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CN1946451A - 静脉插管的阀式护套导入器 - Google Patents

静脉插管的阀式护套导入器 Download PDF

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CN1946451A
CN1946451A CNA2005800133905A CN200580013390A CN1946451A CN 1946451 A CN1946451 A CN 1946451A CN A2005800133905 A CNA2005800133905 A CN A2005800133905A CN 200580013390 A CN200580013390 A CN 200580013390A CN 1946451 A CN1946451 A CN 1946451A
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valve
handle
command
sheath
slit
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M·A·克里斯滕森
S·M·史密斯
W·商
J·D·比尔
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CR Bard Inc
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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
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
    • A61M39/0693—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof including means for seal penetration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/7722—Line condition change responsive valves
    • Y10T137/7837—Direct response valves [i.e., check valve type]
    • Y10T137/7879—Resilient material valve
    • Y10T137/788—Having expansible port
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T137/00—Fluid handling
    • Y10T137/7722—Line condition change responsive valves
    • Y10T137/7837—Direct response valves [i.e., check valve type]
    • Y10T137/7879—Resilient material valve
    • Y10T137/788—Having expansible port
    • Y10T137/7882—Having exit lip
    • Y10T137/7885—Multiple slit
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49405—Valve or choke making
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49405—Valve or choke making
    • Y10T29/49412—Valve or choke making with assembly, disassembly or composite article making
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T29/00—Metal working
    • Y10T29/49—Method of mechanical manufacture
    • Y10T29/49826—Assembling or joining

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Hematology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种静脉插管的阀式护套导入器(20)，包括阀(100)、护套(22)、把手(30)和盖子(40)。该阀构造成可允许医疗器械通过该护套导入器安全导入和移出。该阀可以具有一个或多个锚定元件(102、104)以及增厚的中心部(106)，狭缝(110)贯穿该中心部形成。该中心部可以具有一个或多个凹面(304)，而该狭缝可以相对该阀的顶面成一定角度。该盖子连接于该把手，以压缩其间的阀的一部分。

Description

静脉插管的阀式护套导入器
相关申请
本申请主张在2004年4月30日提交的美国临时申请No.60/566,896的优先权，其内容通过引用整体地结合于本文中。
背景技术
导入器装置一般用于将诸如静脉导管的医疗卫生器材插入患者体内。通常，这种导入器装置包括剥式护套和轮轴/把手部件，该轮轴/把手部件用于协同扩张器件进入患者血管，随后插入针和导引线。特别地，将导管导入血管的方法包括切入法和穿刺法。穿刺法包括首先将针穿过患者皮肤插入待插入导管的血管，将导引线穿过针插入血管，将针从导引线移出并将扩张器与导入器护套沿着导引线插入血管，同时将扩张器与导引线从导入器护套移出，将导管通过导入器护套插入到靶血管内的位置。随着导管的插入，导入器护套通常设计成可以从导管剥去，而无对导管在血管内定位的影响。这种导入器护套及部件在例如于1988年9月20日公告且以Groshong为发明人的美国专利No.4,772,266以及于1981年12月21日公告且以Osborne为发明人的美国专利No.4,306,562中均有说明，其内容各通过引用结合于本文中。
然而，上述方法的问题包括：1)在扩张器和导引线从护套移出时会发生通过护套的失血，以及，2)导入器护套为空气导入患者的血管提供了管道，这会造成气栓。而且，气栓的风险与留置护套的直径成正比地增加，亦即惯用于放置大直径导管的大直径护套会增加这种风险。因而，已有多种解决方案提出，其包括在导入器护套的近端内结合一个阀，这将允许导引线和扩张器通过而同时防止失血或空气通过护套的导入。这种所提出的解决方案可见于例如于1992年6月30日公告且以Lee为发明人的美国专利No.5,125,904，于1995年3月14日公告且以Walker等人为发明人的美国专利No.5,397,311以及于2000年7月4日公告且以Heck为发明人的美国专利No.6,083,207中，其内容各通过引用结合于本文中。
上述及类似导向的专利均主要与提供弹性的阀结构相关，该阀结构为动脉插管方法于存在重要的正血压的情况下提供止血并防止失血或渗血。另一方面，对于静脉插管，血压很低且可以包括负压，亦即尽管防止失血是次要的顾虑，但防止气栓是最为关键的考虑。因而，为静脉插管的特别应用设计一种阀式护套导入器存在必要。
发明内容
因此，本发明涉及一种用于静脉插管的阀式护套导入器。在本发明的一个实施例中，在该导入器中的阀包括具有中心狭缝的薄盘，并包括诸如相对的锚、增厚的中心部以及机械或者其它的装置的特征。该相对的锚允许当医疗卫生器材通过该盘插入时该盘的伸长。自动密封狭缝通过该增厚的中心部进行定位，这促进在移出医疗卫生器材时的最佳的重新密封。该机械或者其它的装置分离该盘的同时从插入的医疗卫生器材破开并分离护套把手。在一个实施例中，该增厚的中心部或者岛状部具有凹面。该阀的一些实施例包括狭缝或者与该中心狭缝对准的凹槽以便当该护套与把手从插入的医疗卫生器材移开时该阀的分离。
在本发明的另一个实施例中，用于将医疗卫生器材插入主体的器械包括具有护套主体和把手的护套、阀以及连接于该把手的盖子。该把手包括至少一个接收部。该阀具有通过其中心部的狭缝和构造成用于插入该把手的接收部的至少一个锚定元件，该锚定元件沿着该阀的边缘进行定位。该阀的至少一部分压缩在盖子与把手之间。在另一个实施例中，细线圈过定位在该阀中的中心狭缝，以便当该把手从通过该阀式护套导入器插入的医疗卫生器材被分开和移开时，该线将阀切割成两个部分。
在该阀式护套导入器的一个方面，该阀设计成当移出诸如扩张器的器械时可提供最佳的密封。该最佳的密封由于该阀的诸如中心部或者岛状部以及一个或多个锚定元件的构造以及该阀紧固在把手和盖子之间的方式而形成。因而，在器械从该导入器护套移出时，当该器械通过其插入时被伸长的该阀主体朝着该把手回弹，但由于该盖子和该把手所施加的压力而不能恢复其初始位置。结果是该阀的群聚效应或者鸭嘴效应提供了预期的密封。
通过对本发明的更详细说明与附图的结合，本发明的这些以及其它实施例、特征与优点都变得极为明显。
附图说明
图1显示了插有扩张器的阀式护套导入器的一个实施例的侧视图。
图2显示了图1中的单独(isolation)的护套导入器的侧视图。
图3显示了图2中的护套导入器的把手的顶视图。
图4显示了阀式护套导入器的阀的一个实施例的仰视图。
图5显示了图4中的阀的侧视图。
图6A与图6B显示了图4中的阀的横截面图。
图7显示了阀式护套导入器的阀的另一个实施例的仰视图。
图8显示了阀式护套导入器的阀的又一个实施例的仰视图。
图9A至图9D显示了阀式护套导入器的阀的一个实施例的有益特征。
图10示出了组装前的阀式护套导入器的另一个实施例的阀、把手以及盖子。
图11示出了图10中的单独的阀与把手。
图12是图10中的盖子、把手和阀的横截面组装图。
图13是图12中的盖子、把手和阀的进一步的横截面图。
图14是具有岛状部的阀的另一个实施例，该岛状部具有凹面。
图15是图14中的阀的横截面图。
具体实施方式
以下的详细说明将参考附图更充分地进行说明，其中相同的参考标号在图中用以标识近似的元件。这些不成比例的附图示出了选择出的实施例而不是为了限制本发明的范围。该详细说明以实施例的方式而非以限制的方式显示了本发明的原理。该说明将使本领域内的技术人员能够明显地制造及使用本发明，并说明了若干实施例、修改、变形、代替及使用，包括了相信是实施本发明的最佳方式。
本发明包括尤其是用于静脉插管方法中的阀和阀式护套导入器。然而，应该明白尽管此处说明的设计是用于这种应用，但它们同样可以适用于各种其它应用(例如，动脉插管，起搏器电极线的导入等等)并因此不应如此被限制。进一步地，尽管护套导入器和护套导入器部件为了阀的收容与实施的示范性的目的进行了说明，应该明白护套导入器和护套导入器部件的许多不同的构造和类型将同样适用于与本发明的阀一起使用，并因此决不能用于限制此处说明的阀的范围。另外，如同在该说明书和附加的权利要求中所用的，单数形式的“一”和“该”包括多个指示物，除非上下文清楚地另外指出。因而，例如，术语“一个狭缝”意在指示一个单一狭缝或者多于一个的狭缝。
现在参照图1和图2，其显示了根据一个实施例的阀式护套导入器部件10，该阀式护套导入器部件10包括阀式护套导入器20和扩张器50。阀式护套导入器部件10以具有完全插入并锁定于阀式护套导入器20的扩张器50的插入构造进行显示。阀式护套导入器20包括护套主体22、把手30、盖子40和内阀100(图4)。在此实施例中，把手30具有被两个狭槽36分开、大约180度分开地定位的第一侧边32和第二侧边34。护套主体22具有便于插入血管的锥形远端24。在一个实施例中，护套主体22由聚四氟乙烯(PTFE)制成，而把手30和盖子40由K-树脂(K-Resin)(苯乙烯-丁二烯共聚合物)制成。在另一个实施例中，把手30和盖子40由冰晶石(Cryolite)(聚甲基丙烯酸甲酯)制成。当然，其它的材料，包括其它的聚合物材料(例如，聚碳酸酯、热塑性塑料等等)也可用于护套主体、把手和盖子，这对本领域内的技术人员是明显的。
在阀式护套导入器20的示范性的制造方法中，把手30嵌入成型在护套主体22的近端26外。成型之后，阀100设置在把手30上部，而盖子40在处于作用力下的阀100上连接于把手30(例如，通过超声波焊接、粘合剂、螺钉等等)。在一个示范性的制造方法中，固定方法是超声波焊接，其中护套主体22和把手30设置在超声波焊接机内且盖子40在阀100放置在把手30内后压在把手30上。超声波焊接机通过盖子40发送振动，使一部分盖子40和把手30结合在一起。在一个实施例中，盖子40在焊接前处于两个部件的形式以便可以提供与狭槽36对准的小间隙。在连接阀100和盖子40前的图3所示的把手30的顶视图中，可以更详细地看到狭槽36以及把手孔39，把手孔39构造成可与阀式护套导入器20的内腔的直径大致相同。另外，可以看到阀接收部38构造成可容纳阀锚102、104(图4)，这将在下面更详细地说明。
再参照图1，扩张器50包括螺旋接头52，其独立于扩张器主体56旋转并构造成用于与盖子40配合以将扩张器50锁定于阀式护套导入器20。主体56具有大致等于阀式护套导入器20内腔的直径的直径，并还具有提供轻松将阀式护套导入器部件10插入血管的锥形远端58。扩张器50还包括在其近端的接头54以固定在用于诸如清洗目的的装置。还可以在扩张器近端外设置输液套留置盖(injectioncap)(图未示)。
图4至图6B显示了用于结合于阀式护套导入器的阀100的一个实施例。图4是阀100的仰视图，其是薄盘状主体108，包括围绕主体108圆周边缘并布置在其背面的阀锚102、104。阀锚102、104可如图5和图6A所示地自主体108延伸，并对尺寸和形状上进行构造以符合把手30(图3)的阀接收部38，从而保证阀100在器械从其中插入及收回时保持在轴向位置，并且还保证阀100在护套导入器20从插入的器械移出时适当地分开(阀的各边保持在其所被连接的各自的把手的侧边)。
图6A是图4沿着线6A-6A的剖面图，显示了岛状部106相较于相对的锚102、104的相对厚度。如在此实施例中所示，岛状部的厚度稍小于锚的厚度，虽然在其它的实施例中，岛状部厚度等于或者大于锚的厚度。在另外其它的实施例中，锚102、104具有不同的厚度，每一厚度可以大于、小于或者等于岛状部厚度。同样，在图示的实施例中，锚102、104具有圆形边缘116，尽管其它包括具有相对直角的边缘的构造在这里毫无疑问地是可预期的。图6B显示了阀100的另一个实施例，包括刺穿阀100的中间区域的狭缝110A，该狭缝110A以一定角度从阀的顶面通过其底面(例如，到达岛状部106的表面)，该狭缝110A与图6A所示的与阀的顶面大约成的90度是不同的。尽管狭缝110A以大约45度的剖面显示，当然任何其它的相对于阀的顶面的不平行的角度都是可能的，这对本领域内的技术人员应是明显的。
如上所述，锚102、104允许相对于被盖子40紧密连接在把手30内的阀100的定位的紧密度公差。该紧密度公差由阀100在移出已经先行插入其中的器械(例如，扩张器，等等)时产生了关于它的密封的有利反应。特别地，与定位在主体108中心的圆形特征的、自主体108底部沿着锚102、104延伸的岛状部106相呼应，在将器械从护套导入器20移出时产生了一个良好密封，这将在以下结合图9A至图9D进行说明。应该明白尽管如图4所示的阀100具有圆形形状且阀锚102、104具有半圆形形状，各种形状和尺寸在此处均是可能和预期的，以符合它们所连接于其上/其内的把手和接收部的形状与尺寸。
在如图4所示的实施例中，外围狭缝112、114近似等距地在主体108的边缘上并在主体108的相对边上的阀锚102、104之间隔开，这使得阀100易于沿着从狭缝112到狭缝114延伸的线分开。这些狭缝还可以是具有各种形状的凹槽的形式，图7和图8显示了其中的两个(122、124和132、134)。尽管所示的凹槽的形状是三角形和梯形，其它的形状在此处也是可能的并且是预期的，以便阀100的分开。可以被器械通过其插入的中心狭缝110刺穿阀主体108与岛状部106，并且关于阀100的边缘大致中心地定位。尽管仅图示了一个狭缝，在其它的实施例中，两个或者更多的狭缝以不同的图案穿过阀而形成。例如，在一个实施例中，当从顶部或者底部观看时，多个狭缝以类似于星号的图案刺穿阀。正如所述，当阀100设置在把手30中时，阀锚102、104定位在把手30的接收部38内，这将岛状部106放置在把手孔39的开口中。这种对准使得狭缝112，114与把手30的狭槽36对准。
下面的材料和尺寸作为一个实施例的例子进行提供而不能以任何方式作为本发明的限制。在此实施例中的阀100由硅树脂(DowCorning Q7-4840)制成，具有大约0.516英寸的直径，而岛状部106的直径大约是0.260英寸且在岛状部102、104的内边缘之间的距离大约是0.420英寸(锚的宽度因而大约是0.048英寸)。阀100沿着锚102、104的厚度大约是0.090英寸，而阀横过岛状部的厚度大约是0.045英寸，剩余主体因此具有大约0.025英寸的厚度。阀100两边上的锚102、104之间的距离大约是0.160英寸。中心狭缝110具有大约0.204英寸的长度，而外围狭缝112、114具有大约0.050英寸的长度。在其它的实施例中，尺寸依赖于通过阀插入的器械的尺寸。
关于阀的岛状部106，图15和图16显示了它的另一个实施例。图示的阀300包括一个或多个锚302和岛状部306，该岛状部306具有延伸入阀主体308的厚度之内的凹面304和一个狭缝310。图示的狭缝310关于阀的顶面大约成60度定位，然而如以上结合图6A与图6B所述，任何其它的关于阀的顶面的不平行的角度都是可能的。凹面的曲率可以比图示的更大的或者更小，并可以小于、等于在其它的实施例中的阀主体的线条地延伸。凹面的深度还是可变的，其在不同的实施例中改变岛状部的正中央的厚度。如图15所示，岛状部的边缘以及锚是曲线形的，其它的类型的边缘是可能的。关于阀中的岛状部和狭缝或者凹槽的构造的众多的实施例均是预期的。例如，阀可以在沿着其相对的边上的凹槽的岛状部上具有凹面，阀可以在岛状部上具有凹面并在阀的顶部具有相对凹面而无狭缝或者凹槽，阀可以具有凹槽或者狭缝但没有岛状部等等。
图9A至图9C示出了阀100的一边在器械通过其插入(图9B)以及从那里收回(图9C)时关于把手30和盖子40的构造。所提供的虚构的格子用以帮助说明阀100关于把手30和盖子40的运动和定位。然而，应该明白格子只是示范性的而非意在示出实际距离或者精确间隔。在图9A中，阀100在器械通过其插入前紧固在把手和盖子之间。靠近观察阀100显示阀材料150在把手30和盖子40之间的的厚度稍微小于在此区域外(亦即，在把手孔39内)的阀材料160的厚度。这是由于当盖子40如上所述连接于把手30时施加在阀100上的压力。可以看到，在图9A中阀材料150和160的格子线上的标志之间的距离是相同的。
图9B示出了在器械通过其插入时阀100的运动，阀材料160伸长并经历厚度的减小以便其厚度大约等于阀材料150的厚度(然而，在因器械通过阀100插入而伸长时，阀材料160的厚度当然可以大于或者等于阀材料150的厚度)。除了阀的厚度，沿着阀材料160的格子线上的标志之间的距离的增加证明了该伸长的示范。虽然阀材料150在器械通过阀100插入时仍然紧固在盖子40和把手30之阆，材料的伸长确实发生了。这个动作通过格子线显示在图9B中，因为在格子线上的标志之间的距离显示出是增加了。此处应该注意尽管临近锚的材料在器械通过阀100插入时稍微伸长，锚本身保持在把手的接收部内的位置。
图9C示出了在移出插入的器械时的阀100，此时阀材料150和160朝着把手30这边弹回。然而，因为阀材料150紧固在盖子40和把手30之间，当已经从把手30和盖子40之间的的初始位置朝着阀式导入器20的中心移动的伸长的阀材料150的返回至初始位置被阻止时群聚效应发生。这种现象通过图9C中的格子线得到显示，其显示了在阀材料150中的标志之间的距离大约等同于图9B中的距离，然而在阀材料160中的标志之间的距离稍微减小。该群聚效应导致阀100具有如图9D所示的鸭嘴状的构造，其显示了随着器械的移出阀的中心区域的下面的构造。这种构造提供了超越现有技术的优良密封。在一个实施例中，阀100设有润滑剂以减轻阀和插入的器械之间的表面摩擦，从而维持所希望的鸭嘴形状。
将护套导入器20从通过其插入的器械(例如，导管)的移出是这样完成的：抓住把手30的各个边并将各个边以相反的方向拉动，以便把手30沿着狭槽36裂开。在把手30裂开并分离时，完整的阀100沿着中心狭缝110和外围狭缝112、114形成的狭缝线分裂，如上所述，分裂过程通过维持阀100的各个边在对应的把手的边内的位置的锚102、104得以实现。当把手的两块相互被拉开时，护套在把手狭槽(其对应所对准的护套的预分离部)的圆周位置整个剥掉。由于制造PTFE的挤出过程形成分子的对准，护套的整个长度在圆周位置连续地剥离而无需刻线。把手在分离过程中或者之后并不与护套分离。在本发明的其它的实施例中，护套由PTFE或者另一类似聚合物材料制成带有一个或多个与把手中的狭槽一致的、沿着护套的长度纵向定位的刻线。
如图10至图13所示，在阀式护套导入器的另一个实施例中，阀结合有非常细的线。图10显示了组装前的把手230、盖子240和包括单个的锚202和细线204的阀200。细线204圈过阀200的中心狭缝且其两端延伸出阀200的边缘并连结在一起以定位在把手230中。阀200的中心狭缝垂直于把手230的狭槽定向，这与上述的阀100的轴向对准不同。应该注意，在此图中盖子240具有构造成可接收在把手230的类似形状的延长的图案中的延长的图案242以改进其间的连接。图11显示了放入把手30中的阀200。图12通过盖子240和把手230的半剖视图以及阀的顶部透视图显示了把手230、盖子240和阀200的相互作用，而图13显示了把手230和盖子240另一个半剖视图以及阀200的横截面图。
在图13中，可以看到把手230的接收细线204的侧边还具有空的接收部238，这是由于阀200没有用于定位在其中的锚。尽管在一些实施例中不存在该空的接收部，在本实施例中接收部存在于把手230的两边，通过允许锚202在把手任一边的定位以便阀式护套导入器的制造。当分开把手230以移出插入的器械(例如，导管)时，细线204保留在已经被设有细线的延伸部分的半个把手230上(图11)，而阀200保留在其内设有锚202的另一半上(图12、图13)。从而，当把手230的两半以相反的方向拉开时，细线204将阀200切成两个部分以便移出插入的器械。
此处说明的阀式护套导入器根据下面的一个实施例进行使用。在确定人体上的进入部位并对其切口后，阀式护套导入器部件插入人体且护套主体的远端延伸入待进入的人体血管。在可选择的准备步骤(例如，清洗)之后，从阀式护套导入器移开扩张器。当移开扩张器时，阀如以上结合图9A至图9C所述的关闭。然后可以通过阀式护套导入器将导管或者其它的医疗卫生器材插入人体血管。当完成定位所希望的更多的诸如导管的永久性医疗卫生器材之后，阀式护套导入器即可移开。在一个实施例中，通过以相反的方向(亦即，远离插入的医疗卫生器材)拉开把手的第一侧边和一个第二侧边将把手裂开。该裂开动作可以例如沿着定位在第一和第二侧边之间的把手的狭槽发生。通过拉开把手，阀被分开并使其一部分保留在把手的第一侧边上而其另一部分保留在把手的第二侧边上，这在此处的示范性的实施例中进行了说明。一旦把手裂开而第一和第二侧边持续以远离插入的医疗卫生器材的大致相反的方向拉开，护套主体在其上度上裂开以便将阀式护套导入器从插入的医疗卫生器材周围的完全移出成为可能，而无对在人体血管中的医疗卫生器材的定位的影响。
本发明及其具体的实施例已经进行了说明。尽管本发明已经采用详细的变化和图示进行了说明，本领域内的技术人员应明白本发明并不受限于该变化或者图示。另外，上述的方法和步骤指出了以某些顺序发生的某些事件，本领域内的技术人员应明白某些步骤的顺序可以改变而这种改变是与本发明的改变一致的。此外，在可能的情况下某些步骤可以同时执行，或者如上所述地顺序执行。因此，在本揭露书的精神范围内的或权利要求中的本发明的等同物的变更都覆盖在本专利范围内。最后，本说明书中所引用的所有专利和专利申请均通过引用全部结合于本文中，就如同各个专利或者专利申请已经在此处明确且个别地进行了描述。

Claims (20)

1.一种用于将医疗卫生器材插入人体的器械，包括：
包括护套主体和把手的护套，所述把手包括一个或多个接收部；
包括通过其中心部的狭缝和构造成用于插入对应把手接收部的一个或多个锚定元件的阀，所述锚定元件沿着阀的边缘进行定位；以及
连接于所述把手的盖子，所述阀的至少一部分压缩在其间。
2.根据权利要求1所述的器械，其特征在于，所述阀的中心部具有大于阀的周围部的厚度。
3.根据权利要求1所述的器械，其特征在于，所述中心部的一边上具有凹面。
4.根据权利要求3所述的器械，其特征在于，所述中心部具有相对的凹面。
5.根据权利要求1所述的器械，其特征在于，所述护套是具有在其内贯穿的内腔的管状构造，所述中心部是圆形的并且具有大约等于所述护套内腔的直径的直径。
6.根据权利要求1所述的器械，其特征在于，所述把手包括定位在所述护套主体的相对边的第一把手元件和第二把手元件，所述第一把手元件和第二把手元件均包括接收部。
7.根据权利要求6所述的器械，其特征在于，所述阀包括构造成用于插入所述第一把手元件的接收部的第一锚定元件，以及构造成用于插入所述第二把手元件的接收部的第二锚定元件，所述第一锚定元件和第二锚定元件沿着相对的阀边缘进行定位。
8.根据权利要求6所述的器械，其特征在于，所述把手包括定位在所述第一把手元件和第二把手元件之间的相对的狭槽区域。
9.根据权利要求1所述的器械，其特征在于，所述盖子以超声波焊接于所述把手。
10.根据权利要求1所述的器械，其特征在于，所述中心狭缝以关于所述阀的顶面约成45度的角度通过所述阀的中心部进行定位。
11.根据权利要求1所述的器械，其特征在于，所述阀进一步包括定位在所述阀的边缘的至少一个外围狭缝，所述外围狭缝与所述中心狭缝对准。
12.根据权利要求1所述的器械，其特征在于，所述阀进一步地包括定位在相对的阀的边缘的两个外围狭缝，所述外围狭缝与所述中心狭缝对准。
13.根据权利要求12所述的器械，其特征在于，所述把手进一步包括定位在第一把手元件和第二把手元件之间的相对的狭槽区域，所述第一把手元件和第二把手元件定位在所述护套主体的相对边上，所述外围狭缝和所述中心狭缝与所述相对狭槽区域对准。
14.根据权利要求1所述的器械，其特征在于，所述阀进一步地包括定位在相对的阀的边缘的两个外围凹槽，所述外围凹槽与所述中心狭缝对准。
15.根据权利要求1所述的器械，其特征在于，所述把手包括定位在所述护套主体的相对边的第一把手元件和第二把手元件以及定位在所述第一把手元件和第二把手元件之间的相对的狭槽区域，其中，所述第一把手元件包括所述接收部。
16.根据权利要求15所述的器械，其特征在于，所述中心狭缝与所述相对的狭槽区域垂直对准。
17.根据权利要求16所述的器械，其特征在于，进一步包括圈过所述中心狭缝的线，所述线具有定位在所述第二把手元件中的两个末端。
18.根据权利要求1所述的器械，其特征在于，在器材通过所述阀插入时，所述阀的材料向内伸长，而在所述器械从所述阀移出时，所述材料的一部分被阻止返回到其在所述盖子和所述把手之间的初始位置，并形成产生在围绕所述狭缝的所述中心部的鸭嘴构造的群聚效应。
19.一种用于将医疗卫生器材插入人体的器械，包括：
阀，其包括用于将所述阀锚定在把手中的锚定装置和用于允许器材通过所述阀进入并在所述器材从所述阀移出时用于密封的自动密封装置，所述自动密封装置包括一构造，所述构造在所述器材从其中移出后与所述器材通过其插入前的构造不同；以及
连接于所述把手的盖子，临近所述锚定装置的所述阀的至少一部分压缩在其间。
20.一种用于组装阀式护套导入器的方法，包括：
将阀插入把手中，所述阀包括定位在所述把手的接收部中的至少一个锚定元件和中心部，所述中心部具有约等于连接于所述把手的护套的直径的直径；以及
以压力将盖子连接到所述把手使所述阀的至少一部分定位在其间，所述阀的部分压缩到比将所述盖子连接到所述把手前的厚度更小的厚度。
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US20100101069A1 (en) 2010-04-29
US20190274722A1 (en) 2019-09-12
EP1740253A1 (en) 2007-01-10
WO2005107843A1 (en) 2005-11-17
DE602005008936D1 (de) 2008-09-25
US20150289903A1 (en) 2015-10-15
US7637893B2 (en) 2009-12-29
US8720065B2 (en) 2014-05-13
US10307182B2 (en) 2019-06-04
US9108033B2 (en) 2015-08-18
US20120184913A1 (en) 2012-07-19
US20050267487A1 (en) 2005-12-01

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