CN1543367A - 带有拴系系统的植入导管 - Google Patents

带有拴系系统的植入导管 Download PDF

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CN1543367A
CN1543367A CNA02816167XA CN02816167A CN1543367A CN 1543367 A CN1543367 A CN 1543367A CN A02816167X A CNA02816167X A CN A02816167XA CN 02816167 A CN02816167 A CN 02816167A CN 1543367 A CN1543367 A CN 1543367A
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杰弗里·韦尔奇
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
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Abstract

用于植入装置的导管插入器械提供有装置系绳。该器械包括装置传送管，该装置传送管提供了用于使植入装置通过病人的脉管通向体腔内的通路。该植入装置由管形推杆携带或推过装置传送管。植入装置拴系在穿过推杆管腔的线上。在展开之后，该植入装置可以通过拉动系绳而退回到装置传送管内，以便重新定位或取出。

Description

带有拴系系统的植入导管
本申请要求美国临时申请No.60/306178的优先权，该临时申请No.60/306178的申请日为2001年7月18日，该文献整个被本文参引。
发明背景
发明领域
本发明涉及一种用于心房附件中的植入装置的器械。该植入装置可以用于过滤或以其它方式改变在心脏的心房附件和相应心房之间的血流，以便防止血栓离开心房附件进入人体的血液循环系统。特别是，本发明涉及一种用于经皮肤传送和植入该装置的器械。
相关技术的说明
多种心脏病(例如冠状动脉疾病、二尖瓣疾病)对病人的心脏有各种不利影响。某些心脏病例如二尖瓣疾病的不利影响是心房(或心耳)纤颤。心房纤颤导致心脏输出降低。血栓栓塞(即血凝块颗粒)现象很可能与心房纤颤一起发生，而左心房附件(LAA)通常是血栓(颗粒)源。
在LAA中形成血栓(即血凝块)可能是由于在纤颤以及LAA不充分排空时的产生的郁积。郁积在心房附件中的血液将导致形成血凝块。血凝块会自己累积和增大。血凝块的、或大或小的断片可能断裂，并从心房附件进入心房中。然后，该血凝块断片可以进入身体的血液循环中，并在远处阻塞血流。
血凝块断片从心房附件进入身体血流中将产生严重的医学问题。从左心房和心室流出的血液将流向心肌、大脑和其它身体器官，从而向它们供给所需的氧和其它营养物质。由形成于左心房附件中的血凝块产生的栓塞可能堵塞动脉，血液通过该动脉流向身体器官。该堵塞将使器官组织丧失了它们的正常血流和氧供给(局部缺血)，并根据所涉及的身体器官而引起局部缺血现象，例如心脏病(心肌缺血)和中风(大脑组织缺血)。
因此，重要的是找到一种防止血凝块形成于左心房附件中的方法。重要的是找到一种方式以防止由可能形成于心房附件中的血凝块所产生的断片或血栓通过血流传播到心肌、大脑或其它身体器官中。
近来提出的一些治疗方法涉及将塞子型装置植入心房附件中，以便阻塞血液从该心房附件中流出。
用于避免血栓栓塞现象(例如心脏病、中风和其它局部缺血现象)的另一治疗方法涉及将有害血栓从流出心房附件的血液中滤出。本申请人的共同待审美国专利申请No.09/428008、No.09/614091、No.09/642291、No.09/697628、No.09/932512、No.09/960749和No.10/094730介绍了可以植入心房附件中以便过滤从该心房附件中流出的血流的过滤装置，这些文献都被本文参引。
普通的导管插入方法(包括经中隔的步骤)可以用于将该装置植入心房附件中。将小直径的导管传送管穿过病人的脉管系统，以便提供通向病人的心房附件的管道或通路。植入装置通常有弹性或可压缩结构。该结构使得该装置能够可逆压紧成适于插入该较小直径导管传送管的较小尺寸。压紧的装置安装在导线或推杆上，并通过该导管传送管运动至在病人心腔内的展开位置。然后，通过遥控操纵，该压紧装置可以就地膨胀，并与推杆或导线脱开，以便作为心房附件植入件。
心房植入治疗的成功取决于植入装置在合适位置以合适方向(相对于心房附件)展开。为了有效，装置必须能够拦截流过心房附件的全部血流。例如，为了成功植入过滤装置，该装置应当定位和定向成使心房附件的血流全部通过装置的过滤元件，因此，在装置周围没有渗漏。
不过，用于植入传送的、经皮肤的导管插入传送技术(它通常依赖于操作人员的技巧)不能在第一次时就将装置充分精确地布置成合适方向。装置传送导管的疏忽运动或者位置或方向的不稳定都可能使得心房附件植入装置很难精确布置。有时，以合适方向将装置布置在合适展开位置可能需要重复进行位置探测或调节。而且，合适布置的压紧装置也可能在随后的就地膨胀或脱开过程中而变得错位或方向错误。在某些情况下，甚至可能希望使传送的装置退出。
本申请人的共同待审的美国专利申请No.09/932512公开了一种具有定位装置或引导件的导管插入器械，该定位装置或引导件能够进行位置检测，并可重新调节传送的植入装置的位置。现在考虑给出一种另外的导管插入器械，该导管插入器械的特征是能够控制植入装置的回收和重新定位。
发明简介
本发明提供了一种导管插入器械，该导管插入器械有这样的系统，即植入装置可以通过该系统而在装置的传送和展开过程中安装在系绳上。该导管插入器械包括传送管，该传送管提供了用于使植入装置通过病人脉管进入体腔内的管道或通路。植入装置可以穿过该传送管运动，并从该传送管的远端推出或释放，以便在体腔内展开。普通机构例如管形推杆或杆可以用于使装置通过导管传送管。
拴系系统提供了对从导管传送管的远端推出或释放到病人体腔内的植入装置的远处机械控制。对展开后的装置的机械控制使得医师能够根据需要回收和重新定位植入装置。
在本发明的一个实施例中，拴系系统包括与装置推杆或杆连接的线分配毂套。该拴系系统可以用于具有合适线连接特征例如孔眼的植入装置(或者能够与线连接特征配合的植入装置)。柔性线(或线)通过该毂套来分配。分配的线穿过推杆和植入装置的线连接特征，以便形成线环。该线环的线支脚穿过管形装置推杆而从毂套伸向植入装置。另一线支脚从该植入装置往回伸向毂套。毂套可以有能够安装或固定线端的锚固杆或固定件，以便牢固固定线环的一个支脚。毂套还可以有另一固定装置，例如可调节的线锁，以便在植入件导管插入过程中根据需要保持线环的另一“自由”支脚。
在植入过程中，拴系的植入装置利用推杆而通过导管传送管。附加长度的线也可以进行分配，以便当需要时在植入装置穿过并离开导管传送管时延长线环。即使在植入装置已经从导管传送管中推出并在体腔内展开之后，植入装置仍然安装或系在线环上。
通过在两个线支脚牢固固定在毂套中的情况下使推杆退回，可以使例如定位并不令人满意的展开植入装置退回到导管传送管内。该退回的装置可以重新展开，或者合适时可以完全退出。已经满意地定位的植入装置可以这样释放，即通过首先释放毂套中的线锁，以便释放线环的一个线端，然后使推杆退回，从而使线环的自由端滑过植入装置的线连接特征。
拴系系统的其它实施例可以有其它的线结构(以及线固定装置)，它能够对拴系的植入装置进行机械控制。
通过附图和下面的详细说明，可以更清楚本发明的其它特征、性质和各种优点。
附图的简要说明
图1是心脏的局部剖视图，表示了利用经中隔的导管插入步骤而进入左心房附件的普通导管。
图2是具有装置拴系系统的导管插入器械的示意剖视图，根据本发明，该装置拴系系统包括线分配毂套，该线分配毂套与管状推杆相连，该管状推杆用于根据本发明的原理使植入装置通过导管传送管。还有，拴系在线环上的过滤植入装置实例表示为展开在心房附件中。线环的两个线支脚分别表示为锚固在锚固杆上以及锚固在线分配毂套中的线锁定机构上。
图3是图2的导管插入器械的示意剖视图，表示了根据本发明原理释放线锁定机构，以便释放线环的支脚，从而准备解开该展开的植入装置。
优选实施例的说明
用于过滤或以其它方式改变在心房附件和它的心房之间的血流的植入装置可以安装在推杆或杆上，然后通过导管传送管而经皮肤传送至该附件，该导管传送管插入通向心脏的血管中。
例如，图1表示了导管21，在进入左心房附件13之前，该导管21穿过股静脉(未示出)插入，并通过下腔静脉18进入心脏的右心房，然后通过卵圆窝19或通过中隔29进入左心房11。也可选择(图1中未示出)，导管21可以通过主动脉12进入心脏的左心室16，然后通过二尖瓣17到达左心房附件13。安装在导管21上的植入装置(未示出)可以用于防止由该左心房附件产生的血栓30进入心房11中。
植入装置通常包括具有合适特征(例如辐射不透明性)的材料，该材料使得可以在导管插入过程中和之后利用外部成像技术(例如射线成像术、x射线透视检查术、超声波心动描计术和超声波)来检测体内装置的位置。不过，穿过病人的脉管并越过心中隔的导管传送管的迂回通路可能使得植入装置很难精确布置，即使操作医师能够在导管插入过程中利用外部成像技术来监测植入装置的位置。
本发明提供了一种导管插入器械，该导管插入器械除了已知导管插入器械(例如在美国专利申请No.09/960749和No.60/351898中所述的前述导管插入器械)的普通特征之外还有装置拴系系统。与已知导管插入器械共有的基本特征是装置传送管，该装置传送管提供有用于将植入装置插入病人体内的管道或通路。与已知导管插入器械共有的另一基本特征是用于携带或使植入装置通过传送管运动的机构，例如推杆或杆。应当知道，本发明的导管插入器械总体有一个或多个套装的管、线或杆以及其它特征(例如在美国专利申请No.09/960749中所述的定位引导件)。不过，为了使本发明的说明清楚，并为了能够简化理解本发明，将只介绍本发明导管插入器械的两个前述基本普通特征。
在本发明的拴系系统中，植入装置拴系在一定长度的柔性线上，该柔性线穿过管形推杆或杆延伸。该拴系线使得操作医师能够在将植入装置从导管传送管推出到体腔内之后保持对该植入装置的机械控制。对展开后的装置的该机械控制使得医师能够根据需要回收和重新定位植入装置。
拴系系统可以用于具有合适线连接特征例如孔眼的植入装置(或者可以与合适线连接特征配合的植入装置)。还应当知道，装置材料具有合适特征(例如辐射不透明性)，该特征使得可以在导管插入过程中和之后利用外部成像技术(例如射线成像术、x射线透视检查术、超声波心动描计术和超声波)来监测体内装置的位置。可以采用本发明的拴系系统的装置实例是可逆膨胀的过滤植入装置，该过滤植入装置具有弹性结构，如美国专利No.09/428008、No.09/614091、No.09/642291、No.09/697628、No.09/932512、No.09/960749和No.10/094730所述。应当知道，拴系系统也可以采用任意其它类型的、可通过导管传送的植入装置。
在本发明的一个实施例中，拴系系统包括线分配毂套，该线分配毂套与管形推杆或杆的远端相连。柔性线(线、绳或弦)分配在该毂套中。该线可以由任意合适材料制成，例如金属、聚合物、或者它们的组合。合适强度的线可以由单股线制成，或者由多股线材料制成。线穿过管形推杆，并从推杆的近端伸出。从推杆中伸出的分配线穿过植入装置的线连接特征，并通过推杆返回到毂套。这样形成的线环具有从该毂套伸向植入装置的线支脚以及从该植入装置返回毂套的另一支脚。线环的两端可以牢固地锚固或固定在毂套中的锚固固定件上。通过适当地调节线环支脚的长度，可以将拴系的装置牢固保持为抵靠(和装载在)推杆的远端。
在导管插入植入过程中，在远端载有拴系的装置的推杆可以用于使植入装置通过由导管传送管形成的通路而从病人体外传送到体腔内。例如，该植入装置可以是自膨胀装置。通过推动装置经过导管传送管的远端，该装置将在体腔内展开。即使在植入装置从导管传送管中推出之后，它仍然系在线环上。
外部成像技术可以用于验证展开的装置的位置。可选的诊断方法(例如对病人生理参数的电子监测)也可以用于评估该展开装置的合适性。
例如定位或定向并不令人满意的展开植入装置可以通过将推杆从导管传送管中拉出而退回到导管传送管内。推杆的向后运动使得线环将拴系的装置机械拉入导管传送管内。因为植入装置的弹性结构，该植入装置在退回到传送管内时压缩至它的紧凑尺寸。操作医师可以尝试通过将推杆向前运动并再次将退回的装置从导管传送管中推出，从而使退回的装置能够在更令人满意的位置或沿更令人满意的方向重新定位和重新展开。在试图使退回的装置重新展开之前，导管传送管自身可以根据需要进行合适的重新定位或稳定。
也可选择，当医学上合适时，可以通过将推杆完全从导管传送管中拉出而使退回的装置从病人身体中取回。
令人满意地展开的植入装置可以这样解开系绳，即通过首先释放在毂套中的线锁以便释放线环的一个线端，然后使推杆退回，以便使线环的自由端滑过植入装置的线连接特征。
图2示意表示了具有装置拴系系统的导管插入器械的一部分。导管插入器械200包括空心的管形杆或推杆210以及导管装置传送管205。导管传送管205和推杆210可以由包括金属和聚合物材料的任意合适材料制成，该材料例如不锈钢和PTFE(例如Teflon)。导管传送管205可以用于形成通向体腔的、经皮肤的通道。推杆210设计成穿过导管装置传送管205滑动。推杆210可以用于推动或运送压紧的植入装置通过装置传送管205进入体腔内。
例如，图2示意表示了传送管205，该传送管205形成通向心房235的管道。而且，图2表示了过滤植入装置230，该过滤植入装置230穿过装置传送管205推出，并在病人的左心房附件240中展开。植入装置230在它的远端提供有孔眼235。
线分配毂套220与推杆210的近端机械连接。毂套220具有容器状结构，并可以由包括金属和聚合物材料的任意合适材料制成。线杆224和线锁固定件222布置在毂套220的内壁上。线锁固定件222包括杆222a、222b和222c。毂套220可以提供有可去除的接近盖体(未示出)，以便接近该毂套220的内部。
植入装置由线缆280系住。线缆280例如通过普通的螺钉和垫圈装置(未示出)而固定在线杆224上。例如，线缆280可以为聚合物或尼龙绳。也可选择，线缆280可以由其它合适的天然或合成纤维制成。线缆280穿过推杆210的管腔而从线杆224伸向植入装置230。线缆280穿过布置在装置230上的孔眼，并穿过推杆230的管腔而返回毂套220。线缆280的返回端可以卷绕在线锁杆222a-222c上，以便锚固该线缆280，从而可以将植入装置230牢固系在推杆210的远端上。在毂套220的可选设计中，线锁222可以包括活动操作杆、线轴、辊、或者其它机械结构，以便握住、夹住、或者以其它方式保持和锚固线缆280的返回端。这样，植入装置230可以系在由线缆280形成的线环上，该线环有从线杆224伸向植入装置230的支脚280a以及从该装置230伸向毂套220的支脚280b。在植入装置230从导管传送管205中推出并在心房附件240中展开之后，它仍然保持拴系，如图2所示。
为了解开植入装置230，支脚280的端部可以从杆222a、222b和222c上解开，以便将支脚280b从线锁222上释放。然后，推杆210可以(与相连的毂套220一起)从导管传送管205中往回拉出。该向后运动使得线缆280滑出孔眼235，从而解开装置230。图3示意表示了图2中所示的导管插入器械200部分在解开时的情况。在图3中，线缆支脚280n表示为自由状态，并没有系在线锁222上。推杆210表示为已经向后运动到导管装置传送管205内，并与装置230脱开。而且，推杆210向后运动至导管装置传送管205内将使线缆280的自由端完全滑出孔眼235(未示出)。
应当知道，前述只是举例说明了本发明的原理，在不脱离本发明的范围和精神的情况下，本领域技术人员可以进行各种变化。应当知道，这里所用的术语如“远”和“近”、“向前”和“向后”、“前”和“后”、以及其它方向或方位术语只是为了方便，这些术语并不是用于固定或绝对方位。

Claims (26)

1.一种导管插入器械，用于将装置植入体腔内，它包括：
传送管，用于形成使所述装置通向所述体腔的管道；
推杆，用于使所述装置通过所述传送管；以及
可释放的系绳，该系绳安装在所述装置上，用于在该装置布置在所述体腔内之后对所述装置进行机械控制。
2.根据权利要求1所述的器械，其中：所述推杆包括空心管。
3.根据权利要求1所述的器械，其中：所述系绳包括从以下组中选定的材料：金属、聚合物、天然纤维、合成纤维、以及它们的任意组合。
4.根据权利要求1所述的器械，其中：所述推杆与布置在所述推杆端部的毂套连接，且所述系绳从所述毂套伸向布置在所述推杆的另一端上的所述植入装置。
5.根据权利要求4所述的器械，其中：所述毂套包括线锚固固定件，所述系绳包括线环，该线环有固定在所述线锚固固定件上的线端。
6.一种用于将导管植入装置定位在体腔内的方法，包括：
提供一种导管插入器械，该导管插入器械包括：
传送管；
推杆，用于使所述装置通过所述传送管；以及
可释放的系绳，该系绳安装在所述装置上，用于在该装置布置在所述体腔内之后对所述装置进行机械控制；
使用所述传送管来形成用于使所述装置通向所述体腔的管道；
将所述系绳安装在所述装置上；
使用所述推杆来使所述被拴系的装置通过所述传送管；以及
将所述被拴系的装置推入体腔内。
7.根据权利要求6所述的方法，还包括：脱开所述系绳。
8.根据权利要求6所述的方法，还包括：评估所述推出的装置的位置。
9.根据权利要求8所述的方法，还包括：使用所述系绳，以便以机械方式使所述推出的装置退回到所述传送管内。
10.根据权利要求8所述的方法，还包括：将所述退回的装置推入所述体腔内，以便重新定位所述装置。
11.根据权利要求6所述的方法，其中：所述提供导管插入器械还包括使所述推杆具有空心管形结构。
12.根据权利要求6所述的方法，还包括：将所述可释放的系绳可释放地锚固在所述推杆的一端处。
13.一种器械，用于将装置植入心房附件内，它包括：
传送管，用于形成穿过身体的脉管的管道，该管道用于使所述装置通向所述心房附件；
杆，用于通过所述传送管输送所述装置，其中，所述杆包括装置系绳，用于在该装置布置在所述体腔中之后对所述装置进行机械控制。
14.根据权利要求13所述的器械，其中：所述杆包括空心管。
15.根据权利要求13所述的器械，其中：所述系绳包括从以下组中选定的材料：金属、聚合物、天然纤维、合成纤维、以及它们的任意组合。
16.根据权利要求13所述的器械，其中：所述杆与布置在所述杆端部的毂套连接，且所述系绳从所述毂套伸向布置在所述杆的另一端上的所述植入装置。
17.根据权利要求16所述的器械，其中：所述毂套包括线锚固固定件，所述系绳包括线环，该线环有固定在所述线锚固固定件上的线端。
18.一种用于将装置植入心房附件中的方法，包括：
提供一种导管插入器械，该导管插入器械包括：
传送管，用于形成穿过身体的脉管的管道，该管道用于使所述装置通向所述心房附件；
杆，用于通过所述传送管输送所述装置，其中，所述杆包括装置系绳，用于在该装置布置在所述心房附件中之后对所述装置进行机械控制；
使所述传送管穿过皮肤通过血管向所述附件前进；
将所述系绳安装在所述装置上；
使用所述杆来使所述拴系的装置通过所述传送管；以及
将所述拴系的装置推入所述附件内。
19.根据权利要求18所述的方法，还包括：解开所述推出装置。
20.根据权利要求18所述的方法，还包括：评估所述推出的装置的位置。
21.根据权利要求20所述的方法，其中：所述评估包括使用外部成像技术。
22.根据权利要求21所述的方法，还包括：利用所述评估来决定使所述推出的装置退回到所述传送管内。
23.根据权利要求18所述的方法，还包括：使用所述系绳，以便使所述推出的装置机械退回到所述传送管装置内。
24.根据权利要求23所述的方法，还包括：将所述退回的装置推入所述附件内，以便重新定位所述装置。
25.根据权利要求18所述的方法，其中：所述提供导管插入器械还包括使所述杆具有空心管形结构。
26.根据权利要求18所述的方法，还包括：将所述系绳可释放地锚固在所述推杆的一端处。
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CN104825247B (zh) * 2009-07-29 2017-05-03 C·R·巴德公司 管式过滤器
CN108354589A (zh) * 2013-03-15 2018-08-03 微创医学科技有限公司 可植入的锚固件

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CA2454017A1 (en) 2003-01-30
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WO2003008030A2 (en) 2003-01-30
WO2003008030A3 (en) 2003-04-03
EP1406689A2 (en) 2004-04-14
US20030023262A1 (en) 2003-01-30
IL159833A0 (en) 2004-06-20
US7011671B2 (en) 2006-03-14

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