CN102368958A - 动力手术缝合器的改进 - Google Patents
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Abstract
本发明公开了一种外科手术紧固件设备，所述外科手术紧固件设备包括：手柄和细长轴，所述细长轴具有连接于所述手柄的近端和从其伸出的远端；端部执行器，所述端部执行器包括在其近端处枢转并且能够在打开位置和关闭位置之间运动的一对钳口；以及容纳多个外科手术紧固件的钉仓，所述钉仓连接到所述端部执行器；用于展开所述外科手术紧固件的电动致动器；电力地起动的反向机构，所述电力地起动的反向机构用于将所述细长构件从所述端部执行器内的最远侧位置运动到近侧位置，在所述细长构件运动到所述最远侧位置以后，通过将所述扳机运动到所述打开位置，所述电力地起动的反向机构将所述细长构件向近侧运动，并且其中在所述反向机构起动后，通过将所述扳机返回到其关闭位置，可使所述细长构件的近侧运动停止。
Description
相关专利申请的引用
本专利申请要求提交于2009年2月6日的、授予Ryan J.Laurent的、名称为“Motor-Driven Surgical Stapler Improvements”(电动手术缝合器的改进)的美国临时申请No.61/150,391的优先权。
背景技术
适于内窥镜应用的手术缝合器的例子在美国专利No.5,465,895(以引用方式并入本文中)中有所描述，该专利公开了具有不同闭合和击发动作的内镜切割器。电动手术缝合器的例子为美国专利公开No.2007/0175958(据此以引用方式并入本文中)，其中本文摘录的部分详细说明了其基本功能、改进、背景技术以及组件。最后公开了该系统的其他改进。
引用US2007015958的背景技术和发明内容部分-临床医生使用该装置时能够在击发前使钳口构件在组织上闭合以定位组织。一旦临床医生确定钳口构件正确地夹住了组织，临床医生就可用单击发冲程或多击发冲程(取决于装置)来击发手术缝合器。击发外科缝合器使得组织被切断并缝合。同时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，临床医生可通过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，相对钳口可能被拉得太近，特别是在它们的远端夹拢，从而不能在切断组织内有效形成闭合缝钉。另一个极端情况是，夹住的过量组织可能导致束缚和不完全击发。
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之一在于这样的追求，将击发力(FTF)降低到所有或大多数外科医生都能操控的程度。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15-30Ibs)内完成切割/缝合循环。如果在装置手柄中感受到的力感觉过大或者由于一些其他临床原因，他们通常还希望保持对缝钉展开的控制并能够随时停止。这些对于使用者的反馈作用，未能在现有电动内镜切割器中适当实现。因此，对于切割/缝合操作仅仅通过按一下按钮来致动的电动内镜切割器，医生还未普遍接受。
发明内容
在一个总体方面，本发明涉及电动手术切割和紧固器械，所述器械能够向使用者提供关于端部执行器的位置、力和/或展开的反馈。在各种实施例中，该器械还允许操作员控制端部执行器，包括能够在需要时停止展开。该器械能够在其手柄中包括两个扳机(闭合扳机和击发扳机)，具有分开的执行动作。当该器械的操作员回扣闭合扳机时，端部执行器可以夹住定位于端部执行器中的组织。然后，当操作员回扣击发扳机时，马达可借助齿轮传动链为可旋转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。
在各种实施例中，该器械可包括具有加载力反馈和控制的动力辅助系统，以减少操作员施加的所需击发力，从而完成切割操作。在此类实施例中，击发扳机可以啮合到主传动轴组件的齿轮传动链中。通过这样的方式，操作员可体验与施加到切割器械上的力有关的反馈。也就是说，击发扳机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，因为击发扳机被接入齿轮传动链，操作员施加的力可加到作用于马达的力上。
根据各种实施例，当击发扳机回缩适当的量(如5度)时，可致动通/断开关，向马达发送以指定速率旋转的信号，从而开始致动传动轴组件和端部执行器。根据其他实施例，可以使用比例传感器。比例传感器可以向马达发送以指定速率旋转的信号，该速率与操作员加到击发扳机上的力成比例。通过这样的方式，击发扳机的旋转位置与切割器械在端部执行器中的位置(例如，完全展开或完全回缩)大致成比例。操作员还可以在冲程的某一点停止回扣击发扳机以停止马达，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，完全展开位置)。因此，传感器可提供适应控制系统，用以在马达、齿轮传动链和端部执行器的闭环系统之外控制端部执行器的展开。
在其他实施例中，击发扳机可不被直接接入用于致动端部执行器的齿轮传动链中。在此类实施例中，可用第二马达对击发扳机加力，以模拟端部执行器中切割器械的展开。可根据由旋转编码器测定的主传动轴组件的旋转增量控制第二马达。在此类实施例中，击发扳机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/断开关或比例开关控制主马达(即为主传动轴提供动力的马达)。
在各种具体实施中，端部执行器能够在端部执行器的基座使用螺旋传动螺杆来驱动切割器械(例如割刀)。端部执行器还可以包括用于缝合切断组织的钉仓。根据其他实施例，可使用其他方法紧固(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仓槽，该仓槽具有夹紧构件(例如砧座)，该夹紧构件可枢转连接到该仓槽，以夹紧位于端部执行器中的组织。使用者可通过回扣闭合扳机来起动端部执行器的夹紧动作，所述闭合扳机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，操作员就可以通过回扣独立的击发扳机来起动切割操作。这可使得切割器械沿着仓槽纵向行进，以切割端部执行器夹住的组织。
在各种具体实施中，所述器械可包括用于致动端部执行器的可旋转主传动轴组件。此外，主传动轴可以包括关节接头，以使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。
本发明的其他方面涉及用于将闭合扳机锁定到手柄下部的手枪式握把部分的各种机构。此类实施例将手柄中位于扳机正上方和正后方的空间空出来，用于器械的其他部件，包括齿轮传动链和机械闭合系统的部件。
本文的公开内容示出了具体实施电池供电的齿轮驱动独立式内镜缝合装置的方法。
附图说明
图1是根据本发明的手术缝合器的远端的透视图。
图2是根据本发明的手术缝合器的远端的透视图，其中钉仓已从仓槽中移除。
图3是与图1类似的根据本发明的手术缝合器的远端的视图，图中示出了闭锁指示灯。
图4是根据本发明的手术缝合器的近端的透视图。
具体实施方式
具有电动内镜切割器的端部执行器照明方法/手术部位照明：目前，当端部执行器处于展开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1示出了根据本发明的手术缝合器1的远端3，其包括砧座11、钉仓主体7以及仓槽13。如图所示，能够在钉仓主体7的末端设置附加光源5，以照明组织9。该光源可为任何将电能转化为光能的实用装置的组合，所述实用装置包括但不限于半导体(例如LED)、传统白炽灯或灯丝灯泡、电致发光(器件)或激光器。这将使得外科医生不仅可以直接照亮治疗部位，还可以为结构提供背光以观察如脉管系统等内部组成，或者采用激光笔时外科医生可以通过传统观察镜区分出所关注的区域和其他区域。
操作非常简单，将钉仓7后部的一个或多个触点21与仓槽内的触点23接合即可。这使得外科医生可以通过位于手柄31上的开关为触点组通电，从而提供所需的光。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。
如上所述，美国专利公开2007/0175949还在图45-47中公开了输出显示内容，可显示端部执行器的位置反馈、闭锁状态、击发次数等。这将最大程度地为使用者解决较为棘手的问题之一，即在不致动装置的情况下识别装置状态，尤其是装置的闭锁状态。其他对使用者有益的反馈是对钉仓加载时的状态的即时反馈。如上述应用中，这可汇总到手柄31上的闭锁指示。指示灯33(例如LED、玻璃灯泡、LCD、语音报警器、振动器等)可仅仅与钉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可位于手柄上。作为另外一种选择，指示灯35可位于远端3附近，能够向外科医生和装载员提供钉仓是否“准备就绪”的即时信息。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板(专利公开20070175958的件33)内的导电元件，并且两个触点可位于仓槽(件22)附近。检测闭锁状态的另一个方法是通过器械状态来间接检测(实例I：已装载钉仓而不打算击发的状态可指示为“未进入闭锁”；实例2：器械已击发且未安装新钉仓的状态可指示为“已进入闭锁”；等等。)另一个实施例是在钉仓自身上设置LED或视觉指示。钉仓扣搭到位时，向钉仓供电的触点就被建立。如果钉仓被击发，不仅机械闭锁系统停止割刀的推进，而且钉仓电路点亮钉仓上的LED，从而在内镜监视器上通知外科医生钉仓已被闭锁。这可通过在钉仓内放置小电池或其他电荷存储器进一步扩展，以消除与主装置电源连接的需要。还可设置钉仓电路，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钉仓。
对动力关节连接和钉仓颜色的指示反馈：指示所装钉仓的类型(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若干方式实现，包括例如以LED弧显示上的数字或图形方式。该指示的位置能够在手柄上的合适位置或设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。被动方式可以是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。随着对外科手术的深入探究，越来越显而易见，外科医生需要注视手术部位，而不是器械的手柄。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“明显”指示何种颜色的钉仓在装置中。这可通过端部执行器或钉仓上的色码灯阵列实现。该信息还可传回手柄进行“冗余”显示，以确保钳口中的钉仓类型的混淆可能性成为最小。另一个改进可包括连接到钉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钉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。
电内镜切割器的自动推进和回缩：缝合器的运行有若干步骤，这些步骤必须按确定顺序完成。一旦闭合扳机被夹紧，下一必要步骤就是致动击发循环。致动后，下一顺序步骤是系统的回缩。系统除使用者控制外还包括动力源(即，电池或气动)，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。可添加内部开关或电路，以便于这些步骤自动开始。下一个挑战是让使用者能够直觉地推迟、减慢或停止自动执行。例如，可使用在如11/344,035所述触觉反馈装置中允许击发引发的相同的致动按钮，通过使用者在回扣过程中按下该按钮，来减慢或停止自动返回系统。一旦按钮上的压力移除，自动返回将重新开始。在系统不需要按钮进行击发的情况下该按钮可用于自动击发，但是设有随割刀的运动而运动的控制件，使用者可按下该控制件来停止或减慢割刀的展开，然而如果系统看来运行正常则不需要按动。
防止意外致动I，防止动力内镜切割器的意外致动：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，但击发循环的意外起动可能成为更普遍的问题。“撞击”起动控制件并使器械开始击发将变得越来越容易，从而释放钉仓的闭锁，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。为了消除该问题，可使用辅助解锁起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。该辅助开关可以或者解开击发扳机上的锁或者只是给控制件通电。
非无菌电池在充当无菌隔离的无菌装置I包装中使用，以便于电池组的再利用：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关闭。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，推入方式要么是使外层破裂并让电池穿过，要么是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关闭。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：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。美国专利公开20070175958在图8-13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扳机的位置。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，可对手柄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连接于割刀驱动运动。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重载的识别：外科器械的有效特征是识别已连接到器械的端部执行器的能力。对于动力手术缝合器，可连接若干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使能的功能和/或特征。本发明公开了用于识别已连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、气动式或液压方式连接的端部执行器。通过检测该端部执行器，所述器械可执行不同动作，调整操作参数，并指示可用功能等。
端部执行器连接到器械时构成电连接。器械与端部执行器通信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送。
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送。
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送。
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送。
动力内镜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整缝钉高度。最近的专利11/231,456和11/540,735涉及可使器械间隙随装置中较厚组织引入的负载而扩大的柔性连接构件或支撑件。这种“被动”可变缝钉高度让组织的厚度造成较高的缝钉形状。在器械中引入电源为使用电来改变动态连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连接杆(coupling beam)范围内棘齿接合，从而调节其高度。
Claims (1)
1.一种外科手术紧固件设备，包括：
a.手柄；细长轴，所述细长轴具有连接到所述手柄的近端和从其伸出的远端；端部执行器，所述端部执行器包括在其近端处枢转并且能够在打开位置和关闭位置之间运动的一对钳口；以及容纳多个外科手术紧固件的钉仓，所述钉仓连接到所述端部执行器；
b.用于展开所述外科手术紧固件的电动致动器，所述致动器包括电源和马达；所述致动器包括细长构件，所述细长构件延伸穿过所述轴，并且能够向远侧运动到所述端部执行器内以便展开所述缝钉和向近侧运动以退出所述端部执行器；
c.扳机，所述扳机连接到所述手柄并且具有打开位置和关闭位置；并且所述扳机用于在处于所述关闭位置时起动所述致动器；并且
d.电力地起动的反向机构，所述电力地起动的反向机构用于将所述细长构件从所述端部执行器内的最远侧位置运动到近侧位置，在所述细长构件运动到所述最远侧位置以后，通过将所述扳机运动到所述打开位置，所述电力地起动的反向机构将所述细长构件向近侧运动，并且其中在所述反向机构起动后，通过将所述扳机返回到其关闭位置，可使所述细长构件的近侧运动停止。
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- 2010-01-26 US US12/693,462 patent/US8245899B2/en active Active
- 2010-01-28 JP JP2011549197A patent/JP2012517289A/ja active Pending
- 2010-01-28 WO PCT/US2010/022365 patent/WO2010090943A1/en active Application Filing
- 2010-01-28 AU AU2010210798A patent/AU2010210798B2/en not_active Ceased
- 2010-01-28 CN CN201080014656.9A patent/CN102368958B/zh active Active
- 2010-01-28 BR BRPI1008192A patent/BRPI1008192A2/pt not_active Application Discontinuation
- 2010-01-28 CA CA2751448A patent/CA2751448C/en not_active Expired - Fee Related
- 2010-01-28 EP EP10702208A patent/EP2393432A1/en not_active Ceased
- 2010-01-28 RU RU2011136807/14A patent/RU2529375C2/ru not_active IP Right Cessation
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105163685A (zh) * | 2013-04-05 | 2015-12-16 | 索发有限公司 | 具有无菌包装的外科系统 |
| CN105163685B (zh) * | 2013-04-05 | 2018-08-07 | 索发有限公司 | 具有无菌包装的外科系统 |
Also Published As
| Publication number | Publication date |
|---|---|
| BRPI1008192A2 (pt) | 2016-03-01 |
| WO2010090943A1 (en) | 2010-08-12 |
| EP2393432A1 (en) | 2011-12-14 |
| US8245899B2 (en) | 2012-08-21 |
| US20110024479A1 (en) | 2011-02-03 |
| RU2011136807A (ru) | 2013-03-20 |
| CA2751448A1 (en) | 2010-08-12 |
| CA2751448C (en) | 2017-05-02 |
| CN102368958B (zh) | 2017-06-09 |
| AU2010210798B2 (en) | 2013-11-28 |
| RU2529375C2 (ru) | 2014-09-27 |
| JP2012517289A (ja) | 2012-08-02 |
| AU2010210798A1 (en) | 2011-08-25 |
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