CN1292809C - 具有电子控制单元的笔型注射器 - Google Patents
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- 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
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- 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
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- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
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- 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
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- 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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
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- 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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- A—HUMAN NECESSITIES
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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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- 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
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- A61M5/31545—Setting modes for dosing
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- Y10S128/00—Surgery
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Abstract
本发明公开了一种注射设备,用于从药剂筒注射药剂,药剂筒(40)具有在药剂筒(40)内可替换的塞子(48)以便使药剂从药剂筒(40)中排出。注射设备包括驱动装置(42)以及电子控制单元,驱动装置(42)用于有选择地作用于塞子(48)以便施用药剂筒(40)中的药剂,电子控制单元用于控制驱动装置(42)的操作。在电子控制单元的控制下,驱动装置(42)最初以第一速度作用,此后以第二速度作用。
Description
技术领域
本发明涉及注射设备的改进,特别是用于施与(dispense)可控药剂量的便携式注射设备中的改进。
背景技术
通常,这些注射设备由患糖尿病的那些人使用来将胰岛素或胰岛素型药剂的剂量施与他们自己。将理解这些注射设备适合于注射其它药剂。
曾经,通过使用一次性注射器来施用这些剂量;首先用单独的药瓶或其它容器装满注射器,然后用来注入剂量。然而,在这种装置中有许多困难。具体来说,这种装置不适用于老人。其次,与这些注射器有关的社会特征使它们的公众使用成问题。
发明内容
为克服这些问题,已经开发了多种所谓的笔型注射器。这些装置很小,能装在夹克衣袋等等中并允许从包含在注射器中的药筒或安瓿中获得多种剂量。本发明特别适用于这种笔型注射器。
根据本发明,提供了一种笔型注射设备,用于从药剂筒注射药剂,药剂筒具有在药剂筒内可替换的塞子以便使药剂从药剂筒中排出,注射设备包括驱动装置以及电子控制单元,驱动装置用于有选择地作用于塞子以便施用药剂筒中的药剂,电子控制单元用于控制驱动装置的操作,其中在电子控制单元的控制下,驱动装置最初以第一速度作用,此后以第二速度作用,以及所述注射设备进一步包括检测施与阻力的装置,所述装置将施与阻力信号提供给电子控制单元,其中在电子控制单元接收到施与阻力信号后,在电子控制单元的控制下,驱动装置以第二速度起作用,所述第二速度慢于第一速度。
尽管这种笔型注射器被认为对一次性皮下注射器的改进,但问题仍然存在。本发明的优点在于它消除了,或至少基本降低了这种问题。本发明也提供用于提高使用方便以及提高与用户的交互作用。
附图说明
现在仅通过例子,参考附图来描述本发明,其中:
图1是根据本发明的笔型注射器的平面图;
图2表示类似于图1的具有省略注射器的笔帽的视图;
图3表示图1和图2的注射器的截面图;以及
图3A表示与图3类似在注射器中具有装满的药筒的视图。
具体实施方式
首先,参考图1-3,可以看出根据本发明的笔型注射器2。注射器2包括主外壳4,易松开地固定到笔帽或盖6。
在主外壳4的第一端,提供控制面板区8。该区包括显示面板110,通常为LCD显示器,以及第一剂量按钮12以及第二剂量按钮14,可操作第一和第二剂量按钮来增加或减少将输送的药剂的剂量。在所述实施例中的控制面板区10还包括准备(arm)按钮16。
在主外壳的第一端,还提供施与按钮18。
优选地,当不按压时,施与按钮18与主外壳4齐平。
沿注射器2的纵向轴,在控制面板区10的每个边提供多个凹槽或凹口20。这些有助于用户握紧注射器2。
在主外壳4的第二端,易松开地将针单元22固定到主外壳。在主外壳4的第二端还提供成形部分24。
使用中的药剂的药筒40或安瓿容纳在成形部分24后的外壳4中。优选地,成形部分是透明的以便可允许用户看见药筒40。
同时在外壳4的第二端上提供启动按钮26。将理解到当笔帽6放在外壳的第二端的适当位置上时,将不可能不经意地按压启动按钮26或被针单元22所刺。在主外壳4的第二端上还可包括盖检测开关28以便检测笔帽或盖6是否在原位。
在图3中,可以看到与各个按钮对应的启动触点30、准备触点32、第一剂量触点34以及第二剂量触点36。也示出了与施与按钮18对应的施与触点19。
现在参考图3,可看出为电源38诸如电池或电池组提供适当的位置。也存在放置药剂的药筒40或安瓿的适当的区域。该区域可通过移动主外壳4的成形部分24来接触以允许用户根据需要替换药筒40或安瓿。
在主外壳4的第三区域中,提供由电源38操作并作用于药剂的药筒40或安瓿的驱动装置42。
药筒40或安瓿包括在一端由在其首端的盖46封闭,另一端由可移动塞子48或制动器密封的容器44或套。当处于原位时,针单元22戳穿盖46并且塞子48向盖46移动将导致排出包含在药筒40或安瓿中的药剂。根据ISO/FDIS 11608部分3,药筒可为3ml药筒或适合于注射器的任何其他适合的药筒。
通过形成部分驱动装置42的活塞或柱塞50的运动引起塞子48或制动器的运动。活塞或柱塞50可在第一全抽出位置(未示出)和第二全伸出部分间移动,第一全抽出位置允许替换药筒40或安瓿,在第二全伸出部分,已经从药筒40或安瓿排出尽可能多的药剂。在主外壳4中提供止端开关52以便检测活塞50是否处于全抽出位置。松开止端开关52将松开钩子或其它紧固装置以便允许进入主外壳4来替换药筒40。
在电子控制单元(未示出)的控制下,由马达54来操作驱动装置42。马达54应当是可逆的以便允许在第一和第二位置间移动活塞50。在图3中,可以看出马达54通过齿轮组42来驱动活塞50,以便第三转子58的旋转使得活塞50相对于第三转子58移动。
优选地,在操作中,用户能感觉到马达54和相关驱动装置42的振动和/或听到它们。用这种方式,在实际操作注射器2中增加了用户的置信度。
现在将具体参考图1,2和3,描述根据本发明的笔型注射器的功能。
注射器2具有电子控制单元。电子控制单元与驱动装置和用户接口连接。用户接口包括显示面板10和用户可操作按钮(以及相关触点)。电子控制单元是基于微处理器的。可使用易失或非易失存储器来存储“剂量历史”以及病人的具体信息。
优选地,由注射器电源38向电子控制单元供电。
优选地,注射器2还包括用于电子控制单元和外部装置诸如个人计算机间通信的端口。
注射器2还具有启动检测设备,(诸如倾斜开关或加速计)以便识别何时颠倒注射器2。在检测到反向位置(针向上)后,注射器2将自动改变到准备启动的状态。可通过按压启动按钮26来初始化启动以产生固定的小施与动作。当按压启动按钮26时,电子控制单元可使扬声器发声。
在所有其他时间,启动按钮26无效。当启动按钮26有效时,控制面板区中用于设置或施与剂量的所有其他按钮无效。
当在足够的时间周期后按压准备按钮16时,电子控制单元使扬声器发声以便向用户提供声反馈。
准备按钮16的功能是使施与按钮18有效。在注射器2变成待命前,优选地压下准备按钮预定时间周期。另外可将待命状态显示在显示面板10上。优选地,将准备按钮的功能与盖检测开关28相连以便当不存在盖6时,准备按钮16将仅起使注射器2待命的作用。
另外,在优选实施例中,电子控制单元中的时钟将检测在注射器2待命后,在规定时间间隔内是否已经按压施与按钮18。如果在规定时间间隔内还没有按压施与按钮18,那么电子控制单元将解除注射器2。
另外,如果在预定时间间隔内,用户第二次按压准备按钮,那么将禁用注射器。
在另一实施例中,剂量按钮18起启动按钮和剂量按钮的作用。当由针向上的注射器2起动启动检测器时,施与按钮18将改变为在前实施例中的启动按钮的功能。
优选地,注射器2的按钮实际上是可触摸的以便向用户提供感觉反馈。
显示面板10通常为LCD显示器并且将提供与设备的操作有关的字母数字和图形信息。显示面板10优选地表示选择的剂量、在前剂量以及从施用在前剂量以来的时间。通常,从在前剂量以来的时间限定到在前48小时内的时间周期,不过其他时间周期是可能的。
可显示的另外的信息包括:
-注射器待命并准备施与(图形)
-注射器正施与(图形)
-注射器已经施与选定的剂量并且在将针从用户的身体移出之前,用户应当等待
-等待周期已过
-根据所采用的剂量以及剂量间的耗费时间的剂量历史,特别是过去48小时的剂量历史
-药筒中剩余的药剂量,优选地是按药剂的剂量单位
-设备处于启动位置(除上述提到的声表示之外或代替上述提到的声表示)
-扬声器音量设置,例如,高、低或静音。
-注射器正濒临其寿命终点(例如,电池能量级表示-根据到预定产品寿命期限-字母数字的天数或整个操作周期的图形或递减计数)。
-针可能受阻
-正进行替换药筒40
-选择的剂量是可用于药筒40的最大量
-可用最大剂量小于所期望的剂量。
为适合于市场和/或用户,显示面板10可向用户提供语言选项的选择。所显示的文本可包括上述提到的和/或另外的信息。语言选项可由用户预先编程或选择。优选地,用户可通过在显示面板10上提供的菜单选择语言选项。
当前选定的剂量值、在前使用的剂量值以及从施与在前剂量以来的时间(按小时)均可几乎同时在显示器上以大的、易读的字符示出。优选地,显示器具有背光。
优选地,显示器10提供正施与的选定剂量的图形表示。这可通过例如,按动画或递减计数(或二者的结合)来实现。
控制按钮具有多个功能。剂量按钮12、14允许用户选择所需剂量。剂量准备按钮16允许用户确认选择的所需剂量。该第一剂量按钮可递增剂量级以及第二剂量按钮可递减剂量级。可按下(并保持短时间,1-2秒)剂量标度按钮12、14来重新将剂量值设定为0。然后用户可按单个(或半个)增量上调(或下调)。
规定按一次剂量标度按钮12、14单个(或半个)增量选定的剂量值。在另一实施例中,按压并保持一个按钮将使剂量值开始向上滚动(或向下滚动)以便更快速地选择剂量。
施与按钮18允许用户开始施与剂量。启动按钮26从药筒40施与剂量单位。因此,如果注射器2中收集有任何空气,这可通过使用启动按钮26排出。提供门闩扣以便允许进入药筒40。
注射器2也可具有声音报警,诸如压电发声器或电可操作的发声器。设备可具有设置发声器的音量级和/或关闭发声器的开关或装置。这可用来提供一个或多个按钮的按压的声音确认,作为警告用户在药筒40中有有限的药剂量的报警指示器,作为警告用户注射器正濒临其寿命终点(电池消耗指示器)的报警指示器来表示已经输送完所需剂量并且从完成施与操作以来已过去预定时间,因此用户现在可自由地根据需要取出针和/或其他条件。除在显示面板10上提供可视信号以及除通过按钮的触觉特性提供的任何反馈外,可提供声音信号。
由于药筒40为标准大小,将通过由驱动装置驱动的柱塞的相同的行程来耗尽每个药筒40。只要柱塞50处于全伸出位置,则已知药筒为空并将向用户提供该表示。
当操作用于将移出的耗尽的药筒40的门闩扣时,操作驱动装置42以便反转丝杠60来取出活塞50直到丝杠60到达在已知的参考点上提供的止端开关52。
当检测到新药筒40时,例如,通过触点开关(未示出),以及关闭的门闩扣,电子控制单元推进丝杆60直到活塞50到达药筒塞48。这可方便地通过将诸如圆顶触点开关的微开关51安装到活塞50的自由端来实现。
由于活塞48的准确位置可参考后止端52来计算,因此可确定容纳在药筒40中的多个药剂单位。因此通过本发明的注射器2,可使用半空或不正确填充的药筒40。优选地,具有确定容纳在药筒中的多个单位的电子控制单元将不允许大于为施与将上调的剩余的剂量。
另外,作为电子控制单元部分的用户接口软件可帮助用户通过药筒转换开关分离所需的剂量。例如,如果用户由于采用三十单位剂量,但注射器中只剩下二十个单位,那么用户能施与二十个单位,替换药筒40以及注射器2将自动向用户提供十个单位,作为第一剂量的“未决余额”。如果用户规定时间内接受“未决余额”(或其他剂量大小),那么注射器2将回复到正常显示状态。在这种情况下,注射器历史可将“分离剂量”记录为单个剂量(为分离剂量的总和),只要在规定时间内接受这些剂量。另外,用户可选择接受剂量的第一部分,然后取消第二部分的剂量而不是依赖于上述的超时特征。该动作将记录为注射器历史信息的一部分。
也可提供“剂量中断”功能,为此,用户可停止(或恢复)施与动作。如果注射很疼或如果用户希望选择大剂量,但意欲在他的/她的身体的两个地方间输送分离的剂量。在第一实施例中,按下剂量按钮来开始,再按停止,再按重新开始等等。另外,可按压并保持剂量按钮向下来施与,然后释放来停止,然后压下并保持向下来重新开始。
优选地,驱动装置42在施与期间以恒定速度操作。然而,在每个新药筒40开始时,较慢速度可适合于增加可用于克服药筒40中的塞子48的静摩擦的压力。另外,可控制施与速度来适于用户放松。
另外,驱动装置能以可变速度操作。在这种情况下,注射器2将用来检测施与的阻力,例如,如果药剂,例如,胰岛素很凉,它可变得很粘,因此为施与提供更大的阻力。如果这对有效施与操作来说无影响的话,那么驱动装置可减缓来输送更多的输出压力,然后停止。换句话说,如果,例如,施与的阻力是因为注射器中的药剂问题,那么电子控制单元将关闭驱动装置,因此不施与,而不是寻求施与另外的药剂。
由于使用电气机械驱动,可由操作开关的用户启动施与动作。这意味着操作施与按钮所需的压力可为了用户的舒服和人体工程学要求优化。
驱动装置42可另外包括1位编码器(例如,安装在齿轮组56中的第一级上的电感传感器)来检测马达的滑动。因此,只要驱动装置42被卡住,这能被检测,电子控制单元能暂停驱动装置42并向用户表示发生了错误。
Claims (6)
1、一种笔型注射设备,用于从药剂筒注射药剂,药剂筒(40)具有在药剂筒(40)内可替换的塞子(48)以便使药剂从药剂筒(40)中排出,注射设备包括驱动装置(42)以及电子控制单元,驱动装置(42)用于有选择地作用于塞子(48)以便施用药剂筒(40)中的药剂,电子控制单元用于控制驱动装置(42)的操作,其中在电子控制单元的控制下,驱动装置(42)最初以第一速度作用,此后以第二速度作用,以及所述注射设备进一步包括检测施与阻力的装置,所述装置将施与阻力信号提供给电子控制单元,其中在电子控制单元接收到施与阻力信号后,在电子控制单元的控制下,驱动装置(42)以第二速度起作用,所述第二速度慢于第一速度。
2、如权利要求1所述的注射设备,其特征在于,第二速度受注射设备的用户控制。
3、如权利要求1所述的注射设备,其特征在于,在驱动装置(42)以第二速度作用后,当施与阻力信号持续预定时间时,电子控制单元暂停驱动装置(42)。
4、一种从如权利要求1所述的注射设备内的药剂筒施与药剂剂量的方法,所述方法包括步骤:
使驱动装置(42)以第一速度作用于塞子(48);以及
此后使驱动装置(42)以第二速度作用于塞子(48)。
5、如权利要求4所述的方法,其特征在于,第二速度由注射设备的用户控制。
6、如权利要求4所述的方法,其特征在于,第一速度快于第二速度。
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GBGB0031466.6A GB0031466D0 (en) | 2000-12-22 | 2000-12-22 | Improvements in and relating to an injection device |
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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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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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2003
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2004
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2006
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2007
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2008
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2009
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2010
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