JP5416529B2 - Drug administration device and drug administration device with drug container installed - Google Patents

Drug administration device and drug administration device with drug container installed Download PDF

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JP5416529B2
JP5416529B2 JP2009225637A JP2009225637A JP5416529B2 JP 5416529 B2 JP5416529 B2 JP 5416529B2 JP 2009225637 A JP2009225637 A JP 2009225637A JP 2009225637 A JP2009225637 A JP 2009225637A JP 5416529 B2 JP5416529 B2 JP 5416529B2
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puncture member
administration device
drug administration
drug
hollow needle
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等 沖原
美緒 廣瀬
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Terumo Corp
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Description

本発明は、プレフィルドシリンジを利用した薬剤投与具および薬剤容器装着済み薬剤投与具に関する。   The present invention relates to a drug administration device using a prefilled syringe and a drug administration device already loaded with a drug container.

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。薬剤溶解液充填プレフィルドシリンジの粉末製剤収納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。また、投与準備作業は、医療従事者だけでなく自己注射を必要とする患者自身によって行われる場合がある。特に患者による投与準備は、汚染が危惧される環境、不安定な場所で行われる可能性が少なくない。また、粉末製剤の溶解作業を失念し、プレフィルドシリンジ内の溶解液のみの投与、液漏れや接続部の外れなどを引き起こすおそれがある。   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. Generally, a metal needle is used to connect a pre-filled syringe filled with a drug solution to a drug container containing a powder formulation. Recently, a product using a dedicated connector has also been proposed. In addition, the administration preparation work may be performed not only by medical personnel but also by the patient himself who needs self-injection. In particular, patient preparations are often performed in environments where contamination is a concern and in unstable locations. Moreover, there is a risk of forgetting the dissolution work of the powder preparation, causing administration of only the solution in the prefilled syringe, liquid leakage, disconnection of the connection portion, and the like.

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を具えた円形又は環状のシールリップ54を具えている。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具えていることが判るであろう。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を具えている。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。
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具えている。
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. Patent No. 6,053,831, 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 is provided. It will be appreciated that the proximal end of the tubular transfer member 46 includes a plurality of seal lips, such as the 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.
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2007−98109号公報(特許文献2)のものを提案している。
特許文献2の薬剤混注器具1は、ノズル部22を備える外筒2と、ガスケット5と、充填された薬剤8とからなるプレフィルドシリンジ10と、ノズル部に装着可能な混注用針3とからなる。ノズル部22は、内筒部23と、外筒部24と、外筒部の外面に設けられた外側リブ25を備え、内筒部の先端部の外径と外筒部の先端部の内径の差は、0.5mm〜1.5mmであり、外筒部の先端部の内径は、2〜3mmまたは6〜10mmとなっている。混注用針3は、針本体部31と、ノズル部22の外筒部24と内筒部23間に侵入可能な中筒部38と、内面にノズル部のリブ25と係合する内側リブ37を有する筒状部33と、混注用針3の先端より10〜25mm基端側の位置に設けられた側孔36を備えている。
Further, the applicant of the present application has proposed one disclosed in Japanese Patent Application Laid-Open No. 2007-98109 (Patent Document 2).
The medicine co-infusion apparatus 1 of Patent Document 2 includes an outer cylinder 2 provided with a nozzle portion 22, a gasket 5, a prefilled syringe 10 composed of a filled medicine 8, and a co-infusion needle 3 that can be attached to the nozzle portion. . The nozzle part 22 includes an inner cylinder part 23, an outer cylinder part 24, and an outer rib 25 provided on the outer surface of the outer cylinder part, and the outer diameter of the distal end part of the inner cylinder part and the inner diameter of the distal end part of the outer cylinder part Is 0.5 mm to 1.5 mm, and the inner diameter of the distal end portion of the outer cylinder portion is 2 to 3 mm or 6 to 10 mm. The mixed injection needle 3 includes a needle main body 31, a middle cylinder 38 that can enter between the outer cylinder 24 and the inner cylinder 23 of the nozzle 22, and an inner rib 37 that engages with the rib 25 of the nozzle on the inner surface. And a side hole 36 provided at a position 10 to 25 mm proximal from the distal end of the mixed injection needle 3.

特許第4216466号公報Japanese Patent No. 4216466 特開2007−98109号公報JP 2007-98109 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具えているため、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。
また、特許文献2のものでは、引用文献1のような注射器内の薬剤溶解液のみの誤投与を起こす可能性はないが、接続されるのが混注用針のみであるため、投与形態が輸液容器内への混合に特定される。
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、薬剤が収納された薬剤容器(バイアル)内へのプレフィルドシリンジの接続操作が容易であり、かつ、シリンジ内に回収された薬剤溶解済み医療用液体の直接投与、間接投与など投与形態を選択可能なプレフィルドシリンジを利用した薬剤投与具および薬剤容器装着済み薬剤投与具を提案するものである。
In US Pat. No. 6,057,059, the syringe is manufactured according to ISO standards and the nozzle comprises a female luer lock or female thread 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.
Moreover, in the thing of patent document 2, although there is no possibility of causing misadministration of only the drug solution in the syringe as in the cited document 1, since only the mixed injection needle is connected, the administration form is infusion. Specific to mixing in a container.
An object of the present invention is to prevent only a medical liquid filled in a prefilled syringe from being administered, to facilitate the operation of connecting the prefilled syringe into a drug container (vial) containing a drug, and The present invention proposes a drug administration device using a prefilled syringe and a drug administration device already loaded with a drug container capable of selecting an administration mode such as direct administration and indirect administration of a medical solution dissolved in a syringe.

上記目的を達成するものは、以下のものである。
(1)外筒本体部と、該外筒本体部の先端部に設けられ先端が開口し、かつ、ISO規格に適合したノズル部への接続部を有する医療用具の前記接続部への接続が不能な形態を有するノズル部を備える外筒と、前記ノズル部を封止する封止部材と、前記外筒内に摺動可能に収納されたガスケットと、該ガスケットの後端に取り付けられたもしくは取付可能な押子と、前記外筒内に充填された医療用液体とからなるプレフィルドシリンジと、開口部を有する容器本体と該容器本体の前記開口部を封止するシール部材と前記容器本体内に収納された薬剤とからなる薬剤容器の前記シール部材にてシールされた前記開口部に接続可能なアダプターとからなる薬剤投与具であって、前記アダプターは、一端側に設けられ、ISO規格に適合したノズル部への接続部を有する医療用具の前記接続部に接続可能な医療用具接続部と、他端側に設けられ、前記プレフィルドシリンジの前記ノズル部が係合可能なシリンジ接続部とを備えるコネクターと、一端に前記薬剤容器の前記シール部材を貫通可能な刃先部を有する中空針状部と、他端側に設けられ、前記コネクターを着脱可能に接続するコネクター装着部と、前記中空針状部の中央部より他端側を被包する筒状のカラー部とを備える穿刺部材と、前記シール部材にてシールされた前記開口部に接続可能な薬剤容器装着部と、該装着部より延び、かつ、前記穿刺部材の前記中空針状部が内側にかつ前記カラー部が外側を移動可能な中空針状部収納用筒状部とを有するガイド部材とからなり、前記穿刺部材と前記ガイド部材は、前記コネクターに前記シリンジを接続した後、前記シリンジを押し込むことにより、前記穿刺部材は前記ガイド部材内を進行し、前記薬剤容器の前記シール部材を刺通するものであり、かつ、前記穿刺部材と前記ガイド部材は、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部を備えている薬剤投与具。
What achieves the above object is as follows.
(1) Connection of the medical device having the outer cylinder main body part and the connection part to the nozzle part that is provided at the distal end part of the outer cylinder main body part and that is open at the distal end and conforms to the ISO standard to the connection part. An outer cylinder provided with a nozzle part having an incapable form, a sealing member for sealing the nozzle part, a gasket slidably accommodated in the outer cylinder, and attached to the rear end of the gasket, or A prefilled syringe comprising a pusher that can be attached, a medical liquid filled in the outer cylinder, a container body having an opening, a seal member for sealing the opening of the container body, and the inside of the container body A medicine administration device comprising an adapter connectable to the opening sealed by the sealing member of a medicine container comprising medicine contained in the medicine container, wherein the adapter is provided on one end side and complies with ISO standards. Suitable nozzle A connector comprising: a medical device connection portion connectable to the connection portion of the medical device having a connection portion; and a syringe connection portion provided on the other end side and engageable with the nozzle portion of the prefilled syringe; A hollow needle-like portion having a blade edge portion capable of penetrating the seal member of the drug container at one end; a connector mounting portion provided on the other end side to removably connect the connector; and a center of the hollow needle-like portion A puncture member comprising a cylindrical collar portion encapsulating the other end side from the portion, a drug container mounting portion connectable to the opening sealed by the seal member, and extending from the mounting portion; The hollow needle-like portion of the puncture member comprises a guide member having a hollow needle-like portion storage tubular portion that is movable inward and the collar portion is movable outward, and the puncture member and the guide member are Connector After the syringe is connected, by pushing the syringe, the puncture member advances in the guide member and pierces the seal member of the drug container, and the puncture member and the guide member Is a drug administration device that includes an engagement portion that is engaged after the puncture member completes piercing of the drug container into the seal member and prevents the puncture member from being detached from the guide member.

(2)前記ガイド部材は、前記中空状針状部収納用筒状部の外方に位置し、かつ、前記薬剤容器装着部より前記中空状針状部収納用筒状部の端部方向に延びる外側ガイド部を備え、前記穿刺部材の前記カラー部は、前記外側ガイド部と前記中空針状部収納用筒状部との間隙を移動するものであり、かつ、前記ガイド部材の前記外側ガイド部と前記穿刺部材が、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部を備えている上記(1)に記載の薬剤投与具。
(3)前記穿刺部材は、前記カラー部の先端部の内面に設けられた突出部を備え、前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられ、前記穿刺部材の前記突出部を摺動可能に収納しかつ前記筒状部の軸方向かつ前記薬剤容器装着部側より前記中空状針状部収納用筒状部の端部方向に延びる軸方向溝部と、該軸方向溝部内かつ前記装着部側に位置し、前記穿刺部材の突出部と係合可能な係合部を備えており、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部は、前記穿刺部材の突出部と前記ガイド部材の前記軸方向溝部内の前記係合部とにより構成されているものである上記(1)または(2)に記載の薬剤投与具。
(2) The guide member is located outward of the hollow needle-shaped portion storage tubular portion, and extends from the drug container mounting portion toward the end of the hollow needle-shaped portion storage tubular portion. An outer guide portion that extends, and the collar portion of the puncture member moves in a gap between the outer guide portion and the hollow needle-like portion storage tubular portion, and the outer guide of the guide member And the puncture member is provided with an engagement portion that is engaged after the puncture member completes puncture of the drug container to the seal member and suppresses detachment of the puncture member from the guide member. The drug administration device according to 1).
(3) The puncture member includes a protruding portion provided on an inner surface of a distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion. An axial groove that slidably accommodates the projecting portion and extends in the axial direction of the tubular portion and from the side of the medicine container mounting portion toward the end of the tubular portion for housing the hollow needle-like portion; An engaging portion that is located in the directional groove and on the mounting portion side and is engageable with the protruding portion of the puncture member, and is engaged after the puncture member completes piercing of the drug container into the seal member And the engaging part which suppresses detachment | leave from the said guide member of the said puncture member is comprised by the protrusion part of the said puncture member, and the said engaging part in the said axial groove part of the said guide member. The drug administration device according to (1) or (2) above.

(4)前記穿刺部材は、前記カラー部の先端部の内面に設けられた突出部を備え、前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられ、前記穿刺部材の前記突出部を摺動可能に収納しかつ前記筒状部の軸方向かつ前記薬剤容器装着部側より前記中空状針状部収納用筒状部の端部方向に延びる軸方向溝部と、該軸方向溝部と連続し、前記筒状部の周方向に延びかつ前記穿刺部材の前記突出部を摺動可能に収納する周方向溝部とを備え、前記穿刺部材の前記突出部は、前記ガイド部材の前記周方向溝部内に位置し、前記穿刺部材の前記カラー部に対する周方向への移動を許容し、かつ、軸方向への移動が規制された状態となっている上記(1)ないし(3)のいずれかに記載の薬剤投与具。
(5)前記穿刺部材は、該穿刺部材を前記ガイド部材の前記中空針状部収納用筒状部の周方向に回転させることにより、前記穿刺部材の前記突出部が前記中空針状部収納用筒状部の軸方向溝部内に移動し、前記穿刺部材の前記ガイド部材の前記装着部方向への移動が可能となるものである上記(4)に記載の薬剤投与具。
(6)前記外筒は、前記ノズル部に設けられた係合用外側リブを備え、前記コネクターは、外側筒状部と該外側筒状部に形成されるとともに、前記係合用外側リブと係合可能な係合用内側リブとを備え、前記穿刺部材の前記突出部を前記ガイド部材の前記周方向溝部から離脱させるための回転方向は、前記外筒のノズル部の前記係合用外側リブを前記コネクターの前記外側筒状部の係合用内側リブとを係合させるための回転方向と同じである上記(5)に記載の薬剤投与具。
(7)前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部は、前記外側ガイド部の自由端側の内面に設けられたリブと、前記穿刺部材の前記コネクター装着部側に設けられ、前記リブと係合する開口部もしくは凹部により構成されている上記(2)ないし(6)のいずれかに記載の薬剤投与具。
(8)前記外側ガイド部は、向かい合うように2つ設けられており、かつ、それぞれの前記自由端側の内面に前記リブが設けられており、前記穿刺部材は、前記コネクター装着部側に向かい合うように設けられ、かつ、前記リブと係合する開口部もしくは凹部を備えている上記(7)に記載の薬剤投与具。
(9)前記外筒のノズル部は、前記外筒本体部の先端面より外方に突出する内筒部と、該内筒部を被包するように設けられた外筒部と、該外筒部の外面に設けられた係合用外側リブを備え、前記コネクターは、前記ノズル部の前記内筒部内に侵入可能な内側筒状部と、前記外筒部を収納可能かつ内面に前記係合用外側リブと係合可能な係合用内側リブとを有する外側筒状部とを備えている上記(1)ないし(8)のいずれかに記載の薬剤投与具。
(4) The puncture member includes a protruding portion provided on an inner surface of a tip portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like storage cylindrical portion. An axial groove that slidably accommodates the projecting portion and extends in the axial direction of the tubular portion and from the side of the medicine container mounting portion toward the end of the tubular portion for housing the hollow needle-like portion; A circumferential groove portion that is continuous with the directional groove portion, extends in the circumferential direction of the tubular portion, and slidably accommodates the protruding portion of the puncture member, wherein the protruding portion of the puncture member is Said (1) thru | or (3) which is located in the said circumferential groove part, is a state which permitted the movement to the circumferential direction with respect to the said collar part of the said puncture member, and was restricted to the movement to an axial direction. The drug administration device according to any one of 1.
(5) The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member is for storing the hollow needle-like portion. The drug administration device according to (4) above, which moves into the axial groove portion of the tubular portion and enables the puncture member to move in the direction of the mounting portion of the guide member.
(6) The outer cylinder includes an outer rib for engagement provided in the nozzle portion, and the connector is formed on the outer cylindrical portion and the outer cylindrical portion, and is engaged with the outer rib for engagement. An inner rib for engagement, and a rotation direction for detaching the protruding portion of the puncture member from the circumferential groove of the guide member, the outer rib for engagement of the nozzle portion of the outer cylinder being the connector The drug administration device according to (5), wherein the rotation direction for engaging the engaging inner rib of the outer cylindrical portion is the same.
(7) The engaging portion that suppresses the puncture member from being detached from the guide member is provided on the inner surface of the outer guide portion on the free end side and on the connector mounting portion side of the puncture member. The drug administration device according to any one of the above (2) to (6), which is constituted by an opening or a recess that engages with the rib.
(8) The two outer guide portions are provided so as to face each other, and the ribs are provided on the inner surfaces of the free end sides, and the puncture member faces the connector mounting portion side. The drug administration device according to (7), which is provided with an opening or a recess that is provided to engage with the rib.
(9) The nozzle portion of the outer cylinder includes an inner cylinder portion protruding outward from a front end surface of the outer cylinder main body portion, an outer cylinder portion provided so as to enclose the inner cylinder portion, An outer rib for engagement provided on an outer surface of the cylindrical portion; and the connector includes an inner cylindrical portion that can enter the inner cylindrical portion of the nozzle portion; The drug administration device according to any one of (1) to (8), further including an outer cylindrical portion having an engagement inner rib that can be engaged with the outer rib.

(10)前記ノズル部の前記内筒部の先端部の外径と前記外筒部の先端部の内径の差は、0.5mm〜1.5mmであり、前記外筒部の先端部の内径は、2〜3mmまたは6〜10mmである上記(9)に記載の薬剤投与具。
(11)前記コネクターと前記穿刺部材は、前記穿刺部材の前記コネクター装着部に装着された前記コネクターが前記穿刺部材に対して回転することを規制する回転規制部を備えている上記(1)ないし(10)のいずれかに記載の薬剤投与具。
(12)前記穿刺部材は、該穿刺部材を前記ガイド部材の前記中空針状部収納用筒状部の周方向に回転させることにより、前記穿刺部材の前記突出部が前記中空針状部収納用筒状部の前記軸方向溝部内に移動し、前記穿刺部材の前記ガイド部材の前記装着部方向への移動が可能となるものである上記(3)ないし(11)のいずれかに記載の薬剤投与具。
(13)前記穿刺部材を回転させる前記カラー部の周方向は、前記外筒のノズル部の前記係合用外側リブを前記コネクターの前記外側筒状部の係合用内側リブとを係合させるための回転方向と同じである上記(12)に記載の薬剤投与具。
(14)前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられた前記周方向溝部と連続し、前記中空針状部収納用筒状部の自由端まで延びかつ前記穿刺部材の前記突出部を摺動可能に収納する誘導用軸方向溝部を備えている上記(4)ないし(13)のいずれかに記載の薬剤投与具。
(15)前記ガイド部材は、前記薬剤容器装着部に設けられ、該装着部に易変形性を付与するためのスリットを備えている上記(1)ないし(14)のいずれかに記載の薬剤投与具。
(16)上記(1)ないし(15)のいずれかに記載の薬剤投与具と、前記薬剤容器とからなり、かつ、該薬剤投与具が、前記薬剤容器装着部により前記薬剤容器に装着された状態となっている薬剤容器装着済み薬剤投与具。
(10) The difference between the outer diameter of the distal end portion of the inner cylindrical portion of the nozzle portion and the inner diameter of the distal end portion of the outer cylindrical portion is 0.5 mm to 1.5 mm, and the inner diameter of the distal end portion of the outer cylindrical portion Is 2 to 3 mm or 6 to 10 mm.
(11) The connector and the puncture member may include a rotation restricting portion that restricts rotation of the connector attached to the connector attachment portion of the puncture member relative to the puncture member. (10) The drug administration device according to any one of (10).
(12) The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member is for storing the hollow needle-like portion. The drug according to any one of (3) to (11), wherein the drug moves into the axial groove portion of the tubular portion, and the puncture member can move in the direction of the mounting portion of the guide member. Administration device.
(13) In the circumferential direction of the collar portion for rotating the puncture member, the outer rib for engagement of the nozzle portion of the outer cylinder is engaged with the inner rib for engagement of the outer cylindrical portion of the connector. The drug administration device according to (12), which is the same as the rotation direction.
(14) The guide member is continuous with the circumferential groove provided on the outer surface of the hollow needle-like storage cylindrical portion, extends to a free end of the hollow needle-like storage cylindrical portion, and the puncture The drug administration device according to any one of (4) to (13), further comprising a guiding axial groove portion that slidably accommodates the protruding portion of the member.
(15) The drug administration according to any one of (1) to (14), wherein the guide member is provided in the drug container mounting portion and includes a slit for imparting easy deformability to the mounting portion. Ingredients.
(16) The medicine administration device according to any one of (1) to (15) above and the medicine container, and the medicine administration device is attached to the medicine container by the medicine container mounting portion. A drug administration device with a drug container already attached.

本発明の薬剤投与具は、ISO規格に適合したノズル部への接続部を有する医療用具への接続が不能なプレフィルドシリンジと、薬剤容器への装着部を有するアダプターとからなり、アダプターは、プレフィルドシリンジのノズル部を接続可能かつISO規格に適合したノズル部への接続部を有する医療用具に接続するための医療用具接続部と、プレフィルドシリンジのノズル部への装着部を備えるコネクターと、中空針状部を備え、コネクターを着脱可能に接続する穿刺部材と、薬剤容器装着部と穿刺部材の中空針状部を内側移動可能な中空針状部収納用筒状部を有するガイド部材とからなる。そして、穿刺部材とガイド部材は、コネクターにシリンジを接続し、シリンジを押し込むことにより、穿刺部材はガイド部材内を進行し、薬剤容器の前記シール部材を刺通するものであり、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。
特に、本発明の薬剤投与具では、プレフィルドシリンジとして、ISO規格に適合したノズル部への接続部を有する医療用具への接続が不能なものとしているため、このシリンジには、一般的な投与手段である注射針ハブ、三方活栓のポートへの接続が不能であるため、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可能性は極めて少ない。そして、薬剤剤が収納された薬剤容器に本発明の薬剤投与具のアダプターを装着した後、アダプターのコネクターにプレフィルドシリンジを装着し、プレフィルドシリンジを押し込むことにより、穿刺部材はガイド部材内を進行し、薬剤容器の前記シール部材を刺通し、その後、プレフィルドシリンジのプランジャーを押圧することにより、シリンジ内の医療用液体を薬剤容器内に注入することができる。そして、シリンジのプランジャーを引くことにより、シリンジ内に薬剤が溶解した医療用液体(薬液)を回収することができる。さらに、穿刺部材による薬剤容器のシール部材への刺通完了後に係合部により、穿刺部材のガイド部材からの離脱が抑制されているので、上記の医療用液体の薬剤容器への注入およびシリンジへの回収作業が容易である。また、アダプターのコネクターはシリンジのノズル部に係合しているため、アダプターよりシリンジを離脱させると、シリンジのノズル部にコネクターが装着した状態となるため、コネクターのノズル部を用いることにより、一般的な投与手段である注射針ハブ、三方活栓のポートへの接続が可能となり、シリンジ内に回収された薬剤溶解済み医療用液体を直接投与、間接投与など任意の投与形態による投与が可能となる。
The drug administration device of the present invention comprises a prefilled syringe that cannot be connected to a medical device having a connection part to a nozzle part that conforms to the ISO standard, and an adapter that has a mounting part to a drug container. A medical device connection portion for connecting to a medical device having a connection portion to a nozzle portion that can connect the nozzle portion of the syringe and conforms to the ISO standard, a connector having a mounting portion to the nozzle portion of the prefilled syringe, and a hollow needle And a guide member having a tubular portion for accommodating a hollow needle-like portion that can move inside the hollow needle-like portion of the puncture member. The puncture member and the guide member connect the syringe to the connector and push the syringe, whereby the puncture member advances in the guide member and pierces the seal member of the drug container. The puncture member and the guide member The member includes an engaging portion that is engaged after the puncture member completes the piercing of the drug container to the seal member and suppresses the puncture member from being detached from the guide member.
In particular, in the drug administration device of the present invention, as a prefilled syringe, it is impossible to connect to a medical device having a connection portion to a nozzle portion conforming to the ISO standard. Since the connection to the injection needle hub and the port of the three-way stopcock is impossible, there is very little possibility that the medical liquid in the prefilled syringe is directly administered. And after attaching the adapter of the medicine administration device of the present invention to the medicine container in which the medicine is stored, the prefilled syringe is attached to the connector of the adapter, and the prefilled syringe is pushed in so that the puncture member advances in the guide member. The medical liquid in the syringe can be injected into the drug container by piercing the seal member of the drug container and then pressing the plunger of the prefilled syringe. Then, by pulling the plunger of the syringe, it is possible to recover the medical liquid (chemical solution) in which the drug is dissolved in the syringe. Furthermore, since the puncture member is prevented from being detached from the guide member by the engaging portion after the puncture member completes the piercing of the drug container to the seal member, the medical liquid is injected into the drug container and into the syringe. Is easy to collect. In addition, since the connector of the adapter is engaged with the nozzle part of the syringe, when the syringe is detached from the adapter, the connector is attached to the nozzle part of the syringe. Can be connected to an injection needle hub or three-way stopcock port, which is a typical administration means, and can be administered by any administration form such as direct administration or indirect administration of the drug-dissolved medical fluid collected in the syringe .

図1は、本発明の薬剤投与具を用いた薬剤容器装着済み薬剤投与具の外観図である。FIG. 1 is an external view of a drug administration device equipped with a drug container using the drug administration device of the present invention. 図2は、本発明の薬剤投与具のアダプターを装着した状態の薬剤容器の正面図である。FIG. 2 is a front view of the drug container in a state where the adapter of the drug administration device of the present invention is mounted. 図3は、図2に示した本発明の薬剤投与具のアダプターを装着した状態の薬剤容器の右側面図である。FIG. 3 is a right side view of the drug container with the adapter of the drug administration device of the present invention shown in FIG. 2 attached. 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、本発明の薬剤投与具のアダプターの説明図である。FIG. 5 is an explanatory diagram of an adapter of the drug administration device of the present invention. 図6は、本発明の薬剤投与具のアダプターの説明図である。FIG. 6 is an explanatory diagram of the adapter of the drug administration device of the present invention. 図7は、本発明の薬剤投与具のアダプターの説明図である。FIG. 7 is an explanatory diagram of an adapter of the drug administration device of the present invention. 図8は、本発明の薬剤投与具のアダプターに用いられるコネクターの正面図である。FIG. 8 is a front view of a connector used in the adapter of the drug administration device of the present invention. 図9は、図8のコネクターの右側面図である。9 is a right side view of the connector of FIG. 図10は、図8のB−B線断面図である。10 is a cross-sectional view taken along line BB in FIG. 図11は、図8のコネクターの底面図である。FIG. 11 is a bottom view of the connector of FIG. 図12は、図8のコネクターの平面図である。FIG. 12 is a plan view of the connector of FIG. 図13は、本発明の薬剤投与具のアダプターに用いられる穿刺部材の正面図である。FIG. 13 is a front view of a puncture member used in the adapter of the drug administration device of the present invention. 図14は、図13の穿刺部材の右側面図である。FIG. 14 is a right side view of the puncture member of FIG. 図15は、図13のC−C線断面図である。15 is a cross-sectional view taken along the line CC of FIG. 図16は、図13の穿刺部材の平面図である。FIG. 16 is a plan view of the puncture member of FIG. 図17は、図13の穿刺部材の底面図である。FIG. 17 is a bottom view of the puncture member of FIG. 図18は、本発明の薬剤投与具のアダプターに用いられるガイド部材の正面図である。FIG. 18 is a front view of a guide member used in the adapter of the drug administration device of the present invention. 図19は、図18のガイド部材の平面図である。FIG. 19 is a plan view of the guide member of FIG. 図20は、図18のガイド部材の底面図である。FIG. 20 is a bottom view of the guide member of FIG. 図21は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 21 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. 図22は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 22 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted thereon according to the present invention. 図23は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 23 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. 図24は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 24 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention. 図25は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 25 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted according to the present invention. 図26は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 26 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted thereon according to the present invention. 図27は、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を説明するための説明図である。FIG. 27 is an explanatory diagram for explaining the operation of the drug administration device and the drug administration device with the drug container mounted therein according to the present invention.

本発明の薬剤投与具および薬剤容器装着済み薬剤投与具を図面に示す実施例を用いて説明する。
本発明の薬剤投与具は、外筒本体部31と、外筒本体部31の先端部に設けられ先端が開口し、かつ、ISO規格に適合したノズル部への接続部を有する医療用具の前記接続部への接続が不能な形態を有するノズル部35を備える外筒30と、ノズル部35を封止する封止部材33と、外筒30内に摺動可能に収納されたガスケット34と、ガスケット34の後端に取り付けられたもしくは取付可能な押子32と、外筒30内に充填された医療用液体38とからなるプレフィルドシリンジ3と、開口部を有する容器本体41と容器本体41の開口部を封止するシール部材42と容器本体41内に収納された薬剤43とからなる薬剤容器4のシール部材42にてシールされた開口部に接続可能なアダプター2とからなる。
The drug administration device of the present invention and the drug administration device loaded with a drug container will be described with reference to the embodiments shown in the drawings.
The drug administration device of the present invention includes an outer cylinder main body 31 and a medical device having a connection portion to a nozzle portion that is provided at a distal end portion of the outer cylinder main body portion 31 and that has an open front end and conforms to ISO standards. An outer cylinder 30 including a nozzle part 35 having a configuration incapable of being connected to the connection part, a sealing member 33 for sealing the nozzle part 35, a gasket 34 slidably accommodated in the outer cylinder 30, A prefilled syringe 3 comprising a pusher 32 attached to or attachable to the rear end of the gasket 34, a medical liquid 38 filled in the outer cylinder 30, a container main body 41 having an opening, and a container main body 41 The adapter 2 is composed of a seal member 42 that seals the opening and a medicine 43 accommodated in the container body 41. The adapter 2 can be connected to the opening sealed by the seal member 42 of the medicine container 4.

アダプター2は、一端側に設けられ、ISO規格に適合したノズル部への接続部を有する医療用具に接続するための医療用具接続部72と、他端側に設けられ、プレフィルドシリンジ3のノズル部35が係合可能なシリンジ接続部とを備えるコネクター7と、一端に薬剤容器4のシール部材42を貫通可能な刃先部を有する中空針状部62と、他端側に設けられ、コネクター7を着脱可能に接続するコネクター装着部61と、中空針状部62の中央部より他端側を被包する筒状のカラー部63とを備える穿刺部材6と、シール部材42にてシールされた開口部に接続可能な薬剤容器装着部51と、装着部51より延び、かつ、穿刺部材6の中空針状部62が内側にかつカラー部63が外側を移動可能な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6とガイド部材5は、コネクター7にシリンジ3を接続し、シリンジ3を押し込むことにより、穿刺部材6はガイド部材5内を進行し、薬剤容器のシール部材を刺通するものである。そして、穿刺部材6とガイド部材5は、穿刺部材6による薬剤容器4のシール部材42への刺通完了後に係合し、穿刺部材6のガイド部材5からの離脱を抑制する係合部を備えている。
また、本発明の薬剤容器装着済み薬剤投与具1は、上述した薬剤容器を備えない薬剤投与具と、開口部を有する容器本体41と容器本体41の開口部を封止するシール部材42と容器本体41内に収納された薬剤を有する薬剤容器4とからなり、かつ、薬剤投与具が、薬剤容器装着部51にて薬剤容器4に装着された状態となっているものである。
The adapter 2 is provided on one end side, the medical device connection portion 72 for connecting to a medical device having a connection portion to the nozzle portion conforming to the ISO standard, and the nozzle portion of the prefilled syringe 3 provided on the other end side. A connector 7 provided with a syringe connection portion to which 35 can be engaged, a hollow needle-like portion 62 having a cutting edge portion that can penetrate the seal member 42 of the drug container 4 at one end, and the connector 7 Puncture member 6 including a connector mounting portion 61 that is detachably connected, and a cylindrical collar portion 63 that encloses the other end side from the central portion of the hollow needle-like portion 62, and an opening sealed by the seal member 42 A medicine container mounting part 51 connectable to the part, and a hollow needle-like part storage cylinder extending from the mounting part 51 and having a hollow needle-like part 62 of the puncture member 6 being movable inward and a collar part 63 being movable outward. Part 54 Consisting of Ido member 5.
The puncture member 6 and the guide member 5 connect the syringe 3 to the connector 7 and push the syringe 3 so that the puncture member 6 advances in the guide member 5 and pierces the seal member of the drug container. The puncture member 6 and the guide member 5 are engaged with each other after the puncture member 6 completes the piercing of the drug container 4 to the seal member 42 and suppresses the puncture member 6 from being detached from the guide member 5. ing.
The drug administration device 1 with the drug container mounted according to the present invention includes a drug administration device that does not include the above-described drug container, a container body 41 having an opening, a seal member 42 that seals the opening of the container body 41, and a container. The medicine container 4 has a medicine stored in the main body 41, and the medicine administration tool is attached to the medicine container 4 by the medicine container attaching portion 51.

本発明の薬剤容器装着済み薬剤投与具1は、図1ないし図10に示すように、薬剤投与具と、薬剤投与具5が接続された薬剤容器4とからなる。また、本発明の薬剤投与具は、ISO規格に適合したノズル部への接続部を有する医療用具への接続が不能なプレフィルドシリンジ3と、薬剤容器4への装着部を有するアダプター2とからなる。そして、アダプター2は、図1ないし図10に示すように、プレフィルドシリンジ3のノズル部35を接続可能なコネクター7と、中空針状部62を備え、コネクター7を接続可能な穿刺部材6と、薬剤容器装着部51と、穿刺部材6の中空針状部62を内側移動可能な中空針状部収納用筒状部54を有するガイド部材5とからなる。
図1は、本発明の薬剤投与具を用いた薬剤容器装着済み薬剤投与具の提供される状態の外観図であり、後述するように、穿刺部材6が中空針状部収納用筒状部54の下方に移動不能となっている状態を図示している。これに対して図2は、本発明の薬剤投与具のアダプターを装着した状態の薬剤容器の正面図を示すものであり、図1に対して、穿刺部材6が中空針状部収納用筒状部54の中心軸に対して約90度回転し、穿刺部材6が中空針状部収納用筒状部54の下方に移動可能の状態を図示している。
As shown in FIGS. 1 to 10, the drug administration device 1 with the drug container mounted according to the present invention includes a drug administration device and a drug container 4 to which a drug administration device 5 is connected. The drug administration device of the present invention includes a prefilled syringe 3 that cannot be connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard, and an adapter 2 that has a mounting portion to the drug container 4. . As shown in FIGS. 1 to 10, the adapter 2 includes a connector 7 to which the nozzle portion 35 of the prefilled syringe 3 can be connected, a hollow needle-like portion 62, and a puncture member 6 to which the connector 7 can be connected. It comprises a drug container mounting portion 51 and a guide member 5 having a hollow needle-like portion storage tubular portion 54 that can move inside the hollow needle-like portion 62 of the puncture member 6.
FIG. 1 is an external view of a state in which a drug administration device equipped with a drug container using the drug administration device of the present invention is provided. As will be described later, the puncture member 6 has a hollow needle-like portion storage tubular portion 54. The state which cannot move below is illustrated. On the other hand, FIG. 2 shows a front view of the drug container in a state in which the adapter of the drug administration device of the present invention is mounted. Compared to FIG. The state where the puncture member 6 is rotated about 90 degrees with respect to the central axis of the portion 54 and is movable below the hollow needle-like portion storage tubular portion 54 is illustrated.

最初に、プレフィルドシリンジ3について、図1、図23ないし図27を用いて説明する。
プレフィルドシリンジ3は、外筒本体部31と、外筒本体部31の先端部に設けられ先端が開口し、かつ、ISO規格に適合したノズル部への接続部を有する医療用具への接続が不能な形態を有するノズル部35を備える外筒30と、ノズル部35を封止する封止部材33(具体的には、取り外し可能なキャップ)と、外筒30内に摺動可能に収納されたガスケット34と、ガスケット34の後端に取り付けられたもしくは取付可能な押子32と、外筒30内に充填された医療用液体38とからなる。
外筒30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。
外筒30は、外筒本体部31と、外筒本体部31の先端部に設けられたノズル部35と、外筒本体部31の後端部に設けられたフランジを備える。
外筒本体部31は、ガスケット34を液密かつ摺動可能に収納するほぼ筒状の部分であり、ノズル部35は、外筒本体部31より小径の筒状部となっている。また、外筒本体部31の先端部(肩部)は、ノズル部35に向かってテーパー状に縮径している。
Initially, the prefilled syringe 3 is demonstrated using FIG. 1, FIG. 23 thru | or FIG.
The prefilled syringe 3 cannot be connected to a medical device having an outer cylinder main body 31 and a distal end of the outer cylinder main body 31 that is open at the distal end and has a connection portion to a nozzle portion that conforms to ISO standards. An outer cylinder 30 having a nozzle portion 35 having a specific shape, a sealing member 33 (specifically, a removable cap) for sealing the nozzle portion 35, and a slidably housed in the outer cylinder 30. The gasket 34 includes a pusher 32 attached to or attachable to the rear end of the gasket 34, and a medical liquid 38 filled in the outer cylinder 30.
The outer cylinder 30 is a cylindrical body made of a transparent or translucent material and, if necessary, a material having low oxygen permeability and water vapor permeability.
The outer cylinder 30 includes an outer cylinder main body portion 31, a nozzle portion 35 provided at the distal end portion of the outer cylinder main body portion 31, and a flange provided at the rear end portion of the outer cylinder main body portion 31.
The outer cylinder main body part 31 is a substantially cylindrical part that accommodates the gasket 34 in a liquid-tight and slidable manner, and the nozzle part 35 is a cylindrical part having a smaller diameter than the outer cylinder main body part 31. Further, the distal end portion (shoulder portion) of the outer cylinder main body portion 31 is tapered toward the nozzle portion 35 in a tapered shape.

フランジは、図1、図27に示すように、外筒本体部31の後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。フランジは、向かい合う幅広となった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。また、フランジの後端面は、周縁および外筒後端部がリブ部分以外となる部分は凹部となっている。
ノズル部35は、ISO規格に適合したノズル部への接続部を有する医療用具への接続が不能形態となっている。つまり、ノズル部35は、ISO規格(ISO594−1:1986、ISO594−2:1986)に準拠しないものとなっている。このため、このシリンジ3は、ISO規格に適合したノズル部への接続部を有する医療用具、例えば、注射針等のハブ、三方活栓のポートなどへの接続が不能である。このため、このプレフィルドシリンジ内の医療用液体の投与は極めて困難である。
この実施例のシリンジ3では、図23ないし図27に示すように、ノズル部35は、外筒本体部31の先端面より外方に突出する内筒部36と、内筒部36を被包するように設けられた外筒部37と、外筒部37の外面に設けられた係合用外側リブ39を備えている。
As shown in FIGS. 1 and 27, the flange is an elliptical donut-shaped disk portion formed so as to protrude in the vertical direction from the entire rear end circumference of the outer cylinder main body portion 31. The flange includes two gripping portions that are wide and face each other, and a plurality of ribs are formed on the tip surface side of the gripping portion. Further, the rear end surface of the flange has a concave portion at the peripheral edge and the outer cylinder rear end portion other than the rib portion.
The nozzle part 35 is in a form incapable of being connected to a medical device having a connection part to the nozzle part conforming to the ISO standard. That is, the nozzle part 35 does not conform to the ISO standard (ISO 594-1: 1986, ISO 594-2: 1986). For this reason, this syringe 3 cannot be connected to a medical device having a connection portion to a nozzle portion conforming to the ISO standard, for example, a hub such as an injection needle, a port of a three-way cock, and the like. For this reason, administration of the medical liquid in the prefilled syringe is extremely difficult.
In the syringe 3 of this embodiment, as shown in FIGS. 23 to 27, the nozzle portion 35 encloses the inner cylinder portion 36 and the inner cylinder portion 36 that protrudes outward from the distal end surface of the outer cylinder main body portion 31. The outer cylinder part 37 provided so that it may perform, and the outer rib 39 for engagement provided in the outer surface of the outer cylinder part 37 is provided.

そして、ノズル部35は、ISO規格が採用している6%テーパーを備えず、かつ外筒部37と内筒部36間が狭小に形成されることにより、6%テーパーを有するISO規格準拠の医療用雌型接続部(例えば、注射針等のハブ、三方活栓のポート)が接続不能な形態となっている。ISO規格準拠の医療用雌型接続部とは、ISO594−1:1986にある「注射筒、注射針や他の医療用具の6%(約3.43°)テーパーとの接合部の合致−パート1:一般的要求事項」を示すものである。
ISO594−1:1986に規定される規格(通常規格)の医療用雌形接続部の端部は、内径が4.270mm〜4.315mm、外径が最大6.73mmである。そして、このシリンジ3では、内筒部の先端部の外径と外筒部の先端部の内径の直径の差および外筒部の先端部の内径が、上述したものとなっているので、上記のISO594−1:1986に規定される規格の医療用雌型接続部のシリンジのノズル部35の外筒部37と内筒部36との間への侵入を防止する。
The nozzle portion 35 does not have the 6% taper adopted by the ISO standard, and is formed narrowly between the outer cylindrical portion 37 and the inner cylindrical portion 36, so that it conforms to the ISO standard having the 6% taper. A medical female connection part (for example, a hub such as an injection needle, a port of a three-way stopcock) cannot be connected. ISO standard-compliant medical female connection means “Matching part of 6% (about 3.43 °) taper of syringe barrel, needle and other medical devices in ISO594-1: 1986-Part 1: General requirements ".
The end of the medical female connector of the standard (ordinary standard) defined in ISO594-1: 1986 has an inner diameter of 4.270 mm to 4.315 mm and an outer diameter of 6.73 mm at the maximum. And in this syringe 3, since the difference of the outer diameter of the front-end | tip part of an inner cylinder part and the internal diameter of the front-end | tip part of an outer cylinder part and the inner diameter of the front-end | tip part of an outer cylinder part are what was mentioned above, Intrusion between the outer cylinder part 37 and the inner cylinder part 36 of the syringe nozzle part 35 of the medical female connection part of the standard specified in ISO594-1: 1986.

具体的には、内筒部36は、実質的にテーパーを持たない円筒状となっている。ここで実質的にテーパーを持たないとは、0〜5.5%(0〜約3.15°)程度のテーパーを有するものを含む概念である。同様に、外筒部37も実質的にテーパーを持たない円筒状となっている。ここで実質的にテーパーを持たないとは、0〜5.5%(0〜約3.15°)程度のテーパーを有するものを含む概念である。そして、ノズル部35の内筒部36の外径と外筒部37の内径との差は、0.5〜1.5mmであることが好ましく、さらには0.6〜1.0mmであることが好ましい。このようにすることにより、医療用雌型接続部の外筒部37と内筒部36との間への侵入を防止する。また、内筒部36の先端は、外筒部37の先端より若干突出していることが好ましい。突出長としては、1.5mm以下であることが好ましい。また、内筒部36の軸方向の長さとしては、6.5〜9.0mm程度が好ましい。
そして、外筒部の外面には、係合用外側リブ39が設けられている。この実施例では、螺旋状リブとなっている。具体的には、2本の螺旋状のものとなっている。
Specifically, the inner cylinder portion 36 has a cylindrical shape that does not substantially have a taper. Here, having substantially no taper is a concept including a taper of about 0 to 5.5% (0 to about 3.15 °). Similarly, the outer cylinder portion 37 has a substantially cylindrical shape with no taper. Here, having substantially no taper is a concept including a taper of about 0 to 5.5% (0 to about 3.15 °). And the difference between the outer diameter of the inner cylinder part 36 of the nozzle part 35 and the inner diameter of the outer cylinder part 37 is preferably 0.5 to 1.5 mm, and more preferably 0.6 to 1.0 mm. Is preferred. By doing in this way, the penetration | invasion between the outer cylinder part 37 of the medical female type | mold connection part and the inner cylinder part 36 is prevented. Further, it is preferable that the tip of the inner cylinder part 36 slightly protrudes from the tip of the outer cylinder part 37. The protrusion length is preferably 1.5 mm or less. Further, the axial length of the inner cylindrical portion 36 is preferably about 6.5 to 9.0 mm.
And the outer side rib 39 for engagement is provided in the outer surface of the outer cylinder part. In this embodiment, it is a spiral rib. Specifically, it has two spiral shapes.

また、外筒30のノズル部35は、封止部材33によりシールされている。この実施例では、封止部材として、取り外し可能なキャップ33が用いられている。なお、封止部材としては、ノズル部35の内筒部36の先端面を封止する剥離可能なフィルム状のものであってもよい。
外筒30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−ブタージエン−スチレン共重合体、ポリエチレンテレフター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。また、外筒30の形成材料としては、密封性を高めるために、キャップ33より相対的に硬度が高い樹脂を使用することが好ましい。このようにすると、ノズルへのキャップの取り付けの際、螺合操作に伴ってキャップがノズルに密着し、より密封性を高めることができる。
Further, the nozzle portion 35 of the outer cylinder 30 is sealed by a sealing member 33. In this embodiment, a removable cap 33 is used as the sealing member. In addition, as a sealing member, the peelable film-like thing which seals the front end surface of the inner cylinder part 36 of the nozzle part 35 may be sufficient.
Examples of the material for forming the outer cylinder 30 include polypropylene, polyethylene, polystyrene, polyamide, polycarbonate, polyvinyl chloride, poly- (4-methylpentene-1), acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyethylene terephthalate. Various resins such as polyesters such as tarates and cyclic polyolefins can be mentioned. Among them, resins such as polypropylene and cyclic polyolefins are preferable because they are easy to mold and have heat resistance. Further, as a material for forming the outer cylinder 30, it is preferable to use a resin having a relatively higher hardness than the cap 33 in order to improve the sealing performance. If it does in this way, when attaching the cap to a nozzle, a cap will stick to a nozzle with screwing operation, and it can improve sealability more.

ガスケット34は、図27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(この実施例では2つ、2つ以上であれば、液密性と摺動性を満足できれば適宜数としてもよい)を備え、これらリブが、外筒30の内面に液密に接触する。また、ガスケット34の先端面は、外筒30の先端内面に当接した時に、両者間に極力隙間を形成しないように、外筒30の先端内面形状に対応した形状となっている。
ガスケット34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、スチレンブタージエンゴムなど)、合成樹脂(例えば、SBSエラストマー、SEBS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 FIG. 27, the gasket 34 has a main body portion extending at substantially the same outer diameter, and a plurality of annular ribs provided on the main body portion (in this embodiment, two, two or more liquid-tight If the slidability is satisfied, the number may be appropriately set.) These ribs are in liquid-tight contact with the inner surface of the outer cylinder 30. Further, the front end surface of the gasket 34 has a shape corresponding to the inner surface of the front end of the outer cylinder 30 so that a gap is not formed as much as possible when contacting the inner front end of the outer cylinder 30.
As a material for forming the gasket 34, elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin) It is preferable to use an olefin-based elastomer such as a copolymer elastomer).

そして、ガスケット34には、その後端部より内部に延びる凹部が設けられ、この凹部は、雌ねじ状となっており、押子32の先端部に形成された突出部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、押子32は、ガスケット34より離脱しない。なお、押子32は、取り外しておき、使用時に取り付けるようにしてもよい。
押子32は、上述したように、先端部に筒状に突出する突出部を備え、突出部の外面には雄ねじが形成されている。また、押子32は、断面十字状の軸方向に延びる本体部と、後端部に設けられた押圧用の円盤部と、本体部の途中に設けられたリブを備えている。
プレフィルドシリンジ3内に充填される医療用液体38としては、注射用蒸留水、生理食塩水などの薬剤溶解液、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、薬剤容器内の粉末製剤の溶解が可能な薬液でもあっってもよい。
The gasket 34 is provided with a recess extending inward from the rear end thereof. The recess has a female screw shape, and is a male screw portion formed on the outer surface of the protruding portion formed at the distal end portion of the pusher 32. And can be screwed together. The pusher 32 is not detached from the gasket 34 by screwing them together. The pusher 32 may be removed and attached at the time of use.
As described above, the pusher 32 includes a protruding portion that protrudes in a cylindrical shape at the tip, and a male screw is formed on the outer surface of the protruding portion. The pusher 32 includes a main body portion extending in the axial direction having a cross-shaped cross section, a pressing disk portion provided at the rear end portion, and a rib provided in the middle of the main body portion.
The medical liquid 38 filled in the prefilled syringe 3 contains a drug solution such as distilled water for injection and physiological saline, and further contains a drug (for example, vitamins and minerals). It may be a chemical solution capable of dissolving the powder formulation.

次に、コネクター7について、図4ないし図12、図24および図27を参照して説明する。
コネクター7は、図4ないし図12、図24および図27に示すように、一端側に設けられ、ISO規格に適合したノズル部への接続部を有する医療用具に接続するための医療用具接続部72と、他端側に設けられ、プレフィルドシリンジ3のノズル部35と係合可能なシリンジ接続部とを備える。
コネクター7は、図4ないし図12に示すように、本体部71と、本体部71より突出する筒状の医療用具接続部72と、本体部に内部に設けられ、医療用具接続部72内と連通しかつその反対方向に延びる内筒部76とを備えている。医療用具接続部72は、ISO規格に適合したノズル部への接続部を有する医療用具に接続可能となっている。具体的には、医療用具接続部72は、ISO594−1に準拠した6%テーパーを有するノズル部となっており、ISO規格準拠の医療用雌型接続部(例えば、注射針等のハブ、三方活栓のポート)が接続可能となっている。
Next, the connector 7 will be described with reference to FIGS. 4 to 12, 24 and 27.
As shown in FIGS. 4 to 12, 24, and 27, the connector 7 is provided on one end side, and is connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard. 72 and a syringe connecting portion provided on the other end side and engageable with the nozzle portion 35 of the prefilled syringe 3.
As shown in FIGS. 4 to 12, the connector 7 includes a main body 71, a cylindrical medical device connection portion 72 protruding from the main body portion 71, and provided inside the main body portion. And an inner cylinder portion 76 that extends in the opposite direction. The medical device connection portion 72 can be connected to a medical device having a connection portion to a nozzle portion that conforms to the ISO standard. Specifically, the medical device connection portion 72 is a nozzle portion having a 6% taper conforming to ISO594-1, and is a medical female connection portion conforming to the ISO standard (for example, a hub such as an injection needle, three-way A stopcock port) can be connected.

そして、本体部71内にシリンジ接続部が形成されている。内筒部76は、図20ないし図27、特に、図24に示すように、シリンジ3のノズル部35の内筒部36を収納可能となっており、収納状態にて両者は液密状態となっている。
本体部71は、図4ないし図12に示すように、内筒部76を被包する筒状外筒部であり、端部にフランジ73を備えている。また、本体部71と内筒部76間に、シリンジのノズル部35の外筒部37を収納可能となっている。本体部71の基端部(フランジ側部分)の内面には、シリンジ3のノズル部35の外筒本体部31の外面に設けられた係合用外側リブ39と係合する係合用内側リブ75を備えている。この実施例のものでは、係合用内側リブ75は、係合用外側リブ39の螺旋形態に対応した短い螺旋状のものとなっている。また、係合用内側リブ75は、図10に示すように、向かい合うように2つ設けられている。本体部71は、側面に設けられ、本体部71の先端(ノズル側)から所定長基端側(フランジ側)に延びる窓部77を備えている。この実施例のものでは、窓部77は、向かい合うように2つ設けられており、内筒部76を外部より視認可能となっている。また、本体部には、側面に設けられた平坦部74とその端部(フランジ側)に設けられたリブ78と、平坦部74の両側部に設けられたスリット79からなる後述する穿刺部材6のコネクター装着部61への装着部を備えている。このため、この実施例の薬剤投与具1では、コネクター7と穿刺部材6は、穿刺部材6のコネクター装着部に装着されたコネクター7が穿刺部材6に対して回転することを規制する。そして、上記の装着部を備えることにより、穿刺部材6のコネクター装着部61に装着されたコネクターの回転を規制しかつ不用意な離脱を防止する。なお、この実施例では、コネクターは、平坦部74、平坦部74の端部(フランジ側)に設けられたリブ78、平坦部74の両側部に設けられたスリット79のそれぞれは、向かい合うように2つ設けられている。
A syringe connection portion is formed in the main body portion 71. The inner cylinder part 76 can accommodate the inner cylinder part 36 of the nozzle part 35 of the syringe 3, as shown in FIGS. It has become.
As shown in FIGS. 4 to 12, the main body 71 is a cylindrical outer cylinder that encloses the inner cylinder 76, and includes a flange 73 at the end. Further, the outer cylinder part 37 of the nozzle part 35 of the syringe can be accommodated between the main body part 71 and the inner cylinder part 76. On the inner surface of the base end portion (flange side portion) of the main body portion 71, an engagement inner rib 75 that engages with the engagement outer rib 39 provided on the outer surface of the outer cylinder main body portion 31 of the nozzle portion 35 of the syringe 3. I have. In this embodiment, the engagement inner rib 75 has a short spiral shape corresponding to the spiral form of the engagement outer rib 39. Further, as shown in FIG. 10, two engagement inner ribs 75 are provided so as to face each other. The main body portion 71 includes a window portion 77 provided on a side surface and extending from the distal end (nozzle side) of the main body portion 71 to a predetermined long base end side (flange side). In this embodiment, two window parts 77 are provided so as to face each other, and the inner cylinder part 76 is visible from the outside. Further, the main body portion includes a flat portion 74 provided on the side surface, a rib 78 provided on the end portion (flange side), and slits 79 provided on both sides of the flat portion 74, which will be described later. The connector mounting portion 61 is provided with a mounting portion. For this reason, in the drug administration device 1 of this embodiment, the connector 7 and the puncture member 6 restrict the rotation of the connector 7 attached to the connector attachment portion of the puncture member 6 with respect to the puncture member 6. And by providing said mounting part, rotation of the connector with which the connector mounting part 61 of the puncture member 6 was mounted | worn is controlled and careless detachment | leave is prevented. In this embodiment, the connector is such that the flat portion 74, the rib 78 provided on the end portion (flange side) of the flat portion 74, and the slit 79 provided on both sides of the flat portion 74 face each other. Two are provided.

次に、穿刺部材6について、図4ないし図7、図13ないし図17、図24および図27を参照して説明する。
穿刺部材6は、一端に薬剤容器4のシール部材42を貫通可能な刃先部を有する中空針状部62と、他端側に設けられ、コネクター7を着脱可能に接続するコネクター装着部61と、中空針状部62の中央部より他端側を被包する筒状のカラー部63とを備えている。
コネクター装着部61は、短い筒状部であり、その一端より、中空針状部62が所定長延びるものとなっており、他端部にフランジ64を備えている。ま。また、中空針状部62は、コネクター装着部61より、外径、内径ともに小さいものとなっている。
コネクター装着部61は、内部にコネクター7のフランジ部付近を除く部分を着脱可能に収納する。なお、コネクター7を穿刺部材6に装着すると、医療用具接続部(ノズル部)72は、図4ないし図7に示すように、中空状針状部62の基端部内に侵入するものとなっている。また、コネクター装着部61内には、コネクター7の穿刺部材6への装着時に、両者間により狭圧されるシール部材99が配置されている。このため、コネクター7は穿刺部材6に液密に装着されている。なお、コネクター7と穿刺部材6間の液密状態の形成は、図4に示すように、中空状針状部62の基端部の内面と、基端部内に侵入した医療用具接続部(ノズル部)72の外面間の接触により形成してもよい。また、コネクター装着部61は、図14に示すように、側面内側に設けられた平坦部95を備えている。また、この実施例では、平坦部95は、向かい合うように2つ設けられている。また、平坦部95は、内面のみならず外面も平坦なものとなっている。さらに、平坦部95の端部(フランジ側)には、スロット(開口部)69が設けられている。このスロット69は、コネクターの平坦部74の端部に設けられたリブ78と係合するものとなっている。この実施例では、スロット69も向かい合うように2つ設けられている。
さらに、穿刺部材6は、コネクター装着部61の中空針状部側に設けられたスロット(開口部)67を備えている。また、この実施例では、スロット67は、向かい合うように2つ設けられている。そして、スロット67の基端側(フランジ側)にリブ98を備えている。リブ98は、コネクター7を穿刺部材6に装着する際、窓部77内に侵入し、窓部77の側壁と係合するものとなっている。この実施例では、リブ98は、スロット67側が高く、基端側(フランジ側)に向かって低くなる傾斜リブとなっている。また、リブ98は、向かい合うように2つ設けられている。
Next, the puncture member 6 will be described with reference to FIGS. 4 to 7, 13 to 17, 24 and 27.
The puncture member 6 has a hollow needle-like portion 62 having a cutting edge portion that can penetrate the seal member 42 of the drug container 4 at one end, a connector mounting portion 61 that is provided on the other end side and removably connects the connector 7; And a cylindrical collar portion 63 that encloses the other end side of the center portion of the hollow needle-like portion 62.
The connector mounting portion 61 is a short cylindrical portion, and a hollow needle-like portion 62 extends a predetermined length from one end thereof, and a flange 64 is provided at the other end portion. Well. Further, the hollow needle-like portion 62 has a smaller outer diameter and inner diameter than the connector mounting portion 61.
The connector mounting portion 61 detachably accommodates a portion excluding the vicinity of the flange portion of the connector 7 inside. When the connector 7 is attached to the puncture member 6, the medical device connection part (nozzle part) 72 enters the proximal end part of the hollow needle-like part 62 as shown in FIGS. 4 to 7. Yes. In addition, a seal member 99 is disposed in the connector mounting portion 61 so as to be narrowed between the two when the connector 7 is mounted on the puncture member 6. For this reason, the connector 7 is liquid-tightly attached to the puncture member 6. As shown in FIG. 4, the liquid-tight state between the connector 7 and the puncture member 6 is formed by the inner surface of the proximal end portion of the hollow needle-like portion 62 and the medical device connecting portion (nozzle that has entered the proximal end portion). Part) 72 may be formed by contact between the outer surfaces. Moreover, the connector mounting part 61 is provided with the flat part 95 provided in the side surface inner side, as shown in FIG. In this embodiment, two flat portions 95 are provided so as to face each other. Further, the flat portion 95 has a flat outer surface as well as an inner surface. Furthermore, a slot (opening) 69 is provided at the end (flange side) of the flat portion 95. The slot 69 is engaged with a rib 78 provided at the end of the flat portion 74 of the connector. In this embodiment, two slots 69 are also provided so as to face each other.
Furthermore, the puncture member 6 includes a slot (opening) 67 provided on the hollow needle-like part side of the connector mounting part 61. In this embodiment, two slots 67 are provided so as to face each other. A rib 98 is provided on the base end side (flange side) of the slot 67. The rib 98 penetrates into the window 77 when the connector 7 is attached to the puncture member 6, and engages with the side wall of the window 77. In this embodiment, the ribs 98 are inclined ribs that are higher on the slot 67 side and lower toward the base end side (flange side). Two ribs 98 are provided so as to face each other.

カラー部63は、中空針状部62の中央部より他端側を被包する筒状体である。具体的には、カラー部63は、コネクター装着部61の端部より、中空針状部62と平行にかつ中空針状部62の刃先方向に延びており、中空針状部62の中央部を若干越えた位置にて終端している。そして、この実施例のものでは、穿刺部材6は、カラー部63の先端部の内面に設けられた突出部96を備えている。また、この実施例では、突出部96は、向かい合うように2つ設けられている。さらに、カラー部63は、上述した突出部よりコネクター装着部61方向に所定長、具体的には、ほぼコネクター装着部61まで)伸びる、窓部65を備えている。また、この実施例では、窓部65は、向かい合うように2つ設けられている。
この実施例では、中空状針状部62は、図4、図13ないし図17に示すように、先端側より、鋭角の刃先部を形成するテーパー角を有する第1領域と、この第1領域と連続し、なだらかなテーパー角もしくは実質的にテーパー角を持たない第2領域と、この第2領域と連続し、第2領域のテーパー角より所定角大きいテーパー角を有する第3領域と、この第3領域と連続し、なだらかなテーパー角もしくは実質的にテーパー角を持たない第4領域を有するものとなっていることが好ましい。
第1領域のテーパー角(テーパー拡がり角)としては、90°以下が好ましく、長さは、2.0〜5.0mmが好ましい。第2の領域のテーパー角(テーパー拡がり角)としては、0°〜10°が好ましく、長さは、5.0〜20.0mmが好ましい。第3領域のテーパー角(テーパー拡がり角)としては、20°〜90°が好ましく、長さは、2.0〜5.0mmが好ましく、第3領域の開始端は、中空針状部の先端より10〜25mm基端側であることが好ましい。また、第4領域のテーパー角(テーパー拡がり角)としては、0°〜10°が好ましく、長さは、10〜20mmが好ましい。
そして、中空針状部の先端部、具体的には、刃先部の側面に側孔62aが設けられており、中空針状部内と外部とを接続している。
The collar part 63 is a cylindrical body that encloses the other end side from the center part of the hollow needle-like part 62. Specifically, the collar portion 63 extends from the end portion of the connector mounting portion 61 in parallel with the hollow needle-like portion 62 and toward the blade edge of the hollow needle-like portion 62, and the central portion of the hollow needle-like portion 62 is It ends at a position slightly beyond. In this embodiment, the puncture member 6 includes a protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63. In this embodiment, two protrusions 96 are provided so as to face each other. Further, the collar portion 63 includes a window portion 65 that extends from the protruding portion in the direction of the connector mounting portion 61 by a predetermined length (specifically, substantially up to the connector mounting portion 61). In this embodiment, two window portions 65 are provided so as to face each other.
In this embodiment, as shown in FIGS. 4 and 13 to 17, the hollow needle-like portion 62 includes a first region having a taper angle that forms an acute blade edge portion from the tip side, and the first region. A second region that has a smooth taper angle or substantially no taper angle, a third region that is continuous with the second region and has a taper angle larger than the taper angle of the second region by a predetermined angle, It is preferable to have a fourth region that is continuous with the third region and has no gentle taper angle or substantially no taper angle.
The taper angle (taper expansion angle) of the first region is preferably 90 ° or less, and the length is preferably 2.0 to 5.0 mm. The taper angle (taper spread angle) of the second region is preferably 0 ° to 10 °, and the length is preferably 5.0 to 20.0 mm. The taper angle (taper spread angle) of the third region is preferably 20 ° to 90 °, the length is preferably 2.0 to 5.0 mm, and the starting end of the third region is the tip of the hollow needle-like portion. It is more preferably 10 to 25 mm on the base end side. The taper angle (taper divergence angle) of the fourth region is preferably 0 ° to 10 °, and the length is preferably 10 to 20 mm.
And the side hole 62a is provided in the front-end | tip part of a hollow needle-like part, specifically, the side surface of a blade edge | tip part, and the inside of a hollow needle-like part and the exterior are connected.

次に、ガイド部材5について、図1ないし図7、図18ないし図20、図24ないし図26を参照して説明する。
ガイド部材5は、シール部材42にてシールされた開口部に接続可能な薬剤容器装着部51と、装着部51より延び、かつ、穿刺部材6の中空針状部62が内側にかつカラー部63が外側を移動可能な中空針状部収納用筒状部54とを有する。
薬剤容器装着部51は、比較的大径の短い筒状部となっており、内部に、シール部材42にてシールされた薬剤容器の開口部を収納可能となってる。また、薬剤容器装着部51の側部には、内方に突出し、薬剤容器の開口部の下部(薬剤容器の首部の下部)と係合する爪部58を備えている。また、薬剤容器装着部51の爪部58の上部側(中空針状部収納用筒状部側)は、窓部89となっている。そして、この実施例では、装着部51に易変形性を付与するためのスリット81が設けられている。この実施例では、スリット81は、上記の爪部および窓部の両サイドに装着部の下端より上部側(中空針状部収納用筒状部側)に延びるものとなっている。そして、この実施例では、爪部58、窓部89,スリット81は、向かい合うように2組設けられている。具体的には、スリット81は、図20に示すように4本設けられており、スリット81は、薬剤容器装着部51の上面に到達し、さらに、向かい合うスリット方向に所定長延びるものとなっている。この実施例では、スリット81は、薬剤容器装着部51の側部には、箱状のサイド部55、56が設けられており、ガイド部材51の薬剤容器4への装着時の操作部として機能する。
Next, the guide member 5 will be described with reference to FIGS. 1 to 7, 18 to 20, and FIGS. 24 to 26.
The guide member 5 has a medicine container mounting portion 51 that can be connected to the opening sealed by the seal member 42, and extends from the mounting portion 51, and the hollow needle-shaped portion 62 of the puncture member 6 is located on the inner side and the collar portion 63. Has a hollow needle-like portion storage tubular portion 54 that can move outside.
The medicine container mounting portion 51 is a short cylindrical portion having a relatively large diameter, and can accommodate the opening portion of the medicine container sealed by the seal member 42 therein. Further, the side part of the medicine container mounting part 51 is provided with a claw part 58 that protrudes inward and engages with the lower part of the opening part of the medicine container (the lower part of the neck part of the medicine container). The upper side of the claw portion 58 of the drug container mounting portion 51 (the hollow needle-like portion storage tubular portion side) is a window portion 89. In this embodiment, a slit 81 for imparting easy deformability to the mounting portion 51 is provided. In this embodiment, the slit 81 extends from the lower end of the mounting portion to the upper side (the hollow needle-like portion storing tubular portion side) on both sides of the claw portion and the window portion. In this embodiment, two sets of the claw portion 58, the window portion 89, and the slit 81 are provided so as to face each other. Specifically, four slits 81 are provided as shown in FIG. 20, and the slit 81 reaches the upper surface of the drug container mounting portion 51 and further extends a predetermined length in the facing slit direction. Yes. In this embodiment, the slit 81 is provided with box-shaped side portions 55 and 56 on the side of the medicine container mounting portion 51, and functions as an operation portion when the guide member 51 is attached to the medicine container 4. To do.

中空針状部収納用筒状部54は、薬剤容器装着部51の上面の中心部より突出する同一外径の筒状部である。この実施例では、ガイド部材5は、中空針状部収納用筒状部54の開口端側の外面に設けられ、中空針状部収納用筒状部54の軸方向かつ薬剤容器装着部51側より中空状針状部収納用筒状部54の端部(自由端)方向に延び、かつ穿刺部材6のカラー部63の突出部96を摺動可能に収納する軸方向溝部86を備えている。そして、この実施例では、さらに、軸方向溝部86内かつ装着部51側に位置し、穿刺部材6の突出部96と係合可能な係合リブ87を備えている。この実施例では、穿刺部材6のガイド部材5からの離脱を抑制する係合部は、穿刺部材6の突出部96とガイド部材5の軸方向溝部86内の係合リブ87とにより構成されている。係合リブ87は、溝部の底面に対して突出するリブ状部分である。穿刺部材6の突出部96は、中空針状部収納用筒状部54の軸方向溝部86を摺動しながら移動し、係合リブ87を乗り越え、軸方向溝端部86aに侵入することにより、係合し、穿刺部材6の離脱(後退)を防止する。
さらに、この実施例では、ガイド部材5は、中空針状部収納用筒状部54の開口端側の外面に設けられ、筒状部54の周方向に延びかつ穿刺部材6の突出部96を摺動可能に収納する周方向溝部85を備えている。この周方向溝部85は、上述した軸方向溝部86の端部とつながっている。さらに、この実施例では、ガイド部材5は、中空針状部収納用筒状部54の外面に設けられた周方向溝部と連続し、中空針状部収納用筒状部54の自由端まで延びかつ穿刺部材6の突出部96を摺動可能に収納する誘導用軸方向溝部88を備えている。このため、中空針状部収納用筒状部54の、中空針状部収納用筒状部54の周方向溝部85への穿刺部材6の突出部96の誘導が容易となる。そして、この実施例では、軸方向溝部86、係合リブ87、周方向溝部85、誘導用軸方向溝部88は、それぞれ向かい合う位置に2つ設けられている。
The hollow needle-shaped portion storage tubular portion 54 is a tubular portion having the same outer diameter that protrudes from the central portion of the upper surface of the drug container mounting portion 51. In this embodiment, the guide member 5 is provided on the outer surface on the opening end side of the hollow needle-like portion storage tubular portion 54, and is axial in the hollow needle-like portion storage tubular portion 54 and on the drug container mounting portion 51 side. Further, an axial groove 86 is provided that extends in the end (free end) direction of the hollow needle-like-accommodating tubular portion 54 and slidably accommodates the protruding portion 96 of the collar portion 63 of the puncture member 6. . In this embodiment, an engaging rib 87 is provided which is located in the axial groove 86 and on the mounting portion 51 side and can be engaged with the protruding portion 96 of the puncture member 6. In this embodiment, the engaging portion that prevents the puncture member 6 from being detached from the guide member 5 is constituted by the protruding portion 96 of the puncture member 6 and the engagement rib 87 in the axial groove portion 86 of the guide member 5. Yes. The engagement rib 87 is a rib-like portion that protrudes from the bottom surface of the groove portion. The projecting portion 96 of the puncture member 6 moves while sliding on the axial groove 86 of the hollow needle-like storage cylindrical portion 54, gets over the engagement rib 87, and enters the axial groove end portion 86a. Engage and prevent puncture member 6 from being detached (retracted).
Further, in this embodiment, the guide member 5 is provided on the outer surface on the opening end side of the hollow needle-like portion storage tubular portion 54, extends in the circumferential direction of the tubular portion 54, and has the protruding portion 96 of the puncture member 6. A circumferential groove 85 is slidably accommodated. The circumferential groove 85 is connected to the end of the axial groove 86 described above. Further, in this embodiment, the guide member 5 is continuous with the circumferential groove portion provided on the outer surface of the hollow needle-like portion storage tubular portion 54 and extends to the free end of the hollow needle-like portion storage tubular portion 54. In addition, a guide axial groove 88 is provided for slidably storing the protruding portion 96 of the puncture member 6. For this reason, it becomes easy to guide the protruding portion 96 of the puncture member 6 to the circumferential groove portion 85 of the hollow needle-like portion storage tubular portion 54 of the hollow needle-like portion storage tubular portion 54. In this embodiment, two axial groove portions 86, engaging ribs 87, circumferential groove portions 85, and guiding axial groove portions 88 are provided at positions facing each other.

本発明の薬剤投与具1は、コネクター7にシリンジ3を接続し、シリンジ3を押し込むことにより、穿刺部材6はガイド部材5内を進行し、薬剤容器4のシール部材42を刺通する。そして、穿刺部材6とガイド部材5は、穿刺部材6による薬剤容器4のシール部材42への刺通完了後に係合し、穿刺部材6のガイド部材5からの離脱を抑制する係合部を備えている。
この実施例の薬剤投与具1では、穿刺部材6は、上述したように、カラー部63の先端部の内面に設けられた突出部96を備え、ガイド部材5は、中空針状部収納用筒状部54の外面に設けられ、開口端側より装着部51方向に延びかつ穿刺部材6の突出部96を摺動可能に収納する軸方向溝部86と、軸方向溝部86内かつ装着部51側に位置し、穿刺部材6の突出部96と係合可能な係合リブ87を備えている。上記の穿刺部材のガイド部材からの離脱を抑制する係合部は、穿刺部材6の突出部96とガイド部材5の軸方向溝部86内の係合リブ87とにより構成されている。
また、この実施例では、ガイド部材5は、中空状針状部収納用筒状部54の外方に位置し、中空状針状部収納用筒状部54の端部方向(自由端方向)に延びる外側ガイド部52を備えている。そして、穿刺部材6のカラー部63は、外側ガイド部52と中空針状部収納用筒状部54間を移動する。ガイド部材5の外側ガイド部52と穿刺部材6は、穿刺部材6が薬剤容器4のシール部材42への刺通完了後に係合し、穿刺部材6のガイド部材5からの離脱を抑制する係合部(離脱抑制係合部)を備えている。
In the drug administration device 1 of the present invention, the syringe 3 is connected to the connector 7 and the syringe 3 is pushed in, whereby the puncture member 6 advances in the guide member 5 and pierces the seal member 42 of the drug container 4. The puncture member 6 and the guide member 5 are engaged with each other after the puncture member 6 completes the piercing of the drug container 4 to the seal member 42 and suppresses the puncture member 6 from being detached from the guide member 5. ing.
In the drug administration device 1 of this embodiment, the puncture member 6 includes the protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63 as described above, and the guide member 5 is a hollow needle-like portion storage cylinder. An axial groove 86 provided on the outer surface of the shaped portion 54, extending in the direction of the mounting portion 51 from the opening end side, and slidably storing the protruding portion 96 of the puncture member 6, and within the axial groove 86 and on the mounting portion 51 side And an engaging rib 87 that is engageable with the protruding portion 96 of the puncture member 6. The engaging portion that suppresses the puncture member from being detached from the guide member is constituted by a protruding portion 96 of the puncture member 6 and an engagement rib 87 in the axial groove portion 86 of the guide member 5.
Further, in this embodiment, the guide member 5 is located outside the hollow needle-like portion storage tubular portion 54 and is in the end direction (free end direction) of the hollow needle-like portion storage tubular portion 54. The outer guide part 52 is provided. The collar portion 63 of the puncture member 6 moves between the outer guide portion 52 and the hollow needle-like portion storage tubular portion 54. The outer guide portion 52 of the guide member 5 and the puncture member 6 are engaged after the puncture member 6 is completed after the drug container 4 has been pierced into the seal member 42 and the puncture member 6 is prevented from being detached from the guide member 5. Part (separation inhibiting engagement part).

具体的には、この実施例では、ガイド部材5は、弾性変形可能な薄板状部材により形成された外側ガイド部52と、この外側ガイド部52の向かい合うように設けられた第2の外側ガイド部53を備えている。そして、穿刺部材6のカラー部63は、外側ガイド部52および外側ガイド部53の内側かつ中空針状部収納用筒状部54の外側を移動する。そして、外側ガイド部52の自由端側の内面(自由端より若干装着部側の内面)に係合用リブ52aが設けられている。同様に、外側ガイド部53の自由端側の内面(自由端より若干装着部側の内面)にも係合用リブ53aが設けられている。そして、図24に示すように、この係合用リブ52a、53aは、穿刺部材5の平坦部74の端部(フランジ側)に設けられたスロット(開口部)69と係合可能となっている。よって、この実施例の薬剤投与具では、穿刺部材のガイド部材からの離脱を抑制する係合部は、外側ガイド部52,53の係合用リブ52a、53aと、穿刺部材5のスロット(開口部)69とにより構成されている。上述したように、この実施例の薬剤投与具では、穿刺部材のガイド部材からの離脱を抑制する係合部として、2組の構成を有している。このように2組の係合手段を備えることが好ましいが、いずれか一方のみであってもよい。また、穿刺部材6側の係合部は、上述したスロット(開口部)に限定されるものではなく、穿刺部材6の外面に形成された凹部であってもよい。また、外側ガイド部52および外側ガイド部53の自由端側部分52b、53bは、図3に示すように平板状に大きく広がる拡幅部となっている。 Specifically, in this embodiment, the guide member 5 includes an outer guide portion 52 formed of an elastically deformable thin plate member, and a second outer guide portion provided so as to face the outer guide portion 52. 53. The collar portion 63 of the puncture member 6 moves inside the outer guide portion 52 and the outer guide portion 53 and outside the hollow needle-like portion storage tubular portion 54. An engagement rib 52a is provided on the inner surface on the free end side of the outer guide portion 52 (the inner surface on the mounting portion side slightly from the free end). Similarly, an engagement rib 53a is also provided on the inner surface on the free end side of the outer guide portion 53 (the inner surface on the mounting portion side slightly from the free end). 24, the engaging ribs 52a and 53a are engageable with a slot (opening) 69 provided at the end (flange side) of the flat portion 74 of the puncture member 5. . Therefore, in the drug administration device of this embodiment, the engaging portions that suppress the separation of the puncture member from the guide member are the engagement ribs 52a and 53a of the outer guide portions 52 and 53 and the slot (opening portion) of the puncture member 5. 69). As described above, the drug administration device of this embodiment has two sets of configurations as the engaging portion that suppresses the puncture member from being detached from the guide member. Thus, although it is preferable to provide two sets of engaging means, only one of them may be provided. Further, the engaging portion on the puncture member 6 side is not limited to the above-described slot (opening), and may be a recess formed on the outer surface of the puncture member 6. Moreover, the free end side parts 52b and 53b of the outer side guide part 52 and the outer side guide part 53 are the widened part which spreads widely in flat form as shown in FIG.

そして、この実施例の薬剤投与具1では、上述したように、穿刺部材6は、カラー部63の先端部の内面に設けられた突出部96を備え、ガイド部材5は、中空針状部収納用筒状部54の外面に設けられた周方向溝部85と、周方向溝部85と連続する軸方向溝部86とを備えるとともに、穿刺部材6の突出部96が、ガイド部材5の周方向溝部88内に位置し、穿刺部材6のカラー部63に対する周方向への移動を許容し、かつ、軸方向への移動が規制された状態となっている。このため、この状態では、穿刺部材6は、薬剤容器4のシール部材42を穿刺する方向には移動しないものとなってる。
そして、この実施例の薬剤投与具1では、穿刺部材6は、穿刺部材6をガイド部材5の中空針状部収納用筒状部54の周方向に回転させることにより、穿刺部材6の突出部96が中空針状部収納用筒状部54の軸方向溝部86内に移動し、穿刺部材6のガイド部材5の装着部51方向への移動が可能となるものとなっている。さらに、穿刺部材6の突出部をガイド部材の周方向溝部から軸方向溝部へ移行させるための回転方向は、シリンジ3の外筒31のノズル部35の係合用外側リブ39をコネクター7の外側筒状部71の係合用内側リブ75とを係合させるための回転方向と同じものとなっている。このため、シリンジ3のコネクター7への装着作業であるシリンジの回転操作を行うことにより、継続的(自動的)に、穿刺部材6の突出部が、ガイド部材の周方向溝部から軸方向溝部に移行する。
In the drug administration device 1 of this embodiment, as described above, the puncture member 6 includes the protruding portion 96 provided on the inner surface of the distal end portion of the collar portion 63, and the guide member 5 is accommodated in the hollow needle-like portion. A circumferential groove 85 provided on the outer surface of the tubular portion 54 and an axial groove 86 continuous with the circumferential groove 85, and the protrusion 96 of the puncture member 6 is a circumferential groove 88 of the guide member 5. The puncture member 6 is allowed to move in the circumferential direction with respect to the collar portion 63, and the movement in the axial direction is restricted. For this reason, in this state, the puncture member 6 does not move in the direction of puncturing the seal member 42 of the drug container 4.
In the drug administration device 1 of this embodiment, the puncture member 6 rotates the puncture member 6 in the circumferential direction of the hollow needle-like portion storage tubular portion 54 of the guide member 5, thereby causing the protruding portion of the puncture member 6 to move. 96 moves into the axial groove 86 of the hollow needle-like storage cylindrical portion 54 so that the puncture member 6 can be moved in the direction of the mounting portion 51 of the guide member 5. Further, the rotation direction for moving the protruding portion of the puncture member 6 from the circumferential groove portion of the guide member to the axial groove portion is such that the engaging outer rib 39 of the nozzle portion 35 of the outer tube 31 of the syringe 3 is connected to the outer tube of the connector 7. This is the same as the rotation direction for engaging the engaging inner rib 75 of the shaped portion 71. For this reason, by performing a rotation operation of the syringe, which is an operation of attaching the syringe 3 to the connector 7, the protruding portion of the puncture member 6 is continuously (automatically) changed from the circumferential groove portion of the guide member to the axial groove portion. Transition.

薬剤容器4は、開口部を有する容器本体41と、容器本体41の開口部を封止するシール部材42と、容器本体41内に収納された薬剤43とからなる。
容器本体41としては、開口部を有し、内部に薬剤43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、ガラス容器などが使用される。開口部をシールするシール部材としては、穿刺部材6の中空針状部62による穿刺(刺通)が可能なものであればどのようなものでもよい。シール部材としては、例えば、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、スチレンブタージエンゴムなど)、合成樹脂(例えば、SBSエラストマー、SEBS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。
薬剤としては、プレフィルドシリンジ内に充填される医療用液体(具体的には、溶解液)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、ビターミン剤(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、不整脈用剤等が挙げられる。
The medicine container 4 includes a container body 41 having an opening, a seal member 42 that seals the opening of the container body 41, and a medicine 43 accommodated in the container body 41.
The container main body 41 may be anything as long as it has an opening and can store the medicine 43 therein. For example, a rigid or semi-rigid synthetic resin container, a glass container, or the like is used. The sealing member that seals the opening may be any member that can puncture (pierce) with the hollow needle-like portion 62 of the puncture member 6. Examples of the sealing member include elastic rubber (for example, butyl rubber, latex rubber, silicone rubber, styrene butadiene rubber), synthetic resin (for example, styrene elastomer such as SBS elastomer and SEBS elastomer, ethylene-α olefin copolymer). It is preferable to use an olefin elastomer such as a polymer elastomer).
Any drug, such as a powdered drug, a lyophilized drug, a solid drug, or a liquid drug, can be used as long as it can be dissolved in a medical liquid (specifically, a solution) filled in the prefilled syringe. It may be. Examples of drugs include vitamins (multivitamins), various amino acids, antithrombotic agents such as heparin, insulin, antibiotics, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, antiparkinson agents, and ulcer treatments Agents, corticosteroids, arrhythmic agents and the like.

次に、本発明の薬剤投与具および薬剤容器装着済み薬剤投与具の作用を図1、図21ないし図27を用いて説明する。
この例では、薬剤容器装着済み薬剤投与具1が用いられている。
薬剤容器装着済み薬剤投与具1は、図1に示すように、薬剤容器4にアダプター2が装着され、プレフィルドシリンジ3は、ノズル部にキャップ33が装着された状態にて、セットで提供される。
そして、図21に示すように、プレフィルドシリンジ3のキャップ33を取り外した後、シリンジ3のノズル部をアダプター2のコネクター7の後端部内に挿入する。そして、シリンジ3のノズル部をアダプター2のコネクター7の後端部内に挿入後、回転させることにより、シリンジ3のノズル部35の外筒本体部31の外面に設けられた係合用外側リブ39とコネクター7の本体部71の端部内面に設けられた係合用内側リブ75とが係合し、プレフィルドシリンジ3がアダプター2に装着されるとともに、シリンジの先端部にコネクターが装着された状態となる。そして、シリンジの上記の装着のための回転操作を継続することにより、シリンジ3とともにシリンジに装着されたコネクター7およびコネクター7が装着されている穿刺部材6が若干回転(約90度)する。これにより、穿刺部材6のカラー部63の突出部96が、ガイド部材5の中空針状部収納用筒状部54の周方向溝部85から軸方向溝部85に移行する。図22はその状態の外観図でり、図23は、その状態の断面図である。そして、シリンジ3を薬剤容器4方向に押すことにより、図24に示すように、シリンジ3,コネクター7および穿刺部材6は、薬剤容器4方向に進行し、穿刺部材6の中空針状部62は、薬剤容器4のシール部材42を刺通し、その先端部が、薬剤容器内に到達する。そして、シリンジ3のプランジャーを押圧することにより、シリンジ3内の医療用液体(溶解液)が、薬剤容器内に流入する。図25にその状態が図示されている。そして、適宜、混和操作を行った後、図26に示すように、薬剤容器4を上方にして、シリンジ3のプランジャー32を引くことにより、薬剤容器内の薬剤溶解済み液体45は、シリンジ内に回収される。穿刺部材6による薬剤容器4のシール部材42への刺通完了後には、穿刺部材6の突出部96とガイド部材5の軸方向溝部86内の係合リブ87が係合しているため、穿刺部材6のガイド部材5からの離脱が抑制されているので、上記の医療用液体の薬剤容器への注入およびシリンジへの回収作業が容易である。そして、アダプター2のコネクター4はシリンジ3のノズル部に係合しているため、アダプター2よりシリンジ3を引くと、図27に示すように、シリンジ3のノズル部35にコネクター7が装着した状態となるため、コネクター7のノズル部72を用いることにより、一般的な投与手段である注射針ハブ、三方活栓のポートへの接続が可能となり、シリンジ内に回収された薬剤溶解済み医療用液体を直接投与、間接投与など任意の投与形態による投与が可能となる。
Next, the operation of the drug administration device of the present invention and the drug administration device loaded with a drug container will be described with reference to FIGS.
In this example, a drug administration device 1 with a drug container mounted thereon is used.
As shown in FIG. 1, the drug administration device 1 with the drug container mounted is provided as a set with the adapter 2 mounted on the drug container 4 and the prefilled syringe 3 mounted with the cap 33 on the nozzle portion. .
Then, as shown in FIG. 21, after removing the cap 33 of the prefilled syringe 3, the nozzle portion of the syringe 3 is inserted into the rear end portion of the connector 7 of the adapter 2. Then, by inserting the nozzle portion of the syringe 3 into the rear end portion of the connector 7 of the adapter 2 and rotating it, the outer rib 39 for engagement provided on the outer surface of the outer cylinder main body portion 31 of the nozzle portion 35 of the syringe 3 and The inner rib 75 for engagement provided on the inner surface of the end of the main body 71 of the connector 7 is engaged, and the prefilled syringe 3 is attached to the adapter 2 and the connector is attached to the tip of the syringe. . Then, by continuing the above rotation operation for mounting the syringe, the connector 7 mounted on the syringe together with the syringe 3 and the puncture member 6 mounted with the connector 7 are slightly rotated (about 90 degrees). Thereby, the protruding portion 96 of the collar portion 63 of the puncture member 6 shifts from the circumferential groove portion 85 of the hollow needle-like portion storage tubular portion 54 of the guide member 5 to the axial groove portion 85. FIG. 22 is an external view of the state, and FIG. 23 is a cross-sectional view of the state. Then, by pushing the syringe 3 in the direction of the drug container 4, as shown in FIG. 24, the syringe 3, the connector 7 and the puncture member 6 advance in the direction of the drug container 4, and the hollow needle-like portion 62 of the puncture member 6 is Then, the seal member 42 of the drug container 4 is pierced, and the tip portion reaches the drug container. Then, by pressing the plunger of the syringe 3, the medical liquid (dissolved solution) in the syringe 3 flows into the drug container. FIG. 25 shows the state. Then, after appropriately performing the mixing operation, as shown in FIG. 26, the drug-dissolved liquid 45 in the drug container is placed in the syringe by pulling the plunger 32 of the syringe 3 with the drug container 4 facing upward. To be recovered. After the puncture member 6 completes the puncture of the drug container 4 to the seal member 42, the protrusion 96 of the puncture member 6 and the engagement rib 87 in the axial groove 86 of the guide member 5 are engaged. Since the detachment of the member 6 from the guide member 5 is suppressed, it is easy to inject the medical liquid into the medicine container and collect it into the syringe. Since the connector 4 of the adapter 2 is engaged with the nozzle portion of the syringe 3, when the syringe 3 is pulled from the adapter 2, the connector 7 is attached to the nozzle portion 35 of the syringe 3 as shown in FIG. Therefore, by using the nozzle portion 72 of the connector 7, it is possible to connect to a syringe hub or a three-way stopcock port which is a general administration means, and the medicine-dissolved medical liquid collected in the syringe can be used. Administration by any administration form such as direct administration and indirect administration is possible.

1 薬剤容器装着済み薬剤投与具
2 アダプター
3 プレフィルドシリンジ
4 薬剤容器
5 ガイド部材
6 穿刺部材
7 コネクター
DESCRIPTION OF SYMBOLS 1 Drug administration device with medicine container mounted 2 Adapter 3 Prefilled syringe 4 Drug container 5 Guide member 6 Puncture member
7 Connector

Claims (16)

外筒本体部と、該外筒本体部の先端部に設けられ先端が開口し、かつ、ISO規格に適合したノズル部への接続部を有する医療用具の前記接続部への接続が不能な形態を有するノズル部を備える外筒と、前記ノズル部を封止する封止部材と、前記外筒内に摺動可能に収納されたガスケットと、該ガスケットの後端に取り付けられたもしくは取付可能な押子と、前記外筒内に充填された医療用液体とからなるプレフィルドシリンジと、開口部を有する容器本体と該容器本体の前記開口部を封止するシール部材と前記容器本体内に収納された薬剤とからなる薬剤容器の前記シール部材にてシールされた前記開口部に接続可能なアダプターとからなる薬剤投与具であって、
前記アダプターは、一端側に設けられ、ISO規格に適合したノズル部への接続部を有する医療用具の前記接続部に接続可能な医療用具接続部と、他端側に設けられ、前記プレフィルドシリンジの前記ノズル部が係合可能なシリンジ接続部とを備えるコネクターと、
一端に前記薬剤容器の前記シール部材を貫通可能な刃先部を有する中空針状部と、他端側に設けられ、前記コネクターを着脱可能に接続するコネクター装着部と、前記中空針状部の中央部より他端側を被包する筒状のカラー部とを備える穿刺部材と、
前記シール部材にてシールされた前記開口部に接続可能な薬剤容器装着部と、該装着部より延び、かつ、前記穿刺部材の前記中空針状部が内側にかつ前記カラー部が外側を移動可能な中空針状部収納用筒状部とを有するガイド部材とからなり、
前記穿刺部材と前記ガイド部材は、前記コネクターに前記シリンジを接続した後、前記シリンジを押し込むことにより、前記穿刺部材は前記ガイド部材内を進行し、前記薬剤容器の前記シール部材を刺通するものであり、かつ、前記穿刺部材と前記ガイド部材は、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部を備えていることを特徴とする薬剤投与具。
Form which cannot be connected to the said connection part of a medical device which has the connection part to the nozzle part which was provided in the front-end | tip part of this outer cylinder main-body part and this outer-cylinder main-body part, and the front-end | tip conformed to the ISO standard. An outer cylinder including a nozzle portion having a sealing member, a sealing member for sealing the nozzle portion, a gasket slidably accommodated in the outer cylinder, and attached to or attachable to a rear end of the gasket A prefilled syringe made of a pusher and a medical liquid filled in the outer cylinder, a container body having an opening, a seal member for sealing the opening of the container body, and the container body are housed in the container body. A drug administration device comprising an adapter connectable to the opening sealed by the seal member of a drug container comprising:
The adapter is provided on one end side and provided on the other end side of the medical device connection portion connectable to the connection portion of the medical device having a connection portion to a nozzle portion conforming to ISO standards. A connector provided with a syringe connecting part to which the nozzle part can be engaged;
A hollow needle-like portion having a blade edge portion capable of penetrating the seal member of the drug container at one end; a connector mounting portion provided on the other end side to removably connect the connector; and a center of the hollow needle-like portion A puncture member comprising a cylindrical collar portion encapsulating the other end side from the portion;
A medicine container mounting portion connectable to the opening sealed by the seal member, and extending from the mounting portion, the hollow needle-like portion of the puncture member being movable inward and the collar portion being movable outward A hollow needle-shaped portion storing cylindrical portion and a guide member,
The puncture member and the guide member connect the syringe to the connector, and then push the syringe so that the puncture member advances in the guide member and pierces the seal member of the drug container And the puncture member and the guide member are engaged after the puncture member completes the piercing of the drug container to the seal member, and the puncture member is engaged to suppress the detachment of the puncture member from the guide member. A drug administration device comprising a part.
前記ガイド部材は、前記中空状針状部収納用筒状部の外方に位置し、かつ、前記薬剤容器装着部より前記中空状針状部収納用筒状部の端部方向に延びる外側ガイド部を備え、前記穿刺部材の前記カラー部は、前記外側ガイド部と前記中空針状部収納用筒状部との間隙を移動するものであり、かつ、前記ガイド部材の前記外側ガイド部と前記穿刺部材が、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部を備えている請求項1に記載の薬剤投与具。 The guide member is located outside the hollow needle-like portion storing tubular portion and extends from the drug container mounting portion toward the end of the hollow needle-like portion storing tubular portion. The collar portion of the puncture member moves in a gap between the outer guide portion and the hollow needle-like portion storage tubular portion, and the outer guide portion of the guide member and the The puncture member is provided with an engagement portion that is engaged after the puncture member completes piercing of the drug container to the seal member and suppresses the puncture member from being detached from the guide member. Drug administration device. 前記穿刺部材は、前記カラー部の先端部の内面に設けられた突出部を備え、前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられ、前記穿刺部材の前記突出部を摺動可能に収納しかつ前記筒状部の軸方向かつ前記薬剤容器装着部側より前記中空状針状部収納用筒状部の端部方向に延びる軸方向溝部と、該軸方向溝部内かつ前記装着部側に位置し、前記穿刺部材の突出部と係合可能な係合部を備えており、前記穿刺部材による前記薬剤容器の前記シール部材への刺通完了後に係合し、前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部は、前記穿刺部材の突出部と前記ガイド部材の前記軸方向溝部内の前記係合部とにより構成されているものである請求項1または2に記載の薬剤投与具。 The puncture member includes a protrusion provided on the inner surface of the distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion, and the protrusion of the puncture member An axial groove extending in the axial direction of the cylindrical portion and extending from the side of the drug container mounting portion toward the end of the cylindrical portion for storing the hollow needle-like portion, and in the axial groove portion And an engagement portion that is located on the mounting portion side and is engageable with the protruding portion of the puncture member, is engaged after the puncture member completes piercing of the drug container into the seal member, and The engagement portion that suppresses detachment of the puncture member from the guide member is constituted by a protruding portion of the puncture member and the engagement portion in the axial groove portion of the guide member. Or the drug administration device according to 2. 前記穿刺部材は、前記カラー部の先端部の内面に設けられた突出部を備え、前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられ、前記穿刺部材の前記突出部を摺動可能に収納しかつ前記筒状部の軸方向かつ前記薬剤容器装着部側より前記中空状針状部収納用筒状部の端部方向に延びる軸方向溝部と、該軸方向溝部と連続し、前記筒状部の周方向に延びかつ前記穿刺部材の前記突出部を摺動可能に収納する周方向溝部とを備え、前記穿刺部材の前記突出部は、前記ガイド部材の前記周方向溝部内に位置し、前記穿刺部材の前記カラー部に対する周方向への移動を許容し、かつ、軸方向への移動が規制された状態となっている請求項1ないし3のいずれかに記載の薬剤投与具。 The puncture member includes a protrusion provided on the inner surface of the distal end portion of the collar portion, and the guide member is provided on an outer surface of the hollow needle-like portion storage tubular portion, and the protrusion of the puncture member An axial groove extending in the axial direction of the tubular portion and extending from the side of the medicine container mounting portion toward the end of the hollow needle-shaped tubular portion for accommodating the tubular portion, and the axial groove A circumferential groove that is continuous and extends in the circumferential direction of the tubular portion and slidably accommodates the protruding portion of the puncture member, wherein the protruding portion of the puncture member is in the circumferential direction of the guide member 4. The device according to claim 1, wherein the puncture member is located in the groove portion, allows movement of the puncture member in the circumferential direction with respect to the collar portion, and is restricted in movement in the axial direction. 5. Drug administration device. 前記穿刺部材は、該穿刺部材を前記ガイド部材の前記中空針状部収納用筒状部の周方向に回転させることにより、前記穿刺部材の前記突出部が前記中空針状部収納用筒状部の軸方向溝部内に移動し、前記穿刺部材の前記ガイド部材の前記装着部方向への移動が可能となるものである請求項4に記載の薬剤投与具。 The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member becomes the hollow needle-like portion storage tubular portion. 5. The drug administration device according to claim 4, wherein the drug administration device is capable of moving in the axial groove portion of the puncture member so that the guide member of the puncture member can move in the direction of the mounting portion. 前記外筒は、前記ノズル部に設けられた係合用外側リブを備え、前記コネクターは、外側筒状部と該外側筒状部に形成されるとともに、前記係合用外側リブと係合可能な係合用内側リブとを備え、前記穿刺部材の前記突出部を前記ガイド部材の前記周方向溝部から離脱させるための回転方向は、前記外筒のノズル部の前記係合用外側リブを前記コネクターの前記外側筒状部の係合用内側リブとを係合させるための回転方向と同じである請求項5に記載の薬剤投与具。 The outer cylinder includes an engaging outer rib provided in the nozzle portion, and the connector is formed on the outer cylindrical portion and the outer cylindrical portion, and is engaged with the engaging outer rib. A rotation direction for detaching the protruding portion of the puncture member from the circumferential groove portion of the guide member, and the engaging outer rib of the nozzle portion of the outer cylinder is connected to the outer side of the connector. 6. The drug administration device according to claim 5, wherein the direction of rotation is the same as that for engaging with the engaging inner rib of the cylindrical portion. 前記穿刺部材の前記ガイド部材からの離脱を抑制する係合部は、前記外側ガイド部の自由端側の内面に設けられたリブと、前記穿刺部材の前記コネクター装着部側に設けられ、前記リブと係合する開口部もしくは凹部により構成されている請求項2ないし6のいずれかに記載の薬剤投与具。 The engaging portion that suppresses the puncture member from being detached from the guide member is provided on the inner surface on the free end side of the outer guide portion, and on the connector mounting portion side of the puncture member, and the rib The drug administration device according to any one of claims 2 to 6, wherein the drug administration device is configured by an opening or a recess that engages with the device. 前記外側ガイド部は、向かい合うように2つ設けられており、かつ、それぞれの前記自由端側の内面に前記リブが設けられており、前記穿刺部材は、前記コネクター装着部側に向かい合うように設けられ、かつ、前記リブと係合する開口部もしくは凹部を備えている請求項7に記載の薬剤投与具。 Two outer guide portions are provided so as to face each other, and the ribs are provided on the inner surfaces of the respective free ends, and the puncture member is provided so as to face the connector mounting portion side. The drug administration device according to claim 7, further comprising an opening or a recess that engages with the rib. 前記外筒のノズル部は、前記外筒本体部の先端面より外方に突出する内筒部と、該内筒部を被包するように設けられた外筒部と、該外筒部の外面に設けられた係合用外側リブを備え、前記コネクターは、前記ノズル部の前記内筒部内に侵入可能な内側筒状部と、前記外筒部を収納可能かつ内面に前記係合用外側リブと係合可能な係合用内側リブとを有する外側筒状部とを備えている請求項1ないし8のいずれかに記載の薬剤投与具。 The nozzle portion of the outer cylinder includes an inner cylinder portion that protrudes outward from a front end surface of the outer cylinder main body portion, an outer cylinder portion that is provided so as to enclose the inner cylinder portion, An outer rib for engagement provided on an outer surface; and the connector includes an inner cylindrical portion that can enter the inner tube portion of the nozzle portion; and the outer rib for engagement on the inner surface that can store the outer tube portion. The drug administration device according to any one of claims 1 to 8, further comprising an outer cylindrical portion having an engaging inner rib that can be engaged. 前記ノズル部の前記内筒部の先端部の外径と前記外筒部の先端部の内径の差は、0.5mm〜1.5mmであり、前記外筒部の先端部の内径は、2〜3mmまたは6〜10mmである請求項9に記載の薬剤投与具。 The difference between the outer diameter of the tip of the inner cylinder part of the nozzle part and the inner diameter of the tip of the outer cylinder part is 0.5 mm to 1.5 mm, and the inner diameter of the tip part of the outer cylinder part is 2 mm. The drug administration device according to claim 9, which is -3 mm or 6-10 mm. 前記コネクターと前記穿刺部材は、前記穿刺部材の前記コネクター装着部に装着された前記コネクターが前記穿刺部材に対して回転することを規制する回転規制部を備えている請求項1ないし10のいずれかに記載の薬剤投与具。 The said connector and the said puncture member are provided with the rotation control part which controls that the said connector with which the said connector mounting part of the said puncture member was mounted | worn rotates with respect to the said puncture member. The drug administration device according to 1. 前記穿刺部材は、該穿刺部材を前記ガイド部材の前記中空針状部収納用筒状部の周方向に回転させることにより、前記穿刺部材の前記突出部が前記中空針状部収納用筒状部の前記軸方向溝部内に移動し、前記穿刺部材の前記ガイド部材の前記装着部方向への移動が可能となるものである請求項3ないし11のいずれかに記載の薬剤投与具。 The puncture member rotates the puncture member in the circumferential direction of the hollow needle-like portion storage tubular portion of the guide member, so that the protruding portion of the puncture member becomes the hollow needle-like portion storage tubular portion. The drug administration device according to any one of claims 3 to 11, which moves into the axial groove portion of the guide member and enables the guide member of the puncture member to move in the mounting portion direction. 前記穿刺部材を回転させる前記カラー部の周方向は、前記外筒のノズル部の前記係合用外側リブを前記コネクターの前記外側筒状部の係合用内側リブとを係合させるための回転方向と同じである請求項12に記載の薬剤投与具。 The circumferential direction of the collar portion for rotating the puncture member is a rotation direction for engaging the engaging outer rib of the nozzle portion of the outer cylinder with the engaging inner rib of the outer cylindrical portion of the connector. The drug administration device according to claim 12, which is the same. 前記ガイド部材は、前記中空針状部収納用筒状部の外面に設けられた前記周方向溝部と連続し、前記中空針状部収納用筒状部の自由端まで延びかつ前記穿刺部材の前記突出部を摺動可能に収納する誘導用軸方向溝部を備えている請求項4ないし13のいずれかに記載の薬剤投与具。 The guide member is continuous with the circumferential groove provided on the outer surface of the hollow needle-like storage cylindrical portion, extends to the free end of the hollow needle-like storage cylindrical portion, and the puncture member The drug administration device according to any one of claims 4 to 13, further comprising a guide axial groove for slidably storing the protruding portion. 前記ガイド部材は、前記薬剤容器装着部に設けられ、該装着部に易変形性を付与するためのスリットを備えている請求項1ないし14のいずれかに記載の薬剤投与具。 The drug administration device according to any one of claims 1 to 14, wherein the guide member is provided in the drug container mounting portion and includes a slit for imparting easy deformability to the mounting portion. 請求項1ないし15のいずれかに記載の薬剤投与具と、前記薬剤容器とからなり、かつ、該薬剤投与具が、前記薬剤容器装着部により前記薬剤容器に装着された状態となっている薬剤容器装着済み薬剤投与具。 A drug comprising the drug administration device according to any one of claims 1 to 15 and the drug container, wherein the drug administration tool is mounted on the drug container by the drug container mounting portion. Container-fitted drug administration device.
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