JP3565609B2

JP3565609B2 - Lysis solution injection set

Info

Publication number: JP3565609B2
Application number: JP06294495A
Authority: JP
Inventors: 敏博菊池; 忠敏内田; 隆英岡本; 修杉田; 佳夫塚田; 信夫中塚
Original assignee: Nipro Corp
Current assignee: Nipro Corp
Priority date: 1995-03-22
Filing date: 1995-03-22
Publication date: 2004-09-15
Anticipated expiration: 2019-09-15
Also published as: JPH08257101A

Description

【０００１】
【産業上の利用分野】
本発明は溶解液注入セットに関する。さらに詳しくは、本発明は容器内の乾燥薬剤を他の容器の溶解液と混合して液状薬剤を調製するのに適した溶解液注入セットに関する。
【０００２】
【従来の技術】
従来より病院等の医療機関においては、バイアル等の薬剤容器に入った粉末薬剤あるいは凍結乾燥薬剤などの乾燥製剤を溶解して輸液として点滴注射に用いている。このような乾燥製剤を薬液に調製する操作は、薬剤の入った容器とその薬剤を溶解するための溶解液の入った容器とを両頭針あるいは連結管等の接続用具を用いて接続し、溶解液を薬剤の入った容器に移すことにより行っている。ところがこの操作は煩雑で手間がかかる上に、外気中で薬剤の入った容器に接続するための穴を開ける操作を行うので、中の薬剤が汚染される虞がある。
そこで上記のような問題を解消するものとして、特表昭６１−５０１１２９号公報や特開平２−１２７７号公報、特開平３−３７０６７号公報などに示される完全な無菌操作を目的とするものや、特開昭５９−２０９５３５号公報や特開昭６２−１３７０５６号公報、特開平２−４３７５号公報、特開昭６０−２１０２６１号公報などに示される、完全な無菌操作は出来ないが薬剤と溶解液の組合せを任意に選択することの出来る実質的に無菌的な操作を可能とするもの、などが提案されている。
【０００３】
特表昭６１−５０１１２９号に示されるものは、薬剤容器の収容されたカプセルと溶解液の収容された可撓性容器とがチューブで接続されたものであり、チューブ内に設けられた連通手段によって薬剤容器と可撓性容器が連通され、薬剤と溶解液とが無菌的に混合されるようになっている。また、特開平２−１２７７号公報に示されるものは、薬剤容器の収容されたカプセルをその結合部で溶解液容器の口部と接続し、カプセルの結合部側に連通順序規制手段を備えた連通手段を介在させたもので、連通手段により薬剤容器が刺通されたのちに溶解液容器が刺通されて二つの容器が連通され、薬剤と溶解液とが無菌的に混合されるようになっており、特開平３−３７０６７号公報に示すものは、薬剤容器と連通手段と溶解液容器をこの順序で配列して合成樹脂製シートで密封した上、薬剤容器と溶解液容器の間にシートの上から容器支持手段を介在させたもので、無菌的な連通・混合操作を行う時まで二つの容器が接近しないようになっている。
【０００４】
一方、特開昭５９−２０９５３５号公報には、可撓性壁体部材を有する密封された第一の可撓性容器と、この可撓性容器の壁体部材に貫通して固定でき、取外し得るストッパーを有する第二の容器と、ストッパーと噛み合う部分を有するストッパー取外し部材からなり、第一の容器に第二の容器を貫通してストッパーをストッパー取外し部材と噛み合わせた後、第一の可撓性容器の密封バリヤーと一緒にストッパーを第二の容器から取外して二つの容器の内容物を混合出来るようにした装置が開示されており、特開昭６２−１３７０５６号公報および特開平２−４３７５号公報に示されるものは、前記第二の容器を改良したものである。また、特開昭６０−２１０２６１号公報に示すものは、特開昭５９−２０９５３５号公報に開示された装置を改良したものである。
【０００５】
前者の特表昭６１−５０１１２９号公報等に示される装置は、その構成上、薬剤容器と溶解液容器とがペアーになっているため、調製される薬剤が一つに限定されてしまうという欠点を有しているものの、完全な無菌操作を可能とするものであり、また、後者の特開昭５９−２０９５３５号公報等に示される装置は、機構が複雑であり、ストッパーが第一の容器内に落とされるなど欠点も多く、また、完全な無菌操作も出来ないが、実質的に無菌的な操作が可能であり、薬剤と溶解液の組合せを任意に選択することの出来るものであるため、医療現場では必要に応じて適宜両者の使い分けが必要になっている。
【０００６】
【発明が解決しようとする課題】
本発明は、上記の様な事情に鑑みてなされたもので、前記の特表昭６１−５０１１２９号公報等に示される装置と同等の無菌操作が可能であり、構造が簡単で、操作が容易で、しかも携帯可能な、安価な溶解液注入セットを提供することを目的とする。
【０００７】
【課題を解決するための手段】
本発明は上記の課題を解決するために、その内壁に容器を保持するための複数の縦リブからなる容器保持手段を備えた有底筒状のカプセルと、該カプセルに上向きに収容され保持される薬剤容器と、前記カプセルの開口部に回動自在に冠着されカプセルの開口部を密封するキャップ部材と、口部と底部を有する容器であって該キャップ部材に収容され支持される容器キャリアと、該容器キャリアに収容され保持される溶解液容器と、容器キャリアと薬剤容器の間に位置するようにカプセル内に収容され、該カプセルの内壁によって上下方向スライド自在に保持される連通手段、および前記カプセルに設けたキャップ部材取り外し手段からなり、キャップ部材と容器キャリアとカプセルの間に、キャップ部材を回転させた時に容器キャリアを回転させることなく薬剤容器側にスライドさせるガイド手段を設け、キャップ部材を回転させることにより容器キャリアと一緒に溶解液容器を薬剤容器方向に移動させ、該溶解液容器と薬剤容器を連通手段によって連通すると共に、薬剤容器と容器キャリアと溶解液容器と連通手段とが、カプセルとカプセルの開口部に冠着されるキャップ部材によって密封されてなる携帯可能な溶解液注入セットを採用している。
【０００８】
ここで、ガイド手段は、キャップ部材の内壁に設けられた複数の平行な螺旋溝と、カプセルの内壁に設けられた複数の縦溝と、容器キャリアの外壁に設けられた複数の第１および第２のスライド突起とからなり、第１のスライド突起が螺旋溝にスライド自在に嵌め込まれるとともに、第２のスライド突起が縦溝にスライド自在に嵌め込まれる様に構成することができる。また、容器キャリアから溶解液容器を取り出し易くするために容器キャリアの底部に透孔を設けてもよく、カプセルから溶解液容器および薬剤容器を取り出しやすくするために、連通手段に、連通操作完了時に溶解液容器の口部および薬剤容器の口部とそれぞれ係合し、係合した状態の該２つの容器をカプセルから出した時に容易に解除可能な第１および第２の係合手段を設けてもよい。そしてこのような解除可能な構成は、例えば、第１の係合手段をハブの表面に設けた可撓性の係合腕で構成し、該係合腕に溶解液容器の口部と係合する係合突起を形成するとともに、第２の係合手段をハブの裏面に設けた可撓性の係合腕で構成し、該係合腕に溶解液容器の口部と係合する係合突起を形成することにより達成される。また、連通手段の係合腕に溶解液容器が連通手段によって連通されるのを妨害する可撓性の連通妨害手段を設け、連通手段により薬剤容器が連通された後に連通妨害手段による妨害が解除され、溶解液容器が連通されるように構成してもよい。
【０００９】
【作用】
上記の構成によれば、キャップ部材を例えば時計方向に回転させると、ガイド手段の働きにより、例えばガイド手段がキャップ部材の螺旋溝と容器キャリアの第１および第２のスライド突起、カプセルの縦溝からなっている場合には、容器キャリアの第１のスライド突起がキャップ部材の螺旋溝に沿ってスライドするが、容器キャリアの第２のスライド突起がカプセルの縦溝に沿ってスライドするため、溶解液容器を収容した容器キャリアは回転すること無く薬剤容器側にスライドする。この時、溶解液容器と薬剤容器の間に介在する連通手段（例えば両頭針）も容器キャリアと一緒にスライドして薬剤容器に達し、その両端の刃先で溶解液容器と薬剤容器を連通する。溶解液容器と薬剤容器の連通後は、カプセルからキャップ部材を取り外し、次いで一体化された容器キャリアと薬剤容器とを取り出し、溶解液容器の溶解液と薬剤容器の薬剤を良く混合すれば薬液を調製することができる。点滴治療を行う場合には、調整された薬液を例えば溶解液容器側に移行させてその薬液取り出し口に輸液セット等を接続すればよい。
【００１０】
【実施例】
次に本発明の実施例について図面に基づいて説明する。
図１は本発明の一実施例に係る溶解液注入セットの縦断面図であり、図２は図１に示す薬剤容器の縦断面図、図３は図１に示す溶解液容器の縦断面図、図４は溶解液容器の他の実施例を示す縦断面図、図５は図１に示す連通手段（両頭針）の縦断面図、図６は図５の底面図、図７は図５の平面図、図８は連通手段の他の実施例を示す縦断面図、図９は図１に示す容器キャリアの縦断面図、図１０は図９の底面図、図１１は図１に示すカプセルの縦断面図、図１２は図１１の平面図、図１３は図１に示すキャップの縦断面図、図１４は図１３の底面図、図１５は図１に示すキャップ取り外し手段の平面図、図１６は図１５のＸ−Ｘ線断面図である。
図１に示すように、本発明の溶解液注入セットは、有底筒状のカプセル１と、このカプセル１に上向きに収容され保持される薬剤容器２と、カプセル１に回動自在に冠着されるキャップ部材３と、このキャップ部材３に収容支持される容器キャリア４と、この容器キャリア４に収容保持される溶解液容器５、および容器キャリア４と薬剤容器２の間にスライド自在に保持される連通手段６からなる。キャップ部材を回転させることにより容器キャリア４を回転させることなく薬剤容器２側にスライドさせ、容器キャリア４に収容保持された溶解液容器５と薬剤容器２を連通手段６によって連通するようになっている。
【００１１】
カプセル１は薬剤容器２と連通手段６、容器キャリア４の少なくとも第２の係合突起４２部分を収容する有底筒状の容器であり、通常、ポリエチレンやポリプロピレン、ポリエステル、ポリ塩化ビニル、ポリカーボネート、ＡＢＳ樹脂などの合成樹脂で形成される。カプセル１は図１１〜１２に示すように底部１１と開口部１２を有しており、その開口部１２の外壁には後述のキャップ部材取り外し手段７と係合する環状突起１３が形成されている。カプセル１の内壁にはその開口部１２から底部１１方向に後述の容器キャリア４の第２のスライド突起４２が嵌め込まれスライドするための複数の縦溝１５が形成されており（図１１では２本形成されている）、カプセル１の中間部内壁には後述の連通手段（通常、両頭針を使用するので、以下、両頭針という）６の係合腕６４がスライドする縦方向の両頭針係合溝１７が形成されている（図１１では４本形成されている）。両頭針係合溝１７はその一部または全部を縦溝１５と一体に形成してもよい（図１１では２本の両頭針係合溝が縦溝の延長上に形成されている）。両頭針係合溝１７には横方向に複数の係合リブ１６が形成されており（図１１では４本形成されている）、両頭針６の係合腕６４と係合してこれが容易に下方移動しないように機能している。係合リブ１６は、両頭針６の位置決めの機能も有している。また、カプセル１の底部１１には開口部１２方向に薬剤容器２を保持するための複数の縦リブ１４が形成されている（図１１では４本形成されている）。尚、縦溝１５は１本でも支障はないが、容器キャリア４の安定性を考慮した場合、２本以上形成するのが好ましい。
【００１２】
カプセル１には薬剤容器２と両頭針６と内部に溶解液容器５を収容した容器キャリア４が、図１に示すように、この順序で、薬剤容器２と両頭針６はそれぞれその口部２１とその上部穿刺針６２を開口部１２側（以下、上方側という）に向けて、容器キャリア４は、溶解液容器５（その口部５１が第２のスライド突起４２側にくるように容器キャリア４内に収容されている）の口部５１が底部１１側を向くように、その第２のスライド突起４２側を底部１１側（以下、下方側という）に向けて収容されている。
薬剤容器２は一般にガラス製であり、図２に示すように、その口部２１はゴム栓２２などの密封部材で密閉されており、ゴム栓２２はさらにアルミなどで作られたかしめ部材２３で巻締めされ、口部２１に固定されている。薬剤容器２としては市販の薬剤容器が使用可能であり、溶解液注入セットの組み立てに際しては、かしめ部材２３はその天面が取り外され、両頭針６の下部穿刺針６３で穿刺する位置に透孔２４が形成される。尚、薬剤容器２の内部には粉末製剤や凍結乾燥製剤などの乾燥製剤が収容されているが、図面では省略している。
【００１３】
連通手段として採用される両頭針６は、図１に示すように薬剤容器２と溶解液容器５の間に配置されており、通常、ステンレス鋼（ＳＵＳ１０４が好ましい）または合成樹脂製のカヌラと合成樹脂製のハブから構成されている。切れ味を重視する場合にはステンレス鋼のカヌラが好ましいが、使用後の廃棄の問題および一体成形できるという利点を考慮すれば合成樹脂製の両頭針が好ましい。合成樹脂としては例えばＡＢＳ樹脂や高密度ポリエチレン、ポリカーボネートなどが好適に採用される。
【００１４】
両頭針６は容器キャリア４とともに下方にスライドして薬剤容器２の口部２１のゴム栓２２を刺通し、さらには後述の溶解液容器５の口部５１のゴム栓５２および閉鎖膜５３を刺通することができるように、図５〜７に示すように、ハブ６１と、溶解液容器５のゴム栓５２を刺通する上部穿刺針６２および、薬剤容器２のゴム栓２２を刺通する下部穿刺針６３からなり、ハブ６１の先端にはハブ６１の鉛直方向に係合腕６４が設けられている。そして、この係合腕６４にはその先端にカプセル１の両頭針係合溝１７と接触しこれに沿ってスライドする突出部分６４１が設けられており、この突出部分６４１は縦溝１５の係合リブ１６と容易に解除可能に係合している。
【００１５】
両頭針６のハブ６１の表面にはこれと鉛直方向に図５に示すような可撓性の連通妨害手段６５を設けてもよい。連通妨害手段６５は、溶解液容器５の口部５１を受けて溶解液容器５の下方移動を妨害する膨部６５１と、可撓性を有する脚６５２からなり、膨部６５１に係る荷重が所定の大きさになると脚６５２が外側に撓んで溶解液容器５の口部５１の下方移動を許容するようになっている。従って、例えば溶解液容器５の口部５１の下方移動を許容する荷重の大きさが、両頭針６の下部穿刺針６３による薬剤容器２のゴム栓２２の刺通抵抗よりも大きくなるように、溶解液容器５の口部５１を受ける膨部部分６５３の形状および脚６５２の太さを選択することにより、両頭針６による溶解液容器５のゴム栓５２および薬剤容器２のゴム栓２２の刺通順序を確実に制御することができる。すなわち、下部穿刺針６３によって薬剤容器２のゴム栓２２が刺通された後でなければ、上部穿刺針６２によって溶解液容器５のゴム栓５２が刺通されないようにすることができる。
【００１６】
両頭針６のハブ６１には連通操作完了時に溶解液容器５の口部５１および薬剤容器２の口部２１とそれぞれ係合し、係合した状態の２つの容器２、５をカプセル１から出した時に容易に解除可能な係合手段を設けてもよい。このような係合手段としては可撓性の脚とこの脚の先端に内向きに設けられたフックからなる構成が採用できる。図８にはこのような係合手段として、溶解液容器５の口部５１と係合する第１の係合手段６６と、薬剤容器２の口部２１と係合する第２の係合手段６７が示されている。第１の係合手段６６は別途設けることも可能であるが、図では連通妨害手段６５に設けられている。すなわち脚６５２は第１の係合手段６６の脚でもあり、フックは膨部６５１の上部穿刺針６２側の下面が脚６５２と直角または鋭角になるようにすることにより形成される。第２の係合手段６７は可撓性の脚６７１とこの脚６７１の先端に内向きに設けられたフック６７２からなる。これらの係合手段６６、６７は可撓性の脚６５２、６７２を有しているので、連結された薬剤容器２、両頭針６、溶解液容器５をカプセル１から取り出した後は、手などで容易に解除することができる。
【００１７】
溶解液容器５を収容・保持してこれを両頭針６側にスライドさせる容器キャリア４は通常、カプセル１と同様の合成樹脂で形成された筒状の容器であり、図９〜１０に示すように、底部には後述のキャップ部材３の螺旋溝３３に沿ってスライドする第１のスライド突起４１が設けられ、口部にはカプセル１の縦溝１５に沿ってスライドする第２のスライド突起４２が設けられている。そして、口部には溶解液容器５を挿着しやすいように複数のスリット４３が形成されており、底部には必要ならば溶解液容器５を取り出しやすいように透孔４４が形成される。第１のスライド突起４１および第２のスライド突起４２は、カプセル１の縦溝１５および後述のキャップ部材３の螺旋溝３３と協働して、キャップ部材３の回転運動を直線運動に変え、容器キャリア４を真っ直ぐに両頭針６および薬剤容器２側にスライドさせるガイド手段を構成している。すなわち、図１３に示すようなキャップ部材３の場合、キャップ部材３を時計方向に回転させると、キャップ部材３の螺旋溝３３に容器キャリア４の第１のスライド突起４１が嵌め込まれているので、容器キャリア４はキャップ部材３とともに回転しようとする。ところが容器キャリア４の第２のスライド突起４２がカプセル１の縦溝１５に嵌め込まれているため、容器キャリア４は回転することが出来ず、第１のスライド突起４１がキャップ部材３の螺旋溝３３に沿ってスライドして、容器キャリア４を下方に移動させる。尚、第１のスライド突起４１および第２のスライド突起４２は複数本設けるのが好ましいが（図９では２本設けている）、機能的には１本であっても構わない。
【００１８】
容器キャリア４に収容される溶解液容器５は、一般に容器本体５５がポリエチレンやポリプロピレン、ポリエステルなどの比較的柔らかい合成樹脂で形成された押圧変形自在な容器であり、通常、図３に示すような連通口と薬液取り出し口を兼ねた口部５１を有するものが採用される。図３に示す口部５１は、容器本体５５の閉鎖膜５３上にゴム栓５２と押さえ部材５４からなる閉鎖部材を溶着して形成したものであり、ゴム栓５２から溶解液への溶出を防ぐことのできる構造になっている。溶解液容器５には図４に示すように口部５１と独立に薬液取り出し口５６１を設け、口部５１を連通口として使用するように構成してもよい。この場合、薬液取り出し口５６１の構造は口部５１と同様の閉鎖膜５６３とゴム栓５６２、押さえ部材５６４からなる構成を採用することができるが、キャップ部材３を取り外した後、手などで汚染される危険の大きいゴム栓５６２は合成樹脂のフィルムなどのカバーシート５７で保護するのが好ましい。
【００１９】
薬剤容器２、連通手段（両頭針）６および溶解液容器５がこの順序で収容されたカプセル１の開口部１２にはキャップ部材３とキャップ部材取り外し手段７が取り付けられる。キャップ部材取り外し手段７はカプセル１の開口部１２に装着されたキャップ部材３の上から取り付けるように構成することも出来るが、このような構成ではキャップ部材３を取り外して内部の薬剤容器２や溶解液容器５を取り替えること（所謂改竄）が可能なので、図１では好ましい構造としてキャップ部材取り外し手段７をカプセル１の開口部１２に取り付け、その上からキャップ部材３を強制的に嵌め込む（所謂無理嵌め）構成を採用している。
【００２０】
図１３〜１４に示すキャップ部材３は、改竄防止機能を備えたキャップ部材３であり、図１５〜１６に示すキャップ部材取り外し手段７と組み合わせで用いるものである。キャップ部材３は、天面３１とスカート部３２からなり、通常、容器キャリア４と同様の合成樹脂で筒状に形成され、その側壁であるスカート部３２の下端には、キャップ部材３とカプセル１の間を気密にシールするシール部材８を装着するためのシール部材装着溝３６が形成されている。そして、図１３に示すように、その側壁であるスカート部３２の内壁には容器キャリア４の第１のスライド突起４１と係合する螺旋溝３３が形成されており、スカート部３２の下端部内壁には、後述のキャップ部材取り外し手段７の溝７２に回動自在に嵌め込まれる突起３５が設けられている。螺旋溝３３はスカート部３２内壁を削ることにより形成することができるが、図１３に示すように螺旋突条３４を設けることにより形成してもよい。
【００２１】
キャップ部材取り外し手段７は、カプセル１からキャップ部材３を取り外し、薬剤容器２や両頭針６、溶解液容器５を取り出せるようにするもので、図１５〜１６に示すようにリング状に形成される。キャップ部材取り外し手段７はその内壁にカプセル１の開口部１２の環状突起１３と回動自在に係合する環状突起７１を有しており、その外壁にはキャップ部材３の下端部内壁の突起３５と回動自在に係合する溝７２が形成されている。この溝７２は断続的に形成され、溝の切れ目７３の部分は、溝７３を構成する上方の側壁部分が切り欠かれた形状、すなわち段差状に形成されており、キャップ部材３の突起３５の長さはこの溝の切れ目７３の長さより短くなっている。そして時計方向に向かう溝７２と溝の切れ目７３の間に係止突起７４が設けられており、キャップ部材３を時計方向に回したときに、キャップ部材３の突起３５がキャップ部材取り外し手段７の係止突起７４と衝突して、キャップ部材取り外し手段７がキャップ部材３と一緒に回転するようになっている。そして、キャップ部材取り外し手段７がキャップ部材３と一緒に回転している間、キャップ部材３の突起３５がキャップ部材取り外し手段７の溝７２の中に在り、次いでキャップ部材３を反時計方向に回した時には突起３５が溝の切れ目７３に来るようになっている。この場合、突起３５が溝の切れ目７３より短く形成されているため、突起３５が溝の切れ目７３に来たときにキャップ部材３を上方に移動させると、キャップ部材３はキャップ部材取り外し手段７から外れるようになっている。
【００２２】
ここで、キャップ部材取り外し手段７は、図１に示すように、殆どキャップ部材３のスカート部３２の下端部で被われているので、キャップ部材取り外し手段７のみを手で回すことは不可能である。従って、キャップ部材３を取り外すとき、すなわちキャップ部材３を反時計方向に回したときにキャップ部材取り外し手段７がキャップ部材３と一緒に回転しないように、キャップ部材取り外し手段７の上端部内壁に回転防止突起７５を設け、カプセル１の開口部１２外壁に設けた突条１８と係合するようにしている。そして、キャップ部材３を時計方向に回して薬剤容器２と溶解液容器５を両頭針６で連通したときに初めて、丁度カプセル１の突条１８がこの回転防止突起７５を乗り越えるようにしているので、連通操作が完了しなければキャップ部材３をカプセル１から取り外すことが出来ないようになっている。
【００２３】
尚、図１５〜１６では、溝７２と溝の切れ目７３および係止突起７４からなるキャップ部材取り外し機構をキャップ部材取り外し手段７の外壁に形成しているが、キャップ部材取り外し機構をキャップ部材取り外し手段７の内壁に形成し、キャップ部材３のスカート部３２の下端部の外壁に形成した突起（図示していないが、突起３５に相当するもの）と組み合わせてもよい。また、キャップ部材取り外し機構と同様の機構をキャップ部材３の内壁または外壁に設け、キャップ部材取り外し手段７の外壁に設けたキャップ部材３の突起３５と同様の突起（図示していない）と組み合わせるようにしてもよい。但し、キャップ部材３は、その螺旋溝３３と容器キャリア４の第１のスライド突起とが係合する関係で、使用前には反時計方向に回転させることができなくなっているが、キャップ部材３の外壁にキャップ部材取り外し機構または突起を設けた場合には、キャップ部材取り外し手段７だけを反時計方向に回してキャップ部材３を取り出すことができるので、別途、使用前にキャップ部材３の取り外しができないようにする手段を設ける必要がある。
【００２４】
次に、本発明の溶解液注入セットの使用について図１を用いて説明する。
キャップ部材３を時計方向に回すと、容器キャリア４の第１のスライド突起４１がキャップ部材３の螺旋溝３３に沿ってスライドするが、容器キャリア４の第２のスライド突起４２がカプセル１の縦溝１５に沿ってスライドするため、溶解液容器５を収容した容器キャリア４は回転すること無く薬剤容器２側にスライドする。そして、溶解液容器５の口部５１が、これと薬剤容器２の間に介在する連通手段（両頭針６）の連通妨害手段６５に衝突すると、両頭針６も容器キャリア４と一緒にスライドして薬剤容器２に達し、その下部穿刺針６３で薬剤容器２のゴム栓２２を刺通する。下部穿刺針６３による薬剤容器２のゴム栓２２の刺通が完了する位置では、両頭針６のハブ６１が薬剤容器２の口部２１に衝突して、両頭針６の下方移動が阻止される。この時、溶解液容器５の口部５１によって両頭針６の連通妨害手段６５に加えられる荷重が大きくなるので、連通妨害手段６５の脚６５２が外側に撓み、口部５１が連通妨害手段６５の膨部６５１から外れる。そして、溶解液容器５は下方に移動し、その口部５１のゴム栓５２が上部穿刺針６２によって刺通される。こうして薬剤容器２と溶解液容器５は両頭針６を介して連通される。溶解液容器５と薬剤容器２の連通後は、キャップ部材３を反時計方向に回せば、キャップ部材取り外し手段７とキャップ部材３の係合を容易に解除することができる。キャップ部材取り外し手段７とキャップ部材３の係合を解除し、カプセル１からキャップ部材３を取り外し、次いで一体化された容器キャリア４と両頭針６と薬剤容器２とを取り出し、溶解液容器５の溶解液を両頭針６の薬液通路６８を通して薬剤容器２内に移行させ、溶解液を薬剤容器２内の薬剤と良く混合すれば薬液を調製することができる。点滴治療を行う場合には、調整された薬液を例えば溶解液容器５側に移行させてその薬液取り出し口に輸液セット等を接続すればよい。
また、薬剤容器２の口部２１にスプレーノズルを装着すれば、噴霧液として使用することもできる。
尚、溶解液の移行および混合操作はカプセル１内に収容した状態で行うことも可能であることは勿論である。また、溶解液容器５には薬液取り出し口５６１の代わりに予めスプレーノズルを取り付けておくことも可能である。
【００２５】
【発明の効果】
以上説明してきたことから明らかなように、本発明の溶解液注入セットを採用することにより、次のような効果を奏することができる。
▲１▼無菌的な操作が可能なので、細菌の混入などによる感染を防止することができる。
▲２▼操作が容易なので、操作の手間が省け、人件費の節約や人手不足に対応することができる。
▲３▼連通妨害手段を設けることにより連通順序を規制することが可能であり、この場合、誤操作の心配が無いので、患者自信による操作が可能であり、ホームケア商品として採用できる。
▲４▼溶解液注入セットを安価に提供することができる。
▲５▼薬剤容器と溶解液容器の連通機構がカプセル内に収容された構成になっているので、破損の心配がなく、携帯も可能である。
【図面の簡単な説明】
【図１】本発明の一実施例に係る溶解液注入セットの縦断面図である。
【図２】図１に示す薬剤容器の縦断面図である。
【図３】図１に示す溶解液容器の縦断面図である。
【図４】溶解液容器の他の実施例を示す縦断面図である。
【図５】図１に示す連通手段（両頭針）の縦断面図である。
【図６】図５の底面図である。
【図７】図５の平面図である。
【図８】連通手段の他の実施例を示す縦断面図である。
【図９】図１に示す容器キャリアの縦断面図である。
【図１０】図９の底面図である。
【図１１】図１に示すカプセルの縦断面図である。
【図１２】図１１の平面図である。
【図１３】図１に示すキャップの縦断面図である。
【図１４】図１３の底面図である。
【図１５】図１に示すキャップ取り外し手段の平面図である。
【図１６】図１５のＸ−Ｘ線断面図である。
【符号の説明】
１カプセル
１３環状突起
１４縦リブ
１５縦溝
１６係合リブ
１７両頭針係合溝
１８突条
２薬剤容器
３キャップ部材
３３螺旋溝
３５突起
３６シール部材装着溝
４容器キャリア
４１第１のスライド突起
４２第２のスライド突起
５溶解液容器
５７カバーシート
６両頭針（連通手段）
６２上部穿刺針
６３下部穿刺針
６４係合腕
６５連通妨害手段
６６第１の係合手段
６７第２の係合手段
７キャップ部材取り外し手段
７２溝
７３溝の切れ目
７４係止突起
７５回転防止突起
８シール部材[0001]
[Industrial applications]
The present invention relates to a lysate infusion set. More specifically, the present invention relates to a dissolving solution injection set suitable for preparing a liquid drug by mixing a dry drug in a container with a dissolving solution in another container.
[0002]
[Prior art]
2. Description of the Related Art Conventionally, in a medical institution such as a hospital, a dry preparation such as a powdered drug or a lyophilized drug contained in a drug container such as a vial is dissolved and used as an infusion for infusion. The operation of preparing such a dry preparation into a drug solution is to connect a container containing a drug and a container containing a dissolving solution for dissolving the drug by using a double-ended needle or a connection tool such as a connecting pipe, and dissolving the drug. This is done by transferring the liquid to a container containing the drug. However, this operation is complicated and time-consuming, and furthermore, since an operation for opening a hole for connection to a container containing the medicine is performed in the open air, the medicine in the inside may be contaminated.
In order to solve the above-mentioned problems, Japanese Patent Application Laid-Open No. 61-501129, Japanese Patent Application Laid-Open No. 2-1277, Japanese Patent Application Laid-Open No. 3-37067, and the like aiming at a complete aseptic operation, JP-A-59-209535, JP-A-62-137056, JP-A-2-4375, JP-A-60-210261, etc., which do not allow a complete aseptic operation, but are not compatible with drugs. There have been proposed ones that enable a substantially aseptic operation in which a combination of lysing solutions can be arbitrarily selected.
[0003]
Japanese Unexamined Patent Publication No. 61-501129 discloses a structure in which a capsule containing a medicine container and a flexible container containing a solution are connected by a tube, and a communication means provided in the tube. Thereby, the medicine container and the flexible container are communicated, and the medicine and the solution are aseptically mixed. Japanese Patent Application Laid-Open No. 2-1277 discloses a device in which a capsule containing a medicine container is connected to an opening of a solution container at a joint thereof, and a communication order regulating means is provided at the joint of the capsule. With the communication means interposed, the lysis solution container is pierced after the drug container is pierced by the communication means, and the two containers are communicated, so that the drug and the lysis solution are aseptically mixed. Japanese Patent Application Laid-Open No. 3-37067 discloses that a medicine container, a communicating means, and a solution container are arranged in this order, sealed with a synthetic resin sheet, and between the medicine container and the solution container. A container supporting means is interposed from above the sheet so that the two containers do not approach each other until a sterile communication / mixing operation is performed.
[0004]
On the other hand, JP-A-59-209535 discloses a sealed first flexible container having a flexible wall member, which can be fixed by penetrating through the wall member of the flexible container. A second container having a stopper to be obtained, and a stopper removal member having a portion that engages with the stopper. After the first container penetrates the second container and engages the stopper with the stopper removal member, the first container is removed. An apparatus is disclosed in which the stopper is removed from the second container together with the sealing barrier of the flexible container so that the contents of the two containers can be mixed. Japanese Patent No. 4375 discloses an improved version of the second container. Japanese Patent Application Laid-Open No. Sho 60-210261 is an improved version of the apparatus disclosed in Japanese Patent Application Laid-Open No. Sho 59-209535.
[0005]
The former device disclosed in JP-T-61-501129 and the like has a drawback that the drug to be prepared is limited to one because the drug container and the dissolution solution container are paired due to its configuration. However, the apparatus disclosed in JP-A-59-209535 and the like has a complicated mechanism and a stopper is provided in the first container. There are many drawbacks such as being dropped inside, and it is not possible to perform completely aseptic operation, but it is possible to perform substantially aseptic operation, and it is possible to arbitrarily select the combination of drug and dissolution solution In medical practice, it is necessary to properly use both as needed.
[0006]
[Problems to be solved by the invention]
The present invention has been made in view of the above-described circumstances, and can perform aseptic operation equivalent to the apparatus disclosed in the above-mentioned Japanese Patent Publication No. 61-501129, and has a simple structure and easy operation. It is another object of the present invention to provide a low-cost dissolving solution injection set that is portable and portable.
[0007]
[Means for Solving the Problems]
The present invention solves the above problems by providing Consists of multiple vertical ribs to hold the container A cylindrical capsule with a bottom provided with a container holding means, a medicine container accommodated and held upward in the capsule, and a cap member rotatably mounted on the opening of the capsule and sealing the opening of the capsule And a container carrier having a mouth and a bottom, the container carrier being accommodated and supported by the cap member, and a solution container being accommodated and held by the container carrier When , Content Communicating means held in the capsule so as to be located between the container carrier and the medicine container, and held in a vertically slidable manner by the inner wall of the capsule, and cap member removing means provided on the capsule; Guide means is provided between the container carrier and the capsule for sliding the container carrier to the drug container side without rotating the cap member when the cap member is rotated. Move in the direction of the container and connect the solution container and the drug container by communication means In addition, the medicine container, the container carrier, the dissolving solution container, and the communicating means are sealed by a capsule and a cap member that is capped at an opening of the capsule, and is portable. A solution injection set is used.
[0008]
Here, the guide means includes a plurality of parallel spiral grooves provided on the inner wall of the cap member, a plurality of vertical grooves provided on the inner wall of the capsule, and a plurality of first and second grooves provided on the outer wall of the container carrier. The first slide projection can be slidably fitted in the spiral groove, and the second slide projection can be slidably fitted in the vertical groove. Also, a through hole may be provided at the bottom of the container carrier to make it easier to remove the solution container from the container carrier, and to make it easier to remove the solution container and the drug container from the capsule, to the communication means, when the communication operation is completed. First and second engagement means are provided which engage with the mouth of the solution container and the mouth of the medicine container, respectively, and can be easily released when the two containers in the engaged state are taken out of the capsule. Is also good. In such a releasable configuration, for example, the first engagement means is constituted by a flexible engagement arm provided on the surface of the hub, and the engagement arm is engaged with the mouth of the solution container. And a second engaging means formed of a flexible engaging arm provided on the back surface of the hub, the engaging arm engaging with the mouth of the solution container. This is achieved by forming protrusions. Further, a flexible communication obstruction means for preventing the dissolution liquid container from being communicated by the communication means is provided on the engagement arm of the communication means, and the obstruction by the communication obstruction means is released after the medicine container is communicated by the communication means. The dissolving solution container may be configured to communicate with the dissolving solution container.
[0009]
[Action]
According to the above arrangement, when the cap member is rotated, for example, clockwise, the guide means operates, for example, such that the guide means includes the spiral groove of the cap member, the first and second slide protrusions of the container carrier, and the longitudinal groove of the capsule. , The first slide protrusion of the container carrier slides along the spiral groove of the cap member, but the second slide protrusion of the container carrier slides along the vertical groove of the capsule. The container carrier containing the liquid container slides toward the medicine container without rotating. At this time, communication means (for example, a double-ended needle) interposed between the solution container and the medicine container also slides together with the container carrier to reach the medicine container, and the cutting edges at both ends thereof communicate the solution solution container and the medicine container. After communication between the solution container and the drug container, the cap member is removed from the capsule, then the integrated container carrier and the drug container are taken out, and the drug solution is thoroughly mixed with the solution in the solution container and the drug in the drug container. Can be prepared. In the case of performing intravenous drip treatment, the adjusted drug solution may be transferred to, for example, the solution container side, and an infusion set or the like may be connected to the drug solution outlet.
[0010]
【Example】
Next, an embodiment of the present invention will be described with reference to the drawings.
FIG. 1 is a longitudinal sectional view of a solution injection set according to one embodiment of the present invention, FIG. 2 is a longitudinal sectional view of the medicine container shown in FIG. 1, and FIG. 3 is a longitudinal sectional view of the solution container shown in FIG. 4 is a longitudinal sectional view showing another embodiment of the solution container, FIG. 5 is a longitudinal sectional view of the communicating means (double-ended needle) shown in FIG. 1, FIG. 6 is a bottom view of FIG. 5, and FIG. 8, FIG. 8 is a longitudinal sectional view showing another embodiment of the communication means, FIG. 9 is a longitudinal sectional view of the container carrier shown in FIG. 1, FIG. 10 is a bottom view of FIG. 9, and FIG. 12 is a plan view of FIG. 11, FIG. 13 is a longitudinal sectional view of the cap shown in FIG. 1, FIG. 14 is a bottom view of FIG. 13, and FIG. 15 is a plan view of the cap removing means shown in FIG. FIG. 16 is a sectional view taken along line XX of FIG.
As shown in FIG. 1, a dissolving solution injection set of the present invention includes a bottomed cylindrical capsule 1, a medicine container 2 housed and held upward in the capsule 1, and a rotatable crown attached to the capsule 1. Cap member 3, a container carrier 4 housed and supported by the cap member 3, a dissolution liquid container 5 housed and held by the container carrier 4, and a slidable holder between the container carrier 4 and the medicine container 2. Communication means 6 to be connected. By rotating the cap member, the container carrier 4 is slid toward the medicine container 2 without rotating, so that the solution container 5 held in the container carrier 4 and the medicine container 2 are communicated by the communication means 6. I have.
[0011]
The capsule 1 is a cylindrical container with a bottom that accommodates the communication means 6 with the medicine container 2 and at least the second engagement protrusion 42 of the container carrier 4, and is usually made of polyethylene, polypropylene, polyester, polyvinyl chloride, polycarbonate, It is formed of a synthetic resin such as an ABS resin. The capsule 1 has a bottom 11 and an opening 12 as shown in FIGS. 11 to 12, and an outer wall of the opening 12 is formed with an annular projection 13 which engages with a cap member removing means 7 described later. . A plurality of vertical grooves 15 are formed on the inner wall of the capsule 1 so that a second slide protrusion 42 of the container carrier 4 described below is fitted and slid from the opening 12 toward the bottom 11 in FIG. Formed on the inner wall of the intermediate portion of the capsule 1, the engagement arm 64 of a communication means 6 (to be referred to as a double-ended needle, hereinafter, referred to as a double-ended needle) 6 slides in the vertical direction with a double-ended needle engagement. Grooves 17 are formed (four grooves are formed in FIG. 11). The double-ended needle engaging groove 17 may be partially or entirely formed integrally with the vertical groove 15 (in FIG. 11, two double-ended needle engaging grooves are formed on the extension of the vertical groove). A plurality of engagement ribs 16 are formed in the double-ended needle engagement groove 17 in the lateral direction (four are formed in FIG. 11), and the engagement ribs 16 are easily engaged with the engagement arms 64 of the double-ended needle 6. It functions so as not to move downward. The engagement rib 16 also has a function of positioning the double-ended needle 6. A plurality of vertical ribs 14 for holding the medicine container 2 in the direction of the opening 12 are formed on the bottom 11 of the capsule 1 (four in FIG. 11 are formed). Although there is no problem even with one vertical groove 15, it is preferable to form two or more in consideration of the stability of the container carrier 4.
[0012]
The capsule 1 includes a medicine container 2, a double-ended needle 6, and a container carrier 4 containing a solution container 5 therein, as shown in FIG. And the upper puncture needle 62 thereof is directed toward the opening 12 (hereinafter referred to as the upper side), and the container carrier 4 is dispensed with the lysis solution container 5 (the container carrier such that the opening 51 is on the second slide projection 42 side). 4 is accommodated with the second slide projection 42 side facing the bottom 11 side (hereinafter, referred to as the lower side) such that the mouth 51 of the second projection 4 faces the bottom 11 side.
The medicine container 2 is generally made of glass, and as shown in FIG. 2, its mouth 21 is sealed by a sealing member such as a rubber stopper 22, and the rubber stopper 22 is further formed by a caulking member 23 made of aluminum or the like. It is fastened and fixed to the mouth 21. A commercially available drug container can be used as the drug container 2, and when assembling the dissolving solution injection set, the top surface of the caulking member 23 is removed, and a through hole is formed at a position where the lower needle 6 of the double-ended needle 6 punctures. 24 are formed. Note that a dry preparation such as a powder preparation or a freeze-dried preparation is accommodated inside the medicine container 2, but is omitted in the drawing.
[0013]
The double-ended needle 6 used as the communicating means is disposed between the medicine container 2 and the solution container 5 as shown in FIG. 1, and is usually combined with stainless steel (preferably SUS104) or synthetic resin cannula. It is composed of a resin hub. When sharpness is emphasized, stainless steel cannula is preferred, but in view of the problem of disposal after use and the advantage of being able to be integrally molded, a double-ended needle made of synthetic resin is preferred. As the synthetic resin, for example, an ABS resin, high-density polyethylene, polycarbonate or the like is suitably employed.
[0014]
The double-ended needle 6 slides downward together with the container carrier 4 to penetrate the rubber stopper 22 of the mouth 21 of the medicine container 2 and further penetrates the rubber stopper 52 and the closing membrane 53 of the mouth 51 of the solution container 5 described later. As shown in FIGS. 5 to 7, a hub 61, an upper puncture needle 62 for penetrating the rubber stopper 52 of the solution container 5, and a lower part for penetrating the rubber stopper 22 of the medicine container 2, as shown in FIGS. Puncture needle 63 An engagement arm 64 is provided at the tip of the hub 61 in the vertical direction of the hub 61. The engaging arm 64 is provided at its tip with a protruding portion 641 which comes into contact with the double-ended needle engaging groove 17 of the capsule 1 and slides along the same. It is easily releasably engaged with the rib 16.
[0015]
The hub 61 of the double-ended needle 6 may be provided with a flexible communication obstructing means 65 as shown in FIG. The communication obstructing means 65 includes a bulging portion 651 that receives the mouth portion 51 of the lysing solution container 5 and hinders the downward movement of the lysing solution container 5, and a flexible leg 652. In this case, the leg 652 is bent outward to allow the mouth portion 51 of the solution container 5 to move downward. Accordingly, for example, the magnitude of the load that allows the downward movement of the mouth portion 51 of the solution container 5 is larger than the resistance of the lower end puncture needle 63 of the double-ended needle 6 to the penetration of the rubber stopper 22 of the medicine container 2. By selecting the shape of the bulging portion 653 that receives the mouth portion 51 of the solution container 5 and the thickness of the legs 652, the double-ended needle 6 pierces the rubber stopper 52 of the solution container 5 and the rubber stopper 22 of the medicine container 2. It is possible to reliably control the communication order. That is, the rubber stopper 52 of the solution container 5 can be prevented from being pierced by the upper puncture needle 62 only after the rubber stopper 22 of the medicine container 2 has been pierced by the lower puncture needle 63.
[0016]
The hub 61 of the double-ended needle 6 is engaged with the mouth 51 of the solution container 5 and the mouth 21 of the medicine container 2 when the communication operation is completed, and the two containers 2 and 5 in the engaged state are taken out of the capsule 1. An engagement means that can be easily released when the operation is performed may be provided. As such an engagement means, a configuration including a flexible leg and a hook provided inward at the tip of the leg can be adopted. FIG. 8 shows such engaging means as first engaging means 66 engaging with the mouth 51 of the solution container 5 and second engaging means engaging with the mouth 21 of the drug container 2. 67 is shown. Although the first engaging means 66 can be provided separately, it is provided in the communication blocking means 65 in the figure. That is, the leg 652 is also a leg of the first engaging means 66, and the hook is formed by making the lower surface of the bulging portion 651 on the upper puncture needle 62 be perpendicular or acute to the leg 652. The second engaging means 67 includes a flexible leg 671 and a hook 672 provided inward at the tip of the leg 671. Since these engaging means 66, 67 have flexible legs 652, 672, after taking out the connected drug container 2, double-ended needle 6, and dissolving solution container 5 from the capsule 1, hand or the like is used. Can be easily released.
[0017]
The container carrier 4 that accommodates and holds the solution container 5 and slides it toward the double-ended needle 6 is usually a cylindrical container made of the same synthetic resin as the capsule 1, as shown in FIGS. In addition, a first slide protrusion 41 that slides along a spiral groove 33 of the cap member 3 described later is provided on a bottom portion, and a second slide protrusion 42 that slides along the vertical groove 15 of the capsule 1 is provided at a mouth portion. Is provided. A plurality of slits 43 are formed at the mouth to facilitate insertion of the solution container 5, and a through hole 44 is formed at the bottom to facilitate removal of the solution container 5 if necessary. The first slide projection 41 and the second slide projection 42 cooperate with the vertical groove 15 of the capsule 1 and a spiral groove 33 of the cap member 3 described later to change the rotational movement of the cap member 3 into a linear movement, Guide means for sliding the carrier 4 straight toward the double-ended needle 6 and the medicine container 2 is constituted. That is, in the case of the cap member 3 as shown in FIG. 13, when the cap member 3 is rotated clockwise, the first slide protrusion 41 of the container carrier 4 is fitted into the spiral groove 33 of the cap member 3. The container carrier 4 tends to rotate with the cap member 3. However, since the second slide projection 42 of the container carrier 4 is fitted into the vertical groove 15 of the capsule 1, the container carrier 4 cannot rotate, and the first slide projection 41 becomes the spiral groove 33 of the cap member 3. To move the container carrier 4 downward. It is preferable that a plurality of the first slide protrusions 41 and the second slide protrusions 42 are provided (two are provided in FIG. 9), but one may be functionally provided.
[0018]
The solution container 5 accommodated in the container carrier 4 is a press-deformable container whose container main body 55 is generally formed of a relatively soft synthetic resin such as polyethylene, polypropylene, or polyester, and is usually as shown in FIG. A device having an opening 51 that also serves as a communication port and a drug solution take-out port is employed. The mouth portion 51 shown in FIG. 3 is formed by welding a closure member composed of a rubber stopper 52 and a pressing member 54 on a closure film 53 of a container body 55, and prevents elution from the rubber stopper 52 into the solution. It has a structure that can be used. As shown in FIG. 4, the solution container 5 may be provided with a chemical solution outlet 561 independently of the mouth 51, and the mouth 51 may be used as a communication port. In this case, the structure of the chemical solution take-out port 561 can be the same as that of the mouth section 51, and can be constituted by the closing film 563, the rubber stopper 562, and the pressing member 564. It is preferable to protect the rubber stopper 562 which has a high risk of being clogged with a cover sheet 57 such as a synthetic resin film.
[0019]
The cap member 3 and the cap member removing means 7 are attached to the opening 12 of the capsule 1 in which the medicine container 2, the communication means (double-ended needle) 6 and the solution container 5 are accommodated in this order. The cap member removing means 7 can be configured so as to be attached from above the cap member 3 attached to the opening 12 of the capsule 1, but in such a configuration, the cap member 3 is removed and the inside of the medicine container 2 and the dissolution medium are dissolved. Since the liquid container 5 can be replaced (so-called tampering), in FIG. 1, the cap member removing means 7 is attached to the opening 12 of the capsule 1 as a preferable structure, and the cap member 3 is forcibly fitted thereon (so-called impossible). (Fitting) configuration.
[0020]
The cap member 3 shown in FIGS. 13 and 14 is a cap member 3 having a falsification preventing function, and is used in combination with the cap member removing means 7 shown in FIGS. The cap member 3 includes a top surface 31 and a skirt portion 32. The cap member 3 is usually formed in a cylindrical shape with the same synthetic resin as the container carrier 4, and the cap member 3 and the capsule 1 are provided at the lower end of the skirt portion 32 as a side wall. A seal member mounting groove 36 for mounting a seal member 8 for hermetically sealing the space is formed. As shown in FIG. 13, a spiral groove 33 that engages with the first slide projection 41 of the container carrier 4 is formed on the inner wall of the skirt portion 32, which is the side wall, and the lower end inner wall of the skirt portion 32 is formed. Is provided with a projection 35 rotatably fitted into a groove 72 of a cap member removing means 7 described later. The spiral groove 33 can be formed by cutting the inner wall of the skirt portion 32, but may be formed by providing a spiral ridge 34 as shown in FIG.
[0021]
The cap member removing means 7 removes the cap member 3 from the capsule 1 so that the medicine container 2, the double-ended needle 6, and the solution container 5 can be taken out, and is formed in a ring shape as shown in FIGS. . The cap member removing means 7 has on its inner wall an annular projection 71 which rotatably engages with the annular projection 13 of the opening 12 of the capsule 1, and has on its outer wall a projection 35 on the inner wall at the lower end of the cap member 3. And a groove 72 which is rotatably engaged with the groove 72 is formed. The groove 72 is formed intermittently, and the portion of the groove cut 73 is formed in a shape in which the upper side wall portion forming the groove 73 is cut out, that is, a stepped shape. The length is shorter than the length of the cut 73 of the groove. A locking projection 74 is provided between the groove 72 facing clockwise and the cut 73 of the groove. When the cap member 3 is turned clockwise, the projection 35 of the cap member 3 So that the cap member removing means 7 rotates together with the cap member 3 by colliding with the locking projection 74. Has become . Then, while the cap member removing means 7 is rotating together with the cap member 3, the projection 35 of the cap member 3 is in the groove 72 of the cap member removing means 7, and then the cap member 3 is turned counterclockwise. Then, the projection 35 comes to the cut 73 of the groove. In this case, since the protrusion 35 is formed shorter than the groove cut 73, when the cap member 3 is moved upward when the protrusion 35 comes to the groove cut 73, the cap member 3 is moved from the cap member removing means 7. It has come off.
[0022]
Here, since the cap member removing means 7 is almost covered with the lower end of the skirt portion 32 of the cap member 3 as shown in FIG. 1, it is impossible to turn only the cap member removing means 7 by hand. is there. Therefore, when the cap member 3 is removed, that is, when the cap member 3 is rotated counterclockwise, the cap member removing means 7 rotates on the inner wall at the upper end so that the cap member removing means 7 does not rotate together with the cap member 3. A prevention projection 75 is provided to engage with a ridge 18 provided on the outer wall of the opening 12 of the capsule 1. Then, only when the cap member 3 is turned clockwise to connect the medicine container 2 and the solution container 5 with the double-ended needle 6, the ridge 18 of the capsule 1 just passes over the rotation preventing projection 75. The cap member 3 cannot be removed from the capsule 1 unless the communication operation is completed.
[0023]
In FIGS. 15 and 16, the cap member removing mechanism including the groove 72, the groove cut 73, and the locking projection 74 is formed on the outer wall of the cap member removing means 7. 7 may be combined with a projection (not shown, but equivalent to the projection 35) formed on the outer wall at the lower end of the skirt portion 32 of the cap member 3. Further, a mechanism similar to the cap member removing mechanism is provided on the inner wall or the outer wall of the cap member 3, and is combined with a projection (not shown) similar to the projection 35 of the cap member 3 provided on the outer wall of the cap member removing means 7. It may be. However, the cap member 3 cannot be rotated in a counterclockwise direction before use because the spiral groove 33 and the first slide protrusion of the container carrier 4 are engaged with each other. In the case where a cap member removing mechanism or a projection is provided on the outer wall, the cap member 3 can be taken out by turning only the cap member removing means 7 in a counterclockwise direction. It is necessary to provide a means to prevent such a situation.
[0024]
Next, the use of the dissolving solution injection set of the present invention will be described with reference to FIG.
When the cap member 3 is turned clockwise, the first slide protrusion 41 of the container carrier 4 slides along the spiral groove 33 of the cap member 3, but the second slide protrusion 42 of the container carrier 4 moves vertically of the capsule 1. Because of the sliding along the groove 15, the container carrier 4 containing the solution container 5 slides toward the medicine container 2 without rotating. When the mouth 51 of the solution container 5 collides with the communication obstruction means 65 of the communication means (double-ended needle 6) interposed between the dissolution liquid container 5 and the medicine container 2, the double-ended needle 6 also slides together with the container carrier 4. To reach the medicine container 2, and the lower puncture needle 63 pierces the rubber stopper 22 of the medicine container 2. At the position where the lower puncture needle 63 completes the penetration of the rubber stopper 22 of the medicine container 2, the hub 61 of the double-ended needle 6 collides with the mouth 21 of the medicine container 2 and the downward movement of the double-ended needle 6 is prevented. . At this time, the load applied to the communication obstruction means 65 of the double-ended needle 6 by the mouth 51 of the solution container 5 becomes large, so that the legs 652 of the communication obstruction means 65 are bent outward, and the mouth 51 is closed by the communication obstruction means 65. It comes off from the bulge 651. Then, the solution container 5 moves downward, and the rubber stopper 52 of the mouth portion 51 is pierced by the upper puncture needle 62. Thus, the medicine container 2 and the solution container 5 are communicated via the double-ended needle 6. After the communication between the solution container 5 and the drug container 2, the engagement between the cap member removing means 7 and the cap member 3 can be easily released by turning the cap member 3 counterclockwise. The engagement between the cap member removing means 7 and the cap member 3 is released, the cap member 3 is removed from the capsule 1, and then the integrated container carrier 4, double-ended needle 6 and drug container 2 are taken out, and the solution container 5 is removed. The solution can be prepared by transferring the solution into the medicine container 2 through the medicine passage 68 of the double-ended needle 6 and mixing the solution with the medicine in the medicine container 2 well. In the case of performing infusion therapy, the adjusted drug solution may be transferred to, for example, the solution container 5 and an infusion set or the like may be connected to the drug solution outlet.
Further, if a spray nozzle is attached to the mouth 21 of the medicine container 2, it can be used as a spray liquid.
The transfer and mixing operations of the dissolving solution can, of course, be performed in a state of being accommodated in the capsule 1. In addition, a spray nozzle can be attached to the dissolution liquid container 5 in advance instead of the chemical liquid outlet 561.
[0025]
【The invention's effect】
As is clear from the above description, the following effects can be obtained by employing the solution injection set of the present invention.
{Circle around (1)} Since aseptic operation is possible, infection due to contamination of bacteria can be prevented.
{Circle around (2)} Since the operation is easy, labor of the operation can be saved, labor costs can be saved, and labor shortage can be dealt with.
(3) It is possible to regulate the communication order by providing the communication obstruction means. In this case, there is no fear of an erroneous operation, so that the operation can be performed by the patient himself and can be adopted as a home care product.
(4) A solution injection set can be provided at low cost.
(5) Since the communication mechanism between the medicine container and the solution container is housed in the capsule, there is no fear of breakage, and the device can be carried around.
[Brief description of the drawings]
FIG. 1 is a longitudinal sectional view of a dissolving solution injection set according to one embodiment of the present invention.
FIG. 2 is a longitudinal sectional view of the medicine container shown in FIG.
FIG. 3 is a longitudinal sectional view of the solution container shown in FIG.
FIG. 4 is a longitudinal sectional view showing another embodiment of the solution container.
FIG. 5 is a longitudinal sectional view of the communication means (double-ended needle) shown in FIG. 1;
FIG. 6 is a bottom view of FIG. 5;
FIG. 7 is a plan view of FIG. 5;
FIG. 8 is a longitudinal sectional view showing another embodiment of the communication means.
9 is a longitudinal sectional view of the container carrier shown in FIG.
FIG. 10 is a bottom view of FIG. 9;
11 is a longitudinal sectional view of the capsule shown in FIG.
FIG. 12 is a plan view of FIG. 11;
FIG. 13 is a longitudinal sectional view of the cap shown in FIG. 1;
FIG. 14 is a bottom view of FIG.
FIG. 15 is a plan view of the cap removing means shown in FIG. 1;
16 is a sectional view taken along line XX of FIG.
[Explanation of symbols]
1 capsule
13 annular projection
14 vertical ribs
15 flute
16 Engagement rib
17 Double-ended needle engagement groove
18 Ridge
2 medicine container
3 Cap member
33 spiral groove
35 protrusion
36 Seal member mounting groove
4 Container carrier
41 1st slide projection
42 Second slide projection
5 Dissolution liquid container
57 cover sheet
6. Double-ended needle (communication means)
62 Upper puncture needle
63 Lower puncture needle
64 engagement arm
65 Means of Communication Disturbance
66 First engagement means
67 Second engagement means
7 Cap member removal means
72 grooves
73 Groove Break
74 locking projection
75 Rotation prevention protrusion
8 Seal members

Claims

A bottomed cylindrical capsule provided with a container holding means comprising a plurality of vertical ribs for holding the container on its inner wall, a drug container held and held upward by the capsule, A cap member movably mounted on the capsule to seal the opening of the capsule, a container having a mouth and a bottom, the container carrier being accommodated and supported by the cap member, and a dissolving being accommodated and held by the container carrier A liquid container, communicating means accommodated in the capsule so as to be located between the container carrier and the drug container, and held vertically slidably by the inner wall of the capsule; and cap member removing means provided on the capsule. When the cap member is rotated between the cap member, the container carrier and the capsule, the container carrier slides toward the drug container without rotating the container carrier. Providing guide means for moving the dissolving solution container together with the container carrier in the direction of the medicine container by rotating the cap member, communicating the dissolving solution container and the medicine container by the communicating means, and connecting the medicine container and the container carrier with each other. A portable dissolving solution injection set, wherein the dissolving solution container and the communicating means are sealed by a capsule and a cap member capped at an opening of the capsule.

The guide means includes a plurality of parallel spiral grooves provided on the inner wall of the cap member, a plurality of vertical grooves provided on the inner wall of the capsule, and a plurality of first and second slides provided on the outer wall of the container carrier. The dissolving solution injection set according to claim 1, comprising a projection, wherein the first slide projection is slidably fitted in the spiral groove, and the second slide projection is slidably fitted in the vertical groove.

The dissolving solution injection set according to claim 1 or 2, wherein a through hole is provided in a bottom portion of the container carrier.

The first and the second communication means are engaged with the mouth of the solution container and the mouth of the medicine container when the communication operation is completed, and can be easily released when the two containers in the engaged state are taken out of the capsule. The dissolving solution injection set according to any one of claims 1 to 3, further comprising a second engaging means.

The first engaging means is constituted by a flexible engaging arm provided on the surface of the hub, and the engaging arm is formed with an engaging projection for engaging with the mouth of the solution container. 5. The dissolving solution according to claim 4, wherein the engaging means is constituted by a flexible engaging arm provided on the back surface of the hub, and the engaging arm is formed with an engaging projection for engaging with the mouth of the dissolving solution container. Infusion set.

A flexible communication obstruction means for preventing the dissolution liquid container from being communicated by the communication means to the engagement arm of the communication means is provided, and the obstruction by the communication obstruction means is released after the medicine container is communicated by the communication means, The dissolving solution injection set according to claim 5, wherein the dissolving solution container is connected to the dissolving solution container.