JPH08294532A - Prefilled syringe - Google Patents

Abstract

PURPOSE: To provide a prefilled syringe usable as a two-pack type and a one- pack type as well by providing the inside of the outside cylinder of a syringe with a front part gasket contg. a closing body, a rear part gasket freely mountable with a plunger and a closing body extruding means mounted at the rear end of an injection needle mounting member. CONSTITUTION: The plunger 9 is pushed forward while the distance between the front part gasket 5 and the rear part gasket 7 is maintained and a liquid medicine (x) is injected from the hypodermic needle 8 when the plunger 9 is pushed at the time of use in the case the medicinal liquids (x), (y) are used. The front part gasket 5 exists at the front end of the outside cylinder 1 of the syringe and the closing body 6 in the front part gasket 5 comes into contact with a closing body extruding member 3 when the medicinal liquid (x) is discharged. Only the front part gasket 5 advances and the bypass path of the front part gasket 5 is communicated with the medicinal liquid passage of the hypodermic needle mounting part 2 through the opening 31 of the closing body extruding member 3 when the plunger 9 is further pushed from this state. The medicinal liquid (y) is then discharged from the injection needle 8.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to prefilled syringes. More specifically, the present invention relates to a prefilled syringe which is a syringe used for administering a medicinal solution in a hospital or the like, and which is preliminarily filled with the medicinal solution and ready to be used at the time of use.

[0002]

2. Description of the Related Art There are one-pack type and two-pack type prefilled syringes, but as a conventional technique (conventional example I) of a two-pack type prefilled syringe, Japanese Utility Model Publication No. 49-14465 and Japanese Patent Publication No. 6-14756. Some are described in the official gazette.
The basic configuration of these prefilled syringes is shown in FIG.
As shown in FIG. 5, when the bypass passage 152 is recessed in the inner wall of the central portion of the syringe outer cylinder 151 and the plunger 153 is pushed in, the liquid B (for example, the dissolution liquid) between the gasket 154 and the plunger 153 is generated by the gasket 154. Bypass groove 15 in front
It enters through 2 and is mixed with dry drug A (eg, antibiotic). Further, as a conventional technique (conventional example II) for a one-pack type prefilled syringe, Japanese Patent Laid-Open No. 49-
68586, JP-B-52-38067 and JP-B-58-126839. A description will be given with the one disclosed in JP-A-49-68586 as a representative. As shown in FIG. 10, when a double-ended needle p is attached to the tip of a syringe a with a cap 201 and a plunger c is pushed in, a rubber plug (diaphragm) 204 is attached. Is punctured, and the filled drug solution g can be injected through the double-ended needle p. In both the two-component type conventional example I and the one-component type conventional example II, the drug solution is stored by sealing with a rubber stopper until the time of use, and the rubber stopper is punctured with a double-ended needle at the time of use. Have in common.

[0003]

However, the above-mentioned conventional examples I and II have the following problems. In Conventional Example I,
There is a problem that the bypass groove 152 of the syringe outer cylinder 151 is difficult to process and the manufacturing cost is high, and the pre-filled syringe outer cylinder of the large-capacity type is a glass container, which is difficult to process and is not feasible. . In Conventional Example II, coring that occurs when a rubber stopper is punctured with a double-ended needle is unavoidable, and there is a problem that foreign matter is mixed into the injection solution by the coring. Further, in the case of using a metal double-ended needle, there is a problem that the metal needle is fixed in advance with an adhesive or the like, and there is a problem that the syringe body and the double-ended needle cannot be separately discarded for separate disposal.

In view of such circumstances, the present invention provides a prefilled syringe which is easy and inexpensive to manufacture, is capable of manufacturing a large-capacity type, has no coring, and is capable of separating and discarding injection needles. The purpose is to Also,
The conventional prefilled syringes, both of which are a two-component type and a one-component type, have no special purpose and cannot be used in common, but the present invention provides a dual-type prefilled syringe which can be used as a one-component type. With the goal.

[0005]

A prefilled syringe of the present invention comprises a syringe outer cylinder having both ends open, an injection needle mounting member provided at the front end of the syringe outer cylinder, and a liquid-tight seal inside the syringe outer cylinder. The front gasket having a built-in closure body inserted thereinto, the rear gasket that is liquid-tightly inserted into the rear end of the syringe outer cylinder and on which the plunger can be attached, and the rear end of the injection needle attachment member. The front gasket includes a liquid passage extending axially through the front gasket, and a front accommodating portion for accommodating the closure at the front of the liquid passage to close the liquid passage. A rear accommodating portion for accommodating the closing body, and a bypass passage that bypasses the rear accommodating portion and communicates with the front accommodating portion, are formed in a rear portion of the liquid medicine passage, Front gasket When pushed into the front end of the outer cylinder, in contact with the closure body in the front housing portion of the front gasket, characterized in that it is a member for pushing the rear housing portion. Further, in the present invention, the first chemical liquid is filled between the front end of the syringe outer cylinder and the front gasket, and the second chemical liquid is filled between the front gasket and the rear gasket.
It can also be used as a liquid type prefilled syringe,
It can also be used as a one-liquid type prefilled syringe which is used by filling only the first chemical liquid between the front gasket and the rear gasket in the syringe outer cylinder.

[0006]

According to the present invention, when an arbitrary injection needle is attached to the injection needle mounting member and the plunger is joined and pushed into the rear gasket, the pushing force is exerted through the liquid medicine between the front gasket and the rear gasket. The front gasket slides to the front end inside the syringe outer cylinder. During this time, the closing body in the front gasket is housed in the front housing part and closes the chemical liquid passage in the front gasket.
When the front gasket reaches the front end of the syringe outer cylinder, the tip of the closing body pushing means attached to the rear end of the injection needle attaching member abuts the closing body, and moves the closing body to the rear housing portion. . As a result, the chemical liquid passage of the front gasket is opened through the bypass passage, so that the chemical liquid can be injected between the front gasket and the rear gasket. Therefore, in the two-component type prefilled syringe, the first drug solution is injected by initial pushing, and then the second drug solution is injected when the drug solution passage of the front gasket is opened as described above. In the one-liquid type prefilled syringe, the drug solution is injected after the drug solution passage of the front gasket is opened. In the present invention, since the release of the drug solution is controlled by the front gasket, the conventional example I is attached to the syringe outer cylinder.
Since it is not necessary to process the bypass groove as described above, the processing is easy and the manufacturing cost is low. Moreover, since a cylindrical syringe outer cylinder is used, a large capacity type can be manufactured. Furthermore, since the front gasket is communicated by pushing the closing body in the drug solution passage, there is no room for foreign matter mixing because coring such as puncturing a rubber stopper with an injection needle does not occur. Further, since a double-headed needle is not used and a general injection needle is attachable, it is possible to separate and discard the injection needle and the syringe body separately.

[0007]

Embodiments of the present invention will now be described with reference to the drawings. 1 is an explanatory view of a first liquid medicine injection operation of a two-liquid type prefilled syringe A according to one embodiment of the present invention, FIG. 2 is an explanatory view of a front gasket opening operation of the same prefilled syringe A, and FIG. 2 is an explanatory view of the injection operation of the drug solution, FIG. 4 is an explanatory view of the injection completed state, and FIG.

First, the structure of the prefilled syringe A in the storage state before use will be described with reference to FIG. Reference numeral 1 denotes a syringe outer cylinder, which is a cylindrical member made of glass and having both ends opened, and annular projections 11 and 12 are formed on the outer circumference of the front end and the outer circumference of the rear end. An injection needle attachment member 2 is attached to the front end of the syringe outer cylinder 1. The injection needle mounting member 2 has a disk-shaped top surface 21 and a skirt portion 22 formed on the outer periphery of the top surface 21.
The skirt portion 22 is formed with an engaging projection 23 projecting inward on the lower end circumference thereof. The engagement protrusion 23 engages with the annular protrusion 11 of the syringe outer cylinder 1, and the injection needle mounting member 2
Is firmly attached to the syringe outer cylinder 1, and liquid-tightly seals the front end of the syringe outer cylinder 1. If necessary, packing may be interposed between the front end of the syringe outer cylinder 1 and the injection needle mounting member 2. Further, a luer tip (24) is formed so as to project outward from the center position of the top surface (21), and a female screw cylinder (25) for concentrically screwing a screw thread at the base of the injection needle is formed on the outside thereof. A fitting type in which the lure tip 24 and the injection needle are tightly fitted together may be used. In that case, the female screw cylinder 25 is not necessary. The present invention has an advantage that any type of injection needle can be used by using the lure tip 24.

Further, a closing body pushing member 3 is formed so as to project inward from the center position of the top surface 21. The push-out member 3 is for pushing out a closing body 6 in a front gasket 5 described later from a closed position to an open position, and an opening 31 (a slit in the example shown in the drawing) for passing a chemical solution is formed in a side wall of a tip end portion thereof. Is formed). A chemical liquid passage 27 is formed by penetrating the lure tip 24 and the closing body pushing member 3. It should be noted that the injection needle mounting member 2 has a rubber cap for preventing contamination of the luer tip 24 and the female screw cylinder 25 when the prefilled syringe A is not used and for preventing leakage of the drug solution in the syringe outer cylinder 1.
26 is supposed to be covered.

A flange 4 is provided at the rear end of the syringe outer cylinder 1.
Is installed. The flange 4 includes a fitting tubular portion 41, a flange portion 42 for hooking the index finger and the middle finger of the hand, and an engaging tubular portion 43 for locking a rear end cover 44 described later. The rear end cover 44 is a cylindrical cover that is attached to prevent the rear gasket 7 from being contaminated when the prefilled syringe A is not used and stored.

A front gasket 5 and a rear gasket 7 are inserted in the syringe outer cylinder 1. The front gasket 5 is composed of a rubber stopper 51, and a chemical passage 52 that penetrates in the axial direction is formed in the stopper 51. A front accommodation portion 53 for accommodating the closing body 6 is formed in the front portion of the chemical passage 52. The rear housing portion 54 is formed in the rear portion. The closing body 6 is a bullet-shaped or spherical member made of plastic or the like, which is initially inserted in the front accommodation portion 53, and moves to the rear accommodation portion 54 when the stopper is opened, as will be described later, and the chemical solution of the front gasket 5 is added. It controls the opening and closing of the passage 52. A bypass passage 55 is formed in the rear accommodation portion 54, and the bypass passage 55 is formed.
Communicates from the rear end of the front gasket 5 to the chemical liquid passage 52 between the front accommodation portion 53 and the rear accommodation portion 54. Therefore, when the closing body 6 is located in the front accommodation portion 53, the chemical liquid passage 52
Is closed, and when the closing body 6 moves into the rear accommodating portion 54, the front and rear of the front gasket 5 communicate with each other through the bypass passage 55 and the chemical liquid passage 52. The rear gasket 7 is a known gasket, in which a female plug 72 for screwing a plunger described later is formed in a rubber stopper 71.

Since the prefilled syringe A of this embodiment is a two-liquid type, as shown in the figure, the front gasket 5 is inserted in the approximate center of the syringe outer cylinder 1, and the rear gasket 7 is the rear end of the syringe outer cylinder 1. Inserted in. Then, the space between the front gasket 5 and the injection needle mounting member 2 becomes the first liquid chamber X, the first chemical liquid x is filled, and the space between the front gasket 5 and the rear gasket 7 becomes the second liquid chamber Y, The second chemical liquid y is filled. That is, it is stored in the illustrated state from the time it is manufactured until it is used. There are various kinds of chemicals to be used, but when an anesthetic is used as the first chemical x, a highly viscous chemical is used as the second chemical y, and when a glucose solution is used as the first chemical x, the second chemical y is used. It is typical to use an amino acid solution as.

Next, a method of operating the prefilled syringe A of this embodiment will be described with reference to the case where an anesthetic is used as the first chemical liquid x and a highly viscous chemical liquid is used as the second chemical liquid. Figure 5
In the storage state shown in, the rubber cap 26 and the rear end cover
44 is removed, the injection needle 8 is attached to the luer tip 24, and the plunger 9 is attached to the rear gasket 7, as shown in FIG. The injection needle 8 is a general injection needle and has a hub.
A canula 82 is attached to 81, and a male screw portion 83 is formed on the outer periphery of the rear end of the hub 81. Therefore, the injection needle 8 can be firmly fixed by screwing it into the female screw cylinder 25. In the case of a fitting type coupling structure, the hub of the injection needle 8 may be firmly inserted into the luer tip 24, or further rotated and fixed. The plunger 9 is a known one, and a male screw portion 92 is formed at the front end of the rod 91, and a finger rest portion 93 is formed at the rear end. By screwing the male screw portion 9 of the plunger 9 into the female screw portion 72 of the rear gasket 7, they can be firmly coupled to each other.

When the preparation for injection is completed as described above, the syringe outer cylinder 1 and the plunger 9 are held with one hand, the index finger and the middle finger are hooked on the flange 4, and the plunger 9 is pushed with the thumb. Due to the incompressibility of the liquid, the front gasket 5 is pushed forward while maintaining the distance from the rear gasket 7. As a result, the first drug solution x in front of the front gasket 5 is directly injected into the patient's body from the injection needle 8.

When most of the first chemical liquid x is discharged as described above, the front gasket 5 is located at the tip of the syringe outer cylinder 1 and the front accommodation portion 53 thereof, as shown in FIG. The inner closing body 6 contacts the closing body pushing member 3. When the plunger 9 is further pushed in from this state, only the plug body 51 of the front gasket 5 advances, so that the closing body 6 moves into the rear storage chamber 54 as shown by the arrow c. FIG. 3 shows a state in which this movement is completed, and when the movement of the closing body 6 to the rear storage chamber 54 is completed in this manner, the front gasket 5
The bypass passage 55 communicates with the liquid medicine passage 27 of the injection needle mounting member 2 through the opening 31 of the closing body pushing member 3. Therefore, by further pushing the plunger 9, the second drug solution y can be directly injected into the patient's body from the injection needle 8. When the plunger 9 is pushed all the way in, the rear gasket 7 abuts on the rear end of the front gasket 5 and stops, as shown in FIG. 4, and injection of all the drug solution is completed.

After the injection is finished, if the injection needle 8 is unscrewed and removed from the injection needle mounting member 2, the injection needle 8 and the syringe body side can be easily separated and discarded. When a glucose solution is used as the first chemical solution and an amino acid solution is used as the second chemical solution, the mixture is injected into a mixing bag by the same operation and mixed in this bag before being used for drip therapy.

Next, another embodiment of the present invention will be described.
6 is an explanatory view of a front gasket opening operation of a one-pack type prefilled syringe B according to another embodiment of the present invention, FIG. 7 is an explanatory view of a drug solution injection operation, and FIG. 8 is the same in a storage state before use. It is a longitudinal cross-sectional view of the prefilled syringe B.

As shown in FIG. 8, the structure of each part of the prefilled syringe B of this embodiment is substantially the same as that of the prefilled syringe A of the above embodiment shown in FIG. The difference is that the liquid medicine is not filled between the front gasket 5 and the injection needle mounting member 2, but one kind of liquid medicine z is filled only between the front gasket 5 and the rear gasket 7. is there. Unlike the two-liquid type, the type of the chemical liquid z is not particularly limited, and various chemical liquids can be used. Therefore, the same reference numerals are given to the same components and duplicated description will be omitted. In the present embodiment, the front gasket 5 is usually inserted from the beginning into the front end position in the syringe outer cylinder 1 so as to increase the drug solution filling volume between the front gasket 5 and the rear gasket 7.

Next, the injection operation of the prefilled syringe B of this embodiment will be described. First, as in the previous embodiment, the rubber cap 26 and the rear end cover 44 are removed, the injection needle 8 is attached to the luer tip 24, and the plunger 9 is connected to the rear gasket 7 as shown in FIG. Then, the plunger 9 is pushed in. By the first pushing operation of the plunger 9, the front gasket 5 advances, and the closing body 6 cannot move forward because it is in contact with the closing body pushing member 3, so that the closing body 6 relatively moves as shown by an arrow c. It moves from the front accommodation part 53 to the rear accommodation part 54. FIG. 7 shows a state in which this movement is completed. When the movement of the closing body 6 to the rear accommodation chamber 54 is completed, the bypass passage 55 of the front gasket 5 passes through the opening 31 of the closing body pushing member 3 and the injection needle mounting member 2 is inserted. Communicates with the chemical liquid passage 27. Therefore, when the plunger 9 is further pushed, the drug solution z can be injected into the patient's body from the injection needle 8. When the plunger 9 is pushed all the way in, the rear gasket 7 hits the rear end of the front gasket 5 and stops,
Complete the injection of the full volume of drug solution. After the injection is finished, if the injection needle 8 is unscrewed and removed from the injection needle mounting member 2, the injection needle 8 and the syringe body side can be easily separated and discarded.

[0020]

According to the present invention, it is possible to provide a prefilled syringe which is easy to manufacture, low in cost, capable of manufacturing a large-capacity type, does not cause coring at all, and is capable of separating and discarding injection needles. In addition, the present invention is also applicable to a two-pack type
It is possible to provide a dual-use prefilled syringe that can also be used as a liquid type.

[Brief description of drawings]

FIG. 1 is an explanatory diagram of a first liquid medicine injection operation of a two-liquid type prefilled syringe A according to an embodiment of the present invention.

FIG. 2 is an explanatory diagram of a front gasket opening operation of the same prefilled syringe A.

FIG. 3 is an explanatory diagram of a second chemical solution injection operation of the prefilled syringe A.

FIG. 4 is an explanatory diagram of an injection completed state of the prefilled syringe A.

FIG. 5 is a vertical sectional view of the prefilled syringe A in a storage state before use.

FIG. 6 is an explanatory diagram of a front gasket opening operation of the one-liquid type prefilled syringe B according to another embodiment of the present invention.

FIG. 7 is an explanatory diagram of a drug solution injection operation of the prefilled syringe B.

FIG. 8 is a vertical cross-sectional view of the prefilled syringe B in the storage state before use.

9 is an explanatory diagram of a prefilled syringe of Conventional Example I. FIG.

FIG. 10 is an explanatory diagram of a prefilled syringe of Conventional Example II.

[Explanation of symbols]

1 Syringe outer cylinder 2 Injection needle mounting member 3 Closure body push-out member 4 Flange 5 Front gasket 6 Closure body 7 Rear gasket 8 Injection needle 9 Plunger

Claims (3)

[Claims] 1. A syringe outer cylinder having both ends opened, an injection needle mounting member provided at a front end of the syringe outer cylinder, and a closed body which is liquid-tightly inserted into the syringe outer cylinder. A part gasket, a rear gasket that is liquid-tightly inserted into the rear end of the syringe outer cylinder and can be fitted with a plunger, and a closing body pushing means attached to the rear end of the injection needle mounting member, The front gasket includes an axially penetrating chemical liquid passage, a front accommodating portion for accommodating the closing body to close the chemical liquid passage at a front portion of the chemical liquid passage, and a closing body at a rear portion of the chemical liquid passage. Is formed, and a bypass path that bypasses the rear housing portion and communicates with the front housing portion is formed, and in the closing body pushing means, the front gasket is a front end portion inside the syringe outer cylinder. Front gasket when pushed into Of contact with the closure body in the front housing portion, a pre-filled syringe, characterized in that it is a member for pushing the rear housing portion. 2. A two-liquid type in which a first chemical liquid is filled between the front end and the front gasket of the syringe outer cylinder, and a second chemical liquid is filled between the front gasket and the rear gasket.
The prefilled syringe described. 3. The prefilled syringe according to claim 1, which is a one-liquid type in which a first chemical liquid is filled between a front gasket and a rear gasket in the syringe outer cylinder.