CN1318999A - 用于静脉注射给药的容器 - Google Patents

用于静脉注射给药的容器

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CN1318999A
CN1318999A CN99811204A CN99811204A CN1318999A CN 1318999 A CN1318999 A CN 1318999A CN 99811204 A CN99811204 A CN 99811204A CN 99811204 A CN99811204 A CN 99811204A CN 1318999 A CN1318999 A CN 1318999A
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CN1184948C (zh
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古纳·安德森
伯特·彼得森
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Fresenius Kabi AB
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    • B65D47/00Closures with filling and discharging, or with discharging, devices
    • B65D47/04Closures with discharging devices other than pumps
    • B65D47/20Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge
    • B65D47/24Closures with discharging devices other than pumps comprising hand-operated members for controlling discharge with poppet valves or lift valves, i.e. valves opening or closing a passageway by a relative motion substantially perpendicular to the plane of the seat
    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
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    • AHUMAN NECESSITIES
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    • AHUMAN NECESSITIES
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    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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    • A61J1/2006Piercing means
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    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract

用于贮存和供给药液的装置,它包括一密封的成形的柔性容器(10),容器在其前端有一在其中放置一插入物(20)的容器开口部分(12)。在插入物的外面,容器伸入可取下的密封盖(14)中。在取下密封盖后,在插入物上固定一注射装置,通过挤压容器,就允许沿一个方向经过插入物进行液体供给。

Description

用于静脉注射给药的容器
本发明涉及用于贮存和供给药液的装置,它包括一密封的、一般做成瓶子形的柔性容器,在容器的开口上设有一插入物,在其上可以附加一注射装置。
在制药工业中,用吹塑聚合物材料制造一预先灌满的、做成瓶子形的容器以用于无菌液体,是非常公知的技术。这种吹塑-充灌-密封法例如已在US 4342184中公开。在欧洲专利清单EP 0 670 709中公开了一种用这种方法做的容器,该容器主要只包括聚烯烃基的材料,以致可以得到一对环境非常友善的容器,它对所储存的液体有很好的相容性,而且还满足这样的要求,即最后密封好的容器能用高压蒸汽消毒(即在120℃左右用高压锅蒸15分钟左右以上)。这种做成瓶子形的容器适于用剌穿其含弹胶体的弹性密封插入物的注射器针重复采集液体。这类容器由于其廉价而高效的生产方法而有许多优点,它们在许多应用中将成功地代替玻璃瓶或安瓿。这种容器的缺点为,它需要一定的技巧和准确度,以正确地刺穿插入物,以在瓶子和注射器之间建立液体连通,从而采集所要求的贮存液体量,以供给病人或转移至另一容器中。
EP 0 088 056和EP 0 326 391公开了做成瓶形的塑料安瓿,它具有可扭下的头部和一作为阴路厄氏(luer)形成的颈部,以便在从瓶子转送液体至注射器时与所连接的注射器的阳路厄尔头配合。在许多应用场合中,能直接使用做成瓶形的灌满的容器将其中的无菌液体供给病人是有利的。用可附加的注射器转移的步骤造成额外的程序,从而有污染和误操作的危险。
FR 27 18 017公开了一种用于液态药物的瓶子,它用聚合物材料制造并用一可附加的盖子密封。瓶子有一做成阳路luer状的接头的顶部,它连至具有相应的形状的套管(或类似装置)。在撕去盖子6以后,将一锁环11接合在瓶子开口法兰的外面。锁环用作瓶子开口与套管之间的安全而紧密的连接件。欧洲专利申请0 788 804描述了一种用聚合物材料做的柔性瓶。瓶子可含有冲洗液(氯化钠溶液),它例如可以刚好在药物或非肠道营养物的输入之前用于冲洗连至病人的静脉的导管。它基本上包括一个带有一个盖子的瓶子,使用者可以移去该盖子以打开其开口。一个带有套管固定装置的单独的连接块捅入该开口中。由此,装配好的装置可随时用于将瓶子的内容物供给病人或将液体转移至另一容器中。EP 0 788 804的装置有许多各种各样的明显的缺点。首先,连接器的插入过程不方便,造成医院人员的额外处理并且常常包括无意污染液体的危险。其次,如果用于静脉清洗,装置可能在通过挤压柔性瓶供给液体时将空气泡与液体一起送入。由于栓塞的危险,血液系统中进入空气泡是不能容忍的。
US 4 259 095、EP 0 310 227和FR 954 795也公开了装有药液的塑料瓶,它有可取下的盖子部分,露出用于与套管的相应的阴部分连接的阳luer颈部。此容器旨在提供可直接转变为用于将所贮存的液体注射给病人的给药工具的容器。不过,作为注射装置,与在供给液体时通过致动与活塞相连的活塞杆而操作的普通注射器相比,这些容器在许多方面是逊色的。传统的这类用吹塑-充灌-密封形成的容器的一个缺点为,在连接容器部件时,来自模制过程的接头仍然保留,损坏容器顶部与套管之间的luer连接的配合,更重要的是,如同用传统的注射器用常规的去空气步骤操作以避免注射空气那样,当要从注射液中去掉空气泡时,它们不能接受任何的安全程序。US 5 538 306揭示了这种可附加在套管上的做成瓶子形的可挤压的容器的结构,其目的在于克服上述问题,但是它的结构复杂,需要有包括几个步骤的规定的操作。
显然,需要有一种用于贮存药液的做成瓶子形的塑料容器,它随时可以用最少的复杂的操作转变成安全而方便的注射装置,从而就液体在处理时的污染而言有最大可能的安全性。如同在下面要说明的那样,这可以用本发明达到。
本发明涉及一种用于贮存和供给药液的装置,它包括一密封的、一般做成瓶子形或类似形状的柔性容器。在其前端,容器设有一开口部分,在其中密封地放置一插入物。为了防止在使用装置以前在搬运和贮存时保护插入物,容器在其制造时做成这样的形状,以致它直接伸入上述插入物外面的盖子中。盖子可以通过设有薄弱线或类似的可破裂区而被取下,以致在要使用容器中的液体并在容器与附加的最好带做成传统形状的套管的注射装置之间建立液体连通时,使用者可以通过筒单的扭转运动而取下整个盖子或其主要部分,露出插入物,该套管包括一连至一般为空心的锥形后部的前针部。这是通过将套管的后部固定在插入物的一般为管形的部分上完成的,该插入物具有一般为锥形的截面,与套管的空心部分相配。插入物的管状部分和套管的空心部分最好是相互合作的luer配合,以使上述管状部分对应于阳luer配合,而上述空心部分对应于阴luer配合。此外,为了保证注射装置能安全地固定在其上,插入物设有接合装置,它包括一在插入物中沿径向延伸的环形凹座,后者沿轴向伸入插入物中一个足够的距离,以保证传统的套管的固定,该套管有一做成阴luer配合形的后端。为了改进接合,环形凹座的外周边最好做有螺纹槽,以便在装置的插入物与套管之间形成一luer锁合固定。
本装置的一个重要特点为,它在处理和供给药液时只允许液体沿一个方向流动。可以避免空气意外进入容器中,从而可以避免意外地供给空气气泡,后者在最坏的情况下可造成栓塞。因此,插入物备有装置,以使它只允许沿一个方向有液体连通。此外,如果液体从注射装置经过插入物进入容器中,插入物也可以得到密封。这最好这样来完成,即插入物在其液体通路中设置一薄膜,它在有压力作用在柔性容器上时可在一第一密封位置与一第二打开位置之间移动。薄膜最好可沿轴向在两个预定的位置之间移动,以便起着止回阀机构的作用。本领域技术人员很容易选择一合适的不仅限于上述薄膜的阀机构并找到合适的打开压力。在本发明中,合适的阀打开压力低于约2.5mmH2O,并且最好低于约1mm H2O。为了提供对用无菌盐水冲洗例如限于使用非肠道营养物的病人的与静脉连接的导管是安全的装置,最好是通过病人的血压将薄膜移至密封位置,以使血液不会意外地被吸出,进入装置。合适的是,阀机构的打开压力大于病人的血压。
在某些应用场合中,装置的做成瓶子形的容器可以做成膜盒形,以便于在供给内容物时所需要的挤压运动。做成瓶子形的容器也可以设有指示液体的水准和所需要供给的剂量的大小的装置。
本发明的装置可如同在前述专利EP 0 670 709和US 4 342 184中较详细地说明的那样,用传统的吹塑-充灌-密封法制造。这种方法包括将聚合物材料吹塑成瓶子形并灌以药液,此时,将插入物放入容器的开口中,后者最后通过在插入物的外面用聚合物材料形成可取下的盖子而被密封。最后装配好的装置在离开制造厂以前可以用高压蒸汽(高压锅蒸)或用辐射经受杀菌步骤。
除去用氯化钠溶液冲洗输注装置外,本发明的装置可在大量的应用场合中使用。例如,可以在刚好供给一输注袋的内容物之前,可以用于通过刺穿它的一个口将补充液增补到袋中。也可以设想,用该装置作为单剂量或多剂量注射器,以通过例如注射像肝素或低分子量肝素如Fragmin这样的抗血栓形成剂直接供药给病人。
图1示出了容器的示意图,带有插入物的轴向剖视图。
参看图1,装置包括一大体上做成瓶形的容器体10,后者在其前端有一开口部分12,在开口部分上放置一插入物20。容器直接伸入一密封盖14中,后者做成易于用使用者的扭转运动取下。由于这一原因,盖子上做有预先形成的易于断开的断裂线15。插入物有一大致为管形的部分22,它与容器体作液体连接。管状部分的前端用塞子21密封,后者意在盖子断裂时同时被取下。管状部分有一大致为锥形的截面,以便与套管的做成相应的形状的空心后部配合。由此,套管可用luer配合固定在管状部分上。为了帮助该固定,插入物上做有一个环形凹座24,它伸入插入物中一个合适的轴向距离。凹座可以做有螺纹槽25,以改进与套管的接合。这些部分的尺寸要如此选择,以使它们遵守阳阴luer配合的ISO/DIN标准。为了实现只沿一个方向经过插入物的液体连通,设置一阀机构。插入物包括两部分,前部20A和后部20B,前部具有前述管状部分和能与套管建立一luer锁紧连接的环形凹座。插入物的各部分最好都用能相容的同样的聚合物材料制造并用传统的措施紧密地焊在一起。插入物的后部做有被容纳在壳体27中的密封薄膜26,该壳体与行经管状部分22的通路23和通路28作液体连接。薄膜为一固定在其壳体27中的有弹性的硅酮(Silicon)密封薄膜,它在壳体中可沿轴向在一打开位置和一密封位置之间移动。薄膜与壳体的尺寸要做成使之在容器10上例如通过挤压容器而作用一预定的正压力时,允许与通路23作液体连通,要不然的话,机构就保持在其密封位置上。插入物的后部由此就起着止回阀的作用,并且在附接的套管与病人处于静脉注射接触,而且有血压作用在阀机构上时,能关闭并密封该装置,一直到有一超过血压的压力作用在容器上以向病人供给药液为止。因此,而设计的插入物将提供一种装置,它可冲洗装置,同时用于暂时与病人的静脉相连的静脉注射给药,和通过注射一定剂量的药液的传统给药,而没有意外地将空气送入病人的危险,这种空气例如可通过无意的操作而被吸入装置中。容器的操作将极其简单和可靠,而且起初只限于这样的步骤,即沿预先形成的断裂线取下盖子并将套管固定在插入物上。以后,如果需要,容器可以通过按竖立的位置轻轻地被挤压而经受去空气步骤,直至液体从针上被挤出和/或没有留有空气气泡的可见的迹象。以后就可通过按规定的方式筒单地挤压容器实现给药。
装置最好主要用聚合物材料制造,它可以回收,同时不需要花劳动力将其拆散并分开收集其各个部分。用于该容器的优选的材料为聚烯烃,尤其是聚丙烯及其共聚物。插入物可以用聚丙烯或聚碳酸酯制造。阀上的乳胶薄膜的不重要的份额不妨碍普通的回收使用,因为它的重量比整个容器的1%还少。

Claims (12)

1.用于贮存和供给药液的装置,它包括一密封的成形的柔性容器(10),容器在其前端有一在其中放置一插入物(20)的容器开口部分(12),其中,上述容器伸入在上述插入物上面的可取下的密封盖(14)中,其特征为,在取下密封盖以后,插入物可直接固定在一注射装置上,并在供给液体时,上述插入物允许使用附加的注射装置只沿一个方向有液体连通。
2.如权利要求1的装置,其特征为,上述注射装置是一套管,它做有一般为锥形的空心部分,以用于固定在插入物上。
3.如权利要求2的装置,其特征为,插入物做有一般为管形的部分(22),后者一般有一锥形截面,与套管的空心部分相配。
4.如权利要求3的装置,其特征为,插入物的管形部分(22)和套管的空心部分是配合作用路厄氏的luer配合。
5.如权利要求1的装置,其特征为,插入物做有与注射装置接合的装置。
6.如权利要求2或5的装置,其特征为,上述插入物做有用于套管的空心部分的接合装置。
7.如权利要求6的装置,其特征为,插入物做有沿径向延伸的环形凹座(24)。
8.如权利要求7的装置,其特征为,环形凹座的外周边(25)上做有螺纹槽。
9.如权利要求8的装置,其特征为,插入物做有能密封插入物,使之不与注射装置作液体连通的装置。
10.如权利要求9的装置,其特征为,能密封插入物的装置包括一沿径向延伸的薄膜,它在有压力作用在柔性容器(10)上时沿轴向从第一密封位置移至第二打开位置,以便允许液体从容器连通至注射装置。
11.如权利要求10的装置,其特征为,如果被血压动作,薄膜就移至密封位置。
12.如权利要求1的装置,其特征为,柔性容器是膜盒形的。
CNB998112046A 1998-09-22 1999-09-21 用于静脉注射给药的容器 Expired - Lifetime CN1184948C (zh)

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CN101721309A (zh) * 2008-11-03 2010-06-09 马伟博 输液袋和与它配套使用的输液器
CN101856306A (zh) * 2009-04-13 2010-10-13 马伟博 玻璃药瓶的瓶盖
CN101856306B (zh) * 2009-04-13 2013-02-27 马伟博 玻璃药瓶的瓶盖
CN104203194A (zh) * 2012-02-02 2014-12-10 碧迪股份有限公司 用于与医用容器相联接的适配器
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US6796971B2 (en) 2004-09-28
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