JPH04329956A - Germ-free holding/mixing apparatus for medicine held in individual sealed container - Google Patents

Abstract

PURPOSE:To achieve easy mixing of a powder drug and a liquid drug being kept free of germ, penetration of the tip of double-head needle for communication into a sealed plug of a powder agent container before that into a head of a liquid agent container, and further, to achieve a smaller size of the apparatus with a simple construction and easy maintenance of germ-free state while facilitating disassembling of parts. CONSTITUTION:A needle retaining case 5 is fastened airtight on a liquid agent container 1 and a support plug 13 fastened air-tight on a powder agent container 3 is fitted into a surrounding wall of the needle retaining case 5 internally in such a manner as to be slidable airtightly. A needle holder 7 is retained in the needle retaining case 5, and a double-head needle 9 is fixed on the needle holder 7 and both tips of the double-head needle 9 are opposed to a liquid agent sealed plug 2 and a powder agent sealed plug 4. At least one of the support plug 13 and the powder agent sealed plug 4 is provided with a release operating section 14. After the penetration of a powder agent container side end 11 of the double-head needle 9 into the powder agent sealed plug 4, the release operating section 14 presses the needle holder 7 to release the retention with the needle retaining case 5.

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 separately sealed powder medicine and liquid medicine under sterile 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 gets mixed into the drug, and there is a high risk of contamination with bacteria as the drug comes into direct contact with the outside air. .

[0005]

[Prior Art] Therefore, in order to solve these problems and to mix two types of drugs with a simple operation, we proposed the
A mixing device as shown in Japanese Patent No. 77 has been proposed.

As shown in FIG. 9, this mixing device includes a bag-like liquid container (1) containing a liquid drug, a glass powder container (3) containing a powder drug, and a needle locking case (1). 5
), a needle holder (7), and a double-ended needle (9), and the needle locking case (5) is airtightly fixed to the liquid container (1). (5), the sealing stopper (2) of the liquid container (1) and the sealing stopper (4) of the powder container (3) are made to face each other within the needle locking case (5).
) is provided with a locking receiving portion (6).

[0007] The needle holder (7) has a locking part (8) at the end.
) is inserted into the needle locking case (5) and removably locked in the locking receiver (6), and the double-ended needle (9) is inserted through the center of the needle holder (7). The double-ended needle (9) is configured such that one end (10) of the double-ended needle (9) faces the liquid sealing stopper (2) and the other end (11) faces the powder sealing stopper (4). be.

[0008] Then, the powder container (3) is replaced with the liquid container (1).
When pushing to the side, insert the double-ended needle (9) into the liquid container (1).
If one end (10) penetrates first, the liquid drug will flow into the needle locking case (5), so to prevent this, the powder sealing plug side end (11) should be penetrated first. A pressing portion (31) is integrally formed with the needle holder (7). That is,
This pressing part (31) holds the container mouth part (32) until the tip (11) of the double-ended needle (9) penetrates the powder sealing stopper (4).
) is configured to spread the pressing part (31) and press the locking part (8), and release the pressing when the pressing part (31) is fitted into the container neck (33).

Furthermore, in order to push the powder container (3) perpendicularly to the needle holder (7), a container guide portion (34) is extended to the needle locking case (5) to move the entire powder container (3). A pushing mechanism (35) is provided for pushing and operating the powder container (3) from the outside.

0010

However, the above mixing device has the following problems. 1. The container guide section (34) must cover the entire powder container (3) to isolate the inside from the outside air, as it is necessary to keep the part penetrated by the double-ended needle (9) in a sterile state, making the entire mixing device large. become

2. The entire powder container (3) is connected to the container guide part (
34), which is integrated with the needle locking case (5).
Therefore, the container guide part (
34) from the outside to insert the powder container (3) into the liquid container (
1) A pushing mechanism (35) is required to push the
The structure is complex.

3. The volume inside the container guide part (34) is large, and when incorporating a large number of members, it is difficult to maintain the entire interior in a sterile state.

4. The double-ended needle (9) and the powder container (3) are housed in the needle locking case (5) and the container guide part (34), and unless the container guide part (34) is destroyed after dispensing, there will be no movement in the mixing device. Double-ended needles and glass powder containers cannot be separated, making it impossible to recycle resources.
Since the metal double-ended needle, the glass powder container, and the plastic mixing device cannot be disposed of separately, there is an environmental pollution problem.

5. As the entire mixing device becomes larger, a large storage space is required, and a large container guide section and pushing mechanism are constructed on the top of the bag-like container, so it is difficult to stand the liquid container upright after mixing. This requires a large area for preparation of medication at nursing centers, etc.

The present invention was made in view of the above-mentioned problems, and is an apparatus that can easily mix powdered medicine and liquid medicine while maintaining sterility. , it is possible to pierce the sealing stopper of the powder container before the sealing stopper of the liquid container, and in addition, the entire device has a simple configuration and is miniaturized, and the powder container and double-ended needle can be easily separated after the mixing operation. It is an object of the present invention to provide a mixing device that maintains sterility of a drug contained in a sealed container.

[0016]

[Means for Solving the Problems] In order to achieve the above object, in the present invention, a support plug (13) is airtightly fixed to the powder container (3) so as to surround the powder sealing plug (4). The support stopper (13) is fitted and fixed to the powder container side end (5b) of the needle locking case (5) so as to be able to slide in an airtight manner, thereby sealing the liquid in the needle locking case (5). The space between the stopper (2) and the powder sealing stopper (4) is covered in an airtight and sterile state, and the support stopper (1)
A release operation part (14) is provided at the end of at least one of the powder sealing cap (4) and the liquid sealing cap (2), and when the powder container (3) is pushed toward the liquid container (1). To,
After the powder container side end (11) of the double-ended needle (9) passes through the powder sealing plug (4), the release operation part (14) abuts and presses the needle holder (7) and the needle Locking case (5
) and the needle holder (7) are disengaged from each other.

[0017]

[Operation] In the present invention, the support plug fixed to the powder container slides airtightly on the inner surface of the needle locking case fixed to the liquid container, so that the interior of the needle locking case is maintained in a sterile state. and,
The powder container can be pushed toward the liquid container by a simple manual push operation. At this time, the powder container and the support plug fixed thereto do not touch the needle holder until the powder container side end of the double-ended needle penetrates into the powder container, and the powder container and the support stopper fixed thereto do not touch the needle holder and are not locked with the needle locking case. It cannot be canceled.

Furthermore, since the support plug slides airtight within the needle locking case, it can be easily removed from the needle locking case after the mixing operation, and the powder container and double-ended needle can be easily separated.

In addition, the mixing device is compact and requires less storage space, and the liquid container can be corrected not only when the needle locking case and powder container are removed from the liquid container, but also when preparing to administer medication with the needle retaining case and powder container attached. It can be left standing.

[0020]

Embodiments Hereinafter, embodiments of the present invention will be explained based on the drawings. 1 to 4 show a first embodiment of the present invention, and FIG.
a) is a vertical sectional view of the mixing device of the first embodiment, FIG. 1(b) is an enlarged view of part b of FIG. 1(a), FIG. 2 is a sectional view showing the operation sequence of the mixing operation, and FIG. FIG. 4 is a perspective view with each part disassembled later, and a cross-sectional view of the drip set attached to the liquid container.

[0021] As shown in Fig. 1, this sterility-maintaining mixing device has a liquid container (1) containing a liquid drug hermetically sealed therein and a powder container (3) containing a powdered drug hermetically sealed with each other.
2 and 4) are placed facing each other. A cylindrical needle locking case (5) is placed around the liquid sealing plug (2).
One end (5a) of the container is screwed together and fixed to the liquid container (1) in an airtight manner. Further, on the inner surface of the peripheral wall of the needle locking case (5), a locking receiving portion (6) is formed by recessing an annular groove approximately in the center.

On the other hand, the powder sealing stopper (4) of the powder container (3)
An annular support plug (13) is fixedly fixed in an airtight manner,
This support plug (13) is connected to the other end (
5b) It is fitted inside the inner surface of the side peripheral wall in an airtight and slidable manner. As a result, the space between the liquid sealing plug (2) and the powder sealing plug (4) in the locking case (5) is formed in a state of being shut off from outside air, and a sterile state is maintained.

[0023] In the figure, reference numeral (16) indicates a fixture that prevents the powder container from being accidentally moved during transportation or storage of this mixing device, and is removed prior to the drug mixing operation. It is. Note that this fixture (16) only needs to prevent the powder container (3) from moving;
It can be constructed by a spacer that engages the neck of the neck or by other suitable means.

A disk-shaped needle holder (7) is disposed within the needle locking case (5), and a locking portion (8) is provided at the peripheral edge of the needle holder (7). The above locking receiving part (6)
It is removably locked to. And this needle holder (7
A double-ended needle (9) is passed through and fixed in the center of the double-ended needle (9), with one end (10) of the double-ended needle (9) facing the liquid sealing stopper (2), and the other end ( 11) is placed facing the powder sealing stopper (4).

[0025] Also, the liquid sealing stopper (2) of the powder sealing stopper (4)
) An annular release operation portion (14) is provided protruding from the near end. Note that this release operation part (14) is connected to the powder container (
3) toward the liquid container (1), the needle holder (7)
), it may be configured by the entire end surface of the powder sealing plug (4), or by contacting the liquid sealing plug (2) of the support plug (13).
) It may also be formed on the closer end surface.

Next, the procedure of the mixing operation will be explained. After removing the above fixture (16), remove the powder container (3)
When the support stopper (13) airtightly slides on the inner surface of the circumferential wall of the locking case (5) and moves toward the liquid container (1), the support stopper (13) airtightly slides on the inner surface of the peripheral wall of the locking case (5). At this time, the sealing plug (4) and support plug (13) of the powder container (3) are connected to the needle holder (7).
), but only the tip (11) of the double-ended needle (9), so the needle holder (7) does not touch the needle locking case (5).
) is securely locked.

When the powder container (3) is further pushed forward, as shown in the left half of FIG. container(
3) and the communication path (
After one end of 12) is opened in the powder container (3), the above-mentioned release operation part (14) comes into contact with the needle holder (7).

Then, when the powder container (3) is pushed further, the release operation part (14) presses the needle holder (7) and the locking part (8) engages the locking receiving part of the needle locking case (5). (6)
deviate from After this, the double-ended needle (9) moves to the liquid container (1) side together with the powder container (3) via the needle holder (7), and as shown in the right half of FIG. Tip of liquid container side (
10) penetrates through the liquid sealing plug (2) and connects to the communication path (1).
2) the other end opens in the liquid container (1) and the powder container (3)
) and the inside of the liquid container (1) communicate with each other.

When the insides of both containers (1 and 3) are communicated, a part of the liquid drug is moved into the powder container (3) to dissolve the powder drug, and this solution is transferred again to the communication path in the double-ended needle (9). (12)
and into the liquid container (1) to complete the mixing of both drugs under aseptic conditions.

After mixing both drugs, the needle locking case (
5) is removed from the liquid container (1) and prepared for administration,
At this time, in order to pull out the double-ended needle (9) from the liquid sealing stopper (2) at the same time, there is a protrusion (
19) is provided. As shown in FIG. 3, the powder container (3) and the double-ended needle (9) are further separated and recovered from the needle locking case (5).

When performing an intravenous injection, as shown in FIG. 4, the container-side needle (27) of the intravenous drip set (26) is inserted into the liquid sealing stopper (2) of the liquid container (1) containing the mixed drug. Use by piercing. When administering the mixed drug to a patient by inhaling it into a syringe, use the double-ended needle (9) to insert both containers (1
- After 3) is communicated, the liquid medicine is moved into the powder container (3) to dissolve the powder medicine, which can then be inhaled into a syringe and used.

FIGS. 5 to 7 show a second embodiment of the present invention,
The end surface of the support stopper (13) closer to the liquid container (1) constitutes a release operation section (14), and as shown in FIGS. 5 and 6, the engagement provided at the end of the needle holder (7) A lock release portion (15) extends from the stop portion (8) to between the needle holder (7) and the release operation portion (14). In addition, the code (17) is a spacer for fixing the powder container, and the packaging (17) is a spacer for fixing the powder container.
8), the spacer (17) is removed from the neck of the powder container (3) and a mixing operation is performed.

The rest of the structure is the same as that of the first embodiment, and as shown in FIG. 7, when the powder container (3) is pushed toward the liquid container (1), the tip of the double-ended needle (9) ( 11
) passes through the powder sealing plug (4), and one end of the communicating path (12) opens into the powder container (3). Then, support plug (1
The above-mentioned release operation part (14) of 3) contacts and presses the lock release part (15) extending from the lock part (8), and the lock release part (15) releases the needle holder (7). ), and the locking part (8) is removed from the locking receiving part (6). After this, the same operations as in the first embodiment described above are performed to complete the sterile mixing of both drugs.

In each of the above embodiments, the needle on the container side of the drip set is inserted into the sealing stopper for the liquid, but as shown in the modification shown in FIG. It may also be provided at the bottom of the container (1). In this case, the needle locking case (5) can be used with the needle locking case (5) attached to the top of the liquid container (1).
It can also be formed integrally with 1). Furthermore, in this case, it is desirable to provide legs (29) at the bottom of the liquid container (1) to make it easier to stand the liquid container upright.

[0035]

[Effects of the Invention] Since the present invention is constructed and operates as described above, the following effects can be achieved. After one end of the double-ended needle penetrates into the powder container, the locking release operation part comes into contact and releases the locking of the needle holder from the needle locking case, so the double-ended needle does not move into the liquid container. The powder can be reliably penetrated into the powder container prior to piercing, and as a result, the liquid drug does not leak into the needle locking case. Moreover, since the powder container can be directly held and operated, the container can be rotated and pushed forward, for example, and the tip of the double-ended needle can be easily penetrated into the sealing stopper.

Since the inside of the needle locking case fixed to the liquid drug container is maintained in a sterile state by a support plug that slides airtight on the inner surface of the peripheral wall, there is no need for a storage cover to cover the entire powder container in a sterile state. It requires an extremely compact configuration. Moreover, since the space in the needle locking case to be kept in a sterile state is small and the number of parts to be assembled is small, the inside of the needle locking case can be maintained in a sterile state extremely easily. Since there is no structure that covers the entire powder container, the powder container can be pushed directly in the hand, and there is no need for a mechanism to indirectly operate the powder container from a remote location, making the structure simple and inexpensive. Can be implemented.

[0037] Since the mixing device is compact, it requires less storage space, and the liquid container can be easily stood upright, so when arranging the containers at a nurse center etc. for preparation of medication after mixing, it takes up limited preparation space. You can line up many.

After the mixing operation, the needle locking case can be removed from the liquid container and the powder container and double-ended needle can be easily separated and recovered, so that the environment is not contaminated with waste and resources can be effectively recycled. .

[Brief explanation of the drawing]

1 shows a first embodiment of the present invention, FIG. 1(a) is a longitudinal sectional view of a mixing device, and FIG. 1(b) is an enlarged view of part b of FIG. 1(a).

FIG. 2 shows the operating sequence of the mixing operation in the first embodiment of the present invention, the left half diagram is a vertical cross-sectional view of the main part with the tip of the double-ended needle penetrating the powder sealing stopper, and the right half diagram is a longitudinal sectional view of the main part with the tip of the double-headed needle penetrating the powder sealing stopper. FIG. 6 is a longitudinal cross-sectional view of the main part in a state where both tips have penetrated the powder sealing plug and the liquid sealing plug.

FIG. 3 is a perspective view of the needle locking case, needle holder, and powder container separated from the liquid container at the end of the mixing operation according to the first embodiment of the present invention;

FIG. 4: In the liquid container after the mixing operation of the first embodiment of the present invention,
It is a sectional view of a state where an infusion set is attached.

5 shows a second embodiment of the present invention, FIG. 5(a) is a longitudinal sectional view of a mixing device, and FIG. 5(b) is an enlarged view of part b of FIG. 5(a).

FIG. 6 is a perspective view of a needle holder to which a double-ended needle is fixed according to a second embodiment of the present invention.

FIG. 7 is a diagram corresponding to FIG. 2 showing the operating sequence of the mixing operation in the second embodiment of the present invention.

FIG. 8 is a sectional view of a main part of a liquid container in which a rubber stopper for dripping is provided at the bottom of the liquid container, showing a modification of the embodiment of the present invention.

FIG. 9 is a vertical cross-sectional view of a mixing device showing a conventional example.

[Explanation of symbols]

1...Liquid container, 2...Liquid sealing stopper, 3...Powder container, 4...Powder sealing stopper, 5...Needle locking case, 5b...Powder container side end of needle locking case, 6...Lock receiving portion, 7 ...needle holder, 8
... Locking portion, 9... Double-ended needle, 10... End of double-ended needle on the liquid sealing plug side, 11... End of the double-ended needle on the side of powder sealing plug, 13... Support stopper,
14...Release operation section, 15...Latch release section.

Claims (2)

[Claims] Claim 1: A liquid drug container (1) containing a liquid drug, a powder container (3) containing a powder drug, a needle locking case (5), a needle holder (7), and a double-ended needle (9). and
The needle locking case (5) is fixed to the liquid container (1) in an airtight manner, and the sealing stopper (2) of the liquid container (1) and the powder container are connected to each other in the needle locking case (5). (3) Sealing stopper (
4) and this needle locking case (5)
A locking receiving part (6) is provided on the inner surface of the peripheral wall of the needle holder (
7) is provided with a locking part (8) at the end, and the needle locking case (
5) and removably locks into the locking receiving part (6),
The double-ended needle (9) is passed through and fixed in the center of the needle holder (7), with one end (10) of the double-ended needle (9) facing the liquid sealing stopper (2), and the other end Part (11
) facing the powder sealing stopper (4), in a sterile mixing device for maintaining and mixing drugs housed in individual sealed containers, the support stopper (13) is placed in a state surrounding the powder sealing stopper (4), and the support stopper (13) is attached to the powder container. (3) in an airtight manner, and this support plug (13
) to the powder container side end (5b) of the needle locking case (5).
The support plug (13) is fitted and fixed in an airtight and slidable manner to cover the space between the liquid sealing stopper (2) and the powder sealing stopper (4) in the needle locking case (5) in an airtight and sterile state. ) and powder sealing stopper (
A release operation part (14) is provided on at least one side of the liquid sealing stopper (2) with respect to the liquid sealing stopper (2), and when the powder container (3) is pushed toward the liquid container (1), the double-ended needle (9) After the powder container side end (11) passes through the powder sealing plug (4), the release operation section (14) abuts and presses the needle holder (7) to close the needle locking case (5). A sterile mixing device for maintaining and mixing drugs contained in individual sealed containers, characterized in that the device is configured to release the lock between the needle holder (7) and the needle holder (7). 2. Connect the lock release part (15) from the lock part (8) of the needle holder (7) to the needle holder (7) and the release operation part (
When the powder container (3) is pushed toward the liquid container (1), the end (11) of the double-ended needle (9) on the powder container side touches the powder sealing plug (4). ), the release operation part (14) passes through the lock release part (15).
2. The sterile mixing device for maintaining and mixing drugs contained in individual sealed containers according to claim 1, wherein the locking case (5) and the needle holder (7) are unlocked by pressing the locking case (5) against the needle holder (7).