JP2001299912A - Injection kit and injection apparatus - Google Patents

Abstract

PROBLEM TO BE SOLVED: To execute the preparation of an injection solution with a simple mechanism and operation even under a non-clean environment while minimizing the opportunity of infection, directly inject the prepared injection solution to a patient through an injection needle set in a soft bag, and minimize the number of materials necessary for the preparation of the injection solution to facilitate the management of medicines. SOLUTION: In this injection kit, the manufacturing method of this injection kit, and the injection apparatus effectively usable of this injection kit, a cylindrical flexible vessel (soft bag) made of a plastic double layer film is partitioned into 2-4 chambers by at least one easily releasable and fusible partition wall 1. The first chamber is provided with a nozzle-like injection solution outlet 2 and filled with a solid 4 medicine A, and the tail chamber is filled with a dissolving solution B for dissolving the solid medicine. A metallic injection needle 3 is installed to the nozzle-like injection solution outlet 2 disposed on the first chamber, and a plastic protecting cap 4 is put on the injection needle 3 before use.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates firstly to an injection kit.

More specifically, a plastic flexible container (soft bag) is divided into two chambers by an easily peelable partition, and one chamber is filled with a small amount of a solid drug, for example, about 0.5 to 3 g, In the other room, for example, about 1
It is filled with 20 ml of the dissolution solution, and further, a nozzle-shaped injection solution outlet is provided at one end of the solid medicine chamber, and a metal injection needle is attached to the outlet. After the injection solution is prepared, the solution is directly injected into the patient. To an injection kit that is capable of In addition,
If necessary, the soft bag can be divided into three or four chambers by an easily peelable partition (described later).

[0003] The present invention also provides a solid drug chamber of a soft bag and a metal injection needle with a cap in order to prevent the solid drug filled in the soft bag of such an injection kit from being absorbed and deteriorated. Collectively cover with a sheath-shaped bag for the purpose of moisture proofing, and the lower edge of the bag is the partition wall between the solid drug chamber and the solution chamber made by easy peeling welding of the soft bag. It relates to keeping airtight by welding or bonding.

[0004] The above-mentioned sheath-shaped bag for the purpose of moisture prevention is made of a multilayer film composed of a gas-barrier transparent plastic film and a soft low-melting-point plastic film, or between the multilayer film. Applying or adhering a desiccant to the extent not obstructing the observation of the condition of the desiccant, encapsulating the powder of the desiccant, or inserting a layer containing paper containing the desiccant, Using a multilayer film in which a part of the barrier transparent plastic film is replaced with a metal foil to the extent that it does not hinder observation of the state in the moisture-proof sheath-shaped bag, and welding a soft low-melting plastic film as the inner surface It can be created by bag making. When a desiccant is used, it may be arranged in a space between the sheath-shaped moisture-proof bag and the part of the injection kit covered by the moisture-proof bag instead of being arranged between the two layers of the multilayer film.

[0005] The moisture-proof bag made as described above and welded or adhered to the injection kit is peeled off when the injection kit is set in the injection device of the present invention described later.

The present invention secondly relates to an injection device.

In more detail, the injection kit is set on an injection device composed of a lid and a saucer, and the soft bag is slid forward by pressing the soft bag with a presser integrated with a push rod. When the easily peelable septum of the bag is broken, the solution flows into the solid medicine chamber, the solid medicine dissolves in the closed soft bag, and when the injection is prepared on the spot, the cap over the metal injection needle By further sliding the compression element forward, the gas layer remaining in the soft bag is pushed out from the injection needle, the preparation for injection is completed, and the compression element is further slid forward to compress the soft bag, The present invention relates to an injection device that can be directly injected into a patient in a method of extruding an injection.

[0008] In other words, the present invention provides a method for preparing an injection solution by dissolving a solid drug, and injecting the injection solution quickly and simply when intravenously, intramuscularly, subcutaneously, or intradermally. Safe and aseptic, without any mistakes in the combination of solid drug and dissolution solution and the amount of each, and the surgeon may be injured by glass fragments or injection needles derived from ampoules or glass vials. It is not necessary to select a place where the injection solution is prepared, including in the field, and it is possible to prepare an equivalent and homogeneous injection solution irrespective of the skill level of the surgeon's professional skills. Made injection solution made of glass,
Also, the present invention relates to an injection kit and an injection device which can be immediately administered to a patient without being transferred to a plastic syringe.

[0009]

2. Description of the Related Art Conventionally, ampules or vials made of glass or hard plastic have been known as containers for injections. In particular, drugs that are unstable in solution, or that degrade or absorb poorly when absorbed, are usually lyophilized in glass vials, while the solution is sealed in glass ampules. Is normal. Therefore, when performing an injection, cut the glass ampule, place a disposable metal injection needle in a disposable syringe, suck a certain amount of the dissolving solution into this, and remove the rubber stopper of the glass vial with the protective seal removed. After wiping with a cotton swab, puncture it with a syringe needle to inject the dissolving solution, remove the syringe needle once, the drug in the vial is completely dissolved, then pierce the rubber stopper again and suck it into the syringe barrel. The injection is ready.

As a container for an injection, a flexible container made of a soft plastic, that is, a so-called soft bag is known. Compared with glass containers, soft bags have the advantages of no risk of breakage, light weight, easy disposal after use, etc., and are suitable for storing large quantities of injections. Widely used as a container.

In particular, recently, a soft bag in which a plurality of compartments are formed by means of an easily peelable intermediate seal has been devised, and each compartment is filled with two or more liquid drugs which may be deteriorated if mixed. Then, just before injection, one of the liquid chambers was pressed by hand to break the septum and mix the drug solution. Thus, for example, it is used extremely conveniently when a solution containing an electrolyte and glucose and an amino acid solution are mixed and administered as an infusion.

When a soft bag is used as an infusion container, a port portion serving as an infusion outlet is provided in the soft bag, a rubber stopper is tightly sealed, and a syringe needle connected to a tube is pierced into the rubber stopper during use. It is usual to puncture a patient's vein with a syringe needle attached to the other end of the tube to inject a drip.

The soft bag in which a plurality of compartments are formed by the easily peelable intermediate seal portion can be used not only for drip injection but also for preparing an injection solution if it is miniaturized. That is, different liquid medicines are stored in a plurality of compartments, respectively, pressure is applied to the bag immediately before injection to peel off the intermediate seal portion, and a plurality of medicines can be mixed to prepare an injection solution. One of the chambers is filled with a solid drug, especially a solid drug that needs to be kept dry until immediately before injection, for example, antibiotics, anticancer drugs, etc., and the other is filled with its solution, and pressure is applied just before injection. Then, the intermediate seal portion is peeled off, and the solid drug is dissolved by the dissolving liquid flowing into the compartment filled with the solid drug to prepare an injection solution.

However, in these cases, in order to inject the prepared injection solution into the patient, the same applies to the case where the soft bag is one room and the liquid medicine is filled.
A metal syringe needle connected to a tube as described above is stabbed into a rubber stopper sealing the port of the container, and a syringe needle attached to the other end of the tube is stabbed into a patient's vein to perform injection. . Many such kits have already been put into practical use (for example, JP-A-2-4671 and JP-A-6-4671).
No. 14975).

This is different from the operation of injecting and dissolving a dissolving solution into a vial using a syringe and sucking and injecting the prepared injection as in the case of a solid drug contained in a vial. The advantages are that it is extremely simple and that injection solutions can be easily prepared even at the bedside, eliminating the risk of mixing solid agents and dissolving solutions and the amount of each used, and reducing the risk of contamination. is there. However, there is no danger of contamination, and the liquid volume is 1m.
It is difficult to reduce the volume such as 1, 2, 5, 10 or 20 ml, so that it is limited to the use of infusion.

A simple injection tool "UNIJECT" (Becton Dickinson and Company) in which a port is attached to a plastic drug solution reservoir and an injection needle is attached to the port.
Is known. In this method, the injection solution in the reservoir can be directly injected by crushing the reservoir with a finger, but the volume of the injection solution of the existing product of "UNIJECT" is as extremely small as 0.1 to 1 ml. It is used for special applications such as hepatitis B vaccine injection and tetanus vaccination, but it is difficult to apply when the volume of injection is usually used, that is, about 2 to 20 ml. It is not possible to provide a plurality of compartments in the or to prepare an injection solution by dissolving the solid drug in the container,
It has been used to inject small amounts of stable drugs in solution.

There have been reported a number of mechanisms for prefilling a solid drug and a solution in a syringe made of glass or hard plastic and dissolving in the syringe to prepare an injection solution on the spot at the time of use. (For example, see JP-A-62-148).
No. 63, Japanese Utility Model Laid-Open No. 2-58446, Japanese Utility Model Laid-Open No. 5-
No. 152).

More specifically, each of these devices partitions the inside of the syringe with gaskets of various shapes and the like, and puts a solid drug in one compartment and a solution in the other compartment, and pushes the piston of the syringe in use. Then, the lysis solution flows into the solid drug chamber through the bypass and dissolves it, and the injection solution is prepared on the spot, so that it can be injected as it is, but in any case, the mechanism is complicated, In addition, since it is difficult to stably maintain a dry drug that is unstable with respect to humidity in a dry state, none of them has been put to practical use.

Further, in the prior art, a glass vial containing a solid drug, a glass ampule containing a dissolved solution, a sterilized syringe, a sterilized injection needle, etc. are required until the solid drug is dissolved to prepare an injection solution. There are many points of equipment
Unless all of them are prepared, there is a problem that an injection cannot be prepared and injection cannot be continued.

Further, since the operation of preparing an injection solution is complicated, a syringe or other injection device during the operation is easily contaminated with the injection solution, and there is a risk of hospital infection even in a hospital. Even in the field, blocking infections
There was a problem that was almost impossible.

In preparing an injection according to the prior art,
There is also a problem that an accident frequently occurs in which an operator is injured by glass fragments derived from ampoules or vials or punctured by a metal injection needle.

In the prior art, when preparing an injection solution, the injection solution prepared by dissolving a solid drug with a dissolving solution was sucked and stored in the syringe in order to temporarily suck the injection solution into the syringe. There is a problem that the name of the injection solution cannot be correctly identified, and a medical accident is likely to occur frequently due to a wrong type or amount of the solid drug or the solution.

In the prior art, used disposable syringes and disposable injection needles are not impossible to use repeatedly, and therefore, many infections such as AIDS and hepatitis due to reuse of used contaminated tools have been reported.

In the prior art, when disposing of used disposable syringes and disposable injection needles, glass vials and glass ampules as medical waste, glass, plastic,
There was a problem that it had to be separated into various types, such as rubber and metal (needle).

As can be understood from the above, in the prior art, a solid drug is maintained in a dry state, and at the same time, it is easily and immediately dissolved in a dissolving solution to prepare an injection solution in a closed system. The contradictory requirement that the injection needle be ready with the already installed metal needle could not be met.

As a medicine container, a plastic flexible container (soft bag) is less likely to be damaged, lighter in weight, and easier to dispose of after use than a glass or hard plastic container. Despite the advantages of the above, there is no mechanism to push out the injection solution at a constant speed unlike a glass or plastic syringe, and drip injection is performed when the volume of the solution is large, Is 1
Conventionally, in the case of a small amount such as about 20 ml, it has to be transferred to a glass or hard plastic syringe and injected.

[0027]

Under such background of the prior art, the present invention provides a method for preparing an injection solution by using a very simple mechanism and operation to minimize the chance of infection even in a non-clean environment. It is possible to carry out injection directly to a patient through an injection needle installed in a soft bag, and to minimize the number of materials required for injection preparation, thereby making it possible to carry out drug injection. Injection kits that allow easy management and can limit used medical waste to only two types, plastic and metal (syringe needles), and inject using such injection kits It is an object to provide an injection device which can sometimes be used particularly advantageously.

[0028]

Means for Solving the Problems The inventor of the present invention has made intensive studies to achieve the object described in the preceding paragraph, and has completed the present invention on the assumption that the object is to be achieved.

That is, according to the present invention, a plastic flexible container (soft bag) having a multilayer film formed into a cylindrical shape is divided into two to four compartments by one or a plurality of partitions which are easily peelable and welded. The first chamber is provided with a nozzle-shaped injection liquid outlet and is filled with a solid drug, and the last tail chamber (the compartment farthest from the first chamber) dissolves the solid drug. And, if appropriate, the remaining one or two intermediate chambers are filled with a suitable different solid drug and / or lysate, and are provided in the first chamber. The injection outlet in the form of a nozzle is fitted with a metal injection needle, which is covered with a plastic protective cap before use, and the soft bag is connected to the injection outlet (tip). The outer edge on the opposite side (rear end) 4. A plurality of small holes capable of retaining the soft hug set in the injection device by being fitted to a plurality of columnar projections existing at a rear portion of the receiving plate of the injection device according to item 4. And an excellent method for producing such an injection kit.

The present invention also relates to a transparent and hard plastic box-shaped container capable of storing the soft bag of the above-mentioned injection kit, wherein a main body comprising a lid and a tray and a push rod are integrated in the rear. The main body consisting of a pressurizer equipped with a lid and a tray has a mechanism to fix them so that they do not come off by pressure from inside when closed, and a nozzle-shaped injection liquid of a soft bag is provided at the front end of the main body There is a hole or a cylindrical opening that allows the outlet part to protrude, and a hole or a cylindrical opening that allows the push rod of the compression unit to pass through the rear end of the main body. Slits that serve as guide rails on both sides of the lid are provided with projections that can fix the soft bag by being fitted into holes formed in the outer edge of the bag opposite to the injection solution outlet. The cylindrical projections provided on both sides of the shaft of the presser are fitted into the slits, and the presser is pushed out and the rod is pushed to push the soft bag containing the injection solution set in the main body in the forward direction. It has a shape and size suitable to be slidable, and the lid and the receiving tray are structured to open up and down around the short axis direction of the main body (longitudinal opening) or left and right around the long axis direction. The present invention relates to a device for injection characterized in that it has a structure that opens to the side (horizontal opening).

[0031]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, the present invention will be described in detail.

First, the injection kit according to the present invention will be described.

In the injection kit of the present invention, a flexible plastic bag (soft bag) of a multilayer film formed into a cylindrical shape is divided into a plurality of chambers by a partition made of easily peelable welding. The drug chamber) contains a solid drug, has a nozzle-shaped injection liquid outlet, a metal injection needle is mounted on the nozzle, and the metal injection needle is covered with a cap,
On the other hand, the last chamber furthest from the first chamber contains a solution for dissolving the solid drug.

When two types of solid drugs are used as the active ingredient of the injection solution, for example, if one of the two types of solid drugs is susceptible to oxidation and the other is oxidizing, the two types of solid drugs are used. Is preferably separated until use,
For that purpose, there are two solid medicine chambers. In addition, when a plurality of types of dissolution liquids, which are preferably separated until use, are used in combination, such as when a sugar liquid and an amino acid are used in combination as the dissolution liquid, the dissolution liquid chamber is made into a plurality of chambers. In addition, the arrangement order of the solid drug chamber and the solution chamber is such that the first chamber is a solid drug chamber, the last chamber is a solution chamber, and if an intermediate chamber is required, the solid drug chamber is located on the first chamber side. It is desirable that the solution chamber be brought to the tail chamber side.

The injection needle is held in the solid medicine chamber (first
The cap is fitted and welded to the nozzle-shaped injection liquid outlet of the chamber, and the cap is put on the injection needle and brought into close contact therewith.

In order to prevent the solid drug from absorbing moisture and being deteriorated, the solid drug chamber can be covered with a sheath-shaped bag for the purpose of moisture proof together with the capped metal injection needle. The material, use of the desiccant, and the like are as described above.

The sheath-shaped bag is peeled and removed before setting the injection kit of the present invention in the injection device of the present invention.

The length of the soft bag when the drug is filled,
The width and thickness vary depending on the amount of the filled solid drug and the amount of the solution, but when the amount of the solid drug is, for example, 1 to 2 g and the amount of the solution is, for example, 1, 2, 5, 10, or 20 ml, the width is about 1. 0.0 to 2.5 cm and a length of about 8 to 15 cm, and the thickness when the solution is filled is about 2 cm or less.

[0039] Such an injection kit can be produced very advantageously by the following production method.

That is, a plurality of compartments are formed by easy peeling welding, one end of a cylindrical flexible multilayer plastic bag sealed at both ends is cut off, and 1 ml,
Fill, seal with 5 ml, 5 ml, 10 ml or 20 ml of lysis solution. The soft bag filled with the solution is autoclaved at, for example, 105 to 130 ° C. for 30 to 60 minutes, then transferred to a sterile room, the other end of the solid drug room is cut off, and the product is manufactured by freeze-drying or the like from the open end. For example, 0.5, 1.0, 2.0 or 3.
It can be manufactured by filling 0 g, or a granule, or a tablet, and welding an injection liquid outlet nozzle previously provided with a capped injection needle to the opening.

As another method, the width of the soft bag subjected to easily peelable welding is manufactured to be about 6 to 20 mm wider than the width of the finished product, and a syringe needle with a cap is previously attached to one end thereof. Weld the nozzle of the attached injection solution outlet,
The other end is welded except that a small hole necessary for setting in the injection device is made. A side edge of the solution chamber of the unfilled wide bag is cut open at a width of about 1 to 2 mm, the solution is filled from the opening with one side of the soft bag facing upward, and after filling, it is sealed by welding. And cut to leave the side edges of the desired width.

After autoclaving, transfer to a sterile room,
The other side edge of the solid medicine chamber is incised with a width of about 1 to 2 mm, the solid medicine is filled from the opening wide open upward, and then sealed and sealed. Can be produced by cutting.

The kit for injection produced by these methods is covered with a sheath bag for the purpose of moisture proof covering the solid drug chamber and the injection needle, and the lower edge of the sheath is made of a soft bag which is easily peeled and welded. , Weld or glue.

Also, without forming a sheath-shaped bag in advance, a multilayer film of a gas-barrier transparent plastic film and a low-melting-point plastic film, or between a gas-barrier transparent plastic film and a low-melting-point plastic film. The solid medicine chamber of the injection kit and the injection needle portion are sandwiched by a multilayer film in which a desiccant is applied or adhered, or a desiccant powder is enclosed, or a paper containing a desiccant is inserted. , Four circumferences may be welded or bonded. Alternatively, a plurality of injection kits are simultaneously sandwiched by the above-mentioned multilayer films, and the solid medicine chamber of each injection kit and the four peripheral portions of the injection needle portion are welded or adhered, and a perforation is inserted between each injection kit. By doing so, a product in which a plurality of injection kits each having a moisture-proof bag are connected is produced. Such products are convenient to handle.

The injection kit packaged for the purpose of preventing moisture can be further externally packaged with a gas-barrier transparent plastic film.

Next, the injection device of the present invention will be described.

The injection device of the present invention is a device that can be used to prepare an injection solution by setting the injection kit according to the present invention and perform injection as it is.

This device comprises a main body composed of a lid and a tray, which can accommodate a flexible plastic container (soft bag) containing an injection with a nozzle-shaped injection liquid outlet, and a presser. . In the body consisting of the lid and the receiving plate,
A mechanism is provided to fix the lid so that it does not come off when the lid is closed (and the presser is pressed for injection) when the lid is closed. When closed, the front end of the main body has a hole or a cylindrical opening through which a nozzle-shaped injection liquid outlet portion of the soft bag can project, and the rear end of the main body can pass an extruding rod of a presser. There is a hole or a cylindrical opening, has a projection on the rear part of the saucer that can fix the soft bag, and the presser is integrally provided with an extruding rod at the rear, and by pressing the extruding rod, the main body is pressed. It has a shape and a size suitable for being able to slide forward while compressing the stored soft bag containing an injection.

The body of the injection device of the present invention comprising a lid and a saucer, and the material of the presser provided with the push rod may be sanitary, light and strong, and there are no special restrictions. However, metals such as stainless steel, aluminum and duralumin, or hard plastics such as polystyrene, polyvinyl chloride, polypropylene, ABS resin, methyl methacrylate resin, nylon resin, polyacetal and polycarbonate are preferred. Among them, a transparent hard plastic is most suitable for the main body, especially for the lid.
The compression element and push rod can be colored, for example, blue, red, brown, etc., for easy identification.

The size and shape of the main body are determined by the size (filled volume) and shape of the soft bag to be stored.
The size is usually about 5 to 50 ml, and the shape is preferably a rectangle or a trapezoid whose cross section is longer than the height, and is box-shaped when covered.

The relation between the lid of the main body and the tray may be such that the lid may be put on the tray, but the shape and size of the edge of the lid and the edge of the tray may be exactly the same, and the two may be abutted. . In this case, a rim may be provided wholly or partially on the outside of either the lid or the tray to ensure abutment. Needless to say, for smooth sliding of the presser, it is preferable that the inner surface of the main body has no unevenness.

Further, as mentioned above, a mechanism is provided to fix the lid and the tray when the lid is closed so that the lid and the tray do not come off and open due to the pressure from inside when the presser is slid. It is necessary to be. Although this mechanism may be a method of fastening with a clasp, etc., it is also possible to achieve the purpose by making protrusions and notches that mesh with each other on the edges of both the lid and the tray or on the rim provided outside thereof, and meshing them. It is possible.

In the case of a structure in which the lid of the injection device is placed vertically on the axis of the short axis of the injection device covered on the receiving plate (referred to as "vertical opening"), a projection is formed at the lower front end surface of the lid. The lid and the receiving plate can be fixed so as not to be opened by engaging with the projection provided on the lower part of the front end surface of the receiving plate (FIG. 3).

In this case, small holes are provided on the rims on both sides of the rear end of the lid so that the lid can be opened vertically, and small cylindrical projections are provided on the rims on both sides of the rear end of the receiving plate so as to correspond to the small holes. Provided,
By fitting both the small hole and the columnar projection on both sides, it can be used as a fulcrum of the vertically opening rotation.

Of course, it is also possible to adopt a structure in which the lid of the injection device is placed on the receiving plate and opened to the left and right about the longitudinal direction of the main body of the injection device. A hinge is provided on either the left or right, and a clasp is provided on the opposite mating part. Thereby, the lid and the receiving dish are fixed.

For proper operation, the press has small projections on both sides and slits on both sides of the lid so that it can fit with the small projections. The presser fits this into the slit, and slides back and forth with the push rod using the slit as a guide rail.

The height of the slits provided on both sides of the lid from the bottom of the receiving plate is determined by the distance between the lower edge of the pressing device and the receiving plate when the small projection of the pressing device is fitted to the slit. Make it the thickness of the soft bag after being extruded. The length of the slit may be a length from a position where the front edge of the compression element stops inside the rear outer edge of the soft bag when the soft bag is set in the injection device, to a position where the injection solution is completely pushed out.

A scale for confirming the position of the compression unit can be provided on the upper surface or the side surface of the injection device.

The injection using the injection kit and the injection device of the present invention can be performed, for example, as follows.

That is, a small hole at the outer edge of the rear end of the soft bag from which the sheath-shaped moisture-proof bag was peeled off was attached to the rear end of the injection-instrument receiving tray portion of the injection device with the push rod pulled back most backward. And set it by fitting it to the small projection provided on
Close the lid. When the compress is slightly slid forward, the dissolving liquid portion is compressed, the partition wall of the easily peelable weld is broken, and the dissolving solution flows into the solid medicine chamber to dissolve the solid medicine and form an injection liquid.

After confirming that the solid drug was completely dissolved, the protective cap of the injection needle was removed, and the compression needle was further slid with the tip of the metal needle facing upward to completely remove the air layer remaining in the soft bag. Extrude is ready for injection.

After puncturing the patient's skin cleaned with alcoholic cotton or the like and completing the injection intravenously, intramuscularly, subcutaneously, or intradermally, the needle is removed, and the lid of the injection device is removed. Is opened, and the push rod is returned to the rear to take out the used soft bag and take out the medical waste, but it is desirable that the plastic part and the metal needle are cut and separated.

The injection device of the present invention can be used repeatedly, and sterilization washing is not required every time except in special circumstances.

The above description has been made mainly on the assumption that the soft bag of the injection kit to be set in the injection device of the present invention has two chambers. It can be easily understood that the invention can be applied mutatis mutandis to the case where the number of compartments by the partition in the soft bag of the injection kit of the present invention is not two but three or four. In addition, the same injection kit can be used by setting it in the injection kit of the present invention except for one chamber containing the drug solution. In this case, when the push rod is pushed forward, the injection liquid is injected from the metal injection needle. It can be extruded to perform an injection.

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

FIG. 1 shows a conceptual diagram of an example of the injection kit of the present invention. (A) is a front view, and (b) is a side view.

The container shown in FIG. 1 is a flexible plastic container (soft bag) made of a multilayer film and formed into a cylindrical shape. A nozzle 2 is welded to the first chamber as an injection liquid outlet, and a metal injection needle 3 is attached to the nozzle 2 in the first chamber. The injection needle 3 is covered with a protective cap 4.

For forming a soft bag, a sheet molding method, a blow molding method, or any other method may be used.

The injection liquid outlet to be welded to the first chamber a is manufactured by welding a metal injection needle 3 covered with a cap 4 to the nozzle 2 in advance and welding it to the front end of the first chamber a. Is also good.

The multilayer film 5 constituting the cylindrical bag of the injection kit
Is made of PE such as HDPE, LDPE, LLDPE, or any two or three kinds of materials such as PP and PVA. It is necessary to combine such that the melting point of the plastic forming the innermost layer is lower than the melting point of the plastic forming the outer layer film. It is known that only the innermost layers are welded to form easily peelable welds. The plastic film used in the present invention needs to be heat-sterilized for the dissolving solution. Therefore, it is desirable that the plastic film be able to withstand heating at, for example, 105 to 130 ° C. which is suitable for the solution.

The solid drug A contained in the first chamber a of the kit for injection includes antibiotics, anticancer drugs, cytokines, various bioactive factors, peptides, proteins, and various ribosomes. In addition, a substance which is stable in a dry state and hardly causes chemical change or denaturation, and which is mixed with a hydratable substance such as low molecular weight dextrin, PEG, HES, human albumin as a bulking agent or a stabilizer. Also, freeze-drying, reduced-pressure drying, solubilization such as spray drying, powders that have been subjected to treatment such as fine powder, granules, tablets and the like, the amount of which is not particularly limited, For example, it can be about 0.05 to 3 g.

The solution B contained in the second chamber b of the injection kit may be a mixture of one or more of salts, sugars, vitamins, amino acids, proteins, peptides, etc., in addition to distilled water. For example, 0.5 to 20 ml of an aqueous solution or a fat emulsion can be accommodated in the second chamber b.

When it is desired to dissolve a solid drug in a combination of liquid agents which is destabilized by mixing, for example, a mixed solution consisting of a solution of an amino acid and a saccharide, a combination of a fat emulsion and an amino acid solution, the second partition is formed. The third chamber formed may be used as a second solution chamber to be filled with the second solution.

At the rear of the outer edge of the soft bag, a plurality of small holes 2 are provided.
2 are drilled and the holes are
It is used to hold the soft bag by fitting into the small projection 21 installed inside the rear part of the soft bag.

FIG. 2 shows the first chamber (solid medicine chamber) of the soft bag equipped with the injection needle 3 with the cap 4 of the injection kit.
FIG. 5 is a conceptual diagram in which a portion a is covered with a sheath-shaped moisture-proof bag 6 and easily peelable welding or easily peelable pressure bonding is applied to a portion of a partition 1 where soft peeling of a soft bag is performed. . (A) is a front view, and (b) is a side view.

In order to keep the solid medicine A in a dry state, the sheath-shaped bag 6 is formed by laminating a gas-permeable soft low-melting plastic film on a gas-permeable transparent plastic film.
The bag is made with the layer film 23. A desiccant 25 is applied, adhered, or printed on a part of the inner surface of the bag, or a desiccant 25 is sandwiched between a gas barrier plastic film and a gas permeable soft low melting point plastic film 24. You may make a bag. However, be prepared to observe the internal state.
Alternatively, the same purpose can be achieved by arranging the desiccant in a suitable form such as a bag in the space between the injection kit and the two-layer membrane covering the same.

FIG. 3 shows a conceptual diagram of an example of the injection device of the present invention. (A) is a front view, and (b) is a side view.

In this example, the main body is formed by injection molding of polystyrene, which is a kind of hard plastic, in which the lid 7 and the receiving tray 8 are separately molded, and the lid 7 is sized to cover the receiving tray 8.

A rim 9 is provided at the lower part on both sides of the rear end of the lid.
0 is drilled. A rim 11 having a size corresponding to the rim 9 of the lid is provided at a lower portion on both sides of the rear end of the receiving plate 8, and small cylindrical projections 12 (not shown) are provided at positions corresponding to the small holes 10 formed in the rim of the lid. In addition, by fitting the small projection 12 into the small hole 10 on the lid side, the lid is opened vertically with the small projection 12 as an axis.

On the front surface of the lid 7, there is a vertical cut 13 having a width corresponding to the outer diameter of the nozzle portion 2 of the soft bag, and the upper part is semi-cylindrical. There is also a similar semi-cylindrical cut 13 on the receiving plate 8 side, and when the soft bag of the injection kit is set in the injection device, the nozzle 2 of the soft bag is sandwiched from above and below, and the role of retaining the injection needle. To fulfill.

A ridge 14 is provided on the lower edge of the front surface of the lid, and engages with the ridge 15 on the receiving tray side to close and fix the lid and the receiving tray.

On the rear surface of the lid 7, the push rod 1
There is a circular hole 18 through which 7 passes.

The rear surface of the receiving tray 8 may not be provided.

When the cover 7 covers the receiving tray 8, the shape of the main body may be rectangular, circular, oval or the like. Lid 7
Can be, for example, 0.5 to 2.5 cm, and the depth of the receiving dish 8 can be, for example, 0.5 to 1.5 cm.

On both sides of the lid 7, there are slits 19 along the long axis of the injection device, and small projections 20 provided on the shafts on both sides of the compression element 16 are fitted into the slits 19, and the compression element 16 is Guide rail for sliding forward.

The distance between the slit 19 and the bottom surface of the tray is determined by the size of the small projection 2 when the presser 16 crushes the soft bag.
The position may be 0.

The length of the slit 19 ranges from the position of the trailing edge of the soft bag when the soft bag is set in the injection device to the position of the soft bag injection solution outlet when the injection solution is completely discharged. Small protrusion 20 on the axis of the presser 16
In the section where there is, the slit width is
It is equivalent to the thickness of

Two or three columnar projections 21 are provided on the inner bottom surface of the rear portion of the receiving tray 8. When the soft bag of the injection kit is set in the injection device, two or three small holes 22 provided at the rear portion of the outer edge of the soft bag are fitted into the projections, whereby the compression element 16 slides forward. At the time, a soft bag is retained.

The thickness of the compress 16 is determined by the distance between the bottom surface of the receiving plate of the main body of the injection device and the ceiling of the lid when the soft bag is set in the injection device and the lid is closed. The thickness may be subtracted. It is preferable that the shape of the presser 16 viewed from the front conforms to the shape of the cross section of the lumen of the injection device, and the lower surface for pressing the soft bag needs to be smooth.

The color of the compression element 16 and the push rod 17 is preferably colored such as blue, brown, yellow or green so that the position of the tip of the compression element becomes clear.

A scale is provided on the upper surface of the injection device,
It is also preferable to make the progress of the presser 16 visible. If the name, amount, concentration, and other necessary items of the drug are printed on the surface of the soft bag, it can be confirmed directly through a transparent plastic injection device.

FIG. 4 shows a conceptual diagram of another example of the injection device.

In this example, the lid 7 of the injection device and the receiving plate 8 are in contact with each other, and the lid 7 is opened sideways along the long axis direction. Thus, for example, a hinge 23 is provided on either the left or right side of the mating, and a clasp 24 is provided on the opposing mating portion to determine if it was on the lower edge of the front of the lid and saucer in the example above. Ridge 1 for mating
No rims 4 and 15 and the rim 9 made at the lower part of the lid and the back end of the receiving dish are unnecessary, but the other parts are the same as in the above-mentioned example. However, the slit 19 is biased upward on both sides of the lid side 7. Therefore, the small projection 20 on the axis of the presser 16 is also installed to be biased above the presser.

FIGS. 5 and 6 are conceptual views showing a state in which the injection kit of the present invention is set in the vertically opening and horizontally opening injection device of the present invention, respectively.

[0095]

The preparation of the injection solution should be given particular attention to cleanliness, but the use of the injection kit and the injection device according to the present invention makes it possible to use the injection kit anytime, anywhere, anytime, anywhere. Even if anyone works, a sterile injection can be prepared safely, easily and quickly, and the prepared injection can be removed immediately by removing the protective cap over the injection needle. The ability to perform injections can significantly reduce the patient's risk of infection.

The plastic flexible container (soft bag) having a multilayer film is divided into a plurality of compartments by an easily peelable partition, and when used, the dissolving solution chamber is pressed to dissolve the solid drug with the dissolving solution. Although making injection solutions has already been put to practical use, according to the injection kit and injection device of the present invention, 1 to 20 ml is used.
Injectable solutions of the order of the volume can also be prepared easily and can be directly injected into patients from soft bags.

The injection device of the present invention can be used not only for an injection kit having a plurality of compartments but also for a single-chamber injection kit filled with a single solution.

According to the present invention, during the preparation of the injection solution, the operator is not injured by a glass piece derived from a vial or an ampule, and the puncture caused by the injection needle can be drastically reduced.

The name of the drug, the name of the solution, the amount and concentration thereof, etc. can be printed on the surface of the soft bag of the injection kit of the present invention. Can be visually recognized even during the injection, so that it is easy to identify the solid drug and the solution, thereby minimizing a medical accident due to mistakenly taking these.

The injection kit and injection device of the present invention
Since it is composed of only plastic and metal (injection needle), after use, medical waste is separated into only two types, and the separation and disposal is extremely simple.

The injection device according to the present invention can be used repeatedly except in special cases, and need not be discarded each time. Sterilization is not always necessary for each use, and the practitioner can always carry it.

The injection kit according to the present invention can be used in a pharmacy because the necessary equipment for preparing an injection solution is completely integrated and complete for each drug, and the injection device can be used repeatedly. And equipment management can be significantly streamlined.

[Brief description of the drawings]

FIG. 1 shows a conceptual diagram of an example of an injection kit of the present invention.
(A) is a front view, and (b) is a side view.

FIG. 2 shows a conceptual diagram when the injection kit of the present invention is covered and sealed with a gas barrier moisture-proof bag of the present invention.
(A) is a front view, and (b) is a side view.

FIG. 3 shows a conceptual diagram of an example (vertical opening) of the injection device of the present invention. (A) is a front view, and (b) is a side view.

FIG. 4 shows a conceptual diagram of another example (horizontal opening) of the injection device of the present invention. (A) is a front view, and (b) is a side view.

FIG. 5 is a conceptual diagram showing a state in which the injection kit of the present invention is set on the injection device (vertical opening) of the present invention. (A) is a front view, (b) is a side view, and (c) is a front view.

FIG. 6 is a conceptual diagram showing a state in which the injection kit of the present invention is set on the injection device (horizontal opening) of the present invention. (A) is a front view, and (b) is a side view.

[Explanation of symbols]

Reference Signs List A solid drug B solution a solid drug chamber b solution chamber 1 easily peelable partition wall 2 nozzle 3 metal injection needle 4 protective cap same as above 5 multilayer film 6 moisture barrier / oxidation prevention composed of gas barrier film Bag 7 lid 8 receiving tray 9 rim of lid 7 10 small hole of rim 9 of lid 7 (small projection 1 of receiving tray 8 rim 9)
11) Rim of the receiving tray 8 12 Small protrusion of the rim of the receiving tray 8 (fit into the cover hole 10) 13 Notch on the front of the lid and receiving tray (opening of the nozzle 2) 14 Lower front of the lid Ridge inside the rim (for engagement) 15 Ridge outside the bottom edge of the receiving tray (for engagement) 16 Compressor for injection device 17 Push rod for injection device 18 Hole for pushing rod 17 19 Slit 20 Small for compression device 16 Projection (fits into slit 19) 21 Small projection inside soft dish (soft bag small hole 22)
22 Soft bag small hole 23 Gas barrier film 24 Gas permeable low melting point plastic film 25 Desiccant

Claims (4)

[Claims] 1. A plastic flexible container (soft bag) having a multilayer film formed into a cylindrical shape and divided into two to four compartments by one or more partitions which are easily peelable. One chamber is provided with a nozzle-shaped injection liquid outlet and is filled with a solid drug, and a solution for dissolving the solid drug is disposed in the tail chamber (the compartment farthest from the first chamber). Filled and, if applicable, the remaining one or two intermediate chambers are filled with a suitable different solid drug and / or solution, and a nozzle-shaped nozzle provided in the first chamber. The injection solution outlet is equipped with a metal injection needle, which is covered with a plastic protective cap before use, and the soft bag is opposite to the injection solution outlet (tip) (the tip). The outer edge of the rear end) is
A plurality of small holes capable of retaining the soft hug set in the injection device by being fitted to a plurality of columnar projections present at the back portion of the receiving dish of the injection device described in the above. A kit for injection characterized by the following. 2. A multilayer film comprising a gas-barrier transparent plastic film and a soft low-melting plastic film, or a desiccant applied or adhered between two such multilayer films, or a desiccant. The entire solid medicine chamber, which is equipped with a metal injection needle with a cap, is covered with a sheath-shaped bag of a multilayer film in which powder is enclosed or a paper containing a desiccant is inserted, and a sheath is formed. The lower edge of the bag is welded or adhered at the easily peelable welded part of the soft bag to maintain airtightness, or a sheath of a multilayer film consisting of a gas-barrier transparent plastic film and a soft low-melting plastic film. The entire solid drug chamber, which is equipped with a metal injection needle with a cap, is covered with a bag,
In addition, the lower edge of the sheath bag is welded or adhered at the easily peelable welding portion of the soft bag to maintain airtightness, and a desiccant is disposed in a space between the sheath bag and the solid drug chamber. And when
2. The sheath bag can be removed when setting the soft bag in the injection device.
The kit for injection according to the above. A solid injection needle, which is not filled with a solid drug nor a solution, is welded to one end with a metal injection needle covered with a cap via a nozzle. 4. The injection bag according to claim 4, wherein the injection bag is made of a plastic flexible empty bag of a wide multilayer film having a small hole to be fitted to a cylindrical projection existing in a receiving plate of the injection device. Dissolve the side edge of the dissolution solution chamber, inject the dissolution solution, weld and seal the incision so that it has a predetermined width, cut it into a predetermined width, sterilize it, and sterilize it. The outer edge is similarly cut and filled with a solid drug, the cut is welded to a predetermined width, sealed, and cut into a predetermined width.
Or the method for producing the injection kit according to 2 above. 4. A transparent and hard plastic box-shaped container capable of accommodating the soft bag of the injection kit according to claim 1, wherein a main body comprising a lid and a tray and a push rod are integrated in the rear. The main body consisting of a pressurizer equipped with a lid and a tray has a mechanism to fix them so that they do not come off by pressure from inside when closed, and a nozzle-shaped injection liquid of a soft bag is provided at the front end of the main body There is a hole or a cylindrical opening that allows the outlet part to protrude, and a hole or a cylindrical opening that allows the push rod of the compression unit to pass through the rear end of the main body. Slits that serve as guide rails on both sides of the lid have projections that can fix the soft bag by being fitted with holes that are opened at the outer edge of the bag opposite to the injection solution outlet. Setting The cylindrical protrusions provided on both sides of the shaft of the presser are fitted into the slits, and the presser is pushed out and the rod is pushed out, thereby sliding in the forward direction while pressing the soft bag containing the injection solution set in the main body. It has a shape and size suitable to be able to perform, and the lid and the receiving tray are a structure that opens up and down around the short axis direction of the main body (longitudinal opening) or opens right and left around the long axis direction An injection device having a structure (horizontal opening).