JP3352470B2 - Bag assembly - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a bag assembly having a syringe in a bag, and more particularly to a bag assembly capable of injecting and blending a drug solution.

[0002]

2. Description of the Related Art Prior to administration of an infusion to a patient, drugs such as vitamins, heparin and antibiotics are added to the infusion filled in the infusion bag as required. I have.

[0003] To mix such a drug, first, the puncture needle of the syringe is pierced into the elastic stopper of the infusion bag, and the plunger is pulled to collect the infusion in the infusion bag into the syringe. Transfer to a container containing the drug (powder) to be blended, dissolve and mix the drug in this container, then aspirate and collect the drug mixture again with the syringe,
This is performed by inserting a puncture needle into an elastic stopper of the infusion bag and pushing the plunger to inject the drug mixture into the infusion bag.

[0004] However, such a chemical solution is formulated
There is a disadvantage that the operation procedure is complicated and the time required for blending is long. In particular, prompt response is essential for emergency patients, but it is disadvantageous when formulating a drug solution to be administered to such patients.

Furthermore, since the compounding operation of the above-mentioned chemical solution, particularly the dissolution and mixing of the chemical, are mostly performed in contact with the atmosphere, there is a risk of bacterial contamination and foreign matter contamination. In addition, when a plurality of types of drugs are compounded, the above-mentioned drawbacks have become more remarkable because the above-described compounding operation is repeated.

[0006]

SUMMARY OF THE INVENTION An object of the present invention is to provide a bag assembly which can perform injection and compounding of a medicine in a short time by a simple operation without causing contamination.

[0007]

This and other objects are attained by the present invention which is defined below as (1). In addition, the following (2)-
(15) is preferred.

(1) A bag set including a bag in which a syringe is fixed to a flexible bag body so as to protrude inside the bag body in a liquid-tight manner, and at least one container loaded in the syringe. A three-dimensional syringe, wherein the syringe communicates with an outer cylinder, a tube installed in the outer cylinder, and one end of the tube, and projects from the bottom of the outer cylinder into the bag body. Part, a sealing member for sealing at least a part of a flow path from the inside of the tube to the inside of the protrusion, a needle tube provided at the other end of the tube, and an outer peripheral portion of the needle tube. A connection part, the container includes a bottomed cylindrical container body, and a gasket that can slide in a liquid-tight manner along the inner surface of the container body, and the needle tube is piercable through the gasket. And a locking portion for locking the connecting portion. The sealing of the flow path by the stopper member is released, the container is inserted into the outer cylinder from the gasket side, the needle tube is pierced into a thin portion of the gasket, and the connecting portion and the locking portion are inserted. Wherein the container body is moved relative to the syringe in the axial direction thereof so that at least the liquid in the container is injected into the bag body. .

(2) The bag assembly according to the above (1), wherein a solid or liquid medicine is placed inside the container.

(3) The bag assembly according to the above (1) or (2), wherein the inside of the container is in a reduced pressure state.

(4) The bag assembly according to any one of (1) to (3), further comprising a regulating means for regulating an axial position of the gasket with respect to the container body.

(5) The bag assembly according to any one of (1) to (4), further including a film for sealing an opening of the container body.

(6) The bag assembly according to any one of (1) to (5), wherein the locking portion is formed by a concave portion, and the connecting portion is formed by a convex portion fitted into the concave portion. .

(7) The bag assembly according to any one of (1) to (6), wherein the gasket can reciprocate in the container body by locking the locking portion and the connecting portion. .

(8) The above-mentioned (1) to (7), further comprising an enclosing member which encloses the needle tube and can be pierced by the second needle tube.
The bag assembly according to any one of the above.

(9) The bag assembly according to any one of (1) to (8), further including a film for sealing an opening on a rear end side of the outer cylinder.

(10) The bag assembly according to any one of (1) to (9), wherein the sealing member is provided on the projecting portion.

(11) The bag assembly according to any one of (1) to (10) above, wherein the sealing member is rupturable and can be opened.

(12) The bag assembly according to any one of (1) to (11), wherein the syringe is fixed to an edge of the bag body.

(13) The bag assembly according to any one of (1) to (12), wherein a liquid is contained in the bag body.

(14) The syringe according to any one of (1) to (13), wherein a gripping member is attached to a bottom of the container body.

(15) The bag assembly according to any one of (1) to (14), wherein a plurality of containers each containing a drug having a different component are exchanged and used.

[0023]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, a bag assembly according to the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings. The bag assembly of the present invention includes a bag 100 having a syringe 1 and at least one container 10 loaded in the syringe 1. Hereinafter, these configurations will be sequentially described.

FIG. 1 is a partially cutaway plan view showing an example of the configuration of a bag according to the present invention. For convenience of description, the upper side in FIG. 1 is referred to as a front end, and the lower side is referred to as a rear end. As shown in FIG. 1, a bag (infusion bag) 100 is made of, for example, soft polyvinyl chloride, polyethylene, polypropylene, polyester, ethylene-vinyl acetate copolymer, polyamide, polyurethane, polyester, polyamide, olefin, A bag body 101 is formed by fusing or adhering ends of a sheet material made of a flexible resin such as various kinds of elastomers such as styrene or a mixture thereof to form a bag. In the bag body 101, for example, an infusion 106 of about 50 to 2000 ml is put.

An opening 102 for taking out the infusion 106 in the bag is formed at the tip of the bag body 101.
This opening 102 is sealed by an elastic plug 103. On the other hand, the syringe 1 is fixed to the rear end of the bag body 101 so as to protrude inside the bag body 101. In this case, the syringe 1 has a rear end portion at a fusion portion 104 formed at the rear end edge of the bag body 101.
The bag body 1 is sandwiched between the sheet materials and fused.
01 is fixed in a liquid-tight manner.

Further, both ends of a band-shaped hanger 105 for suspending the bag 100 at a bedside, for example, are fixed to the fusion portion 104 by fusion. In addition,
In the illustrated example, almost the entirety of the syringe 1 is the bag body 101.
However, in the present invention, a part of the syringe 1, for example, only the tip part, may be located inside the bag body 101. The position where the syringe 1 is fixed to the bag main body 101 is the position of the bag main body 10 as shown in the figure.
The edge is not limited to the rear edge, but may be the edge of the front end or the side edge, or may be the front or back in FIG.

Next, the configuration of the syringe 1 will be described with reference to FIGS. 2 is a sectional view taken along the line II-II in FIG. 1, and FIG. 3 is a view taken along the line III-III in FIG. For convenience of description, the upper side in FIG. 2 is referred to as a front end, and the lower side is referred to as a rear end.
As shown in FIG. 2, the syringe 1 has a cylindrical outer cylinder 2 having a bottom 2 a on the distal end side, and the distal end of the outer cylinder 2 has a protrusion projecting from the bottom 2 a into the bag body 101. Part 3
Is installed.

The protruding portion 3 has a flexible tube 31 whose rear end is fixed to the bottom portion 2a in a liquid-tight manner, and a liquid-tight tube 31 for sealing the flow path in the tube 31. And a sealing member 32 fitted therein.

The sealing member 32 is formed of a cylindrical body whose front end is closed by a solid columnar portion 321, and has a thin and fragile broken portion 322 formed on the outer periphery thereof. By grasping the distal end of the tube 31 from the outside of the bag 100 with fingers or the like, bending the solid columnar portion 321 together with the tube 31 to break the break portion 322, and separating the solid columnar portion 321, the flow path can be opened. It becomes possible. The tube 31
Has a function of preventing the sharp edge portion generated by the breakage from damaging the sheet material of the bag body 101 when the solid columnar portion 321 is broken and separated.

As a constituent material of the sealing member 32, for example, a hard resin such as polyester such as hard polyvinyl chloride, polycarbonate, and polyethylene terephthalate can be used. As such a sealing member 32, a click chip manufactured by Terumo Corporation can be used.

The material of the tube 31 is as follows.
Examples thereof include soft resins such as soft polyvinyl chloride, polyethylene, and polypropylene, silicone rubber, and various elastomers such as urethane, polyester, polyamide, olefin, and styrene, and mixtures thereof.

In the present invention, a means for preventing the separated solid columnar portion 321 from coming out of the tube 31 and falling into the bag body 101 may be provided.
As an example of this means, a configuration in which a ring (not shown) having an inner diameter smaller than the outer diameter of the solid columnar portion 321 as a stopper of the separated solid columnar portion 321 is fitted into the distal end of the tube 31. No.

In the present invention, the sealing member is not limited to a member that can be opened by breaking as described above. For example, a member that can be closed with the tube 31 interposed therebetween, or a detachable member that can be detachably attached to the tip of the protruding portion 3 It may be a plug or the like that fits into the connector. Inside the outer cylinder 2 of the syringe 1, a tube 4 whose leading end communicates with the inside of the protruding portion 3 is installed substantially concentrically with the outer cylinder 2. In the example shown in the figure, the tube 4 is the bottom 2 of the outer cylinder 2.
a is preferably fixed by fusion or adhesion.
The tube 4 may be formed integrally with the sealing member 32.

At the rear end side of the tube 4, a sharp needle tip (blade tip)
A needle tube 5 having 51 is installed with the needle tip 51 facing the rear end. On the outer peripheral portion of the needle tube 5, a connecting portion 6 that can be locked by a locking portion 16 formed on a gasket 12 of the container 10 described later is formed. As shown in FIG. 2, the connecting portion 6 is composed of a pair of fan-shaped (wing-shaped) small pieces protruding in the radial direction of the needle tube 5. In the illustrated example, the connecting portion 6
Is formed integrally with the tube 4.

As the constituent materials of the outer cylinder 2, the tube 4, and the connecting portion 6, for example, polyvinyl chloride, polyethylene, polypropylene, polystyrene, poly- (4-
Methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, polyester such as polyethylene terephthalate, butadiene-styrene copolymer, polyamide (for example, nylon 6, nylon 6.6, nylon 6.6) , Nylon 12) or ceramics such as alumina. Among them, polypropylene, polyester, poly- (4
Preference is given to resins such as -methylpentene-1). In addition, these materials, in order to ensure the visibility of the inside,
Preferably, it is substantially transparent.

The needle tube 5 is preferably made of, for example, a metal such as stainless steel, titanium or aluminum or a hard resin. Around the needle tube 5, a covering member 7 that covers at least the needle tip 51 of the needle tube 5 is provided. When the syringe 1 is not used, the envelope member 7 is
And prevents the liquid in the tube 4 from leaking out from the needle tip 51.

As such an enclosing member 7, for example,
A film made of various rubber materials such as natural rubber, isoprene rubber, butadiene rubber, silicone rubber, and latex rubber, which can be easily penetrated by the needle tip 51, is preferably used.

A plate-like flange 2c is formed integrally with the outer cylinder 2 around the rear end opening 2b of the outer cylinder 2. The flange 2c is located outside the bag body 101, and is used when a container 10 described later is inserted into the outer cylinder 2 or when the outer cylinder 2
When pulling out from the inside, the finger is put on the flange 2c to fix the syringe 1.

Further, in the syringe 1 when not in use, a film 8 for sealing the rear end opening 2b of the outer cylinder 2 preferably in an airtight manner is adhered to the rear end face of the flange 2c. Thereby, contamination inside the syringe 1 is prevented. In addition,
When using the syringe 1, the film 8 is peeled off. At this time, a tab 81 is formed at the edge of the film 8 so that the film 8 can be easily peeled off.

As the film 8, a single layer made of a resin such as polyethylene, polypropylene, ionomer, polyester such as polyethylene terephthalate, polystyrene, poly- (4-methylpentene-1), polyamide, or a metal foil such as an aluminum foil is used. Or a laminate obtained by laminating (laminating) two or more of these layers. Since the laminate of the metal foil and the resin layer has low gas permeability, the use of such a film 8 improves the hermeticity of the outer cylinder 2 and effectively prevents invasion of bacteria and the like. It is preferable because it is possible.

In the syringe of the present invention, the films 8 and 19 may be provided as needed, and may not be present. 4 is a longitudinal sectional view showing a configuration example of the container in the present invention, FIG. 5 is a plan view of a gasket in the container shown in FIG. 4, FIG. 6 is a sectional view taken along line VI-VI in FIG. FIG. 7 is a sectional view taken along line VII-VII in FIG. 5. For convenience of description, the upper side in FIGS. 4, 6, and 7 is referred to as a front end, and the lower side is referred to as a rear end.

As shown in FIG. 4, the container 10 mainly includes a cylindrical container body 11 having a bottom and an open end, and a gasket 12 which can slide in a liquid-tight manner along the inner surface of the container body 11. It is composed of

The container body 11 is made of the same resin material or glass material as the outer cylinder 2 and the like, and is preferably substantially transparent in order to ensure the visibility of the inside. The outer diameter of the container body 11 is smaller than the inner diameter of the outer cylinder 2, and
The inner diameter of the container body 11 is larger than the outer diameter of the tube 4 and the maximum diameter of the connecting portion 6. Thereby, the container main body 11 can be inserted to the inner part of the outer cylinder 2.

The total length of the container body is preferably substantially equal to or greater than the total length of the outer cylinder 2. Particularly, regardless of the posture of the container 10, the chemical solution in the container 10 is discharged with as little residue as possible. Preferably, the rear end face 122 of the gasket 12 can be brought into contact with the bottom inner surface 113 of the container body 11 when the container body 11 is inserted to the innermost part of the outer cylinder 2 so that the container body 11 can be inserted.

On the inner surface of the container body 11,
A predetermined distance from 11 to the rear end side (for example, about 5 to 20 mm)
A ring-shaped protrusion 112 is formed at the separated position along the inner periphery of the container body 11. This protrusion 112
It is a restricting means for restricting the gasket 12 in the axial direction with respect to the container body 11 by engaging with a rear end face 122 of the gasket 12 described later. That is, when the pressure inside the container 10 is reduced, the gasket 12 prevents the gasket 12 from moving to the rear end side of the container main body 11 due to the pressure difference from the atmospheric pressure. To prevent the gasket 12 from being moved to the rear end side of the container body 11 by being pressed, or
When the gasket 12 is moved to the distal end side or when the container 10 is withdrawn from the syringe 1, the gasket 12 plays a role in preventing the gasket 12 from easily coming off from the container body 11.

In the container 10 when not in use, the container body 1
A film 19 for sealing the tip opening 111 preferably in a hermetically sealed manner is attached to the tip of 1. Thereby, contamination of the inside of the locking portion 16 of the gasket 12 and the space 15 is prevented, and sterility is maintained. In addition, container 1 when not in use
In a case where the inside of the container 0 is kept in a reduced pressure state, the use of the gas impermeable film 19 allows the distal end opening 111 to be airtight, which is advantageous for maintaining the reduced pressure state in the container 10. As the film 19, the same film as the film 8 can be used.

As shown in FIGS. 4, 5 and 6, the gasket 12 is made of various rubber materials (particularly vulcanized) such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber and silicone rubber. Treated) or various elastomers such as polyurethane-based, polyester-based, polyamide-based, olefin-based, and styrene-based elastomers, or a columnar member made of an elastic material such as a mixture thereof. The gasket 12 is not limited to the whole made of the above material, but may be one in which at least the protrusion 18 and the thin portion 14 are made of the above material.

In the center of the gasket 12, a thin portion 14 through which the needle tube 5 of the syringe 1 can be inserted is formed.
The thickness of the thin portion 14 is, for example, about 0.5 to 10 mm.

Further, a space 15 for accommodating and holding the enclosing member 7 when the needle tube 5 is pierced into the thin portion 14 is formed on the distal end side of the thin portion 14. , A locking portion 16 is formed. This locking part 1
6 is a recess in which the connecting portion 6 of the syringe 1 is locked,
A pair of fan-shaped spaces 161 communicating with the space 15
And an opening 162 through which the connecting portion 6 communicating with the space 161 and being released to the distal end surface 121 of the gasket 12 can pass.

In the space 161, the connecting portion 6 is rotatable by a predetermined angle (for example, about 50 to 130 °), and the contact surface 16 is substantially perpendicular to the distal end surface 121 of the gasket 12.
3, 163, and its rotation is regulated. Connecting part 6
In the state in which the connecting portion 6 is in contact with the contact surface 163, the movement of the connecting portion 6 in the leading end direction and the rear end direction with respect to the locking portion 6 is restricted. Further, the contour shape of the opening 162 is substantially equal to that of the connecting portion 6 (see FIG. 5).

The space 13 in which the needle tip 51 is located when the needle tube 5 is pierced into the thin portion 14 is located on the rear end side of the thin portion 14.
Is formed. Also, inside the gasket 12,
At least one ventilation hole 17 is formed, one end of which communicates with the space 13 and the other end of which is open to the outer peripheral surface 123 of the gasket 12. The vent hole 17 is for discharging water vapor when the medicine contained in the container 10 is freeze-dried. Therefore, the ventilation holes 17 are provided as necessary according to the form of the medicine stored in the container 10.

A plurality of ring-shaped projections 18 are formed on the outer peripheral surface 123 of the gasket 12 over the entire circumference.
When the gasket 12 slides, the projecting portion 18 has a function of closely adhering to the inner peripheral surface of the container body 11 to maintain airtightness and to maintain appropriate slidability.

In such a container 10, the container main body 11 also has a function as a plunger for moving the gasket 12 with respect to the container main body 11, and the gasket 12 is used to seal the container main body 11. It has both a function as a stop member and a function to obtain communication / interruption with the inside of the needle tube 5. Therefore, the container 10 can be composed of only the container body 11 and the gasket 12, which are the minimum necessary members, and the number of parts is smaller than that of a conventional container having a rubber stopper and a plunger rod dedicated to piercing the needle tube. The configuration is extremely simple and the operation is easy.

The inside of such a container 10 may be empty when not in use, but it is usually preferable that a predetermined amount of medicine is previously stored. The drug may be liquid or solid (including semi-solid). A typical example of a solid drug is a tablet or a powder (granule) drug 120 as shown in the figure, and in particular, a powdery powder in that it is easily dissolved or dispersed by a liquid introduced into the container 10. Are preferred. Such a powdered drug 120 can be easily obtained by, for example, freeze-drying.

When a solid drug is placed in the container 10, the inside of the container 10 may be in a state substantially equal to the atmospheric pressure, but may be in a reduced pressure state (for example, 0.1 to 760).
mmHg). In addition, one container 1
The drug 120 encapsulated in the container 0 is usually composed of a single active ingredient, but may be a combination preparation containing two or more active ingredients.

Specific examples of the drug 120 include vitamins (multivitamins), various amino acids, antithrombotics such as heparin, insulin, antibiotics, antitumor agents, analgesics, inotropic agents, intravenous anesthetics, Parkinson's agent, ulcer treatment agent, corticosteroid agent, agent for arrhythmia, correction electrolyte and the like.

According to the present invention, in order to prevent the solid medicine that could not be dissolved or dispersed in the container 10 from being injected into the bag 100 together with the chemical solution, the inside of the flow path such as the tube 4 and the projection 3 is prevented. Or the rear end face 1 of the gasket 12
For example, a filter (not shown) for blocking the passage of the solid drug can be provided on the filter 22 or the like. As this filter, for example, a membrane filter, a mesh, a woven fabric,
Nonwoven fabrics and the like can be mentioned.

It is preferable that the interior of the syringe 1 and at least the interior of the container 10 have been previously subjected to a sterilization treatment such as high-pressure steam sterilization, gas sterilization or radiation sterilization. Next, an example of a method of using the bag assembly of the present invention will be described with reference to FIGS.

A. Usage method when the inside of the container 10 is previously in a reduced pressure state [1] First, the protruding portion 3 is bent from the outside of the bag body 101 with a finger or the like to break and remove the solid columnar portion 321 of the sealing member 32. . Thereby, the sealing of the flow path by the sealing member 32 is released, and the flow path in the protruding portion 3 and the flow path in the tube body 4 following this are communicated with the inside of the bag.

[2] Next, the films 8 and 19 are respectively peeled off, and the container 10 is inserted into the outer cylinder 2 from the front end side through the rear end opening 2b of the outer cylinder 2 to connect the connecting portion 6 to the gasket 1
The needle tube 5 is passed through the thin portion 14 of the gasket 12 so that the needle tip 51 is located in the space 13.

Here, since the inside of the container 10 has been previously depressurized, the infusion 106 in the bag 100 is caused to flow through the protruding portion 3 and the pipe as shown by the arrow in FIG. It is introduced into the container 10 through the body 4 and the lumen of the needle tube 5 sequentially.

The needle tip 51 penetrates the enclosing member 7 prior to the puncturing of the thin portion 14, and the encapsulating member 7
In the space 15 of the gasket 12, it is held in a state of being compressed in a bellows shape.

[3] Next, the container 10 is shaken or vibrated to dissolve or disperse the drug 120 in the infusion solution introduced into the container 10, and the drug solution 1 containing the active ingredient of the drug 120 is dispensed.
08. In addition, as this chemical liquid 108, the chemical 12
0 solution, suspension (emulsion) and the like.

[4] Next, as shown in FIG.
0 at the rear end (bottom) of the container body 11
Is inserted into the outer cylinder 2. Since the connecting portion 6 and the locking portion 16 are locked, only the container body 11 moves in the distal direction while the gasket 12 is connected to the rear end of the tube 4. Thereby, the rear end of the gasket 12 and the container body 11
And the volume of the portion surrounded by
08 is sequentially injected into the bag 100 through the lumen of the needle tube 5, the tube body 4, and the protruding portion 3, as shown by the arrow in FIG.

[5] In the chemical liquid injection operation of the above [4], even if the container main body 11 is inserted into the outer cylinder 2 until the rear end face 122 of the gasket 12 contacts the bottom inner surface 113 of the container main body 11, Since the liquid medicine 108 remains in the body 4 and the inner cavity of the protruding portion 3, the entire amount of the liquid medicine 108 cannot be injected into the bag 100 by a single pushing operation of the container 10. Therefore, once the container main body 11 is inserted into the outer cylinder 2 to a certain depth, the container main body 11 is pulled to the rear end side, and the infusion solution 106 in the bag 100 is introduced into the container 10 along the same route as described above. Then, the remaining chemical liquid 108 is diluted, and the container body 11 is pressed again into the outer cylinder 2 and inserted.
By repeating the reciprocating motion of the container body 11 several times, the chemical liquid 108 can be supplied into the bag 100 without waste, and a precise amount of the chemical can be compounded.

When the container body 11 is pulled to the rear end side, the container 10 is rotated by a predetermined angle counterclockwise in FIG. 5 with respect to the syringe 1, and the connecting portion 6 is brought into contact with the contact surface 163. Let it. As a result, the connecting portion 6 cannot pass through the opening 162, and only the container main body 11 is pulled out while the gasket 12 is connected to the rear end of the pipe 4, and the rear end of the gasket 12 and the container main body 11 The volume of the portion surrounded by is increased, and the infusion 106 is introduced.

Also, when the gasket 12 slides, a predetermined resistance is applied when the projection 18 passes through the projection 112 of the container body 11, so that the gasket 12 is prevented from being accidentally pulled out of the container body 11. You.

[6] In the case where a drug having a different component is further mixed into the bag 100, the container 10 is rotated in the opposite direction to the above to release the engagement between the connecting portion 6 and the locking portion 16, and then, The container 10 is withdrawn from the syringe 1, and then a similar container 10 containing a drug to be newly blended is set in the syringe 1 in the same manner as in the above [2].
The same operation as in [5] is performed.

As described above, when a plurality of kinds of drugs having different components are blended, a plurality of containers 10 containing the respective drugs are prepared, and these may be appropriately replaced and used. It is simple and the time required for compounding is short. Further, in the case of such a compounding agent, the chance of contact with the outside air is extremely small, and there is no possibility of bacterial contamination or foreign matter contamination.

The used container 10 should be filled with a gasket 1 in order to minimize the amount of liquid remaining in the container 10.
2 is preferably withdrawn from the syringe 1 while the rear end surface 122 is in contact with or close to the bottom inner surface 113 of the container body 11.

When the gasket 12 is pulled out of the needle tube 5, the envelope member 7 which has been compressed in a bellows shape is instantaneously restored to the original shape and envelopes the needle tip 51.
The liquid is prevented from leaking from 1 and scattered around. The operation [2] may be performed before the operation [1].

B. Usage method when the pressure in the container 10 is substantially equal to the atmospheric pressure First, the films 8 and 19 are peeled off, and the container 10 is inserted into the outer tube 2 from the front end side through the rear end opening 2b of the outer tube 2. Then, the connecting portion 6 is passed through the opening 162 of the gasket 12 and locked in the space 161, and the needle tube 5 is pierced into the thin portion 14 of the gasket 12, and the needle tip 51 is inserted into the space 1.
Position 3

Next, after the solid columnar portion 321 of the sealing member 32 is broken and removed in the same manner as described above, the container body 11 is pressed toward the distal end, and the container body 11 is inserted into the outer cylinder 2. The volume of the portion surrounded by the rear end of the gasket 12 and the container body 11 is reduced. When the container 10 is used in which the gasket 12 is located near the rear end of the container body 11 in advance, this pushing-in operation is unnecessary.

Next, the container body 11 is pulled to the rear end side, and the infusion solution 106 in the bag 100 is transferred to the container 10 along the same route as described above.
Introduce within. After that, the same operation as in the above [3] to [6] is performed.

C. Liquid medicine (medical solution) in advance in the container 10
How to use when is stored After performing the same operations as in the above [1] and [2], the same operations as in the above [4] to [6] are performed.

In the bag assembly of the present invention, even if the container 10 has any of the above-mentioned forms A to C, the container 10 can be used by appropriately replacing them with the syringe 1.
The above-described compounding (injection) of the drug is not limited to being performed with respect to the infusion bag, and includes, for example, a liquid other than the infusion such as a physiological saline solution or a dialysate, blood, or plasma. It can also be done on bags that do.

FIG. 10 is a partial longitudinal sectional view showing another configuration example of the syringe and the container according to the present invention. The syringe 1A and the container 10A shown in the figure are different from each other in the configuration of the connecting part and the locking part, and the other parts are substantially the same as the syringe 1 and the container 10.

The connecting portion 6A of the syringe 1A is connected to the needle tube 5
And a circular convex portion formed on the outer periphery of the end portion of the tube body 4 on the side thereof, and a male screw 61 is formed on the outer peripheral surface thereof. On the other hand, the locking portion 16A of the container 10A is
It is formed at a substantially central portion on the distal end side of 2A, and is constituted by a circular concave portion released to the distal end surface 121. On the inner peripheral surface, a female screw 164 to be screwed with the male screw 61 is formed.

The engagement between the connecting portion 6A and the locking portion 16A is performed by rotating the syringe 1A and the container 10A relative to each other.
1 and the female screw 164 are screwed together. 11 is a plan view showing another configuration example of the container according to the present invention, FIG. 12 is a longitudinal sectional view showing the configuration of the distal end portion of the container 10B shown in FIG. 11, and FIG. It is a longitudinal cross-sectional view which shows a structure. For convenience of description, the upper side in FIGS. 12 and 13 is referred to as a front end, and the lower side is referred to as a rear end.

The container 10B shown in these figures is different from the container 10 or 10A mainly in the configuration of the gasket and the restricting means for restricting the position of the gasket in the axial direction with respect to the container main body 11. In the container 10B, the protrusion 112 is not provided on the inner peripheral surface of the container body 11.

The gasket 20 in the container 10B has a thin portion 22 similar to the above at substantially the center, and a space 21 similar to the above is formed at the rear end side of the thin portion 22. Further, a core material 23 made of, for example, the above-described resin is buried in the gasket 20 on the tip side from the thin portion 22. A substantially central portion of the core member 23 includes a space 24 for storing and holding the same encapsulating member 7 as described above, and a locking portion 25 formed of a circular recess similar to the locking portion 16A communicating with the space 24. Are formed. In addition, the locking portion 25
The inner peripheral surface of the female screw 2 is screwed with the male screw on the outer periphery of the connecting portion.
6 are formed.

At the tip of the core member 23, three fan-shaped small pieces 27 extending radially from the center of the core member 23 at intervals of 120 ° are formed. On the other hand, a ring-shaped locking member 28 is fixed to the distal end of the container main body 11 by fitting to the distal end portion 114 of the container main body 11. As shown in FIG. 12, the inner opening of the locking member 28
The trunk 231 of the core member 23 is inserted.

The inner opening of the locking member 28 has a portion whose diameter is substantially equal to or slightly larger than the outer diameter of the body portion 231 of the core member 23 (to correspond to the small piece 27,
(Formed at three locations at 120 ° intervals from the center)
An inner diameter enlarged portion 29 having an inner diameter larger than the diameter of a circle connecting the outermost circumferences of the small pieces 27 is arranged alternately along the circumferential direction. In this case, each inner diameter enlarged portion 29
Are arranged at intervals of 120 ° from the center, and have an inner diameter and an opening angle larger than those of the small pieces 27.

In the state shown in FIGS. 11 and 12, the distal end surface of the gasket 20 contacts the rear end surface (the inner surface of the container) of the locking member 28, and each small piece 27 of the core material 23 is
Since the locking member 28 is locked at the portion between the adjacent inner diameter enlarged portions 29 and is in a so-called locked state, the movement of the gasket 20 to the front end side and the rear end side is restricted.

Further, the core member 23 is
When each of the small pieces 27 is rotated and overlapped on the corresponding inner diameter enlarged portion 29, the three small pieces 27 pass through the inner diameter enlarged portion 29 at the same time, and the movement restriction to the rear end side is released as shown in FIG. The gasket 20 can slide in the container body 11 toward the rear end.

The container 1 having such a restricting means
At 0B, instead of the locking portion 25, the same configuration as the locking portion 16 may be adopted.

FIGS. 14, 16 and 18 are longitudinal sectional views showing other examples of the structure of the container according to the present invention.
FIGS. 5 and 17 are bottom views of the container shown in FIGS. 14 and 16, respectively.

Each of the containers shown in these figures has a ring-shaped rib 11 on the outer periphery of the rear end (bottom) of the container body 11.
5 are provided, and gripping members (container moving aids) 30A to 30C which are engaged with the ribs 115 and fixedly installed on the bottom of the container main body 11 are provided.

The gripping member 30A shown in FIGS. 14 and 15
Has an engaging portion 300 to be engaged with the rib 115 and a flange 301 formed on the opposite side to the engaging portion 300.

The gripping member 30B shown in FIGS. 16 and 17
Has an engaging portion 300 that engages with the rib 115, and a flange 302 formed on the opposite side to the engaging portion 300.
The engagement portion 300 and the flange 302 are connected by a shaft 303.

The gripping member 30C shown in FIG.
5 is formed, and a concave portion 304 suitable for grasping by a finger or the like is formed on the outer periphery on the opposite side to the engaging portion 300.

In such a container, the holding members 30A to 30A-3
Since the operation of moving the container with respect to the syringe main body is performed by gripping the flange 301, 302 or the concave portion 304 of the OC with a finger or the like, the operation, particularly the operation of moving the container in the direction of pulling the container from the syringe main body, can be easily and reliably performed. it can. This is particularly effective when the length of the container body 11 is relatively short.

The shape and structure of the gripping member are not limited to those shown in the drawings. In addition, in the configuration examples illustrated in FIGS. 14 to 18, the container body 11 and the holding members 30 </ b> A to 30 </ b> C are configured as separate members, but they may be integrally formed.

Although the bag assembly according to the present invention has been described with reference to the respective structural examples shown in the accompanying drawings, the present invention is not limited to these examples. For example, the configuration of the connecting portion and the locking portion is not limited to the configuration including the convex portion and the concave portion as illustrated, but may be, for example, surfaces that are joined to each other. In this case, it is only possible to slide the gasket 12 toward the rear end side with respect to the container body 11 by inserting the container body 11 into the outer cylinder.

The bag according to the present invention is not limited to a bag in which a liquid is previously contained in the bag body 101,
When necessary, a liquid such as an infusion is supplied from the opening 102 or the like to the bag body 1.
01 may be filled.

[0096]

As described above, according to the bag assembly of the present invention, it is possible to inject a liquid into a bag or mix a medicine in a short time with a simple operation, and to cope with an emergency. Is advantageous. In addition, during operation such as compounding of a drug, there is very little chance that various parts of the syringe such as the inside of the container come into contact with the outside air, so that bacterial contamination and contamination of foreign matter can be prevented.

In particular, when a plurality of drugs having different active ingredients are blended, a plurality of containers containing the respective drugs may be appropriately replaced and used, and the above-mentioned excellent operability and aseptic retention effect are more improved. Effectively demonstrated. Further, when the gasket can be reciprocated in the container body by locking the locking portion and the connecting portion, the medicine in the container can be discharged without waste.

Further, since the syringe is formed integrally with the bag, the number of parts is small, and since the syringe protrudes inside the bag body, the syringe is compact.
It is easy to handle and saves storage space.

[Brief description of the drawings]

FIG. 1 is a partially cutaway plan view showing a configuration example of a bag according to the present invention.

FIG. 2 is a sectional view taken along line II-II in FIG.

FIG. 3 is a view along line III-III in FIG. 2;

FIG. 4 is a longitudinal sectional view showing a configuration example of a container in the present invention.

5 is a plan view of a gasket in the container shown in FIG.

FIG. 6 is a sectional view taken along line VI-VI in FIG. 5;

FIG. 7 is a sectional view taken along line VII-VII in FIG. 5;

FIG. 8 is a longitudinal sectional view showing a use state of the bag assembly of the present invention.

FIG. 9 is a longitudinal sectional view showing a use state of the bag assembly of the present invention.

FIG. 10 is a partial longitudinal sectional view showing another configuration example of the syringe and the container according to the present invention.

FIG. 11 is a plan view showing another configuration example of the container according to the present invention.

FIG. 12 is a longitudinal sectional view showing a configuration of a distal end portion of the container shown in FIG.

FIG. 13 is a longitudinal sectional view showing the configuration of the distal end portion of the container shown in FIG. 11 (when the gasket is moved).

FIG. 14 is a longitudinal sectional view showing another configuration example of the container according to the present invention.

FIG. 15 is a bottom view of the container shown in FIG.

FIG. 16 is a longitudinal sectional view showing another configuration example of the container in the present invention.

FIG. 17 is a bottom view of the container shown in FIG.

FIG. 18 is a longitudinal sectional view showing another configuration example of the container according to the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 1A Syringe 2 Outer cylinder 2a Bottom part 2b Rear end opening 2c Flange 3 Projection part 31 Tube 32 Sealing member 321 Solid columnar part 322 Breakage part 4 Tube 5 Needle tube 51 Needle tip 6, 6A Connection part 61 Male screw 7 Encapsulation Member 8 Film 81 Tab 10, 10A, 10B Container 11 Container main body 111 Tip opening 112 Protrusion 113 Bottom inner surface 114 Tip edge 115 Rib 12, 12A Gasket 121 Tip surface 122 Rear end surface 123 Outer peripheral surface 13 Space 14 Thin portion 15 Space 16 , 16A Locking portion 161 Space 162 Opening 163 Locking surface 164 Female screw 17 Vent hole 18 Projecting portion 19 Film 20 Gasket 21 Space 22 Thin portion 23 Core material 231 Body portion 24 Space 25 Locking portion 26 Female screw 27 Small piece 28 Locking member 29 Inner diameter enlarged part 30A, 30B, 30C Gripping part Material 300 Engaging part 301, 302 Flange 303 Shaft 304 Depression 100 Bag 101 Bag main body 102 Opening 103 Elastic plug 104 Fusing part 105 Hanger 106 Infusion 108 Chemical liquid 120 Chemical

──────────────────────────────────────────────────続 き Continuation of front page (72) Inventor Junji Kimura 1500 Inoguchi, Nakai-machi, Ashigara-gun, Kanagawa Prefecture Inside Terumo Corporation (56) References JP-A-4-2311051 (JP, A) JP-A-2-99065 (JP) , A) Hikaru 4-32736 (JP, U) (58) Fields investigated (Int. Cl. ⁷ , DB name) A61J 1/05 A61J 1/10 A61J 1/14 A61M 5/162

Claims (9)

(57) [Claims] 1. A bag assembly comprising: a bag in which a syringe is fixed to a flexible bag body so as to protrude inside the bag body in a liquid-tight manner; and at least one container to be loaded in the syringe. In the syringe, an outer cylinder, a tube installed in the outer cylinder,
A projecting portion communicating with one end of the tubular body and projecting from the bottom of the outer cylinder into the bag body; and a sealing member for sealing at least a part of a flow path from the tubular body to the inside of the projected portion. A needle tube installed on the other end side of the tube, and a connecting portion formed on an outer peripheral portion of the needle tube, wherein the container has a bottomed cylindrical container body, and an inner surface of the container body. A gasket slidable in a liquid-tight manner along the gasket, wherein the gasket is formed with a thin portion through which the needle tube can be pierced, and a locking portion with which the connecting portion locks. Along with releasing the sealing of the flow channel by the member, inserting the container into the outer cylinder from the gasket side, piercing the needle tube into a thin portion of the gasket, and the connecting portion and the locking portion. With the container locked, the container body is axially opposed to the syringe. By moving the bag assembly, wherein the liquid is injected in at least the container into the bag body. 2. The bag assembly according to claim 1, wherein the inside of the container is evacuated. 3. The bag assembly according to claim 1, further comprising regulating means for regulating an axial position of the gasket with respect to the container body. 4. The bag assembly according to claim 1, further comprising a film for sealing an opening of the container body. 5. The bag assembly according to claim 1, wherein the gasket can reciprocate in the container body by locking the locking portion and the connecting portion. 6. The bag assembly according to claim 1, further comprising a covering member that covers the needle tube and can be pierced by a second needle tube. 7. The bag assembly according to claim 1, wherein the syringe is fixed to an edge of the bag body. 8. The bag assembly according to claim 1, wherein a liquid is contained in the bag body. 9. The bag assembly according to claim 1, wherein a plurality of containers each containing a medicine having a different component are exchanged and used.