JPH08710A - Liquid introducing needle and auxiliary implement for dissolving dry formulation using the same - Google Patents
Liquid introducing needle and auxiliary implement for dissolving dry formulation using the sameInfo
- Publication number
- JPH08710A JPH08710A JP6159106A JP15910694A JPH08710A JP H08710 A JPH08710 A JP H08710A JP 6159106 A JP6159106 A JP 6159106A JP 15910694 A JP15910694 A JP 15910694A JP H08710 A JPH08710 A JP H08710A
- Authority
- JP
- Japan
- Prior art keywords
- vial
- hub
- needle
- prefilled syringe
- liquid
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
- B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
- B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
Abstract
Description
【０００１】[0001]
【産業上の利用分野】本発明は、筒状支持部材に上下方
向スライド可能に収容され、該筒状部材の両端に位置す
る乾燥製剤容器と溶解液容器を連通して乾燥製剤と溶解
液を無菌的に混合し、注射液を調製するのに適した乾燥
製剤溶解キット用の液体導入針、およびこれを用いた乾
燥製剤溶解補助具に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dry preparation container and a dissolution liquid container, which are accommodated in a cylindrical support member so as to be slidable in the vertical direction and communicate with a dry preparation container and a dissolution liquid container located at both ends of the cylindrical member. The present invention relates to a liquid introduction needle for a dry preparation dissolution kit suitable for aseptically mixing and preparing an injection solution, and a dry preparation dissolution aid using the same.
【０００２】[0002]
【従来の技術】ある種の注射剤はこれらを使用できる状
態にされた場合、急激にその効力を失うため、多くは二
成分として一般に穿刺可能な栓を備えた２本のバイアル
に収容した形で与えられ、用時に注射器などを用いて混
合されている。しかしながら、このような注射器を用い
ての混合操作は、操作が煩雑な上、無菌性に関して問題
を含んでいる。そこで、この様な問題を解決するため
に、本件出願人は、すでに乾燥製剤溶解キットを提案し
ている（特開平５−２７７１５６号公報）。これは、乾
燥製剤が収容されている薬剤バイアルと、溶解液が充填
されるとともにチップ先端が薄膜で閉塞されているプレ
フィルドシリンジと、前記両者を連結して保持するとと
もに連通操作をガイドする連通器具とからなり、該連通
器具は、内周面が円筒状で、軸方向の途中に隔壁が形成
されており、一端側が前記薬剤バイアルの口部を軸方向
に摺動自在に保持するバイアル保持部に形成され、他端
側が前記シリンジの筒部を軸方向に摺動自在に保持する
シリンジ保持部に形成され、前記隔壁に両端に穿刺部を
有する移注針が固定されていることを特徴とするもので
ある。BACKGROUND OF THE INVENTION Certain injectables rapidly lose their potency when they are ready for use, and are therefore often packaged as two components in two vials with pierceable stoppers. It has been mixed with a syringe or the like at the time of use. However, the mixing operation using such a syringe is complicated and has a problem regarding sterility. Therefore, in order to solve such a problem, the applicant of the present invention has already proposed a dry preparation dissolution kit (JP-A-5-277156). This is a drug vial containing a dry preparation, a prefilled syringe filled with a solution and having a tip closed with a thin film, and a communication device for connecting and holding the both and guiding a communication operation. The communication device has a cylindrical inner peripheral surface, a partition wall is formed midway in the axial direction, and a vial holding portion for axially slidably holding the mouth of the drug vial at one end side. The other end side is formed in a syringe holding portion that slidably holds the cylindrical portion of the syringe in the axial direction, and a transfusion needle having puncture portions at both ends is fixed to the partition wall. To do.
【０００３】[0003]
【発明の解決しようとする課題】しかしながら、上記の
乾燥製剤溶解キットは、移注針のバイアルのゴム栓を刺
通する側の刃先がベベル状に形成されているので、ゴム
栓を刺通する際にコアリングを生ずる虞があり、また、
ゴム栓側の刺通抵抗がプレフィルドシリンジの薄膜側の
刺通抵抗より大きいため、バイアルの内部とプレフィル
ドシリンジの内部を素早く連通しないと、先にプレフィ
ルドシリンジ側が連通して溶解液が漏れる虞があった。
本発明は上記の課題を解決するもので、バイアルのゴム
栓を刺通した時にコアリングを生ずることがなく、ま
た、バイアルとプレフィルドシリンジの連通時に溶解液
のリークが生ずることのない乾燥製剤溶解補助具を提供
することを目的とする。また、この乾燥製剤溶解補助具
に好適な液体導入針を提供することを目的とする。However, in the above-mentioned dry preparation dissolving kit, since the blade end of the transfusing needle through which the rubber stopper of the vial is inserted is formed in a bevel shape, the rubber stopper is pierced. May cause coring, and
Since the piercing resistance on the rubber stopper side is larger than the piercing resistance on the thin film side of the prefilled syringe, unless the inside of the vial and the inside of the prefilled syringe are quickly connected, the prefilled syringe side may be connected first and the solution may leak. It was
The present invention is to solve the above-mentioned problems, and does not cause coring when a rubber stopper of a vial is pierced, and does not cause leakage of a dissolution liquid during communication between a vial and a prefilled syringe. The purpose is to provide auxiliary equipment. Moreover, it aims at providing the liquid introduction needle suitable for this dry formulation dissolution aid.
【０００４】[0004]
【課題を解決するための手段】本発明は上記の課題を解
決するために、筒状支持部材に上下方向スライド可能に
収容され、該筒状部材の両端に位置する乾燥製剤容器と
溶解液容器を連通して乾燥製剤を溶解する乾燥製剤溶解
キット用の中空の穿刺針であって、上下両端に刃先を有
するとともに中間部に該穿刺針を上下に分画するハブが
設けられており、該ハブより下側の部分の刃先が閉塞さ
れ、その刃先からハブ方向にテーパ状に拡径された部分
を有し、さらに該拡径部分の側壁に側孔が設けられ、該
側孔およびハブより上側の刃先に薬液通路が開口する液
体導入針において、ハブに該液体導入針の軸と直角方向
に延び前記筒状支持部材の内壁とスライド可能に係合す
る複数の係合腕を設けるとともに、前記拡径部分の側孔
をゴム状弾性体製の密封部材でスライド可能かつ流体密
に閉鎖し、該密封部材をハブ方向にスライド移動させた
時に側孔が開口するようにしてなる液体導入針を採用し
ている。また、両端の開口した筒状容器であって、一方
の開口部に筒状容器と該筒状容器の開口から挿着される
プレフィルドシリンジとの間をシールするシール部材を
装着し、該開口から挿着されたプレフィルドシリンジを
長手方向にスライド可能かつ流体密に保持できるように
するとともに、他端の開口部にバイアルを固定するバイ
アル固定手段を設け、バイアルの少なくとも口部を収容
して保持できるようにしたガイドカプセルに、前記液体
導入針をハブより上側の刃先をプレフィルドシリンジ挿
着用開口側に向けかつ長手方向にスライド可能に収容し
てなる乾燥製剤溶解補助具を採用している。液体導入針
については、拡径部分のハブ側端部に環状リブを設ける
とともに、環状リブとハブの距離を密封部材の長さより
長く形成するのが好ましい。また、乾燥製剤溶解補助具
においては、液体導入針の上部刃先側に環状リブを設け
るとともに、ハブに当接し該環状リブによって係止され
るようにゴムキャップを装着し、該ゴムキャップでプレ
フィルドシリンジのチップをシールするようにしてもよ
い。In order to solve the above-mentioned problems, the present invention is accommodated in a tubular support member so as to be slidable in the vertical direction, and a dry preparation container and a solution container which are located at both ends of the tubular member. A hollow puncture needle for a dry formulation dissolution kit for communicating a dry formulation by communicating with each other, having a cutting edge at both upper and lower ends and a hub for dividing the puncture needle up and down in an intermediate portion, The blade tip of the portion below the hub is closed, and the blade tip has a portion that is expanded in the hub direction in a taper shape. Further, a side hole is provided in the side wall of the expanded diameter portion, and the side hole and the hub In the liquid introduction needle having the chemical liquid passage opening at the upper blade edge, the hub is provided with a plurality of engagement arms extending in the direction perpendicular to the axis of the liquid introduction needle and slidably engaged with the inner wall of the cylindrical support member, The side hole of the expanded portion is made of rubber-like elastic material Slidable sealing member and is closed in fluid-tight, the side hole is employed a liquid introducing needle comprising so as to be opened when the slide moves said sealing member to the hub direction. Further, in a cylindrical container having openings at both ends, a sealing member for sealing between the cylindrical container and a prefilled syringe inserted from the opening of the cylindrical container is attached to one opening, The inserted pre-filled syringe is slidable in the longitudinal direction and can be fluid-tightly held, and vial fixing means for fixing the vial is provided at the opening at the other end to accommodate and hold at least the mouth of the vial. In such a guide capsule, there is employed a dry formulation dissolution assisting tool in which the liquid introduction needle is housed so that the blade edge above the hub is slidable in the longitudinal direction with the blade end facing the prefilled syringe insertion opening side. With respect to the liquid introduction needle, it is preferable that an annular rib is provided at the end of the enlarged diameter portion on the hub side, and the distance between the annular rib and the hub is longer than the length of the sealing member. In addition, in the dry formulation dissolution aid, an annular rib is provided on the upper cutting edge side of the liquid introduction needle, and a rubber cap is attached so as to abut the hub and be locked by the annular rib, and the prefilled syringe is attached with the rubber cap. The tip may be sealed.
【０００５】[0005]
【作用】上記構成の乾燥製剤溶解補助具によれば、先
ず、乾燥製剤溶解補助具の一方の開口部に、内部に溶解
液が充填されるとともにそのチップ先端が薄膜で閉塞さ
れてなるプレフィルドシリンジの先端のチップ側を挿着
し、次いで、乾燥製剤溶解補助具の他方の開口部にバイ
アルの口部を固定する（図８参照）。次に、プレフィル
ドシリンジとバイアルを乾燥製剤溶解補助具にセットし
たものを机の上などに例えばプレフィルドシリンジが上
になるようにして立て、プレフィルドシリンジを下に押
すと、プレフィルドシリンジの薄膜とバイアルのゴム栓
はそれぞれ液体導入針のハブより上側の刃先とハブより
下側の刃先で刺通され、プレフィルドシリンジの内部と
バイアルの内部は液体導入針を介して液体連通される
（図９参照）。この時、プレフィルドシリンジのガスケ
ットにプランジャを取り付け、プランジャを押すと、プ
レフィルドシリンジ内の溶解液はバイアル側に流入する
ので、例えばバイアルを振って、またはプランジャを押
したり引いたりしてバイアル内の乾燥製剤を溶解液と混
合すれば薬液が調製される。次いで、プランジャを手前
に引いて調製された薬液をプレフィルドシリンジ内に吸
入し、プレフィルドシリンジを乾燥製剤溶解補助具から
取り外せば（図１０参照）、チップに注射針を装着して
薬液を患者に注射することができる。According to the dry drug product dissolution aid having the above-mentioned structure, first, one opening of the dry drug product dissolution aid device is filled with the solution inside and the tip of the tip is closed with a thin film. The tip side of the above is inserted, and then the mouth of the vial is fixed to the other opening of the dry formulation dissolution aid (see FIG. 8). Next, the prefilled syringe and the vial set in the dry formulation dissolution aid are erected on a desk, for example, with the prefilled syringe facing up, and when the prefilled syringe is pushed downward, the thin film of the prefilled syringe and the vial The rubber stoppers are pierced by the blade tip of the liquid introduction needle above the hub and the blade tip below the hub, respectively, and the inside of the prefilled syringe and the inside of the vial are in fluid communication through the liquid introduction needle (see FIG. 9). At this time, when the plunger is attached to the gasket of the prefilled syringe and the plunger is pushed, the dissolution liquid in the prefilled syringe flows into the vial side.For example, shake the vial or push or pull the plunger to dry the inside of the vial. A drug solution is prepared by mixing the formulation with the solution. Then, pull the plunger toward you, inhale the prepared drug solution into the prefilled syringe, remove the prefilled syringe from the dry formulation dissolution aid (see FIG. 10), and attach the injection needle to the tip to inject the drug solution into the patient. can do.
【０００６】ここで、本発明の液体導入針は、そのハブ
より下側の部分の刃先が閉塞され、その刃先からハブ方
向にテーパ状に拡径された部分を有し、さらにこの拡径
部分の側壁に側孔が設けられているので、このハブより
下側の刃先でバイアルのゴム栓を刺通してもコアリング
を生ずることがない。また、液体導入針のハブより下側
の部分の側孔およびハブより上側の刃先に薬液通路が開
口しており、側孔がゴム状弾性体製の密封部材でスライ
ド可能かつ流体密に閉鎖されているので、液体導入針の
ハブより下側の刃先でバイアルのゴム栓を刺通するより
も先にハブより上側の刃先がプレフィルドシリンジの薄
膜を刺通しても溶解液がリークすることがない。In the liquid introducing needle of the present invention, the blade tip of the portion below the hub is closed, and there is a portion that is tapered in the hub direction from the blade tip. Since a side hole is provided in the side wall of the vial, coring does not occur even if the rubber stopper of the vial is pierced by the blade tip below the hub. Further, a chemical liquid passage is opened in a side hole of a portion of the liquid introducing needle below the hub and a cutting edge above the hub, and the side hole is slidably and fluid-tightly closed by a rubber-like elastic sealing member. Therefore, even if the blade tip above the hub pierces the thin film of the prefilled syringe before the rubber tip of the vial is pierced with the blade tip below the hub of the liquid introduction needle, the solution does not leak.
【０００７】[0007]
【実施例】次に本発明の実施例について図面に基づいて
説明する。図１は本第１の発明の一実施例に係る液体導
入針の一部断面側面図であり、図２は図１に示す穿刺針
の平面図、図３は図１に示す穿刺針の底面図、図４は図
１に示す穿刺針の右側面図、図５は図１に示す穿刺針の
図２におけるＸ−Ｘ線断面図である。また、図６は本第
２の発明の一実施例に係る乾燥製剤溶解補助具の断面
図、図７は図６に示すガイドカプセルの断面図であり、
図８は図６に示す乾燥製剤溶解補助具にバイアルとプレ
フィルドシリンジを装着した状態を示す図、図９は図８
において乾燥製剤溶解補助具の液体導入針を介してバイ
アルとプレフィルドシリンジを連通した状態を示す図、
図１０は図９において乾燥製剤溶解補助具からプレフィ
ルドシリンジを取り外した状態を示す図である。Embodiments of the present invention will now be described with reference to the drawings. FIG. 1 is a partial cross-sectional side view of a liquid introducing needle according to an embodiment of the first invention, FIG. 2 is a plan view of the puncture needle shown in FIG. 1, and FIG. 3 is a bottom view of the puncture needle shown in FIG. FIG. 4, FIG. 4 is a right side view of the puncture needle shown in FIG. 1, and FIG. 5 is a sectional view of the puncture needle shown in FIG. FIG. 6 is a sectional view of a dry preparation dissolution aid according to an embodiment of the second invention, and FIG. 7 is a sectional view of the guide capsule shown in FIG.
8 is a view showing a state in which a vial and a prefilled syringe are attached to the dry formulation dissolution aid shown in FIG. 6, and FIG. 9 is shown in FIG.
In, a view showing a state in which the vial and the prefilled syringe are communicated with each other via the liquid introduction needle of the dry formulation dissolution aid,
FIG. 10 is a view showing a state in which the prefilled syringe is removed from the dry formulation dissolution aid in FIG. 9.
【０００８】先ず、第１の発明について説明する。図１
に示すように本第１の発明の液体導入針ＴＮは、上下両
端に刃先１２、１３を有する中空の穿刺針１１とこの穿
刺針１１の中間部分に設けられたハブ１４からなる液体
導入針本体１と、この穿刺針１１の下部刃先１３側に形
成された側孔１７を塞ぐ密封部材（ゴムキャップ２）か
ら構成されており、薬液通路１８は上部刃先１２と側孔
１７に開口している。側孔１７は薬液通路１８の下部刃
先１３側の開口であり、図３〜５に示すように、下部刃
先１３からハブ１４方向にテーパ状に拡径された部分の
側壁に通常２〜４個形成される。First, the first invention will be described. FIG.
As shown in FIG. 1, the liquid introduction needle TN of the first invention is a liquid introduction needle main body composed of a hollow puncture needle 11 having cutting edges 12 and 13 at both upper and lower ends and a hub 14 provided at an intermediate portion of the puncture needle 11. 1 and a sealing member (rubber cap 2) that closes the side hole 17 formed on the lower cutting edge 13 side of the puncture needle 11, and the chemical liquid passage 18 is opened to the upper cutting edge 12 and the side hole 17. . The side holes 17 are openings on the lower blade edge 13 side of the chemical liquid passage 18, and as shown in FIGS. 3 to 5, usually 2 to 4 holes are formed on the side wall of the portion tapered from the lower blade edge 13 toward the hub 14. It is formed.
【０００９】液体導入針本体１は一般に高摺動性ポリエ
チレン樹脂、ポリプロピレン、ＡＢＳ樹脂、ポリカーボ
ネートなどの可撓性樹脂で形成されている。穿刺針１１
をステンレス等の金属で形成し、前記のような可撓性樹
脂で形成されたハブ１４と一体に組み立ててもよい。穿
刺針１１は上下両端に刃先１２、１３を有する中空針で
あって、ハブ１４によって上下に分かたれており、図１
〜５に示すように、上部刃先１２が開放されベベル状に
形成されるとともに、下部刃先１３が閉塞されロケット
の先端形状に形成されている。そして穿刺針１１の下部
は閉塞した刃先１３からハブ１４方向にテーパ状に拡径
する拡径部分を有しており、この拡径部分の側壁に薬液
通路１８の開口としての側孔１７が形成されている。そ
して、側孔１７よりハブ１４側には、この側孔１７を閉
鎖するべく拡径部分に装着されたゴムキャップ２のハブ
１４方向への意図しないスライドを制限するために、環
状リブ１９が設けられている。環状リブ１９とハブ１４
との距離は、ゴムキャップ２の長さと同等またはそれよ
り若干長く決められる。The liquid introducing needle body 1 is generally made of a flexible resin such as a high slidability polyethylene resin, polypropylene, ABS resin, or polycarbonate. Puncture needle 11
May be formed of a metal such as stainless steel and assembled integrally with the hub 14 formed of the flexible resin as described above. The puncture needle 11 is a hollow needle having cutting edges 12 and 13 at both upper and lower ends, and is divided vertically by a hub 14, as shown in FIG.
5 to 5, the upper cutting edge 12 is opened and formed into a bevel shape, and the lower cutting edge 13 is closed and formed into a rocket tip shape. The lower portion of the puncture needle 11 has a diameter-expanded portion that tapers from the closed blade edge 13 toward the hub 14, and a side hole 17 as an opening of the drug solution passage 18 is formed on the side wall of this diameter-expanded portion. Has been done. An annular rib 19 is provided on the hub 14 side of the side hole 17 in order to limit the unintentional sliding of the rubber cap 2 attached to the enlarged diameter portion in the direction of the hub 14 to close the side hole 17. Has been. Annular rib 19 and hub 14
The distance between and is set to be equal to or slightly longer than the length of the rubber cap 2.
【００１０】ハブ１４は通常円板状または図２〜３に示
すような十字状に形成され、ハブ１４の周縁には、軸に
対して対称に通常２個または４個の係合腕１５が設けら
れている。この係合腕１５は液体導入針ＴＮを後述の乾
燥製剤溶解補助具のガイドカプセル３の軸方向に真っ直
ぐに保持させるとともに、ガイドカプセル３に沿ってス
ムーズに下方移動できるようにするものであって、通
常、その先端に外側に突出する係合突起１６が形成され
ている。この係合突起１６はガイドカプセル３の内壁に
形成された段部３６と係合するようになっており、少な
くとも係合腕１５を含むハブ１４が可撓性樹脂で形成さ
れているので、バイアルのゴム栓を乾燥製剤溶解補助具
に収容された液体導入針ＴＮの上部刃先１２側にあてが
って下方に押した時に、係合腕１５が内側に撓んで係合
突起１６がガイドカプセル３の段部３６から外れ、液体
導入針ＴＮが下方に移動するようになっている。The hub 14 is usually formed in a disc shape or in a cross shape as shown in FIGS. 2 and 3, and two or four engaging arms 15 are symmetrically provided with respect to the axis on the periphery of the hub 14. It is provided. The engaging arm 15 holds the liquid introduction needle TN in a straight line in the axial direction of the guide capsule 3 of the dry formulation dissolution aid described later, and allows the liquid introduction needle TN to move smoothly along the guide capsule 3. Usually, an engagement protrusion 16 is formed at the tip of the protrusion so as to protrude outward. The engagement protrusion 16 is adapted to engage with the stepped portion 36 formed on the inner wall of the guide capsule 3, and since the hub 14 including at least the engagement arm 15 is formed of a flexible resin, the vial is formed. When the rubber stopper is applied to the upper edge 12 side of the liquid introduction needle TN housed in the dry formulation dissolution aid and pushed downward, the engagement arm 15 bends inward and the engagement projection 16 is a step of the guide capsule 3. The liquid introducing needle TN moves away from the portion 36 and moves downward.
【００１１】次に、本第２の発明について説明する。図
６に示すように本第２の発明の乾燥製剤溶解補助具は、
両端にそれぞれプレフィルドシリンジの先端側を挿着す
る開口部３４と、バイアルの口部を挿着する開口部３５
を有するガイドカプセル３と、これにスライド可能に収
容された液体導入針ＴＮからなり、開口部３４、３５は
それぞれカバーシール５１、５２で密封されている。そ
して、開口部３４の内壁には、図７に示すように、パッ
キン挿着用環状溝３３が形成されており、このパッキン
挿着用環状溝３３にはプレフィルドシリンジの胴部とガ
イドカプセル３の内壁との間をシールするためのパッキ
ン（通常Ｏリング）４が嵌め込まれている。また、開口
部３５の内壁には、バイアル挿着時にバイアルが液体導
入針ＴＮと接触しないように、バイアルの侵入を制限す
る隔壁３１が設けられており、この隔壁３１には、中央
部に穿刺針１１の下部を通過させることのできる透孔３
２が形成されるとともに、開口部３５の開放端側にガイ
ドカプセル３の内壁に近接してこれと並行に、開口部３
５に挿着されたバイアルが穿刺針１１を刺通した時に後
退して脱落しないように固定するためのバイアル固定手
段３７が設けられている。このバイアル固定手段３７
は、例えば図６〜７に示すように、腕部３７１とフック
３７２からなり、ガイドカプセル３の内壁に近接してこ
れと並行に、通常、ガイドカプセル３の長手軸と対称に
２個以上、好ましくは３〜４個形成される。フック３７
２は腕部３７１の先端から内側に突設された突起であ
り、図では、外側から内側に向かって隔壁３１方向に傾
斜した部分３７３を有しており、バイアルを挿着し易
く、挿着後は外れにくい構造になっている。Next, the second invention will be described. As shown in FIG. 6, the dry formulation dissolution aid of the second invention is
An opening 34 for inserting the tip side of the prefilled syringe into each end and an opening 35 for inserting the mouth of the vial.
And a liquid introduction needle TN slidably accommodated in the guide capsule 3, and the openings 34 and 35 are sealed by cover seals 51 and 52, respectively. As shown in FIG. 7, a packing insertion annular groove 33 is formed on the inner wall of the opening 34, and the packing insertion annular groove 33 includes the body of the prefilled syringe and the inner wall of the guide capsule 3. A packing (usually an O-ring) 4 for sealing the gap is fitted. Further, a partition wall 31 is provided on the inner wall of the opening 35 to restrict the entry of the vial so that the vial does not come into contact with the liquid introduction needle TN when the vial is inserted. Through hole 3 that allows the lower part of the needle 11 to pass therethrough
2 is formed, and on the open end side of the opening 35, close to and parallel to the inner wall of the guide capsule 3, the opening 3 is formed.
There is provided vial fixing means 37 for fixing the vial inserted in 5 so as not to fall back and drop when the puncture needle 11 is pierced. This vial fixing means 37
Is composed of an arm portion 371 and a hook 372, for example, as shown in FIGS. 6 to 7, close to the inner wall of the guide capsule 3 and in parallel therewith, usually two or more, symmetrically with the longitudinal axis of the guide capsule 3, Preferably 3-4 pieces are formed. Hook 37
Reference numeral 2 denotes a protrusion protruding inward from the tip of the arm portion 371, and has a portion 373 inclined in the direction of the partition wall 31 from the outside to the inside in the figure, so that the vial can be easily inserted and inserted. After that, it has a structure that does not come off easily.
【００１２】ガイドカプセル３は通常、筒状に形成さ
れ、液体導入針ＴＮおよびプレフィルドシリンジがスム
ーズにスライド出来るようになっている。そして、ガイ
ドカプセル３の中間部分の内壁には、液体導入針ＴＮの
下方向（隔壁３１の方向）への意図しない移動を防ぐた
めに段部３６が設けられており、また液体導入針ＴＮの
上方向への意図しない移動を防ぐために環状リブ３８が
設けられている。段部３６は液体導入針ＴＮの係合突起
１６と係合して液体導入針ＴＮの下方向への移動を制動
するものであり、バイアルのゴム栓を乾燥製剤溶解補助
具に収容された液体導入針ＴＮの上部刃先１２側にあて
がって下方に押した時に、係合腕１５が内側に撓んで係
合突起１６がガイドカプセル３の段部３６から外れ、液
体導入針ＴＮが下方に移動するようになっているが、乾
燥製剤溶解補助具の製造に際しては、液体導入針ＴＮの
位置決めを行うのに重要な働きをしている。The guide capsule 3 is usually formed in a tubular shape so that the liquid introduction needle TN and the prefilled syringe can slide smoothly. A step portion 36 is provided on the inner wall of the middle portion of the guide capsule 3 in order to prevent unintended movement of the liquid introduction needle TN downward (toward the partition wall 31). Annular ribs 38 are provided to prevent unintentional movement in the direction. The step portion 36 engages with the engagement protrusion 16 of the liquid introduction needle TN to brake the downward movement of the liquid introduction needle TN, and the rubber stopper of the vial is used to store the liquid contained in the dry preparation dissolution aid. When applied downward to the upper cutting edge 12 side of the introduction needle TN and pushed downward, the engagement arm 15 bends inward, the engagement projection 16 is disengaged from the stepped portion 36 of the guide capsule 3, and the liquid introduction needle TN moves downward. However, it plays an important role in positioning the liquid introduction needle TN when manufacturing the dry formulation dissolution aid.
【００１３】乾燥製剤溶解補助具に収容される液体導入
針ＴＮには、開口部３４側から挿着されるプレフィルド
シリンジのチップをシールしてこの部分からの薬液のリ
ークを防止するために、上部刃先１２側にゴムキャップ
６を装着してもよい。ゴムキャップ６は天面６１と液体
導入針ＴＮの上部刃先１２側を挿着するための透孔６２
およびこの透孔６２と同心状に形成されたチップ挿着溝
６３を有している。透孔６２は液体導入針ＴＮの上部刃
先１２側の外径よりやや小さな内径を有しており、チッ
プ挿着溝６１は液体導入針ＴＮの上部刃先１２側の外径
よりも大きくこれに挿着されるプレフィルドシリンジの
チップの外径よりやや小さな内径を有している。そし
て、上部刃先１２側にゴムキャップ６を装着する場合に
は、液体導入針ＴＮの上部刃先１２側の外壁に、ハブ１
４からの距離が丁度天面６１の厚さ（透孔６２の長さ）
に相当する位置に、環状リブ１０１を設けるのが好まし
い。この環状リブ１０１によって、プレフィルドシリン
ジを乾燥製剤溶解補助具から取り外す際に、ゴムキャッ
プ６がチップと一緒に液体導入針ＴＮから外れるのを防
止することができる。The liquid introduction needle TN housed in the dry formulation dissolution aid is sealed with the tip of the prefilled syringe inserted from the opening 34 side to prevent the leakage of the drug solution from this portion. The rubber cap 6 may be attached to the cutting edge 12 side. The rubber cap 6 has a through hole 62 for inserting the top surface 61 and the upper cutting edge 12 side of the liquid introduction needle TN.
And a chip insertion groove 63 formed concentrically with the through hole 62. The through hole 62 has an inner diameter slightly smaller than the outer diameter of the liquid introduction needle TN on the upper blade tip 12 side, and the tip insertion groove 61 is larger than the outer diameter of the liquid introduction needle TN on the upper blade tip 12 side. It has an inner diameter slightly smaller than the outer diameter of the tip of the prefilled syringe to be attached. When the rubber cap 6 is attached to the upper blade tip 12 side, the hub 1 is attached to the outer wall of the liquid introducing needle TN on the upper blade tip 12 side.
The distance from 4 is just the thickness of the top surface 61 (the length of the through hole 62)
It is preferable to provide the annular rib 101 at a position corresponding to. This annular rib 101 can prevent the rubber cap 6 together with the tip from coming off from the liquid introduction needle TN when the prefilled syringe is removed from the dry formulation dissolution aid.
【００１４】次に本第２の発明の乾燥製剤溶解補助具の
使用について図８〜１０を用いて説明する。先ず、乾燥
製剤溶解補助具Ａの開口部３４、３５からそれぞれプレ
フィルドシリンジ７の先端側とバイアル８の口部８２を
装着して図８に示すような状態にする。次に、図８の状
態の乾燥製剤溶解補助具Ａ、プレフィルドシリンジ７、
バイアル８の組立体を例えばバイアル８側を下にして机
などに置き、プレフィルドシリンジ７を下方に押すと、
プレフィルドシリンジ７はガイドカプセル３の内壁に沿
って下方にスライドし、そのチップ７１の開口を閉塞し
ている薄膜（閉塞膜）７２とバイアル８のゴム栓８１は
それぞれ液体導入針ＴＮの上部刃先１２と下部刃先１３
で刺通され、プレフィルドシリンジ７の内部とバイアル
８の内部は液体導入針ＴＮを介して液体連通される（図
９参照）。この時、プレフィルドシリンジ７のガスケッ
ト７３にプランジャ７４を取り付け、プランジャ７４を
押すと、プレフィルドシリンジ７内の溶解液（図示して
いない）はバイアル８側に流入するので、バイアル８を
振って、またはプランジャ７４を押したり引いたりして
バイアル８内の乾燥製剤（図示していない）を溶解液と
混合すれば薬液が調製される。次いで、プランジャ７４
を手前に引いて調製された薬液をプレフィルドシリンジ
７内に吸入し、プレフィルドシリンジ７を乾燥製剤溶解
補助具Ａから取り外せば（図１０参照）、チップ７１に
注射針（図示していない）を装着して薬液を患者に注射
することができる。Next, the use of the dry formulation dissolution aid of the second invention will be described with reference to FIGS. First, the tip end side of the prefilled syringe 7 and the mouth portion 82 of the vial 8 are attached from the openings 34 and 35 of the dry preparation dissolution aid A, respectively, to obtain the state shown in FIG. Next, the dry formulation dissolution aid A, the prefilled syringe 7, and the state shown in FIG.
When the assembly of the vial 8 is placed on a desk or the like with the vial 8 side down, and the prefilled syringe 7 is pushed downward,
The prefilled syringe 7 slides downward along the inner wall of the guide capsule 3, and the thin film (closing film) 72 that closes the opening of the tip 71 and the rubber stopper 81 of the vial 8 are respectively the upper cutting edge 12 of the liquid introduction needle TN. And lower cutting edge 13
And the inside of the prefilled syringe 7 and the inside of the vial 8 are in fluid communication with each other via the liquid introduction needle TN (see FIG. 9). At this time, when the plunger 74 is attached to the gasket 73 of the prefilled syringe 7 and the plunger 74 is pushed, the solution (not shown) in the prefilled syringe 7 flows into the vial 8 side, so shake the vial 8 or The drug solution is prepared by pushing or pulling the plunger 74 to mix the dry formulation (not shown) in the vial 8 with the solution. Then the plunger 74
When the pre-filled syringe 7 is removed from the dry formulation dissolution aid A (see FIG. 10), the tip 71 is fitted with an injection needle (not shown). Then, the drug solution can be injected into the patient.
【００１５】[0015]
【発明の効果】以上説明してきたことから明らかなよう
に、本第１の発明の液体導入針は、そのハブより下側の
部分の刃先が閉塞され、その刃先からハブ方向にテーパ
状に拡径された部分を有し、さらにこの拡径部分の側壁
に側孔が設けられた構成になっているので、このハブよ
り下側の刃先でバイアルのゴム栓を刺通してもコアリン
グを生ずることがない。また、液体導入針のハブより下
側の部分の側孔およびハブより上側の刃先に薬液通路が
開口しており、側孔がゴム状弾性体製の密封部材でスラ
イド可能かつ流体密に閉鎖されているので、溶解液がリ
ークすることがない。また、本第２の発明の乾燥製剤溶
解補助具は、一方の開口部に筒状容器と該筒状容器の開
口から挿着されるプレフィルドシリンジとの間をシール
するシール部材を装着し、該開口から挿着されたプレフ
ィルドシリンジを長手方向にスライド可能かつ流体密に
保持できるようにするとともに、他端の開口部にバイア
ルを液密に固定するバイアル固定手段を設け、バイアル
の少なくとも口部を収容して液密に保持できるようにし
たガイドカプセルに、第１の発明の液体導入針をハブよ
り上側の刃先をプレフィルドシリンジ挿着用開口側に向
けかつ長手方向にスライド可能に収容した構成になって
いるので、バイアルを下にして単にプレフィルドシリン
ジを押し下げるだけの簡単な操作でプレフィルドシリン
ジの内部とバイアルの内部を無菌的に液体連通すること
ができる。また、液体連通時にゴム栓のコアリングや薬
液のリークなどの問題を生ずることがない。As is apparent from the above description, in the liquid introducing needle of the first aspect of the present invention, the blade tip of the portion below the hub is closed, and the blade is expanded from the blade tip toward the hub in a tapered shape. Since it has a diametrical portion and a side hole is provided in the side wall of this expanded diameter portion, coring occurs even if the rubber stopper of the vial is pierced with the blade tip below this hub. There is no. Further, a chemical liquid passage is opened in a side hole of a portion of the liquid introducing needle below the hub and a cutting edge above the hub, and the side hole is slidably and fluid-tightly closed by a rubber-like elastic sealing member. Therefore, the solution does not leak. The dry formulation dissolution aid of the second aspect of the present invention is equipped with a seal member for sealing between a cylindrical container and a prefilled syringe inserted through the opening of the cylindrical container at one opening, The prefilled syringe inserted from the opening is slidable in the longitudinal direction and can be held fluid-tight, and a vial fixing means for fixing the vial liquid-tight is provided at the opening at the other end, and at least the mouth of the vial is provided. A guide capsule adapted to be held in a liquid-tight manner is configured such that the liquid introduction needle of the first invention is accommodated in such a manner that a blade edge above a hub is slidable in a longitudinal direction toward a prefilled syringe insertion opening side. As a result, the inside of the prefilled syringe and the inside of the vial are aseptically liquidized by a simple operation of simply pressing down the prefilled syringe with the vial facing down. It is possible to communicate with each other. Moreover, problems such as coring of the rubber stopper and leakage of the chemical liquid do not occur when the liquid is communicated.
【図１】本第１の発明の一実施例に係る液体導入針の一
部断面側面図である。FIG. 1 is a partial cross-sectional side view of a liquid introduction needle according to an embodiment of the present first invention.
【図２】図１に示す穿刺針の平面図である。FIG. 2 is a plan view of the puncture needle shown in FIG.
【図３】図１に示す穿刺針の底面図である。FIG. 3 is a bottom view of the puncture needle shown in FIG.
【図４】図１に示す穿刺針の右側面図である。FIG. 4 is a right side view of the puncture needle shown in FIG.
【図５】図１に示す穿刺針の図２におけるＸ−Ｘ線断面
図である。5 is a cross-sectional view of the puncture needle shown in FIG. 1 taken along line XX in FIG.
【図６】本第２の発明の一実施例に係る乾燥製剤溶解補
助具の断面図である。FIG. 6 is a cross-sectional view of a dry formulation dissolution aid according to an example of the second invention.
【図７】図６に示すガイドカプセルの断面図である。7 is a cross-sectional view of the guide capsule shown in FIG.
【図８】図６に示す乾燥製剤溶解補助具にバイアルとプ
レフィルドシリンジを装着した状態を示す図である。8 is a diagram showing a state in which a vial and a prefilled syringe are attached to the dry formulation dissolution aid shown in FIG.
【図９】図８において乾燥製剤溶解補助具の液体導入針
を介してバイアルとプレフィルドシリンジを連通した状
態を示す図である。FIG. 9 is a view showing a state in which a vial and a prefilled syringe are communicated with each other via a liquid introduction needle of the dry formulation dissolution aid in FIG.
【図10】図９において乾燥製剤溶解補助具からプレフィ
ルドシリンジを取り外した状態を示す図である。FIG. 10 is a diagram showing a state in which a prefilled syringe is removed from the dry formulation dissolution aid in FIG. 9.
ＴＮ 液体導入針 １ 液体導入針本体 １１ 穿刺針 １４ ハブ １５ 係合腕 １７ 側孔 １８ 薬液通路 １９ 環状リブ ２ ゴムキャップ（密封部材） Ａ 乾燥製剤溶解補助具 ３ ガイドカプセル ３１ 隔壁 ３２ 透孔 ３６ 段部 ３７ バイアル固定手段 ４ パッキン（シール部材） ６ ゴムキャップ ７ プレフィルドシリンジ ８ バイアル TN liquid introduction needle 1 liquid introduction needle main body 11 puncture needle 14 hub 15 engaging arm 17 side hole 18 drug solution passageway 19 annular rib 2 rubber cap (sealing member) A dry formulation dissolution aid 3 guide capsule 31 partition wall 32 through hole 36 steps Part 37 Vial fixing means 4 Packing (seal member) 6 Rubber cap 7 Prefilled syringe 8 Vial
フロントページの続き (51)Int.Cl.6 識別記号 庁内整理番号 ＦＩ 技術表示箇所 Ｂ６５Ｄ 25/08 (72)発明者 八木 秀樹 大阪市北区本庄西３丁目９番３号 株式会 社ニッショー内Continuation of the front page (51) Int.Cl. 6 Identification number Internal reference number FI Technical display location B65D 25/08 (72) Inventor Hideki Yagi 3-9-3 Honjo Nishi, Kita-ku, Osaka City In stock company Nissha
Claims (4)
収容され、該筒状部材の両端に位置する乾燥製剤容器と
溶解液容器を連通して乾燥製剤を溶解する乾燥製剤溶解
キット用の中空の穿刺針であって、上下両端に刃先を有
するとともに中間部に該穿刺針を上下に分画するハブが
設けられており、該ハブより下側の部分の刃先が閉塞さ
れ、その刃先からハブ方向にテーパ状に拡径された部分
を有し、さらに該拡径部分の側壁に側孔が設けられ、該
側孔およびハブより上側の刃先に薬液通路が開口する液
体導入針において、ハブに該液体導入針の軸と直角方向
に延び前記筒状支持部材の内壁とスライド可能に係合す
る複数の係合腕を設けるとともに、前記拡径部分の側孔
をゴム状弾性体製の密封部材でスライド可能かつ流体密
に閉鎖し、該密封部材をハブ方向にスライド移動させた
時に側孔が開口するようにしてなる液体導入針。1. A hollow for a dry preparation dissolution kit, which is accommodated in a tubular support member so as to be slidable in the vertical direction, and which connects a dry preparation container located at both ends of the tubular member with a dissolution liquid container to dissolve the dry preparation. A puncture needle having a cutting edge at both upper and lower ends and a hub for dividing the puncture needle up and down is provided in an intermediate portion, and the cutting edge of a portion below the hub is closed, and the hub is cut from the cutting edge. In a liquid introduction needle having a portion that is tapered in the direction, the side wall of the enlarged diameter portion is provided with a side hole, and a chemical liquid passage is opened at the blade tip above the side hole and the hub. A plurality of engaging arms that extend in a direction perpendicular to the axis of the liquid introducing needle and slidably engage with the inner wall of the cylindrical support member are provided, and the side holes of the enlarged diameter portion are made of rubber-like elastic sealing members. Slidable and fluid-tightly closed with the seal A liquid introduction needle in which a side hole is opened when the material is slid in the hub direction.
るとともに、環状リブとハブの距離を密封部材の長さよ
り長く形成してなる請求項１に記載の液体導入針。2. The liquid introduction needle according to claim 1, wherein an annular rib is provided at the hub-side end of the expanded diameter portion, and the distance between the annular rib and the hub is longer than the length of the sealing member.
の開口部に筒状容器と該筒状容器の開口から挿着される
プレフィルドシリンジとの間をシールするシール部材を
装着し、該開口から挿着されたプレフィルドシリンジを
長手方向にスライド可能かつ流体密に保持できるように
するとともに、他端の開口部にバイアルを固定するバイ
アル固定手段を設け、バイアルの少なくとも口部を収容
して保持できるようにしたガイドカプセルと、該ガイド
カプセルにハブより上側の刃先をプレフィルドシリンジ
挿着用開口側に向けかつ長手方向にスライド可能に収容
された請求項１に記載の液体導入針からなる乾燥製剤溶
解補助具。3. A cylindrical container having both ends opened, wherein a seal member for sealing between the cylindrical container and a prefilled syringe inserted through the opening of the cylindrical container is attached to one opening. The prefilled syringe inserted from the opening is slidable in the longitudinal direction and fluid-tightly held, and a vial fixing means for fixing the vial is provided at the opening at the other end to accommodate at least the mouth of the vial. A guide capsule that can be held by a guide capsule, and the guide capsule has a blade edge above a hub that is slidably housed in the prefilled syringe insertion opening side and is slidable in the longitudinal direction. Formulation dissolution aid.
けるとともに、ハブに当接し該環状リブによって係止さ
れるようにゴムキャップを装着し、該ゴムキャップでプ
レフィルドシリンジのチップをシールするようにしてな
る請求項３に記載の乾燥製剤溶解補助具。4. An annular rib is provided on the upper cutting edge side of the liquid introducing needle, and a rubber cap is attached so as to contact the hub and be locked by the annular rib, and the tip of the prefilled syringe is sealed with the rubber cap. The dry preparation dissolution aid according to claim 3, which is obtained as described above.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15910694A JP3456019B2 (en) | 1994-06-17 | 1994-06-17 | Liquid introduction needle and aid for dissolving dry preparation using the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP15910694A JP3456019B2 (en) | 1994-06-17 | 1994-06-17 | Liquid introduction needle and aid for dissolving dry preparation using the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH08710A true JPH08710A (en) | 1996-01-09 |
| JP3456019B2 JP3456019B2 (en) | 2003-10-14 |
Family
ID=15686381
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP15910694A Expired - Fee Related JP3456019B2 (en) | 1994-06-17 | 1994-06-17 | Liquid introduction needle and aid for dissolving dry preparation using the same |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3456019B2 (en) |
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| JP2002172151A (en) * | 2000-12-08 | 2002-06-18 | Nipro Corp | Liquid transfer filler |
| JP2004524914A (en) * | 2001-03-27 | 2004-08-19 | イーライ・リリー・アンド・カンパニー | Kit including side-ejection syringe needle for preparing drug in injection pen cartridge |
| KR100431704B1 (en) * | 2001-08-13 | 2004-05-17 | 주식회사 대웅 | Container plus syringe system |
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| JP2007117276A (en) * | 2005-10-26 | 2007-05-17 | Nipro Corp | Liquid transfer filler |
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|---|---|
| JP3456019B2 (en) | 2003-10-14 |
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