CN1386477A - 将加强材料固定到手术钉合装置上的胶粘剂 - Google Patents
将加强材料固定到手术钉合装置上的胶粘剂 Download PDFInfo
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Abstract
一种用来钳夹和钉合人体组织的手术钉合装置。该装置带有把手和连接在所述把手上的相对的第一和第二组织钳夹件。这些钳夹件可在开启位置和关闭位置之间活动,当处于开启位置时可容纳在它们之间的组织,当处于关闭位置时可钉合在它们之间的组织。第一和第二钳夹件中至少一个装有若干U形钉。该装置还包括用热熔性胶粘剂可释放地连接在第一和第二组织钳夹件中至少一个上面的加强材料垫片。加强材料设置在钳夹件上,因此用U形钉可以将加强材料连接到钳夹件之间的组织上。
Description
技术领域
本发明总的来说涉及将若干手术用固定件固定到人体组织中的手术固定装置,更具体地讲,涉及为了在组织中形成增强的手术固定线而将加强材料固定到手术钉合装置上的一种新颖方法。
背景技术
许多手术方法中都包括人体组织的切除。其中有一种方法是肺容量减少手术,通过将肺的一部分切除来治疗肺气肿。在切除人体组织的过程中所碰到的一个问题,尤其是在使用U形钉的情况下,是止血的问题。对于某些种类的人体组织来说更易于碰到止血问题,比如在肺脏中比较薄的脆弱组织,且病变状况会使这个问题更加严重。机械装置如开式和通过内窥镜的手术钉合器和直线切割器被用作切除病变的肺组织的工具。U形钉可以在血管结构中产生止血作用,而且当应用于肺组织时也可以提供良好的防漏气(pneumostasis)的作用。手术钉合装置包括在可更换钉盒中交错排列成多行的若干U形钉和一对相对的钳夹,钳夹中至少有一个是可以活动的。手术钉合装置压紧位于钉盒和钳夹之间的肺组织,然后将U形钉发射到紧靠要切除病肺部分的受压组织中。切割刀片沿纵向在成形的U形钉的最内行之间滑过以切割组织。将手术钉合装置从手术部位上移开,重新装入另一个未发射的钉盒,然后重复此过程直至肺脏中所要求的部分被切除和移去。在1995年5月16转让给俄亥俄州辛辛那提市Ethicon Endo-Surgery公司的美国专利5,415,334中公开了一种用开式直线切割器实例,在此引用参考其内容。在1997年的1月28日转让给俄亥俄州,辛辛那提市Ethicon Endo Surgery公司的美国专利5,597,107中公开了一种内窥镜式直线切割器的实例,在此引用参考其内容。
以这种方式使用的手术钉合器有一个大家知道的问题是会在钉合的肺组织中产生漏气。漏气可以出现在切割线和/或钉眼本身的位置。由于病肺组织薄而脆弱,因此当肺脏再充气时常常会在U形钉位置被撕裂。漏气问题可以是持久性的,并可能使病人的住院时间延长到几个星期。作为减轻漏气问题的一种方法,外科医生通过在所要求的钉合部位应用加强或衬垫材料来增强钉合线,然后通过加强材料进行钉合。加强材料使脆弱组织增强。压紧在钉眼上的组织可以提高防止漏气的效果。这样减少了在钉合线位置的组织撕裂,并降低了U形钉从脆弱组织中拔出的可能性。
这些增强材料一般可释放地固定在手术钉合装置的钳夹件上,因此通过发射可以将增强材料钉合到肺组织上。肺组织最好夹在两层这样的增强材料中间。另一方面,加强材料可用于其它一些手术方法中,比如但不限于:子宫卵巢切除术、胃绕道术、肠组织吻合术或其它任何需要增强钉合线或提高组织止血能力的手术。
要将加强材料可释放地固定到手术钉合装置的钳夹件上是一种特殊的挑战。加强材料必须稳固地连接在手术钉合装置的钳夹上使其在正常的操作过程中不会脱落,但在U形钉被发射时加强材料又必须很容易地从手术钉合装置上松开。已经知道有许多种用胶粘剂和机械固定的方法。下面将介绍用胶粘剂固定和机械固定的方法,两种方法都有其不足之处。
Gravener等人在美国专利No.5,441,193中介绍了一种用胶粘剂将加强材料固定到直线切割器上的装置实例。这种装置用一种生物相容的腈基丙烯酸酯粘合剂将加强材料固定到手术器械上。沿加强材料的边缘部分涂上粘合剂,且加强材料中穿有连成虚线状的孔洞(靠近胶缝处),因此可以将未涂粘胶的加强材料中心部分从已经粘合的边缘部分上撕下。然而,加强材料中涂有胶粘剂的部分并不能从装置上松开。结果,要将加强材料从器械上除去(在发射之后)会特别困难,因为必须将孔洞之间的所有材料同时撕下才能将手术钉合装置从组织上松开。
需要有一种能够将加强材料可释放地固定到手术装置上的胶粘剂,使得外科医生在发射之后能够更加容易地将手术装置从手术部位中取出。Francis等人的美国专利5,752,965介绍用一种可释放的胶粘剂将加强材料或垫片固定到手术钉合装置上的方法,其中胶粘剂必须刚好在使用之前涂敷。要用校准定位机构来校准一对加强垫片,将胶粘剂涂敷到每一加强垫片的暴露表面上,接着将手术钉合装置的钳夹合拢到胶粘剂和加强垫片上。当钳夹打开时,加强材料被粘性的液体胶粘剂固定到手术钉合装置的钳夹和钉盒上。这种发粘的液体胶粘剂是由羟丙基甲基纤维素、聚丙二醇和水组成的。虽然这种固定加强材料的方法提供了一种可释放的胶粘剂,但是这种粘性液体胶粘剂的粘合作用是暂时性的。此外,固定过程很费时,而且对于每一次发射都必须重复该固定步骤。最后一点,只要这种粘性胶粘剂暴露于空气中,胶粘剂中的挥发性组分便会开始挥发,使得这种粘性胶粘剂只能刚好在手术之前或手术过程中才能使用。
需要有一种不会随着时间的过去而变干或分解的可释放胶粘剂。这样的胶粘剂使得加强材料能够在制造工厂内固定到手术钉合装置上,从而节约时间和成本。Leslie Hamilton等人的欧洲专利申请EP 1064883A1介绍了一种由可生物吸收的无毒脂族酯聚合物制成的可释放胶粘剂,它是半晶状的固体或粘性液体(具有象蜜一样的稠度)。这种胶粘剂的特点是在体温(37摄氏度)下可以流动,而且最好是在室温(25摄氏度)下可以流动。但是,在卡车、海运集装箱、铁路车厢和仓库中常常遇到的更高温度(达到50摄氏度)的情况下,这种胶粘剂的流动性会变得更强。在这种较高温度的情况下,胶粘剂会迁移到器械的其它部分或器械舱中而使粘结强度减小。
正如从上面的讨论中所看到的那样,要用胶粘剂将加强材料固定到手术钉合器上会碰到很多问题。用机械方法将加强材料固定到手术钉合装置上在本技术领域中也是众所周知的,而且用机械方法可以避免使用胶粘剂时所出现的问题。有很多种机械固定的方法,其中有一种通常使用的方法是将一个套管安置在手术钉合装置的钳夹件上。套管可以用柔性织物如加强材料制成,或者可以包含固定在不同织物上的可释放的加强材料垫片。在Cooper等人的美国专利No.5,503,638、Rayburn等人的美国专利No.5,702,409和McKean等人的美国专利No.5,964,774中介绍了许多种这样的套管。
虽然利用套管可以有效地将加强材料固定到手术钉合装置的末端执行器上,但套管在手术过程中会产生其它新的问题。例如,在套管是加强材料的固体套管的情况下,发射手术钉合装置将加强材料和组织钉合在一起,然后切断加强材料套管和钉合线之间的组织。这个操作过程会使部分组织(在切割线的两侧)通过加强材料垫片连接在一起。这就要求外科医生检查并切开加强材料套管以分开被切断的组织,并将加强材料的任何多余部分除去。
需要有一种将加强垫片可释放地固定在手术钉合装置上的方法,使得固定作用可以保持长期有效,在产品可能遇到的所有温度条件下仍能正常使用,而且使得加强垫片能够很容易地从手术钉合装置上释放。
发明内容
根据本发明,提供了一种用来钳夹和钉合人体组织的手术钉合装置。该装置带有把手和连接在所述把手上的相对的第一和第二组织钳夹件。这些钳夹件可在开启位置和关闭位置之间活动,当处于开启位置时可容纳在它们之间的组织,当处于关闭位置时可钉合在它们之间的组织。第一和第二钳夹件中至少一个装有若干U形钉。该装置还包括用热熔性胶粘剂可释放地固定在第一和第二组织钳夹件中至少一个上的加强材料垫片。加强材料设置在钳夹件上,因此用U形钉可以将加强材料固定到钳夹件之间的组织上。
根据本发明,还提供了一种可安装到外科钉合装置的末端执行器中的钉盒。钉盒中包括装有若干U形钉的部件。该部件中包括可将其本身可释放地固定到手术器械上的机构。钉盒还包括用热熔性胶粘剂可释放地固定在所述部件上的加强材料垫片。
根据本发明,还提供了一种在加强材料被胶粘剂固定到钉合器械上后,将加强材料从钉合器械上松开的方法。这种方法中的钉合器械包括可在开启位置和关闭位置之间活动的相对的第一和第二组织钳夹件,当处于开启位置时可容纳在它们之间的组织,当处于关闭位置时可钉合在它们之间的组织。第一和第二钳夹件中至少一个装有若干U形钉,而且用胶粘剂将加强材料垫片可释放地固定在第一组织钳夹件上。接着使器械处于开启位置并将组织插入钳夹件之间。然后,通过闭合器械并将加强材料钉合到组织上使加强材料从第一钳夹件上释放。U形钉的运动使胶粘结合分开,从而使加强材料脱离第一钳夹件。
附图说明
在所附权利要求中对本发明的新颖特征作了详细阐述。但是本发明的结构和操作方法以及其它的目的和优点,通过下面结合附图的说明得以充分理解,其中:
图1是手术钉合装置的等轴视图,其中末端执行器上带有用本发明的热熔性胶粘剂可释放地连接在砧座的第一钳夹面和钉盒的第二钳夹面上的加强垫片;
图2是图1所示手术钉合装置中末端执行器的放大等轴视图,为了清楚起见砧座断开并作了旋转,该图示出了用敷胶器将熔化了的本发明热熔性胶粘剂涂敷到末端执行器的第一和第二钳夹面上的步骤;
图3是手术钉合装置中末端执行器的放大等轴视图,为了清楚起见砧座断开并作了旋转,该图示出了通过将加强材料与熔化了的本发明热熔性胶粘剂接触而使加强材料垫片固定到每一个组织钳夹面上的步骤;
图4是分解等轴视图,示出了将本发明的热熔性胶粘剂冷却到凝固点以下的步骤,此时可释放胶粘剂变成固体而使加强材料各部分粘附到各自相应的组织钳夹面上;
图5是圆形钉合器械的等轴视图,示出了在将本发明的熔化胶粘剂涂敷到圆形钉合器械的砧座和钉盒上之前,放在圆形钉合器械上的待固定加强垫圈;
图6是手术钉合装置的等轴视图,其中末端执行器上带有通过砧座滑套可释放地固定在砧座的第一钳夹面上的加强垫片,加强垫片相对于手术钉合装置向远侧移动时可被除去;
图7是砧座滑套各部件的分解等轴视图,示出了把带孔加强垫片与滑套外壳装配到一起时,带孔加强垫片的移动路径;
图8是图7中砧座滑套各部件装配好时的等轴视图;
图9是砧座滑套各部件的另一种组件的远端视图;
图10是可更换滑套外壳和带孔加强垫片的另一个实施例的分解等轴视图;和
图11是圆形钉合器械的等轴视图,其中砧座处于打开位置,一连接环固定在砧座上,带孔加强垫圈可拆卸并可转动地连接在该连接环上。
具体实施方式
现在参见附图,在所有附图中相同的标号代表相同的部件。图1示出了根据本发明制造的手术钉合装置20。装置20带有一末端执行器35,用本发明的热熔性胶粘剂将第一加强垫片60和第二加强垫片61固定在其上。所示手术钉合装置20是本技术领域中都知道的一种内切割器,用来钳夹、钉合和切割人体组织。或者,手术钉合装置20可以是一种固定装置如圆形钉合器、钉合器、夹紧器、或任何一种能够单发射或多发射的其它固定或钉合装置。U形钉或固定件可以装在与手术钉合装置整体形成的钉盒中,或者装在可更换钉盒中,使得同一个手术钉合装置可以进行多次发射。
手术钉合装置20包括可供操作人员握住的把手25、从把手25向远侧延伸的细长轴30、以及从轴30向远侧延伸的末端执行器35。末端执行器35包括可在开启位置和关闭位置之间活动的第一和第二组织钳夹件,当处于开启位置时可容纳在它们之间的组织,而当处于关闭位置时可钉合在它们之间的组织。第一组织钳夹件包括从轴30延伸出来的固定槽31和安装在固定槽31中的可更换钉盒45。第二组织钳夹件是与第一组织钳夹件相对的一活动砧座40。所示钉盒45位于固定槽31中,并包含若干放在里面的U形钉49。活动砧座40可操作地连接在从把手25伸出的关闭扳机26上,并随关闭扳机26的移动而移动。将关闭扳机26从图1所示的开启位置向握柄27移动时,会使砧座40从图1所示的开启位置向靠近可更换钉盒45(未示出)的关闭位置移动。将发射扳机28向关闭扳机26移动(当关闭扳机26和砧座40处于关闭位置时)会发射出装在可更换钉盒45里面的若干U形钉49。U形钉49从可更换钉盒45中射出,穿过加强垫片60和61,然后顶在砧座40上而形成闭合的B形。一种手术钉合装置20的实例是由美国俄亥俄州辛辛那提市Creek路4545号的Ethicon-Endo Surgery公司生产的TSB35 Endopath TM ETS内窥镜式直线切割器。在共同转让的美国专利No.5,597,107中对手术钉合装置20和可更换钉盒45作了大致介绍,在此引用参考其内容。
如图1所示,第一和第二加强垫片60和61可释放地附着在可更换钉盒45的第一组织钳夹面46和砧座40的第二钳夹面41上。加强垫片60和61可以由各种加强材料制成,包括由新泽西州Somerville市Ethicon公司生产的VICRYL、由密苏里州圣路易斯市Sherwood-Davis和Geck公司生产的DEXON、以及由特拉华州Wilmington市E.I.DuPont de Nemours&公司生产的TEFLON。另外,其它材料还包括动物材料如鞣制牛心包膜、生物适应人造橡胶如英国Gargrave镇的Ethicon公司生产的ε-己内酯乙交酯、或任何一种适当的加强材料。适当的ε-己内酯乙交酯材料或泡沫具有特殊的重要性,在美国专利No.5,468,253中对其作了介绍,在此引用参考其内容。本发明的一个目的是要将加强垫片60和61可释放地固定在手术钉合装置20的至少一部分上,其时间长达两年或更久。用热熔性胶粘剂固定加强垫片
图2-4示出了用本发明的固体胶粘剂65将加强垫片60和61可释放地分别固定到末端执行器35的第一和第二组织钳夹面46、41上的步骤。固体胶粘剂65在室温(25摄氏度)和体温(37摄氏度)下是固体,但在更高的温度下可以熔化。这种类型的胶粘剂被称作热熔性胶粘剂,在粘合过程中被用作熔化胶粘剂66。
熔化胶粘剂66在冷却时又回复为固体胶粘剂65而形成胶粘结合。在图2-4中,手术钉合装置20的末端执行器35被放大显示,而为了清楚起见,砧座40断开显示并作了旋转。
图2示出了用敷胶器70将熔化胶粘剂66涂敷到第一和第二钳夹面46、41上的第一个步骤。敷胶器70包括把手72、挤出熔化胶粘剂66的顶端管嘴71、装在把手72里面用来熔化固体胶粘剂65远端的电阻加热器75、敷胶器扳机73、以及电线74。将电线74连接到电源80上而接通电阻加热器75。把手72上带有靠近电阻加热器75的冷却槽77以防止过热。这类胶或胶粘剂用的敷胶器70在本技术领域中作为热熔胶枪为大家所熟知,而且很容易得到应用于工业或家庭。热熔胶枪或敷胶器70的一个出色实例是由IL 60084,Wauconda的FPL公司制造的SHURE BONDERPro 9000热熔胶枪。
在图2中,示出了一条固体胶粘剂65被插入近把手72端的孔中。当固体胶粘剂65棒条被插入时,它可操作地与一进料机构(未示出)接合,该进料机构可操作地连接到敷胶器扳机73上。操纵敷胶器扳机73使在把手中的固体胶粘剂65棒条向远侧移动直至接触到高温的电阻加热器75,从而使固体胶粘剂65棒条的远端部分熔化。继续在敷胶器扳机73上增大压力迫使熔化胶粘剂66从管嘴71的小孔76中挤出,并使固体胶粘剂65棒条朝着远侧移动到敷胶器70中。虽然热熔胶枪或敷胶器70是涂敷固体胶粘剂65的优选方法,但其它替代的敷胶器也可以使用。这些替代的敷胶器包括但不限于:加压熔化胶分配器,其可敷加一条熔化胶粘剂带;喷射器,用来施加喷出的熔化液滴;以及高温滚筒,可用来施加熔化胶粘剂薄膜。
在图2中,示出了用敷胶器70将若干行熔化胶粘剂66涂敷在砧座40和钉盒45的第一和第二组织钳夹面46、41上。熔化胶粘剂是在贴加强垫片60和61的步骤之前涂敷到这些表面上的。图中示出熔化胶粘剂66涂敷在第二组织钳夹面41上压出的钉坑42之间。第二组织钳夹面41上的这两行熔化胶粘剂66比较短,但能提供足够的保持力将第一加强垫片60固定在第二组织钳夹面41上,并且还使第一加强垫片60能够很容易地被移去。
图中示出在可更换钉盒45的第一钳夹面46上纵向排列的U形钉狭槽47之间布置有两排较长的熔化胶粘剂66。每个U形钉狭槽47中有一个活塞状的U形钉驱动器48(未示出),可从深入到可更换钉盒45里面的第一凹进位置移动到从第一组织钳夹面46伸出的第二位置。在图2和3中,U形钉驱动器48处于深入可更换钉盒45的U形钉狭槽47里面的第一凹进位置。每个U形钉狭槽47中安置有一个U形钉49(未示出),位于凹进的U形钉驱动器48上面。U形钉驱动器48移动到第二位置时将U形钉49从可更换钉盒45中射出。在这些附图中,U形钉驱动器48和U形钉49凹进在U形钉狭槽47的里面,不能看见。钉盒45以及U形钉驱动器48和U形钉49的移动在本技术领域中为大家所熟知,并可以在Williamson IV等人申请的美国专利5,415,334中找到,在此引用参考其内容。
如图3所示,在涂敷了熔化胶粘剂66之后,第二个步骤是将加强垫片60和61贴到相应的组织钳夹面46、41上。图中示出第一和第二加强垫片60和61朝第一和第二组织钳夹面46、41以及熔化胶粘剂66方向移动。图4示出了粘合过程的最后一个步骤,在此步骤中加强垫片60和61被放到适当的位置上,并被压紧在相应的钳夹面46、41上。当加强垫片60、61被压到适当的位置上时,熔化胶粘剂66在加强垫片60、61和钳夹面46、41之间被压缩,并冷却恢复为固体胶粘剂65,从而将加强垫片60、61固定到手术钉合装置20上。
手术钉合装置20发射时,使U形钉驱动器48从钉盒45里面的第一位置移动到从第一组织钳夹面46伸出的第二位置。这个动作同时使U形钉49升高并顶着砧座40而成形,并且向上提起第一加强垫片60使其离开钉盒45的第一组织钳夹面46。第一加强垫片60的向上移动使第一加强垫片60和第一组织钳夹面46之间的胶粘结合分开,从而使第一加强垫片60脱离钉盒45。
或者,通过将熔化胶粘剂66放到U形钉狭槽47中,然后将第一加强垫片60贴到钉盒45上,可以使加强垫片60粘附在钉盒45上。熔化胶粘剂可以以两种不同的方式放入U形钉狭槽47。第一种,可以用热熔粘合枪将热熔粘胶剂直接注入U形钉狭槽47中,然后将加强垫片60粘附到U形钉狭槽47上(未示出)。第二种,通过将熔化胶粘剂66放在第一组织钳夹面46上靠近U形钉狭槽47的地方(图3),然后把第一加强垫片60压紧到第一钳夹面46上将熔化胶粘剂66挤进U形钉狭槽47,可以使熔化胶粘剂66进入U形钉狭槽47中。挤压动作迫使大部分熔化胶粘剂66从第一组织钳夹面46进入到相邻的U形钉狭槽47中,因此可以将加强垫片60同时粘附到U形钉狭槽47和第一组织钳夹面46上(未示出)。如果固体胶粘剂65在U形钉狭槽47中,当手术钉合装置20发射时,U形钉驱动器48和U形钉49在U形钉狭槽47里面向上移动而接触到其中的固体胶粘剂65。与移动U形钉驱动器48和U形钉49的接触使固体胶粘剂65从狭槽47中被推出,从而分开第一加强垫片60和可更换钉盒45之间的胶粘结合。
因此,当通过手术钉合装置20的发射使钉盒45和第一加强垫片60之间的胶粘结合分开时,本发明的固体胶粘剂65成为一种可释放的胶粘剂。重要的是,应当注意到利用钉合装置20的发射来分开胶粘结合并不取决于粘胶剂的成分。即,有很多种胶粘剂可以按上述方法进行释放。除了热熔性胶粘剂之外,在室温下还可以使用其它胶粘剂包括如弹性化合物、室温硫化硅树脂、天然和人造橡胶、无氧化合物、密封胶、可模压化合物如牙科橡皮障、或有延伸性的材料如蜡。另外,上述胶粘剂或任何一种其它的胶粘剂如丙烯酸树酯、氰基丙烯酸酯、环氧树脂或类似的物质可以与粘结抑制剂一起使用。粘结抑制剂起到降低粘结强度的作用,可以包括油、油脂、蜡、脱模剂、特氟隆、硅树脂或其它任何可以妨碍粘结强度的表面杂质。
将U形钉49从可更换钉盒45射出还使得第二加强垫片61从第二组织钳夹面41上脱离,并使U形钉49变成B形的形状。U形钉49是通过钉入附着在第二组织钳夹面41上的第二加强垫片61并顶到砧座40中的钉坑42后而成为B形的形状。当U形钉49的钢丝压入钉坑42中时,U形钉钢丝的端部卷曲而成为B形,并使固体胶粘剂65从钉坑42和第二组织钳夹面41上脱离。这个动作使得第二加强垫片61从砧座40上分开(未示出)。
图5示出了用来将加强材料固定到圆形钉合器85上的熔化胶粘剂66。在用熔化胶粘剂66将加强衬环86粘贴到圆形压合表面88、87的步骤之前,所示加强衬环86与第一和第二圆形压合表面88、87是分开的。热熔性胶粘剂的组成成分
固体胶粘剂65可以是市场上能够买到的任何一种热熔性胶粘剂。热熔性胶粘剂最好是与人体组织生物相容的,并可以是天然或人造的。天然的生物聚合物,尤其是一些生物蛋白质可以被用作热熔性胶粘剂。这些蛋白质可以包括胶原蛋白、明胶、纤维蛋白、粘连蛋白、纤维蛋白原、弹性蛋白、血清白蛋白、血红蛋白、卵清蛋白等类似的物质及其任何组合物。另外,多糖如透明质酸、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、聚乙酰氨基葡萄糖/聚氨基葡萄糖、琼脂糖和藻酸盐也可以单独使用或与其它材料结合起来使用。
人造材料可以包括聚(乳酸)、聚(乙醇酸)、聚(羟基丁酸)、聚(膦嗪)、聚酯、聚乙二醇、聚环氧乙烷、聚丙烯酰胺、聚羟乙基异丁烯酸盐、聚乙烯吡硌烷酮、聚乙烯醇、聚丙烯酸、多醋酸盐、聚己酸内酯、聚丙烯、尼龙等类似的物质。
固体胶粘剂65所具有的特殊重要性是它在大体上低于40摄氏度的温度下是一种固体共聚物。优选的共聚物是ε-己内酯或碳酸环丙烷与乙交酯的共聚物。这种共聚物最好是ε-己内酯与乙交酯的共聚物。ε-己内酯的数量可以是在重量百分数的30与45之间,其余为乙交酯。理想的是,这种共聚物可以由36∶64(摩尔/摩尔)的ε-己内酯和乙交酯组成。这种共聚物在用质子核磁共振光谱法测定时是一种包含未反应单体少于百分之一的弹性体。在25摄氏度下用0.1克/分升的六氟异丙醇(HFIP)溶液来测定该共聚物的特性粘度,其范围可以从大约0.8克/分升至大约3.2克/分升,最好是从大约0.8克/分升至大约2.4克/分升,在大约1.6克/分升就更好。在一个经特别优选的实施例中,优选固体胶粘剂和优选加强材料都可以由同一种能生物吸收的材料ε-己内酯乙交酯制成。
固体胶粘剂65的特性在于当温度达到40摄氏度之前是固体,而在40.1摄氏度至600摄氏度之间的更高温度下熔化但不会降解。更可取的是,固体胶粘剂65在120摄氏度至240摄氏度之间、最好是在180摄氏度的高温下熔化而不降解。上述共聚物可以根据美国专利号5,468,253、5,133,739和4,605,730中所提供的说明来制备,在此引用参考这些专利的内容。将加强垫片固定到砧座上的另一种装置和方法
图6-10示出了将加强垫片固定到图1所示手术钉合装置20的砧座40上的另一种装置和方法。图6示出了砧座40上固定有砧座滑套90的手术钉合装置20,其中加强垫片可拆卸地固定在砧座滑套90上。砧座滑套90砧座40上滑移,当完全装配好时锁定在砧座40上。可以很容易地松开这种锁定状态以拆卸或更换砧座滑套90。
如图7-9中清楚所示,砧座滑套90是由框架或滑套外壳91与带孔加强垫片100组装而成的。滑套外壳91是空心的,可以套到砧座40上,并带有倒U字形的滑套主体92和从那里向远侧延伸的鼻端95。鼻端95可以是圆头的或不致损伤的以防止在将手术钉合装置20放入到手术部位的过程中造成组织损伤。弹簧部件96将鼻端95连接到滑套主体92的顶端上。锁扣或固定部件97位于鼻端95的内表面(未示出)上,使砧座滑套90与手术钉合装置20的砧座40可释放地接合。固定部件97可以是凸块或突肋,能与手术钉合装置20的砧座40上的凹进配对部件(未示出)相啮合。提起鼻端95离开砧座40(当固定部件97与砧座40相啮合时)会使弹簧部件96发生偏斜,使得固定部件97脱离砧座40上的凹进配对部件,从而将滑套外壳从砧座40上松开。若干连接部件如L形的卡钩93从滑套主体92的每一侧向下延伸,其臂部94从L形卡钩93的垂直部分或第一部分93a向远侧水平延伸。虽然优选实施例中使用的是卡钩93,但是销钉、支臂、突舌、凸台或任何一种能释放的机构都可以加入滑套外壳91中。滑套外壳91可以用刚性或半刚性的材料如工程塑料制成,比如还可以包括液晶聚合物、聚碳酸酯、聚苯乙烯、或任何一种适当的医学级工程热成形塑料或热固塑料。另外,滑套外壳91还可以用任何一种金属材料如铝、钢、不锈钢、铜、或其化合物及合金制成。
带孔加强垫片100是用上述加强材料中的任何一种制成的矩形薄片,并带有两排彼此隔开的穿孔101。通过将每个水平臂部94完全拧入带孔加强垫片100中相应的各个孔101里面,直至孔101与L形卡钩93的第一部分93a或垂直部分相接触,使带孔加强垫片100固定在滑套外壳91上。当带孔加强垫片100相对于滑套外壳91向远侧移动时,使孔101离开臂部94,从而使带孔加强垫片100脱离滑套外壳91。因此,通过沿一个方向的直线运动可以将带孔加强垫片100从滑套外壳91中拆卸下来。图7中的箭头示出了把带孔加强垫片100螺纹连接在臂部94上时孔101的移动路径。
图8是等轴视图,示出了带孔加强垫片100与滑套外壳91的优选组件。在这个组件中,可以看到每一个卡钩93的臂部94都位于带孔加强垫片100中相应的孔100里面。当臂部94与孔101组装在一起时,带孔加强垫片100的边缘会由于臂部94放入孔101中而产生轻微的凹陷。当砧座滑套90的这种优选组合件安装到砧座40上时,带孔加强垫片100会被砧座40的第二钳夹面41向外绷紧,从而使带孔加强垫片100变平。
图9是带孔加强垫片100与滑套外壳91的另一种组件的横断面视图。在该图中,带孔加强垫片100的边缘沿每一排孔101向上弯折而成为大体上是U形的形状。接着将U形带孔加强垫片100的垂直侧面放到卡钩93的内侧,并使每个臂部94都穿入与其相应的孔洞101中。这种连接方法可以使所固定的带孔加强垫片100具有大体上平直的水平部分。
在手术过程中,砧座滑套90是按照下述方法来使用的。将砧座滑套90(包含带孔加强垫片100)套到手术钉合装置20中打开的砧座40上。接着,关闭砧座40并将手术钉合装置20的末端执行器35插入病人身体中。在选定的手术部位将砧座40打开并将末端执行器放在组织上。然后关闭砧座40以夹住位于砧座40的第二钳夹面41与可更换钉盒45的第一钳夹面46之间的组织。发射手术钉合装置20,将带孔加强垫片100钉合在组织上,接着切割钉合线之间的组织和加强垫片。打开砧座40,将手术钉合装置20从手术部位上抽回。当抽出手术钉合装置20时,被钉住的带孔加强垫片100保留在组织上,而滑套外壳91的臂部94从带孔加强垫片100的孔101中滑出,使带孔加强垫片100脱离手术钉合装置20。要在手术钉合装置20中重新装入一个没有用过的砧座滑套90时,外科医生必须将手术钉合装置20从病人身体中取出。接着,通过提起鼻端95将固定部件97从砧座40上松开,然后滑动滑套外壳91使其脱离砧座40,外科医生可以将用过的滑套外壳91从砧座40上取下。把一个没有用过的砧座滑套90套在砧座40上后就完成了重新装入的过程。
图10示出了可更换滑套外壳191的另一个实施例,在手术过程中它可以同时从砧座40和带孔加强垫片100上分开,使带孔加强垫片100脱离手术钉合装置20。可更换滑套外壳191包括长条形的滑套主体192、带有臂部194和从那里伸出的第一部分193a的卡钩193、以及鼻端195。扁尾198从滑套外壳191的近端延伸出来,并有一长缝合线或绳索199牢固地连接在扁尾198上。可以用前面所述并在图8和9中示出的任何一种方法将带孔加强垫片100与可更换滑套外壳191装配在一起。
在手术过程中,将装有带孔加强垫片100的可更换滑套外壳191套在末端执行器35的砧座40上。接着使绳索199从可更换滑套外壳191沿轴30向近端延伸,其自由端靠近手术钉合装置20的把手25。将末端执行器35放入病人身体中(通过套管针),使绳索199的自由端留在病人身体的外面。在用末端执行器35钳夹在组织上并发射手术钉合装置20后,用力拉动绳索199使带孔加强垫片100从手术钉合装置20上松开。拉动绳索199同时还使可更换滑套外壳191向近身侧移动而与砧座40分开。当可更换滑套外壳191向近身侧移动时,臂部194从带孔加强垫片100的孔洞101中拔出,使带孔加强垫片100脱离可更换滑套外壳191和砧座40。打开砧座40使带孔加强垫片100和被固定的组织从末端执行器35上松开。接着通过套管针用绳索199将用过的可更换滑套外壳191从病人身体中拉出。
图11示出了将带孔加强垫片可拆卸地固定到一钉合装置即圆形钉合器85上的又一个实施例。在这个实施例中,加强垫片是通过旋转运动而不是前面所述的直线运动从圆形钉合装置上松开的。如图所示,圆形钉合器85包括打开的圆形砧座89和纵轴。连接环105固定在圆形砧座89上或是由圆形砧座89形成。突舌卡钩106从连接环105向仪器主体侧延伸并带有突舌支臂106a。突舌支臂106a在圆形砧座89的圆周上全部沿反时针方向从突舌卡钩106上延伸出来。突舌卡钩106沿半径方向布置在外面,所以圆形砧座89可以完全闭合而不会压坏突舌卡钩106。
带孔加强垫圈107安装在从圆形砧座89延伸出来的突舌卡钩106上。若干突舌108彼此隔开布置在带孔加强垫圈107的周围,每个突舌108带有从中贯穿的突舌孔洞109。如图所示,有四个突舌108等间隔布置在带孔加强垫圈107的周围,突舌卡钩106的数目与此相同。为了将带孔加强垫圈107可拆卸地固定到连接环105的突舌卡钩106上,应将突舌孔洞109放在突舌支臂106a上并沿顺时针方向旋转带孔加强垫圈107。同样地,沿反时针方向旋转将松开已固定的带孔加强垫圈107。或者,突舌支臂106a可以沿顺时针方向延伸,在这种情况下,安装时应沿反时针方向旋转带孔加强垫圈107,拆卸时应沿顺时针方向旋转带孔加强垫圈107。在将带孔加强垫圈107钉合在组织上之后,打开圆形砧座89并沿顺时针方向转动圆形钉合器85使支臂106a从突舌孔洞中退出,从而使带孔加强垫圈107脱离圆形钉合器85。由于圆形钉合器85是一种单发射的仪器,所以连接环105可以永久性地或可拆卸地固定在圆形砧座89上。另一方面,通过在第二圆形压合表面87旁加上另一个连接环105可以使带孔加强垫圈107固定在第二圆形压合表面87上,其中该连接环105上的突舌卡钩106向远侧延伸(未示出)。如果第一和第二圆形压合表面88、87旁都安装有连接环105,必须注意确定两组连接环卡钩106的方位以避免在关闭时互相接触,且两个连接环105上的支臂106a应沿相同的方向延伸(未示出)。当支臂106a的延伸方向相同时,转动圆形钉合器85可以同时松开两个带孔加强垫圈107。
虽然已经图示和说明了本发明的一些具体实施例,但是在不违背本发明精神和范围的情况下可以对所述装置和/或方法进行修改。用于说明本发明的术语只是说明性的而非限制性的。
Claims (10)
1.一种用来钳夹和钉合人体组织的手术钉合装置,包括:
a.把手,连接在所述把手上并可在开启位置和关闭位置之间活动的相对的第一和第二组织钳夹件,当处于所述开启位置时可容纳在它们之间的组织,而当处于所述关闭位置时可钉合在它们之间的组织,所述第一和第二钳夹件中的至少一个装有若干U形钉;和
b.用热熔性胶粘剂可释放地连接在所述第一和第二组织钳夹件中至少一个上的加强材料垫片,所述加强材料布置在所述钳夹件上,因此所述U形钉可以将所述加强材料连接到所述钳夹件之间的组织上。
2.根据权利要求1所述的手术钉合装置,其特征在于,所述热熔性胶粘剂在低于40摄氏度时是固体。
3.根据权利要求1所述的手术钉合装置,其特征在于,所述热熔性胶粘剂的粘度在大约0.6克/分升至2.5克/分升之间。
4.根据权利要求1所述的手术钉合装置,其特征在于,所述热熔性胶粘剂的粘度在大约1.3克/分升至1.8克/分升之间。
5.根据权利要求1所述的手术钉合装置,其特征在于,所述热熔性胶粘剂是一种共聚物,其中ε-己内酯的重量百分数大约在30至45之间,其余为乙交酯。
6.根据权利要求1所述的手术钉合装置,其特征在于,所述热熔性胶粘剂最好是一种共聚物,其中ε-己内酯的重量百分数大约为36,其余为乙交酯。
7.根据权利要求1所述的手术钉合装置,其特征在于,所述加强材料是ε-己内酯乙交酯。
8.根据权利要求1所述的手术钉合装置,还包括一可更换钉盒,用来将所述若干U形钉布置在所述第一和第二钳夹件的至少一个上面。
9.一种用来钳夹和钉合人体组织的手术钉合装置,包括:
a.把手,连接在所述把手上并可在开启位置和关闭位置之间活动的相对的第一和第二组织钳夹件,当处于所述开启位置时可容纳在它们之间的组织,当处于所述关闭位置时可钉合在它们之间的组织,所述第一钳夹件包括沿基本平行的两个分隔开的行布置在其中的若干U形钉,所述第二钳夹件包括用来使所述U形钉成形的砧座;和
b.用布置在所述至少一个钳夹件的钉坑里面的胶粘剂可释放地连接在所述第一和第二组织钳夹件中至少一个上的加强材料垫片,所述加强材料设置在所述钳夹件上,因此所述U形钉可以将所述加强材料固定到位于所述钳夹件之间的组织上。
c.安装在所述把手上的一刀片,所述刀片可以在所述两行U形钉之间滑动,用以切割其中的组织和加强材料。
10.一种可安装到手术钉合装置的末端执行器中的钉盒,所述钉盒包括:
a.装有若干U形钉的部件,所述部件包括可将其本身可释放地固定到手术器械上的机构;和
b.用热熔性胶粘剂可释放地固定在所述部件上的加强材料垫片。
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US09/850,374 US6656193B2 (en) | 2001-05-07 | 2001-05-07 | Device for attachment of buttress material to a surgical fastening device |
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