JP4324287B2 - Transfer needle - Google Patents

Transfer needle Download PDF

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Publication number
JP4324287B2
JP4324287B2 JP24290199A JP24290199A JP4324287B2 JP 4324287 B2 JP4324287 B2 JP 4324287B2 JP 24290199 A JP24290199 A JP 24290199A JP 24290199 A JP24290199 A JP 24290199A JP 4324287 B2 JP4324287 B2 JP 4324287B2
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Prior art keywords
container
drug
solution
needle
hollow
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JP2001061944A (en
Inventor
明彦 坂田
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Hosokawa Yoko KK
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Hosokawa Yoko KK
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Description

【0001】
【発明の属する技術分野】
本発明は、輸液などの調製において、薬剤と溶解液または他の薬液といった薬剤を溶解混合する際に、溶解液入り容器から薬剤入り容器へ溶解液が容易に移動できると共に、薬剤を溶解した溶解液が確実に溶解液入り容器に戻ることができるトランスファーニードルに関する。
【0002】
【従来の技術】
病院などの医療機関においては、バイアルなどの容器に入った制ガン剤、抗生物質、血液製剤などの粉末薬剤あるいは凍結乾燥薬剤などはそのまま輸液剤に混合して保存すると変質し易いもの、あるいは液状の薬剤として保存しておくと薬効が低下するというような薬剤は、これを使用直前に溶解して、例えば輸液剤として点滴治療に用いられている。
この薬剤の溶解のための薬剤の混合あるいは希釈には、希釈液容器あるいは薬液容器(以下「溶解液入り容器」という。)から注射器などにより希釈液または薬液(以下「溶解液」という。)を抜き取り、バイアルびんなどの薬剤容器(以下「薬剤入り容器」という。)に注入し、薬剤を溶解した後に同じく注射器などでこれを抜き取り、溶解液入り容器に再注入する方法が取られていた。
【0003】
この方法は煩雑であるばかりでなく衛生上問題があるため、これを改善するために中空部が平滑な、場合によっては補強のために先端に金属を用いたり、補強用のリブを設けた両頭中空針を用い、溶解液入り容器と薬剤入り容器とを直接接続し、溶解液を薬剤入り容器へ送り込み混合した後、そのまま薬剤を溶解した溶解液を戻す方法が採用された。またこの方法で更に衛生性、無菌性を高めた溶解液入り容器−両頭中空針一体型製品(以下「キット製品」という。)も上市されている。
両頭中空針を用いる混合方法は、薬剤入り容器と溶解液入り容器を接続した後、薬剤入り容器側を下に置き、溶解液を薬剤入り容器に注入し薬剤を溶解した後反転して、薬剤入り容器側の薬剤を溶解した溶解液を溶解液入り容器に戻す方法をとっている。
【0004】
このため、この操作を容易に行えるように選択的に空気あるいは溶解液または薬剤を溶解した溶解液を通すようにするため、両頭中空針の複数の中空部の断面形状を非対称にする、あるいは中空部の長さ(高さ)を不均一にする、溶解液入り容器と薬剤入り容器側の断面形状を不均一(同一中空部で両端の形状を異にする)にするなどの提案がなされていた。さらには撥水性や滑り性を向上させるため、シリコーンを塗布するなどの処置も採られていた。
しかし、空気と薬液の選択通過性は確実に発現するとは限らず、薬剤を溶解した溶解液が薬剤入り容器側に残ったり、また極端な場合には薬剤入り容器内に注入した高濃度溶液が溶解液入り容器に戻らないことが起き、そのために薬剤入り容器を押圧したり、打撃を加えて液の移動を促したり、薬液自身を廃棄せざるを得ない場合が起きることなどがあった。
【0005】
【発明が解決しようとする課題】
本発明は、上記の問題を解決するため、溶解液入り容器と薬剤入り容器を接続した時に、衛生的であって無菌的に、溶解液または薬剤を溶解した溶解液が容易にかつ確実に移動できるトランスファーニードルであって、製造が容易で、安価な中空針の開発を目的とする。
【0006】
【課題を解決するための手段】
本発明は、
[1] 複数の流体通路を平行に配された両頭中空針本体を具備するトランスファーニードルにおいて、少なくとも流体通路の中空部の一部に1または多数本の凸条または溝を設けたことを特徴とするトランスファーニードル、及び
[2] 薬剤が収納されたバイアルの口部に、複数の流体通路を平行に配された中空針本体を具備するトランスファーニードルにおいて、少なくとも流体通路の中空部の一部に1または多数本の凸条または溝を設けたトランスファーニードルが冠着されていることを特徴とする薬剤入り容器、
を開発することにより上記の目的を達成した。
【0007】
【発明の実施の形態】
以下図面を参照しながら本発明を具体的に説明する。
本発明におけるトランスファーニードル10の両頭中空針1は、その外観は図1に示すように従来の両頭中空針と類似の形状及びサイズであってよい。材質的にも従来のトランスファーニードルと同様に、硬質合成樹脂または金属であってよい。本発明のトランスファーニードル10の特徴的な部分はニードル1の流体通路2(針内部の中空部)の形状にあり、少なくともニードル1の一部、好ましくは刃先、より好ましくは両端の全長にわたり1本または多数本、好ましくは数本〜10数本の凸条6または溝7を中空部に設けた点にある。この凸条6または溝7のサイズは流体の通過に悪い影響を与えない範囲で自由に選択できる。
【0008】
この流体通路2は、ニードル1に2本設けるのが普通であるが、3本設けても使用できる。4本以上設けることは作業を複雑にするだけで流体の流通(液体の通過と反対方向への空気の通過)の効率を向上させることはない。ニードル1の刃先は溶解液入り容器及び薬剤入り容器のゴム栓などを貫通させるために鋭利な形状を有する。
このトランスファーニードル10は両頭中空針1を貫通するように設けた溶解液入り容器用栓3、薬剤入り容器用栓4及びその中間に両頭中空針1をそれら容器にセットする時の保持具となる中空針保持具5から構成されている。溶解液入り容器用栓3あるいは薬剤入り容器用栓4は通常ゴム栓が使用されている。また中空針保持具5は中空針が樹脂製の場合には両頭中空針と同一樹脂で一体に成形されていてよい。
【0009】
なお本発明のトランスファーニードルは、成形品表面に表面処理を行ったり、材料に各種の撥水剤や親水剤などの添加剤を配合した材料を用いてもよい。
この流体通路中空部に凸条または溝を形成する方法としては、両頭中空針を形成する素材に事前に凸条または溝を入れておく方法、金型内の形状(凸条または溝)を転写させる方法、従来方法による両頭中空針の中空針の刃先研磨において研磨材やその他の加工機により研磨加工をする方法などがある。
【0010】
一方、図4に示すようにトランスファーニードルを冠着した薬剤入り容器11側に使用するニードル13には、薬剤入り容器のゴム栓などを貫通する必要がないので、両頭中空針をそのまま使用してもよいが、薬剤入り容器11側には鋭利な刃先のない流体通路2が解放されていれば良い。なおその場合においても流体通路2の中空部の一部、好ましくは刃先(溶解液入り容器側)部または容器側端部に、より好ましくは刃先から他端まで貫通して1または多数本の凸条6または溝7を備えていることが必要である。この場合においても前記トランスファーニードルと同様に数本ないし10数本の凸条または溝を設けることが好ましい。 この薬剤入り容器11に薬剤を入れた後、上記のトランスファーニードル10を冠着し、それに、鋭利なニードルの刃先の保護と作業者の安全性確保並びに刃先などの細菌汚染などを防止するためにゴムキャップ15をかぶせ、更にこのゴムキャップの上にプラスチック製のプロテクターキャップ14をかぶせておくことが好ましい。
【0011】
使用に際しては、プロテクターキャップ14及びゴムキャップ15を取り、中空針保持具12を持って溶解液入り容器16のゴム栓などにトランスファーニードル13を差し込み、貫通させ、薬剤入り容器11を図5のように溶解液入り容器16の下に持って行き、溶解液を薬剤入り容器11に移動させる。
溶解液が注入された薬剤入り容器11を攪拌して薬剤を溶解させ、溶解液入り容器11及び薬剤入り容器16の位置を反転させ、薬剤を溶解した高濃度溶液を溶解液入り容器16に戻すことにより輸液剤が調製できる。必要ならこれを複数回繰り返すことにより薬剤の回収率を高めることができる。
本発明のトランスファーニードルが冠着されている薬剤入り容器は、薬剤入り容器側は病院などにおいてもまったく無菌的に密閉状態に使用可能であり、細菌などの汚染が起きる危険がまったくなく、また溶解液入り容器に刺通するトランスファーニードルも、使用までは完全にゴムキャップなどにより無菌的に保護されているなど、輸液剤の調製における衛生的安全性を極めて高く維持するものである。
【0012】
本発明のトランスファーニードルは、その理由までは完全に解明できなかったが、流体通路の中空部に刃先から他端まで凸条または溝を貫通させておくことにより、液の移動がスムーズに行われることにより溶解液入り容器と薬剤入り容器の間に溶解液が確実にかつ容易に移動できることが確認できた。
おそらく、本発明においてトランスファーニードルの流体通路の中空部の先端部にある微細な凸条または溝の凹凸が、液体の表面張力による液体の張力を破壊し、液体の塊状化を崩し空気の流入の妨害を排除するため、空気が一つの中空部を容易に通過し、これにより液体の流通を容易にしているのではないかと推定している。
【0013】
【実施例】
(実施例1〜11)
溶解液入り容器として大塚製薬(株)製の生理食塩液[TN:100ml]を用い、薬剤入り容器としては空の容器及び塩野義製薬(株)[バンコマイシン:1g]を用いた。
表1に示す原料を使用し、中空部形状及び中空部の内面形状が表1に示す両頭中空針(長径2.9mm、短径1.7mmの中空部が2本並列したもの)のトランスファーニードルを用いて溶解液入り容器から薬剤入り容器へ満注になるまで移動させた後、約0.5秒で反転させて薬剤入り容器を上にした状態で静置した時の液の戻り状況を測定した。この測定を100回繰り返し、液が戻った回数を%で表した。その結果を表1に示す。
【0014】
【表1】

Figure 0004324287
【0015】
(比較例1〜4)
比較のため、流体通路の中空部にまったく加工しないトランスファーニードルを作成し、これを実施例と同様に液の戻り状況を測定した。結果を表2に示す。
【0016】
【表2】
Figure 0004324287
【0017】
【発明の効果】
本発明のトランスファーニードルは、製造も容易でありコストもかからず、また流体通路中空部に凸条または溝を設ける簡単な加工により、溶解液入り容器から薬剤入り容器へ及び薬剤入り容器から溶解液入り容器への薬液等の注入が確実にかつ薬剤入り容器への薬液の残留の心配なしに行われ、輸液等の調製が容易となるものである。またトランスファーニードルを冠着した薬剤入り容器は、その衛生性、使用の容易、確実性から薬剤の溶解を無菌的に短時間でかつ薬剤の損失をもたらすことなく行えるなど極めて有効な効果を奏するものである。
【図面の簡単な説明】
【図1】本発明のトランスファーニードルの1例の外観図。
【図2】本発明の中空針に使用できる中空部断面形状の例。
【図3】本発明の流体通路に凸条または溝を設けた中空部断面図。
【図4】本発明のトランスファーニードルが冠着されている薬剤入り容器の断面図。
【図5】溶解液入り容器と薬剤入り容器をトランスファーニードルを用いて接続した状態を示した外観図。
【符号の説明】
1 両頭中空針
2 流体通路
3 溶解液入り容器用栓
4 薬剤入り容器用栓
5 中空針保持具
6 中空部凸条
7 中空部溝
10 トランスファーニードル
11 薬剤入り容器
12 中空針保持具
13 中空針
14 プロテクターキャップ
15 ゴムキャップ
16 溶解液入り容器[0001]
BACKGROUND OF THE INVENTION
In the preparation of an infusion solution or the like, the present invention enables the solution to be easily transferred from the solution-containing container to the drug-containing container when dissolving and mixing the drug and the drug such as a solution or other drug solution. The present invention relates to a transfer needle that can reliably return the liquid to the container containing the dissolved liquid.
[0002]
[Prior art]
In medical institutions such as hospitals, anticancer drugs, antibiotics, powdered drugs such as blood products or lyophilized drugs contained in containers such as vials can be easily altered or stored as liquid drugs. Drugs whose medicinal effects decrease when stored as such are dissolved immediately before use, and are used for infusion treatment as, for example, infusions.
For mixing or diluting the drug for dissolving the drug, a dilute solution or drug solution (hereinafter referred to as “dissolved solution”) is used from a diluent container or drug solution container (hereinafter referred to as “dissolved solution container”) with a syringe or the like. A method of extracting and injecting into a drug container such as a vial (hereinafter referred to as “drug-containing container”), dissolving the drug, and extracting the same with a syringe or the like and re-injecting it into a solution-containing container has been employed.
[0003]
This method is not only complicated, but also has a sanitary problem. To improve this, the hollow part is smooth. In some cases, metal is used at the tip for reinforcement, or both heads are provided with reinforcing ribs. A method was adopted in which a hollow needle was used to directly connect a solution-containing container and a drug-containing container, the solution was fed into the drug-containing container and mixed, and then the solution in which the drug was dissolved was returned as it was. In addition, a solution-containing container-double-ended hollow needle integrated product (hereinafter referred to as a “kit product”) that has further improved hygiene and sterility by this method is also on the market.
The mixing method using a double-ended hollow needle is to connect the container containing the drug and the container containing the solution, place the drug container side down, inject the solution into the container containing the drug, dissolve the drug, and then reverse the drug. A method is used in which a solution obtained by dissolving the medicine on the container side is returned to the container containing the solution.
[0004]
Therefore, in order to allow this operation to be easily performed, air or a solution or a solution in which a drug is dissolved is allowed to pass, so that the cross-sectional shapes of the hollow portions of the double-ended hollow needle are asymmetrical or hollow. Proposals have been made such as making the length (height) of the part non-uniform, and making the cross-sectional shapes of the solution-containing container and the drug-containing container side non-uniform (different shapes at both ends in the same hollow part). It was. Furthermore, in order to improve water repellency and slipperiness, measures such as applying silicone have been taken.
However, the selective passage between air and drug solution does not always occur, and the dissolved solution remains in the drug container or, in extreme cases, a high concentration solution injected into the drug container. In some cases, the container does not return to the solution-containing container. For this reason, the container containing the drug may be pressed, the movement of the liquid may be promoted by hitting, or the drug solution itself must be discarded.
[0005]
[Problems to be solved by the invention]
In order to solve the above problems, the present invention provides a hygienic and aseptic method for easily and surely transferring a dissolved solution or a dissolved solution of a drug when the container containing the dissolved solution and the container containing the drug are connected. An object of the present invention is to develop a transfer needle that is easy to manufacture and inexpensive.
[0006]
[Means for Solving the Problems]
The present invention
[1] A transfer needle comprising a double-ended hollow needle body in which a plurality of fluid passages are arranged in parallel, wherein one or a plurality of ridges or grooves are provided in at least a part of the hollow portion of the fluid passage. [2] In a transfer needle comprising a hollow needle body in which a plurality of fluid passages are arranged in parallel at the mouth portion of a vial containing a medicine, at least a part of the hollow portion of the fluid passage is 1 Or a container containing a medicine, wherein a transfer needle provided with a plurality of ridges or grooves is crowned,
The above objective was achieved by developing
[0007]
DETAILED DESCRIPTION OF THE INVENTION
The present invention will be specifically described below with reference to the drawings.
The double-ended hollow needle 1 of the transfer needle 10 according to the present invention may be similar in shape and size to a conventional double-ended hollow needle as shown in FIG. The material may be a hard synthetic resin or a metal as in the case of the conventional transfer needle. A characteristic portion of the transfer needle 10 of the present invention is in the shape of a fluid passage 2 (hollow portion inside the needle) of the needle 1, and at least a part of the needle 1, preferably a cutting edge, more preferably one over the entire length of both ends. Alternatively, a large number, preferably several to several dozen ridges 6 or grooves 7 are provided in the hollow portion. The size of the ridge 6 or the groove 7 can be freely selected within a range that does not adversely affect the passage of fluid.
[0008]
Normally, two fluid passages 2 are provided in the needle 1, but three fluid passages 2 can be used. Providing four or more only complicates the operation and does not improve the efficiency of fluid flow (air passage in the direction opposite to the liquid passage). The cutting edge of the needle 1 has a sharp shape so as to penetrate the solution-containing container and the rubber stopper of the drug-containing container.
The transfer needle 10 serves as a holder when the double-headed hollow needle 1 is set in the container and the container-filled container stopper 3, the drug-containing container stopper 4 provided so as to penetrate the double-headed hollow needle 1. It consists of a hollow needle holder 5. A rubber stopper is usually used as the stopper 3 for the container containing the solution or the stopper 4 for the medicine container. Further, when the hollow needle is made of resin, the hollow needle holder 5 may be integrally formed of the same resin as the double-ended hollow needle.
[0009]
In addition, the transfer needle of the present invention may use a material in which the surface of a molded product is subjected to surface treatment or a material in which additives such as various water repellents and hydrophilic agents are blended.
As a method for forming a ridge or groove in the hollow portion of the fluid passage, a method in which a ridge or groove is put in advance in a material for forming a double-ended hollow needle, a shape (projection or groove) in a mold is transferred. And a method of polishing with a polishing material or other processing machine in polishing of the edge of a hollow needle of a double-ended hollow needle by a conventional method.
[0010]
On the other hand, as shown in FIG. 4, the needle 13 used on the side of the drug-containing container 11 having the transfer needle attached thereto does not need to penetrate the rubber stopper of the drug-containing container. However, it is only necessary that the fluid passage 2 without a sharp blade edge is opened on the medicine container 11 side. Even in this case, one or a plurality of protrusions penetrate through a part of the hollow portion of the fluid passage 2, preferably the blade edge (dissolved liquid container side) portion or the container side end portion, more preferably from the blade edge to the other end. It is necessary to provide the strip 6 or the groove 7. Also in this case, it is preferable to provide several to ten or several ridges or grooves like the transfer needle. After putting the medicine in the medicine-containing container 11, the transfer needle 10 is crowned, and in order to protect the edge of the sharp needle, ensure the safety of the operator, and prevent bacterial contamination of the edge, etc. It is preferable to cover the rubber cap 15 and to cover the rubber cap with a plastic protector cap 14.
[0011]
In use, the protector cap 14 and the rubber cap 15 are removed, and the transfer needle 13 is inserted into the rubber stopper of the container 16 containing the solution with the hollow needle holder 12 and penetrated. To the bottom of the container 16 containing the solution, and the solution is moved to the container 11 containing the drug.
The drug-containing container 11 into which the dissolution liquid has been injected is stirred to dissolve the drug, the positions of the dissolution liquid-containing container 11 and the drug-containing container 16 are reversed, and the high-concentration solution in which the drug is dissolved is returned to the dissolution liquid-containing container 16. Thus, an infusion solution can be prepared. If necessary, the drug recovery rate can be increased by repeating this multiple times.
The container with the medicine to which the transfer needle of the present invention is attached can be used aseptically sealed in the hospital or the like at the side of the medicine container, there is no risk of contamination with bacteria, etc. The transfer needle that is pierced into the container containing the liquid is also aseptically protected by a rubber cap or the like until use, so that the hygienic safety in the preparation of the infusion is maintained extremely high.
[0012]
The transfer needle of the present invention could not be completely clarified until that reason, but the liquid can be smoothly moved by allowing the hollow portion of the fluid passage to penetrate the ridge or groove from the blade tip to the other end. As a result, it was confirmed that the solution could be reliably and easily moved between the solution-containing container and the drug-containing container.
Probably, in the present invention, the fine ridges or grooves on the tip of the hollow portion of the fluid passage of the transfer needle break the liquid tension due to the surface tension of the liquid, break up the liquid agglomeration and prevent the inflow of air. In order to eliminate the interference, it is assumed that air easily passes through one hollow part, thereby facilitating the flow of the liquid.
[0013]
【Example】
(Examples 1 to 11)
A physiological saline solution [TN: 100 ml] manufactured by Otsuka Pharmaceutical Co., Ltd. was used as the solution-containing container, and an empty container and Shionogi Pharmaceutical Co., Ltd. [vancomycin: 1 g] were used as the drug-containing containers.
Transfer needles using the raw materials shown in Table 1 and having a hollow portion and a hollow double-ended hollow needle whose inner surface shape is shown in Table 1 (two hollow portions having a major axis of 2.9 mm and a minor axis of 1.7 mm arranged in parallel) After moving the solution from the solution-containing container to the drug-containing container until it is fully filled, reverse the solution in about 0.5 seconds, and return the liquid when standing with the drug-containing container up. It was measured. This measurement was repeated 100 times, and the number of times the liquid returned was expressed in%. The results are shown in Table 1.
[0014]
[Table 1]
Figure 0004324287
[0015]
(Comparative Examples 1-4)
For comparison, a transfer needle that was not processed at all in the hollow portion of the fluid passage was prepared, and the return state of the liquid was measured in the same manner as in the example. The results are shown in Table 2.
[0016]
[Table 2]
Figure 0004324287
[0017]
【The invention's effect】
The transfer needle of the present invention is easy to manufacture and does not cost, and can be dissolved from a solution-containing container to a drug-containing container and from a drug-containing container by a simple process of providing a protrusion or groove in the fluid passage hollow portion. The injection of the chemical solution or the like into the liquid container is reliably performed without worrying about the remaining of the chemical solution in the drug container, and the preparation of the infusion solution or the like is facilitated. In addition, a drug-filled container with a transfer needle has extremely effective effects such as the ability to dissolve the drug aseptically in a short time without causing loss of the drug due to its hygiene, ease of use, and certainty. It is.
[Brief description of the drawings]
FIG. 1 is an external view of an example of a transfer needle of the present invention.
FIG. 2 shows an example of a cross-sectional shape of a hollow part that can be used in the hollow needle of the present invention.
FIG. 3 is a cross-sectional view of a hollow portion in which ridges or grooves are provided in the fluid passage of the present invention.
FIG. 4 is a cross-sectional view of a medicine container in which the transfer needle of the present invention is attached.
FIG. 5 is an external view showing a state in which a solution-containing container and a drug-containing container are connected using a transfer needle.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Double-headed hollow needle 2 Fluid path 3 Dissolving solution container stopper 4 Drug-containing container stopper 5 Hollow needle holder 6 Hollow part protrusion 7 Hollow part groove | channel 10 Transfer needle 11 Drug containing container 12 Hollow needle holder 13 Hollow needle 14 Protector cap 15 Rubber cap 16 Container with solution

Claims (2)

複数の流体通路を平行に配された両頭中空針本体を具備するトランスファーニードルにおいて、流体通路の中空部の内面全体に流体通路と平行な方向に多数本の凸条または溝を設けたことを特徴とするトランスファーニードル。In a transfer needle comprising a double-ended hollow needle body in which a plurality of fluid passages are arranged in parallel, a plurality of ridges or grooves are provided on the entire inner surface of the hollow portion of the fluid passage in a direction parallel to the fluid passage. Transfer needle. 薬剤が収納されたバイアルの口部に、複数の流体通路を平行に配された中空針本体を具備するトランスファーニードルにおいて、流体通路の中空部の内面全体に流体通路と平行な方向に多数本の凸条または溝を設けたトランスファーニードルが冠着されている薬剤入り容器。In a transfer needle comprising a hollow needle body in which a plurality of fluid passages are arranged in parallel at the mouth portion of a vial containing a medicine, the entire inner surface of the hollow portion of the fluid passage is arranged in a number parallel to the fluid passage . A drug-containing container in which a transfer needle provided with ridges or grooves is crowned.
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JP2016096846A (en) * 2014-11-18 2016-05-30 株式会社テクノクラーツ Hollow needle, equipment with needle, and medical equipment
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