CA2076773C - Drug container and dual container system for fluid therapy employing the same - Google Patents
Drug container and dual container system for fluid therapy employing the same Download PDFInfo
- Publication number
- CA2076773C CA2076773C CA 2076773 CA2076773A CA2076773C CA 2076773 C CA2076773 C CA 2076773C CA 2076773 CA2076773 CA 2076773 CA 2076773 A CA2076773 A CA 2076773A CA 2076773 C CA2076773 C CA 2076773C
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- Prior art keywords
- container
- mouth portion
- container body
- drug
- packing
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D41/00—Caps, e.g. crown caps or crown seals, i.e. members having parts arranged for engagement with the external periphery of a neck or wall defining a pouring opening or discharge aperture; Protective cap-like covers for closure members, e.g. decorative covers of metal foil or paper
- B65D41/32—Caps or cap-like covers with lines of weakness, tearing-strips, tags, or like opening or removal devices, e.g. to facilitate formation of pouring openings
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
- B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
- B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
- B65D81/32—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents for packaging two or more different materials which must be maintained separate prior to use in admixture
- B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
- B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS 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
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
- A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
- A61J1/202—Separating means
- A61J1/2041—Separating means having removable plugs
Abstract
A drug container is sealed by an annular packing arranged at an open end of a container body, a spherical closing member held on the annular packing, and a cap-like holder fitted on the mouth portion of the container body. In use, the drug container is screwed into a solvent container assembly having a partition wall with a push rod. The spherical closing member is pushed out from the packing by the push rod and then the partition wall is broken by the holder of the drug container to interconnect the container body with the solvent container.
Description
t,,r.w,, DRUG CONTAINER AND DUAL CONTAINER SYSTEM FOR FLUID THERAPY
EMPLOYING THE SAME
The present invention relates to a drug container suitable for aseptically mixing a drug contained therein with a solvent or a diluent contained in another container, and to a dual container system for fluid therapy employing the same.
In medical facilities, such as hospitals, some drugs are mixed with a solvent or a diluent just before use to prepare a parenteral fluid for intravenous drip infusion. Such drugs are generally supplied in the form of a powder or a freeze-dried preparation and are packaged in a drug container or a vial because of their poor conservation stability in the liquid state, or for one or more other reasons. It is therefore required to mix the drug in the container or vial with a solvent or diluent in another container. The drug container or vial is usually connected to the solvent container by suitable connecting means, such as, for example, a double ended needle or a connecting tube to transfer the solvent or diluent to the drug container. However, such procedures are often troublesome and time-consuming. In addition, there is a fear of contamination of the drug, as it is required to make a hole in a stopper of the drug container in air to connect it with the solvent container.
To solve such problems, there have been proposed various drug delivery systems. For example, JP-T- S61-501129, corresponding to U.S. Patent 4,583,971, discloses a closed drug delivery system comprising a flexible container having a liquid diluent therein, a capsule coupled to the flexible container, a drug vial having a drug therein, which is 3o supported in the capsule, and means for coupling the capsule to the interior of the flexible container. In this system, the drug vial is caused to communicate with the flexible container through communicating means arranged in the coupling means, thus making it possible to aseptically mix the drug with the solvent.
t,"''~".
, . 2076773 _- U.S. Patent 4,936,841 (corresponding to JP-A- H2-1277) discloses a container system comprising a flexible container containing a diluent, a capsule having a cylindrical connecting portion at one end, while being connected to a mouth portion of the flexible container at the connecting portion, a drug container held in the capsule, and communicating means arranged in the capsule to form a passage interconnecting the flexible container with the drug container. In this system, the communicating means is firstly pierced into the drug vial and then into the flexible container to connect the flexible container with the drug container. Since the flexible container is connected with the drug container in a closed system, it is possible to aseptically mix the drug with the solvent.
JP-A- H3-37067 discloses a container for an infusion fluid comprising a bag of thermoplastic resin, a drug vial held in the bag in the inverted state, a liquid container containing a diluent, a flexible cylindrical member connected to the bag at one end and to the liquid container at the other end, communicating means arranged between the drug container and the liquid container and housed in the cylindrical member, and means for supporting the drug container and the liquid container, the supporting means being between the drug vial and the liquid container to prevent the two containers from being too close to each other until the aseptic communicating and mixing operations have been completed.
However, it is impossible with these three systems to change the combination of the drug and solvent or diluent, as the drug vial is paired with the liquid container.
JP-A- S59-209535, corresponding to U.S. Patent Serial No. 470,105 filed February 28, 1983 and Serial No. 565,126 filed December 23, 1983, discloses a drug delivery system comprising a first flexible container having an opening at one end, a second container having a removable stopper and being capable of being fixed to the bottom wall of the first container, and stopper removing means having a portion engaging the stopper. JP-B- H2-26506, corresponding to U.S.
. - 3 -Patent Serial No. 590,601 filed March 19, 1984, discloses an improved drug delivery system having a structure similar to that of JP-A- S59-209535. Also, JP-A- S62-137056 (corresponding to U.S. Serial No. 806,782 filed December 9, 1985) and H2-4375 (corresponding to U.S. Serial No. 138,810 filed December 28, 1987) discloses an improved drug container for use in the drug delivery system of JP-A- S59-209535.
These drug delivery systems make it possible to perform substantially aseptic operations, as well as to optionally select the combination of a drug with a solvent or diluent as occasion demands.
However, these drug delivery systems are complex in structure and may give a patient an uneasy feeling when the stopper of the drug container is dropped into the liquid container.
It is therefore an object of the present invention to provide a drug container that is simple in structure and enables aseptical mixing of a drug contained therein with a solvent or diluent contained in a separate solvent container without causing a stopper to drop into the solvent container.
Another object of the present invention is to provide a dual container system for fluid therapy, that enables aseptical performance of all operations of the preparation and delivery procedure of a parenteral fluid or a liquid medicine.
The above and other objects of the present invention are achieved by providing a drug container comprising a bottle-shaped container body, means for sealing an open end of the container body, and a covering member for covering at least the sealing means and a mouth portion of said container body, characterized in that the container body is provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof, and that the sealing means comprises an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the body and being held on the seat of the container body, a spherical closing member having a diameter larger than the inside y - 4 -.' diameter of the packing, but smaller than the inside diameter of the seat, and being held on the packing to close the bore - of the packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place.
In a preferred embodiment, the covering member comprises a cap-like member partially enlarged in diameter at its open end to form an enlarged skirt portion. This cap-like member is placed on the mouth portion of the container body and fixed thereto at its enlarged skirt portion.
In another preferred embodiment, the covering member comprises a synthetic resin sheet covering the whole of the drug container.
According to the present invention, there is also provided a dual container system for fluid therapy, which comprises first and second containers separate from one another, the first container containing a dose of a drug and comprising a bottle-shaped container body provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof: means for sealing the open end of the container body; and a covering member for covering at least the sealing means and a mouth portion of the container body; the sealing means comprising an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the container body and being held on the seat of said container body, a spherical closing member having a diameter larger than the inside diameter of the packing, but smaller than the inside diameter of the seat and being held on the packing to close the bore of said packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place, and the second container containing a dose of a solvent or diluent and comprising a solvent container having a mouth portion at either end and being closed at one mouth portion thereof by a rubber stopper: and a cylindrical connecting member for connecting the solvent container to the first . - 5 -.' container, said cylindrical connecting member being connected at one end to the other mouth portion of the solvent container and sealed at its opposite end by a sealing member.
In a preferred embodiment, the connecting member has means for engagement with the first container on an inside wall thereof, a partition wall integrally connected thereto near one end thereof where the solvent container is connected, and a push rod extending coaxially from the central portion of the partition wall towards the opposite end of the connecting member. A hollow portion defined by the inside wall and the partition wall of the connecting member has a configuration corresponding to that of the mouth portion of the first container. The partition wall is provided with an annular brittle portion coaxially around the push rod to make the partition wall easily breakable. Also, several grooves are formed in both sides of the partition wall to provide passages for fluid extending radially from the base of the push rod towards the brittle portion.
These and other objects, features and advantages of the present invention will become apparent from the following description taken in conjunction with the preferred embodiments thereof with reference to the accompanying drawings in which like parts are designated by like reference numerals throughout the drawings.
Fig. 1 is a cross-section view of a drug container showing one embodiment of the present invention:
Fig. 2 is a cross-sectional view of a solvent container assembly to be used in combination with the drug container of Fig. 1; and Fig. 3 is a cross-section of a dual container system for fluid therapy comprising the drug container of Fig. 1 and the solvent container assembly of Fig. 2, illustrating the use thereof.
Referring to Fig. 1, there is shown a drug container V
that comprises a container body 1, an annular packing 2 arranged on the inside wall of a mouth portion 8 of the body 1, a spherical closing member 3 held on the packing 2, A
. ,~
, _. - 6 - 2076773 s a holder 4 fitted on the mouth portion 8 of the body 1 to hold the spherical closing member 3 in place, and a covering member 5 fixed to the body 1 to cover the holder 4 and the outside wall of the mouth portion 8.
The container body 1 is a bottle-shaped container, or a bottom-closed cylindrical member reduced in diameter at its open end to form a narrow mouth portion. Preferably, the container body 1 is made of a transparent material, such as, for example, glass or a synthetic resin, including polypropylene resins and polyester. The mouth portion 8 of the container body 1 is provided with connecting means (generally a male screw) 6 and sealing member (generally an O-ring) 7 to firmly connect the container body 1 in a fluid tight manner with a solvent container assembly S described later. Around the mouth portion 8 there may be provided a circumferential groove for holding the sealing member 7.
In the inside wall of the mouth portion 8 of the container body 1 and close to its open end, there is an annular seat 9 to hold the packing 2. The packing seat 9 may be formed by providing an inwardly extending annular projection on the inside wall of the mouth portion, or by providing an upwardly extending annular projection on the open end of the mouth portion. The packing seat 9 may take any shape, provided that it can hold the packing 2 in place and prevent it from falling off even when an external force is applied to the packing 2 in a direction perpendicular to the seat 9.
The container body 1 is provided with an annular groove 15 adjacent the open end of the mouth portion 8 to provide means for engagement with the holder 4.
The packing 2 is made of an elastomeric material, such as butyl rubber, styrene-butadiene rubber, isoprene rubber, urethane rubber, and nitrile rubber in the form of an annular member or a disk-like member with a central bore that has a diameter smaller than that of the spherical closing member 3.
The spherical closing member 3 has a diameter smaller than the inside diameter of the mouth portion 8, but larger ~ - ~ -.' The spherical closing member 3 has a diameter smaller than the inside diameter of the mouth portion 8, but larger . than the inside diameter of the packing 2. The member 3 is generally made of glass or a synthetic resin. However, the member 3 may be made of any other material, provided that it has good chemical-resistance and provides a smooth surface.
This member 3 may be used in combination with a thick cylindrical packing having a spherical bore therein to hold it in place.
The holder 4 is a cap-like member and is generally made of a flexible resin. Typical flexible resins as the material for the holder include, without being limited to, poly-propylene, polyethylene, polycarbonate, polyesters, polyvinyl chlorides and the like. At the central part of the top wall of the holder 4, there is a bore having a diameter smaller than that of the spherical closing member 3 to allow a push rod of the solvent container assembly to pass therethrough when connecting the drug container to the solvent container assembly. At its lower end the holder 4 has an inwardly extending rib 11 to engage the flange 10 of the body 1. The holder 4 is snapped onto the mouth portion 8 of the container body 1 to hold the spherical closing member 3 in place as well as to press it against the packing 2.
The covering member 5 is in the form of a cap or a cylindrical member closed at one end and open at the other.
The end of the skirt portion (side wall) of the covering member 5 is enlarged in diameter to form an enlarged skirt portion 13, at which location the member 5 is fixed to the body 1 to protect the sealing means (2, 3, 4) and the mouth portion 8 of the container body 1 from contamination with bacteria. The covering member 5 is provided with upwardly extending projections 14 spaced equally round the circumference of the enlarged skirt portion 13. Adjacent the enlarged skirt portion 13, the member 5 is provided with a brittle or friable portion 12 to allow the member 5 to be twisted off easily by turning, while leaving the enlarged skirt portion 13 on the body 1. The projections 14 are 2p~6)73 r _8_ provided to prevent the drug container V from any looseness in relation to its screw connection with the solvent container assembly S.
The drug container V may be used in combination with a solvent container assembly S shown in Fig. 2.
Referring now to Fig. 2, the solvent container assembly S
comprises a solvent container 21 containing a dose of a solvent or diluent, a cylindrical connecting member 22, and a sealing member 23 used for sealing an open end 36 of the connecting member 32.
The solvent container 21 is a bottle-shaped container having a mouth portion 25, 29 at each end. The mouth portion 29 at the bottom of the solvent container serves as an outlet for the solution prepared by mixing the drug and the solvent. The solvent container 21 may take any other shape and configuration as occasion demands. The mouth portion 29 is sealed by a rubber stopper 28.
The connecting member 22 is a cylindrical hollow body and is enlarged in diameter on its upper end so that it has a hollow portion having a configuration corresponding to that of the mouth portion 8 of the drug container V. On the inside wall of the connecting member 22, there is a female screw 24 to engage the male screw 6 of the drug container V. At its lower end the connecting member 22 has a flange 35 fixed to a flange 26 of the mouth portion 25 of the solvent container 21.
The lower end of the connecting member 22 is closed by a partition wall 30 integrally connected thereto near the flange 35. The partition wall 30 has a push rod 31 extending coaxially with the member 22 in the direction toward the upper open end 36 of the member 22. Also, the partition wall 30 has an annular brittle or friable portion 32 formed coaxially with the push rod 31 to allow the partition wall 30 to be easily broken by the holder 4 of the drug container V when the solvent container assembly S is screwed thereon.
The partition wall 30 is provided on both sides with several grooves (not shown) radially extending from the base of the push rod 31 towards the brittle portion 32 to form A
" ' r""'w"' _ g _ ,' passages for the solvent when the partition wall 30 comes into contact with the flange 26 of the solvent container 21 or the holder 4 of the drug container V. As illustrated in Fig. 2, however, when the partition wall 30 has an annular rib 33 surrounding the push rod 31, it is sufficient to provide several grooves or cuts in the annular rib 33, instead of the grooves being formed in the upper surface of the partition wall 30. The connecting member 22 is further provided with a plurality of projections 34 adapted to engage the projections 14 of the enlarged skirt portion 13 remained on the body 1. The upper open end 36 of the connecting member 22 is sealed by suitable sealing means, such as, for example, a laminated film 23 of aluminum foil with polyester as the external layers.
In general, the drug container V and the solvent container assembly S are separately packaged in a suitable plastic sheet to keep them in a sterile condition until just before use.
These two containers are combined with each other to constitute a liquid transfusion system or a dual container system for fluid therapy.
To make the dual container system ready for use, the covering member 5 is twisted off from the drug container V by turning it clockwise or counterclockwise, while leaving the enlarged skirt portion 13 of the covering member 5 on the container V. Also, the laminated film 23 of the solvent container assembly S is peeled off from the connecting member 22.
The solvent container assembly S is then connected to the drug container V by screwing the connecting member 22 onto the mouth portion 8 of the drug container V. During this operation, the spherical closing member 3 is forced out of the packing 2 and dropped into the drug container V by the push rod 31 of the member 22. By further screwing the solvent container assembly S, the holder 4 is brought into contact with the annular projection 33 on the partition wall 30 of the solvent container assembly S, so that the partition wall 30 is A
,' pressed towards the solvent container 21 and then broken at the brittle portion 32, as shown in Fig. 3. At the same time, . the container body 1 is brought into communication with the solvent container 21 through the broken part and the grooves formed in the partition wall 30. Also, the clearance between the mouth portion 8 of the drug container V and the inside wall of the connecting member 22 is sealed by the sealing member 7.
The assembled dual container system is now turned upside down to allow the solvent in the solvent container 21 to flow into the container body 1 through the broken part and the grooves in the partition wall 30, shaken to prepare a homogeneous solution, and then turned upside down again to allow the solution in the body 1 to flow into the container 21. The resultant solution may be used for an intravenous drip infusion by connecting the mouth portion 29 of the container 21 to an infusion set.
As will be understood from the above, according to the present invention, it is possible to provide a drug container that is simple in construction, easy to handle, and low in manufacturing cost, while enabling aseptic operation. Also, the present invention provides a drug transfusion system that makes it possible to arbitrarily determine the combination of the drug container and the solvent container as occasion demands. In addition, use of the drug container of the present invention places a patient at ease, since the stopper is prevented from falling into the solvent container.
Although the present invention has been fully described in connection with the preferred embodiments thereof with reference to the accompanying drawings, it is to be noted that various changes and modifications are apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims unless they depart therefrom.
n
EMPLOYING THE SAME
The present invention relates to a drug container suitable for aseptically mixing a drug contained therein with a solvent or a diluent contained in another container, and to a dual container system for fluid therapy employing the same.
In medical facilities, such as hospitals, some drugs are mixed with a solvent or a diluent just before use to prepare a parenteral fluid for intravenous drip infusion. Such drugs are generally supplied in the form of a powder or a freeze-dried preparation and are packaged in a drug container or a vial because of their poor conservation stability in the liquid state, or for one or more other reasons. It is therefore required to mix the drug in the container or vial with a solvent or diluent in another container. The drug container or vial is usually connected to the solvent container by suitable connecting means, such as, for example, a double ended needle or a connecting tube to transfer the solvent or diluent to the drug container. However, such procedures are often troublesome and time-consuming. In addition, there is a fear of contamination of the drug, as it is required to make a hole in a stopper of the drug container in air to connect it with the solvent container.
To solve such problems, there have been proposed various drug delivery systems. For example, JP-T- S61-501129, corresponding to U.S. Patent 4,583,971, discloses a closed drug delivery system comprising a flexible container having a liquid diluent therein, a capsule coupled to the flexible container, a drug vial having a drug therein, which is 3o supported in the capsule, and means for coupling the capsule to the interior of the flexible container. In this system, the drug vial is caused to communicate with the flexible container through communicating means arranged in the coupling means, thus making it possible to aseptically mix the drug with the solvent.
t,"''~".
, . 2076773 _- U.S. Patent 4,936,841 (corresponding to JP-A- H2-1277) discloses a container system comprising a flexible container containing a diluent, a capsule having a cylindrical connecting portion at one end, while being connected to a mouth portion of the flexible container at the connecting portion, a drug container held in the capsule, and communicating means arranged in the capsule to form a passage interconnecting the flexible container with the drug container. In this system, the communicating means is firstly pierced into the drug vial and then into the flexible container to connect the flexible container with the drug container. Since the flexible container is connected with the drug container in a closed system, it is possible to aseptically mix the drug with the solvent.
JP-A- H3-37067 discloses a container for an infusion fluid comprising a bag of thermoplastic resin, a drug vial held in the bag in the inverted state, a liquid container containing a diluent, a flexible cylindrical member connected to the bag at one end and to the liquid container at the other end, communicating means arranged between the drug container and the liquid container and housed in the cylindrical member, and means for supporting the drug container and the liquid container, the supporting means being between the drug vial and the liquid container to prevent the two containers from being too close to each other until the aseptic communicating and mixing operations have been completed.
However, it is impossible with these three systems to change the combination of the drug and solvent or diluent, as the drug vial is paired with the liquid container.
JP-A- S59-209535, corresponding to U.S. Patent Serial No. 470,105 filed February 28, 1983 and Serial No. 565,126 filed December 23, 1983, discloses a drug delivery system comprising a first flexible container having an opening at one end, a second container having a removable stopper and being capable of being fixed to the bottom wall of the first container, and stopper removing means having a portion engaging the stopper. JP-B- H2-26506, corresponding to U.S.
. - 3 -Patent Serial No. 590,601 filed March 19, 1984, discloses an improved drug delivery system having a structure similar to that of JP-A- S59-209535. Also, JP-A- S62-137056 (corresponding to U.S. Serial No. 806,782 filed December 9, 1985) and H2-4375 (corresponding to U.S. Serial No. 138,810 filed December 28, 1987) discloses an improved drug container for use in the drug delivery system of JP-A- S59-209535.
These drug delivery systems make it possible to perform substantially aseptic operations, as well as to optionally select the combination of a drug with a solvent or diluent as occasion demands.
However, these drug delivery systems are complex in structure and may give a patient an uneasy feeling when the stopper of the drug container is dropped into the liquid container.
It is therefore an object of the present invention to provide a drug container that is simple in structure and enables aseptical mixing of a drug contained therein with a solvent or diluent contained in a separate solvent container without causing a stopper to drop into the solvent container.
Another object of the present invention is to provide a dual container system for fluid therapy, that enables aseptical performance of all operations of the preparation and delivery procedure of a parenteral fluid or a liquid medicine.
The above and other objects of the present invention are achieved by providing a drug container comprising a bottle-shaped container body, means for sealing an open end of the container body, and a covering member for covering at least the sealing means and a mouth portion of said container body, characterized in that the container body is provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof, and that the sealing means comprises an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the body and being held on the seat of the container body, a spherical closing member having a diameter larger than the inside y - 4 -.' diameter of the packing, but smaller than the inside diameter of the seat, and being held on the packing to close the bore - of the packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place.
In a preferred embodiment, the covering member comprises a cap-like member partially enlarged in diameter at its open end to form an enlarged skirt portion. This cap-like member is placed on the mouth portion of the container body and fixed thereto at its enlarged skirt portion.
In another preferred embodiment, the covering member comprises a synthetic resin sheet covering the whole of the drug container.
According to the present invention, there is also provided a dual container system for fluid therapy, which comprises first and second containers separate from one another, the first container containing a dose of a drug and comprising a bottle-shaped container body provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof: means for sealing the open end of the container body; and a covering member for covering at least the sealing means and a mouth portion of the container body; the sealing means comprising an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the container body and being held on the seat of said container body, a spherical closing member having a diameter larger than the inside diameter of the packing, but smaller than the inside diameter of the seat and being held on the packing to close the bore of said packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place, and the second container containing a dose of a solvent or diluent and comprising a solvent container having a mouth portion at either end and being closed at one mouth portion thereof by a rubber stopper: and a cylindrical connecting member for connecting the solvent container to the first . - 5 -.' container, said cylindrical connecting member being connected at one end to the other mouth portion of the solvent container and sealed at its opposite end by a sealing member.
In a preferred embodiment, the connecting member has means for engagement with the first container on an inside wall thereof, a partition wall integrally connected thereto near one end thereof where the solvent container is connected, and a push rod extending coaxially from the central portion of the partition wall towards the opposite end of the connecting member. A hollow portion defined by the inside wall and the partition wall of the connecting member has a configuration corresponding to that of the mouth portion of the first container. The partition wall is provided with an annular brittle portion coaxially around the push rod to make the partition wall easily breakable. Also, several grooves are formed in both sides of the partition wall to provide passages for fluid extending radially from the base of the push rod towards the brittle portion.
These and other objects, features and advantages of the present invention will become apparent from the following description taken in conjunction with the preferred embodiments thereof with reference to the accompanying drawings in which like parts are designated by like reference numerals throughout the drawings.
Fig. 1 is a cross-section view of a drug container showing one embodiment of the present invention:
Fig. 2 is a cross-sectional view of a solvent container assembly to be used in combination with the drug container of Fig. 1; and Fig. 3 is a cross-section of a dual container system for fluid therapy comprising the drug container of Fig. 1 and the solvent container assembly of Fig. 2, illustrating the use thereof.
Referring to Fig. 1, there is shown a drug container V
that comprises a container body 1, an annular packing 2 arranged on the inside wall of a mouth portion 8 of the body 1, a spherical closing member 3 held on the packing 2, A
. ,~
, _. - 6 - 2076773 s a holder 4 fitted on the mouth portion 8 of the body 1 to hold the spherical closing member 3 in place, and a covering member 5 fixed to the body 1 to cover the holder 4 and the outside wall of the mouth portion 8.
The container body 1 is a bottle-shaped container, or a bottom-closed cylindrical member reduced in diameter at its open end to form a narrow mouth portion. Preferably, the container body 1 is made of a transparent material, such as, for example, glass or a synthetic resin, including polypropylene resins and polyester. The mouth portion 8 of the container body 1 is provided with connecting means (generally a male screw) 6 and sealing member (generally an O-ring) 7 to firmly connect the container body 1 in a fluid tight manner with a solvent container assembly S described later. Around the mouth portion 8 there may be provided a circumferential groove for holding the sealing member 7.
In the inside wall of the mouth portion 8 of the container body 1 and close to its open end, there is an annular seat 9 to hold the packing 2. The packing seat 9 may be formed by providing an inwardly extending annular projection on the inside wall of the mouth portion, or by providing an upwardly extending annular projection on the open end of the mouth portion. The packing seat 9 may take any shape, provided that it can hold the packing 2 in place and prevent it from falling off even when an external force is applied to the packing 2 in a direction perpendicular to the seat 9.
The container body 1 is provided with an annular groove 15 adjacent the open end of the mouth portion 8 to provide means for engagement with the holder 4.
The packing 2 is made of an elastomeric material, such as butyl rubber, styrene-butadiene rubber, isoprene rubber, urethane rubber, and nitrile rubber in the form of an annular member or a disk-like member with a central bore that has a diameter smaller than that of the spherical closing member 3.
The spherical closing member 3 has a diameter smaller than the inside diameter of the mouth portion 8, but larger ~ - ~ -.' The spherical closing member 3 has a diameter smaller than the inside diameter of the mouth portion 8, but larger . than the inside diameter of the packing 2. The member 3 is generally made of glass or a synthetic resin. However, the member 3 may be made of any other material, provided that it has good chemical-resistance and provides a smooth surface.
This member 3 may be used in combination with a thick cylindrical packing having a spherical bore therein to hold it in place.
The holder 4 is a cap-like member and is generally made of a flexible resin. Typical flexible resins as the material for the holder include, without being limited to, poly-propylene, polyethylene, polycarbonate, polyesters, polyvinyl chlorides and the like. At the central part of the top wall of the holder 4, there is a bore having a diameter smaller than that of the spherical closing member 3 to allow a push rod of the solvent container assembly to pass therethrough when connecting the drug container to the solvent container assembly. At its lower end the holder 4 has an inwardly extending rib 11 to engage the flange 10 of the body 1. The holder 4 is snapped onto the mouth portion 8 of the container body 1 to hold the spherical closing member 3 in place as well as to press it against the packing 2.
The covering member 5 is in the form of a cap or a cylindrical member closed at one end and open at the other.
The end of the skirt portion (side wall) of the covering member 5 is enlarged in diameter to form an enlarged skirt portion 13, at which location the member 5 is fixed to the body 1 to protect the sealing means (2, 3, 4) and the mouth portion 8 of the container body 1 from contamination with bacteria. The covering member 5 is provided with upwardly extending projections 14 spaced equally round the circumference of the enlarged skirt portion 13. Adjacent the enlarged skirt portion 13, the member 5 is provided with a brittle or friable portion 12 to allow the member 5 to be twisted off easily by turning, while leaving the enlarged skirt portion 13 on the body 1. The projections 14 are 2p~6)73 r _8_ provided to prevent the drug container V from any looseness in relation to its screw connection with the solvent container assembly S.
The drug container V may be used in combination with a solvent container assembly S shown in Fig. 2.
Referring now to Fig. 2, the solvent container assembly S
comprises a solvent container 21 containing a dose of a solvent or diluent, a cylindrical connecting member 22, and a sealing member 23 used for sealing an open end 36 of the connecting member 32.
The solvent container 21 is a bottle-shaped container having a mouth portion 25, 29 at each end. The mouth portion 29 at the bottom of the solvent container serves as an outlet for the solution prepared by mixing the drug and the solvent. The solvent container 21 may take any other shape and configuration as occasion demands. The mouth portion 29 is sealed by a rubber stopper 28.
The connecting member 22 is a cylindrical hollow body and is enlarged in diameter on its upper end so that it has a hollow portion having a configuration corresponding to that of the mouth portion 8 of the drug container V. On the inside wall of the connecting member 22, there is a female screw 24 to engage the male screw 6 of the drug container V. At its lower end the connecting member 22 has a flange 35 fixed to a flange 26 of the mouth portion 25 of the solvent container 21.
The lower end of the connecting member 22 is closed by a partition wall 30 integrally connected thereto near the flange 35. The partition wall 30 has a push rod 31 extending coaxially with the member 22 in the direction toward the upper open end 36 of the member 22. Also, the partition wall 30 has an annular brittle or friable portion 32 formed coaxially with the push rod 31 to allow the partition wall 30 to be easily broken by the holder 4 of the drug container V when the solvent container assembly S is screwed thereon.
The partition wall 30 is provided on both sides with several grooves (not shown) radially extending from the base of the push rod 31 towards the brittle portion 32 to form A
" ' r""'w"' _ g _ ,' passages for the solvent when the partition wall 30 comes into contact with the flange 26 of the solvent container 21 or the holder 4 of the drug container V. As illustrated in Fig. 2, however, when the partition wall 30 has an annular rib 33 surrounding the push rod 31, it is sufficient to provide several grooves or cuts in the annular rib 33, instead of the grooves being formed in the upper surface of the partition wall 30. The connecting member 22 is further provided with a plurality of projections 34 adapted to engage the projections 14 of the enlarged skirt portion 13 remained on the body 1. The upper open end 36 of the connecting member 22 is sealed by suitable sealing means, such as, for example, a laminated film 23 of aluminum foil with polyester as the external layers.
In general, the drug container V and the solvent container assembly S are separately packaged in a suitable plastic sheet to keep them in a sterile condition until just before use.
These two containers are combined with each other to constitute a liquid transfusion system or a dual container system for fluid therapy.
To make the dual container system ready for use, the covering member 5 is twisted off from the drug container V by turning it clockwise or counterclockwise, while leaving the enlarged skirt portion 13 of the covering member 5 on the container V. Also, the laminated film 23 of the solvent container assembly S is peeled off from the connecting member 22.
The solvent container assembly S is then connected to the drug container V by screwing the connecting member 22 onto the mouth portion 8 of the drug container V. During this operation, the spherical closing member 3 is forced out of the packing 2 and dropped into the drug container V by the push rod 31 of the member 22. By further screwing the solvent container assembly S, the holder 4 is brought into contact with the annular projection 33 on the partition wall 30 of the solvent container assembly S, so that the partition wall 30 is A
,' pressed towards the solvent container 21 and then broken at the brittle portion 32, as shown in Fig. 3. At the same time, . the container body 1 is brought into communication with the solvent container 21 through the broken part and the grooves formed in the partition wall 30. Also, the clearance between the mouth portion 8 of the drug container V and the inside wall of the connecting member 22 is sealed by the sealing member 7.
The assembled dual container system is now turned upside down to allow the solvent in the solvent container 21 to flow into the container body 1 through the broken part and the grooves in the partition wall 30, shaken to prepare a homogeneous solution, and then turned upside down again to allow the solution in the body 1 to flow into the container 21. The resultant solution may be used for an intravenous drip infusion by connecting the mouth portion 29 of the container 21 to an infusion set.
As will be understood from the above, according to the present invention, it is possible to provide a drug container that is simple in construction, easy to handle, and low in manufacturing cost, while enabling aseptic operation. Also, the present invention provides a drug transfusion system that makes it possible to arbitrarily determine the combination of the drug container and the solvent container as occasion demands. In addition, use of the drug container of the present invention places a patient at ease, since the stopper is prevented from falling into the solvent container.
Although the present invention has been fully described in connection with the preferred embodiments thereof with reference to the accompanying drawings, it is to be noted that various changes and modifications are apparent to those skilled in the art. Such changes and modifications are to be understood as included within the scope of the present invention as defined by the appended claims unless they depart therefrom.
n
Claims (6)
1. A drug container comprising a bottle-shaped container body, means for sealing an open end of the container body, and a covering member for covering at least the sealing means and a mouth portion of the container body, characterized in that the container body is provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof, and that the sealing means comprises an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the container body and being held on the seat of the container body, a spherical closing member having a diameter larger than the inside diameter of the packing, but smaller than the inside diameter of the seat and being held on the packing to close the bore of the packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place.
2. The drug container according to claim 1 wherein said covering member is a cap.
3. The drug container according to claim 1 wherein said covering member is a synthetic resin sheet covering the whole of the container.
4. A dual container system for fluid therapy comprising first and second containers separate from one another, the first container containing a dose of a drug and comprising a bottle-shaped container body provided with connecting means and sealing member on the outside wall of a mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof, means for sealing the open end of the container body, and a covering member for covering at least the sealing means and a mouth portion of said container body, the sealing means comprising an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of the container body and being held on the seat of said container body, a spherical closing member having a diameter larger than the inside diameter of the packing, but smaller than the inside diameter of the seat and being held on the packing to close the bore of the packing, and a cap-like holder fitted on the mouth portion of the container body to hold the spherical closing member in place:
the second container containing a dose of a solvent or diluent and comprising a solvent container having a mouth portion at each end and being closed at one mouth portion thereof by a rubber stopper, and a cylindrical connecting member for connecting the solvent container to the first container, the cylindrical connecting member being connected at one end thereof to the other mouth portion of the solvent container and sealed at the opposite end by a sealing member.
the second container containing a dose of a solvent or diluent and comprising a solvent container having a mouth portion at each end and being closed at one mouth portion thereof by a rubber stopper, and a cylindrical connecting member for connecting the solvent container to the first container, the cylindrical connecting member being connected at one end thereof to the other mouth portion of the solvent container and sealed at the opposite end by a sealing member.
5. The dual container system for fluid therapy according to claim 4 wherein the connecting member has means for engagement with the first container on an inside wall thereof, a partition wall integrally connected thereto near one end thereof where the solvent container is connected thereto, and a push rod extending from the central portion of the partition wall towards the opposite end of the connecting member, said partition wall having an annular brittle portion formed coaxially around the push rod, and several grooves formed in its sides to provide passages extending radially from the base of the push rod towards the brittle portion.
6. The dual container system for fluid therapy according to claim 5 wherein the engagement means comprises a female screw provided on the inside wall of the connecting member and adapted to be engaged with a male screw provided on the mouth portion of said drug container.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3-244562 | 1991-08-29 | ||
| JP24456291A JP3065735B2 (en) | 1991-08-29 | 1991-08-29 | Drug container and drug solution injector using the same |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2076773A1 CA2076773A1 (en) | 1993-03-01 |
| CA2076773C true CA2076773C (en) | 2002-06-04 |
Family
ID=17120565
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2076773 Expired - Fee Related CA2076773C (en) | 1991-08-29 | 1992-08-25 | Drug container and dual container system for fluid therapy employing the same |
Country Status (7)
| Country | Link |
|---|---|
| US (1) | US5342347A (en) |
| EP (1) | EP0529595B1 (en) |
| JP (1) | JP3065735B2 (en) |
| KR (1) | KR100201014B1 (en) |
| CA (1) | CA2076773C (en) |
| DE (1) | DE69206354T2 (en) |
| ES (1) | ES2080397T3 (en) |
Families Citing this family (26)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5928935A (en) * | 1995-09-26 | 1999-07-27 | Reuss, Jr.; William Alexander | Biological specimen containment and incubation device |
| US6042605A (en) | 1995-12-14 | 2000-03-28 | Gore Enterprose Holdings, Inc. | Kink resistant stent-graft |
| US5817082A (en) * | 1996-11-08 | 1998-10-06 | Bracco Diagnostics Inc. | Medicament container closure with integral spike access means |
| US5895383A (en) * | 1996-11-08 | 1999-04-20 | Bracco Diagnostics Inc. | Medicament container closure with recessed integral spike access means |
| US6050935A (en) * | 1997-05-09 | 2000-04-18 | Biofertec | Container assembly for intravaginal fertilization and culture and embryo transfer and method of intravaginal fertilization and culture employing such a container |
| US6090092A (en) | 1997-12-04 | 2000-07-18 | Baxter International Inc. | Sliding reconstitution device with seal |
| US6719779B2 (en) | 2000-11-07 | 2004-04-13 | Innercool Therapies, Inc. | Circulation set for temperature-controlled catheter and method of using the same |
| US6383210B1 (en) | 2000-06-02 | 2002-05-07 | Innercool Therapies, Inc. | Method for determining the effective thermal mass of a body or organ using cooling catheter |
| US6585752B2 (en) | 1998-06-23 | 2003-07-01 | Innercool Therapies, Inc. | Fever regulation method and apparatus |
| US6022339A (en) | 1998-09-15 | 2000-02-08 | Baxter International Inc. | Sliding reconstitution device for a diluent container |
| AR021220A1 (en) | 1998-09-15 | 2002-07-03 | Baxter Int | CONNECTION DEVICE FOR ESTABLISHING A FLUID COMMUNICATION BETWEEN A FIRST CONTAINER AND A SECOND CONTAINER. |
| US7425209B2 (en) | 1998-09-15 | 2008-09-16 | Baxter International Inc. | Sliding reconstitution device for a diluent container |
| FR2783808B1 (en) | 1998-09-24 | 2000-12-08 | Biodome | CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE |
| JP4617552B2 (en) * | 1999-09-30 | 2011-01-26 | アステラス製薬株式会社 | Infusion container and lyophilized drug storage method |
| FR2802183B1 (en) * | 1999-12-10 | 2002-02-22 | Biodome | METHOD FOR MANUFACTURING A CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER, CORRESPONDING CONNECTION DEVICE AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE |
| FR2810639B1 (en) | 2000-06-21 | 2002-09-06 | Oreal | SET FOR THE EXTEMPORANEOUS MIXTURE OF TWO PRODUCTS |
| FR2815328B1 (en) * | 2000-10-17 | 2002-12-20 | Biodome | CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE |
| US6719723B2 (en) | 2000-12-06 | 2004-04-13 | Innercool Therapies, Inc. | Multipurpose catheter assembly |
| FR2836129B1 (en) * | 2002-02-20 | 2004-04-02 | Biodome | CONNECTION DEVICE BETWEEN A CONTAINER AND A CONTAINER AND READY-TO-USE ASSEMBLY COMPRISING SUCH A DEVICE |
| US8562583B2 (en) | 2002-03-26 | 2013-10-22 | Carmel Pharma Ab | Method and assembly for fluid transfer and drug containment in an infusion system |
| US7641851B2 (en) | 2003-12-23 | 2010-01-05 | Baxter International Inc. | Method and apparatus for validation of sterilization process |
| KR101210987B1 (en) * | 2009-10-26 | 2012-12-11 | 주식회사 엘지화학 | Inkjet composition for forming transparent film and preparation methode thereof |
| CN104138331A (en) * | 2013-05-10 | 2014-11-12 | 马蕾 | Medicine bottle cap |
| EA201890069A1 (en) | 2015-06-16 | 2018-06-29 | Бёрингер Ингельхайм Ветмедика Гмбх | SYSTEM OF CAPACITIES AND THEIR CONNECTIONS |
| BR122020015022B1 (en) | 2015-06-16 | 2023-04-11 | Boehringer Ingelheim Vetmedica Gmbh | CONNECTION ARRANGEMENT, METHOD FOR PRODUCING THE CONNECTION ARRANGEMENT, USE OF THE CONNECTION ARRANGEMENT AND CONTAINER WITH A CONNECTION ARRANGEMENT |
| AU2016279559B2 (en) | 2015-06-16 | 2020-07-30 | Boehringer Ingelheim Vetmedica Gmbh | Connecting and container system |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US611520A (en) * | 1898-09-27 | Bottle for holding spirits or other liquids and aerated waters | ||
| US2653609A (en) * | 1950-08-26 | 1953-09-29 | Arthur E Smith | Container closure |
| US2659370A (en) * | 1950-08-26 | 1953-11-17 | Arthur E Smith | Closure |
| US2636493A (en) * | 1950-12-22 | 1953-04-28 | Compule Corp | Mixing container for segregated ingredients of therapeutic preparations |
| FR2188565A5 (en) * | 1972-06-13 | 1974-01-18 | Semco Emballage Conditio | |
| US4614267A (en) * | 1983-02-28 | 1986-09-30 | Abbott Laboratories | Dual compartmented container |
| US4583971A (en) * | 1984-02-10 | 1986-04-22 | Travenol European Research And Development Centre (Teradec) | Closed drug delivery system |
| US4757911A (en) * | 1985-12-09 | 1988-07-19 | Abbott Laboratories | Container and closure construction |
| JPH021277A (en) * | 1988-03-31 | 1990-01-05 | Fujisawa Pharmaceut Co Ltd | Infusion container |
| JPH0740970B2 (en) * | 1988-07-15 | 1995-05-10 | 株式会社ノダ | Storage shelf equipment |
| EP0462255B1 (en) * | 1990-01-08 | 1994-09-21 | Becton Dickinson France S.A. | Two-compartment storage and transfer flask |
-
1991
- 1991-08-29 JP JP24456291A patent/JP3065735B2/en not_active Expired - Fee Related
-
1992
- 1992-08-12 US US07/928,455 patent/US5342347A/en not_active Expired - Fee Related
- 1992-08-25 CA CA 2076773 patent/CA2076773C/en not_active Expired - Fee Related
- 1992-08-26 ES ES92114516T patent/ES2080397T3/en not_active Expired - Lifetime
- 1992-08-26 DE DE1992606354 patent/DE69206354T2/en not_active Expired - Fee Related
- 1992-08-26 EP EP19920114516 patent/EP0529595B1/en not_active Expired - Lifetime
- 1992-08-28 KR KR1019920015580A patent/KR100201014B1/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| US5342347A (en) | 1994-08-30 |
| CA2076773A1 (en) | 1993-03-01 |
| JPH0556998A (en) | 1993-03-09 |
| DE69206354D1 (en) | 1996-01-11 |
| EP0529595B1 (en) | 1995-11-29 |
| KR100201014B1 (en) | 1999-06-15 |
| DE69206354T2 (en) | 1996-05-30 |
| KR930003892A (en) | 1993-03-22 |
| EP0529595A1 (en) | 1993-03-03 |
| JP3065735B2 (en) | 2000-07-17 |
| ES2080397T3 (en) | 1996-02-01 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |