JPWO2007020998A1 - Safety prefilled syringe - Google Patents

Safety prefilled syringe Download PDF

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JPWO2007020998A1
JPWO2007020998A1 JP2007531036A JP2007531036A JPWO2007020998A1 JP WO2007020998 A1 JPWO2007020998 A1 JP WO2007020998A1 JP 2007531036 A JP2007531036 A JP 2007531036A JP 2007531036 A JP2007531036 A JP 2007531036A JP WO2007020998 A1 JPWO2007020998 A1 JP WO2007020998A1
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gasket
needle
prefilled syringe
coupled
plunger
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JP5163123B2 (en
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佐野　實
實 佐野
與志久 濱
與志久 濱
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Nipro Corp
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Nipro Corp
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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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • 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
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • 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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5066—Means for preventing re-use by disconnection of piston and piston-rod

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

保管時に液密を達成でき且つ注射後に針を注射筒内に収納可能な構造を持つプレフィルドシリンジを提供すること。先端に接続部１１を有しかつ基端が開口した注射筒１と、前記接続部１１を封止できかつ着脱自在な蓋部材４と、前記注射筒１内に液密に摺動自在に設けられたガスケット２と、前記ガスケット２の基端に連結するプランジャー３とを含む、前記注射筒１内に薬剤が充填されたプレフィルドシリンジＡであって、前記ガスケット２は先端部に結合手段２１が設けられるとともに、前記結合手段２１と前記ガスケット２の基端部との間に前記注射筒１内部の薬剤１５を外部から隔離できる隔壁部２３が設けられたことを特徴とするプレフィルドシリンジＡ。To provide a prefilled syringe having a structure capable of achieving liquid tightness during storage and storing a needle in a syringe barrel after injection. A syringe barrel 1 having a connection portion 11 at the distal end and having an open base end, a lid member 4 that can seal the connection portion 11 and is detachable, and a fluid-tight slide in the syringe barrel 1 The prefilled syringe A is a prefilled syringe A filled with a medicine in the syringe barrel 1 and includes a plunger 3 connected to the proximal end of the gasket 2, and the gasket 2 is coupled to a distal end portion of the means 21. The prefilled syringe A is characterized in that a partition wall portion 23 is provided between the coupling means 21 and the proximal end portion of the gasket 2 so that the medicine 15 inside the syringe barrel 1 can be isolated from the outside.

Description

本発明は、使用後の誤穿刺防止のための針収納機構を備えたプレフィルドシリンジに関する。   The present invention relates to a prefilled syringe provided with a needle storage mechanism for preventing erroneous puncture after use.

従来から、患者に注射器による薬剤投与を行った後、プロテクターにより注射針をリキャップする際、看護師等の医療従事者が手指に患者の血液が付着した注射針を誤って穿刺してしまう、所謂、誤穿刺が問題とされてきた。誤穿刺による医療従事者への病気の伝染、感染等の医療事故を防ぐため、リキャップを行わず、例えば特許文献１に示されたような注射針に手をふれることなく針を廃棄する廃棄容器等を使用する医療機関もある。   Conventionally, a medical worker such as a nurse mistakenly punctures an injection needle with a patient's blood adhering to a finger when a patient is administered a drug by a syringe and then the cap is recapped by a protector. Incorrect puncture has been a problem. In order to prevent medical accidents such as infection and infection of illnesses to medical personnel due to erroneous puncture, a waste container that does not perform recapping and discards the needle without touching the injection needle as disclosed in Patent Document 1, for example Some medical institutions use such as.

しかしながら、救命救急室等、患者に対し迅速な医療処置が要求される場所、或いは廃棄容器を設置することが困難な場所においては、廃棄容器による注射針の廃棄は不可能である。 However, in a life-saving emergency room or the like where a prompt medical treatment is required for a patient, or where it is difficult to install a disposal container, it is impossible to discard the injection needle.

そこで、例えば特許文献２に示されたような、使用後に注射針を注射筒内に引き込む方式を採用することにより、誤穿刺を防止する注射器の発明がなされている。   Therefore, for example, an invention of a syringe that prevents erroneous puncture has been made by adopting a system in which an injection needle is pulled into a syringe barrel after use as shown in Patent Document 2, for example.

また、例えば特許文献３に示されたような、使用後に注射筒の外筒を前方にスライドさせ、該外筒で注射針の先端部まで覆う方式を採用することにより、誤穿刺を防止する注射器の発明もなされている。   Further, for example, as shown in Patent Document 3, a syringe that prevents an erroneous puncture by adopting a system in which an outer cylinder of an injection cylinder is slid forward after use and the distal end of the injection needle is covered with the outer cylinder. The invention has also been made.

特開平１−２４２０６４号公報JP-A-1-240206 特開２００３−２０５０３５号公報JP 2003-205035 A 特開平５−３３７１８２号公報JP-A-5-337182

しかし、特許文献２記載の注射器は、プランジャーがガスケットを貫通しているため（図８）、当該注射器を予め薬剤が充填された所謂プレフィルドシリンジに採用すると、ガスケットとプランジャーとの間の僅かな隙間から薬剤が漏出したり注射筒内の薬剤に雑菌が混入したりするおそれがあるため、プレフィルドシリンジの容器としては採用できない。また、プレフィルドシリンジの製造工程においては、注射筒内に薬剤を充填し、ガスケットを真空打栓した後、プランジャーをガスケットに取り付けるのが一般的である。そのため、特許文献２記載の注射器では、ガスケットに軸方向の貫通孔が形成されているため、注射筒内を陰圧にして、注射筒内と外界との圧力差によってガスケットを打栓する真空打栓を行うことはできない。   However, since the plunger described in Patent Document 2 has a plunger penetrating the gasket (FIG. 8), when the syringe is used in a so-called prefilled syringe pre-filled with a medicine, there is a slight gap between the gasket and the plunger. Since there is a possibility that the medicine leaks from a large gap or a germ is mixed into the medicine in the syringe, it cannot be used as a prefilled syringe container. Moreover, in the manufacturing process of a prefilled syringe, it is common to attach a plunger to a gasket after filling a syringe with a medicine and vacuum-sealing the gasket. For this reason, in the syringe described in Patent Document 2, since the axial through hole is formed in the gasket, the inside of the syringe barrel is set to a negative pressure, and the gasket is punched by a pressure difference between the inside of the syringe barrel and the outside. It cannot be plugged.

また、特許文献３記載の注射器は、注射筒よりも大きな外筒を採用するため、部材コストがかさむ。さらに、使用後においても外筒の先端は開口しているため、誤って手指が開口部又は開口部付近に接触すると、やはり誤穿刺や血液との接触の虞がある。また、使用後に外筒が後方にスライドすると、再び注射針が露出することになり、誤穿刺を完全に防止することはできない虞がある。そこで、液漏れが生じない構造が必要である。   Moreover, since the syringe of patent document 3 employ | adopts an outer cylinder larger than an injection cylinder, member cost increases. Furthermore, since the distal end of the outer cylinder is open even after use, there is a risk of erroneous puncture and contact with blood if a finger accidentally contacts the opening or the vicinity of the opening. Further, when the outer cylinder slides backward after use, the injection needle is exposed again, and there is a possibility that the erroneous puncture cannot be completely prevented. Therefore, a structure that does not cause liquid leakage is required.

本発明の目的は保管時に液密を達成でき且つ注射後に針を注射筒内に収納可能な構造を持つプレフィルドシリンジを提供することにある。   An object of the present invention is to provide a prefilled syringe that can achieve liquid tightness during storage and has a structure that allows a needle to be housed in a syringe barrel after injection.

そこで、本発明者らは、
（１）先端に接続部を有しかつ基端が開口した注射筒と、前記接続部を封止できかつ着脱自在な蓋部材と、前記注射筒内に液密に摺動自在に設けられたガスケットと、前記ガスケットの基端に連結するプランジャーとを含む、前記注射筒内に薬剤が充填されたプレフィルドシリンジであって、前記ガスケットは先端部に結合手段が設けられるとともに、前記結合手段と前記ガスケットの基端部との間に前記注射筒内部の薬剤を外部から隔離できる隔壁部が設けられたことを特徴とするプレフィルドシリンジ。
（２）前記接続部の前記蓋部材と交換可能に取付けられる針組立体であって、注射針と、前記注射針の基端に固着され基端に前記結合手段に結合される被結合手段が設けられた針基と、前記注射針が挿通し、前記針基を先端方向に嵌合可能かつ基端方向に離脱可能な針基蓋部材とを含むことを特徴とする針組立体。
（３）（１）記載のプレフィルドシリンジと、（２）記載の針組立体とを含むことを特徴とするプレフィルドシリンジ組立体。
（４）前記結合手段が、前記被結合手段に結合するように、前記ガスケットの先端に形成された結合部であることを特徴とする（１）に記載のプレフィルドシリンジ。
（５）前記結合手段が、前記ガスケットの先端に取付けられ、前記被結合手段に結合される結合部材であることを特徴とする（１）に記載のプレフィルドシリンジ。
（６）前記接続部内部に、前記針基の基端方向への移動を制限する係合部を設けたことを特徴とする（１）に記載のプレフィルドシリンジ。
（７）前記ガスケット基端および前記プランジャー先端に、前記ガスケットと前記プランジャーとが連結される連結部が設けられることを特徴とする（１）に記載のプレフィルドシリンジ。
（８）前記連結部が、前記ガスケットと前記プランジャーとが連結可能かつ連結解除不能となるように設けられた嵌合凸部および嵌合凹部であることを特徴とする（７）に記載のプレフィルドシリンジ。
（９）前記被結合手段が、前記結合手段に結合するように、前記針基の基端に形成した被結合部であることを特徴とする（２）に記載の針組立体。
（１０）前記被結合手段が、前記針基の基端に取付けられ、前記結合手段に結合する前記被結合部材であることを特徴とする（２）に記載の針組立体。
（１１）前記プランジャーの前記連結部基端側を切離し可能とする切離手段が設けられていることを特徴とする（１），（７），（８）に記載のプレフィルドシリンジ。
（１２）前記切離手段が、前記プランジャー側部に設けられた切欠きであることを特徴とする（１１）に記載のプレフィルドシリンジ。
を用いることにより、ガスケットの結合手段と連結部との間に隔壁部を有するため、注射筒内と外界とが液密となり保管時においては注射筒内より薬剤が漏出したり注射筒内の薬剤に雑菌が混入したりすることがなく、注射後には注射針に触れることなく注射針を注射筒内に収納可能であるため注射後の誤穿刺による医療事故を回避することができることを見出し本願発明に至った。Therefore, the present inventors
(1) A syringe barrel having a connecting portion at the distal end and having an open proximal end, a lid member that can seal the connecting portion and is detachable, and a fluid-tight slidable member provided in the syringe barrel A prefilled syringe filled with a medicine in the syringe barrel including a gasket and a plunger connected to a proximal end of the gasket, wherein the gasket is provided with a coupling means at a distal end portion; and the coupling means; A prefilled syringe, characterized in that a partition wall is provided between the base end of the gasket and the medicine inside the syringe barrel can be isolated from the outside.
(2) A needle assembly that is replaceably attached to the lid member of the connecting portion, and includes: an injection needle; and a coupled means that is fixed to the proximal end of the injection needle and coupled to the coupling means at the proximal end. A needle assembly comprising: a provided needle base; and a needle base cover member through which the injection needle is inserted, the needle base can be fitted in the distal direction, and can be detached in the proximal direction.
(3) A prefilled syringe assembly comprising the prefilled syringe according to (1) and the needle assembly according to (2).
(4) The prefilled syringe according to (1), wherein the coupling means is a coupling portion formed at a tip of the gasket so as to couple to the coupled means.
(5) The prefilled syringe as set forth in (1), wherein the coupling means is a coupling member attached to a tip of the gasket and coupled to the coupled means.
(6) The prefilled syringe as set forth in (1), wherein an engagement portion that restricts movement of the needle base in the proximal direction is provided inside the connection portion.
(7) The prefilled syringe as set forth in (1), wherein a connecting portion for connecting the gasket and the plunger is provided at the gasket base end and the plunger tip.
(8) The coupling portion is a fitting convex portion and a fitting concave portion provided so that the gasket and the plunger can be coupled and cannot be uncoupled. (7) Prefilled syringe.
(9) The needle assembly according to (2), wherein the coupled means is a coupled portion formed at a proximal end of the needle base so as to be coupled to the coupling means.
(10) The needle assembly according to (2), wherein the coupled means is the coupled member attached to a proximal end of the needle base and coupled to the coupling means.
(11) The prefilled syringe according to any one of (1), (7), and (8), characterized in that a separating means is provided that enables the base end side of the connecting portion of the plunger to be separated.
(12) The prefilled syringe according to (11), wherein the separating means is a notch provided in a side portion of the plunger.
By having a partition part between the coupling means and the connecting part of the gasket, the inside of the syringe barrel and the outside are liquid-tight, and during storage, the medicine leaks from the inside of the syringe barrel or the medicine in the syringe barrel The present invention has found that a medical accident due to erroneous puncture after injection can be avoided because the injection needle can be accommodated in the syringe barrel without touching the injection needle after injection. It came to.

本発明のプレフィルドシリンジは上述のように、結合手段と連結部との間に隔壁部を設けることで液密が達成でき、使用後に針が収納できる構造となるため、ガスケットからの液漏れや注射筒内への雑菌の混入の心配がなく使用後の誤穿刺が防止できるため医療に好適に用いることができる。   As described above, the prefilled syringe of the present invention can achieve liquid tightness by providing a partition wall between the coupling means and the connecting portion, and has a structure in which the needle can be stored after use. Since there is no worry of contamination of germs in the cylinder and erroneous puncture after use can be prevented, it can be suitably used for medical treatment.

本発明の注射器用プランジャーについての一実施態様例の縦断面図。The longitudinal cross-sectional view of the example of one embodiment about the plunger for syringes of this invention. （ａ），（ｂ）ガスケットとプランジャーとの連結部についての他の実施様態例の部分拡大縦断面図。(A), (b) The partial expansion longitudinal cross-sectional view of the example of another embodiment about the connection part of a gasket and a plunger. （ａ），（ｂ）ガスケットに設けられた結合手段の他の実施様態例の部分拡大縦断面図。(A), (b) The partial expansion longitudinal cross-sectional view of the other implementation example of the coupling | bonding means provided in the gasket. 本発明の針組立体についての一実施態様例の縦断面図である。It is a longitudinal cross-sectional view of one embodiment of the needle assembly of the present invention. （ａ），（ｂ）針基に設けられた被結合手段の他の実施様態例の部分拡大縦断面図。(A), (b) The partial expansion longitudinal cross-sectional view of the other Example of implementation of the to-be-joined means provided in the needle base. 図１に記載したプレフィルドシリンジに図４に記載した針組立体を装着したプレフィルドシリンジ組立体の縦断面図FIG. 4 is a longitudinal sectional view of a prefilled syringe assembly in which the needle assembly shown in FIG. 4 is mounted on the prefilled syringe shown in FIG. 図６に記載したプレフィルドシリンジの薬剤投与後の処理方法についての縦断面図。The longitudinal cross-sectional view about the processing method after the chemical | medical agent administration of the prefilled syringe described in FIG. 従来の針収納型シリンジのプランジャーの先端部分拡大縦断面図である。It is a front-end | tip part enlarged vertical sectional view of the plunger of the conventional needle | hook accommodation type syringe.

符号の説明Explanation of symbols

Ａ プレフィルドシリンジ
Ｂ 針組立体
Ｃ プレフィルドシリンジ組立体
１ 注射筒
１１ 接続部
１１１ リブ
１２ 開口部
１５ 薬剤
２ ガスケット
２０ 連結部
２１ 係合手段
２１１ 係合手段
２１２ 係合手段
２２ 雌ねじ
２３ 隔壁部
２４ 嵌合凹部
３ プランジャー
３１ 雄ねじ
３２ 嵌合凸部
３３ 切離手段
３３１ 切欠き
４ 蓋部材
５ 注射針
６ 針基
６１ 被係合手段
６１１ 被係合手段
６１２ 被係合手段
６２ 上爪
６３ 下爪
７ 針基蓋部材
７１ 針基嵌合部
７２ 孔
８ 針カバー
A Prefilled syringe B Needle assembly C Prefilled syringe assembly 1 Syringe 11 Connection part 111 Rib 12 Opening part 15 Drug 2 Gasket 20 Connection part 21 Engagement means 211 Engagement means 212 Engagement means 22 Female screw 23 Bulkhead part 24 Fitting Concave part 3 Plunger 31 Male thread 32 Fitting convex part 33 Separation means 331 Notch 4 Lid member 5 Injection needle 6 Needle base 61 Engagement means 611 Engagement means 612 Engagement means 62 Upper claw 63 Lower claw 7 Needle Base cover member 71 Needle base fitting portion 72 Hole 8 Needle cover

以下、図を用いて本発明のプレフィルドシリンジを説明する。しかし、本願発明は、これら図面に記載した実施態様例に限定されるものではない。   Hereinafter, the prefilled syringe of this invention is demonstrated using figures. However, the present invention is not limited to the exemplary embodiments described in these drawings.

図１は、本発明のプレフィルドシリンジについての一実施態様例の縦断面図である。図２（ａ）及び（ｂ）はガスケットとプランジャーとの連結部についての他の実施様態例の部分拡大縦断面図である。図３（ａ）及び（ｂ）はガスケットに設けられた結合手段の他の実施様態例の部分拡大縦断面図である。図４は、本発明の針組立体についての一実施態様例の縦断面図である。図５（ａ）及び（ｂ）は針基に設けられた被結合手段の他の実施様態例の部分拡大縦断面図である。図６は図１に記載したプレフィルドシリンジに図４に記載した針組立体を装着したプレフィルドシリンジ組立体の縦断面図である。図７は図６に記載したプレフィルドシリンジの薬剤投与後の処理方法についての縦断面図である。図８は従来の針収納型シリンジのプランジャーの先端部分拡大縦断面図である。   FIG. 1 is a longitudinal sectional view of an embodiment of the prefilled syringe of the present invention. 2 (a) and 2 (b) are partially enlarged longitudinal sectional views of other embodiments of the connecting portion between the gasket and the plunger. 3 (a) and 3 (b) are partially enlarged longitudinal sectional views of other embodiments of the coupling means provided on the gasket. FIG. 4 is a longitudinal sectional view of an embodiment of the needle assembly of the present invention. 5 (a) and 5 (b) are partially enlarged longitudinal sectional views of other embodiments of the coupled means provided on the needle base. 6 is a longitudinal sectional view of a prefilled syringe assembly in which the needle assembly shown in FIG. 4 is mounted on the prefilled syringe shown in FIG. FIG. 7 is a longitudinal sectional view of a processing method after drug administration of the prefilled syringe shown in FIG. FIG. 8 is an enlarged longitudinal sectional view of the distal end portion of a plunger of a conventional needle-accommodating syringe.

図１は、注射筒１とガスケット２とプランジャー３と蓋部材４とを含むセーフティプレフィルドシリンジである。注射筒１は中空の略円筒状であって、先端には流路を持つ接続部１１を有し、基端に開口部を持つ。接続部１１にはリブ１１１が設けられ、着脱自在の蓋部材４により流路が閉鎖されている。注射筒１の内部にはガスケット２が液密且つ注射筒１の軸方向に摺動可能に収納され、注射筒１とガスケット２と蓋部材４とで囲まれた空間１５に薬液を含んでいる。ガスケット２の先端に、結合手段である先端内壁に環状のリブを設けた筒体２１がガスケットと一体に形成され、基端に嵌合凹部２４が設けられている。ここで、ガスケット先端に形成された筒体２１は注射筒１に形成された接続部１１と同軸上に形成される。筒体２１と嵌合凹部２４との間には隔壁部２３が形成されており、隔壁部２３によって先端が縮径した筒体２１と連結部２０である嵌合凹部２４とが隔てられることによって注射筒内と外界とが液密となっている。嵌合凹部２２と嵌合可能な嵌合凸部３２を先端に設けたプランジャー３がガスケット２に装着され、プランジャーには注射筒からプランジャーを分離するための切離手段３３である切欠き３３１が形成されている。結合手段と連結部との間に隔壁部を設けることによって、ガスケットと隔壁部とによって注射筒内の空間と外界とが液密となるので注射筒内の薬剤が外部へ漏出したり薬剤に雑菌が混入したりする心配もない。   FIG. 1 shows a safety prefilled syringe including a syringe barrel 1, a gasket 2, a plunger 3, and a lid member 4. The syringe barrel 1 has a hollow and substantially cylindrical shape, and has a connecting portion 11 having a flow path at the distal end and an opening at the proximal end. The connecting portion 11 is provided with a rib 111, and the flow path is closed by a detachable lid member 4. Inside the syringe barrel 1, a gasket 2 is stored in a liquid-tight manner and slidable in the axial direction of the syringe barrel 1, and a drug solution is contained in a space 15 surrounded by the syringe barrel 1, the gasket 2, and the lid member 4. . A cylindrical body 21 provided with an annular rib on the inner wall of the distal end as a coupling means is formed integrally with the gasket at the distal end of the gasket 2, and a fitting recess 24 is provided at the proximal end. Here, the cylindrical body 21 formed at the gasket tip is formed coaxially with the connecting portion 11 formed in the syringe barrel 1. A partition wall portion 23 is formed between the cylinder body 21 and the fitting recess 24, and the partition wall portion 23 separates the tube body 21 whose tip is reduced in diameter from the fitting recess 24 which is the connecting portion 20. The inside of the syringe barrel and the outside are liquid-tight. A plunger 3 provided with a fitting convex portion 32 that can be fitted to the fitting concave portion 22 is attached to the gasket 2, and the plunger is a cutting means 33 for separating the plunger from the syringe barrel. A notch 331 is formed. By providing a partition wall between the coupling means and the connecting portion, the gasket and the partition wall make the space in the syringe barrel and the outside world liquid-tight. There is no worry of getting mixed in.

ガスケット２とプランジャー３との連結部２０の構造は、ガスケット２とプランジャー３との連結が可能であれば特に限定されるものではなく、ガスケット２とプランジャー３との連結の解除が不能な構造であってもかまわない。図２（ａ）のようにガスケット２の基端に嵌合凹部２４を形成し、プランジャー３の先端にガスケット２の嵌合凹部２４と嵌合する嵌合凸部３２を形成して嵌合させることで連結させてもよいし、図２（ｂ）のようにガスケットに雌ねじ２２を形成し、プランジャー３にガスケット２の雌ねじ２２と螺合可能な雄ねじ３１を形成して螺合させて連結させてもよい。連結部２０を雄ねじ３１と雌ねじ２２の螺合にした場合は連結部２０が切離手段３３を兼ねることができ、プレフィルドシリンジ製造の際にも注射筒に打栓したガスケットにプランジャーを連結することが容易である。   The structure of the connecting portion 20 between the gasket 2 and the plunger 3 is not particularly limited as long as the gasket 2 and the plunger 3 can be connected, and the connection between the gasket 2 and the plunger 3 cannot be released. It may be a simple structure. As shown in FIG. 2A, a fitting recess 24 is formed at the base end of the gasket 2, and a fitting projection 32 that fits with the fitting recess 24 of the gasket 2 is formed at the tip of the plunger 3. As shown in FIG. 2B, a female screw 22 is formed on the gasket, and a male screw 31 that can be screwed with the female screw 22 of the gasket 2 is formed on the plunger 3 and screwed together. You may connect. When the connecting portion 20 is screwed between the male screw 31 and the female screw 22, the connecting portion 20 can also serve as the separating means 33, and the plunger is connected to the gasket plugged into the syringe barrel when the prefilled syringe is manufactured. Is easy.

切離手段３３はガスケット２とプランジャー３とが分離可能であればどんな構造であってもよく、例えば切欠き３３１を設けてプランジャー３を折ることが可能な構造や、点線状に切り込みとヒンジ部とを交互に設けてプランジャーを捩切る構造などがある。ガスケット２とプランジャー３との連結が螺合であるような、連結部２０が切離手段３３を兼ねている構造であっても連結部２０とは別に切離手段３３を設けてもかまわない。   The cut-off means 33 may have any structure as long as the gasket 2 and the plunger 3 can be separated. For example, a structure in which the notch 331 is provided and the plunger 3 can be broken, There is a structure in which hinges are alternately provided and the plunger is twisted. Even if the connecting portion 20 also serves as the separating means 33 such that the connection between the gasket 2 and the plunger 3 is screwed, the separating means 33 may be provided separately from the connecting portion 20. .

ガスケット２が注射筒１の基端の開口部から脱落するのを防ぐために、注射筒１に係止部を設けてもよい。係止部の形状及び材質は、ガスケット２が注射筒１から脱落が防止できればどんなものでもよく、例えば注射筒１の開口部付近に環状の凸部を注射筒１と一体成型してもよいし、また、注射筒１と別部材の係止部を形成して注射筒１に嵌め込んでもよい。   In order to prevent the gasket 2 from dropping from the opening at the proximal end of the syringe barrel 1, a locking portion may be provided on the syringe barrel 1. The shape and material of the locking portion may be anything as long as the gasket 2 can be prevented from falling off the syringe barrel 1. For example, an annular convex portion may be integrally formed with the syringe barrel 1 near the opening of the syringe barrel 1. Alternatively, a locking portion that is a separate member from the syringe 1 may be formed and fitted into the syringe 1.

ガスケット２は、ゴム弾性体であり、材質として通常のシリンジ用ガスケットで用いられるゴム弾性を示す樹脂を用いることができる。前記ゴム弾性体は液密であることから、ブチルゴム、シリコーンゴム、熱可塑性エラストマー、シリコーンエラストマー等を用いることができる。また、注射筒１及びプランジャー３は、シリンジに用いることができれば特に限定されるものではなく、公知の材質を用いることができるが、成型が容易であることから熱可塑性樹脂が好ましい。   The gasket 2 is a rubber elastic body, and a resin exhibiting rubber elasticity used in a normal syringe gasket can be used as a material. Since the rubber elastic body is liquid-tight, butyl rubber, silicone rubber, thermoplastic elastomer, silicone elastomer, or the like can be used. In addition, the syringe barrel 1 and the plunger 3 are not particularly limited as long as they can be used for a syringe, and a known material can be used, but a thermoplastic resin is preferable because it is easy to mold.

ガスケット２の結合手段２１の材質及び形状は使用中に結合手段２１が破損したり結合手段２１とガスケット２とが分離したりしないものであって、後述の被結合手段６１と結合可能であれば特に限定されるものではなく、図３（ａ）の様に結合手段２１１とガスケット２とが一体形成されていてもよいし、図３（ｂ）の様に結合手段２１２とガスケット２とが別体であり、結合手段２１２をガスケット２に嵌め込んだ形状でもよい。結合手段２１２とガスケット２とが別体の場合は、結合手段２１２のガスケット２への装着方法は使用中に外れないものであれば特に限定されない。   The material and shape of the coupling means 21 of the gasket 2 are such that the coupling means 21 is not damaged during use or the coupling means 21 and the gasket 2 are not separated, and can be coupled to the coupled means 61 described later. The coupling means 211 and the gasket 2 may be integrally formed as shown in FIG. 3 (a), or the coupling means 212 and the gasket 2 may be separated as shown in FIG. 3 (b). It may be a body and may have a shape in which the coupling means 212 is fitted into the gasket 2. When the coupling means 212 and the gasket 2 are separate, the mounting method of the coupling means 212 to the gasket 2 is not particularly limited as long as it does not come off during use.

図４は注射針５と針基６を含む針本体と、針基蓋部材７と針カバー８とからなる針組立体である。針本体は先端が注射針５であって、注射針５には基端に注射針と連通する流路を備えた針基６の先端が固着し、針基６の基端には左右に上爪６２と下爪６３を備えた被結合手段６１が設けられている。針基蓋部材７は先端に注射針５が挿通可能な孔７２を有し、孔７２の基端側には針基６が嵌合する針基嵌合部７１が設けられ、基端は開口している。孔７２には注射針５が挿通されて針基嵌合部７１には針基６の先端が嵌合し、針基嵌合部７１に針基６の先端が嵌合することで針基蓋部材７の先端側が閉塞する。針カバー８は先端が閉塞し基端が開口し、針カバー８の基端が針基蓋部材７の先端側に嵌合することで注射針５は針カバー８によって覆われている。針基６の径は注射針５より大きいために針本体が針基蓋部材７の先端の孔７２を貫通することは不可能であり、針本体は針基蓋部材７の基端方向に離脱可能となっている。また、針基６の先端と針基嵌合部７１との嵌合は容易に外れるものではないため、不用意に針本体が針基蓋部材７と分離することはない。   FIG. 4 shows a needle assembly including a needle body including an injection needle 5 and a needle base 6, a needle base cover member 7 and a needle cover 8. The distal end of the needle body is an injection needle 5, and the distal end of a needle base 6 having a flow path communicating with the injection needle is fixed to the proximal end of the injection needle 5. A coupled means 61 having a claw 62 and a lower claw 63 is provided. The needle base cover member 7 has a hole 72 through which the injection needle 5 can be inserted, and a needle base fitting portion 71 into which the needle base 6 is fitted is provided on the base end side of the hole 72. The base end is open. is doing. The injection needle 5 is inserted into the hole 72, the tip of the needle base 6 is fitted to the needle base fitting portion 71, and the tip of the needle base 6 is fitted to the needle base fitting portion 71, so that the needle base lid The distal end side of the member 7 is closed. The needle cover 8 has its distal end closed and its proximal end opened, and the needle cover 8 is covered with the needle cover 8 by fitting the proximal end of the needle cover 8 to the distal end side of the needle base cover member 7. Since the diameter of the needle base 6 is larger than the injection needle 5, it is impossible for the needle body to pass through the hole 72 at the distal end of the needle base cover member 7, and the needle body is detached in the proximal direction of the needle base cover member 7. It is possible. Further, since the fitting between the tip of the needle base 6 and the needle base fitting portion 71 is not easily disengaged, the needle body does not inadvertently separate from the needle base cover member 7.

針基６の基端に設けられる被係合手段６１の形状及び材質は、上記ガスケット２の係合手段２１と係合可能であって、保管時及び使用時に針基６から分離することがなければ特に限定されるものではない。図５（ａ）のように針基６と被係合手段６１１とを一体に形成してもよく、図５（ｂ）のように針基６と被係合手段６１２を別に形成し、針基６と被係合手段６１２とを結合させてもよい。   The shape and material of the engaged means 61 provided at the proximal end of the needle base 6 can be engaged with the engaging means 21 of the gasket 2 and must not be separated from the needle base 6 during storage and use. There is no particular limitation. The needle base 6 and the engaged means 611 may be integrally formed as shown in FIG. 5A, or the needle base 6 and the engaged means 612 are separately formed as shown in FIG. The base 6 and the engaged means 612 may be combined.

図６は本発明のプレフィルドシリンジＡと針組立体Ｂとからなるプレフィルドシリンジ組立体Ｃである。注射筒１より蓋部材４を外して針組立体Ｂの針基蓋部材７の基端側を接続部１１に装着する。このとき、針組立体Ｂの上爪６２は注射筒１の接続部１１に形成されたリブ１１１に係合し、針本体が注射筒の基端方向に移動しないようになっている。針基６は針基蓋部材７の先端の針基嵌合部７１に嵌合した状態であるので、針基蓋部材７の先端は閉塞されているため針基蓋部材７から液が漏れ出すことはなく、使用の際には注射針５以外から液が出ることはない。   FIG. 6 shows a prefilled syringe assembly C comprising the prefilled syringe A and the needle assembly B of the present invention. The lid member 4 is removed from the syringe barrel 1 and the proximal end side of the needle base lid member 7 of the needle assembly B is attached to the connection portion 11. At this time, the upper claw 62 of the needle assembly B is engaged with the rib 111 formed in the connection portion 11 of the syringe barrel 1 so that the needle body does not move in the proximal direction of the syringe barrel. Since the needle base 6 is in a state of being fitted to the needle base fitting portion 71 at the tip of the needle base cover member 7, the tip of the needle base cover member 7 is closed, so that the liquid leaks from the needle base cover member 7. In use, no liquid comes out from other than the injection needle 5.

針基蓋部材７と接続部１１の装着方法についても特に限定されるものではない。針基蓋部材７の基端が接続部１１に被さることで係合してもよいし、接続部１１にネジ溝を形成して針基蓋部材７の内側に接続部１１のネジ溝と螺合可能なネジ山を形成して螺合してもよいし、接続部１１を二重円管状にして外管内側に雌ねじを設けた形状とし、針基蓋部材７に雌ねじと螺合可能な突部を設けて針基蓋部材を螺入して係合させてもよい。   The method for attaching the needle base cover member 7 and the connecting portion 11 is not particularly limited. The base end of the needle base cover member 7 may be engaged by covering the connection part 11, or a screw groove may be formed in the connection part 11 so that the screw groove and screw of the connection part 11 are formed inside the needle base cover member 7. The connecting portion 11 may be formed in a double circular tube shape and provided with a female screw inside the outer tube, and the needle base cover member 7 can be screwed with the female screw. A protrusion may be provided and the needle base cover member may be screwed into engagement.

図７を用いて本発明のプレフィルドシリンジ組立体Ｃの薬液投与後の処理方法について説明する。患者から注射針５を抜き、プランジャー３１を注射筒１の先端方向へ押し込みガスケット２の筒体２１１を接続部１１の流路に侵入させ、ガスケットの筒状体２１１を被結合手段６１１の下爪６３に圧接し、下爪６３とガスケットに形成された筒体２１１のリブとを係合させることによって、爪の左右の間隔が狭められて針本体の上爪６２と注射筒１の接続部１１に形成されたリブ１１１との係合が外れ、針本体とガスケット２とが一体化することによって、針本体がガスケット２と一緒に摺動操作可能となる。その後プランジャー３を引き、針本体とガスケット２とを注射筒１の内部に収納し、プランジャー３の切離手段３３である切欠き３３１でプランジャー３を折ることによってプランジャー２とガスケット３とを分離する。このように本発明のプレフィルドシリンジ組立体を用いると、プランジャーを押し込んでガスケットと針本体を圧接させることによって針本体と注射筒との係合を外してガスケットと針本体を係合させることができ、プランジャーを切離手段によってガスケットと分離させることでガスケットの摺動を不可能とし、注射筒内にガスケットとガスケットに係合した針部を残留して安全に廃棄することが可能である。特にガスケットとプランジャーとの連結が螺合である場合は連結部が切離手段を兼ねているため螺合を解除することでガスケットとプランジャーとの分離が可能である。最後に注射筒の接続部に蓋部材を装着して廃棄するのもよい。   The processing method after chemical | medical solution administration of the prefilled syringe assembly C of this invention is demonstrated using FIG. The injection needle 5 is pulled out from the patient, the plunger 31 is pushed in the direction of the distal end of the syringe barrel 1, the tubular body 211 of the gasket 2 is inserted into the flow path of the connecting portion 11, and the tubular body 211 of the gasket is placed under the coupling means 611. By pressing the nail 63 and engaging the lower nail 63 and the rib of the cylinder 211 formed on the gasket, the space between the left and right of the nail is narrowed, and the connection part between the upper nail 62 of the needle body and the injection cylinder 1 11 is disengaged from the rib 111 and the needle body and the gasket 2 are integrated, so that the needle body can be slid together with the gasket 2. Thereafter, the plunger 3 is pulled, the needle body and the gasket 2 are accommodated in the syringe barrel 1, and the plunger 3 is folded at the notch 331 which is the separating means 33 of the plunger 3, whereby the plunger 2 and the gasket 3 are folded. And are separated. As described above, when the prefilled syringe assembly of the present invention is used, the plunger and the needle main body can be disengaged by pushing the plunger to press the gasket and the needle main body, thereby engaging the gasket and the needle main body. The plunger can be separated from the gasket by the separating means so that the sliding of the gasket is impossible, and the needle portion engaged with the gasket and the gasket remains in the syringe barrel and can be safely discarded. . In particular, when the gasket and the plunger are connected to each other by screwing, the connecting portion also serves as a separating means, so that the gasket and the plunger can be separated by releasing the screwing. Finally, a lid member may be attached to the connecting portion of the syringe barrel and discarded.

ガスケット２の結合手段２１と針本体の被結合手段６１との結合状態について、ガスケット２を注射筒１の先端方向へ押し込み、ガスケット２を針本体の被結合手段６１に接することによって結合手段２１と被結合手段６１とが結合し、接続部１１と針本体との結合が解除されて針本体とガスケット２とが注射筒１の内部に収納可能となるものであれば、特に限定されるものではなく、場合によっては接続部１１にリブ１１１以外の別の構造を設けてもよいし、接続部１１に何も設けなくてもよい。例えば、ガスケット２の係合手段２１と針本体の被係合手段６１とを、それぞれが圧接すると結合する程度の磁力をもつ磁性体で形成してもよい。   With respect to the coupling state of the coupling means 21 of the gasket 2 and the coupled means 61 of the needle body, the gasket 2 is pushed in the direction of the distal end of the syringe barrel 1 and the gasket 2 is brought into contact with the coupled means 61 of the needle body. It is not particularly limited as long as the coupling means 61 is coupled and the coupling between the connecting portion 11 and the needle body is released and the needle body and the gasket 2 can be stored inside the syringe barrel 1. In some cases, the connecting portion 11 may be provided with another structure other than the rib 111, or nothing may be provided in the connecting portion 11. For example, the engaging means 21 of the gasket 2 and the engaged means 61 of the needle body may be formed of a magnetic material having a magnetic force that can be combined when they are in pressure contact with each other.

本発明のプレフィルドシリンジは上述のように、結合手段と連結部との間に隔壁部を設けることで液密が達成でき、使用後に針が収納できる構造となるため、ガスケットからの液漏れや注射筒内への雑菌の混入の心配がなく使用後の誤穿刺が防止できるため医療に好適に用いることができる。
As described above, the prefilled syringe of the present invention can achieve liquid tightness by providing a partition wall between the coupling means and the connecting portion, and has a structure in which the needle can be stored after use. Since there is no worry of contamination of germs in the cylinder and erroneous puncture after use can be prevented, it can be suitably used for medical treatment.

Claims (12)

先端に接続部を有し、かつ基端が開口した注射筒と、前記接続部を封止でき、かつ着脱自在な蓋部材と、前記注射筒内に液密に摺動自在に設けられたガスケットと、前記ガスケットの基端に連結するプランジャーとを含む、前記注射筒内に薬剤が充填されたプレフィルドシリンジであって、前記ガスケットは先端部に結合手段が設けられるとともに、前記結合手段と前記ガスケットの基端部との間に前記注射筒内部の薬剤を外部から隔離できる隔壁部が設けられたことを特徴とするプレフィルドシリンジ。 A syringe barrel having a connecting portion at the distal end and having an open proximal end, a lid member that can seal the connecting portion and is detachable, and a gasket that is slidably liquid-tightly provided in the syringe barrel And a plunger connected to the proximal end of the gasket, the prefilled syringe filled with a medicine in the syringe barrel, the gasket is provided with a coupling means at the distal end, the coupling means and the A prefilled syringe, characterized in that a partition wall is provided between the base end portion of the gasket and the medicine inside the syringe barrel can be isolated from the outside. 前記接続部の前記蓋部材と交換可能に取付けられる針組立体であって、注射針と、前記注射針の基端に固着され、基端に前記結合手段に結合される被結合手段が設けられた針基と、前記注射針が挿通し、前記針基を先端方向に嵌合可能かつ基端方向に離脱可能な針基蓋部材とを含むことを特徴とする針組立体。 A needle assembly that is replaceably attached to the lid member of the connecting portion, and is provided with an injection needle and a coupled means that is fixed to the proximal end of the injection needle and coupled to the coupling means at the proximal end. A needle assembly comprising: a needle base; and a needle base cover member through which the injection needle is inserted, the needle base can be fitted in the distal direction, and can be detached in the proximal direction. 請求項１記載のプレフィルドシリンジと、請求項２記載の針組立体とを含むことを特徴とするプレフィルドシリンジ組立体。 A prefilled syringe assembly comprising the prefilled syringe according to claim 1 and the needle assembly according to claim 2. 前記結合手段が、前記被結合手段に結合するように、前記ガスケットの先端に形成された結合部であることを特徴とする請求項１に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 1, wherein the coupling means is a coupling portion formed at a tip of the gasket so as to couple to the coupled means. 前記結合手段が、前記ガスケットの先端に取付けられ、前記被結合手段に結合される結合部材であることを特徴とする請求項１に記載のプレフィルドシリンジ。 2. The prefilled syringe according to claim 1, wherein the coupling means is a coupling member attached to a tip of the gasket and coupled to the coupled means. 前記接続部内部に、前記針基の基端方向への移動を制限する係合部を設けたことを特徴とする請求項１に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 1, wherein an engagement portion that restricts movement of the needle base in the proximal direction is provided inside the connection portion. 前記ガスケット基端および前記プランジャー先端に、前記ガスケットと前記プランジャーとが連結される連結部が設けられることを特徴とする請求項１に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 1, wherein a connecting portion for connecting the gasket and the plunger is provided at the gasket base end and the plunger tip. 前記連結部が、前記ガスケットと前記プランジャーとが連結可能かつ連結解除不能となるように設けられた嵌合凸部および嵌合凹部であることを特徴とする請求項７に記載のプレフィルドシリンジ。 The prefilled syringe according to claim 7, wherein the connecting portion is a fitting convex portion and a fitting concave portion provided so that the gasket and the plunger can be connected and cannot be released. 前記被結合手段が、前記結合手段に結合するように、前記針基の基端に形成した被結合部であることを特徴とする請求項２に記載の針組立体。 The needle assembly according to claim 2, wherein the coupled means is a coupled portion formed at a proximal end of the needle base so as to be coupled to the coupling means. 前記被結合手段が、前記針基の基端に取付けられ、前記結合手段に結合する前記被結合部材であることを特徴とする請求項２に記載の針組立体。 The needle assembly according to claim 2, wherein the coupled means is the coupled member attached to the proximal end of the needle base and coupled to the coupling means. 前記プランジャーの前記連結部基端側を切離し可能とする切離手段が設けられていることを特徴とする請求項１、７、８に記載のプレフィルドシリンジ。 9. The prefilled syringe according to claim 1, 7, or 8, further comprising a separating unit that can separate the base end side of the connecting portion of the plunger. 10. 前記切離手段が、前記プランジャー側部に設けられた切欠きであることを特徴とする請求項１１に記載のプレフィルドシリンジ。
The prefilled syringe according to claim 11, wherein the separating means is a notch provided in a side portion of the plunger.
JP2007531036A 2005-08-19 2006-08-18 Safety prefilled syringe Expired - Fee Related JP5163123B2 (en)

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