CN1216930A - 间质经血管介入的装置,系统和方法 - Google Patents
间质经血管介入的装置,系统和方法 Download PDFInfo
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- CN1216930A CN1216930A CN97193556A CN97193556A CN1216930A CN 1216930 A CN1216930 A CN 1216930A CN 97193556 A CN97193556 A CN 97193556A CN 97193556 A CN97193556 A CN 97193556A CN 1216930 A CN1216930 A CN 1216930A
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- graft
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Abstract
本发明为用于经血管的间质介入术的装置,系统和方法,其中包括经血管的,基于导管的血管分流术,经心肌的血管重建术,血管的分流移植,和间质的外科/介入操作,其中导管经腔地通过血管系统(2)前进到所要求的部位(OB),同时一个手术器具(5)通过血管(2)的壁(2)到达目标部位(3)(例如,另一个血管,一个器官,一个肿瘤,另一个解剖学结构),从而使一个或多个手术装置进入目标部位以实施所要求的手术或介入操作。
Description
相关申请
本专利中请要求对1996年2月2日提出的美国临时专利申请系列No.60/010,614的优先权,其全部公开的内容在这里都清楚地被引入参考文献。
另外,与其一道同时提出的为三个单独的申请,题为:用于阻塞通过血管的流动的方法与装置,用于解剖学通道吻合术的方法与装置,和用于在血管和其它解剖学结构之间形成通道的导管和相应的装置,其中的每一个都包括了最初包含在美国临时专利申请系列No.60/010,614中的主题并且都要求对该临时申请的优先权。
发明背景
ⅰ.经皮经血管的动脉分流术
动脉粥样硬化是一种进行性的疾病过程,其中动脉腔内的血流因通常被称为动脉粥样硬化斑块的阻塞而受到限制。在心脏中,以及在其周边,动脉的阻塞可以导致疼痛,功能丧失和甚至死亡。多年来曾使用了大量的方法在动脉阻塞的下游组织中进行血管重建。这些方法包括利用人工方法对原地静脉或移植的静脉移植物进行分流移植术,以及血管成形术,粥样硬化斑切除术和最近的经心肌的激光血管重建术。分流移植术曾是极其成功的,但是,该项操作需要大的外科手术。最近,由厂家Heartport,Inc.和Cardiothoracic Systems Inc.所从事的诸如经胸腔的内窥操作的较新颖的技术表明了不需要过多侵入的分流冠状血管的方法。这些操作是很难实施的而难于广泛应用。而经心肌的激光血管重建术,即一种在心脏的壁上钻出一个小孔的技术,看来是有前途的,但操作的方法还未能很好地被了解,问题在于形成通道的激光能量的应用。然而,临床医生对该项技术仍然很感兴趣,因为其具有最少侵入的可能且不需要将患者置于体外循环之中。
在70年代一些心血管外科医生试验利用心静脉进行血管重建术。此项操作被用于具有多个狭窄的冠状血管的患者。该项技术包括使用取自体内的乳房动脉或主动脉到隐静脉的附着体的介入移植物。移植物不是缝合在远端的冠状动脉而是在相同的位置连接在冠状静脉或心静脉上。随后静脉的近端部分被缝合以防止分流,然后除去患者的体外循环,胸膛被关闭。在这一模式中,静脉被“动脉化”,允许血液以逆向的形式流动并能够将充氧的血液送到心脏的小静脉和毛细血管。此项技术的成功之处已发生极大的改变,其大部分已被抛弃。问题在于吻合处的狭窄,心脏内破裂的小静脉出血,和移植物中血栓的形成。
这里所公开的装置,系统和方法提出一种经皮的血管重建术。在这里,心脏的静脉或者被动脉化,或者简单地用作分流的移植物。未见有提出此种意向的文献。虽然在周围原位形成分流移植物,仍需做一切口以连接和结扎静脉的端部。另一种与此项技术有某些相似之处的操作被称为TIPS(经颈静脉肝内门体循环分流)方法。在该方法中,将一个斯滕特固定模送入肝组织中以连接门静脉和下方的静脉腔。尽管该方法可以经皮完成,但其目的并不是为了一个器官的血管重建或是绕过血管内的阻塞物,不允许两个血管中的任何一个逆行,没有伴随的血栓形成,和需要使用一个斯滕特固定模。另外,其装置和方法显得过大且不具备进入例如在心脏中存在的较小血管所必须的定向的能力。
ⅱ.经血管血管间间质术
开放式外科手术是多年来得以进入组织实施外科操作的唯一途径。随着光学器件的出现,各种内窥操作得以发展。开始,这些操作利用例如尿道,口腔,鼻泪管和肛门等天然开口。最近,使用经腹壁和经胸腔部分的新技术得到了发展。这些胸腔镜的或腹腔镜的操作所采用的都是与开放式外科手术器具相应的带有长柄的器具。通常需要全麻,仍有一些较小的需要愈合的伤口。
这一方法存在的另一问题是解剖一致性参照点的识别。对于精密的外科手术,例如在脑部,通常需要在患者的头部附加一个支架以提供这一参照。最近,开发出一种“小支架”系统,该系统使用非常小的上面带有一些发光二极管(LEDs)的支架。利用连接在顶部的三个摄像机使这些发光二极管与器具本身上的发光二极管发生连系。这将有助于建立支架与界标之间的关联,同时保证了器具的正确的定位。虽然这看似一种极大的努力,但它说明了能够进入所要求的准确位置的重要性。
在传统上,进入血管系统的唯一目的是寻找血管的问题。现在血管成形术,粥样硬化斑切除术,斯滕特固定模,激光血管成形术,血栓溶解和甚至心内活检装置都被认定为进入血管的用途。
ⅲ.腔内封闭
如今,有一些可用于封闭人体中的开口,血管或管状结构,包括例如血管重建的方法。一种方法是使用适于外部使用的装置,诸如卡钉,夹子,缝合线或由外部对开口施压的装置以及使用能量将其焊接例如Keppinger Forceps。尽管这些方法是很成功的,它们都需要由外部进入结构。然而,在基于导管的某些发明的情况下,这并不总是可能的。
另一种方法,可与导管方法相容,包括使用腔内装置诸如可分离的线圈,气囊,可注入的粘结剂或栓塞物。这些解决办法都受限于需要使用一个外部的物体以形成一个阻塞物。再有,外部物体的存在可能在以后造成其它问题。例如,这些装置可能移动,或导致很关紧要的严重组织的反应。
发明概述
本发明提供了以血管系统作为通道并用以在血管内外进行介入术的装置,系统,和方法。根据一个实施方案,在一个适合的入口处将一个装置送入血管系统,并前进到一个特定的目标部位,在该入口处形成一个开口,以使该装置或另一装置或一些装置通过或围绕该入口进入血管内部以外的部位。在一个实施方案中,一个系统被用作一种出入可实施一项操作的部位的通道,这种操作可以很好地用于冷却或烧蚀一定体积的组织,注射或注入药物,物体或材料,切割,处理或取回组织,为内窥检查或治疗提供出入口,放置一种可置入的或暂时的装置,或形成另一个通道,并经该通道可实施血管重建使血液得以流通或实施其它外科手术。在另一实施方案中,该系统用以经皮由外部进入的分流术。特别是使用该系统同时在靠近第一开口的地方在相邻血管上形成第二开口,从而在两个血管或通道之间形成一个吻合通道,以使血流从中通过。这种操作可用以形成另一个血管通道以提供另一个血管重建的路径,例如在心脏中的冠状动脉和心静脉之间,或在心脏周边相邻的静脉,通道和/或动脉之间形成通道。在本发明的一个实施方案中,具有第二开口的血管可以是一个原地的血管,一个天然的或人工的移植物区段,或是一个移植的血管,所有这些都以左右相邻的形式连接在具有第一开口的血管上。换句话说,每个上面都具有由该系统形成的基本上大小相同的开口的两个相邻的血管可以保持为相对平行地靠近的形式而不是传统的端部-对-侧边的形式。另一个特殊性在于该系统可用以分流冠状动脉,并提供心静脉动脉化或区段的移植。另外,适应解剖学标志的血管供应的稳定性提供了在成象或其它引导装置下重复进入血管周边结构的一种简单的方法。这可能对进入脑,肾,肺,肝,脾以及其它组织内部区域是特别有用的,并显示出优于在组织上标记定位、外部构架或所谓的“小构架”外部器具定位系统的明显的优点。在另一个实施方案中,使用该系统在血管近端形成一个开口,在血管附近的组织中钻孔,并在远端处再回到该血管中。这可能对绕过血管的病变处为血流提供另一通道是有用的。本发明的最后一个实施方案包括一种用以封闭一个开口例如一个血管的腔的系统,它在形成一个血管重建路径,使血液经其绕过病变部位后封闭该开口。该系统可使用一个抽吸机构以首先吸拉血管壁使其腔暂时地被封闭。然后该系统提供将血管壁彼此牢固地固定的装置以将腔封闭。
根据本发明的一个特定的实施方案,提供了用于经心肌的血管重建术的方法与装置,以在一个或多个冠状血管和心脏的一个或多个腔室之间形成经心肌的通道或孔道,以使血液从心脏的腔流过经心肌的通道从而增强心肌区域的灌注。在某些情况下,这可以使本发明的形成-通道的导管穿过冠状窦并进入冠状静脉来完成。随后,利用形成-通道的导管形成许多由心静脉进入左心的腔,优选地为左心室的经心肌的通道或孔道。然后,移走形成-通道的导管而冠状静脉保持为无阻塞,无血栓形成或无结扎形成,从而使充氧的血液由左心室自由地流过经心肌的通道,通过冠状静脉回到冠状窦。这时,一种连续的无阻塞的动脉血流将由左心室流入经心肌的通道,从而提供对该区域心肌的增强的供氧和灌注。
附图简述
图1为人的心脏前面的透视图,其中导管已被插入以施行经腔的冠状血管重建操作,其中一段冠状静脉被用作分流通道以绕过冠状动脉中的梗塞。
图1a为图1中区间1a内相邻的冠状动脉和冠状静脉的放大的剖面图。
图2为通过图1所示的心脏的一部分的放大的部分剖面图。
图3a为本发明的具有在其上形成的定向标识系统的第一个实施方案的形成-通道的导管装置的透视图。
图3b为图3a中所示导管的透视图,其中导管相对于图3a所示的转动了90度。
图3c为本发明的具有在其上形成的定向标识配置的第二个实施方案的另一个形成-通道的导管的透视图。
图3d为图3c中所示导管的透视图,其中导管相对于图3c所示的转动了90度。
图3e为通过本发明的具有在其上形成定向标识系统的第三个实施方案的另一个导管的横剖面图。
图3f为图3e中所示导管的部分透视图,其中导管相对于图3e所示的转动了约45度。
图4为根据本发明将一个分流移植物连接到冠状动脉的操作的透视图。
图5为用于在图4中所示的操作中在移植物和冠状动脉之间形成通道和连接的形成-通道的探头装置远端部分的放大的视图。
图6为图4中区间6的放大的剖面透视图。
图6a为在图4的操作中在移植物和冠状动脉之间形成的通道和连接的放大的视图。
图7为人的胸部的一部分的透视图,表示一种最小侵入的原位分流的操作以绕过冠状血管或周边血管中的阻塞物的方法。
图8为相邻的动脉和静脉的透视剖面图,其中具有一个导引器和已插入其中的本发明的介入导管,用以进行原位分流操作,以使血液由血管中的一个流入另一血管的腔内。
图9为一个剖面透视图,表示根据本发明的原位分流或分流移植术操作的最后结果。
图10为两个相邻血管的纵剖面图,其中具有根据本发明的在其间形成的血流通道,和一个放置在分流血管腔内的腔阻塞装置,以便于分流的血液沿所要求的方向流入分流血管。
图11a为一个带有自膨胀栓塞装置的投送导管的纵剖面图,其中栓塞装置为一种凝胶泡沫海绵体,放置在导管腔内并沿预先置入的导线前进。
图11b表示图11a中的导管,其中自膨胀栓塞装置为凝胶泡沫海绵体,已前进到导管远端之外并越过导线。
图12a为一个单向阀斯滕特固定模装置的透视图,该装置用于促进根据本发明的方法在血管间或其它解剖学结构之间形成的通道内的单向的流动。
图12b为图12a所示装置的侧视图。
图13为相邻血管的纵剖面图,在其间具有根据本发明所形成的血流通道或吻合管道,并具有放置在通道或管道内同时伸进血管腔内的凸出的斯滕特固定模,此凸出的斯滕特固定模可以整个地或部分地由相对致密的材料制成,以阻塞通过至少一个血管腔中血液的自然流动。
图14为相邻血管的纵剖面图,相邻的血管具有在其间形成的血流通道(即,一个吻合管道),并具有一个安放在血管通道(即,一个吻合管道)内的非-凸出的斯滕特固定模,以保持血流通道(即,一个吻合管道)的尺寸。
图15为相邻血管的纵剖面图,其上具有根据本发明在其间形成的血流通道或吻合管道,该血流通道或吻合管道被以扩张通道或吻合管道为目的经由导线导入的气囊所扩张。
图16为两个相邻血管的纵剖面图,其上具有根据本发明在其间形成的在开始时刺穿的通道或管道,同时还示出一个能量发射气化导管,导管经由一个导线前进,该导线已经穿过了在开始时形成的刺穿的通道或管道,所说的气化导管可进行运作以形成具有所需尺寸的最后的通道或管道。
图17为相邻血管的纵剖面图,其上具有根据本发明在其间形成的血流通道或吻合管道,且其中使用了本发明的一个焊接导管系统用以焊接或熔合血流通道或吻合管道周围的组织,从而在位于相邻处的血管上形成的开口之间确立牢固的连接。
图18为相邻血管的纵剖面图,其上具有根据本发明在其间形成的血流通道或吻合管道,同时具有一个覆盖通道或吻合管道壁的聚合物斯滕特固定模。
图19为相邻血管的纵剖面图,其上具有在其间形成的血流通道或吻合管道,并具有一个位于所说的通道或管道内根据本发明的卡钉导管,用以插入卡钉将血管连接在一起并保持通道或管道按照需要对准。
图19a-19c按步骤地表示图19所示的卡钉导管被用来在血流通道或吻合管道内插入卡钉的方式。
图20为相邻血管的纵剖面图,其上具有在其间形成的血流通道或吻合管道,并具有根据本发明的设置-夹子的导管装置,装置穿过通道或管道以在其中设置夹子。
图20a为图20中所示血管的纵剖面图,其中具有根据本发明设置在形成于血管之间的通道或吻合管道内的夹子。
图21为相邻血管的纵剖面图,其上具有根据本发明在其间形成的血流通道或吻合管道,同时焊接导管装置的另一个实施方案穿过该通道或管道以熔合或焊接管道周围的组织。
图22为相邻的冠状动脉和冠状静脉的纵剖面图,其中根据本发明在原地的冠状分流操作已经完成。
图23a为一血管的纵剖面图,其中经皮插入了一个根据本发明的TVIS的插入部分。
图23b为一血管的纵剖面图,其中具有根据本发明的TVIS的插入部分的另一个实施方案,可包括一个由其中插入的气囊。
图24为一血管的纵剖面图,其中具有置于其中的根据本发明的TVIS导引导管,和一个TVIS装置(即,形成通道的导管)穿过该导引导管向前行进。
图25为根据本发明的一个TVIS导管的另一个实施方案的透视图,其中具有一个在其上形成或连接在其上的活动的成象部件。
图26为相邻血管的纵剖面图,具有一个开始在其间形成的刺穿的通道和放置在其中的根据本发明装在导管上的后退的组织切割组件,以将开始时刺穿的通道扩大成为所需要的吻合管道或血流通道。
图27为一血管的纵剖面图,其中具有一个装有近端和远端隔离气囊的TVIS导引导管的另一个实施方案。
图28a为一受阻的动脉及其相邻区域内的组织的纵剖面图,其中带有根据本发明的一个TVIS导引导管和TVIS装置,导管和装置已进入相邻的组织以形成绕过受阻部分的间质通道或血流通道。
图28b为图28a所示血管在形成绕过受阻部分的间质通道以后的纵剖面图。
图29a为冠状血管和相邻的心肌部分的剖面图,其中根据本发明的一个TVIS导管或探头已进入冠状血管并用以在心肌中形成间质通道,以增强心肌在该部分的灌注。
图29b为冠状血管和相邻的心肌部分的剖面图,其中根据本发明的另一个TVIS导管或探头已进入冠状血管并用以在心肌中形成间质通道,以增强心肌在该部分的灌注。
图29c为一个分叉的冠状血管的剖面图,其中本发明的一个TVIS导管已经就位,该导管被用来形成一系列的间质通道以增强该区域心肌的灌注。
图29d为一剖面图,示出一冠状静脉和附近的构成左心室侧壁的心肌部分,以及根据本发明在冠状静脉和左心室之间形成的一系列的经心肌的血流通道,冠状静脉保持不阻塞不结扎,从而使充氧的血液可以由左心室穿过经心肌的管道,由冠状静脉流入冠状窦,为该区域的心肌提供连续的增强的灌注。
图29d′为通过图29d所示冠状静脉的纵剖面图。
图30为一血管的纵剖面图,其中具有放置在其中的根据本发明的TVIS导管及其辅助装置。
图31a为根据本发明的TVIS导管的一部分的纵剖面图,其中有一个锁定导线通过。
图31b为图31a中所示的锁定导线装置的透视图。
图32a为根据本发明的一个TVIS导管一部分的透视图,其中包括一个可弯折的或可弯曲的远端部分。
图32b为图32a中所示TVIS导管在不弯曲的直线形状时的平面图。
图33a为相邻血管的纵向透视图,其中本发明的另一个TVIS导管装置正用以在血管之间利用发射气化能量束形成一个通道或吻合管道。
图33b为相邻血管的纵向透视图,其中具有在其间形成的开始时刺穿的管道或通道,和本发明的一个装置从中穿过以拓宽或加大开始时刺穿的通道或管道。
图34a为本发明的一个TVIS导管装置的远端端部的纵剖面图,该装置具有一个缩回的由形状记忆材料制成的刺穿-组织的探头。
图34b为相邻血管的纵剖面图,图34a中所示的TVIS导管已进入其中,图中还示出了形状记忆刺穿-组织的探头已前进到导管的远端之外并在血管之间形成一个初始的刺穿管道或通道。
优选实施方案详述
在这里本发明利用血管系统作为通向人体任何部位的完整的通道。这里所描述的装置,系统,和方法提供了一种为了外科目的可进入间质空间的新方法。在这里描述的本发明提供了可以经皮通过血管系统进入人体任何部位的一个系统,并提供了用以实现某些外科和内科目的的一套基本的器具。
本发明提供了一种经皮的装置用以对由病变的血管供血的器官施行血管重建。根据本发明的另一个实施方案,可以进行全部的冠状动脉多路分流而不需要开胸,全麻或体外循环。
为提供对本发明的全面的理解,本发明的方法将参照装置在经皮地分流心脏冠状动脉病变部位方面的应用进行讨论。然而,如熟悉此项技术的人所了解的,在这里所描述的一般的方法,系统和装置同样可用于对任何血管周围的结构的外科处理。本发明表明了一种最小侵入的外科手术的新概念,即,血管系统单纯地被用作进入所需要的外科目标的通道。在适当的引导下,在该外科的目标,血管周围的部位可以用一种装置刺穿从而可以插入各种器具以达到外科的效果。这些操作的某些例子并非限制地可以包括:经血管进入颅内并随后对各种血管周围的肿瘤,出血,中风影响的范围和病变的区域进行治疗或诊断介入;经血管由脑,心脏,肾脏,肝脏,肺或骨进行组织活检;经血管置入药物,材料或装置,诸如传感器,放射性籽源,铁磁颗粒,气囊,细胞或遗传材料;和经血管分流。
参照图1,示出了一个典型的冠状窦导引导管4,导管已前进到腔静脉7并进入心脏1。尽管没有示出,导引导管4已进入心脏1的右心房内的冠状窦。该导引导管4为通常在此项技术中所熟知的类型,包括一个具有足够柔性和大小的顶端以保证创伤性地插入冠状窦,在其远端具有一个气囊允许反向地注入对比物以允许心脏的静脉系统的成象。经血管的间质(TVIS)导引导管5通过导引导管4插入并沿一个导线28经过一个心静脉3进入靠近冠状动脉2的所需要的部位。图中表示一个TVIS探头27已通过TVIS导引导管5经心静脉3上的开口进入冠状动脉2中所需的部位。
图2更为详细地表示在TVIS导引导管5上可能具有的各种功能和部件。在这里TVIS导引导管5在心静脉3内沿导线28前进。在TVIS导引导管5上提供了一个气囊21,其目的在于阻塞血流,使导管在腔内保持稳定,或使通道扩张。TVIS导引导管5还装备有主动方向探测装置23和被动探测装置22中的一个或者两个。被动探测装置22可由一组已知材料中的任何一种制成,该材料将允许用X射线照相,荧光镜,磁,超声或电磁探测体内TVIS导引导管5远端部分的位置和方向。这些材料并非限定地包括任何射线透不过的材料,诸如钡或钢,任何铁磁材料例如带有铁的材料,或任何对声波构成足够干扰的诸如夹有气泡的材料或合成材料,刻槽的金属或一些层压材料。主动定向探测装置23能够在血管腔内,在目前的情况下为心静脉3,对TVIS导引导管5上的远端部分准确地进行360度的定向。该主动定向探测装置23可以并非限制地使用以下技术方案中的任何一种:主动定向探测装置23可以是一个简单的压电的线或基于硅的极板,能够发送和接收信号以检测一个相邻血管内血流的存在及其速度;该装置可以是一个与一个发射器相关的接收器阵列以便提供周围组织的图像;该装置也可以是一个简单的能够发送信号到此例中位于冠状动脉2内的导线202的发射器,其中导线202还可进一步改进为具有一个小的接收器/发射器203和线束204,能够在检测主动定向探测装置23发出的信号时反馈给操作人员一个信号;返回系统也可使小的接收器/发射器203发送一个信号给主动定向探测装置23;关于定向探测装置23,该装置也可以发射或接收任何已知的信号发生器系列的信号,包括声,电磁,光或放射信号。在目前的情况下还可为TVIS导引导管5提供一个附加的开口以便可选择地向血管,在目前的情况下为心静脉3,中注入对比物或液体。一旦TVIS导引导管5的定向得到保证,TVIS探头27和TVIS外套26即可前进穿过心静脉3的壁进入间质空间29并进入冠状动脉2。TVIS探头27和TVIS外套26不需要同时前进并可有以下的格局:TVIS外套26可以具有一个锐利的尖端或是半刚性的套管,能够单独地插入组织内;TVIS探头27可以是相对刚性的线,天线,光制导或能量制导,能够在TVIS外套26的支持下单独地插入组织内;或者,进一步地,TVIS探头27和TVIS外套26可操作地相连接使二者一起进入组织。TVIS探头27和/或TVIS外套26为心静脉3和冠状动脉2两个血管之间提供初始的连接。在本发明的一个实施方案中,TVIS外套26可以由不锈钢,镍钛诺或聚合物材料制成。在TVIS外套26就位以后,一个较软的导线可以通过外套放入,以便于在需进入其它腔时辅助器具的进入。另外,如果进入间质空间实施不同类型的操作则不再需要导线。这一操作可用于由冠状动脉2绕过冠状狭窄处201形成一个分流路径进入心静脉3,在某些情况下可回到冠状动脉2。为进一步保证跨越两个相邻血管的分流路径的精确地形成,例如由一个冠状动脉到一个心静脉,可以在已经插入两个血管中的一个的导管上配置一些如图2所示的被动定向探测装置以正确地确定TVIS探头的方向。作为例子,每个被动定向探测装置4200和4201可放置在导管4202的对侧,如图3a所示。在一个优选实施方案中,探测装置4200和4201是沿着穿过导管4202的直径配置的。在这种情况下,当导管4202绕Z轴旋转时,被动定向探测装置4200和4201随之相应地彼此对准,如图3b所示,使TVIS探头4203可以在一个血管内(未示出)正确地定向,以便随后跨越相邻血管形成分流路径。再有,被动定向探测装置4200和4201在导管4202上可以这样布置,如在图3b的透视图所看到的(即,在被动定向探测装置在相应的彼此对准的情况时),装置与TVIS探头4203的远端部分4204沿Z轴成一直线。
在另一个实施方案中,被动定向探测装置可以设计成如图3c和3d所示的形式。如所示,被动定向探测装置可以包括跨越导管4202直径布置的一个基本上成圆形的部分4205和另一个部分4206。换句话说,4206部分和圆形部分4205的圆心处于沿着穿过导管4202的一个直径上。为在血管内正确地将TVIS探头4203及其远端部分4204对准以跨越一个相邻血管形成分流路径,导管4202绕Z轴转动直到4206部分和圆形部分4205同心地对准,如在图3d的透视图所看到的。
在另一个实施方案中,被动定向探测装置可以配置成如图3e和3f所示的包括许多区段,例如,区段4206和4207。当从导管4202的一端看去,如图3e所示,区段4206和4207沿导管4202的一个直径基本上是平行的。然而,当从一个侧视图看导管4202时,如图3f所示,区段4206和4207并不象图3a和3b所示的那样沿直径对准。相反,这些区段是彼此错位的,从而当导管4202绕Z轴转动使在血管内的TVIS探头(未示出)准确定向时,区段4206和4207与TVIS探头的远端部分4204基本上对准成串。
虽然仅示出了关于被动定向探测装置的三个不同的实施方案,应该了解,例如,在显影显示特殊的几何形状时可以在导管上配置其它几何设计,以便能够做到TVIS探头的正确定向。也可以提供非-几何的实施方案,只要该实施方案能够使TVIS探头正确定向以形成由一个血管内到相邻血管的分流路径。
根据本发明的另一个实施方案,如图4所示,一个分流血管可以左右的形式连接在一个带有狭窄的冠状血管上,以提供一个由外部进入绕过冠状狭窄处的经皮的分流路径。为了理解该特殊的方法,将参照通常用以施行由外部进入经皮进行冠状血管或动脉血管分流的装置加以说明,分流是在其周边利用一个移植物区段,一个原地的血管或一个移植的血管进行的。
图4表示一个利用人工的或生物学的移植物区段在一个冠状血管或一个动脉血管周边进行分流的操作。一个人工的或生物学的移植物区段3101可以朝着体内的一个血管3106放置,在该例子的情况下血管在心脏3107内。移植物区段3101可以由人工的材料制成,诸如PTFE或涤纶,或由生物学材料制成,诸如乳房动脉,隐静脉或其它适合的管形导管。如图4所示,探头3102可以通过移植物区段3101上的进入端3105插入。另外,探头3102可以通过移植物区段3101的一个端部插入其中,或通过一个侧分枝沿着侧移植物区段3101插入。缩拢的结扎缝线3104放置在进入端3105附近以便在完成操作时迅速封闭由进入端3105造成的孔。探头3102放在进入端3105附近以便在完成操作时迅速封闭由进入端3105造成的孔。探头3102通过入口3109放入体壁3108内,探头还具有手柄3110以便控制和调整端部3103。手柄3110可以连接在一定范围的外部设备3111上,例如液体冲洗/抽吸,射频(RF)能量,超声成象硬件,多普勒硬件,内窥成象装置,其它能源,例如微波或激光,和机械的启动装置。探头3102的用途在于提供机械的支持和,如果需要,为欲放置的移植物探测准确的位置。图4中还示出了一个抓紧器3112,用以辅助移植物区段3101的放置和保持稳定。在准确地放置以后,固定缝合或使用一种连接介质3113诸如外科粘结剂以保持移植物在以后的操作中在血管3106上就位。虽然讨论的是与心脏相关的操作,应该了解该操作同样可用于其周边的动脉血管。
图5详细地说明了图4所示探头3102的端部。图中示出一个探头把手,它终止于探头端部3201。在本发明的一个实施方案中,端部3201相对于把手3207放置的角度3208是可变的。另外,端部3201和把手3207之间的角度可以是固定的。在端部3201上,探测装置3202可放置在或靠近于(如图示)进入装置3205上。探测装置3202提供关于进入装置3205正确定位的信息,并可以是一个多普勒成象仪或探测仪,超声成象仪或探测仪,或其它能够检测所需的脉管结构,例如一个血管,的存在的探测装置。在血管可以清晰地看到的情况下,这种探测形式可以不需要。然而,进入装置3205可以造成多种形状。图5所示的形状能够用于经由进入装置送入一个柔性的外套3204,和由其中经皮地送入一个导线3206。另外,一个锐利的线可以在包以柔性外套的情况下用以进入血管,以便在随后将锐利的线更换为一个创伤性的导线。图5还梗概地示出了移植物3203环绕着一个探头把手3207和端部3201。如前所述,移植物3203可以是人工的或生物学的移植物区段(或是由附近区域移植的血管)。在移植物3203中的探头正确地定位于带有狭窄部分的血管附近以后,进入装置3205被用来同时穿过移植物3203和相邻血管的壁形成相同大小的开口以便在其间造成一个通道。这样一个吻合通道的出现是优选的,因为它允许在移植物和血管之间引入一个导线,从而使随后的通道尺寸的确定和移植物与血管的连接通过通道来完成。应该了解,任何人工的或生物学的移植物区段(或是由附近区域移植的血管)可以放置在这些结构上或沿其侧边放置,例如股或腘动脉或静脉,冠状动脉或静脉,主动脉,颈动脉或髂动脉,腔静脉或体内的任何其它管形结构,以施行所说的分流。
图6根据本发明的一个优选实施方案,表示经过一个吻合通道3305连接两个左右相邻的血管以绕过一个狭窄部分的操作。移植物3300,它可以是人工的或生物学的区段或是由附近的区域移植的血管,可以利用探头3301朝向血管3307放置,其布局如图4和5所示。随后移植物3300可以使用一种连接方式例如外科粘合剂3309固定就位。可以采用例如固定缝合,基于能量的熔合,胶连,或磁力等连接方式使血管保持并列。在这里所讨论的在左右相邻的操作中使用一个人工的或生物学的区段,或由在附近的区域移植的血管作为分流管道,所以移植物3300的一端或两端可以用一个夹子3303终止以防止经其流过的血液的泄漏。通过一个导线3306,引入一个连接投送装置3302至移植物3300和血管3307之间的联结3308以在其上配置一个连接部件。一种可用于这一目的的连接部件为一个具有苜蓿叶形状的吻合斯滕特固定模3304,在1996年10月11日提出的共同未决的美国专利申请系列No.08/730,327中陈述了对其完整的描述,同时该申请要求对早先提出申请的临时申请系列No.60/005,164的优先权。另外,可以采用其它管道连接器装置,例如在PCT国际专利申请No._________,题为“用于连接在相邻的血管或其它解剖学结构上形成的开口的方法与装置”中所描述的,该申请是与本申请同时提出的。
如图6a所示,解剖学斯滕特固定模3304或其它连接器装置被用以在血管3307的腔和移植物3300的腔之间提供一个外部进入的连接。另外,斯滕特固定模3304是用以使血管3307和移植物3300保持紧密的靠近和维持解剖学通道3305的大小。然而,应该了解,用以保持解剖学通道大小的连接部件(即,解剖学斯滕特固定模)可以有许多装置,例如一个卡钉器,一个内部夹持器,一个斯滕特固定模,或一个熔合器。
图7和8表示为一个冠状血管或周边的动脉血管原位进行分流的操作。在一种原位分流操作中,血管3405和3406(其中一个需要分流)自然地彼此紧密地贴近,而不是拉到这一位置上的。如图7所示,导引器3400开始时由入口3409插入,经过体壁3108进入相邻血管3405和3406中的一个。随后一个进入导管3401通过导引器3400引入并进行操作使其端部3404穿入一个血管,例如血管3406中的适当的位置。在本发明的一个实施方案中,进入导管3401包括一个套节3402,套节带有许多入口3403以便于引入或移出例如各种装置,能量发送装置,或液体和气体。
图8更进一步详细地描述导引器3400和在需要分流的血管3502中的进入导管3501。图中示出了类似于图2中的导管5的进入导管3501,具有一个可供选择的气囊3503,被动探测装置3504,主动探测装置3505,外套3506和导线3507和35009。在此图中,导线3509代替了图2中所示的TVIS进入探头27。关于在这里讨论的原位分流操作基本上和就图4和5所陈述的操作相似。特别是,开始时进入一个血管是由内窥镜完成的。再有,一个靠近的平行血管的隔离,和经皮操作以形成一个解剖学的连接,和连接血管都是以非常相似的方法处理的。其基本的不同在于原位操作的情况下,将一个天然相邻的血管而不是一个人工的或生物学的分流区段作为分流管道,另外,在原位操作中,使用主动探测装置放置分流血管可能危险得多,特别是内窥组件没有配备荧光镜的情况。
图9表示在左右相邻情况下用原位分流或移植物区段分流操作的最后结果。在该操作中,由于内窥进入很容易,腔内阻塞防止分流的需要不限于使用类似于形成栓塞装置的器具(以下将就此进行讨论)。作为代替,血管3609的两端可利用图示的平行缝合3607予以封闭。平行缝合3607也可用以隔离血管3609中带有一个孔3608的部分,此前其中曾放置过导引器。如前所述,在使用人工的或生物学的移植物区段进行分流操作时,导引器可以另一种方式直接放入移植物3609的端部,而不是通过侧孔3608。如图9所述,通过将一个分流血管3609左右相邻地连接在带有病变部分3604的血管3600上,可以利用例如一个如上所述的可膨胀的气囊,切割和曝光,或内窥配件形成一个很小的组织通道例如吻合管道3602。吻合管道3602的形成可使液体由血管3600在绕过病变部分3604的近端部位流入分流血管3609。如果需要,可以在病变部分3604的下游形成另一个吻合管道3602,使液体绕病变部分3604流动并在远端部位回流进入血管3600。采用一个吻合装置3603以保持管道3602并使两个血管维持靠近状态。可以用上述的其它连接装置使血管保持靠近,或通过熔合使血管彼此相贴。
在绕过狭窄部分经皮形成吻合通道以后,为防止液体例如冠状血液通过分流血管直接流回,需在分流血管内的一处或多处封堵血流。现在参照图10所示的冠状分流术,在心静脉3内形成一个孔,并认定其具有足够的大小以后,一个栓塞装置例如一个栓塞气囊33可用以在心静脉3中吻合管道36近端范围阻塞血流。此项操作保证了冠状动脉血流34穿过吻合管道36并产生如箭头35a和35b所示逆向的心静脉血流。栓塞气囊33是利用栓塞导管31放入的,适当充气后可由一个可分离的区段32脱离。许多装置和材料都适用于栓塞目的。这些装置和材料包括可分离的气囊,线圈,可产生凝结的材料的绞线,微纤维的胶原蛋白,胶原蛋白海绵体,纤维素凝胶或海绵体例如Gelfoam,或特殊的斯滕特固定模。图10示出了这些装置如何用来使静脉系统在连接处的远端再-动脉化。然而,如图12所示,可以通过施行同样的操作在一个适当的下游部位简单地提供一个返回的分流通道。需要说明的是,这些栓塞装置也可用于阻塞任何不希望有的由心静脉分出的支流血管。图4和9将随后在本文中描述。
图11a-11b和12a-12b为根据本发明的栓塞装置的另外的两种形式,该装置也可用以实施所需要的封闭。这些栓塞装置,以及其它的装置,在题为“用于阻塞通过血管的血流的方法和装置”的PCT国际专利申请No._________中进行了描述,该申请是与本申请同时提出申请的。
图11a中所示的栓塞装置为一种放置在一个外套102中的压缩的胶原蛋白海绵体,该装置能够通过导线51进行投送。在导线51进入欲栓塞的血管以后,外套102经内芯103拉出以使胶原蛋白海绵体101在血管中膨胀,如图11b所示。在完成投送以后,导线51和导管组件102和103被拉出,将海绵体留在原位。
图12a和12b表示一个单向阀斯滕特固定模112。放置在斯滕特固定模112中的薄膜111在116一侧为圆柱形,在113一侧再折叠在其自身上以形成一个单向阀。如图12b的纵剖面图所示的,这将允许在箭头114方向的流动和装置在该方向前进,而阻止在箭头115方向的流动以及装置由该方向进入。单向阀斯滕特固定模112可以很容易地经导管置入所需要的位置上并膨胀固定就位。在内投送导管移出以后,薄膜111即可折叠并迅速形成一个阀样作用。
应该了解,所使用的如图11a和11b所示的胶原蛋白海绵体101,或如图12a和12b所示的血流阻塞或部分血流阻塞斯滕特固定模112,不是用以阻塞通过分流血管的正常血流的仅有的装置。实际上,某些用于在腔内焊接或封闭血管腔的能量发射装置和系统(这些装置最初示于临时申请系列No.60/010,614的图37-40中,本申请要求对该临时申请的优先权)以及其它阻塞器或腔阻塞装置现在都在题为“阻塞通过血管的流动的方法和装置”的共同未决的申请No.________中进行了描述并为其权利要求的范围,该申请与本申请同时提出,同时也要求对临时申请系列No.60/010,614的优先权。图15表示利用这里所描述的任何一种操作所形成的吻合通道36如何能够被一个以使吻合通道36具有足够宽度以接受血流为目的的经导线51前进的标准气囊52所扩张。再有,该步骤需要在插入其它装置之前将吻合通道36适当地做成所需要的尺寸,所说的其它装置例如图13所示的凸出的斯滕特固定模41,或图13a所示的非-凸出的斯滕特固定模410。
在某些情况下,如果在冠状动脉2和心静脉3之间可以有足够的材料被切除或被烧蚀,就不需要用一个斯滕特固定模保持吻合通道的大小。在图16中,表示一个气化导管63通过导线51在前进。在这里,能量61通过气化导管63的远端62被发送到吻合通道36以在动脉和静脉之间形成一个适当尺寸的连接。熟悉此项技术的人可以看出该气化导管63也可通过一些装置用以发送热,切割,焊接或凝结的能量,所说的一些装置并非限制地包括激光,双极或单极射频(RF),微波,超声,热线,或辐射。该气化导管63以及其它可用以将一个初始形成的刺穿管道或其它通道扩大,调整或再胀大的装置,在1996年10月11日提出申请的共同未决的美国专利申请系列No.08/730,327和08/730,496中进行了充分的描述并为其权利要求的范围。
在需要或要求使用通道的斯滕特固定模以保持通道所需尺寸的情况下,例如图13和14所示的那些斯滕特固定模可以置入吻合通道36内以控制其尺寸,例如,防止通道36在压力下膨胀,因周围组织的收缩而狭窄,或因再狭窄而封闭。
图18示出在加热和改形处理的过程中永久性地或暂时地保持吻合通道36的尺寸的另一种方法。其中示出了一个覆盖在吻合通道36的壁上的聚合物斯滕特固定模71。该聚合物斯滕特固定模71可以用一个气囊导管以插入和膨胀的方式置入,或利用此项技术中所熟知的各种方法在原地形成并为位于马萨诸塞的名为FOCAL(TM)的厂家所实施。该聚合物斯滕特固定模71可临时地防止再狭窄的效应或假动脉瘤的形成,并可在一段时间以后溶解,以减小任何长期组织反作用的效应的可能性。
在某些情况下,由于类似诸如再狭窄或假动脉瘤等问题可能会发生,就不需要造成一个吻合通道。然而,使用通道连接方法和诸如在图17,19,19a,19b,19c,20和20a所示的方法可减少或克服掉这些问题的影响。这些装置和其它通道连接或夹持装置在此前在1996年10月11日提出申请的美国专利申请Nos.08/730,327和08/730,496以及与本申请同时提出申请并要求对临时申请系列No.60/010,614的优先权的题为“用于解剖学通道吻合术的方法和装置”的PCT国际专利申请No.___________中都进行了更为充分的描述并为其权利要求的范围。
在图17中,一个焊接导管系统被用于在相邻的血管上形成的开口之间构成一个牢固的连接。该焊接导管系统包括一个近端焊接导管81和一个远端焊接导管86。在存在于心静脉3和冠状动脉2之间的间质空间29上形成吻合通道以后,一个导线51通过通道插入。随后远端焊接导管85通过导线51前进而贴近远端的气囊89被膨胀。然后,近端焊接导管81前进到越过远端焊接导管86。这时,贴近近端的气囊82被膨胀,两个气囊被拉进冠状动脉2和心静脉3上的开口相对的侧边。贴近的气囊和焊接导管可配备以如下的一个或多个部件:内部焊接电极83,对侧的焊接表面87和88,和返回电极85和84和热电偶801。在该情况下,可利用双极射频能量同时焊接两个血管的开口而不需要附加的机械配件装置。能量可送到每一个对侧的焊接表面87和88或者在内部焊接电极83与返回电极85和84之间。在每一种情况下,两个开口中和周围贴近的局部组织的温度上升至由热电偶801量测到的所需的温度。该温度维持一定的时间,在该时间内组织被熔合。熔合以后,关闭能源,排空气囊,移出装置,留下两个绕其周边被熔合的开口。
在图19中描述了一种机械地连接两个血管开口的卡钉方法。卡钉导管91具有外套96,可选择的加热线圈94和97,卡钉95,和微型机械卡钉夹持器93。卡钉导管91通过吻合通道36前进直到装置正确定位于冠状动脉2。外套96的外径的大小可使两个血管之间的吻合通道36略有扩张。在卡钉95的整个上半部完全放置好以后拉回外套96。拉回的时机由导管的近端处控制。卡钉95由弹簧类材料例如不锈钢或超弹性合金构成,以便其能够弯成如图19a所示的曲线位置。这一效果也可以利用形状记忆材料例如镍钛诺和通过线圈97加热来实现。在卡钉95的上半成为其曲线状态以后,如图18b所示卡钉导管91可以拉出,使卡钉95的顶部固定在冠状动脉2上开口的周边内。现在外套96可以完全抽出(如图19b所示),使卡钉95的下半部固定在环绕心静脉开口周边的内侧。再有,这一效果可以被动地在脱开外套时完成,或主动地利用来自加热线圈94的热量实现。尽管被动的方式很简单,但主动的方式可以利用注入冷盐水的方法使装置反转。这在卡钉95未能正确地固定时可能是需要的。最后,在确保卡钉就位以后,可利用微型机械卡钉夹持器93将其松开成为图18c所示的形状,其中卡钉95使组织36保持敞开的状态。熟悉此项技术的人可以看到,除使用微型机械以外,可以有许多方法使卡钉松开,这些方法包括热材料方法例如低温焊接熔化,一种夹持的聚合物或生物材料的温度降低,以及机械的方法例如移去夹持的导线,一个弱夹持材料的球形膨胀,或卡钉导管91相对于卡钉的松开动作,该动作只能在卡钉固定就位以后进行。与该卡钉导管91和卡钉95相似的装置在1996年10月11日提出的共同未决的美国专利申请系列No.08/730,327中进行了描述,示于其中的图9f一9f''',并为其申请的权利要求的范围。
图20-20a表示用以将相邻血管上形成的开口夹持在一起的一种装置的另一个实施方案。该实施方案使用一个通过导线2206插入的远端导引导管2205。一个上夹头2204通过一个位于上夹头2204附近的可压缩的夹持单元2207固定在远端导引导管2205上。该组件穿过吻合通道36前进直到完全通过。这时,由于上夹头2204的尺寸略大于吻合通道36的直径,可压缩的夹持单元2207将帮助扩大吻合通道36。一个近端导引导管2201连同一个位于其顶部的下夹头2202通过远端导引导管2201朝着吻合通道36前进。两个夹头2204和2202随后被拉而彼此靠近,直到上夹头2204的齿2208穿进并锁入位于下夹头2202上的接收孔2209内。在成功地锁定以后,可压缩的夹持单元2207被压缩而近端和远端导管均被拉出将夹头留在后面,如图22a所示。可压缩的夹持单元例如可以是一个气囊,由形状记忆材料制成的支杆,或由导管近端控制的线材销。类似于图20-20a所示的通道连接装置在1996年10月11日提出的共同未决的申请系列第08/730,327号中进行了描述并示于其中的图9a-9a’,这些装置均为其权利要求的范围。
图21示出了根据本发明的一个实施方案的另一种焊接装置。其中采用了与可见于图17中的很相似的方式,但能量是由一个中央发射芯体2301释放到血管2和3相对的开口上。在这种情况下,在两个开口对置好以后,通过气囊89和81,一个中央发射芯体进入导管组件81和86的中央直到吻合通道36的中点。能量由该中央发射芯体发出,在围绕装置周围的局部组织产生足够的温度以使其熔合。该能量及其发射器可以是360度地侧向发射的激光纤维,微波或其它电磁天线,或是局部地连接着的产生超声的压电晶体或激光发射器。热电偶801也有助于确定和控制焊接过程。
图22表示在完成冠状分流操作以后的最后结果。正常的冠状血流34被分流绕过狭窄部分201,通过吻合通道1202进入心静脉3并通过吻合通道1203回到冠状动脉2。图中示出了一个阻塞上游和下游心静脉3以及一个分支静脉1204的通常的栓塞装置1201。在需要简单的心静脉动脉化的情况下,仅要求近端的栓塞和附件。
图23a和23b表示一个综合的TVIS进入部分1301。TVIS部分具有一个外壳130和一个进入的入口138,该入口可用以引入各种器具。进入的入口138还具有在单独位于导管内或在有器具经其插入的情况下保持压力或止血的能力。导管133具有一个形成外壳130的近端部分和一个形成端部1302的远端部分。TVIS进入部分1301还可具有一个成象的标识139和一个位于其远端的稳定气囊134。在图5所示的TVIS导引导管5进入间质并在其后留下一个导线以后,TVIS进入部分1301的远端端部经皮沿导线放入并进到间质空间138。在由血管132外确认标识139以后,使气囊134膨胀。熟悉此项技术的人可以看出,位于端部的稳定装置还可包括锁定线材,可膨胀的网,和类似构架的可膨胀的斯滕特固定模。在TVIS进入部分固定就位以后,许多其它装置可插入以进行医学的或治疗的介入。这些装置包括内窥镜135,外科工具136例如针,插管,导管剪,抓紧器,或活检装置,和能量发送装置137例如激光纤维,双极和单极射频导线,微波天线,射线发送装置,和热发送装置。在放置一个或多个TVIS进入部分1301以后,即可通过周边组织中的血管系统完整地实施各种外科操作。
图24表示根据本发明的TVIS导引导管146的另一个实施方案。图中示出了一个具有可以活动地弯曲的远端端部145的TVIS导引导管146。这时,远端端部145因嵌入在远端端部145中的形状记忆材料142而发生弯曲。当该材料由加热线圈147加热时,材料迅速弯曲成为所需要的形状。配置了一个工作通道143用于所需的TVIS装置的进入。图中示出了一个针141向血管周围的组织注入药物140。如前面所讨论的,TVIS导引导管146还可包括一个用以在血管中保持稳定的气囊144,和一个被动成象标记148。
图25表示相同的TVIS导管146,该导管带有一个如前所述的主动成象装置23的附件。在图25中还示出了在远端端部145中工作通道143内的TVIS探头27和TVIS外套26。另外,还示出了一个冲洗通道150。
图26表示根据本发明的一个实施方案形成具有精确大小的吻合通道36的另一种方法。一个反向组织切割导管组件173通过导线51经由吻合通道36前进。反向组织切割组件173具有一个连接在膨胀的端部170上的圆柱形刀片171。端部170通过吻合通道36前进直到刀片171位于动脉2内开口的前方。在其位置被确定以后,一个较大的基座导管172朝着静脉3内的近端开口前进。刀片171和端部170随后朝着吻合通道36的边缘被拉回,当其压向基座导管172时截取了圆柱形刀片171内的组织。在组件173移走以后,所得的吻合通道36的尺寸为圆柱形刀片171的外径。在1996年10月11日提出的美国专利申请系列No.08/730,327中描述了一种相似的反向组织切割组件,示于其中的图8f中,并为其权利要求的范围。
图27为根据本发明的一个实施方案的TVIS导引导管182,其中一个远端气囊181和一个近端气囊180隔离出一段需进行穿刺的动脉。这对在高压血管例如一个动脉中使用TVIS导引导管182是有效的。这样一种导管182可以与图2所示的导管5相同的形式应用。
在图28a和28b中描述了根据本发明用以分流一段血管的实施方案的另一种可供选择的方法。图28a描述了诸如在图14和15中所示的一种TVIS导引导管146,但在这里导管具有一个可主动控制的形状记忆材料142的远端端部145。图中示出了TVIS导引导管146本身,导管正利用探头27和外套26引导在周围的组织中开通通道。最后,导管145形成一个可以如图28b所示的能使血流由动脉2中的一处流向另一处的通道190。
图29a-29d表示根据本发明的一个实施方案将一个形成-通道的导管用于经心肌的血管重建术。图29a表示TVIS导引导管5是如何能置入心室2001的。图中示出了TVIS探头27经心脏肌肉2000形成一个细长的通道2003。该通道可在心室和心肌2000内的小毛细血管床形成直接的联系。图29b表示图29a所示的另一种TVIS导引导管146如何在心脏中形成这种细长通道2003的。这时TVIS导引导管145进一步修改成带有气囊的端部2002,以便在气化时覆盖通道2003;气囊2002还可通过导管146向气囊2002的远端处的开口提供抽吸以帮助固定在心室壁2004上。最后,图29c描述了TVIS导引导管5经血管形成许多通道2003的情况,以使血流由血管直接流入心脏。导引导管5可以使用射频,电能或机械能以形成小孔。
图29d和29d’表示另一种经心肌的血管重建术的操作,其中一种TVIS导引导管5,145和相应的TVIS探头27已经进入到冠状静脉CV并用以形成一系列经心肌的通道2003a,这些通道由冠状静脉CV的腔通过心肌壁MW延伸进入下面的左心室LV。在移走导引导管5或146和探头27以后,冠状静脉CV保持打开和不受阻塞,使充氧的血液可以由左心室LV通过经心肌的通道2003a进入冠状静脉CV的腔,并通过冠状静脉CV进入冠状窦。在这种情况下,基本上连续的充氧血流将可由左心室LV,经由经心肌的通道2003a和冠状静脉CV,给那些通道2003a附近的心肌区域提供基本上连续的灌注。
图30为可通过根据本发明的一个实施方案中的TVIS导管146前进的几种类型的装置的较详细的说明。图中示出一个线2501,该线具有一个沿其前进通过血管壁2504的扩张器2502和一个外套2503。
另外,如图31a和31b所示,例如图13所示的一种单独的外套可以被向前推进。开始,TVIS导管用以向组织内放置一个锁定导线2602。导线具有一个非常小的锁定结2604,其作用为在更换装置时将导线锚固在组织内。随后,通过锁定导线2602,图30a所示的TVIS入口导引器组件向前推进。组件包括一个在导管133内的扩张器2601。导管133配有一个稳定装置134,在这里例如一个气囊。在导管133就位后,同时稳定装置被展开,扩张器2601和锁定导线2602被移走。根据情况,外壳1301可以配备也可不配备阻止回流进入导管133的阀。随后,各种器具可以如前所述地插入导管133。
在图32a和32b中可以看到作为元件2704的根据本发明的另一个TVIS导管的实施方案。如图31a所示TVIS导管2704由预先-形成的曲线构成。当导管受到约束时,如图31b所示,其可以保持为直线的形状。可以看出在导管2704保持为直线时(图32b)导线2701可自导线腔2709引出,而当导管能够回到其预先-形成的形状时(图32b)导线由侧孔2702引出。所示的一个TVIS探头2703进入另一个通道并自装置顶部的任一位置上引出。导管2704可以与前述的其它导管一样地使用,但其优点是能够使端部弯成所需要的方向。
根据本发明的另一个TVIS导管2800的实施方案示于图33a。其中血管上的两个开口是由气化能量束2805形成而不是探头形成。该方法使用了一个能量导向装置2801,该装置在折射板2802上使能量成束,并将能量侧向地转送进入组织。持续的时间和能量的水平必须仔细地设定以保证血管2对侧的壁不受损害。图中还示出了可供选择的导线2804,该导线可用以阻断激光能量进入或为激光能量穿刺提供信号。
图33b表示根据本发明的一个实施方案的另一种拓宽或切割小孔的机构。其中装置通过组织通道经导线3003前进,通过外壳3004相对于中央主体3002的移动将切割翼3001展开。翼3001可以是锐利的,或用附加的能量在装置拉出通过组织的通道时用以拓宽小孔。
在图34a和34b中作为元件2900描述的是根据本发明的另一个实施方案的TVIS导管。如其中所示,导管2900包括一个沿其纵轴并终止于远端单个开口2902的通道2901。一个TVIS探头2903直线地放置在通道2901中。在一个优选实施方案中,TVIS探头2903,不是导管本身(图31a和31b),配置有形状记忆能力,在其离开通道2901以后,TVIS探头2903能够恢复其预先-形成的如图29b所示的曲线形状,随后穿过一个血管形成一个开口,该开口相对于导管2900的纵轴小于180度。一个导线2904也可移动地放置在探头2903内。为此目的,在探头2903由通道2901内通过开口2902移出并恢复其预先-形成的形状时,导线2904可在探头2903中前进并由相同的开口2902移出。为形成一个通道2905,优选地将导线2904略微地拉入探头2903内,从而使探头2903的远端部分2908暴露出来并刺穿血管2906跨入血管2907。在探头2903进入血管2907后,导线2904可由探头2903内前进并进入血管2907的腔。应该了解,尽管导管配有预先-形成的形状的探头2903,导管2900还是可以按前述其它导管的方式使用。
Claims (33)
1.一种用以分流哺乳类患者血管的一个阻塞区段的方法,所说的方法包括的步骤有:
a)提供一个管形分流移植物,该移植物具有至少一个端部和一个在其中沿纵向延伸的空腔;
b)将所说的移植物的一端放置在一个血管的并列的位置上,其端部位于梗阻部位的下游;
c)将一个形成-通道的探头装置插入分流移植物的腔内,所说的形成通道的探头装置包括一个细长的部件,该部件具有一个在其上形成的出口的开口和一个组织穿刺元件,该元件可穿出所说的出口的开口以刺穿分流移植物的壁和与所说的分流移植物的壁并列的组织;
d)将形成通道的探头装置置入分流移植物的腔内使探头装置的出口的开口邻近分流移植物欲与血管相连接的部位;
e)将探头装置的组织穿刺元件自出口的开口伸出,穿过分流移植物的壁,并穿过并列的血管的壁,从而在分流移植物和血管的壁上形成第一开口;
f)将分流移植物固定在血管上,使分流移植物的第一开口基本上与血管的第一开口对准,并使血液通过第一开口在分流移植物和血管之间流动。
2.根据权利要求1中所说的方法,其特征在于在步骤a中所提供的管形分流移植物是患者的一个被横断的血管,因此形成一个第一横切端,并保持与其内源的血液供应相连系,所说的横切端为分流移植物的仅有的端部,而所说的第一开口为连接到所说的血管上的仅有的开口。
3.根据权利要求2中所说的方法,其特征在于该方法用来分流一个冠状动脉,且其中所说的分流移植物为患者体内的乳房动脉。
4.根据权利要求1中所说的方法,其特征在于在步骤a中所提供的分流移植物为具有第一和第二端部的管状移植物。
5.根据权利要求4中所说的方法,其特征在于所说的管状移植物是一个生物学的移植物。
6.根据权利要求4中所说的方法,其特征在于所说的管状移植物是一个合成的移植物。
7.根据权利要求4中所说的方法,其特征在于管形分流移植物的第一端在方法的步骤b中与血管并置,且其中所说的方法还包括另外的步骤:
g)将分流移植物的第二端放置在与一个血管并置的位置上;
h)重新将形成-通道的探头装置放入分流移植物的腔内,使探头装置的出口的开口位于靠近需在所说的分流移植物和一个血管之间形成第二连接的地方;
i)将探头装置的组织穿刺元件穿出出口的开口,穿过分流移植物的壁和并置血管的壁,从而在分流移植物和血管上形成第二开口;
j)将分流移植物固定在血管上,使分流移植物中的第二开口基本上和血管上的第二开口对准并使血液通过第二开口在分流移植物和血管之间流动。
8.根据权利要求1中所说的方法,其特征在于分流移植物中的所说的第一开口是一个侧开口,且其方法还包括的步骤有:
封闭分流移植物的任何开口端以防止血液由所说的分流移植物中漏出。
9.根据权利要求8中所说的方法,其特征在于所说的分流移植物的至少一个端部采用由封闭装置组群中选择的一种封闭装置进行封闭,该组群包括:
一种结扎线;
一种卡钉;
一种夹子;
一种塞子;
一种盖帽;
一种腔阻塞装置;
一定数量的粘合剂;和
一定数量的凝胶。
10.根据权利要求1中所说的方法,其特征在于步骤f是由连接装置组群中选择的一种连接装置完成的,该组群包括:
粘结剂;
缝合;
基于能量的焊接;
凝胶;
至少一块磁铁;和
一个连接器装置,该装置可置入在所说的血管和所说的分流移植物上形成的第一开口内。
11.根据权利要求7中所说的方法,其特征在于方法的步骤f和j是由连接装置组群中选择的一种连接装置完成的,该组群包括:
粘结剂;
缝合;
基于能量的焊接;
凝胶;
至少一块磁铁;和
一个连接器装置,该装置可置入在所说的血管和所说的分流移植物上形成的第一和第二开口内。
12.根据权利要求1中所说的方法,其特征在于一个开口在分流移植物的侧面形成以使所说的形成-通道的探头从中通过,且其中所说的方法还包括的步骤有:
在形成-通道的探头移走以后封闭分流移植物侧面的开口。
13.根据权利要求1中所说的方法,其特征在于形成-通道的探头是通过分流移植物上的侧向分支插入的,且其中的方法还包括的步骤有:
在形成-通道的探头移走以后封闭分流移植物上的侧向分支。
14.一种焊接导管系统,该系统被用以利用在相邻位置上的第一和第二解剖学结构的壁上形成的开口,使液体可由所说的解剖学结构中的一个通过所说的开口流入所说的解剖学结构中的另一个,所说的焊接导管系统包括:
一个具有一个近端,一个远端的细长的导管主体,所说的细长的导管主体可穿过所说的解剖学结构上形成的所说的开口;
在导管的第一部位上形成的一个第一逼近部件;
在导管的第二部位上形成的靠近所说的第一部位的一个第二逼近部件;
组织熔化的装置,用以熔化在第一和第二逼近部件之间的组织;
所说的第一和第二逼近部件是可操作地将所说的开口彼此压向一起,所说的组织熔化装置可同时启动,将所说的第一和第二开口以及位于其间的任何组织熔化。
15.根据权利要求14中所说的焊接导管系统,其特征在于所说的第一逼近部件是一个气囊。
16.根据权利要求14中所说的焊接导管系统,其特征在于所说的第二逼近部件是一个气囊。
17.根据权利要求14中所说的焊接导管系统,其特征在于所说的组织熔化装置是一个能量发射装置,该装置适合于发射的能量类型是由以下能量类型组群中选择的:
热;
激光;
电流;
射频能量;和
超声。
18.根据权利要求14中所说的焊接导管系统,其特征在于组织熔化装置是一种使用粘结剂的装置,该装置可操作地在所说的第一和第二开口附近及二者之间的组织施用粘结剂。
19.根据权利要求14中所说的焊接导管系统,其特征在于所说的组织熔化装置是一个化学制品发送装置,该装置可操作地向所说的第一和第二开口附近及二者之间的组织发送一种使组织熔化的化学制品。
20.一种经心肌的血管重建的方法,所说的方法包括的步骤有:
a)在冠状静脉和心脏的一个腔室之间形成至少一个经心肌的通道,使血液由该心脏的腔室流经所说的通道进入所说的冠状静脉。
21.根据权利要求20中所说的方法,还包括的步骤有:
b)使冠状静脉的腔保持为不阻塞以使静脉血继续经所说的冠状静脉的腔流动。
22.根据权利要求20中所说的方法,其特征在于步骤a包括在所说的冠状静脉和所说的心脏的腔室之间形成许多所说的经心肌的通道。
23.根据权利要求20中所说的方法,其特征在于心脏的腔室为左心室。
24.根据权利要求20中所说的方法,其特征在于步骤a是由经腔前进进入所说的冠状静脉的一个形成通道的导管完成的,导管上带有一个穿过所说的导管的组织穿刺元件,导管穿过所说的冠状静脉的壁并通过心肌,从而形成所说的至少一个经心肌的通道。
25.根据权利要求1中所说的方法,其特征在于方法的步骤e包括使组织穿刺部件由出口的开口穿出,通过分流移植物的壁和并置的血管的壁。
26.根据权利要求25中所说的方法,其特征在于所说的组织穿刺部件具有一个沿其延伸的导线腔,且其中的步骤e还包括:
将导线自组织穿刺部件的腔穿过并进入血管,使导线在组织穿刺部件缩回到探头内时仍保留在血管内。
27.根据权利要求1中所说的方法,其特征在于步骤e包括由探头传递组织穿刺的能量流,穿过分流移植物的壁和并置的血管的壁。
28.根据权利要求7中所说的方法,其特征在于方法的步骤ⅰ包括使一个组织穿刺部件自出口的开口穿出,通过分流移植物的壁和并置的血管的壁。
29.根据权利要求28中所说的方法,其特征在于所说的部件带有一个沿其延伸的导线腔,且其中的步骤ⅰ还包括:
使导线穿过组织穿刺部件的腔并进入血管,使所说的导线在组织穿刺部件缩回探头内时仍保留在血管内。
30.根据权利要求7中所说的方法,其特征在于步骤ⅰ包括由探头传递一种组织穿刺的能量流穿过分流移植物的壁和并置的血管的壁。
31.根据权利要求24中所说的方法,其特征在于穿刺元件包括一个由出口的开口穿出的部件,该部件穿过分流移植物的壁,并穿过并置的血管的壁。
32.根据权利要求31中所说的方法,其特征在于所说的部件具有一个沿其延伸的导线腔,且其中的方法还包括:
使导线穿过组织穿刺部件的腔并进入血管,使所说的导线在组织穿刺部件缩回探头内时仍保留在血管内。
33.根据权利要求24中所说的方法,其特征在于所说的组织穿刺元件包括一种能量流,该能量流由所说的导管穿过分流移植物的壁并穿过并置的血管的壁。
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US1061496P | 1996-02-02 | 1996-02-02 | |
US60/010,614 | 1996-02-02 |
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CN97193556A Pending CN1216930A (zh) | 1996-02-02 | 1997-01-31 | 间质经血管介入的装置,系统和方法 |
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US (2) | US6579311B1 (zh) |
JP (1) | JP2001508318A (zh) |
CN (1) | CN1216930A (zh) |
AT (1) | ATE247429T1 (zh) |
AU (1) | AU733341B2 (zh) |
CA (1) | CA2244066A1 (zh) |
DE (1) | DE69724255T2 (zh) |
ES (1) | ES2206684T3 (zh) |
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- 1997-01-31 AT AT97904081T patent/ATE247429T1/de not_active IP Right Cessation
- 1997-01-31 US US09/117,515 patent/US6579311B1/en not_active Expired - Lifetime
- 1997-01-31 WO PCT/US1997/001459 patent/WO1997027897A1/en active IP Right Grant
- 1997-01-31 DE DE69724255T patent/DE69724255T2/de not_active Expired - Lifetime
- 1997-01-31 ES ES97904081T patent/ES2206684T3/es not_active Expired - Lifetime
- 1997-01-31 CA CA002244066A patent/CA2244066A1/en not_active Abandoned
- 1997-01-31 CN CN97193556A patent/CN1216930A/zh active Pending
- 1997-01-31 IL IL12541597A patent/IL125415A/en not_active IP Right Cessation
- 1997-01-31 JP JP52780497A patent/JP2001508318A/ja active Pending
- 1997-01-31 AU AU18471/97A patent/AU733341B2/en not_active Ceased
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2003
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Cited By (6)
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CN100346750C (zh) * | 2002-06-19 | 2007-11-07 | 塞隆医疗设备公司 | 电极针 |
CN102395327A (zh) * | 2009-02-25 | 2012-03-28 | 飞利浦电子有限公司 | 用于经颈静脉肝内门体静脉分流(tips)程序的方法、系统以及设备 |
CN102395327B (zh) * | 2009-02-25 | 2014-09-24 | 飞利浦电子有限公司 | 用于经颈静脉肝内门体静脉分流(tips)程序的方法、系统以及设备 |
CN114042224A (zh) * | 2016-01-15 | 2022-02-15 | Tva医疗公司 | 用于推进金属丝的装置和方法 |
CN109465258A (zh) * | 2019-01-11 | 2019-03-15 | 杭州成威物业管理有限公司 | 一种曲线管道内壁异物收缩夹取清除装置 |
CN109465258B (zh) * | 2019-01-11 | 2024-03-01 | 重庆能源职业学院 | 一种曲线管道内壁异物收缩夹取清除装置 |
Also Published As
Publication number | Publication date |
---|---|
CA2244066A1 (en) | 1997-08-07 |
IL125415A (en) | 2004-02-19 |
WO1997027897A1 (en) | 1997-08-07 |
DE69724255D1 (de) | 2003-09-25 |
ES2206684T3 (es) | 2004-05-16 |
US20040073238A1 (en) | 2004-04-15 |
IL125415A0 (en) | 1999-03-12 |
AU1847197A (en) | 1997-08-22 |
US6579311B1 (en) | 2003-06-17 |
JP2001508318A (ja) | 2001-06-26 |
US8075580B2 (en) | 2011-12-13 |
ATE247429T1 (de) | 2003-09-15 |
AU733341B2 (en) | 2001-05-10 |
DE69724255T2 (de) | 2004-06-03 |
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