WO1989002730A1

WO1989002730A1 - Separate storage container

Info

Publication number: WO1989002730A1
Application number: PCT/JP1988/000980
Authority: WO
Inventors: Norisuke Kira; Kazuhiko Sudo
Original assignee: Terumo Kabushiki Kaisha
Priority date: 1987-09-28
Filing date: 1988-09-27
Publication date: 1989-04-06
Also published as: DE3850781D1; EP0395758A4; JPH0236261B2; JPS6485653A; DE3850781T2; EP0395758B1; EP0395758A1

Abstract

A communication section (9) has a piercing needle (8) capable of piercing through a piercing section (11) of a solute container (10) storing therein a solute such as a drug, and a closing section (7) which is separable inside a storage chamber (2) storing therein a solvent. The communication section (9) is disposed between the solute container and the storage chamber, and a bellows-like guide cover (12) covers the piercing needle. Accordingly, the piercing needle is positively kept separated from the piercing section when not in use and the guide cover undergoes plastic deformation under an external force exceeding a predetermined value when in use, thereby permitting the piercing operation to be initiated and then maintained. Due to the subsequent separation of the closing section, the solute and the solvent are mixed through the communication section and sterile dissolution can be ensured.

Description

'Specification

Separation container

Technical field

The present invention relates to a container for separating and storing two or more substances, and more particularly, to a method for dissolving a solute in a storage chamber in a solute storage member storing a solute such as a powdery or liquid drug. The present invention relates to a separation container in which a solvent such as a liquid can be sent, and a solute such as a powdery or liquid drug can be mixed and dissolved aseptically. Background technology ''

Many solute drugs are dissolved in a solvent dissolution medium just before being injected intravenously into a patient. There are many reasons for this, but the typical one is that once a drug is dissolved in a lysis solution, its effectiveness can only be maintained for a short period of time. For this reason, when administering powdered drugs such as antibiotics conventionally contained in a solute container forming a solute container village to a patient, the following method is used in conventional methods. Methods were generally adopted.

First, in the first example, an appropriate amount of a physiological saline solution, a 5% glucose injection solution or the like is sucked with a syringe, and the powdered drug is contained in the solute container. Then, the needle of the syringe was pierced, the lysing solution was injected, and after the powdered drug was dissolved, the patient was again sucked with the syringe and injected into the patient.

A second example is containing a powdered drug, as disclosed in, for example, Japanese Patent Publication No. 59-500600 The solute container and the bag enclosing the dissolving solution are aseptically connected by an adapter forming a communicating means holding the piercing needle and the breakage portion, and the dissolving solution is stored with the powdered drug. The drug solution was injected into the solute container, and the powdered drug was dissolved. This solution was returned to the bag again, and the patient was infused intravenously.

In addition, here, a sleeve formed of a flexible material that is arranged so as to surround the piercing needle and that expands and contracts in response to the movement of the needle is shown. .

Further, as a third example, a solute vessel containing a powdered drug and a lysing solution, as disclosed, for example, in U.S. Pat. No. 4,844,920. And an assembling bag, which are aseptically connected to each other by a needle or an adabuta having a broken part, and the lysing solution is put into the solute container. Dissolve the powdered drug, then use the empty bag as an air vent to completely dissolve the antibiotics, etc., return the solution back to the bag, and inject the solution intravenously into the patient. Was.

Also here, as in the second example, a flexible and stretchable sleeve or boot surrounding the piercing needle is shown.

However, the above-mentioned conventional example still has various problems to be solved. That is, in the case of the first example, the solution, the syringe, and the container containing the powdered drug are separately prepared, and these operations are performed in a facility such as a clean bench capable of performing aseptic work. Operation complexity, There is also a risk of bacterial contamination. In the case of the second example above, although a sterile facility such as a clean bench is not required, the piercing portion provided in the solute container containing the powdered drug and the piercing needle on the adapter are not required. The solute container and the adapter are connected incorrectly, or the operator is required when necessary, because there is no means to positively maintain the separated state during normal non-use. However, there are problems such as the complicated connection operation and the complicated structure of the adapter.

Also, in the case of the third example, similarly to the second example, the piercing portion provided on the solute container and the piercing needle on the adapter are actively separated when not in use. There was a danger of accidentally piercing the connection between the solute container and the adabuta, because there was no means to maintain the condition. Further, in the case S of this example, the liquid in which the powdered drug is dissolved enters the empty bag during the use operation, and the liquid is returned to the bag containing the dissolved liquid again. However, there were problems such as the difficulty of

Therefore, the present invention solves the above-mentioned problems of the conventional separation and storage container, and has a simple structure. The piercing section of one of the two receiving members and the piercing element that can pierce the piercing element when necessary are actively kept apart from each other, and the piercing section is operated when used. The user easily and reliably performs the above-described piercing operation, and aseptically connects the chamber of one of the storage members and the chamber of the other storage member that contains the other substance to perform the required mixing (dissolution). An object of the present invention is to provide a medicine container which can perform an action and is easy to operate.

Disclosure of the invention

In order to achieve the above object, in the present invention, a common configuration disclosed in the above-described second and third conventional examples is taken as a starting point. ·

That is, a first housing member having an outlet and a first chamber in which a first substance is accommodated, and a second accommodation member which accommodates a second substance and has a piercing portion. A stimulating element that allows the piercing portion of the second housing member to pierce with a predetermined piercing resistance when necessary, and a piercing element that extends into the first chamber, and A closing portion that closes communication between the first chamber and the piercing element and is separable when required, and has a closing portion that allows the communication to be performed when the first chamber is separated; It is assumed that there is a communication means' for aseptically communicating between the first chamber and the second chamber, and a further configuration.

With respect to the above-described configuration, the present invention provides a method for controlling the communication between a second housing member and a first chamber, wherein the second housing member surrounds the stimulating element and is always pierced by the second housing member. The piercing element and the piercing element are held in the chick state, and when an external force of a predetermined value or more along the axial direction of the piercing element is applied, the piercing element is plastically deformed along the axial direction. Then, the piercing part is allowed to pierce the piercing element and the holding means for maintaining the piercing state is provided, and the piercing element is stimulated by the piercing element. It has been made Later, by separating the closing part of the communication means, aseptic communication between the first chamber and the second chamber is performed through the communication means. It proposes a separate storage container.

According to the above configuration, the holding means can positively hold the piercing element of the second housing member and the piercing element of the communication means in a separated state, It is possible to prevent accidentally performing a piercing operation. In addition, when necessary, when the external force, that is, the force applied by the operator, is slightly applied to a value higher than a predetermined value, the holding means is plastically deformed. As a result, the piercing operation is performed, and the piercing state is securely held by the plastically deformed holding means.

Therefore, the separation and storage container of the present invention has a small number of components, has a simple structure, and has a sterile condition because the communicating portion forming the communicating means is sealed. If the external force in the axial direction does not apply to the guide cover serving as the holding means, the guide force bar will not be plastically deformed, so the piercing needle that forms the piercing element of the communicating part There is almost no chance of accidentally piercing the piercing section. However, since there are no empty knocks, the melting operation is easy.

In a preferred specific configuration of the present invention, the predetermined value of the external force for plastically deforming the holding means is set in the dog based on the piercing resistance of the piercing element to the piercing portion. For example, 3 K gf or more, preferably in the range of 3 K gf to 5 K gf, particularly preferred. It is assumed to be 3.5 K gf.

Further, it is preferable that the holding means is constituted by a guide cover integrally formed in a bellows shape by blow molding of a thermoplastic resin, for example. In particular, in the case of pro-molding, the outwardly protruding ridges of the guide cover in the form of a jar are thinner and easier than the valleys that are recessed inward. Since it can be formed into a shape, suitable characteristics as a guide cover can be obtained.

In addition, other preferred specific configurations and advantages of the present invention can be understood from the accompanying drawings and the following description made with reference to the drawings.

'Brief description of the drawings

FIGS. 1 to 4 show an embodiment of the present invention. FIG. 1 is a perspective view of a medicine container covered with a packaging material, and FIG. FIG. 3 is an enlarged perspective view of the medicine container in the state, and FIG. 3 is an enlarged vertical sectional view of the medicine container shown in FIG. a), (b), (c) and (d) are explanatory views showing the usage state of the medicine container, respectively, and FIG. 5 is a perspective view of the medicine container showing another embodiment of the present invention. .

BEST MODE FOR CARRYING OUT THE INVENTION

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a perspective view of a drug storage container forming a separation storage container of the present invention covered with a packaging material, and FIG. 2 is a perspective view of the drug storage container. It is. In both figures ^: 1 and 1 indicate a drug container, and the drug container 1 is made of a flexible synthetic resin sheet, and the storage chamber 2 and the storage chamber 3 are independent of each other. And are integrally formed. The medicine container 1 is entirely covered with a rectangular packaging material 4, and is a solvent described below, which is sealed in the storage chamber 2 by the packaging material 4. The stability of the dissolution solution S is guaranteed. Dissolution liquid S, for example, physiological

:: There are 50 or 100 ml of saline or 5% glucose solution. In FIG. 2, a discharge port 5 is provided at the lower part of the storage chamber 2, and the discharge port 5 is further covered with an aluminum tube 6, so that the solution S does not go outside. ing .

At one end of the storage container 1, a hole 1a for hanging a hanger 14 of an infusion stand 13 to be described later is formed, and both chambers 2 and 3 are provided at an intermediate portion. Boundary part 1 b is shaped

Has been established. Between the upper part of the storage chamber 2 and the lower part of the storage chamber 3, there is a separable closing part 7 which is located in the storage chamber 2 and is located in the storage chamber 3 together with '' ′. A communication section 9 is provided as communication means having a bottle needle or a piercing needle 8 forming a communication element. The communicating portion has a cylindrical shape in which an end in the storage chamber 2 is closed, and a notch is formed in an inner peripheral surface so that the closing portion 7 is easily broken by an external force. The bottle needle 8 is provided with a return blade 8a, which makes it difficult for the piercing portion 11 to be described later to be pulled out. The middle part of the cylindrical communication part 9 is held at the boundary part 1b. Glass or resin solute storage member ¾ formed vial or solute container 10 is stored in storage room 3, and powder 1 is contained in chamber 1 Ob in this vial 10. The antibiotic A, which is a solute, enters. A rubber stopper 11 is inserted into the mouth 10a of this nodal 10 to form a piercing portion through which the above-mentioned bottle needle 8 can be pierced, and is fixed by a mouthpiece 1 la ( (Figure 3). A guide cover 12 in the form of a bellows is provided between the mouth 10a of the vial 10 and the bottom 3a of the storage chamber 3 formed by the boundary lb in FIG. I have. The guides 1 and 2 constitute the holding means. For example, the guide cover 12 applies an external force greater than a predetermined value by an operator's hand from the outside in the axial direction of the bottle needle 8, that is, the bottle needle 8 of the communication portion 9 is connected to the vial 10. A material that plastically deforms when it is put in the direction that penetrates the rubber plug 11 fitted into the mouth 10a, for example, a metal material such as aluminum or a thermoplastic material such as polypropylene. It is composed of resin. For this reason, as long as a predetermined force is not applied in the axial direction, the bottle needle 8 is held at a separated position as shown in FIG. 3, and the rubber stopper 11 can be pierced. In addition, the lysing solution S does not accidentally enter the vial 10. The guide cover 12 guides the bottle needle 8 to prevent the bottle needle 8 from being accidentally pierced except for the rubber stopper 11. Further, if the guide cover 12 is deformed and contracted, since it is plastically deformed, the deformed state is maintained, so that the piercing state of the bottle needle 8 is reliably maintained. As shown in FIG. 3, one end 12a of the guide cover 12 surrounds the mouth 10a of the dial and the rubber stopper 11 as well as the Fixed to dial 10. The other end 12b of the guide canopy 12 extends in the axial direction while surrounding the bottle needle 8 and is fixed to the bottom 3a.

When the guide cover 12 is blow-molded with thermoplastic resin, as shown in Fig. 3, the peaks of the guide cover 12 that protrude outward in the radial direction are formed. Since the portion 12c is thinner than the valley portion 12d which is recessed inward in the radial direction, better stretchability than the guide cover 12 can be obtained.

The prescribed value of the external force that causes the guide cover 12 to plastically deform is equivalent to the resistance when the needle 8 pierces the rubber stopper 11 of the nominal 10, that is, the piercing resistance. Or higher.

Usually, the piercing resistance is about 3 Kgf. Therefore, the predetermined value of the guide cover 2 is set to 3 Kgf as the minimum value in this case. Good. The upper limit of the predetermined value corresponds to the external force that can be applied by the operator, but the predetermined value is set in the range of 3 Kgf to 5 Kgf in consideration of the easiness of operation, and particularly preferably 3 Kgf. It is 5 Kgf.

When the guide cover 1 2. is formed of a metal material, it is preferable to use a method of press molding.

Next, a method of using the medicine container 1 having the above configuration will be described with reference to FIGS. 4 (a), (b), (c) and (d). First, the packaging material 4 shown in FIG. 1 that covers the medicine container 1 is removed. Then, the bottle needle 8 of the communication part 9 is guided by a predetermined external force into the rubber stopper 11 fitted to the boiler 10 Oa of the neutral 10 housed in the storage room 3. The cover 12 ··· is plastically deformed in the axial direction and contracted by being plastically pierced (see FIG. 4 (a)). Further, the closed portion 7 of the communication portion 9 is not broken or separated and the vial 10 The reservoir and the storage chamber 2 are communicated via the communication part 9 (see FIG. 4 (b)). Next, the dissolving solution S sealed in the storage chamber 2 is injected into the vial 10 via the communication section 9 with the storage chamber 2 up and the vial 10 down. Dissolve the antibiotic A in the vial 10 in powder. The solution obtained by dissolving the powdered antibiotic A is returned to the storage chamber 2 with the vial 10 upward and the storage chamber 2 downward. The above procedure is repeated to completely dissolve the antibiotic A in the powder in the vial 10 (see Fig. 4 (c)). "

The hole 1a of the medicine container 1 is passed through the hanger 14 of the infusion stand 13 and the medicine container 1 is hung on the hanger 14 (see FIG. 4 (d)). That is, the medicine container 1 is hung on the hanger 14 with the storage chamber 2 containing the liquid in which the powdered antibiotic A is dissolved down. The infusion set 15 includes a bottle needle 1 ^_ 6 piercing the discharge □ 5, a drip tube 1, a clamp 18, and an intravenous needle 19 pierced into a blood vessel or the like of the patient M. And a tube 20 connecting them.

As shown in Fig. 4 (d), the IV needle of the infusion set 15 19 is pierced into the blood vessel or the like of the patient M, the bottle needle 16 is removed from the aluminum cap 6 placed on the discharge port 5, and pierced into the discharge port 5 to clean the bottle. Adjust the method 18 and inject the liquid in which the antibiotic A in the powder in the storage chamber 2 of the medicine container 1 is dissolved into the patient M by intravenous drip.

The packaging material 4 (Fig. 1) was prepared after the antibiotic A was dissolved in the dissolution solution S by the piercing operation described above, and before being set in the infusion stand 13. You can remove it.

FIG. 5 shows another embodiment of the present invention, and since it has substantially the same configuration as the embodiment shown in FIG. 2, the same parts are denoted by the same symbols and their description is omitted. I do. In the embodiment shown in FIG. 2, the medicine storage container 1 has a flexible synthetic resin sheet in which the independent storage chamber 2 and the storage chamber 3 are integrally formed. In the present embodiment, the storage room 2 and the storage room 30 are integrated. The storage chamber 30 has a cylindrical shape with a janitor-shaped portion 3'0a formed on the outer peripheral surface. A hanging device 21 is attached to the end face of the storage room 3 こ. The other configuration and operation are the same as those in the embodiment shown in FIG. In addition, in this concavity-like portion, 30a ensures that the guide cover 12 is plastically deformed in the axial direction, and the piercing state of the penetration element 8 is confirmed. It has effects such as the following.

In the present invention, the configuration of the storage chamber 2 and the solute container 10 disclosed in the above embodiment is reversed, and In addition to the configuration in which a piercing portion is provided and a piercing element is provided on the solute container side, various modifications are possible without departing from the gist of the present invention. However, it is not limited to this.

Industrial applicability

As described above, the separation container according to the present invention is preferably used as an infusion bag for connecting a transfusion set to inject a drug intravenously into a patient. It can be widely used in fields where powdery or liquid solutes need to be aseptically dissolved in solvents. As described above, the present invention is applicable not only to the field of medicine for treating drugs and the like, but in the embodiment, the drug container is disclosed as an example of the separation container of the present invention. Therefore, the scope of the present invention is not limited to those related to “drugs” in a narrow sense.

Claims

Claim ^) Range

1. a first storage member having a first chamber having an outlet and a first substance stored therein;

A second fusible member having a second chamber for accommodating a second substance and a piercing portion;.

A piercing element capable of piercing the piercing portion of the second housing member with a predetermined piercing resistance when necessary; and a piercing element that extends into the first chamber and is always connected to the first chamber. The communication between the chamber and the piercing element is closed and separated when necessary, and a separation part is provided to allow the communication to be performed when necessary, and the first chamber is connected to the first chamber when necessary. A means of aseptic communication with the second chamber;

In a separate storage container,

It is disposed between the second housing member and the first chamber, surrounds the piercing element, and always pierces the piercing it portion of the second housing member. When the external force is applied along the direction of the axis of the piercing element together with a predetermined value or more, it is plastically deformed along the axial direction. A piercing element for the piercing portion is provided with holding means for permitting piercing and maintaining the piercing state, and piercing the piercing portion by the piercing element. After the communication is established, the closed portion of the communication means is separated, whereby aseptic communication between the first chamber and the second chamber is performed via the communication means. A separate container for chicks, characterized in that

2. The predetermined value of the external force for plastically deforming the holding means is larger than the piercing resistance of the piercing element to the piercing portion. Separated storage volume described in section

3-The predetermined value of the external force that causes the holding means to plastically deform is

The separated storage container according to claim 2, wherein the container is 3 kgf or more.

4-The predetermined value of the external force for plastically deforming the holding means is 0 in the range of 3 Kgf to 5 Kgf, preferably 3.5 Kgf. Separation container described in paragraph 2. '

5. The separation container according to any one of claims 1 to 4, wherein the holding means comprises a guide cover having a bellows shape.

6. The guide cover surrounds the stimulating portion of the second housing member and is fixed to the second housing member at one end, and the stimulating area is provided at the one end portion. It has a storage chamber that extends in the axial direction surrounding the ment and stores the second storage member, and has another end portion fixed to a boundary part that partitions the first chamber. The separated container according to claim 5.

7-the communicating means comprises a central part fixed to the boundary part in a liquid-tight state, a distal end to which a piercing element is attached, and a proximal end provided with the closing part. The separation storage container according to claim 6, wherein the separation storage container is characterized by comprising:

8. The separation container according to claim 5, wherein the guide cover is formed integrally by blow molding with a thermoplastic resin.

9. The projecting ridge of the bellows-shaped guide cover is formed to be thinner than the valley recessed inward. Separation container described in paragraph 5

I, 0. The separation and storage container according to claim 5, wherein the guide cover is integrally formed of a metal material by a press molding method.

II. The first chamber, wherein the first chamber is formed of a synthetic resin sheet, and a storage chamber for storing the second storage member is integrally formed in the sheet. Item 1. A separate storage container.

12. The first chamber is formed of a synthetic resin sheet, and a storage chamber for storing the second receiving member is provided separately from the sheet. 2. The separation container according to claim 1, wherein the container is formed of a synthetic resin-fat sheet, and further has a rib-shaped portion provided on an outer peripheral surface of the sheet.

13. The container according to claim 1, wherein the stimulating element comprises a piercing needle having a return blade.

14. The first substance is a solvent, the solvent is contained in a storage chamber forming the first chamber, and the second substance is a solute dissolved by the solvent. The separation container according to claim 1, wherein the solute is stored in the second chamber formed inside a solute storage member forming a second storage member.

15. The separation container according to claim 14, wherein the solvent is a solution, and the solute is a powdered drug.