CN101147695B - 用于电外科器械的端部执行器涂层 - Google Patents
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Abstract
用于电外科器械的端部执行器涂层，该端部执行器能够将双极RF能量施加到组织中。端部执行器具有第一和第二电极，与组织形成RF接触电路。至少一个电极上具有电介质涂层，与组织形成RF电路。电介质涂层覆盖电极之一以与组织形成电容耦合电路，或者可具有延伸穿过电介质涂层的至少一个打开的通道，以使组织与电极接触，RF能量能够穿过。电极上的电介质涂层可被掩蔽，以穿过电介质形成通道，或者可用各种技术部分移除电介质涂层以形成通道。电介质涂层可提供屏障以防止涂覆有电介质涂层的电极和嵌置在组织中的导电紧固件之间短路。或者，钉仓涂层可用来减少在将RF能量施加到组织上期间产生的在钉仓热塑料上的表面层电荷。
Description
技术领域
本发明整体上涉及电外科器械，更具体而言，涉及用于电外科器械的涂层，所述电外科器械使用生热能量来结合缝钉进行烧灼、凝固和组织连接/接合，以在组织中形成止血缝合/凝固/切割线。
背景技术
外科手术通常需要切割组织，这可在操作部位或者手术部位引起流血。止血，或者称阻止流血，对外科医生减少失血和减少手术并发症至关重要。医生可采用各种止血控制技术，例如缝合、钉合、施加外科钳口具、施加超声能量、施加激光能量以及施加单极或双极电能。医生通常在手术中采用这些手段的组合来进行止血。对于开放手术，易于通过较大切口进入手术部位，并且易于施加装置或者施用技术来减少流血。通过插入于较小切口的较小进入端口，来进行内窥镜手术。由于外科医生没有大的切口来进行工作、难以观察手术部位、以及对手术部位的接近受限于小的进入端口或套管针的数量，因此内窥镜手术更具挑战。在手术中接近患者手术部位通常采用电烙器械。这些器械施加单极或双极射频(RF)能量来烧灼组织切口中的局部“出血部位”。单极器械具有一个与切割或烧灼器械相联的电极，并且返回或接地电极连接到患者的较远部分。通过将能量从装置的尖端输送到患者出血部位，从而对出血部位施加能量。
双极器械通常对器械的可动的对置钳口构件上的一对电极施加烧灼电流。通过将打开的钳口构件夹紧在组织上使电极和组织接触，然后将RF双极电能施加到在钳口构件中被压缩的组织上，从而烧灼组织。电流在电极之间传导，并且烧灼、凝固或者接合压缩在其间 的组织。
另外，在开放手术和内窥镜手术中，例如外科缝合器和直线型切割器等的机械装置被用作切除组织和控制止血的装置。缝钉被用来在脉管结构中止血，并且当缝钉用于肺组织时，能够提供良好的静气压。外科切割器具有在可更换的钉仓中保持成多个交错排的多个缝钉。所述切割器压缩组织，缝钉被成形或者击发到接近待切除的患病组织部分的被压缩的组织中。切割刃纵向通过成形缝钉的最内两排之间，从而横断组织。从外科部位移除切割器，用另一个未击发的钉仓重新装载，重复手术直到所需的肺部被切除和移除为止。
采用这种形式的外科缝合器产生的一个已知的问题是会在切割和缝合的组织中形成小的“出血部位”。为了确保冷静，医生缝合或采用其它技术来对小的出血部位止血。RF能量装置和/或超声能量装置通常用来在内窥镜手术中切割和凝固组织。但是，将能量输送到金属缝钉排附近的组织需要细心和技巧。采用双极RF装置时，缝钉可导致短路，并且防止RF发生器击发和凝固组织。采用超声和/或单极装置时，与缝钉接触可将能量导离初始施加部位。
Yates等人的美国专利5735848、5688270和5709680披露了外科器械，其将缝钉施加内镜切割器和电外科双极RF装置结合来改善止血、降低手术复杂性和手术室时间。采用这些改进的双极切割和缝合装置时，夹紧扳机的启动使得组织与第一和第二电极接触；在通常用脚踏板对电外科发生器进行的启动时，由于RF能量的施加，产生窄的凝固组织带。第一电极、夹紧的组织以及第二电极形成导电回路。组织化学中的湿气和离子传导RF能量，并且组织开始变干或凝固。随着组织变干，组织的导电性越来越差。当组织完全干燥时，组织几乎是绝缘体并且只有少量的电流在第一和第二电极之间流动。外科器械上的第二击发扳机的启动使得缝钉排从单击发钉仓中击发到凝固带的两侧上，并且沿着凝固的组织的中心放置切割线。当外科器械打开时，组织切割线被沿着边缘烧灼以止血，并且将多排平行的缝钉放置在未烧灼的组织中以保证更加安全，所述未烧灼 的组织侧面与已烧灼的切割边缘相接。
如果需要更长的切割线，医生将第二钉仓重新装载到电外科缝合器械中，并且将其重新插入到患者所需部位中。然后重新夹紧器械，再启动发生器以产生第二凝固带。在一些情况下，希望将第二凝固带和缝合线放置在第一缝合线上方。当第二切割线相对于第一切割线倾斜时可发生这种情况。将端部执行器放置并夹紧在第一缝合线上方会通过使电外科缝合器的第一和第二电极经由一个或多个缝钉短路而形成“短路”状况。在任何情况下金属缝钉比组织更易于传导RF能量。当电极短路时，RF电流优选流过缝钉而不流过组织。由于短路，医生必须松开夹紧的器械并重新定位，将端部执行器重新夹紧在另一个位置。如果器械又短路，器械又必须被重新定位，直到短路消除为止。需要一种改进的电外科缝合装置，其通过减小导致短路的可能性而减少手术室时间。
另外，在将缝钉和RF能量输送结合的电外科装置中，RF能量的施加可由于塑料钉仓形成表面电荷。钉仓材料通常选择强度大、可模制、壁薄、尺寸精度高并且可重复使用的塑料。需要一种成本低的方式以减少钉仓的表面电荷。
作为另一种选择，希望采用RF能量的电容耦合以凝固组织。典型的双极RF电外科装置形成传导电阻网络以凝固组织。传导耦合装置也采用RF双极能量，但是将能量通过回路之间的互电容装置从一个回路传递到另一个回路。电容耦合RF双极电外科装置将不导电材料或电介质放置在组织和至少一个电极之间。能量从屏蔽电极向未屏蔽电极的传输是通过第一电极电介质、组织和第二电极回路之间的互电容进行的。
目前，还不存在能够满足所有上述需要的电外科器械。通过下面详细的说明和附图，这些和其他优点将变得更加清楚。
发明内容
根据本发明，提供一种电外科器械，具有能够在其中接收RF双 极能量的端部执行器。所述端部执行器包括第一电极和第二电极。电介质涂层可设置在所述第一电极和第二电极的至少一个上，电介质包括至少一个打开的通道穿过所述电介质涂层。电介质涂层中的至少一个打开的通道可为射频能量在所述第一电极和第二电极之间通过提供通路。
根据本发明，还提供一种电外科器械，具有用于夹紧和凝固组织的端部执行器。所述端部执行器包括第一电极和第二电极。电介质涂层可设置在所述第一电极和第二电极的至少一个上，其中电介质涂层可防止组织与有源电极的至少一个直接接触。
根据本发明的另一个实施例，提供一种电外科器械，具有端部执行器，所述端部执行器能够接收双极能量并能将至少一个缝钉放置到组织中。所述端部执行器包括：第一电极；第二电极；以及钉仓，其中具有所述至少一个缝钉。所述钉仓可具有涂层，以在将双极能量施加到组织上期间防止在钉仓上形成表面电荷。
本发明具体涉及：
(1)、一种电外科器械，具有能够在其中接收RF双极能量的端部执行器，所述端部执行器包括：
第一电极；
第二电极；以及
电介质涂层，其设置在所述第一电极和所述第二电极的至少一个上，至少一个打开的通道穿过所述电介质涂层，以为射频能量在所述第一电极和所述第二电极之间通过提供通路。
(2)、根据第(1)项所述的电外科器械，其中，所述第一电极和所述第二电极的至少一个中包括至少一个缝钉成形凹窝，所述至少一个缝钉成形凹窝中不存在电介质涂层，由此提供穿过所述电介质涂层的至少一个打开的通道。
(3)、根据第(2)项所述的电外科器械，其中，所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
(4)、根据第(3)项所述的电外科器械，其中，通过经由如下工艺中的一种或多种从所述第一电极和所述第二电极的至少一个选择地去除所述电介质涂层形成所述至少一个通道：
喷砂；
喷水；
研磨；或者
激光蚀刻。
(5)、根据第(3)项所述的电外科器械，其中，通过选择地掩蔽所述第一电极或所述第二电极的区域以防止电介质涂层粘附到其上而形成所述电介质通路。
(6)、根据第(2)项所述的电外科器械，其中，所述电外科器械包括至少一个缝钉，所述缝钉可在所述第一电极和所述第二电极中的一个上成形。
(7)、根据第(6)项所述的电外科器械，其中，所述缝钉具有电介质涂层。
(8)、根据第(2)项所述的电外科器械，其中，所述电介质涂层包括如下特征中的一项或多项：
基本上一致的厚度，或者
变化的厚度。
(9)、根据第(2)项所述的电外科器械，还包括刀，所述刀可穿过所述端部执行器运动。
(10)、一种电外科器械，具有用于夹紧和凝固组织的端部执行器，所述端部执行器包括：
位于所述端部执行器中的第一电极；
位于所述端部执行器中的第二电极；以及
电介质涂层，其覆盖所述第一电极和所述第二电极的至少一个，所述电介质涂层将非导电屏障设置在组织与所述第一电极和所述第二电极的至少一个之间。
(11)、根据第(10)项所述的电外科器械，其中，所述电介 质涂层在夹紧和凝固组织时形成电容耦合电路。
(12)、根据第(10)项所述的电外科器械，其中，覆盖所述第一电极和所述第二电极的至少一个的所述电介质涂层包括穿过其的至少一个打开的通路，用于使电能量在所述有源第一电极和第二电极之间直接通过。
(13)、根据第(10)项所述的电外科器械，其中，所述电能量是射频能量。
(14)、根据第(10)项所述的电外科器械，其中，所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
(15)、根据第(10)项所述的电外科器械，还包括刀，所述刀可穿过所述端部执行器运动。
(16)、一种电外科器械，具有端部执行器，所述端部执行器能够施加双极能量并能将至少一个缝钉放置到压缩在其中的组织中，所述端部执行器包括：
第一电极；
第二电极；以及
钉仓，其中具有所述至少一个缝钉，所述钉仓具有涂层，以在将双极能量施加到组织上期间防止在钉仓上形成表面电荷。
(17)、根据第(16)项所述的电外科器械，其中，所述涂层是电介质涂层，其包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
(18)、根据第(16)项所述的电外科器械，其中，所述钉仓上的所述涂层包括如下项中的一项或多项：
耐热涂层，或
光滑涂层。
(19)、根据第(16)项所述的电外科器械，其中，所述钉仓包括至少一个驱动器。
(20)、根据第(18)项所述的电外科器械，其中，所述至少 一个驱动器具有电介质涂层，以防止在其上形成表面电荷。
(21)、根据第(19)项所述的电外科器械，其中，所述驱动器上的所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
(22)、根据第(16)项所述的电外科器械，还包括刀，所述刀可穿过所述端部执行器运动。
(23)、根据第(16)项所述的电外科器械，还包括在所述至少一个缝钉上的电介质涂层，所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
(24)、一种电外科器械，具有端部执行器，所述端部执行器能够施加双极能量并能将至少一个缝钉放置到压缩在其中的组织中，所述端部执行器包括：
第一电极；
第二电极；以及
导电缝钉，其具有电介质涂层，所述电介质涂层防止所述缝钉与所述电外科能量导电接触。
(25)、根据第(24)项所述的电外科器械，其中，所述缝钉上的所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
附图说明
在后附权利要求书中具体限定了本发明的新颖特征。但是，通过参照下面的描述并结合附图将更好地理解本发明本身的结构、操作方法和其他目的和优点，其中：
图1是本发明的电外科器械的等轴测图，其示出了可操作地连接到致动脚踏开关上并连接到具有远侧端部执行器的电外科器械上的电外科发生器，所述端部执行器具有成角度打开的钉砧。
图2是图1所示电外科器械的端部执行器的侧视截面图，其示出了位于所述成角度打开的钉砧下方的未击发的第一钉仓以及钉砧上的涂层。
图3是图1所示端部执行器的截面端视图，其中钉砧处于关闭位置，该截面是沿着图2的线A-A截取，并示出了钉砧和钉仓涂层。
图4是现有技术的夹紧在组织上的端部执行器的截面端视图，示出了RF能量在电极之间的路径。
图5是端部执行器的截面图，其中带涂层的钉砧夹紧在组织上，该图示出了RF能量进入没有涂层的缝钉凹窝和通道中的路径。
图6是图4所示现有技术的端部执行器的等轴测图，该端部执行器被放置在包含多个成形缝钉的已切割的组织的一部分上，图4所示的现有技术的端部执行器被定位用于第二次夹紧、凝固，缝钉和切割线位于现有的缝合线顶部上。
图7是图6所示现有技术的端部执行器的截面图，该端部执行器被夹紧在包含多个成形缝钉的组织的一部分上，该图显示了成形在组织中的缝钉如何在第一电极和钉砧之间产生短路。
图8是图5所示端部执行器的截面图，该端部执行器被夹紧在包含多个成形缝钉的组织的一部分上，该图显示了钉砧涂层如何消除与成形缝钉的短路。
图9是本发明的涂层的替代实施例的视图，其中一部分涂层从钉砧的上表面移除。
图10显示了放置在钉砧上的本发明的第二替代实施例的钉砧涂层，其中钉砧涂层沿着组织接触区域没有开口。
图11显示了本发明的一种替代的E型梁(E-beam)电外科器械120。
图12是夹紧在包含一个成形缝钉的组织上的图11所示的E型梁端部执行器的截面图，其显示了钉砧涂层如何防止在第一电极和钉砧之间短路。
具体实施方式
如图1所示，本发明包括在外科手术进行中用于烧灼、凝固和/或组织接合的电外科器械，其整体用20表示。电外科器械20在组织上夹紧，可施加RF能量凝固组织，并且可被击发以放置多排平行的缝钉并切割最内两排缝钉之间的组织。这种类型的电外科器械在Yates等人的美国专利5735848、5688270和5709680中进行了描述，这些专利通过引用并入本文。但是，该电外科器械20可在端部执行器45上具有涂层改进，下面将进行详细描述。
电外科器械20具有手柄30和从手柄30向远侧延伸的轴40。端部执行器45从轴40的远端向远侧延伸。旋钮35位于手柄30和轴40之间，用于使轴40和端部执行器45绕纵向轴线L-L同时旋转。端部执行器45从轴40向远侧延伸并具有可动钉砧55和固定的下部通道47。钉砧55可从第一打开位置(图1)移动到第二夹紧或关闭位置(图3)，在第一打开位置与通道47成角度偏离，在第二夹紧或关闭位置与通道47平行并间隔开。包含多个缝钉53(图3)的钉仓50可拆卸地安装在通道47中。闭合扳机32和击发扳机34可转动地安装在手柄30内，位于握把31附近。致动闭合扳机32使扳机在握把31附近旋转，关闭钉砧55，并解锁击发扳机34。致动击发扳机34使多个缝钉53射出并使刀66在最内两排(未示出)缝钉53之间移动。释放按钮36位于手柄30的近端，用于将钉砧55从其关闭位置打开。
当医生启动脚踏开关22时，RF能量从电外科发生器21供应到电外科器械20。第一极线38和第二极线39将发生器21电连接到电外科器械20上，用于将RF能量输送到第一和第二电极。第一极线38和第二极线39从发生器延伸进入应变消除部37并分别到达端部执行器45中的第一电极和第二电极。
如图2所示，轴40具有可纵向移动的中空闭合管41和纵向固定的非导电保持器42，该保持器42由合适的材料制成，例如玻璃增强聚碳酸酯等。保持器42可转动地限制在手柄30中，并且被防止 纵向移动，但允许围绕纵向轴线L-L转动。通道47固定到保持器42的远端，并从闭合管41向远侧延伸，钉砧55可动地安装在其中。钉砧55可由导电材料例如不锈钢等制成，所示的钉砧55处于打开位置，与通道47和钉仓50成角度偏离。钉砧55包含多个缝钉成形凹窝58，当钉砧55关闭时(见图3)，这些缝钉成形凹窝58位于钉仓50中的缝钉53上方并与缝钉53对准。“C”形绝缘体62固定地安装在钉砧55的沟槽59(图3)中，第一电极60具有组织接触表面，并安装在“C”形绝缘体62的内部。绝缘体62使第一电极60和导电钉砧55电绝缘。第一极线38的远端与第一电极60形成电连接，近端与发生器21(图1)电连接。第一极线38与电外科器械20的所有元件之间电绝缘。缝钉成形钉砧55还用作用于本发明的电外科装置20的返回路径或第二电极56。通过启动闭合扳机32来关闭钉砧55。闭合扳机32可操作地连接到轴40的闭合管41上，并且使闭合管41从如图2所示的近侧位置向远侧运动。这种运动使闭合管41与钉砧55的斜面57接触，并且由于楔作用，使得钉砧55到达如图3所示的关闭位置。闭合管41也与通道47滑动电接触。本发明的钉砧55在选定的区域覆盖有电介质或非导电涂层75。如图2所示，钉砧55的斜面57没有涂覆涂层，以确保与闭合管41之间的导电路径。当闭合扳机32被启动时闭合管41与第二极线39电接触，以形成从发生器21到第二极钉砧55延伸的第二极电路。
击发扳机34的致动使得缝钉53从钉仓50中发射，从而使缝钉53在钉砧55上成形，并使得刀66沿着刀槽54移动，以切断最内两排缝钉之间的组织(动作未示出)。击发扳机34使楔形块51和刀66向远侧移过钉仓50，以抵靠钉砧55成形缝钉53。刀66连接到楔形块51并响应于击发扳机34的运动纵向移过钉仓50中的刀槽54和第一电极60(参见图3)。刀66跟随缝钉53的成形，因此组织首先被钉合然后被切割。图3是本发明的端部执行器45沿线A-A的截面端视图，其中钉砧55处于闭合位置，与钉仓50和通道47隔开并基本上和它们平行。参见图2可见端部执行器45上横截面A-A的 纵向位置。在图3中，经过缝钉凹窝58和电极沟槽59截取钉砧的横截面。本发明的电外科器械包括钉砧55上的不导电或介电的钉砧涂层75。例如，介电涂层75包括但不限于PTFE(聚四氟乙烯)、ParaleneTM或ParyleneTM、二氧化钛或环氧树脂。ParaleneTM或ParyleneTM是一系列对二甲苯基的聚合物的类名并且可从AdvanceCoating，10723 Edison Court，Rancho Cucamonga，CA91730获得。通过将对二甲苯(二聚物)在真空环境热解然后在连续真空下在冷却器(也就是常温)基板上沉积，形成聚对二甲苯。聚对二甲苯具有良好的电介质强度，以及特别高的表面和体积电阻率；并且电特性基本上和温度无关。其提供保形的无针孔涂层，该涂层具有极好的耐蚀性和绝缘保护性能。如果需要，涂层75可以被选择地涂覆在钉砧的所需区域上，或者钉砧可以被全部涂覆。如果需要，可通过激光蚀刻、喷砂、喷水、研磨等方式去除选定区域的涂层75。如图2所示，钉砧涂层75被选择地从斜面57去除或移除，以确保钉砧55和闭合管41之间的电导性。闭合管41电连接到从应变消除部37延伸到发生器21的第二极线39上，以完成第二极接地电路。钉砧55和通道47均通过与闭合管41接触而电连接到第二极线39上。在图3中，钉砧涂层75基本上围绕钉砧55延伸，但不延伸进入多个未涂覆的缝钉凹窝58，所述缝钉凹窝58向上延伸进入钉砧55。另外，涂层75在缝钉凹窝58附近具有变化的厚度。绝缘体62限制在沟槽59中并保持第一电极60。
钉仓50由工程热塑料例如液晶聚合物(LCP)VectraTM构成。驱动器52当被楔形块51向上推动时在钉仓50中垂直运动，以将缝钉53成形在钉砧凹窝58中。驱动器52也可由工程热塑料例如聚碳酸酯或液晶聚合物(LCP)VectraTM构成。一些工程热塑料经受RF能量时具有强的层表面电荷，所述电荷可将塑料暴露于高的热量中并且可产生电弧。本发明的一个目的是提供钉仓50和/或驱动器52上的钉仓涂层80。钉仓涂层80可以是电介质涂层，减小钉仓50上的表面电荷效应，并防止可能对钉仓热塑料造成损坏。另外，钉仓 涂层80可提供一定程度的热保护和/或增加钉仓50和驱动器52的光滑度，如果需要，可以通过掩蔽来去除或者通过激光蚀刻、喷砂、喷水、研磨等方式来移除。钉仓涂层80可以是PTFE(聚四氟乙烯)、ParaleneTM或ParyleneTM、二氧化钛或环氧树脂。
图4是Yate等人的美国专利5833690中披露的现有的端部执行器90的截面图，该专利通过引用并入本文。在图4中，现有技术的端部执行器90夹紧在组织70上，并且显示出了从第一电极94到第二电极95的电流路径。在本发明中，现有技术的钉砧91和现有技术的通道92通过与现有技术的闭合管93(未示出)接触形成现有技术的第二电极95(现有技术的钉砧91)。现有技术的钉仓96具有缝钉53、现有技术的驱动器97和现有技术的楔子98。
图5是本发明的端部执行器45的横截面视图，该端部执行器45夹紧在组织70上，RF能量施加到组织上。如图所示，优选的钉砧涂层75将电流重新导流到由未涂覆的缝钉凹窝58形成的第二电极56和未涂覆的通道47。
图6示出了打开的现有技术的端部执行器90，其放置于在进行第二次夹紧、凝固缝钉和切割线放置之前已经设置在组织中的缝钉线的顶部。如图所示，现有技术的器械的第一次击发使成形缝钉71沿着切割线在钉砧91中的第一和第二电极94和95的正下方延伸。新的包含缝钉53的钉仓50已经被装载以备击发。
图7示出了现有技术的钉砧91夹紧在包含一个成形缝钉71的组织上之后，图6的现有技术的端部执行器90。成形缝钉71直接与现有技术的第一电极94接触，并与第二电极95形成电短路。现有技术的第二电极92可容易地与缝钉71接触，并且可分别在现有技术的第一电极94和第二电极95之间导致短路状况。这种短路意味着医生必须松开器械，对其重新定位并且再将其夹紧。
图8是本发明的端部执行器45的截面图，该端部执行器45夹紧在包含一个成形缝钉71的组织70上。如图所示，钉砧涂层75防止成形缝钉71与位于缝钉凹窝58中的第二电极56和“U”形通道 47(在钉仓50下方延伸，参见图1)的暴露区域接触，并防止形成电短路。因此，优选实施例的缝钉涂层75允许电流通过组织流到缝钉凹窝58和通道47中，但是防止成形缝钉71容易地与第二电极56接触，并防止在端部执行器45中短路。电流路径可以通向缝钉凹窝58或通道47或者两者的结合。在存在缝钉71的情况下，电流路径也可从第一电极60到缝钉71然后到缝钉凹窝58和通道47。电能大部分流过最小电阻的路径，但一部分也流过电路中更高电阻的部分。通过电路中单个元件的电流可通过欧姆定律(V＝IR，其中V是电压，I是电流，R是电阻)计算。在存在成形缝钉71的情况下，最小电阻的电流路径(最大电流流过的路径)从第一电极60通过缝钉71经过组织70到凹窝58中。该路径在成形缝钉71附近凝固和干燥组织。由于缝钉71附近的组织70变干，使组织电阻更大，更小电流流到缝钉凹窝58。由于通过缝钉71和凹窝58的导电路径与电阻更大的凝固组织接触，在下一个最小电阻路径附近的未凝固的组织70开始凝固。
图9是本发明的涂层的替代实施例。在该实施例中，替代的钉砧涂层76在钉砧上表面55A、钉砧55的缝钉凹窝58和钉砧55的斜面57(参见图2)被掩蔽或者被移除。该替代实施例减小了替代的钉砧涂层76区域并减小了涂层76的材料成本，而不降低效果。
图10示出了钉砧55，替代的电容耦合涂层100或电介质涂层可在钉砧55的整个表面放置，除了斜面57(参见图2)的电接触区域之外。因此，从第一电极60经过组织70到第二电极85(例如钉砧55)的接触网络被钉砧55上的电容耦合钉砧涂层100阻断，并且组织凝固方法变成电容耦合。所示的第二电极56完全被涂覆，如果其与组织形成电容耦合电路，局部涂覆也可满足要求。电容的规则是，电容器具有的阻抗与频率成反比。换句话说，电容耦合优选传递信号的高频分量，并发现在RF电外科发生器频率大约300KHz到大约3MHz优选大约500KHz到大约700KHz之间工作良好。电容耦合在短距离例如电外科装置的电极之间工作良好。电容耦合涂层100可 以是电介质，包括但不限于PTFE(聚四氟乙烯)、ParaleneTM或ParyleneTM、二氧化钛或环氧树脂。
在图10中，组织70包含成形缝钉71，其与第一电极60直接接触，但是电容耦合涂层100防止其与第二电极56接触。钉砧55和第二电极56可具有较大的基本上平的部分，电容耦合涂层100防止该部分与组织70形成直接接触电路。第二电极56的表面积大于第一电极60的表面积。具有至少一个较大表面积电极(第二电极56)和一个较小表面积电极(第一电极60)的电容耦合电路可具有微妙的但不同的效应。该效应按如下方式工作。组织中的电外科能量密度的阈值必须在组织效应发生之前被满足。当能量密度低于该阈值时，能量的施加对组织没有影响。当能量密度上升高于该阈值时，组织受能量影响并开始加热或热处理。在根据本发明的第二替代钉砧涂层100的情况下，能量密度散布在第一和第二电极60和56之间，与两个磁体之间的磁力线有些类似。这将能量密度集中在第一电极60上并跨过第二电极56的水平表面散布或冲淡场线。当较小的金属物体例如成形缝钉71位于上述电容电路的组织70中时，电容耦合RF能量可忽略导电缝钉71的小区域作为最小电阻路径。这意味着与接触RF电路不同，电容耦合凝固可发生在第一电极附近，不在成形缝钉71周围。
图11示出了替代的E型梁电外科器械120。E型梁电外科器械120在操作上与先前描述的电外科器械20类似。也就是说，两种电外科器械都是夹紧、施加RF能量、在组织中形成多排缝钉、在最内两排缝钉之间切割组织。E型梁电外科器械120分别具有第一和第二极E型梁线138和139。这些E型梁线138和139可通过连接器140连接到发生器21和脚踏开关22(参见图1)上，以将RF能量输送到E型梁端部执行器145。替代的电外科器械120的E型梁端部执行器145在原电外科器械20基础上具有一些机械改进。
如图12所示，替代的电外科器械120具有E型梁165，其在击发期间通过端部执行器145延伸，以在E型梁钉砧155和E型梁通 道147之间保持均匀的组织间隙。E型梁165具有：上支撑部167，其在钉砧槽(在围绕上支撑部167的钉砧155中)中延伸；下支撑部169，其在通道槽148下方延伸；以及中支撑部168，其沿着E型梁通道147的内表面延伸。E型梁上支撑部167和E型梁下支撑部169将E型梁钉砧155和E型梁通道147在垂直方向连接在一起，防止端部执行器145从厚组织扩展。E型梁上支撑部167和E型梁中支撑部168防止E型梁端部执行器145在夹紧在薄组织上时聚到一起。由于E型梁钉仓150安装在E型梁通道147中，E型梁钉仓150和E型梁钉砧155之间的间隙也被保持。E型梁电外科器械例如E型梁电外科器械120在本领域是已知的，如Shelton等人在2003年5月20日提交的美国专利公开20040232196中对其进行了描述，该专利公开通过引用并入本文。
E型梁机构使得必须在电外科器械20的第一电极60、绝缘体62和第二电极56的设计方面作出改变。如图11所示，E型梁电外科器械120的电极设计具有安装在E型梁绝缘体162上的一对E型梁第一电极160。E型梁钉砧155用作E型梁第二电极156。所示的组织70夹紧在E型梁端部执行器145中，成形缝钉71与E型梁第一电极160之一接触并与E型梁钉砧涂层175接触。E型梁钉砧涂层175防止成形缝钉71与E型梁第二电极156接触。E型梁钉仓涂层180防止在E型梁钉仓150的上形成表面电荷。
尽管上述缝合装置是直的，本领域技术人员容易理解，可将涂层施加到任何形状的任何缝合装置的钉砧和钉仓上，包括但不限于圆形致动器。作为另一种选择，用在身体中的缝钉或者其他导电紧固件也可以涂覆电介质涂层，电介质涂层使得缝钉在经受电外科能量时不导电。电介质缝钉涂层包括但不限于PTFE(聚四氟乙烯)、ParaleneTM或ParyleneTM、二氧化钛或环氧树脂。
应当理解，等同的结构可以用于替代这里描述和例举的结构，所描述的本发明的实施例不是可以实施所要求保护的本发明的唯一结构。作为可以用于实施本发明的等同结构的一个例子，例如PTFE 的涂层可在双极电外科装置中用作电介质涂层。作为可以用于实施本发明的等同结构的另一个例子，例如具有对位二甲苯基的聚合物的涂层的替代涂层可在双极电外科装置中用作电介质涂层。
尽管在这里已经显示和描述了本发明的优选实施例，但是本领域技术人员了解这些实施例只是以举例的方式提供。本领域技术人员在不背离本发明的情况下可作出各种变型、改变和替代。因此，本发明仅由后附权利要求的精神和范围限定。
Claims (9)
1.一种电外科器械，具有能够夹紧在组织上并在其中接收RF双极能量的端部执行器，所述端部执行器包括：
a)第一电极，具有第一组织接触表面；
b)第二电极，具有第二组织接触表面，且具有多个凹窝；以及
c)电介质涂层，其横过所述第二组织接触表面设置在所述第二电极上并进入所述多个凹窝，至少一个打开的通道凹入所述多个凹窝并延伸穿过所述电介质涂层，以为射频能量在所述第一电极和所述第二电极之间通过提供通路，其中在没有组织的情况下夹紧所述端部执行器时，所述第一电极和所述第二电极被构造成防止两者之间的短路接触，在具有导电物体的情况下夹紧所述端部执行器时，所述第一电极和所述第二电极以及所述电介质涂层被构造成防止所述至少一个导电物体使得所述第一电极和所述第二电极直接短路。
2.根据权利要求1所述的电外科器械，其中，所述第一电极和所述第二电极的至少一个中包括至少一个缝钉成形凹窝，所述至少一个缝钉成形凹窝中不存在电介质涂层，由此提供穿过所述电介质涂层的至少一个打开的通道。
3.根据权利要求1所述的电外科器械，其中，所述电介质涂层包括选自以下组的至少一种涂层：聚四氟乙烯、对位二甲苯基的一系列聚合物的至少一种、二氧化钛和环氧树脂。
4.根据权利要求3所述的电外科器械，其中，所述至少一个打开的通道位于所述第一电极和所述第二电极的至少一个上的所述电介质涂层内，并且以如下方式形成：
a)所述至少一个打开的通道通过喷砂被蚀刻穿过所述电介质涂层；
b)所述至少一个打开的通道通过喷水被蚀刻穿过所述电介质涂层；
c)所述至少一个打开的通道通过研磨穿过所述电介质涂层；或者
d)所述至少一个打开的通道通过激光蚀刻被蚀刻穿过所述电介质涂层。
5.根据权利要求3所述的电外科器械，其中，通过选择性地掩蔽所述第一电极或所述第二电极的区域以防止电介质涂层粘附到其上而形成所述至少一个打开的通道。
6.根据权利要求2所述的电外科器械，其中，所述电外科器械包括至少一个导电缝钉，所述导电缝钉可在所述第一电极和所述第二电极的至少一个上成形。
7.根据权利要求6所述的电外科器械，其中，所述导电缝钉具有电介质涂层。
8.根据权利要求1所述的电外科器械，其中，所述电介质涂层包括：
a)基本上一致的厚度，或者
b)变化的厚度。
9.根据权利要求1所述的电外科器械，还包括刀，所述刀可穿过所述端部执行器运动。
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| US20080077131A1 (en) | 2008-03-27 |
| CN101147695A (zh) | 2008-03-26 |
| US7780663B2 (en) | 2010-08-24 |
| EP1905370A1 (en) | 2008-04-02 |
| HK1115290A1 (en) | 2008-11-28 |
| EP1905370B1 (en) | 2012-06-27 |
| JP5106962B2 (ja) | 2012-12-26 |
| JP2008073531A (ja) | 2008-04-03 |
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