CN102525700A - 支架推进装置和无菌成套工具 - Google Patents

支架推进装置和无菌成套工具 Download PDF

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CN102525700A
CN102525700A CN201210014832XA CN201210014832A CN102525700A CN 102525700 A CN102525700 A CN 102525700A CN 201210014832X A CN201210014832X A CN 201210014832XA CN 201210014832 A CN201210014832 A CN 201210014832A CN 102525700 A CN102525700 A CN 102525700A
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support
oversheath
fastener
handle
towards
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CN102525700B (zh
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J·谢尔登
R·布思
G·博泽克
R·威兹德姆
K·比克
B·丹内克尔
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IDEV Technologies Inc
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IDEV Technologies Inc
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Abstract

一种装置，该装置包括：外护套；以及置于所述外护套内的支架接合件；其中，经由所述支架接合件对支架的至少两个接合时段，能够将所述支架朝向远侧推出所述外护套，每个所述接合时段构造为朝向远侧推出所述支架而不会伴随有所述外护套的机械性退回，并且每个所述接合时段之间间隔有构造为不朝向远侧推进所述支架的所述支架接合件对所述支架的非接合时段。

Description

支架推进装置和无菌成套工具
本申请是申请号为200780046619.4、申请日为2007年10月22日、发明名称为“支架推进装置和方法”的中国发明专利申请的分案申请。
相关申请的交叉引用
本申请要求申请日为2006年10月22日、申请号为60/862,456的美国临时专利申请的优先权，该申请的全部内容特通过引用予以合并。
技术领域
本发明主要涉及一种支架安置装置，该支架安置装置用于将支架安置在例如体内血管或管道内或者安置在用于测试或演示的结构(如聚合物管)内。
背景技术
专利号为5,372,600、5,433,723、5,707,376、5,772,668、5,776,142、5,968,052、6,514,261、6,599,296、7,052,511、7,122,050的美国专利以及公开号为20030040772、20050021123的美国专利申请中包括有多个支架输送装置的实施例。
发明内容
一方面，本发明装置(该装置也可以以支架展开装置为特征)的一些实施方式包括：外护套；以及置于所述外护套内的支架接合件；其中，经由所述支架接合件对支架的至少两个接合时段，能够将所述支架朝向远侧推出所述外护套，每个所述接合时段构造为朝向远侧推出所述支架而不会伴随有所述外护套的机械性退回，并且每个所述接合时段之间间隔有构造为不朝向远侧推进所述支架的所述支架接合件对所述支架的非接合时段。
另一方面，本发明提供一种无菌成套工具，该无菌成套工具包括上述的装置。
附图说明
下列附图仅是示例性地而非限制性地图示。这些附图显示了本发明输送装置的两种不同的实施方式，其中第二种实施方式显示在图13和图14中。此外，这些附图还显示了能够使支架密度在输送过程中改变的方法(图15A-15C)以及本发明演示方法中的一个演示方法的图解(图16)。
图1、图2A、图2B、图2C、图3A、图3B、图3D、图3E、图4至图7、图11、图12A、图13以及图14均按比例绘制(根据比例)，但缆索72的长度除外，该缆索72的长度可以根据需要改变。相同的附图标记并不一定表示相同的结构。更确切地说，相同的附图标记可以用于表示相似的特征或具有相似功能的特征。为了使附图清楚，并非每个实施方式的每个特征均在显示该实施方式的每幅附图中进行了标示。
具体实施方式
术语“含有(comprise)”(以及任何形式的“含有”，例如单数形式的“含有(comprises)”和现在分词形式的“含有(comprising)”)、“具有(have)”(以及任何形式的“具有”，例如单数形式的“具有(has)”和现在分词形式的“具有(having)”)、“包含(contain)”(以及任何形式的“包含”，例如单数形式的“包含(contains)”和现在分词形式的“包含(containing)”)、和“包括(include)”(以及任何形式的“包括”，例如单数形式的“包括(includes)”和现在分词形式的“包括(including)”)均是开放性的联系动词。因此，“含有”、“具有”、“包含”或“包括”一个或多个构件的装置或方法具有该一个或多个构件，但是并不限于仅具有该一个或多个构件或步骤。同样地，“含有”、“具有”、“包含”或“包括”一个或多个特征的装置的构件或方法的步骤具有该一个或多个特征，但是并不限于仅具有该一个或多个特征。此外，以某种方法构造的结构应当理解为至少以该方法构造，但是也可以以未说明的一种或多种方法构造。
本装置和方法中的任一个的任何实施方式可以由或基本由所述特征和/或步骤组成——而不是含有/包括/包含/具有所述特征和/或步骤。
术语“一(a)”或“一个(an)”定义为一个或多于一个，除非本公开内容明确作出其它要求。术语“基本上”或“大约”定义为至少接近(并包括)给定值或状态(优选地在10％范围内，更优选地在1％范围内，最优选地在0.1％范围内)。
图1以透视图的方式显示本装置的一种示例性的实施方式。装置10包括外护套20和连接到外护套20上的装置主体90(在该实施方式中，该装置主体90是一个构造为能够握在手中的手柄)。在该实施方式中，所述外护套与所述手柄连接为使得外护套不能相对于手柄移动(即，这二者以固定的关系彼此连接)。外护套20为中空件，该中空件构造为能够使得输送前处于约束(例如，拉长)状态的支架置于其中。
图1的实施方式的装置主体90附近的部分以透视图的形式示于图2A中，并以截面图的形式示于图3A中。这些图显示了装置10包括用户可驱动件50，该用户可驱动件50连接到装置主体90上(并且，在该实施方式中，该用户可驱动件50安装到装置主体90上并能够相对于装置主体90滑动)，同时该用户可驱动件50还连接到构件40上，所述构件40在该实施方式中具有通道并且构造为安装在外护套20的内部。在图2A和图3A所示的实施方式中，用户可驱动件50可滑动地安装在装置主体90上并通过滑块51连接到构件40上。在一些实施方式中，滑块51可以包括偏压件(例如弹簧)，该偏压件将用户可驱动件50朝图3A中所示的位置偏压。在其他实施方式中，滑块51可以不包括偏压件。
装置10的用户可驱动件50、滑块51和构件40可以沿远、近侧方向(该远、近侧方向沿着所述装置的纵向轴线(未示出))移动，而在其他方向上的移动则通常受到限制。因此，用户可驱动件50(朝向近侧方向92)的近侧方向移动导致构件40的近侧方向移动，并且用户可驱动件50(朝向远侧方向91)的远侧方向移动导致构件40的远侧方向移动。在图示的实施方式中，可驱动构件50(朝向近侧或朝向远侧)移动的距离将转换成构件40移动的相同距离。这种转换可以根据需要增加或减少。如下文更详细的描述，构件40连接到支架接合件45上，在该支架接合件在支架的内腔内朝向远侧移动的至少一部分时间内，该支架接合件接合并驱动所负载的支架从所述外护套朝向远侧移动。
图2A还显示了装置10可以包括构件25，该构件25(可滑动地)连接于外护套20的外部。构件25可以构造为沿所述外护套的外表面相对自由地滑动，并且该构件25可以构造为与引导器的止血阀相互配合(参见图3B)。具体来说，构件25可以构造为部分地装配在引导器的内部并与止血阀相互配合，以使得血液体不会朝向所述装置的手柄回流，并且装置的外护套仍然可以相对自由地在构件25和引导器内滑动。就效果而言，构件25可以起到以下作用：减小所述装置的外护套和该外护套插入通过的引导器之间的摩擦，并同时保持外护套与患者的外部之间的基本流体密封。
参见图1、图4和图5，外护套20从装置主体90朝向远侧延伸。装置10还包括内部构件60，该内部构件60的一部分位于外护套20内。内部构件60(更具体地，在优选实施方式中为下述的图2D中所示的内部套管61)的远端连接到头椎体150上。内部构件60在轴向方向上不受外护套20的约束(因为两者具有差别较大的直径而使得两者不发生接触)，该内部构件60帮助头椎体150相对于外护套20移动，并且该内部构件60的尺寸形成为使得导丝可以穿过它(如同导丝可以穿过头椎体150一样)。在沿着外护套20的任何适当的位置上可以设置有射线透不过的标记27，以提供展开支架的辅助工具。例如，从外护套20的远端到标记27之间的距离可以是正被输送的支架在展开状态下的标称长度。图5显示了位于外护套20内的支架30的远端31。在一些实施方式中，构件40和支架接合件45均不连附在内部构件60上。因此，在内部构件60静止时构件40可以在内部构件60上朝向近侧移动。相似地，在内部构件60静止时支架接合件45也可以在内部构件60上朝向近侧和远侧移动。
再参照图2A和图3A，并同时参照图2C，用户可驱动件50可以进行的沿远近方向的移动受到装置90上的槽52和阻挡件120的限制。图2A所示的阻挡件120的第一位置121将用户可驱动件50的远侧行程限制为小于槽52的全长。优选地，第一位置121与用户可驱动件50的最远端位置相对应，在该最远端位置，支架接合件45仍然保持在外护套20内。这对应于用于推进支架30的适当结构。阻挡件120优选地通过例如弹簧偏压到第一位置121。在图2C和图3A中，阻挡件120被旋转至第二位置122(如图2C所标记的)，如图所示，该第二位置122允许用户可驱动件50滑动通过该阻挡件120。
图2D为装置10的优选实施方式的配件的截面图，其中，该配件包括内部套管61形式的内部构件60的优选实施方式，所述内部套管61延伸为内部构件60的长度，并且构造成能容纳导丝。内部构件60还可以包括中间套管62，该中间套管62可以以任何合适的方式(例如采用注册商标为
Figure BDA0000131545500000051
型号为4014的粘合剂)在其远端(或在其它任何合适的位置上)固定到内部套管61上。中间套管62(可以为海波管(hypotube))也可以延伸至内部构件60的近端。内部构件60还可以包括外部套管63(可以为海波管)，该外部套管63以任何合适的方式(例如通过焊接)在其远端(或在其它任何合适的位置上)连接到中间套管62上；外部套管63也可以延伸至内部构件60的近端。内部构件60还可以包括移动限制套管64，该移动限制套管64以任何合适的方式(例如通过焊接)在其远端(或在其它任何合适的位置上)连接到外部套管63上。套管64可以构造为能够限制内部构件60相对于装置主体90的移动。更具体地说，套管64可以构造为能够(因其尺寸而)与装置主体90的空腔55的近侧开口(未标示)碰触(参见图3A)，并可以构造为能够在远侧与滑块51碰触(如果鲁尔接头(Luer fitting)100没有先与Y型转接器95碰触的话)。
图3B为放大的截面图，该截面图显示了构件25和引导器35之间的互相作用关系，其中构件25与引导器35的止血阀的密封圈31相互配合。
图3C为装置10的优选实施方式的配件的截面图，该配件包括近侧海波管41形式的构件40的优选实施方式，所述近侧海波管41可以以任何合适的方式(例如通过压进到台肩57处的压配合或采用合适的粘合剂，例如注册商标为
Figure BDA0000131545500000061
的粘合剂中的一种(如4014、4305、3321等型号的粘合剂))固定到滑块51上。滑块51通过销54固定到用户可驱动件50上，所述销54可以粘结到构件50上并压配合或粘结到滑块51上。构件40还可以包括中间管42，该中间管42在其近端以任何合适的方式(例如通过注册商标为
Figure BDA0000131545500000062
型号为4305的粘合剂)连接到近侧海波管41上，并且在其远端以任何合适的方式(例如通过粘合剂)连接到支撑管46上(该支撑管46以任何合适的方式(例如通过粘合剂)依次地连接于支架接合件45上)。构件40还可以包括支撑管43，该支撑管43位于中间管42上，并且邻接近侧海波管41的远端。支撑管43可以在任何合适的位置通过使用任何合适的粘合剂连接到中间管42上。所述支撑管可以构造为能够增加中间管42的刚性。构件40还可以包括返回护套止退件(resheathing stop)44，该返回护套止退件44穿套在中间管42上并且邻接支撑管43的远端。返回护套止退件44可以在任何合适的位置通过使用任何合适的粘结剂连接于中间管42上。返回护套止退件44可以构造为如果所述支架在输送过程中应当要被收回护套内时，该返回护套止退件44能够防止外护套20所包围的支架(在该图中未示出)朝向近侧移动。图示的配件还包括硅树脂密封圈56，该硅树脂密封圈56设计成能够防止环绕在所述内部构件60(更具体地是作为内部构件60的优选实施方式的部件的外部海波管)外部的液体回流，并且通过不锈钢护圈58固定到位。
参见图6，构件40延伸为使得该构件40的一部分位于外护套20内。优选地，构件40为中空的，并且该构件40的通道容纳位于该构件40内的内部管60的一部分。该构件40的替代实施方式也可以为非中空的。
参见图6至图7，构件40连接到支架接合件45上，在该实施方式中，支架接合件45的形状像铲子或铲斗。更具体地说，在图示的优选实施方式中，构件40的中间管42连接到支撑管46上，该支撑管46连接到支架接合件45上。支架接合件45至少部分位于支架30的内腔内。当构件40响应用户可驱动件50的远侧移动而朝向远侧移动时，支架接合件45与支架30接合，并沿着外护套20推进支架30。在优选的实施方式中，支架接合件45朝向近侧的移动不会导致支架30的移动。构件40以此方式重复进行朝向远侧和近侧的往复移动，从而导致支架30的推进，直至支架30离开外护套20。因此，本领域技术人员应当理解的是，装置10的所述实施方式构造为使得用户能够通过支架接合件45对支架的多次接合而朝向远侧将支架30推出外护套20，其中，每次接合：发生在支架30的近端和远端之间，朝向远侧驱动支架30而不会伴随有外护套20的机械性退回，并且通过一段不向远侧驱动支架30的时段与任何随后的接合间隔开；以及导致每次接合的用户与装置10的接触(该接触发生在用户可驱动件50上)的最近侧点位于装置主体90的近端或远离于装置主体90的近端。支架接合件45可以包括挠曲槽48(flex slot)，所述挠曲槽48具有圆形的、哑铃形状的末端，该挠曲槽48能够帮助缓解疲劳应力断裂等情况，并且在支架接合件45在支架30的内腔内朝向近侧滑动时，允许支架接合件45向内弯折。如图7所示，优选地，支架接合件45的性能通过选择适当的形状来实现。替代实施方式可以采用挠性的、铰接的或者其他变化形状的支架接合件来实现支架的推进。支架接合件的结构可以选择为最适合于待部署的支架的类型。当支架30为编织的、自伸展的支架时，可以采用例如美国专利7,018,401中所公开类型的支架接合件，该美国专利7018401通过引用而结合于此，支架接合件45优选地构造为(如图中所示)：(a)当朝向远侧驱动支架时，在支架30的相对侧上接合金属丝交叉点，并且(b)向内弯折(至少部分地是由于支架接合件的挠曲槽48而形成)并且在支架管内腔内朝向近侧滑动。
图8给出了支架推进过程的示意性图示。支架30的远端31已经离开外护套20并且已经伸展。如箭头所示，构件40来回地朝向近侧和远侧移动。当支架接合件45朝向远侧移动时，该支架接合件45接合并推进支架30，从而将支架30推出外护套20。当支架接合件45朝向近侧移动时，由于支架接合件45的形状，支架30不发生推进。替代地，当在用户可驱动件50朝向近侧移动的过程中支架接合件45移动返回并遇到支架30的部分(例如金属丝部分)时，支架接合件45的结构使得该支架接合件45能够向内弯折，而不会扰乱支架相对于外护套的轴向位置。优选地，支架30推进的实现不会伴随有外护套20的机械性退回，并且也不会伴随有外护套20相对于支架主体90的移动(除了由于患者身体的移动、颤动等所导致的偶然移动之外)。
图9至图10示意性地显示了支架在体内血管的展开。图9描述了处于约束结构或拉长结构的支架30。这是当支架30位于装置10的外护套20内时该支架30的结构的一种实施例。图10显示了在体内血管160中处于伸展状态的支架30，这是自伸展支架在离开外护套20时会进行的一个状态。
在一些实施方式中，本发明的装置还可以包括支架保持构件，该支架保持构件构造为如果支架还没有被完全推出护套，能够允许操作者在推进和/或展开过程中将支架收回护套中。参见图11和图12A，装置10包括连接到支架30的近端32上的支架保持构件70。在优选的实施方式中，即使在支架接合件45朝向近侧移动的过程中，只要支架30的近端32还处于外护套20内，支架保持构件70的远端部分71和支架30之间均存在接触。当支架30的近端32推进到外护套20的外部时，支架30的半径膨胀至比支架保持构件70的远端部分71的最大宽度(沿图中所示的径向方向截取)还要大。结果，支架30和支架保持构件70之间的接触终止，并完成支架30的展开。相应地，只要支架30的近端部分(具体来说是该支架的连接到支架保持构件70的近端部分)还处于外护套20之内，则(通过操作者的动作)就可以操作支架保持构件70以将支架30朝向近侧收回进外护套20内。
参见图2A、图3A以及图11至图12，支架保持构件70的近端部分72(也显示于图3B中)为缆索或类似装置，只要支架30的近端部分处于外护套20内，该缆索或类似装置就能够帮助将支架30朝向近侧收回进外护套20内的，并且该缆索或类似装置的特征可以为支架保持缆索。支架保持构件70的远端部分71可以为一段管子(例如海波管)，该段管子设置有多个径向凸出的尖端73，这些尖端73与编织类型的支架30上的孔接合。所述管子可以以任何合适的方式(例如通过焊接)连接到近端部分72上。
如图1和图2A所示，Y型转接器95可以连接到装置主体90的近端部分上。内部管60可以布置为贯穿直臂96，并且近端部分(即缆索)72可以布置为贯穿Y型转接器95的斜臂97。如图2B所示，支架保持构件的位置标记93可以连接到缆索72上，并且可以沿着缆索72定位成连接于支架保持构件的所述支架的相对位置。例如，所述标记可以为一段热收缩管，该标记可以沿着所述缆索定位，以使得当该标记伸入斜臂97的周界时，所述支架将完全离开外护套20。通过该方式，操作者具有表示支架离开外护套多远的可视指示器。图1和图2A还示出了支架保持构件可以包括指型构件98，该指型构件98以任何合适的方式(例如通过注册商标为
Figure BDA0000131545500000101
的粘合剂)连接到缆索72上，从而为使用者提供握持物以操作支架保持构件。图12B显示了支架保持构件70的优选实施方式，其中，以剖视方式显示指型构件98，并且显示了缆索72和指型构件98(如图所示，该指型构件98可以具有螺纹连接在一起的内部件和外部件)之间的(用于粘合剂或类似物的)连接位置99的实施例。
优选地，装置10包括侧端口110(连接到装置主体90上)和鲁尔接头(Luer fitting)100(连接到内部管60的近端62上)以分别允许对外护套20和内部管60进行冲洗。可以用生理盐水进行冲洗，并且可以在操作前进行冲洗。本发明装置的替代实施方式可以包括用于冲洗外护套20和内部管60的其他设计，或者也可以构造为不能进行冲洗。图3D为装置10的俯视图，并且标出了装置主体90的远端附近的详细剖视图，该剖视图更详细地示于图3E中。
参见图2C，阻挡件120的第二位置122允许用户可驱动件50在槽52的全部长度上朝向远侧移动。此时，用户可驱动件50的最远端位置对应于如下位置：在该位置支架接合件45位于外护套20的外部(离开外护套20)，并因此处于使得支架30将被推出护套20并处于伸展状态的区域内。处在该位置的支架与支架保持构件70的远端部分71分离，从而该支架不能再被收回外护套20内。此外，处于伸展状态下的支架在支架接合件45上将具有径向间隙。本发明装置的替代实施方式可以使用其他的设计来限制用户可驱动件50的移动，或没有可调节的限制移动的特征。
图13至图14描述了本发明装置的另一种实施方式，该装置的实施方式包括连接到支架保持构件70的近端部分72的捕获装置80。捕获装置80用来在支架接合件45推进支架30时仅释放适量的近端部分72。捕获装置80包括止挡件，该止挡件用于在支架30完全展开之前阻止支架30从外护套20朝向远侧推进。该止挡件(该止挡件可以是一段管子，例如海波管，该段管子在合适的位置连接到近端部分72上)为操作者提供进一步推进会导致支架完全展开的位置的反馈(因此，该止挡件能够用来作为不能再收回支架的位置指示器)。在该位置，操作者可以选择通过朝向近侧拉紧支架保持构件70而将支架30收回到外护套20内以重新定位，或者通过压下展开挡杆81(这能够使得所述止挡件避过展开档杆，并允许支架保持构件继续朝向远侧推进)并通过用户可驱动件50的继续推进来继续进行支架的展开。
如果操作者选择将支架30收回外护套20内以重新定位，操作者可以操作保持拉杆84，这(在图示的实施方式中)使得捕获装置80与装置主体90分离，并允许操作者通过朝向近侧拉动支架保持构件70的近端部分72来收回支架30。当支架30被收回进外护套20中后，捕获装置80的保持滑轮82和弹簧83工作以将支架保持构件70的多余的松弛部分收起。在该实施方式中，支架保持构件70的近端部分72穿过装置主体内的不位于中心的装置主体90的部分。包括捕获装置的本装置的另一种实施方式可以包括构造为不同于捕获装置80的捕获装置，例如自动捕获装置。此外，捕获装置80可以连接到图1所示实施方式的装置10的斜臂97上以代替指型构件98。
本发明的装置可以为一次性的，并可以在使用任何合适的技术杀菌(例如使用乙撑氧气体杀菌)后包装在包、袋子、盒子或其他合适的容器内。外护套的远端和头椎体的近端之间可以存在微小的间隙以允许消毒气体流过整个装置。所述容器可以包括使用装置的说明，该说明印刷在容器上或包括在容器内部。当装置从容器中取出时，可以使用生理盐水来冲洗外护套及其容纳物和内部管。头椎体和外护套之间的空隙随后可以通过朝向近侧拉紧连接于头椎体的内部管构件而封闭。如果该过程涉及将支架安置到血管中，可以使用用于将装置定位在适当位置的任何合适的技术(例如，塞尔丁格(Seldinger)技术)。装置的头椎体(该头椎体可以为挠性的尖端)可以为射线透不过的，并且可以作为装置的最远端的标记。由任何合适的材料(例如铂带或由任何合适的铂合金制成的带)制成的另一个射线透不过的标记可以连接到装置的接近头椎体的一部分上，例如连接到外护套(如上所述)、构件40或内部构件上以形成装置的最近端的标记。操作者可以使用这两个标记来确定装置相对于目标损伤的位置，从而能够准确地展开支架。
本发明的方法包括支架推进方法，该支架推进方法用于朝向远侧将支架推出护套(例如外护套20)并使得支架进入管状结构中。在一些实施方式中，所述管状结构是动物组织(例如人体血管)，在其它一些实施方式中，所述管状结构不是动物组织，而是包括聚合物结构，该聚合物结构能够用来测试特定的装置技术，或者向一个人或多个人(例如考虑将该装置或者该支架推进技术用于他或她的实践中的医生)演示支架的推进。
本发明的支架推进方法的一些实施方式包括通过重复地使支架在其远端和近端之间与支架接合件(例如支架接合件45)接合，来朝向远侧将支架(例如支架30)推出护套(例如外护套20)并进入管状结构，其中，所述接合中的至少两次接合间隔有非接合时段；并且当将支架朝向远侧推出护套时，通过改变所述护套相对于所述管状结构的轴向位置来改变所述支架在所述管状结构内的轴向密度。当将支架朝向远侧推出护套时，操作者将装置的剩余部分相对于管状结构朝向近侧收回，以使得支架的已展开的部分相对于所述支架展开进入的管状结构(例如，人体组织)保持固定。可以改变装置的剩余部分的收回速度以改变支架的轴向密度：较低的收回速度增加支架的轴向密度，而较快的收回速度则降低支架的轴向密度。在例如需要较大的环强度(hoop strength)以保持管状结构的开放性的位置上，例如在如图15A所示的沿着动脉200的变窄的区域210的位置上，可以适当地增加支架的轴向密度。在例如期望或要求流体从侧面流入支架的一部分的位置上或者在第二支架穿入的位置上(这两个位置中的任一个可以存在于如图15B所示的血管250的组织侧分支260处)，可以适当地减小支架的轴向密度。
本发明的支架推进方法的一些实施方式包括通过重复地使支架在其远端和近端之间与支架接合件(例如支架接合件45)接合，来朝向远侧将支架(例如支架30)推出护套(例如外护套20)并进入管状结构，其中，所述接合中的至少两次接合间隔有非接合时段；以及在支架的近端使支架与位于护套内的支架保持构件(例如支架保持构件70)接合。
在一些实施方式中，将支架朝向远侧推离护套的接合可以通过使用一种装置实现，该装置构造为在支架被朝向远侧被推动时不会机械地伴随有护套的退回，例如，采用附图中所示的本发明的装置。在这些实施方式中的管状结构可以为肌体组织的管状结构，例如血管或管道，或者可以为非动物组织的管状结构，例如聚合物管300(参见图15C)。无论如何，在一些实施方式中，该方法还可以包括在支架近端使支架与位于护套内的支架保持构件接合。所述支架保持构件可以包括支架保持缆索(stent-retention line)，并且该方法还可以包括，在支架被部分地推出护套后，通过移动所述支架保持缆索将支架收回护套内。操作者可以通过使用拇指移动用户可驱动件(例如用户可驱动件50)来实现对支架的推进。所述支架可以是编织而成的，支架接合件可以接合支架的多个金属丝交叉点并在推进支架的接合过程中朝向远侧移动，并且支架接合件可以在非接合期间在支架的内腔内朝向近侧滑动。
本发明方法中的一些方法是指导另一个人或另一些人如何将支架推出护套并进入管状结构的方法。本发明的支架推进指导方法的一些实施方式包括指导人们如何使用支架输送装置(例如装置10)，该支架输送装置包括护套(例如外护套20)和置于护套内的支架(例如支架30)。该指导方法可以包括向人们演示以下步骤：通过重复使支架在其远端和近端与支架接合件(例如支架接合件45)接合，以朝向远侧将支架推出护套并进入管状结构中，其中，所述接合中的至少两次接合间隔非接合时段；以及当支架被朝向远侧推出护套时，通过改变护套相对于管状结构的轴向位置来改变支架在管状结构内的轴向密度。
本发明的支架推进指导方法的一些实施方式可以包括指导人们如何使用支架输送装置(例如装置10)，该支架输送装置包括护套(例如外护套20)和置于护套内的支架(例如支架30)。该指导方法可以包括向人们演示以下步骤：通过重复地使支架在其远端和近端与支架接合件(例如支架接合件45)接合，以朝向远侧将支架推出护套并进入管状结构中，其中，所述接合中的至少两次接合间隔有非接合时段；以及在支架的近端使支架与置于护套内的支架保持构件(例如支架保持构件70)接合。
在一些实施方式中该指导方法可以通过向在场的人进行现场演示而实现，在其他实施方式中则可以通过为人们播放录制演示或模拟演示而实现。录制演示的实例是一种由人来实施并拍摄在相机上的演示。模拟演示的实例是一种不是实际发生的、而是通过使用计算机系统和图形程序来形成的演示。在录制演示或模拟演示的情形下，该演示可以以任何合适的形式存在，例如DVD或任何合适的视频文件(例如.mpg、.mov、.qt、.rm、.swf或.wmv文件)，并且该指导方法可以通过使用任何合适的计算机系统向观众播放该演示而实现。一个或多个观众可以使演示播放。例如，观众通过互联网或任何提供了文件途径的合适的计算机系统，就可以获得录制的或模拟的演示文件。参见图16。
在涉及将支架输送进肌体组织结构内的本发明的方法的实施方式中，并且用于实现该方法的装置处于患者体内的要求位置上以能够开始进行支架的推进，支架接合件可以开始移动(例如联轴节式(ratcheting)移动)，以使得支架的远端(该支架也可以设置有一个或多个射线透不过的标记以能够在该过程中容易地观察到它的位置)离开装置的外护套，但是该离开并没有达到使支架伸展以接触肌体组织结构的程度。如果支架的远端接近于操作者所期望的位置，并且使用了支架保持构件，可以朝向近侧拉动所述支架保持构件以将支架收回护套内并将装置重新定位；如果支架远离操作者所期望的位置，可以朝向近侧将整个装置收回，并且继续进行展开过程。
本发明的装置的不同特征能够由可商购得到的、医用材料制成。例如，头椎体150可以由嵌段聚醚酰胺(例如购自美国宾夕法尼亚州费城ArkemaInc的注册商标为
Figure BDA0000131545500000151
的树脂)制成。内部构件60的远端部分(例如内部套管61)可以由聚酰亚胺制得，并连接到由不锈钢(例如304或316L不锈钢)海波管制成的更近端的部分上。连接到内部构件60(例如外部套管63)上的鲁尔接头(Luer fitting)100可以由聚碳酸酯制得。外护套20可以由编织的嵌段聚醚酰胺(例如，编织的树脂)制得。装置主体90、用户可驱动件90、滑块51和阻挡件120可以由ABS(丙烯睛-丁二烯-苯乙烯)塑料、聚碳酸酯或注册商标为
Figure BDA0000131545500000153
的缩醛树脂(购自DuPont公司)。如上所述，阻挡件120可以连接到偏压它的不锈钢弹簧上。构件40可以具有由聚酰亚胺形成的轴管(或者如在优选实施方式中具有由聚酰亚胺或镍钛合金海波管制成的一系列的轴管)，并且支架接合件45可以包括或连接于：一小段镍钛合金海波管(例如管46)上，该一小段镍钛合金海波管通过合适的粘合剂(例如通过包含有氰基丙烯酸酯的、注册商标为
Figure BDA0000131545500000154
的粘合剂)连接到所述聚酰亚胺轴管上；以及一段镍钛合金海波管，该段镍钛合金海波管形成为需要的形状并焊接(例如，激光焊接)到所述一小段镍钛合金海波管上。支架保持构件70可以包括缠绕的不锈钢丝(用作近端部分72)，该不锈钢丝包覆有尼龙、FEP(氟化乙丙烯)管、或PET(聚酯)管之类的材料，并且近端部分71可以由不锈钢海波管制成。此外，可以采取措施以减少在使用本装置过程中彼此接触或可能接触(例如支架和外护套之间的接触)的部件之间的摩擦。
本发明的装置可以用于输送编织的自伸展的支架，所述支架包括由多根线丝(例如由金属丝)编织而成的支架。可以使用的编织方法的一些实例包括美国专利6,792,979和7,048,014中的那些编织方法，该两篇美国专利通过引用结合于此。在支架的线丝是镍钛合金制成的金属丝时，编织支架的线丝可以终止在线丝端(例如，金属丝端)，然后使用小片的材料(例如镍钛合金海波管)将这些线丝端结合在一起。可以通过任何合适的技术对该支架进行钝化处理，以从支架表面除去在任何热处理和退火过程中形成的氧化层，从而改善支架材料的表面光洁度和耐腐蚀性。美国专利申请11/876,666中给出了可以通过本装置而使用的支架(包括可以由支架接合件45接合的线丝交叉点)的合适的支架制造技术，该美国专利申请通过引用结合于此。
应该理解的是，本发明的装置和方法不限于所公开的具体形式。相反地，它们应当覆盖落入权利要求范围内的所有修改、等同物和替换。例如，尽管附图中显示的本装置的实施方式包括响应操作者输入而移动相同距离的支架接合件和用户可驱动件，但本发明装置的其它实施方式可以包括传动装置或其他机构，该传动装置或其他机构在用户可驱动件移动的距离与导致支架接合件所移动的距离之间形成一个不是1∶1的比率(从而往复移动构件移动的距离可以大于或小于可驱动构件的移动距离)。此外，另一些实施方式可以通过其他的结构来实现支架的周期性接合以朝向远侧推进支架，例如，通过与美国专利5,968,052或美国专利6,514,261中所公开的挤压触发(squeeze-trigger)机构相类似的机构(该两篇美国专利通过引用而结合于此)，或者通过具有凸轮部分的、旋转式而不是平移式的支架接合件，其中所述凸轮部分构造为在特定旋转的一部分中接合支架，而在该旋转的另一部分中不接合支架。此外，另一些实施方式也可以采用实现支架接合件(例如支架接合件45)往复移动的其他形式，例如通过其它形式的操作者输入件，像通过凸轮连接于支架接合件的旋转式用户可驱动输入件(而不是如图所示的平移式输入件)。
权利要求不应理解为包括“方法加功能限制”或“步骤加功能限制”，除非在特定的权利要求中分别使用了术语“用于......的装置”或“用于......的步骤”来明确地表明了该种限制。

Claims (22)

1.一种装置，该装置包括：
外护套；以及
置于所述外护套内的支架接合件；
其中，经由所述支架接合件对支架的至少两个接合时段，能够将所述支架朝向远侧推出所述外护套，每个所述接合时段构造为朝向远侧推出所述支架而不会伴随有所述外护套的机械性退回，并且每个所述接合时段之间间隔有构造为不朝向远侧推进所述支架的所述支架接合件对所述支架的非接合时段。
2.根据权利要求1所述的装置，其中，所述装置还包括位于所述外护套内的支架。
3.根据权利要求2所述的装置，其中，所述支架具有远端、近端和在所述远端和所述近端之间延伸的内腔，并且其中所述支架接合件设置为至少部分位于所述支架的所述内腔内。
4.根据权利要求2所述的装置，其中，通过所述支架接合件将所述支架推出所述外护套后，所述支架具有不同的轴向密度。
5.根据权利要求2所述的装置，其中，所述支架具有近端，并且其中所述装置还包括与所述支架的所述近端接合的支架保持构件。
6.根据权利要求2所述的装置，其中，所述支架包括多条编织线。
7.根据权利要求6所述的装置，其中，在每个所述接合时段中所述支架接合件构造为接合线丝交叉点，并且其中，在每个所述非接合时段中所述支架接合件构造为向内弯折并朝向近侧滑动。
8.根据权利要求1所述的装置，其中，所述装置还包括连接到所述外护套的手柄，所述外护套相对于所述手柄静止。
9.根据权利要求8所述的装置，其中，所述手柄具有近端，并且其中，导致每次接合的使用者与所述装置接触的最近侧点位于所述手柄的近端或者远离所述手柄的近端。
10.根据权利要求8所述的装置，其中，所述装置还包括用户可驱动件，该用户可驱动件连接到所述手柄上，并且还通过具有通道的构件连接到所述支架接合件。
11.根据权利要求10所述的装置，其中，所述装置还包括内部构件，该内部构件的一部分位于所述具有通道的构件的内部，并且该内部构件构造为容纳导丝。
12.根据权利要求10所述的装置，其中，所述用户可驱动件能够在所述手柄的槽内移动。
13.根据权利要求10所述的装置，其中，所述装置还包括具有第一位置的阻挡件，所述第一位置限制所述用户可驱动件朝向远侧推进。
14.根据权利要求13所述的装置，其中，所述阻挡件具有第二位置，该第二位置不限制所述用户可驱动件朝向远侧推进，并且其中所述阻挡件在所述第一位置中被偏压。
15.根据权利要求1所述的装置，其中，所述支架接合件的形状像铲斗。
16.根据权利要求1所述的装置，其中，所述支架接合件的形状像铲子。
17.根据权利要求1所述的装置，其中，所述支架接合件具有挠性的部分。
18.根据权利要求1所述的装置，其中，所述支架接合件包括曲槽。
19.根据权利要求18所述的装置，其中，所述曲槽具有圆形的、哑铃形状的末端。
20.根据权利要求1所述的装置，其中，所述装置还包括构造为与所述支架的近端连接的支架保持构件。
21.根据权利要求20所述的装置，其中，所述装置还包括：
连接到所述外护套的手柄；以及
连接到所述手柄的Y型转接器；
其中，所述支架保持构件包括远端部分和支架保持缆索，该支架保持缆索从所述Y型转接器的分支的外部延伸，并且穿过该分支、所述手柄以及所述外护套的一部分延伸到所述支架保持构件的远端部分。
22.一种无菌成套工具，该无菌成套工具包括根据权利要求1-21中任意一项所述的装置。
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