CN100506310C - 用于插入输液设备插管的设备和方法 - Google Patents

用于插入输液设备插管的设备和方法 Download PDF

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CN100506310C
CN100506310C CNB2004800328928A CN200480032892A CN100506310C CN 100506310 C CN100506310 C CN 100506310C CN B2004800328928 A CNB2004800328928 A CN B2004800328928A CN 200480032892 A CN200480032892 A CN 200480032892A CN 100506310 C CN100506310 C CN 100506310C
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equipment
shell
syringe needle
needle hub
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CN1878591A (zh
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马克·亨利·福斯特
詹姆斯·马尔斯
史蒂夫·科特
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Smiths Medical ASD 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
    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14503—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • 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
    • A61M2005/1581—Right-angle needle-type devices
    • 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
    • A61M2005/1583—Needle extractors
    • 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
    • A61M5/178—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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Abstract

一种用于将皮下输液设备的插管插入到患者皮肤的皮下层内的设备。例如，某些设备自动地缩回一个针头，其中所述针头是用来将皮下输液设备的插管导入到患者皮肤的皮下层内的。所述设备可包括一个具有一个内腔的外壳、以及一个耦合到该外壳的针头。所述针头可耦合到一个皮下输液设备的插管。一个构件可以移动该针头。一旦针头以及相关联的皮下输液设备的插管完全导入患者皮肤的皮下层内，该构件就自动地致动而将针头移入所述外壳的内腔中，使所述针头进入缩回状态，而将所述皮下输液设备的插管留在患者皮肤的皮下层内。

Description

用于插入输液设备插管的设备和方法
技术领域
本发明涉及一种设备，其用于帮助将输液设备的插管导入到患者的皮肤内，从而将物质输入患者体内。
背景技术
输液设备用来将例如药物等物质输入至患者皮肤的皮下层。用于帮助将输液设备的插管插入到患者皮肤内的设备是公知的。例如，某些设备使用弹簧将针头自动地驱入患者的皮肤内，从而将输液设备的插管导入到皮下层中。
因为使用针头来将输液设备的插管导入到皮肤的皮下层中，所以存在由于无意中与针头接触而带来的危险。此外，在插入之前，在看到针头时，患者的反应可能是负面的，例如，不愿意把针头置入皮肤内。在输液设备的导入之前和/或之后，现有技术的设备可能没有把这个针头充分地遮蔽起来。
与插入设备的设计和使用相关的其它问题为：患者容易使用以及卫生。例如，有些患者可能在将输液设备装入到插入设备中方面具有困难。
从而，希望为所述设备提供新的设计，用于帮助将输液设备导入患者的皮肤中。
发明内容
依据本发明而作出的实施方式包括可用于帮助将输液设备的插管导入到患者皮肤内而将物质输送到患者体内的设备。
例如，一种设备的实施方式包括一个针头，该针头用于将输液设备的插管插入到患者的皮肤内。一旦输液设备的插管插入到皮肤内，设备将针头移动到一个处于设备内部的缩回位置上。
在另一个实施方式中，一个设备构造成：将输液设备的针头以及相关插管从送入状态(delivery state)移入触发状态(trigger state)，在触发状态中，输液设备的插管插入患者的皮肤内。一旦插管在触发状态下完全地插入，则设备构造成然后将针头移动到一个处于设备内部的缩回位置上。
在另一个实施方式中，一个设备包括一个针头，所述针头用于将定位帖片(site)的插管插入到患者的皮肤内。一旦插管插入，针头可从皮肤上移去。在一种实施方式中，设置有一个盖体，其可在设备使用之前和之后放置在设置上，以提供一个卫生的环境和/或减少与针头的接触。
本发明上述的概括并不意图用来描述本发明的每个公开的实施方式或每个示例。下文详细描述中的附图更为具体地解释了本发明的实施方式。虽然示出及描述了某些实施方式，但是本发明并不限于在这些实施方式中使用。
附图说明
图1为一个依据本发明制作的设备的示例实施方式的侧视图，其用于将注射设备的插管导入到患者体内。
图2为图1设备的分解侧视图。
图3为图1设备外壳的立体图。
图4为图3的外壳的侧视图。
图5为图3的外壳的端视图。
图6为图1设备圆筒形套筒(cylinder hub)的立体图。
图7为图6中圆筒形套筒的侧视图。
图8为图6中圆筒形套筒的另一侧视图。
图9为图6中圆筒形套筒的端视图。
图10为图1设备的针头套筒的立体图。
图11为图10的针头套筒的侧视图。
图12为图10的针头套筒的另一侧视图。
图13为图10的针头套筒的端视图。
图14为图1中设备的套管的立体图。
图15为图14中套管的侧视图。
图16为图14中套管的另一侧视图。
图17为图14中套管的端视图。
图18为图1中设备的一个粘合部分的俯视图。
图19为沿图18中粘合部分的19-19线的剖视图。
图20为图18中粘合部分的分解视图。
图21为图1中设备的盖体的立体图。
图22为图21中盖体的侧视图。
图23为图21中盖体的端视图。
图24为图1中设备的侧视图，且移除了盖体。
图25为图24中设备在触发状态时的侧视图。
图26A为图1中设备处于装运状态(ship state)时沿26A-26A线的剖视图。
图26B为图1中设备处于装运状态时沿26B-26B线的剖视图。
图27A为图24中设备处于送入状态时沿27A-27A线的剖视图。
图27B为图24中设备处于送入状态时沿27B-27B线的剖视图。
图28A为图25中设备处于触发状态时沿28A-28A线的剖视图。
图28B为图25中设备处于触发状态时沿28B-28B线的剖视图。
图28C为图28B中设备的剖视图，其示出粘合部分从套管的表面上剥离。
图29A为图28A中设备的剖视图，其中针头套筒缩回。
图29B为图28B中设备的剖视图，其中针头套筒缩回。
图30A为图24中设备处于缩回状态时沿30A-30A线的剖视图。
图30B为图24中设备处于缩回状态时沿30B-30B线的剖视图。
图31为另一个依据本发明制作的设备的示例实施方式的一部分的剖视图，该设备用于将注射设备导入到患者体内。
图32A为另一个依据本发明制作的、处于装运状态的设备的示例实施方式的剖视图，该设备用于将注射设备导入到患者体内。
图32B为沿图32A中设备正交面的剖视图。
图33A为图32A中设备处于送入状态的剖视图。
图33B为图32B中设备处于送入状态的剖视图。
图34A为图32A中设备处于缩回状态的剖视图。
图34B为图32B中设备处于缩回状态的剖视图。
图35为图32A中设备的套筒的立体图。
图36为图35中套筒的侧视图。
图37为图35中套筒的另一侧视图。
图38为图35中套筒的端视图。
图39为另一个依据本发明制作的设备的示例实施方式的立体图，该设备用于将注射设备导入到患者体内。
图40为图39中设备的另一个立体图。
图41为图39中设备的侧视图。
图42为图39中设备的端视图。
图43为图39中设备的相对端视图。
图44为依据本发明制作的设备的另一示例实施方式的立体图，该设备用于将注射设备导入到患者体内。
图45为图44中设备的侧视图。
图46为图44中设备的另一侧视图。
图47为图44中设备的端视图。
图48为图44中设备的另一端视图。
图49为沿图45中设备49-49线的剖视图。
图50为依据本发明制作的设备的另一示例实施方式的侧视图，该设备用于将注射设备的插管导入到患者体内，并包括一个显窃启密封(tamper-evident seal)。
图51为图50中设备的侧视图，其中盖件被分开，且显窃启密封断掉。
图52为图50中设备的一个部分沿52-52线的剖视图。
具体实施方式
本发明的实施方式涉及一种设备，该设备用于帮助将输液设备——特别是输液设备的插管——导入到患者皮肤的皮下层内。
参照图1和2，其示出了设备100的一个示例实施方式。设备100用于将一个输液设备——例如套(set)、定位贴片、或者其它的接入装置——的插管导入到患者皮肤内。所述的套、定位贴片、或者其它的接入装置然后可用于将药物或其它流体而输入到患者体内，例如从一个输液泵。
设备100大致包括一个外壳110、一个圆筒形的套筒120、一个针头套筒130、一个套管140、一个弹簧150、一个粘合部分160、以及一个盖体170。设备100的每个部件在下文进一步描述且构造成：帮助将输液设备的插管导入到患者的皮肤内。
现在参照图3-5，其示出了外壳110。外壳110的形状优选地是圆筒形的，并包括一个封闭的上端111以及一个开口的下端112。外壳110进一步优选地包括一个具有滚花表面的部分118，以利于患者握持外壳110，还包括一个邻近开口下端112设置的螺纹部分113。
现在参照图6-9，其非常详细地示出了圆筒形的套筒120。圆筒形的套筒120包括第一端221、第二端222以及一个内部通道223。此外，两个背对的槽缝225形成在圆筒形套筒120的相对侧上，并大致上从圆筒120的中部224延伸到第一端221。此外，圆筒形套筒120包括背对的孔口226，所述孔口226邻近于第二端222而形成于圆筒形套筒120中。
圆筒形套筒120的第一端221通过外壳110上的薄片119耦合到外壳110的上端111，所述薄片119与由圆筒形套筒120形成的肩部228相接合。例如，参看视图6-8、26A、以及26B。此外，外壳110的构件121容置在圆筒形套筒120的槽缝229中。在可选的设计中，外壳110以及圆筒形套筒120可形成为单个单元。
现在参照图10-13，针头套筒130包括一个具有第一和第二端332、333的主体331，且一个针头336(中空的或实心的)耦合到主体331。主体331包括背对的、形成于第一端332处的背对的翼状件334以及形成于第二端333处的背对的倒钩335。
针头套筒130设置在圆筒形套筒120的内部通道223内，使得针头套筒130的背对翼状件334延伸通过圆筒形套筒120的背对槽缝225。参考视图6、8、26B、27B、28B、29B以及30B。此外，针头套筒130的背对倒钩335延伸通过圆筒形套筒120的背对孔口226，并与由孔口226形成的肩部227接合，使得针头套筒130相对于圆筒形套筒120以及外壳110保持在一个固定的位置上。例如，参看视图6、8、26A、27A以及28A。
现在参照图14-17，其示出了套管140。套管140的形状优选地是圆筒形的，并包括第一端441和第二端442以及内部通道443。相对的突起444在邻近肩部445处延伸入通道443内。在套管140的外部形成有槽道446，同时，带有倒钩448的轨道447形成于套管140的端部上。
套管140耦合到外壳110，使得外壳110可以相对于套管140纵向地移动。特别地，外壳的轨道114容置在套管140的槽道446中。类似地，套管140的轨道447容置在外壳110的槽道115中。套管140轨道447上的倒钩448与外壳110槽道115中的突起116接合，使得外壳110抵抗由弹簧150(在下文进一步描述)所施加的力而保持与套管140可滑动地耦合。
弹簧150包括第一端152和第二端154。参看例如视图26B。弹簧150包绕圆筒形套筒120的一部分且在套管140的通道443内延伸。弹簧150的第一端152位于套管140的肩部445上，而弹簧150的第二端154接合所示针头套筒130的背对翼状件334，所述翼状件334延伸通过圆筒形套筒120的背对槽缝225。
弹簧150处于一个被压缩的状态，如图26A、26B、27A、27B、28A以及28B所示，从而对针头套筒130的翼状件334施加一个推力，朝上地偏压针头套筒130。然而，针头套筒130主体331的倒钩335接合抵靠在圆筒形套筒120的孔口226肩部227上，从而相对于圆筒形套筒120将针头套筒130保持在适当的位置上。例如，参看视图26A。类似地，弹簧150迫使外壳110和套管140分开，直至套管140的倒钩448接合外壳110的突起115，从而维持外壳110和套管140之间的耦合。
现在参照图18-20，一个粘合部分160设置在套管140的第二端442处的表面449上(参见图14和17)。表面449优选地起到一个支架的作用，其在放置到患者身体上之前稳定住粘合部分160。在所示的一个优选实施方式中，粘合部分160包括层662、663和664、以及衬垫661和665。衬垫661和665还优选地包括薄片666和667，所述薄片可用于除去衬垫661和665，如下文所述。
粘合部分160可通过不同的方式耦合到套管140的表面449。在一个优选的实施方式中，衬垫661被除去了，而层662通过粘合剂而耦合到表面449。此外，如下文所进一步描述的，在一个优选的实施方式中，层664的顶面669和/或输液设备的下端包含粘合物，以在输液设备移动至与粘合部分接触时将输液设备耦合到粘合部分160。参看视图28A、28B以及28C。
此外，优选地去掉衬垫665，并且层664的下表面668包含粘合物，以将粘合部分160耦合到患者的皮肤。
优选地，在将粘合部分160施加到设备100上之前，定位贴片装到设备100中，并且优选地，衬垫661和665都在将粘合部分附接到套管140上以及将盖体170耦合到外壳110之前如上所述地移去。以此方式，患者优选地不需要在将粘合部分160施加到皮肤上以及将定位贴片设在到皮肤上之前移除任何衬垫。
优选地，层664不包括任何孔，而是在针头336朝皮肤移动时由针头336刺穿，如下文所进一步描述的。这种构造可增加粘合部分160以及患者皮肤之间的配合。
在一个优选的实施方式中，粘合部分160包括位于一个或多个表面668和669上的粘合剂，以允许粘合部分160耦合到套管140、定位贴片、和/或患者的皮肤。可用在粘合部分160上的典型粘合剂包括但不限于丙烯酸粘合剂、以合成橡胶为基础的粘合剂、丙烯酸脂粘合剂、以及硅酮基粘合剂。
在示例实施方式中，粘合部分160包括其上带有粘合剂的膜，例如由3MTM制造的TegadermTM膜或由Smith & Nephew制造的IV3000TM膜。例如，在所示的优选实施方式中，胶带层662是3MTM 9731胶带，而层663和664为3MTM TegadermTM p/n9842。
现在参照图21-23，其示出了盖体170。盖体170包括一个封闭的第一端772以及一个开口的第二端774。盖体170优选地包括一个带有滚花表面778的外部，以利于患者对盖体170的握持。此外，盖体170的内部包括一个邻近开口端774设置的螺纹部分776，使得螺纹部分776可拧到外壳110的螺纹部分113上，从而密封设备100。参见视图1、26A、以及26B。
在一个优选实施方式中，一个垫圈122设置在外壳110的螺纹部分113上，以在盖体170拧到外壳110上时在盖体170和外壳110之间形成密封。参见视图26A以及26B。以此方式，在移去盖体170之前，设备100的内部部件(例如针头336和定位贴片800)可保持在一个基本上卫生的状态中。此外，在从外壳110上移去盖体170之前，盖体170可起作用以将设备100保持在一个装运状态中(即，外壳110不能相对于套管140移动)。
在可选实施方式中，盖体170和/或外壳110可形成为提供一个显窃启密封，从而，患者可以判断盖体170是否与外壳110分开过。例如，在图50-52中所示设备100’的可选实施方式中，示出了一个显窃启带178。带178包括耦合到盖体170上的薄片179，如图50所示。当盖体170从外壳110上移去时(即，盖体170上的螺纹514从外壳110上的螺纹512拧开)，薄片179从盖体170脱开，而密封178继续耦合到外壳110上，如图51所示。如果盖体170是后来拧回到设备100’上的，那么薄片179与盖体170之间的脱离是明显的，使得患者可以判断设备100’的盖体170以前已经被移动过。
盖体170和带178可在制造过程中作为单个单元设置在设备100’上。例如，如图52所示，盖体170和带178可被压在设备100’上(注意：螺纹512和514可以是倒圆角的以允许盖体170被压到设备100’上)，使得带178的部分520经过外壳110的肩部522并与之接合，以在盖体170拧开且薄片179断开时将带178保持在外壳110上。此外，在盖体170和带178被压到设备100’上时，沿带178周期性地形成的缺口(notch)524防止盖体170降到最低点抵靠带178，从而带179保持未被动过。还可以形成一个沿盖体170的内周延伸的部分502，以接合外壳110的外表面，从而在外壳110和盖体170之间形成一个密封。
有利地，可设置一个显窃启密封，使得例如患者可以确信设备100’先前没有被打开过并且在使用前是卫生的。也可以使用其它指示窃启的方法。
如先前所注意到的，设备100可用于将输液设备的插管导入到患者皮肤的皮下层内。在一个优选的实施方式中，输液设备包括一个定位贴片800，所述定位贴片800包括一个用于将物质输送入患者皮肤的皮下层的插管。定位贴片800通过管路(未示)联结到一个流源——例如一个输液泵(未示)——而将流体通过插管输送到患者体内。在一个优选的实施方式中，定位贴片800可依据美国专利申请10/705,736中所公开的内容而制作，在此将该美国专利申请的全文引入本文中作为参考。然而，也可以使用其它构造的定位贴片。
现在参照图1以及24-30，设备100示出为处于不同的使用状态下。如图1、26A、和26B所示，设备100处于使用前的装运状态。如图24、27A、和27B所示，设备100处于送入状态，已经准备好将输液设备的插管送入患者的皮肤。如图25、28A、28B、和28C所示，设备100处于触发状态，或者说一个这样的状态：其中针头336以及定位贴片800的插管被完全地插入到患者皮肤的皮下层内，且针头套筒130以及相联的针头336将要缩回。如图29A和29B所示，设备100处于缩回状态，其中针头套筒130以及相联的针头336已经缩回到设备100内。如图30A和30B所示，设备100处于一个完全缩回状态，其中外壳110以及套管140相对于彼此回复到未压缩的位置。
下文是设备100的一个示例的使用方法。为患者提供设备100，其中盖体170耦合到外壳110，如图1、26A、和26B所示。优选地，定位贴片800已经例如在设备100的制造过程中被预先装(即预载)到设备100中。
然后，盖体170从外壳110拧下，且设备100的套管140定位成使得粘合部分160(即表面668)接触患者的皮肤900。参见视图24、27A、和27B。
然后，在所示的实施方式中，患者对外壳110的上端111施加压力，以相对于套管140、并朝向患者的皮肤900沿方向A移动外壳110以及相关的结构——包括圆筒形套筒120以及针头套筒130(包括针头226和定位贴片800)。当针头套筒130的针头336以及相应的定位贴片800沿方向A移动时，针头336以及定位贴片800的插管806被导入到患者的皮肤900内。此外，随着针头套筒130朝套管140移动，弹簧150被进一步地压缩。
一旦针头336以及定位贴片800的插管806被完全地插入到皮肤900内，设备100处于触发状态，如图25、28A、28B、和28C所示。在此状态中，将针头套筒130耦合到圆筒形套筒120的倒钩335通过与套管140所形成的突起444接触而被向内地偏置。
随着外壳110、圆筒形套筒120、以及针头套筒130进一步地沿方向A移位，优选地，定位针头套筒130，使得定位贴片800的下部略微地移出套管140的第二端442之外，如图28C所示。这个“过度移动”确保粘合部分160正确地从套管140的表面449剥离，并使得定位贴片800可以耦合到粘合部分160。例如，在优选的实施方式中，定位贴片800的下部移出套管140的第二端442之外千分之50-100英寸，更优选地大约为千分之70英寸。
此外，随着外壳110、圆筒形套筒120、以及针头套筒130如上所述地进一步沿方向A移位，针头套筒130的倒钩335通过套管140的突起444而被压向内侧，从而，倒钩335脱离与圆筒形套筒120的接合。一旦针头套筒130的倒钩335从圆筒形套筒120中释放出来，针头套筒130可在圆筒形套筒120的通道223内沿与方向A相反的方向B自由地纵向移动。通过外壳110沿方向A的移动而已经压缩的弹簧150沿方向B推动针头套筒130以及相关的针头336，使之穿过圆筒形套筒120而抵达外壳110的上端111，同时留下定位贴片800以及其位于患者的皮肤900内的相关插管806，如图29A和29B所示。
一旦患者从外壳110的上端111撤去压力后，弹簧150导致外壳110以及圆筒形套筒120沿方向B移动到一个完全缩回状态，如图30A和30B所示。
最后，套管140脱离与皮肤900的接触，且盖体170可再次放置到设备100外壳110的螺纹部分113上。随后，设备100可以报废。
可提供许多可选设计用于所述设备。例如，在图31中，示出一个可选设备的一部分，其包括圆筒形套筒120’和针头套筒130’。圆筒形套筒120’和针头套筒130’与上述的圆筒形套筒120和针头套筒130类似，但是圆筒形套筒120’包括邻近圆筒形套筒120’第一端221而形成的突起129，而针头套筒130’包括形成于第一端332上的倒钩139。倒钩139构造成：在针头336沿方向B缩回时，所述倒钩139抵靠圆筒形套筒120’的内部通道223的内侧，直至倒钩139延伸出筒形套筒120’的突起129。一旦发生了此情形，则倒钩139略微地向外张开。在如图31所示的这个构造中，倒钩139防止针头套筒130’以及相关针头336沿方向A回移。由此，倒钩129将针头套筒130’锁定在缩回位置上。这个构造可以单独使用或与弹簧150的力——其沿方向B推动针头套筒130’——一起作用使用，以进一步有利地减少针头36在缩回后无意地露出的可能性。
依据另一个可选的实施方式，设备100”示出于图32-38中。设备100”与上述的设备100类似，其不同之处在于套管(例如套管140)由一个触发装置140’代替。在设备100”中，触发装置140’(视图35-38)的作用与用来在插入前遮蔽针头336的套管140不同，触发装置140’的作用是在完全插入时导致针头336缩回，参见下文的进一步描述。
在设备100”的这个实施方式中，一旦盖体170被移除掉，针头336就被露出来，如图33A和33B所示。在这个构造中，与相对于外壳纵向地移动外壳110、圆筒形套筒120、以及针头套筒130不同，患者通过握持外壳110以及将露出的针头336导入皮肤内而简单地把针头336以及定位贴片的相关插管806插入到皮肤内。
当针头336以及插管806实现完全插入时，触发装置140’接触皮肤，从而导致包括针头336的针头套筒130缩回到外壳110内，把定位贴片800留在皮肤上的适当位置。在所示的实施方式中，触发装置140’是自动的，因为触发装置140’构造成导致针头套筒130的倒钩335向内移位以从圆筒形套筒120释放针头套筒130，从而弹簧150可沿方向B将针头套筒130以及相关的针头336移动到外壳110的上部内，如图34A和34B所示。
在可选的实施方式中，触发装置140’可构造成由患者手动地致动，从而，一旦插管806已经完全插入，就使得针头套筒130和相关的针头336缩回。
现在参照图39-43，示出了另一个设备100”’的实施方式。设备100”’是一种手动的设备，由于设备100”’仅仅包括一个外壳110’、针头336、以及可拧到外壳110’上的盖体(未示)。优选地，一个定位贴片(未示)可预装到针头336上、且盖体放置在外壳110’上以在使用前形成一个卫生环境。为了使用设备100”’，患者优选地从外壳100’上移除盖体，并且握持住外壳110’而将针头以及定位贴片的相关插管插入皮肤中。一旦插管完全插入，患者沿相反的方向移动外壳110’，以将针头从皮肤内移去而把定位贴片留在适当的位置上。最后，患者优选地将盖体重新施加到外壳110’上，以减少针头336再无意地露出的可能。设备100”’然后可以被扔掉或根据需要重新使用。
现在参照图44-49，其示出了一个设备950的示例实施方式，该设备用于帮助定位贴片970的导入。设备950与设备100不相同。例如，设备100可以由患者手动地驱动而将针头和定位贴片的插管插入到皮肤内；而设备950是自动的，因为采用了一个弹簧960来将针头和定位贴片的插管插入到患者的皮肤内。
设备950包括一个外壳958、盖体952、锁定构件962、针头套筒965、主体980、保持体978、以及套管982。还包括有一个第一弹簧960以及一个第二弹簧966。
设备950如下地起作用。锁定构件962、针头套筒964、以及保持体978可相对于设备950的外壳958以及套管982纵向地移动。锁定构件962定位成使得：可通过设备950的开口端984而操作(accessible)针头套筒965的针头968。然后，可通过把定位贴片970的插管拧到针头968上而把定位贴片970装载到针头968上。开口986由外壳958形成，以容置不同尺寸的定位贴片970(例如，形成在定位贴片上的翼状件)。
一旦定位贴片970装载到针头968上，患者使用可通过外壳958的槽缝976而接触到的突起974，而使锁定构件962沿方向C移动，直至锁定构件962的倒钩956接合外壳958的外表面，如图49所示。在这个位置上，设备950已准备好将定位贴片970插入到患者皮肤内。
然后，设备950的套管982抵靠着患者的皮肤放置。为了开始插入定位贴片970，患者压下盖体952。一旦被压下，位于盖体952相反端上的肩部954接合锁定构件962的倒钩956，并推压倒钩956而使其彼此靠近，使倒钩956与外壳958脱离接合。当倒钩956跃过外壳958时，锁定构件962、主体980、针头套筒965、保持体978以及相关的定位贴片970可通过第一弹簧960而沿方向D移动。
设备950继续把定位贴片970移向皮肤，从而将针头968以及定位贴片970的插管导入到皮肤中。当定位贴片970的插管完全插入到皮肤中时，针头套筒965的倒钩964接合套管982的斜面972，导致倒钩964受推压而彼此靠近。当定位贴片970的插管完全插入到皮肤中时，倒钩964通过表面972而被充分地迫向内侧，从而跃过主体980的端部988，且第二弹簧966沿方向C移动针头套筒965，将针头套筒965移入由主体980形成的通道990内。
随着针头套筒965由第二弹簧966移入主体980内，针头968从定位贴片970移走，将定位贴片970留在皮肤的适当位置上。此外，保持体978保持在一个靠近套管982开口端984的位置上，使得一旦设备950从患者的皮肤处移走，保持体978保护患者，使其免于与针头968进一步接触。
依据在此描述的原理制作的设备在几个方面上可以是有利的。例如，每个设备都使得定位贴片可以容易地放置在皮肤上，优选地允许使用者通过单手操作设备而将定位贴片与设备一起放置在身体上的期望部位。
此外，在此公开的几个实施方式包括在插入定位贴片前将针头覆盖或掩盖起来的结构，这些结构还使针头在插入后将缩回到设备内，从而防止与针头的无意接触。
此外，在此公开的几个设备的实施方式可以自动地缩回针头，同时将定位贴片留在皮肤的适当位置上，从而减少了患者与露出针头的接触。优选地，这个缩回是自动的，即一旦设备到达触发状态，患者不需要任何另外的操作来导致针头的缩回。针头的自动缩回还限制了针头在患者体内的停留时间，增加了患者的舒适度。
此外，通过在此所公开的设备而将针头插入到皮肤的适当位置中的操作可在针头缩回期间将定位贴片保持在皮肤表面上。这能有助于将粘合部分粘合在皮肤上并减少了在针头缩回期间粘合部分与定位贴片和皮肤之间脱离开的可能性。
此外，在此公开的几个设备的实施方式的外壳和盖体使得设备的各个部件——包括针头和输液设备——可以在使用前在一个自容置的卫生环境下被送到患者。所述构造进一步使包绕设备所需的包装最小化，减少了制造成本并增加了设备使用的容易程度。所述构造还使得外壳和盖体可以保护输液设备并将之保持在设备的针头上。设备的所述构造及其可丢弃性进一步使得设备可在使用后被容易地丢弃。
同时，在此公开的几个设备的实施方式的构造使得定位贴片可以预装到设备内，从而使患者可以容易地使用，并减少了患者与针头的接触。例如，在此公开的单次使用的实施方式优选地不需要患者在插入之前将定位贴片装到设备中，而是提供预装有定位贴片的设备。
所述设备的有些实施方式使得可以自动地送出定位贴片以及自动地缩回针头，从而为患者自动化了整个导入过程。
虽然单次使用的设备是优选的，但是还可以设想可重新使用的设备，其中针头缩回但可重新装入。
上述的解释、示例以及数据提供了对本发明设备的完整描述。因为可以作出许多本发明的实施方式而不会偏离本发明的精神与范畴，本发明的保护范围由所附的权利要求确定。

Claims (14)

1.一种用于自动缩回针头的设备，其中所述针头用来将皮下输液设备的插管导入到患者皮肤的皮下层内，所述设备包括：
一个外壳，其限定一个内腔；
一个针头套筒，其耦合到所述外壳并包括有一个针头，所述针头耦合到皮下输液设备的插管；
一个弹簧，其构造成将所述针头移动到一个缩回状态；以及
一个触发构件，其包括突起；
其中，一旦针头以及相关联的皮下输液设备插管完全导入患者皮肤的皮下层内，所述突起就释放所述针头套筒，并且所述弹簧自动地将所述针头移入所述外壳的内腔内而将之移动到所述缩回状态，而将所述皮下输液设备的插管留在患者皮肤的皮下层内。
2.如权利要求1所述的设备，其进一步包括一个第二弹簧，所述第二弹簧构造成将所述针头以及相关联的皮下输液设备插管导入到患者皮肤的皮下层内。
3.如权利要求1所述的设备，其中所述外壳包括一个与所述针头耦合的第一部分以及一个第二部分，所述第二部分以可滑动方式容置在所述第一部分内，其中所述第一部分相对于第二部分滑动而将所述针头导入到患者皮肤的皮下层内。
4.如权利要求1所述的设备，其进一步包括用于在将针头导入到患者皮肤的皮下层内之前遮盖所述针头的装置。
5.如权利要求1所述的设备，其进一步包括一个套管，该套管耦合到所述外壳，从而在针头导入到患者皮肤的皮下层内之前遮盖所述针头。
6.如权利要求1所述的设备，其中所述设备构造成使得皮下输液设备预装在设备中。
7.如权利要求1所述的设备，其进一步包括一个耦合到所述设备外壳的盖体。
8.如权利要求7所述的设备，其中所述盖体包括一个显窃启密封。
9.一种用于将皮下输液设备插入到患者皮肤内的设备，所述设备包括：
一个外壳，
一个套筒，其耦合到所述外壳并限定一个内部通道；
一个包括针头的针头套筒，所述针头套筒定位在所述套筒的内部通道中，使得所述针头套筒相对于所述套筒以及外壳保持在一个固定的位置上；
一个套管；以及
一个与所述针头套筒接合的弹簧；
其中所述外壳、套筒以及针头套筒能够相对于所述套管移动而将所述针头套筒的针头以及相关联的输液设备插管导入到皮肤的皮下层内，并且其中，一旦所述针头以及相关联的输液设备被完全地插入到皮肤的皮下层内，针头套筒就能够相对于所述套筒滑动，并且，包括所述针头的针头套筒能够由所述弹簧移动而穿过所述套筒的通道以抵达一个缩回状态，将输液设备留在患者的皮肤上。
10.如权利要求9所述的设备，其进一步包括一个构造成耦合到所述外壳的盖体。
11.如权利要求10所述的设备，其中所述盖体包括一个显窃启带，其中，当所述盖体从外壳上移去时，所述显窃启带继续耦合到所述外壳。
12.如权利要求9所述的设备，其进一步包括另一个接合到所述针头套筒的弹簧，所述弹簧设置成将所述针头套筒的针头以及相关联的输液设备插管自动地导入到患者皮肤的皮下层内。
13.如权利要求9所述的设备，其中所述设备构造成使得所述皮下输液设备预装到所述设备内。
14.一种用于将皮下输液设备插入到患者皮肤内的设备，包括：
一个外壳，其包括一个封闭上端，限定一个开口下端、以及一个位于所述开口下端附近的螺纹部分；
一个圆筒形的套筒，其包括第一端和第二端，所述圆筒形套筒限定一个内部通道以及两个相对的槽缝，所述槽缝从该套筒的中部延伸到所述第一端，而且，所述圆筒形套筒限定了与该圆筒形套筒第二端邻近的相对孔口，其中该圆筒形套筒的第一端耦合到所述外壳的上端；
一个针头套筒，其包括一个具有第一和第二端的主体、以及一个耦合到所述主体的针头，所述主体包括形成于所述第一端处的相对翼状件以及形成于所述第二端处的相对倒钩，其中所述针头套筒定位于在所述圆筒形套筒的内部通道中，使得所述相对翼状件延伸通过所述圆筒形套筒的相对槽缝，而所述针头套筒的相对倒钩延伸通过所述圆筒形套筒的相对孔口并与该圆筒形套筒接合，使得所述针头套筒相对于所述圆筒形套筒以及外壳保持在一个固定的位置上；
一个套管，其包括第一端及第二端并限定一个内部通道，所述套管包括在该套管中部处向内延伸入所述套管内部通道中的相对突起、以及在该套管中部处形成于所述内部通道中的圆筒形的肩部，其中所述圆筒形套筒的第二端延伸穿过所述套管的通道，并且所述套管包括第一端的部分容置在所述外壳内；
一个具有第一端和第二端的弹簧，其中所述弹簧环绕所述圆筒形套筒并在所述套管的通道内延伸，并且其中所述弹簧的第一端座放在所述套管的肩部上，而所述弹簧的第二端接合所述针头套筒的相对翼状件，所述相对翼状件延伸通过所述圆筒形套筒的相对槽缝；
一个盖体，其包括一个封闭的第一端，限定一个开口的第二端、以及一个位于所述开口第二端附近的螺纹部分，其中所述盖体的螺纹部分拧到所述外壳的螺纹部分上而密封所述设备；
其中，一旦所述盖体从所述外壳上移除，所述套管的第二端就相对于患者的皮肤定位，而且，所述的外壳、圆筒形套筒、以及针头套筒相对于所述套管沿朝向患者皮肤的方向移动，使得所述针头套筒的针头以及相关联的输液设备插管导入到皮肤的皮下层内，并且其中，一旦所述的针头以及相关联的输液设备完全地插入到皮肤内且所述圆筒形套筒相对于套管移动，套管的所述相对突起就接触所述针头套筒的倒钩并朝内地压迫所述倒钩，直至所述倒钩从所述圆筒形套筒的相对孔口脱离接合，并且，其中，一旦所述倒钩从所述圆筒形套筒脱离接合，包括所述针头的针头套筒就在所述弹簧的作用下，穿过所述圆筒形套筒的通道而移至该圆筒形套筒与所述外壳的封闭上端相邻近的第一端，将所述输液设备留在患者的皮肤上。
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EP2383011A2 (en) 2011-11-02
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