JPH0433224B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to an infusion container, and more particularly to an infusion container in which a powdered drug or the like contained in a container such as a vial can be dissolved aseptically immediately before use.

<Prior art> In hospitals and other medical institutions, powdered or freeze-dried drugs in containers such as vials have been dissolved and used as infusions for intravenous drip therapy. This is done by connecting a container containing a drug and a container containing a solution for dissolving the drug using a connecting tool such as a double-ended needle or a connecting tube, and transferring the solution to the container containing the drug. However, this operation is complicated and time-consuming, and since the hole for connecting to the container containing the drug is performed in the open air, there is a risk that the drug inside may be contaminated.

Therefore, in order to solve the above-mentioned problems, an infusion container as shown in Japanese Patent Publication No. 1983-501129 has been proposed.

As shown in FIG. 11, this infusion container includes a capsule 3 containing a vial 301 containing a drug.
02 and a flexible container 303 containing a solution having a drug solution outlet are connected by a tube 304. Inside the tube 304, a hollow puncture needle 305 is attached to the drug vial 301 side, and a breaking member 306 is attached to the flexible container 303 side. This breaking member 306 closes the passage within the tube 304 and prevents fluid flow.

In use, press the cap 307 at the top of the capsule 302 with your finger to push down the vial 301, and insert the rubber stopper 30 of the vial 301 with the puncture needle 305.
8 to first connect the flexible container 303 and the vial 301. Then, the breakable member 306 in the tube 304 is manually broken to open a passage in the tube 304 and mix the drug and the solution.

<Problems to be Solved by the Invention> However, although the infusion container has been improved in that the drug container and the solution container are communicated with each other for mixing, the puncture needle 305 does not allow the vial to be 301 rubber stopper 308
After piercing the hole, the breaking member 306 must be broken by hand to open the passage, which still requires considerable effort. In addition, if the breakable member 306 is imperfectly bent, there is a disadvantage that it is difficult for the liquid to pass through and it takes time to dissolve. Furthermore, the breaking member 306
There is also the drawback that the broken pieces of the phlegm are left in the flexible container 303, causing unnecessary mental anxiety to the patient undergoing infusion therapy.

The present invention was made in view of such circumstances,
To provide an infusion container that enables reliable and easy communication between a drug container and a container for a dissolution solution or dilution solution (hereinafter referred to as dissolution solution), and allows mixing of the drug and the solution in a short time after communication. purpose.

<Means for Solving the Problems> In order to solve the above-mentioned problems, the present invention provides a thermoplastic resin bag for accommodating a drug container, and a needle with a hollow opening that is housed in the bag in an inverted state. A drug container sealed with a stopper that can be pierced by a hollow needle, a communication part whose liquid passage is closed by a closure membrane that can be penetrated by a hollow needle, and a drug solution outlet on the opposite side of the communication part. a dissolving solution container containing a dissolving solution or a diluting solution therein, and a dissolving solution container that is communicatively connected to the bag body;
a flexible cylindrical body connected to the communication portion of the solution container; a flexible cylindrical body housed in the bag body and at least a portion of which is inserted into the cylindrical body so as to be movable only in the axial direction; and a communication means consisting only of a hollow needle or having a hollow needle provided therein, which is located between the drug container and the solution container and communicates the insides of the two containers, and the drug container and the solution container are placed at a predetermined interval. An infusion container is used that enables aseptic dissolution or dilution of drugs, and includes a removable container support means fitted to the outside of a cylindrical body that communicates and connects both containers for support and fixation.

<Function> According to the above configuration, in use, by removing the container support means from the infusion container, the medicine container and the solution container can become close to each other. Therefore, grasp the hollow needle, which is the communication means with the drug container, with your hand, first lower the drug container and pierce one cutting edge of the hollow needle through the stopper of the drug container, and then use the hand that was holding the hollow needle to hold the solution solution container. If the other cutting edge of the hollow needle is inserted into the communicating part of the solution container by grasping the drug container and further lowering the drug container, the drug container and solution container will communicate with each other through the communication means, so that the solution container can be removed from the solution container. By introducing a dissolving liquid into the drug container, the drug in the drug container can be easily and aseptically dissolved.

<Example> Next, an example of the present invention will be described based on the drawings.

FIG. 1 is a sectional view of essential parts of an infusion container according to an embodiment of the present invention, FIG. 2 is a front view of an embodiment of the container support means, and FIG. 3 is a sectional view taken along the line A-A in FIG. 2. , FIGS. 4 and 7 are sectional views and perspective views showing other embodiments of the container support means, and FIGS. 5 and 6 are sectional views taken along line B-B of the container support means shown in FIG. It is a sectional view taken along the line CC. 8 is a sectional view showing an embodiment of the communication means, FIG. 9 is an explanatory diagram showing an embodiment of the solution container, and FIG. 10 is an explanatory diagram showing another embodiment of the solution container.

As shown in FIG. 1, the infusion container of the present invention includes a thermoplastic resin bag 1, a drug container 2 housed in the bag 1, a solution container 3 containing a solution, and the bag 1. A cylindrical body 4 that is interposed between the solution container 3 and connects the two, a communication means 5 that communicates the drug container 2 and the solution container 3, and a drug container 2 and the solution container 3.
It consists of removable container support means 6 that supports the container at a predetermined interval.

Each part will be explained in detail below.

The bag body 1 is made of thermoplastic resin such as polyethylene, polypropylene, soft vinyl chloride resin, ethylene vinyl acetate, etc., and is used to cover and protect the drug container 2 housed therein in a sterile manner. It is. A hanger hole 7 serving as a suspension means is provided at the end of the bag 1, the end opposite to the solution container 3. Other suspension means such as hooks and strings can also be used. Although the bag 1 is not necessarily required in the case of a film made of a film such as polypropylene or polyester that does not easily adhere to the glass drug container 2, it is generally necessary to prevent the bag from adhering to the drug container 2. Therefore, it is necessary to make the inner surface rough or to form fine longitudinal ridges on the inner surface.

The drug container 2 is stored in an inverted state within the bag body 1, and contains granular or powdered drugs such as freeze-dried drugs such as blood products, antibiotics, and anticancer drugs. It is sealed with a stopper 8 that can be pierced with a hollow needle. The container itself is made of glass or a synthetic resin with excellent chemical resistance such as polyethylene or polypropylene, and the stopper 8 is made of a rubber-like elastic material. As the rubbery elastic material, ethylene-propylene rubber, butyl rubber, nitrile rubber, acrylic rubber, etc. are preferably used because they have excellent chemical resistance.

The solution container 3 contains a solution or dilution solution such as physiological saline, 5% glucose solution, or distilled water for injection, and has a communication portion 9 that communicates with the drug container 2; Generally, the container is provided with a drug solution outlet 10 provided at the end opposite to the communication portion 9, and the container itself is generally formed of thermoplastic resin into a bag or bolt shape. The communication portion 9 is formed by closing a liquid passage 11 protruding from the bag body 1 side with a closing membrane 12. FIG. 9 shows an embodiment of a bag-shaped solution container, in which a communication portion 91 whose liquid passage 111 is closed by a thin closure membrane 121 is provided at the upper end of the solution container 31, and at the lower end thereof. A chemical solution outlet 101 is provided. Also the first
Figure 0 is an example of a bottle-shaped solution container,
The solution container 32 has a liquid passage 11 as shown in FIG.
2 is provided with a communication portion 92 closed by a closure membrane 122 and a drug solution outlet 102.

The cylindrical body 4 is a flexible part that is connected to the bag body 1 so as to communicate therewith, and is also connected to the outer wall of the communication part 9 of the solution container 3, and extends in the axial direction of the cylinder, that is, in the vertical direction in FIG. A flexible bellows-like material or a tube-like material made of a sheet or film of synthetic resin such as polyethylene, polypropylene, polyester, or vinyl chloride resin are used. However, only the upper and lower parts of the cylindrical body 4 may be formed to be flexible. Therefore, when the cylindrical body 4 is a sheet or a film tube, the cylindrical body 4 can be formed integrally with the bag 1 by narrowing the lower part of the bag to form a substantially cylindrical shape. Good too. Incidentally, in order to improve the sliding of the communication means on the inner surface of the cylindrical body 4, it is preferable to form fine protrusions or to form the inner surface into a rough surface.

The communication means 5 is arranged between the medicine container 2 and the solution container 3, and is for communicating the insides of these two containers 2 and 3. The communication means 5 is the bag body 1
At least a portion thereof is inserted into the cylindrical body 4, and is movable only in the axial direction of the cylindrical body 4. As the communication means 5, only a hollow needle having cutting edges at both ends (hereinafter referred to as a double-ended needle) may be used, but the double-ended needle 1
3 and a hub 14 that supports and fixes the needle 13 near its center, and one that is further provided with guides 15 and 16 that guide the drug container 2 and the communication portion 9 (see Fig. 1); It is preferable that a rubber cap 17 is attached to the cutting edge of this guided communication means (see FIG. 8). In the case of the communication means 5 made of synthetic resin, it is also possible to form the double-ended needle 13 and the hub 14 integrally. Also, double-ended needle 13
There are two types: one with one fluid passage and one with two fluid passages, but the one with two fluid passages is preferable because it allows the chemical solution to transfer smoothly. The communication means 51 shown in FIG. 8 is equipped with a rubber cap 17.
31 is a double-ended needle, 141 is a hub, 151 is a communicating portion guide, 161 is a bias guide, and 23 is a cutting edge on the communicating portion side. The communication means 5 is generally made of stainless steel or synthetic resin for the double-ended needle 13, and synthetic resin for the hub 14. As the synthetic resin, polypropylene, acrylonitrile-butadiene-styrene copolymer (ABS resin), polycarbonate, etc. are generally used.

The container support means 6 holds the drug container 2 and the solution container 3 at a predetermined distance, that is, at a predetermined distance so that the communication means 5 does not come into contact with the stopper 8 of the drug container 2 and the communication portion 9 of the solution container 3. It is a removable support for placing, supporting, and fixing objects, and is generally made of plastic foam such as expanded polystyrene, or thermoplastic resin such as polyethylene, polypropylene, polystyrene, and vinyl chloride resin.
It may be formed of metal, wood, cardboard, etc. At least the container supporting portion, that is, the portion that supports the drug container 2 and the solution container 3 from above the bag body 1 and the cylindrical body 4, has a cross-sectional shape that is approximately C-shaped. cleavage part (2 in Figures 2 and 3)
2. The container support means 6 may be inserted into the medicine container 2 or solution container 3 by pushing it into the drug container 2 or solution container 3 from 221 in FIGS. 4 to 6 or 222 in FIG. 7. The container support means 6 may be made of plastic foam as shown in FIGS. 2-3, cylindrical from thermoplastic resin as shown in FIGS. 4-6, or cylindrical as shown in FIG. An example is a C-shaped ring connected by a support.

The container support means 61 shown in FIG. 2 is formed into a cylindrical shape from foamed polystyrene, foamed polyurethane, foamed polyethylene, etc., and has a vial support portion 18 and a communication portion support portion 19. Figure 3 is A- in Figure 2.
It is a cross-sectional view taken along line A, and the cross-sectional shape is approximately C-shaped.

The container support means 62 in FIG. 4 is formed into a cylindrical shape from a thermoplastic resin such as polyethylene, polypropylene, polystyrene, polyester, or vinyl chloride resin, and includes a vial support portion 181 and a hub support portion 2.
0 and a communication portion support portion 191. Fifth
The figure and FIG. 6 are cross-sectional views taken along the lines B--B and C--C in FIG. 4, respectively, and the cross-sectional shape is approximately C-shaped.

The container support means 63 in FIG. 7 is made of thermoplastic resin similar to that in FIG.
82, the communication portion support portion 192, and the hub support portion 20
1 are connected by struts 21.

Next, how to use this infusion container will be explained.

When using the infusion container, first remove the container support means 6 from the infusion container, and then connect the drug container 2 to the communication means 5 while holding the drug container 2 and the communication means 5 by hand from above the bag body 1 and the cylindrical body 4. It is moved to the means 5 side, and the stopper 8 of the medicine container 2 is pierced with one cutting edge of the double-ended needle 13 of the communication means 5. Next, while grasping the solution container 3 at the base of the communication part 9, the drug container 2 pierced by the communication means 5 is inserted into the solution container 3.
The double-ended needle 13 is moved to the side, and the other cutting edge of the double-ended needle 13 is pierced through the obturator membrane 12 of the communicating portion 9 . With the above operation, the drug container 2 and the solution container 3 are communicated with each other, so when the solution container 3 is pressed by hand to transfer the solution to the drug container 2, the drug in the drug container 2 is dissolved in the solution. be done. After the medicinal solution is prepared in this way, the communication means 5
When the double-ended needle 13 has two fluid passages, if the infusion container is hung on a hanger (not shown) using the hanger hole 7, the drug solution will naturally flow into the solution container 3 due to gravity. to move to.
However, when the double-ended needle 13 has only one fluid passage, it is necessary to transfer the medicinal solution while pressing the dissolving solution container 3 by hand as if kneading it. Note that, if necessary, the operation of transferring the drug solution to the drug container 2 and returning it to the solution container 3 may be repeated.

<Effects of the Invention> As is clear from the above explanation, the infusion container of the present invention has the following advantages.

(1) By providing a container support means, when the infusion container is not in use, the drug container and the solution container are supported at a certain interval and separated so that they do not communicate with each other, and when in use, the drug container and solution container can be reliably and easily separated. It can be mixed with a solution.

(2) By accommodating the drug dissolver in a thermoplastic resin bag, the drug container is protected aseptically, and the drug and solution are sterilized by the communication between the bag and the cylindrical body. Can be mixed.

(3) After communication, the drug and solution can be mixed in a short time.

(4) The overall size can be made smaller than conventional similar products.

[Brief explanation of drawings]

FIG. 1 is a sectional view of essential parts of an infusion container according to an embodiment of the present invention, FIG. 2 is a front view of an embodiment of the container support means, and FIG. 3 is a sectional view taken along the line A-A in FIG. 2. , FIG. 4 is a sectional view showing another embodiment of the container support means,
5 is a sectional view taken along the line B-B of the container support means shown in FIG. 4, and FIG. 6 is a cross-sectional view taken along the line C--
A sectional view taken along line C and FIG. 7 are perspective views showing another embodiment of the container support means. 8 is a sectional view showing an embodiment of the communication means, FIG. 9 is an explanatory diagram showing an embodiment of the solution container, and FIG. 10 is an explanatory diagram showing another embodiment of the solution container. FIG. 11 is a diagram illustrating a similar conventional infusion container. <Explanation of main symbols>, 1: Bag body, 2: Drug container, 3, 31, 32: Solution container, 4: Cylindrical body,
5, 51: Communication means, 6, 61, 62, 63: Container support means, 7: Hanger hole, 9, 91, 92:
Communication part, 10, 101, 102: Chemical solution outlet, 1
1,111,112: Liquid passage, 12,121,
122: Obturator membrane, 13, 131: Double-ended needle, 14,
141: Hub, 15, 151: Communication part guide, 1
6,161: Vial guide, 17: Rubber cap.

Claims (1)

[Claims] 1. A thermoplastic resin bag housing a drug container;
A drug container was housed in the bag in an inverted state, and the opening was sealed with a stopper that could be pierced with a hollow needle, and the liquid passageway was closed by a closure membrane that could be pierced with a hollow needle. A solution container having a communication part and a drug solution outlet on the opposite side of the communication part and containing a solution or a dilution solution therein; a flexible cylindrical body connected to the communication portion; a flexible cylindrical body housed in the bag and at least a part of which is movably inserted into the cylindrical body only in the axial direction; Part 2 in between
a communication means consisting only of a hollow needle or having a hollow needle provided therein, communicating the insides of the two containers; and a cylinder communicating and connecting the drug container and the solution container in order to support and fix the two containers at a predetermined interval. An infusion container capable of aseptically dissolving or diluting a drug, comprising a removable container support means fitted to the outside of the container. 2. The infusion container according to claim 1, wherein the inner surfaces of the bag body and the cylindrical body are formed into rough surfaces. 3. The infusion container according to claim 1, wherein fine protrusions are formed in the longitudinal direction on the inner surfaces of the bag body and the cylindrical body. 4. Claim 1, wherein the container support means is a support that is fitted into the opening of the drug container and the communication portion of the solution container from above the bag, and whose cross-sectional shape at least at the container support portion is substantially C-shaped. The infusion container according to any one of items 3 to 3. 5. The infusion container according to claim 4, wherein the container support means is made of flexible resin. 6. The infusion container according to claim 4, wherein the container support means is formed of plastic foam. 7. The infusion container according to any one of claims 1 to 6, wherein the solution container is a bag made of thermoplastic resin. 8. The infusion container according to any one of claims 1 to 6, wherein the solution container is a plastic bottle. 9. The infusion container according to claim 7 or 8, wherein the closure membrane is formed separately from the communication portion. 10. The infusion container according to claim 7 or 8, wherein the closure membrane is formed integrally with the communication portion. 11. The infusion container according to claim 10, wherein the communication portion is formed integrally with the solution container. 12. The infusion container according to any one of claims 1 to 3, wherein the communication means is a hollow needle having a hub in the middle and cutting edges at both ends. 13. The infusion container according to claim 12, wherein at least the cutting edge of the needle on the side of the solution container is covered with a rubber cap. 14. Claim 12 or 13, wherein the hub is provided with a guide means so that the hollow needle can reliably pierce the stopper of the drug container and the communicating portion of the solution container.
The infusion container described in . 15. The infusion container according to any one of claims 12 to 14, wherein the hollow needle is made of thermoplastic resin. 16 Claim 12 wherein the hollow needle is made of metal.
15. The infusion container according to any one of items 1 to 14. 17. The infusion container according to any one of claims 1 to 3, wherein the cylindrical body is formed integrally with the bag body.