CN1166992A - 分岔式移植片固定模及其制造方法 - Google Patents

分岔式移植片固定模及其制造方法 Download PDF

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CN1166992A
CN1166992A CN97110842A CN97110842A CN1166992A CN 1166992 A CN1166992 A CN 1166992A CN 97110842 A CN97110842 A CN 97110842A CN 97110842 A CN97110842 A CN 97110842A CN 1166992 A CN1166992 A CN 1166992A
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雅各布·里克特
格雷戈里·平查希科
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Abstract

用来插入分岔器管如血管内的分岔移植片固定模。在第一实施例中，将第一片件形成第一支干，第二片件形成第二支干，第三片件形成主干，而将两支干接附于主干上。在第二实施例中，第一片件形成具有第一支干和一半主干的管件，第二片件形成具有第二支干和一半主干的管件，主干的这两个一半部分便组合形成分岔式移植固定模。在第三实施例中，此分岔式移植片固定模包括两段，它们在待治疗的分岔器管的病灶内依序插入并装配于相应器管中。

Description

分岔式移植片固定模及其制造方法
本发明涉及分岔式移植片固定模(bifurcatecl stents)以及制造这种用于插入体内支管中的移植片固定模的方法。
移植片固定模在有关技术领域中属周知的。它们一般是由在内部加压时可伸展开的柱形金属网制成。或者，它们也可由金属丝绕成柱形或由片状料来形成柱形。
所谓移植片固定模乃是这样的器件，它们通常植入身体的各种管道，包括血管系统内，用来增强血管的塌缩的、部分堵塞的、弱化的或异常膨胀的部分。移植片固定模已成功地植入其它部位，例如泌尿道或胆管内以加强这类体内管道。
美国专利4994071号(MacGregor)公开了一种可伸展的分岔式移植片固定模，它具有由互连的韧性件形成的主体柱形网格结构。还构制了另外两个直径较主网格结构小的类似的附设的柱形网格结构。此主网格结构包括有韧性的金属丝将主网格结构与另外两个网格结构之一互连；还包括有韧性的第二金属丝用来将主网格结构与附设的这两个网格结构中的另一互连。上述这两根韧性金属丝形成了主干件，它们沿着主网格结构和各个附设网格结构的长度轴向延伸。这种分岔式移植片固定模的缺点之一是，形成主干件的韧性金属丝与各网格结构中的环形构件的互连本质上就是很复杂的。
本发明通过提供分岔式移植片固定模及其制法，同时采用具有主干和两个支干的分岔式移植片固定模而克服上先有技术中上述的和其它的缺点。
在本发明的第一实施例中，于制造分岔式移植片固定模时提供了三个具有所需图案的片件，其中两个片件的尺寸基本相同而第三个片件则较前两个片件中任何一个都宽。每个片件都通过将其两纵边卷合到一起焊合成接缝而形成管件。较大的片件形成的管用作分岔式移植片固定模的主干，而另两个片件所形成的管则用作此分岔式移植片固定模的支干。这两个支干然后结合到主干上形成分岔式移植片固定模。
在本发明的第二实施例中，是通过制备两个用于移植片固定模的片件来形成分岔式移植片固定模的。在各个片件中是将此片件一部分的两纵边卷合并相互固定而形成分岔式移植片固定模的两支干之一。而各个片件的余剩的自由纵边然后接合形成此移植片固定模的主干。
在第三实施例中，分岔式移植片固定模包括第一和第二管状部。第一管状部具有形成分岔式移植片固定模主干的近端和形成此固定模两支干之一的远端。在此第一管状部的近端与远端之间设有一个支孔。第二管状部引入到第一管状部主干部的纵向孔中并推进通过上述支孔，突出到此支孔之外而形成另一支干即第二支干。当所述第二管状部伸展开时，此第二管状部的近端便同界定前述支孔的材料相结合，而将前述第二支干固定于所需位置处。
本发明的目的之一在于提供一种制造分岔式移植片固定模的方法，此方法包括下述步骤：a)制备好具有第一边、第二边、第三边和第四边的第一片件；b)制备好具有第一边、第二边、第三边和第四边的第二片件；c)制备好具有第一边、第二边、第三边和第四边的第三片件；d)将第一片件的第二边接附到第三边上，形成具有近端与远端的第一管状支干；e)将第二片件的第二边接附到第三边上，形成具有近端与远端的第二管状支干；f)将第三片件的第二边接附到第三边上，形成具有近端与远端的管状主干；以及g)将第一支干的近端和第二支干的近端接附到此主干的远端上。
本发明的另一个目的在于提供一种制造分岔式移植片固定模的方法，此方法包括下列步骤：a)制备好具有近端与远端的第一片件；使此第一片件的远端变形形成第一支干，同时使此第一片件的近端变形形成主杆的第一个一半；c)制备好具有近端与远端的第二片件；d)将第二片件的远端变形形成第二支干，同时将第二片件的近端变形成主干的第二个一半；以及e)接合此主干的第一个一半和主干的第二个一半来形成主干。
本发明再有一个目的在于提供一种制造分岔式移植片固定模的方法，此方法包括下述步骤：a)制备好具有近端与远端以及一贯通的纵向孔的第一可伸展管件，此第一管件在其上述近端与远端间设有一个支孔，此支孔与所述纵向孔通连，支孔的大小则适合于纳置和固定一第二可伸展管件；b)将此第一可伸展管件输送到具有第一内腔和和二内腔的体内管道，使得此第一可伸展管件位于第一内腔中，而此支孔则与第二内腔通连；c)将此第一可伸展管件伸展到足以将其自身固定于第一内腔中的程度；d)制备好具有近端与远端以及一贯通的纵向孔的第二可伸展管件；e)扩张上述支孔；f)将此第二可伸展管件输送到上述支孔内，使得此第二可伸展管件的远端位于第二内腔中，而此第二可伸展管件的近端则位于所述第一管件的纵向孔内；以及g)使此第二可伸展管件伸展到足以将其自身固定于第二内腔中以及位于所述支孔内的程度。
图1示明依据本发明所制的分岔式移植片固定模；
图2示明形成图1所示移植片固定模的支干与主干时所用的片件；
图3示明图2中所示片件已卷成管状后的形状；
图4是图3所示管件在组装前的透视图；
图5是图3与4中所示管件在已组装成移植片固定模后的端视图；
图6是图5所示组装好的分岔式移植片固定模的顶视图；
图7示明形成依据本发明所制的分岔式移植片固定模另一实施例中所用的片件；
图7B示明形成依据本发明所制分岔式移植片固定模另一实施例时所用的片件；
图8示明具有分界点的图7中的片件；
图9示明图8中的片件已卷合成管状的情形；
图9B示明图7B中的片件已卷合成管状的情形；
图10示明正要组装前的图9中的管件；
图10B示明正要组装前的图9B中的管件；
图11是图9与10所示管件组装后的侧视图；
图11B是图9B与10B中所示管件组装后的侧视图；
图12是图12所示已组装好的分岔式移植片固定模的端视图；
图12B是图11B所示已组装好的分岔式移植片固定模的端视图；
图12C示明可用来置换图7与7B中所构型的另一种构型的实施例；
图13示明用来形成依据本发明所制分岔式移植模另一实施例的主干以及第一支干和第二支干。
图14示明设在待治疗的主干内腔和支管内腔中的导引金属丝；
图15示明设在导液管与导引金属丝之上于引入到待处理的内腔中的，图7所示的主干与第一支干；
图16示明已输送到待处理的体内分岔器件的并在前伸展开之前的，图13中所示主干与第一支干；
图17示明已伸展开后的图16所示的第二支干；
图18示明支孔扩展开的情形；
图19示明设于支孔内的未伸展开的第二支干；
图20示明图19中所示第二支干的伸展开的情形；而
图21示明设置在待处理的分岔内腔中的已组装好的分岔式移植片固定模。
在图1所示实施例中，分岔式移植片固定模包括第一支干10、第二支干15和主干20。图2示明了用来形成第一支干10的第一片件25、用来形成第二支干15的第二片件30、以及用来形成主干20的第三片件35。第一片件25和第二片件30基本上是扁平状的，具有预定的长与宽尺寸。为能用于许多方面，第一片件25和第二片件30所具的尺寸基本相同，但是支干10和15以及用来生产它们的片件25和30则可根据具体的应用条件而有不同的尺寸。本发明的移植片固定模的尺寸可确定成，使其在组装后能实现在最佳实施例中的最终尺寸，这样的移植片固定模可以伸展，而其大小适合在伸展后来取得其最终尺寸。移植片固定模的片件70与75可图案化或侵蚀成具有许多孔眼，可根据具体的应用需要实现如前讨论中所需的可伸展特点。第一片件25具有第一边26、第二边27、第三边28和第四边29。第二片件具有第一边31、第二边32、第三边33和第四边34。第三片件具有第一边36、第二边37、第三边38和第四边39。在从金属片上裁切下形成片件25、30与35后，它们受到变形与卷合处理，使其两个相对的边会合而形成柱形。在图2与3所示例子中，边27与边29通过焊缝14结合成第一支干10。边32与边34通过焊缝19形成第二支干15。边37与边39通过焊缝29形成主干20。上述各边可以通过本项技术中适用于此处目的的多种方式结合，例如用螺钉结合、卷边咬合、钎焊接合，组在最佳实施例中采用的是焊合。如图3所示，第一支干10具有近端11、远端12并界定出一纵向孔13。第二支干15有近端16、远端17并界定出一纵向孔18。主干20则有近端26、远端27同时界定出一纵向孔28。图4示明了在将要组装前的第一支干10、第二支干15和主干20。为了形成分岔式移植片固定模。是将第一支干10的近端11和第二支干15的近端16结合主干20的远端27，使得纵向孔13、18与28相互连通。图5和图6分别是已组装好的分岔式移植片固定模的端视图和侧视图。
图11是依据本发明所制分岔式移植片固定模的第二实施例。此移植片固定模50设有接附于主干65上的第一支干55和第二支干60。分岔式移植片固定模50是由图7所示的第一片件70与第二片件75形成。这种移植片固定模用的片件70与75可以构型成或腐蚀出许多孔眼，根据具体应用要求形成种种图案以适应前面论述中所要求的可展伸特点。片件70与75基本上是扁平的并具有预定的长度与宽度。第一片件70具有第一边71、第二边72、第三边73和第四边74。第二片件75具有第一边76、第二边77、第三边78与第四边79。为了形成移植片固定模的支干，将边72的一部分卷向边74的一部分同时将边77的一部分卷向边79的一部分。如图8所示，在片件70与75上选定分界点80、81、82与83。这些分界点80、81、82与83。这些分界点80、81、82与83的选择要满足具体应用的要求，并可以根据支干55和60以及主干65这三者各自所需的长度来调整。分界点80与81相对于边73与71等距，分界点82与83相对边76与78等距，这样就会使所形成的移植片固定模中的支干55和60所具有的长度基本上与主干65的长度相等，要是将分界点选择相对于边73与78来说更接近边71和76，则各支干60与65的长度将大于主干65的长度。在一最佳实施例中，分界点80、81、82与83经选定成使得近边72”、74”、77”和79”的长度约为边72、74、77与79长度的1/3。如图8所示，分界点81将边74在其大致的中点处分成远边74’与近边74”。分界点82则将边77在其大致的中点处分成远边77’与近边77”，而分界点83则将边79在其大致中点处分成远边79’与近边79”。
为了形成移植片固定模，将边72’通过焊缝90与边74’结合而形成具有第一支干55和主干的第一个一半65。边77’通过焊缝91与边79’结合而形成具有第二支干60和主干的第二个一半65”。如前所述，这些边要以用本项技术中众多的周知方式结合。图10示明了在即将组装前对准好的图9中所示的第一管件95和第二管件100。为了制造图11和12中所示分岔式移植片固定模，是将边72”通过焊缝92与边79”结合，并使边74”通过焊缝93与边74”结合，而使得主干的第一个一半65’和第二个一半65”形成主干65。图12是图11所示移植片固定模的横剖端视图。
在图7所示实施例中，片件70与75是方形或矩形。但片件70与75并不限于上述构型，而是可取例如图7B中所示的这种构型。图11B示明采用图7B中所示的片件270与275制得的分岔式移植片固定模250。此移植片固定模250设有接附于主干265上的第一支干255和第二支干260。分岔式移植片固定模250是由图7B所示的第一片件270和第二片件275构成。片件270与275可以按以前所述设定其相对尺寸并进行腐蚀处理的。如图7B所示。第一片件270具有第一边271、第二边272、第三边273、第四边274、第五边275、第六边276、第七边146与第八边147。第二片件275具有第一边277、第二边278、第三边279、第四边280、第五边281、第六边282、第七边148与第八边149。如图9B所示，边274通过焊缝290与边276结合成具有第一支干255和主干第一个一半265’。边280通过焊缝291与边282结合成具有第二支干260和主干第二个一半265”。如前述，上述这些边可以用本项技术中周知的多种方式结合。图10B表明图9B中所示第一管件295和第二管件300在即将组装前相对准的情形。为了制造图11B与图12B中所示的分岔式移植片固定模250，将边272通过焊缝292与边149结合，同时将边278通过焊缝293与边147结合，使得主干的第一个一半265’和第二个一半265’形成主干265。图12B是图11B所示移植片固定模的横剖端视图。图12C示明了可用于置换图7与7B中所示构型的另一种构型。
本发明的第三实施例包括两个部分，它们依两个步骤顺次地使用而组装到病人体内，由此来形成分岔式移植片固定模。图13示明的主干和第一支干110设有一纵向孔131，同时具有确定出支干125的近端115和确定出第一支干130的远端120。第二支干140设有纵向孔132并且有近端145和远端150。此主干与第一支干110和等二支干140可以按照以前所述设定其相对尺寸并进行图案化或腐蚀处理。在主干与第一支干110的近端115和远端120之间设有支孔135。支孔135的尺寸选定成能置纳下第二支干140，并在此支干于支孔135内伸展开时能与支干140配合且将其固定。第二支干140的尺寸设定成在其伸展时能配合并固定于支孔135内。图14至21示明如何将这种分岔式移植片固定模装配到分岔的内腔中。如图14至21所示，待治疗的范围是具有第一或主干内腔190和第二或分支内腔195的分岔内腔。如图14所示，将第一导引金属丝155引入到主干内腔190内，同时将第二导引金属丝156引入到分支内腔195中。如图15所示，将一可由气囊伸展的主干和第一支干110设置于第一带气囊导液管170的梢部上，而使气囊175位于纵向孔131内。然后将第二带气囊导液管171引入到主干和第一支干110的纵向孔131内，并向前推进而使气囊176设置于支孔135内。第一导液管170安装于第一导引金属丝155上，而第二导液管171则安装于第二导引金属丝156上。如图16所示，非伸展开的主干与第一支干110被导引到待治疗的范围，使得第一支干130位于主干内腔190内，而支孔135则同分支内腔195通连。导液管与气囊都是传统类型的而未按比例给出，为简明起见略去了它们的属周知的细节。使气囊175充气即可使主干与第一支干110伸展如17所示，固定于所述位置。伸展开后，主干和第一支干110的外壁便会同主干内腔190的内壁接触，但为醒目起见有意识地留有一间隙。第一导液管170上的气囊175保持于充气状态，然后给第二导液管171上的气囊176充气而将支孔135扩大，如图18所示。随着支孔135的扩大，界定出支孔135的部分移植片固定模便被外推而形成一分支定位唇180。
使气囊175与176放气减压，撤出第二导液管171而将第二导引金属丝156保留于分支内腔195中。然后把第二支干140作用到第二导液管171上，使得第一气囊176位于纵向孔132内，然后使第二导液管171作用于第二导向金属丝156上。此时，第二支干140即被导向和引入到主干与第一支干110的纵向孔131内，并被推进而通过支孔135，使得第二支干140的远端突入到分支内腔195中而近端145则与纵向孔131通连，如图19所示，使第二导液管171上的气囊176部分地充气，然后使第一导液管170上的气囊175部分地充气至一与气囊176中的压力基本相等的压力。再让这两个气囊175与176同时充气至基本上具有相同的压力。如图20所示，第二导液管171上气囊176的膨胀促致第二支干140伸展开致其外壁配合并固定到环绕支孔135的区域上。第一导液管170上气囊175的充气防止了在气囊176充气时主干与第一支干110的塌缩。当伸展开后，第二支干140的外壁便同内腔195的内壁触合，但为明白起见，有意地留有一间隙。令气囊175与176放气，撤出导液管170与171以及金属导引丝155与116，而后组装好的分岔式移植片固定模便留定于适当的位置上。

Claims (3)

1.制造分岔式移植片固定模的方法，此方法包括下述步骤：a)制备好具有第一边、第二边、第三边和第四边的第一片件；b)制备好具有第一边、第二边、第三边和第四边的第二片件；c)制备好具有第一边、第二边、第三边和第四边的第三片件；d)将第一片件的第二边接附到第三边上，形成具有近端与远端的第一管状支干；e)将第二片件的第二边接附到第三边上，形成具有近端与远端的第二管状支干；f)将第三片中的第二边接附到第三边上，形成具有近端与远端的管状主干；以及g)将第一支干的近端和第二支干的近端接附到此主干的远端上。
2.制造分岔式移植片固定模的方法，此方法包括下述步骤：a)制备好具有近端与远端的第一片件；使此第一片件的远端变形形成第一支干，同时使此第一片件的近端变形形成主干的第一个一半；c)制备好具有近端与远端的第二片件；d)将第二片件的远端变形形成第二支干，同时将第二片件的近端变形成主干的第二个一半；以及e)接合此主干的第一个一半和主干的第二个一半来形成主干。
3.制造分岔式移植片固定模的方法，此方法包括下述步骤：a)制备好具有近端与远端以及一贯通的纵向孔的第一可伸展管件，此第一管件在其上述近端与远端间设有一个支孔，此支孔与所述纵向孔通连，支孔的大小则适合于纳置和固定一第二可伸展管件；b)将此第一可伸展管件输送到具有第一内腔和第二内腔的体内管道，使得此第一可伸展管件位于第一内腔中，而此支孔则与第二内腔通连；c)将此第一可伸展管件伸展到足以将其自身固定于第一内腔中的程度；d)制备好具有近端与远端以及一贯通的纵向孔的第二可伸展管件；e)扩张上述支孔；f)将此第二可伸展管件输送到上述支孔内，使得此第二可伸展管件的远端位于第二内腔中，而此第二可伸展管件的近端则位于所述第一管件的纵向孔内；以及g)使此第二可伸展管件伸展到足以将其自身固定于第二内腔中以及位于所述支孔内的程度。
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