CN101242868B - 静脉导管插入装置及其使用方法 - Google Patents

静脉导管插入装置及其使用方法 Download PDF

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CN101242868B
CN101242868B CN200680030392XA CN200680030392A CN101242868B CN 101242868 B CN101242868 B CN 101242868B CN 200680030392X A CN200680030392X A CN 200680030392XA CN 200680030392 A CN200680030392 A CN 200680030392A CN 101242868 B CN101242868 B CN 101242868B
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catheter insertion
safety guidewire
pin
insertion apparatus
needle carrier
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CN101242868A (zh
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A·贝尔森
G·W·霍尔
S·A·丹尼尔
R·布罗梅尔
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Vascular Pathways Inc
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    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09041—Mechanisms for insertion of guide wires
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
    • A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
    • 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
    • A61M25/09—Guide wires
    • A61M2025/09133—Guide wires having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/065—Guide needles
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3232—Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234—Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3257—Semi-automatic sleeve extension, i.e. in which triggering of the sleeve extension requires a deliberate action by the user, e.g. manual release of spring-biased extension means

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Abstract

本发明公开了静脉导管插入装置及其使用方法。该插入装置协调进入针、共轴的静脉导管和挠性安全引导线的运动。进入针刺入静脉，然后使用插入装置上的致动构件将安全引导线推入静脉中。安全引导线允许进入针和静脉导管安全地推入静脉中。然后，致动该致动构件以便同时缩回进入针和安全引导线，仅留静脉导管在静脉中。随后，静脉导管与插入装置分离，并与静脉流体源、药物源等连接。

Description

静脉导管插入装置及其使用方法
本申请要求享有2005年7月6日提交的申请号为60/697,333的美国临时申请的优先权。该临时申请以及这里引用的所有专利和专利申请的内容通过引用并入本文。
技术领域
本发明涉及用于将静脉导管插入和布置到患者的静脉或动脉中的装置和方法。本发明的装置和方法便于安全地将导管布置在患者的静脉或动脉中，这在脉管较小、曲折、萎缩、脆弱和/或难于定位脉管的情况下特别重要。这些装置和方法也提供了对在布置静脉导管之后由针引起的意外刺扎和/或污染的保护。
背景技术
以下专利描述了已有的用于注射器和针的静脉导管插入装置和/或安全装置。
Haining的EP00515710A1，题为“Intravenous catheter andinsertion device”；
Haining的EP00515710B1，题为“Intravenous catheter andinsertion device”；
Haining的US05019049，题为“Intravenous catheter andinsertion device”；
Haining的US05176650，题为“Intravenous catheter andinsertion device”；
Chang的EP00567321A2，题为“Intravenous catheter withneedle guard”；
Mahurkar的EP00652020B1，题为“Retractable hypodermicneedle assembly”；
Mahurkar的EP00910988A1，题为“Blood sample collectionassembly”；
Mahurkar的US05891105，题为“Hypodermic needle assembly”；
DeWitt的US03572334，题为“Intravenous catheter placementunit”；
van Heugten的EP00750916A2，题为“Protective needle covercontainment”；
Botich的EP00942761B1，题为“Medical device withretractable needle”；
Botich的EP01075850B1，题为“Apparatus for intravenouscatheter insertion”；
Botich等人的US05800395，题为“Medical device withretractable needle”；
Botich等人的US06436070，题为“Catheter insertion devicewith retractable needle”；
Botich等人的US23060760A1，题为“Catheter insertion devicewith retractable needle”；
Botich等人的WO00012160A1，题为“Fluid infusion devicewith retractable needle”；
Botich的WO09632981A1，题为“Safety stylet for intravenouscatheter insertion”；
Botich的WO09824494A1，题为“Medical device withretractable needle”；
Shue的EP01457229A1，题为“Intravenous catheter insertingdevice”；
Shue的US24106903A1，题为“Intravenous catheter insertingdevice”；
Harautuneian的US03592192，题为“Intravenous catheterapparatus with catheter telescoped on outside of puncturingcannula”；
Harautuneian的US03610240，题为“Intravenous catheterapparatus with catheter telescoped inside puncturingcannula”；
Poncy等人的US04037600，题为“Catheter placement system”；
Hession的US04292970，题为“Apparatus for intravenouscatheter starter”；
McDonald的US04834718，题为“Safety needle apparatus”；
McDonald的US04944725，题为“Safety needle apparatus”；
Vining等人的US04909793，题为“Intravenous catheterapparatus with retractable stylet”；
Carrell等人的US04944728，题为“Intravenous catheterplacement device”；
Kaufman的US04966589，题为“Intravenous catheter placementdevice”；
Shields的US05007901，题为“Intravenous catheter insertiondevice”；
Haughton等人的US05562629，题为“Catheter placement systemutilizing a handle，a sharp，and a releasable retainermechanism providing retraction of the sharpupon disengagementof the catheter from the handle”；
Flumene等人的US05562634，题为“Intravenous catheter withautomatically retracting needle-guide”；
Isaacson的US05573510，题为“Safety intravenous catheterassembly with automatically retractable needle”；
Isaacson的US06056726，题为“Self-contained safetyintravenous catheter insertion device”；
Isaacson的WO09523003A1，题为“Self-contained safetyintravenous catheter insertion device”；
Huang的US05891098，题为“Safety intravenous catheter”；
Bhitiyakul的US05941854，题为“Intravenous catheter”；
Dysarz的US05997507，题为“Biased spring hard needleretractable IV catheter”；
Dysarz的US06193690，题为“Inclined plane latching devicefor an IV catheter”；
Greene等人的US06221047，题为“Safety intravenous catheterassembly and method for use with a needle”；
Greene等人的US06689102，题为“Safety intravenous catheterassembly”；
Greene等人的US06695814，题为“Safety intravenous catheterassembly and method for use with a needle”；
Greene等人的US21014786A1，题为“Safety intravenouscatheter assembly and method for use with a needle”；
Greene等人的US22165497A1，题为“Safety intravenouscatheter assembly”；
Greene等人的WO00006226A1，题为“Safety intravenouscatheter assembly and method for use with a needle”；
Chang的US06322537，题为“Safety intravenous catheter”；
Pressly，Sr.等人的US06620136，题为“Retractable I-Vcatheter placement device”；
Pressly，Sr.等人的WO00047256A1，题为“Retractable I-Vcatheter placement device”；
Hoffman等人的US06730062，题为“Safety catheter withnon-removable retractable needle”；
Hoffman等人的US23073956A1，题为“Safety catheter withnon-removable retractable needle”；
Brustowicz的US24267204A1，题为“On-demand needleretaining and locking mechanism for use in intravenouscatheter assemblies”；
Garcia Andreo的WO03043686A1，题为“Flowregulating/autovalve intravenous catheter”；
Sircom的WO09222344A1，题为“Needle guard for intravenouscatheter placement”；
Ogle的WO09519193A1，题为“Retractable venipuncturecatheter needle and receptacle”；
Rohrbough等人的WO09705912A2，题为“Retractablevenipuncture catheter needle and receptacle”；
Hwang的WO09721458A1，题为“Intravenous catheter withflexible extender and protector against needle tip”。
发明内容
在一方面，本发明提供了一种静脉导管插入装置，其协调进入针、静脉导管和安全引导线的运动。该装置保持进入针和静脉导管共轴布置，用于刺入静脉或其它目标脉管。血液回吸室提供可见指示，示意针的尖端位于静脉腔中。在进入针刺入静脉的基础上，使用定位在装置外部的致动构件推进挠性安全引导线穿过进入针进入静脉腔。由于挠性安全引导线配置在静脉腔内，进入针和静脉导管能够安全地推入静脉中，直到静脉导管的尖端也位于静脉腔内为止。替代地，在保持进入针静止时，可以单独地推进静脉导管。然后，致动该致动构件，以便同时缩回进入针和安全引导线。优选地，通过弹簧或其它偏压构件的作用自动缩回进入针和安全引导线，仅留静脉导管在静脉中。一旦缩回了进入针和安全引导线，静脉导管能够与插入装置分离，并与静脉流体源、药物源等连接。
在另一方面，本发明提供了改进的用于插入和布置静脉导管的方法。该方法包括以下步骤：利用与静脉导管同轴布置的进入针刺入静脉或其它目标脉管中；查证进入针的尖端定位在静脉腔中；推进安全引导线穿过进入针进入静脉腔，将静脉导管的尖端推入静脉中；以及同时从静脉导管和患者体内缩回进入针和安全引导线。
尽管本发明针对插入静脉导管进行描述，但这里描述的设备和方法可以容易地适于将任何导管或类似装置插入静脉、动脉或其它内部身体结构中。
附图说明
图1是根据本发明的静脉导管插入装置的分解图；
图2是处于未配置状态的静脉导管插入装置的装配图，该装置待使用；
图3是静脉导管插入装置的透视图，其中安全引导线被推进；
图4A和4B是用于静脉导管插入装置的安全引导线的细部图；
图5A、5B和5C是用于静脉导管插入装置的另一种安全引导线的细部图；
图6示出了根据本发明的静脉导管插入装置的另一种实施方式；
图7-9示出了根据本发明的静脉导管插入方法。
具体实施方式
图1是根据本发明的静脉导管插入装置20的一种实施方式的分解图。图2是处于未配置状态的静脉导管插入装置20的装配图，该装置20待使用。图3是静脉导管插入装置的透视图，其中安全引导线已推进。
静脉导管插入装置20包括外壳1。在所示例子中，外壳1为细长的空心圆筒。外壳1也可以是其它形状的，包括适于人机工程学的握把形等。外壳1可以由任何适用于医疗应用的材料制成。在一种实施方式中，优选地，外壳1由刚性的透明医用塑料模制而成。替代地，外壳1可以由挤压的塑料管机加工而成。
在外壳1中有细长槽14，该细长槽14与外壳1的轴线基本上平行。该槽14的大小适于容纳定位销10，或为滑块4提供连接点以使该滑块沿着外壳1的内部运动。槽14的远端加宽成三角形切口15，如图2和3所示。切口15可以是其它形状的。
前插头2的大小适于配合在外壳1的远端上。优选地，前插头2由刚性的透明医用塑料模制而成或以替代的方法机加工而成。前插头2被胶合到、销接到、焊接到或以其它方式固定到外壳1的远端上。前插头2的远端包括鲁尔滑动接头(luer slip fitting)16或类似物。肩部或凸缘17与外壳1的远端配合。前插头2的近端具有联锁构件18，该联锁构件18与针托架6上的配对联锁构件19联锁。在所示例子中，联锁构件18是凸片，该凸片与位于针托架6上的相应螺旋棘爪或直角回转螺纹联锁构件19联锁。联锁构件18、19可以具有其它几何结构。
在图1-3的示例性实施方式中，所选择的槽14和三角形切口15的几何结构适于与旋转式联锁构件18、19进行协作。槽14允许致动器手柄9相对于外壳1沿纵向运动以便向远侧推进安全引导线11，同时限制横向运动，以避免进入针8和安全引导线11过早缩回。在槽14的远端处将其加宽成三角形切口15允许致动器手柄9可选择地横向旋转，以分离旋转式联锁机构18、19并释放偏压构件12以便在安全引导线11被完全推进之后缩回进入针8和安全引导线11。如果代替旋转式联锁构件18、19而使用不同的几何结构或不同的释放机构，那么需要对槽14和三角形切口15的几何结构进行变型，以适应释放机构。
针托架6的形状和尺寸适于配合在外壳1内。在图1-3所示实施方式中，针托架6为圆柱形，其尺寸适于使其在圆柱形外壳1的内部滑动配合。针托架6可以是其它形状，通常，该针托架6的形状与外壳1的内部几何形状相适应。优选地，针托架6由适用于医用环境中的任何材料模制或以替代的方法机加工而成。在一种实施方式中，针托架6由刚性的透明医用塑料形成。具有锋利倾斜远端的管状进入针8连接到针托架前缘5上，该针托架前缘5又连接到针托架6上。优选地，进入针8由不锈钢皮下注射管制成。在针托架6中针托架前缘5和针托架6之间设置与进入针8的管腔连通的小腔或血液回吸室。如上所述，针托架6的远端具有联锁构件19，该联锁构件19能够与前插头2的近端上的配对联锁构件18联锁。在一种示例性实施方式中，联锁构件18、19适于通过相对于前插头2旋转针托架6来锁定和解锁。联锁构件18、19也可以使用卡口接头来锁定和解锁。在所示的例子中，联锁构件是螺旋棘爪联锁构件19，其与位于前插头2上的相应凸片联锁构件18联锁。在一种实施方式中，联锁构件利用针托架6的少于一整转来锁定和/或解锁。在另一种实施方式中，联锁构件利用针托架6的少于二分之一转来锁定和/或解锁。在又一种替代的实施方式中，联锁构件利用针托架6的少于四分之一转来锁定和/或解锁。联锁构件可以是其它几何结构。
偏压构件12能够配合在针托架6和前插头2之间，以促使针托架6和前插头分离。当针托架6和前插头2锁定在一起时，通过联锁构件18、19来抵抗偏压构件12的力。在一种实施方式中，偏压构件12是弹簧。需要注意的是，图1中示出了处于压缩状态的偏压构件或压缩弹簧12，所述偏压构件或压缩弹簧12在已装配的处于未配置状态的静脉导管插入装置20中即处于上述压缩状态。
在一种替代的实施方式中，联锁构件18、19可以由利用脆性接头结合在一起的两个构件或具有脆性部分的单个构件来替代。该单个构件或两个构件能够限制偏压构件12，直到需要该偏压构件12缩回进入针8和安全引导线11为止，此时，致动器将断开脆性接头或脆性部分，以释放偏压构件12。这种构造将使装置20更能抵抗重复制造或重复使用。
诸如ANGIOCATH的管状静脉导管13围绕进入针8共轴配合。优选地，该静脉导管13与进入针8和锥形远端紧密配合，以便当进入针8和静脉导管13穿过脉壁插入时使得进入针8和静脉导管13之间的台阶最小化。在静脉导管13的近端上有鲁尔接头27或类似物，该鲁尔接头27配合到前插头2的远端处的鲁尔滑动接头16上，其间具有轻微干涉配合以便将静脉导管13保持在适当的位置。该装置的替代结构可以使用鲁尔锁或其它锁定机构，以将静脉导管13连接到前插头2上。
滑块4是大致圆柱形的，且其尺寸适于使其在圆柱形外壳1的内部滑动配合。依据外壳1内部的几何形状，滑块4可以具有其它形状。优选地，滑块4由任何合适的医用材料模制而成或以替代的方法机加工而成。例如，滑块可由刚性医用塑料形成。手柄9或致动构件利用定位销10或其它穿过外壳1中的槽14延伸的连接构件连接到滑块4上。滑块4配合在外壳1中位于针托架6近侧。销25从滑块4的远侧表面处延伸，并且能够可逆地与位于针托架6的近端上的孔、阶梯、凸起部或类似的配对部件26接合。当销25在静脉导管适当插入和布置操作的步骤中连接到配对部件26上时，滑块4的旋转传递给针托架6，以便于联锁构件18、19的接合和/或分离。销25和部件26仅为示例性的。销25可以由凹形部件替代，而配对凸形部件可以布置在针托架6的近侧面上。此外，配对部件25、26相对于细长槽和滑块4的滑动对准，从而滑块4向远侧的运动将使配对部件25、26接合。可选择地，当装置20被致动时，该装置20可以被构造成使得滑块4和针托架6之间形成不可逆连接。
如图3所示，安全引导线11直接或间接地连接到滑块4上，从而利用连接在滑块4上的手柄9推进和缩回安全引导线11。在一种优选实施方式中，安全引导线11是超弹性镍-钛合金(镍钛诺)线。由于这种类型的线具有极好的柔性，因此有利地，沿安全引导线11长的大部分包封该安全引导线11，以避免在安全引导线11被推进时其发生弧状弯曲或扣住。基于这个原因，示出的例子包括与针托架6的近端连接的支撑管道7。安全引导线11穿过护套管道3的内腔延伸，并且安全引导线11的近端与护套管道3的近端连接。护套管道3的远端又连接到滑块4上，间接地将安全引导线11连接到滑块4上。支撑管道7在护套管道3的内部滑动配合，使得这两个部分在滑块4被向远侧推进时套在一起。支撑管道7和护套管道3的套入动作给安全引导线11的近侧部提供了可变长度的支撑，以防止安全引导线11在被推进时发生弧状弯曲或扣住。优选地，支撑管道7和护套管道3由不锈钢皮下注射管制成，然而，也可以使用任何适当的医用塑性材料。在其它实施方式中，对于那些具有较大直径或较大硬度的引导线，可以不必使用伸缩式支撑管道，并且安全引导线11的近端可以直接连接到滑块4上。
图4A和4B是用于静脉导管插入装置20的安全引导线11的详细示图。优选地，安全引导线11是超弹性镍-钛合金线，直径大约为0.004-0.012英寸，最优选地，直径大约为0.008英寸。如图4B所示，对安全引导线11的远端进行紧密地螺旋卷绕，使其外径小于目标脉管的内径，其中，安全引导线11将插入到该目标脉管中。螺旋尖端用作引导线上的安全缓冲部，以避免目标脉管内侧被刺伤或损伤。卷成螺旋的引导线尖端对保护脆性或柔嫩的静脉尤其有利。由于镍-钛合金线具有极好的柔性，因此当安全引导线11被缩回到进入针8中时远侧的螺旋曲线能够伸直，而当安全引导线11被推出进入针8时远侧的螺旋曲线能够完全恢复到螺旋结构且不发生塑性变形。在示出的例子中，安全引导线11的远端具有大约0.75转的直径大约为0.167英寸的第一圈，和大约1整转的直径大约为较大的0.175英寸的第二圈。第一和第二圈优选彼此大致共面，且优选与引导线11的直的近侧部大致共面。安全引导线11的其它结构可以包括：多平面、单圈、在端部处具有全半径和/或球形端部，该球形端部的直径小于针的直径。
图5A、5B和5C是用于静脉导管插入装置20的另一种安全引导线11的详细示图。在该实施方式中，通过磨削、拉伸等将直径大约为0.008英寸的镍-钛合金线的远侧部渐缩成大约为0.004英寸的直径，以使该合金线更具柔性并允许将其形成直径较小的螺旋以便用于直径较小的静脉中。优选地，引导线尖端的螺旋曲线的外径比目标脉管的内径小。在示出的例子中，螺旋曲线具有大约0.75转的直径大约为0.034英寸的第一圈，和大约1整转的直径大约为0.059英寸的第二圈。第一和第二圈优选彼此大致共面，且优选与引导线11的直的近侧部大致共面。
安全引导线11也可以具有其它尺寸和几何结构。
为了装配图1-3所示的静脉导管插入装置20，将进入针8与针托架前缘5的近侧面齐平连接，该针托架前缘5又连接到针托架6中。支撑管道3布置在针托架6中的远侧孔内，并且与血液回吸室的近侧面齐平连接。形成的安全引导线11被推进穿过进入针8和支撑管道7的腔，直到安全引导线11的螺旋部分接触到进入针8的斜面为止。护套管道3穿过滑块4滑动，并且在与滑块4的远侧面齐平时连接。护套管道3和滑块4的装配结构在安全引导线11上推进。当安全引导线11与护套管道3的近端齐平时，两者相连接。弹簧12被压缩在针托架前缘5上，推进前插头2，前插头2的联锁构件18、19和针托架6接合。上述各部件装配完成后布置在外壳1中并且被推进直到前插头2与外壳1齐平为止，随后旋转前插头2以适当地对准。然后将前插头2连接到外壳1上。定位销10和手柄9与滑块4按压在一起。手柄9向近侧滑动以将安全引导线11缩回到进入针8中，由此将远侧的螺旋曲线拉直。接着，将静脉导管13围绕进入针8共轴地安装。可选择地，静脉导管13插入装置可以具有针罩或其它保护性包装材料。最后，对已装配的包括静脉导管13的静脉导管插入装置20进行封装、贴标签和消毒。
前面对装配的描述用于示出一种实施方式的静脉导管插入装置20的制造过程的一个例子，并且也有利于理解各部件之间的关系。依据具体选择的装配或制造技术对前述作出变型和改变。例如，可以对连接在一起的部件进行重新设计成一体地的单个部件等。可以对制造过程进行变型，适于装配其它实施方式的静脉导管插入装置20。
图6示出了根据本发明的静脉导管插入装置20的另一种实施方式的内部视图。该实施方式在很多方面与图1-3的静脉导管插入装置20类似。静脉导管插入装置20包括：外壳1；前插头2，其可选择地与外壳1一体地模制而成；针8，其与针托架6连接；安全引导线11；弹簧12和静脉导管13。但是，手柄9和滑块4的功能由与一对摩擦轮22、23接合的指轮21替代，该对摩擦轮22、23与安全引导线11接触。同样，护套管道3和支撑管道7的功能由引导线卷轴24替代。这些特征允许静脉导管插入装置20具有更加紧凑的结构。在使用中，通过转动指轮21来推进安全引导线11。指轮21的横向运动使得针托架6与前插头2分离，允许偏压构件12伸张，由此将针8和安全引导线11缩回到外壳1中。替代地，分离按钮、杆或其它致动构件能够用于致动缩回针8和安全引导线11。引导线卷轴24可选择地包括旋转弹簧或类似的机构(未示出)，以辅助将安全引导线11缩回到外壳1中。
图7-9示出了使用例如图1-3或图6中描述的静脉导管插入装置20插入静脉导管的方法。静脉导管插入装置20是一次性、不能重复使用的装置，以如图2所示处于待使用的未配置状态提供给医生或医师消毒。在使用中，医生将外壳1用作手柄，以操作静脉导管插入装置20。当装置处于未配置状态时，进入针8刺入静脉，如图7所述。当观察到血液回吸室中出现静脉血时，则进入针8的远侧尖端处是静脉腔。然后，医生可以向远侧推进手柄9，以使安全引导线11伸出静脉腔中的进入针8。安全引导线11的远侧部采用螺旋结构，该螺旋结构用作安全缓冲部，以防止意外刺伤静脉远壁或对静脉造成其它损伤。安全引导线11按上述配置，医生能够安全地继续推进静脉导管插入装置20，直到静脉导管13的远侧尖端在静脉腔中为止。一旦静脉导管13插入到静脉中足够远处，医生转动手柄9，从而转动滑块4，该滑块4又转动针托架6并使针托架6的联锁构件18与前插头2上的配对联锁构件19分离。(在上述示例性实施方式中，外壳1中槽14的远端处的三角形切口15允许手柄沿逆时针方向运动。图1-3中更加详细地示出了致动器机构的其它结构特征。)当释放手柄9时，偏压元件(这里是指压缩弹簧12)使针托架6和滑块4向近侧运动，由此同时将进入针8和安全引导线11缩回到外壳1中，仅使静脉导管13留在静脉腔中。图8示出了将进入针8和安全引导线11缩回到外壳1中。三角形切口15的形状允许手柄9在受偏压元件12作用向近侧运动时平稳地过渡到细长槽14中。最后，静脉导管13与前插头2的远端上的鲁尔滑动接头16分离，如图9所示，并且静脉流体源、注射器或其它装置与静脉导管13的鲁尔接头27连接。
尽管需要静脉导管插入装置20同时缩回进入针8和安全引导线11，但可以对致动器机构进行变型以便顺序地缩回进入针8和安全引导线11。例如，致动器机构可以先缩回进入针8，稍后再缩回安全引导线11。
替代地，可以对致动器机构进行变型，从而需要一个致动器构件作两种独立的运动或两个独立的致动器构件作可选择的运动以便选择性地缩回进入针8和安全引导线11。
在静脉导管插入装置20的一种替代实施方式中，可以从致动器机构中省去压缩弹簧12，由此允许使用手柄9来手动地缩回进入针8和安全引导线11。一旦静脉导管13被插入到患者的静脉中，横向旋转手柄9以使针托架6和前插头2分离，然后使手柄9沿着槽14向近侧运动，以便将进入针8和安全引导线11缩回到外壳1中。
尽管这里通过示例性实施方式和实施本发明的优选方式对本发明进行了描述，但本领域普通技术人员可以理解，在不背离本发明精神和范围的情况下可以对本发明的各种实施方式、适应和改变作出多种变型、改进和组合。例如，说明书或附图中包括的所有尺寸和材料仅作为优选实施方式的例子，并不用来限定本发明的范围。

Claims (15)

1.一种导管插入装置，包括：
外壳；
管状进入针，其与针托架连接，所述针托架能够相对于所述外壳滑动；
管状导管，其可释放地连接在所述外壳的远端，并且围绕所述管状进入针共轴地定位；
安全引导线，其尺寸和结构适于被穿过所述管状进入针推进；
以及致动器机构，其能够选择性地向远侧推进所述安全引导线穿过所述管状进入针，并随后相对于所述管状导管向近侧缩回所述安全引导线和所述管状进入针。
2.根据权利要求1所述的导管插入装置，还包括：
偏压构件，其能够通过所述致动器机构的致动自动地相对于所述管状导管向近侧缩回所述安全引导线和所述管状进入针。
3.根据权利要求2所述的导管插入装置，所述致动器机构还包括：
致动器手柄，其能够相对于所述外壳向远侧运动，以选择性地向远侧推进所述安全引导线穿过所述管状进入针；
所述致动器手柄能够横向旋转，以致动所述安全引导线和管状进入针相对于所述管状导管向近侧的缩回。
4.根据权利要求3所述的导管插入装置，还包括：
位于所述外壳中的细长槽，所述细长槽具有窄的近侧部和加宽的远侧部；
其中，所述致动器手柄能够相对于所述细长槽运动，使得所述细长槽的窄的近侧部限制所述致动器手柄在纵向上运动，以选择性地向远侧推进所述安全引导线穿过所述管状进入针，所述加宽的远侧部允许所述致动器手柄横向运动，以致动所述安全引导线和管状进入针相对于所述管状导管向近侧的缩回。
5.根据权利要求4所述的导管插入装置，还包括：
前插头，其固定在所述外壳的所述远端上，所述前插头具有近端，所述近端上具有凸片，所述凸片与位于所述针托架的远端上的螺旋棘爪可转动地联锁；
所述偏压构件具有压缩状态，其中所述偏压构件被压缩在所述前插头和所述针托架之间；
其中，所述致动器手柄的横向运动使所述针托架旋转，由此使所述针托架与前插头分离，并允许所述偏压构件相对于所述外壳向近侧推动针托架。
6.根据权利要求5所述的导管插入装置，其中，所述前插头具有远端，所述前插头的所述远端具有鲁尔滑动接头，所述鲁尔滑动接头用于将所述管状导管可释放地连接到所述前插头上。
7.根据权利要求5所述的导管插入装置，还包括：
定位在所述外壳中的滑块，所述滑块与所述致动器手柄连接，所述滑块具有远端，在所述滑块的所述远端上具有凸出部，所述凸出部能够与所述针托架接合，并将所述滑块的旋转传递给所述针托架以使所述针托架与所述前插头分离。
8.根据权利要求7所述的导管插入装置，其中，所述安全引导线连接到所述滑块上。
9.根据权利要求1所述的导管插入装置，所述致动器机构还包括：
指轮，其能够相对于所述外壳旋转，以选择性地向远侧推进所述安全引导线穿过所述管状进入针。
10.根据前述权利要求中任一项所述的导管插入装置，其中，所述安全引导线具有形成为螺旋曲线的远侧部。
11.根据权利要求10所述的导管插入装置，其中，所述安全引导线的螺旋曲线包括第一螺旋圈和第二螺旋圈，所述第一螺旋圈的直径小于所述第二螺旋圈的直径。
12.根据权利要求11所述的导管插入装置，其中，所述安全引导线的螺旋曲线的所述第一螺旋圈与所述第二螺旋圈大致共面。
13.根据权利要求1所述的导管插入装置，其中，所述安全引导线包括近侧部和远侧部，所述安全引导线的所述近侧部的直径大于其所述远侧部的直径。
14.根据权利要求13所述的导管插入装置，其中，所述安全引导线的所述远侧部形成为螺旋曲线。
15.根据权利要求1所述的导管插入装置，其中，所述安全引导线由超弹性镍-钛合金形成。
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