CN1462181A - 一种把器件插在心房附件中的装置 - Google Patents

一种把器件插在心房附件中的装置 Download PDF

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CN1462181A
CN1462181A CN01816056.5A CN01816056A CN1462181A CN 1462181 A CN1462181 A CN 1462181A CN 01816056 A CN01816056 A CN 01816056A CN 1462181 A CN1462181 A CN 1462181A
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托马斯·E·博里略
格雷格·S·萨顿
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Abstract

把器件放在心房附件中的传送系统，包括导管插入装置，有一个管结构，具有座入的管、丝和轴。管建立了器件穿过人体脉管和心脏到心脏附件的通道。可膨胀的定位管设在通过装置的管的远端。定位管可就地膨胀以接合接近心脏附件的心房壁表面的机械稳定器件的传送通道。穿过管的轴把器件通过通道传到心房附件。该系统包括对于器件横过中隔传送的导管插入装置。外管或套管用来刺穿及横过中隔。可膨胀的固定装置设成朝着套管的一端。固定装置就地膨胀以接合被横过的中隔的表面部分进一步限制横过中隔的套管的偶然的运动。

Description

一种把器件插在心房附件中的装置
发明的背景
技术领域
本发明涉及把器件插在心房附件中的装置。该器件可用来过滤或修改在心房附件和心脏的相关的心房之间的血流以防止血栓从心房附件逸到人体的血流系统中。更具体地，本发明涉及经皮的传递和插入这种器件的装置。
现有技术的说明
有多种心脏病(如冠状动脉病)对病人的心脏有各种有害的影响。某些心脏病的有害影响(如二尖瓣病)是心房纤维性颤动。心房纤维性颤动导致降低贲门输出。高的血栓栓塞的发病率配合有心房纤维性颤动，左心房附件(LAA)常是血栓(粒子组合)的源。
左心房中形成的血栓是由于在纤维性颤动和不适当的左心房附近的放空。在心房附件中的贫血导致生成血栓。血栓可累积和自身聚积。大或小的血栓片可从心房附件断开和扩展到心房。血栓片可进入人体血流中和阻塞血流。
血栓片从心房附件进入人体的血流中的移动导致严重的医药上的问题。血从左心房和心室循环到心肌、脑、和其它组织，供给氧气和其它的营养。在左心房附件中形成的血栓产生的栓子会阻塞动脉，血通过动脉流入人体器管。阻塞影响器管组织正常的血流和氧的供应(局部缺血)，和根据涉及的人体器管导致局部缺血的事件，如心脏病(心肌局部缺血)和中风(脑组织局部缺血)。
重要的是处理心脏病患者的状态以防止已在心房附件形成的血栓产生的碎片或栓子通过血流扩展到心肌、脑、或人体的其它器官。
现时一些处理方法指向把塞形装置插入在心房附件中以阻止血流的通过。
避免血栓栓塞事件(例如心脏病、中风或其它的局部缺血事件)的预防处理方法包括过滤流出心脏附件的血流中有害的栓子。这些共同悬而未决及共同拥有的专利申请包括：
US专利申请  09/408,008号，
US专利申请  09/614,091号，
US专利申请  09/642,291号，
US专利申请  09/697,628号，
US专利申请  09/932,512号。
上述这些文件作为本申请的参考，这些文件说明了可膨胀的过滤装置，该装置可插在心房附件中以过滤血流。
在紧凑状态的插入器件可使用普通的导管插入装置就地传送到心房附件。使用一般的成像技术(如X射线、回声心动描记器)，可观察植入器件的位置。通过就地膨胀，插入器件可以展开。通过就地膨胀可展开植入器件。膨胀结构与周围的心房附件组织接合可固定住植入器件。可膨胀的结构可包括组织刺穿锚定。
为有效作用，器件必须在心房附件内或心房附件附近的合适位置展开。例如，器件的过滤元件必需正确地对中，或位于穿过心房附件的口，以便元适合适拦截及过滤心房附件流出的血液。把一个器件放在合适的展开位置要求位置探测或从原始的传送位置的调节。
因此要求提供一种导管插入装置，具有位置导向件可以控制位置探测和对起先的传送入的插入装置位置的重调整以把装置放在心房附件中的合适的展开位置中。
另外，插入程序可包括横过中隔的导管插入，该导管插入包括刺穿心房中隔和把通道套管传送通过中隔。通道套管提供了一个管道，通过该管道，植入器件可被传送穿过中隔进入连接的心房中。在导管插入过程中套管的偶然的运动会导致不希望的医学的并发症。例如，反向的滑动会导致套管与中隔脱开，这就要求反复地刺穿和穿过中隔，再得到到连接的心房的通路。另外，通道套管的位置或方向的不稳定性使传送装置放在附件中有困难。
因此，要求提供一种横过中隔的导管插入装置，其包括固定装置，以限制横过中隔的通道套管的运动和固定其位置。
发明内容
本发明提供了一种导管插入装置，具有一个定位装置或导向件，允许控制位置探测和重调整原始的传送入的植入器件的位置。导管插入装置可包括一根或多根座入的管、丝或轴。定位导向件可连接到穿过导管插入装置的一个定位管。使用定位导向件，在心房附件中的植入器件的位置可从传送入的位置重调到一个要求的展开位置。
定位导向件可有一个可膨胀的结构。该结构可从紧凑状态膨胀到膨胀状态。定位导向件在其紧凑状态传送到连接心房附件的门口的位置。装置可包括尺寸调节机构，用来原地膨胀定位导向件。定位导向件可通过膨胀而展开以便与接近作为机械支承的口的心房壁的部分接合或接触。因此，展开的导向件固定及稳定导管插入装置的外部分在一个固定位置。连接到穿过导管插入装置的轴的一个插入装置被可逆地定位在心房附件中。可以用例如回声心动描记、X射线或萤光法来监视插入装置的位置。在插入装置已合适地定位和展开，定位导向件可缩回到其紧凑的非膨胀状态和抽出。
在导管插入装置可用于横过中隔的导管插入的一个实施例中，一个固定装置与导管插入装置中的通道套管连接。该通道套管用来刺穿心房隔壁，随后被送进通过刺穿的隔壁以提供一个植入器件可传送到连接的心房的一个套管。固定装置例如包括一个可膨胀的盘，该盘的膨胀直径比刺穿的中隔的开口的尺寸大几倍。可充气的盘可展开以接合刺穿的隔壁。可充气的盘可展开以与刺穿的中隔的远端表面接合，以把通道套管的位置相对隔壁的位置而固定下来。
定位导向件(和固定装置)的其它实施例可有其它种类的可充气膨胀或可膨胀的结构，该结构允许定位装置(和固定装置)有紧凑的尺寸作传送，和可随后就地扩大。
通过下面的详细说明，可明白本发明的其它特征、性能和各种优点。
附图说明
图1是一个心脏的部分横剖面图示出使用横过中隔的处置进入左心房附件的普通导管；
图2a和2b示出按照本发明原理设置的膨胀的定位导向件的金属丝图案或结构的实例；
图2c示意地示出按照本发明原理的充气气球型的定位导向件；
图3示出具有定位导向件的横过中隔的导管插入装置的一部分的示意图，该装置用于在心房附件中可逆的或可调节地放置一个植入器件，还有固定装置用来按照本发明的原理限制横过中隔的通道鞘的运动；
图4是图3的横过中隔的导管插入装置的一部分的示意图，示出按照本发明原理的用来限制横过中隔的通道鞘的运动的固定装置的展开图；
图5是图3的横过中隔的导管插入装置的一部分的示意图，示出按照本发明原理的与接近心房附件的口的心房壁表面接合的定位导向件的展开图。
最佳实施例的说明
用于过滤或修改在心房附件与心房之间的血流的植入器件可连接到导管的轴和随后通过导到心脏的血管经皮地导到该附件。
图1示出例如导管21通过下静脉腔18插入通过一个股静脉(未示出)进入心脏的右前房，随后在进入左前房附件13之前，通过卵圆窝19或中隔29进入左前房。或者导管21可通过主动脉12进入左心室16，和随后通过二尖瓣阀17到达左前房附件13(未示出)。连接到导管21的植入器件(未示出)可用来防止由此产生的血栓30或栓子移动进入心房11。该植入器件可包括有合适的性能(如不透射电性)的材料，使其可用外部成像技术(如X射线照相或荧光镜、回声心动记录或超声法)在导管植入前后监视在体内的装置的位置。
本发明提供一个植入器件，具有定位装置或导向件，可以对一个开始的作为输入的植入器件的位置探测或再调节。在心房附件中的植入器件的位置可以从输入的位置重调节到一个要求的使用位置。植入器件可包括一个或多个的套装的管、丝或轴。定位导向件可连接到通过导管装置的定位管。
定位导向件可有一个可膨胀的或充气的结构，可用来接合(接触)包围着房室口的心房壁部分。该结构设计成可从便于经皮地输入及抽出的压紧状态可逆地膨胀。另外，定位导向件可设计成与周围的心房壁部分接合以提供稳定和可重复的通道，用来把装着装置的轴移入或移出心房附件。
定位材料可由合适的双相容的材料制成，包括金属和聚合物材料，如ePFTE[例如戈特克斯(Gortex)]聚酯聚四氟乙烯(例如特氟隆)，不锈钢和形状记忆合金(例如镍钛诺)纤维或丝。
按照一个实施例，定位导向件可由丝段制成。丝可以由合适的弹性材料制成，如形状记忆合金材料(如镍钛诺)。有一个或多根丝或丝结构，可制成定位导向件。在定位导向件适于经皮的输入的紧凑状态，丝可以位于沿着定位管。例如由形状记忆合金材料制的丝或丝结构可有预成形的形状。在定位导向件的膨胀状态，这些丝可转回到它们的预成形的形状，在该形状下，它们可从定位管延伸出。延伸的丝可有各种合适的形状结构用来与心房的壁部分接合。例如，延伸的丝可有直的辐条形图案或有更复杂的图案，如搭接的弧形图案。图2示出例如在定位导向件500膨胀或使用状态中的丝510的辐条形结构。丝510从定位管520径向延伸出，导向件500设在定位管520上。另外，图2示出例如在定位导向件550的膨胀或使用状态中的丝510的搭接的弧形图案。
导管插入装置可包括合适的尺寸调节机构，允许定位导向件就地可逆地膨胀。例如，该装置可包括可抽出的套管，该套管覆盖及固定住形成定向导向件的弹性或形状记忆合金丝在沿着或接近定位管的紧凑状态。定位装置可通过抽出导向管而使用，以允许丝膨胀或径向向外展开。套管可向前移动以便按要求把定位导向件从膨胀状态返回到紧凑状态。或者，丝可以容放在输送管中，和例如连接到一个滑动推杆，以允许丝可抽出地延伸通过在输送管壁的小直径开口或孔中。
在非膨胀的紧凑状态，定位导向件传送到连接心房附件的口的位置。通过膨胀定位导向件被展开，以与邻近心房口的用于机械支承心房壁的部分接合或接触。最外的接合点可以分开比定位管直径大的距离。优选地，分开的距离比定位管直径大几倍，以得到有利机械稳定性的有较宽几何尺寸的支承结构。或者，定位导向件可适当地往前输送支承在心房壁部分，其中接触压力是适当的以产生对其侧向运动的摩擦阻力。因此，展开的定位导向件可机械夹持定位管，把其稳定在相对心房口的一固定位置。连接到通过定位管的轴上的一个植入器件可随后放置在心房附件中的一个位置。植入器件的位置可监视，例如由电心动记录图、X光照相或荧光成像来监视。在植入装置合适地定位或展开后，定位导向件可收缩及抽出。
定位导向件的其它实施例可以有其它的充气或膨胀结构，使定位导向件可有紧凑的尺寸作传送和随后可就地扩大。例如，按照一个实施例，定位导向件可有充气的气球型结构。气球可由合适的弹性材料制成，例如用尿烷或硅橡胶材料制成。例如图2c示出一个定位导向件570的气球型结构560。
导管插入装置的一个实施例可以用于横过中隔的导管插入。该实施例的装置有一个通道套管，该套管用来作为把装置传送穿过在相连的心房之间的中隔的一个导管或通道。该装置包括一个固定装置，可用来限制与横过中隔的通道套管。该固定装置设在通道导管的前端上或前端附近。
该通道套管可以是导管插入装置最外面的管。已知的导管插入技术可用来把通道套管穿过和横过中隔。例如，一个已知的技术使用一个普通的膨胀器(密塞器)装置，该装置的尖端有覆盖的针。膨胀器预先装在通道导管中使得膨胀器尖端从通道套管的远端延伸出。该预装的通道套管通过人体的脉管系统向前送入一个心房。接着，膨胀器针向前送通过膨胀器尖端以刺穿心房的中隔，接着膨胀器本身向前送使膨胀刺穿的开口。通道套管随后向前送通过膨胀的刺穿开口，穿过中隔进入连接的心房。最后，膨胀器装置从通道套管中抽出。
在本发明的导管插入装置中的固定装置可以展开以限制横过中隔的通道套管的进一步运动。例如，固定装置可以包括充气膨胀盘，其充气膨胀直径比中隔的刺穿开口的尺寸或通道套管的直径大。优选地，充气膨胀直径比通道套管直径大几倍。用于处理成人心脏的导管插入装置中，例如充气膨胀直径可在约5-10mm的范围内。充气膨胀盘可由如硅橡胶、尿烷之类的双相容的材料或其它的双相容的聚合物。
导管插入装置可包括合适的装置用来可逆地充气膨胀固定装置。例如，通道套管可包括与可充气膨胀的盘结构连接的管，通过该管，压力流体可供入以膨胀盘。可充气膨胀的盘可展开以与刺穿的中隔的远端表面接合以固定通道套管相对中隔的位置和限制通道套管的偶然的移动。
固定装置的其它实施例可以有其它的可充气膨胀或可膨胀的结构，该结构允许固定装有紧凑的尺寸作传送和以后可就地扩大。
例如图2示出横过中隔的导管插入装置200，该装置有定位导向件200，用来可逆地把一个插入装置210放入心房附件中，还有固定装置230用来限制横过中隔的通道套管240的偶然的或非控制的运动。
装置200包括同轴地座入的通道套管240，传送管260，定位管270，和装置轴280，所有这些部件连接或穿过处理歧管250。
通道套管240可形成导管插入装置200的外管结构。刚性的双可相容性的管材料(如金属和塑料)可用来制造导管通道240。但是，通道套管240可足够地柔性以便穿过导入心脏的血管。通道套管240的外径可适合于经皮的通过方便接近的血管(例如股静脉)到心脏的通道。
通道套管240的另一端(近端)连接到处理歧管250上。可充气膨胀的固定装置230可设在通道套管200上或设在其中，朝着其远端。固定装置可例如由通过设在歧管230上的充气口254喷入的压力流体而可逆地膨胀。
处理歧管250包括流体密封件252，一个传送管260穿过该结构和可逆地延伸进入通道套管240中。流体密封件252可以是设计用来防止在传送管260抽出或延伸进入通道套管240时防止流体的漏泄。例如，流体密封件252可以是普通的气密密封件。与用于制造通道套管240的类似的刚性的双可相容性的管材料(如金属和塑料)可用来制造传送管260。传送管260可有足够的柔性，在通道套管通过血管导入心脏的展开位置，传送管260可穿过通道套管。传送管的外径尺寸允许其在通道套管240中光滑运动。传送管260的外径比通道套管240的内径足够小以允许压力流体在固定装置230和充气口254之间流过。可以另外是或者，传送管260的外表面可以带槽，以提供压力流体在固定装置230和充气口254之间流过。
传送管260的内径足够大以接受和允许设在定位管270的远端上的定位导向件220通过。与用于制造通道套管240或传送管260类似的刚性的双可相容性的管材料(如金属和塑料)也可用于制造定位管270。定位管270可足够的柔性，在传送管通过通道套管导入心脏的展开位置，定位管270可有传送管260。定位管270可通过设在传送管260近端的密封件256可抽回地延伸进入传送管260。密封件256设计成防流体密封，例如可以是类似流体密封件252的类型。
设在定位管250的远端上的定位导向件220可有一个紧凑状态，导向件220可从紧凑状态可逆地膨胀成膨胀状态。图2示出作为实例的定位导向件220在其膨胀状态。膨胀的定位导向件220的结构有四个延伸的指222以便接合或接触作为机械支承的心房壁以稳定定位管270的位置。图3示出的四个延伸的指的尺寸比传送管260的直径大。但是，可以明白仅仅当传送管在紧凑的缩回状态，定位导向件220可送过传送管260。定位管270可包括绊丝、推杆、可缩回的衬套或其它的合适装置以便可逆地展开定位导向件220。例如定位管270本身可作为推杆，在这种情形下，通过选进或抽回定位管270通过传送管260，定位管220可膨胀或缩回。
定位管270的内径的尺寸足够大以接受连接到装置轴280一端的紧凑的插入装置210及允许其通过。例如，插入装置210可以是例如US专利申请09/426,008号，US专利申请09/614,091号，US专利申请09/642,291号，US专利申请09/697,628号，US专利申请09/932,512号公开的自膨胀或可充气膨胀的过滤装置，这些文件结合作为本申请的参考。例如，装置轴280可有一个由实心金属、金属带、实心聚合物、聚合物的带、或这些材料的组合制成的实心的或管形的结构。轴280可包住对装置展开需要的其它的管或结构。例如装置轴280可包括一些腔用来供应可膨胀一个充气膨胀的气球的流体供入气球充气型装置210。
导管插入装置200(或其它实施例)可控制地和可调整地把插入装置放入在心房附件中的合适的展开位置。定位导向件和/或固定装置230可用于提供一个机械稳定的通道用于传送装置和在装置展开前调节装置在心房附件中的位置。
参照图4，在一个横过中隔的导管插入程序中，固定装置230在其紧凑状态的通道套管240通过人体的脉管导入右心房330。通道套管240通过人体的进展可由回声心动记录、X射线或荧光成像来监视。一个可逆地滑动通过通道套管240的普通的针和扩张组件(未示出)可用来刺破和扩张中隔310。通道套管240向前送进通过中隔310进入左心房320。在设在通道套管240的远端上的固定装置230送进通过中隔310后，通道套管240的向前送进运动可停止。随后固定装置230可由通过充气口254喷入的压力流体展开。采用固定装置230，通道套管240的充气膨胀运动可通过装置230与中隔310的远端壁表面的接合而被限制。该接合可防止通道套管300的偶然发生的反向运动或滑动，例如在送进其它的结构(如紧密配合的传送管260)通过通道套管230的作用时的反作用力会产生上述的运动。图4示出通道套管240，其中突入左心房320的一段套管241被充气膨胀的固定装置230固定对着中隔310，和提供了把传送管260通入左心房320的机械稳定的导管。
包括定位导向件220的插入装置210和其它导管结构可以穿过传送管260进入左心房320。图5示出展开定位导向件220接近左心房附件420的口410接合作为机械支承的心房壁表面430。
在通道套管240被充气膨胀的固定装置230固定对着中隔310后，传送管260导入左心房320，定位管270带有定位导向件220在其紧凑位置，被送进通过传送管260进入左心房320。定位管270足够送入左心房320使得定位导向件220顶对着或很接近房室的口410。随后展开定位导向件220使得它与包着口410的心房壁430的表面部分接合。在图5中，方向A图示出在导向件220运动中指222的运动。在展开指222从沿着定位管270的缩回结构到一个膨胀结构，其中指222径向向外张开。膨胀结构的指222与作为机械支承的心房壁430接合。通过接合或接触心房壁430，定位导向件220使管260和270相对心房附件420的位置机械稳定。连接到轴280的插入装置210可传送到心房附件420内的位置，同时传送定位导向件220到贴对着或很接近房室的口的位置。或者，可以在定位导向件220已展开以接合作为机械支承的心房壁430后传送植入装置210。通过定位管270，被展开的定位导向件220固定在比较固定的位置，装置210的位置可由使轴280滑动通过由展开的定位导向件220固定在较固定位置的定位管270提供的稳定的通道来调节。
可以明白上面只示出本发明的原理，在不背离本发明精神范围的情况下，本专业技术人员可以作出很多改型。可以明白此处使用的“近端”或“远端”及其它方向的术语只是为说明方便，不是打算用这些术语说明固定的或绝对的方向。

Claims (38)

1.一种导管插入装置，用于横过中隔地传送一个器件，所述的导管插入装置包括：
一个套管，用于横过中隔和建立一个横过中隔的管道，用于把所述的器件传送通过所述的中隔；
固定装置，设在所述的套管上，用于限制所述的套管相对被横过的中隔的运动；和
一根轴，用于传送所述的装置通过所述的套管穿过所述的中隔。
2.按照权利要求1所述的装置，其特征在于所述的套管包括一个固定的管。
3.按照权利要求1所述的装置，其特征在于所述的固定装置包括一个可逆地膨胀的结构。
4.按照权利要求3所述的装置，其特征在于在膨胀时，所述的可逆地膨胀的结构与所述的被横过的中隔的表面部分接合。
5.按照权利要求3所述的装置，其特征在于所述的膨胀结构包括一个可充气膨胀的结构。
6.按照权利要求5的装置，其特征在于所述的套管还包括腔，用来把加压流体供入以膨胀所述的充气膨胀的结构。
7.按照权利要求5的装置，其特征在于所述的可充气膨胀的结构由弹性膜片制成。
8.按照权利要求5的装置，其特征在于所述的可充气膨胀的结构的充气膨胀直径比所述的套管的直径大几倍。
9.一种在导管插入过程中设置用于传送器件的横过中隔的管道的方法，包括：
提供一个导管插入装置，包括：
一个套管，用于横过一个中隔，其中所述的套管包括腔，用于器件在其中运动，和
固定装置，设置在所述的套管上用来限制所述的套管相对所述的被横过的中隔的运动，
刺穿所述的中隔和扩张所述的中隔，
送进所述的套管穿过所述的被横过的中隔，使所述的固定装置穿过所述的中隔；和
展开所述的固定装置以接合所述的中隔的表面部分和限制所述的套管的进一步运动。
10.按照权利要求9的方法，其特征在于所述的提供一个导管插入装置还包括提供所述的套管成一个柔性管的形式。
11.按照权利要求9的方法，其特征在于所述的提供一个导管插入装置还包括提供所述的固定装置有一个可逆的膨胀结构。
12.按照权利要求11的方法，其特征在于所述的提供所述的固定装置有一个可逆的膨胀结构还包括提供一个结构，当膨胀时该结构与所述的被横过的中隔的表面部分接合。
13.按照权利要求11的方法，其特征在于所述的提供所述的固定装置有一个可逆转的膨胀结构还包括提供一个可充气膨胀的结构。
14.按照权利要求13的方法，其特征在于所述的提供所述的套管还包括提供一个套管，有腔，用以供应加压流体以充气膨胀所述的可充气膨胀的结构。
15.按照权利要求13的方法，其特征在于提供所述的可充气膨胀的结构还包括提供由弹性膜片制造的可充气膨胀的结构。
16.按照权利要求13的方法，其特征在于所述的可充气膨胀的结构还包括提供一个可充气膨胀的结构，其可充气膨胀的直径是所述的套管的直径的几倍大。
17.一种把一个器件插入心房附件中的导管插入装置，包括：
一个管组件，用来提供一个所述的器件通过人体的脉管和所述的心房到所述的附件的运动通道，所述的组件包括至少一个外管。
一个轴，用于传送所述的器件通过所述的组件；和
一个定位导向件，用于接合所述心房壁部分，该部分作为在所述的心房中对所述的管组件部分的机械支承。
18.按照权利要求17的装置，其特征在于所述的定位导向件设在可缩回地延伸通过所述的外管的定位管上。
19.按照权利要求17的装置，其特征在于所述的定位导向件包括一个可缩回地膨胀的结构。
20.按照权利要求19的装置，其特征在于所述的可逆地膨胀的结构包括至少一个预成形的丝结构。
21.按照权利要求19的装置，其特征在于所述的可逆地膨胀的结构包括一个可膨胀的气球。
22.按照权利要求21的装置，其特征在于所述的组件还包括腔，用于供送加压流体以膨胀所述的可膨胀的结构。
23.按照权利要求17的装置，其特征在于所述的管组件还包括一个传送管，用来把所述的定位导向件传过所述的管组件到接近所述的附件的一个位置，所述的传送管可缩回地延伸通过所述的外管。
24.按照权利要求23的装置，其特征在于所述的管组件还包括一个定位管，所述的定位管可缩回地延伸通过所述的传送管，其中所述的定位导向件设在所述的定位管的一端部。
25.按照权利要求17的装置，其特征在于还包括一个固定装置，设在所述的外管的一端，其中所述的固定部分与被所述的外管横过的中隔的表面部分接合，以限制所述的外管的进一步运动。
26.按照权利要求15的装置，其特征在于所述的固定装置包括可逆转膨胀的结构。
27.按照权利要求26的装置，其特征在于所述的可膨胀的结构是一个可逆地膨胀的结构。
28.一种把一个器件插入在一个心房附件中的方法，包括：
提供一个导管插入装置，
一个管组件，用来提供使所述的器件通过人体的脉管和通过所述的心房到所述的附件的运动的通道，所述的管组件包括至少一个外管；
一个轴，用来传送所述的装置通过所述的组件；和
一个定位导向件，用于接合所述的心房壁部分，该部分作为在所述的心房中对所述的管组件部分的机械支承；
送进所述的管组件通过一个血管以建立到所述的心房的通道，
把所述的定位导向件导到在所述的附件的口的附近的一个位置；
展开所述的定位导向件以接合作为机械支承的心房壁部分；和
使用所述的轴传送所述的器件通过所述的通道到在所述的附件中的一个位置。
29.按照权利要求28的方法，其特征在于提供所述的导管插入装置的步骤还包括提供一个定位导向件，设在可逆地膨胀通过所述的外管的所述的导向管上。
30.按照权利要求28的方法，其特征在于提供所述的定位导向件的步骤还包括提供一个具有可逆地膨胀的结构的定位导向件。
31.按照权利要求30的方法，其特征在于提供所述的可逆地膨胀的结构包括至少一个预成形的丝结构。
32.按照权利要求30的方法，其特征在于所述的可逆地膨胀的结构包括提供一个可充气膨胀的气球。
33.按照权利要求32的方法，其特征在于提供所述的管组件的步骤还包括提供腔，用来供送加压流体以充气膨胀所述的可充气膨胀的气球。
34.按照权利要求28的方法，其特征在于提供所述的管组件的步骤还包括提供一个传送管，用来传送所述的定位导向件通过所述的管组件到接近于所述的附件的一个位置，和所述的传送管可缩回地延伸通过所述的外管。
35.按照权利要求34的方法，其特征在于提供所述的管组件的步骤还包括提供一个定位管，可缩回地延伸通过所述的传送管，和所述的定位导向件设在所述的定位管的一端。
36.按照权利要求28的方法，其特征在于提供所述的管组件的步骤包括提供一个固定装置，设在所述的外管的一端，和所述的固定装置接合被所述外管横过的一个中隔的表面部分以限制所述的外管的进一步的运动。
37.按照权利要求36的方法，其特征在于提供所述的固定装置的步骤还包括提供一个具有可逆地膨胀的结构的固定装置。
38.按照权利要求37的方法，其特征在于提供所述的固定装置具有一个可逆地膨胀的结构包括提供一个由弹性膜片制的可充气膨胀的结构。
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