CN108525102B - 导管插入装置 - Google Patents

导管插入装置 Download PDF

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CN108525102B
CN108525102B CN201710288072.4A CN201710288072A CN108525102B CN 108525102 B CN108525102 B CN 108525102B CN 201710288072 A CN201710288072 A CN 201710288072A CN 108525102 B CN108525102 B CN 108525102B
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safety cap
needle
housing
catheter
insertion tool
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CN108525102A (zh
CN108525102A8 (zh
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陈永权
黄河清
陈建疆
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CR Bard Inc
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CR Bard Inc
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    • 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
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0113—Mechanical advancing means, e.g. catheter dispensers
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0136—Handles therefor
    • 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
    • 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
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • 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
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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
    • A61M25/0693—Flashback chambers
    • 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
    • A61M25/09—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
    • A61M2025/0177—Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
    • 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
    • A61M2025/09116—Design of handles or shafts or gripping surfaces thereof for manipulating guide wires
    • A—HUMAN NECESSITIES
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/0618—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard
    • A61M25/0625—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for protecting only the distal tip of the needle, e.g. a needle guard with a permanent connection to the needle hub, e.g. a guiding rail, a locking mechanism or a guard advancement mechanism

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Abstract

提供了一种用于将导管插入患者体内的工具。该工具包括：壳体，导管的至少一部分初始设置在该壳体中；从壳体向远侧延伸的针，导管的至少一部分设置在针上；初始部分地设置在针内的导丝；以及用于向远侧推进导管的推进组件。该壳体包括：第一部，其包括远侧部分和近侧部分；以及与第一部接合的第二部；其中第一部的远侧部分构造成能够相对于第二部向远侧滑动以释放第一部和第二部之间的接合。该推进组件包括安全帽，其初始设置在针上并且构造成当向远侧滑动到将针的尖端隔离在安全帽内的位置时锁定到壳体。

Description

导管插入装置
技术领域
本发明涉及医疗装置，更具体地，涉及一种用于将导管插入患者体内的导管插入装置。
发明内容
本发明的实施例涉及一种用于将导管或其它管状医疗装置插入患者体内的插入工具。在一个实施例中，插入工具将针插入件、导丝推进器、从壳体向远侧延伸的针以及导管插入件集成在单个装置中以提供导管放置过程。
在一个实施例中，本发明的导管插入工具包括壳体、沿着针可滑动的安全帽，其中安全帽构造成当向远侧滑动到将针的尖端隔离在安全帽内的位置时被锁定到壳体。
在一个实施例中，安全帽包括包裹针的第一部和可滑动地附接到导轨的第二部，导轨是壳体的一体部分或固定至壳体。在可选实施例中，导管插入工具还包括导管套，其与安全帽连接，直到当安全帽向远侧滑动到隔离针的尖端的位置时被锁定到壳体上。
在一个实施例中，本发明的导管插入工具的壳体包括具有远侧部分和近侧部分的第一部和与第一部接合的第二部，其中第一部的远侧部分构造为能够相对于第二部向远侧滑动以释放第一部和第二部之间的接合。
在可选实施例中，壳体的第一部的近侧部分固定到第二部。在可选实施例中，钩设置在第一部的远侧部分的内表面上，钩具有朝向壳体的近端延伸的尖端，并且槽设置在壳体的第二部上，其中当第一部和第二部接合时槽接收钩，并且当第一部的远侧部分向远侧滑动时钩从槽中释放，使得第一部从第二部释放。
在可选实施例中，其中壳体的第一部的远侧部分的近端构造成轴向地锁定到壳体的第二部，并且第一部的远侧部分构造成当第一部的远侧部分的近端和第二部之间的锁定被释放时能够相对于第二部向远侧滑动，以便释放第一部和第二部之间的接合。在可选实施例中，第一部的远侧部分的近端是柔性的，并且当第一部的远侧部分的近端轴向地锁定到第二部时，被朝向第二部偏置。在可选实施例中，第一部的远侧部分的近端通过滑块朝向第二部偏置，并且其中当滑块向远侧移动到特定位置时，第一部的远侧部分的近端是不偏置的，并且第一部的远侧部分的近端和第二部之间的锁定被释放。
在可选实施例中，第一突起从远侧部分的近端向壳体的第二部延伸，并且第二突起从第二部向壳体的第一部的远侧部分的近端延伸，并且当第一部的远侧部分的近端朝向第二部偏置并且第一突起相对于第二突起处于近侧时，第一部的远侧部分的近端轴向锁定到第二部。
在一个实施例中，本发明的导管插入工具的隔挡件包括圆柱形主体和从主体的顶面的中心部延伸的第一突起。
在可选实施例中，本发明的隔挡件还包括沿着隔挡件的纵向轴线形成在隔挡件内的狭缝。可选地，狭缝形成在第一突起内。可选地，狭缝延伸穿过隔挡件。可选地，当针延伸穿过狭缝时狭缝被扩大，并且当针从隔挡件上抽出时狭缝被关闭。可选地，隔挡件的主体的外径大于在隔挡件安装在管腔中之前导管插入工具的管腔的内径。在可选实施例中，本发明的隔挡件还包括从主体的与顶面相对的底面的中心部延伸出的第二突起。
在一个实施例中，本发明的用于导管插入工具的隔挡件，包括：圆形端部和从圆形端部的外围延伸的管状部。在可选实施例中，本发明的隔挡件还包括从圆形端部的与管状部相对的表面的中心部延伸的突起。可选地，在端部内形成有狭缝。可选地，狭缝形成在突起内。可选地，狭缝延伸穿过端部。可选地，当针延伸穿过狭缝时，狭缝被扩大；并且当针被抽出时狭缝被关闭。
在一个实施例中，本发明的用于导管插入工具的导丝推进装置包括：推动块，包括从推动块的顶面到底面延伸穿过推动块的孔，其中孔的第一侧壁呈平坦曲线的形式；以及导轨，其包括在导管插入工具的纵向方向上与所述孔对准的凹槽。在可选实施例中，孔具有与第一侧壁相对的第二侧壁，第二侧壁是直的，第一侧壁和第二侧壁之间的最小距离足够宽以允许导丝的自由纵向移动并且足够窄以限制导丝的摆动。
在可选实施例中，导丝推进装置还包括锚定点，导丝的一端被固定到锚定点，且导丝从锚定点向近侧延伸，经由导轨的第一部进入孔，延伸离开孔并向远侧延伸进入所述导轨的第二部中。
在一个实施例中，本发明的用于导管插入工具的导丝推进装置包括：轮和齿条，齿条构造成使轮旋转，以使得导丝绕轮被驱动。可选地，导丝推进装置还包括齿轮，其同轴地固定至所述轮，其中所述齿条包括与所述齿轮接合的齿。可选地，导丝推进装置还包括用于将导丝限制在轮的外围表面的至少一个惰轮。可选地，导丝推进装置还包括用于引导所述导丝的运动的管状导轨。
在一个实施例中，本发明的插入工具包括：壳体，所述导管的至少一部分初始设置在所述壳体中；从所述壳体向远侧延伸的针，所述导管的至少一部分设置在所述针上；以及用于向远侧推进导管的推进组件。其中所述壳体包括：第一部，其包括远侧部分和近侧部分；和与所述第一部接合的第二部，其中所述第一部的远侧部分构造成能够相对于所述第二部向远侧滑动以释放所述第一部和所述第二部之间的接合；并且其中所述推进组件包括安全帽，所述安全帽初始设置在所述针上并且构造成当向远侧滑动到将所述针的尖端隔离在所述安全帽内的位置时被锁定到所述壳体。在可选实施例中，所述壳体的第一部和第二部的接合被释放，以准备使安全帽滑动到将针的尖端隔离在安全帽内的位置。
本发明的实施例的这些以及其他特征通过下面的说明书和所附权利要求将更加明显，或者可以通过此处所示的本发明的实施例的实践而习得。
附图说明
将通过参考在附图中示出的具体实施例来呈现本公开的更详细的描述。应当理解，这些附图仅描绘了本发明的典型实施例，因此不被认为是限制其范围。将通过使用附图以额外的特征和细节来描述和解释本发明的示例性实施例，其中：
图1是根据本发明的一个实施例的插入工具的立体图；
图2是图1的插入工具的横截面的俯视图；
图3A和3B是图1和图2的插入工具的各种分解图；
图4A-4C是根据本发明的一个实施例的导管插入工具的壳体的侧视图；
图4D示出了图4A-4C的壳体的内表面；
图5A-5C是根据本发明的一个实施例的导管插入工具的壳体的侧视图；
图5D-5F示出了图5A-5C的壳体的各种视图；
图6A和6B示出了根据本发明的一个实施例的插入工具的内部结构的各种视图；
图6C示出了根据本发明的一个实施例的插入工具的安全帽的结构；
图7A和7B示出了根据本发明的一个实施例的插入工具的导管套和安全帽之间的接合；
图8A是根据本发明的一个实施例的插入工具的安全帽和导轨的横截面的俯视图；
图8B是图8A的局部放大图；
图8C是图8A和8B的安全帽的横截面视图；
图9示出了根据本发明的一个实施例的设置在插入工具中的隔挡件；
图10A-10D示出了根据本发明一个实施例的隔挡件的各种视图；
图11A和11B示出了根据本发明的一个实施例的隔挡件的各种视图；
图12A和12B示出了根据本发明的一个实施例的导丝推进组件的各种视图；
图13A-13C示出了根据本发明的一个实施例的导丝推动器的各种视图；
图14A和14B示出了根据本发明的一个实施例的导丝推进组件的各种视图。
具体实施方式
现在将参考附图，其中相似的结构将被提供相似的附图标记。应当理解，附图是本发明的示例性实施例的图解和示意表现，并且既不是限制性的也不一定按比例绘制。
为了清楚起见，应当理解，词语“近”是指使用本文将要描述的装置相对更靠近临床医生的方向，而词语“远”是指距临床医生相对更远的方向。例如，放置在患者体内的导管的末端被认为是导管的远端，而导管的保留在身体外部的末端是导管的近端。此外，包括权利要求书在内，本文使用的词语“包含”、“具有”和“有”应具有与“包括”相同的含义。除非另有明确说明，否则“初始”一词是指当本发明的插入工具仍处于组装状态时被递送至诸如医院或诊所的医疗机构(或递送给患者由患者自己或患者的个人护理助理使用)，并且未被操作或使用的状态。除非另有说明，否则“轴向”或“轴向地”是指插入工具的纵向方向，也是针的定向。
本发明的实施例总体涉及一种用于辅助将导管或其它管状医疗装置放置在患者体内的工具。例如，各种长度的导管通常放置在患者的身体中，以便建立进入患者脉管系统的通路，并能够输注药物或吸入体液。这里要描述的导管插入工具便于这种导管放置。需要注意的是，虽然下文的讨论集中在特定类型且长度相对较短的导管的放置上，但是可以通过本装置插入各种类型、尺寸和长度的导管，包括外周IV中间或扩展性置留导管、PICC导管、中心静脉导管等。在一个实施例中，具有任何长度的导管是可能的。
首先参考图1和图2，图1和图2描绘了根据一个实施例的通常在10处描绘的导管插入工具(以下也称为“插入工具”)的各种细节。如图1所示，其是插入工具的立体图，插入工具10包括壳体12，壳体12又包括第一部12A和第二部12B。
在一个实施例中，壳体12的第一部12A与壳体12的第二部12B可分离地接合。在一个实施例中，第一部12A能够相对于第二部12B向远侧滑动以释放该接合。有关接合和释放的细节将在稍后提供。
图2是插入工具的横截面的俯视图。在一个实施例中，如图2所示，插入工具10包括导轨14，导轨14是壳体12的整体部分，或者是独立的元件，但固定到壳体12。例如，导轨14可以是壳体12的第一部12A(如图1所示)或壳体12的第二部12B的整体部分，或者通过模制或组装而固定到壳体12。
插入工具10还包括手柄16，用于临床医生在操作工具的同时稳定地保持工具10。在一个实施例中，手柄16从导轨14延伸。在其他实施例中，手柄16从壳体12延伸，其中手柄设置在壳体12的第一部12A或第二部12B上。在一个实施例中，手柄16的一个表面包括小突起以增加摩擦。在另一个实施例中，手柄16的表面包括可以增加摩擦的其它结构，例如凹槽、条痕、磨砂表面等。当诸如临床医师的使用者操作插入工具时，手柄16的表面上的这种突起或类似的结构改善了操作稳定性。
图3A和图3B是图1和图2的插入工具10的各种分解图。现在参考图3A，其中支撑中空针18的针座18A被放置在壳体部分12A和12B之间。针18从针座18A向远侧延伸，穿过插入工具10的主体并从壳体12的远端出来。在其它实施例中，针18至少部分是中空的，同时仍能实现本文所描述的功能。在一个实施例中，靠近针18的远端穿过针18的壁限定了凹口18B。一旦在导管插入过程期间进入患者的脉管系统，凹口18B即能够使得回流的血液(flashback of blood)离开由中空针18限定的管腔。因此，离开凹口18B的血液可以被临床医生观察到，以确认针被适当地插入脉管系统中。
如图2和3B所示，插入工具10还包括用于将导管22向远端推进到患者的脉管系统中的导管推进组件20。导管22的近端连接到导管套24。导管22和导管套24两者初始设置在针18上。导管22和导管套24的至少一部分预先设置在壳体12内。在一个实施例中，导管22的远侧部分延伸出壳体12的远端。在一个实施例中，导管套24包括从壳体上的槽12C延伸出壳体12的手柄，并且导管套24的手柄可用于实现导管22和导管套24的推进。槽12C存在于壳体12的第一部12A和第二部12B之间，允许导管套24的手柄的移动。在另一个实施例中，导管套24的手柄是从导管套24延伸的分支管24A。在另一个实施例中，向该分支管提供无菌保护。
继续参考图2和图3B，其中插入工具10包括安全帽26。安全帽26初始附接到导管套24，并且当其向远端滑到某一位置时可与导管套24分离。在一个实施例中，当滑动到该位置时，安全帽26被锁定到壳体12。下面将描述该锁定机构的细节。
在一个实施例中，安全帽26包括包裹针的第一部26A和可滑动地附接到导轨14的第二部26B。在一个实施例中，导管套24和安全帽26可分离的位置是针18的尖端隔离在安全帽26的第一部26A内的位置。在一个实施例中，当安全帽26滑动到将针18的尖端隔离在安全帽26的第一部26A内的位置时，安全帽26的第二部26B被锁定到导轨14。安全帽26(更具体地为第二部26B)与导轨14之间的锁定防止了安全帽26和针18之间的相对运动，避免了针的尖端的再次暴露，从而消除了针刺到临床医生或患者的可能性。
参考图3B，在一个实施例中，插入工具10还包括至少一个隔挡件28，以在针和导管插入患者体内或从患者体内取出时防止血液暴露。可以在插入工具10内放置一个或多个隔挡件。在一个实施例中，隔挡件28设置在导管套24的管腔内。在一个实施例中，隔挡件28设置在安全帽26的第一部26A上。在一个实施例中，隔挡件28设置在安全帽26的第一部26A的管腔内。要注意的是，隔挡件也可以设置在插入工具的其它元件内，例如，导管套24的分支管。隔挡件的尺寸和形状被构造为匹配对应的元件或该元件的管腔，并且当使用多个隔挡件时，每个隔挡件的尺寸和形状可以相同或不同。
返回参考图3A，在一个实施例中，插入工具10包括导丝推进组件30，用于将导丝32向远端推进进入患者的脉管系统或将其从其中抽出。在一个实施例中，导丝推进组件30还包括推动器34，用于操作导丝32的移动以准备导管22的推进。
在一个实施例中，导丝32的至少一部分设置在针18的管腔内。在可选实施例中，导丝32的远端初始设置在针18的尖端内，而导丝32的另一端固定在壳体12或导轨14上的锚定点。导丝32从锚定点向近侧延伸，进入设置在推动器34上的孔36并被孔36弯曲，延伸远离孔36并向远侧延伸到针18的管腔中。在一个实施例中，推动器34的运动在导丝32的弯曲部分上施加摩擦力，以便使导丝的远侧部分推进或缩回。当推动器34向远侧移动时，导丝32被向远侧推进推动器34的移动距离的两倍距离。这方便地提高了导丝推进的效率，这在这种医疗装置的操作中是期望的。
壳体
图4A和图4B是本发明的导管插入工具的壳体40的侧视图。壳体40包括第一部42和与第一部42接合的第二部44，第一部42包括远侧部分42A和近侧部分42B，其中第一部42的远侧部分42A被构造成能够相对于第二部44向远端滑动，以释放第一部42和第二部44之间的接合46。
在一个实施例中，第一部42的近侧部分42B固定到第二部44。可选地，第一部42的近侧部分42B经由可分离构造，例如卡扣接头、销接头、铆钉接头、带扣等，与第二部44接合。需要超过阈值大小的力以释放第一部42的近侧部分42B和第二部44之间的可分离接合，以防止壳体意外分离。在其它实施例中，第一部42的近侧部分42B和第二部44彼此不可分离或形成一体件。
在一个实施例中，如图4C和图4D所示，钩46A设置在壳体的第一部42的远侧部分42A的内表面上。钩46A具有朝向壳体40的近端延伸的尖端。槽46B设置在第二部44上。当第一部42和第二部44接合时，槽46B接收钩46A，并且当第一部42的远侧部分42A向远侧滑动使得第一部42从第二部44释放时，钩46A从槽46B释放。
返回到图4A，壳体40的第一部42和第二部44通过由钩46A和槽46B形成的接合46以及第一部42的近侧部分42B与第二部44之间的接合彼此接合。在箭头所指的方向上，第一部42的远侧部分42A可以相对于壳体40的第二部44向远侧滑动。第一部42的远侧部分42A的远侧滑动导致钩46A相对于槽46B的远端运动。当钩46A的尖端到达如图4B所示的位置时，钩46A可以与槽46B分离，使得接合46被释放，并且第一部42的远侧部分42A和第二部44可以在相对于彼此的垂直方向上分离。
应当注意的是，虽然图4A-4D仅示出一对钩46A和槽46B，但是在一个实施例中，本发明的壳体40包括两个钩和两个槽。为了更好地稳定接合46，作为最佳实施例，在远侧部分42A的内表面上平行布置两个钩，并且相应地，以与两个钩相同的方式在第二部44上设置两个槽。在本发明的精神范围内，钩和槽的其它数量和布置是可能的。
如图4A和4B所示，在一个实施例中，基部48设置在壳体40的第二部44的内表面上，用于保持针18的近侧端部。针18的近侧端部被固定至壳体。在一个实施例中，基部48包括孔，以允许导丝经由该孔延伸到针18的管腔中。
如图4D所示，在一个实施例中，凹槽45设置在第一和第二部42/44中的至少一个的内表面上，凹槽45的内部宽度足够宽以允许导管在轴向上自由移动，并且足够窄以限制垂直于轴向方向的导管的运动。也就是说，当彼此接合时，壳体的第一部和第二部提供对针18的远侧部分的支撑，其在针18被插入患者身体或从患者身体抽出时限制针18的摆动。
在一个实施例中，远侧部分42A和近侧部分42B在远侧部分42A的远侧运动之前或之后总是彼此连接。该连接可以通过弹性或可折叠或铰接连接形成。弹性或可折叠连接的实例可以是铰链、弹簧或其它柔性件。
在其它实施例中，第一部42的远侧部分42A可以在远侧部分被向远侧滑动之后与第二部44分离，以释放第一部42和第二部44之间的接合。
连续参考图4A-4D。在另一个实施例中，第一部42的远侧部分42A的近侧端部包括被夹在第一部42的近侧部分42B和第二部44之间的结构49，结构49的运动被限制在由第一部42的近侧部分42B和第二部44形成的腔内。具体地，在一个实施例中，结构49包括从远侧部分42A的近侧端部向近侧延伸的柔性片49A和从柔性片49A的端部的两侧垂直延伸的两个壁49B。在一个实施例中，在远侧部分42A向远侧滑动一定距离之后，结构49被基部48阻挡，以防止第一部42的远侧部分42A的进一步远侧运动。该一定距离也是允许钩46A从槽46B中释放的钩46A的远侧移动距离。
在一个实施例中，远侧部分42A的结构49的片49A和两个壁49B与从基部48延伸的脊部接合。脊部用作是用于结构49的导轨，其允许沿着脊部的远侧移动，而且还限制了结构49在远侧运动期间的摆动。
在一个实施例中，结构49由第二部44的基部48和第一部42的近侧部分42B的内表面夹住。这防止远侧部分42A与壳体的其余部分脱离，并且允许远侧部分42A相对于第二部44以一定角度开启-关闭运动。这样的机构避免了使用后壳体脱落，有利于医疗安全(例如，防止针刺和/或血液污染)和用户体验。
图5A-5C是本发明的导管插入工具的壳体50的侧视图。如图5A所示，壳体50包括第一部52以及与第一部52接合的第二部54，第一部52包括远侧部分52A和类似于图4A和4B所示的近侧部分42B的近侧部分。第一部52的远侧部分52A的近侧端部56被构造成能够轴向地锁定到第二部54，并且第一部52的远侧部分52A被构造成当第一部52的远侧部分52A的近侧端部56与第二部54之间的锁定被释放时能够相对于第二部54向远侧滑动，以便释放第一部52和第二部54之间的接合46。
继续参考图5A，其中在一个实施例中，如部分放大视图“A”所示，第一突起56A从远侧部分52A的近侧端部56朝向第二部54延伸，并且第二突起56B从第二部54向第一部52的远侧部分52A的近侧端部56延伸。在图5A中，第一部52的远侧部分52A的近侧端部56是柔性的并且被朝向第二部54偏置(例如通过滑块58)，并且第一突起56A相对于第二突起56B处于近侧，由此第一部52的远侧部分52A的近侧端部56轴向地锁定到第二部54，使得第一部52不能相对于第二部54轴向和向远侧移动。
图5B是图5A所示的壳体的第一部52的远侧部分52A的侧视图。图5B所示的远侧部分52A的近侧端部56处于自然的、无偏置的状态，并且呈向近侧向上地稍微倾斜的斜面的形式。该斜面可以具有连续的厚度。可选地，斜面的厚度可以向远侧逐渐增加或减小，在第一突起56A的位置处达到的最小或最大厚度(不考虑第一突起56A本身的高度)。斜面具有的这种变化厚度可以有助于改变滑块58对斜面施加的力的大小和滑块58与斜面之间的摩擦力。
图5C是当第一部52的远侧部分52A的近侧端部56与第二部54之间的锁定被释放时壳体50的侧视图。在一个实施例中，当滑块58向远侧移动时，滑块58施加在第一部52的远侧部分52A的近侧端部56上的力减小，并且近侧端部56逐渐地不被偏置，因此第一突起56A相对于第二突起56B向上移动。当滑块58向远侧移动到如图5C所示的特定位置时，第一突起56A移动直到到达第二突起56B不再阻挡第一突起56A的远侧移动的位置，因此第一部52的远侧部分52A的近侧端部56和第二部54之间的锁定被释放。
类似于图4A-4D中的壳体40，在如图5D和5E所示的一个实施例中，钩46A设置在壳体50的第一部52的远侧部分52A的内表面上，并且槽46B在对应于钩46A的位置设置在壳体50的第二部54上。钩46A可以是首先从壳体50的第一部52的远侧部分52A的内表面垂直地突出并且然后水平地且向近侧地延伸的形式，如图5F所示。当第一部52和第二部54接合时，槽46B接收钩46A，并且当第一部52的远侧部分52A的近侧端部56与第二部54之间的锁定被释放并且第一部52的远侧部分52A向远侧滑动时，钩46A从槽46B释放，使得第一部52可以从第二部54释放。
图5F是插入工具的侧视图，示出了当第一部52的远侧部分52A和第二部54之间的接合被释放时的状态。在一个实施例中，第一部52的远侧部分52A的近侧端部56包括被夹在第一部52的近侧部分(图5F中未示出)和第二部54之间的结构56C，结构56C的运动被限制在由第一部52的近侧部分和第二部54形成的腔内。具体地，在一个实施例中，结构56C类似于如图4A-C所示的结构49。在一个实施例中，在远侧部分52A向远侧滑动一定距离之后，结构56C被基部48阻挡，以防止第一部52的远侧部分52A的进一步远侧移动，其中所述一定距离也是允许钩46A从槽46B释放的钩46A的远侧移动距离。
在第一部52的远侧部分52A的近侧端部56与第二部54之间的这种锁定机构可以有效地防止临床医生的可能导致壳体的第一部的远侧部分的远侧运动的不经意的操作，并因此防止壳体的不期望的分离。此外，在一个实施例中，除了释放第一部52的远侧部分52A和第二部54之间的轴向锁定之外，滑块58的远侧运动还构造成同时推进导丝，并且这种构造增加了操作效率和安全性。
针的尖端保护
图2和图6A示出了本发明的插入工具10的一个实施例的内部结构。具体地，图2是没有壳体12的第一部12A的插入工具10的俯视图。在一个实施例中，本发明的插入工具10包括壳体12、附接到壳体的导轨14、从壳体12向远侧延伸的针18、导管推进组件20、导丝推进组件30，其中导管推进组件20包括导管22、导管套24和可分离地附接到导管套24的安全帽26。
除了图2所示的状态之外，图6A示出了安全帽26向远侧滑动到安全帽26被锁定到导轨14的位置。在一个实施例中，安全帽26被构造为当向远侧滑动到将针18的尖端隔离在安全帽26内的位置时被锁定到壳体12。要注意的是，由于导轨14可以是壳体的一部分或者附接到壳体，所以当安全帽26锁定到导轨14上时，安全帽26也可以被认为被锁定到壳体12。图6A清楚地示出了安全帽26被锁定到壳体并且针的尖端被隔离在安全帽26内的位置。在该位置，安全帽26和针18之间的相关运动受到限制，以防止针的尖端再次暴露。
图6B示出了当安全帽26处于如图6A所述的位置时，导管套24与安全帽26分离的视图。
如图6A和6B所示，在一个实施例中，当安全帽26滑动到将针18的尖端18C隔离在安全帽26内的位置时，安全帽26在位置60处被锁定到壳体12，并且针18的尖端18C隔离在安全帽26内。
图6C示出了本发明的一个实施例的安全帽26的结构。安全帽26包括第一部26A和第二部26B。结合图2、图6A和图6B来观察，在一个实施例中，安全帽26的第一部26A包裹针18，并且安全帽26的第二部26B可滑动地附接到导轨14。具体地，在一个实施例中，安全帽26的第一部26A包括通过第一部26A延伸的管腔27，其包含和包裹针18。
在一个实施例中，安全帽26的第一部26A具有两个指状件62。在一个实施例中，这两个指状件62在它们之间具有包裹针18的狭缝。在另一个实施例中，三个、四个或甚至更多个指状件是可能的。在另一个实施例中，指状件62是条带状或柱状。
图7A和7B示出了本发明的一个实施例的导管套24和安全帽26之间的接合。通过将指状件62上的突起64插入设置在导管套24上的凹部66中而形成该接合。
参考图7A，在一个实施例中，指状件62构造成在针18的柄延伸穿过安全帽26的第一部26A时向导管套24的内表面径向偏置。即，当安全帽26的第一部26A包裹针柄时，指状件62被针18略微向外偏置/挤压。径向偏置的指状件62将它们的突起64插入凹部66，并且来自针18的压力帮助固定突起64向凹部66的插入，从而实现导管套24与安全帽26之间的接合。
参考图7B，在一个实施例中，指状件62构造成当安全帽26向远侧滑动到隔离针18的尖端的位置时从偏置位置释放。也就是说，当失去来自针的压力时，指状件62朝向导管套24的管腔的轴线会聚，并且突起64可被从凹部66拉出，因此导管套24可以与安全帽26分离。
参考图7A，在一个实施例中，指状件62构造成当针的柄延伸穿过安全帽26的第一部26A时以及当安全帽26向远侧滑动到隔离针的尖端的位置时保持在相同位置。也就是说，指状件62保持在相同位置，并且不管是否有来自针18的压力都基本上不被偏置。不管针是否延伸穿过由指状件形成的中空圆筒，该中空圆筒的外径不会改变。然而，来自针18的压力有助于突起64和凹部66之间的插入。
参考图7B，在一个实施例中，当失去来自针的压力时，指状件62保持在与受到针18偏置/挤压时相同的位置。在这种情况下，当插入工具的使用者尝试将安全帽26拉离导管套24时，突起64被拉出凹部66。
在一个实施例中，每个指状件62都包括突起64，并且对应数量的凹部66设置在导管套的内表面上。在一个实施例中，每个指状件62可以包括一个或多个突起64。
现在参考图6C。突起64的近侧面在近侧面的从指状件62延伸的位置处相对于指状件62的表面形成钝角。也就是说，突起64的近侧面是斜面，当指状件62没有被针18偏置/挤压时，该斜面允许突起64被拉出凹部66。
参考图8A-C，安全帽26的第二部26B是杆81，其沿着导轨14滑动。在一个实施例中，杆81包括从杆81的面向导轨14的表面84的两侧垂直延伸的两个垂直壁82。这两个垂直壁82中的每个都具有水平部分，其具有突起86，该突起在安全帽26向远侧滑动到将针18的尖端隔离在安全帽26内的位置时被锁定在导轨14上形成的凹口88中，以便将安全帽26锁定到壳体12。
为了清楚地示出杆81的结构，参考图8C，图8C是垂直于安全帽26的管腔的轴线的平面的截面图。在一个实施例中，面向导轨14的杆的表面84包括两个垂直壁82，并且杆81在表面84的相反侧连接到安全帽26的第一部26A。两个垂直壁82中的每一个都具有水平部分，其具有突起86。这里，水平部分基本上平行于表面84，并且在一个实施例中，垂直壁82在杆的整个长度上延伸，并且水平部分比杆的整个长度短。在另一个实施例中，垂直壁82仅在杆的一部分长度上延伸，并且水平部分比垂直壁82的长度短。
如图8B所示，在一个实施例中，凹口88形成在设置在导轨上的两个突出的凸起88A和88B之间。在另一个实施例中，近侧的凸起88A在近侧具有倾斜斜面88C，并且在远侧基本上垂直于导轨的表面。在一个实施例中，远侧凸起88B比近侧凸起88A从导轨14的表面升起得更高。当突起86在近侧凸起88A的倾斜斜面88C上滑过时，杆的两个突起86之间的距离沿倾斜斜面88C增加，并且两个突起86之间的张力也逐渐增大。当突起86落入由突出的凸起88A和88B形成的凹口中时，突起86的进一步移动被突出的凸起88B的近侧面和突出的凸起88A的远侧面阻挡，因此安全帽26被锁在导轨14上。
在一个实施例中，当安全帽26被锁定到壳体12时，例如当杆的突起86落入凹口88中时，插入工具的使用者(例如临床医生)感觉到触感。在一个实施例中，除了触觉之外还产生可听见的声音。
隔挡件
参考图9，在一个实施例中，插入工具包括至少一个隔挡件90，以在针插入并且导管被推进或离开患者的身体时防止血液暴露。在一个实施例中，隔挡件90可以设置在插入工具内的管腔中。例如，隔挡件90可以放置在插入工具的导管套24的管腔中，和/或可以放置在插入工具的安全帽26的管腔中。
在一个实施例中，隔挡件90设置在导管套24的管腔内。在一个实施例中，隔挡件100设置在安全帽26的第一部分26A中。在一个实施例中，隔挡件110设置在安全帽26的第一部分26A的管腔内。要注意的是，隔挡件也可以设置在插入工具的其他元件中，例如导管套24的分支管中。隔挡件26的尺寸和形状被构造成适合对应的元件或该元件的管腔，并且每个隔挡件的尺寸和形状可以相同或不同。
图10A-D示出了本发明的一个实施例的隔挡件90。参考图10A，在一个实施例中，隔挡件90包括圆柱形主体92和从主体92的顶面94A的中心部延伸的第一突起94。在一个实施例中，圆柱形主体92的厚度被构造成小于针18的尖端和凹口之间的距离，以便减小隔挡件90和针18之间的摩擦。
如图10B所示，隔挡件90具有沿着隔挡件的纵向轴线形成在隔挡件90内的狭缝96。在一个实施例中，狭缝96形成在第一突起内。在一个实施例中，狭缝96延伸穿过隔挡件。具体地，狭缝96可以部分地或全部地延伸穿过圆柱形主体92和突起。在一个实施例中，当针18延伸穿过狭缝96时，狭缝96被扩大，并且当针18从隔挡件90中抽出时，狭缝96被关闭。当针刺穿整个隔挡件时，狭缝96因此延伸贯穿隔挡件。作为优选实施例，为了确保隔挡件90的密封性能，狭缝96初始不会穿过隔挡件90的整个厚度，因此当组装过程中针刺穿隔挡件90时，隔挡件90将紧紧包裹针并且围绕针提供紧密的密封。作为另一个实施例，隔挡件90形成为没有贯通的狭缝，并且当针刺穿隔挡件90时，隔挡件90紧密地包裹住针，并且可以围绕针提供比具有狭缝的构造更紧密的密封(假设构造在所有其他方面是一样的)。
在一个实施例中，在隔挡件90安装在导管插入工具的管腔中之前，隔挡件90的主体92的外径稍微大于该管腔的内径。具体地，隔挡件90的主体92的外径大于导管套24的内径。当隔挡件90组装在导管套24的管腔中时，导管套24的内表面与隔挡件90紧密接触，从而提供更好的密封。
在一个实施例中，隔挡件的第一突起94的形式是从主体92的顶面94A渐缩的圆形截头锥体，如图10B所示。并且该圆形截头锥体与主体92同轴。在一个实施例中，第一突起94与主体92成一体。
在一个实施例中，隔挡件90的顶面94A在外围处被倒了圆角。在一个实施例中，圆形截头锥体的顶面在外围处被倒了圆角。
在一个实施例中，本发明的隔挡件90还包括从主体92的与顶面94A相对的底面98A的中心部延伸的第二突起98。
在一个实施例中，如图10A和10B所示，第二突起98的形式是从底面98A渐缩的圆形截头锥体。并且该圆形截头锥体与主体92同轴。在一个实施例中，第二突起98与主体92成一体并形成一整体。在另一个实施例中，第二突起98为嵌入主体92的中心的圆柱体的形式。在另一个实施例中，第一突起94和第二突起98形成嵌入主体92的中心的圆柱体。在一个实施例中，狭缝96在由第一突起94或第二突起98形成的圆柱体中部分地延伸。在另一个实施例中，狭缝96在整个圆柱体上延伸。
在一个实施例中，第一和第二突起的尺寸和形状相同。在另一个实施例中，第二突起98低于第一突起94。当导管套24的管腔在隔挡件90的一侧充满流体(例如血液)时，面对流体的第一或第二突起的侧表面承受来自流体的向心压力，并且在针延伸穿过隔挡件时更紧密地包裹针，或者如果已经形成穿过隔挡件的狭缝时更紧密地关闭该狭缝，从而提供更好的流体密封。
图10C和10D示出了组装在导管套24中的隔挡件90。在一个实施例中，如图10C所示，隔挡件90设置在导管套24的管腔101的远端，该管腔接收安全帽26。管腔101具有台阶101A，在台阶101A处管腔101的内径向远侧下降。在台阶101A的近侧，隔挡件90的主体92的外径足够大以提供与导管套24的管腔101的内表面的流体密封接触。在台阶101A的远侧，隔挡件90的第一突起94延伸到台阶101A远侧的管腔101中。要理解，隔挡件也可以设置在导管套24的管腔101内的其它位置。在如图10D所示的另一个实施例中，隔挡件90夹在形成在导管套24的管腔101的内表面中形成的两个台阶101A和101B之间。
在一个实施例中，隔挡件90由聚异戊二烯、硅橡胶、聚氨酯、丁基橡胶或胶乳制成。
图11A和11B示出了本发明的一个实施例的隔挡件100。参考图11A，在一个实施例中，隔挡件100包括圆形端部102和从端部102的外围延伸的管状部104。在一个实施例中，隔挡件100为管状形状，具有在隔挡件100的远端处的封闭端(圆形端部102)和隔挡件100的近侧端部处的开口端。具体地，在一个实施例中，端部102是圆形薄膜，并且管状部104沿垂直于端部102的平面的方向从膜的周边延伸。
在一个实施例中，隔挡件100还包括从圆形端部102的与管状部104相对的表面的中心部延伸的突起106。在一个实施例中，突起106为圆柱体的形式。在另一个实施例中，突起106是从底面渐缩的圆形截头锥体的形式。突起106与圆形端部102同轴。在一个实施例中，突起106、圆形端部102和管状部104形成一体件。
类似于隔挡件90，隔挡件100的端部102可以形成有或不具有狭缝。
图11B示出了组装在安全帽26的远侧部上的隔挡件100。在一个实施例中，隔挡件100设置在安全帽26的指状件上，其中管状部104的侧壁包括至少一个凹部108，其允许设置在指状件上的突起延伸穿过凹部108。在一个实施例中，设置在管状部104上的凹部108的数量和位置对应于设置在安全帽26的指状件上的突起的数量和位置。如上所述，安全帽的指状件在指状件的远侧部彼此分离，并且被构造成在包裹针时径向偏置，并且当针从其中被拉出时向中心收敛。隔挡件100被构造为盖住/覆盖指状件，以便提供密封以防止血液从安全帽的指状件泄漏。
此外，当安全帽26的指状件62完全或部分地位于导管套24的管腔101内时，例如如图7B、图9或图10D所示，设置在指状件62上的隔挡件100增强了在安全帽26和导管套24之间的密封。且隔挡件100在安全帽26和导管套24之间提供适当的摩擦力，并且该摩擦力需要使用者/临床医生在安全帽26滑动到针的尖端隔离在安全帽内的锁定位置时施加力以分离导管套24和安全帽26。
此外，作为另一个实施例，当安全帽26和导管套24连接时，设置在安全帽26的指状件上的隔挡件100和设置在导管套24的管腔101中的隔挡件90彼此接触。具体地说，在一个实施例中，当安全帽26的指状件部分完全插入导管套24的管腔时，隔挡件90的主体92或突起94/98与隔挡件100的突起106或端部102紧密接触。这样的构造可以防止在针的尖端穿过隔挡件90和100时的血液泄漏，并且因此当安全帽26和导管套24彼此分离时防止血液暴露。
在一个实施例中，隔挡件100由聚异戊二烯、硅橡胶、聚氨酯、丁基橡胶或胶乳制成。
在一个实施例中，如图11B所示，导管插入工具10还包括设置在第一部26A的管腔中的隔挡件110。具体地，作为实施例，隔挡件110为圆柱形。在一个实施例中，隔挡件110的厚度被构造为小于针18的尖端和凹口之间的距离，以便减小隔挡件110和针18之间的摩擦。
类似于隔挡件90，隔挡件110可以形成有或不具有狭缝。
在一个实施例中，在隔挡件110安装在管腔中之前，隔挡件110的外径大于安全帽26的第一部26A的管腔的内径。
在一个实施例中，隔挡件110设置在第一部26A的管腔的近侧端部中，以便与隔挡件100和管腔101一起形成闭合腔。因此，闭合腔防止当针的尖端被隔离在安全帽26的封闭腔内时血液泄漏。
在一个实施例中，隔挡件110由聚异戊二烯、硅橡胶、聚氨酯、丁基橡胶或胶乳制成。
导丝推进组件
返回参考图2或图3A，在一个实施例中，插入工具10包括用于将导丝32向远端推进到患者的脉管系统中或者从患者的脉管系统向近端抽出该导丝的导丝推进组件30。在一个实施例中，导丝推进组件30还包括推动器34，用于操作导丝32的运动以准备导管22的推进。
图12A和12B示出了在导丝32推进之前和之后的导丝推进组件30的截面图。在一个实施例中，导丝32的至少一部分设置在针18的管腔内。导丝32的一端固定在壳体12上的锚定点120上，并且导丝32从锚定点120向近侧延伸，经由导轨122A的第一部进入推动器34的孔36，远离孔36延伸，向远侧延伸进入导轨122B的第二部，并且最终穿过针座延伸到针18的管腔中。
在一个实施例中，导轨122A-B包括在导管插入工具的纵向方向上与孔36对准的凹槽。凹槽用于限制导丝32并防止导丝32在操作过程中不期望的晃动或弯曲。具体地，作为实施例，锚定点120和导轨122A的第一部设置在壳体12的第一部12A的内表面上。锚定点120、导轨122A的第一部和推动器34的孔36的上部开口布置成直线，这允许导丝32从锚定点120直线地延伸到孔36。导轨122B的第二部设置在壳体12的第二部12B的内表面上。孔36的底部开口、导轨122B的第二部和针18的近侧端部布置成直线，这使得导丝32能够从孔36直线地延伸到针18的管腔中。在另一个实施例中，导轨122A-B的至少一部分是管道。
图12A示出了在操作之前的导丝推进组件30的构造，其中推动器34定位成靠近壳体的近侧端部。当推动器34向远侧移动到靠近针座的位置时，如图12B所示，导丝32向远侧推进推动器34的移动距离的两倍的距离。
图13A-13C示出了推动器34的结构。图13A是推动器34的一个实施例的立体图，其中推动器34包括推动块130和滑块132。在一个实施例中，推动块130包括从该推动块130的顶面到底面延伸穿过该推动块130的孔36。
图13B是推动块130的截面图，且图13C是推动块130的立体图。如图13B和13C所示，推动块130包括限定孔36的四个侧壁。在一个实施例中，孔36的四个侧壁包括平坦曲线形式的第一侧壁134A和与第一侧壁相对的直的第二侧壁134B。第一侧壁134A和第二侧壁134B之间的最小距离足够宽以允许导丝32的自由纵向移动并且足够窄以限制导丝32的摆动。在另一个实施例中，第二侧壁134B也是平坦曲线的形式，其中第二侧壁134B的平坦表面平行于第一侧壁134A的平坦表面。在一个实施例中，另外两个侧壁是直的。
返回参考图2和图13A，在一个实施例中，滑块132连接到推动块130，推动块130设置在壳体12的内部，并且滑块132部分地设置在壳体12的外部。在一个实施例中，在壳体的第二部12B和壳体的第一部12A的近侧部之间形成有狭缝，该狭缝夹住推动块130和滑块132之间的连接部分，并且允许推动器34相对于壳体12滑动。
图14A和14B示出了本发明的导丝推进组件140的另一实施例。在一个实施例中，导丝推进组件140包括轮142和齿轮144，其中齿轮144同轴地固定到轮142。齿轮144的旋转同步地驱动轮142的旋转。在一个实施例中，导丝32围绕轮142的外径部分地卷起。
在一个实施例中，导丝推进组件140还包括齿条146，其通过齿条146的齿与齿轮144的齿之间的接合与齿轮144接合。在一个实施例中，齿条146的远端可滑动地附接到设置在壳体上的导轨。齿条146沿着导轨的滑动运动驱动齿轮144的旋转和轮142的旋转，并且导丝32被相应地围绕轮142驱动。
在一个实施例中，导丝推进组件140还包括至少一个惰轮148，用于将导丝32限制在轮142的外围表面上。在一个实施例中，轮142的至少外围表面被构造成提供足够的摩擦力来防止轮142和导丝32之间的打滑。这可以通过外围表面的特殊处理或通过选择形成表面的合适材料来实现。
在一个实施例中，导丝推进组件140还包括用于引导导丝32的运动的管道导轨。
导丝推进组件140的推进效率取决于齿轮144和轮142的直径之间的比率。例如，如果齿轮144和轮142的直径之比为1:3，那么齿条146的滑动距离与导丝的移动距离之比也为1:3。
操作步骤
图4A-5C描绘了操作插入工具10以将导管22置于患者的脉管系统中的各个阶段。为了清楚起见，各个阶段被描绘为没有实际插入到所示的患者中。利用图2所示的结构的插入工具10，抓握插入工具10的使用者首先在适当的插入位点引导针18的远侧部穿过病人的皮肤并且进入皮下血管。通过“窜血(blood flash)”，即由于血液从针18的中空内部由凹口流出而在针18的外径和导管22的内径之间存在血液，来确认已实现合适的血管进入是显而易见的。注意，在一个实施例中，当血管被进入时，由于血液从针18进入壳体导致的安全帽26中存在的血液用作辅助窜血指示器。
在确认针进入血管之后，使用者操作导丝推进组件30或140。在一个实施例中，对于图12A-13C所示的导丝推进组件30，推动器34被使用者的手指向远侧滑动，以向远侧推进初始设置在中空针18内的导丝32。在另一个实施例中，对于图14A-14B所示的导丝推进组件140，齿条146由使用者的手指向远侧滑动，以向远侧推进导丝32。导丝向远侧的推进继续直到推动器34已经向远侧滑动其整个行程长度，导致导丝32的预定长度延伸超过针18的远端。在一个实施例中，当推动块130接触针座时，防止了推动器34的进一步的向远侧推进。
一旦导丝32已经完全延伸到患者的血管内，则使用者操作导管推进组件20，其中导管套24由使用者向远侧推进，以使导管22在针18和导丝32上向远侧滑动并经由插入位点进入患者的脉管系统。在这个阶段，通过壳体的远侧部防止了导管套和导管的进一步向远侧运动。然后使用者可以相对于壳体的第二部滑动壳体的第一部的远侧部分，以释放两个壳体部之间的接合。释放后，允许导管套和导管进一步向远侧移动。要注意的是，在导管套24向远侧滑动的过程中，由于安全帽26初始与导管套24接合，所以安全帽26也随导管套24滑动。
在导管22、导管套24和安全帽26从壳体释放之后，使用者可进一步使导管套24向远侧推进，并将针18从患者体内取出。可以同时或相继操作这两个运动。当安全帽被锁定到锁定点并且针的尖端被隔离在安全帽内时，导管套和安全帽相对于针或壳体向远侧的运动被停止。
当针的尖端从安全帽的指状件中抽出并且停留在安全帽的第一部的管腔内时，导管套24可由使用者自由地与安全帽分开。如上所述，导管帽和安全帽中的隔挡件防止患者的血液暴露。然后导管22保留在患者的身体内，导管套24保持靠近插入位点，并且可以移除壳体12、针18、安全帽26和导丝推进组件。
在一个实施例中，本发明的插入工具10可以包括帽或其他保护装置，其在使用之前可移除地附接到插入工具，以保护针和导管。
在不脱离本公开的精神的情况下，本发明的实施例可以以其他具体形式实施。所描述的实施例在所有方面应被认为仅仅是说明性的而不是限制性的。因此，实施例的范围由所附权利要求而不是前面的描述来指示。在权利要求的等同物的含义和范围内的所有变化将被包括在其范围内。

Claims (17)

1.一种导管插入工具，包括：
壳体，导管的至少一部分初始设置在所述壳体中；
从所述壳体向远侧延伸的针；
沿着所述针可滑动的安全帽，其被构造成当向远侧滑动到将所述针的尖端隔离在所述安全帽内的位置时被锁定到所述壳体；
导管套，所述导管套与所述安全帽连接，其中当所述安全帽在向远侧滑动到隔离所述针的所述尖端的位置而被锁定到所述壳体上时，所述安全帽与所述导管套分离，并且其中所述导管的近端连接到所述导管套，
其中所述壳体包括：
第一部，包括远侧部分和近侧部分；和
与所述第一部接合的第二部，其中所述第一部的所述远侧部分构造成能够相对于所述第二部向远侧滑动以释放所述第一部和所述第二部之间的接合。
2.根据权利要求1所述的导管插入工具，其中，所述安全帽包括包裹所述针的第一部和可滑动地附接到导轨的第二部，所述导轨是所述壳体的一体部分或固定到所述壳体。
3.根据权利要求2所述的导管插入工具，其中，当向远侧滑动到将所述针的所述尖端隔离在所述安全帽内的所述位置时，所述安全帽通过被锁定至所述导轨而被锁定到所述壳体。
4.根据权利要求1所述的导管插入工具，其中，所述安全帽的所述第一部包括至少两个指状件，所述至少两个指状件构造成当所述针的柄延伸穿过所述安全帽的所述第一部时向所述导管套的内表面径向偏置以及当所述安全帽向远侧滑动到隔离所述针的所述尖端的所述位置时从所述偏置位置释放。
5.根据权利要求4所述的导管插入工具，其中，所述至少两个指状件中的每一个包括突起，当所述针的柄延伸穿过所述安全帽的所述第一部且所述至少两个指状件朝向所述导管套的所述内表面径向偏置时，所述突起插入设置在所述导管套的所述内表面上的凹槽中。
6.根据权利要求1所述的导管插入工具，其中，所述安全帽的所述第一部包括至少两个指状件，当所述针的柄延伸穿过所述安全帽的所述第一部以及当所述安全帽向远侧滑动到隔离所述针的所述尖端的所述位置时，所述至少两个指状件保持在相同的位置。
7.根据权利要求6所述的导管插入工具，其中，所述至少两个指状件中的每一个包括突起，所述突起插入到设置在所述导管套的内表面上的凹部中。
8.根据权利要求5或7所述的导管插入工具，其中，所述突起的近侧在所述近侧从所述指状件延伸的位置处相对于所述指状件的表面形成钝角。
9.根据权利要求1所述的导管插入工具，其中，当所述安全帽滑动到将所述针的所述尖端隔离在所述安全帽内的所述位置时，所述安全帽在第一位置处被锁定到所述壳体，并且所述针的所述尖端被隔离在所述安全帽的第二位置内，所述第一位置向远侧与所述第二位置间隔开。
10.根据权利要求1所述的导管插入工具，其中，当所述安全帽被锁定到所述壳体时，为临床医生产生触感。
11.根据权利要求2所述的导管插入工具，其中，所述安全帽的所述第二部是杆，所述杆包括分别从所述杆的面向所述导轨的表面的两侧延伸的两个垂直壁，所述两个垂直壁中的每一个具有带突起的水平部分，所述突起在所述安全帽向远侧滑动到将所述针的所述尖端隔离在所述安全帽内的所述位置时被锁定在所述导轨上形成的凹口内，以便将所述安全帽锁定到所述壳体。
12.根据权利要求11所述的导管插入工具，其中，所述凹口形成在设置在所述导轨上的突出的两个凸起之间。
13.根据权利要求12所述的导管插入工具，其中，所述两个凸起中的近侧凸起在近侧具有倾斜的斜面，并且在远侧基本垂直于所述导轨的所述表面。
14.根据权利要求12所述的导管插入工具，其中，所述两个凸起中的远侧凸起比所述两个凸起中的近侧凸起从所述导轨的所述表面上升得更高。
15.根据权利要求11所述的导管插入工具，其中，所述垂直壁在所述杆的整个长度上延伸，并且所述水平部分比所述杆的所述整个长度短。
16.一种用于将导管插入患者体内的工具，包括：
壳体，所述导管的至少一部分初始设置在所述壳体中；
从所述壳体向远侧延伸的针，所述导管的至少一部分设置在所述针上；
初始部分地设置在所述针内的导丝；和
用于向远侧推进所述导管的推进组件，
其中所述推进组件包括所述导管、安全帽和导管套，所述安全帽初始设置在所述针上并且构造成当向远侧滑动到将所述针的尖端隔离在所述安全帽内的位置时被锁定到所述壳体，所述导管套与所述安全帽连接，其中当所述安全帽在向远侧滑动到隔离所述针的所述尖端的位置而被锁定到所述壳体上时，所述安全帽与所述导管套分离，并且其中所述导管的近端连接到所述导管套，
其中所述壳体包括：
第一部，包括远侧部分和近侧部分；和
与所述第一部接合的第二部，其中所述第一部的所述远侧部分构造成能够相对于所述第二部向远侧滑动以释放所述第一部和所述第二部之间的接合。
17.根据权利要求16所述的用于将导管插入患者体内的工具，其中，所述壳体的所述第一部和所述第二部的接合被释放，以准备使所述安全帽滑动到将所述针的所述尖端隔离在所述安全帽内的所述位置。
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BR112019018016A2 (pt) 2020-04-28
US11400260B2 (en) 2022-08-02
CN209221279U (zh) 2019-08-09
JP6953541B2 (ja) 2021-10-27
CN108525102A (zh) 2018-09-14
US20200001051A1 (en) 2020-01-02
JP2022000229A (ja) 2022-01-04
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WO2018157339A1 (en) 2018-09-07
CA3054969A1 (en) 2018-09-07
EP3585471A1 (en) 2020-01-01
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EP3585471A4 (en) 2021-03-10
CN114099903A (zh) 2022-03-01

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