CN1482933A - 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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CN1482933A
CN1482933A CNA01821164XA CN01821164A CN1482933A CN 1482933 A CN1482933 A CN 1482933A CN A01821164X A CNA01821164X A CN A01821164XA CN 01821164 A CN01821164 A CN 01821164A CN 1482933 A CN1482933 A CN 1482933A
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control unit
electronic control
syringe
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injection device
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克里斯托弗·N·兰利
A
沙恩·A·戴
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罗伯特·F·维齐
罗伯特·伍斯顿
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    • 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
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
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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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
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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
    • A61M5/145—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
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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
    • 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
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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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/01—Motorized syringe

Abstract

本发明公开了一种用于对来自于药剂筒(40)的药物进行注射的注射装置。该注射装置包括：一驱动机构(42)，其包括一电动机(54)，用于对来自于药剂筒(40)的药剂选择性地进行配送；一用于对驱动机构的工作进行控制的电子控制单元；以及一用于对电动机的滑差率进行检测的检测器。当检测到电动机(54)发生运转打滑时，电子控制单元将暂停驱动机构(42)的工作。

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，是使用一次性注射器来完成此类用药的注射工作的；首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药量。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，并可利用安装在注射器内的药筒或安瓿而实现多级注射剂量。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其对用户的人机亲和性。
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，表示了一个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，图中注射器安装了一个已装药的药筒。
具体实施方式
首先参见图1到图3，图中表示了一个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。该区域内包括一显示板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的第二端处还设置了一个成型部分24。
在进行使用时，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：当端帽6盖合在主壳体的第二端上时，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的第二端上设置一盖合检测开关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相对应的一初给触点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留有一个适当的位置。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，由此能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所封闭，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会从盖板46中穿过去，塞块48向盖板46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 11608 Part3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的跳开将会释放一个锁扣或其它的紧固装置，从而使主壳体4成为可被开启的，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，从而一第三转轮58的转动将促使活塞50相对于该第三转轮58移动。
优选的是，用户应能感觉到电动机54以及与此相关的驱动机构42的震动，和/或听到它们在工作时的声响。这样，能提高使用者在判断注射器2是否正在工作时的可信度。
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”和有关患者的特定信息。
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还具有一初给检测装备(例如一倾斜开关或过载传感器)，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(针头朝上状态)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进行摁压可触发一次初始给药，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。
在所有其它时候，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就无效了，其中的其它按钮也就是指用来设定或配送剂量的那些按钮。
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状况。保险解除按钮最好与顶盖检测开关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，用户第二次按压保险解除按钮，则注射器就将被禁用。
在一备选实施例中，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，其显示出与注射装置工作状况有关的文字数字信息和图形信息。显示板10最好能指示出：所选择的剂量、前次注射的剂量以及从注射上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为在前的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。还设置了一个开门锁扣，以便于接近主壳体中的药筒40。
由于药筒40的尺寸规格是标准的，所以，柱塞受驱动机构作用而产生的同一行程将能排空各种药筒40。一旦柱塞50处于完全伸入位置之后，就可知药筒40已被排空，此时将向使用者发送一个有关此情况的指示信号。
当对开门锁扣进行操作、以便于将排空后的药筒40取出时，使驱动机构42工作，从而使一丝杠60反转，以此来将柱塞50抽回，直到丝杠60撞到设置在一已知参考位置处的末端限位开关52为止。
如果检测到新装入了一个药筒40、且开门锁扣已被闭合，则电子控制单元就将促使丝杠60向前进给，直到使柱塞50顶撞到药筒中的塞块48为止，其中，例如是利用一接触开关(图中未示出)来对新药筒进行检测的。可通过安装一微型开关51而方便地完成上述的工作，该微型开关例如是安装到柱塞50自由端上的一个半球状触点开关。
由于能精确地计算出塞块48相对于后端限位止挡52的确切位置，所以可确定出药筒40中药剂的计量单位数。因而，本发明的注射器2可使用半空的药筒40或装药量不规范的药筒40。优选的设计是：电子控制单元在已确定出药筒内所储存药物的计量单位数的情况下，将不允许需配送药量被调节到大于药筒中的剩余药量。
优选的是：驱动机构42在执行配送的过程中，其工作速度是恒定的。但是，在刚开始对新药筒40执行推送时，应适当降低速度，以增大所能产生的推动力，从而能克服塞块48在药筒40中的静摩擦阻力。作为备选方案，送药速度可以是可控的，以便于与用户的舒适度相适配。
另外，驱动机构还可以变速运转。在这样的情况下，注射器2将适于对送药阻力进行检测，例如，当药物—即胰岛素由于受冷而使粘度增大时，就会产生更大的送药阻力。此时，驱动机构的速度就会降低，以输出更大的作用力，而如果在执行了有效的配送动作后未产生任何效果，则停止驱动机构的工作。换言之，例如送药阻力是来自于注射器中的机械故障，则电子控制单元就会关掉以断开驱动机构，这样，就停止执行送药，而不是试图推送出更多的药物。
由于采用了机械—电子式的驱动方式，所以用户通过对一开关进行操作就可启动配送工作。这就意味着可对操作配送按钮所需的作用力进行优化设计，以使用户感到舒适，并符合人机工程学的要求。
另外，驱动机构42还可包括一个1比特位的编码器(例如是安装在齿轮系56第一传动级上的一个感应式变换器)，用于检测电动机的滑差率。这样，一旦驱动机构42被卡住时，电子控制单元就能检测到该故障，从而其可暂停驱动机构42的工作，并向用户发出指示发生故障的信号。

Claims (4)

1.一种注射装置，用于对来自于一药剂筒(40)的药物进行注射，该注射装置包括：一驱动机构(42)，其包括一电动机(54)，用于对来自于药剂筒(40)的药剂选择性地进行配送；一用于对驱动机构的工作进行控制的电子控制单元；以及一检测器，用于对电动机的滑差率进行检测，其中，当检测到电动机(54)发生运转打滑时，电子控制单元将暂停驱动机构(42)的工作。
2.根据权利要求1所述的注射装置，其特征在于：所述检测器是由一个一位编码器构成的。
3.根据权利要求2所述的注射装置，其特征在于：驱动机构(42)还包括一齿轮系(56)，所述编码器是由一个安装在齿轮系(56)第一传动级上的导电变换器构成的。
4.根据权利要求1到3之一所述的注射装置，其特征在于：注射装置还包括一显示板(10)，当所述检测器探测到电动机(54)发生打滑时，电子控制单元促使显示板(10)显示出发生故障的指示信号。
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HK1059747A1 (en) 2004-07-16
KR100788316B1 (ko) 2007-12-27
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JP2004516107A (ja) 2004-06-03
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DE60110929T2 (de) 2006-04-27
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DE60110639D1 (de) 2005-06-09
BR0116276A (pt) 2003-12-30
JP2004516111A (ja) 2004-06-03
EP1353712A1 (en) 2003-10-22
JP4150589B2 (ja) 2008-09-17
BR0116277A (pt) 2003-12-30
MXPA03005590A (es) 2004-05-14
JP5054739B2 (ja) 2012-10-24
JP2004521681A (ja) 2004-07-22
BR0116280B1 (pt) 2009-12-01
DE60110636T2 (de) 2006-01-19
IL156239A0 (en) 2004-01-04
ATE294601T1 (de) 2005-05-15
DE60112326D1 (de) 2005-09-01
BR0116296A (pt) 2004-08-17
US20040024364A1 (en) 2004-02-05
DE60112472T2 (de) 2006-08-17

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