CN101035579B - 用于药物输送装置的剂量显示机构 - Google Patents
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Abstract
本申请涉及一种用于药物输送装置(1)的剂量显示机构,所述药物输送装置允许使用者选择多剂量的可注射药物并用于分配设定剂量的所述药物以及优选通过注射向病人应用所述药物。
Description
技术领域
本发明涉及一种用于药物输送装置的剂量显示机构,所述药物输送装置允许使用者选择多剂量的可注射药物并用于分配设定剂量的所述药物以及优选通过注射向病人应用所述药物。特别地,本发明涉及可由病人自行操作的这类装置。
背景技术
允许对所需剂量的液体药物进行多次定量给药并向病人施用所述液体的药物输送装置是本领域内公知的。通常,这类装置基本上与普通注射器具有相同的用途。
这种类型的笔型注射器必须符合多种要求以满足使用者的需要。这些装置必须结构坚固,并且在对其部件的操作和使用者对其操作的理解两方面都必须简单易用。对于糖尿病患者而言,许多使用者身体虚弱并且可能视力衰退。在注射器是一次性而不是可重复使用的情况下,注射器应当制造廉价并易于处理(优选地,适于回收)。
WO 01/87386 A1教导了一种用于药物施用装置的机械式剂量显示装置,其包括至少一个由剂量设定致动器驱动的柔性圆盘,该柔性圆盘沿其周边带有一组数字。通过将所述圆盘以使其周边的直径方向上的相对点会合(meet)的方式合拢,可允许沿所述周边的每个数字变成写在一圆筒上的相应数字的大约三倍,所述圆筒具有与由被合拢圆盘形成的管的直径相对应的直径。通过添加一第二圆盘可显示一个两位数。
WO 98/10813 A1公开了一种剂量设定机构,通过该机构,剂量可显示在一圆形刻度盘上,该圆形刻度盘具有固定在壳体上的第一部分和相对于该第一部分可转动的第二部分,该第二部分连接到剂量设定元件上。所述部分的其中一个具有刻度,另一个具有在所述刻度上指示一个点的指示元件。通过使用圆形刻度盘,所述刻度盘可制作得任意大,其仅仅受到装置不能太大的限制。
US 5279585 A公开了一种用于将液体例如胰岛素注射到身体组织内的注射装置。该装置的剂量设定构件包括个位计数器环、邻接该个位计数器环设置的十分位计数器环,以及连接所述个位计数器构件与所述十分位计数器环的传递构件。
发明内容
因此,本发明要解决的问题是提供一种剂量显示装置,其以清晰和较大的标示(示数/indices)即数字、符号、字母等显示所设定的剂量,并且适合于视力残疾的使用者使用,尤其适合用于笔型药物输送装置。
本发明的第一方面是提供一种用于药物输送装置的剂量显示机构,包括:
剂量设定刻度件(dial),该剂量设定刻度件具有从近端延伸至远端的外螺纹和外部槽;以及
计数器环,该计数器环与所述剂量设定刻度件的外部槽成互锁关系,使得在阻止所述计数器环相对于所述剂量设定刻度件旋转的同时,该计数器环可相对于所述剂量设定刻度件沿所述外部槽自由地轴向移动。
本发明的第二方面是提供一种药物输送装置,其包括:a)驱动机构,和b)本发明的剂量显示机构。
本发明的第三方面是根据本发明的剂量显示机构在用于组装本发明的装置的方法中的应用。
本发明的第四方面是根据本发明的装置向人或动物的身体施用药物制剂(pharmaceutical formulation)的应用。
本发明的另一个方面是组装根据本发明的药物输送装置的方法,该方法包括将根据本发明的机构安装到任意部件上以便组装药物输送装置的步骤。
用于限定本发明的术语通常应当根据本领域技术人员的一般知识加以理解。此外,根据本发明,以下术语应当可选地优选具有下列含义:
根据本发明的术语“药物输送装置”应当优选地理解为多剂量的、一次性的、可移动的、手持式装置,其用于分配选定剂量的药物,例如胰岛素、胰岛素类似物、生长激素、低分子量肝素和它们的衍生物等,并且可选地适合于自行施药。所述装置通常为机械式的。更优选地,术语“药物输送装置”应当理解为一次性的、多剂量的笔型装置,其具有机械式的剂量输送和剂量选择机构,可由未经正式医疗培训的人例如病人进行常规的注射。
通常,本发明的“药物输送装置”包括容纳药物制剂的药筒以及可选地包括药筒保持器,其中可通过针头施用所述药物制剂。
术语“药物制剂”应当优选地理解为容纳在所述药筒中的液体或悬浮液等,包括药物或疫苗。所述药物可包含一种或多种可进行皮下注射的蛋白质、肽或小分子。优选地,所述药物为一种或多种激素或抗血栓药,并且尤其选自于胰岛素、肝素以及它们的衍生物、类似物和替代物。
根据本发明的术语“剂量设定刻度件”应当优选地理解为基本上具有圆形横截面的基本上为管状的元件,该元件具有通过第一螺旋结构与壳体相接合的外螺纹,从而允许所述剂量设定刻度件在剂量设定过程中可旋转地向近端移动以及在剂量分配过程中可旋转地向远端移动。根据本发明的“剂量设定刻度件”用于指示可分配药物制剂的选定剂量。这可通过使用例如印制在所述剂量设定刻度件的外表面上的标记、符号、数字等来实现。此外,所述剂量设定刻度件通过一离合器装置可释放地连接到内筒体。为了设定剂量,所述剂量设定刻度件可以被旋转并且该剂量设定刻度件和所述内筒体一起向近端旋转。在药物分配过程中,所述离合器装置可以从所述内筒体上分离所述剂量设定刻度件,从而该剂量设定刻度件可相对于所述内筒体向远端旋转。另外,所述剂量设定刻度件可包括一个或多个止动部以限制单次剂量的最大量。
根据本发明的术语“内筒体”应当优选地理解为基本上具有圆形横截面的基本为管状的任意元件,该元件可释放地连接到所述剂量设定刻度件上,从而所述剂量设定刻度件和所述内筒体之间的相对转动在剂量设定过程中被阻止,但是在剂量分配过程中被允许。在一优选实施例中,所述内筒体还通过自由锁装置与活塞杆接合。在剂量分配过程中,所述内筒体通过离合器装置与剂量设定刻度件分离并且(相对于壳体)无旋转地向远端移动。
根据本发明的术语“可释放地连接”应当理解为:本发明的机构或装置的两个元件彼此可逆地连接,从而允许连接和分离。这例如通过离合器装置实现。
根据本发明的术语“离合器装置”应当理解为使剂量设定刻度件和内筒体可逆地连接的任意装置,该装置设计成:当剂量设定刻度件和内筒体相连接时,允许剂量设定刻度件和内筒体相对于壳体转动;而当二者分离时,允许剂量设定刻度件相对于壳体转动,但不允许内筒体相对于壳体转动,并且允许内筒体轴向移动。因此,术语“离合器装置”是例如通过使用轴向力接合一组端面齿(锯齿、犬齿(dog teeth)、冠状齿)或任意其它适当的摩擦面而接合用于可逆地锁定两个元件使它们不能相对转动的任意离合器。
根据本发明的术语“计数器环”应当优选地理解为与剂量设定刻度件成互锁关系的元件。在一优选实施例中,所述计数器环同心地组装在剂量设定刻度件的外周(基本上为圆形),可选地与螺纹嵌入件[螺旋导引件]的前侧相邻(在远端)。
在另一优选实施例中,设置一定位装置以防止所述计数器环在剂量设定和剂量分配过程中相对于壳体轴向移动,但允许该计数器环在剂量设定和剂量分配过程中相对于壳体作旋转运动。这可通过在剂量设定刻度件的外周上邻接所述计数器环的远端而组装一定位套环来实现,可选地,该定位套环可集成在所述壳体中。
“计数器环”用于通过沿其外周的标示来指示设定剂量的量的一个数字,而设定剂量的一个或多个其它标示可沿所述剂量设定刻度件的外周来指示。优选地,“计数器环”的拨动应当可设定所述剂量的最小增量(例如,一个单位的十分度、八分度、四分度或二分度,或单个单位)。
根据本发明的术语“互锁关系”应当理解为计数器环和剂量设定刻度件之间的任意结构性连接,该连接允许计数器环和剂量设定刻度件优选通过一螺旋结构(例如,螺纹、槽、肋)相对于壳体一起旋转,并且当剂量设定刻度件移动时(或者朝近端或者朝远端),还允许该剂量设定刻度件相对于计数器环纵向地作轴向运动。优选地,当剂量设定刻度件被旋拧出以设定剂量时,计数器环在显示窗口中保持可见并且显示所设定的剂量(药物的量)。
根据本发明的术语“驱动机构”应当理解为可使力从药物输送装置的近端传递到远端以用于分配药物并且与本发明的剂量标定机构相接合的任意机构(例如,丝杠、齿条和齿轮、齿轮箱)。
根据本发明的术语“壳体”应当优选地理解为一外部的或内部的(“插入”)覆盖件。该壳体可用于使药物输送装置(例如,驱动机构)能够被安全、正确和舒适地操作。通常,所述壳体被设计成通过限制在污染物例如液体、灰尘、污物等下的暴露而容纳、固定、保护,引导和/或接合药物输送装置的内部机构或元件。通常,所述壳体可以是管状或非管状的单一部件或由多部分组成的部件。
优选地,所述“壳体”用于容纳药筒以及可选地容纳药筒保持器,该药筒保持器优选安装在所述壳体的远端。
根据本发明的术语“接合”应当理解为所述剂量显示机构/药物输送装置的两个或多个元件的互锁,优选地为所述元件的螺旋结构的互锁。
根据本申请的术语“螺旋结构”应当理解为完全的或部分的螺纹,例如位于药物输送装置的元件的内和/或外表面上的圆柱螺旋肋/槽,具有基本上为三角形或正方形或圆形的截面,用于允许元件之间的连续而自由的旋转和/或轴向运动。可选地,螺旋结构还可设计成防止特定元件在某个方向上的旋转或轴向运动。
根据本申请的术语“柱塞杆”应当理解为驱动机构的元件,其适于在所述壳体内部或穿过该壳体进行操作,用于将力从药物输送装置的近端传递到远端,优选传递到药筒活塞,以用于药物分配。
根据本发明的术语“远端”应当理解为所述装置的或该装置的元件的最接近该装置的分配端的端部。
根据本发明的术语“近端”应当理解为所述装置的或该装置的元件的最远离该装置的分配端的端部。
根据本发明的术语“丝杠”应当理解为任意的基本上为圆柱形的元件,其优选通过螺纹接合的方式与柱塞杆接合,并且在剂量设定过程中朝近端方向移动时相对于所述柱塞杆旋转,而在剂量分配过程中朝远端沿轴向移动而不旋转。在一优选实施例中,丝杠还优选通过螺纹接合的方式与一自由锁(例如,摩擦离合器、止推轴承等)相接合。
术语“自由锁”应当理解为基本上为圆柱形的元件,其接合在内筒体的内表面和丝杠之间,优选位于所述丝杠的近端。“自由锁”通过螺旋结构相对于内筒体旋转和轴向移动。
所述自由锁可相对于所述丝杠旋转,但是该自由锁不能相对于所述丝杠沿轴向运动。
根据本发明的术语“显示窗口”应当理解为所述壳体上的任意开口例如孔,或该壳体上的透明部分,其可显示所述装置的状态,优选为剂量设定的状态,特别是所设定剂量的量。这可通过剂量指示器实现,该剂量指示器呈现一个或多个数字符号和/或图形符号、值和/或字符,优选为两个或三个数字,以指示所设定的剂量。在另一个优选实施例中,“显示窗口”显示所选定的剂量的值,该值包括沿计数器环的外周显示的一个或多个数字,以及沿剂量设定刻度件的外周显示的一个或多个数字。在另一个实施例中,所述显示窗口基本上位于所述装置的近端。
本发明说明了一种包括剂量设定刻度件和计数器环的剂量显示机构,所述剂量设定刻度件和计数器环分别在其外周上显示标示,从而可显示出代表所选定剂量的两个标示。通过这种结构,可以使显示装置的标示的尺寸最大化,从而使之适合于视力受损的使用者使用。
附图说明
参照下列附图对本发明进一步作详细说明:
图1是位于剂量设定刻度件上的计数器环的透视图。
图2是示出计数器环的第一数字的数值的示意图(a)以及计数器环的透视图(b)。
图3是示出剂量设定刻度件的第二数字的数值的示意图。
图4是整个装置的透视图,其中标明了显示窗口。
图5是示出所述装置的剂量设定操作的侧剖视图。
具体实施方式
图1是包括所述剂量设定刻度件(22)和计数器环(30)的剂量显示机构的透视图,其中标明了螺旋螺纹(111)、肋槽(64)以及计数器环(30)的优选的起始位置。为了使显示窗口(62)更加清楚,图1只示出了剂量设定刻度件(22)的外表面上的一个数字(66b)。
图2a示意性地示出计数器环(30)的平面透视图。在该实施例中,计数器环(30)具有位于外表面上的个位数字(66a)。优选地,计数器环(30)的内径基本上与剂量设定刻度件(22)的外径相同。图2b示出计数器环(30)的优选实施例。如图1所示,计数器环(30)的内表面具有优选沿纵向轴线形成的肋(63),这些肋被设计成与位于剂量设定刻度件(22)的外表面上的肋槽(64)相接合。
图3示意性地示出剂量设定刻度件(22)的平面图。在该实施例中,剂量设定刻度件(22)在其外表面上具有十分位数字(66b),其优选设置成每个单独的数字例如1、2、3、...、9都出现十次,从而在一个完整的360°旋转过程中与计数器环相对应,以产生一个两位数,例如10、11、12、...、19。下一个完整的360°旋转将以20、21、22、...、29的顺序示出两位数。再下面的完整的旋转将产生与30’s、40’s、50’s等相关的对应两位数,直到最大的可能剂量。所述数字优选成螺旋形地设置在剂量设定刻度件(22)的外表面上,其螺旋形的节距对应于剂量设定刻度件(22)的螺旋螺纹(111)的节距。所述螺旋螺纹(111)和槽(62)在图3中未示出。
图4示出药物输送装置(1)中的剂量显示机构的优选实施例,其中在显示窗口(62)中示出了剂量设定刻度件(22)的数字(66b)和计数器环(30)的数字(66a)的优选位置。
图5示意性地示出药物输送装置的优选实施例,其中剂量设定刻度件(22)和计数器环(30)被组装成一驱动机构,该驱动机构在标题为“用于药物输送装置的驱动机构”的共同申请中公开,该申请结合于此作为参考。在该实施例中,剂量设定刻度件(22)经由结合在螺纹嵌入件(31)上的第一螺旋结构(35)与壳体(2)接合。剂量设定刻度件(22)可相对于壳体(2)自由旋转,并且在剂量设定过程中相对于壳体(2)向近端移动,而在剂量输送过程中相对于壳体(2)向远端移动。通过优选固定在壳体(2)的内表面上并且更优选地作为壳体(2)的一体部分而形成的定位套环(65),可防止计数器环(30)在剂量设定过程中相对于壳体(2)朝近端轴向移动以及在剂量分配过程中相对于壳体(2)朝远端轴向移动。然而,由于计数器环(30)与剂量设定刻度件(22)相接合,因此它可以相对于壳体(2)自由旋转。
Claims (9)
1.一种用于药物输送装置的剂量显示机构,包括:
剂量设定刻度件,该剂量设定刻度件具有从近端延伸至远端的外螺纹和外部槽;以及
计数器环,该计数器环与所述剂量设定刻度件的外部槽成互锁关系,使得在阻止所述计数器环相对于所述剂量设定刻度件旋转的同时,该计数器环可相对于所述剂量设定刻度件沿所述外部槽自由地轴向移动,
其中所述剂量设定刻度件和计数器环分别在其外周上显示标示,从而显示出代表所选定剂量的两个标示。
2.根据权利要求1所述的机构,其特征在于,所述机构用于向人或动物的身体施用药物制剂。
3.根据权利要求2所述的机构,其特征在于,所述药物制剂选自胰岛素、肝素以及它们的衍生物和类似物。
4.一种药物输送装置,包括:
a)驱动机构;和
b)根据权利要求1所述的剂量显示机构。
5.根据权利要求4所述的装置,其特征在于,该装置容纳胰岛素、肝素或它们的任意衍生物或类似物。
6.根据权利要求4至5中任一项所述的装置,其特征在于,所述装置用于向人或动物的身体施用药物制剂。
7.根据权利要求1所述的剂量显示机构用于组装药物输送装置的应用,其中所述药物输送装置包括驱动机构和所述剂量显示机构。
8.根据权利要求1所述的剂量显示机构用于组装药物输送装置的应用,其中所述药物输送装置包括驱动机构和所述剂量显示机构,并且所述药物输送装置容纳胰岛素、肝素或它们的任意衍生物或类似物。
9.组装药物输送装置的方法,该方法包括下述步骤:
将根据权利要求1所述的机构安装到驱动机构上,以便制造根据权利要求4至5中任一项所述的药物输送装置。
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US6663602B2 (en) | 2000-06-16 | 2003-12-16 | Novo Nordisk A/S | Injection device |
US6595960B2 (en) * | 2001-04-12 | 2003-07-22 | Becton, Dickinson And Company | Flexible needle assembly |
DE10163328B4 (de) * | 2001-07-30 | 2005-08-11 | Tecpharma Licensing Ag | Verabreichungsgerät mit Verdrehsicherung |
RU2387461C2 (ru) | 2004-10-04 | 2010-04-27 | Санофи-Авентис Дойчланд Гмбх | Приводной механизм для устройства введения лекарств |
EP1642607A1 (en) * | 2004-10-04 | 2006-04-05 | Sanofi-Aventis Deutschland GmbH | Dose display mechanism for a drug delivery device |
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2004
- 2004-10-04 EP EP04023628A patent/EP1642607A1/en not_active Withdrawn
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2005
- 2005-09-14 MX MX2007003683A patent/MX2007003683A/es active IP Right Grant
- 2005-09-14 RS RSP-2008/0512A patent/RS50664B/sr unknown
- 2005-09-14 BR BRPI0517553-4A patent/BRPI0517553A/pt not_active Application Discontinuation
- 2005-09-14 ME MEP-2008-514A patent/ME01388B/me unknown
- 2005-09-14 WO PCT/EP2005/009840 patent/WO2006037435A1/en active Application Filing
- 2005-09-14 AT AT08075101T patent/ATE438429T1/de not_active IP Right Cessation
- 2005-09-14 EP EP08075101A patent/EP1913967B1/en not_active Revoked
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- 2005-09-14 ES ES08075101T patent/ES2331439T3/es active Active
- 2005-09-14 AT AT05785102T patent/ATE403456T1/de active
- 2005-09-14 PT PT08075101T patent/PT1913967E/pt unknown
- 2005-09-14 JP JP2007533897A patent/JP4871282B2/ja not_active Expired - Fee Related
- 2005-09-14 DE DE602005008756T patent/DE602005008756D1/de active Active
- 2005-09-14 ES ES05785102T patent/ES2312016T3/es active Active
- 2005-09-14 RU RU2007116819/14A patent/RU2385741C2/ru not_active IP Right Cessation
- 2005-09-14 CN CN2005800338318A patent/CN101035579B/zh not_active Expired - Fee Related
- 2005-09-14 PL PL08075101T patent/PL1913967T3/pl unknown
- 2005-09-14 SI SI200530829T patent/SI1913967T1/sl unknown
- 2005-09-14 PL PL05785102T patent/PL1799286T3/pl unknown
- 2005-09-14 RS RSP-2009/0468A patent/RS51107B/sr unknown
- 2005-09-14 DK DK08075101T patent/DK1913967T3/da active
- 2005-09-14 PT PT05785102T patent/PT1799286E/pt unknown
- 2005-09-14 DE DE602005015899T patent/DE602005015899D1/de not_active Revoked
- 2005-09-14 UA UAA200704943A patent/UA93486C2/ru unknown
- 2005-09-14 NZ NZ554383A patent/NZ554383A/en not_active IP Right Cessation
- 2005-09-30 AR ARP050104149A patent/AR054689A1/es active IP Right Grant
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2007
- 2007-03-08 ZA ZA200702031A patent/ZA200702031B/xx unknown
- 2007-03-20 IL IL182074A patent/IL182074A/en unknown
- 2007-03-26 US US11/690,984 patent/US8202255B2/en active Active
- 2007-03-28 EG EGNA2007000323 patent/EG25099A/xx active
- 2007-04-03 EC EC2007007368A patent/ECSP077368A/es unknown
- 2007-04-03 TN TNP2007000122A patent/TNSN07122A1/fr unknown
- 2007-04-03 MA MA29793A patent/MA28914B1/fr unknown
- 2007-04-24 NO NO20072130A patent/NO20072130L/no not_active Application Discontinuation
- 2007-11-15 HK HK07112473.4A patent/HK1107034A1/xx not_active IP Right Cessation
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2008
- 2008-10-24 HR HR20080545T patent/HRP20080545T3/xx unknown
- 2008-10-30 CY CY20081101227T patent/CY1109122T1/el unknown
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2009
- 2009-11-03 HR HR20090588T patent/HRP20090588T1/hr unknown
- 2009-11-04 CY CY20091101142T patent/CY1109578T1/el unknown
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2012
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