JP2001070445A - Pre-filled syringe - Google Patents

Abstract

PROBLEM TO BE SOLVED: To simplify the structure, to reduce the manufacture cost, to simplify procedures for chemical administration and to reduce waste while securing the certainty of the preservation of a liquid chemical. SOLUTION: For the structure, in this pre-filled syringe whose rear part is sealed by a movable stopper 2, a plug body 5 provided so as to make a liquid chemical passage 3 pass through from an inner side to an outer side seals a plug body holding chamber 7 at a front part by the action of a screw. In this case, for the one for which an opening port 9 provided on a partition plate 10 between a liquid chemical filling chamber 8 and the plug body holding chamber 7 and a passage port 6 shifted from the center of the bottom part of the plug body 5 pressed to the side of the plug body holding chamber 7 of the partition plate 10 and provided are fixed at non-matching positions, the head part of the plug body 5 is rotated with fingers. Thus, the opening port 9 and the passage port 6 are matched and the structure of opening the liquid chemical is attained.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a prefilled syringe which simplifies the structure of a prefilled syringe, while ensuring the preservation of a chemical solution, reducing the cost, reducing the amount of dust, and simplifying the procedure at the time of use. .

[0002]

2. Description of the Related Art In a conventional prefilled syringe, a cap or a cylinder having a double-ended needle is connected to the end of a syringe sealed with a rubber stopper to release a drug solution sealed in the syringe to the outside, and the rubber stopper is penetrated. Or by breaking a welded lid provided at the tip of the nozzle (for example, a plastic cartridge manufactured according to Japanese Patent No. 2846909). Alternatively, a cap provided with a spike or a communicating needle is opened by an operation of fitting the cap in the direction of the closing portion (for example, Japanese Patent Application No. Hei 6-261).
946). Further, as a concept similar to that of a prefilled syringe, a device using a syringe unit as a cartridge with an ampoule filled with a drug solution has been widely used (for example, a dental local anesthetic cartridge and a syringe).

[0003]

In a conventional pre-filled syringe, a chemical solution passage is closed by using a rubber stopper and a metal cap at the tip of a chemical solution holding portion in order to realize a hermetic sealing of the chemical solution, and the chemical solution is opened. For this purpose, a system in which a hollow needle is passed through a rubber stopper is common and structurally complicated. In addition, if it is complicated, the number of parts increases, and the manufacturing cost is higher than when a general disposable syringe and a chemical ampoule are used. In the case of a pre-filled syringe in which the lid is welded to the nozzle of a plastic syringe, the lid is broken by opening the cap to open the medicinal solution. It has not been successful.
In addition, the number of parts is large and the amount of dust is not reduced. Most of the syringes used in dental local anesthesia are syringes with a drug solution cartridge loaded inside.When used in the oral cavity, patient's saliva and blood easily adhere to the syringe, and the same syringe is used for other patients. If used, disinfection was required.

An object of the present invention is to realize a sufficient chemical-sealing property even if the number of parts is simple and the number of parts is small, to simplify the procedure at the time of use, to reduce the cost in production, and to reduce the amount of dust in disposable use. With the goal. Another object of the present invention is to reduce the time required for disinfecting a syringe in a field where a syringe unit containing a cartridge is conventionally used.

[0005]

In order to achieve the above object, in the prefilled syringe of the present invention, at the front of the syringe, a chemical liquid filling chamber and a stopper holding chamber for inserting a bolt-shaped stopper are separated by a partition plate. Separation, the opening of the partition plate,
A screw-shaped plug provided with a chemical passage from the bottom to the outside is screwed into the plug, and when used, the bolt-shaped plug is rotated to join the opening and the chemical passage opening to release the chemical. It is made to be.

The passage opening provided at the bottom of the stopper is provided at a position shifted from the center line of the cylindrical stopper, whereby the passage is rotated about the center line by rotating the stopper, and the opening is opened. It can be moved to a position where it can be joined to, or can be moved to a position where it is not in contact with. Normally, on the plug body holding chamber side of the partition plate,
The bottom of the plug is pressed by a screw at a position where the opening and the passage do not overlap with each other, so that the sealing property of the liquid medicine can be maintained.

When the present invention is used, the head exposed to the outside of the plug is rotated with a finger to make the position of the opening of the partition plate coincide with the position of the passage, and the sealed chemical is released to the outside. .

The invention according to claim 2 employs a method of providing a convex portion on the outer periphery of the head exposed to the outside. The number of the protrusions may be one or more, or the shape of a bar may be used. However, it is recommended that two to four diagonal lines be provided in order to easily turn the plug with a finger hook. Also,
Even if a plurality of concave parts are provided on the circumference of the head part raised to some extent instead of the convex parts, the same shape is obtained, and the same effect can be obtained.

[0009] As a method of making the position of the opening port and the passage port of the partition plate easy to align, in the process of rotating, the convex portion provided at the tip of the syringe main body is attached to the protruding syringe side of the exposed head of the plug body. The recessed portion may be provided with resistance. Further, in order to stabilize the position of the plug at the time of closing, a structure may be employed in which the convex portion and the concave portion are similarly engaged at the position at the time of closing. Furthermore, if you increase the number of turns and make some space between the partition plate and the bottom of the plug,
It is possible to open even if the position of the opening and the passage do not match.

According to a third aspect of the present invention, an injection needle mounting portion is provided at an outer opening of the medical solution passage of the stopper. According to a fourth aspect of the invention, the injection needle is connected to the medical solution passage to the stopper. It is provided. The needle base of the injection needle may be combined with the injection needle attachment portion from the beginning to be integrated.

According to a fifth aspect of the present invention, a cap for protecting the needle is fitted or fastened and fixed to the stopper or the front part of the syringe body by a screw system, a luer lock system, or a luer slip system. And a structure capable of maintaining sterility around the needle part and the sealed part of the drug solution.

[0012] In the invention of claim 6, a convex portion and a concave portion for locking are provided on the outer peripheral surface of the plug body head and the inner surface of the needle protection cap, and the screw-type cap is removed by rotating the bolt-shaped plug directly. The purpose is to make it possible to open the chemical solution by rotating it. If a wing-shaped knob is provided on the outer periphery of the cap, it can be opened with a small force, and the positions of the closed state and the opened state of the chemical solution can be easily grasped. In the case of a shape in which the cap is simply fitted, the concave portion inside the cap may be formed as a convex portion so that the concave portion may be hooked on the convex portion of the plug.

The invention of claim 7 is an invention of a prefilled syringe which enables a plunger rod having a connection screw to be connected to a screw hole of a movable stopper, which is commonly used in the field of the present invention. is there. In general, in a plunger having a screw, a handle is formed in a ring shape, and a suction operation for avoiding erroneous injection of a medical solution into a blood vessel or the like is generally performed.

According to an eighth aspect of the present invention, there is provided a finger hanging flange at the rear end of the present invention. In particular, the present invention having the movable stopper according to the seventh aspect is connected to a plunger rod to form a syringe unit. Is ready to use immediately upon completion.

In the prefilled syringe having a connection portion with the injection aid at the rear end according to the ninth aspect, the injection aid having a plunger rod provided on the main body so as to be movable back and forth is used at the connection portion. It is an invention.

When the injection assistant is manually operated, it requires a finger hook flange on the main body and a handle at the rear end of the plunger rod. An injection assisting device having substantially the same shape as this is commercially available, which is connected to a dental anesthesia cartridge loaded in a needle unit. Also,
If the injection aid is electrically driven, no finger flange or handle is required.

Various methods can be considered for connecting the injection assistant to the present invention, but a luer lock type is recommended because the operation is simple and firmly fixed.

In addition, when a medical solution is injected into a patient, such as when performing anesthesia in dentistry, a suction operation may be required in order to avoid erroneous injection into a blood vessel, etc. In the invention having a screw hole for connecting a plunger rod to the plunger rod, automatic suction is enabled by using a plunger rod having a projection longer than the depth of the screw hole, which is inserted into the screw hole of claim 10.

Specifically, in a movable stopper made of rubber, a screw hole having a depth of about 30% to 40% of the diameter of the stopper from the contact surface of the plunger rod is provided on the side of the chemical solution. If a plunger rod is provided with a protrusion that is 30% to 40% of the diameter of the stopper longer than the depth of the screw hole on the plunger rod side, and pressure is applied, the rubber on the chemical side rises by the length of the hole. It will be. Then, if the force for pushing the rod is reduced, the chemical liquid part becomes negative pressure due to the restoring force of the rubber, and the suction operation is automatically performed. In addition, since the convex portion needs to be movable back and forth in the screw hole, it is recommended that the protrusion has no thread and is smaller than the inner diameter of the screw hole. In this case, there is no problem even if the screw hole of the stopper is a simple cylindrical hole.

It is not necessary to make the outer diameter of the liquid filling chamber equal to the outer diameter of the plug holding chamber. However, when the volume of the liquid filling chamber is large and the outer diameter is large, the outer diameter of the plug holding chamber is larger. small,
When the capacity of the chemical liquid filling chamber is small and the outer diameter is small, it is preferable to form a continuous cylindrical shape.

Further, it is not always necessary to make the center lines of the liquid medicine filling chamber and the stopper holding chamber coincide with each other. For example, when the outer diameter of the liquid filling chamber is larger than the outer diameter of the stopper holding chamber, if the opening is provided at the center line position of the liquid filling chamber, the center line of the stopper holding chamber must be displaced from the center line. The rotation of the plug prevents the passage opening from being aligned with or separated from the opening.

Although the material of the present invention is not particularly limited, it can be made of a material such as polypropylene, polyethylene or polyethylene terephthalate. In general, polyethylene is preferred.

Although the stopper of the present invention is described as a bolt, it is possible to cut a screw into a columnar stopper and rotate the stopper into a screw hole-shaped stopper holding chamber or open the stopper. For this purpose, the head does not necessarily need to have an umbrella-shaped large diameter if it can be easily rotated. In addition, if the bottom surface of the plug is made of an elastic material such as rubber, the sealing performance is maintained even if the pressing force against the partition plate is relatively small.

[0024]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Embodiments of the present invention will be described based on embodiments with reference to the drawings. FIG. 1 shows a prefilled syringe main body 1 according to the present invention, in which a rear portion has a movable stopper 2.
In the bottom part 4 of the bolt-shaped plug body 5 in which the chemical solution passage 3 is penetrated from the bottom part 4 to the outside at the front part, the passage opening 6 is displaced from the center line of the cylindrical plug body 5. The plug holding chamber 7 closed by the provided plug 5
And a liquid medicine filling chamber 8 partitioned by a partition plate 10 having an opening 9. In the present invention, the bottom 4 of the plug 5 is strongly pressed and fixed to the partition plate 10 by the action of the threads provided on the inner circumferential surface of the plug holding chamber 7 and the outer peripheral surface of the plug 5 respectively. I have. In this state, the open port 9 of the partition plate 10 and the passage port 6 of the plug 5 are in a position where they do not overlap, and are in a sealed state in which the chemical solution cannot pass.

In order to release the chemical solution so that it can be poured out, the stopper 5
A force is applied to the head 11 exposed to the outside with a finger to rotate the stopper 5 about half a turn, and the stopper is stopped at the position where the opening 9 and the passage 6 are aligned. Is opened via the chemical solution passage 3 penetrating through the inside. FIG. 3 shows a perspective view so that the shape of the plug 5 can be easily grasped.

In this figure, a needle base 14 having an injection needle mounting portion 12 and an injection needle 13 is installed outside the stopper 5 so as to be connected to the drug solution passage 3. Is provided, and a finger hanging flange 16 is provided at the rear portion of the syringe, so that a threaded plunger rod can be connected to immediately use the patient.

The position of the opening 9 of the partition plate 10 may be any position provided that there is no overlapping portion at the position farthest from the passage opening 6 and the overlapping portion is maximized at the time of opening. It is recommended to place them at a position shifted from the center line of the, because it is possible to increase the distance between them at the time of sealing.

FIG. 2 shows a cap 18 for needle protection joined to a luer lock joint 17 on the outer periphery of the distal end of the syringe body 1b. The groove 20 is cut so that an elastic claw 19 provided on the outer periphery of the hook 11 is hooked in a direction to remove the cap. Since the claw 19 is angled, it does not engage with the rotation of closing the cap 18 and the stopper 5 does not rotate. Also,
A convex portion 21 is provided on the plane of the end of the syringe main body 1b, and a concave portion 22 is provided on a plane of the plug head 11 on the side of the syringe so that the concave portion 22 engages with the convex portion 21 at the chemical solution opening position and is fixed. .

In this case, when the cap 18 is rotated to remove the cap 18, the claw 19 of the plug head 11 is engaged with the groove 20 on the inner surface of the cap 18, and the plug 5 is also rotated. At the position where the syringe is turned by half a turn, the convex portion 21 of the syringe and the concave portion 22 of the plug head 11 engage with each other, and the plug 5 is fixed at the chemical solution opening position.
The distance that the cap 18 moves in the direction of the needle tip due to the rotation is longer than the distance that the plug body 5 moves with the screw in the outward direction due to the luer lock, and the groove 20 of the cap 18 is disengaged from the claw 19 at the time of half rotation. It is like that. Further, on the outer periphery of the rear end of the present invention, there is provided a connecting portion 24 connected to the injection assistant. When the present invention is used, the connection 2
After connecting the connecting portion 25 of the injection assistant tool body 4 to 4,
The stopper 5 is also rotated at the same time as the stopper 18 is rotated in the direction to remove the needle protecting cap 18, and the stopper 5 is fixed at the chemical solution opening position, the chemical solution is opened and the preparation is completed. The groove 2
The same effect can be obtained even if 0 is a claw-shaped projection and the claw 19 is hooked in a certain direction. FIG. 4 shows a cross-sectional view of an example of the injection assistant.

[0030]

Since the present invention is configured as described above, it has the following effects.

Since the liquid medicine sealed by the plug at the front part of the prefilled syringe can be opened only by turning the plug a little half a turn, the time required for drug administration can be greatly reduced.

Further, as described above, the chemical solution sealing and opening system can be realized with a smaller number of parts than the conventional prefilled syringe, and the manufacturing cost can be reduced.

If a convex portion for hooking a finger is provided on the head of the plug, it is possible to easily rotate the normally tightly closed plug, and it is also possible to grasp the opening position of the chemical in the direction of the convex portion. Useful.

It is important for the purpose of the present invention to provide an injection needle attachment portion on the stopper or to provide an injection needle from the beginning. In particular, providing an injection needle from the beginning and providing it to the medical site enables simplification of the procedure in medical practice and a reduction in the amount of medical waste by combining the injection needle storage container and the syringe storage container.

It is effective to keep the needle protecting cap attached to the inside with high airtightness for preserving the sterilized needle. In addition, by performing the manufacturing process of the internal structure of the cap aseptically, the entire present invention can be sterilized. Eliminates the need for containers to be kept in state, and therefore eliminates the need for disinfection during use.

For example, when the present invention is used for dental anesthesia, it is significant that all the parts entering the oral cavity can be used as disposable. Conventional anesthetic cartridges and needles are disposable, but since the syringe cartridge is inside the syringe, the syringe contaminated with saliva and blood of the patient in the oral cavity must be disinfected each time. In addition, there are many procedures in preparation for injection of an anesthetic in a dentist. First, the rubber film at the needle stick portion of the cartridge is disinfected with alcohol or the like. Next, the cartridge is loaded into the syringe, and then the container on the cartridge side of the injection needle is removed, and the syringe is mounted on the syringe. Then remove the remaining containers. With the present invention having an aseptically manufactured needle and protective cap interior, there is no need to disinfect the seal. Further, when using the invention having the protective cap that engages with the plug according to claim 6 in the procedure, the preparation is completed only by the operation of removing the protective cap, and the operation for mounting the needle is not required.

In the case of the invention in which the injection assisting device is connected, the injection assisting device can be used repeatedly, which contributes to reducing the cost of the plunger rod and the finger flange portion and reducing the waste volume. At the same time, it is possible to make the shape easy for the operator to hold and operate,
This will help improve the accuracy of the procedure.

More recently, electric injectors have become widespread in dental anesthesia, enabling stable injection rates and minute injections, which are difficult to perform manually. In the configuration having the injection needle at the rear end connection of the present invention, a simpler shape of the power injector conforming to the present invention can be designed.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a prefilled syringe of the present invention.

FIG. 2 is a longitudinal sectional view of an embodiment in which a cap capable of rotating a stopper and a connection part of an injection assistant are provided in the present invention.

FIG. 3 is a perspective view of a plug.

FIG. 4 is a longitudinal sectional view of an example of an injection assistant.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1, 1b Prefilled syringe main body 2 Movable stopper 3 Chemical liquid passage 4 Plug body bottom part 5 Plug body 6 Passage port 7 Plug body holding room 8 Chemical liquid filling room 9 Opening port 10 Partition plate 11 Plug body head 12 Injection needle attachment part 13 14 Needle base 15 Screw hole 16 26 Finger hanging flange 17 Luer lock joint 18 Cap 19 Claw 20 Groove 21 Convex part 22 Concave 23 Injection aid main body part 24 25 Connection part 27 Plunger rod 28 Handle 29 Stopper contact surface 30 Plunger convex Department

Claims (10)

[Claims] 1. A syringe rear portion is closed by a movable stopper (2), and a stopper holding chamber (7) at a front portion of the syringe is provided with a chemical liquid passage (6) from a passage opening (6) provided at a position shifted from the center of the bottom. 3) A chemical liquid filling chamber (8) which is closed by a bolt-shaped plug (5) penetrating therethrough and is partitioned by a partition plate (10) having an opening (9) opening to the plug holding chamber (7). The plug (5) fixed at a position where the opening (9) and the passage opening (6) do not come into contact with each other by the action of a screw is rotated by applying force to the head (11) exposed to the outside. Align the opening (9) with the passage (6),
A prefilled syringe characterized in that a drug solution can be opened from an opening (9) through a drug solution passage (3) by creating a space between the plug bottom (4) and the partition plate (10). 2. The pre-filled syringe according to claim 1, wherein a radially convex portion is provided on the outer periphery of the head of the plug (5). 3. The prefilled syringe according to claim 1, wherein an injection needle mounting portion (12) is provided at an outer opening of the medical solution passage (3) of the stopper. 4. A prefilled syringe according to claim 1, wherein said syringe is connected to said liquid passage, and said plug is provided with an injection needle so that said liquid can be poured out. 5. The prefilled syringe according to claim 4, further comprising a needle protection cap (18) having a structure to be joined to the stopper (5) or the syringe body (1). 6. The needle protection cap (18) is provided with a plug body head (1).
The pre-filled syringe according to claim 5, wherein the stopper (5) can also be rotated by being partially locked to (1) and rotated. 7. The prefilled syringe according to claim 1, wherein a screw hole (15) for connecting a plunger rod to the movable stopper (2) is provided on a rear end face. 8. The prefilled syringe according to claim 1, wherein a finger hook flange is provided at a rear portion of the syringe. 9. A main body (2) having a connecting portion (25) at a tip thereof.
3. A connecting part (24) for connecting at the rear end with an injection aid consisting of a plunger rod (27) attached to the body part so as to be movable back and forth in the front-rear direction. Prefilled syringe. 10. A stopper contact surface provided with a plunger projection (30) longer than the length of a screw hole, which can be used in a prefilled syringe having a movable stopper (2) having a screw hole (15) according to claim 7. An injection aid or plunger rod having (29).