CN103842023B - 包括引导附件的植入系统 - Google Patents

包括引导附件的植入系统 Download PDF

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CN103842023B
CN103842023B CN201280048554.8A CN201280048554A CN103842023B CN 103842023 B CN103842023 B CN 103842023B CN 201280048554 A CN201280048554 A CN 201280048554A CN 103842023 B CN103842023 B CN 103842023B
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CN103842023A (zh
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M·D·邦纳
V·P·尼科斯基
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Medtronic Inc
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/37205Microstimulators, e.g. implantable through a cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3756Casings with electrodes thereon, e.g. leadless stimulators

Abstract

一种用于结合植入系统的导丝和导管使用的引导附件有利于在相对紧凑的治疗递送装置的治疗发生器被保持在导管的远端部分内并且导管、装置和引导附件沿导丝被推进时将所述装置的细长且柔性的导体传送至例如在心脏静脉系统内的植入部位。引导附件包括形成管腔的螺旋延伸的壁,所述装置导体和导丝在所述管腔内延伸。在将导管、引导附件和装置推进到植入部位之后,优选地通过向近端拉动附接到壁的近端的张力线而将螺旋延伸的壁从装置导体周围退绕,以便移除。

Description

包括引导附件的植入系统
技术领域
本发明涉及用于植入治疗递送装置的系统,并且更具体地涉及该系统的引导附件和使用方法。
背景技术
传统的可植入的心脏起搏器包括脉冲发生装置,一个或多个细长的引线联接到该脉冲发生装置。该装置通常被植入远离心脏的皮下囊袋中,并且所述一个或多个引线中的每一个从该装置延伸至对应电极,联接到该电极并且定位在起搏部位(心内膜或心外膜)处。有时与细长引线相关联且为本领域的技术人员所熟知的机械性并发症和/或MRI相容性问题推动了心脏起搏装置的发展,该装置被完全容纳在相对紧凑的包装内以便紧邻起搏部位(例如,在心脏的右心室(RV)内)植入。参照图1,示出了这样的装置100,其中起搏/感测电极111、112形成于外壳101的外表面上,外壳101气密地容纳包括脉冲发生器电子器件和电源的脉冲发生器。外壳101优选地由诸如钛的生物相容性和生物稳定性金属形成,除了在电极112形成为外壳101的暴露部分处之外,该金属上覆有绝缘层,例如医用级聚氨酯或硅氧烷。诸如本领域的技术人员已知的任一种的气密性贯通组件(未示出)将电极111联接到容纳在外壳101内的脉冲发生器。
图1进一步示出了固定构件115,其在电极111附近安装到外壳101的端部,以便在RV的尖端处抵靠心内膜表面固定或固连电极111。然而,在一些患者中,起搏刺激如果被递送至右心房部位或左心室部位则可以更有效。因此,已经开发出用于这些备选的植入部位的相对紧凑的起搏装置的替代形式,并且需要对应的植入物系统和方法。
发明内容
本发明的实施例和方法有利于植入一种相对紧凑的治疗递送装置,该装置包括从装置的治疗发生器延伸的细长且柔性的带绝缘导体。所述方法采用引导附件,其结合导管和导丝,以便于在装置的治疗发生器被保持在导管的远端部分内时将导体传送到植入部位,例如经由冠状窦口进入心脏静脉系统。引导附件包括形成管腔的螺旋延伸的壁,当发生器被保持在发生器的远端部分内时,装置的导体可以在管腔内延伸。导管包括优选地与远端部分并排地延伸的管腔,以用于传送导丝;并且引导附件的管腔也允许与装置的导体并排地传送导丝,使得导管和引导附件与装置一起可以沿导丝被推进至植入部位。在将导管、引导附件和装置推进到植入部位之后,优选地通过向近端拉动附接到螺旋延伸的壁的近端的张力线,以将壁朝导管的远端部分拉引,由此使壁从导体周围退绕,从而将引导附件的螺旋延伸的壁从装置的导体周围移除。
附图说明
以下附图说明了本发明的特定实施例,并且因此并不限制本发明的范围。附图未按比例绘制(除非有说明)并且旨在用于结合以下具体实施方式中的解释使用。下面将结合附图描述各实施例,在附图中,相同的标号表示相同的元件,并且
图1是示出植入的心脏刺激装置的示例的示意图;
图2A是另一种可植入的治疗递送装置的平面图;
图2B-2C是示出可以植入图2A的装置的替代部位的示意图;
图3A是与图2A的装置并排的、根据一些实施例的植入物系统的平面图;
图3B是根据一些实施例的植入物系统的远端部分的局部剖开的平面图,装置和导丝被装载到该系统内;
图4是图3B的远端部分的立体图;以及
图5是根据一些方法实施例的植入物系统的局部剖开的平面图,其中其引导附件被移除。
具体实施方式
以下的详细描述在本质上为示例性的,而并非意图以任何方式限制本发明的范围、适用性或构型。相反,以下描述提供了实用的示例,并且本领域的技术人员将认识到,示例中的一些可以具有合适的替代方案。
图2A是本发明的植入方法和系统适用的示例性的可植入的治疗递送装置200的平面图。图2A示出了该装置200包括治疗发生器210、联接到治疗发生器210的固定构件215、以及经由细长而柔性的带绝缘导体230联接到发生器210的治疗递送元件213。装置200优选地尺寸设计成完全植入到心脏部位处,其中示例性的尺寸如下:发生器210的长度在大约20mm和大约25mm之间;发生器210的直径在大约5mm和大约7mm之间;导体230的长度优选地在大约20mm和大约80mm之间;并且导体230的直径优选地在大约0.025英寸(0.6mm)和大约0.035英寸(0.9mm)之间。装置200可以适于递送任何类型的合适治疗,例如,装置200可以类似于上述装置100,其中,发生器210为容纳在气密性封罩/外壳中的起搏脉冲发生器,并且治疗递送元件213为电极,虽然只是与发生器210错开导体230的长度的电极。参照图2B-C,示出了装置200的替代性植入部位,所述部位通过导体230的长度而变得有利。
图2B是心脏的前视图,其中右心房壁的一部分被切去;并且图2C是心脏的后视图,其中冠状静脉系统的一部分被切去。图2B示出了发生器210,其在冠状窦口CSos附近固定在右心房RA内,以使得导体230延伸进入冠状窦口CSos,以便将治疗递送元件213(未示出)定位在冠状窦CS内,或在其上游的另一个静脉中,如果导体230的长度允许的话。图2C示出了冠状窦CS和从其向远端延伸的第一冠状静脉CV1。在图2C中,发生器210被示出为固定在冠状窦CS的近端部分内,并且导体230被示出为从冠状窦CS延伸,以使得递送元件213位于静脉CV1内。如果递送元件213为电极,那么植入物的图示位置可适合左心室起搏;或者,出于相同的目的,递送元件213可以被定位在其它冠状静脉CV2、CV3、CV4中的任一个内(图2B)。根据本发明的方法和实施例,诸如后续附图中所示的系统600之类的植入系统包括引导附件500,以有利于将装置200递送至任何上述植入位置。
图3A是植入系统600的平面图;并且图3B是具有剖开部分的植入系统600的远端部分的平面图。图3A示出了与植入系统600并排的装置200,并且植入系统600包括导管300、导丝400和引导附件500。导丝400可以是介入心脏病学和电生理学领域的技术人员已知的任何合适类型,优选地在其远端顶端403附近具有在0.010英寸和0.018英寸之间的直径;并且导管300可以根据本领域已知的构造方法被构造成具有固定形状的远端区段或可操纵的远端区段。导管300被示出为包括细长轴320,其从导管300的近端301延伸至导管300的远端部分330。图3B示出了通向远端部分330内部的导管轴320的管腔30,该内部保持装置200的发生器210。虽然未示出,但是管腔30延伸至导管300的近端301。图3B进一步示出导管300包括导丝管腔34,导丝管腔34优选地仅大致沿远端部分330的长度延伸。然而,根据一些备选实施例,导丝管腔34可以沿导管轴320进一步向近端延伸,或者可以在导管轴320内与管腔30并排地延伸,并且通入远端部分330的内部。图3A-B进一步示出了引导附件500,其包括螺旋延伸的壁550和附接到壁550的张力线540;张力线540从壁550向近端延伸且进入导管300的远端部分330,然后沿着导管轴320的长度延伸且延伸出导管300的近端301。张力线540优选地由相对高抗张强度的聚合物纤维(例如聚酯)形成,其例如通过用绳结栓系而附接到壁550的近端501。根据图示实施例,张力线540优选地沿着轴320的长度容纳在管腔30内。根据一些附加实施例,管腔30可以容纳张力线540和导丝400,从而无需管腔34。
进一步参照图3A-B,装置200的发生器210可以沿箭头L1的方向通过导管300的远端开口装载到导管300的远端部分330内,并且细长且柔性的带绝缘导体230的远端203可以沿箭头L2的方向通过管腔55的近端开口551被装载到管腔55(图4)内,管腔55由引导附件500的螺旋延伸的壁550形成。在装载装置200之前或之后,导丝400可以分别沿例如箭头L3和L2的方向被装载到导管的管腔34中和引导附件500的管腔55内。因此,管腔55的直径尺寸设计成在其中并排地容纳导丝400和装置200的导体230,如图3B和图4所示;并且导丝400能与导体230在管腔55内并排地滑动。而且,管腔55的尺寸允许螺旋延伸的壁550和导体230沿导丝400一起移动。螺旋延伸的壁550可由弹性的生物相容性聚合物和弹性的生物相容性金属中的一种或组合的螺旋带形成,其中所述带优选地具有矩形横截面或圆形横截面。或者,壁550可由螺旋切割的聚合物管形成。根据一些实施例,壁550的厚度优选地在大约0.007英寸(0.2mm)和大约0.02英寸(0.5mm)之间。壁550的相邻匝能彼此分离,使得当拉力经由张力线540被施加例如到近端501时,壁550退绕,如下文更详细地描述的。
根据本发明的一些方法,在使用本领域的技术人员已知的导丝操纵技术,从经皮进入部位且在导管300和引导附件500之前,将导丝400的远端顶端403经静脉推进至右心房RA(图2B)并进入冠状窦CS而到达目标植入部位附近的位置之后,其中装载有装置200的导管300和引导附件500沿导丝400被推进至植入部位,例如,如图4所示。根据一些替代方法,独立于导管300、装置200和附件500,导丝400被经静脉推进至植入部位,然后导丝400的近端401沿箭头BL的方向(图3A)经由引导附件管腔55的远端开口553被重新装载进入引导附件管腔55内,然后经由导丝管腔34的远端开口343(图3B)进入导丝管腔34内,然后在导管300、附件500和装载的装置200在导丝400上被推过而至植入部位之前离开导丝管腔34的近端开口341。参照由图2B-C所示的植入部位,可以理解,当保持住发生器210的导管的远端部分330在冠状窦口CSos的近端内被推进时,引导附件500可用于并排地保持导体230和导丝400以有利于将导体230传送到冠状窦CS内,并且在必要时(根据装置200的治疗递送元件213)在例如CV1、CV2、CV3或CV4的静脉中的一个的上游。一旦治疗递送元件213被定位在目标部位处,就将螺旋延伸的壁550的近端501朝远端部分330的远端开口333且沿图4的箭头D的方向从远端开口333向近端拉引,从而使壁550从装置200的导体230周围退绕,通过这种方式移除引导附件500,例如,如图5所示。
根据图5所示实施例,引导附件500的张力线540被用来通过例如从线540的近端541沿箭头P的方向施加拉力而使螺旋延伸的壁550退绕;退绕的壁550随后被拉入容纳张力线540的同一管腔30内。根据本发明的替代方法,其它装置可用来沿箭头D的方向拉引壁550的近端501,从而使壁550从导体230周围退绕;例如,可以从导管300部署带钩的线材或相对的钳口以接合壁550的近端501并将其拉入导管300内。进一步参照图5,虚线示出可选的推动构件,其可用来刚好在沿箭头D的方向拉入螺旋延伸的壁550的近端501之前或优选地结合该操作将发生器210从导管的远端部分330推出。应该指出的是,虽然图5示出已将导丝400从导管300的管腔34且从引导附件500的管腔55移除(即,从植入部位往回拉),但是根据替代方法,在引导附件500的壁550被退绕和移除时,导丝400可以保持在管腔34、55两者内,或者,在壁550被退绕和移除时,导丝400可以被从管腔55拉出,但保持在管腔34中。
在上述详细描述中,已参照具体实施例描述了本发明。然而,可以理解,在不脱离所附权利要求中阐述的本发明的范围的情况下,可以进行各种修改和改变。

Claims (11)

1.一种包括导丝、导管和引导附件的用于植入治疗递送装置的系统,所述装置包括治疗发生器、治疗递送元件、以及将所述治疗发生器联接到所述治疗递送元件的细长且柔性的带绝缘导体;所述导管包括尺寸设计成适合所述导丝的传送的管腔和尺寸设计成保持所述装置的所述治疗发生器的远端部分,所述远端部分具有远端开口,当所述远端部分保持所述治疗发生器时,所述装置的所述细长且柔性的带绝缘导体通过所述远端开口延伸到所述远端部分之外且大体上向所述远端部分远端延伸;并且所述引导附件包括:
螺旋延伸的壁,所述螺旋延伸的壁形成管腔,所述管腔沿一定长度从其近端开口延伸至其远端开口,所述管腔的直径尺寸设计成在其中并排地容纳所述导丝和所述装置的所述细长且柔性的带绝缘导体,使得所述导丝能在所述管腔内与所述导体并排地滑动,并且使得所述壁和所述导体能一起沿所述导丝移动;以及
张力线,所述张力线附接到所述壁的近端,所述张力线的长度大于所述植入物导管的长度;并且
其中所述螺旋延伸的壁的相邻匝能彼此分离,使得当所述装置的所述导体在所述管腔内延伸时,在通过所述张力线在近端方向上施加拉力之后,所述壁从所述导体周围退绕。
2.根据权利要求1所述的系统,其特征在于,所述导管的所述管腔与其所述远端部分并排地延伸,并且包括均邻近所述远端部分的近端开口和远端开口。
3.根据权利要求1所述的系统,其特征在于,所述导管包括另一个管腔,并且所述引导附件的所述张力线在所述另一个管腔内延伸。
4.根据权利要求3所述的系统,其特征在于,所述另一个管腔通入所述导管的所述远端部分,并且当所述远端部分保持所述治疗发生器时,所述张力线与所述装置的所述治疗发生器并排地延伸。
5.根据权利要求3所述的系统,其特征在于,所述另一个管腔的尺寸设计成,在通过所述张力线施加所述拉力以使所述壁退绕时,接纳所述引导附件的所述螺旋延伸的壁。
6.根据权利要求1所述的系统,其特征在于,所述引导附件的所述螺旋延伸的壁由螺旋切割的聚合物管形成。
7.根据权利要求1所述的系统,其特征在于,所述引导附件的所述螺旋延伸的壁由下列中的一种或组合的螺旋带形成:弹性聚合物和弹性金属。
8.一种用于与导丝和导管结合使用以有利于将治疗递送装置的一部分传送至植入部位的引导附件;所述装置包括治疗发生器、治疗递送元件、以及将所述治疗发生器联接到所述治疗递送元件的细长且柔性的带绝缘导体;所述导管包括尺寸设计成保持所述装置的所述治疗发生器的远端部分,所述远端部分具有开口,当所述远端部分保持所述治疗发生器时,所述装置的所述细长且柔性的带绝缘导体通过所述开口延伸到所述远端部分之外且大体上向所述远端部分远端延伸;并且所述引导附件包括:
螺旋延伸的壁,所述螺旋延伸的壁形成管腔,所述管腔沿一定长度从其近端开口延伸至其远端开口,所述管腔的直径尺寸设计成在其中并排地容纳所述导丝和所述装置的所述细长且柔性的带绝缘导体,使得所述导丝能在所述管腔内与所述带绝缘导体并排地滑动,并且使得所述壁和所述导体能一起沿所述导丝移动;以及
张力线,所述张力线附接到所述螺旋延伸的壁的近端,所述张力线的长度大于所述植入物导管的长度;并且
其中所述螺旋延伸的壁的相邻匝能彼此分离,使得当所述装置的所述导体在所述管腔内延伸时,在将拉力在近端方向上施加到所述张力线之后,所述壁从所述导体周围退绕。
9.根据权利要求8所述的附件,其特征在于,所述螺旋延伸的壁由螺旋切割的聚合物管形成。
10.根据权利要求8所述的附件,其特征在于,所述螺旋延伸的壁由下列中的一种或组合的螺旋带形成:弹性聚合物和弹性金属。
11.根据权利要求8所述的附件,其特征在于,所述张力线的尺寸设计成在所述导管的另一个管腔内传送。
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US20130035748A1 (en) 2013-02-07
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US8758365B2 (en) 2014-06-24

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