JP2004065461A

JP2004065461A - Syringe for kit product, intermediate slide valve for syringe type kit preparation, syringe type kit preparation, and x-ray contrast preparation kit preparation

Info

Publication number: JP2004065461A
Application number: JP2002227692A
Authority: JP
Inventors: Tetsuo Tokawa; 東川　哲郎; Hideo Akiyama; 秋山　英郎; Kazuo Yanagisawa; 柳沢　一夫
Original assignee: VEKUSON KK; Hisamitsu Pharmaceutical Co Inc
Current assignee: VEKUSON KK; Hisamitsu Pharmaceutical Co Inc
Priority date: 2002-08-05
Filing date: 2002-08-05
Publication date: 2004-03-04
Anticipated expiration: 2022-08-05
Also published as: JP3976635B2

Abstract

<P>PROBLEM TO BE SOLVED: To provide a syringe for a kit preparation with which a plurality of agents can surely be injected in order by once injecting operation, which is good in operability, which has low possibility of inclusion of foam when replenishing the agents, and in which a dead volume which causes an agent without contributing to injection is extremely small, and to provide an intermediate slide valve which realizes the syringe for the kit preparation. <P>SOLUTION: The intermediate slide valve is nearly cylindrical and has recessed parts for forming spaces divided watertight with the inner wall of a syringe barrel when being inserted to the inside of the syringe barrel on its side face. Independently from the recessed part, the intermediate slide valve is provided with a rear agent path reaching the side of a head more than a recess part on the side of the head most in the moving direction of the intermediate slide valve among the recesses on a surface in contact with the inner wall of the syringe barrel on the side face of the intermediate slide valve from a space in the syringe barrel on the plunger operating side of the intermediate slide valve formed when the intermediate slide valve is inserted to the inside of the syringe barrel. <P>COPYRIGHT: (C)2004,JPO

Description

【０００１】
【発明の属する技術分野】
本発明は、内部に中間摺動弁を摺動可能に有し、かつ該中間摺動弁のプランジャ操作側の注射筒内に他の摺動弁（プランジャ摺動弁あるいは他の中間摺動弁）とともに形成する空間にあらかじめ充填された薬液を有する注射器型キット製剤、そのようなキット製剤を可能とするキット製剤注射器及び注射器型キット製剤用中間摺動弁、及び、Ｘ線造影剤用キット製剤に関する。
【０００２】
【従来の技術】
注射器型キット製剤は必要な薬液が予め注射筒内に充填されているため、迅速な操作が可能であるのみならず、従来の注射のようにアンプルやバイアルから薬液を注射筒内へ吸い上げる必要がないため、ガラス粉やゴム片などの夾雑物の混入のおそれが全くなく、また、感染などの医療事故を予め防止できるなどの利点を多く持つ優れた技術である。
【０００３】
ここで、例えば、治療には物理的、化学的あるいは薬理学的特性の異なる２種類以上の薬剤が必要であるが、これらの薬剤が安定性確保等の問題で混合液とすることができないもの（例えば酸性薬剤とアルカリ性薬剤との組み合わせ等）、あるいは、治療薬（第２の薬液）の注射の際に投与部位にはげしい痛みを与えるため、その除痛の目的で第２の薬液の投与の前に予め局所麻酔剤を第１の薬液として投与するものなどが知られている。
【０００４】
このうち、後者の例として変形性膝関節症、肩関節周囲炎などの、第１の薬液が例えば塩酸リドカインなどの局所麻酔剤と、注射針の太さの影響、ｐＨや浸透圧比が体液と大きく異なり、また、医師の拙劣手技等の理由により患者の患部に激痛を与えるおそれのあるヒアルロン酸ナトリウムなどの治療剤などと、あるいは、世界中で汎用されているものの、静脈血管に激痛を与えることが知られている導入麻酔剤（プロポフォール）などとの組み合わせがその典型的な事例として考えられる。
【０００５】
このような注射器型キット製剤として、本発明者等による、１回の注射操作で２種類以上の薬剤を混合することなく、順次注射することができる直列順次分注型注射器を用いた注射器型キット製剤について説明する。
【０００６】
図１（ａ）は２種類の薬剤を１回の操作で注射することができる直列順次分注型注射器を用いた注射器型キット製剤の例を示すモデル図である。
【０００７】
ここに示されたキット製剤の注射器は一端に注射針接続部１ａを有し、他端のプランジャ操作側端に開口を有する注射筒１内に、１個の中間摺動弁３及び１個のプランジャ摺動弁２とが収められ、注射筒１内部はこれら摺動弁２及び３によりその前後で水密に区画されている。さらに、注射筒１の注射針装着部１ａがエラストマー性を有する素材からなるキャップ４により密栓され、前記中間摺動弁３の注射筒針側空間には第１の薬液５が、中間摺動弁３とプランジャ摺動弁２との間の空間には第２の薬液６がそれぞれ充填されている。この例ではプランジャ摺動弁２には取り外し可能なプランジャ操作部２ａが取り付けられている。
【０００８】
この注射器の注射筒１の側面の注射筒針側端付近には側面壁の一部が注射筒軸に対して放射方向に突出してなる連通通路１ｃが設けられている。
【０００９】
中間摺動弁３’は図２（ａ）に進行方向前方側から、図２（ｂ）に進行方向後方側から見た図を示すように、略円柱状であって、その側面のプランジャ操作側（進行方向後側）には周方向を一周する環状リップ３ａ’が１つ設けられ、この環状リップ３ａ’は注射筒１の内壁に当接し、その注射筒内前後の空間を水密に区画している。一方、中間摺動弁３’側面の注射筒針側（進行方向側）には注射筒１の内壁に当接し、略円柱状の中間摺動弁３’の摺動の際にもその軸線を注射筒１の軸線と一致させるよう保持部３ｂ’が設けられている。この保持部３ｂ’は環状リップ３ａ’とは異なり、中間摺動弁３’の側面を一周するものではなく、中間摺動弁３’の側面の環状リップ３ａ’と保持部３ｂ’との間の空間は、中間摺動弁３’の注射筒針側空間へ連通して一体となっているため、注射筒針側空間と中間摺動弁とプランジャ摺動弁との間の空間と同様に第１の薬液５が充填されている。
【００１０】
ここで、このような形状の中間摺動弁ではなく、環状リップを２つ以上有する中間摺動弁を用いた場合にはそれら中間摺動弁と注射筒１内壁とで形成される密閉空間に空気が閉じこめられ、注射操作により対象者の体内に注射される可能性があるが、このような環状リップを１つだけ有する中間摺動弁によりそのような不都合が回避できる。さらにこの中間摺動弁３’の進行方向底面には凸部３ｃ’が設けられている。
図１（ｂ）は図１（ａ）のＬＬにおける断面図（モデル図）である。
【００１１】
このようなキット製剤は使用に先立ち、図１（ｃ）に示すよう注射筒１の注射針接続部１ａに注射針７が装着される。
【００１２】
このとき、第１の薬液５の部分に注射針装着操作等で気泡が生じた場合、注射針側を上にしてプランジャ操作部２ａを操作することによりその気泡を除去することができる。なお、第１の薬液５の注射量を特に少なくする場合には、この段階でプランジャ操作部２ａを操作して第１の薬液５の量を減らす。
【００１３】
次いで注射針７を要注射部位に刺し、その後プランジャ操作部２ａを注射筒１針装着側に移動させる操作を行って第１の薬液５を注射する（図３（ａ）参照）。
【００１４】
その後、さらにプランジャ操作部２ａの操作を続けると、今度は第２の薬液６が要注射部位に注射される。このとき中間摺動弁３’が注射筒針側に移動して注射筒先端部に達するが、中間摺動弁３’に設けられた前述の凸部３ｃ’が注射筒底部１ｂに当接するため、中間摺動弁３’は注射筒底部１ｂに密着することがなく、さらに連通通路１ｃがバイパスとなるので、これら摺動弁が注射筒底部１ｂ側に移動しても、第２の薬液６の注射針７への供給通路が確保される。
【００１５】
図３（ｂ）はプランジャ操作部２ａの操作が終了し第２の薬液６の注射が終了した状態（注射完了状態）を示す。通常、この状態で要注射部位から注射針を抜くが、第２の薬液６の注射量を少なくする場合には、第２の薬液６が注射筒１内に残った状態で注射針を注射部位から抜いても良い。
【００１６】
このような直列順次分注型注射器型キット製剤において、第１の薬液が局所麻酔剤であって第２の薬液が治療薬の場合、第１の薬液５が注射された部位に第２の薬液６が確実に注射されるため、第２の薬液６が体液に比して、ｐＨ、浸透圧、温度などが大きく異なっていても、痛みのない、あるいは、痛みの少ない注射が可能となる。
【００１７】
しかしながら、このような直列順次分注型注射器にも欠点があった。
すなわち、中間摺動弁の側面と注射筒内面との間の空間はデッドボリュームとなりこの空間に存在する薬液は注射に寄与しない。ここで、注射剤の中には１ｍｌあたり数千円〜数万円するような高価なものもあり、その価格を無視できない場合がある。このことは特にＸ線造影剤のように一回の注射量が１００ｍｌにもなるような場合、大口径の注射器を使う場合に顕著である。
【００１８】
しかしながら、デッドボリュームを小さくするために、保持部３ｂ’を大きくすると、注射筒内壁との接触面積が大きくなり、その結果中間摺動弁の摺動抵抗が大きくなり操作性が著しく劣化する。あるいは、保持部３ｂ’を大きくすることなくデッドボリュームを減らすために、中間摺動弁側面と注射筒内面との間に形成される空間の厚さを薄くすると、キット製剤製造の際の薬液充填時にその空間に空気などの充填時雰囲気ガスが泡となって閉じこめられて容易には除去できず、注射時にそのガスが注射されるおそれが生じ、結果として、不良品が多発し、生産性が低下するのみならず、医薬品であるキット製剤としての信頼性も著しく低下する。
【００１９】
ここで、注射器自体は従来の通常のもの（連通通路を有しないもの）を用い、但し、中間摺動弁に中空部を設け、前液の注射操作が終了したときに後液の圧力によって中間摺動弁の一部が変形して、その側面と注射筒内壁との間に通液路が形成されると云う技術が提案されている（特開平１０−５７４８６号公報、特開平１０−８０４８５号公報）。
【００２０】
しかし、このような中間摺動弁の変形による通液路の形成条件は中間摺動弁に加わる動圧力及び中間摺動弁を形成する材料の柔軟性に依存するため、通液路形成は酷暑地や極寒地での使用時はもちろん、操作者の力のかけ方、薬剤の粘度・温度、あるいは、用いる注射針の太さなどの条件にも左右され、常に誤動作の危険が伴い、その信頼性は著しく低く、１回の注射操作で複数の薬剤を確実に順次注射するという要求性能に充分に対応することができないものであった。
【００２１】
【発明が解決しようとする課題】
本発明は、上記した従来の問題点を改善する、すなわち、１回の注射操作で複数の薬剤を確実に順次注射可能で、操作性が良好であり、薬液充填時での泡の混入の可能性が低く、かつ、注射に寄与しない薬液の原因となるデッドボリュームがきわめて小さいキット製剤用注射器、そのようなキット製剤用注射器を可能とする中間摺動弁を提供することを目的とする。
【００２２】
【課題を解決するための手段】
本発明のキット製剤用注射器は上記課題を解決するため、請求項１に記載の通り、略円柱状であって、その側面に注射筒内に挿入された際に注射筒内壁とともに水密に区画された空間を形成する凹部を有する中間摺動弁であって、該凹部とは独立して、該中間摺動弁が注射筒内に挿入された際に形成される該中間摺動弁プランジャ操作側の注射筒内空間から、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側に至る後方薬液用通路を備えた中間摺動弁を注射筒内部に摺動可能に有し、かつ、
該注射筒の内壁の注射針側端付近に、該中間摺動弁が注射筒内の最も注射針側に達したときに上記中間摺動弁の後方薬液用通路に接続し、かつ、後方薬液用通路に接続したときに、中間摺動弁をバイパスして、中間摺動弁のプランジャ操作側の薬液を該中間摺動弁の注射筒内注射針側に供給可能な連通通路を有するキット製剤用注射器である。
【００２３】
このような構成により、中間摺動弁側面に形成された凹部により摺動抵抗を低減しながら、該凹部と注射筒内壁とによって形成された水密に区画された空間には薬液が充填されないので無駄とならず、さらに、後方薬液用通路は凹部とは独立して設けられているので、この通路内に空気等が混入するおそれがない。
【００２４】
また、この後方薬液用通路の先端は中間摺動弁側面の注射筒内壁に接する面に設けられているので、摺動弁自体が注射筒内を摺動して注射針側端付近に達して後方薬液用通路が注射筒の内壁の注射針側端付近に設けられた連通通路に接続しない限りはこの中間摺動弁進行方向後方の薬液が中間摺動弁の進行方向の前方に供給されることはなく、信頼性が極めて高い。さらに、後方薬液用通路は凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさら先頭側箇所に至っているため、連通通路と凹部とが接続しない状態での連通通路と後方薬液用通路との接続の確保が可能であり、そのとき、凹部と注射筒内壁との空間に存在するガスと連通通路とが接続することがないので、薬液内にガスが混入することが防止されている。
【００２５】
【発明の実施の形態】
本発明における中間摺動弁とは、プランジャによって直接駆動される摺動弁ではなく、進行方向後側の薬液によって間接的に駆動される摺動弁であり、略円柱状であって、その側面に注射筒内に挿入された際に注射筒内壁とともに水密に区画された空間を形成する凹部を有する中間摺動弁であって、該凹部とは独立して、該中間摺動弁が注射筒内に挿入された際に形成される該中間摺動弁プランジャ操作側の注射筒内空間から、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側に至る後方薬液用通路を備えていることが必要である。
【００２６】
このような本発明に係る中間摺動弁の一例αを図４（ａ）〜図４（ｃ）に示す。
図４（ａ）は側面図、図４（ｂ）は摺動弁進行方向後方からの斜視図、図４（ｃ）は摺動弁進行方向前方からの斜視図である。この中間摺動弁αは後方薬液用通路として、この中間摺動弁αが注射筒内に挿入された際に形成されるプランジャ操作側の注射筒内空間に開口する後方薬液入口α１、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部α４（この例では１つだけであるが複数ある場合もある）よりもさらに先頭側箇所に開口する後方薬液出口α２、及び、これら後方薬液入口α１と後方薬液出口α２とを連通する、摺動弁α自体に穿たれた連通孔α３により構成されている。この後方薬液用通路は中間摺動弁の摺動性を向上させる目的で設けられた凹部α４とは独立して設けられている。この例では後方薬液用通路は略円柱状の中間摺動弁αに対して互いに等角度（１２０°）となるように３つ設けられている。なお、後方薬液用通路の断面積は、用いる注射針の内径の断面積に対して同等以上であれば通常充分であり、小さいほど残留する薬液の量は少なくてすむ。
【００２７】
図４（ｄ）〜図４（ｆ）には本発明に係る他の中間摺動弁の例βを示す。
図４（ｄ）は側面図、図４（ｅ）は摺動弁進行方向後方からの斜視図、図４（ｆ）は摺動弁進行方向前方からの斜視図である。
【００２８】
この中間摺動弁βでは、後方薬液用通路β１は、中間摺動弁βの側面に溝状に設けられていて、中間摺動弁の摺動性を向上させる目的で設けられた凹部β２とは独立して設けられており、後方薬液用通路β１の摺動弁β進行方向の先端は凹部β２よりもさらに先頭側に位置している。この例でも後方薬液用通路は略円柱状の中間摺動弁βに対して互いに等角度（１２０°）となるように３つ設けられている。なお、後方薬液用通路の断面積は、用いる注射針の内径の断面積に対して同等以上であれば通常充分であり、小さいほど残留する薬液の量は少なくてすむ。
【００２９】
なお、図４（ｇ）〜図４（ｉ）には、通常のプランジャ摺動弁（プランジャにより直接駆動される摺動弁）γを示した。
図４（ｇ）は側面図、図４（ｈ）は摺動弁進行方向後方からの斜視図、図４（ｉ）は摺動弁進行方向前方からの斜視図である。
【００３０】
このプランジャ摺動弁には、上記摺動弁α及びβ同様に摺動抵抗軽減のために凹部γ１が設けられているが、後方薬液用通路は設けられていない。なお、γ２はプランジャ操作部（図示しない）の注射針側先端の嵌合部に嵌合する嵌合孔である。
【００３１】
上記のような本発明に係る中間摺動弁は図５（ａ）にその断面を、図５（ｂ）にその先端側を斜視図で示すような注射筒１に摺動可能に収納される。
注射筒１はその一端の注射針側底面の中央に注射針接続部１ａを有し、他端のプランジャ操作側端に開口を有する。
【００３２】
注射筒１の内壁の注射針側端付近に、本発明に係る中間摺動弁が注射筒内の最も注射針側に達したときに上記中間摺動弁の後方薬液用通路に接続し、かつ、後方薬液用通路に接続したときに、中間摺動弁をバイパスして、該中間摺動弁のプランジャ操作側の薬液を該中間摺動弁の注射筒内注射針側に供給可能な連通通路１ｃが設けられている。この例では連通通路１ｃは注射筒１内壁周方向を一周するように設けられているが、上述の本発明に係る摺動弁αあるいはβのように、後方薬液用通路１ｄが略円柱状の中間摺動弁に対して互いに等角度（１２０°）となるように３つ設けられている場合には周方向１２０°超（例えば１３０〜１４０°）となるように設けられていれば充分である。
【００３３】
さらにこの注射筒１底面には中間摺動弁が最も注射針側に位置した場合において、後方薬液用通路に接続した連通通路１ｃによって中間摺動弁の注射筒内注射針側（中間摺動弁進行方向前方）に供給された中間摺動弁のプランジャ操作側（中間摺動弁進行方向後方）の薬液を、さらに注射針への液導入孔１ａ１に供給するための溝状の注射針側面液通路１ｄが注射筒１注射針側底面に、略円筒形の注射筒１に対して等角度（９０°）ずつ４つ設けられている。ただし、注射針注射針側面液通路１ｄは１つ設けられていれば通常充分で、またその通路の断面積は用いる注射針の内径の断面積に対して同等以上（好ましくは１．５倍〜２倍程度）であれば通常充分であり、小さいほど残留する薬液の量は少なくてすむ。
【００３４】
図６（ａ）〜図６（ｃ）には併用するプランジャ摺動弁の例２を示した。
図６（ａ）は側面図、図６（ｂ）は摺動弁進行方向後方からの斜視図、図６（ｃ）は摺動弁進行方向前方からの斜視図である。
【００３５】
プランジャ摺動弁進行方向前面は用いる中間摺動弁の進行方向後面の形状に適合させることにより、これら摺動弁の間に残留する薬液の量を少なくすることができる。なお、図６（ｂ）の中間摺動弁の進行方向後面中央に見えるのはプランジャ操作部（図示しない）の注射針側先端の嵌合部に嵌合する嵌合孔（モデル的に示す）である。
【００３６】
上記のような中間摺動弁α、注射筒１及びプランジャ摺動弁２を用いて作製した本発明に係る直列順次分注型注射器を用いた注射器型キット製剤の例を図７（ａ）にモデル断面図で示す。
【００３７】
図７に示されたキット製剤は一端に注射針接続部１ａを有し、他端のプランジャ操作側端に開口を有する注射筒１内に、１個の中間摺動弁α及び１個のプランジャ摺動弁２とが摺動可能に収められ、注射筒１内部はこれら摺動弁α及び２によりその前後で水密に区画されている。さらに、注射筒１の注射針装着部１ａがエラストマー性を有する素材からなるキャップ４により密栓され、前記中間摺動弁αの注射筒針側空間には第１の薬液５が、中間摺動弁αとプランジャ摺動弁２との間の空間には第２の薬液６がそれぞれ充填されている。
【００３８】
このようなキット製剤は使用に先立ち、図７（ｂ）に示すよう注射筒１の注射針接続部１ａに注射針７が装着される（なお注射針７の代わりに、チューブ、活栓類などのアクセサリー類が接続されていても良い）。またプランジャ摺動弁２にはプランジャ操作部２ａが取り付けられる。
【００３９】
このとき、第１の薬液５の部分に注射針装着操作等で気泡が生じた場合、注射針側を上にしてプランジャ操作部２ａを操作することによりその気泡を除去することができる。なお、第１の薬液５の注射量を特に少なくする場合には、この段階でプランジャ操作部２ａを操作して第１の薬液５の量を減らす。
【００４０】
次いで注射針７を要注射部位に刺し、その後プランジャ操作部２ａを注射筒１注射針側に移動させる操作を行って第１の薬液５を注射する（図７（ｃ）参照）。
【００４１】
その後、さらにプランジャ操作部２ａの操作を続けると、今度は第２の薬液６が要注射部位に注射される。このとき中間摺動弁αが注射筒注射針側に移動して注射筒先端部（最も注射針側）に達する（図８（ａ）参照）。
【００４２】
このとき、中間摺動弁αの後方薬液用通路の後方薬液出口α２は、注射筒１の内壁の注射針側端付近に設けられた連通通路１ｃに接続し、さらに連通通路１ｃは注射筒１注射針側底面に設けられた注射針側面液通路１ｄに接続しているため、中間摺動弁αのプランジャ操作側空間の後方薬液６は後方薬液用通路の後方薬液入口α１から連通孔α３及び後方薬液出口α２、連通通路１ｃ、注射針側面液通路１ｄを経て注射針へ導入される。なお、中間摺動弁αが注射筒１先端部に達していないときには後方薬液出口α２は注射筒１内面によって密封されているために中間摺動弁αのプランジャ操作側空間の後方薬液６の中間摺動弁の注射筒内注射針側への移動は生じない。
【００４３】
図９はプランジャ操作部２ａの操作が終了し第２の薬液６の注射が終了した状態（注射完了状態）を示す。通常、この状態で要注射部位から注射針を抜くが、第２の薬液６の注射量を少なくする場合には、第２の薬液６が注射筒１内に残った状態で注射針を注射部位から抜いても良い。
【００４４】
このような直列順次分注型注射器型キット製剤において、第１の薬液が局所麻酔剤であって第２の薬液が治療薬の場合、第１の薬液５が注射された部位に第２の薬液６が確実に注射されるため、第２の薬液６が体液に比して、ｐＨ、浸透圧、温度などが大きく異なっていても、痛みのない、あるいは、痛みの少ない注射が可能となる。
【００４５】
なお、上記では本発明に係る中間摺動弁αを用いた例を説明したが、本発明に係る中間摺動弁βを用いた場合であっても操作は同様であり、ただし図８（ａ）を用いた説明での、中間摺動弁αのプランジャ操作側空間の後方薬液６は後方薬液用通路の後方薬液入口α１から連通孔α３及び後方薬液出口α２、連通通路１ｃ、注射針側面液通路１ｄを経ての注射針へ導入が、図８（ｂ）に示すように、この中間摺動弁βの側面に設けられた溝状の後方薬液用通路β１、連通通路１ｃ、注射針側面液通路１ｄを経ての注射針への導入となる。
【００４６】
また、本発明に係る中間摺動弁αにより後方薬液用通路として中間摺動弁自体を穿った連通孔による中間摺動弁の後方液の導入の例、本発明に係る中間摺動弁βでは後方薬液用通路として中間摺動弁側面に設けられた溝による中間摺動弁の後方液の導入の例をそれぞれ示したが、例えば図１０（ａ）及び図１０（ｂ）に示すような、後方薬液用通路として溝と連通孔との併用（溝と連通孔との順序は逆であっても良い）による中間摺動弁の後方液の導入を行っても良く、その場合も当然本発明に含まれる。
【００４７】
本発明において中間摺動弁の注射筒内の移動はその後方薬液を介して加えられる圧力によって生じるが、後方薬液用通路が注射筒内壁の注射針側端付近に設けられた連通通路に接続した瞬間にその圧力が急激に低下するため、後方薬液用通路と連通通路との接続箇所の断面積が用いる注射針の内断面積に比べ同程度以上に大きくならない前に中間摺動弁の移動が止まってしまい、それ以降のプランジャの操作にはきわめて大きな力が必要となる場合がある。
【００４８】
このような不都合を解消するために、後方薬液用通路の中間摺動弁進行方向の最も先頭側に、その後方薬液用通路を摺動弁側面周方向に拡大する拡大部を設けることが望ましい。
【００４９】
このような中間摺動弁の例を図１１（ａ）〜（ｆ）に示す。
図１１（ａ）〜図１１（ｃ）に本発明に係る中間摺動弁の一例αに後方薬液用通路を摺動弁側面周方向に拡大する拡大部α５’を設けたα’を、図１１（ｄ）〜図１１（ｆ）に本発明に係る中間摺動弁の一例βに後方薬液用通路を摺動弁側面周方向に拡大する拡大部β３’を設けたβ’を示す。これら図中符号は「’」を付けない図４（ａ）〜図４（ｆ）中の符号にそれぞれ対応する。
【００５０】
また、上記で用いた注射筒１にはその注射針側底面に溝状の注射針側面液通路１ｄが設けられていたが、溝状の注射針側面液通路を注射筒の注射針側底面に設けず、例えば、中間摺動弁の進行方向前方側面に溝状の注射針側面液通路を設けても良く、そのような中間摺動弁の例を図１２（ａ）〜（ｆ）に示す。
【００５１】
図１２（ａ）〜図１２（ｃ）に本発明に係る中間摺動弁の一例αに中間摺動弁の進行方向前方側面に溝状の注射針側面液通路α６”を設けたα”を、図１２（ｄ）〜図１２（ｆ）に本発明に係る中間摺動弁の一例βに中間摺動弁の進行方向前方側面に溝状の注射針側面液通路β４”を設けたβ”を示す。これら図中符号は「”」をつけない図４（ａ）〜図４（ｆ）中の符号にそれぞれ対応する。
【００５２】
これら中間摺動弁の進行方向前方側面に設けられた溝状の注射針側面液通路により、上記中間摺動弁が注射筒内の最も注射針側に達し、その注射針側面が注射筒注射針側底面に密着した際にも、注射筒の内壁の注射針側端付近に設けられた上記連通通路と注射筒注射針側底面に設けられた注射針への液導入孔との間の液流が確保される。なお、注射針側面液通路の断面積は用いる注射針の内径断面積と同等以上であることが望ましいが、大きすぎると薬液が無駄になるので注射針の内径断面積の同等以上２倍以下で充分であり、また上記例ではそれぞれ注射針側面液通路が３つあるが、１つあれば通常は充分である。
【００５３】
また、溝状の注射針側面液通路の代わりに、中間摺動弁が最も注射針側に移動した場合であっても、注射筒の注射針側底面に密着せず、連通通路から注射針への液流が確保されるように中間摺動弁の進行方向前方側面に凸部を設けても良く、そのような例を図１３（ａ）〜（ｃ）に示す。中間摺動弁β”’は記中間摺動弁が注射筒内の最も注射針側に達したときにも注射筒注射針側底面への密着を防止する密着防止凸部β５”’が上記中間摺動弁βの中間摺動弁の進行方向前方側面に設けてある。しかし、密着防止凸部による液通路確保は上記の他の例よりもデッドボリュームが大きくなりやすく、そのとき無駄となる薬液量が多くなる。
【００５４】
ここで、上記のようなキット製剤用注射器の応用例として、Ｘ線造影剤用キット製剤が挙げられる。
すなわち、注射筒内に挿入された中間摺動弁あるいはプランジャ摺動弁によって水密に区画された２つ以上の空間にあらかじめそれぞれ薬液が充填され、該薬液がプランジャの操作によって混合されることなく順次排出される直列順次分注型注射器を用いるキット製剤において、１つの薬液がＸ線造影剤を有する薬液であり、かつ、該Ｘ線造影剤を有する薬液の排出後にＸ線造影剤を有しない薬液が排出されるＸ線造影剤キット製剤である。
【００５５】
このとき上記Ｘ線造影剤を有しない薬液が生理食塩水、生理食塩水以外の血液代用剤、ビタミン剤、蒸留水から選ばれる１種、または２種以上の混合物であることにより様々な効果が得られる。
【００５６】
例えば、図７に示されたキット製剤において、第１の薬液５としてＸ線造影剤を７０ｍＬ充填し、第２の薬液として生理食塩水、生理食塩水以外の血液代用剤、ビタミン剤、蒸留水から選ばれる１種、または２種以上の混合物３０ｍＬを充填する。ここで、血液代用剤として、例えば、生理食塩水、塩化ナトリウム注射液、デキストラン注射液、塩化アンモニウム注射液、塩化カリウム注射液、ヒドロキシエチルデンプン注射液、リン酸二カリウム注射液、開始液（塩化ナトリウム・ブドウ糖剤等）、ブドウ糖・デキストラン剤、維持液（乳酸ナトリウム・無機塩類・糖類剤）、術後回復液、脱水補給液、酢酸リンゲル液、リンゲル液、マンニトール配合剤などが挙げられる。すなわち、第２の薬剤としては医薬・生理学的に大きな効果は必要はなく、その主たる目的は、以下の３つである。
【００５７】
１．Ｘ線造影剤はエクステンションチューブやカテーテルを介して対象者の体内に導入されることが多い。そのチューブ、カテーテルの内容積がデッドボリュームとなり、薬液が残留する。そのため、キット製剤の場合には体内に導入する必要量にデッドボリューム分を加えた量を充填する必要が出てくる。しかしながら、Ｘ線造影剤は１００ｍｌあたり約２万円と非常に高価であり、余分に充填することは経済的ではない。ここで第１の薬液のＸ線造影剤として、対象者体内に導入する必要量のみを充填し、第２の薬液として体内（あるいは血管内）に導入されたとしても医薬・生理学的に差し支えないものを選択し、チューブ内に残留する第１液を含めた必要量全部を対象者体内に「押し出す」ことが可能となる。
【００５８】
なお、Ｘ線造影剤の導入のためのプランジャ操作は、Ｘ線撮影室での操作であるために自動注入器による自動・遠隔制御で行われるが、例えば上記で説明したような直列順次分注型注射器を用いることで、従来の自動注入器による操作が可能であり、新規の自動注入器を購入しなくても良い。
【００５９】
さらに、上記のようにキット製剤であるために薬剤容器の開封、注射筒への吸引等の操作が不要であり、これら操作につきまとう、異物混入、細菌・ウィルス汚染などの心配がなく、また活栓の併用も必要がないので活栓による細菌・ウィルス汚染や、操作ミスなどがあらかじめ防止される。
【００６０】
２．Ｘ線造影剤導入後に静脈内や静脈弁に残留した造影剤が凝固することがあり、血栓性静脈炎を引き起こすおそれがあるが、Ｘ線造影剤導入に速やかに上記のような第２液を導入することによりこれら造影剤の残留を防止する。
【００６１】
３．造影剤の速やかな体内への押し出し（フラッシュ）が可能となって、主要血管係の造影効果の向上や静脈周辺のアーチファクト（虚像）の出現を軽減することが可能となり、これら効果により必要とする造影剤量を減らすことができ、コスト的に有利となるとともに、対象者身体への負担を減少させることができる。
【００６２】
【発明の効果】
本発明のキット製剤用注射器は、１回の注射操作で複数の薬剤を確実に順次注射可能で、操作性が良好であり、薬液充填時での泡の混入の可能性が低く、かつ、注射に寄与しない薬液の原因となるデッドボリュームがきわめて小さい優れたキット製剤用注射器である。
【図面の簡単な説明】
【図１】（ａ）２種類の薬剤を１回の操作で注射することができる直列順次分注型注射器を用いた注射器型キット製剤の従来例を示すモデル図である。
（ｂ）図１（ａ）のＬＬにおける断面図（モデル図）である。
（ｃ）注射針が装着された状態を示す図である。
【図２】従来技術に係る中間摺動弁３’を示す図である
（ａ）進行方向前方側から見た斜視図
（ｂ）進行方向後方側から見た斜視図
【図３】（ａ）第１の薬液５の注射が終了した状態を示す図である。
（ｂ）プランジャ操作部２ａの操作が終了し第２の薬液６の注射が終了した状態（注射完了状態）を示す図である。
【図４】本発明に係る中間摺動弁α及びβと従来技術に係るプランジャ摺動弁γを示す図である。
（ａ）中間摺動弁αの側面図
（ｂ）中間摺動弁αを進行方向後方側から見た斜視図
（ｃ）中間摺動弁αを進行方向前方側から見た斜視図
（ｄ）中間摺動弁βの側面図
（ｅ）中間摺動弁βを進行方向後方側から見た斜視図
（ｆ）中間摺動弁βを進行方向前方側から見た斜視図
（ｇ）プランジャ摺動弁γの側面図
（ｈ）プランジャ摺動弁γを進行方向後方側から見た斜視図
（ｉ）プランジャ摺動弁γを進行方向前方側から見た斜視図
【図５】本発明のキット製剤用注射器で用いる注射筒の例を示す図である。
（ａ）断面図
（ｂ）注射針装着側から見た部分斜視図
【図６】本発明のキット製剤用注射器で用いるプランジャ摺動弁の例を示す図である。
（ａ）側面図
（ｂ）進行方向後方側から見た斜視図
（ｃ）進行方向前方側から見た斜視図
【図７】（ａ）２種類の薬剤を１回の操作で注射することができる本発明に係る直列順次分注型注射器を用いた注射器型キット製剤を示すモデル図である。
（ｂ）注射針７とプランジャ操作部２ａとが装着された状態を示す図である。
（ｃ）第１の薬液５の注射が終了した状態を示す図である。
【図８】（ａ）本発明に係る中間摺動弁αを用いたときの第２の薬液の流れの様子を示す部分拡大断面図である。
（ｂ）本発明に係る中間摺動弁βを用いたときの第２の薬液の流れの様子を示す部分拡大断面図である。
【図９】（ａ）プランジャ操作部２ａの操作が終了し第２の薬液６の注射が終了した状態（注射完了状態）を示す図である。
【図１０】本発明に係る別の摺動弁を示す図である。
（ａ）側面図
（ｂ）進行方向後方側から見た斜視図
【図１１】後方薬液用通路の中間摺動弁進行方向の最も先頭側に該後方薬液用通路を摺動弁側面周方向に拡大する拡大部を有する本発明に係る中間摺動弁α’及びβ’を示す図である。
（ａ）中間摺動弁α’の側面図
（ｂ）中間摺動弁α’を進行方向後方側から見た斜視図
（ｃ）中間摺動弁α’を進行方向前方側から見た斜視図
（ｄ）中間摺動弁β’の側面図
（ｅ）中間摺動弁β’を進行方向後方側から見た斜視図
（ｆ）中間摺動弁β’を進行方向前方側から見た斜視図
【図１２】中間摺動弁の進行方向前方側面に溝状の注射針側面液通路を設けた中間摺動弁α”及びβ”を示す図である。
（ａ）中間摺動弁α”の側面図
（ｂ）中間摺動弁α”を進行方向後方側から見た斜視図
（ｃ）中間摺動弁α”を進行方向前方側から見た斜視図
（ｄ）中間摺動弁β”の側面図
（ｅ）中間摺動弁β”を進行方向後方側から見た斜視図
（ｆ）中間摺動弁β”を進行方向前方側から見た斜視図
【図１３】注射筒内の最も注射針側に達したときにも注射筒注射針側底面への密着を防止する密着防止凸部を有する中間摺動弁β”’を示す図である。
（ａ）側面図
（ｂ）進行方向後方側から見た斜視図
（ｃ）進行方向前方側から見た斜視図
【符号の説明】
１　注射筒
１ａ　注射針接続部
１ｃ　連通通路
２　　プランジャ摺動弁
２ａ　プランジャ操作部
α、β　　本発明に係る中間摺動弁
４　　キャップ
５　　第１の薬液
６　　第２の薬液
７　　注射針[0001]
TECHNICAL FIELD OF THE INVENTION
According to the present invention, an intermediate sliding valve is slidably provided therein, and another sliding valve (plunger sliding valve or another intermediate sliding valve) is provided in an injection cylinder on a plunger operation side of the intermediate sliding valve. ), A syringe-type kit preparation having a drug solution pre-filled in the space formed therewith, a kit preparation enabling such a kit preparation, an intermediate slide valve for the syringe-type kit preparation, and a kit preparation for an X-ray contrast agent About.
[0002]
[Prior art]
The syringe-type kit preparation is pre-filled with the necessary drug solution in the syringe barrel, so not only can it be operated quickly, but also it is necessary to draw up the drug solution from an ampoule or vial into the syringe barrel as in the case of conventional injection. This is an excellent technology that has many advantages such that there is no risk of contamination by foreign substances such as glass powder and rubber fragments, and that medical accidents such as infection can be prevented in advance.
[0003]
Here, for example, treatment requires two or more types of drugs having different physical, chemical or pharmacological properties, but these drugs cannot be used as a mixed solution due to problems such as stability stability. (For example, a combination of an acidic drug and an alkaline drug, etc.) or a therapeutic agent (a second drug solution) may cause severe pain at the administration site upon injection, and therefore, administration of the second drug solution for the purpose of pain relief. It is known that a local anesthetic is previously administered as a first liquid medicine beforehand.
[0004]
Among these, the first drug solution such as knee osteoarthritis and shoulder periarthritis as examples of the latter is a local anesthetic such as lidocaine hydrochloride, and the effect of the thickness of the injection needle, pH and osmotic pressure ratio are the same as body fluid. Significantly different, and with a therapeutic agent such as sodium hyaluronate that may cause severe pain in the affected area of the patient due to poor doctor's procedures, etc. A combination with a known anesthetic (propofol) or the like is considered as a typical example.
[0005]
As such a syringe-type kit preparation, a syringe-type kit using a serial sequential dispensing syringe that can be sequentially injected without mixing two or more kinds of drugs by a single injection operation by the present inventors. The formulation will be described.
[0006]
FIG. 1A is a model diagram showing an example of a syringe-type kit preparation using a serial sequential dispensing syringe capable of injecting two kinds of drugs in one operation.
[0007]
The syringe of the kit preparation shown here has an injection needle connection portion 1a at one end and an intermediate slide valve 3 and an A plunger slide valve 2 is housed therein, and the inside of the syringe barrel 1 is partitioned by these slide valves 2 and 3 in a watertight manner before and after the slide valve. Further, the injection needle mounting portion 1a of the injection cylinder 1 is hermetically sealed by a cap 4 made of a material having an elastomeric property. The space between the plunger slide valve 2 and the plunger slide valve 2 is filled with a second chemical solution 6, respectively. In this example, a detachable plunger operating section 2a is attached to the plunger sliding valve 2.
[0008]
A communication passage 1c is provided near the end of the syringe barrel 1 on the side surface of the syringe barrel 1 of the syringe, in which a part of the side wall protrudes radially with respect to the syringe barrel axis.
[0009]
The intermediate sliding valve 3 'is substantially cylindrical as shown in FIG. 2 (a) as viewed from the front side in the traveling direction and FIG. 2 (b) as viewed from the rear side in the traveling direction. On the side (rear side in the traveling direction), there is provided one annular lip 3a 'which makes a full circumference in the circumferential direction, this annular lip 3a' abuts on the inner wall of the syringe barrel 1, and partitions the front and rear space in the syringe barrel in a watertight manner. are doing. On the other hand, the side of the intermediate slide valve 3 'is in contact with the inner wall of the syringe barrel 1 on the side of the syringe needle (in the direction of travel), and the axis of the cylinder is injected even when the substantially cylindrical intermediate slide valve 3' slides. A holding portion 3b 'is provided so as to coincide with the axis of the cylinder 1. Unlike the annular lip 3a ', the holding portion 3b' does not go around the side surface of the intermediate sliding valve 3 ', but is provided between the annular lip 3a' on the side surface of the intermediate sliding valve 3 'and the holding portion 3b'. This space communicates with and is integrated with the space on the syringe needle side of the intermediate slide valve 3 ′, so that the first space is the same as the space between the space on the syringe needle side, the intermediate slide valve and the plunger slide valve. Of the chemical solution 5 is filled.
[0010]
Here, when an intermediate slide valve having two or more annular lips is used instead of the intermediate slide valve having such a shape, the sealed space formed by the intermediate slide valve and the inner wall of the syringe 1 is used. Although the air may be trapped and injected into the body of the subject by the injection operation, such disadvantages can be avoided with an intermediate slide valve having only one such annular lip. Further, a convex portion 3c 'is provided on the bottom surface of the intermediate sliding valve 3' in the traveling direction.
FIG. 1B is a cross-sectional view (model diagram) taken along line LL of FIG.
[0011]
Prior to use of such a kit preparation, an injection needle 7 is attached to the injection needle connection portion 1a of the injection cylinder 1 as shown in FIG. 1 (c).
[0012]
At this time, if air bubbles are generated in the first chemical solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation unit 2a with the injection needle side up. When the injection amount of the first liquid medicine 5 is particularly reduced, the plunger operation section 2a is operated at this stage to reduce the amount of the first liquid medicine 5.
[0013]
Next, the injection needle 7 is pierced into the injection required site, and thereafter, the operation of moving the plunger operation portion 2a to the side where the single injection needle is mounted is performed to inject the first drug solution 5 (see FIG. 3A).
[0014]
Thereafter, when the operation of the plunger operation section 2a is further continued, the second drug solution 6 is injected to the injection required site this time. At this time, the intermediate sliding valve 3 ′ moves toward the syringe needle and reaches the distal end of the syringe barrel. However, since the aforementioned convex portion 3 c ′ provided on the intermediate sliding valve 3 ′ abuts on the syringe barrel bottom 1 b, The intermediate slide valve 3 'does not adhere to the syringe barrel bottom 1b, and the communication passage 1c is bypassed. Therefore, even if these slide valves move to the syringe barrel bottom 1b side, the second chemical solution 6' A supply passage to the injection needle 7 is secured.
[0015]
FIG. 3B shows a state in which the operation of the plunger operation section 2a has been completed and the injection of the second drug solution 6 has been completed (injection completed state). Usually, the injection needle is removed from the injection site requiring injection in this state. However, when the injection amount of the second drug solution 6 is reduced, the injection needle is inserted while the second drug solution 6 remains in the syringe 1. May be removed from
[0016]
In such an in-line sequential dispensing syringe-type kit preparation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected into the site where the first drug solution 5 is injected. Since the second drug solution 6 is surely injected, painless or less painful injection is possible even when the second drug solution 6 is greatly different from the body fluid in pH, osmotic pressure, temperature and the like.
[0017]
However, such serial sequential dispensing syringes also have disadvantages.
That is, the space between the side surface of the intermediate sliding valve and the inner surface of the injection cylinder becomes a dead volume, and the liquid medicine existing in this space does not contribute to injection. Here, some injections are expensive such as several thousand to several tens of thousands of yen per ml, and the price may not be ignored. This is particularly remarkable when a single injection volume is as large as 100 ml as in the case of an X-ray contrast agent, or when a large-diameter syringe is used.
[0018]
However, if the holding portion 3b 'is increased in order to reduce the dead volume, the contact area with the inner wall of the injection cylinder increases, and as a result, the sliding resistance of the intermediate sliding valve increases, and the operability is significantly deteriorated. Alternatively, in order to reduce the dead volume without increasing the size of the holding portion 3b ', the thickness of the space formed between the side surface of the intermediate sliding valve and the inner surface of the injection cylinder may be reduced. Occasionally, when filling the space with air or the like, the atmosphere gas becomes bubbles and is trapped in the space and cannot be easily removed.Therefore, the gas may be injected at the time of injection.As a result, defective products are frequently generated and productivity is reduced. Not only does it decrease, but also the reliability as a pharmaceutical kit is significantly reduced.
[0019]
Here, a conventional ordinary syringe (without a communication passage) is used as the syringe itself. However, a hollow portion is provided in the intermediate sliding valve, and when the operation of injecting the pre-solution is completed, the pressure in the post-solution is used to stop the injection. There has been proposed a technique in which a part of a sliding valve is deformed to form a liquid passage between a side surface thereof and an inner wall of a syringe cylinder (JP-A-10-57486, JP-A-10-80485). Publication).
[0020]
However, the conditions for forming the liquid passage due to such deformation of the intermediate slide valve depend on the dynamic pressure applied to the intermediate slide valve and the flexibility of the material forming the intermediate slide valve. Not only when used in the ground or in extremely cold regions, but also depending on conditions such as how the operator applies force, the viscosity and temperature of the drug, and the thickness of the injection needle used, there is always a risk of malfunction, The performance was extremely low, and it was not possible to sufficiently cope with the required performance of reliably injecting a plurality of drugs in a single injection operation.
[0021]
[Problems to be solved by the invention]
The present invention solves the above-mentioned conventional problems, that is, a plurality of drugs can be reliably and sequentially injected by a single injection operation, the operability is good, and the mixing of bubbles at the time of filling a drug solution is possible. It is an object of the present invention to provide a syringe for a kit preparation, which is low in potency and has a very small dead volume which causes a drug solution that does not contribute to injection, and an intermediate slide valve that enables such a syringe for a kit preparation.
[0022]
[Means for Solving the Problems]
In order to solve the above-mentioned problems, the syringe for kit preparation of the present invention has a substantially columnar shape as described in claim 1, and is watertightly partitioned with the inner wall of the syringe when inserted into the syringe on the side surface thereof. An intermediate slide valve having a concave portion forming a space formed therein, the intermediate slide valve plunger operating side formed when the intermediate slide valve is inserted into the syringe independently of the concave portion. A rear chemical solution passage extending from the inner space of the injection cylinder to the front side of the concave part on the side in contact with the inner wall of the injection cylinder on the side of the intermediate slide valve and further from the frontmost concave part in the direction of travel of the intermediate slide valve. Having an intermediate sliding valve slidably inside the syringe barrel, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear chemical solution passage of the intermediate slide valve, and Kit having a communication passage capable of supplying a drug solution on the plunger operation side of the intermediate slide valve to the injection needle side of the intermediate slide valve in the syringe cylinder when the intermediate slide valve is connected to the intermediate slide valve. It is a syringe for use.
[0023]
With such a configuration, while the sliding resistance is reduced by the concave portion formed on the side surface of the intermediate sliding valve, the liquid-tightly defined space formed by the concave portion and the inner wall of the injection cylinder is not filled with the chemical solution, so that there is no waste. Further, since the rear chemical solution passage is provided independently of the concave portion, there is no possibility that air or the like may enter the passage.
[0024]
In addition, since the tip of the rear liquid medicine passage is provided on the surface of the side surface of the intermediate sliding valve which is in contact with the inner wall of the syringe barrel, the sliding valve itself slides in the syringe barrel and reaches near the syringe needle side end. As long as the rear chemical solution passage is not connected to a communication passage provided near the injection needle side end of the inner wall of the syringe barrel, the chemical solution behind the intermediate sliding valve in the traveling direction is supplied forward in the traveling direction of the intermediate sliding valve. Nevertheless, reliability is extremely high. Further, since the rear chemical solution passage reaches the leading side further than the foremost concave portion in the intermediate sliding valve advancing direction among the concave portions, the communication passage and the rear chemical liquid in a state where the communication passage and the concave portion are not connected. The connection with the passage can be ensured, and at this time, the gas present in the space between the concave portion and the inner wall of the syringe does not connect with the communication passage, so that the gas is prevented from being mixed into the chemical solution. I have.
[0025]
BEST MODE FOR CARRYING OUT THE INVENTION
The intermediate sliding valve in the present invention is not a sliding valve driven directly by a plunger, but a sliding valve driven indirectly by a chemical solution on the rear side in the traveling direction, has a substantially cylindrical shape, and has a side surface. An intermediate slide valve having a recess that forms a space that is watertightly defined together with the inner wall of the syringe when inserted into the syringe, wherein the intermediate slide valve is independent of the recess. From the space inside the injection cylinder on the operation side of the intermediate slide valve plunger formed when inserted into the inside of the recess, the surface of the surface of the intermediate slide valve that is in contact with the inner wall of the injection cylinder, of the concave portion, It is necessary to provide a passage for the rear chemical solution that extends further to the leading side than the concave part on the leading side.
[0026]
An example α of such an intermediate sliding valve according to the present invention is shown in FIGS.
4 (a) is a side view, FIG. 4 (b) is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4 (c) is a perspective view from the front in the sliding valve traveling direction. The intermediate slide valve α serves as a rear chemical solution passage, and a rear chemical solution inlet α1 which opens into a plunger-operating-side space in the injection cylinder formed when the intermediate slide valve α is inserted into the injection cylinder. Of the recesses on the side of the valve-operating side surface that is in contact with the inner wall of the injection cylinder, the recesses α4 (there is only one in this example, but there may be a plurality of recesses) on the forefront side of the intermediate sliding valve in the traveling direction of the intermediate sliding valve, and is further on the leading side. A rear chemical solution outlet α2 opening at a location, and a communication hole α3 formed in the slide valve α itself that communicates between the rear chemical solution inlet α1 and the rear chemical solution outlet α2. This rear chemical solution passage is provided independently of the concave portion α4 provided for the purpose of improving the slidability of the intermediate sliding valve. In this example, three rear chemical liquid passages are provided so as to be equiangular (120 °) with respect to the substantially cylindrical intermediate sliding valve α. The cross-sectional area of the rear passage for the medicinal solution is usually sufficient as long as it is equal to or greater than the cross-sectional area of the inner diameter of the injection needle to be used.
[0027]
FIGS. 4D to 4F show another example β of the intermediate sliding valve according to the present invention.
4D is a side view, FIG. 4E is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4F is a perspective view from the front in the sliding valve traveling direction.
[0028]
In this intermediate slide valve β, the rear chemical solution passage β1 is provided in a groove shape on the side surface of the intermediate slide valve β, and has a concave portion β2 provided for the purpose of improving the slidability of the intermediate slide valve. Are independently provided, and the tip of the rear chemical solution passage β1 in the direction of travel of the slide valve β is located further forward than the recess β2. Also in this example, three rear chemical liquid passages are provided so as to be at an equal angle (120 °) to the substantially cylindrical intermediate sliding valve β. The cross-sectional area of the rear passage for the medicinal solution is usually sufficient as long as it is equal to or greater than the cross-sectional area of the inner diameter of the injection needle to be used.
[0029]
4 (g) to 4 (i) show a normal plunger sliding valve (a sliding valve directly driven by the plunger) γ.
FIG. 4 (g) is a side view, FIG. 4 (h) is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4 (i) is a perspective view from the front in the sliding valve traveling direction.
[0030]
This plunger sliding valve is provided with a concave portion γ1 for reducing sliding resistance similarly to the sliding valves α and β, but is not provided with a rear chemical solution passage. Note that γ2 is a fitting hole that fits into a fitting portion at the tip of the plunger operating portion (not shown) on the injection needle side.
[0031]
The intermediate sliding valve according to the present invention as described above is slidably housed in an injection cylinder 1 as shown in a perspective view in FIG. 5 (a) and a sectional view in FIG. 5 (b). .
The syringe barrel 1 has an injection needle connection part 1a at the center of the bottom surface on one side of the injection needle, and has an opening at the other end on the plunger operation side.
[0032]
In the vicinity of the needle side end of the inner wall of the syringe barrel 1, when the intermediate sliding valve according to the present invention reaches the most needle side in the syringe barrel, it is connected to the rear chemical solution passage of the intermediate sliding valve, and A communication passage which, when connected to the rear chemical solution passage, can bypass the intermediate slide valve and supply the medicinal solution on the plunger operation side of the intermediate slide valve to the injection needle side of the intermediate slide valve in the syringe cylinder; 1c is provided. In this example, the communication passage 1c is provided so as to make one round in the circumferential direction of the inner wall of the injection cylinder 1. However, like the above-described slide valve α or β according to the present invention, the rear chemical solution passage 1d has a substantially cylindrical shape. When three are provided so as to be equiangular (120 °) with respect to the intermediate sliding valve, it is sufficient if the three are provided so as to be more than 120 ° in the circumferential direction (for example, 130 to 140 °). is there.
[0033]
Further, when the intermediate slide valve is located closest to the injection needle on the bottom surface of the injection cylinder 1, the communication passage 1 c connected to the rear chemical solution passage allows the injection needle side of the intermediate slide valve in the injection cylinder (the intermediate slide valve). A groove-shaped injection needle side liquid for supplying the chemical liquid supplied to the plunger operation side (rearward in the intermediate slide valve traveling direction) of the intermediate slide valve supplied to the front (in the forward direction) in the liquid introduction hole 1a1 for the injection needle. Four passages 1d are provided on the bottom surface of the injection needle 1 on the side of the injection needle, each at an equal angle (90 °) to the substantially cylindrical injection cylinder 1. However, it is usually sufficient if one injection needle side needle liquid passage 1d is provided, and the cross-sectional area of the passage is equal to or more than the cross-sectional area of the inner diameter of the used injection needle (preferably 1.5 times or more). (Approximately 2 times) is usually sufficient, and the smaller the amount, the smaller the amount of the remaining chemical solution.
[0034]
FIGS. 6A to 6C show a second example of the plunger sliding valve used together.
6 (a) is a side view, FIG. 6 (b) is a perspective view from the rear in the sliding valve traveling direction, and FIG. 6 (c) is a perspective view from the front in the sliding valve traveling direction.
[0035]
By adapting the front surface of the plunger sliding valve in the traveling direction to the shape of the rear surface in the traveling direction of the intermediate sliding valve to be used, the amount of chemical solution remaining between these sliding valves can be reduced. The center of the rear surface of the intermediate sliding valve in the advancing direction of the intermediate sliding valve shown in FIG. 6B is a fitting hole (modelly shown) that fits into a fitting part at the tip of the plunger operating part (not shown) on the injection needle side. It is.
[0036]
FIG. 7 (a) shows an example of a syringe-type kit preparation using the in-line sequential dispensing syringe according to the present invention prepared using the above-described intermediate slide valve α, syringe barrel 1 and plunger slide valve 2. This is shown in a model sectional view.
[0037]
The kit formulation shown in FIG. 7 has one intermediate slide valve α and one plunger in a syringe barrel 1 having an injection needle connection part 1a at one end and an opening at the other end of the plunger operation side. The sliding valve 2 is slidably housed, and the inside of the syringe barrel 1 is watertightly partitioned by the sliding valves α and 2 before and after it. Further, the injection needle mounting portion 1a of the injection cylinder 1 is hermetically sealed by a cap 4 made of an elastomeric material, and a first liquid medicine 5 is filled in the injection needle side space of the intermediate slide valve α with the intermediate slide valve α. The space between the plunger slide valve 2 and the plunger slide valve 2 is filled with a second chemical solution 6, respectively.
[0038]
Prior to use of such a kit preparation, the injection needle 7 is attached to the injection needle connection portion 1a of the injection cylinder 1 as shown in FIG. 7 (b) (instead of the injection needle 7, a tube, cock, etc.). Accessories may be connected). A plunger operation section 2a is attached to the plunger sliding valve 2.
[0039]
At this time, if air bubbles are generated in the first chemical solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation unit 2a with the injection needle side up. When the injection amount of the first liquid medicine 5 is particularly reduced, the plunger operation section 2a is operated at this stage to reduce the amount of the first liquid medicine 5.
[0040]
Next, the injection needle 7 is stabbed into the injection required site, and then the operation of moving the plunger operation section 2a to the injection needle side of the injection cylinder 1 is performed to inject the first drug solution 5 (see FIG. 7C).
[0041]
Thereafter, when the operation of the plunger operation section 2a is further continued, the second drug solution 6 is injected to the injection required site this time. At this time, the intermediate sliding valve α moves toward the syringe needle and reaches the tip of the syringe cylinder (most injection needle side) (see FIG. 8A).
[0042]
At this time, the rear chemical solution outlet α2 of the rear chemical solution passage of the intermediate slide valve α is connected to a communication passage 1c provided near the injection needle side end of the inner wall of the injection cylinder 1, and the communication passage 1c is further connected to the injection cylinder 1 Since it is connected to the injection needle side liquid passage 1d provided on the injection needle side bottom surface, the rear chemical solution 6 in the plunger operation side space of the intermediate slide valve α passes from the rear chemical solution inlet α1 of the rear chemical solution passage to the communication hole α3 and the communication hole α3. The liquid is introduced into the injection needle through the rear liquid medicine outlet α2, the communication passage 1c, and the injection needle side liquid passage 1d. When the intermediate slide valve α does not reach the tip of the syringe 1, the rear chemical solution outlet α 2 is sealed by the inner surface of the syringe 1, and therefore, the middle of the rear chemical 6 in the plunger operation side space of the intermediate slide valve α. The sliding valve does not move toward the injection needle in the syringe cylinder.
[0043]
FIG. 9 shows a state in which the operation of the plunger operation section 2a has been completed and the injection of the second drug solution 6 has been completed (injection completed state). Usually, the injection needle is removed from the injection site requiring injection in this state. However, when the injection amount of the second drug solution 6 is reduced, the injection needle is inserted while the second drug solution 6 remains in the syringe 1. May be removed from
[0044]
In such an in-line sequential dispensing syringe-type kit preparation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected into the site where the first drug solution 5 is injected. Since the second drug solution 6 is surely injected, painless or less painful injection is possible even when the second drug solution 6 is greatly different from the body fluid in pH, osmotic pressure, temperature and the like.
[0045]
Although the example using the intermediate sliding valve α according to the present invention has been described above, the operation is the same even when the intermediate sliding valve β according to the present invention is used. ), The rear chemical solution 6 in the plunger operation-side space of the intermediate sliding valve α is supplied from the rear chemical solution inlet α1 of the rear chemical solution passage to the communication hole α3 and the rear chemical solution outlet α2, the communication passage 1c, the injection needle side solution. As shown in FIG. 8 (b), the liquid is introduced into the injection needle via the passage 1d. As shown in FIG. It is introduced into the injection needle via the passage 1d.
[0046]
Also, an example of the introduction of the liquid behind the intermediate sliding valve by a communication hole formed in the intermediate sliding valve itself as a rear chemical liquid passage by the intermediate sliding valve α according to the present invention, the intermediate sliding valve β according to the present invention Examples of the introduction of the rear liquid of the intermediate slide valve by the grooves provided on the side of the intermediate slide valve as the passage for the rear chemical solution have been described. For example, as shown in FIGS. 10 (a) and 10 (b), The rear liquid of the intermediate sliding valve may be introduced by using both the groove and the communication hole as the rear chemical liquid passage (the order of the groove and the communication hole may be reversed). include.
[0047]
In the present invention, the movement of the intermediate slide valve in the injection cylinder is caused by the pressure applied via the rear chemical, but the rear chemical liquid passage is connected to the communication passage provided near the injection needle side end of the inner wall of the syringe cylinder. At that moment, the pressure suddenly drops, so that the movement of the intermediate slide valve must be performed before the cross-sectional area of the connecting point between the rear drug solution passage and the communication passage does not become larger than the inner cross-sectional area of the used injection needle. In some cases, the plunger will stop and require a great deal of force to operate the plunger thereafter.
[0048]
In order to solve such an inconvenience, it is desirable to provide an enlarged portion at the foremost side of the rear chemical solution passage in the intermediate sliding valve advancing direction, for expanding the rear chemical solution passage in the circumferential direction of the slide valve side surface.
[0049]
FIGS. 11A to 11F show examples of such an intermediate sliding valve.
FIGS. 11 (a) to 11 (c) show an example of the intermediate sliding valve α according to the present invention, in which an enlarged portion α5 ′ for enlarging the rear chemical liquid passage in the circumferential direction of the sliding valve side surface is provided. 11 (d) to 11 (f) show an example β of the intermediate sliding valve according to the present invention, in which an enlarged portion β3 ′ for expanding the rear chemical solution passage in the circumferential direction of the sliding valve side surface is provided. The symbols in these figures correspond to the symbols in FIGS. 4A to 4F without “′”.
[0050]
In addition, the injection cylinder 1 used above is provided with a groove-shaped injection needle side liquid passage 1d on the injection needle side bottom surface, but the groove-shaped injection needle side liquid passage is formed on the injection needle side bottom surface of the injection cylinder. Instead, for example, a groove-shaped injection needle side liquid passage may be provided on the front side in the traveling direction of the intermediate sliding valve, and examples of such an intermediate sliding valve are shown in FIGS. 12 (a) to 12 (f). .
[0051]
FIGS. 12 (a) to 12 (c) show an example of the intermediate sliding valve α according to the present invention, in which a groove-shaped injection needle side liquid passage α6 ″ is provided on the front side in the traveling direction of the intermediate sliding valve. 12 (d) to 12 (f) show an example of the intermediate sliding valve β according to the present invention, in which a groove-shaped injection needle side liquid passage β4 ″ is provided on the front side in the traveling direction of the intermediate sliding valve. Is shown. The symbols in these figures correspond to the symbols in FIGS. 4A to 4F without “” ”.
[0052]
Due to the groove-shaped injection needle side liquid passage provided on the front side in the traveling direction of these intermediate slide valves, the intermediate slide valve reaches the injection needle side most in the syringe barrel, and the side of the injection needle is the syringe needle. The liquid flow between the communication passage provided near the injection needle side end of the inner wall of the syringe and the liquid introduction hole to the injection needle provided on the injection needle side bottom even when the liquid is in close contact with the side bottom. Is secured. The cross-sectional area of the liquid passage on the side surface of the injection needle is desirably equal to or larger than the inner diameter cross-sectional area of the injection needle to be used. Sufficiently, and in the above example, there are three liquid passages on the side of the injection needle, but one is usually sufficient.
[0053]
Also, instead of the groove-shaped injection needle side liquid passage, even when the intermediate sliding valve is moved to the injection needle side, the intermediate slide valve does not adhere to the injection needle side bottom surface of the injection cylinder, and from the communication passage to the injection needle. 13 (a) to 13 (c), a convex portion may be provided on the front side surface in the traveling direction of the intermediate sliding valve so as to secure the liquid flow. The intermediate sliding valve β ″ ″ is provided with an anti-adhesion projection β5 ″ ″ that prevents the intermediate sliding valve from coming into close contact with the bottom surface of the syringe needle even when the intermediate sliding valve reaches the injection needle side in the syringe barrel. It is provided on the front side in the traveling direction of the intermediate sliding valve of the sliding valve β. However, securing the liquid passage by the contact preventing protrusions tends to increase the dead volume more than in the other examples described above, and in that case, the amount of wasted chemical liquid increases.
[0054]
Here, as an application example of the above-mentioned syringe for a kit preparation, a kit preparation for an X-ray contrast agent can be mentioned.
That is, two or more spaces partitioned in a watertight manner by an intermediate slide valve or a plunger slide valve inserted into the syringe are each filled with a chemical in advance, and the chemicals are sequentially mixed without being mixed by the operation of the plunger. In a kit preparation using a serial sequential dispensing syringe to be discharged, one drug solution is a drug solution having an X-ray contrast agent, and the drug solution having no X-ray contrast agent after discharging the drug solution having the X-ray contrast agent Is an X-ray contrast agent kit preparation that is excreted.
[0055]
At this time, various effects can be obtained by the fact that the drug solution having no X-ray contrast agent is physiological saline, a blood substitute other than physiological saline, a vitamin, or a mixture of two or more selected from distilled water. can get.
[0056]
For example, in the kit preparation shown in FIG. 7, 70 mL of an X-ray contrast agent is filled as the first drug solution 5, and physiological saline, a blood substitute other than physiological saline, a vitamin agent, and distilled water are used as the second drug solution. Is filled with 30 mL of one or a mixture of two or more selected from the group consisting of: Here, as a blood substitute, for example, physiological saline, sodium chloride injection, dextran injection, ammonium chloride injection, potassium chloride injection, hydroxyethyl starch injection, dipotassium phosphate injection, starting solution (chloride Sodium / glucose agent), glucose / dextran agent, maintenance solution (sodium lactate / inorganic salt / saccharide agent), postoperative recovery solution, dehydration replenisher solution, Ringer's acetate solution, Ringer's solution, mannitol combination, and the like. That is, the second drug does not need to have a great effect on medicine and physiology, and its main purposes are the following three.
[0057]
1. X-ray contrast agents are often introduced into the body of a subject via an extension tube or a catheter. The inner volume of the tube and catheter becomes a dead volume, and the drug solution remains. Therefore, in the case of a kit preparation, it is necessary to fill an amount obtained by adding a dead volume to a necessary amount to be introduced into the body. However, the X-ray contrast agent is very expensive at about 20,000 yen per 100 ml, and it is not economical to fill extra. Here, only the necessary amount to be introduced into the body of the subject as the X-ray contrast agent of the first drug solution is filled, and the drug is introduced into the body (or blood vessel) as the second drug solution. It is possible to select an object and "push" all the necessary amount including the first liquid remaining in the tube into the subject.
[0058]
The plunger operation for introducing the X-ray contrast agent is performed in an automatic and remote control by an automatic injector because the operation is performed in the X-ray imaging room. The use of a conventional injector allows operation by a conventional automatic injector, and eliminates the need to purchase a new automatic injector.
[0059]
Furthermore, since the preparation is a kit preparation as described above, operations such as opening the drug container and suctioning into a syringe are unnecessary, and there is no concern about such operations, contamination with foreign substances, contamination of bacteria and viruses, and stopcocks. Since there is no need to use a combination of bacteria, contamination of bacteria and viruses by a stopcock and operational errors are prevented in advance.
[0060]
2. The contrast agent remaining in the vein or in the venous valve after the introduction of the X-ray contrast agent may be coagulated, which may cause thrombophlebitis. The introduction prevents these contrast agents from remaining.
[0061]
3. It is possible to quickly push (flash) the contrast agent into the body, improve the contrast effect of the main blood vessels, and reduce the appearance of artifacts (virtual images) around the veins. The amount of the contrast agent can be reduced, which is advantageous in terms of cost and can reduce the burden on the subject's body.
[0062]
【The invention's effect】
INDUSTRIAL APPLICABILITY The syringe for kit preparation of the present invention can reliably and sequentially inject a plurality of drugs in a single injection operation, has good operability, has a low possibility of mixing of bubbles at the time of filling a drug solution, and performs injection. It is an excellent syringe for kit preparation, which has a very small dead volume that causes a drug solution that does not contribute to the drug solution.
[Brief description of the drawings]
FIG. 1 (a) is a model diagram showing a conventional example of a syringe-type kit preparation using a serial sequential dispensing syringe capable of injecting two kinds of drugs in one operation.
(B) It is sectional drawing (model figure) in LL of FIG.1 (a).
(C) It is a figure showing the state where the injection needle was attached.
FIG. 2 is a view showing an intermediate sliding valve 3 'according to the prior art.
(A) A perspective view seen from the front side in the traveling direction.
(B) A perspective view seen from the rear side in the traveling direction.
FIG. 3A is a diagram showing a state in which the injection of a first chemical solution 5 has been completed.
FIG. 6B is a diagram illustrating a state in which the operation of the plunger operation unit 2a has been completed and the injection of the second chemical solution 6 has been completed (injection completed state).
FIG. 4 is a view showing intermediate sliding valves α and β according to the present invention and a plunger sliding valve γ according to the prior art.
(A) Side view of the intermediate sliding valve α
(B) A perspective view of the intermediate sliding valve α as viewed from the rear side in the traveling direction.
(C) A perspective view of the intermediate sliding valve α as viewed from the front in the traveling direction.
(D) Side view of intermediate sliding valve β
(E) A perspective view of the intermediate sliding valve β as viewed from the rear in the traveling direction.
(F) A perspective view of the intermediate sliding valve β as viewed from the front in the traveling direction.
(G) Side view of plunger sliding valve γ
(H) A perspective view of the plunger sliding valve γ viewed from the rear side in the traveling direction.
(I) A perspective view of the plunger sliding valve γ as viewed from the front in the traveling direction.
FIG. 5 is a diagram showing an example of a syringe used in the syringe for kit preparation of the present invention.
(A) Sectional view
(B) Partial perspective view seen from the injection needle mounting side
FIG. 6 is a view showing an example of a plunger sliding valve used in the syringe for kit preparation of the present invention.
(A) Side view
(B) A perspective view seen from the rear side in the traveling direction.
(C) A perspective view seen from the front side in the traveling direction.
FIG. 7 (a) is a model diagram showing a syringe-type kit preparation using a serial sequential dispensing syringe according to the present invention, which can inject two kinds of drugs in one operation.
(B) It is a figure showing the state where injection needle 7 and plunger operation part 2a were attached.
(C) It is a figure showing the state where injection of the 1st medical fluid 5 was completed.
FIG. 8A is a partially enlarged cross-sectional view showing the flow of a second chemical solution when the intermediate sliding valve α according to the present invention is used.
(B) It is a partial enlarged sectional view showing a state of the flow of the second chemical solution when the intermediate sliding valve β according to the present invention is used.
9A is a view showing a state in which the operation of the plunger operation section 2a has been completed and the injection of the second chemical solution 6 has been completed (injection completed state). FIG.
FIG. 10 is a view showing another sliding valve according to the present invention.
(A) Side view
(B) A perspective view seen from the rear side in the traveling direction.
FIG. 11 is an intermediate sliding valve α ′ according to the present invention having an enlarged portion at the foremost side of the rear chemical liquid passage in the intermediate sliding valve advancing direction, which enlarges the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve. It is a figure which shows (beta) '.
(A) Side view of intermediate sliding valve α '
(B) A perspective view of the intermediate sliding valve α ′ as viewed from the rear in the traveling direction.
(C) A perspective view of the intermediate sliding valve α 'as viewed from the front in the traveling direction.
(D) Side view of intermediate sliding valve β '
(E) A perspective view of the intermediate sliding valve β ′ as viewed from the rear in the traveling direction.
(F) A perspective view of the intermediate sliding valve β ′ as viewed from the front in the traveling direction.
FIG. 12 is a view showing intermediate sliding valves α ″ and β ″ in which a groove-shaped injection needle side liquid passage is provided on a front side surface in the traveling direction of the intermediate sliding valve.
(A) Side view of the intermediate sliding valve α ″
(B) A perspective view of the intermediate sliding valve α ″ viewed from the rear side in the traveling direction.
(C) A perspective view of the intermediate sliding valve α ″ as viewed from the front in the traveling direction.
(D) Side view of the intermediate sliding valve β ″
(E) A perspective view of the intermediate sliding valve β ″ viewed from the rear side in the traveling direction.
(F) A perspective view of the intermediate sliding valve β ″ viewed from the front in the traveling direction.
FIG. 13 is a view showing an intermediate sliding valve β ″ ′ having an adhesion preventing convex portion that prevents adhesion to the bottom surface of the injection needle on the injection needle side even when reaching the injection needle side in the injection cylinder.
(A) Side view
(B) A perspective view seen from the rear side in the traveling direction.
(C) A perspective view seen from the front side in the traveling direction.
[Explanation of symbols]
1 syringe
1a Injection needle connection
1c Communication passage
2 Plunger sliding valve
2a Plunger operation unit
α, β Intermediate sliding valve according to the present invention
4 caps
5 First chemical liquid
6 Second chemical solution
7 injection needle

Claims

略円柱状であって、その側面に注射筒内に挿入された際に注射筒内壁とともに水密に区画された空間を形成する凹部を有する中間摺動弁であって、該凹部とは独立して、該中間摺動弁が注射筒内に挿入された際に形成される該中間摺動弁プランジャ操作側の注射筒内空間から、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側に至る後方薬液用通路を備えた中間摺動弁を注射筒内部に摺動可能に有し、かつ、
該注射筒の内壁の注射針側端付近に、該中間摺動弁が注射筒内の最も注射針側に達したときに上記中間摺動弁の後方薬液用通路に接続し、かつ、後方薬液用通路に接続したときに、中間摺動弁をバイパスして、中間摺動弁のプランジャ操作側の薬液を該中間摺動弁の注射筒内注射針側に供給可能な連通通路を有することを特徴とするキット製剤用注射器。An intermediate slide valve having a substantially cylindrical shape and having a concave portion that forms a space that is watertightly defined together with the inner wall of the syringe when inserted into the syringe on the side surface thereof, independently of the concave. The concave portion on the surface of the intermediate sliding valve, which is formed when the intermediate sliding valve is inserted into the syringe cylinder, on the side of the intermediate sliding valve that is in contact with the inner surface of the syringe cylinder on the side of the intermediate sliding valve; Of the intermediate sliding valve, the intermediate sliding valve having a rear chemical solution passage that extends further to the leading side than the foremost concave portion in the advancing direction of the intermediate sliding valve has a slidable inside the injection cylinder, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear chemical solution passage of the intermediate slide valve, and A communication passage capable of supplying a chemical solution on the plunger operation side of the intermediate slide valve to the injection needle side of the intermediate slide valve in the injection cylinder when the intermediate slide valve is connected to the intermediate slide valve. A syringe for kit preparation, which is characterized by the following.

上記中間摺動弁が注射筒内の最も注射針側に達したときにも注射筒注射針側底面への密着を防止する密着防止凸部を有することを特徴とする請求項１に記載のキット製剤用注射器。2. The kit according to claim 1, wherein the intermediate slide valve has an adhesion preventing convex portion for preventing the intermediate slide valve from coming into close contact with the bottom surface of the injection needle side even when the intermediate slide valve reaches the end of the injection needle closest to the injection needle side. Formulation syringe.

上記中間摺動弁が注射筒内の最も注射針側に達し、その注射針側面が注射筒注射針側底面に密着した際にも、注射筒の内壁の注射針側端付近に設けられた上記連通通路と注射筒注射針側底面に設けられた注射針への液導入孔との間の液流を確保する注射針側面液通路が中間摺動弁に設けられていることを特徴とする請求項１に記載のキット製剤用注射器。Even when the intermediate slide valve reaches the most needle side in the syringe barrel and the side surface of the needle closely adheres to the bottom surface of the syringe needle side, the inner slide valve is provided near the needle side end of the inner wall of the syringe barrel. The intermediate slide valve is provided with a liquid passage on the side of the injection needle for securing a liquid flow between the communication passage and a liquid introduction hole for the injection needle provided on the bottom surface of the syringe needle on the injection needle side. Item 4. The syringe for kit preparation according to Item 1.

略円柱状であって、その側面に注射筒内に挿入された際に注射筒内壁とともに水密に区画された空間を形成する凹部を有する注射器型キット製剤用中間摺動弁において、該凹部とは独立して、該中間摺動弁が注射筒内に挿入された際に形成される該中間摺動弁プランジャ操作側の注射筒内空間から、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側に至る後方薬液用通路を備えたことを特徴とする注射器型キット製剤用中間摺動弁。An intermediate slide valve for a syringe-type kit formulation having a substantially columnar shape and having a concave portion that forms a watertightly partitioned space with the inner wall of the syringe when inserted into the syringe on the side surface, wherein the concave is Independently, from the space in the injection cylinder on the plunger operating side formed when the intermediate slide valve is inserted into the injection cylinder, the surface in contact with the inner wall of the injection cylinder on the side of the intermediate slide valve is An intermediate slide valve for a syringe-type kit preparation, comprising: a rear passage for a chemical solution, which further extends to the forefront side of the recess in the forward direction of the intermediate slide valve among the recesses.

上記後方薬液用通路の中間摺動弁進行方向の最も先頭側に該後方薬液用通路を摺動弁側面周方向に拡大する拡大部を有することを特徴とする請求項４に記載の注射器型キット製剤用中間摺動弁。The syringe-type kit according to claim 4, further comprising an enlarged portion for expanding the rear chemical solution passage in a circumferential direction of a side surface of the slide valve at the foremost side of the rear chemical solution passage in the intermediate sliding valve advancing direction. Intermediate sliding valve for pharmaceuticals.

上記後方薬液用通路が、注射器型キット製剤用中間摺動弁が注射筒内に挿入された際に形成されるプランジャ操作側の注射筒内空間に開口する後方薬液入口、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側箇所に開口する後方薬液出口、及び、これら後方薬液入口と後方薬液出口とを連通する、注射器型キット製剤用中間摺動弁に穿たれた連通孔により構成されることを特徴とする請求項４または請求項５のいずれかに記載の注射器型キット製剤用中間摺動弁。The rear drug solution passage, the rear drug solution inlet opening to the plunger operation side in the syringe barrel space formed when the syringe type kit formulation intermediate slide valve is inserted into the syringe barrel, the side of the middle slide valve Of the recesses on the surface in contact with the inner wall of the syringe barrel, a rear chemical solution outlet that opens further to the forefront than the foremost recess in the direction of travel of the intermediate sliding valve among the recesses, and communicates between the rear chemical solution inlet and the rear chemical solution outlet. The intermediate slide valve for a syringe-type kit formulation according to claim 4, wherein the intermediate slide valve for a syringe-type kit formulation is constituted by a communication hole formed in the intermediate slide valve for a syringe-type kit formulation.

上記後方薬液用通路が、上記注射器型キット製剤用中間摺動弁の側面に溝状に設けられてなることを特徴とする請求項４または請求項５のいずれかに記載の注射器型キット製剤用中間摺動弁。6. The syringe-type kit preparation according to claim 4, wherein the rear drug solution passage is provided in a groove shape on a side surface of the intermediate slide valve for the syringe-type kit preparation. Intermediate sliding valve.

略円柱状であって、その側面に注射筒内に挿入された際に注射筒内壁とともに水密に区画された空間を形成する凹部を有する中間摺動弁であって、該凹部とは独立して、該中間摺動弁が注射筒内に挿入された際に形成される該中間摺動弁プランジャ操作側の注射筒内空間から、中間摺動弁側面の注射筒内壁に接する面の、上記凹部のうち中間摺動弁進行方向の最も先頭側の凹部よりもさらに先頭側に至る後方薬液用通路を備えた中間摺動弁を注射筒内部に摺動可能に有し、かつ、
該注射筒の内壁の注射針側端付近に、該中間摺動弁が注射筒内の最も注射針側に達したときに上記中間摺動弁の後方薬液用通路に接続し、かつ、後方薬液用通路に接続したときに、中間摺動弁をバイパスして、該中間摺動弁のプランジャ操作側の薬液を該中間摺動弁の注射筒内注射針側に供給可能な連通通路を有するキット製剤用注射器の、少なくとも注射筒の中間摺動弁のプランジャ操作側空間に薬液が充填されていることを特徴とする注射器型キット製剤。An intermediate slide valve having a substantially cylindrical shape and having a concave portion that forms a space that is watertightly defined together with the inner wall of the syringe when inserted into the syringe on the side surface thereof, independently of the concave. The concave portion on the surface of the intermediate sliding valve, which is formed when the intermediate sliding valve is inserted into the syringe cylinder, on the side of the intermediate sliding valve that is in contact with the inner surface of the syringe cylinder on the side of the intermediate sliding valve; Of the intermediate sliding valve, the intermediate sliding valve having a rear chemical solution passage that extends further to the leading side than the foremost concave portion in the advancing direction of the intermediate sliding valve has a slidable inside the injection cylinder, and
Near the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most needle side in the syringe barrel, it is connected to the rear chemical solution passage of the intermediate slide valve, and Kit having a communication passage capable of supplying a chemical solution on the plunger operation side of the intermediate slide valve to the injection needle side of the intermediate slide valve in the syringe barrel, when the intermediate slide valve is connected to the intermediate slide valve. A syringe-type kit preparation, characterized in that at least a medicinal solution is filled in a space for a plunger operation side of an intermediate slide valve of a syringe barrel of the preparation syringe.

注射筒内に挿入された中間摺動弁あるいはプランジャ摺動弁によって水密に区画された２つ以上の空間にあらかじめそれぞれ薬液が充填され、該薬液がプランジャの操作によって混合されることなく順次排出される直列順次分注型注射器を用いるキット製剤において、１つの薬液がＸ線造影剤を有する薬液であり、かつ、該Ｘ線造影剤を有する薬液の排出後にＸ線造影剤を有しない薬液が排出されることを特徴とするＸ線造影剤キット製剤。Two or more spaces watertightly partitioned by an intermediate slide valve or a plunger slide valve inserted into the syringe are each filled with a chemical in advance, and the chemicals are sequentially discharged without being mixed by the operation of the plunger. In a kit preparation using an in-line sequential dispensing syringe, one drug solution is a drug solution having an X-ray contrast agent, and a drug solution having no X-ray contrast agent is discharged after discharging the drug solution having the X-ray contrast agent. An X-ray contrast agent kit preparation characterized in that:

上記Ｘ線造影剤を有しない薬液が生理食塩水、生理食塩水以外の血液代用剤、ビタミン剤、蒸留水から選ばれる１種、または２種以上の混合物であることを特徴とする請求項９に記載のＸ線造影剤キット製剤。10. The liquid medicine having no X-ray contrast medium is a physiological saline, a blood substitute other than the physiological saline, a vitamin, or a mixture of two or more selected from distilled water. 3. The X-ray contrast agent kit preparation according to item 1.