JP2004275471A

JP2004275471A - Medical valve

Info

Publication number: JP2004275471A
Application number: JP2003071259A
Authority: JP
Inventors: Norihiro Hiejima; 徳寛比恵島; Masaru Suzuki; 賢鈴木; Kazuyoshi Harada; 和良原田
Original assignee: Nipro Corp
Current assignee: Nipro Corp
Priority date: 2003-03-17
Filing date: 2003-03-17
Publication date: 2004-10-07

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical valve capable of being connected to a male lure 37 nearly in the sterilized condition. <P>SOLUTION: The medical valve comprises a housing 1 opening at the upper end into which the tip 38 of the male lure 37 is inserted, a spike body 2 opening at the upper end, whose lower part is connected to a fluid circuit 26, an elastically deformable and tube-shaped elastic seal 3 to be fitted to the spike body 2 from outside, whose upper part is an open/close part 28 to open/close the upper end opening of the spike body 2, having an engagement part 31 formed in the middle in the vertical direction to project outward in the radial direction from the upper side, a releasing member 4 fitted to a part on the upper side from the engagement part 31 in the elastic seal 3 from outside to be movable in the vertical direction for releasing the open/close part 28 of the elastic seal 3 by contracting the elastic seal 3 downward via the engagement part 31 as pressed by the tip 38 of the male lure 37 downward, and an energizing means 5 for energizing the releasing member 4 upward to abut to the inner surface of the housing 1 to be located at a prescribed position. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

【０００１】
【発明の属する技術分野】
本発明は医療用弁に関し、液体回路、例えば、輸液バッグ、輸液ライン（ルート）の中途部、体外液体回路に備えられて、微量元素、ビタミン、抗生物質等の薬液の補液、混注、追加投与等を行うための混注プラグ等において、操作者の誤穿刺等の問題から、金属針を用いずに、雄ルアーの接続により補液等を行えるものに関する。
【０００２】
【従来の技術】
金属針を用いずに、輸液ルートにシリンジや他の液体回路等の雄ルアーを接続する医療用弁として、ハウジングに内蔵された針状のスパイク体が、弾性シールにより被覆されたものがある（例えば、特許文献１参照。）。
【０００３】
このものでは、雄ルアーのチップの押圧により、弾性シールが下方に圧縮され、スパイク体が弾性シールに挿通されて、上方に露出し、雄ルアーのチップ内に進入する。これにより、雄ルアー内部とスパイク体内部の液体移送路が、スパイク体の側面の開口を介して、連通し、液体が移送可能となる。又、雄ルアーのチップによる弾性シールの押圧を解除すると、圧縮状態の弾性シールが、その弾発力により、伸長して、元の大きさに戻り、スパイク体は弾性シール内にシールされる。
【０００４】
上記のものでは、スパイク体が、外気に触れない雄ルアーのチップ内部に進入して、雄ルアー内部とスパイク体内部の液体移送路が連通するため、一見、雄ルアーと医療用弁を略無菌状態で（無菌的に）接続できるように考えられる。
【０００５】
【特許文献１】
特表平７―５０５０６４号公報
【０００６】
【発明が解決しようとする課題】
然しながら、実際には、万が一、雄ルアーのチップ下端に雑菌が付着していた場合には、雄ルアーのチップ下端により弾性シールを押圧した際に、弾性シールの上端面に雑菌が付着する惧れがあった。又、上記のように、雄ルアーのチップ下端により、弾性シールを押圧して、スパイク体を雄ルアーのチップ内部に導入した際には、雄ルアーのチップ先端がスパイク体外面に触れて、スパイク体外面に雑菌が付着する惧れもあった。
【０００７】
上記のように、スパイク体外面や弾性シールの上端面に雑菌が付着すると、雄ルアーとスパイク体間で移送する液体が、付着した雑菌で汚染される惧れがあり、雄ルアーと医療用弁を略無菌状態で接続できない惧れがあったのが実情である。
【０００８】
本発明はこのような従来の問題点を鑑みてなされたもので、雄ルアーと略無菌状態で接続可能な医療用弁を提供することを目的とする。
【０００９】
【課題を解決するための手段】
上記目的を達成するために、本発明の特徴とするところは、雄ルアーが分離可能に接続される医療用弁であって、Ａ．上端が開口する中空とされて、雄ルアーのチップが挿脱自在に挿入されるハウジングと、Ｂ．上端で開口するパイプ状とされ、ハウジング内に上下方向に配設されて、下部が流体回路に接続されるスパイク体と、Ｃ．弾性変形可能なチューブ状とされて、スパイク体に外嵌されると共に、上部が、スパイク体の上方に位置してスパイク体の上端開口を開閉可能に閉鎖する開閉部とされ、上下方向中途部に、その上方側よりも径方向外方に突出する係合部が形成された弾性シールと、Ｄ．弾性シールにおける、係合部よりも上方側部分に、上下方向に移動自在に外嵌され、雄ルアーのチップにより下方に押圧されて、弾性シールの係合部と当接し、弾性シールを、弾性変形により、下方に縮小させると共に、スパイク体の上端により、弾性シールの開閉部を径方向外方に弾性変形させて、開放させ、開閉部をスパイク体に外嵌させて、開閉部により、スパイク体外面と雄ルアーのチップ内面間をシールさせる開放部材と、Ｅ．開放部材を上方に付勢し、ハウジング内面と当接させて、所定位置とする付勢手段を有する点にある。
尚、ハウジング、弾性シール及び開放部材の３者の上端面が略面一とされることもある。
又、ハウジングが、・その下部に位置し、スパイク体の下部が接続されて、スパイク体の下端開口と連通すると共に、液体回路と接続される接続体を有し、接続体と開放部材間に付勢手段が介装されることもある。
更に、開閉部に、径方向のスリットが上下方向に貫通形成されることもある。又、弾性シールが、開閉部と係合部の他に、Ａ．開閉部の下方に連設され、開閉部と略同一外径を有する小径部と、Ｂ．小径部の下方に連設され、小径部よりも大径とされた大径部を有し、係合部が、小径部と大径部の境界部に段付状に形成されて、上方に面状を呈することもある。
更に、開放部材が、Ａ．開放部材の上部を構成し、弾性シールの開閉部及び小径部に上下方向に移動自在に外嵌されて、係合部を押圧する押圧部と、Ｂ．押圧部の下方に連設され、押圧部よりも内径が大とされて、弾性シールの小径部、係合部及び大径部に上下方向に移動自在に外嵌された中間部と、Ｃ．中間部の下方に連設され、中間部よりも外径が大とされて、弾性シールの大径部に上下方向に移動自在に外嵌され、付勢手段により、上方に付勢される大径部を有することもある。
又、ハウジングの内部が、Ａ．上記内部の上部を構成し、その内部に、弾性シールの開閉部と小径部及び、開放部材の押圧部及び中間部が位置する小径孔と、Ｂ．小径孔の下方に連設され、その内部に、弾性シールの大径部及び開放部材の大径部が位置する大径孔と、Ｃ．小径孔と大径孔の境界部に段付状に形成されて、下方に面状を呈し、付勢手段による付勢により、開放部材の大径部が当接するストッパ部を有することもある。
【００１０】
【発明の実施の形態】
以下、本発明を混注プラグに適用した実施の形態の一例を図面に基づき説明すると、混注プラグは、ハウジング１と、スパイク体（パイプ）２と、弾性シール（部材）３と、開放部材（可動キャップ）４と、圧縮コイルバネ５等を有する。
【００１１】
ハウジング１は、上下両端で開口する中空とされて、雄ルアーが挿脱自在に挿入されるもので、本体７と、接続体８を有する。本体７及び接続体８の構成材料としては、ポリカーボネート樹脂、アクリル樹脂、硬質塩化ビニル樹脂、高密度ポリエチレン樹脂、ポリプロピレン樹脂、アクリルニトリル・ブタジエン・スチレンブロック共重合体樹脂、ポリアミド樹脂、ポリエチレンテレフタレート樹脂、ポリブチレンテレフタレート樹脂、ポリアセタール樹脂、フッ素樹脂、ポリフェニレンサルファイド樹脂、ポリエーテルサルフォン樹脂、ポリエーテルエーテルケトン樹脂、液晶ポリマー樹脂等が挙げられる。又、上記樹脂に、ガラス繊維、グラファイト、無機フィラー、カーボンナノチューブ等を配合して、強度を強化したものを用いても良い。
【００１２】
本体７は、上下両端で開口する中空とされて、上部が、雄ルアーが分離可能に接続される上流側（雄）連結部（（雄）継手手段、（雄）継手部）１０とされ、外周面に雄螺子部１１が形成されている。本体７の内面には、上流側連結部１０の内面とされる小径孔１２と、小径孔１２よりも大径とされた大径孔１３と、大径孔１３よりも大径とされ且つ雌螺子が形成された雌螺子部１４が、上記の順で、下方に連設されている。小径孔１２と大径孔１３の境界部には、段付状とされ且つ下方に面状を呈するストッパ部１５が形成されている。
【００１３】
接続体８は、上下両端で開口する中空状とされて、本体７の下部内に挿入、固着されている。接続体８は、接続部１８と、接続部１８よりも大径とされ且つ外周面に雄螺子が形成された嵌合部１９と、嵌合部１９よりも小径とされた下流側（雄）連結部（（雄）継手手段、（雄）継手部）２０を、上記の順で、下方に連設することで、一体形成されている。接続体８内面には、接続部１８及び嵌合部１９の上端部の内部に形成された挿入孔２１と、嵌合部１９の残部及び下流側連結部２０の内部に形成され且つ挿入孔２１よりも大径とされた連通孔２２が配設されている。尚、接続体８に嵌合部１９を設けず、接続体８を本体７と接着してもよい。
【００１４】
接続部１８は、弾性シール３の下部が外嵌、接続されるもので、本体７の大径孔１３よりも小径とされて、大径孔１３の下部内に位置している。接続部１８は、上部が、円錐台形状の抜止部２４とされて、下部よりも径方向外方に突出し、弾性シール３の内面に食い込んで、弾性シール３の接続部１８からの不慮の脱落を防止する。
【００１５】
嵌合部１９は、本体７の雌螺子部１４内に挿入、螺結されて、固定されている。
【００１６】
下流側連結部２０は、本体７の雌螺子部１４の下部内から下方に突出すると共に、下方に向かって、テーパー状とされており、液体回路として例示される液体移送用チューブ２６が分離可能に接続されている。尚、液体回路は、輸液ラインや体外液体回路のチューブだけでなく、輸液バッグ等の各種液体バッグや各種機器も含む。
【００１７】
スパイク体２は、上下両端で開口するパイプ状とされて、ハウジング１内に上下方向に配設されると共に、下端開口がチューブ２６と連通するもので、下部が、接続体８の挿入孔２１内に挿着され、下部を除く部分が、本体７の小径孔１２及び大径孔１３内に配設されて、上端が、本体７の上端よりも、若干、低くされている。スパイク体２の構成材料としては、ステンレス、各種樹脂等が挙げられる。
【００１８】
弾性シール３は、弾性変形可能なチューブ状（略円筒状）とされて、スパイク体２に上方から外嵌されるもので、円盤（円柱）の開閉部２８と、開閉部２８よりも内径が大とされ且つ開閉部２８と同一外径を有するチューブ状の小径部２９と、小径部２９よりも内径及び外径が大とされた大径部３０を、上記の順で、下方に連設することで、一体形成されている。弾性シール３の構成材料としては、天然ゴム、合成ポリイソプレンゴム、ブチルゴム、クロロプレンゴム、シリコーンゴム、ウレタンゴム、スチレンーブタジエンゴム、エチレンプロピレンゴム、アクリルゴム、フッ素ゴム、熱可塑性エラストマー等が挙げられる。
【００１９】
開閉部２８は、本体７の小径孔１２の上部内に配設されて、スパイク体２の上方に位置しており、その上端面が本体７の上端面と（略）面一とされる共に、下端面がスパイク体２の上端面と当接、又は、若干、間隙を介して、対向している。開閉部２８の外径は、雄ルアーの内径と（略）同一、又は、上記内径よりも若干小とされている。又、開閉部２８の外周部を除く部分には、単一（又は、直交する２本の）径方向のスリット３２が、上下方向に貫通形成されており、開閉部２８の径方向外方への弾性変形により、スリット３２が開放可能とされている。
【００２０】
小径部２９は、本体７の小径孔１２の上下方向中途部に位置して、その内径がスパイク体２の外径と（略）同一、又は、該外径よりも、若干、大とされており、小径部２９と大径部３０の境界部分には、小径部２９よりも径方向外方に突出し且つ上方に面状を呈する係合部３１が形成されている。
【００２１】
大径部３０は、本体７の小径孔１２の下端部及び大径孔１３の内部に位置しており、その下部は、接続部１８に外嵌、固着されて、抜止部２４により、抜止めされている。
【００２２】
開放部材４は、雄ルアーの接続時に、弾性シール３を下方に押圧するもので、略円筒状とされ、弾性シール３の上部に外嵌されて、弾性シール３と本体７間に位置し、弾性シール３及び本体７に対して、上下方向に移動（摺動）自在とされている。開放部材４は、上部の押圧部３３と、押圧部３３よりも内径が大とされ且つ押圧部３３と（略）同一外径を有する中間部３４と、中間部３４と（略）同一内径を有し且つ中間部３４よりも外径が大とされた大径部３５を、上記の順で、下方に連設することで、一体形成されている。開放部材４は、上記のように、弾性シール３を押し下げる機能を有するため、軟質でない材料が好ましい。尚、弾性シール３周辺の無菌性を向上するために、開放部材４に、抗菌剤（銀・亜鉛置換ゼオライト、銀担持リン酸カルシウム等）を練り込んでも良い。又、開放部材４に弾性を付与する場合もある。
【００２３】
押圧部３３は、弾性シール３の開閉部２８及び小径部２９に外嵌されて、本体７の小径孔１２内に位置し、その内径が、弾性シール３の開閉部２８の外径と（略）同一、又は、該外径よりも、若干、大とされると共に、その外径が、本体７の小径孔１２の内径と（略）同一、又は、該内径よりも、若干、小とされている。そして、雄ルアーによる押圧部３３の下方への押圧時に、弾性シール３の係合部３１と当接して、弾性シール３を、弾性変形により、下方に縮小させ、この縮小及び弾性シール３の開閉部２８とスパイク体２の上端との当接により、開閉部２８が径方向外方に弾性変形して、開閉部２８のスリット３２が開放され、開閉部２８が開放されて、スパイク体２の上端開口が開放されると共に、開閉部２８がスパイク体２に外嵌されて、開閉部２８により、スパイク体２外面と雄ルアーのチップ内面間がシールされる。
【００２４】
中間部３４は、弾性シール３の小径部２９及び大径部３０に外嵌されて、本体７の小径孔１２及び大径孔１３の上部の内部に位置し、その内径は、弾性シール３の大径部３０の外径よりも、若干、大とされている。
【００２５】
大径部３５は、弾性シール３の大径部３０に外嵌されて、本体７の大径孔１３上部内に位置し、その外径は、本体７の大径部の内径と（略）同一、又は、該内径よりも、若干、小とされると共に、ストッパ部１５と対向している。
【００２６】
圧縮コイルバネ５は、付勢手段として例示されるもので、接続体８の嵌合部１９の上面と開放部材４の大径部３５間に弾発状に介装されて、開放部材４を上方に付勢し、開放部材４の大径部３５を本体７のストッパ部１５と当接させることで、開放部材を所定位置（待機位置、非接続位置）として、その上端面を、本体７及び弾性シール３の両者の上端面と（略）面一とさせている。尚、バネ５の構成材料としては、金属、樹脂等が挙げられるが、弾性回復力（弾性復元力、弾発力）が大である金属が好ましい。又、付勢手段を、ゴムチューブとすることもあり、この際には、ゴムチューブを、開放部材４と別体とする場合と、一体化する場合とがある。
【００２７】
上記構成例では、混注プラグを介して、輸液、採血等を行なう場合には、混注プラグの上端面を消毒した後、例えば、図２に示すように、雄ルアーとして例示されるシリンジ３７のチップ３８を、ハウジング１の本体７の小径孔１２内に上端開口から挿入する。
【００２８】
この際、図３の仮想線で示すように、シリンジ３７として、内面に雌螺子部が形成されたロック部材４０付きのものを使用し、このロック部材４０の雌螺子部を本体７の雄螺子部１１に螺結すれば、シリンジ３７の上記挿入状態を確実に維持できる。
【００２９】
シリンジ３７のチップ３８の上記挿入により、開放部材４が下方に押圧されて、開放部材４が、バネ５の弾発力に抗して、押し下げられる。これにより、開放部材４の押圧部３３が弾性シール３の係合部３１に当接し、弾性シール３を、下方に弾性変形させながら、縮小させる。
【００３０】
この縮小及び弾性シール３の開閉部２８とスパイク体２の上端との当接により、図３に示すように、開閉部２８が径方向外方に弾性変形して、開閉部２８のスリット３２が開放され、開閉部２８が開放されて、スパイク体２の上端開口が開放されると共に、開閉部２８がスパイク体２に外嵌されて、開閉部２８により、スパイク体２の外面とシリンジ３７のチップ３８の下部の内面間がシールされる。
【００３１】
これにより、スパイク体２外面とシリンジ３７のチップ３８の下部内面間がシールされた状態で、シリンジ３７内部が、スパイク体２、接続体８の連通孔２２を介して、チューブ２６と連通するので、輸液、採血等を従来同様に行なえる。
【００３２】
輸液、採血等が終了すれば、シリンジ３７のチップ３８をハウジング１の本体７内から抜去する。これによって、バネ５の弾発力により、開放部材４が上昇して、その大径部３５が本体７のストッパ部１５と当接すると共に、弾性シール３の大径部３０が、その弾発力により、上方に伸長して、元の大きさに戻る。これと同時に、小径部２９及び開閉部２８も上昇して、元の位置に戻り、これにより、開閉部２８のスリット３２が閉鎖されて、開閉部２８が閉鎖され、スパイク体２の上端開口が閉鎖される。
【００３３】
上記構成例によれば、シリンジ３７のチップ３８の下端により、弾性シール３ではなく、その径方向外方に位置する開放部材４を押圧するので、シリンジ３７のチップ３８の下端が、弾性シール３の上端面やスパイク体２と接触することを防止できる。それ故、万が一、シリンジ３７のチップ３８の下端に雑菌が付着していた場合でも、雑菌は開放部材４の上端面に付着する惧れがあるだけで、雑菌が弾性シール３の上端面やスパイク体２に付着することを防止できる。
【００３４】
そして、シリンジ３７のチップ３８の下端や開放部材４の上端面に雑菌が付着していても、シリンジ３７による開放部材４の押圧時に、弾性シール３の開閉部２８により、スパイク体２外面とシリンジ３７のチップ３８の下部内面間がシールされるので、シリンジ３７とスパイク体２間で移送する液体が、雑菌により、汚染される惧れがない。即ち、上記構成例によれば、シリンジ３７と混注プラグを略無菌状態で（無菌的に）接続できる。
【００３５】
尚、実施の形態は、本発明を混注プラグに適用したものであるが、本発明は、その他の各種医療用弁に適用可能である。
【００３６】
【発明の効果】
以上詳述したように、本発明によれば、雄ルアーと医療用弁を略無菌状態で接続できる。
【図面の簡単な説明】
【図１】本発明の実施の形態の一例を示す断面図である。
【図２】図１の作動状態図である。
【図３】図２の作動状態図である。
【符号の説明】
１ハウジング
２スパイク体
３弾性シール
４開放部材
５圧縮コイルバネ（付勢手段）
７本体
８接続体
１２小径孔
１３大径孔
１５ストッパ部
２６液体移送用チューブ（液体回路）
２８開閉部
２９小径部
３０大径部
３２スリット
３１係合部
３３押圧部
３４中間部
３５大径部
３７シリンジ
３８チップ[0001]
TECHNICAL FIELD OF THE INVENTION
TECHNICAL FIELD The present invention relates to a medical valve, which is provided in a liquid circuit, for example, an infusion bag, a middle part of an infusion line (route), an extracorporeal liquid circuit, and replaces, co-injects, and additionally administers a chemical solution such as trace elements, vitamins, and antibiotics. The present invention relates to a co-injection plug or the like for performing fluid replacement or the like by connecting a male luer without using a metal needle due to a problem such as erroneous puncture of an operator.
[0002]
[Prior art]
As a medical valve for connecting a male luer such as a syringe or another liquid circuit to an infusion route without using a metal needle, there is a medical valve in which a needle-like spike body built in a housing is covered with an elastic seal ( For example, see Patent Document 1.)
[0003]
In this device, when the tip of the male luer is pressed, the elastic seal is compressed downward, and the spike body is inserted through the elastic seal, exposed upward, and enters the male luer tip. As a result, the liquid transfer paths inside the male luer and the spike body communicate with each other through the opening on the side surface of the spike body, and the liquid can be transferred. When the pressing of the elastic seal by the tip of the male luer is released, the elastic seal in a compressed state expands and returns to its original size due to its elastic force, and the spike body is sealed in the elastic seal.
[0004]
In the above, the spike body enters the inside of the tip of the male lure that does not come into contact with the outside air, and the inside of the male luer and the liquid transfer path inside the spike body communicate with each other. It is conceivable to be able to connect aseptically (aseptically).
[0005]
[Patent Document 1]
Japanese Patent Publication No. 7-505064
[Problems to be solved by the invention]
However, in reality, if germs adhere to the lower end of the male luer tip, the germs may adhere to the upper end surface of the elastic seal when the elastic seal is pressed by the lower end of the male luer tip. was there. Also, as described above, when the elastic seal is pressed by the lower end of the male luer tip and the spike body is introduced inside the male luer tip, the tip end of the male luer touches the outer surface of the spike body, There was also a fear that various bacteria would adhere to the external surface.
[0007]
As described above, if germs adhere to the outer surface of the spike body or the upper end surface of the elastic seal, the liquid transferred between the male luer and the spike body may be contaminated by the attached germs. The fact is that there was a fear that the connection could not be established under almost aseptic conditions.
[0008]
The present invention has been made in view of such conventional problems, and has as its object to provide a medical valve that can be connected to a male luer in a substantially aseptic condition.
[0009]
[Means for Solving the Problems]
In order to achieve the above object, a feature of the present invention is a medical valve to which a male luer is detachably connected. B. a housing having a hollow upper end and into which a male luer tip is removably inserted; B. a spike body having a pipe shape opened at an upper end, disposed vertically in the housing, and having a lower part connected to a fluid circuit; An elastically deformable tubular shape, which is fitted over the spike body, and an upper part is an opening / closing part which is located above the spike body and closes an upper end opening of the spike body so as to be openable and closable; An elastic seal formed with an engaging portion projecting radially outward from an upper side thereof; The elastic seal is externally movably fitted to the upper part of the elastic seal above the engaging part so as to be movable in the vertical direction, and is pressed downward by the tip of the male luer to come into contact with the engaging part of the elastic seal. Due to the deformation, the opening and closing part of the elastic seal is elastically deformed radially outward by the upper end of the spike body and opened, and the opening and closing part is fitted to the spike body. An opening member for sealing between the outer surface of the body and the inner surface of the tip of the male luer; The present invention is characterized in that there is provided a biasing means for biasing the opening member upward and abutting against the inner surface of the housing to set the opening member at a predetermined position.
Note that the upper end surfaces of the housing, the elastic seal, and the opening member may be substantially flush.
A housing connected to a lower end of the spike body and connected to a lower end opening of the spike body and connected to a liquid circuit; and A biasing means may be interposed.
Further, a radial slit may be formed vertically in the opening / closing part. In addition to the elastic seal, the A.P. B. a small-diameter portion connected below the opening / closing portion and having substantially the same outer diameter as the opening / closing portion; A large diameter portion is provided continuously below the small diameter portion and has a larger diameter than the small diameter portion, and an engaging portion is formed in a stepped shape at a boundary portion between the small diameter portion and the large diameter portion, and is formed upward. It may have a planar shape.
Further, the release member may be A.I. B. a pressing portion that constitutes an upper portion of the opening member, is externally movably fitted to the opening and closing portion and the small diameter portion of the elastic seal, and presses the engaging portion; B. an intermediate portion which is continuously provided below the pressing portion, has an inner diameter larger than that of the pressing portion, and is externally movably fitted to the small diameter portion, the engaging portion and the large diameter portion of the elastic seal in the vertical direction; The large portion is provided continuously below the intermediate portion, has an outer diameter larger than that of the intermediate portion, is externally movably fitted to a large diameter portion of the elastic seal, and is urged upward by an urging means. It may have a diameter.
The inside of the housing is A. B. an upper portion of the interior, in which an opening / closing portion and a small-diameter portion of the elastic seal, and a small-diameter hole in which a pressing portion and an intermediate portion of the opening member are located; B. a large-diameter hole continuously provided below the small-diameter hole, in which the large-diameter portion of the elastic seal and the large-diameter portion of the opening member are located; The stopper may be formed in a stepped shape at the boundary between the small-diameter hole and the large-diameter hole, exhibit a planar shape downward, and contact with the large-diameter portion of the opening member by the urging by the urging means.
[0010]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, an example of an embodiment in which the present invention is applied to a mixed injection plug will be described with reference to the drawings. The mixed injection plug includes a housing 1, a spike body (pipe) 2, an elastic seal (member) 3, and an opening member (movable). Cap) 4, a compression coil spring 5, and the like.
[0011]
The housing 1 is hollow at both upper and lower ends, into which a male luer is removably inserted, and has a main body 7 and a connecting body 8. The constituent materials of the main body 7 and the connection body 8 include polycarbonate resin, acrylic resin, hard vinyl chloride resin, high-density polyethylene resin, polypropylene resin, acrylonitrile-butadiene-styrene block copolymer resin, polyamide resin, polyethylene terephthalate resin, Examples include polybutylene terephthalate resin, polyacetal resin, fluorine resin, polyphenylene sulfide resin, polyether sulfone resin, polyether ether ketone resin, and liquid crystal polymer resin. Further, a resin whose strength is enhanced by blending glass fiber, graphite, inorganic filler, carbon nanotube, or the like with the above resin may be used.
[0012]
The main body 7 is hollow at both upper and lower ends, and the upper part is an upstream (male) connecting portion ((male) coupling means, (male) coupling portion) 10 to which a male luer is separably connected, A male screw portion 11 is formed on the outer peripheral surface. On the inner surface of the main body 7, a small-diameter hole 12, which is an inner surface of the upstream-side connecting portion 10, a large-diameter hole 13 having a diameter larger than the small-diameter hole 12, and a larger-diameter than the large-diameter hole 13 are formed. The female screw portion 14 on which the screw is formed is continuously provided downward in the above order. At the boundary between the small-diameter hole 12 and the large-diameter hole 13, a stopper portion 15 having a stepped shape and presenting a planar shape downward is formed.
[0013]
The connecting body 8 has a hollow shape opened at both upper and lower ends, and is inserted and fixed in the lower part of the main body 7. The connecting body 8 has a connecting portion 18, a fitting portion 19 having a larger diameter than the connecting portion 18 and having a male screw formed on the outer peripheral surface, and a downstream side (male) having a smaller diameter than the fitting portion 19. The connecting portions ((male) coupling means and (male) coupling portions) 20 are integrally formed by connecting them downward in the above order. In the inner surface of the connection body 8, an insertion hole 21 formed inside the upper end of the connection part 18 and the fitting part 19, and an insertion hole 21 formed in the remaining part of the fitting part 19 and inside the downstream side connection part 20. A communication hole 22 having a diameter larger than that of the communication hole 22 is provided. The connecting body 8 may be bonded to the main body 7 without providing the fitting portion 19 on the connecting body 8.
[0014]
The connecting portion 18 has a lower portion of the elastic seal 3 fitted and connected thereto. The connecting portion 18 has a smaller diameter than the large-diameter hole 13 of the main body 7 and is located in the lower portion of the large-diameter hole 13. The connection portion 18 has a truncated cone-shaped retaining portion 24 at the upper portion, protrudes radially outward from the lower portion, bites into the inner surface of the elastic seal 3, and inadvertently drops from the connection portion 18 of the elastic seal 3. To prevent
[0015]
The fitting portion 19 is inserted and screwed into the female screw portion 14 of the main body 7 and fixed.
[0016]
The downstream connecting portion 20 projects downward from the lower portion of the female screw portion 14 of the main body 7 and is tapered downward, so that the liquid transfer tube 26 exemplified as a liquid circuit can be separated. It is connected to the. The liquid circuit includes not only a tube for an infusion line or an extracorporeal liquid circuit, but also various liquid bags such as an infusion bag and various devices.
[0017]
The spike body 2 has a pipe shape opened at both upper and lower ends, is disposed in the housing 1 in a vertical direction, and has a lower end opening communicating with the tube 26. A portion excluding the lower portion is disposed in the small diameter hole 12 and the large diameter hole 13 of the main body 7, and the upper end is slightly lower than the upper end of the main body 7. Examples of the constituent material of the spike body 2 include stainless steel and various resins.
[0018]
The elastic seal 3 is in the form of a tube (substantially cylindrical) that can be elastically deformed, and is externally fitted to the spike body 2 from above, and has a disk (column) opening / closing portion 28 and an inner diameter smaller than the opening / closing portion 28. A tubular small-diameter portion 29 having a large diameter and the same outer diameter as the opening / closing portion 28 and a large-diameter portion 30 having an inner diameter and an outer diameter larger than the small-diameter portion 29 are successively provided downward in the above order. By doing so, they are integrally formed. Examples of the constituent material of the elastic seal 3 include natural rubber, synthetic polyisoprene rubber, butyl rubber, chloroprene rubber, silicone rubber, urethane rubber, styrene butadiene rubber, ethylene propylene rubber, acrylic rubber, fluorine rubber, and thermoplastic elastomer. .
[0019]
The opening / closing part 28 is disposed in the upper part of the small-diameter hole 12 of the main body 7 and is located above the spike body 2, and its upper end surface is (substantially) flush with the upper end surface of the main body 7. , The lower end surface is in contact with the upper end surface of the spike body 2 or slightly opposes with a gap. The outer diameter of the opening / closing section 28 is (substantially) equal to the inner diameter of the male luer, or slightly smaller than the inner diameter. In addition, a single (or two orthogonal) radial slits 32 are formed vertically through portions except for the outer peripheral portion of the opening / closing portion 28, and are formed radially outward of the opening / closing portion 28. The slit 32 can be opened by the elastic deformation of.
[0020]
The small-diameter portion 29 is located at an intermediate portion in the vertical direction of the small-diameter hole 12 of the main body 7, and has an inner diameter (substantially) equal to or slightly larger than the outer diameter of the spike body 2. An engagement portion 31 is formed at a boundary between the small diameter portion 29 and the large diameter portion 30 so as to protrude radially outward from the small diameter portion 29 and exhibit a planar shape upward.
[0021]
The large-diameter portion 30 is located at the lower end of the small-diameter hole 12 of the main body 7 and inside the large-diameter hole 13. Have been.
[0022]
The release member 4 presses the elastic seal 3 downward when the male luer is connected, has a substantially cylindrical shape, is fitted over the upper part of the elastic seal 3, and is located between the elastic seal 3 and the main body 7, It is movable (slidable) up and down with respect to the elastic seal 3 and the main body 7. The opening member 4 includes an upper pressing portion 33, an intermediate portion 34 having an inner diameter larger than the pressing portion 33 and having (substantially) the same outer diameter as the pressing portion 33, and an (substantially) same inner diameter as the intermediate portion 34. A large-diameter portion 35 having a larger outer diameter than the intermediate portion 34 is integrally formed by being continuously provided downward in the above order. Since the opening member 4 has a function of pushing down the elastic seal 3 as described above, a material that is not soft is preferable. In order to improve the sterility around the elastic seal 3, an antibacterial agent (silver / zinc-substituted zeolite, silver-supported calcium phosphate, etc.) may be kneaded into the opening member 4. Further, the opening member 4 may be provided with elasticity.
[0023]
The pressing portion 33 is externally fitted to the opening / closing portion 28 and the small-diameter portion 29 of the elastic seal 3, and is located in the small-diameter hole 12 of the main body 7. ) The same or slightly larger than the outer diameter, and the outer diameter is (substantially) equal to or slightly smaller than the inner diameter of the small-diameter hole 12 of the main body 7. ing. When the male luer presses the pressing portion 33 downward, it comes into contact with the engaging portion 31 of the elastic seal 3 to reduce the elastic seal 3 downward by elastic deformation. Due to the contact between the portion 28 and the upper end of the spike body 2, the opening / closing portion 28 is elastically deformed radially outward, the slit 32 of the opening / closing portion 28 is opened, and the opening / closing portion 28 is opened, and the spike body 2 is opened. The upper end opening is opened, and the opening / closing portion 28 is fitted on the spike body 2 to seal between the outer surface of the spike body 2 and the inner surface of the tip of the male luer.
[0024]
The intermediate portion 34 is externally fitted to the small diameter portion 29 and the large diameter portion 30 of the elastic seal 3, and is located inside the small diameter hole 12 and the large diameter hole 13 of the main body 7. The outer diameter of the large diameter portion 30 is slightly larger.
[0025]
The large-diameter portion 35 is externally fitted to the large-diameter portion 30 of the elastic seal 3 and is located in the upper portion of the large-diameter hole 13 of the main body 7, and its outer diameter is substantially the same as the inner diameter of the large-diameter portion of the main body 7. It is the same or slightly smaller than the inner diameter, and faces the stopper portion 15.
[0026]
The compression coil spring 5 is exemplified as an urging means. The compression coil spring 5 is elastically interposed between the upper surface of the fitting portion 19 of the connecting body 8 and the large diameter portion 35 of the opening member 4 so that the opening member 4 is moved upward. And the large-diameter portion 35 of the opening member 4 is brought into contact with the stopper portion 15 of the main body 7 so that the opening member is set to a predetermined position (standby position, non-connection position). The upper end surfaces of both elastic seals 3 are (substantially) flush with each other. In addition, as a constituent material of the spring 5, a metal, a resin, and the like can be cited, but a metal having a large elastic recovery force (elastic recovery force, elastic force) is preferable. Further, the urging means may be a rubber tube. In this case, the rubber tube may be formed separately from the opening member 4 or may be integrated.
[0027]
In the above configuration example, when performing infusion, blood collection, and the like via the co-injection plug, after disinfecting the upper end surface of the co-infusion plug, for example, as shown in FIG. 2, the tip of the syringe 37 exemplified as a male luer 38 is inserted into the small-diameter hole 12 of the main body 7 of the housing 1 from the upper end opening.
[0028]
At this time, as shown by the phantom line in FIG. 3, a syringe 37 having a lock member 40 having a female screw portion formed on the inner surface is used, and the female screw portion of the lock member 40 is used as the male screw of the main body 7. By screwing the syringe 37 to the portion 11, the above-described inserted state of the syringe 37 can be reliably maintained.
[0029]
Due to the insertion of the tip 38 of the syringe 37, the opening member 4 is pressed downward, and the opening member 4 is pressed down against the elastic force of the spring 5. As a result, the pressing portion 33 of the opening member 4 comes into contact with the engaging portion 31 of the elastic seal 3, and the elastic seal 3 is contracted while being elastically deformed downward.
[0030]
Due to this reduction and the contact between the opening / closing portion 28 of the elastic seal 3 and the upper end of the spike body 2, the opening / closing portion 28 is elastically deformed radially outward as shown in FIG. The spiked body 2 is opened by opening the opening / closing part 28 to open the upper end opening of the spike body 2, and the opening / closing part 28 is fitted to the spike body 2. The space between the lower inner surfaces of the chip 38 is sealed.
[0031]
Thus, the interior of the syringe 37 communicates with the tube 26 via the communication holes 22 of the spike body 2 and the connecting body 8 in a state where the outer surface of the spike body 2 and the inner surface of the lower part of the tip 38 of the syringe 37 are sealed. Infusion, blood collection, etc. can be performed in the same manner as in the prior art.
[0032]
When the infusion, blood collection and the like are completed, the tip 38 of the syringe 37 is removed from the main body 7 of the housing 1. As a result, the resilient force of the spring 5 raises the opening member 4, the large-diameter portion 35 contacts the stopper portion 15 of the main body 7, and the large-diameter portion 30 of the elastic seal 3 reduces the resilient force. As a result, it extends upward and returns to its original size. At the same time, the small diameter portion 29 and the opening / closing portion 28 also rise and return to their original positions, whereby the slit 32 of the opening / closing portion 28 is closed, the opening / closing portion 28 is closed, and the upper end opening of the spike body 2 is closed. Will be closed.
[0033]
According to the above configuration example, the lower end of the tip 38 of the syringe 37 presses not the elastic seal 3 but the opening member 4 located radially outward of the elastic seal 3. Contact with the upper end surface of the member and the spike body 2 can be prevented. Therefore, even if germs are attached to the lower end of the tip 38 of the syringe 37, the germs may only adhere to the upper end surface of the opening member 4. Adhesion to the body 2 can be prevented.
[0034]
Even when germs adhere to the lower end of the tip 38 of the syringe 37 or the upper end surface of the opening member 4, when the opening member 4 is pressed by the syringe 37, the opening and closing portion 28 of the elastic seal 3 connects the outer surface of the spike body 2 to the syringe. Since the space between the lower inner surfaces of the tips 38 of the 37 is sealed, there is no fear that the liquid transferred between the syringe 37 and the spike body 2 is contaminated by various bacteria. That is, according to the above configuration example, the syringe 37 and the co-injection plug can be connected substantially aseptically (aseptically).
[0035]
In the embodiment, the present invention is applied to a co-injection plug, but the present invention is applicable to various other medical valves.
[0036]
【The invention's effect】
As described in detail above, according to the present invention, a male luer and a medical valve can be connected in a substantially aseptic condition.
[Brief description of the drawings]
FIG. 1 is a cross-sectional view illustrating an example of an embodiment of the present invention.
FIG. 2 is an operation state diagram of FIG. 1;
FIG. 3 is an operation state diagram of FIG. 2;
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Housing 2 Spike body 3 Elastic seal 4 Opening member 5 Compression coil spring (biasing means)
7 Body 8 Connector 12 Small diameter hole 13 Large diameter hole 15 Stopper 26 Liquid transfer tube (liquid circuit)
28 Opening / closing part 29 Small diameter part 30 Large diameter part 32 Slit 31 Engagement part 33 Pressing part 34 Middle part 35 Large diameter part 37 Syringe 38 Tip

Claims

A medical valve to which a male luer is separably connected,
A. A housing into which the upper end is open and into which a male luer tip is removably inserted,
B. A spike body having a pipe shape opening at an upper end, disposed vertically in the housing, and a lower part connected to a fluid circuit;
C. An elastically deformable tubular shape, which is fitted over the spike body, and an upper part is an opening / closing part which is located above the spike body and closes an upper end opening of the spike body so as to be openable and closable; An elastic seal formed with an engaging portion projecting radially outward from an upper side thereof;
D. The elastic seal is externally movably fitted to the upper part of the elastic seal above the engaging part so as to be movable in the vertical direction, and is pressed downward by the tip of the male luer to come into contact with the engaging part of the elastic seal. Due to the deformation, the opening and closing part of the elastic seal is elastically deformed radially outward by the upper end of the spike body and opened, and the opening and closing part is fitted to the spike body. An opening member for sealing between the outer surface of the body and the inner surface of the tip of the male lure,
E. FIG. A medical valve having an urging means for urging an opening member upward and bringing the opening member into contact with an inner surface of a housing to set a predetermined position.

The medical valve according to claim 1, wherein the upper end surfaces of the housing, the elastic seal, and the opening member are substantially flush with each other.

The housing is
A spike body is connected to the lower part of the spike body, the spike body communicates with a lower end opening of the spike body, and has a connection body connected to the liquid circuit;
3. The medical valve according to claim 1, wherein an urging means is interposed between the connecting member and the opening member.

The medical valve according to any one of claims 1 to 3, wherein a radial slit is formed vertically in the opening / closing portion.

Elastic seal, in addition to the opening and closing part and the engaging part,
A. A small-diameter portion continuously provided below the opening / closing portion and having substantially the same outer diameter as the opening / closing portion;
B. It has a large-diameter portion that is continuously provided below the small-diameter portion and has a larger diameter than the small-diameter portion,
The medical valve according to any one of claims 1 to 4, wherein the engagement portion is formed in a stepped shape at a boundary between the small diameter portion and the large diameter portion, and has a planar shape upward.

The opening member is
A. A pressing portion that constitutes an upper portion of the opening member, is externally movably fitted to the opening / closing portion and the small diameter portion of the elastic seal in a vertical direction, and presses the engaging portion;
B. An intermediate portion which is continuously provided below the pressing portion, has an inner diameter larger than the pressing portion, and is externally movably fitted vertically to the small diameter portion, the engaging portion and the large diameter portion of the elastic seal,
C. The large portion which is continuously provided below the intermediate portion, has an outer diameter larger than that of the intermediate portion, is externally movably fitted to the large diameter portion of the elastic seal, and is urged upward by an urging means. The medical valve according to claim 5, which has a diameter portion.

The inside of the housing
A. Constituting the upper part of the inside, the inside thereof, the opening and closing part and the small diameter part of the elastic seal, the small diameter hole where the pressing part and the middle part of the opening member are located,
B. A large-diameter hole that is provided continuously below the small-diameter hole and in which the large-diameter portion of the elastic seal and the large-diameter portion of the opening member are located,
C. 7. A stopper formed at the boundary between the small-diameter hole and the large-diameter hole so as to be stepped, exhibiting a planar shape downward, and being contacted by the large-diameter portion of the opening member by the urging means. Medical valve.