JPH07255820A - Infusion solution vessel - Google Patents

Abstract

PURPOSE:To provide an infusion solution vessel by which a medicine and dissolving liquid can be simply mixed together in a sterile condition with the small number of part items by adding an air bleeding plug to a medicine vessel housing part. CONSTITUTION:An infusion solution vessel has a synthetic resin dissolving liquid vessel l with a discharge port plug 2 in a lower part by blow molding and a communicating member holding part 6 above it so as to hold a communicating member 3 whose needle part 4 can downward slide in an outer cylinder 5 by press from above, and has a bellows part 7 capable of compressive deformation in the axis direction above the holding part and a bellows fixing member 8 in the outer peripheral part so so to freely separate from each other, and has an upper end sealed shape cylinder part 9 above it so as to hold a medicine vessel 10, a thin part on the outer periphery of a cylinder part, an air bleeding twist-off plug 12 on the upper end of the cylinder part and a hanging tool 13.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention uses blow molding to form a connecting member holding portion for holding a connecting member and a bellows portion between a synthetic resin solution container with a discharge spout and a cylindrical portion for holding a drug container. A detachable bellows fixing member, and an infusion container integrally formed with an air venting twist-off plug and a suspender at the upper end of the tubular portion.

[0002]

2. Description of the Related Art Heretofore, an infusion container of this kind has a tube in which a capsule containing a drug container and a flexible container containing a solution are joined, and the flexible container and the flexible container are connected to each other by a communicating means provided in the tube. There is Japanese Patent Publication No. 61-501129 in which a drug and a solution are mixed by communicating with a sex container.

Further, there is provided a storage chamber in which a solvent is enclosed inside a drug container having a discharge port, and a solute container having a piercing portion which contains a solute dissolved by the solvent and which can be pierced by a piercing needle. , A piercing needle that is interposed between the storage chamber and the solute container and that can pierce the piercing portion of the solute container when necessary, and can be separated when necessary in the storage chamber. The communication part, which is composed of the closed part that is in the communication state, and the piercing part of the solute container and the piercing needle are connected at a predetermined interval, and when an external force of a predetermined amount or more is applied, plastic deformation is performed in the axial direction of the piercing needle. Japanese Patent Publication No. 2-36261 which connects the storage chamber and the solute container by inserting a piercing needle into the piercing part of the solute container and separating the separable closed part. There is.

Further, a dissolving or diluting solution is stored inside, the capsule is connected to a flexible container having a fluid passage portion whose upper end is closed by a closing membrane, and a mouth is sealed with a pierceable stopper. Holding the drug container in the capsule, the communication means for communicating the inside of the flexible container and the drug container, has a hub in the middle, a hollow puncture needle having a cutting edge at both ends,
A means for controlling the order of communication is provided so that the stopper of the drug container is pierced by one blade of the puncture needle and then the flexible container closing film is pierced by the other blade of the puncture needle.
There is 1277 publication.

Furthermore, a bag for solution encapsulation having a neck portion sealed by a soft plug body at the upper portion and a port for connecting an infusion set formed at the lower portion, and a tubular shape for connecting to the bag through the neck portion. A case, a holder with a bottomed cylindrical bellows that accommodates the vial and is slidably inserted into the case, and a hollow that is held so that both ends face the mouth and stopper of the vial. The bellows has a needle and a closed space including a hollow needle and a vial is formed on an upper part of a bag stopper, and the hollow needle pushes a holder into a case, the vial stopper and the bag are closed. Japanese Unexamined Patent Publication (Kokai) No. 4-1 to pierce both the stopper and the vial to communicate with the bag.
There is a publication of 56849.

Further, in a medical container in which a dissolution liquid storage container and a drug container storage container are connected, it is divided into two chambers by a separable partition part, the dissolution liquid is stored in the first chamber, and the second chamber is a space part. A flexible plastic storage container, and a cylindrical plastic with a flange for connecting the dissolution storage container at the bottom end, a bellows part on the body, and a cap for holding the drug container on the top end A container for a drug container is provided at the upper part of the second chamber of the solution container, the mouth of which is fitted with a rubber plug into which a piercing needle is inserted. Japanese Patent Laid-Open No. 4-221567 in which the bellows portion is releasably adhered.

[0007]

[Problems to be Solved by the Invention] Conventional Patent Publication 61-5
In Japanese Patent No. 01129, there is a problem in that it is necessary to fold the breaking member by hand to open the passage after piercing the rubber stopper of the vial with the puncture needle, which takes time to dissolve the drug with the dissolution liquid. It was

When the breaking member is manually broken, if the breaking is incomplete, it is difficult for the solution to pass through the passage, and it takes time to dissolve the drug.

There is also a problem that when the breaking member is manually broken and separated, fine particles of synthetic resin of the material are generated.

Further, since the capsule containing the drug container and the flexible container containing the solution are joined by a tube, the drug container cannot be easily taken out from the drug container storage container. Cannot separate and dispose of containers.

Next, in Japanese Patent Publication No. 2-36261, after the rubber stopper of the vial is pierced with a puncture needle, the breaking member must be broken by hand to open the passage, and the drug is dissolved in the solution. There was a problem that it took time and effort.

When the breaking member is manually broken, if the breaking is incomplete, it is difficult for the solution to pass through the passage, and it takes time to dissolve the drug.

Further, there is a problem that when the breaking member is broken by hand and separated, fine particles of synthetic resin of the material are generated.

Since the storage chamber (solvent container) in which the solvent is enclosed and the solute container (medicine container) containing the solute to be dissolved by the solvent are not fixed, it is easy to bend or break near the communicating portion, It has the drawback that it requires careful handling and is inconvenient.

When the medicine container is pressed, the medicine container is not provided with an air vent, so that the medicine container,
The air between the dissolution liquid container and the drug storage container is compressed, and the compressed air repels, so that the drug storage container cannot be sufficiently pressed.

Further, in Japanese Patent Laid-Open No. 2-1277, the inside of the drug container can be moved up and down by rotating the cap of the drug container container (capsule) that houses the drug container. Cannot be maintained until the end of the dissolution operation, and there is a problem that cannot be called aseptic operation.

Further, since a hollow puncture needle (double-ended needle) having a hub in the middle and blades at both ends is used to pierce two rubber stoppers of a solution container and a drug container, the center of the hole of the rubber stopper is pierced. There is a drawback that coring that does not match is likely to occur.

Since the drug container cannot be easily taken out from the drug container storage container, the drug container storage container and the drug container cannot be separated and discarded.

Further, the capsule is connected to a flexible container having a fluid passage portion whose uppermost end is closed by a closing membrane, and a drug container whose mouth portion is sealed with a pierceable stopper is held in the capsule to provide flexibility. A hub is provided between the inside of the container and the inside of the drug container in the middle, and they are communicated with each other by a hollow puncture needle having blade tips at both ends, and after the stopper of the drug container is pierced by one blade of the puncture needle,
Since the flexible container closing membrane is pierced by the other blade of the puncture needle, it comprises a control means for the communication sequence, so that there is a drawback that the overall structure becomes complicated.

Further, in Japanese Patent Application Laid-Open No. 4-156849,
A cylindrical case that connects to the bag via the neck part, a holder with a bottomed cylindrical bellows that houses the vial and is slidably inserted into the case, and there is no air vent in the cap When the drug container is pressed, there is a disadvantage that compressed air does not escape and a large force is required to press the drug container.

Further, since the drug container (vial bottle) cannot be easily taken out from the drug container storage container (a holder and a cap having a bottomed cylindrical bellows), the drug container storage container and the drug container cannot be separately discarded.

A bag for solution encapsulation having a neck portion sealed by a soft stopper at the upper portion and a port for connecting an infusion set formed at the lower portion, and a tubular portion connected to the bag through the neck portion. A case, a holder with a bottomed cylindrical bellows that accommodates the vial and is slidably inserted into the case, and a hollow that is held so that both ends face the mouth and stopper of the vial. Since it is provided with a needle, there is a drawback that the overall structure is complicated.

Further, in Japanese Patent Laid-Open No. 4-221567, in order to prevent the solution from flowing back through the communicating portion,
It is necessary to divide the dissolution liquid storage container into two chambers by a partition part that can be peeled off.

Further, when the drug container is pressed, there is a disadvantage that compressed air does not escape because the cap and the bellows are not provided with air vents, and a large force is required to press the drug container.

Further, since the drug container cannot be easily taken out from the drug container storage container, the drug container storage container and the drug container cannot be separated and discarded.

Further, a partitioning portion which can be peeled off is divided into two chambers to store the dissolving liquid in the first chamber, and the second chamber is a space for the dissolving liquid storage container made of flexible plastic, and the dissolving liquid is placed at the bottom end. A flange for connecting with the liquid storage container is formed, and a bellows portion is formed on the body, and a cylindrical plastic drug container storage container is attached to the upper end with a cap for holding the drug container,
At the upper part of the second chamber of the dissolution liquid storage container, there is provided a mouth part into which a rubber plug having a piercing needle inserted in the center part is fitted, and the cap of the medicine container storage container and the bellows part are detachably bonded to this mouth part ,
There is a drawback that the overall structure is complicated.

The present invention has been made in view of the problems and drawbacks of the prior art described above. An air bleeding stopper is attached to a drug container storage portion by blow molding, and the drug and the solution can be easily dissolved with a small number of parts. It is an object of the present invention to provide an infusion container capable of aseptic mixing.

[0028]

SUMMARY OF THE INVENTION In order to achieve the above object, the present invention provides a synthetic resin solution container with a discharge spout downward by blow molding and a needle by pressing the solution solution container upward from above. A communication member holding portion that holds a communication member whose portion is slidable downward with respect to the outer cylinder portion is provided.

A bellows portion that can be axially compressed and deformed above the communicating member holding portion, a separable bellows fixing member that fixes the bellows portion to the outer peripheral portion of the bellows portion, and a drug above the bellows portion. An upper end sealed cylindrical portion that holds the container and a thin-walled portion that can be cut off are provided on the outer circumference of the cylindrical portion.

An air bleeding twist-off plug and a suspender are provided on the upper end of the tubular portion.

[0031]

Operation: A synthetic resin solution container 1 with a discharge plug 2 by blow molding, sealing of the discharge plug 2 and a solution 1a
, A communication member holding portion 6 into which the communication member 3 is inserted, a bellows portion 7, a separable bellows fixing member 8 for fixing the bellows portion 7, an upper end sealed cylindrical portion 9 for holding the drug container 10, Since the air vent twist-off plug 12 and the hanger 13 are integrally molded, it is possible to easily and aseptically manufacture an infusion container with a small number of parts.

A twist-off plug 1 for venting air is provided at the upper end of the tubular portion 9.
Since 2 is provided, even if the upper end of the tubular portion 9 is pressed downward by opening the twist-off plug 12, the air in the bellows portion 7 escapes from the gap between the tubular portion 9 and the drug container 10 to the outside easily. Communication between the drug container 10 and the dissolution liquid container 1 by the communication member 3 becomes possible.

Since the thin portion 11 which can be separated is provided in the tubular portion 9 for holding the chemical liquid container 10, the thin portion 11 is used after use.
To separate the upper part of the tubular part 9 from the lower part,
By taking out 0, the drug container 10 and the solution container 1 can be separated and discarded.

[0034]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a front view of the infusion container of the present invention, FIG. 2 is a two-part view at the center in a plane parallel to the paper surface, and FIG. 3 is a view of removing the bellows fixing member and pressing the drug container. Then, the needle portion of the communication member is inserted into the rubber stopper of the drug container, and FIGS. 4 to 10 show stepwise steps of blow molding of the infusion container of the present invention.

As shown in FIG. 1, reference numeral 1 denotes a blow-molded synthetic resin solution container, which is a mold 1 for molding the solution container.
A thermoplastic synthetic resin is extruded into a tube shape between the four and fourteen, and a vacuum plug is sucked from the lower parts of the molds and 14 to the tip of the insertion rod 15 as a discharge plug 2 to synthesize only the rubber plug 2a or the rubber plug 2a. The resin-made plug 2b is fitted and inserted, and the molds 14 and 14 in which the fitting annular grooves 14a and 14a of the discharge plug 2 are molded are closed, and the bottom of the tubular synthetic resin 16 is closed, Dissolving liquid container 1, that is, neck portion 1 of molds 14,14
Blower / filling nozzle 18 descends to 7, 17 and mold 1
Compressed air is blown into the tubular synthetic resin 16 in the molds 4 and 14 for molding, and then the solution 1a is filled.

Here, reference numeral 19 is a cover for covering the lower portion of the discharge spout 2 formed at the bottom of the solution container 1, which closes the dies 20, 20 for molding the bottom of the tubular synthetic resin 16, and the bottom thereof. As shown in FIG. 1, it is molded and sealed in a slightly wide protrusion.

Reference numeral 3 denotes a communication member in which the needle portion 4 is airtightly fitted in the outer cylinder portion 5, and the tip end portion of the needle portion 4 is a small diameter portion 4a and the base portion is an insertion fitting portion 4b which is fitted in the outer cylinder portion 5. The communication holes 3a, 3a are provided from the tip of the small-diameter portion 4a to the base of the insertion portion 4b, and the communication holes 3b, 3b are formed from the outer peripheral surface of the base of the insertion portion 4b to communicate with the communication holes 3a, 3a. is there.

That is, the insertion hole 4b of the needle portion 4 inserted into the outer cylinder portion 5 and the small diameter portion 4a of the needle portion 4 communicate with each other through the communication hole 3
a, 3a communicate with the communication holes 3b, 3b, communicate with the outer peripheral base of the needle portion 4 and the tip of the needle portion 4, and when the needle portion 4 is slid downward in the outer cylindrical portion 5, protrudes from the outer cylindrical portion 5. The solution container 1 at the base of the needle 4 and the drug container 10 described later at the tip of the needle 4 are communicated with each other.

Reference numeral 6 denotes a communicating member holding portion for holding the outer cylindrical portion 5 of the communicating member 3, which is formed on the upper end of the dissolving liquid container 1.
As shown in FIG. 7, the insertion portion 4b in the middle of the needle portion 4 of the communicating member 3 is vacuum-sucked into the tubular synthetic resin 16 by the insertion rod 21 to change to the blowing / filling nozzle 17 and the upper end of the solution container 1. The molds 22 and 22 which are inserted into the part and mold the communication member holding part 6 and the bellows part 7 at the upper end to be described later are closed and blow-molded.

Reference numerals 6a and 6a denote reinforcing portions formed from the upper end of the dissolving liquid container 1 to the lower portion of the communicating member holding portion 6, and the molds 14 and 14 at the portions are formed with recesses to blow the dissolving liquid container 1. It was molded at the time of molding.

Reference numeral 7 denotes a bellows portion, which is formed above the communicating member holding portion 6 by being connected to the holding portion 6 and is capable of being compressed and deformed in the axial direction. 22 and 22 are blow-molded.

Numerals 8 and 8 are bellows fixing members, which are formed in a flash shape so as to be separated from each other on the outer peripheral side of the bellows portion 7 between the communicating member holding portion 6 and an upper end sealed cylindrical portion 9 which will be described later. Molds 22 and 22 for molding the communicating member holding portion 6 and the bellows portion 7 together
A slight recess is formed on the surface of the bellows, and the bellows portion 7 is formed by blow molding.

Reference numeral 9 denotes an upper end hermetically sealed cylindrical portion, which is contained in a tubular synthetic resin 16 above the bellows portion 7 in a drug container 1 such as a vial.
0 is inserted with the rubber plug 10a facing downward, and the molds 23, 23 having the shape of the drug container 10 in a half-divided shape are closed and molded.

Here, the drug container 10 is a well-known glass or plastic vial bottle, which is aseptically sealed with a rubber stopper 10a, and a powder formulation, a lyophilized formulation, a solid formulation or the like is used therein. A soluble drug (not shown) is contained.

The material of the rubber stoppers 2a and 10a is not particularly limited as long as it does not affect the quality of the contained drug and prevents the invasion of microorganisms. It is preferably compatible with the rubber stopper test method, and may be coated or laminated with a material such as plastic.

The thermoplastic synthetic resin used in the infusion container of the present invention is not particularly limited as long as it can be blow molded, but generally polyethylene, polypropylene, polyvinyl chloride, polyester, etc. can be used. .

Further, the needle portion 4 is formed of synthetic resin and has a hardness capable of piercing the rubber stopper 10a.

Reference numeral 11 denotes a thin-walled portion formed from the outer peripheral surface at the lower portion of the upper end sealed tubular portion 9, and the upper end sealed tubular portion 9 is molded by the V-shaped projections 24, 24 formed at the lower portions of the molds 23, 23. It is molded at the time, and it is used as an infusion container and is used after
The upper and lower parts are separated.

Numeral 12 is a twist-off plug for air bleeding formed on the upper end of the central portion of the sealed end of the upper end sealed cylindrical portion 9, which is the mold 2
3, 23 is formed in the upper end of the center of the cavity in the shape of the half-divided medicine container 10 and a slight inclined surface 25, 25 is formed, and small recesses 26, 26 are provided. The mold projections 27, 27 are molded and molded at the time of molding the upper end sealed cylindrical portion 9, and the plug 12 is formed by the V-shaped projection 2
The air vent holes 12a are exposed by twisting with the separable cuts 27a, 27a formed by 7, 27.

Reference numeral 13 denotes a suspender, which is a ring-shaped member above both sides of the sealed end of the upper end sealed cylindrical portion 9. The upper end sealed cylindrical portion is formed by the recesses 28 and 28 provided above both upper ends of the cavity. It was molded at the time of molding 9, and is hung on a hanger or the like.

In using this, first, the bellows fixing members 8 on both outer peripheral sides of the bellows portion 7 are separated from the bellows portion 7 by separating, and then the air venting twist formed on the upper end of the central portion of the sealing end of the tubular portion 9. Open the off plug 12.

The bellows portion 7 is compressed and deformed by pushing down the tubular portion 9 to pierce the needle portion 4 of the communicating member 3 into the rubber stopper 10a of the drug container (vial bottle) 10 and the inside of the outer tubular portion 5 inside. Slide down.

The dissolution liquid 1a in the dissolution liquid container 1 is connected to the communication member 3
To dissolve into the medicine container 10 and to dissolve the medicine, and to cut off the cover 19 provided on the discharge port stopper 2 of the solution container 1.
Open the mouth plug 2.

The suspending tool 13 is hung on a hanger or the like, a dosing device such as a needle or a tube is attached, and a drip is administered as an infusion.

[0056]

According to the present invention, the synthetic resin solution container 1 with the discharge plug 2 by the blow molding, the discharge plug 2 is hermetically sealed, the communication member holding portion 6, the bellows portion 7, and the detachable bellows fixing. Since the member 8, the tubular portion 9 for holding the medicine container 10, the air vent twist-off plug 12, and the hanger 13 are integrally molded, it is possible to easily mix aseptic medicine and solution with a small number of parts. The container can be manufactured inexpensively.

A twist-off plug 1 for bleeding air is provided at the upper end of the tubular portion 9.
Since 2 is provided, when pushing down the upper portion of the tubular portion 9,
Since the air can be released and the air is not compressed, the needle portion 4 of the communication member 3 can be easily inserted into the rubber stopper 10a of the drug container 10.

Since the thin portion 11 which can be detached is provided in the tubular portion 9 for holding the drug container 10, the drug container 1 is used after infusion.
0 and the dissolution liquid container 1 can be separated and discarded, and the waste treatment becomes easy.

Further, according to the present invention, by sliding the communication member 3, the dissolution liquid container 1 and the drug container 10 can be communicated with each other, and since the breaking member is not broken by hand unlike the conventional case, it is troublesome. In addition, fine particles of synthetic resin are not generated.

[Brief description of drawings]

FIG. 1 is a front view of an infusion container of the present invention.

FIG. 2 is a central vertical cross-sectional view of FIG. 1 taken along a plane parallel to the paper surface.

FIG. 3 is a view of FIG. 1 when the bellows fixing member is removed, the drug container is pressed, and the needle portion of the communication member is inserted into the rubber stopper of the drug container;
It is an A line sectional view.

FIG. 4 shows a step of blow molding of the infusion container of the present invention, and is an end view in which the center of the tubular synthetic resin with the outlet plug inserted is cut vertically.

FIG. 5 is a cross-sectional end view showing the process of blow molding of the infusion solution container of the present invention, in which the center of the solution container molding die is vertically cut.

FIG. 6 shows the steps of blow molding of the infusion solution container of the present invention, in which the bottom of the dissolution solution container is sealed and blown into the neck.
It is an end view which cut | disconnected the center of the state which inserted the filling nozzle and was filled with the solution after blow molding.

FIG. 7 is a longitudinal sectional view of the center of the infusion solution container of the present invention during blow molding, in which the communication member is inserted above the dissolution liquid container.

FIG. 8 is a cross-sectional end view showing the process of blow molding the infusion container of the present invention, showing a state at the time of molding the communication member holding portion and the bellows portion, with the center vertically cut.

FIG. 9 is a side view of the process of blow molding of the infusion container of the present invention, in which the center of the tube-shaped synthetic resin with the drug container inserted therein is vertically cut.

FIG. 10 is a view showing a process of blow molding the infusion container of the present invention, showing an upper end sealed cylindrical portion, an air bleeding twist-off plug, and a state when molding a slinging device. Is.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Synthetic resin dissolution liquid container 1a Dissolution liquid 2 Discharge mouth plug 2a Rubber stopper 2b Synthetic resin mouth plug 3 Communication member 3a, 3b Communication hole 4 Needle part 4a Small diameter part 4b Insertion part 5 Outer cylinder part 6 Communication member Retaining part 6a Reinforcing part 7 Bellows part 8 Bellows fixing member 9 Upper end sealed cylindrical part 10 Drug container 10a Rubber stopper 11 Thin wall part 12 Air vent twist off plug 12a Air vent hole 13 Lifting tool 14 Melting liquid container molding die 14a For fitting Annular hole 15 Insert rod 16 Tubular synthetic resin 17 Dissolution container neck 18 Blow / fill nozzle 19 Discharge spout cover 20 Bottom molding die 21 Insert rod 22 Communication member holding part and bellows molding die 23 Top end sealing Shaped cylindrical part molding die 24 V-shaped protruding portion 25 Sloping surface 26 Recessed portion 27 V-shaped protruding portion 27a Break 28 Recessed portion

Claims (1)

[Claims] 1. A blow-molded synthetic resin solution container with a discharge plug downward, and a communication in which a needle part is slidable downward with respect to an outer cylinder part by pressing from above the solution container. A communicating member holding portion that holds the member, a bellows portion that can be axially compressed and deformed above the communicating member holding portion, and a separable bellows fixing member that fixes the bellows portion to an outer peripheral portion of the bellows portion. An upper end sealed tubular portion for holding the drug container above the bellows portion, a thin-walled portion that is separable around the outer periphery of the tubular portion, and an air bleeding twist-off plug and a suspender are integrally provided on the upper end of the tubular portion. Infusion container characterized by.