CN112386778A - 中线导管放置装置 - Google Patents

中线导管放置装置 Download PDF

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CN112386778A
CN112386778A CN202010830639.8A CN202010830639A CN112386778A CN 112386778 A CN112386778 A CN 112386778A CN 202010830639 A CN202010830639 A CN 202010830639A CN 112386778 A CN112386778 A CN 112386778A
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catheter
housing
actuator
assembly
needle
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S·R·艾萨克森
W·F·哈丁
C·D·谢尔默
D·M·斯泰普
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Becton Dickinson and Co
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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
    • A61M25/06—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
    • A61M25/0105—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
    • A61M25/0097—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
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1585—Needle inserters
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1587—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body suitable for being connected to an infusion line after insertion into a patient
    • 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

Abstract

本申请涉及中线导管放置装置。提供了用于定位导管(特别是中线导管)并且将其插入患者的一种导管插入装置。插入装置包括相对于壳体可移动的致动器组件，用于将导管部署在针上。致动器的逐步运动在导引针上阶段性地推进包括导管的导管组件。导管组件的分度指状物在致动器的远侧推进期间接合致动器本体，并且随着致动器向近侧移动而偏转。装置还包括锁定装置比如按钮、套环、滑动件或接片，锁定装置允许导管相对于针的运动，但是防止导管推进至逐步运动的第一阶段。

Description

中线导管放置装置
优先权
本申请要求2019年8月19日提交的美国临时申请号62/888,946的优先权权益，其全部内容通过引用并入本申请。
技术领域
本申请涉及医疗器械领域，更具体地涉及中线导管(midline catheter)放置装置。
背景技术
中线导管通常被用于胃肠外营养、静脉内(“IV”)补液(fluid replacement)和施用镇痛药与抗生素。使用无菌技术将中线导管插入床边处并且可以将其保持在适当位置数周。插入(静脉穿刺)可以在肘前窝上方和下方在头静脉、贵要静脉或肱静脉中进行。将导管尖端推进3英寸至8英寸，其中尖端终止于腋窝和近侧中央静脉下方。
中线导管的潜在优点是降低频率的用于实验室/重新开始(lab/restart)的反复静脉穿刺、导管相关感染的降低的发生率、延长的植入/留置持续时间、改进的临床结果、患者满意度和相关联的成本节约。将导管尖端放置在上臂中较大直径的静脉(与较小的静脉相比)中提供了改进的药物递送疗法和血液稀释。中线导管可以被用于以较高的流速输注造影剂(contrast media)，这通常通过中央静脉(“CV”)导管(比如外周插入的中央静脉导管(“PICC”)应用)完成。
现有的中线导管装置通常包括整合的(integral)导丝。在针进入静脉后，导丝被推进通过针的内腔并且进入静脉。超声探头(ultrasonic probe)或成像装置经常被用于将针定位在期望的位置中。然后在导丝上将导管推进入静脉。然后，针和导丝从保持在静脉中的适当位置的导管拆卸下并且分离。
这些现有的装置通常需要通过将滑动构件移动入锁定/止动位置而完全部署导丝。为推进导管，使用者必须放下超声探头和使用双手推进导管并且完成手术的最终步骤。这导致损失了静脉的可视化和导管相对于静脉的定位。
导管放置和推进取决于使用一只手将装置保持在静止位置，同时以另一只手操纵导管推进机构，而不使用超声成像辅助导管的适当的放置。一旦导管被完全推进，使用者必须重新定位超声探头以重新建立图像和确认导管的正确放置。操作需要一系列连续的步骤以及专门的训练。手部位置从超声探头至装置并且返回探头的额外的交换增加了手术的复杂度，并且使导管的适当的放置的成功存在风险。
因此，需要一种导管放置装置，其合理化了导管放置涉及的步骤，以及使用单手操作，同时仍提供与目前的导管放置装置相同的功能性。
发明内容
简而言之，本文公开的实施方案涉及提供较长长度的“微型中线”导管的延长的留置外周IV导管(“PIVC”)装置。导管将类似于PIVC被放置，而不需要导丝并且将仅需要单手操作。放置将在超声成像引导下进行，并且可以进入更深的脉管或有助于困难的静脉进入(“DVA”)手术。对于需要中期/长期IV疗法的患者，导管将能够成功地延长留置时间，例如在5天至30天之间。
本文公开了一种导管放置装置，包括：壳体；针，其从壳体的远端延伸；导管组件，其同轴地布置在针上，包括由导管衬套(hub)支撑的导管和安全组件，该安全组件包括第一分度指状物(indexing finger)；和致动器组件，其配置为在第一位置与第二位置之间纵向地转变，致动器组件包括延伸通过壳体中的细长的开口的致动器按钮和致动器本体，该致动器本体包括多个致动器支撑部(abutment)，其中随着致动器组件在第一位置与第二位置之间移动，第一分度指状物接合多个致动器支撑部中的第一致动器支撑部，并且致动器组件以逐步方式向远侧推进导管组件。
在一些实施方案中，第一分度指状物与安全组件整体模制以形成单个结构，第一分度指状物配置为伴随致动器本体从第二位置移动至第一位置而柔性地变形。第一分度指状物由套环(collar)支撑并且形成为与安全组件分开的结构，套环被联接至安全组件，并且第一分度指状物配置为伴随致动器本体从第二位置移动至第一位置而柔性地变形。壳体包括多个壳体接片(tab)，其接合安全组件以防止安全组件的近侧运动。壳体包括多个壳体支撑部，其接合从安全组件延伸的第二分度指状物以防止第二分度指状物的近侧运动。
在一些实施方案中，致动器本体包括限定反向通道的顶壁、第一侧壁和第二侧壁，导管组件沿着纵向轴线通过该反向通道移动。第一侧壁或第二侧壁中的一个包括多个缺口(notch)，其限定多个致动器支撑部。第一侧壁或第二侧壁中的一个包括多个孔口，其限定多个致动器支撑部。壳体包括第一门和第二门，均布置在壳体的远端处并且配置为在打开位置与关闭位置之间枢转地通过水平平面。壳体包括沿着纵向竖直平面结合的第一壳体半部和第二壳体半部，第一门铰接地联接至第一壳体半部，并且第二门铰接地联接至第二壳体半部。
在一些实施方案中，壳体包括第一铰接门，其布置在壳体的远端处并且配置为枢转地通过竖直平面。壳体包括沿着纵向水平平面结合的第一壳体半部和第二壳体半部，第一门铰接地联接至第一壳体半部。在一些实施方案中，导管放置装置进一步包括锁定装置，其在锁定位置与解锁位置之间转变，锁定位置允许导管相对于针的运动并且限制导管组件以逐步方式的远侧推进。导管相对于针的运动被限制为小于在第一致动器支撑部与邻近第一致动器支撑部的第二致动器支撑部之间的纵向距离。导管相对于针的运动被限制为小于在第一致动器支撑部与邻近第一致动器支撑部的第二致动器支撑部之间的纵向距离的一半。导管相对于针的运动被限制为1mm至3mm之间的距离。
在一些实施方案中，锁定装置包括锁定按钮，该锁定按钮包括接合臂，该接合臂具有限定第一直径的第一孔口和限定第二直径的第二孔口，第二直径大于第一直径，第一孔口与第二孔口连通以限定锁孔形状，该锁孔形状接收由其通过的安全组件的锚定部分。锁定按钮在锁定位置与解锁位置之间转变，锚定部分在锁定位置中被布置在第一孔口内并且在解锁位置中被布置在第二孔口内。锚定部分包括从锚定部分的近端径向延伸的凸缘，凸缘限定大于第一直径且小于第二直径的直径，当锁定按钮处于锁定位置时，凸缘抵靠(abutagainst)接合臂。
在一些实施方案中，锁定装置包括锁定套环，其与壳体的外表面可滑动地接合并且在锁定位置与解锁位置之间纵向地转变。锁定套环环绕壳体的纵向轴线，锁定套环在锁定位置中覆盖细长的开口的一部分以限制致动器组件的运动。锁定套环在锁定位置中被布置在致动器按钮与第一突出部(protrusion)之间，并且在解锁位置中被布置在第一突出部与第二突出部之间。锁定装置包括锁定滑动件(slider)，其布置在致动器按钮上，并且当处于锁定位置时垂直于纵向轴线滑动以接合缺口。滑动件的纵向宽度小于缺口的纵向宽度，以允许致动器按钮在锁定位置中的运动并且以逐步方式限制导管组件的远侧推进。
在一些实施方案中，处于解锁位置的锁定滑动件与致动器按钮对准以脱离缺口，并且允许致动器组件在第一位置与第二位置之间移动。锁定装置包括锁定接片，其在锁定位置中被置于致动器组件与壳体之间，限制致动器组件的运动。锁定接片延伸通过在壳体中的狭槽，接片限定小于狭槽的纵向长度的纵向宽度。
还公开了一种插入导管的方法，包括：提供导管插入装置，其具有壳体、从壳体的远端延伸的针、包括致动器按钮和致动器本体的致动器组件、同轴地布置在针上的导管组件和在锁定位置与解锁位置之间可转变的锁定装置，导管组件具有由导管衬套支撑的导管和安全组件，锁定装置准许导管相对于针的运动并且抑制导管的以逐步方式推进；在锁定装置处于锁定位置的情况下致动致动器按钮，以相对于针移动导管；将锁定装置从锁定位置转变至解锁位置；将针插入患者以进入其脉管系统；和将致动器按钮从第一位置致动至第二位置，以相对于针以逐步方式推进导管。
在一些实施方案中，致动器本体包括多个致动器支撑部，并且安全组件包括分度指状物，随着致动器按钮从第一位置移动至第二位置，分度指状物接合多个致动器支撑部中的一个致动器支撑部，并且随着致动器按钮从第二位置移动至第一位置，分度指状物偏转。
还公开了一种在针上推进导管的方法，包括：提供导管放置装置，其包括壳体、导管组件、致动器组件和锁定装置，壳体包括多个壳体接片和从壳体的远端延伸的针，导管组件包括同轴地布置在针上并且接合多个壳体接片中的第一壳体接片的导管，致动器组件配置为在第一位置与第二位置之间移动，以将导管组件从第一壳体接片推进至邻近第一壳体接片的第二壳体接片，锁定装置在锁定位置与解锁位置之间可转变，锁定位置限制导管组件在第一壳体接片与第二壳体接片之间的运动，解锁位置准许导管组件在第一壳体接片与第二壳体接片之间的运动；在锁定装置处于锁定位置的情况下致动致动器按钮，以相对于针移动导管，同时防止导管组件从第一壳体接片推进至第二壳体接片；将锁定装置从锁定位置转变至解锁位置；将针插入患者以进入其脉管系统；和将致动器按钮从第一位置致动至第二位置，以将导管组件从第一壳体接片推进至第二壳体接片。
在一些实施方案中，锁定装置是锁定按钮、锁定套环、锁定滑动件和锁定接片中的一个。壳体包括第一铰接门和第二铰接门，其每个布置在壳体的远端处并且配置为枢转至打开位置以释放导管衬套。
附图说明
将通过参考在附图中展示的本公开内容的具体实施方案呈现本公开内容的更具体的描述。应当理解的是，这些附图仅描绘本发明的典型实施方案，并且因此不应当被视为限制本发明的范围。将通过使用附图利用附加特殊性和细节描述和说明本发明的示例实施方案，其中：
图1示出了根据本文公开的实施方案的导管插入装置的透视图，示出致动器处于起始位置。
图2示出了根据本文公开的实施方案的图1的导管插入装置的透视图，示出致动器处于向前致动位置。
图3示出了根据本文公开的实施方案的图1的导管插入装置的剖面侧视图，示出导管和衬套处于起始位置，并且其中导引针从导管插入装置的远端延伸。
图4A至4B示出了根据本文公开的实施方案的与导管插入装置的壳体分开的导管衬套和安全组件的分解透视图。
图5A示出了根据本文公开的实施方案的导管插入装置的剖面侧视图，示出导管和衬套处于起始位置，并且其中导引针从导管插入装置的远端延伸。
图5B至5E示出了根据本文公开的实施方案的导管衬套和安全组件的各种视图。
图6A示出了根据本文公开的实施方案的导管插入装置的近侧部分的剖面透视图。
图6B示出了根据本文公开的实施方案的图6A的导管插入装置的特写视图。
图6C至6D示出了根据本文公开的实施方案的图6A的导管插入装置的剖面侧视图。
图7A示出了根据本文公开的实施方案的包括锁定装置的导管插入装置的剖面透视图。
图7B示出了根据本文公开的实施方案的图7A的锁定装置的近端视图。
图8A至8D示出了根据本文公开的实施方案的包括锁定装置的导管插入装置的各种视图。
图9A至9C示出了根据本文公开的实施方案的包括锁定装置的导管插入装置的各种视图。
图10A至10D示出了根据本文公开的实施方案的包括锁定装置的导管插入装置的各种视图。
具体实施方式
现在将参考附图，其中相似的结构将配备有相似的附图标记。应当理解，附图是本发明的示例性实施方案的图解和示意性表示，并且既不是限制性的也不必按比例绘制。
关于本文使用的术语，还应当理解，这些术语是出于描述一些具体实施方案的目的，并且这些术语不限制本文提供的概念的范围。序数(例如，第一、第二、第三等)通常用于区分或识别一组特征或步骤中的不同特征或步骤，并且不提供序列或数值限制。例如，“第一”、“第二”和“第三”特征或步骤不必以该顺序出现，并且包括此类特征或步骤的具体实施方案不必受限于这三个特征或步骤。标签比如“左”、“右”、“上”、“下”、“前”、“后”等是为了方便而使用并且不旨在暗示例如任何特定的固定位置、取向或方向。相反，此类标签用于反映例如相对位置、取向或方向。单数形式“一种”、“一个”和“该”包括复数引用，除非上下文另有明确规定。
为了清楚起见，应当理解，词语“近侧”是指相对更靠近使用本文有待描述的装置的使用者的方向，而词语“远侧”是指相对更远离使用者的方向。例如，关于例如本文公开的导管的“近侧”、“近侧部分”或“近端部分”包括当在患者上使用导管时预期靠近使用者的导管的一部分。同样，例如，导管的“近侧长度”包括当在患者上使用导管时预期靠近使用者的导管的长度。例如，导管的“近端”包括当在患者上使用导管时预期靠近使用者的导管的一端。导管的近侧部分、近端部分或近侧长度可以包括导管的近端；然而，导管的近侧部分、近端部分或近侧长度不需要包括导管的近端。也就是说，除非上下文另外暗示，否则导管的近侧部分、近端部分或近侧长度不是导管的末端部分或末端长度。
关于例如本文公开的导管的“远侧”、“远侧部分”或“远端部分”包括当在患者上使用导管时预期靠近患者或在患者体内的导管的一部分。同样，例如，导管的“远侧长度”包括当在患者上使用导管时预期靠近患者或在患者体内的导管的长度。例如，导管的“远端”包括当在患者上使用导管时预期靠近患者或在患者体内的导管的一端。导管的远侧部分、远端部分或远侧长度可以包括导管的远端；然而，导管的远侧部分、远端部分或远侧长度不需要包括导管的远端。也就是说，除非上下文另外暗示，否则导管的远侧部分、远端部分或远侧长度不是导管的末端部分或末端长度。同样，如本文(包括权利要求)使用的词语“包含”、“具有”和“具备”应当具有与词语“包括”相同的含义。
术语“针”和“插管”在本文可以互换地使用以指代具有用于插入受试者上的注射部位的尖锐或斜切端的构件。在一个实施方案中，针可以是细小的、中空的管状构件。
如本文使用的且如图4A所示，纵向轴线平行于导管的轴向长度延伸，侧向轴线正交于纵向轴线延伸，并且横向轴线正交于纵向轴线和侧向轴线延伸。如本文使用的，“轴向”是指沿着或平行于针的纵向轴线，并且“径向”方向是垂直于轴向方向的方向。向前方向是朝向装置的远端的方向。向后方向是朝向装置的近端的方向。除非另外限定，否则本文使用的所有技术和科学术语均具有与本领域普通技术人员通常理解的含义相同的含义。
本文公开的实施方案涉及一种导管放置装置，也被称为“导管插入装置”，其操作简化并且能够单手放置，从而允许使用者同时操作超声探头等以便维持可视化。
参考图1至3，导管插入装置10总体上包括主体或壳体12、导管组件(包括具有导管衬套16的导管14和安全组件46)、导引针18和致动器组件20。致动器组件20形成往复或分度组件和机构，以通过循环(cycling)通过多个阶段以逐步方式在针18的一端上使导管14分度和推进。每个阶段由以下组成：将致动器组件20从第一位置移动至第二位置并且返回第一位置，以在远侧方向上推进导管组件给定的距离。
插入装置10的壳体12具有纵向尺寸，该纵向尺寸具有远端22和近端24。在实施方案中，壳体12可以由两个壳体半部形成，这两个壳体半部通过合适的附接机构结合在一起。例如，第一壳体半部和第二壳体半部可以通过从第一壳体半部突出的一个或多个销(未显示)对准，该一个或多个销可以对应于在第二壳体半部上的一个或多个凹部13(图3)。然而，也可以设想销和凹部的其他配置或类似的附接机构，包括夹、凸耳(lug)、缺口、突出其组合等。壳体12具有在使用期间用于支撑导引针18和导管14并且使得使用者能够在定位导管时操纵装置的尺寸。同样如图3所示，导引针18是中空的并且具有通过柱54或其他支撑件固定在壳体12的内部空腔50内的近端。针18通过开口40从壳体12的远端延伸至在壳体12的远端22远侧的点。
壳体12可以限定形成纵向通道的内部空腔50。在实施方案中，壳体12具有弯曲的侧壁26、平坦的顶壁28和平坦的底壁30。通常布置平坦的底壁30以允许在稳定位置将装置放置在平坦表面上，降低从表面掉落的风险。将理解的是，装置10的形状可以取决于具体用途而不受限制地变化，以便为操作者提供舒适和方便的使用。
在实施方案中，在顶壁28中形成细长的开口32，用于接收由其通过的致动器组件20的一部分。壳体12可以进一步包括尖端部分(“尖端”)34，该尖端部分34具有限定壳体12的远端22的会聚侧。如图4A所示，尖端34的两个铰接门36通过各自的铰接部38被铰接地连接至壁26。铰接门36可以在关闭位置(图1)与打开位置(图4A)之间转变，以进入壳体12的内部空腔50和允许从壳体12移除导管14、导管衬套16、安全组件46或其组合。当铰接门36处于关闭配置时，尖端34中的出口开口40使得导管14和导引针18能够从壳体12的远端延伸。尖端34的会聚表面使得装置能够相对于患者的皮肤以低角度定位，以帮助将导管14和导引针18插入患者，降低导管14扭结或折叠的风险。
导管插入装置10的进一步细节可以在国际专利公开WO2018/170349中找到，该文献通过引用以其全部内容结合到本申请中。
如图3至4B所示，在实施方案中，形成往复或分度组件的致动器组件20在远侧方向上通过一系列阶段以逐步方式推进包括导管14、导管衬套16、安全组件46或其组合的导管组件。每个阶段包括致动器组件20的向后和向前运动。致动器组件20的向前运动使致动器接片76接合导管组件的一部分并且在远侧方向上促动导管组件。在每个向前行程完成时，按钮68被拉回，并且致动器本体66的邻近接片76通过接合导管组件的该部分而准备好用于下一个向前行程。如图3所示，壳体可以包括多个柔性接片(“壳体接片”)60。壳体接片60中的每个接片可以被配置为偏转以允许导管组件或其一部分向远侧行进。一旦导管组件已经向偏转接片60的远侧推进，接片60可以返回未偏转配置。对于每个向后行程，壳体接片60可以接合针安全组件46的本体47，以防止导管组件的近侧运动。如图所示，装置10的起始位置可以是缩回位置(图1)。然而，将理解的是，起始位置也可以是延伸位置(图2)，致动器组件20然后可以通过每个阶段的向后和向前运动循环，以将导管组件向前推进至壳体12的远端。
一旦安全组件本体47和导管衬套16被推进至接近壳体12的远端22的向前位置，铰接门36被枢转至如图4A所示的打开位置，以从壳体12释放导管衬套16和安全组件46。在实施方案中，门36可以通过旋转通过纵向水平平面而转变至打开位置，如图4A所示。推进导管衬套16以接触在门36的内表面上的凸轮(cam)表面81，以将门36转变至打开位置。然后，可以从导管衬套16向近侧撤回壳体12，以从导管14撤回导引针18。安全组件本体47在导引针18的远端56上滑动以封闭尖锐尖端并且防止意外针刺受伤。当通过撤回导引针18致动安全组件46的本体47时，导管衬套16被释放并且与安全组件46分开。然后，可以丢弃具有附接的导引针18和安全组件本体47的壳体12。可选地，密封件形成关闭导管衬套16的近端的阀，以控制血液回流并且允许附接延伸器件(extension set)或其他装置。
如图4B所示，在实施方案中，第一铰接门36A可以铰接地与顶壁28联接，并且第二铰接门36B可以铰接地与底壁30联接。这样，第一铰接门36A或第二铰接门36B中的一个通过旋转通过纵向竖直平面而转变至打开位置，如图4B所示。在实施方案中，第一门36A可以被铰接地联接至壳体12，并且第二门36B可以相对于壳体12以固定关系被联接至壳体12，例如，通过粘附、粘合、焊接等。有利地，这样配置的第二门36可以在尖端34的出口开口40处为针18提供支撑结构。在实施方案中，第二门36B被形成为与壳体12整体模制以形成单个结构。在实施方案中，第一门36A可以相对于壳体12以固定关系联接，并且第二门36B可以被铰接地联接至壳体12。
有利地，门36的铰接机构可以通过遵循装置构造的两侧对称性而简化导管插入装置10的制造和/或组装。例如，如图4A所示，在壳体12由沿着纵向竖直平面结合在一起的两个壳体半部形成的情况下，铰接门36可以与侧壁26联接。类似地，如图4B所示，在壳体12通过沿着纵向水平平面结合两个半部形成的情况下，铰接门36可以与顶壁和底壁28、30联接，以便于制造和组装。
如图5A至5E所示，在实施方案中，壳体12包括多个刚性支撑部(“壳体支撑部”)260。进一步地，致动器本体66包括多个刚性支撑部(“致动器支撑部”)276。如图5B至5E所示，导管组件可以包括一个或多个分度指状物264。分度指状物264可以从安全组件本体47的侧壁延伸并且可以朝向近端成角度。分度指状物264可以被配置为朝向中心轴线向内弹性地偏转，并且可以被偏置到如图5B至5E所示的向外位置。
在实施方案中，安全组件本体47包括从本体47的第一侧延伸的第一分度指状物264A和从本体47的第二侧延伸的第二分度指状物264B。在实施方案中，第一侧和第二侧彼此相对，但是可以设想其他配置。第一分度指状物264A朝向致动器本体66的致动器支撑部276延伸，并且第二分度指状物264B朝向壳体12的壳体支撑部260延伸。
在使用中，致动器组件20的按钮68最初在如图5A所示的缩回位置，并且使用者可以使按钮68向前滑动至第二延伸位置。朝向致动器本体66的近端布置的支撑部276与布置在安全本体47的上表面上的第一分度指状物264A接合，并且使导管组件向前滑动与致动器按钮68的行进距离对应的距离。壳体12的底壁30上的壳体支撑部260被定位成与致动器支撑部276的间距和位置互补。
安全本体47朝向壳体12的远端22的向前运动使第二分度指状物264B偏转，直到其近端向壳体支撑部260的远侧行进为止。向外偏置的分度指状物264B然后接合壳体支撑部260，以将本体47保持在推进位置并且防止本体47朝向壳体12的近端24滑回。本体47的推进运动在固定的导引针18上向前推进导管。
按钮68然后可以朝向缩回位置向后滑动，在该缩回位置，第一分度指状物264A偏转并且在邻近的致动器支撑部276上滑动，以在其上接合面向远侧的接触点。因此，完成了一个阶段循环，该阶段循环推进导管组件逐步推进中的一步。然后，按钮68可以再次向前滑动，以重复第一分度指状物264A和第二分度指状物264B可以接合连续的致动器支撑部276和壳体支撑部260的循环，从而以逐步方式推进导管14。
在实施方案中，按钮68可以通过使用者手动操纵而在缩回位置与延伸位置之间滑动。在实施方案中，导管插入装置10可以包括一个或多个偏置构件(例如，弹簧)以使按钮68和致动器组件在缩回位置与延伸位置之间转变。例如，从延伸位置至缩回位置，或从缩回位置至延伸位置。有利地，偏置构件可以通过将致动器组件自动复位至缩回位置或延伸位置中的一个(准备好在后续步骤中手动操纵致动器组件20)而便于单手使用导管插入装置10。
在实施方案中，如图5B至5C所示，分度指状物264与安全本体47整体模制以形成单个结构。在实施方案中，如图5C至5D所示，分度指状物264形成为与安全本体47分开的结构，并且与其联接。在实施方案中，分度指状物264可以由与安全本体47相同或不同的材料形成。示例性材料包括塑料、聚合物、金属、合金或任何适当的弹性材料。如图5C至5D所示，分度指状物264从套环266延伸。套环266可以至少部分地围绕安全组件本体47的一部分延伸。在实施方案中，套环266从安全组件本体47的第一侧延伸至第二侧。在实施方案中，套环266环绕安全组件本体47，以围绕本体47的纵向轴线。在实施方案中，安全本体47包括一个或多个凹陷，该一个或多个凹陷被配置为保持套环266、分度指状物264或其组合的一部分，以进一步将套环266/分度指状物264紧固至其。
有利地，包括刚性致动器支撑部276、壳体支撑部260和柔性分度指状物264的导管插入装置10需要较少的活动部件。这简化了导管插入装置10的制造和组装，并且提供了导管插入装置10的更稳健的操作。进一步地，通过将分度指状物形成为安全本体47的一部分，进一步简化了导管插入装置10的制造和组装。在分度指状物形成为单独的结构并且可选地由单独的材料形成的可替换方式中，可以更准确地限定或修改弹簧力或偏转阻力的量。这允许导管插入装置10平衡致动器按钮68和导管推进力。
如图6A至6D所示，在实施方案中，导管插入装置10可以包括柔性壳体接片60和刚性致动器支撑部276的组合。还可以设想其他组合，例如，刚性壳体支撑部260和柔性致动器接片76。如本文描述的，导管插入装置10包括壳体12和致动器组件20，该致动器组件20包括联接至致动器本体66的按钮68。致动器本体66向近侧延伸，大致延伸至壳体12的近端，并且包括顶壁228、第一侧壁226A和第二侧壁226B。顶壁228在壳体12的顶壁28下方并且在导管组件(其包括导管14、导管衬套16和安全组件46)上方延伸。第一侧壁226A和第二侧壁226B从顶壁228、壳体12的侧壁26的内部和导管组件的外部延伸。顶壁228、第一侧壁226A和第二侧壁226B可以创建反向通道，导管组件可以沿着纵向轴线在该反向通道内行进。可选地，致动器本体66可以包括圆形(rounded)或倒角(chamfered)部分以紧密配合在壳体12的内部空腔50内。
在实施方案中，第一侧壁226A和第二侧壁226B中的一个可以包括多个缺口274，这些缺口从侧壁的下边缘向上延伸以在缺口274的面向远侧的表面上限定支撑表面276。如图所示，当从侧面轮廓观察时，缺口274限定大致矩形的形状，然而，将理解的是，缺口274还可以限定其他形状比如三角形或半圆形，并且依然在本发明的范围内。在实施方案中，侧壁226A、226B可以包括布置在其中的多个孔口，以限定面向远侧的支撑表面276。
图6B示出了图6A所示的导管插入装置10的近端的特写视图。如图所示，安全组件本体47包括支撑第一分度指状物264A和第二分度指状物264B的套环266。在实施方案中，分度指状物264A、264B还可以与安全本体47形成为单一件，如在此所描述的。套环266接合安全本体47的一部分并且将分度指状物264A、264B支撑在向外偏置的位置。第一分度指状物264A从安全本体47的第一侧部延伸，并且第二分度指状物264B从安全本体47的与第一侧部相对的第二侧部延伸。分度指状物264A、264B与多个缺口274对准，使得分度指状物264的近侧尖端接合面向远侧的支撑表面276。壳体12进一步包括多个壳体接片60，该多个壳体接片60接合安全本体47的下部以防止其近侧运动，如在此所描述的。
在使用中，导管插入装置10包括布置在缩回的起始位置的致动器按钮68，例如，如图5A所示。使用者可以操纵致动器按钮68以在远侧方向上将致动器组件20从起始位置移动至延伸位置(图6C)。如图6C所示，第一侧壁226A的近侧支撑表面276接合第一分度指状物264A，并且第二侧壁226B的近侧支撑表面276(例如，第一支撑表面276a)接合第二分度指状物264B。将致动器组件20推进至延伸位置使得向远侧推进导管组件。向近侧接片60的远侧推进导管组件。接片60在返回未偏转位置以接合安全组件46上的表面64前向下偏转以允许导管组件通过。这防止导管组件的近侧运动。
如图6D所示，致动器组件20然后向近侧从延伸位置移动至缩回的起始位置。当致动器本体66向近侧移动时，第一分度指状物264A和第二分度指状物264B偏转以允许侧壁226A、226B的一部分通过，直到邻近的缺口274与分度指状物264A、264B对准，从而允许分度指状物接合邻近的支撑表面276，例如，第二支撑表面276b。然后重复循环，以逐步方式向远侧推进导管组件。
有利地，包括限定反向通道的致动器本体66的实施方案需要相对较少的活动部件以便于制造和组装。进一步地，致动器本体66提供了通道，导管组件可以在该通道内行进。装置10还提供了在致动器组件20与安全组件46之间的双接触点，其围绕中心轴线被均匀地布置。这些特征提供均匀的施力，并且防止导管组件或其部分在远侧推进期间相对于纵向轴线枢转。这防止分度机构卡住，并且提供了更稳健的操作。
在实施方案中，导管插入装置10可以包括锁定装置。如本文更详细描述的，锁定装置可以包括按钮、套环、滑动件或接片中的一种。总体上，锁定装置可以选择性地限制分步推进机构以抑制导管插入装置10推进超过初始阶段，同时仍允许导管14相对于针18的一些运动。这允许使用者在部署导管14前破坏在导管14与针18之间的在制造过程中可能发生的任何粘附。然后，使用者可以选择性地解锁锁定装置，以允许导管插入装置10循环通过第一阶段。破坏粘附确保通过逐步推进的每个阶段的平滑的、均匀的推进。
如图7A至7B所示，在实施方案中，导管插入装置10包括锁定按钮240，该锁定按钮240包括与接合臂244联接的致动器表面242，并且可以在锁定位置(例如，图7A)与解锁位置之间转变。接合表面244包括限定第一直径(x)的第一大致圆形孔口246和限定第二直径(y)的第二大致圆形孔口248。如图7B所示，第一孔口246和第二孔口248可以连通以限定“锁孔”形孔口。如图7A所示，安全组件本体47包括圆柱形锚定部分250，其向近侧延伸并且限定大致圆形的截面。锚定件250的截面限定与第一孔口246的直径(x)相同或更小的直径。锚定件250还包括从锚定部分250的近端径向延伸的凸缘252。凸缘252限定大于第一孔口246的直径(x)但小于第二孔口248的直径(y)的直径。
如图7A所示，锁定按钮240被部署在锁定位置，在锁定位置中，锚定件250被布置在第一孔口246内，并且凸缘252抵靠接合臂244。在此位置中，安全组件46以及导管14和导管衬套16的纵向运动受到限制。
在实施方案中，安全组件46的纵向运动的距离被限制为小于邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离。在实施方案中，安全组件46的纵向运动的距离被限制为邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离的大致一半。在实施方案中，安全组件46的纵向运动被限制为1mm至3mm之间的纵向距离，然而也可以设想更大或更小的距离。
在锁定按钮240处于锁定位置的情况下，使用者能够移动致动器组件20，以便相对于针18移动导管14，但是不能够移动导管组件20超过逐步推进的第一步，即，不远至下一个接片60或支撑部260。这种运动破坏了在制造、组装、运输或储存期间可能已经形成的在导管14与针18之间的任何粘附。当使用者准备好推进导管时，锁定按钮240可以被转变至解锁位置，在解锁位置中，锚定件250被布置在第二孔口248内，并且凸缘252可以穿过孔口248。这允许致动器组件20以逐步方式推进导管组件，如在此所描述的。将理解的是，在不脱离本发明的精神的情况下，锁定按钮240和孔口246、248的配置和位置可以与图7A至7B所示的配置和位置不同。例如，孔口246、248的取向可以颠倒，使得锁定按钮240的解锁位置是延伸位置，并且锁定位置是缩回位置。类似地，按钮240的位置可以从壳体12的下表面、上表面或侧表面延伸。
有利地，锁定按钮240允许使用者破坏在组装、运输或储存期间可能已经形成的在导管14与针18之间的任何粘附。这在使用前松弛了导管14与针18之间的运动，并且在部署导管14时确保了平滑的、均匀的和受控的动作。
如图8A至8D所示，在实施方案中，导管插入装置10包括锁定套环280，其限制致动器按钮68、致动器组件和与其接合的导管组件的运动。锁定套环280被布置在壳体12的外表面上并且围绕纵向轴线环绕壳体12。在实施方案中，套环280环绕壳体12的一部分，使得可以通过垂直于纵向轴线滑动套环280而使套环与导管插入装置10分离。壳体12包括从其外表面延伸的一个或多个突出部，例如，第一突出部282和第二突出部284。锁定套环280可以相对于第一突出部282和第二突出部284滑动以在锁定位置与解锁位置之间转变。
如图8A至8B所示，锁定套环280可以被布置在锁定位置，在锁定位置中，套环280被布置在第一突出部282与致动器按钮68之间，以便覆盖开口32的至少一部分。在锁定位置中，致动器组件20和与其接合的导管组件的纵向运动受到限制。
在实施方案中，致动器组件20的纵向运动被限制为小于开口32的长度的距离。在实施方案中，致动器组件20的纵向运动被限制为开口32的长度的大致一半的距离。在实施方案中，致动器组件20的纵向运动的距离被限制为小于邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离。在实施方案中，致动器组件20的纵向运动的距离被限制为邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离的大致一半。在实施方案中，致动器组件20的纵向运动被限制为大约1mm至大约3mm之间的距离，然而也可以设想更大或更小的距离。
在锁定套环280处于锁定位置的情况下，使用者能够移动致动器组件20，以便相对于针18移动导管14，但是不能够移动导管组件超过逐步推进的第一步，即，不远至下一个壳体接片60或壳体支撑部260。这种运动破坏了在组装、运输或储存期间可能已经形成的在导管14与针18之间的任何粘附。当使用者准备好推进导管14时，锁定套环280可以被移除或被滑动至解锁位置，即，在第一突出部282与第二突出部284之间，在此处套环280不覆盖开口32。这允许致动器组件20以逐步方式推进导管组件，如在此所描述的。
在实施方案中，第一突出部282被布置在开口32的远端或近端中的一个处，并且被配置为限制套环280相对于壳体的沿着纵向轴线的运动，以将锁定套环280维持在锁定位置。当准备使用时，使用者可以使锁定套环280在第一突出部282上滑动至“解锁”位置。在实施方案中，套环280进一步包括在套环280的内表面上的滑件286，以便于在第一突出部282上移动锁定套环280。
第二突出部284可以被定位成与第一突出部282相距一定距离，使得锁定套环280可以被接收在其之间。在实施方案中，第一突出部282和第二突出部284从壳体12的外表面突出类似的高度。可选地，锁定套环280可以被滑过第二突出部284并且被从导管插入装置10移除。在实施方案中，与第一突出部282相比，第二突出部284从壳体12的外表面突出得更远，并且防止锁定套环280从导管插入装置10移除。可选地，锁定套环280包括对比颜色、触觉特征、抓握特征、字母数字符号、图标或其组合，以将锁定套环280与壳体12的锁定套环区分开，并且通知使用者导管插入装置10处于锁定位置还是解锁位置。
如图8A至8D所示，锁定套环280、第一突出部282和第二突出部284被布置在致动器按钮68与导管插入装置10的近端之间，使得套环280在近侧方向上被滑动至“解锁”位置。然而，将理解的是，在不脱离本发明的精神的情况下，可以以其他配置布置致动器按钮68、锁定套环280、第一突出部282和第二突出部284的取向。例如，套环280可以在远侧方向上被滑动以从锁定位置移动至解锁位置，并且可选地从导管插入装置10被移除。
如图9A至9C所示，在实施方案中，导管插入装置10可以包括锁定滑动件270，其可以在限制致动器按钮68的运动的锁定位置(图9A)与允许致动器组件沿着细长的开口32移动的解锁位置(图9C)之间转变。在实施方案中，锁定滑动件270可以垂直于纵向轴线(即，致动器组件20的行进方向)被滑动以接合缺口268。然而，将理解的是，也可以设想滑动件270和缺口268的其他取向。
滑动件270的纵向宽度可以限定第一宽度(a)。缺口268的纵向宽度可以限定第二宽度(b)。在实施方案中，滑动件的宽度(a)小于缺口的宽度(b)。缺口268可以接合滑动件270以限制致动器组件20的运动。如图9A所示，锁定滑动件270被部署在锁定位置，在锁定位置中，滑动件270接合缺口268。在此位置中，安全致动器组件20和与其接合的导管组件的纵向运动受到限制。
在实施方案中，致动器组件20的纵向运动被限制为小于开口32的长度的距离。在实施方案中，致动器组件20的纵向运动被限制为开口32的长度的大致一半的距离。在实施方案中，致动器组件20的纵向运动的距离被限制为小于邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离。在实施方案中，致动器组件20的纵向运动的距离被限制为邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离的大致一半。在实施方案中，致动器组件20的纵向运动被限制为大约1mm至大约3mm之间的距离，然而也可以设想更大或更小的距离。
在锁定滑动件270处于锁定位置的情况下，使用者能够移动致动器组件20，以便相对于针18移动导管14，但是不能够移动导管组件超过逐步推进的第一步，即，不远至下一个壳体接片60或壳体支撑部260。这种运动破坏了在组装、运输或储存期间可能已经形成的导管14与针18之间的任何粘附。当使用者准备好推进导管时，锁定滑动件270可以被移动至解锁位置，在解锁位置中，致动器组件20可以以逐步方式推进导管组件，如本文描述的。
图10A至10D示出了包括锁定接片290的导管插入装置10的实施方案。图10A示出了导管插入装置10的平面视图，并且图10B示出了导管插入装置10的剖面侧视图，其中锁定接片290处于“锁定”位置中，即，被布置在壳体12的引导狭槽77内。应当注意，致动器本体66的近端74包括引导销75，其被容纳在狭槽77内以使致动器本体66的近端74稳定。其进一步的细节可以在WO 2018/170349中找到，该申请通过引用以其全文结合在此。
图10C示出了导管插入装置10的剖面平面视图，并且图10D示出了导管插入装置10的剖面侧视图，其中锁定接片290处于“解锁”位置，即，从狭槽77移除。在实施方案中，导管插入装置10包括布置在壳体12的第一侧上的第一狭槽77A和布置在壳体12的与第一侧相对的第二侧上的第二狭槽77B。在实施方案中，锁定接片290可以被布置通过第一狭槽77A或第二狭槽77B中的任何一个。在实施方案中，锁定接片290可以被布置通过第一狭槽77A和第二狭槽77B两者。
如图10B所示，在“锁定”位置中，锁定接片290被布置在致动器组件20的近端与壳体12的内表面之间，即，在引导销75与狭槽77的近侧边缘之间，以限制致动器组件20和导管14的运动。锁定接片290的纵向宽度(t)可以小于狭槽77A、77B的纵向长度，并且可以被修改以改变施加在致动器组件20上的限制量。
在实施方案中，致动器组件20的纵向运动被限制为小于第一狭槽77A或第二狭槽77B的纵向长度。在实施方案中，致动器组件20的纵向运动被限制为第一狭槽77A或第二狭槽77B的纵向长度的大致一半的距离。在实施方案中，致动器组件20的纵向运动的距离被限制为小于邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离。在实施方案中，致动器组件20的纵向运动的距离被限制为邻近的壳体支撑部260、邻近的致动器支撑部276、邻近的壳体接片60或邻近的致动器接片76之间的纵向距离的大致一半。在实施方案中，致动器组件20的纵向运动被限制为大约1mm至大约3mm之间的距离，然而也可以设想更大或更小的距离。
在锁定按钮240处于锁定位置的情况下，使用者能够移动致动器组件20，以便相对于针18移动导管14，但是不能够移动导管组件超过逐步推进的第一步，即，不远至下一个接片60或支撑部260。这种运动破坏了在制造、组装、运输或储存期间可能已经形成的在导管14与针18之间的任何粘附。在使用者准备好推进导管时，可以移除锁定接片290。这允许致动器组件20以逐步方式推进导管组件，如在此所描述的。可选地，锁定装置(例如，锁定接片290)可以包括对比颜色、触觉特征、抓握特征、字母数字符号、图标或其组合，以将锁定接片290与壳体12的锁定接片区分开，并且通知使用者导管插入装置10处于锁定位置还是解锁位置。
虽然本文已经公开了一些具体实施方案，并且虽然已经详细地公开了这些具体实施方案，但是这些具体实施方案的意图并非限制本文提供的概念的范围。另外的适配和/或修改对于本领域普通技术人员而言可以是明显的，并且在更广泛的方面，这些适配和/或修改也被涵盖。因此，在不脱离本文提供的概念的范围的情况下，可以对本文公开的具体实施方案做出改变。

Claims (32)

1.一种导管放置装置，包括：
壳体；
针，其从所述壳体的远端延伸；
导管组件，其同轴地布置在所述针上，包括导管和安全组件，所述导管由导管衬套支撑，所述安全组件包括第一分度指状物；和
致动器组件，其配置为在第一位置与第二位置之间纵向地转变，所述致动器组件包括：
致动器按钮，其延伸通过在所述壳体中的细长的开口；和
致动器本体，其包括多个致动器支撑部，其中所述第一分度指状物接合所述多个致动器支撑部中的第一致动器支撑部，并且随着所述致动器组件在所述第一位置与所述第二位置之间移动，所述致动器组件以逐步方式向远侧推进所述导管组件。
2.根据权利要求1所述的导管放置装置，其中所述第一分度指状物与所述安全组件整体模制以形成单个结构，所述第一分度指状物配置为伴随所述致动器本体从所述第二位置移动至所述第一位置而柔性地变形。
3.根据权利要求1所述的导管放置装置，其中所述第一分度指状物由套环支撑并且形成为与所述安全组件分开的结构，所述套环被联接至所述安全组件，并且所述第一分度指状物配置为伴随所述致动器本体从所述第二位置移动至所述第一位置而柔性地变形。
4.根据权利要求1所述的导管放置装置，其中所述壳体包括多个壳体接片，所述多个壳体接片接合所述安全组件以防止所述安全组件的近侧运动。
5.根据权利要求1所述的导管放置装置，其中所述壳体包括多个壳体支撑部，所述多个壳体支撑部接合从所述安全组件延伸的第二分度指状物，以防止所述第二分度指状物的近侧运动。
6.根据权利要求1所述的导管放置装置，其中所述致动器本体包括限定反向通道的顶壁、第一侧壁和第二侧壁，所述导管组件沿着纵向轴线通过所述反向通道移动。
7.根据权利要求6所述的导管放置装置，其中所述第一侧壁或所述第二侧壁中的一个包括多个缺口，所述多个缺口限定所述多个致动器支撑部。
8.根据权利要求6所述的导管放置装置，其中所述第一侧壁或所述第二侧壁中的一个包括多个孔口，所述多个孔口限定所述多个致动器支撑部。
9.根据权利要求1所述的导管放置装置，其中所述壳体包括第一门和第二门，所述第一门和所述第二门布置在所述壳体的远端处并且配置为在打开位置与关闭位置之间通过水平平面枢转。
10.根据权利要求9所述的导管放置装置，其中所述壳体包括沿着纵向竖直平面结合的第一壳体半部和第二壳体半部，所述第一门铰接地联接至所述第一壳体半部，并且所述第二门铰接地联接至所述第二壳体半部。
11.根据权利要求1所述的导管放置装置，其中所述壳体包括第一铰接门，所述第一铰接门布置在所述壳体的远端处并且配置为通过竖直平面枢转。
12.根据权利要求11所述的导管放置装置，其中所述壳体包括沿着纵向水平平面结合的第一壳体半部和第二壳体半部，所述第一门铰接地联接至所述第一壳体半部。
13.根据权利要求1所述的导管放置装置，进一步包括锁定装置，所述锁定装置在锁定位置与解锁位置之间转变，所述锁定位置允许所述导管相对于所述针的运动并且限制所述导管组件以逐步方式的远侧推进。
14.根据权利要求13所述的导管放置装置，其中所述导管相对于所述针的运动被限制为小于在所述第一致动器支撑部与邻近所述第一致动器支撑部的第二致动器支撑部之间的纵向距离。
15.根据权利要求13所述的导管放置装置，其中所述导管相对于所述针的运动被限制为小于在所述第一致动器支撑部与邻近所述第一致动器支撑部的第二致动器支撑部之间的纵向距离的一半。
16.根据权利要求13所述的导管放置装置，其中所述导管相对于所述针的运动被限制为1mm至3mm之间的距离。
17.根据权利要求13所述的导管放置装置，其中所述锁定装置包括锁定按钮，所述锁定按钮包括接合臂，所述接合臂具有限定第一直径的第一孔口和限定第二直径的第二孔口，所述第二直径大于所述第一直径，所述第一孔口与所述第二孔口连通以限定锁孔形状，所述锁孔形状接收由其通过的所述安全组件的锚定部分。
18.根据权利要求17所述的导管放置装置，其中所述锁定按钮在所述锁定位置和解锁位置之间转变，所述锚定部分在所述锁定位置中被布置在所述第一孔口内并且在所述解锁位置中被布置在所述第二孔口内。
19.根据权利要求18所述的导管放置装置，其中所述锚定部分包括从所述锚定部分的近端径向延伸的凸缘，所述凸缘限定大于所述第一直径且小于所述第二直径的直径，当所述锁定按钮处于所述锁定位置时，所述凸缘抵靠所述接合臂。
20.根据权利要求13所述的导管放置装置，其中所述锁定装置包括锁定套环，所述锁定套环与所述壳体的外表面可滑动地接合并且在所述锁定位置与所述解锁位置之间纵向地转变。
21.根据权利要求20所述的导管放置装置，其中所述锁定套环环绕所述壳体的纵向轴线，所述锁定套环在所述锁定位置中覆盖所述细长的开口的一部分，以限制所述致动器组件的运动。
22.根据权利要求20所述的导管放置装置，其中所述锁定套环在所述锁定位置中被布置在所述致动器按钮与第一突出部之间，并且在所述解锁位置中被布置在所述第一突出部与第二突出部之间。
23.根据权利要求13所述的导管放置装置，其中所述锁定装置包括锁定滑动件，所述锁定滑动件布置在所述致动器按钮上，并且当处于所述锁定位置时，垂直于纵向轴线滑动以接合缺口。
24.根据权利要求23所述的导管放置装置，其中所述滑动件的纵向宽度小于所述缺口的纵向宽度，以允许所述致动器按钮在所述锁定位置中的运动并且限制所述导管组件以逐步方式的远侧推进。
25.根据权利要求23所述的导管放置装置，其中处于所述解锁位置的所述锁定滑动件与所述致动器按钮对准以脱离所述缺口，并且允许所述致动器组件在所述第一位置与所述第二位置之间移动。
26.根据权利要求13所述的导管放置装置，其中所述锁定装置包括锁定接片，所述锁定接片在所述锁定位置中置于所述致动器组件与所述壳体之间，从而限制所述致动器组件的运动。
27.根据权利要求23所述的导管放置装置，其中所述锁定接片延伸通过在所述壳体中的狭槽，所述接片限定小于所述狭槽的纵向长度的纵向宽度。
28.一种插入导管的方法，包括：
提供导管插入装置，所述导管插入装置包括：
壳体；
针，其从所述壳体的远端延伸；
致动器组件，其包括致动器按钮和致动器本体；
导管组件，其同轴地布置在所述针上，所述导管组件包括：
由导管衬套支撑的导管；和
安全组件；和
锁定装置，其在锁定位置与解锁位置之间可转变，所述锁定位置准许所述导管相对于所述针的运动并且抑制所述导管以逐步方式的推进；
在所述锁定装置处于所述锁定位置的情况下，致动所述致动器按钮，以相对于所述针移动所述导管；
将所述锁定装置从所述锁定位置转变至所述解锁位置；
将所述针插入患者以进入其脉管系统；并且
将所述致动器按钮从第一位置致动至第二位置，以相对于所述针以逐步方式推进所述导管。
29.根据权利要求28所述的方法，其中所述致动器本体包括多个致动器支撑部，并且所述安全组件包括分度指状物，随着所述致动器按钮从所述第一位置移动至所述第二位置，所述分度指状物接合所述多个致动器支撑部中的一个致动器支撑部，并且随着所述致动器按钮从所述第二位置移动至所述第一位置，所述分度指状物偏转。
30.一种在针上推进导管的方法，包括：
提供导管放置装置，所述导管放置装置包括：
壳体，其包括多个壳体接片和从所述壳体的远端延伸的针；
导管组件，其包括导管，所述导管同轴地布置在所述针上并且接合所述多个壳体接片中的第一壳体接片；
致动器组件，其配置为在第一位置与第二位置之间移动，以将所述导管组件从所述第一壳体接片推进至邻近所述第一壳体接片的第二壳体接片；和
锁定装置，其在锁定位置与解锁位置之间可转变，所述锁定位置限制所述导管组件在所述第一壳体接片与所述第二壳体接片之间的运动，所述解锁位置准许所述导管组件在所述第一壳体接片与所述第二壳体接片之间的运动；
在所述锁定装置处于所述锁定位置的情况下，致动所述致动器按钮，以相对于所述针移动所述导管，同时防止所述导管组件从所述第一壳体接片推进至所述第二壳体接片；
将所述锁定装置从所述锁定位置转变至所述解锁位置；
将所述针插入患者以进入其脉管系统；并且
将所述致动器按钮从所述第一位置致动至所述第二位置，以将所述导管组件从所述第一壳体接片推进至所述第二壳体接片。
31.根据权利要求30所述的方法，其中所述锁定装置是锁定按钮、锁定套环、锁定滑动件和锁定接片中的一个。
32.根据权利要求30所述的方法，其中所述壳体包括第一铰接门和第二铰接门，所述第一铰接门和所述第二铰接门中的每个布置在所述壳体的所述远端处并且配置为枢转至打开位置以释放所述导管衬套。
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US20210052858A1 (en) 2021-02-25
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