CN101234033A - 具有在控制单元和端部执行器之间通信的元件的外科器械 - Google Patents
具有在控制单元和端部执行器之间通信的元件的外科器械 Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical 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
- A61B17/07207—Surgical 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
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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
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
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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
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00022—Sensing or detecting at the treatment site
- A61B2017/00026—Conductivity or impedance, e.g. of tissue
- A61B2017/0003—Conductivity or impedance, e.g. of tissue of parts of the instruments
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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
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00212—Electrical control of surgical instruments using remote controls
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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
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00221—Electrical control of surgical instruments with wireless transmission of data, e.g. by infrared radiation or radiowaves
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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
- A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
- A61B2017/00398—Details 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00477—Coupling
- A61B2017/00482—Coupling with a code
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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
- A61B2017/00681—Aspects not otherwise provided for
- A61B2017/00734—Aspects not otherwise provided for battery operated
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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
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
- A61B17/072—Surgical 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
- A61B2017/07214—Stapler heads
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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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
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- 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
- A61B90/36—Image-producing devices or illumination devices not otherwise provided for
- A61B90/361—Image-producing devices, e.g. surgical cameras
Abstract
本发明公开了一种具有在控制单元和端部执行器之间通信的元件的外科器械。诸如内窥镜或腹腔镜器械之类的外科器械包括具有近端和远端的轴。所述轴包含第一传感器元件。端部执行器连接到轴的远端上。所述端部执行器包括第二传感器元件。手柄连接到轴的近端上。所述手柄包括控制单元。所述控制单元与第一传感器元件通信,并且所述第一传感器元件与第二传感器元件无线通信。
Description
相关申请的交叉引用
本申请与下列同时提交的美国专利申请相关,这些专利申请的内容通过引用并入本文:
(1)J.Giordano等人的题为“在控制单元和传感器转发器之间进行无线通信的外科器械”(Surgical instrument with wirelesscommunication between control unit and sensor transponders)的美国专利申请(律师档案号060338/END5923USNP);
(2)J.Giordano等人的题为“在控制单元和远程传感器之间进行无线通信的外科器械”(surgical instrument with wirelesscommunication between control unit and remote sensor)的美国专利申请(律师档案号060339/END5924USNP);
(3)F.Shelton等人的题为“对仓重新用在外科器械中的防止”(PREVENTION OF CARTRIDGE REUSE IN A SURGICALINSTRUMENT)的美国专利申请(律师档案号060341/END5926USNP);
(4)J.Swayze等人的题为“外科器械的后消毒程序”(post-sterilization programming of surgical instruments)的美国专利申请(律师档案号060342/END5924USNP);
(5)F.Shelton等人的题为“互锁机构和包含互锁机构的外科器械”(INTERLOCK AND SURGICAL INSTRUMENT INCLUDINGSAME)的美国专利申请(律师档案号060343/END5928USNP);和
(6)F.Shelton等人的题为“具有增强的电池性能的外科器械”(SURGICAL INSTRUMENT WITH ENHANCED BATTERYPERFORMANCE)的美国专利申请(律师档案号060347/END5931USNP)。
技术领域
本发明涉及一种具有在控制单元和端部执行器之间进行通信的元件的外科器械。
背景技术
与传统的开放式外科器械相比,内窥镜外科器械通常更受青睐,这是因为较小的切口易于减少术后恢复时间和并发症。因此,各种内窥镜外科器械已经有了显著的发展,这些器械适于通过套管针的插管将远侧端部执行器精确放置在所需的手术部位。这些远侧端部执行器(例如,内切割器、抓钳、切割器、缝合器、夹具施放器、进入装置、药物/基因治疗输送装置、以及使用超声波、RF、或激光等的能量装置)以各种方式与组织接合,达到诊断或治疗的效果。
已知的外科缝合器包括端部执行器,该端部执行器在组织中形成纵向切口的同时在切口的相对两侧上施加多排缝钉。所述端部执行器包括一对相配合的钳口构件,如果器械用于内窥镜或者腹腔镜应用,这对钳口构件能够穿过插管通道。钳口构件中的一个装纳具有至少两个横向间隔的缝钉排的钉仓。另一个钳口构件限定了具有缝钉成形凹口的钉砧,所述凹口与钉仓中的缝钉排对准。该器械包括多个往复运动的楔形件,这些楔形件在被向远侧驱动时穿过钉仓中的开口并与支撑缝钉的驱动器接合,向着钉砧击发缝钉。
在美国专利No.5465895中描述了适用于内窥镜应用的外科缝合器的例子,其披露了具有不同闭合和击发动作的内切割器。使用该装置的临床医生可在击发之前闭合组织上的钳口构件来定位组织。一旦临床医生确定钳口构件正确地夹持了组织,则临床医生就可用单个击发行程击发外科缝合器,由此缝合和切割组织。同时切割和缝合避免了在使用分别仅仅进行切割或缝合手术的不同外科工具顺序地进行所述动作时引起的并发症。
可在击发之前在组织上闭合的一个具体的优点在于,临床医生可以通过内窥镜确认到达了需要切割的部位,包括确认已经在相对的钳口之间捕获了足量的组织。否则,相对的钳口会被拉得太近,特别是在其远端夹紧,不能在切割的组织中有效成形闭合的缝钉。用于外科缝合器的可多次使用的端部执行器通常是有利的。在另一极端,夹紧过量的组织可导致故障和不完全的击发。
每一代内窥镜缝合器/切割器不断增加复杂性和功能。一个主要的原因是为了满足低击发力(FTF)的要求,使所有或大多数外科医生能够处理。降低FTF的一种已知方案是采用CO2马达或电动马达。这些装置比传统的手动功能装置并不具有明显优势,但原因不同。外科医生通常青睐感受与在成形缝钉时由端部执行器承受的力成比例的分布,以确保切割/缝合周期完成,并且上限在大多数外科医生的能力范围内(通常大约15-30lbs)。他们通常希望保持控制缝钉的展开,并希望能够在感到装置的手柄中的力太大或因为其他一些临床原因随时停止。
为了满足这种需求,已经开发了所谓的“动力辅助”内窥镜外科器械,其中附加的功率源辅助器械的击发。例如,在一些动力辅助设备中,马达向使用者通过按压击发扳机输入的动力提供附加的电功率。这样的设备能够向操作者提供负载力反馈和控制,以减小为了完成切割操作而需要操作者施加的击发力。一种这样的动力辅助设备描述在Shelton等人于2006年1月31日提交的题为“Motor-driven surgical cutting and fastening instrument with loadingforce feedback”(“‘573申请”)的美国专利申请No.11/343573中,通过引用将其包含在这里。
这些动力辅助设备通常包括一些纯机械的内窥镜外科器械所不具有的其他部件,例如传感器和控制系统。在外科器械中使用这些电子器件的一个难题是向传感器输送功率和/或信息并从传感器获取数据,特别是在外科器械中存在自由旋转接头或者关节运动枢轴时。传感器可以用于确定钉仓的状态、使用者输入的负载、内部器械负载、关闭和击发过程中的缝合器进程以及许多其他方面。由此,需要通过使用一个或多个有源和/或无源传感器元件来确定钉仓的状态,其中这些传感器元件不需要动力和/或有线的电连接。
发明内容
在一个总的方面,本发明涉及一种外科器械,例如内窥镜或腹腔镜器械。根据一种实施方式,外科器械包括具有近端和远端的轴。轴包括第一传感器元件。端部执行器连接到轴的远端。端部传感器包括第二传感器元件。手柄连接到轴的近端。手柄包含控制单元。控制单元与第一传感器元件通信,第一传感器元件与第二传感器元件无线通信。
本发明具体涉及如下方面:
(1).一种外科器械,包括:
具有近端和远端的轴,所述轴包含第一传感器元件;
连接到所述轴的远端上的端部执行器,所述端部执行器包括第二传感器元件;和
连接到所述轴的近端上的手柄,所述手柄包括控制单元,其中,所述控制单元与所述第一传感器元件通信,并且所述第一传感器元件与所述第二传感器元件无线通信。
(2).如第(1)项所述的外科器械,其中,所述手柄还包括:
与所述控制单元通信的马达,其中,所述马达用于驱动所述轴中主驱动轴组件,所述主驱动轴组件用于驱动所述端部执行器;和
用于为马达供电的电池。
(3).如第(2)项所述的外科器械,其中,所述手柄还包括:
闭合扳机,用于在通过操作者回缩时使所述端部执行器夹紧定位在所述端部执行器中的物体;和
击发扳机,其与所述闭合扳机分离,用于在通过操作者回缩时使所述马达启动。
(4).如第(1)项所述的外科器械,其中,所述控制单元包括:
发射器;
接收器;和
与所述发射器、所述接收器和第一传感器元件耦合的开关;
其中,所述开关将第一传感器元件耦合到所述发射器,以向所述第二传感器元件发射询问信号;并且
所述开关将第一传感器元件耦合到所述接收器,以响应于所述询问信号来接收由所述第二传感器元件反射的回波响应信号。
(5).如第(4)项所述的外科器械,其中,所述控制单元包括:
与所述接收器连接的处理器,所述处理器用于基于所述回波响应信号来确定所述端部执行器的状态。
(6).如第(1)项所述的外科器械,其中,所述控制单元与所述第一传感器元件无线通信。
(7).如第(1)项所述的外科器械,其中,所述外科器械包括用于使轴旋转的至少一个旋转接头,其中,所述外科器械还包括:
在所述旋转接头的近侧位于所述轴中的第三传感器元件,其与所述第一传感器元件无线通信;和
与所述第三传感器元件通信的第四传感器元件,所述第四传感器元件在所述旋转接头的远侧位于所述轴中,并与所述第二传感器元件无线通信。
(8).如第(7)项所述的外科器械,其中,所述至少一个旋转接头位于所述第三传感器元件和所述第四传感器元件之间。
(9).如第(1)项所述的外科器械,其中,所述轴包括位于所述第一传感器元件和第二传感器元件之间的关节运动枢轴。
(10).如第(1)项所述的外科器械,其中,所述外科器械包括内窥镜外科器械。
(11).如第(1)项所述的外科器械,其中,所述端部执行器包括可动切割器械。
(12).如第(11)项所述的外科器械,其中,所述端部执行器包括钉仓。
(13).一种外科器械,包括:
具有近端和远端的轴;
连接到轴的远端上的端部执行器,所述端部执行器包括传感器元件;和
连接到轴的近端上的手柄,所述手柄包括控制单元,其中,所述控制单元与所述轴通信,并且所述轴与所述传感器元件无线通信。
(14).如第(13)项所述的外科器械,其中,所述手柄还包括:
与所述控制单元通信的马达,其中,所述马达用于驱动所述轴中主驱动轴组件,所述主驱动轴组件用于驱动所述端部执行器;和
用于为所述马达供电的电池。
(15).如第(14)项所述的外科器械,其中,所述手柄还包括:
闭合扳机,用于在通过操作者回缩时使所述端部执行器夹紧定位在所述端部执行器中的物体;和
击发扳机,其与所述闭合扳机分离,用于在通过操作者回缩时使所述马达启动。
(16).如第(13)项所述的外科器械,其中,所述控制单元包括:
发射器;
接收器;和
与所述发射器、所述接收器和所述轴耦合的开关;
其中,所述开关将所述轴耦合到所述发射器,以向所述传感器元件发射询问信号;并且
所述开关将所述轴耦合到所述接收器,以响应于所述询问信号来接收由所述传感器元件反射的回波响应信号。
(17).如第(16)项所述的外科器械,其中,所述控制单元包括:
与所述接收器连接的处理器,所述处理器用于基于所述回波响应信号来确定所述端部执行器的状态。
(18).如第(13)项所述的外科器械,其中,所述外科器械包括内窥镜外科器械。
(19).如第(13)项所述的外科器械,其中,所述端部执行器包括可动切割器械。
(20).如第(19)项所述的外科器械,其中,所述端部执行器包括钉仓。
(21).一种方法,包括:
获得外科器械,其中,所述外科器械包括:
具有近端和远端的轴,所述轴包含第一传感器元件;
连接到轴的远端上的端部执行器,所述端部执行器包括第二传感器元件;和
连接到轴的近端上的手柄,所述手柄包括控制单元,其中,
所述控制单元与第一传感器元件通信,并且所述第一传感器元件与第二传感器元件无线通信;
对所述外科器械进行消毒;以及
将所述外科器械储存在无菌容器中。
附图说明
结合附图通过示例的方式描述本发明的各种实施方式,其中:
图1和2是根据本发明不同实施方式的内窥镜外科器械的透视图;
图3-5是根据本发明不同实施方式的器械的端部执行器和轴的分解图;
图6是根据本发明不同实施方式的端部执行器的侧视图;
图7是根据本发明不同实施方式的器械的手柄的分解图;
图8和9是根据本发明不同实施方式的手柄的局部透视图;
图10是根据本发明不同实施方式的手柄的侧视图;
图11是根据本发明不同实施方式的器械中使用的控制单元的一种实施方式的示意性框图;
图12的示意图示出根据本发明的不同实施方式,控制单元的一种实施方式结合用于外科器械的第一和第二传感器元件的操作;
图13示出包含第一元件的外科器械的一种实施方式,所述第一元件位于外科器械的轴的自由旋转接头部分中;
图14示出包含传感器元件的外科器械的一种实施方式,所述传感器元件布置在外科器械的轴上的不同位置处;以及
图15示出外科器械的一种实施方式,其中外科器械的轴作为用于控制单元的天线的一部分。
具体实施方式
在一种实施方式中,本发明涉及一种外科器械,例如内窥镜或腹腔镜器械。外科器械可以包括轴和手柄,轴的远端与端部执行器相连,轴的近端与手柄相连。手柄可以包括控制单元(例如微控制器),其与第一传感器元件通信。此外,外科器械可以包括用于使轴旋转的旋转接头。在这种情况下,外科器械可以包括第一元件,其位于轴上并在旋转接头的远侧。第一元件可以通过有线或无线电连接来连接到控制单元。第二元件可以位于端部执行器中并通过无线电连接而连接到第一元件。第一和第二元件可以通过有线或无线电连接来连接和/或耦合。
控制单元可以与端部执行器中的第二传感器元件通信,而不需要穿过复杂机械接头的直接有线电连接,这样的机械接头例如旋转接头或关节运动枢轴,这里很难保持这样的有线电连接。此外,因为感应元件之间的距离可以是固定的并且是公知的,所以第一和第二传感器元件之间的耦合可以针对能量的感应和/或电磁转换而最优化。此外,该距离可以相对较短,以使相对低功率的信号可以用于最小化与器械使用环境中的其他系统之间的干扰。
在本发明的另一种实施方式中,外科器械的导电轴可以用作控制单元的天线,以向一个或多个传感器元件无线传输信号并从其接收信号。例如,一个或多个传感器元件可以位于或者设置在端部执行器的绝缘部件上,例如塑料仓上,由此使传感器元件从端部执行器的导电部件和轴绝缘。此外,手柄中的控制单元可以电连接到轴。以该方式,轴和/或端部执行器可以用作控制单元的天线,以将信号从控制单元辐射到一个或多个传感器元件和/或从一个或多个传感器元件接收辐射的回波响应信号。这样的设计在具有负载的机械接头(例如旋转接头)和关节运动枢轴的外科器械时特别有用,这些负载的机械接头和关节运动枢轴使得很难在传感器元件和控制元件之间使用直接的有线电连接以在它们之间传输电信号。
本发明的各种实施方式整体上涉及一种外科器械,其包括一个或多个传感器来感测布置在外科器械上的各个使用部件的位置、类型、存在性和/或状态。在一种实施方式种,本发明整体上涉及一种外科器械,其具有一个或多个传感器来感测布置在外科器械的端部执行器部分中的各个使用部件的位置、类型、存在性和/或状态。这些使用部件例如可以包括滑块、钉仓、切割器械或任何其他部件,它们可以布置在外科器械上,特别是布置在其端部执行器部分中。尽管本发明可以与诸如内窥镜或腹腔镜外科器械之类的任何类型外科器械一起使用,但是对于包括一个或多个自由旋转接头或关节运动枢轴的外科器械来说特别有用,这些自由旋转接头或关节运动枢轴使得很难对一个或多个有源和/或无源传感器元件使用有线电连接。
所述一个或多个传感器元件可以是适于以任何合适的方式与控制单元进行通信的有源或无源传感器元件。在各种实施方式中,一些传感器元件可以不通过有线电连接来供应功率,并且如这里所述,有源和无源传感器元件可以都不包含内部电源。通过引入由控制单元发射的射频(RF)询问信号,传感器元件可以使用在传感器元件自身或连接到传感器元件上的天线中感应产生的微电流提供的功率来操作。这意味着天线和/或传感器元件自身可以被设计为从引入的询问信号聚集功率,并响应于此传输向外的反向散射信号。没有机载电源意味着传感器元件可以具有相对小的形状因子。在包含无源传感器元件的实施方式中,RF询问信号可以由无源传感器元件通过预定的通道无线地接收。然后,与RF询问信号相关的附带电磁辐射被散射或者反射回诸如控制单元之类的询问源。由此,无源传感器元件信号的散射和反射是通过反向散射来自控制单元的RF询问信号的载波信号来实现的。另一方面,在包含有源传感器元件的实施方式中,可以从RF询问信号接收足够的功率,以使有源传感器元件加电并响应于RF询问信号而将模拟或数字信号传输回到控制单元。控制单元可以是读数器、询问器等。
在一种实施方式中,位于外科器械端部执行器部分中的部件(例如滑块、钉仓、切割器械)的状态可以通过使用包括与控制单元相连的有源和/或无源传感器元件的系统来确定。无源传感器元件可以由无源硬件元件(例如阻抗、感应和/或电容元件或其任意组合)构成或者包含上述的无源硬件元件。有源传感器元件可以由有源硬件元件构成或者包含有源硬件元件。这些有源硬件元件可以是集成的和/或分立的电路元件或其任意组合。集成的和/或分立的硬件元件的示例如下所述。
在一种实施方式中,系统可以包括:在关节运动枢轴(如下所述)之前与主传感器元件(主元件)相连的控制单元,所述的主传感器元件布置在外科器械的轴的远端处;和在关节运动枢轴之后定位的副传感器元件(副元件),该副传感器元件布置在外科器械的端部执行器部分中的使用部件上(例如在如下所述的滑块上)。不同于通过有线电连接向副元件传输连续的功率,主元件通过以预定的频率、周期和重复率经过通道传输电磁脉冲信号来无线地触发或者辐射副元件。当触发脉冲信号入射(也就是撞击或者辐射)副元件时,器产生回波响应信号。回波响应信号是入射在副元件上的电磁能的反射。在传输询问信号之后,主元件接收从副元件反射的回波响应信号,并以适当的形式将回波响应信号耦合到控制单元,用于随后的处理。回波响应信号的频率可以与触发脉冲的频率或者与其一些谐波频率相同。回波响应信号中反射能量的量依赖于副元件的材料、形状和尺寸。回波响应信号中反射能量的量还依赖于主元件和副元件之间的距离。因此,可以选择副元件的材料、形状和尺寸以及主元件和副元件之间的相对距离,以产生唯一的回波响应信号,其表示与连接到副元件的使用部件相关的所需测量。例如,唯一的回波响应信号可以表示设置在外科器械中的各个部件以及子部件的位置、类型、存在性和/或状态。特别地,在自由旋转接头或关节运动枢轴之后在外科器械端部执行器部分中布置各个部件和子部件使得很难或者实践中不能在主元件和副元件之间提供有线电连接。回波响应信号也可以用于确定主元件和副元件之间的距离。以此方式,副元件可以与使用部件形成一体或者连接到使用部件,并且回波响应信号可以提供与使用部件相关的信息。这种布置可以消除通过有线连接来向副元件传输或提供功率的需要,并可以针对在外科器械中提供各种附加的有源和/或无源传感器元件而成为一种节约成本的方案。在描述系统的各个方面之前,首先通过示例的方式来描述可以使用本发明的一种外科器械——内窥镜缝合和切割器械(也就是内切割器)。
图1和2示出了内窥镜外科器械10,内窥镜外科器械10包括手柄6、轴8和在关节运动枢轴14处枢转连接到轴8上的关节运动端部执行器12。可以通过对手柄6的控制来辅助端部执行器12的正确定位和定向,手柄6包括(1):旋钮28,用于在轴8的自由旋转接头29处旋转闭合管(以下将结合图4-5更详细地描述)以旋转端部执行器12和(2)关节运动控制器16,以实现端部执行器12绕关节运动枢轴14的旋转关节运动。在所示的实施方式中,端部执行器12能够用作内切割器,用于夹紧、切割和缝合组织,但是在其他实施方式中,可以使用其他类型的端部执行器,例如用于其他类型的外科装置的端部执行器,如抓钳、切割器、缝合器、夹具施放器、接入装置、药物/基因治疗输送装置、超声、RF、或激光装置等。
器械10的手柄6可包括闭合扳机18和击发扳机20,用于致动端部执行器12。应当理解,具有用于不同手术任务的端部执行器的器械可具有不同数量和类型的扳机或者其他适合的控制器,用于操作端部执行器12。所示的端部执行器12通过优选的细长轴8与手柄6分离。手柄可以包括通过电连接23与第一元件21通信的控制单元300(下述)。电连接23可以是诸如导电胶包线之类的有线电连接或者可以是无线电连接。导电胶包线可以由导电聚合物和/或金属(例如铜制成),并可以足够柔韧使得其能够穿过关节运动控制器16、旋钮28、自由旋转接头29以及器械10的手柄6中的其他部件,而不会由于旋转而受到损坏。第一元件21可以在关节运动枢轴14之前布置在轴8的远端处。第二元件35(以下如图3所示)可以布置在关节运动端部执行器12中并与第一元件21无线通信。第一和第二元件21、25以及控制单元300的操作如下所述。在一种实施方式中,器械10的临床医生或者操作者可以通过利用关节运动控制器16使端部执行器12相对于轴8关节运动,如Geoffrey C.Hueil等人2006年1月10日提交的名称为“Surgical Instrument Having An ArticulatingEnd Effector”的待审美国专利申请No.11/329020中更详细地描述的一样,该申请通过引用并入本文。
在该示例中,除了别的以外,端部执行器12包括缝钉通道22和可枢转平移的夹紧构件如钉砧24等,它们之间保持确保有效缝合和切割夹紧在端部执行器12中的组织的间距。手柄6包括手枪式握把26,临床医生向着手枪式握把26枢转地拉动闭合扳机18,使钉砧24朝着端部执行器12的缝钉通道22夹紧或者闭合,从而夹紧定位在钉砧24和缝钉通道22之间的组织。击发扳机20在闭合扳机18更远的外侧。一旦闭合扳机18锁定在闭合位置,击发扳机20可朝着手枪式握把26稍微转动,从而操作者可用一只手触及。然后操作者可以向着手枪式握把26枢转地拉动击发扳机20,从而缝合和切割端部执行器12中夹紧的组织。‘573申请描述了用于锁定和解锁闭合扳机18的各种构造。在其他实施方式中,可以使用除钉砧24之外的不同类型的夹紧构件,例如,相对的钳口等。
应当理解,此处使用的术语“近侧”和“远侧”是相对于握持手柄6的临床医生而言。因此,相对于更近侧的手柄6而言,端部执行器12位于远侧。还应当理解,为了方便和清楚起见,使用的空间术语例如“垂直”和“水平”是相对附图而言。但是,可以多种方位和位置使用外科器械,这些术语并不意味着限制和绝对化。
可以首先致动闭合扳机18。一旦临床医生对端部执行器12的定位满意,医生可将闭合扳机18拉回到邻近手枪式握把26的其完全闭合的锁定位置。然后致动击发扳机20。当医生从击发扳机20移除压力时,击发扳机20返回打开位置(图1和2所示)。按压手柄6(在该示例中是手柄的手枪式握把26)上的释放按钮30时可释放锁定的闭合扳机18。
图3是根据不同实施方式的端部执行器12的分解图。如图示实施方式所示,除了前面描述的通道22和钉砧24之外,端部执行器12还可包括切割器械32、滑块33、钉仓34以及螺旋轴36,钉仓34可移除地安置于通道22中。第二元件35可以与使用部件连接或者与其一体形成。切割器械32例如可以使小刀。钉砧24可以在连接到通道22的近端上的枢转点25处可枢转地打开和闭合。钉砧24还可在近端包括突起27,突起27插入机械闭合系统(下面将进一步描述)的部件中,以打开和关闭钉砧24。当致动闭合扳机18时,即当器械10的用户拉动闭合扳机18时,钉砧24可以围绕枢转点25枢转到夹紧或者闭合位置,如果端部执行器12的夹紧是满意的,操作者可致动击发扳机20(下面将更详细地描述),使得刀32和滑块33沿着通道22纵向运动,由此切割夹紧在端部执行器12中的组织。滑块33沿着通道22的运动使得钉仓34的缝钉被驱动通过切割的组织,靠在闭合的钉砧24上,使得缝钉紧固切割的组织。名称为“Surgical stapling instrument incorporating an E-beam firingmechanism”的美国专利No.6,978,921更详细地描述了这种双行程式切割和紧固器械,该专利通用引用并入本文。可以包含第二元件35的滑块33可以是钉仓34的部件,使得当刀32在切割操作后缩回时,滑块33和第二元件35不会缩回。仓34可以由非导电材料(例如塑料)制成。在一种实施方式中,第二元件35例如可以连接到仓34或者布置在仓34中。在所示的实施方式中,第二元件35可以以任何合适的方式连接到滑块33或者其任意合适的部位上。在其他实施方式中,第二元件35可以嵌入在滑块33中或者以其他方式与滑块33一体地形成。由此,滑块33的位置可以通过检测第二元件35的位置来确定。第二元件35可以由各种尺寸和形状的各种材料形成,并且可以位于距离第一元件21预定距离的位置处,以使控制单元300能够确定钉仓34的类型、存在性和状态。
应当注意,尽管这里描述的器械10的实施方式采用缝合切割的组织的端部执行器12,在其他实施方式中可以采用其他技术来紧固或者密封切割的组织。例如,也可采用利用RF能量或者粘结剂来紧固切割的组织的端部执行器。Yates等人的名称为“ElectrosurgicalHemostatic Device with Recessed and/or Offset Electrodes”的美国专利No.5,688,270和Yates等人的名称为“Electrosurgical HemostaticDevice”的美国专利No.5,709,680披露了利用RF能量来紧固切割的组织的切割器械,这两篇专利通过引用并入本文。Morgan等人的美国专利申请No.11/267,811和Shelton等人的美国专利申请No.11/267,363公开了采用粘结剂来紧固切割的组织的切割器械,这两篇申请通过引用并入本文。因此,尽管这里的描述涉及切割/缝合操作和下面的类似操作,应当理解,这只是示例性的实施方式,并不因为这限制。可采用其他组织紧固技术。
图4和5是根据各个实施方式的端部执行器12和轴8的分解视图,而图6是其侧视图。如图示的实施方式所示,轴8可包括由枢转连接件44枢转连接的近侧闭合管40和远侧闭合管42。远侧闭合管42包括开口45,钉砧24上的突起27插入该开口45,以打开和闭合钉砧24。近侧脊管46可设置在闭合管40、42内。主旋转(或近侧)驱动轴48可设置在近侧脊管46内,驱动轴48通过锥齿轮组件52与第二(远侧)驱动轴50连接。在图示的实施方式中,第一元件21可以是绕近侧脊管46设置的线圈(如图4和5所示)。在有线电连接构型中,第一元件21可以通过有线电连接23连接到控制单元300,有线电连接23可以包含长度足以形成线圈的导线。导线的长度可以沿着近侧脊管46设置,以连接至控制单元300。在无线电连接构型中,导线不是必需的,并且电连接23至控制单元300是无线电连接诶。在一种实施方式中,第一元件21可以容纳在近侧脊管46中(例如图6所示)。在其他情况下,第一元件21与近侧机关46电绝缘。
第二驱动轴50连接到驱动齿轮54上,驱动齿轮54接合螺旋轴36的近侧驱动齿轮56。垂直锥齿轮52b可安座于近侧脊管46的远端的开口57中,并可在该开口57中枢转。远侧脊管58可用于装纳第二驱动轴50和驱动齿轮54、56。主驱动轴48、第二驱动轴50和关节运动组件(例如锥齿轮组件52a-c)有时整体称作“主驱动轴组件”。主驱动轴组件的部件(例如驱动轴48、50)可以由绝缘材料(例如塑料)制成。
位于钉通道22远端的轴承38接收螺旋传动螺杆36,允许螺旋传动螺杆36相对于通道22自由旋转。螺旋轴36可以与刀32的螺纹开口(未示出)互相作用,使得轴36的旋转引起刀32向远侧或近侧(根据旋转的方向)移动穿过钉通道22。由此,当主驱动轴48由于击发扳机20的致动而旋转时(如下更详细的描述),锥齿轮组件52a-c使第二驱动轴50旋转,由于驱动齿轮54、56的接合,这又使得螺旋轴36旋转,这引起刀32沿着通道22纵向移动,以切割夹在端部执行器中的任何组织。滑块33可例如由塑料制成,并可具有倾斜的远侧表面。如前所述,第二元件35可以以任何合适的方式连接到滑块33上,以确定滑块33和/或钉仓34的状态、位置和类型。当滑块33横过通道22时,倾斜向上的表面可向上推动或驱动钉仓中的缝钉通过夹紧的组织,靠在钉砧24上。钉砧24转动缝钉24,由此缝合切割的组织。当刀32缩回时,刀32和滑块33可脱离接合,由此使滑块33留在通道22的远端。
根据各种实施方式,如图7至10所示,外科器械可以在手柄6中包含电池64。图示的实施方式提供了有关端部执行器12中的切割器械的展开和加载力的用户反馈。另外,该实施方式可采用用户在缩回击发扳机20时提供的能量,以对器械10驱动(所谓的动力辅助模式)。如该示例性实施方式所示,手柄6包括外部下侧件59、60和外部上侧件61、62,它们相互配合整体上形成手柄6的外部。手柄件59-62可以由电绝缘材料例如塑料制成。电池64可设置在手柄6的手枪式握把26中。电池64对设置在手柄6的手枪式握把26的上部中的马达供电。电池64可以根据任何合适的结构或者化学方式来构造,例如包括诸如LiCoO2或LiNiO2之类的Li离子化学电池、镍金属氢化物化学电池等。根据不同实施方式,马达65可以是DC电刷驱动马达,其最大转速为大约5000至100000RPM。马达可驱动包括第一锥齿轮68和第二锥齿轮70的90°的锥齿轮组件66。锥齿轮组件66可驱动行星齿轮组件72。行星齿轮组件72可包括连接到驱动轴76上的小齿轮74。小齿轮74可驱动相配合的环形齿轮78,环形齿轮78通过驱动轴82驱动螺旋齿轮鼓80。环84可拧入螺旋齿轮鼓80。因此,当马达65转动时,通过中间夹设的锥齿轮组件66、行星齿轮组件72和环形齿轮78使环84沿着螺旋齿轮鼓80运动。
手柄6还可包括与击发扳机20连通的运转马达传感器110,当操作者朝着手柄6的手枪式握把26拉近(或者“关闭”)击发扳机20时,运转马达传感器110进行检测,由此通过端部执行器12致动切割/缝合操作。传感器110可以是比例传感器,例如变阻器或者可变电阻器。当拉近击发扳机20时,传感器110检测运动并发出供给马达65的表现为电压(或动力)的电信号。当传感器110时可变电阻器等时,马达65的转速可以与击发扳机20的运动量大致成比例。也就是说,如果操作者仅轻微拉动或者关闭击发扳机20,马达65的转速较低。当完全拉近击发扳机20(或者出于完全关闭位置),马达65的转速为其最大值。换句话说,用户越用力拉动击发扳机20,施加到马达65上的电压越多,产生更大的转速。
手柄6可包括位于击发扳机20的上部附近的中间手柄件104。手柄6还可包括偏压弹簧112,其连接在中间手柄件104上的柱和击发扳机20上的柱之间。偏压弹簧112可将击发扳机20偏压到其完全打开位置。这样,当操作者释放击发扳机20时,偏压弹簧112将击发扳机20拉到其打开位置,由此释放传感器110的致动,从而停止马达65的转动。此外,借助于偏压弹簧112,每当用户关闭击发扳机20时,用户会感到关闭操作的阻碍,由此提供给用户有关马达65转动量的反馈。另外,操作者可停止缩回击发扳机20,以从传感器110移除力,由此停止马达65。同样,用户可停止展开端部执行器12,由此为操作者提供对切割/紧固操作的控制的测量。
螺旋齿轮鼓80的远端包括驱动环形齿轮122的远侧驱动轴120,该环形齿轮122与小齿轮124啮合。小齿轮124连接到主驱动轴组件的主驱动轴48上。这样,马达65的转动使得主驱动轴组件转动,从而致动端部执行器12,如上面所描述的一样。
拧入螺旋齿轮鼓80的环84可包括设置在带槽臂90的槽88中的柱86。带槽臂90的相对端部94具有开口92,装纳连接在手柄外侧件59、60之间的枢轴销96。枢轴销96还穿过通过击发扳机20中的开口100和中间手柄件104中的开口102。
另外,手柄6可包括反转马达(或行程结束)传感器130和停止马达(行程开始)传感器142。在不同实施方式,反转马达传感器130可以是位于螺旋齿轮鼓80远端的限制开关,使得当环84到达螺旋齿轮鼓80的远端时拧入螺旋齿轮鼓80的环84接触和脱扣反转马达传感器130。反转马达传感器130在启动时对控制单元发送信号,控制单元发动信号至马达65,以倒转其转动方向,由此在切割操作之后缩回端部执行器12的刀32。
停止马达传感器142例如可以是常闭限制开关。在不同实施方式中,停止马达传感器142可以位于螺旋齿轮鼓80的近端,使得当环8 4到达螺旋齿轮鼓80的近端时环84断开(trip)开关142。
手柄6还可以包含控制单元300。控制单元300可以通过电池64用附加的调节电路(未示出)来供电。控制单元300通过电连接23连接到第一元件21。如前所述,电连接23可以是无线电连接或者有线电连接。
在操作中,当器械10的操作者拉回击发扳机20时,传感器110检测击发扳机20的展开并对控制单元发送信号,控制单元向马达65发送信号,使得马达65例如以与操作者拉回击发扳机20所用力的程度成比例的速度向前旋转。马达65的向前旋转又使得行星齿轮组件72远端的环形齿轮78旋转,由此使得螺旋齿轮鼓80转动,从而使拧入螺旋齿轮鼓80的环84沿着螺旋齿轮鼓80向远侧运动。螺旋齿轮鼓80的转动还驱动如上所述的主驱动轴组件,这又使得端部执行器12中的刀32展开。也就是说,使得刀32和滑块33纵向运动经过通道22,由此切割夹紧在端部执行器12中的组织。此外,在使用缝合式端部执行器的实施方式中使端部执行器12产生缝合操作。
当端部执行器12的切割/缝合操作完成时,螺旋齿轮鼓80上的环84到达螺旋齿轮鼓80的远端,由此使反转马达传感器130断开,对控制单元发送信号,控制单元向马达65发送信号以使马达65倒转其转动方向。这使得刀32缩回,从而使螺旋齿轮鼓80上的环84运动回到螺旋齿轮鼓80的近端。
如图8和9中最清楚地显示的一样,中间手柄件104包括后侧肩部106,后侧肩部106接合带槽臂90。中间手柄件104还具有接合击发扳机20的向前运动挡块107。带槽臂90的运动如上所述受马达65的转动控制。当环84从螺旋齿轮鼓80的近端朝远端运动时,在带槽臂90逆时针转动(CCW)的情况下,中间手柄件104自由逆时针转动。因此,当用户拉近击发扳机20时,击发扳机20接合中间手柄件104的向前运动挡块107,使得中间手柄件104逆时针转动。由于后侧肩部106接合带槽臂90,中间手柄件104仅能够在带槽臂90允许的范围内逆时针转动。这样,如果马达65由于一些原因停止转动,带槽臂90也会停止转动,用户就不能进一步拉近击发扳机20,因为带槽臂90使得中间手柄件104不能自由逆时针转动。
图7-10还显示出了用于通过缩回闭合扳机18闭合(或夹紧)端部执行器12的钉砧24的示例性闭合系统的部件。在该示例性实施方式中,闭合系统包括轭250,其通过销251连接到闭合扳机18上,销251通过闭合扳机18和轭250中对准的开口插入。枢轴销252通过闭合扳机18中的另一个孔插入,该孔偏离销251插入闭合扳机18中的那个孔,闭合扳机18围绕枢轴销252枢转。这样,闭合扳机18的缩回使得闭合扳机18的上部逆时针转动,轭250通过销251连接到闭合扳机18的所述上部上。轭250的远端通过销254连接到第一闭合支架256上。第一闭合支架256连接到第二闭合支架258上。闭合支架256、258整体限定了一个开口,近侧闭合管40(参见图4)的近端安座并保持在该开口中,从而闭合支架256、258的纵向运动使得近侧闭合管40纵向运动。器械10还包括设置在近侧闭合管40内的闭合杆260。闭合杆260可包括窗口261,手柄外部件中的一个(例如该示例性实施方式中的外部下侧件59)上的柱263设置在窗口261中,以将闭合杆260固定地连接到手柄6上。这样,近侧闭合管40能够相对于闭合杆260纵向运动。闭合杆260还可包括远侧轴环267,轴环267装配到近侧脊管46的腔269中并通过帽271(参见图4)保持在其中。
在操作中,当由于闭合扳机18缩回使得轭250转动时,闭合支架256、258使近侧闭合管40向远侧(远离器械10的手柄端部)运动,这使得远侧闭合管42向远侧运动,从而使钉砧24围绕枢转点25转动到夹紧或者闭合位置。当闭合扳机18从锁定位置解锁时,使近侧闭合管40向近侧滑动,这又通过插在远侧闭合管42的窗口45中的突起27使得远侧闭合管42向近侧滑动,从而使钉砧24围绕枢转点25转动到打开或者松开位置。这样,通过缩回和锁定闭合扳机18,操作者可夹紧钉砧24和通道22之间的组织,并且可以在切割/缝合操作之后通过从锁定位置解锁闭合扳机18来松开组织。
控制单元300(以下进一步描述)可以接收来自行程结束传感器和行程开始传感器130、142以及马达运行传感器110的输出,并可以基于输入来控制马达65。例如,当操作者在锁定闭合扳机18之后首次拉击发扳机20时,马达运行传感器110被启动。当钉仓34存在于端部执行器12中时,仓锁定传感器(未示出)可以接通,在这种情况下,控制单元可以向马达65输出控制信号以使马达65在向前方向上旋转。当端部执行器12到达其行程末端时,反转马达传感器130被启动。控制单元可以从反转马达传感器130接收该输出并使马达65的转向反向。当刀32完全回缩时,停止马达传感器开关142启动,使得控制单元停止马达65。
在其他实施方式中,可以使用开-关式传感器而不是比例式传感器110。在这些实施方式中,马达65的转动速度与操作者施加的力不成比例。马达65是以恒定的速度转动。但是操作者还是感到力的反馈,因为击发扳机20连接在齿轮传动系统中。
器械10可以在端部执行器12中包括大量传感器元件,用于感测与端部执行器12相关的各种状态,例如用于确定钉仓34(或者根据外科器械的类型而变化的其他类型的仓)的状态的传感器元件、在闭合和击发过程中用于确定缝合器进程的传感器元件等。传感器元件可以通过感应耦合信号来无源地驱动,如J,Giordano等人的共同转让的题为“在控制单元和传感器转发器之间进行无线通信的外科器械(Surgical Instrument With Wireless Communication BetweenControl Unit and Sensor Transponders)”美国专利申请(律师案卷号No.060338/END5923USNP)中所描述的,通过引用将其包含在这里。在其他实施方式中,传感器元件反射或者散射入射的电磁能或者响应于询问信号而加电,并发射可以被耦合回到控制单元300用于进行处理的回波响应脉冲或信号。在其他实施方式中,通过引入由控制单元300发射的入射电磁能(例如询问信号的RF载波),传感器元件可以由在连接到传感器元件上的传感器元件自身或天线中感应的微电流来驱动。这些传感器元件可以包括任意布置的电导体,以传输、接收、放大、编码、散射和/或反射任意合适预定频率的电磁波能量(例如波长为λ),该电磁波能量具有可以在合适的预定周期上被传输的合适预定脉冲宽度。无源传感器元件可以包括电阻元件、感应元件和/或电容元件的任何合适的布置。有源传感器元件可以包括半导体,例如晶体管、集成电路、处理器、放大器或这些有源元件的任意组合。为了简洁,无源和/或有源传感器元件以下被称作第一元件21和第二元件35。第一元件21可以与控制单元300有线或无线通信,如前所述,控制单元300例如可以容纳在器械10的手柄6中,如以下的图11所示。第一元件21与第二元件35无线通信。
图11图示了控制单元300的一种实施方式的示意性框图。根据不同的实施方式,控制单元300可以包括处理器306以及一个或多个存储器单元308。基于从一个或多个端部执行器传感器元件和/或穿过器械10定位的其他传感器元件(例如马达运行传感器110、行程结束传感器130和程开始传感器142)接收的输入,通过执行储存在存储器308中的指令代码,处理器306可以控制器械10的不同部件,例如马达65或显示器(未示出)。在器械10的外科使用过程中,可以通过电池64来驱动控制单元300。控制单元300可以通过电连接23连接到第一元件21,并可以与第二元件35通信,如下更详细地描述。控制单元300可以包括发射器320和接收器322。第一元件21可以连接到发射器320以输出询问信号,或者可以连接到接收器322以根据开关324的操作来接收回波响应信号。
开关324可以在处理器306、发射器320或接收器322或其任意组合的控制下进行操作,以将控制单元300置于接收器模式或者发射器模式。在发射器模式下,开关324将第一元件21耦合到发射器320并且由其第一元件21作为发射天线。编码器316编码带传输的输出询问信号,该信号然后由调制器318进行调制。连接到调制器318上的振荡器326设定用于带传输输出信号的操作频率。在接收器模式下,开关324将第一元件21耦合到接收器322。由此,第一元件21作为接收天线并从其他传感器元件(例如第二元件35)接收输入信号。接收的输入信号可以通过解调器310来解调并通过解码器312来解码。输入信号可以包括来自一个或多个传感器元件(例如第二元件35)的回波响应信号。回波响应信号可以包括与位于端部执行器12中或者位于器械10中其他位置的各个部件的位置、类型、存在性和/或状态相关的信息。回波信号例如可以包括由第二元件35反射的信号,第二元件可以连接至滑块33,位于端部执行器12中的钉仓34或任何其他部件可以位于器械10的任意部分上的任何使用部件上。从第二元件35反射的回波信号数据可以被处理器306使用,以控制器械10的各个方面。
为了将输出信号从第一元件21传输到第二元件35,控制单元300可以使用用于编码输出信号的编码器316和用于根据预定的调制方案来调制输出信号的调制器318。如前所述,在发射器模式下,第一元件21通过开关324连接至发射器320并作为发射天线。编码器316可以包括定时单元,从而以预定的合适脉冲重复频率来产生定时脉冲。这些定时脉冲可以施加至调制器318,从而以精确并且规则的时间间隔来触发发射器。由此,在一种实施方式中,调制器318可以产生已知脉冲宽度的矩形脉冲,以开关振荡器326。根据调制方案,振荡器326产生由振荡器326设定的预定功率和频率(或波长λ)的短宽度脉冲。脉冲重复频率可以由编码器312来确定,脉冲宽度可以由调制器318来确定。针对各个输出脉冲的宽度,开关324在控制单元300的控制下自动将发射器320连接至第一元件21。在发射器模式下,第一元件21辐射发射器320的输出脉冲信号,并拾取或者检测反射的回波信号,用于应用至接收器322。在接收器模式下,根据发射脉冲之间的间隔,开关324将第一元件31连接至接收器322。接收器322接收传输的脉冲输出信号的回波信号,该信号可以从位于器械上的一个或多个传感器元件(例如连接至滑块33的第二元件35)反射。接收器322放大回波信号并以合适的方式将其送至解调器310。接下来,解调的回波信号被提供至解码器312,在这里,用传输的输出脉冲信号来关联这些解调的回波信号,以确定位于端部执行器12中的各个部件的位置、类型、存在性和/或状态。此外,可以确定第一和第二元件21、35之间的距离。
控制单元300可以使用任何合适的有线或无线通信协议或任何合适的频率(例如ISM频带)与第一元件21进行通信。控制单元300可以以各种频率范围来传输输出脉冲信号。尽管在图示的实施方式中,仅示出第一元件21进行发射和接收功能,但是在其他实施方式中,控制单元300例如可以包括单独的接收和发射元件。
根据不同的实施方式,控制单元300可以使用集成的和/或分离的硬件元件、软件元件或其组合来实现。集成的硬件元件的示例可以包括处理器、微处理器、微控制器、集成电路、专用集成电路(ASIC)、可编程逻辑器件(PLD)、数字信号处理器(DSP)、现场可编程门阵列(FPGA)、逻辑门、寄存器、半导体期间、芯片、微芯片、芯片组、微控制器、系统集成芯片(SoC)或者系统封装(SIP)。分离的硬件元件的示例可以包括电路、电路元件(例如逻辑门、场效应晶体管、双极晶体管、电阻器、电容器、感应器、继电器等)。在其他实施方式中,控制单元300实现为在一个或多个衬底上包含分离和集成的电路元件或部件的混合电路。在各个实施方式中,控制单元300可以向马达控制单元提供数字(例如开/关,高/低)输出和/或模拟输出。马达控制单元也可以使用与控制单元300类似的元件和/或部件来实现。马达控制单元可以用于响应于来自一个或多个无源和/或有源传感器元件的辐射的回波响应信号来控制马达65。
返回图1-6,在一种实施方式中,第一元件21可以是通过有线电连接23耦合到控制单元300的感应元件(例如第一线圈)。有线电连接23可以是导电胶包线。第二元件35也可以是嵌入、与滑块33形成一体或者以其他方式连接至滑块33的感应元件(例如第二线圈)。第二元件35无线耦合至第一元件21。第一元件21优选与导电轴8电绝缘。第二元件35优选与滑块33和位于钉仓34和/或钉通道22中的其他部件电绝缘。第二元件35接收由第一元件21发射的输出脉冲信号,并以回波信号的形式反射或者散射电磁能。通过改变第二元件35的材料、尺寸、形状以及相对于第一元件21的位置,控制单元300可以通过解码反射的回波信号来确定位于端部执行器12中的各个部件的位置、类型、存在性和/或状态。
图12的示意图400示出控制单元300结合第一和第二元件21、35的一种实施方式的操作。以下的描述也参考图11。第一元件21通过通道(例如电连接23)连接至控制单元300。电连接23可以是有线的或者无线的。如前所述,通过以一个或多个触发脉冲402的形式发射询问信号,第一元件21无线地触发或者辐射第二元件35。触发脉冲402可以是任何合适的预定频率f,其可以由振荡器326来确定。触发脉冲402可以具有预定的脉冲宽度PW,其可以由调制器318来确定,并且触发脉冲402可以以脉冲重复率T来发射,其可以由编码器316来确定。入射(例如撞击或辐射)在第二元件35上的发射的触发脉冲402由第二元件35以回波响应脉冲404的形式反射或者散射。回波响应脉冲404是入射在第二元件35上的触发脉冲402的电磁能反射,但是信号强度较弱。在发射触发脉冲402之后,第一元件21接收回波响应脉冲404并以合适的方式将回波响应脉冲402耦合至控制单元300。解调器310接收较弱的回波响应脉冲404并进行放大和解调。解码器312和处理器306处理接收的回波响应脉冲404以从其提取信息。处理器306(或其他逻辑器件)可以被编程以根据接收的回波响应脉冲404来确定与端部执行器1 2和其他部件相关的各种特性。
回波响应脉冲404的频率f、PW和T可以与触发脉冲402相同。在不同的实施方式中,回波响应脉冲404的频率f、PW和T可以与触发脉冲402不同。在一种实施方式中,例如,回波响应脉冲404的频率f可以是触发脉冲402频率的谐波频率。回波响应脉冲404中反射的电磁能的量依赖于第二元件35的材料、形状和尺寸。回波响应脉冲404中反射的电磁能的能还依赖于第一元件21和第二元件35之间的距离D。
形成第二元件35的材料可以确定反射能量的量。例如,金属物体将比相同尺寸和形状的木制或塑料制物体等反射更多的能量。一般来说,材料的导电性能越好,反射性越好。第二元件35的形状也可以决定能量如何被反射或散射。例如,如果第二元件35具有面向第一元件21的平坦侧,则第二元件35可以向第一元件21反射回更多的能量。圆形物体可以在与由入射的电磁能撞击的表面垂直的各个方向上反射或者散射能量,不规则形状的物体将更加任意地散射入射的电磁能。第二元件21的尺寸也可以确定所反射能量的量。例如,较大的第二元件35将比相同材料和形状并与第一元件21之间的距离D相同的较小第二元件35反射更多的能量。应当理解,第二元件35相对于触发脉冲402的辐射电磁能的波长(λ)应当具有一定的最小尺寸,以产生实际反射的回波响应脉冲404。例如,第二元件35的尺寸可以等于或者大于触发脉冲402的电磁能的四分之一波长(λ/4)。发射的触发脉冲402的波长λ根据等式λ=c/f而与频率f相关,其中c是光速,f是信号频率。因此,为了检测减小的物体,波长λ必须较小并且由此频率f必须较高。可以选择任何合适的预定频率f来适应待检测的第二元件35的尺寸。由此,一旦确定了触发脉冲402的频率,可以将第二元件35的尺寸选择为例如大于或者等于λ/4(或者c/4f)。如前所述,由第二元件35反射的能量的量还依赖于第一元件21与第二元件35之间的距离。
由此,可以选择第二元件35的材料、形状和尺寸以及其与第一元件21之间的相对距离D,以产生唯一的回波响应脉冲404,该脉冲可以表示与第二元件35相关的所需测量结果。例如,唯一的回波响应脉冲404可以表示布置在外科器械10上的各个部件和/或子部件的位置、类型、存在性和/或状态。特别地,可以确定在关节运动枢轴14之后布置在外科器械10的端部执行器12部分中的各个部件和子部件。回波响应脉冲404还可以用于确定第一元件21和第二元件35之间的距离D。以此方式,通过将第二元件35集成或安装到使用部件,例如滑块33,可以通过控制单元300来处理回波响应脉冲35,以提取并提供与使用部件相关的信息,例如滑块33、钉仓34等的位置、类型、存在性和/或状态。这种布置可以消除对通过有线连接向第二元件35发射或提供功率的需要,并可以作为一种节约成本的方案以在外科器械10上设置不同的传感器元件。
在一种实施方式中,在第二元件35是有源传感器元件的情况下,如前所述,通过以一个或多个触发脉冲402的形式来发射询问信号,第一元件21无线地触发或辐射第二元件35。触发脉冲402的电磁能被传感器元件35接收并用于为传感器元件35加电。一旦被加电,传感器元件35将回波响应脉冲404发射回控制单元300。
在一种实施方式中,可以通过发射触发脉冲402并接收回波响应脉冲404来确定钉仓34的状态和滑块33的位置。如前所述,第一和第二元件21、35可以是无源传感器或电磁元件(其可以包括阻抗元件、感应元件或电容元件或其组合)。在一种实施方式中,第一元件21可以是位于轴8远端的主线圈形式的感应器(如图1、2和4-6所示)。第二元件35可以是位于滑块33中的副线圈形式的感应元件(如图3、5和6所示)。第一元件21“发出”或者发射触发脉冲402。由第二元件35反射的回波响应脉冲404可以表示滑块33存在于钉通道22中,可以表示从第一元件21到其的距离或者其沿着钉通道22的纵向位置。以此方式,器械10能够确定端部执行器12中是否存在钉仓34或滑块33或者钉仓34或滑块33的状态,或者能够确定滑块33沿着钉通道22的纵向位置。该信息例如可以用于确定钉仓34的加载状态。此外,第二元件35可以由不同材料形成,具有不同的形状和尺寸,以产生表示端部执行器11中的钉仓34的类型或存在性的唯一回波响应脉冲404。这消除了需要在端部执行器12中包含任何需要功率驱动的存储器或传感器元件,以通过电子的方式来确定端部执行器12中的钉仓34的类型、存在性或状态。
在另一种实施方式中,第二元件35可以连接到滑块33,回波响应脉冲404可以用于确定滑块33位于钉通道22近端处的第一位置还是位于钉通道33远端处的第二位置,或者它们之间的任何中间位置。控制单元300可以基于发射触发脉冲402和接收回波响应脉冲404之间经过的时间来确定滑块33的位置。滑块33在第一位置的情况下比在滑块33位于第二位置或任何中间位置的情况下都更快地接收回波响应脉冲404。例如,随着滑块33沿着钉通道22纵向移动,相对于发射的触发脉冲402,接收的回波响应脉冲404的响应时间增加。该信息可以被控制单元300用于确定滑块33在通道22中的中间位置,并为控制切割/紧固操作提供一些措施,例如在滑块33或其他部件不在预定位置时抑制切割/紧固操作。
在又一种实施方式中,控制单元300可以基于回波响应脉冲404在预定时间段内是否被接收来为切割/紧固操作的控制提供一些措施。例如,如果在预定时间段内接收到回波响应脉冲404,则控制单元300判定滑块33位于钉通道22上的近端。相反,如果在预定的时间段内没有接收到回波响应脉冲404,则控制单元300判定滑块33已经从钉通道22的近端向远端移动(例如器械已经被击发)。以此方式,如果没有接收到回波响应脉冲404,则控制单元300可以判定钉仓34已经被击发并且因此滑块33已经沿纵向远离钉通道22的近端移动,或者判定没有装载钉仓34并且因此防止器械10(例如外科缝合器)击发。
尽管示出第一元件21布置在细长轴8的靠近关节运动枢轴14的一端处,但是第一元件21可以布置在沿着细长轴8和/或手柄6的任何位置,并与第二元件35进行合适的无线或有线通信。
图13示出外科器械10的一种实施方式,其包括位于轴8的自由旋转接头29部分中的第一元件21。以下的描述也参考图3、5、6和12。第一元件21经由电连接23耦合至控制单元300。当外科器械10具有大量复杂的机械机头并且其很难保持直接的有线连接时,例如可以使用附加的元件。在这种情况下,感应耦合可以用穿越各个这样的接头。例如,感应耦合器可以用在旋转接头29的两侧上以及关节运动枢轴14的两侧上,其中位于旋转接头29远侧上的感应元件通过电连接连接至关节运动枢轴14近侧上的另一个感应元件。由此,第三元件328和第四元件330可以布置在轴8上。这些元件328、330可以沿着轴8布置在任何位置。第三元件328可以在关节运动控制器16之前布置在轴8的近端。第四元件330可以在关节运动枢轴14之间布置在轴8的远端。第三和第四元件328、330可以通过电连接332进行耦合,电连接332可以是有线或无线电连接。第二元件35布置或连接到端部执行器12中的使用部件。第三元件328无线连接到第一元件21,并从其接收触发脉冲402。第三元件328沿着电连接332向第四元件330发射触发脉冲402。第四元件330将触发脉冲402无线耦合至第二元件35。回波响应脉冲404以相反的顺序被传输回到第一元件21。例如,回波响应脉冲404被无线耦合到第四元件330,经由电连接332被中继到第三元件328,然后无线耦合到第一元件21。类似于第一和第二元件21、35,第三和第四元件328、330可以由有源和/或无源传感器元件(例如阻抗元件、电感元件、电容元件和/或半导体元件)形成。在一种实施方式中,第三和第四元件328、330可以是由各种材料形成的各种尺寸和形状的无源线圈,或者可以包含诸如晶体管之类的半导体元件,从而以有源模式进行操作。
图14图示了外科器械10的一种实施方式,其包括布置在轴上的各个位置处的传感器元件。例如,第一元件21可以在关节运动控制器16之前布置在轴8的近端。第一元件21经由无线电连接23无线耦合至控制单元300。第三元件328和第四元件330在关节运动控制器16之后并在关节运动枢轴14之前沿着轴8设置。第三元件328可以在关节运动控制器16之后布置在轴8的近端,第四元件330可以在关节运动枢轴14之前布置在细长轴8的远端。第三和第四元件328、330通过电连接332进行耦合,电连接332可以是有线或无线电连接。如前所述,第二元件35可以布置在位于端部执行器12中的使用部件上。第三元件328无线连接至第一元件21并从其接收触发脉冲402。第三元件328沿着电连接332向第四元件330发射触发脉冲402。第四元件330将触发脉冲402无线耦合至第二元件35。回波响应脉冲404以相反的顺序被传输回到第一元件21。例如,回波响应脉冲404被无线耦合到第四元件330,经由电连接332被中继到第三元件328,然后无线耦合到第一元件21。
图15示出了器械10的一种实施方式,其中轴用作用于控制单元300的部分天线。由此,通过向第二元件35辐射触发脉冲402并接收从第二元件35反射的回波响应脉冲404,器械10的轴8(例如包括近侧闭合管40和远侧闭合管42)可以一起用作用于控制单元300的部分天线。以此方式,可以经由器械10的轴8向控制单元300和布置在端部执行器12中的第二元件35发送和接收信号。
近侧闭合管40可以通过外部下侧件和上侧件59-62在其近端处接地,外部下侧件和上侧件59-62可以由诸如塑料之类的电绝缘材料制成。近侧和远侧闭合管40、42内的驱动轴组件部件(包括主驱动轴48和副驱动轴50)也可以由诸如塑料之类的电绝缘材料制成。此外,端部执行器12的部件(例如钉砧24和通道22)可以电连接(或者直接或间接地电接触)至远侧闭合管42,使得它们也可以用作部分天线。此外,第二元件35可以定位成使得其与作为天线的轴8和端部执行器12的部件电绝缘。例如,第二元件35可以定位在仓34中,仓34可以由诸如塑料之类的电绝缘材料制成。因为轴8的远端(例如远侧闭合管42的远端)和端部执行器12的作为天线的部分可以在距离上相对靠近第二元件35,所以用于发射信号的功率可以保持在较低的水平,由此使得与器械10的使用环境中的其他系统之间的干扰最小化。
在这样的实施方式中,控制单元300可以通过导电连接件400(例如导线)电耦合到器械10的轴8,例如耦合到近侧闭合管40。通过向第二元件35辐射触发脉冲402形式的信号并从第二元件35接收回波响应脉冲404形式的被辐射信号,轴8之外的部分(例如闭合管40、42)因此可以作为用于控制单元300的部分天线。由控制单元300接收的回波响应信号404可以通过解调器310来解调并通过解码器312来解码,如前所述。回波响应脉冲404可以包括来自第二元件35的信息,例如布置在器械10的端部执行器12部分上的各个部件的位置、类型、存在性和/或状态,处理器306可以用其来控制器械10的各个方面,例如马达65或者显示器。
为了将数据信号传输到端部执行器12中的第二元件35或者向其进行传输,电连接件410可以将控制单元300连接到器械10的轴8的部件,例如近侧闭合管40,其可以电连接到远侧闭合管42。远侧闭合管42优选与远处的传感器368电绝缘,该传感器368可以定位在塑料仓34中。如前所述,端部执行器12的部件(例如通道22和钉砧24)可以导电并与远侧闭合管42电接触,使得它们也可以作为天线的一部分。
在轴8作为用于控制单元300的天线的情况下,控制单元300可以与端部执行器2中的第二元件35通信,而不需要直接的有线连接。此外,因为轴8和第二元件35之间的距离是固定且已知的,所以能够将功率水平优化到较低水平,由此使得与器械10的使用环境中的其他系统之间的干扰最小化。
尽管通过该描述,示出第二元件35布置在关节运动端部执行器12中,但是第二元件35可以布置在器械10中任何合适的位置,同时在发射或接收周期的至少一部分上保持与第一元件(和/或轴8)无线通信。第二元件35还可以耦合到钉仓34中的任何部件。
控制单元300可以与第一元件21、第二元件35、第三元件328和第四元件330以及附加的元件中的任意元件通过复杂的机械接头(例如旋转接头29)来通信,而不需要直接的有线连接,而是通过无线连接,因为这里很难保持有线连接。此外,因为第一、第二、第三和第四元件21、35、328、330以及任何附加的元件和/或其任意组合之间的距离可以是固定且公知的,所以这些元件之间的耦合可以被最优化,用于有效地感应传输电磁能。此外,这些距离可以相对较短,使得可以使用相对较低功率的信号,并使得与器械10的使用中的其他系统之间的干扰最小化。
在其他实施方式中,更多或者更少的传感器元件可以被感应、电磁和/或以其他方式耦合。例如,在一些实施方式中,控制单元300可以包括与其一体形成的第一元件21。手柄6中的第一元件21和端部执行器12中的第二元件35可以直接通信而不需要第三和第四元件328、330。当然,在这样的实施方式中,由于手柄6中的控制单元300和端部执行器12中的第二元件35之间的距离较大,所以可能需要较强的信号。
在上述的实施方式中,电池64(图7)为器械10的击发操作供电(至少部分)。由此,器械10可以是所谓的“动力辅助”设备。动力辅助设备的更多细节和附加实施方式描述在’573申请中,通过引用将其包含这里。但是,应当认识到,器械10不必是动力辅助设备,而其仅仅是可以利用本发明各方面的一种类型设备的示例。例如,器械10可以包括由电池64驱动并由控制单元300控制的显示器(例如LCD或LED显示器)。来自端部执行器12中的传感器转发器3 68的数据可以显示在这样的显示器上。
已经结合切割式外科器械描述了本发明的不同实施方式。但是,应当注意,在其他实施方式,这里公开的发明的外科器械不必是切割式外科器械,而是可以用在包括远程传感器转发器的任何类型外科器械中。例如,其可以是非切割的内窥镜器械、抓钳、缝合器、夹具施放器、进入装置、药物/基因治疗输送装置、以及使用超声波、RF、或激光等的能量装置。此外,本发明例如可以是腹腔镜器械。本发明还可以应用于传统的内窥镜器械和开放式外科器械以及机械手辅助的外科手术。
这里公开的设备也可以被设计成在单次使用后被处置,或者它们可以被设计成多次使用。然而,在任一情况中,在至少一次使用之后设备可以被整修以供再使用。整修可以包括以下步骤的任何组合:拆卸设备,然后清洁或替换特殊零件,随后再组装。特别地,设备可以被拆卸,并且设备的许多特殊零件或部分可以在任何组合中选择性地被替换或去除。一旦清洁和/或替换特殊部分,在外科操作将要开始之前设备可以在整修设备或者由手术团队再组装供随后使用。本领域的技术人员将会理解设备的整修可以利用拆卸、清洁和/或替换,和再组装的多种技术。这种技术的使用以及形成的整修的装置都在本申请的范围内。
优选地,这里描述的本发明将在手术前被处理。首先,获得新的或用过的器械,必要时清洁器械。然后可以消毒器械。在一种消毒技术中,将器械放置在闭合和密封的容器中,例如塑料或TYVEK袋。然后将容器和器械放置在可以穿透容器的辐射场中,例如伽马辐射、x射线或高能电子。辐射杀死器械上和容器中的细菌。然后可以将已消毒器械储存在无菌容器中。密封容器保持器械无菌直到它在医疗机构中被打开。
优选该设备被消毒。对于本领域技术人员来说,这可以通过多种方式来实现,包括伽马辐射、环氧乙烷或蒸汽。
尽管本发明已经对一些公开的实施方式进行了描述,但可以对这些实施方式进行许多改进和变型。例如,可以使用不同类型的端部执行器。此外,对于公开的用于一些部件的材料,可以采用其他的材料。前述说明和后附的权利要求书旨在覆盖所有这些改进和变型。
这里,使用了表达“耦合”和“连接”以及它们的变形来描述一些实施方式。这些术语并不意图作为同义词。例如,使用数据“连接”和/或“耦合”来描述一些实施方式以表示两个或多个元件彼此直接物理或电接触。但是,术语“耦合”也可以指两个或多个元件不是彼此直接连接,而是协作或者彼此相互作用。
通过引用而全部或者部分并入本文中的任何专利、公开出版物或者其它公开的材料,仅限于不会与在本申请中公开的定义、陈述或者其它公开的材料相矛盾的部分。如此一来,必要时这里明显阐述的公开内容替代任何通过引用而并入本文中的相矛盾的材料。被声称通过引用并入本文中但是与本发明公开的定义、陈述或者其它公开的材料矛盾的任何材料或其部分将只并入不会使得所并入的材料与本发明公开的材料相矛盾的部分。
Claims (10)
1.一种外科器械,包括:
具有近端和远端的轴,所述轴包含第一传感器元件;
连接到所述轴的远端上的端部执行器,所述端部执行器包括第二传感器元件;和
连接到所述轴的近端上的手柄,所述手柄包括控制单元,其中,所述控制单元与所述第一传感器元件通信,并且所述第一传感器元件与所述第二传感器元件无线通信。
2.如权利要求1所述的外科器械,其中,所述手柄还包括:
与所述控制单元通信的马达,其中,所述马达用于驱动所述轴中主驱动轴组件,所述主驱动轴组件用于驱动所述端部执行器;和
用于为马达供电的电池。
3.如权利要求2所述的外科器械,其中,所述手柄还包括:
闭合扳机,用于在通过操作者回缩时使所述端部执行器夹紧定位在所述端部执行器中的物体;和
击发扳机,其与所述闭合扳机分离,用于在通过操作者回缩时使所述马达启动。
4.如权利要求1所述的外科器械,其中,所述控制单元包括:
发射器;
接收器;和
与所述发射器、所述接收器和第一传感器元件耦合的开关;
其中,所述开关将第一传感器元件耦合到所述发射器,以向所述第二传感器元件发射询问信号;并且
所述开关将第一传感器元件耦合到所述接收器,以响应于所述询问信号来接收由所述第二传感器元件反射的回波响应信号。
5.如权利要求4所述的外科器械,其中,所述控制单元包括:
与所述接收器连接的处理器,所述处理器用于基于所述回波响应信号来确定所述端部执行器的状态。
6.如权利要求1所述的外科器械,其中,所述控制单元与所述第一传感器元件无线通信。
7.如权利要求1所述的外科器械,其中,所述外科器械包括用于使轴旋转的至少一个旋转接头,其中,所述外科器械还包括:
在所述旋转接头的近侧位于所述轴中的第三传感器元件,其与所述第一传感器元件无线通信;和
与所述第三传感器元件通信的第四传感器元件,所述第四传感器元件在所述旋转接头的远侧位于所述轴中,并与所述第二传感器元件无线通信。
8.如权利要求7所述的外科器械,其中,所述至少一个旋转接头位于所述第三传感器元件和所述第四传感器元件之间。
9.如权利要求1所述的外科器械,其中,所述轴包括位于所述第一传感器元件和第二传感器元件之间的关节运动枢轴。
10.如权利要求1所述的外科器械,其中,所述外科器械包括内窥镜外科器械。
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Also Published As
Publication number | Publication date |
---|---|
CN101234033B (zh) | 2012-06-13 |
JP5220424B2 (ja) | 2013-06-26 |
ATE547052T1 (de) | 2012-03-15 |
HK1118432A1 (en) | 2009-02-13 |
US7954682B2 (en) | 2011-06-07 |
PL2356949T3 (pl) | 2016-09-30 |
JP2008206967A (ja) | 2008-09-11 |
EP2356949A2 (en) | 2011-08-17 |
EP1943958B1 (en) | 2012-02-29 |
EP1943958A1 (en) | 2008-07-16 |
EP2356949A3 (en) | 2012-05-30 |
US20080167671A1 (en) | 2008-07-10 |
EP2356949B1 (en) | 2016-03-16 |
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