WO1993025175A1

WO1993025175A1 - Medical container

Info

Publication number: WO1993025175A1
Application number: PCT/JP1993/000789
Authority: WO
Inventors: Kouji Umekita; Satoshi Taguchi
Original assignee: Roussel Morishita Co., Ltd.
Priority date: 1992-06-16
Filing date: 1993-06-11
Publication date: 1993-12-23
Also published as: FI940699A; JPH0686738U; EP0598918A1; EP0598918A4; CA2113808A1; FI940699A0

Abstract

A sealed dissolving liquid container (1) and a bottomed cylindrical case (3) having an air vent through bore (8) are connected together via a joint member (4), and a cylindrical drug bottle fixing jig (13) into which a drug vial (2) is inserted with its mouth portion facing downward is movably set in the case (3), a sealed space being thus formed between the drug vial fixing jig (13) and a bottom portion of the case (3). The drug bottle (2) and dissolving liquid container (1) are allowed to communicate with each other quickly by a double ended needle (16) with the sealed condition retained. This medical container enables a drug dissolving operation to be carried out speedily and aseptically during a drip treatment, requires little storage space, and has a smaller number of parts and a smaller total length.

Description

Specification

Medical container

Technical field

The present invention relates to a medical container capable of dissolving a solid drug such as a powdered drug or a freeze-dried drug in a dissolving solution such as a saline solution or an aqueous glucose solution in a sealed container at the time of use as an injection, and administering the solution by infusion. US. Background art

Some antibiotics and blood products are supplied to medicine as solid preparations due to problems of pharmaceutical stability, and are dissolved immediately before use and administered intravenously as injections. Heretofore, the drug dissolving operation has conventionally been performed by mutually connecting the drug vial and the dissolving solution container each sealed with a rubber stopper with a hollow double-ended needle having cutting edges at both ends. If such a communicating operation is performed in a state where the rubber stoppers and the hollow double-ended needles of both containers are exposed to the outside air, there is a risk that the medicine is contaminated.

Therefore, various medical containers have been proposed in which the communication operation between the drug vial and the solution container can be performed in a sealed system. For example, Japanese Patent Application Publication No. Sho 61-501112 discloses that a capsule containing a drug vial and a flexible dissolving solution container are connected by a conduit means, and the conduit means is provided with a communicating means. Medical containers are disclosed. Further, Japanese Patent Application Laid-Open No. 2-12777 discloses a medical container in which a communication mechanism is improved so that the communication operation can be performed easily and reliably.

The medical container disclosed in the above-cited Japanese Patent Application Publication No. Sho 61-501111 has a problem that the communication operation is troublesome.

The medical container disclosed in the above-mentioned Japanese Patent Application Laid-Open No. 2-12777 has a communication operation Although the simplification of the operation has been considerably improved, the communication must be performed by rotating the cap, and it is said that it has the simplicity corresponding to the emergency medical scene that requires rapid drug administration. hard. In addition, since the medical container has a long overall length and a large number of parts constituting the container, the storage space for the medicine is narrow, and the medical site requires a lot of expense for disposal of used medical equipment. It's hard to say.

On the other hand, if the total length of the medical container is too long, the head between the medical container and the drip administration site will be small, and the injection pressure into the vein will decrease, and in extreme cases, a needle placed in the vein Blood may flow backwards and cannot be infused. Therefore, it is necessary to make the overall length of the medical container as short as possible so as not to hinder the infusion by natural fall.

SUMMARY OF THE INVENTION The present invention has been made to solve such a conventional problem, and can rapidly communicate a drug vial and a dissolution solution container while maintaining a sealed system. An object of the present invention is to provide a medical container that can perform a dissolving operation promptly, does not require a storage space, can reduce the number of parts, and can shorten the overall length. Disclosure of the invention

In order to solve the above-mentioned problems, the present invention has a connection port portion sealed with a thin film, is sealed with a sealed solution container, and a stopper made of an elastic material. A bottomed cylindrical case having a connecting pipe at the bottom that is connected by fitting and having a through hole for exhaust in the body, and at least one air vent hole in the flange, and a recess in the bottom. An opening is provided in the case, and a fixing jig held movably in the axial direction in the case, and a part sealed with a stopper made of an elastic material are fitted into the recess, Fixed A medicine vial held in the case, movably with the jig, and a sealed space formed on the bottom side of the mouth of the medicine vial, movably held in the axial direction; A hollow double-ended needle having a case, each stopper of a drug vial, and a hub formed to be piercable into the thin film and maintaining a constant piercing depth, and a state before the drug vial is pushed into the case. In this case, the through hole is closed, the hermetic state of the closed space is maintained, and when the medicine vial is pushed into the case, a first shielding body detached from the through hole, and the medicine vial with respect to the case. In a state before being pushed in, the hermetically sealed state of the closed space is maintained together with the first shield, and the double-ended needle moves the case, each stopper of the drug vial, and the thin film to a certain depth. When penetrating, the through-hole is closed, and a second shield for maintaining the hermetically sealed state of the closed space is provided.

According to the present invention, a dissolving solution container, a cylindrical case with a bottom, a drug vial, a cylindrical drug vial fixing jig inserted with its mouth downward, and a hollow double-head having a hub in the middle It has a needle, a through-hole provided in the case, and a detachable shield provided in the through-hole, so that the drug vial and the dissolution liquid container can be sterilized by a simple operation of pressing the drug vial. Communication can be achieved quickly and appropriately, and the dissolution operation of the drug can be performed quickly.

Moreover, according to the medical container according to the present invention, when the dissolved drug is infused, the drug vial is held in a state of being pushed into the case, so that the entire length of the container is short, and the medical container is infused with drip. The drop between the parts can be made sufficiently large.

Furthermore, according to the medical container according to the present invention, since the number of parts is small and the shape of the container is small, the amount of used waste is small. In particular, according to the medical containers according to the third and fourth embodiments, Easy separation and disposal. BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a perspective view of a medical container according to a first embodiment of the present invention, FIG. 2 is an exploded perspective view of the medical container shown in FIG. 1, and FIG. FIG. 4 is a longitudinal sectional view of a medicine vial fixing jig in a container, FIG. 4 is a longitudinal sectional view of a double-ended needle in the medical container shown in FIG. 1, and FIG. 5 is a case of the medical container shown in FIG. FIG. 6 is a partially cutaway front view showing a state before the communication operation of the medical container shown in FIG. 1, and FIG. 7 is a state immediately after the communication operation of the medical container shown in FIG. 1 is started. FIG. 8 is a partially broken front view showing a state when the communication operation of the medical container shown in FIG. 1 is completed, and FIG. 9 is a partially broken front view showing the state of the present invention. FIG. 10 is a cross-sectional view of a medical container according to an embodiment, FIG. 10 is a perspective view of a medical container according to a fourth embodiment of the present invention, and FIG. FIG. 12 is a partially cutaway front view of the medical container shown in FIG. 0, FIG. 12 is a perspective view of a medical container according to a fifth embodiment of the present invention, and FIG. 13 is a third embodiment of the present invention. It is sectional drawing of the medical container which concerns on. Detailed description of the embodiment

Hereinafter, an embodiment of the present invention will be described with reference to the accompanying drawings.

1 to 8 show a medical container according to a first embodiment of the present invention, wherein 1 is a solution container, 2 is a drug vial, 3 is a cylindrical case with a bottom, and 4 is a connecting portion.

Dissolution liquid container 1 is a flexible container made of a material such as thermoplastic polyolefin resin, soft vinyl chloride resin, or ethylene-vinyl acetate copolymer, and has a thin film 3 2 on top (see Fig. 6). It has a connection port 5 sealed with, and a drug solution outlet 9 sealed at the bottom with a rubber stopper, and is filled with a solution. The drug vial 2 is a drug-containing container whose mouth is sealed with a rubber stopper. The bottom of the case 3 includes a hollow connection pipe 6 formed integrally with the main body of the case 3. The case 3 is provided with a flange at the upper end thereof, a hanging member 7 and a hanging member pivot 10 at the upper part of the outer wall, and four through holes 8 at substantially the center of the outer wall. The hanger 7 is pivotally supported by a hanger pivot 10 provided on the outer wall of the case 3.

The connecting portion 4 is composed of the connecting pipe 6 and the connecting port 5 described above, and both are fitted and locked in an airtight manner.

Next, the structure of the medical container of the above embodiment will be described in detail with reference to FIGS. As shown in FIG. 2, the drug vial 2 is placed with its mouth 11 down, and the mouth 11 is fitted into the recess 14 of the drug vial fixing jig 13. The annular packing 23 is installed in an annular groove 12 formed in the body of the drug vial 2. The annular packing 24 is mounted in an annular groove 15 formed in a flange portion of the drug vial fixing jig 13. As described above, the drug vial 2 and the drug vial fixing jig 13 are hermetically and movably inserted into the case 3 via the annular packings 23 and 24. An enclosed space is formed between the medicine vial fixing jig 13 and the bottom of the case 3, and a double-ended needle 16 is installed in the enclosed space.

As shown in FIG. 3, the drug vial fixing jig 13 has an opening 26 through the blade surface of the double-ended needle 16 at the bottom of the recess 14. Further, at least one air vent hole 25 penetrating vertically is provided in the flange portion of the drug vial fixing jig 13. The material of the drug vial fixing jig 13 is preferably hard plastic or rubber. It is also possible to mold the annular packing 24 integrally with the drug vial fixing jig 13 c. The material of the annular packing 24 is a soft plastic such as polystyrene. Silicon rubber, butadiene rubber, isoprene rubber and the like are preferred.

As shown in FIG. 4, the double-ended needle 16 has a hub 27 that maintains a constant penetration depth when a rubber stopper 30 (see FIG. 6) is inserted between the two vials. It has a locking portion 17 for locking the needle 16 in an annular groove 20 formed in the inner wall of the case 3 and a liquid leakage preventing portion 18. As the material of the double-ended needle 16, a stainless steel metal needle or a hard plastic resin is preferable.

As shown in FIG. 5, the case 3 has three annular grooves 19, 20 and 21 formed on the inner wall thereof. A through hole 8 is formed in a part of the annular groove 20. The connecting tube 6 located at the bottom of the case 3 has a through hole 29 into which the connecting portion rubber stopper 22 (see FIG. 2) is fitted, and a connecting portion fitting protrusion 31 of the solution container 1 (see FIG. 6). It has a fitting groove 28 for fitting.

As shown in FIG. 6, the medicine vial 2 and the medicine vial fixing jig 13 are arranged in a state where the annular packing 23 is in close contact with the annular groove 19 and the annular packing 24 is in close contact with the annular groove 20. Inserted into case 3.

As described above, by inserting the drug vial fixing jig 13 into the case 3, a sealed space is formed between the drug vial fixing jig 13 and the bottom of the case 3. The annular packing 23 can prevent outside air from entering the closed space, and assure sterility in the closed space. The two annular packings 23, 24 force, which fit into the annular grooves 19, 20, respectively, cause vibrations during transportation, etc., so that the position of the drug vial fixing jig 13 in the case 3 Is prevented from fluctuating. In the through hole 8, an annular packing 24, which is a shield that is released by pressing the bottom of the drug vial 2, is located.

'Next, refer to Figs. 7 and 8 for how to use the medical container described above. I will explain.

FIG. 7 shows a state immediately after the communication operation between the drug vial 2 and the solution container 1 is started, and FIG. 8 shows a state after the communication operation is completed. To make the drug vial 2 and the dissolution liquid container 1 communicate with each other, first, the bottom of the drug vial 2 is pressed downward. More specifically, the bottom surface of the drug vial 2 is pushed down with a finger, and the drug vial fixing jig 13 is lowered toward the solution container 1. By this operation, the two annular packings 23 and 24 come off the annular grooves 19 and 20. At the same time as the annular packing 24 comes off the annular groove 20, the through hole 8 closed by the annular packing 24 is opened.

Further, the air in the closed space in the case 3 which is reduced by the lowering of the drug vial fixing jig 13 is discharged from the through hole 8 to the outside of the case 3 through the air vent hole 25. This exhaust allows the drug vial fixing jig 13 holding the drug vial 2 to easily descend without being pushed back by the air in the reduced sealed space. When the drug vial fixing jig 13 is further pushed down, the tip of the locking portion 17 of the double-ended needle 16 is disengaged from the annular groove 21, and the double-ended needle 16 descends toward the solution container 1. As a result, as shown in FIG. 8, the connecting portion rubber stopper 22 and the thin film 32 of the connecting portion 4 and the drug vial opening rubber stopper 30 on the opposite side are instantaneously pierced by the double-ended needle 16. At this time, the annular packing 23 fits into the annular groove 20 and closes the through hole 8 again. Further, the annular packing 23 is fitted in the annular groove 20 and the annular packing 24 is fitted in the annular groove 21, thereby preventing the vial fixing jig 13 from being lifted.

After the drug vial 2 and the dissolution liquid container 1 are communicated with each other, make them horizontal or lift the dissolution liquid container 1 higher than the drug vial 2 and press the wall surface, and the dissolution liquid is put into the drug vial 2. Transfer and dissolve the drug. After the drug is completely dissolved, return the solution to the solution container 1 and attach the hanging device 7 to the infusion stand Attach the infusion set to the solution outlet 9 of the dissolution solution container 1 by hanging it on the solution and inject it intravenously into the patient.

FIG. 9 shows a medical container according to a second embodiment of the present invention. As shown in the figure, in the present embodiment, the outer wall of the drug vial fixing jig 13 is extended to the body of the drug vial 2. Further, the present embodiment is different from the medical container shown in FIGS. 1 to 8 in that the annular groove 12, the annular groove, and the ッ kin 23 に are not arranged in the body of the drug vial 2. In this embodiment, the drug vial 2 is hermetically inserted into the drug vial fixing jig 13 with its mouth downward, and an annular groove is formed on the outer wall of the drug vial fixing jig 13. An annular packing 33 is mounted.

With the above configuration, it is not necessary to form the annular groove 12 in the body of the drug vial 2, and a glass vial bottle that is usually used as a drug vial can be used.

Other configurations are substantially the same as those of the embodiment shown in FIGS.

FIG. 13 shows a medical container according to a third embodiment of the present invention, in which a shielding body for shielding a through hole 8 is replaced with an annular packing 24 and a locking portion 17 of a double-ended needle 16 and Other than the above, it is substantially the same as the medical container shown in FIGS. 10 and 11 show a medical container according to a fourth embodiment of the present invention.

As shown in FIG. 11, the medicine vial fixing jig 13 of the present embodiment has an outer wall extending to the bottom of the medicine vial 2. The drug vial fixing jig 13 has a flange portion below and a flange portion 34 (see FIG. 10) including an outer flange portion 37 and an inner flange portion 38 at an upper end portion. Further, the drug vial fixing jig 13 of the present embodiment is provided with a convex portion 35 and a cutout λ portion 36 at least at two places on the body side wall. Further, the drug vial fixing jig of the present embodiment 13 is provided with an annular packing 39 tightly attached to the drug vial 2 on the inner wall of its body.

In the medical container of the present embodiment, the rising of the drug vial 2 that occurs when the double-ended needle 16 penetrates the drug vial mouth rubber stopper 30 and the thin film 32 and the connecting portion rubber stopper 22 with the drug vial This is prevented by an inner flange 38 provided on the fixing jig 13 and a wedge-shaped projection 35 at the bottom. The lifting of the drug vial 2 is caused by the fact that when the drug vial fixing jig 13 is lowered by the communication operation of pressing the bottom surface of the drug vial 2, the convex portion 3 5 comes into contact with the inner wall of the case 3. The side wall at the top of the fixing jig 13 is deformed inward toward the axis, and the deformation of the side wall prevents the inner flange 38 from pressing the bottom of the drug vial 2.

Further, the medical container of the present embodiment has a feature that it can be easily separated and discarded after use. After using the medical container of the present embodiment, pull out the outer flange 37 provided at the upper end of the drug vial fixing jig 13 and take out the drug vial fixing jig 13 from the case 3. Can be. After taking out the drug vial fixing jig 13, grasp the drug vial 2 attached to the drug vial fixing jig 13 with your finger on the side wall of the drug vial 2 exposed from the cutout 36, and pull it up. Can be taken out.

The annular packing 39 provided on the inner wall of the body of the drug vial fixing jig 13 prevents the airtightness inside the case 3 from being impaired due to the variation in the body diameter of the drug vial 2 caused by mass production. are doing. Note that the three annular packings 24, 33, and 39 provided on the drug vial fixing jig 13 may be mounted around the drug vial fixing jig 13 after forming an annular groove. However, it can be formed integrally with the drug vial fixing jig 13.

FIG. 12 shows a medical container according to a fifth embodiment of the present invention. As shown in the figure, a through hole 8 is provided in an annular groove 21 in which the double-ended needle 16 is locked, and a shield for opening and closing the annular groove 21 is provided as a locking portion 17 of the double-ended needle 16. Other configurations are substantially the same as the medical container shown in Figure 10.1.11.

Claims

The scope of the claims

1. a connection tube having a connection port sealed with a thin film, a sealed solution container, and a connection pipe sealed by a stopper made of an elastic material and connected by fitting into the connection port. A bottomed cylindrical case having a through hole for exhaust in the body, at least one air vent hole in the flange, and an opening in a recess in the bottom, A fixing jig held movably in the axial direction in the case, and an opening sealed with a stopper made of an elastic material is fitted into the recess so as to be movable together with the fixing jig. A drug vial held in the case, and a stopper, which is movably held in the axial direction in a sealed space formed on the bottom side of the mouth of the drug vial, and each stopper of the case and the drug vial. , And pierceably formed in the membrane And a hollow double-ended needle having a hub for keeping the penetration depth constant, and before the medicine vial is pushed into the case, the through hole is closed to maintain the hermetically sealed state of the closed space. A first shield that separates from the through-hole when the drug vial is pushed into the case; and a first shield before the drug vial is pushed into the case, When the double-ended needle penetrates the case, each stopper of the drug vial, and the thin film to a certain depth, the through hole is closed, and the hermetic state of the sealed space is maintained. Medical use characterized by having a shield ^ ^

2. The medical device according to claim 1, wherein the first shield is provided on an outer peripheral portion of the fixing jig, and the second shield is provided on an outer peripheral portion of the medicine vial. container. -

3. The medical container according to claim 1, wherein the first and second shields are provided on an outer peripheral portion of the fixing jig.

4. The medical container according to claim 1, wherein the first shield is provided on an outer edge of a hub of the double-ended needle.

5. The fixing jig is provided with an outer flange at an end opposite to the recess, an inner flange for holding a bottom of the drug vial, and a cutout. The medical container according to claim 3 or 4, wherein the medical container is a medical container.

6. The fixing jig has a wedge-shaped outer projection on the lower end, which engages with the end of the case when the medicine vial is pushed into the case. 6. The medical container according to claim 5, wherein: