CN101610809A - 导管组件及其构件 - Google Patents

导管组件及其构件 Download PDF

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CN101610809A
CN101610809A CNA2007800489800A CN200780048980A CN101610809A CN 101610809 A CN101610809 A CN 101610809A CN A2007800489800 A CNA2007800489800 A CN A2007800489800A CN 200780048980 A CN200780048980 A CN 200780048980A CN 101610809 A CN101610809 A CN 101610809A
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pin
tube component
hub seat
conduit tube
component according
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CN101610809B (zh
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K·沃尔
M·泽贝斯
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B Braun Melsungen AG
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B Braun Melsungen AG
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Abstract

本文中大体讨论了导管组件，且特别地延伸到对具有尖端保护器、阀、阀开启器及可选地具有针擦拭器的导管组件的讨论。阀开启器设置在导管毂座内部，且构造成以便由IV套件luer连接器推压，以在成功插入导管之后打开阀，以使流体或其它溶液通过导管。结合了尖端保护器，以阻挡针尖并且防止其发生意外针刺。可选地包括擦拭器，以在从导管中抽回针时擦去针上的血液沉积。

Description

导管组件及其构件
[0001]本文中大体讨论了导管组件，且特别地延伸到对具有尖端保护器、阀、阀开启器及可选地具有针擦拭器的导管组件的讨论。
背景
[0002]用于IV(静脉内的)导管组件的插入程序包含四个基本步骤：(1)医护人员将针和导管一起插入患者的静脉中；(2)在将针尖插入静脉中之后，医护人员通过用他或她的手指推压导管来使导管前进到患者的静脉中；(3)医护人员通过抓住毂座(hub)端部(与针尖端部相对)来抽回针，同时用他或她的空闲的手将压力施加于插入位点处的患者皮肤上，以阻止血液流动通过导管；以及(4)医护人员然后用胶带将导管的暴露的端部(导管毂座)连在患者的皮肤上，且将其连接到待输入患者的静脉中的流体的源上。
[0003]问题是紧接在从患者的静脉中抽回针之后，医护人员(其此时与至少两个紧急的程序有关)必须将暴露的针尖放置在附近的位置处，且处理完成抽回针所需的任务。正是在这个时候，暴露的针尖会引起意外针刺的危险，在这种情况下，这使得医护人员易受各种危险的血源性病原体(包括AIDS和肝炎)的传播的危害。
[0004]其它针类型类似地使医护人员暴露于意外针刺的风险。例如，使用直针、Huber针、硬膜针等实施注射的医生可能将用过的针放置在托盘上，以便随后由护士处置。对于将用过的针放置在托盘上或工作台上到丢弃用过的针之间的这段时间，用过的针对于那些在针的附近或周围工作的人来说是疾病传播的潜在源。
[0005]因此，所有的针在使用之后必须立即盖上，以确保更好的人员安全。理想地，用于覆盖针尖的程序必须是被动的、自启动的，或者至少是易于执行的。此外，用于覆盖针的装置必须可靠且结实。
[0006]更有利地，导管组件中应该结合有阀，以最大限度地减小成功插入导管之后的血液暴露。此外，由于血液与针发生接触且沉积在针上，所以针组件应该进一步结合用于在抽回针时擦拭沉积有血液的针的机构。
概述
[0007]根据本发明的多方面，提供了一种导管组件，其包括：包括壳体的第一毂座，该壳体包括外表面和限定了内部腔体的内表面；附连到第一毂座上且朝第一毂座的远侧延伸的管体；包括壳体的第二毂座，该壳体包括外表面和限定了内部腔体的内表面；具有针尖的针，其附连到第二毂座上且朝第二毂座的远侧凸出并进入管体中；阀，其包括顶面，从其上悬出的边缘，以及在顶面上的、使针通过其而凸出的开口；包括促动端的阀开启器，至少一条腿自促动端朝近侧延伸；以及包括周边的擦拭器，该周边限定了开口且针与该周边接触，以用于在远离管体而拉回针时擦拭该针。
[0008]本发明的其它方面包括导管组件，其包括：a)包括壳体的导管毂座，该壳体包括外表面和限定了内部腔体的内表面；b)附连到导管毂座上且朝导管毂座的远侧延伸的导管管体；c)包括壳体的针毂座；d)具有针尖的针，其附连到针毂座上且朝针毂座的远侧凸出并进入导管管体中；e)布置在导管毂座的内部腔体中的用于限制血液回流的阀；f)布置在阀的近侧的用于打开阀的阀开启器；以及g)布置成邻近阀开启器的用于阻挡针尖的尖端保护器，其中尖端保护器包括：(1)具有内表面的尖端保护器壳体；(2)自尖端保护器壳体的远侧壁延伸、朝向导管毂座的内表面偏置的第一臂；(3)自尖端保护器壳体的近侧壁延伸、朝向导管毂座的内表面偏置的第二臂；以及(4)自尖端保护器壳体的近侧壁延伸、抵靠着针的一侧偏置的第三臂。
[0009]根据本发明的其它方面，提供了一种导管组件，其包括：包括限定了内部腔体的壳体且具有朝其远侧延伸的导管管体的导管毂座；包括限定了内部腔体的壳体且具有针的针毂座，该针具有朝其远侧延伸的针尖；该针凸入导管管体中；布置在导管毂座的内部腔体内的具有开口的止血阀；邻近止血阀而布置且包括促动端的阀开启器，该促动端包括锥形部分和限定了朝其近侧延伸的间隙的一对腿；使针穿过其中以便在从导管管体中拉回针时擦拭该针的擦拭器；以及其中，包括臂和壁的尖端保护器，该壁包括开口，该尖端保护器布置在由两个腿限定的间隙中。
[0010]根据本发明的另外其它方面，包括通过在导管毂座的内壁表面内形成用于与两个腿协作的两个轴向地延伸的下切口，来提供使阀开启器上的一对腿与导管毂座对准。
[0011]在本发明的一个优选实施例中，隆起的凸起或凸出部形成于导管毂座的内部腔体内，以便在远离导管毂座而拉回针毂座期间，使尖端保护器保持在导管毂座内。
[0012]在本发明的其它方面中，O形环形式的擦拭器用于从针上擦去血液沉积。
[0013]参看说明书、权利要求书和附图，可更好地了解本文所提供的导管组件的其它方面和特征，且其可得到更好的理解。
附图简述
[0014]附图包括：
[0015]图1是根据本发明的多方面提供的导管组件的截面侧视图；
[0016]图2是针和针毂座从其中移除的图1的导管的截面侧视图；
[0017]图3是根据本发明的多方面提供的安全导管组件的局部截面侧视图，该安全导管组件包括阀、阀开启器和尖端保护器；
[0018]图4是针毂座、针和尖端保护器从其中移除的图3的安全导管组件的局部截面侧视图；
[0019]图5A是IV套件luer连接器联接到导管毂座上且将阀开启器朝远侧推入阀中的图4的导管组件的截面侧视图；
[0020]图5B是与图3-5A的组件类似的一个备选导管组件的截面侧视图，其中阀开启器没有结合倒钩，以允许在抽回IV套件luer连接器时与阀脱离。
[0021]图6是尖端保护器覆盖针尖的针毂座和针的截面侧视图；
[0022]图7是图6的尖端保护器的透视图；
[0023]图8A是根据本发明的多方面提供的、包括两个切口的擦拭器的俯视图；
[0024]图8B是根据本发明的多方面提供的阀开启器的透视图，该阀开启器具有附连到面向近侧的附连表面上的根据图8A的擦拭器；
[0025]图8C是根据本发明的多方面提供的导管组件的截面侧视图，该导管组件具有布置在导管毂座内部的包括擦拭器的图8B的阀开启器；
[0026]图9A是根据本发明的多方面提供的第一备选擦拭器的俯视图；
[0027]图9B是根据本发明的多方面提供的第二备选擦拭器的俯视图；
[0028]图9C是根据本发明的多方面提供的第三备选擦拭器的俯视图；
[0029]图9D是根据本发明的多方面提供的导管组件的截面侧视图，该导管组件具有布置在阀和阀开启器的远侧的擦拭器；
[0030]图10A是通过具有附连到其上以便擦拭针的擦拭器的阀开启器而凸出的针的透视图；
[0031]图10B是图10A的阀开启器的局部透视图和截面图；
[0032]图11是具有穿过其中的针和类似于O形环的擦拭器的一个备选阀开启器的局部透视图和截面图；
[0033]图12是具有穿过其中的针和与环形凹槽对准的擦拭器的一个备选阀开启器的局部透视图和截面图；
[0034]图13是根据本发明的多方面提供的、包括布置在导管和针毂座之间的第三壳体的又一个备选导管组件的截面侧视图；以及
[0035]图14是沿正交平面得到的图13的导管组件的截面侧视图。
详细描述
[0036]结合附图在以下阐述的详细描述意图作为导管组件的目前优选的实施例的描述，以便与根据本发明的多方面提供的阀和针尖保护器一起使用，而且该详细描述不意图代表其中可构造或使用本发明的唯独的形式。本描述结合所说明的实施例阐述了用于构造和使用本发明的导管组件的特征和步骤。然而，将理解，可通过不同的实施例实现的相同或等效功能和结构也意图包括在本发明的精神和范围内，尤其是结合了本文中所包括的不同实施例中所显示的特征的组合的那些。如本文中其它处所表示，相同元件标号意图表明相同的或类似的元件或特征。
[0037]现参看图1，显示了根据本发明的多方面提供的导管组件的局部截面侧视图，其大体标示为10。导管组件10包括附连到具有针16的导管毂座14上的导管管体12，针16附连到针毂座18上，且针16通过导管管体12凸出于准备好可用的位置。针16具有尖锐的针尖72和褶皱、凸起或夹扣接合(clip engagement)部分73。导管毂座14包括外表面20和限定了内部腔体的内表面。针毂座鼻部分26优选凸入导管毂座14的内部腔体以及结合在导管毂座14和针毂座18之间的组合凹槽和凸出部(未示出)中，以固定两者之间的相对的角旋转。
[0038]在一个示例性实施例中，一对沿直径相对的槽28形成于导管毂座14的内壁表面22中。槽28形成为导管毂座的内壁表面22中的凹口，且其各个具有测量为从近侧螺纹30到邻近截头圆锥鼻部分34的远侧肩部32测量的导管毂座的长度的约20％至约85％的长度。槽28可通过已知的注射模制技术形成。
[0039]在一个示例性实施例中，一对凸出部36结合在导管毂座14的内部腔体24中。两个凸出部36优选关于两个槽28对称，且其各包括接触两个槽28的两个端部38。在一个备选实施例中，两个端部38可与两个槽28隔开，且各个凸出部36可以是凹口而非隆起的凸起。因此，在一个优选实施例中，导管毂座的内部腔体24在两个凸出部或凸起36处具有从一个凸起到另一个凸起测量的直径(称为凸起直径)，该直径小于从邻近两个凸起的点40测量的导管毂座14的内部腔体的直径(被称为孔径)。同样在两个凸出部或凸起36处，导管毂座14的内部腔体24具有从一个槽28到另一个槽28测量的直径(称为平均槽直径)，其大于凸起直径和孔径40。
[0040]图2是沿横向平面得到的且针16和针毂座18从其中移除的图1的导管毂座14的截面侧视图。虽然显示了槽28对毂座14的相对位置和凸起36对槽28的相对位置，但是它们可各自朝向近侧开口42而朝近侧改变，或者朝鼻部分34朝远侧及相对于彼此而改变，或者可相对于针斜面72旋转，而不偏离本发明的精神和范围。
[0041]现参看图3，显示了根据本发明的多方面提供的安全IV导管组件的局部截面侧视图，其大体标示为44。在一个示例性实施例中，导管组件44包括止血阀46、阀开启器48和布置在图1的导管毂座14的内部腔体24内部的尖端保护器50。尖端保护器50可与授予Woehr等人的美国专利No.6,616,630中所显示和描述的许多尖端保护器其中之一相同，该专利的内容通过引用而以类似于整体地阐述的方式清楚地结合在本文中。通过使尖端保护器沿针尖72的方向朝远侧运动，直到位于两个臂76和两个指状物或远侧壁78(仅显示了一个)之间的肘部分74(仅显示了一个)朝导管毂座内部的凸出部36的远侧运动，来将尖端保护器50装于内部腔体24内。备选地，可代替两个凸起而结合两个凹陷，以便与两个肘部分74进行交互。
[0042]止血阀46可由热塑性弹性体(TPE)制成，例如聚异戊二烯或硅橡胶，且止血阀46一般而言包括边缘部分52和顶部54，顶部54具有包括多条狭缝(例如类似于三角星的三条狭缝或单条狭缝)的切口56，以便在切口偏转时使其扩张。止血阀46可普遍地在商业上获得，且其是相关领域中众所周知的构件。根据本发明的多方面，多个凸起、伸长的隆起线或突起可结合在边缘部分52的外周边周围，以便为了回血的目的而确保阀边缘52和导管毂座的内表面22之间的充足的空气流动。在本发明的其它方面中，切口56设有足够的间隙，以便为了回血的目的而允许空气运动。在后一种备选实施例中，优选在外边缘部分和导管毂座的内表面22之间有气密密封。
[0043]阀开启器48包括促动端58和一对腿60。在一个示例性实施例中，促动端58包括构造成以便抵靠阀46的顶部54凸出的截头圆锥形远侧端部，如以下参看图5所进一步描述。根据本发明的多方面，促动端58包括一个或多个波浪形表面或倒钩62，以与切口56和止血阀上的多条狭缝进行配合接合。
[0044]在一个示例性实施例中，阀开启器48由硬塑性材料形成，其可以是聚碳酸酯材料、多氧化亚甲基(polyoximethylene)材料等。两个腿60形成为使得它们相对于针轴16径向地向外展开。在本发明的一个具体方面中，两个腿60与两个槽28对齐，且与该两个槽对准。阀开启器48的长度和几何形状使得鼻部分58邻接阀46的边缘部分52，且使得阀施加推动两个腿60的两个近侧端部64来抵靠各个相应的槽28的近侧凸缘66的反作用力(参见例如图9D)。因此边缘部分52处于由抵靠着边缘部分而推压的阀开启器48的鼻部分58导致的略微压缩的状态。或者，在准备好可用的位置中，鼻部分58可与阀46隔开且不接触阀46(图3)。
[0045]两个腿60优选地在没有径向压缩的情况下与两个槽28对准。换句话讲，各个腿60的最径向末端68没有靠着相应的槽28的壁表面70偏置。然而，可实践略微的径向压缩，而不偏离本发明的精神和范围。
[0046]现参看图4，显示了图3的安全IV导管组件，其中针16、尖端保护器50和针毂座18被移除。在实践中，这表示了在成功的导管插入术之后的导管的位置。如Woehr等人的专利’630中所公开的，当在导管插入后抽回针16时，尖端保护器50与针一起被抽回，且保持与针一起，以阻挡针尖72。在本发明的某些方面中，褶皱、凸起或夹扣接合部分73用于接合尖端保护器50上的开口，以将该尖端保护器固定在针上。Kevin Woehr的名称为Needle Assembly andComponents Thereof(针组件及其构件)、序列号为No.11/496,769的美国专利申请公开了包括用于包围针尖的侧壁的尖端保护器，其可与根据本发明的多方面提供的导管组件一起使用。’769申请的内容通过引用而清楚地结合在本文中。在本发明的其它方面中，尖端保护器50结合了翻转以夹紧针的开口。Kevin Woehr的美国专利No.6,709,419，Pat Latona的名称为Protective Needle Clips(保护针夹)、序列号为No.10/677,810的专利申请，以及Matthew Kohler的名称为ProtectiveClips(保护夹)、序列号为No.10/954,041的专利申请中公开了进行翻转以夹紧针的示例性尖端保护器。以上引用中的各个的内容通过引用而清楚地结合在本文中。
[0047]如图4所示，当阀46的顶部部分54不再被针偏转时缩回，且切口56闭合以形成密封。因此，来自导管管体12的方向的血液流动停止。虽然没有描绘，但是阀46的外周边塞入内部腔体中，且阀处于干涉配合引起的压缩下。当血液流动已经停止时，医护人员可从容地将IV套件luer连接器连接到导管毂座14上，用胶带将导管毂座固定在患者上，且处理用过的针，而不会通过导管毂座泄漏过多的血液。或者，阀可提供半渗透性的密封，其给予医护人员充足的时间来在血液将于近侧端部42处离开导管毂座14之前进行所需的连接、固定和对用过的针的处理。
[0048]假定毂座14的开口42限定了平面83，在一个示例性实施例中，两个近侧端部64处的两个腿60的端面80定位成与平面83成一定的角度。两个腿60还应当在刚好邻近两个近侧端部64的位置处，朝导管毂座14的公称内径(即孔径40)径向地向内凸出。如以下参看图5进一步讨论，该凸出在阀开启器48的各个近侧端部64上提供了接触表面，以便由IV套件Luer连接器推动。在一个备选实施例中，端面大体平行于由开口42限定的平面83。
[0049]图5A描绘了被推入导管毂座14的开口42中的IV套件Luer连接器86。当朝远侧向前推压连接器86时，其远侧端部88邻接密封开启器48的两个端面80，且使开启器48向前朝远侧前进。开启器48又运动到密封的顶部区域54中，且迫使切口56偏转。阀开启器48的促动端58上的组合摩擦和倒钩62允许阀开启器48和促动端58保持接合。阀46保持开启，且在导管管体12和导管毂座14的内部腔体24之间提供了流体连通。药物、IV溶液或其它流体现在可通过连接器86和导管12引入。如果IV套件luer连接器86随后从导管毂座14中抽回，则阀46将保持开启，并且因此可能存在血液泄漏。或者，促动端58没有像图5B中显示的那样结合倒钩62，从而允许阀的顶部部分54与促动端58分开。这就允许阀开启器48通过弹性顶部部分的动作而朝近侧运动，同时允许切口重新密封自己。
[0050]图6是针毂座90的截面侧视图，该针毂座90具有附连在其端部处的针92和覆盖针尖96的尖端保护器94。如本领域所知，回血塞(未示出)通常放置在针毂座90的近侧端部中。尖端保护器94与序列号为No.11/496,769的申请中所显示和描述的一样，该申请在前面通过引用而结合在本文中。如’769申请中所公开的，尖端保护器94包括由第二保护器主体100包围的第一保护器主体98。第一保护器主体包括短臂102和长臂104，其两者具有至少部分地延伸到针92的中心线的一侧的部分。第二保护器主体100(图7)部分地包围第一保护器主体，且包括偏转板106、具有开口110的前壁108和两个侧壁112(仅显示了一个)。当尖端保护器94在针尖(图6)上处于保护位置时，针尖被多个壁包围。
[0051]在一个示例性实施例中，图6的组合针毂座90、针92和尖端保护器94可与图4中所示的导管一起使用。毂座14上的凸出部36将相对于尖端保护器94的长臂104的顶点115布置在近侧，以使尖端保护器94保持在导管毂座14中。或者，可省略凸出部36，且臂102和偏转板106弹性地接合内壁表面22，以使尖端保护器94保持到导管毂座上。
[0052]一般而言，当在成功的导管插入术之后从导管管体中抽回针时，残余的血液可沉积在针轴上。在抽回的针上的看见和存在血液是不合需要的且可能会传染。因此，根据本发明的多方面，提供了擦拭器，以便在从导管中抽回针时擦拭针。图8A、9A、9B和9C是根据本发明的多方面提供的四种不同的擦拭器176、116、118和120的俯视图。如以下参看图8B和9D所进一步讨论，擦拭器构造成以便附连到阀开启器或导管毂座上，以便在从导管管体中抽回针时从针的表面刮去或擦去流体。
[0053]图8A显示了由液体不可渗透的薄膜(例如吹塑PE薄膜)制成的擦拭器176，其包括具有两个切口178的大体为圆形的构造。切口178大小设置成且成形为以便允许装配在阀开启器上，且切口178沿着擦拭器的周边而结合。因此，切口形状和擦拭器的整体构造可取决于阀开启器的安装表面而改变。在一个示例性实施例中，擦拭器176具有构造成用于在组装期间被针刺穿的实心中心部分(即无中心开口)，如以下所进一步讨论的。
[0054]图8B是根据本发明的多方面提供的阀开启器180的透视图。在一个示例性实施例中，阀开启器包括促动端182和连接到促动端上且朝促动端的近侧延伸的两个腿184。像图3所示的阀开启器48一样，促动端182包括截头圆锥构造，且结合了倒钩(图8B中未显示)和用于容纳针的通道。在本发明的一个具体方面中，通道在形状上为漏斗状。虽然显示了两个腿184平行于且偏离由通道的中心限定的轴线而延伸，但是两个腿184可在它们朝近侧延伸的时候径向地向外成角度。两个腿还可结合略微的弧形或弯曲，例如图3中所示的那样。
[0055]在一个示例性实施例中，提供了促动端上的面向近侧的壁表面186，且其用作用于擦拭器的安装表面。图8A的擦拭器176可在切口178与两个腿184对齐的状态下附连到安装表面186上。擦拭器可焊接在安装表面上，或用适当的粘结剂(例如氰基丙烯酸盐粘合剂或UV固化粘结剂)粘在安装表面上。在实践中，阀开启器180和擦拭器176可像图8C中所示的那样安装，且当插入针16时，针尖72穿透擦拭器，且擦拭器随后为针提供擦拭功能。当擦拭器176被针尖72穿透时，针16将使擦拭器打开及扩张，使针与擦拭器176处于紧密接触的关系。因此，当针16的上游部分146(即擦拭器的上游)暴露于来自回血的血液且随后向近侧(即向图8C的右边)抽回以移除针16时，擦拭器176和针16之间的紧密接触关系允许擦拭器在针被抽回时从针上擦去血液沉积。因此，当针完全从阀开启器中抽回时，针将看起来很干净，或者至少对大部分来说在视觉上是看不到血液的，而且包围针尖的尖端保护器将有可能保持视觉上看不到血液。
[0056]图9A显示了擦拭器116，其具有包围塑料内层124(例如聚乙烯(PE)吹塑薄膜层)的由第一擦拭器材料122制成的大体圆形构造(可以是多微孔塑料薄膜过滤器)。外擦拭器材料122优选是空气可渗透的，以允许回血。薄膜可由PP(聚丙烯)或PA(聚酰胺或
Figure A20078004898000161
)纺粘纤维(spun bound fiber)制成，例如本领域中从回血塞中已知的那些。在一个优选实施例中，内层124是构造成用于在将组合针毂座和针装配在导管毂座(例如具有附连到阀开启器上的擦拭器的图3中所示的那个)上时被针刺穿的塑料薄膜。擦拭器应当足够薄，以便在针尖通过其中时不损坏针尖。内层和外层可以焊接到彼此上。
[0057]在一个示例性实施例中，除了预成形开口126之外，图9B所示的擦拭器118与图9A所示的擦拭器116相同。开口126优选地大小设置成与针直径相同。换句话讲，开口大小设置成在针的外径周围具有零间隙。更优选地，开口126大小设置成与导管末端的内径相同，其略微小于针的外径。
[0058]图9C显示了根据本发明的多方面提供的又一个擦拭器实施例120。在一个示例性实施例中，擦拭器包括具有开口126的单个薄膜层128，其具有与导管末端的内径相同的直径大小。多个微孔形成于薄膜层128中，以便于通气。孔各自大小设置成约3μm(微米)至约8μm。薄膜可由PE或纺粘PA或PP制成。
[0059]图9D是根据本发明的多方面提供的一个备选的安全IV导管组件的截面侧视图，其大体标示为188。导管组件188与图3的导管组件44相似，且包括导管管体12和毂座14、针16和针毂座18、尖端保护器50、阀开启器48和阀46。然而，在一个备选的安全IV导管组件188中，空气可渗透的且流体不可渗透的擦拭器190结合在阀46的远侧。在一个示例性实施例中，擦拭器190可以是图9A、9B或9C中所示的擦拭器116、118或120其中之一，且可附连到管体衬套192上，以便将导管管体12保持在导管毂座14上。管衬套192优选地由热塑性材料制成，以有利于例如通过粘结或焊接使擦拭器90附连在其上。在一个备选实施例中(未示出)，可在导管毂座14的内部腔体内提供肩部或底座，以便容纳擦拭器190。
[0060]图10A是针130穿过阀开启器132(具有附连在其上的擦拭器134)而凸出的局部透视图。阀开启器132与参看图3-5所显示和描述的阀开启器相似。图10A以及以下进一步讨论的图10B-12可被视为安全导管组件，例如图3的组件，其为了清楚和出于仅讨论擦拭器的功能的目的而没有显示导管毂座、针毂座或尖端保护器。因此，应当理解，图10A所示的构件以及图10B-12中的那些适于以与参看图1-5所述的那些相同的方式与导管毂座、针毂座和尖端保护器一起使用。此外，尖端保护器不限于所示的那些，而是还包括通过引用而清楚地结合在本文中的那些。
[0061]在一个示例性实施例中，阀开启器132包括朝截头圆锥形促动端138的近侧延伸的两个腿136。虽然没有显示，但是促动端138可包括用于与止血阀进行夹紧接合的波浪形表面或倒钩。促动端138包括大体为平面的面向近侧的表面140和用于接收针130的通道或内腔142。两个腿与针130径向地隔开，且在其之间具有间隙143，以容纳尖端保护器。
[0062]图10B是图10A的阀开启器132的局部透视局部截面旋转和放大视图。阀开启器显示为带有在促动端138的凹陷部分内具有环件或圆柱件的擦拭器134。擦拭器134可嵌入模制在开启器132中。突出物144是留在擦拭环件和腔体门之间的材料。或者，擦拭器可与促动端138是一体的。擦拭器134包括具有略微大于针130外径的第一直径的通道152，以及具有第二直径的唇缘154，该第二直径优选为导管管体(针130构造成以便布置在其中)的导管末端的内径大小。如以上参看图8C和9D所讨论的，当朝近侧抽回针130时，沿着针的上游端部(远侧)146的血液沉积被擦拭器150擦去。
[0063]图10B显示了具有单个腿136的阀开启器132。然而，具有其间有间隙的两个腿的阀开启器是更优选的。两个腿136之间的间隙构造成以便容纳尖端保护器50，例如图3和9D中所显示的那样。
[0064]图11是根据本发明的多方面提供的一个备选阀开启器156的局部透视局部截面侧视图。阀开启器156显示为具有穿过促动端138而凸出的针130。在所显示的实施例中，结合了井或凹陷区域158，以便容纳O形环160形式的擦拭器，该O形环160可由弹性体或TPE材料制成。O形环160可滑入井158及抵靠着O形环而受推压的保持环162中，以将O形环保持在其中。保持环162通过使用简单的干涉配合而固定在井158上。在一个备选实施例中，保持环162焊接在阀开启器上。
[0065]如前所述，O形环160优选与针130有接触关系，从而当向近侧(向图11的右边)远离阀开启器156而收回针时，O形环可擦拭该针。显示了开启器156在两个腿136之间具有间隙，以便容纳尖端保护器(未示出)。开启器156和针130构造成以便以与图3所示的开启器和针相同的方式与导管毂座一起使用。
[0066]图12是根据本发明的多方面提供的又一个备选阀开启器166的局部截面透视图。在所显示的实施例中，环形凹槽168结合在井158中，以便容纳弹性体的或TPE擦拭器170。擦拭器170类似于像炸面圈一样的平整的O形环，但实际上其还可以是O形环。这种构造使得普通的阀开启器能在各种针外径和O形环内径的情况下使用。擦拭器170在没有单独的保持环(例如图11中的环件162)的情况下保持在井158内。擦拭器170可在组装期间搭扣配合在凹槽168中。
[0067]图13是根据本发明的多方面提供的又一个备选导管组件的截面侧视图，其大体标示为200。导管组件200结合了与图8C和9D所示的组件相似的构件，其包括附连到导管毂座14上的导管管体12、附连到针毂座18上的针16、止血阀46、包括布置在导管毂座14中的对应槽28中的一对腿60(仅显示了一个)的阀开启器48、附连到导管毂座14和阀开启器48中任何一个上的擦拭器(未示出)，以及用于阻挡针尖72的尖端保护器202。然而，不是将尖端保护器202放置在由阀开启器48中的两个腿60限定的间隙中，而是结合了第三壳体204，以便容纳尖端保护器。另外，擦拭器(未示出)可在尖端保护器202的远侧附连到第三壳体204上，以便在插入导管之后抽回针时擦拭针。
[0068]在一个示例性实施例中，第三壳体204结合了附连到闭合的壳体部分208上的后板或面板206，以便关闭闭合的壳体部分208上的开口207。闭合的壳体部分208上的开口207允许尖端保护器202在组装期间放置在其中。后板206可通过使用粘结、焊接或棘爪附连到壳体部分208上。或者，闭合的壳体部分208可在与后板206正交的一侧上结合开口。
[0069]第三壳体204结合了各包括钩部212的一对臂210。两个钩部212构造成以便接合两个凸起36，以将第三壳体204保持在处于准备好可用的位置上的导管毂座14上。两个臂210优选是柔性的，以提供与两个凸起36相反的夹紧力，该夹紧力高于通过尖端保护器202、止血阀46和导管12抽回针的摩擦力。或者，两个臂210可径向地向外偏置，以增大夹紧力。另外，两个臂可抵靠着针轴向内偏置，以便在朝臂210的近侧抽回针之后减小夹紧力。
[0070]在成功插入导管之后，以与以上所述相同的方式(即向图13和14的右边)朝近侧远离导管管体12而拉回针16。当针尖72朝尖端保护器202的远侧壁214向近侧运动时，尖端保护器202接合针16，且针16的进一步的朝近侧的运动使尖端保护器202在第三壳体204的后板206上牵拉，这然后使两个钩部212与两个凸起36脱离。因此，两个钩部212和两个凸起36之间的夹紧力应小于尖端保护器202和针16之间的夹紧力。
[0071]现在参看图14，尖端保护器202包括近侧壁216、臂220以及远侧壁214；近侧壁216包括开口218、臂220包括开口222(图13)，远侧壁214位于臂220的远侧端部处。近侧壁216和臂220在其之间限定了角□。在准备好可用的位置上(未示出)，尖端保护器202的端部边缘224抵靠着针16的一侧偏置，且角□具有就绪角度值□就 绪。当在激活的位置上(图13和14)时，角□增大到受保护的角度值□受 保护，其大于就绪角度值□就绪。当出现这种情况时，臂进一步倾斜，且臂上的开口222夹紧针，以便不用褶皱来接合针。
[0072]图15显示了阀开启器193的另外的实施例的纵剖面。促动端194与两个腿195连接，图15中显示了两腿其中之一。在用于容纳针的通道196中，提供了环形唇缘197形式的擦拭器，其中这个环形唇缘197沿远侧方向渐缩。这个唇缘197可通过注射模制与促动端194集成。提供由不同于促动端194的适当材料制成的环形唇缘197也是可行的，其中环形唇缘197可通过双构件注射模制与促动端连接。通道196在近侧上具有以下部分：具有60°的较大渐缩的部分，以及其后的具有4°渐缩的部分。
[0073]虽然已经特别地描述和说明了有限的导管组件实施例及其构件，但是对本领域技术人员而言，许多修改、组合和变型将显而易见。例如，可以修改针毂座和导管毂座的长度、大小、颜色和外表，可以使用除了特别地结合在本文中的那些之外的尖端保护器，而且除了阀开启器上的两个一样长的腿之外，可以使用具有不同长度的单个腿或两个腿。另外，除了将尖端保护器放置在导管毂座中以阻挡针尖，还可以结合第三壳体来容纳尖端保护器，且第三壳体可布置在导管毂座和针毂座之间，如2002年3月29日提交的名称为“SAFETY SPRINGCATHETER INTRODUCER ASSEMBLY(安全弹簧导管导引组件)”、序列号为No.10/109,797的美国申请中所描述，该申请的内容以类似于完整地阐述的方式通过引用而清楚地结合在本文中。第三壳体和尖端保护器还可构造成名称为“NEEDLE ASSEMBLY WITHPROTECTIVE ELEMENT(具有保护元件的针组件)”、序列号为No.10/468,923的美国申请，以及美国专利No.7,125,397中所描述的那样，它们的内容通过引用而清楚地结合在本文中。此外，理解和构思的是，只要功能是兼容的，可以为了包括另一个阀实施例而采用针对一个阀实施例、擦拭器、阀开启器或尖端保护器而特别地讨论的特征。例如，虽然没有清楚地讨论整体的组合，但图6的针和尖端保护器、图10A的阀开启器和擦拭器以及图8C的止血阀可与图2的导管毂座一起使用。因此，将理解的是，根据本发明的原理构造的导管组件及其构件可以以不同于本文特别地描述的方式来实施。本发明还限定于所附的权利要求书。

Claims (30)

1.一种导管组件，其包括：
包括壳体的第一毂座，所述壳体包括外表面和限定了内部腔体的内表面；
管体，其附连到所述第一毂座上且朝所述第一毂座的远侧延伸；
包括壳体的第二毂座，所述壳体包括外表面和限定了内部腔体的内表面；
具有针尖的针，其附连到所述第二毂座上且朝所述第二毂座的远侧凸出并进入所述管体中；
阀，其包括顶面、从其上悬出的边缘、以及所述顶面上的使所述针通过其而凸出的开口；
包括促动端的阀开启器，至少一条腿自所述促动端朝近侧延伸，以及
包括周边的擦拭器，所述周边限定了开口且所述针与所述周边接触，以用于在远离所述管体而拉回所述针时擦拭所述针。
2.根据权利要求1所述的导管组件，其特征在于，所述导管组件进一步包括布置在所述第一毂座的内部腔体中的尖端保护器。
3.根据权利要求1所述的导管组件，其特征在于，所述擦拭器附连到所述阀开启器上。
4.根据权利要求1所述的导管组件，其特征在于，所述擦拭器直接地或间接地附连到所述第一毂座上。
5.根据权利要求1所述的导管组件，其特征在于，所述擦拭器是液体不可渗透的。
6.根据权利要求1所述的导管组件，其特征在于，所述针包括夹扣接合部分。
7.根据权利要求2所述的导管组件，其特征在于，所述尖端保护器包括相交的两个臂。
8.根据权利要求2所述的导管组件，其特征在于，所述尖端保护器包括由第二保护器主体包围的第一保护器主体。
9.根据权利要求2所述的导管组件，其特征在于，所述尖端保护器包括至少部分地延伸到所述针的一侧的两个臂。
10.根据权利要求1所述的导管组件，其特征在于，所述第一毂座是导管毂座并且包括内部凸起。
11.根据权利要求1所述的导管组件，其特征在于，所述第二毂座为针毂座。
12.根据权利要求1所述的导管组件，其特征在于，所述导管组件进一步包括形成于所述第一毂座的内表面上的至少一个槽。
13.根据权利要求1所述的导管组件，其特征在于，所述至少一个腿布置在所述至少一个槽内。
14.根据权利要求1所述的导管组件，其特征在于，所述擦拭器为O形环。
15.一种导管组件，包括：
a)包括壳体的导管毂座，所述壳体包括外表面和限定了内部腔体的内表面；
b)附连到所述导管毂座上且朝所述导管毂座的远侧延伸的导管管体；
c)包括壳体的针毂座；
d)具有针尖的针，所述针附连到所述针毂座上且朝所述针毂座的远侧凸出并进入所述导管管体中；
e)布置在所述导管毂座的内部腔体中的用于限制血液回流的阀；
f)布置在所述阀的近侧的用于打开所述阀的阀开启器；以及
g)布置成邻近所述阀开启器的用于阻挡所述针尖的尖端保护器，其中所述尖端保护器包括：
(1)具有内表面的尖端保护器壳体；
(2)自所述尖端保护器壳体的远侧壁延伸、朝向所述导管毂座的内表面偏置的第一臂；
(3)自所述尖端保护器壳体的近侧壁延伸、朝向所述导管毂座的内表面偏置的第二臂；以及
(4)自所述尖端保护器壳体的近侧壁延伸、抵靠所述针的侧面偏置的第三臂。
16.根据权利要求15所述的导管组件，其特征在于，所述导管组件进一步包括用于在远离所述导管管体而拉回所述针时擦拭所述针的擦拭器。
17.根据权利要求16所述的导管组件，其特征在于，所述擦拭器附连到所述阀开启器上。
18.根据权利要求16所述的导管组件，其特征在于，所述擦拭器或者直接地或者间接地附连到所述导管毂座上。
19.根据权利要求15所述的导管组件，其特征在于，所述导管组件进一步在所述针上包括褶皱。
20.根据权利要求15所述的导管组件，其特征在于，所述阀开启器包括用于开启所述阀的促动端。
21.根据权利要求20所述的导管组件，其特征在于，所述阀开启器包括朝所述促动端的近侧延伸的至少一个腿。
22.根据权利要求21所述的导管组件，其特征在于，所述导管毂座包括至少一个槽，并且其中所述至少一个腿布置在所述至少一个槽内。
23.一种导管组件，包括：
包括限定了内部腔体的壳体且具有朝其远侧延伸的导管管体的导管毂座；
包括限定了内部腔体的壳体且具有针的针毂座，所述针具有朝其远侧延伸的针尖；所述针凸入所述导管管体中；
布置在所述导管毂座的内部腔体内的具有开口的止血阀；
布置成邻近所述止血阀且包括促动端的阀开启器，所述促动端包括锥形部分和限定了朝其近侧延伸的间隙的一对腿；
使所述针穿过其中以用于在从所述导管管体中拉回所述针时擦拭所述针的擦拭器；以及
其中，包括臂和壁的尖端保护器，所述壁包括开口，且所述尖端保护器布置在由所述两个腿限定的间隙中。
24.根据权利要求23所述的导管组件，其特征在于，所述擦拭器附连到所述阀开启器上。
25.根据权利要求23所述的导管组件，其特征在于，所述擦拭器直接地或间接地附连到所述导管毂座上。
26.根据权利要求23所述的导管组件，其特征在于，所述壁构造成以便从第一大体向上的位置倾斜到倾斜位置，以便所述开口夹紧所述针。
27.根据权利要求23所述的导管组件，其特征在于，所述针包括褶皱。
28.根据权利要求23所述的导管组件，其特征在于，所述擦拭器为O形环。
29.根据权利要求23所述的导管组件，其特征在于，所述尖端保护器包括由第二保护器主体包围的第一保护器主体。
30.根据权利要求23所述的导管组件，其特征在于，所述阀开启器与处于准备好可用的位置的所述止血阀以接合的方式接触。
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