CN101410145A - 药液注射器 - Google Patents

药液注射器 Download PDF

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CN101410145A
CN101410145A CNA2007800108264A CN200780010826A CN101410145A CN 101410145 A CN101410145 A CN 101410145A CN A2007800108264 A CNA2007800108264 A CN A2007800108264A CN 200780010826 A CN200780010826 A CN 200780010826A CN 101410145 A CN101410145 A CN 101410145A
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CN101410145B (zh
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塞巴斯蒂安·迈诺特
尼克劳斯·施尼博格
弗雷德里克·内特尔
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Debiotech SA
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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
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14224—Diaphragm 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
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • 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
    • A61M2005/14264—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with means for compensating influence from the environment
    • 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
    • A61M2005/14268—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body with a reusable and a disposable component
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0244—Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology

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  • Health & Medical Sciences (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
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Abstract

一种药液注射器，包括下列特征性的元件：容器(1)，排出通道(14)和抽吸单元(5)；所述容器(1)包括刚性壁，所述抽吸单元(5)刚性固定在刚性壁上；所述刚性壁进一步包括一个通道(4)，该通道在所述抽吸单元(5)和所述容器(1)之间形成直接流体连通；所述排出通道(14)以下述方式直接连接到所述抽吸单元(5)上：最初存放在所述容器(1)中的液体可先流经所述抽吸单元(5)，并随后到达所述排出通道(14)，所述药液注射器进一步包括一个不同于所述排出通道(14)的进口(16)，以及用完即弃的元件。

Description

药液注射器
技术领域
本发明涉及用于液体物质例如胰岛素的药物容器，其适用于固定在一个注射器如抽吸装置上，其在一个持续时间内控制供给病人的液体物质。
背景技术
通常由注射泵负责控制供给病人的液体药物，如胰岛素。例如参见WO 2004/084976或US 2003/055323。
液体包含在一个注射器中，它必须在治疗前预先填充好。
如果注射器是空的，就使用一个新的预先填充好的注射器。
如果第一个注射器部分是空的，也可能需要一个新的预先填充好的注射器，例如当病人希望在开始一项活动或旅行之前有一个完全满的容器。
发明内容
本发明的一个目的是减少治疗过程中使用的容器数量。
本发明的另一个目的是为了提供一种简单并舒适的方式来在一个较长时间内控制液体药物。
这些目的通过依照本发明的药物注射器来实现，其至少包括以下几个独特的元件：一个容器、一个排出通道和一个抽吸单元；所述容器包括一个刚性壁，所述抽吸单元刚性固定在其上；所述刚性壁进一步包括一个通道，其在所述抽吸单元和所述容器之间形成一个直接流体连通；所述排出通道以这样一种方式直接连接到所述抽吸单元上，从而最初存放在所述容器中的液体可先流经所述抽吸单元，并随后到达所述排出通道，所述药液注射器进一步包括一个不同于所述排出通道的进口，其适用于作为再填充装置。另外，依照本发明的该药物注射器还包括用完即弃的部分。
本发明特别具有下列优点：
-避免容器的浪费，只使用一个，
-简单并舒适的方式来控制药液不致中断，
-可以具有一个相对较小尺寸的容器。
依照本发明的该装置可以方便的用作药物输液泵。与现有技术的装置即注射器相比，依照本发明的抽吸单元在容器和病人管线之间提供一个永久性的闭塞，从而防止由病人带来的容器污染。因为容器中的物质必须保持无菌，因此可以考虑将其填充多次，一直到这样一个无菌型容器中药物的指定使用期限。在这个使用期限之后，该容器和所有其他被药物弄湿的部分最好丢弃。该装置的其他几个部分，尤其是操纵电子设备和用户界面可永久使用。
依照本发明的抽吸单元最好包括一个永久部分和一个用完即弃的部分。如上所述，该用完即弃的部分包括所有被药物弄湿的元件，即容器、抽吸单元、进口，以及用于该输液管线的连接口。这些部分可以反复连接和断开。特别是该永久部分，可重复使用多个用完即弃的部分。
附图说明
下面对本发明的一个实施例以更加详细的方式和下列附图一起讨论：
图1是一个药液注射器的横截面图。
图2是一个图1中所示抽吸单元的放大图。
图3是图1装置的一个上部透视图，具有一个弹性膜，但没有底部和上部的保护壳。
图4表示图3中的同一个对象，但没有弹性膜。
图5是一个图1中装置的底部透视图。
具体实施方式
附图中显示的药液注射器，更确切地是它用完即弃的部分，主要围绕着形成一个硬壳1的部分而构成。这个硬壳1充当结构基础及用完即弃部分功能元件之间的流体连接，同时也作为功能元件。硬壳为具有两个主要面的壳状结构，一个为凹面，从而形成一个腔2。弹性膜3围绕该腔2的所有边缘连接，将它关闭。因此，它们形成一个封闭的腔，由于膜3的弹性，该腔的体积是可变的。膜3是热力塑型的，以便当折叠进入腔2时，与腔2的形状相符，这样剩余容积是可忽略不计的。
第一通道4从腔2穿过硬壳到达相对侧，其上安装一个微流体抽吸单元5。该微流体抽吸单元5在其两个主表面之一上具有一个进口6和一个出口7。
抽吸单元5和硬壳1之间的流体连接通过将该硬壳1的第一通道4和该抽吸单元5的进口6对准来实现。通过该两表面之间的弹性O型圈很容易实现密封。
抽吸单元5通过显微机械加工技术制造。它是一个正排量泵。抽吸单元配备一个具有弹性膜9的抽吸室8，其周期性的被膜9的运动压缩和减压。液体流由连接到抽吸室的被动进口止回阀10和被动出口止回阀11引导。抽吸单元5还设置一个监测流体通道内部压力的压力传感器12。电线和电接触点连接此传感器12和致动器，该致动器驱动该膜运动至包含必要电路的永久性部分。
硬壳中的一个排出通道14将该抽吸单元5的出口7连接至一个用于输液管线的鲁尔(Luer)型连接器15上。
作为进口，第三通道16穿过该硬壳1，进入腔2并在外侧由隔膜17关闭，其允许采用如针头和注射器填充和再填充该容器。隔膜17位于输液管线连接器的旁边。输液管线上的配合连接器18的形状为当连接时，它覆盖再填充隔膜。这样做是为了防止使用者在有人连接到该设备时再填充该容器。
所描述的元件构成了用完即弃部分的主要功能结构，并被称为射流部件。
射流部件被封装在两个刚性外壳19、20之间，主要用于机械保护。尤其是弹性膜3必须得到保护，免受机械力，以防止对容器中的药物施压。在容器中压力过大的情况下，泵上的两个被动止回阀可能被迫开放且危险数量的药物可以注入病人。弹性膜3和刚性外壳20之间容积21中的压力通过一个通风口22得以平衡。进入该容积内的水通过一个疏水过滤膜23被阻止。如果此通风口被堵塞，则弹性膜3上可能会产生危险的过压力。为防止止回阀的打开，在抽吸单元上使用一个反自由流动的止回阀。如图所示该阀设有三个端口：一个连接到抽吸室8的流体进口24，一个引出该单元的流体出口7和一个参考端口25。该参考端口25与壳内侧的空气压力连通。该阀配备有一个弹性膜26，堵塞出口7的阀体27连接在其上。膜9的内侧承受进口6的压力。膜9的外侧承受该参照端口25的压力。出口压力仅存在于一个很小的表面上，因此对阀门的性能影响很小。该阀设计成只有当进口压力超过参考端口压力一个预定值时，流体通路才打开。如果壳内侧压力增加，进口和参照端口的压力就同样的增加，该阀因此无法打开。
应该强调的是，本发明并不限于上面所讨论的实施例。任何包含在权利要求主旨内的其他配置都是本发明的组成部分。

Claims (35)

1、一种药液注射器，包括下列特征性的元件：容器(1)，排出通道(14)和抽吸单元(5)；所述容器(1)包括刚性壁，所述抽吸单元(5)刚性固定在刚性壁上；所述刚性壁进一步包括一个通道(4)，该通道在所述抽吸单元(5)和所述容器(1)之间形成直接流体连通；所述排出通道(14)以下述方式直接连接到所述抽吸单元(5)上：最初存放在所述容器(1)中的液体可先流经所述抽吸单元(5)，并随后到达所述排出通道(14)，所述药液注射器进一步包括一个不同于所述排出通道(14)的进口(16)，以及用完即弃的元件。
2、根据权利要求1的药液注射器，其中所述进口(16)适用于作为再填充装置。
3、根据权利要求1或2的药液注射器，进一步包括能够和所述排出通道(14)连接和断开的一个连接器(15)及一个输液管线。
4、根据权利要求3的药液注射器，其中所述进口(16)紧邻排出通道(14)，并且形成该输液管线的连接器，从而在连接时，阻断了进入进口(16)的通路。
5、根据先前任一权利要求的药液注射器，进一步包括非用完即弃的元件。
6、根据先前任一权利要求的药液注射器，特征在于，该注射器设计成具有预先确定的使用期，其不长于所述容器内的药物标示的使用期限。
7、根据权利要求6的药液注射器，包括防止使用的装置，其适用于防止在所述预先确定的使用期后使用该设备。
8、根据权利要求5的药液注射器，其中该非用完即弃的元件包括电子控制部分。
9、根据权利要求8的药液注射器，其中所述电子控制部分适用于防止在预先确定的期限后使用该设备。
10、根据权利要求9的药液注射器，其中所述电子控制部分适用于识别该用完即弃部分的标识，以防止在所述预先确定的期限后重复使用。
11、根据权利要求9或10的药液注射器，其中所述电子控制部分适用于确定所述用完即弃部分是否先前已经被使用过。
12、根据先前任一权利要求的药液注射器，其中所述容器具有可变容积。
13、根据先前权利要求的药液注射器，其中所述容器包括一个可移动的壁，例如一个弹性壁。
14、根据权利要求12或13的药液注射器，包括一个控制元件，其防止当该容器受压时注射进入使用者。
15、根据权利要求14的药液注射器，其中所述控制元件是一个连接到所述抽吸单元、连接到所述出口并与所述容器连通的三通阀。
16、根据权利要求15的药液注射器，其中所述三通阀适用于只有当与该抽吸单元连接的口的压力高于该容器内或周围压力时，才打开。
17、根据先前任一权利要求的药液注射器，进一步包括一个压力传感器。
18、根据权利要求17的药液注射器，其中所述压力传感器适用于测量所述容器内部的液体压力。
19、根据权利要求18的药液注射器，包括显示装置，其适用于将容器填充高度传达给使用者，所述填充高度由所述压力传感器获得。
20、根据权利要求18或19的药液注射器，包括第一报警装置，以便在过量填充的情况下提醒使用者，所述第一报警装置被连接到所述压力传感器上。
21、根据权利要求18-20的任一药液注射器，包括第二报警装置，用于检测容器压力的潜在危险状态，所述第二警报装置被连接到所述压力传感器上。
22、根据权利要求18-21的任一药液注射器，包括第三警报装置，用于检测何时容器是空的，所述第三警报装置被连接到所述压力传感器上。
23、根据权利要求12-22的任一药液注射器，其中所述容器构造成一个刚性外壳，该外壳具有形成一个腔的凹面以及覆盖该腔的弹性膜。
24、根据权利要求23的药液注射器，其中所述刚性外壳包括一个连接所述容器内部和外界环境的通道。
25、根据权利要求23的药液注射器，其中所述刚性外壳包括几个通道。
26、根据权利要求23的药液注射器，其中将所述的弹性膜做成与该腔相符，以使容器在没有充分负压的情况下可以被放空。
27、根据权利要求23的药液注射器，包括一个进口，其中所述进口和所述出口设置在所述刚性外壳上。
28、根据权利要求23的药液注射器，其中所述弹性膜由一个凹形覆盖外壳覆盖。
29、根据权利要求28的药液注射器，其中所述凹形覆盖外壳是刚性的，从而限制了容器的填充容积。
30、根据权利要求23-29的任一药液注射器，其中覆盖外壳中腔的形状是该容器中腔的镜像，因此该膜在整个状态上也与该覆盖外壳相符。
31、根据权利要求28的药液注射器，在一定程度上适于，当该容器的容积改变时，为了压力平衡，弹性膜和覆盖外壳之间的容积是通风的。
32、根据权利要求28的药液注射器，其中覆盖外壳被加固以保护所述弹性膜免受机械压力。
33、根据权利要求32的药液注射器，其中所述弹性膜包括一个薄弱区域，其在危险的过压力情况下破裂。
34、根据权利要求29的药液注射器，包括位于所述弹性膜和所述覆盖外壳之间的限制装置，用于减少填充容积。
35、根据权利要求34的药液注射器，其中所述限制装置的位置可调，以便改变容积的减少量。
CN200780010826.4A 2006-03-31 2007-03-17 药液注射器 Expired - Fee Related CN101410145B (zh)

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CN103635213B (zh) * 2011-06-23 2016-11-02 生物技术公司 用于检测mems微泵的故障的方法和系统
CN105828852A (zh) * 2013-11-15 2016-08-03 艾韦尼克斯股份有限公司 包括内表面改进的泵腔室
CN105828852B (zh) * 2013-11-15 2019-12-17 艾韦尼克斯股份有限公司 隔膜泵
CN106103994A (zh) * 2014-01-07 2016-11-09 洛基研究公司 溶液泵系统
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AU2007232227B2 (en) 2011-05-19
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CN101410145B (zh) 2014-04-16
CA2647355A1 (en) 2007-10-11
ES2338935T3 (es) 2010-05-13
US20110054397A1 (en) 2011-03-03
AU2007232227A1 (en) 2007-10-11
EP2001533A1 (en) 2008-12-17
ES2338935T5 (es) 2020-03-25
WO2007113708A1 (en) 2007-10-11
JP2013013748A (ja) 2013-01-24
CA2647355C (en) 2014-05-27
DE602007004458D1 (de) 2010-03-11
JP5199232B2 (ja) 2013-05-15
EP2001533B2 (en) 2019-07-10
EP1839695A1 (en) 2007-10-03
ATE455567T1 (de) 2010-02-15
EP2001533B1 (en) 2010-01-20

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