WO2012117622A1 - Prefilled syringe and manufacturing method for prefilled syringe - Google Patents

Abstract

In order to make it possible to seal a medicine in a storage container and cause the storage container and a needle tube to communicate with each other without the occurrence of coring and the deformation of the needle point of the needle tube, a prefilled syringe (1) is provided with a barrel (2), a needle tube (3), a needle hub (4), and a lid member (6). The lid member (6) is configured to make a transition between a first state in which a discharge hole (12a) of a discharge part (12) is closed, and a second state in which a through-hole (6a) provided in the lid member (6), the needle tube (3), and the discharge hole (12a) of the discharge part (12) communicate to thereby form a flow path through which a medicine (M) passes, by the rotation of the needle hub (4).

Description

Prefilled syringe and method for producing prefilled syringe

The present invention relates to a prefilled syringe in which a chemical solution is stored in advance in a syringe that is a storage container, and a method for manufacturing the prefilled syringe.

In recent years, a prefilled syringe in which a medical solution is preliminarily filled in a syringe which is a storage container has been widely used (Patent Document 1). In the prefilled syringe described in Patent Document 1, a double-ended needle held by a needle hub is attached to an outer cylinder prefilled with a medicine. The tip of the double-ended needle that is inserted into the outer cylinder is covered with a rubber cap. Thereby, the medicine filled in the outer cylinder is prevented from leaking. When used, the needle tip of the double-ended needle passes through the rubber cap, so that the inside of the outer cylinder communicates with the outside of the outer cylinder by the double-ended needle.

Further, in another conventional example, a rubber material is provided in a cap attached to the prefilled syringe. When this cap is attached to the prefilled syringe, the needle tip punctures the rubber material in the cap. This prevents the medicine filled in the outer cylinder from leaking out before use.

A conventional prefilled syringe having a needle tube will be described with reference to FIG. FIG. 15A is a cross-sectional view showing a conventional prefilled syringe.
As shown in FIG. 15A, the prefilled syringe 101 has an outer cylinder 102 that is a storage container for storing the medicine M, a needle tube 103 of a double-ended needle, a needle hub 104, and a pusher (not shown). ing. The outer cylinder 102 is formed in a substantially cylindrical shape with both ends opened. A rubber material 105 is attached to the distal end portion of the outer cylinder 102. The rubber material 105 is formed in a substantially disk shape. The rubber material 105 seals the opening on the distal end side of the outer cylinder 102. A pusher (not shown) is inserted into the other end portion of the outer cylinder 102 in the axial direction.

A needle tube 103 having a double-ended needle is fixed to one end of the needle hub 104 in the axial direction. A first needle tip 103 a on one side in the axial direction of the needle tube 103 protrudes from one end of the needle hub 104. The second needle tip 103 b on the other side in the axial direction of the needle tube 103 protrudes from the other end of the needle hub 104. The needle hub 104 is inserted with the outer cylinder 102 from the other side in the axial direction. When the outer cylinder 102 is inserted into the needle hub 104, the second needle tip 103 b of the needle tube 103 penetrates the rubber material 105. Thereby, the inside of the outer cylinder 102 and the outer side of the outer cylinder 102 are communicated by the needle tube 103.

In such a prefilled syringe, it is not necessary to suck the chemical solution from the vial bottle into the syringe at the time of administration of the chemical solution, so that the time required for administration can be shortened and the waste of the chemical solution can be reduced.

FIG. 15B is a cross-sectional view illustrating another conventional prefilled syringe.
As shown in FIG. 15B, the prefilled syringe 201 includes an outer cylinder 202 that is a storage container for storing the medicine M, a needle tube 203, a cap 204, and a pusher (not shown). The outer cylinder 202 is formed in a substantially cylindrical shape with both ends opened. A needle tube 203 is fixed to one end of the outer cylinder 202 in the axial direction. A pusher (not shown) is inserted into the other end portion of the outer cylinder 202 in the axial direction.

A cap 204 is detachably attached so as to cover the needle tip of the needle tube 203 and one end of the outer cylinder 202. The cap 204 is formed in a hollow substantially truncated cone shape. Inside the cap 204, a rubber material 205 into which the needle tip of the needle tube 203 is punctured is provided. And by puncturing the needle tip of the needle tube 203 into the rubber material 205 provided in the cap 204, the medicine M filled in the outer cylinder 202 is prevented from leaking from the needle tip of the needle tube 203 in the state before use. Yes.

JP-A-8-117334

However, in the prefilled syringe described in Patent Document 1, in order to insert one side of the double-ended needle into the syringe and connect the syringe and the double-ended needle, the tip of the double-ended needle is attached to a rubber cap that covers one side of the double-ended needle. Needed to puncture. For this reason, there is a possibility that so-called coring, in which the rubber cap is scraped off by the tip of the double-ended needle, may occur.

Further, in the prefilled syringe 201 shown in FIG. 15B, the drug in the outer cylinder 202 is sealed by puncturing the needle 205 of the needle tube 203 into the rubber material 205 provided on the cap 204. As a result, when the needle tip of the needle tube 203 is punctured into the rubber member 205, there is a problem that coring occurs or the needle tip of the needle tube is deformed and hurt by the rubber member 205.

The object of the present invention is to allow the medicine to be sealed in the storage container without causing the coring or the needle tip of the needle tube to be deformed in consideration of the above-mentioned problems. It is providing the prefilled syringe which can be connected, and the manufacturing method of a prefilled syringe.

In order to solve the above-described problems and achieve the object of the present invention, a prefilled syringe of the present invention includes a storage container provided with a cylindrical discharge portion having a discharge hole for discharging a drug while storing the drug, and a living body. And a needle tube having a needle tip that can be punctured. And a needle hub having a holding portion for holding the proximal end of the needle tube and an insertion portion into which the discharge portion is inserted, the needle hub being rotatable about the discharge portion of the storage container, and a discharge hole of the discharge portion. It has a through hole that allows the needle tube to communicate with it, and is placed in liquid-tight contact with the distal end surface of the discharge portion in a space formed by the distal end surface of the discharge portion and the insertion portion of the needle hub, and is fixed to the needle hub. And a lid member made of an elastic body.

The discharge hole of the discharge part is provided so as to be offset from the axial center of the discharge part to the circumferential side in the radial direction. The lid member can be rotated together with the needle hub, and the first state that closes the discharge hole of the discharge portion communicates with the through hole provided in the cover member, the needle tube, and the discharge hole of the discharge portion. It is configured to be able to transition between the second state in which the flow path is formed.

Moreover, the manufacturing method of the prefilled syringe of this invention includes the process shown to the following (1) to (7).
(1) A step of fixing a needle tube having a needle tip that can puncture a living body to a needle hub.
(2) The process of fixing the cover member which consists of an elastic body to the needle hub to which the needle tube was fixed.
(3) A needle hub to which the needle tube and the lid member are fixed is mounted on the storage container, and the through hole provided in the lid member, the needle tube and the discharge hole of the discharge portion are communicated, and the needle tube and the lid member are fixed. The process of attaching a cap to the hub.
(4) A step of sterilizing the storage container filled with the medicine.
(5) A step of rotating the needle hub about the axis of the discharge part and sealing the discharge hole of the discharge part by the lid member. (6) A step of aseptically transporting the injection device that has undergone the sterilization process into the isolator device.
(7) A step of filling the container in which the needle hub is fixed with a medicine in an aseptic environment.

According to the prefilled syringe of the present invention, there is no need to puncture the needle tip of the needle tube into a sealing member such as a rubber cap when the needle tube communicates with the storage container, so that coring occurs or the needle tip is deformed. And can be prevented from hurting.

It is sectional drawing which shows the 1st Embodiment of the prefilled syringe of this invention. It is sectional drawing which shows the state at the time of communication in the 1st Embodiment of the prefilled syringe of this invention. FIG. 3 is a cross-sectional view showing the alignment mechanism according to the first embodiment of the prefilled syringe of the present invention. FIG. 3 (A) is a cross-sectional view taken along the line KK shown in FIG. ) Is a cross-sectional view taken along line LL shown in FIG. It is a flowchart in the embodiment of the manufacturing method of the prefilled syringe of this invention. It is sectional drawing which shows the 2nd Example of the prefilled syringe of this invention. It is sectional drawing which expands and shows the principal part of 2nd Embodiment of the prefilled syringe of this invention. It is sectional drawing which shows the state at the time of the communication in the 2nd Example of the prefilled syringe of this invention. It is sectional drawing which shows the 3rd Embodiment of the prefilled syringe of this invention. It is sectional drawing which shows the state at the time of communication in the 3rd Embodiment of the prefilled syringe of this invention. It is a top view which shows the support member in the 3rd Embodiment of the prefilled syringe of this invention. It is sectional drawing which shows the 4th example of embodiment of the prefilled syringe of this invention. It is sectional drawing which shows the state at the time of the communication in the 4th Embodiment of the prefilled syringe of this invention. FIG. 13A is a cross-sectional view showing a rotation mechanism according to a fourth embodiment of the prefilled syringe of the present invention. FIG. 13A is a cross-sectional view taken along the line WW shown in FIG. 11, and FIG. FIG. 13 is a cross-sectional view taken along line YY shown in FIG. FIG. 14A is a cross-sectional view showing an attachment / detachment mechanism according to a fourth embodiment of the prefilled syringe of the present invention. FIG. 14A is a cross-sectional view taken along line XX shown in FIG. 11, and FIG. FIG. 13 is a cross-sectional view taken along line ZZ shown in FIG. It is sectional drawing which shows the conventional prefilled syringe with a needle | hook.

Embodiments of the prefilled syringe and the prefilled syringe manufacturing method of the present invention will be described below with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure. The present invention is not limited to the following form.
The description will be given in the following order.
1. 1. First Embodiment 1-1. Configuration example of prefilled syringe 1-2. Method of using prefilled syringe 1-3. 1. Manufacturing method of prefilled syringe Second embodiment example 3. FIG. 3. Third embodiment example Fourth embodiment

<1. First Embodiment>
1-1. Example of prefilled syringe configuration [Prefilled syringe]
First, a first embodiment of the prefilled syringe of the present invention (hereinafter referred to as “this example”) will be described with reference to FIGS.
FIG. 1 is a sectional view showing a first state of the lid member in the prefilled syringe of this example, and FIG. 2 is a sectional view showing a second state of the lid member in the prefilled syringe of this example. 3A is a cross-sectional view taken along the line KK shown in FIG. 1, and FIG. 3B is a cross-sectional view taken along the line LL shown in FIG.

In the prefilled syringe 1 of this example, a medicine to be administered to a living body is stored in advance. As shown in FIG. 1, the prefilled syringe 1 includes an outer tube 2 that stores the medicine M, a hollow needle tube 3 having a needle hole 3a, a needle hub 4 that holds the needle tube 3, a pusher (not shown), And a lid member 6.

The drug M stored in advance in the prefilled syringe 1 may be any drug that is normally used as an injection. For example, protein medical products such as antibodies, peptide medical products such as hormones, nucleic acid medical products, Cellular medicines, blood products, vaccines to prevent various infectious diseases, anticancer drugs, narcotic drugs, narcotics, antibiotics, steroids, proteolytic enzyme inhibitors, heparin, glucose injections such as glucose, sodium chloride and lactic acid Examples include electrolyte correction injection solutions such as potassium, vitamins, fat emulsions, contrast agents, and stimulants.

[Outer cylinder]
The outer cylinder 2 will be described.
The outer cylinder 2 showing a specific example of the storage container is formed in a substantially cylindrical shape, and both ends in the axial direction thereof are open. The outer cylinder 2 includes a substantially cylindrical storage portion 11 that stores the medicine M and a substantially cylindrical discharge portion 12 to which the needle hub 4 is attached.

The container 11 is filled with the medicine M, and a pusher (not shown) is inserted on the other end side of the outer cylinder 2 in the axial direction. The discharge unit 12 is provided continuously from one end of the storage unit 11 in the axial direction. The diameter of the discharge part 12 is set smaller than the diameter of the storage part 11. In the discharge part 12, a discharge hole 12a for discharging the medicine M is formed. The discharge hole 12a is provided at a position offset from the axial center of the discharge portion 12 to the circumferential side in the radial direction, and communicates with the storage portion 11 filled with the medicine M.

Further, a protrusion 16 and two lock portions 14b (see FIG. 3A) are provided on the side surface of the discharge portion 12. The protrusion 16 is continuously provided on the outer peripheral surface of the discharge unit 12 along the circumferential direction. The protrusion 16 is formed to protrude radially outward from the outer peripheral surface of the discharge portion 12 and engages with a recess 19 provided on the inner wall of the needle hub 4 described later.

As shown in FIG. 3A, the two lock portions 14b are provided in the circumferential direction of the discharge portion 12 at a predetermined interval. Further, the lock portion 14 b protrudes outward from the side wall of the discharge portion 12.

Examples of the material of the outer cylinder 2 include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, and acrylonitrile-butadiene-styrene copolymer. And various resins such as polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12). Among them, it is preferable to use a resin such as polypropylene, cyclic polyolefin, polyester, or poly- (4-methylpentene-1) in terms of easy molding. Moreover, it is preferable that the material of the outer cylinder 2 is substantially transparent in order to ensure internal visibility.

In addition, although the example which formed the shape of the accommodating part 11 of the outer cylinder 2 in the substantially cylindrical shape was demonstrated in this example, even if the shape of the accommodating part 11 of the outer cylinder 2 is a hollow square column shape or a hexagonal column shape, Good. As the storage unit 11, for example, a storage unit that stores a medicine using a flexible sheet may be formed in a bag shape. In addition, when forming a storage part in a bag shape, a pusher can be omitted.

[Needle tube]
Next, the needle tube 3 will be described.
As an example of the needle tube 3, one having a size of 10 gauge (outer diameter of about 3.4 mm) to 36 gauge (outer diameter of about 0.1 mm) can be used.

Examples of the material of the needle tube 3 include stainless steel, but are not limited thereto, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used. As the needle tube 3, not only a straight needle but also a double-ended needle or a tapered needle at least partially tapered can be used. As the tapered needle, the proximal end portion has a thicker outer diameter than the needle distal end portion, and the intermediate portion may have a tapered structure. Further, the cross-sectional shape of the needle tube 3 may be not only a circle but also a polygon such as a triangle.

[Needle hub]
Next, the needle hub 4 will be described.
The needle hub 4 has a shape in which a cylinder is connected to the bottom surface of the cone along the axial direction, and one end of the needle hub 4 is open. The needle hub 4 has a holding portion 17 that holds the proximal end of the needle tube 3 and an insertion portion 18 into which the discharge portion 12 of the outer cylinder 2 is inserted. One end of the needle hub 4 in the axial direction is a holding portion 17, and the open end portion on the other side in the axial direction of the needle hub 4 is an insertion portion 18.

The holding part 17 is formed with a fixing hole 17a penetrating along the axial direction and to which the needle tube 3 is attached. The needle tube 3 is fixed to the fixing hole 17a, and the needle tip of the needle tube 3 protrudes from one side of the holding portion 17 in the axial direction. As a method for fixing the needle tube, for example, there are a fixing method by high-frequency welding, adhesion with an adhesive, insert molding, or the like.

An inner flange portion 17b is provided at the end of the fixed hole 17a on the insertion portion 18 side. Since the proximal end portion of the needle tube 3 on the side opposite to the needle tip of the needle tube 3 abuts on the inner flange portion 17b, it is possible to prevent the needle tube 3 from falling off to the insertion portion 18 side.

The insertion part 18 is formed with an insertion hole 18a and a step part 18c into which the discharge part 12 of the outer cylinder 2 is inserted. The inner diameter of the insertion hole 18 a is set to a size corresponding to the outer diameter of the discharge part 12. Moreover, the recessed part 19 and the groove part 21 are formed in the inner wall of the insertion hole 18a.

The recess 19 is set to a size corresponding to the protrusion 16 of the discharge part 12. The recess 19 engages with the protrusion 16 of the discharge unit 12. This restricts the movement of the needle hub 4 in the axial direction and prevents the needle hub 4 from falling off the outer cylinder 2. In this example, the example in which the restricting structure is configured by the protrusion 16 and the recess 19 has been described, but the present invention is not limited to this. For example, it is good also as a structure which provides a recessed part in the discharge part 12, provides an inner flange part in the needle hub 4, and a recessed part and an inner flange part engage.

The groove 21 is provided on one side in the axial direction of the insertion hole 18a. The groove 21 is formed to be recessed from the insertion hole 18a toward the outer wall side from the inner wall side of the needle hub 4. Further, the groove portion 21 is set to a size corresponding to a fixing portion 6b of the lid member 6 described later, and engages with the fixing portion 6b.

The step portion 18 c of the insertion portion 18 is provided on the holding portion 17 side of the insertion portion 18. The stepped portion 18c has a facing surface 18d facing the one end surface 6c on the holding portion 17 side of the lid member 6 described later. By providing the step portion 18 c, a step surface 18 b is formed at one end of the insertion portion 18. The step surface 18b is recessed to one side in the axial direction of the insertion portion 18 from the facing surface 18d. An inflow port 20 is provided on the step surface 18b.

As shown in FIG. 3A, the needle hub 4 has a convex portion 14a. The convex portion 14 a is disposed in the insertion hole 18 a of the insertion portion 18. The convex portion 14 a is provided so as to protrude from the inner wall of the insertion hole 18 a toward the center of the needle hub 4 in the radial direction.

As the material of the needle hub 4, polycarbonate, polypropylene, polyethylene or the like can be used, and various resins of the same material as the outer cylinder 2 can be exemplified.

[Cover member]
Next, the lid member 6 will be described.
The lid member 6 is formed in a substantially cylindrical shape. A through hole 6 a is formed in the lid member 6 along the axial direction thereof, and a fixing portion 6 b is provided on a side surface portion of the lid member 6.
The through-hole 6a is provided continuously so as to connect the one end surface 6c of the lid member 6 on the holding portion 17 side of the needle hub 4 and the other end surface 6d of the lid member 6 on the discharge portion 12 side. The through hole 6 a is disposed at a position shifted from the axial center of the lid member 6 to the circumferential side in the radial direction. Further, as shown in FIG. 3B, the opening on the discharge portion 12 side in the through hole 6a is provided at a position that communicates with the discharge hole 12a when it is regulated by an alignment mechanism 14 described later. .

As shown in FIG. 1, the fixing portion 6 b is provided so as to protrude radially outward from the side surface portion of the lid member 6. The fixing portion 6 b meshes with the groove portion 21 of the needle hub 4, and the lid member 6 is fixed to the needle hub 4. By engaging the fixing portion 6 b and the groove portion 21, the lid member 6 can be prevented from rotating with respect to the needle hub 4.
In this example, the fixed portion 6b is formed in a convex shape, and the groove portion 21 is formed in a concave shape. However, a concave groove portion is formed in the fixed portion 6b, and a convex protrusion is provided instead of the groove portion 21. Thus, the lid member 6 may be fixed to the needle hub 4.

In this example, the lid member 6 is provided with the fixing portion 6b. However, the present invention is not limited to this. The lid member 6 and the needle hub 4 may be fixed so as to be integrated, and may be bonded with an adhesive, for example.

The diameter of the lid member 6 is set equal to or slightly larger than the diameter of the insertion hole 18a. For this reason, the side surface of the cover member 6 and the inner wall of the insertion hole 18a abut. Further, the peripheral edge of the end surface 6 c of the lid member 6 and the facing surface 18 d of the needle hub 4 come into contact with each other. The lid member 6 is disposed in a space formed by the insertion portion 18 of the needle hub 4 and the distal end surface 12b of the discharge portion 12. At this time, a space is formed between the one end surface 6c of the lid member 6 and the step surface 18b of the needle hub 4 facing the one end surface 6c, and the space becomes an inflow path 26 through which the medicine M flows. The inflow passage 26 communicates with the opening on the holding portion 17 side in the through hole 6a. Further, the inflow path 26 communicates with the inflow port 20 of the needle hub 4, and the medicine M flows from the inflow path 26 to the inflow port 20.

The lid member 6 is in liquid-tight contact with the distal end surface 12b of the discharge portion 12, and closes the discharge hole 12a. Thereby, in the state before using the prefilled syringe 1, it can prevent that the chemical | medical agent M with which the outer cylinder 2 was filled leaks from the discharge hole 12a. The state of the lid member 6 at this time is referred to as a first state.

The material of the lid member 6 is not particularly limited, but is preferably made of an elastic material in order to improve liquid tightness with the outer cylinder 2. For example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, various thermoplastic elastomers such as polyurethane, polyester, polyamide, olefin, and styrene, or Elastic materials such as a mixture thereof can be used.

[Positioning mechanism]
An alignment mechanism 14 is configured by the convex portion 14 a provided on the needle hub 4 and the lock portion 14 b provided on the discharge portion 12 of the outer cylinder 2.
As shown in FIG. 3A, when the convex portion 14a of the alignment mechanism 14 is located away from the lock portion 14b, the lid member 6 is in a first state in which the discharge hole 12a is blocked (see FIG. 1). ).
Further, as shown in FIG. 3B, when the convex portion 14a of the alignment mechanism 14 enters between the two lock portions 14b, the positions of the through hole 6a and the discharge hole 12a of the lid member 6 are overlapped and penetrated. It will be in the 2nd state which the hole 6a and the discharge hole 12a connected (refer FIG. 2).

In this example, in order to align the discharge hole 12a and the through hole 6a, the alignment mechanism 14 is configured by the convex portion 14a of the needle hub 4 and the two lock portions 14b of the discharge portion 12. However, the present invention is not limited to this. It is not something. For example, the alignment mechanism may be configured to mark the needle hub 4 and the outer cylinder 2.

Further, when the needle hub 4 is rotated relative to the outer cylinder 2, the through hole 6 a and the discharge hole 12 a are aligned even if the movement of the convex portion 14 a of the needle hub 4 is restricted. be able to. For example, the convex portion 14a is an inner flange that extends along the circumferential direction of the needle hub 4 with a predetermined length, and the lock portion 14b is an outer flange that extends along the circumferential direction of the discharge portion 12 with a predetermined length. And When the needle hub 4 is rotated with respect to the outer cylinder 2 and the lid member 6 is changed from the first state to the second state, the convex portion 14a does not get over the lock portion 14b due to the rotation in the same direction. The configuration is as follows. Accordingly, it is possible to restrict further rotation after the position of the discharge hole 12a and the position of the through hole 6a overlap.

1-2. Next, a method for using the prefilled syringe 1 of this example will be described with reference to FIGS.

First, the state before using the prefilled syringe 1 will be described. As shown in FIG. 1, in the first state before using the prefilled syringe 1, the lid member 6 is in liquid-tight contact with the distal end surface 12 b of the discharge part 12 and closes the discharge hole 12 a of the discharge part 12. Yes. In this first state, as shown in FIG. 3 (A), the convex portion 14a provided on the needle hub 4 is not located between the two lock portions 14b provided on the discharge portion 12, but is separated from the place. Located in.

That is, in this first state, since the discharge hole 12a is blocked by the lid member 6, it is possible to prevent the medicine M stored in the storage unit 11 from leaking. As a result, unlike the conventional prefilled syringes 101 and 201 shown in FIGS. 15 (A) and 15 (B), the needle tip of the needle tube 3 is not punctured into a sealing member such as a rubber material, thereby causing coring. Or the needle tip of the needle tube 3 can be prevented from being damaged.

Next, the operation when the prefilled syringe 1 is used will be described. When using the prefilled syringe 1, first, the needle hub 4 is rotated relatively around the axis of the discharge portion 12. By this rotation, the lid member 6 fixed to the needle hub 4 also rotates.

As shown in FIG. 3B, the convex portion 14a provided on the inner wall of the insertion portion 18 of the needle hub 4 gets over the lock portion 14b provided on the side surface portion of the discharge portion 12, and the two lock portions 14b The needle hub 4 is rotated until it moves in between. Then, the position of the through hole 6a of the lid member 6 and the position of the discharge hole 12a overlap. As a result, as shown in FIG. 2, the through hole 6a, the discharge hole 12a, and the needle tube 3 communicate with each other, and a second state is formed in which a flow path through which the medicine M filled in the outer cylinder 2 passes is formed. .

When the convex portion 14a gets over the lock portion 14b, a click sound and / or a click feeling is given to the user. This click sound and / or click feeling can inform the user that the through hole 6a of the lid member 6 and the discharge hole 12a of the discharge portion 12 are in communication.

1-3. Method for Manufacturing Prefilled Syringe Next, a method for manufacturing the prefilled syringe 1 of the present example having the above-described configuration will be described with reference to FIGS. 4 (A) to 4 (E).

First, as shown in FIG. 4B, the needle tube 3 and the needle hub 4 are fixed together, and the lid member 6 is fixed to the needle hub 4 to which the needle tube 3 is fixed. Then, the needle hub 4 to which the needle tube 3 and the lid member 6 are fixed is attached to the outer cylinder 2 to constitute the syringe body 23. At this time, the through hole 6a of the lid member 6 and the discharge hole 12a of the discharge portion 12 in the outer cylinder 2 are in communication with each other. In this example, in order to attach the needle hub 4 to the outer cylinder 2, engagement by the protrusion 16 and the recess 19 is used.

Next, as shown in FIG. 4C, the cap 22 shown in FIG. In this example, the cap 22 is attached to the needle hub 4 after the needle hub 4 is attached to the outer cylinder 2, but this is not a limitation. For example, the cap 22 may be attached to the needle hub 4 and then the outer cylinder 2 may be attached to the needle hub 4.

Then, as shown in FIG. 4 (D), the syringe body 23 fitted with the cap 22 is sterilized. For the sterilization process, for example, a sterilization process that generates heat, such as AC (autoclave) sterilization or EOG (ethylene oxide gas) sterilization, is used. Since the discharge hole 12a, the through-hole 6a, the needle hole 3a of the needle tube 3 and the inside of the cap 22 communicate with each other, the cap 22 and the syringe body 23 can be sterilized at a time.

Thereafter, the needle hub 4 of the syringe body 23 that has been sterilized is rotated about the axis of the discharge portion 12, the positional relationship between the through hole 6 a and the discharge hole 12 a is changed to the first state, and the lid member 6. Then, the discharge hole 12a is sealed.
Next, the syringe body 23 that has undergone the sterilization process is aseptically conveyed into the isolator device.

Thereafter, as shown in FIG. 4 (E), the nozzle 24 for discharging the medicine M is inserted into the cylindrical hole 11a of the storage portion 11 of the outer cylinder 2, and the medicine M is injected from the nozzle 24 into the cylindrical hole 11a. Thereby, the medicine M is filled in the tube hole 11 a of the storage portion 11 of the outer tube 2. The step of filling the medicine M is also performed in an isolator device in an aseptic environment. And the gasket which comprises a pusher is plugged in the cylinder hole 11a of the accommodating part 11 of the outer cylinder 2 with which the chemical | medical agent M was filled, and manufacture of the prefilled syringe 1 is completed.

According to the manufacturing method of the prefilled syringe 1 of this example, the needle tube 3, the through hole 6a, and the outer cylinder 2 of the assembled syringe body 23 are communicated to perform sterilization. Thereby, the syringe main body 23 and the cap 22 can be sterilized at a time.

In the method for manufacturing the prefilled syringe 1 according to this example, the cap 22 is attached to the needle hub 4 and then sterilization is performed. However, the present invention is not limited to this process. The cap 22 may be attached to the needle hub 4 after the cap 22 and the syringe body 23 are separately sterilized.

Further, in the sterilization process of the manufacturing method of the prefilled syringe 1 according to this example, sterilization that generates heat such as AC (autoclave) sterilization or EOG (ethylene oxide gas) sterilization is performed, but the present invention is not limited thereto. It is not something. For example, you may perform what is called radiation sterilization which irradiates radiation, such as a gamma ray and an electron radiation.

<2. Second Embodiment>
Next, a second embodiment of the prefilled syringe of the present invention will be described with reference to FIGS.
FIG. 5 is a cross-sectional view showing a first state of the lid member in the prefilled syringe according to the second embodiment. FIG. 6 is an enlarged cross-sectional view showing a main part of the opening / closing mechanism in the prefilled syringe according to the second embodiment. FIG. 7 is a cross-sectional view showing a second state of the lid member in the prefilled syringe according to the second embodiment.

The prefilled syringe 40 according to the second embodiment is different from the prefilled syringe 1 according to the first embodiment in that a support member for reinforcing the lid member is added and the support member is fixed to the needle hub. This is the point. Therefore, here, the support member and matters related to the support member will be described, the same reference numerals are assigned to the parts common to the prefilled syringe 1, and redundant description will be omitted.

As shown in FIG. 5, the needle hub 44 has a holding portion 45 that holds the proximal end of the needle tube 3 and an insertion portion 46 into which the discharge portion 12 of the outer cylinder 2 is inserted. That is, one side in the axial direction of the needle hub 44 serves as the holding portion 45, and the other side in the axial direction of the needle hub 44 serves as the insertion portion 46.

A stepped portion 46 c is provided on the holding portion 45 side of the insertion portion 46. The stepped portion 46c has a facing surface 46d that faces one end surface 41d on the holding portion 45 side of the support member 41 described later. By providing the stepped portion 46 c, a stepped surface 46 b is formed at one end of the insertion portion 46. The step surface 46b is recessed to one side in the axial direction of the insertion portion 46 from the facing surface 46d. An inflow port 49 is provided on the step surface 46b.

As shown in FIG. 6, a groove 42 and a recess 48 are provided on the inner wall of the insertion hole 46 a of the insertion portion 46. The recess 48 engages with the protrusion 16 of the discharge unit 12. Therefore, the movement of the needle hub 44 in the axial direction is restricted and the needle hub 44 is prevented from falling off the outer cylinder 2. Moreover, the groove part 42 is depressed toward the outer wall side from the inner wall side of the insertion hole 46a, and engages with a fixing part 41b of the support member 41 described later.

The support member 41 is formed in a substantially cylindrical shape. The peripheral edge of the end surface 41 d of the support member 41 is in contact with the facing surface 46 d of the needle hub 44. The support member 41 is disposed so as to face the step surface 46 b of the needle hub 44. Further, the support member 41 is fixed to one surface of the lid member 43 opposite to the axial direction of the lid member 43 with respect to the portion of the lid member 43 that contacts the tip end surface 12b of the discharge portion 12.

In the support member 41, a communication hole 41a is formed along the axial direction of the support member 41, and a fixing portion 41b is provided on a side surface of the support member 41. The diameter of the support member 41 is set to be equal to or slightly larger than the diameter of the lid member 43.

The communication hole 41 a is continuously provided so as to connect the one end surface 41 d on the holding member 45 side of the support member 41 and the other end surface 41 e on the discharge portion 12 side of the support member 41, and has a radius from the axis of the support member 41. It is provided at a position shifted to the circumferential side of the direction. Further, the opening on the discharge portion 12 side in the communication hole 41 a is formed so as to communicate with the through hole 43 a of the lid member 43. The inner diameter of the communication hole 41 a is set to be approximately the same as the inner diameter of the through hole 43 a of the lid member 43.

A fixing protrusion 41c is formed on the other end surface 41e of the support member 41. A fixing groove 43b is formed on one end surface 43c of the lid member 43 on the holding portion 45 side. The support member 41 and the lid member 43 are fixed by engaging the fixing protrusion 41c and the fixing groove 43b. The support member 41 and the lid member 43 constitute an opening / closing mechanism 47. The support member 41 may be provided with a fixing groove, and the lid member 43 may be provided with a fixing protrusion that engages with the fixing groove.

The fixing portion 41b of the support member 41 is provided so as to protrude from the side surface portion of the support member 41 in the radially outward direction. The opening / closing mechanism 47 is fixed to the needle hub 44 by engaging the fixing portion 41 b with the groove portion 42 of the needle hub 44. The opening / closing mechanism 47 is disposed in a space formed by the insertion portion 46 of the needle hub 44 and the distal end surface 12 b of the discharge portion 12. Further, the lid member 43 of the opening / closing mechanism 47 is in liquid-tight contact with the distal end surface 12b of the discharge unit 12.

In the second embodiment, the support member 41 is provided with the fixing portion 41b. However, the present invention is not limited to this. The needle hub 44 may be fixed to the lid member 43 so as to be integrated, that is, the opening / closing mechanism 47 may be fixed to the needle hub 44.

As shown in FIG. 7, when the needle hub 44 is rotated relative to the axis of the discharge portion 12, the opening / closing mechanism 47 fixed to the needle hub 44 is rotated. With this rotation, the positions of the communication hole 41a and the through hole 43a in the opening / closing mechanism 47 move. When the convex portion 14a gets over the lock portion 14b and enters between the two lock portions 14b, the discharge hole 12a, the through hole 43a, the communication hole 41a, and the needle hole 3a of the needle tube 3 are in communication. At this time, the medicine M filled in the storage portion 11 of the prefilled syringe 40 is discharged through the discharge hole 12a, the through hole 43a, the communication hole 41a, the inflow path 26, the inflow port 49, and the needle hole 3a of the needle tube 3.

As the material of the support member 41, polycarbonate, polypropylene, polyethylene or the like can be used, and various resins made of the same material as the outer cylinder 2 can be used.

In the second embodiment, the support member 41 that reinforces the lid member 43 is added. Accordingly, the strength of the lid member 43 can be maintained, and the opening / closing mechanism 47 can be stably rotated.

Other configurations are the same as those of the prefilled syringe 1 according to the above-described first embodiment, and thus description thereof is omitted. Also with the prefilled syringe 40 having such a configuration, the same operations and effects as those of the prefilled syringe 1 according to the above-described first embodiment can be obtained.
<3. Third Embodiment>
Next, a third embodiment of the prefilled syringe of the present invention will be described with reference to FIGS.
FIG. 8 is a cross-sectional view showing a first state of the lid member in the prefilled syringe according to the third embodiment. FIG. 9 is a cross-sectional view showing a second state of the lid member in the prefilled syringe according to the third embodiment. FIG. 10 is a top view of the support member in the prefilled syringe according to the third embodiment.

The prefilled syringe 50 according to the third embodiment differs from the prefilled syringe 40 according to the second embodiment in that an inflow groove is provided on the end surface of the support member on the side of the needle hub. is there. Here, the matters related to the support member and the support member will be described, and the same reference numerals are given to the portions common to the prefilled syringe 40 according to the second embodiment, and the duplicate description will be omitted.

As shown in FIG. 8, the needle hub 54 has a holding portion 55 that holds the proximal end of the needle tube 3, an insertion portion 56 into which the discharge portion 12 of the outer cylinder 2 is inserted, and a recess 58. One side of the needle hub 54 in the axial direction is a holding portion 55, and the other side of the needle hub 54 in the axial direction is an insertion portion 56.

A groove portion 52 and a concave portion 58 are provided on the inner wall of the insertion hole 56a of the insertion portion 56. The recess 58 engages with the protrusion 16 of the discharge unit 12. Therefore, the movement of the needle hub 54 in the axial direction is restricted and the needle hub 54 is prevented from falling off the outer cylinder 2. Moreover, the groove part 52 is depressed toward the outer wall side from the inner wall side of the insertion hole 56a, and engages with a fixing part 51b of the support member 51 described later.

The support member 51 is formed in a substantially cylindrical shape, a communication hole 51 a is formed along the axial direction of the support member 51, and a fixing portion 51 b is provided on a side surface portion of the support member 51. The diameter of the support member 51 is set to the same size as the diameter of the lid member 43.

Further, the support member 51 has a communication hole 51a, a fixing portion 51b, a fixing projection 51c, and an inflow groove 51d. Since the communication hole 51a, the fixing portion 51b, the fixing protrusion 51c, and the fixing groove 43b have the same configuration as the support member 41 and the lid member 43 of the prefilled syringe 40 according to the second embodiment, the description thereof will be given here. Is omitted.

As shown in FIG. 10, the inflow groove 51d is provided continuously from the opening on the holding portion 55 side in the communication hole 51a. In addition, the inflow groove 51 d is formed from the communication hole 51 a toward the radial center of the support member 51. The inflow groove 51d communicates with the communication hole 51a and the through hole 43a, and serves as an inflow path for the medicine M.

The support member 51 and the lid member 43 constitute an opening / closing mechanism 57. The opening / closing mechanism 57 is disposed so as to contact an end surface 51e of the support member 51 on the holding portion 55 side and a facing surface 56b of the insertion hole 56a facing the distal end surface 12b of the discharge portion 12, and is fixed to the needle hub 54. Is done. Further, the lid member 43 of the opening / closing mechanism 57 is in liquid-tight contact with the distal end surface 12b of the discharge unit 12.

An inflow port 59 is provided on the opposing surface 56 b of the needle hub 54. The inflow port 59 communicates with the inflow groove 51d. The facing surface 56 b of the needle hub 54 is a flat surface and is in contact with one end surface 51 e of the support member 51.

When the needle hub 54 is rotated relative to the center of the discharge portion 12, the opening / closing mechanism 57 fixed to the needle hub 54 rotates, and the inflow groove 51d, the communication hole 51a, and the through hole 43a of the opening / closing mechanism 57 are rotated. The position moves. As shown in FIG. 9, when the needle hub 54 is rotated until the opening of the other end face 43d on the discharge portion 12 side of the lid member 43 is aligned with the discharge hole 12a, the discharge hole 12a and the through hole 43a communicate with each other. As a result, the discharge hole 12a, the through hole 43a, the communication hole 51a, the inflow groove 51d, and the needle hole 3a of the needle tube 3 are in communication. At this time, the medicine M filled in the outer cylinder 2 of the prefilled syringe 50 is discharged through the discharge hole 12a, the through hole 43a, the communication hole 51a, the inflow groove 51d, the inflow port 59, and the needle hole 3a of the needle tube 3.

In the third embodiment, the support member 51 is provided with an inflow groove 51d. In addition, the opening / closing mechanism 57 is arranged to be in contact with the opposing surface 56b of the needle hub 54 and the one end surface 51e of the opening / closing mechanism 57 on the support member 51 side. As a result, the dead volume in the syringe is reduced by the amount corresponding to the inflow path 26 as compared with the prefilled syringes 1 and 40 according to the first and second embodiments. Therefore, the amount of the drug M remaining in the syringe can be reduced, and the drug M can be used efficiently.

If the inflow groove 51d is provided in the lid member 43, the lid member 43 may be elastically deformed and the inflow groove may be blocked. Therefore, it is preferable to provide the inflow groove 51d in the support member 51 that is not easily elastically deformed.

Other configurations are the same as those of the prefilled syringes 1 and 40 according to the above-described first and second embodiments, and thus description thereof is omitted. Also with the prefilled syringe 50 having such a configuration, the same operations and effects as the prefilled syringes 1 and 40 according to the first and second embodiments described above can be obtained.

<4. Fourth Embodiment>
Next, a fourth embodiment of the prefilled syringe of the present invention will be described with reference to FIGS.
FIG. 11 is a sectional view showing a fourth embodiment of the prefilled syringe of the present invention. FIG. 12 is a cross-sectional view showing a state during communication in the fourth embodiment of the prefilled syringe of the present invention. 13 is a cross-sectional view showing a rotation mechanism according to a fourth embodiment of the prefilled syringe of the present invention. FIG. 13A is a cross-sectional view taken along the line WW shown in FIG. FIG. 13B is a sectional view taken along line YY shown in FIG. FIG. 14 is a sectional view showing an attaching / detaching mechanism according to a fourth embodiment of the prefilled syringe of the present invention, and FIG. 14 (A) is a sectional view taken along line XX shown in FIG. FIG. 14B is a cross-sectional view taken along the line ZZ shown in FIG.

The difference between the prefilled syringe 60 according to the fourth embodiment and the prefilled syringe 1 according to the first embodiment is that a rotation mechanism and an attachment / detachment mechanism are provided. Here, matters related to the rotation mechanism and the attachment / detachment mechanism will be described, and portions common to the prefilled syringe 1 according to the first embodiment will be denoted by the same reference numerals, and redundant description will be omitted.

As shown in FIG. 11, the needle hub 64 has a holding portion 77 that holds the proximal end of the needle tube 3, and an insertion portion 78 into which the discharge portion 72 of the outer cylinder 62 is inserted. One side of the needle hub 64 in the axial direction is a holding portion 77, and the other side of the needle hub 64 in the axial direction is an insertion portion 78. A cap 80 that covers the needle tip of the needle tube 3 is attached to the outer cylinder 62 and the needle hub 64.

The cap 80 is formed in a cylindrical shape, and one end on the needle tip side of the needle tube 3 in the axial direction of the cap 80 is closed. On the other hand, the other end on the outer cylinder 62 side in the axial direction of the cap 80 is open. The cap 80 is set to a size corresponding to the size of a flange portion 73 described later in order to seal the inside of the cap 80.

Rotating convex portions 81 are provided on the inner side surface of the cap 80. The rotation convex portion 81 is formed to protrude inward in the radial direction of the cap 80. The rotation convex portion 81 is provided so as to come into contact with a rotation projection 79 described later when the cap 80 is rotated. Therefore, the rotation convex portion 81 is set to a size corresponding to the rotation protrusion 79.

As shown in FIG. 13A, two rotating projections 79 are provided on the side surface of the needle hub 64. The rotation protrusion 79 is formed so as to protrude perpendicularly to the axial direction of the needle hub 64 from the side surface portion of the needle hub 64. The height of the rotation protrusion 79 is set to the same height as the rotation protrusion 81 with respect to the axial direction of the needle hub 64. For this reason, when the attached cap 80 is rotated, the rotation convex portion 81 provided on the cap 80 rotates and abuts on the rotation protrusion 79 of the needle hub 64. Further, when the cap 80 is rotated, the rotation protrusion 79 is pressed against the rotation protrusion 81. As a result, the needle hub 64 rotates in conjunction with the rotation of the cap 80 as shown in FIG. By this rotation, as shown in FIG. 12, the positions of the through hole 6a of the lid member 6 and the discharge hole 72a of the discharge part 72 overlap, and the through hole 6a and the discharge hole 72a communicate with each other. The rotation projection 79 and the rotation projection 81 constitute a rotation mechanism.

In the fourth embodiment, the rotation mechanism has a structure in which two rotation protrusions 79 and two rotation protrusions 81 are provided. However, the present invention is not limited to this. For example, one or more rotation protrusions 79 and one or more rotation protrusions 81 may be provided.

As shown in FIG. 14A, a detachable protrusion 82 is provided on the other end of the cap 80. The detachable protrusion 82 is formed so as to protrude from the inner side surface of the cap 80 toward the inner side in the radial direction of the cap 80. The detachable protrusion 82 engages with a flange portion 73 described later of the discharge portion 72. This restricts the movement of the cap 80 in the axial direction and prevents the cap 80 from being detached from the outer cylinder 62.

The flange part 73 is provided in the side part of the discharge part 72. FIG. The flange portion 73 is formed from the side surface portion of the discharge portion 72 toward the outer side in the radial direction. As shown in FIGS. 14A and 14B, the flange 73 engages with the detachable protrusion 82 until the lid member 6 is in the second state. Therefore, the movement of the cap 80 in the axial direction can be restricted, and the cap 80 is prevented from being detached from the outer cylinder 62.

Also, a detachable groove 74 is provided on the outer edge of the flange portion 73. As shown in FIG. 14B, the size of the attaching / detaching groove 74 is set larger than the size of the attaching / detaching protrusion 82 because the attaching / detaching protrusion 82 passes when the cap 80 is attached / detached.

The cap 80 is configured to be attachable / detachable when the attaching / detaching protrusion 82 passes through the attaching / detaching groove 74 when the lid member 6 is in the second state. The attachment / detachment groove 74 and the attachment / detachment protrusion 82 constitute an attachment / detachment mechanism. The user can puncture the injection needle when the lid member 6 is in the second state. As a result, it is possible to prevent the injection needle from being punctured when the lid member 6 is in the first state.

In the fourth embodiment, the detachable protrusion 82 is described as being engaged with the flange portion 73 of the discharge portion 72. However, the present invention is not limited to this. For example, the needle hub 64 may be provided with a flange and the detachable protrusion 82 may be engaged with the needle hub 64.

Other configurations are the same as those of the prefilled syringe 1 according to the above-described first embodiment, and thus description thereof is omitted. Also with the prefilled syringe 60 having such a configuration, the same operations and effects as those of the prefilled syringe 1 according to the first embodiment described above can be obtained.

In the fourth embodiment, the support members 41 and 51 in the second and third embodiments can be added. In that case, the same operations and effects as those of the prefilled syringes 40 and 50 according to the second and third embodiments described above can be obtained.

The present invention is not limited to the embodiment described above and shown in the drawings, and various modifications can be made without departing from the scope of the invention described in the claims.

1, 40, 50, 60 ... Prefilled syringe, 2, 62 ... Outer cylinder (storage container), 3 ... Needle tube, 3a ... Needle hole, 4, 44, 54, 64 ... Needle Hub, 6, 43 ... lid member, 6a, 43a ... through hole, 6b ... fixed part, 6c, 43c ... one end face, 6d, 43d ... other end face, 11 ... storage Part, 11a ... cylinder hole, 12, 72 ... discharge part, 12a, 72a ... discharge hole, 12b ... tip surface, 14 ... positioning mechanism, 14a ... convex part, 14b ... Lock part, 16 ... Projection part, 17, 45, 55, 77 ... Holding part, 17a ... Fixing hole, 17b ... Inner flange part, 18, 46, 56, 78 ... -Insertion part, 18a, 46a, 56a ... insertion hole, 18b, 46b ... step surface, 18c, 46c ... step part, 8d, 46d, 56b ... facing surface, 19, 48, 58 ... recess, 20, 49, 59 ... inlet, 21, 42, 52 ... groove, 22, 80 ... cap, 23 ... Syringe body, 24 ... Nozzle, 26 ... Inflow passage, 41, 51 ... Support member (auxiliary member), 41a, 51a ... Communication hole, 41b, 51b ... Fixing part 41c, 51c... Fixing protrusion, 41d, 51e... One end surface, 41e... Other end surface, 43b. ... Flange part, 74 ... Removable groove, 79 ... Rotary protrusion, 81 ... Rotary convex part, 82 ... Rotary protrusion

Claims (6)

1. A storage container provided with a columnar discharge portion having a discharge hole for discharging the drug while storing the drug;
   A needle tube having a needle tip that can puncture a living body;
   A needle hub that has a holding portion that holds the proximal end of the needle tube, and an insertion portion into which the discharge portion is inserted, and is provided so as to be rotatable around an axis of the discharge portion of the storage container;
   A through-hole through which the discharge hole of the discharge portion and the needle tube communicate with each other, and a liquid tight seal between the tip end surface of the discharge portion and the tip end surface of the discharge portion in a space formed by the insertion portion of the needle hub A lid member fixed to the needle hub and made of an elastic body.
   The discharge hole is provided so as to be offset from the axial center of the discharge portion to the circumferential side in the radial direction,
   By rotating the needle hub and the storage container relatively, the lid member closes the discharge hole of the discharge portion, and the through hole and the needle tube provided in the cover member A prefilled syringe configured to be capable of transitioning between a second state in which a flow path through which the medicine passes is formed through communication with the discharge hole of the discharge unit.
2. A portion of the lid member that contacts the tip end surface of the discharge portion and an auxiliary member that is fixed to the opposite side in the axial direction of the lid member are provided,
   The prefilled syringe according to claim 1, wherein the auxiliary member is provided with a communication hole communicating with the through hole of the lid member.
3. The prefilled syringe according to claim 2, wherein the auxiliary member has a groove serving as an inflow path through which the medicine passes.
4. Covering the needle tip of the needle tube held by the needle hub, further provided with a cap attached to the storage container or the needle hub;
   The needle hub and the cap are provided with a rotation mechanism that rotates the needle hub in conjunction with the rotation of the cap when the cap is rotated relative to the storage container. The prefilled syringe according to claim 1.
5. The prefilled syringe according to claim 4, wherein the storage container or the needle hub is provided with an attachment / detachment mechanism that allows the cap to be attached / detached when the lid member is in the second state. .
6. Fixing a needle tube having a needle tip that can puncture a living body to a needle hub;
   Fixing a lid member made of an elastic body to the needle hub to which the needle tube is fixed;
   The needle hub to which the needle tube and the lid member are fixed is attached to a storage container, and a through hole provided in the lid member is communicated with the needle tube and a discharge hole of the discharge portion, and the needle tube and the lid member are Attaching a cap to the fixed needle hub;
   Sterilizing the storage container filled with the medicine;
   Rotating the needle hub around the axis of the discharge part and sealing the discharge hole of the discharge part by the lid member;
   Aseptically transporting the injection device that has undergone the sterilization process into the isolator device; and
   And a step of filling the storage container to which the needle hub is fixed with the medicine in an aseptic environment.

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