CN101479006A - 在血管内输送和放置闭塞装置的系统和方法 - Google Patents
在血管内输送和放置闭塞装置的系统和方法 Download PDFInfo
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- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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- A—HUMAN NECESSITIES
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- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
Abstract
一种用于放置可用于在血管内通过，例如，颈部重建或球囊重塑来重新塑造动脉瘤的闭塞装置的系统和方法。该系统包括引导鞘(21)和用于携带闭塞装置(29)的组件。组件包括细长柔软元件，其具有用于接合闭塞装置第一末端的闭塞装置(29)锁紧件，邻近位置的用于啮合闭塞装置第二末端的锁紧件，和其上可以放置闭塞装置的围绕细长柔软元件一部分的支撑件。
Description
本申请是2005年5月25日申请的美国申请11/136,395的部分继续申请并对其要求优先权，通过参考其全部在这里明确纳入。
发明领域
本发明大体涉及一种在血管内输送和放置医疗器械的系统和方法，更具体地，其涉及一种在病人的血管系统内输送和放置腔内治疗装置的系统和方法以栓塞和闭塞动脉瘤(aneurysms)，特别是脑动脉瘤(cerebral aneurysms)。
发明背景
血管系统的管壁，特别是动脉管壁，可能形成称为动脉瘤的病理扩张区域。众所周知，动脉瘤具有薄弱的管壁，有破裂趋势。动脉瘤可能是血管管壁被疾病、伤害或先天性畸形削弱的结果。动脉瘤可以在身体的不同部位发现；最常见的是腹部大动脉瘤(abdominal aorticaneurysms)和大脑或脑动脉瘤。当动脉瘤的削弱的壁破裂时，可以导致死亡，尤其如果破裂的是脑动脉瘤时。
动脉瘤通常是通过从动脉循环中去除血管的削弱部分来治疗。对于治疗脑动脉瘤，这样的加强采用很多方式进行：(i)外科手术夹闭，其中金属夹固定在动脉瘤的底部；(ii)用细小柔软金属丝线圈(微线圈)包裹动脉瘤；(iii)用栓塞材料去“填充”动脉瘤；(iv)采用可分离的球囊或线圈去闭塞供给动脉瘤的载瘤血管；和(v)血管内支架成形术。
已知血管内支架在医学领域用于治疗血管狭窄或动脉瘤。支架是假体，在血管或管腔内径向或另外方式展开去提供支持防止血管崩溃。
在将压缩的支架导入血管并放置在狭窄区域或动脉瘤中的常规方法中，具有远端的导引导管经由皮肤导入病人的血管系统中。导引导管在血管内前进直至其远端接近狭窄处或动脉瘤。置于第二内导管管腔内的导丝和内导管前进通过导引导管的远端。然后该导丝从导引导管的远端出去进入血管直到携带压缩支架的导丝的远端部分位于血管内的病变点。一旦压缩支架位于病变处，支架可以释放和展开以便它支持血管。
发明内容
本发明的方面包括在血管内放置闭塞装置的系统和方法。通过，例如，颈部重建或球囊重塑，闭塞装置可用于重新塑造血管内的动脉瘤。闭塞装置可用于形成将闭塞材料如熟知的线圈或粘性流体如Micro therapeutics生产的“ONYX”保留在动脉瘤内的障碍物，以便导入的材料将不会从动脉瘤内漏出。此外，在放置期间，对应闭塞装置和导管内表面之间产生的摩擦，可以调整闭塞装置的长度。当这种情况发生时，闭塞装置的放置长度和圆周大小可以由操作程序的医师根据需要改变。
本发明的一个方面包括支撑和放置闭塞装置的系统。该系统包括引导鞘和用于携带闭塞装置的组件。组件包括具有用于接合闭塞装置第一末端的闭塞装置锁紧件的细长柔软元件、邻近位置的用于啮合闭塞装置第二末端的锁紧件和可以在其上放置闭塞装置的包围细长柔软元件一部分的支撑件。
本发明的另一方面包括支撑和放置闭塞装置的系统。该系统包括用于携带闭塞装置的组件。组件包括具有柔软远端部分的细长元件、用于接合闭塞装置第一末端的锁紧件和用于支撑闭塞装置的包围细长柔软元件一部分的支撑件。
本发明的更进一步的方面包括在血管内导入和放置闭塞装置的方法。该方法包括步骤：将包括携带导丝组件的引导鞘的细长鞘导入导管，和将导丝组件推出鞘从而进入导管。该方法也包括步骤：当将闭塞装置放置在动脉瘤区域期间，将导管末端靠近动脉瘤放置，将导丝组件的一部分推出导管和旋转导丝组件的一部分。
在另一方面，细长柔软元件支撑和放置闭塞装置，基于输入压力，闭塞装置可以展开和收缩。例如，空气或流体的压力可经由柔软元件施加于闭塞装置从而使得闭塞装置展开或收缩。
附图说明
图1是根据本发明的一个方面的闭塞装置输送组件和闭塞装置的横截面。
图2显示图1所示的导管和引导鞘。
图3是携带装载闭塞装置的导丝组件的图2所示的引导鞘的部分剖视图。
图4是图3所示的导丝组件的横截面。
图5是图4的导丝组件的示意图。
图6是图4的导丝组件的第二示意图。
图7显示位于导管外的闭塞装置和导丝组件的一部分，及闭塞装置的近端如何开始放置在血管内。
图8说明在放置闭塞装置的方法中的一个步骤。
图9显示根据本发明的一个方面的闭塞装置的放置。
图10是根据本发明的另一具体实施例的导丝组件的示意图；和
图11是被图10的导丝组件放置后放置的闭塞装置的示意图。
图12说明响应压力而展开的展开的闭塞装置的一个例子。
图13显示在负压力施加于闭塞装置后的图12的闭塞装置。
图14说明闭塞装置远端释放而闭塞装置近端保持附着于输送装置的一个例子。
图5说明部分放置的闭塞装置的一个例子。
图16说明部分放置的闭塞装置的另一个例子。
图17说明图16的例子，其中闭塞装置重新定位在血管内近处。
图18说明展开的闭塞装置的一个例子。
图19说明图18的例子在闭塞装置重新定位在血管内近处后。
图20说明处于收缩状态的闭塞装置的一个例子。
图21说明当闭塞装置收缩时重新定位闭塞装置的一个例子。
发明的详细描述
在此描述了一种闭塞装置输送组件，其具有带细小横截面的部分，且是高度柔软的。图1说明了根据本发明的一个方面的引导鞘10，其接合、包含和输送闭塞装置100至柔软的微导管1用于放置在个体的血管内。闭塞装置100可以包括那些披露在与此有关尚待批准的2005年5月25日申请的名称为“柔软的血管闭塞装置”、美国申请号为11/136,395的美国专利申请中的具体实施例，该美国专利通过参考其全部在这里明确纳入。
引导鞘10的远端12大小和形状设置成可以被接收至微导管1的轮毂2中，如图1和2所示。轮毂2可以置于微导管1的近端或在沿微导管长度方向隔开的另一位置。微导管1可以是任何已知可以导入病人血管并在其中推进的微导管。在一具体实施例中，微导管具有0.047英寸或更小的内径。在另一具体实施例中，微导管具有约0.027英寸至约0.021英寸的内径。在一可选择的具体实施例中，微导管可以具有约0.025英寸的内径。然而，估计微导管1可以具有大于0.047英寸或小于0.021英寸的内径。在引导鞘10置于微导管轮毂2中后，闭塞装置100可以从引导鞘10推进进入微导管1，为将闭塞装置100放置在病人的血管系统内做准备，。
微导管1可以具有至少一流体导入口6，其与轮毂2比邻或在沿着其长度的另一位置。导入口6优选与微导管1的远端液体流通以便在插入血管系统之前流体如生理盐水可以通过微导管1，用于驱赶位于微导管1和微导管1内的任何仪器如导丝中的空气或碎片。如果需要，导入口6也可以用来在血管系统内输送药品或流体。
图3说明了引导鞘10，在引导鞘10中可移动的细长柔软的输送导丝组件20，和闭塞装置100。如图所示，导丝组件20和导丝组件20携带的闭塞装置100尚未导入微导管1。相反，如图说明的，它们是置于引导鞘10内的。引导鞘10可以由各种热塑性塑料制作，如聚四氟乙烯(PTEE)，聚全氟乙丙烯共聚物(FEP)，高密度聚乙烯(HDPE)，聚醚醚酮(PEEK)等，其可以随意排在鞘的内表面或具有亲水性材料如聚乙烯吡咯烷酮(PVP)或其它一些塑料涂层的相邻表面。此外，取决于期望的结果，任一表面可以包被各种材料的不同组合。
引导鞘10可以包括形成在靠近覆盖闭塞装置100的区域的壁中的排水口或或排泄孔(未显示)。可以有单孔或多孔，例如，三孔，形成在引导鞘10中。当在将引导鞘10与导管轮毂2接触放置之前清洗鞘，例如，去消除其中的空气或碎片时，这些排泄孔允许流体，如生理盐水，容易从引导鞘10和导丝组件20之间内漏出。
如图4所示，导丝组件20包括细长柔软的导丝21。当需要用于在血管系统内位置移动闭塞装置100时，导丝21的柔软性允许导丝组件20弯曲和符合血管系统的曲率。导丝21可以由传统导丝材料制成，具有实体横截面。可选择的，导丝21可以由海波管(hypotube)构成。在任一具体实施例中，导丝21具有从约0.010英寸到约0.020英寸的直径D5。在一具体实施例中，导丝21的最大直径是约0.016英寸。用于导丝21的材料可以是任何已知的导丝材料，包括超弹性金属，如镍钛诺(Nitinol)。可选择的，导丝21可以由金属如不锈钢构成。导丝的长度L4可以从约125至约190厘米。在一具体实施例中，长度L4是约175厘米。
导丝组件20可以沿其整个长度具有相同程度的弯曲度。在另一可选择的具体实施例中，导丝组件20可以具有多个纵向部分，每个具有不同程度的弯曲度/刚度。对于导丝组件20，在导丝21的不同纵向部分中使用不同材料和/或厚度可以创建不同程度的弯曲度。在另一具体实施例中，导丝21的弯曲度可以由形成在输送导丝21内的间隔切割(未显示)控制。这些切割可以相互纵向和/或圆周间隔。这些切割可以在输送导丝21中精确形成。输送导丝21的不同部分可以包括不同间距和不同深度形成的切割以提供给这些截然不同的部分不同量的弯曲度和刚度。在上述任一具体实施例中，导丝组件20和导丝21响应由操作者施加于导丝组件20的力矩。如下所讨论的，经由导丝21施加于导丝组件20的力矩可以用于从导丝组件20释放闭塞装置100。
可以控制形成在输送导丝21内的切割的大小和形状以便提供更大或更小量的柔软性。由于切割可以在宽度变化而不改变切割的深度或整体形状，输送导丝21的柔软性可以选择性改变而不影响输送导丝21的抗扭强度。因此，可以选择性地和独立地改变输送导丝21的柔软性和抗扭强度。
有利地，纵向相邻切割对可以围绕输送导丝21的圆周互相旋转约90度以横向地和垂直地提供弯曲。然而，切割可以位于预先确定的位置以在一个或多个期望方向提供优先弯曲。当然，切割可以随机形成以在所有方向或平面允许同样的非优先的弯曲(弯曲度)。在一具体实施例中，这可以通过圆周间隔切割来实现。
柔软的输送导丝21可以包括任何数量的具有相同或不同程度弯曲度的部分。例如，柔软的输送装置21可以包括两个或两个以上的部分。在图4说明的具体实施例中，柔软的输送导丝21包括三个部分，每个具有不同的直径。每一部分可以具有约0.003英寸到约0.025英寸的直径。在一具体实施例中，一个或更多个部分的直径可以约0.010英寸到约0.020英寸。第一部分22包括与闭塞装置100相对的近端23。第一部分22可以沿其长度具有恒定的厚度。可选择的，第一部分22可以具有沿整个长度或仅仅部分长度逐渐变小的厚度(直径)。在逐渐变小的具体实施例中，第一部分22的厚度(直径)在向第二过渡部分24的方向减小。对于那些导丝21具有圆形横截面的具体实施例，厚度是部分的直径。
第二过渡部分24在第一部分22和第三远端部分26之间延伸。第二部分24在厚度上从第一部分22的大直径向第三部分26的较小直径逐渐变小。正如第一部分22，第二部分24可以沿其整个长度或仅仅部分长度逐渐变小。
相对于输送导丝21的其它部分22和24，第三部分26具有一较小的厚度。第三部分26从逐渐变小的携带闭塞装置100的第二部分24延伸出来。第三部分26可以沿其整个长度从第二部分24至输送导丝21的远端27逐渐变小。可选择的，第三部分26可以具有恒定直径或仅沿部分长度逐渐变小。在这样一个具体实施例中，第三部分26的逐渐变小部分可以从第二部分24或与第二部分24间隔开的位置延伸至与输送导丝21的远端27间隔开的位置。虽然对输送导丝21的三个部分进行了讨论和说明，输送导丝21可以包括超过三个部分。此外，这些部分的每一个可以沿全部或仅部分长度在厚度(直径)上逐渐变小。在任何披露的具体实施例中，输送导丝21可以由形状记忆合金如镍钛诺构成。
末端28和柔软的末端线圈29牢固固定于输送导丝21的远端27，如图4和图5所示。如图所示末端28可以包括连续端帽或端盖，其牢固接合末端线圈29的远端。由末端线圈29提供弯曲度控制给输送导丝21的末端部分。然而，在一具体实施例中，末端28可以没有末端线圈29。末端28具有非经皮的(non-percutaneous)、无损伤的(atraumatic)端面。在说明的具体实施例中，末端28具有圆面。在可选择的具体实施例中，末端28可以具有其他非经皮的形状，不会损伤所要导入的血管。如图4所示，末端28包括外壳45，其在外壳45的内表面的开口46内牢固接合导丝21的远端。导丝21可以通过任何已知手段固定在开口中。
如图4所示，末端线圈29围绕导丝21的一部分。末端线圈29是柔软的以便当末端28沿着血管前进和导丝21弯曲以沿着血管系统的路线时，它会符合并沿着病人体内血管的路线。如所示出的，末端线圈29从末端28朝远端23方向向后延伸。
末端28和线圈29具有约0.010英寸到约0.018英寸的外径D1。在一具体实施例中，它们的外径D1约0.014英寸。末端28和线圈29也具有约0.1厘米至约3.0厘米的长度L1。在一具体实施例中，他们具有约1.5厘米的总长度L1。
末端线圈29的近端30接合在保护线圈35的远端24的外壳32内，如图1和4所示。外壳32和保护线圈35具有约0.018英寸到约0.038英寸的外径D2。在一具体实施例中，它们的外径D2约0.024英寸。外壳32和保护线圈35具有约0.05厘米至约0.2厘米的长度L2。在一具体实施例中，它们的总长度L2是约0.15厘米。
外壳32具有非经皮的、无损伤的形状。例如，如图5所示，外壳32具有基本上钝的外形。并且，外壳32大小可以设置成当它通过血管时开放/支持血管。另外，外壳32可以包括成一定角度设置的侧壁，大小设置成恰好间隔引导鞘10的内表面。
外壳32和保护线圈35形成远端锁紧件，其在闭塞装置100输送和放置在血管系统的血管中之前维持闭塞装置100在柔软的导丝组件20上的位置并帮助保持闭塞装置100在压缩状态。保护线圈35从外壳32向输送导丝21的近端23延伸，如图4所示。保护线圈35以任何已知方式固定在外壳32上。在第一具体实施例中，保护线圈35可以固定在外壳32的外表面上。在一可选择的具体实施例中，保护线圈35可固定在外壳32的开口中以便外壳32包围和在内接合保护线圈35(图4)的远端51。如图3和图4所示，闭塞装置100的远端102容纳在近端52中以便当位于鞘10或微导管1中时闭塞装置100不能放置。
在闭塞装置100的近端，缓冲线圈60和盖子62防止闭塞装置100沿着导丝21的长度朝向近端23横向移动，见图3。缓冲线圈60和盖子62具有约0.018英寸到约0.038英寸的外径D4。在一具体实施例中，它们的外径D4约0.024英寸。盖子62接触闭塞装置100的近端107，防止其沿着导丝21的长度移动远离保护线圈35。缓冲线圈60可以以弹簧的形式，其接触和朝保护线圈35的方向压迫盖子62，从而对闭塞装置100形成一个偏置力。这偏置力(压力)帮助维持闭塞装置100的远端102和保护线圈35之间的固定的覆盖的关系。正如沿输送导丝21设置的任何线圈，通过钎焊(soldering)、焊接(welding)，射频焊接(RF welding)，胶水，和/或其他已知的粘合剂，缓冲线圈60可以固定到输送导丝21。
在图10所示的一可选择的具体实施例中，没有使用缓冲线圈60。相反，当位于引导鞘10或微导管1内时，闭塞装置100的近端107通过一套弹簧臂(夹)140保持在位置上。微导管1和引导鞘10的内表面限制臂140径向展开。当闭塞装置的近端伸出微导管1时，臂140将弹开并释放闭塞装置，如图11所示。
在另一例子中，在引导鞘10或微导管1中的闭塞装置100可以在血管内在压力下展开。图12说明了响应压力展开的展开状态的闭塞装置100的一个例子。当闭塞装置100伸出微导管1时，可以通过微导管1或引导鞘10施加压力。压力可以通过应用空气、流体或任何材料施加用于增加闭塞装置的内部压力。当闭塞装置100伸出微导管1时，闭塞装置100内压力的增加可能使得闭塞装置在血管内展开。反之，负压力可以施加在闭塞装置100上。图13说明了负压力施加于闭塞装置100后的图12的闭塞装置100。负压力可以经由微导管1或引导鞘10施加，可能使得闭塞装置100尺寸收缩或减小。在一个例子中，在闭塞装置100伸出微导管1并在血管内展开后，负压力施加在闭塞装置100上。负压力使得闭塞装置100收缩。一旦收缩，闭塞装置100可能在尺寸上收缩。在另一个例子中，收缩后闭塞装置100可以被放回微导管1中。负压力可以通过各种方式施加。例如，负压力可以通过从微导管1中抽吸空气或从微导管1中移除或抽吸流体来施加。
同样，在另一个例子中，例如，通过在闭塞装置内使用增强的压力，可以展开闭塞装置100。增强的压力可以经由输送装置通过，例如，注入空气或流体至闭塞装置100来施加。因此，闭塞装置100可以在血管内展开以便闭塞装置100可接触到血管管壁的内面。这样，在展开状态时，至少闭塞装置100的一部分可以接触血管的管壁。
当在展开状态时，闭塞装置100可以置于血管内。图18说明了展开状态的闭塞装置100的一个例子。图19说明了图18的例子在闭塞装置在血管内重新定位后。在这个例子中，闭塞装置100可以沿着血管朝纵轴反向展开，以便闭塞装置100在展开时可以在血管内移动。压力可以由使用者施加在闭塞装置100的近端以便近端在血管管腔内移向远处。与此同时，在血管的管壁和闭塞装置更远端部分的摩擦力可以防止闭塞装置更远端部分的立即移动。当施加在近端的压力或力量超过一阈值水平，力量将传送到闭塞装置更远端部分从而导致闭塞装置的更远端部分在血管管腔内移向远处。通过这种方式，闭塞装置可以在血管管腔中移向远处，可以被使用者重新置于血管内的期望位置。图19说明在血管中的闭塞装置的远处重新定位。
同样的，闭塞装置可以被使用者更近地重新定位在血管管腔中。例如，使用者可以在闭塞装置远端部分朝近端方向提供力量或压力。闭塞装置的远端部分可能朝近端移动而在闭塞装置更近端部分的摩擦力阻止闭塞装置更近端部分的初始运动。因此，在这个例子中，闭塞装置在闭塞装置的远端部分和更近端部分之间的中间部分压缩。当由使用者在闭塞装置的远端部分施加的压力或力量超过一阈值水平，其超过阻止闭塞装置更近端部分运动的摩擦力，响应施加的压力或力量，闭塞装置更近端部分可以朝近端方向移动。通过这种方式，闭塞装置可以在血管内向近处重新定位。
在另一个例子中，闭塞装置100可以置于血管内而闭塞装置100处于收缩状态。图20说明了处于收缩状态的闭塞装置100的一个例子。举例来说，负压力可以施加在图12的闭塞装置100以使闭塞装置100尺寸减小，如图20所示。如图20所示的闭塞装置100被收缩，接近输送装置。图21表明当闭塞装置被收缩时重新定位闭塞装置100的一个例子。如图21所示，闭塞装置朝远处方向移动。同样的，闭塞装置也可以朝近处方向重新定位(未显示)。
此外，闭塞装置的放置可分部分进行。例如，闭塞装置100可以具有远端和近端。闭塞装置的放置可以包括释放远端随后释放闭塞装置的近端。可选择的，闭塞装置的放置可以包括释放近端随后释放远端。并且，闭塞装置的放置可以包括基本上在同一时间释放闭塞装置100的近端和远端。
图14说明闭塞装置100远端释放而闭塞装置的近端保持连接在输送装置上的一个例子。如图14所示，闭塞装置100的远端放置且毗邻血管管壁。闭塞装置100的近端仍然附着在输送装置上。闭塞装置近端的释放可以以在此处所述的各种方式实现。
此外，如图14所示的部分放置的闭塞装置100可以在血管中重新定位。图15说明部分放置的闭塞装置100的一个例子，其中闭塞装置100的远端已经从输送装置释放而闭塞装置100的近端未放置而保持连接到输送装置。此外，图15证明当部分放置时闭塞装置的重新定位。如图15所示，输送装置和闭塞装置100已经在血管内移至近处。同样，图15说明闭塞装置部分放置在血管内以便闭塞装置的远端从输送装置释放而闭塞装置100的近端保持连接至输送装置。
可选择的，闭塞装置的近端可以从输送装置释放而闭塞装置的远端保持连接到输送装置。闭塞装置的远端可以随后从输送装置释放出来或放置出来。图16说明在血管中部分放置的闭塞装置100的一个例子，其中闭塞装置100的近端从输送装置释放而闭塞装置100的远端保持连接至输送装置。从而，闭塞装置100的近端接近血管管壁。
图17说明了图16的例子，其中闭塞装置100重新定位在血管的近处。在这个例子中，闭塞装置部分放置以便闭塞装置100的近端从输送装置释放而闭塞装置100的远端是连接的。然后，闭塞装置在血管中移动或重新定位至更近位置。可选择的，闭塞装置也可在血管中移动或重新定位至更远位置(未示出)。
在一可选择的具体实施例中，缓冲线圈60和盖子62可以去掉，通过导丝21的锥形部分，闭塞装置100的近端可以保持在相对保护线圈35的位置。在这样一个具体实施例中，该锥形部分的扩大的横截面可以用于沿输送导丝21的长度方向保持闭塞装置100在位置上，并防止闭塞装置100朝近端23的方向移动。
如图4所示，导丝组件20包括用于闭塞装置100的支撑件70。在第一具体实施例中，支撑件70可以包括输送导丝21的外表面，其大小设置成当闭塞装置100装在导丝组件20上时接触闭塞装置100的内表面。在该具体实施例中，输送导丝21的外表面支撑闭塞装置100并保持它在准备放置状态。在另一具体实施例中，如图所示，支撑件70包括中间线圈70，其从接近保护线圈35的位置向后朝向缓冲线圈60延伸。中间线圈70在闭塞装置100下、输送导丝21上延伸，如图1所示。中间线圈70可以与输送导丝21的一个过多个部分共存。例如，中间线圈70可以仅和输送导丝21的第二部分24共存，或它可以沿输送导丝21的第三部分26和第二部分24的部分延伸。
中间线圈70提供给导丝组件20朝外延伸的表面，其大小设置成接触闭塞装置100的内表面以协助支撑闭塞装置和保持闭塞装置100在准备放置状态。像这里讨论的和附图说明的其他线圈，当输送导丝21前进通过病人的血管系统时，中间线圈70的螺旋形式允许中间线圈70随输送导丝21弯曲。不管闭塞装置100下的输送导丝21的逐渐变细，中间线圈70沿闭塞装置100覆盖的输送导丝21的一段长度提供固定直径。中间线圈70允许输送导丝21逐渐变细从而可以实现所需的柔软性去跟随血管系统的路径而不危及提供给闭塞装置100的支撑。在闭塞装置100放置之前，中间线圈70提供给闭塞装置100持续支撑而不管输送导丝21的逐渐变细。当处于压缩状态时，闭塞装置100的最小直径也是由中间线圈70的尺寸控制。此外，可以选择中间线圈70的直径以便在闭塞装置100和微导管1的内壁之间形成合适的间距，包括没有间距。在闭塞装置100放置期间，中间线圈70还可以用来偏置闭塞装置100远离输送导丝21。
在任一具体实施例中，支撑件70可以具有约0.010英寸到约0.018英寸的外径D3。在一个具体实施例中，外径D3约0.014英寸。支撑件70也可以具有约2.0厘米至约30厘米的长度L3。在一个具体实施例中，支撑件70的长度L3约7厘米。
闭塞装置100也可以放在中间线圈70上位于一组可选的位于沿导丝组件20长度方向上的不透射线标记区带(radio-paque maker bands)之间。可选择的，保护线圈35、缓冲线圈60或中间线圈70可以包括不透射线标记(radio-opaque markers)。在一可选择的具体实施例中，导丝组件20可以只包括一单一不透射线标记。不透射线标记的使用允许在血管内放置期间导丝组件20和闭塞装置100的可视化。这种可视化技术可以包括常规的方法，如荧光透视法(fluoroscopy)、X光线照相术(radiography)、超声波扫描术(ultra-sonography)，磁共振成像(magnetic resonance imaging)等。
按照下列方法和它的变化方法，闭塞装置100可以输送和放置在动脉瘤位置。闭塞装置100的输送包括将微导管1导入血管中直至其到达需要治疗的位置。使用常规技术，如在常规血管导丝(未显示)上推进或与其同时推进，将微导管1导入血管中。微导管1的定位可以发生在它接合导丝组件20之前或当它含有导丝组件20时。微导管1在血管系统内的位置可通过识别位于微导管1上或在微导管1中的不透射线标记来确定。
在微导管1置于期望位置后，移除导丝，引导鞘10的远端插入微导管1的近端，如图1所示。在一个具体实施例中，引导鞘10的远端通过微导管1近端的轮毂2导入。引导鞘10在微导管1中前进直到引导鞘10的远端楔入微导管1中。在这一位置，引导鞘10不能在微导管1内进一步前进。然后引导鞘10牢固保持而携带闭塞装置100的输送导丝组件20前进通过引导鞘10，直至闭塞装置100推出引导鞘10进入微导管1中。
导丝组装20和闭塞装置100前进通过微导管1直至末端线圈29接近微导管1的远端。在这一时刻，可以确认微导管1和导丝组件20的位置。然后，导丝组件20前进穿出微导管1并进入病人的血管系统中，以便闭塞装置100的近端107位于微导管1的远端外并邻近要治疗的区域。在这些步骤的任何时候，可以检查闭塞装置100的位置以确定它将被正确放置及位于期望的位置。这可以通过使用上面讨论的不透射线标记来实现。
当闭塞装置100的远端102位于微导管1外时，近端107将开始在血管系统内朝图7所示的箭头方向展开，而远端102保持被保护线圈35覆盖。当闭塞装置100在合适位置时，输送导丝21旋转(见图8)，直到闭塞装置100的远端102离开保护线圈35，并在血管内在期望位置展开。输送导线21可以根据需要顺时针或逆时针旋转去放置闭塞装置100。在一个具体实施例中，输送导丝21可以例如在任一或两个方向旋转2～10圈。在另一个例子中，闭塞装置可以通过顺时针旋转输送导丝21不到5圈，例如，3～5圈来放置。在闭塞装置100放置后，输送导丝21可以收进微导管100中并移出体外。
在一个可选择的或另外的放置方法中，闭塞装置100的远端102可以穿出微导管1外。闭塞装置100可以进一步前进以便闭塞装置100的近端107穿出微导管外。然而，在这个例子中，闭塞装置100的近端107响应对闭塞装置100的内表面压力的施加而展开。施加在闭塞装置100内的压力的例子包括，但不限于，注入流体或空气进入闭塞装置的管腔。
闭塞装置100中压力的增加可以导致闭塞装置100展开。闭塞装置100的展开可以导致闭塞装置100的近端107和/或闭塞装置100的远端分离从而闭塞装置可以基本填充血管的管腔。可选择的，闭塞装置100中压力的增加可以展开闭塞装置100而不分离闭塞装置100的近端107或远端102。在这个例子中，闭塞装置100可以展开而不将闭塞装置100从输送系统分离。当连接至输送系统时，可以在血管内以展开状态调整和移动展开的闭塞装置100。当闭塞装置100在血管内位于期望位置时，闭塞装置100可以从输送系统释放。闭塞装置100的释放可以以这里描述的多种方式来完成。
另外，当闭塞装置展开并连接在输送系统时，可以调整闭塞装置100的覆盖度。例如，闭塞装置100可以从微导管1穿出并在压力(例如，来自流体或空气)下展开以便闭塞装置100在血管内展开。闭塞装置100的位置可以进一步调整。并且，可以调整施加在闭塞装置100内的压力以增加在血管内的展开的闭塞装置100尺寸。当置于血管内时，相对调整展开的闭塞装置100的尺寸(即，通过调整施加到闭塞装置100的压力大小)和闭塞装置100的位置或方位允许控制闭塞装置的覆盖度。
同样，可以施加负压力(例如，从闭塞装置100抽吸空气或移除流体)以使闭塞装置收缩。收缩的闭塞装置100可以进一步放置回微导管1中。在一个例子中，闭塞装置100可以根据需要展开和收缩，用于在血管内移动或放置闭塞装置。
在如图9所示的一可选择的或另外的放置步骤中，闭塞装置100和微导管1的内表面之间的摩擦使得闭塞装置100的远端分离保护线圈35。摩擦可以通过闭塞装置100的打开和/或中间线圈70偏置闭塞装置100朝向微导管1的内表面而产生。微导管1和阻断装置100之间的摩擦将协助闭塞装置100的放置。在当闭塞装置100在放置过程中没有打开和分离保护线圈35的那些例子中，随着输送导丝21和微导管1相对移动，闭塞装置100和微导管1的内表面之间的摩擦将使闭塞装置100离开保护线圈35。输送导丝21然后可以旋转，闭塞装置100在血管内放置。
在闭塞装置100径向自我展开至温和但牢固接触血管的管壁以便闭塞动脉瘤A的颈部后，微导管1可以整个移出病人的身体。可选择的，微导管1可以留在血管系统内适当位置以允许在治疗点附近插入其它工具或使用药物。
已知的材料可以用于本发明。一种常见的可以用于闭塞装置100和导丝21的材料是镍钛诺，一种镍钛形状记忆合金，其可以成形和退火，在低温变形，在加热例如在体内处于体温时回复至原来形状。不透射线标记可以用不透射线材料包括金属，如铂金，或包括铋或钨的掺杂塑料构成，以协助可视化。
这里讨论的仪器和方法并不仅限于在血管系统内的放置和使用，还可包括许多另外的治疗应用。其他治疗位点可以包括身体的区域或范围，如器官机体。对本领域技术人员来说明显的用于实现发明的上述装置和方法的调整和本发明方面的改变将落在权利要求的范围内。此外，不管元件、组件或方法步骤是否在权利要求中明确列举，元件、组件或方法步骤均不是用来献给公众的。
Claims (19)
1.一种用于支撑和放置闭塞装置的细长柔软元件，所述元件接合闭塞装置的第一末端和啮合闭塞装置的第二末端，并包括用于啮合所述闭塞装置的内表面的外表面，其中闭塞装置基于输入压力能够展开和收缩。
2.根据权利要求1所述的元件，其特征在于，进一步包括用于携带闭塞装置的引导鞘，闭塞装置位于引导鞘远端。
3.根据权利要求2所述的元件，其特征在于，闭塞装置是通过经由细长柔软元件施加的空气压力而展开的。
4.根据权利要求3所述的元件，其特征在于，闭塞装置的远端的放置响应第二使用者输入。
5.根据权利要求3所述的元件，其特征在于，闭塞装置在血管内是处于展开状态的，并在展开状态在血管内重新定位。
6.根据权利要求5所述的元件，其特征在于，闭塞装置在血管内响应闭塞装置近端受到的压力朝向远处方向重新定位。
7.根据权利要求6所述的元件，其特征在于，闭塞装置近端受到的压力超过闭塞装置和血管之间的摩擦力。
8.根据权利要求1所述的元件，其特征在于，闭塞装置是通过经由细长柔软元件施加的液体压力而展开的。
9.根据权利要求1所述的元件，其特征在于，闭塞装置包括在网格结构中的许多螺旋缠绕材料，网格结构具有可调节的网格密度，网格密度可以响应第二使用者输入而调节。
10.根据权利要求9所述的元件，其特征在于，第二使用者输入施加在元件的近端。
11.根据权利要求1所述的元件，其特征在于，闭塞装置能够展开以创建一通道。
12.根据权利要求5所述的元件，其特征在于，进一步包括引导鞘和带有柔软无损伤末端的导丝。
13.根据权利要求5所述的元件，其特征在于，进一步包括沿元件的一部分延伸并具有用于啮合闭塞装置内表面的外表面的支撑件，进一步包括邻近设置的锁紧件，其包括当闭塞装置放置在支撑件上时促使闭塞装置朝向元件远端的偏置件。
14.根据权利要求5所述的元件，其特征在于，进一步包括用于啮合闭塞装置第二末端的邻近设置的锁紧件，其中邻近设置的锁紧件包括元件的一部分。
15.根据权利要求5所述的元件，其特征在于，进一步包括用于接合闭塞装置第一末端的闭塞装置锁紧件，闭塞装置锁紧件包括用于接合闭塞装置第一末端的内部开口。
16.根据权利要求5所述的元件，其特征在于，进一步包括用于接合闭塞装置第一末端的闭塞装置锁紧件，闭塞装置锁紧件包括螺旋弹簧。
17.根据权利要求5所述的元件，其特征在于，进一步包括沿元件的一部分延伸的支撑件和用于接合闭塞装置第一末端的闭塞装置锁紧件，闭塞装置锁紧件具有从元件外表面比支撑件外表面延伸更长的外表面。
18.根据权利要求5所述的元件，其特征在于，进一步包括用于携带闭塞装置的引导鞘和相对于引导鞘和闭塞装置可旋转的柔软导丝。
19.根据权利要求5所述的元件，其特征在于，进一步包括元件和闭塞装置可以置于其中的导管。
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| Publication number | Publication date |
|---|---|
| CA2651991A1 (en) | 2007-12-06 |
| US20060271153A1 (en) | 2006-11-30 |
| WO2007139698A2 (en) | 2007-12-06 |
| US8267985B2 (en) | 2012-09-18 |
| US10322018B2 (en) | 2019-06-18 |
| US9204983B2 (en) | 2015-12-08 |
| WO2007139698A3 (en) | 2008-11-06 |
| EP2019704A4 (en) | 2012-07-11 |
| AU2007268143A1 (en) | 2007-12-06 |
| US20130172976A1 (en) | 2013-07-04 |
| EP2019704A2 (en) | 2009-02-04 |
| US20160151184A1 (en) | 2016-06-02 |
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