JP3475414B2 - Adapter for co-infusion - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a mixed injection adapter used for preparing a drug solution by injecting a solution into a vial containing a powder drug and mixing the powder drug and the solution.

[0002]

2. Description of the Related Art Conventionally, in a medical institution such as a hospital, a dried drug contained in a drug container such as a vial is dissolved in distilled water, a saline solution, a solution such as glucose solution (including other drug solution), and then drip. Used for injections, etc. In order to carry out such a dissolving operation, conventionally, a syringe with a needle or a device having a hollow puncture needle at both ends such as a double-ended needle has been used. That is, when using a syringe with a needle, first, a fixed amount of the solution is collected in the syringe, the needle is inserted into the rubber stopper at the mouth of the vial, and the solution is injected into the vial. Then, shake the vial to dissolve the drug, insert the needle into the rubber stopper again and collect a fixed amount of the drug solution in a syringe directly or transfer it to an infusion bottle containing glucose solution or saline. , Is administered intravenously using an infusion set. Also, when using a double-ended needle, puncture needles on both ends of the double-ended needle are inserted into the rubber stopper of the vial containing the drug and the rubber stopper of the solution container, respectively, to connect the two.
Transfer the solution to the vial to dissolve the drug, remove the solution container and double-ended needle from the vial, and collect a fixed amount of the drug solution from the vial into the syringe as described above, or directly remove the drug solution from the vial. The solution is transferred into the dissolution liquid container, the vial and the double-ended needle are removed from the dissolution liquid container, and intravenously administered via an infusion set connected to the dissolution liquid container.

In these conventional techniques, when a drug-dissolving operation is performed using a syringe with a needle, not only the operation is complicated, but also when the liquid is injected / collected, the liquid changes due to the fluctuation of the pressure in the vial. It is a problem because it may leak from the insertion part of the rubber stopper, and when using a double-ended needle, when applying to a drug that needs to collect a drug solution directly from the vial after the communication operation, It is uneconomical because it is necessary to prepare each equipment to be used. Therefore, in order to solve such a problem, there has been proposed a drug solution transfusing tool which does not leak a drug solution during the dissolution operation and can perform both operations of injecting and collecting the drug solution (Japanese Patent Publication No.
No. 24791).

The drug solution transfer device disclosed in Japanese Patent Publication No. 5-24791 is a syringe with a needle, and a drug contained in a small vial such as a protein preparation or a vitamin preparation which requires direct collection of the drug solution from the vial after the communication operation. It is convenient for dissolving. However, when the drug is a protein preparation such as albumin or globulin and the inside of the vial is maintained at a negative pressure, the syringe with a needle is used when the solution is injected or when the vial is shaken after injection of the solution. Bubbles are generated, and therefore, when collecting the drug solution, the bubbles may be inhaled together with the drug solution, and there is a drawback that an accurate liquid amount cannot be measured, which is a problem. Further, bubbles of the drug solution remain in the vial, which is uneconomical, which is a problem particularly in the case of expensive drugs.

[0005]

SUMMARY OF THE INVENTION The present invention has been made in view of the above circumstances, and an object thereof is to provide a mixed injection adapter which is easy to dissolve and does not leak a chemical solution during the dissolving operation. To do. It is another object of the present invention to provide a mixed injection adapter capable of eliminating bubbles during the dissolving operation of a protein preparation and eliminating bubbles generated in the vial during the dissolving operation.

[0006]

The present invention solves the problems of the complexity of the dissolving operation and the leakage of the drug solution that occurs during the dissolving operation, and is suitable for both ordinary syringes and prefilled syringes for dissolving solution.
A hollow puncture needle and a tubular tip mounting part are provided on opposite sides of the disk-shaped hub on the same axis.
And a cylindrical vial mounting portion that extends concentrically with the puncture needle beyond the tip of the puncture needle on the outer edge of the hub, and concentrically with the tip mounting portion beyond the tip of the tip mounting portion. The cylindrical syringe mounting part that extends to
An injection needle is provided on both ends of the tip mounting section, which is coaxially provided.
A communication means having a connecting portion and a puncture needle is detachably attached.
The hub puncture needle communicates with the tip mounting portion and is open to the cutting edge, and the chemical liquid passage is opened to the ventilation port with the sterilization filter provided in the vial mounting portion adjacent to the hub and the needle portion and have a gas passage opening to the cutting edge, the
The communication means is connected to the tip mounting part at the injection needle connecting part.
The mixed injection adapter that is installed is used. Further, the present invention adopts a constitution in which the vent hole is openably sealed by a closing member in order to solve the problems of the leak occurring during the dissolution operation of the protein preparation and the foam generated inside the vial during the dissolution operation. . In this case, the closing member used for the mixed injection adapter may be a cap or a film. Further, a check valve may be provided inside the ventilation port adjacent to the sterilization filter to prevent the fluid from moving toward the ventilation port.

[0007]

According to the above construction, the syringe filled with the solution is attached to the tip mounting part of the mixed injection adapter, and the puncture needle is pierced into the rubber stopper of the vial so that the syringe and the vial are communicated with each other. If the solution of (1) is injected, the powder formulation in the vial can be easily mixed with the solution by shaking the vial. In the case where the powder preparation is a foam such as a protein preparation which is produced by a dissolving operation, it is necessary to eliminate the generated foam. For that purpose, a structure in which the vent is hermetically sealed by a closing member may be adopted. In this case, after dissolving the protein preparation,
When the closing member is removed from the vent, the outside air flows from the vent through the gas passage into the vial, so that the inside of the vial becomes a negative pressure to a normal pressure. At this time, the bubbles of the drug solution generated in the vial are crushed and disappear by the increase of the internal pressure. Further, when inhaling the drug solution, similarly, the outside air flows in from the vent hole and the inside of the vial is always maintained at normal pressure, so that the drug solution does not leak from the insertion portion of the rubber stopper.

[0008]

Embodiments of the present invention will now be described with reference to the drawings. 1 to 3 are respectively a longitudinal sectional view, a plan view and a bottom view showing an embodiment of the mixed injection adapter of the present invention, and FIG. 4 is an embodiment in which a communicating means is attached to the mixed injection adapter shown in FIG. FIG. 5 and 6 are explanatory views showing a state where the mixed injection adapter shown in FIG. 1 is applied to a syringe, and an explanatory view showing a state where the mixed injection adapter shown in FIG. 4 is applied to a solution prefilled syringe, respectively. is there. As shown in FIGS. 1 to 3, the mixed injection adapter 1 of the present invention is provided with a hollow puncture needle 12 and a tubular tip mounting portion 13 on the coaxially opposite sides of a disk-shaped hub 11, respectively. Each of the outer edges of 11 has a cylindrical vial mounting portion 14 that extends concentrically with the tip of the puncture needle 12, and a cylindrical syringe mounting portion that extends concentrically with the tip of the tip mounting portion 13 and extends therefrom. A section 15 is provided. Then, the puncture needle 12 is opened to the drug solution passage 122 communicating with the tip mounting portion 13 and opening to the cutting edge 121, and to the ventilation port 16 with the sterilization filter 17 provided in the vial mounting portion 14 adjacent to the hub 11. Moreover, it has a gas passage 123 that opens to the blade edge 121 of the puncture needle 12.

The adapter 1 is entirely made of synthetic resin such as polypropylene, polyethylene, ABS resin, polycarbonate, polystyrene, etc., and is formed on the disk-shaped hub 11 and on the axially opposite side of the hub 11. The puncture needle 12 and the tip mounting portion 13, and the vial mounting portion 14 and the syringe mounting portion 15 which are concentrically formed with the puncture needle 12 and the tip mounting portion 13 on the outer edge of the hub 11, respectively. Chemical passage 1
22 and a gas passage 123, so that the chemical liquid passage 122 communicates with the tip mounting portion 13 and the gas passage 123 communicates with the ventilation port 16 with the sterilization filter 17 provided in the vial mounting portion 14 and opens. It has the basic configuration described above. Sterilization filter 17 provided inside the vent 16
When the outside air is introduced into the vial (not shown) through the puncture needle 12, the outside air is filtered to prevent bacteria from entering the vial.

The vent 16 is provided on the outer wall of the vial mounting portion 14 so as to project adjacent to the hub 11, and may be sealed with a closing member if necessary. The closing member can be freely opened from the vent hole 16, and bubbles generated when the drug in the vial is dissolved with the dissolution liquid can be eliminated by opening the bubble. As such an openable closing member, in addition to the cap 18 as shown in FIG. 1, a film (not shown) that is easily peeled off can be adopted. Any closing member that can open 16 can be used. It should be noted that the cap 18 may be provided with a tab (not shown) so that it can be easily removed from the vent hole 5, or a flexible connecting branch (not shown) connected to the adapter is provided. The removed cap 18 may not be lost.

A check valve 19 may be provided in the ventilation port 16 adjacent to and inside the sterilization filter 17 to prevent the fluid from moving toward the ventilation port 16. Particularly in the case of a highly viscous chemical solution, the chemical solution that has entered the gas passage 123 may adhere to the sterilization filter 17 and impair air permeation. However, the check valve 19 prevents the chemical solution from entering the sterilization filter 17. Adhesion can be prevented. Reference numeral 141 denotes a rib provided on the inner wall of the vial mounting portion 14 for facilitating the mounting of the vial, and the opening of the vial mounting portion 14 has a seal member 5 such as a film as shown in FIGS. 5 and 6. It may be sealed with to prevent contamination from the outside.

The adapter 1 has a syringe mounting portion 15 as shown in FIG. 4 formed slightly longer so that it can be applied to a solution prefilling syringe 4 as shown in FIG. You may make it the structure equipped with 2. The communication needle 2 is coaxially provided with an injection needle connection portion 21 and a puncture needle 2 at both ends.
It is a communicating means having 2, and the injection needle connecting portion 21 is attached to the tip attaching portion 13. The liquid passage 211 of the injection needle connection portion 21 and the liquid passage 221 of the puncture needle 22 are in communication with each other, and the hub 23 is opened on the puncture needle 22 side so that the mouth portion 41 of the dissolution liquid prefilling syringe 4 can be mounted. It is formed in a cup shape.

Next, the use of the adapter 1 of the present invention will be described. When the adapter 1 of the present invention is applied to a normal syringe, first, a syringe 3 filled with a solution (not shown) is prepared, and as shown in FIG. The chip 31 is mounted on the mounting part 15 and the chip 31 is mounted on the chip mounting part 13. Next, when a vial (not shown) containing a drug is mounted in the vial mounting portion 14 of the adapter 1, the rubber stopper at the mouth of the vial is pierced by the puncture needle 12, and the inside of the vial and the syringe 3 are inserted. The inside is communicated via the puncture needle 12 of the adapter 1. In this state, the plunger 32 of the syringe 3
When is pressed, the solution in the syringe 3 is injected into the vial through the drug solution passage 122. Therefore, the drug solution can be prepared by shaking the vial and mixing the drug and the solution.

On the other hand, when the adapter 1 of the present invention is applied to the solution prefilling syringe 4, first, a tip mounting portion 13 as shown in FIG. The dissolution liquid prefilling syringe 4 is attached to obtain the state shown in FIG. Next, when a vial (not shown) containing a drug is attached to the vial attaching portion 14 of the adapter 1, the rubber stopper at the mouth of the vial causes the puncture needle 1
Pierced by 2. Then, the pre-filled syringe for dissolving solution 4
When is pressed and attached to the hub 23 of the communication needle 2, the rubber stopper 42 of the solution prefilling syringe 4 is pierced by the puncture needle 22 of the communication needle 2, so that the inside of the vial and the solution prefilling syringe 4 are filled with the adapter 1 The puncture needle 12 and the communication needle 2 are communicated with each other. In this state, if the plunger 46 of the solution prefilling syringe 4 is pushed, the solution in the syringe 4 will be in the liquid passages 221 and 211 of the communication needle 2 and the drug solution passage 1 of the adapter 1.
Since it is injected through 22 into the vial, the vial can then be shaken to mix the drug with the solution to prepare the drug solution.

[0015]

As is apparent from the above description, by adopting the mixed injection adapter of the present invention,
Since the dissolution operation can be easily performed, the burden on the person performing the dissolution operation can be reduced. In addition, since there is no leak especially when dissolving the protein preparation,
The drug solution can be safely transferred. Further, bubbles generated in the vial during the dissolving operation can be easily erased, so that the drug solution can be accurately collected and the loss of the expensive drug solution due to the residual liquid can be prevented.

[Brief description of drawings]

FIG. 1 is a side sectional view of a mixed injection adapter of the present invention.

FIG. 2 is a plan view of the mixed injection adapter shown in FIG.

3 is a bottom view of the mixed injection adapter shown in FIG. 1. FIG.

FIG. 4 is a side sectional view showing a state where a communication needle is attached to the mixed injection adapter of the present invention.

FIG. 5 is a diagram showing a usage situation of the mixed injection adapter shown in FIG. 1.

FIG. 6 is a diagram showing a usage situation of the mixed injection adapter shown in FIG. 4.

[Explanation of symbols]

1 adapter 11 hubs 12 puncture needle 13 Chip mounting part 14 Vial mounting part 15 Syringe mounting part 16 vents 17 Sterilization filter 18 Cap (closing member) 19 Check valve 2 continuous needles 21 Injection needle connection part 22 Needle 3 syringes 4 Dissolution prefilled syringe

─────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-3-186271 (JP, A) JP-A-5-277156 (JP, A) JP-A 61-257654 (JP, A) Actual development Sho-63- 84239 (JP, U) (58) Fields surveyed (Int.Cl. ⁷ , DB name) A61J 1/20 A61J 3/00

Claims (5)

(57) [Claims] 1. A hollow puncture needle and a tubular tip mounting portion are provided on coaxially opposite sides of a disk-shaped hub, and a tip of the puncture needle is provided on an outer edge of the hub. A cylindrical vial mounting portion that extends concentrically with the puncture needle and a cylindrical syringe mounting portion that extends concentrically with the tip mounting portion beyond the tip of the tip mounting portion.
Insert the needle connection part and puncture both ends on the same axis on the tip mounting part.
A communication means having a needle is detachably attached,
The puncture needle of the hub is open to the drug solution passage communicating with the tip mounting part and opening to the cutting edge, the ventilation port with the sterilization filter provided in the vial mounting part adjacent to the hub, and to the cutting edge of the needle part. It has a gas passage, the communication means,
It is attached to the tip attachment part at the injection needle connection part.
A mixed injection adapter. 2. The mixed injection adapter according to claim 1, wherein the vent is hermetically sealed by a closing member. 3. The mixed injection adapter according to claim 2, wherein the closing member is a cap. 4. The mixed injection adapter according to claim 2, wherein the closing member is a film. 5. The mixed injection adapter according to any one of claims 2 to 4, wherein a check valve is provided inside the ventilation port adjacent to the sterilization filter to prevent the fluid from moving toward the ventilation port.