CN107847243A - 用于植入物输送的系统和方法 - Google Patents

用于植入物输送的系统和方法 Download PDF

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CN107847243A
CN107847243A CN201680046546.8A CN201680046546A CN107847243A CN 107847243 A CN107847243 A CN 107847243A CN 201680046546 A CN201680046546 A CN 201680046546A CN 107847243 A CN107847243 A CN 107847243A
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implant
torquer
passage
sheath
cutting element
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Terumo Corp
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Abstract

描述了一种植入物输送系统。植入物输送系统使用植入物、植入线、输送护套和扭矩装置。扭矩装置可以包括切割输送护套的切割元件和用于固定植入物输送线的位置的夹紧装置。

Description

用于植入物输送的系统和方法
相关申请
本申请要求于2015年8月11日提交的名称为“System and Method of ImplantDelivery”的美国临时申请号62/203,882的优先权，其全部内容通过引用合并于此。
背景技术
由于许多原因，可能需要将植入物输送到脉管系统的各个区域。例如，栓塞线圈可以输送到脉管系统的目标区域以封闭空间，支架可以输送到目标区域以将流体转移离开某个区域或撑开血管，栓塞保护装置(“EPD”)或血液过滤器可以输送到目标区域的下游以捕获在用支架或球囊撑开血管的操作期间脱出的血栓，可以将凝块回收器输送到目标区域以捕获和去除血栓。
由于许多血管的尺寸小、血流造成的高浊度、弯曲的解剖以及其他原因，植入物输送可能是困难的。输送植入物的典型方法涉及将植入物从导管/输送装置推出或通过取出导管/输送装置以暴露植入物。一般而言，植入物被有策略地放置，使得在部署时植入物将位于目标部位处或附近。由于脉管系统中遇到的困难情况，当将植入物从输送装置推出或取出输送装置时，植入物可能显著移位。
因此期望一种能够快速且准确地将植入物放置在治疗部位的植入物输送系统和方法。
发明内容
描述了一种植入物输送系统。
在一个实施例中，植入物输送系统包括植入物、承载植入物的植入线、护套和扭矩装置。扭矩装置包括切割元件并容纳护套的一部分和用于固定植入线的位置的夹紧装置。护套可通过扭矩装置取出以切割护套并将其与植入线分离。
在一个实施例中，分离器管位于扭矩装置内的切割元件附近。在切割操作期间，分离器管引导护套穿过单独的护套内腔。
在一个实施例中，切割元件沿扭矩装置中的护套内腔定位。
在一个实施例中，扭矩装置包括夹紧元件。夹紧元件可以用来选择性地将夹头压到植入线上。
在一个实施例中，植入物输送系统用于输送栓塞保护装置或过滤器。
附图说明
通过以下本发明实施例的说明并参考附图将阐明和使得本发明的实施例的这些和其他方面、特征和优点能够是显而易见的，其中：
图1示出了根据本发明的导丝的远端、导引导管、输送护套、植入物输送线和植入物的实施例。
图2-4示出了根据本发明的植入物输送系统中使用的扭矩装置的实施例。
图5示出了根据本发明的用于植入物输送系统中的扭矩装置的切割元件的实施例。
图6示出了在根据本发明的植入物输送系统中使用的扭矩装置的替代实施例。
具体实施方式
现在将参照附图描述本发明的具体实施例。本发明可以以许多不同的形式来实施，然而，不应解释为限于在此阐述的实施例；相反，提供这些实施例使得本公开将是彻底和完整的，并且将本发明的范围充分地传达给本领域技术人员。在附图中示出的实施例的详细描述中所使用的术语不旨在限制本发明。在附图中，相同的数字表示相同的元件。
通常通过较小的导管或输送装置输送植入物或诸如EPD、过滤器、线圈、塞子、封堵器、支架、凝块回收器或其它植入物的血管装置，因为医疗过程通常在较小的血管中发生，例如在头上的那些血管。尽管尺寸很小，但输送系统必须具有较高的推力才能使装置进入治疗部位，并且必须能够导航可能弯曲的脉管系统。
传统的输送方法通常涉及使用导引导管3以靠近血管1的治疗区域，如图1所示。导丝2首先穿过患者的血管1前进，直到其远端位于治疗区域处或其附近。接下来，导引导管3在导丝2上前进，直到其远端也位于血管1的治疗区域处或附近。然后通过导引导管3将植入物5在输送护套30、导管或其他输送装置中输送，直到护套30的远端位于治疗部位。最后，可以通过推进附接的输送线28将植入物5推出护套30，或者可以取出护套30以暴露植入物5。
由于与血流相关的浑浊，由于血管尺寸较小(以及其他因素)造成的在治疗部位潜在的可用空间有限以及植入物5随着护套30取出而移动的趋势，使得输送过程困难。如果在输送期间植入物5显著移位，则外科医生必须再次将植入物5导航到治疗部位，这可能需要在侵入性手术期间的宝贵时间。
就此而言，本发明的实施例涉及一种输送系统，其允许医师既锁定植入物5及其输送线28相对于患者体内的目标部位的位置，同时还经由近端切割装置取出并移除外部输送护套30(部分或全部移除)。因此，外部输送护套30可以在手术过程中快速撤出并与输送线28分离，而不需要从输送系统的近端部分解锁输送线28。
以下实施例利用护套切割系统来切割护套30，同时护套取出以暴露和部署植入物5。在一个实施例中，植入物输送系统用于输送具有附接植入线的栓塞保护装置(EPD)。栓塞保护装置是一种血管过滤器。它们经常放置在治疗部位的远端。在一个示例中，使用支架或球囊来扩张钙化区域以使血液能够在形成血栓的区域中流动。在输送支架或球囊之前，将EPD或过滤器放置在该目标区域的下游，使得由支架或球囊脱出的任何血栓被EPD或过滤器捕获，从而血栓不会在远端位置聚集和导致以后的问题。EPD或过滤器可以在之后取出。尽管使用术语“植入线”或“输送线”，但是这些术语可以包括线、海波管、杆或其它机构，并且还广义地意指与植入物连接的元件或在其上安装植入物的元件。
图2-4示出了位于植入物输送系统的近端部分处的扭矩装置10的各个方面。由于植入物输送系统利用导引导管3将植入物导航至脉管系统1内的适当治疗部位，所以在治疗期间扭矩装置10优选地位于导引导管3的近端。关于这些图，左端是远端的，而右端是相对于手术进入患者的近端。因此，扭矩装置10的左端位于导引导管3的近端邻近或附近，植入物5连接到植入线28的远端(参见图1)，并且如果植入物已经被输送，则植入物位于导引导管3中或者位于血管1中。
如前所述，扭矩装置10包括用于将护套30与输送线28分开和分离的切割机构，以及用于锁定相对于扭矩装置10的输送线28的位置的锁定机构。首先介绍切割机构，其目的是在护套30取出以暴露在治疗部位处的植入物5时切割护套30(参见图1和4)。扭矩装置10包括切割元件12，切割元件12优选地配置成仅切割护套的一个面或一条边，从而造成沿护套30的长度纵向延伸的狭缝。在一个示例中，切割元件12是由金属或硬化聚合物构成的尖锐刀片。
扭矩装置10的本体构件11的远端部分包括公共通道32，护套30和植入线28穿过该公共通道。公共通道32分离成护套内腔16以及在更近端的位置的植入线内腔34(最佳可见于图2中)。然而，公共通道和植入线内腔34彼此对齐，而也可以认为是一个单一的细长通道。切割元件12位于该分支位置附近，使得尖锐边缘12a朝向远端方向并突出到公共通道32中，而刚好足以切穿护套30的底部。切割元件12包括分离器通道14，分离器通道14大致对齐并位于植入线内腔34内以允许植入线28通过。护套内腔16远离切割元件12和植入线内腔34而倾斜(例如，在与切割元件12相反方向上或远离切割元件12)，以便使得带狭缝的护套30导向成与植入线28歪斜的方向或导向成远离植入线28的方向。植入线28通过其切割狭缝离开护套30，从而能够保持其在扭矩装置10中的位置。
在一个实施例中，护套30可以包括弱化区域或预制狭缝，该预制狭缝与切割元件12的尖锐边缘12a对齐，以便于切割过程。例如，该弱化区域或预制狭缝可以位于护套30的近端或边缘处。在另一个实施例中，护套30不具有弱化区域或预制狭缝，并且尖锐边缘12足以切割护套。
扭矩装置10的近端包括夹紧机构，该夹紧机构选择性地将植入线28夹持在适当位置。更具体地，夹头20位于扭矩装置10的近端处，具有穿过其的通道，该通道与植入线内腔34对齐。装置10的主体11包括位于主体11的近端上的螺纹部分11a，在夹头20的周围和/或附近。配合螺纹位于旋拧元件18的内部，从而允许旋拧元件18拧在夹头20上的本体上。旋拧元件18的侧部上的近端通道18b允许植入线28根据需要穿过。
当旋拧元件18向远端拧到主体11的螺纹11a上时，其内表面18a压靠夹头20的成角度的外表面，导致夹头20压缩或减小其内部通道的尺寸。如果植入线28通过夹头20定位，那么夹头20将压缩或夹住植入线28，固定其相对于扭矩装置10的纵向和旋转位置。沿相反方向旋转旋拧元件18以使其相对于主体11向近端移动，导致旋拧元件18的内表面18a移离夹头20，释放植入线28上的压缩或夹紧，并且允许导线28相对于主体11移动。由于植入线28可以是固定的，所以植入物5类似地被固定，因为其远端连接到植入线28。因此，医师可以锁定夹头20以锁定患者体内的植入物5的位置，并取出护套30以暴露植入物5，使得植入物5将相对固定地在装置的远端处。虽然由于血液流动引起的高浑浊度可能引起植入物的一些小的移动，但锁定夹头20通常会减少否则可能发生的任何实质性移动。
夹头20可以从许多不同的设计中选择。例如，夹头20可以由弹簧钢构成，沿着其长度方向具有一个或多个切口，以允许其随着旋拧元件18移离或者抵靠它而使其膨胀和收缩。夹头20的另一个示例性实施例，其具有多个锥形金属块，这些金属块通过柔性结合介质(例如，合成橡胶或天然橡胶)而保持为圆形的位置(类似于星形的点，或者实际上是夹爪卡盘的夹爪)。
传统输送系统的一个缺点是，由于推出植入物或取出护套时护套和植入物之间的机械相互作用，植入物可以在输送时四处移动。由于本实施例中的用户可以通过夹紧机构(旋拧元件和夹头)将植入物锁定在适当的位置，因为植入物更好地保持其位置，所以植入物输送更平稳地进行。
如前所述，扭矩装置10包括分离器管14，以确保护套和植入线彼此分离，而分别进入通道16和34中。在一个示例中，分离器管14是聚合物管，并且正好位于公共通道32的一部分中的切割元件12上方并且延伸到植入线通道34中(参见图3-5)。在其他示例中，分离器管14也可以是金属的。最佳可见于图5中，当植入线28穿过分离器管14的内部并进入植入线内腔34时，护套30在分离器管的近端周围向近端牵拉。切割元件12的尖锐边缘12a延伸或邻近分离器管14的底部，从而允许切割元件12在护套30经过切割元件12时切割护套30的底部30a。
在一个实施例中，主体构件11完全地形成扭矩装置10的通道16、32和34。在另一个实施例中，如图2和4所示，几个分立部件构成扭矩装置10。图2中的通道16、32和34在图3的分解图中更好地示出，其中配合件22连接到主体构件11并与主体构件11配合以限定通路与扭矩装置10成一体。
具体地，通道16、32和34由配合件22上的凹陷部分16a、32a和34a以及主体构件11上的凹陷部分16b、32b和34b组成。一旦连接，凹陷部分彼此对齐以形成上述通道16、32和34。优选地，在主体构件11和配合件22两者上的凹入部分具有相等的深度，使得每个凹入部分构成通道12、32和34的大约一半的结构。或者，凹陷部分可以构成通道的不相等部分，或者仅一个部件(例如，主体构件11)可以具有凹陷部分，而另一个部件(例如，配合件)可以具有平坦的非凹陷部分，这些部分压靠并完成通道16、32和34(即，这些通道的直径可能不完全是圆形的)。
如在图3中最清楚地看到的，配合件22和主体构件11分别具有能够彼此对齐的孔26a和26b。一旦对齐，旋拧元件或其他机械连接机构可以通过孔26a和26b定位从而将配合件22结合到主体构件11上。可选地，配合件22可以包括柱而不是孔，其进入主体11的孔26b中，并且可以与粘合剂或其他已知的粘合材料和技术一起使用。
由多个配合元件制造扭矩装置10的一个优点是单独的、离散的切割元件12可以在这些元件之间定位或安装。如图3所示，切割元件12(以及可选的分离器管14)可以放置在由扭矩装置10的配合件22和主体构件11内的凹陷33a和33b形成的空腔内。
图6示出了大致类似于之前描述的扭矩装置10的扭矩装置40的另一个实施例。然而，尽管图2-4的扭矩装置10将切割元件12定位在通道32的底部附近，但是在公共通道32分成护套通道16和植入线通道34之前，图6的扭矩装置40将切割元件12在护套通道16的前部/远端部分附近与护套通道16一体地安装。切割元件12的尖锐边缘12a以与所示的扭矩装置10相似的角度朝向远端，以在护套30经过时切割或分开护套30的一部分。由于切割元件12位于护套通道16内，而公共通道32已经分成护套通道16和植入线通道34，因此不需要分离器管14。
在操作中，扭矩装置10放置在患者体外的导引导管3的近端。导引导管在导丝2上通过患者脉管系统导航到目标治疗部位附近的适当位置。然后取出导丝2，使得导引导管3的内腔可用于传送输送护套30(注意，图1仅示出导引导管3中的护套30和导丝2两者，仅为了便于说明)。输送护套30通过导引导管3追踪并放置在治疗部位处或其附近。植入物5或者预先加载在输送护套30的远端附近，或者通过输送护套30被追踪。
植入物5安装在植入物输送线28上或连接到植入物输送线28。一旦输送护套30被放置，输送护套30就通过扭矩装置10取出。输送护套30向近端穿过公共通道32，被切割元件12切开，并且通过护套通道16轴向地歪斜远离植入物输送线28移动。在取出输送护套之前，可以可选地通过旋转旋拧元件18来固定植入物输送线28，使得夹头20压靠植入物输送线28，从而在取出输送护套30时将植入物5维持在患者内的相对固定位置。
部署之后，植入物输送线28可以充当用于追踪附加装置的导丝。在植入物5是EPD或过滤器的一个示例中，植入物5放置在目标治疗部位的远端。一旦EPD/过滤器被放置并且护套30被取出并且造成狭缝，植入物输送线28用作导丝以将支架或球囊追踪到治疗部位以治疗钙化区域。支架或球囊可以利用仍然放置的导引导管3作为导管，或者可以在植入物输送线28上追踪另一个输送导管。支架或球囊放置在EPD/过滤器的近端。支架或球囊扩张以支撑血管1，并且任何脱出的血栓被位于远端位置的EPD/过滤器捕获。手术后，在一个稍后时间，EPD或过滤器可以通过使用取回导管而取出，并将EPD/过滤器固定在取回导管上以取出装置。
其他实施例使用快速交换导丝系统。在一个示例中，导引导管3具有侧向端口以适应导丝2的进和出。因此导丝2不需要在导引导管3的整个长度上被追踪。导丝2穿过导引导管3的侧向端口放置，在导丝2上推动导引导管3。一旦导引导管3被放置，导丝2通过侧向端口被取出，并且推动输送护套30(以及容纳在其中的植入物5)穿过导引导管3到治疗部位。
其他装置使用快速交换导丝系统，其中植入物5本身包含端口以容纳导丝2。导丝2可以通过植入物5预加载，其中植入物5位于输送护套30内并且输送护套30定位在导引导管3内。可以在导丝2上推动植入物5和输送护套30到治疗部位。一旦位于治疗部位，通过在导丝2上拉回导丝2而取出导丝2。导丝2将通过植入物5取出，要么通过导引导管3的长度要么通过导引导管3的侧向端口。然后如上所述，将植入物输送线28用作额外植入物的导管。
植入物输送系统可用于输送多种植入物，例如EPD、过滤器、线圈、塞子、封堵器、支架、凝块回收器或其他植入物。上述使用实施例的方法详细描述了如何使用EPD的植入线作为输送额外植入物的机制，但是在使用除了EPD之外的植入物的情况下，也可以应用相同的原理。
经由输送护套30输送植入物5并且通过扭矩装置10的机制取出输送护套30以切割护套30并暴露植入物5也可以用于多种植入物。该技术的特征在于，通过压缩扭矩装置10上的夹头20来固定植入位置的能力以及通过切割输送护套30而暴露植入物5的能力。
本发明的方法和实施例的变型进一步包括使用旋拧元件18和夹头20的构造来锁定植入线28，并随后取出输送护套30，但不使用切割元件12。在这样的实施例中，植入物5处于固定位置，并且输送护套30将简单地通过扭矩装置10取出而不被切割。因此，可以使用除了没有切割元件12之外类似于图1-5的扭矩装置10的装置。则输送护套30通过护套通道16取出而不被切割。该实施例可用于多种植入物上，例如线圈、支架、EPD、过滤器、塞子、封堵器、凝块回收器或其他植入物。这些装置中的一个或多个固定或连接到植入物输送线28并通过输送护套30输送。然后可以取出输送护套30以暴露植入物。用户可以可选地通过压缩在输送线28上的夹头20来锁定植入物，以最小化输送操作期间植入物的移动。
本文描述的任何测量、图形、材料仅意味着本质上是说明性的，并不意味着特别限于字面上公开的内容。
虽然已经根据特定的实施例和应用描述了本发明，但是本领域的普通技术人员根据该教导可以产生另外的实施例和修改，而不背离要求保护的本发明的精神或超越范围。因此，应该理解的是，这里的附图和描述是通过举例的方式提供的，以便于理解本发明，不应该解释为限制其范围。

Claims (20)

1.一种植入物输送装置，包括：
具有内腔的输送护套；
连接到细长植入线的植入物；所述植入物和所述细长植入线的尺寸设计为通过所述输送护套部署；
扭矩装置，具有第一通道、切割元件以及第二通道，所述切割元件被定位以切割所述输送护套，所述第二通道从所述第二通道分裂开，以使得所述输送护套与所述细长植入线分离。
2.根据权利要求1所述的植入物输送系统，其特征在于，所述扭矩装置还包括夹持机构，所述夹持机构配置为防止所述细长植入线相对于所述扭矩装置移动。
3.根据权利要求2所述的植入物输送系统，其特征在于，所述夹持机构还包括夹头和与所述夹头选择性地接触的旋拧构件，以增加或减小所述夹头的内径。
4.根据权利要求3所述的植入物输送系统，其特征在于，所述旋拧构件被拧到所述扭矩装置的主体的近端上。
5.根据权利要求1所述的植入物输送系统，其特征在于，所述切割元件包括定位成朝向所述扭矩装置的远端的尖锐边缘。
6.根据权利要求1所述的植入物输送系统，其特征在于，所述第一通道在所述扭矩装置的近端和远端之间延伸。
7.根据权利要求6所述的植入物输送系统，其特征在于，所述第一通道进一步延伸穿过位于所述扭矩装置的近端附近的夹持机构。
8.根据权利要求7所述的植入物输送系统，其特征在于，所述第一通道延伸穿过所述夹持机构的夹头和旋拧构件。
9.根据权利要求1所述的植入物输送系统，其特征在于，所述植入物是栓塞保护装置。
10.一种用于植入物输送系统的扭矩装置，包括：
具有延伸穿过其中的第一通道的扭矩体；
布置在所述扭矩体中并且至少部分地位于所述第一通道中的切割元件；
第二通道，位于所述扭矩体中并且在所述切割元件附近连接到所述第一通道；所述第二通道远离所述第二通道延伸；
其中所述切割元件在穿过所述第一通道的护套上造成纵向狭缝，并且其中所述扭矩装置将具有所述纵向狭缝的所述护套引导到所述第二通道中，同时保持植入物输送线位于所述第一通道的所述护套中。
11.根据权利要求10所述的扭矩装置，还包括连接到所述第一通道的夹持机构，所述夹持机构可选择性地夹持所述植入物输送线。
12.根据权利要求11所述的扭矩装置，其特征在于，所述夹持机构还包括夹头和旋拧构件，所述旋拧构件选择性地与所述夹头接合，以增加或减小穿过所述夹头的通道的内径。
13.根据权利要求12所述的扭矩装置，其特征在于，所述旋拧构件被拧到所述扭矩体的近端上。
14.根据权利要求10所述的扭矩装置，其特征在于，所述切割元件在所述扭矩体中与所述第二通道朝向相反。
15.根据权利要求14所述的扭矩装置，其特征在于，所述切割元件还包括位于所述第一通道内的切割元件通道。
16.一种输送植入物的方法，包括：
使扭矩装置上的夹紧机构锁定细长植入线；所述植入线的远端连接到植入物；
通过所述扭矩装置向近端取出护套；所述护套至少部分地设置在所述细长植入线上；
利用所述扭矩装置在所述护套中造成纵向狭缝部分；以及
将所述护套的所述纵向狭缝部分与所述细长植入线分开。
17.根据权利要求16所述的方法，其特征在于，所述锁定夹持机构还包括将所述夹持机构的旋拧构件拧到所述夹持机构的夹头上。
18.根据权利要求17所述的方法，其特征在于，所述造成纵向狭缝部分还包括使所述护套穿过所述扭矩装置中的切割元件。
19.根据权利要求18所述的方法，其特征在于，所述分离所述纵向狭缝部分还包括将所述输送护套从第一通道引导到远离所述细长植入线的第二通道。
20.根据权利要求19所述的方法，其特征在于，所述向近端取出所述护套还包括使所述植入物在患者体内扩张。
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CN107847243B (zh) 2021-06-01
US20170042548A1 (en) 2017-02-16
US10492938B2 (en) 2019-12-03
JP6735814B2 (ja) 2020-08-05
EP3334354A4 (en) 2019-04-03
JP2018522681A (ja) 2018-08-16
US11406520B2 (en) 2022-08-09
EP3334354B1 (en) 2021-03-03
US20200046535A1 (en) 2020-02-13
WO2017027740A1 (en) 2017-02-16
EP3334354A1 (en) 2018-06-20

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