JP3976658B2 - Syringe for kit preparation, intermediate sliding valve for syringe-type kit preparation, syringe-type kit preparation, and method for producing syringe for kit preparation - Google Patents

Syringe for kit preparation, intermediate sliding valve for syringe-type kit preparation, syringe-type kit preparation, and method for producing syringe for kit preparation Download PDF

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JP3976658B2
JP3976658B2 JP2002294581A JP2002294581A JP3976658B2 JP 3976658 B2 JP3976658 B2 JP 3976658B2 JP 2002294581 A JP2002294581 A JP 2002294581A JP 2002294581 A JP2002294581 A JP 2002294581A JP 3976658 B2 JP3976658 B2 JP 3976658B2
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syringe
syringe barrel
slide valve
valve
sliding valve
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JP2004129695A (en
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哲郎 東川
英郎 秋山
一夫 柳沢
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Hisamitsu Pharmaceutical Co Inc
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Hisamitsu Pharmaceutical Co Inc
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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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/284—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/3129—Syringe barrels
    • A61M2005/3132—Syringe barrels having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase

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、キット製剤用注射筒の製造方法に関する。
【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（特許文献１）、特開平１０−８０４８５号公報（特許文献２））。
【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】
【特許文献１】
特開平１０−５７４８６号公報（第１−３頁）
【特許文献２】
特開平１０−８０４８５号公報（第１−３頁）
【００２２】
【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。
【００２３】
【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と注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部と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、および、該後方薬液用通路の中間摺動弁進行方向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、該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。
【００２４】
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。
【００２５】
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。
【００２６】
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。
【００２７】
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。
ここで、上記目的の場合には注射筒内壁周方向１２０°に達するないし一周するような幅の広い連通通路が設けられている注射筒を用いる場合には、中間摺動弁の後方薬液用通路は中間摺動弁進行方向に幅が広い必要はないが、注射筒の連通通路の幅が狭い場合には、上記拡大部をさらに大きなものとすることにより対応することができる。すなわち、この拡大部を中間摺動弁周方向に対して充分幅広に、好ましくは、中間摺動弁周方向６０°以上に、さらに好ましくは９０°以上（１２０°以上、あるいは１８０°以上）に、亘るように設けることにより、対応可能なキット用注射器の種類を増やすことができる。
【００２８】
【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と注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部と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。
【００２９】
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。また図中符号α８は注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部を示す。
【００３０】
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。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、その条件を満足する場合には後方薬液用通路は１つであっても充分であり、後方薬液用通路の容積が小さいほど残留する薬液の量は少なくてすむ。
【００３１】
この中間摺動弁αの後方薬液用通路の中間摺動弁進行方向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α７は略円筒状の中間摺動弁αの周方向１周するように設けられている。このため、後述するように中間摺動弁αは様々なキット製剤用注射筒に対応することができる。
【００３２】
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。
【００３３】
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よりもさらに進行方向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。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、この条件が満足されれば後方薬液用通路は一つでも充分であり、後方薬液用通路の容積が小さいほど残留する薬液の量は少なくてすむ。また図中符号８は注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部を示す。
【００３４】
この中間摺動弁βの後方薬液用通路の中間摺動弁進行方向先頭側に該後方薬液用通路β１を摺動弁側面周方向に拡大する拡大部β６は略円筒状の中間摺動弁βの周方向１周するように設けられている。このため、後述するように中間摺動弁βは様々なキット製剤用注射筒に対応することができる。
【００３５】
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。
【００３６】
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。
【００３７】
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。
【００３８】
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、該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。
【００３９】
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。
なお、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。
【００４０】
なお、図５（ａ）および図５（ｂ）に示した注射筒１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、本発明の中間摺動弁は図６（ａ）および図６（ｂ）に示すような注射筒にも対応可能である。
図６（ａ）にその断面（連通通路１ｃ’を含む面での断面図）を、図６（ｂ）にその先端側を斜視図で示す注射筒１’では連通通路１ｃ’は幅が狭く、円筒状の注射筒の内壁の注射針側端に、注射筒１’注射針側底面に設けられた注射針への液導入孔１ａ１’に接続された溝状の注射針側面液通路１ｄ’と一体となるように、注射筒の円筒の中心線に対して互いに１８０°となる位置に２つ設けられている。
なお、図６（ｃ）は注射筒１’の断面図であるが、連通通路１ｃ’を含まない面での断面図である。
【００４１】
このような注射筒１’に対して中間摺動弁αの後方薬液用通路の中間摺動弁進行方向先頭側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α７は略円筒状の中間摺動弁αの周方向約１８０°以上に亘るように設けられていれば、その中間摺動弁が注射筒１’内の最も注射針側に達したときには、中間摺動弁のプランジャ操作側の薬液が確実に該中間摺動弁の注射筒内注射針側に供給可能となる。
【００４２】
なお、連通通路は幅が狭くても、例えば円筒状の注射筒の内壁の注射針側端に注射筒の円筒の中心線に対して互いに１２０°となる位置に３つ、あるいは、互いに９０°となる位置に４つ、また、互いに６０°となる位置に６つ設けられることにより、中間摺動弁に設けられる後方薬液用通路を摺動弁側面周方向に拡大する拡大部は略円筒状の中間摺動弁αの周方向にそれぞれ約１２０°以上、あるいは９０°以上、または６０°以上占めるように設けられれば充分である。
【００４３】
このような拡大部により、一回の射出成形では成形上工夫が必要な注射筒の内壁への連通通路の形成を、その形状の自由度の向上によりより容易なものとすることが可能となり、注射筒用成形金型のコストを低廉なものとすることを可能とし、延いては、注射筒のコストを下げることが可能となる。
【００４４】
ここで、上記注射筒１’の成形方法について円柱状の中型を示す図７および図８を用いて、簡単に述べる。
注射筒１’は注射筒内壁の注射針側端付近に、摺動弁をバイパスして、該摺動弁のプランジャ操作側の薬液を該摺動弁の注射筒内注射針側に供給可能な連通通路が凹部によって形成されたキット製剤用注射筒であり、これは、外型と円柱状の中型との間に形成されたキャビティ内に樹脂を導入して成形するキット製剤用注射筒の製造方法によって製造される。
【００４５】
ここで図７（ａ）および図８（ａ）にはそれぞれ異なったタイプの円柱状の中型１０および１０’をモデル的に示す。
これら円柱状の中型が、複数の割型部（図７（ａ）に示す中型の場合には２つの割型部１０ａ、図８（ａ）に示す中型の場合には４つの割型部１０ａ’をそれぞれ有する）と、これら割型部１０ａ同士あるいは１０ａ’同士の間に位置し、該割型部１０ａあるいは１０ａ’とともに円柱状の中型１０あるいは１０’の、成形される注射筒の注射針側底面を形成する面と、注射筒内側面を形成する面とを構成し、かつ、プランジャ注射筒プランジャ操作側に摺動可能なスライダ部１０ｂ（図７（ｂ）参照）あるいは１０ｂ’（図８（ｂ）参照）とにより構成されている。
【００４６】
スライダ部１０ｂ（図７（ｂ）参照）および１０ｂ’（図８（ｂ）参照）は注射筒プランジャ操作側（図中右側）になるほど厚くなる、いわゆるテーパー状となっており、各割型部はそれに応じて薄くなっている、逆テーパー状となっている。
【００４７】
２つの割型部１０ａには両方に、および、４つの割型部１０ａ’の２つには上記連通通路を形成するための連通通路形成用凸部１０ａ１および１０ａ１’がそれぞれ設けられており、キャビティ内に導入された樹脂の硬化あるいは凝固後に図７（ｃ）あるいは図８（ｃ）に示すようにテーパー形状を有するスライダ部１０ｂ、スライダ部１０ｂ’が注射筒プランジャ操作側（図７（ｃ）、図８（ｃ）における実線矢印方向）にスライドして形成された空間に、連通通路形成用凸部が設けられた割型部を含むすべての割型部１０ａあるいは１０ａ’が退避する（その方向を図７（ｃ）、図８（ｃ）中に波線矢印で示した）ことにより、連通通路形成用凸部１０ａあるいは１０ａ’と形成された注射筒の連通通路との勘合が解除された後に製造された注射筒を取り出すことにより、図６に示すようなキット製剤用注射筒１’を得ることができる。
【００４８】
なお上記ではスライダ部はテーパー状、割型部は逆テーパー状となっているためにスライダ部が割型部同士間の空間でスライドするだけで連通通路形成用凸部が形成された注射筒の連通通路との勘合が解除されるが、スライダ部を割型部同士間の空間から完全に除去するようにスライドさせててもよく、この場合にはスライダ部のテーパー状形状および割型部の逆テーパー状形状は必ずしも必要ではない。
【００４９】
図９（ａ）〜図９（ｃ）には併用するプランジャ摺動弁の例２を示した。
図９（ａ）は側面図、図９（ｂ）は摺動弁進行方向後方からの斜視図、図９（ｃ）は摺動弁進行方向前方からの斜視図である。
【００５０】
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。
【００５１】
上記のような中間摺動弁β、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１０（ａ）にモデル断面図で示す。
【００５２】
図１０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’（図６（ａ）〜（ｃ）に示したもの）内に、１個の中間摺動弁β（図４（ｄ）〜（ｆ）に示したもの）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’内部はこれら中間摺動弁β及びプランジャ摺動弁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βの注射筒針側空間には第１の薬液５が、中間摺動弁β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。
【００５３】
このようなキット製剤は使用に先立ち、図１０（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。
【００５４】
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。
【００５５】
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１０（ｃ）参照）。
【００５６】
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β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１１（ａ）参照）。
【００５７】
このとき、中間摺動弁βの後方薬液用通路β１は拡大部β６を介して、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β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β１、拡大部β４、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。
【００５８】
なお、中間摺動弁βが注射筒１先端部に達していないときには拡大部β４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βのプランジャ操作側空間の後方薬液６の中間摺動弁βの注射筒内注射針側への移動は生じない。
【００５９】
図１２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。
【００６０】
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。
【００６１】
なお、上記では本発明に係る中間摺動弁βを用いた例を説明したが、本発明に係る中間摺動弁αを用いた場合であっても操作は同様であり、ただし、図１１（ａ）を用いた説明での、中間摺動弁βのプランジャ操作側空間の後方薬液６の後方薬液用通路β１、拡大部β６、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は、図１１（ｂ）に示すように中間摺動弁αの後方薬液用通路である後方薬液入口α１から連通孔α３及び後方薬液出口α２を通過し、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。
【００６２】
また、上記では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、および、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をそれぞれ示したが、例えば図１３（ａ）及び図１３（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。
【００６３】
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１４（ａ）〜（ｆ）に示す。
【００６４】
図１４（ａ）〜図１４（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１４（ｄ）〜図１４（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。これら図中のそれら以外の符号は「’」をつけない図４（ａ）〜図４（ｆ）中の符号にそれぞれ対応する。
【００６５】
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。
【００６６】
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１５（ａ）〜（ｃ）に示す。中間摺動弁β”は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場合がある。
【００６７】
上記中間摺動弁β”を用いる場合には密着防止凸部β５”があるため、注射筒の注射針側底面には後方薬液用通路が設けられている必要がない。ここでそのような注射筒の例１”を図１６（ａ）および図１６（ｂ）に示す。
【００６８】
図１６（ａ）は連通通路１ｃ"を含む断面での断面図、図１６（ｂ）は連通通路１ｃ”を含まない断面での断面図を示す。
上記のような中間摺動弁β”には密着防止凸部β５”があるために、１ｃ”に至った、中間摺動弁β”後方側薬液は密着防止凸部β５”によって確保された中間摺動弁β”と注射筒１”注射針側底面との間を通って注射針接続部１ａ”を通じて注射針（図示しない）に到達できる。
【００６９】
本発明において中間摺動弁は略円柱状であって、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と注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部と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、および、該後方薬液用通路の中間摺動弁進行方向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備えた注射器型キット製剤用中間摺動弁であればよく、上記中間摺動弁の他、例えば図１７に示す中間摺動弁δのような形状のものであっても良い。
【００７０】
図１７（ａ）〜図４（ｃ）には本発明に係る他の中間摺動弁の例δを示す。
図１７（ａ）は側面図、図１７（ｂ）は摺動弁進行方向後方からの斜視図、図１７（ｃ）は摺動弁進行方向前方からの斜視図である。
【００７１】
この中間摺動弁δでは、後方薬液用通路δ１は、中間摺動弁δ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δ２とは独立して設けられており、後方薬液用通路δ１の摺動弁δ進行方向の先端は凹部δ２よりもさらに進行方向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δ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。図中符号δ８は注射筒内壁に接して注射筒の前後の空間を水密に区画するリップ部である。
【００７２】
この中間摺動弁δの後方薬液用通路δ１の中間摺動弁進行方向先頭側に該後方薬液用通路δ１を摺動弁側面周方向に拡大する拡大部δ６は略円筒状の中間摺動弁δの周方向１周するように設けられている。このため、中間摺動弁δは様々なキット製剤用注射筒に対応することができる。
【００７３】
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。
【００７４】
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。
【００７５】
例えば、図１０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。
【００７６】
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。
【００７７】
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。
【００７８】
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。
【００７９】
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。
【００８０】
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。
【００８１】
【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である。
（ｂ）進行方向後方側から見た斜視図である。
【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の側面図である。
（ｂ）中間摺動弁αを進行方向後方側から見た斜視図である。
（ｃ）中間摺動弁αを進行方向前方側から見た斜視図である。
（ｄ）中間摺動弁βの側面図である。
（ｅ）中間摺動弁βを進行方向後方側から見た斜視図である。
（ｆ）中間摺動弁βを進行方向前方側から見た斜視図である。
（ｇ）プランジャ摺動弁γの側面図である。
（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である。
（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である。
【図５】本発明のキット製剤用注射器で用いる注射筒１の例を示す図である。
（ａ）断面図である。
（ｂ）注射針装着側から見た部分斜視図である。
【図６】本発明のキット製剤用注射器で用いる注射筒１’の例を示す図である。
（ａ）断面図（注射針側面液通路を含む断面での断面図）である。
（ｂ）注射針装着側から見た部分斜視図である。
（ｃ）断面図（注射針側面液通路を含まない断面での断面図）である。
【図７】上記注射筒１’の成形で用いる円柱状の中型の一例１０を示すモデル斜視図である。
（ａ）中型全体（樹脂導入時の形状）を示す図である。
（ｂ）スライダを示す図である。
（ｃ）スライダをスライドさせた状態を示す図である。
【図８】上記注射筒１’の成形で用いる円柱状の中型の他の例１０’を示すモデル斜視図である。
（ａ）中型全体（樹脂導入時の形状）を示す図である。
（ｂ）スライダを示す図である。
（ｃ）スライダをスライドさせた状態を示す図である。
【図９】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）側面図である。
（ｂ）進行方向後方側から見た斜視図である。
（ｃ）進行方向前方側から見た斜視図である。
【図１０】（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１１】（ａ）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。
（ｂ）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。
【図１２】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１３】本発明に係る別の摺動弁を示す図である。
（ａ）側面図である。
（ｂ）進行方向後方側から見た斜視図である。
【図１４】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’の側面図である。
（ｂ）中間摺動弁α’を進行方向後方側から見た斜視図である。
（ｃ）中間摺動弁α’を進行方向前方側から見た斜視図である。
（ｄ）中間摺動弁β’の側面図である。
（ｅ）中間摺動弁β’を進行方向後方側から見た斜視図である。
（ｆ）中間摺動弁β’を進行方向前方側から見た斜視図である。
【図１５】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）側面図である。
（ｂ）進行方向後方側から見た斜視図である。
（ｃ）進行方向前方側から見た斜視図である。
【図１６】図１５の中間摺動弁β”を用いたときに使用可能な注射筒の一例１”を示す図である。
（ａ）断面図（注射針側面液通路を含む断面での断面図）である。
（ｂ）断面図（注射針側面液通路を含まない断面での断面図）である。
【図１７】本発明に係る中間摺動弁の他の例を示す図である。
（ａ）側面図である。
（ｂ）進行方向後方側から見た斜視図である。
（ｃ）進行方向前方側から見た斜視図である。
【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]
BACKGROUND OF THE INVENTION
The present invention has an internal sliding valve slidable inside, and another sliding valve (plunger sliding valve or other intermediate sliding valve) in a syringe barrel on the plunger operating side of the intermediate sliding valve. ), A syringe-type kit preparation having a pre-filled drug solution in a space formed therewith, a kit preparation syringe enabling such a kit preparation, and a method of manufacturing a syringe for a kit preparation.
[0002]
[Prior art]
Syringe-type kit preparations are pre-filled with the necessary drug solution in the syringe, so it is not only possible to operate quickly, but it is also necessary to aspirate the drug solution from an ampoule or vial into the syringe barrel as with conventional injections. Therefore, there is no risk of contamination such as glass powder and rubber pieces, and it is an excellent technology having many advantages such as prevention of medical accidents such as infection in advance.
[0003]
Here, for example, two or more kinds of drugs having different physical, chemical or pharmacological properties are required for treatment, but these drugs cannot be used as a mixed solution due to problems such as ensuring stability. (For example, a combination of an acidic drug and an alkaline drug), or in order to give severe pain to the administration site at the time of injection of a therapeutic drug (second drug solution), the second drug solution is administered for the purpose of pain relief. A device in which a local anesthetic is administered as a first drug solution in advance is known.
[0004]
Among these, as the latter example, the first drug solution such as knee osteoarthritis and shoulder periarthritis is a local anesthetic such as lidocaine hydrochloride, the influence of the thickness of the injection needle, the pH and osmotic pressure ratio are the body fluid It is very different, and treatments such as sodium hyaluronate that may cause severe pain to the affected part of the patient due to doctors' inferior techniques, etc. A typical example is a combination with a known induction anesthetic (propofol).
[0005]
As such a syringe-type kit preparation, a syringe-type kit using a serial sequential dispensing type syringe that can be sequentially injected without mixing two or more kinds of drugs in one injection operation by the present inventors. The preparation will be described.
[0006]
Fig.1 (a) is a model figure which shows the example of the syringe type kit formulation using the serial sequential dispensing type syringe which can inject two types of chemical | medical agents by one operation.
[0007]
The syringe of the kit preparation shown here has one intermediate sliding valve 3 ′ and one in a syringe barrel 1 having an injection needle connecting portion 1a at one end and an opening at the other end of the plunger operation side. The plunger sliding valve 2 is housed, and the inside of the syringe barrel 1 is partitioned watertight before and after the sliding valves 2 and 3 ′. Further, the syringe needle mounting portion 1a of the syringe barrel 1 is sealed with a cap 4 made of an elastomeric material, and the first drug solution 5 is placed in the intermediate slide valve 3 'in the syringe needle side space. The space between 3 'and the plunger slide valve 2 is filled with the second chemical 6 respectively. In this example, a detachable plunger operating portion 2 a is attached to the plunger sliding valve 2.
[0008]
In the vicinity of the syringe needle side end on the side surface of the syringe barrel 1 of this syringe, a communication passage 1c is provided in which a part of the side wall protrudes in the radial direction 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 as viewed from the rear side in the traveling direction in FIG. 2 (b). One annular lip 3a 'that goes around in the circumferential direction is provided on the side (rear side in the advancing direction). This annular lip 3a' abuts against the inner wall of the syringe barrel 1, and the space before and after the syringe barrel is partitioned in a watertight manner. is 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 barrel (traveling direction side), and the axis is injected even when the substantially cylindrical intermediate slide valve 3 ′ slides. A holding portion 3 b ′ 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 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 syringe needle side space, the intermediate slide valve, and the plunger slide valve. The chemical solution 5 is filled.
[0010]
Here, when an intermediate sliding valve having two or more annular lips is used instead of the intermediate sliding valve having such a shape, a sealed space formed by the intermediate sliding valve and the inner wall of the syringe barrel 1 is formed. Although air may be trapped and injected into the subject's body by an injection operation, such an inconvenience can be avoided by an intermediate sliding valve having only one annular lip. Further, a convex portion 3c ′ is provided on the bottom surface of the intermediate sliding valve 3 ′ in the traveling direction.
FIG.1 (b) is sectional drawing (model figure) in LL of Fig.1 (a).
[0011]
Prior to use of such a kit preparation, the injection needle 7 is attached to the injection needle connecting portion 1a of the injection cylinder 1 as shown in FIG.
[0012]
At this time, when air bubbles are generated in the first drug solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation portion 2a with the injection needle side up. In addition, when especially reducing the injection amount of the 1st chemical | medical solution 5, the amount of the 1st chemical | medical solution 5 is reduced by operating the plunger operation part 2a at this stage.
[0013]
Next, the injection needle 7 is stabbed into the injection site, and then the plunger operation section 2a is moved to the syringe barrel 1 needle mounting side to inject the first drug solution 5 (see FIG. 3A).
[0014]
Thereafter, when the operation of the plunger operation unit 2a is further continued, the second drug solution 6 is injected into the injection required site. At this time, the intermediate sliding valve 3 ′ moves toward the syringe barrel needle and reaches the tip of the syringe barrel. However, since the convex portion 3c ′ provided on the intermediate slide valve 3 ′ contacts the syringe barrel bottom 1b, Since the intermediate slide valve 3 'does not adhere to the syringe barrel bottom 1b and the communication passage 1c is bypassed, even if these slide valves move toward the syringe barrel bottom 1b, A supply passage to the injection needle 7 is secured.
[0015]
FIG. 3B shows a state (injection completion state) in which the operation of the plunger operation unit 2a is finished and the injection of the second chemical liquid 6 is finished. Usually, the injection needle is removed from the injection site in this state, but when the injection amount of the second drug solution 6 is reduced, the injection needle is inserted in the state where the second drug solution 6 remains in the syringe barrel 1. You can unplug it.
[0016]
In such a serial sequential dispensing syringe type kit formulation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected at the site where the first drug solution 5 is injected. Therefore, even if the second drug solution 6 is greatly different in pH, osmotic pressure, temperature, and the like as compared with the body fluid, the injection can be performed without pain or with less pain.
[0017]
However, such serial sequential dispensing syringes also have drawbacks.
That is, the space between the side surface of the intermediate sliding valve and the inner surface of the syringe barrel becomes a dead volume, and the drug solution existing in this space does not contribute to the injection. Here, some injections are expensive such as several thousand yen to several tens of thousands of yen per ml, and the price may not be negligible. This is particularly noticeable when a large-bore syringe is used when the injection volume per injection is as large as 100 ml as in the case of an X-ray contrast medium.
[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 syringe barrel 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 enlarging the holding part 3b ', if the thickness of the space formed between the side surface of the intermediate sliding valve and the inner surface of the syringe barrel is reduced, the drug solution filling at the time of manufacturing the kit preparation Sometimes the atmosphere gas, such as air, is trapped as bubbles in the space and cannot be easily removed, and the gas may be injected at the time of injection, resulting in frequent defective products and increased productivity. Not only is it reduced, but the reliability as a pharmaceutical kit preparation is also significantly reduced.
[0019]
Here, the syringe itself is a conventional one (one having no communication passage), provided that a hollow portion is provided in the intermediate sliding valve, and the intermediate is made by the pressure of the rear liquid when the front liquid injection operation is completed. A technique has been proposed in which a part of the sliding valve is deformed to form a fluid passage between the side surface and the inner wall of the syringe barrel (Japanese Patent Laid-Open No. 10-57486 (Patent Document 1)). JP, 10-80485, A (patent documents 2)).
[0020]
However, since the formation condition of the fluid passage due to the deformation of the intermediate slide valve depends on the dynamic pressure applied to the intermediate slide valve and the flexibility of the material forming the intermediate slide valve, the formation of the fluid passage is extremely hot. Depending on conditions such as how to apply the operator's force, the viscosity and temperature of the drug, and the thickness of the injection needle to be used, it is always accompanied by the risk of malfunction and its reliability. The performance is extremely low, and it has not been able to sufficiently meet the required performance of reliably sequentially injecting a plurality of drugs in one injection operation.
[0021]
[Patent Document 1]
Japanese Patent Laid-Open No. 10-57486 (page 1-3)
[Patent Document 2]
Japanese Patent Laid-Open No. 10-80485 (page 1-3)
[0022]
[Problems to be solved by the invention]
The present invention improves the above-mentioned conventional problems, that is, it is possible to inject a plurality of medicines sequentially and reliably with a single injection operation, good operability, and possible mixing of bubbles when filling with a chemical solution An object of the present invention is to provide a syringe for kit preparation that has a low dead volume that causes a chemical solution that does not contribute to injection and has a very small dead volume, and an intermediate sliding valve that enables such a syringe for kit preparation.
[0023]
[Means for Solving the Problems]
In order to solve the above-mentioned problem, the syringe for kit preparation of the present invention has a substantially cylindrical shape as defined in claim 1 and is partitioned watertight together with the inner wall of the syringe barrel when inserted into the syringe barrel on the side surface thereof. An intermediate sliding valve having a recess that forms an open space and a lip portion that is in contact with the inner wall of the syringe barrel and divides the space before and after the syringe in a water-tight manner, independently of the recess The intermediate sliding valve among the recesses of the surface in contact with the inner wall of the syringe barrel on the side surface of the intermediate slide valve from the space inside the syringe barrel on the operation side of the intermediate slide valve plunger that is formed when the valve is inserted into the syringe barrel The rear chemical liquid passage extending further to the front side than the most front concave portion in the traveling direction, and the rear chemical liquid passage in the intermediate sliding valve traveling direction leading side of the rear chemical liquid passage in the circumferential direction of the sliding valve side surface An intermediate slide valve with an enlarged portion that expands is slidable inside the syringe barrel, In the vicinity of the injection needle side end of the inner wall of the syringe barrel, when the intermediate slide valve reaches the most injection needle side in the syringe barrel, it is connected to the rear drug solution passage of the intermediate slide valve, and A communication passage capable of bypassing the intermediate sliding valve and supplying the liquid medicine on the plunger operating side of the intermediate sliding valve to the syringe needle side of the intermediate sliding valve when connected to the rear chemical liquid passage; It is a syringe for kit preparations.
[0024]
With such a configuration, while the sliding resistance is reduced by the recess formed on the side surface of the intermediate sliding valve, the water-tight space formed by the recess and the inner wall of the syringe barrel is not filled with the chemical solution, which is wasteful. In addition, since the rear chemical liquid passage is provided independently of the concave portion, there is no possibility that air or the like enters the passage.
[0025]
In addition, since the tip of the rear drug solution passage is provided on a surface of the side surface of the intermediate slide valve that contacts the inner wall of the syringe barrel, the slide valve itself slides in the syringe barrel and reaches the vicinity of the syringe needle side end. Unless 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 barrel, the chemical liquid behind the intermediate sliding valve is supplied in the forward direction of the intermediate sliding valve. Nevertheless, it is extremely reliable. Furthermore, since the rear chemical solution passage is further to the top side of the concave portion than the most concave portion in the traveling direction of the intermediate slide valve, the communication passage and the rear chemical solution in a state where the communication passage and the concave portion are not connected to each other. It is possible to ensure the connection with the passage. At that time, the gas existing in the space between the recess and the inner wall of the syringe barrel does not connect with the communication passage. Yes.
[0026]
In the present invention, the movement of the intermediate slide valve in the syringe barrel is caused by the pressure applied via the rear drug solution, but the rear drug solution passage is connected to a communication passage provided near the injection needle side end of the syringe barrel inner wall. Since the pressure suddenly drops at the moment, the movement of the intermediate sliding valve is not performed before the cross-sectional area of the connecting portion 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. It may stop, and a very large force may be required for the subsequent operation of the plunger.
[0027]
In order to eliminate such an inconvenience, it is desirable to provide an enlarged portion that enlarges the rear chemical liquid passage in the circumferential direction of the sliding valve side surface at the foremost side of the rear chemical liquid passage in the intermediate sliding valve traveling direction.
Here, in the case of the above purpose, when a syringe barrel having a wide communication passage that reaches or makes one round of the circumferential direction of the inner wall of the syringe barrel is used, the rear drug solution passage of the intermediate slide valve is used. However, when the width of the communication passage of the syringe barrel is narrow, it can be dealt with by making the enlarged portion larger. That is, the enlarged portion is sufficiently wide with respect to the intermediate sliding valve circumferential direction, preferably 60 ° or more, more preferably 90 ° or more (120 ° or more, or 180 ° or more). Therefore, the types of kit syringes that can be handled can be increased.
[0028]
DETAILED DESCRIPTION OF THE INVENTION
The intermediate sliding valve in the present invention is not a sliding valve that is directly driven by a plunger, but a sliding valve that is indirectly driven by a chemical solution on the rear side in the traveling direction. An intermediate slide having a recess that forms a watertight compartment with the inner wall of the syringe barrel when inserted into the syringe barrel and a lip portion that is in contact with the inner wall of the syringe barrel and divides the space before and after the syringe barrel in a watertight manner An intermediate sliding valve from a space in the syringe barrel on the operation side of the intermediate slide valve plunger formed when the intermediate slide valve is inserted into the syringe barrel independently of the recess. It is necessary to provide a rear medicinal solution passage that is further in contact with the inner wall of the syringe barrel on the side surface and that is further to the front side than the most front side concave part in the advancing direction of the intermediate sliding valve.
[0029]
An example α of the intermediate sliding valve according to the present invention is shown in FIGS. 4 (a) to 4 (c).
4A is a side view, FIG. 4B is a perspective view from the rear in the sliding valve traveling direction, and FIG. 4C is a perspective view from the front in the sliding valve traveling direction. The intermediate sliding valve α is used as a rear chemical liquid passage, and a rear chemical liquid inlet α1 that opens into a syringe operating space on the plunger operation side that is formed when the intermediate sliding valve α is inserted into the syringe. Of the recesses on the side of the valve operating side that is in contact with the inner wall of the syringe barrel, the foremost side of the recesses α4 (there is only one in this example, but there may be a plurality of them) The rear chemical solution outlet α2 that opens at a location, and the communication hole α3 that is formed in the sliding valve α itself that connects the rear chemical solution inlet α1 and the rear chemical solution outlet α2 are formed. The rear chemical liquid passage is provided independently of the concave portion α4 provided for the purpose of improving the slidability of the intermediate sliding valve. Reference numeral α8 in the drawing denotes a lip portion that is in contact with the inner wall of the syringe barrel and partitions the space before and after the syringe barrel in a watertight manner.
[0030]
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. It is usually sufficient if the cross-sectional area of the rear drug solution passage is equal to or larger than the cross-sectional area of the inner diameter of the injection needle to be used, and if the condition is satisfied, one rear drug solution passage is sufficient. The smaller the volume of the rear chemical solution passage, the smaller the amount of the remaining chemical solution.
[0031]
An enlarged portion α7 that expands the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve on the leading side of the intermediate sliding valve traveling direction of the rear chemical liquid passage of the intermediate sliding valve α is a substantially cylindrical intermediate sliding valve α. It is provided so as to make one round in the circumferential direction. For this reason, as will be described later, the intermediate sliding valve α can correspond to various syringes for kit preparations.
[0032]
4 (d) to 4 (f) show an example β of another 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.
[0033]
In this intermediate slide valve β, the rear chemical liquid passage β1 is provided in a groove shape on the side surface of the intermediate slide valve β, and a recess β2 provided for the purpose of improving the slidability of the intermediate slide valve and Are provided independently, and the tip of the rear chemical liquid passage β1 in the moving direction of the sliding valve β is located further on the front side in the moving direction than the recess β2. Also 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 β. It is usually sufficient if the cross-sectional area of the rear drug solution passage is equal to or greater than the cross-sectional area of the inner diameter of the injection needle to be used. If this condition is satisfied, one rear drug solution passage is sufficient. The smaller the volume of the chemical liquid passage, the smaller the amount of chemical liquid remaining. Reference numeral 8 in the drawing denotes a lip portion that is in contact with the inner wall of the syringe barrel and partitions the space before and after the syringe barrel in a watertight manner.
[0034]
An enlarged portion β6 that expands the rear chemical liquid passage β1 in the circumferential direction of the side surface of the sliding valve on the front side in the intermediate sliding valve traveling direction of the rear chemical liquid passage of the intermediate sliding valve β is a substantially cylindrical intermediate sliding valve β. It is provided so as to make one round in the circumferential direction. For this reason, as will be described later, the intermediate sliding valve β can correspond to various syringes for kit preparations.
[0035]
4 (g) to 4 (i) show a normal plunger sliding valve (sliding valve directly driven by the plunger) γ.
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.
[0036]
The plunger slide valve is provided with a recess γ1 for reducing the sliding resistance like the slide valves α and β, but is not provided with a rear chemical liquid passage. In addition, γ2 is a fitting hole that fits into the fitting portion at the distal end of the injection needle side of the plunger operation portion (not shown).
[0037]
The intermediate sliding valve according to the present invention as described above is slidably accommodated in the syringe barrel 1 as shown in a sectional view in FIG. 5A and in a perspective view in FIG. .
The syringe barrel 1 has an injection needle connection portion 1a at the center of the bottom surface on the injection needle side at one end, and an opening at the plunger operation side end at the other end.
[0038]
Near the injection needle side end of the inner wall of the syringe barrel 1, the intermediate slide valve according to the present invention is connected to the rear drug solution passage of the intermediate slide valve when reaching the most injection needle side in the syringe barrel, and When connected to the rear drug solution passage, the intermediate slide valve is bypassed so that the drug solution on the plunger operating side of the intermediate slide valve can be supplied to the syringe needle side of the intermediate slide valve A passage 1c is provided. In this example, the communication passage 1c is provided so as to make a round in the circumferential direction of the inner wall of the syringe barrel 1. However, like the slide valve α or β according to the present invention described above, the rear drug solution passage is a substantially cylindrical intermediate. When three are provided so as to be equiangular (120 °) with respect to the sliding valve, it is sufficient if they are provided so that the circumferential direction exceeds 120 ° (for example, 130 to 140 °). .
[0039]
Further, when the intermediate slide valve is located closest to the injection needle on the bottom of the syringe barrel 1, the intermediate slide valve is connected to the in-cylinder injection needle side (intermediate slide valve) by the communication passage 1c connected to the rear drug solution passage. Groove-shaped injection needle side surface liquid for supplying the liquid medicine on the plunger operating side (backward in the intermediate sliding valve advance direction) of the intermediate sliding valve supplied to the forward direction (forward direction) to the liquid introduction hole 1a1 to the injection needle. Four passages 1d are provided at the same angle (90 °) with respect to the substantially cylindrical syringe barrel 1 on the bottom surface of the syringe barrel 1 on the injection needle side. However, it is usually sufficient to provide one injection needle side liquid passage 1d, and the cross-sectional area of the passage is equal to or greater than the cross-sectional area of the inner diameter of the injection needle to be used (preferably 1.5 times to 2 times) is usually sufficient, and the smaller the amount, the smaller the amount of remaining chemical solution.
The syringe barrel 1 has an injection needle connecting portion 1a at the center of the bottom surface on the injection needle side at one end and an opening at the plunger operation side end at the other end.
[0040]
The syringe barrel 1 shown in FIGS. 5A and 5B is provided with the communication passage 1c so as to go around the inner wall circumferential direction of the syringe barrel 1. However, the intermediate slide valve of the present invention is shown in FIG. 6 (a) and a syringe barrel as shown in FIG.
FIG. 6 (a) shows a cross-section (cross-sectional view taken along the plane including the communication passage 1c ′), and FIG. 6 (b) shows a narrow perspective view of the communication passage 1c ′. A groove-shaped injection needle side surface liquid passage 1d ′ connected to a liquid introduction hole 1a1 ′ to the injection needle 1 ′ provided on the bottom surface of the injection cylinder 1 ′ at the injection needle side end of the inner wall of the cylindrical injection cylinder Are provided at positions that are 180 ° with respect to the center line of the cylinder of the syringe barrel.
FIG. 6C is a cross-sectional view of the syringe barrel 1 ′, but is a cross-sectional view on a surface that does not include the communication passage 1c ′.
[0041]
An enlarged portion α7 that expands the rear drug solution passage in the circumferential direction of the slide valve side surface at the front side in the intermediate slide valve traveling direction of the rear drug solution passage of the intermediate slide valve α with respect to the syringe barrel 1 ′ is substantially cylindrical. If the intermediate sliding valve α is provided so as to extend over about 180 ° in the circumferential direction, when the intermediate sliding valve reaches the most injection needle side in the syringe barrel 1 ′, the intermediate sliding valve The liquid medicine on the plunger operating side can be reliably supplied to the syringe needle side of the intermediate sliding valve.
[0042]
Even if the width of the communication passage is narrow, for example, there are three communication passages on the inner side of the inner wall of the cylindrical syringe barrel at positions 120 ° relative to the center line of the cylinder of the syringe barrel, or 90 ° relative to each other. The expansion part that expands the passage for the rear chemical solution provided in the intermediate slide valve in the circumferential direction of the side surface of the slide valve by providing four at the positions and six at the positions at 60 ° to each other is substantially cylindrical. It is sufficient if the intermediate sliding valve α is provided so as to occupy about 120 ° or more, 90 ° or more, or 60 ° or more in the circumferential direction.
[0043]
By such an enlarged portion, it becomes possible to make the formation of the communication passage to the inner wall of the syringe barrel, which requires a device for molding in one injection molding, easier by improving the degree of freedom of its shape, The cost of the injection mold can be reduced, and the cost of the syringe can be lowered.
[0044]
Here, the method for forming the syringe barrel 1 ′ will be briefly described with reference to FIGS. 7 and 8 showing a cylindrical middle mold.
The syringe barrel 1 'can supply a chemical solution on the plunger operating side of the slide valve to the side of the syringe needle in the syringe barrel in the vicinity of the syringe needle side end of the syringe barrel inner wall. This is a syringe for a kit preparation in which a communication passage is formed by a recess, and this is a manufacture of a syringe for a kit preparation that is molded by introducing a resin into a cavity formed between an outer mold and a cylindrical middle mold. Manufactured by the method.
[0045]
Here, FIGS. 7 (a) and 8 (a) schematically show different types of cylindrical middle dies 10 and 10 ', respectively.
These columnar medium molds have a plurality of split mold sections (two split mold sections 10a in the case of the medium mold shown in FIG. 7A, and four split mold sections 10a in the case of the medium mold shown in FIG. 8A). And each of the split mold parts 10a or 10a ', and the cylindrical middle mold 10 or 10' together with the split mold parts 10a or 10a '. A slider portion 10b (see FIG. 7 (b)) or 10b ′ (see FIG. 7B) that forms a side bottom surface and a surface that forms the inner side surface of the syringe barrel and is slidable on the plunger syringe plunger operation side. 8 (b)).
[0046]
The slider portions 10b (see FIG. 7B) and 10b ′ (see FIG. 8B) are so-called tapered shapes that become thicker toward the syringe plunger operation side (right side in the drawing). Is inversely tapered, thinning accordingly.
[0047]
The two split mold parts 10a are provided with both, and two of the four split mold parts 10a ′ are provided with communication path forming convex parts 10a1 and 10a1 ′ for forming the communication path, respectively. After the resin introduced into the cavity is cured or solidified, as shown in FIG. 7 (c) or FIG. 8 (c), the slider portion 10b and the slider portion 10b ′ having a tapered shape are disposed on the syringe plunger operation side (FIG. 7 (c). ), All the split mold parts 10a or 10a ′ including the split mold part provided with the communication path forming convex part are retracted in the space formed by sliding in the direction of the solid arrow in FIG. 7 (c) and FIG. 8 (c) indicate the direction thereof), and the engagement between the communication passage forming convex portion 10a or 10a ′ and the formed communication passage of the syringe barrel is released. Note manufactured after By taking out the cylinder, it is possible to obtain the kit preparation for injection tube 1 'as shown in FIG.
[0048]
In the above, since the slider portion is tapered and the split mold portion is inversely tapered, the slide portion of the syringe barrel in which the convex portion for forming the communication passage is formed simply by sliding in the space between the split mold portions. The engagement with the communication path is released, but the slider portion may be slid so as to be completely removed from the space between the split mold portions. In this case, the taper-shaped shape of the slider portion and the split mold portion A reverse tapered shape is not always necessary.
[0049]
FIG. 9A to FIG. 9C show Example 2 of the plunger sliding valve used together.
9A is a side view, FIG. 9B is a perspective view from the rear in the sliding valve traveling direction, and FIG. 9C is a perspective view from the front in the sliding valve traveling direction.
[0050]
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 the chemical remaining between these sliding valves can be reduced. In addition, a fitting hole (shown as a model) that fits in the fitting portion at the distal end of the plunger operating portion (not shown) of the plunger operating portion (not shown) is visible at the center of the rear surface in the traveling direction of the intermediate sliding valve in FIG. It is.
[0051]
FIG. 10 (a) shows an example of a syringe-type kit preparation using the serial sequential dispensing syringe according to the present invention prepared using the intermediate sliding valve β, the syringe barrel 1 ′ and the plunger sliding valve 2 as described above. Is shown in model cross-sectional view.
[0052]
The kit preparation shown in FIG. 10 has a syringe barrel 1 ′ having an injection needle connecting portion 1a ′ at one end and an opening at the other end of the plunger operation side (shown in FIGS. 6A to 6C). ), One intermediate sliding valve β (shown in FIGS. 4 (d) to (f)) and one plunger sliding valve 2 are slidably housed inside the syringe barrel 1 ′. Is divided in watertight by these intermediate slide valve β and plunger slide valve 2 before and after. Further, the syringe needle mounting portion 1a ′ of the syringe barrel 1 ′ is sealed with a cap 4 made of an elastomeric material, and the first drug solution 5 is intermediately slid in the syringe barrel side space of the intermediate slide valve β. The space between the valve β and the plunger slide valve 2 is filled with the second chemical liquid 6.
[0053]
Prior to use of such a kit preparation, an injection needle 7 is attached to the injection needle connecting portion 1a ′ of the injection cylinder 1 ′ as shown in FIG. 10 (b) (in addition to the injection needle 7, a tube, a stopcock) Accessories may be connected). A plunger operating portion 2 a is attached to the plunger sliding valve 2.
[0054]
At this time, when air bubbles are generated in the first drug solution 5 by an injection needle mounting operation or the like, the air bubbles can be removed by operating the plunger operation portion 2a with the injection needle side up. In addition, when especially reducing the injection amount of the 1st chemical | medical solution 5, the amount of the 1st chemical | medical solution 5 is reduced by operating the plunger operation part 2a at this stage.
[0055]
Next, the injection needle 7 is stabbed into the injection required site, and then the operation of moving the plunger operating portion 2a to the injection cylinder 1 ′ injection needle side is performed to inject the first drug solution 5 (see FIG. 10C).
[0056]
Thereafter, when the operation of the plunger operation unit 2a is further continued, the second drug solution 6 is injected into the injection required site. At this time, the intermediate slide valve β moves to the syringe barrel injection needle side and reaches the tip of the syringe barrel (most side of the syringe needle) (see FIG. 11A).
[0057]
At this time, the rear drug solution passage β1 of the intermediate slide valve β is connected to the communication passage 1c ′ provided near the injection needle side end of the inner wall of the syringe barrel 1 through the enlarged portion β6, and further the communication passage 1c ′. Is connected to an injection needle side liquid passage 1d 'provided on the bottom surface of the syringe barrel 1', so that the rear chemical solution 6 in the plunger operation side space of the intermediate slide valve β is a rear chemical solution passage β1, an enlarged portion. It is introduced into the injection needle through β4, the communication passage 1c ′, and the injection needle side surface fluid passage 1d ′.
[0058]
When the intermediate slide valve β does not reach the tip of the syringe barrel 1, the enlarged portion β4 is sealed by the inner surface of the syringe barrel 1 ′, so that the middle of the rear drug solution 6 in the plunger operation side space of the intermediate slide valve β is provided. The sliding valve β does not move toward the injection needle in the syringe.
[0059]
FIG. 12 shows a state (injection completion state) in which the operation of the plunger operation unit 2a is finished and the injection of the second drug solution 6 is finished. Normally, the injection needle is removed from the injection site in this state, but when the injection amount of the second drug solution 6 is reduced, the injection needle is injected with the second drug solution 6 remaining in the syringe barrel 1 ′. It may be removed from the site.
[0060]
In such a serial sequential dispensing syringe type kit formulation, when the first drug solution is a local anesthetic and the second drug solution is a therapeutic drug, the second drug solution is injected at the site where the first drug solution 5 is injected. Therefore, even if the second drug solution 6 is greatly different in pH, osmotic pressure, temperature, and the like as compared with the body fluid, the injection can be performed without pain or with less pain.
[0061]
In addition, although the example using the intermediate sliding valve β according to the present invention has been described above, the operation is the same even when the intermediate sliding valve α according to the present invention is used, except that FIG. In the explanation using a), injection through the rear chemical liquid passage β1, the enlarged portion β6, the communication passage 1c ′, the injection needle side liquid passage 1d ′ of the rear chemical liquid 6 in the plunger operation side space of the intermediate slide valve β. As shown in FIG. 11 (b), the needle is introduced from the rear chemical solution inlet α1, which is the rear chemical solution passage of the intermediate slide valve α, through the communication hole α3 and the rear chemical solution outlet α2, and through the communication passage 1c ′, injection. It is introduced into the injection needle through the needle side surface fluid passage 1d ′.
[0062]
Further, in the above, in the intermediate sliding valve β according to the present invention, an example of the introduction of the rear liquid of the intermediate sliding valve by the groove provided on the side surface of the intermediate sliding valve as the rear chemical liquid passage, and the intermediate sliding according to the present invention. Examples of the introduction of the rear fluid of the intermediate sliding valve by the communication hole that has opened the intermediate sliding valve itself as the rear chemical fluid passage by the valve actuating α are shown in FIGS. 13 (a) and 13 (b), for example. As shown in the figure, the rear fluid of the intermediate sliding valve may be introduced by using the groove and the communication hole together as the passage for the rear chemical solution (the order of the groove and the communication hole may be reversed). Of course, this is also included in the present invention.
[0063]
The syringe cylinder 1 used above has 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. For example, a groove-like injection needle side liquid passage may be provided on the front side surface in the traveling direction of the intermediate sliding valve, and examples of such an intermediate sliding valve are shown in FIGS. .
[0064]
14 (a) to 14 (c) shows an example α of the intermediate sliding valve according to the present invention, α ′ provided with a groove-like injection needle side liquid passage α6 ′ on the front side surface in the traveling direction of the intermediate sliding valve. 14 (d) to 14 (f), β ′ provided with a groove-like injection needle side liquid passage β4 ′ on the front side surface in the traveling direction of the intermediate slide valve in an example β of the intermediate slide valve according to the present invention. Indicates. Symbols other than those in these figures correspond to the symbols in FIGS. 4A to 4F without “′”.
[0065]
By means of a groove-shaped injection needle side liquid passage provided on the front side surface in the direction of travel of these intermediate slide valves, the intermediate slide valve reaches the most injection needle side in the injection cylinder, and the injection needle side surface is the injection cylinder injection needle. The liquid flow between the communication passage provided near the injection needle side end of the inner wall of the syringe barrel and the liquid introduction hole to the injection needle provided on the syringe barrel injection needle side bottom surface also when closely attached to the side bottom surface Is secured. The cross-sectional area of the injection needle side surface fluid passage is preferably equal to or larger than the inner diameter cross-sectional area of the used injection needle. In the above example, there are three injection needle side liquid passages, but one is usually sufficient.
[0066]
Further, instead of the groove-shaped injection needle side surface fluid passage, even when the intermediate sliding valve moves to the most injection needle side, it does not adhere to the injection needle side bottom surface of the syringe barrel, and from the communication passage to the injection needle. A convex portion may be provided on the front side surface in the traveling direction of the intermediate sliding valve so as to ensure the liquid flow, and such an example is shown in FIGS. The intermediate sliding valve β ″ is provided with an adhesion preventing convex portion β5 ″ that prevents adhesion to the bottom surface of the syringe barrel injection needle even when the intermediate slide valve reaches the most injection needle side in the syringe barrel. β ″ is provided on the front side surface of the intermediate sliding valve in the direction of travel. However, securing the liquid passage by the adhesion prevention convex portion tends to increase the dead volume more than the other examples described above, and the amount of the chemical solution that is wasted at that time May increase.
[0067]
When the intermediate sliding valve β ″ is used, since there is an adhesion preventing convex portion β5 ″, there is no need to provide a rear drug solution passage on the injection needle side bottom surface of the syringe barrel. FIG. 16A and FIG. 16B show an example 1 ″ of such a syringe barrel.
[0068]
FIG. 16A is a cross-sectional view in a cross section including the communication passage 1c ″, and FIG. 16B is a cross-sectional view in a cross section not including the communication passage 1c ″.
Since the intermediate sliding valve β ″ as described above has the adhesion preventing convex portion β5 ″, the intermediate sliding valve β ″ rear side chemical liquid that has reached 1c ″ is secured by the adhesion preventing convex portion β5 ″. The injection needle (not shown) can be reached through the injection needle connecting portion 1a "through between the sliding valve β" and the injection cylinder 1 "injection needle side bottom surface.
[0069]
In the present invention, the intermediate sliding valve has a substantially cylindrical shape, and when inserted into the syringe barrel on its side surface, the syringe barrel is in contact with the recess and the syringe barrel inner wall forming a watertight space together with the syringe barrel inner wall. In the intermediate slide valve for a syringe-type kit preparation having a lip portion that tightly partitions the front and rear spaces of the syringe, the intermediate slide valve is formed when the intermediate slide valve is inserted into the syringe barrel independently of the recess. From the space in the syringe barrel on the operation side of the intermediate slide valve plunger to the side in contact with the syringe barrel inner wall on the side of the intermediate slide valve, further forward than the recess on the most leading side in the intermediate slide valve traveling direction among the recesses. For a syringe-type kit having a rear drug solution passage extending to the side, and an enlarged portion that expands the rear drug solution passage in the circumferential direction of the slide valve side surface at the leading side of the rear drug solution passage in the intermediate sliding valve traveling direction Any intermediate sliding valve may be used. Or it may be shaped like a middle sliding valve δ shown in FIG. 17.
[0070]
17 (a) to 4 (c) show another example δ of the intermediate sliding valve according to the present invention.
17A is a side view, FIG. 17B is a perspective view from the rear in the sliding valve traveling direction, and FIG. 17C is a perspective view from the front in the sliding valve traveling direction.
[0071]
In the intermediate sliding valve δ, the rear chemical liquid passage δ1 is provided in a groove shape on the side surface of the intermediate sliding valve δ, and a recess δ2 provided for the purpose of improving the slidability of the intermediate sliding valve. Are provided independently, and the tip of the rear chemical liquid passage δ1 in the moving direction of the sliding valve δ is located further on the leading side in the moving direction than the recess δ2. Also 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 δ. Reference numeral δ8 in the figure is a lip portion that contacts the inner wall of the syringe barrel and divides the space before and after the syringe barrel in a watertight manner.
[0072]
An enlarged portion δ6 that expands the rear chemical liquid passage δ1 in the circumferential direction of the side surface of the sliding valve on the front side in the intermediate sliding valve traveling direction of the rear chemical liquid passage δ1 of the intermediate sliding valve δ is a substantially cylindrical intermediate sliding valve. It is provided so as to make one round in the circumferential direction of δ. For this reason, the intermediate sliding valve δ can correspond to various syringes for kit preparations.
[0073]
Here, as an application example of the syringe for a kit preparation as described above, there is a kit preparation for an X-ray contrast medium.
That is, two or more spaces that are watertightly partitioned by an intermediate sliding valve or a plunger sliding valve inserted into the syringe barrel are filled with a chemical solution in advance, and the chemical solutions 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 a drug solution having no X-ray contrast agent after discharge of the drug solution having the X-ray contrast agent Is an X-ray contrast medium kit preparation.
[0074]
At this time, the medicinal solution having no X-ray contrast agent is various effects because it is one or a mixture of two or more selected from physiological saline, blood substitutes other than physiological saline, vitamins, and distilled water. can get.
[0075]
For example, in the kit preparation shown in FIG. 10, 70 mL of an X-ray contrast agent is filled as the first drug solution 5, and physiological saline, blood substitutes other than saline, vitamins, distilled water are used as the second drug solution The mixture is filled with 30 mL of one kind or a mixture of two or more kinds. 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 (salt chloride) Sodium / glucose, etc.), glucose / dextran, maintenance liquid (sodium lactate / inorganic salts / sugar), postoperative recovery liquid, dehydration replenisher, Ringer's acetate, Ringer's solution, mannitol combination, and the like. That is, the second drug need not have a large medicinal / physiological effect, and has the following three main purposes.
[0076]
1. An X-ray contrast medium is often introduced into a subject's body via an extension tube or a catheter. The internal volume of the tube and catheter becomes a dead volume, and the chemical solution remains. Therefore, in the case of a kit preparation, it is necessary to fill the necessary amount to be introduced into the body plus the dead volume. However, the X-ray contrast medium is very expensive at about 20,000 yen per 100 ml, and it is not economical to fill it in excess. Here, as an X-ray contrast agent for the first drug solution, only the necessary amount to be introduced into the subject's body is filled, and even if it is introduced into the body (or blood vessel) as the second drug solution, there is no problem in pharmacological / physiological aspects. It is possible to select an object and “push out” the entire required amount including the first liquid remaining in the tube into the subject's body.
[0077]
Note that the plunger operation for introducing the X-ray contrast agent is performed in the X-ray imaging room, and thus is performed by automatic / remote control by an automatic injector. For example, serial sequential dispensing as described above is performed. By using the type injector, the operation by the conventional automatic injector is possible, and it is not necessary to purchase a new automatic injector.
[0078]
Furthermore, since it is a kit preparation as described above, it is not necessary to open the drug container, suction into the syringe, etc., and there is no concern about foreign matter contamination, bacterial / viral contamination, etc. Because there is no need to use both, it is possible to prevent bacterial and virus contamination from the stopcocks and operational errors in advance.
[0079]
2. The contrast agent remaining in the vein or venous valve after the introduction of the X-ray contrast agent may coagulate, and may cause thrombophlebitis. By introducing this, the residual of these contrast agents is prevented.
[0080]
3. It is possible to quickly extrude (flash) the contrast medium into the body, improve the contrast effect of the main blood vessels, and reduce the appearance of artifacts around the vein (virtual image). 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.
[0081]
【The invention's effect】
The syringe for a kit preparation of the present invention can reliably and sequentially inject a plurality of drugs in one injection operation, has good operability, has a low possibility of mixing bubbles when filled with a drug solution, and is injected. It is an excellent syringe for kit preparation that has a very small dead volume that causes a chemical solution that does not contribute to the drug.
[Brief description of the drawings]
BRIEF DESCRIPTION OF DRAWINGS FIG. 1 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 which shows the state with which the injection needle was mounted | worn.
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) It is the perspective view seen from the advancing direction back side.
FIG. 3 (a) is a diagram showing a state in which the injection of the first drug solution 5 is completed.
(B) It is a figure which shows the state (injection completion state) which operation of the plunger operation part 2a was complete | finished and injection of the 2nd chemical | medical solution 6 was complete | finished.
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) It is a side view of intermediate slide valve alpha.
(B) It is the perspective view which looked at the intermediate slide valve (alpha) from the advancing direction back side.
(C) It is the perspective view which looked at the intermediate | middle sliding valve alpha from the advancing direction front side.
(D) It is a side view of the intermediate slide valve β.
(E) It is the perspective view which looked at the intermediate | middle sliding valve (beta) from the advancing direction back side.
(F) It is the perspective view which looked at the intermediate slide valve (beta) from the advancing direction front side.
(G) It is a side view of plunger sliding valve (gamma).
(H) It is the perspective view which looked at the plunger slide valve (gamma) from the advancing direction back side.
(I) It is the perspective view which looked at the plunger slide valve (gamma) from the advancing direction front side.
FIG. 5 is a view showing an example of a syringe barrel 1 used in the syringe for kit preparation of the present invention.
(A) It is sectional drawing.
(B) It is the fragmentary perspective view seen from the injection needle mounting side.
FIG. 6 is a view showing an example of a syringe barrel 1 ′ used in the kit preparation syringe of the present invention.
(A) It is sectional drawing (sectional drawing in a cross section containing a syringe side surface liquid channel | path).
(B) It is the fragmentary perspective view seen from the injection needle mounting side.
(C) It is sectional drawing (sectional drawing in the cross section which does not contain an injection needle side surface liquid channel | path).
FIG. 7 is a model perspective view showing an example 10 of a cylindrical medium mold used for forming the syringe barrel 1 ′.
(A) It is a figure which shows the whole middle mold (shape at the time of resin introduction).
(B) It is a figure which shows a slider.
(C) It is a figure which shows the state which made the slider slide.
FIG. 8 is a model perspective view showing another example 10 ′ of a cylindrical middle size used for forming the syringe barrel 1 ′.
(A) It is a figure which shows the whole middle mold (shape at the time of resin introduction).
(B) It is a figure which shows a slider.
(C) It is a figure which shows the state which made the slider slide.
FIG. 9 is a view showing an example of a plunger slide valve used in the syringe for kit preparation of the present invention. (A) It is a side view.
(B) It is the perspective view seen from the advancing direction back side.
(C) It is the perspective view seen from the advancing direction front side.
FIG. 10 (a) is a model diagram showing a syringe-type kit preparation using a serial sequential dispensing syringe according to the present invention that can inject two kinds of drugs in one operation.
(B) It is a figure which shows the state with which the injection needle 7 and the plunger operation part 2a were mounted | worn.
(C) It is a figure which shows the state which injection of the 1st chemical | medical solution 5 was complete | finished.
FIG. 11 (a) is a partially enlarged cross-sectional view showing the flow of the second chemical liquid when the intermediate sliding valve β according to the present invention is used.
(B) It is a partial expanded sectional view which shows the mode of the flow of the 2nd chemical | medical solution when the intermediate sliding valve (alpha) which concerns on this invention is used.
FIG. 12 is a diagram showing a state (injection completion state) in which the operation of the plunger operation unit 2a is completed and the injection of the second drug solution 6 is completed.
FIG. 13 is a view showing another sliding valve according to the present invention.
(A) It is a side view.
(B) It is the perspective view seen from the advancing direction back side.
FIG. 14 is a view showing intermediate sliding valves α ′ and β ′ in which a groove-shaped injection needle side liquid passage is provided on the front side surface in the traveling direction of the intermediate sliding valve.
(A) It is a side view of intermediate | middle sliding valve (alpha) '.
(B) It is the perspective view which looked at intermediate sliding valve alpha 'from the advancing direction back side.
(C) It is the perspective view which looked at intermediate sliding valve alpha 'from the advancing direction front side.
(D) It is a side view of intermediate | middle sliding valve (beta) '.
(E) It is the perspective view which looked at intermediate sliding valve (beta) 'from the advancing direction back side.
(F) It is the perspective view which looked at intermediate sliding valve (beta) 'from the advancing direction front side.
FIG. 15 is a view showing an intermediate sliding valve β ″ having an adhesion prevention convex portion for preventing adhesion to the bottom surface of the syringe barrel injection needle even when the syringe barrel reaches the most side of the injection needle.
(A) It is a side view.
(B) It is the perspective view seen from the advancing direction back side.
(C) It is the perspective view seen from the advancing direction front side.
16 is a view showing an example 1 ″ of a syringe barrel that can be used when the intermediate sliding valve β ″ of FIG. 15 is used.
(A) It is sectional drawing (sectional drawing in a cross section containing a syringe side surface liquid channel | path).
(B) It is sectional drawing (sectional drawing in the cross section which does not contain an injection needle side surface liquid channel | path).
FIG. 17 is a view showing another example of the intermediate sliding valve according to the present invention.
(A) It is a side view.
(B) It is the perspective view seen from the advancing direction back side.
(C) It is the perspective view seen from the advancing direction front side.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Injection cylinder 1a Injection needle connection part 1c Communication path 2 Plunger sliding valve 2a Plunger operation part alpha, beta Intermediate sliding valve 4 Cap 5 1st chemical | medical solution 6 2nd chemical | medical solution 7 Injection needle

Claims (8)

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と注射筒内壁に接して注射筒の前後の空間を水密に区画する１つのリップ部と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、および、該後方薬液用通路の中間摺動弁進行方向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、該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。It is substantially cylindrical, and when inserted into the syringe barrel on its side, it forms a watertight compartment with the inner wall of the syringe barrel and a space before and after the syringe barrel in contact with the inner wall of the syringe barrel. An intermediate sliding valve having one lip portion that is formed when the intermediate sliding valve is inserted into the syringe barrel independently of the recess. A passage for a backward medicinal solution from the inner space of the syringe barrel to the front side further than the most front side concave portion in the intermediate slide valve advancing direction of the concave portion of the surface contacting the syringe barrel inner wall of the side surface of the intermediate slide valve, and An intermediate sliding valve having an enlarged portion that expands the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve is slidable inside the syringe barrel on the leading side of the rear chemical liquid passage in the traveling direction of the intermediate sliding valve. 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 drug solution passage of the intermediate slide valve, and the rear When connected to the medicinal solution passage, the intermediate slide valve is bypassed and a communication passage capable of supplying the medicinal solution on the plunger operating side of the intermediate slide valve to the syringe needle side of the intermediate slide valve is provided. A syringe for a kit preparation characterized by the above. 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, further comprising an adhesion prevention convex portion that prevents adhesion to the bottom surface of the syringe barrel injection needle even when the intermediate slide valve reaches the most injection needle side in the syringe barrel. 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。  The intermediate slide valve is provided near the injection needle side end of the inner wall of the syringe cylinder even when the intermediate slide valve reaches the most injection needle side in the syringe cylinder and the side surface of the injection needle is in close contact with the bottom surface of the syringe cylinder injection needle side. The intermediate sliding valve is provided with an injection needle side liquid passage that secures a liquid flow between the communication passage and the liquid introduction hole to the injection needle provided on the bottom surface of the syringe barrel injection needle. Item 2. The syringe for kit preparation according to Item 1. 上記中間摺動弁の後方薬液用通路の中間摺動弁進行方向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が中間摺動弁周方向６０°以上に亘って設けられていることを特徴とする請求項１ないし請求項３のいずれかに記載のキット製剤用注射器。  An enlarged portion that expands the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve extends over 60 ° or more in the circumferential direction of the intermediate sliding valve on the leading side of the intermediate chemical valve in the moving direction of the intermediate sliding valve. The syringe for kit preparation according to any one of claims 1 to 3, wherein the syringe is provided. 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と注射筒内壁に接して注射筒の前後の空間を水密に区画する１つのリップ部と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、および、該後方薬液用通路の中間摺動弁進行方向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。It is substantially cylindrical, and when inserted into the syringe barrel on its side, it forms a watertight compartment with the inner wall of the syringe barrel and a space before and after the syringe barrel in contact with the inner wall of the syringe barrel. An intermediate slide valve for a syringe-type kit preparation having a single lip portion, wherein the intermediate slide valve is formed when the intermediate slide valve is inserted into the syringe barrel independently of the recess. For the backward medicinal solution from the space inside the syringe barrel on the plunger operation side to the top side of the concave portion on the side of the intermediate slide valve that is in contact with the inner wall of the syringe barrel, further to the top side than the most concave portion in the intermediate slide valve traveling direction. An intermediate for a syringe-type kit preparation comprising a passage and an enlarged portion that expands the rear drug solution passage in the circumferential direction of the side surface of the slide valve on the leading side of the rear drug solution passage in the intermediate slide valve traveling direction Sliding valve. 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請求項５に記載の注射器型キット製剤用中間摺動弁。  The rear drug solution passage includes a rear drug solution inlet that opens into the space in the syringe barrel on the plunger operation side that is formed when the intermediate slide valve for syringe-type kit preparation is inserted into the syringe barrel, The rear chemical solution outlet that opens to the top side of the concave portion on the surface in contact with the inner wall of the syringe barrel that opens further to the front side than the most leading concave portion in the advancing direction of the intermediate sliding valve, and the rear chemical solution inlet and the rear chemical solution outlet communicate with each other 6. The intermediate slide valve for a syringe-type kit preparation according to claim 5, wherein the intermediate slide valve is formed by a communication hole bored in the intermediate slide valve for a syringe-type kit preparation. 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５に記載の注射器型キット製剤用中間摺動弁。  6. The intermediate slide valve for a syringe-type kit preparation according to claim 5, 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. 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と注射筒内壁に接して注射筒の前後の空間を水密に区画する１つのリップ部と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、および、該後方薬液用通路の中間摺動弁進行方向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、該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。It is substantially cylindrical, and when inserted into the syringe barrel on its side, it forms a watertight compartment with the inner wall of the syringe barrel and a space before and after the syringe barrel in contact with the inner wall of the syringe barrel. An intermediate sliding valve having one lip portion that is formed when the intermediate sliding valve is inserted into the syringe barrel independently of the recess. A passage for a backward medicinal solution from the inner space of the syringe barrel to the front side further than the most front side concave portion in the intermediate slide valve advancing direction of the concave portion of the surface contacting the syringe barrel inner wall of the side surface of the intermediate slide valve, and An intermediate sliding valve having an enlarged portion that expands the rear chemical liquid passage in the circumferential direction of the side surface of the sliding valve is slidable inside the syringe barrel on the leading side of the rear chemical liquid passage in the traveling direction of the intermediate sliding valve. 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 drug solution passage of the intermediate slide valve, and the rear When connected to the medicinal solution passage, the intermediate slide valve is bypassed and a communication passage is provided that can supply the medicinal solution on the plunger operating side of the intermediate slide valve to the syringe needle side of the intermediate slide valve A syringe-type kit preparation characterized in that a drug solution is filled in at least a plunger operation side space of an intermediate sliding valve of a syringe barrel of a syringe for kit preparation.
JP2002294581A 2002-10-08 2002-10-08 Syringe for kit preparation, intermediate sliding valve for syringe-type kit preparation, syringe-type kit preparation, and method for producing syringe for kit preparation Expired - Fee Related JP3976658B2 (en)

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