CN100569189C - 带有电活化聚合物致动的拱托脱离机构的外科缝合器械 - Google Patents

带有电活化聚合物致动的拱托脱离机构的外科缝合器械 Download PDF

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CN100569189C
CN100569189C CNB2005100895309A CN200510089530A CN100569189C CN 100569189 C CN100569189 C CN 100569189C CN B2005100895309 A CNB2005100895309 A CN B2005100895309A CN 200510089530 A CN200510089530 A CN 200510089530A CN 100569189 C CN100569189 C CN 100569189C
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surgical instruments
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CN1726878A (zh
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弗雷德里克·E·谢尔顿四世
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Ethicon Endo Surgery Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B17/07207Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously the staples being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00017Electrical control of surgical instruments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • A61B2017/00871Material properties shape memory effect polymeric
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/29Forceps for use in minimally invasive surgery
    • A61B2017/2926Details of heads or jaws
    • A61B2017/2927Details of heads or jaws the angular position of the head being adjustable with respect to the shaft

Abstract

将用于内窥镜检查或腹腔镜检查的外科器械插入到外科手术部位以同时对组织进行缝合和切割,该器械包括对夹持在缝钉施加组件的上部和下部钳口的内表面上的拱托垫采用电致动脱离。因而,可对厚层或薄层进行缝合和切割,而且没有不适当的缝钉形成,也没有拱托垫未优化脱离。电活化聚合物(EAP)致动锁闩、EAP通道或带有EAP压紧锁定的刚性通道可靠地夹持所述拱托垫,直到需要以较小的力脱离以将与为脱离而激活的各EAP机构相结合的所述缝合和切割的拱托垫/组织分离。

Description

带有电活化聚合物致动的拱托脱离机构的外科缝合器械
互相参照的相关申请
本申请要求Shelton IV于2004年7月28日申请的、系列号为No.60/591,694的美国临时申请的权益,该申请的名称为“SURGICALINSTRUMENT INCORPORATING AN ELECTRICALLY ACTUATEDARTICULATION MECHANISM”。
技术领域
本发明通常涉及能够在切割缝合线之间的组织的同时在组织上施加多行缝钉的外科缝合器械,具体而言,本发明涉及对缝合器械的改进和对用于形成这样的缝合器械的各种零部件的方法的改进,所述器械包括在切割和缝合组织上添加夹圈材料。
背景技术
与传统的开放式外科设备相比,通常优选使用内窥镜和腹腔镜外科器械,因为其具有较小的切口,易于减少术后恢复时间和并发症。腹腔镜和内窥镜外科手术的使用已经相对普遍,并且这些使用提供了额外的鼓励以进一步发展该手术。在腹腔镜手术中,通过一小切口在腹内部进行外科手术。类似地,在内窥镜手术中,通过皮肤上的小进入创口将狭窄的内窥镜检查管插入到身体的任一中空腑脏中以进行外科手术。
腹腔镜和内窥镜手术一般要求将外科手术区域吹气。因而,任何一种插入到体内的器械必须是密封的,以确保气体不会通过切口进入体内或排出体外。此外,腹腔镜和内窥镜手术通常要求外科医生作用在远离所述切口的器官、组织和/或血管上。因此,用于此类手术的器械典型地较长而且窄,同时其能够从所述器械的近端进行功能上的控制。
适合于通过套管针的套管将远端执行器精确地放置在需要的手术部位的内窥镜外科器械领域已经有了显著的发展。这些远端执行器可通过多种方式与组织接合,以获得诊断或治疗效果(例如内切割刀、夹紧器、切割器、钉合器、夹具施放器、接触装置、药物/基因治疗输送装置以及使用超声波、RF、激光等的能量装置)。
已知的外科钉合器包括一端部执行器,其同时在组织中形成一个纵向切口,并在切口的相对两侧施加多行钉。端部执行器包括一对协同操作的钳口构件,如果该器械用于内窥镜或腹腔镜应用,则该对钳口能够通过套管通路。其中一个钳口构件容纳一个具有至少两排横向间隔地布置的钉的储缝钉匣。另一个钳口构件限定了一个砧板,该砧板具有与储缝钉匣中的钉排对齐的钉形成槽。该器械包括多个往复运动的楔形件,这些楔形件在被向远端驱动时通过储缝钉匣内的开口并与支撑该钉合器的驱动器接合,以使钉合器朝向砧板发射钉。
在以这种方式使用外科缝合器时的一个已知的问题在于,在缝合的肺组织中产生空气泄漏。该泄漏可在切线上和/或在其缝钉孔中产生。通常地,患病的肺组织薄而脆,并且随着肺的再次膨胀会在缝钉处撕裂。这些空气泄漏能保持持久,可使得患者的住院时间延长数星期。为了减轻这些泄漏问题,外科医生通过在所需的缝合部位施加拱托或填絮材料并通过拱托材料进行缝合来增强缝合线。所述拱托材料增强了易碎的组织。该组织被压在缝钉孔上,致使肺停滞(Pneumostasis)增加。这减少了组织在缝合线处撕裂的机会,并减少了在易碎组织中拔出缝钉的可能。
典型地,将这些增强材料可释放地安装在外科缝合设备的钳口部件上,从而在发射时,该增强材料被缝合于所述肺组织上。优选地,该肺组织是夹在两层这种增强材料之间的。另一可选的方案是,拱托材料可以用于大量的其它外科手术,例如但不局限于:卵巢子宫切除术、胃绕道术、肠组织吻合术或者任何其它在组织中需要增强缝合线或增强止血的手术。
可释放地将拱托材料连接于外科缝合设备的钳口构件上存在特有的挑战。该拱托材料必须可靠地固定在外科缝合设备的钳口上,从而不会在正常的操作中脱落,然而在发射缝钉之后,该材料必须容易从所述外科缝合设备上脱开。已经公知各种粘合剂和机械式附着装置。下面将讨论粘合剂和机械式附着装置,它们都有其不足之处。
在Gravener等人的美国专利No.5,441,193中披露了一个设备的例子,其用粘合剂将拱托材料附着于线性切割器上。所述设备用生物相容的腈基丙烯酸酯粘合剂将拱托材料附着于外科器械上。沿着拱托材料的边缘部分进行粘合剂粘接,并且在拱托材料内(邻近粘合线)设置穿孔的虚线,从而可以将拱托材料的未上胶的中心部分从胶合的边缘部分上撕开。然而,带有粘合剂的拱托材料部分不会从该设备上脱离。因而,由于必须同时撕去在穿孔之间的所有材料以便将外科缝合装置从组织上松脱,所以将拱托从所述器械上移除(发射以后)是特别困难的。一种对通过粘合剂接合的拱托材料的改进方案随后由Grant在美国专利No.6,656,193中公开,其包括具有可靠的粘合性的机械对准部件,并具有关于附着与分离的有益特征。
也已经公知将拱托材料的各种机械连接装置使用于外科缝合和切割器械。现有许多机械连接方法,一个常用的方法是在外科缝合设备的钳口构件上放置套管。该套管可由诸如拱托材料的柔性织物制成,或者可包含拱托材料的附着于不同织物上的可剥离条。多种这样的套管在以下专利中有记载:Cooper等人的美国专利No.5,503,638和5,549,628,Rayburn等人的美国专利No.5,702,409,Rayburn等人的美国专利No.5,810,855,和McKean等人的美国专利No.5,964,774。
尽管能够有效地使用套管将拱托材料连接于外科缝合设备的端部执行器上,在外科手术过程中套管会带来其它麻烦。例如,如果套管由拱托材料的固体套管形成,例如在美国专利No.5,902,312和No.5,796,892中那样,发射外科缝合设备会缝合拱托和组织并切割在缝钉和缝线之间的拱托套管和组织。这种动作留下与一片拱托材料连接的部分组织(在切割线的任一边)。这需要外科医生介入并切断拱托的套管以分开切割组织,并且移除拱托材料的任何不想要的部分。
也已经公知的是,结合易碎的特性,在使用坚固的保持以防止无意脱落以及在缝合之后使用不适当的过高力进行脱离之间要有一种折衷。例如,在McKean等人的美国专利No.5,542,594、No.5,908,427和No.5,596,774中,拱托材料被钉在端部执行器表面上。在Rayburn等人的美国专利No.5,702,409和5,810,855中,在每个钳口上装配多孔的聚四氟乙烯(PTFE)管,而且每个管具有一撕开的平坦表面。作为折衷,期望在缝合之前采用更高的保持力,而在缝合之后减小保持力度。
因此,非常需要有一种改进的外科缝合和切割器械,其可以将拱托材料可靠地定位在将要缝合和切割的组织的每一侧上,随后容易使该拱托材料脱离所述器械。
发明内容
本发明通过提供一种外科器械克服了上述和其它现有技术中的缺陷,该器械利用电致动保持构件可靠地使拱托材料接合紧固件施放组件的组织压缩表面。因此,结实的接合避免了无意的脱落,然而该电动保持构件可以转换到脱开状态,以在固定到组织上之后使拱托材料脱离,而无需后面的外科手术。
在本发明的一个方面中,用于将拱托材料固定在组织上的外科器械具有在远侧连接在细长轴上的缝钉施加组件,该细长轴响应发射构件的远侧运动,穿过第一和第二拱托垫,在相对的组织压缩表面之间形成介入压缩组织的缝钉。电致动保持构件有选择地放置在接合位置之间,将所选的拱托垫保持到所选的组织压缩表面上,由电路控制该电动保持构件以实现保留和脱离拱托垫中的一种。因而,对保持力的静态量的依靠被可选择大小的力所替代。
在本发明的另一个方面中,用于将拱托材料固定在组织上的外科器械结合了电活化聚合物的优点,该聚合物作为一种装置用于将拱托垫接合在一对组织压缩表面中的每一个上,并在拱托垫缝合介入的组织之后从远处电控制拱托垫的脱离。因而,所述外科器械的执行部分在用于通过内窥镜或腹腔镜手术过程所用套管针的插管插入的横截面上可以十分小。
(1)本发明提供一种用于将拱托材料固定在组织上的外科器械,其包括:细长轴;紧固件施放组件,其在远侧连接于细长轴,并包括相对的组织压缩表面;电致动保持构件,其有选择地放置在接合位置,将拱托材料保持在所选的组织压缩表面上;以及控制电路,其可操作地配置以产生控制信号,从而致动所述电致动保持构件,使所述拱托材料脱离。
(2)根据(1)所述的外科器械,其中,所述电致动保持构件进一步包括电活化聚合物。
(3)根据权利要求(1)所述的外科器械,其中,所述电致动保持构件进一步包括由电活化聚合物致动器移动的锁闩。
(4)根据权利要求(1)所述的外科器械,其中,所述电致动保持构件进一步包括被放置以接收拱托材料的侧边缘的保持支架和电致动器,该电致动器带有被放置以后选择地进入通道的移动端。
(5)根据权利要求(4)所述的外科器械,其中,所述电致动器的大小被可操作地设置为使所述保持支架向外变形,以释放拱托材料的被接收的侧边缘。
(6)根据权利要求(4)所述的外科器械,其中,所述保持构件包括覆盖在所述拱托材料的被接收的侧边缘上的覆盖的凸缘,所述电致动器放置在所述拱托材料的被接收的侧边缘的相对侧,以保证在所述拱托材料上的锁定力。
(7)根据权利要求(1)所述的外科器械,其中,所述电致动保持构件包括连接于所选定的组织压缩表面上的电活化聚合物致动器,该电活化聚合物致动器用于以最接近拱托材料的被接收的侧边缘的方式向外扩展所述电致动保持构件的基底部分,并弯曲所述电致动保持构件的在被接收的侧边缘与压缩表面相对的表面上方的锁闩部分,所述电活化聚合物致动器可操作地构造以由压缩的接合状态变化成膨胀的脱离状态。
(8)根据权利要求(7)所述的外科器械,其特征为,所述电活化聚合物致动器可操作地构造以响应电激励,使基底部分向上、向外膨胀。
(9)根据权利要求(1)所述的外科器械,其中,所述紧固件施放组件包括含有缝钉匣的下部钳口和可枢转地连接的上部钳口。
(10)根据权利要求(9)所述的外科器械,其中,所述电致动保持构件包括覆盖且连接于所述上部钳口的顶面的弯曲的弹性构件,该弹性构件具有相对于所述上部钳口向内弯曲的端部,该弯曲的端部被定位以保持拱托材料的侧边缘,该拱托材料位于上部钳口的上部组织压缩表面上,所述电致动保持构件进一步包括一对电活化聚合物致动器,其在所述弯曲弹性构件和所述上部钳口之间。
(11)根据权利要求(1)所述的外科器械,其中,所述紧固件施放组件包括圆形缝钉施加组件。
(12)根据权利要求(1)所述的外科器械,进一步包括手柄部分,其可操作地构造以便由细长轴引导的发射构件向远侧前进到所述紧固件施放组件,所述控制电路可操作地构造以感应并响应所述发射部件的发射前进,从而致动电致动保持构件。
(13)根据权利要求(1)所述的外科器械,其中,所述紧固件施放组件进一步包括夹子施放组件。
(14)根据权利要求(1)所述的外科器械,其中,所述紧固件施放组件进一步包括锚固件施放组件。
(15)根据权利要求(1)所述的外科器械,其中,所述紧固件施放组件进一步包括缝合器施放组件。
(16)本发明提供一种用于将拱托材料固定在组织上的外科器械,其包括:细长轴,它包括引导发射部件的框架基底,用于进行往复的轴向运动;手柄部分,其在近侧连接于所述细长轴上,并可操作地构造以纵向移动所述发射部件;第一和第二拱托垫;缝钉施放组件,其在远侧连接于所述细长轴上,并包括相对的组织压缩表面,该表面可操作地构造以响应所述发射部件的远侧运动,穿过第一和第二拱托垫以及介入的压缩组织,在相对的组织压缩表面之间进行缝合;电致动保持构件,它可选择地放置在接合位置之间,夹持所选的拱托垫到所选的组织压缩表面上;以及控制电路,可操作地配置以产生控制信号,致动所述电致动保持构件来实现保留第一及第二拱托垫和使其脱离中的一种。
(17)根据权利要求(16)所述的外科器械,其中,所述缝钉施加组件包括含有缝钉匣的下部钳口,该缝钉匣限定了一个组织压缩表面,还包括一个可枢转地连接的上部钳口,其限定了另一个组织压缩表面。
(18)根据权利要求(16)所述的外科器械,其中,所述缝钉施加组件包括一个圆形的缝钉施加组件。
(19)根据权利要求(16)所述的外科器械,其中,所述电致动保持构件进一步包括电活化聚合物。
(20)本发明提供一种用于将拱托材料固定在组织上的外科器械,其包括:细长轴;缝钉施加组件,其在远侧连接于细长轴上,并包括相对的组织压缩表面;以及如下所述装置,即,该装置将拱托垫接合在每个组织压缩表面上,并在缝合介入的组织之后通过电活化聚合物的致动从远处电动控制所述拱托垫的脱离。
结合附图以及此处的说明书,可以对本发明的这些以及其它目的和优点显而易见。
附图说明
组成本说明书一部分的附图示出了本发明的实施例,并且和上述的本发明综述以及下面给出的对实施例的详细描述一起用于说明本发明的原理。
图1示出了处于打开位置的外科缝合和切割器械的局部切去的侧视图,其带有电致动的拱托脱离机构,图中下部拱托垫从下部钳口分离,且细长轴被局部切去。
图2示出了图1所示外科钉合切割器械的缝钉施加组件的左侧正视图。
图3示出了从图2所示缝钉施加组件的下部钳口移除的可替换缝钉匣的左前侧透视图。
图4为图3所示可替换缝钉匣的左前侧透视分解图。
图5为沿图2中的线5-5的截面获得的下部钳口的右侧正视图,其中下部的侧向电活化聚合物(EAP)拱托锁闩处于锁定状态。
图6为沿图2中的线5-5的横截面获得的下部钳口的右边正视图,其中下部的侧面EAP拱托锁闩处于解锁状态。
图7为处于解锁状态的后部EAP拱托锁闩的左侧详图。
图8为图2所示缝钉施加组件的上部钳口(砧板)的左侧透视图。
图9为图2所示缝钉施加组件的上部钳口(砧板)的左侧透视分解图。
图10为图2所示缝钉施加组件的上部钳口(砧板)在通过线10-10的横截面上获得的主视图,其中上部的侧面EAP锁闩与拱托垫接合。
图11为图2所示缝钉施加组件的上部钳口(砧板)在通过线10-10的横截面上获得的主视图,其中上部侧面EAP锁闩被致动且省略了脱开的拱托垫。
图12为用于图1所示外科缝合和切割器械的可替换缝钉施加组件的侧正视图,其中下部前边EAP锁闩接合下部拱托垫。
图13为从图12所示的可替换缝钉施加组件的下部钳口移出的可替换缝钉匣的左前侧透视图。
图14为图12所示下部钳口的左侧详图,其中下部前边EAP锁闩被致动以从一个图中省略的拱托垫脱开。
图15为图12所示下部钳口的左侧透视分解图,该下部钳口带有开有狭槽的拱托垫。
图16为带有EAP锁闩通道的一种替代的可替换缝钉匣的正面透视图,其用于图2所示的缝钉施加组件的下部钳口。
图17为图16所示一种替代的可替换缝钉匣在通过线17-17的横截面上获得的前侧透视图,其通过与拱托垫接合的去致动(收缩)EAP锁闩通道。
图18为图16所示替代的可替换缝钉匣在沿线17-17的横截面上获得的前侧透视图,其通过激励(膨胀)的EAP锁闩通道,该通道与一个在图中省略的拱托垫分开。
图19为用于图2所示缝钉施加组件的附加的替代下部钳口的右侧的前侧透视图,该图在通过一刚性拱托通道的横向截面上获得,所述通道带有锁定拱托垫的处于未激活的膨胀位置的EAP夹紧锁定。
图20为用于图2中缝钉施加组件的图19所示附加的替代下部钳口的右侧的前侧透视图,该图在通过一刚性拱托通道的横向截面上获得,所述通道带有处于激活的收缩位置的EAP夹紧锁定,所述EAP夹紧锁定与已脱离并在图中省略的拱托垫脱开。
图21为带有EAP拱托锁闩机构的圆形外科缝合器的透视图。
具体实施方式
参看附图,其中在所述的几幅图中相同的附图标记代表相同的部件,在图1-2中,外科缝合和切割器械10包括手柄部分12,它可操纵以定位由固定的端部执行器、特别是缝钉施加组件16形成的执行部分14,其远侧连接到细长轴18上。执行部分14的尺寸被设置为在内窥镜和腹腔镜的外科手术过程中可通过套管针的插管(未示出)插入。有利的是,电致动拱托脱离机构20可靠性地将上、下拱托垫22、24分别保持在上部钳口(砧板)26和下部钳口28上,直至夹紧在缝钉施加组件16中的组织被缝合和切割。随后,所述电致动的拱托脱离机构20不用使用过强力或辅助外科手术(例如,使用抓钳)便可将拱托垫22、24脱开。
所述外科缝合和切割器械10如图1所示处于初始状态,而且闭合扳柄30和更远侧的发射扳柄32均从手枪握柄34释放。释放闭合板柄30向近侧地拉动闭合套管36,其为使砧板26枢转的细长轴18的外部。下部钳口28由框架基底(frame ground)38支撑,该框架基底被闭合套管36所包围,并可旋转地与手柄部分12接合。当接合闭合套管36和框架基底38以围绕细长轴18的纵向轴线旋转时,旋钮40允许闭合套管36往复地纵向运动。发射扳柄32或直接或间歇地与发射构件连接,特别是与发射杆42相连,其由传递发射运动到缝钉施加组件16的框架基底38引导,以进行缝合和切割。
用户可按下电源按钮44以激活由电池48供电的电致动拱托脱离机构20的控制模块46。手柄部分12上的可视化确认可以向用户给出该电致动的拱托脱离机构20的状态(例如,电源按钮44的彩色/闪光照明)。例如,所述电源按钮44和/或其他用户界面(未示出)可以被有利地多次按压以通过几种可获得的电致动拱托脱离机构20的操作状态触发,例如“电源接通”、“通过内部测试”、“插入拱托垫”、“系统装载/等待发射”、“检测错误”、以及“拱托过荷/未安装拱托垫发射”。通过将有线或者无线(例如,蓝牙)协议结合到界面控制模块46,以形成外部图形的用户界面(例如,个人计算机),可以获得额外的程序设计灵活性。在初始状态中,电致动拱托保持构件控制模块46(在所示的形式中)包括上部和下部锁闩臂50、52,其由电力向外推,从而可将上部拱托垫22如图所示地靠着所述砧板26的内表面插入,且可将下部拱托垫24放置并卡在所述下部钳口28的内表面上,特别是放置在接合于下部钳口28的细长缝钉槽56中的可替换的缝钉匣54上。
随着拱托垫22、24的插入和电源按钮44的再次按压至卡住,执行部件14可在内窥镜检查和腹腔镜检查中插入到手术部位。按压闭合扳柄30并在必要时放开其到在缝钉施加组件16中夹持一定量的组织。拉动闭合扳柄30至完全到手枪握柄34,使得闭合扳柄30并由此还有砧板26夹在闭合位置。然后,在单冲程或一系列冲程中按压发射板柄32,这取决于手柄部分12的构造,使得发射杆42经过整个发射行程。对于多发射冲程,在手柄部分12上的发射指示轮58给出关于所产生的发射量的可视指示。应该理解的是,所述发射杆42的远端包括刀具或者与刀具连接,该刀具横过在缝钉匣54中的垂直狭槽,以切割被夹持的组织和拱托垫22、24。所述发射杆也连接到一个楔形组件上,其以凸轮带动缝钉向上脱出缝钉匣54,穿过被夹持的组织和拱托垫22、24,靠着砧板26因而被闭合和成形。随后,通过发射结束行程(end-of-firing travel)释放机构和手柄部分12中的缩回偏压将发射杆42撤回。为了手动地释放和/或手动地缩回发射杆42,可以在手柄部分12上向上旋转手动缩回杆60。电致动拱托脱离机构20的控制模块46有利地感知发射已完成,例如通过响应手柄部分中的发射位置传感器62。在通过按压闭合释放按钮64松开闭合扳柄30的夹持时,将所述被支撑且缝合的组织(未示出)的切割端从缝钉施加组件16中释放出来。
不带有电致动拱托脱离机构20的手柄部分12的图示形式在Shelton等人的美国专利申请中有描述,其申请号为No.11/052,387,标题为“SURGICAL STAPLING INSTRUMENT INCORPORATING AMULTISTROKE FIRING MECHANISM WITH RETURN SPRINGROTARY MANUAL RETRACTION SYSTEM”(采用具有回位弹簧旋转手动缩回系统的多冲程发射机构的外科缝合器械),其公开内容在此全部引入作为参考。
电活化聚合物
尽管可以将大量电致动器(例如,螺线管)组合到缝钉施加组件16中,但在此描绘的图示形式有利地采用了电活化聚合物(EAP),其为导电的掺杂聚合物,它在施加电压时改变形状。实质上,导电的聚合物与某些形式的离子流体或凝胶和电极配合。离子从流体/凝胶中流入导电的聚合物或者从导电的聚合物中流出的流动通过施加的电位引起,并且这种流动引起聚合物的形状变化。依据所使用的聚合物和离子流体,电位在1V到4KV的范围内。一些EAPs在施加电压时收缩,而一些则膨胀。EAPs可以与机械装置配合,比如与弹性或柔性盘配合,来改变施加电压时所产生的效果。
有两种基本类型的EAPs并且每种有多种构造。该两种基本类型是纤维束和层压形式。纤维束由大约在30-50微米的纤维构成。这些纤维可以被织成非常类似于织物的一束并且因此常被称为EAP纱。这种类型的EAP在施加电压时收缩。电极通常由中央线芯和导电的外套组成,该外套还用来包含围绕纤维束的离子流体。一种可以在市场上买到的纤维EAP材料的例子由Santa Fe Science and Technology生产并且以商标PANIONTM纤维出售,而且在美国专利No.6,667,825中有描述,该专利的内容在此全部引入以供参考。
另一种类型是层压结构,其由一层EAP聚合物、一层离子凝胶和两个连接到所述层压件的每一侧上的柔性板构成。当施加电压时,方形的层压板沿一个方向膨胀,并且沿垂直方向收缩。一种可以在市场上买到的层压(板形)EAP材料的例子来自于Artificial Muscle Inc,其为SRI实验室的一个部门。板形EAP材料还可以从日本的EAMEX得到,其被称为薄膜EAP。
应当注意的是,EAPs在被加电时体积不变;它们仅仅是沿一个方向膨胀或收缩,而在横向上则与之相反地变化。可以通过将一侧包含到刚性结构上并将另一侧更像活塞一样的使用而以其基本形式使用层压形式。层压形式还可以被粘接到柔性板的任意一侧上。当给柔性板EAP的一侧加电时,其沿相反方向扩张弯曲柔性板。依据加电侧的不同,这允许该板在任一方向上弯曲。
EAP致动器通常由许多层或者成束的纤维一起组成,以便配合工作。EAP的机械构造确定EAP致动器和其运动的能力。可以将EAP形成长绳并且缠绕在单个中心电极上。柔性的外部外套管将为致动器形成另一个电极并且装有该装置的功能所必需的离子流体。在这种结构中,当将电场施加到电极上时,EAP绳缩短。EAP致动器的这种构造被称为纤维EAP致动器。同样,可以在柔性板的每一侧上以多层放置层压结构或者仅仅在其自身上放置多层以增加其性能。典型的纤维结构具有2-4%的有效应力,典型的层压形式利用更高的电压可获得20-30%。
例如,层压EAP材料可以由连接到EAP层上的正板电极层形成,该EAP层又连接到离子细胞层上,而离子细胞层又连接到负板电极层上。多个层压EAP复合材料可以通过它们之间的粘合剂层以堆叠的方式固定,以形成EAP板状致动器。可以理解的是,相对的EAP致动器可以被形成为沿任一方向有选择性地弯曲。
收缩式EAP纤维致动器可以包括纵向的铂阴极电线,该阴极电线穿过绝缘的聚合物近端帽,然后经过一细长的圆柱形腔体,该圆柱形腔体形成于经导电涂层以作为阳极使用的塑料圆柱形壁内。铂阴极电线的远端被嵌入绝缘的聚合物远端帽内。许多收缩聚合物纤维与阴极电线平行地布置并且围绕该阴极电线,它们的端部被嵌入到相应的端帽中。塑料圆柱形壁沿圆周围绕相应的端帽连接,以包围圆柱形腔体来将填充位于收缩聚合纤维和阴极电线之间的空间的离子流体或凝胶密封。当经过圆柱形壁(阳极)和阴极电线施加电压时,离子流体进入收缩的聚合物纤维内,使它们的外径膨胀,同时长度相应地缩短,由此将各端帽拉向彼此。
在图3-7中,电致动拱托脱离机构20的下部锁闩臂52通过电致动的圆柱形EAP致动器74可选择地保持下部拱托垫24,该致动器74位于在可替换缝钉匣54的缝钉匣主体80的左、右侧凸缘78、79上形成的孔76中。具体参见图4,聚合的缝钉匣主体80带有一个后部垂直狭槽82,其接收发射杆的刀具(未示出)。在聚合的缝钉匣主体80上形成多个垂直的缝钉孔84,每个缝钉孔都包含有受缝钉驱动器(未示出)支撑的缝钉。缝钉匣托架85位于聚合的缝钉匣主体80下方且环绕之以保持这些部件。左和右后部矩形EAP致动器86、88由左、右后部矩形孔90、92中伸出,该孔在后部垂直狭槽82的每一侧形成于缝钉匣主体80上。左、右后部锁闩臂94、96形成于缝钉匣托架85上并在其后部固定,随着各后部矩形EAP致动器86、88扩展,锁闩臂水平地向远端伸展,以向上前方弯曲(图7)。独立的左、右侧支架98、100分别包括多个相对的且向内弯曲的顶部和底面凸缘102、104,它们分别夹住左和右侧凸缘78、79。下部锁闩臂52由左、右侧支架98、100形成L型的凸缘,其覆盖了各左、右侧凸缘78、79并与之隔开一定间距。每个侧锁闩臂52和后部锁闩臂94、96都有一向下翻转的向内的边缘106,以帮助夹紧下部拱托垫24(图3、5)。在图6中,圆柱形EAP致动器74的电致动向上和向侧面旋转下部锁闩臂52,以使得下部拱托垫24脱离可替换缝钉匣54的上部压缩表面108。
在图8-11中,使电致动拱托脱离机构20的上部锁闩臂50弯曲,以用带有向内弯曲的左、右末端120、122紧密覆盖所述砧板26,所述末端分别与砧板26的对应外边缘平行。每个上部锁闩臂50受一对分别从左、右孔126、128伸出的圆柱形EAP致动器124电致动,该左、右孔形成于臂凹槽130处,凹槽130在侧面通过砧板26的上表面132形成。在砧板26的纵向顶点,每个上部锁闩臂50由紧固件134固定在砧板26上。因而,位于相应的紧固件134的每侧上的成对圆柱形EAP致动器124的膨胀导致每个上部锁闩臂50的左、右顶端120、122上升,且向远离所保留的上部拱托垫22的方向旋转,使其能从砧板26的形成缝钉的内压缩表面136脱离(图11)。
在图12-15中示出了缝钉施加组件16′的下部钳口28′的可替换缝钉匣54′的一种形式,其它方面在图3-6中描述,该缝钉匣进一步包括下部远侧锁闩140,它是对应于倾斜的导缘142和缝钉匣主体80′的上部压缩表面108弯成钝角的一块板锁闩140。下部远侧EAP致动器144从远侧EAP凹槽146伸出,粘附在所述缝钉匣主体80′和下部远侧锁闩140上,以向下拉动下部远侧锁闩140的钩状近端148与下部拱托垫24′的远侧接合,或者向上推动钩状近端148,脱离接合。下部拱托垫24′中的远侧轴向狭槽150对应于形成在下部远侧锁闩140上的近侧轴向狭槽152,以在没有刀具或者为了下部拱托垫24′不完全切割的情况下协助完成接合。
在图16-18中,用于电致动拱托脱离机构20′的替代左、右EAP拱托锁闩200、202作为EAP材料的向内开口的C通道形成,该材料嵌在缝钉匣主体80″的左、右侧凸缘78′、79′中,所述锁闩还被构形成当解除激励时其垂直收缩(图17),以夹住下部拱托垫24,而当被致动时产生膨胀以脱离(图18)。
在图19-20中,将替代的EAP锁定致动器74′以及可替代的左、右侧支架100′(在后描述)用于可替换的缝钉匣54中,而且与缝钉匣主体80的上部压缩表面108的垂直间距加大,以松散地保持下部拱托垫24。EAP锁定致动器74′处于垂直膨胀的锁定状态(图19),它向上将下部拱托垫24推动成在相应侧支架100′的上部凸缘240上紧密接合。EAP锁定致动器74′具有允许脱离的缩回解锁状态(图20)。应该想到的是,将EAP锁定致动器74′凹入缝钉匣主体80,提供了期望的伸长量,以使拱托垫24变形。可替代地或者附加地,EAP致动器可以被放置在上部凸缘240下面的一个相对位置上。
在图21中,圆形缝合器械310带有远侧和近侧拱托环312、314,如分解图所示,其从远侧和近侧圆形压缩表面316、318离开。从压缩表面316、318向内延伸并由手柄322有选择地控制的EAP锁闩320接合和脱离支撑环312、314。
尽管通过对几个实施例的描述对本发明进行了阐述,并且已经相当详细地描述了实施例,但是本申请人的意图不是约束或以任何方式将所附权利要求的范围限制到如此的细节。其它的优点和改进对于本领域的技术人员来说是显而易见的。
例如,尽管缝钉施加组件16以图示形式示出,但应该想到的是,电致动拱托脱离机构可以有利地用于利用诸如夹子、锚固器、缝合器等的紧固装置。
对于另一示例,尽管为清楚起见描述了手动操作的外科缝合和切割器械10,但应该想到的是,自动操作和/或控制的紧固设备可以结合与本发明的各方面一致的电致动拱托保持构件。
对于又一示例,对组织厚度和/或拱托材料的存在的感知可以有利地起动或中止发射,以避免当拱托材料有保证但未安装或拱托材料被安装但未获许可时的无意发射。
对于进一步的示例,电致动拱托保持构件可以包括被动弹性部件(例如,压力弹簧)和主动电部件的组合,该被动弹性构件提供夹持通道内的电源断开保持偏压。例如,通过压力弹簧到端帽的EAP纤维致动器可被致动而收缩,压缩所述压力弹簧以使拱托垫脱离。
作为另一示例,缝钉匣可由拱托垫制成,该拱托垫通过销、卷钳等附着在压缩表面上,或者可由位于下方的EAP致动器强制地使其脱离,该致动器使拱托垫和/或实施分离的附件变形。
作为进一步的示例,与本发明相一致的应用可以与电致动保持构件相结合,后者受到致动以完成与拱托垫的接合和/或为了所述拱托垫的脱离而脱开。例如,保持构件在没加电时,可具有摩擦接合,这允许在使用前插入拱托垫。其后的锁定EAP致动器的电激励可以有效地在使用前锁定拱托垫。可替代地或附加这样一个锁定EAP致动器,在脱离EAP致动器的缝合后对其激励,可以有效地减小与拱托垫的接合或摩擦接合而便于脱离器械。
作为另一附加的示例,尽管内窥镜检查和腹腔镜检查应用得益于本发明的各方面,但可以想到的是,开放式外科手术也可有益。

Claims (10)

1.一种用于将拱托材料固定在组织上的外科器械,其包括:
细长轴;
紧固件施放组件,其在远侧连接于细长轴,并包括相对的组织压缩表面;
电致动保持构件,其有选择地放置在接合位置,将拱托材料保持在所选的组织压缩表面上;以及
控制电路,其可操作地配置以产生控制信号,从而致动所述电致动保持构件,使所述拱托材料脱离。
2.根据权利要求1所述的外科器械,其特征为,所述电致动保持构件进一步包括电活化聚合物。
3.根据权利要求1所述的外科器械,其特征为,所述电致动保持构件进一步包括由电活化聚合物致动器移动的锁闩。
4.根据权利要求1所述的外科器械,其特征为,所述电致动保持构件进一步包括被放置成接收拱托材料的侧边缘的保持支架和电致动器,该电致动器带有被放置以有选择地进入通道的移动端。
5.根据权利要求4所述的外科器械,其特征为,所述电致动器的大小被可操作地设置为使所述保持支架向外变形,以释放拱托材料的被接收的侧边缘。
6.根据权利要求4所述的外科器械,其特征为,所述保持构件包括覆盖在所述拱托材料的被接收的侧边缘上的覆盖的凸缘,所述电致动器放置在所述拱托材料的被接收的侧边缘的相对侧,以保证在所述拱托材料上的锁定力。
7.根据权利要求1所述的外科器械,其特征为,所述电致动保持构件包括连接于所选定的组织压缩表面上的电活化聚合物致动器,该电活化聚合物致动器用于以最接近拱托材料的被接收的侧边缘的方式向外扩展所述电致动保持构件的基底部分,并弯曲所述电致动保持构件的在被接收的侧边缘与压缩表面相对的表面上方的锁闩部分,所述电活化聚合物致动器可操作地构造以由压缩的接合状态变化成膨胀的脱离状态。
8.根据权利要求7所述的外科器械,其特征为,所述电活化聚合物致动器可操作地构造以响应电激励,使基底部分向上、向外膨胀。
9.根据权利要求1所述的外科器械,其特征为,所述紧固件施放组件包括含有缝钉匣的下部钳口和可枢转地连接的上部钳口。
10.根据权利要求9所述的外科器械,其特征为,所述电致动保持构件包括覆盖且连接于所述上部钳口的顶面的弯曲的弹性构件,该弹性构件具有相对于所述上部钳口向内弯曲的端部,该弯曲的端部被定位成保持拱托材料的被接收的侧边缘,该拱托材料位于上部钳口的上部组织压缩表面上,所述电致动保持构件进一步包括一对电活化聚合物致动器,所述一对电活化聚合物致动器在所述弯曲弹性构件和所述上部钳口之间。
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