CN102068289A - 手术控制台和手持式手术器械 - Google Patents

手术控制台和手持式手术器械 Download PDF

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CN102068289A
CN102068289A CN2010105578077A CN201010557807A CN102068289A CN 102068289 A CN102068289 A CN 102068289A CN 2010105578077 A CN2010105578077 A CN 2010105578077A CN 201010557807 A CN201010557807 A CN 201010557807A CN 102068289 A CN102068289 A CN 102068289A
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唐纳德·马利诺思卡斯
戴维·A·泽伊奇勒
迈克尔·P·惠特曼
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Covidien LP
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
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    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis in a single operation
    • A61B17/1155Circular staplers comprising a plurality of staples
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    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/92Identification means for patients or instruments, e.g. tags coded with colour
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B90/00Instruments, 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
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • A61B90/98Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
    • AHUMAN NECESSITIES
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    • A61B2017/00115Electrical control of surgical instruments with audible or visual output
    • A61B2017/00119Electrical control of surgical instruments with audible or visual output alarm; indicating an abnormal situation
    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
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    • A61B2017/00464Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for use with different instruments
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Abstract

本发明提供了一种手术系统和方法,该手术系统包括被构造为无线发送专用于手术器械的识别数据的手术器械和被构造为接收识别数据的控制台。控制台被构造为基于识别数据注册手术器械,在手术器械与控制台之间建立无线双路通信链路,从手术器械接收运行数据和指令中的至少一个,并且基于运行数据和指令中的至少一个在手术器械的运行期间向手术器械的用户提供运行反馈数据。

Description

手术控制台和手持式手术器械
技术领域
本发明一般涉及一种手术控制台和一种手持式手术器械。
背景技术
例如,在美国公布的申请号为2009/0101692的专利申请中说明了一种电池供电的、手持式、整装式手术器械,并且在其中以附图标记800来表示,上述申请的全部以引用的方式专门地合并于此。该器械包括电路板,电路板响应来自例如外科医生的器械操作员的手动输入来控制各种功能,例如,关节式运动、转动以及钳夹的闭合和吻合切割机构的致动。由于不是物理地连接到任何外部驱动系统,这一器械在手术操作期间提供了可动性。
公认的是期望提供一种不降低或者基本不降低由例如上述手术器械的器械提供的可动性的双路通信装置。此外,公认的是期望注册一个以上手术器械并且保持注册的和/或未注册的器械的列表。
还公认的是期望提供一种用于跟踪与例如库存、器械和/或附加装置(attachment)或器械构件的使用次数、故障、清洁/消毒状态、和/或维修之间的使用次数相关的信息的机构。这种信息还可以包括由成像装置获取的图像和/或在既定手术操作中运行的器械控制的记录,例如,操作员使用什么输入或控制、什么时间使用和/或使用了多长时间、和/或最终的状态和/或例如电动机力、构件位置和/或从传感器获得的数据的参数的记录。而且,还期望基于接收到的信息向操作员提供视觉和/或听觉反馈。
而且,公认的是期望一种防止使用特定器械的系统,例如之前使用后尚未清洁的器械和/或未注册器械。
还公认的是期望提供一种为可以执行哪种手术操作提供可动性和灵活性的智能驱动单元。
发明内容
根据本发明的示例实施例,手术系统包括:手术器械,其被构造为无线发送专用于手术器械的识别数据;以及控制台,其被构造为接收识别数据。该控制台被进一步构造为基于识别数据注册手术器械,在手术器械和控制台之间建立无线双路通信链路,从手术器械接收运行数据和指令中的至少一个,以及基于运行数据和指令中的至少一个在手术器械的运行期间向手术器械的用户提供运行反馈数据。
控制台可以具有被构造为直观地显示反馈数据的至少一部分的显示屏。
所述显示屏可以为被构造为接收用户指令的触摸屏显示器。
所述控制台可以具有被构造为提供作为声音信号的反馈数据的至少一部分的扬声器。
所述反馈数据可以包括指示和询问中的至少一个。
反馈数据可以包括手术器械的运行参数。
根据权利要求1所述的手术系统,其中,手术器械被构造为当手术器械没有在控制台上注册时至少部分不能运行。
手术器械可以为手持式、电池供电的手术器械。
手持式、电池供电的手术器械可以包括被构造为容纳不同类型的手术附加装置的智能驱动单元。
不同类型的手术附加装置中的一个可以为手术切割器/吻合器。
控制台可以具有被构造为完成a)传达运行数据和b)接收用户指令中的至少一项的直观显示屏。
手术器械和控制台中的一个或两个可以被构造为如同在工业、科学以及医疗(ISM)无线电频带中的一个或多个中的FCC注册装置一样运行。
所述控制台可以被构造为向手术器械上载操作软件,手术器械被构造为执行操作软件。
手术器械可以被构造为对应于手术操作分流视频数据。
手术器械和控制台可以被构造为如同在工业、科学以及医疗(ISM)无线电频带中的一个或多个中的FCC注册装置一样运行。
工业、科学以及医疗无线电频带可以包括2.400GHz至2.500GHz的ISM频带。
根据本发明的示例实施例,手术器械包括具有壳体的手持式、电池供电的驱动单元和被构造为容纳手术附加装置的相应部分的安装部。驱动单元还包括被构造为致动至少一个连接部件的致动器,当附加装置被安装到安装部上时,连接部件与附加装置的相应部件紧密配合,以允许致动至少一个连接部件来驱动附加装置。驱动单元进一步包括被构造为注册用户指令的用户控制元件和被布置在壳体中并且被构造为对应于用户指令从用户控制元件接收用户输入信号的处理器,所述处理器被构造为根据作为用户输入信号的功能的操作程序控制连接部件的致动。驱动单元还包括收发器,所述收发器被构造为经由无线双路通信链路向远程控制台传达运行数据和指令中的至少一个并且从远程控制台接收运行数据和指令中的至少一个。
处理器可以被构造为通过调整驱动致动器的输出电压来控制至少一个连接部件的致动。
驱动单元可以被构造为确定对应于附加装置的序列号。
驱动单元可以被构造为确定对应于附加装置的附加装置类型。
处理器可以被构造为从包括对应于多种不同附加装置类型的软件的软件数据库中选择操作软件。
该器械可以包括存储器,软件数据库存储在存储器中。
该器械可以包括用于接收更新软件的接口。
驱动单元可以被构造为在至少一个连接部件的致动期间向远程控制台分流运行数据。
驱动单元可以被构造为从附加装置接收视频数据流并且向远程控制台发送视频数据流。
驱动单元可以被构造为如果没有建立双路通信链路则防止致动器的致动。
动力单元可以被构造为如同在工业、科学以及医疗(ISM)无线电频带中的一个或多个中的FCC注册装置一样运行。
工业、科学以及医疗无线电频带包括2.400GHz至2.500GHz的ISM频带。
该器械可以包括能够连结到驱动单元的多个手术附加装置。
根据本发明的示例实施例,控制台包括存储器、被构造为处理存储在存储器中的数据的处理器以及被构造为与远程手术器械通信的收发器。该控制台被构造为,从手术器械接收识别数据,基于识别数据注册手术器械,以及在手术器械和控制台之间建立无线双路通信链路。控制台还被构造为从手术器械接收运行数据和指令中的至少一个,以及基于运行数据和指令中的至少一个在手术器械运行期间向手术器械的用户提供运行反馈数据。
控制台可以包括被构造为显示经由双路通信链路从手术器械接收的运行数据的显示屏。
控制台可以具有被构造为实现a)传达运行数据以及b)接收用户指令中的至少一个的直观显示屏。
控制台可以被构造为从手术器械接收视频数据流。
控制台可以被构造为向外部显示器输出对应于视频数据的视频信号。
控制台可以被构造为向手术器械传递a)运行程序和b)固件中的至少一个。
控制台可以包括被构造为向手术器械输出a)运行程序和b)固件中的至少一个的编程端口。
控制台可以被构造为将从手术器械接收到的运行数据记录到存储器中。
控制台可以被构造为利用有线连接器向远程装置传达存储的数据。
控制台可以被构造为经由因特网传达存储的数据。
根据本发明的示例实施例,一种方法包括:以无线方式从手术器械向控制台发送识别数据,将手术器械注册到控制台上,并且在手术器械和控制台之间建立双路无线通信链路。所述方法还包括在手术器械和控制台之间传递运行数据和指令中的至少一个并且基于运行数据和指令中的至少一个在手术器械的运行期间从控制台向手术器械的用户提供运行反馈数据。
所述方法可以包括,判定无线发送的识别数据的信号强度是否低于预定阈值,如果信号强度被判定为低于预定阈值,要求在注册之前进行用户确认。
所述方法可以包括在控制台上保持已由控制台注册的手术器械的列表。
下面,参考附图更加详细地说明本发明的示例实施例的进一步细节和方案。
附图说明
图1a至1c为根据本发明的示例实施例的控制台的前视图。
图2为控制台的底视图。
图3为控制台的后视图。
图4为根据本发明的示例实施例的系统的示意性图解。
图5a和5b示出了根据本发明的示例实施例的智能驱动单元和手术附加装置。
图6示出了当手术附加装置连接到智能驱动单元时的智能驱动单元和手术附加装置。
图7a和7b示出了智能驱动单元。
图8a至8c示出了驱动单元的内部构件。
图9示出了驱动单元的连接部。
图10示出了手术附加装置的连接部。
图11示出了根据本发明的示例实施例的手术附加装置和附加装置轴。
具体实施方式
参考图4,示意性地示出了根据本发明的示例实施例的系统10。系统10包括与布置在例如相同的医疗护理或手术室中的与控制台100相同的区域150中的医疗和/或手术器械200a、200b和200c通信的电子控制台100。应当理解为,控制台100可以与例如八个以上器械的多个器械、和/或例如单个器械的较少器械进行通信。然而,为了示例的目的示出了三个器械200a、200b和200c。这些器械可以为例如手持式手术器械(例如,具有能更换的手术附加装置的电池供电的手术智能驱动单元)或者在控制台100的通信范围内的任何其他医疗和/或手术器械。控制台100可以被构造为在给定时间与一个手术器械200a、200b或200c进行通信和/或同时与两个以上手术器械200a、200b和/或200c进行通信。
控制台100向可以是例如无线智能动力或驱动单元500的一个以上器械200a、200b和200c的操作员提供反馈,下面将进行更加详细的说明。控制台100还具有识别语音和向手术器械200a、200b和/或200c发送无线指令的能力。在从手术器械接收到无线指令时,可以以多种语言显示口头(verbal)和视觉提示。控制台100可以从手术器械接收分流视频并且向例如手术室监控器上用于显示的单独视频接口窗口(pod)输出视频,其中,手术器械具有摄像机。控制台100具有一个以上电路板,该电路板包括处理器104(例如,ARM9级微处理器)、微控制器、序号识别集成电路(IC)、声频IC和/或放大器、图形显示器110(例如,LCD显示器)、以太网接口140、USB接口145、手术器械编程接口(包括例如收发器102和/或USB接口145,在图3中示出的)。如下面所述,尽管应当理解为替代壁适配器或除了壁适配器之外可以设置其他的电源,控制台100从外部UL/CE认证的AC壁适配器接收供电。
此外,例如,当手术器械200a、200b、200c例如在显示器110上以无线方式指示时,控制台100可以以多种语言显示提示。例如,当手术器械200a、200b、200c以无线方式指示时,控制台100能够以多种语言讲出提示。控制台100包括利用例如适配器电缆或无线连接器或链路更新手术器械软件的电路。控制台可以在例如经过因特网和/或企业内部互联网的网络或者经由USB端口145或存储器卡的任何其他适当的机构来接收这些更新。控制台100能够发送器械信息,例如,与诸如下面详细说明的附加装置600的手术附加装置的使用相关的信息,在例如附加装置600为吻合器的情形下,可以通过控制台100经过因特网发送吻合钉再装载和附加装置使用数据。
在示例中,控制台包括能够接收例如400MHz频带的手术器械发送信号的射频(RF)接收器和能够在900MHz至5.8GHz的频带中双路通信和/或视频分流的RF收发器。控制台100能够处理接收到的分流视频、参数和/或提示信息,并且向例如手术室监控室的外部显示器上的用于显示(覆盖)的例如单独视频窗口输出分流视频、参数和/或提示信息。示例控制台100包含能够处理语音指令并且以无线方式发送指令以操作例如后面说明的智能动力或驱动单元400的手术器械的语音识别能力。
此外,如下面更加详细地阐述,无线通信可以利用一个以上工业、科学以及医疗(ISM)无线电频带,例如,2.400GHz至2.500GHz的ISM频带,并且控制台100和/或手术器械200a、200b和200c可以为FCC认证的以在该频带上工作。一种或多种ISM频带可以用于手术器械200a、200b、200c和控制台100之间的单向和/或双路或双向通信。然而,应当理解的是,控制台100和/或手术器械200a、200b、200c可以使用任何适合的频带。而且,尽管该示例使用了从手术器械200a、200b、200c到控制台100的单向频道和手术器械200a、200b、200c之间的双路频道二者,应当理解的是,可以省去单向频道,以使例如全部通信发生在一个以上双路通信频道或链路上。
如上所示,控制台100经由双路无线链路与器械200a、200b和200c中的每一个进行无线通信。在这点上,控制台100包括包含收发器102的无线通信设备或装置106,以容许通过在无线收发器102与分别对应于器械200a、200b和200c的各个无线通信设备或装置206a、206b和206c的各个无线收发器202a、202b和202c之间发送和接收通信数据而在控制台100与器械200a、200b和200c之间进行双路无线通信。除了收发器之外,该示例的无线通信装置106还可以包括接收器。接收器可以被构造为从可以被设置到器械200a、200b和200c上的无线发送器接收单向无线发送信号。单向链路可以使用与双向或双路通信链路的频率不同的例如400MHz频带的频率,其可以在讨论的一个以上ISM频带或者其他频带上工作。
可以以不同的方式使用这一单向链路。例如,器械200a、200b、200c可以在单向链路上向控制台100的接收器发送识别信息,并且,一旦在控制台100上进行电子注册,经过双路通信链路与控制台100进行通信。作为选择或者另外,单向通信链路可以被设置为容许用于在器械200a、200b、200c与控制台100之间通信的更大带宽。
为了便于实现各种功能,例如数据的存储、处理和/或发送/接收,控制台100和各个器械200a、200b和200c包括用于存储数据的例如固态和/或磁盘内存储器的存储器103、203a、203b和203c,以及用于例如处理数据并且启动数据的发送/接收的处理器104、204a、204b和204c。
如上所示,无线链路可以使用一个以上工业、科学以及医疗(ISM)无线电频带,例如,2.400GHz至2.500GHz的ISM频带。控制台100和/或器械200a、200b和200c可以为FCC认证,以在这一或任何其他适合的ISM频带中工作。然而,应当理解的是,控制台100和/或器械200a、200b和/或200c可以如可以在任何适合的频带上运行的未许可设备一样工作。此外,无线协议可以遵守802.11b、802.11g和/或任何其他适合的协议、标准或修订。应注意的是,在例如2.400GHz至2.500GHz的ISM频带上的认证操作可以有利于限制例如小电子设备的其他设备的干扰。而且,对于注册的器械,与一些其他ISM频带相比,在2.400GHz至2.500GHz的ISM频带上可以较少地限制动力的级别和容许通信的数据的类型。
参考图1a至图1c,控制台100包括壳体105。本示例的壳体105由ABS塑料形成并且具有小于3.25英寸的高度、小于5.75英寸的宽度、小于1.75英寸的深度以及小于1.5磅的重量。然而,应当理解的是,壳体可以为任何适当的尺寸、大小以及重量。然而,壳体105的紧凑尺寸和重量可能是有利的,增强了控制台100的便携性和/或装载性、如何安装控制台100和将控制台100安装在哪的灵活性,和/或减小了例如在手术室中占用空间的量。
显示器110被布置在壳体的正面上,以便向手术器械的操作员(例如,外科医生)提供直观的指示。尽管显示器110为集成的触摸屏液晶显示器(LCD),应当理解为,可以设置其他的显示器,例如,有机发光二极管(OLED)显示器和/或非触摸屏显示器。显示器可以为例如彩色240乘320线分辨率的QVGA显示器或者任何其他适当的彩色或非彩色显示器。而且,应当理解的是,不是一定要设置集成的直观显示器。例如,控制台可以仅依靠与操作员的听觉通信(例如,经由连接到集成扬声器125的音频集成电路或者向外部扬声器的声音输出信号)和/或可以向例如手术室中的监控器的外部显示器输出直观图像和/或视频。
如下面所示,除了集成显示器之外,示例控制台100包括集成扬声器和视频输出连接器,从而为与操作员通信提供灵活性。如上所述,视频输出连接器可以用于连接到外部窗口和/或显示器,以显示例如由控制台100从手术器械200a、200b、200c接收到的分流视频信号。
显示器的前部还包括备用开关112,可以按下备用开关112以将控制台100置于备用模式或者使控制台断电。例如,短时按压可以指示控制台100进入备用状态或者退出备用状态,而长时按压可以指示控制台100通电或断电。备用开关112由备用符号113指示。
为了调整例如来自例如扬声器125的发音或音调指示和/或到外部扬声器的声音引出线的听觉指示的音量,音量级显示和控制件114被显示在显示器110的下部。音量符号109向用户表明,随着显示和控制件114的条的填充部分向右移动,音量增加,反之亦然。用户可以通过例如轻敲音量控制件114的条上的特定位置以向该位置移动填充部分和/或通过触摸控制件114附近的屏幕并且在与期望音量变化对应的方向上进行滑动运动来调整音量级。例如,如果用户使用例如食指来触摸控制件114并且沿着屏幕向右滑动食指,则条的填充部分可以以与滑动的距离对应的量扩大。同样,向左滑动或点击可能引起填充部分缩减,导致较低的音量输出。根据示例,在点击的距离与填充部分或其他指示物的边缘移动的距离之间存在一对一或基本上一对一的对应关系。可以以例如使用虚拟数字垫或键盘输入数值的模拟的方式或以任何其他适当的方式来调整包括例如与手术器械200a、200b、200c的运行相关的设定和/或与控制台的运行相关的设定的其他设定。
参考图2,控制台100的底部包括用于快擦写或固态存储器卡(例如,SD卡或任何其他适当的存储器)的槽口115和两个安装支架连接器或孔120,所述两个安装支架连接器或孔120用于容纳一个以上安装支架的相应连接器以将控制台100牢固地保持在例如在手术室中操作员能够看到显示器的位置处。
参考图3,控制台的后部包括用于向操作员输出听觉信息的封闭扬声器125。控制台的后部还包括用于向例如外部显示器和/或记录设备输出视频信号的组合视频连接器130和例如4引脚微型DIN的S视频连接器(S-videoconnector)135。控制台100的后部还具有网络连接器140。尽管网络连接器140为以太网插口(在这一示例中为,RJ-45,IEEE 802.3),但应当理解为,可以使用例如同轴电缆连接器的任何适合的网络连接器。尽管可以使用无线网络连接器,但有线连接经由网络连接器可以容许更安全的通信。
控制台100还具有编程端口145。在这一示例中,编程端口被设置为通用串行总线(USB)连接器145。更具体地,示例端口145为USB微型AB端口。然而,应当理解为,编程端口可以为被构造为发送和/或接收数据的任何类型的端口,例如,同轴电缆、专用连接器、和/或例如红外接收器和/或例如蓝牙接收器的其他无线协议接收器的接收器。编程端口145被构造为经由手术器械上的数据电缆和相应的连接端口向一个以上手术器械上载软件或其他数据。应当理解的是,USB端口可以用作例如通用数据端口和/或被构造为接收包括用于控制手术器械200a、200b、200c的软件的手术器械数据。除了接收数据之外,编程端口145可以用于从控制台100向例如外部硬盘驱动器、计算机和/或固态存储器设备的外部设备传递数据。
软件和/或数据可以被上载到控制台100中,以便被安装在控制台100和/或手术器械200a、200b、200c上。接收到的数据和软件可以经由网络280、例如USB端口145的任何适合的端口和/或利用例如收发器102的无线通信系统传递到控制台100中。
接收到的数据和软件可以包括例如运行和控制算法、校准数据、显示信息和/或任何其他软件,以便于手术器械200a、200b、200c的运行。此外,编程端口145可以用于将控制台固件安装到控制台100上或者升级控制台固件和/或将手术器械固件传递到控制台100以被传递并且安装到手术器械200a、200b、200c上。
电力经由电连接器150提供到控制台100,电连接器150容纳插入壁插座中的AC适配器的相应连接器。然而,应当理解的是,控制台100可以设有内部AC/DC转换器和/或可以设有例如可再充电的内部或外部电池的电池以供电。此外,应当理解的是,可以通过诸如USB端口的端口来供电,例如编程端口145。
尽管特定特征表示为被布置在壳体105的特定面上或者在控制台100的特定位置处,应当理解为,任何特征或特征的组合可以被布置在壳体105的任何适合的位置或面上。
在通电时,控制台100进行自我测试和配置,然后等待从例如一个以上器械200a、200b和200c的一个以上器械接收通信信号。控制台100可以提示用户或操作员使手术器械通电以便开始通信。
各个器械200a、200b和200c具有可以存储在例如存储器203a、204b、204c中的序列号。在器械通电时,例如,在插入电池组和/或启动电源开关或按钮时,器械开始对应于其各个序列号传送数据。器械利用例如如上所述的无线收发器202a、202b、202c或单向通信发送器来发送该信息。
在控制台100接收到对应于各个器械200a、200b或200c的序列号发送的识别数据时,控制台100经由显示器110和/或外部显示器来显示器械的类型和器械标识符,例如,序列号的最后三位数字或整个序列号。除了信息的直观显示之外或者作为信息直观显示的选择,例如数字化或从扬声器125预先记录的语音的听觉指示可以将信息传达给用户或操作员。控制台100经由例如无线收发器102或者单向接收器接收识别数据。然后,控制台可以提示用户是否注册识别的器械,或者控制台可以自动注册器械。如果控制台100提示用户,则用户可以通过例如触摸触摸屏显示器110(例如,触摸标签为“是”或“否”的框或图形)来回应提示。
应当理解的是,这里披露的从控制台100到用户或者操作员的任何通信可以经由视觉和/或听觉来发生,例如,口头表达,使用例如显示装置100、外部显示器、集成扬声器125、外部扬声器和/或任何其他适合的机构中的任一个、一些或全部的指示。
例如,在控制台100从器械接收到的信号为临界或者低于预定阈值的情况下,控制台可以提示用户,请求关于是否注册特定器械的指示或输入。用户可以通过例如触摸触摸屏显示器110(例如,触摸标签为“是”或者“否”的框或图形)来回应这一提示。如果没有接收到回应,控制台100可以缺省为“否”的回应,从而来自该特定器械的进一步通信不被识别和/或确认。
除了注册输入之外,触摸屏可以用于输入包括例如音量和语言的其他控制台参数。
应当理解的是,代替或除了触摸屏显示器110,可以利用适合的用户输入机构来执行这里披露的向控制台100的任何用户输入或指令,例如,按下单独的按钮和/或发声(例如,在控制台100具有麦克风和语音和/或话音识别软件的情况下)。
控制台100将哪个器械已经在控制台100上进行注册和哪个器械已经被拒绝在控制台100上进行注册的记录保持在例如存储器103中。该记录可以包括例如对应于注册器械的序列号的列表和对应于未注册器械的序列号的另一列列表。
当控制台100断电时,注册器械的列表和/或未注册器械的列表可以被清除,或者可以被保持直到例如输入了用户的删除指令、自从例如从特定器械接收到信号起已经过去一定量的时间、和/或占用了给定数量的槽口。例如,注册的器械的列表和/或未注册的器械的列表可以具有例如八个条目,随着后一个条目被记录,最早的条目被删除。保持未注册用户的列表可能是有利的,例如,至少当接收到的信号为临界时,避免对那些器械的进一步提示。例如,在使器械断电或者重启时,可以清除注册器械的列表,而未注册器械的列表被存储用于后来参考。
当例如器械200a、200b和200c中的一个的器械在控制台100上注册时,控制台100建立双路无线通信链路。控制台的通信范围可以为任何适当的范围,例如,十五英尺的半径或者更大。该双路通信链路允许控制台100从注册的手术器械200a、200b和/或200c接收包括例如指令的数据并且向注册的手术器械200a、200b和/或200c发送包括例如指令的数据。此外,该通信链路允许控制台100提供与例如外科医生的用户的界面,以便显示与器械的运行相关的信息,并且允许用户输入指令。
例如,器械的一个以上构件的参数和/或状态,例如,闭合比率(closingrate)和/或手术切割器和吻合器的夹紧钳夹所施加的夹紧力、从传感器和成像装置获得的数据,例如,从安装到内窥镜的一个以上摄像机获得的图像或者视频显示、和/或任何其他数据。
用户可以经由例如触摸屏显示器110的按压部分来输入指令。这些指令可以与例如手术器械200a、200b和/或200c的运行参数相关。例如,对于组织夹紧手术操作,用户可以输入要施加到组织上的最大力、功率和/或闭合比率。然后,控制台将根据指令与手术器械进行通信。例如,控制台100可以根据用户的输入设定和/或指示手术器械设定手术器械的运行参数来完成操作。可以通过添加、改变、和/或验证手术器械的运行中使用的一个以上值或者参数来设定这些参数,例如,存储在存储器203a、203b和/或203c中的软件或运行算法中使用的一个以上值或者参数,并且在各个手术器械200a、200b和/或200c的运行期间通过各个处理器204a、204b和/或204c来执行。
用户还可以请求与手术器械200a、200b、200c相关的特定数据。例如,用户可以在虚拟按钮和/或菜单位置处按压屏幕,以请求来自手术器械的摄像机的视频显示。在手术器械包括多个摄像机的情形下,或者在各自具有摄像机的多个手术器械被注册的情形下,用户可以例如选择在给定时间显示哪个或哪些视图。
此外,对应于正在执行的特定手术操作和/或手术操作的当前阶段或者其他状况,设置在存储器103、203a、203b和/或203c中并且由控制台100的处理器和/或手术器械200a、200b和/或200c执行的运行算法可以使显示器110和/或一个以上外部显示器显示数据(例如,图像、数值数据和/或表示手术器械或者患者的状态的数据等)、指令提示和/或菜单结构。此外,根据示例,屏幕具有虚拟按钮以产生菜单,其中,在菜单和/或子菜单下可选的选项根据特定手术操作、手术操作的阶段、手术操作的状况(例如,基于来自手术部位的传感器的数据)、手术器械的类型、和/或手术器械的一个以上构件的状态或位置而变化。
手术器械200a、200b和/或200c可以被构造为仅当手术器械在控制台100上被注册时能够进行手术上的操作。可以通过例如将软件或者固件安装到存储器203a、203b和/或203c中来实现这点,当由处理器203a、203b和/或203c执行时,禁止执行一个以上功能。例如,处理器204a、204b和/或204c可以被构造为仅当软件和/或固件判定器械已经被控制台100注册并且已经建立双路通信链路时向电动机和/或电动机控制器输出控制信号和/或电压。可以例如基于通过无线接收器202a、202b、202c接收到的通信信号来进行该判定。
手术器械200a、200b和/或200c可以周期性地或者连续地监控与控制台100的通信链路的状态,以便确保其仍旧在适当位置处。在这点上,手术器械可以例如向控制台100周期性地发送询问信号。如果询问信号被控制台100接收到,则控制台100发送回应信号以表示接收到了询问信号。在接收到回应信号时,手术器械将验证双路通信链路的存在。询问的频率可以变化,以使得在特定期间内询问较不频繁或者完全不发送询问,例如在如果手术器械由于例如休止期间进入备用状态的期间。此外,在手术器械与控制台之间的数据通信期间内可能不需要这种询问。而且,当例如运行数据、软件数据、图像数据、或者其他数据的数据被手术器械和控制台中的任一个接收到时,回应信号被发送以表示数据被接收到。这可以进一步确保通信链路被保持。回应信号可以包括例如标识符,从而特定通信信号(例如,特定询问信号或者数据传送)的接收可以被识别和确认。
如果手术器械200a、200b和/或200c判定通信链路已经断开(例如,由于在发送一个以上询问或者数据发送之后没有接收到回应信号),则手术器械可以禁止一些或全部功能,尤其是禁止一些或全部功能、和/或允许特定功能继续直到例如预定时间或者事件发生。在这点上,手术器械的软件或者固件可以被编程,以使得通信链路的丢失不防止例如外科医生的用户完成特定手术操作,例如,在中断该手术操作可能潜在地导致并发症的情形下。
在判定通信链路已经丢失时,手术器械200a、200b、200c可以发出信号,例如,通信链路已经丢失的听觉或者视觉信号。因而,用户将被警示并且可以试图重新建立通信链路。手术器械可以继续发送询问信号,例如对应于手术器械的序列号,直到接收到来自控制台的回应为止。
双路通信链路可以使用任何适当的安全或加密协议,例如,Wi-Fi保护访问(例如,WPA或者WPA2)或者无线等价保密(WEP)。
除了与手术器械200a、200b和/或200c的无线通信链路之外,控制台100可以被构造为在另一个网络280上发送和接收数据。控制台可以向作为服务器100的远程装置300发送信息并且从远程装置300接收信息,远程装置300例如为场外计算机或服务器、或者例如相同医院内的相同设施内的计算机或者服务器。远程装置300包括:存储器303,其被构造为存储从控制台100接收到的和/或发送到控制台100的数据;以及处理器304,其用于处理接收到的数据。远程装置可以包括任何其他适当的特征,例如,用于查看发送和/或接收的数据的显示装置,以及允许例如手动输入(例如,通过键盘)和电子数据输入的输入装置。网络280可以包括例如因特网和/或企业内部互联网。应当理解的是,控制台100可以通过例如计算机或者服务器(在传送数据之前其可以或者不可以处理数据)的中间装置在控制台100与远程装置300之间发送和接收数据。此外,应当理解的是,控制台100可以被构造为与设备300直接进行通信,而不是在因特网和/或企业内部互联网上传送数据。
尽管在图4中仅示出了一个远程装置,应当理解为,可以设置任何适当数量的远程装置。例如,一个以上装置300可以被设置在与控制台100相同的设施中,和/或一个以上设备可以被设置在场外,例如,在手术装备管理者的场地中。
在图4的图解示例中,控制台100通过安全的有线连接250连接到装置300。尽管有线连接250基于以太网,应当理解为,可以设置任何适当的有线连接。还应当理解的是,尽管图解示例仅使用有线连接,根据一些示例,可以使用至少一个无线连接。然而,由于可以建立更安全的连接以更加确保发送数据的保密性,仅使用有线连接可能是有利的。可以使用例如提供控制台100与远程装置300之间通信的充分安全线路的数据加密协议来发送数据。
控制台100可以向远程装置300发送与手术器械200a、200b和/或200c的运行和/或状态相关的数据。例如,控制台100可以将通过通信网络从手术器械接收到的数据记录到存储器103中并且将在例如处理或者不处理数据的情况下将数据发送到远程装置300。数据可以包括例如连结到手术器械的手术附加装置的类型、手术附加装置的序列号、手术附加装置的最后使用的日期和/或时间、什么时间运行特定功能、运行特定功能多长时间、什么时间启动例如触发器或按钮的用户输入和/或启动例如触发器或按钮的用户输入多长时间、异常操作的任何错误信号和/或指示、传感器数据(例如,图像传感器、温度传感器、压力传感器等)、特定插入件和/或钉仓(例如,手术吻合器的吻合钉钉仓)的标识符和/或序列号、特定插入件和/或钉仓最后使用的日期和/或时间、手术器械的电池水平和/或电池健康状况、和/或属于手术器械和/或手术操作的任何其他数据。
数据可以被发送到手术器械管理者的远程装置300,其可以位于例如手术场地之外的位置处。远程装置300可以通过以规则间隔的周期性发送和/或由例如在控制台100断电之前完成一个以上手术操作的具体事件触发的发送来获取数据,和/或在控制台100从远程装置300接收到请求或者询问信号时从控制台100获取数据。
控制台100、远程装置300和/或管理者可以将接收到的数据用于各种用途。根据示例,可以确定手术器械或者手术器械的构件(例如,手术附加装置)的清洁或消毒状况。在这点上,可以将一组手术器械和/或附加装置的清洁和/或消毒状况保持为记录或者数据库。
可以从远程装置300接收该数据,例如用于记录何时对特定手术器械进行清洁或消毒的、清洁站的计算机。在从手术器械200a、200b、200c接收到表示特定手术器械和/或附加装置的数据时,例如与手术器械的序列号和/或附加装置的序列号相对应的数据,控制台可以交叉引用具有清洁状况数据的该识别数据,以便判定自从上一次使用之后该特定手术器械和/或附加装置是否已被清洁和/或消毒。作为选择或者除此之外,控制台可以向例如服务器的远程装置300发送数据,然后远程装置300将处理数据以对特定器械或构件自从前次使用之后是否已被消毒进行判定,并且然后将结果发回控制台100,然后控制台可以继续允许手术器械200a、200b、200c运行或者不允许运行。
如果不允许运行,则控制台100和/或手术器械可以发出听觉、视觉和/或其他警示或通知,以表示在当前状态下不能够运行手术器械。以此方式,控制台100可以防止手术器械运行,直到清洁和/或消毒信息被更新表示手术器械的所有适当部分已被清洁和/或消毒为止。
此外,通过跟踪手术器械或者手术器械的例如附加装置的构件的使用和/或故障历史,可以便于器械的维护和维修。例如,在使用一定次数和/或一定量的时间消逝之后,可以判定手术器械200a、200b、200c或者手术器械的附加装置或构件需要维修或更换。如果记录了特定错误或者故障,或者在使用器械或者构件的期间记录了一定数量和/或频率的错误或故障之后,则可以通过例如软件程序确定需要修理。如果手术器械或者手术器械的构件到了维修期或者过了维修期或者需要修理,则控制台100可以防止手术器械运行和/或用户可以被控制台或者手术器械警示。
控制台100还可以通过例如记录手术器械200a、200b、200c使用的吻合钉、钉仓或者其他装置的数量来跟踪库存。在一个示例中,控制台可以将吻合钉钉仓的序列号与特定患者相关联。这使得可以跟踪吻合钉,并且可以识别具有特定吻合钉批号或类型的趋势或问题,例如,在与吻合钉的其他批号和/或类型相比大致高数量的患者具有来自于使用特定批号和/或类型的吻合钉的吻合钉的手术操作的并发症。尽管在本示例中提到了吻合钉,该跟踪程序可以用于识别使用其他装置的趋势。
通过根据一些示例跟踪指令和/或其他数据信号(例如,图像、传感器信号等)的顺序、时间以及持续期间,控制台100记录下给定手术操作的精确记录。该记录可以用于例如训练目的和/或例如在记录链接到特定患者的情况下反驳医疗失当的主张。
应当理解的是,可以在例如既定医院的既定设施中使用多个控制台。在此情形下,由各个控制台100记录的数据可以为与其他各个控制台100记录的数据整合或者组合,以使尽管在不同控制台上被注册,手术器械200a、200b和/或200c还是可以在给定次数被精确地跟踪。例如,如果手术器械为手持式手术切割器/吻合器,则可以在各自具有自己的控制台100的两个手术室中任一个中使用器械。数据的这种整合或组合还可以便于其他跟踪,例如,手术器械的位置的跟踪、用于例如自动再定购等的存货(例如,吻合钉)的库存跟踪等。
可以通过例如手术器械管理者或者医院的计算机或者服务器的远程装置300和/或通过一个以上控制台100(例如,控制台100在网络280上进行通信的情形)来执行来自不同控制台100的数据的整合。
除了经由连接250取回记录数据之外,可以通过访问能够从槽口115拆除的例如快擦写或者固态存储器卡的存储器来取回数据,控制台100被构造为或者自动地或者在收到例如用户指令时将数据写到存储器中。然后,通过将存储器插入存储器卡读取器中,可以由例如远程装置300和/或便携式计算机来读取可拆除存储器。应当进一步理解的是,可以经由USB或者例如编程端口145的其他数据端口来取回信息。
图5a、图5b和图6示出了包括上述手术器械200a、200b和200c的全部特征的手术器械400。手术器械400由智能动力或驱动单元500和可拆除附加装置600构成。在该示例中,可拆除附加装置600为用于夹紧、切割以及吻合组织的手术附加装置。因而,如图6所示,附加装置600安装到驱动单元500上,以使手术器械400被构造为用于夹紧、切割以及吻合组织的手持式、电池供电、转动和/或关节式运动器械。
尽管能够从智能驱动单元500拆除附加装置600,应当理解为,附加装置600可以被形成为不能够从智能驱动单元500拆除。
手术器械400被构造为特别适合于经由插管插入患者的身体中。如上所示,在所示的实施例中,手术器械400为夹紧、切割以及吻合的器械。手术器械400的可拆除附加装置600包括通过铰链部611c枢接到轴部611b的钳夹部611a。钳夹部611a包括具有远端和近端的第一钳夹650,以及具有远端和近端的第二钳夹680。第一钳夹650和第二钳夹680相对于彼此枢接到其各自的近端或者各自近端的附近。如图所示,第一钳夹650和第二钳夹680能够绕枢轴A相对于彼此枢转。在这一设置中,钳夹被构造为使得,在第一钳夹650相对于第二钳夹680打开和闭合时以及在第一钳夹650相对于第二钳夹680移动中的点处,第一钳夹650和第二钳夹680二者,例如二者的纵轴,保持在一个平面内。然而,应当理解为,附加装置600可以被构造为,使得第一钳夹650和第二钳夹680绕定向不同于所示的枢轴相对于彼此枢转。
如上所述,钳夹部611a能够通过铰链部611c枢接到轴部611b。具体地,钳夹部611a能够绕枢轴B相对于轴部611b枢转,枢轴B可以位于钳夹部611a和轴部611b上或二者之间的任意位置处,以及在相对于钳夹部611a和轴部611b的任意圆周位置处。如图5b所示,枢轴B垂直地定向,并且在与图5所示的侧视图的视角垂直的平面内。在这一设置中,钳夹部611a和轴部611b被构造为使得,在钳夹部611a相对于轴部611b关节式运动时以及在钳夹部611a相对于轴部611b移动中的任意点处,钳夹部611a和轴部611b保持在与枢轴B垂直的平面内。应当理解的是,在其他示例实施例中,枢轴B可以具有不同的定向,从而使得钳夹部611a能够在不同平面内枢转。钳夹部611a可以相对于轴部611b枢转到任何角度并且在任何角度之间枢转,以使得在使用中能够如期望地选择性地定位钳夹部611a。
此外,手术器械400可以提供各种构件绕附加装置600的纵轴的转动。例如,在各个实施例中,钳夹部611a和/或轴部611b可以相对于智能驱动单元500转动,如图6所示,智能驱动单元500绕着智能驱动单元500的纵轴D(例如,在智能驱动单元连结到附加装置600的点处的智能驱动单元500的纵轴D)连结到附加装置600的轴部611b的近端或者近端的附近。轴部611b可以包括钳夹部611a连接的远侧部,以及当附加装置600安装到智能驱动单元500时朝向智能驱动单元500的近侧部。
通常,例如如图7a和图7b中所示,智能驱动单元500的手柄状轮廓可以由操作员抓握以操作手术器械400。智能驱动单元500具有下部502,在所示的实施例中形成基部。另外,智能驱动单元500具有包括几个手指开动控制按钮507和508以及摇杆装置517的中间部504。
图8a至图8c示出了驱动单元500的内部构件,示出了智能驱动单元500内部的构件的补充细节。诸如电池506的电源可以位于由智能驱动单元500的近侧部502提供的壳体中。电池506可以被构造为向手术器械400的任一构件供电。该设置可以提供的优于其他手术器械的优点在于:可以免除手术器械400到单独的机电手术系统的电源的连接件。然而,应当理解的是,其他示例的手术器械可以连接到单独的机电手术器械以接收机械功率和/或电功率。
同样,智能驱动单元500的中间部504提供了定位电路板509的壳体。电路板509可以被构造为控制手术器械400的各种操作。
位于智能驱动单元500的中间部504的前面位置处的为控制按钮507、508以及摇杆装置517。控制按钮507、508以及摇杆装置517中的每一个包括各自的磁铁,通过用户或操作员的致动来移动磁铁。另外,对于控制按钮507、508以及摇杆装置517中的每一个,电路板509包括由控制按钮507、508以及摇杆装置517中的磁铁的移动致动的各自的霍尔效应开关。例如,紧靠近控制按钮507定位的为在操作员致动控制按钮507时控制按钮507内的磁铁移动时致动的霍尔效应开关。霍尔效应开关的致动使得电路板509向功能选择模块5210和致动器或者输入驱动构件5310提供合适的信号,以相对于第二钳夹680闭合第一钳夹650和/或启动第二钳夹680内的吻合/切割钉仓。例如,下压按钮507可以启动第一钳夹650相对于第二钳夹680的闭合或者夹紧,而下压按钮508可以启动吻合/切割钉仓,或者反之亦然。
而且,紧靠近摇杆装置517定位的为在操作员致动摇杆装置517时摇杆装置517内的磁铁移动时致动的霍尔效应开关。霍尔效应开关的致动使得电路板509向功能选择模块5210和输入驱动构件5310提供合适的信号,以使得钳夹部611a相对于附加装置600的轴部611b进行关节式运动。有利的是,摇杆装置517在第一方向上的移动可以使得钳夹部611a在第一方向上相对于轴部611b绕轴B进行关节式运动,而摇杆装置517在第二方向、例如相反方向上的移动可以使得钳夹部611a在第二方向、例如相反方向上相对于轴部611b进行关节式运动。
应当理解的是,可以根据例如能够连接到智能驱动单元500的各种附加装置要执行的功能的数量和/或类型来设置适当数量的按钮和/或摇杆。
此外,智能驱动单元500的上部提供了可以定位驱动机构5110(包括例如功能选择模块5210和输入驱动构件5310)的壳体。驱动机构5110可以被构造为驱动轴和/或齿轮构件,从而执行如上面阐明的手术器械400的各种操作。例如,驱动机构5110可以被构造为驱动轴和/或齿轮构件,从而相对于轴部611b选择性地移动钳夹部611a,相对于智能驱动单元500绕纵轴D转动轴部611b(或者手术附加装置600的远侧部),相对于第二钳夹680移动第一钳夹650,和/或在第二钳夹680内启动吻合和切割钉仓。
参考图9和图10,智能驱动单元500的远侧部包括被构造为容纳可拆除附加装置600的相应接口或连接部690的附加装置接口或者连接部590。智能驱动单元500的连接部590具有圆筒形凹部591,当附加装置与智能驱动单元500紧密配合时,圆筒形凹部591容纳附加装置600的圆筒形突出部691。然而,应当理解的是,附加装置的连接部690可以设有用于容纳智能驱动单元500的连接部590的突出部的凹部。而且,应当理解的是,接口不需要为圆筒形,并且可以为任何适当的形状或者几何结构。
当附加装置600与智能驱动单元500紧密配合时,多个可转动连接器592a、592b和592c中的每个与相应的可转动连接器692a、692b、692c连结。在这点上,相应连接器592a和692a之间的接口、相应连接器592b和692b之间的接口以及592c和692c之间的接口被锁定,以使得各个连接器592a、592b和592c的转动引起相应连接器692a、692b、692c的相应转动。尽管所示的接口轮廓为近似三角形,应当理解为,可以设置任何适当的几何结构以允许传输从第一连接器592a、592b和592c到各个连接器692a、692b和692c的转动。应当进一步理解的是,尽管连接器592a、592b和592c被设置为插入内孔连接器692a、692b和692c中的外孔连接器(male connector),但连接器692a、692b和/或692c可以被构造为构造为容纳在各个内孔连接器592a、592b和/或592c中的外孔连接器。
连接器592a、592b和592c与连接器692a、692b和692c的紧密配合允许经由三个相应的连接器接口的每一个单独传输转动力。连接器592a、592b、和592c被构造为由驱动机构5110单独转动。在这点上,功能选择模块5210选择由输入驱动构件5310(例如,电动机)驱动哪个连接器592a、592b和/或592c。然而,应当理解的是,连接器592a、592b和/或592c中的一个或多个可以设有专用驱动构件或者电动机。
由于当附加装置600连结到智能驱动单元500时各个连接器592a、592b和592c具有与各个连接器692a、692b和692c锁定和/或基本不能转动的接口,转动力可以从智能驱动单元500的驱动机构5110选择性地传递到附加装置600。
转动力可以经由沿着轴部611b设置的多个可转动驱动轴从附加装置600的近端部处的连接器692a、692b、692c传递到钳夹部611a。可转动驱动轴可以在近端非可转动地连结或者基本非可转动地连结到各个连接器692a、692b或692c,并且在远端非可转动地连结或者基本非可转动地连结到被构造为致动钳夹部611a或者其部分或构件的钳夹构件或者驱动器的输入端。以此方式,可转动驱动轴可以允许连接器692a、692b和/或692c与钳夹部611a之间一对一或者基本上一对一的转动传输。
连接器592a、592b和/或592c的选择性转动允许智能驱动单元500选择性地致动附加装置的不同功能。在该示例中,三个连接器的选择性且独立的转动对应于钳夹部611a绕轴B选择性且独立的关节式运动、由于上钳夹650绕轴A的转动引起的钳夹650和钳夹680的打开和闭合,以及钳夹部611a的吻合/切割构件的驱动。
附加装置600可以通过任何适当的机构连结到智能动力单元500。例如,附加装置可以利用可滑动闭锁机构(latch mechanism)(例如,动力单元500的径向向外部分被向后或向前径向拉动以脱离闭锁)或者卡盘闭锁到适当位置处。尽管可以设置需要单独工具的附加装置,但设置例如上述滑动闭锁、无键卡盘等需要较少工具或者手操作的连接机构可能是有利的。
驱动机构5110可以包括选择器(selector)齿轮箱组件550。接近选择器齿轮箱组件550的为起到将选择器齿轮箱组件550内的齿轮元件选择性地移动到与输入驱动构件5310啮合的作用的功能选择模块5210。因而,驱动机构可以在给定时间选择性地驱动连接器592a、592b和/或592c中的一个或多个。尽管基于选择器齿轮箱组件550的啮合状态选择性地驱动各个连接器592a、592b、和592c,但应当理解为,连接器592a、592b和/或592c中的一个或多个可以设有专用驱动构件或者电动机。
关于选择器齿轮箱组件550或者手术器械400的总体上的进一步细节,手术器械400包括与以引用的方式全部专门地合并于此的美国公布的申请号为2009/0101692的专利申请中披露的基本相同或者类似的许多特征。
智能驱动单元500还包括收发器,该收发器连结到电路板509并且被构造为如上所述相对于手术器械200a、200b和200c向控制台100发送数据传输和从控制台100接收数据传输。电路板509被构造为不允许例如钳夹部611b的各种功能的运行,除非确定与控制台100已经建立了双路通信链路。
智能驱动单元500的连接部590还包括与相应的电连接器693a和693b紧密配合的电连接器593a和593b,以允许智能驱动单元500与附加装置600之间的电信号和/或动力的传输。电连接器593a和593b电连结到包括例如电路板509的电路,以允许电路经由电连接器593a和593b接收和/或发送信息和/或电力。电信号可以为例如与例如手术附加装置类型和/或序列号、钉仓或插入件的标识符、传感器数据和/或任何其他适合的通信相对应的手术附加装置数据。该数据可以存储在手术附加装置和/或钉仓(例如,吻合钉钉仓)的电子芯片上。例如,吻合钉钉仓可以包括包含有序列号和/或批号的电子芯片。该信息可以经由连接器593a、693a、593b、693b的接口从芯片上读取并且转送到智能驱动单元500的电路。然后,电路板509可以经由收发器在双路通信链路上将数据发送到控制台100,其中,控制台100可以存储并且跟踪数据。
此外,附加装置类型和序列号可以被转送到智能驱动单元500。该信息可以被存储到例如附加装置600的电子芯片上。然后,包括例如电路板509的智能驱动单元500的电路可以将该数据传达到控制台100,控制台100可以选择包括例如操作程序、算法或参数的数据,并且经由双路通信链路将该数据发送到智能驱动单元500的电路。然而,应当理解的是,包括例如存储器的驱动单元的电路可以包括处理器509可以从中选择以运行附加装置600的多个预先安装的程序、算法和/或其他参数。
如上面关于手术器械200a、200b和200c所述,智能驱动单元500可以将由操作手术器械400的例如外科医生的用户输入的指令的记录发送到控制台100。例如,智能驱动单元500可以将与在手术操作中各个控制按钮507和508以及摇杆装置517什么时间运行、如何运行和/或运行多长时间相对应的信号发送到控制台100。然后,控制台100可以将该信息存储到例如存储器103上。如上所述,该信息可以与特定患者和/或手术操作链接并且可以由例如管理者收集。智能驱动单元500可以以预定间隔和/或在例如手术操作结束或者手术操作的部分结束的特定事件或者状况发生时在手术操作期间连续地发送该数据。
智能驱动单元500还可以被构造为监控输入驱动构件5310的参数。例如,可以测量驱动输入驱动构件5310的一个以上电动机的电流,以便确定由手术器械400施加的例如夹紧力的力。在这点上,智能驱动单元500和/或控制台100可以包括例如以引用的方式全部专门地合并于此的序列号为12/430,780的美国专利申请中披露的控制单元或者系统。在这点上,智能驱动单元500可以包括用于测量驱动输入驱动构件5310的电流的电流传感器、用于确定输入驱动构件5310的转动速度的速度传感器以及用于确定输入驱动构件5310的输出(例如,电动机的输出轴)的位置、和/或构件(例如,附加装置600的上钳夹650)的位置中的至少一个的位置传感器。然后,例如通过调整施加到输入驱动构件5310的电压来调整输入驱动构件5310的驱动速度,控制单元可以基于来自这些传感器的输入来控制输入驱动构件5310。在如图所示手术器械包括切割器/吻合器附加装置600的情形下,控制系统可以被构造为在例如用户压下按钮507的同时将钳夹650和钳夹680施加到被夹紧组织的夹紧力限制到预定的最大限值。
基于在例如手术操作中获得的感应的和/或确定的数据和参数,手术器械400可以在双路无线链路上将数据发送到控制台100,例如以便存储、处理、和/或用于向器械400的用户提供信息。例如,如图1b所示,钳夹650和钳夹680的闭合比率可以被发送到控制台100并且在显示器110上显示给用户。控制台100还可以基于例如在双路无线通信链路上从手术器械400发送到控制台100的信息在手术操作期间向用户传达警告和/或错误信号。
手术器械400(更具体地,智能驱动单元500)将运行数据和/或指令数据传达到控制台100,以允许控制台提供包括例如指示、询问和/或警示的反馈。运行数据可以包括例如测量的或确定的值、参数、状况等,而指令数据可以为送到控制台100的任何适当的指示,例如,询问用户的指示、显示状况或参数和/或发布警示。
而且,用户可以通过将指令输入到控制台100中来设定手术器械400的参数,然后,控制台100基于用户的指令在双路无线通信链路上与手术器械400通信。例如,基于来自用户的输入,控制台可以发送数据以警示运行算法要使用特定参数。例如,用户可以向控制台100中输入用于夹紧手术操作的力的限值。然后,控制台100可以设定例如上述控制系统的运行参数,以使手术器械400限制在夹紧手术操作中施加到被夹紧组织的力。
控制台100可以被构造为为了任何适当的目的接收用户的指令和/或提示用户发出指令。例如,用户可以从一组操作程序、模式和/或算法中选择。基于这些指令或输入,控制台100在无线通信链路上与手术器械400通信,以便例如安装操作软件和/或设定运行参数。根据示例,对于所选择的手术操作,程序可以从控制台100上被传达到并且安装到手术器械400上,其中,程序需要在特定顺序中和/或在特定条件下执行特定的功能。例如,手术器械400的电路可以忽略当确定例如钳夹之间的组织间隙不在可接受预定范围内时来自用于致动吻合钉驱动器的按钮或者其他输入端的输入信号(有效地禁止按钮的功能)。
当电池水平和/或健康状况低于特定阈值时,控制台100还可以警示用户。此外,控制台100和/或手术器械400可以被构造为当控制台100和/或手术器械400判定电池的电力可能不足以完成该手术操作时防止特定手术操作开始。例如,当用户经由例如触摸屏显示器110选择操作程序或者模式并且判定(例如,由控制台100)电池水平和/或健康状况不足(例如,基于在无线通信链路上从手术器械400发送到控制台100的电池和/或健康状况信息)时,控制台可以基于电池的当前状态来指示用户不允许操作,和/或可以在手术操作可以继续进行之前指示用户更换电池。
此外,如图7a所示,智能驱动单元500的中间部504由手柄部504a和触发器部504b构成。手柄部504a整体形成(例如,通过注塑成型)为一整件,包括容纳用户的较靠下的手指的管状部分。然后,触发器部504b以任何适当的方式(例如,使用粘结剂、焊接和/或紧固件)被接合到手柄部504a。类似地,上壳体510和电池壳体515各自整体形成为一整件并且接合到手柄部504a。电池506被电池门520限制在电池壳体515中,电池门520闭锁到闭合位置并且通过按下释放按钮525使电池门520解除闭锁。与沿着接缝(例如,在图7b的视图中近似平行于纸张的平面的接缝)接合两个近似对称的半部的构造相对照,这一构造可以提供增强的强度并且可以便于构件壳体部504a、504b、510、515和/或520的密封。
智能驱动单元500被构造为作为一个整体经受高压灭菌(autoclavable),无需拆开。在这点上,包括电池506的智能驱动单元500可以被高压灭菌,不会损坏智能驱动单元500的任何部分。为了便于这一高压灭菌,智能驱动单元500可以包括密封件或者例如衬垫570的衬垫(例如,在图8c中示出,被构造为在电池门520与电池壳体515之间形成足以防止湿气在高压灭菌的压力和温度下进入智能驱动单元壳体中的气密密封)。此外,当附加装置600连结到驱动单元500上时,如果期望,智能驱动单元500和附加装置600可以一起高压灭菌。
图11示出了根据本发明的示例实施例的手术附加装置600和手术附加装置轴800。示出的附加装置800不具有可以连结到其远端810的钳夹或者其他器械部分。附加装置轴800与附加装置600的轴的不同之处在于,细长的轴部811弯曲成一个角度。这可以允许例如在一些内窥镜手术操作中轴的远端810(以及连接到其的器械)更易于进入患者身体的部分中。尽管附加装置600和800包括刚性轴,应当理解为,可以设置柔性轴。
提供具有各种附加装置可以可拆除地连结到其上以被驱动的动力单元500的手术器械提供了不同的附加装置和/或附加装置类型可以使用相同驱动单元的灵活性。在这点上,可以预想,例如外科医生的操作员在单次操作期间可以使用多个附加装置。例如,对于肠切除、割除以及吻合操作,外科医生可以首先连接作为附加装置600的线切割器/吻合器,以便在要去除的组织的癌变部分的相对端切除和吻合。为了重新接合肠的剩余部分的两个密封端,外科医生可以通过从动力单元500拆开并且除去线切割器吻合器附加装置(例如,通过拉伸、推动、和/或转动闭锁机构或卡盘)而用圆形切割器/吻合器附加装置更换线吻合器/切割器附加装置,并且然后连接圆形吻合器/切割器附加装置。
在插入附加装置时,动力单元500可以通过例如从设置在附加装置中的电子芯片经由电连接器693a和693b读取数据来确定手术附加装置的类型和/或具体的手术附加装置。基于该信息,智能动力单元500和/或控制台100可以选择适当的操作程序和/或设定一个以上运行参数。
动力单元500和/或控制台100可以交叉引用与特定附加装置相关的校准数据。例如,如果已经预先确定具有特定序列号的特定附加装置需要校正因数来调整该附加装置的特性(idiosyncrasy),则该校正因数可以被组合到用于该附加装置的运行算法或者程序中。例如,对于特定附加装置类型,可以期望连接器692a、692b、692c中的一个的完全360度转动与在附加装置的远端的例如钳夹650的元件的期望位移或者转动(或者其他可计量的状态变化)相关联。这一期望关联可以构建到用于该特定类型的每个附加装置的操作程序中。然而(例如,在测试期间),如果确定特定单元需要比360度转动稍多或者稍少的转动以达到期望效果,当附加装置运行时,可以提供校正因数来导致(account for)各个附加装置的该特性。
尽管这里作为示例性手术附加装置说明了手术吻合器/切割器,应当理解为,可以提供多种类型的手术附加装置中的任一种并且由驱动单元500供给动力。
为了连接附加装置,通过将附加装置轴向地压入到驱动单元中使附加装置牢固地闭锁到驱动单元500中可能是有利的。此外,如上所述,没有工具的附加装置和拆除机构对于简化连接、拆除以及从驱动单元500更换手术附加装置可能尤其有利。
尽管已经参考特定示例和示例性实施例说明了本发明,应当理解为,前面的说明并不是限制。而且,这里说明的特征可以用于任何组合中。

Claims (28)

1.一种手术系统,包括:
手术器械,其被构造为无线发送专用于所述手术器械的识别数据;以及
控制台,其被构造为接收所述识别数据,基于所述识别数据注册所述手术器械,在所述手术器械与所述控制台之间建立无线双路通信链路,从所述手术器械接收运行数据和指令中的至少一个,并且基于运行数据和指令中的所述至少一个在所述手术器械的运行期间向所述手术器械的用户提供运行反馈数据。
2.根据权利要求1所述的手术系统,其中,所述反馈数据包括所述手术器械的运行参数。
3.根据权利要求1或2所述的手术系统,其中,所述手术器械被构造为当所述手术器械没有在控制台上进行注册时至少部分不能运行。
4.根据前述权利要求中任一项所述的手术系统,其中,所述手术器械为手持式、电池供电的手术器械。
5.根据权利要求4所述的手术系统,其中,所述手持式、电池供电的手术器械包括被构造为容纳不同类型的手术附加装置的智能驱动单元。
6.根据前述权利要求中任一项所述的手术系统,其中,所述控制台具有被构造为完成a)传达运行数据以及b)接收用户指令中至少一项的直观显示屏。
7.根据前述权利要求中任一项所述的手术系统,其中,所述手术器械和所述控制台被构造为如同在工业、科学和医疗(ISM)无线电频带中的至少一个,以及2.400GHz至2.500GHz的ISM无线电频带中的FCC注册装置一样工作。
8.根据前述权利要求中任一项所述的手术系统,其中,所述控制台被构造为向所述手术器械上载操作软件,所述手术器械被构造为执行操作软件。
9.一种手术器械,包括:
手持式、电池供电的驱动单元,其包括:
壳体;
安装部,其被构造为容纳手术附加装置的相应部分;
致动器,其被构造为致动至少一个连接部件,当所述附加装置安装到所述安装部上时,所述连接部件与所述附加装置的相应部件紧密配合,以允许致动所述至少一个连接部件,从而驱动附加装置。
用户控制元件,其被构造为记录用户指令;
处理器,其被设置在所述壳体中并且被构造为从所述用户控制元件接收与所述用户指令相对应的用户输入信号,所述处理器被构造为根据作为用户输入信号的函数的操作程序来控制连接部件的致动;以及
收发器,其被构造为经由无线双路通信链路对发向和来自远程控制台的运行数据和指令中的至少一个进行通信。
10.根据权利要求9所述的器械,其中,所述处理器被构造为通过调整驱动所述致动器的输出电压来控制所述至少一个连接部件的致动。
11.根据权利要求9至10中任一项所述的器械,其中,所述驱动单元被构造为确定与附加装置相对应的序列号和附加装置类型中的至少一个。
12.根据权利要求11所述的器械,其中,所述处理器被构造为从包括与多个不同附加装置类型相对应的软件的软件数据库中来选择操作软件。
13.根据权利要求9至12中任一项所述的器械,其中,所述驱动单元被构造为在至少一个连接部件的致动期间向所述远程控制台分流运行数据。
14.根据权利要求9至13中任一项所述的器械,其中,所述驱动单元被构造为从所述附加装置接收视频数据流并且将所述视频数据流发送到所述远程控制台。
15.根据权利要求9至14中任一项所述的器械,其中,所述驱动单元被构造为如果还没有建立所述双路通信链路防止所述致动器的致动。
16.根据权利要求9至15中任一项所述的器械,其中,所述驱动单元被构造为如同在工业、科学和医疗(ISM)无线电频带中的至少一个,以及2.400GHz至2.500GHz的ISM频带中的FCC注册装置一样工作。
17.一种控制台,包括:
存储器;
处理器,其被构造为处理存储到所述存储器上的数据;以及
收发器,其被构造为与远程手术器械通信,
其中,所述控制台被构造为:
从所述手术器械接收识别数据,
基于所述识别数据注册所述手术器械,
在所述手术器械与所述控制台之间建立无线双路通信链路;
从所述手术器械接收运行数据和指令中的至少一个,并且
基于运行数据和指令中的所述至少一个在所述手术器械的运行期间向所述手术器械的用户提供运行反馈数据。
18.根据权利要求17所述的控制台,其中,所述控制台包括显示屏,所述显示屏被构造为经由所述双路通信链路显示从所述手术器械接收到的运行数据。
19.根据权利要求17至18中任一项所述的控制台,其中,所述控制台具有被构造为完成a)传达运行数据以及b)接收用户指令中至少一项的直观显示屏。
20.根据权利要求17至19中任一项所述的控制台,其中,所述控制台被构造为从所述手术器械接收视频数据流。
21.根据权利要求20所述的控制台,其中,所述控制台被构造为向外部显示器输出与所述视频数据相对应的视频信号。
22.根据权利要求17至21中任一项所述的控制台,其中,所述控制台被构造为向所述手术器械传递a)操作程序以及b)固件中的至少一个。
23.根据权利要求22所述的控制台,进一步包括被构造为向所述手术器械输出a)操作程序以及b)固件中的至少一个的编程端口。
24.根据权利要求17至23中任一项所述的控制台,其中,所述控制台被构造为将从所述手术器械接收到的运行数据记录到所述存储器中。
25.根据权利要求24所述的控制台,其中,所述控制台被构造为经由有线连接和因特网连接中的至少一个向远程装置传送存储的数据。
26.一种方法,包括:
将识别数据从手术器械无线发送到控制台;
在所述控制台上注册所述手术器械;
在所述手术器械与所述控制台之间建立双路无线通信链路;
在所述手术器械与所述控制台之间传递运行数据和指令中的至少一个;以及
基于运行数据和指令中的所述至少一个在所述手术器械的运行期间向所述手术器械的用户提供来自所述控制台的运行反馈数据。
27.根据权利要求26所述的方法,进一步包括:
判定无线发送的识别数据的信号强度是否低于预定阈值;以及
如果所述信号强度被判定为低于所述预定阈值,则要求用户在注册之前确认。
28.根据权利要求26至27中任一项所述的方法,进一步包括在所述控制台上保持已由控制台注册的手术器械的列表。
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