CN101790394B - 具有两个弹簧的插入器 - Google Patents

具有两个弹簧的插入器 Download PDF

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CN101790394B
CN101790394B CN2008800239335A CN200880023933A CN101790394B CN 101790394 B CN101790394 B CN 101790394B CN 2008800239335 A CN2008800239335 A CN 2008800239335A CN 200880023933 A CN200880023933 A CN 200880023933A CN 101790394 B CN101790394 B CN 101790394B
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J·E·尼尔森
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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
    • A61B5/14532—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
    • A61M2005/1585—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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient 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
    • A61M5/178—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

本发明涉及一种用于医用装置的插入器，该医用装置为例如用于间断或连续施用诸如胰岛素的治疗药物的输注套装或类似装置。该插入器包括针座和两个弹性元件，其中该针座包括插入针头，所述两个弹性元件确保插入针头自动插入和自动缩回。第一弹性元件(11)的触发使穿透构件(6A)在皮下或经皮插入患者的皮肤，第二弹性元件(12)使穿透构件(6A)从患者的皮肤中缩回。第一弹性元件(11)在触发之前处于未加载状态，并在触发的情况下给第二弹性元件(12)提供能量。

Description

具有两个弹簧的插入器
技术领域
本发明涉及一种用于医用装置的插入器，该医用装置为比如用于间断地或连续地施用诸如胰岛素的治疗药物的输注套装或类似装置。该插入器包括针座和两个弹性元件，其中该针座包括插入针头，所述两个弹性元件确保插入针头自动插入和自动缩回。
背景技术
WO 2005/046780(图97-102)描述了一种用于使输注装置的插管自动插入患者皮肤然后使插入针头自动缩回的装置。该插入装置具有长圆筒的形式，该长圆筒的一端(1984)开口，另一端(1952)设置有用于触发的装置。当输注套装已经装载在针头(1968)上时，患者使用突出件(1974)使锁定构件(1962)朝着设置有用于触发的装置的端部的方向移动，直到锁定构件(1962)的倒钩(1956)接合壳体的外表面(第26页第24-27行)。可以穿过壳体的狭槽(1976)接近突出件(1974)。然后将开口端(1984)放置在患者皮肤上，并触发用于触发的装置(1952)。当用于触发的装置上的已触发肩部(1954)接合时，倒钩(1956)被推向彼此，从而使倒钩从壳体上脱离。当倒钩离开壳体时，锁定构件、针座、保持件本体和关联的输注装置在第一弹簧的作用下朝着开口端(1984)的方向移动。该插入器装置使输注装置向着患者皮肤移动，从而插入针头和输注装置的插管。当插管完全插入时，针座(1965)的倒钩(1964)接合套管(1982)的斜面(1972)，从而强制倒钩(1964)彼此相向地移动。当倒钩(1964)已经被强制移动到足够向内而脱离主体(1980)的端部(1988)时，第二弹簧(1966)随后使针座(1965)朝着触发装置(1952)的方向移动。由此将针头从输注装置上取下，将输注装置留在皮肤上的适当位置，同时保持件本体保持在与套管开口端相邻的位置上，使得一旦插入装置从患者皮肤上移走，该保持件本体就保护患者不会进一步接触该针头。
该插入装置相当复杂，并且由于形成该装置的功能部件的各个单元或多或少必须首尾相接地放置，所以该装置的长度由这些单元限定。表明该单元的复杂性的特征是以下事实：两个弹簧分别使壳体偏离锁定构件和使保持件本体偏离针座，同时主体位于两个弹簧系统之间以将力从第一弹簧传递至第二弹簧。
US 5 176 643公开了一种用于尤其是通过成人胸骨或小儿胫骨进行快速血管药物输送的装置。在使用时，装置(10)被放置成前圆筒(18)的端部放置在胸骨的中线上，然后该装置(10)被推靠在胸骨上。当前圆筒(18)被推向致动把手(22)时，注射器本体(12)后面的弹簧(34)发生压缩，该压缩产生将用于针头(14)前进和药物(32)注射的力。当弹簧(34)中存储了足够的力时，前圆筒(18)已经被推回到使得锁定球(44)能够进入释放袋(46)中的位置上。这种进入将锁定球(44)释放，使得主弹簧(34)可以利用大约25至大约40磅的力向前驱动注射器本体(12)和针头(14)，直到轴环(40)靠在脊部(50)上。然后主弹簧(34)向前推动注射器柱塞(26)以通过延伸的针头(14)将药物(32)输送至胸骨中的红骨髓。在完成药物输送的情况下，操作者释放对胸骨的压力，针头缩回弹簧(38)将针头(14)缩回到主壳体(16)的圆筒(18)中。
根据该装置，注射针头在插入之后不是自动缩回，而是注射针头位于胸骨内直到使用者将该装置从患者身上移走。
根据本发明，因为第一弹簧单元直接影响载体的移动，同时第二弹簧系统直接受载体的移动的影响，所以两个弹簧单元直接一起工作。弹簧单元直接影响载体或直接受载体的影响意味着弹簧单元直接地与载体连接或通过不变地或在受控的改变下传递能量的部件与载体连接。
发明内容
本发明的目的是提供一种简单不贵的用于输注装置的插入器，对于使用者而言该插入器在使用期间能够简单和安全地操作并在使用之后能够安全地处置。
本发明涉及一种用于医用装置的插入器，该插入器包括两个弹性元件，其中第一弹性元件的触发使穿透构件在皮下或经皮插入患者的皮肤，第二弹性元件使穿透构件从患者的皮肤中缩回，其中第一弹性元件在触发之前处于未加载状态，并在触发的情况下给第二弹性元件提供能量。第一弹性元件处于未加载状态意味着它没有被偏压或稍微被偏压，并且仅仅在触发的情况下被加载。这确保了第一弹性元件不会在使用前的存储期间失效。
根据本发明，第一弹性元件具有两个功能，它将穿透构件与医用装置一起注入，同时它给第二弹性元件提供能量，从而使得第二弹性元件能够导致穿透构件缩回并将医用装置留在患者皮肤上。
根据本发明的一个实施例，第一弹性元件是具有弹簧常数k1的弹簧。
根据本发明的上述实施例或另一个实施例，第二弹性元件是具有弹簧常数k2的弹簧。
根据本发明的一个实施例，第一弹性元件的弹簧常数k1比第二弹性元件的弹簧常数k2大，通常弹簧常数k1≥2×k2。
根据一个实施例，弹簧常数k1≥0.2，弹簧常数k2≥0.09。
根据一个实施例，第一弹性元件和/或第二弹性元件是螺旋弹簧。
根据本发明的一个实施例，该插入器包括
-静止部(10)，其靠在患者皮肤上并且在插入期间相对患者是静止的，
-触发装置(1)，
-载体(2)，其相对于静止部(10)具有向前位置和缩回位置，
-针座(6)，其与穿透构件(6A)连接，
-第一锁定装置(4)，其将载体(2)锁定在缩回位置，
-第一释放装置(13A)，其将载体(2)从缩回位置解除锁定，
-第二锁定装置(8、9)，其将针座(6)相对于载体(2)锁定在向前位置，
-第二释放装置(15A)，其将针座(6)从向前位置解除锁定，
其中第一弹性元件(11)对壳体(1)的表面和载体(2)的表面施加力，第二弹性元件(12)对针座(6)的表面和静止部(10)的表面施加力。
根据这一实施例，壳体可以是触发装置，当第一弹性元件被触发时载体在壳体内从缩回位置移动到向前位置。
根据这一实施例，第二释放装置在针座通过某一位置时自动地将该针座从载体上释放，例如该释放装置可以是静止部的一部分。
根据这个实施例，包括第一弹性元件的第一整体部分可以与包括第二弹性元件和穿透针头的第二整体部分分开，例如第一整体部分可以再次使用，第二整体部分是一次性的。
本发明还涉及如上所述的插入器的应用，所述插入器用于在皮下或经皮定位用于计量物质例如血液葡萄的糖含量的单元和/或用于在皮下或经皮定位用于给患者输送诸如胰岛素的药物的输注套装的输注部件和/或用于在皮下或经皮定位用于代替多次注射的流道装置。
附图说明
下面参考附图对本发明进行更详细的解释，其中附图示出了本发明的优选实施例。
图1A和1B为载体和医用装置在插入之前处于缩回位置的实施例的侧视图，图1C为相同位置的立体侧视图；
图2A和2B为载体和医用装置在插入之前处于缩回位置的实施例的侧视图，图2C为相同位置的立体侧视图；
图3A和3B为载体和医用装置处于完全向前位置的实施例的侧视图，图3C为相同位置的立体侧视图；
图4A和4B为载体处于向前位置，医用装置处于缩回位置的实施例的侧视图；图4C为相同位置的立体侧视图；
图5A和5B为载体和医用装置在插入之后处于缩回位置的实施例的侧视图，图5C为相同位置的立体侧视图；
图6为可以与插入器装置一起使用的医用装置的俯视图。
具体实施方式
图1A、1B和1C所示的插入器装置的实施例处于医用装置插入之前的状态。该实施例包括壳体1、载体2、在使用期间相对于患者静止的静止部10和设置有穿透构件6A的针座6。该插入器装置还包括为两个弹簧单元形式的两个弹性元件，即具有弹簧常数k1的插入弹簧11和具有弹簧常数k2的缩回弹簧12。
插入弹簧11对壳体和载体2施加压力，即当插入弹簧11的长度减小时，其在壳体1上施加向上压力并且在载体上施加向下压力，从而将这两个部件相互推开。缩回弹簧12对针座6和静止部10施加压力，即当缩回弹簧12的长度减小时，其在针座6上施加向上压力并且在静止部10上施加向下压力(向上/向下是相对于图中所示的实施例而言)。
壳体1具有圆筒形本体，该圆筒形本体具有闭合的远端和开口的近端，并且在壳体1本体的相对两侧上设置有两个纵向孔13；这些孔朝向远端处由边缘13A限定，朝向近端处由边缘13B限定。壳体1还设置有从壳体1的近侧边缘延伸的四个狭槽13C，在各纵向孔13的每一侧均有一个狭槽。
静止部10也具有圆筒形本体，该圆筒形本体装配在壳体1的本体内。静止部10包括一对相对地定位在该圆筒形本体的远端的向外的臂4，和用于释放插入器装置的可更换部的装置，该装置是向内的臂5的形式，比向外的臂4更靠近静止部10主体的近端。静止部10还设置有具有突起部15A的突起圆形边缘15。
臂5上的突起部的下侧或近侧提供静止部10和壳体1之间相对运动的止动件，即不可能在相对设置的臂5处于松弛位置时将静止部10推出壳体1。当臂5被相向推动时，臂5处于张紧位置，并且能够将静止部10推出壳体1并将静止部10替换为新的例如未使用过的部件或者例如具有另一种功能或附接有不同医用装置的部件。狭槽13C允许壳体1的直径增加，这种增加使得可以在不破坏壳体1的情况下从所示实施例的壳体1上移除静止部10。使用后，图中所示实施例的载体2将被卡在静止部10内，因此载体2将和静止部10一起被移除。
载体2也包括圆筒形本体，该圆筒形本体的远端具有比圆筒形本体的近端增大的直径。载体的圆筒形本体的远侧部分具有一表面，插入弹簧11靠在该表面上，静止部10的向外的臂4也靠在载体2的一表面上。载体2在圆筒形本体近侧部分的相对位置上设置有两个纵向孔7，该纵向孔7作为针座6的突起部6B的引导装置。该纵向孔确保针座6在载体2内仅仅可以移动与孔7对应的一定距离。载体2还设置有具有孔的闭合的近侧出口，该孔的大小正好足以允许穿透构件穿过。这一几乎闭合的端部防止使用后接近被污染的穿透构件。图中所示实施例还具有两个孔，这两个孔与孔7垂直并从载体2的圆筒形本体的近端延伸。静止部10的突起圆形边缘15的突起部15A伸入到这些孔中，并且在载体2相对于静止部10移动时沿着孔被引导。当载体2相对于静止部10处于最向前的位置时，载体2的近端表面接触患者的皮肤。当载体2相对于静止部10处于最缩回的位置时-即图1A、1B和1C中所示的状态-静止部10的向外的臂4的向内突起部靠在载体2的圆筒形本体远侧部分的一表面上。
使用之前针座6放置在载体2的圆筒形本体的远侧部分内。针座6的远端设置有两个突起部6B，这两个突起部6B位于针座6的圆筒形本体上的相对位置上(图1B中所示)，并且如上所提及的，纵向孔7确保针座6在载体2内仅仅可以移动与孔7的长度对应的一定距离。该针座还包括具有钩的可枢转地安装的臂8，在缩回位置所述钩接触载体2的近侧翻转表面(turned surface)9。该近侧翻转表面9是孔的远侧边缘。
图2A、2B和2C示出了处于以下状态的插入器装置：插入弹簧11被压缩并因此受到偏压，但是处于载体2和针座6向前运动之前。
如图2A中的箭头所指示的，静止部10的向外的臂4受到向外的压力的影响，该压力由向外的臂4和孔13的远侧边缘13A之间的接触产生。当向外的臂4的倾斜表面靠在壳体1中的孔13的远侧边缘13A上滑动时，所述接触导致臂4彼此远离移动。当静止部10的向外的臂4不与孔13的远侧边缘13A接触时，被压缩的插入弹簧11将在载体2和针座6上施加向下的力，针座6此时锁定在载体2上。
载体和针座6的组合向下移动使插入器装置处于图3A、3B和3C中所示的状态。
图3A、3B和3C示出了处于以下位置的针座6：穿透构件6A完全插入患者皮肤中。当在针座6的突起部6B上向上推的缩回弹簧12的弹簧常数k2比在载体2上向下推的插入弹簧11的弹簧常数k1小时，缩回弹簧12已经被压缩并因此被提供了能量。通常，插入弹簧11的弹簧常数k1等于或大于0.25N/mm，缩回弹簧12的弹簧常数k2等于或大于0.1N/mm。载体2的圆筒形本体的远侧部分在静止部10的向外的臂4之间穿过之后，向外的臂4回复就位，载体2的远侧部分此时位于臂4之间，而不是如图2中所示的位于臂4的上方。载体2、静止部10和壳体1在该位置都处于接触患者皮肤的水平高度。具有一倾斜表面的针座6的可枢转地安装的臂8在该位置已经被突起圆形边缘15的突起部15A强制向内移动。该向内的移动是由臂8向下移动时静止的突起部15A接触枢轴安装的臂8而产生的。
图4A、4B和4C示出了处于以下状态的插入器装置：针座6处于穿透构件6A从患者的皮肤完全缩回的位置。缩回弹簧12已经尽可能向上推针座6使针座6尽可能地远离患者，因为针座6的突起部6B在该位置处将与载体2的远侧部分的一表面接触，所以针座6仅可以移动至载体2的近侧部分的上端。
图5A、5B和5C示出了处于以下状态的插入器装置：针座6、载体2和静止部10定位成如图4中所示，但是在图5中使用者已经释放了在壳体1上的压力，因此壳体已经跳回到与图1中相同的位置，在该位置插入弹簧11处于松弛状态。
当使用插入器装置时，图中未示出的医用装置放置在穿透构件6A上或与穿透构件6A连接，如果例如该医用装置的直径比静止部10的内圆周小，则放置在静止部10内部，或者如果该医用装置的直径比静止部10的内圆周大，则部分地放置在静止部10的近端内部和部分地围绕静止部10的近端。
图6示出了可以用在图1-5所示的插入器装置中的医用装置的俯视图。该医用装置是端口型的，因此仅仅提供利用例如注射器接触患者血液而不必一次又一次穿透患者皮肤的入口。该医用装置包括安装垫20，该安装垫20具有通常被保护性释放层覆盖的粘性表面。图6中只能看到释放层的把持部25，该把持部25用于在临使用前移除释放层。该医用装置还包括本体21，该本体21设置有用于安装静止部10的轨道22、用于允许载体2进入的轨道23和用于针座6的穿透构件6A的贯通孔24。所示的实施例具有与静止部10上的突起端部对应的三个部分圆形轨道22。轨道22和静止部10的突起端部之间的紧密配合通常足以在插入之前将医用装置在静止部上保持就位。医用装置的本体21还设置有能够接收载体2的近端的圆形轨道23。当载体2朝着患者的皮肤向前移动时，载体2进入轨道23，轨道23不需要与载体2的近端紧密配合，仅仅需要提供引导以便使穿透构件6A恰好进入正确的位置即贯通孔24。
如果医用装置设置有从该医用装置的近侧延伸的插管，那么该医用装置必须在插入之前紧固在插入器装置上以便在皮下安装该插管，并且在这种情况下，医用装置将通过以下方式安装：当将插入器装置和医用装置交付给使用者时，针座6的穿透构件6A放置在软插管内，或者如果医用装置设置有硬的自穿透插管，则可以将医用装置与针座6连接地交付给使用者或者使用者可以打开已消毒医用装置的包装并将该医用装置与针座6连接。
如果医用装置没有设置插管，那么可以在插入之前将该医用装置紧固到患者皮肤上。插管随后将-不论它是硬的自穿透插管还是软插管-与针座6一起设置为例如PCT申请PCT/DK2006/000737中所示的独立插管部(1b)。
如果医用装置设置有软插管，那么该医用装置将作为插入器装置的整体部分交付给患者。当插入器装置已经被拆开包装并且准备使用时，从安装垫20上移除释放层，而后将连接到插入器装置上的医用装置放置在患者的皮肤上。然后使用者朝着患者皮肤推动插入器装置的壳体1，由此启动插入程序。这样一种推动使得针座和与该针座连接的医用装置以及穿透构件6A插在皮下，之后穿透构件6A自动缩回并置于载体2内。然后使用者可以从医用装置上移除插入器装置，留下医用装置完全作用在患者皮肤上。
插入器可以构造成具有第一整体部分，该第一整体部分包括一组可以再次使用的元件。该第一整体部分通常将包括壳体1，该壳体1于是可以制造得更耐用并且设置有更精致且昂贵的外观和细节部分。通常该第一整体部分还将包括第一弹性元件11，因为该元件的质量可以制造得更昂贵。该第一整体部分将与为不能再次使用的第二整体部分形式的一组元件结合。该第二整体部分例如将包括插入针头和与插入针头结合的部件例如第二弹性元件。
该插入器可以用于在皮下或经皮定位用于计量物质例如血液葡萄的糖含量的单元和/或用于在皮下或经皮定位用于给患者输送诸如胰岛素的药物的输注套装的输注部分和/或用于在皮下或经皮定位用于代替多次注射的流道装置，该流道装置为例如在国际专利申请PCT/DK2006/050005中公开的装置并且该流道装置以引用的方式并入本申请中。该插入器还可以用于插入在PCT/DK 2006/00737的例如图32-36中公开的插管装置，由此该插管装置以引用的方式并入本申请中。
  附图标记列表
  壳体  1
  载体  2
  静止部的向外的臂  4
  静止部的向内的臂  5
  针座  6
  穿透构件  6A
  针座的突起部  6B
  载体中的纵向孔  7
  与载体2中的孔7垂直的孔
  针座的可枢转地安装的臂  8
  载体的近侧翻转表面  9
  静止部  10
  插入弹簧F1  11
  缩回弹簧F2  12
  壳体中的纵向孔  13
  壳体中的孔的远侧边缘  13A
  壳体中的孔的近侧边缘  13B
  壳体中的狭槽  13C
  针座的可枢转的臂  14
  静止部的突起圆形边缘  15
  突起圆形边缘的突起部  15A
  安装垫  20
  医用装置的本体  21
  医用装置中的用于静止部的轨道  22
  医用装置中的用于接收载体的孔  23
  用于穿透构件的贯通孔  24
  释放层的把持部  25

Claims (14)

1.一种用于皮下或经皮定位医用装置的插入器，包括：
-壳体(1)，
-两个弹性元件(11、12)，其中第一弹性元件(11)的触发使穿透构件(6A)在皮下或经皮插入患者的皮肤，第二弹性元件(12)使所述穿透构件(6A)从患者的皮肤中缩回，其中所述第一弹性元件(11)在触发之前处于未加载状态，并在触发的情况下给所述第二弹性元件(12)提供能量，
-静止部(10)，其靠在患者皮肤上并且在插入期间相对患者是静止的，
-触发装置(1)，
-载体(2)，其相对于所述静止部(10)具有向前位置和缩回位置，以及
-针座(6)，其与所述穿透构件(6A)连接，
-第一锁定装置(4)，其将所述载体(2)锁定在缩回位置，
-第一释放装置(13A)，其将所述载体(2)从缩回位置解除锁定，
其特征在于，所述插入器还包括第二锁定装置(8、9)和第二释放装置(15A)，所述第二锁定装置(8、9)将所述针座(6)相对于所述载体(2)锁定在向前位置，所述第二释放装置(15A)将所述针座(6)从向前位置解除锁定。
2.根据权利要求1所述的插入器，其中所述第二释放装置(15A)在所述针座(6)通过某一位置时自动地将所述针座(6)从所述载体(2)上释放。
3.根据权利要求2所述的插入器，其中所述第二释放装置(15A)是所述静止部(10)的一部分。
4.根据权利要求1所述的插入器，其中所述第二锁定装置(8、9)包括具有钩的可枢转地安装的臂(8)，在所述缩回位置所述钩与所述载体(2)的近侧翻转表面(9)接触。
5.根据权利要求4所述的插入器，其中所述可枢转地安装的臂(8)具有倾斜表面，所述可枢转地安装的臂(8)在一位置处被突起圆形边缘(15)的突起部(15A)强制向内移动，所述载体(2)、所述静止部(10)和所述壳体(1)在所述一位置都处于接触患者皮肤的水平高度。
6.根据权利要求1所述的插入器，其中待定位的所述医用装置设置有从所述医用装置的近侧延伸的插管，所述插管为软插管或硬的自穿透插管，或者所述医用装置没有设置插管，那么所述医用装置在插入之前紧固到患者皮肤上，同时独立的插管部被保持在所述插入器内，所述插管部包括具有将流体引导至插管的贯穿开口的主体，插管延伸超过所述医用装置的基板的近端侧。
7.根据权利要求1所述的插入器，其中所述第一弹性元件是具有弹簧常数k1的弹簧(11)，所述第二弹性元件是具有弹簧常数k2的弹簧(12)，且所述第一弹性元件的弹簧常数k1比所述第二弹性元件的弹簧常数k2大。
8.根据权利要求7所述的插入器，其中k1≥2k2。
9.根据权利要求8所述的插入器，其中弹簧常数k1≥0.2，弹簧常数k2≥0.09。
10.根据权利要求1所述的插入器，其中所述第一弹性元件和/或所述第二弹性元件是螺旋弹簧。
11.根据权利要求1所述的插入器，其中所述第一弹性元件(11)对所述壳体(1)的表面和所述载体(2)的表面施加力，所述第二弹性元件(12)对所述针座(6)的表面和所述静止部(10)的表面施加力。
12.根据权利要求11所述的插入器，其中所述壳体(1)是所述触发装置(1)，当所述第一弹性元件(11)被触发时所述载体(2)在所述壳体(1)内从缩回位置移动到向前位置。
13.根据权利要求12所述的插入器，其中包括所述第一弹性元件(11)的第一整体部分(1、11)能够与包括所述第二弹性元件(12)和穿透针头的第二整体部分(2、6、10、12)分开。
14.根据权利要求13所述的插入器，其中所述第一整体部分(1、11)能够再次使用，所述第二整体部分(2、6、10、12)是一次性的。
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ATE499128T1 (de) 2011-03-15
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RU2010104457A (ru) 2011-08-20

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