JP4463205B2 - Medical multi-chamber container and manufacturing method thereof - Google Patents

Medical multi-chamber container and manufacturing method thereof Download PDF

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Publication number
JP4463205B2
JP4463205B2 JP2005510283A JP2005510283A JP4463205B2 JP 4463205 B2 JP4463205 B2 JP 4463205B2 JP 2005510283 A JP2005510283 A JP 2005510283A JP 2005510283 A JP2005510283 A JP 2005510283A JP 4463205 B2 JP4463205 B2 JP 4463205B2
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discharge
container
chamber
sealing
partition
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JP2006507914A (en
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勝美 長尾
浩一 久米
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Otsuka Pharmaceutical Co Ltd
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Otsuka Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093Containers having several compartments for products to be mixed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2024Separating means having peelable seals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/76Making non-permanent or releasable joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/10Particular design of joint configurations particular design of the joint cross-sections
    • B29C66/11Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112Single lapped joints
    • B29C66/1122Single lap to lap joints, i.e. overlap joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/21Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being formed by a single dot or dash or by several dots or dashes, i.e. spot joining or spot welding
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/244Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being non-straight, e.g. forming non-closed contours
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/05Particular design of joint configurations
    • B29C66/20Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines
    • B29C66/24Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight
    • B29C66/244Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being non-straight, e.g. forming non-closed contours
    • B29C66/2442Particular design of joint configurations particular design of the joint lines, e.g. of the weld lines said joint lines being closed or non-straight said joint lines being non-straight, e.g. forming non-closed contours in the form of a single arc of circle
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/345Progressively making the joint, e.g. starting from the middle
    • B29C66/3452Making complete joints by combining partial joints
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/346Making joints having variable thicknesses in the joint area, e.g. by using jaws having an adapted configuration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/346Making joints having variable thicknesses in the joint area, e.g. by using jaws having an adapted configuration
    • B29C66/3462Making joints having variable thicknesses in the joint area, e.g. by using jaws having an adapted configuration by differentially heating the zones of different thickness
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/01General aspects dealing with the joint area or with the area to be joined
    • B29C66/347General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients
    • B29C66/3472General aspects dealing with the joint area or with the area to be joined using particular temperature distributions or gradients; using particular heat distributions or gradients in the plane of the joint, e.g. along the joint line in the plane of the joint or perpendicular to the joint line in the plane of the joint
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/40General aspects of joining substantially flat articles, e.g. plates, sheets or web-like materials; Making flat seams in tubular or hollow articles; Joining single elements to substantially flat surfaces
    • B29C66/41Joining substantially flat articles ; Making flat seams in tubular or hollow articles
    • B29C66/43Joining a relatively small portion of the surface of said articles
    • B29C66/431Joining the articles to themselves
    • B29C66/4312Joining the articles to themselves for making flat seams in tubular or hollow articles, e.g. transversal seams
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/50General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/53Joining single elements to tubular articles, hollow articles or bars
    • B29C66/532Joining single elements to the wall of tubular articles, hollow articles or bars
    • B29C66/5326Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
    • B29C66/53261Enclosing tubular articles between substantially flat elements
    • B29C66/53262Enclosing spouts between the walls of bags, e.g. of medical bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/71General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/70General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/739General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/91Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/914Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux
    • B29C66/9141Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature
    • B29C66/91411Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux by controlling or regulating the temperature, the heat or the thermal flux by controlling or regulating the temperature of the parts to be joined, e.g. the joining process taking the temperature of the parts to be joined into account
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29CSHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00General aspects of processes or apparatus for joining preformed parts
    • B29C66/90Measuring or controlling the joining process
    • B29C66/92Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2009/00Layered products
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B29WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29LINDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00Other particular articles
    • B29L2031/712Containers; Packaging elements or accessories, Packages
    • B29L2031/7148Blood bags, medical bags

Description

本発明は、同時に配合すると経時変化を起こすような不安定な各種薬剤を個別に封入する複数の収納室を備え、各収納室間を仕切っている仕切り用封止部を開封することにより、各収納室内に封入されている薬剤を混合できる医療用複室容器及びその製造方法に関する。   The present invention comprises a plurality of storage chambers that individually enclose various unstable drugs that cause a change with time when blended at the same time, and by opening the partition sealing portions that partition the storage chambers, The present invention relates to a medical multi-chamber container capable of mixing a medicine enclosed in a storage chamber and a method for manufacturing the same.

この種の複室容器は、従来より種々のものが提案されているが、その代表的なものとして、容器をプラスチックフィルムにより袋状に形成した複室容器を挙げることができる。この容器では、プラスチックフィルムから構成されていることを利用して、対向するフィルム面を熱融着することにより、各収納室間を仕切る仕切り用弱シール部を形成している。   Various types of multi-chamber containers have been proposed in the past, and a typical example of such a multi-chamber container is a multi-chamber container in which the container is formed into a bag shape with a plastic film. In this container, the weak seal part for a partition which partitions off between each storage chamber is formed by heat-seal | fusing the film surface which opposes using the structure comprised from the plastic film.

このような複室容器は、薬液の混合操作を無菌的に行うことができ、安全性、衛生性に優れているというメリットがある一方、次のような問題があった。すなわち、仕切り用弱シール部を開封して薬液を混合する前に、薬剤排出部に導管を複室容器に接続すると、混合前の薬液が投与される可能性があった。   Such a multi-chamber container has the merit that the mixing operation of the chemical solution can be performed aseptically and is excellent in safety and hygiene, but has the following problems. That is, when the conduit is connected to the multi-chamber container before the partition weak seal portion is opened and the chemical solution is mixed, the chemical solution before mixing may be administered.

この問題を解決するため、例えば特開平9−327498号公報には、薬剤排出部と、これに隣接する収納室との間を仕切る排出用弱シール部を設けた医療用複室容器が開示されている。この複室容器によれば、仕切り用弱シール部を開封する前に誤って薬剤排出部に導管を接続した場合であっても、排出用弱シール部を開封しない限りは、薬剤排出部から薬液が排出されないようになっている。   In order to solve this problem, for example, Japanese Patent Application Laid-Open No. 9-327498 discloses a medical multi-chamber container provided with a weak discharge portion for discharge that partitions between a medicine discharge portion and a storage chamber adjacent thereto. ing. According to this multi-chamber container, even when a conduit is accidentally connected to the medicine discharge part before opening the weak seal part for partitioning, as long as the weak seal part for discharge is not opened, the drug solution is discharged from the drug discharge part. Is not discharged.

ところで、上記のような医療用複室容器は、製造工程の終盤に容器の加熱滅菌工程を経なければならないが、この工程は、排出用弱シール部の形成工程の前後いずれかに行われることが多い。すなわち、一般的には次に示す2つの方法のいずれかによる製造方法が採用される。第1の方法においては、各収納室に薬液を注入した後、排出用弱シール部を形成し、これに続いて容器を加熱滅菌する。第2の方法においては、薬液の充填後、容器を加熱滅菌し、その後に排出用弱シール部を形成する。
特開平9−327498号公報
By the way, the medical multi-chamber container as described above must undergo a heat sterilization process of the container at the end of the manufacturing process, and this process is performed either before or after the process of forming the weak seal portion for discharge. There are many. That is, generally, a manufacturing method using one of the following two methods is adopted. In the first method, a chemical solution is injected into each storage chamber, a weak seal portion for discharge is formed, and the container is subsequently heat sterilized. In the second method, after filling the chemical solution, the container is sterilized by heating, and then a weak seal portion for discharge is formed.
JP-A-9-327498

しかしながら、第1の方法では、排出部と排出用弱シール部との間に形成される中間室には薬液がほとんど存在しない。このために、加熱による蒸気が充分に発生せず、中間室における滅菌効果が十分に保証できないという問題がある。さらに、第1及び第2の方法に共通する問題として、これらの方法では、薬液を注入した後に排出用弱シール部を形成するため、中間室が形成される部分に少量の薬液が付着することがある。この状態で排出用弱シール部を形成すると、中間室に薬液が付着したまま製品が出荷されることになる。こうして出荷された製品を保管した場合、付着した薬液の水分がプラスチックフィルムを通して蒸散し、結晶が析出することがある。その後、この結晶が再溶解しないままで容器内に残留すると、この結晶が薬液ととともに患者に投与される可能性がある。   However, in the first method, there is almost no chemical solution in the intermediate chamber formed between the discharge part and the discharge weak seal part. For this reason, there is a problem that steam due to heating is not sufficiently generated and the sterilization effect in the intermediate chamber cannot be sufficiently ensured. Further, as a problem common to the first and second methods, in these methods, since a weak seal portion for discharge is formed after the chemical solution is injected, a small amount of the chemical solution adheres to the portion where the intermediate chamber is formed. There is. If the discharge weak seal portion is formed in this state, the product is shipped with the chemical solution attached to the intermediate chamber. When the product shipped in this way is stored, the water of the attached chemical solution may evaporate through the plastic film, and crystals may be deposited. Thereafter, if the crystals remain in the container without being redissolved, the crystals may be administered to the patient together with the drug solution.

ところで、上記複室容器では、弱シール部を開封する際に、容器を押圧することによって弱シール部に作用する圧力が、その中央付近に作用しやすい傾向にあり、中央付近のみが開封する一方、その両端部が未開封状態のままになるということがあった。   By the way, in the above-mentioned multi-chamber container, when opening the weak seal portion, the pressure acting on the weak seal portion by pressing the container tends to act near the center, while only the vicinity of the center is opened. In some cases, both end portions remain unopened.

このような状態が排出用弱シール部で発生すると、両端部の未開封部分が障壁になって薬剤排出部への薬液の流れが妨げられることになり、薬液をスムーズに投与できないという問題がある。特に、図12に示すように、排出用弱シール部51が、薬剤排出部53を取り囲むように円弧状に形成され、その両端部が容器の周縁部55に連結されている場合には、未開封部分51aが障壁になって容器の両側部付近の薬液が薬剤排出部53へ流れず、すべての薬液を適切に投与できないという問題がある。   When such a state occurs in the discharge weak seal portion, the unopened portions at both ends serve as a barrier and the flow of the chemical solution to the drug discharge portion is obstructed, and there is a problem that the drug solution cannot be administered smoothly. . In particular, as shown in FIG. 12, when the discharge weak seal portion 51 is formed in an arc shape so as to surround the medicine discharge portion 53 and both end portions thereof are connected to the peripheral edge portion 55 of the container, There is a problem in that the unsealed portion 51a becomes a barrier and the chemical solution near the both sides of the container does not flow to the drug discharge portion 53, so that all the chemical solutions cannot be appropriately administered.

本発明は、上記問題を解決するためになされたものであり、排出用弱シール部と薬剤排出部との間の中間室を十分に滅菌することができ、しかも、この中間室に薬液の結晶が残留するのを確実に防止することができる医療用複室容器及びその製造方法を提供することを第1の目的とする。また、本発明は、未開封部分を残さずに排出用封止部を開封することができ、容器内の薬液を確実に投与することができる医療用複室容器を提供することを第2の目的とする。   The present invention has been made to solve the above-described problem, and can sufficiently sterilize the intermediate chamber between the discharge weak seal portion and the drug discharge portion. It is a first object of the present invention to provide a medical multi-chamber container and a method for manufacturing the same that can reliably prevent the residue from remaining. The second aspect of the present invention is to provide a medical multi-chamber container that can open the discharge sealing portion without leaving an unopened portion and can reliably administer the chemical solution in the container. Objective.

本発明に係る第1の医療用複室容器は、上記問題を解決するためになされたものであり、薬剤を収納可能な複数の収納室及び前記各収納室間を仕切る仕切り用封止部を有する容器本体と、容器本体に取り付けられ前記収納室から薬剤を排出可能とする薬剤排出部とを備え、前記仕切り用封止部が、使用に際して前記各収納室を連通させるように開封可能に構成された医療用複室容器において、前記収納室の少なくとも1つに、液状の薬剤が封入されており、前記容器本体は、前記収納室と前記薬剤排出部との間を仕切り、使用に際して開封可能な排出用封止部を備え、これによって該排出用封止部と薬剤排出部との間に中間室が形成されており、前記複数の収納室のうち、少なくとも前記排出用封止部に接する収納室に、液状の薬剤が封入されており、前記排出用封止部には、前記収納室と中間室とを連通させる連通路が少なくとも1箇所に形成され、該連通路は、気体の通過を許容する一方、液体の通過を抑制するように構成されていることを特徴とする。   A first medical multi-chamber container according to the present invention is made to solve the above-described problem, and includes a plurality of storage chambers capable of storing a medicine and a partition sealing portion that partitions the storage chambers. A container main body and a medicine discharge portion attached to the container main body and capable of discharging the medicine from the storage chamber, and the partition sealing portion is configured to be openable so as to communicate with each of the storage chambers in use. In the medical multi-chamber container, a liquid medicine is sealed in at least one of the storage chambers, and the container body is partitioned between the storage chamber and the medicine discharge portion and can be opened for use. A discharge sealing portion, and an intermediate chamber is formed between the discharge sealing portion and the medicine discharge portion, and contacts at least the discharge sealing portion among the plurality of storage chambers. Liquid medicine is enclosed in the storage room The discharge sealing portion is formed with at least one communication passage that allows the storage chamber and the intermediate chamber to communicate with each other. The communication passage allows passage of gas while suppressing passage of liquid. It is comprised so that it may do.

この構成によれば、連通路を介して、収納室から蒸散する薬液の水分が中間室にも流入するため、中間室内が過度に乾燥するのを防止でき、例えば中間室内に付着した薬液から水分が蒸発して結晶が析出するのを防ぐことができる。その結果、薬液の結晶が患者に投与されるのを確実に防止することができる。   According to this configuration, since the moisture of the chemical liquid that evaporates from the storage chamber also flows into the intermediate chamber via the communication path, it is possible to prevent the intermediate chamber from being excessively dried, for example, from the chemical liquid that has adhered to the intermediate chamber. Can be prevented from evaporating and precipitating crystals. As a result, it is possible to reliably prevent the medicinal liquid crystals from being administered to the patient.

また、このような医療用複室容器は、製造工程において加熱滅菌されることが多いが、例えば容器本体の加熱滅菌が行われる前に、排出用封止部が形成される製造工程を経た場合であっても、中間室は収納室と連通しているため、収納室から流出した蒸気によって中間室内が十分に滅菌されるため、容器本体の内部全体を確実に滅菌することができる。   Also, such medical multi-chamber containers are often heat sterilized in the manufacturing process. For example, when the container main body is subjected to a manufacturing process in which a discharge sealing portion is formed before heat sterilization is performed. Even so, since the intermediate chamber communicates with the storage chamber, the intermediate chamber is sufficiently sterilized by the vapor flowing out of the storage chamber, so that the entire interior of the container body can be reliably sterilized.

上記医療用複室容器では、連通路の最も狭い部分の幅又は径を1〜5mmにすることが好ましく、これにより、収納室から中間室への薬液の自由な流入を確実に抑制することができる。したがって、連通路が形成されていても、使用前に収納室から薬剤排出部へ薬剤が即座に流出することが確実に防止できる。   In the medical multi-chamber container, the width or diameter of the narrowest portion of the communication path is preferably 1 to 5 mm, thereby reliably suppressing free inflow of the chemical solution from the storage chamber to the intermediate chamber. it can. Therefore, even if the communication path is formed, it is possible to reliably prevent the medicine from immediately flowing out from the storage chamber to the medicine discharge portion before use.

また、前記排出用封止部の開封強度を、前記仕切り用封止部の開封強度より小さくすることもでき、これにより次のような効果を得ることができる。このような医療用複室容器は、一般に、仕切り用封止部を開封して各収納室の薬剤を混合した後に、排出用封止部を開封して薬剤を排出部から排出するように使用される。このとき、排出用封止部を開封するには、連通した収納室全体を押圧して排出用封止部に圧力を作用させる必要がある。ここで、排出用封止部の開封強度を仕切り用封止部の開封強度より小さくしておくと、上記のように収納室全体を押圧するように押圧面積が広い場合であっても、排出用封止部を容易に開封することができる。   Moreover, the unsealing strength of the discharge sealing portion can be made smaller than the unsealing strength of the partitioning sealing portion, and the following effects can be obtained. Such a medical multi-chamber container is generally used to open the partition sealing portion and mix the medicine in each storage chamber, and then open the discharge sealing portion to discharge the medicine from the discharge portion. Is done. At this time, in order to open the discharge sealing portion, it is necessary to press the entire communicating storage chamber and apply pressure to the discharge sealing portion. Here, if the unsealing strength of the discharge sealing portion is made smaller than the unsealing strength of the partition sealing portion, even if the pressing area is large so as to press the entire storage chamber as described above, The sealing part can be easily opened.

なお、「開封強度」とは、各封止部の一部でも封止状態が解除され当該封止部により仕切られている各室を連通させるのに必要な力をいう。   The “opening strength” refers to a force necessary for communicating each chamber partitioned by the sealing portion after the sealed state is released even at a part of the sealing portion.

また、排出用封止部が、薬剤排出部を囲む略弧状に形成され、その両端部が薬剤排出部の近傍で容器本体の周縁部に連結するように構成することもできる。このようにすると、排出用封止部を小型化することができ、開封に際しての圧力を効率的に作用させることができる。   Further, the discharge sealing portion may be formed in a substantially arc shape surrounding the drug discharge portion, and both end portions thereof may be connected to the peripheral portion of the container main body in the vicinity of the drug discharge portion. If it does in this way, the sealing part for discharge can be reduced in size, and the pressure at the time of opening can be made to act efficiently.

このとき、連通路を、容器本体の周縁部近傍に形成すると、次の利点がある。すなわち、連通路は、封止されていない部分であるため、収納室内の圧力を高めると、連通路近傍から排出用封止部が開封することが多い。そのため、上記のように構成すると、連通路近傍、つまり容器本体周縁部に薬液の流れの障壁となる未開封部分が形成されるのを防止することができる。その結果、使用時に容器本体内の薬液が少なくなってきた場合であっても、薬液は周縁部に沿って排出部へと流れていき、ほとんどの薬液を無駄なく容器から薬剤排出部を介して外部へと排出することができる。   At this time, if the communication path is formed in the vicinity of the peripheral edge of the container body, the following advantages are obtained. That is, since the communication path is an unsealed part, when the pressure in the storage chamber is increased, the discharge sealing portion is often opened from the vicinity of the communication path. Therefore, if comprised as mentioned above, it can prevent that the unopened part used as the barrier | block of the flow of a chemical | medical solution is formed in the vicinity of a communicating path, ie, a container main body peripheral part. As a result, even when the chemical solution in the container main body becomes small at the time of use, the chemical solution flows along the peripheral edge to the discharge part, and most of the chemical solution is passed through the drug discharge part from the container without waste. It can be discharged to the outside.

上記医療用複室容器は、以下の2つの方法で製造することができる。すなわち、前記容器本体の周縁部を、薬剤の注入部分を残して封止する工程と、前記仕切り用封止部を形成して複数の収納室を形成する工程と、前記各収納室に薬液を注入する工程と、前記薬液の注入部分を封止する工程と、前記連通路を有する排出用封止部を形成する工程と、前記排出用封止部の形成後に、前記容器本体を加熱滅菌する工程とを備えた方法により製造することができる。   The medical multi-chamber container can be manufactured by the following two methods. That is, the step of sealing the peripheral portion of the container main body leaving the injection portion of the medicine, the step of forming the partition sealing portion to form a plurality of storage chambers, and the chemical solution in each storage chamber The step of injecting, the step of sealing the injection portion of the chemical solution, the step of forming the sealing portion for discharge having the communication path, and the formation of the sealing portion for discharge, heat sterilize the container body It can manufacture by the method provided with the process.

また、前記容器本体の周縁部を、薬剤の注入部分を残して封止する工程と、前記仕切り用封止部を形成して複数の収納室を形成する工程と、前記各収納室に薬液を注入する工程と、前記薬液の注入部分を封止する工程と、前記容器本体を加熱滅菌する工程と、前記加熱滅菌後に、前記連通路を有する排出用封止部を形成する工程とを備えた方法によっても製造することができる。なお、上記した薬剤の注入部分に上記薬剤排出部を設け、ここから収納室内へ薬剤を注入することもできる。   A step of sealing the peripheral portion of the container main body leaving a part for injecting a drug; a step of forming the partition sealing portion to form a plurality of storage chambers; and a chemical solution in each of the storage chambers. A step of injecting, a step of sealing the injection portion of the chemical solution, a step of heat sterilizing the container body, and a step of forming a discharge sealing portion having the communication path after the heat sterilization. It can also be produced by a method. In addition, the above-mentioned medicine discharge part is provided in the above-mentioned medicine injection portion, and the medicine can be injected from here into the storage chamber.

本発明に係る第2の医療用複室容器は、上記問題を解決するためになされたものであり、薬剤を収納する複数の収納室及び前記各収納室間を仕切る仕切り用封止部を有する容器本体と、該容器本体に取り付けられ前記収納室から薬剤を排出可能とする薬剤排出部とを備え、前記仕切り用封止部が、使用に際して前記各収納室を連通させるように開封可能に構成された医療用複室容器において、前記容器本体は、該容器本体の周縁部と連結して前記収納室と前記薬剤排出部との間を仕切り、使用に際して開封可能な排出用封止部を備えており、前記排出用封止部は、その端部の一方または双方の幅が中央部の幅より小さいことを特徴としている。   A second medical multi-chamber container according to the present invention is made to solve the above-described problem, and includes a plurality of storage chambers for storing a medicine and a partition sealing portion for partitioning the storage chambers. A container body, and a medicine discharge portion attached to the container body and capable of discharging the medicine from the storage chamber, wherein the partition sealing portion is configured to be openable so as to communicate with each of the storage chambers in use. In the medical multi-chamber container, the container main body includes a discharge sealing portion that is connected to a peripheral portion of the container main body to partition between the storage chamber and the drug discharge portion and can be opened for use. The discharge sealing portion is characterized in that the width of one or both of the end portions is smaller than the width of the central portion.

この構成によれば、排出用封止部の端部の幅が中央部よりも小さくなっており、例えば同一の圧力が作用した場合には、中央部よりも端部の方が開封しやすくなっている。ここで、容器本体を押圧して排出用封止部に作用する力は、その中央部に大きく作用する一方、端部に作用する力は小さいため未開封の部分が残ることがある。これに対して、上記のように構成すると、端部に作用する力が弱くても開封させることができるため、薬剤の排出の妨げとなる未開封部分が容器本体周縁部に生じるのを防止することができる。その結果、未開封部分が障壁となって薬剤の一部が容器本体中に残留するのを防止し、薬剤排出部から薬剤を確実に排出することができる。上記の場合、排出用封止部の両端部のうち、一方の端部の幅のみを小さくしてもよいが、未開封部分を確実になくして薬剤をスムーズに排出するためには、両端部の幅を小さくすることが好ましい。   According to this configuration, the width of the end portion of the discharge sealing portion is smaller than that of the central portion. For example, when the same pressure is applied, the end portion is easier to open than the central portion. ing. Here, the force acting on the discharge sealing portion by pressing the container main body acts largely on the central portion, while the force acting on the end portion is small, so that an unopened portion may remain. On the other hand, if comprised as mentioned above, since it can be opened even if the force which acts on an edge part is weak, it prevents that the unopened part which becomes the hindrance of discharge | emission of a chemical | medical agent arises in a container main body peripheral part. be able to. As a result, the unopened portion becomes a barrier to prevent a part of the medicine from remaining in the container body, and the medicine can be reliably discharged from the medicine discharging portion. In the above case, of the both ends of the discharge sealing portion, only the width of one end may be reduced, but in order to eliminate the unopened portion reliably and smoothly discharge the drug, both ends It is preferable to reduce the width.

なお、本明細書中にいう排出用封止部における「中央部」とは、開封時に破壊されずに封止状態のまま残りやすい両端部を除いた中央寄りの部分を意味する。   In addition, the “center portion” in the discharge sealing portion referred to in the present specification means a portion near the center excluding both end portions that are not destroyed at the time of opening and remain in a sealed state.

また、本発明に係る第3の医療用複室容器は、薬剤を収納する複数の収納室及び前記各収納室間を仕切る仕切り用封止部を有する容器本体と、該容器本体に取り付けられ前記収納室から薬剤を排出可能とする薬剤排出部とを備え、前記仕切り用封止部が、使用に際して前記各収納室を連通させるように開封可能に構成された医療用複室容器において、前記容器本体は、該容器本体の周縁部と連結して前記収納室と前記薬剤排出部との間を仕切り、使用に際して開封可能な排出用封止部を備えており、該排出用封止部の長手方向における単位長さあたりの封止解除強度は、該排出用封止部の両端部のうち少なくとも一方の端部のものが、中央部のものより小さくなるように構成されていることを特徴としている。   The third medical multi-chamber container according to the present invention includes a container main body having a plurality of storage chambers for storing a drug and a partition sealing portion for partitioning the storage chambers, and the container main body attached to the container main body, A medical multi-chamber container, comprising: a medicine discharge section capable of discharging a medicine from a storage chamber, wherein the partition sealing portion is configured to be openable so as to communicate with each of the storage chambers in use. The main body includes a discharge sealing portion that is connected to a peripheral portion of the container main body to partition between the storage chamber and the medicine discharge portion, and can be opened for use. The sealing release strength per unit length in the direction is configured so that at least one end portion of both ends of the discharge sealing portion is smaller than the central portion. Yes.

この構成によれば、排出用封止部の端部の封止解除強度が中央部よりも小さくなっている。そのため、例えば同一の圧力が作用した場合には、中央部よりも端部の方が開封しやすくなっている。したがって、上記第1の医療用複室容器と同様の効果を得ることができる。ここで、「封止解除強度」とは、上記のように排出用封止部の単位長さあたりの封止を解除するために必要な力をいい、例えば排出用封止部をフィルム面の熱融着により構成した場合には、JIS−Z0238に基づく方法で計測した力で表すことができる。   According to this configuration, the sealing release strength at the end of the discharge sealing portion is smaller than that at the center. Therefore, for example, when the same pressure is applied, the end portion is easier to open than the center portion. Therefore, the same effect as the first medical multi-chamber container can be obtained. Here, the “sealing release strength” refers to a force required to release the sealing per unit length of the discharge sealing portion as described above. When constituted by heat fusion, it can be expressed by a force measured by a method based on JIS-Z0238.

また、上記医療用複室容器において、排出用封止部の端部の封止解除強度を中央部より小さくするには、例えば次のような製造方法を採用することができる。すなわち、前記容器本体をプラスチックフィルムで構成するとともに、対向するプラスチックフィルムを熱融着することで排出用封止部を形成するにあたり、対向するプラスチックフィルムを挟む一対の金型として、排出用封止部の端部の一方又は双方を熱融着する一対の第1金型部と、その中央部を熱融着する一対の第2金型部とを備えたものを用い、前記一対の第1金型部間の距離を、前記一対の第2金型部間の距離よりも大きくして熱融着を行うことで排出用封止部を形成する。   Moreover, in the said medical multi-chamber container, in order to make the sealing release intensity | strength of the edge part of the discharge | emission sealing part smaller than a center part, the following manufacturing methods are employable, for example. That is, when the container body is made of a plastic film and the sealing part for discharging is formed by thermally fusing the opposing plastic film, the sealing for discharging is performed as a pair of molds sandwiching the opposing plastic film. A pair of first mold parts for heat-sealing one or both of the ends of the part and a pair of second mold parts for heat-sealing the central part, and the pair of first molds A discharge sealing portion is formed by performing heat fusion with a distance between the mold portions larger than a distance between the pair of second mold portions.

このようにすれば、排出用封止部を形成する金型において、この封止部の端部を形成する一対の第1金型部間の距離を、中央部を形成する一対の第2金型部間の距離よりも大きくして熱融着を行うため、端部に作用する熱融着時の圧力は中央部より小さくなる。これにより、端部付近の融着強度が中央部のものより確実に小さくなり、その結果、端部の封止解除強度を中央部より確実に小さくすることができる。   If it does in this way, in the metal mold | die which forms the sealing part for discharge | emission, the distance between a pair of 1st metal mold | die parts which form the edge part of this sealing part is made into a pair of 2nd metal mold | die which forms a center part Since heat fusion is performed with a distance larger than the distance between the mold parts, the pressure at the time of heat fusion acting on the end part is smaller than that in the central part. Thereby, the fusion | melting intensity | strength near an edge part becomes reliably smaller than the thing of a center part, As a result, the sealing release intensity | strength of an edge part can be reliably made smaller than a center part.

また、次の方法でも排出用封止部の端部の封止解除強度を中央部より小さくすることができる。すなわち、前記容器本体をプラスチックフィルムで構成するとともに、対向するプラスチックフィルムを熱融着することで排出用封止部を形成するにあたり、該熱融着のための加熱を同一箇所に少なくとも1回以上行うようにし、排出用封止部の端部の一方又は双方の加熱回数を、中央部の加熱回数より少なくすることで排出用封止部を形成する。これにより、加熱回数の少ない端部は、中央部よりも封止解除強度が小さくなり、中央部よりも確実に小さい力で開封することができる。   Also, the sealing release strength at the end of the discharge sealing portion can be made smaller than that at the central portion by the following method. That is, when the container body is made of a plastic film and the discharge plastic sealing portion is formed by heat-sealing the opposing plastic film, the heat for heat-sealing is applied at least once to the same location. Thus, the discharge sealing portion is formed by reducing the number of heating times of one or both of the end portions of the discharge sealing portion less than the number of heating times of the central portion. As a result, the end portion with fewer heating times has a lower sealing release strength than the central portion, and can be opened with a smaller force than the central portion.

さらに、次の方法を採用することもできる。すなわち、前記容器本体をプラスチックフィルムで構成するとともに、対向するプラスチックフィルムを熱融着することで排出用封止部を形成するにあたり、排出用封止部の端部の一方又は双方の融着温度を、中央部の融着温度よりも低くすることで前記排出用封止部を形成する。これによって、排出用封止部の端部の封止解除強度が、中央部より小さくなり、中央部より小さい力で確実に開封することができる。   Furthermore, the following method can also be employed. That is, when the container body is made of a plastic film and the discharge plastic sealing part is formed by heat-sealing the opposing plastic film, one or both of the fusion temperatures of the end part of the discharge sealing part Is made lower than the fusing temperature of the central portion to form the discharge sealing portion. Accordingly, the sealing release strength at the end of the discharge sealing portion is smaller than that at the central portion, and can be reliably opened with a force smaller than that at the central portion.

(第1実施形態)
以下、本発明に係る医療用複室容器の第1実施形態について図面を参照しつつ説明する。図1は本実施形態に係る医療用複室容器の平面図である。
(First embodiment)
Hereinafter, a first embodiment of a medical multi-chamber container according to the present invention will be described with reference to the drawings. FIG. 1 is a plan view of a medical multi-chamber container according to this embodiment.

図1に示すように、この医療用複室容器1は、2枚の水蒸気透過性プラスチックフィルムの周縁部3を熱融着することにより矩形状に形成された容器本体5と、この容器本体5に接続され内部にゴム栓を有する薬剤排出部7とを備えている。容器本体5は、長手方向に並べて配置され薬剤が封入される第1収納室9及び第2収納室11を有しており、2つの収納室9,11は仕切り用弱シール部(仕切り用封止部)13で仕切られている。第2収納室11には上記した薬剤排出部7が接続されており、この薬剤排出部7と対向する容器本体5の端部には、容器1を吊り掛けるための吊掛孔17が形成されている。   As shown in FIG. 1, this medical multi-chamber container 1 includes a container main body 5 formed in a rectangular shape by heat-sealing the peripheral edge portions 3 of two water vapor permeable plastic films, and the container main body 5 And a medicine discharge part 7 having a rubber plug inside. The container main body 5 has a first storage chamber 9 and a second storage chamber 11 which are arranged side by side in the longitudinal direction and in which a medicine is sealed. The two storage chambers 9 and 11 are each composed of a partition weak seal portion (a partition seal). (Stopped part) 13. The above-described medicine discharge part 7 is connected to the second storage chamber 11, and a hanging hole 17 for hanging the container 1 is formed at the end of the container body 5 facing the medicine discharge part 7. ing.

仕切り用弱シール部13は、容器本体5の対向する2枚のフィルムの内壁面同士を熱融着したものであり、容器本体5の長手方向と略垂直な方向に延びている。また、この仕切り用弱シール部13は、使用時は2つの収納室9,11を隔離し、使用に際して収納室内の圧力を高めることにより開封する程度の強度で融着されている。   The partition weak seal portion 13 is obtained by heat-sealing the inner wall surfaces of two opposing films of the container body 5 and extends in a direction substantially perpendicular to the longitudinal direction of the container body 5. In addition, the partition weak seal portion 13 is fused with a strength sufficient to isolate the two storage chambers 9 and 11 during use and increase the pressure in the storage chamber during use.

第2収納室11と薬剤排出部7との間には、これらの間の薬液の流通を遮断する排出用弱シール部(排出用封止部)21が形成されている。この排出用弱シール部21は、薬剤排出部7を囲むように円弧状に形成され、その両端部が薬剤排出部7近傍において容器本体5の周縁部3に連結されている。これにより、仕切り用弱シール部21と薬剤排出部7との間には、半円状の中間室23が形成される。   Between the 2nd storage chamber 11 and the chemical | medical agent discharge part 7, the discharge | emission weak seal part (sealing part for discharge | emission) 21 which interrupt | blocks the distribution | circulation of the chemical | medical solution between these is formed. The discharge weak seal portion 21 is formed in an arc shape so as to surround the drug discharge portion 7, and both end portions thereof are connected to the peripheral edge portion 3 of the container body 5 in the vicinity of the drug discharge portion 7. Thereby, a semicircular intermediate chamber 23 is formed between the partition weak seal portion 21 and the medicine discharge portion 7.

排出用弱シール部21における円弧の頂部には、幅の小さい連通路25が形成され、この連通路25を介して第2収納室11と中間室23とが連通されている。連通路25の幅は、1〜5mmにすることが好ましく、このようにすると、第2収納室11と中間室23との間で気体の流通が可能となる一方、中間室23内の空気の圧力により第2収納室11から中間室23への薬液の流入が抑制される。   A communication passage 25 having a small width is formed at the top of the arc in the discharge weak seal portion 21, and the second storage chamber 11 and the intermediate chamber 23 are communicated with each other through the communication passage 25. The width of the communication path 25 is preferably 1 to 5 mm, and in this way, gas can flow between the second storage chamber 11 and the intermediate chamber 23, while the air in the intermediate chamber 23 can flow. Inflow of the chemical liquid from the second storage chamber 11 to the intermediate chamber 23 is suppressed by the pressure.

排出用弱シール部21は、仕切り用弱シール部13と同様に、容器本体5の対向するフィルムの内壁面同士を熱融着することで形成されており、収納室9,11内の圧力を高めることにより、開封するように構成されている。このときの開封強度は、仕切り用弱シール部13の開封強度より小さくされている。   The discharge weak seal portion 21 is formed by heat-sealing the inner wall surfaces of the opposing films of the container body 5 in the same manner as the partition weak seal portion 13, and reduces the pressure in the storage chambers 9 and 11. It is configured to open by raising. The opening strength at this time is made smaller than the opening strength of the partition weak seal portion 13.

容器本体5を構成するフィルムの材質としては、ポリエチレン、ポリプロピレン、ポリスチレン等の熱可塑性樹脂等、種々の樹脂材料を採用することができる。また、単層のフィルムに限られず、多層構造のフィルムを使用することもでき、例えば、内外層がポリエチレン、ポリプロピレン等のポリオレフィンで、中間層が環状オレフィン系ポリマーである3層構造のフィルムを使用することができる。   As the material of the film constituting the container body 5, various resin materials such as thermoplastic resins such as polyethylene, polypropylene, and polystyrene can be employed. In addition, the film is not limited to a single-layer film, and a multilayer film can also be used. For example, a three-layer film in which the inner and outer layers are polyolefins such as polyethylene and polypropylene and the intermediate layer is a cyclic olefin polymer is used. can do.

各収納室9,11には、予め混合或いは溶解しておくとメイラード反応等の経時変化を起こすため隔離する必要がある各種薬剤a,bがそれぞれ封入されている。各収納室に封入される薬剤の組み合わせは、特に限定されないが、少なくとも第2収納室11には液状の薬剤を封入しておく必要がある。その理由については後に詳述する。各収納室9,11に封入される薬剤の例を挙げると、例えば、第1収納室9に抗生物質等の粉末剤、第2収納室11に生理食塩液等の溶解液を封入することができる。また、第1収納室9にアミノ酸溶液、第2収納室11に糖と電解質液との混合物を封入することができ、或いは第1収納室9に糖と脂肪乳剤との混合物、第2収納室11にアミノ酸と電解質液との混合物を封入することができる。   Each of the storage chambers 9 and 11 is filled with various drugs a and b that need to be isolated in order to cause a change over time such as a Maillard reaction if mixed or dissolved in advance. The combination of medicines enclosed in each storage chamber is not particularly limited, but at least the second storage chamber 11 needs to contain a liquid medicine. The reason will be described in detail later. As an example of the medicine sealed in each storage chamber 9, 11, for example, a powder agent such as antibiotics may be sealed in the first storage chamber 9, and a solution such as physiological saline may be sealed in the second storage chamber 11. it can. Further, the first storage chamber 9 can be filled with an amino acid solution, and the second storage chamber 11 can be filled with a mixture of sugar and electrolyte, or the first storage chamber 9 can be filled with a mixture of sugar and fat emulsion, and the second storage chamber. 11 can enclose a mixture of an amino acid and an electrolyte solution.

次に、上記のように構成された医療用複室容器の使用方法について説明する。複室容器1内の薬剤を患者に投与するには、まず、第1収納室9を手で押さえる等して押圧し、収納室内の圧力を高める。これにより、仕切り用弱シール部13が開封して第1及び第2収納室9,11が連通し、各収納室9,11内の薬剤が混合される。続いて、薬剤排出部7のゴム栓に導管付き刺栓針を刺入した後、第1及び第2収納室9,11全体を押圧して、連通した収納室9,11内全体の圧力を高め、排出用弱シール部21を開封する。この場合、排出用弱シール部21を開封した後に、刺栓針を刺入してもよい。こうして、容器1内の混合薬剤は、排出部32から導管を経て患者に投与される。   Next, the usage method of the medical multi-chamber container comprised as mentioned above is demonstrated. In order to administer the medicine in the multi-chamber container 1 to the patient, first, the first storage chamber 9 is pressed by hand or the like to increase the pressure in the storage chamber. Thereby, the weak seal part 13 for a partition is opened, the 1st and 2nd storage chambers 9 and 11 are connected, and the chemical | medical agent in each storage chamber 9 and 11 is mixed. Subsequently, after inserting a piercing needle with a conduit into the rubber stopper of the medicine discharge section 7, the entire first and second storage chambers 9 and 11 are pressed to reduce the pressure in the entire storage chambers 9 and 11 communicated. Open the weak seal 21 for discharge. In this case, the piercing needle may be inserted after the discharge weak seal portion 21 is opened. Thus, the mixed medicine in the container 1 is administered to the patient from the discharge part 32 via the conduit.

ここで、排出用弱シール部21の開封強度は、仕切り用弱シール部13の開封強度より小さいため、次の利点がある。上記のように、この容器1は仕切り用弱シール部13を開封して2つの薬剤を混合した後に、排出用弱シール部21を開封する。ここで、仕切り用弱シール部13を開封する際には、第1収納室9のみを押圧すればよいが、排出用弱シール部21を開封する際には、第1及び第2収納部9,11全体を押圧しなければならない。そのため、例えば両シール部13,21の開封強度が同一である場合に排出用弱シール部21を開封するには、押圧面積が広いため仕切り用弱シール部13を開封するより大きな力が必要になり、開封が困難になる。そこで、上記のように排出用弱シール部21の開封圧力を小さくしておくと、押圧面積が広くても、容易に開封することができる。   Here, since the unsealing strength of the discharge weak seal portion 21 is smaller than the unsealing strength of the partition weak seal portion 13, the following advantages are obtained. As described above, the container 1 opens the discharge weak seal portion 21 after opening the partition weak seal portion 13 and mixing the two chemicals. Here, when opening the partition weak seal portion 13, it is only necessary to press the first storage chamber 9, but when opening the discharge weak seal portion 21, the first and second storage portions 9 are pressed. , 11 must be pressed. Therefore, for example, in order to open the discharge weak seal portion 21 when both the seal portions 13 and 21 have the same opening strength, a larger force is required to open the partition weak seal portion 13 because the pressing area is wide. It becomes difficult to open. Therefore, if the opening pressure of the discharge weak seal portion 21 is reduced as described above, it can be easily opened even if the pressing area is large.

続いて、この医療用複室用の製造方法について図2を参照しつつ説明する。ここでは、第1収納室9については省略し、第2収納室11の製造工程について説明する。なお、図2では、図1の複室容器の上下方向を反対にして説明している。   Next, a manufacturing method for this medical multi-chamber will be described with reference to FIG. Here, the first storage chamber 9 is omitted, and the manufacturing process of the second storage chamber 11 will be described. In FIG. 2, the description is made with the vertical direction of the multi-chamber container of FIG. 1 reversed.

まず、容器本体周縁部3のうち、両側縁部のみを熱融着した後、これより小さい融着強度で仕切り用弱シール部13を熱融着により形成する(図2(a))。次に、容器本体5の端部に薬剤排出部7を取り付けるとともに、熱融着をして容器本体周縁部3を封止する(図2(b))。続いて、薬剤排出部7から薬液を注入した後、薬剤排出部7にゴム栓(図示省略)を嵌入して封止する(図2(c))。これに続いて、薬剤排出部7を囲むように排出用弱シール部21を熱融着により形成した後(図2(d))、容器本体5を加熱滅菌する。なお、第1収納室9については、図2(b)の状態で、薬剤排出部7を設ける代わりに薬剤注入用の孔を形成し、この孔から薬剤を注入した後に、熱融着によってこの孔を塞ぐと、第1収納室9が形成される。   First, only the side edge portions of the container body peripheral edge portion 3 are thermally fused, and then the partition weak seal portion 13 is formed by thermal fusion with a smaller fusion strength (FIG. 2A). Next, while attaching the chemical | medical agent discharge part 7 to the edge part of the container main body 5, it heat-seals and seals the container main body peripheral part 3 (FIG.2 (b)). Subsequently, after injecting the chemical solution from the medicine discharge section 7, a rubber stopper (not shown) is inserted into the medicine discharge section 7 and sealed (FIG. 2 (c)). Subsequently, after forming the discharge weak seal portion 21 so as to surround the medicine discharge portion 7 by heat fusion (FIG. 2D), the container body 5 is sterilized by heating. In the state shown in FIG. 2B, the first storage chamber 9 is formed with a drug injection hole instead of providing the drug discharge portion 7, and after the drug is injected from the hole, this is performed by heat fusion. When the hole is closed, the first storage chamber 9 is formed.

以上のように、本実施形態によれば、第2収納室11と薬剤排出部7との間に形成される排出用弱シール部21に、小幅の連通孔25が形成されており、この連通路25が、気体の通過を許容する一方、液体の通過を抑制するものであるため、従来問題であった次の点が解決される。すなわち、製造工程においては、容器本体5を加熱し、薬液から蒸発した蒸気により収納室9,11内部を滅菌している。しかしながら、中間室23には薬液がほとんど存在しない場合が多く、容器本体5を加熱しても中間室23には蒸気が発生しないため、従来例では中間室23内が十分に滅菌されているかが保証されなかった。   As described above, according to the present embodiment, the small communication hole 25 is formed in the discharge weak seal portion 21 formed between the second storage chamber 11 and the medicine discharge portion 7. Since the passage 25 allows the passage of gas while suppressing the passage of liquid, the following problems that have been the conventional problems are solved. That is, in the manufacturing process, the container body 5 is heated and the interiors of the storage chambers 9 and 11 are sterilized by the vapor evaporated from the chemical solution. However, since there is often no chemical solution in the intermediate chamber 23 and no steam is generated in the intermediate chamber 23 even when the container body 5 is heated, whether the intermediate chamber 23 is sufficiently sterilized in the conventional example. It was not guaranteed.

これに対して、本実施形態に係る医療用複室容器では、上記のように排出用弱シール部21に隣接する第2収納室11に薬液が封入されるとともに、この排出用弱シール部21に気体が通過可能な連通路25が形成されているため、第2収納室11で発生した蒸気を中間室23へ流入させることができる。これにより、中間室23内を十分に滅菌することが可能となる。なお、薬液は連通路25を通過しないため、排出用弱シール部21が開封するまでは、第2収納室11内の薬液が薬剤排出部7側へ流出することはない。   On the other hand, in the medical multi-chamber container according to the present embodiment, the chemical solution is sealed in the second storage chamber 11 adjacent to the discharge weak seal portion 21 as described above, and the discharge weak seal portion 21. Since the communication passage 25 through which the gas can pass is formed, the steam generated in the second storage chamber 11 can flow into the intermediate chamber 23. Thereby, the inside of the intermediate chamber 23 can be sufficiently sterilized. In addition, since a chemical | medical solution does not pass through the communicating path 25, the chemical | medical solution in the 2nd storage chamber 11 does not flow out to the chemical | medical agent discharge part 7 side until the discharge weak seal part 21 opens.

また、従来例では次のような問題もあった。図2(c)に示すように、薬液を注入したときに、薬剤排出部7の近傍には、僅かではあるが薬液が付着することがあり、その薬液は図2(d)のように排出用弱シール部21が形成されると中間室23内に位置することがある。この場合、容器の保管中に中間室23内の薬液から水分が蒸発し、結晶が析出することがある。そのため、この結晶がこのまま残留すると、薬液とともに結晶が患者へ投与されるおそれがあった。   The conventional example also has the following problems. As shown in FIG. 2 (c), when a chemical solution is injected, a small amount of chemical solution may adhere to the vicinity of the drug discharge portion 7, and the chemical solution is discharged as shown in FIG. 2 (d). When the weak seal portion 21 is formed, it may be located in the intermediate chamber 23. In this case, moisture may evaporate from the chemical solution in the intermediate chamber 23 during storage of the container, and crystals may precipitate. Therefore, if this crystal remains as it is, there is a risk that the crystal is administered to the patient together with the drug solution.

これに対して、本実施形態の医療用複室容器では、第2収納室11内の蒸気が中間室23内にも流入するため、中間室23内に薬液が付着していてもその水分が蒸発しにくく、中間室23内で結晶が析出するのが防止される。なお、中間室23内に薬液が残留している場合であっても、その量はごく僅かであるので、問題となることはなく、また薬剤排出部7を上に向けて保管しておけば、第2収納室11内に徐々に移動することもある。   On the other hand, in the medical multi-chamber container of the present embodiment, the vapor in the second storage chamber 11 also flows into the intermediate chamber 23, so that moisture remains even if the chemical solution adheres in the intermediate chamber 23. It is difficult to evaporate and it is possible to prevent crystals from being deposited in the intermediate chamber 23. Even if the chemical solution remains in the intermediate chamber 23, the amount of the chemical solution is very small, so there is no problem, and the medicine discharge unit 7 should be stored with the side facing upward. In some cases, it gradually moves into the second storage chamber 11.

上記実施形態では、連通路25を排出用弱シール部21の頂部に設けているが、図3(a)及び(b)に示すように、容器本体5の周縁部3の近傍に設けることもできる。これにより次の効果を得ることができる。連通路25は、熱融着がなされていない部分であるため、収納室9,11内の圧力を高めると、連通路25近傍から排出用弱シール部21が開封することが多い。そのため、上記のように構成すると、連通路25近傍、つまり容器本体周縁部3に薬液の流れの障壁となる未開封部分が形成されるのを防ぐことができる。その結果、図3(c)に示すように、使用時に容器本体5内の薬液が少なくなってきた場合に未開封部分が残っても、この部分によって容器内に留まる薬液を最小限にすることができ、ほとんどの薬液を無駄なく容器から薬剤排出部7を介して外部へと排出することができる。   In the above embodiment, the communication passage 25 is provided at the top of the discharge weak seal portion 21. However, as shown in FIGS. 3A and 3B, the communication passage 25 may be provided in the vicinity of the peripheral portion 3 of the container body 5. it can. As a result, the following effects can be obtained. Since the communication passage 25 is a portion that is not heat-sealed, the discharge weak seal portion 21 is often opened from the vicinity of the communication passage 25 when the pressure in the storage chambers 9 and 11 is increased. Therefore, if comprised as mentioned above, it can prevent that the unopened part used as the barrier of the flow of a chemical | medical solution is formed in the communicating path 25 vicinity, ie, the container main body peripheral part 3. FIG. As a result, as shown in FIG. 3 (c), even if an unopened portion remains when the chemical solution in the container body 5 decreases during use, this portion minimizes the chemical solution remaining in the container. Therefore, most of the chemical solution can be discharged from the container to the outside through the drug discharge unit 7 without waste.

また、上記実施形態では、排出用弱シール部23を円弧状に形成しているが、その形状は特には限定されず、例えば半長円形や角部を有する略円弧状としたり、或いは図4に示すように、容器本体5の両側を結ぶように直線状に形成することもできる。また、連通路25は、必ずしも同一の幅で形成する必要はなく、液体の流通を抑制できるように形成されていればよく、特に最も狭い部分の幅が1〜5mmであるとその効果を十分に得ることができる。さらに連通路25は、薬剤の通過が抑制されていれば、上記のように1箇所に限らず複数箇所に設けてもよい。   Moreover, in the said embodiment, although the discharge | emission weak seal part 23 is formed in circular arc shape, the shape is not specifically limited, For example, it is made into the substantially circular arc shape which has a semi-oval shape or a corner | angular part, or FIG. As shown in FIG. 4, it can also be formed in a straight line so as to connect both sides of the container body 5. Further, the communication path 25 does not necessarily have to be formed with the same width, and may be formed so as to be able to suppress the flow of the liquid. The effect is particularly sufficient when the width of the narrowest portion is 1 to 5 mm. Can get to. Furthermore, as long as the passage of the medicine is suppressed, the communication path 25 is not limited to one place as described above, and may be provided at a plurality of places.

(第2実施形態)
次に、本発明の第2実施形態について図面を参照しつつ説明する。図5は、本実施形態にかかる医療用複室容器の平面図である。本実施形態が第1実施形態と相違するのは、排出用弱シール部の構成であり、その他の構成は、第1実施形態と同様であるので、同一構成には同一符号を付してその説明を省略する。
(Second Embodiment)
Next, a second embodiment of the present invention will be described with reference to the drawings. FIG. 5 is a plan view of the medical multi-chamber container according to the present embodiment. The present embodiment differs from the first embodiment in the configuration of the discharge weak seal portion, and the other configurations are the same as those in the first embodiment. Description is omitted.

図5に示すように、本実施形態では、この排出用弱シール部21では、段差を設けて両端部21aの幅が中央部21bの幅よりも小さくなるようにしている。これにより、例えば同じ圧力が作用した場合には、中央部21bよりも両端部21aの方が開封しやすくなる。このような幅の差としては、例えば両端部21aの幅が中央部21bの幅の10〜80%となるようにすることが好ましい。   As shown in FIG. 5, in the present embodiment, in the discharge weak seal portion 21, a step is provided so that the width of both end portions 21a is smaller than the width of the central portion 21b. Thereby, for example, when the same pressure is applied, the end portions 21a are easier to open than the center portion 21b. As such a width difference, for example, it is preferable that the width of both end portions 21a is 10 to 80% of the width of the central portion 21b.

このような構成によれば、次のような利点がある。すなわち、容器本体5を押圧したときに排出用弱シール部21に作用する力は、その中央部21bに大きく作用する一方、端部付近21aに作用する力は小さいことがあり、これによって未開封の部分が残ることがある。これに対して、上記のように構成すると、排出用弱シール部21の両端部21aの幅が中央部21bよりも小さくなっているため、端部21b付近に作用する力が弱くても開封させることができ、排出用弱シール部21全体を確実に開封することができる。その結果、未開封部分が容器本体周縁部3に残ることにより薬剤の流れが妨げられるのが防止され、薬剤の一部が容器本体5中に残留するのを防止できる。したがって、薬剤排出部7から薬剤を確実に排出することができ、適量の薬剤を患者に対して確実に投与することができる。   Such a configuration has the following advantages. That is, when the container body 5 is pressed, the force acting on the discharge weak seal portion 21 acts largely on the central portion 21b, while the force acting on the end vicinity 21a may be small, and thus unopened May remain. On the other hand, if comprised as mentioned above, since the width | variety of the both ends 21a of the weak seal part 21 for discharge | emission is smaller than the center part 21b, it is opened even if the force which acts near the edge part 21b is weak. Thus, the entire discharge weak seal portion 21 can be reliably opened. As a result, it is possible to prevent the flow of the medicine from being hindered by the unopened portion remaining in the peripheral portion 3 of the container body, and to prevent a part of the medicine from remaining in the container body 5. Therefore, the medicine can be reliably discharged from the medicine discharge section 7, and an appropriate amount of the medicine can be reliably administered to the patient.

なお、排出用弱シール部の両端部21aを中央部21bより開封しやすくするには、上記のように段差を設ける以外に、次のようにすることができる。例えば図6(a)に示すように、中央部から両端部へといくにしたがって、その幅を漸進的に小さくすることもできる。また、排出用弱シール部21の形状は、上記のように円弧状に限られず、例えば図6(b)に示すように、多角形状に形成し、容器本体周縁部3に連結する両端部21aの幅を小さくすることもできる。   In addition, in order to make it easier to open the both end portions 21a of the discharge weak seal portion than the central portion 21b, the following can be performed in addition to providing the step as described above. For example, as shown to Fig.6 (a), the width | variety can also be made small gradually as it goes to both ends from a center part. Further, the shape of the discharge weak seal portion 21 is not limited to the arc shape as described above. For example, as shown in FIG. 6B, both end portions 21 a that are formed in a polygonal shape and are connected to the peripheral portion 3 of the container body. The width of the can also be reduced.

また、上記説明では、排出用弱シール部21の両端部21aを周縁部3のうち、薬剤排出部7が設けられている下端辺3aに連結しているが、図7に示すように、両側端辺3bに連結してもよい。この場合も両側端辺3bに連結している両端部21aの幅を小さくする必要があるが、図7(a)のように段差を設けて両端部21aの幅を小さくしてもよいし、図7(b)のように中央部21bから両端部21aに向けて漸進的に幅を小さくするようにしてもよい。或いは、図8に示すように、排出用弱シール部21の両端部21aのうち、一方の端部を薬剤排出部7が設けられている下端辺3aに連結するとともに、他方の端部を側端辺3bに連結することもできる。また、上記した各排出用弱シール部21では、両端部21aの幅を小さくしているが、そのうちの一方の端部の幅のみを小さくすることもできる。但し、未開封部分を確実になくすためには、両端部の幅を小さくすることが好ましい。   In the above description, both end portions 21a of the discharge weak seal portion 21 are connected to the lower end side 3a of the peripheral edge portion 3 where the medicine discharge portion 7 is provided. However, as shown in FIG. You may connect with the edge 3b. In this case as well, it is necessary to reduce the width of both end portions 21a connected to both side edges 3b, but the width of both end portions 21a may be reduced by providing a step as shown in FIG. As shown in FIG. 7B, the width may be gradually reduced from the central portion 21b toward both end portions 21a. Alternatively, as shown in FIG. 8, one end of both ends 21 a of the discharge weak seal portion 21 is connected to the lower end side 3 a where the medicine discharge portion 7 is provided, and the other end is connected to the side. It can also be connected to the end side 3b. Further, in each of the discharge weak seal portions 21 described above, the width of both end portions 21a is reduced, but only the width of one end portion can be reduced. However, in order to surely eliminate the unopened portion, it is preferable to reduce the width of both end portions.

ところで、上記のような医療用複室容器では、排出用弱シール部21の幅を調整することでその両端部を開封しやすくしているが、幅を同一のままにして中央部と両端部との融着条件を変えることで両端部を開封しやすくすることもできる。例えば、排出用弱シール部21を形成する金型において、図9(a)に示すように、両端部21aの融着温度を中央部21bより小さくして熱融着を行うこともできる。すなわち、中央部21bが高温融着部となる一方、両端部21aが低温融着部となる。このときの融着温度の差は、0.3〜10℃にするのが好ましい。これにより、両端部21aの封止解除強度が中央部21bよりも小さくなる。   By the way, in the medical multi-chamber container as described above, it is easy to open both ends by adjusting the width of the discharge weak seal portion 21, but the center portion and both end portions are kept the same width. Both ends can be easily opened by changing the fusing conditions. For example, in the mold for forming the discharge weak seal portion 21, as shown in FIG. 9A, the fusion bonding temperature of both end portions 21a can be made lower than that of the central portion 21b to perform heat fusion. That is, the central portion 21b is a high temperature fusion portion, while the both end portions 21a are low temperature fusion portions. The difference in fusion temperature at this time is preferably 0.3 to 10 ° C. Thereby, the sealing release strength of the both end portions 21a is smaller than that of the central portion 21b.

ここで、「封止解除強度」とは、排出用弱シール部21の長手方向における単位長さあたりで、封止状態が解除される強度、つまり融着している2つのフィルム面が離間するときの強度をいう。この封止解除強度は、例えばJIS−Z0238に示される剥離強度で表すことができる。この剥離強度とは、幅15mmの弱シール部において熱融着している2つのフィルム面を離間させるのに必要な力をいう。この場合、排出用弱シール部13の中央部21bの剥離強度を1〜7N/15mmとし、その両端部21aの剥離強度を中央部の25〜90%とすることが好ましい。   Here, “sealing release strength” means the strength at which the sealed state is released, that is, the two film surfaces that are fused are separated from each other in the unit length in the longitudinal direction of the discharge weak seal portion 21. The strength of time. This sealing release strength can be expressed by, for example, peel strength shown in JIS-Z0238. The peel strength is a force necessary to separate two film surfaces that are heat-sealed in a weak seal portion having a width of 15 mm. In this case, it is preferable that the peel strength of the central portion 21b of the discharge weak seal portion 13 is 1 to 7 N / 15 mm, and the peel strength of both end portions 21a is 25 to 90% of the central portion.

また、両端部21aの融着回数を中央部21bよりも少なくすることによっても、両端部21aの封止解除強度を小さくすることできる。この場合、例えば図9(b)に示すように、一回目の熱融着は、円弧状の金型を使用して排出用弱シール部21全体を形成し、二回目の熱融着では、複数のドットからなる金型で中央部のみを融着することもできる。なお、二回目の金型はドット型でなくてもよく、円弧の一部の形状であってもよい。以上のようにすることでも中央部21bの封止解除強度を強くし、両端部21aの封止解除強度を小さくすることができる。また、それぞれの箇所に二回以上の熱融着を行うこともできる。   Further, the sealing release strength of the both end portions 21a can be reduced also by reducing the number of times of fusion of the both end portions 21a as compared with the central portion 21b. In this case, for example, as shown in FIG. 9 (b), the first heat fusion forms an entire discharge weak seal portion 21 using an arc-shaped mold, and in the second heat fusion, It is also possible to fuse only the central portion with a mold composed of a plurality of dots. Note that the second mold may not be a dot mold but may be a partial arc shape. Also by doing as described above, the sealing release strength of the central portion 21b can be increased, and the sealing release strength of the both end portions 21a can be reduced. In addition, it is possible to perform heat fusion twice or more at each location.

また、図10に示すように、金型の高さを変えることで封止解除強度を調整することもできる。すなわち、排出用弱シール部21を形成する一対の金型41を、両端部21aを形成する第1金型部41aと、中央部21bを形成する第2金型部41bとから構成し、第2金型部41bの高さを第1金型部41aより高くなるようにする。こうすることにより、熱融着するときに、両端部と中央部とで金型間の距離が相違するようになり、金型間の距離が大きい両端部21aの方が融着強度が小さくなる。したがって、両端部21aの封止解除強度を中央部21aよりも小さくすることができる。なお、第1金型部41aと第2金型部41bとの高さの差は、例えば、20〜80μmであることが好ましい。   Further, as shown in FIG. 10, the sealing release strength can be adjusted by changing the height of the mold. That is, the pair of molds 41 forming the discharge weak seal part 21 is composed of a first mold part 41a that forms both end parts 21a and a second mold part 41b that forms the central part 21b. The height of the two mold parts 41b is made higher than that of the first mold part 41a. By doing so, when heat-sealing, the distance between the molds is different between the both end portions and the central portion, and the fusion strength is lower at both end portions 21a where the distance between the molds is larger. . Therefore, the sealing release strength of both end portions 21a can be made smaller than that of the central portion 21a. In addition, it is preferable that the difference of the height of the 1st metal mold | die part 41a and the 2nd metal mold | die part 41b is 20-80 micrometers, for example.

ところで、排出用弱シール部21における上記のような構成は、第1実施形態の複室容器に適用することができる。すなわち、図11に示すように、排出用弱シール部の中央部に、連通路を形成するとともに、両端部21aの幅が中央部21bの幅よりも小さくなるようにすることができる。これ以外にも、排出用弱シール部の両端部21aを中央部21bより開封しやすくする図6〜図9に示す排出用弱シール部に、第1実施形態に示す連通路を形成することもできる。   By the way, the above structure in the discharge | emission weak seal part 21 is applicable to the multi-chamber container of 1st Embodiment. That is, as shown in FIG. 11, a communication path can be formed in the central portion of the discharge weak seal portion, and the width of both end portions 21a can be made smaller than the width of the central portion 21b. In addition to this, it is also possible to form the communication path shown in the first embodiment in the discharge weak seal portion shown in FIGS. 6 to 9 that makes it easier to open the both end portions 21a of the discharge weak seal portion than the central portion 21b. it can.

以上、本発明の一実施形態について説明したが、本発明はこれに限定されるものではなく、その趣旨を逸脱しない限りにおいて種々の変更が可能である。例えば、上記各実施形態では、仕切り用弱シール部13及び排出用弱シール部21をフィルムの熱融着によって構成しているが、本発明の封止部はこれに限定されるものではなく、外部からの力の作用によって開封するものであれば、種々の態様を採ることができる。例えば、容器本体5の対向する各フィルム面に凸条部及び凹条部をそれぞれ設け、これらを離脱可能に凹凸嵌合させることによって構成することもできる。或いは、一部が他の部分より薄くなっている仕切り用の膜を設け、圧力が作用するとこの薄い部分が破断して両収納室が連通するようにすることもできる。そして、このような封止部に気体の流通を許容し、液体の流通を抑制する連通路が形成されていれば、本発明の効果を得ることができ、特に、連通路の最も狭い部分の幅、または径が1〜5mmであれば好ましい。   As mentioned above, although one Embodiment of this invention was described, this invention is not limited to this, A various change is possible unless it deviates from the meaning. For example, in each of the above embodiments, the partition weak seal portion 13 and the discharge weak seal portion 21 are configured by thermal fusion of the film, but the sealing portion of the present invention is not limited to this, As long as it is opened by the action of an external force, various modes can be adopted. For example, it can also comprise by providing a convex strip part and a concave strip part in each film surface which the container main body 5 opposes, and making these concavo-convex fitting so that these are detachable. Alternatively, a partitioning film having a part thinner than the other part can be provided, and when the pressure is applied, the thin part can be broken so that the two storage chambers communicate with each other. And if the communication path which permits the flow of gas in such a sealing part and suppresses the flow of the liquid is formed, the effect of the present invention can be obtained, and particularly the narrowest part of the communication path. A width or diameter of 1 to 5 mm is preferable.

また、収納室の数は、上記のように2つに限定されるものではなく、3つ以上にすることもでき、この場合、各収納室を上記のような仕切り用封止部で仕切っていればよい。   In addition, the number of storage chambers is not limited to two as described above, and may be three or more. In this case, each storage chamber is partitioned by the partition sealing portion as described above. Just do it.

また、製造方法について、上記第1実施形態では排出用弱シール部(排出用封止部)21を形成した後に、容器本体5の加熱滅菌を行っているが、これを反対、つまり容器本体5の加熱滅菌を行ってから排出用弱シール部21を形成することもできる。この場合にも、上記と同様の効果を得ることができる。すなわち、中間室23内に薬液が付着している場合であっても、第2収納室11と中間室23とが連通しているため、中間室23内が乾燥して結晶が析出するのを防止することができる。   In the first embodiment, the container main body 5 is sterilized by heating after the discharge weak seal portion (discharge sealing portion) 21 is formed in the first embodiment. It is also possible to form the discharge weak seal portion 21 after heat sterilization. In this case, the same effect as described above can be obtained. That is, even when the chemical solution is adhered in the intermediate chamber 23, the second storage chamber 11 and the intermediate chamber 23 communicate with each other, so that the intermediate chamber 23 is dried and crystals are precipitated. Can be prevented.

本発明により、排出用封止部と薬剤排出部との間の中間室を十分に滅菌することができ、しかも、この中間室に薬液の結晶が残留するのを確実に防止することができる医療用複室容器及びその製造方法が提供される。また、本発明により、未開封部分を残さずに排出用封止部を開封することができ、容器内の薬液を確実に投与することができる医療用複室容器及びその製造方法が提供される。   According to the present invention, the intermediate chamber between the discharge sealing portion and the drug discharge portion can be sufficiently sterilized, and the medical liquid crystal can be reliably prevented from remaining in the intermediate chamber. A multi-chamber container and a method for manufacturing the same are provided. The present invention also provides a medical multi-chamber container that can open the discharge sealing portion without leaving an unopened portion and can reliably administer the chemical solution in the container, and a method for manufacturing the same. .

本発明に係る医療用複室容器の第1実施形態を示す平面図である。It is a top view which shows 1st Embodiment of the medical multi-chamber container which concerns on this invention. 図1に係る医療用複室容器の製造方法を示す図である。It is a figure which shows the manufacturing method of the medical multiple chamber container which concerns on FIG. 図1の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 図1の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 本発明に係る医療用複室容器の第2実施形態を示す平面図である。It is a top view which shows 2nd Embodiment of the medical multi-chamber container which concerns on this invention. 図5の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 図5の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 図5の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 図5の医療用複室容器の他の例を示す平面図である。It is a top view which shows the other example of the medical multiple chamber container of FIG. 図5の医療用複室容器における排出用封止部を形成するための金型の一例を示す断面図である。It is sectional drawing which shows an example of the metal mold | die for forming the sealing part for discharge | emission in the medical multiple chamber container of FIG. 第2実施形態に係る医療用複室容器の変形例を示す平面図である。It is a top view which shows the modification of the medical multi-chamber container which concerns on 2nd Embodiment. 従来の医療用複室容器を示す平面図である。It is a top view which shows the conventional medical multiple chamber container.

Claims (6)

薬剤を収納する複数の収納室及び前記各収納室間を仕切る仕切り用封止部を有する容器本体と、該容器本体に取り付けられ前記収納室から薬剤を排出可能とする薬剤排出部とを備え、前記仕切り用封止部が、使用に際して前記各収納室を連通させるように開封可能に構成された医療用複室容器において、  A container main body having a plurality of storage chambers for storing a drug and a partition sealing portion for partitioning each of the storage chambers; and a drug discharge unit attached to the container main body and capable of discharging the drug from the storage chamber; In the medical multi-chamber container configured so that the partition sealing portion can be opened so as to communicate each storage chamber in use,
前記容器本体は、該容器本体の周縁部と連結して前記収納室と前記薬剤排出部との間を仕切り、使用に際して開封可能な排出用封止部を備えており、  The container body is connected to a peripheral portion of the container body to partition the storage chamber and the medicine discharge part, and includes a discharge sealing part that can be opened for use.
前記排出用封止部は、その端部の一方または双方の幅が中央部の幅より小さいことを特徴とする医療用複室容器。  The discharge sealing part is a medical multi-chamber container characterized in that the width of one or both ends of the sealing part is smaller than the width of the central part.
薬剤を収納する複数の収納室及び前記各収納室間を仕切る仕切り用封止部を有する容器本体と、該容器本体に取り付けられ前記収納室から薬剤を排出可能とする薬剤排出部とを備え、前記仕切り用封止部が、使用に際して前記各収納室を連通させるように開封可能に構成された医療用複室容器において、  A container main body having a plurality of storage chambers for storing a drug and a partition sealing portion for partitioning each of the storage chambers; and a drug discharge unit attached to the container main body and capable of discharging the drug from the storage chamber; In the medical multi-chamber container configured so that the partition sealing portion can be opened so as to communicate each storage chamber in use,
前記容器本体は、該容器本体の周縁部と連結して前記収納室と前記薬剤排出部との間を仕切り、使用に際して開封可能な排出用封止部を備えており、  The container body is connected to a peripheral portion of the container body to partition the storage chamber and the medicine discharge part, and includes a discharge sealing part that can be opened for use.
該排出用封止部の長手方向における単位長さあたりの封止解除強度は、該排出用封止部の両端部のうち少なくとも一方の端部のものが、中央部のものより小さくなるように構成されていることを特徴とする医療用複室容器。  The sealing release strength per unit length in the longitudinal direction of the discharge sealing portion is such that at least one end portion of both end portions of the discharge sealing portion is smaller than that at the central portion. A multi-chamber container for medical use characterized by being configured.
前記排出用封止部は、その端部の一方又は双方の幅が前記中央部の幅の10〜80%であることを特徴とする請求項1に記載の医療用複室容器。  2. The medical multi-chamber container according to claim 1, wherein a width of one or both of the end portions of the discharge sealing portion is 10 to 80% of a width of the central portion. 前記排出用封止部の封止解除強度は、その中央部の剥離強度を1〜7N/15mmとし、その両端部のうち少なくとも一方の端部の剥離強度を前記中央部の剥離強度の25〜90%とすることを特徴とする、請求項2に記載の医療用複室容器。  The sealing release strength of the discharge sealing portion is such that the peel strength at the center is 1 to 7 N / 15 mm, and the peel strength at least one of the both ends is 25 to 25% of the peel strength at the center. The medical multi-chamber container according to claim 2, wherein the container is 90%. 前記排出用封止部の開封強度が、前記仕切り用封止部の開封強度より小さい、請求項1〜4のいずれかに記載の医療用複室容器。  The medical multi-chamber container according to any one of claims 1 to 4, wherein an opening strength of the discharge sealing portion is smaller than an opening strength of the partition sealing portion. 前記排出用封止部は、前記薬剤排出部を囲む略弧状に形成されており、その両端部が前記薬剤排出部の近傍で前記容器本体の周縁部に連結されていることを特徴とする請求項1〜5のいずれかに記載の医療用複室容器。  The discharge sealing portion is formed in a substantially arc shape surrounding the drug discharge portion, and both end portions thereof are connected to a peripheral portion of the container main body in the vicinity of the drug discharge portion. Item 6. A medical multi-chamber container according to any one of Items 1 to 5.
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