第二能量递送表面的至少一部分包括设置在第二能量递送表面的暴露表面上并与第二能量递送表面的暴露表面以直接物理方式连通的不导电不粘材料的第二图案化涂层;并且其中当将第一钳口引入到邻近第二钳口的位置时,图案化涂层相对于第二图案化涂层在空间上偏移。
在端部执行器的一个方面中,第二能量递送表面具有第三区域,并且包括第二图案化涂层的第二能量递送表面的至少一部分具有第四区域。
在端部执行器的一个方面中,第四区域与第三区域的比率小于或等于约0.8。
在端部执行器的一个方面中,第四区域与第三区域的比率小于或等于约0.7。
在端部执行器的一个方面中,第四区域与第三区域的比率小于或等于约0.6。
在端部执行器的一个方面中,图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个细长部分,并且第二图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个第二细长部分。
附图说明
各个方面的特征在所附权利要求书中进行了具体描述。然而,通过结合如下附图参考以下说明可最好地理解关于组织和操作的方法的各个方面及其优点:
图1A示出了根据本公开的一个方面的与能量源电连通的外科器械。
图1B为根据本公开的一个方面的图1A所示的外科器械的端部执行器的详细视图。
图2示出了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的一个方面的透视图。
图3描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的第一方面。
图4描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的第二方面。
图5描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的第三方面。
图6描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的第四方面。
图7描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的第五方面。
图8描绘了组织对图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的粘附力的箱形图,其中第一钳口的表面可包括多个百分比的不粘材料涂层中的一种。
图9描绘了由图1A和图1B所描绘的电外科器械的端部执行器密封的组织的组织猝发压力的箱形图,其中第一钳口的表面可包括多个百分比的不粘材料涂层中的一种。
图10A-C描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的各方面,其描绘了具有不粘材料涂层的第一钳口的表面特征。
图10D描绘了图1A和图1B所描绘的电外科器械的端部执行器的第二钳口的顶视图的一个方面,其描绘了具有不粘材料涂层的第二钳口的表面特征。
图11描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的各方面,其中表面特征在图10A中示出,第一钳口包括多个百分比的不粘材料涂层。
图12描绘了图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的表面的各方面,其中表面特征在图10C和图10D中示出,第一钳口包括多个百分比的不粘材料涂层。
图13描绘了组织对图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的粘附力的箱形图,其中表面特征在图10A至图10D中示出,第一钳口包括多个百分比的不粘材料涂层。
图14描绘了由图1A和图1B所描绘的电外科器械的端部执行器密封的组织的组织猝发压力的箱形图,其中表面特征在图10A至图10D中示出,第一钳口包括多个百分比的不粘材料涂层。
图15描绘了主效应曲线图,来源于图13所描绘的组织对图1A和图1B所描绘的电外科器械的端部执行器的第一钳口的粘附力的箱形图。
图16描绘了穿过压缩在第一电极和第二电极之间的组织的RF电流路径,其中第一电极和第二电极的表面包括图案化不粘涂层。
具体实施方式
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。根据下面的描述,本技术的其他示例、特征、方面、方面和优点对本领域技术人员来说将变得显而易见。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、示例等中的任一者或多者可与本文所述的其他教导内容、表达、方面、示例等中的任一者或多者组合。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,诸如前部、后部、内部、外部、上部、下部、顶部、底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个方面。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。
针对单个电外科装置呈现了本公开的各方面,该单个电外科装置被构造用于抓持组织并使用电和/或其他能量执行密封规程。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能够相对于另一者移动。钳口构件可适于连接到电外科能量源。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反端子,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。组织可以因在钳口构件上的相反极性电极之间流动的电流而凝结。
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沿其往复运动,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。
在一些方面中,钳口构件能够相对于彼此移动。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带有D形横截面的三维构型。带有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。
电外科装置可结合用于在端部执行器的钳口之间设置间隙的部件、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能够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,端部执行器可能不能够容易地接近组织。在此类规程中,电外科装置可结合被设计成弯曲的轴,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部。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手术,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,该控制器被构造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构件的位置有关的数据,并且如果钳口构件未处于闭合位置,则防止RF电流被供应到一个或多个组织功率接触件。
在一些方面中,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。其它特征部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。
电外科装置可被构造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制成,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。
如上所述,电外科装置可被构造成能够以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构件之间压缩的组织传递RF能量。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、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。
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,其向具有在约1欧姆至约500欧姆范围内的电阻抗的外部负载(例如,组织)递送最大功率。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在数十欧姆到数万欧姆的负载阻抗范围内,包括“开放电路”状态下基本上恒定的输出电压、输出电流或输出功率中的任一者或多者。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。
电外科装置的各个方面使用治疗和/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。
在一些非限制性医学规程中,电外科装置可用于在组织切除之前焊接或密封血管。此类血管也可作为切除其他组织诸如囊肿、肿瘤或感染的材料的规程的一部分移除。血管密封可减少出血,从而降低切除规程中的潜在有害影响。在此类规程中,可在密封位置处切割血管。应当理解,在切割位点处可能需要完全密封以防止出血。因此,具有可防止切割血管直至确保完全密封的电外科装置是有用的。
为了适当地密封血管,可精确地控制影响密封的血管的厚度的两个机械参数:施加到血管的压力和电极之间的间隙。适当的密封可能需要在血管上施加足够的压力,以确保血管壁彼此邻近并且其间不存在居间间隙。可将血管压缩至预定范围内的压力。合适压力的典型范围可介于约30磅每平方英寸(约0.2MPa)和约250磅每平方英寸(约1.7MPa)之间。在一些另选的方面中,合适压力的范围可介于约250磅每平方英寸(约1.7MPa)和约1050磅每平方英寸(约7.2MPa)之间。此外,适当的密封可能需要提供足够的功率以确保血管壁接收足够的热以将壁焊接在一起。因此,可能需要组织压缩和足够的电外科装置功率两者来形成适当的密封。这些可通过端部执行器的钳口构件来实现。如上所述,钳口构件可抓持、压缩并将能量递送至组织。
为了有效地进行止血,钳口构件应有效地传导适当的电流流动穿过抓持的组织。当该电流不足时,组织或血管的凝结作用可能受到损害。当电流过大时,可能发生相应的过度加热,从而有可能产生破坏性的电弧。过度加热可导致组织和血液凝结物粘附到钳口构件的表面的现象。这可导致装置的电极与随后可为了治疗目的而被抓持的组织之间的电阻抗增大。这种粘附组织可引起凝固表面的破坏,其本身可损害预期的止血效果。端部执行器可结合高度抛光的电极表面,用于减少组织粘附的程度以及在发生粘附时有利于它们的清洁。
当抓持组织时,钳口构件可相互接触,从而导致短路。例如,当小组织部件在钳口构件之间被抓持和/或当钳口构件被用力压缩时,电极可在被抓持的组织附近彼此接触,从而导致短路。钳口构件可包括可在一些几何结构中接触的绝缘涂层。
在各个方面中,导电间隙设置构件可在钳口构件之间设置。导电间隙设置构件可固定在一个钳口构件上和/或与一个钳口构件成一整体并延伸至其他钳口构件。导电间隙设置构件可突出穿过钳口构件。导电间隙设置构件可限定钳口构件之间的间隙。导电间隙设置构件可以是导电的。间隙设置构件可由导电材料制成,并且还是刚性的以抵抗响应于所施加的力的变形。导电间隙设置构件的尺寸和构造可被设置为能够避免相反电极之间的短路和/或确保电极在电极之间不存在组织的情况下不会靠近到足以形成电弧。
在各个方面中,钳口构件的表面上的电极可由金属制成。钳口构件的表面的暴露部分可具有平滑表面以最小化对组织或凝结物的粘附,并且当组织碎屑或凝结物累积时有利于它们的清洁。钳口构件的表面可包括导热部件诸如铜、银、铝、钨、镍,或本领域的技术人员可能想到的任何其他导热材料。涂覆有生物相容性金属涂层的层压复合物可施加到表面。钳口构件可包括导热铜和机械强度更强的材料,尤其是更高模量的不锈钢的层压复合物。可通过电沉积的生物相容性金属涂层(诸如铬)保持钳口构件的生物相容性,该金属涂层涂覆有不锈钢和铜层压体两者同时不影响电绝缘构件。在一些非限制性示例中,对于具有小钳口构件的端部执行器(例如,在其尖端具有约0.039"(1mm)的宽度),可提供具有厚度为约0.011"的304不锈钢层和厚度为约0.052"的对应铜层的层压复合物。对于较大的钳口构件,可提供具有厚度为约0.015"的304不锈钢层和厚度为约0.075"至约0.085"的对应铜层的层压复合物。例如,可提供生物相容性涂层作为电沉积铬涂层,例如,由俄亥俄州克利夫兰市电解公司(Electrolyzing Corporation of Ohio,Cleveland,Ohio 44112)销售的MED-COAT 2000。该生物相容性涂层被描述为符合或超过USP类VI级认证。
在各个方面中,钳口构件的长度可被设置用于外科手术中的特定应用。例如,长度为约0.4"或0.5"至约0.75"诸如约0.47"(12mm)的钳口构件可用于较小的解剖结构或精细的工作。对于较大的解剖结构,钳口构件的长度可为约1"或更大,例如约1.57"(40mm)。
如上所述,钳口构件的表面的暴露部分可具有平滑表面以最小化对组织或凝结物的粘附,并且当组织碎屑或凝结物累积时有利于它们的清洁。钳口构件的表面可包括导热部件诸如铜、银、铝、钨、镍,或本领域的技术人员可能想到的任何其他导热材料。涂覆有生物相容性金属涂层的层压复合物可施加到表面。钳口构件可包括导热铜和机械强度更强的材料,尤其是更高模量的不锈钢的层压复合物。可以认识到,即使对于具有平滑表面的钳口构件,组织或凝结物仍可附着到这些钳口构件。因此,可能难以将密封的组织从钳口构件移除,以允许端部执行器从一个位置移动到另一个位置。从钳口构件手动移除此类组织或凝结物可对由电外科装置产生的组织的密封质量产生不利影响。
在一些方面中,不粘金属涂层可包括可用于降低或防止其他材料粘附到金属表面的能力的涂层,例如可用于降低或防止煎鸡蛋粘附到涂覆有不粘材料的锅的涂层。此类不粘涂层的特性可包括低表面能值。表面能值可用于量化在表面形成时发生的分子间键的破坏。因此,表面能可被视为材料表面处与整体相比的多余能量,或构建特定表面区域所需的功。另一种观察表面能的方法是将其与切割整体样本所需的功联系起来,从而形成两个表面。表1呈现了一些材料的表面能的一些示例性值。
表1
样本材料的表面能
材料 | 表面能(mJ/m<sup>2</sup>) |
铜 | 1103 |
铝 | 840 |
锌 | 753 |
不锈钢 | 700-1100 |
氧化铝-蓝宝石 | 638 |
锡 | 526 |
铅 | 458 |
二氧化硅-硅石 | 287 |
玻璃/瓷 | 250-500 |
云母 | 120 |
聚酰亚胺 | 46 |
聚氯乙烯 | 42 |
脂族或半芳族聚酰胺 | 41 |
聚苯乙烯 | 40 |
聚乙烯 | 32 |
聚四氟乙烯 | 18 |
聚六氟丙烯 | 12 |
为了进行比较,不锈钢通常可具有约700mJ/m2(dyne/cm)至约1000mJ/m2(dyne/cm)的表面能值,其促进低附着力(低附着力导致低粘附)。然而,不粘材料可具有约50mJ/m2至约40mJ/m2的表面能值。不粘材料的此类表面能值的非限制性示例可包括值为约50mJ/m2、约48mJ/m2、约46mJ/m2、约44mJ/m2、约42mJ/m2、约40mJ/m2,以及任何值或包括端点在内的值的范围。此类不粘材料可包括普通聚合物,诸如脂族或半芳族聚酰胺(例如尼龙)和聚酰亚胺(例如,)。可以认识到,此类聚合物的表面能值远低于例如不锈钢的表面能值,并且因此可能较不易粘附。具有甚至更低表面能值—例如,在约40mJ/m2至约12mJ/m2的范围内—的其他材料可甚至更抗粘附。不粘材料的此类表面能值的非限制性示例可包括值为约40mJ/m2、约36mJ/m2、约32mJ/m2、约28mJ/m2、约24mJ/m2、约20mJ/m2、约16mJ/m2、约12mJ/m2,以及任何值或包括端点在内的值的范围。聚四氟乙烯(PTFE)是此类材料的一种,具有约18mJ/m2的表面能。还有可具有甚至更低的表面自由能值的其他材料,诸如具有可利用“荷叶效应”的表面微结构和/或纳米结构的那些材料。天然的或人造的此类材料可具有约5mJ/m2的表面自由能值。因此,在一些非限制性方面中,不粘材料可为具有小于不锈钢的表面能的非零、正值表面能的材料。例如,不粘材料可具有小于约1100mJ/m2至约5mJ/m2的表面能。因此,在一些一般的非限制性示例中,不粘材料的此类表面能值可包括值为约1100mJ/m2、约1000mJ/m2、约900mJ/m2、约800mJ/m2、约700mJ/m2、约600mJ/m2、约500mJ/m2、约400mJ/m2、约300mJ/m2、约200mJ/m2、约100mJ/m2、约50mJ/m2、约40mJ/m2、约30mJ/m2、约20mJ/m2、约10mJ/m2、约5mJ/m2,以及任何值或包括端点在内的值的范围。
此类不粘涂层可以是导电的或不导电的。导电不粘涂层可充分导电,以允许电流穿过电外科装置的钳口所接触的组织,以实现局部加热和组织密封。然而,涂覆有不导电涂层的钳口构件的部分将不允许电流穿过组织。可能怀疑的是,随着涂覆的表面积的量增加,组织对具有不粘表面涂层的钳口构件的粘合(粘附)力的量可减小。然而,也可能怀疑的是,对于完全或几乎完全涂覆有不导电不粘材料的钳口构件,可能与密封质量有关的组织密封的量可显著减少。
然而,此类不粘表面涂层对基于电外科的血管密封的质量的影响尚未明确确定。以下公开了不导电不粘涂层的量对基于电外科的血管密封的质量的影响的受控测试的结果。此类测试既测量组织对钳口构件的粘合力,又测量组织内产生的基于电外科的血管密封的有效性。此类测试揭示了意想不到的结果,即将甚至高百分比(大于70%)的表面涂覆不导电不粘材料的钳口构件可产生基于电外科的血管密封,这些血管密封在功能上等同于由未涂覆涂层的钳口构件形成的那些血管密封。先前未见过的额外的测试进一步揭示了不同涂层几何形状对粘合力和基于电外科的血管密封质量两者的有效性。此类测试的结果表明了额外的意想不到的结果,即组织基于电外科的血管密封的功效还可取决于钳口构件上涂层的几何形状,而不仅仅取决于涂覆有不粘材料的表面的量。
就本公开而言,术语“图案化涂层”被定义为表面上的材料涂层,其中图案由一个或多个几何部件限定,并且图案化涂层被具体地制造成包括一个或多个几何部件。在该定义中,术语“具体制造”被认为是指图案是有意设计的,并且图案化涂层的制造方法可在任意数量的表面上重复或潜在地重复。还应当理解,图案化涂层可包括包含从材料移除的一个或多个部分的材料涂层,图案化涂层可包括施加到表面的涂层材料的部分的图案,或者图案化涂层可通过包覆模制工艺制造。
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。
图1A示出了根据本公开的一个方面的与发生器101电连通的电外科器械100。根据各个方面,电外科器械100能够利用柔性电路102进行构造。电外科器械100可包括细长构件103,诸如轴104,其具有联接到柄部组件106的近侧部分105。细长构件103的远侧部分107可包括联接到轴104的远侧端部的端部执行器108(参见1B图)。在一些方面中,端部执行器108可包括第一钳口构件109a和第二钳口构件109b,每个钳口构件均具有外部部分或表面110a、110b。第一钳口构件109a和第二钳口构件109b中的至少一者可相对于轴104移动。可仅有一个钳口能够相对于轴104移动,并且另一个钳口可相对于轴104固定。第一钳口构件109a和第二钳口构件109b中的至少一者可相对于另一者沿箭头J所示的路径可旋转地移动以使第一钳口构件109a和第二钳口构件109b在打开位置和闭合位置之间转换。在操作中,第一钳口构件109a和第二钳口构件109b可从打开位置转换到闭合位置以捕获两者之间的组织。捕获的组织可接触钳口组111a、111b的一个或多个工作部分,所述一个或多个工作部分被构造成能够施加能量以治疗定位在端部执行器108处或附近的目标组织。
能量的类型可采取各种形式,并且包括但不限于单极性和/或双极性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,或它们的任何组合。柄部组件106可包括限定夹持件113的外壳112。在各个方面中,被构造成能够向端部执行器108提供操作指令的柄部包括一个或多个控制界面114a-c,例如,按钮或开关114a、能够沿着箭头R旋转的旋钮114b,和能够相对于夹持件113沿着箭头T移动的触发器114c。所述多个按钮、旋钮或触发器也可被包括为外壳112的一部分,以便操纵端部执行器108处的一个或多个功能构件。在一些方面中,柄部组件106还可被构造成能够电联接到发生器101以向电外科器械100提供能量。
发生器101可经由合适的传输介质诸如缆线115连接到电外科器械100。在一个示例中,发生器101可联接到控制器,例如控制单元116。在各个方面中,控制单元116可与发生器101整体地形成或者可作为电联接到发生器101(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116可包括自动或手动操作的控件,以控制由发生器101递送到电外科器械100的电流量。尽管如目前所公开的,发生器101被显示为与电外科器械100分开,但是在一些方面中,发生器101(和/或控制单元116)可与电外科器械100整体地制成,以形成一体的电外科系统,在该情况下,位于电外科器械100内的电池可以是能量源,并且联接到电池的电路产生合适的电能、超声能量或热能。虽然发生器101通常被示出为联接到柄部组件106(例如,用细绳),但应当理解的是在一些方面中,发生器101可定位在细长构件103和/或柄部组件106内。例如,在一个方面中,发生器101包括定位在柄部组件106、轴104或其一部分中的一个或多个直流电池。
在一个方面中,发生器101可包括位于发生器101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101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109a中的一个或多个电极以及第二钳口109b中的一个或多个电极可联接到发生器101。缆线115可包括多个电导体以用于将电能施加到电外科器械100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101的端子电连通。发生器101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116可用于激活发生器101,该发生器可用作电源。在各个方面中,发生器101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/或任何其他合适类型的电能量源。在各个方面中,缆线115可包括至少一个供给导体117和至少一个返回导体118,其中,电流能够经由至少一个供给导体117供应至电外科器械100,并且其中,电流能够经由至少一个返回导体118流回发生器101。在各个方面中,至少一个供给导体117和至少一个返回导体118可包括绝缘导线和/或任何其他合适类型的导体。如下文所述,至少一个供给导体117和至少一个返回导体118可包括在缆线115内和/或可包括:在发生器101与电外科器械100的端部执行器108之间或至少部分地在它们之间延伸的所述缆线。发生器101可被构造成能够在供给导体117与返回导体118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108,以执行预期的电外科操作。
在一个示例中,发生器101可实施为电外科单元(ESU),该电外科单元能够提供足以利用射频(RF)能量来执行双极电外科手术的功率。在一个示例中,ESU可为由科罗拉多州博尔德市的美敦力公司(Medtronic of Boulder Colorado)出售的Force TriadTM能量平台。在一些方面中,诸如对于双极性电外科应用而言,可利用具有有源电极和返回电极的电外科器械100,其中有源电极和返回电极可抵靠、邻近待处理的组织来定位和/或与待处理的组织电连通,使得电流可从有源电极流动通过组织并且流到返回电极。因此,在各个方面中,电外科系统可包括供给路径和返回路径,其中正被处理的所捕获组织完成或闭合电路。在其他方面中,发生器101可提供亚治疗RF能级以用于在电外科系统中评估组织状态以及提供反馈的目的。可使用此类反馈来控制电外科器械100的治疗性RF能量输出。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,则双极外科手术可使用亚治疗RF能级。在某些情况下,可不使用高于5MHz的频率以最小化与高频渗漏电流相关联的问题。然而,就双极技术而言可使用较高频率。
在电外科器械100的操作过程中,使用者通常抓持组织,向抓持的组织提供能量以形成焊接或密封(例如,通过致动按钮和/或踏板),并且然后驱动电外科器械的远侧端部处的组织切割元件穿过抓持的组织。根据各个方面,可提供钳口闭合构件,并且钳口闭合构件的轴向运动的平移可为有节奏的或以其他方式受控制的,以有助于以合适的行进速率来驱动钳口闭合构件。通过控制行进速率,所捕获组织在经切割元件横切之前已被适当地和功能性地密封的可能性可能会增加。
图2为外科器械系统100的第一钳口构件109a的一个示例的透视图。第一钳口构件109a可包括至少第一电极220。电极220可包括导电材料。在各个方面中,钳口构件109a的电极220可由金属制成。钳口构件109a的表面可包括导热部件诸如不锈钢、铜、银、铝、钨、镍,或本领域的技术人员可能想到的任何其他导热材料。涂覆有生物相容性金属涂层的层压复合物可施加到表面。钳口构件109a可包括导热铜和机械强度更强的材料,尤其是更高模量的不锈钢的层压复合物。可通过电沉积的生物相容性金属涂层(诸如铬)保持钳口构件109a的生物相容性,该金属涂层涂覆有不锈钢和铜层压体两者。在一个示例中,电极220可具有围绕刀通道230的U形形状,其中刀可被设置用于往复运动。
如图2所示,不粘涂层235可沉积在电极表面上或以其他方式放置成与电极表面以直接物理方式连通。在一些非限制性示例中,不粘涂层235可包括导电涂层。在其他非限制性示例中,不粘涂层235可包括不导电涂层。虽然图2中未明确示出,但是不粘涂层235可直接沉积在电极220的整个表面上,或者可直接沉积在电极220的表面的一个或多个部分上。不粘涂层235的多个部分可以是连续的或非连续的。在一些另选的方面中,可移除沉积在电极220的表面上的不粘涂层235的部分,从而暴露电极220的表面的该部分。另选地,可在电极220的表面中制造包括一个或多个凹陷特征部,并且不粘涂层235可仅沉积在这些凹陷内。应当理解,可根据任何合适的制造方法将不粘涂层235沉积或以其他方式放置成与电极表面以直接物理方式连通。此类制造方法的非限制性示例可包括图案化印刷或使用包覆模制工艺。
尽管图2描绘了第一钳口构件109a,但应当理解,第二钳口构件109b可类似地涂覆有不粘涂层。第二钳口构件109b可涂覆有与第一钳口构件109a相同的不粘涂层,或者涂覆有不同的不粘涂层。第二钳口构件109b上的不粘涂层可直接沉积在与第二钳口构件109b相关联的电极的整个表面上,或者可直接沉积在与第二钳口构件109b相关联的电极的表面的一个或多个部分上。与第二钳口构件109b相关联的电极的表面上的不粘涂层的多个部分可以是连续的或非连续的。在一些另选的方面中,可移除与第二钳口构件109b相关联的电极上的不粘涂层的部分,从而暴露与第二钳口构件109b相关联的电极的表面的该部分。另选地,可在与第二钳口构件109b相关联的电极的表面中制造包括一个或多个凹陷特征部,并且其上的不粘涂层可仅沉积在这些凹陷内。此外,第一电极220的表面上的不粘涂层的配置可能和与第二钳口构件109b相关联的电极的表面上的不粘涂层相同或不同。
图3至图7以及图10A-D至图12描绘了包括不导电不粘涂层的一个或多个钳口构件的多个方面。
图3描绘了具有导电电极表面的第一钳口构件109a,该导电电极表面通常涂覆有不导电不粘涂层335。不粘涂层335包括通过移除不粘涂层的圆形部分340而产生的图案化涂层345。在一个非限制性示例中,此类圆形部分340可通过工具加工不粘涂层335来移除,诸如在一个非限制性示例中,通过端铣刀加工。移除圆形部分340可导致暴露下面的电极表面的部分。可以注意到,图案化不粘涂层345包括圆形部分340的多个线性阵列,其中中心线性阵列中的圆形部分340的位置偏离任一侧上的线性阵列中的圆形部分340。
应当认识到,图3中所描绘的图案化涂层345仅仅是图案化涂层的一个非限制性示例。因此,图案化涂层可包括单个部分或者可具有从涂层335移除的多个部分。所述多个部分可彼此物理地隔离或者可以是连续的。从不粘涂层335移除的所述一个或多个部分可包括线形、圆形、椭圆形、卵形、矩形、正方形、圆弧矩形或具有由任何闭合的二维形状限定的几何形状的部分。图案化涂层可包括具有相同形状的多个部分340或者可包括具有不同形状的部分。图案化涂层可包括具有相同尺寸的多个部分或者可包括具有不同尺寸的部分。这些部分可以多种方式(包括但不限于规则或不规则间隔的阵列)设置在图案化涂层中。
图3中所描绘的图案化涂层345可通过移除不粘材料的部分来制造,例如通过首先将不粘材料与电极的表面接触,并且然后用制造方法来移除该该材料的该部分以形成图案化涂层。制造图案化不粘涂层345的另选方法可包括,例如将图案化涂层直接印刷在电极的表面上。也可采用用于在电极上产生图案化涂层345的另外的另选方法。
图4描绘了第一钳口构件409,该第一钳口构件具有施加到电极的表面的不导电不粘涂层435。与图3所描绘的不粘涂层335有别,图4中所描绘的不粘涂层435不是图案化涂层。因此,图4中所描绘的不粘涂层435在不粘涂层435的表面中包括多个涂层缺陷(可观察为脱色和销孔),这可被理解为涂层的非预期且不可重复的特征。
图5描绘了具有导电电极表面520的钳口构件509。电极表面520包括多个凹陷特征部542。在图5中,凹陷特征部542包括多个圆形凹陷特征部542。不粘涂层540可被施加到所述多个凹陷特征部542或其中。图案化不粘涂层545可包括施加到所述多个凹陷特征部542或其中的所述多个不粘涂层540。可以注意到,图案化不粘涂层545包括圆形凹陷特征部542的多个线性阵列,其具有施加到凹陷特征部542或其中的不粘涂层540,其中线性阵列倾斜于钳口构件509的纵向轴线。不粘涂层540可完全填充凹陷特征部542,从而形成与导电电极表面520共面的表面。在另选的方面中,不粘涂层540可不完全地填充凹陷特征部542,从而形成从导电电极表面520凹陷的表面。在又一个方面中,不粘涂层540可过度填充凹陷特征部542,从而形成在导电电极表面520上方突出的表面。
应当认识到,图5中所描绘的图案化涂层545仅仅是图案化涂层的一个非限制性示例。因此,图案化涂层可包括施加到单个凹陷特征部或多个凹陷特征部或其中的不粘涂层。这些凹陷特征部可彼此物理地隔离或者可以是连续的。所述一个或多个凹陷特征部可部分延伸穿过电极的厚度。另选的,该一个或多个凹陷特征部可完全延伸穿过电极的厚度,从而允许凹陷特征部从电极的顶侧或底侧接收不粘涂层,例如作为包覆模制工艺的一部分。所述一个或多个凹陷特征部可包括线形、圆形、椭圆形、卵形、矩形、正方形、圆弧矩形或具有由任何闭合的二维形状限定的几何形状的凹陷特征部。图案化涂层可包括设置在具有相同形状的多个凹陷特征部内的不粘涂层或可包括具有不同形状的凹陷特征部。图案化涂层可包括设置在具有相同尺寸的多个凹陷特征部内的不粘涂层,或可包括具有不同尺寸的凹陷特征部。图案化涂层可包括设置在凹陷特征部内的不粘涂层,这些凹陷特征部可以多种方式设置在电极的表面中,包括但不限于规则或不规则间隔的阵列。
图5中所描绘的图案化不粘涂层545可通过从电极表面移除部分以形成凹陷特征部来制造,例如通过使用端铣刀,并且然后用制造方法将不粘材料沉积在凹陷特征部中以形成图案化涂层。制造图案化不粘涂层545的另选方法可包括,例如模塑电极以包括凹陷特征部,然后将不粘材料沉积在其中。也可采用用于在电极上产生图案化涂层545的另外的另选方法。
图6描绘了具有导电电极表面620的钳口构件609。电极表面620包括多个凹陷特征部642。在图6中,凹陷特征部642包括多个细长凹陷特征部642。不粘涂层640可被施加到所述多个凹陷特征部642或其中。图案化不粘涂层646可包括施加到所述多个凹陷特征部642或其中的所述多个不粘涂层640。可以注意到,图案化不粘涂层646包括施加到该多个细长特征部642或其中的不粘涂层640,该多个细长特征部沿着或者平行于钳口构件609的纵向轴线排列。不粘涂层640可完全填充凹陷特征部642,从而形成与导电电极表面620共面的表面。在一个另选的方面中,不粘涂层640可不完全地填充凹陷特征部642,从而形成从导电电极表面620凹陷的表面。在又一个方面中,不粘涂层640可过度填充凹陷特征部642,从而形成在导电电极表面620上方突出的表面。
应当认识到,图6中所描绘的图案化涂层646仅仅是图案化涂层的一个非限制性示例。因此,图案化涂层可包括单个细长凹陷特征部或者可具有多个细长凹陷特征部。这些细长凹陷特征部可彼此物理地隔离或者可以是连续的。该一个或多个凹陷特征部可部分延伸穿过电极的厚度。另选的,该一个或多个凹陷特征部可完全延伸穿过电极的厚度,从而允许凹陷特征部从电极的顶侧或底侧接收不粘涂层,例如作为包覆模制工艺的一部分。更复杂的图案化涂层可衍生自细长凹陷特征部的组合以形成(非限制性示例)鲱骨图案或T形图案,图案化涂层可包括设置在具有相同形状的多个细长凹陷特征部内的不粘涂层或者可包括具有不同形状的细长凹陷特征部。例如,细长特征部可具有相同长度或可具有不同长度。另外,细长特征部可具有相同宽度或者可具有不同宽度。图案化涂层可包括设置在细长凹陷特征部内的不粘涂层,这些细长凹陷特征部可以多种方式设置在电极的表面中,包括但不限于规则或不规则间隔的阵列。
图6中所描绘的图案化涂层646可通过从电极表面移除部分以形成细长凹陷特征部来制造,例如通过使用端铣刀,并且然后用制造方法将不粘材料沉积在细长凹陷特征部中以形成图案化涂层。制造图案化不粘涂层646的另选方法可包括,例如模塑电极以包括细长凹陷特征部,然后将不粘材料沉积在其中。也可采用用于在电极上产生图案化涂层646的另外的另选方法。
图7描绘了具有导电电极表面720的钳口构件的近距离视图。电极表面720包括多个凹陷特征部742。在图7中,凹陷特征部742包括多个细长凹陷特征部742。不粘涂层740可被施加到该多个凹陷特征部742或其中。图案化不粘涂层746可包括施加到所述多个凹陷特征部742或其中的所述多个不粘涂层740。可以注意到,图案化不粘涂层746包括施加到所述多个细长凹陷特征部742或其中的不粘涂层740,该多个细长凹陷特征部沿着或者平行于钳口构件的纵向轴线780排列。不粘涂层740可完全填充凹陷特征部742,从而形成与导电电极表面720共面的表面。在另选的方面中,不粘涂层740可不完全地填充凹陷特征部742,从而形成从导电电极表面720凹陷的表面。在又一个方面中,不粘涂层740可过度填充凹陷特征部742,从而形成在导电电极表面720上方突出的表面。
应当认识到,图7中所描绘的图案化涂层746仅仅是图案化涂层的一个非限制性示例。因此,图案化涂层可包括单个细长凹陷特征部或可具有多个细长凹陷特征部。这些细长凹陷特征部可彼此物理地隔离或者可以是连续的。该一个或多个凹陷特征部可部分延伸穿过电极的厚度。另选的,该一个或多个凹陷特征部可完全延伸穿过电极的厚度,从而允许凹陷特征部从电极的顶侧或底侧接收不粘涂层,例如作为包覆模制工艺的一部分。更复杂的图案化涂层可衍生自细长凹陷特征部的组合以形成(非限制性示例)鲱骨图案或T形图案,图案化涂层可包括设置在具有相同形状的多个细长凹陷特征部内的不粘涂层或者可包括具有不同形状的细长凹陷特征部。例如,细长特征部可具有相同长度或可具有不同长度。另外,细长特征部可具有相同宽度或者可具有不同宽度。图案化涂层可包括设置在细长凹陷特征部内的不粘涂层,这些细长凹陷特征部可以多种方式设置在电极的表面中,包括但不限于规则或不规则间隔的阵列。
图7中所描绘的图案化涂层746可通过从电极表面移除部分以形成细长凹陷特征部来制造,例如通过使用端铣刀,并且然后用制造方法将不粘材料沉积在细长凹陷特征部中以形成图案化涂层。制造图案化不粘涂层746的另选方法可包括,例如模塑电极以包括细长凹陷特征部,然后将不粘材料沉积在其中。也可采用用于在电极上产生图案化涂层746的另外的另选方法。
图8示出了使用具有钳口构件的电外科装置密封的组织的平均总粘附力(lbf)的测量箱形图,该钳口构件包括包含多种图案化不粘涂层的电极。总粘附力是组织粘附力在发生粘附的表面积之上的积分。通过减少粘附面积,可减少总粘附力。在图8中,图案化不粘涂层类似于图7中所描绘的图案化不粘涂层,并且不粘材料可为含氟聚合物。图8中所用的测试组织材料是颈动脉材料的样本。图8比较了由钳口构件密封的组织的总粘附力,其中电极具有包括由不粘材料覆盖的限定量的表面积的表面。包括使用未涂覆涂层的电极的对照结果以进行比较。由不粘材料覆盖的电极的表面积的量表示为由不粘材料覆盖的电极的总表面积的百分比。因此,由不粘材料覆盖的电极的总表面积的百分比可计算为其中At为电极的总表面积,并且Am为由不粘材料覆盖的电极的总表面积的量。
图8中的箱形图显示了由具有45%、68%和76%含氟聚合物表面涂层的电极密封的颈动脉组织的平均粘附力(lbf)。如图8所示,材料对具有由不粘材料覆盖的总表面积的三个百分比值的电极的平均总粘附力分别为约0.232lbf、0.199lbf和0.125lbf。可将这些值与未涂覆涂层的对照电极的值0.342lbf进行比较。箱形图表明,随着由含氟聚合物覆盖的总表面积的百分比增加,组织对电极的平均粘附力降低。尤其值得注意的是,组织对表面的76%涂覆有含氟聚合物的电极的平均粘附力似乎显著小于未涂覆涂层的对照电极。
图9描绘了使用具有如图7所示的不粘材料涂层图案的电极密封的颈动脉样本的平均猝发压力(以mmHg为单位)的箱形图。图9比较了使用总表面积的约76%的百分比由不粘涂层覆盖的电极密封的颈动脉样本的平均猝发压力与使用未涂覆涂层的电极密封的颈动脉样本的平均猝发压力。使用Tukey方法分析图9中的数据,并且在两组样本之间并未发现统计意义上的显著性差异。
图9所描绘的实验结果示出了出人意料的结果,即使当电极的导电部分的接触面积被减少至小于该电极的总表面积的四分之一时,组织基于电外科的血管密封的质量实际上仍不受影响。不受理论的约束,减少的接触面积对RF能量向组织的电传输的影响可能是最小的,因为电流可横向流动穿过涂层中的孔。图16示出了穿过被压缩在第一电极1609a和第二电极1609b之间的组织1690的可能电流流动路径1680。第一电极1609a和第二电极1609b中的每者分别包括不粘材料1635a、b的图案化涂层。已分别将部分1640a、b从不粘材料的图案化涂层1635a、b移除,从而暴露下面的相应电极1609a、b的导电表面。可以认识到,从不粘材料的图案化涂层1635a、b移除的部分1640a、b可提供用于电流流动的小导电路径1680。小导电路径1680可使得足够的电流能够流进组织1690中以通过焦耳加热来升高温度。因此,由具有76%不导电表面涂层的电极密封的组织的密封质量可与由未涂覆涂层的电极密封的组织的密封质量大致相同。
图10A-D描绘了电外科器械的电极部件上的不粘材料的图案化涂层的多个方面。因此,图10A描绘了在包括不粘涂层1035a的电极表面上具有图案化不粘涂层1045a的第一钳口构件1009a,其中已将一个或多个圆形部分1040a从该不粘涂层移除,从而露出其下的电极表面。图10A中所描绘的图案化涂层1045a可通过移除不粘材料的部分来制造,例如通过首先将不粘材料与电极的表面接触,并且然后用制造方法来移除该材料的该部分以形成图案化涂层1045a。制造图案化不粘涂层1045a的另选方法可包括,例如将图案化涂层直接印刷在电极的表面上。也可采用用于在电极上产生图案化不粘涂层1045a的另外的另选方法。
在一些方面中,由图10A中所描绘的图案化不粘涂层1045a覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035a移除的一个或多个圆形部分1040a的数量来调节。在一些另选的方面中,由图10A中所描绘的图案化不粘涂层1045a覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035a移除的一个或多个圆形部分1040a的尺寸来调节。在一些附加的方面中,由图10A中所描绘的图案化不粘涂层1045a覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035a移除的一个或多个圆形部分1040a的形状来调节。应当理解,由图10A中所描绘的图案化不粘涂层1045a覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035a移除的一个或多个圆形部分1040a的数量、尺寸或形状中的一者或多者来调节。
图10B描绘了在包括不粘涂层1035b的电极表面上具有图案化不粘涂层1045b的第一钳口构件1009a,其中已将一个或多个正方形或矩形部分1040b从该不粘涂层移除,从而露出其下的电极表面。图10A中所描绘的图案化涂层1045b可通过移除不粘材料的部分来制造,例如通过首先将不粘材料与电极的表面接触,并且然后用制造方法来移除该材料的该部分以形成图案化涂层1045b。制造图案化不粘涂层1045b的另选方法可包括,例如将图案化涂层直接印刷在电极的表面上。也可采用用于在电极上产生图案化不粘涂层1045b的另外的另选方法。
在一些方面中,由图10B中所描绘的图案化不粘涂层1045b覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035b移除的一个或多个正方形或矩形部分1040b的数量来调节。在一些另选的方面中,由图10B中所描绘的图案化不粘涂层1045b覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035b移除的一个或多个正方形或矩形部分1040b的尺寸来调节。在一些附加的方面中,由图10B中所描绘的图案化不粘涂层1045b覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035b移除的一个或多个正方形或矩形部分1040b的形状来调节。应当理解,由图10A中所描绘的图案化不粘涂层1045b覆盖的电极的总表面积的百分比可通过改变从不粘涂层1035b移除的一个或多个正方形或矩形部分1040b的数量、尺寸或形状中的一者或多者来调节。
图10C和图10D分别描绘了第一钳口构件1009a的表面视图和第二钳口构件1009b的顶视图,其分别在第一电极表面和第二电极表面上具有图案化不粘涂层1045c和图案化不粘涂层1045d。每个图案化不粘涂层1045c和图案化不粘涂层1045d可分别包括不粘涂层1035c和不粘涂层1035d,已分别将一个或多个细长部分1040c和1040d从上述不粘涂层移除,从而露出其下的相应电极表面。图10C和图10D中所描绘的图案化涂层1045c和图案化涂层1045d可通过移除不粘材料的部分来制造,例如通过首先将不粘材料与电极的表面接触,并且然后用制造方法来移除该材料的该部分以形成图案化涂层1045c、d。制造图案化不粘涂层1045c、d的另选方法可包括,例如将图案化涂层直接印刷在电极的表面上。也可采用用于在电极上产生图案化不粘涂层1045c、d的另外的另选方法。
图10C描绘了钳口构件1009a的表面的视图,而图10D描绘了第二钳口构件1009b的顶视图,其中图案化涂层1045d被视为突起部。根据细长部分1040c和1040d的尺寸和形状,将图10C中的第一钳口构件1009a放置成邻近图10D中的第二钳口构件1009b可导致细长部分1040c与细长部分1040d不重叠、部分重叠或完全重叠。在图案化涂层1045c和图案化涂层1045d的一个示例中,其中细长部分1040c与细长部分1040d之间不存在重叠,在第一电极和第二电极之间传输RF电流可能导致电流以横向方式被传输通过压缩在两者间的组织。另选地,如果细长部分1040c与细长部分1040d之间存在至少一些重叠,则在第一电极和第二电极之间传输RF电流可能导致电流以垂直方式被传输通过压缩在两者间的组织。
在一些方面中,分别由图10C和图10D中所描绘的图案化不粘涂层1045c、d覆盖的电极的总表面积的百分比可通过改变从相应不粘涂层1035c、d移除的一个或多个细长部分1040c、d的数量来调节。在一些另选的方面中,分别由图10C和图10D中所描绘的图案化不粘涂层1045c、d覆盖的电极的总表面积的百分比可通过改变从相应不粘涂层1035c、d移除的一个或多个细长部分1040c、d的尺寸(长度和/或宽度)来调节。在一些另选的方面中,分别由图10C和图10D中所描绘的图案化不粘涂层1045c、d覆盖的电极的总表面积的百分比可通过改变从相应不粘涂层1035c、d移除的一个或多个细长部分1040c、d的形状来调节。应当理解,分别由图10C和图10D中所描绘的图案化不粘涂层1045c、d覆盖的电极的总表面积的百分比可通过改变从相应不粘涂层1035c、d移除的一个或多个细长部分1040c、d的数量、尺寸(长度和/或宽度)或形状中的任一者或多者来调节。
图11示出了电极的第一组图案化不粘涂层,其用于测试组织对图案化涂覆电极的粘附力的量以及对组织(例如颈动脉)上的密封进行猝发压力测试。图11中所描绘的图案化涂层类似于图10A中所描绘的那些图案化涂层。图案化涂层由不导电材料(聚四氟乙烯的形式)的不粘涂层1135制成,其中已将圆形部分1140从该不粘涂层移除。测试电极包括四(4)个校正区。在具有第一图案1160的校正区1中,未将任何材料从不粘涂层1135移除。在具有第二图案1162的区2、具有第三图案1164的区3以及具有第四图案1166的区4中,已将不同量的材料从不粘涂层1135移除。第二图案1162、第三图案1164和第四图案1166分别通过移除各种数量的圆形部分1140来制造。应当指出的是,从区2-4中的不粘涂层1135移除的圆形部分1140均具有相同的尺寸和形状。因此,由图案化不粘涂层1162、1164和1166覆盖的电极的总表面积的百分比仅取决于从相应校正区中的不粘涂层1135移除的圆形部分1140的相对数量。
虽然未示出,但是电极的第二组图案化不粘涂层用于测试组织对图案化涂覆电极的粘附力的量以及对组织(例如颈动脉)上的密封进行猝发压力测试。第二组图案化不粘涂层基于图10B中所描绘的图案化涂层。图案化涂层由不导电材料(聚四氟乙烯的形式)的不粘涂层制成,其中已将正方形部分从该不粘涂层移除。具有图10B中所描绘的图案化涂层的测试电极包括四(4)个校正区。在具有第一图案的校正区1中,未将任何材料从不粘涂层移除。在区2、区3和区4中,已将不同量的材料从不粘涂层移除。第二图案、第三图案和第四图案分别通过移除各种数量的正方形部分来制造。应当指出的是,从区2-4中的不粘涂层移除的正方形部分均具有相同的尺寸和形状。因此,由图案化不粘涂层覆盖的电极的总表面积的百分比仅取决于从相应校正区中的不粘涂层移除的正方形部分的相对数量。
图12示出了电极的第三组图案化不粘涂层,其用于测试组织对图案化涂覆电极的粘附力的量以及对组织(例如颈动脉)上的密封进行猝发压力测试。图12中所描绘的图案化涂层类似于图10C和图10D中所描绘的那些图案化涂层。测试电极包括顶部测试电极1209a、1219a和底部测试电极1209b、1219b。测试电极可与分别形成电外科装置的第一钳口构件和第二钳口构件的部件的电极相关。顶部电极1209a、1219a上的图案化涂层由不导电材料(聚四氟乙烯的形式)的不粘涂层1235a制成。底部电极1209b、1219b上的图案化涂层由不导电材料(聚四氟乙烯的形式)的不粘涂层1235b制成。尽管出于本文所公开的测试的目的,测试电极1290a、b和1219a、b涂覆有相同的不导电材料,但可以认识到,此类组合物不是限制性的。因此,第一电极和第二电极的图案化不粘涂层可包含相同的材料或可包含不同的材料。作为测试规程的一部分,顶部测试电极1209a、1219a和底部测试电极1209b、1219b被制造成具有两种不同厚度的不粘涂层1235a、b。一组测试电极被制造成具有约0.020英寸厚度的不粘涂层1235a、b。第二组测试电极被制造成具有约0.032英寸厚度的不粘涂层1235a、b。
顶部电极1209a、1219a和底部电极1209b、1219b上的图案化不粘涂层由相应的不粘涂层1235a、b制成,其中已将细长部分1240a-c和1242a-c从该相应的不粘涂层1235a、b移除。测试电极包括四(4)个校正区。在具有第一图案1260的校正区1中,未将任何材料从不粘涂层1235a、b移除。在具有第二图案1262的区2、具有第三图案1264的区3以及具有第四图案1266的区4中,已将不同量的材料从顶部电极1209a、1219a和底部电极1209b、1219b中的每者的不粘涂层1235a、b移除,从而暴露下面的相应电极的表面。
从第二图案1262移除的细长部分1240a、1242a、从第三图案1264移除的细长部分1240b、1242b,以及从第四图案1266移除的细长部分1240c、1242c均具有大致相同的长度,但其各自的宽度不同。因此,由图案化不粘涂层1262、1264和1266覆盖的电极的总表面积的百分比仅取决于从相应校正区中的不粘涂层1235a、b移除的相应细长部分的相对宽度。从图12可以认识到,当顶部电极1209a、1219a处于相应的底部电极1209b、1219b的近侧位置时,相应的顶部细长部分的部分可与相应的底部细长部分形成一定量的重叠,其取决于顶部细长部分和底部细长部分的相对宽度。例如,在区2中,细长部分1240a和1242a的相应宽度足够窄,使得细长部分不发生重叠。因此,对于图案化不粘涂层1262,从顶部电极1219a传到底部电极1219b的电流将仅以横向方式穿过压缩在两者间的任何组织。在区3中,细长部分1240b和1242b的相应宽度不允许细长部分重叠,但相应的细长部分的边缘可几乎对齐。因此,对于图案化不粘涂层1264,从顶部电极1219a传到底部电极1219b的电流可在相应细长部分的边缘之间以倾斜方式通过压缩在两者间的任何组织。在区4中,细长部分1240c和1242c的相应宽度足够宽,使得细长部分可发生一些量的重叠。因此,对于图案化不粘涂层1266,从顶部电极1209a传到底部电极1209b的电流将仅以垂直方式穿过压缩在两者间的任何组织。
使用具有如上文所公开的并且如图10A-D、图11和图12所描绘的图案化不粘涂层的电极在颈动脉的样本上进行测试。设计这些测试以确定使用具有不同几何形状和由不粘材料覆盖的总表面积的百分比的电极密封的组织对组织粘附力和基于电外科的血管密封的质量的影响。表2公开了由不粘材料覆盖的总表面积的百分比的量,用于上文所公开的不粘涂层图案中的每者的校正区。应当理解,较高值的校正区编号对应于从表面移除具有较大部分不粘涂层的电极(从涂层移除更大量的圆形或正方形部分,或以细长部分的较大宽度)。
表2
由不粘材料覆盖的总表面积的百分比
图13至图15中所示的图表按校正区编号参考此表。
图13示出了样本颈动脉对如图10A-D至图12中所示以及如上文所公开的样本电极的粘附力(lbf)的量的箱形图。电极参考自图案化不粘涂层(校正区1-4)和图案化几何形状的类型。“校正区”值对应于由如上表2所公开的不粘材料覆盖的总表面积的百分比。“控制”电极是在整个电极表面上具有导电硅涂层的电极。“孔”图案参考图10A和图11中所描绘的图案。“华夫”图案参考图10B中所描绘的图案,其设置在与图11中所描绘的孔图案的校正区几何形状等同的校正区几何形状中。“偏移”图案参考图10C和图10D和图12中所描绘的图案。呈现两种型式的“偏移”图案,其中一种为不粘材料的厚度为约0.02英寸厚,并且另一种为不粘材料的厚度为约0.032英寸厚。可以注意到,在0.032"厚的偏移电极的两个区(区2和区4)上测试的血管是两天的,与在其他区上测试为一天的血管相对。可以观察到,使用控制电极密封的组织的粘附力分布广泛,而使用图案化不粘涂层密封的样本的粘附力一般分布更狭窄。此类结果表明,图案化涂层导致组织对电极表面的粘附力更具重复性。
图14示出了样本颈动脉被如图10A-D至图12中所示以及如上文所公开的样本电极中的每者施加了基于电外科的血管密封后的猝发压力(以mmHg为单位)的箱形图。电极参考自图案化不粘涂层(校正区1-4)和图案化几何形状的类型。“校正区”值对应于由如上表2所公开的不粘材料覆盖的总表面积的百分比。“控制”电极是在整个电极表面上具有导电硅涂层的电极。“孔”图案参考图10A和图11中所描绘的图案。“华夫”图案参考图10B中所描绘的图案,其设置在与图11中所描绘的孔图案的校正区几何形状等同的校正区几何形状中。“偏移”图案参考图10C和图10D和图12中所描绘的图案。呈现两种型式的“偏移”图案,其中一种为不粘材料的厚度为约0.02英寸厚,并且另一种为不粘材料的厚度为约0.032英寸厚。可以注意到,在0.032"厚的偏移电极的两个区(区2和区4)上测试的血管是两天的,与在其他区上测试为一天的血管相对。
可以认识到,包括不导电材料的最佳图案化不粘材料涂层可以是使组织对电极的粘附力最小化并且使由电极产生的密封的猝发压力最大化的图案化不粘材料涂层。图15描绘了颈动脉样本对电极的粘附力的主效应曲线图。主效应曲线图按电极类型将图13中所描绘的结果聚集在曲线图的左手部分中,并且通过校正区(即,通过不粘材料所覆盖的总表面积的百分比)将图13中所描绘的结果聚集在曲线图的右手部分中。可以观察到,使用具有任何不粘材料涂层图案的电极密封的组织样本对电极具有比对照物更低的平均粘附力值。此外,无论所使用的图案如何,观察到组织对电极的平均粘附力的变化很小。
图3至图7和图10A-D至图12以及上文所公开的它们的描述呈现了包括多个不粘涂层图案的钳口构件的多个方面。虽然本文已公开了此类涂层图案的多个方面,但是此类方面不应理解为限制性的。因此,涂层图案可包括可被构造在一个或多个钳口构件或电极的表面上的任何合适的涂层图案。涂层图案通常可包括施加到电极的平坦表面的涂层图案、垂直于电极表面上方延伸的一个或多个凸起或升高特征部,或垂直于电极表面下方延伸的一个或多个凹陷特征部。应当理解,术语“设置在电极上的不粘材料”涵盖将材料施加到电极的平坦表面上、垂直于电极表面上方延伸的一个或多个凸起或升高特征部,或垂直于电极表面下方延伸的一个或多个凹陷特征部。本文不对制造涂层图案的方法施加任何明示或暗示的限制。
涂层图案可包括单个特征部或多个特征部。单个特征部或多个特征部的范围可能有限,诸如设置在电极上的不粘材料的小圆形部分(例如,图5)或从涂覆电极的不粘材料移除的小圆形部分(例如,图3)。单个特征部或多个特征部可具有更大的延伸范围,诸如设置在电极上的不粘材料的细长部分(例如,图6和图7)或从涂覆电极的不粘材料移除的细长部分(例如,图10C、图10D)。单个特征部或多个特征部—具有有限范围或扩展范围—不限于其各自的形状、尺寸或在电极表面上的尺寸。单个特征部或多个特征部—具有有限范围或扩展范围—不限于它们各自关于电极表面的配置。因此,例如,不粘材料的细长部分可沿与电极的纵向轴线基本上平行的轴线延伸。另选地,不粘材料的细长部分可沿与电极的纵向轴线基本上垂直的轴线延伸。在又一另选示例中,不粘材料的细长部分可沿与第一电极的纵向轴线既不基本上平行也不基本上垂直的轴线延伸。
涂层图案可包括多个特征部,所述多个特征部可包括任何组合或设置在电极表面上的不粘材料的部分或从设置在电极表面上的不粘材料的涂层移除的部分的任何组合。可以组合多个特征部。此外,多个特征部可关于电极的表面对称地设置,或者它们可关于电极的表面不对称地设置。多个特征部—具有有限范围或扩展范围—不限于它们关于电极相对于彼此的表面的配置。
电外科装置诸如图1A、图1B中所描绘的电外科装置可包括多个钳口,每个钳口均具有电极。可将图案化不粘涂层施加到所述多个电极中的任一者或多者。施加到所述多个电极中的任一者的图案化不粘涂层可包括与施加到所述多个电极中的任何其他电极的图案化不粘涂层相同的不粘材料。另选地,施加到所述多个电极中的任一者的图案化不粘涂层可包括与包括施加到所述多个电极中的任何其他电极的图案化不粘涂层的不粘材料不同的不粘材料。施加到所述多个电极中的任一者的不粘涂层图案可包括与施加到该多个电极中的任何其他电极的不粘涂层图案相同的不粘涂层图案。另选地,施加到该多个电极中的任一者的不粘涂层图案可包括与施加到该多个电极中的任何其他电极的不粘涂层图案不同的不粘材料图案。
虽然已经通过描述若干方面示出了本文的各个方面,并且虽然已经相当详细地描述了示例性实施方案,但是申请人的意图不在于将所附权利要求的范围约束或以任何方式限制到这些细节中。本领域的技术人员可容易看出另外的优点和修改形式。例如,普遍认为,内窥镜式手术比腹腔镜式手术更常见。因此,本发明对内窥镜式手术和设备进行了讨论。然而,本文使用的诸如“内窥镜式”的术语不应被理解为将本发明限于仅结合内窥镜式管(例如,套管针)使用的器械。与此相反,本发明据认为可用于进入受限于小切口的任何手术中,包括(但不限于)腹腔镜式手术以及开腹手术。
此外,尽管已举例说明和描述了多个形式,但是申请人的意图并非将所附权利要求的范围约束或限制在此类细节中。在不脱离本公开的范围的情况下,可实现对这些形式的许多修改、变化、改变、替换、组合和等同物,并且本领域技术人员将想到这些形式的许多修改、变化、改变、替换、组合和等同物。此外,另选地,可将与所描述的形式相关联的每个元件的结构描述为用于提供由所述元件执行的功能的器件。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权利要求旨在涵盖属于本发明所公开的形式范围内的所有此类修改形式、组合和变型形式。所附权利要求旨在涵盖所有此类修改、变化、改变、替换、修改和等同物。
为了公开的简洁和清楚,已经以框图形式而不是详细地示出了前述公开的所选方面。本文所提供的详细描述的一些部分可根据对存储在一个或多个计算机存储器或一个或多个数据存储装置(例如软盘、硬盘驱动器、光盘(CD)、数字视频磁盘(DVD)或数字磁带)中的数据进行操作的指令来呈现。本领域的技术人员用此类描述和表达向本领域的其它技术人员描述和传达他们的工作要旨。通常,算法是指导致所需结果的有条理的步骤序列,其中“步骤”是指物理量和/或逻辑状态的操纵,物理量和/或逻辑状态可以(但不一定)采用能被存储、转移、组合、比较和以其他方式操纵的电或磁信号的形式。常用于指这些信号,如位、值、元素、符号、字符、术语、数字等。这些和类似的术语可与适当的物理量相关联并且仅仅是应用于这些量和/或状态的方便的标签。
除非上述公开中另外明确指明,否则可以理解的是,在上述公开中,使用术语诸如“处理”或“估算”或“计算”或“确定”或“显示”的讨论是指计算机系统或类似的电子计算装置的动作和进程,其操纵表示为计算机系统的寄存器和存储器内的物理(电子)量的数据并将其转换成相似地表示为计算机系统存储器或寄存器或其他此类信息存储、传输或显示设备内的物理量的其他数据。
在一般意义上,本领域的技术人员将会认识到,可以用多种硬件、软件、固件或其任何组合单独和/或共同实施的本文所述的各个方面可以被看作是由多种类型的“电子电路”组成。因此,如本文所用,“电子电路”包括但不限于具有至少一个离散电路的电子电路、具有至少一个集成电路的电子电路、具有至少一个专用集成电路的电子电路、形成由计算机程序配置的通用计算装置的电子电路(如,至少部分地实施本文所述的方法和/或装置的由计算机程序配置的通用计算机,或至少部分地实施本文所述的方法和/或装置的由计算机程序配置的微处理器)、形成存储器装置(如,形成随机存取存储器)的电子电路,和/或形成通信装置(如,调制解调器、通信开关或光电设备)的电子电路。本领域的技术人员将会认识到,可以模拟或数字方式或它们的一些组合实施本文所述的主题。
上述具体实施方式已通过使用框图、流程图和/或示例阐述了装置和/或过程的各种形式。只要此类框图、流程图和/或示例包含一个或多个功能和/或操作,本领域的技术人员就要将其理解为此类框图、流程图和/或示例中的每个功能和/或操作都可以单独和/或共同地通过多种硬件、软件、固件或实际上它们的任何组合来实施。在一种形式中,本文所述的主题的若干部分可以通过专用集成电路(ASIC)、现场可编程门阵列(FPGA)、数字信号处理器(DSP)或其他集成格式来实施。然而,本领域的技术人员将会认识到,本文所公开的形式的一些方面可以作为在一台或多台计算机上运行的一个或多个计算机程序(如,作为在一个或多个计算机系统上运行的一个或多个程序),作为在一个或多个处理器上运行的一个或多个程序(如,作为在一个或多个微处理器上运行的一个或多个程序),作为固件,或作为实际上它们的任何组合全部或部分地在集成电路中等效地实现,并且根据本发明,设计电子电路和/或编写软件和/或硬件的代码将在本领域技术人员的技术范围内。另外,本领域的技术人员将会认识到,本文所述主题的机制能够作为多种形式的一个或多个程序产品进行分布,并且本文所述主题的示例性形式适用,而不管用于实际进行分布的信号承载介质的具体类型是什么。信号承载介质的示例包括但不限于如下:可录式媒体,诸如软盘、硬盘驱动器、光盘(CD)、数字视频光盘(DVD)、数字磁带、计算机存储器等;和传输式介质,诸如数字和/或模拟通信介质(例如,光纤缆线、波导、有线通信链路、无线通信链路(例如,发射器、接收器、传输逻辑、接收逻辑等)等)。
在一些情况下,一个或多个元件可使用表达“耦接”和“连接”连同其衍生词来描述。应当理解,并不希望这些术语彼此同义。例如,某些方面可使用术语“连接”来描述,以表示两个或更多个元件彼此以直接物理方式接触或电接触。在另一个示例中,一些方面可使用术语“联接”来描述,以表示两个或更多个元件以直接物理方式接触或电接触。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。应当理解,包含在不同的其他部件内或与不同的其他部件连接的不同部件的所描绘的架构仅仅是示例,并且实际上可实现许多其他架构以实现相同的功能。在概念意义上,获得相同功能性的组件的任何布置结构方式都是有效“相关联的”,从而获得所需的功能性。因此,本文中为获得特定功能性而结合在一起的任何两个组件都可被视为彼此“相关联”,从而获得所需的功能性,而不论结构或中间组件如何。同样,如此相关联的任何两个部件也可视为彼此“操作地连接”或“操作地联接”,以实现所需的功能性,并且能够如此相关联的任何两个部件都可视为彼此“可操作地联接”,以实现所需的功能性。可操作耦接的具体示例包括但不限于物理上可匹配和/或物理上相互作用的部件,和/或可无线交互的,和/或无线相互作用的部件,和/或逻辑上相互作用的,和/或可在逻辑上相互作用的部件,和/或电气相互作用的部件,和/或可电气相互作用的部件,和/或光学相互作用的部件,和/或可光学相互作用的部件。
在其他情况下,一个或多个部件在本文中可被称为“被构造成能够”、“可被构造成能够”、“可操作/可操作地”、“适于/可适于”、“能够”、“可适形/适形于”等。本领域的技术人员将会认识到,除非上下文另有所指,否则“被构造成能够”通常可涵盖活动状态的部件和/或未活动状态的部件和/或待机状态的部件。
虽然已经示出并描述了本公开的特定方面,但是对本领域的技术人员将显而易见的是,基于本文的教导,可在不脱离本文所述的主题的情况下和其更广泛的方面作出改变和变型,并且因此如在本文所述的主题的真实范围内,并所附权利要求将所有此类改变和变型包括在其范围内。本领域的技术人员应当理解,一般而言,本文、以及特别是所附权利要求(例如,所附权利要求的正文)中所使用的术语通常旨在为“开放”术语(例如,术语“包括”应解释为“包括但不限于”,术语“具有”应解释为“至少具有”,术语“包含”应解释为“包含但不限于”等)。本领域的技术人员还应当理解,如果所引入权利要求叙述的具体数目为预期的,则这样的意图将在权利要求中明确叙述,并且在不存在这样的叙述的情况下,不存在这样的意图。例如,为有助于理解,下述所附权利要求可含有对介绍性短语“至少一个”和“一个或多个”的使用以引入权利要求。然而,对此类短语的使用不应视为暗示通过不定冠词“一个”或“一种”引入权利要求表述将含有此类引入权利要求表述的任何特定权利要求限制在含有仅一个这样的表述的权利要求中,甚至当同一权利要求包括介绍性短语“一个或多个”或“至少一个”和诸如“一个”或“一种”(例如,“一个”和/或“一种”通常应解释为意指“至少一个”或“一个或多个”)的不定冠词时;这也适用于对用于引入权利要求表述的定冠词的使用。
另外,即使明确叙述引入权利要求叙述的特定数目,本领域的技术人员应当认识到,此种叙述通常应解释为意指至少所叙述的数目(例如,在没有其他修饰语的情况下,对“两个叙述”的裸叙述通常意指至少两个叙述、或两个或更多个叙述)。此外,在其中使用类似于“A、B和C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B和C中的至少一者的系统”将包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。在其中使用类似于“A、B或C中的至少一者等”的惯例的那些情况下,一般而言,这种结构意在具有本领域的技术人员将理解所述惯例的意义(例如,“具有A、B或C中的至少一者的系统”应当包括但不限于具有仅A、仅B、仅C、A和B一起、A和C一起、B和C一起和/或A、B和C一起等的系统)。本领域的技术人员还应当理解,通常,除非上下文另有指示,否则无论在具体实施方式、权利要求或附图中呈现两个或更多个替代术语的转折性词语和/或短语应理解为涵盖包括所述术语中的一者、所述术语中的任一个或这两个术语的可能性。例如,短语“A或B”通常将被理解为包括“A”或“B”或“A和B”的可能性。
对于所附权利要求,本领域的技术人员将会理解,其中表述的操作通常可以任何顺序进行。另外,尽管以一定顺序列出了多个操作流程,但应当理解,可以不同于所示顺序的其它顺序进行所述多个操作,或者可以同时进行所述多个操作。除非上下文另有规定,否则此类替代排序的示例可包括重叠、交错、中断、重新排序、增量、预备、补充、同时、反向,或其它改变的排序。此外,除非上下文另有规定,否则像“响应于”、“相关”这样的术语或其它过去式的形容词通常不旨在排除此类变体。
值得一提的是,任何对“一个方面(one aspect)”、“一方面(an aspect)”、“一种形式(one form)”、“一形式(a form)”的提及均意指结合所述方面所述的具体特征、结构或特性包括在至少一个方面中。因此,出现在整篇说明书中的不同位置中的短语“在一个方面”、“在一方面”、“在一种形式中”或“在一形式中”不一定都是指同一方面。此外,具体特征、结构或特性可在一个或多个方面中以任何合适的方式组合。
对于本文中使用的基本上任何复数和/或单数术语,本领域技术人员可从复数转换成单数和/或从单数转换成复数,只要适合于上下文和/或应用即可。为清楚起见,各种单数/复数置换在本文中没有明确表述。
在某些情况下,对系统或方法的使用可发生在一个地区中,即使部件位于所述地区外部。例如,在分布式计算上下文中,对分布式计算系统的使用可发生在一个地区中,即使所述系统的部件可能位于所述地区外部(例如,位于所述地区外部的继电器、服务器、处理器、信号承载介质、传输计算机、接收计算机等)。
系统或方法的销售同样可发生在一个地区中,即使所述系统或方法的部件位于和/或用于所述地区外部。此外,在一个地区中实施用于执行方法的系统的至少一部分不排除在另一个地区中使用所述系统。
上述美国专利、美国专利申请公开、美国专利申请、国外专利、国外专利申请、本说明书中所提及和/或任何应用数据表中所列出的非专利申请或任何其他公开材料均在不与其相矛盾的情况下以引用方式并入本文。因此,并且在必要的程度下,本文明确列出的公开内容代替以引用方式并入本文的任何冲突材料。据称以引用方式并入本文但与本文列出的现有定义、陈述或其它公开材料相冲突的任何材料或其部分,将仅在所并入的材料与现有的公开材料之间不产生冲突的程度下并入。
总而言之,已描述了由采用本文所述的概念产生的许多有益效果。为了举例说明和描述的目的,已经提供了一个或多个形式的上述具体实施方式。这些具体实施方式并非意图为详尽的或限定到本发明所公开的精确形式。可以按照上述教导内容对本发明进行修改或变型。选择和描述的一个或多个形式是为了说明原理和实际应用,从而使本领域的普通技术人员能够利用适用于预期的特定用途的所述多个形式和多种修改形式。与此一同提交的权利要求书旨在限定完整范围。
本文所述主题的各个方面在以下编号的实施例中描述:
实施例1.一种电外科系统,该电外科系统包括:
RF电流发生器;柄部主体;和
端部执行器,该端部执行器与柄部主体以机械方式连通,该端部执行器包括:
第一钳口,该第一钳口包括与RF电流发生器的第一端子电连通的第一能量递送表面;和
第二钳口,该第二钳口包括与RF电流发生器的第二端子电连通的第二能量递送表面,
其中,所述第一能量递送表面的至少一部分包括不导电不粘材料的图案化涂层。
实施例2.根据实施例1所述的电外科系统,其中第一能量递送表面具有第一区域,并且包括图案化涂层的第一能量递送表面的至少一部分具有第二区域。
实施例3.根据实施例2所述的电外科系统,其中第二区域与第一区域的比率小于或等于约0.9。
实施例4.根据实施例2所述的电外科系统,其中第二区域与第一区域的比率小于或等于约0.7。
实施例5.根据实施例2所述的电外科系统,其中第二区域与第一区域的比率小于或等于约0.5。
实施例6.根据实施例1至实施例5中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于1100mJ/m2和5mJ/m2之间的表面能值。
实施例7.根据实施例1至实施例5中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于50mJ/m2和40mJ/m2之间的表面能值。
实施例8.根据实施例1至实施例5中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于40mJ/m2和12mJ/m2之间的表面能值。
实施例9.一种用于电外科装置的端部执行器,该端部执行器包括:
第一钳口,该第一钳口包括被构造成能够与RF电流发生器的第一端子电连通的第一能量递送表面;和
第二钳口,该第二钳口包括被构造成能够与RF电流发生器的第二端子电连通的第二能量递送表面,
其中,所述第一能量递送表面的至少一部分包括不导电不粘材料的图案化涂层。
实施例10.根据实施例9所述的端部执行器,其中第一能量递送表面具有第一区域,并且包括图案化涂层的第一能量递送表面的至少一部分具有第二区域。
实施例11.根据实施例10所述的端部执行器,其中第二区域与第一区域的比率小于或等于约0.8。
实施例12.根据实施例10所述的端部执行器,其中第二区域与第一区域的比率小于或等于约0.7。
实施例13.根据实施例10所述的端部执行器,其中第二区域与第一区域的比率小于或等于约0.5。
实施例14.根据实施例9至实施例13中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于1100mJ/m2和5mJ/m2之间的表面能值。
实施例15.根据实施例9至实施例13中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于50mJ/m2和40mJ/m2之间的表面能值。
实施例16.根据实施例9至实施例13中任一项或多项所述的电外科系统,其中不导电不粘材料具有介于40mJ/m2和12mJ/m2之间的表面能值。
实施例17.根据实施例9至实施例16中任一项或多项所述的端部执行器,其中图案化涂层包括设置在第一能量递送表面中制造的一个或多个凹陷特征部内的不导电不粘材料。
实施例18.根据实施例9至实施例17中任一项或多项所述的端部执行器,其中,所述一个或多个凹陷特征部包括一个或多个圆形特征部。
实施例19.根据实施例9至实施例18中任一项或多项所述的端部执行器,其中,所述一个或多个凹陷特征部包括一个或多个矩形特征部。
实施例20.根据实施例9至实施例19中任一项或多项所述的端部执行器,其中,所述一个或多个凹陷特征部包括一个或多个线形特征部。
实施例21.根据实施例20所述的端部执行器,其中,所述一个或多个线形特征部沿着或平行于第一能量递送表面的纵向轴线设置。
实施例22.根据实施例20所述的端部执行器,其中,所述一个或多个线形特征部沿着或平行于第一能量递送表面的横向轴线设置。
实施例23.根据实施例9至实施例22中任一项或多项所述的端部执行器,其中图案化涂层包括设置在第一能量递送表面的暴露表面上并与第一能量递送表面的暴露表面以直接物理方式连通的不导电不粘材料。
实施例24.根据实施例23所述的端部执行器,其中图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个部分。
实施例25.根据实施例24所述的端部执行器,其中不粘材料的部分包括不粘材料的一个或多个圆形部分。
实施例26.根据实施例24至实施例25中任一项或多项所述的端部执行器,其中不粘材料的部分包括不粘材料的一个或多个矩形部分。
实施例27.根据实施例24至实施例26中任一项或多项所述的端部执行器,其中不粘材料的部分包括不粘材料的一个或多个细长部分。
实施例28.根据实施例21至实施例27中任一项或多项所述的端部执行器,其中第二能量递送表面的至少一部分包括设置在第二能量递送表面的暴露表面上并与第二能量递送表面的暴露表面以直接物理方式连通的不导电不粘材料的第二图案化涂层;并且
其中当将第一钳口引入到邻近第二钳口的位置时,图案化涂层相对于第二图案化涂层在空间上偏移。
实施例29.根据实施例28所述的端部执行器,其中第二能量递送表面具有第三区域,并且包括第二图案化涂层的第二能量递送表面的至少一部分具有第四区域。
实施例30.根据实施例29所述的端部执行器,其中第四区域与第三区域的比率小于或等于约0.8。
实施例31.根据实施例29所述的端部执行器,其中第四区域与第三区域的比率小于或等于约0.7。
实施例32.根据实施例29所述的端部执行器,其中第四区域与第三区域的比率小于或等于约0.6。
实施例33.根据实施例28至实施例32中任一项或多项所述的端部执行器,其中图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个细长部分,并且第二图案化涂层包括不粘材料的涂层,该不粘材料的该涂层不含该不粘材料的一个或多个第二细长部分。
Claims (5)
1.一种电外科系统,所述电外科系统包括:
RF电流发生器;
柄部主体;和
端部执行器,所述端部执行器与所述柄部主体以机械方式连通,所述端部执行器包括:
第一钳口,所述第一钳口包括与所述RF电流发生器的第一端子电连通的具有第一表面积的第一能量递送表面;和
第二钳口,所述第二钳口包括与所述RF电流发生器的第二端子电连通的具有第二表面积的第二能量递送表面,
其中,所述第一能量递送表面的第一纵向部分包括不导电不粘材料的涂层,
其中,所述第一能量递送表面的第二纵向部分包括具有第一未涂覆区域的第一能量递送表面的未涂覆部分,
其中,所述第二能量递送表面的第一纵向部分包括不导电不粘材料的涂层,
其中,所述第二能量递送表面的第二纵向部分包括具有第二未涂覆区域的第二能量递送表面的未涂覆部分,
其中,在所述第一钳口与所述第二钳口并置的配置中,所述第二能量递送表面的所述第二纵向部分的第一纵向区段与所述第一能量递送表面的所述第一纵向部分的第一纵向区段直接相对设置,
其中,在所述第一钳口与所述第二钳口并置的配置中,所述第二能量递送表面的所述第二纵向部分的第二纵向区段与所述第一能量递送表面的所述第二纵向部分的第一纵向区段直接相对设置,
其中,在所述第一钳口与所述第二钳口并置的构造中,所述第二能量递送表面的所述第一纵向部分的第一纵向区段与所述第一能量递送表面的所述第二纵向部分的第二纵向区段直接相对设置,和
其中,在所述第一钳口与所述第二钳口并置的构造中,所述第二能量递送表面的所述第一纵向部分的第二纵向区段与所述第一能量递送表面的所述第一纵向部分的第二纵向区段直接相对设置。
2.根据权利要求1所述的电外科系统,其中,所述不导电不粘材料具有介于1100mJ/m2和5mJ/m2之间的表面能值。
3.根据权利要求1所述的电外科系统,其中,所述不导电不粘材料具有介于50mJ/m2和40mJ/m2之间的表面能值。
4.根据权利要求1所述的电外科系统,其中,所述不导电不粘材料具有介于40mJ/m2和12mJ/m2之间的表面能值。
5.一种用于电外科装置的端部执行器,所述端部执行器包括:
第一钳口,所述第一钳口包括被构造成能够与RF电流发生器的第一端子电连通的具有第一表面积的第一能量递送表面;和
第二钳口,所述第二钳口包括被构造成能够与所述RF电流发生器的第二端子电连通的具有第二表面积的第二能量递送表面,
其中,所述第一能量递送表面的第一纵向部分包括不导电不粘材料的涂层,
其中,所述第一能量递送表面的第二纵向部分包括具有第一未涂覆区域的第一能量递送表面的未涂覆部分,
其中,所述第二能量递送表面的第一纵向部分包括不导电不粘材料的涂层,
其中,所述第二能量递送表面的第二纵向部分包括具有第二未涂覆区域的第二能量递送表面的未涂覆部分,
其中,在所述第一钳口与所述第二钳口并置的配置中,所述第二能量递送表面的所述第二纵向部分的第一纵向区段与所述第一能量递送表面的所述第一纵向部分的第一纵向区段直接相对设置,
其中,在所述第一钳口与所述第二钳口并置的配置中,所述第二能量递送表面的所述第二纵向部分的第二纵向区段与所述第一能量递送表面的所述第二纵向部分的第一纵向区段直接相对设置,
其中,在所述第一钳口与所述第二钳口并置的构造中,所述第二能量递送表面的所述第一纵向部分的第一纵向区段与所述第一能量递送表面的所述第二纵向部分的第二纵向区段直接相对设置,和
其中,在所述第一钳口与所述第二钳口并置的构造中,所述第二能量递送表面的所述第一纵向部分的第二纵向区段与所述第一能量递送表面的所述第一纵向部分的第二纵向区段直接相对设置。
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US11497546B2 (en) | 2022-11-15 |
EP3600104A1 (en) | 2020-02-05 |
CN110719758A (zh) | 2020-01-21 |
WO2018183230A1 (en) | 2018-10-04 |
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