CN1301685C - 一种将支撑材料连接在手术用固定器械上的装置 - Google Patents
一种将支撑材料连接在手术用固定器械上的装置 Download PDFInfo
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- CN1301685C CN1301685C CNB021189870A CN02118987A CN1301685C CN 1301685 C CN1301685 C CN 1301685C CN B021189870 A CNB021189870 A CN B021189870A CN 02118987 A CN02118987 A CN 02118987A CN 1301685 C CN1301685 C CN 1301685C
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- A61B17/07207—Surgical 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
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Abstract
公开了一种将支撑材料可松开地连接在手术用缝合器械的组织夹紧件上的组件。该组件具有基本刚性的框架，当组件放在手术用缝合器械的组织夹紧件的顶面上时，框架可与顶面相连接。在框架的第一和第二侧面上连接了支撑材料，当组件放在手术用缝合器械的组织夹紧件的组织夹紧件的底面上时，支撑材料可靠在底面上。
Description
技术领域
本发明大体涉及将多个手术用固定件应用到组织内的手术用固定器械，更具体地涉及一种将支撑材料连接到手术用固定器械上以在组织内形成加固的手术用固定缝合线的新型方法。
背景技术
许多手术操作包括组织的切除术。一种这样的操作是减小肺的容量，在手术中切除一部分肺以治疗肺气肿。在人体组织的切除过程中遇到的一个问题是止血问题，尤其是在与缝合钉(staple)一起使用的时候。某些类型的人体组织例如肺部的薄脆组织更容易发生有关止血的问题，而且病变状态可加重这些问题。作为切除病变肺部组织的手段，可采用机械装置例如可打开的和内窥式的手术用缝合器和直线切割器。缝合钉可使血管组织止血，当用于肺部组织时，它还可为肺部提供良好的充气程度。手术用缝合器械具有多个缝合钉和一对相对的钳夹(jaw)，缝合钉位于可替换药筒中的多个相互错开的行中，一对钳夹中的至少一个可以移动。手术用缝合器械压挤药筒和钳夹之间的肺部组织，缝合钉射入到与将要切除的肺的病变部分接近的被压挤的组织中。刀片从已形成的缝合钉的最内的行之间纵向地穿过，将组织横切开。从手术部位取下手术用缝合器械，重新装上另一未使用过的缝合药筒，重复手术操作，直到切除和取下所需的肺部部分。在1995年5月16日转让给俄亥俄州辛辛那提市Ethicon Endo-Surgery的美国专利No.5415334中给出了一种可打开的直线切割器的示例，此专利通过引用结合于本文中。在1997年1月28日转让给俄亥俄州辛辛那提市Ethicon Endo-Surgery的美国专利No.5597107中给出了一种内窥式直线切割器的示例，此专利通过引用结合于本文中。
在以这种方式使用手术用缝合器中已知的问题是在已缝合的肺部组织中会产生空气泄漏。这种泄漏可能发生在切除线中，和/或缝合孔本身中。病变肺部组织通常薄且脆，当肺部重新膨胀时在缝合部位处会发生撕裂。这些空气泄漏可能是持久的，使得病人多留在医院数星期。作为减轻这些空气泄漏问题的方法，外科医生在需要缝合的部位采用支撑物或纱布材料，并通过这些支撑材料进行缝合，从而加固缝合线。支撑材料加固了脆性组织。组织被压在缝合孔上，导致止血效果增强。这也减少了组织在缝合线处撕裂的机率，并且减少了脆性组织的缝合脱开。
通常来说，这些加固材料可松开地固定在手术用缝合器械的钳夹件上，使得在射入后可用加固材料缝合肺部组织。在理想状况下肺部组织应“夹在”两层这种支撑材料之间。或者，支撑材料也可以用于许多其它的手术操作中，这些操作包括但不限于：子宫切除术、胃改道术、肠组织吻合术，或者任何其他需要加固缝合线或增强组织止血效果的手术操作。
将支撑材料可松开地连接在手术用缝合器械的钳夹件上存在着特殊的挑战。支撑材料必须牢固地固定在手术用缝合器械的钳夹件上，使其不会在正常的操作中掉落，又必须能容易地在射入缝合钉后从手术用缝合器械中取出。已经知道有多种粘合或机械的连接方法。粘合和机械的连接方法将在下文中进行讨论，这两种方法均具有缺陷。
在Gravener等人的美国专利No.5441193中介绍了一个采用粘合剂将支撑材料连接在直线切割器上的装置的示例。这种装置采用生物相容的氰基丙烯酸酯粘合剂将支撑材料连接在手术器械上。粘结结合沿着支撑材料的边缘部分进行，而且穿孔阴影线位于支撑材料(与粘结线相邻)内，使得可以从粘住的边缘部分上撕下支撑材料的未粘结的中间部分。然而，支撑材料上涂敷有粘合剂的部分就不能从装置上取下来。因此，从器械上取下支撑物(在射入后)会特别困难，因为必须同时撕下穿孔之间的所有材料，从而将手术用缝合器械从组织中松开。
所需要的是这样一种粘合剂，它能够将支撑材料可松开地连接到手术装置上，以使外科医生更容易地在射入缝合钉后从手术部位上取下手术装置。Francis等人的美国专利No.5752965提出了一种采用必须在即将使用前涂敷的可松开粘合剂将支撑材料或支撑带连接在手术用缝合器械上的方法。采用对准夹具来对准支撑带对，将粘合剂涂在各支撑带的暴露表面上，然后手术用缝合器械的钳夹在粘合剂和支撑带上闭合。当钳夹打开时，用粘性液体粘合剂将支撑材料连接在手术用缝合器械的钳夹和药筒上。粘性液态粘合剂可由羟丙基甲基纤维素、聚丙二醇和水组成。当以这种方式连接支撑材料时应提供可松开的粘合剂，这种粘性液态粘合剂的粘结效果是暂时性的。此外，连接过程较费时，而且对于每次射入都必须重复连接步骤。最后，一旦粘性粘合剂暴露在空气中，粘合剂中的挥发性成分开始蒸发。这就限制了这种粘性粘合剂在即将进行手术前或手术过程中的使用。
所需要的是一种不会随时间而变干或降解的可松开粘合剂。这样一种粘合剂可使支撑材料在生产厂处就连接在手术用缝合器械上，而且能够节省时间和费用。在Leslie Hamilton等人的欧洲专利EP1064883A1中介绍了一种由无毒、生物可吸收的脂族酯聚合物制成的可松开粘合剂，其为半晶体固态或粘性液态(蜂蜜状稠度)。该粘合剂的特征在于，在人体温度(37℃)下是其为可流动的，而且最好在室温(25℃)下可以流动。然而，粘合剂经常在卡车、船运集装箱、货运列车和仓库内遇到较高的温度(最高达50℃)，在此温度下粘合剂变得更具流动性。在较高温度的情况下，粘合剂会流到器械的其他部分或器械的包装上，这种流动会减低粘合剂的结合强度。
从以上讨论中可知，利用粘合剂将支撑材料连接在手术用缝合器上存在许多问题。在本领域中将支撑材料机械连接到手术用缝合器械上的方法也是众所周知的，而且可避免使用粘合剂所引起的问题。存在多种机械连接方法，其中一种常用的方法是在手术用缝合器械的夹紧件上设置套筒。该套筒可由弹性织物例如支撑材料形成，或者包含有连接在不同织物上的支撑材料的可松开带。在Cooper等人的美国专利No.5503638、Rayburn等人的美国专利No.5702409、Rayburn等人的美国专利No.5810855和McKean等人的美国专利No.5964774中介绍了多种这类套筒。
虽然套筒能有效地将支撑材料连接在手术用缝合器械的末端执行器上，然而套筒可能在手术过程中引起其它的复杂操作。例如，如果套筒由支撑材料制成的实心套筒形成，促动手术用缝合器械将支撑材料和组织缝合，并切断缝合线之间的支撑套筒和组织。该动作会使组织的一些部分(在切开线的任一侧)由支撑材料薄片而连接在一起。这就要求外科医生进入并切断支撑材料的切开套筒，从而将已切断的组织分离，并且去除支撑材料的任何不需要的部分。
所需要的是一种将支撑带可松开地连接在手术用缝合器械上的方法，其可在较长时间内保持有效性，在产品可能遇到的所有温度下保持可操作性，并且易于从手术用缝合器械上松开。
发明内容
根据本发明，公开了一种将支撑材料可松开地连接在手术用缝合器械的组织夹紧件上的组件。该组件具有基本上刚性的框架，当组件放在手术用缝合器械的组织夹紧件的顶面上时，框架可与顶面连接。在框架的第一和第二侧面连接了支撑材料，当组件放在手术用缝合器械的组织夹紧件的底面上时，支撑材料可靠在底面上。
具体地，本发明提出一种用于将支撑材料可松开地连接在手术用缝合器械的组织夹紧件上的砧座托架，所述砧座托架包括：
a.刚性的框架，用于当所述砧座托架放在所述手术用缝合器械的组织夹紧件的顶面上时，所述框架与所述顶面连接；和
b.支撑材料，与所述框架的第一和第二侧面相连接，从而形成一个有中空腔的的管形，并且当所述砧座托架放在所述手术用缝合器械的同一组织夹紧件的底面上时，所述支撑材料靠在所述底面上，所述底面与所述顶面是同一组织夹紧件的相反面；其特征在于，所述支撑材料具有多个沿所述框架的第一和第二侧面分布的多行间隔开的开口，所述开口与沿所述框架的所述第一和第二侧面分布向下延伸的L形钩相接合，用于将所述支撑材料连接在所述框架上，并且是通过单方向的直线运动将支撑材料从托架框架上拆下。
所述L形钩各具有从L形钩的一垂直部分水平地延出的臂。
所述框架还包括从所述框架的前端的内表面上延伸出的锁定或固定结构，用于与所述组织夹紧件上的配合结构相接合。所述锁定或固定结构是凸起的波纹或肋。所述框架由刚性的塑料制成。
所述支撑材料具有在所述框架的所述第一和第二侧面之间延伸的连续表面。所述框架为倒U形。
本发明也提出一种用于夹紧和缝合组织的手术用缝合器械，其包括：把手，在所述把手上连接了第一和第二相对的组织夹紧件，所述夹紧件可在容纳组织的打开位置和缝合组织的关闭位置之间移动，所述第一夹紧件中容纳了多个缝合钉；和如以上所述砧座托架，可松开地与所述第二夹紧件相连接。
所述框架还包括从所述框架的内表面延伸出的肋，所述第二夹紧件还包括与所述肋相接合的凹槽，以使所述砧座托架固定在所述第二夹紧件上。
所述框架由基本刚性塑料制成。所述支撑材料基本上覆盖了所述第二夹紧件的所述底面。
附图说明
本发明的新颖特征在所附权利要求中特别提出。然而，参考下文中的介绍并结合附图可以最佳地理解发明本身，包括发明结构和操作方法，以及发明的其它目的和优点。在附图中：
图1是手术用缝合器械的轴测图，显示了具有支撑带的末端执行器，支撑带通过本发明的热熔性粘合剂可松开地连接在砧座的第一夹紧表面和缝合药筒的第二夹紧表面上；
图2是图1所示手术用缝合器械的末端执行器的放大轴测图，为清晰起见还带有砧座的旋转剖视图，此轴测图显示了用涂敷器将熔化的本发明热熔性粘合剂涂在末端执行器的第一和第二夹紧表面上的步骤；
图3是手术用缝合器械的末端执行器的放大轴测图，为清晰起见还带有砧座的旋转剖视图，此轴测图显示了通过使支撑材料和位于组织夹紧表面上的熔化的本发明热熔性粘合剂接触，将支撑材料的条带连接在各组织夹紧表面上的步骤；
图4是将本发明的热熔性粘合剂冷却至设定温度点以下、使可松开粘合剂变成固态并将支撑材料的各部分粘结在各相应的组织夹紧表面上的步骤的轴测分解视图，；
图5是圆形缝合器械的轴测图，显示了在将熔化的本发明粘合剂涂敷在圆形缝合器械的砧座和缝合药筒上的步骤之前将支撑环放置在圆形缝合器械上，以便将支撑环与圆形缝合器械相连；
图6是手术用缝合器械的轴测图，显示了具有支撑带的末端执行器，支撑带通过砧座托架可松开地连接在砧座的第一夹紧表面上，并可通过相对于手术用缝合器械向末端的运动而移动；
图7是砧座托架上的部件的轴测分解视图，显示了当支撑带可松开地装配在托架外壳上时带孔支撑带的路径；
图8是图7所示砧座托架上的装配部件的轴测视图；
图9是砧座托架上部件的另一组件的末端视图；
图10是可拆下的托架外壳和带孔支撑带的另一实施例的轴测分解视图；和
图11是带有处于打开位置的砧座和与砧座相连的连接环的圆形缝合器械的轴测视图，其中带孔支撑环可拆下地且可旋转地连接在连接环上。
具体实施方式
现在参考附图，在所有视图中相同的标号表示相同的部件，图6显示了根据本发明制造的手术用缝合器械20。器械20具有本发明的砧座托架90，其可将带孔支撑带100可松开地连接在末端执行器35上。所示手术用缝合器械20是一种用于夹紧、缝合和切除人体组织的内部切割器(endocutter)，在本领域中已众所周知。或者，手术用缝合器械20也可以是多种其它的紧固器械例如圆形缝合器、缝合器、夹子灌肠器(clip applier)，或者是多种能进行单次或多次发射的其它紧固或缝合器械中的任一种。缝合钉或紧固件可包含在与手术用缝合器械整体形成的缝合药筒中，或者位于能够进行发射和替换以允许从同一手术用紧固器械中进行多次发射的可拆式缝合药筒中。本发明的组件在图6到11中表示出。
手术用缝合器械20具有便于操作者握住的把手25，从把手25向远端延伸出的细长轴30，以及从轴30向远端延伸出的末端执行器35。末端执行器35具有第一和第二组织夹紧件，它们中的至少其中之一可以在用于容纳夹紧件间的组织的打开位置和用于缝合夹紧件间的组织的闭合位置之间移动。第一组织夹紧件具有从轴30延伸出的固定沟槽31和安装在沟槽中的可拆式缝合药筒45。第二组织夹紧件是与第一组织夹紧件相对的可动砧座40。如图示，缝合药筒45设在固定沟槽31内，在缝合药筒45中容纳了多个缝合钉49。可动砧座40可操作地连接在从把手25上伸出的闭合扳机26上，并且响应于闭合扳机26的运动而移动。闭合扳机26从图6所示的打开位置朝向把手25的握柄27运动，可使砧座40从图6所示的打开位置移动到与可拆式缝合药筒45相邻的闭合位置(未示出)。发射扳机28朝闭合扳机26运动(当闭合扳机26和砧座40处于闭合位置时)，可发射出装在可拆式缝合药筒45中的多个缝合钉49。缝合钉49从可拆式缝合药筒45射出，穿过支撑带60和61，形成靠在砧座40上的紧密的“B”形(未示出)。手术用缝合器械20的一个示例是俄亥俄州辛辛那提市Creek路4545号的Ethicon-Endo Surgery公司的TSB35 EndopathTM ETS内窥式直线切割器。在同为转让的美国专利No.5597107中介绍了手术用缝合器械20和可拆式缝合药筒45，此专利通过引用结合于本文中。
如图6所示，第一支撑带60可松开地连接在可拆式缝合药筒45的第一组织夹紧表面46上。支撑带60可由多种支撑材料形成，这些材料包括新泽西州Somerville的Ethicon公司生产的VICRYL，密苏里州St.Louis的Sherwood-Davis and Geck公司生产的DEXON，德拉华州Wilmington的E.I.DuPont de Nemours & Co.生产的TEFLON。此外，其他材料包括动物材料例如鞣革牛心包膜，生物相容的人造橡胶如英格兰Gargrave的Ethicon公司生产的ε-己内酯乙交酯共聚物，或任何一种合适的支撑材料。在美国专利No.5468253中介绍了引起人们特殊兴趣的合适ε-己内酯乙交酯共聚物材料或泡沫，此专利通过引用结合于本文中。本发明的一个目的是将支撑带60和61可松开地连接在手术用缝合器械20的至少一部分上，可以使用较长时间，最多达两年或更长。
利用热熔性粘合剂连接支撑带
图2到4显示了利用本发明的固态粘合剂65分别将支撑带60和61可松开地连接到末端执行器35的第一和第二组织夹紧表面46，41上的步骤。固态粘合剂65在室温(25℃)下为固态，在人体温度(37℃)下为固态，在更高的温度下则熔化。这种类型的粘合剂称为热熔性粘合剂，在粘结过程中作为熔化的粘合剂66涂敷。当熔化的粘合剂66冷却时，它恢复为固态粘合剂65，形成粘结结合。在图2到4中，手术用缝合器械20的末端执行器35以放大形式示出，为清楚起见，砧座40剖开并旋转示出。或者，热熔性粘合剂65可用溶剂熔化，用于将支撑带60，61粘结到手术用缝合器械20上。在溶剂从熔化的粘合剂66中蒸发后，粘合剂66恢复为固态热熔性粘合剂65，并将支撑带60，61连接在手术用缝合器械20上。
图2显示了利用涂敷器70将熔化的粘合剂66涂在第一和第二夹紧表面46，41上的第一步骤。涂敷器70具有把手72，用于喷出热熔性粘合剂66的末端喷嘴71，位于把手72内用于熔化固态粘合剂65的末端的电阻加热装置75(未示出)，以及电线74。将电线74连接在电源80上可接通电阻加热装置75。把手72具有与电阻加热装置75相邻的冷却狭缝77，以防止过热。这类胶或粘合剂的涂敷器70在本领域中是众所周知的，如热熔喷胶枪，其适用于商业或家庭使用。热熔喷胶枪或粘合剂涂敷器70的一个非常好的例子是伊利诺斯州的Wauconda的FPL公司(邮编为60084)生产的SHUREBONDERPro 9000喷胶枪。
在图2中，棒状固态粘合剂65如图示地插入到把手72的近端开口中。当棒状固态粘合剂65插入时，它可操作地与进给机构(未示出)接合，进给机构与涂敷器的扳机73可操作地连接。促动涂敷器扳机73可使棒状固态粘合剂65在把手内朝远端运动，直到它接触到炽热的电阻加热装置75为止，棒状固态粘合剂65的末端部分被熔化。再次在涂敷器扳机73上施加压力，使熔化的粘合剂66从喷嘴71的喷口76挤出，并使棒状固态粘合剂65朝远端移动到涂敷器70中。尽管热熔喷胶枪或涂敷器70是涂敷固态粘合剂65的优选方法，但也可采用其它的粘合剂涂敷器。这些其它的粘合剂涂敷器包括但不限于可涂敷熔化的带状粘合剂的压力熔胶分配器，可涂敷熔化的液滴喷雾的喷雾器，以及可涂敷熔化的粘合剂膜的热滚筒。
在图2中，涂敷器70如图示地将数条线状熔化的粘合剂66涂敷在砧座40和药筒45的第一和第二组织夹紧表面46，41上。熔化的粘合剂在涂敷到支撑带60和61上之前先涂敷在这些表面上。如图示，熔化的粘合剂66涂敷在第二夹紧表面41上的缝合开口42之间。在第二组织夹紧表面41上设有两条较短的熔化的线状粘合剂66，其提供了足够的保持力，以将第一支撑带60连接在第二组织夹紧表面41上，然而又可容易地取下第一支撑带60。
如图示，在可拆式缝合药筒45的第一夹紧表面46上的纵向缝合狭缝47之间设有两行较长的熔化的粘合剂66。各缝合狭缝47具有活塞状的缝合钉驱动器48(未示出)，它可从深入可拆式缝合药筒45内的第一凹入位置移动至从第一组织夹紧表面46上延伸出的第二位置。在图2和3中，缝合钉驱动器48位于深入可拆式缝合药筒45的缝合狭缝47内的第一凹入位置中。“U”形缝合钉49(未示出)位于各缝合狭缝47内，并位于放置在狭缝中的缝合钉驱动器48之上。缝合钉驱动器48向第二位置运动，将缝合钉49从可拆式缝合药筒45中推出。在这些图中，缝合钉驱动器48和缝合钉49位于缝合狭缝47中，无法看到它们。缝合药筒45以及缝合钉驱动器48和缝合钉49的运动在本领域中已众所周知，可见于Williamson，IV等人的美国专利No.5415334，此专利通过引用结合于本文中。
如图3所示，一旦涂敷了熔化的粘合剂66，第二步就是将支撑带60和61放在各自的组织夹紧表面46，41上。如图示，第一和第二支撑带60和61朝向第一和第二组织夹紧表面46，41以及熔化的粘合剂66移动。图4显示了粘结过程的最后步骤，其中支撑带60和61放置就位，并压在各自的夹紧表面46，41上。当支撑带60和61被施压就位时，熔化的粘合剂66被压在支撑带61和夹紧表面46，41之间，并可冷却恢复为固态粘合剂65，将支撑带60，61连接在手术用缝合器械20上。
促动手术用缝合器械20可使缝合钉驱动器48从药筒45内的第一位置运动到第二位置，即从第一组织夹紧表面46上延伸出的位置。该动作同时抬起缝合钉49并使其压在砧座40上，并且向上抬起第一支撑带60使其离开药筒45的第一组织夹紧表面46。第一支撑带60向上的运动破坏了第一支撑带60和第一组织夹紧表面46之间的粘结结合，从缝合药筒45中松开了第一支撑带60。
或者，通常将熔化的粘合剂66放入缝合狭缝47并将第一支撑带61连接在缝合药筒45上，可将支撑带61粘结在药筒45上。熔化的粘合剂可以两种不同的方式放入缝合狭缝47内。第一种是用热熔喷胶枪将热熔性粘合剂直接注入缝合狭缝47内，将支撑带60粘结在缝合狭缝47上(未示出)。第二种是将熔化的粘合剂66放在相邻于缝合狭缝47(图3)的第一组织夹紧表面46上，并通过将第一支撑带60压在第一夹紧表面46上而迫使熔化的粘合剂66进入缝合开口48中，这样可使熔化的粘合剂66进入缝合开口48中。施压动作迫使一些熔化的粘合剂66从第一组织夹紧表面46进入到相邻的缝合狭缝47中，将支撑带61粘结在缝合狭缝47和第一组织夹紧表面46上(未示出)。当固态粘合剂65处于缝合狭缝47内且促动手术用缝合器械20时，缝合钉驱动器48和缝合钉49在缝合狭缝47内向上运动，并与狭缝47内的固态粘合剂65接触。与运动的缝合钉驱动器48和缝合钉49的接触使固态粘合剂65从狭缝47内喷出，破坏了第一支撑带60与可拆式缝合药筒45之间的粘结。
因此，当促动手术用缝合器械20来破坏缝合药筒45与第一支撑带60之间的粘结结合时，本发明的固态粘合剂65成为可松开的粘合剂。重要的是应注意到，采用促动手术用缝合器械20来破坏粘结结合不依赖于粘合剂的成分。也就是说，很多种粘合剂可以上述方式松开。除了热熔性粘合剂之外，其它可在室温下使用的粘合剂包括粘合剂如混炼胶、RTV硅酮、天然和合成橡胶、厌氧化合物、密封胶、可模制化合物如牙科用橡皮障的化合物，或者是韧性材料如蜡。此外，上述粘合剂或任一种其它的粘合剂如丙烯酸类树脂、氰基丙烯酸酯、环氧树脂等都可与粘结抑制剂一起使用。粘结抑制剂用作阻碍以降低粘结强度，可包括油、油脂、蜡、脱模剂、聚四氟乙烯，硅酮，或任何其它可降低粘结强度的表面污染剂。
缝合钉49从可拆式缝合药筒45中弹出还使第二支撑带61从第二组织夹紧表面41上松开，并使“U”形缝合钉49变成“B”形。通过使缝合钉穿过与第二组织夹紧表面41相连接的第二支撑带62并靠在砧座40内的缝合开口42上，可以使“U”形缝合钉49变成“B”形。当缝合钉49中的缝合线进入缝合开口42中时，缝合线的末端卷绕成“B”形，使固态粘合剂65从缝合开口42和第二组织夹紧表面41上松开。该动作使第二支撑带61从砧座40上分离(未示出)。
图5显示了用熔化的粘合剂66将支撑材料连接在圆形缝合器85上。在即将用熔化的粘合剂66将支撑环86粘结在圆形受压表面88，87上的步骤之前，支撑环86如图示地从第一和第二圆形受压表面87，88上脱开。在图5中，熔化的粘合剂66涂敷在第一受压表面87上，而且隐藏起来。
热熔性粘合剂的成分
固态粘合剂65可为能买到的热熔性粘合剂的任一种。热熔性粘合剂最好与人体组织生物相容，并且可以是天然的或合成的。天然生物聚合物尤其是多种生物蛋白质可用作热熔性粘合剂。这些蛋白质包括骨胶原、明胶、纤维蛋白、纤维结合素、纤维蛋白原、弹性硬蛋白、血清白蛋白、血红蛋白、卵白蛋白等，或者是它们的任何化合物。另外，可以单独使用或与其他材料一起使用多醣，例如透明质酸、硫酸软骨素、羟乙基淀粉、羟乙基纤维素、羟丙基纤维素、羧乙基纤维素、聚N-乙酰葡萄胺/脱乙酰壳多糖、琼脂糖和藻酸盐。
合成材料可以包括聚(乳酸)、聚(羟基乙酸)、聚(羟基丁酸)、聚(膦嗪)、聚酯、聚乙二醇、聚环氧乙烷、聚丙烯酰胺、聚甲基丙烯酸羟乙酯、聚乙烯吡咯烷酮、聚乙烯醇、聚丙烯酸、聚醋酸酯、聚己酸内酯、聚丙烯、尼龙等。同样，合适的生物相容的、生物可吸收的聚合物可包括但不限于选自脂肪族聚酯、聚(氨基酸)、共聚(醚酯)、聚草酸亚烷基酯、聚酰胺、酪氨酸衍生的聚碳酸酯、聚(亚氨基碳酸酯)、聚原酸酯、聚氧杂酯(polyoxaesters)、聚酰胺酯、包含胺基的聚氧杂酯、聚(酐)、聚膦腈、生物分子(即生物聚合物，如骨胶原、弹性硬蛋白、生物可吸收的淀粉等)及其混合物的聚合物。
对于固态粘合剂65来说，引起人们特别兴趣的是一种通常在低于40℃的温度下为固态的共聚物。优选的共聚物是ε-己内酯或亚丙基碳酸酯和乙交酯的共聚物。共聚物为ε-己内酯和乙交酯的共聚物则更好。ε-己内酯的量可在30至45摩尔百分比之间，其余为乙交酯。理想上共聚物可由36∶64(摩尔/摩尔)的ε-己内酯乙交酯共聚物组成。共聚物是含有少于百分之一的未反应的单体的人造橡胶，未反应的单体由质子核磁共振摄谱仪测定。共聚物的特性粘度可在25℃下在0.1克/分升(g/dL)的六氟异丙醇(HFIP)的溶液中测定，其浓度可在约0.8g/dL至约3.2g/dL的范围内，较理想在约0.6g/dL至约2.4g/dL的范围内，最好为1.6g/dL。在一个特别的优选实施例中，优选的固态粘合剂和优选的支撑材料可由同一种生物可吸收性材料，即ε-己内酯乙交酯共聚物形成。
固态粘合剂65的特征为在高达40℃的温度下是固态，在更高温度40.1℃至600℃之间熔化但不降解。较理想是在较高的温度120℃至140℃之间最好是在180℃下熔化但不降解的固态粘合剂65。上述共聚物可根据美国专利No.5468253、No.5133739和No.4605730中的介绍来制备，这些专利通过引用结合于本文中。
将支撑带连接在砧座上的其它装置及方法
图6到11显示了将支撑带连接在图1所示手术用缝合器械20的砧座40上的另一装置及方法。图6显示了带有固定在砧座40上的砧座托架90和可拆下地连接在砧座托架90上的支撑带的手术用缝合器械20。当完全固定时，砧座托架90在砧座40上滑动并锁住砧座40。通过取下或替换砧座托架90可容易地解除锁定。
如图7到9所示，砧座托架90由框架或托架外壳91和带孔支撑带100装配而成。托架外壳91是中空的，便于在砧座40上滑动，并具有倒“U”形的托架主体92，且具有从主体向远端延伸出的前端95。前端95可以是钝圆的或可防止损伤的形状，以防止在手术部位放置手术用缝合器械20时损伤组织。弹性件96将前端95连在托架主体92的远端。在前端95的内表面(未示出)上设有锁定或固定结构97，以便将砧座托架90可松开地与手术用缝合器械20的砧座40接合。固定结构97可以是凸起的波纹或肋，其与手术用缝合器械20的砧座40上的凹进配合结构(未示出)相接合。将前端95从砧座40上抬起(当固定结构97与砧座40相接合时)而使弹性件96偏转，同时将固定结构97从砧座40的凹进配合结构上抬起，并从砧座40上松开托架外壳。在托架主体92的每一侧向下延伸了多个连接结构如“L”形钩93，臂94从“L”形钩93的垂直部分或第一部分93a上朝远端方向水平地延伸。尽管钩93为优选的实施例，然而在托架外壳91上可以增加长钉、臂、凸台、浮凸件或多种可松开构件中的任一种。托架外壳91可以由刚性或半刚性材料如工程塑料制成，这种材料的例子可包括液晶聚合物、聚碳酸酯、聚苯乙烯，或者多种医疗用等级的热成形工程塑料或热固性工程塑料中的任一种。此外，托架外壳91也可以由任何金属材料如铝、钢、不锈钢、铜或者其化合物或合金形成。
带孔支撑带100是由上述任一种支撑材料形成的矩形薄片，其具有多行间隔开的从薄片中穿过的开口101。通过将各水平臂94完全地套进带孔支撑带100中的各个开口101中直到开口101与“L”形钩93的第一部分93a或垂直部分相接触为止，可以将带孔支撑带100连接在托架外壳91上。带孔支撑带100相对于托架外壳91朝远端运动，可使开口101脱离臂94，并从托架外壳91上松开带孔支撑带100。因此，通过单方向的直线运动可将带孔支撑带100从托架外壳91上拆下。图7所示箭头表示当臂94套进带孔支撑带100中时开口101的路径。
图8是显示了带孔支撑带100与托架外壳91的优选组件的轴测图。在此组件中，钩93的各臂94如图示地放入带孔支撑带100内的各个开口101中。当臂94与开口101装在一起时，由于臂94放入开口101中，在带孔支撑带100的边缘上会出现微小波纹。当优选的砧座托架组件90安装在砧座40上时，带孔支撑带100通过砧座40的第二夹紧表面41而从托架外壳91上脱开，使带孔支撑带100变平。
图9是带孔支撑带100与托架外壳91的另一组件的剖视图。在此图中，带孔支撑带100的边沿着各行开口101向上折起成基本上为“U”形的形状。然后，“U”形带孔支撑带100的垂直边放入钩93中，各臂94套进各自的开口101中。这种连接方法在所连接的带孔支撑带100上产生了基本平整的水平部分。
在手术过程中，砧座托架90以如下方式使用。砧座托架90(包括带孔支撑带100)在手术用缝合器械20的打开的砧座40上滑动。接下来砧座40闭合，手术用缝合器械20的末端执行器35插入病人体内。砧座40打开，末端执行器放在选定的手术部位处的组织上。砧座40闭合，夹紧砧座40的第二夹紧表面41和可拆式缝合药筒45的第一夹紧表面46之间的组织。促动手术用缝合器械20，将带孔支撑带100缝合在组织上，并切断缝合线之间的组织和支撑物。砧座40打开，手术用缝合器械20从手术部位中朝近端方向抽回。当抽回手术用缝合器械20时，已缝合的带孔支撑带100仍连接在组织上，托架外壳91的臂94滑出带孔支撑带100中的开口101，使带孔支撑带100脱离手术用缝合器械20。为了在手术用缝合器械20中重新装上新的砧座托架90，外科医生必须将手术用缝合器械20从病人身上取下。接着，外科医生通过抬起前端95而从砧座40上松开固定结构97并将托架外壳91从砧座40上滑出，从而从砧座40上将使用过的托架外壳91取下。将新的砧座托架90滑入砧座40中，完成重装过程。
图10显示了可拆式托架外壳191的另一实施例，在操作过程中其可以同时从砧座40和带孔支撑带100上拆下，并从手术用缝合器械20上松开带孔支撑带100。可拆式托架外壳191具有细长的托架主体192、带有臂194和从中延伸出的第一部分193a的钩193，以及前端195。从托架外壳191的近端延伸出凸出部198，其具有固定地连接在凸出部198上的长缝合线199。带孔支撑带100可以以如前面图8和9中所述的任一种方式与可拆式托架外壳191装配在一起。
在手术过程中，连接有带孔支撑带100的可拆式托架外壳191在末端执行器35的砧座40上滑动。然后，线199沿着轴30从可拆式托架外壳91向近端延伸，并终止于手术用缝合器械20的把手25附近的自由端。将末端执行器35放入病人体内(通过套针)，可将缝合线199的自由端留在病人的体外。在将末端执行器35夹紧在组织上并促动手术用缝合器械20之后，通过拉动线199将带孔支撑带100从手术用缝合器械20上松开。拉动线199同时使可拆式托架外壳191向远端运动，并从砧座40中脱离。当可拆式托架外壳191向远近端运动时，臂194从带孔支撑带100内的开孔101中抽回，将带孔支撑带100从可拆式托架外壳191和砧座40上松开。打开砧座40，从末端执行器35上松开带孔支撑带100和所连接的组织。然后，用线199通过套针从病人体内抽回使用过的可拆式托架外壳191。
图11表示了将带孔支撑材料可拆卸地连接在缝合器械，即圆形缝合器85上的另一实施例。在此实施例中，支撑材料通过旋转运动而不是前面所述的直线运动从圆形缝合器械上脱开。如图所示，圆形缝合器85具有打开的圆形砧座89和纵向轴。在圆形砧座89上连接或形成了连接环105。突出钩106从连接环105上朝着器械主体向远端延伸出，其具有突出臂106a。突出臂106a绕圆形砧座89的圆周以相同的逆时针方向从突出钩106上延伸出。突出钩106径向向外地间隔开，使得圆形砧座89可以完全闭合，而不会使突出钩106变形。
带孔支撑环107连接在从圆形砧座89上延伸出的突出钩106上。围绕带孔支撑环107的圆周间隔地设有多个凸台108，在各凸台108上延伸穿过了凸台开孔109。如图所示，在带孔支撑环107的圆周上以相等间距分布了四个凸台108，以及相同数目的突出钩106。为了将带孔支撑环107可拆下地连接在连接环105的突出钩106上，应将凸台开孔109放在凸台臂106a上，并使带孔支撑环107顺时针旋转。类似地，逆时针旋转可取下已连接的带孔支撑环107。或者，凸台臂106a可沿顺时针方向延伸，在这种情况下逆时针旋转带孔支撑环107以进行安装，而顺时针旋转则可将其取下。在将带孔支撑环107缝合在组织上之后，圆形砧座89打开，圆形缝合器85顺时针方向旋转，将臂94从凸台开孔处抽回，并从圆形缝合器85上松开带孔支撑环107。由于圆形缝合器85是单次操作的器械，连接环105可以永久性或可拆下地连接在圆形砧座89上。或者，通过将相邻于第一圆形受压表面88的第二连接环105与朝远端延伸出的突出钩106(未示出)连接在一起，可以将带孔支撑环107连接在第一圆形受压表面88上。如果连接环105与第一和第二圆形受压表面88，87相邻地连接，必须注意要确定环钩连接的方向，以防止在闭合时相接触，并且连接环105上的臂94应处于同一方向(未示出)。当臂94处于同一方向时，旋转圆形缝合器85可同时拆下两个带孔支撑环107。
虽然已经显示且介绍了本发明的特殊实施例，但是在不脱离本发明的精神实质和范围的前提下，可以对装置和/或方法进行修改。在介绍本发明时所用的术语是描述性的而不是限制性的。
Claims (11)
1.一种用于将支撑材料可松开地连接在手术用缝合器械的组织夹紧件上的砧座托架，所述砧座托架包括：
a.刚性的框架，用于当所述砧座托架放在所述手术用缝合器械的组织夹紧件的顶面上时，所述框架与所述顶面连接；和
b.支撑材料，与所述框架的第一和第二侧面相连接，从而形成一个有中空腔的的管形，并且当所述砧座托架放在所述手术用缝合器械的同一组织夹紧件的底面上时，所述支撑材料靠在所述底面上，所述底面与所述顶面是同一组织夹紧件的相反面；
其特征在于，所述支撑材料具有多个沿所述框架的第一和第二侧面分布的多行间隔开的开口，所述开口与沿所述框架的所述第一和第二侧面分布向下延伸的L形钩相接合，用于将所述支撑材料连接在所述框架上，并且是通过单方向的直线运动将支撑材料从托架框架上拆下。
2.根据权利要求1所述的组件，其特征在于，所述L形钩各具有从L形钩的一垂直部分水平地延出的臂。
3.根据权利要求1所述的组件，其特征在于，所述框架还包括从所述框架的前端的内表面上延伸出的锁定或固定结构，用于与所述组织夹紧件上的配合结构相接合。
4.根据权利要求3所述的组件，其特征在于，所述锁定或固定结构是凸起的波纹或肋。
5.根据权利要求1所述的组件，其特征在于，所述框架由刚性的塑料制成。
6.根据权利要求1所述的组件，其特征在于，所述支撑材料具有在所述框架的所述第一和第二侧面之间延伸的连续表面。
7.根据权利要求1所述的组件，其特征在于，所述框架为倒U形。
8.一种用于夹紧和缝合组织的手术用缝合器械，其包括：
a.把手，在所述把手上连接了第一和第二相对的组织夹紧件，所述夹紧件可在容纳组织的打开位置和缝合组织的关闭位置之间移动，所述第一夹紧件中容纳了多个缝合钉；和
b.如权利要求1的砧座托架，可松开地与所述第二夹紧件相连接。
9.根据权利要求8所述的器械，其特征在于，所述框架还包括从所述框架的内表面延伸出的肋，所述第二夹紧件还包括与所述肋相接合的凹槽，以使所述砧座托架固定在所述第二夹紧件上。
10.根据权利要求8所述的器械，其特征在于，所述框架由基本刚性塑料制成。
11.根据权利要求8所述的器械，其特征在于，所述支撑材料基本上覆盖了所述第二夹紧件的所述底面。
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| CNB021189994A Expired - Lifetime CN1294883C (zh) | 2001-05-07 | 2002-05-08 | 将加强材料固定到手术钉合装置上的胶粘剂 |
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| US10357249B2 (en) | 2011-12-14 | 2019-07-23 | Covidien Lp | Surgical stapling apparatus including releasable surgical buttress |
| US11229434B2 (en) | 2011-12-14 | 2022-01-25 | Covidien Lp | Surgical stapling apparatus including releasable surgical buttress |
| CN103876801A (zh) * | 2012-12-19 | 2014-06-25 | 柯惠Lp公司 | 附接到钉仓表面的支撑件 |
| CN103932747A (zh) * | 2013-01-23 | 2014-07-23 | 柯惠Lp公司 | 包括手术支撑件的手术装置 |
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