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JP2004275443A - Liquid medicine preparation kit - Google Patents

Liquid medicine preparation kit Download PDF

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Publication number
JP2004275443A
JP2004275443A JP2003070943A JP2003070943A JP2004275443A JP 2004275443 A JP2004275443 A JP 2004275443A JP 2003070943 A JP2003070943 A JP 2003070943A JP 2003070943 A JP2003070943 A JP 2003070943A JP 2004275443 A JP2004275443 A JP 2004275443A
Authority
JP
Japan
Prior art keywords
vial
double
preparation kit
liquid medicine
slide cylinder
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
Application number
JP2003070943A
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Japanese (ja)
Other versions
JP4241108B2 (en
Inventor
Seiki Arikawa
清貴 有川
Minoru Shibata
稔 柴田
Yukihiko Sakaguchi
幸彦 坂口
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Bakelite Co Ltd
Original Assignee
Sumitomo Bakelite Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Sumitomo Bakelite Co Ltd filed Critical Sumitomo Bakelite Co Ltd
Priority to JP2003070943A priority Critical patent/JP4241108B2/en
Publication of JP2004275443A publication Critical patent/JP2004275443A/en
Application granted granted Critical
Publication of JP4241108B2 publication Critical patent/JP4241108B2/en
Anticipated expiration legal-status Critical
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Abstract

<P>PROBLEM TO BE SOLVED: To provide a liquid medicine preparation kit which does not waste preparations even when the puncturing sequence of a vial is mistaken. <P>SOLUTION: This liquid medicine preparation kit for preparing the liquid medicine using two vials having different shapes is constituted of a slide cylinder having two skirt parts having different shapes and a double-headed needle. A guide means of the double-headed needle and a pawl for locking the vial mouth are disposed in the slide cylinder. The length of at least one of the skirt parts is longer than the length in the axial direction of the double-headed needle. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

【0001】
【発明の属する技術分野】
本発明は薬液調製用キットに関する。更に詳しくは、本発明は容器内の乾燥薬剤を他の容器の溶解液と混合して液状薬剤を調製するのに適した薬液調製用キットに関する。
【0002】
【従来の技術】
病院等の医療機関においては、バイアル瓶等の薬剤容器に入った粉末薬剤あるいは凍結乾燥薬剤などの乾燥製剤を溶解して輸液として点滴注射に用いたり、生体組織接着剤の場合には組織に塗布して使用している。このような乾燥製剤を薬液に調製する操作は、薬剤の入った容器とその薬剤を溶解するための溶解液の入った容器とを両頭針あるいは連結管等の接続用具を用いて接続し、溶解液を薬剤の入った容器に移すことにより行なっている。
両頭針により溶解液が移動する原理は、凍結乾燥製剤と溶解液のバイアル瓶とを連通させると、凍結乾燥製剤のバイアル瓶内が陰圧状態であるため、圧力差が生じ溶解液が連通した流路を通って製剤側のバイアル瓶に移動するものである。両頭針の多くは製剤のバイアル瓶と溶解液のバイアルを同時に穿刺し使用する。
【0003】
ところが穿刺するタイミングがずれ、先に凍結乾燥製剤のバイアル瓶を穿刺してしまうと陰圧度が下がる為に連通後に溶解液を完全に製剤のバイアル瓶に移動することができないことがあった。またバイアル瓶を一つずつ穿刺する場合、人為的な間違いで先に製剤側にのみ穿刺した場合、瞬時に製剤側の陰圧状態が常圧に戻ってしまう為、溶解液が製剤側のバイアル瓶に全く移動しなくなり製剤を調製することができなくなる不具合があった。一般的にこのような種類の製剤は高価である為、病院等の医療機関に損害は大きい。
特許文献1報には、ハブの内面に小突起を設け下側の製剤から必ず穿刺できるキットが考案されている。しかしながら、バイアル瓶に専用のキャップを取り付けなければならず汎用性にかける。また、下側のバイアル瓶を装着し忘れた場合は、下方のねじ嵌合部分からバイアル瓶をねじ込まなければならず、コアリングの発生の危険性があった。
【0004】
【特許文献1】特開平8−173506号公報
【0005】
【発明が解決しようとする課題】
本発明は、上記の問題点を解決することを目的とするもので、バイアル瓶の穿刺順番を間違えても、製剤が無駄にならない両頭針を提供するものである。
【0006】
【課題を解決するための手段】
即ち本発明は、2つの形状の異なるバイアル瓶を使用して薬液を調整する薬液調製用キットにおいて、2つの形状の異なるスカート部を有するスライド筒及び両頭針から構成され、スライド筒に両頭針のガイド手段、及びバイアル瓶の口元を係り止めするツメが付設されており、少なくとも片方のスカート部の長さが両頭針の軸方向の長さより長いことを特徴とする薬液調製用キットである。
【0007】
【発明の実施の形態】
以下、図面を基に本発明について詳細に説明する。図1は本発明の一実施例となる薬液調製用キットである。図2はスライド筒(1)内に配置する両頭針部(2)を示す。
【0008】
(薬液充填用具の構造)
図1の構造を説明する。薬液調製用キットは、スライド筒(1)と両頭針部(2)からなる。スライド筒(1)には両頭針部(2)が軸方向に移動するガイド手段(3)が付設されている。またスライド筒(1)にはバイアル瓶の穿刺位置でバイアル瓶の口元を係り止めするツメ(12)が付設される。両頭針部(2)はスライド筒(1)内に配置される。
【0009】
(スライド筒)
スライド筒(1)は2つのスカート部(4、41、42)が付設される。2つのスカート(4、41、42)部は、セットするバイアル瓶の外周の形状より少し大きめの形状のであることが視覚的にバイアルをセットする位置が確認できるため好ましい。溶解液をセットするスカート部(4)には両頭針部(2)がスライドするガイド手段(3)を付設する。ガイド手段(3)はスカート部(4)に付設されたスリットでも溝でもよい。スリットの端部には両頭針部(2)が簡単に脱落することを防止する突起が付設されることが望ましい。
2つのスカート部(41、42)は形状が異なる。一般的なバイアル瓶は円筒状である為、異なる2つの直径を有するスカート部(41、42)を付設することが望ましい。先に穿刺する方のスカート部(41)は、後に穿刺する方のスカート部(42)より小さな直径とすることで、穿刺順番の間違いを防止することができる。
スカート部(4)の一部はテーパー形状とした方がコンパクトな大きさになる他、バイアル瓶にスカート部(4)が密接するためツメ(12)を付設しやすくなり好ましい。
【0010】
バイアル瓶の穿刺位置でバイアル瓶の口元を係り止めするツメ(12)が付設される。ツメ(12)はスカート部(4)に付設することがスライド筒(1)をコンパクトにできるため望ましい。ツメ(12)は、スライド筒(1)の仕切り板(5)から設置しても良い。スライド筒(1)には仕切り板(5)を付設した方が両頭針の位置がしっかりと固定される為望ましい。仕切り板(5)の中央は針部(6)が通過できるように穴が付設されていることが好ましい。
後に穿刺する方のスカート部(4)の長さは、両頭針の針の長さより長い方が使用者の手や指を誤穿刺せず、清潔さを保つために望ましい。先に穿刺する側のスカート部(4)は両頭針部(2)の軸方向の長さより長い方が好ましい。
バイアル瓶のゴム栓を穿刺する場合に針先がゴム栓の中央に位置するようにスカート部(4)を通して狙いをつけるためスライド筒(1)は透明な素材であることが好ましい。スライド筒(1)は合成樹脂等により射出成形機などから作製される方が安価で好ましく、ポリカーボネート樹脂、ABS樹脂、ポリ塩化ビニル樹脂、ポリスチレン樹脂、ポリウレタン樹脂等から作製されることが望ましい。
【0011】
(両頭針部)
両頭針部(2)は、少なくとも2つの針部(6)と針部(6)間を連通する流路(9)、スライド筒(1)内をスライドするスライド部(7)から構成され、バイアル内部と外部を連通する通気路(10)や通気路(10)途中に付設されたフィルター部、通気路(10)端に付設されたシリンジ等の吸引手段が着脱可能なポート部(8)を含む。
針部(7)は、直径5mm以下で長さは50mm以下であることがバイアル瓶のゴム栓の穿刺抵抗が小さくなり好ましい。
針部(6)には上下2つのバイアル瓶を連通する流路(9)が付設される。直径は0.5〜3mmであることが成形作業が行いやすく好ましい。
スライド部(7)は、スライド筒(1)内を軸方向に沿って移動できるようにする方が、穿刺抵抗が小さくなる他、針部(6)が折れてしまう危険が少なくなり好ましい。更に好ましくはスライド筒(1)の内側の少なくとも一部分の形状と一致させることが好ましい。また、中心軸からずれないように軸に対して平行な面をスライド筒(1)の形状の一部に付設することが好ましい。スライド部(7)にはスカート(4)部のスリットや溝に対応する突起等が付設される。ポート部(8)を付設する場合はポート部(8)をスリットに嵌める構造として突起の代用とすることが好ましい。
スライド部(7)にポート部(8)を付設すると、調製操作後直ぐに内容物をシリンジ等に充填できるため好ましい。ポート部(8)を付設しない場合はバイアル瓶を薬液調製用キットから取り外し、再度針を用いてシリンジ等に吸引する必要がある。コアリング等の発生により異物を吸引する可能性があり好ましくない。
【0012】
解けにくい製剤の場合には外部に連通する通気路(10)を付設することが好ましい。製剤が解けにくい場合は溶解液を注入後に良く振り混ぜる必要があるためどうしても泡立ってしまう。凍結乾燥された製剤の場合は常圧に戻すことにより発生した泡が消失させることが可能で内容物を収率良く吸引できる。この通気路(10)中には常圧に戻す際にバイアル瓶外の異物が容易に入らぬようにフィルターを付設することが好ましく、除菌レベルのフィルター(約孔径0.3μm以下)を設置することが更に好ましい。通気路(10)を付設する場合は溶解操作中にバイアル瓶内が常圧に戻らないようにキャップ(11)が付設される。
【0013】
次に実際の操作方法に基づき本発明について説明する。
1.溶解液のバイアル瓶を穿刺する(図3)。バイアル瓶の口元はスライド筒(1)のツメ(12)に固定される。もしも誤って凍結乾燥製剤の入ったバイアル瓶を穿刺しようとした場合、図4に示すように、Aの方向から穿刺しようとするとスカート部(41)がバイアル瓶の肩に引っかかり穿刺することができず、Bの方向から溶解液のバイアル瓶を穿刺しようとすると両頭針部(2)がスライド筒(1)内で固定されていないため、穿刺することができずに両頭針部(2)がスライドする。ここで使用者は間違いに気づき溶解液のバイアルを手にする。
2.凍結乾燥製剤の入ったバイアル瓶を穿刺し、溶解するまで振り混ぜる(図5)。
3.ポート部(8)から吸引手段により内容液を吸引する。
【0014】
【発明の効果】
本発明による薬液調製キットは、バイアル瓶の穿刺順番を間違えても、製剤が無駄になることはない。
【図面の簡単な説明】
【図1】本発明の一実施例となる薬液調製用キットの正面図及び一部を切り欠いた側面図を示す。
【図2】本発明の両頭針部の正面図及び断面図を示す
【図3】本発明の一実施例となる薬液調製用キットで溶解液のバイアル瓶を穿刺した状態を示す。
【図4】本発明の一実施例となる薬液調製用キットで使用者が誤って凍結乾燥製剤のバイアル瓶を穿刺しようとした状態を示す。
【図5】本発明の一実施例となる薬液調製用キットで溶解液のバイアル瓶、及び凍結乾燥製剤のバイアル瓶を穿刺した状態を示す。
【符号の説明】
1 スライド筒
2 両頭針部
3 ガイド手段
4 スカート部
41 溶解液のバイアル瓶側のスカート部
42 凍結乾燥製剤のバイアル瓶側のスカート部
5 仕切り板
6 針部
7 スライド部
8 ポート部
9 流路
10 通気路
11 キャップ
12 ツメ
[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a drug solution preparation kit. More specifically, the present invention relates to a drug solution preparation kit suitable for preparing a liquid drug by mixing a dry drug in a container with a solution in another container.
[0002]
[Prior art]
In hospitals and other medical institutions, dry preparations such as powdered or lyophilized drugs in drug containers such as vials are dissolved and used for infusion as infusions, or applied to tissues in the case of biological tissue adhesives. And use it. The operation of preparing such a dry preparation into a drug solution is to connect a container containing a drug and a container containing a dissolving solution for dissolving the drug by using a double-ended needle or a connection tool such as a connecting pipe, and dissolving the drug. This is done by transferring the liquid to a container containing the drug.
The principle that the lysate is moved by the double-ended needle is that when the lyophilized formulation and the vial of the lysate are communicated with each other, a pressure difference occurs due to the negative pressure inside the vial of the lyophilized formulation, and the lysate communicates It moves to the vial on the formulation side through the flow path. Many double-ended needles are used by simultaneously piercing the vial of the preparation and the vial of the lysis solution.
[0003]
However, the timing of puncturing was shifted, and if the vial of the lyophilized preparation was punctured first, the negative pressure was lowered, so that the solution could not be completely transferred to the vial of the preparation after communication. In addition, when piercing the vial one by one, if puncturing only the product first due to human error, the negative pressure state on the product side immediately returns to normal pressure. There was a problem that it could not be moved to the bottle at all and the preparation could not be prepared. In general, these types of preparations are expensive, and cause serious damage to medical institutions such as hospitals.
Patent Literature 1 discloses a kit in which a small protrusion is provided on the inner surface of a hub and can always be punctured from the lower preparation. However, a special cap must be attached to the vial, which increases versatility. In addition, if the user forgets to attach the lower vial, the vial must be screwed in from the lower screw fitting portion, and there is a risk of coring.
[0004]
[Patent Document 1] Japanese Patent Application Laid-Open No. 8-173506
[Problems to be solved by the invention]
An object of the present invention is to solve the above-mentioned problems, and an object of the present invention is to provide a double-ended needle in which the preparation is not wasted even if the puncturing order of the vial is incorrect.
[0006]
[Means for Solving the Problems]
That is, the present invention provides a drug solution preparation kit for adjusting a drug solution using two differently shaped vials, a slide tube having two differently shaped skirt portions and a double-ended needle, wherein the slide tube has a double-ended needle. A kit for preparing a drug solution, comprising a guide means and a claw for engaging a mouth of a vial, wherein at least one skirt portion is longer than an axial length of the double-ended needle.
[0007]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, the present invention will be described in detail with reference to the drawings. FIG. 1 shows a drug solution preparation kit according to one embodiment of the present invention. FIG. 2 shows a double-ended needle part (2) arranged in the slide cylinder (1).
[0008]
(Structure of chemical filling tool)
The structure of FIG. 1 will be described. The drug solution preparation kit includes a slide cylinder (1) and a double-ended needle part (2). The slide cylinder (1) is provided with guide means (3) for moving the double-ended needle portion (2) in the axial direction. Further, the slide cylinder (1) is provided with a claw (12) for locking the mouth of the vial at the puncturing position of the vial. The double-ended needle part (2) is arranged in the slide cylinder (1).
[0009]
(Slide tube)
The slide cylinder (1) is provided with two skirt portions (4, 41, 42). It is preferable that the two skirts (4, 41, 42) have a slightly larger shape than the outer shape of the vial to be set, since the position at which the vial is set can be visually confirmed. A guide means (3) on which the double-ended needle (2) slides is attached to the skirt (4) for setting the solution. The guide means (3) may be a slit or a groove provided on the skirt (4). It is preferable that a protrusion for preventing the double-ended needle portion (2) from easily falling off is provided at the end of the slit.
The two skirt portions (41, 42) have different shapes. Since a general vial is cylindrical, it is desirable to provide skirts (41, 42) having two different diameters. The skirt portion (41) to be punctured first has a diameter smaller than that of the skirt portion (42) to be punctured later, thereby preventing the puncturing order from being incorrect.
It is preferable that a part of the skirt portion (4) be tapered to make the size compact and that the skirt portion (4) comes into close contact with the vial so that the claw (12) can be easily attached.
[0010]
A claw (12) is provided to stop the mouth of the vial at the puncturing position of the vial. It is desirable that the claw (12) be attached to the skirt portion (4) because the slide cylinder (1) can be made compact. The claw (12) may be installed from the partition plate (5) of the slide cylinder (1). A partition plate (5) is preferably attached to the slide cylinder (1) because the position of the double-ended needle is firmly fixed. The center of the partition plate (5) is preferably provided with a hole so that the needle portion (6) can pass through.
The length of the skirt portion (4) to be later punctured is desirably longer than the length of the double-ended needle so as not to erroneously puncture the user's hand or finger and to maintain cleanliness. The skirt portion (4) on the side to be punctured first is preferably longer than the axial length of the double-ended needle portion (2).
The slide cylinder (1) is preferably made of a transparent material so that when the rubber stopper of the vial is punctured, an aim is made through the skirt (4) so that the needle point is located at the center of the rubber stopper. The slide cylinder (1) is preferably made of synthetic resin or the like from an injection molding machine or the like at a low cost, and is preferably made of polycarbonate resin, ABS resin, polyvinyl chloride resin, polystyrene resin, polyurethane resin, or the like.
[0011]
(Double-ended needle)
The double-ended needle part (2) is composed of at least two needle parts (6), a flow path (9) communicating between the needle parts (6), and a slide part (7) that slides inside the slide cylinder (1), A port portion (8) to which a suction means such as a ventilation passage (10) communicating between the inside and the outside of the vial, a filter portion provided in the middle of the ventilation passage (10), and a syringe provided at the end of the ventilation passage (10) is detachable. including.
It is preferable that the needle portion (7) has a diameter of 5 mm or less and a length of 50 mm or less since the puncture resistance of the rubber stopper of the vial becomes small.
The needle (6) is provided with a flow path (9) for communicating the upper and lower vials. It is preferable that the diameter is 0.5 to 3 mm because the molding operation can be easily performed.
It is preferable that the slide portion (7) can be moved in the slide cylinder (1) in the axial direction, because the puncture resistance is reduced and the risk that the needle portion (6) is broken is reduced. More preferably, it is preferable to match the shape of at least a part of the inside of the slide cylinder (1). In addition, it is preferable that a surface parallel to the axis is attached to a part of the shape of the slide cylinder (1) so as not to be shifted from the center axis. The slide portion (7) is provided with projections and the like corresponding to the slits and grooves of the skirt (4). When the port portion (8) is additionally provided, it is preferable that the port portion (8) is fitted into the slit so as to substitute for the projection.
It is preferable to attach the port portion (8) to the slide portion (7) because the contents can be filled in a syringe or the like immediately after the preparation operation. When the port (8) is not provided, it is necessary to remove the vial from the drug solution preparation kit and aspirate it again into a syringe or the like using a needle. Foreign matter may be sucked by the occurrence of coring or the like, which is not preferable.
[0012]
In the case of a formulation which is difficult to be dissolved, it is preferable to provide an air passage (10) communicating with the outside. Inevitably bubbled for if the formulation is not easily solved needs shaken well after injection of solution. In the case of a freeze-dried preparation, foams generated by returning the pressure to normal pressure can be eliminated, and the contents can be sucked in a high yield. It is preferable to provide a filter in the ventilation path (10) so that foreign matter outside the vial does not easily enter when returning to normal pressure, and a filter of a sterilization level (about 0.3 μm or less in diameter) is provided. More preferably, When the ventilation path (10) is provided, a cap (11) is provided so that the inside of the vial does not return to normal pressure during the dissolving operation.
[0013]
Next, the present invention will be described based on an actual operation method.
1. Puncture the lysate vial (FIG. 3). The mouth of the vial is fixed to the claws (12) of the slide cylinder (1). If the user tries to puncture the vial containing the freeze-dried preparation by mistake, as shown in FIG. When trying to puncture the vial of the lysis solution from the direction B, the double-ended needle (2) is not fixed in the slide cylinder (1), so the double-ended needle (2) cannot be punctured. Slide. Here, the user notices the mistake and gets a vial of the lysis solution.
2. Puncture the vial containing the lyophilized preparation and shake until dissolved (FIG. 5).
3. The contents liquid is sucked from the port (8) by the suction means.
[0014]
【The invention's effect】
In the drug solution preparation kit according to the present invention, even if the puncturing order of the vial is incorrect, the preparation is not wasted.
[Brief description of the drawings]
FIG. 1 shows a front view and a partially cutaway side view of a drug solution preparation kit according to one embodiment of the present invention.
FIG. 2 shows a front view and a cross-sectional view of a double-ended needle part of the present invention. FIG. 3 shows a state in which a vial of a lysis solution is punctured with a drug solution preparation kit according to one embodiment of the present invention.
FIG. 4 shows a state in which a user erroneously tries to puncture a vial of a lyophilized preparation with the drug solution preparation kit according to one embodiment of the present invention.
FIG. 5 shows a state in which a vial of a lysate and a vial of a freeze-dried preparation are punctured with a drug solution preparation kit according to one embodiment of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Slide cylinder 2 Double-ended needle part 3 Guide means 4 Skirt part 41 Skirt part of vial side of lysate 42 Skirt part of vial side of freeze-dried preparation 5 Partition plate 6 Needle part 7 Slide part 8 Port part 9 Flow path 10 Ventilation path 11 Cap 12 Claw

Claims (1)

2つの形状の異なるバイアル瓶を使用して薬液を調整する薬液調製用キットにおいて、2つの形状の異なるスカート部を有するスライド筒及び両頭針から構成され、スライド筒に両頭針のガイド手段、及びバイアル瓶の口元を係り止めするツメが付設されており、少なくとも片方のスカート部の長さが両頭針の軸方向の長さより長いことを特徴とする薬液調製用キット。In a drug solution preparation kit for adjusting a drug solution using vials having two different shapes, a slide tube having a skirt portion having two different shapes and a double-ended needle are provided. A drug solution preparation kit, further comprising a claw for engaging a mouth of a bottle, wherein at least one skirt portion is longer than an axial length of the double-ended needle.
JP2003070943A 2003-03-14 2003-03-14 Chemical solution preparation kit Expired - Fee Related JP4241108B2 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102716521A (en) * 2012-04-06 2012-10-10 重庆莱美药业股份有限公司 All-sealing screw-in preassembly-type medicine feeder
WO2013120342A1 (en) * 2012-02-13 2013-08-22 重庆莱美药业股份有限公司 Doser having two needles
US9839581B2 (en) 2012-04-06 2017-12-12 Chongqing Lummy Pharmaceutical Co., Ltd. Preassembled medicine mixer

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013120342A1 (en) * 2012-02-13 2013-08-22 重庆莱美药业股份有限公司 Doser having two needles
CN102716521A (en) * 2012-04-06 2012-10-10 重庆莱美药业股份有限公司 All-sealing screw-in preassembly-type medicine feeder
US9839581B2 (en) 2012-04-06 2017-12-12 Chongqing Lummy Pharmaceutical Co., Ltd. Preassembled medicine mixer

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