JP3108884B2 - Aseptic holding and mixing device for two drugs housed in individually sealed containers - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for mixing two kinds of drugs, which are individually sealed and housed, under aseptic conditions.

[0002]

BACKGROUND OF THE INVENTION When a drug is administered to a patient at a medical institution such as a hospital by drip injection or the like, a drug such as an antibiotic sealed in a vial is dissolved and administered with a drug such as a physiological saline solution or a glucose solution. . At this time, if these drugs are mixed and dissolved, they tend to be unstable, and lose their efficacy in a relatively short time. Therefore, the mixing operation of the drugs is performed immediately before administration.

Conventionally, this mixing operation is carried out by the following procedure using a medicine and a syringe which are separately supplied.
Unpack and prepare the packages for both drugs and the syringe. The liquid container is opened such as by opening the ampoule, and the dissolving drug in the liquid container is inhaled with a syringe.
The injection needle is pierced through the rubber stopper of the vial, and the dissolving agent is injected. Shake the vial to dissolve the antibiotic in the vial. Both dissolved drugs are inhaled into a syringe and prepared for administration to a patient.

However, the above mixing operation has the following problems. I. The unpacked syringe is exposed directly to the outside air and is easily contaminated with various bacteria. Moreover, since the needle of this syringe is inserted into the container to transport and mix the drug, there is a possibility that the mixed drug may be mixed with bacteria. B. Both the drug and the syringe, which are supplied separately, must be prepared by unpacking, and the surface of the rubber stopper through which the needle of the syringe penetrates must be sterilized. In addition, the liquid drug is once drawn into the syringe. The mixing operation is extremely complicated. C. Since the drugs contained in separate containers are mixed immediately before administration, complicated operations must be performed in a short time,
There is a possibility that the combination of the mixed drugs is mistaken. D. Liquid drugs are often sealed in ampoules, in which case the glass chips generated when opening the ampoule are liable to be mixed into the drug, and the drug directly comes into contact with the outside air, which may result in contamination by bacteria. Many.

[0005]

2. Description of the Related Art In order to solve the above-mentioned problem and to mix two kinds of drugs by a simple operation, Japanese Patent Application Laid-Open No.
No. 81947 proposes a mixing device.

As shown in FIG. 6, this mixing device comprises a single medicine container, a lower first container chamber (1) in which a first medicine is sealed and accommodated, and an upper second container chamber, in which a second medicine is sealed and accommodated. Container room
And (2) are connected and connected at a central container connecting portion (3). Then, a partition stopper is inserted in the container connecting portion (3).
(4) is slidably fitted inside and fixed in the first container chamber (1) and the second container chamber (1).
The communication with the inside of the container chamber (2) is sealed. Second container room (2)
A pressing mechanism (31) is provided in the upper part of the container so as to block the outside air. As shown in the right half of FIG. 6, the pressing mechanism (31) is slid in an airtight manner on the inner surface of the second container chamber (2). By the second container room
(2) The pressing portion (32) disposed inside is moved downward, and the partition plug (4) attached to the lower end of the pressing portion (32) is moved to the first container chamber (1).
It is configured so that it is pushed to the side and the above-mentioned seal is released to mix the two drugs.

[0007]

However, in the mixing apparatus described above, the first container chamber (1) and the second container chamber (2) are formed in a single drug container integrated at a connecting portion. ,
In order for the two container chambers (1 and 2) to communicate with each other, the partition stopper (4) disposed inside must be slid by remotely operating the container from outside the container. It is necessary to provide a complicated pressing mechanism (31) above 2).

In addition, the pressing mechanism (31) has to slide hermetically with respect to the second container chamber (2) because it is necessary to hold both drugs under aseptic conditions. 4) is combined with the resistance to slide on the sliding surface (5) in the container connecting part (3), the sliding resistance is increased, and a strong operating force is required to connect the two container chambers (1.2). There was a problem.

In general, powder drugs such as antibiotics are supplied from a different drug supplier than a liquid drug for dissolution. In this case, two drugs are placed in one drug container while maintaining a sterile condition. It is extremely difficult to partition with a partition stopper, seal them, and further assemble a pressing mechanism.

The present invention has been made in view of such a point. The partition plug provided in the container connecting portion can be slid by a simple operation, and the two containers can be easily communicated with each other. Another object of the present invention is to provide an aseptic holding and mixing device for two drugs contained in individually sealed containers in which the entire device has a simple structure.

[0011]

According to the present invention, in order to achieve the above object, the container connecting portion (3) is connected to a first container side connecting portion (3a) and a second container side connecting portion (3b). And the two connecting portions (3a, 3b) are connected via the partition plug (4), and a communication passage (6) is provided inside the partition plug (4). The road end (7) of (6) is connected to the container connecting part (3)
Opening facing the inner sliding surface (5), the first container (1)
And the second container (2) are pushed toward each other so that the partition plug (4) hermetically slides on the sliding surface (5), and the road facing the sliding surface (5). The end (7) is configured to enter the container and open.

[0012]

Since the communication passage provided inside the partition plug is blocked at the road end facing the sliding surface of the inner surface of the container connecting portion, the inside of each container is maintained in an airtight and sterile state. When mixing two kinds of medicines, only the operation of pushing the first container and the second container in the direction of approaching each other causes the road end of the communication passage provided in the partition stopper to enter and open into the container, and this communication passage is opened. The two containers communicate with each other via the. And, while the road end of the communication passage moves from the position facing the sliding surface to the position opening into the container, the partitioning stopper slides hermetically on the inner surface of the container connecting portion, so that both containers are always shut off from the outside air. Thus, the two drugs are mixed while maintaining the sterility.

[0013]

Embodiments of the present invention will be described below with reference to the drawings. 1 to 3 show a first embodiment of the present invention. FIG. 1 is a longitudinal sectional view of a mixing apparatus, FIG. 2 is a longitudinal sectional view of a state in which both containers are communicated with each other, and FIG. FIG.

As shown in FIG. 1, this aseptic holding and mixing apparatus has a first container (1) in which a solution such as physiological saline is hermetically sealed, and an upper part of the first container (1) A lower part of a second container (2) containing a second drug such as an antibiotic is communicatively connected via a container connecting part (3). In addition, the first container
A rubber stopper (28) for piercing the injection needle on the container side of the drip set is attached to the lower part of (1), and the second container (2)
Is sealed with a sealing lid (9).

The container connecting portion (3) is connected to the first container-side connecting portion (3).
a) and a second container-side connecting portion (3b),
The lower part of the partition plug (4) is fitted in the container-side connection part (3a), and the upper part of the partition plug (4) is fitted in the second container-side connection part (3b) so as to be airtightly slidable. I have.

The middle partition plug (4) has an annular projection (10) formed on the outer surface at the center in the vertical direction. The first container (1) and the second container (2) are connected to the connecting portions (3a, 3b), respectively.
The end (11) of the container (1 · 1) is spaced apart from the protrusion (10), and a spacer (12) is mounted in the gap.
2) is kept away from each other.

The partition plug (4) is provided with a single vertically extending communication path (6) therein, and the lower end (7a) of the communication path (6) is connected to the first container side. Sliding surface of part (3a) (5a)
In addition, the upper end (7b) is on the sliding surface (5b) of the second container side connecting portion (3b),
Each one is open. Therefore, this communication passage
In (6), both road ends (7a and 7b) are closed by the sliding surface (5) with the container connecting portion (3), and the inside of the first container (1) and the second container (2) Communication with the inside is cut off.

Next, the procedure of the mixing operation will be described.
The communication operation between the first container (1) and the second container (2) is performed by removing the spacer (12) attached around the container connecting portion (3), and then connecting both containers (1.2). This is performed by squeezing each of them and pushing them toward each other. By this operation, the partition plug (4) slides on the inner peripheral surface of the container connecting portion (3), and as shown in FIG.
The end (11) of b) abuts on the annular protrusion (10), and the lower end of the partition plug (4) is in the first container (1) and the upper end is in the second container (2). Respectively, and both road ends (7a, 7b) of the communication path (6) are opened in each container (1, 2).

By the above operation, the inside of the first container (1) and the second
When the inside of the container (2) is communicated via the communication path (6), the solution in the first container (1) is partially moved into the second container (2) to dissolve the second drug in the container. And let this solution communicate again
It is moved into the first container (1) through (6) to complete the mixing of both drugs under aseptic conditions.

All of the mixed medicines are transferred into the first container (1), and as shown in FIG. 3, an infusion set (26) is placed in an infusion rubber stopper (28) provided at the lower part of the first container (1). ) Is inserted into the container side needle (27) and used for instillation. The rubber stopper for this drip is
Instead of being provided at the bottom of the first container (1), a sealing lid (9) at the upper end of the second container (2) may be used. The first container
From (1), it is sent to the infusion set (26) through the communication path (6) and the second container (2).

When the mixed drug is inhaled into a syringe and administered to a patient, both containers (1) are connected via the communication path (6).
(2) After the inside is communicated, the solution is moved into the second container (2), and the solution in which the second drug is dissolved can be directly sucked into the syringe and used.

FIG. 4 shows a second embodiment, in which a communication path (6) provided in a partition plug (4) connects an upper road end (7) to a second container side as shown in the left half figure. An opening faces the sliding surface (5) on the inner surface of the portion (3b), and the communication path (6) is sealed with the sliding surface (5). On the other hand, the lower road end of this communication passage (6)
(8) is always open facing the container of the first container (1) and is not sealed. In addition, the first container side connection part (3a)
Is hermetically fixed to the partition plug (4).

The spacer (12) is fixed by a case (13) shown by a virtual line so as not to be mistakenly removed in a distribution process or the like. In the second embodiment, the upper road end (7) faces the sliding surface (5), and the lower road end (8) faces the first container (1). The lower road end is connected to the first container side
With the upper road end facing the sliding surface (5) of (3a), the second container
(2), and the second container-side connecting portion (3b) may be air-tightly fixed to the partition plug (4).

The other structure is the same as that of the first embodiment. After removing the case (13), as shown in the right half figure, the same operation as that of the first embodiment is performed, so that each container (1. 3)
The inside is communicated, and the two stored drugs are mixed under aseptic conditions.

With the above construction, the partition plug (4)
The inner communication passage (6) may be opened with only one road end (7) facing the sliding surface (5), so that the structure of the partition plug (4) can be simplified and the sliding surface can be simplified. Since there is only one (5), the communication operation can be performed with a lighter operating force.

FIG. 5 shows a third embodiment, in which two communication passages (6A and 6B) are formed in the partition plug (4). As shown in the left half figure, these communication passages (6A, 6B) are formed such that the lower road end (7a) of the first communication passage (6A) is a sliding surface of the inner surface of the first container-side connecting portion (3a). (Five
a) is open facing the upper side (8A) of the second container
(2) It is open facing the inside. Also, the second communication passage (6B)
In contrast to the first communication path (6A), the upper road end (7b) is open facing the sliding surface (5b) of the inner surface of the second container side connection part (3b), The road end (8B) is open toward the first container (1).

The first container-side connecting portion (3a) is a first container
It is formed separately from (1) and is screwed into the container mouth (1a) in an airtight manner. With this configuration, the second
When the partition plug (4) is attached to the second container (2) containing the medicine, and the first container side connecting portion (3a) is fitted to the partition plug (4), the first communication passage is formed. (6A) is also sealed, the second container
(2) can be sealed alone. As a result, when assembling the second container (2) to the container opening (1a) of the first container (1), an aseptic state can be easily maintained.

The other structure is the same as that of the first embodiment. Two kinds of medicines are mixed by the same operation as that of the first embodiment. From the inside of the first container (1) through the single passage (6A), the second container
While moving into (2), the first container (1) is configured such that the gas component in the second container (2) passes through the second communication passage (6B), which is the other communication passage, and is replaced with the liquid medicine. Flows into the interior. As a result, the liquid medicine can move very smoothly between the containers, and the two kinds of medicines can be easily mixed.

[0029]

According to the present invention, the following effects can be obtained from the configuration and operation described above. By simply pushing the first container and the second container in directions approaching each other, the partition plug slides on the inner surface of the container connecting portion, so that a pressing mechanism or the like for moving the partition plug is not required, and the mixing device is not used. Can have a simple structure and can be implemented at low cost.

In addition, the communication operation requires only a simple operation of bringing both containers close to each other, and the road end of the communication passage can be airtightly slid simply by firmly gripping and pushing the two containers. The two drugs can be mixed very easily as is.

Further, since the first container and the second container are formed separately, it is possible to use drug containers adapted to the respective properties of the two kinds of stored drugs. Therefore, for example, in the case where one drug is apt to be degraded due to moisture absorption, only the container containing this drug may be formed in the moisture-proof container.
As the other drug container, a general plastic bottle or the like can be used, and the manufacturing cost can be reduced. Furthermore, even when the drug suppliers are different, each drug is stored in a separate container, so that the aseptic condition can be easily maintained at the time of assembly.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a mixing device, showing Example 1 of the present invention.

FIG. 2 is a vertical cross-sectional view of a state where the insides of both containers of Example 1 are communicated with each other.

FIG. 3 is a front view showing a state in which an infusion set is attached to the mixing device of the first embodiment.

FIG. 4 is a longitudinal sectional view of the mixing apparatus of Example 2, wherein the left half shows a state before the mixing operation, and the right half shows a state after the mixing operation.

FIG. 5 is a diagram corresponding to FIG. 4 of the third embodiment.

FIG. 6 is a diagram corresponding to FIG. 4, showing a conventional example.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... 1st container, 2 ... 2nd container, 3 ... Container connection part,
3a: first container side connection portion; 3b: second container side connection portion;
4 ... Partition stopper, 5 ... Sliding surface, 5a ... Sliding surface on the inner surface of the first container side connecting portion (3a), 5b ... Sliding surface on the inner surface of the second container side connecting portion (3b), 6 ... Communication passage , 6a ... first
6b: Second communication path, 7: Road end facing sliding surface (5), 8: Normally open road end facing container.

Continuation of front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61J 1/20 A61J 1/05

Claims (3)

(57) [Claims] 1. A container connecting part comprising a first container (1) sealingly containing a first medicine and a second container (2) sealingly containing a second medicine.
(3) is connected to communicate with the outside air in a shut-off manner,
(3) A partition plug (4) is disposed so as to be airtightly slidable, and the first container (1) and the second container (2) are slid by sliding the partition plug (4). In an aseptic holding and mixing device for two drugs housed in individually sealed containers, the communication is configured to be openable and closable,
The container connecting portion (3) includes a first container-side connecting portion (3a) and a second container-side connecting portion (3b).
3b) is connected via the partition plug (4), and a communication passage (6) is provided inside the partition plug (4),
The road end (7) of (6) is connected to the sliding surface (5) of the inner surface of the container connecting part (3).
, And the first container (1) and the second container (2) are pushed in a direction approaching each other, whereby the partition plug (4) hermetically slides on the sliding surface (5). Wherein the road end (7) facing the sliding surface (5) enters the container and is opened, wherein the aseptic holding and mixing device for the two drugs contained in the individually sealed containers is provided. . 2. The communication passage (6) provided in the partition plug (4),
One of the road ends (7) is opened facing the sliding surface (5) of the inner surface of the second container side connecting portion (3b) of the container connecting portion (3), and the other road end (8) is opened. 2. A container housed in an individually sealed container according to claim 1, wherein the container is always open facing the first container (1), and the first container-side connecting portion (3a) is airtightly fixed to the partition plug (4). Aseptic holding and mixing device for seed drugs. 3. A communication passage (6) provided in a partition plug (4) is provided with two communication passages (6).
Of the first communication path (6A), and one of the road ends (7) of the first communication path (6A) slides on the inner surface of the first container-side connecting portion (3a). 5a) and the other road end
(8) faces the inside of the second container (2) and is always open, and one of the road ends of the second communication path (6B) is connected to the second container-side connecting portion (3b). 2. The individually sealed container according to claim 1, wherein the container is opened so as to face the inner sliding surface (5 b), and is always open while the other road end (8) faces the first container (1). Aseptic holding and mixing device for two drugs.