CN104244850B - 具有组织密度感测的外科器械 - Google Patents
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- A61B2017/320089—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic node location
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- 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
- A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
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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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- 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
- A61B2017/320097—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 stapling means
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- A61B90/06—Measuring instruments not otherwise provided for
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Abstract
本发明公开一种设备,该设备包括端部执行器、主体组件、功率源和控制模块。该端部执行器可操作以用于外科手术并且能够向手术部位传送能量。该端部执行器包括至少一个传感器。该传感器能够测量与手术部位相关的至少一个物理特性。该主体组件与端部执行器相联。功率源与主体组件相联并且可操作以向端部执行器传送功率。该控制模块与传感器相联并且可操作以基于来自传感器的指示组织密度改变的数据来改变向端部执行器传送的功率。
Description
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/基因治疗传送装置以及使用超声、射频、激光等的能量传送装置。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,从而利于将端部执行器定位在患者体内。
内窥镜式外科器械的例子包括公开于下述专利中的那些: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 andBlade”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;2011年1月20日公布的名称为“RotatingTransducer 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;2002年12月31日公布的名称为“Electrosurgical Systems 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;以及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,这些外科工具可包括无线换能器,例如公开于2009年6月4日公布的名称为“CordlessHand-held Ultrasonic Cautery Cutting Device”的美国专利公布2009/0143797中的无线操作,其公开内容以引用方式并入本文。另外,外科器械可用于或可适用于机器人辅助的外科装置,例如公开于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中的机器人辅助外科装置,其公开内容以引用方式并入本文。
虽然已制造并使用了多种外科器械,但是据信,在本发明人之前还无人研制出或使用如本文所描述的发明。
附图说明
虽然在说明书之后提供了特别指出和清楚地要求保护本发明的权利要求书,但是据信通过对下面某些实施例的描述并结合附图可以更好地理解本发明,附图中类似的附图标记表示相同元件,其中:
图1示出了示例性外科器械的方框图;
图2示出了示例性超声外科器械的透视图;
图3示出了示例性外科器械的方框图;
图4示出了使用图3的外科器械的示例性方法的流程图;
图5示出了使用图3的外科器械的替代形式的示例性方法的流程图;
图6示出了使用图3的外科器械的另一种替代形式的示例性方法的流程图;
图7示出了使用图3的外科器械的又一种替代形式的示例性方法的流程图;
图8示出了使用图3的外科器械的再一种替代形式的示例性方法的流程图;
图9示出了使用图3的外科器械的再一种替代形式的示例性方法的流程图;并且
图10示出了使用图3的外科器械的再一种替代形式的示例性方法的流程图;
附图并非意在以任何方式进行限制,并且可以预期本发明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。附图并入本说明书中并形成其一部分,示出了本发明的若干方面,并与说明书一起用于解释本发明的原理;然而,应当理解,本发明并不限于所示出的精确安排。
具体实施方式
对本发明的某些例子的如下描述不应用来限制本发明的范围。通过以下举例说明设想用于实施本发明的最佳方式之一的描述,本领域的技术人员将显而易见本发明的其它例子、结构、方面、实施例和优点。正如将会意识到的,本发明可以是其它不同且明显的方面,只要不脱离本发明即可。例如,尽管各种。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。
还应当理解,本文所述的教导内容、表达方式、实施例、实例等中的任何一个或多个可与本文所述的其它教导内容、表达方式、实施例、实例等中的任何一个或多个相结合。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。此类修改形式以及变型旨在包括在权利要求书的范围内。
I.示例性外科器械的概述
图1以图解方块图的形式示出了示例性医疗装置和/或外科器械10的部件。如图所示,医疗装置10包括控制模块12、功率源14和端部执行器16。仅示例性的功率源14可包括镍氢电池、锂离子电池(例如,棱柱状电池型锂离子电池等)、镍铬电池或者任何其它类型的功率源,按照本文的教导内容,这对本领域技术人员而言可能是显而易见的。控制模块12可包括微处理器、专用集成电路(ASIC)、存储器、印刷电路板(PCB)、存储装置(诸如固态驱动器或硬盘)、固件、软件或者任何其它合适的控制模块组件,按照本文的教导内容,这对于本领域的普通技术人员而言将是显而易见的。控制模块12和功率源14通过诸如缆线和/或电路板中的迹线等的电连接件22联接,以将功率从功率源14传送到控制模块12。作为另外一种选择,功率源14可选择性地联接到控制模块12。这允许功率源14从医疗装置10分离和移除,其可进一步允许功率源14容易地进行再充电或回收以用于重新消毒和再利用。除此之外或者可替代的是,控制模块12可被移除以用于维护、测试、替换或其它目的,根据本文的教导内容,这对于本领域的普通技术人员而言将是显而易见的。控制模块12还可操作以通过使用功率源14来提供脉冲能量,如将在下文进一步讨论的。
端部执行器16通过另一个电连接件22联接到控制模块12。端部执行器16能够执行医疗装置10的期望功能。仅以举例的方式,这样的功能可以包括烧灼组织、消融组织、切割组织、超声振动、缝合组织或者用于医疗装置10的任何其它期望的任务。从而,端部执行器16可以包括主动结构,例如超声刀、一对夹紧钳口、尖锐小刀、缝合驱动组件、单级RF电极、一对双极RF电极、加热元件和/或各种其它组件。端部执行器16还能够从医疗装置10移除,以用于维护、测试、替换或任何其它目的,参考本文的教导内容,这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,端部执行器16是模块化的,使得医疗装置10可以与不同类型的端部执行器一起使用(例如,如序列号为61/410,603的美国临时申请所教导的等)。根据医疗装置10的目的,可提供端部执行器16的各种其它构型以用于各种不同的功能;根据本文的教导内容,这对于本领域的普通技术人员而言将是显而易见的。相似地,根据本文的教导内容,能够从功率源14接收功率的其它类型的医疗装置10的组件对本领域技术人员而言将是显而易见的。
本例子的医疗装置10包括触发器18和传感器20,但是应当理解,这样的组件仅仅是任选的。触发器18通过电连接件22联接到控制模块12和功率源14。触发器18能够选择性地将功率从功率源14提供到端部执行器16(和/或到医疗装置10的一些其它组件),以在执行手术时激活医疗装置10。传感器20也通过电连接件22联接到控制模块12并且也许能够在手术期间向控制模块12提供多种信息。仅以举例的方式,此类构型可包括感测端部执行器16处的温度或确定端部执行器16的摆动速率。来自传感器20的数据可通过控制模块12处理,以实现功率到端部执行器16的传送(例如在反馈回路等中)。根据医疗装置10的目的,可提供传感器20的各种其它构型;根据本文的教导内容,这对于本领域的普通技术人员而言将是显而易见的。当然,和本文所述的其它组件一样,医疗装置10可以具有不止一个传感器20,或者如果需要传感器20可以简单地被省略。下文将讨论关于传感器20的进一步的细节及其变型。
II.示例性超声外科器械
图2示出了外科系统11,该外科系统11包括上文所述的器械10的示例性超声型式50。当器械50的超声部件为非活动时,可根据需要容易地夹持和操纵组织,而不进行组织切割。当超声部件被启动时,器械50允许组织被端部执行器80抓持用于与超声能量耦联,以进行组织凝固,并施加增加的压力,从而有效地进行组织切割和凝固。如果需要,可以在不使用端部执行器80的夹持机构的情况下,通过适当操纵超声刀82来将超声能量施加到组织。
仅以举例的方式,外科系统11能够根据任何合适的教导内容或者来自以下专利中的任意一个的教导内容的组合被构造并且/或者操作: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 anUltrasonic Surgical Instrument”的美国公布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 andCoagulating”的美国公布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 Cuttingand Coagulating”的美国公布2008/0200940,其公开内容以引用方式并入本文;2009年6月4日公布的名称为“Cordless Hand-held Ultrasonic Cautery 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;2009年8月20日公布的名称为“Motorized Surgical Cutting and Fastening Instrument Having Handle BasedPower Source”的美国公布2009/0209990,其公开内容以引用方式并入本文;2010年3月18日公布的名称为“Ultrasonic Device for Fingertip Control”的美国公布2010/0069940,其公开内容以引用方式并入本文;以及2011年1月20日公布的名称为“RotatingTransducer Mount for Ultrasonic Surgical Instruments”的美国专利公布2011/0015660的图1中,其公开内容以引用方式并入本文。类似地,医疗装置能够包括便携式功率源的若干方式公开于2010年11月5日提交的名称为“Energy-Based SurgicalInstruments”的美国临时专利申请序列号61/410,603中,其公开内容以引用方式并入本文。
示例性超声外科系统11包括超声外科器械50、发生器21和缆线30,该缆线可操作以将发生器21联接到外科器械50。合适的发生器21为由Ethicon Endo-Surgery,Inc.(Cincinnati,Ohio)出售的GEN 300。仅以举例的方式,发生器21可根据2011年4月14日公布的名称为“Surgical Generator for Ultrasonic and Electrosurgical Devices”的美国公布2011/0087212的教导内容进行构造,其公开内容以引用方式并入本文。应该指出的是,将参照超声外科器械来描述外科器械50;然而,如根据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/基因治疗传送装置、以及使用超声、射频、激光等的能量传送装置、和/或它们的任何组合。此外,尽管本实例将参照缆线连接的外科器械50进行描述,但应当理解,外科器械50可适于无线操作,例如公开于美国专利公布2009/0143797。此外,外科装置50还可以用于或适于用于例如美国专利6,783,524中所公开的机器人辅助的外科装置。
本实例的外科器械50包括多部件柄部组件60、细长的传输组件70、和换能器100。传输组件70在传输组件70的近端处联接至多部件柄部组件60并且从多部件柄部组件60向远侧延伸。在本例子中,传输组件70能够为细长的、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70可为短组件,例如美国专利公布2007/0282333和美国专利公布2008/0200940中所公开的。本例子的传输组件70包括外部护套72、内部管状致动构件(未示出)、波导(未示出)、以及位于传输组件70远端的端部执行器80。在本例子中,端部执行器80包括联接至波导的刀82、可操作以在传输组件70的近端处枢转的夹持臂84、以及任选的可联接至夹持臂84的一个或多个夹持垫86。还应当理解,夹持臂84以及相关的结构可根据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的教导内容中的至少一些进行构造和操作,其公开内容以引用方式并入本文。还应当理解,端部执行器80的一些型式可以不具有夹持臂84。例如,端部执行器80可以仅仅包括刀82。能够将超声能量从换能器100传播到刀82的波导可以为柔性、半柔性或刚性的。一种仅为示例性的超声换能器100为由位于Cincinnati,Ohio的Ethicon Endo-Surgery公司出售的型号HP054。如本领域中所熟知,波导也能够为将通过波导传播到刀82的机械振动放大。波导还可具有用于控制沿波导的纵向振动的增益的结构,并且具有用于将波导调谐至系统共振频率的结构。
在这个例子中,刀82的远端设置在波腹附近,以便在声学组件未被组织承载时将声学组件调谐至优选的共振频率fo。当换能器100通电时,刀82的远端能够在例如大约10至500微米峰间范围内、并且优选地在约20至约200微米的范围内以例如55.5kHz的预先确定的振动频率fo纵向运动。当本例子的换能器100激活时,这些机械振荡通过波导被传播到端部执行器80。在本例子中,耦合到波导的刀82在超声频率下振荡。因此,当将组织固定在刀82和夹持臂84之间时,刀82的超声振荡可同时切割组织并且使相邻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82和夹持臂84提供电流以另外烧灼组织。尽管已描述出传输组件70和换能器100的一些构型,但根据本文的教导内容,传输组件70和换能器100的其他合适构型对于本领域的普通技术人员而言将是显而易见的。
本例子的多部件柄部组件60包括配对外壳部分62和下部64。配对外壳部分62能够在配对外壳部分62的近端接纳换能器100并且在配对外壳部分62的远端接纳传输组件70的近端。在配对外壳部分62的远端上设有孔以用于插入各种传输组件70。在本例子中示出了用于旋转传输组件70和/或换能器100的旋转旋钮66,但应当理解,旋转旋钮66仅为任选的。多部件柄部组件60的下部64包括触发器68并且能够供使用者单手抓紧。下部64的一个仅为示例性的替代构造示于美国专利公布2011/0015660的图1中。触发按钮(未示出)可位于下部64的远侧表面上,并且可操作以利用发生器21以不同操作水平激活换能器100。例如,第一触发按钮可激活最大能量水平下的换能器100而第二触发按钮可激活最小、非零能量水平下的换能器100。当然,根据本文的教导内容对于本领域普通技术人员来说显而易见的是,触发按钮可能够用于除最大和/或最小能量水平之外的能量水平。此外,触发按钮可位于多部件柄部组件60上、换能器100上、和/或远离外科器械50的任何其它位置,并且可提供任意数量的触发按钮。尽管已参照两个不同部分62,64来描述多部件柄部组件60,但应当理解,多部件柄部组件60可为两个部分62,64结合在一起的一体组件。作为另外一种选择,多部件柄部组件60可分成多个分立元件,例如单独的触发器部分(可通过用户的手或脚来操作)和单独的配对外壳部分62。触发器部分可操作以启动换能器100并且可远离配对外壳部分62。如根据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60可由耐用塑料(例如聚碳酸酯或液晶聚合物)、陶瓷、和/或金属、或者任何其他合适的材料进行构造。根据本文的教导内容,多部件柄部组件60的其他构型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50可作为机器人系统的一部分进行操作。根据本文的教导内容,多部件柄部组件60的其它构造对于本领域的普通技术人员也将是显而易见的。
根据本文的教导内容,系统11可以采用的进一步其它合适的形式对于本领域的普通技术人员而言将是显而易见的。
III.具有声学感测的示例性外科器械
应当领会,在使用外科器械50时,外科器械50可能遇到密度不同的组织。例如,当在肌肉、骨、脂肪、疤痕组织、或任何其它类型的组织之间过渡时,外科器械50可能遇到不同的密度。当在组织中使用外科器械50期间,可能期望了解外科器械50何时遇到组织密度的改变。在一些情况下,了解遇到了不同的组织密度是足够的。还可能期望了解不同类型的组织的性质。此外,在一些情况下,应当领会,一旦到达不同的组织密度,就可能期望使外科器械50自动改变其行为。除此之外或可替代地,可以通过一些方式通知使用者外科器械50正在接近不同类型的组织或者与该不同类型的组织相接触,这时使用者可以决定手动改变他/她对外科器械50的操作。
图3示出了示例性外科器械200的示意图,该外科器械200具有手动件202,该手动件202与端部执行器204相联。应当理解,外科器械200是上文所述的外科器械10,50的变型。端部执行器204与手动件202选择性地相联,但是应当理解,在一些型式中,端部执行器204可以与手动件202整体形成。根据本文的教导内容,可使用其它合适的构型对于本领域的普通技术人员而言将是显而易见的。端部执行器204包括多个部件,其中包括至少一个传声器210、至少一个传感器212、和至少一个加速度计208。当然,端部执行器204可以包括多个其它部件,其中包括但不限于超声刀、夹持臂、电外科特征、缝钉施布组件等。在端部执行器204包括超声刀的型式中,端部执行器可能不具有夹持构件。例如,端部执行器204可根据美国专利公布2008/0200940的教导内容中的至少一些进行构造,其公开内容以引用方式并入本文。考虑到本文的教导内容,仅具有刀的端部执行器204可以采用的其它合适的形式对于本领域的普通技术人员而言将是显而易见的。在包括超声刀和夹持构件的端部执行器204的型式中,端部执行器204可以根据美国专利公布2007/0191713、美国专利公布2007/0282333、和美国专利公布2006/0079874的教导内容中的至少一些进行构造,所述专利公布中的每一个的公开内容以引用方式并入本文。根据本文的教导内容,端部执行器204可以采用其它合适的形式对于本领域的普通技术人员而言将是显而易见的。
尽管本例子的端部执行器204包括传声器210、传感器212、和加速度计208,但是应当理解,端部执行器204不必包含传声器210、传感器212、和加速度计208中的每一个。此外,尽管图3将传声器210、传感器212、和加速度计208示为与端部执行器204分开,但是应当理解,传声器210、传感器212、和加速度计208中的任何一个或全部可以集成到端部执行器204中,或者作为供选择的替代方案可以与端部执行器204一体地构造。应当理解,传声器210和/或加速度计208能够定位在手动件202中。例如,传声器210能够定位成使得传声器210可操作以在手动件202中的谐波波导的近端处监测声学信号。同样,加速度计208可以定位在手动件202中,以在外科器械200移动穿过组织时监测手动件202的运动。根据本文的教导内容,可利用其它合适的变型对于本领域的普通技术人员而言将是显而易见的。
传声器210可总体操作以起到声学传感器的作用。应当理解,传声器210可操作以在超声频率、听觉频率、和/或次声频下检测声学信号。传声器210与计算模块214相联,将在下文对该计算模块214进行进一步的讨论,该计算模块214可操作以检测和记录可能出现在传声器210周围的任何东西的声音样本。例如,应当理解,当使用外科器械200时,外科器械200的部件可能产生能够指示与将与外科器械200相接触的组织的性质和/或密度相关的信息的各种声学信号或者脉冲。这些声学信号或脉冲可能在产生各种声学信号或脉冲之间被传声器210接收到;并且/或者可以由备选的传声器接收到。在外科器械200引导端部执行器204穿过密度不同的组织的情况下可能存在的一个例子中,外科器械200可以基于各种阻尼水平或者测量到的由组织造成的信号强度的损失来产生不同的声学信号。传声器210能够定位以在与端部执行器204相联的刀或波导处监测声学信号。超声刀所遇到的组织的类型/密度可能改变与包括刀的声学组件相关的声学信号特性。这种改变可能发生在超声频率、听觉频率、和/或次声频下。因此,可以基于所监测到的声学信号得出对组织密度和/或类型的推断,由此可以向使用者提供关于受外科器械200影响的组织类型的信息。
如上所述,传声器210可操作以在各种特定频率(例如,超声频率、听觉频率、和/或次声频等)下监测声音。例如,传声器210能够结合各种过滤器、放大器等使用,以关注出现在特定频率下的信号,从而避免可能不提供关于外科器械200的有用信息的一些声学信号。能够对传声器信号应用快速傅立叶变换(FFT)或者其它类似的计算法,以交互操作从换能器/刀共振结构发射的一个或多个频率。这些频率的改变能够用作模态耦合的替代物并且因此用作检测不期望的振动状态或模式的方式。一旦被检测到,这能够用作反馈的方式以警示使用者,通过改变驱动信号特性来改变共振系统的行为,或者同时警示使用者并且通过改变驱动信号特性来改变共振系统的行为。根据本文的教导内容,一个或多个传声器210可以用于检测组织密度和/或组织密度的改变的进一步其它合适的方式对于本领域的普通技术人员而言将是显而易见的。
此外,如根据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,传感器212可以包括阻抗传感器、温度传感器、力传感器、和/或任何其它合适类型的传感器。在传感器212包括阻抗传感器的型式中,传感器212可以用于感测与端部执行器204相接触的组织的阻抗。端部执行器204所遇到的组织的阻抗可以基于这种组织的密度发生变化。例如,与密度较低的组织(例如,脂肪组织)所表现出的阻抗相比,相对致密的组织(例如,疤痕组织)可能表现出相对较高的阻抗。因此,传感器212可以用于检测作为阻抗的函数的组织密度的改变。应当理解,这种阻抗可以包括电阻抗和/或声学阻抗。例如,相对致密的组织可以同时表现出相对较高的电阻抗和相对较高的声学阻抗。还应当理解,可以通过不同的方式来测量阻抗。仅以举例的方式,模拟电路可以用于通过产生两个与电压和电流振幅成比例的两个电压来测量平均电阻抗(例如,rms、峰间、或简单平均值)并且随后除以这些电压以提供与电阻抗成比例的模拟电压输出。作为另一个仅仅是说明性的例子,可以通过数字并且瞬时读取和计算电阻抗。具体而言,系统可以读取实际瞬时电压和实际瞬时电流;随后相除这些数值以计算瞬时阻抗。根据本文的教导内容,电阻抗传感器可以实施成传感器212的各种合适的方式对于本领域的普通技术人员而言将是显而易见的。类似地,根据本文的教导内容,声学阻抗传感器可以实施成传感器212的各种合适的方式对于本领域的普通技术人员而言将是显而易见的。
作为另一个仅仅是说明性的例子,不同的组织密度可以对端部执行器204做出不同的热反应。因此,在传感器212包括温度传感器的型式中,传感器212可以用于检测作为温度的函数的组织密度的改变。在传感器212包括力传感器(例如,应变仪等)的型式中,传感器212可以用于检测作为当端部执行器204挤压组织时端部执行器204所遇到的力/应变的函数的组织密度的改变。根据本文的教导内容,可以用于检测组织密度和/或组织密度的改变的进一步其它合适类型的传感器212对于本领域的普通技术人员而言将是显而易见的。
加速度计208可操作以检测端部执行器204的运动。应当理解,从加速度计208收集到的信息可以用于确定使端部执行器204运动的力。还应当理解,可以确定与端部执行器204的运动相关的单纯的速度、相对速度、平均速度、变化率、或者任何其它合适的度量标准。当端部执行器204遇到相对致密的组织时,这可能造成端部执行器204沿其运动路径减速,并且加速度计208能够检测到该减速。类似地,端部执行器204可以在沿其行进路径从致密组织过渡到密度相对较小的组织时经历加速,加速度计208能够检测到该加速。计算模块214还能够区分基于组织密度改变的加速/减速与基于外科医生的手部运动改变加速/减速。例如,计算模块214能够比较来自加速度计208的数据与来自一些其它类型的传感器(例如,柄部组件202中的应变仪等)的数据,以辨别基于组织密度改变的加速/减速与基于外科医生的手部运动改变的加速/减速。根据本文的教导内容,一个或多个加速度计208可以用于检测组织密度和/或组织密度的改变的进一步其它合适的方式对于本领域的普通技术人员而言将是显而易见的。
功率源206也与柄部组件202相联并且可操作以向端部执行器204传送功率。尽管图示的型式将功率源206示为与柄部组件204分开,但是功率源206可以集成到柄部组件204中。
此外,外科器械200包括与端部执行器204相联的计算模块214、功率源206、加速度计208、传声器210、和传感器212。计算模块214可以包括任何合适的部件,所述任何合适的部件可以包括处理器、存储器、或者如根据本文的教导内容对于本领域的普通技术人员而言将显而易见的任何其它合适的与计算相关的部件。计算模块214可操作以执行或运行与外科器械200的部件中的任何部件的操作相关的程序或算法。例如,计算模块214可操作以控制端部执行器204的步骤或者传声器210、传感器212、和加速度计208的步骤。此外,计算模块214可以通过柄部组件204与功率源206相联,使得计算模块214可操作以控制或利用功率源206来执行计算模块214的任何合适的例行程序和/或程序。因此,计算模块214可操作以执行控制逻辑。
尽管计算模块214被示为定位在柄部组件202内,但是应当理解,计算模块214可以定位在任何合适的位置处。例如,计算模块214可以定位在端部执行器204中、功率源206中、并且/或者甚至可以被容纳在定位于柄部组件202与功率源206之间的模块内。在进一步其它的示例性型式中,应当理解,计算模块214不必限于单个计算模块214。计算模块214可以能够使得使用多个计算模块214,其中所述多个计算模块214可以定位在单一位置处或者遍布外科器械200或者甚至远程地定位。
如上所述,端部执行器204包括传声器210、传感器212、和加速度计208。还应当理解,在外科手术中使用端部执行器204可能涉及通过端部执行器204向手术部位提供超声振动。还应当理解,向手术部位传送超声振动造成由端部执行器204产生音调或音高。例如,应当理解,如果由超声刀(例如,像上文所述的刀82)从端部执行器204传送振动,则当端部执行器204的刀行进穿过不同类型的组织密度时,来自端部执行器204的振动将由于振动以不同的速度行进穿过密度不同的组织而产生声学特性不同的声音。因此,还应当理解,不仅穿过不同组织的振动所产生的声音不同,传声器210可操作以在振动被传送到密度不同的组织时检测声音的差异。这些声音的差异可能被刀82本身以及与刀82声学相联的部件和/或波导捕捉到。还应当理解,端部执行器204能够传送不同频率的振动并且传声器210可以在不同的频率下监测声学信号。例如,通过在不同的频率下监测声学信号,不同的数据是能够确定的。在一些情况下,组织密度的某些改变可能更明显或者能够在特定频率下被检测到。
IV.使用外科器械的示例性方法
图4示出了使用外科器械200的一个示例性方法。方框400涉及使用者启动外科器械200。应当理解,在一些型式中,外科器械200可以不必被启动—其可以默认处于“开”状态。
方框410包括开始声学监测。在一些型式中,外科器械200可以连续监测与该外科器械200的声学传动系(例如,超声换能器、喇叭、波导、和超声刀)相关的声学信号。应当理解,可以使用与计算模块214相联的传声器210来执行声学监测。传声器210连续检测与外科器械200的声学传动系相关的声音信号。计算模块214连续接收代表传声器210所捕获的声音信号的数据。应当理解,可以在计算模块214接收声学信号的同时使用计算模块214来执行声学监测。方框420涉及使用者在手术部位处使用外科器械200,通过端部执行器204操纵组织。在使用期间,方框430连续监测声学信号,以确定声学信号是否超过特定的预先确定的阈值,该特定的预先确定的阈值能够持续更新并且通过计算模块214计算出。
尽管本公开经常使用术语“阈值”,但是能够构想,该术语可以包括最小值或底线(floor)。换句话讲,如本文所使用的例如“超过阈值”的短语可以被理解成也涵盖数值下降到特定设定中的预先确定的最小值或底线以下的情况。因此,应当理解,在方框430监测以确定声学信号是否超过特定的预先确定的阈值的情况下,这可以包括监测声学信号是否下降到预先确定的最小值或底线以下。还将理解,声学信号的某种改变(例如,超过阈值)可以指示组织密度的改变,这可以指示组织类型的改变。因此,一旦在方框440中通知使用者该改变,使用者就能够停止使用外科器械200、继续使用外科器械200、或改变对外科器械200的使用。
存在可以执行图4中所示的方法的多种方式,其中包括可以执行方框430的多种方式。例如,一些型式的计算模块214以及端部执行器204的多个传感器210,212,208可操作以具有两种监测模式:横向监测模式和组织密度监测模式。在横向监测模式中,计算模块214可操作以对声学样本执行快速傅立叶变换,以识别其横向模式及相关频率。计算模块214还可操作以当端部执行器204未负载时,在将外科器械200用于组织上之前建立多个样本及其相关频率的基线模态间距(baseline modal spacing)。一旦外科手术中在使用外科器械200期间将负载施加到端部执行器204上,计算模块214就可操作以比较所识别出的横向模式与基线。最后,在外科手术中使用外科器械200期间所感测到的横向模式信号超过特定阈值或下降到底线以下的情况下,计算模块214可操作以停止与外科器械200相关的任何换能器的操作或者以其它方式使端部执行器204在至少一个时间周期期间至少部分地不可操作。
在组织密度监测模式中,计算模块214还可操作以对声学样本执行快速傅立叶变换,从而在不同的频率下识别其振幅。计算模块214还可操作以当端部执行器204未负载时,在将外科器械200用于组织上之前建立多个样本及其相关频率的基线振幅。一旦外科手术中在使用外科器械200期间将负载施加到端部执行器204上,计算模块214就可操作以比较在每一个频率下所感测到的振幅与预先建立的基线。最后,在测量到的频率的振幅下降到预先确定的范围以下的情况下,计算模块214可操作以表达端部执行器204正在遇到潜在的致密组织。例如,计算模块214可以联接到指示器,该指示器在视觉上和/或通过声音警示使用者已遇到致密组织。一旦振幅回到基线范围,那么计算模块214就可以向指示器通讯以停止警示使用者或为使用者产生不同的视觉和/或声音警示。除此之外或可替代地,计算模块214可以响应于组织密度的改变而影响端部执行器204的操作特性。当然,根据本文的教导内容,计算模块214的其它合适的用途和性能对于本领域的普通技术人员而言将是显而易见的。
图5示出了使用外科器械200的另一种示例性方法。应当理解,在一些情况下,外科器械200可以用于腹壁成形术、脂肪组织的体型塑造、和/或可能遇到疤痕组织或其它致密组织的一些其它的手术的应用中。应当理解,可能期望更多的电流以用于使用外科器械200,使得能够在使用者并未注意到外科器械200的性能改变的情况下切割疤痕组织。因此,方框500示出了外科器械200被启动。之后,方框510涉及开始监测组织阻抗和/或力。可以例如使用图3的传感器212来完成阻抗监测,该传感器212可以包括能够感测端部执行器204所遇到的组织的阻抗的阻抗传感器。此外,可以结合计算模块214使用加速度计208来测量力,以感测受端部执行器204挤压的组织所展现出的物理阻力的量。尽管图示的型式示出了所监测的组织阻抗和/或力,但是应当理解,可以除此之外或可替代地使用传声器210,以便监测外科器械200的声学信号。方框520随后示出了使用者在外科手术中使用外科器械200。在手术期间,方框530监测所感测到的阻抗和力,以确定阻抗或力是否超过任何特定的阈值(或下降到任何特定的底线以下)。在发生任一种的情况下,方框540引导外科器械200以通过使用功率源206来增大电流,由此通过更大的功率来驱动端部执行器204。
还应当理解,电流可以响应于由传声器210监测到的声学信号的改变而增大。例如,被高度阻尼的声学信号可以指示较致密的组织,外科器械200将通过电流增大对该信号做出响应。通过方框550产生反馈回路,其中方框550监测以确定阻抗和/或力是否在方框540中电流增大之后已下降到预先确定的阈值以下。因此,在端部执行器204遇到坚硬的疤痕组织的情况下,电流将继续增大,以便向外科医生提供流畅的切割体验。在阻抗水平、力水平、和/或声学信号再次下降到预先确定的阈值以下的情况下,方框560就使电流再次减小到先前在方框520处所使用的水平。
应当理解,选定的阈值可以取决于若干因素,其中包括但不限于换能器的组合以及所使用的端部执行器204的类型、使用者的使用习惯和熟练程度、所进行的外科手术的类型、以及患者与患者之间组织的不同。可以基于任何单一因素或因素的组合来建立初始阈值。在一些情况下,端部执行器的类型将是主要因素并且这可以用于阈值的初始设定。随后可以基于其它的因素来调节该初始阈值设定。例如,外科医生可以通过姓名以及/或者通过输入特定于其器械使用简介的代码来识别他自己/她自己的身份。还应当理解,系统可以是学习系统,其中阈值开始于特定的初始设定并且在外科医生使用该系统时被调节。在一些这种情况下,外科医生可以从相对较为容易的组织开始(例如,提供低于阈值的数据值),随后随着手术进行过渡到较为坚硬的组织。器械200的该早期使用可以用于在手术早期有效地为阈值设定基线并且随后允许阈值根据预先确定的最大和最小的范围限制向上/向下调节。根据本文的教导内容,可建立阈值的其它合适的方式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,在例如外科器械200用于从骨移除组织的应用的场景中,可能期望避免在移除软组织的过程中由于疏忽而切割骨。因此,与响应于如图5中所示的组织密度改变而增大电流相反,电流可以取而代之地减小。为此,图6的方框600示出了外科器械200被启动。方框610示出了开始监测阻抗和力。例如,加速度计208可以用于检测端部执行器204穿过组织的运动的减慢或停止。传感器212还可以包括用于监测端部执行器204所遇到的组织的阻抗的阻抗传感器。除此之外或可替代地,方框610能够用于监测外科器械200的声学信号,以确定是否应当减小被提供给外科器械200的电流。在方框620中,使用者使用外科器械200。方框630示出了检查和连续监测阻抗和/或力测量结果,以确定是否超过任何预先确定的阈值(或者下降到任何特定的底线以下)。除此之外或可替代地,方框630还可以监测声学信号。在超过阈值的情况下,可以指示外科器械200遇到骨组织。因此,在方框640中,由功率源206提供给外科器械200的电流减小,由此减少或停止端部执行器204处的功率。通过方框650形成反馈回路,其中方框650连续监测以确定阻抗、力、和/或声学测量结果是否已再次下降到预先确定的阈值以下。如果不是这样,则指示骨组织可能仍然在附近,因此需要较少的电流来驱动端部执行器204。一旦确定阻抗、力、和/或声学测量结果已下降到阈值量以下,则方框660引导外科器械200使电流再次增大到先前在方框620处所使用的水平。
在一些情况下,应当理解,与将外科器械200调节成所感测到的组织环境相反,可能期望使外科器械200简单地通知使用者,使得使用者能够调节对外科器械200的使用。例如,图7示出了其中外科器械被启动的方框700。之后,方框710指示组织阻抗监测开始。例如,可以通过图3中所示的传感器212来完成组织阻抗监测。应当理解,除此之外或可替代地,通过传声器210检测到的声学信号和/或通过加速度计208检测到的运动也可以被监测。之后,使用者可以开始切割,如方框720中所示。方框730连续监测由传感器212检测到的组织阻抗、力、和/或声学信号。在阻抗、端部执行器204的运动、和/或声学信号发生快速改变时,方框740警示使用者。这种警示可以包括声音警示、视觉警示、或者如根据本文的教导内容对于本领域的普通技术人员而言将显而易见的任何其它合适的警示。警示(声音、视觉等)可以集成到手持件202中或者甚至功率源206中,使得使用者可以通过注意到出现在手持件202上的警示而被警示。除此之外或可替代地,警示装置能够从以下位置被注意到:功率源206或者使用者可视觉感知的任何其它合适的位置或者使用者的听觉范围内(如果警示装置包括声音警示的话)。在方框750中,使用者随后可以警示外科器械200的运动或定位并且之后继续切割组织,如方框760中所示。例如,使用者可以在往复的“弓形锯运动(hacksaw motion)”中移动端部执行器204,以便更有效地横切致密组织。当使用者移动端部执行器204穿过致密组织时,一旦组织变为密度较小,就可以向使用者提供警示,指示致密组织的区域已通过。因此,使用者可以在往复的“弓形锯运动”之前重新使用用于移动端部执行器204的运动。如根据本文的教导内容,本领域的普通技术人员将显而易见的是,在可供选择的替代方案中,使用者可以将他或她对端部执行器204的移动改变成任何合适的运动。
应当理解,在一些型式中,在管理电流的方式中,可能需要外科器械200更加柔性。与仅仅增大电流或减小电流相反,可能期望以外科器械200能够基于端部执行器204所接合的组织密度或者组织密度的改变智能地确定是否需要来增大电流或减小电流的方式来使用外科器械200。例如,在图8中,方框800涉及启动外科器械200。方框810开始能量脉动以及使用外科器械200。在超声外科器械50的情况下,外科器械50可以通过刀82向手术部位传送超声振动。这种振动可以通过将电功率脉动到外科器械50的换能器而产生。在一些型式中,启动脉冲以处于从一个脉冲每10毫秒至一个脉冲每100毫秒的范围内的频率被传送到换能器100。当然,根据本文的教导内容,对于本领域的普通技术人员将而言显而易见的是,可使用任何其它合适的脉冲频率。这些启动脉冲造成换能器100中的压电元件将电功率转化成机械振荡/振动功率,形成沿声学波导连通到超声刀82的超声振荡。在被传送给换能器100以产生超声振动的电启动脉冲之间,外科器械50向传感器212提供电压,以检测相邻的组织的阻抗。在如方框830中所示的检测到高阻抗的情况下,电流可以如方框860中所示的在下一个功率传送脉冲中增大,以便有助于外科器械200在手术部位处切入相对致密的组织。在如方框840中所示的检测到低阻抗的情况下,在下一个功率传送脉冲中被传送到外科器械200的电流可以如方框850所示的被保持或降低。应当理解,所保持的电流水平可以为大约250mA或者如根据本文的教导内容对于本领域的普通技术人员而言将显而易见的任何其它合适的电流水平。
在一些情况下,可能期望确定手术组织定位在脂肪组织还是肌肉组织中。应当理解,外科器械200的声学传动系(例如,超声换能器、喇叭、波导、和超声刀)可以基于端部执行器204与例如脂肪组织的组织还是将更大的声学负载施加在端部执行器204上的例如肌肉的相对较致密的组织相接触而表现出不同的谐振频率。例如,当端部执行器204挤压脂肪组织时,例如脂肪组织的低负载可以在声学传动系的谐振频率中提供相对较小的偏移。例如肌肉或软骨的较致密的组织可以相对于端部执行器204提供较高的机械/声学负载,导致声学传动系的谐振频率相对较大。这些效果甚至可能在端部执行器204被用作刀而不是剪刀时更明显。当端部执行器204被用作刀时,使用者可以基于所选择的组织类型以及作为刀的端部执行器204施加在组织上的压力的量来确定有效的负载。施加的力或压力越高,声学负载就越高并且谐振频率的偏移就越大。当端部执行器204被用作剪刀时(例如,通过像夹持臂84等的夹持特征的步骤),压力分布可能较少地取决于夹持特征与超声刀之间的组织的量/类型。这使得使用者能够更多地关注将横切哪个组织并且较少地关注施加于各种类型的组织的力的细微差别。在一些这种型式中,使用者可以通过将超声刀刃抬起到组织中来实现较快的处理次数,其中力传感器212提供在端部执行器204处对超声刀与夹持构件之间的压力的测量。
处理谐振频率的改变的例子示于图9中。方框900示出了启动外科器械200。方框910示出了确定谐振频率Fn,然后将初始频率设定成Fn_start,如方框920中所示。这建立了用于与稍后检测到的谐振频率比较的基线谐振频率。应当理解,这种基线谐振频率(Fn_start)可以通过在将端部执行器204施加到组织上之前启动端部执行器204的超声刀、以及通过传感器212在端部执行器2040处感测力来获得。使用者随后可以切割组织,如方框930中所示。当组织被切割时,传感器212继续监测谐振频率(Fn),如方框940中所示。当更新Fn时,Fn相对于Fn_start的改变率被监测,以捕捉谐振频率的偏移。在观察到较慢的Fn的改变率的情况下,则能够推断出外科器械200处于肌肉组织中。使用者可能希望了解肌肉组织的存在,因此方框990向使用者提供反馈,该反馈可以呈可听音、振动、如根据本文的教导内容对于本领域的普通技术人员而言将显而易见的任何其它合适的反馈方式的型式。之后,被提供给外科器械200的电流响应于所感测到的组织密度增大而如方框995中所示的手动或自动地增大,以通过更多能量来驱动端部执行器204从而横切相对致密的组织。在Fn的改变率如方框960中所示的快时,能够推断外科器械200处于脂肪组织中。因此,电流可以如方框980中所示的手动或自动地减小,以通过较少的能量来驱动端部执行器204从而横切相对柔软的组织。
还应当理解,在一些情况下,可能期望使外科器械200可操作以同时监测若干不同的特性,其中包括力改变、功率/阻抗改变、谐振频率改变、和/或运动改变,以确定被切割的组织的密度是否改变。图10示出了这种系统并且通过使用者启动外科器械200的方框1000开始。使用者随后使用外科器械200来切割组织,如方框1010中所示。当使用外科器械200时,力、加速度、功率、阻抗、以及声学信号水平和曲线被连续监测,如方框1020中所示。之后,可以检测到如方框1030中所示的力的任何增大。此外,可以检测到如方框1040中所示的功率的增大,并且也可以检测到如方框1050中所示的运动的任何减少。因此,可以相应地调节电流和/或功率(增大或减小),如方框1060中所示。例如,方框1060和/或方框1070可以基于离散的数值和/或趋势、基于在方框1030,1040,1050中的任何一个中出现并且被检测到的数值和/或趋势的各种组合。应当理解,阻抗数值/趋势和声学信号的特定组合可以指示特定的组织密度特性。同样,特定的加速度计数值和声学信号的组合可以指示另一种组织密度特性。应当理解,阻抗、声学信号、和/或加速度计读数的各种组合可以用于指示组织密度的特性,这可以被编程或者通过其它方式集成到计算模块214中。随后相应地,计算模块214可操作以在方框1060,1070处提供相应的指令和/或命令,以使得端部执行器204能够继续横贯组织。
外科器械200还可操作以基于方框1030,1040,1050中的监测来具体识别组织类型并且相应地警示使用者。例如,可以基于声学、阻抗、和/或力信号的特定组合来通知使用者端部执行器204与骨相接合。信号的其它组合可以用于指示所接合的组织是脂肪组织、疤痕组织等。之后,可以将方框1070中所示的声音反馈提供给使用者,以通知使用者任何组织密度改变。还应当理解,可以除了或代替声音反馈之外使用例如视觉反馈、触觉反馈的其它的反馈机构、和/或端部执行器204控制改型,如根据本文的教导内容将对于本领域的普通技术人员而言显而易见的。此外,应当理解,所讨论的方法仅仅是示例性的并且可以使用其它合适的方法,如本领域的普通技术人员将显而易见的。
在穿过套管针或其它的进入端口使用外科器械200的一些情况下(例如,在微创手术中),外科器械200的轴可以关于患者体内的套管针的进入点以枢转方式运动。应当理解,患者体内的套管针的进入点因此可以起到运动的虚拟中心的作用。在柄部组件202处测量到的运动可以与相对支点(患者体内的器械200的长度/患者体外的器械200的长度)成比例。在端部执行器204处测量到的运动、力、加速度等可以与组织效果直接相关。定位在柄部组件202中的传感器可需要按比例绘制以反映枢轴-支点关系,以便准确地表示端部执行器204与组织的界面处所发生的情况。根据本文的教导内容,说明穿过套管针或其它的进入端口使用器械200的该方式以及其它合适的方式对于本领域的普通技术人员而言将是显而易见的。
V.其它方面
尽管上文的例子与呈超声器械形式的外科器械10相关,但是应当理解,本文的教导内容可以易于应用于各种类型的电外科器械,包括但不限于以下专利中所教导的电外科器械: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;2006年9月26日公布的名称为“Electrosurgical Instrument and Method of Use”的美国专利7,112,201,其公开内容以引用方式并入本文;2006年10月24日公布的名称为“ElectrosurgicalWorking End for Controlled Energy Delivery”的美国专利7,125,409,其公开内容以引用方式并入本文;2007年1月30日公布的名称为“Electrosurgical Probe and Method ofUse”的美国专利7,169,146,其公开内容以引用方式并入本文;2007年3月6日公布的名称为“Electrosurgical Jaw Structure for Controlled Energy Delivery”的美国专利7,186,253,其公开内容以引用方式并入本文;2007年3月13日公布的名称为“Electrosurgical Instrument”的美国专利7,189,233,其公开内容以引用方式并入本文;2007年5月22日公布的名称为“Surgical Sealing Surfaces and Methods of Use”的美国专利7,220,951,其公开内容以引用方式并入本文;2007年12月18日公布的名称为“PolymerCompositions Exhibiting a PTC Property and Methods of Fabrication”的美国专利7,309,849,其公开内容以引用方式并入本文;2007年12月25日公布的名称为“Electrosurgical Instrument and Method of Use”的美国专利7,311,709,其公开内容以引用方式并入本文;2008年4月8日公布的名称为“Electrosurgical Instrument andMethod of Use”的美国专利7,354,440,其公开内容以引用方式并入本文;2008年6月3日公布的名称为“Electrosurgical Instrument”的美国专利7,381,209,其公开内容以引用方式并入本文;2011年4月14日公布的名称为“Surgical Instrument Comprising First andSecond Drive Systems Actuatable by a Common Trigger Mechanism”的美国公布2011/0087218,其公开内容以引用方式并入本文;以及2011年6月2日提交的名称为“MotorDriven Electrosurgical Device with Mechanical and Electrical Feedback”的美国专利申请13/151,181,其公开内容以引用方式并入本文。
此外,本文的教导内容可以易于应用于各种类型的电动切割和缝合器械,包括但不限于以下专利中所教导的那些电动切割和缝合器械: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;2009年8月20日公布的名称为“Motorized Cutting and Fastening Instrument Having Control Circuit forOptimizing Battery Usage”的美国公布2009/0209979;以及2011年6月2日提交的名称为“Motor Driven Electrosurgical Device with Mechanical and Electrical Feedback”的美国专利申请13/151,181,其公开内容以引用方式并入本文。可应用本文的教导的进一步其它的合适类型的装置对于本领域的普通技术人员将是显而易见的。
应当理解,所述以引用的方式并入本文中的任何专利、出版物或其它公开材料,无论是全文或部分,仅在所并入的材料与本公开中给出的定义、陈述或者其它公开材料不冲突的范围内来并入本文。由此,在必要程度下,本文所明确阐述的公开内容将会取代以引用的方式并入本文中的任何相冲突的材料。如果据述以引用的方式并入本文但与本文所述现有定义、陈述或者其它公开材料相冲突的任何材料或其部分,仅在所并入的材料与现有公开材料之间不产生冲突的程度下并入本文。
本发明的一些型式可应用于常规的内窥镜式和开放性手术器械以及机器人辅助的手术。示例性的机器人辅助外科系统公开于2004年8月31日公布的名称为“RoboticSurgical Tool with Ultrasound Cauterizing and Cutting Instrument”的美国专利6,783,524中,其公开内容以引用方式并入本文。
本文所公开的装置的型式可设计为使用一次后丢弃,也可设计为供多次使用。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,可拆卸所述装置的型式,并且可选择性地以任何组合形式来更换或拆除所述装置的任意数量的特定部件或零件。清洗和/或更换具体零件后,所述装置的型式可在修复设施中进行重新组装以供随后使用,或者在即将进行外科手术前由外科手术团队进行重新组装。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。
仅以举例的方式,本文所述的型式可在外科手术之前进行处理。首先,可以获取新的或用过的器械,并且根据需要进行清洗。然后,可对器械进行消毒。在一种消毒技术中,装置放置在闭合并密封的容器、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。该密封容器可将器械保持在无菌状态,直到在外科设施中打开该容器。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。
在已经示出并描述了本发明的各种型式的情况下,本领域的普通技术人员可在不脱离本发明范围的前提下进行适当修改。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的而非所要求的。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以及操作细节。
Claims (15)
1.一种外科设备,包括:
(a)能够在外科手术中使用的端部执行器,其中所述端部执行器包括联接到声学传动系的超声刀,其中所述端部执行器能够借助于所述超声刀向手术部位处的组织传送超声能量,其中所述端部执行器包括至少一个传感器,所述至少一个传感器包括传声器,其中所述至少一个传感器能够通过采用传声器感测超声刀的与其相接触的组织的性质和/或密度相关联的信息的各种声学信号或者脉冲而获得由所述超声刀碰到的所述组织的类型或密度;
(b)与所述端部执行器相联的主体组件;
(c)与所述主体组件相联的功率源,其中所述功率源可操作以向所述端部执行器传送功率;以及
(d)与所述至少一个传感器相联的控制模块,其中所述控制模块可操作以基于来自指示组织密度改变的至少一个传感器的数据来改变向所述端部执行器传送的功率。
2.根据权利要求1所述的外科设备,其中所述传声器能够执行下列中的一个或多个:传播声音、接收声音、或测量声音。
3.根据权利要求2所述的外科设备,其中所述传声器能够感测与处于启动状态下的超声刀的独特模态耦合相关的超声振动、听觉振动、或次声振动。
4.根据权利要求1所述的外科设备,其中所述至少一个传感器包括阻抗传感器。
5.根据权利要求4所述的外科设备,其中所述阻抗传感器能够感测与组织相关的电阻抗。
6.根据权利要求1所述的外科设备,其中所述端部执行器可操作以基于由所述超声刀碰到的组织的密度来产生不同的声学信号。
7.根据权利要求1所述的外科设备,还包括与所述控制模块相联的听觉反馈装置。
8.根据权利要求1所述的外科设备,还包括与所述控制模块相联的触觉反馈装置。
9.根据权利要求1所述的外科设备,其中所述至少一个传感器包括加速度计。
10.根据权利要求1所述的外科设备,其中控制模块能够通知使用者所述至少一个传感器检测到的改变。
11.根据权利要求1所述的外科设备,其中所述至少一个传感器包括能够监测不同的物理属性的多个传感器。
12.根据权利要求1所述的外科设备,其中控制模块能够被编程以具有至少一个预定义的阈值参数。
13.根据权利要求1所述的外科设备,其中控制模块能够执行同步阻抗和力监测。
14.根据权利要求1所述的外科设备,其中控制模块能够响应于来自所述传感器的指示组织密度增加的数据而增加向所述端部执行器传送的功率。
15.根据权利要求1所述的外科设备,还包括声学传动系,其中所述超声刀与所述声学传动系相联,其中所述传感器可操作以感测与所述声学传动系相关的谐振频率,其中所述控制模块可操作以检测所述传感器检测到的谐振频率的偏移。
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US20130282038A1 (en) | 2013-10-24 |
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BR112014025798B1 (pt) | 2022-04-12 |
US9788851B2 (en) | 2017-10-17 |
WO2013158545A1 (en) | 2013-10-24 |
CN104244850A (zh) | 2014-12-24 |
EP2838447A1 (en) | 2015-02-25 |
US10653437B2 (en) | 2020-05-19 |
JP6271512B2 (ja) | 2018-01-31 |
US20180070976A1 (en) | 2018-03-15 |
IN2014DN08374A (zh) | 2015-05-08 |
JP2015515344A (ja) | 2015-05-28 |
CA2870536A1 (en) | 2013-10-24 |
AU2013249514B2 (en) | 2017-08-31 |
EP2838447B1 (en) | 2023-01-25 |
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