JP4026871B2

JP4026871B2 - Syringe combining two chambers

Info

Publication number: JP4026871B2
Application number: JP13017296A
Authority: JP
Inventors: 茂杉原
Original assignee: Daikyo Seiko Ltd
Current assignee: Daikyo Seiko Ltd
Priority date: 1996-05-24
Filing date: 1996-05-24
Publication date: 2007-12-26
Anticipated expiration: 2016-05-24
Also published as: JPH09308688A

Description

【０００１】
【発明の属する技術分野】
本発明は、注射筒の内部を２室にした注射器に関し、詳しくは各室内にそれぞれ規定量の医薬品を安定に保存でき、投与の際には各室内を連通させて、一方の室内の薬品を他方の室内に移動させることにより両者を混合し、溶解液にしてそのまま投与できる２室を結合した注射器の改良に関する。
【０００２】
【従来の技術】
注射器の筒内部に投与すべき薬剤、薬液を予め収納・保存しておいて、緊急時に速やかに衛生的に投与できる容器兼用の注射器が知られている。このような注射器を用いる薬剤として、不安定なもの、力価が高く規定価が定められているもの、混合薬などは不適当であった。
そこで注射筒の内部のほぼ中央に設置した滑栓により筒内部を２室に分離し、４注射筒の先端側の室の壁に細い注入溝を設けておき、滑栓を押棒により圧入することにより該注入溝をバイパスとして２室を連通させて２室内の薬品を混合する技術が開発された。例えば実公昭４９−１４４６５号が知られており、これをさらに改良した技術として特開昭５８−６１７５５号、特開昭６２−５３５７号、特開昭６２−１４８６３号、特開平１−８０３７１号、特開平４−２４６３６４号、特開平５−１３９７７号、特開平６−７４４６号、特開平６−１８１９８５号、特開平７−１３６２６７号、特開平７−２６５４２３号、特開平７−３９５８２号、実開平５−８６５３５号各号公報等がある。
【０００３】
一方、特開昭５１−１１６９１号、米国特許第４，０３１，８９２号明細書には、粉末薬と溶解薬とを別個の二つの容器内に収納し、両容器を隣接して結合し、両薬を安定に保存しておき、使用の際には二つの容器を封止しているゴム栓を両頭針で貫通し、該両頭針の中程に設けられた開口を使用して両薬品を混合溶解する技術が提案されている。
【０００４】
また新たに、実開平５−１５２号には、２つの円筒体の連なる二室容器からなる注射器の注射筒内壁に細いバイパス溝を設けて、該バイパス溝を通路として両薬品に混合して溶解するタイプの注射器が提案されている。このタイプのものの改良技術として例えば特開平６−１４２２０３号、特開平７−１３６２６４号、特開平７−１３６２６７号、特開平７−１４８２６１号、特開平７−２９９１４１号公報等があり、２つの円筒体が一体となり、各室内に充填した薬品の品質を保持できる形態を有している。いずれの公知技術にも、日進月歩の医療、医薬品業界に対応し得る注射器とするための研究努力が表われている。
【０００５】
【発明が解決しようとする課題】
本発明は上記従来技術の更なる改良を目的とするものであって、製剤工程においてコンパクトな装置で容易かつ衛生的に薬品充填及び容器結合操作が行えること、各室内に充填した薬品の品質保持性が向上すること、容器の結合程度を任意に選択できること、といった要求を満たす構造を有する２室を結合した注射器を課題としている。
【０００６】
【課題を解決するための手段】
本発明は、（１）から（９）を要旨とする。
（１）注射針部、略円筒状で先端が注射針部の取り付部であり後端が第１密封栓で封止される合成樹脂からなる容器ａ、略円筒状で先端を第２密封栓で後端を第３密封栓でそれぞれ封止される合成樹脂からなる容器ｂ、及び押棒を有し、該容器ａ内部に固形薬が及び該容器ｂ内部には液状薬が充填されており、該容器ａの後端と該容器ｂの先端が気密に結合して一体化され、使用時には該押棒により該第３密封栓を先端側に押し込み該第１密封栓、第２密封栓及び第３密封栓を先端側に移動することにより該容器ａと該容器ｂとを連通する流路を形成し、該容器ｂ内の薬と該容器ａ内の薬を混合・溶解して投与できるように２室を結合した注射器において、上記容器ａの後端近傍の外周面に後端に向かい筒外径が減少するテーパ部と該テーパ部に続く鍔状突起とを設け、かつ該容器ｂの先端の内周面には先端側から後端に向かい該テーパ部とこれに続く該鍔状突起に対応する形状の断面鉤爪状の突起と該鉤爪状突起に続く凹部とを設けてあり、該容器ａ後端が該容器ｂ先端に嵌入して、該テーパ部と該鍔状突起とが該断面鉤爪状突起と該凹部とに係合することにより該容器ａ及び該容器ｂが気密に結合されてなることを特徴とする上記注射器。
（２）上記容器ｂの断面鉤爪状の突起が容器先端側から切れ込んだ１本以上のノッチを有することを特徴とする（１）に記載の注射器。
（３）上記容器ａの本体外径Ｄ₁，内径ｄ₁と上記容器ｂの本体外径Ｄ₂，内径ｄ₂において、Ｄ₁＝Ｄ₂、かつｄ₁≧ｄ₂であることを特徴とする（１）又は（２）に記載の注射器。
（４）上記容器ａの本体外径Ｄ₁，内径ｄ₁と上記容器ｂの本体外径Ｄ₂，内径ｄ₂において、Ｄ₁＞Ｄ₂、かつｄ₁＞ｄ₂であることを特徴とする（１）又は（２）に記載の注射器。
（５）上記容器ａと上記容器ｂの結合部分の外周に環状カバーを設けて上記ノッチ部分及び又は該容器ａと該容器ｂの外周の段差部分を覆うことを特徴とする（１）又は（４）のいずれかに記載の注射器。
（６）上記容器ａの後端部と上記鍔状突起の間が筒状の開口面壁を形成し、該開口面壁の内壁部には筒軸に対し垂直な断面において複数個の凹窪を有してなることを特徴とする請求項１ないし（５）のいずれかに又は以上２記載の注射器。
（７）上記容器ａの先端は、本体より小さい内径の管状の先端部が突出し、該本体内部と該先端部内部を該先端部内径と同じかより小さい内径の通路で連通してなることを特徴とする（１）ないし（６）のいずれかに記載の注射器。
（８）上記容器ａの先端部の開口部を逆Ｕ字型のゴム栓で気密に封止するとともに、該先端部外周に円筒体を取り付け、該円筒体内には該円筒体内部を摺動可能な針基を有する両頭針を取り付けてなる（１）ないし請求項７のいずれかに記載の注射器。
（９）上記第１密封栓、第２密封栓、第３密封栓及び該逆Ｕ字型のゴム栓のそれぞれ薬と接触する表面が、薬に不活性な合成樹脂製フィルムで積層されてなることを特徴とする請求項１ないし（８）のいずれかに記載の注射器。
【０００７】
【発明の実施の形態及び実施例】
以下に、本発明の構造とその作用機構を詳細に説明するが、本明細書においては２つの円筒容器のうち、注射針を取り付け部に近い方から容器ａ、容器ｂとし、また各円筒容器においては注射針に近い端部を先端、これとは反対側の端部を後端という。
本発明は円筒体の内部（室）に薬品を充填して封止した容器ａ及び容器ｂを直列に配し、容器ａ後端と容器ｂ先端が結合してなる容器兼注射器において、容器ａ後端近傍の外周面に後端に向かい筒外径が減少するテーパ部と該テーパ部に続く鍔状突起を設け、一方容器ｂの先端の内周面には該テーパ部及び該鍔状突起に対応する断面鉤爪状の突起（以下鉤爪状突起という）及び凹部を設けて、該テーパ部と該鉤爪状突起、該鍔状突起と該凹部とを係合させることにより、該該テーパ部と該鍔状突起とが形成する窪部に該鉤爪状突起がくいこんで確実に係合させたことを第１の特徴としている。
【０００８】
図１は本発明の一実施態様を示す断面図であり、注射針を取り付ける管状に突出した先端部４を有する円筒状の容器ａ（以下「筒ａ」とも略記する）と、該容器ａの末端に結合する円筒状の容器ｂ（以下「筒ｂ」とも略記する）とが直列に結合されて一体の容器を兼ねた注射器１を構成する状態を示す。筒ａには濃縮薬、凍結乾燥薬、粉末薬、顆粒薬、錠剤、結晶及びこれらの混合薬などの固形の薬品（以下、「濃縮薬」と総称する）１１を、筒ｂには溶解液、分散液、生理用食塩水、注射用蒸留水などの液状薬（以下、「薬液」と総称する）１２が気密に充填されている。
【０００９】
該筒ａは本体２と本体２から突出した細い管状の先端部４を有する。該先端部４の開放口には逆Ｕ字型のゴム栓５を打栓して封止する。該ゴム栓５の薬品、濃縮薬１１と接触する面には、薬品に不活性な合成樹脂製フィルム７を積層してゴム素材の濃縮薬汚染を防止している。また、断面が略Ｈ字型のキャップ６にて該ゴム栓５の開口部を封じるとともに、該ゴム栓５を先端部４に固定している。該ゴム栓５、該キャップ６は該筒ａから外すことなく、そのままの状態で注射針を装着できる構造になっている。また、該筒ａの後端内部には第１密封栓８が配置される。該ゴム栓５と該第１密封栓８との間に形成される空間（室）内に濃縮薬１１を充填し、該ゴム栓５と該第１密封栓８により密封して容器内を完全に気密に保持し、長期間にわたり濃縮薬１１の品質を維持する。該第１密封栓８は弾性体からなり、上記のように筒内を密封できるとともに、該筒ａ内を摺動できる。
【００１０】
また、該筒ａの本体２の内壁面には、筒軸方向の略中央部から始まり筒軸方向に沿って該第１密封栓８の先端部分に隣接する位置まで凹溝状の不連続部１３が設けられ、該不連続部１３の筒軸方向長さは、該第１密封栓８と後述する筒ｂの内部に配置した第２密封栓９の各筒軸方向長さの合計よりも大きくしてある。
【００１１】
該筒ｂの本体３の先端側内部には第２密封栓９を密嵌し、後端側内部には第３密封栓１０を密嵌する。該第２密封栓９及び該第３密封栓１０もまた弾性体からなり密封性を有するとともに、該筒ｂ及び該筒ａ内を摺動可能である。該第２密封栓９と該第３密封栓１０との間に形成される室内に薬液１２を水密に収容している。また、該筒ｂの後端内部の第３密封栓１０の後部には、図示は省略した押棒を係合するためのネジ窪１４を設ける。該筒ｂの後端部分において内壁に図示のように環状突起を設け、ゴム栓１５を打栓することによって、該第３密封栓１０を安定に配置できるとともに、該筒ｂ内の気密性をより向上できる。
【００１２】
以上の該第１密封栓８、該第２密封栓９及び該第３密封栓１０の該濃縮薬１１や該薬液１２に接する表面も、それぞれ薬品に不活性な合成樹脂製フィルム７で積層して薬品への汚染を防止している。
【００１３】
上記該第１密封栓８, 第２密封栓９及び第３密封栓１０は、密封性と共に該筒ａ、該筒ｂ内における摺動性も確保できるように、その材質、形状を十分に考慮して選択することが望ましい。すなわち、高圧蒸気滅菌のような高温から凍結乾燥の際の−５０℃といった低温に至る広い温度範囲において変形することなく、かつ液漏れがないこと、室内部を長期にわたり気密に密封できること、使用時には筒内部をスムースに摺動できること、という要件を満たす材質及び構造となっている。材質については後述する。また、構造については、該第１、第２及び第３密封栓８，９，１０の該筒ａ又は該筒ｂの内壁と接触する面にリブを３個以上設けて、該筒内壁との密封性と摺動性という矛盾した特性を両立させている。また、表面に合成樹脂フィルムを積層したリブ無し密封栓を使用することによっても、密封性と摺動性を両立させることが可能である。なお、上記ゴム栓５の材質、構造についても同様に配慮する。
【００１４】
次に本発明の第１の特徴である筒ａと筒ｂの結合について具体的に説明する。図２は該筒ａ、該筒ｂの結合部分近辺の構造を説明するための概略図であって、図２の（ａ−１）部分は該筒ａの末端部の軸方向断面を、（ａ−２）部分は（ａ−１）部分を矢印Ａの方向から俯瞰した図を示し、また（ｂ−１）部分は該筒ｂの先端部の筒軸方向断面を、また（ｂ−２）部分は（ｂ−１）部分を矢印Ｂ方向から俯瞰した図を示す。さらに図３において（ａ）は該筒ａの斜視図、（ｂ）は該筒ｂの内部の部分切欠き斜視図、（ｃ）は該筒ａと該筒ｂの結合を説明するための部分断面図を示す。
【００１５】
該筒ａの後端近傍の外周面において後端に向かって外径が減少するようにテーパをつけたテーパ部１６を設ける。該テーパ部１６の最小外径部分において該筒ａの本体２の外径Ｄ₁よりは若干小さい外径ではあるが該テーパ部１６の最小外径よりは大きい外径の鍔状突起１７を設け、該鍔状突起１７から後端側は該鍔状突起１７の外径よりは小さい外径の開口面壁１９を形成する。該テーパ部１６の最小外径部分と該鍔状突起１７の間に（ａ−１）部分に示すように窪部が形成される。
【００１６】
該筒ｂの先端内周面においては、該テーパ部１６と該鍔状突起１７、該開口面壁１９にその断面が対応するように、先端端部からテーパをつけてその断面が鉤爪状の突起である鉤爪状突起２０、及び凹部を有する外周壁２２を設けておく。該筒ａ後端部分が該筒ｂ先端部分に嵌入するようにして、該鍔状突起１７と該鉤爪状突起２０を係合することにより該筒ａ及び該筒ｂをを確実、強固に結合し一体化できる。
【００１７】
図１ないし図３に示した実施例においては、該筒ａの末端の開口面壁１９を凸型とし、該筒ｂの先端を凹窪形として、該筒ａの本体２の外径Ｄ₁，内径ｄ₁と、該筒ｂの本体３の外径Ｄ₂，内径ｄ₂をそれぞれ同等にした。
ところで、該鉤爪状突起２０に続く該外周壁２２を厚くすることは、該筒ｂの強度を高めることになるが、結合操作の際の摺動性の自由度を低下させる。そこで筒の材質を強度の高いものにしてあまり該外周壁２２を厚くはせずに、該鉤爪状突起２０にノッチ（細い切れ込み）２１を設けることが好ましい。本例ではノッチ２１を３本設けてある。
【００１８】
また、本実施例では該鉤爪状突起２０の高さを０．１〜０．８ｍｍに、また該鍔状突起１７の筒軸に垂直な方向の長さ（筒からの突出長さ）を０．１〜０．８ｍｍに設計して、該筒ａと筒ｂの分離が困難な強い結合を実現している。
このように本発明の構造によれば、該鍔状突起１７の高さ（筒軸方向長さ）と半径方向への突出長さ、該鉤爪状突起の高さと軸方向長さ、筒の材質の強度を選択することにより、一度係合すると分離することが困難な強い結合から、分離が比較的容易にできる程度の結合まで、種々の結合強さを自由に選択できる。
【００１９】
密封性向上のためには、さらに、該筒ａ、該筒ｂの間に図１に示すようにＯリング状のパッキン５５を配置することも望ましい。
【００２０】
次に、本発明の第２の特徴である容器ａ末端部内周面の構造を図２及び図３により説明する。濃縮薬の製剤に非常に好適な容器とするために、図２及び図３に示すように該筒ａの該開口面壁１９の開口端面から後端内壁面にかけて複数個の凹窪１８を切欠く。該凹窪１８の深さは５〜１２ｍｍ、幅は２〜５ｍｍが好ましい。
【００２１】
該凹窪１８の作用を図４により説明する。図４は、該筒ａ内への濃縮薬の製剤工程中の状態を示す部分断面図である。図示は省略したが先端部４を密閉した該筒ａを真空濃縮のできる室又は凍結乾燥できる室（槽）内の固定具または棚２４に固定または載置する。該筒ａ内に原料混合薬液２３を仕込み、末端部に第１密封栓８を該凹窪１８の深さの半分の位置まで打栓した状態、すなわち半打栓状態にして減圧雰囲気下に保持にする。このとき図示の例では該第１密封栓８の２番目のリブの下端は該筒ａの開口面壁１９の開口端面において該凹窪１８を切り欠いていない部分の上に係止している。原料混合薬液２３からの溶媒等の蒸気２５は、該凹窪１８が該第１密封栓８との間に形成する通路を経て排出されて、原料混合薬液２３は濃縮、乾燥し濃縮薬となる。濃縮、乾燥が終了した時点で、減圧下において打栓棒２６等により該第１密封栓８を完全に打栓する。これにより濃縮乾燥及び打栓密封工程を完全に滅菌室で行うことが、極めて容易となり、製剤工程の衛生性及び操作性向上に大いに寄与できる。
【００２２】
また、真空濃縮工程等を必要としない薬品の注射器兼容器として本発明を適用する場合には、本発明の第１の特徴である筒ａ及び筒ｂの結合部分を上記のようにするだけで、凹窪１８を設けなくてもよい。このような本発明の注射器を適用するのに好適な例としては、一般に２室タイプの注射器兼容器が使用される薬品の組合せ、例えば投与直前に混合することが好ましい薬品の組合せの場合、また制癌剤、抗生物質等とアルキル化剤又はホルモン剤等の組合せのように多剤併用により相乗効果が得られる場合などが挙げられる。
【００２３】
筒ｂ内への薬液の製剤は公知技術に従って行なう。簡単に説明すると、まず筒ｂ、第２密封栓及び３密封栓を洗浄及び乾燥して、微粒子や雑菌等を除去しておく。該筒ｂ先端側に該第２密封栓９を打栓した後、精製、ろ過した規定量の薬液を充填し、次いで筒内に空気（酸素）等が残留しないように真空下で該第３密封栓１０を打栓する。その後、例えば蒸気温度１２０〜１３０℃で１０〜２０分間等の条件で高圧蒸気滅菌を行なう。
【００２４】
上記で得られた濃縮薬を製剤した該筒ａを固定しておき、該筒ａの筒軸方向の延長線上に、薬液を製剤した該筒ｂの筒軸方向を合わせて配置し、該筒ｂを該筒ａに向かって直線方向に移動させるだけで、該筒ａの鍔状突起と該筒ｂの鉤爪状突起が係合して強固に結合できるので、簡単、確実に該筒ａと該筒ｂの一体化が実現できる。勿論該筒ｂを固定しておいて該筒ａを該筒ｂに向かって移動させてもよい。従来の結合構造では別器具を使用して組み合わせる複雑な工程を要した。また、２本の円筒体を螺合により結合する構造は、円筒体の直線方向運動と回転運動の組合せを必要とする。これに比べ本発明の結合構造は上記のように筒ａと筒ｂの組み立てが直線方向の相対的移動のみ（ワンストローク）であるため極めて容易であり、この操作は公知の装置を用いてクリーンルームで無人で操作することができるし、また組立て装置も低廉なもので済むという大きな利点を有する。
【００２５】
次に、本発明の注射器の使用方法を説明する。図５は筒ｂ内の薬液１２を筒ａの内部に移動して濃縮薬１１と混合している状態を示す概略断面図である。すなわち、該筒ｂ後部の第３密封栓１０のネジ窪１４に押棒２７の先端のねじを取り付け、該押棒２７を該筒ｂの内部へ押し込むことによって、薬液１２を介して圧力が伝わり、第２密封栓９は第１密封栓８とほぼ一緒に筒ａ内に移動し、該第１密封栓８及び第２密封栓９が不連続部１３に達する。不連続部１３は筒ａの本体２の内壁面に彫り込まれた筒軸方向に延びる細い凹溝であり、その長さは第１密封栓８と第２密封栓９の筒軸方向長さの合計より長くなるように設計してあるので、第１密封栓８及び第２密封栓９は不連続部１３の中に嵌まりこむ。一方不連続部１３の反対側の筒内壁面には突起２８を設けてあるので、第１密封栓８の先端はこの突起２８で一時係止する。また押棒に環状の段３０を設けてこの一時係止位置で一端押し込みを止める目印にする。これにより筒ａの先端にまで空気を完全に移動せしめると共に、不連続部１３が該筒ａ内と該筒ｂ内を連通する流路を形成する。該流路を経由して筒ｂ内の薬液１２が該筒ａ内に流入して濃縮薬１１を溶解し、筒ａ内で規定の力価、濃度に調整された注射薬となる。次に該筒ａの先端部４にゴム栓５及びキャップ６をつけたまま両頭針２９を針基３１により図示のように取り付けて、更に押し棒を押し込むことにより、筒ａ内先端の空気を両頭針２９の針穴より完全に押し出した後、汎用注射器と同様の操作により、注射薬を投与する。
【００２６】
図６は本発明の注射器の筒ａの不連続部１３の種々の実施態様の横断面を示す図であり、（ａ）は図１のａ−ａ′横断面を示し、筒ａの本体２の室内には濃縮薬１１が収納され、不連続部１３は筒軸方向に沿った凹溝３２となっている。
（ｂ）は図５のｂ−ｂ′横断面を示し、筒ａの本体２内部には第１密封栓８及び第２密封栓９が位置しており、不連続部１３の凹溝３２を通路として筒ｂ内からの薬液１２が流れている状態を示す。
（ｃ）は筒ａの壁内面に断面三角形の突起３３と谷部が連続することにより不連続部を形成している別の実施態様を示す断面図であり、該突起３３に当接することにより第１密封栓８，第２密封栓９が変形することにより該谷部は通路となり、その中を薬液１２が流れることができる。
（ｄ）は筒ａの外周壁の厚さを変えることなく筒軸方向に沿った細い山形に突出させて溝部を形成して不連続部３４とした本発明の他の実施態様を示す断面図である。
（ｅ）は（ｄ）と同様に形成された２本の不連続部３４を対称位置に設け薬液１２の通路とした本発明の他の実施態様を示す断面図である。
【００２７】
図７は本発明の注射器のさらに他の実施例を示す断面図である。本実施例では筒ａの本体３５の外径Ｄ₁と、筒ｂの本体３６の外径Ｄ₂が、Ｄ₁＞Ｄ₂となる関係にある。該筒ａ（３５）は両端をゴム栓３７と第１密封栓８で封止し、該筒ｂ（３６）は第２密封栓９と第３密封栓１０にて封止された容器である。また該筒ａ（３５）の後端は凸形を呈し、該筒ｂ（３６）の前末端は、図１の例と同様にテーパ部１６、鍔状突起１７及びこの両者の境界に形成される窪部並びに該筒ｂ（３６）の断面が鉤爪状の突起（以下、鉤爪状突起）２０及び外周面壁２２を嵌合しかみ合わせることにより、単純な直線移動のみで強固かつ気密に結合できるようにしてある。
【００２８】
図７の該筒ａ（３５）の特徴は小分けされた濃縮薬を製剤するために好適な構造を有する点である。該筒ａ（３５）の後端においては、図１に示される凹窪１８は設けていない。本実施例では、図８に示すように、キャップ状で天面中央に穴を開けた補助器具３９を被せて、該補助器具３９の天面穴に第１密封栓８を嵌入係止した状態で濃縮工程に付す。該補助器具３９の円筒側壁部分には貫通孔３９が開けてあり、図示は省略した原料混合薬液からの蒸気２５は該貫通孔３８から排出される。なお、２６は打栓棒である。
【００２９】
図７の該筒ａ（３５）、該筒ｂ（３６）の本体部分の各外径Ｄ₁，Ｄ₂及び内径ｄ₁，ｄ₂において、Ｄ₁＞Ｄ₂，ｄ₁＝ｄ₂であり、筒ａ（３５）の外径及び壁厚を大きく設計してある。該筒ａ（３５）の不連続部は筒の軸方向に沿って筒壁の厚さを変えることなく彫り込んだ不連続部４０を形成してある。これは薬液の流路となる部分である。またこのように筒ａ（３５）の壁厚を大きくすることにより、環境、空気、酸素、湿度、紫外線の影響を防止する効果が向上する。
【００３０】
また、図示は省略したが該筒ａの内径を該筒ｂの内径の１０１〜１０４％と太くすることにより、第２密封栓９の摺動性を容易にする効果を有する。さらにまた、ｄ₁＝ｄ₂と内径をほぼ同じにし、外径をＤ₁＞Ｄ₂またはＤ₁＜Ｄ₂と設計することもできる。該筒ｂの本体の壁厚を大きくするこにより、外周面に溝を設けてここに指掛けフランジ４１を取り付けることや、また指すべり防止のために表面に凹凸４３を広い幅で設けることも容易になる。該フランジ４１と表面の該凹凸４３は薬投与の際に、押棒２７を押すための指かけ台となり、操作を確実にして注射針の刺し誤りを防ぐ。
【００３１】
本発明では該筒ａ（３５）と筒ｂ（３６）の間に、リング状のパッキン５７を配置することにより、密封性を向上できる。ところで、図７の例のように筒ａと筒ｂの外径が異なる例では、図９のように結合部分に若干の段差を生ずる。また、筒ｂにはノッチ４４を設けることもあるので、環状カバー５６で該段差部分及びノッチ４４部分を外側から包み被せることにより、該筒ａと該筒ｂの結合を強め、外観を良くする効果が得られる。
【００３２】
図７の該筒ａ（３５）の注射器の先端部４では、本体部でｄ₁であった内径が非常に細い通路４５に狭められた後に、管状に突出した先端部の内部において再び図示のように広い内部室４３を形成するよう拡げられている。図示の例では細い内径部分は径が０．０５〜０．４２ｍｍ、筒軸方向長さが１〜８ｍｍに設けられている。先端部（内部室）の開口は図８に断面図を示す逆Ｕ字形ゴム栓３７で封止し、キャップ５４の付いた注射針５２が取り付けられている。
【００３３】
該筒ａ（３５）の先端部の通路４５を細くすることにより、該筒ａ（３５）内に濃縮薬を製剤する際の原料混合薬液の粘度を適当なものに調整しておくと、該原料混合薬液の通路４５への流入を防止できる。このようにすると、該筒ｂの薬液と混合の際に不溶解部分が発生することを防止できる。ただし、該通路４５を過度に狭く、長くすると、押棒圧入による薬液の流入速度を低下させてしまうので、原料混合薬液粘度と通路４５のサイズを充分に検討、調整すべきである。
【００３４】
なお、図８に示すように該筒ａ（３５）の先端に取り付ける該ゴム栓３７の薬品に接する面には薬品に対し不活性な合成樹脂フィルム７を積層して内容物への汚染を防止する。また、該ゴム栓３７の内壁面には環状の突起４７を、外周面にも環状の突起４８を設けて、密封性を向上し該筒ａ内の濃縮薬１１の長期の保存に特に好適な形態とするとともに、両頭針で該ゴム栓３７を刺通してガラス内部室４７内に貫入する際のガイドとしての機能を持たせた。更にゴム素材にも公知技術を深く検討して製品化を行った。
【００３５】
図７の該筒ａの先端は細く突出し、該突出部５３に円筒体４９を固定し、該円筒体４９内部には、針基５０に取り付けられた両頭針５２が収められる。該針基５０は円筒体４９の内壁を摺動できるものである。注射器中の薬液を人体に投与する際には、針カバー５４を外し、該両頭針５２の針基５０の先端部５１を抑えて、該円筒体４９の内部にその内壁に沿って押し込むと、該両頭針５２の後端は該ゴム栓３７の内部突起４７に誘導されて移動することによりゴム栓３７の底を貫通し、該両頭針５２の後部針先５３は先端内部４６に流出してきた薬液に到達する。すなわち、薬液は通路４５、内部４６と流れて、押棒の圧力によって両頭針５２の内部を経て流出する。本発明による製品は、製剤された注射器の一部に両頭針をセットしてあり、該両頭針の針先は針カバー５４で衛生的に保護してあるので、移動、運搬による悪影響を受けない。
【００３６】
本発明の注射器は容器として薬剤を保存している状態においては筒ａと筒ｂを完全に分離し、水分（湿度）が濃縮薬に影響しない構造になっているので、力価の高い濃縮薬を長期安定保存できる。また、緊急時には簡単に包装を解いて、押棒を圧入することにより内部に充填してあった薬を混合して規定濃度、力価の溶液となった薬液を調整すると共に、セットされている両頭針から直ちに投与できるので、操作ミスなく衛生性高く投与できる。
さらに、本発明の注射器は、０．２ｍｌ〜１ｍｌの小容量から２０〜５０ｍｌという大容量の注射器のいずれにも適用でき、コンパクトで携帯するのにも好適な構造である。
【００３７】
なお、筒ａ、筒ｂの結合手段に、従来の市販品のように、市販接着剤あるいはセロハン製テープ、合成樹脂系テープなどを採用すると、これらに含有される低揮発性成分や有害物、不純物等からの汚染が憂慮されるが、本発明ではこのような危険性は全く存在しない。
【００３８】
本発明の注射器、容器の本体を構成する素材としては、成形性を考慮すると合成樹脂であり、また薬品を汚染しないものが好ましい。例えば環状オレフィン系化合物又は架橋多環式炭化水素化合物を重合成分とする樹脂、ポリエチレン、ポリプロピレン、ポリカーボネート、ポリメチルペンテン、ポリエステル樹脂などの１種以上を用いることが好ましい。また、２種以上の合成樹脂材料を積層することも好ましい。この場合は、薬に接する面に前記の薬品汚染のない合成樹脂を用い、薬に接しない層として若干特性の異なる合成樹脂を用いることが好ましい。後者の合成樹脂としては例えばポリスルホン、ポリアリレート、変性フェニレンオキシド樹脂、ポリアミド、ポリビニルアルコール、ポリ酢酸ビニルなどが挙げられる。前者の樹脂と後者の樹脂の混合物あるいはアロイ化物等は特に好ましい樹脂として推奨できる。合成樹脂表面に酸化ケイ素、酸化アルミニウム、酸化マグネシウムなどを蒸着したものは、酸素、空気、水分（湿度）に対するバリアー作用があり、注射器内に充填した薬品の品質を保持して長期保存するために好適である。
【００３９】
本発明注射器は０．２〜１ｍｌという小容量から５０ｍｌ程度の大容量まで広いサイズ範囲に適合でき、しかも大容量の筒内に収納した、吸湿性大で易酸化性の不安定や薬についても３〜５年間という長期保存を実現することを目指した。この目的のために、本発明の第１、第２、第３密封栓は高い密封栓と摺動性の両立が要求される。その材質としてはこの種分野で用いられる公知のものを用いることができる。また材質の物理的特性としては、例えばＪＩＳ硬度３０近傍の比較的軟かい材質で、耐熱性を有し、圧縮歪のない加熱ゴム弾性体、例えば１００℃で圧縮歪量約１０％のゴム弾性体などが好ましい。例えばイソブチレン−イソプレン共重合ゴム（ＩＩＲ）、ＩＩＲの塩素化ゴム、ＩＩＲの臭素化ゴム、イソブチレン−イソプレン−ジビニルベンゼン三元共重合ゴムなども好ましいものとしてが挙げられる。
またゴム材質による薬汚染防止のために積層される合成樹脂製フィルムの材質としては、例えば四フッ化エチレン樹脂、三フッ化塩化エチレン樹脂、四フッ化エチレン−六フッ化プロピレン共重合樹脂、フッ化ビニリデン樹脂、フッ化ビニール樹脂、四フッ化エチレン−エチレン共重合樹脂、三フッ化塩化エチレン−エチレン共重合樹脂等を挙げることができる。
また密封栓の形状としては、筒内壁との摺動部分に環状のリブを３個以上設けたものが好ましい。その他、この種の分野における公知技術を最高度に適用することが望ましい。また、逆Ｕ字形ゴム栓についても密封栓の場合と同様のゴム弾性体、及び合成樹脂製フィルム積層を用いることが好ましい。
【００４０】
【発明の効果】
以上説明したように、本発明は２本の円筒状容器内に薬品を収納した注射器であり、容器ａの後端の鍔状部及びテーパ部と、容器ｂの先端の断面が鉤爪状の突起部で直列に結合する構造を有することにより、
1) 製剤工程において、２本の円筒状容器を直線移動させることにより、簡単に確実かつ強固に結合できること、
2) 上記1)の結合方法は簡単であるため、クリンルーム内、滅菌室内などの複雑な環境条件下でも実施が容易であり、装置及び運転に経費がかからず経済効果が大きいこと、
3) ２種類の薬品を別個に各容器内に製剤しておいてから結合できるで、薬品の安定性及び製剤工程の簡略化が可能であり、安全性、衛生性、経済性の上で非常に有利であること、
4) 容器を気密に構成できてしかも壁厚さの厚い構造も採用できるため、高度の耐吸水性、気密性があるので、不安定で力価規定がある濃縮薬の保持に特に好適であること、
5) ２本の円筒状容器において、投与する薬液を衛生的に簡単、迅速に混合、調整できて直ちに使用できる構造であること、
6) 結合部分がコンパクトであり、注射器全体がコンパクトに構成できるので、携帯用としても好適であること、
という効果を奏する。
【図面の簡単な説明】
【図１】本発明の一実施例を説明する概略断面図である。
【図２】図１の筒ａと筒ｂの結合部分の構造を説明するための図である。
【図３】図１の筒ａと筒ｂの結合部分の構造を説明するための図である。
【図４】図１の筒ａに濃縮薬を製剤する工程を説明するための概略断面図である。
【図５】図１の筒ｂ内の薬液を筒ａ内に移送する状態を説明するための概略断面図である。
【図６】本発明の注射器における不連続部の種々の実施形態を説明する断面図である。
【図７】本発明の他の実施例を説明する概略断面図である。
【図８】本発明の図７のゴム栓の説明する断面図である。
【図９】本発明の図８の注射器の筒ａ内に濃縮薬を製材する工程を説明するための概略断面図である。
【図１０】本発明において筒ａと筒ｂの結合部分に環状カバーを被せる場合を説明する部分断面図である。
【符号の説明】
１注射器、２本体、３本体、
４先端部、５ゴム栓、６キャップ
７合成樹脂製フィルム８第１密封栓、
９第２密封栓、１０第３密封栓、１１濃縮薬、
１２薬液、１３不連続部、１４ネジ窪、
１５ゴム栓、１６環状突起、１７鍔状突起、
１８凹窪、１９開口外周面壁、２０鉤爪状突起、
２１ノッチ、２２外周壁、２３原料混合薬液、
２４固定具又は棚、２５蒸気、２６打栓棒、
２７押棒、２８突起、２９両頭針、
３０環状の段３１針基、３２凹溝、
３３突起、３４不連続部、３５本体、
３６本体、３７ゴム栓、３８補助器具、
３９貫通孔、４０不連続部、４１フランジ、
４２突起、４３凹凸、４４ノッチ、
４５通路、４６内部室、４７突起、
４８突起、４９円筒体、５０針基、
５１針基先端部５２両頭針、５３両頭針後端、
５４キャップ、５５パッキン、５６環状カバー、
５７パッキン。[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a syringe having two interiors of syringe barrels. Specifically, each of the chambers can stably store a prescribed amount of medicine, and each chamber can be communicated with each other so that the medicine in one chamber can be stored. The present invention relates to an improvement of a syringe in which two chambers that can be administered as they are by mixing them by moving into the other chamber and being administered as a solution.
[0002]
[Prior art]
2. Description of the Related Art There is known a syringe that can also be used as a container in which medicines and drug solutions to be administered can be stored and stored in advance in a syringe barrel and can be quickly and hygienically administered in an emergency. As drugs using such syringes, unstable drugs, drugs with high titers and prescribed values, and mixed drugs were inappropriate.
Therefore, the inside of the cylinder is separated into two chambers by a sliding plug installed in the center of the inside of the syringe barrel, a thin injection groove is provided in the wall of the chamber on the tip side of the four syringe barrel, and the stopper is press-fitted with a push rod. Thus, a technique for mixing the chemicals in the two chambers by connecting the two chambers with the injection groove as a bypass has been developed. For example, Japanese Utility Model Publication No. 49-14465 is known, and further improved techniques are disclosed in Japanese Patent Laid-Open Nos. 58-61755, 62-5357, 62-14863, and 1-80371. JP-A-4-246364, JP-A-5-13977, JP-A-6-7446, JP-A-6-181985, JP-A-7-136267, JP-A-7-265423, JP-A-7-39582, Japanese Utility Model Publication Nos. 5-86535 and the like.
[0003]
On the other hand, in Japanese Patent Application Laid-Open No. 51-11691 and U.S. Pat. No. 4,031,892, the powder drug and the dissolving drug are housed in two separate containers, and both containers are connected adjacently, Both medicines are stored in a stable manner, and in use, the rubber plugs sealing the two containers are penetrated with a double-ended needle, and both chemicals are used using an opening provided in the middle of the double-ended needle. A technique for mixing and dissolving these has been proposed.
[0004]
In addition, in Japanese Utility Model Publication No. 5-152, a thin bypass groove is provided on the inner wall of a syringe consisting of a two-chamber container in which two cylindrical bodies are connected. A type of syringe has been proposed. For example, JP-A-6-142203, JP-A-7-136264, JP-A-7-136267, JP-A-7-148261, JP-A-7-299141 and the like are improved techniques of this type. The body is integrated and has a form that can maintain the quality of the medicine filled in each room. In any known technology, research efforts to make a syringe compatible with the ever-changing medical and pharmaceutical industries are expressed.
[0005]
[Problems to be solved by the invention]
The present invention aims at further improvement of the above-mentioned conventional technology, and can perform chemical filling and container binding operations easily and hygienically with a compact apparatus in the preparation process, and maintaining the quality of the chemical filled in each chamber. An object is to provide a syringe that combines two chambers having a structure that satisfies the requirements of improving the performance and arbitrarily selecting the degree of coupling of the containers.
[0006]
[Means for Solving the Problems]
The gist of the present invention is (1) to (9).
(1) Syringe needle part, substantially cylindrical, the tip is a mounting part of the needle part, and the rear end is sealed with a first sealing plug. It has a container b made of a synthetic resin whose rear end is sealed with a third sealing plug with a stopper, and a push rod. The container a is filled with solid medicine and the container b is filled with liquid medicine. The rear end of the container a and the front end of the container b are integrated in an airtight manner, and in use, the third sealing plug is pushed into the front end side by the push rod, and the first sealing plug, the second sealing plug, and the second sealing plug are used. 3. By moving the sealing plug to the distal end side, a flow path that connects the container a and the container b is formed, so that the medicine in the container b and the medicine in the container a can be mixed and dissolved to be administered. In the syringe having two chambers connected to each other, a tapered portion having an outer diameter decreasing toward the rear end on the outer peripheral surface in the vicinity of the rear end of the container a and the taper And a taper portion on the inner peripheral surface of the front end of the container b from the front end side toward the rear end, and a projection having a claw-like cross section having a shape corresponding to the hook-like projection following the tapered portion. A concave portion following the claw-like projection is provided, the rear end of the container a is fitted into the tip of the container b, and the tapered portion and the claw-like projection are engaged with the claw-like projection and the concave portion in cross section. By doing this, the container a and the container b Airtight The above-mentioned syringe characterized by being combined.
(2) The syringe according to (1), wherein the projection having a claw-like cross section of the container b has one or more notches cut from the distal end side of the container.
(3) Main body outer diameter D of the container a ₁ , Inner diameter d ₁ And the outer diameter D of the container b ₂ , Inner diameter d ₂ In D ₁ = D ₂ And d ₁ ≧ d ₂ The syringe according to (1) or (2), wherein
(4) Main body outer diameter D of the container a ₁ , Inner diameter d ₁ And the outer diameter D of the container b ₂ , Inner diameter d ₂ In D ₁ > D ₂ And d ₁ > D ₂ The syringe according to (1) or (2), wherein
(5) An annular cover is provided on the outer periphery of the joint part of the container a and the container b to cover the notch part and / or the step part of the outer periphery of the container a and the container b (1) or ( The syringe according to any one of 4).
(6) A cylindrical opening surface wall is formed between the rear end portion of the container a and the bowl-shaped protrusion, and the inner wall portion of the opening surface wall has a plurality of recesses in a cross section perpendicular to the cylinder axis. The syringe according to any one of claims 1 to (5) or 2 above.
(7) The tip of the container a has a tubular tip with an inner diameter smaller than that of the main body, and the inside of the main body and the inside of the tip are communicated with a passage having an inner diameter equal to or smaller than the inner diameter of the tip. The syringe according to any one of (1) to (6), which is characterized.
(8) The opening at the tip of the container a is hermetically sealed with an inverted U-shaped rubber stopper, and a cylindrical body is attached to the outer periphery of the tip, and the inside of the cylindrical body slides inside the cylinder. The syringe according to any one of claims 1 to 7, wherein a double-ended needle having a possible needle base is attached.
(9) The surfaces of the first sealing plug, the second sealing plug, the third sealing plug, and the inverted U-shaped rubber plug that are in contact with the drug are laminated with a synthetic resin film that is inert to the drug. The syringe according to any one of claims 1 to 8, wherein the syringe is characterized.
[0007]
BEST MODE FOR CARRYING OUT THE INVENTION
In the following, the structure of the present invention and the operation mechanism thereof will be described in detail. In this specification, of the two cylindrical containers, the injection needles are set to containers a and b from the side closer to the mounting portion, and each cylindrical container is also used. , The end near the injection needle is referred to as the front end, and the opposite end is referred to as the rear end.
The present invention relates to a container / syringe in which a container a and a container b filled with a medicine are sealed in a cylindrical body (chamber) in series, and the rear end of the container a and the front end of the container b are combined. The outer peripheral surface in the vicinity of the rear end is provided with a tapered portion whose outer diameter decreases toward the rear end and a hook-like projection following the taper portion, while the tapered portion and the hook-like projection are provided on the inner peripheral surface of the tip of the container b. A claw-like protrusion (hereinafter referred to as a claw-like protrusion) and a recess corresponding to the cross section, and by engaging the tapered part with the claw-like protrusion, and the claw-like protrusion and the recessed part, The first feature is that the claw-like projections are bitten into the recesses formed by the claw-like projections and securely engaged.
[0008]
FIG. 1 is a cross-sectional view showing one embodiment of the present invention. A cylindrical container a (hereinafter also abbreviated as “cylinder a”) having a tip portion 4 protruding in a tubular shape to which an injection needle is attached, and the container a A state in which a cylindrical container b (hereinafter also abbreviated as “cylinder b”) coupled to the end is coupled in series to form a syringe 1 that also serves as an integral container is shown. A solid drug (hereinafter collectively referred to as “concentrated drug”) 11 such as a concentrated drug, freeze-dried drug, powder drug, granule drug, tablet, crystal, and a mixed drug thereof is stored in the cylinder a, and a solution is stored in the cylinder b. Liquid medicines (hereinafter collectively referred to as “medical solutions”) 12 such as dispersions, physiological saline, and distilled water for injection are hermetically filled.
[0009]
The tube a has a main body 2 and a thin tubular tip 4 protruding from the main body 2. An inverted U-shaped rubber plug 5 is plugged into the opening of the tip 4 and sealed. A synthetic resin film 7 that is inert to the chemical is laminated on the surface of the rubber stopper 5 that is in contact with the chemical and the concentrated drug 11 to prevent contamination of the rubber material with the concentrated drug. Further, the opening of the rubber plug 5 is sealed with a cap 6 having a substantially H-shaped cross section, and the rubber plug 5 is fixed to the distal end portion 4. The rubber stopper 5 and the cap 6 are structured so that the injection needle can be attached as it is without being removed from the cylinder a. A first sealing plug 8 is disposed inside the rear end of the tube a. A space (chamber) formed between the rubber plug 5 and the first sealing plug 8 is filled with a concentrating drug 11, and the container is completely sealed by sealing with the rubber plug 5 and the first sealing plug 8. The airtightness of the concentrate 11 is maintained over a long period of time. The first sealing plug 8 is made of an elastic body and can seal the inside of the cylinder as described above and can slide inside the cylinder a.
[0010]
Further, the inner wall surface of the main body 2 of the cylinder a has a groove-like discontinuous portion that starts from a substantially central portion in the cylinder axis direction and extends to a position adjacent to the tip portion of the first sealing plug 8 along the cylinder axis direction. 13 is provided, and the length in the cylinder axial direction of the discontinuous portion 13 is greater than the total length in the cylinder axial direction of the first sealing plug 8 and the second sealing plug 9 disposed inside the cylinder b described later. It is enlarged.
[0011]
A second sealing plug 9 is tightly fitted inside the main body 3 of the cylinder b, and a third sealing plug 10 is tightly fitted inside the rear end. The second sealing plug 9 and the third sealing plug 10 are also made of an elastic material and have a sealing property, and are slidable in the cylinder b and the cylinder a. A chemical solution 12 is watertightly accommodated in a chamber formed between the second sealing plug 9 and the third sealing plug 10. Further, a screw recess 14 for engaging a push rod (not shown) is provided at the rear portion of the third sealing plug 10 inside the rear end of the tube b. As shown in the figure, an annular protrusion is provided on the inner wall at the rear end portion of the tube b, and the rubber plug 15 is plugged, so that the third sealing plug 10 can be stably disposed and the airtightness in the tube b is improved. It can be improved.
[0012]
The surfaces of the first sealing plug 8, the second sealing plug 9, and the third sealing plug 10 that are in contact with the concentrated drug 11 and the chemical solution 12 are also laminated with a synthetic resin film 7 that is inert to chemicals. To prevent chemical contamination.
[0013]
The first sealing plug 8, the second sealing plug 9 and the third sealing plug 10 are sufficiently considered in terms of materials and shapes so that the sliding performance in the cylinder a and the cylinder b can be secured as well as the sealing performance. It is desirable to select it. That is, there is no deformation in a wide temperature range from a high temperature such as autoclave sterilization to a low temperature of −50 ° C. at the time of freeze-drying, and there is no liquid leakage, and the interior can be hermetically sealed for a long time. The material and structure satisfy the requirement that the inside of the cylinder can be smoothly slid. The material will be described later. As for the structure, three or more ribs are provided on the surface of the first, second, and third sealing plugs 8, 9, and 10 in contact with the inner wall of the cylinder a or the cylinder b, The contradictory characteristics of sealing and sliding are compatible. Moreover, it is possible to achieve both sealing performance and sliding performance by using a ribless sealing plug having a synthetic resin film laminated on the surface. The material and structure of the rubber plug 5 are similarly taken into consideration.
[0014]
Next, the coupling of the cylinder a and the cylinder b, which is the first feature of the present invention, will be specifically described. FIG. 2 is a schematic diagram for explaining the structure in the vicinity of the coupling portion of the cylinder a and the cylinder b, and (a-1) in FIG. 2 is an axial cross-section of the end portion of the cylinder a. The part a-2) shows a view of the part (a-1) viewed from the direction of the arrow A, and the part (b-1) shows a section in the cylinder axial direction of the tip part of the cylinder b, and (b-2). ) Portion shows a view of the portion (b-1) as seen from the direction of arrow B. 3A is a perspective view of the tube a, FIG. 3B is a partially cutaway perspective view of the tube b, and FIG. 3C is a portion for explaining the connection between the tube a and the tube b. A cross-sectional view is shown.
[0015]
A tapered portion 16 is provided on the outer peripheral surface in the vicinity of the rear end of the tube a so that the outer diameter decreases toward the rear end. The outer diameter D of the main body 2 of the cylinder a at the minimum outer diameter portion of the tapered portion 16 ₁ Although the outer diameter is slightly smaller than the minimum outer diameter of the tapered portion 16, a hook-like protrusion 17 having an outer diameter is provided, and the rear end side from the hook-like protrusion 17 is smaller than the outer diameter of the hook-like protrusion 17. An opening surface wall 19 having a small outer diameter is formed. A recess is formed between the minimum outer diameter portion of the taper portion 16 and the hook-shaped protrusion 17 as shown in the (a-1) portion.
[0016]
On the inner peripheral surface of the distal end of the tube b, the protrusion is tapered from the end of the distal end so that the cross section thereof corresponds to the tapered portion 16, the hook-shaped protrusion 17, and the opening surface wall 19. A claw-like projection 20 and an outer peripheral wall 22 having a recess are provided. The tube a and the tube b are securely and firmly connected by engaging the hook-shaped protrusion 17 and the claw-shaped protrusion 20 so that the rear end portion of the tube a is fitted into the tip of the tube b. Can be integrated.
[0017]
In the embodiment shown in FIGS. 1 to 3, the opening surface wall 19 at the end of the cylinder a is convex, the tip of the cylinder b is concave, and the outer diameter D of the body 2 of the cylinder a ₁ , Inner diameter d ₁ And the outer diameter D of the body 3 of the cylinder b ₂ , Inner diameter d ₂ Were made equivalent.
By the way, increasing the thickness of the outer peripheral wall 22 following the claw-shaped projection 20 increases the strength of the tube b, but decreases the degree of freedom of slidability during the coupling operation. Therefore, it is preferable to provide a notch (thin notch) 21 in the claw-like projection 20 without increasing the thickness of the outer peripheral wall 22 by making the cylinder material high in strength. In this example, three notches 21 are provided.
[0018]
In this embodiment, the height of the claw-like projection 20 is 0.1 to 0.8 mm, and the length of the hook-like projection 17 in the direction perpendicular to the cylinder axis (projection length from the cylinder) is 0. Designed to be 1 to 0.8 mm, it realizes a strong coupling that makes it difficult to separate the cylinder a and the cylinder b.
As described above, according to the structure of the present invention, the height (cylinder axial direction length) of the hook-shaped protrusion 17 and the protruding length in the radial direction, the height and axial length of the hook-shaped protrusion, the material of the cylinder By selecting the strength, it is possible to freely select various bond strengths from a strong bond that is difficult to separate once engaged to a bond that can be separated relatively easily.
[0019]
In order to improve the sealing performance, it is further desirable to arrange an O-ring packing 55 between the cylinder a and the cylinder b as shown in FIG.
[0020]
Next, the structure of the inner peripheral surface of the container a end, which is the second feature of the present invention, will be described with reference to FIGS. In order to make the container very suitable for the preparation of the concentrated drug, as shown in FIGS. 2 and 3, a plurality of recesses 18 are cut out from the opening end surface of the opening surface wall 19 of the cylinder a to the inner wall surface of the rear end. . The depth of the recess 18 is preferably 5 to 12 mm, and the width is preferably 2 to 5 mm.
[0021]
The operation of the recess 18 will be described with reference to FIG. FIG. 4 is a partial cross-sectional view showing a state during the preparation process of the concentrated drug into the cylinder a. Although not shown, the tube a with the tip 4 sealed is fixed or placed on a fixture or a shelf 24 in a vacuum-concentrating chamber or a freeze-drying chamber (tank). The raw material mixed chemical solution 23 is charged into the cylinder a, and the end of the first sealing plug 8 is plugged to a position half the depth of the recess 18, that is, a half-plugged state, and held in a reduced-pressure atmosphere. To. At this time, in the illustrated example, the lower end of the second rib of the first sealing plug 8 is locked on the portion of the opening end surface of the opening surface wall 19 of the tube a where the concave portion 18 is not cut out. The vapor 25 such as a solvent from the raw material mixed chemical solution 23 is discharged through a passage formed between the recess 18 and the first sealing plug 8, and the raw material mixed chemical solution 23 is concentrated and dried to become a concentrated drug. . When the concentration and drying are completed, the first sealing plug 8 is completely plugged with the plug 26 or the like under reduced pressure. This makes it extremely easy to perform the concentration drying and plugging and sealing process in a sterilization chamber, which can greatly contribute to the improvement of the hygiene and operability of the preparation process.
[0022]
In addition, when the present invention is applied as a syringe / container for a medicine that does not require a vacuum concentration step or the like, the connecting portion between the cylinder a and the cylinder b, which is the first feature of the present invention, is simply set as described above. The recess 18 may not be provided. As a suitable example for applying such a syringe of the present invention, a combination of drugs in which a two-chamber type syringe / container is generally used, for example, a combination of drugs preferably mixed immediately before administration, Examples include a case where a synergistic effect is obtained by using a combination of multiple agents, such as a combination of an anticancer agent, an antibiotic, and an alkylating agent or a hormone agent.
[0023]
Preparation of the chemical solution into the cylinder b is performed according to a known technique. Briefly, first, the tube b, the second sealing plug, and the three sealing plug are washed and dried to remove fine particles, germs, and the like. After the second sealing plug 9 is plugged at the front end side of the cylinder b, a prescribed amount of purified and filtered chemical solution is filled, and then the third under vacuum so that no air (oxygen) or the like remains in the cylinder. The sealing plug 10 is plugged. Then, high-pressure steam sterilization is performed under conditions such as a steam temperature of 120 to 130 ° C. for 10 to 20 minutes.
[0024]
The cylinder a in which the concentrated drug obtained above is formulated is fixed, and the cylinder axis direction of the cylinder b in which the drug solution is formulated is arranged on an extension line in the cylinder axis direction of the cylinder a. By simply moving b toward the tube a in a linear direction, the hook-like protrusions of the tube a and the hook-and-mouth protrusions of the tube b can be engaged and firmly coupled, so that the tube a Integration of the cylinder b can be realized. Of course, the cylinder b may be fixed and the cylinder a may be moved toward the cylinder b. The conventional coupling structure requires a complicated process of combining using different instruments. Moreover, the structure which couple | bonds two cylindrical bodies by screwing requires the combination of the linear direction motion and rotational motion of a cylindrical body. In contrast, the coupling structure of the present invention is extremely easy because the assembly of the cylinder a and the cylinder b is only relative movement (one stroke) in the linear direction as described above, and this operation is performed in a clean room using a known apparatus. It can be operated unattended, and has the great advantage that the assembling apparatus can be inexpensive.
[0025]
Next, the usage method of the syringe of this invention is demonstrated. FIG. 5 is a schematic cross-sectional view showing a state in which the chemical solution 12 in the cylinder b is moved into the cylinder a and mixed with the concentrated drug 11. That is, by attaching a screw at the tip of the push rod 27 to the screw recess 14 of the third sealing plug 10 at the rear of the tube b and pushing the push rod 27 into the tube b, the pressure is transmitted through the chemical solution 12, and the first The two sealing plugs 9 move into the cylinder a substantially together with the first sealing plug 8, and the first sealing plug 8 and the second sealing plug 9 reach the discontinuous portion 13. The discontinuous portion 13 is a thin concave groove carved in the inner wall surface of the main body 2 of the cylinder a and extending in the cylinder axis direction, and the length thereof is the length of the first sealing plug 8 and the second sealing plug 9 in the cylinder axis direction. Since it is designed to be longer than the total, the first sealing plug 8 and the second sealing plug 9 fit into the discontinuous portion 13. On the other hand, since a projection 28 is provided on the inner wall surface of the cylinder opposite to the discontinuous portion 13, the tip of the first sealing plug 8 is temporarily locked by this projection 28. In addition, an annular step 30 is provided on the push rod to serve as a mark for stopping one end pushing at this temporary locking position. As a result, the air is completely moved to the tip of the cylinder a, and the discontinuous portion 13 forms a flow path communicating between the cylinder a and the cylinder b. The drug solution 12 in the cylinder b flows into the cylinder a through the flow path, dissolves the concentrated drug 11, and becomes an injection adjusted to a prescribed titer and concentration in the cylinder a. Next, with the rubber stopper 5 and the cap 6 attached to the distal end 4 of the cylinder a, the double-ended needle 29 is attached by the needle base 31 as shown in the figure, and the push rod is further pushed in, so that the air at the distal end in the cylinder a is reduced. After completely pushing out from the needle hole of the double-ended needle 29, the injection is administered by the same operation as that of the general-purpose syringe.
[0026]
6 is a cross-sectional view of various embodiments of the discontinuous portion 13 of the cylinder a of the syringe of the present invention. FIG. 6A is a cross-sectional view taken along the line aa ′ of FIG. Concentrated medicine 11 is stored in the interior of this chamber, and the discontinuous portion 13 is a concave groove 32 along the cylinder axis direction.
FIG. 5B is a cross-sectional view taken along line bb ′ of FIG. 5. The first sealing plug 8 and the second sealing plug 9 are located inside the main body 2 of the cylinder a, and the concave groove 32 of the discontinuous portion 13 is formed. The state which the chemical | medical solution 12 from the cylinder b is flowing as a channel | path is shown.
(C) is sectional drawing which shows another embodiment which forms the discontinuous part by the protrusion 33 and trough part of the cross-sectional triangle continuing on the wall inner surface of the pipe | tube a, and by contact | abutting to this protrusion 33, it is When the first sealing plug 8 and the second sealing plug 9 are deformed, the valley portion becomes a passage, and the chemical solution 12 can flow therethrough.
(D) is a sectional view showing another embodiment of the present invention in which a groove portion is formed as a discontinuous portion 34 by projecting into a thin mountain shape along the cylinder axis direction without changing the thickness of the outer peripheral wall of the tube a. It is.
(E) is sectional drawing which shows the other embodiment of this invention which provided the two discontinuous part 34 formed similarly to (d) in the symmetrical position, and made it the channel | path of the chemical | medical solution 12. FIG.
[0027]
FIG. 7 is a sectional view showing still another embodiment of the syringe of the present invention. In this embodiment, the outer diameter D of the body 35 of the cylinder a ₁ And the outer diameter D of the body 36 of the cylinder b ₂ But D ₁ > D ₂ There is a relationship that The cylinder a (35) is sealed at both ends with a rubber plug 37 and a first sealing plug 8, and the cylinder b (36) is a container sealed with a second sealing plug 9 and a third sealing plug 10. . Further, the rear end of the tube a (35) has a convex shape, and the front end of the tube b (36) is formed at the taper portion 16, the hook-like protrusion 17 and the boundary between them, as in the example of FIG. By fitting and engaging the claw-like projections (hereinafter referred to as claw-like projections) 20 and the outer peripheral wall 22 with the cross-section of the hollow portion and the cylinder b (36), the cylinder b (36) can be firmly and airtightly coupled only by simple linear movement. It is like that.
[0028]
The feature of the cylinder a (35) in FIG. 7 is that it has a structure suitable for formulating a subdivided concentrated drug. The concave portion 18 shown in FIG. 1 is not provided at the rear end of the tube a (35). In this embodiment, as shown in FIG. 8, a cap-shaped auxiliary device 39 having a hole in the center of the top surface is covered, and the first sealing plug 8 is fitted and locked in the top surface hole of the auxiliary device 39. To the concentration step. A through hole 39 is formed in the cylindrical side wall portion of the auxiliary device 39, and the vapor 25 from the raw material mixed chemical solution (not shown) is discharged from the through hole 38. Reference numeral 26 denotes a stopper rod.
[0029]
Each outer diameter D of the main body of the cylinder a (35) and the cylinder b (36) in FIG. ₁ , D ₂ And inner diameter d ₁ , D ₂ In D ₁ > D ₂ , D ₁ = D ₂ The outer diameter and wall thickness of the cylinder a (35) are designed to be large. The discontinuous portion of the tube a (35) forms a discontinuous portion 40 which is carved along the axial direction of the tube without changing the thickness of the tube wall. This is the part that becomes the flow path of the chemical solution. Further, by increasing the wall thickness of the cylinder a (35) in this manner, the effect of preventing the influence of environment, air, oxygen, humidity, and ultraviolet rays is improved.
[0030]
Although not shown in the figure, by increasing the inner diameter of the cylinder a to 101 to 104% of the inner diameter of the cylinder b, the second sealing plug 9 can be easily slidable. Furthermore, d ₁ = D ₂ And the inner diameter are almost the same, and the outer diameter is D ₁ > D ₂ Or D ₁ <D ₂ It can also be designed. By increasing the wall thickness of the main body of the tube b, it is easy to provide a groove on the outer peripheral surface and attach the finger-hanging flange 41 here, or to provide the surface with unevenness 43 with a wide width to prevent slipping. become. The flange 41 and the unevenness 43 on the surface serve as a finger rest for pressing the push rod 27 during drug administration, and the operation is ensured to prevent an erroneous needle stick.
[0031]
In the present invention, the sealing performance can be improved by disposing the ring-shaped packing 57 between the tube a (35) and the tube b (36). By the way, in the example in which the outer diameters of the cylinder a and the cylinder b are different as in the example of FIG. 7, a slight step is generated in the coupling portion as shown in FIG. In addition, since the tube b may be provided with a notch 44, by covering the stepped portion and the notch 44 from the outside with an annular cover 56, the connection between the tube a and the tube b is strengthened and the appearance is improved. An effect is obtained.
[0032]
In the distal end portion 4 of the syringe of the cylinder a (35) in FIG. ₁ After the inner diameter was narrowed to a very thin passage 45, it was expanded so as to form a wide inner chamber 43 again as shown in the inside of the tip portion protruding in a tubular shape. In the illustrated example, the narrow inner diameter portion is provided with a diameter of 0.05 to 0.42 mm and a length in the cylinder axis direction of 1 to 8 mm. The opening of the tip (inner chamber) is sealed with an inverted U-shaped rubber plug 37 whose sectional view is shown in FIG. 8, and an injection needle 52 with a cap 54 is attached.
[0033]
By narrowing the passage 45 at the tip of the cylinder a (35), the viscosity of the raw material mixed drug solution when the concentrated drug is formulated in the cylinder a (35) is adjusted to an appropriate value. Inflow of the raw material mixed chemical liquid into the passage 45 can be prevented. If it does in this way, it can prevent that an insoluble part generate | occur | produces at the time of mixing with the chemical | medical solution of this pipe | tube b. However, if the passage 45 is excessively narrow and long, the flow rate of the chemical solution due to the press-fitting of the push rod is reduced. Therefore, the raw material mixture chemical viscosity and the size of the passage 45 should be sufficiently examined and adjusted.
[0034]
As shown in FIG. 8, a synthetic resin film 7 that is inert to the chemical is laminated on the surface of the rubber plug 37 attached to the tip of the cylinder a (35) to prevent chemical contamination. To do. Further, an annular protrusion 47 is provided on the inner wall surface of the rubber plug 37 and an annular protrusion 48 is provided on the outer peripheral surface to improve the sealing performance and is particularly suitable for long-term storage of the concentrated drug 11 in the cylinder a. In addition to the form, the rubber stopper 37 was pierced with a double-ended needle and provided with a function as a guide when penetrating into the glass inner chamber 47. In addition, the rubber materials were commercialized after extensive investigation of known technologies.
[0035]
The tip of the tube a in FIG. 7 protrudes thinly, and a cylindrical body 49 is fixed to the protruding portion 53, and a double-ended needle 52 attached to the needle base 50 is accommodated in the cylindrical body 49. The needle base 50 can slide on the inner wall of the cylindrical body 49. When the drug solution in the syringe is administered to the human body, the needle cover 54 is removed, the tip 51 of the needle base 50 of the double-ended needle 52 is suppressed, and the inside of the cylindrical body 49 is pushed along the inner wall. The rear end of the double-ended needle 52 penetrates the bottom of the rubber plug 37 by being guided by the internal protrusion 47 of the rubber plug 37 and moves, and the rear needle tip 53 of the double-ended needle 52 has flowed out to the inner end 46. Reach the chemical. That is, the chemical liquid flows through the passage 45 and the inside 46 and flows out through the inside of the double-ended needle 52 by the pressure of the push rod. In the product according to the present invention, a double-ended needle is set in a part of a prepared syringe, and the needle tip of the double-ended needle is hygienically protected by a needle cover 54, so that it is not adversely affected by movement or transportation. .
[0036]
Since the syringe of the present invention has a structure in which the tube a and the tube b are completely separated in a state where the drug is stored as a container and moisture (humidity) does not affect the concentrated drug, the concentrated drug with high titer Can be stored stably for a long time. Also, in case of an emergency, the packaging is easily unpacked, and the medicine filled inside is mixed by press-fitting a push rod to adjust the chemical solution that has become a solution of the specified concentration and titer, and the set two heads Since it can be administered immediately from the needle, it can be administered with high hygiene without any operational error.
Furthermore, the syringe of the present invention can be applied to any syringe having a small volume of 0.2 ml to 1 ml to a large volume of 20 to 50 ml, and has a compact and suitable structure for carrying.
[0037]
In addition, when a commercially available adhesive or a cellophane tape, a synthetic resin-based tape or the like is employed as a conventional commercial product for the coupling means of the cylinder a and the cylinder b, low volatile components and harmful substances contained therein, Contamination from impurities and the like is a concern, but there is no such danger in the present invention.
[0038]
The material constituting the syringe and container body of the present invention is a synthetic resin in consideration of moldability. And Moreover, what does not contaminate a chemical | medical agent is preferable. For example, it is preferable to use one or more of a resin containing a cyclic olefin compound or a crosslinked polycyclic hydrocarbon compound as a polymerization component, polyethylene, polypropylene, polycarbonate, polymethylpentene, polyester resin and the like. It is also preferable to laminate two or more synthetic resin materials. In this case, it is preferable to use the above-mentioned synthetic resin free from chemical contamination on the surface in contact with the medicine and use a synthetic resin having slightly different characteristics as the layer not in contact with the medicine. Examples of the latter synthetic resin include polysulfone, polyarylate, modified phenylene oxide resin, polyamide, polyvinyl alcohol, and polyvinyl acetate. A mixture or alloyed product of the former resin and the latter resin can be recommended as a particularly preferred resin. Silicone oxide, aluminum oxide, magnesium oxide, etc. deposited on the surface of a synthetic resin have a barrier action against oxygen, air, and moisture (humidity), so that the quality of the medicine filled in the syringe is maintained and stored for a long time. Is preferred.
[0039]
The syringe of the present invention can be adapted to a wide size range from a small capacity of 0.2 to 1 ml to a large capacity of about 50 ml, and also has a high hygroscopic and easily oxidative instability and medicines housed in a large capacity cylinder. The aim was to achieve long-term storage for 3 to 5 years. For this purpose, the first, second, and third sealing plugs of the present invention are required to have both high sealing plugs and slidability. As the material, known materials used in this kind of field can be used. The physical properties of the material are, for example, a relatively soft material with a JIS hardness of about 30 and a heat-resistant elastic rubber body having no compression strain, for example, a rubber elasticity of about 10% compression strain at 100 ° C. The body is preferred. For example, preferred are isobutylene-isoprene copolymer rubber (IIR), IIR chlorinated rubber, IIR brominated rubber, isobutylene-isoprene-divinylbenzene terpolymer rubber, and the like.
Examples of the material of the synthetic resin film laminated to prevent chemical contamination by the rubber material include, for example, tetrafluoroethylene resin, trifluoroethylene chloride resin, tetrafluoroethylene-hexafluoropropylene copolymer resin, and fluorine. And vinylidene chloride resin, vinyl fluoride resin, ethylene tetrafluoride-ethylene copolymer resin, ethylene trifluoride-ethylene copolymer resin, and the like.
Further, the shape of the sealing plug is preferably one in which three or more annular ribs are provided at the sliding portion with the inner wall of the cylinder. In addition, it is desirable to apply a known technique in this kind of field to the highest degree. In addition, it is preferable to use the same rubber elastic body and synthetic resin film laminate as in the case of the sealed stopper for the inverted U-shaped rubber stopper.
[0040]
【The invention's effect】
As described above, the present invention is a syringe in which a medicine is stored in two cylindrical containers, and a hook-shaped part and a tapered part at the rear end of the container a and a protrusion having a claw-like cross section at the tip of the container b By having a structure that is connected in series at the section,
1) In the formulation process, the two cylindrical containers can be simply and securely combined firmly by moving them linearly;
2) Since the coupling method of 1) above is simple, it is easy to carry out even under complicated environmental conditions such as in a clean room and a sterilization room, and the apparatus and operation are not expensive, and the economic effect is great.
3) Since two kinds of chemicals can be formulated separately in each container and then combined, the stability of the chemicals and the formulation process can be simplified, which is extremely safe, hygienic and economical. To be advantageous,
4) Since the container can be configured to be airtight and a thick wall structure can also be adopted, it has a high level of water absorption resistance and airtightness, making it particularly suitable for holding concentrated concentrates that are unstable and have titer regulation. thing,
5) In two cylindrical containers, the chemical solution to be administered can be mixed and adjusted hygienically and quickly, and can be used immediately.
6) Since the coupling part is compact and the entire syringe can be configured compactly, it is also suitable for portable use.
There is an effect.
[Brief description of the drawings]
FIG. 1 is a schematic cross-sectional view illustrating an embodiment of the present invention.
FIG. 2 is a view for explaining a structure of a coupling portion between a cylinder a and a cylinder b in FIG. 1;
FIG. 3 is a view for explaining the structure of a connecting portion between a cylinder a and a cylinder b in FIG. 1;
4 is a schematic cross-sectional view for explaining a step of formulating a concentrated drug in the tube a of FIG.
FIG. 5 is a schematic cross-sectional view for explaining a state in which the chemical solution in the cylinder b of FIG. 1 is transferred into the cylinder a.
FIG. 6 is a cross-sectional view illustrating various embodiments of discontinuities in the syringe of the present invention.
FIG. 7 is a schematic sectional view for explaining another embodiment of the present invention.
FIG. 8 is a cross-sectional view illustrating the rubber plug of FIG. 7 according to the present invention.
9 is a schematic cross-sectional view for explaining a step of lumbering a concentrated drug in the cylinder a of the syringe of FIG. 8 according to the present invention.
FIG. 10 is a partial cross-sectional view for explaining a case where an annular cover is put on a joint portion between a tube a and a tube b in the present invention.
[Explanation of symbols]
1 syringe, 2 body, 3 body,
4 Tip, 5 Rubber stopper, 6 Cap
7 Synthetic resin film 8 First sealing plug,
9 Second sealing plug, 10 Third sealing plug, 11 Concentrated drug,
12 chemicals, 13 discontinuities, 14 screw recesses,
15 rubber stopper, 16 annular protrusion, 17 hook-shaped protrusion,
18 depression, 19 opening outer peripheral surface wall, 20 claw-like projection,
21 notch, 22 outer peripheral wall, 23 raw material mixed chemical,
24 fixtures or shelves, 25 steam, 26 stoppering rods,
27 push rods, 28 protrusions, 29 double-ended needles,
30 annular step 31 needle base, 32 groove,
33 protrusions, 34 discontinuities, 35 body,
36 body, 37 rubber stopper, 38 auxiliary equipment,
39 through holes, 40 discontinuities, 41 flanges,
42 protrusions, 43 irregularities, 44 notches,
45 passages, 46 internal chambers, 47 protrusions,
48 protrusions, 49 cylinders, 50 needle bases,
51 Needle base tip 52 Double-ended needle, 53 Double-ended needle rear end,
54 cap, 55 packing, 56 annular cover,
57 Packing.

Claims

The injection needle portion is substantially cylindrical and the tip is an attachment portion of the injection needle portion and the rear end is sealed with a first sealing plug. The container a is substantially cylindrical and the tip is back with a second sealing plug. A container b made of a synthetic resin, each of which is sealed with a third sealing plug, and a push rod, the container a is filled with a solid medicine and the container b is filled with a liquid medicine; The rear end of a and the front end of the container b are integrated in an airtight manner, and when used, the third sealing plug is pushed into the front end side by the push rod, and the first sealing plug, the second sealing plug, and the third sealing plug 2 chambers to form a flow path that connects the container a and the container b by moving the container to the distal end side, so that the medicine in the container b and the medicine in the container a can be mixed and dissolved for administration. In the syringe coupled with the taper portion, the outer diameter of the container a near the rear end of the container a decreases toward the rear end and the outer diameter of the cylinder decreases. A hook-shaped protrusion is provided, and the inner peripheral surface of the tip of the container b has a tapered hook-shaped protrusion and a hook-shaped nail having a shape corresponding to the tapered protrusion following the tapered portion from the front end side to the rear end. A recess that follows the protrusion, and the rear end of the container a is fitted into the front end of the container b, and the tapered portion and the hook-like protrusion engage the hook-like protrusion and the recess. The above-described syringe, wherein the container a and the container b are hermetically coupled by the above.

2. The syringe according to claim 1, wherein the projection having a claw-like cross section of the container b has one or more notches cut from the distal end side of the container.

The main body outer diameter D ₁ and inner diameter d ₁ of the container a and the main body outer diameter D ₂ and inner diameter d ₂ of the container b satisfy D ₁ = D ₂ and d ₁ ≧ d ₂ , respectively. The syringe according to claim 1 or 2.

The main body outer diameter D ₁ and inner diameter d ₁ of the container a and the main body outer diameter D ₂ and inner diameter d ₂ of the container b satisfy D ₁ > D ₂ and d ₁ > d ₂ , respectively. The syringe according to claim 1 or 2.

The annular cover is provided on the outer periphery of the joint part of the container a and the container b to cover the notch part and / or the step part of the outer periphery of the container a and the container b. The syringe according to any one of the above.

A cylindrical opening surface wall is formed between the rear end portion of the container a and the hook-shaped protrusion, and the inner wall portion of the opening surface wall has a plurality of recesses in a cross section perpendicular to the cylinder axis. The syringe according to any one of claims 1 to 5 or 2 above.

The tip of the container a is characterized in that a tubular tip having an inner diameter smaller than that of the main body protrudes, and the inside of the main body and the inside of the tip are communicated with a passage having an inner diameter equal to or smaller than the inner diameter of the tip. The syringe according to any one of claims 1 to 6.

The opening at the tip of the container a is hermetically sealed with an inverted U-shaped rubber stopper, a cylinder is attached to the outer periphery of the tip, and a needle that can slide inside the cylinder is inserted into the cylinder The syringe according to any one of claims 1 to 7, wherein a double-ended needle having a base is attached.

The surfaces of the first sealing plug, the second sealing plug, the third sealing plug, and the inverted U-shaped rubber plug that are in contact with the drug are laminated with a synthetic resin film that is inert to the drug. The syringe according to any one of claims 1 to 8.