CN1177623C - 带有预定剂量的电子显示的注射装置 - Google Patents

带有预定剂量的电子显示的注射装置 Download PDF

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CN1177623C
CN1177623C CNB971929920A CN97192992A CN1177623C CN 1177623 C CN1177623 C CN 1177623C CN B971929920 A CNB971929920 A CN B971929920A CN 97192992 A CN97192992 A CN 97192992A CN 1177623 C CN1177623 C CN 1177623C
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拉斯·彼得·克里特莫斯
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亨里克·埃戈斯伯格·汉森
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Abstract

一种注射装置具有信号发生器(11，12，13，14)，它们与装置的工作元件(8，3，5，4)连接并给出代表装置的工作状态的信号。这些信号被送到一个电路，该电路控制装置的工作状态的显示，并通过关闭一个用来显示装置的工作状态的显示器，把被确定为不允许的工作状态组合显示为差错指示。来自每个发生器的信号数被计数，超过所讨论的信号发生器的预定数的操作数被解释为代表不允许的工作状态。

Description

带有预定剂量的电子显示的注射装置
技术领域
本发明涉及用于预定剂量药物的注射的注射装置，该装置的工作状态由一个电路电子显示，该电路从与装置的工作元件连接的信号发生器接收一种模式的输入信号。
背景技术
此注射装置可以具有这样一种形式，即，包括一个剂量设定轮、一个注射按钮、和一个保护帽，该保护帽至少覆盖装置的针头接收部分，还可能覆盖该剂量设定轮。电子显示通常是电子显示器的形式，但是也可以使用语音电路以语音方式概述装置的状态。也可以设想一种呈现触觉内容的机电装置。
与装置的工作元件连接的发生器可以是用来接通和断开电流开关，或者它们可以是有源电流发生器。开关型的发生器可与保护帽或注射按钮连接两个交替位置之一，即，帽盖上或帽去掉，或按钮凸起或压下。
有源型发生器在被激励时自身产生电流，它与剂量设定轮连接以提供反映该轮的转动的电流信号，例如，通过转动该轮设定每一个单位产生一个脉冲，该脉冲具有极性，指示剂量设定通过轮的转动增大或减小。也可以通过操纵几个开关来提供剂量设定信号。
相对于机械显示而言，使用装置参数的电子显示可以使用具有大位数的显示。在机械显示中，剂量设定轮和柱塞的运动将显示位数的大小限制得很窄。该柱塞操纵带有要注射的药物的针管内的活塞。
电子显示依赖于电开关和发生器，可能，由于例如磨损而不报警以及运行错误的电信号得到错误的显示。对于机械装置，磨损可能由更加松动的装置本身显现，也可能不由它本身显现。
发明内容
因此，本发明的目的是提供一种装置，在不可靠的电或机械元件引起该装置注射药物的错误剂量之前检测这些元件。
这可以通过一种如本说明的首段所描述的装置来实现，该装置的特征在于它包括一个电路，该电路接收来自与装置的工作元件连接的信号发生器的输入信号，给出代表装置的工作状态的信号，并控制所述工作条件的显示。
根据本发明，被定义为不允许的工作条件可以显示为差错指示。而且，根据本发明，至少信号发生器之一是一个产生电信号的有源发生器。
根据本发明的一个实施例，该电路包括一个存储器，其中存储了用于装置的所有允许工作条件的信号模式，来自信号发生器的信号被经常与存储的信号模式比较，如果在允许的模式中没有找到该信号模式，则产生一个差错指示。
差错可以通过关闭装置的工作条件的显示来指示。
允许的信号模式是这样的模式，它们在装置的正常的非错误使用期间发生。假定装置具有一个剂量设定轮，当保护帽装在该装置上时该轮被保护帽覆盖。这种情况下，一种模式的信号包括一个指示帽盖上的信号和另一个指示剂量设定轮被操纵的信号，这一模式是不被允许的，因为当剂量设定轮被帽覆盖时不能被操纵，这显示了一个明显的逻辑矛盾。如果提供了锁定装置来排除注射器的两个元件的同时工作，那么指示这两个元件被同时操纵的信号会引起一个差错指示。
在根据本发明的装置的一个实施例中，电路可被设计成计数从每个信号发生器送来的信号数，将这些数字与存储在电路内的设定值比较，当这些数字之一超过该信号发生器的设定值时给出一个信号，该信号产生一个差错指示。通过这一特征，可以保证该装置只被用于几种操作，并且在由于磨损可能出现而失效之前以一个新的装置来替换。
如果开关磨损到使其稳定性成问题的程度，则这将表现为当开关应该接通时看起来是断开的或者反之亦然，这将导致不被允许的信号模式。当这一模式被检测为不在允许的模式中时，电路将关闭参数的电子显示，并且装置被停用。
由于不被允许的信号模式可能由与装置状态无关的事件引起，例如由附近任何电子设备产生的瞬间电磁场引起，故该电路可以在其关闭电子显示时被复位以重新允许此显示。如果电子显示的关闭是由装置外的事件引起的，则装置在复位后可重新使用。但是如果不被允许的信号模式是由失效的开关引起的，则该开关将很快再次失效并关闭电子显示。
另一种功能检查可以通过从更换针管时算起的注射剂量的总和来实现。如果累计的剂量超过了一个新针管内的总容量，则例如通过关闭电子显示，报告一个差错。
由于认识到当开关和发生器已经使用多次时，其失效的可能会大大增加，故电路可被设计为计数从每个信号发生器送来的信号数，将这些数与存储在电路内的设定值比较，当这些数之一超过该发生器的设定值时给出一个信号，该信号形成代表装置状态的信号模式的一部分，并使该模式不被允许。结果，当一个信号发生器的计数达到该发生器的设定值时使该装置停止工作。
由于根据来自信号发生器的信号的计数使装置停止工作是可以预见的，因此当发生器之一产生的信号数接近该发生器的设定数量时，向用户显示一个报警。这样，用户可以避免装置突然失效的不便。
为了进一步避免装置的突然失效，电池状态被实时的监测，并且在电池完全耗尽之前的某时指示电量不足。
开关和发生器的失效不能被预见，从而引起装置突然停止工作。对于应急，电路可以被复位，装置可以在被使用几次，除非开关已经如此不可靠以致于该装置立刻再次停止工作。
根据本发明，这里提供一种注射装置，包括一个电路，用于从信号发生器接收输入信号，所述的信号发生器与所述的注射装置的工作元件相连接，所述的电路发出代表所述注射装置的工作状态和控制所述工作状态的显示的信号，其特征在于，已被确定为不允许的组合的至少两种工作状态的组合作为一个差错指示被显示。
附图说明
图1示意表示带有电信号发生器的注射装置。
图2表示如何操作才能使本发明的注射装置从一个状态到另一个状态的示意图。
具体实施方式
图1的装置包括以下的工作元件：
-剂量设定轮4，通过转动它可以设定剂量
-注射按钮5
-盖子3，覆盖外壳1内的盒2
-可去除的保护帽8，覆盖剂量设定轮4以及盖子3。
还提供了以下机械锁定装置：
-当按钮5被压下时，被锁定在该位置。当操作剂量设定轮4时按钮5被释放。因此在设定剂量期间，按钮5不能处于压下位置；如果按钮5保持在压下位置，则剂量设定轮不能转动。锁定装置的正确功能由前述的电子装置通过分析一个信号来检查，该信号指示一个由于不被允许而被锁定的操作。
-当盖子3打开时，剂量设定轮4被锁定。当盖子3的打开作为一条规则被执行以更换盒2时，该锁定是恰当的。在更换盒2时，一个活塞杆必须向后移动为新的装满的盒留出空间，从而剂量设定机构与活塞杆之间的耦合被释放以使活塞杆可以自由移动。通过该活塞杆，当按钮5被压下时，与设定剂量对应的运动被传递到盒内的一个活塞。当所述的耦合被释放时剂量设定轮4的转动会激励与所述轮耦合的发生器，使得用户认为他在设定一个剂量，但是由于耦合的释放，通过按钮5的操作，没有剂量或只有错误的剂量被注射。为了避免这样的故障，就建立所述机械锁定装置。而且通过该锁定装置，由电子装置通过分析一个指示不被允许而应被锁定的操作的信号来检查正确的功能。
当设定一个剂量时，可以通过压下按钮5来注射。注射通过针头6来进行，该针头通过携带针头的针头柄7安装在注射器上。
按钮5、盖子3和帽8分别与点13、12、11所指示的开关结合。每个开关具有两个位置，通或断，使得开关的位置代表与所述开关结合的元件的状态。这些状态是：
-帽盖上或去掉
-按钮下(压下)或上(没压下)
-盖子关上或没关上(打开)
由上述三个开关的位置定义的八种状态示于表1中。
转动剂量设定轮4将导致来自与剂量设定轮协作的信号发生器14的信号发出对应于轮的转动程度的多个脉冲，并且脉冲具有极性，通过极性来指示轮4的转动是引起设定单位数的增加还是减小。
                                                表1
状态        I         II          III         IV         V         VI         VII         VIII
帽          盖上      盖上        盖上        盖上       去掉      去掉       去掉        去掉
按钮        下        下          上          上         下        下         上          上
盖子        打开      关上        打开        关上       打开      关上       打开        关上
允许        -         +           -           +          +         +          +           +
剂量设定    -         -           -           -          -         -          -           +
如从表1所见，状态I和III是不被允许的，因为当帽盖上时盖子不能打开。
在开关的允许状态中，只有在状态VIII下剂量设定信号才可以被接受。开关处于状态I至IV时，剂量设定轮不能被操作，因为帽8是盖上的。在状态V和VI下，剂量设定轮不能被操作，因为按钮5处于压下位置；如果电路仍然收到一个剂量收到信号，则指示按钮为下时锁定剂量设定轮的锁定装置的故障。
当开关处于状态VII时，剂量设定信号将指示盖子打开时锁定剂量设定轮的锁定装置的故障。
每个开关可以只用作其自身的用途。当帽盖上时，帽盖上/去掉开关11可以关闭显示器以节电。而且当帽被摘掉时，开关11的启动可以开始一个显示器检测，通过该检测，显示器中的所有段被短暂启动以使用户知道是否所有段都是工作的。当按钮被压下并且一次注射已完成时，按钮下/上开关13可以指示如果按钮没有完全压下则注射没有完成以及设定剂量没有被注射。而且，此开关可以复位，并启动一个停表，以指示自从上次注射所过去的时间。盖子打开/关闭开关12指示盒的可能更换，并将设定剂量从电子显示，例如从显示器删除，因为必须在能够设定剂量之前，执行一个保证活塞杆紧靠新盒的活塞的盒移位程序。如果电路的故障反应是由环境事件，例如瞬间的电磁场引起，则盖子的打开和关闭也可以复位一个电路的可能故障反应，使该装置重新操作；然而，如果故障反应是由于装置本身的故障引起的，则故障反应会很快再次发生。
可以进行以下动作
-a1可以去掉帽
-a2可以将帽放回原位
-a3可以部分打开针管盖子
-a4可以完全打开针管盖子
-a5可以部分关闭针管盖子
-a6可以完全关闭针管盖子
-a7可以增加剂量设定
-a8可以减小剂量设定
-a9可以部分压下或释放注射按钮
-a10可以完全压下注射按钮
-a11可以释放注射按钮
在图1中表示了这些动作如何使开关不改变，或将其从允许的六种组合之一变为另一组合。
当装置处于状态II，帽盖上，只有一种处理是可能的；帽可以被去掉，即a1，将装置变为状态VI。通过再戴上帽，即a2，将装置从状态VI变回状态II，或者通过分别部分或完全打开针管盖子，即经a3或a4处理，可以变为状态V，或者通过释放注射按钮，即a11，变为状态VIII。
应当注意，帽8、盖子3、和按钮5的状态描述是，
1.帽盖上或没盖上
2.盖子打开或没打开
3.按钮完全压下或没有完全压下。
这可以解释为当帽只是几乎盖上时，它是去掉的；当盖子没有完全关上时，它是打开的；当按钮没有完全压下时，它是上。
在状态V中盖子可以多少被打开或关上，只要它没有完全关上，则装置将保持在状态V。同样只要盖子没有完全关上，即a6，或注射按钮没有完全压下，即a10，则装置将保持在状态VII。
由于提供了机械锁定装置，故只有当装置处于状态VIII时才能进行剂量设定，因此剂量设定轮的操作不应使装置离开状态VIII。如果在开关处于另一状态时收到剂量设定信号，则可以解释为故障指示。
应当注意，在该装置的其他实施例中，可以提供其他的锁定装置和开关来控制注射器的其他功能。例如在一个优选实施例中，通过提供锁定装置，使得状态VII成为不被允许的状态，该锁定装置防止当按钮为上时盖子被打开，并相应地防止当盖子打开时按钮为上。为表明这样的实施例的可能的状态，在图2中不仅状态VII应当被删除，而且导致该状态的a3和a11，以及导致状态VII变到状态VIII和V的a6和a10也应当被删除。

Claims (7)

1.一种注射装置，包括一个电路，用于从信号发生器(11，12，13，14)接收输入信号，所述的信号发生器与所述的注射装置的工作元件(8，3，5，4)相连接，所述的电路发出代表所述注射装置的工作状态和控制所述工作状态的显示的信号，其特征在于，已被确定为不允许的组合的至少两种工作状态的组合作为一个差错指示被显示。
2.根据权利要求1所述的装置，其特征在于，至少一个所述的信号发生器是具有断开和接通位置的电开关，该开关用于断开或接通电流。
3.根据权利要求1或2所述的装置，其特征在于，至少一个所述信号发生器是一个有源发生器，用于产生电信号。
4.根据权利要求1所述的装置，其特征在于，所述的电路包括：一个存储器，其中存储输入信号的所有模式，它们对应于所述注射装置的允许状态，
来自所述信号发生器的所述信号的模式经常与所述的存储的信号模式相比较，和
如果该信号模式在允许的模式中未被找到，则给出一个差错指示。
5.根据上述权利要求之中的任一个所述的装置，其特征在于，所述的电路被设计为：对从每个所述信号发生器发送的信号数目计数；将这些数目与存储在所述电路中的设定值相比较，并且在这些数目之中的一个超过所涉及的信号发生器所使用的设定值时，发出一个信号，该信号引发一个差错指示。
6.根据上述权利要求之中的任一个所述的装置，其特征在于，一个差错指示是通过关闭所述注射装置的工作状态的显示形成的。
7.根据权利要求6所述的装置，其特征在于，当所述的电路关闭电子显示时，它可被复位，以允许该显示。
CNB971929920A 1996-03-12 1997-03-03 带有预定剂量的电子显示的注射装置 Expired - Fee Related CN1177623C (zh)

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