JP2009018038A - Multi-chambered container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a multi-liquid mixing type multi-chambered container for surely mixing medicaments when infusion is performed. <P>SOLUTION: A closing plug 30 is provided on an extension part to a medicament bag in a discharge port 12 and the discharge port 12 is normally in a closed state by the closing plug 30. A thin connecting plate 32 is integrally extended from the closing plug 30, and connection parts 36-1 and 36-2 separated by a slit 34 are strongly welded to the opposite inner layer of the medicament bag 10. The connection parts 36-1 and 36-2 are expanded and displaced by the expansion and displacement of a medical fluid bag when the partition of the medicament bag is opened, the closing plug 30 is moved along the discharge port 12 and detached from the discharge port, and thus the discharge port 12 is opened. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a multi-component mixed-type multi-chamber container used for infusion, and is capable of reliably mixing medicines at the time of infusion.

In a multi-chamber container for infusion, the inside of the drug solution bag is separated by a partition wall (weak seal part) formed by welding the opposite surface of a drug bag made of a soft film made of polyethylene or the like so that it can be peeled off at a relatively low temperature. Some are separated into a plurality of compartments each containing different chemicals. A discharge port as a plastic molded product is provided on the outer periphery of the medicine bag, the discharge port is formed in a cylindrical shape, and the internal cavity opens to one compartment on one end side, but the other end has a rubber A stopper is provided. Prior to administration of the drug solution to the patient, the weak seal is peeled open by pressurizing the drug bag from the outside, and the drug bag has an internal cavity so that the two types of drug solutions are mixed and the infusion set is punctured A rubber stopper is punctured with a needle, and a drug solution can be administered from a drug bag. Therefore, in this type of medical mixed-type multi-chamber container, it is essential to mix the two liquids by peeling and opening the weak seal portion prior to the administration of the chemical solution, while the weak seal portion is not opened. When the rubber stopper is punctured at the discharge port, there is a possibility of an erroneous operation in which only the drug solution in the compartment on the discharge port side is administered. As a conventional technique for dealing with this problem, there has been proposed a technique in which a discharge port is normally closed, but a movable member and a stopper that are opened and moved according to the internal pressure of the chemical solution bag when the partition wall is opened are provided (Patent Literature). 1 and 2).
JP 2003-305107 A JP-A-2005-28040

  In the techniques of Patent Documents 1 and 2, the discharge port is opened by moving the movable member and the plug body by applying the chemical pressure generated in the chemical bag to the movable member and the plug body when the partition wall is broken and opened. . That is, the force of the pressure receiving area × the pressure in the chemical solution bag at the time of opening is applied to the movable member and the plug, and the movable member and the plug are moved by this force. However, the movable member and the plug are provided in the discharge port, and the pressure receiving area is limited to the inner diameter of the maximum discharge port, and the pressure receiving area is not so large. For this reason, the force applied to the movable member and the plug body to move the opening is not so great, the desired movement cannot be obtained, the opening of the partition wall and the opening of the discharge port cannot be linked, and the discharge is performed despite the opening of the partition wall. It was happening that the port remained closed.

  The present invention has been made in view of the above problems, and in a multi-chamber container provided with a closing member that closes the discharge port when the partition wall is not opened, the closing member is securely detached from the discharge port when the closed partition wall is opened. The purpose is to open the discharge port.

  The multi-chamber container of the present invention includes a chemical solution bag formed of a soft film, a partition wall that separates the inside of the drug bag into a plurality of compartments by welding the opposing surfaces of the chemical solution bag so as to be capable of being pressure-released, and a chemical solution. The discharge port, which is fixed to the bag, has one end extending into the drug solution bag, the other end located outside the drug solution bag having a stopper for puncturing, and the discharge port extending into the drug bag. A closing member, which is provided at one end so as to be able to move densely or with a slight gap, and which is normally inserted at the one end of the discharge port, and in conjunction with the expansion of the chemical bag when the partition is opened, is purely mechanically linked to the above-mentioned In order to move the closing member away from the discharge port, the closing member is composed of a thin plate material, a link, a lever, a string-like member, and the like, which are connected to the inner surface of the soft film constituting the chemical solution bag by welding.

  In the present invention, the closing member movably provided at the discharge port normally closes the discharge port, and the closing member is connected to the drug bag by a connector so that the swell displacement at the opening of the drug bag is purely mechanical. In conjunction with this, the closing member is moved away from the discharge port.

  According to the present invention, since the opening / closing member is moved so as to be detached from the discharge port mechanically in conjunction with the expansion of the chemical bag when the partition wall is opened, the discharge port can be reliably opened when the partition wall is opened. The intended and intended infusion operation can always be performed.

  1 to 4, the multi-chamber container includes a flat drug bag 10 for storing a chemical solution and a cylindrical discharge port 12. The drug bag 10 is made of a synthetic resin soft film (a soft film or a flexible film of the present invention) having a multilayer structure such as a polyethylene film having a thickness of 200 microns. A pair of synthetic resin soft films constituting the drug bag 10 are stacked with the cylindrical discharge port 12 interposed therebetween, and when the entire outer peripheral portion is made of polyethylene, it is welded at a high temperature of 130 ° C., and the portion of the cylindrical discharge port 12 is also included. A strong seal portion 14 is formed along the entire circumference. Welding at parts other than the cylindrical discharge port 12 is between polyethylene films, and welding at the part of the cylindrical discharge port 12 is between the cylindrical discharge port 12 and the polyethylene film, and cannot be welded at the same time. Welding (strong sealing) is carried out, and the strong sealing portion at the cylindrical discharge port 12 is indicated by 14-1 to distinguish it from that at the remaining portion. The welding at the strong seal portions 14 and 14-1 is a temperature at which the pressure does not peel at the pressure generated in the drug bag when the drug bag 10 is pressurized to open the drug bag 10 (as described above in the case of polyethylene). Thus, regardless of the influence of external physical force, the drug solution can be held in the drug bag 10 without leaking. The strong seal portion 14 is provided with a round hole 15 for suspending the drug bag on the infusion table.

  The cylindrical discharge port 12 is configured as a thick (rigid) plastic molded product capable of maintaining its cylindrical shape. The cylindrical discharge port 12 protrudes from the drug bag 10 at the lower end of FIG. 1, and a rubber plug 20 is inserted into the lower end of the cylindrical discharge port 12 protruding from the lower end of the drug bag 10 by the puncture needle of the infusion set at the time of infusion. (Plug) is attached.

  The two synthetic resin film layers constituting the drug bag 10 are welded so as to be capable of being pressure peeled at the full width at an intermediate portion in the longitudinal direction (vertical direction in FIG. 1) of the drug bag 10, and the weak seal portion 24 (of the present invention). Partition). The inner cavity of the medicine bag 10 is separated into the first and second compartments 26 and 28 in the upper and lower parts of FIG. 1 by the weak seal portion 24, and the first and second compartments 26 and 28 are separated into the first and second compartments, respectively. Can be stored in a separated state. Welding of the upper and lower synthetic resin film layers constituting the drug bag 10 in the weak seal portion 24 can be performed by pressure peeling. The pressure peelable means that when the drug bag 10 is pressed with an appropriate force with a palm or the like for opening the drug bag 10, the weak seal portion 24 is caused by swelling (expanding deformation) due to liquid pressure generated in the drug bag 10. Means that the upper and lower film layers are peeled off, and in the case of the polyethylene resin in the embodiment of the present invention, the welding at the weak seal portion 24 is 120 ° C. (the welding temperature such as 130 ° C. described above for obtaining the strong seal portion 14). At a much lower welding temperature). FIG. 4 shows an expanded state of the chemical solution bag in the vicinity of the discharge port 12 due to the opening of the weak seal portion 24.

  In FIG. 2, the discharge port 12 has a cylindrical shape, and a separate cap 12-1 is integrated by welding at the outer end of the expanded shape, and the rubber plug 20 is attached to the cap 12-1. The inner end portion of the discharge port 12 has a tapered portion 12-2, a strong seal portion 14-1 is positioned on the outer periphery thereof, and extends to the inside of the chemical solution bag. A disc-shaped closing plug 30 (opening / closing member of the present invention) is disposed on the inner periphery of the tapered portion 12-2 of the discharge port 12 so as to be slidable in the longitudinal direction (axial direction) of the discharge port. The stopper plug 30 is formed into a disk shape from a suitable plastic or rubber material, and is integrally formed with a thin-walled connecting plate 32 (cantilevered from the discharge port 12 in a direction away from the discharge port 12, that is, toward the internal cavity of the drug solution bag. Forming the connector of the present invention). The thin connecting plate 32 is provided with a slit 34 extending in the longitudinal direction from a little before the end plug 30 to the end surface, and the thin connecting plate 32 is divided into the first connecting portion 36-1 and the second connecting portion 36-2 by the slit 34. Divided. The first connecting portion 36-1 and the second connecting portion 36-2 have the side end portions 36-1 ′ and 36-2 ′ somewhat expanded from the stopper plug 30, and the expanded end portions 36-1 ′, 36-2 ′ is firmly welded to the opposing inner surfaces of the upper and lower layers of the drug bag 10. Fig. 3 shows the welded portions of the expanded end portions 36-1 'and 36-2' with the chemical solution bag facing layer by hatched regions 38-1 and 38-2. The welds 38-1 and 38-2 are laser welded. Etc. can be implemented. The welding temperature at the time of laser welding is approximately the same as the welding temperature of the strong seal portion 14 on the outer periphery of the chemical solution bag 10, and therefore, the fluid pressure applied to the chemical solution in the chemical solution bag when the weak seal portion 24 constituting the partition wall is opened. Then, there is no peeling, and the welding between the expanded end portions 36-1 'and 36-2' and the upper and lower layers of the chemical solution bag is maintained. The thickness of the thin connection plate 32 is such that the first connection portion 36-1 and the second connection portion 36-2 are displaced following the expansion deformation of the chemical bag 10 when the weak seal portion 24 is opened. It is set appropriately so as to provide the billiness but not substantially cause the extension / breakage.

  The weak seal portion 24 is opened by placing the drug bag 10 flat on a desk or the like and pressurizing the drug bag 10 with the palm of the hand. That is, both layers of the drug bag 10 are separated at the weak seal portion 24 by the pressure of the chemical solution applied by pressurization (the state where the weak seal portion 24 is separated is shown in FIG. 4), and the compartments 26 and 28 are integrated, The chemicals separated and accommodated in the compartments 26 and 28 are mixed. And the pressure of the chemical | medical solution raised by opening of the weak seal part 24 expands the chemical | medical solution bag 10 like FIG. 4 in the connection site | part with the discharge port 12, and the thin connection board 32 is the 1st and 2nd connection part 36. -1 and 36-2 end portions 36-1 'and 36-2' are welded to the opposite inner layer of the drug bag 10 so as not to be peeled off, so that the first and second connecting portions 36-1 and 36-2 are also As a result, the stopper plug 30 is disengaged from the opening end surface of the discharge port 12 by moving to the inside of the drug bag 10 along the axis of the discharge port 12. The discharge port 12 is communicated with the inside of the drug solution bag 10 through the opening end of the discharge port 12, the mixed drug solution is allowed to flow into the discharge port 12, and the puncture needle (not shown) of the infusion set is inserted into the rubber stopper at the lower end of the discharge port. Infusion can be started by puncturing.

  In FIG. 3, in the first and second connecting portions 36-1 and 36-2 of the thin connecting plate 32, the thin portion 40- extends so as to extend in the width direction near the roots of the expanded end portions 36-1 'and 36-2'. 1, 40-2 are provided so as to further reduce the thickness of the connecting plate 32. By providing the thin-walled portions 40-1 and 40-2, the closure plug 30 floats above the welded portion after detachment from the discharge port due to easy bending at this portion, so that the discharge port is closed again by the closure plug 30. Is avoided.

  In this embodiment, instead of the slit 34, a thin portion may be formed so that the thin portion may be ruptured by bulging deformation of the chemical solution bag at the time of opening.

  5 and 6 show the second embodiment. In this embodiment, the connection plug 30 that closes the discharge port 12 is interlocked with the swelling deformation of the drug solution bag 10 when the weak seal portion 24 (partition wall) is opened. The tool is constituted by a built-in bag 42. The built-in bag 42 is composed of upper and lower synthetic resin films 44-1, 44-2. The upper and lower films 44-1, 44-2 are welded to the outer peripheral portion 46 so as to be peeled off, and the upper and lower films 44- A small compartment 48 (third chamber) is formed between 1 and 44-2, and a small amount of medicine to be added to the infusion medicine contained in compartments 26 and 28 is stored in the compartment 48. Has been. The welding temperature at the outer peripheral portion 46 is approximately the same as that of the weak seal portion 24 of the chemical solution bag 10, and is peeled off when the chemical solution bag is opened. The synthetic resin films 44-1 and 44-2 constituting the built-in bag 42 are integrated with the stopper plug 30 at one end on the discharge port 12 side, and the other end (extended portion from the peelable weld 46) 44. -1 'and 44-2' are firmly welded to the inner surface of the film facing the chemical solution bag 10, and this strongly welded portion is indicated by 50 in FIG. At this time, the welding temperature of the strong welding part 50 is approximately the same as the welding temperature of the strong seal part 14 on the outer periphery of the chemical liquid bag 10, and the welding state can be maintained without being peeled even when the chemical liquid bag is opened.

  FIG. 6 (a) shows a state in which the medical solution bag is not opened. The built-in bag 42 is in a closed state, and a small amount of medicine is stored in the small compartment 48. On the other hand, the closure plug 30 substantially closes the discharge port 12.

  FIG. 6 (b) shows when the partition wall is opened. The chemical solution in the chemical solution bag 10 is pressurized from the outside, and the weak seal portion (compartment) 24 is opened. The swelling of the chemical solution bag 10 due to the opening of the weak seal portion 24 is caused by the end portions 44-1 'and 44-2' of the synthetic resin films 44-1 and 44-2 constituting the internal bag 42 facing the inner layer of the chemical solution bag 10. Since the peelable welded portion 46 on the outer periphery of the built-in bag 42 is peeled off and the synthetic resin films 44-1 and 44-2 are separated, the small compartment 48 of the built-in bag 42 is formed. The drug solution bag 10 is opened, and a small amount of drug is mixed with the mixed drug solution from the compartments 26 and 28. At the same time, the outward displacement of the synthetic resin film layer due to the swelling of the chemical solution bag 10 is transmitted to the closing plug 30 as it is (mechanically) by the synthetic resin films 44-1 and 44-2, and the closing plug 30 is discharged from the discharge port 12. Withdrawn, the drug flows into the discharge port 12.

  FIG. 6 (c) shows a state after the partition wall is opened. The separated stopper plug 30 is made of plastic, has a small specific gravity, and the synthetic resin films 44-1 and 44-2 are also soft. There is no concern that it will float, be separated from the discharge port 12, and be blocked.

  FIG. 7 shows a third embodiment. In this embodiment, a coupling tool that links the closing plug 30 that closes the discharge port 12 to the swelling deformation of the drug solution bag 10 when the weak seal portion 24 (partition wall) is opened is made of synthetic resin. The link mechanism 52 is used. The link mechanism 52 includes a plate-like portion (lever) 54 integrally formed with the closing plug 30, and first and second links 56-1, 56-connected to the plate-like portion 54 so as to be rotatable about a pivot 55. 2 and pivotally connected to the first and second links 56-1 and 56-2 by pivots 58-1 and 58-2, firmly with the plastic film facing layer constituting the drug solution bag 10 (cannot be peeled off) It consists of mounting plates 60-1 and 60-2 to be welded. The pivot 55, the links 56-1 and 56-2, the pivots 58-1 and 58-2, and the mounting plates 60-1 and 60-2 are formed of the same lightweight plastic material as that of the closing plug 30. By appropriately adjusting the length ratio between the lever 54 and the links 56-1 and 56-2, the swelling deformation of the drug bag can be adjusted (amplified or reduced) and transmitted.

  FIG. 7A shows a state in which the chemical solution bag is not opened, the link mechanism 52 is in a closed state, and the closing plug 30 closes the discharge port 12.

  FIG. 7 (b) shows when the partition wall is opened. The chemical solution in the chemical solution bag 10 is pressurized from the outside, and the weak seal portion (compartment) 24 is opened. The swelling deformation of the chemical solution bag 10 due to the opening of the weak seal portion 24 is because the mounting plates 60-1 and 60-2 are firmly welded to the opposed inner layer of the chemical solution bag 10, so that the first and second links 56- 1, 56-2 is pulled outward, the closing plug 30 is detached from the discharge port 12, and the medicine is allowed to flow into the discharge port 12.

  FIG. 7C shows a state after the partition wall is opened. The separated stopper plug 30 is made of plastic and has a small specific gravity, and the stopper plug 30 is pivotally attached to the links 56-1 and 56-2 by the pivot 55. -1 and 56-2 are pivotally attached to the mounting plates 60-1 and 60-2 by pivots 58-1 and 58-2. Therefore, the closing plug 30 floats on the chemical solution in the chemical solution bag 10 and is discharged from the discharge port 12. The separation is maintained and the discharge port 12 is not blocked.

  FIG. 8 shows another embodiment. In this embodiment, an L-shaped connector is used for interlocking the stopper plug 30 for closing the discharge port 12 with the swelling deformation of the chemical bag 10 when the weak seal portion 14 (partition wall) is opened. The rigid lever 62 is used. One end of the rigid lever 62 is formed integrally with the closing plug 30, and the other end is firmly welded to the opposing surface of the drug solution bag 10 by an integrally formed plate portion 66.

  FIG. 8 (a) shows a state in which the chemical solution bag is not opened, and the discharge port 12 is closed by a closing plug 30.

  FIG. 8B shows a state when the partition wall is opened. The swelling deformation of the chemical bag 10 due to the opening of the weak seal portion displaces the rigid lever 62 outward at the welded portion with the chemical bag 10. Therefore, the closing plug 30 at the end of the rigid lever 62 is moved away from the discharge port 12, and the medicine is allowed to flow into the discharge port 12.

  FIG. 9 shows still another embodiment. In this embodiment, a closing plug 30 for closing the discharge port 12 is constituted by a thin plastic connecting plate 64 having a divergent shape. The thin connecting plate 64 is integrally extended from the stopper plug 30 at the lower end of the narrow width, and the other end of the wide width is firmly welded to the opposing surface of the drug solution bag 10 at both side edges. Further, the connection 64 forms a thin fragile portion 68 extending from the wide end edge to the root along the outer peripheral edge of the narrow stopper plug 30.

  FIG. 9A shows a state in which the chemical solution bag is not opened, and the discharge port 12 is closed by a closing plug 30.

  FIG. 9 (b) shows the time when the partition wall is opened, and the swelling deformation of the chemical bag 10 due to the opening of the weak seal portion is caused by the connecting plate 64 to be broken at the fragile portion 68. Since the welded portion 68-1 and the welded portion 68-2 are separated, the respective portions 68-1, 68-2 are displaced outwardly in conjunction with the swelling of the drug bag. The closure plug 30 integrated with 1 is removed from the discharge port 12, and the medicine is allowed to flow into the discharge port 12.

  FIG. 10 shows an embodiment in which the above-described closing plug 30 is opened along the axis of the discharge port 12, and a small amount of liquid leakage is caused through the closing plug 30, and sterilization at the time of manufacturing the multi-chamber container is performed under wet heat. It is what I did. That is, the closing plug 30 is connected to the connecting plate 32 (FIG. 1), the built-in bag 42 (FIG. 5), the link mechanism 52 (FIG. 7), the rigid lever 62 (FIG. 8), and the thin plastic through the integrated connecting portion 30-1. The connecting plate 64 (FIG. 9) is connected to a connecting tool, and the stopper plug 30 is opened in conjunction with the swelling deformation of the medicine bag at the time of opening. The stopper plug 30 is inserted into the discharge port 12 with some gap 70. Further, on the inner periphery of the discharge port 12, projections 72 and 74 for positioning the stopper plug 30 in the longitudinal direction of the discharge port 12 are provided. Although there is a small amount of liquid leakage due to the installation of the gap 70, the opening area of the gap 70 is smaller than the liquid volume at the time of normal infusion. You can notice the opening. With the opening of the chemical solution bag, the closing plug 30 is displaced upward, gets over the protrusion 74 and is removed from the discharge port 12. Liquid leakage through the gap 70 enables efficient sterilization under wet heat when manufacturing a multi-chamber container.

  In FIG. 11, an outwardly opening tapered surface 12A is provided on the inner periphery of the discharge port 12 to ensure a small amount of liquid leakage.

FIG. 1 is a plan view of a multi-chamber container according to the first embodiment of the present invention. FIG. 2 is a cross-sectional view of the multi-chamber container taken along line II-II in FIG. FIG. 3 is a partially enlarged view of the thin connecting plate in FIG. FIG. 4 is a partial view of the discharge port in FIG. FIG. 5 is a plan view of a multi-chamber container according to the second embodiment of the present invention. FIG. 6 is a schematic cross-sectional view taken along the line VI-VI in FIG. 5 and shows the operation of the multi-chamber container of the second embodiment. FIG. 7 is a partial cross-sectional view of a multi-chamber container according to another embodiment. FIG. 8 is a partial cross-sectional view of a multi-chamber container according to still another embodiment. FIG. 9 is a partial sectional view of a multi-chamber container according to still another embodiment. FIG. 10 is a view for explaining the positional relationship of the closure plug according to another embodiment of the multi-chamber container of the present invention with respect to the discharge port. FIG. 11 is similar to FIG. 10 but shows yet another embodiment of a closure plug.

Explanation of symbols

DESCRIPTION OF SYMBOLS 10 ... Drug bag 12 ... Discharge port 14 ... Strong seal part 20 ... Rubber stopper 24 ... Weak seal part (partition wall of this invention)
26, 28 ... 1st and 2nd compartment 30 ... Closure stopper 32 ... Thin connection board (connector of this invention)
34 ... Slit
36-1, 36-2 ... 1st and 2nd connecting part
38-1, 38-2 ... Welding part 42 ... Built-in bag
44-1, 44-2 ... Upper and lower synthetic resin films 52 forming a built-in bag ... Synthetic resin link mechanism 62 ... Rigid lever 64 ... Thin plastic connecting plate 68 ... Thin fragile portion

Claims (3)

  A drug bag formed of a soft film, a partition wall that separates the inside of the drug bag into a plurality of compartments by welding the opposite surfaces of the drug solution bag so as to be capable of being pressure-released, and one end fixed to the drug solution bag A discharge port that extends into the bag and has a stopper for puncture at the other end located outside the drug solution bag, and is movably provided at the one end of the discharge port that extends into the drug bag, Normally, the closing member inserted into the one end of the discharge port, and the softening that constitutes the chemical bag to move the closing member away from the discharge port in conjunction with the expansion of the chemical bag when the partition wall is opened A multi-chamber container composed of a connector connected to the inner surface of the film by welding.   2. The multi-chamber container according to claim 1, wherein an appropriate gap is provided in an insertion portion at one end of the closing member with respect to the discharge port.   In the invention according to claim 1 or 2, the connector is constituted by an appropriate mechanism means such as a thin plate member, a link, a lever, a string-like body, etc., and the chemical bag expansion displacement at the time of opening the partition wall is left as it is. Alternatively, a multi-chamber container that is amplified and transmitted to the closure member.

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