JPH05111524A - Medical kit product - Google Patents

Abstract

PURPOSE:To provide a medical kit product having a connector section which has an excellent sealing capability and excellent easiness for operation at the time of connection, does not break a connector at the time of connection, mixes no impurity into a chemical, and has excellent safety for improving the performance of the connector indispensable for the kit product. CONSTITUTION:A connector section 10 made of a separate member is provided between storage chambers 3, 4 of a soft bag 1, a passage traverse hole section 12 in the perpendicular direction to a communicating passage 11 is provided, a moving core 14 made of butyl rubber and provided with a through hole 13 in the direction of the passage 11 is inserted into the passage traverse hole section 12, the knob 15 of the moving core 14 protruded to the outside of the hole is rotated to rotate the core 14, thus the passage 11 is communicated via the through hole 13.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an injectable medical kit product in which a drug and an administration system are combined, and a connector portion which serves as a drug passage for mixing a plurality of drugs which are separately sealed and stored in a container until use. According to the improvement of 1., a movable core that shields a passage having a predetermined shape or an introduction passage provided between storage compartments from the outside and is rotatable from the outside of the bag is arranged, and the through hole is provided in the core by rotating the core. The storage compartments that were separated and shut off at the position of are connected to each other. The present invention relates to a medical kit product having a highly safe connector portion that does not mix impurities.

[0002]

2. Description of the Related Art Medical kit products are in the form of injections that combine a drug and an administration system. In Japan, the Pharmaceutical Affairs Council also reports on the handling of kit products (1986, 1986).
3. After the drug trial No. 98) was issued, attention has been paid and various configurations have been proposed.

When a glucose solution as an infusion solution and an amino acid preparation are mixed and stored, there is a risk of deterioration or discoloration.
Usually, it is common to mix various drugs at the time of use so that these two liquids are mixed at the time of use. In addition, injectable antibiotics have a basic dosage form of intravenous infusion, and since many antibiotics are soluble before use, they require two operations, redissolving and mixing, at the time of administration. Medical problems such as long time are required.

Therefore, there has been a long-felt demand for a kit product which can be easily mixed by separately storing the soluble preparation and the dissolving solution in the same container and performing a simple connecting operation to the connector portion at the time of use. ..

For example, a needle for introducing a drug by piercing a rubber stopper of a vial at one end on the bag side in order to mix a ready-to-use dissolution type formulation in a glass vial or a plastic bottle with a solution in a soft bag. A kit product having a structure in which a tapping portion is provided on the other end of the needle in the bag and a breakable connector that opens by breaking the portion and opens the same is proposed (JP-A-61-501129). , JP-A-1
-94856).

Further, a kit product is proposed in which a connector portion having a double-ended needle is arranged, and the diaphragm or the rubber stopper in the soft bag and the rubber stopper of the vial are pierced to communicate between both drug storage chambers (JP Sho 63-139555
No. 2-1277).

Among the constitutions in which the inside of the soft bag is divided into a plurality of storage chambers and the connectors are arranged between the storage chambers and the same portion is opened at the time of use, a breakable connector which breaks the tapping portion and opens it Possession (Japanese Patent Laid-Open No. 63-11
No. 161), which has a clamp-type connector for blocking the passage by a pressing force from the outside of the bag by using various clips which are fitted in concavo-convex (Japanese Utility Model Publication No. Sho 63-20550, Japanese Patent Laid-Open No. Sho 6-20550).
No. 3-309263, No. 64-54547, No. 1-135940, and those with a needle-type connector that pierces and communicates with a sealing diaphragm with a hollow needle (Japanese Patent Publication No. 63-20550). ..

[0008]

The above kit product is
For example, since it is sealed and stored in the same bag until the time of use, the risk of microbial contamination such as drugs can be reduced, and the drugs to be mixed are separately stored in the same bag.
There are various advantages such as the prevention of errors during the dispensing of medication and the quick response in case of emergency.

However, such various advantages are related to the performance of the connector part for introducing the drug from the vial and the connector part provided between the storage chambers by partitioning the inside of the soft bag. For example, the clamp type connector is used. There is a problem that the sealing ability up to that time is inferior, the needle-type connector and the breakable connector that pierce and communicate with the diaphragm with a hollow needle or the like are inferior in the workability of releasing, and that fragments and the like are suspended in the drug.

It is an object of the present invention to provide a kit product having various forms such as a mixed bag type of 2 liquid or 3 liquid, a mixed type of liquid or powdered drug and a drug in the bag. Since the performance of the connector, which is indispensable for kit products, is improved, the sealing performance is excellent, the operability during communication is excellent, the connector is not broken during communication, and the safety that does not mix impurities into the chemical solution is excellent. It is intended to provide a medical kit product having a connector portion.

[0011]

SUMMARY OF THE INVENTION The present invention relates to an injectable medical kit product comprising a soft bag in which medical drugs are separately stored and combined with a mixing and administration system, which are provided for communication in a soft bag. At least a soft bag is provided with a connector portion having a passage crossing hole portion provided for a passage, and a movable core capable of shielding the passage passage and having a through hole in the passage direction rotatably fitted in the passage hole portion. It is a medical kit product characterized by being arranged at one location.

[0012]

In the medical kit product according to the present invention, the passage portion having the predetermined shape is provided in the connector portion provided in the predetermined passage or the introduction passage provided between the storage compartments of the soft bag and the passage portion is crossed. A structure is provided in which a movable core rotatable from outside the bag is fitted in the hole, and the movable core is rotated to communicate between the storage compartments that are separated and blocked at the position of the through hole in the passage direction provided in the core. By arranging the new connector, it has excellent shut-off characteristics between storage compartments and operability at the time of communication, does not break the stopper member at the time of communication, and does not mix impurities into the chemical solution. It is excellent in safety and can be easily applied to various types of kit products as is apparent from the examples, and satisfies all the properties required for the connector section.

In the present invention, in order to make the movable core of the connector part rotatable, various forms can be used. For example, as shown in the embodiment, the passage crossing hole end is located at the soft bag peripheral end. The end of the movable core is projected outside the hole, and the end is molded into a T-shape so that the end can be easily rotated. In addition, the connector is provided in the center of the soft bag to A structure in which both ends are bent into an L shape to be exposed to the outside of the bag, and the movable core is rotated by raising the exposed ends as levers. Also, holes are provided in the exposed core ends to provide a rod or a ballpoint pen tip. To move the movable core by rotating the movable core, and further to sharpen the inner end of the transverse hole of the movable core to facilitate positioning during rotation,
Various configurations such as a configuration in which the shape of the movable core is changed from a cylindrical shape to a prismatic shape and the movable core is fitted into the circular transverse hole portion can be adopted.

In the present invention, the form of the connector portion is appropriately selected according to the use, shape, arrangement position, etc. of the passage provided in the soft bag. Particularly, the crossing angle of the passage crossing portion with respect to the passage, the shape of the crossing hole, Since the dimensions have a great influence on the passage blocking performance, the ease of rotation and opening operation by the movable core that fits into the transverse part, the materials used for the soft bag, the passage transverse part and the movable core, the finished surface roughness of each part, the assembly and welding. It is necessary to select it appropriately according to the method of integration. In addition, the movable core makes contact with the inner surface of the hole on the entire outer circumference of the core in the passage crossing part, and also makes contact with the single or a plurality of seal ring parts protrudingly formed on the outer circumference of the core to ensure rotatability in the hole It is advisable to select it appropriately in consideration of hermeticity.

Polyethylene (P
E) type and polypropylene (PP) type are often used, but the required communication passages, passage crossing parts and movable cores are made of the same material as the soft bag and of high hardness, and also known for medical kit products. Other synthetic resins and rubber materials such as butyl rubber can be appropriately selected.

The connector portion according to the present invention is assembled by a separate member from the communication passage provided in the soft bag or integrated by heat welding, and also shown in the embodiment depending on the use, shape, arrangement position, etc. of the passage. As described above, the passage and the passage crossing portion are formed by injection molding as the same member, and a rod-shaped movable core having a through hole having the same passage hole shape as the communication passage is fitted into the passage crossing hole portion. It is suitable for industrial production that it is placed at a required position and sealed by heat welding.

[0017]

【Example】

Example 1 FIG. 1 shows an example in which a medical kit product according to the present invention is configured as a two-liquid mixing soft bag. The soft bag 1 made of PP has a hole 2 for suspension support in the head, and two storage chambers 3 and 4 are arranged on the upper and lower sides of the body, and the connector portion 10 is provided between the storage chambers 3 and 4.
Further, a rubber stopper 5 for piercing a needle of an infusion set for administering the mixed drug is provided at the lower end.

As shown in FIG. 2, the connector portion 10 has a P
It is configured by a separate member made of P, and a passage crossing hole portion 12 having a circular cross section is provided in a direction orthogonal to the circular passage 11 for communication in the vertical direction. A butyl rubber movable core 14 having a through hole 13 is fitted in the passage crossing hole portion 12. The tip of the movable core 14 inside the passage crossing hole portion 12 is rounded and sharpened, and similarly, the inside of the passage crossing hole portion 12 is also shaped like a mortar to form the movable core 1.
4 is configured so that the positioning and smooth rotation can be obtained when rotating. In addition, the end of the passage crossing 12 is a soft bag 1.
The knob 15 is formed at a peripheral end so that the end of the movable core 14 is projected out of the hole, and the end is molded into a T-shape so that it can be easily rotated by a finger.

In the above structure, the elliptical passage 11 of the connector portion 10 is blocked by the movable core 14, the medicines in the storage chambers 3 and 4 are completely separated and stored, and the movable portion in the passage crossing hole portion 12 is movable. Here, the core 14 is in close contact with the outer peripheral surface of the core and the inside of the hole, the connector portion 10 is completely sealed, and the atmosphere and the invasion of bacteria from the outside are completely prevented.
Allows long-term storage.

Further, when the knob 15 is rotated by 90 ° in the connector portion 10 to rotate the movable core 14 at the time of required administration, the position of the through hole 13 is easily moved to communicate with the circular passage 11, for example, When the soft bag 1 is suspended, the in-use dissolution type formulation in the storage chamber 3 is dropped and introduced into the dissolution liquid in the lower storage chamber 4.

In the example of FIG. 1, an example in which two liquids are mixed vertically is shown, but similarly, a three-liquid mixing type soft bag in which storage chambers for three liquids are arranged above and below via a connector part is constructed. You can

Example 2 FIG. 3 shows an example in which the medical kit product according to the present invention is configured as a three-liquid mixing soft bag. The soft bag 1 having the same configuration as in Example 1 is used, and the upper storage chamber is 2 The chambers are divided into storage chambers 3a and 3b, and a connector portion 10 similar to that of the first embodiment is arranged between the storage chambers 4 and the storage chambers 4, respectively.

The connector portion 10 has exactly the same construction as that described in detail in the first embodiment, and the end portion of the movable core 14 is formed so that the knob 15 is formed so as to be exposed from the peripheral end of the soft bag 1. The connector portion 10 is completely sealed, the atmosphere and the invasion of bacteria from the outside are completely prevented, and it is possible to store it for a long time. At the time of required administration, knob 1
The elliptical passage 11 can be opened by turning 5 to rotate the movable core 14 a quarter turn.

Example 3 FIG. 4 shows an example in which the medical kit product according to the present invention is configured as a soft bag for mixing two liquids with a vial. The soft bag 6 is provided with a storage bag 7 for a solution or the like and a bag part 8 for a vial so that the upper part of the suspension support hole 2 side is opened so as to enter the middle of the storage bag 7. A connector portion 20 is arranged between the bottom of the housing 8 and the storage chamber 7.

The connector portion 20 is a member separate from the soft bag 6, and has a passage crossing hole portion 22 having a circular cross section in a direction orthogonal to a circular passage 21 for communication in the vertical direction. A movable core 24 made of butyl rubber having a columnar shape and a through hole 23 in the direction of the circular passage 21 provided at a required position is fitted in the passage crossing hole portion 22. Also, the bag part 8 for the vial
The circular passage 21 is a needle portion 25 that can be pierced through the rubber stopper of the vial. Further, the end of the movable core 24 is exposed by arranging the end of the passage crossing hole 22 at the peripheral end of the soft bag 6 to form a T-shaped knob 26.

The circular passage 21 including the needle portion 25 of the connector portion 20 is blocked by the movable core 24 during storage, and the passage crossing portion 22 is sealed by the movable core 24, so that the atmosphere and the invasion of bacteria from the outside are completely eliminated. Therefore, the drug in the storage chamber 7 can be stored for a long period of time. Also, the bag part 8 for the vial
The needle portion 25 can be prevented from being contaminated by constructing a structure in which the opening can be sealed with a chuck until use. At the time of use, first, the rubber plug of the vial 9 is pierced by piercing the needle portion 25, and then the knob 26 of the movable core 24 is turned to rotate the movable core 24 by a quarter, so that the through hole 23 is easily formed. The medicine in the vial 9 can be introduced into the storage chamber 7 by moving to the position of the circular passage 21 and communicating with each other.

Although not shown, the needle portion 25 in the vial bag portion 8 can be used as a mixture with a powdered medicine by replacing it with a funnel-shaped one.

[0028]

According to the present invention, the connector portion having the movable core which crosses the passage having a predetermined shape or the introduction passage provided between the storage compartments of the soft bag and which is rotatably fitted from the outside of the bag is arranged. By turning the core to connect the storage compartments that have been separated and cut off at the position of the through-hole provided in the core, the shut-off characteristic between the storage compartments,
It has excellent operability during communication, does not break the tapping member during communication, and does not have impurities such as mixing impurities in the drug solution. It also mixes two liquids, mixes with vials, and powders. It is a medical kit product having a connector section with excellent versatility that can be applied to various forms of kit products such as mixed products.

[Brief description of drawings]

FIG. 1 is a partially cutaway explanatory view of a medical kit product according to the present invention configured as a two-liquid mixing soft bag.

FIG. 2 is a perspective explanatory view showing a configuration of a connector portion of the present invention.

FIG. 3 is a partially cutaway explanatory view of a medical kit product according to the present invention configured as a three-liquid mixing soft bag.

FIG. 4 is a partially broken explanatory view of a medical kit product according to the present invention configured as a soft bag for mixing two liquids with a vial.

[Explanation of symbols]

 1,6 Soft bag 2 Suspension support hole 3,3a, 3b, 4,7 Storage chamber 5 Rubber plug part 8 Bayer bag part 9 Bayer 10,20 Connector part 11,21 Circular passage 12,22 Passage passage hole portion 13 , 23 Through hole 14, 24 Movable core 15, 26 Knob 25 Needle part

Claims (1)

[Claims] 1. An injectable medical kit product comprising a soft bag in which medical agents are separately stored and combined with a mixing and administration system, and a passage crossing hole is provided for a communication passage arranged in the soft bag. And a connector portion configured to rotatably fit a movable core having a through hole extending in the passage direction and capable of shielding the passage in the transverse hole portion is disposed at at least one location of the soft bag. Characteristic medical kit products.