CN101507631A - 具有负载敏感击发机构的外科缝合器械 - Google Patents
具有负载敏感击发机构的外科缝合器械 Download PDFInfo
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Abstract
本发明涉及具有能够进行外科手术的端部执行器的外科缝合器械,更具体地涉及具有负载敏感击发机构的外科缝合器械。所述外科缝合器械包括与可手动致动手柄连接的传动爪。传动爪可具有爪主体,爪主体上具有传动齿,传动齿可被构造成与致动轴相互作用,使得当可手动致动手柄被致动时,使传动齿与致动轴相互作用,引起致动轴将致动动作施加到与端部执行器可操作地连接的细长主体上。当端部执行器受到超过预定量的击发负载的击发负载时,传动齿相对于爪主体运动以与致动轴脱离,从而即使在可手动致动手柄继续被致动时也能防止致动动作进一步传递到细长主体。
Description
技术领域
本发明总体涉及内窥镜外科器械,包括但不限于具有能够将缝钉线施加到组织上同时切割缝钉线之间的组织的一次性装载单元的外科缝合器,具体涉及有关所述器械的改进。
背景技术
在此通过引用而包含在本申请中的下列美国专利申请由本申请的受让人共同拥有:
(1)Steven G.Hall等人的题为“Surgical Stapling ApparatusWith Interlockable Firing System”的美国专利申请,代理卷号No.END6217USNP/070334;
(2)Jerome R.Morgan等人的题为“Articulatable LoadingUnits For Surgical Stapling and Cutting Instruments”的美国专利申请,代理卷号No.END 6218USNP/070335;
(3)Kevin R.Doll等人的题为“Surgical Stapling ApparatusWith Reprocessible Handle Assembly”的美国专利申请,代理卷号No.END6220USNP/070337;
(4)Kevin R.Doll等人的题为“Surgical Stapling ApparatusWith Articulatable Components”的美国专利申请,代理卷号No.END6224USNP/070341;
(5)Steven G.Hall等人的题为“Surgical Stapling ApparatusWith Control Features Operable With One Hand”的美国专利申请,代理卷号No.END6226USNP/070343;
(6)Geoffrey C.Hueil等人的题为“Surgical StaplingApparatus With Retractable Firing Systems”的美国专利申请,代理卷号No.END6227USNP/070344。
内窥镜外科器械通常比传统的开放式手术装置更受青睐,因为切口较小,缩短了术后康复时间并减少了并发症。因此,适合用于将远端执行器通过套管针的套管精确地放置到需要的外科部位的内窥镜外科器械领域已经得到了极大发展。这些远端执行器以多种方式接合组织以达到诊断或者治疗效果(例如,内镜切割器、抓取器、切割器、缝合器、夹具施放器、进入装置、药物/基因治疗输送装置、以及采用超声波、RF、激光的能量装置等)。
已知的外科缝合器包括同时在组织中形成纵向切口并将缝钉线施加到切口的相对侧上的端部执行器。端部执行器包括一对协同作用的钳口构件,如果器械用于内窥镜或者腹腔镜应用,这对钳口构件能够穿过套管通道。其中一个钳口构件容纳具有至少两个横向间隔设置的缝钉排的钉仓。另一个钳口构件限定了具有与钉仓中的缝钉排对准的缝钉成形凹槽的砧座。所述器械一般包括多个往复运动的楔形件,当向远侧驱动时,这些楔形件穿过钉仓中的开口并接合支撑缝钉的驱动器,将缝钉向着砧座击发。
适用于内窥镜应用的不同类型的外科缝合器是已知的。例如,一种类型的外科缝合器采用钉仓。钉仓典型地支撑多个被定向在位于钉仓主体中的纵向延伸的狭槽的两侧上的缝钉,所述钉仓主体适于容纳被驱动纵向穿过其间的切割构件。当切割构件被驱动经过钉仓槽时,缝钉被向上驱动到器械的砧座部分中。切割构件可被支撑在驱动构件上,该驱动构件包括器械的远离钉仓的部分。那些类型的装置的例子在Jeffrey S.Swayze和Frederick E.Shelton,IV的题为“Surgical Stapling Instrument Incorporating a FiringMechanism Having a Linked Rack Transmission”的美国专利No.6905057和Jeffery S.Swayze,Frederick E.Shelton,IV,Kevin Ross Doll和Douglas B.Hoffman的题为“Multi-StrokeMechanism With Automatic End of Stroke Retractions”的美国专利No.7083075中有描述,这些专利在此通过全文引用而包含在本申请中。
其他类型的外科缝合器械被构造成用一次性装载单元(DLU)操作,该一次性装载单元被构造成将钉仓和刀组件支撑于其中。被设计成适应DLU的这种装置旨在为每次器械击发都提供“新”刀片的优点。这种外科缝合器械和DLU设置的例子在Milliman等人的美国专利No.5865361中公开,该专利的内容在此通过全文引用而包含在本申请中。
由于施加到击发系统的负载增加,现有外科缝合器械(诸如在美国专利No.5865361中公开的那些)受到在较厚组织(例如厚度大于3.5mm的组织)中不能被击发的困扰。这种增加的负载例如可增加当刀仍然在砧座中时击发系统故障的可能性,并会因此要求端部执行器脱离组织。这种故障模式可带来严重的患者伤害后果。
因此,需要适合与一次性装载单元一起使用的外科缝合器械,该一次性装载单元具有被构造成解决前述问题的改进击发系统。
发明内容
在本发明的一个方面,提供了一种被构造成与能够进行外科手术的端部执行器一起使用的外科器械。各种实施方式可包括细长主体,其被构造成可操作地与端部执行器连接以便将击发动作传递到端部执行器上。器械还可包括:用于产生致动动作的可手动致动的手柄;和致动轴,所述致动轴可操作地与细长主体和可手动致动手柄连接以便将通过手动致动手柄产生的致动动作传递到细长主体。各种实施方式可进一步包括与可手动致动手柄连接的传动爪。传动爪可具有爪主体,爪主体上具有传动齿。传动齿可被构造成与致动轴连接,当可手动致动的手柄被致动时,使传动齿与致动轴相互作用,引起致动轴将致动动作施加到细长主体上,并且当端部执行器受到超过预定量的击发负载的击发负载时,传动齿相对于爪主体运动,与致动轴脱离,防止致动动作进一步传递到细长主体,即便可手动致动手柄继续被致动时也是如此。
在本发明的各种实施方式的另一个总的方面,提供了一种被构造成用于与能够进行外科手术的端部执行器一起使用的外科器械。各种实施方式包括细长主体,其被构造成可操作地与端部执行器连接以便将击发动作传到到端部执行器上。器械还可包括用于产生致动动作的可手动致动的手柄。传动爪可与可手动致动手柄连接。致动轴可操作地与细长主体连接以便将致动动作传递到细长主体上。致动轴可具有位于其上的齿条(rack of teeth),齿条被构造成用于与传动爪的驱动接合。在各种实施方式中,当端部执行器受到超过预定量的击发负载的击发负载时,构成齿条的至少一部分齿被构造成可运动地脱离传动爪。
在本发明的各种实施方式的另一个总的方面,提供了一种外科缝合器械,其可包括手柄组件,手柄组件具有支撑于其上的可动手柄。所述器械可进一步包括细长控制杆,其被构造成与一次性装载单元连接。致动轴可由手柄组件可操作地支撑并被构造成与可动手柄和细长控制杆连接,以便将由可动手柄产生的致动动作传递到细长控制杆。致动传递组件可与可动手柄和致动轴连接,当可动手柄被致动时,使致动传递组件引起致动轴将致动动作施加到细长控制杆。致动传递组件可进一步被构造成当与细长控制杆连接的一次性装载单元受到预定量的击发负载时,防止致动动作被传递到细长控制杆,即便可动手柄可继续被致动时也是如此。
更具体地说,本发明涉及如下内容:
(1)、一种被构造成与能够进行外科手术的端部执行器一起使用的外科器械,所述外科器械包括:
细长主体,其可操作地与所述端部执行器连接以便将致动动作传到所述端部执行器上;
可手动致动手柄,其用于产生所述致动动作;
致动轴,其可操作地与所述细长主体和所述可手动致动手柄连接,以便将通过所述可手动致动手柄产生的所述致动动作传递到所述细长主体;和
传动爪,其与所述可手动致动手柄连接,所述传动爪具有爪主体,该爪主体上具有传动齿,该传动齿被构造成与所述致动轴相互作用,使得当所述可手动致动手柄被致动时,所述传动齿与所述致动轴相互作用,引起所述致动轴将所述致动动作施加到所述细长主体上,并且当与所述细长主体连接的所述端部执行器受到超过预定量的击发负载的击发负载时,所述传动齿相对于所述爪主体运动以与所述致动轴脱离,从而即使在所述可手动致动手柄继续被致动时也能防止所述致动动作进一步传递到所述细长主体。
(2)、如第(1)项所述的外科器械,其中,当所述击发负载超过所述预定量时所述传动齿从所述爪主体上脱离。
(3)、如第(2)项所述的外科器械,其中,所述传动齿在连接区与所述爪主体连接。
(4)、如第(3)项所述的外科器械,还包括位于所述爪主体中并邻近所述连接区的底切区域。
(5)、如第(1)项所述的外科器械,其中,所述爪主体具有爪宽度,其中所述传动齿具有小于所述爪宽度的齿宽度。
(6)、如第(3)项所述的外科器械,其中,所述传动齿通过粘合剂与所述连接区连接。
(7)、如第(1)项所述的外科器械,其中,所述致动轴上具有能够与所述传动齿驱动接合的齿条。
(8)、如第(7)项所述的外科器械,其中,当所述击发负载超过所述预定量时,构成所述齿条的至少一部分齿被构造成能够运动地脱离所述传动齿。
(9)、如第(1)项所述的外科器械,其中,所述传动齿能够运动地连接到所述爪主体,并通过剪切式构件保持在驱动位置中,当所述端部执行器受到超过预定量的击发负载时,该剪切式构件允许所述传动齿相对于所述爪主体运动。
(10)、一种处理用于外科手术的器械的方法,所述方法包括:
获得如第(1)项所述的外科器械;
对所述外科器械进行消毒;
将所述外科器械存储在无菌容器中。
(11)、如第(10)项所述的方法,还包括在进行消毒之前修复或替换所述外科器械的一部分。
(12)、一种被构造成与能够进行外科手术的端部执行器一起使用的外科器械,所述外科器械包括:
细长主体,其可操作地与所述端部执行器连接以便将致动动作传到到所述端部执行器上;
可手动致动手柄,其用于产生所述致动动作;
传动爪,其与所述可手动致动手柄连接;和
致动轴,其可操作地与所述细长主体连接以便将所述致动动作传递到所述细长主体上,所述致动轴具有位于其上的齿条,该齿条被构造成用于与所述传动爪驱动接合,其中当连接所述细长主体的所述端部执行器受到超过预定量的击发负载的击发负载时,构成所述齿条的至少一部分齿被构造成能够运动地脱离所述传动爪。
(13)、如第(12)项所述的外科器械,其中,所述齿条上的至少一部分齿被构造成当连接所述细长主体的所述端部执行器受到超过预定量的击发负载的击发负载时通过所述传动爪从所述致动轴上脱离。
(14)、一种用于处理外科器械的方法,该方法包括:
获得如第(12)项所述的外科器械;
对所述外科器械进行消毒;
将所述外科器械存储在无菌容器中。
(15)、如第(14)项所述的方法,还包括在进行消毒之前修复或替换所述外科器械的一部分。
(16)、一种外科缝合器械,包括:
手柄组件;
可动手柄,其由所述手柄组件可操作地支撑;
细长控制杆,其被构造成与一次性装载单元连接;
致动轴,其由所述手柄组件可操作地支撑并与所述可动手柄和所述细长控制杆连接以便将由所述可动手柄产生的致动动作传递到所述细长控制杆;
传动爪,其与所述可动手柄连接,所述传动爪具有爪主体,所述爪主体上具有传动齿,该传动齿被构造成与所述致动轴相互作用,使得当所述可动手柄被致动时,所述传动齿与所述致动轴相互作用,引起所述致动轴将所述致动动作施加到所述细长主体上,当与所述细长控制杆连接的一次性装载单元受到超过预定量的击发负载的击发负载时,所述传动齿相对于所述爪主体运动以从所述致动轴上脱离,从而即使在所述可动手柄被继续致动时仍然能够防止所述致动动作被进一步传递到所述细长控制杆。
(17)、如第(16)项所述的外科缝合器械,其中,所述控制杆能够在行进位置与回缩位置之间运动,其中当由所述一次性装载单元受到的所述击发负载超过所述预定量时,所述控制杆能够被运动到所述回缩位置。
(18)、如第(16)项所述的外科缝合器械,其中,所述致动轴上具有齿条,该齿条能够与所述传动齿驱动接合,其中当所述击发负载超过所述预定量时构成齿条的至少一部分齿被构造成能够运动地脱离所述传动齿。
(19)、一种用于处理外科器械的方法,该方法包括:
获得如第(16)项所述的外科缝合器械;
对所述外科缝合器械进行消毒;
将所述外科缝合器械存储在无菌容器中。
(20)、如第(19)项所述的方法,还包括在进行消毒之前修复或替换所述外科缝合器械的一部分。
附图说明
包含在本说明书中并构成其一部分、示出本发明的实施方式的附图与上面给出的本发明的一般描述以及下面给出的实施方式的详细描述一道,用于解释本发明的各种原理。
图1是本发明的各种实施方式的可重复使用的外科缝合器械的透视图,其具有与其连接的可进行关节运动的一次性装载单元。
图2是本发明的各种实施方式的可重复使用的外科缝合器械的透视图,其具有与其连接的不可进行关节运动的一次性装载单元。
图3是本发明实施方式的快拆紧固件的局部分解透视图。
图4是本发明的各种实施方式的可重复使用的外科缝合器械的分解组装图。
图5是图4的可重复使用的外科缝合器械的另一分解组装图。
图6是图4和5的可重复使用的外科缝合器械的手柄组件的一部分的分解组装图。
图7是本发明实施方式的击发组件的右侧局部透视图。
图8是图7中示出实施方式的击发组件的左侧局部透视图。
图9是图7和8中实施方式的击发组件的左视图。
图10是本发明的各种实施方式的控制杆组件实施方式的分解组装图。
图11是本发明实施方式的可旋转把手组件和关节运动机构的分解组装图。
图12是图1和2的被污染的可重复使用的外科缝合器械的透视图,其中一次性装载单元从其上拆下。
图13是图1和2的被污染的可重复使用的外科缝合器械的透视图,其中控制杆延伸到细长主体的远端之外。
图14是本发明实施方式的清洁方法的行动汇编的示意图。
图15是示出将伸出的控制杆浸没到清洗液中的透视图。
图16是本发明实施方式的清洁方法的其他行动汇编的另一示意图。
图17是示出将本发明的实施方式的各组成元件浸没到清洗液中的透视图。
图18是本发明的各种实施方式的击发组件实施方式的侧视图。
图19是本发明的重新组装方法的行动汇编的示意图。
图20是示出本发明的实施方式的组装盘的分解图。
图21是与不可进行关节运动的一次性装载单元连接的本发明的另一外科缝合器械的透视图。
图22是图21中示出的外科缝合器械的手柄组件的分解组装图。
图23是本发明的各种实施方式的另一一次性装载单元感测机构实施方式的分解组装图。
图24是本发明实施方式的另一可旋转把手组件和关节运动机构的分解组装图。
图25是本发明的实施方式的击发释放扳机组件的分解组装图。
图26是图25中示出的击发释放扳机组件的局部组装图。
图27是本发明实施方式的手柄组件的组装图。
图28是本发明实施方式的手柄组件的另一组装图,其中可动手柄组件被拉靠到固定手柄部分以闭合一次性装载单元上的砧座。
图29是本发明实施方式的手柄组件的另一组装图,其中在砧座已经被闭合时可动手柄被返回到开始位置。
图30是本发明实施方式的手柄组件在致动击发释放扳机之前的另一组装图。
图31是本发明实施方式的手柄组件的另一组装图,其中击发释放扳机被致动。
图32是本发明实施方式的手柄组件的另一组装图,其中击发释放扳机被致动并且可动手柄开始被致动。
图33是本发明实施方式的手柄组件的另一组装图,其中击发释放扳机被致动,并且可动手柄被拉靠到固定手柄部分。
图34是本发明实施方式的另一击发释放扳机的局部组装图。
图35是本发明实施方式的另一外科缝合器械的透视图。
图36是图35的外科缝合器械的可旋转护罩和一部分手柄组件的局部分解组装图。
图37是图35和36的外科缝合器械实施方式的一部分的透视图,其中一部分手柄外壳被除去以显示旋转模式下其中的各种组成元件。
图38是图36中示出的外科缝合器械实施方式的一部分的侧视图,其中其选择器开关处于远侧解锁位置。
图39是当器械处于旋转模式时从旋转锁定环脱离的锁栓(bo lt)的放大图。
图40是沿着图38中的线40-40截取的外科缝合器械的剖视图。
图41是图35-40的外科缝合器械的局部俯视图,其中握持部分以剖面显示。
图42是图35-41的外科缝合器械实施方式的一部分的透视图,其中一部分手柄外壳被除去以显示其中的处于关节运动模式下的各组成元件。
图43是图36中示出的外科缝合器械实施方式的一部分的侧视图,其中其选择器开关处于近侧锁定位置。
图44是锁栓与旋转锁定环接合以将该器械锁定在关节运动模式中的放大图。
图45是沿着图43中的线45-45截取的图43的外科缝合器械的局部剖视图。
图46是采用替代移动构件的本发明的外科缝合器械的手柄组件的局部剖视图。
图47是本发明的另一种外科缝合器械实施方式的透视图。
图48是图47的外科缝合器械的手柄组件部分的放大透视图,其中为清楚起见部分手柄外壳被除去。
图49是图47中示出的手柄组件的局部侧视图,其中为清楚起见部分手柄外壳被除去。
图50是图49中示出的手柄组件的局部俯视图,其中以剖面显示出一些组成元件并且关节运动系统处于锁定位置。
图51是图49和50中示出的手柄组件的局部俯视图,其中以剖面显示出一些组成元件并且关节运动系统处于解锁位置。
图52是本发明的另一外科缝合器械实施方式的透视图。
图53是图52的外科缝合器械的手柄组件部分的组装透视图,其中为清楚起见部分手柄外壳被除去并省略了传感器筒。
图54是图52和53中示出的外科缝合器械的一部分手柄组件的从左侧看的组装透视图,其中为清楚起见手柄外壳被除去。
图55是图52-54中示出的外科缝合器械的一部分手柄组件的从右侧看的组装透视图,其中为清楚起见手柄外壳被除去。
图56是一部分关节运动系统、齿轮和关节运动选择器开关实施方式的侧视图,其中关节运动选择器开关处于空档位置(neutralposition)。
图57是关节运动系统、齿轮和关节运动选择器开关实施方式的另一侧视图,其中关节运动选择器开关处于左侧关节运动位置。
图58是关节运动系统、齿轮和关节运动选择器开关实施方式的又一侧视图,其中关节运动选择器开关处于右侧关节运动位置。
图59是本发明实施方式的齿轮选择器开关、传动齿轮组件、关节运动传递齿轮链和关节运动杆的仰视图,其中齿轮选择器开关处于关节运动位置。
图60是本发明实施方式的齿轮选择器开关、传动齿轮组件、关节运动传递齿轮链和关节运动杆的仰视图,其中齿轮选择器开关处于击发位置。
图61是处于关节运动位置的齿轮选择器开关实施方式的放大图。
图62是处于击发位置中的齿轮选择器开关实施方式的剖视图。
图63是处于关节运动模式的外科缝合器械的各种组成元件的端视图。
图64是处于击发模式中的图63中示出的组成元件的另一端视图。
图65是本发明的替代关节运动机构实施方式的局部剖切的透视图。
图66是图65的关节运动机构的局部剖切俯视图。
图67示出了处于左侧关节运动位置中的图65和66的关节运动机构实施方式的凸轮盘和关节运动销的位置。
图68示出了处于正直(非关节运动)位置中的图65和66的关节运动机构实施方式的凸轮盘和关节运动销的位置。
图69示出了处于右侧关节运动位置中的图65和66的关节运动机构实施方式的凸轮盘和关节运动销的位置。
图70示出了本发明实施方式的另一关节运动机构的一部分的平面剖视图。
图71是图70实施方式的一部分关节运动机构的局部剖视图。
图72是本发明实施方式的又一关节运动机构的侧视图,其中其部分组成元件以剖面显示。
图73是沿着图72中的线73-73截取的图72的关节运动机构实施方式的剖视图。
图74是本发明实施方式的另一关节运动机构的侧视图,其中其一部分组成元件以剖面显示。
图75是图74实施方式的关节运动机构的外关节运动环的透视图。
图76是本发明实施方式的另一外科缝合器械的左侧透视图。
图77是在图76实施方式中示出的外科缝合器械的右侧透视图。
图78是手柄组件的右侧外壳部分的分解组装图,其中可拆卸盖从外壳部分上拆下。
图79是手柄组件的右侧外壳部分的另一视图,其中可拆卸盖从外壳部分上拆下。
图80是图76-78中示出的外科缝合器械的手柄组件的右视图。
图81是沿着图80中的线81-81截取的外壳组件的剖视图。
图82是沿着图80中的线82-82截取的外壳组件的剖视图。
图83是沿着图80中的线83-83截取的外壳组件和扳起把手(cocking knob)的剖视图。
图84是在图76-83中示出的外科缝合器械的手柄组件的右视图,其中可拆卸盖被除去以显示回缩把手和处于“预击发”位置的扳起把手。
图85是图84的手柄组件的另一右视图,其中扳起把手处于扳起位置。
图86是图84和85的手柄组件的另一右视图,显示在到达完全击发位置之前回缩把手和扳起把手的位置。
图87是手柄组件和扳起把手的局部剖视图,其中扳起把手沿着顺时针方向被偏压以释放锁定构件。
图88是手柄组件、扳起把手和回缩把手的另一局部剖视图,其中回缩把手已经释放锁定构件以允许关节运动轴被自动回缩。
图89是本发明的各种实施方式的一次性装载单元的一部分的局部透视图。
图90是本发明的各种实施方式的爪实施方式的透视图。
图91是本发明的各种实施方式的另一爪实施方式的透视图。
图92是本发明的各种实施方式的致动轴实施方式的仰视透视图。
图93是本发明的各种实施方式的另一种致动轴实施方式的仰视透视图。
图93A是本发明实施方式的一部分击发系统的侧视图,其可与在申请号为No.11/821277的美国专利申请中公开类型的外科缝合器械结合使用,其中齿与击发构件驱动接合。
图93B是图93A实施方式中的击发系统的另一侧视图,其中齿处于脱离位置。
图94是本发明实施方式的外科缝合器械和一次性装载单元的透视图。
图95是图94实施方式示出的一次性装载单元的透视图。
图96是图95实施方式的一次性装载单元的分解组装图。
图97是使用一对外科抓取器进行关节运动的图95和96的一次性装载单元的透视图。
图98是本发明实施方式的另一一次性装载单元的透视图。
图99是图98实施方式的一次性装载单元的分解组装图。
图100是使用一对外科抓取器进行关节运动的图98和99的一次性装载单元的透视图。
图101是图98-100的一次性装载单元的透视图,示出其无源关节运动行程和有源关节运动行程。
图102是本发明实施方式的另一一次性装载单元的透视图。
图103是图102实施方式的一次性装载单元的分解组装图。
图104是本发明的各种实施方式的另一一次性装载单元感测机构和控制杆组件实施方式的分解组装图。
图105是本发明实施方式的另一一次性装载单元的透视图,示出其无源关节运动行程和有源关节运动行程。
图106是图105的一次性装载单元的分解组装图。
图107是沿着图105中由箭头107-107所示的方向的图105和106的一次性装载单元的近端视图。
图108是本发明实施方式的另一外科缝合器械的透视图。
图109是在图108的外科缝合器械中采用的本发明实施方式的关节运动系统的分解组装图。
图110是图109的关节运动系统的中间关节运动接头的各部分的分解组装图。
图111是在开放式外科应用中采用的图108的外科缝合器械的透视图。
图112是本发明实施方式的另一外科缝合器械的透视图,其与常规套管针结合采用以便进行内窥镜外科手术。
图113是本发明实施方式的另一关节运动系统的透视图。
图114是图113的关节运动系统的局部分解组装图。
图115是图113和114的关节运动系统的侧组装图。
图116是本发明实施方式的另一关节运动系统的透视图。
图117是本发明实施方式的又一关节运动系统的透视图。
图118是图117的关节运动系统的分解组装图。
图119是图117和118的关节运动系统的一部分的侧组装图,其中为清楚起见其一些组成元件以剖面显示。
图120是本发明实施方式的关节运动杆和销的局部组装透视图。
图121是图120实施方式中示出的关节运动杆和销的剖视图。
图122是本发明实施方式的另一外科缝合器械的透视图,其与常规套管针结合使用以便进行内窥镜外科手术。
图123是图122实施方式的外科缝合器械的关节运动系统的局部分解组装图。
具体实施方式
参照附图,其中在所有附图中相同的附图标记表示相同的元件,图1示出了可重复使用的外科器械,在典型方案中其更具体地是能够实现本发明的各种实施方式的独特优点的外科缝合器械10。外科缝合器械10可包括手柄组件12和细长主体14。图1示出了具有与其连接的可进行关节运动的一次性装载单元16的外科缝合器械10。图2示出了具有与其连接的不可进行关节运动一次性装载单元16’的外科缝合器械10。一次性装载单元16、16’可包括工具组件17,其包括将多个外科缝钉容纳于其中的钉仓组件18。工具组件17可进一步包括缝钉成形砧座20。所述一次性装载单元16、16’可进行外科手术诸如切割组织并将缝钉施加到切口的每侧上。本发明的各种实施方式可与在Milliman等人的美国专利US5865361中公开的一次性装载单元结合使用,该专利的内容通过引用而包含在本申请中。
应当理解,术语“近侧”和“远侧”在本文中以临床医生握持器械的手柄为参照。因此,工具组件17是相对于更近侧的手柄组件12为远侧。还应理解,为了方便和清楚起见,空间术语“垂直”、“水平”、“上”、“下”、“右”和“左”在本文中以附图为参考来使用。但是,外科器械可以许多朝向和位置来使用,这些术语并不是限制和绝对化。
如上所述,现有的外科缝合器械诸如在美国专利US5865361中公开的那些不适于再生(即重新消毒)以便使器械重新被使用,因为它们不容易被拆卸。在图1-20中示出的外科缝合器械10适于常规再生并可与可进行关节运动的一次性装载单元16(图1)和不可进行关节运动的一次性装载单元16’(图2)结合使用(将在下面进一步讨论)。外科缝合器械10的各种实施方式可采用手柄组件12,其被构造成利于容纳在其中的各种组成元件的清洁和消毒。例如,手柄组件12可包括固定手柄部分22、可动手柄24和筒状部分26。可旋转把手28可被安装在筒状部分26的前端以利于细长主体14围绕缝合器械10的纵向轴线“L-L”相对于手柄组件12旋转。如同将在下面详细讨论的那样,一些手柄组件实施方式还可包括关节运动杆30,其被安装在与可旋转把手28相邻的筒状部分26的前端。其他实施方式也可被设计成与不可进行关节运动的一次性装载单元结合使用,因此手柄组件12可不包括所述关节运动组成元件。手柄组件12可进一步包括手柄外壳36,其可由第一外壳部分36a和第二外壳部分36b形成,当连接在一起时,二者形成手柄外壳36。为了方便手柄组件12的简单拆卸,外壳部分36a、36b可以至少一个快拆紧固件400连接在一起,优选以三个快拆紧固件400连接在一起。
如图3所示,快拆紧固件400可包括卡扣式紧固件,其包括螺钉头402,螺钉头402具有从其上伸出的筒状或者主体部分404,该主体部分404的尺寸适于容纳在外壳部分36a中形成的相应支座构件(stand off member)410中的孔412中。杆或横梁406被安装在主体部分404中以形成大体上T形的连接器部分408,该部分的尺寸适于被容纳在孔412的每侧上的槽部分414中。槽部分414被构造成当T形连接器部分408被插入到孔412和槽部分414中并且如图3中的箭头“T”所示转动时,由杆406将连接器部分408可释放地保持在位置中。在各种实施方式中,快拆紧固件400的主体部分404可延伸穿过外壳部分36b中的相应孔,然后将杆或横梁406与外壳部分36b连接,使快拆紧固件400与第二外壳部分36b不可拆卸地连接,于是当外壳部分36b从第一外壳部分36a上拆下时,快拆紧固件400不从第二外壳部分36b脱开并且与第二外壳部分36b保持在一起,以便进行清洁/消毒。
参见图4-8,可动手柄24可枢转连接到击发组件500,为清洁/消毒目的该击发组件500可从手柄外壳36上除去。在各种实施方式中,击发组件500可包括可操作地支撑可动手柄24的内部机架组件510。如同可以从那些附图中看出的那样,可动手柄24可通过枢轴销38枢转连接到内部机架组件510。可包括扭转弹簧的偏压构件40偏压可动手柄24远离固定手柄部分22。见图6-8。致动轴46可被支撑在内部机架组件510内并可包括齿条48。具有齿条接合齿43的传动爪42绕枢轴销44枢转安装到可动手柄24的一端上。见图8。可包括扭转弹簧的偏压构件50被定位成向着致动轴46的齿条48促动传动爪42。见图7。可动手柄24可枢转,以使传动爪42的齿条接合齿43运动到与致动轴46的齿条48接触,从而沿远侧方向“DD”线性行进致动轴46。致动轴46的远端可具有在其中形成的腔47以容纳控制杆52的近端49(图4),使致动轴46的线性行进引起控制杆52的相应线性行进。
内部机架组件510可进一步包括锁定爪54,锁定爪54上具有锁定突起55并围绕枢轴销57可枢转连接到机架组件510,并可由可包括扭转弹簧的偏压构件56偏压到致动轴46中的腔512中。锁定爪54的锁定突起55可运动成与腔512接合,从而在没有一次性装载单元与细长主体14连接时将致动轴46保持在纵向固定位置中(将在下面进一步详细讨论)。
内部机架组件510还可操作地容纳回缩机构58,该回缩机构可包括右侧回缩器把手32a和左侧回缩器把手32b,二者都通过连接杆60与致动轴46的近端连接。见图6。连接杆60可包括:右和左接合部分62a和62b,以便分别容纳回缩器把手32a和32b;中央部分62c,该中央部分的尺寸被设置并被构造成在内部机架组件510中的一对纵向槽514中和在致动轴46中邻近致动轴近端形成的槽34a中移动。回缩器把手32a、32b每个中可具有腔,使它们能够被分别压到相应的接合部分62a、62b上。在本发明的各种实施方式中,连接杆60可被构造成,当回缩器把手32a、32b为拆卸目的而从连接杆上被除去时连接杆60保持与内部机架组件510的安装位置。见图7、8和17。如图6中所示,中央部分62c可设置有切口63,其适于由在保持器520的近端上形成的保持片(未显示)保持接合,所述保持器滑动容纳在致动轴46中的腔522中。回缩弹簧524连接在致动轴46中的横向柱526和保持器520之间以向远侧拉动保持器520,使在保持器近端上形成的保持片与连接杆60中的切口63保持接合。本领域普通技术人员将会理解,当回缩器把手32a、32b从连接杆60上拆下时,连接杆60通过保持器520上的保持片与内部机架组件510保持连接。
释放板64可以可操作地与致动轴46连接并安装以便响应于回缩器把手32a、32b的操作相对于致动轴运动。一对间隔设置的销66可从致动轴46的侧面向外延伸以接合在释放板64中形成的一对相应倾斜凸轮槽68。当回缩器把手32a、32b沿着近侧方向“PD”运动时,销66可相对于致动轴46并相对于齿条48向下释放释放板64,使释放板64的底部部分在齿条48下方延伸,从而使传动爪42的齿条接合齿43从齿条48上脱离。横槽70在释放板64的近端处形成以容纳连接杆60的中央部分62c,并且细长槽34(图1)在手柄组件12的筒状部分26中限定,以便在回缩把手32a、32b沿着近侧方向“PD”被拉动以回缩致动轴46并由此沿着近侧方向“PD”回缩控制杆52时用于连接杆60的纵向移动。
在各种实施方式中,内部机架组件510还可操作地支撑击发锁定组件80,该击发锁定组件80可包括插棒(plunger)82和枢转锁定构件83。见图7和8。插棒82由(两个)偏压弹簧84偏压到中央位置并包括环锥形凸轮表面85。插棒82的每个端部延伸穿过手柄外壳36并与固定手柄部分22的上端相邻。可枢转锁定构件83可在其远端围绕枢轴销86枢转连接并可包括锁定门88和近侧延伸件90,该近侧延伸件90具有在其中形成的槽89。见图7和8。可枢转锁定构件83可由弹簧93偏压(图9),引起与其连接的锁定门88进入致动轴46底部中的锁定定位凹槽53中,以防止致动轴46的行进以及缝合器械10的随后击发。插棒82上的环锥形凸轮表面85被定位以延伸到近侧延伸件90中的锥形槽89中。插棒82抵抗任一弹簧84的偏压沿着任一方向的侧向运动使锥形凸轮表面85运动成与近侧延伸件90中的锥形槽89的侧壁接合,以围绕枢轴销86枢转可枢转锁定构件83,从而将锁定门88运动到锁定定位凹槽53之外,由此允许致动轴46行进。
如同从图6-9中进一步看出的那样,传感器连接件182还可由内部机架组件510可操作地支撑。如同从那些图中看出的那样,传感器连接件182可通过延伸穿过传感器连接件182中的槽532的销或螺钉530与内部机架组件510滑动连接,使传感器连接件182可相对于内部机架组件510纵向滑动。弹簧531的远端可与螺钉530连接并且弹簧531的近端可钩在传感器连接件182的钩533上。见图6。弹簧531用于沿着远侧方向“DD”偏压传感器连接件182。传感器连接件182可进一步包括近侧锁定臂535,其具有被构造成与锁定爪54相互作用的向内突出的近端537。特别是,当没有一次性装载单元16、16’与缝合器械10连接时,传感器连接件182由弹簧531向远侧偏压。当处于该“未装载”位置中时,近侧锁定臂535的近端537与锁定爪54脱离,以将锁定爪54保持在锁定位置,其中锁定突起55被容纳在腔512中,将致动轴46保持在纵向固定位置中。因此,当没有一次性装载单元16、16’与外科缝合器械10连接时,缝合器械10不能被正常击发。
传感器连接件182可进一步具有在其上形成的向下延伸的远侧片534以便与在传感器筒178上形成的凸缘179接触。见图4和5。如同将在下面进一步详细讨论的那样,传感器管176被定向为连接传感器筒178,见图10。传感器连接件182可进一步具有弹簧臂536,该弹簧臂具有与可枢转锁定构件83上的凸轮表面83a接合的向下延伸端部538,见图7。当一次性装载单元16、16’与细长主体14的远端连接时,一次性装载单元16、16’与传感器管176的远端接合以向近侧驱动传感器管176,从而向近侧驱动传感器筒178和传感器连接件182。传感器连接件182向近侧的运动引起弹簧臂536的端部538使凸轮表面83a向近侧运动,以允许锁定构件83在弹簧92的偏压下从允许缝合器械10击发的位置(即允许致动轴46致动的位置)枢转到阻挡位置,在阻挡位置中锁定门88被容纳在致动轴46中的锁定定位凹槽53中并防止缝合器械10的击发。当一次性装载单元16不存在时传感器连接件182防止击发。当砧座组件20闭合和打开时锁定构件83防止击发。而且,当传感器连接件182向近侧运动时,近侧锁定臂535的近端537用于枢转锁定爪54,使锁定突起55运动脱离腔512,从而允许致动轴46被致动,见图8。
如图4中所示,手柄外壳36可包括环形通道117,环形通道117被构造成容纳在可旋转把手28的近端上形成的环形肋118,可旋转把手28优选由可通过螺钉29相互连接的模制半部28a和28b形成。环形通道117和肋118允许可旋转把手28与手柄外壳36之间的相对旋转。如图4中所示,细长主体14可包括外部壳体124,其大小设置成能够支撑传感器管176(在图10中显示)和关节运动连接件123。组成元件123、124、176和52的这种组合有时在这里被称为“控制杆组件125”,并可包括以类似轴颈方式安装(journal)在控制杆52上的其他元件。壳体124的近端包括在直径上相对的开口128,它们的尺寸设置成容纳在可旋转把手28的远端上形成的径向突起132,见图4和5。突起132和开口128将可旋转把手28和细长主体14在纵向和旋转方向上相对于彼此都固定连接。可旋转把手28相对于手柄组件12的旋转由此导致细长主体14围绕纵向轴线L-L相对于手柄组件12相应地旋转。还应当理解,由于一次性装载单元16、16’与细长主体14的远端连接,细长主体14的旋转还导致一次性装载单元16、16’的旋转。
在各种实施方式中,关节运动机构120可被支撑在可旋转把手28上并包括关节运动杆30和凸轮构件136,见图11。关节运动杆30可围绕枢轴销140枢转安装,该枢轴销可螺纹连接到可旋转把手28上。移位销142可被容纳在关节运动杆30底部中的插口131中,并从其中向下延伸以便与凸轮构件136接合。凸轮构件136可包括外壳144,该外壳144具有穿过其一侧延伸的细长槽146。一对凸轮运动板136a、136b可通过一对铆钉145或者其他合适的紧固件与外壳144连接以形成凸轮运动板组件137。在其他实施方式中,凸轮运动板组件137可与外壳144一体化形成。凸轮运动板136a和136b可分别具有阶梯式凸轮表面148a、148b,阶梯式凸轮表面148a、148b形成阶梯式凸轮表面148。凸轮表面148的每个阶梯与缝合器械10的关节运动的特定程度对应。细长槽146被构造成容纳从关节运动杆30突出的移位销142。凸轮运动板组件137与外壳144连接,以便形成远侧阶梯式部分150和近侧阶梯式部分152。近侧阶梯式部分152包括凹槽154。
如同从图4中看出的那样,关节运动机构120可进一步包括移动构件138,该移动构件具有竖直的臂部分540,该臂部分540中具有尺寸设置成容纳在传感器筒178上形成的片544的切口542。移动构件138的远端可包括臂546,该臂包括被构造成容纳从关节运动连接件123的近端延伸的指状件164的开口548,见图4和10。可由不磨损材料例如构建的销166与移动构件138连接并且其尺寸设置成被容纳在阶梯式凸轮表面148中。在装配状态下,凸轮构件136的远侧和近侧阶梯式部分150和152被定位于在可旋转把手28上形成的凸缘170和172下面,以便将凸轮构件136限制成相对于缝合器械10的纵向轴线“L-L”横向运动。当关节运动杆30围绕枢轴销140枢转时,凸轮构件136在可旋转把手28上横向运动,使阶梯式凸轮表面148相对于销166横向运动,迫使销166沿着阶梯式凸轮表面148向近侧或者远侧运动。由于销166与移动构件138固定连接,移动构件138向近侧或者远侧运动使关节运动连接件123相应地向近侧或远侧运动。
传感器筒178可具有被构造成被容纳在凸轮运动板组件137中的凹槽154内的凸节544部分。当可进行关节运动的一次性装载单元16可操作地连接到缝合器械10的细长主体14的远端时,凸节544在凸轮构件136中的凹槽154中向近侧运动。当凸节544位于凹槽154的近侧时,凸轮构件136自由地横向运动,使缝合器械10进行关节运动。如同在美国专利US5865361中解释的那样,不可进行关节运动的一次性装载单元16’不具有延伸出的插入末端。这样,当不可进行关节运动的一次性装载单元16’被插入到细长主体14中时,传感器筒178不会向近侧运动足够的距离以使凸节544从凹槽154中运动。因此,通过定位在凹槽154中的凸节544防止了凸轮构件136横向运动并且关节运动杆30被锁定在其中央位置中。
如同在图4-9中可以看到的那样,该实施方式还可包括击发锁定超驰(override)组件600,其具有超驰钮601,该超驰钮可具有与其连接的超驰线602。超驰线602可滑动支撑在在内部机架组件510的顶面604上形成的线形保持片606中。超驰线602的远端610被安装在传感器连接件182的远端中的孔539中。当超驰钮601沿着近侧方向“PD”运动时,超驰线602向近侧拉动传感器连接件182,这偏压锁定爪54脱离与致动轴46的锁定接合,并且还引起弹簧臂536的端部538使凸轮表面83a向近侧运动,允许锁定构件83在弹簧92的偏压下从允许缝合器械10击发(即允许致动轴46致动)的位置枢转到阻挡位置,在阻挡位置中锁定门8被容纳在致动轴46中的锁定定位凹槽53中并防止缝合器械10的击发,除非插棒82被按压。
参见图1、2、9和10,为了使用缝合器械10,一次性装载单元16、16’首先与细长主体14的远端连接。缝合器械10可与可进行关节运动的一次性装载单元16和不可进行关节运动的一次性装载单元16’一起使用,装载单元16、16’均具有例如大约30mm至大约60mm之间的线性缝钉排。将一次性装载单元16、16’与细长主体14连接的方法在美国专利No.5865361中公开。当一次性装载单元16、16’的插入末端与传感器管176的远端接合时,一次性装载单元感测机构被致动。当插入末端接合传感器管176并使其向近侧运动时,传感器管176使传感器筒178和传感器连接件182沿着近侧“PD”方向向近侧运动,以便将锁定构件83从非阻挡位置逆时针枢转到其中门88阻挡致动轴46的运动的位置。
当一次性装载单元16、16’与缝合器械10连接时,工具组件17可围绕目标组织定位。为了将目标组织夹钳在缝钉成形砧座20与钉仓组件18之间,可动手柄24抵抗扭转弹簧40的偏压向着固定手柄部分22枢转,将传动爪42运动成与致动轴46的肩部322接合。肩部322与传动爪42之间的接合使致动轴46向远侧行进,并由此使控制杆52向远侧行进。控制杆52以其远端与其中包括驱动梁的一次性装载单元16、16’的轴向驱动组件连接,使控制杆52向远侧的运动使驱动梁沿着远侧方向运动,从而引起缝钉成形砧座20以美国专利No.5865361中描述的方式枢转闭合。在各种实施方式中,可动手柄24的一个完整冲程可使致动轴46行进大约15mm,这在第一次冲程中可足以夹钳组织但不击发缝钉。在可动手柄24由被偏压到致动轴46的底部中的定位凹槽53中的锁定门88释放后,致动轴46被保持在其纵向位置中。当可动手柄24被释放时,由于扭转弹簧40将手柄24恢复到与固定手柄22间隔的位置,驱动爪42在齿条48上运动。在该位置中,传动爪42被促动成与齿条48接合以进一步将致动轴46保持在其纵向固定位置中。
为了“击发”支撑在钉仓组件18中的缝钉(即将缝钉驱动到缝钉成形砧座20中),可动手柄24再次被致动。在各种实施方式中,缝合器械10能够容纳具有大约30mm到大约60mm之间的线性缝钉排的一次性装载单元16、16’。在这种设置中,缝合器械10可被构造成使可动手柄24的每个冲程使致动轴46行进15mm。由于需要一个冲程以夹钳组织,可动手柄24必须被致动(n+1)个冲程来击发缝钉,其中n为与缝合器械10连接的一次性装载单元中的线性缝钉排的长度除以15mm。
在缝钉可被击发之前,击发锁定组件80必须被致动,使锁定门88从其阻挡位置运动到非阻挡位置。这可通过致动插棒82以引起凸轮表面85与锁定构件83的槽89的侧壁接合从而沿着图9中所示的逆时针方向枢转锁定构件83来实现。其后,可动手柄24可被致动合适数目的冲程以行进致动轴46,并由此沿着远侧方向“DD”行进控制杆52和驱动梁,从而以公知的方式击发一次性装载单元16、16’。为了在击发缝钉后回缩致动轴46并由此回缩控制杆52和一次性装载单元16、16’的驱动梁,回缩把手32a、32b可被向近侧拉动,引起销66使释放板64沿着由图7中的箭头“J”示出的方向在齿49上运动,从而使传动爪42从与齿条48的齿49的接合中脱离。
本领域普通技术人员将会理解,一次性装载单元16、16’在使用之前被消毒并被包装到无菌包装材料中。同样地,缝合器械10也可在使用之前被消毒。在一次性装载单元16、16’被使用之后,其可被抛弃。虽然可想到缝合器械10也可被重新消毒以便另外使用,但是那些现有器械诸如在前述美国专利No.5865361中描述的那些和适于与一次性装载单元一起使用的其他已知器械都不能很好地适于简单地拆卸以利于它们的各种内部元件的消毒。因此,所述单元常常在单次使用后被抛弃。如同在下面进一步解释的那样,缝合器械10被构造成方便简单地拆卸以允许缝合器械10再生(即重新被消毒)。
图12示出了已经被使用并且一次性装载单元(未显示)已经从其上拆下之后(图14中的动作700)的缝合器械10。点620、622分别表示细长主体14和手柄组件12上的示例性污染区域。为了开始缝合器械10的再生处理,用户使击发超驰钮601向近侧运动并将超驰钮601保持在该近侧位置(动作702)。所述动作使传感器连接件182以上面描述的方式向近侧运动并允许用户致动致动轴46。用户还使插棒82运动,以便能够使待循环(cycle)的可动手柄24致动该致动轴46。用户然后可重复循环可动手柄(由图13中的箭头“R”表示)以延伸控制杆52,使控制杆52的被污染部分624延伸到壳体124之外(动作704),见图13。用户然后可将控制杆52的暴露的被污染部分624和壳体124的远端插入到合适的清洁或者消毒介质630中,例如诸如插入到环氧乙烷、过氧化物等中(动作706),见图15。
为了对手柄组件12消毒,手柄组件12可以很容易被拆卸(动作708)。再次参见图5,用户可通过除去螺钉或紧固件29分离可旋转把手部分28a和28b(动作710)。可旋转把手部分28a和28b以及移动构件138被除去并被搁置一旁(动作712)。右侧和左侧回缩把手32a、32b然后被从连接杆60上拉离(动作714)。三个快拆紧固件400然后可从左侧外壳部分36上除去-除非紧固件400与其松弛连接(动作716)。手柄外壳部分36b然后可被搁置一旁(动作718)。用户然后可从外壳部分36a提升击发组件500并将其放置到平坦表面上(动作720)。用户然后可握持控制杆52的远端并将其竖直旋转(由图5中的箭头“V”表示-动作722)。控制杆52然后可从致动轴46中的腔47被拉动,如图4中所示(动作724)。用户然后可将传感器筒178从传感器管176的近端上拆下(动作726)。因此,缝合器械10可被分成图4中显示的部件。用户然后可选择所需的清洁/消毒循环(动作730),见图16。特别是,用户可在其中元件被浸泡在合适的清洗液630中(图17)的“湿”清洁循环与其中采用辐射的“干”清洁循环之间进行选择,或者也可采用两种循环的组合。本领域普通技术人员将会认识到,图17仅仅示出了被浸泡在清洗介质630中的手柄组件的一些组成元件。应当理解,希望手柄组件的所有元件都被同时浸泡(如果容器足够大),或者一次浸泡一个,或者以小组浸泡直到所有元件被清洁(动作732)。但是应当理解,已经用坏或者损坏的那些元件可以新的消毒元件替换以完成组装。含有清洗介质630的容器632可被搅动,或者清洗介质可使用常规方法搅拌或者搅动以驱动清洗介质630通过内部机架组件510中的开口511、与保持在其中的所有元件接触(动作734)。在元件已经被暴露到清洗介质630中所需的时间量之后,可将元件从清洗介质630中除去然后在空气中干燥或者利用其他常规方法干燥(动作736)。
在元件已经由清洗介质清洁之后(动作732-736),用户还可选择对元件进行辐射(动作740、742)或者用户可选择不辐射元件(动作744),此时用户可对一些元件进行润滑(动作746,将在下面进一步讨论)。如果在湿清洁元件之后或者代替湿清洁用户选择辐射拆卸的元件,用户可将所有的元件、部件放置到合适的盘或者其他物体(未显示)上。辐射然后可使用常规辐射技术施加到元件上。例如,可采用电子束照射。其他形式的蒸汽消毒介质例如诸如环氧乙烷蒸汽介质、过氧化物蒸汽介质也可被采用。
在元件已经被消毒之后,一些元件可被润滑(动作746)。如同从图18中可以看到的那样,在各种元件中,润滑指令770可被压印或者以其他方式设置在内部机架组件510上。消毒润滑介质例如诸如硬脂酸钠可被应用到各种元件上,如图18中所示。
元件然后可被重新组装,如图19中概述的那样。为了帮助元件的组装,其中具有一系列互补腔792、794的消毒组装构件或者盘790可被采用,见图20。重新组装的一种方法包括动作750,包括将可旋转把手部分28a放置在组装盘790中的互补形状的腔792中。回缩把手32a可被放置在互补腔794中(动作752)。第一外壳部分36a可被放置在互补腔796中(动作754)。移动构件138可被放置到具有与其连接的销166的右侧可旋转把手部分28a中,该销166被插入到安装在右侧可旋转把手部分28a中的凸缘170、172下面的凸轮构件136中的阶梯式凸轮槽148中(动作756)。传感器筒178可被设置在控制杆52的近端上(动作758)。控制杆组件125被竖直定向,并且远端向上。传感器筒178被保持在控制杆52上(动作760)。控制杆52的近端被插入到致动轴46中的腔47中(动作762)。控制杆组件125然后向下旋转到左侧以完成与致动轴46的连接(动作764)。传感器筒178被旋转直到片544向下(动作766)。连接的击发组件500和控制杆组件125被插入到位于组装盘790的相应腔798、792、796中的第一手柄外壳部分36a和右侧可旋转把手部分28a中。传感器筒178上的锁定片544被插入到移动构件138中的切口542中(动作768)。连接杆60可被对准以便插入到右侧回缩把手部分32a中的孔(未显示)中(动作770)。第二手柄外壳部分36b然后设置在组件上方并被对准以便能够使快拆紧固件400将手柄外壳部分36a、36b连接在一起(动作772)。可旋转把手部分28b可被定向以配合可旋转把手部分28a并用螺钉29连接可旋转把手部分28a、28b(动作774)。左侧回缩把手部分32b然后可被压到连接杆60上以完成组装(动作776)。
上面描述的击发锁定组件80以及前述在美国专利No.5865361中公开的击发锁定组件可能难以被使用,因为临床医生必须按压插棒82使致动轴46能够通过循环可动手柄24被致动。所述设置通常要求临床医生使用双手(一个握持在手柄组件上并致动可动手柄,另一个压下插棒82)。更希望如下的外科缝合器械,其具有更具有人机工程学效率的击发锁定扳机设置,该击发锁定扳机设置不需要临床医生使用双手击发器械。图21-33示出了缝合器械810,其采用更容易使用并且不要求双手来击发器械的击发锁定系统880,除此之外,其大体上与上面描述的器械类似,或者可大体上与美国专利No.5865361中描述的缝合器械类似,或者与其他现有外科器械类似。
参见图21和22,手柄组件12包括手柄外壳36,其优选由模制的手柄外壳部分36a和36b形成,两个手柄外壳部分共同形成手柄组件12的固定手柄22和筒状部分26。可动手柄824可围绕枢轴销38枢转支撑在手柄外壳部分36a和36b之间,见图22。可包括扭转弹簧的偏压构件40将可动手柄824偏压远离固定手柄22。致动轴46可被支撑在手柄外壳36的筒状部分26中并包括带齿49的齿条48。具有齿条接合齿43的传动爪42可围绕枢轴销44枢转安装在可动手柄824的一端上。可包括扭转弹簧的偏压构件50可被用来向着致动轴46上的齿条48促动传动爪42。当可动手柄824被致动(例如枢转)时,其运动传动爪42,使齿条接合齿43驱动接合致动轴46的齿条48,从而沿着远侧方向“DD”线性行进致动轴46。致动轴46的前端具有在其中形成的腔47以容纳控制杆52的近端53(图23),使致动轴46的线性行进引起控制杆52的相应线性行进。
缝合器械810可进一步具有锁定爪54,其具有齿条锁定构件55,该齿条锁定构件可围绕枢轴销57枢转安装在手柄外壳36中并通过偏压构件56(也优选为扭转弹簧)向着齿条48偏压。锁定爪54的齿条锁定突起55被定向以便运动到致动轴46中的腔512中,当齿条锁定突起55位于腔512中时,当没有一次性装载单元与缝合器械810连接时使致动轴46被保持在纵向固定位置中。
各种实施方式还可包括回缩机构58,其包括通过连接杆60连接到致动轴46的近端的右回缩器把手32a和左回缩器把手32b,见图22。连接杆60可包括:右接合部分62a和左接合部分62b,以便容纳回缩器把手32a、32b;中央部分62c,该中央部分的尺寸被设置并被构造成分别在致动轴46中靠近致动轴近端处形成的一对纵向槽34a中平移。释放板64可操作地与致动轴46连接并被安装以便响应于回缩器把手32a、32b的操作相对于致动轴运动。一对间隔设置的销66可从致动轴46的侧面向外延伸以接合在释放板64中形成的相应倾斜凸轮槽68。当回缩器把手32a、32b沿着近侧方向“PD”运动时,销66可相对于致动轴46并相对于齿条48向下释放板64,使释放板64的底部部分在齿条48下面延伸,从而使传动爪42的接合齿43从齿条48上脱离。槽70可在释放板64的近端处形成以容纳连接杆60的中央部分62c,并且在手柄组件12的筒状部分26中设置细长槽34,以便在回缩把手32a、32b沿着近侧方向“PD”被拉动以回缩致动轴46并由此向后回缩控制杆52时容纳连接杆60的纵向平移。
缝合器械810可进一步包括传感器连接件882,传感器连接件882可通过延伸穿过传感器连接件882的销或者螺钉530与手柄外壳部分36a滑动连接,使传感器连接件882可相对于手柄外壳36纵向滑动。弹簧531的远端可与螺钉530连接并且弹簧531的近端可钩在传感器连接件882上的钩533上,见图22。弹簧531用于沿着远侧方向“DD”偏压传感器连接件882。传感器连接件882进一步包括近侧锁定臂535,其具有被构造成与锁定爪54相互作用的向内突出的近端537。特别是,当没有一次性装载单元16、16’与器械810连接时,近侧锁定臂535的近端537与锁定爪54脱离,从而将锁定爪54保持在锁定位置中,在该位置中锁定突起55被容纳在腔512中以便将致动轴46保持在纵向固定位置中。因此,当没有一次性装载单元16、16’与器械810连接时,器械810不能被击发。
参见图23,一次性装载单元感测机构可在缝合器械810中从细长主体14延伸到手柄组件12中。感测机构可包括可滑动支撑在外部壳体124中的传感器管176。传感器管176的远端朝着细长主体14的远端定位并且传感器管176的近端通过一对凸节180’连接在传感器筒178’的远端。传感器连接件882的远端被定向成与传感器筒178’的带凸缘的近端190’成抵接关系。
传感器连接件882可进一步具有在其上形成的向下延伸的远侧片534以便与在传感器筒178’上形成的凸缘179接触,见图22和23。如同将在下面进一步讨论的那样,传感器管176被定向以与传感器筒178’连接,见图23。当一次性装载单元16、16’与细长主体14的远端连接时,一次性装载单元16、16’接合传感器管176的远端以向近侧驱动传感器管176,从而向近侧驱动传感器筒178’和传感器连接件882。当传感器连接件882向近侧驱动时,近侧锁定臂535的近端537枢转锁定爪54,使锁定突起55运动脱离腔512,从而允许致动轴46被致动。
缝合器械810还可采用在上面详细描述的类型和构造的关节运动机构120,但具有下面指出的差别。在各种实施方式中,关节运动机构120可被支撑在可旋转把手28上并包括关节运动杆30、凸轮构件136和移动构件138’。在各种实施方式中,移动构件138’可包括多个脊156,脊156被构造成滑动容纳在沿着可旋转把手28的内部形成的槽(未显示)中。脊156与那些槽之间的接合防止可旋转把手28和移动构件138’的相对旋转同时允许相对线性运动。移动构件138’的远端可包括臂160,该臂包括被构造成容纳从关节运动连接件123的近端延伸的指状件164的开口162,见图23。
在组装状态下,凸轮构件136的近侧和远侧阶梯式部分150和152被定位在可旋转把手28上形成的凸缘170和172下面以限制凸轮构件136相对于缝合器械810的纵向轴线“L-L”横向运动。当关节运动杆30围绕枢轴销140枢转时,凸轮构件136在可旋转把手28上横向运动,使阶梯式凸轮表面148(见图11)相对于销166横向运动,迫使销166沿着阶梯式凸轮表面148向近侧或远侧运动。由于销166固定连接到移动构件138’,移动构件138’向近侧或远侧运动以使第一致动连接件123相应地向近侧或远侧运动,见图23和24。
再次参见图24,凸轮构件136可包括凹槽154。具有被构造成容纳在凹槽154中的凸节部分186的锁定环184围绕传感器筒178’定位在控制片部分188’与近侧凸缘部分190’之间,见图23。定位在凸缘部分190’与锁定环184之间的弹簧192’使锁定环184围绕传感器筒178’被向远侧促动。当具有伸出的末端部分的可进行关节运动的一次性装载单元16插入到缝合器械810的细长主体14的远端中时,插入末端引起控制片部分188’向近侧运动成与锁定环184接合,向近侧促动锁定环184和凸轮构件136的凹槽154中的凸节部分186。随着凸节部分186定位在凹槽154近侧,凸轮构件136自由横向运动以使缝合器械810进行关节运动。其他不可进行关节运动的一次性装载单元可不具有伸出的插入末端。这样,当不可进行关节运动的一次性装载单元16与细长主体14连接时,传感器筒178’不向近侧回缩足够的距离以从凹槽154运动凸节部分186。因此,通过定位在凹槽154中的锁定环184的凸节部分186防止了凸轮构件136横向运动并且关节运动杆30被锁定在其中央位置。
参见图23,细长主体14的远端可包括控制杆锁定机构900,其在一次性装载单元16、16’与细长主体14的远端连接过程中可被致动。控制杆锁定机构900可包括阻挡板902,其由弹簧904向远侧偏压并包括具有倾斜凸轮表面908的近侧指状件906。在各种实施方式中,具有从其上突出的锁定片912的击发轴锁定构件910可被采用。锁定片912可被构造成选择性接合控制杆52中的切口914。击发轴锁定构件910可设置有板簧(未显示)形式或者类似物的偏压构件并具有穿过其中延伸的锁定销916。当阻挡板902的近端在远侧位置中向前时板簧用于向外偏压击发轴锁定构件910。阻挡板902可从与锁定片912间隔的远侧位置运动到定位在锁定片912后面的近侧位置。在近侧位置中,阻挡板902引起锁定片912延伸穿过传感器管176中的槽918并与控制杆52中的切口914接合。
在一次性装载单元16、16’插入到细长主体14的远端中时,如同将在下面进一步详细描述的那样,在一次性装载单元16、16’被旋转成与细长主体14接合以向近侧位置促动板902时,阻挡板902的凸轮表面908由一次性装载单元16、16’上的凸节接合。定位在切口914中的锁定片912通过阻挡板902保持,同时凸节接合凸轮表面908以防止组装过程中控制杆52的纵向运动。当一次性装载单元16、16’相对于细长主体14正确定位时,一次性装载单元16、16’的近端上的凸节停止在凸轮表面908上,允许弹簧904将阻挡板902恢复到其远侧位置,从而允许控制杆52随后的纵向运动。应当注意,当一次性装载单元凸节停止于凸轮表面908上时,可产生可听到的“咔哒”声,表明一次性装载单元16、16’被正确紧固到细长主体14上。
现在参见图22、25和26,缝合器械810可采用改进的击发锁定组件880。在该实施方式中,可动手柄824可设置有腔930,其尺寸设置成容纳击发释放扳机932的近侧部分。如同从这些附图中看到的那样,击发释放扳机932可具有在其上形成的凸节934,并且释放弹簧936可在腔930的底部与凸节934之间延伸,沿着“A”方向将偏压力施加到击发释放扳机932。如同特别从图26中看到的那样,击发释放扳机932可具有近侧尾部940,其尺寸设置成当击发释放扳机沿着“B”方向被压缩时滑动延伸到在可动手柄824中形成的槽825中。改进的击发锁定组件880可进一步包括齿轮连接组件950。在各种实施方式中,齿轮连接组件950可包括第一齿轮952,其旋转接收在连接到可动手柄824的第一齿轮销954上。第一齿轮952可具有第一齿轮部分956,其被设置成与在击发释放扳机932的尾部940上形成的释放扳机齿条960啮合。第一齿轮952可通过第一连接器连接件972与释放爪970连接,该第一连接器连接件可枢转销接或以其它方式连接到第一齿轮952和释放爪970。如同从图22和25中可以看到的那样,释放爪970可枢转支撑在销38上。
在各种实施方式中,释放爪970可具有接合部分974,其被构造成接合释放销980,释放销980与第二连接器连接件982连接并被限制成骑设在可动手柄824中形成的弧形槽826中。如同本具体实施方式所描述的那样,显而易见的是,槽826防止由于可动手柄824的致动而使第二连接器连接件982运动。第二连接器连接件982还可枢转销接或者连接到门齿轮990,该门齿轮以轴颈方式可旋转地连接到由手柄外壳部分36a、36b支撑的齿轮销992上。门齿轮990上具有齿轮齿部分994,其被定向以啮合在锁定门996上形成的门齿条998。锁定门996中可具有槽997,槽997适于接收门弹簧1000的部分1002,门弹簧1000支撑在手柄外壳部分36a、36b之间延伸的门销1004上。门弹簧1000用于沿着“C”方向偏压锁定门996,见图26。
下面将参照图27-30描述击发锁定组件880的操作。图27示出了在将组织夹钳到一次性装载单元(未显示)中之前的缝合器械810。如同从该图中看到的那样,在该操作阶段释放爪970的接合部分974不与释放销980接触。还可以看出,锁定门996的上端位于致动轴46的远端。图28示出了可动手柄824的第一次致动以引起一次性装载单元的缝钉成形砧座以上面描述的方式闭合。临床医生还没有压缩击发释放扳机932,并且方便地将他或她的食指放置在击发释放扳机932的致动部分933的后面。通过致动可动手柄824,致动轴46由传动爪42以上面描述的方式沿着远侧方向“DD”被驱动。从图28中可以看出,致动轴46已经运动到其中锁定门996的端部进入到致动轴46中的锁定定位凹槽53和释放板64中的相应锁定定位凹槽53’中。如同在图25中更容易看出的那样,锁定门996的上端具有在其上形成的倒角或者倾斜部分999,其与锁定门996的垂直延伸的近侧1005相交。如同从图25中可以看出的那样,致动轴46中的锁定定位凹槽53具有倾斜表面1006、1007并且还具有垂直凸台1008部分。当锁定门996的上端由门弹簧1000完全被偏压到锁定定位凹槽53中时,锁定门996的近侧1005与致动轴46中的垂直凸台1008成面对关系,从而防止致动轴46的运动。但是,当锁定门996沿着方向“D”被拉动时,倾斜表面1006、1007以及锁定门996上的倒角表面999使致动轴46能够纵向运动经过锁定门996而不使锁定门996必须完全被偏压脱离与致动轴46的接触。
回到图28,当处于该位置时,可动手柄824中的槽826允许可动手柄向着固定手柄部分22被拉动而不引起销980使第二连接器连接件982运动,该第二连接器连接件的运动进而可致动锁定门996。从图28中可以看出,弹簧1000已经将锁定门996偏压到其中锁定门996被容纳在锁定定位凹槽53、53’中并且其近侧表面998与致动轴46中的垂直凸台1008成相对关系的阻挡位置。在可动手柄824已经被拉动到图28中显示的第一位置以闭合缝钉成形砧座时,临床医生然后允许可动手柄824在手柄闭合弹簧40的偏压力作用下运动到图29中所示的位置。在该阶段,如果临床医生希望重新操作工具组件17或者临床医生希望通过将他或她的食指放置到击发释放扳机932的致动部分933上开始击发循环,回缩器把手32a、32b可被向近侧拉动,从而缝钉成形砧座不夹钳组织,如图30所示。
在图31中,临床医生已经压下击发释放扳机932。所述动作引起释放扳机尾部940的释放扳机齿条960与第一齿轮952上的第一齿轮部分956啮合,引起第一齿轮952沿着逆时针方向“CCW”旋转。当第一齿轮952沿着逆时针方向旋转时,其沿着“E”方向推动第一连接器连接件972,引起释放爪970沿着顺时针“C”方向旋转。当释放爪970沿着“C”方向旋转时,接合表面974与释放销980接触并沿着“F”方向拉动第二连接器连接件982。当第二连接器连接件982沿着“F”方向运动时,其引起门齿轮990沿着逆时针方向“CCW”旋转。门齿轮990上的齿轮齿994与门齿条998啮合并沿着“D”方向驱动锁定门996脱离与锁定定位凹槽53、53’的阻挡接合。
图32示出了当致动轴46通过致动可动手柄824开始沿着远侧方向“DD”运动时锁定门996相对于致动轴46的位置。从该图中可以看出,锁定门996的上部倒角部分999现在与致动轴46中的垂直凸台1008接触并允许致动轴46向远侧运动。从该图中可以看出,当致动轴46沿着远侧方向“DD”行进时,锁定门996的上端骑设在致动轴46的底部和板64上。在该冲程期间连接件982的近端已经运动到槽826的近端。
图34示出了替代实施方式的缝合器械810’,其采用替代击发锁定组件880’,除了下面指出的不同之外,该组件可大体上与上面描述的击发锁定组件880相同。特别是,击发锁定组件880’采用柔性杆1020,柔性杆1020被限制成在可动手柄824’中形成的弯曲通道828中运动。柔性杆1020代替了第一齿轮952,第一连接器连接件972和释放爪970。柔性杆1020的一端与第一释放扳机932连接,柔性杆1020的另一端被限制成与释放销980接触,该释放销也被限制成在槽828中运动。因此,当击发释放扳机932被按压时,柔性杆1020推动释放销980,引起第二连接器连接件982沿着“F”方向运动。当第二连接器连接件982沿着“F”方向运动时,门齿轮990沿着逆时针方向“CC”运动并沿着“D”方向驱动锁定门996。当临床医生释放击发释放扳机932时,释放弹簧936沿着“A”方向驱动击发释放扳机932,从而拉动柔性杆1020远离释放销980,由此允许释放销980在槽828中不受限制地运动。当释放销980不受限制时,门弹簧1000被允许沿着“C”方向偏压锁定门996。当锁定门996沿着“C”方向被偏压时,门齿轮990沿着顺时针“C”方向不受限制地被驱动。本领域普通技术人员将会理解,上面描述的击发锁定设置880、880’使临床医生能够单手操作器械。这是对在美国专利No.5865361中描述的那些击发锁定系统和被构造成与一次性装载单元使用的其它现有缝合器械进行的巨大改进。
图35-46示出了外科缝合器械1210,其解决了有关被设计成适应可进行关节运动的一次性装载单元的现有外科缝合器械的至少一部分前述问题。更具体地并参照图35,除了选择性可锁定旋转系统1220和关节运动系统1320(图36,将在下面详细描述)外,外科缝合器械1210可大体上与上面描述的各种器械的构造类似。与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来表示,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。
在一种实施方式中,外科缝合器械1210可包括手柄组件12,其具有可操作地与其连接并从其上向远侧伸出的细长主体14。细长主体14的远端可与可进行关节运动的一次性装载单元16连接。一次性装载单元16可包括工具组件17,该工具组件可通过由细长主体14传递到其上的关节运动(如同已知的那样)选择性地围绕关节运动轴线“A1-A1”进行关节运动,见图35。在本发明的各种实施方式中,细长主体14的近端可与连接到手柄外壳36’上的可旋转护罩1260连接。如同在图36、44和45中看到的那样,手柄外壳36’可包括被构造成容纳在可旋转护罩1260的近端上形成的环形肋1262的环形通道117,该可旋转护罩优选由模制护罩部分1260a和1260b形成。环形通道117和肋1262允许护罩1260与手柄外壳36’之间的相对旋转。可旋转护罩1260的旋转引起细长主体14和与其连接的一次性装载单元围绕由细长主体14限定的纵向轴线“L-L”旋转。外科缝合器械的1210的各种实施方式可包括选择性可锁定旋转系统1220以便选择性锁定可旋转护罩1260,防止其相对于手柄组件12围绕纵向轴线“L-L”旋转(以及防止细长主体4和一次性装载单元16旋转)。
在各种实施方式中,可锁定旋转系统1220可包括在手柄外壳36’的远端上形成或者设置的圆柱形远侧盖1222。图36示出了手柄外壳36’的外壳部分36a’,其具有在其上形成的一个盖部分1222a。本领域普通技术人员将会理解,手柄外壳36’的外壳部分36b’具有在其上形成的配合的盖部分1222b,其与盖部分1222a协同形成远侧盖1222,见图40。
可锁定旋转系统1220可进一步包括制动系统1229。特别是,盖部分1222a可具有内部键条部分1224a并且盖部分1222b可具有内部键条部分1224b。内部键条部分1224a、1224b共同形成内部键条1224,其被构造成支撑制动系统1229的制动管1230。在各种实施方式中,制动管1230具有在其上形成的外部键条1232,其尺寸设置成能够容纳在远侧盖1222中的内部键条1224中,使制动管1230可相对于远侧盖1222轴向运动,但限制成与其一起旋转。制动系统1229可进一步包括制动带1240,其与可操作地支撑在可旋转护罩1260中的制动臂销1250相互作用。制动臂销1250和制动带1240的操作将在下面进一步详细讨论。
制动管1230可通过开关杆(swtitch bar)1270相对于圆柱形远侧盖1222轴向运动,开关杆1270可操作地连接到选择器开关组件1290。从图36中可以看出,开关杆1270具有近端1272和远端1276。近端1272可具有用于容纳选择器开关1292的轴部分1294的孔1274。轴部分1294延伸穿过开关杆1270中的孔1274并通过插销1296销接到其上。另外,选择器开关1292可具有将轴部分1294与外壳36’枢转连接的紧固件销1298。定位弹簧1300可被采用以将选择器开关1292锁定在位置中。定位弹簧1300可具有球状部分1302,当选择器开关1292围绕由紧固件销1292限定的轴线“SA-SA”向远侧和近侧枢转时其适于由插销1296接合,见图36。因此,当选择器开关1292被枢转到近侧位置(图42、43和46)时和当选择器开关1292被枢转到远侧位置(图37、38、41和45)时,弹簧1300的球状部分1302将选择器开关1292和开关杆1270保持在位置中。
再次参见图36,开关杆1270的远端1276可具有从其上突出并适于将开关杆1270连接到制动管1230的连接器销1278,见图38。因此,开关杆沿着近侧方向“PD”和远侧方向“DD”的线性运动引起制动管1230也在圆柱形远侧盖1222部分内沿着那些方向运动。如同从图36-39和41-46中可以看出的那样,开关杆1270的远端1276可进一步具有在其上形成或者与其连接的锁栓1280。锁栓1280适于选择性地啮合旋转锁定环1264,旋转锁定环1264包括一组在环形肋1262上形成或者设置于环形肋1262上的齿1266。从图36中可以看出,圆柱形远侧盖1222中的环形通道117由向内延伸的凸缘1226形成,该凸缘具有穿过其中的槽1228以容纳开关杆1270的远端1276。因此,如同将在下面进一步详细讨论的那样,当开关杆1270沿着远侧方向“DD”运动时,锁栓1280可与护罩1260的旋转锁定环1264的齿1266接合,从而防止护罩1260相对于盖1222和手柄外壳36’旋转,见图44。
外科缝合器械1210的各种实施方式可进一步包括独特新颖的关节运动系统1320,如下面描述的那样,关节运动系统1320与形成细长主体14的元件连接以将关节运动选择性施加于其上,以便传递到一次性装载单元16。关节运动系统1320可包括移动构件138’。例如,移动构件168’可包括多个脊156,它们被构造成滑动容纳在沿着护罩1260的内壁形成的槽1261中。脊156与那些槽1261的接合(图36和37)防止了移动构件138’和护罩1260的相对旋转同时允许那些元件之间的相对线性运动。移动构件138’的远端可包括臂160,臂160包括被构造成容纳从关节运动连接件123的近端延伸的指状件164的开口162,见图37。同样在该实施方式中,移动构件138’具有从其上突出的关节运动销166,关节运动销166延伸穿过关节运动护罩1260中的关节运动槽1265。关节运动销166被容纳在线性关节运动和可旋转把手1322中形成的孔1324(图36)中,该把手1322接收于护罩1260上。关节运动系统可进一步包括线性关节运动和可旋转把手1322,其可由围绕护罩1260连接在一起的两个把手部分1322a、1322b组合而成。如图36所示,可在把手部分1322a中设置孔1324。因此,当临床医生沿着近侧方向“PD”和远侧方向“DD”轴向运动把手1322时,移动构件138’以及关节运动连接件123沿着那些方向运动以使可进行关节运动的一次性装载单元进行关节运动。
同样在该实施方式中,制动系统1229可被构造成防止关节运动系统1320的致动。例如,再次参见图36,带形制动器1240可被构造成被容纳于制动器带槽1269中,制动器带槽1269由在护罩1260的外部上形成的间隔开的肩部凸缘1267形成。从图36中可以看出,制动器带1240没有形成整个环;带形制动器1240的末端1242彼此之间成间隔相向关系,在它们之间限定凸轮容纳开口1244。制动器带1240被安装在制动器带槽1269中,使凸轮开口1242被定向以将制动凸轮1330容纳于其中。连接到制动凸轮1330的是延伸穿过护罩1260中的制动凸轮孔1334的制动臂移位销1332。从图37中可以看出,制动臂移位销1332被构造成被容纳在制动管1230的远端中形成的移位槽1234内。构成一部分关节运动系统1320的线性关节运动和可旋转把手1322中具有底切区域1326,使把手1320相对于护罩1260轴向运动。在各种实施方式中,把手部分1322a可设置有一组定位凹槽1328,它们适于接合从护罩1260上突出的指示器销1263(图41),当把手1320在护罩1260上轴向运动时,当指示器销1263接合定位凹槽1328时指示器销1263发出可听到的咔哒声或者声音。五个定位凹槽1328在该图中示出;其他数目的定位凹槽1328也可被使用。
下面将参照图37-39、41和42-44描述外科缝合器械1210的操作。图37-39示出了处于“旋转”模式的缝合器械1210,其中外部壳体124可围绕纵向轴线“L-L”选择性旋转。从图37和38中可以看出,选择器开关1292被枢转到远侧位置,在该位置中开关杆1270沿着近侧方向“PD”被拉动。当开关杆1270沿着近侧方向被拉动时,旋转锁栓1280从旋转锁定环1264上脱离(图39),从而允许护罩1260围绕纵向轴线“L-L”旋转。如上所述,壳体124的近端包括在直径上相对的开口128,它们的尺寸被设置成接收在护罩1260的远端内侧形成的径向突起132,见图36和38。突起132和开口128可纵向并旋转地固定连接彼此相关的护罩1260和细长主体14两者。护罩1260相对于手柄组件12的旋转由此引起细长主体14围绕纵向轴线L-L相对于手柄组件12相应旋转。而且,由于开关杆1270通过连接器销1278与制动管1230连接,当开关杆1270沿着近侧方向“PD”运动时,制动管1230也在圆柱形远侧盖1222中沿着近侧方向运动。如上面解释的那样,制动凸轮1330的移位销1332被容纳在制动管1230中的移位槽1234中。当制动管1230向近侧运动时,作为进而刚性固定到销1250上的径向臂的远端零件的移位销1332使制动凸轮1330旋转,使其径向向外促动制动器带1240的远端1242,从而将线性关节运动和可旋转把手1322锁定到护罩1260上。制动器带1240防止把手1322在护罩1260上轴向运动;但是,选择器开关1292引起护罩1260围绕轴“L-L”旋转。因此,当选择器开关1292沿着远侧方向被枢转时,细长主体14和与其连接的一次性装载单元可通过可旋转把手1320围绕纵向轴线“L-L”旋转。
当临床医生希望使一次性装载单元进行关节运动时,选择器开关1292沿着图42、43和46中示出的近侧方向“PD”被枢转。从图42、43和46中可以看出,当选择器开关1292被枢转到近侧方向时,开关杆1270沿着远侧方向“DD”轴向行进,将旋转锁栓1280与旋转锁定环1264锁定接合。当锁定锁栓1280与旋转锁定环1264接合时,护罩1260(以及细长主体14和壳体124)不能围绕纵向轴线“L-L”相对于手柄组件12旋转。当开关杆1270沿着远侧方向运动时,制动管1230也沿着远侧方向“D-D”运动,因为开关杆1270与其连接。当制动管1230向近侧运动时,引起移位销1332旋转并旋转制动凸轮1330,使其允许制动器带1240的端部1242彼此相向向内运动,从而允许把手1320相对于护罩1260运动,见图46。在各种实施方式中,关节运动销166从移动构件138’延伸穿过护罩部分1260a中的槽1265并被容纳把手部分1322a中的孔1324中,见图36和37。因此,当临床医生沿着近侧方向“PD”和远侧方向“DD”轴向运动可旋转把手1322时,移动构件138’以及通过臂160与其连接的关节运动连接件123也运动。因此,当临床医生沿着近侧方向“PD”和远侧方向“DD”轴向运动可旋转把手1322时,移动构件138’以及关节运动连接件123也沿着那些方向运动以使可进行关节运动的一次性装载单元进行关节运动。另外,把手1322在护罩1260上轴向运动,当指示器销1263接合定位凹槽1328时指示器销1263发出可听到的咔哒声或者声音为临床医生提供关节运动进程的听觉指示。
图46示出了移动构件138的使用,其具有竖立的臂部540和臂546,臂546包括被构造成容纳从关节运动连接件123的近端(未显示)延伸的指状件(未显示)的开口548,见图4及11。销166与移动构件138连接并且其被设置成延伸穿过护罩1322中的槽1265并进入护罩1322中的孔1324中。该实施方式以与图37和38中示出的实施方式同样的方式工作。本领域普通技术人员将会认识到,前述实施方式代表了对适用于一次性装载单元的现有缝合器械诸如在美国专利No.5865361中描述的那些进行了巨大的改进。特别是,在上面描述的实施方式中,临床医生可将一次性装载单元旋转到所需方向并然后锁定护罩1260,防止护罩1260的进一步旋转。临床医生然后可使一次性装载单元进行关节运动同时将护罩1260保持锁定在位置中。在现有的单元中,可旋转把手自由旋转同时临床医生试图使一次性装载单元进行关节运动。因此,为了防止一次性装载单元旋转,临床医生必须操作关节运动杆同时小心不将旋转运动赋予到可旋转把手。上面描述的实施方式解决了这以问题。
图47-51示出了本发明的另一种外科缝合器械1410,其被构造成用于允许临床医生单手使一次性装载单元进行关节运动并击发该一次性装载单元(未显示)。更特别是并参照图47,外科器械1410大体上类似于上面描述的构造,但关节运动系统1420(将在下面详细描述)除外。与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来标记,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。
在一种实施方式中,外科缝合器械1410可包括手柄组件12,其具有可操作地与其连接并从其上向远侧突出的细长主体14。细长主体14的远端可与可进行关节运动的一次性装载单元16连接。一次性装载单元16可包括工具组件17,该工具组件可通过由细长主体14传递到其上的关节运动(如同已知的那样)选择性地围绕关节运动轴线“AA-AA”进行关节运动。
手柄组件12可包括手柄外壳36并具有可相对于手柄外壳36运动通过致动冲程的与手柄外壳连接的可动手柄。如在上面描述的实施方式中那样,可动手柄24的致动可引起被施加到致动轴46上的纵向致动动作,致动轴46可操作地连接控制杆52,控制杆52包括细长主体14的一部分。从图48-51中可以看出,关节运动系统1420可包括关节运动扳机1422,其被成形并相对于手柄外壳36的固定部分22和可动手柄24定向,使临床医生能够以他或她握持手柄组件12的手的食指致动关节运动扳机1422并致动可动手柄24。扳机1422可具有与其连接的驱动杆部分1424,其具有可通过枢轴销1428枢转销接到手柄外壳36上的垂直部分1426,使关节运动扳机1422可围绕枢轴销1428沿着“G”和“H”方向选择性枢转,见图49。驱动杆部分1424可进一步具有驱动部分1430,其中具有适于容纳与关节运动杆1440连接的驱动销1434的槽1432。从图49中可以看出,关节运动杆1440可设置有一对细长槽1442、1444,它们分别适于容纳螺钉1450、1452的部分。螺钉1450、1452分别延伸穿过细长槽1442、1444,并与手柄外壳部分36连接,使关节运动杆1440被限制为沿着近侧方向“PD”和远侧方向“DD”纵向运动。关节运动杆1440的远端可具有关节运动销1446,其适于延伸到设置在移动构件138”的近端中的环形槽139”中,所述移动构件在结构和操作上可以与在上面相对于移动构件138’描述的相同。移动构件138”可具有多个脊156,其被构造成滑动容纳在沿着可旋转把手28”的内壁形成的槽中。脊156与那些槽之间的接合防止移动构件138”和可旋转把手28”的相对旋转同时允许那些元件之间的相对线性运动。移动构件138”的远端可包括臂160,该臂包括被构造成容纳从关节运动连接件123的近端延伸的指状件164的开口162,见图48和49。因此,当临床医生致动沿着“G”方向致动关节运动扳机1422时,驱动部分1430沿着近侧方向“PD”拉动关节运动杆1440,还沿着近侧方向“PD”拉动与其连接的移动构件138”和关节运动连接件123,由此可引起与其连接的一次性装载单元以上面和下面描述的方式沿着右手方向进行关节运动。当临床医生沿着“H”方向拉动关节运动扳机1422时,驱动部分1430沿着远侧方向“DD”推动关节运动杆1440,还沿着远侧方向“DD”推动与其连接的移动构件138”和关节运动连接件123,由此可引起与其连接的一次性装载单元沿着左手方向进行关节运动。
如上所述,该实施方式可包括传感器筒178’,如上面描述的那样其与传感器管176和传感器连接件182连接,以监测一次性装载单元是否已经与控制杆52连接并防止当没有一次性装载单元与其连接时关节运动机构1420的致动。但是,在该实施方式中,传感器筒178’的凸缘190’被构造成与在关节运动杆1440上形成的“没有重新加载”锁定斜面1448相互作用,见图50和51。当没有一次性装载单元与细长元件14和控制杆52连接时,传感器筒178’被偏压到图50中示出的位置中。从该图中可以看出,在关节运动杆1440上没有重新加载的锁定斜面1448与传感器筒178’上的凸缘190’接合,使关节运动杆1440被沿着“I”方向侧向向外偏压。从该图中还可以看出,向内延伸的锁定定位凹槽37在手柄外壳部分36a上形成,并且当凸缘190’与无重新加载的锁定斜面1448接合以沿着“I”方向偏压关节运动杆1440时适于被容纳在关节运动杆1440中的锁定切口1445中。当定位凹槽37被容纳在锁定切口1445中时,关节运动杆1440不能被致动。因此,当没有一次性装载单元与器械1410连接时,关节运动扳机1422不能被致动。当一次性装载单元与细长元件14和控制杆52以及传感器杆176连接时,传感器筒178’沿着近侧方向“PD”被偏压,引起凸缘190’与非重新加载锁定斜面1448脱离,如图51中所示,从而允许关节运动杆1440运动。因此,当一次性装载单元已经与缝合器械1410连接时关节运动扳机1422可被致动。
本领域普通技术人员将会理解上面描述的关节运动机构1420使临床医生能够单手操作器械。这表示对在美国专利No.5865361中描述的那些击发锁定系统和被构造成用于一次性装载单元的其它现有缝合器械进行了巨大的改进。
图52-64公开了本发明的另一种外科缝合器械1510,其被构造成用于可进行关节运动的一次性装载单元(未显示),该单元允许临床医生通过操作可动手柄24”使一次性装载单元进行关节运动并击发。在一种实施方式中,外科缝合器械1510可包括手柄组件12,其具有可操作地与手柄组件12连接并从其上向远端突出的细长主体14。细长主体14的远端可与进行关节运动的一次性装载单元16连接。一次性装载单元16可包括工具组件17,该工具组件可通过由细长主体14传递到其上的关节运动(如同已知的那样)选择性地围绕关节运动轴线“A1-A1”进行关节运动。如同将在下面详细讨论的那样,外科缝合器械1510可采用与可动手柄24”、致动轴46和关节运动系统1520连接的独特新颖的选择器装置1512。当选择器装置1512处于“击发”朝向时,可动手柄24”经过致动冲程的操作将击发运动赋予致动轴46,并且当选择器装置1512处于“关节运动”朝向时,可动手柄24”经过致动冲程的操作致动关节运动系统1520。与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来标记,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。
从图52和53中可以看出,选择器装置1512可包括关节运动选择器开关1522,其被定位在手柄外壳36之外以便为其提供进口。关节运动选择器开关1522可与关节运动选择器开关轴1524连接,开关轴1524延伸穿过手柄外壳部分36b并与构成关节运动系统1520的一部分的摇杆固定架1530连接。第二关节运动选择器开关轴1526从摇杆固定架1530的另一侧向外突出以延伸穿过手柄外壳部分36a以便连接选择器开关1522a,使摇杆固定架1530可围绕由轴1524、1526限定的摇杆轴线“RA”枢转,见图60。从图56-58中可以看出,关节运动系统1520进一步包括第一关节运动齿轮1540和第二关节运动齿轮1550,它们每个都在摇杆固定架1530中自由旋转。第一和第二关节运动齿轮1540和1550被定向以便选择性接合关节运动杆延伸件1441’,该延伸件构成关节运动杆1440’的一部分,关节运动杆1440’与上面描述的关节运动杆1440类似。从图55中可以看出,关节运动杆延伸件1441’中具有一组孔1443’,它们适于由第一和第二关节运动齿轮1540、1550接合,这取决于摇杆固定架1530的朝向。
选择器设置1512可进一步包括独特新颖的齿轮选择器开关组件1560以便连接在击发齿轮1610与构成关节运动系统的一部分的关节运动传递齿轮传动链1600之间。在各种实施方式中,关节运动传递齿轮传动链1600可包括第一传递齿轮1602和第二传递齿轮1606,该第一传递齿轮1602安装在可旋转支撑在手柄外壳部分36a、36b中的插孔(未显示)中的第一传递齿轮轴1604上,该第二传递齿轮1606安装在可旋转支撑在手柄外壳部分36a、36b中的插孔(未显示)中的第二传递齿轮轴1608。在各种实施方式中,齿轮选择器开关组件1560可包括功能选择器开关1562,其具有一对从其上突出的销1563,所述销延伸穿过手柄外壳部分36b中的相应弧形槽1564并与驱动盘1566连接,见图61和62。从那些图中可以看出,驱动盘1566中可具有一系列齿容纳腔1568,它们适于选择性接合移位盘1570中的相应盘齿1571。移位盘1570可以非旋转地固定到固定轴1574上。从图61和62中还可以看出,固定轴1574的端部1575可被容纳在腔1577中并通过锁定销1578销接于其上。在各种实施方式中,例如,端部1575可模制到手柄外壳部分36a中,使固定轴1574不相对于其旋转。从图62中还可以看出,移位盘1570可通过延伸穿过固定轴1574中的横槽1576的移位销1580不旋转地销接到固定轴1574上,使移位盘1570在固定轴1574上轴向(并不旋转)运动。
从图61和62中还可以看出,齿轮选择器开关组件1560可进一步包括驱动齿轮组件1590,该驱动齿轮组件包括驱动齿轮部分1592和关节运动驱动齿轮部分1594。驱动齿轮组件1590被构造成在固定轴1574上轴向运动并由以类似轴颈方式安装在固定轴1574上的弹簧沿着“J”方向偏压。
现在将参照图57和58描述关节运动系统1520的操作。为了开始关节运动过程,临床医生可致动其中一个关节运动选择器开关1522a、1522b。在一种实施方式中,例如,如果临床医生需要使一次性装载单元向右进行关节运动,则临床医生向下(图52中的箭头“L”)枢转关节运动选择器开关1522a、1522b。通过向下枢转选择器开关1522,摇杆固定架1530沿着图58中的逆时针方向“CCW”枢转,使第二关节运动齿轮1550与关节运动杆延伸件1441’中的孔1443’啮合。在关节运动模式下,允许齿轮选择器开关组件1560保持在图59和63中示出的未致动位置。当处于该位置中时,驱动齿轮组件1590被定位成,使与可动手柄24连接或模制到可动手柄24上的手柄齿轮1620与驱动齿轮组件1590的驱动齿轮部分1592啮合。另外,驱动齿轮组件1590的关节运动驱动齿轮部分1594与第一传递齿轮1602啮合。从图59中可以看出,当驱动齿轮组件1590以该方式定位时,旋转支撑在击发齿轮轴1612上的击发齿轮1610不与驱动齿轮组件1590接合。因此,可动手柄24的致动将不影响击发齿轮1610。
当选择器开关1522a、1522b、1562以上面刚刚描述的方式定位时,临床医生可通过致动(棘齿运动或枢转)可动手柄24使与缝合器械1510连接的一次性装载单元进行关节运动。当可动手柄24被致动时,手柄齿轮1620沿着逆时针方向“CCW”旋转,进而引起第一传递齿轮1602沿着逆时针方向“CCW”旋转,进而引起第二关节运动齿轮1550沿着逆时针方向“CCW”旋转,进而沿着近侧方向“PD”驱动关节运动杆延伸件1441’,见图58。当关节运动杆延伸件1441’沿着近侧方向“PD”被驱动时,关节运动杆1440’驱动移动构件138”,并且与其连接的关节运动连接件123沿着近侧方向“PD”被拉动,可由此引起与其连接的一次性装载单元以上面和下面描述的方式沿着右手方向进行关节运动。为了使一次性装载单元向左进行关节运动,临床医生沿着向上的方向(图52中的“M”方向)枢转关节运动选择器开关1522a、1522b。当选择器开关1522a、1522b沿着该方向枢转时,关节运动齿条1530围绕齿条轴线“RA”沿着顺时针方向“CW”枢转,从而将第一关节运动齿轮1540与关节运动杆延伸件1441’啮合。由于第一关节运动齿轮1540沿着顺时针方向“CW”旋转,当可动手柄被致动时,第一关节运动齿轮1540沿着远侧方向“DD”驱动关节运动杆延伸件1441’。当关节运动杆延伸件1441’沿着远侧方向“DD”被驱动时,关节运动杆1440’沿着远侧方向“DD”驱动移动构件138”以及与其连接的关节运动连接件123,由此可引起与其连接的一次性装载单元沿着左手方向进行关节运动。同样在本实施方式中,关节运动杆1440’可采用上面参照关节运动杆1440描述的锁定设置,以便当没有一次性装载单元与缝合器械1510连接时防止关节运动杆1440’的运动。因此,在该实施方式中,关节运动通过致动可动手柄24产生。
该实施方式还可采用总体标记为1601的独特新颖的击发系统,击发齿轮1610作为其一个部件。更具体地并参照图55-60,击发组件1601还可包括可运动支撑在右侧外壳部分36a中形成的右侧齿条引导件1630a和在左侧外壳部分36b中形成的左侧齿条引导件1630b中的爪滑块1640,如图54中所示(为清楚起见外壳部分36a、36b已经在图54中被省去)。在各种实施方式中,爪滑块1640一般可具有大写字母“I”的形状,其具有远侧横杆部分1642、中间杆部分1644和近侧横杆部分1646.横杆部分1642、1646用于将爪滑块1640滑动支撑在齿条引导件1630a、1630b中,使爪滑块1640能够沿着近侧方向“PD”和远侧方向“DD”轴向运动。同样在该实施方式中,驱动齿条1650可在爪滑块1640的中间杆部分1644的底部上形成或者与其底部连接。击发齿条1650被定向成与击发齿轮1610啮合(将在下面进一步详细讨论)。爪42还与中间杆部分1644连接,并具有齿条接合部分43以便驱动接合致动轴46上的齿条48。如图55和64所示,在各种实施方式中,爪42可由金属冲压而成并形成大体上为U形形状,使爪42可通过枢轴销44’枢转销接到中间杆部分1644。爪弹簧50’可支撑在中间杆部分1644的孔1645中,将爪42偏压成与致动轴46上的齿条48接合。见图64。
下面将参照图60和64描述击发系统1601的操作。为了开始击发过程,临床医生将齿轮选择器开关组件1560转动到图64中示出的位置,使驱动齿轮组件1590沿着“K”方向被偏压,使手柄齿轮1620保持与驱动齿轮1592啮合并且驱动齿轮组件1590的关节运动齿轮1594不与第一关节运动传递齿轮1602啮合。另外,驱动齿轮1592与击发齿轮1610啮合,如上所述,该击发齿轮与击发齿条1650啮合。由于关节运动驱动齿轮1594不与第一关节运动传递齿轮1602啮合,可动手柄24”的致动将不导致任何关节运动的产生。
当选择器开关1562以上面刚刚描述的方式定位时,临床医生可击发致动轴46,进而将击发运动传递到与致动轴46连接的控制杆52,进而以美国专利No.5865361中描述的方式将击发运动传递到与其连接的一次性装载单元。如图56中所示,该独特新颖的实施方式的致动轴46通过致动(棘齿运动或枢转)可动手柄24被击发(或者沿着远侧方向“DD”运动)。当可动手柄24”被致动时,手柄齿轮1620沿着逆时针方向“CCW”旋转,进而引起驱动齿轮1592沿着逆时针方向“CCW”旋转,进而引起击发齿轮1610沿着逆时针方向“CCW”旋转,并沿着远侧方向“DD”驱动击发齿条1650以及与其连接的爪42。爪42的齿条接合部分43与致动轴46上的齿条48的齿49接合,由此沿着远侧方向“DD”驱动致动轴46。该实施方式可以上面描述的方式操作。特别是,临床医生可继续使可动手柄24”进行棘齿运动,直到击发程序完成。当可动手柄24”被枢转到与固定手柄部分22相邻的位置时,临床医生释放可动手柄24”并且可动手柄24”通过弹簧40(见上面的描述)被枢转到开始位置,然后可动手柄24”可再次被枢转用于另一个冲程以便使爪42和致动轴46行进.当可动手柄24”被释放时,当爪沿着近侧方向“PD”运动时爪42的齿条接合齿43在致动轴齿条48上的齿49上方滑动,然后当可动手柄12被枢转以便沿着远侧方向“DD”驱动致动轴时重新接合齿49。
本领域普通技术人员将会理解,缝合器械1510可装备有可动手柄12,其可被用于击发器械并使与其连接的一次性装载单元进行关节运动。还应当理解,所述实施方式能够产生比另一种现有装置诸如在美国专利No.5865361中公开的那些更大的关节运动力。
图65-69示出了用于轴向行进移动构件138并最终导致关节运动连接件(在图65中未显示)的纵向致动的替代关节运动机构1720。从图65和66中可以看出,关节运动机构1720可与可旋转把手28’结合使用,该可旋转把手大体上可与上面描述的可旋转把手28相同,但可旋转把手28’被构造成支撑关节运动把手1730,如图所示。从图66中可以看出,关节运动把手1730可包括拇指片1732,其与延伸穿过可旋转把手部分28a’中的孔1736的枢轴1734连接。枢轴1734可具有方形部分1735,其适于非旋转地容纳在凸轮盘1750中的相应方孔1752中。移动构件138可具有竖立的臂部分540,该臂部分中具有切口542,其尺寸被设置成容纳在传感器筒(未显示)上形成的片,如上面描述的那样。移动构件138的远端可包括臂546,该臂包括被构造成容纳从关节运动连接件123的近端延伸的指状件164(在图65和66中未显示)的开口548,如上面描述的那样,见图4和11。可由非磨损材料例如或涂敷了的金属构成的销166与移动构件138连接,其尺寸被设置成被容纳在弧形凸轮槽1754中。因此,当致动把手1730旋转时,销166沿着近侧方向“PD”和远侧方向“DD”被纵向驱动,这取决于其中致动把手1730旋转的方向。销166的纵向位移在一系列附图67-69中示出。例如,图67示出了当一次性装载单元已经向左侧进行关节运动时凸轮盘1750的位置。图68示出了当一次性装载单元没有进行关节运动时(例如与细长主体轴向对准)的凸轮盘1750和关节运动销166,图69示出了当一次性装载单元已经向右侧进行关节运动时凸轮盘1750和关节运动销的位置。在一些实施方式中,弧形凸轮槽1754的形状设置成使在整个致动序列中其相对于销166的倾角相当小(在15度以内),这可导致有效地关节运动锁定。
图70和71示出了独特新颖的关节运动机构1820和可与可采用一次性装载单元的缝合器械1810结合使用的独特新颖的可锁定旋转系统1850。关节运动机构1820被构造成轴向行进移动构件138并最终导致与移动构件138连接的关节运动连接件123(在图70和71中未显示)的纵向致动。从图70和71中可以看出,关节运动机构1820可与由手柄部分(手柄部分36a”在图70和71中显示,其被理解为形状适于与手柄部分36”配合的另一种手柄部分被采用来形成手柄外壳36”)形成的手柄外壳36”结合使用。在各种实施方式中,关节运动机构1820被安装到可旋转护罩1830上,该护罩1830具有带凸缘的近端1832,其适于被容纳在手柄外壳36”中形成的环形槽1834中,使可旋转护罩1830可围绕轴线“L-L”相对于手柄外壳36”选择性旋转(将在下面详细讨论)。虽然在图70和71中未显示,但上面结合其他实施方式描述的细长元件14和壳体124可通过在可旋转护罩1830的远端上形成的径向突起132与可旋转护罩1830连接。见图70。壳体124中的突起132和开口128将可旋转护罩1830和细长主体14相对于彼此纵向并可旋转地固定连接。可旋转护罩1830相对于手柄外壳36”的旋转由此导致细长主体14相对于手柄外壳36”的相应旋转。
从图70和71可以看出,关节运动机构1820可包括关节运动环1822,其与设置在可旋转护罩1830上的一系列螺纹1836螺纹连接。移动构件138可具有竖立的臂部分540,该臂部分中具有切口542,其尺寸被设置成容纳在传感器筒(未显示)上形成的片(未显示),如上面描述的那样。移动构件138的远端可包括臂546,该臂包括被构造成容纳从关节运动连接件123(在图70和71中未显示)的近端延伸的指状件164(在图70和71中未显示)的开口548,如上面描述的那样,见图4和11。可由非磨损材料例如或涂敷了的金属构成的销166与移动构件138连接,其尺寸被设置成被容纳在关节运动环1822中形成的环形槽1825中。因此,当关节运动环1822在可旋转护罩1830上沿着近侧方向“PD”螺纹行进时,销166也沿着近侧方向“PD”驱动移动构件138(以及关节运动连接件123),引起一次性装载单元沿着右侧方向进行关节运动。同样地,当关节运动环1822在可旋转护罩1830上沿着远侧方向“DD”螺纹行进时,销166也沿着远侧方向“DD”驱动移动构件138(以及关节运动连接件123),引起一次性装载单元沿着左侧方向进行关节运动。
图70和71中示出的实施方式还具有独特新颖的可锁定旋转系统1850,其可包括可锁定把手1852,该可锁定把手由两个把手部分1852a构成,它们通过螺钉、胶水、扣合零件、柱等在手柄外壳36”的远端上方连接在一起,使可锁定把手1852旋转并轴向支撑在手柄组件36”的远端上。从图70和71还可以看出,手柄外壳36”的远端具有第一锁定凸缘1860,其上形成第一组径向齿轮齿1862。可锁定把手1852还可具有向内延伸的第二锁定凸缘1854,其上形成第二组径向齿轮齿1856。第二组径向齿轮齿1856与第一锁定凸缘1860上的第一组径向齿轮齿1862成相向关系,使第二径向齿轮齿1856可选择性地与第一径向齿轮齿1862啮合。锁定弹簧1870可被用于沿着远侧方向“DD”偏压可锁定把手1852,使第二组径向齿轮齿1856与第一组径向齿轮齿1862啮合。从图70和71中还可以看出,可旋转护罩1830的近端1831具有在其上形成的旋转键条1837,其被构造成与在可锁定把手1852的远端上形成的向内延伸的带齿凸缘1858啮合。本领域普通技术人员将会理解,旋转键条1837和带齿凸缘1858用于将可旋转把手1852旋转固定到可旋转护罩1830上同时使可锁定把手1852相对于可旋转护罩1830轴向运动。因此,为了使可旋转护罩1830旋转(并使细长主体14以及固定于其上的一次性装载单元旋转),临床医生沿着近侧方向“DD”偏压可锁定把手1852,使第二组径向齿轮齿1856与第一组径向齿轮齿1862脱离,从而允许可锁定把手1852相对于手柄外壳36”围绕纵向轴线“L-L”旋转。当可锁定把手1852旋转时,可旋转护罩1830通过接合在带齿凸缘1858与旋转键条1837之间也随着可锁定把手1852一起旋转。在临床医生将可旋转护罩1830旋转到所需位置时,他或她然后释放可锁定把手1852。当可锁定把手1852被释放时,弹簧1870将第二组径向齿轮齿1856偏压成与第一组径向齿轮齿1862啮合,将可旋转护罩1830保持在该位置中。因此,所述独特新颖的设置解决了与在与一次性装载单元结合使用的现有外科器械中采用的可旋转把手及关节运动机构有关的问题。特别是,在一次性装载单元和细长主体已经被插入到患者体内之后,临床医生可相对于手柄组件12”围绕纵向轴线“L-L”将一次性装载单元旋转到所需朝向然后将其锁定在该位置中。此后,临床医生可使一次性装载单元向纵向轴线的左侧或右侧进行关节运动。在上面刚刚描述的实施方式中,关节运动环与可旋转把手之间的螺纹接合用于将一次性装载单元锁定在所需的关节运动位置中。如上所指,在采用具有固定到其上的关节运动把手的可旋转把手的现有外科器械中,当临床医生致动关节运动杆时可旋转把手可运动,使其难以精确地定位一次性装载单元。
图72和73示出了另一种独特新颖的关节运动机构1920,其被安装在上面描述的构造和操作类型的可旋转把手28”中。在该实施方式中,关节运动机构1920可包括外关节运动环1922,其具有在其上形成的止推凸缘1924,该凸缘被构造成容纳在可旋转把手28”中形成的环形槽1930中,以便旋转支撑可旋转把手28”中的外关节运动环1922,使外关节运动环1922相对于可旋转把手28”自由旋转但不相对于其轴向运动。在各种实施方式中,外关节运动环1922的近端1923可具有在其上形成的径向齿轮齿1926以便与连接到关节运动把手1942的正齿轮1940啮合。从图73中可以看出,关节运动把手1942具有与其连接的轴1944,其被旋转容纳在可旋转把手28”中的通孔1943中,并与正齿轮1940非旋转连接,使关节运动把手1942的旋转引起正齿轮1940旋转。当正齿轮1940旋转时,外关节运动环1922也围绕纵向轴线“L-L”旋转。本领域普通技术人员将会理解,外关节运动环1922可选择性地围绕纵向轴线“L-L”沿着顺时针方向“CW”或逆时针方向“CCW”旋转,这取决于关节运动把手1942的旋转方向。
从图72中还可以看出,外关节运动环1922具有在其中形成的内螺纹1928以便与内关节运动环1950螺纹接合。在该实施方式中,移动构件包括金属连接件1960,其通过销1952或者其他紧固装置与内关节运动环1950连接或者销接。金属连接件1960被限制成仅仅沿着近侧方向“PD”或远侧方向“DD”轴向运动,因为其被容纳在可旋转把手28”中形成的轴向槽1962中。金属连接件1960的远端包括开口1964,其被构造成容纳从关节运动连接件123的近端伸出的指状件164。因此,关节运动把手1942的旋转可导致关节运动连接件123沿着近侧方向“PD”或远侧方向“DD”轴向运动,这取决于关节运动把手1942的旋转方向。如上面讨论的那样,当关节运动连接件123沿着远侧方向“DD”行进时,其将导致一次性装载单元向左进行关节运动,当关节运动连接件123沿着近侧方向“PD”被拉动时,其将导致一次性装载单元向右进行关节运动。本领域普通技术人员将会理解,内关节运动环1950与外关节运动环1922之间的螺纹连接可用于将关节运动连接件保持在所需关节运动位置(并最终保持一次性装载单元),直到关节运动把手再次旋转。还应当理解,所需的把手旋转由齿轮比和螺距设定。
图74和75示出了另一种替代的关节运动机构1920’,其采用与上面描述的关节运动环1922相同的内关节运动环1922’,但关节运动环1922’中具有凸轮槽1970,而不是内螺纹1928。从图74和75中可以看出,金属连接件1960具有与其连接并骑设在内关节运动环1922’中的凸轮槽1970中的关节运动销1966。因此,内关节运动环1922’通过关节运动把手1924旋转(见上面的描述),凸轮槽1970和容纳在其中的关节运动销1966沿着近侧方向“PD”和远侧方向“DD”驱动金属连接件1960,但只关节运动连接件123沿着那些方向轴向运动(见上面的描述)。
当使用适用于一次性装载单元的现有外科缝合装置时,常常是控制杆因疏忽而在一次性装载单元连接之前就行进到细长主体的外壳的末端之外。当这种情况发生并且一次性装载单元与器械连接时,重新加载的单元不能被击发。作为替代,临床医生在连接重新加载的单元之前必须首先回缩控制杆。这种情况可产生混乱并导致手术过程中不必要的停止时间。另外,在击发程序中,击发杆可能被卡住,要求临床医生回缩击发杆,由于卡住的性质,这有时候很困难。本发明的外科缝合器械2010的实施方式解决了所述问题。
更具体并参见图76,外科缝合器械2010在构造方面可大体上与上面描述的各种器械类似,下面将详细讨论其独特新颖的回缩系统。与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来标记,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。
在一种实施方式中,外科缝合器械2010可包括手柄组件2012,其具有可操作地与手柄组件2012连接并从其上向远端突出的细长主体14。细长主体14的远端可与可进行关节运动的一次性装载单元16(或者不可进行关节运动的一次性装载单元)连接。一次性装载单元16可包括工具组件17,该工具组件可通过由细长主体14传递到其上的关节运动(如同已知的那样)选择性地围绕关节运动轴线“A1-A1”进行关节运动,见图76。在各种实施方式中,细长主体14的近端可与连接到手柄外壳2036上的可旋转把手28连接。如从图76和77中看到的那样,手柄外壳2036可由连接在一起的右外壳部分2036a和左外壳部分2036b形成。
如图76-78中显示的那样,右侧外壳部分2036a可具有可拆卸的盖2040,其通过插入到凸台中的卡扣件、螺钉、销插件或者可释放定位柱与右外壳部分2036a连接。如同将在下面进一步详细讨论的那样,该实施方式也采用上面描述的类型和构造的释放板64(图81),其具有与其连接的连接杆60。连接杆60延伸穿过左外壳部分2036b中的细长回缩槽34b(图76)并穿过可拆卸盖2040中的细长回缩槽34a(图77),使回缩器把手32a、32b与其连接(见上面的描述)。右外壳部分2036a进一步具有在其中形成的回缩槽34a’,当可拆卸盖2040通过卡扣件、粘合剂、螺钉等与右外壳部分2036a连接时,该回缩槽34a’与可拆卸盖2040中的回缩槽34a对应。在该实施方式中,右外壳部分2036a可具有在其中形成的一对间隔设置的细长引导肋2050,它们用于在它们之间限定细长回缩通道2052。同样在各种实施方式中,回缩滑动构件2060可被容纳在连接杆60中并被限制为在细长回缩通道2052中沿着远侧方向“DD”和近侧方向“PD”轴向运动。回缩系统2020可进一步包括索滑块2070,其也被限制成在回缩通道2052中纵向运动,如图79和84-86所示。索滑块2070的近端2072中可具有切口2074,使回缩索2080的近端2072可被销接或者与其连接。回缩索2080的远端2084可与回缩弹簧2090的近端2092连接。回缩弹簧2090的远端2094可与在右外壳部分2036a上形成的回缩弹簧柱2096连接。见图78和83-85。回缩索2080和回缩滑轮2100以类似轴颈方式安装,该滑轮可旋转地支撑在右外壳部分2036a上形成的滑轮柱2102上。
在各种实施方式中,回缩系统2020可被构造成使控制杆52能够在击发程序结束时自动回缩,或者在需要时手动回缩。例如,从图83中可以看出,扳起凸片(cocking lug)2110中可具有空腔2111并通过马蹄形凸片固定架2112和被容纳在空腔2111中的销2114与索滑块2070连接。从图83中可以看出,扳起凸片2110可进一步具有被设置成与可拆卸盖2040相邻的内端部分2116,并且还可具有在其中形成的凹口或切口2118。如图78中所示被构造的凸片弹簧2120可以类似轴颈方式安装在销2114上,以便围绕销2114沿着如图83所示的逆时针方向“CCW”偏压扳起凸片2110。回缩系统2020还可包括回缩锁定组件2130。
回缩锁定组件2130可包括锁定构件2132,其通过锁定销2134可枢转销接到可拆卸盖2040。被构造成如图82和83中显示的锁定弹簧2140可以类似轴颈方式安装在锁定销2134上并通过螺钉2142或者其他合适的紧固件与盖2040连接,使锁定弹簧2140沿着图83中所示的逆时针方向“CCW”被偏压。从图83中可进一步看出,锁定构件2132被构造成经过盖2040中的窗口2044突出并具有适于接合盖2040中的切口2046的带切口端部2136,见图83。锁定构件2132可具有远端2138,其适于制动接合索滑块2070的近端2070中的切口2076。
现在将参照图84-88描述外科缝合器械2010的操作。图84示出了处于初始“预击发”位置中的外科缝合器械2010,其中回缩把手部分32a和扳起把手(cocking knob)2110(图80)处于定位在手柄外壳2036的近端处的“预击发”位置中。在开始击发程序之前,临床医生可沿着远侧方向“DD”将扳起凸片2110推到图85中所示的扳起位置。从该图中可以看出,当扳起凸片2110处于扳起位置中时,回缩弹簧2090被拉伸并用于将回缩能储存于其中。在扳起凸片2110已经运动到扳起位置时,临床医生可按压击发钮82(见上面的讨论),然后通过使可动手柄24进行棘齿运动开始击发程序。当临床医生通过使可动手柄24进行棘齿运动开始行进致动轴46时,回缩把手32a、32b随着致动轴46一起向远侧运动,直到它们在击发冲程结束之前(即控制杆52已经行进到其可沿着远侧方向行进的最远处,引起一次性重新加载单元完全被击发)到达图86中显示的位置。如果临床医生希望在到达最终击发冲程之前(在击发程序的任意时刻)手动回缩控制杆52,临床医生简单地沿着图87中所示的顺时针方向“CW”偏压扳起凸片2110,引起扳起凸片2110沿着顺时针方向“CW”偏压锁定构件2132,从而引起远端2138运动脱离索滑块2070中的锁定切口2076,从而允许索滑块2070在回缩弹簧2090的力的作用下沿着近侧方向“PD”运动,由此沿着近侧方向“PD”促动回缩滑块2060。由于回缩杆60延伸穿过回缩滑块2060并与回缩板64连接,回缩杆60引起回缩板64借助其与致动轴46的连接回缩致动轴46(和控制杆52)。
如果临床医生不希望手动致动回缩系统2020,临床医生可保持可动手柄24进行棘齿运动,直到击发程序完成。当击发程序完成时致动轴46已经向远侧行进到其最远侧位置时,(图88)回缩滑块2060将锁定构件2132偏压到图88中显示的位置中,使远端2138运动脱离与索滑块2070中的切口2076的制动接合,允许索滑块2070在回缩弹簧2090的力的作用下运动到最近侧回缩位置。因此,当回缩把手32a到达完全击发位置时,其引起回缩系统2020自动回缩致动轴46和控制杆52。
本领域普通技术人员很容易理解这些实施方式用于避免控制杆52没有完全被回缩到其中另一个一次性重新加载单元可与缝合器械连接的位置。另外,如果在击发程序中需要的话,回缩弹簧用于帮助外科医生回缩控制杆。
图89示出了作为替代的一次性装载单元2216,其具有细长外壳部分250’,该细长外壳部分可包括上半个外壳(未显示)和下半个外壳252’。外壳250’的远端与工具组件17连接(图760并且可拆卸地连接到细长主体14。上和下半个外壳限定了用于将轴向驱动组件212滑动容纳在其中的通道1253’。如同将在下面进一步讨论的那样,驱动组件212包括细长驱动梁266,该驱动梁包括远侧工作头268和近侧接合部分270。驱动梁266可由单片材料制成,或者优选由多个片层构成。接合部分270可包括一对接合指状件270a和270b,它们的尺寸可被设置并构造成可固定地接合在驱动构件272中形成的一对相应固位槽272a。驱动构件272可包括近侧孔口274,其被构造成当一次性装载单元的近端与外科缝合器械10的细长主体14接合时容纳控制杆52的远端。在该实施方式中,至少一个,优选一对能量存储元件2220也被支撑在外壳250’中,如图所示。能量存储元件2220可包括压缩弹簧2222。当控制杆52沿着远侧方向“DD”轴向行进时,驱动构件272和驱动梁266沿着该方向被驱动压缩弹簧2222(即将回缩能存储在其中)。在击发程序已经完成后或者如果在击发程序期间其变得需要回缩驱动梁266,被压缩的弹簧2222可释放储存的回缩能并通过释放它们存储的能量沿着近侧方向“PD”偏压驱动梁266和驱动构件272用于帮助回缩过程。
现有器械诸如在美国专利No.5865361中公开的那些受到由于施加到击发系统上的增加的负载而不能在较厚的组织(例如具有3.5mm以上厚度的组织)中被击发的困扰。所述增加的负载例如当刀仍然位于砧座中并因此可要求端部执行器切割组织时可增加击发系统将出现故障的可能性。所述故障模式可具有严重的患者伤害后果。本发明的各种实施方式涉及改进的致动传递机构或者组件,它们被构造成起到故障安全“保险”或装置的作用,当来自厚组织的击发负载超过预定量级时可防止致动轴46行进(例如防止致动动作传递到一次性装载单元)。
图90示出了一种致动传递组件100,其包括传动爪42’,该传动爪具有爪主体部分102,所述爪主体具有齿条接合元件或者齿43,其在总体标记为104的连接区与爪主体部分102连接或者在其上形成。在图90所示的实施方式中,底切或者变薄的区域45沿着至少一部分连接区104形成。底切或者变薄区域45的大小可被设置成当击发负载达到预定最大值时使齿43可从传动爪42’上折断或者采取不驱动位置,从而防止致动轴46的行进,即便可手动致动的手柄元件24继续被致动时也是如此。在各种实施方式中,可选择预定最大值,使齿43在任何其他元件由于驱动梁因阻塞或者其他限制而受到阻抗而出现故障或者变得不能操作之前被折断或者处于非驱动位置。
另一种爪设置在图91中示出。从该图中可以看出,爪42”具有宽度为“W”的爪主体106,并且接合齿43具有小于“W”的宽度“W’”,当击发负载超过预定量级时使接合齿43将折断或者出现故障,防止致动轴46进一步行进—即便可手动致动的手柄元件24继续被致动时也是如此。在各种实施方式中,爪42’、42”可由单个材料制成(模制、加工等)。在其他实施方式中,接合齿43独立于爪主体106形成并可通过剪切销(未显示)或者其他方式诸如粘合剂与其连接,将接合齿43支撑在位置中以便在正常负载下与致动轴46驱动接合,当击发负载超过预定量级时折断以允许齿43枢转到非接合位置。
图92示出了另一种致动传递组件100’,其包括被设计成当击发负载超过预定量级时失效的致动轴46’。在该实施方式中,底切区域108设置在相邻齿49之间,其尺寸设置成形成剪切区长度“SL”,当击发负载达到或者超过上面描述的预定量级时该区域有助于齿49的折断或者允许齿49从齿43上驱动脱离或者允许爪42上的齿43在齿条48’上的齿49上方滑动。在图93中示出的替代实施方式中,致动杆46”具有宽度“WB”并且每个齿49具有可小于宽度“WB”的宽度“WT”。宽度“WT”的尺寸可设置成当击发负载达到或超过如上所述的预定量级时使齿49能够从致动轴46”上折断或者出故障或者从爪42上的齿43驱动脱离。此外,传递组件的尺寸可设置成在合适负载下弯曲或者挠曲以便在预定负载下使齿从爪上脱离。在各种实施方式中爪和齿条上的齿可以非常宽的最小失效负载范围设计,这取决于所需的满意程度。所述最小失效负载可通过改变几何形状、设计和/或由其制成齿、粘合剂、剪切销等的材料来实现。
本领域普通技术人员将会理解,本发明的前述致动传递组件设置极大地改进了适于致动一次性装载单元的现有外科器械。特别是,当重新加载的单元受到可能导致切割和缝合元件的阻塞和/或故障以完全行进穿过被夹钳在单元中的组织的击发力时本发明的所述致动传递组件可防止临床医生使重新加载单元中的切割和缝合元件。在现有单元中,临床医生可能没有意识到被夹钳在单元中的组织的厚度太大而不能完成手术,并且通过致动手柄无意地继续在单元中行进切割和缝合器械,直到手柄组件破裂或者故障,丧失了回收刀的能力。如果元件变得阻塞,临床医生可能不能回缩元件,因此必从组织中断开单元。上面描述的本发明的各种设置解决了所述问题。
这些独特新颖的零件还可在使用驱动爪设置的其他外科切割和缝合器械中采用。例如,图93A和93B示出了两部分爪装置2000的使用,其可在申请号为11/821277的美国专利申请中公开的外科器械中有效地被采用,该专利由Chad P.Boudreaux和Jeffrey S.Swayze于2007年6月22日提交,题为“Surgical StaplingInstruments”,其公开内容通过引用而包含在本申请中。特别是,两部分爪组件2000可包括爪主体2010,其可如前述专利申请中所描述的那样被构造或操作,但在该实施方式中齿部分2020可枢转或运动连接到爪主体2010。齿部分2020可通过剪切销2030或者其他合适装置诸如粘合剂等沿驱动朝向正常支撑(图93A),在击发过程中当其击发构件2040遇到预定量的击发负载或者阻力时该装置被选择以剪切或者失效。图93A示出了与击发构件2040驱动接合的齿2020。图93B示出了击发构件2040已经遇到超过预定击发负载的阻力之后的位置,从而引起剪切销2030脱离,允许齿2020枢转到非接合位置。因此,当处于非接合位置时,击发构件2040不能向远侧行进,即便击发构件继续被致动也是如此。
图94-97示出了独特新颖的可进行关节运动的一次性装载单元3016,其可被用于外科缝合器械10或者上面在本文中描述的任何其他各种外科缝合器械。参见图96,一次性装载单元3016可包括具有砧座组件20和钉仓组件18的工具组件17。砧座组件20可包括砧座部分204,可具有多个在其下表面上形成的缝钉成形凹窝(未显示)。盖板208可与砧座部分204的顶面连接以在二者之间限定腔。腔的尺寸可设置成容纳轴向驱动组件212的远端。纵向槽214延伸穿过砧座部分204以利于轴向驱动组件212的固位凸缘284通过进入砧座腔。在砧座部分204上形成的凸轮表面209可被定位以接合轴向驱动组件212,以利于组织被夹钳在砧座组件20与钉仓18之间。在砧座部分204上形成的一对枢转构件211可被定位在承载器216中形成的槽213中以在打开和夹钳位置之间导引砧座部分204。
在各种实施方式中,钉仓组件18可包括限定了细长支撑通道218的承载器216,见图96。细长支撑通道218的尺寸可设置并构造成容纳钉仓220。沿着钉仓220和细长支撑通道218形成的相应片222和槽224可起到将钉仓220保持在支撑通道218中的作用。一对支撑柱223可在钉仓220上形成,使它们被定位成搁置在承载器216的侧壁上以便进一步将钉仓220稳定在支撑通道218中。
钉仓220可包括固位槽225以便容纳多个紧固件和推动器(如同已知的那样)。多个间隔设置的纵向槽230延伸穿过钉仓220以容纳致动滑车234的直立凸轮楔232。中央纵向槽282沿着钉仓220的长度以利于刀片280通过。在外科缝合器10的操作过程中,致动滑车234移动穿过钉仓220的纵向槽230,将凸轮楔232行进到与可操作地支撑在槽225中的推动器顺序接触,引起推动器(未显示)在槽225中垂直移动并将与推动器(未显示)相关的紧固件从槽225中促动到砧座组件20的缝钉变形腔中。
各种实施方式可包括安装组件202,其可包括上部和下部安装部分236和238。在一种实施方式中,上部安装部分236可设置有一对适于枢转容纳在承载器216的侧壁中的孔219中的耳轴237。一对抗弯曲弹簧241可被支撑在安装组件202中形成的相应腔中以提供对安装组件202内的分层刀组件的支撑。安装组件202的近侧部分可以非旋转地安装在远侧主体适配器243中,如图96所示。
一次性装载单元3016的外壳部分200可包括上半个外壳250和下半个外壳252。上半个外壳250的近端可包括接合凸节254以便可释放地接合细长主体14(图94)和插入末端193。凸节254形成与主体14远端的枪形连接,如美国专利NO.5865361中描述的那样。
从图96中还可以看出,轴向驱动组件212可包括细长驱动梁266,其包括远侧工作头268和近侧接合部分270。驱动梁266可由单片材料制成,或者优选由多个片层构成。接合部分270可包括一对接合指状件270a和270b,它们的尺寸可被设置并构造成可固定地接合在驱动构件272中形成的一对相应固位槽272a。驱动构件272可包括近侧孔口(未显示),其被构造成当一次性装载单元的近端与外科缝合器械10的细长主体14接合时容纳控制杆52的远端(见上面的描述)。
驱动梁266的远端可由支撑刀片280的垂直支撑柱278和在缝合手术其间接合致动滑车234的中央部分的抵接表面283限定。表面283基部的表面285可被构造成容纳沿着承载器216的底部滑动定位的支撑元件287。刀片280可被定位成略微在致动滑车234的后面平移经过钉仓220中的中央纵向槽2872以在缝合身体组织的缝钉排之间形成切口。当驱动梁266轴向行进时为了为外壳200内的驱动梁266提供支撑,刀片固定元件290可被安装在外壳200中。
固位凸缘284可从垂直支柱278向远端突出并可将一对圆柱形凸轮滚筒286支撑在其远端。凸轮滚筒286可包括冲压或焊接在销中并且其尺寸设置并构造成将凸轮表面209接合在砧座主体204上,以便砧座部分204夹钳在身体组织上。一对弹簧207可设置在砧座部分204的近端与上部安装部分236之间以将砧座组件20偏压到正常打开位置。
在图94-97中示出的重新加载单元3016采用“无源”关节运动设置。从那些附图中可以看出,重新加载单元3016包括通过例如近侧主体卡圈301与外壳组件200连接的柔性关节运动构件300。柔性关节运动构件300具有主体部分301,其可由例如聚乙烯、聚丙烯或者其他合适的材料制成,并包括多个由肋304分隔的切口302。在各种实施方式中,切口302和肋304可沿着柔性关节运动构件300以相等间隔设置,从而当柔性关节运动构件进行关节运动时形成连续的弯曲半径。具有多个弯曲半径的柔性关节运动构件300可通过在切口302与肋304之间不相等的间隔来实现。例如,所述设置可通过将肋304间隔设置在更接近一端而离另一端较远来实现。如同本领域普通技术人员能够理解的那样,增加切口302和/或肋304的间隔降低了具有增加间隔的部分的弯曲半径,更近地靠近枢轴点弯曲连接。相反,更靠近地间隔切口302和/或肋304导致更渐进的弯曲,具有更大的弯曲半径。作为替代,柔性关节运动构件300可由材料的组合制成,其外部可以是开缝的不锈钢,其与上面提到的塑料和聚合物材料相同的方式起作用。
在图94-97中示出的实施方式中,切口302包括至少部分围绕柔性关节运动构件300的周长延伸的环形槽。但是,切口302优选包括半圆形槽,其由穿过柔性关节运动构件300的纵向轴线L-L中央纵向脊柱306分隔开,使第一组肋在脊柱306的一个横侧上形成并且第二组肋在脊柱306的另一横侧上形成。该脊柱306帮助提供对柔性关节运动构件300的硬化并容纳穿过其中用于容纳外科工具诸如驱动组件212的槽310。纵向脊柱306可穿过柔性关节运动构件300的整个纵向长度。柔性关节运动构件300还可包括一对侧槽314,它们穿过每个横侧上的每个肋304以便容纳相应的关节运动板320。见图96。所述关节运动板320可由在弯曲后保持其位置的材料制成。关节运动板320可由例如诸如铅、铜、不锈钢等材料制成。
一次性装载单元3016的尺寸设置成以如图94和95所示的非关节运动状态经过套管针套管通路插入到患者(未显示)体内的外科部位以便进行外科手术。例如,一次性装载单元3016的尺寸设置成可经过胃镜或结肠镜插入。在一次性装载单元3016的工具组件17部分已经经过套管针套管通路插入之后,临床医生可通过“无源地”将工具组件17与器官或者身体的其他部分或者另一种医疗器械330(例如抓取器-图97)接触将工具组件17运动到所需关节运动朝向,以将外力施加到工具组件17,引起其在相对于一次性装载单元3016的外壳部分200的平面中进行关节运动。本领域普通技术人员将会理解,一旦工具组件17进行关节运动到所需位置,关节运动板320用于将工具组件17保持在该构型。工具组件17可进行关节运动经过角度“PA”,如图97所示。
图98-101示出了本发明的另一种重新加载单元3016’的实施方式。重新加载单元3016’大体上与重新加载单元16相同,但重新加载单元3016’被构造成无源地进行关节运动和有源地进行关节运动。从图98和99中可以看出,重新加载单元3016’包括第一关节运动接头340,其由包括远侧部分206和可与其枢转连接的近侧部分226的安装组件202’形成。在各种实施方式中,远侧部分206包括上部安装部分208和下部安装部分210。枢轴销244可在每个安装部分206’、208’上形成以限定枢转轴线“A1”,该轴大体上垂直于一次性重新加载单元3016’的纵向轴线“LL”。安装组件202’的近侧部分226可包括上部安装部分236’和下部安装部分238’。安装元件202’的远侧部分206和安装元件202’的近侧部分226可通过一对连接构件246可枢转地连接在一起。每个连接构件246具有穿过其中的孔247以便容纳穿过其中的相应销244。每个连接构件246的近端248被构造成连锁容纳在上部安装部分236’和下部安装部分238’中形成的相应槽251中。安装组件202’的近侧部分226可不旋转地安装在远端主体适配器243中,如图99所示。一次性装载单元3016’的外壳部分200可包括上半个外壳250和下半个外壳252。上半个外壳250的近端可包括用于接合细长主体14(在图99中未显示)和插入末端193的接合凸节254。凸节254形成与主体14的远端连接的卡扣型连接(将在下面进一步详细讨论)。上半个外壳250和下半个外壳252限定了用于将轴向驱动组件212滑动容纳在其中的通道253。一对弹簧207可设置在砧座部分204的近端与上部安装部分之间以将砧座组件20偏压到正常打开位置。
该实施方式还可采用柔性关节运动构件300’,其可大体上类似于上面描述的柔性关节运动构件300,其不同将在下面描述。柔性关节运动构件的远端可不旋转地固定到远端主体适配器243并且柔性关节运动构件300’的近端可不旋转地固定到与外壳部分200连接的近侧主体卡圈301。在该实施方式中,关节运动连接件256’可被采用,还使用户能够有源地使工具组件17进行关节运动。关节运动连接件256’可具有终止于远侧钩部分452中的细长柔性金属丝部分450。金属丝部分450可被容纳在柔性关节运动构件300’中的腔420中。带钩末端452可通过固定在二者之间的销销接在远侧部分206与下部安装部分210之间。见图99。柔性金属丝部分450可与杆部分451连接,所述杆部分具有片或者其他钩部分258’,该钩部分被构造成以公知的方式与在第一关节运动连接件123的远端上形成的远侧钩165钩接,如美国专利No.5865361中描述的那样。见图10。所述重新加载单元3016’设置可使用柔性关节运动构件300’围绕角“PA”以上面描述的方式通过行进“PA”的范围无源地进行关节运动,或者在需要时,临床医生可有源地使其工具组件17围绕第一关节运动轴“A1-A1”通过以美国专利No.5865361中描述方式致动关节运动杆30经过行进“AA”的范围进行有源关节运动,见图101。
图102-104示出了本发明的另一种重新加载单元3016”的实施方式。重新加载单元3016’大体上可与重新加载单元3016’相同,但重新加载单元3016”被构造成具有两个有源关节运动连接件256R、256L,使关节运动连接件300能够在一侧上被有源拉动同时在相对侧上被有源推动。从图103中可以看到,关节运动连接件256R和256L可具有远侧板部分430,其尺寸设置成延伸穿过关节运动构件300中的相应侧槽314。止推连接零件432可在每个远侧板部分430的远端上形成,将远侧板部分430保持在其各自的侧槽314中。在替代实施方式中,止推零件可在关节运动构件300中形成,或者其他连接装置可被使用。关节运动连接件256R、256L可进一步具有分别终止于钩部336R、336L中的细长延伸部分334R、334L。在各种实施方式中,关节运动连接件256R、256L可由金属或者一系列层压或堆叠的板制成。
参见图104,显示可大体上与上面描述的控制杆组件125类似的控制杆组件125’,但控制杆组件125’包括右关节运动连接件123R和左关节运动连接件123L。右关节运动连接件123R可具有在其上形成的远侧钩165R以便与一次性装载单元3016”中的关节运动连接件256R的钩部336R可拆卸地接合,见图103。同样地,左关节运动连接件123L可具有在其上形成的远侧钩165L以便与一次性装载单元3016”中的关节运动连接件256L的钩部336L可拆卸地接合。右关节运动连接件123R可进一步具有从其近侧突出的指状件164R,左关节运动连接件123L可具有从其近侧突出的指状件164L,尽管在图103中没有专门显示,但连接杆、齿轮传动链等也可被用于将指状件164R、164L与连接到移动构件138’的臂160可运动连接,当如上面详细描述的那样移动构件138’沿着远侧方向“DD”轴向行进时,使右关节运动连接件123R和256R沿着远侧方向“DD”行进,并且使右关节运动连接件123L和256L沿着近侧方向“PD”拉动,从而引起工具组件17围绕第一关节运动轴线“A1-A1”枢转到如图101中示出的纵向轴线L-L的右侧,反之亦然。同样地,在各种实施方式中,当移动构件138’沿着近侧方向“PD”行进时,右关节运动连接件123R和256R沿着近侧方向“PD”被拉动,并且右关节运动连接件123L和256L沿着远侧方向“DD”行进,从而引起工具组件17纵向轴线L-L的左侧,反之亦然。本领域普通技术人员将会理解,所述“推动”和“拉动”动作导致比仅仅采用单个关节运动连接件的那些现有关节运动装置施加到单个关节运动连接件上的应力更小。当与枢轴销装置例如在远侧部分206中相对时柔性关节运动构件300’可要求更大的力来弯曲或挠曲。
图105-107示出了本发明的另一种重新加载单元3016”’实施方式。重新加载单元3016”’基本上时重新加载单元3016和3016’的组合,其中重新加载单元3016”’采用了关节运动连接件256’和关节运动连接件256R和256L,使关节运动连接件300’能够在行程“PA”的范围内进行无源地关节运动并在另外的行程“AA”范围内进行有源关节运动。
图108-111示出了被构造成用于一次性装载单元的本发明的另一种外科缝合器械4010。图108示出了一次性装载单元16,其具有上面描述的类型和构造的第一关节运动结构340,使工具组件17能够相对于与外科缝合器械4010连接的一次性装载单元外壳200围绕第一枢转轴线A1-A1枢转。外科缝合器械4010可具有大体上类似于上面描述的各种缝合器械实施方式的方面和元件的方面和元件,但具有独特新颖的关节运动系统4012,其各种构造将在下面详细描述。与在上面提到的外科缝合器械实施方式中采用的元件相同的那些元件将用同样的附图标记来标记,本领域普通技术人员可参考上面阐明的解释它们的构造和操作的公开内容。从图108中可以看出,关节运动系统4012可包括中间关节运动接头4020,其被安放在一次性装载单元16与手柄组件12之间的细长主体组件4014中,使一次性装载单元16可围绕第二关节运动轴线A2-A2相对于手柄组件18选择性地枢转。如图108所示,第二关节运动轴线A2-A2大体上与纵向轴线L-L和第一关节运动轴A1-A1垂直。
从图108和109中可以看出,细长主体组件4014可包括远侧主体部分4030和近侧主体部分4040,它们在中间关节运动接头4020处连接在一起。关节运动系统4012可进一步包括移动构件138,其具有直立的臂部分540,该臂部分中具有尺寸设置成容纳在传感器筒178上形成的片544的切口542。移动构件138的远端可包括臂546,该臂546包括被构造成容纳从关节运动连接件4050的近端延伸的指164的开口548。可由非磨损材料例如或涂敷了的金属构建的销166与移动构件138连接并且其尺寸设置成被容纳在阶梯式凸轮表面148中(在图11中显示)。那些元件的操作见上面的描述。
图110示出了本发明的中间关节运动接头实施方式4020。从该图中可以看出,远侧主体部分4030为中空的并具有近端4031,该近端具有两个在其上形成的向近侧突出的凸节4032。每个凸节4032可具有从其上突出的销4034和至少一个在其上形成的锁定肋4036。近侧主体部分4040是中空的,从图109中可以看出,其具有近端4041,该近端具有用于容纳在可旋转把手28上形成的相应径向突起(在图10中显示)的开口128(如上面描述的那样)。从图110中可以看出,近侧主体部分4030的远端4042可具有一对向远侧突出的凸节4044,每个凸节都具有穿过其中的销容纳孔4046以便容纳远侧主体部分4030上的相应销4034,使远侧主体部分4030能够相对于近侧主体部分4040枢转。每个凸节4044可具有在其上形成的一系列径向槽4048以与凸节4032上的锁定肋4036相向接合。因此,当组装在一起时,销4034和孔4046用于限定第二关节运动轴线A2-A2并且松散配合,通过将力施加到远侧主体部分4030上同时保持近侧主体部分4040固定使远侧主体部分4030能够相对于近侧主体部分4040枢转到所需位置,反之亦然。锁定肋4036与槽4048之间的相互作用用于在关节运动力已经中断之后将远侧主体部分4030相对于近侧主体部分4040保持在所需位置。在替代实施方式中,锁定肋4036可在向远侧突出的凸节4044上形成并且径向槽4048可在向近侧突出的凸节4032上形成。在还一种实施方式中,至少一个锁定肋4036可在凸节4032上形成并且径向槽4048可设置在与其连接的凸节4044上,并且至少一个锁定肋4036可设置在另一个凸节4044上并且槽4048设置在与该凸节4044连接的凸节4032上。当通过中间关节运动接头4020连接在一起时,细长主体组件4014的远端主体部分4030和近侧主体部分4040限定了纵向轴线L-L。
如上所述,关节运动系统4012可进一步包括关节运动连接件4050,该关节运动连接件包括具有从其上突出的凸缘164并被构造成被容纳在移动构件138的臂546中的开口548中的近侧部分4052,见图109。关节运动连接件4050可进一步具有远侧部分4054,其可枢转销接到近侧部分4052上,使远侧部分4054可围绕关节运动轴线A2’-A2’相对于近侧部分4052枢转。远侧部分4054的远端具有在其上形成的远侧钩165,用于以公知的方式可拆卸地接合一次性装载单元16中的关节运动连接件的钩部。从图109中还可以看出,该实施方式可采用中空传感器管4060,其具有与近侧部分4064枢转连接的远侧部分4062以便围绕关节运动轴线A2”-A2”相对于其枢转行进。传感器管4060的远侧部分4062和近侧部分4064可松散地连接在一起,使传感器管4060能够容纳元件的一些轴向对准偏差。例如,在各种实施方式中,传感器管的远侧部分4062和近侧部分4064可被连接以允许那些元件彼此之间的±0.125英寸的轴向运动。传感器管4060可以与上面参照传感器管123描述的相同方式操作并可具有与其连接的上面描述的类型的控制杆锁定机构(未显示)。
从图109中还可以看出,关节运动系统4012可包括控制杆组件4070,其在操作方面类似于上面的控制杆52,但具有与远侧部分4072和近侧部分4076交联的关节运动部分4074。关节运动部分4074可包括一系列层压金属带,当细长主体组件4014围绕中间关节运动接头4042进行关节运动时它们可使控制杆组件4070能够弯曲,并且还足够硬以便将来自手柄组件12轴向传递到一次性装载单元16。其他柔性接头装置也可被采用。另外,O形环4080可设置在控制杆组件4070的近侧部分4076与传感器管4060之间以提供对其中的控制杆组件4070的另外支撑。当装配在一起时,本领域普通技术人员将会理解关节运动连接件4050和传感器管4060被支撑在细长主体组件4014中,使轴线A2”-A2”和A2’-A2’大体上与第二关节运动轴线A2-A2一致。同样地,控制杆组件4070被支撑在细长主体组件4014中,使关节运动部分4074跨过中间关节运动接头4020。
图111示出了外科缝合器械4010在“开方式”外科手术装置中的应用,其中一次性装载单元16和细长主体组件4014经过组织“T”中的开放切口被插入到患者体内。如同参照该图所理解的那样,工具组件17可通过操作关节运动杆30(见上面的描述)围绕第一关节运动轴线A1-A1选择性地进行关节运动。通过“无源地”将工具组件17与器官或者其他身体部分接触或者使用另一种外科器械例如诸如抓取器(未显示)握持一次性装载单元16以引起其围绕第二关节运动轴线A2-A2运动,一次性装载单元16还可相对于细长主体组件4014的近侧主体部分4040和手柄组件12围绕第二关节运动轴线A2-A2运动。本领域普通技术人员将会理解,一旦工具组件17围绕第二关节运动轴线A2-A2进行关节运动到所需位置,其就借助于接合在锁定肋4036与径向槽4048之间而被保持在该位置(见上面的描述)。为了使缝合器械4010能够通过常规套管针4000被内窥镜使用(如图112所示),中间关节运动接头4020可保持在套管针4000之外,使手柄组件12能够围绕第二关节运动轴线A2-A2相对于经套管针4000突入到患者体内的外科缝合器械4010部分枢转。
图113-115示出了可在本发明的各种外科缝合器械中采用的关节运动系统5012。与在上面提到的外科缝合器械实施方式中采用的元件相同的那些元件将用同样的附图标记来标记,本领域普通技术人员可参考上面阐明的解释它们的构造和操作的公开内容。关节运动系统5012可包括在细长主体组件5014中的中间关节运动接头5020,有利于一次性装载单元16围绕纵向轴线L-L和第一关节运动轴线A1-A1相对于手柄组件12枢转行进。细长主体组件5014可包括远侧主体部分5030和近侧主体部分5040,它们在中间关节运动接头5020处连接在一起,如图114中所示,关节运动系统5012可进一步包括移动构件138,其具有直立的臂部分540,该臂部分中具有尺寸设置成容纳在传感器筒178上形成的片544的切口542。移动构件138的远端可包括臂546,该臂546包括被构造成容纳从关节运动连接件4050的近端延伸的指状件164的开口548。可由非磨损材料例如或涂敷了的金属构建的销166与移动构件138连接并且其尺寸设置成被容纳在阶梯式凸轮表面148中(在图11中显示)。那些元件的操作见上面的描述。
如同图114中进一步显示的那样,远侧主体部分5030为中空的并具有近端5031,该近端具有两个在其上形成的向近侧突出的凸节5032。近侧主体部分5040为中空的,并具有用于容纳在可旋转把手28上形成的相应径向突起的开口128(如上面描述的那样),见图114和115。近侧主体部分5040的远端5042可具有一对向远侧突出的凸节5044,每个凸节都具有穿过其中的销容纳孔(未显示)以便容纳远侧主体部分5030上的相应销5034,使远端主体部分5030能够相对于近侧主体部分5040枢转。在各种实施方式中,中间关节运动接头5020可形成有径向槽4048和锁定肋4036(见上面的描述)。在其他实施方式中中间关节运动接头4020可不具有所述径向槽和锁定肋。
图113-115中示出的关节运动系统5102是“有源”关节运动系统并具有关节运动杆5050,所述关节运动杆具有通过销5054销接或者连接到远侧主体部分5030的远端5052。如图114中所示,关节运动杆5050可骑设在设置在细长主体组件5014的近侧主体部分5040中的细长杆槽5043中。为了提供对关节运动杆5050的另外支撑,护罩5080可设置在近侧主体部分5040上方,见图113和115。关节运动杆5050可具有近端5056,其与固定卡圈5060一体形成或者与其不可运动地连接。固定卡圈5060的尺寸可设置成围绕近侧主体部分5040配合并具有与其连接的基部5062,所述基部与终止于关节运动钮5066中的钮柱5064连接或者与其一起形成。从图114和115中可以看出,基部5062可形成有两个向上延伸的锁定定位凹槽5068,它们适于止动接合锁定齿条5072,锁定齿条5072形成在两个锁定板5070上,锁定板5070不旋转地支撑在可旋转把手28中。如图114和115所示,可采用两个锁定板5070——钮柱5064的每侧上一个。
参见图113,为了使远侧主体部分5030和控制杆组件4070(以及与其连接的一次性装载单元)的远侧部分4072围绕第二关节运动轴线A2-A2沿着向右的方向“RD”进行关节运动,临床医生简单地沿着远侧方向“DD”滑动关节运动钮5066。为了使远侧主体部分5030和控制杆组件4070的远侧部分4072以及一次性装载单元沿着向左的方向“LD”进行关节运动,临床医生简单地沿着近侧方向“PD”滑动关节运动钮5066。本领域普通技术人员将会理解,关节运动系统5020可有效地被用于适于容纳可进行关节运动和不可进行关节运动的一次性装载单元的外科缝合器械。图113-115中示出的关节运动系统5012很好地适用于开放式外科应用。图116中示出的关节运动系统5012’可更好地适用于内窥镜应用。从该图中可以看出,关节运动接头5020更靠近可旋转把手28,当应用时,使关节运动接头5020置于细长主体组件5014的远侧主体部分5030可经过其延伸的套管针之外。
图117-121示出了独特新颖的可与适用于一次性装载单元的各种外科缝合器械结合使用的“有源”关节运动系统6012。关节运动系统6012的与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来标记,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。在各种实施方式中,关节运动系统6012包括可旋转把手组件6028,除了下面提到的不同之外,其类似于在上面描述的可旋转把手28。从图118中可以看出,可旋转把手6028具有关节运动护罩延伸件6030,该延伸件具有在其上形成的远侧关节运动球6032。在各种实施方式中,可旋转把手组件6028可由两部分6028a和6028b形成,它们可由塑料或者其他合适的材料制成,并可通过例如卡扣件、螺钉、粘合剂等相互连接,见图117。远侧主体部分6040可旋转地接收在远侧关节运动球6032中,该主体部分的近端6042形成关节运动凹窝6044,其可由可通过卡扣件、粘合剂等相互连接在一起的盖部分6040a和6040b形成,如图118中所示,关节运动系统6012还可包括上面描述的被构造成容纳从关节运动连接件4050’的近端延伸的指状件164的移动构件的类型和构造的移动构件。关节运动连接件4050’类似于上面描述的关节运动连接件4050,但关节运动连接件4050’具有在其中形成的柔性连接器部分(螺旋弹簧等)6025。
如图118中可以看出的那样,关节运动系统6012可进一步包括中空传感器管6060,其具有通过柔性连接器(螺旋弹簧等)6066与近侧部分6064连接的远侧部分6062。传感器管6060可以上面参照传感器管123描述的相同方式操作,并可具有与其相连的上面描述的类型的控制杆锁定机构(未显示)。如同从图118中还可以看出的那样,关节运动系统6012可包括控制杆组件6070,其类似于上面的控制杆52,但具有将远侧部分6072与近侧部分6076相互连接的柔性连接器部分6074。柔性连接器部分6074可包括螺旋弹簧等,其可使控制杆组件6070在关节运动过程中弯曲,然而又足够硬到能够将来自手柄组件12的击发力传递到一次性装载单元16。从图118和119中可以看出,控制杆组件6070延伸穿过传感器管6060并且近侧部分6076由O形环6068支撑于其中。为了提供对关节运动杆6070近侧部分6076和柔性连接器部分6074的另外支撑,近侧击发杆管6080可被采用,见图118和119。当组装在一起时,本领域普通技术人员将会理解,关节运动连接件4050’的挠性连接器部分6025、传感器管6060的柔性连接器部分6066和柔性连接器部分6074被支撑在关节运动球6032中,如图119所示。
从图118和119中可以看出,关节运动系统6012进一步包括可运动支撑在护罩延伸件6030的远端6034上的关节运动手柄6090。在各种实施方式中,关节运动手柄6090可由两个弧形部分6090a和6090b形成,它们通过例如螺钉6091或者其他合适的紧固件装置连接在一起。关节运动手柄6090与两个在直径上相对的水平关节运动带6100和两个在直径上相对的垂直关节运动带6110连接。见图118。现在参见图120和121,在各种实施方式中,每个水平关节运动带6100的近端6012可枢转连接到水平关节运动销6014。同样地,每个垂直关节运动带6100的近端6112可枢转连接到垂直关节运动销6114。图120和121示出了将水平关节运动带6112的近端6102与水平关节运动销6104连接以及将垂直关节运动带6110的近端6112与垂直关节运动销6114连接的一种形式。从那些图中可以看出,球形连接器6120可与远端6102、6112连接并可分别可旋转地容纳在水平和垂直关节运动销6104、6114中的相应凹窝6108、6118中。水平关节运动销6104可延伸穿过被容纳在关节运动手柄6090中的孔6092中的护罩延伸件6030的近侧部分6034中形成的在直径上相对的水平槽6036(图118)。类似地,垂直关节运动销6114延伸穿过在被容纳在关节运动手柄6090中的孔6094中的护罩延伸件6030的近侧部分6034中形成的在直径上相对的水平槽6038。
在各种实施方式中,水平关节运动带6100和垂直关节运动带6110可包括金属带,它们可围绕它们的弱轴(即横向于它们的长度的轴)弯曲或挠曲,但不沿着它们的强轴(即沿着它们的长度延伸的细长轴)弯曲或挠曲。为了沿着它们各自的长度为关节运动带6100、6110提供支撑,水平关节运动带6100可运动地支撑在细长护罩6030中形成的细长水平槽6033中。每个水平关节运动带6100的远端6106都可具有从其上突出的远端关节运动销6109,该远端关节运动销延伸穿过将与远侧主体部分6040连接的细长护罩6030的球形部分6032中的相应水平槽6037。在各种实施方式中,远侧关节运动销6109延伸穿过水平关节运动带6100的相应远端6106中的孔以便使其远端6106能够在其周围旋转。类似地,每个垂直关节运动带6110的远端6116可具有从其上突出的远侧关节运动销6119,该远侧关节运动销延伸穿过将与远侧主体部分6040连接的细长护罩6030的球形部分6032中的相应垂直槽6039,见图119。远侧关节运动销6119可延伸穿过延伸穿过相应垂直关节运动带6110的远端6116中的孔以便使其远端6116能够在其周围旋转。
虽然在图117-118中没有特别显示,本领域普通技术人员将会理解,远侧主体部分6040可被构造成以上面描述的方式或者本领域公知的方式可操作地连接到进行关节运动的一次性装载单元或者不进行关节运动的一次性装载单元。但是,在该实施方式中,临床医生可通过选择性地枢转护罩延伸件6030的近端6034上的关节运动手柄6090,选择性地使远侧主体部分6040以及与其连接的一次性装载单元进行关节运动。例如,图119示出了被枢转到其中远侧主体部分6040沿着垂直方向“VD”被枢转的位置中的关节运动手柄6090。为了沿着水平方向(垂直于图119中示出的方向VD的方向)枢转远侧主体部分6040,临床医生首相将关节运动手柄返回到垂直的中间位置(其中远侧主体部分6040与护罩延伸件6030共轴),然后临床医生枢转关节运动手柄,使手柄6090的一侧部分沿着远侧方向运动,同时另一侧沿着近侧方向运动(由图117中的箭头“DD”和“PD”表示)。所述有源关节运动包括大体上为双平面的关节运动。也就是说,远侧主体部分6040以及与其连接的一次性装载单元仅仅能够经过垂直延伸的平面或者经过大体上与垂直延伸的平面正交的水平延伸的平面选择性地进行关节运动。远侧主体部分6040和一次性装载单元不能同时在垂直和水平平面中进行关节运动。但是,本领域普通技术人员能够理解,可旋转把手6028借助于其与手柄组件的旋转连接便于使远端主体部分6040以及与其连接的一次性装载单元围绕纵向轴线L-L选择性旋转。
图122和123示出了采用无源关节运动系统7012的本发明的另一种外科缝合器械7010的实施方式。从那些图中可以看出,无源关节运动系统7012可包括可旋转把手7028,其略微类似于上面描述的可旋转把手28,下面将讨论其不同。外科缝合器械7010的与上面提到的实施方式中采用的元件相同的那些元件将使用相同的附图标记来标记,本领域普通技术人员可参照在上面阐明解释它们的构造和操作的公开内容。从图123中可以看出,可旋转把手7028具有在其中形成的关节运动凹窝7030,其尺寸设置成可旋转地容纳在细长主体组件7014中形成的球7016。在替代实施方式中,凹窝7030可在不旋转地支撑在可旋转把手7028中的壳体部分上形成。细长主体组件7014的远端7015被构造成以本领域公知的方式可操作地连接到可进行关节运动或者不可进行关节运动的一次性装载单元。从图123中还可以看出,关节运动系统7012可进一步包括移动构件138.其具有直立臂部分540,该臂部分中带有切口542,切口的尺寸设置成以本领域公知的方式在传感器筒(未显示)上形成的片(未显示)。移动构件138的远端可包括臂546,该臂包括被构造成容纳从关节运动连接件7050上延伸的指状件164的开口548。关节运动连接件7050的远端7054具有在其上形成的远侧钩165,其可钩接在支撑在一次性重新加载单元中的关节运动连接件上形成的关节运动片或钩。可由非磨损材料例如或涂敷了的金属构建的销166与移动构件138连接并且其尺寸设置成被容纳在阶梯式凸轮表面148中(在图11中显示)。从图123中可以看出,螺旋弹簧或者类似形式的柔性构件7055可设置在与其近端7052相邻的关节运动连接件7050中。
无源关节运动系统7012可进一步包括中空传感器管7060,其具有通过柔性连接器(螺旋弹簧等)7066与近侧部分7064连接的远侧部分7062。传感器管7060可以上面参照传感器管123描述的相同方式操作,并可具有与其相连的上面描述的类型的控制杆锁定机构(未显示)。如同从图123中还可以看出的那样,关节运动系统7012可包括控制杆组件7070,其类似于上面的控制杆52,但具有将远侧部分7072与近侧部分7076相互连接的柔性连接器部分7074。柔性连接器部分7074可包括螺旋弹簧等,其可使控制杆组件7070在关节运动过程中弯曲,然而又足够硬到能够将来自手柄组件12的击发力传递到一次性重新加载单元16。击发杆组件7070延伸穿过传感器管7060并且近侧部分7076由O形环7068支撑于其中。当组装在一起时,本领域普通技术人员将会理解,关节运动连接件7050的挠性连接器部分7075、传感器管7060的柔性连接器部分7066和控制杆组件7070的柔性连接器部分7074至少部分被支撑在关节运动球7016和凹窝7030中。
图122示出了本发明的外科缝合器械7010用于常规套管针4000。如同从该图中看出的那样,一次性装载单元16与细长主体组件7014连接。虽然示出了可进行关节运动的一次性装载单元16,但本领域普通技术人员将会理解,器械7012可在不可进行关节运动的一次性装载单元中有效地被使用,在套管针4000利用已知技术已经经过组织“T”安装之后,临床医生可经过套管针将一次性装载单元16插入到患者体内。如果采用可进行关节运动的一次性装载单元16,则临床医生必须以不进行关节运动的状态定向一次性装载单元以便将其经过套管针插入。在一次性装载单元16已经插入到患者体内并以上面描述的方式致动以夹钳在目标组织上之后,临床医生可简单地通过围绕球窝关节运动接头7020枢转手柄组件12使手柄组件进行关节运动。球部7016的尺寸设置成与凹窝7030相关,在静止时使元件之间建立足够量的摩擦力以保持它们的位置,然而该摩擦力又没有大到防止那些元件彼此之间的操作。在其他实施方式中,可在球窝接头元件中设置定位凹槽以将接头保持在各种位置中。临床医生还可在夹钳到目标组织12上之前通过握持从套管针4000突出的细长手柄组件的近端然后操纵与其相关的手柄组件12,相对于细长主体组件7014操纵手柄组件12。
虽然已经描述了本发明的一些实施方式,但可以想到的是,本领域技术人员为获得本发明的一些或者所有优点,可对这些实施方式进行各种修改、变化和改变。例如,根据各种实施方式,单个元件可被多个元件代替,多个元件也可被单个元件代替,来执行给定的一种或多种功能。本申请因此覆盖了所有这些修改、改变和变化,都不偏离由所附的权利要求书所限定的本发明的精神和范围。
在本文中公开的装置可被设计成在单次使用后可抛弃的,或者它们可被设计成可重复使用的。但在任何一种情况下,在至少一次使用后装置可再生以便重新使用。再生可包括下列步骤的任何组合:装置拆卸,然后清洁并替换特定部件,随后重新组装。特别是,装置可被拆卸,任意数目的特定部件或者装置的部分可选择性地以任意组合被替换或者除去。当清洁和/或替换特定部分时,装置可在再生工厂或者由外科团队在外科手术前立即重新组装以便后续使用。本领域普通技术人员将会理解,装置的再生可利用用于拆卸、清洁/替换和重新装配的各种不同技术。所述技术的使用以及产生的再生装置都属于本申请的范围。
优选地,在这里所描述的本发明在外科手术前处理。首先得到新的或者使用过的器械,如果可能的话,对其进行清洁。器械然后可被消毒。在一种消毒技术中,器械被放置在密闭并密封的容器中,诸如塑料或者袋。容器和器械然后放置在可穿透容器的辐射场所中,诸如γ射线、x-射线或者高能电子。辐射杀死器械上和容器中的细菌。消毒的器械然后可存放在消毒容器中。密封容器保持器械无菌,直到其在医疗场合被打开。
声称通过引用而包含在本申请中的任何专利、出版物或者其他形式的公开材料,全部或部分,在本文中仅仅包含到所包含的材料不与在本申请中阐明的现有定义、陈述或者其他公开材料相矛盾的程度。这样,并且在需要的程度,在本文中明确阐明的公开内容代替了任何通过引用而包含在本申请中的相矛盾的材料。声称通过引用而包含在本申请中但与现有定义、陈述或者其他公开材料相矛盾的任何材料或者其部分仅仅包含到不引起所包含的材料与现有公开材料不相矛盾的程度。
试图保护的本发明不被解释为由所公开的特定实施方式所限定或限制的内容。因此这些实施方式被认为是示意性的而不是限制性的。可在不偏离本发明的精神和范围的情况下对其进行变化和改变。因此,清楚的是落入由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物、变化和改变由此而被包括。
Claims (10)
1、一种被构造成与能够进行外科手术的端部执行器一起使用的外科器械,所述外科器械包括:
细长主体,其可操作地与所述端部执行器连接以便将致动动作传到所述端部执行器上;
可手动致动手柄,其用于产生所述致动动作;
致动轴,其可操作地与所述细长主体和所述可手动致动手柄连接,以便将通过所述可手动致动手柄产生的所述致动动作传递到所述细长主体;和
传动爪,其与所述可手动致动手柄连接,所述传动爪具有爪主体,该爪主体上具有传动齿,该传动齿被构造成与所述致动轴相互作用,使得当所述可手动致动手柄被致动时,所述传动齿与所述致动轴相互作用,引起所述致动轴将所述致动动作施加到所述细长主体上,并且当与所述细长主体连接的所述端部执行器受到超过预定量的击发负载的击发负载时,所述传动齿相对于所述爪主体运动以与所述致动轴脱离,从而即使在所述可手动致动手柄继续被致动时也能防止所述致动动作进一步传递到所述细长主体。
2、如权利要求1所述的外科器械,其中,当所述击发负载超过所述预定量时所述传动齿从所述爪主体上脱离。
3、如权利要求2所述的外科器械,其中,所述传动齿在连接区与所述爪主体连接。
4、如权利要求3所述的外科器械,还包括位于所述爪主体中并邻近所述连接区的底切区域。
5、如权利要求1所述的外科器械,其中,所述爪主体具有爪宽度,其中所述传动齿具有小于所述爪宽度的齿宽度。
6、如权利要求3所述的外科器械,其中,所述传动齿通过粘合剂与所述连接区连接。
7、如权利要求1所述的外科器械,其中,所述致动轴上具有能够与所述传动齿驱动接合的齿条。
8、如权利要求7所述的外科器械,其中,当所述击发负载超过所述预定量时,构成所述齿条的至少一部分齿被构造成能够运动地脱离所述传动齿。
9、如权利要求1所述的外科器械,其中,所述传动齿能够运动地连接到所述爪主体,并通过剪切式构件保持在驱动位置中,当所述端部执行器受到超过预定量的击发负载时,该剪切式构件允许所述传动齿相对于所述爪主体运动。
10、一种处理用于外科手术的器械的方法,所述方法包括:
获得如权利要求1所述的外科器械;
对所述外科器械进行消毒;
将所述外科器械存储在无菌容器中。
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US12/031,368 | 2008-02-14 | ||
US12/031,368 US8584919B2 (en) | 2008-02-14 | 2008-02-14 | Surgical stapling apparatus with load-sensitive firing mechanism |
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EP (1) | EP2090246B1 (zh) |
JP (1) | JP5478907B2 (zh) |
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- 2009-02-13 RU RU2009105141/14A patent/RU2499567C2/ru active
- 2009-02-13 EP EP09250382.0A patent/EP2090246B1/en active Active
- 2009-02-16 CN CN2009100078378A patent/CN101507631B/zh not_active Expired - Fee Related
- 2009-02-16 BR BRPI0901656A patent/BRPI0901656B8/pt not_active IP Right Cessation
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Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102525586A (zh) * | 2012-02-09 | 2012-07-04 | 上海逸思医疗科技有限公司 | 外科器械的控制装置 |
CN102525586B (zh) * | 2012-02-09 | 2016-02-24 | 上海逸思医疗科技有限公司 | 外科器械的控制装置 |
CN104602618A (zh) * | 2012-06-28 | 2015-05-06 | 伊西康内外科公司 | 用于将外科器械的第一部分联接到外科器械的第二部分的旋转支撑接头组件 |
CN111803164A (zh) * | 2020-08-27 | 2020-10-23 | 武汉智瓴医疗科技有限公司 | 用于击发吻合器的电动推击装置及电动吻合器 |
CN111803164B (zh) * | 2020-08-27 | 2023-11-10 | 武汉智瓴医疗科技有限公司 | 用于击发吻合器的电动推击装置及电动吻合器 |
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US20120286019A1 (en) | 2012-11-15 |
BRPI0901656A2 (pt) | 2010-11-16 |
US20130126583A1 (en) | 2013-05-23 |
EP2090246B1 (en) | 2020-04-22 |
EP2090246A2 (en) | 2009-08-19 |
US8584919B2 (en) | 2013-11-19 |
JP2009189822A (ja) | 2009-08-27 |
EP2090246A3 (en) | 2012-12-05 |
CN101507631B (zh) | 2012-11-28 |
BRPI0901656B8 (pt) | 2021-06-22 |
US8657178B2 (en) | 2014-02-25 |
BRPI0901656B1 (pt) | 2020-02-18 |
RU2009105141A (ru) | 2010-08-20 |
RU2499567C2 (ru) | 2013-11-27 |
JP5478907B2 (ja) | 2014-04-23 |
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