Drug container and dual container system for fluid therapy employing the same

Abstract: A drug container (V) is sealed by an annular packing (2) arranged on the open end of the container body (1), a spherical closing member (3) held on the annular packing (2), and a cap-like holder (4) fitted on the mouth portion of the container body. In use, the drug container (V) is screwed in a solvent container assembly (S) having a partition wall (30) with a pushing rod (31). The spherical closing member (3) is pushed out from the packing (2) by the pushing rod (31) and then the partition wall (30) is broken out by the holder (4) of the drug container (V) to communicate the container body (1) with the solvent container (21).

Description: 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 diluent just before use to prepare a parenteral fluid for intravenous drip infusion. Such drugs are generally supplied in the form of powder or a freeze-dried preparation and packaged in a drug container or a vial because of their poor conservation stability in the liquid state or of any other reasons. It is therefore required to mix the drug in the container or vial with a solvent or diluent contained in another container. In this case, the drug container or vial is usually connected to the solvent container by a 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 very 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 and being supported in the capsule, and a means for coupling the capsule to the interior of the flexible container. In this system, the drug vial is communicated with the flexible container through a communicating means arranged in the coupling means, thus making it possible to aseptically mix the drug with the solvent. 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 its one end and being connected to a mouth portion of the flexible container at the connecting portion, a drug container held in the capsule, and a communicating means arranged in the capsule to form a passage communicating the flexible container with the drug container. In this system, the communicating means is firstly pierced into the drug vial and then pierced into the flexible container to communicate the flexible container with the drug container. Since the flexible container is communicated with the drug container in the closed system, it is possible to aseptically mix the drug with the solvent. JP-A- H3-37067 discloses a container for infusion fluid comprising a bag member of a thermoplastic resin, a drug vial held in the bag member at the inverted state, a liquid container containing a diluent, a flexible cylindrical member connected to the bag member at one end and to the liquid container at the other end, a communicating means arranged between the drug container and the liquid container and housed in the cylindrical member, and a means for supporting the drug container and the liquid container, said supporting means being positioned between the drug vial and the liquid container so as to prevent the two containers from close to each other until 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 discloses a drug delivery system comprising a first flexible container having an opening at one end, and a second container having a removable stopper and capable of being fixed to the bottom wall of the first container therethrough, and a stopper removing means having a portion engaging with the stopper. JP-B- H2-26506 discloses an improved drug delivery system having a structure similar to that of JP-A- S59-209535. Also, JP-A-S62-137056 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 an unpleasant feeling to a patient as 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 which is simple in structure and enables to aseptically mix 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 which is able to aseptically perform all operations of 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, a means for sealing an open end of the container body, and a covering member for covering at least said sealing means and a mouth portion of said container body, known from e.g. US-A-4 583 971, characterized in that said container body is provided with a connecting means and a sealing member on the outside wall of the mouth portion thereof and with an annular seat on the inside wall of the mouth portion thereof, and that said sealing means comprises an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of said 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. In a preferred embodiment, the covering member comprises a cap-like member partially enlarged in diameter on the side of the open end thereof to form an enlarged skirt portion. This cap-like member is put 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 the first, drug container and second, solvent containers separated from one another, said first container containing a dose of a drug and comprising: a bottle-shaped container body provided with a connecting means and a sealing member on the outside wall of a mouth portion of the container body and with an annular seat on the inside wall of the mouth portion thereof; a means for sealing an open end of the container body; and a covering member for covering at least said sealing means; said sealing means comprising an annular packing of an elastomeric material having an inside diameter smaller than that of the seat of said 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, said 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 said first container, said cylindrical connecting member being connected at one end thereof to the other mouth portion of said solvent container. In a preferred embodiment, the connecting member has a means for engagement with the first container on an inside wall of the second container, a partition wall integrally connected thereto near the one end thereof where the solvent container is connected thereto, and a pushing rod extending coaxially from the central portion of the partition wall toward the opposite end of the connecting member. A hollow portion defined by the inside wall and 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 pushing 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 pushing 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. BRIEF DESCRIPTION OF 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 a drug container of Fig. 1 and a solvent container assembly of Fig. 2, illustrating a state of use. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to Fig. 1, there is shown a drug container V according to the present invention. The drug container V 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 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 so as 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 an open end thereof to form a narrow mouth portion 8. Preferably, the container body 1 is made of a transparent material such as, for example, glass or synthetic resins including polypropylene resins and polyester. The mouth portion 8 of the container body 1 is provided with a connecting means (generally a male screw) 6 and a sealing member (generally O-ring) 7 to fluidtightly and firmly connect the container body 1 with a solvent container assembly S explained later. Around the mouth portion 8 there may be provided a circumferential groove for holding the sealing meter 7 such as an O-ring for example. In the inside wall of the mouth portion 8 of the container body 1 and close to the open end, there is provided an annular packing 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. However, the packing seat 9 may take any shape, provided that it can hold the packing 2 in place and prevent it from falling off therefrom even when an external force is applied to the packing 2 in the direction perpendicular to the packing seat 9. The container body 1 is provided with an annular groove 15 adjacent to the open end of the mouth portion 8 thereof to provide a 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 which 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 than the inside diameter of the packing 2. The spherical closing member 3 is generally made of glass or a synthetic resin. However, the spherical closing member may be made of any other material, provided that it has a good chemical resistance and provides a smooth surface. This spherical closing 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 generally made of a flexible resin. Typical flexible resins as a material for the holder includes, without being limited to, polypropylene, polyethylene, polycarbonate, polyesters, polyvinyl chlorides and the like. At the central part of the top wall of the holder 4, there is provided a bore having a diameter smaller than that of the spherical closing member 3 to allow a pushing rod of the solvent container assembly to pass therethrough when connecting the drug container to the solvent container assembly. The holder 4 is provided at the lower end with an inwardly extending rib 11 adapted to be engaged with the flange 10 of the container body 1. The holder 4 is snapped on the mouth portion 8 of the container body 1 to hold the spherical closing member 3 in place as well as to press it to the packing 2. The covering member 5 is in the form of a cap or a cylindrical member closed at one end but open at the other end. A skirt portion (side wall) of the covering member 5 is partially enlarged in diameter on the side of the open end to form an enlarged skirt portion 13, at which the covering member 5 is fixed to the container 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 around the circumference of the enlarged skirt portion 13. Immediately adjacent the enlarged skirt portion 13, the covering member 5 is provided with a brittle or frangible portion 12 to allow the covering member 5 to be twisted off easily by turning it, while leaving the enlarged skirt portion 13 on the container body 1. The projections 14 are provided to prevent the drug container V from looseness of the screw connection with the solvent container assembly S. The drug container V may be used in combination with a solvent container assembly S as shown in Fig. 2. Referring now to Fig. 2, there is shown a solvent container assembly S which 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 either end. The mouth portion 29 provided at the bottom of the solvent container serves as an outlet for a 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 fitted thereon. The connecting member 22 is a cylindrical hollow body and is enlarged in diameter on the upper side thereof 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 provided a female screw 24 adapted to be engaged with the male screw 6 of the drug container V. The connecting member 22 is provided at a lower end thereof with 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 pushing rod 31 extending coaxially with the connecting member 22 in the direction toward the upper open end 36 of the connecting member 22. Also, the partition wall 30 has an annular brittle or frangible portion 32 formed coaxially with the pushing 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 in its both sides with several grooves (not shown) radially extending from the base of the pushing rod 31 towards the brittle portion 32 to form 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 pushing rod 31, it is sufficient to provide several grooves or cut in the annular rib 33 instead of the grooves to be 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 be engaged with the projections 14 of the enlarged skirt portion 13 remained on the container body 1. The upper open end 36 of the connecting member 22 is sealed by a suitable sealing means such as, for example, a laminated film 23 of aluminum foil with polyester as the external layers. In general, the above drug container V and the solvent container assembly S are separately packaged in a suitable plastic sheet to keep them in sterile conditions until just before use. The above 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 retaining the enlarged skirt portion 13 of the covering member 5 on the drug container V. On the other hand, the laminated film 23 of the solvent container assembly S is peeled off from the connecting member 22. Then, the solvent container assembly S is connected to the drug container V by screwing the connecting member 22 on 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 pushing rod 31 of the connecting 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 pressed toward 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 communicates with the solvent container 21 through a 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 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 container body 1 to flow into the solvent container 21. The resultant solution may be used for intravenous drip infusion by connecting the mouth portion 29 of the solvent container 21 to a solution infusion set. As will be understood from the above, according to the present invention, it is possible to provide a drug container which is simple in construction, easy to handle, and low in manufacture, and enables to achieve aseptic operations. Also, the present invention makes it possible to provide a drug transfusion system which makes it possible to arbitrarily determine the combination of the drug container and the solvent container as occasion demands. In addition, the use of the drug container of the present invention set a patient at ease as 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 will be 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.

Claims: A drug container (V) comprising a bottle-shaped container body (1), a means (2, 3, 4, 9) for sealing an open end of the container body (1), and a covering member (5) for covering at least said sealing means (2, 3, 4, 9) and a mouth portion (8) of said container body (1), characterized in that said container body (1) is provided with a connecting means and a sealing member (7) on the outside wall of the mouth portion (8) thereof and with an annular seat (9) on the inside wall of the mouth portion (8) thereof, and that said sealing means (2, 3, 4, 9) comprises an annular packing (2) of an elastomeric material having an inside diameter smaller than that of the seat (9) of said container body (1) and being held on the seat of said container body (1), a spherical closing member (3) having a diameter larger than the inside diameter of the packing (2) but smaller than the inside diameter of the seat and being held on the packing (2) to close the bore of said packing (2), and a cap-like holder (4) fitted on the mouth portion (8) of the container body (1) to hold the spherical closing member (3) in place. The drug container according to claim 1 wherein said covering member (5) is a cap. The drug container according to claim 1 wherein said covering member (5) is a synthetic resin sheet covering whole of the container. A dual container system for fluid therapy comprising the first, drug container (1) and second, solvent container (21) separated from one another, said first container containing a dose of a drug and comprising a bottle-shaped container body (1) provided with a connecting means and a sealing member (7) on the outside wall of a mouth portion of the container body (1) and with an annular seat (9) on the inside wall of the mouth portion thereof, a means (2, 3, 4, 9) for sealing an open end of the container body, and a covering member (5) for covering at least said sealing means (2, 3, 4, 9), said sealing means (2, 3, 4, 9) comprising an annular packing (2) of an elastomeric material having an inside diameter smaller than that of the seat of said container body (1) and being held on the seat (9) of said container body (1), a spherical closing member (3) having a diameter larger than the inside diameter of the packing (2) but smaller than the inside diameter of the seat (9) and being held on the packing (2) to close the bore of said packing (2), and a cap-like holder (4) fitted on the mouth portion (8) of the container body (1) to hold the spherical closing member (3) in place; said second container containing a dose of a solvent or diluent and comprising a solvent container (21) having a mouth portion (25, 29) at either end and being closed and sealed at one mouth portion (29) thereof by a rubber stopper (28), and a cylindrical connecting member (22) for connecting the solvent container (21) to said first container (1), said cylindrical connecting member (22) being connected at one end thereof to the other mouth portion (25) of said solvent container (21). The dual container system for fluid therapy according to claim 4 wherein said connecting member (22) has a means (24) for engagement with the first container (1) on an inside wall of the second container, a partition wall (30) integrally connected thereto near the one end thereof where the solvent container (21) is connected thereto, and a pushing rod (31) extending co-axially from the central portion of the partition wall (30) toward the opposite end of the connecting member (22), said partition wall (30) having an annular brittle portion (32) formed coaxially round the pushing rod (31), and several grooves formed in both sides of the partition to provide passages extending radially from the base of the pushing rod (31) towards the brittle portion (32). The dual container system for fluid therapy according to claim 5 wherein said engagement means (24) comprises a female screw provided on the inside wall of the connecting member (22) and adapted to be engaged with a male screw (6) provided on the mouth portion (8) of said drug container (V).

Inventors: FUTAGAWA HITOSHI, IKEDA KOJI, KIKUCHI TOSHIHIRO, FUTAGAWA, HITOSHI, IKEDA, KOJI, KIKUCHI, TOSHIHIRO
Applicants: NISSHO KK, NISSHO CORPORATION
Application year: 1992
Main classification: A61J1
IPC codes: B65D81, A61J3, A61J1, B65D83, B65D41