JPH07275324A - Container for liquid transfusion and method for manufacturing the same container for solution - Google Patents

Abstract

PURPOSE:To provide a container for liquid transfusion capable of mixing safely and sterilely pharmaceutical preparations and solutions. CONSTITUTION:A container for liquid transfusion comprises a container 1 for pharmaceutical preparations having a mouth sealed with a pierceable stopper, a vial holder 6 for holding inside thereof the container 1 for pharmaceutical preparations, a pressure- deformable synthetic resin container l for solutions having at one end thereof a chemicals bleeding port 23 and the other end thereof an opening communicated to the container 1 for pharmaceutical preparations and closed fluid-tight with a membrane, and mounted with a cylindrical guide 4 surrounding said opening concentrically, a double ended needle 3 contained in the guide 4 for the container 1 for solutions, slidably in the vertical direction, and a cap 5 containing the vial holder 6 and sealing rotatably an opening of the guide 4. Further, a means for pushing down the container for pharmaceutical preparations is provided for moving downwardly the container 1 for pharmaceutical preparations cooperatively at the inner wall of the cap 5, the inner wall of the guide 4 and the outer wall of the vial holder 6, such that the vial holder 6 moves downwardly without rotation thereof to reach the double ended needle when the cap 5 is rotated.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a container for infusion. More specifically, a dry drug such as a powder formulation or a freeze-dried drug and its solution are stored in a separated state, and the dry drug and the solution are aseptically mixed in a container immediately before use to prepare an infusion solution. The present invention relates to an infusion container for supplying.

[0002]

2. Description of the Related Art Conventionally, in a medical institution such as a hospital, a dry drug contained in a drug container such as a vial is dissolved in a solution such as distilled water, physiological saline or glucose solution. It is used for drip injection. In order to be able to use it easily in such a case, the vial containing the dried drug is connected in series to the dissolution liquid container containing the dissolution liquid, and the two containers should be aseptically connected during use. The infusion container has been proposed (Japanese Patent Publication No. 61-501129, Japanese Patent Laid-Open No. 2-1277, Japanese Utility Model Laid-Open No. 63-135642, etc.).

The one disclosed in Japanese Patent Publication No. 61-501129 has a capsule containing a medicine container and a dissolution liquid container containing a dissolution liquid connected by a tube, and is provided in the tube. The drug container and the solution container are communicated by the communicating means, and the drug and the solution are aseptically mixed. In addition, JP-A-2-1277
As shown in FIG. 29, what is disclosed in the publication is a drug solution container 112 and a solution container 111 containing a solution.
A hollow puncture needle 117 having a hub in the middle and blade edges at both ends is interposed between the and, and the drug container 112 is first pierced by the puncture needle 117, and then the dissolution liquid container 111 is pierced. Drug container 112 and dissolution liquid container 11
1 is a container for infusion, which ensures reliable and easy communication with 1, and enables aseptic mixing of a drug and a solution after communication.

In Japanese Utility Model Application Laid-Open No. 63-135642, a cylindrical support ring which can be appropriately detached is provided at the sealing portion of the mouth of the solution container, and a double-ended needle is slidable up and down on the support ring. Installed,
When the double-ended needle is slid downward, the lower needle body punctures the seal portion at the mouth of the dissolution liquid container.

In these infusion containers, it is necessary to basically connect a medicine container and a dissolution liquid container in a divided state, and to provide a means for mixing the medicine and the dissolution liquid in both containers at the time of use at the connection portion. Therefore, there is a problem in that the entire length of the infusion container (the length in the connecting direction) is inevitably long, the transportation cost is high, and it is difficult to secure a storage space. In addition, in addition to the inconvenience of handling an infusion container, there is an inconvenience that the hanger must be raised in the hospital in order to make a sufficient drop for spontaneous dropping. Of course, each of these infusion containers is a container in which a vial, which is a general distribution form of a dry drug, is directly incorporated and integrated, and in that sense, it is highly versatile.

However, these conventional infusion containers, for example, the infusion container disclosed in Japanese Patent Publication No. 61-501129 has a large number of parts, and it takes time to fold the breaking member by hand to open the passage. In short, if the breaking member is incompletely broken, it has a drawback that it is difficult for the liquid to pass through and the dissolution takes time. In addition, the infusion container disclosed in Japanese Patent Laid-Open No. 2-1277 relates to prevention of contamination of internal medicine and simplification of communication between the medicine container and the dissolution liquid container.
Although it is considerably improved as compared with the infusion container disclosed in JP-A-61-501129, the parts such as the communication sequence regulating means are complicated and the total number of parts is large. Furthermore, the infusion container disclosed in Japanese Utility Model Laid-Open No. 63-135642 has a small number of parts and is relatively easy to operate, but requires a relatively large force for communication, and after the drug and the solution are mixed, the support ring and It is necessary to connect an infusion set etc. to the seal part at the mouth of the dissolution liquid container after removing the double-headed needle and inverting the dissolution liquid container and removing the double-headed needle. There is a possibility that the mixed chemical liquid may leak.

The present invention has been made in view of the above circumstances, and is easy to operate, hassle-free, there is no risk of leaking a mixed drug solution, the number of parts is small, and the drug is aseptically dissolved. One of the objects is to provide an infusion container capable of mixing liquids. Another object of the present invention is to
The purpose is to shorten the total length of the infusion container, thereby lowering transportation costs, facilitating storage in hospitals, etc., and adapting to the mass transportation era, and facilitating handling in hospitals.

[0008]

In order to solve the above problems, the present invention provides a drug container whose mouth is sealed with a pierceable stopper, and a vial holder for holding the drug container therein. Pressing having a drug solution outlet and a communication port for a drug container closed in a liquid tight manner with a thin film at both ends thereof and surrounding said communication port and being provided with a cylindrical guide portion concentrically therewith. A deformable solution container made of synthetic resin, a double-ended needle that is vertically slidably accommodated in the guide part of the solution container, a vial holder, and a cap that rotatably seals the open end of the guide part. And further provided on the inner wall of the cap, the inner wall of the guide portion and the outer wall of the vial holder, drug container pressing means for cooperatively moving the drug container downward, and the vial holder rotating when the cap is rotated. Na By moving downward to reach the double-ended needle, and further downward with the double-ended needle, the stopper of the mouth of the drug container and the thin film of the communication port of the solution container held by the vial holder are pierced by the double-ended needle, respectively. Provided is an infusion container which is passed through and allows a drug container and a dissolution liquid container to communicate with each other. The lower end of the guide portion may be embedded in the dissolution liquid container, and the communication port may be formed in the embedded lower end.

According to the present invention, there is provided a specific drug container pressing means for moving the drug container downwards in cooperation with the inner wall of the cap and the inner wall of the guide portion and the outer wall of the vial holder, mainly by the combination of the groove and the protrusion or the ridge. By providing the above, the operation can be made extremely easy and the leakage of the chemical liquid can be eliminated. Here, the drug container pressing means moves downward without rotating the vial holder to reach the double-ended needle when the cap is rotated, and further moves downward together with the double-ended needle, whereby the drug container held in the vial holder is held. The thin film of the mouth plug and the communication port provided in the guide part of the solution container are pierced by the double-ended needles, respectively, so that the drug container and the solution container can be communicated with each other. Here, the order of piercing is preferable when the stopper at the mouth of the drug container is first used and the thin film at the communication port is subsequently performed, because leakage of the chemical liquid can be prevented.

Specifically, a plurality of parallel spiral grooves obliquely running downward provided on the inner wall of the cap, a plurality of vertical running grooves provided on the inner wall of the guide portion, and an upper end of the outer wall of the vial holder. A plurality of first engaging projections provided in the vicinity of the portion and slidably fitted in the spiral groove, and slidably fitted in the longitudinal groove provided in the vicinity of the lower end portion of the outer wall of the vial holder. And a plurality of second engaging protrusions.

Further, a spiral ridge may be used instead of the spiral groove of the cap, in which case the first engaging protrusion of the vial holder is arranged so as to contact the spiral ridge. Further, a protrusion corresponding to the first engaging protrusion of the vial holder may be formed on the cap, and in this case, the spiral groove is formed on the vial holder and the second engaging protrusion is formed to form the vertical groove of the guide portion. Combine. Further, a first engaging protrusion and a vertical groove corresponding to the vertical groove of the guide portion are formed on the vial holder, and a protrusion corresponding to the second engaging protrusion of the vial holder is formed on the guide portion to form a spiral groove of the cap. It is also possible to combine with.

Referring to FIG. 1, the structure and operation of the drug container pressing means will be described. The second engaging projection 62 of the vial holder 6 fitted on the drug container 1 is fitted into the longitudinal groove 41 of the guide portion 4. The first engaging protrusion 61 of the vial holder 6 is fitted in the spiral groove 51 of the cap 5. With this configuration, when the cap 5 is rotated clockwise,
The vial holder 6 has the second engaging projection 62 and the vertical groove 41.
The first engaging protrusion 61 moves downward while sliding along the spiral groove 51 of the cap 5 because it does not rotate together with the cap 5. Therefore, when the cap 5 is rotated in the clockwise direction, the medicine container 1 moves downward together with the vial holder 6, and the mouth portion 1 of the medicine container 1 is first moved.
The rubber plug 12 of No. 1 is pierced by the upper puncture needle of the sharp edge of the double-ended needle 3, and then the thin film 47 of the communication port 46 formed at the lower end of the guide unit 4 is pierced by the lower puncture needle of the beveled edge. Passed through. In this way, the communication operation between the drug container 1 and the solution container 2 is extremely easily achieved by rotating the cap 5.

In the present invention, the dissolution liquid container is provided with a cylindrical guide portion that surrounds the communication port with the drug container and is concentric therewith, and preferably the lower end of the guide portion is inside the dissolution liquid container. Since it is integrally embedded in the container, the total length of the infusion container (the length in the connecting direction between the drug container and the solution container) can be made significantly shorter than that of conventional containers, which can be used in hospitals, etc. Storage can be facilitated, compactness suitable for transportation can be obtained, and transportation cost can be reduced.

Further, in a hospital, it is possible to secure a head for realizing natural infusion of an infusion solution without using a high stand. Further, as shown in FIG. 29, the bottom part of the guide part and the communication port of the dissolution liquid container are not formed separately, but in the present invention, the guide part having the communication port formed at the lower end part is not the dissolution liquid container. Since it is integrally molded as a part of, the complicated structure for sealingly connecting both parts can be omitted and the number of parts can be reduced.

The solution container having the guide portion integrally formed as described above can be manufactured by a molding method mainly including a blow molding method as follows. That is, after blowing the synthetic resin parison introduced into the split mold, the blowing port is cut, the lower mold is pressed and set on the bottom side of the parison, and the mandrel is inserted from the blowing port side. By blowing and releasing from the mold, it has a drug solution outlet and a communication port with a drug container closed by a thin film at both ends thereof, and the communication port is surrounded by a cylindrical shape concentric with the communication port. It is possible to obtain a press-deformable synthetic resin solution container having a guide portion.

Here, the lower end portion (thin film) of the guide portion is a space (for example, 100 to 100) between the tip of the mandrel and the tip of the lower mold.
800 μm). The terms used in this specification, such as the vertical direction, push-down, and descent, indicate the direction when the infusion container is in a normal use state, and it is easy to understand the structure of the infusion container. It is for doing.

[0017]

Embodiments of the present invention will now be described with reference to the drawings. As shown in FIG. 1, the infusion container of the present invention is mainly composed of a drug container 1, a solution container 2, a double-ended needle 3, a guide portion 4, a cap 5, and a vial holder 6,
The lower end of the guide part 4 is integrally embedded in the solution container 2, and the open end of the upper end thereof is sealed with a cap 5. In the guide part 4, the double-ended needle 3 and the mouth part 11 of the drug container 1 are inserted. The vial holder 6 with the downward direction is accommodated so as to be slidable downward. Further, the drug container 1 is attached to the vial holder 6 with its mouth portion 11 exposed. Then, when the cap 5 is rotated clockwise, the medicine container 1
Goes down together with the vial holder 6, and the double-ended needle 3 pierces the rubber stopper 12 of the drug container 1 and the thin film 47 of the communication port 46 formed at the lower end of the guide portion 4 to connect both containers 1 and 2. Is configured.

The drug container 1 is generally made of glass, as shown in FIG.
As shown in FIG. 2, the mouth 11 is sealed with a sealing member having a self-sealing property such as a rubber stopper 12 which can be pierced by the double-ended needle 3. The rubber stopper 12 is further covered with a cover member 13 made of aluminum or the like. It is fastened by winding and is fixed to the mouth 11. A commercially available drug container can be used as the drug container 1. When assembling the infusion container, the top surface of the cover member 13 is removed and a through hole 14 is formed at a position where the double-ended needle 3 is punctured by the puncture needle. To be done. The drug container 1 is made of synthetic resin, and the outer wall of the body portion 15 has engagement protrusions corresponding to the first engagement protrusion 61 and the second engagement protrusion 62 of the vial holder 6 as shown in FIG. Although the vial holder 6 may be provided, the vial holder 6 may be omitted, but in the case of glass as in this example, it is difficult to form the engaging protrusion on the drug container, so the vial holder 6 is formed of synthetic resin. It is preferable to insert the drug container 1. In addition, although a dry preparation such as a powder preparation or a freeze-dried preparation is contained in the medicine container 1, it is omitted in the drawing. Specifically, the following are examples of dry formulations. Antibiotics include cefazolin sodium, ceftizoxime sodium, cefotiam hydrochloride, cefmenoxime hydrochloride, cefacetril sodium, cefamandole sodium, cephaloridine, cefotaxime sodium, cefotetan sodium, cefoperazone sodium, cefsulodin sodium, cef Cephem antibiotics such as tesol sodium, cefpyramide sodium, cefmetazole sodium, cefuroxy sodium, cefocles sulfate, ampicillin sodium, carbenicillin sodium,
There are penicillin antibiotics such as sulbenicillin sodium and ticarcillin sodium. As an antitumor agent,
Examples include mitomycin C, fluorouracil, tegafur, and cytarabine. Anti-ulcer agents include famotidine, ranitidine hydrochloride, cimetidine and the like.

The vial holder 6, which functions as an auxiliary tool for accommodating and holding the drug container 1 as shown in FIG. 1 and for moving the drug container 1 downward so as not to rotate, is usually a polyethylene resin. Polypropylene resin, polyester resin, polyvinyl chloride resin,
It is made of synthetic resin such as polycarbonate resin or ABS resin, and as shown in FIGS. 6 and 7, a bottom portion 63 as an upper end portion, a mouth portion 64 as a lower end portion, and a body portion 6 are formed.
It is a tubular member composed of 5. A plurality of first engaging projections 61 (two axially symmetrically formed in the figure) are fitted into the spiral groove 51 of the cap 5 described later and move downward along the spiral groove 51 on the bottom portion 63. And a through hole 66 for removing air when the drug container 1 is inserted,
A plurality of second engagement projections 62 (first engagement in the bottom view in the figure) which are fitted into a longitudinal groove 41 of a guide portion 4 described later and move downward along the longitudinal groove 41 in the mouth portion 64. Protrusion 61
2 are formed at the same position as above), and an annular projection 68 is formed to hold the medicine container 1 so as not to drop it. The mouth portion 64 may preferably be provided with a plurality of slits 67 to facilitate insertion of the drug container 1.
When the cap 5 can be removed, a handle 69 may be provided on the top surface of the vial holder 6 so that the drug container 1 can be easily taken out from the guide portion 4 by grasping the handle 69 by hand. Can be

A part of the vial holder 6 having the drug container 1 inserted therein is accommodated in the guide portion 4 together with the double-ended needle 3. The guide part 4 is integrally molded with the same synthetic resin as the vial holder 6 as a part of the solution container 2,
As shown in FIGS. 8 and 9, it has an open end as the upper end and a partition wall 48 as the lower end. An annular protrusion 49 for coupling with the cap 5 via the cap removing means 8 shown in FIG. 1 is formed in the vicinity of the open end side, and the inner wall of the guide portion 4 extends from the partition wall 48 toward the open end. A plurality of grooves running vertically are formed. The grooves are a plurality of longitudinal grooves 41 that run vertically to the vicinity of the open end (two axially symmetrical grooves are formed in FIGS. 8 and 9), and a plurality of double-ended needle engagement grooves 4 shorter than that.
4 (in the figure, four are formed in axial symmetry including the longitudinal groove 41. Illustration is omitted in FIG. 1). The longitudinal groove 41 is for engaging with the second engaging projection 62 of the vial holder 6 and lowering the vial holder 6 without rotating it. In this embodiment, the double-ended needle 3 is 4 as shown in FIG.
Since it has the book engaging arm 34, it also serves as the double-ended needle engaging groove 44. The double-ended needle engaging groove 44 may be provided with a step (not shown) for positioning the double-ended needle 3. Reference numeral 491 denotes a projection that engages with the locking projection 85 of the cap removing means 8 and has a function of preventing the cap removing means 8 from rotating counterclockwise.

The partition wall 48 has a communication port 46, which is formed in a concave shape in the center, for communicating with the dissolution liquid container. The communication port 46 has a thin film 47 at the bottom thereof as a closing film that can be pierced by the downward movement of the double-ended needle 3 (lower puncture needle 33 thereof) described later. The double-ended needle engaging groove 44 may also serve as the vertical running groove 41, or may be only two separately formed.

Further, when the cap removing means 8 is not provided, the annular projection 49 is unnecessary, and in this case, the open end of the guide portion 4 and the lower end of the skirt 55 of the cap 5 are respectively complemented with undercuts. And the cap 5 is fitted so as to be rotatable. The double-ended needle 3 used as the communication means is arranged between the drug container 1 and the solution container 2 as shown in FIG. 1, and is usually made of stainless steel (preferably SUS304) or synthetic resin canula and synthetic resin. It is composed of a resin hub. When the sharpness is important, stainless steel canula is preferable, but a synthetic resin double-headed needle is preferable in consideration of disposal problems and integral molding. A hard synthetic resin such as ABS resin or polycarbonate resin is suitable.

The double-ended needle 3 pierces the rubber stopper 12 of the mouth 11 of the medicine container 1 which has descended, and further descends together with the medicine container 1 to pierce the thin film 47 of the communication port 46 formed at the lower end of the guide portion 4. 3 to 5, the upper puncture needle 32 that pierces the hub 31 and the rubber stopper 12 of the drug container 1, and the communication port formed at the lower end of the guide portion 4 so as to be able to pass therethrough. Lower puncture needle 33 that pierces the thin film 47 of 46
The hub 31 is preferably provided with an engaging arm 34 that engages with the double-ended needle engaging groove 44 of the guide portion 4 and suppresses the downward movement of the double-ended needle 3. The engaging arm 34 is engaged with the double-ended needle engaging groove 44 at the protruding portion 341 at the tip thereof. The upper puncture needle 32 may be formed sharper than the lower puncture needle 33 so that the rubber stopper 12 of the drug container 1 can be pierced first. In the figure, the upper puncture needle 32 is formed at a sharp cutting edge in the central portion. Although the lower puncture needle 33 is formed on a beveled blade edge, the blade edge is not particularly limited to be formed. 36 is an outlet of the drug passage 35 on the side of the upper puncture needle 32, and although three outlets are formed in the figure, the number of outlets is not particularly limited.

The two drug passages 35 may be formed side by side. In this case, the drug solution can be moved without pressing the dissolving liquid container 2. The solution container 2 is generally a container that can be pressed and deformed and is made of a relatively soft synthetic resin such as polyethylene resin, polypropylene resin, or polyester resin, and the lower end of the guide portion 4 is integrally embedded in the upper part of the container. The lower end has a chemical solution outlet 23.

The chemical solution outlet 23 has the same structure as that of a normal bottle. For example, as shown in FIG. 1, the pressing member 25 and the rubber stopper 2 attached to the pressing member 25 are attached to the closing film 231 as shown in FIG.
A structure in which a sealing member consisting of 4 is covered is adopted. The sealing member is attached to the solution container 2 by welding a flange 232 formed on the outer wall of the chemical solution outlet 23 and a flange 251 formed on the pressing member 25. Although not shown, the rubber plug 24 of the sealing member may be protected by a cover member such as a film so that the surface thereof is not contaminated.

In the infusion container of the present invention, the lower end of the guide portion 4 is integrally embedded in the upper portion of the solution container 2, and the double-ended needle 3 and the mouth portion 11 side of the drug container 1 are set in the guide portion 4. Then, the cap 5 is airtightly attached to the open end of the guide portion 4 to complete the process. In this case, a sealing member such as a rubber cap that seals the lower puncture needle 33 of the double-ended needle 3 may be attached to the guide portion 4, and the cap removing means 8 may be used to connect the guide portion 4 and the cap 5. You may.

The cap 5 has a function of sealing the open end of the upper end of the guide portion 4 and moving the drug container 1 downward. Normally, as shown in FIG. 10 to FIG. The same synthetic resin is formed into a tubular shape. And, preferably, the hanging means 52 is provided on the top surface 57 of the cap 5.
And a seal member mounting groove 54 for accommodating a seal member 53 (see FIG. 1) that hermetically seals between the cap 5 and the guide portion 4 is formed at the lower end of the skirt 55 that is a side wall thereof. In addition, a spiral groove 51 that engages with the first coupling protrusion 61 of the vial holder 6 is formed on the inner wall of the skirt 55. The hanging means 52 may be provided with a hinge part 59 so that it can be folded. When the cap removing means 8 is adopted, a projection 56 that engages with the groove of the cap removing means 8 is provided at the lower end of the skirt 55. It may be provided. Incidentally, 58 is a suspension hole, and 561 is an arrow indicating the rotation direction.

The spiral groove 51 is provided longitudinally in a spiral shape on the inner wall of the skirt 55.
The first engaging protrusion 61, the second engaging protrusion 62, and the vertical groove 41 of the guide portion 4 constitute a medicine container pressing means. Although not shown, a spirally slanting protrusion may be used instead of the spiral groove 51. In this case, the first engaging protrusion 61 of the vial holder 6 may contact under the protrusion. Is located in. Further, as the drug container pressing means,
Although not shown, a protrusion corresponding to the first engaging protrusion 61 of the vial holder 6 is formed on the cap 5, and a spiral groove corresponding to the spiral groove 51 of the cap 5 and the second engaging protrusion are formed on the vial holder 6. 62 to form a combination with the vertical groove 41 of the guide portion 4, or a vertical groove corresponding to the first engaging protrusion 61 and the vertical groove 41 of the guide portion 4 is formed on the vial holder 6. It is also possible to adopt a structure in which a protrusion corresponding to the second engaging protrusion 62 of the vial holder 6 is formed and is combined with the spiral groove 51 of the cap 5.

The grooves referred to as the spiral groove 51 and the longitudinal groove 41 are
It also includes a trough formed between two protrusions as shown in the figure, and is not necessarily limited to the groove formed in the inner wall of the cap 5 or the guide portion 4. Further, as a method for connecting the cap 5 and the guide portion 4 by the cap removing means 8, for example, screwing, luer connection or any other suitable method of releasing the connection when the cap 5 is rotated in the opposite direction to the connection.

The cap removing means 8 removes the cap 5 from the guide portion 4 so that the drug container 1 and the double-ended needle 3 can be separated and disposed.
A ring-shaped member as shown in FIG. 4, which has an annular protrusion 81 that engages with the annular protrusion 48 of the guide portion 4 rotatably on the inner side, and a protrusion on the inner wall of the lower end of the cap 5 on the outer wall. A groove 82 that engages with 52 is formed. This groove 82
Are formed intermittently, and the portion of the groove break 83 is formed in the groove 82.
Is formed in a notched shape, that is, a step shape, and the length of the protrusion 52 of the cap 5 is shorter than the length of the cut 83 of the groove. A locking projection 84 is provided between the groove 82 facing clockwise and the groove 83, and when the cap 5 is rotated clockwise, the projection 52 collides with the locking projection 84 and the cap removing means 8 causes the cap removing means 8 to move. As it rotates with 5, the projection 52 of the cap 5 is in the groove 82 and then the cap 5
When is turned counterclockwise, the projection 52
Is coming to. In this case, since the protrusion 52 is formed shorter than the groove cut 83, when the cap 5 is moved upward when the protrusion 52 reaches the groove cut 83, the cap 5 is detached from the cap removing means 8.

Here, as shown in FIG. 1, the cap removing means 8 is almost covered with the lower end portion of the skirt 55 of the cap 5, so that it is impossible to rotate only the cap removing means 8 by hand. is there. Therefore, in order to prevent the cap removing means 8 from rotating together with the cap 5 when removing the cap 5, the inner wall of the upper end of the cap removing means 8 is engaged with the ridge 491 provided on the outer wall of the open end of the guide portion 4. Anti-rotation projections 85 are provided. And
When the cap 5 is rotated clockwise so that the drug container 1 and the solution container 2 communicate with each other so that the cap removing means 8 does not rotate when the cap 5 is rotated counterclockwise,
The ridges 491 of the guide portion 4 are designed to get over the rotation preventing projection 85.

14 to 15, the cap removing mechanism consisting of the groove 82, the groove cut 83 and the locking projection 84 is formed outside the cap removing means 8, but the cap removing mechanism is the cap removing means. 8 and may be combined with a protrusion (corresponding to the protrusion 52) formed on the outer wall of the lower end of the skirt 55 of the cap 5. Further, the cap removing mechanism may be provided on the inner wall or the outer wall of the cap 5 and may be combined with a similar protrusion provided on the outer wall or the inner wall of the cap removing means 8. However, when the cap removing mechanism or the protrusion is provided on the outer wall of the cap 5, the spiral groove 51 of the cap 5 and the first engaging protrusion 61 of the vial holder 6 are engaged with each other, so that the cap 5 is not used yet. Although it is not possible to rotate in the counterclockwise direction, the cap 5 can be removed by turning only the cap removing means 8 in the counterclockwise direction. Therefore, a separate means for preventing the cap 5 from being removed before use can be provided. It is necessary to provide.

FIG. 16 is a cross-sectional view of the essential parts of another embodiment of the present invention, in which a stand 9 is provided at the drug solution outlet 23 for making the infusion container self-supporting. 17 to 18, the stand 9 includes a leg portion 91 and a fitting portion 92, and the inner wall of the fitting portion 92 is fitted to the outer wall of the pressing member 25. The material of the stand 9 is not limited, but generally metal or synthetic resin is used. The infusion container of FIG. 1 can be made to stand upside down by folding the suspending means 52 of the cap 5, and can be made to stand by itself even if the lower end of the dissolving liquid container 2 is down.

Next, a method for using the infusion container of the present invention will be described in detail. When the cap 5 is rotated clockwise from the upper side, the vial holder 6 has its second engaging projection 62.
Since it is fitted in the longitudinal groove 41 of the guide portion 4, the rotation is blocked, while the first engaging projection 61 is attached to the cap 5
Since it is fitted in the spiral groove 51, it moves downward while sliding along the spiral groove 51 together with the drug container 1 held therein. Then, the vial holder 6 moves further downward together with the drug container 1 and the double-ended needle 3, and the upper puncture needle 32 of the double-ended needle 3 pierces the rubber stopper 12 of the drug container 1,
Next, the lower puncture needle 33 pierces the thin film 47 of the communication port 46 of the dissolution liquid container 2. When the drug container 1 and the dissolution liquid container 2 are thus communicated with each other via the double-ended needle 3, the dissolution liquid container 2 is then preferably turned up and is deformed. Thus, the dissolution liquid in the dissolution liquid container 2 flows into the medicine container 1,
A drug solution is obtained by mixing with the dry preparation in the drug container 1. Next, the solution container 2 is placed on the hanger (not shown) with the cap 5 facing upwards, and the solution container 2 is pumped to put the solution container 2 inside the drug container 1. By returning the drug solution and connecting an infusion set or the like to the drug solution outlet 23, infusion treatment can be performed.

When the infusion container is discarded after use, the cap 5 can be easily removed from the guide portion 4 by turning the cap removing means 8 counterclockwise from above. The double-ended needle 3 can be taken out and sorted and disposed. The double-ended needle may be configured as shown in FIGS. 19 to 21 so that the rubber stopper of the drug container can be inserted first by the double-ended needle and then the thin film portion of the guide portion of the dissolution liquid container can be inserted.

That is, the double-ended needle 303 is integrally formed of synthetic resin, and has an upper puncture needle 332 and a lower puncture needle 333.
And the hub 331 and the engaging arm 3 provided at the tip of this bub
34 and mainly. In addition, 335 is a protruding portion, 3
36 is a groove. Now, in FIG. 20, the drug container 301
In the state in which is moved downward along with the vial holder (not shown), the protruding portion 335 of the engaging arm 334 is locked to the step portion 337 of the guide portion 304. Therefore, when the drug container 301 moves further downward, the rubber plug (not shown) of the drug container 301 is first pierced by the upper puncture needle 332. Then, when the drug container 301 further moves down along with the vial holder (not shown), the drug container 301
311 pushes down the hub 331, whereby the protruding portion 335 of the engaging arm 334 moves away from the step 337, and the entire double-ended needle 303 is pushed down. Thus, the lower puncture needle 333 is formed in the lower end of the guide portion 304, and the communication port 3 is formed.
The thin film 347 of 46 is pierced and the drug in the drug container 301 and the solution in the solution container 302 are mixed.

A method for forming a solution container having the guide portion of the infusion container shown in FIG. 1 will be described below with reference to FIGS. First, in FIG. 22, parison 40 from die 401.
2, that is, a substantially cylindrical synthetic resin melt (polyethylene resin or polypropylene resin, 170 to 230 ° C.) is lowered (step 1), and the lower end of the parison 402 is pinched by the parison pinch 403 (step 2).

Next, in FIG. 23, air is blown into the parison 402 from the die 401 between the pair of main split molds 404 and 405 in a state where there is no lower mold and the parison 402 is expanded (step 3). Parison 402
Is sandwiched between a pair of main split molds 404 and 405 from the side, and the upper end portion of the parison 402 is cut (fused) by a heating blade (500 to 600 ° C., not shown) at the position of the arrow as shown in FIG. Step 4). The parison 402 is sandwiched by a pair of main split molds 404, 405 and moved laterally, and the mandrel 406 is lowered from the upper end opening formed by the cutting as shown in FIG. 25 to inflate and inflate the air (step 5).

Next, as shown in FIG. 26, the lower die 407 is set to 1
By raising and pressing between the pair of main split molds 404 and 405, the lower end of the pinched parison 402 is pushed up, and as shown in FIG.
The side molds 408 and 409 stored in the Nos. 4 and 405 are laterally moved (step 6). Then, as shown in FIG. 28, main split molds 404, 405, a lower mold 407, and a side mold 408,
By opening 409 and releasing the mold, the solution container 2 having the guide portion 4 can be obtained (step 7).

A communication port 4 formed at the lower end of the guide portion 4.
The thin film 47 of No. 6 has a gap (about 100 to 80) between the tip (lower end) of the mandrel 406 and the tip (upper end) of the lower mold 407.
0 μm). The annular protrusion 49 of the guide portion 4 is substantially formed by the side molds 408 and 409. Note that 410 in FIG. 26 and 411 and 41 in FIG.
2 is a cylinder.

[0041]

As described above, by adopting the infusion container of the present invention, the mixing operation is easy and labor-free,
It is possible to provide an infusion container capable of aseptically mixing a drug and a solution without the risk of the mixed drug solution leaking. Further, in the present invention, since the lower end portion of the guide portion is embedded in the dissolution liquid container, the total length of the infusion container (the length in the connecting direction between the drug container and the dissolution liquid container) can be shortened. This facilitates storage in hospitals and the like, and also provides compactness suitable for transportation.

Further, since a complicated structure for connecting the capsule and the solution container can be omitted and the number of parts can be reduced, the infusion container can be provided at a low cost.

[Brief description of drawings]

FIG. 1 is a sectional view of an essential part of an embodiment of an infusion container of the present invention.

FIG. 2 is a cross-sectional view of main parts of the drug container of FIG.

3 is a cross-sectional view of the double-ended needle of FIG.

FIG. 4 is a bottom view of FIG.

FIG. 5 is a plan view of FIG.

6 is a cross-sectional view of the vial holder of FIG.

FIG. 7 is a bottom view of FIG.

8 is a cross-sectional view of the guide portion of FIG.

9 is a plan view of FIG. 8. FIG.

10 is a side view of the cap of FIG. 1. FIG.

11 is a sectional view taken along line XX of FIG.

12 is a bottom view of FIG.

13 is a plan view of FIG.

FIG. 14 is a plan view of the cap removing means.

15 is a sectional view taken along line XX of FIG.

FIG. 16 is a sectional view of an essential part of another embodiment.

17 is a cross-sectional view of the stand of FIG.

FIG. 18 is a bottom view of FIG.

FIG. 19 is a plan view showing another embodiment of the double-ended needle and the engaging arm.

20 is an explanatory diagram for explaining the operation of the double-ended needle and the engaging arm of FIG.

FIG. 21 is a view corresponding to FIG. 20 showing a different state.

22 is an explanatory diagram illustrating a method of manufacturing the dissolution liquid container in FIG. 1. FIG.

FIG. 23 is a view corresponding to FIG. 22 showing a different state.

FIG. 24 is a view corresponding to FIG. 22 showing a different state.

FIG. 25 is a view corresponding to FIG. 22 showing a different state.

FIG. 26 is a view corresponding to FIG. 22 showing a different state.

FIG. 27 is a view corresponding to FIG. 22 showing a different state.

FIG. 28 is a view corresponding to FIG. 22 showing a different state.

FIG. 29 is a view corresponding to FIG. 1 showing a conventional example.

[Explanation of symbols]

 1 drug container 2 dissolution liquid container 3 double-headed needle 4 guide part 5 cap 6 vial holder 8 cap removing means 23 drug solution outlet 32 upper puncture needle 33 lower puncture needle 41 vertical running groove 46 communication port 47 thin film 51 spiral groove 61 first relation Mating protrusion 62 Second engaging protrusion 69 Handle

─────────────────────────────────────────────────── ─── Continuation of the front page (51) Int.Cl. ⁶ Identification code Internal reference number FI technical display location // B29C 49/04 7619-4F 49/20 7619-4F (72) Inventor Jun Futagawa Osaka, Osaka 3-9-3 Honjo-nishi, Kita-ku, Nissho Co., Ltd. (72) Inventor Tetsuji Miyamoto, 3-9-3 Honjo-nishi, Kita-ku, Osaka-shi, Nissho (72) Inventor Mitsuo Murakami Osaka, Osaka Nissho Co., Ltd. 3-9-3 Honjo Nishi, Kita-ku, Japan

Claims (10)

[Claims] 1. A drug container whose mouth is sealed with a pierceable stopper, and a vial holder for holding the drug container therein,
Pressing having a drug solution outlet and a communication port for a drug container closed in a liquid tight manner with a thin film at both ends thereof and surrounding said communication port and being provided with a cylindrical guide portion concentrically therewith. A deformable synthetic resin solution container and a double-ended needle that is vertically slidably accommodated in a guide portion of the solution container,
And a cap for accommodating the vial holder and rotatably sealing the opening of the guide part, and further for cooperating with the inner wall of the cap, the inner wall of the guide part and the outer wall of the vial holder to move the drug container downward. By providing a container pressing means, the vial holder moves downward without rotating when the cap is rotated to reach the double-ended needle, and further moves downward together with the double-ended needle, whereby the drug container held in the vial holder An infusion container, wherein the stopper at the mouth and the thin film at the communication port of the dissolution liquid container are pierced by a double-ended needle to allow communication between the drug container and the dissolution liquid container. 2. The infusion container according to claim 1, wherein a lower end portion of the guide portion is embedded in the dissolution liquid container, and a communication port is formed at the lower end portion. 3. The medicine container pressing means comprises a plurality of parallel spiral grooves provided obliquely downward in the inner wall of the cap, a plurality of vertically extending grooves provided in the inner wall of the guide portion, and a vial holder. A plurality of first engaging projections provided in the vicinity of the upper end of the outer wall of the vial and slidably fitted in the spiral groove, and in the vertical groove provided in the vicinity of the lower end of the outer wall of the vial holder. The infusion container according to claim 1 or 2, comprising a plurality of second engaging protrusions movably fitted therein. 4. The medicine container pressing means comprises a plurality of parallel spiral protrusions provided on the inner wall of the cap and obliquely running downward, a plurality of vertically extending protrusions provided on the inner wall of the guide portion, and a vial. A plurality of first protrusions provided near the upper end of the outer wall of the holder and slidably fitted with the spiral protrusions.
3. The infusion solution according to claim 1 or 2, comprising a plurality of second engaging grooves which are provided in proximity to the lower end portion of the outer wall of the vial holder and slidably fitted in the vertically extending projections. Container. 5. The infusion container according to any one of claims 1 to 4, wherein the cap comprises a suspending means. 6. The infusion container according to claim 1, wherein the guide portion is provided with a cap removing means. 7. The infusion container according to claim 1, wherein the vial holder is provided with a handle for taking out the drug container on the top surface thereof. 8. The transfusion container according to claim 1, wherein the double-ended needle pierces the stopper of the mouth of the drug container first and then the thin film of the communication port of the solution container. 9. A synthetic resin parison introduced into a split mold is blown, then the blowing opening is cut, a lower mold is pressed and set on the bottom side of the parison, and the mandrel is pushed from the blowing opening side. Insert and blow
By releasing the mold, it has a communication port between the drug solution outlet and the drug container closed with a thin film at both ends thereof, and a cylindrical guide portion is provided concentrically with the communication port so as to surround the communication port. A method for manufacturing a dissolution liquid container, which obtains a dissolution liquid container made of a synthetic resin that can be deformed by pressing. 10. The manufacturing method according to claim 9, wherein the lower end portion of the guide portion is embedded in the dissolution liquid container, and a communication port is formed at the lower end portion.