CN88102557A - 注射笔 - Google Patents
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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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- A61M5/315—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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- A61M5/178—Syringes
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- 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
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- Y10S128/01—Motorized syringe
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Abstract
适于携带在患者衣服上的注射笔包括一个腔室,腔室内有一个可变容积的注射液储液器或筒,一个泵杆,可相对储液器或筒移动位置以改变储液器容积;一个移动泵杆的驱动机构,该驱动机构包括一个电动马达,它由一个电子控制单元控制,控制单元包括一个记忆装置,用来存入和储液器储量对应的数据以及和向患者注射的注射液的单位数对应的数据,还包括把上述注射液单位数和储液器储量作比较并控制电动马达的比较器,控制单元最好是包括一个程序处理机的集成电路。
Description
本发明涉及一种注射笔,它包括一个容纳可变容积的注射液储液器或筒的腔室;一个泵杆可用来相对储液器移动,改变储液器的容积;一个用来移动泵杆的驱动机构。
这样的注射笔可在市场上买到,其商标为“NOVOPen”由在丹麦的NOVO工业公司提供。这种笔是研制用来在基本上每餐都需要胰岛素的状态时为糖尿病患者注射胰岛素的。在这样的状态中,对胰岛素的基本需要是由每天注射延时释放的胰岛素来满足。饭后所需的胰岛素是由饭前注射小量的短时效的胰岛素来满足的。这样的病人可以相对于进食的数量和时间改变需注射的胰岛素的剂量。而且这种灵活性因为下述因素而得到增加,即这种用作饭前注射的注射笔的大小适于放在衣服口袋中携带,例如放在一个夹克衣的口袋中,因此可以总在手边。
用这种NOVO笔,按一下按钮,就会使一个泵杆移动,接着又使一个活塞在注有胰岛素的筒中移动,这样就可注射少剂量胰岛素(2IE)。当按下这个按钮,使用者将听到两声卡 声,胰岛素注射完毕后,按钮回到初始位置,而泵杆以及活塞留在原位。
本发明的目的是提供一种前文所描述的那种类型的注射笔,在多脂肪的组织中注射胰岛素时,会产生高反压力,而这种注射笔能提供安全保护。本发明的另一个目的是使这种注射笔可以提供视觉信息,例如,有关胰岛素注入的进度。本发明还有一个目的是使这些注射笔对带事先没有装填好胰岛素的筒的笔也应适用,这也是本发明的一个目的。
按照本发明这种注射笔,可以为在多脂肪的组织中注射提供安全保护,其特征是驱动机构包括一个电动马达,因为有了这种电动马达,作用在泵杆上的力在驱动过程中大体上可以恒定保持在一个所希望的水平上,即使患者施加了过大的力(比一般所需要的大)也不会造成任何不希望的注射。
电动马达的施转运动可以通过一个齿轮和传动系统转变为泵杆的平移运动,这样推动活塞排出胰岛素液。
驱动机构的控制最好借助于一个电子控制单元,这个控制单元也和注射笔中成为一体,驱动和控制所需的动力由装在笔中的电池提供。
在以前公知的注射笔中不能获得的若干功能,使用这种带有电子控制单元的注射笔,都可以由使用者自己来完成。因为有了这种至少包括一个带有程序控制器的固定电路的控制单元,注射笔的尺寸大小也可以保持一定范围,因而其外观可保持笔的形状,这样使患者易于携带。
根据上面一段所述的内容,控制单元可以包括记忆装置,它的一部分最好作为第一剂量记忆装置,用来存入关于注射液的准确剂量数的数据。
为了使患者能在视觉上获得有关信息,例如所输送的胰岛素的进度,按照本发明的注射笔包括有一个显示器,至少由第一剂量记忆装置控制,显示器向使用者显示作为数据存入在第一剂量记忆装置中的上述的准确剂量数值。为了便于有视觉障碍的使用者使用,除显示器外,这种注射笔可以包括声调信号发生器,至少由第一剂量记忆装置控制。
为了设定需注射的剂量,注射笔可以包括一个剂量设定单元,它可以在外面操作,同时一个上/下计数电路装置和控制单元结为一体,控制单元响应于剂量设定单元输出的信号而改变储存在第一剂量记忆装置中的数据,直至与需要的剂量设定值所相应的数值。
通过患者操作剂量设定单元,贮存在第一剂量记忆装置中的数据可以依靠上/下记数电器装置调整到一个设定值。这个值对应于所需要的剂量。这个设定值在显示器中以剂量单位的形式显示或者以声调信号的形式从声调信号发生器里发出。
按照一个推荐实施例,注射笔设有一个测量单元,用来测量在储液器中的存液量。测量单元最好包括一个传感器,用来确定泵杆的位置,而且,控制单元可以包括一个下记数电路装置,它受来自测量单元的数据控制,用来减小存入第一剂量记忆装置中的数据。这样,输入的每一单位胰岛素都被记录下来,并通过和第一剂量记忆装置的联系,在显示器上显示出来,而且,如果可能的话,被声调信号发生器发出来。
而且,在记忆装置区域中,可以分配有储液器储量记忆装置,控制单元最好包括一个上/下记数电路装置,受来自测量单元的数据控制,它可以相应地改变存在储存器储量记忆装置中的数据。这样,用和第一剂量记忆装置同样的方式,存在储液器中储量记忆装置中的数据也和实际情况相适应。
控制单元包括比较器装置,它接受来自第一剂量记忆装置的信号和储液器储量记忆装置的信号并控制电动马达的操作。在比较器装置的帮助下,所希望的胰岛素剂量的设定值和所能利用的胰岛素储量相比较,如果设定值超过可用的储量电动马达的动作被比较器装置所关闭,这里,就不会有胰岛素被输进。按照本注射笔的推荐实施例,显示器和(或)声调信号产生器是由比较器装置共同控制,这样,可以使病人注意到胰岛素储量少于他所需注射量的情况。
按照本发明的注射笔的一个推荐实施例,控制单元包括一个定时装置,它接受一个对应于储量情况的信号,然后对此作出反映,控制电动马达的操作。这一设施使电动马达把泵杆压在活塞上的力维持在一定的大小。依靠定时装置,电动马达工作一定时间后,可以停止运转。和所想象的情况相反,因为反压力超过泵压力,不会发生输送胰岛素的情况,由于电动马达的停止转动为防止胰岛素注射到不希望的地方,(例如在多脂肪的组织中)提供了一个额外的安全保护。
按照本发明的注射笔的另一个推荐实施例,记忆装置中分配有第二剂量记忆装置,用来存入对应于剂量设定值的数据,第二剂量记忆装置由电池直接供电,第二剂量记忆装置在注射笔被关掉以后也保持所存数据,在注射笔再被打开时,借助第二剂量记忆装置仍能获得先前的胰岛素注射量的信息。
电动马达可以是双向旋转结构,这样按照本发明的注射笔也可使用非事先注入胰岛素的药液筒。结果,泵杆也可以在反方向移动。然后,活塞在储液器中移动,胰岛素在这样造成的反压力的作用下,被抽进来。这样就具有了使注射笔也可以被用来在没有预先充液筒的情况下使用的优点。
上述的各装置最好包括在一个固体电路中,这样,控制单元就能保持较小。因而使本发明的注射笔尽管有许多功能,它的尺寸仍可保持在一定限度内,所以本发明的注射笔轻巧而且便于使用。
按照本发明的注射笔将根据附图进行描述,其中;
图1是表示注射笔结构的示意图。
图2是沿着图1箭头11-11方向的剖面图,但摘掉了笔帽。
图3表示注射笔电子控制单元的框图。
在图1中的注射笔1的空腔26中装有一个盒2,盒内装有一个胰岛素储液器3和泵杆4以及作为泵杆的驱动机构的电动马达6。马达6可以是直流马达,胰岛素储液器3可以是一个商业上可买到的注册商标为Actrapid HM Penfill的筒。
如图1所示,注射笔1处于准备使用的状态,针头单元28,包括一个针头和一个针头固定装置,已经旋在头部上,这时帽27已经从头部上摘下,并装在笔1的起动单元24上。当使用针头单元28时,位于笔1内的针头被推进储液器的胶皮膜片和里边所盛的胰岛素相接触。在储液器另一端,有一活塞29可在储液器中移动,用来迫使胰岛素通过针头进入和针头相连的患者组织,活塞29的移动是由泵杆4的平移产生的,而杆4的平移是靠齿轮/传动系统8转换电动马达6的旋转运动而造成的。
图1也显示了一个向电动马达6和电子控制单位7供电的电池9,以后它将进一步在说明书中得到解释,通过板31可以更换电池9,主开关25用来开关注射器,而且图1中可看到一个观察窗32,可以装在注射笔1的任一侧。它可用来获得关于储液器储量情况的信息,这个信息是除电子控制信息外的一个额外特点。
图1所示的注射笔,尽管有电动马达和电子控制单元,其尺寸之小仍使患者可以方便地携带,例如,可放在夹克内的衣袋中,这就使患者容易得到可供注射的条件。例如,注射笔1可以长14cm,宽2cm,高3cm。
注射笔1的平面形状可以从图2中清楚看出。同样也可以看到一个夹子,它可用来把笔夹到一个夹克内的口袋上。
图3中的方框图显示出带有几个相互联系部分的电子控制单元的结构示意图。所有的部分都对应于注射笔的一个推荐实施例。在控制单元中,至少包括一个集成电路,电路连有一个程序控制器,一个记忆单元11,记忆单元11又包括一个第一剂量记忆单元19,一个第二剂量记忆单元23和一个储液器储量记忆单元19,电路中还有一个上/下计数电路16用在第一剂量记忆单元12上,一个下记数电路18也用在第一剂量记忆单元12上,一个上/下记数电路12用在储液器储量记忆单元19上以及一个计算器22。而且它还包括一些门电路33,34,35,36,37。显示器13和/或声调信号发生器14,传感器17,剂量设定单元15和电动马达6都和电子控制单元7相接。而且,图3也表示出电池9,主开关25,起动单元24和按钮30。
控制单元7中各装置的相互关系和它们与控制单元以外的各部分的关系将进一步借助一个完整的工作循环来说明。
操作主开关25接通注射笔1,显示器13的读数为零。按动按钮30,存在第二剂量记忆单元33中的数据经过“与”门电路37,也被存进第一剂量记忆单元12,接着,有选择地通过“异”门电路36,在显示器13上表示出剂量的单位数。这个剂量单位数等于在上次注射的剂量单位数。因为第二剂量记忆单元23是由电池9供电,所以这个数据不管主开关25的位置如何都被保留下来。
如果病人想改变显示在显示器13上的剂量单位数,他可以按剂量设定单元15的“+”号钮或“-”号钮。经过上下计数电路16,第一剂量记忆单元12中的数据和显示器13上剂量单元数就可根据病人的愿望得到调整。代替显示器13或除了显示器13之外,还可设置一个声调信号发生器14。用它使一个有视觉障碍的使用者根据不同音的高声调信号也能获得相同的信息,不同的音高对应于不同剂量单位数,剂量设定数的每一次改变都发一声短的声调信号。
在所需剂量单位数已设定而且剂量设定单元15已被输入,设定值借助于比较器20和作为数据存入储液器储量记忆单元19中的储液器中的胰岛素储量比较。当所设定的剂量数超过储液器中的胰岛素单位数,比较器20就使起动单元24不动作,而且它还使显示器13闪光和/或使声调信号发生器发出某种声调的信号。为此目的,比较器20经“异”门电路36和第一剂量记忆单元12相连并连到显示器13和(或)声调信号发生器14上。依靠操作剂量设定单元15的“-”号钮。存在第一记忆单元12中并在显示器13上显示和(或)由声调信号发生器14而被听到的设定剂量,一次减小一个单位。显示器13继续闪光和/或声调信号发生器继续发出上述声调信号一直到设定的剂量单位数和储液器中所盛的胰岛素的单位数一致。这个数作为数据存在第二剂量记忆单元23中。当剂量单位的设定数小于或等于盛在储液器中的胰岛素单位数,那么作为数据存在第一剂量记忆单位12中的设定数也作为数据存在第二剂量记忆单元23中。
接着,一个无菌包装的针头单元可旋进注射笔1的头部中,针的一端放在笔1之中并穿进储液器3中。这时,病人可以把注射笔1放到所希望的体位。设定的胰岛素剂量的注射可以推动帽27而起动,帽27放在起动器单元24上。当帽被压下,电池9即向电动马达供电,移动泵杆4向前,这样储液器3中的活塞29通过针头迫使胰岛素进到病人身体中。
起动单元24,比较器20和第一剂量记忆单元12可以通过“与”门电路33和34与电动马达6相连接。
借助传感器17,可以观察到电动泵杆4在每注入一个胰岛素单位时的进度。在每一单位胰岛素被注射时,下计数电路18使存入第一剂量记忆单元12中的数据与传感器17相适应,上/下计数电路21使存入储存器储量记忆单元14的数据与传感器17相适应,当存在第一剂量记忆单元12的数据变化时,在显示器13上显示的或因声调信号产生器14而被听到的仍需注射的胰岛素单位数也同样改变。这样病人就可以知道注射的进度。
当存在第一记忆单元12中的数据零于零,也就意味着此时设定的剂量都注射了,因为有门电路34的存在,电池对电动马达的供电中断。因为储液器储量记忆单元19和第二记忆单元23是直接由电池供电,存入其中的数据在主开关25关掉之后仍保存着。
当病人把注射笔针头插入体内时,很容易发生这样的情况,就是针头也许插得不够深,也就是插入多脂肪组织中,因为此时针头所接触的组织比皮下较深处有更多的网状组织因而反压力较高。在这种情况下,使用本发明的注射笔就可以防止注射不需要的胰岛素,因为活塞在储液器中的向前运动并不受病人的手动力的影响,而是受电动马达6提供的力的影响。由这个电动马达施加在活塞29上的力是有限制的,例如10约牛顿,这足以使注射进连接组织而不会在错误地方进行不希望的注射(例如在多脂肪组织中)。为了防止电动马达在胰岛素的注射不发生时仍在运行,计时器22连在控制单元7上。这个计时器22能够从储存器储量记忆单元19收到信号,这个信号对应于存在它之中的数据,如果在储液器储量记忆单元19中这个数据在某一个时期(例如1秒钟)不变,那也就意味着没有注射发生,它就可以通过“与”门电路35使电动马达6停下,电动马达也有防止飞车的安全保护。
电动马达6可以做成正反转结构,这样,泵杆以及活塞可以在相反方向移动。如果病人手头没有注满胰岛素的药液筒,在这种正反转结构的作用下,装在注射笔1中的空的储液器3也可以靠把针头插入外部胰岛素中而被充满。然后,再借助马达6使储液器3中的活塞回位。由于有传感器17和上/下计数电路21的存在,储液器储量记忆单元19中的数据和储液器3的注满率一致,这样就会产生以下情况:一个空的储液器1无须注液而是被一个预先注满胰岛素的储液器代替。如果能够得到这种注液器的话。
为了使具有以上功能的注射笔还具有便于携带的尺寸,按照推荐实施例的注射笔中的上述控制单元7,记忆单元11,电路16,18,21比较器20和计时器22组合在一个固定电路中。门电路33,34,35,31和37也组合在这个固体电路中,这样,就得到一种非常便于患者使用的注射笔,除了便于携带的设计之外,也能执行相当多的便于使用该注射笔的功能。
Claims (9)
1、可适于在病人衣服中携带的注射笔,包括一个装有可变容积的注射液储液器或筒的空腔;一个泵杆,可以相对于所说的储液器或筒改变位置,以便改变储液器的容积,一个驱动机构,用来移动上述泵杆,这种注射笔的特征在于,所说的驱动机构(5)包括有一个电动马达(6),它由包括有记忆装置(11)的电子控制单元(7)来控制,该记忆装置分配有一个作为第一剂量记忆装置(12)的区域,用来存入和注射液的准确剂量单位数对应的数据;注射笔内还有一个可在外部操作的剂量设定单元(15);用来设定上述数据以及一个由上述第一剂量记忆装置来控制,用来对病人表示上述准确数量的显示器(13)和/或一个声调信号发生器(14)。
2、按权利要求1所述的注射笔,其特征在于一个测量在上述储液器或筒中的储量的测量单元,上述控制单元(7)包括一个下计数电路装置(8),它受来自上述测量单元的数据控制,相应地减少存在上述剂量记忆装置(12)中的数据。
3、按照权利要求2的注射笔,其特征在于,上述记忆装置(11)具有分配为储液器储量记忆装置(19)的区域,用来存入对应于在上述储液器或筒中的注射笔单位数,上述储液器储量记忆装置(19)直接由位于上述空腔中的电池(9)供电,其特征还在于,上述控制单元(7)有一个上/下计数电路装置(21),它受来自上述测量单元的数据控制,并改变上述储液器储量记忆装置中所存的数据。
4、按照权利要求2或3所述的注射笔,其特征在于,上述测量单元(17)包括有一个传感器,用来测量上述泵杆(4)的位置。
5、按照权利要求3或4的注射笔,其特征在于,上述控制单元7包括有比较器装置(20),它接受来自上述第一剂量记忆装置(12)和上述储液器储量记忆装置(19)的信号,上述比较器装置(20)控制上述电动马达6以及上述显示器(13)和/或声调信号产生器(14)的工作。
6、按照上述权利要求中的任一项所述的注射笔,其特征在于上述控制单元(7)包括有定时装置(22),它接收对应于在上述储液器或筒的储量情况的信号,并根据这些信号控制上述电动马达(6)的工作。
7、按照上述权利要求中任一项所述的注射笔。其特征在于,上述记忆装置(11)具有分配为第二剂量记忆装置(23)的区域用来存入与第一剂量记忆装置(12)中所存数据相应的数据,上述第二剂量记忆装置直接由上述空腔中的电池(9)供电。
8、按照上述权利要求中任一项所述的注射笔,其特征在于,上述记忆装置(11,12,19,23),上述比较装置(20),上述下计数电路装置(18),上述上/下计数电路装置(21)以及上述定时装置(22)都设在一个集成电路内,这个电路和程序控制器相连,并且包括在所说的控制单元(7)中。
9、按照上述权利要求中任一项所述的注射笔,其特征在于,上述电动马达是可以正反转的,用来使上述泵杆(5)回位,因而可以使上述的储液筒充上注射液。
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NL8701091A NL8701091A (nl) | 1987-05-08 | 1987-05-08 | Injectiepen. |
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- 1988-05-04 DE DE8888200883T patent/DE3863979D1/de not_active Expired - Lifetime
- 1988-05-04 AT AT88200883T patent/ATE65701T1/de not_active IP Right Cessation
- 1988-05-04 EP EP88200883A patent/EP0293958B1/en not_active Expired - Lifetime
- 1988-05-04 PT PT87401A patent/PT87401B/pt not_active IP Right Cessation
- 1988-05-05 ZA ZA883227A patent/ZA883227B/xx unknown
- 1988-05-06 KR KR1019880005257A patent/KR880013584A/ko not_active Application Discontinuation
- 1988-05-06 JP JP63111387A patent/JPS63286166A/ja active Pending
- 1988-05-06 CN CN198888102557A patent/CN88102557A/zh active Pending
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- 1988-05-06 FI FI882151A patent/FI882151A/fi not_active Application Discontinuation
- 1988-05-06 DK DK250788A patent/DK250788A/da not_active Application Discontinuation
- 1988-05-06 AU AU15817/88A patent/AU1581788A/en not_active Abandoned
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US8926553B2 (en) | 2000-12-22 | 2015-01-06 | Christopher Nigel Langley | Pen-type injector having an electronic control unit |
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CN103764205B (zh) * | 2011-09-08 | 2016-08-31 | 梅纳里尼国际业务卢森堡股份有限公司 | 用于药物剂量的自动注射的设备 |
CN103889483A (zh) * | 2011-10-07 | 2014-06-25 | 松下健康医疗器械株式会社 | 药剂注入装置、药剂注入装置的控制方法、程序以及记录介质 |
CN103889483B (zh) * | 2011-10-07 | 2016-09-28 | 松下健康医疗控股株式会社 | 药剂注入装置、药剂注入装置的控制方法、程序以及记录介质 |
US9943647B2 (en) | 2011-10-07 | 2018-04-17 | Panasonic Healthcare Holdings Co., Ltd. | Pharmaceutical injection device, method for controlling pharmaceutical injection device, and recording medium |
CN103127579A (zh) * | 2011-11-21 | 2013-06-05 | 上海泽生科技开发有限公司 | 便携式注射泵的驱动系统 |
CN103656782A (zh) * | 2012-09-21 | 2014-03-26 | 上海微创生命科技有限公司 | 用于监控胰岛素笔的输注的方法和装置 |
CN103656782B (zh) * | 2012-09-21 | 2016-04-13 | 上海微创生命科技有限公司 | 用于监控胰岛素笔的输注的方法和装置 |
Also Published As
Publication number | Publication date |
---|---|
DK250788A (da) | 1988-11-09 |
NO881992D0 (no) | 1988-05-06 |
DK250788D0 (da) | 1988-05-06 |
PT87401A (pt) | 1989-05-31 |
DE3863979D1 (de) | 1991-09-05 |
EP0293958B1 (en) | 1991-07-31 |
ATE65701T1 (de) | 1991-08-15 |
NO881992L (no) | 1988-11-09 |
IL86297A0 (en) | 1988-11-15 |
JPS63286166A (ja) | 1988-11-22 |
ZA883227B (en) | 1989-01-25 |
FI882151A (fi) | 1988-11-09 |
US4950246A (en) | 1990-08-21 |
BR8802223A (pt) | 1988-12-06 |
KR880013584A (ko) | 1988-12-21 |
FI882151A0 (fi) | 1988-05-06 |
PT87401B (pt) | 1993-09-30 |
AU1581788A (en) | 1988-11-10 |
NL8701091A (nl) | 1988-12-01 |
EP0293958A1 (en) | 1988-12-07 |
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