CN102711630B - 在无菌环境中使用的部件 - Google Patents
在无菌环境中使用的部件 Download PDFInfo
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- CN102711630B CN102711630B CN201080061835.8A CN201080061835A CN102711630B CN 102711630 B CN102711630 B CN 102711630B CN 201080061835 A CN201080061835 A CN 201080061835A CN 102711630 B CN102711630 B CN 102711630B
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- surgical instruments
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Abstract
本发明涉及外科器械,该外科器械包括被膜包封的第一部分以及具有外科器械主体和外科器械主体内的腔体的第二部分。腔体能够接纳第一部分。第二部分包括:第一区域,该第一区域包括与腔体连通的开口,和闭合构件,该闭合构件能够在第一位置和第二位置之间运动。当闭合构件处于第一位置时,该闭合构件与第二区域可密封地接合,当闭合构件处于第二位置时,该闭合构件至少部分地不与第二区域可密封地接合。第一部分或第二部分上的一个或多个电气触头能够在闭合构件从第二位置运动到第一位置时刺穿膜,以允许在第一部分和第二部分之间进行连接。
Description
优先权
本发明是部分继续申请,根据35U.S.C.§120要求2009年2月5日提交的名称为“STERILIZABLE SURGICAL INSTRUMENT(可消毒外科器械)”、序列号为12/366,548的共同未决的美国专利申请的优先权,其整个公开以引证的方式并入本申请。
技术领域
本发明整体上涉及适合在无菌环境中使用的外科器械,更具体地,本发明涉及具有第一部分和第二部分的外科器械,其中在一个实施例中,第一部分通过膜进行包封,使得其能够与第二部分接合并且用在无菌环境中。本发明还涉及适用于无菌环境中使用的电子元件。
背景技术
外科器械制成后和/或外科器械已在外科手术中使用后,该外科器械可被物理消毒和/或化学消毒,以杀灭或消除其上的传染因子。物理消毒可包括在很多情况下可能合适的伽马射线消毒。然而,在某些情况下,伽马射线可能会损害例如外科器械的电子元件和/或电源。因此,可用于消毒这类外科器械的选择方案可能限于热或蒸汽消毒和/或化学消毒,如使用环氧乙烷、臭氧和/或过氧化氢。虽然这类选择方案在许多情况下适用,但是例如与伽马射线消毒相比,它们可能比较昂贵和/或耗时。在其它例子中,电子元件和/或电源可不进行消毒到它们可在外科手术期间敞开地暴露在手术室中的水平。需要对上述情况加以改善。
上述讨论仅仅为了举例说明本发明技术领域内目前存在的一些不足,而不应看作是对权利要求范围的否定。
发明内容
在本发明的一个总体方面中,外科器械可包括第一部分、包封第一部分的膜和第二部分,该第一部分为例如电源,例如包括至少一个第一电气触头。第二部分可包括外科器械主体和在该外科器械主体中限定一腔体的壁。该腔体可能够至少部分地接纳第一部分,同时第一部分保持被膜包封。第二部分还可包括:第一区域,该第一区域包括至少一个第二电气触头;第二区域,该第二区域包括与腔体连通的开口;和闭合构件,该闭合构件能够在第一位置和第二位置之间运动。当闭合构件处于第一位置时,该闭合构件可与第二区域可密封地接合;当闭合构件处于第二位置时,该闭合构件可至少部分地不与第二区域可密封地接合。第一电气触头和/或第二电气触头可被构造为刺穿膜,以允许至少当闭合构件从第二位置移入第一位置时在第一部分和第二部分之间进行电气连接。
在本发明的另一个总体方面中,外科器械系统可包括第一部分和密封包装,该第一部分包括至少一个第一电气端子。第一部分可位于密封包装内,并且密封包装可包括微生物不可渗透的阻挡层。外科器械系统还可包括第二部分,该第二部分包括外科器械主体和在外科器械主体中限定的接纳狭槽。接纳狭槽可被构造为当第一部分位于密封包装中时接纳第一部分的至少一部分。第二部分还可包括:第一区域,该第一区域包括至少一个第二电气端子;第二区域,该第二区域限定一进入接纳狭槽的通道;和闭合构件,该闭合构件能够在第一位置和第二位置之间运动。当闭合构件处于第一位置时,该闭合构件可与第二区域可密封地接触;当闭合构件处于第二位置时,该闭合构件可至少部分地不与第二区域可密封地接触。闭合构件可包括凸轮表面,该凸轮表面能够迫使第一部分进入接纳狭槽,并且能够使得第一电气端子和第二电气端子中的一个刺穿密封包装,以允许至少当闭合构件从第二位置移入第一位置时在第一部分和第二部分之间进行电气连接。
在本发明的另一个总体方面中,电子元件组件可被构造为放置成与外科器械电气连通。电子元件组件可包括电子元件,该电子元件能够当电子元件组件放置成与外科器械电气连通时向外科器械供电和/或控制外科器械。壳体可围绕电子元件。壳体可包括:外表面,该外表面包括能够至少抵抗微生物污染的材料;至少一个通风口,其限定在壳体中;和气体可渗透、微生物不可渗透的阻挡物,该阻挡物设置在至少一个通风口上方并且能够至少抑制微生物从壳体排出。
在本发明的另一个总体方面中,外科器械模块可包括电子元件,该电子元件能够在外科器械模块处于与外科器械电气连通时向外科器械供电和控制外科器械中的至少一种。壳体可包封电子元件。壳体可包括:外表面,该外表面包括第一抗微生物材料;至少一个通风口,其形成在壳体中;和气体可渗透、微生物不可渗透的阻挡物,该阻挡物设置于至少一个通风口上方。气体可渗透、微生物不可渗透的阻挡物可被构造为防止电子元件上的微生物离开壳体,同时允许气体流入和流出壳体。外科器械模块还可包括翅片,该翅片连接到壳体并且从电子元件延伸开。翅片可被构造为消散由电子元件产生的热并且可包括第二抗微生物材料。
本发明内容旨在简要概述本发明的某些实施例。应当理解,本发明不限于本发明内容中所公开的实施例,而是有意涵盖其权利要求所规定的精神和范围内的修改形式。还应当理解,本发明内容不应被解读或理解为将用来限制权利要求书的范围。
附图说明
通过结合附图参考本发明实施例的以下说明,本发明的上述和其它特征及优点及其实现方式将会变得更加明显,并可更好地理解本发明,其中:
图1和图2为一种外科切割紧固器械的立体图;
图3-5为图1所示器械的端部执行器和轴的分解图;
图6为图3所示的端部执行器的侧视图;
图7为图1所示的器械的柄部的分解图;
图8和图9为图1所示的柄部的局部立体图;
图10为图1所示的柄部的侧视图;
图10A和图10B示出可与图1所示的柄部一起使用的比例传感器;
图11为图1所示器械中使用的电路的示意图;
图12-13为根据其他实施例的外科器械柄部的侧视图;
图14-22示出用于锁定外科器械柄部的闭合扳机的不同机构;
图23A-B示出可用于外科器械的关节点的通用接头(“U型接头”);
图24A-B示出可用于外科器械的关节点的扭缆;
图25-31示出一种带助力的外科切割紧固器械;
图32-36示出根据另一实施例的带助力的外科切割紧固器械;
图37-40示出根据本发明实施例的带触觉反馈的外科切割紧固器械;
图41为一种外科器械的端部执行器和轴的分解图;
图42为一种机械致动的外科器械的柄部的侧视图;
图43为图42所示的机械致动的外科器械的柄部的分解图;
图44为用于记录外科器械的各种状况的记录系统的框图;
图45-46为图42所示器械的柄部的剖切侧视图;
图47示出图42所示器械的端部执行器,示出各种传感器;
图48示出图42所示器械的击发杆,其中包括传感器;
图49为图42所示器械的柄部、端部执行器和击发杆的侧视图,其中示出传感器;
图50为根据本发明各种实施例的器械的钉槽和钉仓各部分的分解图,其中示出各种传感器;
图51为图42所示器械的钉槽的俯视图,其中示出各种传感器;
图52A和图52B示出根据各种实施例的外科器械的操作方法的流程图;
图53为存储表,示出根据各种实施例的外科器械的示例性记录状况;
图54示出根据各种实施例的外科器械;
图55为图54所示外科器械的示意图;
图56-58示出图54所示外科器械的一部分的各种实施方式;
图59为根据本发明的各种实施例的外科器械的立体图;
图60为装于密封容器内的外科器械的图;
图61为根据本发明的各种实施例的包括第一部分和第二部分的外科器械的立体图;
图62为图61的外科器械的立体图,其中根据本发明的各种实施例,第一部分至少部分地位于一腔体内,该腔体限定在第二部分中;
图63为图62的外科器械的闭合构件的示图,该闭合构件设置为接合第一部分并且迫使第一部分进入第二部分中限定的腔体内;
图64为根据本发明的各种实施例的电源的透视图;
图65为根据本发明的各种实施例的另一个电源的透视图;以及
图66为根据本发明的各种实施例的图65的电源沿图65中的线66-66截取的横截面图。
对应参考符号表明贯穿若干视图的对应部分。本发明给出的范例(以一种形式)示出本发明的优选实施例,不应将这些范例理解为是以任何方式限制本发明的范围。
具体实施方式
现在将描述一些示例性实施例以全面理解本申请公开的装置的结构原理、功能、制造和器械用途以及方法。这些实施例的一个或多个实例在附图中示出。本领域的技术人员将会理解,本申请具体描述和在附图中示出的器械和方法为非限制性的示例性实施例,并且本发明多个实施例的范围仅由权利要求书限定。一个示例性实施例示出或描述的特征可与其他实施例的特征组合。这种修改形式和变型形式旨在包括在本发明的范围内。
图1和图2示出根据各种实施例的外科切割紧固器械10。图示实施例是内窥镜式外科器械10,通常,本申请描述的器械10的实施例是内窥镜式外科手术切割和紧固器械。但是,应当指出,根据其他实施例,器械10也可为非内窥镜式外科切割器械,例如为腹腔镜式器械。
图1和图2示出的外科器械10包括柄部6、轴8和在关节枢轴14处可枢转地连接至轴8的关节连接的端部执行器12。关节控制器16可被设置为与柄部6邻近,以使端部执行器12能够绕关节枢轴14旋转。应当理解,不同的实施例可包括非枢转的端部执行器,因此可能不会设有关节枢轴14或关节控制器16。此外,在图示的实施例中,端部执行器12可构造成用于夹紧、切断和缝合组织的内切割器,虽然在其他实施例中可采用不同类型的端部执行器,如用于其他类型的手术器械的端部执行器,例如抓握器、切割器、缝合器、施夹器、进入装置、药物/基因治疗装置,超声波、射频或激光装置等。
器械10的柄部6可包括用来使端部执行器12致动的闭合扳机18和击发扳机20。应当理解,具有涉及不同外科手术任务的端部执行器的器械可具有用于操纵端部执行器12的不同数量或类型的扳机或其它合适的控制器。端部执行器12被显示为优选地通过细长轴8与柄部6分开。在一个实施例中,临床医生或器械10的操作者可利用关节控制器16使端部执行器12相对于轴8进行关节动作,如在2006年1月10日提交的、名称为“SURGICAL INSTRUMENT HAVING AN ARTICULATING ENDEFFECTOR(具有铰接端部执行器的外科器械)”、序列号为11/329,020的未决的美国专利申请中对此作了更详细的描述,该申请的全部公开内容以引证方式并入本申请。
在该实例中,除了别的以外,端部执行器12包括钉槽22和可枢转运动的夹持构件,例如砧板24,其保持在能够确保有效地缝合和切断被夹持在端部执行器12中的组织的距离处。柄部6包括手枪式握把26,由临床医生将闭合扳机18枢转地拉向手枪式握把26,以使砧24朝着端部执行器12的钉槽22夹持或闭合,从而夹持住置于砧板24和钉槽22之间的组织。击发扳机20在闭合扳机18的更外侧。如以下进一步描述的,一旦闭合扳机18被锁定在闭合位置,击发扳机20就可朝着手枪式握把26稍微旋转以使得其可由操作者单手触及到。然后,操作者可将击发扳机20朝着手枪式握把26枢转地拉动以缝合和切断在端部执行器12中夹持的组织。在其它实施例中,可使用除砧板24之外的不同类型的夹持构件,例如,对置的夹具等等。
应当理解,本申请使用的术语“近侧”和“远侧”是相对于握住器械10的柄部6的外科医生而言的。因此,端部执行器12相对于更近侧的柄部6为远侧。还应当理解,为便利和清楚起见,本申请可结合附图使用诸如“垂直”和“水平”之类的空间术语。然而,外科器械在多个取向和位置使用,这些术语并非意图进行限制,也并非绝对。
闭合扳机18可被首先驱动。一旦临床医生对于端部执行器12的设置感到满意,则临床医生可将闭合扳机18拉回至其邻近手枪式握把26的完全闭合、锁定的位置。然后,驱动击发扳机20。当临床医生移除压力时,击发扳机20返回到打开位置(如图1和图2所示),如下面将更全面描述。当压下柄部6上的释放钮时,可释放被锁定的闭合扳机18。释放钮可实现为各种形式,例如图42-43所示的释放钮30、图14所示的滑动释放钮160和/或图16所示按钮172。
图3-6示出根据各种实施例的旋转驱动端部执行器12和轴8的实施方式。图3是根据各种实施例的端部执行器12的分解图。如图示实施例所示,除了先前提到的槽22和砧板24之外,端部执行器12可包括切割器32、滑块33、可拆卸地安装在槽22中的钉仓34和螺杆轴36。例如,切割器械32可为刀。砧板24可在枢轴销25处枢转地打开和关闭,枢轴销25连接于槽22的近端。砧板24还可包括位于其近端的凸块27,所述凸块27插入机械关闭系统(以下进一步描述)的部件中以打开和关闭砧板24。当闭合扳机18被驱动即被器械10的使用者内扳时,砧板24可绕着枢轴销25转入夹紧或关闭位置。如果端部执行器12的夹持令人满意,则操作者可驱动击发扳机20,如以下更详细说明的,使割刀32和滑块33沿着槽22纵向行进,从而切割夹持于端部执行器12中的组织。滑块33沿槽22的移动将钉仓34的缝钉(未示出)推入而穿过切开的组织并撞击在砧板24上,这使缝钉拐弯而将切开的组织紧固。在各种实施例中,滑块33可为钉仓34的一体部件。名称为“SURGICAL STAPLING INSTRUMENTINCORPORATING AN E-BEAM FIRING MECHANISM(结合有E梁击发机构的外科缝合器械)”的美国专利号6,978,921提供了对于这类二行程切割紧固器械的更详细描述,该专利的全部公开内容以引证方式并入本申请。滑块33可为钉仓34的一部分,使得当割刀32在切割操作后回缩时,滑块33不回缩。
应该指出的是,虽然本申请描述的器械10的实施例使用缝合切断的组织的端部执行器12,但是在其它实施例中,可使用用于紧固或密封切断的组织的不同技术。例如,也可使用利用RF能或粘合剂来紧固切断的组织的端部执行器。名称为“ELECTROSURGICAL HEMOSTATIC DEVICE(电外科止血装置)”的美国专利号5,709,680和名称为“ELECTOSURGICALHEMOSTATIC DEVICE WITH RECES SED AND/OR OFFSET ELECTRODES(具有凹入和/或偏移电极的电外科止血装置)”的美国专利号5,688,270公开了一种使用射频能量封闭被切开组织的内窥镜式切割器械,这两个专利的全部公开内容以引证方式并入本申请。名称为“SURGICAL STAPLINGINSTRUMENTS STRUCTURED FOR DELIVERY OF MEDICAL AGENTS(构造成用于递送医疗试剂的外科缝合器械)”、序列号为11/267,811的美国专利申请和名称为“SURGICAL STAPLING INSTRUMENTSSTRUCTURED FOR PUMP-AS SISTED DELIVERY OF MEDICAL AGENTS(构造成用于泵辅助递送医疗试剂的外科缝合器械)”、序列号为11/267,383的美国专利申请公开了使用粘结剂来紧固被切开组织的切割器械,这两个专利申请的全部公开内容以引证方式并入本申请。因此,虽然本申请的描述涉及切割/缝合操作等,但是应当认识到:这仅是示例性实施方式,并不意味着具有限制性。也可使用其他的组织紧固技术。
图4和图5为根据各种实施例的端部执行器12和轴8的分解图,而图6为其侧视图。正如图示实施例中所示,轴8可包括由枢轴连接件44枢转地连接的近侧关闭管40和远侧关闭管42。远侧关闭管42包括开口45,砧板24上的凸块27插入开口45中以打开和关闭砧板24,如下面进一步描述。近侧脊管46可设置在关闭管40、42内。经由锥齿轮组件52与二级(或远侧)传动轴50连接的主旋转(或近侧)传动轴48可设置在近侧脊管46内。二级传动轴50连接至与螺杆轴36的近侧传动齿轮56接合的传动齿轮54。垂直锥齿轮52b可位于近侧脊管46远端的开口57中且能够在其中枢转。远侧脊管58可用来将二级传动轴50和传动齿轮54、56装入。总的来说,主传动轴48、二级传动轴50和关节组件(例如锥齿轮组件52a-c)在本申请中有时称为“主传动轴组件”。
设置在钉槽22远端的轴承38接纳传动螺杆轴36,使得传动螺杆轴36可相对于槽22自由旋转。螺杆轴36可接合割刀32的带螺纹开口(未示出),使得轴36的旋转导致割刀32向远侧或近侧(根据旋转方向)平移穿过钉槽22。因此,当击发扳机20的致动造成主传动轴48旋转(在下面详细解释)时,锥齿轮组52a-c使二级传动轴50旋转,这继而又由于传动齿轮54、56的啮合而导致导致螺杆轴36旋转,这使刀驱动构件32沿槽22纵向行进而切割被夹紧在端部执行器12内的任何组织。滑块33可由(例如)塑料制成,并且可具有倾斜的远侧表面。由于滑块33穿越槽22,其倾斜前表面可上推或驱动钉仓中的缝钉穿过被夹的组织,并撞击到砧板24上。砧板24使缝钉弯折,从而缝合切断的组织。当割刀32回缩时,割刀32和滑块33可变得脱离,从而使滑块33留在槽22的远端。
在某些情况下,医生普遍不太接受只通过按下一个按钮来驱动切割/缝合操作的电动的内切割器,因为缺乏使用者对切割/缝合操作的反馈。相比之下,本申请中公开的某些实施例提供了一种具有对端部执行器12中的切割装置32的调动、加载力和/或位置的反馈的电动端部执行器。
图7-10示出电动端部执行器(特别是其柄部)的示例性实施例,该实施例提供关于端部执行器12中的切割装置32的部署和加载力的使用者反馈。此外,该实施例可利用使用者在拉回击发扳机20时提供的动力来对器械供能(所谓的“助力”模式)。该实施例可与上述的旋转驱动端部执行器12和轴8的实施例一起使用。如图示实施例中所示,柄部6包括外部下侧件59、60和外部上侧件61、62,它们配合在一起在整体上形成柄部6的外部。诸如锂离子电池之类的电池64可设置在柄部6的手枪式握把26中。电池64对设置在柄部6的手枪式握把26上部内的电机65供电。根据各种实施例,电机65可是直流有刷驱动电机,具有约5000RPM的最大转速。电机65可驱动90°锥齿轮组66,所述锥齿轮组包括第一锥齿轮68和第二锥齿轮70。锥齿轮组66可驱动行星齿轮组72。行星齿轮组件72可包括连接至传动轴76的小齿轮74。小齿轮74可驱动与之配合的环形齿轮78,该环形齿轮经传动轴82驱动螺旋形齿轮鼓80。环84可螺旋接合在螺旋齿轮鼓80上。因此,当电机65旋转时,环84利用介于其间的锥齿轮组件66、行星齿轮组件72和环形齿轮78而沿着螺旋形齿轮鼓80行进。
柄部6还可包括一个与击发扳机20通信的运行电机传感器110(见图10),检测出操作者何时已将击发扳机20拉近(或“闭合”)柄部6的握把部26,从而驱动由端部执行器12执行的切割/缝合操作。传感器110可为比例传感器,例如变阻器或可变电阻器。当拉近击发扳机20时,传感器110检测出该移动并发出指示要供给电机65的电压(或功率)的电信号。当传感器110为可变电阻器等时,电机65的转速可与击发扳机20的移动量大致成比例。也就是说,如果操作者仅轻微拉动或者闭合击发扳机20,则电机65的转速较低。当完全拉近击发扳机20(或者处于完全闭合位置)时,电机65的转速为其最大值。换句话讲,使用者越用力拉动击发扳机20,施加到电机65上的电压就越大,从而转速就越大。
柄部6可包括与击发扳机20上部相邻的中间柄部构件104。柄部6还可包括连接在中间柄部构件104上的柱和击发扳机20上的柱之间的偏置弹簧112。偏置弹簧112可将击发扳机20偏置到其完全打开位置。这样,当操作者释放击发扳机20时,偏置弹簧112将击发扳机20拉向其打开位置,由此去除传感器110的驱动,从而停止电机65的旋转。此外,借助于偏置弹簧112,每当使用者闭合击发扳机20时,会感受到对闭合操作的阻力,从而向使用者提供有关电机65所施加的旋转量的反馈。另外,操作者可停止拉回击发扳机20,由此将力从传感器100移除,从而停止电机65。这样,使用者就可停止端部执行器12的调动,从而为操作者提供了对切割/紧固操作进行控制的方式。
螺旋齿轮鼓80的远端包括驱动环形齿轮122的远侧传动轴120,所述环形齿轮122与小齿轮124啮合。小齿轮124连接至主传动轴组件的主传动轴48。这样,电机65的旋转致使主传动轴组件旋转,从而驱动端部执行器12,如上所述。
螺纹接合在螺旋齿轮鼓80上的环84可包括设置在开槽臂90的狭槽88内的柱86。开槽臂90在其相对端94上具有开口92,开口92接纳连接在柄部外侧件59、60之间的枢轴销96。枢轴销96还穿过击发扳机20中的开口100和中间柄部构件104中的开口102而设置。
此外,在柄部6可包括反向电机传感器(或行程结束传感器)130和止动电机(或行程开始)传感器142。在各种实施例中,反向电机传感器130可为位于螺旋齿轮鼓80远端的限位开关,使得螺纹接合在螺旋齿轮鼓80上的环84在其到达螺旋齿轮鼓80的远端时接触并触动反向电机传感器130。反向电机传感器130在启动时向电机65发送信号,以使其旋转反向,从而在切割操作后回缩端部执行器12的割刀32。
止动电机传感器142可为例如常闭限位开关。在各种实施例中,其可位于螺旋齿轮鼓80的近端,使得环84到达螺旋齿轮鼓80的近端时触动开关142。
在操作过程中,器械10的操作者10回拉击发扳机20时,传感器110检测到击发扳机20的调动并向电机65发出信号以使电机65正向旋转,例如使电机以与回拉击发扳机20的力度成比例的速率转动。电机65的正向旋转继而使得行星齿轮组件72的远端处的环形齿轮78旋转,从而使得螺旋形齿轮筒80旋转,使通过螺纹连接在螺旋形齿轮鼓80上的环84沿着螺旋形齿轮鼓80朝远侧行进。螺旋齿轮鼓80的旋转还驱动如上所述的主传动轴组件,这继而使端部执行器12中的割刀32被调动。也就是说,使得割刀32和滑块33纵向穿过槽22,从而切割夹持在端部执行器12中的组织。此外,在使用缝合型端部执行器的实施例中使端部执行器12进行缝合操作。
当端部执行器12的切割/缝合操作完成时,螺旋齿轮鼓80上的环84将已到达螺旋齿轮鼓80的远端,从而使反向电机传感器130被触动,传感器130将信号发送至电机65以使电机65的旋转反向。这继而使得割刀32回缩,并且还使螺旋齿轮鼓80上的环84移回到螺旋齿轮鼓80的近端。
中间柄部构件104包括与开槽臂90接合的后侧肩106,如图8和图9中清晰显示。中间柄部构件104还具有与击发扳机20接合的前移阻挡件107。如以上所解释,开槽臂90的运动受电机65旋转的控制。当开槽臂90随着环84从螺旋齿轮鼓80的近端行走到远端而逆时针旋转时,中间柄部构件104将不受约束而逆时针旋转。因此,当使用者拉近击发扳机20时,击发扳机20将与中间柄部构件104的前移阻挡件107接合,使中间柄部构件104逆时针旋转。然而,由于后侧肩106与开槽臂90接合,中间柄部构件104将只能在开槽臂90许可的范围内逆时针旋转。这样一来,如果电机65出于某种原因停止旋转,则开槽臂90就会停止转动,使用者会无法进一步拉近击发扳机20,因为中间柄部构件104由于开槽臂90的约束而不能自由逆时针转动。
图10A和图10B示出变量传感器的两个状态,该传感器可用作运行电机传感器110。传感器110可包括表面部280、第一电极(A)282、第二个电极(B)284以及电极282、284之间的可压缩电介质材料286,例如电活性聚合物(electoactive polymer,EAP)。传感器110可设置成在回缩时使表面部分280接触击发扳机20。因此,当击发扳机20缩回,电介质材料286被压缩,如图10B所示,使电极282、284一起靠得更近。电极282、284之间的距离“b”直接关系到电极282、284之间的阻抗,距离越大阻抗越大,距离越小阻抗就越小。这样,由于击发扳机20的拉回而使电介质286被压缩的量(图42中以力“F”表示)与电极282、284之间的阻抗成比例,这可用于按比例控制电机65。
图7-10中还显示了用于通过回缩闭合扳机18来闭合(或夹持)端部执行器12的砧板24的示例性闭合系统的部件。在图示实施例中,该闭合系统包括一个通过枢轴销251连接于闭合扳机18的轭形件250,所述枢轴销251被插入对准的位于闭合扳机18和轭形件250这二者上的开口。闭合扳机18绕枢轴销252枢转,并且枢轴销252插入穿过闭合扳机18中的另一开口,该开口偏离销251插入穿过闭合扳机18的位置。因此,闭合扳机18的回缩导致闭合扳机18的上部逆时针旋转,轭形件250通过销251连接于闭合扳机18。轭形件250的远端通过销254连接至第一闭合托架256。第一闭合托架256连接至第二闭合托架258。闭合托架256、258共同限定开口,近侧关闭管40(见图4)的近端安放并保持在该开口中,使得闭合托架256、258的纵向移动引起近侧关闭管40的纵向移动。器械10还包括设置在近侧关闭管40内部的闭合杆260。闭合杆260可包括窗口261,位于柄部外部件之一(例如图示实施例中的外部下侧件59)上的支柱263设置在窗口261中,以将闭合杆260固定连接至柄部6。这样,近侧关闭管40能够相对于闭合杆260纵向移动。闭合杆260还可包括远侧轴环267,其装配在近侧脊管46中的腔269内并由帽271(见图4)保持在腔内。
在操作中,当轭形件250由于闭合扳机18的回缩而旋转时,闭合托架256、258导致近侧关闭管40向远侧移动(即远离器械10的柄部端),这会导致远侧关闭管42向远侧移动,从而导致砧板24绕枢轴销25旋转到夹紧或关闭位置。当闭合扳机18被从锁设置置释放时,近侧关闭管40因此向近侧滑动,从而导致远侧关闭管42向近侧滑动,凭借插入于远侧关闭管的开口45的凸块27,这使得砧板24绕枢轴销25枢转至打开或松开位置。这样,通过回缩并锁定闭合扳机18,操作者可将组织夹持在砧板24和槽22之间,并能够在切割/缝合操作后通过将闭合扳机20从锁设置置释放来松开该组织。
图11是根据本发明各种实施例的器械10的电路的示意图。当操作者在锁定闭合扳机18后开始拉近击发扳机20时,传感器110被激活,从而使电流从中流过。如果常开电机反转传感器开关130打开(表明还未到达端部执行器行程的末尾),电流将流向单刀双掷继电器132。由于电机反转传感器开关130未闭合,所以继电器132的电感器134不通电,因此继电器132将处于其未通电状态。该电路还包括钉仓闭锁传感器136。如果端部执行器12包括钉仓34,则传感器136将处于闭合状态,从而使电流流动。相反,如果端部执行器12不包括钉仓34,则传感器136断开,从而防止电池64向电机65供电。
当钉仓34存在时,传感器136闭合,为单刀单掷继电器138供电。当为继电器138供电时,电流流经继电器136,流过可变电阻器传感器110,并经由双刀双掷继电器140到达电机65,从而为电机65供电并使其正向旋转。
当端部执行器12达到其行程末尾时,反向电机传感器130被激活,从而闭合开关130并为继电器134供电。这使继电器134处于其通电状态(图13中未示出),使电流不通过钉仓闭锁传感器136和可变电阻器110而流向常闭双刀双掷继电器142并流回电机65,但是以导致电机65反向旋转的方式经过继电器140。
因为止动电机传感器开关142是常闭的,因此电流将流回到继电器134以保持其闭合,直到开关142断开。当割刀32完全回缩时,止动电机传感器开关142被激活,导致开关142断开,从而将电机65断电。
在其他实施例中,可使用通断型传感器而不是比例型传感器110。在此类施例中,电机65的转速将不与操作者施加的力成比例。确切地讲,电机65一般以恒速旋转。但是因为击发扳机20与齿轮传动系接合,所以操作者仍将感受到力反馈。
图12为根据另一实施例的助力电动内切割器的柄部6的侧视图。图12的实施例与图7-10的实施例类似,不同的是:图12的实施例中不存在与螺纹接合在螺旋齿轮鼓80上的环84连接的开槽臂。在图12的实施例中,代之以环84包括当环84在螺旋齿轮鼓80上向下(和向后)行进时随环84一起移动的传感器部分114。传感器部分114包括凹口116。反向电机传感器130可位于凹口116的远端,并且止动电机传感器142可位于凹口116的近端。当环84在螺旋齿轮鼓80上向下(和向后)移动时,传感器部分114与其一起移动。此外,如图12所示,中间件104可具有延伸到凹口12中的臂118。
在操作中,当器械10的操作者朝手枪式握把26拉回击发扳机20时,运转电机传感器110检测到该运动并发送信号以向电机65供电,此外,这还使螺旋齿轮鼓80旋转。当螺旋齿轮鼓80旋转时,螺纹接合在螺旋齿轮鼓80上的环84前进(或者后退,具体取决于旋转方向)。此外,由于击发扳机20的向内扣动,因此,中间柄部构件104由于与击发扳机20接合的前移阻挡件107而随击发扳机20逆时针旋转。中间柄部构件104的逆时针旋转导致臂118随着环84的传感器部分114逆时针旋转,致使臂118保持留置在凹口116内。当环84到达螺旋齿轮鼓80的远端时,臂118将接触并从而触动反向电机传感器130。相似地,当环84到达螺旋齿轮鼓80的近端时,臂将接触并从而触动止动电机传感器142。这类动作会分别使电机65反转和停止,如上分别所述。
图13为根据另一实施例的助力电动内切割器的柄部6的侧视图。图13的实施例类似于图7-10的实施例,不同的是在图13的实施例中,臂90中没有槽。相反,螺纹接合在螺旋齿轮鼓80上的环84包括垂直导槽126。臂90包括设置在导槽126中的柱128来代替狭槽。当螺旋齿轮鼓80旋转时,螺纹接合在螺旋齿轮鼓80上的环84前进(或者后退,具体取决于旋转方向)。由于柱128设置在导槽126中,臂90随着环84的前进而逆时针旋转,如图13所示。
如上所述,在使用双行程电动器械时,操作者首先向后拉动并锁定闭合扳机18。图14和图15示出了将闭合扳机18锁定在柄部6的手枪式握把26上的方式的一个实施例。在图示实施例中,手枪式握把26包括挂钩150,其因扭转弹簧152的作用而偏向于绕枢轴点151逆时针旋转。此外,闭合扳机18包括闭合杆154。操作者将闭合扳机18回扣时,闭合杆154与挂钩150的倾斜部分156接合,从而挂钩150向上(即图14-15中的顺时针方向)旋转,直至关闭杆154完全通过倾斜部分156并进入凹进的缺口158,从而将闭合扳机18锁定到位。操作者可通过下推位于手枪式握把26的后侧或对侧上的滑动释放钮160来释放闭合扳机18。推下滑动释放钮160使挂钩150顺时针转动,从而使闭合杆154从凹进的缺口158释放。
图16示出根据各种实施例的另一种闭合扳机锁定机构。在图16的实施例中,闭合扳机18包括具有箭头部分161的楔形件160。箭头部分161被片簧162向下(即顺时针方向)偏压。楔形件160和片簧162可由例如模制塑料制成。当闭合扳机18回缩时,箭头部分161能够从柄部6的手枪式握把26中的开口164插入。箭头部分161的下部斜面166与开口164的下侧壁168接合,迫使箭头部分161逆时针旋转。最后,下部斜面166完全通过下侧壁168,作用于箭头部分161的逆时针转动力被消除,从而使下侧壁168滑入箭头部分161后面的缺口170中的锁设置置。
要释放闭合扳机18的锁定,使用者可按下闭合扳机18的相对侧上的按钮172,使箭头部分161逆时针旋转,并让箭头部分161滑出开口164。
图17-22示出根据另一个实施例的闭合扳机锁定机构。如该实施例中所示,闭合扳机18包括纵向柔性臂176,纵向柔性臂176包括从其中伸出的侧销178。臂176和销178可由例如模制塑料制成。柄部6的手枪式握把26包括开口180,开口180具有设置在其中的横向延伸的楔形件182。当闭合扳机18回扣时,销178与楔形件182接合,并且销178被楔形件182的下表面184压下(即臂176顺时针转动),如图17和18所示当销178完全通过下表面184,臂176上顺时针方向作用力被去除,于是销178逆时针转动,使得销178终于落入楔形件182后的缺口186中,从而锁定闭合扳机18,如图19所示。销178进一步通过从楔形件184伸出的柔性阻挡件188保持在锁设置置中。
为了将闭合扳机18释放,操作者可进一步按压闭合扳机18,使销178接合在开口180的倾斜后壁190上,促成销178向上越过柔性阻挡件188,如图20和图21所示。销178然后不受约束而在开口180中移出上部导槽192,使得闭合扳机18不再锁定在手枪式握把26上,如图22所示。
图23A-B示出通用接头(“U型接头”)195。U型接头195的第二构件195-2在水平面上旋转,第一构件195-1位于该水平面中。图23A示出直线(180°)取向的U型接头195,图23B示出呈大约150°取向的U型接头195。能够在主传动轴组件的关节点14处用U型接头195代替锥齿轮52a-c(例如见图4),以使端部执行器12进行关节活动。图24A-B示出扭转缆线197,其可用于代替锥齿轮52a-c和U型接头195,以实现端部执行器12的关节连接。
图25-31示出带助力的电动双行程外科切割紧固器械10的另一个实施例。图25-31的实施例类似于图6-10的实施例,不同的是图23-28的实施例包括替代的齿轮驱动组件,而不是螺旋齿轮鼓80。图25-31的实施例包括齿轮箱组件200,其包括设置在机架201中的数个齿轮,其中这些齿轮连接在行星齿轮72与传动轴48近端处的小齿轮124之间。如下面进一步解释,齿轮箱组件200通过击发扳机20为使用者提供有关端部执行器12的调动和加载力的反馈。而且,使用者可通过齿轮箱组件200为系统提供动力,以辅助端部执行器12的调动。从这个意义上说,类似于如上所述的实施例,图23-32的实施例是另一种助力电动器械10,其可向使用者提供关于器械所受到的加载力的反馈。
在图示实施例中,击发扳机20包括两个部分:主体部分202和刚性部分204。主体部分202可由例如塑料制成,而刚性部分204可由更刚硬的材料(如金属)制成。在图示实施例中,刚性部分204与主体部分202相邻,但根据其他实施例,刚性部分204可设置在主体部分202的内部。枢轴销207可插入穿过击发扳机构件202、204中的开口,并可为击发扳机20绕其旋转的点。此外,弹簧222可导致闭合扳机20偏向逆时针旋转。弹簧222可具有连接至销224的远端,销224连接至击发扳机20的构件202、204。弹簧222的近端可连接至柄部外部下侧件59、60中的一者。
在图示实施例中,主体部分202和刚性部分204两者在其上端部分(分别)包括齿轮部206、208。齿轮部206、208接合齿轮箱组件200中的齿轮(如下面所解释),以驱动主传动轴组件并为使用者提供有关端部执行器12调动的反馈。
在图示实施例中示出,齿轮箱组件200可包括六(6)个齿轮。齿轮箱组件200的第一齿轮210与击发扳机20的齿轮部206、208啮合。此外,第一齿轮210啮合更小的第二齿轮212,更小的第二齿轮212与大的第三齿轮214共轴。第三齿轮214啮合更小的第四齿轮216,更小的第四齿轮与第五齿轮218共轴。第五齿轮218为90°锥齿轮,其啮合连接至小齿轮124的配对的90°锥齿轮220(图31中清晰示出),小齿轮124驱动主传动轴48。
在操作时,当使用者拉回击发扳机20时,运转电机传感器(未示出)被激活,其可向电机65提供信号,使之以与操作者拉回击发扳机20的程度或者力成比例的速度旋转。这使得电机65以与来自传感器的信号成比例的速度旋转。此实施例中未示出传感器,但可类似于上述的运转电机传感器110。传感器可位于柄部6中,使得其在击发扳机20拉回时被压缩。此外,可用通/断型传感器来代替比例型传感器。
电机65的旋转使锥齿轮68、70转动,这导致行星齿轮72转动,从而通过传动轴76使环形齿轮122旋转。环形齿轮122与小齿轮124啮合,所述小齿轮124连接于主传动轴48。因此,小齿轮124的旋转驱动主传动轴48,这导致端部执行器12的切割/缝合操作。
小齿轮124的向前旋转又导致锥齿轮220旋转,从而通过齿轮箱组件200的其他齿轮使第一齿轮210旋转。第一齿轮210与击发扳机20的齿轮部分206、208啮合,从而在电机65对端部执行器12提供向前驱动时使击发扳机20逆时针转动(并且在电机65反转而撤回端部执行器12时逆时针转动)。这样,使用者通过其握持击发扳机20来感受有关端部执行器12的加载力和调动的反馈。因此,当使用者拉回击发扳机20时,操作者将感受到与端部执行器12受到的加载力有关的阻力。同样地,在切割/缝合操作后操作者将击发扳机20释放以使其返回到原来位置,使用者将体验到来自击发扳机20的大致与电机65的反向速度成正比的顺时针旋转力。
还应该指出的是,在此实施例中,使用者可施加力(代替或补充来自电机65的力)以通过拉回击发扳机20来驱动主传动轴组件(由此驱动端部执行器12的切割/缝合操作)。也就是说,拉回击发扳机20使齿轮部分206、208逆时针旋转,使齿轮箱组件200的齿轮旋转,从而使小齿轮124旋转,这将导致主传动轴48旋转。
尽管在图25-31中未示出,但是器械10还可包括反向电机传感器和止动电机传感器。如上所述,反向电机传感器和止动电机传感器可分别检测切割行程的结束(割刀32完全伸出)和回缩操作的结束(割刀32完全缩回)。与上述图11相关的电路的类似电路可用于为电机65适当供电。
图32-36示出根据另一个实施例的带助力的双行程电动外科切割紧固器械10。图32-36的实施例类似于图25-31的实施例,不同的是在图32-36的实施例中,击发扳机20包括下部228和上部230。下、上部228、230两者均与穿过上、下部228、230设置的枢轴销207连接并绕其枢转。上部230包括与齿轮箱组件200的第一齿轮210啮合的齿轮部232。弹簧222连接于上部230,使上部受到顺时针旋转的偏向力。上部230可还包括与击发扳机20的下部228的上表面接触的下臂234,这样,当上部230因此以顺时针旋转时下部228也顺时针转动,并且当下部228逆时针旋转时上部230也逆时针旋转。同样,下部228包括与上部230的肩部接合的旋转止挡238。由此,当上部230因此逆时针旋转时下部228也逆时针旋转,并且当下部228顺时针旋转时上部230也顺时针旋转。
图示实施例还包括给电机65传送信号的运转电机传感器110,在各种实施例中,该信号可使电机65以与操作者拉回击发扳机20时施加的力成比例的速度旋转。传感器110可为(例如)变阻器或某些其他可变电阻传感器,如本申请所述。此外,器械10可包括反向电机传感器130,其在与击发扳机20的上部230的正面242触碰时触动或切换。当被激活时,反向电机传感器130将信号发送至电机65,以使其反向。此外,器械10可包括在与击发扳机20的下部228接触时触动或驱动的止动电机传感器142。当被激活时,止动电机传感器142发送信号以停止电机65的反向旋转。
在操作中,当操作者将闭合扳机18扣回到锁设置置,击发扳机20稍有回缩(这借助于本领域所知的机构,其中包括名称为“SURGICALSTAPLING INSTRUMENT INCORPORATING AN E-BEAM FIRINGMECHANISM(结合有E梁击发机构的外科缝合器械)”的美国专利号6,978,921和名称为“SURGICAL STAPLING INSTRUMENTINCORPORATING A FIRING MECHANISM HAVING A LINKED RACKTRANSMISSION(结合有具有连接齿条传动装置的击发机构的外科缝合器械)”的美国专利No.6,905,057,这两个专利的全部公开内容以引证方式并入本申请),因此使用者可握住击发扳机20来开始切割/缝合操作,如图32和图33所示。此时,如图33所示,击发扳机20上部230的齿轮部232移动至与齿轮箱组件200的第一齿轮210啮合。当操作者拉回击发扳机20时,根据各种实施例,在触动运转电机传感器110之前,击发扳机20可旋转较小的量(例如5度),如图34中所示。传感器110的激活使电机65以与由操作者施加的回拉力成比例的速度正向旋转。如上所述,电机65正向旋转引起主传动轴48旋转,这使得端部执行器12中的割刀32被调动(即开始穿过槽22)。连接至主传动轴48的小齿轮124的旋转导致齿轮箱组件200中齿轮210-220旋转。由于第一齿轮210与击发扳机20的上部230的齿轮部分232啮合,上部232因此逆时针旋转,这导致下部228也逆时针旋转。
当割刀32的调动完成(即在切割行程结束)时,上部230的正面242触动反向电机传感器130,反向电机传感器130将信号发送至电机65,使其反方向旋转。这使得主传动轴组件反方向旋转以回缩割刀32。主传动轴组件的反转也导致齿轮箱组件中齿轮210-220换向,使击发扳机20的上部230顺时针旋转,这将导致击发扳机20的下部228顺时针旋转,直到割刀32完全缩回时下部228触动或驱动止动电机传感器142,从而使电机65停止。这样,使用者通过其握持击发扳机20感受到有关端部执行器12调动的反馈。因此,当使用者拉回击发扳机20时,操作者将感受到与端部执行器12的调动有关的阻力,特别是与由于割刀32受到的加载力有关的阻力。同样地,在切割/缝合操作后操作者将击发扳机20释放以使其返回到原来位置,使用者将体验到来自击发扳机20的大致与电机65的反向速度成正比的顺时针旋转力。
还应该指出的是,在此实施例中,使用者可施加力(代替或补充来自电机65的力)以通过拉回击发扳机20来驱动主传动轴组件(由此驱动端部执行器12的切割/缝合操作)。也就是说,回扣击发扳机20导致上部230的齿轮部分232逆时针旋转,这使齿轮箱组件200的齿轮旋转,从而使小齿轮124旋转,这又使主传动传动轴组件旋转。
以上所述的实施例采用助力用户反馈系统,其中带或不带用于二行程电动手术切割紧固器械的自适应控制(例如,在电机65、齿轮传动系和端部执行器12的闭环系统之外使用传感器110、130和142)。也就是说,由于击发扳机20被(直接或间接地)啮合到电机65和主传动轴48之间的齿轮传动系中,由使用者施加的用以回扣击发扳机20的力可添加到由电机65施加的力上。在其他实施例中,可向使用者提供有关端部执行器中割刀32位置的触觉反馈,但未使击发扳机20啮合到齿轮传动系中。图37-40示出具有此类触觉位置反馈系统的电动外科切割紧固器械。
在图37-40示出的实施例中,击发扳机20可具有下部228和上部230,类似于图32-36中示出的器械10。然而,不同于图32-36的实施例,上部230不具有与部分齿轮传动系啮合的齿轮部。作为替代,该器械包括第二电机265,第二电机265带有螺纹接合在其中的螺杆266。当电机265旋转时,螺杆266纵向往复进出(取决于旋转方向)电机265。器械10还包括编码器268,其响应主传动轴48的旋转,将主传动轴48(或主传动轴组件的其他部件)的增量角运动转化成(例如)对应的一系列数字信号。在图示实施例中,小齿轮124包括连接至编码器268的近侧传动轴270。
器械10还包括可使用微控制器或一些其他类型的集成电路实现的控制电路(未示出),该控制电路接收来自编码器268的数字信号。根据来自编码器268的信号,控制电路可计算端部执行器12中割刀32调动的阶段。也就是说,控制电路可计算割刀32是否完全调动、完全缩回或者处于中间阶段。根据对端部执行器12调动阶段的计算结果,控制电路可将信号发送至第二电机265以控制其旋转,从而控制螺杆266的往复运动。
在操作中,如图37所示,当闭合扳机18未锁定到夹持位置时,击发扳机20旋转离开柄部6的手枪式握把26,使得击发扳机20的上部230的正面242不与螺杆266的近端接触。当操作者拉回闭合扳机18并将其锁定在夹持位置时,击发扳机20略微朝闭合扳机18旋转,使操作者可握持击发扳机20,如图38所示。在此位置,上部230的正面242接触螺杆266的近端。
作为使用者,然后回扣击发扳机20,在经过最初的旋转量(例如5度的旋转)后运行电机传感器110可被激活,如上面所解释,传感器110发送信号到电机65以使它以与操作者加于击发扳机20的回扣力成比例的速度正向转动。电机65的正向旋转通过齿轮传动系引起主传动轴48旋转,这使得割刀32和滑块33沿着槽22移动并切割夹持在端部执行器12中的组织。控制电路接收来自编码器268的关于主传动轴组件的增量旋转的输出信号,将信号发送到第二电机265以使第二电机265旋转,使导致螺杆266回缩进电机265。这使得击发扳机20的上部230能够逆时针旋转,从而让击发扳机的下部228也逆时针旋转。这样,由于螺杆266的往复运动与主传动轴组件的旋转相关,器械10的操作者能够通过他/她握持击发扳机20来感受有关端部执行器12位置的触觉反馈。然而,由使用者施加的回缩力不直接影响主传动轴组件的驱动,因为击发扳机20并未啮合到该实施例中的齿轮传动系中。
通过对来自编码器268的输出信号对主传动轴组件的增量旋转进行跟踪,控制电路可计算割刀32何时被完全调动(即完全伸展)。此时,控制电路可将信号发送至电机65以反转方向,从而使割刀32回缩。电机65反转方向使主传动轴组件反向旋转,这也被编码器268检测。根据编码器268检测到的反向旋转,控制电路将信号发送至第二电机265以使其反转,使得螺杆266开始从电机265纵向延伸。该转动迫使击发扳机20的上部230顺时针旋转,从而导致下部228顺时针旋转。这样,操作者可体验到来自击发扳机20的顺时针旋转力,这给操作者提供了关于端部执行器12中割刀32的回缩位置的反馈。控制电路可确定割刀32何时完全缩回。此时,控制电路可将信号发送至电机65以使其停止旋转。
根据其他实施例,可使用反向电机传感器和止动电机传感器而不是用控制电路来确定割刀32的位置,如上所述。此外,可使用通/断开关或传感器而不是用比例传感器110来控制电机65的旋转。在此类实施例中,操作者不能控制电机65的转速。确切地说,电机会以预编程的速度旋转。
图41-43示出机械驱动内切割器的示例性实施例,特别是其柄部6、轴8和端部执行器12。关于机械驱动内切割器的更多细节可见名称为“MULTI-STROKE FIRING MECHANISM WITH AUTOMATIC END OFSTROKE RETRACTION(自动结束行程缩回的多行程击发机构)”的美国专利号7,083,075,其全部公开内容以引证方式并入本申请。参照图41,端部执行器12响应来自柄部6闭合运动(图41中未示出),首先通过包括砧面1002连接到砧板近端1004来响应,所述砧板近端1004包括位于垂直突出的砧板凸块27的近侧的侧向突出的砧板枢轴销25。砧板枢轴销25在钉槽22中的肾形开口1006内移动,以相对于槽22打开和关闭砧板24。凸块27接合于弯片1007,所述弯片向内伸入关闭管1005的远端1008上的凸块开口45,所述关闭管在远侧终止于远侧边缘1008,所述远侧边缘压靠在砧板端面1002上。因此,当关闭管1005从其开口位置向近侧移动,关闭管1005的弯片1007将砧板凸块27拉向近侧,并且砧板枢轴销25沿着钉槽22中的肾形开口1006移动,使得砧板24同时地向近侧移动并向上旋转至打开位置。当关闭管1005向远侧移动,凸块开口45中的弯片1007从砧板凸块27释放,其远侧边缘1008压在砧板端面1002上,将砧板24关闭。
继续参照图41,轴8和端部执行器12还包括响应击发杆1010的击发运动的部件。特别是,击发杆1010可旋转地接合于具有纵向凹缝1014的击发槽构件1012。击发槽构件1012直接响应击发杆1010的纵向移动,在框架1016内纵向移动。关闭管1005中的纵向狭槽1018可操作地连接于柄部6的右外侧和左外侧柄构件61、62(图41中未示出)。关闭管1005中的纵向狭槽1018的长度足够长,允许相对于柄构件61、62的纵向移动以分别完成击发和关闭运动,柄构件61、62的结合通过框架1016中的纵向狭槽1020传递,以与框架槽构件1012中的纵向凹缝1014滑动接合。
框架槽构件1012的远端连接于在框架1016内(特别是在导轨1024内)移动的击发杆1022的近端,以将割刀32向远侧伸入端部执行器12。端部执行器12包括由割刀32驱动的钉仓34。钉仓34具有托盘1028,其中容纳钉仓主体1030、楔形滑块驱动头(wedge sled driver)33、缝钉起子(staple drivers)1034和缝钉1036。应当理解,楔形滑块驱动头33可在位于钉仓托盘1028和钉仓主体1030之间的击发凹缝(未图示)内纵向移动。楔形滑块驱动头33呈现凸轮面,这些凸轮面触及并托起缝钉驱动器1034,驱动缝钉1036。钉仓主体1030还包括在近侧开口的垂直槽1031,用作割刀32的通道。具体而言,沿着割刀的远端32设有切割面1027,在组织被缝合后切割组织。
应当理解,图4中轴8被示出为非关节轴。但是,应用可包括能够进行铰接运动的器械,例如参考图1-4所示的器械,以及以下的美国专利和专利申请中所述的器械,其公开全部内容以引证方式并入:(1)美国专利号7,111,769,名称为“SURGICAL INSTRUMENT INCORPORATING ANARTICULATION MECHANISM HAVING ROTATION ABOUT THELONGITUDINAL AXIS(结合有绕纵向轴线旋转的铰接机构的外科器械)”;(2)美国专利号6,786,382,名称为“SURGICAL STAPLINGINSTRUMENT INCORPORATING AN ARTICULATION JOINT FOR AFIRING BAR TRACK(结合有用于击发棒轨道的铰接接头的外科缝合器械)”;(3)美国专利号6,981,628,名称为“A SURGICALINSTRUMENT WITH A LATERAL-MOVING ARTICULATION CONTROL(具有侧向运动铰接控制的外科器械)”;(4)美国专利号7,055,731,名称为“SURGICAL STAPLING INSTRUMENT INCORPORATING ATAPERED FIRING BAR FOR INCREASED FLEXIBILITY AROUND THEARTICULATION JOINT(结合有锥形击发杆以增大绕铰接接头的柔性的外科缝合器械)”;以及(5)美国专利号6,964,363,名称为“SURGICALSTAPLING INSTRUMENT HAVING ARTICULATION JOINT SUPPORTPLATES FOR SUPPORTING A FIRING BAR(具有用于支撑击发杆的铰接接头支撑板的外科缝合器械)”。
图42-43示出了柄部6的实施例,该柄部能够与以上图41所示的轴8和端部执行器12的实施例一起用于一种机械驱动的内切割器。应当理解,任何合适的柄部设计都可用来机械地闭合并击发端部执行器12。图42-43中,外科缝合切割器械10的柄部6包括联动击发机构(linked transmissionfiring mechanism)1060,该机构具有增大力量、减小柄部尺寸、最小化约束力等特点。
端部执行器12(图42-43中未示出)的闭合通过将闭合扳机18朝柄部6的手枪式握把26按压而实现。闭合扳机18绕枢轴销252枢转,所述枢轴销连接于柄部6的左、右外部下侧件59、60,导致闭合扳机18的上部1094向前移动。关闭管1005经关闭轭250接收该闭合运动,关闭轭250通过关闭轭销1044和关闭联接销1046分别与关闭联接件1042和闭合扳机18的上部1094销连接。
在图42所示的完全打开位置,闭合扳机18的上部1094触及并保持处于所示位置的枢转关闭释放钮30的锁臂1048。在闭合扳机18达到其完全按下的位置时,闭合扳机18释放锁臂1048并且其紧靠面1050转入与枢转锁臂1048的远侧右向凹口1052接合,将闭合扳机18保持在其夹紧或关闭位置。锁臂1048的近端与件59、60一起绕侧向枢转连接件1054枢转,将关闭释放钮30露出。关闭释放钮30的中间远侧1056被压簧1058向近侧推压,该压簧在壳体结构1040和关闭释放钮30之间被压缩。其结果是,关闭释放钮30将锁臂1048逆时针(从左侧看)推至与闭合扳机18的紧靠面1050锁定接触,从而防止在联动击发系统1040处于未回缩状态时闭合扳机18松开。
在闭合扳机18缩回并完全按下的情况下,击发扳机20被解锁并在本实施例中可被压向手枪式握把26多次,以使端部执行器12击发。如所描述,联动击发机构1060最初被回缩,受到拉伸/压缩组合弹簧1062的作用而保持在位,所述组合弹簧约束在柄部6的手枪式握把26内,其非移动端1063连接于构件59、60,其移动端1064连接于钢带1066的向下弯折的近侧收尾端1067。
钢带1066的远侧端1068连接于承受结构负载的联接构件1070,其继而又连接于多个环节1072a-1072d中的前面环节1072a,这些环节形成链接齿条1074。链接齿条1074是柔性的,但其具有形成直刚性齿条组件的远侧环节,该齿条组件可通过轴6中的击发杆1010传递有效的击发力,然而可容易地收回到手枪式握把26内,以将柄部6的纵向长度最小化。应当理解,拉伸/压缩组合弹簧1062可增大有效的击发行程,同时基本上将最短长度缩减到单根弹簧的一半。
击发扳机20绕击发扳机销钉96枢转,该销钉连接于柄构件59、60。当击发扳机20向手枪式握把26按压时击发扳机20的上部228绕着击发扳机销钉96向远侧移动,将设置在远侧的击发扳机拉簧222拉长,该拉簧的远端连接在击发扳机20的上部228和件59、60之间。在每次通过附着偏置机构1078执行的击发扳机按压时击发扳机20的上部228与链接齿条1074接合,在击发扳机20被释放时附着偏置机构1078也脱开接合。击发扳机拉伸弹簧222在击发扳机20被释放时将其拉至远侧,并脱开附着偏置机构1078。
当联动击发机构1040启动时,惰轮1080因与链接齿条1074啮合而顺时针旋转(从左侧看)。该旋转连接到指示器齿轮1084,其反应于惰轮1080作逆时针旋转。惰轮1080和指示器齿轮1084均与柄部6的构件59、60可转动地连接。链接齿条1074、惰轮1080和指示器齿轮1084之间的关系可有利地进行选择,以使上部齿面1082具有强度适当的齿尺寸,并且在联动击发机构1060的整个击发行程中指示器齿轮1084的转动不超过一圈。
如下面更详细描述,指示器齿轮1084执行至少四个功能。首先,当链接齿条1074完全缩回并且两个扳机18、20均如图42所示处于张开状态时,指示器齿轮1084左侧的圆形脊1088中的开口1086呈现给锁臂1048的上表面1090。锁臂1048因触及闭合扳机18而偏置进开口1086,闭合扳机继而又被闭合拉簧1092拉至其张开位置。闭合扳机拉簧1092近端地连接于闭合扳机18的上部1094和柄构件59、60,因而在闭合扳机18的关闭过程中使能量被存储,该能量促使闭合扳机18向远侧回到其非关闭位置。
指示器齿轮1084的第二个功能是:其连接在设于柄部6外侧的指示回缩旋钮1096上。因此,指示器齿轮1084将击发机构1060的相对位置传递给回缩旋钮1096,使外科医生得到关于需要多少个击发扳机20的行程来完成击发的视觉指示。
指示器齿轮1084的第三个功能是:在外科缝合切割器械10被操作时纵向和成角度地移动止退机构(单向离合器机构)1097的止退释放杆1098。在击发行程中,止退释放杆1098因指示器齿轮1084向近侧移动,从而启动止退机构1097,以允许击发杆1010向远侧移动并防止击发杆1010向近侧移动。此运动也将止退释放按钮1100从柄构件59、60的近端伸出,以供操作者在击发行程期间需要让联动击发机构1060回缩时按动。击发行程完成后,指示器齿轮1084由于击发机构1060回缩而改变旋转方向。反向转动将止退机构1097释放,将止退释放按钮1100缩回柄部6内,并将止退释放杆1098转至右侧,以使指示器齿轮1084能够继续反向旋转。
指示器齿轮1084的第四个功能是:接受经由指示回缩旋钮1096(如图42所示的顺时针方向)的手动旋转,在止退机构1097解锁的情况下将击发机构1060缩回,从而克服击发机构1060中的任何约束,该约束不容易为拉伸/压缩组合弹簧1062所克服。在击发机构1060部分击发后可使用人力辅助回扣,否则这会被将止退释放按钮1100回缩的止退机构1097阻止,因此止退释放按钮1100不会将止退释放杆1098侧向移动。
继续参照图42-43,止退机构1097由操作者可触及的止退释放杆1098构成,所述止退释放杆可操作地在其近端连接于止退释放按钮1100并在其远端连接于止退轭1102。具体而言,止退释放杆1098的远端1099通过止退轭销钉1104接合于止退轭1102。止退轭1102纵向移动,以将转动传递至止退凸轮槽管1106,所述槽管被柄构件59、90在纵向上约束,并且在发射杆1010至链接齿条1074的联接构件1070的连接部的远侧将击发杆1010围住。止退轭1102将来自止退释放杆1098的纵向移动通过凸轮槽管销1108传递给止退凸轮槽管1106。也就是说,凸轮槽管销1108在止退凸轮槽管1106的斜向槽中的纵向运动,使止退凸轮槽管1106转动。
止退压簧1110、止退片1112和止退凸轮管1114,分别被限制在框架1016的近端和止退凸轮槽管1106之间。如以上描述的,击发杆1010的近侧移动导致止退片1112将顶部枢转到后方,呈现出对于击发杆1010增大的摩擦接触,这可阻止击发杆1010的进一步近侧移动。
当止退凸轮槽管1106与止退凸轮管1114相隔很近时,这种止退片1112以类似于可保持卷帘门打开的卷帘门门锁的方式枢转。具体而言,止退压簧1110能够作用于止退片1112的顶面,将止退片1112倾翻到其锁设置置。止退凸轮槽管1106的旋转导致止退凸轮管1114的远侧凸轮运动,从而对止退片1112的顶部向远侧加力,克服来自止退压簧1110的力,从而将止退片1112设置在非倾(垂直)、未锁设置置,使击发杆1010能够向近侧回缩。
特别参照图43,附着偏置机构1078被图示为由具有向远侧突出的窄尖1118的棘爪1116和在其近端向右侧突出的侧销1120组成,该侧销可旋转地插入位于击发扳机20的上部230的孔眼1076。在击发扳机20的右侧,侧销1120接受图示出为偏置轮1122的偏置构件。由于击发扳机20从头到尾的移动,偏置轮1122在柄部6的右半构件59近侧的弧线上往返移动,在行程的远侧段越过偏置坡道1124,所述偏置坡道一体地形成在右半构件59中。有利地,偏置轮1122可用弹性、摩擦材料形成,这种材料可导致棘爪1116的侧销1120逆时针旋转(从左侧看),从而牵引向下偏置向远侧突出的窄尖1118,进入最近的环节1072a-d的斜坡中央轨道1075而与链接齿条1074接合。
由于击发扳机20被释放,偏置轮1122因此牵引地将棘爪1116偏置到相反方向,将窄尖1118从链接齿条1074的斜坡中央轨道1075抬起。为了确保在高载荷状况下及在棘爪1116的接近全部的远侧行程处脱开尖端1118,棘爪1116的右侧跃上位于关闭轭250右侧的面向远侧和上侧的斜面1126,将窄尖1118从斜坡中央轨道1075脱开。如果击发扳机20在全行程以外的任何点上被释放,偏置轮1122就用来将窄尖1118从斜坡中央轨道1075抬起。已对偏置轮1122作了描述,但应当理解,偏置构件或偏置轮1122的形状为示例性的,可有各种变化以适应各种不同的形状,使用摩擦或牵引来接合或不接合端部执行器12的击发。
外科器械10的各种实施例具有在使用过程中一次或多次记录器械状况的能力。图44为用于记录器械10的状态的系统2000的框图。不难理解,系统2000可用在具有电动或电机助力击发的器械10的实施例中,例如上面参照图1-40所描述,并且可用在具有机械驱动击发的器械10的实施例中,例如上面参照图41-43所描述。
系统2000可包括用于感测器械状况的各种传感器2002、2004、2006、2008、2010、2012。这些传感器可设置在例如器械10的外面上或其内部。在各种实施例中,这些传感器可是只为系统2000提供输出的专用传感器,或可使用在器械10内执行其他功能的双用途传感器。例如,上述的传感器110、130、142可被构造成也向系统2000提供输出。
各个传感器直接地或间接地向存储装置2001提供信号,存储装置2001可记录下面详述的信号。存储装置2001可为能够存储或记录传感器信号的任何种类的装置。例如,存储装置2001可包括微处理器、电可擦除可编程只读存储器(EEPROM)或任何其他合适的存储装置。存储装置2001可记录由传感器以任何合适的方式提供的信号。例如在一个实施例中,存储装置2001可在信号改变状态时记录来自特定存储器的该信号。在另一个实施例中,存储装置2001可记录系统2000的状态,例如,在来自任一传感器的信号改变状态时记录来自系统2000的全部传感器的信号。这可提供关于器械10的状态的快照。在各种实施例中,存储装置2001和/或传感器可实现为包括可得自达拉斯半导体(DALLAS SEMICONDUCTOR)的1-WIRE总线产品,例如1-WIRE EEPROM。
在各种实施例中,存储装置2001是可从外部存取的,允许外部设备如计算机访问由存储装置2001记录的器械状况。例如,存储装置2001可包括数据端口2020。数据端口2020可根据任何有线或无线通信协议以(例如)串行或并行格式提供所存储的器械状况。存储装置2001还可包括除了输出端口2020以外的或取代输出端口2020的可移动存储介质2021。可移动存储介质2021可为能够可从器械10取下的任何种类的合适的数据存储装置。例如,可移动存储介质2021可包括任何合适种类的闪速存储器,例如个人计算机存储卡国际协会(PCMCIA)卡、COMPACTFLASH卡、MULTIMEDIA卡、FLASHMEDIA卡等。可移动存储介质2021还可包括任何合适的盘式存储器,例如移动硬盘、光盘(CD)、数字视频盘(DVD),等。
闭合扳机传感器2002可感测闭合扳机18的状态。图45和图46示出了闭合扳机传感器2002的示例性实施例。在图45和图46中,闭合扳机传感器2002设置在闭合扳机18和关闭枢轴销252之间。不难理解,将闭合扳机18扣向手枪式握把26可使闭合扳机18加力于关闭枢轴销252。例如,传感器2002可感测到该力并随之产生信号,如以上关于传感器110并参照图10A和图10B的描述。在各种实施例中,闭合扳机传感器2002可为仅指示闭合扳机18是否被驱动的数字传感器。在其他各实施例中,闭合扳机传感器2002可为指示作用于闭合扳机18的力和/或闭合扳机18的位置的模拟传感器。如果闭合扳机传感器2002为模拟传感器,则可在传感器2002和存储装置2001之间(在逻辑意义上)设置模数转换器。也不难理解,闭合扳机传感器2002可具有任何适当的形式,并可设于使闭合扳机的状况能够被感测的任何合适位置。
砧板关闭传感器2004可感测到砧板24是否被关闭。图47示出一种示例性的砧板关闭传感器2004。如图所示,传感器2004设于钉槽22的肾形开口1006内或其附近。在砧板24关闭时,砧板枢轴销25滑过肾脏形开口1006而接触到传感器2004,导致传感器2004产生指示砧板24已被关闭的信号。传感器2004可为任何合适的数字或模拟传感器,包括接近传感器等。不难理解,如果砧板关闭传感器2004为模拟传感器,则可在传感器2004和存储装置2001之间(在逻辑意义上)设置模数转换器。
砧板关闭载荷传感器2006如图所示设于钉槽22的内侧底部表面。使用时,传感器2006可能会接触钉仓34(图46中未示出)的底部侧。砧板24关闭时,在钉仓34上施加作用力,该作用力被传至传感器2006。作为响应,传感器2006产生一个信号。该信号可是与钉仓34因砧板24关闭而作用于传感器2006的力成比例的模拟信号。参照图44,该模拟信号可提供给模数转换器2014,其将该模拟信号转换成数字信号,然后提供给存储装置2001。不难理解,其中传感器2006为数字或二进制传感器的实施例可不包括模数转换器2014。
击发扳机传感器110可感测击发扳机20的位置和/或状态。在电动或电机助力的器械实施例中,击发扳机传感器可兼作以上描述的运行电机传感器110。此外,击发扳机传感器110可为上述的任何形式,并且可为模拟或数字的。图45和图46示出了击发扳机传感器110的另一实施例。在图45和图46中,击发扳机传感器装在击发扳机20和击发扳机枢轴销96之间。击发扳机20被扣动时,会对击发扳机枢轴销96施加力,该力为传感器110所感测。参照图44,在击发扳机传感器110为模拟输出的实施例中,包括设于击发扳机传感器110和存储装置2001之间(在逻辑意义上)的模数转换器2016。
割刀位置传感器2008感测割刀32或切割面1027在钉槽22中的位置。图47和图48示出割刀位置传感器2008的实施例,这两个实施例适于同图41所示的机械致动轴8和端部执行器12一起使用。传感器2008包括连接到器械10的击发杆1022上的磁铁2009。线圈2011环绕击发杆1022设置,并可例如沿着击发槽构件1012的纵向凹缝1014安装(见图41)。割刀32和切割面1027在钉槽22中往复通过,击发杆1022和磁铁2009会在线圈2011中来回穿过。这种相对线圈的运动感应出电压,该电压与击发杆在线圈内的位置以及切割面1027在钉槽22内的位置成比例。该电压可提供给存储装置2001,例如经由模数转换器2018提供。
在各种实施例中,作为替代,割刀位置传感器2008可用设于轴8上或内不同位置的一系列数字传感器(未示出)来实现。数字传感器可感测到击发杆1022的特征物例如磁铁2009,在该特征物通过轴8往复运动时被感测。击发杆1022在轴8内的位置,甚至于割刀32在钉槽22内的位置,可被近似为被脱开的最后一个数字传感器的位置。
不难理解,在具有旋转驱动端部执行器12和轴8的器械10的实施例中也可感测到割刀位置,例如以上参照图3-6所描述的情况。如编码器268的编码器可构造成能够产生与螺杆轴36(或任何其他传动轴或齿轮)的转动成比例的信号。因为轴36和其他传动轴和齿轮的转动与通过槽22的割刀32的移动成比例,由编码器268产生的信号也与割刀32的移动成比例。因此,编码器268的输出可被提供给存储装置2001。
钉仓存在传感器2010可感测到钉槽22内钉仓34的存在。在电动或电机助力的器械中,钉仓存在传感器2010可兼作钉仓闭锁传感器136,如以上参照图11所描述的情况。图50和图51示出了钉仓存在传感器2010的实施例。在所示的实施例中,钉仓存在传感器2010包括两个触点2011和2013。没有钉仓34时,触点2011、2013形成开路。当钉仓34存在时,钉仓34的钉仓托盘1028触碰到触点2011、2013而形成闭合电路。当电路开路时,传感器2010可输出逻辑0。当电路闭合时,传感器2010可输出逻辑1。传感器2010的输出被提供给存储装置2001,如图44所示。
钉仓状况传感器2012可指示装于钉槽22内的钉仓34是否已被击发即被耗用。由于割刀32穿过端部执行器12移动,其推动滑块33,而滑块击发钉仓。然后,割刀32移回其原始位置,将滑块33留在钉仓的远端。没有滑块33来引导,割刀32会落入闭锁袋2022中。传感器2012可感测到闭锁袋2022中是否有割刀32,这间接地表明钉仓34是否已被耗用。不难理解,在各种实施例中,传感器2012可能直接感测到滑块34在钉仓近端的存在,从而消除了对割刀32落入闭锁袋2022的需要。
图52A和图52B为外科器械10的操作实施例的流程2200,外科器械10构造为内切割器,并具有根据各种实施例记录器械状况的能力。在框2202处,器械10的砧板24可被关闭。这导致闭合扳机传感器2002和/或砧板关闭传感器2006改变状态。作为响应,在框2203处,器械2001可记录系统2000中的所有传感器的状态。在框2204处,器械10可被插入患者体内。当器械被插入时,砧板24可在框2206处被打开和关闭,例如在手术部位处理组织。砧板24的每次打开和关闭,导致闭合扳机传感器2002和/或砧板关闭传感器2004改变状态。作为响应,存储装置2001在框2205处记录系统2000的状态。
在框2208处,组织被夹紧以进行切割和缝合。如果在判定块2210处砧板24未关闭,则需要继续夹紧。如果砧板24是关闭的,则传感器2002、2004和/或2006年可改变状态,在框2213处促使存储装置2001记录系统的状态。这个记录可包括从传感器2006接收的关闭压力。在框2212处,可进行切割和缝合。在击发扳机20向手枪式握把26扣动时,击发扳机传感器110可改变状态。此外,当割刀32穿过钉仓槽22时,割刀位置传感器2008会改变状态。作为响应,在框2213处,存储装置2001可记录系统2000的状态。
当切割缝合操作完成,割刀32刀可返回到击发前位置。由于钉仓34现在已被击发,割刀32可能落入闭锁袋2022,改变钉仓状况传感器2012的状态,并在框2215处引发存储装置2001记录系统2000的状态。然后,可打开砧板24以清理组织。这可能会导致一个或多个闭合扳机传感器2002、砧板关闭传感器2004和砧板关闭负载传感器2006改变状态,导致在框2217处记录系统2000的状态。组织被清理后,可在框2220处再次关闭砧板24。对于至少传感器2002年和2004这将导致另一状态改变,继而又导致存储装置2001在框2219处记录系统的状态。然后,在框2222处,器械10可从患者体内取出。
如果在同一过程中再次使用器械10,砧板可在框2224处打开,并在框2223处引发另一次系统状态记录。用过的钉仓34可在框2226处从端部执行器12移走。这将导致钉仓存在传感器2010改变状态,并导致在框2225处记录系统状态。另一钉仓34可在框2228处插入。这会导致钉仓存在传感器2010的状态改变,并在框2227处进行系统状态的记录。如果另一个钉仓34是新钉仓,则在判定块2230处指明,其插入也会导致钉仓状况传感器2012的状态改变。在这种情况下,系统状态可在框2231处被记录。
图53示出根据各种实施例的存储装置2001的存储映射表2300。存储映射表2300包括一连串的列2302、2304、2306、2308、2310、2312、2314、2316和行(未标示)。列2302示出每一行的事件编号。其他列代表系统2000的一个传感器的输出。在给定时间记录的全部传感器读数,可在相同的事件编号下记录在同一行中。因此,每一行代表一个实例,其中记录一个或多个来自2000系统的传感器的信号。
列2304给出在各个事件上记录的关闭载荷。这可反映出砧板关闭载荷传感器2006的输出。列2306给出击发行程位置。这可源自割刀位置传感器2008。例如,割刀32的总行程可被分为几个分区。列2306中的数字可代表割刀32当前所在的分区。列2308中给出击发载荷。这可源自击发扳机传感器110。列2310给出割刀位置。与击发行程类似,割刀位置可源自割刀位置传感器2008。列2312中可示出砧板24是打开还是关闭。该值可源自砧板关闭传感器2004和/或砧板关闭载荷传感器2006的输出。列2314可示出滑块33是否存在或者钉仓34是否用完。这个值可源自钉仓状况传感器2012。最后,列2316可示出钉仓34是否存在。这个值可源于钉仓存在传感器2010。不难理解,各种其他值可存储在存储装置2001中,包括(例如)击发行程的结束和开始,例如由传感器130、142所测。
图54示出外科器械300的各种实施例。外科器械300可类似于上面描述的外科器械10,但其还包括与之可脱开地连接的状态模块302。虽然在图54中状态模块302被示为连接在柄部6的外部下侧构件60上,但是,状态模块302显然也可在任何合适的位置连接至外科器械300。根据各种实施例,外科器械300的柄部6具有一个被构造和配置成可接纳状态模块302的凹进部。
外科器械300包括多个传感器304(如图55示意性所示),其中多个传感器304包括(例如)关节角度传感器、砧板位置传感器、钉仓传感器、闭合扳机传感器、关闭力传感器、击发力传感器、割刀位置传感器、锁闭状况传感器,或它们的任意组合。每个传感器304可与接近外科器械300外部而设的不同的触点306(如图55示意性所示)电气连通。
传感器304可按任何适当的方式实施。例如,关节角度传感器可被实施为(例如)电位器,该电位器包括关节控制器16的一部分,并输出可指示端部执行器12的相对关节角度的信号。砧板位置传感器可能被实施为(例如)上述的砧板关闭传感器2004;钉仓传感器可被实施为(例如)上述的钉仓存在传感器2010;闭合扳机传感器可被实施为(例如)闭合扳机传感器2002;关闭力传感器可被实施为(例如)上述的砧板关闭载荷传感器2006;击发力传感器可被实施为(例如)上述的击发扳机传感器110;割刀位置传感器可被实施为(例如)上述的割刀位置传感器2008;闭锁状况传感器可被实施为(例如)上述的钉仓闭锁传感器136或钉仓存在传感器2010。多种外科器械的实施例公开于名称为“SURGICAL INSTRUMENTHAVING RECORDING CAPABILITIES(具有记录能力的外科器械)”、序列号为11/343,803的美国专利申请中,其全部公开内容以引证方式并入本申请。
根据各种实施例,状态模块302包括壳体308,其被构造和配置成可脱开地连接于外科器械300。状态模块308包括多个触点310(如图55示意性所示),其中,各个触点310被构造和配置成在壳体308连接于外科器械300时可与外科器械300的另一传感器304电气连通。例如,当状态模块302连接到外科器械300时,状态模块302的每一个触点310可与外科器械300的各个对应触点306对齐,从而将模块302的每个触点310设置成与另一传感器304电气连通。
状态模块302还包括与触点310以及多个指示器314(如图55示意性所示)中的至少一个连通的电路312(如图55示意性所示)。指示器314中的至少一个与电路312电气连通。电路312包括驱动电路,被构造和配置成驱动至少一个指示器314中。根据各种实施例,电路312还可包括(如图55示意性所示)开关316、计数器318、发射器320或它们的任何组合。
开关316与指示器314中的至少一个电气连通,并可被用来关闭与之电气连通的相应的指示器314。根据各种实施例,开关316可包括除电路312以外的状态模块302的一部分,或包括除状态模块302以外的手术器械300的一部分。对于这类实施例,开关316可与电路312电气连通。
计数器318可用来确定击发数、剩余的击发数、夹紧后等待时间等。根据多种实施例,计数器318可包括除电路312以外的状态模块302的一部分。根据另一些实施例,计数器318可包括除状态模块302以外的外科器械300的一部分。对于这类实施例,计数器318可与电路312电气连通。
发射器320可将由多个传感器304感测到的信息无线发送到与监视器(未示出)关联的无线接收器(未示出),所述监视器可供外科器械300的使用者在进行手术时观看。信息可通过无线方式连续或定期地传输。显示的信息可包括(例如)击发进展信息、加压载荷信息、割刀载荷信息、击发数、手术时间、加压等待时间、电池电量等。根据其他各种实施例,发射器320可包括除电路312以外的状态模块302的一部分,或包括除模块302以外的外科器械300的一部分。对于这类实施例,发射器320可与电路312电气连通。
图56-58示出状态模块302的各种实施例。如图所示,状态模块302可包括不同类型的指示器314。根据各种实施例,指示器314可包括一个或多个视觉指示器,例如发光二极管、多色发光二极管、显示器等,或它们的任何组合。显示器可包括(例如)字母数字显示器、点阵显示器、液晶显示器等。根据各种实施例,指示器314中的至少一个可包括听觉指示器,例如音频输出装置。音频输出装置可被实施为(例如)扬声器,并可与开关316电气连通。根据各种实施例,指示器314可包括至少一个视觉指示器和至少一个听觉指示器。
在操作中,指示器314可向外科器械300的使用者提供视觉和听觉反馈。例如,如图56所示,指示器314(例如发光二极管)可用来指示闭合扳机18是否在锁设置置,预定的夹紧后等待期间是否已经结束,钉仓34是否已装载等等。不同的指示器314可发出不同颜色的光。如图56和57中所用,不同的阴影线表示不同的颜色。指示器314(例如多色发光二极管)可用于外科器械300某个特定功能的多种状态指示。例如,为了指示钉仓34的状态,如果装载的钉仓34在槽22中,则多色发光二极管可发绿光;如果用过的钉仓34在槽22中,则可发黄光;或者如果钉仓34不在槽22中,则可发红光。同样地,为了指示外科器械300所施加切割力的状态,如果所施加的切割力在正常范围内,则多色发光二极管可发绿光;如果被施加的切削力在升高的范围,则可发黄光;或者如果被施加的切削力在高负荷范围内,则可发红光。应当知道,指示器314可用于外科器械300其他功能的多状态指示,例如电池电量的指示。
如图56所示,一行指示器314(例如发光二极管)可用来指示割刀32的前进、所施加的最大关闭力的百分比、所施加的最大击发力的百分比、端部执行器12的当前关节角度等。这些指示可给外科器械300的使用者提供关于涉及手术器械300的操作的力的反馈以及关于外科器械300已如何接近其最大能力的反馈。虽然图56中仅示出一行指示器314,但应当知道,状态模块302可包括任意行数的指示器314。
如图57所示,状态模块302可包括两圈布置成圆周走向的指示器314(例如发光二极管)。对于这类实施例,状态模块302能够向外科器械300的使用者提供比图56所示的302状态模块更多的并发信息。虽然图57中示出两圈圆周布置的指示器,但影单知道,状态模块302可包括布置成任意取向的任意数目的指示器314。例如,状态模块302可包括布置成金字塔图案的指示器314。
如图58所示,状态模块302的指示器314可包括一行发光二极管和至少一个显示器(例如液晶显示器)。这类实施例的状态模块302能够向外科器械300的使用者提供比图56或图57所示的状态模块302更多的并发信息。例如,发光二极管能够以条形图示出砧板24和钉仓22上的作用力、电池电量、关节角度等。显示器能够以数字形式显示关于关闭力、击发力、剩余击发数、夹紧后等待时间、行程进展、关节角度等。名称为“SURGICAL INSTRUMENT HAVING A FEEDBACK SYSTEM(具有反馈系统的外科器械)”、序列号为11/343,545的美国专利申请公开了各种外科器械,该专利申请的全部公开内容以引证方式并入本申请。
再者,在各种实施例中,外科器械如手术缝合器300可在外科器械使用前和/或使用后进行消毒。在至少一种消毒技术中,参照图60,外科器械可被放置在封闭的密封容器如容器301中,其中,例如在某些实施例中,该容器可由塑料如高密度聚乙烯纤维或(例如)TYVEK构成,并可具有任何合适的外壳的形状。容器和器械然后可放置在能够穿透容器的辐射场中。在各种情况下,辐射例如可包括伽玛辐射、X射线和/或高能电子,其中,辐射可杀死器械300上和容器301中的细菌。密封的无菌容器301可保持器械300无菌,直到在手术室或其他合适的环境中打开。然而,在某些情况下,当使用辐射如伽马射线辐射(举例来说)消毒器械300时,外科器械300的部件,特别是例如诸如存储器和/或处理器之类的电子元件,会因受辐射而损坏,并且可能成为有缺陷或不稳定。至少一种这样的存储装置可能包括如上所述的存储装置2001,当存储装置2001暴露于辐射中,至少存储映射表2300内所载的某些数据可能会丢失和/或损坏。在某些情况下,辐射消毒处理甚至可能损害所谓“辐射加固”的电子产品。鉴于上述情况,一些可替代的消毒处理,如环氧乙烷、过氧化氢和/或蒸汽消毒处理可用来消毒整个器械300。然而,在某些情况下,这种替代消毒处理可能不会如辐射消毒处理那样优选,至少对于消毒外科器械的端部执行器是如此(举例而言)。
在各种实施例中,外科器械可包括可操作地彼此接合和/或脱开的第一部分和第二部分。进一步地,在至少一个实施例中,第一部分可包括手术缝合器的柄部和端部执行器,如手术缝合器300的柄部6和端部执行器12,第二部分可包括可选择的附加部分,如状态模块302,其中第一部分和第二部分可分别消毒。因此,在某些实施例中,例如手术缝合器的柄部和端部执行器可用辐射消毒处理进行消毒,而可包括电子元件和/或任何其他辐射敏感元件可选择的性附加部分可用任何其他合适的消毒处理消毒,如蒸汽和/或环氧乙烷消毒处理。在至少一个这样的实施例中(下面作更详细的描述),在第一部分和第二部分已被单独消毒后,第一部分和第二部分可被组装在一起和/或可操作地彼此接合。
在各种实施例中,参照图59,外科器械可包括外科器械400和可选择的附加模块402。在某些实施例中,外科器械400可包括空腔404,其可被构造成接纳模块402的至少一部分。在至少一个实施例中,模块402可包括一个或多个端子或触点403,其可被构造成与外科器械400的一个或多个端子或触点(未图示)接合,以将模块402设置成与外科器械400通信。更具体地,外科器械400和模块402的端子或触点可被设置成可互相通信,因此例如电能、模拟信号和/或数字信号可在外科器械400和模块402之间传输。在模块402组装到外科器械400上之前,模块402可被消毒并随后置于无菌容器内。在某些实施例中,模块402可在已放入容器内时进行消毒。进一步地,在这两种情况下,外科器械400都可在(例如)已通过伽马辐射处理之后从无菌容器如容器301取出,以使模块402可与外科器械400可操作地接合。在至少一个实施例中,模块402可在使用中从其无菌容器或袋401取出,然后可插入空腔404,使得触点或端子403与外科器械400的触点或端子连通。
进一步地,在各种实施例中,外科器械的第一部分如外科器械400的柄部6和端部执行器12可从无菌容器取出,其中外科器械的第二部分如模块402的至少相当一部分可留在其无菌容器内。在至少一个实施例中,例如袋401可被扎破或切开,使得模块402的端子403可至少部分地伸出袋401并使得端子403可与外科器械400的端子接合。在某些实施例中,端子403可被造构成扎破或切开袋401。在至少一个这样的实施例中,终端403可被构造成在用足够的力将其对着袋401推压时将袋401扎穿。在一些实施例中,袋401可包括例如被削弱部分或划痕,其可被构造成让袋401沿着预定路径撕开。在某些实施例中,端子403可包括阳端子而外科器械400可包括阴端子,其中阳端子可插入阴端子,以在它们之间形成电气接触。在各种实施例中,虽然没有图示,例如,可选择的附加模块可包括一个或多个阴端子而外科器械可包括一个或多个可被构造成扎穿袋401的阳端子,以与模块的阴端子接合。
上述情况的结果是,在任何情况下,第一部分如端部执行器12的柄部6和外科器械400和第二部分如模块402,可进行不同的消毒处理,并可例如装入分别消毒的容器内提交给手术室。因此,含有辐射敏感元件的第二部分可经受合适的非辐射消毒处理,而第一部分可经受辐射消毒处理,而不损坏外科器械。然而,在某些情况下,这种非辐射消毒处理可能不能完全或适当地将外科器械的第二部分消毒。在这种情况下,细菌或其他污染物(举例来说)会存在于提交到手术室的容器或袋401内(举例来说)。然而,在各种实施例中,例如,袋401和模块402可被构造成为在将端子向袋401按压端子403时只有很小部分的袋401被扎穿或切开。在至少一个这样的实施例中,袋401内所含的细菌或其他污染物可能会在袋被打开后还留在袋401内,且可能无法从袋401内逸散。
进一步地,在某些实施例中,存放外科器械的第二部分的容器能够被构造成与外科器械的第一部分配合,使得该容器和第一部分可限制或防止细菌和/或容器内的污染物的迁移(如果容器内存在的话)迁移到患者的手术部位。再参照图59,在至少一个实施例中,袋401和模块402构成为这样:当它们被插入外科器械400的空腔404时,袋401能够密封地(或至少基本上密封地)与空腔404的侧壁接合。因此,在至少一个这样的实施例中,细菌和/或污染物可被阻止(或至少被抑制)从袋401之内迁移到外科器械400的外部。在各种实施例中,模块402和袋401可在端子403刺穿袋401之前被插入空腔404,因此,在端子403与外科器械400的端子接触(或至少差不多接触)前,袋401内尚未有孔形成。在至少一个这样的实施例中,穿刺部位可加以保护,以不让密封袋401内的细菌或污染物与外科器械400的任何患者接触区域连通。在某些实施例中,例如,袋401和模块402可被构造成使得它们能够在空腔403内形成紧贴配合或压配合。虽然未图示,在至少在一些实施例中,模块402可包括可被构造成接合于和/或被接合于外科器械400的一个或多个连接构件或连接部。例如在至少一个实施例中,连接构件能够被构造成将袋401刺穿,而在其他实施例中,连接构件可被构造成与外科器械400接合而不刺穿袋401。
在各种实施例中,外科器械的第一部分可被送到手术室,例如在第一密封容器内,而外科器械的第二部分可置于第二密封容器中传送,其中在与第一部分一起使用时,第二部分可保持密封于容器内。在至少一个实施例中,第一部分可例如包括手术缝合器的柄部和端部执行器,并且第二部分可包括可被构造成与第一部分无线通信的模块。在至少一个这样的实施例中,模块可包含在一个密封袋中,例如袋401中,其中模块和密封袋可插入手术缝合器的空腔如空腔404内。在各种实施例中,模块可包括无线信号发射器和/或接收器,另外,手术器械也可包括无线信号发射器和/或接收器,以使模块和手术缝合器可通过无线传输或信号通信。因此,在至少一个这样的实施例中,包含模块的袋或封套可无需穿孔或切开以让模块执行其一项或多项预定功能,不论这些功能是例如显示信息、记录来自手术缝合器的信息,以及/或者是将信息传递给手术缝合器。在至少一个这样的实施例中,模块可包括可被构造成向模块提供足够电源以执行其预定功能的电源。在某些实施例中,电源可与模块包含在第二密封容器内。在任何情况下,让模块的无线发射器和/或接收器工作可能仅需很少电能,因为在使用过程中模块和手术缝合器很靠近,尤其在模块被至少部分地置于手术缝合器内时。
在某些其他实施例中,外科器械的第二部分或模块可不连接至或设置在手术缝合器的第一部分内。在至少一个这样的实施例中,模块可保留在其密封容器内,可例如放在手术室内任何合适的地方,以使该模块可与外科器械的第一部分直接通信。因此,在这类实施例中,在无辐射的情况下消毒的模块可设置得离患者比上述其他实施例更远,从而进一步降低细菌或其他污染物迁移至患者的可能性。在至少一个实施例中,模块和容器可被设置在对接底座上或对接底座内。在某些实施例中,对接底座可包括无线发射器和/或接收器,以使模块和/或外科器械可与对接底座无线通信,并使对接底座可将数据或信息在模块和手术缝合器之间转发。与上述类似,在至少一个实施例中,第二部分或模块可包括一个或多个端子或触点如端子403(举例来说),其可被构造成穿透存放模块的容器如袋401(举例来说),以可操作地接合于对接底座的端子或触点。在至少一个这样的实施例中,模块可直接接合于对接底座,其中对接底座可包括无线发射器和/或接收器,其可被构造成与外科器械的第一部分无线通信。有多种外科器械公开于名称为“POST-STERILIZATION PROGRAMMING OF SURGICALINSTRUMENTS(外科器械的后杀菌程序设计)”、序列号为11/651,771的美国专利申请,其全部公开内容以引证方式并入本申请。
在某些实施例中,外科器械可包括可通过第一伽马辐射消毒处理进行消毒的第一部分和可通过第二伽马辐射消毒处理进行消毒的第二部分。在至少一个实施例中,与(例如)第一伽马辐射消毒处理中的伽马辐射的强度和/或持续时间相比,第二伽马辐射消毒处理可具有(例如)较低强度和/或较短持续时间的伽马辐射。在至少一个这样的实施例中,第二部分可包括电子元件,如存储装置或处理器和/或任何其他辐射敏感元件,它们可安全通过较低强度和/或较短持续时间的辐射。因此,在各种实施例中,第一部分可在第一密封无菌封套内消毒,第二部分可在第二密封无菌封套内单独地或分开地进行消毒。在这类实施例中,伽玛辐射可既用来消毒第一部分又用来消毒第二部分,尽管二者可能是不同等级的消毒。在任何情况下,外科器械的第一部分和第二部分可被送到例如手术室,并可组装在一起、可操作地接合在一起和/或以其他适当的方式相互配置。
在某些实施例中,外科器械可包括两个以上的可独立消毒的部分。在至少一个实施例中,外科器械可包括:可通过第一消毒处理进行消毒并置入第一密封无菌容器送到(例如)手术室的第一部分;可通过第二消毒处理进行消毒并置入第二密封无菌容器送到手术室的第二部分;以及可通过第三消毒处理进行消毒并置入第三密封无菌容器送到手术室的第三部分。在至少一个这样的实施例中,第一部分可包括外科器械的端部执行器,如外科器械300的端部执行器12,第二部分可包括柄部如柄部6,第三部分可包括可选择的附加模块如模块402。进一步地,在某些实施例中,第一部分可通过伽马辐射消毒处理(举例来说)进行消毒,第二部分可通过与第一辐射消毒处理相比具有较低强度和/或较短持续时间的伽玛辐射消毒处理(举例来说)消毒,第三部分可通过非辐射消毒处理(举例来说)进行消毒。在任何情况下,当相对于外科装置的其他部分组装、可操作地接合和/或以其他适当方式配置时,这些部分中的一个或多个可保持密封在其封套内和/或仅部分地从其封套取出。
在某些情况下,期望将半杀菌或未杀菌的电源、其他部件和/或其他电子元件与外科器械可操作地接合和/或脱开,以便在外科手术期间使用。在一个实施例中,电源、其他部件和/或其他电子元件能够至少部分地、可移除地设置于外科器械中限定的腔体内。在多种实施例中,电源和/或电子元件可是例如未杀菌的,可使部分杀菌的,和/或可包括未杀菌或部分杀菌的部分,而外科器械可利用例如杀菌过程(例如伽马辐射杀菌过程)进行完全杀菌。外科器械在密封容器(例如上述容器301)内可是完全无菌的。该杀菌过程可与上述杀菌过程相同。本申请中,术语“无菌”或“无菌的”可指通过杀菌过程而处理到足以在外科手术期间暴露使用的水平(即,对手术室和/或患者暴露)。术语“未杀菌的”、“半杀菌的”、“非无菌”和/或“部分杀菌的”可指不通过杀菌过程进行处理、部分地通过杀菌过程进行处理和/或通过杀菌过程进行处理但是不到足以在外科手术期间暴露使用的水平。
在大多数情况下,应当防止非无菌电源和/或其他电子元件或其各部分在外科手术期间暴露于患者或手术室,以便至少最小化外科手术期间由例如电源和/或其他电子元件上的各种细菌、污染物和/或微生物引起的手术室和/或患者的污染。在各种实施例中,例如,电源可被构造为向外科器械供电,电子元件可被构造为控制和/或操作外科器械。在其他各种实施例中,电子元件可被构造为记录由外科器械执行的各种任务或操作。在一个实施例中,电子元件可包括一个或多个电子元件。在其他各种实施例中,电子元件可是任选的,并且可提供一个或多个电源。
在各种实施例中,外科器械系统可被构造为允许例如外科器械的非无菌或半无菌部分(例如电源或各种电子元件)至少部分地插入到外科器械的无菌部分中并且与该无菌部分一起使用。在某些实施例中,电源和/或电子元件可通过第一杀菌处理而被处理到第一杀菌程度,并且无菌部分可通过第二杀菌处理而被处理到较大的第二杀菌程度,使得第二部分无菌。在某些情况下,第一和第二杀菌处理可包括相同、类似或不同的杀菌方法。
在一个实施例中,参见图61和62,外科器械系统可包括外科器械500,该外科器械包括第一部分502和第二部分504。外科器械500可包括与上述外科器械300和400类似的部件,但还可包括闭合构件506,该闭合构件506在或连接到第二部分504上。在各种实施例中,闭合构件506可被构造为在第一位置和第二位置之间运动,以覆盖在外科器械500的第二部分504中限定的腔体508或接纳狭槽。在使用之前,第二部分504例如可包装在密封容器(例如容器301),并且如上所述地进行杀菌。在一个实施例中,第二部分504可包括具有壁512的外科器械主体510,该壁512中限定腔体508。第一部分502可包括电源(例如电池)和/或一个或多个电子元件(例如控制器芯片)。第一部分502可通过膜514进行包封,或者可封闭在密封包装(也为514)内。在一个实施例中,膜或密封包装514可包括微生物不可渗透的阻挡层。尽管没有示出,但是第一部分502可包括容纳在第一膜中的电源和容纳在第二膜中的各种电子元件。例如,封闭电源的第一膜和封闭各种电子元件的第二膜都可设置在腔体508中,或者可每个分别设置在外科器械主体510内限定的单独的腔体中。通过提供上述外科器械系统,非无菌或半无菌的第一部分502在外科手术期间可选择性地与无菌的第二部分504一起使用,而不会污染手术室、第二部分504的暴露与患者的表面和/或患者。在其他各种实施例中,第一部分502可是无菌的,并可仍然放置到用于额外预防的膜514中。
在一个实施例中,参见图61-63,第一部分502可包括电源503,例如电供应器或电能源,例如向负载供应电能的装置或系统。在各种实施例中,电源503可是电池,该电池包括单个电化学原电池或多个电化学原电池的组合,以存储化学能。多个电化学原电池可组合,以提供比单个电池高的电压或高的电流。在一个实施例中,电池可包括不可充电的一次电池。不可充电的电池包括碱性电池和碱性电池单元(alkaline cells),除了别的以外,其可采用锌和锰(IV)氧化物(Zn/MnO2)、锌-碳、锌-氯化物和银-氧化物之间的反应。碱性电池可包括氢氧化钾碱性电解质。在一个实施例中,电池可包括可充电的二次电池。可充电的电池可使用电气可逆的电化学反应,可具有多种不同的尺寸,使用化学物质的不同组合。常使用的二次电池(“可充电电池”)的化学物质为铅酸、镍镉(NiCd)、镍金属氢化物(NiMH)、锂离子(Li-离子)和锂离子聚合物(Li-离子聚合物)。在其他实施例中,电源503可是直流(DC)电源、联接到频率为50或60Hz的主电源或其他通用电源的交流(AC)电源、开关式电源。以举例的方式,根据输入和输出的波形,开关式电源可分为四个类型:(1)AC入,DC出:整流器,离线转换器输入阶段;(2)DC入,DC出:电压转换器,或电流转换器,或DC到DC转换器;(3)AC入,AC出:频率改变器,环转换器,变压器;或者(4)DC入,AC出:逆变器。在其他实施例中,第一部分502可包括状态模块,例如上述的状态模块302。
进一步地,在其他各种实施例中,第一部分502可包括其他可选的电子元件(例如微处理器),该电子元件能够控制外科器械500和/或向外科器械500提供指令。在各种实施例中,这样的电子元件可包括或者可实施为:计算机系统、计算机子系统、计算机、微处理器、控制器、微控制器、例如专用集成电路(ASIC)的集成电路、可编程逻辑装置(PLD)、例如通用处理器的处理器、数字信号处理器(DSP)、接口、输入/输出(I/O)装置、开关、电路、逻辑门、寄存器、半导体装置、芯片、晶体管、或任何其他装置、机器、工具、设备、部件或它们的组合。在一个实施例中,根据预定的计算机语言、方式或语法,可选的电子元件可通过软件、软件模块、应用、程序、子程序、指令组、计算代码、语音、符号或它们的组合来进行控制,以用于指示处理器执行某个功能。计算机语言的实例可包括C、C++、Java、BASIC、Perl、Matlab、Pascal、VisualBASIC、汇编语言、机器代码、用于网络的微代码等。在其他各种实施例中,第一部分502可包括其他可选的电子元件(例如存储器装置),该电子元件能够记录外科器械500的各种信息和/或操作。在一个实施例中,例如这样的电子元件可与电源503接合,设置在电源503上或靠近电源503,和/或设置在电源503的壳体上或设置在电源503的壳体内。
进一步地,在各种实施例中,第一部分502可包括一个或多个电气端子或触头518,其可被构造为电气地接合第二部分504上的一个或多个电气端子或触头520。端子或触头520可设置在腔体508内或设置成靠近腔体508,使得它们能够在第一部分502设置在腔体508中时与端子518接合。在一个实施例中,端子520可被设置在相对于外科器械主体510的外表面的腔体508的最深部分之一中,使得由端子518或520引起的膜514的任何刺穿都靠近腔体508的最深部分之一。当与第二部分504的腔体508接合时,第一部分502可被放置成与第二部分504连通,使得能够例如在第一部分502和第二部分504之间传递电能、模拟和/或数字信号。在某些实施例中,第一部分502上的端子518可包括阳端子,并且第二部分504上的端子520可包括阴端子,其中阳端子518可与阴端子520接合和/或插入到阴端子520,以便在它们之间形成电接触。第一部分502的阳端子518均可包括刺穿末端522,该刺穿末端能够例如当以足够的力压靠膜514时刺穿、刺破或切割膜514,以便与第二部分504的阴端子520接合。由刺穿末端522在膜514中产生的孔可仅仅稍大于端子518的外周边,以至少抑制来自膜514内的污染物、细菌或微生物从膜514移出。在某些情况下,膜514中的孔的侧壁可例如与端子518的外部部分形成密封或密封表面,以再次至少抑制来自膜514内的污染物、细菌或微生物从膜514移出。在各种实施例中(尽管没有示出),例如,第一部分502可包括一个或多个阴端子,并且第二部分504可包括一个或多个阳端子。在这样的实施例中,当第一部分502以足够的力被推向第二部分504上的端子时,第二部分504上的阳端子可刺穿膜514并且接合第一部分502上的阴端子。
在其他各种实施例中,膜514可例如包括削弱部分、穿孔部分和/或划痕,其可被构造为允许膜514沿着预定路径撕开或分开。在一个实施例中,膜514位于端子518和端子520中间的整个部分可被穿孔和/或可包括划痕,使得当端子518或第一部分502的一区域以足够的力被推靠膜514时,膜514的一部分能够与膜514的其余部分分离,并且暴露包括端子518的第一部分502或部分地暴露包括端子518的第一部分502。通常,当第一部分502设置于腔体508内且当腔体508至少部分地与外部无菌环境被密封开时可能出现这种情况。
在各种实施例中,在端子518刺穿膜514之前,第一部分502可完全地或部分地插入到腔体508中,使得端子518不会在膜514中形成孔,直到端子518与第二部分504的端子520接触或者至少几乎接触,并且闭合构件506至少大部分处于第一位置,从而将腔体508与第二部分504的无菌外表面密封。当端子518和520彼此接合时,它们自身可形成防止污染物、细菌和/或微生物从膜514内迁移的阻挡物,原因是它们的接合基本上可在第二部分504的一部分和第一部分502的一部分之间形成压密封,从而将膜514的一部分夹在它们之间。在这样的实施例中,膜514可用作密封件。因此,可保护膜514的刺穿部位,使得膜514内的细菌、微生物和/或污染物不能与第二部分504的任何患者暴露区域或表面连通。
在某些实施例中(尽管没有示出),第二部分504可包括一个或多个附连构件或部分,其可被构造为接合第一部分502,和/或被第一部分502接合。在一个实施例中,附连构件可被构造为例如刺穿膜514,而在其他实施例中,附连构件可被构造为接合第一部分502而不刺穿膜514。在本发明的范围内,第一部分502和第二部分504之间还可采用任何其他合适的接合形式。
在各种实施例中,参见图61-63,外科器械500的第二部分504可包括轴524,该轴具有近侧端部526和远侧端部528。例如,外科器械主体510可从近侧端部526延伸,并且可包括扳机部分530,该扳机部分包括第一扳机和第二扳机。扳机部分530可与从轴524的远侧端部528延伸的端部执行器532可操作地接合,使得其能够用来驱动端部执行器532。在其他实施例中,驱动按钮或构件(未示出)可用来取代扳机部分530。在这样的实施例中,例如,端部执行器532可包括至少一个电极,该电极能够密封组织。在某些其他实施例中,端部执行器532可包括任何合适的端部执行器,该端部执行器能够例如执行组织密封功能、组织缝合功能、组织切割功能、组织连接功能和/或任何其他合适的外科功能。在一个实施例中,例如,端部执行器532能够连接到例如轴524的远侧端部528或者与该远侧端部528一起形成。
在各种实施例中,仍然参见图61-63,腔体508可被限定在第二部分504的外科器械主体510中。在某些实施例中,壁512可限定外科器械主体510中的腔体508的边界。腔体508可限定能够用于接纳第一部分502的任何合适的形状。在一个实施例中,腔体508可包括第一区域和第二区域,该第一区域包括一个或多个电气端子520,该第二区域包括外科器械主体510中与腔体508连通的开口或通道。第二部分504中的腔体508可被构造为至少部分地或完全地接纳第一部分502,而第一部分502被膜或密封包装514包封和/或包围。可选的密封件或密封表面(未示出)可形成为邻近、靠近、围绕或部分地围绕腔体508的第二区域的开口或通道。例如,这样的密封件或密封表面可与闭合构件506的一部分接合,或者与闭合构件506上的密封件或密封表面接合,以形成微生物不可渗透的或至少部分地微生物不可渗透的密封件,例如当膜514可选地被端子518刺穿时,该密封件可至少抑制第一部分502上或膜514内的细菌、微生物和/或污染物移出腔体508。
在某些实施例中,再次参见图61-63,闭合构件506可靠近腔体508的第二区域的开口而连接到、接合到或者可枢转地或可旋转地连接到第二部分504。在一个实施例中,闭合构件506能够在第一位置与第二位置之间移动、滑动、旋转和/或枢转,在该第一位置,闭合构件506与腔体508的第二区域可密封地接合或者可密封地接触,在该第二位置,闭合构件506至少部分地没有与腔体508的第二区域可密封地接合或者可密封地接触,或者没有与腔体508的第二区域可密封地接合或者可密封地接触。在一个实施例中,第一位置可是关闭位置,其中腔体508至少部分地或完全地与外科器械主体510的外表面密封,第二位置可是打开位置,其中腔体508不是完全与外科器械主体510的外表面密封。当处于第一位置时,闭合构件506例如可接触腔体508的第二区域的密封件或密封表面。
进一步地,在各种实施例中,闭合构件506可包括顶部表面536、底部表面538和可选的密封件或密封表面(未示出)。可选的密封件或密封表面可设置成靠近底部表面538的周边和/或设置成靠近、围绕或至少部分地围绕闭合构件506的能够接合腔体508的第二区域的外周边。密封件或密封表面可以被构造为当与第二区域或者腔体508的第二区域上的密封件或密封表面接合时在腔体508和外科器械主体504的无菌外表面之间形成微生物不可渗透的阻挡物或至少抗微生物阻挡物。这样的阻挡物可以至少抑制第二部分504的外表面被半无菌或非无菌的第一部分502微生物污染。
在各种实施例中,当第一部分502至少部分地设置于腔体508内时,闭合构件506的底部表面538可以接触第一部分502并且在闭合构件506从第二位置移入到第一位置时迫使第一部分502更加深入到腔体508中。在一个实施例中,参见图63的示例性图示,底部表面538可以包括从该底部表面突出的可选的凸轮表面540。凸轮表面540可以由弹性材料和/或不可挠曲的材料构成。在某些实施例中,闭合构件506可以包括弹簧,例如悬臂弹簧和/或片簧,该弹簧可以作用在凸轮表面540上并且偏压该凸轮表面540。在一个实施例中,凸轮表面540可以被构造为与第一部分502接合,并且在闭合构件506从第二位置移入到第一位置时迫使第一部分502更加深入或更进一步到腔体508中。凸轮表面540和/或底部表面538可以将力传递到第一部分502,这在闭合构件506至少部分地或完全地移动到第一位置时能够使得第一部分502上的一个或多个端子518(阳)刺穿膜514并且接合第二部分504上的一个或多个端子520(阴)。在其他各种实施例中,凸轮表面540或底部表面538可以将力传递到第一部分502,这在闭合构件506至少部分地或完全地移动到第一位置时能够使得第二部分504上的一个或多个端子(阳)刺穿膜514并且接合第一部分502上的一个或多个端子(阴)。在这样的一个实例中,端子518和520可以在接合时彼此电气连通。在各种实施例中,闭合构件506可以在第一和第二位置之间手动和/或自动地移动、滑动、旋转和/或枢转。在闭合构件506枢转或旋转的实施例中,闭合构件506可以例如包括铰链521或连接到铰链521。在各种实施例中,闭合构件506和/或第二部分504可以包括任何合适的闩锁系统523,以将闭合构件506保持在第一位置中。闩锁系统523还可以用来帮助将第一部分502密封在腔体508内。
通过在闭合构件506从第二位置移动到第一位置时利用端子518的刺穿末端522来提供膜514的刺穿,任何可能出现在第一部分502上和/或膜514内的污染物、细菌和/或微生物由于闭合构件506而能够被限制在腔体508内。换言之,当第一部分502由于闭合构件506以及腔体508的第二区域上的可选的密封件或密封表面和/或闭合构件506的可选的密封件或密封表面而至少部分地和可能完全地封闭和密封在腔体508内时,膜514可以被刺穿末端522刺穿。因此,半无菌或非无菌的第一部分502可以与无菌的第二部分504一起使用,而不会污染外科手术部位、第二部分504的无菌外表面和/或患者。
在各种实施例中,当第一部分502在包封和/或密封在膜514内的情况下至少部分地设置在腔体508中时,膜514和腔体508的壁512例如由于第一部分502在腔体508内的紧密贴合而能够彼此可密封地接合。这一特征可帮助在端子518的刺穿末端522刺穿膜514之后抑制任何污染物、细菌和/或微生物从腔体508中逸出。另外,膜514的刺穿可发生在腔体508的最深部分之一处。因此,任何离开膜514的污染物不仅能够保持在密封的腔体508内,而且还能够由于膜514和腔体508的壁512之间的可密封接合而保持在腔体508的深部处。换言之,膜514和壁512之间的可密封接合可以增加保护污染物不从腔体508逸出的额外的层。
在某些其他实施例中,闭合构件506可以包括推动螺钉(未示出),该推动螺钉螺纹穿过一穿透闭合构件506的孔。在这样的实施例中,闭合构件506可以在腔体508的第二区域上方移动到第一关闭位置,以将腔体508与外部环境和/或第二部分504至少大部分或完全密封。然后,推动螺钉的驱动器或手柄可被旋转或者以其他方式驱动,以推动螺钉的端部远离手柄,从而接合第一部分502并且将第一部分502推得更深或更进一步地推到腔体508中。在这样的一个实例中,闭合构件506中的孔和/或推动螺钉的接触该孔的侧壁或螺纹的部分可以带有密封件、密封表面或密封材料,以至少抑制腔体508内的细菌、微生物和/或污染物通过该孔离开腔体508而污染无菌的第二部分504的表面。在这样的实施例中,当闭合构件506处于完全关闭位置以将任何污染物保持在腔体508内时可以刺穿膜514。
在各种实施例中,当闭合构件506在打开位置和关闭位置之间运动时,闭合构件506可以在各个阶段作用在第一部分502上。在第一阶段中,闭合构件506可以与第一部分502接合。在第二阶段中,闭合构件506可以随着闭合构件506朝向关闭位置运动而开始将第一部分502推入腔体508。在第三阶段中,闭合构件506例如可以使端子518(阳)接合端子520(阴)。在该第三阶段期间,围绕腔体508的第二区域的开口或通道的密封件和/或靠近闭合构件506的外周边的密封件可以接合,以开始将腔体508与外科器械500的外部密封。在第四阶段中,闭合构件506可以随着闭合构件506运动到完全关闭位置而使得端子518刺穿膜514并且设置成与端子520电气连通。在该刺穿期间,如本申请所述,随着闭合构件506运动到完全关闭位置而可以压缩一个或多个合适设置的密封件,从而形成合适的密封。
在其他各种实施例中,第一部分502可以不包括从第一部分502延伸的具有刺穿末端的端子,并且可以分别以无线的方式或通过感应而与第二部分504通信和/或向第二部分504供电。因此,在某些实施例中,膜514可以完全不需要被刺穿,从而将任何微生物、污染物和/或细菌保持在膜514内。在第一部分502通过感应与第二部分504通信的实施例中,第一部分502可以设置在腔体508内,并且第一部分502上的触头可以设置成靠近第二部分504上的触头,使得电力能够在它们之间传递。在第一部分502通过无线方式向第二部分504传递电信号的其他实施例中,第一部分502例如可以设置在手术室内任何合适的位置处或者靠近手术室的位置。在这样的实施例中,第一部分502和第二部分504均可包括无线发射器和无线接收器,以在它们之间实现这样的无线通信。因此,非无菌或半无菌的第一部分502可以设置成与无菌的第二部分504和/或患者相距一段距离,从而进一步减少第一部分502上的和/或膜514内的污染物、细菌和/或微生物污染外科手术部位、第二部分504的外表面和/或患者的机会。与以上所述类似,第一部分502还可以例如设置在对接底座处。在某些实施例中,当第一部分502与第二部分504无线通信时,可以例如去除腔体508。
在各种实施例中,膜514可以由气体可渗透、微生物不可渗透的材料或阻挡层构成,使得第一部分502上的任何细菌、微生物和/或污染物可以被保持在膜514内。在某些实施例中,膜514可以例如由气体不可渗透、微生物不可渗透的材料构成。合适的膜材料可以包括聚乙烯材料,例如涂有抗微生物材料的TYVEK材料。抗微生物涂层可以包括例如酯、脂质和/或银离子,从而得到具有抗微生物特性的聚乙烯材料。在一个实施例中,例如碳氟化合物试剂(例如FC-808、氟代-脂族酯)可以用作抗微生物涂层。
在某些情况下,第一部分502可在已经受杀菌处理(例如蒸汽、环氧乙烷、臭氧和/或过氧化氢杀菌处理)之后设置在膜514内。在其他情况下中,第一部分502可经受杀菌处理,同时密封在膜514内或者被膜514包封。在任何情况下,第一部分502可设置在膜514内,然后膜514可以利用任何合适的密封方法进行密封,例如热密封。这样,第一部分502上的任何细菌、微生物和/或污染物可以包含在膜514内,并且不可能暴露给手术室、第二部分504的外表面和/或患者。
在操作中,外科器械系统可以允许非无菌或半无菌的第一部分502与无菌的第二部分504接合,而不会污染第二部分504的外表面。这样,第二部分504可以用在手术室中并且可以暴露给患者,同时包含非无菌或半无菌的第一部分502。在一个实施例中,第一部分502可在外科手术区(即无菌环境,有时候是手术室)外部设置并密封在膜514内。于是,第一部分502在密封在膜514内的同时可以被带入外科手术区。第二部分504也可在无菌容器(例如容器301)中被带入外科手术区。接下来,可从无菌容器中移除第二部分504,然后第一部分502在仍然处于膜514内的同时设置在第二部分504的外科器械主体510中限定的腔体508内。在某些情况下,第一部分502可以紧密地配合在腔体508内和/或压配合在腔体508内,其中膜514能够可密封地接合腔体508的壁512,以在膜514和壁512之间形成密封或可密封的接合。然后,闭合构件506可以从至少部分地打开的第二位置移动到第一关闭位置。随着闭合构件506从第二位置移动到第一位置,例如,闭合构件506的底部表面538或可选的凸轮表面540可作用于第一部分502,以将第一部分502进一步推入腔体508并且使得端子518或520刺穿膜514且在第一部分502和第二部分504之间形成电气连接。然后,外科医生可将外科器械系统用于外科手术,同时第一部分502被限制在第二部分504的腔体508内。
在外科手术之后,可从外科手术部位移除外科器械系统,闭合构件506可从第一位置移动到第二位置,并且可从第二部分504移除第一部分502。然后,可从剩下的膜514移除第一部分504,并且可丢弃剩下的膜514。在各种实施例中,第一部分502可选地进行修复、杀菌或部分地杀菌,然后设置在新的膜514内,并且准备用于另一个无菌的第二部分504。在其他各种实施例中,第一部分502可设置在新的膜514内而完全不进行处理或杀菌。因此,第一部分502(尽管通常非无菌)可在多个外科手术中重复使用,而不需要在之前或之后进行杀菌或者至少杀菌到无菌的第二部分504的水平。
在各种实施例中,可能期望的是提供电子元件,例如电源、控制器芯片、编程芯片、微控制器、微处理器、状态模块和/或其他各种电子元件,这些电子元件涂有抗菌或抗微生物材料或者提供于包含抗菌或抗微生物材料的壳体中。这样,这些各种电子元件可不需要利用常规杀菌技术(例如伽马辐射杀菌技术)进行杀菌。在各种实施例中,例如,壳体和涂层的材料可实际上防止、杀死或至少抑制细菌或微生物的污染。例如,因为这些电子元件通常能够连接到或接合到无菌外科器械或其各部分以控制外科器械和/或向外科器械供电,所以可能理想的是它们不会污染无菌外科器械。在一个实施例中,例如,壳体内的或涂有抗菌或抗微生物材料的电子元件可如上所述设置在膜514内。
在一个实施例中,一个或多个电子元件可设置或包封在由抗菌或抗微生物材料(例如银或抗微生物的脂质)构成的壳体内。在其他实施例中,壳体可包括由抗菌或抗微生物材料构成的外表面。在某些其他实施例中,电子元件可涂有抗菌涂层或抗微生物涂层。在任何情况下,在被设置在壳体内之前或者在被涂覆之前,电子元件可浸泡在抗微生物的皂溶液中和/或其他抗微生物的溶液中,以减少电子元件上出现的污染物、细菌和/或微生物的量。在各种实施例中,从电子元件延伸的或设置在电子元件上的一个或多个电气触头或端子可由导电性抗菌材料或导电性抗微生物材料构成和/或可涂有导电性抗菌材料或导电性抗微生物材料。银可是这种导电性材料的一个实例。
在壳体围绕电子元件的实施例中,一个或多个通风口可设置在壳体中,以允许在电子元件的工作期间冷却电子元件。通风口可涂有气体可渗透且微生物不可渗透的材料,例如类似于TYVEK的聚乙烯材料,以允许气体(例如空气)流入和流出壳体并且冷却电子元件,但是防止或至少抑制电子元件上的或壳体内的任何微生物、细菌和/或污染物离开壳体。在一个实施例中,覆盖通风口的材料可包括抗微生物涂层。这些抗微生物涂层可包括酯、脂质和/或银离子,从而提供具有抗微生物特性的覆盖通风口的材料。在一个实施例中,例如碳氟化合物试剂(例如FC-808、氟代-脂族酯)可用作抗微生物涂层。在某些实施例中,壳体或电子元件本身可包括翅片或散热器,该翅片或散热器能够从电子元件消散热。这些翅片或散热器可由导热的抗菌或抗微生物的材料构成或涂覆有导热的抗菌或抗微生物材料。
在各种实施例中,一个或多个电子元件(例如控制器芯片)可连接到另一个电子元件(例如电源)。在一个实施例中,电子元件可连接到电源、和电源一起形成、和电源一起设置在壳体内和/或以其他方式与电源结合。在各种实施例中,可不设置电源,并且仅仅电子元件可设置在壳体内和/或涂有抗菌或抗微生物材料。图64和65示出了示例性电子元件,例如电源。本领域的技术人员将会理解,本发明并不限于此。
在一个实施例中,参见图64-66,一个或多个电子元件600(例如电源、用于可编程控制器的芯片和/或可编程控制器)上可具有抗菌涂层或抗微生物涂层601(例如见图64)和/或可被壳体602包围,该壳体602包括由抗菌或抗微生物材料构成或部分地构成的外表面604(例如见图65和66)。在各种实施例中,一些示例性的抗菌或抗微生物材料可包括嵌有银离子的塑料、具有抵抗或杀死细菌的纳米结构的塑料或金属(例如鲨鱼皮和纳米碳管)和/或包括有氧化钛微槽的材料,该氧化钛微槽能够具有从电源流过该氧化钛微槽的流动电流(trickling electrical current)。例如,鲨鱼皮可防止或至少抑制细菌、微生物和/或其他污染物附接到其表面。其他纳米结构材料可向匕首一样刺破不期望的细胞(即细菌、微生物和/或其他污染物),以杀死细胞和/或破坏细胞的病毒物质。在一个实施例中,通过使用来自电源的流动电荷,外壳体602可被稍稍通电或充电,以杀死其上出现的细菌、微生物和/或其他污染物。一些抗菌或抗微生物涂层可包括例如碘、抗生素(例如青霉素)、抗微生物的脂质和/或银离子涂层。当然,本领域的技术人员将会认识到,任何其他合适的抗菌或抗微生物材料或涂层可用来包括壳体602的一部分或者可用作电子元件600或壳体602上的涂层。
在各种实施例中,再次参考图64和65,电子元件600可包括一个或多个电气触头或端子606。一个或多个电气端子606可与外科器械的一个或多个电气触头或端子(未示出)接合,使得电子元件600能够通过例如数字信号、模拟信号和/或电信号与外科器械通信。电气端子606可涂有抗菌或抗微生物材料或者可由抗菌或抗微生物材料形成,使得电气端子606至少部分地抵抗微生物或细菌的污染。如果电气端子606从壳体602延伸,则密封件(未示出)可设置在电气端子606延伸穿过壳体602的位置处,以至少抑制来自电子元件600的微生物、细菌和/或污染物离开壳体602。电气端子606的抗菌或抗微生物材料通常可是导电性的或至少具有导电部分,使得电气端子606能够导电或传导电信号。在各种实施例中,电气端子606可具有刺穿末端622,与上述刺穿末端522类似,其可被构造为例如刺穿与上述膜514类似的膜或密封包装。
在各种实施例中,散热装置或结构可例如设置在壳体602上、连接到壳体602、与壳体602形成为一体、与电子元件600一起形成、连接到电子元件600和/或与电子元件600和/或壳体602热接触。在一个示例性实施例中,参见图64,翅片或散热器610示出为从电子元件600延伸。翅片或散热器610可由高导热抗菌材料或抗微生物材料(例如银)构成和/或可涂有抗菌材料或抗微生物材料。在其他实施例中,翅片或散热器610可由例如铝和/或不锈钢构成,其中铝和/或不锈钢可涂有抗菌材料或抗微生物材料,例如银。在翅片或散热器610涂覆有涂层的实施例中,翅片或散热器610可由高导热材料构成,以帮助从电子元件600散热。抗菌材料、抗微生物材料、抗微生物的涂层和抗微生物涂层例如可与上述相同。在一个实施例中,翅片或散热器610可包括与壳体602的抗菌材料、抗微生物材料、抗菌涂层和抗微生物涂层不同的抗菌材料、抗微生物材料、抗菌涂层和抗微生物涂层。例如,散热器或翅片610可由热传递特性比电子元件600上的涂层或壳体602的材料好的材料构成。
在各种实施例中,参见图65,壳体602中可限定有一个或多个通风口(例如通风口612)。通风口612可允许气体(例如空气)流入和流出壳体602,使得壳体602内的一个或多个电子元件600在电子元件600的工作或激活期间能够被冷却。在一个实施例中,通风口612可涂有微生物不可渗透、气体可渗透的阻挡层614,该阻挡层能够允许气体穿过,但是能够防止或至少抑制来自壳体602内的微生物穿过通风口612。通风口612可附加地或代替上述翅片或散热器610用在壳体602上。在各种实施例中,图66示出了沿图65的线66-66截取的横截面图。在这样的实施例中,示出壳体602为包围两个电子元件,每个标记为600,例如为电源和控制器芯片。因此,其示出了电子元件600上出现的任何污染物、细菌和/或微生物如何由于壳体602的密封特性而能够被限制在壳体602内。
虽然已经通过描述几个实施例显示了本发明,虽然已经相当详细地描述了示例性实施例,但是申请人的意图不在于将权利要求的范围约束或以任何方式限制到这些细节中。额外的优点和修改形式对于本领域的技术人员而言可是明显的。此外,虽然已经结合外科器械描述了本申请中公开的实施例,但是可设想出与任何适当的医疗装置有关的其他实施例。尽管已经将本发明作为示例性设计进行了描述,但还可在本公开的精神和范围内对本发明进行修改。因此本发明旨在涵盖采用本发明一般原理的任何变型型式、用途或适应型式。此外,本发明旨在涵盖本发明之外但在本发明所属领域的已知或惯有实践范围内的偏差型式。
再者,已经结合外科切割器械描述了本发明的各种实施例。然而,应该指出,在其他实施例中,本申请中公开的经消毒的外科器械无需是外科切割器械。例如,所述器械可是内窥镜式非切割器械、抓握器、缝合器、施夹器、进入装置、药物/基因治疗给药装置、利用超声波、射频、激光等的能源装置等。在某些实施例中,超声器械可根据本发明公开的实施例进行消毒并加以利用。在至少一个这样的实施例中,超声器械可包括具有柄部和/或端部执行器(举例来说)的第一部分以及包括具有对辐射敏感的电子产品的第二部分,第二部分可与第一部分分开进行单独消毒。2000年5月16日公告的名称为“ARTICULATABLE ULTRASONIC SURGICALAPPARATUS(铰接超声外科设备)”的美国专利号6,063,098公开了各种超声器械,其全部公开内容以引证方式并入本申请。虽然本申请中结合某些公开的实施例对本发明作了描述,但是这些实施例的许多修改和变化形式也可被实现。例如,可采用不同类型的端部执行器。另外,凡是公开了用于某些元件的材料的,均可使用其它材料。上述具体实施方式和下述权利要求旨在涵盖所有这样的修改和变型形式。
除以上所述,本发明所公开的各种钉仓可为一次性的。在至少一个实施例中,消耗的钉仓或至少部分消耗的钉仓能够从手术缝合器中取出并用另一钉仓替换。在其他各种实施例中,钉仓不能够在外科器械的正常使用过程中移除和/或更换,但是在一些情况下,能够在重新调整手术缝合器(如下面详述)的同时和/或之后进行更换。在各种实施例中,钉仓可为一次性加载装置或端部执行器的一部分,该加载装置或端部执行器还可包括钉仓载体、砧板、切割构件和/或缝钉驱动件。在至少一个这样的实施例中,一次性加载装置或端部执行器的全部或至少一部分能够被可拆卸地连接至外科器械并能够被构造成可更换。
本发明公开的装置可被设计为在一次使用之后丢弃,或它们可被设计为多次使用。然而无论是哪种情况,该器械都可在至少使用一次后经过修复再行使用。修复的步骤可包括拆卸装置、清洗或更换具体部件以及后续重新组装步骤的任何组合。特别是,该装置可拆卸,并且可任意组合选择性地置换或移除任意数目的某些部分或零件。清洗和/或更换特定部件后,可在修理厂或在紧临外科手术前由外科小组人员将器械重新装配,以供后续使用。本领域的技术人员将会知道,修复装置的步骤可利用用于拆卸、清洁/更换和再组装的多种技术。这样的技术的使用以及所得修复装置都在本公开的范围内。
以引证方式全部或部分地并入本申请的任何专利、公布或其它公开材料都仅在所并入的材料不与本发明所述的现有定义、陈述或其它公开材料相冲突的范围内并入本申请。同样地并且在必要的程度下,本申请明确阐述的公开内容取代了以引证方式并入本申请的任何冲突材料。
Claims (12)
1.一种外科器械,包括:
第一部分,所述第一部分包括至少一个第一电气触头;
膜,所述膜包封所述第一部分;以及
第二部分,所述第二部分包括:
外科器械主体;
壁,所述壁限定所述外科器械主体中的腔体,其中所述腔体能够至少部分地接纳所述第一部分,同时所述第一部分保持被所述膜包封;
第一区域,所述第一区域包括至少一个第二电气触头;
第二区域,所述第二区域包括与所述腔体连通的开口;以及
闭合构件,所述闭合构件能够在第一位置和第二位置之间运动,
其中所述闭合构件在处于所述第一位置时与所述第二区域可密封地接合,其中所述闭合构件在处于所述第二位置时至少部分地没有与所述第二区域可密封地接合,并且其中所述第一电气触头和所述第二电气触头中的一个能够在所述闭合构件从所述第二位置运动到所述第一位置中时刺穿所述膜,以便在所述第一部分和所述第二部分之间进行电气连接。
2.根据权利要求1所述的外科器械,其中所述第一部分包括非无菌部分,并且其中所述第二部分包括无菌部分。
3.根据权利要求1所述的外科器械,其中所述闭合构件能够枢转地连接到所述第二部分,并且其中所述闭合构件能够在所述第一位置和所述第二位置之间枢转。
4.根据权利要求1所述的外科器械,其中所述闭合构件包括:
外周边;
密封件,所述密封件设置成围绕所述外周边或靠近所述外周边,其中所述密封件能够当所述闭合构件处于所述第一位置时与所述第二区域接合,并且在所述腔体与所述第二部分的外表面之间形成微生物不可渗透的阻挡物,以至少抑制所述第二部分的所述外表面被所述第一部分微生物污染。
5.根据权利要求1所述的外科器械,其中所述第二部分包括密封件,所述密封件设置成围绕所述开口或者靠近所述开口。
6.根据权利要求1所述的外科器械,其中所述闭合构件包括:
凸轮表面,所述凸轮表面能够当所述闭合构件从所述第二位置运动到所述第一位置时将所述第一部分推入所述腔体中。
7.根据权利要求1所述的外科器械,其中所述第一部分包括电源。
8.根据权利要求1所述的外科器械,其中所述第一部分包括能够操作所述第二部分的电子元件。
9.根据权利要求1所述的外科器械,其中所述第二部分包括:
轴,所述轴具有近侧端部和远侧端部;
从所述近侧端部延伸的所述外科器械主体;以及
端部执行器,所述端部执行器从所述远侧端部延伸。
10.一种外科器械系统,包括:
第一部分,所述第一部分包括至少一个第一电气端子;
密封包装,其中所述第一部分设置在所述密封包装内,并且其中所述密封包装包括微生物不可渗透的阻挡层;以及
第二部分,所述第二部分包括:
外科器械主体;
接纳狭槽,所述接纳狭槽限定在所述外科器械主体中,其中所述接纳狭槽能够接纳所述第一部分的至少一部分,同时所述第一部分设置在所述密封包装内;
第一区域,所述第一区域包括至少一个第二电气端子;
第二区域,所述第二区域限定进入所述接纳狭槽的通道;
以及
闭合构件,所述闭合构件能够在第一位置和第二位置之间运动,
其中所述闭合构件在处于所述第一位置时与所述第二区域可密封地接触,其中所述闭合构件在处于所述第二位置时至少部分地没有与所述第二区域可密封地接触,并且其中所述闭合构件包括凸轮表面,所述凸轮表面能够迫使所述第一部分进入所述接纳狭槽并且能够在所述闭合构件从所述第二位置运动到所述第一位置时使得所述第一电气端子和所述第二电气端子中的一个刺穿所述密封包装,以便在所述第一部分和所述第二部分之间进行电气连接。
11.根据权利要求10所述的外科器械系统,其中所述第一部分包括非无菌部分,并且所述第二部分包括无菌部分。
12.根据权利要求10所述的外科器械系统,其中所述第一部分包括电源和电子元件中的至少一个,所述电源能够向所述第二部分供电,所述电子元件能够控制所述第二部分的操作。
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Patent Citations (2)
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US5341810A (en) * | 1991-10-29 | 1994-08-30 | Sulzer Medizinaltechnik Ag | Sterile puncturing device for blood vessels with a non-sterile ultrasound probe, and apparatus for preparing the device |
CN101224117A (zh) * | 2007-01-10 | 2008-07-23 | 伊西康内外科公司 | 外科器械的消毒后编程装置和方法 |
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AU2010322031B8 (en) | 2013-10-31 |
IN2012DN04849A (zh) | 2015-09-25 |
JP5795321B2 (ja) | 2015-10-14 |
US8414577B2 (en) | 2013-04-09 |
BR112012011999A2 (pt) | 2016-05-10 |
WO2011063038A3 (en) | 2011-07-14 |
CN102711630A (zh) | 2012-10-03 |
WO2011063038A8 (en) | 2012-05-31 |
EP2501298A2 (en) | 2012-09-26 |
CA2781272C (en) | 2018-02-27 |
RU2012125262A (ru) | 2013-12-27 |
AU2010322031A1 (en) | 2012-06-07 |
BR112012011999B1 (pt) | 2020-02-11 |
JP2013511342A (ja) | 2013-04-04 |
EP2501298B1 (en) | 2016-03-30 |
CA2781272A1 (en) | 2011-05-26 |
AU2010322031A8 (en) | 2013-10-31 |
US20100198220A1 (en) | 2010-08-05 |
PL2501298T3 (pl) | 2016-10-31 |
RU2554224C2 (ru) | 2015-06-27 |
WO2011063038A2 (en) | 2011-05-26 |
AU2010322031B2 (en) | 2013-10-24 |
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