CN104349731A - 具有取向感测的外科器械 - Google Patents

具有取向感测的外科器械 Download PDF

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CN104349731A
CN104349731A CN201380028273.0A CN201380028273A CN104349731A CN 104349731 A CN104349731 A CN 104349731A CN 201380028273 A CN201380028273 A CN 201380028273A CN 104349731 A CN104349731 A CN 104349731A
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energy
control module
end effector
storage device
orientation sensors
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CN104349731B (zh
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D·W·普莱斯
S·莱
C·G·金博尔
T·G·迪茨
A·K·马登
D·L·科尔维克
F·B·斯图伦
J·D·梅瑟利
J·C·阿伦哈尔特
W·D·丹纳赫
J·B·舒尔特
D·P·希尔凯图斯
S·J·巴利克
M·R·拉姆平
W·E·克莱姆
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Ethicon Endo Surgery Inc
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A—HUMAN NECESSITIES
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
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    • A61B18/14—Probes or electrodes therefor
    • A61B18/1442—Probes having pivoting end effectors, e.g. forceps
    • A61B18/1445—Probes having pivoting end effectors, e.g. forceps at the distal end of a shaft, e.g. forceps or scissors at the end of a rigid rod
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A—HUMAN NECESSITIES
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B2017/320095—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw with sealing or cauterizing means
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
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    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0814—Preventing re-use
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
    • F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
    • F04C2270/00—Control; Monitoring or safety arrangements
    • F04C2270/04—Force
    • F04C2270/041—Controlled or regulated

Abstract

本发明公开了一种包括主体组件和端部执行器的外科器械。所述主体组件包括控制模块、通信地联接到所述控制模块的取向传感器和能量部件。所述能量部件能够操作以在多个能量设置下启动所述端部执行器。存储装置通信地联接到所述控制模块并且包括多个姿态简档和相应能量设置。所述控制模块能够响应于所述取向传感器的输出与姿态简档之间的相关性而将所述能量部件的能量设置设定为相应能量设置。在一些型式中，所述控制模块基于来自测量所述端部执行器上的力的力传感器的输出来修改所述能量设置。所述控制模块还可响应于由加速计所检测到的异常加速或减速而减小所述能量设置。

Description

具有取向感测的外科器械
背景技术
在一些情况下，内窥镜式外科器械可以优于传统的开放式外科装置，因为较小切口可减少术后恢复时间和并发症。因此，一些内窥镜式外科器械可适于穿过套管针的插管来将远侧端部执行器放置在期望手术部位处。这些远侧端部执行器能以多种方式来接合组织以便达到诊断或治疗的效果，所述远侧端部执行器如：直线切割器、抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗递送装置和使用超声、射频、激光等的能量递送装置。内窥镜式外科器械可包括轴，该轴介于端部执行器与临床医生所操纵的柄部部分之间。这样的轴可以允许插入期望深度并绕轴的纵向轴线旋转，由此利于将端部执行器定位在患者体内。在一些情况下，用户可能需要在有效地和高效地使用这类装置来执行各种手术之前多次使用所述器械。此适应时间可使一些用户避免采用新的器械。因此，为各种用户助手提供外科器械以降低针对如何使用所述器械的学习曲线可能是有益的。
可以能够包括此类用户界面助手的此类内窥镜式外科器械的例子可包括下述专利所公开的那些：2002年12月31日提交的名称为“ElectrosurgicalSystems and Techniques for Sealing Tissue”的美国专利6,500,176，其公开内容以引用方式并入本文；2008年8月26日公布的名称为“Motor-DrivenSurgical Cutting and Fastening Instrument with Loading Force Feedback”的美国专利7,416,101，其公开内容以引用方式并入本文；2010年6月15日公布的名称为“Post-Sterilization Programming of Surgical Instruments”的美国专利7,738,971，其公开内容以引用方式并入本文；2006年4月13日公布的名称为“Tissue Pad for Use with an Ultrasonic Surgical Instrument”的美国专利公布2006/0079874，其公开内容以引用方式并入本文；2007年8月16日公布的名称为“Ultrasonic Device for Cutting and Coagulating”的美国专利公布2007/0191713，其公开内容以引用方式并入本文；2007年12月6日公布的名称为“Ultrasonic Waveguide and Blade”的美国专利公布2007/0282333，其公开内容以引用方式并入本文；2008年8月21日公布的名称为“Ultrasonic Device for Cutting and Coagulating”的美国专利公布2008/0200940，其公开内容以引用方式并入本文；2009年8月20日公布的名称为“Motorized Surgical Cutting and Fastening Instrument Having HandleBased Power Source”的美国专利公布2009/0209990，其公开内容以引用方式并入本文；和2010年3月18日公布的名称为“Ultrasonic Device forFingertip Control”的美国专利公布2010/0069940，其公开内容以引用方式并入本文；美国专利公布2011年1月20日公布的名称为“Rotating TransducerMount for Ultrasonic Surgical Instruments”的美国专利公布2011/0015660，其公开内容以引用方式并入本文；和2011年4月14日公布的名称为“SurgicalInstrument Comprising First and Second Drive Systems Actuatable by a CommonTrigger Mechanism”的美国专利公布2011/0087218，其公开内容以引用方式并如本文。另外，前述外科工具中的一些可包括诸如下述专利所公开的无线换能器：2009年6月4日公布的名称为“Cordless Hand-held UltrasonicCautery Cutting Device”的美国专利公布2009/0143797，其公开内容以引用方式并入本文。
所述外科器械中的一些可用于或适用于诸如下述专利所公布的机器人辅助外科设置：2004年8月31日公布的名称为“Robotic Surgical Tool withUltrasound Cauterizing and Cutting Instrument”的美国专利6,783,524。
尽管各种装置和方法已制备并用于内窥镜式外科手术，但据信在本发明人之前还没有人制备或使用本文所述的技术。
附图说明
本说明书后附的权利要求书特别指出并明确主张本技术，但据信从下面结合附图对某些例子所作的描述将会更好地理解本技术，附图中类似的参考标号表示相同元件，且其中：
图1示出了具有一个或多个取向传感器的示例性外科器械的方框示意图；
图2示出了示例性外科器械的透视图；
图3示出了第二示例性外科器械的侧视剖面图，其显示了第一示例性取向传感器组件；
图4示出了示例性取向传感器的局部侧视剖面图，所述传感器具有设置在传感器壳体内的导电球体；
图5示出了图4的导电球体的侧正视图，其显示了多个导电区段和平衡块；
图6示出了替代取向传感器的后方局部剖面透视图；
图7示出了示例性可拆卸端部执行器顶盖的局部透视图；
图8示出了示例性外科器械的透视图，其显示了第一示例性姿态；
图9示出了示例性外科器械的透视图，其显示了第二示例性姿态；
图10示出了示例性外科器械的透视图，其显示了第三示例性姿态；
图11示出了用于监控示例性外科器械的运动的示例性步骤的流程图；并且
图12示出了响应于一个或多个传感器的监控而执行的示例性步骤的流程图。
附图并非旨在以任何方式进行限制，并且可以预期本技术的各种实施例能够以多种其它方式来执行，包括那些未必在附图中示出的方式。并入本说明书中并构成其一部分的附图示出了本技术的若干方面，并与说明书一起用于解释本技术的原理；然而，应当理解，本技术不限于所示出的精确布置方式。
具体实施方式
本技术的某些例子的下述描述不应当用于限制其范围。通过以下举例说明(被认为是用于实施本技术的最佳方式之一)，本技术的其它例子、特征、方面、实施例和优点对于本领域技术人员将变得显而易见。正如将会意识到的，本文所述的技术包括其它不同且明显的方面，这些都未脱离本技术。因此，附图和具体实施方式应被视为实质上是示例性而非限制性的。
因此，应当理解，本文所述的教导内容、表达方式、实施例、例子等中的任何一者或多者可与本文所述的其它教导内容、表达方式、实施例、例子等中的任何一者或多者相结合。因此，下述教导内容、表达方式、实施例、例子等不应视为彼此隔离。参考本文教导内容，其中本文教导内容可结合的各种合适方式对于本领域的普通技术人员而言将会显而易见。此类修改形式和变型旨在包括在权利要求书的范围内。
I.综述
图1示出了示例性外科器械10，所述器械包括柄部组件12和可拆卸端部执行器90。当然，应当理解，在一些型式中，端部执行器90可固定联接到柄部组件12或固定联接到轴22。在本例中，柄部组件12包括壳体14，所述壳体包括能量部件20、第一传感器30、控制模块40、存储装置50、用户界面60、功率源70、第二传感器80和第一连接器88。在本例中，能量部件20联接到功率源70并且能够操作以启动端部执行器90。仅以举例的方式，能量部件20可包括超声换能器，所述超声换能器具有轴22，所述轴能够操作以在端部执行器90联接到轴22和/或柄部组件12时将超声运动传输至端部执行器90的刀片。一个例子描述于下述专利中：2011年1月20日公布的名称为“Rotating Transducer Mount for Ultrasonic Surgical Instruments”的美国专利公布2011/0015660，其公开内容以引用方式并入本文。在其它型式中，能量部件20可包括马达或能够操作以通过轴22和/或以其它方式将运动传输至端部执行器90的一个或多个部件的其它部件。一种仅为示例性的马达驱动外科器械公开于下述专利中：2008年8月26日公布的名称为“Motor-Driven Surgical Cutting and Fastening Instrument with Loading ForceFeedback”的美国专利7,416,101，其公开内容以引用方式并入本文。当然，在一些型式中，能量部件20和/或轴22可完全省略且功率源70可以能够操作以直接启动端部执行器90的一个或多个特征。例如，功率源70可以能够操作以将射频能量传输至诸如下述专利所公开的端部执行器90：2002年12月31日公布的名称为“Electrosurgical Systems and Techniques for SealingTissue”的美国专利6,500,176，其公开内容以引用方式并入本文。尽管功率源70在本例中示出为含于柄部组件12内(例如，作为一个或多个可再充电式电池)，但应当理解，功率源70可处于柄部组件12外部，诸如图2所示的发生器120。当然，参考本文的教导内容，能量部件20和/或功率源70的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。
如图1所示，控制模块40通信地联接到能量部件20、第一传感器30、存储装置50、用户界面60、功率源70、第二传感器80和第一连接器88。当然，应当理解，前述部件中的任一个可省略和/或不通信地联接到控制模块40；而且除了或代替本文所述的那些部件，控制模块40可与各种其它部件通信。控制模块40包括集成电路或微控制器，所述集成电路或微控制器能够从诸如传感器30,80,98、存储装置50和/或端部执行器存储装置96的一个或多个部件接收输入；并将控制指令输出至诸如能量部件20和/或用户界面60的一个或多个部件和/或装置，但输出仅为任选的(例如，控制模块40可仅为用于接收信息的诊断工具或部件和/或装置可与控制模块40整合在一起，使得控制模块40可直接启动或停用部件和/或装置)。在一些型式中，控制模块40还包括EEPROM以在其上存储数据。例如，EEPROM可存储机器可读代码以控制外科器械10的各种部件或EEPROM可含有存储在数据表中的一个或多个操作设置和/或模式。当然，参考本文的教导内容，EEPROM的其它机器可读代码和/或配置对于本领域普通技术人员而言将是显而易见的。此类代码也可如下文所述存储在存储装置50中。在本例中，控制模块40整合至外科器械10中，但这仅为任选的。在一些型式中，控制模块40可整合至发生器120(示于图2中)中并且通过缆线130通信地联接到器械10或控制模块40可为通信地联接到器械10的独立装置。当然，参考本文的教导内容，控制模块40的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。
本例的第一传感器30包括能够操作以检测器械10的取向和/或运动的传感器。仅以举例的方式，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，第一传感器30可包括陀螺仪传感器、倾斜仪、加速计和/或任何其它合适的取向和/或运动传感器。如图1所示，第一传感器30通信地联接到控制模块40并且能够操作以向控制模块40传输指示器械10相对于基准取向和/或运动的取向和/或运动的信号。当然，应当理解，除了或代替器械10的取向和/或运动，第一传感器30还能够提供信息。一些仅为示例性的替代传感器包括诸如下述专利中所描述的热传感器：2011年10月20日提交的名称为“Surgical Instrument with Sensor and Powered Control”的美国非临时专利申请13/277,328，其公开内容以引用方式并入本文。当然，第一传感器30仅为任选的且可省略或整合至诸如控制模块40的其它部件中。参考本文的教导内容，另一些其它传感器30对于本领域的普通技术人员而言将是显而易见的。
存储装置50通信地联接到控制模块40并且能够操作以存储或撷取控制模块40的数据。存储装置50包括计算机可读介质，所述计算机可读介质能够以其中数据或指令可由控制模块40撷取和/或处理的形式存储数据或指令。计算机可读介质不应仅限于任何特定的类型或组织，而是应理解为包括分布式和分散式系统(无论其以物理方式或以逻辑方式设置)、以及位于限定和/或限制物理和/或逻辑空间中的系统的存储对象。仅以举例的方式，存储装置50可包括硬盘、只读存储器、随机存取存储器、固态存储器元件、光盘和/或寄存器。如下文将更详细描述，存储装置50可包括器械10的一个或多个配置数据。这些配置数据可与从第一传感器30、第二传感器80和/或端部执行器传感器98提供的数据一起由控制模块40用来确定用户是否正在根据预期用法使用器械10和/或基于用户正在如何使用器械10来调整来自能量部件20的输出。当然，存储装置50仅为任选的且可省略或整合至诸如控制模块40和/或发生器120的其它部件中。参考本文的教导内容，存储装置50的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。
用户界面60也通信地联接到控制模块40，使得控制模块40可控制用户界面60。应当理解，用户界面60可包括只向用户传输信息、能够操作以接收来自用户的输入、或二者兼之的部件。例如，用户界面60可包括能够操作以发出可听音调的扬声器。仅以举例的方式，与配置数据对比，控制模块40能够响应于用户是否正在根据预期用法使用器械10而从扬声器输出不同的音调，如下文将更详细描述。此外，或作为另一选择，用户界面60可包括发光二极管或其它视觉部件，使得控制模块40可操作所述发光二极管或其它视觉部件。再者，用户界面60可包括简单的屏幕或触摸屏。屏幕可以能够操作以显示指示用户是否正在以适当的方式使用器械10的一个或多个图形输出。再者，触摸屏可以操作以选择所述配置数据中的一个或多个、选择外科手术类型和/或选择器械10的其它选项或特征。再一个型式可包括输入按钮或其它输入部件，使得用户可管理器械10的控制模块40或其它部件。当然，前述中的两者或更多者可组合用于用户界面60。例如，用户界面60可包括扬声器和多个发光二极管。在另一个型式中，用户界面60可包括扬声器和屏幕，所述屏幕显示用法的图示。在再一个型式中，用户界面60可包括扬声器和触摸屏，所述触摸屏既显示用法的图示又能够操作以选择配置数据中的一个或多个和/或选择器械10的其它选项或特征。参考本文的教导内容，另一些其它用户界面60对于本领域的普通技术人员而言将是显而易见的。此外，在一些型式中，用户界面60可省略。
本例的第二传感器80包括能够操作以检测施加至器械10的端部执行器90的力的取向或由组织对端部执行器90所施加的力的向量的传感器。仅以举例的方式，第二传感器80可包括一个或多个应变仪，所述应变仪联接到延伸于能量部件20与端部执行器90之间的轴22。在一些型式中，多个应变仪可定位于轴22周围以确定力的取向。此外，第二传感器80也可用于确定施加至端部执行器90的力的量级。第二传感器80可根据下述专利的教导内容中的至少一些进行构造：与本案同一日提交的名称为“Surgical Instrumentwith Stress Sensor”的美国专利申请序列号[代理人案卷号END7056USNP.0590477]，其公开内容以引用方式并入本文。当然，参考本文的教导内容，另一些其它传感器对于本领域的普通技术人员而言将是显而易见的。如图1所示，第二传感器80通信地联接到控制模块40并且能够操作以向控制模块40传输指示施加至器械10的轴22和/或端部执行器90的力的信号。当然，应当理解，除了或代替施加至轴22和/或端部执行器90的力，第二传感器80还能够提供信息。一些仅为示例性的替代传感器包括诸如下述专利中所描述的热传感器：2011年10月20日提交的名称为“Surgical Instrument with Sensor and Powered Control”的美国非临时专利申请13/277,328，其公开内容以引用方式并入本文。参考本文的教导内容，另一些其它传感器80对于本领域的普通技术人员而言将是显而易见的。当然，应当理解，在一些型式中，第二传感器80也可省略。
第一连接器88通信地联接到控制模块40并且能够操作以将端部执行器90电和通信地联接到控制模块40。例如，第一连接器88可包括多个电触点，所述电触点能够联接到端部执行器90的第二连接器92的多个电触点。当然，第一连接器88可具有能够操作而电和/或通信地联接到端部执行器90的其它配置(例如，感应联接器)。在一些型式(诸如其中端部执行器90固定联接到柄部组件12的那些型式)中，第一连接器88可完全省略。
本例的端部执行器90可拆卸地联接到柄部组件12并且通过轴22联接到能量部件20。用于将端部执行器90联接到柄部组件12的仅为示例性的方式包括夹子、夹钳、搭锁、钩环连接器等。此外，或另一选择为，端部执行器90可根据下述专利的教导内容中的至少一些进行构造：2011年10月10日提交的名称为“Surgical Instrument with Modular Shaft and End Effector”的美国专利申请13/269,870，其公开内容以引用方式并入本文。如同上面所述的能量部件20一样，端部执行器90能够以多种方式接合组织以达到诊断或治疗效果(例如，使用超声振动、射频、激光等的直线切割器、抓紧器、切割器、缝合器、施夹器、进入装置、药物/基因治疗递送装置和能量递送装置)。仅以举例的方式，端部执行器90可根据下述专利的教导内容中的至少一些进行构造：2011年1月20日公布的名称为“Rotating TransducerMount for Ultrasonic Surgical Instruments”的美国专利公布2011/0015660，其公开内容以引用方式并入本文；2008年8月26日公布的名称为“Motor-Driven Surgical Cutting and Fastening Instrument with Loading ForceFeedback”的美国专利7,416,101，其公开内容以引用方式并入本文；和2002年12月31日公布的名称为“Electrosurgical Systems and Techniques forSealing Tissue”的美国专利6,500,176，其公开内容以引用方式并入本文。当然，参考本文的教导内容，端部执行器90的另一些其它配置对于本领域普通技术人员而言将是显而易见的。
端部执行器90包括第二连接器92、端部执行器存储装置96和端部执行器传感器98。如上所述，第二连接器92包括多个电触点，所述电触点能够在端部执行器90附接至柄部组件12时将端部执行器90电和通信地联接到控制模块40。本例的端部执行器存储装置96包括计算机可读介质，所述计算机可读介质能够以其中数据或指令可由控制模块40撷取和/或处理的形式存储数据或指令。计算机可读介质不应仅限于任何特定的类型或组织，而是应理解为包括分布式和分散式系统(无论其以物理方式或以逻辑方式设置)、以及位于限定和/或限制物理和/或逻辑空间中的系统的存储对象。仅以举例的方式，端部执行器存储装置96可包括硬盘、只读存储器、随机存取存储器、固态存储器元件、光盘和/或寄存器。在本例中，端部执行器存储装置96包括非易失性存储器模块，所述模块通信地联接到第二连接器92，使得当端部执行器90联接到柄部组件12时端部执行器存储装置96通信地联接到控制模块40。当然，参考本文的教导内容，端部执行器存储装置96的其它配置对于本领域普通技术人员而言将是显而易见的。再者，在一些型式中，端部执行器存储装置96可完全省略。
本例的端部执行器传感器98包括能够操作以检测端部执行器90的取向和/或运动的传感器。仅以举例的方式，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，端部执行器传感器98可包括陀螺仪传感器、倾斜仪、加速计和/或任何其它合适的取向和/或运动传感器。如图1所示，端部执行器传感器98通过第一连接器和第二连接器88,92的界面通信地联接到控制模块40，且端部执行器传感器98能够操作以向控制模块40传输指示端部执行器90相对于基准取向和/或运动的取向和/或运动的信号。当然，应当理解，除了或代替端部执行器90的取向和/或运动，端部执行器传感器98能够提供信息。例如，端部执行器传感器98能够检测施加至端部执行器90的刀片(未示出)的力并且可根据上文所述的第二传感器80的教导内容中的至少一些进行构造。此外，或另一选择为，一些仅为示例性的其它传感器包括诸如下述专利所述的热传感器：2011年10月20日提交的名称为“Surgical Instrument with Sensor and Powered Control”的美国非临时专利申请13/277,328，其公开内容以引用方式并入本文。参考本文的教导内容，另一些其它端部执行器传感器98对于本领域的普通技术人员而言将是显而易见的。此外，应当理解，在一些型式中，端部执行器传感器98可完全省略。
II.示例性外科系统和外科器械
尽管前述方框示意图大体描述了一种可联接到端部执行器90并且包括用于向控制模块40提供反馈的各种部件的外科器械10，但现在将描述外科器械10和/或外科系统的各种配置。
A.具有手枪式握把的示例性细长超声外科器械
图2显示了可结合上文所述的部件中的一者或多者的示例性超声外科系统100。在本例中，系统100包括超声外科器械150、发生器120和缆线130，所述缆线能够操作以将发生器120联接到外科器械150。合适的发生器120为由Cincinnati,Ohio的Ethicon Endo-Surgery公司出售的GEN 300。仅以举例的方式，发生器120可根据下述专利的教导内容进行构造：2011年4月14日公布的名称为“Surgical Generator for Ultrasonic and ElectrosurgicalDevices”的美国专利公布2011/0087212，其公开内容以引用方式并入本文。发生器120可包括上文所述的控制模块40、存储装置50、用户界面60和/或功率源70中的一者或多者，但这些仅为任选的。应该指出的是，外科器械150参照超声外科器械进行描述；然而，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，下文所述的技术可用于多种外科器械，包括但不限于内切割器、抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗递送装置、以及使用超声、射频、激光等的能量递送装置和/或它们的任何组合。此外，尽管本例参照缆线连接的外科器械150进行描述，但应当理解，外科器械150可适合于诸如下述专利所公开的无线操作：2009年6月4日公布的名称为“Cordless Hand-held Ultrasonic CauteryCutting Device”的美国专利公布2009/0143797，其公开内容以引用方式并入本文。此外，外科装置150也可用于或适用于诸如下述专利所公开的机器人辅助的外科设置：2004年8月31日公布的名称为“Robotic Surgical Toolwith Ultrasound Cauterizing and Cutting Instrument”的美国专利6,783,524。
本例的外科器械150包括多部件柄部组件160、细长的传输组件170和换能器190。应当理解，外科器械150可视为上文所述的外科器械10的示例性型式。传输组件170在其近端处连接至多部件柄部组件160并且从多部件柄部组件160朝远侧延伸。在本例中，传输组件170能够细长的、细管状组件以用于内窥镜式用途，但应当理解，作为另外一种选择，传输组件170可为诸如图3、图6和图9-11所示和/或下述专利所公开的短组件：2007年12月6日公布的名称为“Ultrasonic Waveguide and Blade”的美国专利公布2007/0282333和2008年8月21日公布的名称为“Ultrasonic Device forCutting and Coagulating”的美国专利公布2008/0200940，其公开内容以引用方式并入本文。本例的传输组件170包括外部护套172、内部管状致动构件(未示出)、波导(未示出)和位于传输组件170的远端上的端部执行器180。在本例中，端部执行器180包括联接到波导的刀片182、能够操作以在传输组件170的近端处枢转的夹持臂184和任选的一个或多个可联接到夹持臂184的夹持垫186。端部执行器180还可根据上文参照图1所述的端部执行器90进行配置。还应当理解，如果需要，夹持臂184可完全省略。
能够将超声能量从换能器190传输至刀片182的波导可以为柔性、半柔性或刚性的。在一些型式中，第二传感器80可联接到波导以检测何时对刀片182施加力(例如，当刀片182靠在组织上时)。换能器190为可使用的示例性能量部件20。一种仅为示例性的超声换能器190为由Cincinnati,Ohio的Ethicon Endo-Surgery公司出售的型号HP054。还应当理解，夹持臂184和相联的特征可根据下述专利的教导内容中的至少一些进行构造并操作：1999年11月9日公布的名称为“Ultrasonic Clamp Coagulator ApparatusHaving Improved Clamp Arm Pivot Mount”的美国专利5,980,510，其公开内容以引用方式并入本文。如本领域中所熟知，波导还能够放大通过波导传输至刀片182的机械振动。波导还可具有用于控制沿波导的纵向振动的增益的特征，并且具有用于将波导调谐至系统共振频率的特征。
在本例中，刀片182的远端设置在波腹附近，以便在声学组件未由组织加载时将其调谐至优选的共振频率fo。当换能器190通电时，刀片182的远端能够在例如大约10至500微米峰间范围内、且优选地在约20至约200微米的范围内以例如55.5kHz的预定振动频率fo纵向运动。当本例的换能器190启动时，这些机械振荡通过波导传输到端部执行器180。在本例中，联接到波导的刀片182在超声频率下振荡。因此，当组织固定在刀片182与夹持臂184之间时，刀片182的超声振荡可同时切断组织并且使邻近组织细胞中的蛋白变性，由此提供具有相对较少热扩散的促凝效果。也可通过刀片182和夹持臂184提供电流以另外烧灼组织。尽管已描述传输组件170和换能器190的一些配置，但参考本文的教导内容，传输组件170和换能器190的另一些其它合适配置对于本领域普通技术人员而言是显而易见的。
本例的多部件柄部组件160包括配对外壳部分162和下部164。配对外壳部分162能够在配对外壳部分162的近端接纳换能器190并且在配对外壳部分162的远端接纳传输组件170的近端。在配对外壳部分162的远端上设有孔以用于插入各种传输组件170。本例示出了用于旋转传输组件170和/或换能器190的旋转旋钮166，但应当理解，旋转旋钮166仅为任选的。配对外壳部分162和/或传输组件170还可根据下述专利的教导内容中的至少一些进行构造：2011年10月10日提交的名称为“Surgical Instrument withModular Shaft and End Effector”的美国专利申请13/269,870，其公开内容以引用方式并入本文。多部件柄部组件160的下部164包括触发器168并且能够由用户单手抓握。下部164的一个仅为示例性的替代配置示出于下述专利的图1中：2011年1月20日公布的名称为“Rotating Transducer Mount forUltrasonic Surgical Instruments”的美国专利公布2011/0015660，其公开内容以引用方式并入本文。应当理解，包括于柄部组件12中的各种部件可结合到多部件柄部组件160中。
此外，尽管已参照两个不同部分162,164描述了多部件柄部组件160，但应当理解，多部件柄部组件160可为组合有这两个部分162,164的一体组件。作为另外一种选择，多部件柄部组件160可分成诸如单独的启动部分(可由用户的手或脚操作)和单独的配对外壳部分162的多个分立部件。启动部分可以能够操作以启动换能器190并且可远离配对外壳部分162。如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，多部件柄部组件160可由耐用塑料(诸如聚碳酸酯或液晶聚合物)、陶瓷和/或金属、或任何其它合适的材料构成。参考本文的教导内容，多部件柄部组件160的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。例如，器械150可作为机器人系统的一部分进行操作。参考本文的教导内容，多部件柄部组件160的其它配置对于本领域的普通技术人员也将是显而易见的。仅以举例的方式，外科器械150可根据下述专利的教导内容中的至少一些进行构造：美国专利公布2006/0079874；美国专利公布2007/0191713；美国专利公布2007/0282333；美国专利公布2008/0200940；美国专利公布2011/0015660；美国专利6,500,176；美国专利公布2011/0087218；和/或美国专利公布2009/0143797。
B.具有铅笔式握把的示例性手持式超声外科器械
图3示出了能够类似于钢笔或铅笔握在用户手中的替代外科器械200。外科器械200也可视为上文所述的外科器械10的另一示例性型式。如本例所示，器械200包括壳体202、可旋转换能器210、端部执行器220和取向传感器组件230。壳体202被设定尺寸和配置成其中容纳有换能器210和取向传感器组件230。如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，壳体202可由耐用塑料(诸如聚碳酸酯或液晶聚合物)、陶瓷和/或金属、或任何其它合适的材料构成。换能器210通过安装架204可旋转地安装至壳体202。换能器210通过延伸穿过壳体202的近端的导线214和缆线206电联接到诸如发生器120的发生器(未示出)。换能器210还包括朝远侧延伸至端部执行器220的波导212。换能器210可根据上述换能器190的教导内容中的至少一些和/或以其它方式进行构造。
端部执行器220联接到壳体202的远端并且包括联接到波导212的刀片222。因此，当换能器210通电时，刀片222的远端能够在例如大约10至500微米峰间范围内、且优选地在约20至约200微米的范围内以例如55.5kHz的预定振动频率fo纵向运动。因此，当紧贴组织施加刀片222时，刀片222的超声振荡可同时切断组织并且使邻近组织细胞中的蛋白变性，由此提供具有相对较少热扩散的促凝效果。在一些型式中，端部执行器220可拆卸地联接到壳体202，使得各种端部执行器220可与器械200一起使用。当然，参考本文的教导内容，端部执行器220的其它配置对于本领域普通技术人员而言将是显而易见的。
取向传感器组件230安装于壳体202内并且包括一个或多个传感器232,234，所述传感器能够感测器械200的取向和/或运动。在本例中，取向传感器组件230包括具有陀螺仪232和加速计234的集成电路或微处理器。仅以举例的方式，取向传感器组件230可包括MEMS(微机电系统)陀螺仪/加速计。取向传感器组件230通过导线236电联接到控制模块(未示出)。在一些型式中，控制模块可整合至发生器中，而在其它型式中，控制模块可为单独的装置。在另一些其它型式中，控制模块可与取向传感器组件230整合在一起。当然，应当理解，器械10的一个或多个部件也可结合到器械200中。本例的陀螺仪232能够操作以提供相对于基准取向的取向数据。仅示例性的基准取向可包括器械200处于图3所示的纵向取向、垂直于图3所示的取向的垂直取向和/或任何其它取向。加速计234能够操作以提供器械200相对于静止位置和/或其它惯性状态的运动。因此，使用陀螺仪232和加速计234，可确定器械200的取向和运动。当然，参考本文的教导内容，取向传感器组件230的其它配置对于本领域的普通技术人员而言将是显而易见的。
III.示例性替代取向传感器
尽管前述内容描述能够操作以感测前述器械10,150,200的取向的第一传感器30和陀螺仪232，但应当理解，其它取向传感器也可与器械10,150,200,400,500,600一起使用。此外，在一些情况下，器械10,150,200,400,500,600能够通过高压灭菌器的重新消毒再度使用。在这种情况下，常规电子部件可能经不住重新消毒过程。因此，可经得住重新消毒过程的各种替代取向传感器可为优选的。尽管下文所述的示例性传感器中的一些可经得住各种重新消毒过程，但这样的功能不一定需要结合到这类传感器的所有型式中。
一个仅为示例性的替代取向传感器300显示于图4-5中。如图4所示，传感器300包括球形物310和壳体350。球形物310在壳体350内基本上自由地旋转和/或转动。参见图5，球形物310包括球体312和设置在球体312的外表面上的多个导电路径314。在本例中，球体312包括非导电聚合物球体，所述非导电聚合物球体具有包覆成型到球体312上的多个铜路径314。路径314为分立的并且相对于彼此电隔离。平衡块320提供于球体312的一端内，使得平衡块320使球体312的端通过重力向下朝地面取向。因此，即使改变结合取向传感器300的器械10,150,200的取向，平衡块320也保持球体312相对于地面的取向。本例的路径314在球体312上布置成各种取向，使得所述多个路径314能够接合一个或多个电极354，如下文将更详细描述。当球形物310在壳体350内改变位置时，可通过监控电联接到电极354的多个传感器356来确定球形物310的位置，如下文将更详细描述。
当然，应当理解，也可使用球形物310的其它配置。例如，路径314还可布置在球体312周围，使得每个路径均具有相对于其它路径314的唯一起点和终点。在一些型式中，可在路径314上放置非导电材料，使得只暴露每个路径314的起点和终点。因此，路径314可以各种各样的方式布置(例如，L形路径、V形路径、路径之间插置有非导电材料的交叠路径等)，使得可通过监控传感器356来确定球形物310的位置。在另一型式中，球体312可包括导电球体，所述导电球体具有在球体312的外部上成层的非导电或绝缘材料层。路径314可通过移除非导电材料使得暴露导电球体312的部分而形成。在另一配置中，球体312可只包括导电球体且路径314可省略。在这样一个型式中，球体312的尺寸可被设定成只接触几个电极354，使得所接触的电极354指示球体312相对于壳体350的位置。参考本文的教导内容，球形物310的另一些其它配置对于本领域普通技术人员而言将是显而易见的。
重新参考图4，壳体350包括壳体352，所述壳体具有从壳体352向内延伸的多个电极354。在本例中，电极354包括弹簧针，所述弹簧针从壳体352向内延伸并且被布置成使得电极354球状地包封并接触球形物310。在一些型式中，电极354的末端包括半球形圆端。在其它型式中，电极354可包括片簧电极。当然，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，也可使用任何其它电极354和/或电极354的其它几何形状。在本例中，球形物310的尺寸被设定成使得电极354接触球形物310以与取向无关地始终保持每个电极354与球形物310的某一部分之间的接触。因此，多个路径314可将多个电极354电联接在一起。在一些型式中，可用非导电流体来填充壳体352以利于球形物310相对于壳体352和电极354的旋转。
在本例中，两个电极354联接到相应传感器356，使得当通过球形物310的路径314电联接电极354时，关闭传感器356的电路。尽管图4示出了处于一个平面上的五个传感器356设置在球形物310周围，但应当理解，传感器356和电极354球状地包封球形物310。传感器356如图1所示通信地联接到控制模块40，使得控制模块40能够操作以读取来自所述多个传感器356的输出。基于来自传感器356的输出，控制模块40能够确定器械10,150,200,400,500,600的取向。仅以举例的方式，联接到第一传感器356的第一电极354可具有从功率源(诸如上文所述的功率源70和/或发生器120)施加至其的第一电压。当路径314将此第一电极354电联接到传感器356的第二电极354时，传感器356将对所述电压的检测输出至控制模块40。仅以举例的方式，路径314、传感器356和电极354可被布置成使得单个路径314针对给定取向电联接单个传感器356的电极354。因此，可基于哪个传感器356具有闭合电路来确定器械10,150,200,400,500,600的取向。传感器356、电极354和路径314可在尺寸上减小并在数量上增加以提供器械10,150,200,400,500,600的取向的更大分辨率。此外，可测量电极354和传感器356的电连接之间的变化率以提供关于器械10,150,200,400,500,600的运动速度和方向的数据。
当然，参考本文的教导内容，壳体350的其它配置对于本领域的普通技术人员而言将是显而易见的。例如，在一个替代型式中，球形物310的尺寸可被设定成小于由电极354形成的室，使得球形物310在任何给定取向下仅接触两个电极354。电极354可被布置成在对其施加电压的电极354与联接到传感器356的电极354之间交替。因此，可基于哪个传感器365具有施加至其的电压来确定器械10,150,200,400,500,600的取向。应当理解，在当前例子中，仅靠近具有平衡块320的球形物310的端部定位的那些电极354将接触球形物310。参考本文的教导内容，替代取向传感器300的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。
图6示出了结合到外科器械400中的另一取向传感器410。本例的传感器410包括形成于器械400内的环形通道420、设置在通道420内的多个传感器430和其大小被设定成随着器械400的取向的改变而在通道420内滚动的滚珠450。本例的滚珠450包括其大小被设定成配合并且行进于通道420内的金属滚珠。当然，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，滚珠450可包括基于耐用聚合物的滚珠(诸如聚碳酸酯或液晶聚合物)、陶瓷和/或金属、或任何其它合适的材料。本例的通道420相对于器械400的端部执行器402横向取向，使得传感器410能够操作以确定器械400围绕纵向轴线408的旋转取向，但此仅为任选的。在一些型式中，通道420能够确定器械400围绕垂直轴线(未示出)和/或侧向轴线(未示出)的旋转取向。当然，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，多个通道420可结合至器械400中和/或通道420可具有任何其它取向。例如，在一些型式中，对应三个纵向轴线的三个通道420可提供于器械400内。
多个传感器430设置于通道420内并且能够检测滚珠450在通道420内的位置。在本例中，传感器430包括能够检测滚珠450在传感器430上的重量的力传感器和/或接触传感器。应当理解，滚珠450将在通道420内滚动并且将与通道420的最低点对齐。因此，检测滚珠450的传感器430将大致指示器械400相对于纵向轴线408的取向。在本例中，传感器430设置在通道420的圆周周围，使得滚珠450始终接触至少一个传感器430，且在一些情况下，两个传感器430。当然，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，也可使用其它传感器430，诸如压电传感器、应变仪、触觉传感器、测力仪、霍尔效应传感器等。此外，在一些型式中，可使用指示滚珠450的存在的传感器430的变化率来确定器械400的运动。参考本文的教导内容，取向传感器410的另一些其它配置对于本领域的普通技术人员而言将是显而易见的。
IV.具有预加载姿态数据的示例性可拆卸端部执行器
图7示出了示例性外科器械500的端部和示例性可拆卸端部执行器550。应当理解，外科器械500表示上文所述的外科器械10的再另一个示例性变型。在所示例子中，器械500包括壳体502、从壳体502延伸的换能器轴510和壳体502上的多个电触点520。换能器轴510能够通过螺纹联接到端部执行器550的波导560，使得来自器械500内的换能器的超声振动可传输至端部执行器550的刀片(未示出)。在所示例子中，换能器轴510包括从远离壳体502的最远点的距离d处开始的螺纹部分512。距离d对应键块(keyblock)570的纵向长度，使得当键块570联接到壳体502时，螺纹部分512位于端部执行器550的旋转套筒580内。因此，波导560可在键块570与壳体502接合时通过螺纹联接到换能器轴510。触点520为邻接端部执行器550上的互补触点(未示出)使得端部执行器550的一个或多个部件电联接到器械500的金属构件。在一些型式中，触点520还电联接到诸如控制模块40的控制模块。当然，参考本文的教导内容，端部执行器550与器械500之间的电联接特征对于本领域的普通技术人员而言将是显而易见的。在本例中，触点520设置于壳体502的键槽部分504内，使得端部执行器550只可以单个取向联接到壳体502。因此，键槽部分504可确保触点520与端部执行器550的互补触点对齐。参考本文的教导内容，器械500的另一些其它配置对于本领域普通技术人员而言将是显而易见的。
端部执行器550包括波导560、旋转套筒580、键块570和模块590。在本例中，波导560联接到旋转套筒580，使得旋转套筒580的旋转使波导560旋转。波导560从旋转套筒580朝远侧延伸并且终止于刀片(未示出)处。应当理解，除了或代替刀片，可从旋转套筒580朝远侧包括各种特征，诸如一个或多个夹持臂。在所示例子中，波导560包括螺纹部分562(以虚线显示)以通过螺纹将波导560联接到换能器轴510。因此，当键块570与壳体502接合时，如下文将描述，旋转套筒580能够操作以通过螺纹将波导560联接到换能器轴510。当然，参考本文的教导内容，波导560和换能器轴510的其它联接特征对于本领域的普通技术人员而言将是显而易见的。本例的健块570包括键部分572、中心膛孔578(以虚线显示)和安装至键块570的模块590。中心镗孔578被设定尺寸和配置成允许换能器轴510插穿过键块570以接合波导560，如上文所述。键部分572能够插入到壳体502的键槽部分504中，使得键块570相对于壳体502可旋转地固定。因此，当键块570与壳体502接合时，健块570为旋转套筒580提供机械接地。键部分572还包括上文所述的触点520的互补触点。键部分572与键槽部分504的接合能够可旋转地对齐所述组触点，使得当键块570与壳体502接合时，所述组触点电联接。互补触点联接到模块590，使得当端部执行器550联接到器械500时，模块590电联接到触点520。
在本例中，模块590包括能够操作以存储一个或多个配置数据的非易失性固态存储器模块。例如，模块590可含有配置数据，所述数据具有一个或多个姿态简档，所述姿态简档由外科器件500的控制模块(诸如参考图1所述的控制模块40)用来将器械500的用户的运动与由配置数据定义的预期姿态简档对比。这样的对比可用于随着手术的进行而赋予用户反馈和/或调整器械500的设置，如下文将参考图11-12更详细描述。当端部执行器550联接到器械500时，模块590交接器械500的控制模块以向控制模块提供配置数据。仅以举例的方式，图8-10示出了具有端部执行器650的器械600，所述端部执行器具有三个不同姿态简档以及三个不同的能量设置的配置数据。如图8所示，当以指示根据箭头610的扫掠或挖掘运动的方式使用器械600时，可对器械600的换能器应用第一能量设置。如图9所示，当以指示根据箭头620的按压运动的方式使用器械600时，可对器械600的换能器应用第二能量设置。如图10所示，当以指示根据箭头630的刮削运动的方式使用器械600时，可对器械600的换能器应用第三能量设置。当然，参考本文的教导内容，另一些其它运动和/或运动组合对于本领域的普通技术人员而言将是显而易见的。
应当理解，在一些型式中，每个端部执行器550均可包括模块590内的单个姿态简档和单个相应能量设置的配置数据。因此，附接不同的端部执行器550向控制模块提供各个姿态简档和能量设置的不同配置数据。因此，可为用户提供可与要执行的不同姿态相关联的多个端部执行器550。这些端部执行器550可包括一个或多个视觉指示器以辨别那个端部执行器与各种姿态相关联。仅以举例的方式，端部执行器550的键块570和/或其它部分可根据颜色而不同。作为另外一种选择，可在端部执行器550上包括文本或图形符号以辨别端部执行器550。当然，参考本文的教导内容，另一些其它指示器对于本领域的普通技术人员而言将是显而易见的。在一些型式中，可在用于手术的套件中提供一组这些端部执行器550，使得用户可易于更换端部执行器550以完成给定手术。
在一些情况下，模块590可由用户存取，使得用户可定义模块590的配置数据。例如，用户能够定义配置数据的姿态简档和能量设置可为优选的。此种用户定义的配置数据可通过用户界面(诸如交接模块590、用户界面60等的计算机程序与界面单元)来修改以定义姿态简档和能量设置。在一些型式中，定义姿态简档和能量设置可基于在用户在其中用户设定能量设置并执行要与能量设置相关联的姿态的配置模式期间使用器械500时对来自器械500的传感器的输出的监控。在另一些其它型式中，模块590可结合其它部件和/或处理来自这些其它部件(诸如上文所述的端部执行器98和/或加速计234)的数据。参考本文的教导内容，另一些其它端部执行器550和/或模块590对于本领域的普通技术人员将是显而易见的。
V.示例性控制方法
如上所述，在一些型式中，向用户提供反馈和/或基于交接控制模块40的传感器30,80,98,232,234,300,410的输出和/或基于对含于配置数据内的一个或多个姿态简档的对比来调整外科器械10,150,200,400,500,600的设置可能是优选的。这样的反馈和/或调整可因不需要用户针对每个姿态简档手动地调整外科器械10,150,200,400,500,600的能量设置而降低用户的学习曲线和/或促进手术的性能。此外，如果器械10,150,200,400,500,600遇到意外运动，则控制模块40能够基于来自各种传感器30,80,98,232,234,300,410的输入来调整器械10,150,200,400,500,600的设置。因此，现在将描述一种用于自适应性地控制器械10,150,200,400,500,600的示例性方法。
图11示出了一种用于基于用户使用器械10,150,200,400,500,600以及基于各种预定义的姿态简档(诸如图8-10所示的那些姿态简档)调整能量设置的方式使用控制模块40来控制器械(诸如器械10,150,200,400,500,600)的示例性方法。在本例中，控制模块40接收来自传感器30,80,98,232,234,300,410的数据并且将传感器数据与来自配置数据的一个或多个姿态简档对比。所述一个或多个姿态简档各自具有控制模块40应用于器械10,150,200,400,500,600的能量部件(诸如能量部件20或换能器190)的相应能量设置。配置数据存储在存储装置(诸如模块590和/或存储装置50)中，并且通信地联接到控制模块40。
如图11所示，所述方法在方框700处以确定要执行哪种手术(例如，整形外科手术、矫形外科手术等)开始。例如，端部执行器(诸如端部执行器550)能够包括器械10,150,200,400,500,600针对特定任务或手术的配置数据。因此，将端部执行器联接到外科器械10,150,200,400,500,600可简单地通过控制模块40在端部执行器联接到器械10,150,200,400,500,600时接收配置数据来确定手术。在另一个型式中，手术或任务的数据库可存储在存储装置50上且各种手术或任务可通过用户界面(诸如用户界面60)选择。这些手术或任务可具有可在方框710处加载的相应配置数据。参考本文的教导内容，用于确定要执行的手术的另一些其它方式对于本领域的普通技术人员而言将是显而易见的。当然，应当理解，方框700也可省略。
在方框710处，从存储装置和/或数据库加载配置数据。在本例中，配置数据包括一个或多个姿态简档(诸如图8-10所示的那些姿态简档)、以及针对每个姿态简档的相应能量设置。例如，换能器能够在执行图8所示的扫掠运动时以第一能级操作，而换能器能够在执行图9所示的按压运动时以第二、不同的能级操作。此外，或另一选择为，换能器的能级也可基于要执行的手术而不同。例如，涉及脆弱或敏感组织区域的手术可包括将换能器限定在低能级的能量设置，而涉及强韧或厚组织的手术可包括采用换能器的高能级的能量设置。当然，应当理解，这样的能量设置和姿态简档不仅限于超声外科器械，而是可应用于其它外科器械，诸如内切割器、抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗递送装置和/或使用射频、激光等的其它能量递送装置。在一些型式中，配置数据可在端部执行器550联接到器械500时从端部执行器550的模块590加载。作为另外一种选择，这样的配置数据可预加载于器械10,150,200,400,500,600的存储装置(诸如存储装置50)上，可从远程源加载，和/或以其它方式加载。
使用所加载的配置数据，用户在方框720处开始手术。仅以举例的方式，手术可在用户将器械10,150,200,400,500,600定位在初始姿态位置中时和/或在用户操作启动按钮或其它特征(诸如触发器168)时开始。在初始姿态位置的例项中，配置数据可包括对应各种期望的结果或手术的外科器械10,150,200,400,500,600的多个初始取向位置。例如，这些初始取向位置可包括用于切割、凝结、刮削、按压、扫掠等的位置。来自传感器30,232,234,300,410的指示器械10,150,200,400,500,600的取向的数据传输至控制模块40并与各种初始取向位置对比以确定用户想要哪个初始取向位置。一旦确定初始取向，便针对那个初始取向位置以相应能量设置启动能量部件，诸如能量部件20或换能器190。此外，或另一选择为，可提供启动按钮或其它特征以一旦用户将器械10,150,200,400,500,600定位于初始取向位置中便选择性地启动器械10,150,200,400,500,600和/或与器械10,150,200,400,500,600的取向无关地以预定初始能级启动器械10,150,200,400,500,600。在一些型式中，甚至在启动按钮由用户操作之后，器械10,150,200,400,500,600的能量部件仍可保持失活而不会被启动直到控制模块40确定执行配置数据的姿态简档之一，如下文将描述，或在一些型式中，直到执行具体开始姿态(例如，指示装置应启动的运动)。当然，上述仅为任选的。
一旦用户开始手术，控制模块40便在方框730处监控传感器30,80,98,232,234,300,410。例如，控制模块40通过来自第一传感器30、陀螺仪232、加速计234、取向传感器300和/或取向传感器410的输出来监控器械10,150,200,400,500,600的取向和/或运动。因此，控制模块40可利用取向和/或运动数据来确定由用户执行的器械10,150,200,400,500,600的各种姿态和/或运动速度。此外，或另一选择为，控制模块40通过第二传感器80和/或端部执行器传感器98来监控施加至端部执行器的力，如下文参考图12将更详细论述。当然，应当理解，其它传感器(诸如温度传感器、霍尔效应传感器等)可通过控制模块40来监控，使得控制模块40可进一步调整能量部件的能量设置或者以其它方式基于器械10,150,200,400,500,600的使用方式在器械10,150,200,400,500,600被使用时实时修改器械10,150,200,400,500,600的设置。
在方框740处，将来自方框730的传感器数据与来自配置数据的各种姿态简档对比。仅以举例的方式，针对各种姿态简档中的每一者，将在预定时间周期内来自传感器30,80,98,232,234,300,410的输出与传感器30,80,98,232,234,300,410的预期输出对比。在方框750处，控制模块40确定来自配置数据的哪个姿态简档与来自传感器30,80,98,232,234,300,410的输出最相关。例如，如果陀螺仪232指示器械10,150,200,400,500,600的取向保持基本上垂直而加速器234指示器械10,150,200,400,500,600向下运动，则控制模块40将确定正在进行图9所示的按压运动且相应的姿态简档将得以确定。对扫掠运动(图8)和/或刮削运动(图10)的类似确定可利用来自传感器30,232,234,300,410的取向和运动信息来作出。随着姿态简档得以确定，控制模块40在方框760处应用相应能量设置，使得来自能量部件的输出适用于所确定的姿态。控制模块40然后在方框730处恢复到监控传感器30,80,98,232,234,300,410。所述方法可继续以在用户执行手术时根据由来自传感器30,80,98,232,234,300,410的输出所指示的各种姿态简档来调整能量设置。因此，用户可以简单地使用器械10,150,200,400,500,600来调整其姿态以动态改变能量设置。在一些型式中，用户可释放启动按钮或其它特征以停用器械10,150,200,400,500,600，将器械10,150,200,400,500,600重新取向至指示不同能量设置的不同位置，并且重新启动器械10,150,200,400,500,600以使用新的能量设置来继续进行手术。
在一些型式中，可在配置数据中设定异常加速或减速的预定阈值。在器械10,150,200,400,500,600根据姿态简档操作时，能量设置保持不变。如果来自加速计234的输出指示已出现此异常加速或减速阈值，诸如在控制模块40监控传感器30,80,98,232,234,300,410时的方框730期间和/或在将来自传感器30,80,98,232,234,300,410的输出与各种姿态简档对比时的方框740期间，则控制模块40能够降低能量设置，或在一些型式中，完全停用器械10,150,200,400,500,600的能量部件。一旦异常加速或减速停止和/或传感器30,80,98,232,234,300,410指示正常姿态简档，便重新启动能量部件或使能量设置恢复到对应所指示的姿态简档的值。因此，如果用户在手术期间无意中失去对器械10,150,200,400,500,600的控制或遇到出乎意料软的或致密的组织，则控制模块40可以能够操作以减轻或停止刀片的超声摆动。当然，应当理解，上述不仅限于超声外科器械，而是可应用于其它外科器械，诸如内切割器、抓紧器、切割器、缝合器、施夹钳、进入装置、药物/基因治疗递送装置和/或使用射频、激光等的其它能量递送装置。
尽管上文描述应用对应各种姿态简档的各种能量设置，但图12示出了可由控制模块40响应于基于器械10,150,200,400,500,600的运动速度和施加至端部执行器的刀片的力对传感器30,80,98,232,234,300,410的监控而确定的替代组能量设置。在本例中，通过加速计(诸如加速计234)来测量器械10,150,200,400,500,600的运动并且通过力传感器(诸如第二传感器80和/或端部执行器传感器98)来测量施加至刀片的力。在方框800处，控制模块40检查来自传感器80,98,234的输出。如果传感器80,98,234指示器械10,150,200,400,500,600快速运动而刀片上的力或压力为低，则在方框810处将能量部件的能量设置设定为用于组织解剖的高速设置。如果传感器80,98,234指示器械10,150,200,400,500,600快速运动而刀片上的力或压力为高，则在方框820处将能量部件的能量设置设定为用于切穿过强韧组织或血管的中档设置。如果传感器80,98,234指示器械10,150,200,400,500,600缓慢运动而刀片上力或压力为低，则在方框830处将能量部件的能量设置设定为用于密封血管的止血模式设置。如果传感器80,98,234指示器械10,150,200,400,500,600缓慢运动而刀片上力或压力为高，则在方框840处将能量部件的能量设置设定为用于切穿过强韧组织或血管的中档设置。控制模块40可在方框800处继续检查传感器并且在方框810,820,830,840处确定适当的能量设置。还应当理解，在一些型式中，可将图12所示的能量设置结合到图11所示的方法中以替换方框730,740,750,760。当然，参考本文的教导内容，基于不同力和/或运动数据的其它设置对于本领域的普通技术人员而言将是显而易见的。
除了或代替调整能量设置，在一些型式中，器械10,150,200,400,500,600能够提供基于用户的姿态与预期用户姿态简档的对比的用户反馈。例如，如果预期扫掠运动且来自传感器30,80,98,232,234,300,410的输出指示用户正在执行扫掠运动，但进行得太慢，则控制模块40能够通过用户界面60向用户提供听觉和/或视觉反馈以指示用户进行得太慢。仅以举例的方式，当器械10,150,200,400,500,600正常操作时，可从扬声器发出周期性咔哒声，且当用户进行姿态运动太慢时，周期性咔哒声放慢。如果用户进行得太慢，则周期性咔哒声噪声可加速。当然，参考本文的教导内容，听觉反馈的其它变型对于本领域普通技术人员而言将是显而易见的。此外，或另一选择为，可提供视觉指示器以指示用户是否在姿态的优选操作范围内进行或进行得太慢或太快。例如，可提供指示相对速度的一系列发光二极管。此外，或另一选择为，可以类似于示波器或其它图形显示器的方式在屏幕上提供连续线或周期性图形显示以为用户提供其性能相对于优选操作范围的视觉反馈。控制模块40还可根据下述专利的教导内容中的至少一些进行配置：与本案同一日提交的名称为“Surgical Instrument with Stress Sensor”的美国专利申请序列号[代理人案卷号END7056USNP.0590477]，其公开内容以引用方式并入本文。此类听觉和/或视觉反馈可加速用户对各种姿态的优选操作运动的理解，从而降低器械10,150,200,400,500,600的学习曲线。参考本文的教导内容，对器械10,150,200,400,500,600的再其它用户反馈和/或调整对于本领域的普通技术人员而言将是显而易见的。
VI.其它方面
如上所述，可使用存储装置来存储与本文中所提及的各种各样的外科器械相关联的操作参数、其它数据和/或控制算法等。这样的信息可预加载和/或稍后更新；且可决定外科器械的性能特性。例如，存储装置上的软件/固件/信息可影响从发生器或其它功率源的功能传送，而这反过来又可影响由功率源驱动的端部执行器的性能。在一些系统中，发生器、功率源、控制模块和/或其它部件提供外科器械的基本功能性；而存储装置上的软件/固件/信息则提供增强的功能性(例如，主动阻尼、外科医生姿态识别、增强的用户反馈等)。应当理解，如参考本文的教导内容对于本领域的普通技术人员而言显而易见的是，存储装置可采取任何合适的形式，包括但不限于芯片、卡、或其他类型的存储介质。还应当理解，存储装置可位于系统内的任何合适位置中。仅以举例的方式，存储装置可位于诸如下述专利中所述的各种可移除仓的可移除仓中：2012年3月22日提交的名称为“Method andApparatus for Programming Modular Surgical Instrument”的美国专利申请序列号13/426,760，其公开内容以引用方式并入本文。作为另一个仅为示例性的例子，存储装置可嵌入于与外科器械和/或发生器等通信的在线远程服务器中，诸如嵌入于下述专利中所述的系统中：2012年3月22日提交的名称为“Surgical Instrument Usage Data Management”的美国专利申请序列号13/426,792，其公开内容以引用方式并入本文。作为另一仅为示例性的例子中，存储装置可被包括作为端部执行器、轴、手持件、缆线和/或外科器械的其它部件的整体部件或可移除部件。参考本文的教导内容，存储装置的各种其他合适的位置对于本领域普通技术人员而言将是显而易见的。还应当理解，存储装置可存储外科医生使用数据、患者数据和/或本文所述的其它种类的数据，使得存储装置可在外科器械的使用期间接收附加数据。
在一些型式中，外科器械的制造商或销售商以其中适当的软件/固件/信息预加载于存储装置上以供单次使用的单次使用器械形式提供外科器械。在一些这样的型式中，软件/固件/信息在外科器械被使用达到预定使用次数之后便无法存取或操作。例如，如果器械针对特定使用次数而设计，则软件/固件/信息可在超过预定义的设计寿命之后的某一时刻至少部分地被删除或禁用。在其中制造商或另一方选择对超过预定义的设计寿命的装置进行重新处理/重新消毒的情况下，经重新处理/经重新消毒的外科器械仍然可至少部分可操作，但功能性减退。例如，外科医生仍然可能能够合适地使用经重新处理/经重新消毒的外科器械，但器械可能缺乏原本通过存储在存储装置中的软件/固件/信息而提供的增强功能性(例如，主动阻尼、外科医生姿态识别、增强的用户反馈等)。在一些型式中，存储装置允许制造商或销售商根据客户的功能需要来分割器械的性能。如果客户只需要有限的功能性来执行诸如胆囊切除术的特定外科手术，则可用适当的软件/固件/信息来加载存储装置。如果客户需要增强的性能来进行困难的外科手术或者在外科手术比预期更困难的情况下扩展装置的潜在操作性能，则可相应地加载存储装置。不论是哪种情况，一些型式可允许制造商或销售商调整外科器械的功能性以满足客户对来自存储装置上的软件/固件/信息的客户定义的功能性的需要；并且在不具有增强的功能性的情况下满足不同组客户定义需要。
最后，应当理解，如本文所述的存储装置中的软件/固件/信息不一定受外科器械中的任何种类的传感器影响。例如，外科器械可能只是完全缺乏传感器；或者存储装置可能无法与传感器通信。
应当理解，本文所述教导内容、表达方式、实施例、例子等中的任何一个或多个可与本文所述其它教导内容、表达方式、实施例、例子等中的任何一个或多个结合。因此上述教导内容、表达方式、实施例、例子等不应视为彼此隔离。参考本文教导内容，其中本文教导内容可结合的各种合适方式对于本领域的普通技术人员而言将会显而易见。此类修改形式和变型旨在包括在权利要求书的范围内。
上文所述装置型式可适用于医学专家所执行的常规医疗处理和手术中，并且可适用于机器人辅助的医疗处理和手术中。仅以举例的方式，本文的各种教导内容可易于结合到诸如由Sunnyvale,California的Intuitive Surgical公司提供的DAVINCITM系统的机器人外科系统中。
上文所述型式可设计为在单次使用后丢弃，或者它们可设计为能够使用多次。在上述任一种或两种情况下，都可针对这些型式进行修复，以便在使用至少一次后重复使用。修复可以包括以下步骤任何组合：拆卸装置，然后清洗或者更换特定部件，并且随后重新组装。具体地讲，可以拆卸所述装置中的一些型式，并可选择性地以任何组合的形式更换或者移除所述装置中任何数量的特定件或部件。在清洗和/或更换特定零件时，所述装置的一些型式可在修复设施中重新组装或在即将进行手术前由用户重新组装以供随后使用。本领域的技术人员将会知道，装置修复可以利用多种技术进行拆卸、清洗/更换以及重新组装。此类技术的使用和所得修复装置全都在本申请的范围内。
仅以举例方式，本文所述型式可在手术之前和/或之后进行消毒。在一种消毒技术中，装置放置在闭合并密封的容、诸如塑料袋或TYVEK袋中。随后，可将容器和装置放置在可穿透容器的诸如γ辐射、X射线或高能电子等的辐射场中。辐射可以杀死装置上和容器中的细菌。消毒后的装置随后可以存放在消毒容器中，以备以后使用还可使用在本领域中已知的任何其它技术进行装置消毒，所述技术包括但不限于β或γ辐射、环氧乙烷或者蒸汽消毒。
尽管已在本发明中示出并描述了多个型式，但是本领域的普通技术人员可在不脱离本发明的范围的前提下进行适当修改以对本文所述的方法和系统进行进一步地改进。已经提及若干此类潜在修改形式，并且其它修改形式对于本领域的技术人员而言将会显而易见。例如，上文所讨论的例子、型式、几何形状、材料、尺寸、比率、步骤等等均是示例性而非所要求的。因此，本发明的范围应以以下权利要求书作考虑，并且应理解为不限于说明书和附图中示出并描述的结构和操作细节。

Claims (21)

1.一种设备，所述设备包括：
(a)主体组件，所述主体组件包括：
i.能量部件，其中所述能量部件能够在多个能量设置下操作，
ii.控制模块，其中所述控制模块能够操作以设定所述能量部件的能量设置，和
iii.取向传感器，其中所述取向传感器通信地联接到所述控制模块；
(b)端部执行器，其中所述端部执行器联接到所述能量部件；和
(c)存储装置，其中所述存储装置通信地联接到所述控制模块，其中所述存储装置包括配置数据，其中所述配置数据包括第一姿态简档和第一相应能量设置；
其中所述控制模块能够接收来自所述存储装置的配置数据；其中所述控制模块能够接收来自所述取向传感器的输出；其中所述控制模块能够将来自所述取向传感器的输出与所述第一姿态简档对比；并且其中所述控制模块能够响应于来自所述取向传感器的输出与所述第一姿态简档之间的相关性而将所述能量部件的能量设置设定为所述第一相应能量设置。
2.根据权利要求1所述的设备，其中所述配置数据还包括第二姿态简档和第二相应能量设置，其中所述控制模块能够将来自所述取向传感器的输出与所述第一姿态简档和所述第二姿态简档对比，其中所述控制模块能够响应于来自所述取向传感器的输出与所述第二姿态简档之间的相关性而将所述能量部件的能量设置设定为所述第二相应能量设置。
3.根据权利要求1所述的设备，其中所述端部执行器能够拆卸地联接到所述主体组件。
4.根据权利要求3所述的设备，其中所述存储装置与所述端部执行器相联。
5.根据权利要求4所述的设备，其中当所述端部执行器联接到所述主体组件时，所述存储装置能够选择性地通信地联接到所述控制模块。
6.根据权利要求1所述的设备，其中所述取向传感器包括陀螺仪。
7.根据权利要求6所述的设备，其中所述取向传感器还包括加速计。
8.根据权利要求1所述的设备，其中所述取向传感器包括环形通道、滚珠和设置在所述通道内的多个力传感器，其中所述多个力传感器能够操作以响应于所述滚珠在所述环形通道内的位置而指示所述主体组件的取向。
9.根据权利要求1所述的设备，其中所述能量部件包括超声换能器。
10.根据权利要求1所述的设备，其中所述能量部件包括射频发生器。
11.根据权利要求1所述的设备，其中所述存储装置与所述主体组件相联。
12.根据权利要求1所述的设备，其中所述取向传感器包括设置在壳体内的球形物，其中所述球形物包括导电路径，其中所述壳体包括能够选择性地电联接到所述导电路径的电极，其中所述电极能够操作以响应于当所述电极电联接到所述路径时所述球形物在所述壳体内的位置而指示所述主体组件的取向。
13.根据权利要求1所述的设备，所述设备还包括用户界面，其中所述用户界面通信地联接到所述控制模块，其中所述存储装置包括多个配置数据，其中所述用户界面能够操作以选择所述多个配置数据中的某个配置数据。
14.根据权利要求1所述的设备，所述设备还包括用户界面，其中所述用户界面通信地联接到所述控制模块，其中所述用户界面能够操作以向用户提供听觉反馈。
15.根据权利要求1所述的设备，所述设备还包括用户界面，其中所述用户界面通信地联接到所述控制模块，其中所述用户界面能够操作以向所述用户提供视觉反馈。
16.一种用于控制外科器械的方法，所述外科器械包括主体组件、端部执行器和存储装置，其中所述主体组件包括能量部件、控制模块和取向传感器，其中所述能量部件能够在多个能量设置下操作，其中所述控制模块能够操作以设定所述能量部件的能量设置，其中所述取向传感器通信地联接到所述控制模块，其中所述端部执行器联接到所述能量部件，其中所述存储装置包括多个姿态简档和多个相应能量设置，其中所述多个姿态简档中的每个姿态简档与所述多个能量设置中的相应能量设置相关联，其中所述控制模块能够接收来自所述取向传感器的数据，其中所述控制模块能够接收来自所述存储装置的多个姿态简档和多个相应能量设置，所述方法包括以下步骤：
(a)由所述控制模块接收所述取向传感器的输出；
(b)由所述控制模块接收来自所述存储装置的多个姿态简档和多个相应能量设置；
(c)将所述取向传感器的输出与所述多个姿态简档中的第一姿态简档对比；以及
(d)响应于所述取向传感器的输出与所述第一姿态简档之间的相关性而将所述能量部件设定为与所述第一姿态简档相关联的第一相应能量设置。
17.根据权利要求16所述的方法，所述方法包括以下步骤：
(a)将所述取向传感器的输出与所述多个姿态简档中的第二姿态简档对比；以及
(b)响应于所述取向传感器的输出与所述第二姿态简档之间的相关性而将所述能量部件设定为与所述第二姿态简档相关联的第二相应能量设置。
18.根据权利要求16所述的方法，其中所述主体组件还包括力传感器，所述力传感器能够操作以检测施加至所述端部执行器的力，所述方法还包括以下步骤：
(a)由所述控制模块接收所述力传感器的输出；以及
(b)基于所述力传感器的输出来调整所述第一相应能量设置。
19.根据权利要求16所述的方法，其中所述主体组件还包括加速计，所述方法还包括以下步骤：
(a)响应于由所述加速计所指示的异常加速或减速而减小所述第一相应能量设置。
20.一种用于控制外科器械的方法，所述外科器械包括主体组件、端部执行器和存储装置，其中所述主体组件包括能量部件、控制模块和取向传感器，其中所述能量部件能够在多个能量设置下操作，其中所述控制模块能够操作以设定所述能量部件的能量设置，其中所述取向传感器通信地联接到所述控制模块，其中所述端部执行器能够拆卸地联接到所述能量部件，其中所述存储装置与所述端部执行器相联，其中所述存储装置包括多个姿态简档和多个相应能量设置，其中所述多个姿态简档中的每个姿态简档与所述多个能量设置中的相应能量设置相关联，其中所述控制模块能够接收来自所述取向传感器的数据，其中所述控制模块能够接收来自所述存储装置的多个姿态简档和多个相应能量设置，所述方法包括以下步骤：
(a)由所述控制模块接收所述取向传感器的输出；
(b)由所述控制模块接收来自所述存储装置的多个姿态简档和多个相应能量设置；
(c)将所述取向传感器的输出与所述多个姿态简档中的第一姿态简档对比；
(d)将所述取向传感器的输出与所述多个姿态简档中的第二姿态简档对比；
(e)基于将所述取向传感器的输出与所述第一姿态简档和所述第二姿态简档对比的步骤来确定装置姿态；以及
(f)基于所述装置姿态来选择相应能量设置。
21.一种设备，所述设备包括：
(a)能量部件，所述能量部件能够在多个能量设置下操作；
(b)端部执行器，其中所述端部执行器联接到所述能量部件，其中所述能量部件能够操作以启动所述端部执行器的至少一部分；
(c)与所述能量部件相联的功率源，其中所述功率源能够操作以在所述多个能量设置下驱动所述能量部件；和
(d)存储装置，其中所述存储装置包括控制设置，其中所述功率源能够操作以根据所述存储装置的控制设置在所述一个或多个能量设置下驱动所述能量部件，其中所述存储装置能够基于预定义的设计寿命到期而减少能够由所述能量部件获得的控制设置。
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BR112014030047A2 (pt) 2017-06-27

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