JP2004321826A - Cap and pre-filled drug solution container - Google Patents

Cap and pre-filled drug solution container Download PDF

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JP2004321826A
JP2004321826A JP2004209195A JP2004209195A JP2004321826A JP 2004321826 A JP2004321826 A JP 2004321826A JP 2004209195 A JP2004209195 A JP 2004209195A JP 2004209195 A JP2004209195 A JP 2004209195A JP 2004321826 A JP2004321826 A JP 2004321826A
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cap
nozzle
liquid
hole
base end
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JP3949124B2 (en
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Shigeru Suzuki
鈴木  茂
Masaaki Kasai
正秋 笠井
Masashi Takemoto
昌史 竹本
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Terumo Corp
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Terumo Corp
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3103Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104Caps for syringes without needle

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

<P>PROBLEM TO BE SOLVED: To provide a cap whose nozzle part can be perfectly sterilized, when being sterilized easily and securely dried after sterilization, and is hardly contaminated by microorganisms during use, and a pre-filled drug solution container to be equipped therewith. <P>SOLUTION: A pre-filled syringe comprises a syringe body having a nozle arranged on the distal side end of a columular body, and a cap for covering on the nozzle. The cap comprises a cap main body and a rubber film. A through-hole is formed on the central part of the distal end of the cap main body. The through-hole comprises a large diameter part 311 which is positioned to the distal end side and has a constant inner diameter, a small diameter part 313 which is positioned to the proximal end side and has an inner diameter smaller than that of the large diameter part 311, and a taper part 312 which is positioned between the large diameter part 311 and the small diameter part 313 and has a inner diameter made gradually smaller toward the proximal end. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

本発明は、予め薬液が充填された容器(いわゆるプレフィルドシリンジ)およびそれに用いられるキャップに関する。   The present invention relates to a container (a so-called pre-filled syringe) filled with a drug solution in advance and a cap used for the container.

患者に輸液を投与するのに先立って、輸液容器内に充填された輸液にビタミン剤、ミネラル類、抗生物質のような様々な薬剤を必要に応じて配合することが行われている。   Prior to administering an infusion to a patient, various drugs such as vitamins, minerals, and antibiotics are blended into the infusion filled in the infusion container as necessary.

また、救急医療の現場では注射器によって自律神経作用薬、昇圧薬などの複数併用および大量投与が行われている。   Further, in the field of emergency medical care, a plurality of autonomic nervous drugs, vasopressors and the like are used in combination and in large amounts by syringes.

このような薬剤の配合や投与は、バイアル瓶から注射器によって薬液を吸引し、次いで輸液容器あるいは直接血管に薬液を注入することによって行われている。しかしながら、このような薬剤の配合及び投与は操作が煩雑であり、配合に要する時間、投与に要する時間が長くかかるという欠点がある。さらに上記の操作は、大気と接触した状態で行われるため、細菌汚染や異物混入のおそれがあった。   The compounding or administration of such a drug is performed by sucking a drug solution from a vial via a syringe and then injecting the drug solution into an infusion container or directly into a blood vessel. However, the compounding and administration of such a drug has the disadvantage that the operation is complicated, and the time required for compounding and the time required for administration are long. Furthermore, since the above operation is performed in a state of contact with the atmosphere, there is a risk of bacterial contamination and foreign matter contamination.

これらの問題を解決するものとして注射器に予め薬液を充填し先端のノズルにゴムキャップをしたいわゆるプレフィルドシリンジが提案された。しかし、従来のプレフィルドシリンジは、シリンジノズルがキャップによって密着する形で被せられている。従って、高圧蒸気滅菌時、ノズルとキャップの間に蒸気が侵入せずこの部分の滅菌が行えなかった。この問題を解決するために蒸気が侵入するようノズルとキャップの間に隙間を設けたものが提案されている。   As a solution to these problems, a so-called pre-filled syringe has been proposed in which a syringe is pre-filled with a drug solution and a nozzle at the tip is capped with a rubber cap. However, the conventional prefilled syringe is covered in such a manner that the syringe nozzle is in close contact with the cap. Therefore, at the time of high-pressure steam sterilization, steam did not enter between the nozzle and the cap, and this portion could not be sterilized. In order to solve this problem, a device has been proposed in which a gap is provided between the nozzle and the cap so that steam can enter.

しかし、蒸気が侵入するようノズルとキャップの間に隙間を設けた場合であっても、滅菌工程終了後に乾燥が容易に行われず、残った水分がカビ等の発生源になる可能性があるなどの問題があった。   However, even if a gap is provided between the nozzle and the cap to allow steam to enter, drying is not easily performed after the sterilization step, and the remaining moisture may become a source of mold and the like. There was a problem.

また、包材を開封し取り出すと、器具は外部雰囲気に晒されるので、表面に露出した部分などは特に細菌に汚染され易くなる。   In addition, when the packaging material is opened and taken out, the device is exposed to the external atmosphere, so that the portion exposed on the surface is easily contaminated with bacteria.

そこで、本発明の目的は、滅菌時ノズル部分が完全に滅菌でき、また滅菌後の乾燥も容易かつ確実に行え、使用時においても細菌に汚染され難いキャップおよびこれを備えた既充填薬液容器を提供することにある。   Therefore, an object of the present invention is to provide a cap that can completely sterilize the nozzle portion during sterilization, can easily and reliably dry after sterilization, and is less likely to be contaminated by bacteria even during use, and a pre-filled chemical liquid container provided with the same. To provide.

このような目的は、下記(1)〜(8)の本発明により達成される。
(1) 薬液を吐出するノズルを備え薬液が充填された薬液容器の前記ノズルに被冠され、前記ノズルの先端開口を液密に封止するキャップであって、
先端中央部に貫通孔を有し基端が開放端となっており、かつ基端側において隙間を有した状態で前記ノズルと係止する係止部を有するキャップ本体と、
前記貫通孔の基端開口を塞ぐように前記キャップ本体内に設置され、前記係止部が前記ノズルに係止した状態で前記ノズルの先端開口を液密に封止する封止部材とを備え、
前記貫通孔は、その内径が基端方向に向かって漸減するようなテーパが施されたテーパ部を有することを特徴とするキャップ。
Such an object is achieved by the present invention described in the following (1) to (8).
(1) A cap which is provided with a nozzle for discharging a chemical solution, is covered by the nozzle of a chemical solution container filled with the chemical solution, and seals a tip end opening of the nozzle in a liquid-tight manner,
A cap body having a through hole in the center of the distal end, the base end being an open end, and having a locking portion that locks with the nozzle with a gap on the base end side;
A sealing member that is installed in the cap body so as to close a base end opening of the through hole, and seals a tip end opening of the nozzle in a liquid-tight manner with the locking portion locked to the nozzle. ,
The cap, wherein the through hole has a tapered portion whose inner diameter gradually decreases toward a base end.

(2) 薬液を吐出するノズルを備え薬液が充填された薬液容器の前記ノズルに被冠され、前記ノズルの先端開口を液密に封止するキャップであって、
先端中央部に貫通孔を有し基端が開放端となっており、かつ基端側において隙間を有した状態で前記ノズルと係止する係止部を有するキャップ本体と、
前記貫通孔の基端開口を塞ぐように前記キャップ本体内に設置され、前記係止部が前記ノズルに係止した状態で前記ノズルの先端開口を液密に封止する封止部材とを備え、
前記貫通孔は、先端側に位置し、内径が一定の大径部、基端側に位置し、前記大径部の内径より小さい内径の小径部、および前記大径部と前記小径部との間に位置し、内径が基端方向に向かって漸減するようなテーパが施されたテーパ部で構成されていることを特徴とするキャップ。
(2) A cap which is provided with a nozzle for discharging a chemical solution, is covered by the nozzle of the chemical solution container filled with the chemical solution, and seals a tip end opening of the nozzle in a liquid-tight manner,
A cap body having a through hole in the center of the distal end, the base end being an open end, and having a locking portion that locks with the nozzle with a gap on the base end side;
A sealing member that is installed in the cap body so as to close a base end opening of the through hole, and seals a tip end opening of the nozzle in a liquid-tight manner with the locking portion locked to the nozzle. ,
The through hole is located at the distal end, the large diameter portion having a constant inner diameter, located at the base end side, the small diameter portion having an inner diameter smaller than the inner diameter of the large diameter portion, and the large diameter portion and the small diameter portion A cap which is located between and has a tapered portion whose inner diameter gradually decreases in a proximal direction.

(3) 前記キャップ本体の先端面に、前記貫通孔の先端開口を囲むように、リング状のリブが突出形成されている上記(1)または(2)に記載のキャップ。   (3) The cap according to the above (1) or (2), wherein a ring-shaped rib is formed so as to protrude from a distal end surface of the cap body so as to surround a distal end opening of the through hole.

(4) 前記キャップ本体の外周面に、軸方向に伸びる溝が形成されている上記(1)ないし(3)のいずれかに記載のキャップ。   (4) The cap according to any one of (1) to (3), wherein a groove extending in an axial direction is formed on an outer peripheral surface of the cap body.

(5) 前記封止部材は、中空針を刺通可能な再シール性ゴム部材で構成されている上記(1)ないし(4)のいずれかに記載のキャップ。   (5) The cap according to any one of (1) to (4), wherein the sealing member is formed of a re-sealable rubber member that can penetrate a hollow needle.

(6) 前記テーパ部の内面は、前記封止部材に刺通される中空針を案内する機能を有する上記(1)ないし(5)のいずれかに記載のキャップ。   (6) The cap according to any one of (1) to (5), wherein the inner surface of the tapered portion has a function of guiding a hollow needle penetrated by the sealing member.

(7) 前記キャップ本体および前記封止部材は、透明性を有するものである上記(1)ないし(6)のいずれかに記載のキャップ。   (7) The cap according to any one of (1) to (6) above, wherein the cap body and the sealing member have transparency.

(8) 内壁によって規定される空間に薬液を充填した薬液収納部と、該薬液収納部に収納された薬液を吐出するための開口を有するノズルと、薬液を吐出させる薬液吐出機構とを有する容器本体と、
上記(1)ないし(7)のいずれかに記載のキャップとを備えてなることを特徴とする既充填薬液容器。
(8) A container having a liquid medicine storage section in which a space defined by an inner wall is filled with a liquid medicine, a nozzle having an opening for discharging the liquid medicine stored in the liquid medicine storage section, and a liquid medicine discharge mechanism for discharging the liquid medicine. Body and
A pre-filled chemical liquid container comprising the cap according to any one of the above (1) to (7).

本発明によれば、ノズルとキャップの間に空隙を有する構造であるので、ノズルの注射針装着部の無菌性が注射針の装着直前まで維持される。その結果、ノズルとキャップ間の水分を容易に除去でき、この部分のくもりが防止できるとともに、残存した水分によるカビや細菌の発生が防止される。   ADVANTAGE OF THE INVENTION According to this invention, since it is a structure which has a space | gap between a nozzle and a cap, the sterility of the injection needle installation part of a nozzle is maintained until just before mounting of an injection needle. As a result, the water between the nozzle and the cap can be easily removed, clouding of this portion can be prevented, and the generation of mold and bacteria due to the remaining water can be prevented.

また、本発明は、針管に再シールチップを組み合わせた両頭針を有するホルダーと組み合わせることにより、同種のキャップを有する種類の違う薬剤の充填された既充填薬液容器を連続的に混注あるいは投与することができる。   In addition, the present invention combines a holder having a double-ended needle in which a reseal tip is combined with a needle tube to continuously co-inject or administer a pre-filled drug solution container having a different type of drug having the same type of cap. Can be.

また、本発明は、キャップの先端中央部に貫通孔を有し、該貫通孔の基端を封止部材(再シール部材)で封止するように構成されているため、ホルダーの両頭針(中空針)で穿刺される封止部材は、キャップの先端面より所定距離基端側に引っ込んだ位置に存在することとなり、そのため、滅菌後ホルダー装着直前までの間、先端部の穿刺部分の無菌性が保たれる。   In addition, the present invention has a through hole at the center of the distal end of the cap, and is configured to seal the base end of the through hole with a sealing member (resealing member). The sealing member punctured by the hollow needle) is located at a position retracted from the distal end surface of the cap by a predetermined distance to the proximal end side. Sex is maintained.

そして、貫通孔がテーパ部を有する形状であるため、封止部材に中空針を穿刺する際、テーパ部のテーパ面により中空針を適正に案内、誘導することができる。   And since a through-hole is a shape which has a taper part, when piercing a hollow needle to a sealing member, a hollow needle can be guided and guided appropriately by the taper surface of a taper part.

まず、本発明の既充填薬液容器の実施形態について説明すると、本発明の既充填薬液容器は、薬液吐出機構によって吐出される薬液を収納した容器本体のノズルを封止するキャップをノズルを滅菌可能なようにノズルとの間に蒸気が通過可能な隙間を持たせたものにおいて生ずることのある、キャップ内表面のくもりやキャップとノズルの間に残存した水分による黴の発生のおそれをなくすことができる。すなわち、キャップの閉塞端側に容器本体内を液密に封止する封止部を有するとともにキャップ開放端側に隙間を有した状態でノズルと係止する係止部を有し、かつキャップ内部の閉塞端と開放端との中間部にはキャップ内面とノズル外表面とで形成される空間部を有するよう構成されており、滅菌後、キャップ内面とノズル外表面間に残存した水分が容易に蒸散することができる。その結果、キャップ部分のくもりや黴の発生のおそれが除去された。   First, a description will be given of an embodiment of a pre-filled drug solution container of the present invention. The pre-filled drug solution container of the present invention can sterilize a cap for sealing a nozzle of a container body containing a drug solution discharged by a drug solution discharge mechanism. In order to eliminate the possibility of clouding of the inner surface of the cap and the possibility of mold generation due to moisture remaining between the cap and the nozzle, which may occur in the case where there is a gap through which steam can pass between the nozzle and the nozzle. it can. That is, the cap has a sealing portion on the closed end side for sealing the inside of the container in a liquid-tight manner, and has a locking portion for locking with the nozzle with a gap on the open end side of the cap, and the inside of the cap. The intermediate portion between the closed end and the open end of the cap is configured to have a space formed by the inner surface of the cap and the outer surface of the nozzle, so that moisture remaining between the inner surface of the cap and the outer surface of the nozzle after sterilization can be easily removed. Can evaporate. As a result, the possibility of clouding and mold generation at the cap portion was eliminated.

薬液収納部は内部空間に用途に応じてビタミン剤、抗生物質、抗癌剤、等の薬液が充填されている。薬液収納部の材質はガラス、ポリプロピレン、ポリエチレン、ポリスチレン、各種エラストマー等の合成樹脂、あるいはステンレスやアルミニウム等の金属等が利用でき、後述する薬液吐出機構の構造に応じて適切な材料を選択することができるが、充填された薬液を目視できるように透明性のある材料であることが好ましい。また、既充填薬液容器の滅菌時あるいは保管中の雰囲気に含まれる酸素等のガスや水分によって変質しやすい薬液が充填されている場合にはそれぞれガス非透過性、水分非透過性の材質を選択することが好ましい。これらの例としてはガラスや、ステンレスやアルミニウム等の金属、合成樹脂では環状ポリオレフィン、ポリビニルアルコール等が好ましく、合成樹脂を酸化珪素や酸化アルミニウムあるいは上記したガス・水分非透過性樹脂で被覆したもの、さらに、必要に応じてこれらを層成分の一つとして多層構造としたものがある。また、既充填薬液容器は湿熱滅菌されるので、これに耐える耐熱性を有することが好ましい。   The chemical solution storage section is filled with a chemical solution such as a vitamin agent, an antibiotic, an anticancer agent, or the like according to the application in the internal space. The material of the chemical solution storage portion can be made of glass, polypropylene, polyethylene, polystyrene, a synthetic resin such as various elastomers, or a metal such as stainless steel or aluminum.Select an appropriate material according to the structure of the chemical solution discharge mechanism described later. However, it is preferable that the material is transparent so that the filled liquid medicine can be visually checked. In addition, when the filled chemical solution container is filled with a chemical solution that is easily degraded by gas or moisture such as oxygen contained in the atmosphere during sterilization or during storage, select a material that is gas-impermeable and moisture-impermeable. Is preferred. Examples of these are glass, metals such as stainless steel and aluminum, and synthetic resins such as cyclic polyolefin and polyvinyl alcohol are preferable, and those obtained by coating a synthetic resin with silicon oxide, aluminum oxide, or the above-described gas / water-impermeable resin, Further, if necessary, there is a type having a multilayer structure as one of the layer components. Further, since the filled chemical solution container is sterilized by wet heat, it is preferable that the already-filled chemical solution container has heat resistance to withstand the sterilization.

ノズルは薬液収納部内に充填された薬液を外部に吐出できる内部通路を有しており、通路の両端は外部と薬液収納部とにそれぞれ連通している。そしてノズルは薬液収納部と一体に同一の材料で形成されることが望ましい。   The nozzle has an internal passage through which the liquid medicine filled in the liquid medicine storage section can be discharged to the outside, and both ends of the path communicate with the outside and the liquid medicine storage section, respectively. The nozzle is desirably formed of the same material integrally with the chemical solution storage unit.

次に、薬液吐出機構について説明する。薬液吐出機構は、充填された薬液を薬液収納部からノズルを介して外部に吐出するためのものであり、薬液に対して圧を加えることにより吐出する構造をとることが好ましい。   Next, the chemical solution discharging mechanism will be described. The chemical solution discharge mechanism is for discharging the filled chemical solution from the chemical solution storage portion to the outside via the nozzle, and preferably has a structure in which the chemical solution is discharged by applying pressure to the chemical solution.

具体的には、薬液収納部を合成樹脂等で柔軟に形成し、薬液収納部に外圧を加えて薬液を加圧することで吐出可能とするよう構成したものがある。薬液収納部を形成する材料としては、ポリ塩化ビニル、ポリプロピレン、ポリエチレン、各種エラストマー等の合成樹脂が挙げられ、やや硬い材料を採用する場合には薬液を加圧しやすいように薄くしたり、添加剤により軟質化することが好ましい。なお、選択した薬液収納部の形成材料ではノズルとしての硬度が不十分と判断される場合には別部材でノズルを形成し、薬剤収納部と一体化することもできる。   Specifically, there is a configuration in which a chemical solution storage portion is formed of a synthetic resin or the like flexibly, and an external pressure is applied to the chemical solution storage portion to pressurize the chemical solution, thereby enabling discharge. Examples of the material for forming the chemical solution storage portion include synthetic resins such as polyvinyl chloride, polypropylene, polyethylene, and various elastomers. When a slightly hard material is used, the chemical solution is thinned so as to easily pressurize the chemical solution, and an additive is used. Is preferred. When it is determined that the hardness of the nozzle is insufficient with the selected material for forming the chemical solution storage section, the nozzle may be formed of a separate member and integrated with the drug storage section.

また、いわゆるシリンジ状に薬液収納部を構成することにより、既充填薬液容器に薬液吐出機構を付与することもできる。すなわち、硬質の薬液収納部を一端が開放し他端が閉塞した筒状体に形成し、開放している一端を液密に封止し筒状体内を軸方向に液密に摺動可能とするガスケットと、閉塞している他端側にノズルとが設けられていることにより薬液収納部の薬液を吐出可能とするよう構成されている。ガスケットには予めあるいは使用時直前にプランジャーを結合し、薬液の吐出を容易にすることが好ましい。予め結合してある場合は、ガスケットとプランジャーを嵌合によって結合したり、一体成形によって一体的に成形することができる。また、使用時直前に両者を結合する場合は、ガスケットとプランジャーに一対の雌雄ネジを設けたり、ラチェット機構を採用することができる。筒状体を形成する材料は、筒状体を硬質とすることができる材料であり、ガラス、ステンレスやアルミニウム等の金属、合成樹脂ではポリプロピレンや環状ポリオレフィン等が好ましい。ガスケットを形成する材料は、天然ゴムや合成ゴム、各種エラストマーが使用できる。また、プランジャーの形成材料は、薬液の吐出や吸引の操作に耐える硬質材料で形成され、ガラス、ステンレスやアルミニウム等の金属、ポリプロピレンやポリスチレン等の硬質合成樹脂等、各種硬質材料から適宜選択できる。   Further, by configuring the chemical liquid storage section in a so-called syringe shape, a chemical liquid discharge mechanism can be provided to the already filled chemical liquid container. That is, a hard chemical solution storage part is formed in a cylindrical body having one end opened and the other end closed, and the open one end is liquid-tightly sealed and slidable axially and liquid-tight within the cylindrical body. By providing a gasket to be closed and a nozzle at the other end that is closed, the liquid medicine in the liquid medicine storage section can be discharged. It is preferable that a plunger is connected to the gasket in advance or immediately before use to facilitate discharge of the chemical solution. In the case where the gasket and the plunger are connected in advance, the gasket and the plunger can be connected by fitting, or can be integrally formed by integral molding. In the case where the two are connected immediately before use, a pair of male and female screws may be provided on the gasket and the plunger, or a ratchet mechanism may be employed. The material forming the tubular body is a material that can make the tubular body hard, and is preferably glass, a metal such as stainless steel or aluminum, or a synthetic resin such as polypropylene or cyclic polyolefin. As a material for forming the gasket, natural rubber, synthetic rubber, and various elastomers can be used. Further, the material for forming the plunger is formed of a hard material that can withstand the operation of discharging or sucking a chemical solution, and can be appropriately selected from various hard materials such as glass, metals such as stainless steel and aluminum, and hard synthetic resins such as polypropylene and polystyrene. .

本発明のキャップは、容器本体に装着され、薬液収納部に充填された薬液が使用時までノズルから吐出しないよう封止するものである。このキャップは、閉塞端(先端)と開口端(基端開口)とを有する中空体で構成され、閉塞端側ではノズル先端開口を液密に封止している。   The cap of the present invention is mounted on the container main body and seals the chemical liquid filled in the chemical liquid storage part so as not to be discharged from the nozzle until use. This cap is formed of a hollow body having a closed end (distal end) and an open end (base end opening), and closes the nozzle distal end opening in a liquid-tight manner on the closed end side.

キャップを構成するキャップ本体は、ステンレスやアルミニウム等の金属、ポリエチレンやポリプロピレン等の合成樹脂等で形成することができ、ノズルの先端開口に当接した部分である封止部材を加硫天然ゴムや合成ゴム、各種エラストマー等の弾性体で形成すればより確実に封止することができ好ましい。また、封止部材の少なくとも中央部を針で刺通可能な合成樹脂やゴム等の材質、好ましくは再シール性を有するものや刺通した中空針にコアリングを生じさせにくい材質を有するもので形成すれば、キャップをノズルに取り付けたまま両頭針等の中空針を封止部材の中央部に直接刺通して薬液の投与等を行うようにすることもできる。その際、封止部材中央部がキャップ先端の外周縁より引き込んだ位置に設けられていれば、キャップまたはキャップ付きの既充填薬液容器を包装から取り出しても中空針の刺通部となる部分が汚染されないようにすることができる。引き込みの距離(=貫通孔の深さ)は2mm以上とることが好ましい。   The cap body that constitutes the cap can be formed of a metal such as stainless steel or aluminum, a synthetic resin such as polyethylene or polypropylene, or the like. It is preferable to use an elastic body such as a synthetic rubber or various elastomers, since the sealing can be more reliably performed. Further, at least the central portion of the sealing member is made of a material such as synthetic resin or rubber that can be pierced with a needle, preferably a material having resealability or a material that does not easily cause coring in the pierced hollow needle. If formed, a hollow needle such as a double-ended needle can be directly pierced into the center of the sealing member while the cap is attached to the nozzle to administer the drug solution. At that time, if the central portion of the sealing member is provided at a position retracted from the outer peripheral edge of the tip of the cap, the portion that becomes the piercing portion of the hollow needle even when the cap or the already-filled drug solution container with the cap is removed from the packaging. It can be protected from contamination. The drawing distance (= depth of the through hole) is preferably 2 mm or more.

また、キャップ閉塞端内面に凸部を形成し、凸部がノズル内面に嵌入した状態で凸部とノズル内面との間で封止するようにしても良い。この場合、両者間の封止はテーパ嵌合で構成することも、凸部を弾性体としノズル内面に密着させることによってもできる。   Alternatively, a convex portion may be formed on the inner surface of the closed end of the cap, and sealing may be performed between the convex portion and the inner surface of the nozzle with the convex portion fitted into the inner surface of the nozzle. In this case, the sealing between them can be made by taper fitting or by making the protruding portion an elastic body and closely contacting the inner surface of the nozzle.

キャップはさらに基端においてノズルと係止する係止部を有している。係止部は滅菌時に水蒸気がキャップとノズルの間に侵入するための隙間を有している。この隙間は例えば、係止部を一対の雄雌ネジで構成することにより生じるネジ間の隙間を利用することができる。   The cap further has a locking portion for locking the nozzle at the base end. The locking portion has a gap for allowing steam to enter between the cap and the nozzle during sterilization. The gap can be, for example, a gap between screws formed by forming the locking portion with a pair of male and female screws.

キャップ内部の閉塞端と開放端との中間部にはキャップ内面とノズル外表面とで形成される空間部が設けられている。この空間部により、滅菌のためにノズルとキャップの間に導入された水蒸気を滅菌後、容易に排出し乾燥させることができる。キャップ内面とノズル外表面との間隔は0.2〜1mmが好ましい。   A space formed by the inner surface of the cap and the outer surface of the nozzle is provided at an intermediate portion between the closed end and the open end inside the cap. With this space, the steam introduced between the nozzle and the cap for sterilization can be easily discharged and dried after sterilization. The distance between the inner surface of the cap and the outer surface of the nozzle is preferably 0.2 to 1 mm.

なお、キャップを形成する各部品はいずれも透明性を有することが液漏れ等の確認を容易にするために好ましい。また、ノズルや薬液収納部も同様の理由あるいは内容物の確認のために透明性を有することが好ましい。   In addition, it is preferable that all the components forming the cap have transparency in order to facilitate confirmation of liquid leakage and the like. Further, it is preferable that the nozzle and the chemical solution storage portion have transparency for the same reason or for confirming the contents.

以下図示したプレフィルドシリンジに基づいて本発明を詳細に説明する。
図1は、本発明の一実施例に係るプレフィルドシリンジの縦断面図であり、図2は、本発明のキャップの一実施例を示す縦断面図である。プレフィルドシリンジ1はシリンジ本体2とキャップ3とから構成されている。シリンジ本体2は薬液Aが充填された筒状体21、ノズル22、ガスケット23およびプランジャー24を有している。筒状体21は筒状のポリプロピレンや環状オレフィン等からなり、先端が閉塞し基端は開口している。該基端には一対のフランジ21aが対向して設けられている。閉塞した先端にはノズル22が筒状体21と一体に設けられ、充填された薬液Aを該ノズル22を介して吐出可能とする内部通路22aを有している。ノズル22は基端側外側面にキャップ3の基端側と対をなして螺合部を構成する雄ネジ22bを有している。また、雄ネジ22bより先端側の外側面はルアーテーパとし、三方活栓等への接続を可能にしている。筒状体21の基端開口よりガスケット23が筒状体内面と液密を維持した状態で軸方向に摺動可能なように挿入され、薬液Aの筒状体基端方向への移動を規制している。ガスケット23はブチルゴムや加硫天然ゴム等で形成され、摺動性を向上させるために必要に応じてシリコーン等の潤滑剤を塗布したり、摺動部分に低摩擦係数を有するフッ素樹脂等の合成樹脂を配しても良い。ガスケット23の基端にはポリプロピレン等の材質からなるプランジャー24がネジ嵌合により固定されている。従って、使用前はガスケット23から外しておけるので収納空間を小さくすることができる。
Hereinafter, the present invention will be described in detail based on the illustrated prefilled syringe.
FIG. 1 is a longitudinal sectional view of a prefilled syringe according to one embodiment of the present invention, and FIG. 2 is a longitudinal sectional view showing one embodiment of a cap of the present invention. The prefilled syringe 1 includes a syringe main body 2 and a cap 3. The syringe body 2 has a cylindrical body 21 filled with the chemical solution A, a nozzle 22, a gasket 23, and a plunger 24. The tubular body 21 is made of tubular polypropylene, cyclic olefin, or the like, and has a closed front end and an open base end. A pair of flanges 21a are provided at the base end so as to face each other. At the closed end, a nozzle 22 is provided integrally with the tubular body 21, and has an internal passage 22 a through which the filled chemical solution A can be discharged through the nozzle 22. The nozzle 22 has a male screw 22b on the base end side outer surface that forms a threaded part in a pair with the base end side of the cap 3. The outer surface on the tip side from the male screw 22b is a luer taper to enable connection to a three-way cock. The gasket 23 is inserted from the base end opening of the cylindrical body 21 so as to be slidable in the axial direction while maintaining the liquid tightness with the inner surface of the cylindrical body, thereby restricting the movement of the chemical solution A in the base direction of the cylindrical body. are doing. The gasket 23 is formed of butyl rubber, vulcanized natural rubber, or the like, and may be coated with a lubricant such as silicone as necessary to improve the sliding property, or may be formed of a synthetic resin such as a fluororesin having a low friction coefficient on the sliding portion. A resin may be provided. A plunger 24 made of a material such as polypropylene is fixed to the base end of the gasket 23 by screw fitting. Therefore, the storage space can be reduced since the gasket 23 can be removed before use.

キャップ3はキャップ本体31とゴム膜(封止部材:中空針を刺通可能な再シール性ゴム部材)32とで構成されている。ノズル22にはキャップ3が被冠され、ゴム膜32がノズル22の内部通路22aをその先端開口において封止し、充填された薬液Aが筒状体先端方向への移動を規制している。   The cap 3 includes a cap body 31 and a rubber film (sealing member: a resealable rubber member capable of penetrating a hollow needle) 32. The nozzle 22 is covered with the cap 3, the rubber film 32 seals the internal passage 22 a of the nozzle 22 at the opening at the end, and restricts the movement of the filled chemical solution A toward the end of the cylindrical body.

図2に示すように、キャップ本体31は先端中央部に貫通孔31aを有しており、該貫通孔31aは注射針(中空針)が刺通しやすいようにテーパが施され、またキャップ本体31の先端部を肉厚に形成することにより貫通孔両端間の距離が大きくとられ、後述するゴム膜32が図示しない包材から開封され外部雰囲気に晒された際にも汚染されないようになっている。キャップ本体31の基端部内面には先述のノズル22の雄ネジ22bと対をなす雌ネジ(係止部)31bを有している。雄ネジ22bと雌ネジ31bとは螺合した状態で軸方向に気体流通可能な隙間Bを有しており、滅菌用水蒸気がキャップとノズルの間に侵入でき、この部分の滅菌が確実に行えるよう構成されている。ゴム膜32は、貫通孔31aの基端開口を覆うようにキャップ本体31の内部に固定され、キャップ3をノズル22に螺合し係止した際にノズル22の先端開口を液密に封止している。ゴム膜32は加硫天然ゴム、合成ゴムあるいは各種エラストマー製で再シール性を有しており、厚さは0.1〜1mmが好ましい。   As shown in FIG. 2, the cap body 31 has a through hole 31a at the center of the tip, and the through hole 31a is tapered so that an injection needle (hollow needle) can be easily pierced. By forming the tip portion to have a large thickness, the distance between both ends of the through hole is increased, so that the rubber film 32 described below is not contaminated even when it is opened from a packaging material (not shown) and exposed to the outside atmosphere. . The inner surface of the base end of the cap body 31 has a female screw (locking portion) 31b that is paired with the male screw 22b of the nozzle 22 described above. The male screw 22b and the female screw 31b have a gap B in which gas can flow in the axial direction in a screwed state, and steam for sterilization can enter between the cap and the nozzle, and this portion can be surely sterilized. It is configured as follows. The rubber film 32 is fixed to the inside of the cap body 31 so as to cover the base end opening of the through hole 31a, and when the cap 3 is screwed into the nozzle 22 and locked, the tip end opening of the nozzle 22 is liquid-tightly sealed. are doing. The rubber film 32 is made of vulcanized natural rubber, synthetic rubber or various elastomers and has resealability, and preferably has a thickness of 0.1 to 1 mm.

次に、貫通孔31aの形状について図2を参照しつつ説明する。図2に示すように、貫通孔31aは、先端側に位置しその内径が一定の大径部311と、基端側に位置し前記大径部311の内径より小さい内径の小径部313と、大径部311と小径部313との間に位置しその内径が基端方向に向かって漸減するようなテーパが施されたテーパ部312とで構成されている。テーパ部312の内面(テーパ面)は、中空針をゴム膜32に穿刺する際にその中空針を案内、誘導する機能を有する。   Next, the shape of the through hole 31a will be described with reference to FIG. As shown in FIG. 2, the through-hole 31 a has a large-diameter portion 311 located at the distal end and having a constant inner diameter, a small-diameter portion 313 located at the base end and having an inner diameter smaller than the inner diameter of the large-diameter portion 311, The tapered portion 312 is located between the large diameter portion 311 and the small diameter portion 313 and is tapered such that the inside diameter gradually decreases toward the base end. The inner surface (tapered surface) of the tapered portion 312 has a function of guiding and guiding the hollow needle when the hollow needle is punctured into the rubber film 32.

キャップ本体31の先端面には、貫通孔31aの先端開口を囲むようにリング状のリブ31eが突出形成されている。このリブ31eを設けることにより、横方向からの貫通孔31aへの異物や細菌の侵入の阻止に役立つ。また、プレフィルドシリンジを包材から取り出した後、使用直前までキャップ本体31の先端面にフィルム等が貼られた場合、これを剥がしやすいという効果もある。   A ring-shaped rib 31e protrudes from the distal end surface of the cap body 31 so as to surround the distal end opening of the through hole 31a. The provision of the rib 31e helps to prevent foreign substances and bacteria from entering the through hole 31a from the lateral direction. In addition, after the prefilled syringe is taken out of the packaging material, if a film or the like is stuck to the tip surface of the cap body 31 until immediately before use, there is also an effect that the film is easily peeled off.

キャップ本体31の外周面には、軸方向に伸びる溝31fが形成されている。この溝31fの設置により、キャップ3を把持して回転操作する際等の滑り止め機能を発揮する。   A groove 31 f extending in the axial direction is formed on the outer peripheral surface of the cap body 31. By providing the groove 31f, a non-slip function is exhibited when the cap 3 is gripped and rotated.

キャップ3においては、ノズル22の外側面(外周面)からキャップ3の先端内面と雌ネジ31bとの間の内側面(内周面)31cを離間するよう構成したことにより空間Cを形成してある。この空間Cによって、滅菌時にノズル−キャップ間に導入された水蒸気を滅菌後容易に排出し乾燥することが可能となる。   In the cap 3, a space C is formed by separating the inner surface (inner peripheral surface) 31c between the inner surface of the tip of the cap 3 and the female screw 31b from the outer surface (outer peripheral surface) of the nozzle 22. is there. This space C makes it possible to easily discharge and dry the steam introduced between the nozzle and the cap during sterilization after sterilization.

本実施例について、キャップとノズル間の滅菌後の乾燥状態について実験を行った。キャップ本体31に厚さ0.2mmのブチルゴム製のゴム膜32を固定し、かつノズル22とキャップ内面との間隔が0.5mmであるポリプロピレン製のキャップ3を作成した。これを生理食塩水20mlを充填した環状ポリオレフィン製20ml容量のシリンジのノズルに装着した。比較例としてキャップの代わりにノズル外面に密着したゴムキャップを同様の生理食塩水充填シリンジに装着した。実施例及び比較例各25本について105℃の高圧蒸気滅菌またはスプレー滅菌を行った。この2種類の滅菌によりスプレー滅菌では蒸気の侵入の確認を、高圧蒸気滅菌では滅菌終了時の乾燥状態の確認を行い、結果をそれぞれ表1、表2に示した。本発明に係るプレフィルドシリンジは、キャップ−ノズル間の滅菌、乾燥ともに良好に行えることが分かった。   For this example, an experiment was conducted on the dry state after sterilization between the cap and the nozzle. A rubber film 32 made of butyl rubber having a thickness of 0.2 mm was fixed to the cap body 31, and a cap 3 made of polypropylene having a gap of 0.5 mm between the nozzle 22 and the inner surface of the cap was prepared. This was attached to a 20 ml syringe nozzle made of cyclic polyolefin filled with 20 ml of physiological saline. As a comparative example, instead of the cap, a rubber cap closely attached to the outer surface of the nozzle was attached to the same syringe filled with physiological saline. High-pressure steam sterilization or spray sterilization at 105 ° C. was performed on each of 25 tubes in each of Examples and Comparative Examples. The two types of sterilization were used to confirm the invasion of steam in spray sterilization, and to confirm the dry state at the end of sterilization in high-pressure steam sterilization. The results are shown in Tables 1 and 2, respectively. It has been found that the prefilled syringe according to the present invention can perform both sterilization and drying between the cap and the nozzle satisfactorily.

Figure 2004321826
Figure 2004321826

Figure 2004321826
Figure 2004321826

次に、本発明に係るプレフィルドシリンジの使用例について説明する。プレフィルドシリンジに充填された薬液を輸液バッグに混注したり、患者血管へ直接注射する際には、2通りの方法がある。ひとつは、キャップ3を外してノズル22を露出させ、そこに三方活栓やチューブ等の雌ルアーコネクター、あるいは注射針のハブを接続し、これらの用途に供するものである。もうひとつは、キャップ3のゴム膜32に中空針の内針を刺通し、内針とは反対側に設けられた外針またはコネクターを有するホルダーをキャップ3に接続するものである。図3はホルダー4の部品図(縦断面図)であり、ホルダー4はホルダー本体41とマルチ針(両頭針)42とからなっている。   Next, an example of use of the prefilled syringe according to the present invention will be described. There are two methods for injecting a drug solution filled in a prefilled syringe into an infusion bag or injecting directly into a patient's blood vessel. One is to remove the cap 3 to expose the nozzle 22 and connect a female luer connector such as a three-way cock or a tube, or a hub of an injection needle to the nozzle 22 for these uses. The other is to pierce the rubber film 32 of the cap 3 with an inner needle of a hollow needle and connect the holder having an outer needle or a connector provided on the side opposite to the inner needle to the cap 3. FIG. 3 is a component diagram (longitudinal sectional view) of the holder 4. The holder 4 includes a holder main body 41 and a multi-needle (double-ended needle) 42.

ホルダー本体41はプレフィルドシリンジの1のキャップ3を収納する収納部41aとマルチ針42を固定するホルダー雌ネジ41bとホルダー内周面にホルダー環状凸部41cを有している。マルチ針42は互いに連通する内部通路を有する中空針であるステンレスや合成樹脂製の内針42aおよび外針42bを有し、両者の間にハブ42cが設けられ、該ハブ42cには先述のホルダー雌ネジ41bと螺合する雄ネジ42dが形成されている。また、内針42aを覆うように加硫天然ゴムや合成ゴムあるいは各種エラストマー製の再シール性を有するゴムチップ42eが設けられている。従って、外針42bを輸液バッグ等の混注口に穿刺したままにしても内針42aが露出せず、内針42aをプレフィルドシリンジ1のゴム膜32に刺通しているときのみ内針42aがゴムチップ42eから現れるので、複数本のプレフィルドシリンジを連続して注入することができる。また、血管への刺通時にはさらに外針42bが刺通した血管からの血液の逆流出を防止できる。なお、ホルダー4のホルダー環状凸部41cはキャップ3の外周面に設けられたキャップ環状凸部31dと係合し、内針42aをプレフィルドシリンジのゴム膜32に刺通したときにゴムチップ42eの復元力によりホルダー4からプレフィルドシリンジが脱落するのを防止している。   The holder main body 41 has a storage portion 41a for storing one cap 3 of the prefilled syringe, a female female screw 41b for fixing the multi-needle 42, and a holder annular convex portion 41c on the inner peripheral surface of the holder. The multi-needle 42 has an inner needle 42a and an outer needle 42b made of stainless steel or synthetic resin, which are hollow needles having internal passages communicating with each other, and a hub 42c is provided between the two needles. A male screw 42d screwed with the female screw 41b is formed. A rubber chip 42e made of vulcanized natural rubber, synthetic rubber, or various elastomers and having resealability is provided so as to cover the inner needle 42a. Therefore, the inner needle 42a is not exposed even when the outer needle 42b is punctured into the co-infusion port of the infusion bag or the like, and the inner needle 42a is inserted into the rubber tip 42e only when the inner needle 42a is pierced through the rubber film 32 of the prefilled syringe 1. Therefore, a plurality of prefilled syringes can be continuously injected. In addition, when piercing the blood vessel, it is possible to further prevent reverse outflow of blood from the blood vessel pierced by the outer needle 42b. Note that the holder annular projection 41c of the holder 4 engages with the cap annular projection 31d provided on the outer peripheral surface of the cap 3, and restores the rubber tip 42e when the inner needle 42a pierces the rubber film 32 of the prefilled syringe. The force prevents the prefilled syringe from dropping from the holder 4.

使用する手順は、まずホルダー本体41とマルチ針42とが組み立てられたホルダー4の外針42bを輸液容器等の混注口に穿刺する。次に本発明に係るプレフィルドシリンジ1のキャップ3の部分をホルダー4の収納部41a内に挿入して収納し、両者に設けられた環状凸部31d、41cを係合させ、ホルダー4にプレフィルドシリンジ1を装着する。このときホルダー4の内針42aがゴムチップ42eを貫通し、キャップ3のゴム膜32を刺通する。このときの状態を図4に示す。次に、プレフィルドシリンジ1のプランジャー24の操作により充填された薬液を混注口より輸液容器等に注入する。注入が完了した後、プレフィルドシリンジ1をキャップ3ごとホルダー4から取り外し、複数の薬液を同一の輸液容器等に注入する場合には同様に薬液の充填された他のプレフィルドシリンジをホルダー4に順次装着して薬液を注入する。また、これらの薬液の混注操作中のゴムチップ42eは、ホルダー4からプレフィルドシリンジが抜き取られるごとに元の形状に復元し、液の飛散や浮遊菌による汚染を防止している。   First, the outer needle 42b of the holder 4 in which the holder body 41 and the multi-needle 42 are assembled is punctured into a co-infusion port of an infusion container or the like. Next, the portion of the cap 3 of the prefilled syringe 1 according to the present invention is inserted and stored in the storage portion 41a of the holder 4, and the annular convex portions 31d and 41c provided on both sides are engaged, and the prefilled syringe is attached to the holder 4. 1 is attached. At this time, the inner needle 42a of the holder 4 penetrates the rubber chip 42e and penetrates the rubber film 32 of the cap 3. The state at this time is shown in FIG. Next, the liquid medicine filled by the operation of the plunger 24 of the prefilled syringe 1 is injected into the infusion container or the like from the co-injection port. After the injection is completed, the pre-filled syringe 1 is removed together with the cap 3 from the holder 4, and when a plurality of liquid medicines are to be injected into the same infusion container or the like, other pre-filled syringes filled with the liquid medicines are similarly sequentially attached to the holder 4. And inject the drug solution. Further, the rubber tip 42e during the co-injection operation of these chemicals is restored to the original shape each time the prefilled syringe is extracted from the holder 4, thereby preventing the liquid from scattering and contamination by floating bacteria.

本実施例についてキャップ3の先端側に位置するゴム膜32の汚染について実験を行った。上記実験と同様に作成し、ゴム膜32をキャップ本体31の先端面より2mm(=貫通孔31aの深さ)の位置に着けたキャップ3を装着したプレフィルドシリンジのゴム膜32に上記ホルダー4の内針42aを刺通した。内針42aがゴムチップ42eおよびゴム膜32を貫通した状態で、プレフィルドシリンジのプランジャー24を押し込み、プレフィルドシリンジ内の薬液を吐出する操作について、従来のシリンジ(比較例)を使用した混注操作との微生物汚染の点より比較を行った。比較方法は、実施例のキャップ先端及び比較例のシリンジノズル先端へ強制的に微生物を付着させ、ホルダー又は注射針を使用して混注操作を行い、薬液への菌の侵入を比較した。具体的には、保存してあるStaphylococcus Epidermidis(ATCC株番号:No.14990株)をTSA培地上に画線しこれを37℃、24時間培養した後、菌をコンラージ棒で均一の厚さになるように画線したものを用意した。次に実施例では菌繁殖培地に垂直にキャップの先端を押しつけ、比較例ではノズル先端を同様にして押しつけた後、それぞれ上述の混注操作を行い、薬液内への混入菌数を測定した。結果を表3に示す。本発明に係るプレフィルドシリンジはキャップ先端面より2mmの位置にゴム膜を配し封止部材としたため、先端が露出する比較例に比べて汚染がないことが確認された。   In this example, an experiment was conducted on the contamination of the rubber film 32 located on the tip side of the cap 3. In the same manner as in the above experiment, the rubber film 32 was attached to the rubber film 32 of the prefilled syringe with the cap 3 attached at a position 2 mm (= depth of the through hole 31a) from the tip end surface of the cap body 31. The inner needle 42a was pierced. With the inner needle 42a penetrating the rubber tip 42e and the rubber film 32, the operation of pushing the plunger 24 of the prefilled syringe and discharging the chemical solution in the prefilled syringe differs from the co-injection operation using the conventional syringe (comparative example). A comparison was made in terms of microbial contamination. In the comparative method, microorganisms were forcibly attached to the tip of the cap of the example and the tip of the syringe nozzle of the comparative example, and a co-injection operation was performed using a holder or an injection needle to compare the invasion of the bacteria into the drug solution. Specifically, the stored Staphylococcus Epidermidis (ATCC strain number: No. 14990 strain) is streaked on a TSA medium and cultured at 37 ° C. for 24 hours. I prepared a stitched image. Next, in the example, the tip of the cap was pressed vertically against the bacterial growth medium, and in the comparative example, the tip of the nozzle was pressed in the same manner, and then the above-described co-injection operation was performed to measure the number of bacteria mixed into the drug solution. Table 3 shows the results. Since the prefilled syringe according to the present invention provided a sealing member with a rubber film disposed at a position 2 mm from the tip end surface of the cap, it was confirmed that there was no contamination as compared with the comparative example in which the tip end was exposed.

Figure 2004321826
Figure 2004321826

本発明に係るプレフィルドシリンジの縦断面図である。It is a longitudinal section of a prefilled syringe concerning the present invention. 本発明に係るキャップの縦断面図である。It is a longitudinal section of a cap concerning the present invention. 本発明に係るプレフィルドシリンジに装着され使用されるホルダーの縦断面図である。It is a longitudinal section of a holder attached to and used for the prefilled syringe concerning the present invention. 本発明に係るプレフィルドシリンジの使用状態を示す説明図である。It is an explanatory view showing a use state of a prefilled syringe concerning the present invention.

符号の説明Explanation of reference numerals

1 プレフィルドシリンジ(既充填薬液容器)
2 シリンジ本体
21 筒状体
21a フランジ
22 ノズル
22a 内部通路
22b 雄ネジ
23 ガスケット
24 プランジャー
3 キャップ
31 キャップ本体
31a 貫通孔
311 大径部
312 テーパ部
313 小径部
31b 雌ネジ
31c 内側面
31d キャップ環状凸部
31e リブ
31f 溝
32 ゴム膜
A 薬液
B 隙間
C 空間(空間部)
4 ホルダー
41 ホルダー本体
41a 収納部
41b 雌ネジ
41c ホルダー環状凸部
42 マルチ針
42a 内針
42b 外針
42c ハブ
42d 雄ネジ
42e ゴムチップ
1 prefilled syringe (prefilled drug solution container)
2 Syringe body 21 Cylindrical body 21a Flange 22 Nozzle 22a Internal passage 22b Male screw 23 Gasket 24 Plunger 3 Cap 31 Cap body 31a Through hole 311 Large diameter portion 312 Tapered portion 313 Small diameter portion 31b Female screw 31c Inner side surface 31d Cap annular convex Part 31e rib 31f groove 32 rubber film A chemical liquid B gap C space (space part)
4 Holder 41 Holder body 41a Storage portion 41b Female screw 41c Holder annular convex portion 42 Multi needle 42a Inner needle 42b Outer needle 42c Hub 42d Male screw 42e Rubber tip

Claims (8)

薬液を吐出するノズルを備え薬液が充填された薬液容器の前記ノズルに被冠され、前記ノズルの先端開口を液密に封止するキャップであって、
先端中央部に貫通孔を有し基端が開放端となっており、かつ基端側において隙間を有した状態で前記ノズルと係止する係止部を有するキャップ本体と、
前記貫通孔の基端開口を塞ぐように前記キャップ本体内に設置され、前記係止部が前記ノズルに係止した状態で前記ノズルの先端開口を液密に封止する封止部材とを備え、
前記貫通孔は、その内径が基端方向に向かって漸減するようなテーパが施されたテーパ部を有することを特徴とするキャップ。
A cap that is provided with a nozzle that discharges a chemical liquid and is covered by the nozzle of the chemical liquid container filled with the chemical liquid, and seals a tip opening of the nozzle in a liquid-tight manner,
A cap body having a through hole in the center of the distal end, the base end being an open end, and having a locking portion that locks with the nozzle with a gap on the base end side;
A sealing member that is installed in the cap body so as to close a base end opening of the through hole, and seals a tip end opening of the nozzle in a liquid-tight manner with the locking portion locked to the nozzle. ,
The cap, wherein the through hole has a tapered portion whose inner diameter gradually decreases toward a base end.
薬液を吐出するノズルを備え薬液が充填された薬液容器の前記ノズルに被冠され、前記ノズルの先端開口を液密に封止するキャップであって、
先端中央部に貫通孔を有し基端が開放端となっており、かつ基端側において隙間を有した状態で前記ノズルと係止する係止部を有するキャップ本体と、
前記貫通孔の基端開口を塞ぐように前記キャップ本体内に設置され、前記係止部が前記ノズルに係止した状態で前記ノズルの先端開口を液密に封止する封止部材とを備え、
前記貫通孔は、先端側に位置し、内径が一定の大径部、基端側に位置し、前記大径部の内径より小さい内径の小径部、および前記大径部と前記小径部との間に位置し、内径が基端方向に向かって漸減するようなテーパが施されたテーパ部で構成されていることを特徴とするキャップ。
A cap that is provided with a nozzle that discharges a chemical liquid and is covered by the nozzle of the chemical liquid container filled with the chemical liquid, and seals a tip opening of the nozzle in a liquid-tight manner,
A cap body having a through hole in the center of the distal end, the base end being an open end, and having a locking portion that locks with the nozzle with a gap on the base end side;
A sealing member that is installed in the cap body so as to close a base end opening of the through hole, and seals a tip end opening of the nozzle in a liquid-tight manner with the locking portion locked to the nozzle. ,
The through-hole is located at the distal end, the large diameter portion having a constant inner diameter, located at the base end, the small diameter portion having an inner diameter smaller than the inner diameter of the large diameter portion, and the large diameter portion and the small diameter portion A cap which is located between and has a tapered portion whose inner diameter gradually decreases in a proximal direction.
前記キャップ本体の先端面に、前記貫通孔の先端開口を囲むように、リング状のリブが突出形成されている請求項1または2に記載のキャップ。   3. The cap according to claim 1, wherein a ring-shaped rib protrudes from a distal end surface of the cap body so as to surround a distal end opening of the through hole. 4. 前記キャップ本体の外周面に、軸方向に伸びる溝が形成されている請求項1ないし3のいずれかに記載のキャップ。   The cap according to any one of claims 1 to 3, wherein a groove extending in an axial direction is formed on an outer peripheral surface of the cap body. 前記封止部材は、中空針を刺通可能な再シール性ゴム部材で構成されている請求項1ないし4のいずれかに記載のキャップ。   The cap according to any one of claims 1 to 4, wherein the sealing member is formed of a resealable rubber member through which a hollow needle can be pierced. 前記テーパ部の内面は、前記封止部材に刺通される中空針を案内する機能を有する請求項1ないし5のいずれかに記載のキャップ。   The cap according to any one of claims 1 to 5, wherein an inner surface of the tapered portion has a function of guiding a hollow needle penetrated by the sealing member. 前記キャップ本体および前記封止部材は、透明性を有するものである請求項1ないし6のいずれかに記載のキャップ。   The cap according to any one of claims 1 to 6, wherein the cap body and the sealing member have transparency. 内壁によって規定される空間に薬液を充填した薬液収納部と、該薬液収納部に収納された薬液を吐出するための開口を有するノズルと、薬液を吐出させる薬液吐出機構とを有する容器本体と、
請求項1ないし7のいずれかに記載のキャップとを備えてなることを特徴とする既充填薬液容器。
A container body having a liquid medicine storage section filled with a liquid medicine in a space defined by the inner wall, a nozzle having an opening for discharging the liquid medicine stored in the liquid medicine storage section, and a liquid medicine ejection mechanism for discharging the liquid medicine,
A pre-filled chemical liquid container comprising the cap according to any one of claims 1 to 7.
JP2004209195A 2004-07-15 2004-07-15 Cap and prefilled chemical container Expired - Fee Related JP3949124B2 (en)

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US10220160B2 (en) 2007-09-07 2019-03-05 Becton, Dickinson And Company Pen needle assembly for preventing under-torquing and over-torquing of pen needle
US9233216B2 (en) 2007-09-07 2016-01-12 Becton, Dickinson And Company Pen needle assembly for preventing under-torquing and over-torquing of pen needle
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CN108455064A (en) * 2018-02-08 2018-08-28 佛山科学技术学院 A kind of multi-functional dental planting body Packaging Bottle
CN108455064B (en) * 2018-02-08 2024-02-13 佛山科学技术学院 Multifunctional dental implant packaging bottle

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