JP6255163B2

JP6255163B2 - Drug preparation tool

Info

Publication number: JP6255163B2
Application number: JP2013079585A
Authority: JP
Inventors: 智行北條; 愛子堀内; 理恵小川; 義久森山; 鈴木　茂; 鈴木　　茂; 大野　達也; 達也大野
Original assignee: TRUMO KABUSHIKI KAISHA
Current assignee: TRUMO KABUSHIKI KAISHA
Priority date: 2013-04-05
Filing date: 2013-04-05
Publication date: 2017-12-27
Anticipated expiration: 2033-04-05
Also published as: JP2014200505A

Description

本発明は、薬剤調製用具に関する。 The present invention relates to a drug preparation device.

プレフィルドシリンジとしては、薬液、薬剤溶解液などの医療用液体が充填された状態にて提供される。薬剤溶解液充填プレフィルドシリンジは、凍結乾燥製剤などの用時溶解が必要な粉末製剤を投与する際に用いられる。粉末製剤が収納された薬剤容器（バイアル）に、薬剤溶解液充填プレフィルドシリンジを接続し、シリンジ内の溶解液を薬剤容器に注入し、容器内の粉末製剤を溶解液に溶解させた後、シリンジ内に吸引することにより、投与可能となる。また、希釈液充填プレフィルドシリンジは、濃縮薬剤が収納された薬剤容器に、希釈液充填プレフィルドシリンジを接続し、シリンジ内の希釈液を薬剤容器に注入し、容器内の濃縮製剤を希釈液で希釈させた後、シリンジ内に吸引することにより、投与可能となる。 As a prefilled syringe, it is provided in the state with which medical liquids, such as a chemical | medical solution and a chemical | medical agent solution, were filled. The drug solution-filled prefilled syringe is used when administering a powder preparation that needs to be dissolved at the time of use, such as a freeze-dried preparation. A prefilled syringe filled with a drug solution is connected to a drug container (vial) containing a powder formulation, the solution in the syringe is injected into the drug container, and the powder formulation in the container is dissolved in the solution, then the syringe It becomes possible to administer by aspirating the inside. In addition, the diluent-filled prefilled syringe connects the diluent-filled prefilled syringe to the drug container containing the concentrated drug, injects the diluent in the syringe into the drug container, and dilutes the concentrated formulation in the container with the diluent. Then, it can be administered by aspiration into a syringe.

これらのプレフィルドシリンジの薬剤容器への接続は、金属針を用いるのが一般的であるが、最近では、専用のコネクターを用いる製品も提案されている。粉末製剤では、調製段階において、溶解するために用意した溶媒入りシリンジに、すでに薬剤を溶解したと思い込んでしまうおそれがある。また逆に、既に粉末製剤を溶解した薬液にさらに粉末製剤を溶解するというおそれがある。また、一般的に液体薬剤は無色透明であるため、濃縮製剤と希釈された製剤では視覚によって識別不可能である。このため、希釈液のみを投与して、薬剤投与が行われないおそれがある。 A metal needle is generally used to connect these prefilled syringes to a drug container, but recently, a product using a dedicated connector has also been proposed. In the case of a powder formulation, there is a possibility that it is assumed that the drug is already dissolved in a syringe containing a solvent prepared for dissolution in the preparation stage. Conversely, there is a risk that the powder formulation is further dissolved in the chemical solution in which the powder formulation has already been dissolved. Moreover, since a liquid medicine is generally colorless and transparent, it cannot be visually discriminated between a concentrated preparation and a diluted preparation. For this reason, there exists a possibility that only a diluent may be administered and drug administration may not be performed.

特許第４２１６４６６号公報（特許文献１）には、以下のものが開示されている。特許文献１の移転セット２０は、特許文献１の図１に示されているように、チューブ状移転部材４６と、該チューブ状移転部材に往復動可能に支持されている中央突き刺し部材４８と、このアセンブリを覆って密閉するカップ状のキャップ５０と、この移転セットを薬剤容器に固定するカラー部材５２とを含む四つの構成部品からなっている。特許文献１の図１及び２に示されているように、チューブ状部材４６の基端は、好ましくは図２に示されているような、鋭い先端縁５６を備えた円形又は環状のシールリップ５４を備えている。このチューブ状移転部材４６の基端は、以下に述べるキャップ５０の同心シールリップ８６等の複数のシールリップを備えていることが判る。開示されている実施例においては、チューブ状移転部材４６は、更に、以下に詳述する図２に示されている半径方向のコネクター部分５８を備えている。ルアーロック (Luer lock)６０のようなコネクターが、チューブ状移転部材の開放末端６２に隣接して設けられている。 Japanese Patent No. 4216466 (Patent Document 1) discloses the following. As shown in FIG. 1 of Patent Document 1, the transfer set 20 of Patent Document 1 includes a tube-shaped transfer member 46 and a central piercing member 48 supported by the tube-shaped transfer member so as to reciprocate. It consists of four components, including a cup-shaped cap 50 that covers and seals the assembly, and a collar member 52 that secures the transfer set to the drug container. As shown in FIGS. 1 and 2 of U.S. Pat. No. 6,053,086, the proximal end of the tubular member 46 is preferably a circular or annular sealing lip with a sharp tip edge 56, as shown in FIG. 54. It can be seen that the proximal end of the tubular transfer member 46 includes a plurality of seal lips such as a concentric seal lip 86 of the cap 50 described below. In the disclosed embodiment, the tubular transfer member 46 further comprises a radial connector portion 58 shown in FIG. A connector, such as a Luer lock 60, is provided adjacent the open end 62 of the tubular transfer member.

なお、特許文献１の薬剤容器移転セットすなわち流体移転アセンブリは、注射器や静脈注射用（ＩＶ）装置等と密閉された薬剤容器との間に流体的連通を確立するように構成されている。注射器と薬剤容器とは従来型のものであり、ＩＳＯ標準によって製造されている。このため、チューブ状本体部分１１２のカラー部分すなわちチューブ状延長部１２９はノズル１１４の末端部分を越えて延び、その内面は針を注射器に接続するのに通常使用されている雌型のルアーロック又は雌型のねじ山を備えている。 Note that the drug container transfer set or fluid transfer assembly of Patent Document 1 is configured to establish fluid communication between a syringe, an intravenous (IV) device, and the like and a sealed drug container. The syringe and drug container are conventional and are manufactured to ISO standards. For this reason, the collar portion or tubular extension 129 of the tubular body portion 112 extends beyond the distal portion of the nozzle 114 and its inner surface is a female luer lock or commonly used to connect a needle to a syringe. It has a female thread.

また、本件出願人は、特開２０１１−７２４４０号公報（特許文献２）を提案している。
特許文献２の薬剤容器装着済み薬剤投与具１は、ＩＳＯ規格に適合しないノズル部３５を備えるプレフィルドシリンジ３と、薬剤を収納した薬剤容器４と、薬剤容器に装着されたアダプター２とからなる。アダプターは、ＩＳＯ規格に適合した医療用具接続部７２とシリンジ３のノズル部との接続部とを備えるコネクター７と、中空針状部６２とコネクター装着部６１とカラー部６３とを備える穿刺部材６と、薬剤容器装着部５１と中空針状部収納用筒状部５４とを有するガイド部材５とからなる。穿刺部材とガイド部材は、穿刺部材による薬剤容器のシール部材４２への刺通完了後に係合し、穿刺部材のガイド部材からの離脱を抑制する係合部を備えている。 Further, the present applicant has proposed Japanese Patent Application Laid-Open No. 2011-72440 (Patent Document 2).
The drug administration device 1 with a drug container mounted in Patent Document 2 includes a prefilled syringe 3 having a nozzle portion 35 that does not conform to the ISO standard, a drug container 4 containing a drug, and an adapter 2 mounted on the drug container. The adapter includes a connector 7 including a medical device connection portion 72 conforming to the ISO standard and a connection portion between the nozzle portion of the syringe 3, a puncture member 6 including a hollow needle-like portion 62, a connector mounting portion 61, and a collar portion 63. And a guide member 5 having a medicine container mounting portion 51 and a hollow needle-like portion storage tubular portion 54. The puncture member and the guide member are provided with an engagement portion that is engaged after the puncture member completes the puncture of the drug container to the seal member 42 and prevents the puncture member from being detached from the guide member.

特許第４２１６４６６号公報Japanese Patent No. 4216466 特開２０１１−７２４４０号公報JP 2011-72440 A

特許文献１のものでは、注射器は、ＩＳＯ標準によって製造され、ノズルは、針を注射器に接続するのに通常使用されている雌型のルアーロック又は雌型のねじ山を備えているため、注射器内に薬剤溶解液が充填されている場合、溶解液のみの誤投与を起こす可能性がある。
特許文献２のものでは、ＩＳＯ標準のノズルを持たないため、注射器内に薬剤溶解液が充填されている場合、溶解液のみの誤投与を起こす可能性が極めて少なく、有効である。しかし、特許文献２のものでは、薬液投与準備作業が、若干煩雑であった。
本発明の目的は、プレフィルドシリンジ内に充填された医療用液体のみが投与されることを防止し、かつ、薬剤投与準備も容易である薬剤調製用具を提供するものである。 In US Pat. No. 6,099,056, the syringe is manufactured according to ISO standards and the nozzle is provided with a female luer lock or female thread that is commonly used to connect the needle to the syringe. If the drug solution is filled inside, there is a possibility of misadministration of only the solution.
In the case of Patent Document 2, since there is no ISO standard nozzle, there is very little possibility of erroneous administration of only the solution when the drug solution is filled in the syringe, which is effective. However, in the thing of patent document 2, the chemical | medical solution administration preparation work was a little complicated.
An object of the present invention is to provide a drug preparation device that prevents only a medical liquid filled in a prefilled syringe from being administered and that is easy to prepare for drug administration.

上記目的を達成するものは、以下のものである。
（１）ＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なオス型接続部であるノズル部を先端部に備えるシリンジ用外筒と、前記外筒内に収納された摺動可能なガスケットと、前記ガスケットの基端に取り付けられたもしくは取付可能なプランジャと、前記外筒の前記先端部に着脱可能に装着されたアダプタと、前記外筒内に充填された医療用液体とを備えるプレフィルドシリンジと、先端が開口した筒先部を有する薬剤容器と、前記筒先部と連通する前記薬剤容器内に収納された薬剤とを備える薬剤収納済薬剤容器とからなる薬剤調製用具であって、前記アダプタは、一端より他端まで貫通した筒状体であり、一端側に、前記外筒の前記先端部に液密に接続可能な外筒接続部を備え、他端側に、前記薬剤容器の前記筒先部に液密に接続可能であり、かつ、前記メス型接続部との接続が不能な薬剤容器接続部と、前記一端より前記他端まで貫通した内腔と、前記内腔と連通した前記外筒接続部側の開口部と、前記内腔と連通した前記薬剤容器接続部側の開口部とを備え、前記薬剤調製用具は、前記アダプタの前記薬剤容器接続部側の開口部に装着され、前記薬剤容器接続部側の開口部を液密に封止する外筒封止部材を備え、前記薬剤調製用具が未使用な状態において、前記外筒の前記先端部には前記アダプタが装着されており、かつ、前記アダプタに装着された前記外筒封止部材により、前記薬剤容器接続部側の開口部が液密に封止されており、前記アダプタは、前記外筒に装着され、かつ、前記封止部材が取り外された状態において、前記外筒の前記ノズル部の前記メス型接続部への接続を阻害し、前記アダプタが装着された前記外筒は、前記薬剤容器の前記筒先部に、前記アダプタの前記薬剤容器接続部を用いて接続可能であり、前記アダプタの前記薬剤容器接続部を用いた接続により、前記外筒と前記薬剤容器の前記筒先部は連通し、前記薬剤の前記外筒への流入を許容し、かつ、接続後、前記薬剤容器は、前記アダプタとともに前記外筒より離脱可能であり、前記アダプタの離脱により、前記外筒の前記ノズル部が露出し、前記ノズル部が前記メス型接続部に接続可能となる薬剤調製用具。 What achieves the above object is as follows.
(1) Syringe outer cylinder having a nozzle part at the tip, which is a male connection part connectable to a female connection part having a female luer taper conforming to the ISO standard, and a slide housed in the outer cylinder Gasket, a plunger attached to or attachable to the proximal end of the gasket, an adapter detachably attached to the distal end of the outer cylinder, and a medical fluid filled in the outer cylinder A medicine preparation tool comprising: a prefilled syringe comprising: a medicine container having a tube tip portion having an open tip; and a medicine container containing a medicine housed in the medicine container communicating with the tube tip portion. The adapter is a cylindrical body that penetrates from one end to the other end, and is provided with an outer cylinder connecting portion that can be liquid-tightly connected to the distal end portion of the outer cylinder on one end side, and the medicine on the other end side. In front of the container A medicine container connecting portion that can be liquid-tightly connected to the recording tube tip and cannot be connected to the female connection portion, a lumen that penetrates from the one end to the other end , and communicated with the lumen An opening on the outer tube connecting part side and an opening on the drug container connecting part side communicating with the lumen, and the medicine preparation tool is mounted on the opening on the drug container connecting part side of the adapter And an outer cylinder sealing member that liquid-tightly seals the opening on the drug container connection portion side, and the adapter is attached to the distal end of the outer cylinder when the drug preparation tool is not used. The opening on the drug container connecting part side is liquid-tightly sealed by the outer cylinder sealing member attached to the adapter, and the adapter is attached to the outer cylinder , and, in a state in which the sealing member is removed, the said outer cylinder Bruno The outer cylinder to which the adapter is attached can be connected to the cylinder tip of the drug container using the drug container connection part of the adapter. The connection of the adapter using the drug container connection portion allows the outer cylinder and the cylinder tip of the drug container to communicate with each other, permit the drug to flow into the outer cylinder, and after the connection, the drug The container is detachable from the outer cylinder together with the adapter, and by removing the adapter, the nozzle part of the outer cylinder is exposed, and the nozzle part can be connected to the female connection part.

（２）前記外筒は、外筒側螺合部を備え、前記アダプタの前記外筒接続部は、前記外筒側螺合部と螺合可能なアダプタ側螺合部を備えている上記（１）に記載の薬剤調製用具。
（３）前記アダプタは、前記アダプタの内面に設けられ、前記外筒の前記ノズル部の外面と液密状態にて接触する環状リブを備えている上記（１）または（２）に記載の薬剤調製用具。
（４）前記薬剤容器と前記アダプタは、前記薬剤容器にて付与した回転力を前記アダプタに伝達可能な回転力伝達機構を備えている上記（１）ないし（３）のいずれかに記載の薬剤調製用具。
（５）前記薬剤容器と前記アダプタは、前記薬剤容器の前記アダプタへの接続後において、前記アダプタからの前記薬剤容器の分離を規制する分離規制機構を備えている上記（１）ないし（４）のいずれかに記載の薬剤調製用具。
（６）前記薬剤容器の前記筒先部の先端部は、前記アダプタの前記薬剤容器接続部内に進入可能であり、前記アダプタは、前記アダプタの内面に設けられ、前記薬剤容器の前記筒先部の外面と液密状態にて接触可能な環状リブを備えている上記（１）ないし（５）のいずれかに記載の薬剤調製用具。
（７）前記外筒と前記アダプタは、前記アダプタの前記外筒からの離脱を規制する離脱規制機構を備えている上記（１）ないし（６）のいずれかに記載の薬剤調製用具。
（８）前記アダプタの前記薬剤容器接続部は、前記メス型接続部との接続が不能である上記（１）ないし（７）のいずれかに記載の薬剤調製用具。
また、上記目的を達成するものは、以下のものである。
（９）ＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なオス型接続部であるノズル部を先端部に備えるシリンジ用外筒と、前記外筒の前記先端部に着脱可能に装着されたアダプタと、先端が開口した筒先部を有する薬剤容器と、前記筒先部と連通する前記薬剤容器の内部に収納された薬剤とからなる薬剤調製用具の使用方法であって、前記アダプタは、一端より他端まで貫通した筒状体であり、一端側に、前記外筒の前記先端部に液密に接続可能な外筒接続部を備え、他端側に、前記薬剤容器の前記筒先部に液密に接続可能であり、かつ、前記メス型接続部との接続が不能な薬剤容器接続部を備え、前記アダプタは、前記外筒に装着された状態において、前記外筒の前記ノズル部の前記メス型接続部への接続を阻害し、かつ、前記薬剤容器接続部と前記薬剤容器の前記筒先部とを接続することにより、前記薬剤容器とともに前記外筒より離脱可能であり、内部に医療用液体が充填され、かつ、ガスケットが収納され、さらに、前記薬剤容器と未接続の前記アダプタが前記外筒接続部を介して前記先端部に装着された前記外筒を準備し、前記外筒に装着された前記アダプタの前記薬剤容器接続部に、前記薬剤容器の前記筒先部を接続し、前記アダプタの前記薬剤容器接続部を用いた接続により、前記外筒と前記薬剤容器の前記筒先部を連通させ、前記薬剤を前記薬剤容器から前記外筒内に流入させて、前記薬剤を前記医療用液体に溶解または混合し、前記医療用液体に溶解または混合された前記薬剤を収納した前記外筒より前記アダプタを前記薬剤容器とともに離脱させて、前記外筒の前記ノズル部を露出させる薬剤調製用具の使用方法。 ( 2 ) The said outer cylinder is provided with the outer cylinder side screwing part, The said outer cylinder connection part of the said adapter is provided with the adapter side screwing part which can be screwed with the said outer cylinder side screwing part. A drug preparation tool according to 1).
( 3 ) The adapter according to (1) or (2) , wherein the adapter is provided on an inner surface of the adapter and includes an annular rib that is in liquid-tight contact with the outer surface of the nozzle portion of the outer cylinder. Preparation tool.
( 4 ) The medicine according to any one of (1) to ( 3 ), wherein the medicine container and the adapter include a rotational force transmission mechanism capable of transmitting the rotational force applied by the medicine container to the adapter. Preparation tool.
( 5 ) The above (1) to ( 4 ), wherein the drug container and the adapter include a separation regulating mechanism that regulates separation of the drug container from the adapter after the drug container is connected to the adapter. A drug preparation tool according to any of the above
( 6 ) The tip of the tube tip of the drug container can enter the drug container connecting portion of the adapter, and the adapter is provided on the inner surface of the adapter, and the outer surface of the tube tip of the drug container The pharmaceutical preparation device according to any one of (1) to ( 5 ), further comprising an annular rib capable of contacting with a liquid-tight state.
( 7 ) The medicine preparation tool according to any one of (1) to ( 6 ), wherein the outer cylinder and the adapter include a separation regulating mechanism that regulates separation of the adapter from the outer cylinder.
( 8 ) The drug preparation device according to any one of (1) to ( 7 ), wherein the drug container connection portion of the adapter is not connectable to the female connection portion.
Moreover, what achieves the said objective is as follows.
(9) Syringe outer cylinder with a nozzle part that is a male connection part that can be connected to a female connection part having a female luer taper conforming to the ISO standard, and detachable from the distal end part of the outer cylinder A method for using a medicine preparation tool comprising: an adapter mounted on a medicine container; a medicine container having a tube tip portion opened at a tip; and a medicine housed in the medicine container communicating with the tube tip portion. Is a cylindrical body penetrating from one end to the other end, provided on one end side with an outer cylinder connecting portion that can be liquid-tightly connected to the distal end portion of the outer cylinder, and on the other end side, the drug container A drug container connecting portion that can be liquid-tightly connected to the tube tip portion and cannot be connected to the female connection portion, and the adapter is attached to the outer tube, Prevents the nozzle from connecting to the female connection. And by connecting the medicine container connecting portion and the tube tip of the medicine container, the medicine container can be detached from the outer cylinder, filled with medical liquid, and a gasket is provided. The adapter that is stored and further connected to the distal end portion of the adapter that is not connected to the drug container via the outer tube connection portion is prepared, and the drug container of the adapter that is mounted on the outer tube The tube portion of the drug container is connected to a connection portion, and the outer tube and the tube tip portion of the drug container are communicated with each other by connection using the drug container connection portion of the adapter, and the drug is stored in the drug container. And the medicine is dissolved or mixed in the medical liquid, and the adapter is connected to the medicine container from the outer cylinder containing the medicine dissolved or mixed in the medical liquid. By leaving to be, the use of pharmaceutical preparations tool to expose the nozzle portion of the outer cylinder.

本発明の薬剤調製用具では、外筒の先端部に設けられたノズル部には、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部へのノズル部接続を阻害するアダプタが装着されている。よって、外筒内（プレフィルドシリンジ内）の医療用液体が直接投与されることがない。そして、アダプタが装着された外筒は、薬剤容器の筒先部に、アダプタの薬剤容器接続部を用いて薬剤容器に容易に接続可能である。そして、接続後、薬剤調製用具を操作することにより、薬剤容器内の薬剤の外筒内への移送を行うことができる。さらに、薬剤移送操作終了後に、外筒から、アダプタとともに薬剤容器が離脱することにより、外筒のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なノズル部が露出し、他の医療用具のＩＳＯ規格に適合したメス型接続部との接続が可能となる。このため、薬剤投与準備作業を容易に行うことができる。 In the drug preparation device of the present invention, an adapter that inhibits connection of the nozzle portion to the female connection portion having a female luer taper that conforms to the ISO standard of other medical devices is provided in the nozzle portion provided at the distal end portion of the outer cylinder. Is installed. Therefore, the medical liquid in the outer cylinder (in the prefilled syringe) is not directly administered. And the outer cylinder with which the adapter was mounted | worn can be easily connected to a chemical | medical agent container to the cylinder tip part of a chemical | medical agent container using the chemical | medical agent container connection part of an adapter. After the connection, the medicine in the medicine container can be transferred into the outer cylinder by operating the medicine preparation tool. Further, after the medicine transfer operation is completed, the medicine container is detached from the outer cylinder together with the adapter, so that the nozzle part that can be connected to the female connection part having the female luer taper conforming to the ISO standard of the outer cylinder is exposed. It is possible to connect to a female connector that conforms to the ISO standard of medical devices. For this reason, the medicine administration preparation work can be easily performed.

図１は、プレフィルドシリンジおよび薬剤収納済薬剤容器を用いた本発明の一実施例の薬剤調製用具の外観図である。FIG. 1 is an external view of a medicine preparation tool according to an embodiment of the present invention using a prefilled syringe and a medicine container with medicine contained therein. 図２は、図１に示した本発明の薬剤調製用具より、薬剤容器封止部材および外筒封止部材を離脱した状態の外観図である。FIG. 2 is an external view of a state in which the medicine container sealing member and the outer cylinder sealing member are detached from the medicine preparation tool of the present invention shown in FIG. 図３は、本発明の薬剤調製用具に使用される薬剤収納済薬剤容器の拡大縦断面図である。FIG. 3 is an enlarged longitudinal sectional view of a medicine container in which medicine is used for the medicine preparation tool of the present invention. 図４は、図３のＡ−Ａ線断面図である。4 is a cross-sectional view taken along line AA in FIG. 図５は、本発明の薬剤調製用具に使用されるプレフィルドシリンジの拡大縦断面図である。FIG. 5 is an enlarged longitudinal sectional view of a prefilled syringe used in the drug preparation device of the present invention. 図６は、図５に示したプレフィルドシリンジに用いられているアダプタの拡大正面図である。FIG. 6 is an enlarged front view of an adapter used in the prefilled syringe shown in FIG. 図７は、図６に示したアダプタの縦断面図である。FIG. 7 is a longitudinal sectional view of the adapter shown in FIG. 図８は、図６のＢ−Ｂ線断面図である。8 is a cross-sectional view taken along the line BB in FIG. 図９は、本発明の薬剤調製用具に使用される外筒の拡大平面図である。FIG. 9 is an enlarged plan view of an outer cylinder used in the drug preparation device of the present invention. 図１０は、本発明の薬剤調製用具に使用される外筒封止部材の拡大正面図である。FIG. 10 is an enlarged front view of an outer cylinder sealing member used in the drug preparation device of the present invention. 図１１は、図１０に示した外筒封止部材の縦断面図である。FIG. 11 is a longitudinal sectional view of the outer cylinder sealing member shown in FIG. 図１２は、本発明の薬剤調製用具に使用される薬剤容器封止部材の拡大正面図である。FIG. 12 is an enlarged front view of a drug container sealing member used in the drug preparation tool of the present invention. 図１３は、図１２に示した薬剤容器封止部材の縦断面図である。13 is a longitudinal sectional view of the drug container sealing member shown in FIG. 図１４は、本発明の薬剤調製用具に使用される他の例のプレフィルドシリンジの外観図である。FIG. 14 is an external view of another example of a prefilled syringe used in the drug preparation device of the present invention. 図１５は、本発明の薬剤調製用具の作用を説明するための説明図である。FIG. 15 is an explanatory diagram for explaining the operation of the drug preparation device of the present invention. 図１６は、本発明の薬剤調製用具の作用を説明するための説明図である。FIG. 16 is an explanatory diagram for explaining the operation of the drug preparation device of the present invention. 図１７は、本発明の薬剤調製用具の作用を説明するための説明図である。FIG. 17 is an explanatory diagram for explaining the operation of the drug preparation device of the present invention. 図１８は、本発明の薬剤調製用具の作用を説明するための説明図である。FIG. 18 is an explanatory diagram for explaining the operation of the drug preparation device of the present invention.

以下、本発明の薬剤調製用具を図面に示す実施例に基づいて説明する。
本発明の薬剤調製用具は、他の医療用具（図示せず）のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なノズル部２２を先端部に備えるシリンジ用外筒２０と、シリンジ用外筒２０と、外筒２０の先端部に着脱可能に装着され、かつ、ノズル部２２への他の医療用具（図示せず）との接続を阻害するアダプタ４と、筒先部３５を有する薬剤容器３０とを有する。
そして、図面に示す実施例の薬剤調製用具１は、プレフィルドシリンジ２および薬剤収納済薬剤容器３を用いるものとなっている。 Hereinafter, the pharmaceutical preparation tool of the present invention will be described based on examples shown in the drawings.
The drug preparation device of the present invention includes a syringe outer cylinder 20 having a nozzle portion 22 that can be connected to a female connection portion having a female luer taper conforming to the ISO standard of other medical devices (not shown) at the tip portion. , The syringe outer cylinder 20, the adapter 4 that is detachably attached to the distal end portion of the outer cylinder 20, and obstructs the connection of the medical device (not shown) to the nozzle portion 22, and the barrel tip portion 35. And a medicine container 30 having
And the chemical | medical agent preparation tool 1 of the Example shown to drawing uses the prefilled syringe 2 and the chemical | medical agent accommodation chemical | medical agent container 3. FIG.

この薬剤調製用具１は、他の医療用具（図示せず）のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なノズル部２２を先端部に備えるシリンジ用外筒２０と、外筒２０内に収納された摺動可能なガスケット８と、ガスケット８の基端に取り付けられたもしくは取付可能なプランジャ５と、外筒２０の先端部に着脱可能に装着されたアダプタ４と、外筒２０内に充填された医療用液体１１とを備えるプレフィルドシリンジ２と、筒先部３５を有する薬剤容器３０と、薬剤容器３０内に収納された薬剤とを有する薬剤収納済薬剤容器３とからなる。 The drug preparation tool 1 includes a syringe outer cylinder 20 having a nozzle part 22 that can be connected to a female connection part having a female luer taper that conforms to the ISO standard of other medical tools (not shown), A slidable gasket 8 housed in the outer cylinder 20, a plunger 5 attached to or attachable to the proximal end of the gasket 8, and an adapter 4 detachably attached to the distal end of the outer cylinder 20; From the prefilled syringe 2 including the medical liquid 11 filled in the outer cylinder 20, the drug container 30 having the cylinder tip 35, and the drug-stored drug container 3 having the drug stored in the drug container 30 Become.

そして、アダプタ４は、一端より他端まで貫通した筒状体であり、一端側に、外筒２０の先端部に液密に接続可能な外筒接続部４１を備え、他端側に、薬剤容器３０の筒先部３５に液密に接続可能であり、かつ、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部との接続が不能な薬剤容器接続部４２とを備える。
アダプタ４は、外筒２０に装着された状態において、外筒２０のノズル部２２へのＩＳＯ規格に適合したメス型接続部との接続を阻害し、アダプタ４が装着された外筒２０は、薬剤容器３０の筒先部３５に、アダプタ４の薬剤容器接続部４２を用いて接続可能であり、かつ、接続後、アダプタ４とともに薬剤容器３０を外筒２０より離脱可能であり、アダプタ４の離脱により、外筒２０のＩＳＯ規格に適合したオスルアーテーパーを有しノズル部２２が露出し、他の医療用具のＩＳＯ規格に適合したメス型接続部との接続が可能となる。 The adapter 4 is a cylindrical body that penetrates from one end to the other end. The adapter 4 includes an outer cylinder connecting portion 41 that can be liquid-tightly connected to the distal end portion of the outer cylinder 20 on one end side, and a drug on the other end side. A drug container connection portion 42 that can be connected in a liquid-tight manner to the tube tip portion 35 of the container 30 and cannot be connected to a female connection portion having a female luer taper that conforms to the ISO standard of other medical devices. .
When the adapter 4 is attached to the outer cylinder 20, the adapter 4 obstructs the connection with the female connector conforming to the ISO standard to the nozzle portion 22 of the outer cylinder 20, and the outer cylinder 20 to which the adapter 4 is attached is It can be connected to the tube tip 35 of the drug container 30 using the drug container connection part 42 of the adapter 4, and after connection, the drug container 30 can be detached from the outer cylinder 20 together with the adapter 4. Accordingly, the nozzle portion 22 having a male luer taper that conforms to the ISO standard of the outer cylinder 20 is exposed, and connection with a female connector conforming to the ISO standard of other medical devices becomes possible.

この実施例の薬剤調製用具１は、図１および図２に示すように、アダプタ４が着脱可能に装着されたプレフィルドシリンジ２と、薬剤容器３とを備える。
プレフィルドシリンジ２は、シリンジ用外筒２０と、外筒２０内に収納され、かつ液密状態にて摺動可能なガスケット８と、外筒２０内に充填された医療用液体１１と、ガスケット８の基端に取り付けられたプランジャ５と、外筒２０のノズル部２２を備える先端部に装着されたアダプタ４と、アダプタ４が装着された外筒２０の先端部を封止する外筒封止部材７とを備える。なお、図１４に示す実施例のプレフィルドシリンジ２ａのように、プランジャ５は、ガスケットに取り付けられておらず、使用時に、ガスケット８に装着するものであってもよい。
外筒２０は、図１ないし図３に示すように、本体部２１と、ノズル部２２を有する先端部と、フランジ２４とを備える。本体部２１は、ほぼ円筒状となっており、内部に液体収納空間を有している。 As shown in FIGS. 1 and 2, the drug preparation tool 1 of this embodiment includes a prefilled syringe 2 to which an adapter 4 is detachably attached, and a drug container 3.
The prefilled syringe 2 includes a syringe outer cylinder 20, a gasket 8 accommodated in the outer cylinder 20 and slidable in a liquid-tight state, a medical liquid 11 filled in the outer cylinder 20, and a gasket 8. An outer cylinder sealing that seals the distal end portion of the outer cylinder 20 to which the adapter 4 is attached, and the plunger 5 attached to the distal end portion of the outer cylinder 20 provided with the nozzle portion 22. Member 7. In addition, like the prefilled syringe 2a of the Example shown in FIG. 14, the plunger 5 may not be attached to a gasket, but may be attached to the gasket 8 at the time of use.
As shown in FIGS. 1 to 3, the outer cylinder 20 includes a main body portion 21, a tip portion having a nozzle portion 22, and a flange 24. The main body 21 is substantially cylindrical and has a liquid storage space inside.

プレフィルドシリンジ２の外筒２０のノズル部２２は、本体部２１の肩部より先端方向に突出している。さらに、外筒２０の先端部は、図１ないし図３に示すように、ノズル部２２を被包する外筒カラー部２３を備えている。そして、外筒カラー部２３の内面には外筒側螺合部２５が形成されている。また、ノズル部２２の先端は、外筒カラー部２３より、若干突出している。ノズル部２２は、他の医療用具（図示せず）のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能なものとなっている。このため、注射針のハブ、三方活栓のポート、輸液セットのコネクターのポートなどとの接続が可能である。特に、ノズル部２２は、ＩＳＯ規格に適合したオスルアーテーパーを有するものであることが好ましい。なお、上記のメス型接続部に液密状態にて接続可能であれば、ＩＳＯ規格に適合したオスルアーテーパーを有しないものであってもよい。 The nozzle portion 22 of the outer cylinder 20 of the prefilled syringe 2 protrudes from the shoulder portion of the main body portion 21 in the distal direction. Further, as shown in FIGS. 1 to 3, the distal end portion of the outer cylinder 20 includes an outer cylinder collar portion 23 that encloses the nozzle portion 22. An outer cylinder side screwing portion 25 is formed on the inner surface of the outer cylinder collar portion 23. Further, the tip of the nozzle portion 22 slightly protrudes from the outer cylinder collar portion 23. The nozzle part 22 can be connected to a female connection part having a female luer taper conforming to the ISO standard of other medical devices (not shown). For this reason, connection with the hub of a syringe needle, the port of a three-way cock, the port of the connector of an infusion set, etc. is possible. In particular, the nozzle portion 22 preferably has a male luer taper that conforms to the ISO standard. In addition, as long as it can connect to said female type connection part in a liquid-tight state, it may not have a male luer taper that conforms to the ISO standard.

そして、この実施例では、外筒２０は、外筒側螺合部２５を備え、後述するアダプタ４の外筒接続部４１は、外筒側螺合部２５と螺合可能なアダプタ側螺合部４３を備えている。具体的には、外筒２０は、ノズル部２２を被包する外筒カラー部２３を備え、外筒カラー部２３は外筒側螺合部２５を備えるものとなっている。
フランジ２４は、外筒２０の基端全周より垂直方向に突出するように形成された楕円ドーナツ状の円盤部である。フランジ２４は、図１ないし図３に示すように向かい合う２つの把持部を備え、さらに、把持部の先端面側には、複数のリブが形成されている。外筒２０は、透明もしくは半透明材料により、必要に応じて、酸素透過性、水蒸気透過性の少ない材料により形成された筒状体である。 In this embodiment, the outer cylinder 20 includes an outer cylinder side screwing portion 25, and an outer cylinder connection portion 41 of the adapter 4 to be described later is screwed to the outer cylinder side screwing portion 25. A portion 43 is provided. Specifically, the outer cylinder 20 includes an outer cylinder collar portion 23 that encloses the nozzle portion 22, and the outer cylinder collar portion 23 includes an outer cylinder side screwing portion 25.
The flange 24 is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire circumference of the base end of the outer cylinder 20. The flange 24 includes two gripping portions facing each other as shown in FIGS. 1 to 3, and a plurality of ribs are formed on the distal end side of the gripping portion. The outer cylinder 20 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having little oxygen permeability and water vapor permeability.

外筒２０の形成材料としては、例えば、ポリプロピレン、ポリエチレン、ポリスチレン、ポリアミド、ポリカーボネート、ポリ塩化ビニル、ポリ−（４−メチルペンテン−１）、アクリル樹脂、アクリロニトリル−ブタジエン−スチレン共重合体、ポリエチレンテレフタレート等のポリエステル、環状ポリオレフィンのような各種樹脂が挙げられるが、その中でも成形が容易で耐熱性があることから、
ポリプロピレン、環状ポリオレフィンのような樹脂が好ましい。 Examples of the material for forming the outer cylinder 20 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyester and cyclic polyolefin, etc., among them, are easy to mold and heat resistant,
Resins such as polypropylene and cyclic polyolefin are preferred.

ガスケット８は、図１ないし図３に示すようにほぼ同一外径にて延びる本体部と、この本体部に設けられた複数の環状リブを備え、これらリブが、外筒２０の本体部２１の内面に液密に接触しながら移動する。ガスケット８の形成材料としては、弾性を有するゴム（例えば、ブチルゴム、ラテックスゴム、シリコーンゴム、スチレン−ブタジエンゴム、イソプレンゴムなど）、熱可塑性エラストマー（例えば、ＳＢＳエラストマー、ＳＥＢＳエラストマー、ＳＥＰＳエラストマー等のスチレン系エラストマー、エチレン−αオレフィン共重合体エラストマー等のオレフィン系エラストマーなど）等を使用することが好ましい。 As shown in FIGS. 1 to 3, the gasket 8 includes a main body portion extending with substantially the same outer diameter, and a plurality of annular ribs provided on the main body portion, and these ribs are formed on the main body portion 21 of the outer cylinder 20. Moves in liquid-tight contact with the inner surface. As a material for forming the gasket 8, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene-butadiene rubber, isoprene rubber, etc.), thermoplastic elastomer (for example, SBS elastomer, SEBS elastomer, SEPS elastomer, styrene, etc.) It is preferable to use olefin-based elastomers, olefin-based elastomers such as ethylene-α-olefin copolymer elastomers, and the like.

そして、ガスケット８には、その基端部より内部に延びる凹部が設けられ、この凹部が、プランジャ装着部となっている。具体的には、プランジャ装着部は、雌ねじ状となっており、プランジャ５の先端部に形成されたガスケット装着部５２の外面に形成された雄ねじ部と螺合可能となっている。両者が螺合することにより、プランジャ５は、ガスケット８に装着される。
プランジャ５は、図１ないし図３に示すように、断面十字状の軸方向に延びる本体部５１と、先端部に設けられたガスケット装着部５２と、本体部の基端部に設けられた押圧部５３とを備えている。この実施例のプランジャ５では、プランジャ装着部５２の外面には、プランジャ装着部と螺合する雄ねじ部が形成されている。そして、プランジャ装着部とガスケット装着部が螺合することにより、プランジャ５は、ガスケット８に接続される。
プレフィルドシリンジ２内に充填される医療用液体１１としては、注射用蒸留水、生理食塩水、ブドウ糖水溶液などの薬剤溶解液、さらには、薬剤（例えば、ビタミン剤、ミネラル類）を含有するとともに、薬剤容器内の薬剤の溶解が可能な薬液でもあってもよい。 The gasket 8 is provided with a recess extending inward from the base end portion, and this recess serves as a plunger mounting portion. Specifically, the plunger mounting portion has a female screw shape, and can be screwed with a male screw portion formed on the outer surface of the gasket mounting portion 52 formed at the distal end portion of the plunger 5. The plunger 5 is mounted on the gasket 8 by screwing them together.
As shown in FIGS. 1 to 3, the plunger 5 includes a main body 51 extending in the cross-sectional axial direction, a gasket mounting portion 52 provided at the distal end, and a pressing provided at the base end of the main body. Part 53. In the plunger 5 of this embodiment, a male thread portion that is screwed with the plunger mounting portion is formed on the outer surface of the plunger mounting portion 52. The plunger 5 is connected to the gasket 8 when the plunger mounting portion and the gasket mounting portion are screwed together.
The medical liquid 11 filled in the prefilled syringe 2 contains a drug solution such as distilled water for injection, physiological saline, and aqueous glucose solution, and further contains a drug (for example, vitamins and minerals), It may be a chemical solution capable of dissolving the drug in the drug container.

そして、アダプタ４は、図１ないし図８に示すように、一端より他端まで貫通した筒状体であり、一端側に、外筒２０の先端部に装着される外筒接続部４１を備え、他端側に、薬剤容器３０の筒先部３５に接続可能な薬剤容器接続部４２を備える。そして、アダプタ４が装着された外筒２０は、図２に示すように、ノズル部２２が露出せず、ノズル部２２への医療用具の接続を不能なものとしている。また、外筒２２に装着されたアダプタ４の薬剤容器接続部４２は、ＩＳＯ規格に適合したオスルアーテーパーを持たず、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部との接続が不能なものとなっている。 As shown in FIGS. 1 to 8, the adapter 4 is a cylindrical body that penetrates from one end to the other end, and is provided with an outer cylinder connecting portion 41 that is attached to the tip of the outer cylinder 20 on one end side. The other end side is provided with a drug container connecting portion 42 that can be connected to the tube tip portion 35 of the drug container 30. As shown in FIG. 2, the outer cylinder 20 to which the adapter 4 is attached does not expose the nozzle portion 22 and makes it impossible to connect the medical device to the nozzle portion 22. In addition, the drug container connecting portion 42 of the adapter 4 attached to the outer cylinder 22 does not have a male luer taper conforming to the ISO standard, but has a female luer taper conforming to the ISO standard for other medical devices. Connection with is impossible.

アダプタ４は、一端側に、外筒２０のＩＳＯ規格に適合したオスルアーテーパーを有するノズル部２２の先端部を収納可能な筒状の外筒接続部４１を備える。また、外筒接続部４１は、外筒２０のノズル部２２とカラー部２３間に進入可能なものとなっている。さらに、外筒接続部４１の外面には、外筒２０の外筒側螺合部２５と螺合可能なアダプタ側螺合部４３が設けられている。さらに、アダプタ４は、内面に設けられ、外筒２０のノズル部２２の外面と液密状態にて接触する環状リブ４５を備えている。このため、図５に示すように、アダプタ４は、外筒２２の先端部（ノズル部）に液密状態に装着されている。なお、外筒接続部４１は、ＩＳＯ規格に適合したメスルアーテーパーを有するものとし、両者が、液密状態を形成可能なテーパー嵌合を形成するものであってもよい。 The adapter 4 includes, on one end side, a cylindrical outer cylinder connecting portion 41 that can accommodate the tip of the nozzle portion 22 having a male luer taper that conforms to the ISO standard of the outer cylinder 20. Further, the outer cylinder connection portion 41 can enter between the nozzle portion 22 and the collar portion 23 of the outer cylinder 20. Furthermore, an adapter side screwing portion 43 that can be screwed with the outer tube side screwing portion 25 of the outer tube 20 is provided on the outer surface of the outer tube connecting portion 41. Furthermore, the adapter 4 includes an annular rib 45 that is provided on the inner surface and contacts the outer surface of the nozzle portion 22 of the outer cylinder 20 in a liquid-tight state. For this reason, as shown in FIG. 5, the adapter 4 is mounted in a liquid-tight state on the distal end portion (nozzle portion) of the outer cylinder 22. In addition, the outer cylinder connection part 41 shall have a female luer taper suitable for the ISO standard, and both may form the taper fitting which can form a liquid-tight state.

アダプタ４は、他端側に、薬剤容器３０の筒先部３５の先端部を収納可能な筒状の薬剤容器接続部４２を備える。薬剤容器接続部４２は、後述する薬剤容器３０の筒先部３５とカラー部３３間に進入可能なものとなっている。さらに、アダプタ４は、ノズル部２２と接触する環状リブ４５より他端側となる位置に設けられ、薬剤容器３０の筒先部３５の外面と液密状態にて接触する環状リブ４４を備えている。このため、図１６に示すように、アダプタ４は、薬剤容器３０を液密状態にて接続することが可能となっている。
また、この実施例の薬剤容器３０では、薬剤容器３０の筒先部３５の先端部は、アダプタ４の薬剤容器接続部内に進入可能なものとなっている。このため、薬剤容器３０のアダプタ４への装着時において、アダプタ４内のデッドボリュームが少なく、アダプタ４内の薬剤の残留が少ない移送を可能としている。 The adapter 4 includes, on the other end side, a cylindrical drug container connection portion 42 that can store the tip of the tube tip portion 35 of the drug container 30. The medicine container connection part 42 can be inserted between a tube tip part 35 and a collar part 33 of the medicine container 30 described later. Furthermore, the adapter 4 includes an annular rib 44 that is provided at a position on the other end side from the annular rib 45 that contacts the nozzle portion 22 and that contacts the outer surface of the tube tip portion 35 of the drug container 30 in a liquid-tight state. . For this reason, as shown in FIG. 16, the adapter 4 can connect the medicine container 30 in a liquid-tight state.
Further, in the medicine container 30 of this embodiment, the distal end portion of the tube tip portion 35 of the medicine container 30 can enter the medicine container connecting portion of the adapter 4. For this reason, when the medicine container 30 is attached to the adapter 4, the dead volume in the adapter 4 is small and the medicine in the adapter 4 is little left.

そして、この実施例のアダプタ４と外筒２０は、アダプタ４の外筒２０からの離脱を規制する離脱規制機構を備えている。具体的には、図５ないし図７に示すように、この実施例のアダプタ４では、薬剤容器接続部４２は、外筒接続部４１より拡径した筒状部となっている。そして、薬剤容器接続部４２は、一端側を向く環状端面（言い換えれば、拡径部の環状下面）を有している。そして、この環状端面には、外筒接続部４１方向（言い換えれば、下方）に突出するリブ４８が設けられている。そして、外筒２０のカラー部２３の先端面には、上記リブ４８の先端部を受け入れる凹部２６が設けられている。そして、リブ４８および凹部２６は、複数（好ましくは、２〜６個、この実施例では、４個）、カラー部２３およびアダプタ４の中心軸に対して、等角度に配置されている。図５および図１６に示すように、アダプタ４が外筒２０に装着された状態では、このリブ４８と凹部２６が係合している。そして、両者の係合により、アダプタ４の外筒２０に対する回転が規制され、アダプタ４の外筒２０からの不用意な離脱を防止している。 The adapter 4 and the outer cylinder 20 of this embodiment are provided with a detachment restricting mechanism that restricts the detachment of the adapter 4 from the outer cylinder 20. Specifically, as shown in FIGS. 5 to 7, in the adapter 4 of this embodiment, the medicine container connecting portion 42 is a cylindrical portion whose diameter is larger than that of the outer tube connecting portion 41. And the chemical | medical agent container connection part 42 has the cyclic | annular end surface (in other words, the cyclic | annular lower surface of an enlarged diameter part) which faces one end side. The annular end face is provided with a rib 48 that protrudes in the direction of the outer cylinder connecting portion 41 (in other words, downward). A recess 26 for receiving the tip of the rib 48 is provided on the tip of the collar portion 23 of the outer cylinder 20. A plurality of ribs 48 and recesses 26 (preferably 2 to 6, in this embodiment, 4) are arranged at an equal angle with respect to the central axis of the collar portion 23 and the adapter 4. As shown in FIGS. 5 and 16, in a state where the adapter 4 is mounted on the outer cylinder 20, the rib 48 and the recess 26 are engaged. Then, due to the engagement between them, the rotation of the adapter 4 with respect to the outer cylinder 20 is restricted, and the adapter 4 is prevented from being inadvertently detached from the outer cylinder 20.

そして、アダプタ４が接続された外筒２０には、図５に示すように、外筒封止部材７が装着され、外筒２０は、液密状態にシールされている。封止部材７は、図１０および図１１に示すように、円盤状の本体部７１と、本体部７１の中心部より突出し、アダプタの薬剤容器接続部４２内に進入し、かつ、外筒２０のノズル部２２の先端面と当接可能な突出部７２と突出部７２を取り囲むように形成された封止部材カラー部７３を備えている。そして、封止部材カラー部７３の内面には、外筒２０のカラー部２３の外面に密接可能に形成された環状リブ７４が設けられている。また、突出部７２は、外面が円柱状に形成されており、アダプタ４の環状リブ４４と液密状態に接触するものとなっている。また、この実施例のものでは、突出部７２の先端面もノズル部２２の先端面と液密に当接可能なものとなっている。さらに、封止部材カラー部７３は、図５に示すように、外筒２０より突出する（露出する）アダプタ４の薬剤容器接続部４２の外側面を被包するものの外側面と接触しないものとなっている。このため、封止部材７を回転させてもその回転力が、アダプタ４に伝達されにくく、アダプタ４の離脱を防止している。なお、封止部材７は、回転させることなく、軸方向に引く（図５における上方に引く）ことにより、外筒２０より、離脱する。 As shown in FIG. 5, the outer cylinder sealing member 7 is attached to the outer cylinder 20 to which the adapter 4 is connected, and the outer cylinder 20 is sealed in a liquid-tight state. As shown in FIGS. 10 and 11, the sealing member 7 protrudes from the disc-shaped main body 71 and the central portion of the main body 71, enters the medicine container connecting portion 42 of the adapter, and the outer cylinder 20. And a sealing member collar portion 73 formed so as to surround the protruding portion 72. An annular rib 74 is formed on the inner surface of the sealing member collar portion 73 so as to be in close contact with the outer surface of the collar portion 23 of the outer cylinder 20. Further, the protruding portion 72 has an outer surface formed in a columnar shape, and comes into contact with the annular rib 44 of the adapter 4 in a liquid-tight state. In this embodiment, the front end surface of the projecting portion 72 can also come into liquid-tight contact with the front end surface of the nozzle portion 22. Further, as shown in FIG. 5, the sealing member collar portion 73 does not come into contact with the outer surface of the encapsulating outer surface of the drug container connecting portion 42 of the adapter 4 protruding (exposed) from the outer cylinder 20. It has become. For this reason, even if the sealing member 7 is rotated, the rotational force is not easily transmitted to the adapter 4, thereby preventing the adapter 4 from being detached. The sealing member 7 is detached from the outer cylinder 20 by being pulled in the axial direction without being rotated (pulled upward in FIG. 5).

外筒封止部材７および後述する薬剤容器封止部材の形成材料としては、例えば、ポリプロピレン、ポリエチレン、ポリスチレン、ポリアミド、ポリカーボネート、ポリ塩化ビニル、ポリ−（４−メチルペンテン−１）、アクリル樹脂、アクリロニトリル−ブタジエン−スチレン共重合体、ポリエチレンテレフタレート等のポリエステル、環状ポリオレフィンのような各種樹脂が挙げられるが、その中でも成形が容易で耐熱性があることから、ポリプロピレン、環状ポリオレフィンのような樹脂が好ましい。 As a forming material of the outer cylinder sealing member 7 and a drug container sealing member described later, for example, polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, Various resins such as acrylonitrile-butadiene-styrene copolymers, polyesters such as polyethylene terephthalate, and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and heat resistant. .

図１ないし図４および図１６に示すように、本発明の薬剤投与具に用いられる薬剤収納済薬剤容器３は、筒先部３５を有する薬剤容器３０と、薬剤容器３０内に収納された薬剤１０と、薬剤容器３０内を液密状態にて摺動可能な薬剤容器用ガスケット３２と、薬剤容器３０の筒先部３５を封止する薬剤容器封止部材６を備えている。
薬剤容器３０は、先端から基端まで貫通した筒状本体部３１と、先端が開口した筒先部３５と、基端に設けられたフランジ３４と、筒先部３５を被包する薬剤容器カラー部３３とを備える。 As shown in FIG. 1 to FIG. 4 and FIG. 16, the medicine-contained medicine container 3 used in the medicine administration device of the present invention includes a medicine container 30 having a tube tip 35 and a medicine 10 housed in the medicine container 30. And a medicine container gasket 32 that can slide in the medicine container 30 in a liquid-tight state, and a medicine container sealing member 6 that seals the tube tip 35 of the medicine container 30.
The drug container 30 includes a cylindrical main body portion 31 penetrating from the distal end to the proximal end, a tubular distal end portion 35 having an opened distal end, a flange 34 provided at the proximal end, and a pharmaceutical container collar portion 33 that encloses the tubular distal end portion 35. With.

筒先部３５は、薬剤容器３０の本体部３１の先端より、先端方向に延びかつ、本体部より小径の筒状部となっている。また、筒先部３５は、ＩＳＯ規格のオスルアーテーパーでなく、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部との接続が不能なものとなっている。カラー部３３は、筒先部３５と離間し、かつ、その外周を被包する筒状部である。そして、この実施例では、カラー部３３の先端は、筒先部３５の先端より、先端側に突出している。このため、筒先部３５は、露出しないものとなっている。また、この薬剤容器３０において用いられるガスケット３２は、プランジャ等の押圧手段が接続不能なものとなっている。
薬剤容器３０としては、開口部を有し、内部に薬剤１０を収納可能なものであれば、どのようなものであってもよい。例えば、硬質もしくは半硬質合成樹脂製容器、ガラス容器など、さらには、上述した外筒の形成材料が使用される。 The cylinder tip part 35 is a cylindrical part that extends in the distal direction from the distal end of the body part 31 of the drug container 30 and has a smaller diameter than the body part. Further, the tube tip portion 35 is not an ISO standard male luer taper, and cannot be connected to a female connection portion having a female luer taper conforming to the ISO standard of other medical devices. The collar portion 33 is a tubular portion that is separated from the tube tip portion 35 and encloses the outer periphery thereof. In this embodiment, the distal end of the collar portion 33 protrudes further toward the distal end side than the distal end of the tube tip portion 35. For this reason, the tube tip 35 is not exposed. Further, the gasket 32 used in the medicine container 30 cannot be connected to a pressing means such as a plunger.
The drug container 30 may be anything as long as it has an opening and can store the drug 10 inside. For example, the outer cylinder forming material described above, such as a rigid or semi-rigid synthetic resin container or a glass container, is used.

薬剤としては、外筒２０内に充填される医療用液体１１に溶解するものであれば、粉末状薬剤、凍結乾燥薬剤、固形状薬剤、液状薬剤などどのようなものであってもよい。薬剤としては、例えば、ビタミン剤（総合ビタミン剤）、各種アミノ酸、ヘパリンのような抗血栓剤、インシュリン、抗生物質、抗腫瘍剤、鎮痛剤、強心剤、静注麻酔剤、抗パーキンソン剤、潰瘍治療剤、副腎皮質ホルモン剤、不整脈用剤、ホルモン製剤、インターフェロン製剤、ヒト免疫グロブリン製剤、血液凝固因子製剤、ワクチン製剤などのタンパク製剤等が挙げられる。 As the medicine, any medicine such as powder medicine, freeze-dried medicine, solid medicine, liquid medicine and the like may be used as long as it dissolves in the medical liquid 11 filled in the outer cylinder 20. Examples of drugs include vitamins (general vitamins), various amino acids, antithrombotics such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, and ulcer treatments Agents, corticosteroids, arrhythmic agents, hormone preparations, interferon preparations, human immunoglobulin preparations, blood coagulation factor preparations, vaccine preparations, and other protein preparations.

そして、薬剤容器３０の筒先部３５には、図１および図３に示すように、薬剤容器封止部材６が装着され、薬剤容器３０は、液密状態にシールされている。封止部材６は、図３、図４、図１２および図１３に示すように、円盤状の本体部６１と、本体部６１より突出し、薬剤容器３０のカラー部３３と筒先部３５内に進入可能な筒状部６２とを備えている。筒状部６２は、筒先部３５の先端部を収納可能なものとなっている。さらに、筒状部６２の内面には、筒先部３５の外周面と液密状態にて接触する環状リブ６３を備えている。さらに、筒状部６２の外面には、薬剤容器３０のカラー部３３の内面に設けられた突出部３６を受け入れるための溝部６４を備えている。さらに、この実施例の封止部材６では、図１２および図１３に示すように、溝部６４は、溝部６４の下端に設けられ、溝部よりさらに窪み、後述するリブ３７を収納可能な凹部６５を備えている。また、この封止部材６では、溝部６４の他端（図１２および図１３の上端）に、溝部６４に薬剤容器３０の突出部３６の誘導を行うための拡幅部６６を備えている。拡幅部６６は、最も幅の広い始端より溝部に向かって徐々に幅が狭くなる略台形状のものとなっている。 As shown in FIG. 1 and FIG. 3, the drug container sealing member 6 is attached to the tube tip portion 35 of the drug container 30, and the drug container 30 is sealed in a liquid-tight state. As shown in FIGS. 3, 4, 12, and 13, the sealing member 6 protrudes from the disc-shaped main body portion 61 and the main body portion 61 and enters the collar portion 33 and the tube tip portion 35 of the drug container 30. And a possible cylindrical portion 62. The cylindrical portion 62 can store the tip end portion of the cylindrical tip portion 35. Furthermore, the inner surface of the cylindrical part 62 is provided with an annular rib 63 that is in liquid-tight contact with the outer peripheral surface of the cylindrical tip part 35. Furthermore, the outer surface of the cylindrical part 62 is provided with a groove part 64 for receiving the protruding part 36 provided on the inner surface of the collar part 33 of the medicine container 30. Furthermore, in the sealing member 6 of this embodiment, as shown in FIGS. 12 and 13, the groove portion 64 is provided at the lower end of the groove portion 64, further recessed from the groove portion, and provided with a recess 65 that can accommodate a rib 37 described later. I have. Further, in the sealing member 6, a widening portion 66 for guiding the protruding portion 36 of the drug container 30 is provided in the groove portion 64 at the other end of the groove portion 64 (upper end in FIGS. 12 and 13). The widened portion 66 has a substantially trapezoidal shape whose width gradually decreases from the widest starting end toward the groove.

そして、この実施例の薬剤調製用具１では、薬剤容器３０とアダプタ４は、薬剤容器３０にて付与した回転力をアダプタ４に伝達可能な回転力伝達機構を備えている。さらに、この実施例の薬剤調製用具１では、薬剤容器３０とアダプタ４は、薬剤容器３０のアダプタ４への接続後において、アダプタ４からの薬剤容器３０の分離を規制する分離規制機構を備えている。
具体的には、図３、図４、図６ないし図８に示すように、薬剤容器３０は、カラー部３３の内面に設けられた軸方向に延びる突出部３６を有する。この例では、突出部３６は、複数（具体的には、カラー部の中心軸に対して等角度に３つ）設けられている。また、突出部３６は、図１６に示すように、その端部（具体的には、突出部３６の端部でありかつカラー部３３の開口端部）に設けられた内側に突出するリブ３７を備えている。 In the drug preparation tool 1 of this embodiment, the drug container 30 and the adapter 4 are provided with a rotational force transmission mechanism that can transmit the rotational force applied by the drug container 30 to the adapter 4. Furthermore, in the drug preparation tool 1 of this embodiment, the drug container 30 and the adapter 4 are provided with a separation regulating mechanism that regulates the separation of the drug container 30 from the adapter 4 after the drug container 30 is connected to the adapter 4. Yes.
Specifically, as shown in FIGS. 3, 4, 6 to 8, the drug container 30 has a protruding portion 36 that is provided on the inner surface of the collar portion 33 and extends in the axial direction. In this example, a plurality of protrusions 36 (specifically, three at an equal angle with respect to the central axis of the collar portion) are provided. Further, as shown in FIG. 16, the protruding portion 36 is an inwardly protruding rib 37 provided at an end portion thereof (specifically, an end portion of the protruding portion 36 and an opening end portion of the collar portion 33). It has.

そして、アダプタ４は、薬剤容器接続部４２の外側面に設けられ、上記薬剤容器３０の突出部３６およびリブ３７を収納可能な溝部４６を有する。溝部４６も突出部３６の形成形態に対応して、複数（具体的には、アダプタの中心軸に対して等角度に３つ）設けられている。そして、溝部４６は、一端（図６および図７の下端）に、さらに窪み、上述したリブ３７を収納可能な凹部４７を備えている。また、このアダプタ４では、溝部４６の他端（図６および図７の上端）に、溝部４に薬剤容器３０の突出部３６の誘導を行うための拡幅部４９を備えている。拡幅部４９は、最も幅の広い始端より溝部に向かって徐々に幅が狭くなる略台形状のものとなっている。 The adapter 4 is provided on the outer surface of the drug container connecting portion 42 and has a groove 46 that can accommodate the protruding portion 36 and the rib 37 of the drug container 30. A plurality of groove portions 46 (specifically, three at equal angles with respect to the center axis of the adapter) are also provided corresponding to the form of formation of the protruding portion 36. And the groove part 46 is further provided with the recessed part 47 which can be further depressed and can accommodate the rib 37 mentioned above in one end (lower end of FIG. 6 and FIG. 7). In addition, the adapter 4 includes a widened portion 49 for guiding the protruding portion 36 of the drug container 30 in the groove portion 4 at the other end of the groove portion 46 (upper end in FIGS. 6 and 7). The widened portion 49 has a substantially trapezoidal shape whose width gradually decreases from the widest starting end toward the groove.

そして、この実施例の薬剤調製用具１では、図１６に示すように、薬剤容器３０がアダプタ４に接続されたとき、薬剤容器３０の突出部３６が、アダプタ４の溝部４６に収納され、薬剤容器３０の突出部３６のリブ３７が、アダプタ４の溝部４６の凹部４７に収納され、係合した状態となる。このため、薬剤容器３０は、軽くアダプタ４と反対方向に引っ張っても、アダプタ４より離脱しない。よって、薬剤容器３０の突出部３６のリブ３７と、アダプタ４の溝部４６の凹部４７により、接続後における薬剤容器３０からのアダプタ４の離脱を規制する分離規制機構が形成されている。 In the drug preparation tool 1 of this embodiment, as shown in FIG. 16, when the drug container 30 is connected to the adapter 4, the protruding portion 36 of the drug container 30 is accommodated in the groove 46 of the adapter 4. The rib 37 of the protrusion part 36 of the container 30 is accommodated in the recessed part 47 of the groove part 46 of the adapter 4, and will be in the engaged state. For this reason, the medicine container 30 is not detached from the adapter 4 even if it is pulled lightly in the opposite direction to the adapter 4. Therefore, the rib 37 of the protrusion part 36 of the medicine container 30 and the concave part 47 of the groove part 46 of the adapter 4 form a separation restriction mechanism that restricts the detachment of the adapter 4 from the medicine container 30 after connection.

そして、薬剤容器３０を回転させたとき、薬剤容器３０の突出部３６が、アダプタ４の溝部４６の内面に当接し、回転力がアダプタに伝達される。よって、薬剤容器３０の突出部３６と、アダプタ４の溝部４６により、回転力伝達機構が形成されている。そして、この実施例の薬剤調製用具１では、上記の回転力伝達機構と分離規制機構を備えることにより、薬剤容器３０のアダプタ４への接続後において、薬剤容器を回転させることにより、アダプタを薬剤容器とともに外筒より容易に離脱可能なものとなっている。図８に示すように、溝部４６および突出部３６は、横断面形状が概ね矩形状のものとなっているが、半円状などの他の形状であってもよい。
また、この実施例では、回転力伝達機構として、薬剤容器３０側に凸部を設け、アダプタ４側に凸部と係合する凹部を有するものとなっているが、これに限らず、薬剤容器側に凹部を設け、アダプタ側に凹部と係合する凸部を設けてもよい。さらには、薬剤容器とアダプタの双方に、互いに係合する凸部と凹部をそれぞれ設けてもよい。 When the medicine container 30 is rotated, the protruding portion 36 of the medicine container 30 comes into contact with the inner surface of the groove 46 of the adapter 4, and the rotational force is transmitted to the adapter. Therefore, the protrusion 36 of the medicine container 30 and the groove 46 of the adapter 4 form a rotational force transmission mechanism. And in the chemical | medical agent preparation tool 1 of this Example, by providing said rotational force transmission mechanism and isolation | separation control mechanism, after connecting the chemical | medical agent container 30 to the adapter 4, an adapter is made into a chemical | medical agent by rotating. It can be easily detached from the outer cylinder together with the container. As shown in FIG. 8, the cross-sectional shape of the groove part 46 and the protrusion part 36 is a substantially rectangular shape, However, Other shapes, such as a semicircle shape, may be sufficient.
Further, in this embodiment, as the rotational force transmission mechanism, a convex portion is provided on the drug container 30 side and a concave portion that engages with the convex portion is provided on the adapter 4 side. A concave portion may be provided on the side, and a convex portion that engages with the concave portion may be provided on the adapter side. Furthermore, you may provide the convex part and recessed part which mutually engage in both a chemical | medical agent container and an adapter.

次に、本発明の薬剤調製用具１の作用を図１５ないし図１８を用いて説明する。
本発明の薬剤投与具は、図１５に示すように、アダプタ４が外筒２０に装着された状態となっており、プランジャ５も装着された状態となっている。そして、プレフィルドシリンジ２および薬剤容器３より、それぞれの封止部材６，７を離脱し、外筒２０に装着されたアダプタ４の薬剤容器接続部４２と、薬剤容器３０の筒先部３５を向かい合わせた状態を図１５に示す。
なお、この状態において、アダプタ４および薬剤容器３０には、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部との接続は不能である。よって、この時点では、プレフィルドシリンジ２、薬剤収納済薬剤容器３のいずれにも、他の医療用具のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部を接続することはできない。したがって、プレフィルドシリンジ２内の医療用液体１１および薬剤収納済薬剤容器３内の薬剤１０が直接投与されることはない。 Next, the operation of the drug preparation device 1 of the present invention will be described with reference to FIGS.
As shown in FIG. 15, the drug administration device of the present invention is in a state where the adapter 4 is attached to the outer cylinder 20, and the plunger 5 is also attached. Then, the respective sealing members 6 and 7 are detached from the prefilled syringe 2 and the drug container 3, and the drug container connection part 42 of the adapter 4 attached to the outer cylinder 20 and the cylinder tip part 35 of the drug container 30 face each other. The state is shown in FIG.
In this state, the adapter 4 and the drug container 30 cannot be connected to a female connection portion having a female luer taper that conforms to the ISO standard of other medical devices. Therefore, at this time, a female connection portion having a female luer taper conforming to the ISO standard of other medical devices cannot be connected to either the prefilled syringe 2 or the medicine container 3 with medicine. Accordingly, the medical liquid 11 in the prefilled syringe 2 and the medicine 10 in the medicine container 3 are not directly administered.

そして、図１６に示すように、薬剤容器３０を外筒２０に装着されているアダプタ４の薬剤容器接続部４２に接続する。両者の接続は、アダプタ４の薬剤容器接続部４２が、薬剤容器３０のカラー部３３内に収納されるように、いずれかを押し込むこと（例えば、図１５に示す矢印方向に、薬剤容器を押す）により、行われる。そして、両者の接続が、完了すると、図１６に示すように、薬剤容器３０の突出部３６が、アダプタ４の溝部４６に収納され、薬剤容器３０の突出部３６のリブ３７が、アダプタ４の溝部４６の凹部４７に収納され、係合した状態となる。 Then, as shown in FIG. 16, the medicine container 30 is connected to the medicine container connecting portion 42 of the adapter 4 attached to the outer cylinder 20. For the connection between them, either one is pushed so that the medicine container connecting portion 42 of the adapter 4 is accommodated in the collar portion 33 of the medicine container 30 (for example, the medicine container is pushed in the direction of the arrow shown in FIG. 15). ). When the connection between the two is completed, as shown in FIG. 16, the protruding portion 36 of the drug container 30 is housed in the groove 46 of the adapter 4, and the rib 37 of the protruding portion 36 of the drug container 30 is connected to the adapter 4. It is stored in the recessed portion 47 of the groove portion 46 and is in an engaged state.

そして、ガスケット８に装着されたプランジャ５を外筒２０の基端方向に引くことにより、薬剤容器３０内が陰圧状態となり、図１７に示すように、ガスケット３２が移動するとともに、薬剤１０が外筒２０内に流入する。そして、必要により、薬剤容器３０が接続されたまま、シリンジ２を振り、薬剤を医療用液体に溶解または混合する。 Then, by pulling the plunger 5 attached to the gasket 8 in the proximal direction of the outer cylinder 20, the inside of the medicine container 30 is in a negative pressure state, and as shown in FIG. It flows into the outer cylinder 20. Then, if necessary, the syringe 2 is shaken while the drug container 30 is connected, and the drug is dissolved or mixed in the medical liquid.

この実施例では、薬剤容器３０とアダプタ４は、薬剤容器３０にて付与した回転力をアダプタ４に伝達可能な回転力伝達機構を備えている。このため、アダプタではなく、薬剤容器を回転させることにより、アダプタ４を回転させることができかつ、分離規制機構を有するため、回転中における薬剤容器３０とアダプタ４の分離もない。
図１６に示す矢印方向に、薬剤容器３０を回転させることにより、アダプタ４は、薬剤容器３０とともに回転し、外筒２０よりアダプタ４は、薬剤容器３０とともに離脱する。特に、この実施例では、アダプタ４と外筒２０とは螺合により接続されていているので、アダプタ４は、外筒２０より確実に離脱する。そして、アダプタ４の離脱により、図１８に示すように、外筒２０のノズル部２２が露出する。ノズル部２２は、ＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部に接続可能（この実施例のものでは、ＩＳＯ規格に適合したオスルアーテーパーを有するノズル部）であるので、外筒２０と他の医療用具（例えば、注射針）のＩＳＯ規格に適合したメスルアーテーパーを有するメス型接続部との接続が可能となり、薬剤１２の投与準備が完了する。
本発明の薬剤調製用具では、プレフィルドシリンジに薬剤容器に接続することなく、投与準備が完了しないので、プレフィルドシリンジ内の医療用液体に薬剤容器内の薬剤が混合されないまま投与するおそれを低減することができる。 In this embodiment, the medicine container 30 and the adapter 4 are provided with a rotational force transmission mechanism capable of transmitting the rotational force applied by the medicine container 30 to the adapter 4. For this reason, the adapter 4 can be rotated by rotating the drug container instead of the adapter, and since the separation regulating mechanism is provided, the drug container 30 and the adapter 4 are not separated during rotation.
By rotating the drug container 30 in the direction of the arrow shown in FIG. 16, the adapter 4 rotates together with the drug container 30, and the adapter 4 is detached from the outer cylinder 20 together with the drug container 30. In particular, in this embodiment, since the adapter 4 and the outer cylinder 20 are connected by screwing, the adapter 4 is reliably detached from the outer cylinder 20. As the adapter 4 is detached, the nozzle portion 22 of the outer cylinder 20 is exposed as shown in FIG. Since the nozzle portion 22 can be connected to a female connection portion having a female luer taper conforming to the ISO standard (in this embodiment, the nozzle portion having a male luer taper conforming to the ISO standard), the outer cylinder 20 Can be connected to a female connector having a female luer taper conforming to the ISO standard of other medical devices (for example, injection needles), and preparation for administration of the drug 12 is completed.
In the drug preparation device of the present invention, since preparation for administration is not completed without connecting the prefilled syringe to the drug container, the risk of administering the drug in the drug container without being mixed with the medical liquid in the prefilled syringe is reduced. Can do.

本発明は上記した例に限られず、本発明の主旨の範囲内で適宜変更が可能である。例えば、薬剤収納済薬剤容器３としては、薬剤容器ガスケットを持たないものとしてもよい。この場合、プレフィルドシリンジが内部に減圧空間を有するものを用いることにより、また、薬剤容器が変形可能なものとすることが考えられる。 The present invention is not limited to the above-described example, and can be appropriately changed within the scope of the gist of the present invention. For example, the medicine container 3 containing medicine may not have a medicine container gasket. In this case, it is conceivable that the prefilled syringe can be deformed by using a prefilled syringe having a reduced pressure space inside.

１薬剤調製用具
２プレフィルドシリンジ
３薬剤収納済薬剤容器
４アダプタ
５プランジャ 1 Drug Preparation Tool 2 Prefilled Syringe 3 Drug Stored Drug Container 4 Adapter 5 Plunger

Claims

An outer cylinder for a syringe having a nozzle portion at the tip which is a male connection portion that can be connected to a female connection portion having a female luer taper conforming to the ISO standard, and a slidable gasket housed in the outer tube A pre-filled comprising: a plunger attached to or attachable to a proximal end of the gasket; an adapter detachably attached to the distal end portion of the outer cylinder; and a medical fluid filled in the outer cylinder. A drug preparation tool comprising a syringe, a drug container having a tube tip portion with an open tip, and a drug container with a drug stored in the drug container communicating with the tube tip portion ,
The adapter is a cylindrical body that penetrates from one end to the other end, and is provided with an outer cylinder connecting portion that can be liquid-tightly connected to the distal end portion of the outer cylinder on one end side, and the drug container on the other end side. A drug container connecting portion that can be liquid-tightly connected to the tube tip portion and cannot be connected to the female connection portion, a lumen penetrating from the one end to the other end, and communicating with the lumen An opening on the outer tube connecting part side, and an opening on the drug container connecting part side communicating with the lumen,
The drug preparation tool includes an outer cylinder sealing member that is attached to the opening on the drug container connection part side of the adapter and seals the opening on the drug container connection part side in a liquid-tight manner,
In a state where the medicine preparation tool is not used, the adapter is attached to the distal end portion of the outer cylinder, and the outer container sealing member attached to the adapter allows the medicine container connecting part side The opening of is liquid tightly sealed,
The adapter is attached to the outer cylinder , and in a state where the sealing member is removed , obstructs the connection of the nozzle part of the outer cylinder to the female connection part,
The outer cylinder to which the adapter is attached can be connected to the tube tip portion of the drug container using the drug container connection portion of the adapter , and by connection using the drug container connection portion of the adapter, The outer cylinder and the tube tip of the drug container communicate with each other, allow the drug to flow into the outer cylinder, and after connection, the drug container can be detached from the outer cylinder together with the adapter, The medicine preparation tool, wherein the nozzle part of the outer cylinder is exposed by detachment of the adapter, and the nozzle part can be connected to the female connection part.

The said outer cylinder is provided with the outer cylinder side screwing part, The said outer cylinder connection part of the said adapter is provided with the adapter side screwing part which can be screwed together with the said outer cylinder side screwing part. Drug preparation tool.

The said adapter is a chemical | medical agent preparation tool of Claim 1 or 2 provided with the annular rib provided in the inner surface of the said adapter, and contacting with the outer surface of the said nozzle part of the said outer cylinder in a liquid-tight state.

The medicine preparation tool according to any one of claims 1 to 3 , wherein the medicine container and the adapter include a rotational force transmission mechanism capable of transmitting the rotational force applied by the medicine container to the adapter.

Said drug container and the adapter, after connection to the adapter of the medicament container, according to any one of the 4 claims 1 comprises a separation restricting mechanism for restricting the separation of the medication container from said adapter Drug preparation tool.

The tip of the tube tip portion of the drug container can enter the drug container connection portion of the adapter, and the adapter is provided on the inner surface of the adapter, and is liquid-tight with the outer surface of the tube tip portion of the drug container. The medicine preparation device according to any one of claims 1 to 5 , further comprising an annular rib that can be contacted in a state.

The said outer cylinder and the said adapter are the chemical | medical agent preparation tools in any one of Claim 1 thru | or 6 provided with the detachment | leave control mechanism which controls detachment | leave from the said outer cylinder of the said adapter.

The medicine preparation tool according to any one of claims 1 to 7 , wherein the medicine container connection portion of the adapter cannot be connected to the female connection portion.

  An outer cylinder for a syringe having a nozzle portion, which is a male connection portion that can be connected to a female connection portion having a female luer taper conforming to the ISO standard, and a detachable attachment to the distal end portion of the outer cylinder. An adapter, a drug container having a tube tip portion with an open tip, and a method of using a drug preparation tool comprising a drug housed in the drug container communicating with the tube tip portion,
  The adapter is a cylindrical body that penetrates from one end to the other end, and is provided with an outer cylinder connecting portion that can be liquid-tightly connected to the distal end portion of the outer cylinder on one end side, and the drug container on the other end side. A liquid container can be connected in a liquid-tight manner to the tube tip, and a drug container connecting portion that cannot be connected to the female connecting portion,
  In a state where the adapter is attached to the outer cylinder, the adapter inhibits connection of the nozzle part of the outer cylinder to the female connection part, and the drug container connection part and the cylinder tip part of the drug container Can be detached from the outer cylinder together with the drug container,
  A medical liquid is filled therein, a gasket is housed therein, and the outer cylinder is provided with the adapter not connected to the drug container attached to the distal end portion through the outer cylinder connecting portion,
  The tube tip part of the drug container is connected to the drug container connection part of the adapter mounted on the outer cylinder, and the outer cylinder and the drug container are connected by connection using the drug container connection part of the adapter. Communicating the tube tip,
  Flowing the drug from the drug container into the outer cylinder, dissolving or mixing the drug in the medical liquid;
  Use of a drug preparation tool, wherein the adapter is detached together with the drug container from the outer cylinder containing the drug dissolved or mixed in the medical liquid to expose the nozzle part of the outer cylinder. Method.