CN103037781B - 具有用于调节端部执行器内的组织间隙的机构的马达驱动外科紧固件装置 - Google Patents

具有用于调节端部执行器内的组织间隙的机构的马达驱动外科紧固件装置 Download PDF

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CN103037781B
CN103037781B CN201180037051.6A CN201180037051A CN103037781B CN 103037781 B CN103037781 B CN 103037781B CN 201180037051 A CN201180037051 A CN 201180037051A CN 103037781 B CN103037781 B CN 103037781B
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end effector
motor
surgical fastener
anvil
switch
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F·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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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
    • 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
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681Aspects not otherwise provided for
    • A61B2017/00734Aspects not otherwise provided for battery operated
    • 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
    • A61B2017/07214Stapler heads
    • A61B2017/0725Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B17/2909Handles
    • A61B2017/2912Handles transmission of forces to actuating rod or piston
    • A61B2017/2923Toothed members, e.g. rack and pinion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B2017/320052Guides for cutting instruments

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Abstract

本发明公开了一种外科紧固件设备,所述外科紧固件设备具有柄部;细长轴,所述细长轴具有附接到柄部的近端和从细长轴延伸的远端;端部执行器,所述端部执行器包括在其近端处枢转并可在打开位置和闭合位置之间运动的一对钳口;包含多个外科紧固件的仓,所述仓附接到端部执行器;用于部署外科紧固件的电动致动器,所述致动器包括电源和马达;用于当端部执行器处于所述闭合位置时电动调节钳口之间的间距的量的装置。

Description

具有用于调节端部执行器内的组织间隙的机构的马达驱动外科紧固件装置
相关专利申请的交叉引用
本非临时申请是2010年1月26日提交的授予FrederickE.Shelton,IV的名称为“DrivenSurgicalStaplerImprovements”的美国专利申请序列号12/693,461的部分继续申请,该申请要求2009年2月6日提交的授予FrederickE.Shelton,IV的名称为“Motor-DrivenSurgicalStaplerImprovements”的美国临时申请序列号61/150,387的优先权,每份申请的全部公开内容以引用的方式全文并入本文中。
背景技术
适于内窥镜式应用的外科缝合器的实例在美国专利No.5,465,895中有所描述,该专利全文以引用方式并入本文中。此类装置包括具有不同的闭合和击发动作的内切割器。马达驱动外科缝合器的另一个实例在公布于2007年8月2日的名称为“Motor-DrivenSurgicalCuttingandFasteningInstrumentWithUserFeedbackSystem”的美国专利申请公开No.US2007/0175958A1中有所公开,该申请全文以引用方式并入本文中。此类公开的摘录在本文中提出以详述其基本功能、改进、背景和部件。最后公开了该系统的其它改进。
美国专利申请公开No.US2007/0175958A1部分地提出“[a]使用该装置的临床医生能够将钳口构件闭合在组织上以在击发之前定位组织。一旦临床医生确定钳口构件正确地夹住了组织,临床医生即可用单击发冲程或多击发冲程(取决于装置)来击发外科缝合器。击发外科缝合器使得组织被切断并缝合。同时进行切断和缝合避免了当利用分别仅进行切断和缝合的不同外科工具依次执行这些动作时可能产生的并发症。”
在击发前能够在组织上闭合的一个具体优点是,临床医生可经由内窥镜检查是否达到理想的切割位置,包括是否已在相对的钳口之间捕获足量的组织。否则,相对的钳口可能被拉得太近,特别是在它们的远端夹拢,并且因此不能在切断组织内有效形成闭合缝钉。另一个极端情况是,被夹持的过量组织可能使得束缚和不完全击发。
每一代内镜缝合器/切割器都在复杂性和功能方面不断增强。这种情形的主要原因中的一个在于追求将击发力(FTF)降低到所有外科医生或大多数外科医生均可操控的程度。降低FTF的一个已知解决方案是使用C02马达或电动马达。这些装置的击发并不比传统的手动装置好很多,而是有其不同的理由。外科医生通常更愿意体验与在使缝钉成形时由端部执行器所受的力成比例的力分布,以确保在大多数外科医生能力的上限(通常为约15-30lbs)内完成切割/缝合循环。如果外科医生在装置柄部中感受到的力过大或由于一些其它临床原因,他们通常还希望保持对缝钉部署的控制并能够随时停止。这些对于使用者的反馈作用,未能在现有马达驱动内切割器中适当实现。因此,对于切割/缝合操作仅仅通过按一下按钮来致动的马达驱动内切割器,医生还未普遍接受。
上述讨论仅仅为了举例说明技术领域内目前存在的一些不足,而不应看作是对权利要求范围的否定。
发明内容
根据本发明的一个总体方面,提供了一种具有柄部和细长轴的外科紧固件设备。细长轴具有附接到柄部的近端。细长轴还具有联接到包括一对钳口的端部执行器的远端,钳口在其近端处枢转并且可在打开位置和闭合位置之间运动。包含多个外科紧固件的仓附接到端部执行器。该设备还包括用于部署外科紧固件的电动致动器。在各个实施例中,致动器包括电源和马达。该设备还包括用于在端部执行器处于闭合位置时电动调节钳口之间的间距的量的装置。
根据本发明的另一个总体方面,提供了一种具有柄部的外科紧固件设备,柄部具有可操作地联接到其上的端部执行器。在各个实施例中,端部执行器包括能够支撑其中的仓的细长通道。砧被可运动地支撑在细长通道上,以选择性地朝细长通道运动到闭合位置以及远离所述细长通道运动到打开位置。在砧中具有细长槽。致动器构件被可运动地支撑在细长通道内,并可在细长通道内从未致动的近侧位置选择性地运动到致动位置。在各个实施例中,致动器构件包括可滑动地接合细长通道的下致动器部分以及能够突出到细长槽中的上致动器部分。保持器构件从上致动器部分的每个侧边沿基本上横向于砧中细长槽的方向突出。在每个保持器构件上提供高度调节构件,以在砧响应于施加到其上的电流处于闭合位置中的一个时选择性地调节砧与细长通道之间的间距。
根据本发明的另一个总体方面,提供了一种具有柄部的外科紧固件设备,柄部具有可操作地联接到其上的端部执行器。在各个实施例中,端部执行器包括能够支撑其中的仓的细长通道。砧被可运动地支撑在细长通道上,以选择性地朝细长通道运动到闭合位置以及远离所述细长通道运动到打开位置。在砧中具有细长槽。致动器构件被可运动地支撑在细长通道内,并可响应于通过支撑在柄部中的第一电动马达施加到其上的驱动运动在细长通道内从未致动的近侧位置选择性地运动到致动位置。在各个实施例中,致动器构件包括可滑动地接合细长通道的下致动器部分以及能够突出到细长槽中并相对于下致动器部分运动的上致动器部分。保持器构件从上致动器部分的每个侧边沿基本上横向于砧中细长槽的方向突出。第二电动马达联接到上致动器部分和下致动器部分,以使上致动器部分相对于下致动器部分选择性地运动。
在一个总体方面,本发明涉及电动外科切割和紧固器械,所述器械向使用者提供关于端部执行器的位置、力和/或部署的反馈。在各个实施例中,该器械还允许操作者控制端部执行器,包括能够在需要时停止部署。该器械可在其柄部中包括两个触发器(闭合触发器和击发触发器),所述两个触发器具有分开的执行动作。当该器械的操作者回缩闭合触发器时,端部执行器可夹住定位在端部执行器中的组织。然后,当操作者回缩击发触发器时,马达可经由齿轮传动系向旋转的主传动轴组件提供动力,使得端部执行器内的切割器械切断被夹住的组织。
在各个实施例中,该器械可包括具有加载力反馈和控制的动力辅助系统,以减少操作者施加的所需击发力,从而完成切割操作。在此类实施例中,击发触发器可啮合到主传动轴组件的齿轮传动系中。通过那样的方式,操作者可体验关于施加到切割器械上的力的反馈。也就是说,击发触发器上的加载力可能与切割器械受到的加载力有关。同样在此类实施例中,由于击发触发器被啮合到齿轮传动系,操作者施加的力可加到作用于马达的力。
根据各个实施例,当击发触发器回缩适当的量(例如5度)时,可致动通/断开关,向马达发送信号以按指定的速率旋转,从而开始致动传动轴组件和端部执行器。根据其它实施例,可使用比例传感器。比例传感器可向马达发送信号以按指定的速率旋转,该速率与操作者施加到击发触发器的力成比例。通过那样的方式,击发触发器的旋转位置与切割器械在端部执行器中的位置(例如,完全部署或完全回缩)大致成比例。操作者还可在冲程的某一点停止回缩击发触发器以停止马达,从而停止切割运动。此外,可使用传感器分别检测端部执行器冲程的起点(例如,完全回缩位置)和冲程的终点(例如,完全部署位置)。因此,传感器可提供适应控制系统,用以在马达、齿轮传动系和端部执行器的闭环系统之外控制端部执行器的部署。
在其它实施例中,击发触发器可不被直接啮合到用于启动端部执行器的齿轮传动系中。在此类实施例中,可用第二马达对击发触发器加力,以模拟端部执行器中切割器械的部署。可根据由旋转编码器测定的主传动轴组件的旋转增量来控制第二马达。在此类实施例中,击发触发器的旋转位置可与端部执行器中的切割器械位置相关。此外,可使用通/断开关或比例开关来控制主马达(即为主传动轴提供动力的马达)。
在各个具体实施中,端部执行器可在端部执行器的基座使用螺旋传动螺杆来驱动切割器械(例如刀)。端部执行器还可包括用于缝合切断组织的仓。根据其它实施例,可使用其它方法紧固(或封闭)切断组织,包括射频能量和粘合剂。
所述器械还可包括机械闭合系统。机械闭合系统可包括细长通道,该通道具有夹紧构件例如砧座,该夹紧构件可枢转地连接到该通道,以夹紧位于端部执行器中的组织。使用者可通过回缩闭合触发器来启动端部执行器的夹紧动作,所述闭合触发器通过机械闭合系统实现端部执行器的夹紧动作。一旦夹紧构件锁定在合适的位置,操作者即可通过回缩独立的击发触发器来启动切割操作。这可使得切割器械沿通道纵向行进,以切割被端部执行器夹住的组织。
在各个具体实施中,所述器械可包括用于启动端部执行器的旋转的主传动轴组件。此外,主传动轴可包括关节接头,使得端部执行器可被关节连接。关节接头可包括例如锥齿轮组件、万向接头或能够将扭力传递到端部执行器的柔性扭转缆索。
本发明的其它方面涉及用于将闭合触发器锁定到柄部下部的手枪式握把部分的各种机构。此类实施例将柄部中位于触发器正上方和正后方的空间空出来,用于器械的其它部件,包括齿轮传动系和机械闭合系统的部件。
本文的公开内容示出了操作电池供电的齿轮驱动独立的内窥镜式缝合装置的具体实施方式。
附图说明
通过结合附图并参考本发明的实施例的以下说明,本发明的上述和其它特征及优点及其获取方法将变得更加明显,并可更好地理解发明本身,其中:
图1和图2是根据本发明的各个实施例的外科切割和紧固器械的透视图;
图3-5是根据本发明的各个实施例的器械的端部执行器和轴的分解视图;
图6是根据本发明的各个实施例的端部执行器的侧视图;
图7是根据本发明的各个实施例的器械的柄部的分解视图;
图8和图9是根据本发明的各个实施例的柄部的局部透视图;
图10是根据本发明的各个实施例的柄部的侧视图;
图10A-10B示出可根据本发明的各个实施例使用的比例传感器或开关;
图11是用于根据本发明的各个实施例的器械中的电流控制电路的示意图;
图12是根据本发明的各个实施例的另一个柄部的侧视图;
图13是用于根据本发明的各个实施例的器械中的另一个电流控制电路的示意图;
图14是用于根据本发明的各个实施例的器械中的另一个电流控制电路的示意图;
图15是用于根据本发明的各个实施例的器械中的另一个电路的示意图;
图15A是用于根据本发明的各个实施例的器械中的另一个电流控制电路的示意图;
图15B是用于根据本发明的各个实施例的器械中的另一个电流控制电路的示意图;
图16-17示出根据本发明的各个实施例的用于锁定闭合触发器的不同机构;
图18是用于根据本发明的各个实施例的器械中的另一个电流控制电路的示意图;
图19是本发明的端部执行器实施例的截面图;
图20是本发明的刀组件或致动器实施例的侧正视图;
图21是本发明的另一个刀组件或致动器实施例的侧正视图;
图22是本发明的另一个刀组件或致动器实施例的侧正视图;
图23是根据本发明的实施例的外科缝合器的远端的透视图;
图24是根据本发明的实施例的外科缝合器的远端的透视图,其中仓已从通道中移除;
图25是与图1类似的根据本发明的实施例的外科缝合器的远端的视图,图中示出了闭锁指示灯;以及
图26是根据本发明的实施例的外科缝合器的近端的透视图。
具体实施方式
本专利申请的所有者也拥有与本专利同一日期提交的以下美国专利申请,这些专利各自以引用方式相应地全部并入本文:
名称为“MotorDrivenSurgicalFastenerDeviceWithCuttingMemberReversingMechanism”的代理人案卷号为END6549USCIP1/100280CIP1的美国专利申请;以及
名称为“MotorDrivenSurgicalFastenerDeviceWithCuttingMemberLockoutArrangements”的代理人案卷号为END6547USCIP1/100270CIP1的美国专利申请。
现在将描述某些示例性实施例,以从整体上理解本文所公开的装置和方法的结构、功能、制造和用途。这些实施例的一个或多个实例在附图中示出。本领域的普通技术人员将会理解,本文特别描述和在附图中示出的器械和方法为非限制性的示例性实施例,并且本发明的各个实施例的范围仅由权利要求书限定。就一个示例性实施例进行图解说明或描述的特征,可与其它实施例的特征组合。这种修改形式和变化形式旨在包括在本发明的范围之内。
本说明书通篇引用的“各个实施例”、“一些实施例”、“一个实施例”或“实施例”、“具体实施”或“各个具体实施”等,是指结合所述实施例描述的具体特征、结构或特性包括在至少一个实施例中。因此,本说明书通篇出现的短语“在各个实施例中”、“在一些实施例中”、“在一个实施例中”或“在实施例中”、“具体实施”或“各个具体实施”等并不一定都指相同的实施例或具体实施。此外,在一个或多个实施例或具体实施中,可按照任何合适的方式组合具体特征、结构或特性。因此,在没有限制的情况下,结合一个实施例示出或描述的具体特征、结构或特性可全部或部分地与一个或多个其它实施例的特征、结构或特性结合。这种修改形式和变化形式旨在包括在本发明的范围之内。
本文所用术语“近侧”和“远侧”是相对于操纵外科器械柄部的临床医生而言的。术语“近侧”是指最靠近临床医生的部分,术语“远侧”则是指远离临床医生的部分。还应当理解,为简洁和清楚起见,本文可以结合附图使用例如“竖直”、“水平”、“上”和“下”之类的空间术语。然而,外科器械在许多方向和位置中使用,并且这些术语并非限制性和/或绝对的。
图1和图2示出了根据本发明的各个实施例的外科切割和紧固器械10。图示实施例是内窥镜式外科器械10,通常本申请描述的器械10的实施例是内窥镜式外科切割和紧固器械。但是,应该指出的是,根据本发明的其它实施例,器械10可为非内窥镜式外科切割器械,例如腹腔镜式器械。
图1和图2示出的外科器械10包括柄部6、轴8以及在关节运动枢轴14处可枢转地连接到轴8的关节运动端部执行器12。关节控制部16可被设置成邻近柄部6,以使端部执行器12围绕关节枢轴14旋转。应当理解,各个实施例可包括非枢转的端部执行器,因此可能不具有关节枢轴14或关节控制器16。此外,在图示的实施例中,端部执行器12可构造成用于夹紧、切断和缝合组织的内切割器,虽然在其它实施例中可采用不同类型的端部执行器,如用于其它类型的外科器械的端部执行器,例如抓握器、切割器、缝合器、施夹器、进入装置、药物/基因治疗装置,超声波、射频或激光装置等。
器械10的柄部6可包括用于启动端部执行器12的闭合触发器18和击发触发器20。应当理解,具有涉及不同外科任务的端部执行器的器械可具有用于操纵端部执行器12的不同数量或类型的触发器或其它合适的控制器。端部执行器12被显示为优选地通过细长轴8与柄部6分开。在一个实施例中,临床医生或器械10的操作者可利用关节控制器16使端部执行器12相对于轴8进行关节动作,如由GeoffreyC.Hueil等人在名称为“SurgicalInstrumentHavingAnArticulatingEndEffector”的美国专利No.7,670,334中更详细描述的,该专利全文以引用方式并入本文中。
在该实例中,此外,端部执行器12包括构造成可操作地支撑其中的仓34的细长通道22和可枢转平移的夹持构件,例如砧24,砧24被保持在确保有效地缝合和切断被夹持在端部执行器12中的组织的间距处。柄部6包括手枪式握把26,由临床医生将闭合触发器18枢转地拉向手枪式握把26,以使砧24朝端部执行器12的细长通道22夹持或闭合,从而夹持住置于砧24和细长通道22之间的组织。击发触发器20在闭合触发器18的更外侧。如以下进一步描述的,一旦闭合触发器18被锁定在闭合位置,击发触发器20即可朝手枪式握把26稍微旋转以使得其可由操作者单手触及到。然后,操作者可将击发触发器20朝手枪式握把26枢转地拉动以缝合和切断被夹持在端部执行器12中的组织。在其它实施例中,可使用除砧24之外的不同类型的夹持构件,例如,相对的钳口等。
闭合触发器18可被首先启动。一旦临床医生对于端部执行器12的定位感到满意,则临床医生可将闭合触发器18拉回至其邻近手枪式握把26的完全闭合、锁定的位置。然后,驱动击发触发器20。当临床医生移除压力时,击发触发器20返回到打开位置(如图1和图2所示),如下面将更全面描述。当按下柄部6上的释放按钮时,可释放被锁定的闭合触发器18。释放按钮可按各种方式来实现,例如图16示出的滑动释放按钮160和/或图17示出的按钮172。
图3-6示出根据各个实施例的旋转驱动端部执行器12和轴8的实施例。图3是根据各个实施例的端部执行器12的分解视图。如图示实施例所示,除了先前提到的槽22和砧24之外,端部执行器12还可包括切割器32、滑块33、可拆卸地安装在槽22中的仓34和螺杆轴36。例如,切割器械32可为刀。如本文所用,结合至少一个实施例,术语“致动器”可指刀和/或滑块。砧24可在枢轴销25处枢转地打开和闭合,枢轴销25连接到槽22的近端。砧24还可包括位于其近端处的凸块27,所述凸块27插入机械闭合系统(以下进一步描述)的部件中以打开和闭合砧24。当闭合触发器18被驱动即被器械10的使用者内扳时,砧24可围绕枢轴销25转入夹紧或闭合位置。如果端部执行器12的夹持令人满意,则操作者可驱动击发触发器20,如以下更详细说明的,使刀32和滑块33沿槽22纵向行进,从而切割夹持于端部执行器12中的组织。滑块33沿槽22的运动将仓34的缝钉(未示出)推入而穿过切开的组织并贴靠砧24,这使缝钉弯曲而将切开的组织紧固。在各个实施例中,滑块33可为仓34的一体部件。授予Shelton,IV等人的名称为“SurgicalStaplingInstrumentIncorporatinganE-beamFiringMechanism”的美国专利No.6,978,921提供了关于这样的双行程切割和紧固器械的更多细节,该专利以引用方式并入本文中。滑块33可为仓34的一部分,使得当刀32在切割操作后回缩时,滑块33不回缩。
图4和图5为根据各个实施例的端部执行器12和轴8的分解视图,而图6为其侧视图。正如图示实施例中所示,轴8可包括由枢轴连接件44枢转地连接的近侧闭合管40和远侧闭合管42。远侧闭合管42包括开口45,砧24上的凸块27插入开口45中以打开和闭合砧24,如下面进一步描述。近侧脊管46可设置在闭合管40、42内。经由锥齿轮组件52与次(或远侧)传动轴50连接的主旋转(或近侧)传动轴48可设置在近侧脊管46内。次传动轴50连接到与螺杆轴36的近侧传动齿轮56接合的传动齿轮54。竖式锥齿轮52b可位于近侧脊管46远端的开口57中且能够在其中枢转。远侧脊管58可用来包封次传动轴50和传动齿轮54、56。在本文中有时将主传动轴48、副传动轴50和关节活动组件(例如锥齿轮组件52a-c)整体称作“主传动轴组件”。
定位在钉槽22远端处的轴承38容纳传动螺杆轴36,从而允许传动螺杆轴36可相对于槽22自由旋转。螺杆轴36可交接刀32的带螺纹开口(未示出),使得轴36的旋转使得刀32朝远侧或近侧(根据旋转方向)平移穿过钉槽22。因此,当主传动轴48在将启动运动施加到击发触发器20后被迫旋转(在下面详细解释)时,锥齿轮组52a-c使次传动轴50旋转,这继而又由于传动齿轮54、56的啮合而使得螺杆轴36旋转,这使刀驱动构件32沿通道22纵向行进而切割被夹紧在端部执行器12内的任何组织。滑块33可由例如塑料制成,并且可具有倾斜的远侧表面。由于滑块33穿越槽22,因此其倾斜前表面可上推或驱动仓中的缝钉穿过被夹持的组织,并抵靠砧24。砧24使缝钉成形或弯曲,从而缝合切断的组织。当刀32回缩时,刀32与滑块33可脱离,从而使滑块33留在槽22的远端。
图7-10示出马达驱动内切割器(特别是其柄部)的示例性实施例,该实施例提供关于端部执行器12中的切割装置32的部署和加载力的使用者反馈。此外,该实施例可利用使用者在拉回击发触发器20时提供的动力来对器械供能(所谓的“助力”模式)。该实施例可与上述的旋转驱动端部执行器12和轴8的实施例一起使用。如图示实施例中所示,柄部6包括外部下侧件59、60和外部上侧件61、62,它们配合在一起在整体上形成柄部6的外部。在各个实施例中,旋转驱动端部执行器可由马达65和电源64提供动力,马达65设置在柄部的手枪式握把部分26的上部中。电源64可包括电池或交流电源。在一个优选的实施例中,电源64包括被支撑在柄部6的手枪式握把部分26中的锂离子电池。根据各个实施例,马达65可为DC有刷驱动马达,其最大转速大约为5000RPM。马达65可驱动包括第一锥齿轮68和第二锥齿轮70的90度锥齿轮组件66。锥齿轮组66可驱动行星式齿轮组72。行星式齿轮组件72可包括连接到传动轴76的小齿轮74。小齿轮74可驱动与之配合的环形齿轮78,该环形齿轮经传动轴82驱动螺旋形齿轮鼓80。环84可螺旋接合在螺旋齿轮鼓80上。因此,当马达65旋转时,环84利用介于其间的锥齿轮组件66、行星式齿轮组件72和环形齿轮78而沿螺旋形齿轮鼓80行进。
柄部6还可包括与击发触发器20连通的运行马达开关110(见图10),以在操作者已将击发触发器20朝柄部6的手枪式握把部分26拉近(或闭合)时接收来自击发触发器20的启动运动,从而启动由端部执行器12执行的切割/缝合操作。运行马达开关110可为比例传感器,例如变阻器或可变电阻器。当击发触发器20被拉近时,运行马达开关110允许电流从电源64流至马达65。当运行马达开关110为可变电阻器等时,马达65的转速可与击发触发器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闭合击发触发器20,则马达65的转速较低。当完全拉近击发触发器20(或者处于完全闭合位置)时,马达65的转速为其最大值。换句话讲,使用者越用力拉动击发触发器20,施加到马达65上的电压就越大,从而转速就越大。
柄部6可包括与击发触发器20上部相邻的中间柄部构件104。柄部6还可包括连接在中间柄部构件104上的柱和击发触发器20上的柱之间的偏置弹簧112。偏置弹簧112可将击发触发器20偏置到其完全打开位置。这样,当操作者释放击发触发器20时,偏置弹簧112将击发触发器20拉向其打开位置,由此禁用运行马达开关110以停止马达65的旋转。此外,借助于偏置弹簧112,每当使用者闭合击发触发器20时,使用者将感受到对闭合操作的阻力,从而向使用者提供有关马达65所施加的旋转量的反馈。此外,操作者可停止回缩击发触发器20,从而禁用运行马达开关110和停止马达65。这样,使用者即可停止端部执行器12的部署,从而为操作者提供了对切割/紧固操作进行控制的方式。
螺旋齿轮鼓80的远端包括驱动环形齿轮122的远侧传动轴120,所述环形齿轮122与小齿轮124啮合。小齿轮124连接到主传动轴组件的主传动轴48。这样,马达65的旋转致使主传动轴组件旋转,从而启动端部执行器12,如上所述。
螺纹接合在螺旋齿轮鼓80上的环84可包括设置在开槽臂90的槽88内的柱86。开槽臂90在其相对端94上具有开口92,开口92容纳连接在柄部外侧件59、60之间的枢轴销96。枢轴销96还穿过击发触发器20中的开口100和中间柄部构件104中的开口102而设置。
此外,在柄部6可包括换向马达开关(或行程结束开关)130和止动马达(或行程开始)开关142。在各个实施例中,换向马达开关130可为位于螺旋齿轮鼓80远端的限位开关,使得螺纹接合在螺旋齿轮鼓80上的环84在其到达螺旋齿轮鼓80的远端时接触并触动换向马达开关130。当启动时,换向马达开关130向马达65发送信号(即允许电流流动)以使其旋转方向换向,从而在切割操作之后将端部执行器12的刀32撤回。
马达停止开关142可为例如常闭限位开关。在各个实施例中,其可位于螺旋齿轮鼓80的近端处,使得环84到达螺旋齿轮鼓80的近端时触动开关142。
在操作中,当器械10的操作者向击发触发器20施加启动运动时,运行马达开关110检测击发触发器20的部署并发送信号(即,允许电流流动)至马达65,以使得马达65例如以与操作者向后拉动击发触发器20的力大小成正比的速率正向旋转。马达65的正向旋转继而使得行星式齿轮组件72的远端处的环形齿轮78旋转,从而使得螺旋形齿轮筒80旋转,使通过螺纹连接在螺旋形齿轮鼓80上的环84沿螺旋形齿轮鼓80朝远侧行进。螺旋齿轮鼓80的旋转还驱动如上所述的主传动轴组件,这继而使端部执行器12中的刀32被部署。也就是说,使得刀32和滑块33朝远侧遍历通道22,从而切割夹持在端部执行器12中的组织。此外,在使用缝合型端部执行器12的实施例中使端部执行器12进行缝合操作。
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将已到达螺旋齿轮鼓80的远端,从而使得换向马达开关130被启动,开关130将发送信号(即,允许电流流动)至马达65以使马达65的旋转反向。这继而使得刀32回缩,并且还使螺旋齿轮鼓80上的环84移回到螺旋齿轮鼓80的近端。
中间柄部构件104包括与开槽臂90接合的后侧肩106,如图8和图9中清晰显示。中间柄部构件104还具有与击发触发器20接合的前移阻挡件107。如以上所解释,开槽臂90的运动受马达65旋转的控制。当开槽臂90随着环84从螺旋齿轮鼓80的近端行进到远端而逆时针旋转时,中间柄部构件104将不受约束而逆时针旋转。因此,当使用者拉近击发触发器20时,击发触发器20将与中间柄部构件104的前移阻挡件107接合,使中间柄部构件104逆时针旋转。然而,由于后侧肩106与开槽臂90接合,中间柄部构件104将只能够在开槽臂90许可的范围内逆时针旋转。这样一来,如果马达65出于某种原因停止旋转,则开槽臂90就会停止转动,使用者会无法进一步拉近击发触发器20,由于中间柄部构件104由于开槽臂90的约束而不能自由逆时针转动。
图10A和图10B示出了根据本发明的各个实施例的可用作运行马达开关110的可变开关或传感器的两种状态。运行马达开关110可包括表面部分280、第一电极(A)282、第二电极(B)284以及电极282、284之间的可压缩电介质材料286,例如电活性聚合物(EAP)。运行马达开关110可设置成在回缩时使表面部分280接触击发触发器20。因此,当击发触发器20缩回时,电介质材料286被压缩,如图10B所示,使电极282、284一起靠得更近。由于电极282、284之间的距离“b”直接关系到电极282、284之间的阻抗,距离越大阻抗就越大,距离越小阻抗就越小。这样,由于击发触发器20的拉回而使电介质286被压缩的量(图10B中以力“F”表示)与电极282、284之间的阻抗成比例,这可用于按比例控制马达65。
通过将闭合触发器18拉回来闭合(或夹持)端部执行器12的砧24的示例性闭合系统的元件还示出于图7至图10中。在图示实施例中,该闭合系统包括一个通过枢轴销251连接到闭合触发器18的轭形件250,所述枢轴销251被插入对准的位于闭合触发器18和轭形件250这二者上的开口。闭合触发器18绕枢轴销252枢转,并且枢轴销252插入穿过闭合触发器18中的另一开口,该开口偏离销251插入穿过闭合触发器18的位置。因此,闭合触发器18的回缩使得闭合触发器18的上部逆时针旋转,轭形件250经由销251附接到闭合触发器18。轭形件250的远端通过销254连接到第一闭合托架256。第一闭合托架256连接到第二闭合托架258。闭合托架256、258共同限定开口,近侧闭合管40(见图4)的近端安放并保持在该开口中,使得闭合托架256、258的纵向运动引起近侧闭合管40的纵向运动。器械10还包括设置在近侧闭合管40内部的闭合杆260。闭合杆260可包括窗口261,位于柄部外部件中的一个(例如图示实施例中的外部下侧件59)上的支柱263设置在窗口261中,以将闭合杆260固定连接到柄部6。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,其装配在近侧脊管46中的腔269内并由帽271(见图4)保持在腔内。
在操作中,当轭形件250由于闭合触发器18的回缩而旋转时,闭合托架256、258使得近侧闭合管40朝远侧运动(即远离器械10的柄部端),这使得远侧闭合管42朝远侧运动,从而使得砧24绕枢轴销25旋转到夹紧或闭合位置。当闭合触发器18被从锁定位置释放时,近侧闭合管40因此向近侧滑动,从而使得远侧闭合管42向近侧滑动,通过插入远侧闭合管的窗口中45的凸块27,这使得砧24绕枢轴销25枢转至打开或解锁位置。这样,通过回缩并锁定闭合触发器18,操作者可将组织夹持在砧24和槽22之间,并能够在切割/缝合操作后通过将闭合触发器20从锁定位置释放来解锁该组织。
图11是根据本发明的各个实施例的器械10中的电流控制电路的示意图。当操作者初始在锁定闭合触发器18之后拉击发触发器20时,运行马达开关110被启动,使得电流从其流过。如果常开马达换向传感器开关130打开(表明还未到达端部执行器行程的末尾),电流将流向单刀双掷继电器132。由于马达换向传感器开关130未闭合,则继电器132的电感器134不通电,因此继电器132将处于其未通电状态。该电路还包括仓闭锁开关136。如果端部执行器12包括仓34,则开关136将处于闭合状态,从而使电流流动。相反,如果端部执行器12不包括仓34,则开关136断开,从而防止电池64向马达65供电。
当仓34存在时,开关136闭合,为单刀单掷继电器138供电。当为继电器138供电时,电流流经继电器136,流过可变电阻器(运行马达)开关110,并经由双刀双掷继电器140到达马达65,从而为马达65供电并使其正向旋转。
当端部执行器12达到其行程末尾时,换向马达开关130被启动,从而闭合换向马达开关130并为继电器134供电。这使得继电器134呈现其通电状态,该状态使得电流绕过仓闭锁开关136和可变电阻器110而流向常闭双刀双掷继电器142,并经由继电器140流回到马达65,但其方式使得马达65反向旋转。
由于止动马达开关142是常闭的,因此电流将流回到继电器134以保持其闭合,直到止动马达开关142断开。当刀32完全回缩时,止动马达开关142被启动,使得止动马达开关142断开,从而将马达65断电。
在其它实施例中,代替比例式开关110,可使用通断式传感器或开关。在此类施例中,马达65的转速将不与操作者施加的力成比例。确切地讲,马达65一般以恒速旋转。但是由于击发触发器20与齿轮传动系接合,因此操作者仍将感受到力反馈。
如上文所指,在缝合器的功能中存在几个通常必须以确定的次序实现的步骤。例如,一旦闭合触发器被夹持,即可启动击发循环。在刀已完全部署之后,系统的回缩是下一个顺序步骤。系统除使用者控制外还包括电源(即,电池或气动装置),可减少需使用者开始的步骤(从而降低装置复杂性),系统自身即可开始完成这些步骤,如上文所讨论的。
然而,可能理想的是让使用者能够直观地延缓、减慢或停止这些本来“自动的”致动。例如,相同的致动按钮将允许在类似美国专利申请序列号11/344,035(现在的美国专利No.7,422,139,其公开内容全文以引用方式并入本文中)中公开的装置的触觉反馈装置中的击发启动,该致动按钮可由在回缩期间按下该按钮的使用者用来减慢或停止自动返回系统。
例如,图12和图13示出本发明的另一个实施例,其中回缩触发器121被支撑在击发触发器20上以用于与其一起行进。更具体而言,回缩触发器121被可枢转地支撑在击发触发器销96上且穿过击发触发器20中的槽(未示出)突出。弹簧125附接在击发触发器100的联接部分123和回缩触发器121的安装部分127之间以将回缩触发器121偏置到未致动位置。第二常闭回缩开关131安装在柄部内且取向成使得当击发触发器20在完全致动位置和完全未致动位置之间运动时,回缩触发器121的启动部分129不启动回缩开关131。然而,回缩触发器121的安装部分127和启动部分129能够使得可通过朝击发触发器20按下回缩触发器121而使启动部分129与回缩开关131启动接触,而不论击发触发器20在回缩过程期间位于何处。
如上文所讨论的,当端部执行器12到达其行程末尾时,行程开关130的结束将被启动。如图13的实例所示,回缩开关131与行程结束开关130串联。由于回缩开关131是常闭的,因此当开关130、131均闭合时,继电器134将通电。这使得继电器134呈现其通电状态,该状态使电流绕过仓闭锁传感器136和可变电阻器110。电流流向双刀双掷继电器140并经由继电器140流向马达65,但其方式使得马达65反向旋转。由于行程开始开关142是闭合的,因此电流将流回到继电器134以保持其闭合,直到开关142断开。当刀32完全回缩时,行程开始开关142断开,从而使马达65断电。然而,如果使用者希望减慢回缩过程,则使用者可按下回缩触发器121以启动回缩开关131的可变电阻部分133。当回缩触发器121未被按下时,可变电阻部分133的电阻为最小。当触发器121被按下时,可变电阻部分133的电阻与回缩触发器121的按压力成比例以减小到马达65的电路。进一步按下回缩触发器121将减慢回缩过程,直到回缩开关131的常闭触点部分135断开并阻止电流流向马达65。在各个实施例中,一旦使用者释放回缩触发器121,弹簧125将把回缩触发器121运动到未致动位置,并且开关131的触点部分135将返回至常闭位置且因此允许电流流回至马达65以完成回缩过程。
上述回缩开关和回缩触发器构造的独特和新颖特征也可结合美国专利申请公开No.US2010/007674A1和美国专利No.7,422,139中公开的各个实施例使用,这些专利均全文以引用方式并入本文中。例如,图14示出了本发明的电流控制电路实施例的另一个实施例。当(i)运行马达(或击发)开关110闭合(图14中显示为断开状态),(ii)安全开关240闭合(图14中显示为断开)以表明装置安全建立,并且(iii)常闭闭锁开关242断开以表明器械不处于闭锁状态时,电流流过安全开关240,流过闭锁指示灯244(其可为如图14所示的LED)并到达马达65。当到达切割行程的末尾时,行程结束或方向开关130被切换,逆转马达65的方向(击发开关110也已被释放)。在该状态下,电流也流过反向指示灯246,例如LED,从而提供马达方向已逆转的视觉指示。
如图14所示,电路还可包括手动返回开关248。当切割器械32仅被部分击发时,操作者可手动启动该开关。转换手动返回开关248可使马达65反向旋转,从而使切割器械32返回其初始或起始位置。如果使用者希望减慢或停止回缩过程,则使用者按下回缩触发器121以启动回缩开关131的可变电阻部分133。当触发器121被按下时,电阻与按压力成比例地增加以减少到马达65的电流。进一步按下回缩触发器121将减慢回缩过程,直到回缩开关131的常闭触点部分135断开并阻止电流流向马达65。在各个实施例中,一旦使用者释放回缩触发器121,弹簧125将把回缩触发器121运动到未致动位置,并且开关131的触点部分135将返回至常闭位置且因此允许电流流回至马达65以完成回缩过程。
电动外科器械的另外的配置在名称为“Motor-DrivenSurgicalCuttingInstrument”的已公布的美国专利申请公开No.US2010/0076474A1中有所公开,该申请全文以引用方式并入本文中。例如,图15是根据本发明的各个实施例的另一个电流控制电路的示意图。在各个实施例中,马达控制电路可包括一个或多个集成电路(IC),例如处理器、存储器、微控制器、时间电路等。在其它实施例中,马达控制电路可不包括任何IC。这样的非IC电流控制电路可能是有利的,由于要对包括IC的外科器械进行消毒往往是困难、复杂且昂贵的。
当操作者在锁定闭合触发器18后初始地向击发触发器20施加启动运动时,运行马达开关110被启动(或闭合),使得电流可从中流过。如果常开马达换向传感器开关130打开(表明还未到达端部执行器行程的末尾),电流将流向单刀双掷继电器132。当马达换向传感器开关130未闭合时,继电器132的线圈134将不通电,因此继电器132将处于其未通电状态。
如图15所示,电路也可包括并联连接的电阻元件144和开关146,其中并联的元件与继电器132串联连接。电阻元件144和开关146也连接到电源64。开关146可由响应于切割器械位置传感器150的控制电路148控制。根据各个实施例,当切割器械32(i)非常接近其行程起点且(ii)非常接近其行程末尾时,控制电路148可断开开关146。例如,当切割器械32(i)离其行程起点0.001英寸且(ii)离其行程末尾0.001英寸时,如切割器械位置传感器150所确定的,控制电路可断开开关。在开关146断开的情况下,电流流过电阻元件144,然后流过继电器132、继电器138、运行马达传感器开关110,到达马达65。流过电阻元件144的电流减小输送至马达65的电流大小,从而减小由马达65输送的功率。因此,当切割器械32(i)非常接近其行程起点或(ii)非常接近其行程末尾时,由马达65输送的功率减小。反之,一旦切割器械32运动得足够远离其行程点的起点或末尾,控制电路148即可闭合开关146,从而短接电阻元件144,从而增加到马达65的电流,进而增加由马达输送的功率。
根据各个实施例,电流控制电路还包括总体限定联锁电路137的闭锁传感器开关136a-d,当继电器132不通电时,来自继电器132的电流通过联锁电路137,以便启动马达65的电操作。每个闭锁传感器开关136a-d可构造成分别响应于对应条件的存在或不存在保持断开(即非导电)开关状态或闭合(即导电)开关状态。如在器械10被击发时存在,则对应条件中的任一个可使得不令人满意的切割和缝合操作和/或对器械10的损坏。闭锁传感器开关136a-d可响应于的条件包括例如:(a)通道22中不存在仓34;(b)通道22中存在用过的(例如以前击发的)仓34;以及(c)砧24相对于通道22的打开(换句话讲未充分闭合)位置。闭锁传感器开关136a-d可响应于的其它条件,例如部件磨损,可基于由器械10产生的击发操作的累计次数而推断。因此,在各个实施例中,如果存在这些条件中的任一种,则对应闭锁传感器开关136a-d保持断开开关状态,由此防止启动马达65的操作所需的电流的通过。在各个实施例中,仅在所有条件均被修复之后,才允许由闭锁传感器136a-d通过电流。应当理解,上述条件仅以举例方式提供,并且可提供附加的闭锁传感器开关,以用于响应于对器械10的操作有害的其它条件。类似地应当理解,对于其中上述条件中的一个或多个可能不存在或不重要的实施例来说,闭锁传感器开关的数量可能少于图示数量。
如图15所示,闭锁传感器开关136a可利用常开开关配置实现,使得当仓34处于对应于其被通道22的正确容纳的位置中时,保持闭合开关状态。当仓34未安装在通道22中或者未正确安装(例如未对齐)时,闭锁传感器开关136a保持断开开关状态。闭锁传感器开关136b可利用常开开关配置实现,使得仅当通道22中存在未用过的仓34(即,具有在未击发位置的滑块33的仓34)时,保持闭合开关状态。通道22中用过的仓34的存在使得闭锁传感器开关136b保持断开开关状态。闭锁传感器开关136c可利用常开开关配置实现,使得当砧24相对于通道22处于闭合位置时,保持闭合开关状态。闭锁传感器开关136c可根据延时特征来控制,其中仅在砧24在闭合位置持续预定时间段之后,才保持闭合开关状态。
闭锁传感器开关136d可利用常闭开关配置实现,使得仅当由器械10产生的击发的累计次数小于预定次数时,才保持闭合开关状态。闭锁传感器开关136d可与计数器139连通,计数器139构造成用于:保持代表由器械10进行的击发操作的累计次数的计数;比较该计数与预定次数;以及基于这种比较控制闭锁传感器开关136d的开关状态。虽然在图15中单独地示出,但应当理解,计数器139可与闭锁传感器开关136d一体化以便形成通用装置。优选地,计数器139实现为具有输入的电子装置,以用于基于提供给其的离散电信号的跃迁递增所保持的计数。应当理解,也可使用机械计数器,其构造用于基于机械输入(例如,击发触发器20的回缩)而保持计数。当实现为电子装置时,存在于电路中的每个击发操作跃迁一次的任何离散电信号都可用于计数器139输入。例如,如图15所示,可使用由行程结束传感器130的启动使得的离散电信号。计数器139可控制闭锁传感器开关136d的开关状态,使得当所保持的计数小于存储在计数器139内的预定次数时,保持闭合开关状态。当所保持的计数等于预定次数时,计数器139使得闭锁传感器开关136d保持断开开关状态,由此防止电流通过其中。应当理解,由计数器139存储的预定次数可根据需要选择性地调节。根据各个实施例,计数器304可与例如LCD显示器的外部显示器(未示出)连通,该显示器一体化到器械10中以用于向使用者指示所保持的计数或在预定次数和所保持的计数之间的差值。
根据各个实施例,联锁电路137可包括对器械10的使用者可见的一个或多个指示灯,以用于显示闭锁传感器开关136a-d中的至少一个的状况。关于此类指示灯的更多细节可见于名称为“ElectronicLockoutsandSurgicalInstrumentIncludingSame”的已公布的美国专利申请公开No.2007/0175956中,该申请全文以引用方式并入本文中。该申请还包括闭锁传感器开关136a-d的示例性安装构造和配置。
在图示实施例中,当闭锁传感器开关136a-d总体保持闭合开关状态时,单刀单掷继电器138通电。当继电器138通电时,电流流经继电器138,流过运行马达开关传感器110,并经由双刀双掷继电器140到达马达65,从而为马达65供电并使其正向旋转。根据各个实施例,由于继电器138的输出一旦被通电就将继电器138保持在通电状态,直到继电器132通电,因此联锁电路137将不会用来在马达165启动后阻止其操作,即使联锁传感器开关136a-d中的一个或多个随后保持断开开关状态。然而在其它实施例中,可能有必要或换句话讲希望连接联锁电路137和继电器138,使得一个或多个闭锁传感器开关136a-d必须保持闭合开关状态,以便在马达165启动后维持其操作。
马达的正向旋转使得环朝远侧运动,从而在各个实施例中禁用止动马达传感器开关142。由于开关142是常闭的,因此连接到开关142的螺线管141可以通电。螺线管141可为常规的推式螺线管,该螺线管在通电时造成柱塞(未示出)轴向延伸。柱塞的延伸可操作以将闭合触发器18保持在回缩位置,由此防止砧24在击发操作进行过程中(即在开关142未被致动时)打开。在螺线管141断电时,柱塞回缩,使得可能手动释放闭合触发器18。
当致动构件部分达到其行程最远端时,换向马达开关130将被启动,从而闭合开关130并为继电器132供电。这使继电器132呈现其通电状态(图11中未示出),该状态使电流绕过联锁电路137和运行马达电阻器开关110而流向常闭双刀双掷继电器140,并经由继电器140流回到马达65,但其方式使得马达65反向旋转。由于止动马达传感器开关142是常闭的,因此电流将流回到继电器132以保持其通电,直到开关142断开。当刀32完全回缩时,止动马达传感器开关142启动,使得开关142断开,从而将马达65断电并对螺线管141断电。
在图15所示实施例中,采用与回缩触发器121(图15未示出)交接的常闭回缩开关137。当回缩开关137启动时,其断开以停止流向马达65的电流。在可供选择的实施例(图15A)中,常闭回缩开关137可替换成与回缩触发器121交接的可变电阻器137’。在这样的实施例中,当回缩触发器121未被按下时,可变电阻器的电阻最小,以允许最大的电流流向马达65。当被按下时,电阻与按压力成比例地增加,以减小到马达的电流。此类可变电阻器也可替换成如上所述回缩开关131(见图15B)。
防止动力内切割器的意外致动:动力系统的引入使得装置功能不再受限于使用者所能施加的力,但击发循环的意外启动可能成为更普遍的问题。“撞击”启动控制件并使器械开始击发将变得越来越容易,从而释放仓的闭锁,或者甚至在使用者还未察觉时即已开始击发而将其“推挤”到组织上。授予Swayze等人的名称为“ElectronicLockoutsandSurgicalInstrumentIncludingSame”的美国专利No.7,644,848中公开了各种闭锁构造,该专利的公开内容全文以引用方式并入本文中。为了消除该问题,可使用辅助解锁启动开关或按钮来解锁击发机构。这与用于动力锯行业和军事的防止意外致动的两种开关系统非常相似。该辅助开关可释放击发触发器上的锁或仅向控制件供电。
如上所述,在使用双行程电动器械时,操作者首先向后拉动并锁定闭合触发器18。图16和图17示出了将闭合触发器18锁定到柄部6的手枪式握把部分26的方式的一个实施例。在图示实施例中,手枪式握把部分26包括钩150,其由扭转弹簧152偏置以围绕枢轴点151逆时针旋转。此外,闭合触发器18包括闭合杆154。当操作者拉近闭合触发器18时,闭合杆154接合钩150的倾斜部分156,从而向上(或者图16和图17中的顺时针)旋转钩150,直到闭合杆154完全通过倾斜部分156、进入钩150的下陷的凹口158中,从而将闭合触发器18锁定到位。操作者可通过下推位于手枪式握把26的后侧或对侧上的滑动释放按钮160来释放闭合触发器18。下推滑动释放按钮160使钩150顺时针旋转,从而使闭合杆154从下陷的凹口158释放。用于可释放地锁定闭合触发器18的其它构造在美国专利No.7,422,139中有所公开,该专利以引用的方式并入本文中。
如在图16和图17中可看出,在各个实施例中,闭合锁开关151可安装在钩150中,使得其仅当钩150被闩锁到位时才启动。然而,闭合锁开关151可安装在手枪式握把部分26中以便在闭合触发器18锁定到位时由闭合触发器18启动。在另外的可供选择的实施例中,闭合锁开关151安装到端部执行器,使得其仅当砧或其它可运动部分处于“闭合”位置时启动。不论闭合锁开关151的具体位置如何,在各个实施例中,闭合锁开关均为常开开关,其将在闭合触发器18锁定或以其它方式将端部执行器操纵到“闭合”位置时闭合。
图18是根据本发明的各个实施例的器械10的电路的示意图,示出了闭合锁开关151的使用。如在该图中可看出,即使存在仓,也不允许电流从电池64流至马达65,除非闭合锁开关151闭合。因此,马达65将不能操作,除非闭合触发器处于锁定的闭合位置,这也反映出端部执行器处于闭合状态。
各个实施例还可包括起动开关153,起动开关153必须由外科医生启动,然后才允许电流从电池64流至其它电路部件并最终流至马达65。起动开关153是常开的,并且可位于柄部6上的常规位置处。参见图1。因此,在这些实施例中,在由外科医生闭合起动开关153之前,即使端部执行器包含仓并且闭合触发器18锁定在闭合位置,也不允许电流流至马达65。在可供选择的实施例中,起动开关153可包括机械开关,其防止击发触发器20朝手枪式握把部分物理地旋转,除非开关153运动到致动位置。
动力内切割器的主动可调缝钉高度:多年来一直在寻求可根据组织厚度和类型来调节缝钉高度。最近,提交于2005年9月21日的美国专利申请序列号11/231,456(现在的美国专利No.7,407,078)和提交于2006年9月29日的美国专利申请序列号11/540,735(现在的美国专利No.7,467,740)大体涉及一种允许利用装置中的较厚组织引起的荷载扩大器械间隙的柔性联接构件或支撑件,这两份专利的公开内容均全文以引用方式并入本文中。这种“被动”可变缝钉高度使得组织的厚度形成较高的缝钉形状。
在器械中引入电源为使用电来改变动态联接元件中内部元件的高度创造了条件,可以由外科医生或设置所需高度的器械“主动”改变缝钉高度。该内部元件可为形状记忆材料,并且电可改变其温度,从而使其根据预设构形改变其物理高度。另一种可行方法是加入电活性聚合物(EAP),在电场引入的情况下,使其改变其高度和宽度。另外,第三实施例是使用传统的线性电步进元件,该元件可使小的可调螺杆元件在联接杆(couplingbeam)范围内棘齿接合,从而调节其高度。
更具体地且参照图19和图20,本发明的各个实施例的端部执行器12在剖视图中显示为砧24处于闭合或夹紧位置。如图可见,切割器械或刀32具有下致动器部分37,下致动器部分37具有构造成与螺杆轴36螺纹接合的带螺纹的套管或螺母部分37’。此外,翅片39从螺母部分37的每个侧边横向地突出以面对通道22的对应滑动部分23。如在图19中还可看出的,刀32具有上致动器部分41,其尺寸设计成容纳在砧24中的纵向T形槽43内。如在图19中可看出,一对上定位销41’从刀32的上致动器部分41的每一侧横向突出。每个上定位销41’构造成伸入设置在砧24中的T形槽43的对应部分中。因此,当刀32被朝远侧驱动通过端部执行器12时,翅片39和定位销41’用来将砧24和仓34之间的空间的量限制到预定空间的最大量。
本发明的各个实施例设有用于调节在砧24和安装在通道22内的仓34之间的空间的量的装置。例如,在一些实施例中,每个翅片39支撑滑块触点45,滑块触点45用于与安装在通道22的每个滑动部分23内的对应电触点47滑动接触。电触点47是细长的且在通道22内延伸,从而当刀32在通道22内被驱动时,滑块触点45始终与其对应的电触点47保持接触。电触点47连接到电源或电池64且构造成当马达65被供电以朝远侧驱动刀32时接收来自电源或电池64的电流。另外在某些实施例中,电响应于高度调节构件49安装到每个定位销41’,如图19所示。高度调节构件49电联接到滑块触点45以接收来自其的电流。在各个实施例中,高度调节构件49可包括形状记忆材料,该材料在通电时由于预设配置而改变其物理高度。因此,根据所接收的电流量,高度调节构件49可朝仓34延伸并推压砧24,从而减小仓34和砧24之间的空间量。此类材料的该量与接收的电流量成比例且为已知的。可采用控制电路(未示出)来控制伸展量和因此在砧24和仓34之间的空间的量。在其它实施例中,高度调节材料包括电活性聚合物(EAP),其保持在销41中的凹口内或以其它方式附接到该凹口。
图21示出了类似于图19所示实施例的另一个实施例。然而,在该实施例中,高度调节构件49安装在砧24内且通过直接附接到电源的导体从电源接收电流。因此,在该实施例中,不需要如上所述的触点43和45。
图22示出了可选的刀组件32’,其与如上所述的刀组件32基本上相同,不同的是定位销41’安装到单独的上致动器部分302,上致动器部分302能在竖直方向“VD”上相对于刀组件32’的下部300选择性地运动。第二马达304可安装到下部300且具有导螺杆306,导螺杆306螺纹接合上保持器部分302的螺母部分308。上保持器部分具有T形舌状部分310,其可滑动地伸入下部300中的对应形状的槽312,以防止上保持器部分302相对于下保持器部分300的旋转,同时允许上保持器部分302相对于下保持器部分300竖直运动。因此,上保持器部分302和下保持器部分300之间的距离可通过对第二马达304供电而调节。因此,如果外科医生想要减小砧24和仓34之间的空间量,则第二马达304被供电以沿第一方向旋转,从而朝下保持器部分300拉动上保持器部分302。然而,如果外科医生希望增加砧24和仓34之间的空间量,则第二马达304沿相反方向旋转。
本发明的各个实施例包括端部执行器照明方法和用于在采用电动内切割器时照亮手术部位的方法。目前,当端部执行器处于部署位置或接近该位置时,由于存在相邻结构投射的阴影以及甚至整个端部执行器位于另一结构之后,外科医生有时难以观察治疗部位。图23以大体形式示出了本发明的各个实施例的外科缝合器400的远端402,其包括砧404、仓主体406和通道408。如图所示,能够在仓主体406的末端设置附加光源410,以照明组织401。该光源410可为将电能转换为光的实际装置的任何组合,包括但不限于半导体(例如LED)、常规白炽光或白炽灯泡、电致发光装置或激光器,其可由被支撑在器械柄部中的电池供电或在其它实施例中由交流电供电。这样的装置将允许外科医生不仅直接照亮治疗部位,而且能够为结构提供背光以看到例如脉管的内部部分,并有利于使用穿过传统镜头的激光指示器以向其他人指出所关注的区域。
在各个实施例中,在仓主体406的背部设置有构造成接合通道408内的触点422的一个或多个触点420。参见图24。这使得外科医生可经由定位在柄部430上的开关向触点组供电,从而提供所需的光410。该开关甚至可具有可变的强度,如本文所述可控制主装置致动速度的开关。用于照亮附接到圆形外科缝合器的砧的末端的其它照明装置公开于2010年4月22日公开的名称为“SurgicalStaplingInstrumentWithApparatusForProvidingAnvilPositionFeedback”的美国专利申请公开No.US2010/0096435A1中,该申请的全部公开内容以引用方式并入本文中。
公开于2007年8月2日的名称为“SurgicalInstrumentHavingaFeedbackSystem”的美国专利申请公开No.2007/0175949A1(其全部公开内容以引用方式并入本文中)在该公开的图45-47中还公开了输出显示器,该显示器主要能显示端部执行器的这种位置反馈、闭锁状况、击发数等。这将最小化对于使用者更困难的问题中的一个,即装置状况的识别,特别是在未致动装置的情况下装置的闭锁状况。其它对使用者有益的反馈是对仓加载时的状态的即时反馈。如上述应用中,这可汇总到柄部430上的闭锁指示。指示灯432(例如LED、玻璃灯泡、LCD、语音报警器、振动器等)可仅仅与仓闭锁装置或机构的状态相关,以使其向外科医生提供该信息。该LED可位于柄部430上。参见图26。作为另外一种选择,指示灯434可位于远端402附近,能够向外科医生和装载员提供仓是否“准备就绪”的即时信息。参见图25。这可由与机械闭锁直接相关的开关或触点组完成。开关或触点使电路闭合,以使指示灯提供适当信息。该闭合触点组可通过滑块(美国专利申请公开No.US2007/0175958的部件33)内的导电元件,并且两个触点可位于通道(部件22)附近。检测闭锁状况的另一种方式是间接通过器械状况(实例1:加载的仓和没有击发意图将表明闭锁未接合;实例2:击发的器械和没有安装新仓将表明闭锁接合;等等)。另一个实施例是在仓自身上设置LED或视觉指示。仓按扣到位时,向仓供电的触点就被建立。如果仓被击发,不仅机械闭锁系统停止刀的推进,而且仓电路点亮仓上的LED,从而在内镜监视器上通知外科医生仓已被闭锁。这可通过在仓内放置小电池或其它电荷存储器进一步扩展,以消除与主装置电源连接的需要。还可设置仓电路,在装置闭合时点亮闭锁灯,从而通知使用者装置中有用过的仓。
对动力关节连接和仓颜色的指示反馈:指示所装仓的类型(颜色)和关节转角被认为对外科医生是有用的。关节转角指示可通过多种方式实现,包括例如以LED弧显示的数字或图形方式。该指示的位置可在柄部上的合适位置或在临近端部执行器的装置的轴上。端部执行器反馈可为主动方式或被动方式。主动方式是点亮附加的LED来表示角度。被动方式可为仅示出半个点亮的圆饼,因此外科医生可凭直觉知道端部执行器的关节运动状况。随着对外科的深入探究,越来越显而易见,外科医生需要注视手术部位,而不是器械的柄部。还开始理解到外科医生对于来自装置的完整的状态反馈的需求。关节转角可被图解说明为关节接头自身的一部分。可用指示灯、LED等表示不同的角,或者甚至可用小型LCD来指示角度。这使得外科医生可得到偏离平角的角度的一些反馈,因此他/她能够在移除和再插入后轻易导航回到该角度。另一个问题是对装置中的仓的颜色的“明显”指示。这可通过在端部执行器或仓上的色码光阵列来实现。该信息还可传回柄部进行“冗余”显示,以确保钳口中的仓类型的混淆可能性成为最小。另一个改进可包括连接到仓邻近板面的小片簧触点,指示钳口内是否已达到最小组织压力。该最小压力起码可以指示是否将厚组织仓用在了薄组织应用中,如果板面上没有足够的组织压力将不会发光。
可能需要用于引入非无菌电池组的方法(如果可编程逻辑器件成为关键的客户需求,可以将电子器件与电池组集成)。对于在独立消毒的可再用装置中插入非无菌电池组,整形钻行业中已有专利。该创新旨在通过如下方式改进原有概念:在插入非无菌电池组的过程中,使用一次性装置无菌包装以保护器械的无菌性。另一个改进是具有设计在器械内的“舱口”门,并且该门能够在插入电池组后但在所述装置从最终无菌包装中取出前闭合。然后这个舱口会“容纳”可能污染无菌手术区域的非无菌电池。本文的方法将包括具有打孔区域的附加包装层,可通过该打孔区域推入电池,推入方式使外层破裂并让电池穿过,或随着电池的电极组一起通过,仅在完全插入时被电池的可外露针头扎破。该方法的替代方法是让枪体的内部端子(位于电池保护腔体内的深处)刺破无菌隔离并插入电池组的针孔内。然后,可通过无菌电池组密封系统将舱口闭合。枪体然后可如任何无菌装置那样正常地转移到无菌区域。
定位器实施例I线性编码器和马达参数的载入控制:美国专利6,646,307和6,716,223公开了用于测量旋转和相关扭矩来控制马达参数的机构,以及根据对端部执行器配置和负载的识别来优化那些参数的机构。美国专利申请公开No.2007/0175958在图8-13中示出了通过使用主轴的螺纹长度的方法,以及如何使用此类线性运动控制来控制触发器的位置。对于电子线性控制方法,可使用相同类型的方法。按下至少一个弹簧偏置的柱塞,在这样的机械作用下,端部执行器可识别其长度和类型,可对柄部确认执行器的类型以及可让马达运行的长度。马达的旋转可从旋转运动转换为线性齿条或缆索运动,这然后可用来调节马达的电压、电流和速度,以改变所需的控制滑块的线性运动。该控制滑块然后可直接联接到刀驱动运动。该控制滑块可具有分立或连续的“停止”位置,这些位置由柱塞标定器标示为回缩前的最大“前行”线性位移。
具有线性驱动的模块式装载的识别:外科器械的有用特征是识别已附接到器械的端部执行器的能力。对于动力外科缝合器,可附接多个不同类型的端部执行器。另外,一种端部执行器可具有至少一种可选择性地使用或启用的功能和/或特征。本发明公开了用于识别已附接的端部执行器的方法。应当注意,下文提及的端部执行器的“类型”不限于以机械、气动式或液压方式联接的端部执行器。通过检测该端部执行器,所述器械可执行不同动作,调节操作参数,并指示可用功能等。
端部执行器附接到器械时构成电连接。器械与端部执行器连通并读取几种信号中的至少一种。开关位置或触点位置指示何种类型的端部执行器被装上。测量无源元件的阻抗,结果指示何种类型的端部执行器被装上。
端部执行器与器械具有射频连接,数据沿至少一个方向在端部执行器和器械之间传递。
端部执行器与器械具有声学连接,数据沿至少一个方向在端部执行器和器械之间传递。
端部执行器与器械具有光学连接,数据沿至少一个方向在端部执行器和器械之间传递。
端部执行器具有机械连接,该连接将元件(例如开关或触点)接合到可识别该元件的器械中,从而数据沿至少一个方向在端部执行器和器械之间传递。
虽然已经通过描述几个实施例举例说明了本发明并且已经相当详细地描述了示例性实施例,但是申请人不旨在将权利要求的范围约束或以任何方式限制到这些细节中。本领域技术人员可容易看出其它优点和修改形式。
例如,虽然上述实施例对于采用内窥镜的外科切断和缝合器械10具有优点,但可以在其它临床手术中使用类似的实施例。普遍认为,内窥镜式手术比腹腔镜式手术更常见。因此,本发明对内窥镜式手术和设备进行了讨论。但是,本文使用的术语,例如“内窥镜式”不应被理解为将本发明限于仅结合内窥镜式管(即,套管针)使用的外科器械。与此相反,本发明据认为可用于进入受限于小切口的任何手术中,包括但不限于腹腔镜式手术以及开腹手术。
据述以引用方式全部或部分地并入本申请的任何专利、公布、或其它信息仅在所并入的材料不与本文所述的现有定义、陈述、或其它公开材料相冲突的程度下并入本申请。同样地,本申请明确阐述的公开内容取代了以引证方式并入本申请的任何冲突材料。
尽管已经将本发明作为示例性设计进行了描述,但还可以在本公开的精神和范围内对本发明进行修改。因此本专利申请旨在涵盖采用本发明一般原理的任何变型形式、用途或适应形式。此外,本专利申请旨在涵盖偏离本公开但仍在本发明所属领域中的已知或惯有实践范围内的变型。

Claims (17)

1.一种外科紧固件设备,包括:
a.柄部;细长轴,所述细长轴具有附接到所述柄部的近端和从所述细长轴延伸的远端;端部执行器,所述端部执行器包括在所述端部执行器的近端处枢转并且能够在打开位置和闭合位置之间运动的一对钳口;以及包含多个外科紧固件的仓,所述仓附接到所述端部执行器;
b.用于部署所述外科紧固件的电动致动器,所述致动器包括电源和马达;
c.调节装置,其响应于从所述电源施加于其的电流调节所述钳口处于所述闭合位置时所述钳口之间的间距的量。
2.根据权利要求1所述的外科紧固件设备,其中所述端部执行器包括:
能够可操作地支撑其中的所述仓的细长通道;以及
可枢转地联接到所述细长通道并且能够在所述打开位置和闭合位置之间选择性地枢转的砧。
3.根据权利要求2所述的外科紧固件设备,其中所述致动器包括致动器部分,所述致动器部分能够响应于从所述马达接收到的启动运动而在所述端部执行器内运动,所述致动器部分具有下致动器部分和上致动器部分,所述下致动器部分可滑动地接合所述细长通道,所述上致动器部分具有能够可滑动地接合所述砧的一对保持器构件。
4.根据权利要求3所述的外科紧固件设备,其中所述调节装置包括在所述保持器构件的每一个上的高度调节构件,每个所述高度调节构件均被定位在所述保持器构件和所述砧的对应部分之间并且与所述电源电连通,每个所述高度调节构件均具有响应于来自所述电源的电流而增加的厚度。
5.根据权利要求3所述的外科紧固件设备,其中所述调节装置包括在所述砧上的高度调节构件,所述高度调节构件对应于所述上致动器部分上的所述保持器构件中的每一个,每个所述高度调节构件均被定位在所述对应的保持器构件和所述砧之间并且与所述电源电连通,每个所述高度调节构件均具有响应于来自所述电源的电流而增加的厚度。
6.根据权利要求4所述的外科紧固件设备,还包括:
处于所述细长通道中并与所述电源电连通的至少一个电触点;以及
位于所述下致动器上的至少一个滑动触点,所述至少一个滑动触点与所述细长通道中的所述至少一个电触点中对应的一个滑动电接触并与所述高度调节构件电连通以向所述高度调节构件传输所述电流。
7.根据权利要求3所述的外科紧固件设备,其中所述上致动器部分能够相对于所述下致动器部分运动。
8.根据权利要求7所述的外科紧固件设备,其中所述调节装置包括用于使所述上致动器部分相对于所述下致动器部分电运动的装置。
9.根据权利要求8所述的外科紧固件设备,其中用于电运动的所述装置包括第二电动马达,所述第二电动马达联接到所述上致动器部分和下致动器部分并与所述电源电连通。
10.根据权利要求9所述的外科紧固件设备,还包括:
处于所述细长通道中并与所述电源电连通的至少一个电触点;以及
位于所述下致动器上的至少一个滑动触点,所述至少一个滑动触点与所述细长通道中的所述至少一个电触点中的对应的一个滑动电接触并与所述第二电动马达电连通。
11.根据权利要求4所述的外科紧固件设备,其中所述高度调节构件包含电活性聚合材料。
12.一种外科紧固件设备,包括:
柄部;
可操作地联接到所述柄部的端部执行器,所述端部执行器包括:
能够支撑其中的仓的细长通道;
砧,所述砧被可运动地支撑在所述细长通道上以用于选择性地朝所述细长通道运动到闭合位置以及远离所述细长通道运动到打开位置,在所述砧中具有细长槽;
致动器构件,所述致动器构件被可运动地支撑在所述细长通道内并能够在所述细长通道内从未致动的近侧位置选择性地运动到致动位置,所述致动器构件包括:
可滑动地接合所述细长通道的下致动器部分;
能够突出到所述细长槽中的上致动器部分;
保持器构件,所述保持器构件从所述上致动器部分的每个侧边沿基本上横向于所述砧中的所述细长槽的方向突出;和
高度调节构件,所述高度调节构件位于每个所述保持器构件上,所述高度调节构件包括响应于施加于其的电流增加的厚度,以在所述砧处于所述闭合位置中时选择性地调节所述砧与所述细长通道之间的间距。
13.根据权利要求12所述的外科紧固件设备,还包括:
处于所述细长通道中并与电源电连通的至少一个电触点;以及
位于所述下致动器部分上的至少一个滑动触点,所述至少一个滑动触点与所述细长通道中的所述至少一个电触点中对应的一个滑动电接触并与第二电动马达电连通。
14.根据权利要求12所述的外科紧固件设备,其中所述高度调节构件位于邻近所述细长槽的每个侧边的所述砧上以用于与所述保持器构件呈面对关系。
15.根据权利要求14所述的外科紧固件设备,还包括:
处于所述细长通道中并与电源电连通的至少一个电触点;以及
位于所述下致动器部分上的至少一个滑动触点,所述至少一个滑动触点与所述细长通道中的所述至少一个电触点中对应的一个滑动电接触并与第二电动马达电连通。
16.根据权利要求12所述的外科紧固件设备,其中所述高度调节构件包含电活性聚合材料。
17.根据权利要求14所述的外科紧固件设备,其中所述高度调节构件包含电活性聚合材料。
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