CN105228676A - 包括具有内联干燥药物组件的小瓶转接器的医疗装置 - Google Patents
包括具有内联干燥药物组件的小瓶转接器的医疗装置 Download PDFInfo
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Abstract
医疗装置,该医疗装置包括具有内联干燥药物组件(33)的小瓶转接器,内联干燥药物组件(33)与小瓶、无针注射器和载液一起使用,用于使得无针注射器填充有注射液用来向患者注射。内联干燥药物组件(33)包括用于储存干燥药物剂量的干燥药物储存构件(57)和均匀载液分布构件(58),均匀载液分布构件(58)用于促进载液均匀接触干燥药物储存构件以形成来自干燥药物剂量的注射液。该内联干燥药物组件可包括分离的干燥药物储存构件和分离的均匀载液分布构件或用于药物储存和均匀载液分布的双重目的构件。该小瓶转接器可以通气式或非通气式形式被提供。
Description
技术领域
本发明涉及具有内联干燥药物组件的医疗装置,其包括与液体源一起使用的干燥药物剂量用于向患者肠道外投予。
背景技术
医学治疗通常涉及向人体肠道外投予液体药物。液体药物可呈溶液、悬浮剂等形式。一些药物试剂在干燥状态具有延长的储存期,在重构或再水化后仅仅具有短的储存期。
美国专利号6,520,932(Taylor)公开了内联药物递送包(35),内联药物递送包(35)内联连接静脉注射(IV)管(intravenous(IV)line)并且允许稀释剂和待递送给患者的药物试剂的混合。该药物递送包包括具有试剂床(110)的外壳(37),试剂床(110)由适合通过溶解和静脉滴注向患者投予的液体可溶的材料构成。该外壳包括入口径向鳍状物(65),入口径向鳍状物(65)与来自入口端筛板(inletfrit)(80)的背压配合以促进稀释剂横跨药物递送包的整个横截面的均匀分布。当干燥的试剂被溶解时,内部药物床旁路机械装置(internaldrugbedbypassmechanism)被调整以分配旁路和药物床之间的稀释剂液流以获得适合于静脉投予的溶液浓度。
美国专利号6,951,613(Reif等)公开了基因接种疫苗装置以及为此形成注射液的方法。该装置包括注射器(2)和被连接到内联膜吸附器(5)上的套管(3),内联膜吸附器(5)具有在其上被吸附的基因材料。该方法包括从膜吸附器上洗脱基因材料以形成含有基因材料的注射液。
美国专利申请公开号US2008/0294100(deCosta等)公开了用于向患者投予基质的药物装置。该deCosta药物装置类似于上述的Reif基因接种疫苗装置,不同之处在于它包括内联多孔膜,该内联多孔膜负载在水中可溶的玻璃质材料并且具有稳定在其上的比如疫苗的生物材料使得当生物材料需要投予时,洗脱液可以横穿膜,溶解玻璃质物并且使得物质通过液体被携带入患者。
Reif基因接种疫苗装置和deCosta药物装置是相对笨重并且在向患者注射注射液期间操作麻烦。再者,它们的含有向患者注射的干燥药物剂量的装置外壳必然以比通常的注射角度更大的角度向患者身体进行注射。
需要医疗装置,该医疗装置具有内联干燥药物组件用于容易向患者注射注射液。
发明内容
本发明针对的是包括具有内联干燥药物组件的小瓶转接器的医疗装置,该内联干燥药物组件具有干燥药物剂量用于与无针注射器和小瓶一起使用,用于使得无针注射器填充有由干燥的药物剂量组成的注射液用于向患者投予。该医疗装置优选地与初始地空无针注射器和初始地填充有液态载剂(liquidcarrier)的小瓶一起使用。或者,该医疗装置可用于与初始地预填充有液态载剂的注射器和初始地空瓶一起使用。该液态载剂可以仅仅是稀释剂,或者可包括活性成分。
该小瓶转接器具有类似于市场上可获得的通气式或非通气式小瓶转接器的构造,除了内联干燥药物组件之外。该内联干燥药物组件包括用于储存干燥药物剂量的干燥药物储存构件和均匀载液分布构件,该均匀载液分布构件用于促进该载液均匀接触干燥药物储存构件以形成注射液。该干燥药物储存构件和该均匀载液分布构件可以是两个分离的构件。或者,该两个构件可以单一的双重目的构件(singledualpurposecomponent)被组合。
该内联干燥药物组件可利用数个市场上可获得的技术中任何一种用于实现长期储存干燥药物剂量用来随后接触载液形成注射液。合适的市场上可获得的技术尤其在背景技术中承认的现有技术参考文献中被讨论了。不同的技术尤其包括使载液流过多孔基质以溶解或带走干燥药物剂量,使载液在基质表面上流动以溶解或带走干燥药物剂量等。
本发明的医疗装置与初始地空无针注射器和初始地填充的小瓶一起使用涉及单一吸入。或者,本发明的医疗装置与初始地填充的注射器和初始地空瓶一起使用需要从注射器初始地注射载液到小瓶并且随后地从小瓶吸入到注射器。至于完全使用干燥药物剂量,前者使用需要较少的时间而后者使用能提供较大的确定性。
本发明的医疗装置对准备无针注射器用来向患者注射注射液提供了方便的低成本方案。本发明的医疗装置尤其适用于与所谓的热稳定的药物和试剂一起使用,该热稳定的药物和试剂在周围环境温度下具有相对长的储存期,从而无需冷藏。合适的药物和试剂尤其包括疫苗等。
附图说明
为了理解本发明并且理解在实践中如何实施它,参考附图,仅仅借助于非限制性实施例,优选的实施例将被描述,其中相同的部分做了同样的编号,其中:
图1是初始地空无针注射器、小瓶和根据本发明第一实施例的用于使初始地空的无针注射器填充有注射液的通气式医疗装置的图示;
图2是图1中医疗装置的底部透视图;
图3是图1中医疗装置的侧视图;
图4是图1中医疗装置沿图3中A-A线的纵向截面图;
图5是图1中医疗装置的分解图;
图6是图1中医疗装置的均匀载液分布构件的底部透视图;
图7A显示了在将载液从小瓶吸入到无针注射器之前,初始地空无针注射器、图1医疗装置和小瓶的倒置的组合件;
图7B显示了载液从小瓶部分吸入到无针注射器之后倒置的组合件;
图7C显示了填充有注射液的无针注射器用于向患者投予的倒置的组合件;
图8是图7B的组合件的环形部分的近距离纵向截面图,显示了在吸入期间,载液从小瓶流向注射器;
图9是根据本发明第二实施例的通气式医疗装置的分解图;以及
图10是图9医疗装置的均匀载液分布构件的底部透视图。
附图的详细描述
图1显示了空无针注射器10、小瓶20和通气式医疗装置30,用于使得无针注射器10填充有注射液用于向患者投予。注射器10包括具有柱塞杆12和注射器端13的活塞筒11。小瓶20包括由小瓶瓶塞22密封的小瓶瓶体21。小瓶瓶体21通常包括用于固定小瓶瓶体21上的小瓶瓶塞22的铝密封条23。小瓶瓶体21具有含有载液26的小瓶内部24。载液26可以仅仅是稀释剂。或者,载液26可包括活性成分。
图1到6显示了医疗装置30具有纵向的装置中心线31并且包括具有内联干燥药物组件33的小瓶转接器32。小瓶转接器32包括裙34,裙34具有横向的顶部裙壁36和向下悬垂的弯曲部件37用于伸缩地安装到小瓶20上。顶部裙壁36与中心的裙毂(centralskirthub)38一起形成,裙毂与纵向的装置轴31同轴,具有6个平均间隔的从其向外延伸的径向肋状物39。中心的裙毂38同与纵向装置轴31同轴的液体转移端口41和相对于纵向装置轴31偏移的通气端口42一起形成。
小瓶转接器32包括顶盖43,顶盖43具有中心的直立的母连接头44,其与纵向的装置中心线31同轴,用于与注射器端13的密封连接。注射器端13优选是公鲁尔锁接头,中心的直立的母连接头44是母鲁尔锁接头用于螺纹安装无针注射器10到医疗装置30上。或者,注射器端13与母连接头44可以与其它连接头一起形成。
小瓶转接器32包括向下悬垂的穿刺套管46,其与纵向的装置31同轴用于当伸缩地安装医疗装置30到小瓶20上时刺穿小瓶瓶塞22用于与小瓶内部24的流体连通。套管46包括与液体转移端口41流体连通的液体转移腔47和与通气端口42流体连通的通气腔48。
小瓶转接器32包括用于在顶盖43和顶部裙壁36之间部署的过滤器盖49。过滤器盖49包住放置在径向肋状物39上的空气过滤器51。空气过滤器51具有与纵向的装置轴31同轴的中心的空气过滤器孔52。过滤器盖49包括与纵向的装置轴31同轴的中心的过滤器盖孔53和与多个通气孔56一起形成的外围的过滤器盖边缘54。
内联干燥药物组件33被内联地设置在中心的直立的母连接头44和穿刺套管46,具体地说液体转移端口41,之间。内联干燥药物组件33包括干燥药物储存构件57,其接近直立的母连接头44并且远离穿刺套管46。内联干燥药物组件33进一步包括均匀载液分布构件58,其接近穿刺套管46并且远离直立的母连接头44。
干燥药物储存构件57优选形成为圆盘样的基质,其由广泛的合适的生物相容的惰性多孔材料构成,使得载液26从中流动。合适的材料尤其包括玻璃纤维、塑料纤维等。干燥药物储存构件57被提供有干燥药物剂量59用于向患者投予。干燥药物剂量59可呈极细的颗粒形式等,用于当携带载液26通过干燥药物储存构件57时实现注射液的重构。
均匀载液分布构件58优选地形成为圆盘样部件,其具有朝向直立的母连接头44的均匀载液分布构件顶侧58A、朝向穿刺套管46的均匀载液分布构件下侧58B和均匀载液分布构件外围边缘61。均匀载剂分布构件下侧58B与一系列径向的沟槽62一起形成,各自终止在均匀载液分布构件外围边缘61中的开口(cutout)63中,用于实现从均匀载液分布构件下侧58B到均匀载液分布构件顶侧58A的流体连通。
现在参考图7A到7C和图8,描述了医疗装置30的使用,其用于准备具有用于向个体注射的注射液的无针注射器10,其中图8是图7B中A所示的圆形区域的放大图。
图7A显示了使用者伸缩地安装医疗装置30到小瓶20上以刺穿小瓶瓶塞22。使用者连接无针注射器10到母连接头44上。使用者倒置组合件使得小瓶20在无针注射器10以上并且开始从小瓶20吸入载液26到无针注射器10中。
图7B和图8显示载液26从小瓶20流到初始地空无针注射器10,如下所示:载液26沿着液体转移腔47向下流到均匀载液分布构件下侧58B。载液26沿着径向的沟槽62从均匀载液分布构件下侧58B的中心向外径向地流动到均匀载液分布构件外围边缘61。
载液26向下流动通过开口63并且接着径向地向内通过多孔的干燥药物储存构件57以随其带走干燥药物剂量59以形成注射液64。在载液26从小瓶20吸入到注射器10期间,空气被吸进通过通气孔56、空气过滤器51和通气腔48进入小瓶20中,如载液26中的气泡所示。
图7C显示了填充有注射液64的注射器10在从母连接头44分离并且连接针头之后,准备用于向个体注射。
图9显示了构造和操作上类似于通气式医疗装置30的通气式医疗装置70,因此,相同的部件被做了同样的编号。后者70不同于前者30之处在于它的内联干燥药物组件33包括单一的双重目的构件71,其充当干燥药物剂量储存构件和均匀载液分布构件。该双重目的构件71具有类似于均匀载液分布构件58的构造之处在于它包括朝向母连接头44的均匀载液分布构件顶侧71A、朝向穿刺套管46的均匀载液分布构件下侧71B和均匀载液分布构件外围边缘72。均匀载液分布构件顶侧71A具有干燥药物剂量涂层73,其构成干燥药物剂量储存构件。均匀载剂分布构件下侧71B由一系列径向的沟槽62构成,各自终止在均匀载液分布构件外围边缘72中的开口63处用于实现从均匀载液分布构件下侧71B到均匀载液分布构件顶侧71A的流体连通。
虽然本发明已经描述了有限数目的实施例,本发明的许多变化,修改以及其它应用能在本申请权利要求书的范围内被做出。
Claims (4)
1.医疗装置,所述医疗装置与无针注射器、小瓶和载液一起使用,用于使得无针注射器填充有注射液用来向患者注射,所述无针注射器具有公连接头,所述小瓶具有小瓶瓶塞和小瓶内部,所述医疗装置具有纵向的装置中心线并且包括:
(a)小瓶转接器,所述小瓶转接器具有裙、穿刺套管和中心的直立的公连接头,所述裙具有用于伸缩地安装到小瓶上的向下悬垂的弯曲部件,所述穿刺套管用于当所述的伸缩地安装时刺穿瓶塞用来与小瓶内部流体连通,所述中心的直立的公连接头与所述穿刺套管流体连通并且用来连接到公连接头;以及
(b)内联干燥药物组件,所述内联干燥药物组件在所述母连接头和所述穿刺套管之间被内联地设置,所述内联干燥药物组件包括用于储存干燥药物剂量的干燥药物储存构件和均匀载液分布构件,所述均匀载液分布构件用于当从小瓶吸入载液到无针注射器以形成注射液时,促进所述载液均匀接触所述干燥药物储存构件。
2.根据权利要求1所述的装置,其中所述内联干燥药物组件包括用于储存所述干燥药物剂量的分离的干燥药物储存构件和用于促进所述均匀接触的分离的均匀载液分布构件。
3.根据权利要求1所述的装置,其中所述内联干燥药物组件包括用于储存所述干燥药物剂量和促进所述均匀接触的双重目的构件。
4.根据权利要求1到3中任一项所述的装置,其中所述均匀载液构件包括朝向所述母连接头的均匀载液构件顶侧、朝向所述穿刺套管的均匀载液分布构件下侧和均匀载液分布构件外围边缘,
所述均匀载液分布构件下侧具有多个径向的沟槽,各自终止在所述均匀载液分布构件外围边缘中的开口中,从而当抽吸无针注射器以将液体内容物从小瓶抽取到无针注射器时,使得载液从所述均匀载液分布构件下侧流向所述均匀载液分布构件顶侧。
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US20160081878A1 (en) | 2016-03-24 |
BR112015027555B1 (pt) | 2022-02-01 |
JP2016521177A (ja) | 2016-07-21 |
BR112015027555A2 (pt) | 2017-09-19 |
EP2983745B1 (en) | 2018-07-11 |
JP6199483B2 (ja) | 2017-09-20 |
WO2014181328A1 (en) | 2014-11-13 |
CN105228676B (zh) | 2018-01-05 |
US9943463B2 (en) | 2018-04-17 |
DK2983745T3 (en) | 2018-10-22 |
IL242063B (en) | 2019-05-30 |
EP2983745A1 (en) | 2016-02-17 |
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