CN101765414A - 独立外科手术中心 - Google Patents
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Abstract
一种生物组织切割和流体抽吸系统提供可独立于外部控制台操作的多个外科手术器械。在一些实施方案中,各个外科手术器械可以包括可直接用于所述外科手术器械的全部传感器和控制器,并且可以独立地使用。在一些实施方案中,器械彼此就状态信息进行通信,并且基于所述通信调节操作参数。
Description
发明领域
本发明总体涉及外科手术系统,并且更具体地,涉及包括可在没有外部控制台的条件下操作的仪器(instrumentation)的外科手术系统。
发明背景
医学外科手术的革新使得许多人从之前认为不可治疗或不可治愈的疾病中康复。例如,开发了修复包括眼的内部部件的人眼部分的各种眼外科手术程序以缓和不同的视觉疾病。随着医学外科手术发展和扩展到通常具有有限的可达性的人体的新区域,开发了更复杂的外科手术仪器。此外,外科手术仪器越复杂,则通常对外科手术仪器的精确度的要求越多。
为了提高外科手术程序中的精确度和准确度,通常将控制台集成到外科手术系统中。控制台可以用于例如调节使用的各种外科手术器械(instrument)的参数、监控外科手术器械的状态、和进行快速计算并且向医生和其它医学人员提供反馈以协助确定外科手术程序进行得如何。眼外科手术程序没有不同。例如,涉及眼内流体的外科手术移除的玻璃体切割术通常使用由容纳于大的控制台内的计算机系统驱动的仪器进行。控制台通常是固定的或容纳于无菌屏障(sterile barrier)外部的大的转动单元(rollingunit)中,并且包括直接与外科手术仪器连接的装置模块。使用位于无菌屏障外部的控制台,外科医生或其它有资格的医师在患者水平上操作仪器,同时至少一个其它医学人员在外科医生的指导下在控制台操作控制器。
发明概述
本发明的实施方案涉及可独立操作的用于进行外科手术和医学程序的外科手术系统,所述外科手术和医学程序例如为玻璃体切割术和其它眼外科手术程序。
根据本发明的一个实施方案,用于外科手术程序的独立系统由以下各项组成:包括处理单元的控制装置;和与外科手术程序相关且与控制装置可操作地连接的多个器械,其中所述控制装置和所述多个器械预先包装在一起,并且处理单元设置为控制预先包装的器械中的至少一个。器械可以是电器械(electrical instruments)。
根据本发明的另一个实施方案,外科手术系统由以下各项组成:包括处理单元的便携式外科手术盘(tray);与处理单元可操作地连接的多个器械;和用户输入装置,所述用户输入装置提供用于控制多个器械中的一个或多个的操作参数的用户输入,其中处理单元设置为接收用户输入并且将操作命令传输到多个器械中的一个或多个。
在本发明的另一个实施方案中,用于外科手术程序的自供能(self-powered)外科手术系统由以下各项组成:外科手术盘;多个手持器械;在外科手术盘和手持器械的至少一个中的功率源;和处理单元,其中处理单元设置为实施程序指令,所述程序指令包括用于以下各项的指令:检测来自至少一个功率源的功率;将功率从至少一个功率源引导至多个手持器械;和与多个手持器械中的每一个建立通信(communication)。
根据一个实施方案,便携式生物切割和抽吸装置包括:切割尖端;流体抽吸装置;和与切割尖端以及流体抽吸装置连接的集成的控制单元,其中所述控制单元设置为控制切割尖端和流体抽吸装置的切割和抽吸。
根据一个实施方案,便携式输注和抽吸装置包括:抽吸室;与生物组织切割和抽吸装置连接的抽吸线路,所述抽吸线路设置为将从外科手术部位移去的物质吸入抽吸室内;具有输注溶液的输注室;与输注室连接并且设置为将输注溶液注射到外科手术部位以维持外科手术部位中的压力的输注线路,其中所述抽吸室和输注室包括在一个单个的、一次性盒内。
附图简述
图1是在进行玻璃体切割术的过程中插入眼中的各种器械的框图;
图2a是包括根据本发明的一个实施方案的独立外科手术中心10的外科手术系统的框图;
图2b是以根据本发明的一个实施方案的外科手术盘的形式实现的独立外科手术中心的示意图;
图3是根据本发明的一个实施方案的独立外科手术中心的内部部件的框图;
图4是用于根据本发明的一个实施方案的独立外科手术中心的初始化和通信建立过程(process)的流程图;
图5是根据本发明的一个实施方案,以处于与手持件(handpiece)通信的外科手术盘的形式实现的独立外科手术中心的方框图;
图6是由根据本发明的一个实施方案的独立外科手术中心的处理单元实施的过程的流程图;
图7是根据本发明的各方面的独立外科手术中心的备选实施方案;
图8是根据本发明的一个实施方案,以输注/抽吸盒体(cartridge)的形式实现的独立外科手术中心的框图;和
图9是根据本发明的一个实施方案的独立外科手术中心的另一个备选实施方案的框图。
详细描述
图1是在进行玻璃体切割术的过程中插入眼中的各种器械的框图。玻璃体是填充眼例如眼101的中央的通常透明、凝胶状物质。在某些情况下,血液、碎屑或瘢痕组织可能在玻璃体中聚集,部分或完全阻碍视力。在这些情况下,可以进行玻璃体切割术,或眼的玻璃体的全部或一部分的外科手术移除。
为了进行玻璃体切割术,在巩膜103即眼的白色部分中制成许多切口。各种器械通过切口接近眼的中心。图1中的插入的器械包括手持生物组织切割器和流体抽吸工具(“手持件”)105、照明装置107,和输注装置109。手持件包括用于切割或移去眼的玻璃体的一部分的生物组织切割器,以及用于移除切割或移去的部分的抽吸器。输注装置用于替换流体和保持眼中的合适压力。照明装置用作用于在程序过程中检查眼的中心的光源。
本发明涉及一种可以在不使用外部外科手术操纵台的条件下操作的独立外科手术系统。在一些实施方案中,例如,模块的外科手术系统组成独立外科手术仪器。外科手术仪器可以包括,例如,一系列互连的手持器械,比如切割手持件和照明装置。在一些实施方案中,独立的器械具有自给的操作智能(self-sustaining operating intelligence),并且不依赖于来自控制源的命令,从而为外科医生或其它医师提供对在无菌场内的各个独立器械的充分且独立的控制。
尽管本文中描述的独立外科手术中心主要与玻璃体切割术程序有关,但是本领域技术人员应当认识到,所述中心还可以构造用于在包括眼或人体其它部分的所有组织上进行的其它医学程序。例如,晶状体乳化涉及使用类似的包括超声切割器和抽吸器的手持件移除眼的晶状体。对于各种其它应用,器械可以包括,例如,不同的切割器、抽真空装置、冲洗装置、观看装置、和/或照明装置等。根据本发明的一个实施方案,如果不是特定系统的器械的全部,则其大部分含有彼此独立地控制和操作它们自身的电路和电源。在一些实施方案中,器械可以经由无线连接彼此通信,并且一个器械可以起到主处理或控制单元的作用。因此,尽管所述描述可以通常涉及构造用于玻璃体切割术的本发明的实施方案的细节,但是所述描述并不意在表示其中可以利用本发明的唯一应用。尽管不同的程序可能涉及略微不同的实施方案,但是应当理解,可以通过也意在包括在本发明的精神和范围内的不同实施方案实现等同的功能和结构。
图2a是包括根据本发明的一个实施方案的独立外科手术中心10的外科手术系统的框图。独立外科手术中心10起到外科手术系统的控制装置的作用,并且经由有线或无线连接24f、24e、24d、24c、24b与一个或多个医学器械可操作地连接,所述医学器械例如,诸如一个或多个观看装置12、输注装置14、冲洗装置16、照明装置18,和切割装置20。独立外科手术中心10还与其它装置22经由有线或无线连接24a可操作地连接。这样的其它装置可以包括,但不限于,脚踏开关、第二显示屏幕、音频输出等。
根据本发明的一个实施方案,独立外科手术中心10还任选地经由连接24g与个人外科手术中心连接。优选地,连接24g是无线连接,尽管该连接可以备选地采取有线连接的形式。如在与本文同日提交的标题为个人外科手术中心(Personal Surgical Center)的美国申请中所详细描述的,个人外科手术中心26构造为监测各种医学器械的设置,而医学器械的实际控制经由独立外科手术中心10和/或经由包括在医学器械自身中的逻辑和电路。在这方面,独立外科手术中心10和医学器械12-20位于进行外科手术的无菌场内,而个人外科手术中心26位于无菌场外。以这样的方式,外科医生在外科手术过程中具有对独立外科手术中心10和器械的直接使用(access)和控制。
来自独立外科手术中心10的各种连接24a-24g可以是有线的或无线的。没有限制地,无线连接可以是无线局域连接,例如802.11连接,个人区域网络连接,例如蓝牙,或本领域中常规的任何其它无线电或蜂窝网(cellular)连接。有线连接可以为例如串行总线、并行总线、以太网(Ethernet)连接等。例如,切割装置20与独立外科手术中心10之间的连接24b可以是有线连接。此外,输注和抽吸线路可以将输注装置和冲洗装置与独立外科手术中心10和/或切割装置20连接。
独立外科手术中心10包括用于驱动和控制医学器械中的一个或多个的电路、电源和逻辑。根据本发明的一个实施方案,独立外科手术中心10以外科手术盘的形式实现。根据本发明的另一个实施方案,独立外科手术中心以具体的医学仪器,例如输注/抽吸盒的形式实现。根据后一实施方案,具体医学仪器不仅具有逻辑和电路以控制其自身,还起到控制其它器械的一些或全部功能的控制中心的作用。
图2b是根据本发明的一个实施方案以外科手术盘的形式实现的独立外科手术中心的示意图。在图2中所示的实施方案中,外科手术盘201容纳和控制可能与不同外科手术程序相关的各种医学器械。在一些实施方案中,图2的外科手术盘提供在程序进行之前,在某些情况下在程序进行之后,用于包装各个器械的无菌环境。在一些实施方案中,所述盘和容纳于盘中的器械设计为在一次使用后丢弃。
在图2b中所示的实施方案中,盘容纳各种可移出的手持器械和外科手术供给,包括手持件203、输注线路205、照明装置207、窥器209、注射器211、套管213,q-尖端215和人造眼泪的供给217。盘还容纳盒体,其包括抽吸室219、输注室221,和用于各个室的泵或类似装置。在图2b中示出的实施方案中,手持件经由抽吸线路210与抽吸室219连接,并且经由输注线路205与输注室221连接。
根据本发明的一个实施方案,盘与需要来自盘的功率或控制的容纳于盘中的外科手术仪器中的一件或多件有线或无线通信。盘还可以与不容纳于盘中的其它装置无线通信,例如,脚踏开关、和/或外部监控器。盘可以起到外科手术系统的各个器械之间的通信媒介的作用。在盘与外部监控器通信的实施方案中,整个系统总体上保持可独立地操作,并且监控器典型地仅起到数据收集、显示和储存容量的作用。
根据本发明的一个实施方案,各种医学器械,包括盘,设计为便携、重量轻且不昂贵的。在一些实施方案中,盘包括用于控制各种医学器械的内部电路和各种部件。内部部件可以包括,例如,处理单元、用户控制器、功率源和多个不同的界面装置。处理单元可以为,例如,微处理单元基单元,和ASIC等。界面装置可以包括,例如,与外科手术系统的其它器械通信的无线通信界面。功率源例如电池使得盘可以独立地供给功率,并且在一些实施方案中,向与盘连接的装置如手持件提供功率。在一些实施方案中,盘还可以包括显示器或扬声器,它们可以输出各种状态指示器或连接的器械的设置。
在一些实施方案中,盘设计用于一次性使用,并且盘的器械一起预先包装在无菌包装中。在这些实施方案中,可以正好在进行外科手术程序之前,在无菌操作区域内打开包装,并且启动盘和盘中的部件。这给予医师对无菌场中的所有可应用外科手术仪器,包括位于盘上的任何器械控制器和状态指示器的使用和控制。在一些实施方案中,通过启动,盘可以进行初始扫描或类似的信息获取处理,以确定在程序过程中可以与其通信的可用装置或器械。盘可以建立与盘的各种不同器械通常无线通信的线路。
根据本发明的一个实施方案,盘与手持件203和输注线路205连接。在生物组织切割应用中,手持件可以包括生物组织切割器,并且可以经由流体抽吸线路210与盘连接。在操作中,切割器切割或移去生物组织,而抽吸线路吸引移去的组织,在其中收集到隔离的抽吸室219中。输注线路205可以用于用流体或气态溶液或其它物质注射外科手术部位以代替抽吸的组织。例如,在玻璃体切割术中,通过输注平衡盐溶液代替抽吸的玻璃体来保持眼内的压力。输注流体可以容纳于盘的输注室中,或备选地容纳于位于输注室中的密封输注袋或囊中,并且通过输注线路以由位于盘上的控制器确定的速率输注到患者中。根据本发明的一个实施方案,抽吸室219和输注室221均位于单个的、一次性盒中。
在一些实施方案中,可以通过用于进行每一种各自的功能的单独的装置直接控制用于不同器械的操作参数,例如,切割速度、抽吸压力、输注速率和照明水平。例如,手持件可以包括用于控制切割速度和抽吸压力的控制器,从而在程序中为外科医生提供更直接的控制。备选地,与盘连接的输入装置用于控制医学器械中的一个或多个的参数。示例性输入装置是与盘无线连接的脚踏开关。外科医生可以使用脚踏开关控制例如切割速度和抽吸压力。盘接收对切割速度和/或抽吸压力的变化,并且进而基于接收的输入控制手持件。类似地,照明水平可以在照明装置上直接控制,输注速率可以通过位于输注线路上或盘上的控制器来控制。本领域技术人员应当认识到,除了脚踏开关以外,或代替脚踏开关,还可以将其它输入装置如旋钮、开关、和/或按钮用于控制输入。
盘还可以与各种器械通信以从各种器械获取状态信息,例如,器械设置、当前操作参数,和故障条件。例如,在照明装置可全部从盘分离,并且可以独立于盘起作用和被控制的条件下,盘仍然可以接收当前照明水平的信息和将该信息传递给外科医生或医师。根据本发明的一个实施方案,盘通过数据通信连接24g将监测到的信息发送至个人外科手术中心26。在一些实施方案中,信息可以显示在安装在盘上的内置显示器上。在其它实施方案中,可以结合其它输出或用户反馈方式,例如,一系列指示各种器械的当前参数或状态信息的LED。
图3是根据本发明的一个实施方案的独立外科手术中心10的内部部件的框图。根据示出的实施方案,独立外科手术中心10包括与无线通信界面303连接和通信的处理单元301、状态指示器如监控器或LED的集合305、抽吸装置307、输注装置309、多个用户控制器或其它输入装置311,和其它部件或电路313。功率源315也可以与各种部件连接,并且提供运行其它部件的功率。输注装置还可以与输注流体或气体的供给317例如平衡盐溶液的储存器连接。
处理单元301通过向一个或多个器械发送控制命令促进那些器械的运行,并且通过从外科手术系统的同一或其它器械收集当前参数设置和其它状态信息起到信息源的作用。在一些实施方案中,从所有连接的器械收集状态信息,并且通过盘与外科医生或外科手术系统的其它用户通信,并且任选地与个人外科手术中心26通信。
处理单元301可以基于用户要求控制医学器械。在某些情况下,所述要求可以来自位于独立外科手术中心自身上的例如按钮或可调节转盘形式的用户控制器。在其它情况下,用户控制可以从连接的装置例如图2b中所示的手持件或输注线路接收。在再另外的情况下,控制或调节要求可以从外科手术系统的远程器械例如照明装置18,或例如脚踏开关,经由无线通信界面303接收。
处理单元301处理用户要求并且产生命令信号,以发送到意欲调节的器械或装置。在某些情况下,独立外科手术中心10可以构造成指导或控制外科手术系统中特别装置的运行。例如,在盘作为独立外科手术中心的实施方案中,盘可以限于控制位于盘自身上或盘自身内的装置,例如,抽吸装置307和输注装置309。在某些其他实施方案中,处理单元301可以起到外科手术系统中的各种器械和装置的中央控制单元的作用,并且可以接收所有器械调节要求并且将相关控制命令发送至系统中的合适装置。
在操作时,用户要求可以从第一装置例如手持件接收,并且意欲调节第二装置例如抽吸装置。处理单元301可以直接调节抽吸装置的控制参数,其可以是例如离心泵、文丘里(venturi)泵、蠕动泵、或任何合适的真空基系统,或可以备选地为控制注射器或活塞以供给真空压力的电动机。可以对连接的输注装置进行类似的调节,其可以是例如通用一次性泵(disposable pump)、蠕动泵、哈佛装置注射器泵(Harvard apparatus syringepump)、弹簧负载注射器(spring loaded syringe)、或IV极(IV pole)。在某些情况下,输注溶液的供给与系统预先包装,所述溶液适合于系统意欲使用的具体应用。在玻璃体切割术程序中,预先包装的溶液可以是无菌平衡盐溶液。如果使用泵,则其可以向容纳平衡盐溶液的输注室加压,从而导致溶液进入眼中。备选地,独立密封的容纳平衡盐溶液的输注袋可以被输注室容纳并且与输注线路连接。输注室的压力水平可以升高,从而压缩输注袋,并且迫使平衡盐溶液流出输注袋进入眼中。
某些外科手术程序可以涉及气体交换,或液体和气体交换的组合。在本发明的一些实施方案中,输注装置309可以提供多个输注源,并且容纳各种类型的用于输注的液体和气体。在这些实施方案中,独立外科手术中心10还可以包括确定在外科手术程序中被应用的输注源的控制器。例如,对于包括含有液体溶液的输注源和含有空气流体或气态物质的输注源的外科手术系统,独立外科手术中心10可以提供在液体溶液交换或空气流体交换之间选择的控制器。
根据本发明的一个实施方案,独立外科手术中心还以设置监控器和状态指示器的形式向用户提供反馈。处理单元301接收来自多个连接的器械的状态信息,典型地通过用于连接的器械的数据通信线路进行,或通过用于远程器械的无线通信界面进行。处理单元汇编信息并且向外科医生或其它用户传达信息。根据本发明的一个实施方案,独立外科手术中心可以包括小的监控器或屏幕用于显示关于外科手术程序或仪器的信息。除了监控器以外,或代替监控器,还可以设置光学LED和/或音频扬声器以产生各种系统事件的状态输出或警报。
图4是根据本发明的一个实施方案的独立外科手术中心的初始化和通信建立过程(process)的流程图。该过程可以以储存于存储器(未显示)中的计算机程序指令的形式并且由处理单元301调用来完成。在一些实施方案中,当系统初始化时进行图4的过程。在方框411中,该过程启动或开始向处理单元301供给功率。在一些实施方案中,容纳处理单元的独立外科手术中心10还容纳向处理单元供给功率的功率源315。一些实施方案可能涉及将系统插入外部功率源,例如电插座中。然而,包括内部功率源例如电池的实施方案通常提供更好的机动性。在功率源容纳于系统的盘中的实施方案中,功率源还可以供给抽吸和输注装置307、309功率,并且还可以向连接的手持件提供功率。在独立外科手术中心10以外科手术盘的形式实现的一些实施方案中,一旦盘打开或从其包装中移出,就通过自动开关启动或类似机制启动向独立外科手术中心10的供能。处理单元检测来自功率源的功率并且启动系统。在其它实施方案中,可以设置另外的用户控制开关或控制装置以手动启动功率供应。
在方框413中,该过程检测可能在使用独立外科手术中心的程序的过程中所使用的一个或多个装置或器械。在这方面,该过程调用无线通信界面303例如,诸如射频识别(RFID)读出器,并且自动地询问一个或多个识别标签例如,诸如与一个或多个装置或器械连接或与容纳所述装置或器械的单个或多个的包装连接的RFID标签。RFID标签传送识别信息(例如,装置ID或型号)以及关于各个器械的具体信息,例如,器械类型、构造参数和可用功率设置。在一些实施方案中,某些器械可以包括在包括与具体程序相关的特定外科手术仪器的外科手术包装中。在此实施方案中,包装可以包括识别包装中器械的FRID系统,或备选地,可用器械中的每一个可以包括独立的RFID标签,以便可以更容易地与单独装置中的每一个建立通信。在一些实施方案中,例如关于图2a描述的实施方案,外科手术盘可以包括可以用于各种不同程序的器械。在这些实施方案中,系统可以构造为提供所需程序的选择,并且盘可以识别各个可用器械以确定是否各个器械均用于所需程序。
在方框415中,该过程建立与一个或多个识别的装置的通信。然后所述通信可以用于控制识别的装置的操作和/或接收来自识别的装置的状态信息。根据本发明的一个实施方案,可以不需要与所有识别的装置建立无线通信。例如,该过程可以构造为选择根据用户命令要用于具体程序中的器械,并且建立与那些器械的无线连接,而不是与所有可用器械建立无线连接。在一些实施方案中,在可以在处理单元与选定的器械之间建立通信之前,处理单元首先引导功率源向选定的器械供能。
在方框417中,该过程向已经与其建立通信的装置发送初始配置设置。从各种连接的器械接收的无线数据可以用于例如停止和设置合适的配置(setup),或监测独立外科手术中心自身上的屏幕、与独立外科手术中心连接的外部状态监控器,和/或个人外科手术中心上的外部状态监控器。在一些实施方案中,无线连接还可以用于向一个或多个单独器械传递初始外科手术设置和器械故障参数。在一些实施方案中,各个独立外科手术中心可以预先构造为进行特定程序,并且处理单元301可以基于用于特定程序的预先配置向一个或多个器械发送初始配置设置。在一些实施方案中,个人外科手术中心可以调用读取或输入用户的优先选择或患者数据或统计数据的用户控制器311。在这些实施方案中,初始配置设置代替的是可以基于经由用户控制器提供的更加特定于用户或特定于患者的信息。
图5是根据本发明的一个实施方案以与手持件503通信的外科手术盘505的形式实现的独立外科手术中心的框图。根据此实施方案,手持件是生物组织切割和流体抽吸系统。抽吸线路或管路501将手持件503与盘505连接,用于从外科手术部位吸入不需要的物质。在这方面,该盘包括抽吸室和抽吸装置507,例如,泵或真空。在这些实施方案中,抽吸装置通过抽吸线路501向手持件提供吸入或真空,并且设置储存器或类似的室用于收集通过线路或管路抽吸的物质。抽吸室可以类似于图2b的抽吸室219。
在备选实施方案中,抽吸的手持件可以构造有内部泵和收集室。根据这些备选实施方案,抽吸线路501将不再是必须的,并且手持件和盘之间的连接将是完全无线的。
在图5中示出的实施方案中,除了抽吸装置507以外,该盘还包括处理单元509、功率源511、输注装置513、无线收发机515,和状态指示器517。处理单元509、功率源511、输注装置513、无线收发机515,和状态指示器517可以类似于关于图3描述的处理单元301、功率源315、输注装置309、无线通信界面303,和监控器/LED 305。手持件503包括生物组织切割器519和一套用户控制器521。在本发明的各种实施方案中,盘和手持件中的部件可以不同地安置。还可以有包括没有包括在图5中的各种部件的部件的不同组合,取决于各个系统的应用,它们可能包括在本发明的其它实施方案中。
包括在手持件中的用户控制器521可以例如控制手持件上的切割器的切割速度,或例如,位于盘上的抽吸装置的抽吸水平,或者二者。通常,与系统的特定器械或部件相关的用户控制器位于该特定器械或部件上,从而提供直观的装置-控制器的关联以及系统用户的更容易使用。手持件上的用户控制器可以与处理单元509连接,并且根据处理单元509运行。手持件还可以从处理单元接收另外的指令或操作参数,例如,最大可允许切割速度。切割器519还可以与处理单元通信,例如,用于传递关于当前切割速度的状态信息。此外,图5的功率源511容纳于盘中,从而向盘的部件提供功率。电线523可以从盘连接至手持件,以促进手持件与盘之间的通信,并且向手持件的部件供给功率。
容纳于盘上的抽吸装置507可以是各种不同的抽吸器械中的一种,例如,离心泵,或备选的合适的真空基系统。本发明的一些实施方案可以在手持件上提供用于抽吸装置的控制器,而其它实施方案代替的是可以在盘上提供用于抽吸装置的控制器。本发明的再另外的实施方案可以在与盘处于无线(或有线)通信的另外器械例如脚踏开关上提供用于抽吸装置的控制器。处理单元509从各种控制器中的一个获取抽吸调节要求,并且对抽吸装置507施加调节。调节可以导致抽吸线路的抽吸速率波动,并且因而导致手持件的抽吸速率波动。
容纳在盘上的输注装置513典型地与输出输注线路(未显示)连接。输注装置可以是各种不同输注器械中的一种,例如,哈佛装置注射器泵(Harvard apparatus syringe pump),或例如,弹簧负载注射器(spring loadedsyringe)。输注装置通过输注线路向外科手术部位供给不同流体或气体,具体的流体或气体取决于进行的具体外科手术程序。例如,在玻璃体切割术中,通过输注装置向眼提供无菌平衡盐溶液。在一些实施方案中,输注装置的输注速率可以通过盘的处理单元509基于例如抽吸速率控制。在某些应用中,输注速率可以与抽吸速率同步,以维持外科手术部位处恒定的压力或恒定的容积。在其它实施方案中,盘可以提供一套独立的用于输注速率的用户控制器,从而可以独立于抽吸速率而调节输注速率。
在图5的实施方案中,盘还通过无线收发机515与外科手术系统中的其他器械无线连接。在此实施方案中,盘可以起到控制装置的作用,并且可以用于控制其它器械中的一些或全部的功能。例如,对于玻璃体切割术程序,可能的无线连接装置可以包括:照明装置、脚踏开关和外部监控器。在某些情况下,连接的装置可以用于控制系统的某些方面。例如,脚踏开关可以提供备选的机制来控制系统的切割速度和抽吸水平。在这些情况下,脚踏开关可以向盘无线发送调节命令,在所述盘中,处理单元将调节命令发送至适当的目标。
在其它情况下,用于进行外科手术程序的器械中的一个或多个被独立地控制和操作,并且用于各个器械的用户控制器可以直接设置在器械上。例如,照明装置可以是便携的、自供能的手持LED照明器械或相当的照明装置。与设置在手持件上的切割器控制器类似,可以直接在照明装置上设置照明控制器,以控制操作参数,比如所提供的照明的光强度。在这些情况下,无线连接器械仍可以向盘505传送有用的关于外科手术程序的统计数据、当前设置或状态信息。盘还可以包括显示器、扬声器或其它状态指示器517,用于向系统的用户传达信息。在一些实施方案中,还可以将外部监控器与盘无线连接,并且用于储存汇编的关于外科手术程序的信息。各种器械还可以与盘无线通信,并且彼此通信,以将操作参数最优化。
图6是由根据本发明的一个实施方案的独立外科手术中心的处理单元509、301实施的过程的流程图。在一些实施方案中,图6的过程表示由容纳在图5中的盘中的处理单元进行的过程。在本发明的一些实施方案中,基于处理单元在系统中位于何处,该过程可以在系统的另一个器械或部件中进行。在一些实施方案中,系统可以包括多个处理单元,并且图6的过程可以由多个处理单元中的一个或多个完成。
在方框611中,该过程接收来自与独立外科手术中心通信的器械的信号。在图5中示出的实施方案中,盘505可以通过有线连接接收来自例如图5中示出的手持件503的器械的信号,或可以通过无线连接接收来自例如照明装置的器械的信号。
在方框613中,该过程确定接收的信号是状态更新信号还是调节要求信号。在一些实施方案中,处理单元509、301可以用于调节选定器械的操作参数,还可以用于处理同一器械或其它器械的状态并且将其传达到用户。如果处理单元确定信号是调节要求信号,则过程进行至方框615。如果处理单元确定信号是状态更新信号,则过程代替的是进行至方框619。
在方框615中,该过程确定调节信号所指示的装置。在一些实施方案中,调节信号可以由直接与处理单元连接的用户控制器接收。例如,在图5的实施方案中,调节信号可以来源于控制在处理单元侧面安置于盘中的输注装置的用户控制器。在其它实施方案中,调节信号可以从位于远程器械上的用户控制器例如与盘连接的脚踏开关无线接收。调节要求中的一些可能意欲用于该信号所来源于的装置或部件,而一些其它的调节要求可能意欲用于不同的装置,无论其是盘上的装置或外科手术系统中完全分开的器械上的装置。与调节信号的来源无关,处理单元确定预期目标装置或器械。
在方框617中,该过程向目标装置或器械发送调节命令。取决于系统的配置,调节命令可以是不变的调节信号,其中处理单元起到系统的开关或规划(routing)装置的作用,或调节命令可以是由处理单元基于接收的调节要求信号,例如以上关于方框611所描述的接收的信号所产生的全新命令信号。在系统的大部分实施方案中,在将调节命令发送至各个装置或器械之后,装置的操作设置或参数根据调节命令而调节。
如果信号是状态更新信号,则在方框619中,该过程确定状态更新信号的来源。在大部分实施方案中,状态更新信号包括该状态更新信号所来源于的装置的状态更新信息。状态更新信息可以包括关于来源装置的各种信息,例如,当前设置、操作参数、剩余功率水平、器械故障条件,和其它信息。对于系统中每个特定器械的状态信息根据器械的功能而不同。例如,手持件可以提供切割器的切割速度或抽吸水平的状态,而照明装置可以提供照明水平状态。
在方框621中,该过程更新装置或器械的状态。无论初始接收的信号是调节信号或状态更新信号,系统的处理单元可以更新关于接收的信号的状态信息。在信号是调节信号的情况下,处理单元可以更新调节要求所发送到的目标装置的状态信息。在信号是状态更新信号的情况下,处理单元可以基于状态更新信号的内容直接更新状态更新信号所来源于的装置的状态信息。处理单元可以在例如位于容纳处理单元的器械上的监控器上显示状态更新。备选地,状态更新可以通过例如LED指示器的变化来视觉地表达,或通过例如经由可用扬声器输出的音频警告来听觉地表达。在一些实施方案中,除了容纳处理单元的器械以外,或代替容纳处理单元的器械,视觉或听觉状态指示器可以在系统的各种其它器械上可用。在这些实施方案中,为了输出或用户反馈目的,处理单元可以向适当的器械发送状态更新信息。根据本发明的一个实施方案,将更新信息传输至个人外科手术中心,以记录(log)在外科手术程序产生的记录文件中。在将状态更新应用于系统或由系统记录之后,该过程返回。
图7是根据本发明的各方面的独立外科手术中心的备选实施方案。图7中示出的所述中心可独立于外部操纵台运行,并且起到类似于关于图2b所述的系统的作用。然而,图7的系统不包括起到中央控制单元作用的盘。反而,在图7中,系统包括独立的抽吸/输注盒体701,其包括分离的抽吸室703和输注室705,以及用于每个室的独立装置,例如,抽吸泵或类似装置707和输注泵或类似装置709。盒体与手持件711和输注线路713连接。
根据示出的实施方案,盒体701代替图2b中的盘作为中央控制单元。盒体与外科手术系统的其它外科手术仪器通信。通信通常通过无线连接建立。在这方面,盒体处于与照明装置717和与系统相关的其它装置例如脚踏开关、外部操纵台、和/或各种状态指示器的无线通信715中。在一些实施方案中,手持件和输注线路还可以集成到与盒体701分离的装置中,并且经由无线连接与盒体通信。在这些实施方案中,盒体可以起到在包括手持件和输注线路的装置之间的无线通信媒介的作用。在盒体与外部操纵台通信的实施方案中,盒体通常保持可独立操作,并且监视器典型地起到数据收集和储存装置的作用。在一些实施方案中,外部监视器可能能够例如通过控制系统的选择器械而以更大的能力服务系统。然而,在这些实施方案的大部分中,系统保持在没有外部操纵台的条件下独立起作用。
在图7中示出的实施方案中,盒体被设计成独立式器械。在一些实施方案中,盒体包括背面的突出部分(ledge)721,其允许将盒体悬挂在无菌场内的其它装置例如外科手术盘或Mayo盘上。在一些实施方案中,盒体包括用于控制系统的各种部件和装置,例如可以类似于图3或5的处理单元301、509,用户控制器311、521和功率源315、511的处理单元、用户控制器、功率源723和多个不同的界面装置。界面装置可以包括,例如,抽吸室和用于手持件的端口、输注室和用于输注线路的端口,和与系统的其它器械通信的无线通信界面。功率源向盒体提供功率,并且使得盒体可以独立于其它装置起作用和被供能,而在一些实施方案中,向连接的装置例如手持件提供功率。在一些实施方案中,盒体还可以包括显示器和/或扬声器,它们可以输出各种状态指示器或连接的器械的设置。
在一些实施方案中,独立外科手术中心10和外科手术系统中包括盒体的单个器械一起预先包装在无菌包装中。在这些实施方案中,可以在无菌操作场中将包装打开,并且启动独立外科手术中心10和单个器械,从而给予医师在无菌场内对器械的完全使用和独立外科手术中心10的用户控制。在一些实施方案中,通过启动,盒体可以进行初始扫描以确定可为外科手术程序而与之建立无线通信的可用装置或器械。
根据本发明的一个实施方案,与盒体701连接的手持件711包括生物组织切割器725,并且可以经由流体抽吸线路727与盒体连接。抽吸线路终止于手持件的尖端,并且切割器大约位于尖端处。位于盒体、手持件和/或输注线路上的用户控制器可用于调节系统的抽吸和输注水平。用于其它器械的操作参数,例如照明水平可以通过用于进行各个功能的单独装置直接控制,或备选地,如果在盒体上为用户提供用于其它器械的用户控制器,则可以在盒体处控制。
盒体还可以起到反馈或用户输出系统的作用。盒体可以与各种器械通信以获取状态信息并且将信息传递给系统的用户。在一些实施方案中,信息可以显示在安装在盒体上的内置显示器上。在其它实施方案中,可以结合其它输出或用户反馈手段,例如,显示各种器械的当前参数或状态信息的LED指示器,或当例如触发错误水平时的音频警告。
图8是根据本发明的一个实施方案以图7的输注/抽吸盒体701的形式实现的独立外科手术中心的框图。在许多方面,图8的独立外科手术中心的结构和功能类似于如图5中讨论的所述中心的结构和功能,并且用独立抽吸/输注盒体代替盘而在所述中心中取代。该中心包括与盒体701连接的手持件711。在图8的实施方案中,盒体包括处理单元和用户控制器805、功率源807、抽吸装置809、输注装置811和无线收发机813,而手持件包括生物组织切割器815,以及其本身的无线收发机817和其本身的功率源819。
具有容纳于各个器械中的部件的不同组合允许在不同实施方案之间的操作改变。在图8的实施方案中,例如,手持件中的功率源向手持件中的其余部件提供功率,从而允许手持件独立于盒体而供以功率。因此专用的功率源排除了对在盒体和手持件之间连接的输电线的需要。此外,容纳在手持件中的无线收发机允许手持件与盒体无线通信821,进一步排除了对电线或通信线路如关于图5描述的电线的需要。因此,在图8的实施方案中,在手持件和盒体之间剩余的唯一连接是抽吸线路727,其将抽吸的物质从手持件输送回盒体中的抽吸室。在一些实施方案中,如果另外的抽吸泵和室例如直接位于手持件上或与手持件紧密连接,则手持件可以完全独立于盒体操作。同样,对于系统的其它器械,每个可独立操作的器械包括专用功率源,并且如果需要与处理单元805的通信起到主要控制源的作用,则还可以包括一些无线通信媒介。
在图8的实施方案中,盒体不包括监控器或其它状态指示器。在一些实施方案中,可以没有由独立外科手术中心提供的用于向用户传达状态信息和其它有用系统信息的任何状态指示器。在其它实施方案中,不同类型的状态指示器可以位于远离独立外科手术中心的一个或多个器械上。在这些实施方案中的一些中,位于各个独立器械上的状态指示器可以对应于或另外涉及器械在外科手术系统的上下文中所起的功能。
图9是根据本发明的一个实施方案的独立外科手术中心的又一个备选实施方案的框图。图9可以表示用于图7的中心的可能的备选部件布置。如在图8中观察到和类似描述的,图9示出的实施方案包括与盒体903互连的手持件901。然而,在图9中示出的实施方案中,手持件起到代替盒体作为系统的处理中心的作用。
在图9中示出的实施方案中,手持件包括处理单元和用户控制器905、功率源907、无线收发机909和生物组织切割器911。盒体包括功率源913、抽吸装置915和输注装置917。手持件的处理单元可以起到系统的处理中心的作用,并且与系统的各种器械建立通信,很像如关于图5的盘和图8的盒体所描述的处理单元。备选地,在一些实施方案中,系统的远程器械例如照明装置可以代替地容纳系统的主要处理单元。在图9的实施方案中,为处理单元设置位于手持件中的无线收发机,以与系统的远程器械无线通信。还设置功率源以为手持件提供功率。在一些实施方案中,无线收发机和功率源可以备选地容纳于盒体中,以减小手持件的尺寸并且使其更易于用户操纵。
在图9的实施方案中,盒体起到用于手持件的支持器械的作用。用于抽吸装置和输注装置的用户控制器与处理单元一起位于手持件上,但是可以备选地安置在盒体上。在用户控制器位于手持件上的实施方案中,调节要求可以由手持件上的处理单元处理,而由处理单元产生的调节命令可以发送至盒体上的合适装置。手持件的处理单元还可以控制与手持件无线连接的某些远程装置的操作参数。在许多实施方案中,手持件的处理单元还起到状态更新器的作用,其中由处理单元从各种系统装置接收的状态更新信号经处理单元处理,通过如前所述的各种反馈或输出装置中的任一种传达到系统的用户。
本发明的其它实施方案可以包括各种不同的部件组合和功能差异。例如,手持件可以包括用于监测外科手术部位处抽吸水平的流量传感器,或抽吸传感器或检测器可以改为位于抽吸室处或在抽吸室附近。此外,在一些实施方案中,在手持件处还可以安置抽吸调节器或类似装置例如管夹阀(pinch valve)或类似的可变孔口。可以监测抽吸水平并且通过控制管夹阀或孔口直径来对其进行调节。在这些实施方案中,抽吸室的压力可以保持在恒定水平。还可以将各种其它特征结合到系统的不同器械中。例如,盘或盒体可以包括用于排空抽吸室的端口和/或用于将输注流体或气体填充或再填充到输注室中的端口。可以将许多其它可能特征结合到各个系统中的单独仪器中。
如所述的独立外科手术系统中的不同器械是容易便携的,需要低成本投资,有效率地安装和拆除,使得在手术室内存在较少的人员,可适用于现有的外科手术中心,并且可容易地升级。每个器械可以容易地移动到手术室、外科手术中心和办公室内。医生的办公室是可能进行各种不同程序的新的潜在场所。在医生的办公室中,空间有限,使用大的外科手术仪器可能不总是现实的选择。本发明的高度便携器械使得各种程序的建立更迅速且更便捷,并且可以允许某些程序甚至在医生的办公室中进行。便携式外科手术系统还可以由访问的外科医生使用,并且可以潜在地带到遥远的场所例如经济落后的国家并且在所述遥远的场所中使用。沿着那些相同的线路,所述的仪器还是低成本的。在以上讨论的系统中使用的器械通常全部作为用于一次性使用而设计的一次性单元的形式生产。
此外,系统的建立时间也大大缩短。在本发明的大部分实施方案中,系统初始化和不同器械之间的通信建立是自动的,并且大部分器械构造为立即准备好使用。例如作为在手持件和盘或盒体之间连接的抽吸线路的连接可以在包装之前完成,并且可以为各个系统预先包装输注供给。此外,通常没有要连接的其它线路,并且没有各个单独器械需要与之手动连接的中央操纵台。一旦程序完成,就可以丢弃器械。在一些实施方案中,可以将某些器械例如抽吸和输注泵或装置发回到制造商用于再循环或重新使用。
以下是对可以与独立外科手术中心相分离地起作用的便携式生物组织切割器和输注/抽吸盒的其它实施方案的描述。
生物组织切割和抽吸手持件
根据一个实施方案,生物组织切割和抽吸手持件(例如,玻璃体切割术手持件或其它类似手持件)是便携的、轻便的,且可以由电池供给功率,从而为切割器和/或抽吸供能。其还可以用于现场、办公室、外科手术中心和手术室中。生物组织切割和抽吸手持件可以用作独立器械或与以上讨论的独立外科手术中心结合使用。手持件可以是一次性的,并且与抽吸/输注盒连接,其向切割器提供抽吸压力。图7示出示例性抽吸/输注盒701,其中输注线路713显现于右边而生物组织切割和抽吸手持件显现于左边。盒的左侧起到向生物组织切割和抽吸手持件提供抽吸压力的作用,而右侧提供输注。
例如,在一个实施方案中,生物组织切割和抽吸手持件是一次性的手持件,比如在2007年12月21日提交的标题为一次性玻璃体切割术手持件(Disposable Vitrectomy Handpiece)的同时待审的美国专利申请序号11/963,749中描述的手持件,该美国专利申请的全部内容通过引用结合在此。此外,生物组织切割和抽吸手持件可以结合电池电源和流量控制器/管夹阀。手持件可以与其它外科手术器械、内部或外部监控器或扬声器,或抽吸/输注盒中的控制中心无线通信(例如蓝牙)。备选地,手持件可以与个人外科手术中心无线通信,所述个人外科手术中心如例如在与本申请同日提交的标题为个人外科手术中心(Personal Surgical Center)的美国专利申请中所描述的。外科手术参数(例如切割速度、抽吸压力/流量)可以在手持件上直接控制,或经由与手持件无线连接的脚踏开关控制。这样的参数可以控制切割尖端、抽吸泵等。取决于手持件如何供能(例如,由电池或通过抽吸/输注盒),驱动电路可以直接结合在手持件上、外科手术盘中,或抽吸/输注盒中。
如以上指出的,根据一个实施方案,生物组织切割和抽吸手持件是独立器械,不与外部控制中心一起使用。在此实施方案中,手持件与其它独立仪器如照明装置结合使用。用于手持件的控制器位于手持件自身上,从而消除了对外科手术操纵台的需要。手持件自身或外科手术盘可以具有显示器或扬声器,以告知外科医生当前的外科手术设置和器械故障。根据一个实施方案,手持件包括控制单元和对于图9所描述的其它电路,所述控制单元可以为例如微处理器基单元、ASIC等。
在另一个实施方案中,也如以上所指出的,生物组织切割和抽吸手持件可以与包括控制中心的抽吸/输注盒结合使用,或与外部膝上型电脑控制中心结合使用。尽管可以将系统插入插座中,但电池供能使得手持件具有更好的机动性。电池可以放置在手持件、外科手术盘内,或抽吸/输注盒自身处。当将电池放置在手持件内部时,其增加所述单元的重量和尺寸,从而降低机动性和人体工程学。抽吸/输注盒可以较大和较重,因为对此器械人体工程学并不重要。然而,当电池放置在抽吸/输注盒或外科手术盘处时,需要将电线与抽吸线路一起连接到手持件。
无线控制器(例如蓝牙)可以安装在手持件、抽吸/输注盒、外科手术盘或以上全部中。这依赖于如何构造装置。如果手持件使用电池供能并且不包括与抽吸盒或外科手术盘的连接,则需要在所有单元上安装无线通信。然而,如果在两者之间由直接有线连接,则可以在任一单元上安装无线通信。在一个实施方案中,无线通信将安装在抽吸/输注盒或外科手术盘上,以降低手持件的重量。图5示出其中电池电源为生物组织切割和抽吸手持件供能的系统,无线通信和抽吸全部来源于外科手术盘。
如以上指出的,手持件可以包括用于传递关于器械状态、故障、切割速度等信息的显示器或扬声器。例如,手持件可以包括手持件自身上的LED或扬声器。备选地,器械和操作信息可以在外科手术盘上的显示器或扬声器上指示,或可以显示于膝上型电脑中心(laptop center)。
当与膝上型电脑中心结合使用时,生物组织切割和抽吸手持件可以通过外科手术盘与膝上型电脑直接或间接地通信。膝上型电脑可以显示器械和操作信息,比如当前切割速度、电池寿命(如果可应用的话)和任何故障。其还可以接收其它信息,例如可允许的最大切割速度和其它外科手术参数。在启动时,生物组织切割和抽吸手持件可以向膝上型电脑识别自身并且指明其之前是否被使用过。
如果使用流动感应或流动控制,则传感器和致动器可以接近生物组织切割和抽吸手持件放置,或直接放置在生物组织切割和抽吸手持件上。
抽吸/输注盒
根据一个实施方案,抽吸/输注盒是便携、轻质的,并且连接到生物组织切割和抽吸手持件以及输注线路上。根据一个实施方案,抽吸/输注盒与外科手术盘整体制成,但是根据一个实施方案,盒与盘分离。在后一实施方案中,盒包括可以为例如微处理器基单元、ASIC等的控制单元,以及对于图8描述的允许盒作为对于盒和/或生物组织切割装置的控制中心的其它电路。
该盒可以在现场、办公室、外科中心和外科手术室中使用。盒可以作为独立器械使用,或与外科手术中心例如以上讨论的一种结合使用。备选地,该盒可以与个人外科手术中心结合使用,所述个人外科手术中心如在与本文同日提交的标题为个人外科手术中心(Personal Surgical Center)的同时待审美国申请中所描述的。
抽吸/输注盒包括输注流体(比如BSS)和抽吸线路。向便携式外科手术手持件如上述生物组织切割和抽吸手持件施加抽吸。输注与输注线路连接。在一个实施方案中,抽吸/输注盒包括用于气体-流体交换系统的盒。此外,可以存在允许填充BSS容器(如果需要)或排空抽吸盒的端口。此外,对于某些情况外科医生可以从填充端口放入葡萄糖或其它药物(例如,用于造影的染料)进入输注盒中。
当抽吸/输注盒与个人外科手术中心结合使用时,其与中心分离地供能。尽管可以将系统插入插座电源中,电池电源使得具有更好的机动性。电池可以放置在盒自身中或外科手术盘中,并且为任何真空或输注泵以及生物组织切割和抽吸手持件供能。一旦将盒或外科手术盘从包装中移出就可以接通向盒供能(例如通过开启开关、按钮等)。如果存在个人外科手术中心,则这将启动与其的通信。
在一个实施方案中,抽吸/输注盒是独立的器械。真空源可以直接安装在盒自身上。其可以是类似于文丘里系统的真空基系统,或流动基系统(蠕动泵)。可以使用任何合适的真空基系统,例如,真空源可以由小且电池供能的真空泵组成,从而向手持件提供真空压力。备选地,真空源可以是控制注射器/活塞的电动机或泵以施加真空压力。真空源可以提供恒定真空水平,仅在需要时充电,或其可以允许可变的真空设置。对于流动基真空,向盒增加小的电泵代替蠕动泵。
抽吸/输注盒经由无线连接与个人外科手术中心(当存在时)通信。当没有使用该中心时,该盒可以与其它仪器如生物组织切割器或照明手持件无线通信。
该盒还可以包括预先包装的真空源,其以真空容器的形式装运。要使用就将密封破坏,将真空施加于手持件。然而,如果真空损失,则盒不能被再次装载。
对抽吸的流动控制可以由外科手术手持件控制。流动控制器可以在手柄上或在可以无线连接的脚踏开关上。输注控制器可以在外科手术手持件上、在脚踏开关上,由IV极高度(IV pole height)控制,或通过抽吸/输注盒自身上的开关控制。
在盒处的真空可以是恒定的或可变的。在可变的真空水平控制的条件下,真空水平基于外科手术设置而改变。真空直接与玻璃体切割术抽吸线路连接,并且流动基于真空水平。
如果真空在盒处保持恒定,则可以将管夹阀/可变孔口用于调控流量。在此情况下,在盒中保持全真空并且在基本上所有时间施加于抽吸线路的后面。管夹阀用于调控流量水平。压力传感器可以安装在管夹阀上游(接近生物组织切割和抽吸手持件)。这将以连续方式监测实际压力并且允许精确的管夹阀设置。流量传感器可以代替压力传感器用于测量流率。流量可以通过调节管夹阀来调控。在任一种情况下,脉动(surging)将通过监测接近手持件的流量来降低。对于流动基体系,外科医生将控制真空泵从眼中移出组织的速率。流量可以由盒处或是外科手术器械手持件处的传感器监控。这可以用于关于流动条件的反馈。
输注可以由小的一次性泵(disposable pump)、哈佛型装置机构(Harvardtype apparatus mechamism)、弹簧负载注射器(spring loaded syringe)、小流体泵施加,或通过将单元安装在IV极上施加。为该程序提供预先包装量的无菌平衡盐溶液(BSS)。BSS的体积与抽吸盒的体积相同,或小于抽吸盒的体积。
如果在盒中使用一次性泵,则其可以将盒加压,从而导致BSS进入眼中。可能需要过滤器来保持输注盒内部没有空气中的颗粒。备选地,可以将小的密封输注袋安装到输注线路中。围绕输注线路的室被加压,从而导致输注流体进入眼中并且不与加压的空气发生直接接触。还可以将蠕动泵用于输注眼。备选地,可以将哈佛型装置或弹簧压缩注射器用于输注BSS。
如果使用IV极,则可以从许多不同的IV极设计悬挂盒。此外,可以设计特定IV极以与盒一起工作。在这样的情况下,将存在用于安置盒的位置,并且IV极可以为抽吸泵提供功率。不需要用于维持眼压的输注泵。
如以上指出的,如果使用这样的中心,则抽吸/输注模块可以与个人外科手术中心通信。其将发送关于器械状态的状态信息,并且接收可能改变可操作参数的信息。一旦将抽吸/输注盒开启,则其将与个人外科手术中心通信以表明序列号,是否其以前被用过,和被使用的仪器的类型(25相对于23-标准仪器),正使用哪种玻璃体切割术探针等。盒还可以传达电池的状态和任何可能出现的器械故障。
可以将无线控制器安装在生物组织切割和抽吸手持件、抽吸/输注盒、照明器、外科手术盘,或它们的全部上。这取决于装置如何构造。如果生物组织切割和抽吸手持件使用电池电源并且不与抽吸盒直接连接,则在这两个单元上安装无线通信。如果二者之间有直接的有线连接,则可以在任一个单元上安装无线通信,但是不需要在两个单元上都安装。在一个实施方案中,无线通信安装在盒上以降低手持件的重量。
抽吸/输注盒可以包括用于眼中气体-流体交换的室。这可以是填充有合适气体或气体混合物的注射器。还可以将哈佛型装置、弹簧机构或泵用于管理气体-流体交换。气体线路将与输注线路连接。远程开关可以用于开始气体交换。用于此的按钮可以在照明装置、外科手术盘、生物组织切割和抽吸手持件上,或任何其它合适的场所上。使用的具体气体取决于进行的具体程序。
器械设置、操作参数和状态可以显示在抽吸/输注盒自身上。备选地,此信息可以发送到并且显示于独立外科手术中心、盒、或与盒连接(直接或无线)的个人外科手术中心上。在另一个实施方案中,信息显示在外部监控器上,或通过与盒连接(直接或无线)的扬声器显示。显示的信息可以包括瓶输注压力、用于玻璃体切割术探针的切割速度、故障条件、电池条件和其它操作参数。
盒可以包括在盒背面的突出部分,其允许将盒悬挂在外科手术盘上。备选地,将盒结合到盘中。一个或多个抽吸和输注泵和电池可以与抽吸/输注盒分离,从而允许外科医生在程序之后破坏抽吸和输注盒并且将它们丢弃。可以将泵或电池部件整修然后再次使用。
尽管本发明针对某些具体实施方案进行了描述,但是本领域技术人员将不难于设计出关于毫不偏离本发明的范围和精神的所述实施方案的变型。此外,对于各种领域的技术人员,本文中的发明可以提示对其它任务的解决方案和对其它应用的修改。本申请人的意图是涵盖本发明的所有这样的用途,以及在不偏离本发明的精神和范围的条件下可以对用于公开目的而选择的本文中的本发明的实施方案进行的那些变化和修改。因此,本发明的本实施方案应当认为在所有方面是示例性且非限制性的。
Claims (34)
1.一种用于外科手术程序的独立系统,其包括:
控制装置,其包括处理单元;和
多个器械,其与所述外科手术程序相关且与所述控制装置可操作地连接,
其中将所述控制装置和所述多个器械预先包装在一起,并且将所述处理单元设置为控制所述预先包装的器械中的至少一个。
2.权利要求1所述的系统,其中所述控制装置为外科手术盘。
3.权利要求1所述的系统,其中所述器械是与所述外科手术程序相关的电或气动器械。
4.权利要求1所述的系统,其中所述外科手术程序是眼外科手术程序。
5.权利要求1所述的系统,其中所述外科手术程序包括生物组织切割和流体抽吸。
6.权利要求1所述的系统,其中所述多个电器械中的至少一个包括处理单元。
7.权利要求6所述的系统,其中所述处理单元设置为在所述多个电器械的各个之间建立通信。
8.权利要求7所述的系统,其中所述通信为无线通信。
9.权利要求7所述的系统,其中所述处理单元还设置为:
从所述多个电器械接收状态更新;和
将状态更新传达到所述系统的用户。
10.权利要求6所述的系统,其中所述多个电器械中的至少一个包括用户控制器,所述用户控制器用于调节所述多个电器械中的至少另外一个的操作参数。
11.权利要求6所述的系统,其中所述多个电器械中的至少一个是外科手术盘。
12.权利要求1所述的系统,其中所述多个电器械中的每一个是无菌的,并且可在所述外科手术程序过程中在无菌屏障内使用。
13.权利要求1所述的系统,其中所述多个电器械一起预先包装在无菌包装中。
14.一种外科手术系统,其包括:
便携式外科手术盘,其包括处理单元;
多个器械,其与所述处理单元可操作地连接;和
用户输入装置,其提供用于控制所述多个器械中的一个或多个的操作参数的用户输入,
其中所述处理单元设置为接收所述用户输入并且将操作命令输送至所述多个器械中的一个或多个。
15.权利要求14所述的系统,其中所述多个器械包括生物组织切割器和抽吸装置。
16.权利要求15所述的系统,其中抽吸线路将所述生物组织切割器和抽吸装置连接。
17.权利要求15所述的系统,其中所述多个器械还包括输注装置。
18.权利要求14所述的系统,其中所述多个器械包括照明装置。
19.权利要求14所述的系统,其中控制所述多个器械中的一个的操作参数的所述用户控制器位于所述多个器械中的所述一个上。
20.权利要求14所述的系统,其中所述多个器械包括包含处理单元的外科手术盘,所述处理单元被程序指令设置为:
从所述用户控制器接收调节信号;和
基于所述调节信号调节所述多个器械中的一个的所述操作参数。
21.一种用于外科手术程序的自供能的外科手术系统,其包括:
外科手术盘;
多个手持器械;
功率源,其位于所述外科手术盘和手持器械中的至少一个中;和
处理单元;
其中所述处理单元设置为实施程序指令,所述程序指令包括用于以下各项的指令:
检测来自所述至少一个功率源的功率;
将功率从所述至少一个功率源引导至所述多个手持器械;和
与所述多个手持器械中的每一个建立通信。
22.权利要求21所述的系统,其中所述程序指令还包括用于以下各项的指令:
接收关于所述多个手持器械中的一个的调节要求;和
基于所述调节要求调节所述多个手持器械中的所述一个的操作参数。
23.权利要求22所述的系统,其中从所述多个手持器械中的一个接收每一个调节要求。
24.权利要求21所述的系统,其中所述处理单元容纳在所述外科手术盘中。
25.权利要求24所述的系统,其中在所述外科手术程序之前,将所述多个手持器械和所述至少一个功率源与所述外科手术盘一起包装。
26.权利要求25所述的系统,其中所述包装是无菌的。
27.权利要求26所述的系统,其中所述多个手持器械中的每一个可在所述外科手术程序过程中在无菌屏障内使用。
28.权利要求26所述的系统,其中所述多个手持器械设置为在所述外科手术程序过程中在基本上无菌的屏障内使用,并且还设置为由基本上非无菌的助手使用。
29.权利要求21所述的系统,其中所述多个手持器械中的至少一个与所述外科手术盘物理地连接。
30.权利要求21所述的系统,其中所述程序指令还包括用于以下各项的指令:
从所述多个手持器械中的一个接收状态更新信号;和
基于所述状态更新信号调节与所述多个手持器械中的一个相关的状态指示器。
31.权利要求21所述的系统,其中所述处理单元容纳在所述多个手持器械中的一个中。
32.权利要求21所述的系统,其中所述多个手持器械中的每一个包括射频识别标签以促进与所述处理单元的通信的建立。
33.一种便携式生物切割和抽吸装置,其包括:
切割尖端;
流体抽吸装置;和
集成控制单元,其与所述切割尖端和流体抽吸装置连接,
其中所述控制单元设置为控制所述切割尖端和流体抽吸装置的切割和抽吸。
34.一种便携式输注和抽吸装置,其包括:
抽吸室;
抽吸线路,其与生物组织切割和抽吸装置连接,所述抽吸线路设置为将从外科手术部位移去的物质吸入所述抽吸室中;
输注室,其具有输注溶液;
输注线路,其与所述输注室连接,并且设置为将所述输注溶液注射到所述外科手术部位以维持所述外科手术部位中的压力,
其中所述抽吸室和输注室包括在单个的、一次性盒中。
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PCT/US2008/061058 WO2008131357A1 (en) | 2007-04-20 | 2008-04-21 | Independent surgical center |
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CN101765414B CN101765414B (zh) | 2013-09-25 |
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2008
- 2008-04-21 ES ES12187535.5T patent/ES2621976T3/es active Active
- 2008-04-21 EP EP12187535.5A patent/EP2548537B1/en not_active Not-in-force
- 2008-04-21 CN CN2008800209005A patent/CN101765414B/zh not_active Expired - Fee Related
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- 2008-04-21 EP EP08746468A patent/EP2136746B1/en not_active Not-in-force
- 2008-04-21 ES ES08746468T patent/ES2400538T3/es active Active
- 2008-04-21 EP EP16196682.5A patent/EP3150180B1/en active Active
- 2008-04-21 MX MX2009011163A patent/MX2009011163A/es active IP Right Grant
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2011
- 2011-04-11 US US13/084,471 patent/US8623000B2/en active Active
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2013
- 2013-11-27 US US14/092,159 patent/US9730833B2/en active Active
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2017
- 2017-07-21 US US15/656,171 patent/US10363165B2/en not_active Expired - Fee Related
Cited By (7)
Publication number | Priority date | Publication date | Assignee | Title |
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CN103313670A (zh) * | 2010-11-05 | 2013-09-18 | 伊西康内外科公司 | 具有充电站和无线通信的外科器械 |
CN103313670B (zh) * | 2010-11-05 | 2017-09-01 | 伊西康内外科公司 | 具有充电站和无线通信的外科器械 |
CN102727302A (zh) * | 2011-03-10 | 2012-10-17 | 厄比电子医学有限责任公司 | 具有数字数据接口的外科仪器 |
US9131953B2 (en) | 2011-03-10 | 2015-09-15 | Erbe Elektromedizin Gmbh | Surgical instrument with digital data interface |
CN102727302B (zh) * | 2011-03-10 | 2016-02-03 | 厄比电子医学有限责任公司 | 具有数字数据接口的外科仪器 |
CN104968293A (zh) * | 2013-01-15 | 2015-10-07 | Eos有限责任公司 | 眼科手术设备 |
CN104968293B (zh) * | 2013-01-15 | 2017-07-28 | Eos有限责任公司 | 眼科手术设备 |
Also Published As
Publication number | Publication date |
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EP3150180A1 (en) | 2017-04-05 |
EP2548537A2 (en) | 2013-01-23 |
EP2136746B1 (en) | 2012-12-19 |
WO2008131357A1 (en) | 2008-10-30 |
US8177776B2 (en) | 2012-05-15 |
EP3150180B1 (en) | 2019-06-12 |
US20140323813A1 (en) | 2014-10-30 |
US20170319386A1 (en) | 2017-11-09 |
EP2136746A1 (en) | 2009-12-30 |
MX2009011163A (es) | 2010-04-01 |
EP2136746A4 (en) | 2010-12-22 |
EP2548537B1 (en) | 2017-04-05 |
US20110190690A1 (en) | 2011-08-04 |
US10363165B2 (en) | 2019-07-30 |
US9730833B2 (en) | 2017-08-15 |
US20080281254A1 (en) | 2008-11-13 |
ES2621976T3 (es) | 2017-07-05 |
JP2010524593A (ja) | 2010-07-22 |
ES2400538T3 (es) | 2013-04-10 |
CN101765414B (zh) | 2013-09-25 |
US8623000B2 (en) | 2014-01-07 |
EP2548537A3 (en) | 2013-04-24 |
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