CN101507633B - 用于外科切割缝合器械的端部执行器闭合系统 - Google Patents

用于外科切割缝合器械的端部执行器闭合系统 Download PDF

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CN101507633B
CN101507633B CN2009100078414A CN200910007841A CN101507633B CN 101507633 B CN101507633 B CN 101507633B CN 2009100078414 A CN2009100078414 A CN 2009100078414A CN 200910007841 A CN200910007841 A CN 200910007841A CN 101507633 B CN101507633 B CN 101507633B
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anvil block
disposable loading
loading units
nail bin
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CN101507633A (zh
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B·W·史密斯
K·R·多尔
W·D·凯利
R·J·科拉塔
J·R·尤斯
C·J·沙伊布
F·E·谢尔顿四世
W·B·威森伯格二世
J·R·摩根
K·P·穆尔
M·H·兰西克
S·G·哈尔
R·J·坦圭
J·D·梅瑟利
G·C·罗伯特逊
A·M·兹沃林斯基
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B17/07207Surgical 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 the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0023Surgical instruments, devices or methods, e.g. tourniquets disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • A61B2017/00473Distal part, e.g. tip or head
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526Methods of manufacturing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/0725Stapler heads with settable gap between anvil and cartridge, e.g. for different staple heights at different shots
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical 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
    • A61B2017/07214Stapler heads
    • A61B2017/07285Stapler heads characterised by its cutter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft

Abstract

一种包括致动器的外科缝合器,其中致动器设置为,相对于一次性加载装置的远端被回缩,以及使砧座在打开位置和闭合位置之间旋转。致动器可包括凸轮,其中凸轮可包括弓形轮廓,该弓形轮廓具有设置为当砧座位于闭合位置时与砧座接触的顶点。在至少一个这样的实施方式中,在缝钉被排出之前,砧座可给软组织施加夹紧力,以防止(或至少抑制)软组织流出(或被“挤出”)一次性加载装置的远端。在各个实施方式中,手术缝合器可包括具有砧座的一次性加载装置,其中砧座可在打开、闭合和/或折叠位置之间移动,以有助于一次性加载装置插入通过套管。

Description

用于外科切割缝合器械的端部执行器闭合系统
技术领域
本申请涉及外科缝合装置,并且在多种实施方式中,该申请涉及一种关节运动机构,该机构用于内窥镜外科缝合装置,该缝合装置用于将多个外科紧固件连续应用到身体组织上并可以切割被固定的组织。
背景技术
在现有技术中已知的外科装置中,组织首先在相对的夹钳结构间被握持或夹钳,之后用外科紧固件结合在一起。在某些器械中,用刀片来切割已经被紧固件结合在一起的组织。该紧固件通常是外科缝钉的形式,但是也可以使用两部分的聚合物紧固件。
用于此目的的器械可以包括两个细长构件,它们分别用于捕获或夹钳组织。一般而言,该构件中的一个支撑钉仓,该钉仓装载了多个缝钉,这些缝钉排列成至少两个横向排,而另一个构件具有砧座,当缝钉从钉仓中被驱动时,该砧座限定了用于钉腿成型的表面。通常,该缝钉操作通过纵向穿过钉仓的凸轮连杆进行,该凸轮连杆根据缝钉推动器运动,从而将缝钉从钉仓中射出。刀片可以穿过缝钉排之间从而纵向切割和/或打开在缝钉排间被钉住的组织。该器械可以是如美国专利3,079,606和3,490,675所揭示的那样,这两篇专利的全部内容都通过引用的方式被并入本发明中。
之后的如美国专利3,499,591所揭示的缝钉将双排缝钉应用在切口的每侧上,该篇专利的全部内容也通过引用的方式被并入本发明中。该专利的方案通过提供一次性加载装置而完成,其中,凸轮连杆移动通过细长导向轨,该导向轨在两组带有错列缝钉的凹槽之间。缝钉驱动构件位于所述凹槽中,其定位方式使得其与纵向移动的凸轮构件接触,以实现缝钉从一次性加载装置的钉仓中射出。这些缝钉的其它实例在美国专利4,429,695和5,065,929中被揭示,这两篇专利的所有内容通过引用的方式被并入到本发明中。
如上所述的每个器械都被设计成用于常规的外科手术,其中外科医生在手术位点直接手动操作。然而,在内窥镜和腹腔镜手术中,手术通过较小的切口或狭小的套管进行,所述套管插入并穿过皮肤上的小创口。为了适合内窥镜和/或腹腔镜外科手术的特殊需要,开发了内窥镜外科缝合装置,例如美国专利5,040,715(Green等人)、5,307,976(Olson等人)、5,312,023(Green等人)、5,318,221(Green等人)、5,326,013(Green等人)和5,332,142(Robinson等人)所揭示的那样,上述这些专利的全部内容通过引用的方式并入本发明中。
许多现有腹腔镜直线型缝合装置被设置成只与一种尺寸的一次性加载装置和钉仓一起操作。例如,目前有多个不同型号的直线型缝合器用于施加平行排的缝钉,所述缝钉可以具有30mm、45mm和60mm的长度。因此,在一般的操作过程中,一个外科医生需要使用多种缝合器械以执行单个腹腔镜外科手术。这种操作增加了时间、复杂性以及与腹腔镜外科手术有关的整个成本。另外,相对于建造单个多用途的缝合器,设计以及制作多种尺寸的缝合器成本也更高。
在腹腔镜和/或内窥镜外科手术中提供一种能够用于多种不同尺寸的一次性加载装置的外科装置是十分有益的,其可以减少与该手术有关的整个成本。同样,如果该装置能够使用不同尺寸和不同目的的一次性装载装置完成多个任务也将是特别有益的,例如,可以进行缝合、夹钳、切割和/或关节运动。
发明内容
根据本发明,提供一种用于将多个紧固件依次应用到身体组织上并切割组织的外科缝合装置的改进。在各种实施方式中,该外科缝合装置包括手柄部、细长主体(或称轴)以及一次性(disposable,用后可弃型)加载装置,其中一次性加载装置可移除地连接到细长主体上。在至少一个实施方式中,该细长主体可以包括连接器部件,该连接器部件能够可操作地与一次性加载装置的连接器部件接合,从而当手柄部的扳机被开动时,该扳机能推进一次性加载装置中的驱动器以从所述一次性加载装置和/或切割组织中排出缝钉。但是,在以前的外科缝合装置中,一次性加载装置可能从细长主体分离,引起外科缝合器故障或导致手术不能进行。
在本发明的各种实施方式中,通过使用一种外科缝合器可以改善这个问题,该缝合器具有手柄、从手柄开始延伸的轴(其中所述轴限定了轴线)和一次性加载装置,该一次性加载装置与轴以横穿轴线的方向装配在一起。在至少一个实施方式中,一次性加载装置和轴的这种连接能够防止或者至少抑制一次性加载装置相对于外科器械轴向近侧和/或远侧的意外位移。在至少一个实施方式中,外科缝合器和/或一次性加载装置可以进一步包括套环,该套环被设置成与轴和/或一次性加载装置的部分螺纹接合。在各种实施方式中,一次性加载装置和/或细长主体可以包括棘爪组件,当一次性加载装置被装配到细长主体后该棘爪组件用来将该一次性加载装置握紧在其正确位置。
在一次性加载装置已被连接到外科缝合器后,该器械可以相对于患者的软组织定位。在各种情况下,外科缝合器可以包括砧座和钉仓,该砧座能够相对于钉仓旋转以针对软组织定位砧座和钉仓。在某些外科缝合器中,该砧座能够设置成当缝钉从钉仓中释放时在砧座和钉仓间夹紧软组织。在各种情况下,软组织的一部分可能从一次性加载装置的远端向外流动或移动,因而外科缝合器无法适当地处理该软组织。
在本发明的各种实施方式中,通过使用能夹紧软组织的外科缝合器可以改善这个问题,例如在缝钉从钉仓开始被排出之前夹紧软组织。在各种实施方式中,外科缝合器可以包括制动器,该制动器被设置成相对于一次性加载装置的远端缩进,这样该制动器能够可操作地与砧座接合以旋转砧座,使其处于张开位置或闭合位置。在至少一个实施方式中,该制动器可以包括凸轮,该凸轮可以包括具有一顶点的弓形轮廓,该顶点可以被设置成当砧座在闭合位置时与砧座接触。在至少一个这种实施方式中,该砧座能在所述缝钉被排出之前将夹紧力施加在软组织上,并防止或至少抑制软组织从一次性加载装置的远端向外流动或“挤出(milking)”。
在本发明的各种实施方式中,外科缝合器可以包括一次性加载装置,该一次性加载装置包括钉仓、砧座以及套管,其中该套管能可以被设置成相对于钉仓和砧座滑动。在至少一个实施方式中,该套管可以包括一通孔,凭借该通孔,套管可以滑过砧座和钉仓的至少一部分以将砧座保持在闭合位置。在至少一个这种实施方式中,该套管可以滑动入位(slide into position)以在缝钉被排出进入软组织前将夹紧力施加在软组织上。在各种实施方式中,外科缝合器可以包括舌状物,该舌状物设置成相对于钉仓和砧座滑动,其中该舌状物可以设置成与砧座接合并将砧座保持在闭合位置。在至少一个实施方式中,该舌状物可以被设置从而其在所述一次性加载装置的远端将力施加在砧座上,以防止或至少抑制软组织从远端向外挤出。
在砧座被移动到闭合位置后,驱动梁能够被推进到该一次性加载装置中以从中射出缝钉和/或切割软组织。在各种情况下,该砧座可以包括定位在其中的狭槽,该狭槽可以被设置成接受驱动梁的至少一部分。在使用中,该驱动梁能够将力施加在该砧座上,从而能使砧座有弹性地和/或塑性地变形,并以此实现将外科缝钉排出到软组织。在本发明的各种情况中,砧座可以包括第一构件,该第一构件具有用于使缝钉变形的缝钉袋,固定在第一构件上的第一覆盖板,以及固定在第一构件和第一覆盖板中的至少一个上的第二覆盖板,其中该第一和第二覆盖板可以被设置成支撑第一构件。在至少一个实施方式中,砧座可以包括插入第二构件中的第一构件,在此处该第二构件能被变形从而该第一构件能够被保持在第二构件中并支撑第二构件。在其它的各种实施方式中,该第一构件能被压配合到第二构件中。在至少一个实施方式中,作为上述的结果,砧座更利于被设置成抵挡住施加在其上的力并消除或至少减少砧座中不需要的偏斜。
在各种情况下,特别在内窥镜外科外科中,外科缝合器的至少一部分通过套管或套管针插入到在手术位点。通常,一次性加载装置的砧座在其被插入套管针之前被移入其闭合位置,然后在其穿过套管针之后再被打开。一些具有较大的砧座和/或钉仓的一次性加载装置可能不适合或不容易通过该套管针。在本发明揭示的一些实施方式中,外科缝合器可以包括具有砧座的一次性加载装置,该砧座可以在打开、闭合和/或坍塌位置间移动以利于将一次性加载装置插入通过套管针。更特别地,在至少一个实施方式中,砧座可以在闭合位置和折叠位置间移动,在闭合位置时,砧座与所述钉仓之间存在例如第一距离,而在折叠位置时,砧座更靠近钉仓,从而使得该一次性加载装置能更容易地插入通过套管针。
在该一次性加载装置被使用或消耗后,其可以从外科工具的细长主体中移除,而新的一次性加载装置可以与所述细长主体装配。此后,该外科工具被再次插入手术点以执行外科技术的其它步骤。但是,在不同的情况下,外科医生或其他临床医生可能会不清楚一次性加载装置是否已经在先前被消耗。在本发明的一些实施方式中,一次性加载装置可以包括闭锁构件,其可以防止或至少抑制已消耗的加载装置与外科器械的细长主体再次装配。
更具体地说,本发明涉及如下内容:
(1).一种用于外科缝合器的一次性加载装置,其包括:
钉仓承载件,其设置为可操作地支撑钉仓;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可旋转地安装,其中,所述砧座设置为在打开位置和闭合位置之间旋转,并且所述砧座包括近端和远端;
驱动部件,其可相对于所述钉仓承载件和所述砧座移动,其中所述驱动部件设置为被从所述砧座的近端推向所述砧座的远端,以将缝钉从钉仓中排出;以及
致动器,其设置为从所述远端回缩,其中所述致动器可操作地与所述砧座接合,以当所述致动器相对于所述远端被回缩时,使所述砧座在所述打开位置和所述闭合位置之间转动。
(2).如第(1)项所述的一次性加载装置,其特征在于,所述砧座可枢转地安装至所述钉仓承载件,所述致动器包括凸轮,所述砧座包括凹陷部,以及所述凸轮设置为与所述凹陷部接合并且使所述砧座旋转进所述闭合位置。
(3).如第(2)项所述的一次性加载装置,其特征在于,所述砧座和所述钉仓承载件设置为限定一个枢轴,所述砧座可围绕所述枢轴旋转,并且,所述钉仓承载件包括孔,其设置为允许所述凸轮的至少一部分穿入孔而延伸。
(4).如第(1)项所述的一次性加载装置,其特征在于,所述致动器包括凸轮,其中所述凸轮包括具有顶点的弓形轮廓,并且所述顶点设置为当所述砧座在所述闭合位置时与所述砧座接触。
(5).如第(1)项所述的一次性加载装置,其特征在于,所述致动器设置为可操作地与外科缝合器的控制杆耦合(couple),这样可以操作所述控制杆以将所述致动器回缩。
(6).如第(1)项所述的一次性加载装置,其特征在于,进一步包括所述钉仓。
(7).如第(6)项所述的一次性加载装置,其特征在于,所述钉仓包括仓面(deck surface),当所述砧座在其闭合位置时,所述砧座的远端比所述砧座的近端更接近于所述仓面。
(8).一种用于外科缝合器的一次性加载装置,其包括:
钉仓承载件,其设置为可操作地支撑钉仓;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可旋转地安装,所述砧座设置为在打开位置和闭合位置之间旋转,并且所述砧座包括近端和远端;以及
致动器,其可操作地与所述砧座接合,以当所述致动器从所述远端被回缩时,使所述砧座在所述打开位置和所述闭合位置之间转动,其中所述致动器包括凸轮,所述凸轮包括具有顶点的弓形轮廓,并且所述顶点设置为当所述砧座在所述闭合位置时与所述砧座接触。
(9).如第(8)项所述的一次性加载装置,其特征在于,所述弓形轮廓包括由弧线的半径形成的圆形部分。
(10).如第(8)项所述的一次性加载装置,其特征在于,所述致动器设置为可操作地与手术缝合器的控制杆耦合,这样可以操作所述控制杆以将所述致动器回缩。
(11).根据第(8)项所述的一次性加载装置,其中,进一步包括所述钉仓,其中所述钉仓包括储存于其中的至少一个缝钉。
(12).根据第(11)项所述的一次性加载装置,其中,所述钉仓包括仓面,当所述砧座在其闭合位置时,所述砧座的远端比所述砧座的近端更接近于所述仓面。
(13).一种用于手术缝合器的一次性加载装置,其包括:
钉仓承载件,其设置为可操作地支撑钉仓;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可旋转地安装,其中,所述砧座设置为在打开位置和闭合位置之间旋转,并且所述砧座和钉仓承载件设置为,当所述砧座在所述闭合位置时,所述砧座和钉仓承载件形成第一周缘;
驱动部件,其可相对于所述钉仓承载件和所述砧座移动,其中所述驱动部件设置为可操作地与所述砧座接合,并且将所述砧座从所述打开位置移进所述闭合位置;以及
致动器,其设置为可操作地与所述砧座接合并且使所述砧座向所述钉仓承载件位移,这样所述砧座和所述钉仓承载件形成比所述第一周缘小的第二周缘。
(14).根据第(13)项所述的一次性加载装置,其中,进一步包括所述钉仓,其中所述钉仓包括储存于其中的至少一个缝钉。
(15).根据第(14)项所述的一次性加载装置,其中,所述钉仓包括仓面,其中所述致动器设置为将所述砧座定位为抵住所述仓面。
(16).根据第(14)项所述的一次性加载装置,其中,所述砧座包括近端和远端,所述驱动部件设置为被从所述砧座的近端推向所述砧座的远端,以将缝钉从所述钉仓中排出,所述钉仓包括仓面,当所述砧座在其闭合位置时,所述砧座的远端比所述砧座的近端更接近于所述仓面。
(17).根据第(13)项所述的一次性加载装置,其中,进一步包括弹簧,其设置为使所述砧座在所述闭合位置和所述打开位置之间移动。
(18).根据第(13)项所述的一次性加载装置,其中,进一步包括弹簧,其设置为在所述致动器已经可操作地从所述砧座脱离之后,移动所述砧座使其远离所述钉仓。
(19).一种用于手术缝合器的一次性加载装置,其包括:
钉仓,其包括储存于其中的至少一个缝钉;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可移动地安装,其中,所述砧座设置为在打开位置和闭合位置之间旋转;
驱动部件,可相对于所述钉仓承载件和所述砧座移动,其中所述驱动部件设置为可操作地与所述砧座接合,并且将所述砧座从所述打开位置移进所述闭合位置;以及
致动器,其设置为可操作地与所述砧座接合并且将所述砧座移进折叠位置,当所述砧座在所述折叠位置时,所述砧座比当所述砧座在所述闭合位置时更接近于所述钉仓。
(20).根据第(19)项所述的一次性加载装置,其中,所述钉仓包括仓面,所述致动器设置为当所述砧座在所述折叠位置时,将所述砧座定位为抵住所述仓面。
(21).根据第(19)项所述的一次性加载装置,其中,所述砧座包括近端和远端,所述驱动部件设置为被从所述砧座的近端推向所述砧座的远端,以将缝钉从钉仓中排出,所述钉仓包括仓面,当所述砧座在其闭合位置时,所述砧座的远端比所述砧座的近端更接近于所述仓面。
(22).根据第(19)项所述的一次性加载装置,其中,进一步包括弹簧,其设置为使所述砧座在所述闭合位置和所述打开位置之间移动。
(23).根据第(19)项所述的一次性加载装置,其中,进一步包括弹簧,其设置为在所述致动器已经可操作地从所述砧座脱离之后,移动所述砧座使其远离所述钉仓。
附图说明
这里将参考附图描述多个优选的实施方式:
图1本发明公开的外科缝合装置优选实施例的示意图;
图2是图1所示的外科装置的俯视图;
图3是图1所示的外科装置的侧视图;
图4示图1所示的外科装置的手柄组件的分解示意图;
图5示图4所示的击发闭锁机构一部分的剖视图;
图6是外科装置的防翻转离合器的侧板的示意图;
图7是图1所示的防翻转离合器的放大示意图;
图8是在非制动位置将一次性加载装置移除后图1所示的外科缝合装置的侧剖视图;
图9是图1所示的外科缝合装置旋转构件、关节运动机构和细长主体的分解示意图;
图10图8中所标出部分细节的放大图;
图10A是图1所示的外科缝合装置的关节运动机构的传输构件和细长主体近端的示意图;
图10B是图8所标出区域细节的放大剖视图;
图10C是沿图8的剖线10c-10c的剖视图;
图11是图1所示外科缝合装置的关节运动机构的凸轮构件的示意图;
图12是图1所示的外科缝合装置的关节连结机构的凸轮构件的俯视图;
图12A是可与图1中外科缝合装置一起使用的非关节运动的一次性加载装置的示意图;
图12B是图1所示外科缝合装置优选的关节运动的一次性加载装置的示意图;
图13是图10中沿剖线13-13的剖视图;
图14是图10中沿剖线14-14的剖视图;
图15是图10中沿剖线15-15的剖视图;
图16是图8中所标出区域的放大图,以说明该区域的细节;
图17是图1所示外科缝合装置的挡板的侧视图;
图18是图1所示外科缝合装置的挡板的俯视图;
图19是可与图1中外科缝合装置一起使用的一次性加载装置的示意图;
图20是可与图1中外科缝合装置一起使用的一次性加载装置的另一个示意图;
图21是图1中外科缝合装置的工具组建的分解示意图;
图22是砧座组件远端的放大示意图,其图示了多个缝钉变形空穴;
图23是图1中外科缝合装置的钉仓的远端放大示意图;
图24是图23中沿线24-24的侧剖图;
图25是图21所示的钉仓的仰视图;
图26是图21中制动撬、推进块和紧固件的放大示意图;
图27是图19所示一次性加载装置的近端壳体部和安装组件的分解放大示意图;
图28是图19所示的一次性加载装置的安装组件的的放大示意图,用于安装在近端壳体部的远端部分;
图29是图19中将上端半壳体移出后的一次性加载装置中的近端壳体部和安装组件的放大示意图;
图30是图19中将上端半壳体移出后的一次性加载装置中的上端壳体部和安装组件的放大示意图;
图31是轴向驱动组件的分解示意图;
图32是图31所示的轴向驱动组件的放大示意图;
图33是图31中包含锁定装置的轴向驱动组件的近端放大示意图;
图34是图31所示的轴向驱动组件的远端放大示意图;
图35是图1所示的缝合装置的细长主体的远端放大示意图;
图36是图33所示的锁定装置的放大示意图;
图37是图27所示的一次性加载装置中的近端壳体部的下半壳体放大示意图;
图38是图20所示的一次性加载装置的侧剖图;
图39是图38所示的所标出区域的放大图;
图40是图1所示的外科缝合装置的示意图,与图19中从细长主体中分离出来的一次性加载装置一起使用;
图41是当图19中一次性加载装置与图1所示的外科缝合装置的细长主体连接期间的放大示意图;
图42是当图19中一次性加载装置与图1所示的外科缝合装置的细长主体连接期间的另一张放大示意图;
图43是沿图41中剖线43-43的剖视图;
图43A是当一次性加载装置插入外科缝合装置细长主体时,旋转把手、关节运动机构和传感机构的侧剖图;
图44是图42中沿剖线44-44的剖视图;
图45是图1的一次性加载装置远端的侧剖图,其带有定位在砧座和夹紧组件间的组织;
图46是手柄组件的侧剖图,其带有在制动位置的可动手柄;
图47是图46所示的所标出区域的放大图;
图48是图19中一次性加载装置的近端和图1中外科缝合装置中的细长主体的远端的剖视图,其中控制杆处于部分推进位置;
图49是图1所示的外和缝合装置中的工具组件的剖视图,其处于夹紧组织状态;
图50是图1中缝合装置的手柄组件在该装置夹紧冲程期间的剖视图;
图51是图1所示的缝合装置中的工具组件在该装置击发期间的远端侧剖图;
图52是图1所示的缝合装置中的工具组件在该装置击发后的远端侧剖图;
图53是该装置的手柄组件在回收制动杆期间的侧剖图;
图54是缝合装置的手柄组件在紧急释放按钮制动期间的侧剖图;
图55是外科缝合装置的关节运动机构的俯视图;
图56是图1所示的外科缝合装置的关节运动机构和旋转构件的侧剖图;
图57是缝合装置在制动期间细长主体、安装组件和工具组件的近端的俯视图;
图58是在工具组件在关节运动期间,外科缝合装置的示意图;
图59是在工具组件在关节运动和旋转期间,外科缝合装置的示意图;
图60是在关节运动前瞬间,一次性加载装置远端俯视图;
图61是缝合装置在关节运动期间细长主体、安装组件和工具组件的近端的俯视图;
图62是锁定装置回收期间,一次性加载装置一部分的局部剖视图;
图63是一次性加载装置一部分的局部剖视图,其锁定装置在锁定位置;
图64是外科缝合装置一个实施例的细长主体和一次性加载装置的局部示意图;
图65是外科缝合装置的实施例的示意图,其包括限定了轴线的细长主体和一次性加载装置;
图66是图65中一次性加载装置的连接器部和图65中细长主体的连接器部的示意图;
图67是图66中连接器部又一个示意图,其一次性加载装置的附加组件已经被移出;
图68是图66的连接器部的剖视透视图,该连接器部组合在一起并通过螺纹环管被保持在位置中;
图69是图66的连接器部和图68中的螺纹环管的剖视主视图;
图70是一次性加载装置的连接器部的剖视图,该一次性加载装置被装配到外科缝合装置另一实施例的细长主体的连接部;
图71是图70的连接器部的详细视图;
图72是图70的外科缝合装置的剖视图,其沿图71的剖线72-72;
图73是图70细长主体制动器的详细视图;
图74是外科缝合装置的另一实施例的一次性加载装置的示意图;
图75是图74的一次性加载装置的分解图;
图76是图74的一次性加载装置的剖视图,该一次性加载装置包括在打开位置的砧座;
图76A是图74的一次性加载装置的详细视图,其图示了与砧座可操作地接合的制动器;
图77是图74的一次性加载装置的剖视图,其图示了在闭合位置的砧座;
图77A是图76A的一次性加载装置的制动器和砧座的详细视图;
图78是图74的一次性加载装置的平面图,其中一些组件已被移除;
图79是图74的一次性加载装置局部详细视图;
图80是图74的一次性加载装置的底部平面图;
图81是图74的一次性加载装置的钉仓承载件的剖视图;
图82是一次性加载装置的另一实施例的剖视主视图,其中一些组件已被移除,该一次性加载装置包括在打开位置的砧座;
图83是图82的一次性加载装置的详细视图,该一次性加载装置包括用于关闭砧座的制动器;
图84是图82的一次性加载装置另一剖视主视图,其图示了在闭合位置的砧座;
图85是图83的制动器和砧座的详细视图;
图86是一次性加载装置的另一实施例的砧座和制动器的示意图;
图87是一次性加载装置的另一可选实施例的制动器的示意图;
图88是一次性加载装置的另一实施例的驱动梁的示意图;
图89是图88的驱动梁的端视图;
图90是图88的驱动梁一部分的剖视图,该驱动梁定位在砧座通道中;
图91是外科缝合装置的一个实施例的一次性加载装置的示意图;
图92是图91的一次性加载装置的端视图;
图93是图91的一次性加载装置的剖视图;
图94是一次性加载装置的可选实施例的剖视图;
图95是一次性加载装置的另一可选实施例的剖视图;
图96是一次性加载装置的又一可选实施例的剖视图;
图97是一次性加载装置可选实施例的剖视图;
图98是一次性加载装置可选实施例的砧座组件的示意图,该砧座组件包括外部和插入部;
图99是图98的插入部的示意图;
图100是定位在图98的砧座组件外部部件内的插入物的剖视图;
图101是图98中砧座组件的剖视图,其图示了该组件被变形以将插入部保持于其中后的外部部分;
图102是一片管状材料的图示,其中已经将在虚线示出的部分移除;
图103是从图102的管状材料形成的砧座的剖视图;
图104是一次性加载装置可选择的实施例的砧座组件的剖视图,该砧座组件包括与外部部分压配合的内部部分;
图105是图104的内部部分的端视图;
图106是一次性加载装置可选择的实施例的砧座组件的剖视图,该砧座组件包括主体和与主体连接的支撑板;
图107是图106砧座主体的剖视图;
图108是图106的支撑板的剖视图;
图109是一次性加载装置的实施例的示意图,该一次性加载装置包括在闭合位置中的砧座和在收回位置的套管;
图110是图109一次性加载装置的示意图,其图示了套管在延伸位置中,以支撑砧座;
图111是一次性加载装置的可选实施例的示意图,该一次性加载装置包括在闭合位置中的砧座和在收回位置的舌状物;
图112是图111中的一次性加载装置的示意图,其图示了舌状物在延伸位置中,以支撑砧座;
图113是图111的一次性加载装置的剖视图;
图114是一次性加载装置的可选实施例的分解图;
图115是图114的一次性加载装置的剖视图,图示了打开位置的砧座部;
图116是图114的一次性加载装置的详细视图;
图117是图114的一次性加载装置的剖视图,其图示了闭合位置中的砧座;
图118是图116的一次性加载装置的详细视图;
图119是图114的一次性加载装置的剖视图,其图示了折叠位置中的砧座;
图120是图114的一次性加载装置的详细视图;
图121是图114的一次性加载装置的剖视图,其图示的折叠位置的砧座;
图122是图114的一次性加载装置的剖视图,其图示了砧座返回其闭合位置;
图123是一次性加载装置的可选实施例的示意图;
图124是图123的一次性加载装置的刀片锁定构件的示意图;
图125是图123的一次性加载装置的示意图,其中一些组件被移除,但带有外科缝合装置的细长主体的连接器部;
图126是图123的一次性加载装置的另一示意图;
图127是图123的一次性加载装置的另一示意图,其中细长主体连接器部的一些组件已经被移除;
图128是图123的一次性加载装置的示意图,其在外科装置的驱动梁被推进到一次性加载装置中之前,并且阻挡板与偏置弹簧相接合;
图129是图123的一次性加载装置的示意图,其在外科装置的驱动梁被推进到一次性加载装置中之后,并且阻挡板与偏置弹簧相脱离;
图130是图123的一次性加载装置的示意图,该装置从细长主体的连接器部中脱离,其图示了刀片锁定构件通过偏置弹簧偏置到禁止位置;
图131是一次性加载装置的可选实施例的示意图;
图132是图131的一次性加载装置的分解图,其图示了可移除的钉仓;
图133是图131的一次性加载装置的主视图;
图134是图131的一次性加载装置的端视图;以及
图135是图131的一次性加载装置的另一个端视图,其图示了打开位置中的砧座。
具体实施方式
本发明所公开的内窥镜外科缝合装置的优选实施方案将结合附图被详细描述,其中相同的附图标记指示了几个附图中相同或者相应的元件。本领域技术人员应该可以理解在此特别描述的方法和装置以及附图中所示的装置和方法都是非限制性的实施例,而本发明各种实施方案的保护范围完全通过权利要求来限定。联系一个实施例所说明和描述的特征也可以与其它实施例的特征结合。这样的修改和变化应被包含在本发明的范围之内。
在附图和下面的描述中,术语“近端”按照惯例是指缝合装置靠近操作者的一端,而术语远端是指该装置远离操作者的一端。
图1-3示出了本发明所公开的外科缝合装置的一个实施例,该装置被标记为10。简而言之,外科缝合装置10包括手柄组件12和细长主体14。一次性加载装置或DLU 16是可释放地紧固在细长主体14的远端。一次性加载装置16包括工具组件17,该工组组件17具有容纳多个外科缝钉的钉仓组件18和可移除地连接在钉仓组件18上的砧座组件20。一次性加载装置16被设计成可施加线性排的缝钉,缝钉的长度大约在30mm到60mm之间。具有其它长度缝钉的线性排的一次性加载装置也可以考虑,例如45mm。手柄组件12包括固定手柄构件22、可移动的手柄构件24和桶部26。优选地,旋转构件28安装在桶部26的前端以利于细长主体14相对于手柄组件12的旋转。关节运动杆30也优选安装在桶部26的前端并靠近旋转把手28以利于工具组件17的关节运动。一对回缩把手32沿桶部26可移动地定位以将外科缝合装置10回转到收回位置,这将在下面详细描述。
参考图4,手柄组件12包括壳体36,其优选从模制的半壳体36a和36b中形成,该半壳体形成了固定手柄构件22和手柄组件12的桶部26(见图1)。可移动的手柄构件24在半壳体36a和36b之间关于枢轴38被可枢转地支撑。偏置构件40,其优选为扭矩弹簧,将可移动的手柄24偏置远离固定手柄22。制动轴46在壳体36的桶部26中被支撑,其包括齿轮齿条48。具有齿条接合指43的驱动棘爪42关于枢轴44被可枢转地安装到可移动手柄24的一端,所述接合指43具有横向延伸翼43a和43b。偏置构件50,其同样优选为扭矩弹簧,被定位以促动驱动棘爪42的接合指43朝向制动轴46的齿轮齿条48。可移动手柄部24可以枢转以此将驱动棘爪42的接合指43移至与制动轴46的齿轮齿条48相接触,以在远端方向中线性推进制动轴。制动轴46的前端可旋转地接收控制杆52的近端49从而制动轴46的线性推进使得控制杆52也进行相应的线性推进。具有齿条接合构件55的锁定棘爪54在壳体36中围绕枢轴57可枢转地安装,并且其通过偏置构件56被偏置成朝向齿轮齿条48,所述偏置构件56也优选为扭矩弹簧。锁定棘爪54的接合构件55可移动至与齿轮齿条48接合以将制动轴46保持在纵向固定位置。
包括一对回缩把手32(见图1)的回缩机构58通过连接杆60与制动轴46的近端相连。连接杆60包括左和右接合部62a和62b以接收回缩把手32和中心部62c,该中心部的尺寸和结构被设计成能在一对纵向狭槽34a中进行平移,该纵向狭槽34a在制动轴46中形成并靠近制动轴的近端。释放板64与制动轴46可操作地联接在一起,其被安装来针对制动轴进行响应回缩把手32操作的移动。一对隔开的销66从制动轴46的横向表面起向外延伸以接合一对形成在释放板64中相应成角度的凸轮凹槽68。经过回缩把手32的向后运动,销66能够针对制动轴46和齿轮齿条48向下释放板64从而使得释放板64的底部沿着齿轮齿条48下方延伸,从而将驱动棘爪42的接合指43从齿轮齿条48中脱离。翻转狭槽70在释放板64的近端形成以容纳连接杆60的中心部62c,而细长狭槽34(见图1)被限定在手柄组件12的桶部26中以容纳连接杆60的纵向变化,此时回缩把手32被向下拉扯以回缩制动轴46,并进而回缩控制杆52。制动轴46通过弹簧72来偏置近端,该弹簧72通过连接器74紧固在连接杆部62的一端,而其另一端紧固在制动轴46上的柱体76处。
还是参考附图5,手柄组件12包括击发闭锁组件80,该组件包括活塞82和枢转锁定构件83。活塞82通过偏置弹簧84被偏置到一中心位置,其包括环状锥形凸轮表面85。活塞82的每个端部延伸通过壳体36(见图1)并靠近固定手柄22的上端。枢转锁定构件83在其远端两个半壳36a和36b之间围绕枢轴86被枢转连接,该枢转锁定构件83包括锁定表面88和近端延伸部90,该延伸部90具有形成在其中的狭槽89。锁定构件83通过弹簧92被逆时针偏置(如图4所示)以将锁定表面88移动到一位置以此毗邻制动轴46的远端,从而防止轴46的推进,进而防止了缝合装置10击发。环状锥形凸轮表面85被定位成延伸进入近端延伸部90的锥形狭槽89中。活塞82以任一相对各弹簧84的偏置的方向的横向移动将锥形凸轮表面85移至与锥形凹槽89的侧壁接合,从而围绕轴86以顺时针方向枢转锁定构件83,如图4所示,以此将阻挡表面88移入一位置从而允许制动轴46的推进并因此允许缝合装置10击发。阻挡表面88通过凹槽87被保持在此位置中,该凹槽接收凸轮表面85以在逆时针位置锁住锁定构件83。击发闭锁组件80的操作会在下面进一步描述。
参考附图4、6和7,手柄机构12还包括防反转离合器机构,该机构包括可旋转地安装在第一轴96上的第一齿轮94,和安装在第二轴100上的第二齿轮,和滑动安装在壳体36中的滑片102(图6和7)。滑片102包括细长狭槽104,该细长狭槽被设计和设置成能对于锁定棘爪枢轴57滑动定位;传动板106,该传动板被设置成与第二齿轮98的轮齿啮合;以及凸轮表面108。在收回位置中,滑片102的凸轮表面108与锁定棘爪54接合以防止锁定棘爪54与齿轮齿条48接合。制动轴46包括一套远端的轮齿110a,该轮齿与一套近端的轮齿110b隔开,轮齿110b定位成在制动轴46移动期间与制动轴46的第一齿轮94接合。当制动轴46通过绕枢轴38枢转可移动的手柄24而被推进时,远端轮齿110a在制动轴46上与第一齿轮94和第一轴96啮合并将使它们旋转。第一轴96通过弹簧离合器组件与第二轴100连接,从而第一轴96的旋转会使得第二轴100也相应地旋转。第二轴100的旋转使得在滑片102上与传动板106接合的第二齿轮98也相应地旋转,从而引起滑片102的线性推进。滑片102的线性推进受限于细长狭槽104的长度。当滑片推进了狭槽104的全长时,凸轮表面108将棘爪54释放从而该棘爪54移动至齿轮齿条48与其接合。制动轴46的继续推进最终将轮齿110b移动至传动板106与其接合。然而,由于滑片102在位置上纵向固定,因此该弹簧离合器受力释放,从而允许制动轴46继续向远端推进。
当制动轴46返回到收回位置时(如上所述,通过在近端拉扯回缩把手34),轮齿110b与第一齿轮94接合以反方向旋转第二齿轮98从而向近端拉回壳体36中的滑动件102。滑动件102的近端移动将凸轮表面108在锁定棘爪54与齿轮齿条48接合前推入棘爪54,以此促使锁定棘爪54位于允许制动轴46回缩的位置。
再次参考图4,手柄组件12包括紧急返回按钮112,该按钮关于枢转构件114枢转安装在壳体36中,该枢转构件114在半壳体36a和36b之间被支撑。返回按钮112包括外部定位构件116,该定位构件位于桶部26的近端。构件116关于枢转构件114可移动至与锁定棘爪54的近端接合,从而促使齿条接合构件55与齿轮齿条48分离,从而允许在缝合装置10击发冲程期间回缩制动轴46。如上所述,在制动轴46推进的夹紧部分中,滑片102将棘爪54与齿条48分离,因此返回按钮112的制动对于回缩制动轴46来说不是必要的。
图8示出了细长主体14与手柄组件12的相互连接。参考图8-10,壳体36包括环形通道117,该通道设置成接收形成在旋转构件28近端上的环形筋118,该旋转构件优选从模制的半壳28a和28b中形成。环形通道117和筋118允许旋转构件28与壳体36间的相对旋转。细长主体14包括内壳122和外壳124。内壳122尺寸设计为能被外壳124收纳于其中,该内壳包括内孔126(图8),该内孔126延伸通过内壳,其尺寸被设计为能滑动接收第一关节运动连接件123和控制杆52。内壳122和外壳124的近端分别包括一对直接相对的开孔130和128,这些开孔的尺寸被设计为能接收径向突起部132,该突起部形成在旋转构件28的远端上。突起部132和开口128和130与旋转构件28和细长主体14相互纵向地和旋转地固定不动。旋转把手28相对于手柄组件12转动,从而使细长主体相对于手柄组件12相应地转动。
关节运动机构120在旋转构件28上被支撑,其包括关节运动杆30、凸轮构件136、传递构件138和第一关节运动连接件123(图9)。关节运动杆30关于枢转构件140被可枢转地安装,其从旋转构件28中向外延伸并且其优选与旋转构件28一体成型。突出部142从关节运动杆30开始向下延伸以用于与凸轮构件136接合。
临时参考附图11和12,凸轮构件136包括壳体144,该壳体具有细长狭槽146和阶梯凸轮表面148,该细长狭槽延伸通过壳体的一侧,该阶梯凸轮表面在壳体的另一侧中形成。凸轮表面148的每个阶梯对应于缝合装置10的特定的关节运动度数。尽管所示出的是5个阶梯,但是也可以提供更多或更少的阶梯。细长狭槽146的结构被设计成能接收形成在关节运动杆30上的突出部142。壳体144包括远端阶梯部150和近端阶梯部152。近端阶梯部152包括凹槽154。
再次参考图8-10以及图13-15,平移构件138包括多个脊156,该脊被设计成能滑动地容纳在凹槽158中,该凹槽沿着旋转构件28的内壁形成。脊156和凹槽158间的接合防止了旋转构件28与平移构件138间的相对旋转,但其允许相对线性运动。平移构件138的远端包括臂部160,该臂部包括开口162,该开口被设计成能接收从关节运动连接部123的近端开始延伸的指形部164(见图10a)。销166具有壳体168,该壳体由无磨料材料构成,例如特氟纶,该销166被紧固到平移构件138中并将其尺寸设计为能容纳在阶梯凸轮表面148中。
在装配情况下,凸轮构件136的近端和远端的阶梯部150和152被定位在旋转构件28上成型的凸缘170和172的下方,以将凸轮构件136限制到相对缝合装置10的纵轴横向移动。当关节运动杆30围绕枢转构件140而被枢转时,凸轮构件136在旋转构件28上横向移动以将阶梯凸轮表面148相对于销166横向移动,迫使销166向近端或远端沿着阶梯凸轮表面148移动。由于销166被固定连接到平移构件138上,所以平移构件138向近端或远端移动,实现第一关节运动接合部123的相应近端或远端运动。
参考图8-10和16,一次性加载装置传感机构在缝合装置10中从细长主体14延伸入手柄组件12。该传感机构包括传感器管176,该传感器管在细长主体14的孔26中被滑动支撑。传感器管176的远端被定位成朝向细长主体14的远端,而传感器管176的近端通过一对突块180被紧固在传感器圆柱体176的远端中。传感连接件182的远端被紧固在传感器圆柱体178的近端中。传感连接件182(见图8a和8c)具有球端部184,该球端部与枢转锁定构件83上的凸轮表面83a接合。当一次性加载装置(未示出)被插入到细长主体14的远端时,该一次性加载装置接合传感器管176的远端177以向近端驱动传感器管176,从而向近端驱动传感器圆柱体178和传感器连接件182。传感器连接件182向近端的运动使得传感器连接件182的球端部184向远端移动凸轮表面83a,以使得锁定构件83能够在弹簧92的偏置下从允许缝合装置10击发的位置开始枢转到阻挡位置,其中阻挡构件83被定位为与制动轴46接合并防止外科缝合装置10击发。传感器连接件182和锁定构件83的作用是在一次性加载装置已经被紧固到细长主体14后,无需第一击发操作闭锁组件80就可以防止外科缝合装置10击发。需要注意的是,连接件182向近端的移动允许锁定构件83移动到其位置上,如图5所示。
参考图9-12,凸轮构件136包括凹槽154。锁定环184具有突块部186,该突块部被设计成能容纳在凹槽154中,该锁定环围绕着在控制片部分188和近端凸缘部190间的传感器圆柱体178来定位。定位在凸缘部190和锁定环184间的弹簧192促使锁定环在远端围绕传感器圆柱体178。当具有延伸插入片193的关节运动的一次性加载装置16b被插入到缝合装置10的细长主体14的远端时,插入片193使得控制片部188向近端移至与锁定环184接合,从而促动锁定环184的突块186至凸轮构件136的凹槽154的近端(见图12b)。当突块186定位在凹槽154的近端时,凸轮构件136能自由横向移动以实现缝合装置10的关节运动。非关节运动的一次性加载装置不具有延伸的插入片(见图12a)。因此,当非关节运动的一次性加载装置被插入到细长主体14时,传感器圆柱体178没有在近端被回缩足够的距离,从而从凹槽154开始移动突块186。因此,锁定环184的突出物186防止了凸轮构件136的横向移动,该锁定环定位在凹槽154中,而关节运动杆30在其中心位置处被锁定。
参考图16-18,细长主体14的远端包括控制杆锁定机构190,该锁定结构在一次性加载装置插入到细长主体14中时被激活。控制杆锁定机构190包括阻挡板192,该阻挡板被弹簧194向远端偏置,并且包括近端指形部189,该指形部具有成角度的凸轮表面195。半圆接合构件196被弹簧197朝控制杆52横向偏置。控制杆52包括环形凹槽199,该凹槽被设计成能接收结合构件196。阻挡板192可从与接合构件196分离的远端位置开始向位于接合构件196后方的近端位置移动。在近端位置处,接合构件196通过与阻挡板192接合来防止其从凹槽199中偏置。在一次性加载装置16(见图1)插入到细长主体14的远端期间,此插入过程将在下面被详细表述,阻挡板192的凸轮表面195在所述一次性加载装置16上被突块254(图30)接合,同时该一次性加载装置旋转至与细长主体14接合从而促使板192位于近端位置。定位在凹槽199中的接合构件196通过阻挡板192被保留在该凹槽中,而此时突块254接合凸轮表面195以防止控制杆52在组合时纵向移动。当一次性加载装置16完全针对细长主体14定位时,该一次性加载装置16近端的突块254穿入凸轮表面195,这将允许弹簧194将阻挡板192回转到其远端位置,从而允许控制杆52的纵向移动。需要注意的是当该一次性加载装置突块穿入凸轮表面195时,可以听到一个滴答声,这表示该一次性加载装置16被完全扣紧在细长主体14中。
参考图19和20,一次性加载装置16包括近端壳体部200,其适于与主体部14(图1)的远端可释放地接合。安装组件202被可枢转地紧固到壳体部200的远端,并且其被设计成能接收工具组件17的近端从而安装组件202围绕一垂直于壳体部200纵向轴的轴所作的枢转运动实现了工具组件17的关节运动。
参考图21-26,工具组件17优选包括砧座组件20和钉仓组件18。砧座组件20包括砧座部204,该砧座部具有多个缝钉变形凹陷(图22)和紧固在砧座部204顶部表面的盖板208以此限定出所述盖板与所述顶部表面间的空腔210(见图24)。在组织缝合装置10击发和夹紧操作期间,盖板208被用来防止组织夹持。空腔210的尺寸被设计成能接收轴向驱动组件212(见图27)的远端。纵向狭槽214延伸通过砧座部204以便将轴向驱动组件212的阻挡凸缘284穿过砧座空腔210。在砧座部204上形成的凸轮表面209被定位以与轴向驱动组件212接合,以便夹紧组织198。一对在砧座部204上形成的枢转构件211被定位在在承载件216中形成的狭槽213中以引导开口位置和夹紧位置间的砧座部。一对稳定构件215分别与在承载件216上形成的肩部217接合从而防止在凸轮表面209变形时砧座部204相对于钉仓220轴向滑动。
钉仓组件18包括承载件216,该承载件限定了细长支撑通道218。细长支撑通道218的尺寸和结构被设计成接收钉仓220。沿着钉仓220和细长支撑通道218形成的相应的接头222和狭槽224的作用是将钉仓220保持在支撑通道218中。一对形成在钉仓220上的支柱223被定位成搁在承载件216的侧壁上以进一步稳定在支撑通道218中的钉仓220。
钉仓220包括用于接收多个紧固件226和推进件228的保持槽225。多个隔开的纵向凹槽230延伸通过钉仓220以容纳制动撬234的直立凸轮楔232。中心纵向狭槽282沿着钉仓220的长度延伸以便刀刃280的穿过。在外科缝合器10的操作过程中,制动撬234平移通过钉仓220的纵向狭槽230以推进凸轮楔232连续地与推进件228接触,从而使得推进件228在狭槽224中垂直移动,并促使紧固件226从狭槽224进入砧座组件20的缝钉变形空腔206。
参考图27和28,安装组件202包括上安装部236和下安装部238。每个安装部包括在安装部每个侧边上的螺纹镗孔240,其尺寸被设计成能够接收用于将承载件216的近端紧固到镗孔中的螺栓242(见图21)。一对中枢定位的枢转构件244(见图21)在上安装部和下安装部之间通过一对连接构件246延伸,该连接构件与壳体部200的远端接合。每个连接构件246包括联锁的近端部248,该近端部被设计成可容纳于在壳体部200近端部中形成的凹槽250中,从而将安装组件202和壳体部200保持在与其相关的纵向固定位置中。
一次性加载装置16的壳体部200包括包含在外壳251中的上半壳体250和下半壳体252。上半壳体250的近端包括接合突块254,该接合突块用于与细长主体14和插入片193可释放地接合。突块254与主体14的远端一起形成了卡口式联结器,这会在下面被详细描述。半壳体250和252限定了用于滑动接收轴向驱动组件212的通道253。第二关节运动连接件256的尺寸设计成能被滑动地定位在狭槽258中,该狭槽在半壳体250和252之间形成。一对突起(blow out)板254定位于靠近壳体部200的远端,靠近轴向驱动组件212的远端,以防止驱动组件212在工具组件17关节运动时向外凸出。
参考图29-30,第二关节运动连接件256包括至少一个细长金属板。优选地,两个或者多个金属板堆积在一起以形成连接件256。关节运动连接件256的近端包括钩部258,该钩部设计成与第一关节运动连接件123接合(见图9),而该连接件的远端包括环260,其尺寸被设计成能与安装组件202上的突出物262接合。突出物262从枢轴244开始横向位移从而第二关节运动连接件256的线性运动使得安装组件202围绕枢轴244枢转,以使工具组件17关节运动。
参考图31-34,轴向驱动组件212包括细长驱动梁266,该梁包括远端工作头268和近端接合部件270。驱动梁266可以是单片材料的结构,或者优选为多片堆栈结构。接合部件270包括一对接合指270a和270b,它们的尺寸和结构被设计为能安装地(mountingly)接合一对形成在驱动构件272上的对应保持狭槽272a和272b。驱动构件272包括近端通道口274,该通道口被设计成在一次性加载装置16的近端与外科缝合装置10的细长主体14接合时可容纳控制杆52(见图35)的远端276。
驱动梁266的远端通过垂直支撑支柱278和邻接表面283来限定,该支柱支撑刀片280,该邻接表面在缝合过程中与制动撬234的中心部相接合。表面283基部的表面285被设计成可容纳支撑构件287,该支撑构件可延钉仓220的底部滑动定位。刀片280被定位以在制动撬234之后轻轻平移穿过钉仓220(图30)中的中心纵向狭槽282,以形成几排被缝合组织间的切口。阻挡凸缘284从垂直立柱278处向远端伸出并在其远端支撑起该圆柱形凸轮辊子286。凸轮辊子286的尺寸和结构设计成能在砧座体204上与凸轮表面209接合以夹紧砧座体204并紧贴人体组织。
还是参考图36-39,锁定装置288绕着枢轴290被枢转地紧固于驱动构件270。锁定装置288包括一对细长的滑道292和294,该滑道限定了通道296。网298连接了滑道292和294的一部分上表面,并且其结构和尺寸设计成能安装在细长狭槽298中,该狭槽在驱动构件270的远端位置形成在驱动梁266中。水平凸轮300和302分别从滑道292和294开始延伸,它们沿着下半壳体252内表面被容纳。如图42所示的最佳情况,扭矩弹簧304被定位于驱动构件270附近并接合了锁定装置288的水平凸轮300和302,从而将锁定装置288向边缘310上的下半壳体252进行一般向下的偏置。锁定装置288平移通过具有轴向驱动组件212的壳体部200。锁定装置288的操作将在下面被详细表述。
操作顺序
参考图40-44,为了使用缝合器械10,一次性加载装置16首先被紧固在细长主体14的远端。如上所述,缝合器械10可以与关节运动或非关节运动的一次性加载装置一起使用,这些一次性加载装置具有线性排的缝钉,缝钉的长度大约在30mm到60mm之间。为了将一次性加载装置16紧固到细长主体14上,控制杆52的远端276被插入到一次性加载装置16的插入片193中,而插入片193以图41中箭头“A”的方向纵向滑入细长主体14的远端,从而第二关节运动连接件256的钩部258滑入细长主体314的通道310中。每块突块254都被排列在细长主体14中的各自的通道(未示出)中。当钩部258与通道310的近端壁312接合时,一次性加载装置16以图41-44中箭头“B”所示的方向旋转以将第二关节运动连接件256的钩部258移至与第一关节运动连接件123的指形部164接合。突块254同样在主体14中的环形通道314中形成卡口式连接器。在加载装置16的旋转过程中,突块254接合阻挡板192的凸轮表面195(图41)从而在最初以图41和43中箭头“C”所示方向移动板192以此锁定控制杆52中凹槽199中的接合构件196,从而在一次性加载装置16被连接期间防止控制杆52的纵向移动。在旋转最终度数期间,突块254从凸轮表面195中释放出来以使得阻挡板192能从接合构件196后以图42和44中箭头“D”所示的方向移动,从而再次允许控制杆52的纵向移动。
参考图43和43a,当插入片193与传感器管176的远端接合时,一次性加载装置传感机构被制动。插入片193与传感器管176接合并在近端以图43中箭头“E”所示方向移动传感器管176。如上所述,传感器管176的近端移动实现了传感器圆柱体178和传感器连接件182以图43a中箭头“E ”所示方向所进行的近端移动,从而以图43a中箭头“Y”所示方向将锁定构件83从非阻挡位置逆时针枢转到阻挡制动轴46移动的位置。
参考图46-49,当一次性加载装置连接到缝合器械10时,工具组件17能够围绕组织320(图45)被定位。为了在砧座组件20和钉仓组件18间夹紧组织,可移动手柄24以图46中箭头“E”所示的方向抵抗扭矩弹簧40的偏置力移动,从而将驱动棘爪42移至于制动轴46上的肩部322相接合。肩部322和驱动棘爪42间的接合推进了制动轴46并因此在远端推进控制杆52。控制杆52在其远端处被连接到轴向驱动组件212(图48),该驱动组件包括驱动梁266,从而控制杆52的远端移动实现了驱动梁266以图48和49中箭头“F”所示方向所进行的远端移动,将凸轮辊子286移至与砧座部204上的凸轮表面209相接合,从而以图49中箭头“G”所示方向促动砧座部204。需要注意的是可移动手柄24的一个完全的冲程推进了制动轴46大约15mm,这对于在第一冲程期间夹紧组织而言是充分的,但不是对缝合器的击发操作而言。
如上所述,对于反转离合器机构而言,在可移动的手柄24的第一(夹紧)冲程期间,滑板102(图46)防止锁定棘爪54与齿轮齿条48接合。为了在手柄24释放后将制动轴46保持在其纵向位置,在锁定构件83上提供接合组件324(图47),以接合制动轴46上的肩部326并将制动轴46保持在其纵向位置中(见图47)。在将可移动手柄24释放后,一旦扭矩弹簧40将手柄24返回到远离固定手柄的位置,驱动棘爪42就移过齿条48。在此位置中,驱动棘爪42被促使与齿轮齿条48接合以将制动轴46保留在其纵向固定位置中。
为了启动缝合器,可移动手柄24被再次制动,也就是被移动通过另一个冲程。如上所述,缝合装置10能够容纳具有线性排的缝钉的一次性加载装置,缝钉的长度在大约在30mm到60mm之间。由于每个可移动手柄24的冲程优选为推进制动轴46移动15mm,并且一个冲程需要用来抓紧组织,所以该可移动手柄必须被(n+1)个冲程制动以将缝合器击发,其中n是与缝合器械10相连的一次性加载装置中的线性排缝钉的长度除以15mm。
参考图50,在击发缝合装置之前,击发闭锁组件80(图4)必须被制动以将锁定表面88从其阻挡位置(图47)移动到非阻挡位置。此操作通过按下活塞82来完成,以此将凸轮表面85移至与锁定构件83的狭槽89的侧壁接合从而以图50(也可见图5)中箭头“G”所示方向枢转锁定构件83。此后,可移动手柄24可以被制动一定数量的冲程在以向远端以图51和52中箭头“H”所示方向推进制动轴46,并进而推进制动杆52和驱动梁266,以此将制动撬234推进通过钉仓220以实现缝钉的射出。需要注意的是,在可移动手柄54的第一或夹紧冲程之后(在第二冲程期间),滑片102通过锁定棘爪54以使得扭矩弹簧56能够以图50中箭头“I”所示方向将锁定棘爪54移至与齿轮齿条48接合,从而将制动轴保持在其纵向位置中。
参考图53,为了在缝合器击发后回缩制动轴46并进而回缩控制杆52和驱动构件266,将回缩把手32(见图1)向近端拉扯并促动销66,从而以图53中箭头“J”方向移动释放板64,以此将驱动棘爪42从与其接合的齿条48中脱离出来。如上所述,对于防反转离合器机构,滑板102促使锁定棘爪54与齿轮齿条48(未示出)脱离从而在驱动棘爪42与齿条48脱离后,允许制动轴46向近端以箭头“L”所示的方向移动。
参考图54,为了在缝合装置击发之前回缩制动轴54,也就是当锁定棘爪正与齿轮齿条48接合时,紧急返回按钮112以图54箭头“Z”所示方向被按下以将锁定棘爪54与齿轮齿条48脱离。如上所述,回缩把手32(见图1)同样必须同时被向后拉,以从齿条48中释放驱动棘爪42。
参考图55-61,当关节运动的一次性加载装置被紧固在细长主体14中并且关节运动杆30以图55中箭头“M”所示方向枢转时,凸轮构件136通过突出部142(图10)以箭头“N”所示的方向在旋转把手28的凸缘170和172间被枢转。由于脊156(见图13)防止了平移构件138旋转,因此固定在平移构件138上的销166被迫沿着阶梯凸轮表面移动。销166的移动使得平移构件138以图55和56中箭头“P”所示方向进行相应的移动,从而向远端方向推进第一关节运动连接件123。第一关节运动连接件123的远端与在安装组件202上连接了突出部262的第二关节运动连接件256(见图42)的近端接合,从而以图57中箭头“Q”所示方向推进第二连接件256。突出部262从枢转构件244中横向移动,从而第二关节运动连接件256的远端推进能引起安装组件202以及工具组件17以图57和58中箭头“R”的方向枢转。从图59中可注意到,旋转构件28能够被转以围绕纵轴旋转细长主体14,同时工具组件17被关节运动。
图60-61示出了在与上述方向相反的方向使工具组件17关节运动。当第二关节运动连接件256通过以图55所示逆时针方向(未示出)旋转关节运动杆30来被回缩时,销66被迫沿着阶梯凸轮表面148向近端移动,并向近端移动平移构件138和第一关节运动连接件123。第一关节运动连接件123向近端的移动使得第二关节运动连接件256在以图58中箭头“S ”所示方向移动,从而以图61中箭头“T”所示方向顺时针旋转工具组件17。
参考图12,在邻近阶梯部340之间的销166(图19)的移动使得工具组件17关节运动22.5度。凸轮表面148包括五个阶梯部340。第三阶梯部对应于非关节运动工具组件位置,而第一和第五阶梯部对应于工具组件17的四十五度的关节运动。每个阶梯部是平坦的,以当销166与关节运动杆30接合时将关节运动杆30保持在固定位置。
参考图37、39、62和63,锁定操作的顺序将被详细描述。在图39中,锁定装置288在其优选的位置被示出,该装置带有搁在突出部330顶部上的水平凸轮300和302,该突出部在下半壳体252中的侧壁(图37)中形成。在此位置中,锁定装置288被支撑起,脱离与形成在下半壳体252底部表面的突出物332的对齐,而网298与设定在驱动横梁266中的架334纵向并列设置。此结构允许砧座20(图38)被打开并再定位在待缝合组织上,直到外科医生对该位置满意,无需启动锁定装置288来禁止一次性加载装置16工作。
如图62所示,经过驱动梁266的远端移动,锁定装置288解开突出部330(未示出)并且其通过弹簧304被偏置成在突出部332的远端与基础半壳体252接合。在装置击发期间,该锁定装置288保持此结构。
在驱动梁266以图62中箭头“U”所示方向回缩后,锁定装置288穿过突出部330下方并穿过突出部332直到锁定装置的最远部分接近突出部332。弹簧304将锁定装置288偏置在并列排列的突出部332,以有效地禁止一次性加载装置工作。如果要重新制动该装置,控制杆52将抵接锁定装置288的近端表面(该表面呈对角倾斜),以产生围绕枢轴342的力矩,从而锁定装置288的远端被可旋转地促动成与突出部332连接。向远端以图63中箭头“W ”所示的方向持续施力,将仅作用于增加施加在锁定装置上的力矩,因此锁定装置将抵接突出部332从而抑制控制杆52的远端移动。
再次参考图41-44,被禁止或锁定的一次性加载装置能够通过以图41、42和44中箭头“B”所示方向旋转一次性加载装置16来从细长主体14的远端中移除,以此将第二关节运动连接件256的钩部258从第一关节运动连接件123中的指形部164中脱离,以及将突块254从细长主体14的通道314中脱离。在旋转后,一次性加载装置16能以图41中箭头“A”所示方向的相对方向滑动,以将主体14从一次性连接装置16中分离出来。之后附加关节运动和/或非关节运动的一次性加载装置可被紧固在细长主体的远端,如上所述,以此执行其它的外科缝合和/或切割手术。如上所述,每个一次性加载装置可以包括尺寸在大约30mm到60mm间的各种缝钉的线性排。
尽管上述外科缝合器可以适用于它们的预定目的,但是下面仍然提供对这些设备的改进。如上文所述,外科缝合器可以包括把手部分、细长主体或轴部,以及一次性加载单元,其中一次性加载单元被可移除地连接在细长主体上。如上文所述并联系图40-42所示的一次性加载单元16,外科缝合器的细长主体14可以形成轴,一次性加载单元16可以沿着该轴组装。但是在多种情况下,一次性加载单元16可能无意中从细长主体14脱离,致使外科缝合器发生故障或不能操作。当一次性加载单元沿着由细长主体形成的轴(即一次性加载单元组装到细长主体所沿着的轴)而从细长主体脱离并分开时,这些情况尤其可能发生。在本发明的各种实施方式中,一次性加载单元可以沿着与细长主体轴既不共线、也不平行的方向而被安装到外科器械的细长主体上。在至少一个实施方式中,参照图65,一次性加载装置1016可以沿着与轴1015横向、垂直或倾斜的方向而被安装到细长主体1014上,其中轴1015由细长主体1014形成。
在各种实施方式中,参见图66和67,一次性加载装置1016可以包括连接器部分1017,其可设置为与细长主体1014的连接器部分1019相接合。在至少一个实施方式中,连接器部分1017可以包括至少一个突起部和/或凹槽,它们可以和连接器部分1019的至少一个突起部和/或凹槽相配合。在至少一个这样的实施方式中,连接器部分可以包括协作的楔形榫头部分。在各个实施方式中,连接器部分可以设置为互相锁定,并且防止(或至少抑制)一次性加载装置1016沿着轴1015的向远端和/或近端的移动。在至少一个实施方式中,类似于上述设备,外科缝合器可以包括与一次性加载装置1016的驱动部件1212可操作相连的控制杆1052,这样例如在把手24(图1所示)的推动下,驱动部件1212可以被向远端驱动,以从一次性加载装置1016排出缝钉和/或切割组织。在至少一个这样的实施方式中,驱动部件1212可以包括孔1272,其可设置为容纳从控制杆1052延伸的突起部1276。在各个实施方式中,这样的布置可以允许一次性加载装置1016沿着与轴1015既不共线也不平行的方向安装到细长主体1014上。尽管未有显示,但是驱动部件1212和控制杆1052可以包括任何其他合适的突起部和孔的排列,以可操作地将它们互相连接。同样与上述设备类似地,外科器械可以包括第一关节运动连接件1123,其可操作地与第二关节运动连接件1256相接合,这样关节运动杆1030的操作可以被传送到一次性加载装置1016。
在各个实施方式中,进一步地,连接件部分1017和1019的突起部和/或凹槽可以设置为,它们可以被压合在一起,以防止(或至少抑制)一次性加载装置1016沿着横向于轴1015的方向移动。在至少一个实施方式中,首先参照图68和69,可以利用套筒或套环将一次性加载装置固定在细长部件上。在各个实施方式中,套环1021可以与一次性加载装置1016的螺纹部分1023螺纹接合,以防止连接器部分1017和1019互相脱离。在至少一个实施方式中,套环1021可以包括孔1025,孔1025具有:可与螺纹部分1023螺纹接合的螺纹部分1027,以及可紧密容纳细长部件1014以防止(或至少限制)一次性加载装置1016和细长部件1014之间相对运动的第二部分1029。可选地,尽管未显示,套环可以设置为与细长部件1014螺纹接合并且紧密容纳一次性加载装置1016。在至少一个实施方式中,套环可以设置为与细长部件和一次性加载装置螺纹接合。
在各个实施方式中,可以用棘爪机构将一次性加载装置固定在外科缝合器的细长部件上。在至少一个实施方式中,参照图70-72,细长部件2014可以包括至少一个球形棘爪2031,它可设置为与一次性加载装置2016接合并将其固定就位。在各个实施方式中,细长部件可以包括用于容纳球形棘爪2031的至少一个孔2033,以及用于将球形棘爪2031固定在孔2033中的至少一个阻挡件2035。在至少一个实施方式中,阻挡件2035也可以设置为将球形棘爪2031偏置进一次性加载装置2016中的凹陷部2037中,这样就可以防止(或至少抑制)一次性加载装置2016沿着轴2015移动。在使用中,一次性加载装置2016的插入片2193可以插进细长部件2014中,这样一次性加载装置2016的端部可以与球形棘爪2031相接触,并使它们在孔2033内径向移动。一旦一次性加载装置2016插入到合适深度,凹陷部2037可以大致与孔2033排成一排,并且阻挡件2035可以将至少一部分球形棘爪保持在凹陷部2037内。
在各个实施方式中,进一步地,阻挡件2035的至少一个可以由弹性材料制成。在至少一个实施方式中,球形棘爪2031和阻挡件2035可以构成并设置为,阻挡件2035被球形棘爪2031向外偏离,并且因此,弹性部件2035可以对球形棘爪2031施加偏置力。为了将一次性加载装置2016从细长部件2014释放,细长部件2016可以进一步包括致动器2039,可以操作它从而将阻挡件2035收回近端,这样弹性部件2035的切口2041可以与球形棘爪2031对准(或至少大致对准)。在各个实施方式中,当一次性加载装置2016被从细长部件2014中的孔拉出时,切口2041与球形棘爪2031的对准可以允许球形棘爪2031被径向移动,并脱离与凹陷部2037的接合。在至少一个实施方式中,参照图70和73,细长部件2014可以进一步包括返回弹簧2043,其可设置为将致动器2039和阻挡件2035向远端推动,并相对于球形棘爪2031重新定位阻挡件2035。在各个实施方式中,如图71和72所示,球形棘爪2031可以是球形的(或者至少大致是球形的),并且可以由任何合适的材料例如不锈钢制成。在其它各个实施方式中,尽管未显示,棘爪2031可以具有任何合适的非球形形状。
在各个实施方式中,外科器械的一次性加载装置和细长部件可以包括协作的扣合装置,用于将一次性加载装置固定在外科缝合器上。在至少一个实施方式中,尽管未显示,一次性加载装置可以包括从其延伸的臂部,该臂部可至少部分地容纳在细长组件的孔或凹陷部中。在使用中,臂部可以设置为,当被插入细长部件时它们相向(toward each other)向内弯折,当与孔对准时它们则弹性地向外弹出。在各个实施方式中,外科器械可以包括锁定件,其可滑入臂部中间以将臂部固定在孔中,从而防止(或至少抑制)一次性加载装置从外科器械脱离。在至少一个实施方式中,锁定件可以在扳机的操作下向远端滑动。在各个可选实施方式中,锁定件可以包括一个或更多凸轮,这些凸轮设置为,当转动锁时,它们与臂部接合并将臂部固定在孔中。
在一次性加载装置已经连接到外科缝合器之后,可以将器械相对于病人的软组织定位。在各种情况下,外科缝合器可以包括砧座和钉仓,其中砧座可以相对于钉仓转动,以将砧座和钉仓相对于软组织定位。如上文所述并联系图38和40所示的一次性加载装置16,一次性加载装置16可以包括砧座组件20和钉仓组件18,其中砧座组件20可以在打开和闭合位置之间转动。在一些这样的器械中,如上文所述并参照图24,轴线驱动组件212可以设置为,在可移动把手24的第一操作下,其与砧座组件20的凸轮表面209相接触,并将砧座组件20移动到闭合位置中。在可移动把手24接下来的操作中,驱动组件212可以被推进穿过一次性加载装置16,以夹住、钉住并且切割位于钉仓组件18和砧座组件20之间的软组织。在这样的器械中,因为组织在被钉住并切割的同时被夹紧,因此部分软组织可以流出(或“挤出”)一次性加载装置的远端,并且在各种情况下,软组织可能不会被外科缝合器合适地处理。
在本发明的各个实施方式中,通过使用可以在缝钉从钉仓中排出和/或一次性加载装置内的驱动组件被推进之前对软组织施加夹紧力的外科缝合器,这些问题可以得到改善。在各种情况下,这样的实施方式可以防止(或至少抑制)软组织被挤出一次性加载装置的远端。在至少一个实施方式中,外科缝合器可以包括致动器,其设置为相对于一次性加载装置远端回缩,以在打开位置和闭合位置之间转动砧座,并将组织夹在位置上。在至少一个这样的实施方式中,参照图74-81,一次性加载装置3016可以包括钉仓组件3018和砧座组件3020,其中砧座组件3020可以通过致动器3043而向钉仓组件3018转动。在至少一个实施方式中,砧座组件3020可以包括:至少一个枢转片3211,其可被可旋转地容纳在例如钉仓组件3018中的孔或凹陷部中,以及至少一个凹陷部3047,其可设置为可操作地容纳致动器3043的至少一部分。当致动器3043被沿着由箭头“P”所示的方向拉动时,在至少一个实施方式中,致动器3043可以将砧座组件3020绕着由枢转片3211形成的轴转进闭合位置,并且对软组织施加夹紧力。
在各个实施方式中,如上文所述,致动器3043可以包括至少一个突起部3049,其可设置为与凹陷部3047的侧壁接合,并对砧座组件3029施加力。在至少一个实施方式中,这样的力可以产生扭矩或力矩,导致砧座组件3020在如图76所示的打开位置和如图77所示的闭合位置之间围绕枢转片3211旋转。在使用中,也如上所述,这样的扭矩可以对位于砧座组件3020和钉仓组件3018之间组织施加夹紧力。在各个实施方式中,施加在砧座组件3020的扭矩可以与由致动器3043施加的力以及突起部3049和枢转片3211之间的距离(即图77所示的距离“D”)成正比例。在至少一个实施方式中,一次性加载装置可以设计为,使距离D最大化(或至少实质性地增加),以对软组织施加更大的夹紧力或力矩。在至少一个这样的实施方式中,参照图80和81,钉仓组件3018可以包括具有孔或凹陷部3045的钉仓承载件3216,其中孔或凹陷部3045可以设置为允许突起部3049的至少一部分从其延伸穿过,这样可以增加在突起部3049和枢转片3211之间的距离。
在各个实施方式中,参照图75,一次性加载装置3016可以包括:可设置为将砧座组件3020偏置到打开位置的弹簧3051,以及可将致动器3043偏置进其最远端位置的弹簧。在使用中,如上文所述,致动器3043可以被向近端拉动,以将砧座组件3020转动到其闭合位置。在此情况下,如图77A所示,当致动器3043如下文中详细描述的那样被释放时,砧座组件3020可以弹性地压缩弹簧3051,这样弹簧3051可以将砧座组件3020返回其打开位置。在各个实施方式中,外科器械可以包括扳机或任何其他合适的执行装置,外科医生或其他临床医生可以操作该执行装置,从而将致动器3043向近端拉动,并且在至少一个实施方式中,将致动器3043锁定在其收回位置。在至少一个实施方式中,参照图1和9,致动器3043可被可操作地与关节运动杆30和第一关节运动连接件123接合,这样当关节运动杆30以第一方向旋转时,关节运动连接件123和致动器3043可以向近端回缩。同样地,当关节运动杠杆30以第二方向转动时,关节运动连接件123和致动器3043可被推向远端。在各种实施方式中,致动器3043可被推向远端以将突起部3049从凹陷部3047移除,并允许弹簧3051将砧座组件3020返回其打开位置。
在各个实施方式中,一次性加载装置可以包括具有凸轮的致动器,该凸轮设置为,在缝钉被排出进入软组织之前,凸轮可操作地与一次性加载装置的砧座接合,并给软组织施加压缩力。在至少一个实施方式中,参照图82和83,一次性加载装置4016可以包括砧座组件4020、钉仓组件4018和致动器4043,其中致动器4043可以设置为将砧座组件4020在图82所示的打开位置和图84所示的闭合位置之间转动。在各个实施方式中,参照图82和84,致动器4043可以包括凸轮4053,其中可以将致动器4043向近端(即以箭头“P”所示的方向)拉动,这样凸轮4053可以与砧座组件4020接合,并将砧座组件4020绕由枢转片4211形成的轴转动。与上文所述类似地,致动器4043可被可操作地与任何合适的扳机例如关节运动杆30接合,以触发致动器4043。
在各个实施方式中,致动器凸轮可以包括至少一个直线、非直线、弓形和/或曲线的轮廓。在至少一个实施方式中,凸轮4053可以包括具有例如顶点4055和初始接触点4057的弓形轮廓,例如,其中凸轮4053可设置为与砧座组件4020接合,这样初始接触点4057首先接触砧座组件4020。当致动器4053被进一步拉向近端时,凸轮4053可以相对于砧座组件4020滑动,这样凸轮4053的各个其它点接触砧座组件4020,直到顶点4055接触砧座组件4020,如图85所示。在这一点,砧座组件4020可位于其闭合位置。在各个实施方式中,再参照图85,顶点4055相对于枢转片4211可定位于近端(即在轴4059的近侧),因此可以防止砧座组件4020转回其打开位置,直到凸轮4053从砧座组件4020脱离(即相对于砧座组件4020向远端移动)。此外,顶点4055相对于枢转片4211的位置可以利用杠杆作用或机械利益(mechanical advantage),对软组织施加更大的夹紧力。
在各个实施方式中,当如上文所述凸轮4053向近端回缩并且砧座组件4020转进其闭合位置时,砧座组件4020可以接触例如位于砧座组件4020和钉仓组件4018中间的软组织。在至少一个实施方式中,当砧座组件4020最初接触到组织时,它可以对软组织施加初始夹紧力,并且其中当砧座组件4020被移进其最终或闭合位置时,砧座组件4020可以对软组织施加不断加大的力。在各个实施方式中,夹紧力可以以大致线性的方式增加。在至少一个实施方式中,凸轮(例如凸轮4053)可以设置为以这样的方式驱动砧座4020:即以非线性的方式增加施加给软组织的夹紧力。在至少一个这样的实施方式中,夹紧力可以以几何的方式增加,这样当砧座组件4020位于例如其最终或闭合位置时,夹紧力的峰值施加给软组织。因此,砧座可以在例如缝钉从钉仓中排出之前给软组织施加夹紧力,并防止(或至少抑制)软组织流出(或“挤出”)一次性加载装置的远端。
在各个实施方式中,进一步地,凸轮可以包括当砧座被移进其闭合位置时利用各种机械利益的轮廓。在至少一个实施方式中,凸轮可以包括复合轮廓,其包括在砧座的初始移动中利用第一机械利益或杠杆作用的第一部分,以及在砧座接下来的移动中利用第二机械利益或杠杆作用的第二部分。在至少一个这样的实施方式中,在砧座的最终移动过程中,可以利用更大的机械利益,以当砧座位于其闭合位置时,对软组织施加更大的夹紧力。
在各个实施方式中,参照图84和85,砧座组件4020可以包括组织接触表面(例如表面4063),其可定位为,当砧座组件4020在其闭合位置时,组织接触表面平行于(或至少大致平行于)在钉仓组件4018上的组织接触表面(例如表面4065)。在至少一个实施方式中,砧座组件4020和钉仓组件4018可以设置为,当砧座组件4020位于其闭合位置时,在砧座组件4020和钉仓组件4018之间形成有间隙。在各个实施方式中,在一次性加载装置的远端4069处,组织接触表面4063和4065之间的距离可以比近端4067处的距离短。在至少一个这样的实施方式中,因此,当砧座组件4020移进其闭合位置时,砧座组件4020的远端可以捕捉住一次性加载装置中的软组织。在其他各个实施方式中,在组织接触表面4063和4065之间的间隙可以在近端4067和远端4069之间具有一致(或至少大致一致)的距离。
在各个实施方式中,参照图86,致动器(例如致动器4043’)可以包括两个或更多的凸轮4053,它们可以设置为如上文所述与砧座组件4020的至少一部分接合。在至少一个实施方式中,凸轮4053可以从致动器4043’的轴部分4061’延伸,这样凸轮4053可以相对于砧座组件4020同时移动。在各个实施方式中,致动器4043’也可以包括至少一个钩部258,其设置为如上文所进一步描述的与第一关节运动连接件123接合。在各个可选实施方式中,参照图87,一次性加载装置可以包括两个或更多的致动器(例如致动器4043”),其每一个可包括一个或更多的例如凸轮4053,用于转动砧座组件4020。在至少一个这样的实施方式中,各个致动器4043”可以包括钩部258,其在外科缝合器中可被可操作地与一个或更多例如关节运动连接件相连。
在本发明的各个实施方式中,外科缝合器可以包括具有钉仓、砧座和套筒的一次性加载装置,其中套筒可以设置为相对于钉仓和砧座滑动,并且将砧座和钉仓中的至少一个固定就位。在至少一个实施方式中,参照图109和110,一次性加载装置5016可以包括至少一个套筒或套环(例如套筒5071),其可在如图109所示的近端位置和如图110所示的远端位置之间滑动。在至少一个实施方式中,套筒5071可以包括孔,当套筒5071定位在例如其远端位置时,这个孔可以至少部分地围绕或包围住砧座组件5020和/或钉仓组件5018。在各个实施方式中,套筒5071可以设置为防止砧座组件5020被过早地打开。此外,当位于砧座组件5020和钉仓组件5018之间的软组织被缝合和/或切割时,套筒5071可以防止(或至少抑制)砧座组件5020和钉仓组件5018被偏转。
在至少一个实施方式中,例如套筒5071可以设置为,给位于砧座组件5020和钉仓组件5018之间的软组织施加夹紧压力。在各个实施方式中,类似于上文所述,可以在手术缝钉被从钉仓中排出和/或软组织被切割之前施加这样的夹紧压力。在各个实施方式中,参照图109和110,套筒5071可以进一步包括槽5079,其可设置为,当套筒5071被推向远端时,套筒5071不可能接触和/或损伤位于砧座组件5020和钉仓组件5018之间的组织。
在各个实施方式中,外科缝合器可以包括悬臂(或舌部),设置为相对于钉仓和砧座中的至少一个滑动,并且与钉仓和砧座中的至少一个接合,以将它们固定在例如闭合位置。在至少一个实施方式中,参照图111和图112,一次性加载装置6016可以包括至少一个套筒或套环(例如套筒6071),其可在如图111所示的近端位置和图112所示的远端位置之间滑动。在至少一个实施方式中,套筒6071可以包括从其延伸的舌部6073,其可设置为与砧座组件6020的至少一部分接合,并对该部分施加力。在各个实施方式中,这样的力可以将砧座组件6020定位于抵住位于砧座组件6020和钉仓组件6018中间的软组织,并且将其夹紧在砧座组件6020和钉仓组件6018之间。参照图113,例如舌部6073可以包括任何适合的结构,包括弓形、直线形和/或曲线形结构。在至少一个实施方式中,舌部6073可以包括弯曲主体,其包括与套筒6071相连的近端6075和可设置为与砧座空腔6210中的砧座组件6020接合的远梢6077。在至少一个这样的实施方式中,在舌部6073和砧座组件6020之间传递的力可以通过梢部6077施加给砧座组件6020,因此,施加给软组织的力的位置可以用梢部6077的位置表示。
在各个实施方式中,套筒6071可以设置为,其可在缝钉被从钉仓组件6018排出并且组织被例如驱动部件6212切割之前,在其近端和远端之间推进。在至少一个这样的实施方式中,参照图113,舌部6073可以通过套筒6071向远端滑动,直到舌部6073的远梢6077在远端6069处接触砧座组件6020。然后,类似于上文所述,驱动组件6212可以被推向一次性加载装置的远端,以缝合和/或切割组织。在这样的情况下,由舌部6073施加给软组织的夹紧力可以施加在一次性加载装置的远端,并且组织从一次性加载装置的远端被挤出的可能性被降低。在其他各个实施方式中,当驱动部件6212例如被推向远端6069时,远梢6077可以被推向远端6069。在至少一个实施方式中,远梢6077可以设置为,在直接位于刀片6280上方(或至少接近刀片6280)的位置,接触砧座组件6020。在这样的实施方式中,舌部6073可以将砧座组件6020支撑在缝钉抵住砧座组件6020而变形的位置的正上方。
在一次性加载装置的砧座已经移进闭合位置之后,如上文所述,可以在一次性加载装置中推进驱动梁,以从其弹出缝钉和/或切割软组织。在各个实施方式中,驱动梁(例如驱动梁266)可以由单片材料和/或多片堆叠的材料构成。也如上文所述,驱动组件(例如驱动组件212)可以进一步地包括凸轮辊子286和支持部件287,它们可设置为分别将驱动梁固定在砧座组件20和钉仓组件18上。在各种情况下,将这样的部件组装到驱动梁266的时间和成本会较多。在本发明的各个实施方式中,可以降低这一时间和成本。尤其是,在本发明的至少一个实施方式中,驱动梁的一部分可以变形(或者整体形成),从而产生了不需要例如分别制造凸轮辊子286和/或支撑部件287的特征件。在各个实施方式中,参照图88-90,驱动梁1266可以包括一体的凸轮部件1286,其可从阻挡边缘1284横向地延伸。在至少一个实施方式中,驱动梁1266可以由板状(或至少大致板状)的材料件制成,其中材料件可以冲压,这样凸轮部件1286至少部分地与阻挡边缘1284分离,并以相对于驱动梁1266横向或倾斜的方向延伸。在至少一个这样的实施方式中,参照图90,凸轮部件1286可以这样定尺寸并设置:它们可以在砧座通道1210中滑动,并且至少帮助将砧座组件1020固定在闭合位置。此外或可替换地,尽管未显示,但是例如驱动梁1266的一部分可以设置为从驱动梁1266横向延伸,从而将驱动组件1212固定于钉仓组件。在至少一个实施方式中,类似于上文所述,在冲压过程中,阻挡边缘可以至少部分地与驱动梁1266分离,这样整体的阻挡边缘以相对于驱动梁1266横向或倾斜的方向延伸。在各个实施方式中,因此,至少一个整体的凸轮部件和/或至少一个整体的阻挡部件可以在适当的制造方法(例如连续冲压)中形成,这样可以降低(或甚至消除)将附件组装到驱动梁上的时间。
在各个实施方式中,参照图49,一次性加载装置的砧座可以包括形成在其中的槽,其可设置为容纳驱动梁的至少一部分。在至少一个实施方式中,参照图51和52,砧座可以包括从其穿过而延伸的通道,其中凸轮辊子286可以设置为与通道的侧壁接合并给砧座组件施加力。在各种情况下,这样的力可以导致砧座弹性地和/或塑性地变形,因此影响到手术缝钉在软组织中的发射。在本发明的各个实施方式中,砧座可以包括可能消除(或至少降低)砧座变形的特征。在至少一个实施方式中,砧座可以包括:具有缝钉包的用于将缝钉变形的第一部件、固定于第一部件的第一盖板,以及固定于第一部件和第一盖板中的至少一个的第二盖板,其中第一和第二盖板可以设置为支撑第一部件。在至少一个这样的实施方式中,参照图91-93,一次性加载装置7016可以包括砧座组件7020,其可包括:砧座部分204、附加在砧座部分204上的第一盖板208,以及附加在砧座部分204和第一盖板208中的至少一个上的第二盖板7081。在各个实施方式中,第一盖板208可以焊接到砧座部分204上,此外第二盖板7081可以焊接到第一盖板208和/或砧座部分204上。在至少一个实施方式中,第二盖板7081可以加强、加硬和/或增加砧座组件的截面模数,由此降低砧座组件在使用过程中不适当变形的可能性。
在各个实施方式中,参照图91,第一盖板208可以包括从其延伸的组织止挡208’。在至少一个实施方式中,组织止挡208’可以设置为,当砧座组件和钉仓组件被相对于软组织定位时,组织止挡208’可以防止(或至少抑制)软组织前进超过在一次性加载装置中的特定点。在本发明的各个实施方式中,参照图94,除上文所述外或可替换地,一次性加载装置7016a的第二盖板7081a可以包括从其延伸的组织止挡7081’。在各个实施方式中,一次性加载装置可以包括由一片或多片材料制成的第二盖板。在至少一个实施方式中,参照图95,一次性加载装置7061b可以包括第二盖板7081b,其中第二盖板7081b可以由单片材料例如不锈钢制成。在各个实施方式中,材料片可以在一个或更多成形砧座(forminganvil)(或心轴mandrel)上方变形,直到它弯曲成适合的形状。在至少一个实施方式中,材料片可以包括一个或更多的侧边缘7083b,在弯曲过程中,其可定位为抵住或靠近第二盖板7081b的中央部分7085b。之后,在至少一个这样的实施方式中,侧边缘7083b可以通过任何合适的制造方法例如焊接附加在中央部分7085b上。因此,在各个实施方式中,第二盖板7081b可以包括至少一个组织接触边缘7087b,其形成在材料片的两部分之间的弯曲处。在至少一个这样的实施方式中,组织接触边缘7087b可以具有圆形或放射状(radiused)轮廓,该轮廓可设置为边缘不会损伤软组织。在各个实施方式中,进一步地,砧座可以由一片材料形成,其中成形的砧座可以包括:具有第一侧和第二侧的中央部分,以及互相反向折叠的至少两个皮瓣(flap),其中一个皮瓣在第一侧,一个皮瓣在第二侧。
在各个实施方式中,参照图95,第一盖板208和砧座组件204可以在它们之间形成砧座空腔210。在至少一个实施方式中,如上文所述,空腔210可以设置为容纳凸轮致动器286,以及在各种情况下,第一盖板208可以设置为,在凸轮致动器286和空腔210的侧壁之间存在大的间隙。但是在这样的实施方式中,第一盖板208的结构不可能被最优化以将砧座组件相对于例如轴7089b的转动惯量最大化。如现有技术中所知,相对于轴具有更大转动惯量的设备相对于该轴可以更耐弯曲或变形。因此,在本发明的各个实施方式中,砧座组件的盖板可以设置为,在凸轮致动器286和盖板之间的间隙可被消除或至少减小。在至少一个实施方式中,参照图96,第一盖板7208c可以包括至少一个基部7093c和位于凸轮致动器286旁边(或与其紧靠接触)的至少一个侧壁7095c。在这样的实施方式中,侧壁7095c可以沿着使第一盖板7208c相对于轴7089b的转动惯量增加的方向延伸。在各个实施方式中,侧壁部7095c可以以相对于基部7093c垂直(或至少大致垂直)的方向定位。
在各个实施方式中,进一步地,砧座组件可以包括第一和/或第二盖板,第一和/或第二盖板中可包括筋板和/或皱折,它们可以加强或加硬砧座组件。在至少一个实施方式中,参照图97,一次性加载装置7016d的砧座组件可以包括砧座部分204和连接于砧座部分204的盖板7208d。在各个实施方式中,盖板7208d可以包括筋或皱折7097d,它们可以增加盖板7208d相对于轴7089b的转动惯量(moment of inertia)。在至少一个实施方式中,盖板7208d可以由一个或更多的材料(例如不锈钢)片加工而成,其中材料片可以弯成图97中所示的结构。根据现有技术,通过增加横截面的质量和/或增加质量与参考轴之间的距离,可以增加横截面的转动惯量。因为筋和/或皱折7097d可以在距离轴7089b一定距离外增加额外质量,因此它们与例如盖板208相比,可以增加盖板7208d的转动惯量。
在各个实施方式中,如上文所述,砧座组件的两个或更多部件可以焊接在一起。在本发明的至少一个实施方式中,砧座组件的两个或更多部件可以压合在一起,这样组件可以互相固定。在各个实施方式中,参照图98-101,砧座组件8020可以包括插入部分8099和盖子部分8101,其中参照图98和100,插入部分8099可以定位在由盖子部分8101形成的空腔8103中。然后,参照图101,盖子部分8101的至少一部分可以变形、冲压或锻模,这样插入部分8099的至少一部分被捕获(capture)在空腔8103中。在至少一个实施方式中,插入部分8099可以包括不平整、粗糙和/或波纹状的表面,该表面可设置为,当其变形时,其与盖子部分8101的一些部分互锁。
在各个实施方式中,参照图100,空腔8103可以包括槽8105,其可设置为,可滑动地容纳插入部分8099的尖头8107,其中盖子部分8101可以变形以将尖头(或臂部)8107捕获(capture)在槽8105中。在至少一个实施方式中,臂部8107可被压合在槽8105中,其中在各种情况下,这样的压合可以足以将插入部分8099固定在盖子部分8101中。在各个实施方式中,砧座组件的盖子部分和插入部分可以由相同的或不同的材料制成。在至少一个实施方式中,盖子部分可以由比插入部分更软或更有延展性的材料制成。在至少一个这样的实施方式中,盖子部分可以至少部分地由例如铝制成,而插入部分可以至少部分地由例如钢制成。无论怎样,盖子部分可以由可冲压或铸造的材料制成,以在其中形成缝钉变形包。在至少一个这样的实施方式中,盖子部分然后可以被阳极化。
在各个实施方式中,如上文所述,砧座组件可以包括砧座部分,其中具有缝钉变形包和用于支持砧座部分的盖板。在至少一个实施方式中,砧座部分和盖板可以一体化形成。参照图102-103,砧座8020a可以由材料管或环制成,其中,在至少一个实施方式中,可以将管的至少一部分(例如部分8109a)移除。在至少一个这样的实施方式中,管的其余部分(例如部分8111a)可以用冲压或成形工艺来变形,这样砧座8020a可以包括共面的(或至少大致共面的)从支撑部分8208a延伸的砧座部分8204a。在各个实施方式中,管可以至少部分地由挤制铝制成,在至少一个实施方式中,在管的该部分被移除之前和/或之后,缝钉变形空腔206可以在管中形成。
在各个实施方式中,如上文所述,砧座组件可以由两个或更多压配在一起的部件制成。在至少一个实施方式中,参照图105和106,砧座组件8020b可以包括第一(或插入)部分8099b和第二(或盖子)部分8101b,其中插入部分8099b可以插入盖子部分8101b的空腔8103b中。在至少一个实施方式中,插入部分8099b的外表面可以形成比由外部分8101b的外表面所形成的周缘更大的周缘,因此,当插入部分8099b插入空腔8103b中时,插入部件8099b可以将外部分8101b向外扩展。由于这样共同协调的几何形状,可以在部件8099b和8101b的表面之间产生相当大的法向力(normal force)。在至少一个这样的实施方式中,因此,可能需要相当大的拉力以克服在部件8099b和8101b之间由大的法向力而导致的摩擦力。
在各个实施方式中,砧座组件可以由两个或更多扣合在一起的部件构成。在至少一个实施方式中,参照图106-108,砧座组件8020c可以包括第一部分8099c和第二部分8101c,其中第二部分8101c可以与第一部分8099c扣合。参照图109,在至少一个实施方式中,第二部分8101c可以包括从其延伸的突起部8113c,其可设置为安装在槽8115c中。在各个实施方式中,第二部分8101c可以至少部分地由弹性材料例如不锈钢制成,当第二部分8101c的表面8117c向第一部分8099c的表面8119c移动时,所述弹性材料可允许突起部8113c向外位移。一旦表面8117c定位为抵住或靠近表面8119c,突起部8113c可被弹性地定位或扣合在槽8115c中,这样第二部分8101c固定于第一部分8099c。在至少一个实施方式中,第一和第二部分可以由相同的材料制成,或者它们可由不同的材料制成。在至少一个实施方式中,第一部分8099c可以至少部分地由铝制成,第二部分8101c可以支撑第一部分。
在各个实施方式中,参照图86,砧座可以包括砧座部件(例如砧座部件4204),其可包括从其延伸的筋或脊4153。在至少一个实施方式中,筋4153可以增加例如砧座部件4204的转动惯量或横截面模数,这样砧座组件4020就较少受不需要的变形的影响。在各个实施方式中,筋4153可以沿着砧座部件4204的周缘延伸。
在各个实施方式中,尽管未显示,其他部件可以组装到砧座上。在至少一个实施方式中,例如软的或易弯的鼻形件可以组装到砧座上以降低当砧座被插进手术位点时,砧座损伤软组织的可能性。在至少一个这样的实施方式中,鼻形件或任何其它合适的部件可以由任何合适的材料(例如橡胶和/或尼龙)制成。
在各个实施方式中,如上文所述,例如凸轮致动器286可以设置为与砧座组件接合,并将砧座组件定位为抵住位于砧座组件和钉仓中间的软组织。在本发明的至少一个实施方式中,参照图104和105,例如砧座组件8020b可以包括接触表面8121b,其中凸轮致动器286可以设置为与接触表面8121b接合并将砧座组件8020b固定在闭合位置。在各个实施方式中,接触表面8121b可以设置为它们向内朝着驱动梁1266延伸,这样接触表面的至少一部分定位为靠近(或接触)驱动梁1266。在至少一个实施方式中,因此,接触表面8121b可以设置为,在凸轮致动器286和接触表面8121b之间的接触区域被最大化(或至少被增加)。由于增加的接触区域,由致动器286施加给接触表面8121b的压力可被减小,砧座组件磨损和/或局部压弯(galling and/or localized yielding)的可能性被降低。
在各种情况中,尤其是在例如内窥镜或腹腔镜手术过程中,外科缝合器的至少一部分可以穿过套管或套针插入手术位点。通常,在一次性加载单元的砧座被插进套管之前,其被移进闭合位置,然后在被插入套管之后再重新打开。即使在砧座处于闭合位置时,一些具有大砧座和/或钉仓的一次性加载单元可能不适合(或不轻易适合)穿过套管。在本发明的各个实施方式中,外科缝合器可以包括具有砧座的一次性加载单元,其可在打开、闭合和/或有助于一次性加载单元插入套管的折叠位置之间移动。尤其是,在至少一个实施方式中,砧座可被移进闭合位置和折叠位置,其中在闭合位置,砧座离开钉仓例如第一距离,在折叠位置,砧座更靠近钉仓,这样一次性加载单元可以更加自由地插入套管。
在本发明的各个实施方式中,进一步地并参照图114-116,一次性加载单元9016可以包括砧座组件9020和钉仓组件9018,其中砧座组件9020可被相对于钉仓组件9018可转动地安装。在使用中,类似于上文所述,驱动组件212可以推向远端,这样凸轮致动器286可以接触砧座部件9204并使砧座组件9020在如图115和116所示的打开位置和如图117和118所示的闭合位置之间转动。当砧座组件9020转向钉仓组件9018时,在至少一个实施方式中,砧座组件9020可以设置为,将例如至少一个返还弹簧9051压缩进一次性加载单元中。
在至少一个实施方式中,参照图118,砧座组件9020可以进一步地包括组织接触表面9020’,类似地,钉仓组件9018可以包括组织接触表面9018’。在各个实施方式中,当砧座组件9020在闭合位置中时,组织接触表面9018’和9020’可分开第一距离9121。为了将砧座组件9020移进折叠位置,在各个实施方式中,致动器9043可被移向例如远端,这样致动器9043的部分9040可以接触砧座组件9020,并将砧座组件9020推向钉仓组件9018,如图119和120所示。在这样的折叠位置,在至少一个实施方式中,组织接触表面9018’和9020’可分开第二距离9125,这一距离可短于第一距离9121。在各个实施方式中,致动器9043可将砧座组件9020向下推,直到表面9020’至少部分地邻接表面9018’。
在各个实施方式中,进一步地,一次性加载装置可以包括至少一个返回弹簧,该返回弹簧可当砧座组件移进其折叠位置时被压缩。在至少一个实施方式中,参照图116和118,一次性加载装置9016可以包括弹簧9123,弹簧9123可当砧座组件9020在其打开位置和闭合位置之间移动时被压缩,并且,参照图118和120,当砧座组件移进其折叠位置时被进一步压缩。一旦砧座组件在其折叠位置,一次性加载装置就可以插入套管,套管在图121中用虚线以圆9155表示。在砧座组件9020的至少一部分和钉仓组件9018已经穿过套管后,致动器9043可以与砧座组件9020脱离,以允许弹簧9123将砧座组件从其折叠位置移进其闭合位置,如图122所示。此外,凸轮致动器286可以充分地脱离砧座组件9020,以允许弹簧9051将砧座组件9020移进其打开位置,这样砧座组件和钉仓组件可被相对于软组织定位。
在各个实施方式中,如上文所述,可以利用凸轮致动器286使砧座组件9020在打开位置和闭合位置之间移动,然后,可以利用致动器9043使砧座组件9020在闭合位置和折叠位置之间移动。可选地,致动器9043可设置为,当砧座组件9020位于其打开位置时致动器9043与砧座组件9020接合,并将砧座组件9020直接移进其折叠位置。在各种情况下,这样的实施方式可以允许医生更快速容易地将一次性加载装置插入套管中。在至少一个这样的实施方式中,在砧座组件的至少一部分已经插入套管中之后,致动器可充分地从砧座组件脱离,这样砧座组件可被直接移进其打开位置并相对于例如软组织定位。为了将一次性加载装置从手术位点移除,可将致动器再次与砧座组件接合,以将砧座组件移进其折叠位置,这样一次性加载装置可回缩到套管中。
关于上面进一步描述的一次性加载装置和外科器械,参照图41和42,一次性加载装置可插入外科器械的远端,并可相对于外科器械旋转,以可操作地将驱动组件和/或一次性加载装置的关节运动连接件与外科器械接合。在本发明的至少一个实施方式,这样的旋转可以将驱动组件解锁,并允许驱动组件如上文所述被推向远端。参照图123,一次性加载装置10016可以包括砧座组件10020、轴组件10125和闭锁设备10127,其中在一次性加载装置10016相对于外科器械的细长主体14(见图1)旋转之前,闭锁设备10127可以与驱动组件10212(见图128)接合。在至少一个这样的实施方式中,参照图124,闭锁设备10127可以包括楔形件10131,其可设置为,与例如驱动组件10212中的凹陷部接合,以防止(或至少抑制)在一次性加载装置10016被转动之前,驱动组件10212被推向远端。当一次性加载装置10016转动时,楔形件10131可与驱动组件10212脱离,因此,驱动组件10212可被如上文所述推向远端。
在各个实施方式中,参照图123和124,闭锁设备10127可以包括从其延伸的臂部10129,其可在一次性加载装置10016转动之前,与从轴组件10125延伸的突块254对准(或至少大致对准)。在至少一个实施方式中,参照图125和126,当一次性加载装置10016插入细长主体14中时,臂部10129和突块254可插入例如细长主体14中的槽10133中。当一次性加载装置10016被旋转,参照图174,臂部10129可被充分地限制在槽10133中,这样槽10133可将它们固定就位,反之,突块254可被定位为,它们不被限制在槽10133中,并可相对于臂部10129旋转。实际上,细长主体14可将闭锁设备10127固定就位,并且当轴组件10125与一次性加载装置10016转动时,驱动组件10212可被转动离开闭锁设备10127的楔形件10131。
为了将一次性加载装置10116从细长部件14分离,一次性加载装置10116和轴组件10125可以相反方向转动,这样突块254至少大致与臂部10129重新对准,因此突块254和臂部10129可从槽10133中回缩。这样的情况典型地发生在一次性加载装置已经使用或耗尽(expend)并且外科医生或其他临床医生希望将新的一次性加载装置组装到细长主体之后。但是在各种情况下,外科医生或其他临床医生可能不清楚一次性加载装置是否之前已经被耗尽。在本发明的各个实施方式中,可以利用上文所述的闭锁设备(或这里公开的任何其他合适的闭锁设备)来防止(或至少抑制)已经耗尽的一次性加载装置被重新组装到外科器械的细长主体上。
在各个实施方式中,参照图128,一次性加载装置10016可进一步包括偏置弹簧10135、致动器10137和从致动器10137延伸的致动器板10139,其中致动器板10139可设置为可操作地与弹簧10135接合。在一次性加载装置10116已经可操作地与细长部分14接合之后,如上文所述,驱动组件10212可被推向远端以缝合和/或切割组织。在至少一个实施方式中,致动器10137可被可操作地连接在驱动组件10212上,这样当驱动组件10212被推进时,驱动组件10212也可将致动器10137和致动器板10139拉向远端。一旦驱动组件10212已经被充分地推进,参照图129,致动器板10139可与偏置弹簧10135充分地脱离,从而将偏置弹簧10135从压缩状态释放,并允许偏置弹簧10135对闭锁设备10127施加偏置力。但是此时,当闭锁设备10127被细长部件14固定就位,如上文所述,至少只要一次性加载装置10016与细长部件14保持接合时,由弹簧10135施加的偏置力不能移动(或至少大致移动)闭锁设备10127。
在各个实施方式中,致动器板10139与偏置弹簧10135的脱离可以发生在缝钉被从钉仓中排开和/或切割部件可切割组织之前或与其同时发生。在至少一个这样的实施方式中,在不触发上述闭锁组件的情况下,医生可推进和回缩驱动组件10212以将砧座组件10020相对于软组织定位。在致动器10137已经被足够推进从而使板10139与弹簧10135分离之后,驱动组件10212可被进一步地推向远端,这样再参照图129,致动器10137和/或致动器板10139可以邻接例如位于一次性加载装置中的肩部。在至少一个这样的实施方式中,该肩部可防止致动器10137和致动器板10139在一次性加载装置中被进一步推动。但是,在进一步推动驱动组件10212的过程中,致动器10137可变得可操作地与驱动组件10212分离,这样驱动组件10212的推进不会传递给致动器10137。
在一次性加载装置10016已经从细长部件14分离之后,参照图130,偏置弹簧10135可以将锁定设备10127移入或转入臂部10129不再与突块254对准的位置。在至少一个这样的实施方式中,当臂部10129和突块254因为相互之间未对准而未能两者都安装在槽10133中时,这样的一次性加载装置10016不能被容易地重新组装到细长部件14上。在各个实施方式中,当外科医生或其他临床医生试图将耗尽的(或可能有缺陷的)一次性加载装置组装到医疗器械上时,这样的一次性加载装置可为他们提供直接反馈。这样的实施方式可以改善至少部分消耗的一次性加载装置被组装到外科器械上并被重新插入手术位点的情况,使医生发现一次性加载装置已经消耗。在各个实施方式中,驱动组件10212和致动器10137可设置为,在驱动组件10212被回缩的情况下,驱动组件10212不会导致驱动器10137重新接合偏置弹簧10135并将偏置弹簧10135返回其压缩状态。
在各个实施方式中,首先参照图126,细长部件14的槽10133可以包括大致矩形的沿着细长部件14的长度方向延伸的轮廓。虽然适合于其预定目的,但是可能发生难以将一次性加载装置组装到细长部件上的情况。尤其是,在至少一个实施方式中,一次性加载装置可设置为,外科医生或其他临床医生不能容易地观察到突块254是否与槽10133对准,并且在将一次性加载装置组装到细长部件14之前,医生可能花费时间将突块254与槽10133准确地对准。在本发明的至少一个实施方式中,参照图64,细长部件14’可包括具有发散状的和/或倾斜的端部10141’的槽10133’,其可有助于突块254插入槽10133’中,并可减少医生将一次性加载装置对准并组装到外科器械上所需花费的时间和/或精力。
如上文所述,在一次性加载装置已经至少部分消耗后,其可从外科器械脱离,并且新的一次性加载装置可被连接到外科器械上,这样可以重新使用外科器械。在各个实施方式中,之前的一次性加载装置如上文所述包括壳体、砧座组件和钉仓组件,以及用于将缝钉从钉仓组件中排出的缝钉驱动器和用于切割组织的切割部件。当这样的一次性加载装置的钉仓组件被至少部分地消耗,一次性加载装置的其余部分(例如壳体、砧座组件、缝钉驱动器和切割部件)通常与消耗的钉仓组件一起被丢弃。因此,为了更换这种之前的一次性加载装置,需要花费巨大的成本并造成不恰当的浪费。
在本发明的各个实施方式中,一次性加载装置可包括可替换的钉仓。在至少一个实施方式中,参照图131-135,一次性加载装置11016可包括砧座组件11020、钉仓通道11216和钉仓11018,其中钉仓11018可被可移除地连接到钉仓通道11216上。因此在至少一个实施方式中,第一个钉仓11018可用第二个钉仓11018(或者另一个合适的钉仓)代替,这样一次性加载装置的一个或更多个的其他部分可以循环使用(reuse)。在各个实施方式中,参照图132,钉仓11018可扣合在钉仓通道11216中,这样钉仓11018可被可靠地固定在钉仓通道11216中(并可容易地从中移除)。
在至少一个实施方式中,钉仓11018可包括具有至少一个缝钉空腔的主体11143,以及可连接到主体11143上的缝钉盘11145,其中缝钉空腔用于可移除地储存至少一个缝钉。在各个实施方式中,缝钉盘11145可与主体11143扣合和/或压合,以防止(或至少抑制)在缝钉空腔中的缝钉掉出主体11143的底部。在至少一个实施方式中,主体11143和/或缝钉盘11145可包括一个或更多个的突起部11147和/或孔11149,其可设置为将主体11143和缝钉盘11145互相固定。在各个实施方式中,缝钉盘11145可进一步包括例如突起部或波纹部11151,其可设置为与钉仓通道11216接合并将钉仓11018与钉仓通道11216固定。
在各个实施方式中,如上文所述,缝钉驱动器232和切割部件280可推向远端,以将缝钉从钉仓排出并切割软组织。然后,在本发明的至少一个实施方式中,缝钉驱动器232和切割部件280可相对于钉仓回缩,这样当更换钉仓时,缝钉驱动器232和切割部件280可被再一次向远端推进到新的钉仓中。在各个实施方式中,当钉仓被移除时,缝钉驱动器和/或切割部件可保持在用过的钉仓中,新的钉仓可包括位于其中的新的缝钉驱动器。在至少一个这样的实施方式中,各个钉仓可包括置于其中的缝钉驱动器和切割部件,这样用过的钉仓的缝钉驱动器和切割部件不再被循环使用。当缝钉驱动器和切割部件在使用过程中损坏和/或磨钝时,这样的实施方式很有用。在各个实施方式中,缝钉驱动器和切割部件可包括组件。在至少一个这样的实施方式中,切割部件可扣合和/或压合在缝钉驱动器中。在其他实施方式中,切割部件可由例如塑料制成,其可包覆成型在切割部件上。
如上文所述,一次性加载装置的砧座组件中可包括一个或更多的包,用于当缝钉从钉仓中弹出时使至少一个缝钉变形。在本发明的各个实施方式中,砧座可被连接到一次性加载装置上,这样其不能轻易地从一次性加载装置脱离,即使钉仓可被轻易地移除。但是在各种情况下,在一次和/或多次使用后,砧座会被磨损。在本发明的至少一个实施方式中,砧座组件的至少一部分可设置为,其可从一次性加载装置分离,并被用砧座组件的新的部分替换。在至少一个这样的实施方式中,在一次性加载装置重新使用之前,砧座组件和钉仓都可被替换。在各个实施方式中,进一步地,一次性加载装置可包括钉仓通道(或至少钉仓通道的一部分),其可从一次性加载装置分离。在至少一个这样的实施方式中,钉仓通道(或钉仓通道的一部分)可随钉仓一起被替换。
当一次性加载装置的钉仓和/或砧座被替换时,在本发明的各个实施方式中,钉仓和砧座可用相同的(或至少接近相同的)钉仓和砧座替换。例如在至少一个这样的实施方式中,30mm的钉仓可用另一个30mm的钉仓替换。但是在至少一个实施方式中,钉仓和/或砧座可用不同的钉仓和砧座替换。在至少一个这样的实施方式中,30mm的钉仓可用45mm的钉仓替换。当砧座组件和/或钉仓通道也可替换以容纳不同的钉仓时,这样的实施方式可尤其有用。可以想到其它的实施方式,其中钉仓用储存有不同的缝钉数量和/或排布的钉仓替换。在这样的实施方式中,类似于上文所述,砧座组件的至少一部分可替换,以容纳这样一个钉仓。在各个实施方式中,提供成套的砧座和钉仓以用于一次性加载装置和/或附随于一次性加载装置。在至少一个这样的实施方式中,刚性的砧座可与装有缝钉的钉仓一起使用,这就需要很大的力来使缝钉变形。在其它各个实施方式中,砧座可具有特殊的缝钉变形包(pocket),其经过特殊设计以使特定缝钉(例如长钉脚缝钉)变形。在至少一个实施方式中,砧座和钉仓可以包括对应的标记(例如颜色、数字和/或符号等),它们可以允许外科医生或其他临床医生容易地辨识出配对的砧座和钉仓。
几个上述的一次性加载装置实施方式使用了砧座作为例子,其中砧座具有可相对于钉仓的远端移动的远端。在各个可选的实施方式中,尽管未显示,但是一次性加载装置可包括砧座和钉仓,其中砧座可包括远端,这一远端相对于钉仓可旋转地安装在钉仓的远端上。在至少一个实施方式中,一次性加载装置可包括致动器,其可向远端位移以与砧座接合并且使砧座在打开位置和闭合位置之间转动。在至少一个这样的实施方式中,钉仓可包括钉仓和/或切割部件,其可从位于砧座远端附近的位置位移到砧座的近端。因此在至少一个这样的实施方式中,医生可更容易地观察到软组织是否已经正确地定位在钉仓和砧座之间和/或是否已经在钉仓和砧座中被正确地处理。
这里公开的器械可被设计为一次使用后丢弃,或者它们可被设计为多次使用。但是在任何一种情况下,器械都可在使用至少一次之后为了循环使用而被重新修整(recondition)。重新修整可包括器械拆卸,紧接着清洗或替换特定零件,以及重新组装的步骤的组合。尤其是,器械可被拆卸,并且器械的任何数目的特定零件或部件可被有选择地以任何组合替换或移除。在清洗和/或替换特定部件的过程中,为了随后使用,在重新修整的设备上,或由手术小组在手术过程之前立即重新组装器械。本领域技术人员将想到,器械的重新修整可以利用多种用于拆卸、清洗/替换和重新组装的技术。使用这样的技术以及由此重新修整后的器械,都在本申请的范围内。
优选地,这里所述的发明将在手术前进行处理。首先,获得新的或用过的器械并且需要的话进行清洁,然后器械进行灭菌处理。在一种灭菌技术中,器械被放置在闭合和密封的容器(例如塑料或TYVEK袋)中。然后容器和器械被放在可穿透容器的辐射场中,例如伽马射线、X射线或高能电子。辐射能杀灭在器械上和容器中的细菌。然后将灭菌后的器械储存在无菌容器中。密封的容器能保持器械无菌,直到在医疗设施(medical facility)中打开。
应当明白,可以对这里公开的实施方式进行各种修改。例如,缝合器不采用缝钉,而是采用现有技术中的两部分固定件(fastener)。进一步地,缝钉或固定件的直线排列长度可以进行修改,以满足特定手术过程的需要。因此,致动器轴的单个行程的长度,和/或缝钉和/或固定件在一次性加载装置中的直线排列长度可以相应地改变。因此,上述描述不应当解释为限制性的,而仅仅是作为优选实施方式的示例。在所附权利要求的范围和精神内,本领域技术人员能想到其它修改方案。

Claims (10)

1.一种用于外科缝合器的一次性加载装置,其包括:
钉仓承载件,其设置为可操作地支撑钉仓;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可旋转地安装,其中,所述砧座设置为在打开位置和闭合位置之间旋转,并且所述砧座包括可转动地安装到所述钉仓承载件的近端和能够相对于所述钉仓承载件运动的远端,其中所述砧座和所述钉仓承载件设置为限定一个枢轴,所述砧座可围绕所述枢轴旋转,所述砧座还包括邻近所述枢轴并面向所述钉仓承载件的凸轮表面;
驱动部件,其可相对于所述钉仓承载件和所述砧座移动,其中所述驱动部件设置为被从所述砧座的近端推向所述砧座的远端,以将缝钉从钉仓中排出;以及
致动器,其具有凸轮,所述凸轮能够在所述凸轮滑动离开所述砧座的所述远端时接触所述凸轮表面,以当所述致动器相对于所述远端被回缩时,使所述砧座在所述打开位置和所述闭合位置之间转动。
2.如权利要求1所述的一次性加载装置,其特征在于,所述砧座包括凹陷部,以及所述凸轮设置为与所述凹陷部接合并且使所述砧座旋转进所述闭合位置。
3.如权利要求2所述的一次性加载装置,其特征在于,所述钉仓承载件包括孔,其设置为允许所述凸轮的至少一部分穿入孔而延伸。
4.如权利要求1所述的一次性加载装置,其特征在于,所述凸轮包括具有顶点的弓形轮廓,并且所述顶点设置为当所述砧座在所述闭合位置时与所述砧座接触。
5.如权利要求1所述的一次性加载装置,其特征在于,所述致动器设置为可操作地与外科缝合器的控制杆耦合,这样可以操作所述控制杆以将所述致动器回缩。
6.如权利要求1所述的一次性加载装置,其特征在于,进一步包括所述钉仓。
7.如权利要求6所述的一次性加载装置,其特征在于,所述钉仓包括仓面,当所述砧座在其闭合位置时,所述砧座的远端比所述砧座的近端更接近于所述仓面。
8.一种用于外科缝合器的一次性加载装置,其包括:
钉仓承载件,其设置为可操作地支撑钉仓;
砧座,其包括至少一个缝钉变形空腔,其中所述砧座相对于所述钉仓承载件可旋转地安装,以限定枢轴,所述砧座能够围绕所述枢轴在打开位置和闭合位置之间旋转,并且所述砧座包括可转动地安装到所述钉仓承载件的近端和能够相对于所述钉仓承载件运动的远端,其中所述砧座还具有邻近所述枢轴并面向所述钉仓承载件的凸轮表面;以及
致动器,其可操作地与所述砧座接合,以当所述致动器从所述远端被回缩时,使所述砧座在所述打开位置和所述闭合位置之间转动,其中所述致动器包括凸轮,所述凸轮能够在所述凸轮滑动离开所述砧座的所述远端时接触所述凸轮表面,所述凸轮包括具有顶点的弓形轮廓,并且所述顶点设置为当所述砧座在所述闭合位置时与所述砧座接触。
9.如权利要求8所述的一次性加载装置,其特征在于,所述弓形轮廓包括由弧线的半径形成的圆形部分。
10.如权利要求8所述的一次性加载装置,其特征在于,所述致动器设置为可操作地与手术缝合器的控制杆耦合,这样可以操作所述控制杆以将所述致动器回缩。
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RU2494691C2 (ru) 2013-10-10
EP2090233A3 (en) 2011-10-12
EP3158944A1 (en) 2017-04-26
CN101507633A (zh) 2009-08-19
RU2009105161A (ru) 2010-08-20
JP2009189843A (ja) 2009-08-27
EP3158944B1 (en) 2019-08-21
BRPI0902421A2 (pt) 2010-04-20
EP2090233A2 (en) 2009-08-19
US20090206138A1 (en) 2009-08-20
PL2090233T3 (pl) 2017-06-30
EP2090233B1 (en) 2016-08-24
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BRPI0902421B8 (pt) 2021-06-22
US7959051B2 (en) 2011-06-14

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