CN107809976B - 具有用户自适应算法的外科器械 - Google Patents

具有用户自适应算法的外科器械 Download PDF

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CN107809976B
CN107809976B CN201680038314.8A CN201680038314A CN107809976B CN 107809976 B CN107809976 B CN 107809976B CN 201680038314 A CN201680038314 A CN 201680038314A CN 107809976 B CN107809976 B CN 107809976B
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generator
surgical
end effector
power output
tissue
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CN107809976A (zh
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R·M·亚瑟
C·N·法勒
C·J·谢伊布
P·F·里斯坦伯格
J·S·吉
B·M·博伊德
B·D·迪克森
R·J·瑞兹奥尔蒂兹
W·B·威森伯格二世
T·C·加尔迈耶
J·A·希布纳
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Ethicon LLC
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Abstract

各种形式涉及用于组织的解剖和凝固的系统和方法。外科器械包括被构造成能够在其远侧端部处解剖和密封组织的端部执行器以及具有多个外科模式的选择器开关。发生器电联接到所述外科器械并且被构造成能够将能量传送到所述端部执行器。所述选择器开关的每个外科模式对应于用于控制从所述发生器传送到所述端部执行器的功率的算法，并且对应于所述多个外科模式的每个算法能够允许用户控制所述发生器的功率输出水平。

Description

具有用户自适应算法的外科器械
技术领域
本公开一般涉及超声外科系统，并且更具体地，涉及允许外科医生执行切割和凝固并且调整和定制用于执行此类规程的算法的超声和电外科系统。
背景技术
超声外科器械凭借此类器械的独特性能特性而在外科规程中得到日益广泛的应用。根据具体器械构型和操作参数，超声外科器械能够基本上同时进行组织的切割和通过凝固的止血，从而有利地使患者创伤最小化。切割动作通常通过器械的远侧端部处的端部执行器或刀头来实现，所端部执行器或刀头将超声能量传输到与该端部执行器接触的组织。这种性质的超声器械可被构造用于开放性外科手术用途、腹腔镜式或内窥镜式外科规程，包括机器人辅助规程。
一些外科器械将超声能量同时用于精确切割和受控凝固。与电外科手术使用的温度相比，超声能量使用更低的温度来切割和凝固。通过高频振动(例如，每秒55,500次)，超声刀使组织中的蛋白变性以形成粘性凝固物。刀表面施加到组织上的压力使血管塌缩并且允许凝固物形成止血密封。切割和凝固的精度受外科医生的技术以及对功率水平、刀刃、组织牵引力和刀压力的调节的控制。
用于将电能施加到组织以治疗和/或破坏组织的电外科装置也在外科规程中得到日益广泛的应用。电外科装置通常包括手持件，所述手持件为具有远侧安装的端部执行器(例如，一个或多个电极)的器械。所述端部执行器可抵靠组织定位，使得电流被引入组织中。电外科装置可被构造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电极被引入组织中并且通过单独设置在患者身体上的返回电极(例如，接地垫)返回。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。电外科装置的端部执行器也可包括能够相对于组织运动的切割构件以及用以横切组织的电极。
由电外科装置施加的电能可通过与手持件连通的发生器传递至器械。电能可为射频(“RF”)能量的形式。RF能量为可在300千赫兹(kHz)至1兆赫兹(MHz)频率范围内的电能形式。在应用中，电外科装置可穿过组织传递低频射频能，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。由于受影响的组织与周围组织之间形成明显的边界，因此外科医生能够以高精确度进行操作，并在不损伤相邻的非目标组织的情况下进行控制。射频能的低操作温度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能量尤其奏效地适用于结缔组织，所述结缔组织主要由胶原构成并且在接触热时收缩。
使用这些医疗装置的挑战在于不能根据正在被执行的规程的类型来控制和定制功率输出。期望提供一种克服当前器械的某些缺陷的外科器械。本文所述的外科系统能够克服这些缺陷。
附图说明
所述形式的新型特征部在随附权利要求书中具体阐述。然而，关于组织和操作方法的所述形式可通过结合附图参照以下描述最好地理解，其中：
图1示出了包括发生器和可与其一起使用的各种外科器械的外科系统的一种形式；
图2为图16的超声外科器械的图；
图3为图16的外科系统的图；
图4为示出一种形式中的动态支路电流的模型；
图5为一种形式中的发生器架构的结构视图；
图6示出了发生器的驱动系统的一种形式，该驱动系统产生用于驱动超声换能器的超声电信号；
图7示出了包括组织阻抗模块的发生器的驱动系统的一种形式；
图8示出了外科器械的在其上具有选择器开关用于选择外科模式的一种形式；
图9为用于选择外科模式的逻辑流程图，该外科模式对应于可在发生器的一种形式中实施的组织算法；
图10为用于定制对应于组织算法的外科模式的逻辑流程图；
图11为用于选择对应于组织算法的外科模式的逻辑流程图的一种形式，该组织算法将外科器械的端部执行器的位置用作算法输入；
图12为用于选择对应于组织算法的外科模式的逻辑流程图的另一种形式，该组织算法将外科器械的端部执行器的位置用作算法输入；并且
图13为用于定制对应于包括计数器的组织算法的外科模式的逻辑流程图，该计数器用于计算外科器械的端部执行器的闭合次数。
具体实施方式
在详细说明超声外科器械的各种形式之前，应该指出的是，示例性形式的应用或使用并不局限于附图和具体实施方式中所示出的部件的构造和布置的细节。示例性形式可以单独实施，也可以与其它形式、变型和修改结合在一起实施，并可以通过多种方式实践或执行。此外，除非另外指明，否则本文所用的术语和表达是为了方便读者而对示例性形式进行描述目的所选的，并非为了限制性的目的。
此外，应当理解，下述形式、形式表达、示例中的任何一个或多个可与下述其它形式、形式表达和示例中的任何一个或多个组合。
各种形式均涉及改进的超声外科器械，其被构造用于在外科规程中执行组织解剖、切割和/或凝固。在一种形式中，超声外科器械设备被构造用于开放性外科规程中，但所述设备也可应用于其它类型手术中，例如腹腔镜式、内窥镜式和机器人辅助规程。通过选择性地使用超声能量，方便了多种用途。
将结合本文所述的超声器械描述各种形式。此类说明以举例而非限制性的方式提供，并且不旨在限制其范围和应用。例如，所述形式中的任一个可结合多个超声器械使用，所述多个超声器械包括例如美国专利5,938,633；5,935,144；5,944,737；5,322,055；5,630,420；和5,449,370描述的那些。
通过以下说明将变得显而易见的是，设想本文所述的外科器械的形式可与外科系统的振荡器单元相关联地使用，由此振荡器单元的超声能量为当前的外科器械提供期望的超声致动。还设想，本文所述的外科器械的形式可与外科系统的信号发生器单元相关联地使用，由此例如射频(RF)形式的电能被用来为与外科器械有关的用户提供反馈。超声振荡器和/或信号发生器单元可与外科器械不可拆卸地一体化，或者可被提供为可电附接到外科器械的单独部件。
本外科设备的一种形式由于其简单构造而被特别构造用于一次性使用。然而，还设想本外科器械的其它形式可被构造用于非一次性或多次使用。仅出于例证性目的，当前公开了本外科器械与相关联的振荡器和信号发生器单元的可拆卸连接供单个患者使用。然而，还设想了本外科器械与相关联的振荡器和/或信号发生器单元的不可拆卸的一体式连接。因此，当前所述的外科器械的各种形式可被构造用于与可拆卸的和/或不可拆卸的一体化振荡器和/或信号发生器单元一起用于单次使用和/或多次使用，然而并非仅限于此，而是这些构型的所有组合均被设想为落入本公开的范围内。
参考图1-5，示出了包括超声外科器械的外科系统10的一种形式。图1示出了包括发生器1002和可与其一起使用的各种外科器械1004、1006的外科系统10的一种形式。图2为图1的超声外科器械1004的图。发生器1002可被构造成能够与外科装置一起使用。根据各种形式，发生器1002可被构造成能够与不同类型的不同外科装置一起使用，所述外科装置包括例如超声装置1004和电外科或射频外科装置(例如射频装置1006)。尽管在图1的形式中，发生器1002被示为与外科装置1004、1006分开，但在一种形式中，发生器1002可与外科装置1004、1006中的任一个形成为一体，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可包括生成适于对发生器1002的操作进行编程的信号的任何合适的装置。
图3为图1的外科系统10的图。在各种形式中，发生器1002可包括若干独立的功能性元件，诸如模块和/或块。不同的功能性元件或模块可被构造用于驱动不同种类的外科装置1004、1006。例如，超声发生器模块1008可驱动超声装置，例如超声装置1004。电外科/射频发生器模块1010可驱动电外科装置1006。例如，相应的模块1008、1010可生成用于驱动外科装置1004、1006的相应的驱动信号。在各种形式中，超声发生器模块1008和/或电外科/射频发生器模块1010各自可与发生器1002形成为一体。另选地，模块1008、1010中的一个或多个可被设置成电耦合到发生器1002的单独的电路模块。(模块1008和1010以虚线显示以示出此部分。)此外，在一些形式中，电外科/射频发生器模块1010可与超声发生器模块1008形成为一体，或反之亦然。此外，在一些形式中，发生器1002可完全省去且模块1008、1010可由相应器械1004、1006内的处理器或其它硬件来执行。
根据所述形式，超声发生器模块1008可产生特定电压、电流和频率(例如，55,500周期/秒(Hz))的一个或多个驱动信号。所述一个或多个驱动信号可被提供至超声装置1004、尤其是可例如如上所述进行操作的换能器1014。换能器1014和延伸穿过轴1015的波导(图2中未示出波导)可共同地形成驱动端部执行器1026的超声刀1017的超声驱动系统。在一种形式中，发生器1002可被构造成能够生成特定电压、电流和/或频率输出信号的驱动信号，所述驱动信号可阶跃或换句话讲修改为具有高分辨率、精度和再现性。
发生器1002可被启动以按照任何合适的方式将驱动信号提供到换能器1014。例如，发生器1002可包括脚踏开关1020，所述脚踏开关1020通过脚踏开关缆线1022联接到发生器1002。临床医生可通过压下脚踏开关1020来启动换能器1014。此外，或作为脚踏开关1020的替代，超声装置1004的一些形式可利用定位于手持件上的一个或多个开关，当被启动时，所述一个或多个开关可使发生器1002启动换能器1014。在一种形式中，例如，所述一个或多个开关可包括一对切换钮1036a、1036b(图2)例如以确定装置1004的操作模式。当切换钮1036a被压下时，例如，超声发生器1002可将最大驱动信号提供到换能器1014，从而使其产生最大超声能量输出。压下切换钮1036b可导致超声发生器1002将用户可选的驱动信号提供到换能器1014，从而使其产生小于最大值的超声能量输出。除此之外或另选地，装置1004可包括第二开关(未示出)以例如指示用于操作端部执行器1026的钳口的钳口闭合触发器的位置。此外，在一些形式中，超声发生器1002可基于钳口闭合触发器的位置被启动(例如，当临床医生压下钳口闭合触发器以闭合钳口时，可施加超声能量)。
除此之外或另选地，所述一个或多个开关可包括切换钮1036c，所述切换钮1036c在被压下时导致发生器1002提供脉冲输出。脉冲例如可按任何合适的频率和分组提供。在某些形式中，例如，脉冲的功率水平可为与切换钮1036a、1036b相关联的功率水平(最大值、小于最大值)。
应当理解，装置1004可包括切换钮1036a、1036b、1036c的任意组合。例如，装置1004可被构造成能够具有仅如下两个切换钮：切换钮1036a和切换钮1036c，切换钮1036a用于产生最大超声能量输出，并且切换钮1036c用于产生最大功率水平或小于最大功率水平的脉冲输出。以此方式，发生器1002的驱动信号输出件配置可为5个连续信号和5或4或3或2或1个脉冲信号。在某些形式中，例如可基于发生器1002中的EEPROM设定和/或用户功率水平选择来控制特定的驱动信号配置。
在某些形式中，可提供双位开关来替代切换钮1036c。例如，装置1004可包括用于产生最大功率水平的连续输出的切换钮1036a和双位切换钮1036b。在第一止动位置中，切换钮1036b可产生小于最大功率水平的连续输出，并且在第二止动位置中，切换钮1036b可产生脉冲输出(例如，根据EEPROM设定，具有最大功率水平或小于最大功率水平)。
根据所述形式，电外科/射频发生器模块1010可生成具有足以使用射频(RF)能执行双极性电外科手术的输出功率的一个或多个驱动信号。在双极性电外科应用中，例如驱动信号可被提供至例如电外科装置1006的电极。因此，发生器1002可被构造用于通过将足以治疗组织(例如，凝固、烧灼、组织焊接)的电能施加到组织而达到治疗目的。
发生器1002可包括位于例如发生器1002的控制台的前面板上的输入装置1045(图1)。输入装置1045可包括产生适于对发生器1002的操作进行编程的信号的任何合适的装置。在操作中，用户可使用输入装置1045对发生器1002的操作进行编程或以其它方式进行控制。输入装置1045可包括生成可由发生器(例如，由包含在发生器中的一个或多个处理器)用于控制发生器1002的操作(例如，超声发生器模块1008和/或电外科/射频发生器模块1010的操作)的信号的任何合适的装置。在各种形式中，输入装置1045包括钮、开关、指轮、键盘、小键盘、触摸屏显示器、指点装置中的一种或多种，所述输入装置远程连接到通用或专用计算机。在其它形式中，输入装置1045例如可包括合适的用户界面，例如显示于触摸屏显示器上的一个或多个用户界面屏幕。因此，通过输入装置1045，用户可设定发生器的各种操作参数或对其进行编程，例如由超声发生器模块1008和/或电外科/RF发生器模块1010生成的一个或多个驱动信号的电流(I)、电压(V)、频率(f)和/或周期(T)。
发生器1002还可包括输出装置1047(图1)，例如，位于发生器1002的控制台的前面板上的输出指示器。输出装置1047包括用于为用户提供感观反馈的一个或多个装置。此类装置可包括例如视觉反馈装置(例如，视觉反馈装置可包括白炽灯、发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器、LCD显示屏、LED指示器)、听觉反馈装置(例如，听觉反馈装置可包括扬声器、蜂鸣器、可听见的计算机产生的音调、经计算机处理的语言、通过语音/语言平台与计算机进行交互的语音用户界面(VUI))或触觉反馈装置(例如，触觉反馈装置包括任何类型的振动反馈、触觉致动器)。
尽管可通过举例来描述发生器1002的某些模块和/或块，但可理解，可使用更多或更少数目的模块和/或块，并仍在所述形式的范围内。此外，尽管各种形式可按照模块和/或块的形式描述以有利于说明，然而这些模块和/或块可通过一个或多个硬件部件和/或软件部件和/或硬件部件和软件部件的组合加以实施，所述硬件部件为例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器，所述软件部件为例如程序、子程序、逻辑。另外，在一些形式中，可利用定位在器械1004、1006(即，可省去发生器1002)内的类似硬件来实施本文所述的各种模块。
在一种形式中，超声发生器驱动模块1008和电外科/射频驱动模块1010可包括作为固件、软件、硬件或它们的任意组合实施的一个或多个嵌入式应用程序。模块1008、1010可包括各种可执行模块，例如软件、程序、数据、驱动器、应用程序接口(API)等。固件可存储在非易失性存储器(NVM)(诸如位屏蔽只读存储器(ROM)或闪速存储器)中。在各种具体实施中，将固件存储在ROM中可保护闪存存储器。NVM可包括其它类型的存储器，包括例如可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM)(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一种形式中，模块1008、1010包括硬件部件，所述硬件部件作为用于执行程序指令实施的处理器用于监视装置1004、1006的各种可测量特性并生成用于操作装置1004、1006的对应输出控制信号。在其中发生器1002与装置1004结合使用的形式中，输出控制信号能够以切割和/或凝固操作模式驱动超声换能器1014。装置1004和/或组织的电特性可被测量并且用于控制发生器1002的操作方面和/或可作为反馈提供给用户。在其中发生器1002与装置1006结合使用的形式中，输出控制信号可将电能(例如，RF能量)提供给切割、凝固和/或脱水模式中的端部执行器1032。装置1006和/或组织的电特性可被测量并且用于控制发生器1002的操作方面和/或可为用户提供反馈。在各种形式中，如在前所述，硬件部件可作为DSP、PLD、ASIC、电路和/或寄存器实施。在一种形式中，处理器可被构造成能够存储和执行计算机软件程序指令，以生成用于驱动装置1004、1006的各种部件(例如超声换能器1014和端部执行器1026、1032)的阶跃函数输出信号。
图4示出了根据一种形式的超声换能器诸如超声换能器1014的等效电路1050。电路1050包括第一“动态”支路和第二电容支路，所述第一“动态”支路具有串联连接并限定谐振器的机电性能的电感Ls、阻抗Rs和电容Cs，所述第二电容支路具有静电容Co。可在驱动电压Vg下从发生器接收驱动电流Ig，其中动态电流Im流过第一支路并且电流Ig-Im流过电容支路。可通过适当地控制Ig和Vg来实现超声换能器的机电特性的控制。如上所述，常规发生器架构可包括调谐电感器Lt(在图4中以虚线显示)用于在并联谐振电路中将静电容Co调谐成谐振频率，使得基本上所有发生器的电流输出Ig全部流过动态支路。以此方式，通过控制发生器电流输出Ig来实现动态支路电流Im的控制。然而，调谐电感器Lt对超声换能器的静电容Co是特定的，并且具有不同静电容的不同超声换能器需要不同的调谐电感器Lt。此外，因为调谐电感器Lt与静电容Co在单谐振频率下的标称值相匹配，所以仅在所述频率下才能确保对动态分支电流Im的精确控制，并且当频率随着换能器温度向下偏移时，对动态支路电流的精确控制会折中。
发生器1002的形式并不依赖于调谐电感器Lt来监视动态支路电流Im。相反，发生器1002可在用于特定超声外科装置1004的功率的应用(连同驱动信号电压和电流反馈数据)之间使用静电容Co的测量值，以在动态行进的基础上(例如，实时地)确定动态支路电流Im的值。因此，发生器1002的这些形式能够提供虚拟调谐，以模拟被调谐的系统或在任何频率下的任何静电容Co值进行谐振，而非仅静电容Co的标称值所指示的单谐振频率。
图5为发生器1002的一种形式的简化方框图，所述发生器如上所述除提供其它有益效果之外还提供无电感器调谐。发生器1002的另外的细节在共同转让的名称为“Surgical Generator For Ultrasonic And Electrosurgical Devices”的美国专利申请序列号12/896,360(现为美国专利9,060,775)中有所描述，该专利的公开内容全文以引用方式并入本文。参照图5，发生器1002可包括患者隔离台1052，所述患者隔离台通过功率变压器1056与非隔离台1054通信。功率变压器1056的次线圈1058包含在隔离台1052中并可包括分接构型(例如，中心分接或非中心分接构型)来限定驱动信号输出件1060a、1060b、1060c用于将驱动信号输出到不同的外科装置，诸如，超声外科装置1004和电外科装置1006。具体地，驱动信号输出件1060a、1060c可将超声驱动信号(例如，420V RMS驱动信号)输出到超声外科装置1004，并且驱动信号输出件1060b、1060c可将电外科驱动信号(例如，100V RMS驱动信号)输出到电外科装置1006，其中输出1060b对应于功率变压器1056的中心分接头。
在某些形式中，超声驱动信号和电外科驱动信号可同时提供至不同的外科器械和/或具有将超声能和电外科能两者传递至组织的能力的单个外科器械。应当理解，提供至专用电外科器械和/或提供至组合超声/电外科器械的电外科信号可为治疗水平信号或亚治疗水平信号。
非隔离台1054可包括功率放大器1062，所述功率放大器具有连接到功率变压器1056的主线圈1064的输出。在某些形式中，功率放大器1062可包括推挽放大器。例如，非隔离台1054还可包括逻辑装置1066用于对数字/模拟转换器(DAC)1068提供数字输出，而所述数字/模拟转换器(DAC)又将对应的模拟信号提供至功率放大器1062的输入。在某些形式中，例如除其它逻辑电路之外，逻辑装置1066可包括可编程的门阵列(PGA)、现场可编程的门阵列(FPGA)、可编程的逻辑装置(PLD)。因此，通过经由DAC 1068控制功率放大器1062的输入，逻辑装置1066可控制在驱动信号输出件1060a、1060b、1060c处出现的驱动信号的多个参数(例如，频率、波形形状、波形振幅)中的任一个。在某些形式中并且如下所述，逻辑装置1066结合处理器(例如，下文所述的数字信号处理器)可实施多个基于数字信号处理(DSP)的算法和/或其它控制算法，以控制发生器1002所输出的驱动信号的参数。
可通过开关模式调节器1070将功率提供至功率放大器1062的功率轨。在某些形式中，开关模式调节器1070例如可包括可调式降压调节器。例如，非隔离台1054还可包括第一处理器1074，在一种形式中，所述第一处理器可包括DSP处理器，例如可从Analog Devices(Norwood,MA)购得的Analog Devices ADSP-21469SHARC DSP，但可在各种形式中采用任何合适的处理器。在某些形式中，处理器1074可响应于由DSP处理器1074通过模拟/数字转换器(ADC)1076从功率放大器1062接收的电压反馈数据来控制开关模式功率转换器1070的操作。在一种形式中，例如，DSP处理器1074可通过ADC 1076作为输入接收由功率放大器1062放大的信号(例如，RF信号)的波形包络。随后，DSP处理器1074可控制开关模式调节器1070(例如，通过脉宽调制(PWM)输出)，使得被提供到功率放大器1062的干线电压跟踪经放大的信号的波形包络。通过基于波形包络以动态方式调制功率放大器1062的干线电压，功率放大器1062的效率相对于固定干线电压放大器方案可显著升高。
在某些形式中，逻辑装置1066结合DSP处理器1074可实施直接数字合成器(DDS)控制方案，以控制发生器1002所输出驱动信号的波形形状、频率和/或振幅。在一种形式中，例如逻辑装置1066可通过召回存储于动态更新的查找表(LUT)(例如RAM LUT)中的波形样本来实施DDS控制算法，所述动态更新的查找表可被嵌入FPGA中。该控制算法尤其可用于如下超声应用，其中超声换能器诸如超声换能器1014可由谐振频率下的纯正弦式电流驱动。因为其它频率可激发寄生谐振，因此最小化或降低动态支路电流的总失真可相应地最小化或降低不利的谐振效应。因为发生器1002所输出的驱动信号的波形形状受输出驱动电路(例如，功率变压器1056、功率放大器1062)中所存在的各种畸变源的影响，所以基于驱动信号的电压和电流反馈数据可被输入到算法(例如由DSP处理器1074实施的误差控制算法)中，所述算法通过适当地以动态行进方式(例如，实时地)使存储于LUT中的波形样本预先畸变或修改来补偿畸变。在一种形式中，对LUT样本所施加的预先畸变量或程度可根据所计算的动态支路电流与期望的电流波形形状之间的误差而定，其中所述误差可基于逐一样本确定。以此方式，预先畸变的LUT样本在通过驱动电路被处理时，可使动态支路驱动信号具有所期望的波形形状(例如，正弦形状)，以最佳地驱动超声换能器。因此，在此类形式中，当考虑到畸变效应时，LUT波形样本将不呈现驱动信号的期望波形形状，而是呈现要求最终产生动态支路驱动信号的期望波形形状的波形形状。
非隔离台1054还可包括ADC 1078和ADC 1080，所述ADC 1078和ADC 1080经由相应的隔绝变压器1082、1084联接到功率变压器1056的输出，以分别用于对发生器1002所输出的驱动信号的电压和电流进行采样。在某些形式中，ADC 1078、1080可被构造成能够高速(例如，80MSPS)采样，以能够对驱动信号进行过采样。在一种形式中，例如ADC 1078,1080的采样速度可实现驱动信号的约200x(根据频率而定)的过采样。在某些形式中，可通过令单个ADC通过二路式多路复用器接收输入电压和电流信号来执行ADC1078、1080的采样操作。通过在发生器1002的形式中使用高速采样，除可实现其它事物之外，还可实现对流过动态支路的复杂电流的计算(这在某些形式中可用于实施上述基于DDS的波形形状控制)、对采样信号进行精确的数字滤波、以及以高精度计算实际功耗。ADC 1078、1080所输出的电压和电流反馈数据可由逻辑装置1066接收及处理(例如，FIFO缓冲、多路复用)并被存储于数据存储器中供例如DSP处理器1074后续取回。如上所述，电压和电流反馈数据可用作算法的输入用于以动态行进方式使LUT波形样本预先畸变或修改。在某些形式中，当采集到电压和电流反馈数据对时，可能需要基于由逻辑装置1066输出的对应LUT样本或换句话讲与所述对应LUT样本相关联，为每一所存储的电压和电流反馈数据对进行编索引。以此方式使LUT样本和电压和电流反馈数据同步有助于预失真算法的准确计时和稳定性。
在某些形式中，可使用电压和电流反馈数据来控制驱动信号的频率和/或振幅(例如，电流振幅)。在一种形式中，例如，可使用电压和电流反馈数据来确定阻抗相位。随后，可控制驱动信号的频率以最小化或减小所确定阻抗相位与阻抗相位设定点(例如，0°)之间的差值，从而最小化或减小谐波畸变的影响，并相应地提高阻抗相位测量精确度。相位阻抗和频率控制信号的确定可在DSP处理器1074中实现，例如，其中频率控制信号作为输入被提供至逻辑装置1066所实施的DDS控制算法。
在另一形式中，例如可监视电流反馈数据，以便将驱动信号的电流振幅保持在电流振幅设定点。电流振幅设定点可被直接指定或基于特定的电压振幅和功率设定点而间接地确定。在某些形式中，例如可通过处理器1074中的控制算法(例如，PID控制算法)来实现对电流振幅的控制。控制算法为了适当控制驱动信号的电流振幅而控制的变量可包括例如：存储在可编程逻辑器件1066中的LUT波形样本的定标和/或借助DAC 1086的DAC 1068(其为功率放大器1062提供输入)的最大定标输出电压。
非隔离台1054还可包括第二处理器1090用于除别的之外还提供用户界面(UI)功能。在一种形式中，UI处理器1090可包括例如购自Atmel公司(San Jose,CA)的具有ARM926EJ-S核的Atmel AT91SAM9263处理器。UI处理器1090所支持的UI功能的示例可包括听觉和视觉用户反馈、与外围装置(例如，通过通用串行总线(USB)接口)的通信、与脚踏开关1020的通信、与输入装置1009(例如，触摸屏显示器)的通信、以及与输出装置1047(例如，扬声器)的通信。UI处理器1090可与处理器1074和逻辑装置1066(例如，通过串行外围接口(SPI)总线)通信。尽管UI处理器1090可主要支持UI功能，然而在某些形式中，其也可与DSP处理器1074配合以减缓风险。例如，UI处理器1090可进行编程以监视用户输入和/或其它输入(例如，触摸屏输入、脚踏开关1020输入(图3)、温度传感器输入)并且可在检测到错误状态时使发生器1002的驱动输出无效。
在某些形式中，例如DSP处理器1074与UI处理器1090两者可确定并监视发生器1002的操作状态。对于DSP处理器1074，发生器1002的操作状态例如可指示DSP处理器1074实施的是哪些控制和/或诊断过程。对于UI处理器1090，发生器1002的操作状态可指示例如用户界面的哪些元素(例如，显示屏、声音)呈现给用户。相应的DSP处理器1074和UI处理器1090可独立地保持发生器1002的当前操作状态并识别和评估当前操作状态的可能转变。DSP处理器1074可用作此关系中的主体并确定何时会发生操作状态间的转变。UI处理器1090可注意到操作状态间的有效转变并可证实特定的转变是否适当。例如，当DSP处理器1074命令UI处理器1090转变至特定状态时，UI处理器1090可证实所要求的转变是有效的。如果UI处理器1090确定所要求的状态间转变是无效的，则UI处理器1090可使发生器1002进入无效模式。
非隔离台1054还可包括控制器1096用于监视输入装置1045(例如，用于接通和断开发生器1002的电容触摸传感器、电容触摸屏)。在某些形式中，控制器1096可包括至少一个处理器和/或与UI处理器1090通信的其它控制装置。在一种形式中，例如，控制器1096可包括处理器(例如，可从Atmel购得的Mega168 8位控制器)，所述处理器被构造成能够监视通过一个或多个电容触摸传感器提供的用户输入。在一种形式中，控制器1096可包括触摸屏控制器(例如可从Atmel购得的QT5480触摸屏控制器)，以控制和管理从电容触摸屏对触摸数据的采集。
在某些形式中，当发生器1002处于“功率关”状态时，控制器1096可继续接收操作功率(例如，通过来自发生器1002的功率源的线，诸如以下所述的功率源2011)。以此方式，控制器196可继续监视输入装置1045(例如，位于发生器1002的前面板上的电容触摸传感器)用于接通和断开发生器1002。当发生器1002处于功率关状态时，如果检测到用户“接通/断开”输入装置1045的启动，则控制器1096可唤醒电源(例如，启用电源2011的一个或多个DC/DC电压转换器2013的操作)。控制器1096可因此开始使发生器1002转变至“功率开”状态的序列。相反，当发生器1002处于功率开状态时，如果检测到“接通/断开”输入装置1045的启动，则控制器1096可开始使发生器1002转变至功率关状态的序列。在某些形式中，例如控制器1096可向处理器1090报告“接通/断开”输入装置1045的启动，所述处理器又会实施所需的过程序列以使发生器1002转变至功率关状态。在此类形式中，控制器196可能不具有在建立起功率开状态之后从发生器1002去除功率的独立能力。
在某些形式中，控制器1096可使发生器1002提供听觉或其它感观反馈，以警示用户功率开或功率关序列已开始。可在功率开或功率关序列开始时以及在与序列相关联的其它过程开始之前提供此类警示。
在某些形式中，隔离台1052可包括器械接口电路1098，以例如在外科装置的控制电路(例如，包括手持件开关的控制电路)与非隔离台1054的部件(诸如(例如)可编程逻辑装置1066、DSP处理器1074和/或UI处理器190)之间提供通信接口。器械接口电路1098可通过通信连接装置(诸如(例如)基于红外(IR)的通信连接装置)与非隔离台1054的部件交换信息，所述通信连接装置在台1052、1054之间保持合适程度的电隔离。例如，可使用由隔绝变压器提供功率的低跌落电压调节器为器械接口电路1098提供功率，所述隔绝变压器从非隔离台1054被驱动。
在一种形式中，器械接口电路198可包括与信号调节电路2002通信的逻辑装置2000(例如，逻辑电路、可编程逻辑电路、PGA、FPGA、PLD)。信号调节电路2002可被构造成能够从逻辑电路2000接收周期性信号(例如，2kHz方波)，以生成具有相同频率的双极性询问信号。例如，可使用由差分放大器馈送的双极性电流源生成询问信号。询问信号可被发送到外科装置控制电路(例如，通过使用将发生器102连接到外科装置的缆线中的导体对)并被监视，以确定控制电路的状态或配置。控制电路可包括多个开关、电阻器和/或二极管，以修改询问信号的一个或多个特性(例如，振幅、整流)，使得可基于所述一个或多个特性唯一地辨别控制电路的状态或配置。在一种形式中，例如信号调节电路2002可包括ADC用于产生由于询问信号通过控制电路而出现在控制电路输入中的电压信号的样本。随后，逻辑装置2000(或非隔离台1054的部件)可基于ADC样本来确定控制电路的状态或配置。
在一种形式中，器械接口电路1098可包括第一数据电路接口2004，以实现逻辑电路2000(或器械接口电路1098的其它元件)与设置于外科装置中的或换句话讲与外科装置相关联的第一数据电路之间的信息交换。在某些形式中，例如，第一数据电路2006(图2)可设置在一体化附接到外科装置手持件的缆线中，或设置在用于使特定的外科装置类型或模型与发生器1002交接的适配器中。数据电路2006可以任何合适的方式实施且可根据包括(例如)本文参照电路6006所述的任何合适的协议与发生器通信。在某些形式中，第一数据电路可包括非易失性存储装置，例如电可擦除的可编程的只读存储器(EEPROM)装置。在某些形式中并且再次参见图5，第一数据电路接口2004可与逻辑装置2000分开地实施并包括合适的电路(例如，分立逻辑装置、处理器)，以实现可编程逻辑装置2000与第一数据电路之间的通信。在其它形式中，第一数据电路接口2004可与逻辑装置2000形成一体。
在某些形式中，第一数据电路2006可存储与相关联的特定外科装置相关的信息。此类信息可包括例如型号、序列号、其中已使用外科装置的多个操作、和/或任何其它类型的信息。此信息可被器械接口电路1098(例如，通过逻辑装置2000)读取、被传输到非隔离台1054的部件(例如，逻辑装置1066、DSP处理器1074和/或UI处理器1090)，以通过输出装置1047呈现给用户和/或控制发生器1002的功能或操作。另外，任何类型的信息均可通过第一数据电路接口2004(例如，使用逻辑装置2000)被发送到第一数据电路2006以存储于其中。此类信息例如可包括其中使用外科装置的操作的更新数目和/或其使用的日期和/或时间。
如此前所述，外科器械可从手持件拆卸(例如，器械1024可从手持件1014拆卸)以促进器械可互换性和/或可任意处置性。在此类情形中，常规发生器的识别所使用特定器械构型和相应地优化控制和诊断过程的能力可受限。然而，从兼容性角度来看，通过对外科装置器械添加可读数据电路来解决此问题是有问题的。例如，设计外科装置来保持与缺少必备数据读取功能的发生器的向后兼容可能由于例如不同的信号方案、设计复杂性和成本而不切实际。本文所述器械的形式通过使用数据电路来解决这些问题，所述数据电路可经济地实施于现有外科器械中并具有最小的设计变化，以保持外科装置与电流发生器平台的兼容性。
另外，发生器1002的形式可实现与基于器械的数据电路的通信。例如，发生器1002可被构造成能够与包含在外科装置的器械(例如，器械1024)中的第二数据电路2007进行通信(图2)。在一些形式中，第二数据电路2007可以类似于本文所述的数据电路6006的方式实施。器械接口电路1098可包括用于实现此种通信的第二数据电路接口2010。在一种形式中，第二数据电路接口2010可包括三态数字接口，然而也可使用其它接口。在某些形式中，第二数据电路通常可为用于传输和/或接收数据的任何电路。在一种形式中，例如第二数据电路可存储与相关联的特定外科器械相关的信息。此类信息可包括例如型号、序列号、其中已使用外科器械的多个操作、和/或任何其它类型的信息。在一些形式中，第二数据电路2007可存储关于相关联的换能器1014、端部执行器1026或超声驱动系统的电性能和/或超声性能的信息。例如，第一数据电路2006可指示老化频率斜率，如本文所述。除此之外或另选地，任何类型的信息均可通过第二数据电路接口2010(例如，使用逻辑装置2000)被发送到第二数据电路以存储于其中。此类信息例如可包括其中使用外科器械的操作的更新数目和/或其使用的日期和/或时间。在某些形式中，第二数据电路可传输由一个或多个传感器(例如，基于器械的温度传感器)采集的数据。在某些形式中，第二数据电路可从发生器1002接收数据并基于所接收的数据向用户提供指示(例如，LED指示或其它可视指示)。
在某些形式中，第二数据电路和第二数据电路接口2010可被构造成能够使得可实现逻辑装置2000与第二数据电路之间的通信而无需提供用于此目的的附加导体(例如，用于将手持件连接到发生器1002的缆线的专用导体)。在一种形式中，例如可使用实施于现有缆线(诸如，用于将询问信号从信号调节电路2002传输至手持件中的控制电路的导体中的一个)上的单总线通信方案而使信息以通信方式到达和离开第二数据电路。以此方式，可最小化或减少原本可能必要的外科装置的设计变化或修改。此外，因为在共用物理通道上实施的不同类型的通信可为频带分离的，所以第二数据电路的存在对于不具有必备数据读取功能的发生器而言可为“隐形的”，因此能够实现外科装置器械的向后兼容性。
在某些形式中，隔离台1052可包括至少一个阻挡电容器2096-1，所述至少一个阻挡电容器2096-1连接到驱动信号输出件1060b以防止DC电流流向患者。例如，可要求信号阻挡电容器符合医疗规则或标准。尽管相对而言单电容器设计中很少出现错误，然而此类错误可造成不良后果。在一种形式中，可设置有与阻挡电容器2096-1串联的第二阻挡电容器2096-2，其中例如通过ADC 2098来监视从阻挡电容器2096-1与2096-2之间的点发生的电流泄漏，以对泄漏电流所感应的电压进行采样。这些样本例如可由逻辑电路2000接收。基于泄漏电流的变化(如图5的形式中的电压样本所指示)，发生器1002可确定阻挡电容器2096-1、2096-2中的至少一个何时出现故障。因此，图5的形式相对于具有单个故障点的单个电容器设计具有优势。
在某些形式中，非隔离台1054可包括电源2011用于在适当的电压和电流下输出DC功率。电源可包括例如400W的电源用于输出48VDC的系统电压。电源2011还可包括一个或多个DC/DC电压转换器2013，所述一个或多个DC/DC电压转换器用于接收电源的输出以在发生器1002的各种部件所需的电压和电流下产生DC输出。如以上结合控制器1096所述，当控制器1096检测到用户“接通/断开”输入装置1045的启动以启用DC/DC电压转换器2013的操作或唤醒DC/DC电压转换器2013时，DC/DC电压转换器2013中的一个或多个可从控制器1096接收输入。
根据对外科系统10(图1)的各种形式的操作细节的描述，可通常就采用包括输入装置1045和发生器1002的外科器械来切割和凝固组织的过程来进一步描述上述外科系统10的操作。尽管结合操作细节描述了具体过程，但应当理解，所述过程仅提供如何通过外科系统10实施本文所述的一般功能性的示例。此外，除非另外指明，否则给定的过程不一定按照本文所呈现的次序执行。如此前所述，可采用输入装置1045对外科装置1002、1006(图1)的输出(例如，阻抗、电流、电压、频率)进行编程。
图6示出了发生器1002的驱动系统32的一种形式，所述驱动系统产生用于驱动超声换能器的超声电信号，也称为驱动信号。驱动系统32是柔性的并且可生成处于期望频率和功率水平设定的超声电驱动信号416，以驱动超声换能器50。在各种形式中，发生器1002可包括若干独立的功能性元件，诸如模块和/或块。尽管可通过举例描述某些模块和/或区块，但可理解，可使用更多或更少数目的模块和/或区块，并仍落在所述形式的范围内。此外，尽管各种形式可按照模块和/或块的形式描述以有利于说明，然而这些模块和/或块可通过一个或多个硬件部件和/或软件部件和/或硬件部件和软件部件的组合加以实施，所述硬件部件为例如处理器、数字信号处理器(DSP)、可编程逻辑装置(PLD)、专用集成电路(ASIC)、电路、寄存器，所述软件部件为例如程序、子程序、逻辑。
在一种形式中，发生器1002的驱动系统32可包括以固件、软件、硬件或它们的任意组合实现的一个或多个嵌入式应用程序。发生器1002驱动系统32可包括各种可执行模块，例如软件、程序、数据、驱动器、应用程序接口(API)等。固件可存储在非易失性存储器(NVM)(诸如位屏蔽只读存储器(ROM)或闪速存储器)中。在各种具体实施中，将固件存储在ROM中可保护闪存存储器。NVM可包括其它类型的存储器，包括例如可编程ROM(PROM)、可擦除可编程ROM(EPROM)、电可擦除可编程ROM(EEPROM)或电池支持的随机存取存储器(RAM)(诸如动态RAM(DRAM)、双数据率DRAM(DDRAM)和/或同步DRAM(SDRAM))。
在一种形式中，发生器1002驱动系统32包括实施为处理器400的硬件部件，所述处理器用于执行监视超声外科器械1004(图1)的各种可测量特性的程序指令并且产生用于驱动切割和/或凝固操作模式下的超声换能器的阶跃函数输出信号。本领域的技术人员应当理解，发生器1002和驱动系统32可包括更多或更少的部件，并且为了简明和清楚起见，本文仅描述了简化版本的发生器1002和驱动系统32。在各种形式中，如在前所述，硬件部件可作为DSP、PLD、ASIC、电路和/或寄存器实施。在一种形式中，处理器400可被构造成能够用于存储和执行计算机软件程序指令，以产生用于驱动超声外科器械1004的各种部件(诸如换能器、端部执行器和/或刀)的阶跃函数输出信号。
在一种形式中，在一个或多个软件程序调度程序的控制下，处理器400执行根据所述形式的方法以产生阶跃函数，所述阶跃函数由包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成。驱动信号的分段波形可通过形成多个时间间隔的常值函数的分段线性组合而产生，所述常值函数通过发生器30驱动信号例如输出电流(I)、电压(V)和/或频率(f)的阶跃来产生。时间间隔或周期(T)可为预定的(例如，固定的和/或通过用户编程的)或者可为可变的。可变时间间隔可通过以下方法限定：将驱动信号设定为第一值，以及在监视的特性中检测到变化之前，将驱动信号保持为该值。所监视特性的示例可包括例如换能器阻抗、组织阻抗、组织加热、组织横切、组织凝固等等。发生器30所生成的超声驱动信号包括但不限于能够以各种振动模式激发超声换能器50的超声驱动信号，所述振动模式例如为主要纵向模式及其谐波以及弯曲和扭转振动模式。
在一种形式中，可执行模块包括存储在存储器中的一个或多个阶跃函数算法402，当执行这些算法时，使处理器400产生由包括电流(I)、电压(V)和/或针对各种时间间隔或周期(T)的频率(f)的驱动信号的分段波形形成的阶跃函数。驱动信号的分段波形可通过形成两个或更多个时间间隔的常值函数的分段线性组合而产生，所述常值函数通过发生器1002的输出驱动电流(I)、电压(V)、和/或频率(f)的阶跃来产生。根据所述一个或多个阶跃输出算法402，可针对时间的预定固定时间间隔或周期(T)或时间的可变时间间隔或周期产生驱动信号。在处理器400的控制下，发生器1002针对预定周期(T)或在预定条件被检测到之前以特定分辨率向上或向下阶跃(例如，递增或递减)电流(I)、电压(V)和/或频率(f)，所述预定条件例如为所监视特性(例如，换能器阻抗、组织阻抗)的改变。在编程的递增或递减中，所述阶跃可变化。如果需要其它阶跃，则发生器1002可适应性地基于测量到的系统特性增加或减少阶跃。
在操作中，用户可利用位于发生器1002的控制台的前面板上的输入装置406对发生器1002的操作进行编程。输入装置406可包括产生信号408的任何合适装置，所述信号可被施加到处理器400以控制发生器1002的操作。在各种形式中，输入装置406包括钮、开关、指轮、键盘、小键盘、触摸屏监视器、指点装置，所述输入装置远程连接到通用或专用计算机。在其它形式中，输入装置406可包括合适的用户界面。因此，通过输入装置406，用户可设定或编程电流(I)、电压(V)、频率(f)和/或周期(T)用于对发生器30的阶跃函数输出进行编程。随后处理器400通过将在线信号410发送到输出指示器412来显示选定的功率水平。
在各种形式中，输出指示器412可为外科医生提供视觉、听觉和/或触觉反馈，以指示外科规程的状态，诸如(例如)基于测量的超声外科器械1004的特性(例如换能器阻抗、组织阻抗)或随后描述的其它测量来确定组织切割和凝固何时完成。以举例而非限制的方式，视觉反馈包括任何类型的视觉指示装置，其包括白炽灯或发光二极管(LED)、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例而非限制的方式，听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、经计算机处理的语言、通过语音/语言平台与计算机进行交互的语音用户界面(VUI)。以举例而非限制的方式，触觉反馈包括通过器械外壳柄部组件提供的任何类型的振动反馈。
在一种形式中，处理器400可被构造成能够或被编程用于生成数字电流信号414和数字频率信号418。这些信号414、418被施加到直接数字合成器(DDS)电路420，以调节输出到换能器的电流输出信号416的振幅和频率(f)。DDS电路420的输出被施加到放大器422，所述放大器的输出被施加到变压器424。变压器424的输出为施加到超声换能器的信号416，所述超声换能器通过波导联接到刀。
在一种形式中，发生器1002包括一个或多个测量模块或部件，所述一个或多个测量模块或部件可被构造成能够监视超声器械1004(图1)的可测量特性。在所示形式中，可采用处理器400来监视和计算系统特性。如图所示，处理器400通过监视供应到换能器50的电流和施加到换能器的电压来测量换能器的阻抗Z。在一种形式中，采用电流感测电路426来感测流经换能器的电流，并且采用电压感测电路428来感测施加到换能器的输出电压。这些信号可通过模拟多路复用器430电路或开关电路结构被施加到模数转换器432(ADC)。模拟多路复用器430将合适的模拟信号沿特定路线发送到模数转换器432用于转换。在其它形式中，可采用多个模数转换器432来替代多路复用器430电路用于每一个测量的特性。处理器400接收ADC 432的数字输出433并且基于测得的电流和电压值计算换能器阻抗Z。处理器400调节输出驱动信号416，使得所述驱动信号可产生期望的功率与负载的曲线关系。根据编程的阶跃函数算法402，处理器400可响应于换能器阻抗Z以任何合适的增量或减量使驱动信号416(例如，电流或频率)阶跃。
根据所描述的外科系统10的各种形式的操作细节，可就采用包括输入装置1045和参照图6描述的换能器阻抗测量能力的外科器械来切割和凝固血管的过程来进一步描述上述外科系统10的操作。尽管结合操作细节描述了具体过程，但应当理解，所述过程仅提供如何通过外科系统10实施本文所述的一般功能性的示例。此外，除非另外指明，否则给定的过程不一定按照本文所呈现的次序执行。
在各种形式中，通过如图6和图7所示的输出指示器412提供反馈。输出指示器412在以下应用中特别有用：其中被端部执行器操纵的组织脱离用户的视野并且用户不能看见组织中何时发生状态变化。输出指示器412将已发生的组织状态变化发送给用户。如此前所论，输出指示器412可被构造成能够向用户提供各种类型的反馈，包括但不限于视觉、听觉和/或触觉反馈，以向用户(例如外科医生、临床医生)指示组织已发生组织的状态或条件变化。以举例而非限制的方式，如此前所述，视觉反馈包括任何类型的视觉指示装置，包括白炽灯或LED、图形用户界面、显示器、模拟指示器、数字指示器、柱状图显示器、数字字母显示器。以举例而非限制的方式，听觉反馈包括任何类型的蜂鸣器、计算机产生的音调、经计算机处理的语言、通过语音/语言平台与计算机进行交互的VUI。以举例而非限制的方式，触觉反馈包括通过器械外壳柄部组件提供的任何类型的振动反馈。组织状态的变化可基于此前所述的换能器和组织阻抗测量，或者基于电压、电流和频率测量来确定。
在一种形式中，包括计算机可读指令的各种可执行模块(例如，算法)可由发生器1002的处理器400(图6、7)部分来执行。在各种形式中，相对于算法描述的操作可被实施为一个或多个软件部件，例如，程序、子程序、逻辑；一个或多个硬件部件，例如，处理器、DSP、PLD、ASIC、电路、寄存器；和/或软件与硬件的组合。在一种形式中，用以执行算法的可执行指令可存储在存储器中。当被执行时，指令导致处理器400确定组织状态的变化并且通过输出指示器412将反馈提供给用户。根据这种可执行指令，处理器400监视并评估可从发生器1002获得的电压、电流和/或频率信号样本，并根据对这些信号样本的评估来确定组织状态是否已发生变化。如以下的进一步描述，组织状态的变化可基于超声器械的类型和激发所述器械的功率水平来确定。响应所述反馈，可通过用户控制或可自动或半自动地控制超声外科器械1004的操作模式。
本文所述的外科器械还可包括特征部以允许用户诸如临床医生基于正被执行的外科规程的类型和正被外科器械的端部执行器治疗的组织的类型来从多个外科模式中选择。每个外科模式对应于算法，所述算法用于控制从发生器诸如发生器1002传送到外科器械的端部执行器的功率输出。如图8所示，外科器械20可包括允许临床医生在多个外科模式之间选择的选择器开关22。
各种算法可用于允许多个外科模式的选择。在一种形式中，外科模式可取决于正被端部执行器治疗的组织。外科模式也可根据发生器正传送的能量类型而改变。发生器可以在组织正被端部执行器治疗时基于组织的变化来传送自适应的能量。在一种形式中，发生器可监视组织的温度并且调节输出的频率，以调控组织中的温度变化。在一种形式中，外科器械可包括用于禁用自适应能量的开关，使得用户可控制来自发生器的自适应能量的传送，而不管所选择的外科模式。例如，一个外科模式可被选择用于切割无血管组织并且可包括来自发生器的最优化用于横切速度的高功率输出。另一个外科模式可被选择用于凝固组织或血管，并且可包括来自发生器的最优化用于血管止血的低功率输出。另一个外科模式可被选择用于实体器官的治疗并且可包括来自发生器的最优化用于实体器官止血的较低功率水平输出而非自适应能量。
尽管图8示出了选择器开关以控制外科模式的选择，但可采用各种其它技术以允许用户选择外科模式。在一种形式中，可使用外科器械上的软件。例如，外科器械可包括显示器，使得可利用显示器选择多个可用的外科模式。相似地，在另一种形式中，发生器诸如发生器1002可包括软件和显示器，使得可利用发生器上的显示器选择多个可用的外科模式。在另一种形式中，软件可被包括在发生器或外科器械中，以允许外科模式的话音启动。在另一种形式中，可使用外部通信装置与发生器或外科器械通信以允许外科模式的选择。例如，任何类型的个人通信装置可利用多种技术与发生器或外科器械通信，所述技术包括但不限于短射程无线电、WiFi或蓝牙技术。个人通信装置可包括具有多个外科模式的软件，使得用户可利用个人通信装置选择一个或多个期望的外科模式。
图9示出了选择外科模式的一种形式的逻辑流程图30，所述外科模式对应于可在发生器的一种形式中实施的组织算法。现在参见图9所示的逻辑流程图30和图1的外科系统10，用户利用选择器开关(例如图8的选择器开关22)选择对应于用于控制发生器1002的算法的外科模式(步骤32)。使用所选择的算法控制来自发生器1002的功率输出(步骤34)。将来自发生器1002的功率输出传送到外科器械的端部执行器(步骤36)，使得端部执行器可用于治疗定位在端部执行器内的组织。用户确定是否需要另外的外科模式以继续正在执行的外科规程(步骤38)。如果不需要另外的外科模式，则可停用发生器1002(步骤40)。如果需要另外的外科模式以继续规程，则用户可选择多个外科模式中的另一个以继续和完成规程(步骤42)。可连续地选择任何数量的外科规程，直到完成外科规程。
不同的临床医生通常具有用于使用如本文所述的超声外科器械和系统的不同技术。在一些形式中，可采用可由临床医生定制和修改的算法。存在可由用户定制的外科模式算法的各种方面。在一种形式中，可选择来自发生器的功率输出和/或任何功率下降的定时。在一种形式中，可选择来自外科系统10的任何部件的反馈(包括听觉反馈的任何监视器的功能)，使得用户可定制外科规程期间所接收的反馈。
用户还可以多种方式与外科系统通信以允许使用定制的外科模式。在一种形式中，发生器可包括插座用于接收在其上具有定制的外科模式的输入装置。例如，输入装置可呈RFID刷钥匙、USB装置的形式、或者数字密码的一些形式。输入装置也可呈个人通信装置的形式，所述个人通信装置允许用户在其上创建和修改定制的外科模式并且与发生器有线地和无线地通信。输入装置可将定制的外科模式发送到发生器，使得当外科模式被选择用于外科规程时，发生器将传送对应于针对所述特定用户定制的设置的输出。
图10示出了定制外科模式的一种形式的逻辑流程图50，所述外科模式对应于可在发生器的一种形式中实施的组织算法。现在参见图10所示的逻辑流程图50和图1的外科系统10，用户选择对应于用于控制发生器1002的算法的可供定制的外科模式(步骤52)。通过选择来自发生器1002的期望功率输出来定制所选择的算法(步骤54)。例如，用户可选择由发生器在所述外科模式的使用期间传送的最小功率输出和/或最大功率输出(步骤54)。通过选择所述外科模式的使用期间来自发生器的功率输出的功率下降和功率下降的定时来定制所选择的算法(步骤56)。利用本文所述的技术中的任一个将定制的算法发送到发生器100(步骤58)。应当理解，来自发生器1002的功率输出的任何方面可由用户定制和修改以创建可在外科规程期间使用的定制算法。
另外可有利的是采用技术以延长端部执行器上的能量垫的寿命。例如，垫寿命可通过等待端部执行器在组织周围闭合(在能量的两者被传送到垫时且组织在其间未被压缩的前提下)来改进，并且摩擦可减小端部执行器的使用寿命和次数。在各种形式中，此问题以及其它问题可通过将外科器械构造成具有闭合开关来加以解决，所述闭合开关指示端部执行器何时完全闭合且在其间具有组织。发生器可被构造成能够避免启动外科器械，直到或除非闭合开关指示夹持臂完全闭合。闭合开关可具有各种形式，包括被定位在外科装置的柄部中。闭合开关可与发生器诸如发生器1002电连通。在一种形式中，发生器被编程以不启动外科器械，除非开关指示端部执行器被闭合。例如，如果发生器从本文所述开关中的一个或多个接收到启动请求，则其可仅在闭合开关被启动以指示端部执行器被闭合时才对启动请求作出响应。这允许端部执行器的位置和闭合开关的状态被用作算法的输入，所述算法用于控制发生器的功率输出。
在另一种形式中，发生器被编程以不启动任何类型的自适应能量，除非开关指示端部执行器被闭合。例如，如果发生器从本文所述开关中的一个或多个接收到启动请求，则其可仅在闭合开关被启动以指示端部执行器被闭合时才对自适应能量的启动请求作出响应。如果闭合开关未被启动，由此指示端部执行器为打开的，则发生器可通过传送可用于某些外科手术情形(例如回切或横切实体器官)中的非自适应能量来作出响应。如果闭合开关被启动，由此指示端部执行器为闭合的，则发生器可通过传送自适应能量来作出响应，所述自适应能量将被启动用于所选择外科模式的整个启动周期，并且可用于大部分外科手术情形，例如端部执行器针对组织或血管的任何正常用途。
如图2所示，外科器械可包括用于使端部执行器1026运动的触发器。在一种形式中，触发器使端部执行器在其中端部执行器为打开的第一位置与其中端部执行器闭合在组织上以进行治疗的第二位置之间运动。当端部执行器被闭合时，发生器可将自适应能量传送到端部执行器以治疗组织。
图11示出了用于选择对应于组织算法的外科模式的逻辑流程图60，所述组织算法将外科器械的端部执行器的位置用作算法输入。现在参见图11所示的逻辑流程图60和图1的外科系统10，用户选择对应于用于控制发生器1002的算法的外科模式(步骤62)。使用所选择的算法控制来自发生器的功率输出(步骤64)。在将功率传送到端部执行器之前，检查外科器械上的闭合开关的位置(步骤66)。例如，将用于控制端部执行器的触发器的位置用作算法的输入。当闭合开关或触发器处于第一位置使得开关和端部执行器打开时，发生器的自适应能量模式被禁用使得自适应能量不能被传送到端部执行器(步骤68)。当闭合开关或触发器处于第二位置使得开关和端部执行器闭合在待治疗的组织上时，发生器的自适应能量模式被启用使得自适应能量能够被传送到端部执行器(步骤70)。
在一种形式中，可以测量端部执行器的位置以基于端部执行器相对于组织的位置来更精确地控制来自发生器的功率输出。除了端部执行器围绕组织打开或闭合之外，端部执行器还可围绕组织部分地闭合。可使用端部执行器的部分闭合的角度修改来自发生器的功率输出，而非仅启动或停用从其传送的自适应能量。图12示出了用于选择对应于组织算法的外科模式的逻辑流程图80的另一种形式，所述组织算法将外科器械的端部执行器的位置用作算法输入。现在参见图12所示的逻辑流程图80和图1的外科系统10，用户选择对应于用于控制发生器1002的算法的外科模式(步骤82)。使用所选择的算法控制来自发生器的功率输出(步骤84)。在将功率传送到端部执行器之前，检查外科器械上的闭合开关的位置(步骤86)。例如，将用于控制端部执行器的触发器的位置用作算法的输入。当闭合开关或触发器处于第一位置使得开关和端部执行器打开时，发生器的自适应能量模式被禁用使得自适应能量不能被传送到端部执行器(步骤88)。当闭合开关或触发器处于第二位置使得开关和端部执行器闭合在待治疗的组织上时，发生器的自适应能量模式被启用使得自适应能量能够被传送到端部执行器(步骤92)。利用端部执行器的闭合角度的测量结果来调整从发生器1002传送的能量(步骤90)。在一种形式中，能量的频率斜率可根据端部执行器的闭合角度而改变。当端部执行器施加到组织上的压力增加并且闭合角度减小时，可根据组织的期望效果来改变功率用于所选择的外科模式。例如，可在闭合角度减小时减少能量以保持恒定的组织切割。
另外当端部执行器闭合在组织上时，可通过考虑端部执行器的启动次数来改善端部执行器的垫寿命。因此，从发生器传送的自适应能量可随着端部执行器的闭合启动次数而改变。在一种形式中，所传送的自适应能量可随着端部执行器的闭合启动次数增加而更接近所选择的外科模式的启动周期开始时的能量。例如，计数器可用于跟踪端部执行器的闭合启动次数并且可用作算法的输入用于控制从发生器传送到端部执行器的能量。因此，传送的自适应能量可基于端部执行器上的能量垫的启动次数而改变。
图13示出了用于选择对应于组织算法的外科模式的逻辑流程图100的另一种形式，所述组织算法将外科器械的端部执行器的位置用作算法输入。现在参见图13所示的逻辑流程图100和图1的外科系统10，用户选择对应于用于控制发生器1002的算法的外科模式(步骤102)。使用所选择的算法控制来自发生器的功率输出(步骤104)。在将功率传送到端部执行器之前，检查外科器械上的闭合开关的位置(步骤106)。例如，将用于控制端部执行器的触发器的位置用作算法的输入。当闭合开关或触发器处于第一位置使得开关和端部执行器打开时，发生器的自适应能量模式被禁用使得自适应能量不能被传送到端部执行器(步骤108)。当闭合开关或触发器处于第二位置使得开关和端部执行器闭合在待治疗的组织上时，测量端部执行器的闭合启动次数的计数器增加(步骤110)。可以将计数器与例如阈值进行比较(步骤112)，所述阈值可向用户通知端部执行器上的能量垫因已经进行多次闭合启动时而应被替换。启用发生器的自适应能量模式使得可将自适应能量传送到端部执行器(步骤114)。传送的自适应能量将受计数器的影响，因为计数器将被用作控制由发生器传送的能量的算法的输入。
如上所述，存在可用于控制来自发生器的输出的多个外科模式。下表1示出了用于控制来自发生器的功率输出的示例性外科模式和算法。
Figure BDA0001529691430000251
表1
虽然上文说明已列举了各种细节，但应当理解，用于医疗装置的串行通信协议的各个方面可在没有这些具体细节的情况下实施。例如，为简洁和清楚起见，以框图的形式示出了选择的方面，而不是详细地示出。本文提供的详细描述的某些部分可以呈现为对存储在计算机存储器中的数据进行操作的指令。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步骤的自相容序列，其中“步骤”是指物理量的操纵，物理量可以(但不一定)采用能被存储、转移、组合、比较和以其它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的方便的标签。
除非上述讨论中另外明确指明，否则可以理解的是，在上述描述中，使用术语如“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设备的动作和处理，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它此类信息存储、传输或显示设备内的物理量的其它数据。
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(an 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。
一些方面可使用表达“联接”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直接物理接触或电接触。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。
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(an 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。
虽然本文描述了各种形式，但可以实现那些形式的多种修改形式、变型形式、替代形式、变化形式和等同形式，这些形式是本领域技术人员将会想到的。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随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。
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、固件或它们的任何组合单独和/或共同实施的本文所述的多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设备的电子电路(如，至少部分地实施本文所述的方法和/或设备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/或设备的由计算机程序配置的微处理器)、形成存储器设备(如，形成随机存取存储器)的电子电路，和/或形成通信设备(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/或方法的各种形式。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)或其它集成格式来实施。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)。
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它公开材料均在不与其相抵触的程度上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。
本领域技术人员将会认识到，本文所述的组成部分(例如，操作)、装置、对象和它们随附的论述是为了概念清楚起见而用作示例，并且可以设想多种构型修改形式。因此，如本文所用，阐述的具体示例和随附的论述旨在代表它们更一般的类别。通常，任何具体示例的使用旨在代表其类别，并且具体组成部分(例如，操作)、装置和对象的未纳入部分不应采取限制。
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。
本文所述的主题有时阐述了包含在其它不同部件中的不同部件或与其它不同部件连接的不同部件。应当理解，这样描述的结构仅是示例性的，并且事实上可以实现获得相同功能性的多种其它结构。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组件也可被视为彼此“以可操作的方式连接”或“以可操作的方式联接”，以获得所需的功能性，并且能够如此相关联的任何两个组件都可被视为彼此“以可操作的方式联接”，以获得所需的功能性。以可操作的方式联接的具体示例包括但不限于可物理匹配的和/或物理交互组件，和/或无线交互式，和/或无线交互式组件，和/或逻辑交互式，和/或逻辑交互式组件。
在一些情况下，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”、“适合/适于”、“能够”、“适应/适合”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文所述的本发明主题的特定方面，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作出改变和变型，并且如在本文所述的主题的真实实质和范围内，其更广泛的方面并因此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，在没有其它修饰语的情况下，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。
对于所附的权利要求，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。
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。
虽然本文描述了各种形式，但可以实现那些形式的多种修改形式、变型形式、替代形式、变化形式和等同形式，这些形式是本领域技术人员将会想到的。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随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。
概括地说，已经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。
实施例
在一个总体方面，实现所描述的形式的原理的外科器械组件被构造成能够能够允许在外科规程过程中选择性地解剖、切割、凝固和夹持组织。发生器可生成可针对第一组逻辑条件监视的至少一个电信号。当所述第一组逻辑条件得到满足时，所述发生器的第一响应可被触发。
在某些形式中，外科器械的超声阻抗受到监视。当所述外科器械的所述超声阻抗超过阈值阻抗时，可存储所述至少一个电信号的谐振频率作为基线频率。此外，所述发生器的所述第一响应可在所述第一组逻辑条件得到满足或所述至少一个电信号的所述谐振频率与所述基线频率相差基线偏差阈值时被触发。
在某些形式中，所述外科器械的端部执行器处的负载事件可受到监视。所述发生器的所述第一响应可在所述第一组逻辑条件得到满足并且检测到负载事件时被触发。
根据一种一般形式，提供一种用于超声外科器械的开关组件，所述开关组件包括被构造成能够支撑在一只手中的柄部外壳。在至少一种形式中，所述开关组件包括第一开关布置，所述第一开关布置被操作地支撑在所述柄部外壳的向前部分上并且可相对于至少一个第一开关触点选择性地运动。所述开关组件还包括第二开关布置，所述第二开关布置可包括右开关钮和左开关钮中的至少一者。所述右开关钮可被活动地支撑在所述柄部外壳的右侧上并且可相对于至少一个右开关触点选择性地运动，所述至少一个右开关触点由所述柄部外壳支撑。所述左开关钮可被活动地支撑在所述柄部外壳的左侧上并且可相对于至少一个左开关触点选择性地运动，所述至少一个左开关触点由所述柄部外壳支撑。所述第一开关布置和所述第二开关布置可被构造成能够由支撑所述柄部外壳的单只手选择性地操作。
根据至少一个其它一般形式，提供一种超声外科器械。在至少一种形式中，所述超声外科器械包括发生器和柄部组件，所述发生器用于生成超声信号，所述柄部组件包括柄部外壳，所述柄部外壳被构造成能够操作地支撑在一只手中。所述器械还可包括开关组件，所述开关组件包括第一开关布置，所述第一开关布置被操作地支撑在所述柄部外壳的向前部分上并且可相对于至少一个第一开关触点选择性地运动，所述至少一个第一开关触点与所述发生器连通。所述开关组件还可包括第二开关布置，所述第二开关布置可包括右开关钮和左开关钮中的至少一者。所述右开关钮可被活动地支撑在所述柄部外壳的右侧上并且可相对于至少一个右开关触点选择性地运动，所述至少一个右开关触点由所述柄部外壳支撑。所述至少一个右开关触点可与所述发生器连通。所述左开关钮可被活动地支撑在所述柄部外壳的左侧上并且可相对于至少一个左开关触点选择性地运动，所述至少一个左开关触点由所述柄部外壳支撑并且可操作地与所述发生器连通。所述第一开关布置和所述第二开关布置可被构造成能够由支撑所述柄部外壳的单只手选择性地操作。
根据另一个一般形式，提供一种用于超声外科器械的开关组件，所述开关组件包括被构造成能够支撑在一只手中的柄部外壳。在至少一种形式中，所述开关组件包括钮组件，所述钮组件由所述柄部外壳活动地支撑，以相对于右开关触点、中心开关触点和左开关触点选择性轴向行进和枢转行进，使得所述钮组件沿第一方向的轴向运动使所述钮组件致动所述中心开关触点且所述钮组件沿第一枢转方向的枢转运动使所述钮组件致动所述左开关触点并且所述钮组件沿第二枢转方向的枢转运动使所述钮组件致动所述右开关触点。
根据各种形式，所述连接器模块可为模块式部件，其可作为附件与所述超声外科器械或其部件一起提供，但不附接至所述超声外科器械或其部件，或者可用于修复、更换或改造超声外科器械。然而，在某些形式中，所述连接器模块可与所述柄部组件或所述超声换能器相关联。在一种形式中，所述连接器模块可包括可容易由用户移除和/或更换的组件。所述连接器模块还可包括允许用户(例如)移除和/或更换旋转联接器、开关导体或连杆的可移除特征部。因此，在某些形式中，一个或多个连接器模块可被包含在套件中。所述套件可包括被构造用于适于与一个或多个超声换能器或手持件一起使用的各种旋转联接器。所述套件可包括连接器模块、旋转联接器或壳体，所述壳体包括可能需要一个、两个或更多个导电路径的各种配置的用户界面。
在一个方面，本公开涉及一种超声外科器械。所述超声器械可包括：端部执行器；波导，所述波导从所述端部执行器沿纵向轴朝近侧延伸；和连接器模块，所述连接器模块用于接纳超声手持件。所述连接器模块可包括：壳体，所述壳体限定沿所述纵向轴延伸的心轴；联接器，所述联接器定位在所述心轴上并且可相对于所述壳体旋转；第一导体，所述第一导体机械联接到所述壳体并且至少部分地围绕所述纵向轴延伸；和第一连杆，所述第一连杆可在第一位置与第二位置之间相对于所述第一导体围绕所述纵向轴旋转。所述第一连杆可包括第一触点和第二触点，所述第一触点被定位成当所述第一连杆处于所述第一位置和所述第二位置时电接触所述第一导体，所述第二触点电联接到所述第一触点并且被定位成当所述第一连杆处于所述第一位置和所述第二位置时电接触所述超声手持件。
在一个方面，所述第一导体和所述第二导体各自包括导电引线，所述导电引线被构造成能够电联接到用户界面，所述用户界面被构造用于从用户接收功率控制信号。所述超声手持件可适于电联接到发生器并且在由所述连接器模块接纳时旋转地联接到所述第一连杆和所述第二连杆。所述连接器模块可被构造成能够在所述第一连杆和所述第二连杆处于相应的第一位置和第二位置时通过所述超声手持件电联接所述用户界面电路和所述发生器。在一个方面，所述用户界面包括操作地联接到柄部组件的切换开关且所述连接器模块固定到所述柄部组件。所述超声手持件可在由所述连接器模块接纳时相对于所述柄部组件旋转。在一个方面，所述壳体使所述第一导体和所述第二导体相对于彼此电隔离。
本文所述主题的各个方面涉及一种设备，所述设备包括被构造成能够通过一对电导体传输信号作为串行协议的电路。所述串行协议可定义为通过至少一个传输帧分布的一系列脉冲。通过调制所述传输帧中的至少一个脉冲的振幅以代表两个第一逻辑状态中的一者并调制所述脉冲的宽度以代表两个第二逻辑状态中的一者同时对所述脉冲进行编码。
本文所述主题的各个方面涉及一种器械，所述器械包括被构造成能够通过一对电导体传输信号作为串行协议的电路。所述串行协议可定义为通过至少一个传输帧分布的一系列脉冲。可通过调制所述传输帧中的至少一个脉冲的振幅以代表两个第一逻辑状态中的一者并调制所述脉冲的宽度以代表两个第二逻辑状态中的一者同时对所述脉冲进行编码。所述器械还可包括联接到电路的输出的输出装置；和联接到电路的输入的输入装置。
本文所述主题的各个方面涉及一种发生器，所述发生器包括调节电路，所述调节电路被构造成能够通过双线界面与器械通信。所述发生器可包括控制电路，所述控制电路被构造成能够通过一对电导体传输信号作为串行协议。所述串行协议可定义为通过至少一个传输帧分布的一系列脉冲。通过调制所述传输帧中的至少一个脉冲的振幅以代表两个第一逻辑状态中的一者并调制所述脉冲的宽度以代表两个第二逻辑状态中的一者同时对所述脉冲进行编码。所述发生器还可包括被构造成能够驱动所述器械的能量电路。
各种方面涉及驱动联接到超声外科器械的超声驱动系统的端部执行器的方法。可接收触发信号。响应于所述触发信号，可向所述超声驱动系统提供第一驱动信号以在第一功率水平下驱动所述端部执行器。可使所述第一驱动信号保持达第一周期。在所述第一周期结束时，可向所述超声驱动系统提供第二驱动信号以在小于所述第一功率水平的第二功率水平下驱动所述端部执行器。
在另一方面，在接收到触发信号之后，外科系统生成指示所述超声外科器械启动的反馈同时使所述超声器械保持处于停用状态。在所述阈值时间周期结束时，通过向所述超声驱动系统提供驱动信号以驱动所述端部执行器来启动所述超声外科器械。
在另一方面，通过生成提供至所述超声驱动系统的驱动信号以驱动所述端部执行器来启动所述超声外科器械。可对多变量模型施加多个输入变量以生成多变量模型输出，其中所述多变量模型输出对应于所述超声器械对组织的作用。所述多个输入变量可包括描述所述驱动信号的至少一个变量和描述所述超声外科器械的性能的至少一个变量。当所述多变量模型输出达到阈值时，可生成指示所述超声外科器械和受到所述超声外科器械作用的组织中的至少一者的对应状态的反馈。
在另一方面，响应于触发信号，向所述超声驱动系统提供第一功率水平下的第一驱动信号以驱动所述端部执行器。使所述第一驱动信号在所述第一水平下保持达第一周期。向所述超声驱动系统提供第二驱动信号以在小于所述第一功率水平的第二功率水平下驱动所述端部执行器。可对多变量模型施加多个输入变量以生成多变量模型输出。所述多变量模型输出可对应于所述超声器械对组织的作用，且所述多个变量可包括描述所述驱动信号的至少一个变量和描述所述超声外科器械的性能的至少一个变量。在所述多变量模型输出超过阈值达阈值时间周期之后，可触发第一响应。
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。在不脱离本发明的范围的条件下，本领域的技术人员可以进行许多变型、更改和替代。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具。因此，旨在使所描述的形式仅受所附权利要求的范围的限制。
在整篇说明书中引用的“各种形式(various forms)”、“一些形式(some forms)”、“一种形式(one form)”或“一形式(an form)”是指结合所述形式描述的特定特征、结构或特性包括在至少一种形式中。因此，出现在整篇说明书中的不同地方的短语“在各种形式中”、“在一些形式中”、“在一种形式中”或“在一形式中”不一定都是指同一形式。此外，具体特征、结构或特性可在一个或多个形式中以任何合适的方式结合。因此，结合一种形式示出或描述的具体特征、结构或特性可没有限制地全部或部分地与一个或多个其它形式的特征、结构或特性结合。

Claims (18)

1.一种用于组织的解剖和凝固的设备，包括：
具有端部执行器的外科器械，所述端部执行器被构造成能够在其远侧端部处解剖和密封组织，所述外科器械包括在所述外科器械上的选择器开关，所述选择器开关具有多个外科模式；
发生器，所述发生器电联接到所述外科器械并且被构造成能够在启动周期期间将功率输出传送到所述端部执行器；
其中所述多个外科模式包括第一外科模式和第二外科模式，其中所述选择器开关的第一外科模式对应于用于控制从所述发生器传送到所述端部执行器的功率输出的第一算法，其中所述选择器开关的第二外科模式对应于用于控制从所述发生器传送到所述端部执行器的功率输出的第二算法，并且其中所述第一算法和所述第二算法是不同的，其中所述外科器械包括被构造成能够在第一位置和第二位置之间运动的闭合开关，其中所述第一算法和所述第二算法中的一个或多个包括用于在所述闭合开关定位在所述第二位置时对所述端部执行器的启动次数进行计数的阈值计数器，使得来自所述发生器的所述功率输出基于所述启动次数而改变，并且其中被传送的所述功率输出随着所述启动次数增加而更接近所述启动周期开始时的功率输出。
2.根据权利要求1所述的设备，其中所述功率输出包括最大功率输出和最小功率输出，其中所述发生器的所述最大功率输出和所述最小功率输出由用户控制。
3.根据权利要求1所述的设备，其中所述第一算法和所述第二算法中的每个算法能够允许用户修改每个外科模式期间的所述功率输出下降的定时。
4.根据权利要求1所述的设备，其中所述第一算法和所述第二算法中的对应于所述多个外科模式中的每个外科模式的每个算法能够被用户修改以允许所述多个外科模式中的每个外科模式的定制。
5.根据权利要求1所述的设备，其中当所述闭合开关在所述第一位置时，所述端部执行器为打开的以允许组织被定位在所述端部执行器内，并且当所述闭合开关在所述第二位置时，所述端部执行器为闭合的使得组织被所述端部执行器保持。
6.根据权利要求5所述的设备，其中所述发生器被构造成能够在所述端部执行器闭合时将所述功率输出传送到所述端部执行器。
7.根据权利要求5所述的设备，其中所述多个外科模式包括自适应功率模式，并且其中所述发生器的所述自适应功率模式被启用使得当所述端部执行器闭合在所述组织上时，能够将自适应功率从所述发生器传送到所述端部执行器。
8.根据权利要求5所述的设备，其中当所述闭合开关被定位在所述第一位置和所述第二位置之间时所述端部执行器的闭合角度能够被检测，所述端部执行器的闭合角度用于调整从所述发生器传送到所述端部执行器的所述功率输出。
9.一种用于组织的解剖和凝固的设备，包括：
具有端部执行器的外科器械，所述端部执行器被构造成能够在其远侧端部处解剖和密封组织，所述外科器械包括在所述外科器械上的选择器开关，所述选择器开关具有多个外科模式；
发生器，所述发生器电联接到所述外科器械并且被构造成能够将功率输出传送到所述端部执行器；
其中所述选择器开关的所述多个外科模式中的每个外科模式对应于用于控制从所述发生器传送到所述端部执行器的功率输出的算法，其中所述外科器械包括被构造成能够在第一位置和第二位置之间运动的闭合开关，当所述闭合开关在所述第一位置时所述端部执行器是打开的以允许所述组织定位在所述端部执行器内，当所述闭合开关在所述第二位置时所述端部执行器是闭合的使得所述组织被所述端部执行器保持，并且其中对应于所述多个外科模式的所述算法中的一个或多个包括阈值计数器，所述阈值计数器用于在所述闭合开关处于所述第二位置时对所述端部执行器的启动次数进行计数，使得来自所述发生器的所述功率输出随着所述启动次数的增加而更快速地启动。
10.一种用于组织的解剖和凝固的设备，包括：
具有端部执行器的外科器械，所述端部执行器被构造成能够在其远侧端部处解剖和密封组织；
发生器，所述发生器电联接到所述外科器械并且被构造成能够在启动周期期间将功率输出传送到所述端部执行器；和
外科模式选择器输入件，所述外科模式选择器输入件具有多个外科模式供用户选择，使得第一外科模式对应于用于控制来自所述发生器的功率输出的第一算法并且第二外科模式对应于用于控制来自所述发生器的功率输出的第二算法，其中所述第一算法与所述第二算法是不同的，其中所述外科器械包括被构造成能够在第一位置和第二位置之间运动的闭合开关，并且其中对应于所述多个外科模式的所述第一算法和所述第二算法中的一个或多个包括用于在所述闭合开关定位在所述第二位置时对所述端部执行器的启动次数进行计数的阈值计数器，使得来自所述发生器的所述功率输出基于所述启动次数而改变，并且其中被传送的所述功率输出随着所述启动次数增加而更接近所述启动周期开始时的功率输出。
11.根据权利要求10所述的设备，其中所述外科模式选择器输入件呈所述外科器械上的选择器开关的形式，使得所述选择器开关能够在所述多个外科模式之间切换以控制向所述端部执行器的所述功率输出。
12.根据权利要求10所述的设备，其中所述外科模式选择器输入件呈插座的形式，所述插座用于位于所述发生器上的输入装置。
13.根据权利要求12所述的设备，其中所述输入装置为射频识别(RFID)刷钥匙。
14.根据权利要求12所述的设备，其中所述输入装置为通用串行总线(USB)。
15.根据权利要求12所述的设备，其中所述多个外科模式包括定制的外科模式，其中所述输入装置包括所述定制的外科模式，用于控制所述发生器向所述端部执行器的功率输出。
16.根据权利要求15所述的设备，其中所述外科模式选择器输入件呈与所述发生器通信的外部通信装置的形式。
17.根据权利要求16所述的设备，其中所述外部通信装置被构造成能够与所述发生器无线通信。
18.一种用于组织的解剖和凝固的设备，包括：
定位在外科器械的远侧端部上的端部执行器，所述端部执行器被构造成能够解剖和密封组织；
所述外科器械上的闭合开关，所述闭合开关被构造成能够控制所述端部执行器，使得所述端部执行器在所述闭合开关处于第一位置时为打开的，并且使得所述端部执行器在所述闭合开关处于第二位置时为闭合的；
发生器，所述发生器电联接到所述外科器械并且被构造成能够在启动周期期间将功率输出传送到所述端部执行器；和
外科模式选择器输入件，所述外科模式选择器输入件具有多个外科模式供用户选择，使得每个外科模式对应于用于控制来自所述发生器的功率输出的特定算法；
其中所述发生器被构造成能够在所述闭合开关处于所述第二位置并且所述端部执行器围绕组织闭合时将所述功率输出传送到所述端部执行器，其中对应于所述多个外科模式的所述特定算法中的一个或多个特定算法包括用于在所述闭合开关定位在所述第二位置时对所述端部执行器的启动次数进行计数的阈值计数器，使得来自所述发生器的所述功率输出基于所述启动次数而改变，并且其中被传送的所述功率输出随着所述启动次数增加而更接近所述启动周期开始时的功率输出。
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