JP2022032701A - Manufacturing method for needle-having syringe and needle-having syringe - Google Patents

Abstract

To provide a manufacturing method for a needle-having syringe and a needle-having syringe that are able to reduce a manufacturing cost.SOLUTION: A manufacturing method for a needle-having syringe includes: a first step of attaching a holder 12 partially covering an outer peripheral surface of a needle tube 11 in an axial direction, to a basal-end 11B side of the needle tube 11 having a needle tip 11A at a leading end thereof; a second step of, while keeping a syringe mold 20, composed of a first mold 21 and a second mold 22 that are brought into contact with each other, open, inserting the leading-end side of the needle tube 11 into a leading-end-side needle tube storage portion 24 provided in the first mold 21 and locking a leading-end 12A of the holder 12 to a leading-end side holder locking portion 24A provided on an inlet side of the leading-end side needle tube storage portion 24; a third step of closing the syringe mold 20 and disposing an axial part of the holder 12 into a cavity 23 of the syringe mold 20; and a fourth step of forming a syringe by filling resin into the cavity 23 of the syringe mold 20.SELECTED DRAWING: Figure 3

Description

The present invention relates to a method for manufacturing a syringe with a needle and a syringe with a needle.

Conventionally, some syringes having a relatively small capacity used for insulin administration or the like have a needle tube directly bonded to a syringe (outer cylinder) without using a needle hub. In such a syringe with a needle, the needle tube is generally bonded to the syringe using an adhesive.

However, when an adhesive is used for joining the needle tube and the syringe, there is a problem that the components of the adhesive may elute or leak into the chemical solution or the like, which may adversely affect the living body to which the chemical solution or the like is administered. In particular, in a prefilled syringe in which a syringe is previously filled with a chemical solution or the like, the adhesive is in contact with the chemical solution or the like for a long period of time, and the amount of the adhesive component eluted or leaked into the chemical solution or the like is large. There was a need for a joining method to replace the agent.

On the other hand, a method has been proposed in which a needle tube is fixed (held) to a mold for injection molding of a syringe to form a syringe integrally with the needle tube, that is, a syringe with a needle is manufactured by insert molding (for example). , Patent Document 1). According to insert molding, since the needle tube and the syringe can be joined without using an adhesive, it is possible to solve the problem of elution or leakage of the adhesive component into a chemical solution or the like.

Japanese Unexamined Patent Publication No. 2018-61856

However, in the method described in Patent Document 1, since the needle tube is fixed to the mold by sandwiching it between two chuck members, the chuck member and the chuck member that can be moved with respect to the mold are moved. There is a problem that the configuration of the mold and its peripheral equipment becomes complicated and the manufacturing cost increases due to the need for a mechanism.

In view of such circumstances, the present invention is intended to provide a method for manufacturing a syringe with a needle and a syringe with a needle capable of reducing the manufacturing cost.

The method for manufacturing a syringe with a needle of the present invention is in contact with the first step of mounting a holder that partially covers the outer peripheral surface of the needle tube in the axial direction on the base end side of the needle tube having a needle tip at the tip. With the syringe mold composed of the first mold and the second mold open, the tip side of the needle tube is inserted into the tip side needle tube accommodating portion provided in the first mold, and the tip side of the needle tube is inserted. The second step of locking the tip of the holder to the holder locking portion of the tip side provided on the inlet side of the needle tube accommodating portion on the tip side, and closing the die for the syringe to partially cover the holder in the axial direction. It is characterized by including a third step of arranging the cavity in the syringe mold and a fourth step of filling the cavity of the syringe mold with a resin to form a syringe.

According to the method for manufacturing a syringe with a needle of the present invention, the needle tube can be fixed to the syringe mold by using the tip portion of the needle tube to which the holder is attached, which is a stepped portion. Syringes with needles can be manufactured by insert molding at low cost without complicating the configuration of the syringe and its peripheral devices or processing the needle tube accommodating portion with high precision.

Further, according to the method for manufacturing a syringe with a needle of the present invention, even a small-diameter needle tube with less pain, which is in increasing demand with the spread of prefilled syringes for self-administration, can be fixed via a holder at low cost. Insert molding is possible. Further, since it is not necessary to directly contact the syringe mold, the chuck member, or the like with the needle tube, it is possible to prevent the needle tube from being scratched or deformed.

Further, in the method for manufacturing a syringe with a needle of the present invention, it is preferable that the base end surface of the holder is brought into contact with the second mold in the third step.

According to this, the needle tube equipped with the holder can be sandwiched between the first mold and the second mold and stably held without complicating the configuration of the syringe mold and its peripheral devices. can. Further, since the locking structure of the base end portion of the holder provided at the tip end portion of the core pin (core) in the second mold can be simplified or omitted, the dead space generated inside the syringe can be simplified or omitted. The volume of (a dent where the tip surface of the gasket does not abut) can be reduced.

Further, in the method for manufacturing a syringe with a needle of the present invention, in the third step, it is preferable to lock the base end portion of the holder to the base end side holder locking portion provided in the second mold.

According to this, the needle tube equipped with the holder is locked to both the first mold and the second mold and stably held without complicating the configuration of the syringe mold and its peripheral devices. Can be done.

Further, in the method for manufacturing a syringe with a needle of the present invention, it is preferable to weld the holder to the needle tube in the first step.

According to this, the holder can be reliably attached to the needle tube as compared with other joining methods such as insert molding, welding or pressure welding.

Further, in the method for manufacturing a syringe with a needle of the present invention, it is preferable to include a preliminary step of forming a rough surface on the outer peripheral surface of the holder before the second step.

According to this, since the contact area with the resin constituting the syringe is increased due to the unevenness of the surface and the anchor effect is generated, the bondability and the bonding strength between the holder and the syringe can be improved.

Further, in the method for manufacturing a syringe with a needle of the present invention, in the first step, a resin is placed in the cavity of the holder mold in a state where a part of the needle tube in the axial direction is arranged in the cavity of the holder mold. It is also preferable to fill the holder to form the holder.

According to this, since the insert molding is performed in two stages, it is possible to reduce the cost as compared with the case where the syringe and the needle tube are insert-molded at one time, and the insert molding is performed for the thinner needle tube. Is possible. Specifically, since the holder is much smaller than the syringe and does not require a complicated shape, the holder mold is smaller and simpler than the syringe mold, and the injection pressure and holding pressure during insert molding are obtained. Molding conditions such as conditions will also be relaxed. Therefore, even a holder mold for directly fixing a thin needle tube can be manufactured with relatively low processing accuracy, and the first-stage insert molding in which only the holder is integrally formed with the needle tube is performed. It will be simple. Then, as described above, by forming the syringe integrally with the needle tube to which the holder is attached, the cost of insert molding in the second stage can be reduced, and a thinner needle tube can be insert-molded together with the syringe. It will be possible.

Further, in the method for manufacturing a syringe with a needle of the present invention, it is preferable to include a preliminary step of forming a rough surface on the outer peripheral surface of the needle tube before the first step.

According to this, since the contact area with the resin constituting the holder is increased due to the unevenness of the surface and the anchor effect is generated, the bondability and the bonding strength between the needle tube and the holder can be improved.

Further, the syringe with a needle of the present invention includes a needle tube having a needle tip at the tip, and a needle tube with a holder which is attached to the base end side of the needle tube and has a holder which partially covers the outer peripheral surface of the needle tube in the axial direction. It comprises a syringe joined to the holder-attached needle tube by insert molding, wherein the holder is characterized in that at least the distal end surface is exposed from the syringe.

According to the syringe with a needle of the present invention, the needle tube can be fixed to the syringe mold by using the tip of the holder which is a stepped portion in the needle tube with a holder. It is not necessary to complicate the configuration of the device or process the needle tube accommodating portion with high precision, and a syringe with a needle can be manufactured by insert molding at low cost.

Further, according to the syringe with a needle of the present invention, even for a small diameter needle tube with less pain, which is in increasing demand with the spread of prefilled syringes for self-administration, insert molding can be performed at low cost by fixing through a holder. It is possible. Further, since it is not necessary to directly contact the syringe mold, the chuck member, or the like with the needle tube, it is possible to prevent the needle tube from being scratched or deformed.

Further, in the syringe with a needle of the present invention, it is preferable that the base end surface of the holder is exposed from the syringe.

According to this, the needle tube equipped with the holder can be sandwiched between the movable side mold and the fixed side mold and stably held without complicating the configuration of the syringe mold and its peripheral equipment. can. Further, for example, since the locking structure of the base end portion of the holder provided at the tip end portion of the core pin (core) in the fixed side mold can be simplified or omitted, the dead generated inside the syringe can be simplified or omitted. The volume of space can be reduced.

According to the method for manufacturing a syringe with a needle and the syringe with a needle of the present invention, it is possible to obtain an excellent effect that the manufacturing cost can be reduced.

A is a front view of a syringe with a needle according to an embodiment of the present invention. B is a sectional view taken along line II in FIG. 1A. A and B are schematic views showing a method of manufacturing a syringe with a needle. It is a schematic diagram which showed the manufacturing method of the syringe with a needle. It is a schematic diagram which showed the manufacturing method of the syringe with a needle. It is a schematic diagram which showed the manufacturing method of the syringe with a needle. A to C are schematic views showing a method of mounting a holder on a needle tube by insert molding. It is the schematic which showed the modification of the manufacturing method of the syringe with a needle. It is the schematic which showed the modification of the manufacturing method of the syringe with a needle.

Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. First, the configuration of the syringe 1 with a needle will be described. 1A is a front view of a syringe 1 with a needle according to an embodiment of the present invention, and FIG. 1B is a sectional view taken along line II in FIG. 1A.

The syringe 1 with a needle is used to puncture the tip of a needle from the surface of the skin and inject a drug solution or the like into a living body. As shown in FIGS. 1A and 1B, the syringe 1 with a needle is attached to the needle tube 11 having a needle tip 11A capable of puncturing a living body at the tip and the base end 11B side of the needle tube 11 and is attached to the peripheral surface of the needle tube 11 as an axis. It includes a holder 12 that partially covers in the direction, a needle tube 11 (needle tube 13 with a holder) to which the holder 12 is mounted, and a syringe (outer cylinder) 14 joined by insert molding.

The needle tube 11 is a portion punctured by the living body by the needle tip 11A as described above. A blade surface for sharpening the needle tip 11A is formed at the tip of the needle tube 11. The size of the needle tube 11 is not particularly limited, and for example, one having a gauge of 16 to 33 gauge (outer diameter: 1.7 to 0.2 mm) specified in ISO9626 can be used.

In the present embodiment, stainless steel (SUS304) is used as the material of the needle tube 11, but the material of the needle tube 11 is not limited to this, and other metals such as titanium alloy can be adopted. .. Further, in the present embodiment, the outer diameter of the needle tube 11 is substantially constant, but the outer diameter of the needle tube 11 is changed in the axial direction, for example, the outer diameter of the needle tip 11A side is made smaller than that of the base end 11B side. You may do it.

Further, in the present embodiment, the shape of the cross section of the needle tube 11 is circular, but the shape of the cross section of the needle tube 11 may be, for example, a polygonal shape. Further, the needle tube 11 may have a surface coated with a fluororesin or the like in order to reduce friction with the skin at the time of puncturing.

The holder 12 is a portion that is locked to the mold during insert molding and is a portion that is joined to the syringe 14. In the present embodiment, the holder 12 is attached to the needle tube 11 in advance to form a needle tube 13 with a holder having a portion having a diameter larger than that of the needle tube 11, and the syringe 14 is insert-molded integrally with the needle tube 13 with the holder. It is possible to manufacture the syringe 1 with a needle at low cost without complicating the mold and its peripheral devices.

The holder 12 is arranged on the base end 11B side of the needle tube 11, and is formed in a cylindrical shape that partially covers the outer peripheral surface of the needle tube 11 in the axial direction. In this embodiment, the holder 12 is attached (joined) to the needle tube 11 by welding or insert molding.

In the present embodiment, the tip portion 12A and the base end portion 12B of the holder 12 are portions that are locked to the mold when the needle tube 13 with the holder and the syringe 14 are insert-molded, and the tip portion 12A and the base end portion 12B The intermediate portion 12C between them is a portion to be joined to the syringe 14. Therefore, in the syringe 1 with a needle, the tip end portion 12A and the base end portion 12B of the holder 12 are exposed from the syringe 14.

In other words, in the present embodiment, the tip 12A and the base 12B of the holder 12 are locked by configuring the syringe 1 with a needle so that the tip 12A and the base 12B of the holder 12 are exposed from the syringe 14. It is possible to fix the needle tube 11 to the mold by the method. As a result, it becomes possible to manufacture the syringe 1 with a needle at low cost without complicating the mold and its peripheral devices.

The material of the holder 12 is not particularly limited, and an appropriate material such as various metals or various resins can be adopted. However, when the holder 12 is made of metal, it is preferable that the material of the holder 12 is the same or the same kind of metal as the needle tube 11 from the viewpoint of weldability with the needle tube 11. When the holder 12 is made of a resin, the material of the holder 12 is preferably the same or the same kind of resin as the syringe 14 from the viewpoint of the bondability with the syringe 14 by insert molding.

In the present embodiment, the holder 12 is formed in a cylindrical shape, but the holder 12 may have, for example, a C-shaped, U-shaped, or U-shaped cross section. Further, in the present embodiment, the outer shape of the holder 12 is formed in a columnar shape, but the outer shape of the holder 12 may be, for example, an elliptical columnar shape, a prismatic shape, a truncated cone shape, a truncated cone shape, or the like. , The outer peripheral surface may be provided with a stepped portion or an appropriate uneven shape.

The syringe 14 is a portion for accommodating a chemical solution or the like inside, and is configured in a bottomed cylindrical shape. The bottom portion of the syringe 14 on the distal end side is provided with a protruding portion 14A protruding toward the distal end side, and the needle tube 13 with a holder is joined to the protruding portion 14A. A plurality of ribs are provided on the outer periphery of the protruding portion 14A in order to prevent the occurrence of sink marks, voids, etc. during injection molding while ensuring the strength of the protruding portion 14A. Further, a cylindrical fitting portion 14B is provided on the tip end side of the protruding portion 14A. The fitting portion 14B is a portion that fits with a cap (not shown) for protecting the needle tube 11.

The inside of the needle tube 11 joined to the protrusion 14A via the holder 12 communicates with the inside of the syringe 14. The base end side of the syringe 14 is an opening for inserting a pusher (not shown). A ring-shaped flange 14C projecting outward is provided on the outer periphery of this opening. The shape of each part of the syringe 14 is not particularly limited, and any shape can be adopted.

The material of the syringe 14 is not particularly limited, but is preferably a transparent or translucent resin in which the chemical solution and the like contained therein can be visually recognized. In the present embodiment, the syringe 14 is made of cyclic polyolefin (COP), but the syringe may be made of, for example, cyclic olefin copolymer (COC) or polypropylene (PP).

Next, a method for manufacturing the syringe 1 with a needle will be described. 2A and 2B and FIGS. 3 to 5 are schematic views showing a method for manufacturing the syringe 1 with a needle. First, a case where the metal holder 12 is attached (joined) to the needle tube 11 by welding will be described.

In the first step, the holder 12 is attached to the needle tube 11. Specifically, first, as shown in FIG. 2A, the needle tube 11 is inserted into the cylindrical holder 12 and at a predetermined position on the base end 11B side of the needle tube 11 (in the present embodiment, the base end 11B of the needle tube 11). The holder 12 is arranged at a position where the side slightly protrudes from the holder 12. Then, the needle tube 11 and the holder 12 are fixed with an appropriate jig, and the tip surface 12A1 and the base end surface 12B1 of the holder 12 are irradiated with the laser beam L to weld the holder 12 to the needle tube 11. As a result, as shown in FIG. 2B, a molten portion 12D is formed at the welded portion, and a needle tube 13 with a holder in which the needle tube 11 and the holder 12 are integrated is obtained.

In this embodiment, laser welding that enables fine welding is adopted because the needle tube 11 has a relatively small diameter, but other welding methods such as arc welding, electron beam welding, or brazing are adopted. You may do it. Further, it is preferable that welding is performed over the entire circumference of the needle tube 11 in order to ensure the airtightness of the syringe 1 with a needle.

It is preferable that the outer peripheral surface of the holder 12 is subjected to, for example, a blast treatment in a preliminary step before the first step to form a rough surface in advance (provided with an uneven shape). By providing a rough surface on the outer peripheral surface of the holder 12, the contact area with the resin constituting the syringe 14 increases due to the unevenness of the surface and an anchor effect is generated. Therefore, the bondability and bonding strength with the resin constituting the syringe 14 are increased. Can be increased. In this case, the surface roughness Ra of the rough surface is preferably 0.2 μm or more, and more preferably 0.2 μm or more and 2.0 μm or less.

This preliminary step may be performed before the first step, or may be performed after the first step and before the second step described later. Further, the rough surface may be provided entirely on the holder 12, or may be partially provided, for example, only in the intermediate portion 12C. Further, a rough surface may be provided on the outer peripheral surface of the holder 12 by a method other than the blast treatment such as etching.

Next, in the second step, as shown in FIG. 3, the needle tube 13 with a holder is locked to the syringe mold 20 forming the syringe 14. In the present embodiment, a horizontal molding machine that opens and closes the syringe mold 20 in the lateral direction is used, and among the syringe molds 20, the first mold 21 that forms the tip end side of the syringe 14 is a movable side mold. The mold is used, and the second mold 22 forming the base end side of the syringe 14 is used as the fixed side mold.

The first mold 21 has a cavity 23 forming the periphery of the fitting portion 14B, a tip side needle tube accommodating portion 24 for accommodating the needle tip 11A side of the needle tube 11, and a tip to which the tip portion 12A of the holder 12 is locked. A side holder locking portion 24A and a tip side tapered portion 24B for guiding the tip portion 12A of the holder 12 to the tip side holder locking portion 24A are provided.

The tip side needle tube accommodating portion 24 has a deep hole having a circular cross section formed from the cavity 23 side, and is set to an inner diameter at which an appropriate gap is formed between the tip side needle tube accommodating portion 24 and the outer peripheral surface of the needle tube 11. The tip side holder locking portion 24A is provided with an enlarged diameter on the inlet side (cavity 23 side) of the tip side needle tube accommodating portion 24, and is provided between the inner diameter of the holder 12 and the outer peripheral surface of the holder 12. The inner diameter is set so that there is a gap so that the resin does not flow into the. The tip side tapered portion 24B is provided so as to gradually increase the diameter from the tip side holder locking portion 24A toward the cavity 23 side.

The second mold 22 includes a main body portion 25 forming the main portion of the syringe 14, a slide portion 26 forming the periphery of the protruding portion 14A of the syringe 14, and a core pin 27 forming the syringe 14 in a hollow shape. By combining these, a cavity 23 forming the proximal end side of the syringe 14 is configured. Further, at the tip of the core pin 27, a proximal end side needle tube accommodating portion 28 accommodating the proximal end 11B side of the needle tube 11 and a proximal end side holder locking portion 28A to which the proximal end portion 12B of the holder 12 is locked. , A proximal end side tapered portion 28B that guides the proximal end portion 12B of the holder 12 to the proximal end side holder locking portion 28A is provided.

Similar to the distal needle tube accommodating portion 24, the proximal end side needle tube accommodating portion 28 is a hole having a circular cross section formed from the cavity 23 side, and an appropriate gap is formed between the proximal end side needle tube accommodating portion 28 and the outer peripheral surface of the needle tube 11. It is set to the inner diameter. Similarly, the base end side holder locking portion 28A is provided with an enlarged diameter on the inlet side (cavity 23 side) of the base end side needle tube accommodating portion 28, and has an inner diameter to which the holder 12 fits or a holder 12. The inner diameter is set so that a gap is created between the outer peripheral surface and the outer peripheral surface so that the resin does not flow into the outer peripheral surface. Further, the base end side tapered portion 28B is provided so as to gradually increase the diameter from the base end side holder locking portion 28A toward the cavity 23 side.

Specifically, in the second step, with the syringe mold 20 open, the needle tip 11A side of the needle tube 11 is inserted into the needle tube accommodating portion 24 on the tip side of the first mold 21, and the tip portion of the holder 12 is inserted as it is. 12A is inserted into the tip side holder locking portion 24A and locked. As described above, the tip side holder locking portion 24A is set to the inner diameter where the holder 12 fits or the inner diameter where a relatively small gap is generated. Further, the tip portion 12A of the holder 12 is located at an intermediate portion in the axial direction of the needle tube 13 with a holder, that is, in the vicinity of the center of gravity.

Therefore, even in a horizontal molding machine, the tip portion 12A can be stably locked to the tip side holder locking portion 24A only by inserting the tip portion 12A of the holder 12 into the tip side holder locking portion 24A. Is possible. Further, since the tip end side tapered portion 24B guides the tip end portion 12A of the holder 12 to a position substantially concentric with the tip end side holder locking portion 24A, the tip end portion 12A can be inserted into the tip end side holder locking portion 24A. It has become easy.

The depth of the tip side needle tube accommodating portion 24 is such that the tip surface 12A1 of the holder 12 is in contact with the bottom surface 24A1 (step surface) of the tip side holder locking portion 24A, and the needle tip 11A of the needle tube 11 accommodates the tip side needle tube. The depth is set so as not to contact the bottom surface 24C of the portion 24. Therefore, the needle tube 13 with a holder is positioned axially with respect to the first mold 21 by bringing the tip surface 12A1 of the holder 12 into contact with the bottom surface 24A1 of the tip side holder locking portion 24A. There is.

Further, the inner diameter of the tip side needle tube accommodating portion 24 is set to be relatively large with respect to the outer diameter of the needle tube 11 because the inflow of resin is prevented in the tip side holder locking portion 24A. That is, the tip side needle tube accommodating portion 24 is configured so that when the tip end portion 12A of the holder 12 is locked to the tip end side holder locking portion 24A, the blade surface of the needle tube 11 or the like is unlikely to come into contact with the tip side needle tube accommodating portion 24. In the present embodiment, the needle tube 11 is prevented from being scratched or deformed on the needle tip 11A side.

Next, in the third step, the first mold 21 is moved toward the second mold 22, and as shown in FIG. 4, the first mold 21 is brought into contact with the second mold 22 to form a cavity. 23 is closed (that is, the syringe die 20 is closed). At this time, a portion protruding from the holder 12 on the proximal end 11B side of the needle tube 11 is accommodated in the proximal end side needle tube accommodating portion 28, and the proximal end portion 12B of the holder 12 is accommodated in the proximal end side holder locking portion 28A. It is housed inside and locked. Further, the base end surface 12B1 of the holder 12 comes into contact with the bottom surface 28A1 (step surface) of the base end side holder locking portion 28A, and the needle tube 13 with a holder is sandwiched between the first mold 21 and the second mold 22. To.

Therefore, in a state where the first mold 21 is brought into contact with the second mold 22 to close the cavity 23, the holder 12 is housed in a part in the axial direction, specifically, the tip side holder locking portion 24A. The intermediate portion 12C excluding the proximal end portion 12B housed in the distal end portion 12A and the proximal end side holder locking portion 28A is arranged in the cavity 23. Further, the tip surface 12A1 of the holder 12 abuts on the bottom surface 24A1 of the tip side holder locking portion 24A, and the base end surface 12B1 of the holder 12 abuts on the bottom surface 28A1 of the base end side holder locking portion 28A. 13 is positioned axially with respect to the syringe mold 20.

Since the base end portion 12B of the holder 12 is guided to a position substantially concentric with the base end side holder locking portion 28A by the base end side tapered portion 28B, the base end portion can be simply moved by simply moving the first mold 21. The portion 12B can be locked to the proximal end side holder locking portion 28A, and the proximal end 11B side of the needle tube 11 can be accommodated in the proximal end side needle tube accommodating portion 28.

Further, the depth of the base end side needle tube accommodating portion 28 is such that the base end 11B of the needle tube 11 contacts the bottom surface 28C in a state where the base end surface 12B1 of the holder 12 is in contact with the bottom surface 28A1 of the base end side holder locking portion 28A. It is set to a depth that does not. The inner diameter of the proximal end side needle tube accommodating portion 28 is set to be relatively larger than the outer diameter of the needle tube 11. That is, in the present embodiment, it is possible to prevent scratches, deformation, and the like from occurring even on the base end 11B side of the needle tube 11.

Next, in the fourth step, the cavity 23 is filled with resin, and the syringe 14 is integrally formed with the needle tube 13 with a holder. The resin filled in the cavity 23 is solidified in a state of wrapping the outer peripheral surface of the intermediate portion 12C of the holder 12 arranged in the cavity 23, whereby the needle tube 13 with the holder is joined to the syringe 14. That is, the syringe 14 is formed in a state of being partially bonded to the holder 12 in the axial direction, in other words, in a state of being partially bonded to the holder 12 in the axial direction.

Further, the tip portion 12A and the proximal end portion 12B of the holder 12, that is, the portions housed in the distal end side holder locking portion 24A and the proximal end side holder locking portion 28A do not substantially come into contact with the resin, and thus have a completed needle. The syringe 1 is exposed from the syringe 14.

Next, in the fifth step, as shown in FIG. 5, the syringe mold 20 is opened to release the syringe 1 with a needle, and if necessary, post-treatment such as deburring is performed. By the above procedure, the syringe 1 with a needle is completed. The state of the syringe mold 20 at the time of mold release shown in FIG. 5 is not always accurate.

As described above, in the present embodiment, the holder 12 having a diameter larger than that of the needle tube 11 is attached to the needle tube 11 in advance to form the needle tube 13 with a holder, and the stepped portion (that is, the tip of the holder 12) in the needle tube 13 with a holder is formed. Since the needle tube 11 is fixed (held) to the syringe mold 20 by utilizing the portion 12A and the base end portion 12B), the configuration of the syringe mold 20 and its peripheral devices is not complicated. It is possible to manufacture the syringe 1 with a needle at low cost.

Further, even a thin needle tube 11 having a gauge of 30 or more, which has been difficult to insert in the past, can be stably fixed to the syringe die 20 and integrally inserted with the syringe 14. There is. Further, since the needle tube 11 can be fixed to the syringe mold 20 without directly contacting the syringe mold 20 or the chuck member with the needle tube 11, it is possible to prevent the needle tube 11 from being scratched or deformed. Is possible.

Further, when the needle tube 11 is directly fixed to the syringe mold 20, the tip side needle tube accommodating portion 24, which is a deep hole with a small diameter, is processed with high accuracy to an inner diameter at which resin does not flow into the gap with the needle tube 11. Although it is necessary, in the present embodiment, since it is possible to prevent the inflow of the resin in the tip side holder locking portion 24A which is a shallow hole having a relatively large diameter, the processing accuracy of the tip side needle tube accommodating portion 24 is lowered. Is possible.

This makes it possible to reduce the manufacturing cost of the syringe mold 20. Further, by blocking the inflow of the resin in the tip side holder locking portion 24A, the tip side needle tube accommodating portion 24 can have a relatively large diameter, so that the needle tube caused by the contact with the tip side needle tube accommodating portion 24 can be made. It is possible to prevent the occurrence of flaws and deformations. Further, by configuring the tip side needle tube accommodating portion 24 to have a relatively large diameter, it becomes possible to make one syringe mold 20 correspond to the needle tubes 11 of a plurality of sizes.

Further, in the present embodiment, since the needle tube 13 with the holder is first supported by the tip side holder locking portion 24A, it is compared with the conventional technique of first supporting the base end side of the needle tube at the time of insert molding. , The proximal end side needle tube accommodating portion 28 and the proximal end side holder locking portion 28A can be configured shallowly. As a result, the recess 14D, which is a dead space because the tip surface of the gasket does not come into contact with the syringe 1 with a needle, can be configured to be shallower than before. That is, in the syringe 1 with a needle of the present embodiment, the amount of the chemical solution remaining in the syringe 14 after administration of the chemical solution or the like is smaller than that of the conventional syringe by insert molding.

In the present embodiment, the first mold 21 is a movable side mold and the second mold 22 is a fixed side mold, but the first mold 21 is a fixed side mold and the second mold 22 is used. May be a movable mold. Further, in the second to fifth steps, a vertical molding machine in which the first mold 21 and the second mold 22 are arranged vertically may be used. In this case, by arranging the first mold 21 on the lower side, the needle tube 13 with a holder can be stably fixed to the first mold 21.

Next, a case where the resin holder 12 is attached (joined) to the needle tube 11 by insert molding in the first step will be described. 6A to 6C are schematic views showing a method of mounting the holder 12 on the needle tube 11 by insert molding. In the first step in this case, insert molding is performed in which the holder 12 is integrally formed with the needle tube 11 by using a horizontal molding machine that opens and closes the holder mold 30 in the lateral direction.

The holder mold 30 is composed of a third mold 31 which is a movable side mold and a fourth mold 32 which is a fixed side mold. The third mold 31 is provided with a cavity 33 forming the holder 12 and a needle tube locking portion 34 for locking the base end 11B side of the needle tube 11. Further, the fourth mold 32 is provided with a needle tube accommodating portion 35 for a holder that accommodates the needle tip 11A side of the needle tube 11.

The needle tube locking portion 34 has a circular hole in a cross section formed from the cavity 33 side, and has a gap such that resin does not flow into the inner diameter of the needle tube 11 to which the needle tube 11 fits or the outer peripheral surface of the needle tube 11. It is set to the inner diameter that occurs. Further, the holder needle tube accommodating portion 35 has a deep hole having a circular cross section formed from the cavity 33 side (third mold side) so that the resin does not flow into the outer peripheral surface of the needle tube 11. It is set to the inner diameter where a gap is generated. The depth of the holder needle tube accommodating portion 35 is such that the needle tip 11A of the needle tube 11 does not contact the bottom surface 35A in a state where the third mold 31 is brought into contact with the fourth mold 32 to close the cavity 33. It is set to.

Specifically, in the first step in this case, first, as shown in FIG. 6A, with the holder mold 30 open, the base end 11B side of the needle tube 11 is inserted into the needle tube locking portion 34 to lock the needle tube 11. Let me. At this time, the base end 11B of the needle tube 11 comes into contact with the bottom surface 34A of the needle tube locking portion 34, so that the needle tube 11 is positioned in the axial direction. Next, the third mold 31 is moved toward the fourth mold 32, and as shown in FIG. 6B, the third mold is inserted into the holder needle tube accommodating portion 35 with the needle tip 11A side of the needle tube 11. The mold 31 is brought into contact with the fourth mold 32 to close the cavity 33 (that is, the holder mold 30 is closed). Then, the cavity 33 is filled with resin, and the holder 12 is integrally formed with the needle tube 11.

The resin filled in the cavity 33 is solidified in a state of partially enclosing the needle tube 11 in the axial direction, whereby the needle tube 11 is joined to the holder 12. Finally, as shown in FIG. 6C, the holder mold 30 is opened to release the formed needle tube 13 with a holder, and post-treatment such as deburring is performed as necessary. By the above procedure, the attachment of the holder 12 to the needle tube 11 is completed.

It is preferable that the outer peripheral surface of the needle tube 11 is subjected to, for example, a blast treatment in a preliminary step before the first step to form a rough surface in advance at a portion to be joined with the resin constituting the holder 12. By providing a rough surface on the outer peripheral surface of the needle tube 11, the bondability with the resin constituting the holder 12 can be enhanced. In this case, the surface roughness Ra of the primary surface is preferably 0.2 μm or more, and more preferably 0.2 μm or more and 2.0 μm or less.

In this way, the holder 12 may be attached to the needle tube 11 by insert molding. The holder mold 30 is smaller and has a simpler structure than the syringe mold 20, and the molding conditions such as injection pressure and holding pressure conditions at the time of insert molding are alleviated, so that the holder mold 30 is required more than the syringe mold 20. The processing accuracy is low, and it is possible to form the needle tube locking portion 34 and the needle tube accommodating portion 35 for the holder at low cost. Further, the holder 12 can be attached to the thin needle tube 11 of 30 gauge or more by insert molding.

That is, in the present embodiment, by performing the insert molding in two stages, the syringe 1 with a needle can be manufactured at a lower cost than in the case where the syringe 14 is integrally formed with the needle tube 11 by one insert molding. It is possible. Further, the syringe 1 with a needle provided with a thin needle tube 11 of 30 gauge or more, which was difficult to manufacture by one-time insert molding, can also be manufactured by insert molding.

In the holder mold 30, the third mold 31 may be a fixed-side mold and the fourth mold 32 may be a movable-side mold. Further, instead of the horizontal molding machine, a vertical molding machine in which the third mold 31 and the fourth mold 32 are arranged vertically may be used. In this case, by arranging the third mold 31 on the lower side, the needle tube 11 can be stably fixed to the third mold 31.

Next, a method for manufacturing the syringe 1 with a needle and a modified example of the syringe 1 with a needle will be described. 7 and 8 are schematic views showing a modified example of the manufacturing method of the syringe 1 with a needle. In this example, in the third step, the base end surface 12B1 of the holder 12 is brought into contact with the contact surface 28D provided at the tip end portion of the core pin 27 without locking the base end portion 12B of the holder 12 to the tip end portion of the core pin 27. I am trying to make it. Since the other parts are the same as the examples shown in FIGS. 1 to 6, only the different parts will be described below.

In this example, as shown in FIGS. 7 and 8, only the proximal end side needle tube accommodating portion 28 is provided at the tip end portion of the core pin 27, and an annular ring is provided on the outer periphery of the opening (entrance) of the proximal end side needle tube accommodating portion 28. The contact surface 28D is provided. Then, as shown in FIG. 7, in the third step, the first mold 21 is brought into contact with the second mold 22, so that the base end surface 12B1 of the holder 12 comes into contact with the contact surface 28D, whereby the holder is attached. The needle tube 13 is sandwiched between the first mold 21 and the second mold 22.

In the present embodiment, since the tip portion 12A of the holder 12 is locked to the tip side holder locking portion 24A, even if the base end surface 12B1 of the holder 12 is brought into contact with the contact surface 28D, the needle tube with a holder is used. 13 can be stably held and positioned. Then, in this example, in the third step, the base end portion 12B is arranged in the cavity 23 together with the intermediate portion 12C of the holder 12.

In the fourth step, the resin filled in the cavity 23 is solidified in a state of enclosing the intermediate portion 12C and the proximal end portion 12B of the holder 12 arranged in the cavity 23, whereby the needle tube 13 with the holder becomes a syringe. Joined with 14. Then, as shown in FIG. 8, the syringe mold 20 for a syringe is opened in the fifth step, and appropriate post-treatment is performed as necessary to obtain the syringe 1 with a needle of this example.

In the syringe 1 with a needle of this example, as shown in FIG. 8, the outer peripheral surfaces of the intermediate portion 12C and the proximal end portion 12B of the holder 12 are joined to the syringe 14. Therefore, in the syringe 1 with a needle of this example, the tip portion 12A of the holder 12 is exposed from the syringe 14, and only the proximal end surface 12B1 of the proximal end portion 12B of the holder 12 is exposed from the syringe 14.

In this way, instead of locking the base end portion 12B of the holder 12 to the tip end portion of the core pin 27 in the third step, the base end surface 12B1 of the holder 12 is brought into contact with the contact surface 28D of the tip end portion of the core pin 27. By making it only, it is possible to configure the recess 14D, which is a dead space, even shallower. That is, according to this example, the amount of the drug solution remaining in the syringe 14 after the administration of the drug solution or the like can be further reduced.

In this example, the outer diameter of the contact surface 28D is set to be substantially the same as the outer diameter of the holder 12, but the outer diameter of the contact surface 28D may be larger than the outer diameter of the holder 12. , May be small. Further, in this example, an appropriate tapered portion may be provided on the inlet side (cavity 23 side) of the proximal end side needle tube accommodating portion 28.

Other than that, although not shown, only the proximal end side needle tube accommodating portion 28 is provided at the tip end portion of the core pin 27 as in the examples shown in FIGS. 7 and 8, and the proximal end 11B of the needle tube 11 is provided on the proximal end side in the third step. It may be brought into contact with the bottom surface 28C of the needle tube accommodating portion 28. In this case, the base end side needle tube accommodating portion 28 can be configured to be shallower than the amount of protrusion from the holder 12 on the base end 11B side of the needle tube 11, and the resin can be brought into contact with the base end surface 12B1 of the holder 12. It is possible to construct the recess 14D, which is a dead space, even shallower. Further, the base end side needle tube accommodating portion 28 is further omitted from the examples shown in FIGS. 7 and 8, and the base end 11B (base end surface) of the needle tube 11 is brought into contact with the tip surface of the core pin 27 in the third step. May be good.

Further, the tip-side holder locking portion 24A may be composed of protrusions or ribs that partially or intermittently abut on the outer peripheral surface of the tip end portion 12A of the holder 12 in the circumferential direction. In this case, the resin may be prevented from flowing into the tip side needle tube accommodating portion 24 between the holder 12 and the tip surface 12A1.

When the tip side holder locking portion 24A is configured in this way, in the completed syringe 1 with a needle, the tip portion 12A of the holder 12 is partially exposed from the syringe 14. In other words, the syringe 1 with a needle may be such that at least the tip surface 12A1 of the tip portion 12A of the holder 12 is exposed from the syringe 14.

Similarly, the base end side holder locking portion 28A may be composed of protrusions or ribs that partially or intermittently abut the outer peripheral surface of the base end portion 12B of the holder 12 in the circumferential direction.

Further, when the base end side holder locking portion 28A is provided on the second mold 22, only one of the tip end surface 12A1 and the base end surface 12B1 of the holder 12 is the tip end side holder in the state where the syringe mold 20 is closed. It may be in contact with the bottom surface 24A1 of the locking portion 24A or the bottom surface 28A1 of the base end side holder locking portion 28A. That is, the needle tube 13 with a holder may be fixed to the syringe mold 20 with a predetermined degree of freedom in the axial direction.

Further, the material of the holder 12 and the method of joining to the needle tube 11 are not particularly limited, and in the first step, other known joining methods depending on the material such as welding, pressure welding, shrink fitting or caulking are adopted. can do. Further, even when the holder 12 is made of resin, a rough surface may be formed on the outer peripheral surface of the holder 12 before the second step. Further, the needle tube 13 with a holder may be configured so that the base end 11B side of the needle tube 11 does not protrude from the holder 12.

Although the embodiment of the present invention has been described above, the method for manufacturing a syringe with a needle and the syringe with a needle of the present invention are not limited to the above-described embodiment, and are within the range not deviating from the gist of the present invention. Of course, various changes can be made in. For example, the shape and arrangement of each part of the syringe 1 with a needle is not limited to the shape and arrangement shown in the present embodiment, and any shape and arrangement can be adopted. Similarly, the configurations of the syringe mold 20 and the holder mold 30 are not limited to the configurations shown in the present embodiment.

Moreover, the actions and effects shown in the above-described embodiments are merely a list of the most suitable actions and effects resulting from the present invention, and the actions and effects according to the present invention are not limited thereto.

1 Syringe with needle 11 Needle tube 11A Needle tip 11B Base end of needle tube 12 Holder 12A Tip of holder 12A1 Tip surface of holder 12B Base end of holder 12B1 Base end of holder 13 Needle tube with holder 14 Syringe 20 Syringe mold 21 No. 1 Mold 22 2nd mold 23 Syringe mold cavity 24 Tip side needle tube accommodating part 24A Tip side holder locking part 28A Base end side holder locking part 30 Holder mold 33 Holder mold cavity

Claims (9)

The first step of mounting a holder that partially covers the outer peripheral surface of the needle tube in the axial direction on the base end side of the needle tube having a needle tip at the tip.
With the syringe mold composed of the first mold and the second mold that are in contact with each other open, the tip side of the needle tube is inserted into the tip side needle tube accommodating portion provided in the first mold. In addition, the second step of locking the tip portion of the holder to the tip side holder locking portion provided on the inlet side of the tip side needle tube accommodating portion.
A third step of closing the syringe mold and arranging a part of the holder in the axial direction in the cavity of the syringe mold.
The fourth step of filling the cavity of the syringe mold with resin to form a syringe, and
A method for manufacturing a syringe with a needle, which comprises. In the method for manufacturing a syringe with a needle according to claim 1,
In the third step, a method for manufacturing a syringe with a needle, characterized in that the base end surface of the holder is brought into contact with the second mold. In the method for manufacturing a syringe with a needle according to claim 1 or 2.
In the third step, a method for manufacturing a syringe with a needle, characterized in that the base end portion of the holder is locked to the base end side holder locking portion provided in the second mold. The method for manufacturing a syringe with a needle according to any one of claims 1 to 3.
The first step is a method for manufacturing a syringe with a needle, which comprises welding the holder to the needle tube. In the method for manufacturing a syringe with a needle according to any one of claims 1 to 4.
A method for manufacturing a syringe with a needle, which comprises a preliminary step of forming a rough surface on the outer peripheral surface of the holder before the second step. The method for manufacturing a syringe with a needle according to any one of claims 1 to 3.
The first step is characterized in that the holder is formed by filling the cavity of the holder mold with a resin in a state where a part of the needle tube in the axial direction is arranged in the cavity of the holder mold. How to manufacture a syringe with a needle. In the method for manufacturing a syringe with a needle according to claim 5.
A method for manufacturing a syringe with a needle, which comprises a preliminary step of forming a rough surface on the outer peripheral surface of the needle tube before the first step. A needle tube having a needle tip at the tip, and a needle tube with a holder attached to the base end side of the needle tube and having a holder that partially covers the outer peripheral surface of the needle tube in the axial direction.
A syringe, which is joined to the needle tube with a holder by insert molding, is provided.
The holder is a syringe with a needle, characterized in that at least the tip surface is exposed from the syringe. In the syringe with a needle according to claim 8,
The holder is a syringe with a needle, characterized in that the proximal end surface is exposed from the syringe.

Images