CN101675894A - 具有指示器械已切穿组织的装置的外科缝合器械 - Google Patents

具有指示器械已切穿组织的装置的外科缝合器械 Download PDF

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CN101675894A
CN101675894A CN200910171920A CN200910171920A CN101675894A CN 101675894 A CN101675894 A CN 101675894A CN 200910171920 A CN200910171920 A CN 200910171920A CN 200910171920 A CN200910171920 A CN 200910171920A CN 101675894 A CN101675894 A CN 101675894A
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R·F·施韦姆伯格
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Ethicon Endo Surgery Inc
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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
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation
    • A61B17/1155—Circular staplers comprising a plurality of staples
    • 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
    • A61B2017/00115—Electrical control of surgical instruments with audible or visual output
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
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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
    • 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
    • A61B2017/07285—Stapler heads characterised by its cutter
    • 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
    • A61B90/08—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

Abstract

本发明涉及一种具有指示器械已切穿组织的装置的外科缝合器械，更具体地说公开了一种用于切割组织并且在组织上施加一个或多个外科缝钉的圆形缝合器械。该器械包括各种形式的反馈系统，该反馈系统设计为当刀已经切穿被夹在钉仓和钉砧之间的组织时向医生提供至少一种方式的反馈。

Description

具有指示器械已切穿组织的装置的外科缝合器械
技术领域
本发明整体涉及外科缝合器，更特别地涉及用于执行吻合缝合手术的圆形缝合器械。
背景技术
在一些类型的外科操作中，外科缝钉的使用已经成为组织接合的优选方法，这样，为这些应用开发了特别配置的外科缝合器。例如，为了在被称为吻合术的外科操作中使用而开发了腔内缝合器或圆形缝合器。用于执行吻合术的圆形缝合器在例如美国专利No.5,104,025、No.5,205,459、No.5,285,945和No.5,309,927中被公开，上述专利均通过引用整体包含于此。
吻合术的一种形式包括在肠的连接段被切除后将肠的剩余段接合起来的外科操作。该操作要求将两个管状段的末端接合到一起以形成连续的管状通道。以前，这种外科操作是费力而又耗时的手术。医生需要精确地切割，且将肠的末端对准，并且在用缝线缝许多针将末端接合的同时保持肠末端的对准。圆形缝合器的开发大大地简化了吻合术操作并且也减少了执行吻合术所需要的时间。
一般来说，传统圆形缝合器典型地包括细长轴，所述细长轴具有安装在轴上的近侧致动机构和远侧缝合机构。远侧缝合机构典型地包括固定的钉仓，所述钉仓内容纳多个以同心圆阵列配置的缝钉。圆形切割刀同中心地安装在钉仓内并位于缝钉内侧。所述刀可沿着轴向远侧方向运动。套管针轴从钉仓的中央轴向地延伸，所述套管针轴具有与其以可去除的方式联接的钉砧。所述套管针轴可相对于钉仓和细长轴轴向运动。所述钉砧被配置为当缝钉被驱动至钉砧时使得缝钉的末端成型。钉仓的远侧面与钉砧之间的距离通过安装在缝合器轴的近端的调节机构来控制。当医生使致动机构致动时，容纳在钉仓和钉砧之间的组织同时被缝合及切割。
当使用圆形缝合器执行吻合术时，典型地使用在肠的目标段(即样本)的两侧均置有两排缝钉的传统外科缝合器来缝合肠。当目标段被缝合时，该段同时被切割。在去除样本之后，医生典型地将钉砧插入腔的近端、位于钉线的近侧。这是通过将钉砧头插入医生在近侧腔中切割的入口而完成的。有时，可以由肛门放置钉砧，通过将钉砧头放置在缝合器的远端上并且将器械穿过直肠插入。然后医生用缝线或其他传统的系紧工具将肠的近端系紧在钉砧轴上。接着，医生切割邻近系紧部分的多余的组织并且将钉砧与缝合器的套管针轴连接。然后，医生闭合钉砧与钉仓之间的空隙，从而在空隙处将肠的近端和远端接合。然后医生使缝合器致动，导致若干排缝钉被驱动穿过肠的两端并且成型，从而接合两端并且形成管状通道。当缝钉被驱动并成型的同时，同中心的圆形刀的刀刃被驱动穿过肠组织末端，切割邻近内排缝钉处的末端。然后医生将缝合器从肠中退出并且完成吻合。
但是，在缝合过程中，对于医生来说通常很难准确地确定刀刃什么时候已经完全切穿组织。在致力于为医生提供关于刀的行程的一些形式的反馈时，一些现有缝合器配备有塑料垫圈或刀板，其被设计为当刀刃穿过组织接触并穿透垫圈时提供“嘎吱”的声音。但是这种反馈往往并不足够。
因此需要一种具有用于提供圆形刀已完全切穿组织的指示的改进的系统的圆形外科缝合器。
发明内容
本发明通过提供一种用于在组织上施加一个或多个外科缝钉的外科缝合器械，克服了现有技术的上述缺点和其他缺点。该外科器械的一种形式包括手柄组件和缝合头组件，所述缝合头组件通过轴组件可操作地联接到所述手柄组件。在各种实施方式中，该器械可以包括钉仓和钉砧，所述钉仓用于支撑一个或多个外科缝钉，所述钉砧用于抵靠着钉仓夹住组织。可以提供缝钉驱动组件来接合并驱动缝钉，使缝钉从钉仓进入组织并抵靠钉砧。刀可动地支撑在缝合头组件内，用于切穿被夹住的组织。提供驱动系统用于选择性地向缝钉驱动组件和刀施加驱动动作。该器械还包括具有至少一个传感器的反馈系统，所述传感器被配置为当刀切穿被夹住的组织时向指示器发出信号。
在本发明的另一总的方面，提供用于在组织上施加一个或多个外科缝钉的外科缝合器械。在各种实施方式中，该器械包括手柄组件和缝合头组件，所述缝合头组件通过轴组件可操作地联接到所述手柄组件。所述缝合头组件可以包括钉仓和钉砧，所述钉仓用于支撑一个或多个外科缝钉，所述钉砧用于抵靠着钉仓夹住组织。提供缝钉驱动器来接合并驱动缝钉，使缝钉从钉仓进入组织并抵靠钉砧。刀可动地支撑在缝合头组件内，用于切穿被夹住的组织。提供驱动系统用于向缝钉驱动器和刀施加驱动动作。也提供反馈系统。在各种实施方式中，反馈系统可以包括安装在钉砧内的刀板。所述刀板可以具有可操作地支撑在刀板内的至少一个传感器，所述传感器用于在刀切穿被夹住的组织后检测刀的存在。所述传感器可操作地与由手柄组件支撑的指示器通信，使得当刀已经切穿被夹住的组织时传感器允许指示器被供电。
根据本发明的另一总的形式，提供用于在组织上施加一个或多个外科缝钉的外科缝合器械。在各种实施方式中，该外科器械包括手柄组件和缝合头组件。所述缝合头组件可以包括钉仓和缝钉驱动器，所述钉仓用于在其中可操作地支撑多个缝钉，所述缝钉驱动器用于从钉仓接合并驱动缝钉。刀可动地支撑在缝合头组件内。也提供驱动系统用于向缝钉驱动器和刀施加驱动动作。轴组件可以可操作地联接到手柄组件和缝合头组件。所述轴组件可以包括可选择地运动的套管针。钉砧可以可拆卸地安装在套管针上并且被相对于缝合头组件定位为使得至少一些组织可以被夹在钉仓和钉砧之间。该外科器械还可以包括反馈系统，所述反馈系统包括至少一个传感器，所述传感器由钉砧支撑并且可操作地与由手柄组件支撑的指示器通信，使得当刀已经切穿被夹住的组织时传感器允许指示器被供电。
更具体地说，本发明涉及如下内容：
(1).一种用于在组织上施加一个或多个外科缝钉的外科缝合器械，包括：
手柄组件；
缝合头组件，其通过轴组件与所述手柄组件可操作地联接，所述缝合头组件包括：
钉仓，其用于支撑一个或多个外科缝钉；
钉砧，其用于抵靠着所述钉仓夹住所述组织；
缝钉驱动组件，其用于接合并驱动所述缝钉，使所述缝钉从所述钉仓进入组织并抵靠所述钉砧；以及
刀，其可动地支撑在所述缝合头组件内，用于切穿被夹住的组织；
驱动系统，其用于将驱动动作施加到所述缝钉驱动组件和所述刀上；以及
反馈系统，其包括至少一个传感器，所述传感器被配置为当所述刀已切穿被夹住的组织时向指示器发送信号。
(2).如第(1)项所述的外科缝合器械，其中，所述反馈系统包括支撑在所述钉砧内的刀板，且其中所述至少一个传感器由所述刀板支撑。
(3).如第(2)项所述的外科缝合器械，其中，所述至少一个传感器包括附着于所述刀板的至少一根导线。
(4).如第(3)项所述的外科缝合器械，其中，所述至少一根导线嵌入所述刀板中。
(5).如第(2)项所述的外科缝合器械，其中，所述至少一个传感器包括磁传感器。
(6).如第(1)项所述的外科缝合器械，其中，所述指示器包括从指示器组中选择的一种指示器，所述指示器组包括：发光装置、振动产生装置以及发声装置。
(7).如第(1)项所述的外科缝合器械，其中，所述反馈系统被配置为当所述刀已切穿所述被夹住的组织时提供至少一种其他形式的反馈。
(8).如第(7)项所述的外科缝合器械，其中，所述至少一种其他形式的反馈包括能够通过握住所述手柄组件感觉到的触觉反馈。
(9).如第(7)项所述的外科缝合器械，其中，所述至少一种其他形式的反馈包括声音反馈。
(10).如第(2)项所述的外科缝合器械，其中，所述刀板包括壁部分，所述壁部分被配置为在所述刀切穿所述被夹住的组织后受到所述刀切割，使得通过所述刀切穿所述刀板能够产生至少声音信号或触觉信号。
(11).一种处理外科器械的方法，所述方法包括：
获取如第(1)项所述的外科缝合器械；
给所述外科缝合器械除菌；以及
将所述外科缝合器械储存在无菌容器中。
(12).一种用于在组织上施加一个或多个外科缝钉的外科缝合器械，包括：
手柄组件；
缝合头组件，其通过轴组件与所述手柄组件可操作地联接，所述缝合头组件包括：
钉仓，其用于支撑一个或多个外科缝钉；
钉砧，其用于抵靠着所述钉仓夹住所述组织；
缝钉驱动器，其用于接合并驱动所述缝钉，使所述缝钉从所述钉仓进入组织并抵靠所述钉砧；以及
刀，其可动地支撑在所述缝合头组件内，用于切穿被夹住的组织；
驱动系统，其用于将驱动动作施加到所述缝钉驱动器和所述刀上；以及
反馈系统，其包括安装在所述钉砧内的刀板，所述刀板具有可操作地支撑在该刀板内的至少一个传感器，所述传感器用于当所述刀切穿所述被夹住的组织后检测所述刀的存在，所述传感器可操作地与由所述手柄组件支撑的指示器通信，使得当所述刀已切穿所述被夹住的组织时，所述传感器允许所述指示器被供电。
(13).如第(12)项所述的外科缝合器械，其中，所述传感器包括位于所述刀板上的至少一根导线，并且其中至少一个指示器包括安装在所述手柄组件上的至少一个发光二极管。
(14).一种用于在组织上施加一个或多个外科缝钉的外科缝合器械，包括：
手柄组件；
缝合头组件，其包括：
钉仓，其用于在其中可操作地支撑多个缝钉；
缝钉驱动器，其用于从所述钉仓接合并驱动所述缝钉；
刀，其可动地支撑在所述缝合头组件内；
驱动系统，其用于将驱动动作施加到所述缝钉驱动器和所述刀上；
轴组件，其与所述手柄组件和所述缝合头组件可操作地联接，所述轴组件包括可选择地运动的套管针；
钉砧，其可拆卸地安装在所述套管针上并且相对于所述缝合头组件被定位，使得至少一部分所述组织能够被夹在所述钉仓和所述钉砧之间；以及
反馈系统，其包括至少一个传感器，所述至少一个传感器由所述钉砧支撑并且可操作地与由所述手柄组件支撑的指示器通信，使得当所述刀已切穿被夹住的组织时，所述至少一个传感器允许所述指示器被供电。
(15).如第(14)项所述的外科缝合器械，其中，所述钉砧包括主体部分和从所述主体部分伸出的杆部，所述杆部被配置为在所述杆部内可操作地接收所述套管针的尖部。
(16).如第(15)项所述的外科缝合器械，其中，所述指示器被支撑在所述手柄组件上，并且其中所述钉砧杆部被配置为当所述套管针的所述尖部位于所述钉砧杆部内时在所述至少一个传感器和至少一个指示器之间建立电连接。
(17).如第(15)项所述的外科缝合器械，还包括支撑在所述钉砧的所述主体部分内的刀板，所述刀板内部可操作地支撑所述至少一个传感器。
(18).如第(17)项所述的外科缝合器械，其中，所述刀板被配置为当所述刀推进穿过所述刀板的一部分时除所述信号外产生可听到的声音。
(19).如第(14)项所述的外科缝合器械，其中，所述指示器包括从指示器组中选择的一种指示器，所述指示器组包括：发光装置、振动产生装置以及发声装置。
(20).如第(14)项所述的外科缝合器械，其中，所述反馈系统被配置为当所述刀已切穿所述被夹住的组织时提供至少一种其他形式的反馈。
附图说明
结合入说明书且构成说明书的一部分的附图描述了本发明的实施方式，并且与上述本发明的总体描述以及下述具体实施方式的详细说明一起用于解释本发明的原理。
图1为可以与本发明的各种实施方式一起使用的外科缝合器的透视图；
图2为如图1所示外科缝合器的缝合头组件的分解组合视图；
图3为如图1所示外科缝合器的轴与缝合头组件的剖视图；
图4为本发明的钉砧与刀板的实施方式的透视图；
图5为本发明的行程指示器电路的实施方式的示意图；
图6为如图1-4所示的缝合器在肠的一段被切除后插入肠中处于打开位置的部分剖视图；
图7为如图6所示的缝合器在肠的近端与远端被缝合在钉砧轴周围时的部分剖视图；
图8为如图6、7所示的缝合器在钉砧相对于缝合头组件被牵引至预击发位置时的部分剖视图；
图9为如图6-8所示的缝合器在已被击发后的另一部分剖视图；
图10为本发明的另一种钉砧与刀板的实施方式的透视图；
图11为本发明的另一种外科缝合器的实施方式的缝合头组件的分解组合视图；
图12为本发明的另一种行程指示器电路的实施方式的示意图；
图13为如图10-12所示的缝合器插入一段被切除的肠中处于打开位置的部分剖视图；
图14为如图13所示的缝合器在肠的近端与远端被缝合在钉砧轴周围时的另一部分剖视图；
图15为如图13、14所示的缝合器在钉砧被牵引至预击发位置时的又一部分剖视图；以及
图16为如图13-15所示的缝合器在已被击发后的另一部分剖视图。
具体实施方式
如附图，其中同样的附图标记表示同样的部件，示出了圆形缝合器10，所述圆形缝合器包括一种独特且新颖的系统，用于向医生提供反馈，以指示器械什么时候已切穿夹在器械中的组织。在本领域中已知各种不同的圆形缝合器。图1-5示出了可以利用本发明各方面优点的一种示例性的圆形缝合器的布置。但是可以想到，在不脱离本发明的精神和范围的条件下，本发明的各种实施方式可以成功地在其他缝合器构造上使用。
图1中可以看到，公开了一种圆形缝合器10，所述圆形缝合器10包括缝合头组件12、钉砧100、调节旋钮30以及扳机14。所述缝合头组件12通过轴组件50与手柄组件40联接。所述扳机14可枢转地支撑在手柄组件40上并且被配置为当安全机构16被释放时操作缝合器10。当扳机14被致动时，驱动系统在轴组件50的内部进行操作使得缝钉90(图2)被从缝合头组件12中排出与钉砧100进行成型接触。同时，可操作地支撑在缝合头组件12内的刀70进行动作以切割保持在被缝合组织的周界内的组织。然后将缝合器10从组织中拉动穿过，将被缝合的组织留在其位置上。
图2和图3示出了可以与本发明的多种实施方式联系使用的钉砧100和缝合头组件12的一种形式。从图中可以看到，钉砧100可以具有圆形的主体102，所述主体102具有钉砧轴104，用于连接套管针60(图3)。所述钉砧主体102上具有缝钉成型底面106，所述钉砧主体也可以具有与其远端连接的护罩108。所述钉砧100还可以设有一对套管针保持夹或板形弹簧110，用于可释放地将套管针60保持在与钉砧轴104的保持接合中，后文将更为详细地进行讨论。
图2中可以看到，缝合头组件12可以包括壳构件20，所述壳构件20的内部支撑有缝钉驱动组件22形式的钉仓支撑组件，所述钉仓支撑组件适于与圆形钉仓24接合并且驱动支撑在钉仓内的缝钉90使缝钉与钉砧100的缝钉成型底面106进入成型接触。所述圆形刀70设置在缝钉驱动组件22的中央并且所述圆形刀上形成有切割边缘72。壳构件20的近端21可以通过远侧套环构件52与轴组件50的外侧管状护罩51联接。
图3示出了可以在本发明的多种实施方式中使用的轴组件50的一种形式。所述轴组件50可以包括在外侧管状护罩51内组装的施压轴(compression shaft)54、远侧施压轴段55、上张力带56、下张力带58以及隔离带61。套管针尖62可以通过紧固件59与上张力带56以及下张力带58连接。上张力带56和下张力带58的近端可以与调节轴80的远端连接。如图3所示，套管针60的套管针尖62可以被插入钉砧100的钉砧轴104内并且通过所述套管针保持夹110保持接合。
图3中也可看到，远侧施压轴段55与缝钉驱动组件22联接。因此，施压轴54在外侧管状护罩51内的轴向运动导致缝钉驱动组件22在壳构件20内轴向运动。击发扳机14的致动将导致施压轴54沿远侧方向(箭头“DD”)运动，从而向远侧驱动缝钉驱动组件22，以击发缝钉90使其与钉砧100的缝钉成型底面106进入成型接触。随着缝钉驱动组件22被向远侧驱动，所述缝钉驱动组件22也驱动刀70的切割边缘72穿过保持在被缝合的组织周界内的组织并进入安装在钉砧100中的刀板210。
在各种实施方式中，调节轴80可轴向运动地支承在手柄组件40内，所述手柄组件的类型和构造在Todd Philip Omaits等人在2006年9月29日提交且公开号为No.US-2008-0078806A1的美国专利公布中公开，所述专利申请为本申请受让人所拥有并且其整体通过引用包含于此。但是，在不脱离本发明的精神和范围的条件下，其他手柄和击发系统设置也是可以使用的。
本发明的各种实施方式包括一种独特且新颖的反馈系统，所述反馈系统总体被标示为200，该反馈系统用于向医生提供切割部件已经切穿被夹在钉仓24和钉砧100之间的组织的指示。所述组织反馈系统200的一种实施方式如图3-5所示。例如，反馈系统200可以包括可以被装配入钉砧主体102的腔112内的刀板或垫圈210。所述刀板210提供所述圆形刀70可以进入的坚固的支持面。所述刀板210可以由塑料制成并且附有至少一个传感器220以检测什么时候刀210已经推进超过组织切割位置，从而保证组织已经被切割。在各种实施方式中，例如，传感器220可以包括定位在刀板210的近侧面212上的至少一根导线222。特别地，导线222可以通过粘合剂或其他合适的紧固件设置来附在刀板210的近侧面212上并且在近侧面212上被定向为，当刀70切穿定位在刀70的切割边缘和刀板210的近侧面212之间的组织之后与刀70“相互作用”。在其他实施方式中，所述至少一根导线222可以被嵌入刀板210内。
图5示出了可以与传感器220设置联系使用的反馈电路230。从图中可以看出，反馈电路230可以包括直流(DC)电源240，所述直流电源可以包括一个或多个电池242或其他合适的直流电源。所述电池242可以由手柄组件40支撑，使得所述电池可以很容易地安装和更换。反馈电路230可以另外包括第一电阻244，所述第一电阻244与位于刀板210内或刀板210上的一根或多根导线222串联。此外，第二电阻246与指示器250串联。所述第二电阻246和指示器与导线222并联，使得当导线222没有被刀70切断时所述导线222将第二电阻246和指示器250短路。在该实施方式中，在切穿组织之前，电流流过位于刀板210内或刀板210上的导线222，且很少或没有电流流过指示器250，使得指示器不被开启。但是，当刀70切断导线222时，电流流过第二电阻246并且给指示器250供电。所述指示器250可以包括灯、发光二极管(LED)、振动产生装置、发声装置等或其组合。
导线222中的每一根都可以通过导线或其他方式与形成在钉砧轴104上的钉砧触点105电联接。见图3和图4。所述钉砧触点105被布置为当钉砧轴104与套管针60联接时，钉砧触点与形成或通过其他方式安装在套管针尖62上的相应的套管针触点64电接触。所述套管针触点64通过相应的导线107连接到电池242以及支撑在手柄组件40中的指示器250。因此，当钉砧100与套管针60联接时，形成了一个完整的电反馈电路230。
现在将参照图6-9描述使用圆形缝合器10的一种示例性的方法。当使用圆形缝合器10执行吻合时，可以使用在肠300的目标段(即样本)的两侧均置有多排缝钉的传统的外科缝合器来缝合肠300。图6示出了衬里(liner)钉线310、320。典型地，当目标段被缝合时，所述目标段被同时切割。图6中目标段已经被切除。在去除目标样本之后，医生将钉砧100插入肠300的近侧部分302中并位于钉线310的近侧。这是通过将钉砧100插入在肠近侧部分302上切割的入口来完成的，或者钉砧100可以由肛门放置，通过将钉砧100放置在缝合器10的远端上并且将器械插入通过直肠。然后医生将钉砧100与缝合器10的套管针尖62连接并且将钉砧100插入肠300的远侧部分306。然后医生可以用缝线312或其他传统系紧工具将肠300的近侧部分302的远端304系紧在钉砧轴104上，并且也用另一根缝线314将肠远侧部分306的近端308系紧在钉砧轴上，见图7。然后，医生开始沿顺时针方向转动闭合旋钮组件30，以将钉砧100向由缝钉驱动器22所支撑的钉仓24牵引以闭合钉砧100与钉仓24之间的空隙，从而将肠远侧部分306的近端308与肠近侧部分302的远端304在其之间的空隙“G”处接合，见图8。医生继续转动闭合旋钮组件30直至达到所需要的空隙G。在该位置下，医生然后可以将安全轭16枢转至不工作位置并且通过按下击发扳机14将缝合器10击发。按下击发扳机14导致施压轴54向远侧驱动缝钉驱动器22，以将缝钉90驱动穿过肠300的两端304、308，从而将部分302和306接合使之形成管状通道。在缝钉90被驱动和成型的同时，刀70被驱动穿过肠组织末端304和308，在邻近内排缝钉90处切割末端，见图9。
从图9中可以看出，随着刀70切穿组织，切割边缘72切断导线222，导致指示信号被发送至指示器250。也就是，电流被允许流到指示器250以使指示器被供电并且向医生提供组织已经被切除的指示。在一种替代实施方式中，刀板210中可以另外提供环形腔214。在刀70切穿被夹住的组织之后，刀的边缘72可以进一步推进穿过覆盖刀板210中的环形腔214的壁部分212。随着刀70推进穿过壁部分212，可以产生可听见的声音。此外，随着刀发出嘎吱声地穿过壁部分212，医生可以感觉到一些触觉上的振动。因此，这样的设置可以在指示器250提供的指示(如光、声音、振动等)之外实际上向医生提供当切割边缘72切割或穿透壁部分212时产生的附加的听觉和/或触觉信号。
图10-16示出了本发明的另一种反馈系统200’的实施方式。在该实施方式中，例如，传感器220可以包括位于刀板210中的至少一个磁传感器260，所述磁传感器260被定向为当刀70切割组织后检测刀70。图12示出了一种示例性的电路230’。从图中可以看出，晶体管262可以连接到电池242、指示器250和磁传感器260。直至刀70切穿组织后磁传感器260检测到刀的存在，电流不允许流向指示器250。但是，当刀70切穿组织后磁传感器260检测到刀的存在时，电流被允许流向指示器250。磁传感器260可以如前文所述地连接到钉砧触点105，使得当钉砧轴104与套管针60连接时，电路230’被建立。
图13-16示出了指示器系统200’的操作。如从图中可以看出，在刀70的切割边缘72切穿组织之后，所述切割边缘72可以切断壁部分212，所述壁部分212覆盖着形成于刀板210中的环形腔214。随着刀70切穿壁部分212，可以产生可听到的声音。磁传感器260可以被定位在刀板210的壁中以同样检测切割边缘72在腔214中的存在。因此，如上面所讨论的，当磁传感器260检测到刀70时，电流被允许流到指示器250。因此，这样的设置可以在指示器250提供的第二指示(如光、声音、振动等)之外实际上向医生提供当切割边缘72切割或穿透壁部分212时产生的听觉和/或触觉信号。
本发明的各种实施方式代表了对现有的仅仅提供当切割刀切割或穿过刀板的一部分时产生的声音反馈的圆形缝合器设置的巨大改进。本发明的各种实施方式可以使用多指示器250并且提供多种形式的反馈(声音、视觉、振动、触觉)。同样，在这里公开的传感器形式之外，也可以使用替代的传感器设置。例如，可以使用机械传感器来检测刀70的切割边缘。这样的传感器可以被安装在刀板或类似的构件内，使得在刀的边缘切穿被夹住的组织之后，所述刀的边缘与机械传感器的一部分物理接触以导致机械传感器允许电流流到指示器250。
虽然已经描述了本发明的若干实施方式，但是应当清楚本领域技术人员可以想到这些实施方式的各种修正、变型和适用以实现本发明的部分或全部优点。例如，根据各种实施方式，单个部件可以被替换为多个部件，且多个部件可以被替换为单个部件，以执行给定的功能。因此在不脱离由权利要求书所限定的本发明的范围和精神的条件下，本申请意图覆盖所有这样的修正、变型和适用。
这里公开的装置可以被设计为一次性使用或者可以被设计为多次使用。但是，在任何一种情况下，该装置可以在至少一次使用后被修缮以再次使用。所述修缮可以包括下述步骤的组合：装置的分解、接下来是特定部分的清洁或替换以及接下来的重新组装。特别地，该装置可以被分解，以及该装置的任意数量的特定的部分或零件可以被选择性地以任何组合被替换或去除。在清洁和/或替换特定零件后，该装置可以被重新组合以备下次使用，这可以在修缮设施中进行，也可以由外科手术组在外科操作之前立刻进行。本领域的普通技术人员将理解，装置的修缮可以使用各种不同的技术来分解、清洁/替换和重新组装。这些技术的使用、以及最终的被修缮的装置，都落在本发明的范围内。
优选地，这里描述的本发明可以在外科手术之前进行处理。首先，获取一个新的或用过的器械，并且必要的话进行清洁。然后可以将该器械除菌。在一种除菌技术中，该器械可以被放置在一个闭合并且密封的容器中，如塑料或高密度聚乙烯合成纸
Figure G2009101719209D00141
袋中。然后将所述容器和器械放置在可以穿透容器的辐射场中，如伽马辐射、X射线或高能量电子。辐射杀死器械上和容器内的细菌。杀菌后的器械可以储存在无菌的容器内。所述密封的容器可以保持器械无菌直至在医疗设施中被打开。
所述的任何通过引用包含于此的专利、出版物或其他公开的材料的整体或部分仅仅在被包含的材料不与本发明所陈述的现有定义、声明或其他公开材料冲突的程度上包含于此。这样，在必要的程度上，这里明确陈述的发明取代任何相冲突的通过引用包含于此的材料。所述的任何通过引用包含于此，但是与这里陈述的现有定义、声明或其他公开材料相冲突的材料仅仅在被包含的材料与现有公开材料不存在冲突的程度上包含于此。
需要保护的发明不应解释为限制于所公开的特定实施方式。因此，实施方式应被认为是描述性的而非限制性的。在不脱离本发明的精神的前提下他人可以进行变型和修改。因此，特别主张所有落在由权利要求所限定的本发明的精神和范围内的这样的等价物、变型和改变都被包含在本发明中。

Claims (10)

1.一种用于在组织上施加一个或多个外科缝钉的外科缝合器械，包括：
手柄组件；
缝合头组件，其通过轴组件与所述手柄组件可操作地联接，所述缝合头组件包括：
钉仓，其用于支撑一个或多个外科缝钉；
钉砧，其用于抵靠着所述钉仓夹住所述组织；
缝钉驱动组件，其用于接合并驱动所述缝钉，使所述缝钉从所述钉仓进入组织并抵靠所述钉砧；以及
刀，其可动地支撑在所述缝合头组件内，用于切穿被夹住的组织；
驱动系统，其用于将驱动动作施加到所述缝钉驱动组件和所述刀上；以及
反馈系统，其包括至少一个传感器，所述传感器被配置为当所述刀已切穿被夹住的组织时向指示器发送信号。
2.如权利要求1所述的外科缝合器械，其中，所述反馈系统包括支撑在所述钉砧内的刀板，且其中所述至少一个传感器由所述刀板支撑。
3.如权利要求2所述的外科缝合器械，其中，所述至少一个传感器包括附着于所述刀板的至少一根导线。
4.如权利要求3所述的外科缝合器械，其中，所述至少一根导线嵌入所述刀板中。
5.如权利要求2所述的外科缝合器械，其中，所述至少一个传感器包括磁传感器。
6.如权利要求1所述的外科缝合器械，其中，所述指示器包括从指示器组中选择的一种指示器，所述指示器组包括：发光装置、振动产生装置以及发声装置。
7.如权利要求1所述的外科缝合器械，其中，所述反馈系统被配置为当所述刀已切穿所述被夹住的组织时提供至少一种其他形式的反馈。
8.如权利要求7所述的外科缝合器械，其中，所述至少一种其他形式的反馈包括能够通过握住所述手柄组件感觉到的触觉反馈。
9.如权利要求7所述的外科缝合器械，其中，所述至少一种其他形式的反馈包括声音反馈。
10.如权利要求2所述的外科缝合器械，其中，所述刀板包括壁部分，所述壁部分被配置为在所述刀切穿所述被夹住的组织后受到所述刀切割，使得通过所述刀切穿所述刀板能够产生至少声音信号或触觉信号。
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