WO2003092574A1 - Multiple-chamber medical container and bag for enclosing same - Google Patents
Multiple-chamber medical container and bag for enclosing same Download PDFInfo
- Publication number
- WO2003092574A1 WO2003092574A1 PCT/JP2003/005327 JP0305327W WO03092574A1 WO 2003092574 A1 WO2003092574 A1 WO 2003092574A1 JP 0305327 W JP0305327 W JP 0305327W WO 03092574 A1 WO03092574 A1 WO 03092574A1
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- WO
- WIPO (PCT)
- Prior art keywords
- chamber
- container
- small container
- seal portion
- small
- 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
- A61J1/2093—Containers having several compartments for products to be mixed
-
- 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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
-
- 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
- B65D81/3261—Flexible containers having several compartments
- B65D81/3266—Flexible containers having several compartments separated by a common rupturable seal, a clip or other removable fastening device
-
- 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
- B65D81/3261—Flexible containers having several compartments
- B65D81/3272—Flexible containers having several compartments formed by arranging one flexible container within another
-
- 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
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- 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
- A61J1/2024—Separating means having peelable seals
Definitions
- the present invention relates to multiple-chamber medical containers for individually enclosing therein different kinds of unstable medicaments which would undergo changes with time when mixed together and which can be mixed together in an aseptic state without producing any extraneous matter by opening a seal portion for partitioning the chambers.
- IVH intravenous hyperalimentation
- carbohydrates, amino acids and electrolytes serving as nutrients are usually given, whereas for example if glucose and amino acids are preserved as enclosed in a single container, themixture becomes brown due to the so-calledMaillard reaction. Accordingly, these different kinds of medicaments need to be contained separately. For this reason, medical containers having a plurality of chambers for enclosing such medicaments are introduced into wide use in recent years .
- Suchamedical container comprises two chambers , forexample, for respectively enclosing a parenteral solution containing amino acids and a parenteral solution containing glucose, and a seal portion partitioning these chambers separately.
- the seal portion is so adapted as to usually close a space between the two chambers and to open the space for use.
- an increased internal pressure of the chamber opens the seal portion to mix the medicaments in the two chambers together.
- a conduit is then connected to an outlet provided in the container, the medicinal mixture can be given to the patient.
- the present applicant has proposed a multiple-chamber container as disclosed in WO, AlNo.99/39679.
- the proposed container has, in addition to the conventional structure described, a small container enclosing a vitamin preparation therein and provided inside one of the chambers. The small container can be opened by being pressed f om outside .
- the seal portion is opened to mix together the medicaments in the two chambers, and the small container in the chamber is opened by being pressed from outside to mix the vitamin preparation with the mixture.
- the construction described above nevertheless involves the necessity of opening the small container in addition to the opening of the seal portion, hence the problem of a cumbersome procedure. Especially busy places of medical services, such a cumbersome procedure often burdens the worker heavily.
- An object of the present invention which has been accomplished to overcome this problem, is to provided a medical container comprising a plurality of chambers and adapted to readily and reliably open a small container therein.
- the present invention provides a multiple-chamber medical container, the container comprising a container body having the chambers for containing medicaments therein and a partitioning seal portion for separating the chambers from one another, a medicinal outlet portion attached to the container body for discharging the medicaments from the chambers therethrough, and an openable small container disposed in at least one of the chambers and having a medicament enclosed therein, the partitioning seal portion being openable so as to cause the chambers to communicate with one another for use.
- the small container can be opened by opening the partitioning seal portion.
- the small container is so adapted that it can be opened by opening the partitioning seal portion. This eliminates the need to open the small container in addition to the opening of the partitioning seal portion.
- the small container can therefore be opened with ease reliably, consequently reducing the burden on the worker at the busy place of medical services .
- the partitioning seal portion can be formed by bonding opposed inner wall surfaces of the container body separably.
- the small container being formed with a sheet material which is bonded to the opposed inner wall surfaces of the container body, the small container being openable in accordance with the separation of the inner wall surfaces caused by opening the partitioning seal portion.
- the small container can be at least partly bonded to the inner wall surfaces within the partitioning seal portion or within the chamber.
- the distance between the small container and the partitioning seal portion be 0 to 50 mm.
- the small container be heat-sealed at at least one portion of a peripheral edge thereof, the sealed portion being openable by an external force, a nonbonded portion of the small container inwardly of the sealed portion of the peripheral edge having a bondedportion bonded to the inner wall surfaces of the chamber.
- the bonded portion of the small container can be provided byapluralityof bondedparts arrangedwithat least onenonbonded part positioned therebetween.
- the above-mentioned at least one nonbonded part is provided in the vicinity of a center of the bonded portion.
- the sheet material of the small container can comprise a multilayer film and the small container can be opened by delaminating the multilayer film.
- the sheet material of the small container can comprise a multilayer film formed by laminating a plurality of resin layers having low miscibility with one another.
- the sheet material of the small container is at least partly heat-sealed, and the sealed portion is made openable by an external force.
- the small container is disposed in at least one of the chambers , wherebythemedicament can be accommodated in the chamber. Even if the medicament to be accommodated in the chamber is altered in quantity, the same container body of unalterd size is usable by using a small container of different size. Further if the medicament to be accommodated is susceptible to photo-deterioration, there is no need to change the material of the entire container body, but the container body is made usable by changing only the material of the small container. The medicinal container is therefore available at a reduced production cost .
- the medical container can then be so designed that the medicinal outlet portion is connected to the chamber having the small container disposed therein.
- the medical container described can further be provided with a discharge-control seal portion serving as an openable partition between the medicinal outlet portion and the chamber. If an attempt is made to discharge the medicament through the medicinal outlet portion in error, for example, before opening thepartitioning sealportio , the flowof themedicament from the chamber can be blocked by the discharge-control seal portion, thus preventing themedicament frombecomingdischarged before mixing. This makes the worker to realize the proper method of using the medical container, furthermaking it possible to discharge the medicaments only after mixing.
- the present invention further provides a bag for enclosing therein at least one multiple-chamber medical container and described above.
- the bag is characterized in that the bonded portion of the small container is provided approximately in parallel to the partitioning seal portion, the medical container being folded along an edge of the bonded portion on one side thereof opposite to the partitioning seal portion before being placed into the bag.
- FIG. 1 is a plane view showing a first embodiment of multiple-chamber medical container according to the invention.
- FIG. 2 includes views in section taken along the line A-A in FIG. 1.
- FIG. 3 is a plane view showing another example of multiple-chamber medical container of FIG. 1.
- FIG. 4 is a plane view showing another example of multiple-chamber medical container of FIG. 1.
- FIG.5 is a view in section and showing the medical container of FIG. 1 as folded in two.
- FIG. 6 includes fragmentary views in section and showing another example of multiple-chamber medical container of FIG. 1.
- FIG. 7 includes views showing an exemplary process for producing the multiple-chamber medical container according to the invention.
- FIG. 8 includes views showing another exemplary process for producing the multiple-chamber medical container according to the invention.
- FIG. 9 is a plane view showing a second embodiment of multiple-chamber medical container according to the invention.
- FIG. 10 includes a fragmentary plane view and a view in section which show another example of multiple-chamber medical container of FIG. 6.
- FIG. 11 is a plane view showing a third embodiment of multiple-chamber medical container according to the invention.
- FIG. 12 is a plane view showing another example of the multiple-chamber medical container according to the third embodiment of the invention.
- FIG. 13 includes views showing other examples of small containers for use in the multiple-chamber medical container of the invention.
- FIG.14 is aview showing another example of small container for use in the multiple-chamber medical container of the invention.
- FIG. 1 is a plane view of a multiple-chamber medical container according to the first embodiment of the invention, and FIG.2 includes views in section taken along the line A-A in FIG. 1.
- the medical container 1 comprises a rectangular container body 5 formed by heat-sealing two films along peripheral edge portions 3 thereof, and a medicinal outlet portion 7 joined to the container body 5 and having a rubber plug therein.
- the container body 5 has a first chamber 9 and a second chamber 11 which are arranged longitudinally thereof for enclosing medicaments therein.
- the two chambers 9, 11 are separated by a partitioning weak seal portion (partitioning seal portion) 13.
- the first chamber 9 has disposed therein a small container 15 containing a medicament therein as will be described later .
- the medicinal outlet portion 7 is connected to the second chamber 11.
- the end of the container body 5 opposite to the outlet portion 7 is provided with a suspending hole 17 for use in suspending the container 1.
- the material of the films for the container body 5 can be any of various resin materials such as polyethylene, polypropylene, polystyrene and like thermoplastic resin. Usable is not only a film of single layer but a film of multilayer structure, such as a three-layer film comprising an inner layer and an outer layer of polyethylene, polypropylene or like polyolefin and an intermediate layer of cyclic olefin copolymer.
- the partitioning weak seal portion 13 is formed by heat-sealing the two films of the container body 5 and extends in a direction approximately perpendicular to the longitudinal direction of the container body 5. The seal portion 13 is heat-sealed with such a strength as to usually separate the two chambers 9, 11 and to be opened for use by increasing the internal pressure of the chamber for use.
- the chambers 9, 11 have accommodated therein respective different medicaments a, b which need to be separated because they undergo the Maillard reaction or like change with time when mixed together or made into a solution.
- a solution containing amino acids can be placed in one of the chambers, and a solution containing a reducing sugar in the other chamber.
- electrolytes or the like can be accommodated in one of the chambers.
- a solution containing amino acids can be placed in one of the chambers, and a solution containing a reducing sugar in the other chamber.
- electrolytes or the like can be accommodated in one of the chambers.
- other powder or solid medicament can be accommodated in one of the chambers.
- the small container 15 is in the form of a bag formed by heat-sealing the peripheral edges of two multilayer films (sheet material) and has a vitamin D solution enclosed therein.
- the multilayer film is a three-layer film which is susceptible to delamination and which can be prepared by sandwiching a cyclic olefin polymer layer between polyethylene layers .
- a film which comprises an intermediate layer of resin having low miscibility with other resin layers and which is liable to delaminate such as a film prepared by sandwiching a polypropylene layer between polyethylene layers .
- the innermost layer be 5 to 50 ?m in thickness.
- the medicament to be enclosed in the small container 15 can be selected from among a wide variety of medicaments which are undesirable to directly mix with the medicaments in the chambers 9, 11, such as powder or liquid medicaments of antibiotics. anticancer drugs or cardiotonic drugs .
- the liquid medicaments usable include those of vitamins or trace elements, solutions such as physiological saline and glucose solution, and parenteral compositions.
- the small container 15 has one end heat-sealed to the inner wall surfaces of the films 5a, 5b forming the first chamber 9, and the heat-sealed portion provides abondedportion 19.
- Thebondedportion 19 ispositioned about 10 mm away from the partitioning weak sealed portion 13, extends in parallel to the portion 13 and is thermally bonded with a strength higher than that of the weak seal portion 13 and usually not permitting separation of the bonded portion 19 like the peripheral edge portion 3 of the container body 5.
- the multiple-chamber medical container and thus constructed will be used in the manner to be described next .
- the first or second chamber 9 or 11 is pressed as by manual pressing to increase the internal pressure of the chamber, whereby the partitioning weal seal portion 13 is opened to cause the first and second chambers 9, 11 to communicate with each other, mixing together the medicaments in the chambers 9, 11.
- the weak seal portion 13 is opened at this time by the separation of the films 5a, 5b of the container body 5, thereby opening the small container 15.
- the resulting forces F act on the small container 15. Since the two multilayer films 15a, 15b of the small container 15 are fixed to the films 5a, 5b of the container body 5 by the bonded portion 19, the multilayer films 15a, 15b are separated along with the films 5a, 5b of the container body 5 at this time. As a result, one of the multilayer films 15a, 15b forming the small container 15 delaminates to rupture. In this way, the vitamin D solution enclosed in the small container 15 becomes mixed with the mixture of medicaments. The rubber plug of the medicinal outlet portion 7 is then pierced with a needle having a conduit (not shown) connected thereto, whereby the resulting mixture is administered to the patient through the conduit.
- the multilayer films 15a, 15b forming the small container 15 are heat-sealed with a high strength to the inner wall surfaces of the first chamber 9 in the vicinity of the partitioning weak seal portion 13, so that the forces F for separating the films 5a, 5b of the container body 5 due to the opening of the weak seal portion 13 can be delivered to the small container 15 for the forces F to open the small container 15.
- This makes it possible to open the small container 15 with ease reliably while eliminating the need for an additional procedure for opening the small container 15 as conventionally practiced and consequently reducing the burden on the worker at the busy place of medical service.
- the small container 15 is fixedly provided at a position 10 mm away from the partitioning weak seal portion accordingly the present embodiment, the small container 15 need not always be so positioned but can be positioned as desired.
- the small container be positioned at a distance of 0 to 50 mm, more preferably 3 to 10 mm, from the weak seal portion 13 so that the forces to separate the films 5a, 5b of the container body 5 can be efficiently delivered to the small container when the weak seal portion 13 is opened.
- the small container 15 can be positioned as partly inserted into the partitioning weak seal portion 13.
- a nonbonded part 19a where the small container 15 is not bonded to the inner wall surfaces can be provided at an intermediate part of the bonded portion 19.
- this portion 19 can be relieved of the pressure through the nonbonded part 19a. This prevents the pressure from acting concentrically on the bonded portion 19.
- the bonded portion 19 may have a structure other than the one shown in FIG. 3 insofar as this portion 19 comprises a plurality of bonded parts arranged with at least one nonbonded part 19a positioned therebetween.
- the nonbonded part 19a is then provided preferably in the vicinity of the center of the bonded portion 19 on which the pressure is most likely to act .
- the bonded portion 19 is formed in the heat-sealed peripheral edge portion of the small container 15 according to the present embodiment. Since the small container 15 is then subjected to double heat sealing, the peripheral edge of the small container 15 appears to exhibit an impaired strength or appears liable to break. For this reason, the bonded portion 19 can be formed at a position inwardly of the peripheral edge of the small container 15 where the small container is not heat-sealed to bond the small container 15 to the container body 5 as shown in FIG. 4.
- the multiple-chamber medical container 1 is transported usually as folded in two and placed in a bag. Accordingly, the bonded portion 19 provided at the specified position for fixedly bonding the small container 15 by heat sealing has the following advantages.
- the bonded portion 19 is provided in parallel to the partitioning weak seal portion 13 as shown in FIG. 5. Therefore, container 1 will be so folded that the first chamber 9 is positioned up, with the bonded portion 19 serving as a fold for folding the container 1 in two and disposed at one end of the folded container 1. Even if the first chamber 9 is thenpressedandtherebygivenan increasedinternalpressure, the force resulting from this pressure and to be delivered to the weak seal portion 13 is blocked by the bonded portion 19. Furthermore, folding the container 1 in two at the bonded portion 19 serves to prevent the container body 5 from inflating in the vicinity of the bonded portion 19. Consequently, the above arrangement of the bonded portion 19 can prevent the weak seal portion 13 from opening even if the chamber having the small container 15 therein is pressed on during transport.
- the bonded portion 19 providing a fold nevertheless has the likelihood that this portion 19 will break when subjected to a force produced by the folding of the component films. Accordingly, if the container 1 is folded in two along a line L shown in FIG. 4, i.e., along the upper edge of the bonded portion 19, the advantages described above are available, with the bonded portion 19 reliably prevented from breaking. Although one container 1 is shown as placed in the bag F in FIG. 5, at least two containers 1 can be placed into the bag. Further according to the present embodiment, the small chamber 15 is formed by the multilayer films 15a, 15b and made openable utilizing delamination, whereas single-layer films (sheet material) 15a, 15b can alternativelybe used for attaching the small chamber to the container body in the following manner.
- the peripheral edge portion of the small container 15 is partly made openable by forming a weak seal portion 21 as by heat sealing, and the outer surfaces of the films 15a, 15b forming the weak seal portion 21 are heat-sealed to the respective inner wall surfaces of the first chamber 9 to form bonded portions 23.
- care must be taken so as not to impart an increased opening strength to the weak seal portion 21 by giving the heat-sealing effect for forming the bonded portions 23 to the weak seal portion 21.
- only the outer surfaces of the weak seal portion 21 are heat-sealed to the inner wall surfaces of the first chamber 9. This structure permits the weak seal portion 21 also of the small container 15 to be opened by opening the partitioning weak seal portion 13 as shown in FIG. 6(b).
- the medicament in the small container 15 can therefore be mixed with the medicaments in the chambers reliably by a facilitated procedure.
- it is more preferable to use multilayer films because the films are liable to delaminate even if the films of the small chamber 15 is strongly heat-sealed throughout the combined thickness of the films.
- the medical container described above can be fabricated by various processes, which include, for example, the following processes.
- a container body is first strongly heat-sealed at opposite side portions of peripheral edge thereof to form strong seal portions 3a, and a partitioning weak seal portion 13 interconnecting the strong seal portions 3a is formed [FIG. 7(a)].
- a small container 15 enclosing a medicament therein is placed into an upper chamber, i.e., a first chamber 9.
- the small container 15 is placed in as positioned close to the weak seal portion 13 [FIG. 7(b)].
- a bonded portion 19 is then formed inwardly of the peripheral edge of the small container 15 to bond the small container 15 to the films forming the container body 5 [FIG. 7(c)].
- the bonded portion 19 can be formed at a peripheral portion of the small container 15 , i.e., at a heat-sealed portion thereof.
- a medicament is injected into the first chamber 9 through an opening at the upper end of the container body [FIG. 7(d)], and the first chamber 9 is thereafter sealed off by heat-sealing the upper end 3b of the container body 5 [FIG. 7(e)].
- a port portion is alternatively formed in an upper end portion of the container body 5 to place in the medicament through the port portion.
- opposite-side strong seal portions 3a and a partitioning weak seal portion 13 are formed in a container body [FIG. 8(a)], and a small container 15 is placed into the first chamber 9 [FIG.8(b)] andthereafterbondedto the container body in the same manner as above.
- the upper end 3b of the container body 5 is heat-sealed except for the part thereof for inserting the port portion therethrough [FIG. 8(c)].
- the port portion 16 is inserted through the nonsealed part of the container body upper end 3b, and the port portion 16 is bonded to the upper end 3b by heat sealing [FIG. 8(d)].
- a medicament is then injected into the first chamber 9 through the port portion 16 [FIG. 8(e)], and a plug 16ais fittedinto theport portion 16 [FIG.8(f)].
- the medical container can be fabricated by placing in the medicament through the nonsealed part without attaching the port portion and thereafter heat-sealing this part.
- a medicament can be placed in and a medicinal outlet portion 7 can be attached in the same manner as shown in FIGS.
- the multiple-chamber medical container 1 is provided with an discharge-control weak seal portion (discharge-control seal portion) 25 serving as a partition between the second chamber 11 and the medicinal outlet portion 7.
- This discharge-control weak seal portion 25 is in the form of a circular arc surrounding one end of the outlet portion 7 and is formed by heat sealing with substantially the same strength as the partitioning weak seal portion 13.
- the discharge-control weak seal portion 25, resembling a circular arc, may be shaped otherwise and is not particularly limited in shape insofar as this portion serves as a partition between the second chamber 11 and the outlet portion 7.
- the partitioning weak sealportion 13 is openedfirst to therebyopen the small container 15 and mix the medicaments together.
- the discharge-control weak seal portion 25 is opened next, and the medicinal outlet portion 7 is subsequently pierced with a needle, whereupon the medicinal mixture is run off through the outlet portion 7.
- the discharge-control weak seal portion thus provided has the following advantage. Conventionally, if the outlet portion 7 is piercedwithaneedle inerrorbefore thepartitioning weak seal portion 13 is opened, there is the likelihood that the medicament within the second chamber 11 will be discharged through the outlet portion 7 before mixing, whereas when the discharge-control weak seal portion 25 is provided, the medicament in the second chamber 11 is blocked by the seal portion 25 and will not be discharged through the outlet portion 7 even if the needle pierces the outlet portion 7 before the partitioning weak seal portion 13 is opened. This directs the worker ' s attention to the proper method of using the medical container, further making it possible to discharge the medicaments only after mixing.
- FIG. 10(a) shows an example wherein the partitioning weak seal portion 13 is provided at an intermediate part thereof with a V-shaped projection 27.
- the pressure acts on the weak seal portion 13 in the directions of arrows shown. Since equal pressures act on the weak seal portion 13 perpendicular thereto at this time, the total pressure acting on the projection 27 at and around its top C is greater than the pressure in the other region of the weak seal portion 13.
- the pressure acts in such directions as to separate the films forming the container body 5 as shown in FIG. 10(b), and the weak seal portion 13 starts to separate first at the top C of the projection 27 when the internal pressure in the chamber 11 further builds up. Consequently, the separation proceeds rapidly under the action of the pressure, opening the partitioning weak seal portion 13 before the discharge-control weak seal portion 25 is opened and thereby causing the first and second chambers 9, 11 to communicate with each other to mix the medicaments.
- the small container 15 is also opened at the same time.
- the two weak seal portions 13,25 can be made different in opening strengthwhile permitting the weak seal portions 13, 25 to have the same width and the same bond strength. Accordingly, the two seal portions 13, 25 can be formed by heat sealing under the same conditions without the necessity of adjusting the heat-sealing time. This shortens the time required for fabricating the container 1 and results in a reduced production cost.
- the outlet portion 7 can be provided with a sealed portion for closing the outlet portion 7 on one side thereof closer to the second chamber 11, such that the medicament within the second chamber 11 does not reach the outlet portion 7 unless the sealed portion is subjected to an external force.
- the medical container of this embodiment has a first chamber 9 wherein the small container 15 alone is disposed, with no medicament accommodated directly therein.
- a second chamber 11 directly accommodates a liquid medicament b as in the foregoing embodiments.
- the medicament to be accommodated in the first chamber 9 is very small in quantity as compared with the size of the chamber, the medicament readily diffuses, so that it is difficult to mix the medicament with the medicament b within the second chamber 11 unless the medicament b is made present over the substantially entire area of the first chamber 9.
- the small container 15 is made smaller in size in accordance with the quantity of the medicament a, the medicament can be held present concentrically at one location without diffusing. Accordingly, the medicament a in the small container 15 and the medicament b in the second chamber 11 can be mixed together reliably when the partitioning weak seal portion 13 and the small container 15 are opened.
- the present embodiment has another advantage .
- the small container 15 is formed by films of a material to which the medicament is less likely to be adsorbed or which is less susceptible to photo-deterioration, and is accommodated in the first chamber 9.
- the small container 15 only can then be of a material suitable for the medicament to be accommodated. This obviates the need to change the material of the entire container body 5 in conformitywith the medicament , consequently entailing a cost reduction in the case where such a medicament as described above is to be used.
- the equipment for producing the container body 5 need not be provided with sterilizing equipment for practicing the two sterilizing methods because the small container can be fabricated separately from the container body 5.
- the medicament a for the small container 9 may be sterilized by the equipment for producing the small container 15, so that the equipment for producing the container body 5 can be provided only with the sterilizing equipment for the medicament for the second chamber 11. The production equipment can therefore be simplified.
- the small container 15 is accommodated in the first chamber 9, the small container 15 can be accommodated alternatively in the second chamber 11 as seen in FIG. 12. This arrangement has the following advantage.
- amedicament and the small container 15 can be accommodated in the first chamber 9, with the second chamber 11 left empty.
- the small container 15 can then be opened easily, while this embodiment has the above advantage of preventing the medicaments from being discharged before mixing.
- FIG. 13(a) shows a plurality of incisions 18 formed in the lower edge of the small container 15.
- the forces for separating the sheets of the small container 15 can be transmitted to the peripheral edge of the small container 15 through the incisions 18, rendering the peripheral edge liable to break along the line S shown in the drawing.
- the small container 15 can be opened with greater ease.
- the means described above can be used in a suitable combination tomake the small container 15 with further increased ease. More specifically, two or all of the means shown in FIGS. 13(a) to 13(c) can be used in combination.
- the partitioning weak seal portion 13 and the discharge-controlweaksealportion 25 areformedbyheat-sealing films according to the foregoing embodiments, this method is not limitative; the films can be otherwise treated in various modes inso ar as they are made openable by applying an external force or forces.
- the opposed film surfaces of the container body 5 can be provided with a ridge and a furrow, respectively, so as to fit the respective mating the ridge and furrow together separably.
- a partitioning film can be provided which is locally made smaller in thickness so as to rupture at the thin portion when subjected to a pressure and to cause the two chambers to communicate with each other.
- the small container 15 can be opened by separating the films of the container body 5 and thereby causing the two chambers 9, 11 to communicate with each other.
- the bonded portion 19 for bonding the small container 15 to the films of the container body 5 need not always be inparallel to thepartitioningweak sealportion 13 as previously described, or is not particularly limited in shape insofar as the forces F resulting from the separation of the films of the container body 5 can be delivered to the small container 15.
- the bonded portion 19, which is formed by heat sealing, can be formed otherwise or is not particularly limited in structure insofar as the small container can be reliably bonded to the container body 5 by the bonded portion.
- the small container 15 which is formed by multilayer films or which has a weak seal portion locally in the peripheral edge thereof as described above, can be otherwise constructed insofar as the container 15 is openable by separating the films of the container body 5.
- the small container 15 can be fabricated in its entirety from thin films which can be ruptured easily.
- the small container 15 is not limited to one in number; at least two small containers can be provided.
- the chamber wherein the small container is disposed is not limited only to the first chamber 9 but can also be the second chamber 11,
- the small container 15 itself can be divided into a plurality of compartments by a partition or partitions.
- the chambers are not limited to two in number as described above but can be at least three.
- the chambers may be separated by partitioning weak seal portions like the one already described.
- the small container may be disposed in at least one of these chambers in the manner described above.
- the partitioning seal portion for separating the chambers which is a weak seal portion formed by heat-sealing the film surfaces according to the embodiments described, can alternatively be a strong seal portion which can be opened by pulling the opposed films of the container body in directions to separate these films. Even the strong seal portion ensures the same advantage as already described, i.e., the advantage that the small container can be opened by opening the strong seal portion.
- a multiple-chamber medical container comprising: a container body having the chambers for containing medicaments therein and a partitioning seal portion for separating the chambers from one another, a medicinal outlet portion attached to the container body for discharging the medicaments from the chambers therethrough, and an openable small container disposed in at least one of the chambers and having a medicament enclosed therein; the partitioning seal portion being openable so as to cause the chambers to communicate with one another for use, the small container capable of being opened by opening the partitioning seal portion.
- Amultiple-chamber medical container wherein the partitioning seal portion is formed by bonding opposed inner wall surfaces of the container body separably, the small container is formed with a sheet material which is bonded to the opposed inner wall surfaces of the container body, and the small container opens in accordance with the separation of the inner wall surfaces caused by opening the partitioning seal portion.
Abstract
Description
Claims
Priority Applications (9)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AT03727991T ATE451903T1 (en) | 2002-04-30 | 2003-04-25 | MULTI-CHAMBER MEDICAL CONTAINER AND BAG FOR COVERING IT |
JP2004500759A JP4096200B2 (en) | 2002-04-30 | 2003-04-25 | Medical multi-chamber container and storage bag for storing the same |
DK03727991.6T DK1499274T3 (en) | 2002-04-30 | 2003-04-25 | Multi-chamber medicine container and bag to enclose the same |
KR1020047017517A KR100654894B1 (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
DE60330552T DE60330552D1 (en) | 2002-04-30 | 2003-04-25 | MEDICAL MULTI-CHAMBER CONTAINER AND BAG TO HIS WRAPPING |
EP03727991A EP1499274B1 (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
AU2003234087A AU2003234087B2 (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
US10/509,673 US8343128B2 (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
CA2482520A CA2482520C (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2002-128336 | 2002-04-30 | ||
JP2002128336 | 2002-04-30 | ||
JP2002229704 | 2002-08-07 | ||
JP2002-229704 | 2002-08-07 | ||
JP2003-38927 | 2003-02-17 | ||
JP2003038927 | 2003-02-17 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003092574A1 true WO2003092574A1 (en) | 2003-11-13 |
Family
ID=29407509
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/JP2003/005327 WO2003092574A1 (en) | 2002-04-30 | 2003-04-25 | Multiple-chamber medical container and bag for enclosing same |
Country Status (17)
Country | Link |
---|---|
US (1) | US8343128B2 (en) |
EP (1) | EP1499274B1 (en) |
JP (1) | JP4096200B2 (en) |
KR (1) | KR100654894B1 (en) |
CN (1) | CN100339065C (en) |
AT (1) | ATE451903T1 (en) |
AU (1) | AU2003234087B2 (en) |
CA (1) | CA2482520C (en) |
DE (1) | DE60330552D1 (en) |
DK (1) | DK1499274T3 (en) |
EG (1) | EG24884A (en) |
ES (1) | ES2334657T3 (en) |
MY (1) | MY140544A (en) |
PT (1) | PT1499274E (en) |
SG (1) | SG144745A1 (en) |
TW (1) | TWI226235B (en) |
WO (1) | WO2003092574A1 (en) |
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JP2006187429A (en) * | 2005-01-05 | 2006-07-20 | Otsuka Pharmaceut Factory Inc | Manufacturing method of medical double-packaged pharmaceutical and medical double packaged pharmaceutical |
JP2006247378A (en) * | 2005-02-08 | 2006-09-21 | Otsuka Pharmaceut Factory Inc | Medical dual chamber container |
JP2007014632A (en) * | 2005-07-08 | 2007-01-25 | Otsuka Pharmaceut Factory Inc | Multi-chamber container |
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US20130126370A1 (en) * | 2010-06-17 | 2013-05-23 | David DiLiberto | Multi-compartment container with frangible seal and external means for applying opening force between compartments |
US8465819B2 (en) | 2005-04-28 | 2013-06-18 | Otsuka Pharmaceutical Factory, Inc. | Drug solution container package and method for manufacturing the same |
US9004761B2 (en) | 2006-05-01 | 2015-04-14 | Baxter International Inc. | Multiple chamber container with mistake proof administration system |
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- 2003-04-25 DK DK03727991.6T patent/DK1499274T3/en active
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WO2005123001A1 (en) * | 2004-06-18 | 2005-12-29 | Gambro Lundia Ab | A medical fluid bag arrangement and a method of providing, arranging and treating medical fluids |
JP2006043129A (en) * | 2004-08-04 | 2006-02-16 | Otsuka Pharmaceut Factory Inc | Medical double-chamber container, manufacturing method thereof, and method for housing thereof |
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US9901513B2 (en) | 2006-10-27 | 2018-02-27 | Otsuka Pharmaceutical Factory, Inc. | Drug solution having reduced dissolved oxygen content, method of producing the same and drug solution containing unit having reduced dissolved oxygen content |
US20130126370A1 (en) * | 2010-06-17 | 2013-05-23 | David DiLiberto | Multi-compartment container with frangible seal and external means for applying opening force between compartments |
US10279978B2 (en) | 2010-06-17 | 2019-05-07 | David DiLiberto | Multi-compartment container with frangible seal and vapor permeable region |
EP3391890B1 (en) | 2010-06-29 | 2021-08-25 | Merck Sharp & Dohme Corp. | Posaconazole intravenous solution formulations stabilized by substituted beta-cyclodextrin |
Also Published As
Publication number | Publication date |
---|---|
CA2482520A1 (en) | 2003-11-13 |
EP1499274A1 (en) | 2005-01-26 |
US8343128B2 (en) | 2013-01-01 |
ES2334657T3 (en) | 2010-03-15 |
CN100339065C (en) | 2007-09-26 |
TWI226235B (en) | 2005-01-11 |
JP2005523772A (en) | 2005-08-11 |
DK1499274T3 (en) | 2010-02-08 |
AU2003234087B2 (en) | 2008-04-17 |
CA2482520C (en) | 2011-01-04 |
US20050177128A1 (en) | 2005-08-11 |
SG144745A1 (en) | 2008-08-28 |
DE60330552D1 (en) | 2010-01-28 |
ATE451903T1 (en) | 2010-01-15 |
JP4096200B2 (en) | 2008-06-04 |
TW200307531A (en) | 2003-12-16 |
KR100654894B1 (en) | 2006-12-08 |
AU2003234087A1 (en) | 2003-11-17 |
PT1499274E (en) | 2010-03-01 |
EG24884A (en) | 2010-12-05 |
CN1649557A (en) | 2005-08-03 |
KR20040106430A (en) | 2004-12-17 |
EP1499274B1 (en) | 2009-12-16 |
MY140544A (en) | 2009-12-31 |
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