JP3355426B2 - Infusion container - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an infusion container, and more particularly to an infusion container provided with a communication means capable of communicating with another medicine container and a medicine outlet.

[0002]

2. Description of the Related Art Conventionally, dry preparations such as powdered preparations, freeze-dried preparations, and solid preparations sealed in drug containers such as glass vials have been separately stored at the medical site such as a hospital at the time of use. They have been mixed or dissolved or diluted with a solution or diluent such as water, physiological saline, or glucose solution, and administered to patients. The preparation of such a drug has been carried out mainly by mixing and dissolving it using a communicating device such as a syringe, a double-ended needle or a special connecting tube.

However, in the above-mentioned method, since the operation is complicated and time-consuming, and there is a risk of bacterial contamination during the operation, for example, a vial containing an antibiotic which is unstable over time,
A container in which a flexible plastic container containing a dissolving solution is integrally combined via a puncture needle has been developed (for example, see Japanese Patent Publication No. 5-72830).

[0004] This container has the advantage that the mixing operation can be performed easily and aseptically, but at the time of disposal, it takes a lot of time to separate the glass vial, the flexible container and the communication device, and the disposal process Therefore, there has been a problem that the demand for easy disposal of medical waste, which is currently being highlighted, cannot be satisfied. In addition, this container has a large number of parts, so that the manufacturing cost is high. In addition, since the number of discarded parts is large, it is hard to say that it is preferable for a medical site where a large amount of cost is required for disposal of used medical devices.

As an infusion container capable of solving the above problem, an infusion container having a configuration in which the number of parts is small without containing a medicine container such as a glass vial has been developed (for example, see Japanese Patent Application Laid-Open No. Hei 5-337163).

However, since the double-ended needle, which is a communicating tool, is not completely fixed in the structure of the infusion container, the operation for communicating with the drug container or the dissolving solution container may not be performed smoothly.

In addition, the above-mentioned infusion container uses a communicating tool composed of a double-ended needle, and one of the puncturing needles has a rubber stopper or a rubber stopper provided at a communicating port of a flexible container in which a solution or the like is sealed. The closure membrane was punctured, and the other was punctured into the mouth of a drug container such as a glass vial in which an antibiotic or the like was sealed.

The present invention has been made to eliminate such a conventional problem.

[0009]

SUMMARY OF THE INVENTION The present invention relates to a flexible plastic container body in which a chemical such as a dissolving solution or a diluting liquid is sealed. In the infusion container provided with an outlet, the communicating means is connected to the inside of the container main body and is capable of piercing the mouth of another drug container, and is integrally combined with the puncture needle concentrically. The puncture needle is covered with a protective cap having a rubber inner layer made of a rubber member. The rubber inner layer of the cap forms a seal around the puncture needle to keep the puncture needle in a sterile and liquid-tight state, and between the protective cap and the communicating means, a restraint for restraining the protective cap in a crowned state. A mechanism is provided, Structure is by rotation of the protective cap, according to the infusion container, characterized in that it is configured to be taken selectively a restricting position and a non-restraining position.

In the present invention, the flexible plastic container body is formed of a plastic material having excellent flexibility such as a polyolefin resin such as polypropylene and polyethylene, a soft vinyl chloride resin and an ethylene-vinyl acetate copolymer. A drug solution such as distilled water for injection, glucose, physiological saline, an electrolyte solution, an amino acid solution, or a fat emulsion is sealed in the inside.

[0011] Examples of other drug containers include glass vials and the like, in which, for example, antibiotics, anticancer drugs,
Hygroscopic properties of steroids, thrombolytics or vitamins,
An easily oxidizable and easily denatured powder is enclosed.

The material of the puncture needle and the supporting member as the communicating means is not particularly limited as long as it has good chemical resistance, and for example, a polyolefin resin such as polypropylene or polyethylene is used.

The protective cap covered by the puncture needle comprises a cap main body and an inner layer made of a rubber member laminated and integrated on the entire inner surface of the main body.

The cap body is preferably formed of a plastic resin material such as polypropylene, polyethylene, polystyrene, polycarbonate, etc., and particularly preferably a hard one is used.

The rubber inner layer is for maintaining the sterility of the puncture needle and the hermeticity of the drug solution, and is made of a material having good chemical resistance, such as natural rubber, isoprene rubber, butadiene rubber, and styrene. -Butadiene rubber,
It is composed of rubber members such as nitrile rubber, urethane rubber and silicone rubber, or rubber members such as olefin-based, urethane-based and styrene-based elastomer resins. In addition, as means of lamination integration of the cap body and the rubber inner layer,
For example, there is a bonding means using a fitting or an adhesive, or an integral molding by insert molding, two-color molding or the like.

[Operation] According to the infusion container of the present invention, the sterility of the puncture needle and the hermeticity of the drug solution can be normally maintained by the rubber inner layer provided on the protective cap. In one use, the protective cap is rotated after a predetermined angle and released from the restraining mechanism, then removed, and then the puncture needle is inserted into the mouth of another drug container to perform internal communication between the infusion container and the other drug container, Thereafter, by introducing the drug solution in the infusion container into the other drug container through the puncture needle with the other drug container facing down, the mixing and dissolution of the drug and the drug solution, and thus the drug solution adjustment can be performed.
The adjusted drug solution can be administered to a patient by connecting an infusion set or the like to a drug solution outlet of the infusion container.

[0017]

DESCRIPTION OF THE PREFERRED EMBODIMENTS One embodiment of the present invention will be described below with reference to the accompanying drawings.

FIG. 1 shows an entire infusion container according to an embodiment of the present invention.

In this embodiment, the infusion container has a bag-type flexible plastic container main body 1, and the container main body 1 is formed by applying heat sealing means around a double-layered flexible plastic film, for example. To form the peripheral seal 1a.

A chemical solution 2 such as a dissolving solution or a diluting solution is sealed in the container body 1, and an infusion set is applied to an appropriate location in the peripheral portion, for example, a lower end, to perform infusion of the infusion solution. The chemical liquid outlet 3 is provided at the upper end with a communicating means 4 capable of communicating with another chemical container a (see FIG. 8) such as a glass vial.

As shown in the exploded view of FIG. 2, the communication means 4 supports a hollow puncture needle 5 capable of piercing the mouth b of another medicine container a and another medicine container a at the time of communication. The puncture needle 5 has a tubular portion 7 connected to the proximal end side of the puncture needle 5.

As shown in FIG. 1, the tubular portion 7 is sandwiched and fixed between the front and rear films constituting the peripheral seal 1a of the container main body 1 by applying a welding means or the like, and the puncture needle 5 is connected to the container main body 1. It has both a communicating part communicating with the inside and an attaching part for further attaching the communicating means 4 to the container body 1 integrally.

The puncture needle 5 is formed using, for example, a plastic, especially a hard material. FIG. 3 shows the puncture needle 5 having three through holes 5a near the distal end, but the shape of the needle and the number of through holes 5a are not particularly limited.

The support member 6 is made of, for example, plastic, and can be formed integrally with the puncture needle 5 by applying injection molding means or the like.

The support member 6 may be of any shape that can sufficiently support the medicine container a when communicating with another medicine container a. For example, as shown in FIG. A shape close to the above shape, especially a bowl-shaped shape whose inner diameter is enlarged toward the top, is suitable.

The puncture needle 5 is integrally held at the center of the bottom 6a of the support member 6, and the upper end of the puncture needle 5 ends slightly before the upper end of the support member 6.

The puncture needle 5 of the communication means 4 is provided with a protective cap 8 for keeping the puncture needle 5 sterile and liquid-tight until use.

The protective cap 8 has a sheath-shaped plastic cap body 8a and a rubber inner layer 8b made of a rubber member laminated and integrated on the entire inner surface of the body 8a.

In the crowned state, the inner diameter of the inner space 8c of the cap 8 is adjusted so that the entire inner surface of the rubber inner layer 8b of the protective cap 8 is in close contact with the entire outer surface of the puncture needle 5. The diameter is set to be substantially equal to or slightly smaller than the diameter.

The rubber inner layer 8b of the protective cap 8 may be integrally fitted and connected to the cap body 8a, or may be integrally formed by integral molding.

A restraining mechanism 9 is provided between the cap 8 and the support member 6 in order to restrain the protective cap 8 in a crowned state.

As shown in FIGS. 4 and 5, the restraining mechanism 9 includes a pair of engaged portions 9a, 9a arranged at 180 ° intervals and protruding outward from a part of the outer peripheral surface of the lower end of the protective cap 8. A pair of engaging portions 9b, 9b protruding inward from a part of the inner peripheral surface of the lower end portion of the body portion 6b of the support member 6;
The gaps 9c and 9 are provided between the base 9b and the bottom 6a of the support member 6.
c is formed. The gaps 9c, 9c
The engaging portions 9a, 9a enter the lower surfaces of the b, 9b from outside and engage with the engaging portions 9b, 9b.

When the restraining mechanism 9 is in the non-restrained state as shown by the imaginary line in FIG. 5, the engaged portions 9a, 9a
b, 9b.

In the state shown in FIG. 5, when the protective cap 8 is rotated by a predetermined angle, for example, 90 °, the engaged portions 9a move in the rotational direction from the position shown by the imaginary line with the rotation, and the gap 9
c, 9c from the outside, and occupies a restrained position coinciding with the engaging portions 9b, 9b as shown by a solid line in FIG.

In this restrained position, the engaged portions 9a,
The upper surface of 9a is engaged with the lower surfaces of the engaging portions 9b, 9b, and restrains the protective cap 8 in a crowned state.

The engaged portions 9a, 9a and the engaging portions 9b, 9b
In the drawing, a case is shown in which a pair of flat fan-shaped ones are provided, but the plane shape and the number of formed members are limited as long as they have a configuration that can selectively take a constrained position and a non-constrained position. There is no particular limitation.

FIG. 5 shows a range of angles that can be held in the restrained state.
However, if the angle range is too large, it is inconvenient to remove the protective cap 8, and
If the size is too small, the holding of the restraint becomes unstable.
A suitable angle is about {80}.

[0038] Incidentally, among the bottom 6a of the supporting member 6, the portion 6a ₁ located immediately below the engaging portion 9b, 9b considers demolding during injection molding, are opened.

The support member 6 has a pair of ears 10 and 10 opposed to each other with the center therebetween at the outer peripheral portion of the upper end.
At 0, the hanging tool 11 (see FIG. 1) is supported.

In order to form a seal around the puncture needle 5 in the state where the protective cap 8 is covered, as shown in FIGS. 2 and 3, on the upper surface of the bottom surface 6a of the support member 6, concentrically with the puncture needle 5 and A ring projection 12 is formed at a position corresponding to the lower surface of the rubber inner layer 8b of the protective cap 8.

When the protective cap 8 is restrained by the crown, the ring projections 12 engage with the lower surface of the rubber inner layer 8b as shown in FIG. Then compress and deform.

As shown in FIG. 6, the rubber inner layer 8b is enlarged.
Upset 8b ₁ of the one hand ring ridges 12
To form a seal 13, and on the other hand, push up the engaged parts 9 a, 9 a via the protective cap 8 to raise the engagement part 9.
b, 9b to be pressed and engaged with the lower surface.

Instead of providing the ring ridge 12, as shown in FIG. 7, the lower end of the rubber inner layer 8b is projected downward from the lower end of the cap body 8a, and this projection 14 is held when the protective cap 8 is restrained by the crown. A configuration in which compression deformation is performed against elasticity may be employed. Ring ridge 12 and protrusion 1
4 may be used together in some cases.

FIG. 4 shows a normal state of the infusion container of the present invention. In the normal state, the lower end of the protective cap 8 and the bottom 6a of the support member 6 are enlarged as shown in FIG.
A seal 13 composed of the rubber inner layer 8b compressed and deformed by the ring ridge 12 is formed between the puncture needle 5 and the puncture needle 5 is maintained in a sterile and liquid-tight state by the action of the seal 13.

Further, on the base end side of the distal end opening 5a of the needle hole of the puncture needle 5, the inner peripheral surface of the rubber inner layer 8b of the protective cap 8 is completely in close contact with the outer peripheral surface of the puncture needle 5, so that the distal end opening Chemical solution 2 flowing from 5a to seal 13 (see FIG. 1)
Can be prevented, and the outer peripheral surface of the puncture needle 5 can be kept in a dry state, that is, a state not wet with the chemical solution 2 until use.

Further, between the engaged portions 9a, 9a constituting the restraining mechanism 9 and the engaging portions 9b, 9b, the rubber inner layer 8 is provided.
Since b crimping engagement undergoing upward force of the compressive deformation portion 8b ₁ of the occurs, normal eg transportation, engaged portion 9a even under vibration during storage, 9a is rotated displaced engagement Joint 9
The protective cap 8 can be stably and reliably restrained in the crowned state without the danger that the protective cap 8 will come off the b and 9b.

[0047] In use, the protective cap 8 rubber inner layer 8b, especially depressing against the holdings elastic compressive deformation portion 8b _1, the engaged portion 9a, 9a is released from the crimped to the engaging portion 9b, 9b Therefore, the protective cap 8 can be easily removed by pushing down the protective cap 8 and rotating it by a predetermined angle to release it from the restraint of the restraining mechanism 9.

After removing the protective cap 8, as shown in FIG. 8, the puncture needle 5 is inserted into the mouth b of the other medicine container a to connect the container body 1 of the infusion container with the other medicine container a. Internal communication is performed, and thereafter, the other drug container a is turned down, and the drug solution 2 in the container main body 1 of the infusion container is introduced into the other drug container a through the puncture needle 5 to mix and dissolve the drug and the drug solution. As a result, the chemical solution can be adjusted. The adjusted drug solution can be administered to a patient by connecting an infusion set or the like to the drug solution outlet 3 provided in the container body 1 as usual.

After the administration of the drug solution, it is divided into three parts, namely, the container body 1, the protective cap 8 and the other drug container a, and discarded.

[0050]

According to the infusion container of the present invention, the following effects can be obtained.

(A) Parts are the container body and the protective cap
Since it is a part and the number of parts is small, the manufacturing cost is low and it can be provided at a low price.

(B) The puncture needle is communicated in advance in the infusion container, and since there is no seal between the puncture needle and the sealing member such as a rubber stopper and an obstruction film as seen in the conventional product, foreign matter during the communication operation is not present. The risk of contamination can be reduced.

(C) Since the puncture needle is communicated in advance in the infusion container, the operation for communication is simple and time-consuming, and the burden on the operator can be reduced. Further, since the communication operation is simple, there is no room for erroneous operation, and the mixture can be aseptically mixed and dissolved.

(D) The puncture needle is fixed to the container body of the infusion container, and a support member for another medicine is provided around the puncture needle, so that the connection operation with another medicine container can be stably and reliably performed. It can be carried out.

(E) In the crown cap restrained state of the protective cap, the rubber inner layer provided on the cap is compressed and deformed to form a seal at an appropriate position around the puncture needle. The needle can be stably and reliably maintained in a sterile and liquid-tight state until use.

[Brief description of the drawings]

FIG. 1 is a partially cutaway front view showing one embodiment of the present invention.

FIG. 2 is a longitudinal sectional view showing a puncture needle of a communicating means with a protective cap removed.

FIG. 3 is a plan view of a communication unit.

FIG. 4 is a longitudinal sectional view showing a state in which a protective cap is captively constrained on a puncture needle of the communication means.

FIG. 5 is a plan view of FIG. 4;

FIG. 6 is an enlarged view showing a state of formation of a seal.

FIG. 7 is a longitudinal sectional view showing a seal forming means instead of a ring ridge.

FIG. 8 is an explanatory diagram showing a state of internal communication with another medicine container.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Container main body 2 Chemical liquid 3 Chemical liquid outlet 4 Communication means 5 Puncture needle 6 Support member 7 Tubular part 8 Protective cap 9 Restraining mechanism 10 Ear part 11 Hanging tool 12 Ring protrusion 13 Seal 14 Rubber inner layer protrusion

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-6-54889 (JP, A) JP-A-6-7409 (JP, A) JP-A-8-24316 (JP, A) 86536 (JP, U) Japanese Utility Model 4-71939 (JP, U) (58) Field surveyed (Int. Cl. ⁷ , DB name) A61J 1/05 A61J 1/10

Claims (5)

(57) [Claims] An infusion container having a flexible plastic container body in which a chemical such as a solution or a diluent is sealed, and a communication means for communicating with another medical solution container and a chemical solution outlet. A puncture needle that communicates with the inside of the container body and can puncture the mouth of another drug container, and is integrally and concentrically combined with the puncture needle, and connects the other drug container during communication. The puncture needle is covered with a protective cap provided with a rubber inner layer made of a rubber member.In this crowned state, the rubber inner layer of the protective cap is formed of the puncture needle. A seal is formed around the puncture needle to hold the puncture needle in a sterile and liquid-tight state, and between the protective cap and the communicating means, there is provided a restraining mechanism for restraining the protective cap in a crowned state, and the restraining mechanism includes: Rotation of the protective cap The infusion container, characterized in that it is configured to obtain selective to take a restrained position and a non-restraining position. 2. A restraining mechanism comprising: at least two engaged portions projecting outward from a part of an outer periphery of a lower end portion of a protective cap;
The support member includes at least two engaging portions that protrude inward from a part of the inner periphery of the lower end portion and can be engaged with the engaged portion in the up-down direction.
The infusion container according to claim 1, wherein the infusion container is configured to be able to selectively take an engagement position for engaging with the engagement portion and a non-engagement position for disengaging from the engagement portion. 3. The infusion container according to claim 1, wherein the support member has a bottom portion for receiving a lower end of the protective cap in a captive restrained state. 4. A ring projection concentric with the puncture needle is formed on the upper surface of the bottom of the support member, and the ring projection is formed so as to form a seal with the lower end face of the rubber inner layer of the protective cap in a crown-restricted state. 4. The method according to claim 3, wherein
An infusion container as described. 5. An inner rubber layer of the protective cap is projected downward from a lower end of the cap, and the projected portion is configured to be compressed and deformed by the bottom of the support member to form a seal when the protective cap is restrained by the crown. The infusion container according to claim 3 or 4, wherein: