JP2007130358A - Medical multi-chamber container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical multi-chamber container having a structure wherein a communication structure is linked with a hanging release structure without bending a hanging part and a discharge port and the administration of a medicament to a patient is avoided in a non-communication state. <P>SOLUTION: The medical multi-chamber container including the medicament comprises: a flexible container body which is liquid-tightly divided into at least two medicament chambers with the use of a separable weak seal part, where the medicament is sealed respectively in the chambers; a port communicating with one medicament chamber of the container body; the hanging means arranged so as to allow the port to be positioned at the lowest place in hanging after performing communication in each medicament chamber; and a container hanging preventing means which is arranged so as to allow the container hanging means not to be used in the non-communication state before performing communication. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a medical multi-chamber container. Specifically, the present invention relates to a medical multi-chamber container that cannot be used in an unconnected state.

  There are drugs and chemicals that have poor storability due to alteration when stored in a premixed state. These drugs and drug solutions are stored separately and mixed and used by aseptic mixing immediately before use. A medical multi-chamber container is used to store drugs and chemical solutions individually during storage and to aseptically mix these drugs and chemical solutions during use.

  This is because a plurality of medicines and chemical solutions are stored separately in a plurality of chambers partitioned by weak seal parts that can be easily peeled off, and the weak seal parts are removed by pressing the container by hand immediately before drug administration. The contents are exfoliated and the contents are mixed or dissolved under aseptic conditions by communicating with a plurality of chambers.

  However, the conventional medical multi-chamber container does not have a method of distinguishing whether or not a plurality of chambers communicate with each other, and is generally distinguished visually. For this reason, it has been reported that a drug enclosed in a medical multi-chamber container is administered to a patient without communication.

  In order to avoid the administration of the drug from the multi-chamber container to the patient in such a disconnected state, a mechanism that does not administer the drug in the disconnected state has been proposed. For example, by closing the suspending hole with a seal for confirmation of opening, a warning is issued so as not to administer the drug from a non-communication multi-chamber container (Patent Document 1).

In addition, when the plurality of drug chambers are not in communication, the suspending portion and the discharge port are fixed to be unusable (folded) by the adhesive seal, and the adhesive seal can be peeled off by connecting the plurality of drug chambers. There is also one that avoids drug administration to a patient in an uncommitted state by enabling the lowering portion and the discharge port (Patent Document 2).

Utility model registration No. 3074885 JP2005-218661

  However, in the structure such as Patent Document 1 in which a tapping confirmation seal is attached to the suspension hole to close the suspension hole, it is merely a reminder, and the tapping confirmation seal is linked to the communication structure. Since it can be used by removing the seal for confirmation of opening even in a non-communication state, there is a possibility that a medicine not prepared from a multi-chamber container in an uncommunication state may be administered to a patient. . Further, in the structure in which the hanging portion and the discharge port are bent and fixed to the container side by an adhesive seal as in Patent Document 2, the adhesive seal is peeled off due to insufficient deterioration of the adhesive seal or insufficient adhesion of the adhesive seal. There is a risk of recognizing that the communication state is established despite the communication. Also, it is difficult to set each seal strength in terms of processing. This is because, when the hanging part side is bent and fixed, for example, when a powder preparation is sealed in the uppermost drug chamber, the upper drug chamber does not have a large expansion rate, so that the adhesive force of the adhesive seal is increased. Then, it is difficult to give a peeling force to the adhesive seal. If the adhesive force is weakened, the adhesive seal may be peeled off by some impact or the like even before communication. When the discharge port is bent and fixed, the relationship between the weak seal strength of the communicating portion and the adhesive seal strength for fixing the discharge port is determined so that the adhesive seal does not peel until the weak seal peels, and the weak seal is This is because when peeled and communicated, the adhesive seal must be processed to such a strength that it can be peeled off quickly. In addition, there is a risk that pressure is applied to the weak seal part without permission when the discharge port is bent, and communication may occur, or the discharge port bent at the time of communication may interfere with the pressure on the container. . Therefore, there is a need for a structure in which the communication structure and the suspension release structure are linked without bending the hanging part and the discharge port, so that drug administration to a patient without communication can be avoided.

  An object of the present invention is to provide a medical multi-chamber container in which each chamber is unusable when not in communication.

Therefore, the present inventors
(1) A medical multi-chamber container containing a medicine, which is liquid-tightly divided into at least two medicine chambers by a peelable weak seal portion, and each medicine chamber is filled with a medicine. A container main body, a port communicating with one of the drug chambers of the container main body, and a suspension means provided so that the port is positioned at the bottom when the drug chamber is suspended after communication. A medical multi-chamber container comprising container suspending prevention means provided before the container suspending means is disabled when not connected.
(2) The medical multi-chamber container according to (1), wherein the container suspending means is provided in the container body.
(3) The medical multi-chamber container according to (1), wherein the container suspension means is provided in the container suspension prevention means.
(4) The medical multi-chamber container according to (1) to (3), wherein the container suspension preventing means is a pinching member for pinching one drug chamber.
(5) The medical multi-chamber container according to any one of (1) to (4), wherein the gripping member is a single member.
(6) The multi-chamber container for medical use according to (1) to (4), wherein the gripping member is a member in which the first member and the second member are connected by a connecting portion that can be bent.
(7) The medical multi-chamber container according to (1) to (4) and (6), wherein the first member, the second member, and the connecting portion of the gripping member are integrally molded. .
(8) The container suspension means is formed on the first member or the second member of the gripping member, and another member not provided with the container suspension means is fixed to the container body. The medical multi-chamber container according to (1), (3), (4), (6) and (7).
(9) By using the medical multi-chamber container according to any one of (1) to (8), wherein the gripping member is formed of a transparent member or a semi-transparent member, the container suspending preventing means is a medical multi-chamber container When the chambers are not in communication with each other, the container suspension means is provided so that the container suspension prevention means is released when the chambers communicate with each other. The structure for releasing the lowering prevention means is a linked structure, making it impossible to use each chamber of the medical multi-chamber container in an uncommitted state, avoiding the risk of administering unprepared drugs to the patient, When all the chambers of the medical multi-chamber container communicated with each other, it was found that the medical multi-chamber container can be used quickly, and the present invention has been achieved.

  As described above, the medical multi-chamber container of the present invention cannot be suspended in a non-communication state because it is provided with a container suspension prevention means that obstructs the suspension structure in the non-communication state. Therefore, the unadjusted drug that is not in communication is not erroneously administered to the patient, and thus can be suitably used for medical treatment.

  FIG. 1 is a diagram of an embodiment of the medical multi-chamber container, the medical multi-chamber container, and the container suspension preventing means of the present invention. FIG. 2 is a diagram of another embodiment of the medical multi-chamber container, the medical multi-chamber container, and the container suspension preventing means of the present invention. 3 (a) and 3 (b) are perspective views of an embodiment of the non-communication suspension preventing means. FIG. 4 is a side view of the method for using the medical multi-chamber container shown in FIG.

  FIG. 1 shows a medical multi-chamber container including a multi-chamber container body A composed of a first drug chamber 1 and a second drug chamber 2, a port 3 and a clip 4. The container main body A is a bag-shaped second drug chamber 1 formed from a tubular film and a bag-shaped second formed by bonding the peripheral edges except for one side of the front sheet and the rear sheet that are laminated films. The drug chamber 2 is connected so that the first drug chamber 1 and the second drug chamber 2 communicate with each other, and a weak seal portion 5 is formed inside the connection between the first drug chamber 1 and the second drug chamber 2. And a flexible multi-chamber container in which the first drug chamber 1 and the second drug chamber 2 are partitioned in a liquid-tight manner by the weak seal portion 5. A drug solution is sealed in the first drug chamber 1 and a powder formulation is sealed in the second drug chamber 2. A suspension hole 6 that is a container suspension means is provided in the upper part of the container body A, and the lower end of the container body A that is positioned symmetrically with the suspension hole 6 communicates with the first drug chamber 1. The port 3 closed by the rubber plug 31 is provided so that the axis is substantially in the direction of gravity when the container body is suspended. The clip 4 as a gripping member is used as a container suspension prevention means so as to cover the suspension hole 6 from the front and rear surfaces and sandwich both surfaces of the second drug chamber 2, and sandwich the container body A from the upper end of the container body A. I'm grabbing. The clip 4 has a structure in which a plate-like front board 41 and a rear board 42 which are a first member and a second member are connected by a hinge part which is a bendable connecting part. The second member and the connecting portion are integrally molded. The locking portion 431 and the locked portion 432 which are the gripping means 43 provided on the surfaces of the front board and the rear board of the clip 4 which are located on the inner side when the clip is gripped by the container body are respectively provided in the hanging hole 6. It is engaged to pass through. The slip prevention 45, which is an arc-shaped convex portion provided on the rear board 42, is because the clip does not slip from the suspension hole 6. The clip 4 is clamped by the container body A by the engagement of the lock portion 431 and the locked portion 432, and the front board 41 and the rear board 42 of the clip are attached so as to cover the second medicine chamber 2. .

  The clip 4 presses the first drug chamber 1 so that the first drug chamber 1 and the second drug chamber 2 communicate with each other, and the second drug chamber 2 expands to cause the front board 41 and the rear board 42 to expand. In response to the expansion of the second drug chamber 2, each of the boards receives a force in a direction away from each other, so that the lock portion 431 and the locked portion 432 are disengaged and the clip 4 is released. In this way, the clip 4 is connected to the first drug chamber 1 and the second drug chamber 2, and when the second drug chamber 2 expands, a force is applied in a direction in which the front board 41 and the rear board 42 are separated. Since the clip 4 of the second drug chamber 2 comes off, the clip 4 does not come off when the second drug chamber 2 is not expanded, that is, the second drug chamber 2 does not expand, and the first drug chamber 1 and the second drug chamber 2 By connecting 2, the clip 4 is detached and the container body A can be suspended. Accordingly, since the suspension hole 6 does not appear when the clip 4 is blocked by the clip 4 in a non-communication state, it cannot be hung on a stand or the like. Therefore, the suspension hole 6 is not used in a non-communication state. Further, the second drug chamber 2 is expanded by the communication of the liquid and the clip 4 is detached, and the communication structure and the suspension release structure are linked.

  FIG. 2 shows another embodiment of the present invention. A hanger portion 47 that is a container suspension means is formed on the front board 41 of the clip 4. The rear board 42 is engaged with the coupling portion 421 of the rear board 42 and the coupled portion 461 of the fixed piece 46 so that the suspension hole 6 passes through, so that the clip 4 is attached to the container body A, and the front board 41 The lock portion 431 formed on the board 41 engages with the locked portion 432 formed on the rear board 42, whereby the front board 41 and the rear board 42 pinch the container body A. Since the fixed piece 46 is disposed so as not to hang over the second drug chamber 2, the clip 4 does not disengage from the fixed piece 46 even when the second drug chamber 2 expands. Remains attached. In this way, the clip 4 is bent and attached, the hanger portion 47 is in contact with the container body A, and one side of the clip 4 is covered to serve as a container suspension preventing means, and at the same time, the front board 41 and the rear board When the gripping of 42 is released, the front board 41 is separated from the container main body A, and the clip 4 serves as a container hanging means. At the time of releasing the container suspension preventing means of the clip 4, the engagement between the fixed piece 46 and the rear board 42 is not released, so that the clip 4 is not separated or dropped from the container body A. Here, the method of fixing the clip 4 to the container body A is not limited to the shape shown in FIG. 2 as long as the clip 4 can be fixed, and the rear board 42 and the container body A are fixed with a pin or the like. May be. The structure of the clip 4 and the hanger part 47 may be such that the front board 41 is fixed to the container body A and the hanger part 47 is formed on the rear board 43. The hanger portion 47 that is the hanging means is not limited to the hole shape, and may be a hook shape. However, the hole shape is preferable because there is no fear of dropping from the stand. When the hanging hole 6 provided in the container main body A is not suitable for attaching the clip, or when the hanging hole 6 does not exist in the container main body A, the plate-like member on the side where the hanger portion 47 is not formed is used as the container. Although it may be fastened directly to the main body A with a pin or the like, at this time, the hanging hole 6 of the container main body A is left unusable. In addition, in the case of the above type in which the hanger part 47 is formed in the container suspending means, the suspending hole 6 provided in the container main body A is not used as the container suspending means. Therefore, the container body A may not have the hanging hole 6.

  The type in which the clip is separated as shown in FIG. 1 is stable because the hanging hole is formed in the container main body, and unnecessary dust is not generated by adopting a structure in which the clip is not separated as shown in FIG.

  The clip 4 is a pinching member that serves as a container suspension preventing means. The first member and the second member are connected by a connecting portion that can be bent. In the above embodiment, the connecting portion 44 is formed of a hinge portion, and the two plate-like members and the hinge portion are formed by integral molding. However, if the pinching member acts as a container suspension preventing means, the connecting portion 44 is not limited to the hinge portion, and may not be integrally molded. For example, two members may be connected by a seal or a hinge.

  The clip 4 is not particularly limited as long as it has a shape and material that do not hinder display of the display label. Although it is possible to make the display label in a shape that does not overlap with the clip 4 in advance, when the clip 4 is clamped by the container body A so that it can be widely used for medical multi-chamber containers, printing under the clip through the clip 4 is possible. It is preferable that the display label is made of a material having transparency so that it can be read. Furthermore, it is particularly preferable that the display label side is made of a material having the transparency and the content medicine confirmation side is made of an opaque material. This is because by making the content medicine confirmation side opaque, the visual confirmation of the content medicine can be hindered and attention can be drawn, so that use in an unconnected state can be avoided. At this time, since the clip does not block all the places where the medicine in the medicine chamber is visually confirmed, the medicine cannot be confirmed. In the case of FIG. 2 in which the clip is used for hanging, the shape and material are not particularly limited as long as the clip has strength sufficient to withstand the weight of the medicine container containing the medicine.

  The engagement shape of the lock portion 431 and the locked portion 432 of the clip 4 is not particularly limited as long as it is a shape that can be removed by receiving the expansion of the uppermost chamber other than the crank-type lock mechanism shown in FIG. In addition, as shown in FIG. 3 (b), it may be of a type that engages with prevention of displacement, or a shape in which buttons are fitted as shown in FIG. 3 (c). In addition, the clip which is a member of the medical multi-chamber container of the present invention is not limited to the medical multi-chamber container of the present invention, even a conventional multi-chamber container which does not have a peelable light shielding aluminum cover sheet. The effect of preventing uncommunication can be obtained by attaching the to the suspension hole.

  The slip prevention 45 provided on the clip 4 is formed on the container body A when a strong force is applied in the lateral direction of the clip in a state where the clip 4 is gripping the container body A. This is to prevent the suspended hole 6 from being exposed. Even if the slip prevention 45 is not provided, the suspension hole 6 may not be exposed even if the clip 4 is displaced, and for example, a board may be formed widely. The displacement prevention 45 is preferably a convex portion having substantially the same shape as the suspension hole 6 formed in the container main body A. Providing the protrusion 45 with substantially the same shape as the suspension hole 6 increases the stability of mounting the clip to the container body, and therefore prevents the clip from shifting from the initial mounting position to the container body due to force majeure. Is possible.

  In addition to the method using the clip, as a gripping member for the container suspension preventing means, the container suspension preventing means can be released by the expansion of the second drug chamber after the chambers of the container body communicate with each other. If it is. For example, the second drug chamber expands and breaks, such as a disposable chopstick, or an elastic plate-like member that restores from a bent state to an extended state when it is unattached, and a lock part and a locked part are provided. You may use what is formed like a clip and made to be bent and forcibly attached to a container main body. Even in this case, it is preferable to form a shift prevention for the above reason.

  The material of the drug chamber is not particularly limited as long as the drug can be stably stored, and is usually formed of a synthetic resin film used for a drug bag. When the drug is a powder, it is preferable that the drug can be stably stored, has gas / moisture barrier properties, and has excellent bag strength, and has an innermost layer that comes into contact with the drug when the film is formed into a bag shape. Polyethylene and cyclic polyolefin that can stably store chemicals, vapor-deposited polyethylene terephthalate with an intermediate layer that blocks moisture and gas, and excellent printing strength, and the outermost layer on the outside is polyethylene or polyethylene terephthalate with excellent bag-making properties. It is particularly preferable to use a laminated film to be formed. By laminating films in this way, it is possible to block moisture and gas that are going to permeate the synthetic resin. When the drug is a liquid, it is preferable to use polyethylene that is resistant to low temperature impact and excellent in flexibility.

  In the container body A, the first drug chamber 1 is formed from a cylindrical film, and the second drug chamber 2 is formed by bonding sheets. In the case of FIG. 1, since the liquid medicine is sealed in the first medicine chamber and the solid (powder) preparation is sealed in the second medicine chamber, it is necessary to change the laminated material of the film suitable for medicine storage. One drug chamber and a second drug chamber are separately manufactured and connected to form a container body. However, the structure of the container body is not limited to that shown in FIG. 1 as long as the medicine sealed in the medicine chamber can be stably stored for a long period of time. For example, if it is not necessary to use a laminated film in the second drug chamber, the second drug chamber may be formed from a cylindrical film, or the drug sealed in the first drug chamber and the second drug chamber. When the laminated film of the same material is suitable, the container main body A may be formed by integral molding and partitioned by a weak seal portion so as to form a multiple chamber. Further, if necessary for manufacturing such as balance with the weak seal portion, a film formed by dividing the front seat and the rear seat may be bonded.

  When using chemicals and chemicals that deteriorate or deteriorate when exposed to light, a film having a light shielding property is laminated on the film forming the chemical chamber. Normally, one side of the drug room is formed with a laminated film with an aluminum foil layer added, and the other side is formed with a laminated film without an aluminum foil layer, and the laminated film with no aluminum foil layer added. On the side, a cover sheet made of peelable aluminum and polyethylene terephthalate is coated. This is in order to avoid using the double-sided aluminum foil layer without observing the sealed drug state and not knowing the alteration. Since the visual confirmation of the medicine is performed before communication, it is not possible to use this when the clip is shaped to hang on the second medicine chamber like the medical multi-chamber container of the present invention. By making the sheet shape concave so that the clips can be peeled without overlapping, or by laminating a material that has light shielding properties and transparency enough to confirm the internal drug state on the sheet Can be used. In addition, it is possible to preserve light by storing the multi-chamber medical container of the present invention in a colored polyethylene terephthalate bag during storage, so a light-shielding sheet is laminated on the container body. Even if the product is not used, it is possible to use a drug that is altered or deteriorated by light. By using the above method, the medical multi-chamber container of the present invention can be used even for drugs that need to be stored in the dark.

  The drug enclosed in the second drug chamber is a powder formulation, but a drug solution may be sealed as long as the clip is in an unconnected state with the second drug chamber so that the clip does not come off. In particular, it is preferable that the drug enclosed in the second drug chamber is a powder formulation because the clip can be stably held because there is almost no expansion change due to movement of the drug in the second drug chamber.

  The structure of the weak seal 5 is not particularly limited as long as each drug chamber can be partitioned in a liquid-tight manner, and each drug chamber can be communicated quickly when the container is pressed. For example, when a weak seal portion is formed by biting a weak seal portion forming sheet into the weak seal portion, the innermost layer material and a resin having low welding strength are usually used for the sheet. For example, when the innermost layer is polyethylene, a polymer blend in which polyethylene and polypropylene are mixed at 3: 7 to 7: 3 is suitably employed. By using the resin of the innermost layer and the resin having a weak welding strength, weak seals are possible because the portions not welded to the innermost layer are scattered in the weak seal portion. When the innermost layer is a polymer blend of polyethylene and polypropylene, the container body is welded at 200 to 250 ° C., and the weak seal portion forming sheet is welded at around 120 ° C. to form a weak seal portion. Thus, it is possible to achieve a structure in which only the weak seal portion can be peeled without peeling off the peripheral edge of the container due to pressing during communication.

  The port 3 is a cylindrical body, and a plug is attached to the port lower opening. Usually, isoprene rubber, butadiene rubber or the like is used as the rubber of the plug.

  A method of using the medical multi-chamber container shown in FIG. 1 will be described with reference to FIG. First, the first drug chamber 1 is pressed from the outside, the weak seal portion 5 is peeled off, and the first drug chamber 1 and the second drug chamber 2 are communicated. By communicating, the medicine in the first medicine chamber 1 moves to the second medicine chamber 2 and the volume of the second medicine chamber 2 increases. Therefore, since the second drug chamber 2 expands and has a thickness, the clip 4 holding the container main body A is detached, and the clip 4 and the container main body A can be separated and are covered by the clip 4. The hanging hole 6 is exposed. In this way, by using the non-communication suspension preventing means as a gripping member, the medicine chamber containing the chemical solution that is not the uppermost chamber is pressed to communicate with all the chambers, and the chemical solution flows into the uppermost chamber and expands. Utilized, the communication means and the suspension means are linked. By adopting the above-described structure, the non-communication suspension means is not released until the multiple chambers communicate with each other, so that the container cannot be suspended, and there is no possibility of administering the drug solution to the patient in an uncommitted state.

  As described above, the medical multi-chamber container of the present invention cannot be suspended in a non-communication state because it is provided with a container suspension prevention means that obstructs the suspension structure in the non-communication state. Therefore, the unadjusted drug that is not in communication is not erroneously administered to the patient, and thus can be suitably used for medical treatment.

The figure of the one embodiment example about the medical multiple-chamber container and container suspension prevention means of this invention. The figure of the other example of an embodiment about the medical multiple-chamber container and container suspension prevention means of this invention. (A), (b) The perspective view of the embodiment example about a non-communication suspension prevention means. The side view about the usage method of the medical multiple-chamber container shown by FIG.

Explanation of symbols

A Container body 1 First drug chamber 2 Second drug chamber 3 Port 31 Plug body 4 Clip 41 Front board 42 Rear board 421 Joint part 43 Grasping means 431 Lock part 432 Locked part 44 Linking part 45 Deviation prevention 46 Fixed piece 461 To-be-joined part 47 Hanger part 5 Weak seal part 6 Hanging hole

Claims (10)

A medical multi-chamber container containing a medicine,
A flexible container body that is liquid-tightly divided into at least two drug chambers by a peelable weak seal portion, and each drug chamber is filled with a drug;
A port communicating with one of the drug chambers of the container body;
Suspension means provided so that the port is located at the lowest position when suspended after each of the drug rooms communicates,
Before the communication, the container suspension means is provided with a container suspension prevention means provided to be disabled when not connected,
Medical multi-chamber container.   The medical multi-chamber container according to claim 1, wherein the container suspending means is provided in the container main body.   The medical multi-chamber container according to claim 1, wherein the container suspension means is provided in the container suspension prevention means.   4. The medical multi-chamber container according to claim 1, wherein the container suspension preventing means is a pinching member for pinching one of the drug chambers.   The medical multi-chamber container according to claim 1, wherein the pinching member is made of one member.   5. The medical multi-chamber container according to claim 1, wherein the gripping member is a member in which the first member and the second member are connected by a connecting portion that can be bent.   The medical multi-chamber container according to any one of claims 1 to 4 and 6, wherein the first member, the second member, and the connecting portion of the grasping member are integrally molded.   The container holding means is formed on the first member of the gripping member, and the second member is fixed to the container body. Medical multi-chamber container.   The container holding means is formed on the second member of the gripping member, and the first member is fixed to the container body. Medical multi-chamber container.   The medical multi-chamber container according to claim 1, wherein the pinching member is formed of a transparent member or a translucent member.

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