CN1127660A - 注射器 - Google Patents

注射器 Download PDF

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Publication number
CN1127660A
CN1127660A CN95117668.4A CN95117668A CN1127660A CN 1127660 A CN1127660 A CN 1127660A CN 95117668 A CN95117668 A CN 95117668A CN 1127660 A CN1127660 A CN 1127660A
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syringe
reservoir
syringe needle
needle
sleeve pipe
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雷诺·阿莱克斯
保尔·翰德威尔
翰西尔·泰吉克
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F Hoffmann La Roche AG
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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
    • A61M5/178—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
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/148—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons flexible, e.g. independent bags
    • 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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/14252—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with needle insertion 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • A61M2005/1426—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type with means for preventing access to the needle after use

Abstract

一种注射器，包括带有活性生物质储液器的套管，一个与储液器相连通的针头，一个用于插入针头的机构和一个通过针头将储液器内物质排出的注射泵。其中针头11在凸出套管下端长达注射所需深度的位置与套管相对固定，并被一个保护元件5，24所包围，借助弹力驱动，该保护元件可以从充分凸出套管下端直至超过针头长度的极端位置，移动缩回到套管下端内的另一极端位置处。

Description

注射器
本发明涉及一种注射器。它包括一个和患者皮肤有接触面的套管和一个安装在套管中的向肌内注射用的针头。
对于本篇的叙述来说，“注射”包含有两种情况：相对快的注射(大剂量)和慢的注射(有时也被称作输液或滴注)。
上述类型的注射器可从EP-A-272530的文献中得到。这个专利说明书中描述了这种注射器的各种实施例，它们利用了不同种类的储液器和不同的注射泵。但所有这些注射器的一个共同特点就是他们的机械构造要求器械有特定的最小总高度。而非常小的总高度又是作用于患者身体上的器械合格与否的一个关键因素。
现有注射器的另一个缺点在于，针头插入患者皮肤，针头和储液器之间的液体连接管是断层倾斜的。这样一方面为允许针头与储液器之间相对运动，连接管势必相当复杂。这就引出消毒和诸如热敏制剂无菌注射两方面的问题。而且这种复杂的连接管容易断裂，高成本也使得该器械不适合做一次性使用。另一方面，如果针管和储液器被固定连接，则在针头进入肌肤内时，整个储液器被加速，这就需要更大的推动力，因此这种方法是不实惠的。然而这些可处置的或一次性使用的器械在医疗方面是有很多好处的。避免注射液过早地排放，或相反地避免吸入少量的血液、组织液等类似物是很困难的。
最后，现有的注射器仍然还没有找到简单可行的方法，避免在注射完成之后把注射器拨出人体时损坏针头。
因此，需要有一种克服上述缺点的注射器。
要解决的问题一方面是要改进注射器的各组成部分，另一方面是改进各部分的组合，以达到减小总高度，简化机械操作，避免损坏针头。
本发明的目的是提供一种能克服上述缺点的注射器。
本发明提供了一种注射器，包括一个有与患者皮肤接触表面的套管和一个安置在套管中用于刺入肌肤导入注射液的针头，针头相对于套管固定，并被一个保护元件包围，该保护元件可在突出超过针尖的第一端位与缩入套管使针头伸出接触表面的第二端位之间作轴向移动，且其中有一个驱动装置使保护元件进行轴向移动。
图1是本发明一个实施例的注射器装置的剖视图。
图2是本发明另一实施例的剖视图。
参考附图所描述的示范性实施例是一种可由患者自己设置及操作使用的注射器。这种类型的注射器是已知的。其目的是基本无痛地插入注射器针头，以避免许多患者本能的惧怕。插入针头是通过本发明中的弹性推动装置来完成的。
与现有的此种注射器相反，在本发明的注射器中，当针头被弹性推动装置推入时，针头并没有相对于套管和储液器向患者肌肤方向运动，而是肌体向着储液器和套管的针头移动。包围着针头并凸出子于套底端的保护环使皮肤远离针头并处于压力之中。为插入针头，保护环通过弹力被收缩回套管，因此而暴露的肌肤相对地向针头移动并被其顶端穿入，肌肤在被针头刺透的过程中出乎意料地被大大加速。这种针头的刺透方式实际上是无痛的，并能刺入比现有器械所能刺入的更深的深度。
图1展示了这种注射器的剖面图，包括一个套管，其有盘状的底盘1和可相对旋转的帽2。在底盘的下面有一个环形的粘合层3以确保注射器固定于患者皮肤H。底盘1有一个中央同心口4，圆柱状的保护套5设置在此口中，它可在图中所示的延伸位置和虚线所示的和收缩位置之间轴向运动，在收缩位置，套筒5的下端面与底盘1在同一平面上。
为了轴向运动，保护套5与一组双臂式长形杆6的一端相连，如三个杆，其中之一如图1所示，杆6的旋转中心位于固定在帽2上的支撑物7上在图示的位置中杆的另一端延伸进入卡槽8。被压缩在不工作位置的螺旋弹簧9，通过短活塞10向杆6的锁定端施加弹力。
针头11设置在开口的中心并座落于夹持件12上，而夹持件12与扁平的大致圆柱形的柔性储液器13的一面相连形成一结构单元。储液器靠着下框架，该架包括一个由支撑物7支持的板14。储液器13，针头夹持件12和针头11相对于套管固定。针头11超过底盘一个需要插入的深度。保护套的尺寸及设定位置应使在不工作位置其足以超出针头11之外，从而避免与针尖的不小心接触。
注射器为保护针头而处于延伸状态的保护套筒5，由粘合层3固定到患者皮肤H上的指定或合适的位置。保护套筒5使皮肤H以所示的方式离开底盘。
卡槽8通过相对于底盘1旋转帽2来释放。然后弹簧和活塞向下压释放状态的杆臂，另一杆臂则将套筒带入虚线位置，即将其收入套管于是，暴露的皮肤H则向底盘移动而被针尖刺入，使针头11进入皮肤。
储液器13中的液体利用旋转环17由针头注入病人肌肤，而旋转环17借助于齿轮16由一个包含主动轮如钟表机构的电机15驱动。安装在公共轴18上的一对辊19，20在旋转环17外以均匀的角度间隔布置。外辊19在形成于帽2内侧的台肩21上滚动。而内辊20在位于压力盘23上的楔形斜面22上滚动。通过旋转环17不停转动的方式，压力盘23缓慢地向下移动，压迫储液器将其中的药液输入针头管。
如果辊子不在斜面上滚动，旋转环和压力盘上可形成在相反方向相互面对的斜面，这种结构较为简单，但不利之处在于因为滑动摩擦所需的力要大于滚动摩擦所需要的力。
另一种排出储液器液体的方法是例如使用一造气室，以在特定的时间里向储液器施加压力。别的驱动装置或已知类型的储液器均可利用。
储液器中的液体排出可以是连续不断的，也可根据需要的量、活性物质的浓度或其它参数来确定。为此，针头11可与也被插入体内且用于胰导素，葡萄糖等的微量传感器连接。也可将插入或远离注射器的带有附助针头的传感器放在合适的位置进行测量。所以，电机应有控制装置和设施以接收传感器信号。
在注射器拨出人体之前，帽可辅助性的转动以使杆的端部移回卡槽8，保护管被重新延伸到保护针头的位置。
图2与图1中相应的部分采用相同的标号。图2实施例中没有保护环；而注射器的底板24为一杯形弹簧的形状，其由压力元件25弯成预拉伸状态(由虚线表示)，使其凸出高于针尖以免意外的接触针尖。当压力元件25被放松时，底板24猛地进入其平的不起作用的位置，使患者肌肤以与前述实施例的相同的方式向着针头移动。
在这个实施例中，形成注射器底板的杯簧可在离开患者肌肤之前通过压力元件回到预拉伸位置，从而保护针头。
图2所示的实施例还显示了另一种关于利用旋转环27移动压力盘26的方法。该环上有一个均匀分布着三个圆孔29的凸缘28。每个孔里含有两个圆球30和31。上圆球30靠在固定在套管上的台肩32上，下圆球31在斜面33上滚动斜面33的倾斜表面上有一遂道形凹槽，以引导圆球31。与第一实施例的描述相同，压力盘26通过连续转动环27而缓慢向下移动。压迫储液器，使其内的液体流出针头。
图2还揭示了对针头11和储液器13内液体无菌要求的解决方法。为此，针头11的保护套34被整体形成于针管支持物或储液器上。最好针头11和支持物12模塑在一起，并且保护套34和储液器13同时成形。此外，储液器被形成并充入注射液，针头和其支持物被定位，且储液器被密封，这一连续过程被称为吹塑—填充—密封技术。在将注射器放到患者皮肤上之前，把保护套从针头11上除去，为此保护套34和针管支持物12之间有一分裂点35。

Claims (11)

1.一种注射器，包括一个有与患者皮肤接触表面的套管和一个安置在套管中用于刺入肌肤导入注射液的针头，其特征在于：针头相对于套管固定，并被一个保护元件包围，该保护元件可在突出超过针尖的第一端位与缩入套管使针头伸出接触表面的第二端位之间作轴向移动，且其中有一个驱动装置使保护元件进行轴向移动。
2.根据权利要求1所述的注射器，其特征在于：装储注射液的储液器安置在与针头相连的套管内，并有一个通过针头排空储液器内液体的泵。
3.根据权利要求1所述的注射器，其特征在于：包括一种连接注射液供给线路的连接机构。
4.根据权利要求1—3所述的注射器，其特征在于：保护元件是一个通过弹力驱动装置可移动到一伸出套管的端位和完全嵌入套管内的另一端位的圆柱筒。
5.根据权利要求1—3所述的注射器，其特征在于：保护元件包括一个杯状弹簧形成的套管底板，通过压力元件使之成预拉伸形状，凸出超过针尖。
6.根据权利要求1—5所述的注射器，其特征在于：接触面和任选的保护元件具有粘合层。
7.根据权利要求1—3所述的注射器，其特征在于：储液器是一个扁平的圆柱形柔性容器。
8.根据权利要求7所述的注射器，其特征在于：针头和储液器，保护套构成一个完整的部件。
9.根据权利要求8所述的注射器，其特征在于：由针头、储液器和保护套构成的部件，是由一种称为“吹制一充填一密封”(blow-fill-seal)的技术制造的。
10.根据权利要求1所述的注射器，其特征在于：它包括一个传感器。
11.根据权利要求8所述的注射器，其特征在于：注射器是可再封闭的，上述的部件是可替换的。
CN95117668.4A 1994-10-28 1995-10-26 注射器 Pending CN1127660A (zh)

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EP (1) EP0709104B1 (zh)
JP (1) JP3715698B2 (zh)
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AT (1) ATE163864T1 (zh)
BR (1) BR9504590A (zh)
CA (1) CA2159052C (zh)
DE (1) DE59501597D1 (zh)
DK (1) DK0709104T3 (zh)
ES (1) ES2115305T3 (zh)
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ATE163864T1 (de) 1998-03-15
ES2115305T3 (es) 1998-06-16
FI955158A (fi) 1996-04-29
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US5931814A (en) 1999-08-03
FI112439B (fi) 2003-12-15
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CA2159052A1 (en) 1996-04-29
FI955158A0 (fi) 1995-10-27

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