JPH09164203A - Syringe and its production - Google Patents

Abstract

PROBLEM TO BE SOLVED: To administer two kinds of medicines varying in drug action with one time of pricking to enhance the cost performance by press feeding the pressers corresponding to plural cylindrical bodies to allow the respective medicines to flow out through a hypodermic needle and forming these injection cylinders by one time of injection molding of synthetic resins. SOLUTION: The two flow passages at one front end 23 of the two injection cylinders 21, 22 of the syringe 20 molded by one time of injection molding of the synthetic resins as raw materials are hermetically sealed by a common cap 26. The open port of the other end is closed by pistons 28, 29 and rubber pugs 32, 33 are fitted behind the same. Further, the syringe is covered with a cap 34 from the outside of the cylinders 21, 22 and the rubber pugs 32, 33, by which the structure to withstand any environment change is obtd. At the time of using the medicinal liquids 24, 25 in the cylinders 21, 22, a connector 36 and the hypodermic needle 37 are mounted at the front end 23 and the front ends of the pressers 17 are engaged with the recessed of the pistons 28, 29 and are pushed into both cylinders, by which the medicinal liquids 24, 25 are allowed to flow through the hypodermic needle 37 and are administered to a patient.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention provides a hygienic and convenient administration method in which prescribed amounts of drugs are stored in different cylinders, and each drug can be simultaneously discharged with a single needle stick during administration. And a manufacturing method thereof.

[0002]

2. Description of the Related Art The ability to store two or more drugs in a syringe and to administer them simultaneously at the same time is expected to bring about pain relief, rapid exertion of drug efficacy, and synergistic effects. This is a very pleasing method for patients.

As a type of syringe for simultaneous administration of such drugs, a type in which one syringe barrel is divided by a sealing stopper or the like, for example, Jikken Sho 49-1446.
No. 95, Japanese Patent Laid-Open No. 51-11691, and Japanese Utility Model Publication No. 5-152.
No. 4, Tokuhei 4-33233, Tokuhei 4-60673
And Dohei 5-27426.

There is also a syringe in which two syringes are arranged in parallel in the axial direction of the cylinder and a plunger (presser) is used to inject and administer the in-cylinder drug solution all at once. For example, Japanese Patent Publication No. 62-502.
No. 876, Tokuhei 4-500622, Actual Kaihei 6-51
0442, Tokuhei 6-510441, Actual Kaihei 6-7
746 and JP-A-7-153375.

[0005]

However, any of the above-mentioned conventional products has a mechanism as a syringe which is too complicated, and is deficient at present due to the ease of administration, the manufacturing process of the syringe and the hygiene. There are many. INDUSTRIAL APPLICABILITY The syringe of the present invention is a syringe suitable for a single product for an unstable drug that is difficult to prepare in a complex formulation, and can be administered hygienically and conveniently for living organisms, and two or more drugs having different drug effects can be administered by one needle stick. Syringe is to improve the effect of the drug quickly, and to improve the therapeutic efficiency, and to increase the overall economy so as to be suitable for carrying and transportation. Also provided is an economical method of manufacturing the syringe.

[0006]

Means for Solving the Problems As a means for solving the above problems, the present invention comprises (1) a plurality of cylindrical bodies for containing and storing medicines, and the tip side of each cylindrical body is sealed until injection of an injectable drug. An injection cylinder sealed by a stopper and having a rear end side of each cylinder sealed with a piston slidable in the cylinder after being filled with the drug, (2) a mounting portion of the tip ends of the plurality of cylinders And (3) a plurality of pushers corresponding to the plurality of cylindrical bodies are arranged in parallel with each other and are bound together at the rear end to form a single pusher unit. ,
The plurality of cylindrical bodies having the same internal volume or different internal volumes are arranged in parallel in parallel to the cylinder axis direction, and a part of the outer peripheral portion is fixed by two or more binding means, or the entire outer peripheral portion is fixed. Are fixed in one outer peripheral layer, and at the time of administration, the tip opening portions of the plurality of cylinders are covered with the attachment portions of the injection needle portions so that the space inside the attachment portions and the inside of each cylinder communicate with each other. After that, a plurality of pressers corresponding to the plurality of cylinders are press-fitted to allow the drug in each cylinder to flow out to the internal space of the attachment portion through the opening on the distal end side, and subsequently, an injection that communicates with the internal space of the attachment portion. (EN) Provided is a syringe characterized in that it can flow out of a syringe through a needle tube of a needle, and the above-mentioned injection cylinder is formed by injection molding once using a synthetic resin as a raw material. As a particularly preferred embodiment of the present invention, there is a space between the plurality of cylindrical bodies, and the plurality of cylindrical bodies are formed in a shape having a plurality of holes penetrating in the axial direction of one rod-shaped material. That the different types of medicines are stored in each of the plurality of cylinders, and a soft tube communicates between the attachment portion and the injection needle, and the soft tube and the injection needle are connected. In the part, two blades are attached to the injection needle base with a bub, and the synthetic resin is a group consisting of a resin containing an olefin resin, a cyclic olefin compound or a crosslinked cyclic hydrocarbon compound as a polymer component. It can be aged that it is composed of one or more kinds selected. A thermoplastic norbornene-based resin is particularly preferable as the synthetic resin. Furthermore, the present invention provides a method for producing the above-mentioned syringe, wherein the injection cylinder is produced by injection molding in which molten synthetic resin is injected once into one mold. I will provide a.

[0007]

BEST MODE FOR CARRYING OUT THE INVENTION The container / syringe of the present invention (hereinafter abbreviated as "syringe") has a substantially cylindrical shape and is filled or housed with a drug (solid or liquid), and is attached to an injection needle mounting side (hereinafter referred to as a tip). Inner diameter smaller than the cylindrical body,
A cylindrical body (hereinafter abbreviated as "tube") that is a unit container in which the end protruding in a tubular shape with an outer diameter is sealed with a cap, and the other rear end side end is sealed with a sealing stopper made of an elastic body. Two or more,
It is a syringe which is basically molded by synthesizing once in a synthetic resin, based on a structure in which the syringes are arranged side by side in parallel with the cylinder axis direction. Drugs (medicinal solutions) having different medicinal effects can be put in the respective cylinders, and two or more kinds of medicinal solutions can be simultaneously administered with a single needle stick to the living body. As a result, the present invention provides a syringe capable of synergizing the effects of drugs and performing optimal treatment and reducing the pain of needle stick to the patient, and can be manufactured economically, and the sterilization process and the like are easy and easy. To provide a highly hygienic syringe capable of sufficient sterilization.

FIG. 1 is a schematic sectional view for explaining an embodiment of the present invention. (A) is a sectional view parallel to the cylinder axis direction of two cylinders, (b) is (a) AA '. A sectional view, (c) is a BB 'sectional view of (a). The syringe 1 has two cylinders, a cylinder 2 and a cylinder 3, which are bound together by two horizontal bars 4 and 5 which are parallel to each other and are orthogonal to the cylinder axis of the cylinder, and between the cylinder 2 and the cylinder 3. Space 6
Exists. The tips 7 and 8 of the tubes 2 and 3 project in a thin tubular shape and are hermetically sealed by caps 11 and 12, respectively.

Chemical liquids 9 and 10 having different chemical effects are contained in the cylinders 2 and 3, respectively, and the rear ends (opening ports) are sealed with pistons (sealing plugs) 13 and 14. The piston 13,
14 is an elastic body known in this technical field to ensure a high hermeticity and hermetically retains the chemicals 9 and 10 in the cylinder, and a plurality of ribs are provided on the outer peripheral portions of the pistons 13 and 14 in contact with the cylinder inner wall. By providing 15 to ensure slidability,
During administration, the drug solution can be easily and gradually discharged hygienically. Further, a groove 16 for engaging a pusher 17 for press-fitting the pistons 13, 14 into the cylinder is provided.

As shown in the schematic sectional view of FIG. 2, the pusher 17 has a structure in which two rods are connected at the end opposite to the side where the pistons engage with the pistons so that the pistons 13 and 14 can be simultaneously pressed. Is.

At the outer peripheries of the open mouths of the cylinders 2 and 3, a horizontal bar 4 connecting both cylinders forms a flange 18 which continuously surrounds the cylinder outer circumferences from the portion in contact with the cylinders 2 and 3, and is used for administration. Acts as a finger band, flange 18, horizontal bar 4, piston 1
The entire surface of 3, 14 is covered with a cap 19 in an airtight manner to protect from environmental conditions during transportation and storage, prevent contamination of fine particles, bacteria, etc., and assure hygiene of syringes and stored chemicals.

FIG. 2 is a schematic cross-sectional view for explaining another embodiment of the present invention. FIG. 2A is a view showing a cross section parallel to the cylinder axis direction of the injection cylinder, and FIG. ) Is C-of (a)
2 is a sectional view of the injection needle portion, and FIG.
(D) is a sectional view of the presser. The syringe 20 is a cylinder 21,
The two cylinders of the cylinder 22 are bundled in parallel with the cylinder axis. In the case of this embodiment, there is no space between the cylinder 21 and the cylinder 22, and the two cylinders are in contact with each other. Since it is in the position, the distal tubular protrusion of the cylinder 21 and the distal tubular protrusion of the cylinder 22 form one tubular protrusion 13 having two flow paths in a cross section orthogonal to the cylinder axis. The channel is hermetically sealed with a common cap (rubber stopper) 26. An annular projection 27 is provided on the outer circumference of the tip 23, and a rubber plug 26 having an annular recess is provided on the inner wall surface of the rubber plug which is in contact with the tip 23 so as to engage with the projection 27 to improve the sealing performance. Therefore, the cylinder 21,
Chemical liquids 24 and 2 having different medicinal effects stored in the cylinder 22
No. 5 does not mix and the quality can be retained even after long-term storage.

The open ends of the other ends of the cylindrical bodies 21, 22 are sealed by pistons 28, 29, and two or more ribs 15 are provided on the outer peripheral surface of the pistons 28, 29 in contact with the inner wall of the cylinder to provide slidability. And the groove 16 for engaging with the pusher 17 is provided. In this embodiment, rubber stoppers 32 and 33 are fitted behind pistons 28 and 29, and annular protrusions are provided on the inner wall of the distal end of the cylinder, and the rubber plugs 32 and 33 are provided on the outer peripheral surface in contact with the inner wall of the cylinder. A very high degree of airtightness is obtained by engaging the annular recess. In this example, the syringe barrel and the rubber stopper 3 are further used.
The caps 34 cover the outer surfaces of the parts 2, 33 so that they can withstand any environmental changes. As shown in FIG. 2B, protrusions 35 having a saw-tooth cross section are provided on the outer peripheral surfaces of the cylinders 21 and 22 to obtain the effect of finger hooking when administering the liquid medicine.

When using the chemical liquids 24 and 25 in the cylinders 21 and 22, a connecting body 36 and an injection needle 37 are attached to the tip 23 of the cylinder, and the tip of the pusher 17 is engaged with the recesses of the pistons 28 and 29. By pushing it into both cylinders,
5 flows out through the inside of the injection needle 37 and is administered.

FIG. 3 is a schematic cross-sectional view for explaining a syringe according to another embodiment of the present invention. (A) is a view showing a cross section parallel to the cylinder axis direction of the injection cylinder portion, and (B) is (A). 6 is a cross-sectional view taken along line D-D ′ of FIG. The syringe 38 has almost the same structure as the syringe barrel of FIG. 2, but the inner diameters of the two barrels 39 and 40 are different,
The entire injection cylinder has a sectional shape as shown in (b). 41 and 42 are the protruding tip tubular portions of each tube, 2
Reference numeral 7 denotes a ring-shaped projection on the outer circumference of the tip portion, and 43 denotes a rubber stopper having a ring-shaped recess in the inner wall. By engaging the recess 27 with the projection 27, the contents of the tips 41 and 42 are completely separated without being mixed. And then sealed. The chemical liquids 44 and 45 are stored in the cylinders 39 and 40, respectively.
Is larger than the chemical liquid 45 in the cylinder 40. As described above, the syringe of this embodiment is suitable for administering drugs having greatly different drug solutions.

The connecting tube 46 that engages with the protruding narrow opening at the tip of the tube 39, 40 has a soft tube 47 in the funnel-shaped cavity, and the injection needle 4 is attached to the tip of the soft tube.
8 is attached. The injection needle 48 has two wings 49 at the base of the needle, and a soft tube 47 and a needle 4 are attached at a hub 50.
8 is glued. Since the wing-shaped body 49 is made of a material capable of adhering to the skin, it is a syringe which is characterized by facilitating self-administration for a patient and allowing it to be pierced with almost no pain by making a needle thin.

FIG. 4 is a view for explaining still another embodiment of the present invention, showing a cross section in a direction orthogonal to the cylinder axis. This example has a form in which three cylindrical bodies are bundled, and a cylinder 51 and a cylinder 5 are provided.
2. Three kinds of medicines 54, 55, 56 can be stored in the cylinder 53. Each drug has a different medicinal effect, and since multiple types of simultaneous administration can be realized by one needle stick, there is no pain, faster medicinal effect,
A syringe that can exert synergistic effects such as improved efficacy and the like is extremely convenient for patients.

FIG. 5 is a schematic cross sectional view for explaining still another embodiment of the present invention, showing a cross section in a direction orthogonal to the cylinder axis. This example also has a configuration in which three cylindrical bodies are bundled, and the cylinder 5
7, 58 and the cylinder 59 store three kinds of medicines 60, 61 and 62, but since the insides of the cylinder 57 and the cylinder 58 have the same volume, the medicines 60 and 61 have the same capacity, The cylinder 59 has a small inner diameter, and the medicine 62 is a syringe containing a smaller amount than the medicines 60 and 61. Further, it is of course possible to change the inner volume of each cylinder so that the volume ratio is 1: 0.75: 0.5.

The need for the syringe of FIG. 5 will be explained as follows. It is essential that the drug for injection be soluble in water and blood. As a means for improving the solubility of a drug in water and blood, the first simple method is to change the hydrogen ion concentration, and the second is emulsification (emulsification). Any suitable method may be used. The present invention can be applied to either method because the volume of the injection cylinder (cylindrical body) can be changed. By obtaining the optimal solubility, the patient's pain during administration can be reduced. Although the present invention has been described above with reference to the example of 2 to 3 cylinders, in the present invention, a larger number of cylinders, for example, 4 cylinders are bundled, and 4 kinds of drugs having different drug efficacy in each cylinder. Needless to say, it can be a syringe preparation in which

As described above, the syringe of the present invention has a structure which is advantageous for both the user and the patient, but also has a great advantage in manufacturing. That is, in the conventional manufacturing of a syringe in which drug storage portions are arranged in parallel and a plurality of drugs are simultaneously administered, an injection cylinder is formed into one tube by using glass or synthetic resin as a material, Were either bundled by a binding means that was manufactured separately, or were assembled in a box that was manufactured separately. On the other hand, according to the present invention, by using a specific synthetic resin material, a plurality of cylindrical bodies can be manufactured by one-step injection molding using one mold.

The fact that the synthetic resin can be used as a material for an injection cylinder in the present invention is due to the development of a new synthetic resin. The synthetic resin used in the present invention is preferably an olefin resin. That is, one or more kinds of resins having a polymer component of polyethylene, polypropylene, a cyclic olefin compound or a crosslinked cyclic hydrocarbon compound can be used. In particular, thermoplastic norbornene-based resin has heat resistance (Tg of about 200c) and optical characteristics (light transmittance of 91%.
Above), gas barrier properties, chemical resistance (water resistance, steam resistance, acid resistance, alkali resistance, hydrochloric acid resistance, polar solvent resistance),
It is a synthetic resin with excellent properties of high safety and hygiene (Japanese Pharmacopoeia, Ministry of Health and Welfare No. 20, etc.),
It is a desirable material for the syringe of the present invention.

FIG. 6 is a sectional view showing the outline of the apparatus for manufacturing the main body injection cylinder of the syringe of the present invention. The injection cylinder 63 is a fixed plate 64
2 cores 6 inside the two split pieces 65, 65 '
Inserting 6, 66 ', fix the flat mold 67 on the upper part,
Warm water was poured into the inside 68 of the cores 66, 66 '. The space 70 in the mold corresponds to the shape of the syringe barrel. The raw material synthetic resin, which is the material of the syringe, is mixed with an appropriate mixer, injected as a hot melt at a temperature of 200 to 280 ° C. from the injection ports 69 and 69 ′, extruded into the space 70, pressurized, and then molded. After cooling to a temperature of 70 to 100 ° C. and breaking the mold, a product (in the illustrated example, two cylindrical bodies bound together) is taken out.
According to the present invention, a plurality of cylindrical bodies can be manufactured by a single mold device by molding the synthetic resin in this way,
It is not necessary to assemble each cylinder as in the conventional method. Therefore, the manufacturing method of the present invention is very economical.

As a method of filling a medicine into the syringe of the present invention, for example, each part used as a syringe shown in FIG. 2 is prepared and washed with 0.5% caustic soda or a surface active agent solution. Further, it is washed with ion-exchanged water to clean the inner and outer surfaces of the equipment and the cylinder, and dried in a vacuum chamber. Next, a piston and a cap are assembled in a syringe barrel in a clean room, and a drug solution in which a drug is dissolved in a prescribed concentration with distilled water for injection is separately prepared, and this is vacuum-filled in a syringe. Immediately after filling, the rubber stopper is capped and sealed. Next, treat in a high-pressure steam sterilization tank at a temperature of 121 ° C for 30 minutes, perform labeling and packaging,
Product.

As a single medicinal drug to be stored in the syringe of the present invention, various vitamins, nutritional supplements, antithrombotic agents,
Antibiotics, anticancer agents, analgesics, cardiotonics, hormones, local anesthetics, muscle relaxants and the like can be mentioned. A chemical solution for dissolution or the like is used together with this. In particular, analgesics and anti-inflammatory agents are often used simultaneously with anti-cancer agents, antibiotics, hormones, etc., so they are advantageous when applied to them. Moreover, since the viscosity of hyaluronic acid, mucopolysaccharides or insulins is high, the syringe of the present invention is also suitable for a method of mixing and administering a viscosity adjusting liquid.

Furthermore, the use of the syringe according to the invention for insulins is very advantageous. That is, "insulin injection solution" lasts 3 to 8 with a drug onset time of 0.5 to 1 hour.
Since the “crystalline insulin zinc aqueous suspension injection” has a drug onset time of 4 to 8 hours and the duration of the drug is 36 hours, the insulin injection and the crystalline insulin zinc aqueous suspension injection are described below. When the syringe of the invention is filled and administered simultaneously, the drug effect can be maintained for 1.5 days. In other words, it is a very preferable syringe for diabetic patients who are undergoing home treatment because they need only be administered once every 1.5 days.
It is said that many patients prefer the drug dose of 2: 1. Insulins may be separated into three types.

[0026]

As described above, the present invention has the following effects because it has a structure in which two or more kinds of drugs can be administered hygienically and easily by single needle stick. It has become possible to safely administer and treat a patient's medical condition with a drug with adjusted efficacy even at home. Since a plurality of types of drugs having different medicinal effects can be administered at the same time, the therapeutic effect is fast, long, wide, and flexible and applicable. The ability to administer various drugs with the single needle stick described above,
Since one of the drugs can be used as an analgesic, the pain to the patient can be reduced. Further, the present invention, as a syringe manufacturing method, has a structure that can be injection-molded in the space of one mold, and according to the manufacturing method of the present invention, the production cost is low, which is advantageous in terms of economy, Has the effect.

[Brief description of the drawings]

FIG. 1 is a schematic cross-sectional view illustrating an embodiment of the present invention, in which (a) is a cross-sectional view parallel to the cylinder axis direction of two cylinders,
(B) is a sectional view taken along the line (a) AA ', and (c) is a line taken along the line B-
It is B 'sectional drawing.

FIG. 2 is a schematic cross-sectional view for explaining another embodiment of the present invention, (a) of FIG. 2 shows a cross section parallel to the cylinder axis direction of the injection cylinder, and (b) of FIG. 2A is a sectional view taken along the line CC ', FIG. 2C is a sectional view of the injection needle portion, and FIG.
[FIG. 3] is a cross-sectional view of a pusher.

FIG. 3 is a schematic cross-sectional view illustrating a syringe according to another embodiment of the present invention, (a) showing a cross section parallel to the cylinder axis direction of the injection cylinder part, (b) showing D of (a). -D 'sectional view,
(C) is a cross-sectional view showing an injection needle and an attachment part.

FIG. 4 is a sectional view illustrating still another embodiment of the present invention.

FIG. 5 is a schematic cross-sectional view explaining still another embodiment of the present invention.

FIG. 6 is a schematic cross-sectional view illustrating the method for manufacturing the injection cylinder portion of the syringe of the present invention.

[Explanation of symbols]

1 syringe, 2 and 3 injection cylinder (cylinder), 4 and 5 horizontal bar, 6 space, 7 and 8 tip part,
9 and 10 drug (medicine solution), 1
1 and 12 rubber stoppers, 13 and 14 pistons,
15 ribs, 16 grooves,
17 Pusher, 18 Flange, 19
Cap, 20 Syringe, 21 and 22, Syringe, 23 Tip, 24 and 25
Drug (medicinal solution), 26 rubber stopper, 27 protrusion,
28 and 29 pistons, 30 and 31
Protrusion, 32 and 33 rubber stopper, 34 cap, 35 protrusion,
36 connection body, 37 injection needle, 38 syringe, 39 and 40 injection cylinder, 41 and 42
Tip, 43 rubber stopper,
44 and 45 chemical liquid, 46 connecting pipe, 4
7 soft tube, 48 needle, 49 wing, 50 hub, 51, 52 and 53
Barrel, 54, 55 and 56 drug, 57, 58 and 59
Barrel, 60, 61 and 62 drug.

Claims (10)

[Claims] (1) A plurality of cylinders for accommodating and storing medicines, the tip side of each cylinder being sealed by a sealing means until the time of administration of an injection drug, and the rear end side of each cylinder. An injection cylinder which is filled with the drug and sealed by a piston that is slidable in the cylinder, (2) an injection needle portion having attachment parts of the tip ends of the cylinder bodies, and (3) the cylinder bodies In a syringe having a plurality of pushers arranged in parallel with each other and bound together at a rear end thereof, wherein the plurality of cylindrical bodies have the same or different internal volumes. The objects are arranged in parallel in the cylinder axis direction and a part of the outer peripheral part is fixed by two or more binding means, or the whole outer peripheral part is fixed in one outer peripheral layer, In this case, cover the tip openings of the cylinders with the attachment part of the injection needle part. After the space in the attachment part and the inside of each cylinder are communicated with each other, a plurality of pushers corresponding to the cylinders are press-fitted to flow out the drug in each cylinder into the space in the attachment part through the opening on the tip side. Then, it is allowed to flow out of the syringe through the inside of the needle tube of the injection needle communicating with the internal space of the attachment portion, and the injection cylinder is formed by injection molding once using synthetic resin as a raw material. A syringe characterized in that. 2. The syringe according to claim 1, wherein a space is provided between the plurality of cylinders. 3. The syringe according to claim 1, wherein the plurality of cylindrical bodies are formed in a shape having a plurality of holes penetrating in the axial direction of one rod-shaped material. 4. The syringe according to any one of claims 1 to 3, wherein different types of drugs are contained in each of the plurality of cylinders. 5. The soft tube communicates between the attaching portion and the injection needle, and two wings are attached to the injection needle base portion by a bub at a portion connecting the soft tube and the injection needle. The syringe according to any one of claims 1 to 4, which is characterized. 6. The synthetic resin is one or more selected from the group consisting of an olefin resin, a cyclic olefin compound or a resin containing a cross-linked cyclic hydrocarbon compound as a polymer component. The syringe according to any one of claims 1 to 5. 7. The syringe according to any one of claims 1 to 6, wherein the synthetic resin is a thermoplastic norbornene-based resin. 8. The manufacturing method of a syringe according to claim 1, wherein the injection cylinder is manufactured by injection molding in which molten synthetic resin is injected once into one mold. Manufacturing method of syringe. 9. The synthetic resin is one or more selected from the group consisting of an olefin resin, a cyclic olefin compound or a resin containing a cross-linked cyclic hydrocarbon compound as a polymer component. The method for manufacturing a syringe according to claim 6. 10. The method according to claim 6, wherein the synthetic resin is a thermoplastic norbornene-based resin.
A method for manufacturing the described syringe.