JPH04329955A - Germ-free holding/mixing apparatus for two kinds of medicines held in individually sealed container - Google Patents

Abstract

PURPOSE:To achieve easy maintenance of germ-free state, communication between the inside of a soft container and that of a hard container simply by breaking a seal breaking part provided in a communication member, simple mixing of a medicine held therein with another medicine, very easy breakage of the seal breaking part, and moreover, a compact and simple construction of the apparatus as a whole while enabling simple separation of members after the administration of medicine without use of a metal communication needle as communication member. CONSTITUTION:A communication member 9 connected to a soft container 1 and a hard container 3 are formed tight-integrally. A communication hole 12 is cut near a side end 11 facing the inside of the hard container 3 from the side end 10 facing the inside of the soft container 1 of the communication member 9 and a seal breaking part 14 is provided at an inner hole end 13 of the communication hole 12. A seal breaking manipulation part 15 is delivered long from the seal breaking part 14 and the tip 16 thereof is stuck into the soft container 1.

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 types of drugs, each individually sealed, under aseptic conditions.

0002

[Background of the Invention] When administering drugs to patients through intravenous injection in medical institutions such as hospitals, drugs such as antibiotics are sealed in vials and dissolved in drugs such as physiological saline or glucose solution. . At this time, since these drugs tend to become unstable when mixed and dissolved and lose their efficacy in a relatively short period of time, the mixing operation of the drugs is performed immediately before administration.

[0003] Conventionally, this mixing operation is carried out in the following procedure using separately supplied drugs and syringes. ■
Unpack and prepare each package for both drugs and the syringe. ■ Open the liquid container, such as by breaking the ampoule, and inhale the dissolving drug in the liquid container into a syringe. ■
Penetrate the syringe needle into the rubber stopper of the vial and inject the drug for dissolution. ■ Shake the vial to dissolve the antibiotic within the vial. ■ Both dissolved drugs are drawn into a syringe and prepared for administration to the patient.

However, the above mixing operation has the following problems. stomach. An unwrapped syringe is exposed to the outside air and is easily contaminated with bacteria, and since the needle of the syringe is inserted into the container to transfer and mix the drugs, there is a risk that the mixed drugs may be contaminated with bacteria. B. Both drugs and the syringe, which are supplied separately, must be unpacked and prepared, and the surface of the rubber stopper through which the needle of the syringe is inserted must be sterilized, and the liquid drug must be inhaled into the syringe once. The mixing operation is extremely complicated. C. Because drugs contained in separate containers are mixed immediately before administration, complicated operations must be performed in a short time.
There is a possibility of mixing the mixed drugs incorrectly. D. Liquid drugs are often sealed in ampoule containers, and in this case, glass debris generated when the ampoule is broken tends to get mixed into the drug, and the drug comes into direct contact with the outside air, so there is a risk of contamination with bacteria. many.

[0005]

[Prior Art] Therefore, in order to solve these problems and to mix two types of drugs with a simple operation, JP-A-64-
A mixing device shown in Japanese Patent No. 85653 has been proposed.

[0006] As shown in FIG. 6, this mixing device has a first
A communicating needle (9) is fixed as a communicating member to a flexible container (1) made of a flexible material that contains a drug in a sealed manner, and a hard container (3) that contains a second drug in a sealed manner is attached to the tip of this communicating needle (9). It is placed facing you. Furthermore, the communication hole (12) formed in the communication needle (9) is sealed with a broken part (14) provided on the proximal side (10), and from this broken part (14) A seal-breaking operation part (15) is extended into the flexible container (1).

[0007] Then, the hard container (3) is converted into a flexible container (
1) and insert the tip (11) of the communicating needle (9).
) through the sealing stopper (4) of the hard container (3), break off the seal-breaking operation part (15) extending from the proximal side (10), and remove the seal-breaking part ( By breaking the seal of 14), the inside of the flexible container (1) and the inside of the hard container (3) are configured to communicate with each other.

[0008]

[Problems to be Solved by the Invention] However, in the above mixing device, the communication needle (9) that protrudes into the hard container (3)
) in a sterile state, the tip of the communicating needle (9) and the hard container (3) are connected to a cover part (3
In step 1), the device must be covered to block outside air, which increases the size of the device, and the space (34) inside the cover part (31) is wide, and this large internal space (34) must be kept in a sterile state. is not easy.

Furthermore, it is necessary to provide a guide cover (32) in this internal space (34) to prevent the communicating needle (9) from deviating from the container spout (4), resulting in a complicated structure.

Furthermore, the hard container (3) is moved relative to the small communicating needle (9) fixed to the flexible container (1), and the tip (11) of the communicating needle (9) is inserted into the sealing stopper (4). Since the communicating needle (9) only penetrates the sealing plug (4) and is not securely fixed, the breaking operation of the small seal-breaking operation part (15) must be done with sufficient force. There are problems in that it is difficult to add and the operation of breaking the seal is not easy.

On the other hand, the communicating needle (9) and the hard container (3) are housed in the flexible container (1) and a cover part (31) extending thereto. Container (3
) cannot be separated from the flexible container (1) and the cover part (31). As a result, the resource cannot be recycled, and the metal connecting needle (
9), the glass powder container (3), and the plastic member cannot be disposed of separately, which poses a major problem in terms of environmental pollution.

Furthermore, since the mixing device as a whole becomes larger, a large storage space is required, and since the hard container (3) is enclosed in the cover portion (31) extending from the flexible container (1), the mixing device It is not possible to stand the patient upright, and a large area is required for preparation of medication at a nursing center.

[0013] The present invention has been made with attention to these points, and it is easy to maintain a sterile state, the seal provided on the communication member can be easily broken, and the entire device is compact. To provide a sterility-maintaining and mixing device for two types of drugs housed in individual sealed containers, which has a simple structure, does not use a metal communication needle that is dangerous in terms of disposal, and allows each member to be easily separated after administration. The purpose is to

[0014]

[Means for Solving the Problems] In order to achieve the above object, the present invention includes forming the communicating member (9) and the hard container (3) into a hermetically integrated body. )
Of both ends (10, 11) of the flexible container (1)
The communication hole (12) is deeply recessed from the side end (10) facing inside to near the side end (11) facing inside the hard container (3), and the deep end of this communication hole (12) The communication hole (12) is sealed by a wall between the portion (13) and the side end (11) of the connecting member (9) facing into the hard container, and the hole is sealed in the wall. A sealing portion (14) is formed, and this sealing portion (
The container is characterized in that the seal-breaking operation part (15) extending from the flexible container (14) is passed through the communication hole (12) and then plunged into the flexible container (1).

[0015]

[Operation] Since the flexible container and the hard container are tightly connected and fixed via the communicating member, there is no wasted space between the two containers that requires sterilization. Furthermore, since the communication member provided with the seal-breaking portion and the seal-breaking operation portion is integrally formed with the hard container, it is possible to firmly hold the hard container and perform the seal-breaking operation. A seal-breaking part is provided at the back end of the deeply recessed communication hole, and the seal-breaking operation part is extended, so the arm length of the seal-breaking operation part is long, and the seal can be easily broken due to the boosting effect of the lever. The seal will be broken. In addition, the flexible container and the hard container communicate with each other by simply tearing the broken seal, and they are connected and fixed in a hermetically sealed state via the communication member, so the two types of drugs can be mixed while maintaining a sterile state. .

[0016]

Embodiments Hereinafter, embodiments of the present invention will be explained based on the drawings. 1 to 3 show Embodiment 1 of the present invention, FIG. 1 is a longitudinal sectional view of the mixing device, FIG. 2 is a longitudinal sectional view of the state in which the seal is broken, and FIG. 3 is the state in which the drip set is attached. FIG.

As shown in FIG. 1, this sterility-maintaining and mixing device has a container (1) made of a flexible material in which a solution such as physiological saline is hermetically stored, and the upper end of the flexible container (1) is sealed. A container connection part (2) is formed at the bottom, and a rubber stopper (28) is provided at the lower end for piercing an intravenous injection needle. The lower part of a communication member (9) made of synthetic resin is screwed and fixed to this container connection part (2) in a tight manner, and the lower end (10) of this communication member (9) is connected to the container. The inside of the flexible container (1) is exposed through the opening of the portion (2).

At the center of the upper part of the communication member (9), a hard container (3) made of glass is hermetically fixed to the mouth (4) of the container, and antibiotics etc. are contained in this hard container (3). A second drug is sealed and contained. Moreover, the container opening (4) of this hard container (3) is sealed with a rubber sealing plug (5).
The outer part of this sealing plug (5) is also embedded in and integrally fixed to the upper end part (11) of the communication member (9).

The lower end (10) of the communicating member (9) has a communicating hole (12) deeply recessed in the center toward the upper end (11), and the inner end (13) of the communicating hole (12) is deeply recessed in the center toward the upper end (11). ) is formed near the container opening (4) of the hard container (3). An annular breaking part (14) is provided at the inner end of the hole (13) around the buried part of the sealing plug (5).
) from the center downward to the cylindrical seal-breaking operation part (15)
is pulled out, and the tip (16) of the seal-breaking operation part (15) is thrust into the flexible container (1). Further, a space is formed between the seal-breaking operation part (15) and the circumferential surface of the communication hole (12) so that it can move laterally when the seal is broken.

Next, the procedure of the mixing operation will be explained. To break the seal, squeeze the hard container (3) and open the flexible container (3).
1) Apply force from the side to the tip (16) of the seal-breaking operation part (15). By this operation, the seal-breaking operation section (1
5) moves laterally around the inner end (13) of the communication hole (12) as the center of rotation, and a strong force is applied to the broken seal (14) due to the boosting action of the lever, as shown in Figure 2. As such, the tearing portion (14) is torn.

By the above operation, when the inside of the flexible container (1) and the inside of the hard container (3) are communicated through the communication hole, a part of the solution in the flexible container (1) is transferred into the hard container (3). The drug in the container is dissolved, and this solution is poured into the communication hole (1) again.
2) into the flexible container (1) to complete mixing of both drugs under aseptic conditions.

All of the mixed medicines are transferred into the flexible container (1), and as shown in FIG. The needle (27) on the side of the container is pierced and used for drip injection. This rubber stopper for dripping consists of a sealing lid (6) provided on the opposite side of the container opening (4) of the hard container (3) instead of being provided at the bottom of the flexible container (1), and is used throughout the mixing device. It may also be used for intravenous injection by inverting it upside down. In this case, the mixed medicine passes from the flexible container (1) through the communication hole (12) and the hard container (3) to the drip set (2).
6).

Note that when administering the mixed drug to a patient by inhaling it into a syringe, both containers (1 and 3
) is communicated, the solution is moved into the hard container (3) to dissolve the drug, which can then be inhaled into a syringe for use.

FIG. 4 shows a second embodiment, in which the container opening (4) of the rigid container (3) is directly sealed with a communicating member (9). With this configuration, the rubber plug for sealing the hard container (3) can be omitted, and the mixing device can be simplified. The other configurations are the same as in Example 1, and the seal-breaking operation section (15
) to the position shown by the imaginary line, the broken part (1
4) is broken, and the two types of drugs contained in the respective containers (1 and 3) are mixed under aseptic conditions as in Example 1.

The above-mentioned hard container (3) may be formed integrally with the communication member (9) by integrally molding it with a hard synthetic resin, as in Example 3 shown in FIG. In this case, the structure of the mixing device is further simplified, it can be constructed compactly, and it can be manufactured at low cost.

[0026]

[Effects of the Invention] Since the present invention is constructed and operates as described above, the following effects can be achieved. Since the flexible container and the rigid container are hermetically connected via the communication member,
There is no need for a guide cover for guiding the hard container toward the communicating member or a cover portion for covering the entire hard container, and the entire mixing device can be made compact and simple in structure. Furthermore, there is no space between the two containers that requires sterilization, and the space between the two containers can be maintained in a sterile state very easily.

[0027] Furthermore, since the inside of the flexible container and the inside of the hard container are communicated with each other simply by breaking the seal, the operation of mixing the two types of drugs is simple. Since the hard container can be firmly held down, it is possible to easily apply seal-breaking force to the tip of the seal-breaking operation part, and the long seal-breaking operation part is strong against the breaking part due to the leverage effect. Since force can be applied, the seal can be broken very easily.

Furthermore, since a metal communication needle is not used as a communication member, there is no danger even if it is disposed of as general waste, and each part can be easily separated and separated after administration.
Since it can be disassembled, glass and plastic parts can be separated and collected, preventing environmental pollution and effectively recycling resources.

[0029] Furthermore, since the mixing device is compact,
In addition to requiring less storage space, flexible containers can be easily stood upright, so when arranging a large number of containers in a nursing center or the like for preparation of medication after mixing, a large number of containers can be lined up in a limited preparation space.

[Brief explanation of drawings]

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

FIG. 2 is a longitudinal cross-sectional view of the unsealed portion of Example 1 in a state where the seal is broken.

FIG. 3 is a front view of the mixing device of Example 1 with the drip set attached.

FIG. 4 is a longitudinal cross-sectional view of the mixing device of Example 2.

5 is a diagram corresponding to FIG. 4 of Example 3. FIG.

FIG. 6 is a perspective view of a mixing device showing a conventional example.

[Explanation of symbols]

DESCRIPTION OF SYMBOLS 1... Soft container, 3... Hard container, 9... Communication member, 10... Side end facing flexible container (1), 11... Side end facing hard container (3), 12... Communication hole, 13... Hole depth End portion, 14... Seal breaking portion, 15... Seal breaking operation portion.

Claims (1)

[Claims] Claim 1: A flexible container (1
), a hard container (3) containing a second drug in a sealed manner, and a communication member (9) arranged between the flexible container (1) and the hard container (3) and connected and fixed to the flexible container (1). and the flexible container (1) from the seal breaking part (14) provided on this communication member (9).
and a seal-breaking operation part (15) extending inward, and by operating the seal-breaking operation part (15) through the flexible container (1) to break the seal-breaking part (14). , the flexible container (1) via the communication hole (12) provided in the communication member (9).
In a sterility-maintaining mixing device for two types of drugs housed in individual sealed containers, the communicating member (9) and the hard container (3) are hermetically integrated, and the inside of the hard container (3) is configured to communicate with the inside of the hard container (3). The both ends (
10 and 11), the side end (11) facing into the rigid container (3) from the side end (10) facing into the flexible container (1)
The communication hole (12) is deeply recessed near the hole, and the inner end (13) of the communication hole (12) and the connection member (9)
The communication hole (12) is sealed with a wall between the wall and the side end (11) facing into the hard container, and the broken portion (14) is formed in the wall, and the broken portion is sealed. The seal breaking operation part (15) connected from the seal part (14) is connected to the communication hole (12).
2 housed in an individually sealed container, characterized in that the flexible container (1) is made to pass through the flexible container (1) and then plunge into the flexible container (1).
A sterile mixing device for seed chemicals.