CN101180006B - 用于在血管内输送和展开封堵器的系统 - Google Patents

用于在血管内输送和展开封堵器的系统 Download PDF

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CN101180006B
CN101180006B CN2005800498707A CN200580049870A CN101180006B CN 101180006 B CN101180006 B CN 101180006B CN 2005800498707 A CN2005800498707 A CN 2005800498707A CN 200580049870 A CN200580049870 A CN 200580049870A CN 101180006 B CN101180006 B CN 101180006B
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stopper
retaining member
seal wire
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assembly
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亚伦·李·贝瑞兹
夸恩·库欧克·特兰
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Ev3 Co
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Covidien LP
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A61B17/12118—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm for positioning in conjunction with a stent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2/9662—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod the middle portion of the stent or stent-graft is released first
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • 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
    • 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/823—Stents, different from stent-grafts, adapted to cover an aneurysm
    • 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
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • A61F2002/9665—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod with additional retaining means

Abstract

一种用于展开封堵器的系统和方法，可用来通过例如颈部重建或球囊重造来重造血管内的动脉瘤。所述系统包括导引鞘和用于携带封堵器的组件。所述组件包括细长形柔性构件，所述细长形柔性构件具有封堵器保持构件、近端设置的保持构件，以及支撑物，其中所述封堵器保持构件用于容纳封堵器的第一端，所述近端设置的保持构件用于啮合封堵器的第二端，所述支撑物包围细长形柔性构件的一部分，封堵器可定位在支撑物上。

Description

用于在血管内输送和展开封堵器的系统
技术领域
本发明通常涉及一种用于在血管内输送和展开医疗器械的系统和方法，更特别地，本发明涉及一种用于在患者的脉管系统内输送和展开腔内治疗器械以栓塞和封堵动脉瘤尤其是脑动脉瘤的系统和方法。
背景技术
脉管系统的壁，尤其是动脉壁可能会形成称为动脉瘤的病理性扩张区域。众所周知，动脉瘤具有易于破裂的薄弱壁。动脉瘤可能是血管壁受到疾病、伤害或先天异常削弱的结果。动脉瘤可存在于人体内的不同部位，最常见的是腹主动脉瘤(abdominal aortic aneurysm)和神经脉管系统内的脑动脉瘤(brain or cerebral aneurysm)。当动脉瘤的被削弱的壁破裂时，会导致死亡，尤其是如果是脑动脉瘤破裂。
通常通过把血管的削弱部分排除在动脉循环外来治疗动脉瘤。对于治疗脑动脉瘤来说，这种补强可以多种方式进行，包括：(i)手术夹闭(surgical clipping)，围绕动脉瘤基底固定金属夹子；(ii)用小的、柔性的线盘(微螺圈)(micro-coil)填满动脉瘤；(iii)用栓塞材料“填充”动脉瘤；(iv)用可脱性球囊(detachable balloon)或螺圈封堵为动脉瘤供血的母血管；以及(v)血管内支架植入术(intravascular stenting)。
医术上用于治疗脉管狭窄(vascular stenose)或动脉瘤的血管内支架是众所周知的。支架是在血管或管腔内径向扩张或以其它方式提供支撑以免血管萎缩的修补物(prostheses)。用于输送这些血管内支架的方法也是众所周知的。
在将压缩支架引入血管并将其定位在狭窄区域内或动脉瘤内的传统方法中，将具有远端顶部(distal tip)的指引导管(guiding catheter)经由皮肤引入患者的脉管系统。在血管内推进指引导管直到其远端顶部接近狭窄或动脉瘤。穿过指引导管的远端推进设置在第二、内部导管的内部管腔内的导丝(guidewire)和内部导管。然后，将导丝推出指引导管的远端进入血管，直到携带压缩支架的导丝的远端部分定位在血管内的病变点。一旦压缩支架位于病变处，就可以释放和扩张支架以便其支撑血管。
发明内容
本发明的各方面包括一种在血管内展开封堵器(occluding device)的系统和方法。封堵器能用来重造血管内的动脉瘤，例如，通过颈部再造或球囊重造。封堵器能用来形成将封堵材料保持在动脉瘤内的屏障(barrier)，以便所引入的材料不从动脉瘤内逸出，其中所述封堵材料例如众所周知的螺圈或粘性流体，例如Microtherapeutics公司的“新型血管内液体栓塞剂”(“ONYX”)。在展开期间，也可响应于在封堵器和导管内表面之间所产生的摩擦来调节封堵器的长度。当这种情况出现时，可根据需要由进行手术的医生来改变封堵器的展开长度和周围尺寸。
本发明的一方面包括一种用于支撑和展开封堵器的系统。该系统包括导引鞘(introducer sheath)和用于携带封堵器的组件。所述组件包括细长形柔性构件，所述柔性构件具有封堵器保持构件(occluding device retainingmember)、近端设置的保持构件(proximally positioned retaining member)，以及支撑物(support)，其中所述封堵器保持构件用于容纳封堵器的第一端，所述近端设置的保持构件用于啮合封堵器的第二端，所述支撑物包围细长形柔性构件的一部分，封堵器可定位在该支撑物上。
本发明的另一方面包括一种用于支撑和展开封堵器的系统。该系统包括用于携带封堵器的组件。所述组件包括细长形构件，所述细长形构件包括柔性远端顶部部分、保持构件以及支撑物，其中所述保持构件用于容纳封堵器的第一端，所述支撑物包围细长形柔性构件的一部分以用于支撑封堵器。
本发明的进一步的方面包括一种在血管内引入和展开封堵器的方法。此方法包括步骤：将包括携带导丝组件的导引鞘的细长形鞘引入导管，并将导丝组件推出鞘进入导管。该方法还包括步骤：将导管端部定位成接近动脉瘤，将导丝组件的一部分推出导管，并旋转导丝组件的一部分，同时在动脉瘤区域展开封堵器。
附图说明
图1是根据本发明的一方面的封堵器输送组件和封堵器的横截面；
图2展示了图1所显示的导管和导引鞘；
图3是图2导引鞘的部分切掉视图，携带了装有封堵器的导丝组件；
图4是图3所展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展示了封堵器和设置在导管外面的导丝组件的一部分，还展示了封堵器的近端如何在脉管内开始展开；
图8展示了展开封堵器方法的步骤；
图9展示了根据本发明一方面的封堵器的展开；
图10是根据本发明另一实施方案的导丝组件的示意图；以及
图11是在已经由图10导丝组件展开之后的展开的封堵器的示意图。
发明详细描述
此处描述了具有小横截面部分的封堵器输送组件，其是高柔性的。图1展示了根据本发明的一方面的导引鞘10，该导引鞘10容纳和装载封堵器100，并将封堵器100输送到柔性微导管1以用于定位在个人的脉管系统内。封堵器100可包括2005年5月25日提交的题为“柔性脉管封堵器”(“Flexible Vascular Occluding Device”)的共同待决的U.S.专利申请(Atty.DocketNo.006258.00010)中所公开的那些实施方案，此专利的全部内容在此特别引入作为参考。
导引鞘10的远端12的尺寸和外形形成为可容纳在微导管1的插孔(hub)2内，如图1和2所显示的。插孔2可设置在微导管1的近端或设置在沿着微导管1的长度间隔开的另一位置。微导管1可以是能穿过患者的脉管系统引入并推进的任何已知的微导管。在实施方案中，微导管具有0.047英寸的内径或更小的内径。在另一实施方案中，微导管具有约0.027英寸至约0.021英寸的内径。在备选实施方案中，微导管可具有约0.025英寸的内径。然而，可以预期的是，导管1可具有大于0.047英寸或小于0.021英寸的内径。在将导引鞘10定位在导管插孔2内之后，可以将封堵器100从导引鞘10推入微导管1，以准备在患者的脉管系统内展开封堵器100。
微导管1可具有位于邻近插孔2或位于沿其长度的另一位置的至少一个流体引入口(fluid introduction port)6。口6优选地与微导管1的远端流体连通，以便例如盐水等的流体可在微导管1插入脉管系统之前穿过微导管1以用于冲走微导管1内和例如设置在微导管1内的导丝等任何器具内的空气或碎片。口6还可以根据需要用于在脉管系统内输送药物或流体。
图3展示了导引鞘10、可在导引鞘10内移动的细长形柔性输送导丝组件20以及封堵器100。如所显示的，导丝组件20和由导丝组件20携带的封堵器100还未引入微导管1。而是，如所展示的，导丝组件20和由导丝组件20携带的封堵器100仍位于导引鞘10内。导引鞘10可由各种热塑性材料制成，例如PTFE、FEP、HDPE、PEEK等，这些材料可任选地用亲水材料例如PVP或一些其它塑性涂料嵌入在鞘的内表面上或邻近表面上。此外，根据所期望的结果，任一表面都可涂有各种不同材料的组合。
导引鞘10可包括排泄口(drainage port)或净化孔(purge hole)(未显示)，这些排泄口或净化孔被形成到覆盖封堵器100的区域附近的壁中。可存在有单个或多个，例如三个形成到导引鞘10中的孔。这些净化孔使诸如盐水等的流体能当在定位导引鞘10与导管插孔2接触之前净化鞘例如以去除滞留空气或碎片时容易地从导引鞘10和导丝组件20之间逸出。
如图4所显示的，导丝组件20包括细长形柔性导丝21。导丝21的柔性允许导丝组件20根据封堵器100在脉管系统内的位置移动要求来弯曲以与脉管系统的曲率一致。导丝21可由传统的导丝材料制成且可具有实心的横截面。可供选择地，导丝21可由海波管(hypotube)形成。在每一个实施方案中，导丝21具有约0.010英寸至约0.020英寸范围的直径D5。在实施方案中，导丝21的最大直径约0.016英寸。用于导丝21的材料可以是任何已知的导丝材料，包括超塑性金属，例如镍钛诺。可供选择地，导丝21可由诸如不锈钢的金属形成。导丝的长度L4可以是约125cm至约190cm。在实施方案中，长度L4约175cm。
导丝组件20可沿其整个长度具有同样程度的曲率。在备选实施方案中，导丝组件20可具有带有不同程度曲率/刚性的纵向区段。导丝组件20的不同程度的曲率可通过在导丝21的不同纵向区段内使用不同的材料和/或厚度来形成。在另一实施方案中，导丝21的曲率可由在输送导丝21内形成的间隔的切口(cut)(未显示)来控制。这些切口可以纵向和/或周向互相隔开。切口可精确地形成在输送导丝21内。输送导丝21的不同区段可包括以不同间距和不同深度形成的切口以给这些不同的区段提供不同量的曲率和刚性。在以上的任何实施方案中，导丝组件20和导丝21对由操作者施加到导丝组件20的扭矩敏感。如以下所描述的，通过导丝21施加到导丝组件20的扭矩可用来从导丝组件20释放封堵器100。
可控制在输送导丝21内形成的切口的尺寸和形状以便提供或多或少量的柔性。因为切口可在宽度范围内改变而并不改变切口的深度或总体形状，所以可以选择性地改变输送导丝21的柔性而并不影响输送导丝21的扭转强度。这样，就可选择性地且独立地改变输送导丝21的柔性和扭转强度。
有利地，纵向邻近的切口对可围绕输送导丝21的周围互相旋转约90度以横向地和垂直地提供扭曲。然而，切口还可位于预定的位置以提供一个或多个希望方向的择优的扭曲。当然，切口还可任意地形成以允许非优选地在所有方向或平面中同等地弯曲(曲率)。在一个实施方案中，这可以通过周向间隔的切口来实现。
柔性输送导丝21可包括具有相同程度或不同程度曲率的任何数量的区段。例如，柔性输送导丝21可包括两个或更多个区段。在图4所展示的实施方案中，柔性输送导丝21包括三个具有不同直径的区段。每个区段可具有约0.005英寸至约0.025英寸的直径。在实施方案中，一个或更多个区段的直径可以是约0.010英寸到约0.020英寸。第一区段22包括位于封堵器100相反位置的近端23。第一区段22可沿其长度具有固定的厚度。可供选择地，第一区段22可具有沿其整个长度或其长度的仅仅一部分的渐缩的厚度(直径)。在渐缩的实施方案中，第一区段22的厚度(直径)在第二、过渡区段24的方向减小。对于导丝21具有圆形横截面的那些实施方案来说，厚度是区段的直径。
第二、过渡区段24在第一区段22和第三、远端区段26之间延伸。第二区段24在厚度上从第一区段22的大直径渐缩到第三区段26的较小直径。与第一区段22一样，第二区段24可沿其整个长度或其长度的仅仅一部分渐缩。
与输送导丝21的其他区段22、24相比，第三区段26具有较小的厚度。第三区段26延伸离开携带封堵器100的渐缩的第二区段24。第三区段26可沿其整个长度从第二区段24渐缩到输送导丝21的远端27。可供选择地，第三区段26可具有固定的直径或仅沿其长度的一部分渐缩。在这样的实施方案中，第三区段26的渐缩部分可从第二区段24或从与第二区段24隔开的位置点延伸到与输送导丝21的远端27隔开的位置点。尽管描述和展示了输送导丝21的三个区段，但是输送导丝21可以包括多于三个的区段。此外，这些区段中的每一个都可以沿其整个长度或仅沿其长度的一部分在其厚度(直径)上渐缩。在所公开的任何实施方案中，输送导丝21可以由形状记忆合金如镍钛诺形成。
顶部28和柔性顶部螺圈29被固定到输送导丝21的远端27，如图4和5所显示的。顶部28可包括连续的端帽或端盖，如图形中所显示的，所述端帽或端盖稳固地容纳顶部螺圈29的远端。顶部螺圈29为输送导丝21的远端部分提供曲率控制。然而，在实施方案中，顶部28可以没有螺圈29。顶部28具有不经皮肤的、防止损伤的端面。在所展示的实施方案中，顶部28具有圆形面。在备选的实施方案中，顶部28可具有其他不经皮肤的形状，这种形状不会伤害其所导入的血管。如图4所展示的，顶部28包括外壳(housing)45，所述外壳45稳固地将导丝21的远端容纳在外壳45的内表面中的开口46内。可由任何已知手段将导丝21固定在开口内。
如图4所示的，顶部螺圈29包围导丝21的一部分。顶部螺圈29是柔性的，以便当顶部28沿血管推进时，顶部螺圈29与患者体内的血管路径一致并沿患者体内的血管路径而行，并且导丝21弯曲以沿脉管系统的曲折路径而行。顶部螺圈29在近端23的方向从顶部28向后延伸，如所显示的。
顶部28和螺圈29具有约0.010英寸至约0.018英寸的外径D1。在实施方案中，顶部28和螺圈29的外径D1约0.014英寸。顶部28和螺圈29还具有约0.1cm至约3.0cm的长度L1。在实施方案中，他们具有约1.5cm的总长度L1。
在保护螺圈(protective coil)35的远端24处，顶部螺圈29的近端30容纳在外壳32内，如图1和图4所显示的。外壳32和保护螺圈35具有约0.018英寸至约0.038英寸的外径D2。在实施方案中，外壳32和保护螺圈35的外径D2约0.024英寸。外壳32和保护螺圈35具有约0.05cm至约0.2cm的长度L2。在实施方案中，他们的总长度L2约0.15cm。
外壳32具有不经皮肤的、防止损伤的形状。例如，如图5所显示的，外壳32具有实质上圆头外形(blunt profile)。而且，外壳32的尺寸可形成为当其穿过血管时能打开/支撑血管。此外，外壳32可包括倾斜的侧壁，该侧壁的尺寸形成为刚好隔开导引鞘10的内表面。
外壳32和保护螺圈35形成远端保持构件(retaining member)，在脉管系统的血管内输送和展开封堵器100之前，该保持构件维持封堵器100在柔性导丝组件20上的位置并帮助保持封堵器100处于压缩状态。保护螺圈35在输送导丝21的近端23的方向从外壳32延伸，如图4所显示的。保护螺圈35以任何已知的方式固定到外壳32。在第一实施方案中，保护螺圈35可固定到外壳32的外表面。在备选实施方案中，保护螺圈35可固定在外壳32的开口内以便外壳32包围和内部地容纳保护螺圈35的远端51(图4)。如图3和4所显示的，封堵器100的远端102保持在近端52内以便封堵器100在定位在鞘10或微导管1内时不展开。
在封堵器100的近端，缓冲螺圈(bumper coil)60和帽62防止封堵器100在近端23的方向沿导丝21的长度侧向移动，见图3。缓冲螺圈60和帽62具有约0.018英寸至0.038英寸的外径D4。在实施方案中，缓冲螺圈60和帽62的外径D4约0.024英寸。帽62接触封堵器100的近端107并防止封堵器100沿导丝21的长度移动离开保护螺圈35。缓冲螺圈60可以是弹簧形式，其在保护螺圈35的方向接触并压缩帽62，从而产生抵抗封堵器100的偏置力。这种偏置力(压力)有助于维持封堵器100的远端102和保护螺圈35之间的固定、覆盖关系。与沿输送导丝21设置的任何螺圈一样，缓冲螺圈60可通过钎焊、焊接、射频焊接、胶合和/或其他已知的粘合剂固定到输送导丝21。
在图10所展示的备选实施方案中，没有使用缓冲螺圈60。代替地，当封堵器100被定位在导引鞘10或微导管1内时，封堵器100的近端107由一组弹簧加载的臂(卡爪)140保持在适当的位置。微导管1的内表面和导引鞘10限制臂140的径向膨胀。当封堵器的近端穿出微导管1时，臂140将弹开并释放封堵器，如图11所显示的。
在备选实施方案中，可以没有缓冲螺圈60和帽62而通过导丝21的渐缩区段将封堵器100的近端保持在相对于保护螺圈35的适当位置。在这样的实施方案中，这个渐缩区段的大横截面可用来沿输送导丝21的长度将封堵器100保持在适当位置且可用来防止封堵器100在近端23的方向移动。
如图4所显示的，导丝组件20包括用于封堵器100的支撑物70。在第一实施方案中，支撑物70可包括输送导丝21的外表面，输送导丝21的外表面的尺寸形成为当封堵器100装在导丝组件20上时该外表面接触封堵器100的内表面。在此实施方案中，输送导丝21的外表面支撑封堵器100并将其维持在准备展开的状态。在另一实施方案中，如图形所展示的，支撑物70包括中间螺圈(mid-coil)70，其从接近保护螺圈35的位置向后朝着缓冲螺圈60延伸。中间螺圈70在封堵器100之下、输送导丝21之上延伸，如图1所显示的。中间螺圈70可与输送导丝21的一个或更多个区段共同延伸。例如，中间螺圈70可只与输送导丝21的第二区段24共同延伸，或者中间螺圈70可既沿着输送导丝21的第三区段26又沿着输送导丝21的第二区段24的部分延伸。
中间螺圈70为导丝组件20提供向外延伸的表面，该延伸的表面的尺寸形成为接触封堵器100的内表面以便帮助支撑封堵器并且将封堵器100维持在准备展开的状态。如此处所描述的和图形中所展示的其他螺圈一样，中间螺圈70的绕线形式允许当输送导丝21穿过患者的脉管系统推进时，中间螺圈70与输送导丝21一起弯曲。中间螺圈70提供沿输送导丝21的由封堵器100覆盖的长度的固定直径，而与封堵器100下面的输送导丝21的锥度无关。中间螺圈70允许输送导丝21渐缩，这样其可以实现所需要的柔性以沿脉管系统的路径而行，而并不会损害提供给封堵器100的支撑。在封堵器100展开之前，中间螺圈70给封堵器100提供恒定的支撑而与输送导丝21的锥度无关。封堵器100在压缩状态时的最小直径也由中间螺圈70的尺寸来控制。此外，可选择中间螺圈70的直径以便在封堵器100展开之前，在封堵器100和微导管1的内壁之间建立适当的间隔，包括没有间隔。中间螺圈70还可以用来在封堵器100展开期间将封堵器100偏置离开输送导丝21。
在任一实施方案中，支撑物70可具有约0.010英寸至约0.018英寸的外径D3。在实施方案中，外径D3约0.014英寸。支撑物70也可具有约2.0cm至约30cm的长度L3。在实施方案中，支撑物70的长度L3约7cm。
封堵器100还可设置在沿导丝组件20的长度定位的一对任选的不透辐射标记物带(radio-opaque marker band)之间的中间螺圈70上。可供选择地，保护螺圈35、缓冲螺圈60和/或中间螺圈70可包括不透辐射标记物。在备选实施方案中，导丝组件20可只包括单一的不透辐射标记物。不透辐射标记物的使用使得在脉管系统内放置时导丝组件20和封堵器100是可见的。这样的可见技术可包括传统方法，例如放射检查、射线照相术、超声波检查、核磁共振成像技术等。
可以根据以下方法及其变化在动脉瘤A的部位输送和展开封堵器100。封堵器100的输送包括将微导管1引入脉管系统，直到封堵器100到达要求治疗的部位。可以使用传统技术将微导管1引入脉管系统，例如在传统脉管导丝(未显示)上面推进或与传统脉管导丝同时推进。微导管1的定位可发生在微导管1容纳导丝组件20之前或发生在微导管1装载导丝组件20时。可以通过识别设置在微导管1上或设置在微导管1内的不透辐射标记物来确定微导管1在脉管系统内的位置。
在微导管1定位在所希望的位置之后，移去导丝并将导引鞘10的远端插入微导管1的近端，如图1所显示的。在实施方案中，穿过微导管1的近端处的插孔2引入导引鞘10的远端。在微导管1内推进导引鞘10，直到导引鞘10的远端顶部楔入微导管1内。在此位置，导引鞘10不能在微导管1内被进一步推进。然后，导引鞘10稳固地保持在此位置，同时穿过导引鞘10推进携带封堵器100的输送导丝组件20，直到封堵器100被推出导引鞘10进入微导管1内。
穿过微导管1推进导丝组件20和封堵器100，直到顶部螺圈29接近微导管1的远端。在此点，可以确定微导管1和导丝组件20的位置。然后，导丝组件20被推出微导管1并进入患者的脉管系统以便封堵器100的近端107定位在微导管1的远端的外部且邻近待治疗的区域。在这些步骤期间的任何位置点上都可以检测封堵器100的位置以确定封堵器100将正确地展开且在所希望的位置。这可以通过使用以上所描述的不透辐射标记物来实现。
当封堵器100的远端102被定位于微导管1的外面时，近端107将开始以图7箭头所显示的方向在脉管系统内扩展，同时远端102保持由保护螺圈35覆盖。当封堵器100处于正确位置后，输送导丝21旋转(见图8)，直到封堵器100的远端102移动离开保护螺圈35并在所希望的位置在脉管系统内展开。输送导丝21可按照需要来顺时针旋转或逆时针旋转以展开封堵器100。在实施方案中，例如，输送导丝21可在一个方向或两个方向上在两转和十转之间旋转。在另一实施例中，可通过顺时针旋转输送导丝21少于五转，例如，三转到五转来展开封堵器。在封堵器100展开之后，输送导丝21可缩回微导管100并从人体移去。
在图9所显示的备选或其他展开步骤中，封堵器100和微导管1的内表面之间的摩擦导致封堵器100的远端从保护螺圈35分开。这种摩擦可通过打开封堵器100和/或朝着微导管1的内表面偏置封堵器100的中间螺圈70来形成摩擦。微导管1和封堵器100之间的摩擦有助于展开封堵器100。在当封堵器100在展开期间没有打开和从保护螺圈35分离的那些情形下，封堵器1 00和微导管1的内表面之间的摩擦将使封堵器100移动离开保护螺圈35，因为输送导丝21和微导管1互相相对移动。然后，输送导丝21旋转且封堵器100在血管内展开。
在封堵器100径向自行扩展为平缓的、但稳固的、与血管的壁接触以便封堵动脉瘤A的颈部之后，可将微导管1从患者体内完全移去。可供选择地，可将微导管1留在脉管系统内的适当位置以允许在治疗位置附近插入其他工具或在治疗位置附近应用药物。
本发明可使用已知的材料。能用于封堵器100和导丝21的一种普通材料是一种镍-钛形状记忆合金镍钛诺，该材料可以成形并退火，在低温下变形，且通过加热能恢复到其原始形状，例如，当在人体内在体温下展开时。不透辐射标记物可由不透辐射材料形成，包括金属，例如铂或包括铋或钨的掺杂塑料以帮助可见。
此处所描述的装置和方法不限于在脉管系统内的展开和使用，而可以包括任何进一步的治疗用途。其他治疗部位可包括诸如器官体(organ body)等的人体部位或区域。用于实现本发明的以上所描述的装置和方法中的每一个的修改以及对于本技术领域的技术人员是显而易见的本发明的各方面的变化都落在权利要求的范围内。此外，没有部件、元件或方法步骤意欲专用于公众，而与部件、元件或方法步骤是否明确地描述在权利要求中无关。

Claims (29)

1.一种用于支撑和展开封堵器的系统，所述系统包括导引鞘和用于携带所述封堵器的组件，所述组件包括细长形柔性构件，所述细长形柔性构件具有包括保护螺圈的封堵器保持构件、近端设置的保持构件，以及支撑物，所述封堵器保持构件用于容纳所述封堵器的第一端，所述近端设置的保持构件用于啮合所述封堵器的第二端，所述支撑物沿所述细长形柔性构件的一部分延伸并具有用于啮合所述封堵器的内表面的外表面，所述封堵器可相对于所述支撑物移动。
2.根据权利要求1所述的系统，其中所述细长形柔性构件包括具有柔性无损伤顶部的导丝。
3.根据权利要求2所述的系统，其中所述导丝可相对于所述导引鞘移动。
4.根据权利要求3所述的系统，其中所述导丝具有至少两个不同直径的区段。
5.根据权利要求3所述的系统，其中所述导丝具有不同曲率的区段。
6.根据权利要求1所述的系统，其中所述支撑物包围所述细长形柔性构件的一部分。
7.根据权利要求1所述的系统，其中所述近端设置的保持构件包括偏置构件，当所述封堵器被定位在所述支撑物上时，所述偏置构件将所述封堵器推向所述柔性构件的远端。
8.根据权利要求1所述的系统，其中所述近端设置的保持构件包括所述细长形柔性构件的一部分。
9.根据权利要求1所述的系统，其中所述封堵器保持构件包括用于容纳所述封堵器的所述第一端的内部开口。
10.根据权利要求1所述的系统，进一步包括导管，所述组件和所述封堵器可定位在所述导管内。
11.根据权利要求1所述的系统，其中所述支撑物包括围绕所述细长形柔性构件设置的细长形螺圈。
12.根据权利要求1所述的系统，其中所述细长形构件包括柔性导丝，所述柔性导丝可相对于所述导引鞘和所述封堵器旋转。
13.根据权利要求1所述的系统，其中所述封堵器保持构件具有外表面，所述封堵器保持构件的所述外表面比所述支撑物的外表面从所述细长形构件的外表面延伸的远。
14.根据权利要求1所述的系统，其中所述封堵器保持构件包括用于保护所述封堵器的所述第一端的部分。
15.一种用于支撑和展开封堵器的系统，所述系统包括用于携带所述封堵器的组件，所述组件包括细长形构件，所述细长形构件包括柔性远端顶部部分、包括保护螺圈的保持构件以及支撑物，所述保持构件具有用于容纳和保持所述封堵器的第一端的部分，所述支撑物沿所述细长形柔性构件的一部分延伸并形成用于相对于所述细长形构件啮合并支撑所述封堵器的外表面，使得所述封堵器可相对于所述支撑物移动。
16.根据权利要求15所述的系统，其中所述保持构件具有比所述支撑物的外表面从所述细长形构件的外表面延伸更远的外表面。
17.根据权利要求15所述的系统，进一步包括用于携带所述组件的导引鞘。
18.根据权利要求15所述的系统，其中所述细长形构件包括柔性导丝。
19.根据权利要求18所述的系统，其中所述导丝具有至少两个具有不同的直径的区段。
20.根据权利要求18所述的系统，其中所述导丝具有不同曲率的区段。
21.根据权利要求15所述的系统，其中所述远端顶部部分包括无损伤的顶部。
22.根据权利要求15所述的系统，其中所述保持构件包括用于在展开所述封堵器之前容纳并保持所述封堵器的所述第一端的内部凹进部分。
23.根据权利要求15所述的系统，进一步包括与第一保持构件隔开的第二保持构件，以用来啮合封堵器的一部分并将所述封堵器推向所述第一保持构件。
24.根据权利要求15所述的系统，进一步包括导管，所述组件和所述封堵器可定位在所述导管内。
25.根据权利要求24所述的系统，其中所述细长形构件包括柔性导丝，所述柔性导丝可相对于所述导管和所述封堵器旋转。
26.根据权利要求15所述的系统，其中所述支撑物包括柔性螺圈，所述柔性螺圈在所述细长形构件的一部分上延伸且包围所述细长形构件的一部分。
27.根据权利要求15所述的系统，其中所述保持构件包括用于保护所述封堵器的所述第一端的一部分。
28.根据权利要求1所述的系统，其中所述系统被配置成展开自行扩展的封堵器。
29.根据权利要求15所述的系统，其中所述系统被配置成展开自行扩展的封堵器。
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