CN102783983B - 用于圆形缝合器的低成本砧座组件 - Google Patents
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Abstract
本发明提供了一种用于圆形缝合器械的砧座组件。所述砧座组件包括一件式聚合物砧座和缝钉成型表面。所述一件式聚合物砧座包括砧座底表面和从所述砧座底表面延伸的砧座轴。所述缝钉成型表面附接到所述砧座底表面。
Description
技术领域
本发明总体涉及用于圆形缝合器的砧座组件。
背景技术
圆形缝合器械是外科手术领域熟知的用于肠外科手术的缝合器械。此类器械的一个实例是由EthiconEndoSurgeryInc制造的EndopathILSECS25内窥镜式弯曲管腔内缝合器(EndopathILSECS25EndoscopicCurvedIntraluminalStapler)。存在许多圆形缝合器专利,例如,授予Becht的美国专利No.4,207,898、授予Noiles的美国专利No.4,351,466、授予Bilotti等人的美国专利No.5,292,053、以及授予Green等人的美国专利No.5,344,059。
圆形缝合器械通常使用通过加工单件金属而制成的砧座组件。由于涉及大量的加工,这些砧座组件制造昂贵。其他圆形缝合器械使用提供结构支承的金属基部以及主要在本质上用于装饰的模制特征。另外一些圆形缝合器械采用设计复杂因而制造昂贵的组合设计。
需要一种用于圆形缝合器械的砧座组件和用于制造该组件的方法来降低现有砧座组件涉及的大部分成本。
发明内容
本发明由权利要求限定,此部分的任何内容都不应看作是对这些权利要求的限制。
在一个方面,提供了一种用于圆形缝合器械的砧座组件。该砧座组件包括一件式聚合物砧座和缝钉成型表面。该一件式聚合物砧座包括砧座底表面和从砧座底表面延伸的砧座轴。缝钉成型表面附接到砧座底表面。
在另一方面,提供了一种圆形缝合器械。该圆形缝合器械包括柄部、砧座控制构件、往复传动轴和砧座组件。往复传动轴连接到砧座控制构件。砧座组件连接到往复传动轴。砧座组件包括具有砧座底表面和从砧座底表面延伸的砧座轴的一件式聚合物砧座、以及附接到砧座底表面的缝钉成型表面。
在又一个方面,提供了一种制造砧座组件的方法。在一个步骤中,将缝钉成型表面设置在模具内。在另一个步骤中,通过将砧座在模具内模制到缝钉成型表面而形成砧座组件。模制的砧座被模制成具有从砧座底表面延伸的砧座轴。
具体地,本发明涉及以下内容:
(1).一种用于圆形缝合器械的砧座组件,包括:
一件式聚合物砧座,所述一件式聚合物砧座包括砧座底表面和从所述砧座底表面延伸的砧座轴;和
缝钉成型表面,所述缝钉成型表面附接到所述砧座底表面。
(2).根据第(1)项所述的砧座组件,其中所述砧座轴包括至少一个对齐表面。
(3).根据第(1)项所述的砧座组件,其中所述砧座包括延伸通过所述砧座轴和所述砧座底表面的孔。
(4).根据第(3)项所述的砧座组件,其中金属轴延伸通过所述孔。
(5).根据第(4)项所述的砧座组件,其中所述金属轴的第一端伸出所述砧座底表面内的所述孔,并且紧靠所述砧座底表面的顶部,所述金属轴的第二端伸出所述砧座轴内的所述孔。
(6).根据第(5)项所述的砧座组件,其中所述金属轴附接到所述一件式聚合物砧座。
(7).根据第(1)项所述的砧座组件,还包括附接到所述砧座底表面的分离式垫圈。
(8).根据第(1)项所述的砧座组件,其中所述砧座轴包括延伸到并不延伸通过所述砧座底表面的所述砧座轴内的孔。
(9).根据第(8)项所述的砧座组件,还包括延伸到所述砧座轴的所述孔内的金属轴。
(10).根据第(9)项所述的砧座组件,其中所述金属轴附接到所述一件式聚合物砧座。
(11).一种圆形缝合器械,包括:
柄部;
砧座控制构件;
往复传动轴,所述往复传动轴连接到所述砧座控制构件;和
砧座组件,所述砧座组件连接到所述往复传动轴并包括具有砧座底表面和从所述砧座底表面延伸的砧座轴的一件式聚合物砧座以及附接到所述砧座底表面的缝钉成型表面。
(12).根据第(11)项所述的圆形缝合器械,其中所述砧座轴包括至少一个对齐表面。
(13).根据第(11)项所述的圆形缝合器械,其中所述砧座轴包括延伸通过所述砧座轴和所述砧座底表面的孔,金属轴的第一端伸出所述砧座底表面内的所述孔,并且紧靠所述砧座底表面的顶部,所述金属轴的第二端伸出所述砧座轴内的所述孔,并且所述金属轴附接到所述砧座轴和所述往复传动轴。
(14).根据第(11)项所述的圆形缝合器械,其中所述砧座轴包括延伸到并不延伸通过所述砧座底表面的所述砧座轴内的孔,金属轴延伸到所述砧座轴的所述孔内,并且所述金属轴附接到所述砧座轴和所述往复传动轴。
(15).根据第(11)项所述的圆形缝合器械,还包括连接到所述柄部的轴组件和连接到所述轴组件的壳体,其中所述砧座控制构件能够使所述砧座底表面从远离所述壳体的打开位置运动到邻近所述壳体的关闭位置。
(16).一种制造砧座组件的方法,包括:
将缝钉成型表面设置到模具内;以及
通过将砧座在所述模具内模制到所述缝钉成型表面来形成所述砧座组件,使得所模制的砧座被模制成具有从砧座底表面延伸的砧座轴。
(17).根据第(16)项所述的方法,还包括将另一轴附接到所形成的砧座组件的所述砧座轴。
(18).根据第(16)项所述的方法,还包括将分离式垫圈附接到所形成的砧座组件的所述砧座底表面。
(19).根据第(16)项所述的方法,其中所述设置还包括将预制轴设置在所述模具内,并且所述形成还包括将所述砧座轴在所述模具内模制到所述预制轴以形成所述砧座组件。
(20).根据第(16)项所述的方法,其中所述形成还包括在所述模具内将所述砧座轴模制成具有至少一个砧座对齐表面。
附图说明
结合以下附图和描述可以更好地理解本公开。附图中的部件未必按比例绘制,而是重点放在示出本公开的原理上。
图1示出根据一个优选实施例的具有开放组装结构的可重复使用的圆形缝合器械的透视图;
图2示出图1的可重复使用的圆形缝合器械的透视图,其中器械处于打开位置,使得砧座组件与可重复使用的圆形缝合器械的其余部分分开;
图3示出图1的可重复使用的圆形缝合器械的柄部和轴组件的分解透视图;
图3A示出图3的可重复使用的圆形缝合器械的往复式砧座调节杆的一部分沿线3A-3A截取的剖视图;
图3B示出图3的可重复使用的圆形缝合器械的往复式砧座调节杆的另一部分沿线3B-3B截取的剖视图;
图4示出图1的可重复使用的圆形缝合器械的缝钉重装载组件的分解透视图;
图5示出图1的可重复使用的圆形缝合器械的缝钉重装载组件在未组装构型下的局部剖视图;
图6示出沿组装构型下的图1的可重复使用的圆形缝合器械的缝钉重装载组件截取的剖视图,其中砧座组件处于打开位置,环形刀片处于预击发位置;
图7示出图6的视图,其中砧座组件运动到关闭位置,环形刀片仍处于预击发位置;
图8示出图1的可重复使用的圆形缝合器械的砧座组件的分解透视图;
图9示出对齐圆形缝合器械的缝钉重装载组件的方法的一个实施例的流程图;
图10示出砧座组件的另一个实施例的分解透视图;
图11示出图1的可重复使用的圆形缝合器械的透视图,其中砧座组件被替换成与可重复使用的圆形缝合器械的其余部分分离的图10的砧座组件;
图12示出砧座组件的又一个实施例的分解透视图;
图13示出图1的可重复使用的圆形缝合器械的透视图,其中砧座组件被替换成与可重复使用的圆形缝合器械的其余部分分离的图12的砧座组件;
图14示出一个流程图,图中显示了制造砧座组件的方法的一个实施例;
图15A和15B示出图1的可重复使用的圆形缝合器械的砧座闭合旋钮和往复式砧座调节杆在不同组装阶段的透视组装图;
图16A和16B示出与图15A和15B的往复式砧座调节杆相连的砧座闭合旋钮与图1的可重复使用的圆形缝合器械的柄部在不同组装阶段的透视组装图;
图17A、17B和17C示出图16A和16B的与往复式砧座调节杆相连的砧座闭合旋钮和柄部及图1的可重复使用的圆形缝合器械的击发杆在不同组装阶段的透视组装图;
图18A和18B示出图17A、17B和17C的与往复式砧座调节杆相连的砧座闭合旋钮、柄部和击发杆及图1的可重复使用的圆形缝合器械的载体盖在不同组装阶段的透视组装图;
图19A、19B和19C示出图18A和18B的与往复式砧座调节杆相连的砧座闭合旋钮、柄部、击发杆和载体盖及图1的可重复使用的圆形缝合器械的轴组件在不同组装阶段的透视组装图;
图20示出根据另一个优选实施例的具有开放组装结构的弯曲的可重复使用的圆形缝合器械的透视图;
图21示出图20的弯曲的可重复使用的圆形缝合器械的分解透视图;
图22示出具有摩擦减小构件的弯曲的圆形缝合器械的剖视图,其中器械处于打开状态;
图23示出具有摩擦减小构件的弯曲的圆形缝合器械的剖视图,其中器械处于击发缝钉之前的关闭位置;
图24示出具有摩擦减小构件的弯曲的圆形缝合器械的剖视图,其中器械处于击发缝钉之后的完全击发状态;
图25示出具有摩擦减小构件的弯曲的圆形缝合器械的击发杆的透视图;
图26示出具有摩擦减小构件的圆形缝合器械的击发杆的分解透视图;
图27示出具有摩擦减小构件的圆形缝合器械的击发杆的剖视图;
图28示出具有与往复式砧座调节杆相邻的摩擦减小构件的替代实施例的圆形缝合器械的击发杆的放大侧视图;
图29示出图4的圆形缝合器械的缝钉重装载组件的环形刀片的剖视图;
图30示出附接到保护构件的环形分离式垫圈的透视图;
图31示出图7的视图,其中环形刀片运动到已击发位置对环形分离式垫圈进行切割,同时砧座组件处于关闭位置;
图32示出在图31的环形刀片的虚线圆内的近距离视图,图中示出了切割环形分离式垫圈的环形刀片;
图33示出图31的视图,其中砧座组件在环形刀片被击发之后已返回到打开位置;
图33A示出连接到可重复使用的圆形缝合器械的柄部的砧座控制构件的一个实施例的近距离侧视图;
图34示出图33的视图,其中砧座组件的砧座已从圆形缝合器械上移除,并且环形分离式垫圈和保护构件附接到环形刀片上;
图35示出图34的视图,其中新的砧座已试图附接到缝钉重装载组件,而保护构件和环形分离式垫圈则妨碍这种附接;
图36示出图35的虚线圆内的近距离视图,图中示出了妨碍将新砧座附接到缝钉重装载组件的保护构件和环形分离式垫圈;
图37示出将刀片锁定到圆形缝合器械的分离式垫圈的方法的一个实施例的流程图;
图38示出沿图1的可重复使用的圆形缝合器械截取的剖视图,其中砧座组件设置在击发区外远离壳体的打开位置,并且击发扳机处于锁定的预击发状态;
图38A示出近距离视图,显示了在图17C的组装状态下击发扳机和击发杆之间的关系;
图39示出图38的剖视图的局部透视图;
图40示出沿图38的线40-40截取的剖视图;
图41示出沿图1的可重复使用的圆形缝合器械截取的剖视图,其中砧座组件设置在击发区内与壳体相邻的关闭位置,并且击发扳机处于解锁的准备击发的预击发状态;
图42示出图41的剖视图的局部透视图;
图43示出沿图41的线43-43截取的剖视图;
图44示出沿图1的可重复使用的圆形缝合器械截取的剖视图,其中砧座组件设置在击发区内与壳体相邻的关闭位置,并且击发扳机已被击发;
图45示出图44的剖视图的局部透视图;
图46示出沿图44的线46-46截取的剖视图;以及
图47A和47B示出处于附接到柄部状态的缝钉重装载组件的剖视图,其中砧座分别处于打开状态和关闭状态。
具体实施方式
参照图1,图中示出了根据本发明的用于从患者移除组织的新型手术圆形缝合器械100。手术圆形缝合器械100可用来移除包括内痔或其他类型的人体组织的组织。圆形缝合器械100已对如美国专利No.6,102,271所示的常规圆形缝合器械进行改进,该专利的内容以引用方式全文并入本文中。圆形缝合器械100具有缝钉重装载组件102,该组件能够使环形阵列的缝钉104(参见图7和31)放入内痔底部处的粘膜层内,并且能够使粘膜组织和内痔一起从直肠或肛门的内壁切除。通常,圆形缝合器械100可用来将两段肠子与缝钉104(参见图7和31)的环形圈吻合在一起,同时从环形缝钉圈的中央切下塞子,用作粪便通道。
参照图1-2,圆形缝合器械100包括人类工程学轴组件106、具有壳体110的钉仓组件108、以及可拆卸地连接到往复式砧座调节杆114的砧座组件112。圆形缝合器械的缝钉重装载组件102包括钉仓组件108和砧座组件112。如图1-3所示,圆形缝合器械100还包括形成腔体118的柄部116。砧座控制构件120位于柄部116的近端,并且与砧座组件112可操作地相连,使得砧座控制构件120的旋转使砧座组件112向近端或远端运动,具体取决于砧座控制构件120的旋转方向。砧座控制构件120可包括砧座闭合旋钮或其他类型的砧座控制构件。圆形缝合器械100包括在方向124上从所示打开位置到关闭位置可旋转的击发扳机122,其中在关闭位置,缝钉104(参见图7和31)被射入组织(参见图31)内,并且用缝钉重装载组件102的环形刀片126(参见图31)切掉多余组织。安全闩锁128位于击发扳机122上,并且在图中示出为防止操作击发扳机122的向上的接合位置。当安全闩锁128脱开并在方向128a上向内向下运动时,击发扳机122可以在方向124上从打开位置到关闭位置自由旋转。轴组件106从柄部116向远端延伸,并且在近端处利用附接到柄部116的螺纹部分132(参见图3)的连接螺母130与柄部116可拆卸地相连。壳体110的相对的附接构件134(参见图4)在轴组件106的远端处可拆卸地连接到接纳构件136(参见图3)。附接构件134包括可偏置的按扣构件,接纳构件136包括小孔。在其他实施例中,附接构件134和接纳构件136可包括任何类型的配合构件。
如图2所示,壳体110包括具有喇叭形驱动部分140和外部管状驱动部分142的外表面138。通道144包括从喇叭形驱动部分140延伸到外部管状驱动部分142的壳体表面孔。环状缝钉保持器148(参见图4-5、7和31)附接到壳体110的远端内,使得缝钉保持器148的附接构件150(参见图4、7和31)可拆卸地连接到壳体110的接纳构件152(参见图4、7和31)。附接构件150包括按扣凸起,接纳构件152包括可偏置按扣。在其他实施例中,附接构件150和接纳构件152可各自包括任何类型的可附接构件。环状缝钉保持器148包括用于保持和发射缝钉104(参见图31)的环形阵列的缝钉槽154(参见图4、7和31)。
如图4-7所示,缝钉驱动器156通过缝钉驱动器156的键158(参见图4)可滑动地连接到环状缝钉保持器148,从而提供了一种可拆卸地连接到环状缝钉保持器148的键槽160(参见图4)的构造。缝钉驱动器156通过缝钉驱动器156的环形外驱动表面164的对齐槽162可动地安装在壳体110内,对齐槽162可动地连接到壳体110的环形内壳体表面168的对齐花键166,以允许缝钉驱动器156在壳体110内纵向运动,同时防止缝钉驱动器156在壳体110内旋转。缝钉驱动器156的外驱动表面164具有喇叭形驱动部分170和外部管状驱动部分171。对齐槽162和对齐花键166被设置成平行于缝钉驱动器156的纵向轴线172和壳体110的纵向轴线174。在其他实施例中,壳体110和缝钉驱动器156可以使用允许纵向运动的任何数量、类型或构型的对齐构件彼此对齐。
缝钉驱动器156具有接纳在缝钉保持器148内的缝钉槽154中的多个指状物176。在通过启动击发扳机122(参见图3)而使缝钉驱动器156从预击发位置(参见图7)向已击发位置(参见图31)运动时,指状物176用于从缝钉保持器148的缝钉槽154接合并驱动多个缝钉104(参见图31)。如图4和7所示,缝钉驱动器156的柔性制动构件178可拆卸地连接到壳体110的制动凸耳180。该构造仅当击发杆282(参见图44-46)在缝钉驱动器156上施加预定量的力时允许缝钉驱动器156纵向运动。当施加了所需力时,缝钉驱动器156上的可偏置制动构件178向内弯曲,从而从壳体110上的制动凸耳180分离,以允许缝钉驱动器156向远端纵向运动。在其他实施例中,柔性制动构件178和制动凸耳180可包括其他类型的配合构件。
环形刀片126安装在缝钉驱动器156远端内,并且通过多个刀片安装销182(参见图5和31)附接,刀片安装销从环形刀片126的基部186内的同样数量的安装孔184中伸出。环形刀片126具有在基部186内的刀片开口188(参见图5和31)。环形刀片126的开放远端190(参见图4、29和31)具有刀刃192。当利用击发扳机122(参见图3)使缝钉驱动器156从图7的预击发位置向远端运动到图31的已击发位置时,环形刀片126与缝钉驱动器156一起运动。当击发扳机122被击发时,击发扳机122在方向124上从其在图38-43中的位置旋转至图44-46的位置,迫使壳体110内配合的击发杆282在方向392上紧靠缝钉驱动器156运动,并迫使缝钉驱动器也在壳体110内在方向392上运动。这种运动使缝钉驱动器156及其附接的环形刀片126从其在图7和38-43中的预击发位置向其在图31和44-46中的已击发位置击发。在击发缝钉驱动器156的过程中,缝钉驱动器156的指状物176将缝钉104从其在图7中所示的缝钉保持器148内的预击发位置向其在图31中所示的离开缝钉保持器148的已击发位置击发。
往复式砧座调节杆114(参见图4和6)位于钉仓组件108内,并且设置成延伸通过缝钉驱动器156的环形内轴194(参见图4和6)并在其中运动。如图3A和3B所示,往复式砧座调节杆114的横截面在形状和尺寸上变化,使得沿剖面线3A-3A截取的一部分为圆形形状并具有如图3A所示的直径401,沿剖面线3B-3B截取的另一部分具有平行侧壁,这两个侧壁由如图3B所示的比直径401小的距离402隔开。如图4所示,环形内轴194在缝钉驱动器156内沿着与缝钉驱动器156的纵向轴线172平行的方向纵向延伸。孔196在环形内轴194内延伸。砧座对齐表面198沿环形内轴194的环形内表面200纵向延伸。砧座对齐表面198包括至少一个纵向狭槽。在其他实施例中,砧座对齐表面198可包括具有不同构型的任何数量或类型的对齐表面。环形内轴194的外表面204与缝钉驱动器156的另一个环形内表面206间隔开,使得环形孔208在环形内轴194的外表面204和环形内表面206之间延伸。
参照图1、2、4-7,尤其参照图8,砧座组件112包括砧座210、缝钉成型表面212、环形分离式垫圈214和金属轴216。砧座210为一件式聚合物模制部件,其具有一体地模制到砧座底表面220的砧座轴218。砧座210由包含玻璃填充或碳填充尼龙的聚合物制成。在其他实施例中,砧座210可以由类似的复合材料制成,该材料具有大于15,000psi的拉伸强度,以免在组织力的作用下过度弯曲。
砧座底表面220模制到缝钉成型表面212和金属轴216。在其他实施例中,砧座底表面220可使用不同的附接机构附接到缝钉成型表面212。缝钉成型表面212由包括不锈钢的金属薄板或板制成,其在形状上为环形,并且包括缝钉成型凹部。在其他实施例中,缝钉成型表面212可以由铝或能承受缝钉成型力的其他材料制成。
环形分离式垫圈214压力配合到砧座底表面220的腔体222内并邻近砧座底表面220。在其他实施例中,环形分离式垫圈214能够利用不同的附接机构附接到砧座底表面220的腔体222内。环形分离式垫圈214由包括ABS(丙烯腈-丁二烯-苯乙烯)的塑料制成。在其他实施例中,环形分离式垫圈214可由尼龙、聚乙烯或聚丙烯制成。
砧座轴218模制在金属轴216的末端226的外表面224周围,使得金属轴216延伸到砧座轴218的模制孔228内。砧座轴218的模制孔228终止于砧座轴218内,并且不延伸通过砧座底表面220的远端。砧座轴218的内表面230具有接纳构件232,接纳构件232模制到金属轴216的末端226的外表面224的附接构件234。接纳构件232具有模制环形肋(图38),附接构件234具有环形槽(图8)。在其他实施例中,接纳构件232和附接构件234可包括凹槽和螺纹、凹构件和凸构件、或其他类型的附接机构。在另一些实施例中,砧座轴218可以利用不同的附接机构附接到金属轴216。近端槽236延伸通过金属轴216。金属轴216的末端238包括伸展槽240(参见图2)。金属轴216由不锈钢制成。在其他实施例中,金属轴216可由不同材料制成。
在制造砧座组件112时,金属轴216和缝钉成型表面212被预制。然后,将预制金属轴216和预制缝钉成型表面212插入注塑模具内。然后,利用模制在模具内形成砧座210,从而将砧座210模制到预制金属轴216和预制缝钉成型表面212。在模制过程中,砧座底表面220成型并且模制到预制缝钉成型表面212,同时砧座轴218成型并且模制到预加工金属轴216的末端226周围。然后,将环形分离式垫圈214压力配合到模制砧座底表面220的腔体222内。在其他实施例中,制造过程可以变化。
往复式砧座调节杆114的接合构件244(参见图2和6)利用搭扣配合连接可拆卸地连接到金属轴216的近端槽236内。该构造将金属轴216和附接的砧座210可操作地连接到往复式砧座调节杆114的砧座控制构件120。在其他实施例中,往复式砧座调节杆114的接合构件244可以利用其他附接机构附接到金属轴216。伸展槽240允许金属轴216的末端238在连接到往复式砧座调节杆114的接合构件244的过程中伸展。在将圆形缝合器械100在患者身上使用之后,丢弃整个砧座组件112。在随后的工序中,使用包括新的砧座组件112的新缝钉重装载组件102。
如图8所示,砧座轴218包括在模制砧座210时形成的对齐表面246。对齐表面246包括设置成平行于砧座轴218的纵向轴线248的至少一个花键。对齐表面246沿着砧座轴218的环形外表面252从砧座轴218的顶部250延伸至砧座轴218的底部254。砧座组件112的金属轴216不包括对齐表面。在其他实施例中,对齐表面246可包括具有不同构型的任何数量或类型的对齐表面。例如,如图12所示,在砧座组件112仅包括砧座轴218而没有附接到砧座组件112的金属轴216的实施例中,对齐表面246可以沿着砧座轴218的环形外表面252从砧座轴218的顶部250延伸并停在砧座轴218的中部256处,而不延伸到砧座轴218的底部254。
砧座组件112可从打开位置(参见图6)运动到关闭位置(参见图7),其中,在打开位置,缝钉成型表面212被设置成远离壳体110以接纳组织,在关闭位置,缝钉成型表面212被设置成邻近钉仓组件108的壳体110,以将组织夹在缝钉保持器148和缝钉成型表面212之间,然后击发缝钉驱动器156以缝合和切割夹着的组织。这是由于往复式砧座调节杆114的接合构件244的末端242(参见图2和6)在缝钉驱动器156的环形内轴194中延伸并连接在砧座组件112的金属轴216的近端238的槽236内。因此,由于相连的往复式砧座调节杆114运动,连接到金属轴216的砧座轴218可动地设置在缝钉驱动器156的环形内轴194中,以允许砧座组件112的缝钉成型表面212相对于缝钉驱动器156和壳体110运动。
砧座轴218的对齐表面246(参见图8)能够与缝钉驱动器156的砧座对齐表面198(参见图4)配合,以便在砧座底表面220处于邻近钉仓组件108的关闭位置(参见图7)时旋转地对齐缝钉成型表面212和缝钉保持器148。初始地,如图6所示,当往复式砧座调节杆114运动金属轴216和附接的砧座轴218,从而将砧座底表面220从图6所示打开位置朝图7所示关闭位置运动时,砧座轴218的对齐表面246(参见图8)不与缝钉驱动器156的环形内轴194的砧座对齐表面198(参见图4)配合,因为砧座对齐表面198将仅被设置成邻近缺少对齐表面的金属轴216。在此期间,缝钉成型表面212不会与缝钉保持器148旋转地对齐。然而,如图7所示,当砧座轴218的对齐表面246触及缝钉驱动器156的环形内轴194时,对齐表面246将与环形内轴194的砧座对齐表面198配合,从而当砧座底表面220进入邻近钉仓组件108的关闭位置时,可旋转地对齐缝钉成型表面212和缝钉保持器148。参见图33A,邻近砧座控制构件120的标记120A在视觉上指示砧座112的缝钉成型表面212(参见图7)和缝钉导向器148(参见图7)之间的间隙距离,以便为使用者提供有关压缩的组织厚度的反馈。当器械几乎完全闭合时,往复式砧座调节杆114的近端射入砧座控制构件120内的孔120F。
当砧座组件112处于图7的关闭位置,且圆形缝合器械100被击发而将缝钉驱动器156从其在图7中所示的壳体110内的预击发位置运动到其在图31中所示的已击发位置时,缝钉驱动器156的指状物176将缝钉104从缝钉保持器148的缝钉槽154驱动至紧贴砧座组件112的缝钉成型表面212。缝钉成型表面212将射出的缝钉104成形为闭合的缝钉形状,从而将组织的一部分缝合在一起。同时,缝钉驱动器156将环形刀片126驱动进入夹在砧座210上的缝钉成型表面212和缝钉导向器148的表面之间的被压缩组织内,从而紧贴砧座组件112的分离式垫圈214切割组织。
图9示出流程图258,该流程图示出了对齐圆形缝合器械的缝钉重装载组件的方法的一个实施例。在步骤260中,提供了圆形缝合器械的缝钉重装载组件。所提供的圆形缝合器械包括壳体、附接到壳体的缝钉保持器、缝钉驱动器、环形刀片、以及砧座。在步骤262中,缝钉驱动器以对齐构型活动安装在壳体内,并且缝钉驱动器的附接构件连接到壳体的接纳构件,以防止在用击发杆向缝钉驱动器施加预定量的力之前缝钉驱动器运动超过壳体内的某个点。在步骤264中,砧座的砧座底表面从远离壳体的打开位置朝邻近壳体的关闭位置运动,其中在打开位置,砧座的缝钉成型表面不与附接到壳体的缝钉保持器旋转对齐。在步骤266中,砧座的对齐表面与缝钉驱动器的砧座对齐表面配合,以便在砧座底表面处于邻近壳体的关闭位置时旋转地对齐砧座的缝钉成型表面和缝钉保持器。砧座的对齐表面包括至少一个花键,缝钉驱动器的砧座对齐表面包括至少一个狭槽。在其他实施例中,砧座的对齐表面和驱动器的砧座对齐表面的数量、类型与构型可以变化。
本公开的一个或多个实施例可以解决与此前手术圆形缝合器械内的对齐相关的一个或多个问题。例如,利用本公开的一个或多个实施例可以直接在砧座和缝钉驱动器之间提供正确的对齐,而不必像在现有器械中那样需要在砧座与壳体之间的第一对齐和在缝钉驱动器与壳体之间的第二对齐。这种直接对齐驱动器和砧座的方法降低了对齐误差的可能,并产生改进的缝钉形状。
图10示出包括砧座210A、缝钉成型表面212A、环形分离式垫圈214A和金属轴216A的砧座组件112A的另一个实施例的分解图。砧座210A为具有模制到砧座底表面220A的砧座轴218A的一件式聚合物模制部件。砧座210A由包含玻璃填充或碳填充尼龙的聚合物制成。在其他实施例中,砧座210A可以由类似的复合材料制成,该材料具有大于15,000psi的拉伸强度,以免在组织力的作用下过度弯曲。
金属轴216A延伸通过模制孔228A,模制孔228A延伸通过砧座轴218A和砧座底表面220A。金属轴216A的一端226A伸出模制孔228A之外并紧靠砧座底表面220A的顶部268。金属轴216A的末端226A具有比模制孔228A的直径272大的直径270。金属轴216A的另一端238A伸出砧座轴218A的模制孔228A之外。金属轴216A包括附接到砧座轴218A的接纳构件(被遮挡)的附接构件(被遮挡)。附接构件包括螺纹,接纳构件包括凹槽。在其他实施例中,附接构件和接纳构件可包括凸构件和凹构件或其他类型的附接机构。在另一些实施例中,金属轴216A可以利用不同的附接机构附接到砧座轴218A。槽236A在金属轴216A的近端238A内延伸。金属轴216A的末端238A也包括伸展槽240A。金属轴216A由包括热处理不锈钢的金属制成。在其他实施例中,金属轴216A可由其他钢制成。
砧座底表面220A模制到缝钉成型表面212A。在其他实施例中,砧座底表面220A可使用不同的附接机构附接到缝钉成型表面212A。缝钉成型表面212A由包括奥氏体不锈钢的金属薄板制成,其在形状上为环形,并且包括缝钉成型凹部。在其他实施例中,缝钉成型表面212A可由其他金属、不锈钢、铝的薄板或板制成。
环形分离式垫圈214A压力配合到砧座底表面220A的腔体222A内并邻近砧座底表面220A。在其他实施例中,环形分离式垫圈214A能够利用不同的附接机构附接到砧座底表面220A的腔体222A内。环形分离式垫圈214A由包括ABS(丙烯腈-丁二烯-苯乙烯)的塑料制成。在其他实施例中,环形分离式垫圈214A可由尼龙、聚乙烯或聚丙烯制成。
在制造砧座组件112A时,缝钉成型表面212A被预制。然后,将预制缝钉成型表面212A插入注塑模具内。然后,利用模具在模具内形成砧座210A,以将砧座210A模制到缝钉成型表面212A。在模制过程中,砧座底表面220A成型并且模制到缝钉成型表面212A。然后,将环形分离式垫圈214A压力配合到模制砧座底表面220A的腔体222A内。在模制砧座底表面220A之后,预制金属轴216A的末端238A延伸到砧座底表面220A内的模制孔228A中并离开砧座轴218A内的模制孔228A,以使得金属轴216A的末端226A紧靠砧座底表面220A的顶部268。使用者可以在使用之前进行此步骤。当预制金属轴216A的末端238A延伸到并离开砧座210A内的模制孔228A时,由于金属轴216A的附接构件(被遮挡)与砧座轴218A的接纳构件(被遮挡)配合,金属轴216A可拆卸地连接到砧座轴218A。在其他实施例中,制造过程可以变化。
如图11所示,往复式砧座调节杆114的接合构件244利用搭扣配合连接可拆卸地连接到金属轴216A的近端槽236A内,其中搭扣配合连接将金属轴216A和附接的砧座210A通过往复式砧座调节杆114可操作地连接到砧座控制构件120。在其他实施例中,往复式砧座调节杆114的接合构件244可以利用其他附接机构附接到金属轴216A。伸展槽240A允许金属轴216A的末端238A在连接到往复式砧座调节杆114的接合构件244的过程中伸展。在将圆形缝合器械100在患者身上使用之后,通过将金属轴216A的附接构件(被遮挡)从砧座轴218A的接纳构件(被遮挡)上分离,可以从砧座210A上移除金属轴216A,可以丢弃砧座210A,可以对金属轴216A消毒,并且可以利用上述相同过程将金属轴216A附接到新砧座,以允许金属轴216A与新砧座和新钉仓组件组合在另一个患者身上重复使用。
如图10-11所示,砧座轴210A包括在模制砧座210A时由于模具而成型的对齐表面246A。对齐表面246A包括设置成平行于砧座轴218A的纵向轴线248A的至少一个花键。对齐表面246A沿着砧座轴218A的环形外表面252A从砧座轴218A的顶部250A延伸到砧座轴218A的底部254A。砧座组件112A的金属轴216A不包括对齐表面。在其他实施例中,对齐表面246A可包括具有不同构型的任何数量或类型的对齐表面。
图12示出包括砧座210B、缝钉成型表面212B和环形分离式垫圈214B的砧座组件112B的另一个实施例的分解图。砧座210B为具有模制到砧座底表面220B的砧座轴218B的一件式聚合物模制部件。砧座210B由包含玻璃填充或碳填充尼龙的聚合物制成。在其他实施例中,砧座210B可以由类似的复合材料制成,该材料具有大于15,000psi的拉伸强度,以免在组织力的作用下过度弯曲。近端槽236B在砧座轴218B内延伸。砧座轴218B包括伸展槽240B。
砧座底表面220B被模制到缝钉成型表面212B。在其他实施例中,砧座底表面220B可使用不同的附接机构附接到缝钉成型表面212B。缝钉成型表面212B由包括奥氏体不锈钢的金属制成,其在形状上为环形,并且包括缝钉成型凹部。在其他实施例中,缝钉成型表面212B可由其他金属、不锈钢、铝的薄板或板制成。
环形分离式垫圈214B压力配合到砧座底表面220B的腔体222B内并邻近砧座底表面220B。在其他实施例中,环形分离式垫圈214B能够利用不同的附接机构附接到砧座底表面220B的腔体222B内。环形分离式垫圈214B由包括ABS(丙烯腈-丁二烯-苯乙烯)的塑料制成。在其他实施例中,环形分离式垫圈214B可由不同材料制成。
在制造砧座组件112B时,缝钉成型表面212B被预制。然后,将预制缝钉成型表面212B插入注塑模具内。然后,利用模具在模具内形成砧座210B,以将砧座210B模制到缝钉成型表面212B。在模制过程中,砧座底表面220B成型并且模制到缝钉成型表面212B。同时,包括砧座杆附接部分的砧座轴218B被一体地模制到砧座底表面220B。然后,将环形分离式垫圈214B压力配合到模制砧座底表面220B的腔体222B内。在其他实施例中,制造过程可以变化。
如图13所示,往复式砧座调节杆114的接合构件244利用搭扣配合连接可拆卸地连接到砧座轴218B的近端槽236B内,其中搭扣配合连接将砧座210B的砧座轴218B通过往复式砧座调节杆114可操作地连接到砧座控制构件120。在其他实施例中,往复式砧座调节杆114的接合构件244可以利用其他附接机构附接到砧座轴218B。伸展槽240B允许砧座轴218B在连接到往复式砧座调节杆114的接合构件244的过程中伸展。在将圆形缝合器械100在患者身上使用之后,可以丢弃砧座210B,并且可以使用新砧座和圆形缝合器械100在不同患者身上进行另一个手术。
如图12-13所示,砧座轴218B包括在模制砧座210B时成型的对齐表面246B。对齐表面246B包括设置成平行于砧座轴218B的纵向轴线248B的至少一个花键。对齐表面246B沿着砧座轴218B的环形外表面252B从砧座轴218B的顶部250B延伸,并停在砧座轴218A的中部256B处,而不延伸到砧座轴218A的底部254B。在其他实施例中,对齐表面246B可包括具有不同构型的任何数量或类型的对齐表面。
图14示出流程图274,图中显示了制造砧座组件的方法的一个实施例。在步骤276中,将可由金属或其他材料制成的预制缝钉成型表面设置在模具内。在步骤278中,通过将砧座模制到模具内的预制缝钉成型表面来形成砧座组件,使得所模制的砧座具有从砧座底表面延伸的砧座轴。砧座可由聚合物(例如玻璃填充或碳填充的尼龙)模制成一件式。在其他实施例中,砧座可由其他材料模制而成。在一个实施例中,步骤278还可包括将砧座轴模制成包括具有对齐花键的至少一个对齐表面或另一类型的对齐表面。在另一个实施例中,步骤278还可包括模制砧座组件,从而将砧座轴模制到在步骤276中设置在模具内的可由金属或其他材料制成的预制轴。在又一个实施例中,在后续步骤中,可以在模制砧座之后,将可由金属或其他材料制成的预制轴附接到模制砧座组件的砧座轴。在步骤280中,利用压力配合或其他附接机构将分离式垫圈附接到模制的砧座组件的砧座底表面。分离式垫圈可以是环形或另一种形状,可由包括ABS(丙烯腈-丁二烯-苯乙烯)的塑料制成,或者可由其他类型的材料制成。在其他实施例中,该方法的一个或多个步骤可以变化。
本公开的一个或多个实施例可以解决与此前砧座组件相关的一个或多个问题。例如,利用本公开的一个或多个实施例可以提供一种砧座组件,该砧座组件可以用现有砧座组件的三分之一的成本制造。
如图1-3所示,圆形缝合器械100包括柄部116、往复式砧座调节杆114、击发杆282、载体盖284、与柄部116可拆卸地相连的轴组件106、钉仓组件108、以及与往复式砧座调节杆114可拆卸地相连的砧座组件112。柄部116形成接纳击发杆282和往复式砧座调节杆114的腔体118。往复式砧座调节杆114具有在往复式砧座调节杆114的末端242处的接合构件244和带螺纹调节构件286,带螺纹调节构件286在往复式砧座调节杆114的近端处与砧座控制构件120可拆卸地相连。
击发杆282用来将往复式砧座调节杆114稳定和固定在柄部116内。击发杆282形成一对接合槽288和290,并且在击发杆282远端处具有接合轴292。接合槽288和290优选地成型在击发杆282的相对侧。击发扳机122包括上端294,上端294与接合槽288和290接合并将击发杆282和往复式砧座调节杆114可拆卸地固定在柄部116的腔体118内。作为另外一种选择,接合槽288和290可以替换成如本文所述的任何可拆卸连接。优选地,当把击发杆282和往复式砧座调节杆114放入腔体118内时,击发扳机122的上端294的各部分分别延伸到接合槽288和290中之一,并且将击发杆282和往复式砧座调节杆114可拆卸地固定在腔体118内。通过将击发杆282和往复式砧座调节杆114可拆卸地固定在腔体118内,接合槽288和290以及击发扳机122的上端294允许将击发杆282和往复式砧座调节杆114容易地放入和取出腔体118,从而容易地对它们进行维修或更换。腔体118的设计和上述部件的特征使得它们允许使用者在将其放入正确的位置和取向时进行清楚的观察。这种构造也防止使用者不正确地组装器械。
接合轴292形成开口296,通过该开口接纳往复式砧座调节杆114的末端242和接合构件244。通过接合轴292的开口296接纳往复式砧座调节杆114有助于使往复式砧座调节杆114在柄部116内居中并将往复式砧座调节杆114在钉仓组件108内对齐。钉仓组件108(参见图1和2)与轴组件106的远端(参见图3)可拆卸地相连。往复式砧座调节杆114的接合构件244的末端242在壳体110(参见图2)内延伸并通过,并且利用搭扣配合连接可拆卸地连接到砧座组件112的金属轴216的近端槽236(参见图2)。
参见图3,载体盖284在柄部116上方滑动,并将击发杆282和往复式砧座调节杆114的一部分覆盖在腔体118内。优选地,载体盖284形成开口298,通过该开口接纳柄部116的带螺纹部分132。开口298优选地为U形,并且在载体盖284的下侧300上形成,以使得当载体盖284在柄部116上方滑动时,载体盖284的邻接部分302压紧柄部116的一部分,这表明载体盖284已正确地设置在腔体118内的击发杆282和往复式砧座调节杆114的一部分上方。通过允许载体盖284在柄部116上方滑动,载体盖284将击发杆282和往复式砧座调节杆114保护在腔体118内,并允许容易地对它们进行维修或更换。
轴组件106在近端处与柄部116可拆卸地相连,并且在远端处与钉仓组件108(参见图1)可拆卸地相连。如本文所用,术语“可拆卸”是指第一部件或构件被设计成在不损坏另一部件或构件的情况下被脱开或分开。另外,如本文所用,术语“可拆卸地连接”或“可拆卸地固定”是指将第一构件以某种方式连接或固定到第二构件,其中这两个构件被设计成在不损坏任一构件的情况下彼此脱开或分开。这允许使用者将两个构件在不损坏的情况下彼此分开或脱开,以便使用者可以维修这两个构件。可拆卸地连接可以包括搭扣配合连接、摩擦接合连接(包括摩擦地彼此接合的构件)、螺纹连接、磁连接、或机械连接(例如钩环型紧固件)。
参见图3,优选地,轴组件106包括具有内螺纹304的连接螺母130,内螺纹304与柄部116上的螺纹部分132可拆卸地相连。作为另外一种选择,连接螺母130可以替换成如本文所述的任何可拆卸连接。一旦与柄部116可拆卸地相连,轴组件106就将载体盖284可拆卸地固定到柄部116,以允许容易地拆卸和维修圆形缝合器械100及其部件,例如,轴组件106、载体盖284、柄部116、击发杆282和往复式砧座调节杆114。
通过可拆卸地连接轴组件106与柄部116,通过将击发杆282和往复式砧座调节杆114可拆卸地固定在腔体118内,通过允许载体盖284在柄部116上方滑动,通过可拆卸地连接往复式砧座调节杆114与砧座控制构件120,通过可拆卸地连接轴组件106与柄部116,或者通过可拆卸地连接砧座组件112(参见图1)与往复式砧座调节杆114,圆形缝合器械100的组装和拆卸变得更加容易,并且允许维修和维护圆形缝合器械100的各种部件。
参照图15A和15B,在组装圆形缝合器械100过程中,砧座控制构件120与往复式砧座调节杆114可拆卸地相连。优选地,通过旋转带螺纹调节构件286上的砧座控制构件120,将砧座控制构件120在往复式砧座调节杆114的近端处与带螺纹调节构件286可拆卸地相连。典型地,逆时针旋转砧座控制构件120打开器械,顺时针旋转关闭器械。
接着,参照图16A和16B,砧座控制构件120的一部分和往复式砧座调节杆114的一部分可拆卸地固定在柄部116的腔体118内。优选地,腔体118形成缺口306,该缺口与砧座控制构件120的一部分配合,以便将砧座控制构件120和往复式砧座调节杆114可拆卸地固定在腔体118内。作为另外一种选择,可以颠倒缺口和凸起关系。一旦将往复式砧座调节杆114在位置118A处放入腔体118内,邻接腔体118的平行的平面壁114B和114C(参见图15B)就以某种方式相连,以便在允许纵向运动的同时防止往复式砧座调节杆114相对于柄部做旋转运动。
参照图17A、17B和17C,往复式砧座调节杆114的末端242和接合构件244通过击发杆282的接合轴292的开口296被接纳,接着,击发杆282的接合槽288、290被设置在击发扳机122的上端294上方然后将其包围,从而将击发杆282、往复式砧座调节杆114和砧座控制构件120可拆卸地固定在腔体118内。
参照图18A和18B,载体盖284接着在柄部116上方滑动并将击发杆282和往复式砧座调节杆114的一部分覆盖在腔体118内。优选地,柄部116的螺纹部分132通过开口298被接纳在载体盖284内,并且载体盖284被滑动,直到载体盖284的邻接部分302压紧柄部116的部分132a,表明已正确地设置载体盖284。
参照图19A、19B和19C,往复式砧座调节杆114被通过并放入轴组件106内,并且轴组件106与柄部116可拆卸地相连。优选地,轴组件106包括具有内螺纹304的连接螺母130,内螺纹304与柄部116上的螺纹部分132可拆卸地相连。轴组件106将载体盖284可拆卸地固定到柄部116。
接着,参照图2,钉仓组件108可拆卸地连接到轴组件106,并且往复式砧座调节杆114的末端242延伸通过在钉仓组件108内形成的中心轴。最后,砧座组件112通过往复式砧座调节杆114的接合构件244以及砧座组件112的金属轴216的近端槽236与往复式砧座调节杆114可拆卸地相连。
参照图20和21,在一个实施例中,提供了弯曲的圆形缝合器械100A,该器械包括具有壳体110A的钉仓组件108A、砧座组件112C(如上所述,其附接到砧座打开机构的弯曲的往复式砧座调节杆114A以防止意外移除砧座组件112C)、与柔性往复式砧座调节杆114A可拆卸地相连的弯曲的击发杆282A、与柄部116A可拆卸地相连的载体盖284A、与弯曲的往复式砧座调节杆114A通过带螺纹调节构件286A可拆卸地相连的控制构件120A、以及具有通过螺纹部分132A与柄部116A可拆卸地相连的连接螺母130A的人类工程学的弯曲轴组件106A。弯曲的圆形缝合器械100A包括弯曲部件,例如,柔性往复式砧座调节杆114A、弯曲击发杆282A和弯曲轴组件106A,以有助于插入哺乳动物的体腔内。
通过具有可拆卸地彼此相连的部件,圆形缝合器械100或弯曲的圆形缝合器械100A提供了一种具有开放结构的可重复使用的缝合器械,该结构使用具有U形开口298的载体盖284和具有U形开口298A的载体盖284A,以允许在大致横向的方向上组装附加部件(例如往复式砧座调节杆114、114A和轴组件106、106A)。横向组装使组装易于观察,并且缩短组装时间和增加组装与拆卸的便利性。因此,具有开放组装结构的圆形缝合器械100或弯曲的圆形缝合器械100A的组装所需时间常常少于1分钟。另外,开放结构允许在需要放置部件的地方存在连通的特征件。此外,通过提供彼此可拆卸地相连的部件,可以容易地组装或拆卸圆形缝合器械100或100A,以允许在使用之后对圆形缝合器械100或100A进行清洁和消毒。
参照图22-28,在一个实施例中,提供了一种圆形缝合器械100D,该器械包括具有壳体110D的钉仓组件108D、砧座组件112D(如上所述,其附接到砧座打开机构的往复式砧座调节杆114D以防止意外移除砧座组件112D)、与往复式砧座调节杆114D可拆卸地相连的击发杆282D、与柄部116D相连的载体盖284D、与往复式砧座调节杆114D相连的控制构件120D、以及具有通过螺纹部分132D与柄部116D相连的连接螺母130D的轴组件106D。优选地,圆形缝合器械100D为弯曲的圆形缝合器械(如器械100D所示),并且包括弯曲部件,例如,弯曲的往复式砧座调节杆114D、弯曲击发杆282D和人类工程学弯曲轴组件106D,以有助于插入哺乳动物的体腔内。然而,圆形缝合器械100D不必是弯曲的圆形缝合器械(如圆形缝合器械100D所示),也可以是任何类型的圆形缝合器械,例如相对较直的圆形缝合器械(如圆形缝合器械100所示),并且具有相对较直的部件,例如,相对较直的往复式砧座调节杆114D、相对较直的击发杆282D和相对较直的轴组件106D。
往复式砧座调节杆114D包括在往复式砧座调节杆114D的末端242D处的第一接合构件244D和在往复式砧座调节杆114D的基部402D处的带螺纹调节构件286D。优选地,往复式砧座调节杆114D包括在一端处的基部402D、在相对端处的接合构件244D、以及柔性张紧带400D,张紧带400D可以是柔性和弯曲的,并且将基部402D与接合构件244D相连。参照图22和23,击发杆282D在第一端430D处与击发扳机122D活动连接,并且在第二端432D处通过第二接合构件416D与钉仓组件108D活动连接。参照图28,击发杆282D形成第一接合表面406D,第一接合表面406D面对在往复式砧座调节杆114D上形成的相应的第二接合表面408D。优选地,张紧带400D形成第二接合表面408D,第二接合表面408D面对击发杆282D上的第一接合表面406D。
圆形缝合器械100D还包括摩擦减小构件420D,摩擦减小构件420D位于第一接合表面406D和第二接合表面408D之间,以减小往复式砧座调节杆114D和击发杆282D之间的摩擦。当柄部116D接合击发扳机122D并且击发扳机122D击发时,往复式砧座调节杆114D和击发杆282D之间发生运动,导致击发杆282D朝钉仓组件108D运动并与之接合,并且从钉仓组件108D中发射缝钉。当启动控制构件120D时,在往复式砧座调节杆114D和击发杆282D之间也发生运动,导致往复式砧座调节杆114D和连接到往复式砧座调节杆114D的末端242D的砧座组件112D朝向或远离钉仓组件108D地运动,以便调节钉仓组件108D和砧座组件112D之间的距离。往复式砧座调节杆114D和击发杆282D之间的任一种运动都导致往复式砧座调节杆114D与击发杆282D滑动接合,并且在往复式砧座调节杆114D和击发杆282D之间产生摩擦。如本文所用,术语“滑动接合”是指一表面在第二表面上方运动,同时在这两个表面之间保持平滑的连续接触。在弯曲的圆形缝合器械100D内,往复式砧座调节杆114D和击发杆282D之间的摩擦通常可以比相对较直的圆形缝合器械100高20-40%。在一个实施例中,圆形缝合器械100D的构型使得张紧带400D在击发杆282D上施加接触力,从而增加击发杆282D和往复式砧座调节杆114D之间的摩擦。通过在第一接合表面406D和第二接合表面408D之间设置摩擦减小构件420D,可以减小往复式砧座调节杆114D和击发杆282D之间的摩擦。也存在其他区域,在这些区域,在击发器械过程中在击发杆282D和柄部116D的其他部分之间产生摩擦力。通过将击发杆282D的凹槽288D和290D内的表面设置成预定的角度,可以减小这些摩擦力。如图38A所示,倾斜表面288F可以取向为偏离竖直方向5度至15度。这导致推动击发杆282D的力减小10-20%。
摩擦减小构件420D可以是可用来减小两构件之间(例如往复式砧座调节杆114D和击发杆282D之间)的摩擦的任何机械装置或化学合成物。具体地,摩擦减小构件420D在两构件之间提供了减小的摩擦系数μ减小,该值小于当两构件之间没有摩擦减小构件时两构件之间存在的正常摩擦系数μ正常。优选地,摩擦减小构件420D提供了减小的摩擦系数μ减小,该值比两构件之间存在的正常摩擦系数μ正常小至少20%,还更优选地小至少40%。
用于摩擦减小构件420D的化学合成物可包括:固体涂料(包括石墨)或聚合物涂料(例如特氟隆)。用于摩擦减小构件420D的化学合成物可以作为粘合到第一接合表面406D和第二接合表面408D中的一者或两者的涂层施加。用于摩擦减小构件420D的化学合成物也可以作为涂层施加,以使两接合表面406D和408D之间捕集的中间部件自由运动。用于摩擦减小构件420D的机械装置包括可减小一对表面之间的摩擦的任何机械装置,例如滚珠或滚子轴承。摩擦减小构件420D可以与往复式砧座调节杆114D和击发杆282D中的一者或两者相连。摩擦减小构件402D设计成在清洁和维修柄部以重复使用的过程中不会擦掉或降解。
参照图25-27,在一个实施例中,摩擦减小构件420D包括辊404D,辊404D利用销412D与击发杆282D相连,并且设置在成形于击发杆282D中的腔体410D内。优选地,销412D设置在通过击发杆282D形成的孔414D内。优选地,不止一个辊404D与击发杆282D相连,例如三个辊404D。在一个实施例中,孔414D形成圆形开口,通过该开口设置销412D,如图26所示,使得销412D可小幅运动。在一个实施例中,孔414D形成大致椭圆形的开口,销412D通过该开口设置并可以侧向运动,如图28所示,使得销412D朝向或远离击发杆282D的末端430D、432D中任一者的侧向运动比销412D的上下运动(不朝向或远离击发杆282D的末端430D、432D中任一者)幅度更大,以允许比此前的实施例更大的自由度。
图29示出图4的圆形缝合器械100的钉仓组件108的环形刀片126的透视图。如图29所示,环形刀片126包括环形刀刃192和分离式垫圈附接构件308。具有环形刀刃192和分离式垫圈附接构件308的环形刀片126由金属(例如不锈钢)制成。在其他实施例中,环形刀片126可由硬度足够进行切割的任何材料制成。分离式垫圈附接构件308包括多个间隔开的分离式垫圈保持倒钩,这些倒钩在邻近刀刃192的环形刀片126的位置310处延伸。分离式垫圈附接构件308相对于刀刃192以非平行角度312向内延伸。非平行角度312可以在56至60度的范围内。在其他实施例中,非平行角度312可以在30至60度的范围内。在另一些实施例中,分离式垫圈附接构件308可以相对于环形刀片126在材料、数量、形状、尺寸、位置、方向或构型上变化。例如,在其他实施例中,分离式垫圈附接构件308可包括按扣、压痕或其他类型的附接构件。
图6示出圆形缝合器械100的缝钉重装载组件102的砧座组件112的砧座底表面220,该表面相对于壳体110处于打开位置且与之分离,并且缝钉驱动器156和附接的环形刀片126处于回缩到壳体110内的预击发位置。环形分离式垫圈214压力配合到砧座210的砧座底表面220的腔体222内。利用钩316在设置在砧座底表面220的腔体222内的环形分离式垫圈214的顶部318上附接着保护构件314。
图30示出附接到保护构件314的环形分离式垫圈214的近距离视图。保护构件314包括由红色聚碳酸酯制成的环形保护帽。在其他实施例中,保护构件314可以在材料、数量、形状、尺寸、位置、颜色或构型上变化,并且可以使用不同的附接机构附接到环形分离式垫圈214。在另一些实施例中,可以不使用保护构件314,并且环形分离式垫圈214可以在没有保护构件314的情况下压力配合到砧座底表面220的腔体222内。
图7显示,砧座组件112的砧座底表面220已相对于壳体110运动到与之相邻的关闭位置,并且缝钉驱动器156和附接的环形刀片126仍然处于回缩到与环形分离式垫圈214间隔开的壳体110内的预击发位置。在该预击发位置,缝钉驱动器156的柔性制动构件178可拆卸地连接到壳体110的制动凸耳180,这种连接防止缝钉驱动器156在施加预定量的力之前运动。在其他实施例中,柔性制动构件178和制动凸耳180可包括不同类型的配合构件。
图31示出缝钉驱动器156和附接的环形刀片126已被击发,使缝钉驱动器156相对于壳体110从预击发位置运动到已击发位置,在该位置处,环形刀片126的刀刃192进入并切割环形分离式垫圈214,同时砧座组件112的砧座底表面220处于关闭位置。在击发过程中,缝钉驱动器156的柔性制动构件178从壳体110的制动凸耳180释放,以允许缝钉驱动器156经过相对于壳体110的某个点320。
图32示出切割环形分离式垫圈214的图31的环形刀片126的刀刃192的近距离视图。刀刃192切割设置在环形分离式垫圈214间隔开的壁322和324之间的腹板320。当发生这种情况时,分离式垫圈附接构件308固定地附接到环形分离式垫圈214的其中一个间隔开的壁322,用保护构件314(参见图31)将环形刀片126锁定到环形分离式垫圈214,其中保护构件314仍然附接到设置在砧座底表面220的腔体222内的环形分离式垫圈214的顶部318(参见图31)。
图33显示,在缝钉驱动器156和附接的环形刀片126被击发以切割环形分离式垫圈214之后,砧座组件112的砧座底表面220已返回远离壳体110的打开位置。环形分离式垫圈214仍然由于环形分离式垫圈附接构件308而在环形刀片126上方锁定位置,并且保护构件314仍然附接到环形分离式垫圈214的顶部318并用作在环形刀片126的刀刃192上方的保护性屏障。保护构件314防止环形刀片126的刀刃192在环形刀片126已经击发之后发生意外切割。环形分离式垫圈214或保护构件314中的至少一者包括视觉指示器326,该标记作为防范措施指示缝钉驱动器156和附接的环形刀片126已被击发。视觉指示器326具有与圆形缝合器械100的壳体110的第二颜色不同的第一颜色。在其他实施例中,视觉指示器326可包括在视觉上指示缝钉驱动器156和附接的环形刀片126被击发时刻的任何类型的视觉指示器。在另一个实施例中,只有被切割的环形分离式垫圈214的内部和视觉指示器326仍然附接到环形刀片126。被切割的环形分离式垫圈214的外部在打开器械之后仍然附接到砧座底表面220。
图34显示,在缝钉驱动器156和附接的环形刀片126被击发以切割环形分离式垫圈214之后,已从圆形缝合器械100上移除图33的砧座组件112的砧座210,剩下的环形分离式垫圈214和保护构件314则由于垫圈附接构件308而仍然附接到环形刀片126。保护构件314继续保护环形刀片126的刀刃192,以防止其在缝钉驱动器156和附接的环形刀片126已被击发之后发生意外切割。此外,视觉指示器326继续指示缝钉驱动器156和附接的环形刀片126已被击发。
图35示出试图附接到图34的圆形缝合器械100的新砧座210C。如图36所示,附接到环形分离式垫圈214(其与击发的环形刀片126附接)的保护构件314妨碍新砧座210C,使其不能附接到圆形缝合器械100。如图35所示,这是由于保护构件314的直径328大于新环形分离式垫圈332的内径330。即使保护构件314未附接到环形分离式垫圈214,环形分离式垫圈214仍然会妨碍新砧座210C,使其不能附接到圆形缝合器械100,因为环形分离式垫圈214具有与新环形分离式垫圈332的内径330相同或更大的直径334。
为了再次使用图34的圆形缝合器械100,可以从圆形缝合器械100上移除图1-2所示缝钉重装载组件102,从而移除已击发的环形刀片126和附接的分离式垫圈214。在对圆形缝合器械100的未移除部分(例如图1的柄部116和其他未移除部件)进行消毒之后,在再次使用圆形缝合器械100之前,可以将另一个未使用的缝钉重装载组件(包括另一个未使用的环形刀片和另一个未使用的分离式垫圈)附接到已消毒的圆形缝合器械100的未移除部分。图37示出将刀片锁定到圆形缝合器械的分离式垫圈的方法340的一个实施例的流程图。在步骤342中,提供了一种圆形缝合器械。所提供的圆形缝合器械包括壳体、缝钉驱动器、砧座组件和刀片。缝钉驱动器可动地设置在壳体内。砧座组件包括附接到砧座底表面的分离式垫圈。刀片附接到缝钉驱动器。
在步骤344中,砧座组件从远离壳体的打开位置运动到邻近壳体的关闭位置。在步骤346中,缝钉驱动器从预击发位置运动到已击发位置,在预击发位置,刀片尚未切割分离式垫圈,并且刀片的分离式垫圈附接构件尚未附接到分离式垫圈;在已击发位置,刀片切割分离式垫圈,并且刀片的分离式垫圈附接构件固定地附接到分离式垫圈。分离式垫圈附接构件可包括以非平行角度从刀片延伸到刀片的刀刃的至少一个分离式垫圈保持倒钧。非平行角度可以在56至60度的范围内。在其他实施例中,非平行角度可以在30至60度的范围内。在另一些实施例中,分离式垫圈附接构件可以变化。在一个实施例中,步骤346可包括刀片切割分离式垫圈的腹板,以及该至少一个分离式垫圈保持倒钩固定地附接到分离式垫圈的其中一个间隔开的壁。
在可选步骤348中,可能发生下列一种或多种情况:分离式垫圈可能妨碍圆形缝合器械的一个或多个部件,使刀片不能回缩到壳体内以再次使用;分离式垫圈或附接到分离式垫圈的保护构件可以用作刀片的保护性屏障;或者分离式垫圈或附接到分离式垫圈的另一个构件的视觉指示器可以在视觉上指示缝钉驱动器已被击发。
在可选步骤350中,可以继续下列步骤:可以从圆形缝合器械上移除缝钉重装载组件,从而移除用过的刀片和分离式垫圈;可以对圆形缝合器械的未移除部分进行消毒;并且可以在再次使用圆形缝合器械之前,将未使用的缝钉重装载组件(包括未使用的刀片和未使用的分离式垫圈)附接到圆形缝合器械。在其他实施例中,方法340的一个或多个步骤可以变化。
本公开的一个或多个实施例可以导致下列任何一种结果:防止已击发的圆形缝合器械的用过的刀片在另一个手术中意外地再次使用,从而提高了洁净度和安全性;防止已击发的圆形缝合器械的用过的刀片进行意外切割;防止圆形缝合器械不击发;或者另一种有益效果。
图38-46示出图1和2的实施例的圆形缝合器械100的各种视图,并且显示了各种状态的锁紧装置352,该装置可用于本公开的任何实施例,以防止击发扳机122和对应的缝钉驱动器156不击发。图38-40示出设置在击发区以外且远离壳体110的打开位置的砧座组件112的各种视图,其中击发扳机122和间接地受影响的缝钉驱动器156在预击发位置处于锁定状态。当砧座组件112设置在击发区以外且远离壳体110的打开位置时,利用附接的往复式砧座调节杆114和砧座控制构件120,将砧座底表面220设置成远离缝钉导向器148的末端的距离354在0.100至3.0英寸的范围内。在该预击发位置,往复式砧座调节杆114的带螺纹端286被设置在砧座控制构件120的配合带螺纹轴360的内部358处及其内,并且被设置成与砧座控制构件120的配合带螺纹轴360的末端362分离。
击发扳机122的凸缘364紧靠往复式砧座调节杆114的第一部分366,该第一部分用作锁紧装置352并阻挡和防止击发扳机122在方向124上旋转。往复式砧座调节杆114的第二部分370被设置成与凸缘364分离。凸缘364包括相对的壁372和374,它们被设置成相隔0.190英寸的距离376。往复式砧座调节杆114的第一部分366的宽度378为0.290英寸。往复式砧座调节杆114的第二部分370的宽度380(参见图43)为0.170英寸。由于第一部分366的宽度378大于凸缘364的相对的壁372和374之间的距离376,从而防止击发扳机122在方向124上旋转。
击发扳机122的上端294配合在击发杆282的接合槽288和290(参见图3)中。击发扳机122的上端294包括相对的表面294A和294B,它们被设置成相隔0.574英寸的距离382。相对的表面294A和294B之间的距离382大于第一部分366的宽度378,这允许相对的表面294A和294B经过第一部分366并进入接合槽288和290。击发杆282的末端384被设置成与缝钉驱动器156的末端386分离。由于往复式砧座调节杆114的第一部分366阻止击发扳机122在方向124上旋转,击发杆282的末端384(其配合到击发扳机122)仍然设置在与缝钉驱动器156的末端386分离的位置处,从而将缝钉驱动器156保持在预击发的锁定状态。
图41-43示出设置在击发区内邻近壳体110的关闭位置的砧座组件112的各种视图,其中击发扳机122和间接地受影响的缝钉驱动器156在准备击发的解锁状态,但仍然在如图38-40所示的相同预击发位置。当砧座组件112设置在击发区内邻近壳体110的关闭位置时,利用附接的往复式砧座调节杆114和砧座控制构件120,将砧座底表面220设置成远离缝钉导向器148的末端的距离388在0.06至0.100英寸的范围内。砧座控制构件120已经旋转,使得往复式砧座调节杆114的带螺纹端286在远离砧座控制构件120的配合带螺纹轴360的内部358的方向390上朝砧座控制构件120的配合带螺纹轴360的末端362运动并运动到该末端。由于这种运动,往复式砧座调节杆114的第一部分366在方向390上运动而被设置成与凸缘364的相对的壁372和374分离,使得第一部分366不再妨碍凸缘364。往复式砧座调节杆114的第二部分370也在方向390上从远离凸缘364的位置运动到设置在凸缘364上方的位置。
由于第二部分370的宽度380小于凸缘364的相对的壁372和374之间的距离376,击发扳机122此时可以自由击发,而不紧靠相邻的第二部分370。击发扳机122的上端294的相对的表面294A和294B仍然配合在击发杆282的接合槽288和290(参见图3)内。由于击发扳机122还没有在方向124上旋转,并且虽然解锁,但仍然在预击发位置,击发扳机122没有运动配合的击发杆282,并且击发杆282的末端384仍然被设置成与缝钉驱动器156的末端386分离,使得缝钉驱动器156处于其未击发但准备击发的位置。
图44-46示出设置在击发范围内邻近壳体110的关闭位置的砧座组件112的各种视图,其中击发扳机122已经在方向124上旋转而使击发扳机122和间接地受影响的缝钉驱动器156击发。击发扳机122允许被击发,因为往复式砧座调节杆114的第一部分366此前在方向390上运动而被设置成与凸缘364分离,使得第一部分366不再妨碍凸缘364,并且往复式砧座调节杆114的第二部分370的宽度380小于凸缘364的相对的壁372和374之间的距离376,这允许击发扳机122在不受第二部分370影响的情况下被击发。
在击发扳机122的击发过程中,当击发扳机122在方向124上旋转时,击发扳机122的上端294的相对的表面294A和294B紧靠击发杆282相应的配合的接合槽288和290(参见图3)在方向392上运动,从而迫使击发杆282也在方向392上运动。这种运动使得击发杆282的末端384紧靠缝钉驱动器156的末端386,从而迫使缝钉驱动器156也被击发和在方向392上运动。在缝钉驱动器156的这种击发过程中,缝钉驱动器156的运动将缝钉104(参见图7和31)弹射出环状缝钉保持器148(参见图4-5、7和31),并且如前所述用附接到缝钉驱动器156的环形刀片126(参见图31)切割组织。
通过这种方式,锁紧装置352自动地防止击发扳机122和对应的缝钉驱动器156及缝钉104(参见图7和31)不击发,圆形缝合器械100的使用者不必手动操作锁紧装置。此外,每当砧座组件112处于打开位置时,锁紧装置352将击发扳机122和对应的缝钉驱动器156及缝钉104(参见图7和31)自动地锁定在预击发位置;每当砧座组件112处于关闭位置时,锁紧装置352将击发扳机122和对应的缝钉驱动器156及缝钉104(参见图7和31)自动地解锁。锁紧装置352以这种方式操作,而不论砧座组件112已经打开和关闭了多少次,也不论击发扳机122和对应的缝钉驱动器156及缝钉104(参见图7和31)是否已经击发。
图47A示出图1的圆形缝合器械的另一个实施例,其具有另一个锁紧装置352A,用来防止缝钉驱动器156在将缝钉重装载组件108(参见图2)组装到柄部116上(参见图2)并且砧座210处于打开位置时发生运动。在砧座210处于打开位置的情况下,往复式砧座调节杆114邻近柔性制动构件178的部分114E具有小于但尺寸上足够接近缝钉驱动器156的环形内轴194的孔196的宽度或直径196A的尺寸、宽度或直径401(参见图3B),以防止柔性制动构件178在砧座调节杆114的部分114E和内孔表面196B之间的距离400足够大,以至于从制动凸耳180偏置和脱离,继而防止缝钉驱动器156运动和击发。如图47B所示,当砧座210靠近关闭位置时,往复式砧座调节杆114邻近柔性制动构件178的更狭窄部分114F具有尺寸上足够小于缝钉驱动器156的环形内轴194的孔196的宽度或直径196A的尺寸、宽度或直径402(参见图3A),以允许柔性制动构件178在砧座调节杆114的部分114F和内孔表面196B之间有足够的距离400,以便从制动凸耳180偏置和脱离,继而允许缝钉驱动器156运动和击发。
本公开的说明书摘要用来让读者快速了解本技术公开的本质。应当理解,所提交的该说明书摘要不是为了解释或限制权利要求的范围或涵义。此外,在上述具体实施方式中可以看到,为了使本公开更为简明而将各个特征在各个实施例中组合在一起。本公开的方法不应理解为体现了这样的意图:受权利要求书保护的实施例要求比每项权利要求中所明确列举的更多的特征。相反,如以下权利要求书所反映的,本发明的主题在于少于本发明所公开的单个实施例的所有特征。因此,据此将以下权利要求书并入具体实施方式中,并且每项权利要求单独地作为受权利要求书保护的主题。虽然已经描述了本公开的多个实施例,但对于本领域的普通技术人员显而易见的是,在本公开的范围内也可以有其他实施例和实施方式。因此,本公开不受到除所附权利要求及其等同形式以外的限制。
Claims (9)
1.一种用于圆形缝合器械的砧座组件,包括:
一件式聚合物砧座,所述一件式聚合物砧座包括砧座底表面和从所述砧座底表面延伸的砧座轴;和
缝钉成型表面,所述缝钉成型表面附接到所述砧座底表面,
其中,所述砧座包括延伸通过所述砧座轴和所述砧座底表面的孔。
2.根据权利要求1所述的砧座组件,其中所述砧座轴包括至少一个对齐表面。
3.根据权利要求1所述的砧座组件,其中金属轴延伸通过所述孔。
4.根据权利要求3所述的砧座组件,其中所述金属轴的第一端伸出所述砧座底表面内的所述孔,并且紧靠所述砧座底表面的顶部,所述金属轴的第二端伸出所述砧座轴内的所述孔。
5.根据权利要求4所述的砧座组件,其中所述金属轴附接到所述一件式聚合物砧座。
6.根据权利要求1所述的砧座组件,还包括附接到所述砧座底表面的分离式垫圈。
7.一种用于圆形缝合器械的砧座组件,包括:
一件式聚合物砧座,所述一件式聚合物砧座包括砧座底表面和从所述砧座底表面延伸的砧座轴;和
缝钉成型表面,所述缝钉成型表面附接到所述砧座底表面,
其中,所述砧座轴包括延伸到并不延伸通过所述砧座底表面的所述砧座轴内的孔。
8.根据权利要求7所述的砧座组件,还包括延伸到所述砧座轴的所述孔内的金属轴。
9.根据权利要求8所述的砧座组件,其中所述金属轴附接到所述一件式聚合物砧座。
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