CN102458529A - 用于填装药物输送装置的剂量设定机构 - Google Patents
用于填装药物输送装置的剂量设定机构 Download PDFInfo
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Abstract
提供了一种用于填装药物输送装置的方法和***。所述药物输送装置包括剂量调拨套筒(56、84)和内壳体部分(58、70)。所述剂量调拨套筒联接到所述内壳体。所述剂量调拨套筒在所述药物输送装置的填装期间在大致圆周旋转路径(74)上旋转。此外,所述剂量调拨套筒(56、84)在所述药物输送装置的剂量设定期间在螺旋路径(76)上旋转。
Description
技术领域
本专利申请大体上涉及药物输送装置。更特别地,本专利申请大体上涉及药物输送装置,例如笔式药物输送装置。这样的装置提供用于从多剂量筒自施予药品并且允许用户设定输送剂量。本申请可以在可重设(即,可再使用)和不可重设(即,不可再使用)两种类型的药物输送装置中得到应用。然而,本发明的各方面也可以同等地应用于其它情况中。
背景技术
在发生由未受过正式医疗训练的人进行定期注射的情况下,笔式药物输送装置得到应用。这在患有糖尿病的患者当中越来越常见,其中自我治疗能够使这样的患者能够进行他们的疾病的有效管理。
在某些类型的药物输送装置(例如笔式装置)中,使用药剂筒。这些筒容纳在筒保持器中或筒壳体中。这样的筒包括在一个端部的塞子或封堵器。在筒的另一个端部,筒包括可穿刺密封件。为了从这样的筒分配药剂的剂量,药剂输送装置具有剂量设定机构,所述剂量设定机构使用心轴在远侧方向上朝着筒移动,并且将心轴的远端压靠在塞子上。这从筒排出药剂的某个设定剂量。为了保证剂量精度,重要的是在注射药剂的剂量之前、期间和之后心轴的远端保持在筒的塞子上。
某些已知的药剂输送装置的一个已知缺点在于,由于在组成药物输送装置的各种部件的制造期间可能发生的各种公差差异(例如,可能在部件模制期间产生的公差差异)和不在已组装装置中轴向地预压塞子的要求,因此当组装药剂输送装置时,可能在心轴的端部和筒塞之间有间隙。换句话说,当初始组装时,筒(和因此筒塞)可能不与心轴的远端相接触。所以,如果第一次使用药物输送装置的用户调拨剂量,则接收到的实际剂量可能等于调拨剂量减去心轴的远端和筒塞之间的初始间隙。筒塞和心轴的远端之间的气隙可以相当于这样的剂量,所述剂量导致在优选剂量精度范围之外的接收到的剂量。例如,该气隙可以相当于第一剂量上的药品的0至10个单位(即,0-0.14毫升)的损失。
所以,当设计可重设或不可重设药物输送装置(例如笔式药物输送装置)时,通常需要考虑这些已知的问题。
发明内容
本发明的目的是提供一种尤其适合于填装药物输送装置的改进剂量设定机构。
该目的由如权利要求1中限定的剂量设定机构和根据权利要求12的方法实现。
根据示例性布置,提供了一种用于药物输送装置的剂量设定机构,所述装置包括剂量调拨套筒和内壳体部分。所述剂量调拨套筒联接到所述内壳体。在该示例性布置中,所述剂量调拨套筒在所述药物输送装置的填装期间在圆周旋转路径上旋转。此外,所述剂量调拨套筒在所述药物输送装置的剂量设定期间在螺旋路径上旋转。
所述内壳体(部分)可以包括螺纹或花键部分,具有旋转螺纹(花键)部分和螺旋螺纹(花键)部分。所述旋转螺纹(花键)部分限定所述圆周路径并且所述螺旋螺纹(花键)部分限定所述螺旋路径。因此,所述调拨套筒在所述药物输送装置的填装期间在所述旋转螺纹部分上旋转,并且所述调拨套筒在所述药物输送装置的剂量设定期间沿着所述螺旋螺纹部分平移。
根据优选实施例,在所述药物输送装置的填装之前防止所述调拨套筒在所述螺旋路径上旋转。换句话说,所述调拨套筒只能在所述剂量调拨套筒在所述圆周路径上旋转的填装步骤已完成之后在所述螺旋路径上旋转。
根据本发明的另一个方面,所述剂量设定机构还包括布置在所述调拨套筒上的至少一个止回元件。优选的是除了所述止回元件之外提供布置在所述内壳体部分上的至少一个互补止回元件,所述至少一个互补止回元件与布置在所述调拨套筒上的所述至少一个止回元件互补。所述止回元件可以是从所述调拨套筒的凸起,所述互补止回元件是从所述内壳体的凸起。优选地,所述止回元件连接到所述调拨套筒的挠性元件部分。因此,所述挠性元件允许所述止回元件在旋转运动期间越过所述互补止回元件,并且在大致旋转路径的端部,所述挠性元件操作以防止所述止回元件向后越过所述互补止回元件。
如果大致旋转路径包括旋转路径的端部,则当所述调拨套筒大致到达旋转路径的端部时,所述至少一个止回元件和所述至少一个互补止回元件相互作用以防止所述调拨套筒沿着旋转路径向后的大致运动。
根据本发明的另一个实施例,所述剂量设定机构联接到筒壳体。这可以通过使用不可逆联接件实现。换句话说,所述剂量设定机构和所述筒壳体可以形成用后可弃单元,即,所述药物输送装置是不可再使用的。然而,作为备选,所述药物输送装置可以被构造和设计成形成可再使用装置。
优选的是向用户指示所述装置是否已填装。为此所述调拨套筒可以包括图形,所述图形在填装之前显示并且在填装之后不显示。因此,所述图形指示所述药物输送装置还未填装。
根据另一个布置,提供了一种填装药物输送装置的方法。所述方法包括提供剂量调拨套筒,所述剂量调拨套筒与药物输送装置的内壳体接合。所述方法也包括在围绕所述内壳体的圆周旋转路径上旋转所述剂量调拨套筒。在该示例性布置中,旋转所述剂量调拨套筒填装所述药物输送装置。
通过适当地参考附图阅读以下详细描述,本领域的普通技术人员将显而易见本发明的各个方面的这些以及其它优点。
附图说明
在本文中参考附图描述示例性实施例,其中:
图1示出了根据本发明的一个方面的药物输送装置的布置;
图2示出了图1的药物输送装置,其中帽被去除并且显示了筒保持器;
图3示出了示例性剂量设定机构(例如图2中所示的剂量设定机构)的横截面图;
图4示出了剂量设定机构(例如图3的剂量设定机构的内壳体部分)的透视图;
图5示出了剂量设定机构(例如图3的剂量设定机构的剂量调拨套筒)的透视图;
图6示出了在填装剂量设定机构(例如图3中所示的剂量设定机构)之前联接到内壳体的剂量调拨套筒的透视图;
图7示出了在填装剂量设定机构(例如图3中所示的剂量设定机构)之后联接到内壳体的剂量调拨套筒的透视图;以及
图8示出了在填装剂量设定机构(例如图3中所示的剂量设定机构)期间联接到内壳体的剂量调拨套筒的透视图。
具体实施方式
术语“药物”如用于本文,优选意指含有至少一种药学活性化合物的药物制剂,在一个实施方案中,其中所述药学活性化合物具有高至1500Da的分子量并且/或者是肽、蛋白质、多糖、疫苗、DNA、RNA、抗体、酶、抗体、激素或寡核苷酸,或上述药学活性化合物的混合物。
在另一实施方案中,所述药物活性化合物可用于治疗和/或预防糖尿病或与糖尿病相关的并发症,如糖尿病视网膜病变、血栓栓塞病症如深静脉或肺血栓栓塞、急性冠状动脉综合征(ACS)、心绞痛(angina)、心肌梗死、癌症、黄斑变性、炎症、枯草热、动脉粥样硬化和/或类风湿性关节炎。
在另一实施方案中,所述药物活性化合物包含至少一种用于治疗和/或预防糖尿病或与糖尿病相关的并发症如糖尿病视网膜病变的药物活性化合物。
在另一实施方案中,所述药物活性化合物包含至少一种人胰岛素或人胰岛素类似物或衍生物,胰高血糖素样肽(GLP-1)或其类似物或衍生物,或Exedin-3或Exedin-4,或Exedin-3或Exedin-4的类似物或衍生物。
胰岛素类似物举例而言是Gly(A21)、Arg(B31)、Arg(B32)人胰岛素;Lys(B3),Glu(B29)人胰岛素;Lys(B28)、Pro(B29)人胰岛素;Asp(B28)人胰岛素;人胰岛素,其中B28位的脯氨酸由Asp、Lys、Leu、Val或Ala替代,并且其中B29位的Lys可以由Pro替代;Ala(B26)人胰岛素;Des(B28-B30)人胰岛素;Des(B27)人胰岛素和Des(B30)人胰岛素。
胰岛素衍生物举例而言是B29-N-肉豆蔻酰-des(B30)人胰岛素;B29-N-棕榈酰-des(B30)人胰岛素;B29-N-肉豆蔻酰人胰岛素;B29-N-棕榈酰人胰岛素;B28-N-肉豆蔻酰LysB28ProB29人胰岛素;B28-N-棕榈酰-LysB28ProB29人胰岛素;B30-N-肉豆蔻酰-ThrB29LysB30人胰岛素;B30-N-棕榈酰-ThrB29LysB30人胰岛素;B29-N-(N-棕榈酰-Y-谷氨酰)-des(B30)人胰岛素;B29-N-(N-石胆酰-Y-谷氨酰)-des(B30)人胰岛素;B29-N-(ω-羧基十七烷酰)-des(B30)人胰岛素和B29-N-(ω-羧基十七烷酰)人胰岛素。
Exendin-4举例而言意指Exendin-4(1-39),一种序列为H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2的肽。
Exendin-4衍生物举例而言选自下列化合物:
H-(Lys)4-des Pro36,des Pro37 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36,des Pro37 Exendin-4(1-39)-NH2,
des Pro36[Asp28]Exendin-4(1-39),
des Pro36[IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]Exendin-4(1-39);或
des Pro36[Asp28]Exendin-4(1-39),
des Pro36[IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14,IsoAsp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Trp(O2)25,IsoAsp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,Asp28]Exendin-4(1-39),
des Pro36[Met(O)14Trp(O2)25,IsoAsp28]Exendin-4(1-39),
其中所述基团-Lys6-NH2可以结合至Exendin-4衍生物的C-端;
或具有如下序列的Exendin-4衍生物
H-(Lys)6-des Pro36[Asp28]Exendin-4(1-39)-Lys6-NH2,
des Asp28Pro36,Pro37,Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro38[Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36[Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2,
H-des Asp28Pro36,Pro37,Pro38[Trp(O2)25]Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36[Met(O)14,Asp28]Exendin-4(1-39)-Lys6-NH2
des Met(O)14Asp28Pro36,Pro37,Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-(Lys)6-NH2,
H-Lys6-des Pro36[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25]Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Asp28]Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-NH2,
des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendm-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(S1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Met(O)14,Trp(O2)25,Asp28]Exendin-4(1-39)-(Lys)6-NH2;
或前述Exedin-4衍生物中任一种的药学上可接受的盐或溶剂合物。
激素举例而言是垂体激素或丘脑激素或调节性活性肽及其拮抗剂,如Rote Liste编辑,2008,第50章中所列,如***(Gonadotropine)(促卵泡激素(Follitropin)、促黄体素(Lutropin)、绒毛膜***(Choriongonadotropin)、促配子成熟激素(Menotropin)),生长激素(Somatropine)(促生长素(Somatropin)),去氨加压素(Desmopressin),特利加压素(Terlipressin),戈那瑞林(Gonadorelin),曲普瑞林(Triptorelin),亮丙瑞林(Leuprorelin),布舍瑞林(Buserelin),那法瑞林(Nafarelin),戈舍瑞林(Goserelin)。
多糖举例而言是葡糖胺聚糖、透明质酸、肝素、低分子量肝素或超低分子量肝素或它们的衍生物,或上述多糖的硫酸化形式,例如,多聚硫酸化形式,和/或它们药学上可接受的盐。多聚硫酸化低分子量肝素的药学上可接受的盐的实例是依诺肝素钠(enoxaparin sodium)。
药学上可接受的盐举例而言是酸加成盐和碱式盐。酸加成盐是例如HCl或HBr的盐。碱式盐是例如具有选自碱或碱性物质(alkali or alkaline)的阳离子的盐,所述阳离子例如Na+,或K+,或Ca2+,或铵离子N+(R1)(R2)(R3)(R4),其中R1至R4彼此独立地意指:氢,任选地取代的C1-C6-烷基,任选地取代的C2-C6-烯基,任选地取代的C6-C10-芳基,或任选地取代的C6-C10-杂芳基。药学上可接受的盐的其他实例在″Remington′s Pharmaceutical Sciences″17.编辑Alfonso R.Gennaro(Ed.),Mark Publishing Company,Easton,Pa.,U.S.A.,1985中和Encyclopedia of Pharmaceutical Technology中描述。
药学上可接受的溶剂合物举例而言是氢氧化物。
参考图1,显示了根据示例性布置的药物输送装置1。药物输送装置1包括壳体,所述壳体具有第一筒保持部分2和剂量设定机构4。药物输送装置可以是可重设药物输送装置(即,可再使用装置)或可替代地是不可重设药物输送装置(即,不可再使用装置)。筒保持部分2的第一端部和剂量设定机构4的第二端部由连接特征固定在一起。对于不可重设装置,这些连接特征将是永久的和不可逆的。对于可重设装置,这些连接特征将是可释放的。
在该所示的布置中,筒壳体2固定在剂量设定机构4的第二端部内。可去除帽3可释放地保持在筒保持部分或筒壳体的第二端部或远端上。剂量设定机构4包括剂量调拨把手12和窗口或透镜14。剂量标度布置16通过窗口或透镜14可视。为了设定包含在药物输送装置1内的药剂的剂量,用户旋转剂量调拨把手12,使得调拨剂量将通过剂量标度布置16在窗口或透镜14中变得可视。
图2示出了图1的药物输送装置1,其中盖3从药物输送装置1的远端19去除。该去除暴露筒壳体6。如图所示,可以从其分配药品的多个剂量的筒25设在筒壳体6中。优选地,筒25包含可以相对频繁地被施予类型的药剂,例如每天一次或多次。一种这样的药剂是长效或短效胰岛素或胰岛素类似物。筒25包括保持在筒25的第二端部或近端33附近的塞子或封堵器(未在图2中示出)。药物输送装置也包括具有心轴的驱动器(未在图2中示出)。如上所述,在填装装置之前,在心轴的端部和筒塞之间可能有或没有间隙。
筒壳体6具有远端23和近端27。优选地,筒壳体6的筒远端23包括用于附连可去除针组件的凹槽8。然而,也可以使用其它针组件连接机构。如果药物输送装置1包括可重设装置,则筒近端27可去除地连接到剂量设定机构4。在一个优选实施例中,筒壳体近端27经由卡口连接可去除地连接到剂量设定机构4。然而,本领域的普通技术人员将认识到,也可以使用其它类型的可去除连接方法,例如螺纹、部分螺纹、斜坡和棘爪(ramps and detents)、卡锁、卡扣配合和路厄锁。
如先前所述,图2中所示的药物输送装置的剂量设定机构4可以用作可再使用药物输送装置(即,可以重设的药物输送装置)。在药物输送装置1包括可再使用药物输送装置的情况下,筒25从筒壳体6可去除。通过仅仅让用户将剂量设定机构4从筒壳体6断连,筒25可以从装置1去除而不破坏装置1。
在使用中,一旦帽3被去除,用户可以将合适的针组件附连到设在筒壳体6的远端23的凹槽8。这样的针组件例如可以拧接到壳体6的远端23上或者可替代地可以卡扣到该远端23上。在使用之后,可更换帽3可以用于再覆盖筒壳体6。优选地,可更换帽3的外部尺寸与剂量设定机构4的外部尺寸相似或相同,从而在装置未使用时,当可更换帽3处于覆盖筒壳体6的位置时提供整体的印象。
图3示出了用后可弃剂量设定机构50(例如图2中所示的剂量设定机构4)的第一布置的横截面图。参考图3,剂量设定机构50包括剂量调拨把手52、弹簧51、外壳体54、离合器55、驱动器53、调拨套筒56、心轴64和内壳体58。驱动器53可以包括可操作地联接到心轴64的远侧部分57和近侧部分59。在正常使用中,剂量设定机构50的操作如下进行。为了调拨剂量,用户旋转剂量调拨把手52。驱动器53、离合器55和调拨套筒56与剂量调拨把手一起旋转。
调拨套筒56在近侧方向上远离内壳体58延伸。以该方式,驱动器53沿着心轴64爬升。在行程的极限,调拨套筒56上的径向限位件接合设在外壳体54上的第一限位件或第二限位件以防止进一步移动。由于心轴上的检修和驱动螺纹的相反方向而防止心轴的旋转。键连到外壳体54的剂量限制器68由驱动器53的旋转沿着螺纹推进。在施予预定量的药物之后,剂量限制器68邻接并且停止于设在驱动器53的远侧部分57上的凸缘处。
当已调拨期望剂量时,用户然后可以通过下压调拨把手52分配期望剂量。当用户下压调拨把手52时,这使离合器55相对于调拨套筒56轴向地移位,导致离合器55脱离。然而离合器55保持旋转键连到驱动器53。
驱动器53被防止相对于外壳体54旋转,但是它相对于外壳体自由地轴向移动。驱动器53的纵向轴向运动导致心轴旋转并且由此推进筒中的活塞。
根据示例性布置,可能有利的是在用户调拨并且注射第一剂量之前强制用户填装图1和2的药物输送装置。为了实现该强制填装,如下面将更详细地所述,药物输送装置1的剂量设定机构4优选地强制用户在设定第一剂量之前填装装置。
如上所述,剂量设定机构50包括彼此相互作用以强制用户在调拨第一剂量之前填装装置的内壳体58和调拨套筒56。图4示出了内壳体70(例如图3中所示的剂量设定机构50的内壳体58)的一个布置。内壳体70包括螺纹部分72。螺纹部分72包括旋转螺纹部分74和螺旋螺纹部分76。旋转螺纹部分74可以由相对面78和80限定。旋转螺纹部分限定旋转路径并且螺旋螺纹部分限定螺旋路径。如下面将更详细地所述,沿着旋转路径的运动操作以填装药物输送装置,使得心轴64(如图3中所示)移动到邻接筒的塞子的位置。另外,沿着螺旋路径的运动操作以设定剂量设定机构(例如图3中所示)的剂量。
内壳体70还包括至少一个止回元件82。止回元件82可以是从内壳体70的凸起,并且凸起可以是各种形状。例如,止回元件82可以是升高的大致矩形凸起。然而应当理解,止回元件82可以是不同形状。在示例性布置中,内壳体70也包括两个止回元件。然而,内壳体70可以具有任何数量的止回元件。止回元件可以位于内壳体70的远端或沿着它的长度的任何位置。
图5示出了调拨套筒84(例如图3中所示的调拨套筒56)的布置。当组装时,调拨套筒84置于内壳体70之上并且与内壳体70接合。如上所述,调拨套筒84可以带有标度布置16。调拨套筒84也包括螺纹部分86。螺纹部分86优选地是内螺纹部分,如图所示。内螺纹部分86能够与内壳体70的螺纹部分72接合。特别地,内螺纹部分能够与旋转螺纹部分74和螺旋螺纹部分76两者接合。
调拨套筒84还包括至少一个止回元件88。在示例性布置中,内壳体70上的止回元件82与调拨套筒84上的止回元件88互补。止回元件可以是从剂量调拨套筒的凸起。在示例性布置中,止回元件88连接到调拨套筒84的挠性元件90。如图所示,挠性元件90可以由调拨套筒84中的狭缝产生。然而应当理解挠性元件可以以不同方式形成。例如,剂量调拨套筒可以由挠性材料制造。如下面将更详细地所述,当调拨套筒行进通过由旋转螺纹部分限定的旋转路径时,挠性元件90优选地允许止回元件88越过内壳体70的互补止回元件82。
当剂量调拨套筒84和内壳体70接合时,这些元件用作在用户可以设定第一剂量之前强制用户填装装置的剂量设定机构。特别地,在调拨套筒可以沿着螺旋螺纹部分76行进之前,调拨套筒84必须在沿着旋转螺纹部分74的路径上行进。当该剂量设定机构强制用户填装装置时,所述的剂量设定机构没有由于心轴64和筒塞之间的初始分离而可能分配错误剂量的缺陷。
将参考图6-8进一步描述剂量设定机构的操作。图6示出了填装药物输送装置之前的剂量设定机构。如图所示,调拨套筒84的内螺纹86与内壳体70的旋转螺纹部分74接合。用户必须首先沿着大致旋转的路径旋转调拨套筒84。在旋转运动期间,调拨套筒沿着圆周或圆形路径旋转。该运动被限制为大致旋转的运动,并且调拨套筒不会轴向地移动越过内壳体70(即,调拨套筒不平移)。
该圆周旋转运动用于填装药物输送装置。如图3中所示的示例性剂量设定机构中所示,药物输送装置1(或更特别地,剂量设定机构50)可以包括驱动器53和心轴64。剂量调拨套筒84可以联接到驱动器。此外,如参考图1所述,药物输送装置可以包括容纳筒的筒壳体,可以从所述筒分配药品的多个剂量。该筒壳体可以联接到剂量设定机构50。剂量调拨套筒84沿着旋转螺纹部分的运动也可以导致驱动器旋转。驱动器的该旋转可以导致心轴朝着筒壳体中的筒前进。心轴的该前进消除心轴和筒塞之间的任何可能的初始分离。换句话说,由剂量调拨套筒和驱动器的旋转导致的心轴的该前进填装药物输送装置。尽管如图所示示例性剂量设定机构50是用后可弃剂量设定机构,但是本领域的技术人员将认识到这样的剂量设定机构可以进行修改以用作可再使用或可重设剂量设定机构。
如果在用户填装装置之前用户将针附连到药物输送装置1,则少量药物可能在填装操作期间被排出。可替代地,如果用户在填装装置之后或在设定第一剂量之后附连针,则当针连接到药物输送装置时将从填装被加压的药物将被排出。因此,在针***用户的皮肤中之前由填装操作产生的药物量将被排出。
图7示出了药物输送装置的填装发生之后的剂量设定机构。如图所示,内壳体70的旋转螺纹部分74限定大致旋转路径,当剂量调拨套筒上的内螺纹86与内壳体上的螺旋螺纹76的起点相接触时,所述大致旋转路径终止。当剂量调拨套筒到达旋转路径的端部或旋转路径的大致端部时,内壳体的止回元件82和调拨套筒的止回元件88相互作用以防止沿着旋转路径朝着原始起点位置的大致向后运动。特别地,止回元件88防止剂量调拨套筒向后旋转经过止回元件82。换句话说,在药物输送装置的填装期间止回元件相互作用以防止沿着剂量调拨套筒所行进的旋转路径的部分移动。
通过比较图6和7可以看出,在填装操作(即,调拨套筒的旋转运动)期间,调拨套筒的止回元件88能够在内壳体的止回元件82之上行进。另外,调拨套筒的挠性元件90允许止回元件88越过止回元件90。然而,在旋转路径的端部并且在止回元件彼此经过之后,挠性元件朝着内壳体向下卡扣,如图7中所示。当挠性元件向下卡扣时,在装置的填装期间止回元件82和88彼此邻接并且防止剂量调拨套筒在它所行进的旋转路径上返回。
在填装之后,如果装置的用户试图在旋转路径上移动剂量调拨套筒,则该运动被防止,原因是剂量调拨套筒上的止回元件88将不克服内壳体上的止回元件82。
图8示出了药物输送装置的剂量设定期间的剂量设定机构。图8显示了剂量设定机构,其中大约两个单位已被调拨。可以看到,当正在调拨剂量时,调拨套筒的内螺纹86与内壳体的螺旋螺纹部分76接合。药物输送装置被设计成使得在剂量设定期间,剂量调拨套筒在由螺旋螺纹部分限定的螺旋路径上行进。剂量调拨套筒不能接合该螺旋螺纹,直到剂量调拨套筒已沿着内壳体的旋转螺纹旋转。因此,用户不能调拨第一剂量,直到用户已填装装置。
在示例性布置中,药物输送装置可以被设计成向用户指示在调拨剂量之前装置需要被填装还是不需要被填装。例如,剂量调拨套筒3可以包括印刷在其上的图形,在笔被填装之前所述图形显示在剂量窗口14中。该图形可以显示字符(例如“P”)或短语(例如“需要填装”)。其它图形也是可能的。一旦装置已被填装,该图形将不再显示在剂量窗口中。
此外,由于在填装之后止回元件防止剂量调拨套筒在旋转路径上返回,因此用户不必在每个后续剂量之前填装装置。因此,根据示例性实施例的剂量设定机构强制用户在调拨第一剂量之前填装装置,但是不强制用户为后续剂量填装装置。然而,在药物输送装置可再使用的情况下,应当理解,根据示例性实施例的剂量设定机构被设计成使得每当更换筒时剂量设定机构强制用户填装装置。在这样的可再使用装置中,装置优选地被设计成使得用户可以克服止回元件。这可以例如通过在处于调拨位置的棘爪之上旋转剂量调拨套筒而实现。该旋转将沿着旋转路径向后旋转数字套筒。用于克服止回元件的其它方式也是可能的。此外,在该示例性实施例中,可能有利的是强制用户在能够去除筒保持器之前这样做。
已描述了本发明的示例性实施例。然而本领域的技术人员将理解可以对这些实施例进行变化和修改而不脱离由权利要求限定的本发明的真实范围和精神。
Claims (15)
1.一种用于药物输送装置的剂量设定机构,包括剂量调拨套筒(56、84)和内壳体部分(58、70),
其中所述调拨套筒(56、84)联接到所述内壳体(58、70),
其中所述调拨套筒(56、84)在所述药物输送装置的填装期间沿着大致旋转路径(74)旋转,并且
其中所述调拨套筒(56、84)在所述药物输送装置的剂量设定期间沿着螺旋路径(76)平移。
2.根据权利要求1所述的剂量设定机构,其中所述内壳体(58、70)包括螺纹部分(72),并且其中所述螺纹部分包括旋转螺纹部分(74)和螺旋螺纹部分(76)。
3.根据权利要求1或2所述的剂量设定机构,其中在所述药物输送装置的填装之前,防止所述调拨套筒(56、84)在所述螺旋路径(76)上旋转。
4.根据前述权利要求1中的任一项所述的剂量设定机构,还包括布置在所述调拨套筒(56、84)上的至少一个止回元件(88)和布置在所述内壳体(58、70)上的至少一个互补止回元件(82),所述至少一个互补止回元件与布置在所述调拨套筒(56、84)上的所述至少一个止回元件(88)互补。
5.根据权利要求4所述的剂量设定机构,其中所述大致旋转路径(74)包括所述旋转路径的端部,其中当所述调拨套筒(56、84)大致到达所述旋转路径(74)的端部时,所述至少一个止回元件(88)和所述至少一个互补止回元件(82)相互作用以防止所述调拨套筒(56、84)沿着所述旋转路径(74)向后的大致运动。
6.根据权利要求4或5所述的剂量设定机构,其中所述止回元件(88)是从所述调拨套筒(56、84)突出的凸起,并且其中所述互补止回元件(82)是从所述内壳体(58、70)突出的凸起。
7.根据权利要求6所述的剂量设定机构,其中所述止回元件(88)连接到所述调拨套筒(56、84)的挠性元件部分(90),其中所述挠性元件(90)允许所述止回元件(88)在旋转运动期间越过所述互补止回元件(82),并且其中在所述大致旋转路径(74)的端部,所述挠性元件(90)进行操作以防止所述止回元件(88)向后越过所述互补止回元件(82)。
8.根据前述权利要求中的任一项所述的剂量设定机构,其中所述剂量设定机构经由不可逆联接件联接到筒壳体(6)。
9.根据前述权利要求中的任一项所述的剂量设定机构,其中所述调拨套筒(58、70)包括图形,所述图形在填装之前显示,并且其中所述图形指示所述药物输送装置还未填装。
10.根据前述权利要求中的任一项所述的剂量设定机构,其中所述剂量设定机构还包括:
驱动器(53);以及
心轴(64),其中所述调拨套筒(56、84)可操作地联接到所述驱动器(53),使得所述调拨套筒(56、84)的旋转导致所述驱动器(53)旋转并且导致所述心轴(64)在远侧方向上平移,该平移填装所述药物输送装置。
11.根据前述权利要求中的任一项所述的剂量设定机构,尤其对于可再使用药物输送装置,还包括:
布置在所述剂量调拨套筒(56、84)上的至少一个止回元件(88);
布置在所述内壳体(58)上的至少一个互补止回元件(82),所述至少一个互补止回元件与布置在所述剂量调拨套筒(56、84)上的所述至少一个止回元件(88)互补,
其中当用户正在设定剂量时,所述止回元件(88)和所述互补止回元件(82)防止沿着大致圆周旋转路径(74)的大致旋转运动,并且
其中当用户未正在设定剂量时,所述止回元件(88)和所述互补止回元件(82)能够由所述装置的用户克服。
12.一种填装药物输送装置的方法,所述方法包括:
提供剂量调拨套筒(56、84),所述剂量调拨套筒与药物输送装置的内壳体(58、70)接合;
在围绕所述内壳体(58、70)的大致圆周旋转路径(74)上旋转所述剂量调拨套筒(56、84),其中旋转所述剂量调拨套筒(56、84)填装所述药物输送装置。
13.根据权利要求12所述的方法,还包括:
响应所述药物输送装置的填装,防止所述剂量调拨套筒(56、84)圆周地旋转。
14.根据权利要求13所述的方法,其中防止所述剂量调拨套筒(56、84)圆周地旋转包括将止回特征(88)设在所述剂量调拨套筒(56、84)上,所述止回特征与所述内壳体(58、70)上的相应止回特征(82)相互作用。
15.根据权利要求14所述的方法,还包括:
将大致圆周旋转螺纹(74)设在所述内壳体(58、70)上,其中在围绕所述内壳体(58、70)的所述大致圆周旋转路径(74)上旋转所述剂量调拨套筒(56、84)包括沿着所述大致圆周旋转螺纹(74)旋转所述剂量调拨套筒(56、84)。
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CN105102026A (zh) * | 2013-04-10 | 2015-11-25 | 赛诺菲 | 注射装置 |
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Also Published As
Publication number | Publication date |
---|---|
AU2010255806B2 (en) | 2014-12-18 |
IL216480A0 (en) | 2012-01-31 |
JP5820808B2 (ja) | 2015-11-24 |
DK2437824T3 (en) | 2019-01-28 |
JP2012528620A (ja) | 2012-11-15 |
AU2010255806A1 (en) | 2011-12-22 |
US9408978B2 (en) | 2016-08-09 |
US20100324528A1 (en) | 2010-12-23 |
WO2010139631A1 (en) | 2010-12-09 |
BRPI1014727A2 (pt) | 2016-04-12 |
EP2437824A1 (en) | 2012-04-11 |
US20130218130A1 (en) | 2013-08-22 |
EP2437824B1 (en) | 2018-10-03 |
US20120172813A1 (en) | 2012-07-05 |
CA2762414A1 (en) | 2010-12-09 |
US8585656B2 (en) | 2013-11-19 |
US10279116B2 (en) | 2019-05-07 |
CN102458529B (zh) | 2014-11-05 |
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