CN1270786C - 具有电子控制单元的笔式注射器 - Google Patents

具有电子控制单元的笔式注射器 Download PDF

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CN1270786C
CN1270786C CNB018210546A CN01821054A CN1270786C CN 1270786 C CN1270786 C CN 1270786C CN B018210546 A CNB018210546 A CN B018210546A CN 01821054 A CN01821054 A CN 01821054A CN 1270786 C CN1270786 C CN 1270786C
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dosage
user
cartridge case
syringe
control unit
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克里斯托弗·N·朗格利
肖恩·A.·戴
罗伯特·F.·维西
罗伯特·沃尔斯通
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Sanofi Aventis Deutschland GmbH
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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
    • A61M5/14—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
    • 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
    • A61M5/24—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
    • 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
    • A61M5/1452—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
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    • 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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    • 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
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/21—General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
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    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
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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
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    • 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

公开一种注射器，用于从第一药筒(40)注射药物。所述注射器包括：驱动机构(42)，用于选择性地从第一药筒(40)释放药物；剂量调节机构(12、14)，通过其用户可以确定所需的将要释放的药物剂量；电子控制单元，用于响应剂量调节机构(12、14)，控制驱动机构(42)的操作；以及显示面板(10)。当在第一药筒(40)中剩余不足量的药物以满足释放所需的剂量时，可以根据用户的判断释放该不足量的药物，电子控制单元存储与所需剂量和该不足量药物之间的差值相对应的值，将该值在显示面板(10)上展现给用户，作为在用替换药筒替换第一药筒(40)之后要从替换药筒中释放的第一药物量。

Description

具有电子控制单元的笔式注射器
本发明涉及注射器的改进，特别涉及用于释放可控药物量的便携式注射器的改进。
典型地，这些注射器由糖尿病患者用来给自己注射一定剂量的胰岛素或胰岛素型药品。应该理解，这些注射器也适于注射其他药品。
曾经，这些剂量是使用一次性注射器来注射的；该注射器首先从分开的药瓶或其他容器充满，然后用来注射该剂量。然而，使用这种方式存在很多困难。特别是这种方式不适于体弱者。至于其他方面，与这种注射器相关的社会污染也使得它们的广泛使用成为问题。
为克服这些困难，很多所谓的笔式注射器已被开发出来。这些注射器体积小，从而能够放在口袋等中携带，并且允许从贮放在注射器内的药筒或安瓿获得各种剂量。本发明就是这种笔式注射器的特定应用。
虽然这些笔式注射器是对一次性皮下注射器的相当大的改进，但是仍然存在一些问题。本发明的一个优点是它消除或者至少充分减轻这些问题。本发明还改进其易用性和改进其与用户的交互性。
现在将参照附图仅作为示例对本发明进行描述，其中：
图1是本发明的笔式注射器的平面图；
图2类似于图1，其中，注射器的端盖被摘掉；
图3是图1和2的注射器的截面图；以及
图3A类似于图3，其中，注射器的药筒处于充满状态。
首先参照图1到3，可以看到本发明的笔式注射器2。笔式注射器2包括主壳体4，其中，端盖或封盖6活动地套在主壳体4上。
主壳体4的第一端安设有控制面板区域8。该区域包括显示面板10，典型地为LCD显示器，以及第一剂量按钮12和第二剂量按钮14。第一和第二剂量按钮用来增加或减少所要输送的药物剂量。所示实施例的控制面板区域8还包括预备按钮(arm button)16。
主壳体的第一端还安设有释放(dispense)按钮18。最好，当不按下时，释放按钮18与主壳体4齐平。
沿着注射器2的纵向轴，控制面板区域8的两侧均安设有很多凹槽或凸槽20，它们帮助用户握稳注射器2。
在主壳体4的第二端，针头单元22可松开地固定到主壳体上。主壳体4的第二端还安设有定型(shaped)部分24。
使用时，药筒40或药物安瓿存储在定型部分24后面的壳体4中。最好，定型部分是透明的，从而用户可以看到药筒40。
起动(primer)按钮26也安设在壳体4的第二端上。可以理解，当端盖6套在壳体的第二端上时，无意地按下起动按钮26或被针头单元22刺伤将是不可能的。在主壳体4的第二端，还可以包括封盖检测开关28，以检测是否套有端盖或封盖6。
在图3中，可以看到对应于各个按钮的起动触点30、预备触点(arm contact)32、第一剂量触点34和第二剂量触点36。图中还示出对应于释放按钮18的释放触点19。
参照图3，可以看到电源38如单节电池或多节电池安设在一个适当的位置。还存在一个适当的区域用来安放药筒40或药物安瓿。该区域可以通过主壳体4的可移动定型部分24来接近以允许用户根据需要更换药筒40或安瓿。
在主壳体4的第三区域，安设有驱动机构42，它由电源38运行并且作用于药筒40或药物安瓿。
药筒40或安瓿包括容器44或套筒，它在一端由其头端的封盖46封闭，并且在另一端由可移动塞头(bung)48或挡塞(stopper)密封。当就位时，针头单元22刺穿封盖46，并且塞头48向封盖46的移动将使贮放在药筒40或安瓿内的药物排出。药筒可以是符合ISO/FDIS 11608部分3的3ml药筒或者适合注射器的任何其他适当药筒。
塞头48或挡塞的移动是由形成驱动机构42的一部分的活塞或柱塞50的移动导致的。活塞或柱塞50可以在允许更换药筒40或安瓿的第一完全回缩位置(未示出)与从药筒40或安瓿排出尽可能多药物的第二完全伸出位置之间移动。终点挡板开关52可以安设在主壳体4中，以检测活塞50处于完全回缩位置的时候。终点挡板开关52的脱扣可以松开闩锁或其他固定装置，从而允许访问主壳体4以更换药筒40。
驱动机构42在电子控制单元(未示出)的控制下由电机54操作。电机54应是可反转的，从而允许活塞50在第一和第二位置之间移动。在图3中，可以看到，电机54通过齿轮组42驱动活塞50，从而第三转子58的旋转使活塞50与第三转子58关联移动。
最好，用户可以觉察电机54及相关驱动机构42的振动并且/或者听到它们正在工作。这样，用户就可以从另一方面感知注射器2正在工作。
现在将具体参照图1、2和3描述本发明的笔式注射器的功能。
注射器2装备有电子控制单元。电子控制单元连接到驱动机构和用户接口。用户接口包括显示面板10以及用户可操作按钮(及相关触点)。电子控制单元是基于微处理器的。可以使用易失性或非易失性存储器来存储剂量历史’和病人特定信息。
电子控制单元最好从注射器电源38供电。
注射器2最好还包括一个通信端口，用于在电子控制单元与外部设备如个人计算机之间通信。
注射器2还具有起动检测装置(如倾斜开关或加速计)以识别注射器2倒置的时候。当检测到倒置位置(针头朝上)时，注射器2将自动改变状态，以准备起动。起动可以通过按下起动按钮26来发起以导致固定小量释放操作。当按下起动按钮26时，电子控制单元可以使扬声器发出声音。
起动按钮26在所有其他时候总是未激活的。当起动按钮26激活时，控制面板区域的所有其他按钮都是未激活的，也就是，用来设置或释放剂量的那些按钮。
当按下预备按钮16足够长的时间时，电子控制单元可以使扬声器发出声音，以向用户提供听觉反馈。
预备按钮16的功能是使剂量按钮18激活。最好，在注射器2进入待命状态之前，按住预备按钮预定时间。另外，可以将待命状态显示在显示面板10上。预备按钮的功能最好与封盖检测开关28相关联，从而仅当摘掉封盖6时，预备按钮16才起作用以使注射器2进入待命状态。
另外，在一个优选实施例中，电子控制单元内的时钟将检测在注射器2进入待命状态之后的指定时间间隔内是否按过剂量按钮18。如果在指定时间间隔内尚未按过剂量按钮18，则电子控制单元将解除注射器2的待命状态。可选地，如果用户在预定时间内第二次按下预备按钮，则注射器将禁用。
在一个可选实施例中，剂量按钮18可以既用作起动按钮，又用作剂量按钮。当起动检测器由于注射器2的针尖朝上而被激励时，剂量按钮18将改变功能为前面实施例中的起动按钮的功能。
注射器2的按钮最好具有可触知性，以向用户提供感觉反馈。
显示面板10典型地是LCD显示器，并且将提供与注射器操作相关的文字和图形信息。显示面板10最好指示所选用药剂量、前一用药剂量和前一用药后所过去的时间。典型地，前一用药后所过去的时间限于前48小时以内的时间段，但是其他时间段也是可能的。
可以显示的其他信息还包括：
-注射器处于待命状态和准备释放状态(图形)
-注射器正在释放(图形)
-注射器已释放所选剂量，并且在把针头从身体抽出之前用户应等待
-此等待时间已结束
-用药历史，典型地是最后48小时，按照所采用的剂量和用药之间的时间间隔
-药筒内的剩余药物量，最好按照药物的剂量单位
-注射器处于起动位置(补充或代替上述声音指示)
-扬声器音量设置为例如高、低或静音
-注射器的寿命将尽(例如，电池电量指示-图形，或者按照天数或完整工作循环倒计数到预定产品寿命期满-文字)
-针头可能被堵塞
-正在更换药筒40
-所选剂量为药筒40可获得的最大值
-可获得的最大剂量小于期望剂量。
显示面板10可以向用户提供适于市场和/或用户的语言选项的选择。所显示的文本可以包括上述和/或其他信息。语言选项可以由用户进行预编程或选择。用户最好可以通过在显示面板10上提供的菜单来选择语言选项。
当前所选剂量值、以前使用的剂量值以及释放前一剂量后所过去的时间(采用小时)可以用大且易读的字符全部同时清楚地显示在显示屏上。最好，显示屏还安设有背光。
显示面板10最好提供正在释放所选剂量的图形指示。这可以例如通过动画图形或倒计数(或两者的结合)来实现。
控制按钮具有多种功能。剂量按钮12、14让用户选择所需剂量。剂量预备按钮16让用户确认选择所需剂量。第一剂量按钮可以增加剂量级别而第二剂量按钮可以减小剂量级别。剂量调节按钮12、14可以按住(并保持一个短时间，1-2秒)来将剂量值复位到零。用户然后可以以单一(或一半)增量向上(或向下)调节。
剂量调节按钮12、14被规定为按一次的增量是单一(或一半)所选剂量值。在一个可选实施例中，按住并保持其中一个按钮将使剂量值开始(向上或向下)滚动，从而更快速地改变剂量大小。
释放按钮18让用户开始释放剂量。起动按钮26从药筒40释放一个剂量单位。因此，如果注射器2中搀入任何空气，则这可以使用起动按钮26来排出。提供开门闩锁是为了允许接近药筒40。
由于药筒40具有标准尺寸，因此各药筒40将通过驱动机构所驱动的柱塞的相同行程来排空。一旦柱塞50处于完全伸出位置，则药筒40被认为是空，并且将相应指示提供给用户。
当操作开门闩锁以移走空药筒40时，操作驱动机构42来倒退导杆60以回缩活塞50，直到导杆60碰到安设在已知基准点的终点挡板开关52。
当例如通过触点开关(未示出)检测到新药筒40，并且扣上开门闩锁时，电子控制单元推进导杆60，直到活塞50碰到药筒塞头48。这可以方便地通过将微开关51如汽包(dome)触点开关装配到柱塞50的自由端来完成。
由于塞头48的准确位置可以以后端挡板52为基准来计算，因此可以确定存储在药筒40内的药剂单位数。因此，半空或不正确充满的药筒40可以与本发明的注射器2一起使用。电子控制单元在确定存储在药筒内的单位数之后，最好不允许将释放剂量上调到大于剩余剂量。
另外，作为电子控制单元一部分的用户接口软件在更换药筒时可以帮助用户拆分所需的剂量。例如，如果用户应注射30单位剂量，但是在注射器2中仅剩余20单位，则用户可以注射该20单位，替换药筒40，然后注射器2将自动从第一剂量中提供给用户10单位作为“未用余量”。如果用户在规定时间内没有注射该“未用余量”(或其它剂量)，则注射器2将返回到正常显示状态。在这种情况下，注射器历史将记录“拆分剂量”作为单一剂量(拆分剂量的总量)，以便在规定时间内注射该剂量。或者，用户可以选择注射该剂量的第一部分并取消注射该剂量的第二部分，而不依赖于上述的超时特征。将该动作记录为注射器历史信息的一部分。
释放期间驱动机构42最好以恒速运行。但是，在每一个新药筒40的起始阶段，较低的速度可能更适于增加作用力，以便克服药筒40中塞头48的静摩擦。另外，可以控制释放速度以使用户舒适。
此外，驱动机构也可以变速运行。在这种情况下，注射器2将检测释放阻力，例如，如果药物，即胰岛素温度很低，其将变得更加粘滞，从而带来很大的释放阻力。那么，驱动机构可以变慢，以便输出更大的作用力，并且，如果没有效果将停止，直到有效的释放操作为止。换句话说，如果例如释放阻力是由于注射器的机械问题引起的，则电子控制单元将关闭驱动机构，不进行释放，从而不会进一步释放药物。
由于使用了电子机械驱动，所以释放操作通过用户操作一开关来启动。这意味着可以优化操作释放按钮所需的力，以便满足用户的舒适和人机控制要求。
驱动机构42还可以包括1比特编码器(例如，安设在齿轮组56第一级的感应换能器)，用于检测电机的滑动。由此，驱动机构42阻塞时，可以检测，从而电子控制单元可以暂停驱动机构42并向用户指示发生了错误。

Claims (4)

1.一种注射器，用于从第一药筒(40)注射药物，所述注射器包括：驱动机构(42)，用于选择性地从第一药筒(40)释放药物；剂量调节机构(12、14)，通过其用户可以确定所需的将要释放的药物剂量；电子控制单元，用于响应剂量调节机构(12、14)，控制驱动机构(42)的操作；以及显示面板(10)，其中，当在第一药筒(40)中剩余不足量的药物以满足释放所需的剂量时，可以根据用户的判断释放该不足量的药物，电子控制单元存储与所需剂量和该不足量药物之间的差值相对应的值，将该值在显示面板(10)上展现给用户，作为在用替换药筒替换第一药筒(40)之后要从替换药筒中释放的第一药物量。
2.如权利要求1所述的注射器，其特征在于，在用替换药筒替换第一药筒之后的预定时间内没有释放所述第一药物量时，电子控制单元复位，以允许用户接着操作剂量调节机构(12、14)来调节新的所需剂量。
3.如权利要求2所述的注射器，其特征在于，在所述预定时间内，用户可以复位电子控制单元，以允许用户操作剂量调节机构(12、14)来调节新的所需剂量。
4.如权利要求1所述的注射器，其中电子控制单元记录药物释放剂量的历史，其特征在于，在释放所述不足量药物后预定时间内释放所述第一药物量时，电子控制单元记录所述不足量和第一药物量的释放作为单一剂量。
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DK1349595T3 (da) 2005-11-21
EP1349591B2 (en) 2016-03-09
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