JPH09108301A - Medical container and its manufacture - Google Patents

Medical container and its manufacture

Info

Publication number
JPH09108301A
JPH09108301A JP7293651A JP29365195A JPH09108301A JP H09108301 A JPH09108301 A JP H09108301A JP 7293651 A JP7293651 A JP 7293651A JP 29365195 A JP29365195 A JP 29365195A JP H09108301 A JPH09108301 A JP H09108301A
Authority
JP
Japan
Prior art keywords
container
wall
needle
elastic member
medical
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.)
Pending
Application number
JP7293651A
Other languages
Japanese (ja)
Inventor
Hiroshi Motobayashi
博志 本林
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.)
Material Engineering Technology Laboratory Inc
Original Assignee
Material Engineering Technology Laboratory Inc
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 Material Engineering Technology Laboratory Inc filed Critical Material Engineering Technology Laboratory Inc
Priority to JP7293651A priority Critical patent/JPH09108301A/en
Publication of JPH09108301A publication Critical patent/JPH09108301A/en
Pending legal-status Critical Current

Links

Abstract

PROBLEM TO BE SOLVED: To provide a medical container easily mountable on a wall and highly safe and economical in its manufacture by opening a discharge hole consisting of an elastic member and a retaining material for retaining the elastic member to the container, attachable to the wall of the container in an airtight state against a liquid learage between the wall of the container and the elastic member. SOLUTION: When using a medical container 1, first a gripping member for a peripheral edge sealing part is caused to hold the cylindrical part of a retaining material 6 for a discharge hole. Consequently, the container 1 is distorted resulting in the generation of a void in the container 1, so that it is possible to store and retain the tip of a communicating needle 11 in the void part 1A. Next, a sterile seal is stripped from the cylindrical part, and the communicating needle 11 for drip infusion is punctured into a rubber member 6. An infusion liquid 3 in the container 1 is flown into a patient through the needle 11. In this case, the needle 11 can be easily punctured through a rubber member 5 and an outer wall 2A. As the rubber member 5 is retained airtightly against a liquid leakage on the outer wall 2A, the infusion liquid 3 does not seep out of a puncture hole opened in the container wall 2A running through a space between the rubber member 5 and the container 1 to outside.

Description

【発明の詳細な説明】Detailed Description of the Invention

【0001】[0001]

【産業上の利用分野】本発明は、点滴注射などに用いら
れる輸液バックなどの医療用容器に関するものであり、
より詳細には、点滴用の連通針等が接続されて容器内の
輸液が排出される排出口を簡単かつ正確に取り付けるこ
とができる医療用容器に関する。
BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container such as an infusion bag used for drip injection.
More specifically, the present invention relates to a medical container in which a communication needle for drip or the like is connected and an outlet for discharging an infusion solution in the container can be easily and accurately attached.

【0002】[0002]

【従来の技術】一般に輸液バック、コンテナ等の医療用
容器は、壁が柔軟で可撓性があり、非定容積性のプラス
チック容器である。このような容器の樹脂としては、直
鎖状低密度ポリエチレン樹脂、高密度ポリエチレン樹
脂、ポリプロピレン樹脂、軟質ポリエステル樹脂、塩素
化ポリエチレン樹脂、塩化ビニル樹脂、エチレン−酢酸
ビニル共重合体等の可撓性に富んだ材料が用いられてい
る。また、容器成形物は、一般に2枚の押出し延伸成形
したシート又はフィルム、或いはインフレーション成形
した筒状シートなどを所定の大きさに裁断し、その周縁
端部を熱溶着シールすることにより形成される。また最
近はブロー成形による樹脂容器も既に提供されている。
2. Description of the Related Art Generally, a medical container such as an infusion bag or a container is a non-constant volume plastic container having a flexible wall. Examples of the resin for such a container include linear low-density polyethylene resin, high-density polyethylene resin, polypropylene resin, soft polyester resin, chlorinated polyethylene resin, vinyl chloride resin, ethylene-vinyl acetate copolymer, and other flexible materials. Rich in materials are used. In addition, a container molded product is generally formed by cutting two extruded stretch-molded sheets or films, or an inflation-molded tubular sheet into a predetermined size, and heat-sealing the peripheral edges thereof. . Recently, blow molding resin containers have already been provided.

【0003】また医療用容器は、点滴の際に輸液を取り
出す排出口を備えており、従来、排出口は樹脂口部材の
成形物からなる。口部材は容器本体を構成する二枚のシ
ートの間に挿入されて、口部材の外周壁が熱溶着により
シート内面に液密に固着される。またシート同士の周縁
がほぼ同時に熱溶着シールされ、口部材の開口から輸液
などが容器本体内に充填される。液の充填後、樹脂口部
材の開口にゴム栓体が取付けられ、ゴム栓体を口部材に
完全に液密固定するため、リング状の止め部材がゴム栓
体を挟んで樹脂口部材に固着される。そして、容器全体
がオートクレーブ滅菌される。
Further, the medical container is provided with a discharge port for taking out an infusion solution at the time of drip, and conventionally, the discharge port is made of a molded product of a resin mouth member. The mouth member is inserted between the two sheets forming the container body, and the outer peripheral wall of the mouth member is liquid-tightly fixed to the inner surface of the sheet by heat welding. Further, the peripheral edges of the sheets are heat-sealed almost at the same time, and an infusion solution or the like is filled in the container body through the opening of the mouth member. After filling the liquid, a rubber stopper is attached to the opening of the resin mouth member, and the rubber stopper is completely liquid-tightly fixed to the mouth member, so a ring-shaped stop member is fixed to the resin mouth member by sandwiching the rubber stopper. To be done. Then, the entire container is autoclaved.

【0004】[0004]

【発明が解決しようとする課題】しかしながら、従来の
医療用容器の排出口はその製造上極めて煩雑で、経済性
及び安全性にも問題がある。従来、排出口における口部
材は、筒状であり外周壁にシートが液密に熱溶着される
が、シール面が湾曲しシートは拠れた状態でシール手段
に接する。このため、液密な熱溶着シールが難しく、時
としてピンホールを生じることがある。またシール手段
の熱溶着部も湾曲して装置的にも耐久性が悪くなる。ま
た排出口のゴム栓体の内面は容器本体内に存在し、保存
中も常に輸液と接する。ゴム栓体はその弾性復元力を高
めて液密性を上げるため加硫化剤及びその促進剤が含ま
れ、これらが輸液に影響を与える場合がある。このた
め、ゴム栓体は成分の制限がなされ、その機能性に問題
が生じる。更に、排出口が取り付けられた後に、容器が
高圧蒸気滅菌されるため、排出口の各部材は相当の耐熱
性が要求され、その選択性の幅が限られるという問題が
ある。
However, the conventional outlet of the medical container is extremely complicated in manufacturing, and there is a problem in economical efficiency and safety. Conventionally, the mouth member of the discharge port is tubular and the sheet is heat-sealed to the outer peripheral wall in a liquid-tight manner. However, the sealing surface is curved and the sheet comes into contact with the sealing means. Therefore, liquid-tight heat-sealing is difficult, and pinholes sometimes occur. Further, the heat-welded portion of the sealing means is also curved and the durability of the apparatus is deteriorated. Further, the inner surface of the rubber stopper of the discharge port exists inside the container body and is always in contact with the infusion solution during storage. The rubber stopper contains a vulcanizing agent and its accelerator in order to enhance the elastic restoring force and liquid tightness, and these may affect the infusion. For this reason, the rubber stopper is limited in its components and causes a problem in its functionality. Furthermore, since the container is subjected to high-pressure steam sterilization after the discharge port is attached, there is a problem that each member of the discharge port is required to have considerable heat resistance and the range of its selectivity is limited.

【0005】従って、本発明の目的は、容器への取付が
簡単で、容器の高圧蒸気滅菌後も簡単取り付けることが
できる排出口を具備し、製造上の安全性、経済性が極め
て高い医療用容器を提供することにある。
Therefore, an object of the present invention is to provide a medical device which is easy to attach to a container and has a discharge port which can be easily attached even after high-pressure steam sterilization of the container, and which is extremely safe and economical in manufacturing. To provide a container.

【0006】[0006]

【課題を解決するための手段】本発明は、液を排出する
ための連通針の刺通が可能なプラスチック製容器壁を有
し、上記連通針の刺通可能な面積を有し、刺通された連
通針の外周壁を弾性力を介して圧迫して刺通孔を液密に
維持しうる弾性部材と、上記弾性部材を上記容器壁に止
め置き、かつ上記容器壁と上記弾性部材との間を液密に
して上記容器壁に取付られる止め材とからなる排出口を
有することを特徴とする医療用容器を提供することによ
り、上記目的を達成したものである。
The present invention has a plastic container wall through which a communicating needle for discharging a liquid can be pierced and has an area through which the communicating needle can be pierced. An elastic member capable of maintaining the piercing hole in a liquid-tight manner by pressing the outer peripheral wall of the communicating needle via an elastic force, and the elastic member being fixedly placed on the container wall, and the container wall and the elastic member. The above object is achieved by providing a medical container characterized in that it has a discharge port composed of a stopper member that is liquid-tightly attached to the container wall.

【0007】図4に示すごとく、容器1の外壁2は連通
針が刺通する柔軟なシートである。弾性部材であるゴム
部材5等でそのシート面である外壁2Aを液密に覆うこ
とにより、連通針11をゴム部材5及び容器壁2Aに刺
通したとしても、破封された容器壁2Aの刺通孔はゴム
部材5が液密に覆っており、容器内部の液3がゴム部材
5と容器外壁2A面との間を伝って外部に露出すること
はない。また、刺通されたゴム部材5の刺通孔5Aは、
ゴム部材5の弾性力により連通針11の外周縁を液密に
押圧しているので、ゴム部材5と容器外壁2A面との間
を伝った液3が刺通孔から漏れ出ることもない。このた
め、点滴用の連通針11がかかる排出口4に刺通された
としても、従来と同様に外部との液密性が維持される。
このため、従来の排出口と同様な機能を有してはいる
が、その製造は極めて簡単なものとなる。例えば、先
ず、容器に輸液を充填し、シートの周縁を熱溶着シール
して固着する。この場合、従来のように筒状の口部材を
間に挟んで熱溶着シールしないため、シールが確実にな
され、ピンホールなどが生じない。また弾性部材と止め
材とからなる排出口は、容器を高圧蒸気滅菌した後にも
取付けることができるため、容器の高圧蒸気滅菌以外の
滅菌をすることが可能となる。このため、弾性部材と止
め材とは、多少熱に弱いものを選択しても問題は生じな
い。更に、保存時、弾性部材は液に触れた状態でないた
め、弾性部材であるゴムなどから加流化剤、加流促進剤
などの溶出物は従来のように考える必要がない。このた
め、加硫化剤の多様な使用が可能となり、弾性復元力を
十分なものにすることができるため、刺通後のリシール
性に優れたものとなる。
As shown in FIG. 4, the outer wall 2 of the container 1 is a flexible sheet through which a communicating needle is pierced. Even if the communicating needle 11 is pierced through the rubber member 5 and the container wall 2A by liquid-tightly covering the outer wall 2A that is the sheet surface with the rubber member 5 that is an elastic member, the broken container wall 2A The piercing hole is covered with the rubber member 5 in a liquid-tight manner, and the liquid 3 inside the container is not exposed to the outside by being transmitted between the rubber member 5 and the surface of the container outer wall 2A. The piercing hole 5A of the pierced rubber member 5 is
Since the outer peripheral edge of the communication needle 11 is pressed liquid-tight by the elastic force of the rubber member 5, the liquid 3 that has passed between the rubber member 5 and the surface of the container outer wall 2A does not leak from the piercing hole. Therefore, even if the communication needle 11 for drip is pierced through the discharge port 4, the liquid tightness with the outside is maintained as in the conventional case.
Therefore, although it has a function similar to that of the conventional outlet, its manufacture is extremely simple. For example, first, a container is filled with an infusion solution, and the periphery of the sheet is fixed by heat-sealing. In this case, since the heat sealing is not performed by sandwiching the tubular mouth member as in the conventional case, the sealing is surely performed, and the pinhole or the like does not occur. Further, the outlet formed of the elastic member and the stopper can be attached even after the container has been subjected to high-pressure steam sterilization, so that the container can be sterilized other than the high-pressure steam sterilization. Therefore, even if the elastic member and the stopper are selected to be slightly heat-sensitive, no problem will occur. Furthermore, since the elastic member is not in contact with the liquid during storage, it is not necessary to consider eluates such as rubber, which is an elastic member, such as a mobilization agent and a accelerating accelerator as in the conventional case. Therefore, the vulcanizing agent can be used in various ways, and the elastic restoring force can be made sufficient, resulting in excellent resealability after piercing.

【0008】本発明に係る医療用容器において、上記排
出口の弾性部材には、上記弾性部材の刺通孔の形成面を
覆う無菌維持シール材が剥離可能に取付られていること
を特徴とするので、使用時まで連通針の刺通部分が無菌
に維持される。本発明に係る医療用容器において、上記
止め材は貼着材を介して上記外壁に取付けられ、該貼着
材は、上記弾性部材の上記一の面の全部又は一部を覆っ
ていることを特徴とすることにより、排出口を例えばガ
ス滅菌し、容器を高圧蒸気滅菌して別々の状態から、容
器に貼着材を介して排出口を取付け、その平坦な固着面
を電子線放射などで容易に滅菌することができる。この
ため、容器に排出口を取り付ける場合も極めて容易にで
きる。
In the medical container according to the present invention, an aseptic maintenance sealant covering the surface of the elastic member on which the puncture hole is formed is detachably attached to the elastic member of the discharge port. Therefore, the piercing part of the communication needle is maintained aseptic until use. In the medical container according to the present invention, the stopper is attached to the outer wall via an adhesive, and the adhesive covers all or part of the one surface of the elastic member. As a feature, the discharge port is sterilized by gas, the container is sterilized by high pressure steam, and the discharge port is attached to the container through the adhesive material. Can be easily sterilized. Therefore, it is extremely easy to attach the discharge port to the container.

【0009】本発明に係る医療用容器において、上記排
出口の止め材には、筒部が一体又は別体として取付ら
れ、上記筒部は上記容器の周縁シール部に係止されるこ
とを特徴とすることにより、連通針が刺通されたときで
も、容器内に十分な空隙が得られ、しかも、上記筒部に
指掛け部が形成されていることを特徴とすることによ
り、刺通における操作性が向上する。本発明に係る医療
用容器において、上記筒部内は滅菌されて無菌維持され
る無菌収容部として形成され、上記筒部内に上記連通針
が収容されていることを特徴とすることにより、無菌シ
ステムが一層達せられ、また上記連通針が、刺針部と管
部とが別体として形成され、刺通後に該刺針部が分離す
ることを特徴とすることにより、刺通後、連通針の刺針
部が他の容器壁に刺さる虞がない。また、上記管部は、
上記刺針部が取り付けられる開口端の反対側の開口端に
被刺通用弾性部材が設けられていることを特徴とするこ
とにより、点滴用の連通針を容易に連通させることがで
きる。更に、上記医療用容器の製造方法において、上記
排出口と容器との接続部を電子線照射により滅菌して製
造することを特徴とすることにより、製造ラインに簡単
に乗せて滅菌等を確実にすることができる。
In the medical container according to the present invention, a tubular portion is integrally or separately attached to the stopper of the discharge port, and the tubular portion is engaged with a peripheral seal portion of the container. By this, even when the communication needle is pierced, a sufficient space can be obtained in the container, and further, the finger hook portion is formed on the tubular portion. The property is improved. In the medical container according to the present invention, the inside of the tubular portion is formed as a sterile container that is sterilized and maintained aseptic, and the communication needle is housed in the tubular portion, whereby a sterile system is provided. Further, the communicating needle is characterized in that the needle portion and the tube portion are formed as separate bodies, and the needle portion is separated after the needle is inserted. There is no risk of sticking to other container walls. In addition, the pipe section,
Since the elastic member for piercing is provided at the opening end opposite to the opening end to which the puncturing part is attached, the communication needle for drip can be easily communicated. Furthermore, in the method for producing a medical container, the connecting portion between the outlet and the container is characterized by being sterilized by electron beam irradiation for production, so that it can be easily placed on the production line to ensure sterilization and the like. can do.

【0010】[0010]

【実施例】以下、本発明に係る医療用容器の好ましい実
施例を添付図面を参照しながら詳述する。図1は本発明
に係る医療用容器の第一実施例の正面図、図2(A)〜
(D)は第一実施例における排出口の断面図、図3は第
一実施例における医療用容器の排出口の断面図、図4は
第一実施例における医療用容器の使用時の排出口の断面
図である。
The preferred embodiments of the medical container according to the present invention will be described below in detail with reference to the accompanying drawings. 1 is a front view of a first embodiment of a medical container according to the present invention, FIG.
(D) is a sectional view of the outlet in the first embodiment, FIG. 3 is a sectional view of the outlet of the medical container in the first embodiment, and FIG. 4 is an outlet when the medical container in the first embodiment is used. FIG.

【0011】図1乃至図4に示す如く、本実施例の医療
用容器1は、輸液3を排出するための連通針11の刺通
が可能なプラスチック製容器壁2Aを有し、連通針11
の刺通可能な面積を有し、刺通された連通針11の外周
壁を弾性力を介して圧迫して刺通孔5Aを液密に維持し
うるゴム部材5(弾性部材)と、ゴム部材5を容器壁2
Aに止め置き、かつ容器壁2Aと弾性部材5との間を液
密にして容器壁2Aに取付られる止め材6とからなる排
出口4を有する。
As shown in FIGS. 1 to 4, the medical container 1 of this embodiment has a plastic container wall 2A through which a communicating needle 11 for discharging an infusion solution 3 can be pierced.
A rubber member 5 (elastic member) having an area capable of being pierced and capable of maintaining the piercing hole 5A liquid-tight by pressing the outer peripheral wall of the pierced communication needle 11 through elastic force; Member 5 to container wall 2
It has a discharge port 4 which is fixed to A and is made liquid-tight between the container wall 2A and the elastic member 5 and is attached to the container wall 2A.

【0012】本実施例に係る医療用容器1を更に詳しく
説明すると、容器1は、非定容積性の樹脂容器からな
る。具体的に、容器1はインフレーション成形した直鎖
状低密度ポリエチレンからなる。即ち、チューブ状シー
トが所定の大きさに裁断され、裁断されたシートの周縁
が互いに熱溶着シールされて容器1が形成される。シー
トの厚み、即ち容器壁2の厚みは200μmに成形さ
れ、容器壁2は可撓性を有し図4に示す連通針11など
の刺針部等により容易に刺通される。また、容器1には
熱溶着シールの際に、所定量の輸液3が無菌的に充填さ
れる。
The medical container 1 according to this embodiment will be described in more detail. The container 1 is made of a non-constant volume resin container. Specifically, the container 1 is made of inflation-molded linear low-density polyethylene. That is, the tubular sheet is cut into a predetermined size, and the peripheral edges of the cut sheets are heat-sealed to each other to form the container 1. The thickness of the sheet, that is, the thickness of the container wall 2 is formed to 200 μm, and the container wall 2 has flexibility and can be easily pierced by the piercing part such as the communicating needle 11 shown in FIG. Further, the container 1 is aseptically filled with a predetermined amount of the infusion solution 3 at the time of heat-sealing.

【0013】排出口4は、容器1の周縁シール部の近傍
に取付られ、ゴム部材5と止め材6からなる。図2〜図
4に示す如くゴム部材5は合成ゴムからなり、扁平なボ
タン状の成形物に形成される。ゴム部材5は、その扁平
面から連通針11の刺通が可能になっており、刺通後に
連通針11の外周縁をその弾性力で圧迫し、刺通孔5A
が液密に維持される。止め材6は、ポリエチレンの樹脂
成形物からなり、容器壁2に貼着する薄肉フランジ部6
A、ゴム部材5の収容部6B、及び筒状部6Cが形成さ
れる。
The discharge port 4 is attached in the vicinity of the peripheral seal portion of the container 1 and is composed of a rubber member 5 and a stopper 6. As shown in FIGS. 2 to 4, the rubber member 5 is made of synthetic rubber and is formed into a flat button-shaped molded product. The rubber member 5 allows the communicating needle 11 to be pierced through the flat surface thereof, and after the piercing, the outer peripheral edge of the communicating needle 11 is pressed by its elastic force, and the piercing hole 5A is formed.
Is kept liquid tight. The stopper 6 is made of a polyethylene resin molding, and is a thin flange portion 6 attached to the container wall 2.
A, a housing portion 6B of the rubber member 5, and a tubular portion 6C are formed.

【0014】ゴム部材5及び止め材6は十分に洗浄さ
れ、止め材6の収容部6Bにはゴム部材5が一時変形さ
れて無理やりに収容される。止め材6の薄肉フランジ部
6Aの貼着面に接着剤が塗布され、止め材6は薄肉フラ
ンジ部6Aを介して容器壁2に取付けられる。従って、
刺通孔5Aができるゴム部材5の一の面で覆われる外壁
2Aは、フランジ部6A面が接着剤を介して固着され外
壁2Aに刺通孔が生じても外部と液密性が維持される。
接着剤には、ポリエチレン−酢酸ビニル系の樹脂が使用
され、輸液に影響を与えないものが用いられる。接着方
法としては、例えば、図3に示すごとく、液止めロール
9、9で扁平にした容器壁2A及びフランジ部6Aを1
10℃付近でプレヒートしておき、そこに、110℃で
溶融可能なポリエチレン−酢酸ビニル系のホットメルト
接着剤を塗布し、両者を挟持治具を介して液密に固着さ
せる。止め材6の筒状部6Cはその開口端に無菌維持シ
ール7が貼着され、無菌維持シール7は蒸気透過性のフ
ィルムからなる。従って、連通針11が刺通されるゴム
部材5の刺通面を覆い無菌性を維持することができる。
また、容器1の周縁シール部には、把持部材8が取付ら
れ、図3及び図4に示す如く把持部材8には筒状部6C
が係止される。医療用容器1は高圧蒸気滅菌され、かか
る高圧蒸気滅菌により輸液3及び排出口4の筒状部6C
内も滅菌される。高圧蒸気滅菌は、日本薬局方の高圧蒸
気滅菌方法に基づいて行われ、高圧蒸気滅菌には一般的
なオートクレーブが使用され、オートクレーブ内は、例
えば、不活性ガスで置換した後に100乃至130℃の
温度で行う。
The rubber member 5 and the stopper member 6 are thoroughly washed, and the rubber member 5 is temporarily deformed and forcibly accommodated in the accommodating portion 6B of the stopper member 6. An adhesive is applied to the sticking surface of the thin flange portion 6A of the stopper 6, and the stopper 6 is attached to the container wall 2 via the thin flange 6A. Therefore,
The outer wall 2A covered with one surface of the rubber member 5 having the piercing hole 5A maintains liquid tightness to the outside even if the piercing hole is formed in the outer wall 2A by fixing the surface of the flange portion 6A with an adhesive. It
As the adhesive, a polyethylene-vinyl acetate resin is used, which does not affect the infusion. As an adhesion method, for example, as shown in FIG. 3, the container wall 2A and the flange portion 6A flattened by the liquid stopping rolls 9 and 1 are
It is preheated at about 10 ° C., a polyethylene-vinyl acetate-based hot melt adhesive that can be melted at 110 ° C. is applied thereto, and both are fixed in a liquid-tight manner via a holding jig. A sterility maintaining seal 7 is attached to the open end of the tubular portion 6C of the stopper 6, and the sterility maintaining seal 7 is made of a vapor permeable film. Therefore, the piercing surface of the rubber member 5 through which the communication needle 11 is pierced can be covered to maintain sterility.
Further, a gripping member 8 is attached to the peripheral edge seal portion of the container 1, and a cylindrical portion 6C is attached to the gripping member 8 as shown in FIGS. 3 and 4.
Is locked. The medical container 1 is subjected to high-pressure steam sterilization, and by such high-pressure steam sterilization, the infusion solution 3 and the tubular portion 6C of the discharge port 4 are
The inside is also sterilized. High-pressure steam sterilization is performed based on the high-pressure steam sterilization method of the Japanese Pharmacopoeia, a general autoclave is used for high-pressure steam sterilization, and the inside of the autoclave is, for example, 100 to 130 ° C. after being replaced with an inert gas. Do at temperature.

【0015】このように構成された実施例の医療用容器
1においては、その製造においては排出口4を取付ける
前に、容器1に輸液3を充填して液密にシールすること
ができる。そして、この場合、従来のように筒状の排出
口部材のようなものを挟んで熱溶着シールをする必要が
ないため、極めて簡単かつ無菌的に充填シールができ
る。また、排出口4は各部材の組立後に容器1に簡単に
取付けることができる。このため、排出口4の清浄処理
後は、できる限り人の手が入らないで清潔に維持され
る。医療溶容器1の保存時にあっては、弾性部材である
ゴム部材5などが輸液3と接触していないため、ゴム部
材5からの溶出物等を殆ど考慮しなくてよい。このた
め、弾性復元力の機能が極めて高い弾性部材の選択が可
能となり、液密性の維持を高めることができる。
In the medical container 1 of the embodiment having the above-described structure, in the manufacture thereof, the container 1 can be filled with the infusion solution 3 and sealed in a liquid-tight manner before the discharge port 4 is attached. Further, in this case, since it is not necessary to sandwich and seal a tubular discharge port member as in the conventional case, it is possible to extremely simply and aseptically fill and seal. Further, the discharge port 4 can be easily attached to the container 1 after assembling each member. Therefore, after the cleaning process of the discharge port 4, it is kept as clean as possible without human intervention. When the medical melting container 1 is stored, since the rubber member 5 or the like, which is an elastic member, is not in contact with the infusion solution 3, it is not necessary to consider the substance eluted from the rubber member 5 or the like. Therefore, it is possible to select an elastic member having an extremely high elastic restoring force function, and it is possible to enhance the maintenance of liquid tightness.

【0016】医療用容器1を使用する場合、図3及び図
4に示すごとく、先ず、排出口4の止め材の筒状部6C
を周縁シール部の把持部材8に把持させる。これによ
り、容器1は歪み、その容器1内に空隙が生じ、かかる
空隙部1Aに連通針11の先端を収容保持することが可
能となる。次に、無菌維持シール7を筒状部6Cから剥
離し、点滴用の連通針11をゴム部材6に刺通する。こ
れにより、容器1内の輸液3は連通針11を介して患者
へと流入される。この場合、連通針11はゴム部材5へ
の刺通が可能であり、容器1の外壁2Aは連通針11が
刺通する柔軟なシートであるため、連通針11をゴム部
材5及び外壁2Aに容易に貫通させることができる。そ
して、ゴム部材5を外壁2A面に液密に止め置いている
ため、破封された容器壁2Aの刺通孔から輸液3がゴム
部材5と容器1の外壁2との間を伝って外部にでること
がない。また、刺通されたゴム部材5の刺通孔5Aは、
その弾性力により連通針11の外周縁を液密に押圧して
いる。このため、ゴム部材5と容器1の外壁2との間に
出た輸液3が刺通孔5Aの隙間から流れ出ることがな
い。従って、従来と同様に外部との液密性が維持され
る。
When the medical container 1 is used, as shown in FIGS. 3 and 4, first, the tubular portion 6C of the stopper for the discharge port 4 is formed.
Is gripped by the gripping member 8 of the peripheral seal portion. As a result, the container 1 is distorted and a void is generated in the container 1, and the tip of the communication needle 11 can be accommodated and held in the void 1A. Next, the sterility maintaining seal 7 is peeled off from the tubular portion 6C, and the drip communicating needle 11 is pierced through the rubber member 6. As a result, the infusion solution 3 in the container 1 flows into the patient via the communication needle 11. In this case, since the communicating needle 11 can pierce the rubber member 5 and the outer wall 2A of the container 1 is a flexible sheet through which the communicating needle 11 pierces, the communicating needle 11 can be attached to the rubber member 5 and the outer wall 2A. It can be easily penetrated. Since the rubber member 5 is kept liquid-tight on the outer wall 2A surface, the infusion solution 3 travels between the rubber member 5 and the outer wall 2 of the container 1 from the pierced hole of the container wall 2A that has been ruptured. I never go out. The piercing hole 5A of the pierced rubber member 5 is
The elastic force presses the outer peripheral edge of the communication needle 11 in a liquid-tight manner. Therefore, the infusion solution 3 that has flowed out between the rubber member 5 and the outer wall 2 of the container 1 does not flow out from the gap of the piercing hole 5A. Therefore, the liquid tightness with the outside is maintained as in the conventional case.

【0017】上記実施例では、排出口4の止め材6に筒
状部6Cを形成し、筒状部6Cを把持部材8に止めて操
作性を高めたが、本発明では必ずしも止め材6に筒状部
6Cを設ける必要はない。また、筒状部6Cがなけれ
ば、無菌維持シール7を直接ゴム部材5の外面を覆って
貼着しても良い。上記実施例では、容器1の素材に直鎖
状低密度ポリエチレンのシートを用いたが、本発明では
これに限る必要はなく、上述した従来技術のそれ自体公
知の樹脂を使用しても良い。但し、医療用容器に用いる
ため、輸液3に悪影響を与えないオレフィン系の樹脂を
用いることが望ましい。また、排出口4の止め材のフラ
ンジ部6Aとの接着性等を高めるために、シートは異な
る樹脂を多層に積層して機能性を持たせても良い。上記
実施例では、インフレーション成形物を用いたが、本発
明ではこれに限るものではなく、その他の公知の成形シ
ート又はフィルム等を用いることができる。上記実施例
では、弾性部材としてのゴム部材5に合成ゴムを用いた
が、本発明では、これに限ることはなく、連通針の刺通
孔を液密にする弾性復元機能を有する限りその他の弾性
部材を使用することができる。例えば、熱可塑性エラス
トマーや天然ゴム等の使用もできる。上記輸液3には、
通常の輸液製剤の他に、高カロリー輸液剤や抗生物質等
の薬剤の溶解液であっても良い。上記実施例では、排出
口4を高圧蒸気滅菌する前に取り付けたが、排出口4を
組立後単独でガス滅菌処理等して無菌的に容器壁2に取
り付けても良い。この場合、排出口4の各部材は高圧蒸
気滅菌に耐えうる耐熱性を有する必要はない。
In the above embodiment, the tubular portion 6C is formed on the stopper 6 of the discharge port 4 and the tubular portion 6C is fixed to the grip member 8 to improve the operability. However, in the present invention, the stopper 6 is not always required. It is not necessary to provide the tubular portion 6C. If the tubular portion 6C does not exist, the sterility maintaining seal 7 may be directly attached to cover the outer surface of the rubber member 5. Although the linear low-density polyethylene sheet is used as the material of the container 1 in the above-mentioned embodiment, the present invention is not limited to this, and the above-mentioned conventional resin known per se may be used. However, since it is used as a medical container, it is desirable to use an olefin resin that does not adversely affect the infusion solution 3. Further, in order to improve the adhesiveness of the stopper of the discharge port 4 to the flange portion 6A, the sheet may be laminated with different resins in multiple layers to provide functionality. Although the inflation molded product is used in the above-mentioned examples, the present invention is not limited to this, and other known molded sheets or films can be used. In the above embodiment, synthetic rubber was used for the rubber member 5 as an elastic member, but the present invention is not limited to this, and other materials may be used as long as they have an elastic restoring function of making the piercing hole of the communicating needle liquid-tight. Elastic members can be used. For example, a thermoplastic elastomer or natural rubber can be used. The above infusion solution 3 includes
In addition to the usual infusion preparation, it may be a solution containing a high-calorie infusion or a drug such as an antibiotic. In the above embodiment, the discharge port 4 was attached before high-pressure steam sterilization, but the discharge port 4 may be attached to the container wall 2 aseptically after the assembly by gas sterilization treatment alone. In this case, each member of the discharge port 4 does not need to have heat resistance that can withstand high-pressure steam sterilization.

【0018】図5(A)及び(B)は、本発明に係る医
療用容器の第二実施例の要部を示す断面図、図6は、第
二実施例の医療用容器の使用時の要部を示す断面図であ
る。図5及び図6に示す医療用容器21は、容器の素材
が第一実施例と同様な素材が使用される。従って、容器
壁は同一の符号を付してその詳しい説明は省略する。
FIGS. 5 (A) and 5 (B) are sectional views showing the essential parts of a second embodiment of the medical container according to the present invention, and FIG. 6 is a view showing the medical container of the second embodiment when in use. It is sectional drawing which shows a principal part. The medical container 21 shown in FIGS. 5 and 6 uses the same material as that of the first embodiment. Therefore, the same reference numerals are given to the container walls, and detailed description thereof will be omitted.

【0019】図5及び図6に示す如く、医療用容器21
の排出口22は、ゴム部材23、止め材24の他に、貼
着材25、筒部材26、連通針27及び無菌維持シール
28とからなる。止め材24は貼着材25を介して外壁
2Aに液密に取付けられ、貼着材25は、ゴム部材23
の一の面を液密に覆っている。また止め材24は、筒部
材26が別体として取付られ、筒部材26は容器1の周
縁シール部21Bに係止部29を介して係止される。そ
して、筒部材26には指掛け部30が形成される。また
筒部材23内は滅菌されて無菌維持される無菌収容部3
1として形成され、無菌収容部31に連通針27が収容
されている。更に、連通針27は、刺針部材32と管部
材33とからなっている。
As shown in FIGS. 5 and 6, the medical container 21
In addition to the rubber member 23 and the stopper member 24, the discharge port 22 includes an adhesive member 25, a cylindrical member 26, a communication needle 27, and a sterility maintaining seal 28. The stopper material 24 is liquid-tightly attached to the outer wall 2A via the adhesive material 25, and the adhesive material 25 is the rubber member 23.
One side is covered liquid-tightly. The stopper 24 is attached to the tubular member 26 as a separate body, and the tubular member 26 is locked to the peripheral edge seal portion 21B of the container 1 via the locking portion 29. A finger hook 30 is formed on the tubular member 26. Further, the inside of the cylindrical member 23 is sterilized and the aseptic container 3 is maintained aseptically.
The communication needle 27 is housed in the sterile container 31. Further, the communication needle 27 includes a needle member 32 and a tube member 33.

【0020】本実施例に係る医療用容器21を更に説明
すると、図5に示す如く、ゴム部材23は上面に取付穴
が形成され、取付穴は連通針27の刺針部材32及び管
部材33の先端部が挿入される。またゴム部材23は止
め材24と貼着材25との間に液密に止め置かれ、止め
材24は貼着材25と超音波溶着により固着されてい
る。従って、ゴム部材23の一面が貼着材25により液
密に覆われている。止め材24の小径な接続部24Aに
は筒部材26の接続部26Aが液密に嵌着され、筒部材
26には連通針27の全体が収容される。筒部材26の
上部開口部26Bには指掛け部30、30が形成される
と共に、その開口面には無菌維持シール28が剥離可能
に貼着される。無菌維持シール28はガス透過性であ
り、エチレンオキサイドガス等の滅菌ガスの透過が可能
な公知の部材で形成される。このため、組立後の排出口
22をエチレンオキサイドガス滅菌処理すると、筒部材
26内は無菌が維持される無菌収容部31として形成さ
れる。
The medical container 21 according to this embodiment will be further described. As shown in FIG. 5, the rubber member 23 has a mounting hole formed on the upper surface thereof, and the mounting hole is formed by the needle member 32 of the communicating needle 27 and the tube member 33. The tip is inserted. The rubber member 23 is placed in a liquid-tight manner between the stopper 24 and the adhesive 25, and the stopper 24 is fixed to the adhesive 25 by ultrasonic welding. Therefore, one surface of the rubber member 23 is liquid-tightly covered with the adhesive material 25. The connecting portion 26A of the tubular member 26 is liquid-tightly fitted to the small-diameter connecting portion 24A of the stopper 24, and the entire communicating needle 27 is housed in the tubular member 26. Finger hooks 30, 30 are formed in the upper opening 26B of the tubular member 26, and a sterility maintaining seal 28 is releasably attached to the opening. The sterility maintaining seal 28 is gas permeable and is formed of a known member that is permeable to a sterilizing gas such as ethylene oxide gas. Therefore, when the exhaust port 22 after assembly is sterilized by ethylene oxide gas, the inside of the tubular member 26 is formed as a sterile container 31 in which sterility is maintained.

【0021】連通針27は無菌収容部31に収容され、
刺針部材32と管部材33とが別体となった樹脂成形物
から形成される。刺針部材32の先端は鋭角に形成さ
れ、ゴム部材23及び容器壁2の刺通が可能な状態にな
っており、また、その基端部は管部材33の中空路内に
遊嵌挿入可能に形成される。従って、刺針部材32は管
部材33から容易に脱抜される。管部材33の先端部の
径は刺針部材32の最大膨張径部の径より小さく形成さ
れ、管部材33の先端端面はかかる膨張径部内に治ま
り、連通針27の刺通時に図5の矢印Aの方向に移動し
てもゴム部材24から直接抵抗を受けないようになって
いる。管部材33の中間部には案内盤34が取付られ、
案内盤34の周縁は筒部材26の内壁面に摺接し連通針
27が矢印Aの方向に沿って移動するように案内してい
る。また、筒部材33の基端部は、末広がりに形成さ
れ、点滴用の接続アダプター41の接続が可能となって
いる。
The communication needle 27 is housed in the sterile container 31,
The puncture member 32 and the tube member 33 are formed from a resin molded product that is a separate body. The tip of the puncture member 32 is formed into an acute angle so that the rubber member 23 and the container wall 2 can be pierced, and the base end of the puncture member 32 can be loosely inserted into the hollow passage of the tube member 33. It is formed. Therefore, the needle member 32 is easily removed from the tube member 33. The diameter of the distal end portion of the tube member 33 is formed to be smaller than the diameter of the maximum expanded diameter portion of the needle member 32, and the distal end surface of the tube member 33 is settled within the expanded diameter portion, and when the communicating needle 27 is inserted, the arrow A in FIG. Even if the rubber member 24 moves in the direction of, the rubber member 24 does not directly receive resistance. A guide panel 34 is attached to the middle portion of the pipe member 33,
The peripheral edge of the guide panel 34 is in sliding contact with the inner wall surface of the tubular member 26 and guides the communication needle 27 so as to move in the direction of arrow A. Further, the base end portion of the cylindrical member 33 is formed in a divergent shape so that the connection adapter 41 for drip can be connected.

【0022】排出口22は上述のように組立後、エチレ
ンオキサイドガス滅菌処理され、図5(A)に示す如
く、液止めロール9、9で扁平にした容器壁2Aに配さ
れる。尚、容器21内の輸液3は既に高圧蒸気滅菌がな
されている。貼着材25面と容器壁2A面とは熱溶着さ
れ、互いに液密に固着される。この場合、かかる熱溶着
温度は、容器形成時の周縁シール部21Bの形成温度よ
り低くして、容器壁2Aのシート同士が完全熱溶着しな
いようにされる。
After being assembled as described above, the discharge port 22 is sterilized by ethylene oxide gas, and as shown in FIG. 5 (A), the discharge port 22 is arranged on the container wall 2A flattened by the liquid stopper rolls 9, 9. The infusion solution 3 in the container 21 has already been subjected to high-pressure steam sterilization. The surface of the adhesive material 25 and the surface of the container wall 2A are heat-welded and liquid-tightly fixed to each other. In this case, the heat welding temperature is lower than the forming temperature of the peripheral edge seal portion 21B when the container is formed so that the sheets of the container wall 2A are not completely heat welded.

【0023】図5(B)に示す如く、排出口22が容器
壁2Aに取付られた後に、容器壁2Aごしに電子線照射
滅菌により、接着部を滅菌する。このような電子線を照
射すると、電子線は容器壁2Aが肉薄であると、内部を
通して接着部を直接照射する。この場合、接着部の照射
量が1.6Mrad以上であれば十分な滅菌ができる。
例えば、微生物の放射線菌(指標菌:B.pumilus(spor
es)E−601)で約0.2MradのD値を有する。
容器内は清潔に維持されて薬剤が充填され、通常100
オーダー以下の菌が付着している。また安全性を十分に
考慮すれば、102オーダーまでの付着があるとすれ
ば、滅菌保証レベルが10-6%の生存率であることか
ら、0.2Mrad×8以上での照射が必要となる。
As shown in FIG. 5B, after the discharge port 22 is attached to the container wall 2A, the adhesive portion is sterilized by electron beam irradiation sterilization through the container wall 2A. When such an electron beam is irradiated, the electron beam directly irradiates the adhesive portion through the inside when the container wall 2A is thin. In this case, sufficient sterilization can be performed if the irradiation amount of the adhesive portion is 1.6 Mrad or more.
For example, microbial radiation bacteria (indicator bacteria: B. pumilus (spor
es) E-601) with a D value of about 0.2 Mrad.
The inside of the container is kept clean and filled with the drug, usually 10 0
Bacteria below the order are attached. In addition, if the adhesion is up to the order of 10 2 in consideration of safety, it is necessary to irradiate at 0.2 Mrad × 8 or more because the sterilization assurance level is a survival rate of 10 −6 %. Become.

【0024】電子線の透過性は、電子の加速電圧により
決定され、高エネルギー型の電子線照射装置では最高1
3000g/m2であり、これは水(比重1g/m3)の
厚みで13000μmである。しかし、高エネルギー型
の電子線照射装置は、X線等の発生が大きく、その遮蔽
設備が過大となり、また容器にも影響を与える場合があ
る。このため、高エネルギー型の電子線照射装置では生
産ラインを組むことが艱難になる。一方、中低エネルギ
ー型の1MeV以下のものでは、1500g/m2程度
までの電子線の透過性が期待される。このため、薬剤の
電子線照射滅菌においては、両面を照射するとして、容
器壁2Aの肉厚が(1600/2)μm以下であれば、
低中エネルギー型の設備がコンパクトなものの使用が可
能となり、生産ライン上、薬剤を大量にかつ確実に滅菌
することが可能である。従って、本実施例では、容器壁
2Aの肉厚が200μmであるため、低エネルギー型の
電子線照射装置により接着部に直接電子線滅菌がなされ
る。
The electron beam permeability is determined by the acceleration voltage of the electrons, and is 1 at the maximum in the high energy type electron beam irradiation apparatus.
It is 3000 g / m 2 , which is 13000 μm in thickness of water (specific gravity 1 g / m 3 ). However, in the high energy type electron beam irradiation apparatus, generation of X-rays and the like is large, the shielding facility therefor becomes excessive, and the container may be affected. Therefore, it is difficult to assemble a production line with a high-energy electron beam irradiation apparatus. On the other hand, in the medium and low energy type of 1 MeV or less, the electron beam permeability of up to about 1500 g / m 2 is expected. Therefore, in electron beam irradiation sterilization of a drug, if both sides are irradiated and the wall thickness of the container wall 2A is (1600/2) μm or less,
It is possible to use compact low-medium energy type equipment, and it is possible to sterilize a large amount of chemicals reliably on the production line. Therefore, in this embodiment, since the wall thickness of the container wall 2A is 200 μm, the low energy type electron beam irradiation device directly sterilizes the bonded portion with the electron beam.

【0025】このように構成された医療用容器21を使
用する場合、無菌維持シール28が筒部材26から剥離
され、点滴用の連結アダプター41が連通針27の基端
開口に接続される。そして、連結アダプター41と共に
連結針27が筒部材26内を移動させられ、連通針27
の刺針部材32によって、ゴム部材23及び容器壁2A
が刺通される。そして、管部材33の先端は刺針部材3
2に案内されて容器21内に位置する。また、刺針部材
32は脱抜可能であるため、逆さにすれば容易に管部材
33から離れる。これにより、図6に示す如く容器21
内と連結アダプター41が連通され、点滴が可能とな
る。
When using the medical container 21 having the above-described structure, the sterility maintaining seal 28 is peeled from the tubular member 26, and the drip connection adapter 41 is connected to the proximal end opening of the communication needle 27. Then, the connecting needle 27 is moved in the tubular member 26 together with the connecting adapter 41, and the connecting needle 27
The needle member 32 of the rubber member 23 and the container wall 2A.
Is pierced. The tip of the tube member 33 is attached to the needle member 3
It is located in the container 21 guided by 2. Further, since the puncture member 32 can be removed, it can be easily separated from the tube member 33 by inverting it. As a result, as shown in FIG.
The inside is connected to the connection adapter 41 to enable infusion.

【0026】この場合、筒部材26に形成された指掛け
部30により、連通針27の刺通操作が容易となり、ま
た、無菌維持シール28が筒部材26の開口を液密に閉
じ、無菌収容部31が形成され、かかる収容部31に連
通針27が収容されるため、無菌的な操作が更に可能と
なる。また、無菌維持シール28の剥離後も連通針27
の刺針部材32及び管部材33の先端部はゴム部材23
の取付穴内にあり、外気と接触がない。このため、一連
の操作を無菌的に行うことができる。また、連通針27
の刺通後は、刺針部材32が脱抜するため、他の容器壁
2に刺針して容器自体を破封するおそれがない。更に、
容器21の組立においては、排出口22のみを容器本体
とは別に滅菌することができるため、必ずしも高圧蒸気
滅菌とすることはなく、またその接続部は、電子線照射
による滅菌処理により、確実な滅菌が簡単にできる。上
記実施例では、貼着材25でゴム部材23の全面を覆っ
たが、連通針27が刺通する部分に孔等を設けてゴム部
材23面の一部を覆うようにしても良い。上記実施例で
電子線照射により、容器と排出口との接続部の滅菌をし
たが、かかる滅菌を第一実施例の容器に適用しても良
い。
In this case, the finger hooking portion 30 formed on the tubular member 26 facilitates the piercing operation of the communication needle 27, and the sterility maintaining seal 28 liquid-tightly closes the opening of the tubular member 26, so that the aseptic container is provided. 31 is formed and the communication needle 27 is accommodated in the accommodating portion 31, so that aseptic operation can be further performed. In addition, the communication needle 27 is used even after the sterility maintaining seal 28 is peeled off.
The tips of the needle member 32 and the tube member 33 of the rubber member 23
It is in the mounting hole of and there is no contact with the outside air. Therefore, a series of operations can be performed aseptically. In addition, the communication needle 27
After the piercing, the piercing member 32 is removed, so there is no risk of piercing the other container wall 2 and breaking the container itself. Furthermore,
When assembling the container 21, only the discharge port 22 can be sterilized separately from the container body, and therefore high pressure steam sterilization is not always required, and the connecting portion is securely sterilized by electron beam irradiation. Easy sterilization. In the above-described embodiment, the entire surface of the rubber member 23 is covered with the adhesive material 25, but a hole or the like may be provided in the portion through which the communication needle 27 penetrates to cover a part of the surface of the rubber member 23. Although the connection between the container and the outlet is sterilized by electron beam irradiation in the above-mentioned embodiment, such sterilization may be applied to the container of the first embodiment.

【0027】図7は、本発明に係る医療用容器の第三実
施例の要部断面図である。第三実施例の医療用容器51
は、第二実施例の医療用容器21とほぼ同様な構成にな
っており、ほぼ同様な構成及び部材については第二実施
例の医療用容器21と同一の符号を付してその詳しい説
明を省略する。図7に示す如く、本実施例の医療用容器
51が第二実施例のものと異なる点は、筒部材26内に
設けられる連通手段が異なることである。
FIG. 7 is a sectional view of the essential parts of a third embodiment of the medical container according to the present invention. Medical container 51 of the third embodiment
Has almost the same configuration as the medical container 21 of the second embodiment, and about the same configuration and members are given the same reference numerals as those of the medical container 21 of the second embodiment, and detailed description thereof will be given. Omit it. As shown in FIG. 7, the medical container 51 of this embodiment is different from that of the second embodiment in that the communication means provided in the tubular member 26 is different.

【0028】排出口52の筒部材26内には、刺針部材
32の他に、小径な先端部に刺針部材32が設けられ、
基端の大径部にゴム栓体54が取付られる連結筒53が
移動可能に設けられる。ゴム栓体54は止め材55を介
して連結筒53の基端開口を密封して取り付けられ、止
め材55には無菌維持シール56が剥離可能に設けられ
てゴム栓体54の外表面を覆っている。また、筒部材2
6と連結筒53との間には可撓性の筒状シール材56が
設けられ、シール材は筒状材26内を液密に保ってい
る。そして、このような排出口52は第二実施例の排出
口22と同様に組立後に滅菌され、容器壁2に取付られ
る。
In the cylindrical member 26 of the discharge port 52, in addition to the puncture member 32, the puncture member 32 is provided at the tip portion having a small diameter.
A connecting cylinder 53, to which a rubber plug 54 is attached, is movably provided at the large diameter portion of the base end. The rubber stopper 54 is attached by sealing the base end opening of the connecting cylinder 53 via a stopper 55, and a sterile maintenance seal 56 is detachably provided on the stopper 55 to cover the outer surface of the rubber stopper 54. ing. In addition, the tubular member 2
A flexible tubular seal member 56 is provided between the connection member 6 and the connecting tube 53, and the seal member keeps the inside of the tubular member 26 liquid-tight. Then, like the discharge port 22 of the second embodiment, such a discharge port 52 is sterilized after assembly and attached to the container wall 2.

【0029】このように構成された医療用容器51にあ
っては、使用時、先ず、連結筒53を移動させて、刺針
部材32でゴム部材23、貼着材25及び容器壁2Aを
刺通する。これにより、連結筒53内と容器51内とを
連通させ、その後、無菌維持シール57を剥離し、点滴
用連結針等をゴム栓体54に刺通して、点滴を開始する
ことができる。従って、排出口52を組立てた後に、容
器51に取り付けることができ、また容器51内の輸液
と弾性部材であるゴム栓等を接触させて保存することが
ないため、ゴム栓体からの溶出物の虞が一掃される。
In use of the medical container 51 having such a structure, first, the connecting cylinder 53 is moved so that the needle member 32 pierces the rubber member 23, the adhesive material 25 and the container wall 2A. To do. As a result, the inside of the connecting cylinder 53 and the inside of the container 51 are made to communicate with each other, then the sterility maintaining seal 57 is peeled off, and the drip connecting needle or the like is pierced into the rubber stopper 54 to start drip. Therefore, after the discharge port 52 is assembled, it can be attached to the container 51, and since the infusion solution in the container 51 and the rubber stopper or the like that is an elastic member are not brought into contact with each other to be stored, the eluate from the rubber stopper is not stored. The fear of is wiped out.

【0030】[0030]

【発明の効果】以上説明したように本発明の医療用容器
は、液を排出するための連通針の刺通が可能なプラスチ
ック製容器壁を有し、上記連通針の刺通可能な面積を有
し、刺通された連通針の外周壁を弾性力を介して圧迫し
て刺通孔を液密に維持しうる弾性部材と、上記弾性部材
を上記容器壁に止め置き、かつ上記容器壁と上記弾性部
材との間を液密にして上記容器壁に取付られる止め材と
からなる排出口を有するので、容器への取付が簡単で、
容器の高圧蒸気滅菌後も簡単取り付けることができる排
出口を具備し、製造上の安全性、経済性が極めて高いも
のとなる。
As described above, the medical container of the present invention has the plastic container wall through which the communicating needle for discharging the liquid can be pierced, and the piercing area of the communicating needle can be reduced. An elastic member having an outer peripheral wall of the pierced communication needle through an elastic force to maintain the piercing hole liquid-tight, and the elastic member being fixedly placed on the container wall, and the container wall Since it has a discharge port composed of a stopper that is liquid-tight between the elastic member and the elastic member and is attached to the container wall, it is easy to attach to the container,
Equipped with a discharge port that can be easily installed even after high-pressure steam sterilization of the container, the manufacturing safety and economy are extremely high.

【図面の簡単な説明】[Brief description of the drawings]

【図1】第一実施例における医療用容器の正面図であ
る。
FIG. 1 is a front view of a medical container according to a first embodiment.

【図2】(A)〜(D)は第一実施例における医療用容
器の排出口の断面図である。
2A to 2D are cross-sectional views of a discharge port of the medical container according to the first embodiment.

【図3】第一実施例における医療用容器の要部断面図で
ある。
FIG. 3 is a cross-sectional view of the main parts of the medical container according to the first embodiment.

【図4】第一実施例における医療用容器の使用時の要部
断面図である。
FIG. 4 is a cross-sectional view of essential parts when the medical container according to the first embodiment is used.

【図5】(A)及び(B)第二実施例における医療用容
器の排出口の要部断面図である。
5 (A) and 5 (B) are cross-sectional views of a main part of a discharge port of a medical container according to a second embodiment.

【図6】第二実施例における医療用容器の要部断面図で
ある。
FIG. 6 is a cross-sectional view of essential parts of a medical container according to a second embodiment.

【図7】第三実施例における医療用容器の要部断面図で
ある。
FIG. 7 is a cross-sectional view of essential parts of a medical container according to a third embodiment.

【符号の説明】[Explanation of symbols]

1、21、51 医療用容器 2 容器壁 2A 外壁 4、22、52 排出口 5 ゴム部材 6 止め材 7 無菌維持シール 8 把持部材 9 液止めローラ 11 連通針 1, 21, 51 Medical container 2 Container wall 2A Outer wall 4, 22, 52 Discharge port 5 Rubber member 6 Stopper 7 Aseptic maintenance seal 8 Grasping member 9 Liquid stop roller 11 Communication needle

Claims (9)

【特許請求の範囲】[Claims] 【請求項1】 液を排出するための連通針の刺通が可能
なプラスチック製容器壁を有し、上記連通針の刺通可能
な面積を有し、刺通された連通針の外周壁を弾性力を介
して圧迫して刺通孔を液密に維持しうる弾性部材と、上
記弾性部材を上記容器壁に止め置き、かつ上記容器壁と
上記弾性部材との間を液密にして上記容器壁に取付られ
る止め材とからなる排出口を有することを特徴とする医
療用容器。
1. A plastic container wall capable of piercing a communicating needle for discharging a liquid, having a pierceable area of the communicating needle, and providing a peripheral wall of the pierced communicating needle. An elastic member capable of maintaining a piercing hole in a liquid-tight state by pressing through an elastic force, the elastic member being fixedly placed on the container wall, and a space between the container wall and the elastic member being liquid-tight. A medical container having a discharge port formed of a stopper attached to a container wall.
【請求項2】 上記排出口の弾性部材には、上記弾性部
材の刺通孔の形成面を覆う無菌維持シール材が剥離可能
に取付られていることを特徴とする請求項1記載の医療
用容器。
2. The medical device according to claim 1, wherein an aseptic maintenance sealing material that covers a surface of the elastic member on which a puncture hole is formed is detachably attached to the elastic member of the discharge port. container.
【請求項3】 上記止め材は貼着材を介して上記外壁に
取付けられ、該貼着材は、上記弾性部材の上記一の面の
全部又は一部を覆っていることを特徴とする請求項1又
は2記載の医療用容器。
3. The adhesive material is attached to the outer wall via an adhesive material, and the adhesive material covers all or part of the one surface of the elastic member. Item 1. A medical container according to item 1 or 2.
【請求項4】 上記排出口の止め材には、筒部が一体又
は別体として取付られ、上記筒部は上記容器に係止され
ることを特徴とする請求項1〜3記載の医療用容器。
4. The medical device according to claim 1, wherein a tubular portion is integrally or separately attached to the stopper of the discharge port, and the tubular portion is locked to the container. container.
【請求項5】 上記筒部には指掛け部が形成されている
ことを特徴とする請求項4記載の医療用容器。
5. The medical container according to claim 4, wherein a finger hook portion is formed on the cylindrical portion.
【請求項6】 上記筒部内は滅菌されて無菌維持される
無菌収容部として形成され、上記筒部内に上記連通針が
収容されていることを特徴とする請求項4又は5記載の
医療用容器。
6. The medical container according to claim 4, wherein the inside of the cylindrical portion is formed as a sterile container that is sterilized and maintained aseptically, and the communication needle is accommodated in the cylindrical portion. .
【請求項7】 上記連通針は、刺針部と管部とが別体と
して形成され、刺通後に該刺針部が分離することを特徴
とする請求項6記載の医療用容器。
7. The medical container according to claim 6, wherein in the communication needle, the puncture portion and the tube portion are formed as separate bodies, and the puncture portion is separated after the puncture.
【請求項8】 上記管部は、上記刺針部が取り付けられ
る開口端の反対側の開口端に被刺通用弾性部材が設けら
れていることを特徴とする請求項7記載の医療用容器。
8. The medical container according to claim 7, wherein the tube portion is provided with an elastic member for piercing at an opening end opposite to an opening end to which the puncture portion is attached.
【請求項9】 上記請求項1〜2記載の医療用容器の製
造方法において、上記排出口と容器との接続部を電子線
照射により滅菌して製造することを特徴とする医療用容
器の製造方法。
9. The method for manufacturing a medical container according to any one of claims 1 and 2, wherein the connection between the outlet and the container is sterilized by electron beam irradiation. Method.
JP7293651A 1995-10-16 1995-10-16 Medical container and its manufacture Pending JPH09108301A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP7293651A JPH09108301A (en) 1995-10-16 1995-10-16 Medical container and its manufacture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP7293651A JPH09108301A (en) 1995-10-16 1995-10-16 Medical container and its manufacture

Publications (1)

Publication Number Publication Date
JPH09108301A true JPH09108301A (en) 1997-04-28

Family

ID=17797479

Family Applications (1)

Application Number Title Priority Date Filing Date
JP7293651A Pending JPH09108301A (en) 1995-10-16 1995-10-16 Medical container and its manufacture

Country Status (1)

Country Link
JP (1) JPH09108301A (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113397972A (en) * 2014-12-18 2021-09-17 株式会社大冢制药工厂 Port and liquid medicine bag
CN114250142A (en) * 2020-09-22 2022-03-29 湖南洪江嵩云禽业有限公司 Safety warning card for freshness of ice fresh poultry meat storage and transportation

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113397972A (en) * 2014-12-18 2021-09-17 株式会社大冢制药工厂 Port and liquid medicine bag
CN114250142A (en) * 2020-09-22 2022-03-29 湖南洪江嵩云禽业有限公司 Safety warning card for freshness of ice fresh poultry meat storage and transportation

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