CN102215780B - 部分压接支架 - Google Patents
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- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
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Abstract
一种将支架压接在多个导管上的压接方法。该方法包括将支架有差别地压接在气囊导管的特定部分上，使得次级导管能螺旋通过支架的非压接部分，并通过传统支架设计的连结或者通过支架中为分支脉管所设计的特定孔而离开。
Description
相关申请的交叉引用
2008年9月25日提交的美国临时专利申请号61/194346，在此以参见的方式引入其全文。
背景技术
本发明涉及医疗支架的领域，更具体地说涉及用于治疗脉杈中或附近的损伤或其它问题的医疗支架。支架是内镜置管架子或者是通常放置在管腔内或植入静脉、动脉或其它管状身体器官内的其它装置，此种装置通过使脉管膨胀或通过使脉管壁加强来对阻塞、狭窄、动脉瘤、塌陷、解剖或衰弱、病变或异常胀大的脉管或脉管壁进行治疗。具体地说，支架被相当普遍地植入冠状系统、心脏系统、肺系统、神经和血管系统、外围血管系统、肾系统、肠胃系统以及生殖系统，并且已成功植入尿管、胆管、食道、气管支气管树以及大脑中，以使这些身体器官加强。目前，支架的两个重要普遍应用是：通过防止脉管壁弹性回弹并对脉管壁进行重新塑形来改进血管成形术的效果，以及通过将解剖位置处的内腔中的内膜瓣压在一起，来对由冠状动脉以及外围动脉进行气囊血管成形术所引起的血管壁进行解剖。传统的支架已用于治疗更复杂的血管问题，例如血管系统中的分叉位置处或附近的损伤，在此次级动脉从通常较大的主动脉中分支出来，而这具有有限的成功率。
传统的支架技术相对来说发展良好。传统的支架设计通常特征在于沿纵向轴线反复贯穿平移的、直管状、单个类型的胞室结构、构造或型式。在许多支架设计中，重复结构、构造或型式具有支柱和阻碍分叉处血流的连接气囊导管部分。此外，支柱和连接气囊导管部分的构造可阻碍后操作装置的使用，以对脉管分叉区域中的子系脉管进行治疗。例如，在由于移位病变组织（例如，由于斑块移动或“扫雪”）、闭塞、脉管痉挛、与内膜瓣脱开或不具有内膜瓣、血栓形成、栓塞和/或其它血管病而使母系脉管的治疗是次佳的情形中，在母系内腔中展开第一支架可防止外科医生通过脉管分叉的子系脉管的小孔插入子系支架。
鉴于不一致地考虑覆盖相对通达而设计常规支架。例如，为了促进覆盖，支架的胞室结构尺寸可最小，以较佳地支承脉管壁，由此防止或减小组织脱垂。为了有利于通达，胞室尺寸可最大，从而为血流和将来可能植入子系脉管的子系支架提供可通达性，由此防止“支架监禁”，并且使所要植入的材料量最小。常规的支架设计通常使一种考虑因素对于另一种考虑因素折衷，以试图实现两种情况。目前的发明家所观察到的问题包括：子系监禁、斑块移动的担忧、完全闭塞，而治疗的困难持续驱使目前的发明家发展新颖的输送系统，而新颖的输送系统更容易、安全且更可靠地被适用，以治疗上述各种血管疾病。
虽然传统支架例行地用在临床治疗中，临床数据示出这些支架并不能够完全防止支架中再狭窄（ISR）或内膜增生所引起的再狭窄。支架中再狭窄是支架植入之后由支架所覆盖的区域中的动脉再次发生狭窄或堵塞。采用管状支架治疗的患者会遭受支架中再狭窄。
已进行很多药理学尝试以减小由内膜增生所引起的再狭窄量。许多这些尝试已通过口腔或血管内注射来进行药物的全身输送。然而，全身通达的成功性具有局限性。
药物的全身输送具有固有局限性，这是由于难于对痛苦区域实现恒定的药物输送，并由于全身分配药物通常循环通过浓度峰值和低谷，产生中毒和无效的时间段。因此，为了有效，应以局部方式输送抗再狭窄药物。
一种用于局部药物输送的方法将支架用作输送工具。例如，装载有表示细菌贝它半乳糖激酶或人类组织类型的纤维蛋白溶酶原活化因子的支架用作治疗蛋白质输送工具。例如，参见Dichek,D.A等人发表于Circulation,80:1347-1353(1989)的“Seeding of Intravascular Stents With Genetically EngineeredEndothelial Cells”。
题为“Intraluminal Drug Eluting Prosthesis”的美国专利号5679400、国际专利申请WO91/12779和题为“Stent With Sustained Drug Delivery”的国际专利申请WO90/13332披露如下支架装置：该支架装置能够输送抗血小板剂、抗凝剂、抗迁移试剂、抗代谢剂以及其它抗再狭窄药物。
美国专利号6273913、6383215、6258121、6231600、5837008、5824048、5679400以及5609629描述涂覆有诸如雷帕霉素、17-贝它-雌二醇、紫杉醇以及地塞米松之类的各种药物试剂的支架。该参考专利和所有其它参考专利全部以参见的方式纳入本文。此外，在以参见方式纳入本文的参考术语的定义或使用与本文提供的术语定义不一致或相反的情形下，本文提供的术语定义适用，而参考术语的定义不适用。
发明内容
本发明涉及用于输送支架的输送导管，以将支架放置在脉管分叉处，并且输送导管大体构造成至少部分地覆盖子系脉管以及母系脉管的一部分。本发明包括有差别地压接支架的支架压接方法，以考虑到诸如并不具有均匀壁的锥形支架之类的支架设计元件。此外，对于安装在两个导管上的支架可应用不同压接。
附图说明
在此参照附图仅以示例的方式描述本发明。现在具体参照附图，应强调的是借助示例、并且仅仅为了对本发明的较佳实施例进行说明性描述而示出特定方面，且给出所示的特定方面以提供被认为是本发明的原理和概念方面最有用且最容易理解的描述。在此点上，并不试图比基础理解本发明所需更详细地示出本发明的结构细节，利用这些附图所进行的描述使那些本领域技术人员对如何实际实施本发明显而易见。
附图中：
图1是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有快速交换设计。
图2是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有快速交换设计。
图3示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计。
图4示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计。
图5是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有快速交换设计和捕获管。
图6是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有快速交换设计和捕获管。
图7示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计和捕获管。
图8示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计和捕获管。
图9是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有快速交换设计和可拆除捕获管。
图10是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有快速交换设计和可拆除捕获管。
图11示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计和捕获管。
图12示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计和捕获管。
图13是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有快速交换设计和短拉链。
图14是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有快速交换设计和短拉链。
图15示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计和短拉链。
图16示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计和短拉链。
图17是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有快速交换设计和端对端拉链。
图18是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有快速交换设计和端对端拉链。
图19示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计和端对端拉链。
图20示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计和端对端拉链。
图21是一实施例的横断剖视图，其中母系导管具有线上设计，而子系导管具有带有市场上可买到导管的快速交换设计。
图22是一实施例的横断剖视图，其中子系导管具有线上设计，而母系导管具有带有市场上可买到导管的快速交换设计。
图23示出一实施例的横断剖视图，其中母系导管和子系导管都具有带有市场上可买到导管的快速交换设计。
图24示出一实施例的横断剖视图，其中母系导管和子系导管都具有带有市场上可买到导管的线上设计。
图25-30以八个步骤示出已较佳实施例的输送顺序。
图31是具有部分被压接的分叉支架的较佳实施例的照片。
图32是一较佳实施例的照片，其中分叉支架部分地压接有螺旋通过分叉支架孔的第二导管。
图33是一较佳实施例的照片，其中分叉支架部分地压接有螺旋通过分叉支架孔的第二导管。
图34是一较佳实施例的照片，其中该系统完全对准并完全被压接。
图35是两个导管上有差别压接支架的横断剖视图。
图36是安装在两个气囊导管上的支架的侧视图。
图37是安装在两个气囊导管上的支架的侧视图。
具体实施方式
本发明涉及用于输送支架的输送导管，以将支架放置在脉管分叉处，并且输送导管大体构造成至少部分地覆盖子系脉管以及母系脉管的一部分。具体地说，本发明涉及将支架压接于输送导管的新颖方法。
可使用各种导管设计，以将母系支架和子系支架展开和定位。可与终止于母系脉管和子系脉管中的多个导线结合来使用这些导管。可使用这些导线以便于引入导管、任何血管成形术气囊、任何支架和/或使支架或气囊在脉管内适当定向。
通常，本发明的方法可使用包括导管本体的导管系统，该导管本体具有母系脉管导线内腔和子系气囊，而该子系气囊可独立操作并联接于导管本体。子系气囊导管部分具有子系脉管导线内腔。导管系统还包括母系导管的气囊，且支架设置在该气囊上。子系导管延伸到母系支架的近侧开口中，并通过母系支架的侧部通道离开母系支架。
根据一方法，将母系脉管导线插到母系脉管中，直到母系脉管导线的远端通到子系脉管的小孔之外为止，并且将子系脉管导线插到母系脉管中，直到子系脉管导线的远端通到子系脉管中为止。为了防止导线交叉，两个脉管以线通过具有两个内腔的导线导管，以使这些导线保持分离和非缠结。然后拆除导线导管，并将隔线器放置在线上以使这些导线保持不缠绕。然后，导管系统在母系脉管导线和子系脉管导线上前进，使母系导管和子系导管在母系脉管导线和子系脉管导线上通过。导管系统在两条线上前进，而子系脉管气囊导管部分位于母系气囊导管部分远侧。当导管系统在线上前进时，子系气囊会进入子系脉管并且可马上展开或者在放入母系气囊之后与母系气囊同时展开。然后，导管系统的母系气囊导管部分朝远侧前进，远到其可前进至分叉位置处为止，而这是由于子系导管在母系支架上的张力会防止母系导管朝远侧运动。该方法使导管系统便于朝分叉处前进，而这对于迂曲或钙化冠状动脉是有必要的。一旦导管系统就位时，则相对于母系导管向后拉动子系气囊导管部分，使得该子系气囊导管部分部分地位于母系支架内，并且可利用不透性标记物来执行对准。然后，操作者可向远侧轻轻地推动导管系统，以最大限度相对于脊骨并置。然后，子系气囊膨胀以确保母系支架的合适对准。子系气囊还可在其远侧部分上具有支架，该支架会致使母系支架和子系支架的近侧部分同时膨胀。然后，子系气囊收缩。母系气囊则膨胀，使得母系支架展开。如果需要或者为了使斑块移动，使这两个气囊接触、重新膨胀。可在这些线保持就位的同时拆除导管系统。如果需要，子系脉管可由任何市场上可买到的支架所支持，例如不会覆盖整个子系气囊的短支架。在有时指示必需的预膨胀时，可对这两个脉管分别进行血管成形术。
在一替代方法中，母系导管可安装在子系脉管导线上，而子系导管可安装在母系脉管导线上。在具有高斜度（超过60-70％）的子系脉管中，当操作者在该构造中朝近侧拉拽子系支架并将该子系支架拉入母系支架中时，摩擦较低。导管系统前进，使得子系气囊导管可通过子系脉管的小孔并保持在母系脉管中。当导管系统进一步前进时，母系导管会进入子系脉管。导管系统能仅仅前进至分叉处，这是由于在母系脉管中的子系导管和母系导管上的母系支架之间存在张力，而该张力防止进一步前进。当母系导管保持就位时，往回拉拽子系导管，使得子系气囊的近侧部分位于母系支架中。利用不透性标记物来执行对准。然后，操作者可向远侧轻轻地推动导管系统，以最大限度相对于脊骨并置。对子系气囊上的支架进行对准，使得当子系气囊膨胀时，子系支架和母系支架的近侧部分同时膨胀并对母系脉管提供完全覆盖。然后，子系气囊收缩。然后，母系气囊膨胀，并且母系支架的远侧部分扩大。如果需要还可执行接触治疗。
在一替代实施例中，可使用该系统，用于对子系脉管进行临时支持。导管系统包括母系导管和子系导管，母系导管包括母系气囊和母系支架，而子系导管包括子系气囊，其中，母系导管装载在子系脉管导线上，而子系导管装载在母系脉管导线上。导管系统前进，使得子系导管可通过子系脉管的小孔并保持在母系脉管中。当导管系统进一步前进时，母系导管和母系支架会进入子系脉管。导管系统能仅仅前进至分叉处，这是由于在母系脉管中的子系导管和母系导管上的母系支架之间存在张力，而该张力防止进一步前进。当母系导管保持就位时，往回拉拽子系导管，使得子系气囊的近侧部分位于母系支架中。利用不透性标记物来执行对准。然后，操作者可向远侧轻轻地推动导管系统，以最大限度相对于脊骨并置。线上的气囊可用作对子系导管的替代。
在一替代实施例中，可使用该系统，用于对子系脉管进行临时支持。导管系统包括：母系导管和子系导管，母系导管包括母系气囊，而子系导管包括子系气囊和位于该子系气囊的远侧部分上的子系支架，其中，母系导管装载在母系脉管导线上，而子系导管装载在子系脉管导线上。导管系统在两条线上前进，而子系气囊导管部分位于母系气囊导管部分远侧。当导管系统前进至超出线时，子系导管会进入子系脉管。然后，导管系统的母系气囊导管部分朝远侧前进，远到其可前进至分叉处为止。一旦导管系统就位时，则相对于母系导管向后拉动子系气囊导管部分，使得该子系气囊导管部分部分地位于母系脉管内，并且可利用不透性标记物来执行对准。然后，操作者可向远侧轻轻地推动导管系统，以最大限度相对于脊骨并置。子系气囊和母系气囊同时膨胀。
如果需要，母系脉管可由任何市场上可买到的支架所支持。线上的气囊可用作对子系导管的替代。
在一替代实施例中，导管系统可设置成：位于母系气囊近侧的子系气囊部分向前超出导线直至分叉处。在母系导管位于母系导线上的情形中，由于子系导线和母系导管上的母系支架之间的张力而发生母系支架与子系脉管的小孔的对准，该张力防止母系导管进一步前进。在母系导管位于子系导线上的替代情形中，由于母系导线和母系导管上的母系支架之间的张力而发生母系支架与母系脉管的小孔的对准，该张力防止母系导管进一步前进。在两种情形中，子系支架朝远侧前进，与母系支架对准并扩大。
在较佳实施例中，图1和4示出母系导管是线上（OTW）设计，而子系导管是快速交换（RX）设计，且子系导管在母系导管远侧约3厘米。子系气囊刚好放置在母系导管梢端的远侧，此种设置使导管系统的整个型面最小并能最大限度追踪动脉。该系统可附加地具有压接在气囊上的支架。子系支架可以大约是子系气囊或母系支架长度的一半。可仅仅轻微地压接母系支架的近端，以使能独立操作子系导管的气囊部分，即可在不移动母系支架的条件下推动或拉动该子系导管的气囊部分。该方法包括下列步骤：
1.使导管系统前进至分叉处，而子系气囊导管部分和母系气囊导管部分位于它们的相应脉管中。
2.由于母系支架和子系导管之间的张力，因而母系导管不再能够前进。
3.将子系气囊的近侧部分回拉到母系支架中并与不透性标记物对准。
4.在紧紧地保持母系导管和子系导管的同时，操作者轻轻向前推动。
5.使子系气囊膨胀并使子系支架扩大，大约子系气囊的远侧部分的一半会使“半支架”扩大，而子系气囊的近侧部分的一半会在母系脉管内部扩大，并且使母系支架的近侧部分部分地扩大。
6.一旦子系支架完全展开，则母系气囊可完全扩大，以使母系支架的远侧部分展开。
7.可使用传统的接触治疗以确保完全并置。在一特定方面，可在没有支架的条件下使用子系气囊导管部分。这可有利于母系支架围绕子系脉管的小孔对准。子系气囊会如同上文步骤三中所概述的那样用于对准，并且使母系支架的近侧部分扩大。
在一替代实施例中，图5示出母系导管是线上（OTW）设计，而子系导管是快速交换（RX）设计，且子系导管的气囊部分在母系导管的气囊部分朝远侧约3厘米。该系统可附加地具有压接在气囊上的支架。子系支架可以大约是母系气囊或支架长度的一半。可仅仅轻微地压接母系支架的近端，以使能独立操作子系导管的气囊部分，即可在不移动母系支架的条件下推动或拉动该子系导管的气囊部分。该方法包括下列步骤：
1.使OTW成环，使得一个操作者能利用一个手来保持两根导线，然后利用另一个手来推动两个导管。
2.使导管系统前进至分叉处，而如上述实施例中步骤2到3中所披露，子系气囊导管部分和母系气囊导管部分对准在它们的相应脉管中。
3.在紧紧地保持母系导管和子系导管的同时，向前推动导管系统，直到母系气囊导管部分停在脊骨处为止。
4.使子系气囊膨胀并使子系支架扩大，大约子系气囊的远侧部分的一半会使“半支架”扩大，而子系气囊的近侧部分的一半会在母系脉管内部扩大，并且使母系支架的近侧部分部分地扩大。
5.一旦子系支架完全展开，则母系气囊可完全扩大，以使母系支架的远侧部分展开。
6.可使用传统的接触治疗以确保完全并置。在一特定方面，可在没有支架的条件下使用子系气囊导管部分。这可有利于母系支架围绕子系脉管的小孔对准。子系气囊会如同上文步骤三中所概述的那样用于对准，并且使母系支架的近侧部分扩大。
在一替代实施例中，母系导管是线上设计，而子系导管是快速交换设计，且子系导管朝远侧约3厘米。该系统可附加地具有压接在气囊上的支架。子系支架可以大约是母系气囊或支架长度的一半。可仅仅轻微地压接母系支架的近端，以使能独立操作子系导管气囊部分，即可在不移动母系支架的条件下推动或拉动该子系导管气囊部分。该方法包括下列步骤：
1.仅仅放置子系导线，然后使该系统滑到引导导管中。就在离开引导导管之前，母系导线通过导管插入并进入母系脉管中，然后将该系统从引导导管中推出。从而减小线缠绕。
2.使导管系统前进至分叉处，而子系气囊导管部分和母系气囊导管部分对准在它们的相应脉管中。
3.使导管系统前进至分叉处，而如上述实施例中步骤2中所披露，子系气囊导管部分和母系气囊导管部分对准在它们的相应脉管中。
4.使子系气囊膨胀并使子系支架扩大，大约子系气囊的远侧部分的一半会使“半支架”扩大，而子系气囊的近侧部分的一半会在母系脉管内部扩大，并且使母系支架的近侧部分部分地扩大。
5.一旦子系支架完全展开，则母系气囊可完全扩大，以使母系支架的远侧部分展开。
6.可使用传统的接触治疗以确保完全并置。在一特定方面，可在没有支架的条件下使用子系气囊导管部分。这可有利于母系支架围绕子系脉管的小孔对准。子系气囊会如同上文步骤三中所概述的那样用于对准，并且使母系支架的近侧部分扩大。
在一替代实施例中，系统的母系气囊和系统的子系气囊是对准的。该实施例可包括母系支架和子系支架或任一支架。当存在母系支架和子系支架时，子系支架将大约是母系支架长度的一半，使得子系支架能安装在子系气囊的远侧半部上。此外，子系导管的近侧部分将压接在母系支架之下。与覆盖子系气囊整个长度的全长支架相比，此种双重支架设置会减小型面。
在此所描述的方法可替代地包括对导管和引导线端口进行冲洗以助于操纵性的步骤。在此所描述的方法可替代地包括采用成对搭锁联接器将导管锁定在一起的步骤。
在另一特定方面，每个气囊导管部分可包括至少一个不透性标记物。采用此种构造，通常可使用荧光检查法来观察到标记物的分离，以指示气囊导管部分已通至小孔之外且子系气囊导管部分已通到子系脉管中，由此使支架的通道与子系脉管对准。
在另一特定方面，考虑使导管系统设计对快速交换设计和线上设计的组合进行覆盖；为了可视目的，混合型式是较佳的，这是由于在使用荧光检查法时混合型式较易于辨别。
在另一特定方面，近侧气囊可有差别地扩大，使得气囊的一端可在另一端之前扩大。
在另一特定方面，近侧气囊导管部分可接纳能在变压下压接的支架，以使远侧气囊导管部分能自由运动。
在另一特定方面，支架可压接在近侧气囊导管部分上，且该支架可设计成以可变型面展开，以较佳地适应患者结构。
在另一特定方面，可通过拉离来输送远侧气囊导管部分。
所有上述实施例都可使用直径范围是从2.5到5.0毫米的母系支架及直径范围是从2.0到5.0毫米的子系支架。支架的长度可以在4到40毫米的范围内。支架在导管上的位置并不固定，并且支架可定位在任一导管上或两个导管上。
图1示出具有远侧子系气囊导管部分30的导管系统10，该远侧子系气囊导管部分包括压接有子系支架33（未示出）的气囊32。子系支架33会比母系支架23短。在一特定的实施例中，子系支架33是母系支架23（未示出）长度的一半。在本领域已知的标准条件下，压接该远侧子系支架33。近侧母系气囊导管部分20包括母系气囊22和母系支架23。如图36-37所示，沿纵向方向和周向方向有差别地压接母系支架23。在特定的实施例中，在通常的条件下对母系支架23的远侧半部23a进行压接，以确保母系支架23在与远侧子系气囊32对准的过程中不会移动。此外，在非标准的、相对放松的条件下对母系支架23的近侧部分23b进行压接，从而即使子系气囊导管部分30的一部分被周向封闭，远侧子系气囊导管部分30仍可自由运动。母系导管21和子系导管31通过中空交换端口40可滑动地彼此附连。交换端口40在线导管上方嵌在母系导管的侧部中。交换端口40是10厘米长，且具有的直径足够大，以允许插入快速交换的子系导管31和子系气囊32。该交换端口40在长度上可从1厘米改变到30厘米。子系导管32进入交换端口40的进口位于近侧，而子系导管32的出口位于交换端口40的远端。子系导管32装载通过交换端口40，且子系气囊32从交换端口40的出口向远侧延伸5厘米。然而，可使交换端口40邻近母系气囊221到30厘米。母系支架23可在已装载通过交换端口40之后压接到气囊上。交换端口40须具有紧密配合以减小导管型面，并具有低摩擦以使操作者能使导管易于相对彼此滑动。
图2示出一实施例的横断剖视图，该实施例使用图1所示的相同交换端口40使母系导管的气囊部分20邻近子系导管气囊部分30。子系气囊32朝远侧离交换端口40的出口5厘米。如上所述，子系气囊32可朝远侧离交换端口401到30厘米。
图3示出一实施例的横断剖视图，其中母系导管和子系导管都具有快速交换设计。在此种特定实施例中，其中一个导管具有嵌在其侧部中的交换端口40，而另一个导管装载通过该交换端口40。通常，须在将支架压接在气囊部分上之前装载导管。
图4示出一实施例的横断剖视图，其中母系导管和子系导管都具有线上设计。在此种特定实施例中，其中一个导管具有嵌在其侧部中的交换端口40，而另一个导管并不具有交换端口。不具有交换端口的导管须装载在具有交换端口40的导管上。通常，须在将支架压接在气囊部分上之前装载导管。
图5-8示出将导管连接在一起的端对端捕获管41。如图5-6示出，捕获管41是薄的聚合物中空杆，该中空杆从朝远侧离开内镜附连处4310厘米的一点到朝近侧离开快速交换导管的快速交换端口4710厘米的远侧点覆盖母系导管和子系导管。图7示出双重的快速交换母系导管和子系导管，使得捕获管41的端点能朝近侧离开快速交换导管的位于近侧导管上的快速交换端口4710厘米。图8示出具有双重线上设计的导管系统，因此捕获管41端点终止于朝近侧离开最远侧导管的气囊部分30厘米处。捕获管41防止导管缠结。捕获管41在整个临床治疗过程中保持就位。图6示出具有线上设计的远侧子系导管31和具有快速交换设计的近侧母系导管21。图5示出具有线上设计的近侧母系导管21和具有快速交换设计的远侧子系导管31。
图9-12示出装配在如上所述的双重导管上的可拆除捕获管42，而该捕获管42具有聚合物附件44。一旦操作者将导管系统放置在分叉附近时，操作者可抓持该聚合物附件44并从这些导管中拉出捕获管42。图10示出具有线上设计的远侧子系导管31和具有快速交换设计的近侧母系导管21。图9示出具有线上设计的近侧母系导管21和具有快速交换设计的远侧子系导管31。图11示出具有可拆除捕获管42的双重快速交换设计。图12示出具有可拆除捕获管42的双重线上设计。
图13-16示出使一个导管能卡配到另一个导管中的拉链45。拉链45基本上是沟槽，该沟槽形成凹陷的接纳剖面，并沿直线刻到导管的外表面中。该沟槽可以是导管特定部分上的单个沟槽或者其可端对端行进。或者，导管可具有一系列长度是1到10厘米的短沟槽，这些沟槽沿导管长度或仅仅特定部分行进。全长的端对端拉链会具有减小的型面和减小的与脉管之间的摩擦。所产生的沟槽可接纳另一导管，并防止导管在操作者使导管行进至分叉处的过程中移动。一旦在该位置处，操作者仍可使这些导管相对彼此前后滑动。使用沟槽的母系导管可具有在上述若干实施例中所描述的全压接支架；然而，可允许操作者选择任何市场上可买到的具有或不具有支架的导管，并通过拉链45来安装该市场上可买到的导管。具有空拉链45的母系导管会使母系支架23完全压接在母系导管21的远侧气囊部分22a上。在对市场上可买到的导管进行装载之后，操作者须在开始临床治疗之前将母系支架的近侧部分22b压接就位。该选择对于操作者来说极其重要，这些操作者可减小总的导管存量，但却具有更多的选择来治疗分叉损伤。图14示出具有线上设计的远侧子系导管31、具有快速交换设计和短拉链45的近侧母系导管21。图13示出具有线上设计的近侧母系导管21和具有短拉链45的远侧子系导管31。图15示出具有短拉链45的双重快速交换设计。图16示出具有短拉链45的双重线上设计。图18示出具有线上设计的远侧子系导管31、具有快速交换设计和端对端拉链45的近侧母系导管21。图17示出具有线上设计的近侧母系导管21和具有端对端拉链45的远侧子系导管31。图19示出具有端对端拉链45的双重快速交换设计。图20示出具有端对端拉链45的双重线上设计。
图21-24示出可用于一替代实施例的市场上可买到的导管，其中为操作者提供母系导管21，而母系支架23（未示出）压接在母系导管的气囊的远侧部分22a上。母系支架23的近侧部分23b是非压接的。操作者可将任何市场上可买到的导管或气囊安装在如下的线上：该线通过母系支架近侧部分23b的端部并从母系支架23的侧孔25离开。参见图36，操作者可使这些导管对准，以适应患者结构并对母系支架23的近侧部分23b进行压接。操作者可紧紧地压接支架23，使得这些支架不会相对彼此运动。操作者可将导管放置在分叉处，且如果需要的话，把市场上可买到的导管向后拉以按需要调整对准。然后，操作者可向远侧轻轻地推动系统，以确保完全并置。图21示出具有快速交换设计的远侧子系导管31和具有线上设计的近侧母系导管21。图22示出具有线上设计的远侧子系导管31和具有快速交换设计的近侧母系导管21。图23示出双重快速交换设计。图24示出双重线上设计。
然而，市场上可买到的导管的用于治疗单个脉管的一次性装置的替代实施例在各种组合中可与聚合物套筒匹配在一起。操作者为患者结构选择两个导管，然后使一定尺寸的聚合物套筒从远端在两个导管上滑动。一旦操作者已使导管对准，可利用热源或光源对聚合物套筒进行处理，以使两个导管在摩擦作用下收缩并粘结在一起。聚合物套筒由在利用热源或光源进行处理时、可用作收缩包套的通常聚合物所制成。聚合物套筒的聚合物例如可由聚烯烃所制成，聚烯烃即用在制造收缩包套中的化学制剂。聚合物套筒不会交联地或共价地附连于这些导管，若干类型的聚合物在市场上可买到并具有必需的性能，即薄、强、不粘以及10分钟或10分钟以下的反应至源头的反应时间。聚合物套筒通常在长度上是15厘米，并具有各种直径以适应4弗纶奇到20弗纶奇的通常导管直径。操作者可在治疗之前测试通过施加轻微压力来保持粘结。如果聚合物套筒并非紧紧保持，则操作者可选择使用较小直径的聚合物套筒或者通过将彼此邻近地放置聚合物套筒来使用一个以上聚合物套筒。或者，若干长度上是从1厘米到10厘米的较小套筒可放置在导管的若干不同部分上。
图25-30以八个步骤示出一较佳实施例的输送顺序。步骤1示出将0.035英寸的导线50一直引至分叉处。步骤2示出引导导管53在导线50上的轨迹。步骤3示出将导线50移除和引导导管53的放置位置。步骤4示出子系脉管2中的快速交换相容线52和母系脉管1中的线上相容线51的轨迹及放置。步骤5A和5B示出在远侧都位于导线上方的导管系统10的轨迹。步骤6A示出子系气囊32的膨胀、子系支架33的放置以及母系支架23的部分展开。步骤6B示出母系气囊22膨胀以将母系支架23的远侧部分23a放置在母系脉管1中。步骤7A示出主支脉中的母系支架23，使侧孔25面向子系脉管2。步骤7B示出分叉的支架部分地位于子系脉管2中以及母系脉管1，且在该母系脉管处，母系支架23的侧孔25朝主分叉脉管1打开。
在一替代实施例中，输送导管的母系气囊具有锥形端部，以适应具有非均匀型面的气囊和支架。例如，子系支架的近端可设计成比远端具有较大的圆周，以补偿自然分叉的结构。子系气囊希望合理地具有锥度，以使支架适当地膨胀并确保完全并置。此外，可将母系支架设计成沿其型面有差别地膨胀，以补偿脊骨或小孔处的较大动脉直径。换言之，母系气囊和母系支架的近端和远端会具有较小的圆周，而母系支架的中心部分会具有加大的圆周。
在一替代实施例中，母系气囊具有锥形端部，以适应远侧气囊导管部分和导线内腔。此外，母系气囊设计成用于有差别的膨胀，以适应自然脉管结构。
在一较佳实施例中，远侧（子系）气囊导管部分在快速交换类型设计的导管上压接有半支架。子系支架是4-20毫米，而子系气囊大约在长度上是其两倍。有差别地压接10-30毫米的母系支架，以允许对子系气囊导管部分进行独立操作。对母系支架的远侧部分进行充分的紧密压接，以防止整个支架在治疗过程中无意移动。对母系支架的近侧部分进行紧密压接，以刚好足以减小横截面并使子系气囊导管部分能相对于母系气囊导管部分朝远侧或朝近侧运动。近侧（母系）气囊导管部分是线上设计，而母系气囊朝近侧离子系气囊约3厘米。
在一替代实施例中，支架设计成使支架的中间部分能相对于近端和远端有差别地膨胀。具体地说，该设计便于将支架放置成横贯母系脉管中的分叉受损，而这是由于该支架比起具有恒定型面的支架、相对于端部在中间部分中具有较大圆周。此外，可对型面进行调整，使得最大圆周能放置在支架中点近侧或远侧。在特定实施例中，最大圆周在支架中点远侧，然而对于各种患者结构来说可易于逆转。
部分压接具有以下关键特征：在输送和放置过程中可保持充分的支架保持性，并且仍允许次级系统具有可调整性和可输送性。图31是放置在气囊导管上之前的部分压接分叉支架。图32-34以三个步骤示出本发明的实施例。首先，分叉支架23部分地压接在该分叉支架到母系导管21的远侧部分23a大约三分之一上，且子系导管31装载通过母系导管21和母系支架23，在此可单独地压接子系支架33。其次，对子系支架33进行压接并朝近侧拉回该子系支架，以使子系支架33的近端对准在母系支架23的远端附近。第三，可对母系支架的近侧部分23b进行压接以减小外直径，然而仍允许这两个导管相对彼此独立运动。
图35示出不具有子系支架的子系气囊导管31的剖视图。子系导管31位于母系导管21顶部。母系支架23绕母系气囊22和子系导管31有差别地进行压接，这是由于子系导管31的型面小于母系导管21的型面。差别压接是非均匀的并且可产生各种横截面形状，以适应不同的导管设计、气囊设计以及支架设计。例如，梨形或8字形是可能的构造。目前的实施例设计成尽可能减小型面。在一较佳制造方法中，将保护外壳46放置在这两个导管之间。保护外壳46仅仅需要对在压接过程中将接触的部分进行覆盖，然后可拆除该保护外壳46。图36示出安装在母系气囊22上的母系支架23和通过母系支架22安装在母系导管21上的子系导管31的侧视图。将在标准条件下对母系支架23的远侧部分23a进行压接，以将支架紧紧地保持于母系气囊22和母系导管21。对母系支架23的近侧部分23b进行部分地压接以减小型面，然而仍允许子系导管31相对于母系导管21朝近侧或远侧自由运动。该实施例示出，支架23沿周向和纵向方向有差别地压接。压接量将由支架设计和尺寸、导管尺寸以及气囊尺寸所确定；因此压接沿纵向轴线有差别。图37示出安装在母系气囊22上的母系支架23和通过母系支架23安装在母系导管21上的子系导管31的侧视图。子系导管31也包括可在标准条件下进行压接的支架33。将在标准条件下对母系支架23的远侧部分23a进行压接，以将支架紧紧地保持于母系气囊22和母系导管21。在一实验中，对该设置进行测试以通过朝近侧拉动子系导管31和子系支架33来确定母系支架23远侧压接的强度。结果是子系导管31成功地通过被压接的母系支架23，并且仍同样保持子系支架33。
在压接过程中可使用附加特征，例如对气囊附加轻微的正内压，使得最终的气囊表面枕出支架外直径约0.002英寸。该过程可产生如下设计：防止支架与脉管配合，由此减小摩擦并同时改进支架保持性。此外，该过程改进安全性并减小对脉管的创伤。
虽然，上述实施例披露压接在其远侧半部处或围绕其远侧半部压接的分叉支架；然而这并非局限于此。该支架会取决于支架设计而沿其轴线有差别地压接；例如如果支架侧部中的孔并非沿轴线居中的话。较佳的是，可使分叉支架的远侧压接部分仅仅朝远侧伸出子系导管所通过的孔。或者，远侧压接部分可部分或完全延伸超出子系导管所通过的孔。
尽管已结合特定实施例和示例描述了本发明，但显然在阅读了本发明的条件下，许多替代方式、修改和变型对熟悉本领域的人员来说都是显而易见的。因此，本发明想要包含所有这样的落入所附权利要求书的精神和广泛范围内的替换、修改和改型。
Claims (14)
1.一种用于治疗具有母系脉管和子系脉管的分叉脉管的输送系统，所述输送系统包括：
母系导管，所述母系导管具有远端，且所述母系导管具有母系脉管导线内腔和设置在所述远端附近的母系气囊；以及
子系导管，所述子系导管具有远端，且所述子系导管在所述远端附近的子系气囊导管部分上具有子系气囊，所述子系气囊导管部分具有子系脉管导线内腔；以及
母系支架23，所述母系支架设置在所述母系气囊22上，其中所述母系支架包括近侧开口、远侧开口以及侧孔，所述侧孔位于所述近侧开口和所述远侧开口之间并用于与所述子系脉管的小孔对准，其中所述支架具有压接构造和扩大构造，所述压接构造用于通过脉管输送至所述分叉脉管，而在所述扩大构造中，所述支架对所述母系脉管或所述子系脉管的壁进行支承，以及
其中，在所述母系支架处于所述压接构造的情形下，所述子系导管延伸通过所述母系支架的近侧开口并且从侧孔离开，而当所述母系支架处于所述压接构造时，所述子系导管能够相对于所述母系导管滑动，使得当所述母系支架处于所述压接构造时，所述子系气囊的近侧部分能够在所述母系支架的近侧部分下方缩回，从而所述子系气囊的膨胀使所述支架的近侧部分扩大，并使所述侧孔与所述子系脉管的小孔对准。
2.如权利要求1所述的输送系统，其特征在于，在所述母系支架处于所述压接构造的情形下，所述母系气囊和所述子系气囊能够独立膨胀并且能够彼此定位。
3.如权利要求1所述的输送系统，其特征在于，在所述母系支架处于所述压接构造的情形下，所述子系导管的具有所述子系气囊的部分在输送过程中设置在所述母系气囊的远侧，使得在输送过程中所述输送系统的总型面最小。
4.如权利要求1所述的输送系统，其特征在于，当所述母系支架处于所述压接构造时，所述子系导管能够相对于所述母系导管朝近侧缩回，使得所述子系气囊部分地位于所述母系支架内。
5.如权利要求4所述的输送系统，其特征在于，所述母系导管和所述子系导管中的每个导管包括至少一个不可透性标记，从而能够使用荧光检查法来观察所述标记的分离，当所述子系气囊朝近侧缩回到所述母系支架中时，使所述母系导管能相对于所述子系导管对准。
6.如权利要求1所述的输送系统，其特征在于，所述输送系统还包括设置在所述子系气囊上的子系支架，所述子系支架具有压接构造和扩大构造，所述压接构造用于输送通过脉管，而在所述扩大构造中，所述支架对脉管壁进行支承。
7.如权利要求6所述的输送系统，其特征在于，所述子系支架包括近端和远端，所述近端具有比所述远端更大的圆周以补偿所述分叉脉管的结构。
8.如权利要求6所述的输送系统，其特征在于，所述子系气囊能够收缩到所述母系支架中，从而所述子系气囊的膨胀同时使所述母系支架和子系支架的近侧部分扩大，而所述母系支架的远侧部分保持于所述压接构造。
9.如权利要求6所述的输送系统，其特征在于，所述子系支架的长度大约是所述母系支架长度的一半，且所述子系支架安装在所述子系气囊的远侧半部上。
10.如权利要求4所述的输送系统，其特征在于，所述母系支架包括在所述侧孔远侧的远侧部分和在所述侧孔近侧的近侧部分，在所述压接构造中，在标准条件下对所述母系支架的远侧部分进行压接，以在所述输送系统的行进过程中将所述母系支架紧紧地保持于所述母系气囊和所述母系导管，而对所述母系支架的近侧部分进行部分地压接，以减小型面，然而仍允许所述子系导管相对于所述母系导管朝近侧或远侧自由运动。
11.如权利要求4所述的输送系统，其特征在于，所述母系支架的近侧部分压接于所述母系导管和所述子系导管，同时所述子系导管在处于压接结构时能够相对于所述母系导管滑动。
12.如权利要求1所述的输送系统，其特征在于，所述母系导管和所述子系导管可滑动地附连于彼此，而捕获管防止所述导管缠结。
13.如权利要求1所述的输送系统，其特征在于，每个所述导线内腔具有近侧开口和远侧开口，且所述母系导管和所述子系导管中的一个导管是线上类型的导管，而另一个导管是快速交换类型的导管。
14.如权利要求1所述的输送系统，其特征在于，所述母系导管和所述子系导管都是线上类型的导管，或者所述母系导管和所述子系导管都是快速交换类型的导管。
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| US19434608P | 2008-09-25 | 2008-09-25 | |
| US61/194,346 | 2008-09-25 | ||
| PCT/US2009/058505 WO2010036982A1 (en) | 2008-09-25 | 2009-09-25 | Partially crimped stent |
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| CN102215780A CN102215780A (zh) | 2011-10-12 |
| CN102215780B true CN102215780B (zh) | 2015-10-14 |
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| CN200980143592.XA Active CN102215780B (zh) | 2008-09-25 | 2009-09-25 | 部分压接支架 |
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| EP (2) | EP2344068B1 (zh) |
| JP (1) | JP5635515B2 (zh) |
| CN (1) | CN102215780B (zh) |
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| US6706062B2 (en) * | 1998-01-14 | 2004-03-16 | Advanced Stent Technologies, Inc. | Extendible stent apparatus |
| CN1867374A (zh) * | 2003-10-16 | 2006-11-22 | Minvasys公司 | 用于支撑分叉血管的导管系统 |
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| CA2739007C (en) | 2017-10-31 |
| EP2344068A4 (en) | 2015-09-23 |
| JP2012503534A (ja) | 2012-02-09 |
| US20240082029A1 (en) | 2024-03-14 |
| US11000392B2 (en) | 2021-05-11 |
| US9737424B2 (en) | 2017-08-22 |
| EP2344068B1 (en) | 2022-10-19 |
| CA2739007A1 (en) | 2010-04-01 |
| US20210220156A1 (en) | 2021-07-22 |
| AU2009296415A1 (en) | 2010-04-01 |
| US20150073521A1 (en) | 2015-03-12 |
| US11839562B2 (en) | 2023-12-12 |
| CN102215780A (zh) | 2011-10-12 |
| AU2009296415B2 (en) | 2015-11-19 |
| JP5635515B2 (ja) | 2014-12-03 |
| EP4147681A1 (en) | 2023-03-15 |
| EP2344068A1 (en) | 2011-07-20 |
| WO2010036982A1 (en) | 2010-04-01 |
| US20170319366A1 (en) | 2017-11-09 |
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