CN101518460B - 用于外科设备的反馈和闭锁机构 - Google Patents
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Abstract
本发明公开了一种用于外科设备的反馈和闭锁机构。该外科设备特别适合于顺序地施加多个固定件到身体组织上并同时切割组织。手柄组件包括活动手柄。该活动手柄在致动冲程中可动。细长主体从手柄组件向远侧延伸并限定纵向轴线。该细长主体具有适合于可释放地接合关节连接和非关节连接的一次性装载单元类型的远端。致动轴至少部分地支撑在手柄组件内且安装用于响应致动手柄的操纵而沿纵向运动。能量启动的击发闭锁系统阻止外科设备在多种情况下的操作。
Description
技术领域
本申请涉及一种外科设备，更具体地，涉及一种与内窥镜外科设备一同使用的机构，该机构用于顺序地施加多个外科紧固件到身体组织上并可选地切割被固定的组织。
背景技术
首先抓取或夹紧组织在相对的钳口结构之间并随后用外科紧固件连接组织的外科装置在本领域是已知的。在一些器械中提供刀具来切割被紧固件连接的组织。紧固件典型地为外科缝钉的形式但也可利用两部分的聚合物紧固件。
出于该目的设计的器械可包括两个各自用来捕获或夹紧组织的细长构件。典型地，所述细长构件中的一个承载钉仓，该钉仓容纳布置成至少两个横向排的多个缝钉，而另一个细长构件具有钉砧，该钉砧限定在缝钉从钉仓被驱动时用于成形缝钉腿部的表面。通常，缝合操作通过沿纵向穿过钉仓行进的凸轮杆执行，该凸轮杆作用在缝钉推动器上以从钉仓顺序地射出缝钉。刀具可在缝钉排之间沿纵向行进以切割和/或打开缝钉排之间的缝合的组织。这种器械在例如美国专利No.3,079,606和美国专利No.3,490,675中公开。
之后在美国专利No.3,499,591中公开的缝合器在切口的每一侧上施加双排缝钉。这是通过提供一次性装载单元来实现的，在该一次性装载单元中，凸轮构件运动通过在两组交错的缝钉承载槽之间的细长引导路径。缝钉驱动构件位于该槽中并且以这样的方式定位，即，由沿纵向运动的凸轮构件接触以执行缝钉从一次性装载单元的钉仓中射出。这种缝合器的其它例子在美国专利No.4,429,695和No.5,065,929中公开。
上面描述的每一种器械都被设计用于传统的外科手术，其中，外科医生直接手动接近手术部位。然而，在内窥镜或腹腔镜手术中，通过小的切口或通过穿过皮肤中的小的进入伤口插入的窄的套管执行外科手术。为了满足内窥镜和/或腹腔镜外科手术的特定需要，内窥镜外科缝合装置已经得到了发展并且公开于例如美国专利No.5,040,715(Green等人)；No.5,307,976(Olson等人)；No.5,312,023(Green等人)；No.5,318,221(Green等人)；No.5,326,013(Green等人)以及No.5,332,142(Robinson等人)中。
一种类型的外科缝合设备能够与一次性装载单元(DLU)一同操作，该一次性装载单元被构造为在其中支撑钉仓以及刀具组件。一旦手术完成，丢弃整个DLU。设计这种器械是为了容纳DLU，这意味着具有为器械的每次击发提供“全新”的刀刃的优点。这种外科缝合设备和DLU的例子公开在Milliman等人的美国专利No.5,865,361中，该美国专利通过引用合并在此。
一些传统的内窥镜外科切割及缝合系统会出现在钉仓已经击发，无论是被部分击发或是完全击发之后闭锁失败的情形。此外，在这些传统的内窥镜外科切割和缝合系统中机械探测用尽的钉仓是不准确的。一些传统的内窥镜外科切割和缝合系统结合额外的机械和聚合部件，其能够克服在内窥镜装置的正常展开中产生的力并从而克服该闭锁机构。因此，在腹腔镜和/或内窥镜外科手术期间提供外科切割和缝合装置来使用将是非常有益的，该外科切割和缝合装置提供可靠的部分或全部用尽的钉仓闭锁功能。如果该装置能够使用具有各种尺寸和用途的DLU执行多种任务，例如用以缝合、夹住、切割和/或关节连接，并提供能量启动的连续闭锁系统和显示装置，也将是特别有益的。
发明内容
在一种实施方式中，外科缝合设备包括手柄组件，该手柄组件包括活动手柄。该活动手柄在致动冲程中可动。细长主体从手柄组件向远侧延伸并限定纵向轴线。该细长主体具有适合于可释放地接合关节连接和非关节连接的一次性装载单元类型的远端。致动轴至少部分地支撑在手柄组件内且其安装是为了响应致动手柄的操纵而沿纵向运动。能量启动的击发闭锁系统阻止外科缝合设备在多种情况下的操作。
本发明具体公开了以下内容：
(1).一种外科设备，包括：
手柄组件，其包括活动手柄，该活动手柄在致动冲程中可动；
细长主体，其从所述手柄组件向远侧延伸并限定纵向轴线，该细长主体具有能够可释放地接合关节连接和非关节连接的一次性装载单元类型的远端；
致动轴，其至少部分支撑在所述手柄组件中且其安装是为了响应所述致动手柄的操纵而沿纵向运动；
能量启动的击发闭锁系统，其阻止所述外科设备在多种情况下的操作；以及
直流电源。
(2).根据第(1)项所述的外科设备，其中，该能量启动的击发闭锁系统包括可操作地连接到锁定构件的螺线管，且其中所述螺线管由所述直流电源供电。
(3).根据第(1)项所述的外科设备，包括传感装置。
(4).根据第(3)项所述的外科设备，其中，该传感装置包括载荷传感器。
(5).根据第(4)项所述的外科设备，其中，该载荷传感器连接到所述活动手柄上。
(6).根据第(3)项所述的外科设备，其中，该传感装置包括连接到所述致动轴上的位置传感器。
(7).根据第(6)项所述的外科设备，其中，所述位置传感器包括编码器和感应线圈，其中，该编码器固定地连接到所述致动轴上并随其沿纵向运动。
(8).根据第(7)项所述的外科设备，其中，该编码器提供指示所述致动轴的纵向位置的输出。
(9).根据第(1)项所述的外科设备，包括：
一次性装载单元；以及
位于该一次性装载单元中的钉仓组件。
(10).根据第(9)项所述的外科设备，包括定位在所述一次性装载单元中的重载识别装置，该重载识别装置包括存储涉及该钉仓组件的状态信息的存储器。
(11).根据第(10)项所述的外科设备，其中，该重载识别装置存储钉仓状态信息，该钉仓状态信息选自包括以下各项的组：空钉仓存在状态、无钉仓存在、在刀具回缩之后存在部分用尽的钉仓、在松开外科设备之后存在部分用尽的钉仓，以及在外科设备的完全循环操作之后存在部分用尽的钉仓。
(12).根据第(10)项所述的外科设备，包括：
显示装置；以及
连接到显示装置的处理器，其中显示装置显示来自重载识别装置的钉仓状态信息。
(13).根据第(10)项所述的外科设备，包括位于一次性装载单元内的载荷传感器，其中该载荷传感器连接到显示装置和处理器以读取并显示施加到一次性装载单元的载荷。
(14).根据第(1)项所述的外科设备，其中，活动手柄包括：
挠性手柄部分；
击发释放部分；以及
击发开关。
(15).根据第(1)项所述的外科设备，包括松放开关。
(16).一种外科设备，包括：
手柄组件，其包括活动手柄，该活动手柄在致动冲程中可动；
细长主体，其从手柄组件向远侧延伸并限定纵向轴线，该细长主体具有能够可释放地接合关节连接和非关节连接的一次性装载单元类型的远端；
致动轴，其至少部分地支撑在手柄组件内且其安装是为了响应致动手柄的操纵而沿纵向运动；
能量启动的击发闭锁系统，其阻止外科设备在多种情况下的操作；
显示装置；
连接到显示装置的处理器；以及
直流电源，其连接到能量启动的击发闭锁系统、显示装置以及处理器。
(17).根据第(16)项所述的外科设备，其中，该能量启动的击发闭锁系统包括可操作地连接到锁定构件的螺线管，其中螺线管由直流电源供电。
(18).根据第(16)项所述的外科设备，包括连接到处理器和显示装置的传感装置。
(19).根据第(18)项所述的外科设备，其中，传感装置包括连接到致动轴的位置传感器。
(20).根据第(19)项所述的外科设备，其中，位置传感器包括编码器和感应线圈，其中该编码器固定地连接到致动轴上并随其沿纵向运动。
(21).根据第(20)项所述的外科设备，其中，编码器提供向显示装置的输出，所述输出指示致动轴的纵向位置。
(22).根据第(16)项所述的外科设备，其中，传感装置包括载荷传感器。
(23).根据第(16)项所述的外科设备，包括：
一次性装载单元；以及
位于一次性装载单元内的钉仓组件。
(24).根据第(23)项所述的外科设备，包括定位在一次性装载单元中的重载识别装置，该重载识别装置包括存储涉及该钉仓组件的状态信息的存储器。
(25).根据第(24)项所述的外科设备，其中，该重载识别装置存储钉仓状态信息，该钉仓状态信息选自包括以下各项的组：空钉仓存在状态、无钉仓存在、在刀具回缩之后存在部分用尽的钉仓、在松开外科设备之后存在部分用尽的钉仓，以及在外科设备的完全循环操作之后存在部分用尽的钉仓。
(26).根据第(23)项所述的外科设备，包括位于一次性装载单元内的载荷传感器，其中该载荷传感器连接到显示装置和处理器以读取并显示施加到一次性装载单元的载荷。
(27).根据第(16)项所述的外科设备，其中，活动手柄包括：
挠性手柄部分；
击发释放部分；以及
击发开关。
(28).根据第(11)项所述的外科设备，包括松放开关。
(29).一种方法，包括：
获得外科设备，其中该外科设备包括：
手柄组件，其包括活动手柄，该活动手柄在致动冲程中可动；
细长主体，其从手柄组件向远侧延伸并限定纵向轴线，该细长主体具有能够可释放地接合关节连接和非关节连接的一次性装载单元类型的远端；
致动轴，其至少部分地支撑在手柄组件内且安装用于响应致动手柄的操纵而沿纵向运动；以及
能量启动的击发闭锁系统，其阻止外科设备在多种情况下的操作；
给外科设备消毒；并且
将该外科设备存储在消毒容器中。
附图说明
在此参照附图描述各种优选的实施方式：
图1是本发明的外科缝合设备的一种实施方式的透视图。
图2是图1中所示的外科设备的侧视图。
图3是图1中所示的外科缝合设备在未致动位置的侧剖视图，其中未示出一次性装载单元。
图4是图3中所指示的细节区域的放大剖视图。
图5是用于图1中所示的外科缝合设备的电子反馈和闭锁的一种实施方式的示意图。
具体实施方式
现在参照附图详细描述本发明的内窥镜外科切割和缝合设备的优选实施方式，在附图中相同的附图标记表示若干视图的每个中的相同或相应的元件。
在附图中以及在下面的描述中，术语“近侧”按照惯例指的是缝合设备最靠近操作者的一端，而术语“远侧”指的是该设备最远离操作者的一端。还要认识到，为了方便和清楚，在此使用的诸如“竖直”、“水平”、“上”、“下”、“右”和“左”等空间术语是相对于附图而言的。但是，外科设备可以在许多方向和位置被使用，并且这些术语并不是限制性的和绝对的。
图1至4描述了用于切割和缝合的外科设备10，其包括能量启动的击发闭锁系统510(图3-5)。外科设备10的结构和一般操作在美国专利No.5,865,361中大体作了描述，其公开的内容通过引用结合入本文。因此，这里的详细描述将不在此讨论外科设备10的各种部件及其操作，除非对于描述能量启动的击发闭锁系统510的操作来说是必需的内容。
参照图1-4，根据一种实施方式，提供了用于顺序地施加多个紧固件到身体组织上并同时切割组织的外科设备10。外科设备10包括手柄组件12和细长主体14。外科设备10适合于容纳具有多排缝钉的一次性装载单元，该缝钉的线性长度大约在30mm至60mm之间。外科设备10还适合于容纳关节连接和非关节连接的一次性装载单元。在一种实施方式中，一次性装载单元或DLU 16可释放地固定到细长主体14的远端。DLU 16包括具有钉仓组件18和钉砧组件20的工具组件17，该钉仓组件18容纳多个外科缝钉，该钉砧组件20相对于钉仓组件18可动地固定。DLU 16能够施加测量长度为大约30mm到大约60mm的线性缝钉排。也可以设想DLU 16具有其它长度例如45mm的线性缝钉排。缝钉的高度可以是大约0.75mm、1mm、1.5mm或2mm并且可以是弯的(弧形的)或是直的。
在一种实施方式中，外科设备10还包括重载识别装置536，其用于感测定位在细长主体14内的DLU 16或外科设备10的DLU 16部分的类型。重载识别装置536包括带有存储器的固态电路或集成电路。该存储器可以是包括至少一个可编程或一次性可写的位或寄存器的只读存储器(ROM)。重载识别装置536可通过计算机538(图5)(例如控制器、处理器)读写。计算机538是常用的且包括任何可编程的状态机、硬件、软件、存储器以及必需的输入/输出装置。重载识别装置536存储涉及钉仓组件18的状态信息。例如，重载识别装置536可包含关于钉仓组件18是否已经被击发以及装载在钉仓组件18内的缝钉类型的信息。缝钉的类型包括长度为大约30mm、45mm或60mm的缝钉。每种长度类型的缝钉的高度可以是大约0.75mm、1mm、1.5mm或2mm。缝钉可以是弯的(弧形的)或是直的。除了关于缝钉类型的信息之外，重载识别装置536可包含与钉仓组件18的类型、钉仓组件18是否已经被击发以及是否被部分或完全地用尽相关联的信息。重载识别装置536在施加有来自诸如电池530(图5)的直流(DC)电源或诸如超级电容器的其它直流电源的电能时将存储在其中的信息提供到计算机538。识别钉仓组件18的类型以及击发状态的信息可显示在显示装置500上以有助于使用者。外科设备10内的重载识别装置536的操作在下面描述。
在一种实施方式中，外科设备10的细长主体14或DLU 16部分包括载荷传感器537。载荷传感器537连接到显示装置500和计算机538(例如处理器)。载荷传感器537测量施加到DLU 16的载荷，其能够被计算机538读取并显示在显示装置500上。载荷传感器537能够感测并测量施加到DLU 16的力和/或扭矩。载荷传感器537可定位在细长主体14中以感测和测量力或扭矩。载荷传感器537可定位在外科设备10的任意适合部位以感测与外科设备10的操作相关联的各种力或扭矩。
在一种实施方式中，外科设备10包括具有活动手柄和固定手柄的手柄组件12。活动手柄在致动冲程中可动以夹紧组织并实现缝钉从一次性装载单元的射出。细长主体从手柄组件12向远侧延伸并限定纵向轴线。具有齿条的致动轴通过棘爪机构与活动手柄组件12可操作地相关联。致动轴的远端与控制杆连接，该控制杆具有适合于可操作地接合位于一次性装载单元内的轴向驱动组件的远端。在所示实施方式中，手柄组件12包括固定手柄构件22、活动手柄构件24以及筒形部分26。转动构件28优选地安装在筒形部分26的前端以便于细长主体14相对于手柄组件12旋转。活动手柄构件24包括挠性手柄部分508、击发释放部分504以及击发开关506。
在一种实施方式中，外科设备10还包括关节连接机构(未示出)，其具有与凸轮构件可操作地接合的关节连接杆30，该凸轮构件具有阶梯式凸轮通道。该关节连接机构被支撑在转动构件28上并包括绕枢轴构件140可枢转地安装的关节连接杆30，该枢轴构件140从转动构件28向外延伸并优选地与之一体形成。凸轮构件与移动构件接合，该移动构件包括尺寸大小设计为容纳在阶梯式凸轮通道内的销，使得杆的枢转运动引起移动构件的线性运动。第一关节连接连接件包括适合于接合移动构件的近端和适合于接合定位在一次性装载单元中的第二关节连接连接件的远端。移动构件的线性运动引起关节连接连接件的线性运动，以使DLU 16的工具组件17关节连接。在给出的实施方式中，关节连接杆30还优选地安装在筒形部分26的前端上并且邻近转动构件28以利于工具组件17关节连接。
手柄组件12包括形成手柄组件12的固定手柄构件22以及筒形部分26的外壳36，其优选地由模制的半节外壳36a和36b形成。活动手柄构件24绕枢轴销38可枢转地支撑于半节外壳36a和36b之间。偏压件(未示出)，优选地为扭转弹簧，偏压活动手柄24远离固定手柄22。致动轴46(图3)被支撑在外壳36的筒形部分26内并包括齿条48。具有齿条接合指状部43的驱动棘爪42绕枢轴销44可枢转地安装在活动手柄24的一端。偏压件(未示出)，也优选地为扭转弹簧，被放置以促使驱动棘爪42的接合指状部43朝向致动轴46的齿条48。活动手柄24是可枢转的，使驱动棘爪42的接合指状部43运动到与致动轴46的齿条48接触以使致动轴向远侧方向线性行进。致动轴46的前端可旋转地接收控制杆52的近端，使得致动轴46的线性行进引起控制杆52相应地线性行进。
在一种实施方式中，活动手柄构件24可连接到载荷传感器539。载荷传感器539连接到显示装置500和计算机538(例如处理器)。载荷传感器539测量沿外科设备10施加的载荷，其能够被计算机538读取并显示在显示装置500上。载荷传感器539能够感测施加到外科设备10的不同部分的力和/或扭矩。在给出的实施方式中，载荷传感器539可操作地连接到枢轴销38以感测由活动手柄构件24施加的扭矩。载荷传感器539还可连接到枢轴销44(未示出)以感测由外科设备10施加的力或扭矩。
包括一对牵引器旋钮32的回缩机构58(见图1)通过连接杆60连接到致动轴46的近端。连接杆60包括用于接收牵引器旋钮32的左右接合部分(未示出)以及中间部分(未示出)。牵引器旋钮32沿筒形部分26可动地放置以使致动轴46返回到回缩位置，在下面将作详细描述。
回缩机构58的尺寸和结构被设计成使其能够在形成于筒形部分26的每一侧上的一对纵向槽34中移动。释放板64与致动轴46可操作地相关联并被安装用于响应牵引器旋钮32的操作相对于致动轴46运动。一对间隔开的销66从致动轴46的侧面向外延伸到与一对形成于释放板64中的对应的倾斜凸轮槽68相接合。在牵引器旋钮32向后运动时，销66能够相对于致动轴46并且相对于齿条48向下释放板64，使得释放板64的底部部分延伸到齿条48下面以使驱动棘爪42的接合指状部43从齿条48脱离。横向槽70形成于释放板64的近端处以容纳连接杆60的中间部分，细长槽34被限定在手柄组件12的筒形部分26中以在牵引器旋钮32被向后拉动以回缩致动轴46并由此向后回缩控制杆52时容纳连接杆60的纵向移动。致动轴46通过弹簧(未示出)向近侧偏压。
在一种实施方式中，外科设备10优选地包括显示装置500。显示装置500向用户提供关于刀具的位置、钉仓组件18的击发状态以及钉仓组件18中包含的缝钉的类型的反馈。该反馈可以是显示在显示装置上的数字、文字数字、或图形元素的形式。例如，为了提供刀具位置的视觉反馈，可以显示与刀具的纵向位移相互关联的纵向。显示装置500还可以提供关于DLU 16的状态以及外科设备10的闭锁状态的反馈。在所示的实施方式中，显示装置500位于筒形部分26的任一侧上。开启/关闭开关502位于筒形部分26上以电启动和关闭外科设备10的电子元器件部分。开启/关闭开关502将电池530与外科设备10的各种电子元器件包括例如显示装置500、螺线管512以及松放开关528连接。
在一种实施方式中，外科设备10优选地包括能量启动的击发闭锁系统510。能量启动的击发闭锁系统510在非通电状态下被激活以在系统能量衰竭的情况下提供闭锁操作。能量启动的击发闭锁系统510防止外科设备10在下列各种情况下操作：例如存在空的(例如用尽的)钉仓的情况；没有钉仓的情况；在回缩刀具之后存在部分用尽的钉仓的情况；在松开外科缝合设备之后存在部分用尽的钉仓的情况；以及在外科缝合设备完全循环操作之后存在部分用尽的钉仓的情况。
图3示出了细长主体14与手柄组件12相互连接。外壳36包括环形通道117，其能够容纳形成在转动构件28的近端上的环形肋118，外壳36优选地由模制的半节形成。环形通道117和肋118允许转动构件28和外壳36之间的相对转动。因此，旋钮28相对于手柄组件12的转动导致细长主体14相对于手柄组件12相应地转动。
参照图3和4，能量启动的击发闭锁系统510包括螺线管512和可枢转的锁定构件514。螺线管512由电池530供电。可枢转的锁定构件514可绕枢轴销516枢转并包括能够在槽口522内锁定的锁定表面518。偏压构件520，优选地为压缩螺旋弹簧，偏压可枢转的锁定构件514在锁定位置(如图所示)。锁定表面518通过紧固件526固定地连接到可枢转的锁定构件514。在断电状态下(如实线所示)，螺线管512的柱塞524部分充分地回缩以允许锁定表面518缩回到槽口522中以防止致动轴46水平移动。当通过给螺线管512通电致动柱塞524时，柱塞524驱动可枢转的锁定构件514向下到非锁定位置(如虚线所示)以使可枢转的锁定构件514沿向下的方向枢转(也如虚线所示)并从槽口522释放锁定表面518以使致动轴46能够水平移动。
击发闭锁系统510必须被解锁以使致动轴46向远侧行进。为了解锁击发闭锁系统510，活动手柄24的击发释放部分504沿箭头“B”表示的方向运动到与击发开关506接合以致动螺线管512。当螺线管512被致动时，其沿向下的方向驱动柱塞524以从槽口522释放锁定表面518。一旦锁定表面518被从槽口522中释放，致动轴46可通过沿箭头“A”表示的方向绕枢轴销38枢转活动手柄24而向远侧行进。每次冲程使致动轴46行进预定的距离(例如大约15mm)。随着活动手柄24的每次枢转冲程，驱动棘爪42的齿条接合指状部43向远侧驱动齿条48以及致动轴48预定的距离。通过重复地绕枢轴销38枢转活动手柄24允许致动轴46进一步向远侧行进。如上所述，通过向近侧拉动牵引器旋钮34，致动轴46可返回到近侧回缩位置。一直向近侧拉动牵引器旋钮34使致动轴46的近侧部分能够接触并致动松放开关528以松开钉砧组件20。
使用位置传感器来确定致动轴46的纵向位置。在一种实施方式中，位置传感器包括编码器532和感应线圈534。编码器532固定连接到致动轴46上并随其沿纵向运动。编码器532提供对应于致动轴46的纵向位置的电信号(例如模拟的或数字的)，并因此控制杆52。感应线圈534固定安装在外壳36的内部部分。感应线圈534穿过形成于编码器532中的孔定位。下面参照图5描述位置传感器的操作。
图5示出了能量启动的电反馈和击发闭锁系统550的一种实施方式。能量启动的电反馈和击发闭锁系统550通过电池530运转，该电池530用作开关506、528、位置传感器532、感应线圈534、重载识别装置536、计算机538以及显示装置500的电源。使用开启/关闭开关502从电池530施加功率到各种电子元器件并切断向各种电子元器件提供功率。在操作中，计算机538监控击发开关506、松放开关528的状态以及活动手柄构件24的致动顺序。
如前所述，编码器532和致动轴46沿纵向移动，感应线圈534保持不动。可以校准电信号以使其对应于致动轴46从最小的第一位移位置(完全回缩)到最大的第二位移位置(充分延伸)的位置。在一种实施方式中，编码器532可以是线性编码器，该线性编码器是与编码致动轴46的位置的刻度配对的传感器、转换器或读出磁头。传感器读出该刻度以便将编码的位置转换为模拟或数字信号，然后其能够被数字读出系统(DRO)解码为位置。线性编码器技术包括电容式的、感应的、涡流的、磁的和光学的。光学技术包括阴影、自成像以及干涉。编码器532的解码输出提供给显示装置500，显示装置可包括液晶显示器(LCD)或类似的显示元件。编码器532的解码输出可表示致动轴46的纵向位置。显示装置500显示编码器532的编码输出以向用户提供关于致动轴46和/或控制杆52沿其纵向长度从最小位移(完全回缩)到最大位移(充分延伸)的位置的反馈。例如，当一次性装载单元具有长度大约为30mm的线性缝钉排时，外科设备10的位移可以是大约0-30mm，而当一次性装载单元具有长度大约为60mm的线性缝钉排时，外科设备10的位移可以是大约0-60mm。显示装置500的示值读数可以是适合于表示致动轴46沿着冲程长度(例如，大约0-30mm或大约0-60mm)从最小位移(完全回缩)到最大位移(充分延伸)的位置的数字、文字数字、图形或累积条。
操作顺序
现参照图1-5，当前对操作顺序的描述将不在此讨论切割和外科设备10的各种部件以及它们的操作，除非是描述能量启动的击发闭锁系统510的操作所必需的。为了使用外科设备10，首先将诸如DLU16的一次性装载单元固定到细长主体14的远端。如上所述，外科设备10可以与关节连接或非关节连接的一次性装载单元一起使用，该一次性装载单元具有各种高度(例如，0.75mm、1mm、1.5mm或2mm)和形状(例如，弯的/弧形的、直的)且在大约30mm和大约60mm之间的线性缝钉排。为了将DLU 16固定到细长主体14，控制杆52的远端插入到DLU 16的插入末端(未示出)中，且该插入末端沿纵向滑入到细长主体14的远端中。
来自电池530的电能通过将开启/关闭开关502转到“开启”位置施加到外科设备10上。在从电池530施加电能之后，重载识别装置536感测钉仓组件18的存在。计算机538从指示钉仓组件18的各种状态的重载识别装置536读取钉仓组件18的状态。计算机538基于由重载识别装置536提供的钉仓组件18的状态使击发闭锁系统510能够或不能进行操作。如果钉仓组件18存在且满载有缝钉，那么计算机538使外科设备10能够进行正常操作。因此，可通过致动击发开关506并给螺线管512通电来解锁电子闭锁系统510。计算机538阻止给螺线管512通电并保持电子闭锁系统510在锁定状态，禁止使用外科设备10的操作即使击发开关506在下列情形下被致动：如果钉仓组件18不存在；如果钉仓组件18存在，但被用尽(例如，没有缝钉)；如果在刀具回缩之后存在部分用尽的钉仓组件18；如果在松开外科设备10之后存在部分用尽的钉仓组件18；以及如果在外科设备10的完全循环操作之后存在部分用尽的钉仓组件18。
在DLU16连接到缝合设备10上时，工具组件17通过打开的第一钉砧组件20围绕组织定位并在钉砧组件20和钉仓组件18之间接收并夹紧组织。通过使用牵引器旋钮32回缩致动轴46来致动松放开关528从而能够将钉砧组件20打开。钉砧组件20能够通过致动击发开关506关闭。这可以通过沿箭头“A”表示的方向运动活动手柄构件24一个冲程并致动击发开关506来实现。在箭头“A”表示的方向上运动活动手柄构件24一个冲程使驱动棘爪42运动并使致动轴46和控制杆52向远侧行进。要注意到的是，活动手柄24的一个完整的冲程使致动轴46行进大约15mm，其足够在活动手柄24的第一冲程期间夹紧组织而不足以击发缝钉。
在活动手柄24的第一(夹紧)冲程期间，滑动板102阻止锁定棘爪54与齿条48接合。在活动手柄24释放时，当手柄24通过扭转弹簧(未示出)返回到与固定手柄22间隔的位置时，驱动棘爪42在齿条48之上运动。在这个位置，驱使驱动棘爪42与齿条48接合以保持致动轴46在其纵向固定位置。
为在第二和随后的冲程期间击发缝钉，重复地致动活动手柄24，即在连续的冲程中运动。如上所述，外科设备10能够容纳具有多个线性缝钉排的DLU 16。因为活动手柄24的每个冲程优选地使致动轴46行进大约15mm，且需要一个冲程来夹紧组织，活动手柄24必须致动(n+1)个冲程来击发缝钉，其中n是连接到切割和外科设备10的一次性装载单元中的线性缝钉排的长度除以大约15mm。例如，对于15mm的钉仓，n＝1；对于45mm的钉仓，n＝3；对于60mm的钉仓，n＝4。
在能够击发缝钉之前，必须致动击发闭锁系统510以使锁定表面518从阻挡位置运动到非阻挡位置。这通过沿箭头“B”表示的方向挤压活动手柄24的击发释放部分504到与击发开关506接合以给螺线管512通电来实现。当螺线管512通电时，柱塞524向下驱动可枢转的锁定构件514以从槽口522中释放锁定表面518并由此使致动轴46能够水平移动。此后，活动手柄24可被致动适当数量的冲程以使致动轴46并由此使控制杆52沿箭头“C”表示的方向向远侧行进，从而使致动滑架(未示出)通过钉仓组件18的整个长度行进以执行缝钉的发射。
为了将外科设备10的DLU 16和细长主体14穿过套管针的狭窄的套管插入，钉砧组件20最初必须是关闭的。通过接合击发释放部分504并致动击发开关506一次来关闭钉砧组件20以解锁电子闭锁系统510(例如，给螺线管512通电)。在电子闭锁系统510处于解锁状态时，挠性手柄24能够沿箭头“A”表示的方向运动一个冲程以使致动轴46向远侧行进以关闭钉砧组件20。一旦挠性手柄24被释放，电子闭锁系统510被再次锁定。在钉砧组件20关闭时，外科设备10的DLU 16和细长主体14能够穿过套管针的狭窄的套管插入以将工具组件定位在手术部位。钉砧组件20必须打开以便在钉砧组件20和钉仓组件18之间夹紧组织。钉砧组件20可通过利用牵引器旋钮32向近侧回缩致动轴46直到松放开关528被致动而打开。当致动轴46接合松放开关528时，计算机538感测松放开关528的接触关闭并给螺线管512通电以解锁电子闭锁系统510。活动手柄构件24现在能够沿箭头“A”表示的方向运动一个冲程以使致动轴46向远侧行进以关闭钉砧组件20并在钉砧组件20和钉仓组件18之间夹紧组织。为了击发钉仓组件18，用户接合击发释放部分504并致动击发开关506以解锁电子闭锁系统510并且通过重复地致动挠性手柄24适当数量的冲程直到整个钉仓组件18被用尽来使致动轴46能够向远侧行进。一旦钉仓组件18被用尽，对重载识别装置536中的一次性可编程存储寄存器进行编程以指示钉仓组件被用尽。从而，由于重载识别装置536指示钉仓组件18被用尽，因此通过计算机538外科设备10被进一步地击发。
为了在击发冲程要结束时，例如在击发缝钉之后回缩致动轴46并由此回缩控制杆52，向近侧拉动牵引器旋钮32使销66沿箭头“D”表示的方向在齿条48上运动释放板64以使驱动棘爪42从与齿条48接合到脱离。当完全回缩时，致动轴46致动松放开关528以打开钉砧组件20。工具组件17现在能够从手术部位移开。活动手柄构件24沿箭头“A”表示的方向致动一个冲程以关闭钉砧组件20，使得工具组件17、细长主体14和DLU 16可通过套管针的狭窄的套管回缩。
根据本发明的装置可设计成在一次使用后丢弃，或者可设计成多次使用。然而，在任何一种情况下，装置能够被修复以备在使用至少一次之后再次使用。修复可包括装置的拆卸、接着清洗或更换特定部件和随后的重新组装这些步骤的任意组合。特别地，该装置可以被拆卸，任何数量的特定部件或零件可以有选择地以任意组合被更换或去除。在清洗和/或替换特定部件之后，装置可在修复设备中或在即将进行手术程序之前由手术队进行重新组装以便以后使用。本领域技术人员将会理解对该装置的修复可利用用于拆卸、清洗/替换、和重新组装的各种技术。这些技术的使用以及产生的修复好的装置也全都在本申请的保护范围内。
优选地，在本文中公开的本发明的各种实施方式将在外科手术前被处理。首先，获取新的或者使用过的器械并在需要的情况下对其进行清洁。该装置然后进行灭菌。装置可以使用现有技术中已知的任何其他工艺进行灭菌，包括但不限于β或γ射线、环氧乙烷和蒸汽。在一种灭菌工艺中，器械被放置在闭合且密封的容器中，诸如塑料袋或高密度聚乙烯合成纸袋(TYVEK bag)。容器和器械然后被放置在可穿透容器的辐射场中，诸如γ射线、x射线或者高能电子。辐射杀死器械上以及容器中的细菌。灭菌后的器械然后可被储存在无菌容器中。密封的容器保持器械处于无菌状态，直到其在医学场合下被打开。
应当认识到可以就在此公开的实施方式作各种修改。例如，缝合设备不必施加缝钉而可以施加本领域熟知的两部分紧固件。此外，可以修改线性缝钉排或紧固件排的长度以满足特定外科手术的需要。因此，致动轴的单个冲程的长度和/或一次性装载单元中的线性缝钉排和/或紧固件排的长度可以相应地改变。所以，上面的描述不应该解释为限制性的，而仅仅作为优选实施方式的范例。本领域的技术人员可以设想在所附权利要求书的范围和精神内的其它修改。
Claims (9)
1.一种外科设备(10)，包括：
手柄组件(12)，其包括活动手柄(24)，该活动手柄(24)在致动冲程中可动；
细长主体(14)，其从所述手柄组件(12)向远侧延伸并限定纵向轴线，该细长主体(14)具有能够可释放地接合关节连接和非关节连接的一次性装载单元(16)类型的远端；
致动轴(46)，其至少部分地支撑在所述手柄组件(12)中且其安装是为了响应所述活动手柄(24)的操纵而沿纵向运动；
直流电源(530)；以及
能量启动的击发闭锁系统(510)，其阻止所述外科设备(10)在多种情况下的操作；其特征在于，
所述能量启动的击发闭锁系统(510)包括可操作地连接到可枢转的锁定构件(514)的螺线管(512)，以防止所述致动轴(46)的纵向运动，且其中所述螺线管(512)由所述直流电源(530)供电。
2.根据权利要求1所述的外科设备(10)，包括传感装置(537)。
3.根据权利要求2所述的外科设备(10)，其中，该传感装置(537)包括载荷传感器(537)。
4.根据权利要求3所述的外科设备(10)，其中，该载荷传感器(537)连接到所述活动手柄(24)上。
5.根据权利要求2所述的外科设备(10)，其中，该传感装置(537)包括连接到所述致动轴(46)上的位置传感器。
6.根据权利要求5所述的外科设备(10)，其中，所述位置传感器包括编码器(532)和感应线圈(534)，其中，该编码器(532)固定地连接到所述致动轴(46)上并随其沿纵向运动。
7.根据权利要求6所述的外科设备(10)，其中，该编码器(532)提供指示所述致动轴(46)的纵向位置的输出。
8.根据权利要求1所述的外科设备(10)，包括：
一次性装载单元(16)；以及
位于该一次性装载单元(16)中的钉仓组件(18)。
9.根据权利要求8所述的外科设备，包括定位在所述一次性装载单元(16)中的重载识别装置(536)，该重载识别装置(536)包括存储涉及该钉仓组件(18)的状态信息的存储器。
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2009
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- 2009-02-13 EP EP09250368.9A patent/EP2090241B1/en not_active Not-in-force
- 2009-02-13 RU RU2009105139/14A patent/RU2492822C2/ru not_active IP Right Cessation
- 2009-02-16 CN CN2009101307603A patent/CN101518460B/zh not_active Expired - Fee Related
- 2009-02-16 BR BRPI0901480A patent/BRPI0901480B8/pt not_active IP Right Cessation
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Also Published As
| Publication number | Publication date |
|---|---|
| BRPI0901480B1 (pt) | 2019-07-02 |
| EP2090241A1 (en) | 2009-08-19 |
| CN101518460A (zh) | 2009-09-02 |
| JP2009189841A (ja) | 2009-08-27 |
| US8608044B2 (en) | 2013-12-17 |
| US20090206132A1 (en) | 2009-08-20 |
| BRPI0901480B8 (pt) | 2021-06-22 |
| RU2492822C2 (ru) | 2013-09-20 |
| RU2009105139A (ru) | 2010-08-20 |
| BRPI0901480A2 (pt) | 2010-04-06 |
| JP5484749B2 (ja) | 2014-05-07 |
| EP2090241B1 (en) | 2018-10-10 |
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