JPH0739583A - Two medical components premixing type syringe - Google Patents

Abstract

PURPOSE:To provide a two medical components type injector including two components capable of being mixed, wherein the injector possesses characteristics of ready assembling, applicable to optional needles, pre-filling a medical component and a dissolving fluid separately, capable of sterilizing a dissolving fluid after the filling and readily mixing two components. CONSTITUTION:The injector is composed of a vial 1 sealed with a rubber stopper 11, a communicating needle 2 comprising a Luer tip 21 and a needle 22, a syringe 3 equipped with both a rubber stopper 31 at one end and a plunger 34 at the other end, a cap 4 comprising the body 4a including a vial 1 sealed with a rubber stopper 11 and an extention cylinder having engaging grooves 41 and 42 on the inner face, a guiding member 5 wherein the communicating needle is held directing the piercing needle 22 toward the syringe side and the Luer tip 21 toward the vial in the tip end part of the cylinder part 5a, and having a protruding projection on an engaging piece 5b, and a holder 6.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a two-component mixed drug prefilling syringe. More specifically, the present invention relates to a drug prefilling syringe in which a drug and a solution thereof are kept airtight and aseptically before administration and are mixed at the time of use.

[0002]

2. Description of the Related Art As an example of a conventional drug prefilling syringe,
There are one disclosed in Japanese Patent Laid-Open No. 5-31189 (conventional example I) and one disclosed in Japanese Patent Publication No. 5-27426 (conventional example II).
As shown in FIG. 11, the drug prefilled syringe of Conventional Example I has an injection needle 141 fixed to the tip, a plunger 145 slidably inserted from the rear end opening, and a powder drug P inside. And an outer cylinder 120 in which a distal end of the injection cylinder 149 is slidably inserted through a rear end opening and a pierceable seal member 121 is attached to the front end opening.
A second component chamber 110 that is airtightly attached to the tip of the outer cylinder 120 with the seal member 121 interposed therebetween, and that contains the dissolving liquid L therein, and is attached to and detached from the rear end opening of the outer cylinder 120. A cover 150, which is freely mounted and cooperates with the outer cylinder 120 to hermetically cover the injection cylinder 149 and the plunger 145, is provided.

When using the above-mentioned drug prefilling syringe, the cover 150 is pushed with a strong force to break the base of the cover 150 at the notch groove 153, and the plunger together with the cover 150 is broken.
145 is pushed in and the seal member 111 of the second component chamber 110 is punctured with the injection needle 141. In this way, the second component chamber 110
The solution L therein is made aspirable, and the plunger 145 of the syringe body 140 is once pulled back in the opposite direction to introduce the solution into the syringe barrel 149 to dissolve the powder drug. Then, from the syringe body 140 to the outer tube 120 and the cover 150.
The syringe body 140 is removed and used as a syringe.

In the injector of Conventional Example II, as shown in FIG. 12 (A), a bypass plug 231 is inserted approximately in the middle of a syringe barrel 222, and a plunger 237 having a plug member 236 at the rear end is inserted to perform injection. A bypass passage 234 is formed between the tip of the cylinder 222 and the bypass plug 231. The compartment in which the bypass passage 234 is formed is the second medicine chamber f for containing the powdered medicine, and the space between the bypass stopper 231 and the stopper member 236 of the plunger 237 is the first medicine chamber e for containing the solution. When using
When the plunger 237 is pushed in as shown in (B), the bypass plug 231 advances, and the lysate flows through the bypass passage 234 to the first position.
It flows from the medicine chamber e into the second medicine chamber f to dissolve the powdered medicine.

[0005]

However, the conventional drug prefilling syringe of the conventional example I has the following problems. Since many assembling steps are required, the assembling work is troublesome and the assembling work efficiency is reduced. Since the injection needle 141 is incorporated inside, the injection needle cannot be freely selected. Further, in the case of the drug prefilling syringe of the conventional example II, since the powder drug and the dissolution liquid have to be separately prefilled in the same syringe, the assembly process is not easy, and the dissolution liquid is filled. There was a problem that it could not be sterilized.

In view of such circumstances, the present invention facilitates the assembling, improves the efficiency of the assembling work, enables the use of a freely selected injection needle, and enables the powder or liquid drug and the solution to be dissolved. It is an object of the present invention to provide a drug prefilling syringe which can be prefilled separately and sterilized by dissolving solution after filling, and which can easily mix both.

[0007]

A two-component mixed-type drug prefilling syringe of the present invention is a bottomed cylindrical vial having one end open and a rubber stopper closed at the open end, and a luer tip at one end. And a communicating needle having a piercing needle formed at the other end and a cylindrical member, the front end of which is closed by a pierceable rubber stopper, the rear end is open, and a flange is formed on the outer periphery of the rear end. A syringe in which a plunger provided with a gasket is inserted from a rear end opening and a bottomed cylindrical body body and an extension body, and the vial is provided in the body body. A cap having the first engagement groove formed on the opening end side and the second engagement groove formed on the substantially central portion on the inner peripheral surface of the extension barrel portion. And the connecting piece at the tip side of the cylindrical portion, and the luer of the communicating needle. The tip is directed toward the vial side, the piercing needle is directed toward the syringe side, and the distal end portion of the syringe is slidably accommodated in the opening side portion of the cylindrical portion. The syringe is composed of a guide member having an engagement protrusion that selectively engages with the engagement groove and the second engagement groove, and a holder composed of a main body and an engaging / disengaging piece, the main body of the holder being the syringe. Is a member for holding the flange and the rear end of the plunger, and the engagement / disengagement piece is a member for biasing the engagement piece of the guide member inward to disengage from the first engagement groove. The rubber stopper has a passage formed in the axial direction and the closing body is inserted therein.When the closing body is pushed by the luer tip of the communicating needle, the closing body is moved from the closed position to the open position. First drug pre-filled with powder or liquid drug , And the wherein the vial is a second drug compartment the drug solution or liquid is prefilled.

[0008]

In the two-component mixed-type drug prefilling syringe of the present invention, the vial having the second drug chamber is held in the body of the cap, and the first body is formed on the inner peripheral surface of the extension barrel of the cap.
The engagement protrusion of the guide member is engaged with the engagement groove, the communicating needle is held at the tip end side portion of the guide member, and the tip end portion of the syringe having the first drug chamber formed at the opening side portion is slidably accommodated. Therefore, it is possible to easily assemble the drug and the solution separately and independently in the pre-filled state in the first and second drug chambers.

Further, when the holder is pushed into the cap, the rubber stopper of the syringe is pierced by the piercing needle, and when the holder is pushed further into the cap, the engaging protrusion of the guide member causes the engaging projection of the guide member to move. Since the luer tip pushes the closing body when it is disengaged from the first engagement groove, the closing body moves to the open circuit position to connect the passage, and the solution in the second medicine chamber flows into the first medicine chamber. When the holder is further pushed into the cap, the rubber stopper of the vial moves until the engaging protrusion of the guide member engages with the second engaging groove of the cap, and all the dissolving agent in the second drug chamber is in the first drug chamber. Therefore, the drug in the first drug chamber and the solution in the second drug chamber can be easily mixed by simply pushing the holder into the cap in order. When the cap is removed in this state, the luer tip is in a protruding state, so that an injection needle of any kind can be attached to the luer tip.

[0010]

Embodiments of the present invention will now be described with reference to the drawings. FIG. 1 is a vertical cross-sectional view of a two-component mixed drug prefilling syringe A which is an embodiment of the present invention. As shown in FIG. 1, this two-component mixed drug prefilling syringe A includes a vial 1, a communicating needle 2, a syringe 3, a cap 4, and a guide member 5.
And a holder 6.

The vial 1 has a cylindrical shape with a bottom and one end is open.
The open end is closed by a rubber stopper 11 to form a second drug chamber n pre-filled with a solution or liquid drug. The rubber stopper 11 has a passage 12 formed in the axial direction, and the passage 12
A spherical closing body 13 is inserted therein, and when the spherical closing body 13 is pushed in by a luer tip 21 of a communication needle 2 described later,
The spherical closure 13 is configured to be movable from the closed position to the open position.

Here, the closed position means a position where the passage 12 is completely closed by the spherical closing body 13, and the open position means a position where the passage 12 is not completely closed by the spherical closing body 13. That is, the open circuit position is as shown in FIG.
It is a spherical space having a diameter slightly larger than the diameter of the spherical closure 13, and two vertical grooves 14 are formed diametrically outward in order to ensure the formation of the passage 12. In addition,
The number of the vertical grooves 14 can be set freely.

The spherical closing member 13 is preferably made of glass or chemical resistant synthetic resin from the viewpoint of blocking the drug. In the present embodiment, the spherical closing body 13 is inserted into the passage 12 to close the passage 12, but any closing body can be used without particular limitation as long as the passage 12 can be completely closed. However, it may be, for example, the closing body 16 having a sectional shape as shown in FIG.

The communicating needle 2 has a luer tip 21 formed at one end and a piercing needle 22 formed at the other end. That is, the piercing needle 22 is a needle continuously formed in the small hole formed in the lure tip 21, and the piercing needle 22 is continuous with the lure tip 21 and has a diameter larger than that of the lure tip 21 at the bottom. And is surrounded by a tubular member 23 having one end opening.

The syringe 3 is a cylindrical member having a tip closed by a rubber plug 31 capable of being pierced, a rear end opened, and a flange 32 provided on the outer periphery of the rear end. Then, the plunger 34 having the gasket 33 at the tip is inserted from the rear end opening, and the first drug chamber m in which the powder or liquid drug is pre-filled is formed in the syringe 3.

The cap 4 has a bottomed tubular shape and is composed of a main body portion 4a and an extension body portion 4b. The vial 1 is accommodated in the main body portion 4a with the rubber stopper 11 of the vial 1 facing the opening side, and the inner peripheral surface of the extension body portion 4b has the first engaging groove 41 on the opening end side. However, the second engaging groove 42 is formed in the substantially central portion. In addition, as shown in FIG. 3, four ribs 44 are used to hold the vial 1 in the main body portion 4a, but the number of ribs can be set freely. Also,
An O-ring 43 is attached to the inside of the open end of the cap 4.

The guide member 5 comprises a cylindrical portion 5a and an engaging piece 5b. Then, at the tip side portion of the cylindrical portion 5a, the luer tip 21 of the communicating needle 2 is directed toward the vial 1 side, and the piercing needle
The communication needle 2 is held with 22 facing the syringe 3.
That is, the luer tip 21 is made to project from the hole formed in the tip side portion of the cylindrical portion 5a of the guide member 5, and the tubular object 23 that surrounds the piercing needle 22 is opened at the tip side portion of the cylindrical portion 5a. The communication needle 2 is held in a state in which it is fitted inside. Further, the distal end portion of the syringe 3 is slidably accommodated in the opening side portion of the cylindrical portion 5a of the guide member 5. On the other hand, the engagement piece 5b has a first engagement groove 41 and a second engagement groove 41 formed in the cap 4.
Engagement projections 53 are formed which can be engaged with the engagement grooves 42 selectively.

The holder 6 is composed of a main body 6a and an engaging / disengaging piece 6b. The body 6a is the flange 32 of the syringe 3.
And a member for holding the rear end of the plunger 34, and the engaging / disengaging piece 6b.
Displaces the engagement piece 5b of the guide member 5 inward,
This is a member for removing 5b from the first engagement groove 41. Further, as shown in FIGS. 1 and 5, four vertical grooves 61 for bleeding air are formed at substantially equal intervals on the outer peripheral surface of the main body 6a. The number of vertical grooves 61 can be set freely.

Next, a method of assembling the two-component mixed drug prefilling syringe A of the present invention will be described. First, as shown in FIGS. 1 and 3, the vial 1 is accommodated in the main body portion 4a of the cap 4, and the rubber stopper 11 thereof is oriented toward the opening side. The second drug chamber n of the vial 1 is filled with a solution or liquid drug.

Next, the communicating needle 2 is accommodated in the distal end side portion of the guide member 5, and the piercing needle 22 is accommodated toward the syringe 3 side,
The tip of the syringe 3 is slidably accommodated in the opening of the cylindrical portion 5a. At this time, the plunger 34 is inserted into the rear end opening of the syringe 3 to form the first drug chamber m in the syringe 3, and the first drug chamber m is filled with the powder or liquid drug. Next, the syringe 3 in which the guide member 5 is attached to the cap 4 is housed, and as shown in FIGS. 1 and 4, the engagement protrusion 53 formed on the engagement piece 5b of the guide member 5 is attached to the extension body of the cap. The first engaging groove 41 formed on the inner peripheral surface of the portion 4b is engaged. Finally, as shown in FIGS. 1 and 5, the body 6a of the holder 6 holds the flange 32 of the syringe 3 and the rear end of the plunger 34, and the engaging / disengaging piece 6b is attached to the cap 4.
Then, the assembly of the two-component mixed drug prefilling syringe A is completed.

Since the O-ring 43 is attached to the inside of the open end of the cap 4, the inside of the two-component mixture type drug prefilling syringe A assembled by the above method is kept airtight. Become. In the present embodiment, the holder 6 is finally inserted into the cap 4, but the rear end of the flange 32 of the syringe 3 and the plunger 34 is held by the holder 6.
Alternatively, the guide member 5 and the holder 6 may be inserted into the cap 4 together.

Next, a method of mixing a powder or liquid drug and a solution using the two-component mixed drug prefilling syringe A of this embodiment will be described. First, as shown in FIG. 6, the engagement piece 6b of the holder 6 is engaged with the engagement projection 53 of the guide member 5.
Push the holder 6 into the cap 4 until it approaches.
At this time, the flange 32 of the syringe 3 is the main body of the holder 6.
Since it is held by 6a, the syringe 3 moves in the same direction as the holder 6 (direction of arrow x in FIG. 6). Therefore,
The rubber stopper 31 that closes the tip of the syringe 3 causes the communication needle 2 to
The rubber plug 31 is inserted into the tubular object 23 having one end opening surrounding the piercing needle 22 and the rubber plug 31 is pierced by the piercing needle 22.

Further, when the holder 6 is pushed into the cap 4, the engaging / disengaging piece 6b of the holder 6 is engaged with the engaging piece of the guide member 5.
In order to bias 5b inward, the engagement protrusion 53 of the guide member 5 that was engaged with the first engagement groove 41 formed in the cap 4 is disengaged from the first engagement groove, and the engagement of the guide member 5 is reduced. The joint piece 5b becomes slidable inside the extension body portion 4b of the cap 4. In the present embodiment, the engaging / disengaging piece 6b of the holder 6 is formed with a downward slope toward the inside from the end, and the downward slope is used to push the end of the engaging piece 5b of the guide member 5 to engage the engaging piece. Although the 5b is moved inward, any method can be used without limitation as long as the engaging piece 5b can be moved inward.

Next, as shown in FIG. 7, when the holder 6 is further pushed into the cap 4, the luer tip 21 of the communicating needle 2 is fitted to the inlet side of the passage 12 of the vial 1 (open end side of the vial 1). Since it is inserted and advances in the passage 12, the tip of the luer tip 21 pushes the spherical closing body 13, and the spherical closing body 13 moves to the open position. Therefore, the second in vial 1
Since the drug chamber n and the first drug chamber m in the syringe 3 are in communication with each other via the communication needle 2, the dissolved or liquid drug prefilled in the second drug chamber n is the first drug. Flows into the room m,
Mixing with the powder or liquid drug pre-filled in the first drug chamber m is started.

At this time, since the inside of the cap 4 is kept airtight, the medicine in the first drug chamber m and the solution in the second drug chamber n are mixed in an airtight state. On the other hand, the air compressed by the cap 4 by pushing the holder 6 into the cap 4 is exposed to the outside through the vertical groove 61 from the time when the end of the vertical groove 61 of the holder 6 passes the O-ring 43 mounting position of the cap 4. Since it is released, it is possible to smoothly push the holder 6 into the cap 4 thereafter.

Next, as shown in FIG. 8, the guide member 5
When the holder 3 is pushed into the cap 4 until the engaging projection 53 of the above is engaged with the second engaging groove 42 formed inside the cap 4, the guide member 5 pushes down the rubber plug 11, so that the rubber plug 11 It itself slides in the vial 1, reaches the bottom of the second drug chamber n, and all the dissolved or liquid drug filled in the second drug chamber n enters the first drug chamber m in the syringe 3. It will flow in.

Finally, as shown in FIG. 9, the cap 4 in which the vial 1 and the guide member 5 are engaged is removed from the holder 6 holding the syringe 3 having the communication needle 2 attached to the tip thereof. Since the engagement projection 53 of the guide member 5 is engaged with the second engagement groove 42 of the cap 4 as described above, the cap 4 can be easily and surely removed from the holder 6. Then, in order to actually use it as a syringe, as shown in FIG. 10, the injection needle S may be attached to the luer tip 21 of the communication needle 2, and the holder 6 may be removed.

As described above, the use of the two-component mixed type drug prefilling syringe A of this embodiment facilitates the assembling, and at the same time, separates the powder or liquid drug and the solution into the first chamber m. Since the second drug chamber n can be pre-filled, it is possible to sterilize the solution after filling the vial with the solution. Moreover, since the powder or liquid drug and the solution are mixed in an airtight state, the two components can be mixed aseptically. Furthermore, since the injection needle S is used by being attached to the luer tip 21, the injection needle S can be freely selected and used, and the syringe at the time of use has substantially the same form as that used normally. Easy to handle.

[0029]

In the two-component mixed type drug prefilling syringe of the present invention, the first drug chamber prefilled with the drug and the second drug chamber prefilled with the solution can be easily assembled separately and independently. The efficiency of the assembling work can be improved, and the solution after filling the vial can be finally sterilized. Moreover, since the mixing is performed in an airtight state, the two components can be mixed aseptically. Furthermore, since the injection needle can be attached to the lure tip, the injection needle and the atomizer that are freely selected can be used, and the syringe can be easily handled because the form of the syringe at the time of administration is compact.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view of a two-component mixed drug prefilling syringe according to an embodiment of the present invention.

FIG. 2 is a cross-sectional view of another embodiment of a closure body inserted into a rubber stopper passage of a vial.

FIG. 3 is a sectional view taken along line III-III in FIG.

4 is a sectional view taken along line IV-IV in FIG.

5 is a sectional view taken along line VV in FIG.

FIG. 6 is a cross-sectional view illustrating a state after puncturing on the syringe side.

FIG. 7 is a cross-sectional view for explaining a state after piercing the vial side.

FIG. 8 is a sectional view for explaining a state after mixing two components.

FIG. 9 is a sectional view illustrating a state when the cap is removed from the holder.

FIG. 10 is a sectional view illustrating a state at the time of completion of preparation for administration.

FIG. 11 is a vertical cross-sectional view of a drug prefilling syringe according to Conventional Example I.

FIG. 12 is a vertical sectional view (A) of a drug prefilling syringe according to Conventional Example II and a sectional view (B) for explaining a state when two components are mixed.

[Explanation of symbols]

A Two-component mixed type drug pre-filling syringe m First drug chamber n Second drug chamber 1 Vial 2 Communication needle 3 Syringe 4 Cap 4a Main body part 4b Extension body part 5 Guide member 5a Cylindrical part 5b Engaging piece 6 Holder 6a Main part 6b Engaging piece 11 Rubber stopper 12 Passage 13 Closing body 21 Luer tip 22 Penetration needle 31 Rubber stopper 32 Flange 33 Gasket 34 Plunger 41 First engaging groove 42 Second engaging groove 53 Engaging projection

Claims (1)

[Claims] 1. A vial having a bottomed tubular shape, one end of which is opened, and the opening end of which is closed by a rubber stopper, and a communication needle having a luer tip formed at one end and a piercing needle formed at the other end. , A cylindrical member whose tip is closed with a pierceable rubber stopper,
A syringe in which a rear end is open and a flange is provided on the outer periphery of the rear end, and a plunger provided with a gasket is inserted from the rear end opening, and a bottomed tubular main body part and extension body part The main body body holds and holds the vial, and the rubber stopper of the vial is directed toward the opening side. The inner peripheral surface of the extension body has a first engagement groove on the opening end side. It consists of a cap having a second engaging groove formed in the central part, a cylindrical portion and an engaging piece, and the communicating needle is provided at the distal end side of the cylindrical portion, and the luer tip of the communicating needle is directed to the vial side. Is held toward the syringe side, and the distal end portion of the syringe is slidably accommodated in the opening side portion of the cylindrical portion, and the first and second engaging grooves of the cap are accommodated in the engaging piece. A guide member having engaging projections that selectively engage with each other, and a holder including a main body and an engaging / disengaging piece. The holder main body is a member that holds the flange of the syringe and the rear end of the plunger, and the engagement / disengagement piece biases the engagement piece of the guide member inward to make the first engagement. It is a member that disengages from the groove, the rubber stopper of the vial has an axial passage formed therein and the closing body is inserted, and when the closing body is pushed by the luer tip of the communicating needle, the closing position is changed from the closed position. The second drug, which is to be moved to the open circuit position, is the first drug chamber in which the syringe is pre-filled with a powder or liquid drug, and the vial is with a second drug pre-filled with a solution or liquid drug. A two-component mixed drug prefilled syringe characterized by being a chamber.