CN1216475A - 注射针 - Google Patents

注射针 Download PDF

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CN1216475A
CN1216475A CN97194080A CN97194080A CN1216475A CN 1216475 A CN1216475 A CN 1216475A CN 97194080 A CN97194080 A CN 97194080A CN 97194080 A CN97194080 A CN 97194080A CN 1216475 A CN1216475 A CN 1216475A
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pin
needle
diameter
entry needle
insulin
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吉姆·斯特恩嘉德
斯特芬·拉夫
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Novo Nordisk AS
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Novo Nordisk AS
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/329—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles characterised by features of the needle shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/347—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub rotatable, e.g. bayonet or screw

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Fuel-Injection Apparatus (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Polyesters Or Polycarbonates (AREA)
  • Catalysts (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

一种装在针头接口上的针,该接口配合在一注射装置上,来自容纳在该装置中的药盒的预定剂量的药物可以通过该针被引入,该针包括一穿过药盒的封闭薄膜的背针和一短于9mm的自由注射部分,针的外径和其孔径遵守下列条件之一:a)外径小于0.320mm并且孔径大于0.165mm,或b)外径小于0.298mm并且孔径大于0.133mm。

Description

注射针
本发明涉及注射针，特别是装在一针头接口上并露出一背针和一自由注射部分的针，该接口配合在这样一种注射装置上，即来自容纳在该装置中的药盒的预定剂量的药物可以从该装置经过装在该装置上的针被引入，而且背针穿过药盒的封闭薄膜。
剂量可以单独设定并且可以在其上安装注射针和在注射针已经用于注射来自装置中的药盒的药物之后对其进行更换的这种注射装置对于不得不每天自己注射一次或更多次的人来说是一种常用的工具，因为确实有这样的情况，有一些人，他们要用生长激素或降糖灵进行治疗，他们不得不经常自己注射，以将他们的血糖保持在可接受的水平上。
为了减少由于经常扎刺皮肤而引起的不适，有一种倾向于使用更细的针的趋势，因为已经表明，用细针扎刺引起的疼痛要少于由粗针扎刺而引起的疼痛。采用较细的针会产生其它的问题，其中之一为，例如某些胰岛素具有粗大的晶粒，这些晶粒容易堵塞在通往注射针的入口处，这样晶粒就会从晶粒在其中悬浮的液体中被筛分出来。这样，所注射的胰岛素的浓度可能会与使用者所想的不同，由此可能会引起注射错误的剂量。
根据WO 93/00948，这些问题已经通过使用安装在特殊的针头接口上的注射针予以克服，该接口只配合在已经公知的下述装置上，即该装置只含有能自由流经被规定为G30针的细针的胰岛素。这是通过将装置做成如下所述的那样而达到的，即它保证只含有晶粒尺寸小于15μm的胰岛素并且设有针接纳件，在该针接纳件上配有具有细针的接口。可以注意到，较粗的针自然可以设有相应的接口，因为装置中的胰岛素自然可以毫无问题地经过具有较大孔的粗针。
虽然G30针引起较少的疼痛并且甚至允许结晶胰岛素通过(只要晶粒的尺寸不大于15μm)，但是这种针的使用并不是没有问题的，即使在注射溶液时也将存在一些问题。问题之一是必须在从其压出药物的药盒中建立较高的压力，这就又意味着必须在用手操作的注射钮上施加超常的作用力。这可能使手指力量弱的使用者难以足够迅速地进行注射。由于在药盒中存在高压，药盒部分的弹性，特别是橡胶薄膜和活塞的弹性可能使注射针在其从在注射过程中插入的组织中拔出时产生滴漏。这就意味着，实际上并没有注射全部的设定剂量。上述药盒主要是这样一种类型的，其中，一个活塞封闭圆柱形针剂瓶的一端，而另一端则用一橡胶薄膜封闭，该橡胶薄膜可用双针头针的背针穿过，以便针剂瓶的内含物经过中空的注射针流至此注射针的注射点。
本发明的目的在于提供一种细的注射针，由此可以加强G30针的优点和/或克服此针的缺点。
这一目的可以通过一种在本说明书的开头描述过的那种注射针来达到，按照本发明，该注射针的特点为，注射部分的长度小于9mm，而且针的外径和针孔符合下列条件之一：
a)外径小于0.320mm并且针孔的直径大于0.165mm，或者
b)外径小于0.298mm并且孔的直径大于0.133mm。
由于标准的ISO 9626描述了用于注射针的公差，它规定，针的长度可比针的名义长度长一毫米或短两毫米，并且对于普通的G30，针的外径必须在0.320mm和0.298mm的范围内，针孔的直径必须在0.133mm与0.165mm的范围内，因此特征性条款可以用文字另外表达成：
注射部分的长度名义上为8mm或更少，并且
满足下列两个条件之一：
a)外径对应于G30针的外径并且针孔的直径大于普通G30针的针孔直径，或者
b)外径小于G30针的外径并且针孔直径大于普通G30针中针孔的最小直径。
根据WO 93/00948，已经知道使用G30针从一个其药盒中盛装有最大晶粒尺寸为15μm的胰岛素的笔中注射胰岛素。这可以保证贮存在这种注射装置中的胰岛素能自由地流过针孔直径大于0.133mm的针，而该针孔为标准G30针中出现的最小针孔。当然其它种类的完全不含晶粒的药物也能通过这种标准的G30针。
在外径小于0.320mm的针中采用较小的壁厚将允许在G30针中有较大的针孔，由此导致有较好的经过注射针的流动。另外，如果接受0.133mm的针孔直径，则采用薄壁可允许使用比G30针更细的针，但是这种针仍然保证装置中甚至存在结晶胰岛素时也能自由流动。
薄壁G30针是已知的，但是由于有这样的观点，即具有薄壁的细针由于有断针的危险而应当由专业人员使用，因此以前未曾将薄壁针制造成可与用于由本人注射药物如胰岛素的注射装置一起使用。但是，如同在WO 93/00948中所描述的那样，像标准的G30那样细的针已经显示出在用于自我注射时是安全的，同时由于当壁厚减少50％时针管的弯曲强度只降低6％，因此即使在非专业人员的手中，短的薄壁注射针也将是安全的。
按照本发明，针的注射部分短于9mm，而且可以合适地是4～8mm。采用较短的注射针，折断的危险将被降低，进而将使短针优选地用于皮下注射，因为采用短针减少了将针插得深过皮下组织的危险。另外，由于该注射针可与这样一种注射装置一起使用，即可从该装置的药盒中引入预定剂量的药物，针的必须穿过封闭薄膜的部分是可以穿过薄膜而且不存在任何不允许弯曲的危险的短背针。
下面将参考附图更详细地说明本发明，图中：
图1是示意地表示具有按照本发明的针的针头接口的剖视图；和
图2是表示一段针管的剖视图。
在图1中，注射针装在一针头接口上，该接口包括一圆盘形元件1，元件1沿其周边具有一环形的悬垂套筒，该套筒在其内壁上设有螺纹4，通过该螺纹可将针头接口拧在注射器的针接受部分上，该针接受部分上设有外螺纹。元件1在其中心设有一个突起2，该突起沿套筒的反向从圆盘伸出。一个双针头针从中心穿过突起2和盘形元件1地安装，以使形成用于刺入使用者的皮肤的注射部分的一个针头端部5从突起2突出，而所谓的背针6则从圆盘的反面侧伸出，从而使其被套筒3同心地包围。背针6比套筒3短，由此此套筒在某种程度上保护了背针的针头端。注射针的注射部分5具有小于9mm的长度L，按照ISO 7864:1993E，该长度为作为8mm针宣布的针所能接受的最大长度。通过限制和减小此长度，使在针的注射部分5插入皮肤时作用在这部分上的弯矩得以减少。在将注射针装在注射器上时必须穿透针剂瓶的封闭薄膜的背针6还要更短一些。这是有利的，因为这种薄膜比皮肤更难于刺透。未得到支承的针的有限长度使壁厚减少并由此使弯曲强度减小为可以接受的。
图2示意地示出了具有一个壁8和一个孔7的一段针管的剖视图。该注射针的特征由其外径D和针孔的直径d来表征。减小壁厚可用于在按照ISO 9626像G30那样细的针中得到较大的针孔直径d，或用于得到这样一种注射针，它的针孔直径d至少对应于G30针的最小直径并且外径D小于G30针的最小直径。这可以用下列条件表示：
d≥0.165mm，和D≤0.320mm或者
d≥0.133mm，和D≤0.298mm连同必须始终遵守的下列条件：d+2x(壁厚)=D。
可以被接受的最小壁厚由对针的弯曲强度设定的要求确定。

Claims (6)

1．一种装在针头接口上并露出一背针和一自由注射部分的注射针，该接口配合在这样一种注射装置上，即来自容纳在该装置中的药盒的预设剂量的药物可以通过装在该装置上的注射针被引入，其中背针穿过药盒的封闭薄膜，其特征为，注射部分的长度小于9mm，并且针的外径和针孔的直径符合下列条件之一：
a)外径小于0.320mm并且针孔的直径大于0.165mm，或者
b)外径小于0.298mm并且针孔的直径大于0.133mm。
2．如权利要求1所述的注射针，其特征为，针头接口被设计用于配合在一种用于胰岛素的注射系统上。
3．如权利要求1所述的注射针，其特征为，针头接口被设计用于配合在一种用于胰岛素的类似物的注射系统上。
4．如权利要求2或3所述的注射针，其特征为，注射系统只容纳具有胰岛素类的药盒，该胰岛素类是溶液或具有最大直径为15μm的粒子的悬浮液。
5．如权利要求1所述的注射针，其特征为，针头接口被设计用于配合在一种用于生长激素的注射系统上。
6．如权利要求1-5之一所述的注射针，其特征为，注射针的自由注射部分具有在4-8mm范围内的长度。
CN97194080A 1996-04-24 1997-04-24 注射针 Pending CN1216475A (zh)

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DK0491/96 1996-04-24
DK49196 1996-04-24

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US (1) US5951530A (zh)
EP (1) EP0895481B1 (zh)
JP (1) JP2001527435A (zh)
KR (1) KR20000010631A (zh)
CN (1) CN1216475A (zh)
AT (1) ATE196096T1 (zh)
AU (1) AU724937B2 (zh)
BR (1) BR9708857A (zh)
CA (1) CA2252620A1 (zh)
CZ (1) CZ338998A3 (zh)
DE (1) DE69703038T2 (zh)
DK (1) DK0895481T3 (zh)
ES (1) ES2152662T3 (zh)
IL (1) IL126618A0 (zh)
NO (1) NO984953L (zh)
PL (1) PL329478A1 (zh)
RU (1) RU2180861C2 (zh)
UA (1) UA47468C2 (zh)
WO (1) WO1997039787A1 (zh)
ZA (1) ZA973558B (zh)

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ZA973558B (en) 1998-02-23
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JP2001527435A (ja) 2001-12-25
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AU2634797A (en) 1997-11-12
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PL329478A1 (en) 1999-03-29
ATE196096T1 (de) 2000-09-15
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US5951530A (en) 1999-09-14
EP0895481B1 (en) 2000-09-06

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