JP3066611B2 - 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 formed by a central stopper box (3). A partitioning stopper (4) is slidably fitted in the stopper box (3) to seal the communication between the first container chamber (1) and the second container chamber (2). is there. A pressing mechanism (31) is provided in the upper part of the second container chamber (2) so as to shut off the outside air. As shown in the right half of FIG. 6, the pressing mechanism (31) is connected to the second container chamber (2). A partition plug (4) which is airtightly slid on the inner surface and attached to the lower end of the pressing part (32)
Is pushed into the first container chamber (1) side, and the above-mentioned sealing is released to mix the two kinds of medicines.

[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 remote control from the outside of the container. ), It is necessary to provide a complicated pressing mechanism (31).

In addition, since the pressing mechanism (31) needs to hold both drugs under aseptic conditions, they must slide in an airtight manner with respect to the second container chamber (2). (4)
The problem is that the sliding resistance increases when combined with the sliding resistance of the sliding surface (5) in the stopper box (3), and a strong operating force is required to connect the two container chambers (1.2). was there.

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. It is another object of the present invention to provide an aseptic holding and mixing apparatus for two drugs contained in individually sealed containers, in which the entire apparatus has a compact and simple structure.

[0011]

The present invention achieves the above objects.
To achieve this, for example, from FIG.
Explaining with reference to FIG.
The aseptic holding and mixing device for seed drugs is configured as follows
is there. That is, the present invention provides a first container in which a first medicine is hermetically contained.
A stopper box containing (1) and a second container (2) which contains and seals a second drug.
(3) is connected to communicate with the outside air in a shut-off manner.
Then, the first container (1) is sealed with the first container-side plug (4a).
At the same time, the second container (2) is sealed with the second container-side plug (4b).
Then, the communication between the first container (1) and the second container (2) is cut off.
The first container side plug (4a) and the second container
The side plug (4b) and the side plug (4b) are connected and fixed
A stopper (4) is formed, and the partition stopper (4) is placed in the stopper box.
(3) Closed position by rotating and sliding airtight inside
Constitute the switching 換可 ability to (A) and unplugging position (B), and to butt set the plug turning lever from the partition plug among the (4) (6) to the plug box (3) External <br/> Rutotomoni, the communicating passage (7) in the intermediate partition Ri plug (4) is provided,
When the partitioning stopper (4) is switched to the closing position (A) by the stopper rotating lever (6), the road end opening (8) of the communication passage (7) slides with the stopper box. The communication between the first container (1) and the second container (2) is cut off facing the surface (5), and the partition plug (3) is moved to the open position ( B)
When the switching operation is performed, the sliding surface of the communication path (7) is
The blockage by (5) is released so that the first container (1) and the second container (2) communicate with each other through the communication passage (7).

[0012]

The first container-side plug and the second container forming the partition plug are provided.
The container-side stopper seals the first container and the second container respectively.
And only by connecting and fixing each other with connecting means,
The first container and the second container connected via the box are as follows.
Before the communication operation, each is sealed by each stopper.
I have. And the communication operation is done with a simple structure of the plug rotation lever .
This operation is performed by directly rotating and sliding the partition stopper to switch between the closing position and the opening position . At this time, since the stopper turning lever protrudes from the partition stopper to the outside of the stopper box, a strong rotation force is applied to the stopper by the operating force applied to the tip of the longer stopper rotating lever by the leverage boosting action. Occurs. The middle partition stopper hermetically slide operation of the stopper rotating lever
It is switched in stoppered position or RaHiraku stopper position Te by this in the first container via a communication passage provided in the partition stopper and the second container are communicated with each other.

[0013]

Embodiments of the present invention will be described below with reference to the drawings. 1 to 5 show an embodiment of the present invention, FIG. 1 is a longitudinal sectional view of a mixing device, FIG. 2 is a perspective view of a partition plug, FIG. 3 is a sectional view taken along line III-III of FIG. 1, and FIG. FIG. 5 is a longitudinal sectional view showing a state in which the middle partition stopper is switched to the open position, and 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 is provided above the first container (1). Container opening
The lower part of the stopper box (3) is airtightly fixed to (11). This tap box
(3) is a second container (2) containing a second drug such as an antibiotic.
Extending downwardly from the lower part of the
The inside of the container (1) and the inside of the second container (2) are communicatively connected via a stopper box (3).

In this embodiment, the stopper box (3) is connected to the second container.
Although extended to (2), it may be formed separately and the stopper box (3) may be hermetically fixed to the lower part of the second container (2). A rubber stopper (28) is provided at the lower part of the first container (1) for penetrating the container side needle of the drip set, and the upper part of the second container (2) is sealed with a sealing lid (10). It has stopped.

A partition plug (4) is rotatably slidably fitted in the stopper box (3), and one side of the stopper box (3) is provided with the partition stopper (4). On the sliding surface (5), a long groove (1
2) is formed, and an opening (13) is formed in the peripheral wall on the other side.

The inner partition plug (4) includes a first container side plug (4a) for sealing the first container (1) and a second container side plug (4b) for sealing the second container (2). ) And are integrated by a connecting pin (16). With this configuration, the first
The first container (1) containing the medicine is plugged with the first container side plug (4a),
The second container (2) containing the second drug is inserted into the second container-side plug.
In (4b), can each be tightly sealed individually. As a result, the second container (2) is placed in the first container while maintaining the aseptic condition.
It can be easily assembled to (1) via the stopper box (3) .

As shown in FIG. 2, the partition plug (4) communicates from the center of the lower end (14) and the center of the upper end (15) to one side of the peripheral side. And a stopper rotating lever (6) is attached to the other side on the peripheral side.

The stopper rotating lever (6) is connected to the opening (13).
Through the stopper box (3). As shown in FIG. 3, the opening (13) has a long opening in the circumferential direction, and the stopper turning lever (6) is turned counterclockwise in plan view to open the partitioning stopper ( In the plugging state in which 4) is operated to the plugging position (A), the sliding surface (5) is located at a position where the peripheral road end (8.8) of the communication path (7.7) is out of the groove (12). It is open to face. Therefore, in this closed state, the communication path (7
The peripheral road end (8, 8) of (7) is closed by the sliding surface (5) with the stopper box (3), and the inside of the first container (1) and the inside of the second container (2) are Communication is blocked.

Next, the procedure of the mixing operation will be described.
The communication operation between the inside of the first container (1) and the inside of the second container (2) is performed by rotating the stopper rotating lever (6) clockwise in plan view to open the partition stopper (4) at the opening position. This is done by moving to (B).

By this operation, the partition stopper (4) is moved to the stopper box.
(3) The sliding surface inside is rotated and slid, and as shown in FIG.
The peripheral side road end (8.8) of the communication passage (7.7) is the groove portion (12).
And the inside of the first container (1) and the inside of the second container (2) communicate with each other via the communication passage (7.7). In the present embodiment, a vertically long groove (12) is formed on the sliding surface (5) of the stopper box (3), but this groove (12) can be connected to the communication path (7, 7). It can be formed into an appropriate shape such as a recess.

By the above operation, the inside of the first container (1) and the second container
When the inside of the container (2) communicates, the solution in the first container (1) is partially moved into the second container (2) to dissolve the second drug in the container, and this solution is again passed through the communication path ( 7) Through the first container
(1) Move inside and complete the mixing of both drugs under aseptic conditions.

All the mixed medicines are transferred into the first container (1), and as shown in FIG. 5, a drip set (26) is placed in a rubber stopper (28) provided at the lower part of the first container (1). The container side needle (27) is pierced and used for instillation. Instead of providing the rubber stopper for drip at the lower part of the first container (1), a sealing lid (10) at the upper end of the second container (2) may be used. The medicine is turned upside down and the mixed medicine is sent from the first container (1) to the infusion set (26) through the communication path (7) 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 (7).
(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.

[0025]

According to the present invention, the following effects can be obtained from the configuration and operation described above. Since the partitioning stopper in the stopper box is directly rotated by the stopper rotating lever having an extremely simple structure, a complicated pressing mechanism for moving the partitioning stopper is not required, and the entire mixing apparatus is compact. It can have a simple structure and can be implemented at low cost.

In addition, since there is only one part which can be airtightly slid by the switching operation of the partition stopper, the sliding resistance is small and
The operating force applied to the tip of the stopper rotating lever generates a strong turning force on the partition stopper due to the boosting action of the lever, so that the partition stopper can be rotated lightly, and it is extremely easy to open and The inside of a container can be connected.

In addition, the communication between the inside of the first container and the inside of the second container requires only a simple operation of rotating the stopper rotating lever, and this operation moves the partitioning stopper from the closed position to the open position. Because of the airtight sliding, the two types of drugs can be mixed while maintaining the aseptic condition.

Further, since the first container and the second container are formed separately, it is possible to use drug containers suitable for the respective properties of the two kinds of stored drugs. Therefore, for example, when one drug is liable to be deteriorated due to moisture absorption, only the container containing this drug may be formed in a moisture-proof container, and the other drug container may be a general plastic bottle or the like. Cost can be reduced.
Furthermore, even if the drug supplier is different, each drug is stored in a separate container, so that it is easy to maintain sterility during assembly.
It can be easily assembled while this assembly
After connecting the two containers to each other via the stopper box,
Before performing the communication operation, plug each container into the first container side plug.
Can be sealed individually with the body and the second container side plug
You.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a mixing apparatus, showing an embodiment of the present invention.

FIG. 2 is a perspective view of a partition plug of the embodiment.

FIG. 3 is a sectional view taken along line III-III of FIG. 1;

FIG. 4 is a longitudinal sectional view showing a state where the partition plug is switched to an open position in the embodiment.

FIG. 5 is a front view showing a state where an infusion set is attached to the mixing apparatus of the embodiment.

FIG. 6 is a longitudinal sectional view of a mixing apparatus showing a conventional example, in which the left half shows a state before the mixing operation, and the right half shows a state after the mixing operation.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1 ... 1st container, 2 ... 2nd container, 3 ... Stopper box, 4 ... Partition stopper, 5 ... Sliding surface, 6 ... Stopper turning lever, 7 ...
Communication passage, 8: Road end, A: Close position, B: Open position.

──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. ⁷ , DB name) A61J 1/20 A61J 3/00 312 A61J 1/05

Claims (1)

(57) [Claims] 1. A first container (1) in which a first medicine is hermetically stored and a second container (2) in which a second medicine is hermetically sealed are connected to each other via a stopper box (3) so as to shut off the outside air. In the stopper box (3), the first container (1) is connected to the first container-side stopper.
(4a) and seal the second container (2) with the second container
Sealed with a stopper (4b), the first container (1) and the second container (2)
And the first container-side plug (4a) is connected to the second container-side plug (4b).
Forming the partition plug (4) by connecting and fixing each other by means (16)
And, rotating the partition plug therein (4), in an airtight manner within the plug box (3)
Configured to <br/> switching 換可 ability to plugging position (A) and unplugging position and (B) by sliding the plug rotation lever (6) the plug box from the inside partition plug (4) ( 3) impact setting to Rutotomoni outside, the communication passage in the intermediate partition Ri plug (4)
(7) is provided, and when the partitioning stopper (4) is switched to the closing position (A) by the stopper rotating lever (6), the road end opening (8) of the communication passage (7) is closed. The communication between the first container (1) and the second container (2) is cut off by facing the sliding surface (5) with the stopper box, and the partition plug (3) is turned on the stopper rotating lever (6). In the state where the operation is switched to the opening position (B), the blockage of the communication path (7) by the sliding surface (5) is released, and the first container (1) and the second container (2) are disconnected. Are configured to communicate with each other via the communication path (7), wherein the two kinds of medicines are aseptically retained and mixed in individually sealed containers.