CN1482932A - 带有电子控制单元的笔型注射器 - Google Patents

带有电子控制单元的笔型注射器 Download PDF

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CN1482932A
CN1482932A CNA018211402A CN01821140A CN1482932A CN 1482932 A CN1482932 A CN 1482932A CN A018211402 A CNA018211402 A CN A018211402A CN 01821140 A CN01821140 A CN 01821140A CN 1482932 A CN1482932 A CN 1482932A
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injection device
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syringe
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克里斯托弗·M·兰利
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沙恩·A·戴
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罗伯特·F·维齐
罗伯特·伍斯顿
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • 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
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    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • A—HUMAN NECESSITIES
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    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
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    • 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
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
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    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/01—Motorized syringe

Abstract

本发明公开了一种注射装置，这种注射装置具有一主壳体(4)，并包括一驱动机构(42)，用于选择性地将一定剂量的药剂从一药剂筒(40)中、经一针头单元(22)推送出去；并包括一电子控制单元，用于对驱动机构(42)进行控制。该注射装置还包括一初给按钮(26)，其能向电子控制单元发送一初给信号，电子控制单元在接收到该初给信号后，启动所述驱动机构(42)而将预定的小剂量药物推送出去。以这样的方式，就可以清除出截留在药剂筒(40)中的空气。

Description

带有电子控制单元的笔型注射器
技术领域
本发明涉及对一种注射装置的改进方案，尤其是，本发明涉及对这样一种便携式注射装置的改进：其所配送的药剂量是可控的。
背景技术
患有糖尿病的人员通常要用到这种注射装置，他们利用该装置来给自身注射一定剂量的胰岛素或胰岛素类型的药物。但可以理解：这种注射装置也适于用来注射其它的药剂。
曾经有一段时间，是采用一次性注射器来完成此类用药的注射工作的；事先用单独的管瓿或其它容器对注射器进行装药，然后再注射出该装入剂量。但是，对于这样的设计，存在着很多困难。尤其是，这样的设计安排并不适于体质虚弱者。另外，与这种注射器有关的社会不良影响也使得它们在获得公众认可方面存在问题。
为了解决这些困难，现有技术中已研发出多种所谓的笔型注射器。这些装置结构小巧，能被装入到夹克衣袋等物品中，并利用安装在注射器内的药筒或安瓿而可实现多级注射剂量。本发明的改进方案尤其适用于这样的笔型注射器。
发明内容
尽管这种笔型注射器相对于一次性皮下注射器有了相当大的改进，但仍然存在一些问题。本发明的一个优点在于：其能消除或至少是大体上减少了这些问题。本发明还改善了注射器的易使用性以及与用户的互动亲和性。
附图说明
下面将参照附图对本发明进行描述，但该描述仅是举例性质的，在附图中：
图1是一个俯视图，表示了根据本发明的笔型注射器；
图2是一个与图1类似的视图，图中所述注射器的端帽已被摘去；
图3是图1和2所示注射器的剖面图；以及
图3A是一个与图3类似的视图，图中注射器安装着一个已充药的药筒。
具体实施方式
首先参见图1到图3，图中表示了一种根据本发明的笔型注射器2。该注射器2包括一个主壳体4，在该主壳体上可拆卸地固定了一个端帽或端盖6。
在主壳体4的一第一端处设置有一控制面板区域8。该区域包括一显示板10、一第一剂量按钮12以及一第二剂量按钮14，其中的显示板通常是一块LCD(液晶)显示板，通过对第一、第二剂量按钮进行操作，可分别增大或减小要被泵送的药剂量。所示实施例中的控制面板区域10还包括一用于解除保险的按钮16。
在主壳体的第一端处还设置了一个配送按钮18。优选的设计为：当该配送按钮18未被摁压时，其与主壳体4是齐平的。
沿注射器2的纵向轴线，控制面板区域10的两侧制有多个沟槽或凹陷20。这些沟槽或凹陷便于使用者对注射器2的抓握。
在主壳体4的一第二端处，主壳体上可拆卸地固定了一个针头单元22。主壳体4的第二端上还设置了一个成型部分24。
在实际使用中，在造型部分24的后面，主壳体4中存放了一个装有药剂的筒体40或安瓿。作为优选措施，该成型部分最好是透明的，以便于用户能观察到其中的药筒40。
在主壳体4的第二端上设置有一个初给按钮26。可以理解：如果端帽6罩在主壳体的第二端上，则就不可能在无意中按下初给按钮26，同时人员也不可能被针头单元22扎到。还可在主壳体4的第二端上设置一合盖检测开关28，用于检测端帽或端盖6是否被盖合到位。
从图3中可看到与各个按钮对应的一初给触点30、一解除保险触点32、一第一剂量触点34以及一第二剂量触点36。图中还表示出了一个与配送按钮18相对应的配送触点19。
参见图3，从图中可看出，为电池或电池组等电源38留有适当的位置。还留出了一个适当的区域，用于在该区域内安装药剂筒40或安瓿。可通过将主壳体4的成型部分24设计成可拆卸的，而使该区域成为可接近的，从而可按照用户的需要更换药筒40或安瓿。
在主壳体4的一第三区域内设置了一套驱动机构42，该驱动机构42由电源38提供能量，并作用在药剂筒40或安瓿上。
药剂筒40或安瓿包括一容器44或套筒，其头部一端被一盖板46封闭，另一端则被一可移动的塞块48或堵头所密封。当安装就位之后，针头单元22就从盖板46中穿出去，塞块48向盖板的移动将会把药筒40或安瓿内的药剂推送出去。其中的药筒可以是符合ISO/FDIS 11608Part3标准的3ml药筒，或者是可与该注射器相配的其它任何合适的药筒。
塞块48或堵头受一活塞或柱塞50的作用而移动，其中的活塞或柱塞作为驱动机构42中的一个部件。活塞或柱塞50可在一个完全抽回的第一位置(图中未示出)与一个完全伸入的第二位置之间移动，在其中的第一位置上，能对药筒40或安瓿进行更换，而在第二位置上时，能将尽可能多的药剂从药筒40或安瓿中推送出去。可在主壳体4中设置一末端限位开关52，用于检测活塞50是否处于完全抽回位置。末端限位开关52的跳开将会使一个卡扣或其它的紧固装置释放，从而使主壳体4成为可接近的，进而能对药筒40进行更换。
驱动机构42是由一电动机54带动的，电动机54受一电子控制单元(图中未示出)的控制。电动机54应当是可反转的，以使得活塞50可在第一位置与第二位置之间移动。从图3可看出，电动机54是通过一齿轮传动系42对活塞50进行驱动的，利用一第三转子58的转动而促使活塞50相对于第三转子58移动。
优选的是，用户应能感觉到电动机54以及与其相关的驱动机构42的震动，和/或听到它们在工作时的声响。这样，能提高使用者在使用该注射器2时的把握感。
下面将对根据本发明的笔型注射器的功用进行描述，该描述尤其是参照图1、2和图3进行的。
注射器2中设置有一电子控制单元。该电子控制单元既与驱动机构相联接，也与用户界面相联接。所述用户界面包括显示板10和用户操作按钮(以及相应的触点)。电子控制单元是基于微处理器构建的。无论是易失性存储器、还是永久性存储器都可以用来存储“用药历史”信息和有关患者的特定信息。可以理解：通过对用户操作按钮进行按压将会向电子控制单元发送相应的信号，也就是说，当按压初给按钮26时，将会向电子控制单元发送一个初给信号。
电子控制单元优选地是由注射器电源38供电的。
注射器2最好还包括一个部件，用于使电子控制单元可与个人计算机等外部设备进行通讯。
注射器2还具有初给检测装备(例如一倾斜开关或加速度计)，用于判断注射器2是否处于倒置状态。一旦检测到注射器2处于倒置状态(针头朝上)之后，注射器2将自动转换到初给预备状态。通过对初给按钮26进行摁压可触动初给，从而启动一次小剂量的定量配送。当初给按钮26被按下时，电子控制单元可使一扬声器发声。
在其它时候，初给按钮26始终处于无效状态。当初给按钮26被激活时，控制面板区域上的其它按钮(即用来设定或分配剂量的那些按钮)就无效了。换言之，当初给按钮26处于激活状态时，电子控制单元或处理器将仅对驱动机构42实施控制，以此来触发一次小定量的配送。
当保险解除按钮16被持续摁压了足够长的时间之后，电子控制单元将使一扬声器发声，从而向用户提供音响反馈。
保险解除按钮16的作用是激活配送按钮18。优选的是，在注射器2变为解除保险状态之前，要按压住解除按钮、并保持预定的一段时间。另外，还可在显示板10上显示出保险已解除的情况。保险解除按钮最好是与顶盖检测开关28是联动的，从而，只有当顶盖6被摘去时，保险解除开关16才能发挥功用，从而才能解除注射器2的保险。
另外，在一优选实施例中，电子控制单元中的一个时钟将判断：在注射器2被解除保险之后的一指定时间间隔内，配送按钮18是否被按下。如果在该指定时间间隔内配送按钮18未被按下，则电子控制单元将把注射器2置于上保险状态。作为备选方案，如果在一预定时间段内，保险解除按钮被用户第二次按压，则注射器就将被禁用。
在一可选实施例中，配送按钮18既作为初给按钮也作为配送按钮。当通过将注射器2置于针头向上的位置而激活初给检测器时，配送按钮18的作用就将转换为上述实施例中的初给按钮。
优选的是：注射器2的各个按钮在本质上是触感性的，从而能向使用者反馈触觉感受。
显示板10一般是一LCD显示屏，其将显示出与装置工作有关的文字数字信息和图形信息。显示板10最好能指示出：选择的剂量、前一次的剂量以及从注射前一次药剂起已流逝过的时间。通常，从前一次注射算起已经经过的时间被限定在之前的48小时之内，但其它的时间限定也是可行的。
可被显示出的其它信息包括：
-注射器已被解除保险从而处于配送预备状态(图形信息)；
-注射器正在执行配送(图形形式)；
-注射器已经排送出选定剂量的药物，在将针头从身体上拔出之前，用户应当等待一段时间；
-等待时间已完毕；
-用药历史—通常是48小时内的历史，此信息被表达为用药剂量以及各次用药之间的时间间隔；
-药筒中剩余药剂的量，该药剂量优选地表示为药剂的剂量单位数目；
-装置是正处于初给位置(该信息显示可以是上文提到的音响提示信息的补充，也可以是取代音响的提示)；
-扬声器音量设定，例如高音量、低音量或静音；
-注射器处于其工作寿命的末期(例如是电池电量指示—图形信息，或表示为达到产品预期工作寿命的使用天数或完整工作循环次数的倒计数—文字数字信息)；
-针头可能发生了堵塞；
-正处于更换药筒40的过程中；
-选定的剂量是药筒40中所容纳的最大容量；
-可获得的最大药剂量小于所需剂量。
出于市场营销的要求和/或根据用户的需要，显示板10可为用户提供一个菜单语言选项。所显示的文字可包括上文提到的信息和/或其它的信息。该语言选项可以是预编程设定的，或者是由用户进行选择的。优选的是：可通过设置在显示板10上的菜单对语言选项进行选择。
可在显示板上以易于阅读的大字体清楚地同时显示出这些信息：当前选定的剂量值、前次注射采用的剂量值以及从前次用药算起的时间(以小时为单位)。优选的是，显示板中还设置有背光源。
显示板10最好对正在被配送出去的选定剂量有一个图形指示。例如可通过一动画图形或一倒计数(或者是这两者的结合)来实现该信息指示。
控制按钮具有多项功能。剂量按钮12、14使用户能选择所需的剂量。用药保险解除按钮16使用户能确认所选定的所需剂量。第一剂量按钮可将剂量水平进行递增，而第二剂量按钮则用于递减剂量水平。可通过将剂量调节按钮12、14按下(并保持一小段时间，例如1-2秒)来将剂量值重置为零。然后，使用者可按照单步长(半步长)的形式来进行调高(或调低)。
剂量调节按钮12、14被设计成每按压一次就使选定的剂量值增加或减小一个(或半个)步长值。在一备选实施例中，按压其中某个按钮、并保持该按压状态将会使剂量值开始滚屏(向上滚屏或向下滚屏)，以便于更加快速地改变剂量范围。
用户可利用配送按钮18来启动药剂的配送。初给按钮26可将一个单位的药剂从药筒40中配送出去。因而，如果在注射器2中蓄留有任何的空气，都可以利用该初给按钮26推送出去。还设置了一个开门卡扣，以便于接近主壳体中的药筒40。

Claims (4)

1.一种注射装置，这种注射装置具有一主壳体(4)，该主壳体包括一驱动机构(42)，用于选择性地将一定剂量的药剂从一药剂筒(40)中、经一针头单元(22)推送出去；并包括一电子控制单元，用于对驱动机构(42)进行控制，其特征在于：所述注射装置还包括一初给按钮(26)，其能向电子控制单元发送一初给信号，电子控制单元在接收到该初给信号后，启动所述驱动机构(42)而将预定的小剂量药物推送出去。
2.根据权利要求1所述的注射装置，其特征在于：注射装置还包括一顶盖(6)，其适于罩封住针头单元(22)和主壳体(4)的一部分；初给按钮(26)设置在主壳体(4)的部位内适于被所述顶盖遮盖住。
3.根据权利要求1或2所述的注射装置，其特征在于：注射装置还包括一初给检测装置，用于检测注射装置所处的定向位置；当注射装置处于预定的定向时，电子控制单元将只对初给信号作出响应以促使驱动机构工作。
4.根据权利要求3所述的注射装置，其特征在于：注射装置还包括多个按钮(12、14、18)，这些按钮在使用中可产生出其它的信号，电子控制单元可对这些信号产生响应，当注射装置处于预定的定向位置时，电子控制单元不对所述的其它信号作出响应。
CNB018211402A 2000-12-22 2001-12-21 带有电子控制单元的笔型注射器 Expired - Lifetime CN1290589C (zh)

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CNB01821083XA Expired - Lifetime CN1267161C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔式注射器
CNB018210546A Expired - Lifetime CN1270786C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔式注射器
CNB018210953A Expired - Lifetime CN1290588C (zh) 2000-12-22 2001-12-21 具有药剂筒夹持机构的笔型注射器
CNB018210570A Expired - Lifetime CN1284609C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔型注射器
CNB018211666A Expired - Lifetime CN1292807C (zh) 2000-12-22 2001-12-21 用于注射装置的驱动机构
CNB018210589A Expired - Lifetime CN100400117C (zh) 2000-12-22 2001-12-21 用于注射设备的药剂计量器
CNB018210805A Expired - Lifetime CN1248746C (zh) 2000-12-22 2001-12-21 用于注射装置的驱动机构
CNB018210937A Expired - Lifetime CN1292809C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔型注射器
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CNB018210953A Expired - Lifetime CN1290588C (zh) 2000-12-22 2001-12-21 具有药剂筒夹持机构的笔型注射器
CNB018210570A Expired - Lifetime CN1284609C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔型注射器
CNB018211666A Expired - Lifetime CN1292807C (zh) 2000-12-22 2001-12-21 用于注射装置的驱动机构
CNB018210589A Expired - Lifetime CN100400117C (zh) 2000-12-22 2001-12-21 用于注射设备的药剂计量器
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CNB018210937A Expired - Lifetime CN1292809C (zh) 2000-12-22 2001-12-21 具有电子控制单元的笔型注射器
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CNA01821164XA Pending CN1482933A (zh) 2000-12-22 2001-12-21 带有电子控制单元的笔型注射器
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CN1290588C (zh) 2006-12-20
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DE60110642T2 (de) 2006-01-19
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MXPA03005593A (es) 2004-05-17
JP2004516109A (ja) 2004-06-03
DE60110642D1 (de) 2005-06-09
CN100400117C (zh) 2008-07-09
MXPA03005589A (es) 2004-05-14
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ES2240341T3 (es) 2005-10-16
CY1106295T1 (el) 2011-10-12
BR0116274A (pt) 2003-12-30
KR20040023580A (ko) 2004-03-18
DE60127303T3 (de) 2018-08-16
DE60110637T2 (de) 2006-01-19
DE60110463D1 (de) 2005-06-02
KR100826222B1 (ko) 2008-04-30
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JP2004516107A (ja) 2004-06-03
MXPA03005584A (es) 2004-05-17
WO2002051477A1 (en) 2002-07-04
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PT1349591E (pt) 2005-11-30
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