CN101843509A - 具有砧座锁定系统的圆形外科手术缝合器械 - Google Patents
具有砧座锁定系统的圆形外科手术缝合器械 Download PDFInfo
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Abstract
本发明公开了用于切割组织并向组织施加一个或多个外科手术缝钉的管状缝合器械。所述器械包括多种形式的砧座锁定系统，所述砧座锁定系统设计为选择性地防止所述砧座相对于所述缝合器械的所述缝合头部轴向移动。一个实施例采用了细长齿条，所述细长齿条选择性地与锁定齿轮啮合，以防止所述细长齿条和用于轴向定位所述砧座的调节轴进行轴向运动。其他实施例采用了与所述细长齿条配合的齿轮组件。锁定构件由容纳所述齿轮组件和细长齿条的手柄组件可移动地支撑。所述锁定构件被构造为选择性地啮合到所述齿轮组件，以便最终防止所述齿条和调节轴的轴向移动。
Description
技术领域
本发明整体涉及外科手术缝合器，更具体地讲，本发明涉及用于将圆形缝合器械的砧座锁定在适当位置的砧座锁定系统。
背景技术
在某些类型的外科手术中，使用外科手术缝钉已成为连接组织的优选方法，因此已开发了用于这类用途的具有特殊构造的外科手术缝合器。例如，已经开发了用于被称为吻合术的外科手术的腔内或圆形缝合器。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中有所公开，这些专利各自的全文均以引用方式并入本文中。
一种类型的吻合术包括先切除患病部分然后将肠的各个段连接到一起的外科手术。该手术需要将两个管状部分的末端重新连接到一起，以形成连续的管状通道。以前，这类外科手术既费时又费力。外科医生必须准确切割和对齐肠的两端，并且要在保持对齐状态的同时通过多次缝合将两端连起来。圆形缝合器的开发大大简化了吻合术的工序，并且也缩短了执行吻合术所需要的时间。
通常，常规圆形缝合器通常由具有近端致动机构的伸长轴和安装在该轴上的远端缝合机构组成。远端缝合机构通常包括固定的钉仓(stapling cartridge)，钉仓内含有构造成同心圆阵列的多个缝钉。圆形切刀同心安装在钉仓内缝钉以里的位置处以便在其中轴向移动。从钉仓中心轴向延伸的是活动的套管轴，该套管轴被适形为具有可拆卸地连接到其上的缝钉砧座。当把缝钉驱入其中时砧座使缝钉的末端成形。钉仓远端表面与缝钉砧座之间的距离由调节机构控制，调节机构安装在缝钉轴近端，用来控制套管的轴向移动。当外科医生启动致动机构时，对夹在钉仓和缝钉砧座之间的组织同时进行缝合和切割。
使用圆形缝合器执行吻合术时，通常采用常规的外科手术缝合器缝合肠，这种缝合器在待移除肠的患病部分两侧安置两排缝钉。在缝合相邻末端的同时切除目标段。移除患病部分后，外科医生通常将砧座插入腔管近端，即缝合线近端。这可通过将砧座头部插入外科医生在近腔管切开的入口来完成。有时，可经肛门放置砧座，即通过将砧座头部放在缝合器的远端并通过直肠插入器械。然后外科医生可用缝合线或其他常规的系结装置将肠的近端系在砧座轴上。接着，外科医生切除系结处附近多余的组织，并且外科医生将砧座连接到缝合器的套管轴上。然后外科医生合拢砧座和钉仓之间的间隙，从而将肠的近端和远端夹紧在间隙中。外科医生随后启动缝合器，驱动若干排缝钉穿过肠的两端并使其成形，从而连接末端并形成管状通道。同时，在驱动并成形缝钉时，可驱动同心的圆形刀片穿过肠组织末端，从而切割邻近内排缝钉的末端。接着，外科医生从肠中取出缝合器，并完成吻合术。
在上述外科手术的过程中，医生通常会让缝合线足够紧，以避免渗漏和流血，并实现有助于组织愈合的“组织对组织”接触。通常，通过控制施加到组织上的压力大小，可以取得良好的缝合和愈合效果。在处理较厚和较薄的组织时，要获得所需的组织压缩量存在困难。例如，当缝合较薄的组织时，需要采用压缩范围的低档以压缩组织(不能过度压缩组织)。当缝合较厚的组织时，需要在间隙设置更大的情况下实现适度的压缩。
用来测量这种压缩量的简单而可靠的方式将会是：像弹力计一样，使用适形构件和指示器来测量位移。然而，此类装置必须能够承受使缝钉成形并切断通常安装在砧座内的可分离垫圈所需的力。例如在某些情况下，这种力可以超过300lbf，并且必须控制在不产生挠曲的范围内，以确保获得正确成形的缝钉高度。但这种装置会增加使用者的使用难度。具体地讲，在正确定位砧座之后，需要让砧座在击发缝钉过程中保持不动。那些本身适形的砧座系统会促使砧座在击发过程中产生不可取的移动或挠曲，这会对缝钉的正确成形产生不利影响。
因此，需要砧座锁定系统用于在缝合过程中将砧座选择性地保持在所需位置。
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
本发明提供了用于向组织施加一个或多个外科手术缝钉的外科手术缝合器械，从而克服了现有技术存在的上述和其他缺陷。多个实施例包括手柄组件和连接到该手柄组件的轴组件。缝合头部组件可以可操作地连接到轴组件。缝合头部组件可以包括用于支撑一个或多个外科手术缝钉的钉仓、用于接合和驱动来自钉仓的缝钉的缝钉驱动器、以及可移动地支撑在缝合头部组件内的刀。外科手术缝合器械还可以包括用于向缝钉驱动器和刀施加驱动运动的驱动系统。砧座相对于钉仓被可移动地支撑，以便进行朝着和远离钉仓的轴向移动。该器械还可以包括砧座调节组件，用于选择性地调节砧座相对于钉仓的轴向位置。该器械还包括砧座锁定系统，砧座锁定系统被构造为与砧座调节组件配合，从而在相对于钉仓的轴向位置上选择性地锁定和解锁砧座。
在本发明的另一个一般方面，提供了用于向组织施加一个或多个外科手术缝钉的外科手术缝合器械。多个实施例可以包括手柄组件和可操作地连接到该手柄组件的缝合头部组件。砧座相对于缝合头部组件被可移动地支撑，以便进行选择性地朝着和远离缝合头部组件的轴向移动。砧座调节组件由手柄组件支撑，用于选择性地调节砧座相对于钉仓的轴向位置。砧座锁定系统被构造为与砧座调节组件配合，从而在相对于缝合头部的轴向位置上选择性地锁定和解锁砧座。
更具体地，本发明涉及以下内容：
(1).一种外科手术缝合器械，包括：
手柄组件；
轴组件，所述轴组件连接到所述手柄组件；
缝合头部组件，所述缝合头部组件可操作地连接到所述轴组件，所述缝合头部组件包括：
钉仓，所述钉仓用于支撑一个或多个外科手术缝钉；
缝钉驱动器，所述缝钉驱动器用于接合和驱动来自所述钉仓的所述缝钉；以及
刀，所述刀可移动地支撑在所述缝合头部组件内；
驱动系统，所述驱动系统用于向所述缝钉驱动器和所述刀施加驱动运动；
砧座，所述砧座相对于所述钉仓被可移动地支撑，以便进行朝着和远离所述钉仓的轴向移动；
砧座调节组件，所述砧座调节组件用于选择性地调节所述砧座相对于所述钉仓的轴向位置；
测力系统，所述测力系统可操作地与所述砧座调节组件相连，用于测量施加到夹在所述砧座和所述钉仓之间的组织上的压力大小；以及
砧座锁定系统，所述砧座锁定系统能够与所述砧座调节组件配合，以选择性地在相对于所述钉仓的轴向位置上锁定和解锁所述砧座。
(2).根据第(1)项所述的外科手术缝合器械，其中所述砧座调节组件包括：
调节轴，所述调节轴由所述手柄组件可移动地支撑，以便选择性地轴向穿过所述手柄组件；以及
套管针部分，所述套管针部分连接到所述调节轴，以便与所述调节轴一起轴向移动，所述套管针部分能够可拆卸地连接到所述砧座。
(3).根据第(2)项所述的外科手术缝合器械，其中所述砧座锁定系统包括：
第一锁定构件，所述第一锁定构件连接到所述调节轴和所述套管针部分之一；以及
第二锁定构件，所述第二锁定构件可移动地支撑在所述手柄组件上，所述第二锁定构件能够在锁定位置和未锁定位置之间移动，其中在所述锁定位置，所述第二锁定构件固定地接合所述第一锁定构件以防止所述第一锁定构件轴向移动。
(4).根据第(3)项所述的外科手术缝合器械，其中所述第一锁定构件包括细长齿条，所述第二锁定构件包括锁定组件，所述锁定组件可枢转地连接到所述手柄组件，并且能够在所述锁定组件固定地接合所述细长齿条的位置与所述锁定组件不接合所述细长齿条的位置之间枢转。
(5).根据第(4)项所述的外科手术缝合器械，其中所述锁定组件包括：
第一锁定齿轮，所述第一锁定齿轮与所述细长齿条啮合；以及
第二锁定齿轮，所述第二锁定齿轮相对于所述细长齿条被可移动地支撑，以便在与所述第一锁定齿轮相啮合的同时选择性地与所述细长齿条啮合。
(6).根据第(5)项所述的外科手术缝合器械，其中所述第一锁定齿轮和第二锁定齿轮可操作地支撑在锁定托架内，所述锁定托架相对于所述手柄组件被可枢转地支撑。
(7).根据第(6)项所述的外科手术缝合器械，其中所述锁定托架具有从所述锁定托架伸出的致动杆。
(8).根据第(3)项所述的外科手术缝合器械，其中所述第一锁定构件包括：
细长齿条；以及
齿轮组件，所述齿轮组件与所述细长齿条啮合，并且还被取向为选择性地与所述第二锁定构件接合。
(9).根据第(8)项所述的外科手术缝合器械，其中所述齿轮组件包括：
第一齿轮，所述第一齿轮与所述细长齿条啮合；
第二齿轮，所述第二齿轮连接到所述第一齿轮；
第三齿轮，所述第三齿轮与所述细长齿条和所述第二齿轮啮合；
第四齿轮，所述第四齿轮连接到所述第三齿轮；
第五齿轮，所述第五齿轮与所述第四齿轮啮合；以及
第六齿轮，所述第六齿轮连接到所述第五齿轮，并且被取向为选择性地与所述第二锁定构件啮合。
(10).根据第(9)项所述的外科手术缝合器械，其中所述第二锁定构件包括：
锁定杆，所述锁定杆可枢转地支撑在所述手柄组件上；以及
至少一个锁定齿，所述至少一个锁定齿形成在所述锁定杆上。
(11).一种用于将一个或多个外科手术缝钉施加到组织的外科手术缝合器械，包括：
手柄组件；
轴组件，所述轴组件连接到所述手柄组件；
缝合头部组件，所述缝合头部组件可操作地连接到所述轴组件，所述缝合头部组件包括：
钉仓，所述钉仓用于支撑一个或多个外科手术缝钉；
缝钉驱动器，所述缝钉驱动器用于接合和驱动来自所
述钉仓的所述缝钉；以及
刀，所述刀可移动地支撑在所述缝合头部组件内；
驱动系统，所述驱动系统用于向所述缝钉驱动器和所述刀施加驱动运动；
砧座，所述砧座相对于所述钉仓被可移动地支撑；
砧座调节组件，所述砧座调节组件用于选择性地调节所述砧座相对于所述钉仓的轴向位置；
用于测量施加到夹在所述砧座和所述钉仓之间的组织上的压力大小的装置；以及
用于选择性地防止所述砧座调节组件的轴向移动从而在相对于所述钉仓的位置上选择性地锁定和解锁所述砧座的装置。
(12).一种圆形外科手术缝合器械，包括：
手柄组件；
缝合头部组件，所述缝合头部组件可操作地连接到所述手柄组件；
砧座，所述砧座相对于所述缝合头部组件被可移动地支撑，以便进行选择性地朝着和远离所述缝合头部组件的轴向移动；
砧座调节组件，所述砧座调节组件由所述手柄组件支撑，用于选择性地调节所述砧座相对于所述钉仓的轴向位置；
测力系统，所述测力系统可操作地与所述砧座调节组件相连，用于测量施加到夹在所述砧座和所述缝合头部之间的组织上的压力大小；以及
砧座锁定系统，所述砧座锁定系统能够与所述砧座调节组件配合，以便在相对于所述缝合头部的轴向位置上选择性地锁定和解锁所述砧座。
(13).根据第(12)项所述的外科手术缝合器械，其中所述砧座调节组件包括：
调节轴，所述调节轴由所述手柄组件可移动地支撑，以便选择性地轴向穿过所述手柄组件；以及
套管针部分，所述套管针部分连接到所述调节轴，以便与所述调节轴一起轴向移动，所述套管针部分能够可拆卸地连接到所述砧座。
(14).根据第(13)项所述的外科手术缝合器械，其中所述砧座锁定系统包括：
第一锁定构件，所述第一锁定构件连接到所述调节轴和所述套管针部分之一；以及
第二锁定构件，所述第二锁定构件可移动地支撑在所述手柄组件上，所述第二锁定构件能够在锁定位置之间移动，其中在所述锁定位置，所述第二锁定构件固定地接合所述第一锁定构件，以防止所述第一锁定构件轴向移动。
(15).根据第(14)项所述的外科手术缝合器械，其中所述第一锁定构件包括细长齿条，所述第二锁定构件包括锁定组件，所述锁定组件可枢转地连接到所述手柄组件，并且能够在所述锁定组件固定地接合所述细长齿条的位置与所述锁定组件不接合所述细长齿条的位置之间枢转。
(16).根据第(15)项所述的外科手术缝合器械，其中所述锁定组件包括：
第一锁定齿轮，所述第一锁定齿轮与所述细长齿条啮合；以及
第二锁定齿轮，所述第二锁定齿轮相对于所述细长齿条被可移动地支撑，以便在与所述第一锁定齿轮相啮合的同时选择性地与所述细长齿条啮合。
(17).根据第(16)项所述的外科手术缝合器械，其中所述第一锁定齿轮和第二锁定齿轮可操作地支撑在锁定托架内，所述锁定托架相对于所述手柄组件被可枢转地支撑。
(18).根据第(17)项所述的外科手术缝合器械，其中所述锁定托架具有从所述锁定托架伸出的致动杆。
(19).根据第(14)项所述的外科手术缝合器械，其中所述第一锁定构件包括：
细长齿条；以及
齿轮组件，所述齿轮组件与所述细长齿条啮合并且选择性地与所述第二锁定构件接合。
(20).根据第(19)所述的外科手术缝合器械，其中所述齿轮组件包括：
第一齿轮，所述第一齿轮与所述细长齿条啮合；
第二齿轮，所述第二齿轮连接到所述第一齿轮；
第三齿轮，所述第三齿轮与所述细长齿条和所述第二齿轮啮合；
第四齿轮，所述第四齿轮连接到所述第三齿轮；
第五齿轮，所述第五齿轮与所述第四齿轮啮合；以及
第六齿轮，所述第六齿轮连接到所述第五齿轮，并且被取向为选择性地与所述第二锁定构件啮合。
附图说明
并入本文中并且构成本说明书一部分的附图示出了本发明的实施例，并且与上面所给出的概述和下面所给出的具体实施方式一起用于解释本发明的原理。
图1为本发明的外科手术缝合器械实施例的透视图，其中手柄外壳的一部分被移除；
图2为图1所示外科手术缝合器械的缝合头部组合件的分解组件图；
图3为图1的外科手术缝合器械的一部分的剖视图，其中砧座锁定系统处于解锁位置；
图4为图1和3的外科手术缝合器械的分解组件图；
图5为图1、3和4的外科手术缝合器械实施例的另一个透视图，其中手柄外壳的一部分被移除，并且砧座锁定系统处于解锁位置；
图6为图1和3-5的外科手术缝合器械实施例的一部分的另一个局部剖视图，其中砧座锁定系统处于锁定位置；
图7为本发明的另一个外科手术缝合器械实施例的一部分的局部剖视图，其中砧座锁定系统处于解锁位置；
图8为本发明的另一个外科手术缝合器械实施例的一部分的局部剖视图，其中砧座锁定系统处于解锁位置；
图9为图8的外科手术缝合器械实施例的一部分的局部剖视图，其中砧座锁定系统处于锁定位置；
图10为图8和9所示砧座锁定系统的齿轮组件与齿条的实施例的局部侧视图；并且
图11为图10的齿轮组件与齿条的实施例的顶视图。
具体实施方式
现在将描述一些示例性实施例来提供对本文公开的器械和方法的结构、功能、制造和使用原理的全面理解。这些实施例中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，并且本发明多个实施例的范围仅由权利要求书限定。结合一个示例性实施例示出或描述的特征可以与其他实施例的特征组合。这种修改形式和变型形式旨在包括在本发明的范围内。
回到附图中，其中类似的数字代表类似的部件，图中示出具有独特新型系统的圆形缝合器10，该系统用于在致动缝合器以切割组织并同时在相邻组织内形成缝钉期间将砧座锁定在适当位置。美国专利公布No.US 2008/0078806A1公开了可采用本发明的砧座锁定系统实施例的一种类型的圆形缝合器，该专利的公开内容全文以引用方式并入本文中。然而，看了本“具体实施方式”之后，本领域的普通技术人员将容易认识到，在不脱离本发明的精神和范围的情况下，本发明的多种砧座锁定系统实施例可以成功地用于各种其他圆形缝合器构型。
本文所用术语“近端”和“远端”是相对于操纵外科手术器械手柄的临床医生而言的。术语“近端”是指最靠近临床医生的部分，术语“远端”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诸如“垂直”、“水平”、“上”和“下”之类的空间术语。然而，外科手术器械能够在许多方向和位置使用，并且这些术语并非限制性和/或绝对化的。
如图1所示，公开了具有缝合头部组合件12、砧座100、调节钮350和扳机14的圆形缝合器10。缝合头部组件12经轴组件50连接到手柄组件40。当触发扳机14时，驱动系统在轴组件50内动作，使得缝钉90(图2)从缝合头部组件12中射出，从而接触砧座100。与此同时，可操作地支撑在头部组件12内的刀70动作，以切割保持在被缝合组织周边内的组织。然后将缝合器10从组织中拔出，将被缝合的组织保持在原位。
图2示出了可结合本主题发明的多个实施例使用的砧座100和缝合头部组件12的一种形式。如图所示，砧座100可以具有圆形主体部分102，该圆形主体部分具有用于将套管60(图3)连接到其上的砧座轴104。砧座主体102上具有缝钉成形下表面106。在多个实施例中，护罩120连接到砧座主体102的远端。砧座100还可设置有一对套管定位夹或片状弹簧110，用于将套管60以可脱开的方式保持在与砧座轴104接合的位置。
由图2还可看出，缝合头部组件12可以包括壳体构件20，壳体构件20用来支撑以缝钉驱动器22形式出现的钉仓支撑组件，缝钉驱动器22被适形为连接圆形钉仓24并驱动支撑在其中的缝钉90，使缝钉接触砧座100的缝钉成形下表面106。圆形刀70居中设置在缝钉驱动器22内，并具有在其上形成的远端刀刃72。壳体构件20的近端21可以通过远端套圈构件52连接到轴组件50的管状外护罩51上。
图3示出了轴组件50，该轴组件50可操作地支撑套管60和压缩轴54，以使支撑套管60和压缩轴54能在其中进行轴向移动。压缩轴54可以可活动地轴向支撑在管状外护罩51内，并且包括远端压缩轴部分55。由图3还可看出，远端压缩轴部分55连接到缝钉驱动器22。因此，压缩轴部分55在管状外护罩51内的轴向移动使得缝钉驱动器22在壳体构件20内轴向移动。触动击发扳机14将使得压缩轴54和远端压缩轴部分55向远端方向(箭头“DD”)移动，从而向远端驱动缝钉驱动器22，以发射缝钉90，使其接触砧座100的缝钉成形下表面106。当向远端驱动缝钉驱动器22时，也会驱动刀70的刀刃72，使其穿过保持在被缝合的组织周边内的组织，并进入安装在砧座100内的刀板210。
砧座调节组件(总体表示为59)包括套管60和用于使套管60(以及当与套管相连时的砧座100)相对于缝合头部组件12轴向移动的相关结构。套管60可以包括套管顶端62，套管顶端上连接有上张力带65和下张力带67。套管顶端62可通过紧固件61(如螺钉、螺柱、杆等)连接到上张力带65和下张力带67。管状护罩51内可以接纳隔带63，该隔带用于将上张力带65和下张力带67可滑动地支撑在护罩51内。上张力带65和下张力带67的近端可以连接到调节轴80的远端。如图3所示，套管60的顶端62可以插入砧座100的砧座轴104内，并通过套管定位夹110保持在接合位置。
在多个实施例中，调节轴80轴向可移动地支撑在手柄组件40内，该手柄组件可以包括两个手柄壳体段41，这两个手柄壳体段通过合适的紧固装置连在一起，以便于组装。扳机14通过枢轴销300可枢转地连接到手柄组件40。弹簧302支撑在枢轴销300上，用于使扳机14从手柄组件40偏向未致动位置。如图4所示，扳机14可以包括具有一对翅片18的扳机架构件16，翅片18的大小适于收入到击发盖310内的狭槽312中，击发盖310通过凸起58或其他合适的紧固装置连接到压缩轴56的近端57。通过转动扳机组件14，这种构造可以使压缩轴56朝远端轴向移动(箭头“DD”)和朝近端轴向移动(箭头“PD”)，下文将对此进行详细讨论。扳机组件14、压缩轴部分56、65、67以及击发盖310和其他相关部件可以组成总体表示为320的击发组件。
由图3可看出，调节轴80具有远端部分81和近端部分82，远端部分连接到上张力带65和下张力带67上，近端部分82经缩径段83与远端部分81相邻。近端部分82轴向收入到远端封头螺母330内的轴向通道332中，远端封头螺母330通过键或其他方式连接到近端封头螺母340上，从而形成总体表示为342的封头螺母组件，使得远端封头螺母330和近端封头螺母340可以一起旋转。参见图4。远端封头螺母330还可以包括向远端延伸的毂部分334，该毂部分邻接手柄组件40内形成的向内延伸的定位凸缘335。这种构造使得远端封头螺母330能够在手柄组件40内自由转动，但无法在其中轴向移动。同样，调节轴80的近端部分82轴向收入到近端封头螺母340内的轴向通道(未示出)中。此外在多个实施例中，近端封头螺母340的近端连接到封头旋钮组件350。旋转封头旋钮组件350还可以使近端封头螺母340和远端封头螺母330旋转。在多个实施例中，调节轴80可以轴向可移动地支撑在手柄组件40内，该手柄组件40的构造和类型公开在授予Todd Philip Omaits等人、提交于2006年9月29日的美国专利公布No.US-2008-0078806-A1中，该专利公布归本专利申请的受让人所有，并且全文以引用方式并入本文中。然而，在不脱离本发明的精神和范围的情况下，也可以采用其他手柄构造和击发系统构造。
由图3也可以看出，手柄组件40还可以包括砧座测力系统500，该系统为临床医生提供了监控施加到组织上的夹紧力大小的途径。例如，在一种形式中，测力系统500可以包括可透过手柄外壳41观察的指示器502。指示器502连接到调节轴80的近端85，以随调节轴一起轴向移动。调节轴80的近端部分85与调节轴80的远端部分87之间连接着适形构件，该构件可以包括弹簧504或其他构件。当向组织施加压力时，适形构件504就会根据所施加的压力大小拉伸。接着可以测量整个适形构件504的相对位移，以确定所施加的力。指示器502与校准过的刻度尺505相配合，以便向临床医生提供施加到组织上的夹紧力大小的读数。也可以采用其他测力系统。例如，还可以结合测力传感器、应变仪等，以便向临床医生指示施加到组织上力的大小。
本发明的多个实施例包括总体表示为400的独特新型砧座锁定系统，除了别的功能之外，该系统可用于在击发过程中在相对于缝合头部组件12的轴向位置上锁定砧座100。砧座锁定系统400的一个实施例包括连接到调节轴80的远端部分81的第一锁定构件402。在多个实施例中，第一锁定构件具有细长齿条402。齿条402可以与调节轴80的远端部分81一体地成形或以其他方式连接到调节轴80的远端部分81。因此，齿条402将与调节轴80一起在近端方向“PD”和远端方向“DD”上轴向移动。
如图3和4所示，砧座锁定系统400还可以包括锁定组件410，锁定组件可以可枢转地连接到手柄组件40，以便选择性地啮合到齿条402上。例如，在多个实施例中，锁定组件410可以包括第一锁定齿轮420，第一锁定齿轮可旋转地安装在手柄组件40上，并与齿条402啮合。在多个实施例中，第一锁定齿轮420可以可旋转地穿在轴销300上，轴销可将扳机架16可枢转地连接到手柄组件40。因此，第一锁定齿轮420可以绕第二锁定轴线B-B和轴销300自由旋转，第二锁定轴线B-B基本上垂直于缝合器10的纵向轴线A-A。参见图5。
锁定组件400还包括通过轴销450可旋转地固定到锁定托架440上的第二锁定齿轮430。锁定托架440具有远端442，该远端也可以可旋转地安装在轴销30上，使得锁定托架440可以围绕第二轴线B-B枢转。轴销450限定了第三轴线C-C，第三轴线也基本上垂直于纵向轴线A-A，并且基本上平行于第二轴线B-B。参见图5。轴销450将第二锁定齿轮430保持在与第一锁定齿轮420啮合的状态。
将砧座100连接到套管60之后，就可以通过使封头旋钮350相对于手柄组件40旋转来调节砧座100相对于钉仓24的轴向位置。例如，通过在一个方向上旋转封头旋钮350，可以使砧座100朝远离钉仓24的远端方向“DD”轴向前进，以增大两者之间的间隙“G”。通过在第二方向(与第一方向相反)上旋转封头旋钮350，可以将砧座100朝近端方向“PD”轴向拉向钉仓24，从而减小间隙“G”。参见图3。当临床医生将砧座100相对于钉仓24轴向定位于所需位置后，就可以击发缝合器械。在定位砧座过程中，临床医生可以通过监视测力系统500来观察施加到组织上的压力大小。当把组织以所需压缩量置于砧座100和钉仓24之间之后，就可以接合砧座锁定系统400，以便将砧座100保持在所需轴向位置。
如图3所示，砧座锁定系统400处于解锁位置。当处于解锁位置时，可以将第二锁定齿轮430转动到与细长齿条402脱离啮合的位置，从而在相对于钉仓24轴向定位砧座100时，使齿条402可以与调节轴80一起自由移动。将砧座100定位之后，临床医生只需要将锁定托架440绕第二轴线B-B枢转，即可使第二锁定齿轮430与齿条402啮合(如图6所示)。当第二锁定齿轮430与齿条402啮合时，可以防止调节轴80进一步轴向移动。由于砧座100连接到与调节轴80相连的套管60上，因此还可以防止砧座100相对于钉仓24进一步轴向移动。在缝合器械10的击发过程中，临床医生保持第二锁定齿轮430与齿条402的啮合状态。如果齿轮420、430的其中一个试图随齿条402的移动而旋转，就会被试图朝相反方向旋转的相对的锁定齿轮所阻止。
本领域的普通技术人员将会知道，这种构造能够在击发缝钉之前和击发缝钉的过程中用于将砧座100锁定在适当位置。由于第一锁定齿轮420始终与齿条402啮合，并且第二锁定齿轮430与第一锁定齿轮420啮合，因而能够在位置高度精确的情况下实现与齿条402的锁定啮合。锁定托架440和轴销300之间可以有微小间隙，以便在不影响位置精确度的情况下允许有轻微的齿条啮合误差。还应当理解，齿条402上的齿形也可以有利地设计成有利于第二锁定齿轮430在啮合过程中进行弓形运动(arcuate motion)。
在多个实施例中，锁定托架440可以设置在图1-6所示的构型中。然而，在可供选择的实施例中，锁定托架440’也可以具有细长的致动杆441(图7)，该致动杆形成杠杆臂以放大所施加的力，从而使第二锁定齿轮430枢转至与锁定齿条402锁定啮合的位置。这种构造可用来施加足够的法向力，以保持齿条402与锁定齿轮420和430之间的“三点啮合”，从而防止在缝合器械击发过程中第二锁定齿轮430与锁定齿条403脱离啮合。此外，在多个实施例中，锁定托架440可以能够与击发扳机组件14相互作用，使得击发扳机组件14以击发缝钉所需的方式的枢转也会使锁定托架440充分枢转，以使第二锁定齿轮430与锁定齿条402锁定啮合。
图8和9示出本发明的另一个圆形缝合器实施例10’的一部分，该缝合器类似于上述圆形缝合器10，但有以下区别。该实施例采用用于将砧座锁定在适当位置的多齿轮锁定系统400”。如图8-11所示，砧座锁定系统400”包括与齿条402啮合的齿轮600。当齿条402在夹紧过程(以上述方式)中移动时，齿轮600旋转。齿轮600连接到与齿轮604啮合的齿轮602。齿轮604连接到与齿轮608啮合的齿轮606。齿轮608连接到锁定齿轮610。齿轮600、608和610沿图11所示的旋转轴“RA-RA”同轴对齐。齿轮604与606在基本上平行于轴线RA-RA的第二轴线“SA-SA”上同轴对齐。在多个实施例中，如图8和9所示，扳机14上设置有至少一个齿轮齿702。要锁定齿条402从而将砧座锁定的合适位置，临床医生只需要转动可枢转地连接到扳机14的锁定杆700，从而使形成在锁定杆700上的齿轮齿702与齿轮610啮合。参见图9。
在多个实施例中，锁定系统400”可以设置有下列齿轮齿数比，例如：
齿轮600/602＝1/3齿轮齿数比。
齿轮604/606＝1/3齿轮齿数比。
齿轮608/610＝1/4齿轮齿数比。
齿轮600/610＝1/36齿轮齿数比。
在多个实施例中，齿轮600每旋转一次，齿轮610将旋转大约36次。因此，所导致的直接结果是，齿轮610可以用1/36的力大小锁定齿轮600，并且齿轮610每移动1齿，齿轮600将移动1/36齿。这样的优点在于，锁定系统需要的力为1/36，分辨率增加36倍。然而在不脱离本发明的精神和范围的情况下，也可以成功采用其他齿轮构造。
当采用圆形缝合器执行吻合术时，可以用常规外科手术缝合器来缝合肠，这种缝合器在肠的目标段(即，标本)两侧安置多排缝钉。通常在缝合的同时切割目标段。移除目标标本之后，外科医生将砧座插入肠的近端部分，即缝合线的近端。通常通过将砧座头部插入在肠近端部分切开的入口，并将砧座轴推过近端缝合线来完成上述操作。将没有砧座的缝合器械经肛门插入到远端缝合线，并将砧座套管推过缝合线。接着，外科医生将砧座连接到缝合器的套管顶端。当砧座正确连接到套管顶端之后，将砧座插入肠的远端部分。然后，外科医生开始旋转封头旋钮组件350，以便将砧座100拉向支撑在缝合头12内的钉仓24，从而闭合砧座100和钉仓24之间的间隙，并由此在间隙中将远端肠部分的近端与近端肠部分的远端接合。外科医生继续旋转封头旋钮350，直到获得所需的间隙G和组织压缩。随后，外科医生可以根据情况接合砧座锁定系统400、400’，然后压下击发扳机14以击发缝合器10。按下扳机14使得压缩轴56向远端驱动缝钉驱动器22，以驱动待驱动的缝钉90穿过肠两端。同时，在驱动并成形缝钉时，可驱动刀70穿过肠组织末端，从而切割邻近内排缝钉90的末端。
本发明的多个实施例体现了对现有圆形缝合装置的大幅改进，现有圆形缝合装置不具有将砧座锁定在击发位置的任何装置。虽然已经描述了本发明的若干实施例，但应当知道，掌握了本发明的一些或全部优点的本领域的技术人员可能会想到这些实施例的各种修改、变型和变通形式。例如，按照多个实施例，单个部件可以替换为多个部件，并且多个部件也可以替换为单个部件，以执行给定的一种或多种功能。因此，在不脱离所附权利要求书限定的已公开发明的范围和精神的情况下，本专利申请旨在涵盖所有这类修改、变型和变通形式。
本文所公开的器械可被设计为单次使用后丢弃，或者它们可被设计为可使用多次。然而，无论是哪种情况，该装置至少使用一次后经过修理后可再使用。修理可包括如下步骤的组合：拆卸该装置、然后清洗或置换某些部分以及随后组装。具体来讲，该装置可以拆卸，并且可以任意组合选择性地置换或移除任意数目的某些部分或零件。清洗和/或更换特定部件后，可到修理厂或在临外科手术前由手术组人员将器械重新装配，以供后续使用。本领域的普通技术人员将会知道，修理装置时可以采用多种不同技术来拆卸、清洗/更换和组装。这些技术的使用以及所得的经修复的装置均在本发明的范围内。
优选的是，本文所述的发明将在外科手术前进行处理。首先，获取新的或用过的器械，并根据需要进行清洗。然后对器械进行消毒。在一种消毒技术中，将器械置于闭合并密封的容器中，例如塑料或
口袋中。然后将容器和器械置于可穿透该容器的辐射场，例如γ辐射、X射线或更高能量的电子辐射。辐射可消灭器械上和容器内的细菌。然后可将消毒后的器械保存在无菌容器中。该密封容器将器械保持在无菌状态，直到在医疗设施中打开该容器。
以引用方式全文或部分地并入本文的任何专利、公布、或其他公开材料仅在所并入的材料不与本发明所述的现有定义、陈述、或其他公开材料相冲突的范围内并入本文。同样地并且在必要的程度下，本文明确阐述的公开内容取代了以引用方式并入本文的任何冲突材料。如果任何材料或材料的一部分以引用方式并入本文，但与本文所述的现有定义、陈述、或其他公开材料相冲突，那么仅在所并入的材料与现有公开材料之间不产生冲突的程度下才将其并入本文。
旨在受到保护的本发明不应被理解为受所公开的具体实施例的限制。因此应将这些实施例看作是示例性而非限制性的。在不脱离本发明精神的情况下，其他人可以进行更改和修改。因此，需要明确指出的是，本发明应涵盖落入权利要求书所限定的本发明的精神和范围内的所有这些等同形式、变型形式和修改。
Claims (10)
1.一种外科手术缝合器械，包括：
手柄组件；
轴组件，所述轴组件连接到所述手柄组件；
缝合头部组件，所述缝合头部组件可操作地连接到所述轴组件，所述缝合头部组件包括：
钉仓，所述钉仓用于支撑一个或多个外科手术缝钉；
缝钉驱动器，所述缝钉驱动器用于接合和驱动来自所述钉仓的所述缝钉；以及
刀，所述刀可移动地支撑在所述缝合头部组件内；
驱动系统，所述驱动系统用于向所述缝钉驱动器和所述刀施加驱动运动；
砧座，所述砧座相对于所述钉仓被可移动地支撑，以便进行朝着和远离所述钉仓的轴向移动；
砧座调节组件，所述砧座调节组件用于选择性地调节所述砧座相对于所述钉仓的轴向位置；
测力系统，所述测力系统可操作地与所述砧座调节组件相连，用于测量施加到夹在所述砧座和所述钉仓之间的组织上的压力大小；以及
砧座锁定系统，所述砧座锁定系统能够与所述砧座调节组件配合，以选择性地在相对于所述钉仓的轴向位置上锁定和解锁所述砧座。
2.根据权利要求1所述的外科手术缝合器械，其中所述砧座调节组件包括：
调节轴，所述调节轴由所述手柄组件可移动地支撑，以便选择性地轴向穿过所述手柄组件；以及
套管针部分，所述套管针部分连接到所述调节轴，以便与所述调节轴一起轴向移动，所述套管针部分能够可拆卸地连接到所述砧座。
3.根据权利要求2所述的外科手术缝合器械，其中所述砧座锁定系统包括：
第一锁定构件，所述第一锁定构件连接到所述调节轴和所述套管针部分之一；以及
第二锁定构件，所述第二锁定构件可移动地支撑在所述手柄组件上，所述第二锁定构件能够在锁定位置和未锁定位置之间移动，其中在所述锁定位置，所述第二锁定构件固定地接合所述第一锁定构件以防止所述第一锁定构件轴向移动。
4.根据权利要求3所述的外科手术缝合器械，其中所述第一锁定构件包括细长齿条，所述第二锁定构件包括锁定组件，所述锁定组件可枢转地连接到所述手柄组件，并且能够在所述锁定组件固定地接合所述细长齿条的位置与所述锁定组件不接合所述细长齿条的位置之间枢转。
5.根据权利要求4所述的外科手术缝合器械，其中所述锁定组件包括：
第一锁定齿轮，所述第一锁定齿轮与所述细长齿条啮合；以及
第二锁定齿轮，所述第二锁定齿轮相对于所述细长齿条被可移动地支撑，以便在与所述第一锁定齿轮相啮合的同时选择性地与所述细长齿条啮合。
6.根据权利要求5所述的外科手术缝合器械，其中所述第一锁定齿轮和第二锁定齿轮可操作地支撑在锁定托架内，所述锁定托架相对于所述手柄组件被可枢转地支撑。
7.根据权利要求6所述的外科手术缝合器械，其中所述锁定托架具有从所述锁定托架伸出的致动杆。
8.根据权利要求3所述的外科手术缝合器械，其中所述第一锁定构件包括：
细长齿条；以及
齿轮组件，所述齿轮组件与所述细长齿条啮合，并且还被取向为选择性地与所述第二锁定构件接合。
9.根据权利要求8所述的外科手术缝合器械，其中所述齿轮组件包括：
第一齿轮，所述第一齿轮与所述细长齿条啮合；
第二齿轮，所述第二齿轮连接到所述第一齿轮；
第三齿轮，所述第三齿轮与所述细长齿条和所述第二齿轮啮合；
第四齿轮，所述第四齿轮连接到所述第三齿轮；
第五齿轮，所述第五齿轮与所述第四齿轮啮合；以及
第六齿轮，所述第六齿轮连接到所述第五齿轮，并且被取向为选择性地与所述第二锁定构件啮合。
10.根据权利要求9所述的外科手术缝合器械，其中所述第二锁定构件包括：
锁定杆，所述锁定杆可枢转地支撑在所述手柄组件上；以及
至少一个锁定齿，所述至少一个锁定齿形成在所述锁定杆上。
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| CN106659502A (zh) * | 2014-07-04 | 2017-05-10 | 柯惠有限合伙公司 | 用于外科吻合装置的具有装运构件的装载单元 |
| US10405864B2 (en) | 2014-07-04 | 2019-09-10 | Covidien Lp | Loading unit with shipping member for surgical stapling device |
| CN106659502B (zh) * | 2014-07-04 | 2019-03-01 | 柯惠有限合伙公司 | 用于外科吻合装置的具有装运构件的装载单元 |
| US10499916B2 (en) | 2014-12-11 | 2019-12-10 | Covidien Lp | Surgical stapling loading unit |
| WO2016090594A1 (en) * | 2014-12-11 | 2016-06-16 | Covidien Lp | Surgical stapling loading unit |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2233084A1 (en) | 2010-09-29 |
| CN101843509B (zh) | 2014-10-22 |
| EP2233084B1 (en) | 2020-11-25 |
| JP2010221027A (ja) | 2010-10-07 |
| US20100237132A1 (en) | 2010-09-23 |
| JP5528864B2 (ja) | 2014-06-25 |
| US8066167B2 (en) | 2011-11-29 |
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