WO2013115184A1

WO2013115184A1 - Method for producing hypodermic needle, and hypodermic needle

Info

Publication number: WO2013115184A1
Application number: PCT/JP2013/051904
Authority: WO
Inventors: 秀雄川本; まどか堀江
Original assignee: テルモ株式会社
Priority date: 2012-01-31
Filing date: 2013-01-29
Publication date: 2013-08-08
Also published as: JPWO2013115184A1

Abstract

A method for producing a hypodermic needle involves a step for forming a piercing surface on one end of a metal needle shaft using wire electric discharge machining, and a polishing step for polishing the piercing surface by subjecting the needle shaft on which the piercing surface is formed to ion-etching in a vacuum environment, wherein burrs formed on the needle shaft when forming the piercing surface are polished using ion-beam irradiation. The polishing step involves: immobilizing a hypodermic needle, on which a piercing tip is formed, using an immobilizing tool for immobilizing one end of the needle shaft, in a vacuum furnace; irradiating with an ion beam using plasma ions in a vacuum environment; and at least polishing the needle shaft that includes the piercing tip. The present invention makes it possible to easily and efficiently produce a hypodermic needle and improve producibility, and furthermore, to make the piercing tip sharper and reduce the wound and pain caused by piercing.

Description

Manufacturing method of injection needle and injection needle

The present invention relates to an injection needle for administering a drug solution and a method for producing the same.

When manufacturing an injection needle used to administer a drug solution to the human body, conventionally, a tubular body having a desired outer diameter is formed while pulling out a small-diameter metal tube, and then a cutting edge for puncturing the human body is formed. It is formed by cutting at a predetermined angle with respect to the longitudinal direction of the tubular body. A method of manufacturing an injection needle is known in which a tubular body with a blade edge is polished to a surface roughness of about 1 to several tens of μm for the purpose of reducing puncture pain and scratches as much as possible. (For example, Patent Document 1)
In this case, wire cutting, cutting, electric discharge machining, or the like is used as a method for forming the cutting edge. When the cutting edge is formed by these processes, electrolytic polishing or chemical polishing is used to remove burrs generated in the cutting edge forming process. A cleaning process using a cleaning method such as (cleaning process) was necessary. (For example, Patent Document 2)
However, the conventional manufacturing method using the cleaning process using these cleaning methods has a problem that the number of processes increases in manufacturing the injection needle.

Also, depending on the cleaning process conditions such as electrolytic polishing and chemical polishing, there is a problem that it is difficult to sharpen the blade edge.

Japanese Patent Publication No. 61-28472 JP 2007-54194 A

An object of the present invention is to provide a method for manufacturing an injection needle and an injection needle that enable an injection needle to be manufactured easily and efficiently and make the blade edge sharper.

The present invention is as follows in order to solve the problem.

That is,
(1) The present invention is a method for manufacturing an injection needle used for injecting a chemical solution, wherein a cutting edge is formed by wire electric discharge machining on at least one end of a needle tube, and a cutting edge forming step for forming the injection needle is formed. And a polishing step of performing ion etching on the injection needle in a vacuum atmosphere.

Thereby, an injection needle can be manufactured easily and efficiently.
(2) In the method of manufacturing an injection needle of the present invention, the polishing step is performed in a vacuum atmosphere by fixing the injection needle on which the needle tip is formed with a fixture for fixing one end of the needle tube in a vacuum atmosphere. In this case, it is preferable to polish the needle tube including at least the needle tip by irradiating with an ion beam using plasma ions.

Thereby, a sharper cutting edge can be formed and an injection core can be easily manufactured.

(3) In the manufacturing method of the injection needle of the present invention, in the manufacturing method, the needle tube has an outer diameter on the one end side smaller than an outer diameter on the other end side,
A blade edge is formed in the blade edge forming step on the one end side where at least the outer diameter is small,
It is preferable that the other end side is fixed by the fixing tool and the polishing step is performed.

This makes it possible to easily form an interval between adjacent cutting edges when performing the polishing process of the cutting edges of a large number of needle tubes, and the polishing process can be performed efficiently.

(4) In the injection needle manufacturing method of the present invention, it is preferable that the injection needle is made of a tapered needle tube having an inner diameter and an outer diameter on one end side larger than an inner diameter and an outer diameter on the other end side.

(5) In the injection needle manufacturing method of the present invention, in the manufacturing method, it is preferable that the needle tube further includes a pressing step in which a strip-shaped metal plate member is processed into a tubular body by press forming.

(6) In the manufacturing method of the injection needle of the present invention, it is preferable that the injection needle has two or more portions having different inner diameters.

(7) In the manufacturing method of the injection needle of the present invention, it is preferable that the manufacturing method irradiates an ion beam using a plasma ion gas using argon as a medium in a vacuum atmosphere.

(8) The present invention relates to a method for manufacturing an injection needle used for injecting a chemical solution, a blade tip forming step of forming a needle tip at least at one end of a needle tube to form the needle, and an injection needle with the blade tip formed Is a method of manufacturing a syringe needle having a polishing step in which an interval between adjacent needle tubes at the one end is at least 0.03 mm.

(9) In the method for manufacturing an injection needle of the present invention, the polishing step is performed in a vacuum atmosphere by fixing the injection needle on which the needle tip is formed by a fixture for fixing one end of the needle tube in a vacuum atmosphere. It is preferable to irradiate an ion beam using plasma ions and to polish a needle tube including at least the needle tip.

(10) The present invention is an injection needle manufactured by the method for manufacturing an injection needle according to any one of (1) to (9) above.

According to the present invention, the injection needle can be manufactured easily and efficiently, and the productivity can be improved. In addition, the cutting edge can be sharpened, and puncture pain and wounds can be reduced.

In particular, in the injection needle that forms the cutting edge using wire cutting, the number of steps at the time of manufacture can be reduced, and it can be manufactured easily and efficiently.

FIG. 1 is a cross-sectional view showing an embodiment of the injection needle of the present invention. FIG. 2 is a process diagram showing an embodiment of a method for producing an injection needle of the present invention. FIG. 3 is a diagram showing a press molding step of the method for manufacturing the injection needle shown in FIG. FIG. 4 is a diagram showing a press molding step of the method for manufacturing the injection needle shown in FIG. FIG. 5 is a diagram showing a press molding step of the method for manufacturing the injection needle shown in FIG. FIG. 6 is a diagram showing a press molding step of the method for manufacturing the injection needle shown in FIG. FIG. 7 is a diagram showing a separation step of the manufacturing method of the injection needle shown in FIG. FIG. 8 is a diagram showing a blade attaching step of the method for manufacturing the injection needle shown in FIG. FIG. 9 is a diagram showing a polishing step of the method for manufacturing the injection needle shown in FIG. FIG. 10 is a diagram showing a first assembly process of the method of manufacturing the injection needle shown in FIG. FIG. 11 is a diagram showing a first assembly step of the method for manufacturing the injection needle shown in FIG. FIG. 12 is a diagram showing a first assembly process of the manufacturing method of the injection needle shown in FIG. FIG. 13 is a diagram showing a first assembly process of the manufacturing method of the injection needle shown in FIG. FIG. 14 is a diagram showing a first assembly process of the manufacturing method of the injection needle shown in FIG. FIG. 15 is a diagram showing a first assembly process of the method of manufacturing the injection needle shown in FIG. FIG. 16 is a diagram showing a first assembly process of the manufacturing method of the injection needle shown in FIG.

Hereinafter, a method for manufacturing an injection needle and an injection needle according to the present invention will be described in detail based on embodiments shown in the drawings.

First, the injection needle manufactured by the manufacturing method of the present invention will be described.

As shown in FIG. 1, an injection needle 1 manufactured by the manufacturing method of the present invention includes a metal needle tube (hollow needle) 3 and a hub 2 to which the needle tube 3 is fixed (fixed). The injection needle 1 is used, for example, by being detachably attached to a distal end portion of a drug solution container such as a prefilled syringe in which drug solutions such as insulin, various vitamins, antithrombotic agents, and antibiotics are stored in advance. The injection needle 1 is formed with a thread groove for screwing with a screw thread 21 formed on the hub 2 described later at the tip of a liquid container such as a prefilled syringe.

The hub 2 of the injection needle 1 is formed on a hub body 23 having a bottomed cylindrical shape and a distal end side and a proximal end side of the bottom portion of the hub body 23, and the outer diameter thereof is smaller than the outer diameter of the hub body 23. And

parts

24 and 25.

A thread 21 that is screwed into the thread groove is formed on the inner peripheral surface of the hub body 23. Further, a through hole 22 is formed at substantially the center of the bottom portion of the hub body 23 and the

small diameter portions

24 and 25. In addition, a concave portion 26 that is in communication with the through hole 22 and is filled with the adhesive 7 is formed at the tip of the small diameter portion 24.

The needle tube 3 is inserted into the lumen portion of the through hole 22 and fixed (fixed) to the hub 2 by bonding with the adhesive 7. In this case, the needle tube 3 is fixed to the hub 2 at a midway position in the longitudinal direction. The method for fixing the needle tube 3 is not limited to adhesion, and other methods such as fusion (thermal fusion, ultrasonic fusion, high frequency fusion), caulking, etc. may be used.

Examples of the constituent material of the hub 2 include various resins such as polyvinyl chloride, polyethylene, polypropylene, polystyrene, polycarbonate, and acrylic resin.

As shown in FIG. 1, the needle tube 3 is a double-ended needle, and includes a needle body 4, a sharp first needle tip 5 provided at one end of the needle body 4, and the other end of the needle body 4 (first It has a sharp second needle tip 6 provided at the end opposite to the needle tip 5), and these are integrally formed.

A tip surface 51 is formed on the first needle tip 5, and a tip surface 61 is formed on the second needle tip 6. In other words, the portion of the needle tube 3 where the distal end surface 51 is formed (the portion indicated by the length L1 in FIG. 1) constitutes the first needle tip 5 and the distal end surface 61 is formed. The portion (the portion indicated by the length L2 in FIG. 1) constitutes the second needle tip 6, and the other portions constitute the needle body 4.

The first needle tip 5 of the needle tube 3 protrudes inside the hub 2, and the second needle tip 6 protrudes outside the hub 2. That is, the first needle tip 5 is located on the proximal end side of the hub 2, and the second needle tip 6 is located on the distal end side of the hub 2. The first needle tip 5 of the needle tube 3 is used by being pierced with a plug made of an elastomer such as various natural rubbers provided at the tip of a chemical liquid container such as the prefilled syringe described above, while the second needle The tip 6 is used by puncturing a living body.

In this injection needle 1, a blade is formed on at least one of the first needle tip 5 and the second needle tip 6. Further, in the needle tube 3, the central axis thereof is substantially straight from the first needle tip 5 and the second needle tip 6, that is, from the distal end to the proximal end (over the whole). Thereby, increase of the piercing resistance in both the first needle tip 5 and the second needle tip 6 can be prevented.

Further, the needle tube 3 has two or more parts having different inner diameters (diameters) and two or more parts having different outer diameters (diameters). Specifically, the inner diameter and the outer diameter of the needle tube 3 are maximum at the proximal end and minimum at the distal end, and gradually decrease from the proximal end side toward the distal end side. That is, the inner diameter and the outer diameter of one end of the needle tube 3 are larger than the inner diameter and the outer diameter of the other end, and the needle tube 3 is positioned so that one end having the larger inner diameter and outer diameter is located on the proximal end side of the hub 2. , Fixed to the hub 2.

With such a configuration, the outer diameter of the second needle tip 6 that is punctured into the living body is increased while sufficiently securing the volume of the internal flow path of the needle tube 3 as compared with an injection needle having a constant inner diameter and outer diameter. The needle tube 3 has an excellent effect that pain to the user can be reduced while preventing the passage resistance of the chemical solution from increasing.

From this point of view, the dimensions of each part of the needle tube 3 are set as follows, for example. Hereinafter, the end portions of the distal end surface 51 (first needle tip 5) and the distal end surface 61 (second needle tip 6) on the side of the needle body 4 are respectively referred to as the distal end surface 51 (first needle tip 5). The root portion and the root portion of the tip surface 61 (second needle tip 6) are referred to.

The outermost diameter on the most proximal side that is the maximum outer diameter of the needle tube 3, that is, the outer diameter of the root of the first needle tip 5 (diameter φ1 in FIG. 1) is preferably 0.6 mm or less. It is more preferably about 2 to 0.6 mm, and further preferably about 0.35 to 0.6 mm.

The inner diameter of the most proximal side that is the maximum inner diameter of the needle tube 3, that is, the inner diameter of the root portion of the first needle tip 5 (diameter φ2 in FIG. 1) is preferably 0.5 mm or less, 0.12 to 0 More preferably, it is about 0.5 mm, more preferably about 0.25 to 0.5 mm.

The length of the first needle tip 5 (length L1 in FIG. 1) is preferably 3 mm or less, more preferably about 0.5 to 1.5 mm, and 0.5 to 1.2 mm. More preferably, it is about.

On the other hand, the outermost diameter on the most distal side which is the minimum outer diameter of the needle tube 3, that is, the outer diameter of the root portion of the second needle tip 6 (diameter φ3 in FIG. 1) is preferably 0.3 mm or less. It is more preferably about 1 to 0.25 mm, and further preferably about 0.1 to 0.22 mm.

The innermost diameter on the most distal side, that is, the inner diameter at the root of the second needle tip 6 (diameter φ4 in FIG. 1), which is the minimum inner diameter of the needle tube 3, is preferably 0.2 mm or less, 0.05 to 0. It is more preferably about 15 mm, and further preferably about 0.05 to 0.1 mm.

The length of the second needle tip 6 (length L2 in FIG. 1) is preferably 3 mm or less, more preferably about 0.2 to 2.0 mm, and 0.5 to 1.5 mm. More preferably, it is about.

The maximum height difference (Rf) of the surface roughness according to JIS-B-0601-1994 of the inner surface of the needle tube 3 is preferably 3 μm, more preferably 2 μm or less, and 1 μm or less. More preferably, it is about 0.1 to 1 μm.

Examples of the material of the needle tube 3 include metal materials such as stainless steel, aluminum or aluminum alloy, titanium or titanium alloy.

The shape and structure of the needle tube 3 are not limited to those described above. For example, a sharp needle tip and a blade are not formed at one end portion of the needle tube, and only the other end portion is sharp. A sharp needle tip is formed at one end of a needle tube having a needle tip and a blade, but no blade is formed, and a sharp needle tip and only at the other end One having a blade, one having a constant inner diameter, one having a part having a constant inner diameter, two or more parts having different inner diameters, and at least one of the two or more parts is longitudinal One having a predetermined length along the direction, one having a part where the inner diameter gradually decreases from the proximal side to the distal side (toward the distal direction), the inner diameter is maximum at the proximal end, and the distal end A portion having a portion that gradually decreases from the proximal end side toward the distal end side, Some have a part where the diameter gradually increases from the proximal side to the distal side (toward the distal direction), and the inner diameter is the smallest at the proximal end, the largest at the distal end, and from the proximal end to the distal side. Those that gradually increase in the direction, the inner diameter is the smallest at the proximal end, the largest at the distal end, and have a part that gradually increases from the proximal end side toward the distal end side, the inner diameter of the proximal end (one end side) However, what is smaller than the internal diameter of a front-end | tip (other end side) and what combined two or more of these structures arbitrarily may be used.

Next, as an embodiment of the manufacturing method of the injection needle of the present invention, the manufacturing method of the injection needle 1 shown in FIG. 1 will be sequentially described with reference to FIGS.

As shown in FIG. 2, the method for manufacturing the injection needle 1 includes a step of receiving a strip-shaped metal plate material in a press molding machine, and continuously pressing the plate material by the press molding machine. A press forming step for obtaining a plurality of pipes partially connected to each other, a joining step for bonding the joint portions of the pipes by welding or an adhesive, and a central axis of the pipes to be substantially straight And forming a needle by forming a cutting edge by wire electric discharge machining at least one end of the tube, and a correction step of correcting the shape of the tube, a separation step of separating the tube from the plate material A blade attaching step, a polishing step of polishing the injection needle by ion etching, an assembly step of fixing the injection needle to a hub and assembling the injection needle, an inspection step of inspecting the injection needle, and the injection Collect a specified number of needles It has a packaging step for packaging, and a sterilization process sterilizing the packaged needle. Hereinafter, each of these steps will be described sequentially.

<Acceptance process>
The strip-shaped metal plate is received by a press molding machine (not shown). In this case, the plate material is moved along the longitudinal direction with respect to the press molding machine by a moving mechanism (not shown), and the molding position of the plate material is positioned at the molding position of the press molding machine. That is, first, a portion of a plate material where a later-described developed shape body is punched is disposed at a position of a later-described punching portion that punches the developed shape body of the press molding machine. In addition, as a constituent material of a board | plate material, metal materials, such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy, are mentioned similarly to the constituent material of the above-mentioned needle tube 3, for example.

<Press molding process>
In the press molding process, the developed shape body is punched out from the plate material with the press molding machine in a state in which a part of the developed shape body, which is formed by expanding the tubular body, is partially connected to the plate material, and the developed shape body is formed by the press molding machine. And a second step of obtaining a tubular body that is bent at least once using a convex mold and a concave mold and formed into a tubular shape and partially connected to a plate material. As shown in FIG. 6, in this embodiment, the tubular body 9 has an inner diameter and an outer diameter that are maximum at one end and minimum at the other end, and gradually decrease from the one end toward the other end.

As the press molding machine, as shown in FIGS. 3 to 6, the unfolded shape body 81, which is a shape in which the tubular body 9 is unfolded from the plate material 8, is mechanically punched in a state where a part is connected to the plate material 8. A first bent portion 11 for bending a punched portion and a developed shape body 81 punched by the punched portion using a concave mold (mold) 111 and a convex mold (mold) 112, and the first bent section 11 The second bent portion 12 that is further bent using the concave mold (mold) 121 and the convex mold (die) 122, and the second bent section 12 is bent by the second bent section 12. The bent shape 81 is further bent using a pair of concave dies (die) 131 and 132 having a shape corresponding to the outer shape of the tube body 9, and is formed into a tubular shape (the shape of the tube body 9). A continuous press molding machine having part 13 is used.

In this press molding process, first, as shown in FIG. 3, the portion of the plate material 8 where the developed shape body 81 is punched is disposed at the position of the punched portion, and the punched portion from the plate material 8, A developed shape body 81 having a shape obtained by developing the tube body 9 is punched out. In this case, in the developed shape body 81, the longitudinal direction of the tube body 9 is a direction (width direction) substantially perpendicular to the longitudinal direction of the plate member 8, and a part of the developed shape body 81, that is, the developed shape body 81. The center portion of one end portion in the direction substantially perpendicular to the longitudinal direction of the plate material 8 and the center portion of the other end portion are each punched out in a state of being connected to the plate material 8 via the connection portion 82. It is. Hereinafter, the direction substantially perpendicular to the longitudinal direction of the plate material 8 is also simply referred to as “the width direction of the plate material 8”.

Next, as shown in FIG. 4, the plate member 8 is moved along the longitudinal direction with respect to the press molding machine by a moving mechanism (not shown), and the developed shape body 81 punched by the punching portion is subjected to the first bending. While arrange | positioning in the position of the part 11, the site | part where the expansion | deployment shape body 81 of the board | plate materials 8 is punched next is arrange | positioned in the position of a punching part. Then, the developed shape body 81 is pressed and bent by the concave mold 111 and the convex mold 112 of the first bending portion 11 so that the longitudinal direction of the tube body 9 is the width direction of the plate member 8. At the same time, as described above, the developed shape body 81 is punched from the plate member 8 by the punching portion.

Next, as shown in FIG. 5, the unfolded moving body 81 is moved along the longitudinal direction of the plate 8 with respect to the press molding machine by a moving mechanism (not shown), and the developed shape body 81 curved by the first bending portion 11 is moved. The developed shape body 81 placed at the position of the second bent portion 12 and punched out by the punching portion is arranged at the position of the first bent portion 11, and the developed shape body 81 of the plate material 8 is The part to be punched is arranged at the position of the punching part. Then, the developed shape body 81 is further pressed and curved by the concave mold 121 and the convex mold 122 of the second bending portion 12 so that the longitudinal direction of the tube body 9 is the width direction of the plate member 8. At the same time, as described above, the developed shape body 81 is pressed by the first bending portion 11 to be bent, and the developed shape body 81 is punched from the plate member 8 by the punched portion.

Next, as shown in FIG. 6, the unfolded moving body 81 is moved along the longitudinal direction of the plate material 8 with respect to the press molding machine by a moving mechanism (not shown), and the developed shape body 81 curved by the second bending portion 12 is obtained. The unfolded shape 81, which is disposed at the position of the third bent portion 13 and curved by the first bent portion 11, is disposed at the position of the second bent portion 12, and is punched by the punched portion. The body 81 is disposed at the position of the first bent portion 11, and the portion of the plate member 8 where the developed shape body 81 is punched next is disposed at the position of the punched portion. Then, the developed shape body 81 is further pressed and curved by the

concave molds

131 and 132 of the third bending portion 13 so that the longitudinal direction of the tube body 9 is the width direction of the plate member 8, and the tubular shape (tube body 9). Shape). At the same time, as described above, the developed shape body 81 is pressed by the second bending portion 12 to be further curved, and the developed shape body 81 is pressed by the first bending portion 11 to be curved. At the same time, the developed shape body 81 is punched from the plate member 8 by the punching portion.

Hereinafter, similarly, the plate member 8 is moved along the longitudinal direction with respect to the press molding machine by a moving mechanism (not shown), and the punching portion, the first bending portion 11, the second bending portion 12, and the third portion are moved. The plurality of tube bodies 9 that are continuously press-formed by the bent portions 13 and partially connected to the plate material 8, that is, the plate material 8, are arranged in the width direction of the plate material 8 through a pair of connection portions 82. A plurality of tube bodies 9 in which both ends are connected are obtained. Thus, in the press molding process, the longitudinal direction of the tube body 9 is a direction (width direction) substantially perpendicular to the longitudinal direction of the plate material 8, and a plurality of tube bodies are arranged along the longitudinal direction of the plate material 8. 9 are arranged in parallel at substantially equal intervals. In the press molding process, the end of the tube 9 having the smaller diameter is formed by deforming the connecting portion 82 that connects the end of the tube 9 having the smaller diameter to the plate member 8 toward the upper side in the drawing. The portion moves upward by a predetermined amount in the figure, whereby the central axis of the tube body 9 and the surface (plane) of the plate material 8 become substantially parallel.

Thus, in the press molding process, the plate material 8 is continuously press-molded to form the tube body 9, so that a plurality of tube bodies 9 can be manufactured easily and quickly, thereby improving productivity. Can be made. In the present invention, the end of the tube 9 having the larger diameter is formed by deforming the connecting portion 82 that connects the end of the tube 9 having the larger diameter to the plate 8 toward the lower side in the drawing. May be moved downward by a predetermined amount in the figure, so that the central axis of the tube body 9 and the surface of the plate member 8 become substantially parallel. Further, the connecting portion 82 for connecting the end portion of the tube body 9 having the smaller diameter to the plate material 8 is deformed toward the upper side in the figure, and the end portion having the larger diameter of the tube body 9 is connected to the plate material 8. When the connecting portion 82 is deformed downward in the drawing, the end portion of the smaller diameter of the tube body 9 is moved by a predetermined amount to the upper side of the drawing, and the end of the larger diameter portion of the tube body 9 is moved. The portion may move a predetermined amount downward in the figure, so that the central axis of the tube body 9 and the surface of the plate 8 may be substantially parallel. In the present invention, the third bent portion 13 is located between the concave mold 131 and the concave mold 132 (inside the concave molds 131 and 32), and further includes a core (mold) (not shown) having a shape corresponding to the inner shape of the tube body 9. It may be arranged so that the core is located in the lumen of the tube body 9, and the developed shape body 81 may be pressed and curved to be formed into a tubular shape.

Further, in the present invention, the method of punching the developed shape body 81 from the plate member 8 is not limited to the mechanical punching method, and may be punched using a laser or the like, for example.

<Joint process>
In the joining step, the joint 83 (see FIG. 6) of each tube body 9 is bonded by welding or an adhesive. Thereby, the portion of the joint 83 of the tube body 9 is liquid-tightly and firmly joined. In this case, welding and bonding with an adhesive are preferable because the tube 9 is made of metal and the outer diameter of the tube 9 is relatively small. At the time of welding, it is preferable to melt and weld the joint (including the joint 83) including the base material.

Various types of welding (welding methods) can be used for welding. For example, laser welding such as carbon dioxide laser welding, YAG laser welding, and excimer laser welding is preferable, and among these, they are inexpensive and fine. Carbon dioxide laser welding or YAG laser welding suitable for processing is particularly preferred.

<Correction process>
In the correction step, the shape of each tube 9 is corrected so that the central axis of each tube 9 is substantially a straight line. In this case, for example, a pair of rollers (not shown) arranged at a predetermined distance from each other is used, and the tube body 9 is disposed between the pair of rollers to pass therethrough. As a result, the tube body 9 is pressed and corrected between the rollers so that the central axis thereof is substantially straight. In the present invention, the correction may be performed by other methods.

<Separation process>
In the separation step, each tube body 9 is sequentially separated from the plate material 8. In this case, the tube body 9 is separated at the boundary between the tube body 9 and the pair of connection portions 82. The method for separating the tube body 9 from the plate member 8 is not particularly limited, and may be mechanically cut or may be cut using a laser or the like.

Also, in the separation step, each tubular body 9 is temporarily fixed substantially simultaneously with the separation of the tubular bodies 9 or after the separation of the tubular bodies 9, and the positional relationship between the tubular bodies 9 is maintained. In the present embodiment, the temporary fixing is performed by attaching both ends of the tube body 9 to a pair of adhesive tapes (temporary fixing members) 14 as shown in FIG. 7 (the center of the tube body 9 in the longitudinal direction). At least one place excluding the portion is attached to the adhesive tape 14).

The interval between the temporarily fixed adjacent tube bodies 9 is not particularly limited (there may be no interval), and is appropriately set according to various conditions, but the adjacent tubes partially connected to the plate member 8. It is preferable to set it smaller than the interval between the bodies 9. Thereby, each tubular body 9 can be arranged densely, and in the next process (blade attaching process), needle tips having blades can be formed simultaneously on a large number of tubular bodies 9, thereby Productivity can be improved. The interval between the adjacent tubular bodies 9 in the temporary fixing can be arbitrarily adjusted by adjusting the moving amount (feeding pitch) of the adhesive tape 14. For example, in order to make the interval between adjacent tube bodies 9 in temporary fixing smaller than the interval between adjacent tube bodies 9 partially connected to the plate member 8, the previous tube body 9 is attached to the adhesive tape 14. The amount of movement of the pressure-sensitive adhesive tape 14 from the time when the next tube 9 is adhered to the pressure-sensitive adhesive tape 14 to the pitch of the adjacent tube 9 in a state where a part is connected to the plate material 8 (the previous tube). It is set to be smaller than the amount of movement of the plate material 8 from when 9 is separated until the next tube body 9 is separated.

<Bladeing process>
In the blade attaching step, an injection needle is formed by forming a blade (blade surface) at at least one end of each tube body 9 and forming a needle tip. In this case, a blade is simultaneously formed on each tubular body 9 while maintaining the positional relationship between the tubular bodies 9. In this way, since the blade is formed while maintaining the positional relationship between the tubular bodies 9, the blade can be easily, reliably and accurately formed, and the blades are simultaneously formed on each tubular body 9. Therefore, productivity can be improved.

In the present embodiment, in the blade attaching step, each tubular body 9 is held at a substantially central portion in the longitudinal direction, and the positional relationship between the tubular bodies 9 is maintained. That is, as shown in FIG. 8, a pair of adhesive tapes 14 is provided by a holding mechanism 15 having a pair of long gripping portions (holding portions) 151 that hold (hold) substantially the center portion of each tube body 9. The positional relationship between the tubular bodies 9 that are pasted and temporarily fixed is maintained as it is. And the front end surface 51 which has a blade in the site | part which is not affixed on the adhesive tape 14 of the edge part of one side (upper part in Fig.8 (a)) of each tubular body 9 is formed, and the 1st needle tip 5 is attached. A second needle tip 6 is formed by forming a tip surface 61 having a blade at a portion not formed on the adhesive tape 14 at the other end (lower side in FIG. 8B). . Thereby, each adhesive tape 14 is removed from the needle tube 3 in which the first needle tip 5 and the second needle tip 6 are formed.

As a method of forming the tip surface 51 and the tip surface 61, that is, a method of forming the first needle tip 5 and the second needle tip 6, wire cut processing such as wire cut electric discharge machining is used. According to such a forming method, the tip surface 51 and the tip surface 61 having a desired shape can be easily and reliably formed.

In the present invention, in this blade attaching step, for example, a first end surface 51 having a blade is formed at one end of the tube body 9 (the end protruding to the inside of the hub 2), and the first end surface 51 is formed. The needle tip 5 is formed, and the second needle tip 6 is not formed at the other end (the end protruding to the outside of the hub 2), and after the cutting process (for example, in the assembly process, After the needle tube 3 is fixed to the hub 2, the tip surface 61 having a blade may be formed at the other end portion to form the second needle tip 6. Further, in this blade attaching step, for example, the tip surface 51 having no blade is formed at one end portion of the tube body 9 to form the first needle tip 5, and the blade is provided at the other end portion. You may form the 2nd needle tip 6 by forming the front end surface 61 which has. In addition, in the case where the manufactured injection needle is not a double-ended needle but an injection needle having a needle tip only at one end, in this blade attaching process, only one end or the other end of the tube body 9 is provided. The tip end surface having the blade is formed to form the needle tip.

<Polishing process>
In the polishing step, the needle tube 3 on which the first needle tip 5 and the second needle tip 6 are formed is polished. As a polishing method, ion etching processing is performed on the needle tube 3 on which the first needle tip 5 and the second needle tip 6 are formed using a plasma ion gas in a vacuum atmosphere and using argon as a medium. According to this polishing method, burrs generated during wire electric discharge machining can be dissolved and vaporized, and the first needle tip 5 and the second needle tip 6 including the tip surface 51 and the tip surface 61 having a desired shape are formed. The needle tube 3 can be easily and reliably polished.

At the same time, it is possible to remove contamination caused by metal adhesion to the machined surface that occurs during wire electric discharge machining.

In this embodiment, the vacuum chamber 100 includes a plasma ion implantation gun 200 that performs ion beam processing as shown in FIG. 9A, a gas injection device 400, and a needle tube fixing base 500. A needle tube fixing base 500 in a state in which a plurality of needle tubes 3 are held at predetermined intervals by a holding mechanism 15 in a needle tube 3 in which a first needle tip 5 and a second needle tip 6 are formed. Then, argon gas Ar is introduced into the vacuum chamber 100 from the gas injection device 400 at a predetermined pressure, and Argon ions Ar ⁺ and electrons are introduced from the Ar gas introduced by applying a predetermined voltage condition in the vacuum chamber 100. e ^- and becomes a plasma state separated, and the ion beam in the first needle tip 5 and the second needle tube 3 needlepoint 6 is formed by only argon ions are extracted It is irradiated Te. When the ion beam is irradiated, the cutting edge is processed such that argon ions Ar ⁺ blow off the cutting edge burrs and the like against the needle tube 3 on which the first needle tip 5 and the second needle tip 6 are formed. The blade edge is sharply processed (see FIG. 9A).
In this embodiment, the argon gas pressure is, for example, 0.1 to 1.0 Pa, and the voltage condition in the vacuum chamber is, for example, a bias voltage of 0.1 to 1.0 kV, and an ionization voltage. 2.0 to 3.0 kV, the discharge current is 100 to 300 A, and the processing time is set to about 5 to 300 minutes.

When the needle tube 3 is attached to the needle tube fixing base 500 while being held by the holding mechanism 15, the needle tube 3 is arranged with a certain interval (see FIG. 9B). As a method of providing a constant interval, for example, there are a method of arranging a spacer between the needle tubes 3 or affixing in a state of being separated by a predetermined distance when affixing to the adhesive tape 14. Thereby, an ion beam is irradiated with respect to each needle tube 3 at the time of ion beam irradiation. When the needle tube 3 is an injection needle (tapered needle) having an inner diameter and an outer diameter that are maximum at the proximal end and minimum at the distal end and have a portion that gradually decreases from the proximal end side toward the distal end side, Since the holding mechanism 15 holds the base end side where the inner diameter and the outer shape are the maximum, the other end side where the inner diameter and the outer shape are the minimum are arranged with a predetermined interval. In addition, it is not necessary to attach the needle tube 3 to the adhesive tape 14 with a predetermined interval, and more needle tubes 3 can be polished at one time (see FIG. 9B). At this time, for example, when the cutting edge is formed on the distal end side with a tapered needle having a proximal end outer diameter of 0.35 mm and a distal end outer diameter of 0.2 mm, each adjacent adjacent distal end side can be obtained by just aligning the proximal end side. The interval between the needle tubes is about 0.15 mm. In addition, the needle tube fixing base 500 can be configured to uniformly irradiate the needle tube 3 with the ion beam by rotating during the ion beam irradiation.

The shortest interval between the tip portions of adjacent needle tubes at the time of ion beam irradiation may be 0.03 mm or more, preferably 0.06 mm or more, and more preferably 0.12 mm or more. Although an upper limit is not specifically limited, From the point of processing efficiency, it is 5 mm or less, Preferably it is 1 mm or less, More preferably, it is 0.5 mm or less.

In this embodiment, a dry polishing method is preferable, and ion beam irradiation is particularly preferable. Thereby, the burr | flash produced at the time of wire electric discharge machining in a vacuum atmosphere can be melted and vaporized. Thereby, the surface roughness of the needle tube 3 in which the first needle tip 5 and the second needle tip 6 are formed can be improved, and the cutting edge can be sharpened.

<Assembly process>
In the assembly process, the needle tube 3 is fixed to the hub 2 to assemble the needle set. That is, in the assembly process, the first step of inserting the needle tube 3 into the hub 2, the adhesive is applied to the joint between the hub 2 and the needle tube 3, the adhesive is cured, and the needle tube 3 is fixed to the hub 2. A second step, a third step of attaching an appropriate amount of lubricant to the needle tube 3, a fourth step of mounting a detachable cap covering the needle 3 therebetween, on the distal end side of the needle tube 3, and a cap mounted A fifth step of housing the injection needle in a case having an opening and a sixth step of sealing the case by closing the opening of the case with a film. Further, the three steps include a step of applying a lubricant to the needle tube 3 and a step of removing excess lubricant applied to the needle tube 3.

As the first assembly process, the jig 31 shown in FIG. 10 is prepared, and the hub body 23 of the hub 2 is mounted on the tip side of the jig 31 as shown in FIG.

As the second assembly process, as shown in FIG. 11, the needle tube 3 is inserted from the first needle tip 5 into the lumen of the through hole 22 of the hub 2. At this time, the needle tube 3 is inserted until the first needle tip 5 comes into contact with the jig 31, the first needle tip 5 protrudes inside the hub 2, and the second needle tip 6 extends from the hub 2. Projects outward. That is, the first needle tip 5 is located on the proximal end side of the hub 2, and the second needle tip 6 is located on the distal end side of the hub 2. In addition, the direction of the needle tube 3 may be opposite to the above. That is, the second needle tip 6 may be positioned on the proximal end side of the hub 2.

As the third assembly process, as shown in FIG. 12, the adhesive 7 is applied to the joint between the hub 2 and the needle tube 3, for example, the recess 26 of the hub 2, and the adhesive 7 is cured, The needle tube 3 is fixed to the hub 2. The needle tube 3 is fixed to the hub 2 with an adhesive 7 at a position in the middle of the longitudinal direction.

As the fourth assembly step, the jig 32 shown in FIG. 13 is prepared, the injection needle 10 mounted on the jig 31 is removed from the jig 31, and the tip of the jig 32 is removed as shown in FIG. The hub body 23 of the hub 2 of the injection needle 10 is attached to the side.

As a fifth assembly step, an appropriate amount of lubricant is adhered to the second needle tip 6 side of the needle tube 3 of the injection needle 10. In this case, first, a lubricant is applied to the inner periphery and the outer periphery of the needle tube 3 of the injection needle 10 on the second needle tip 6 side. As the lubricant, for example, a silicone liquid (silicone oil) or the like can be used. Next, excess lubricant applied to the needle tube 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

As a sixth assembly step, an appropriate amount of lubricant is adhered to the first needle tip 5 side of the needle tube 3 of the injection needle 10. In this case, first, a lubricant is applied to the inner periphery and the outer periphery of the needle tube 3 of the injection needle 10 on the first needle tip 5 side. As the lubricant, for example, a silicone liquid (silicone oil) or the like can be used. Next, excess lubricant applied to the needle tube 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

As a seventh assembly step, as shown in FIG. 15, a removable cap 41 that covers the needle tube 3 is attached to the small diameter portion 24 on the second tip 6 side of the needle tube 3. The cap 41 has a bottomed cylindrical shape.

As an eighth assembly step, the injection needle 10 with the cap 41 attached is removed from the jig 31, and the injection needle 10 is housed in a case 42 having an opening as shown in FIG.

As the ninth assembly step, as shown in FIG. 15, the opening of the case 42 is closed with a film 43, and the case 42 is sealed.

<Inspection process>
In the inspection process, a predetermined inspection is performed on the injection needle 1. Examples of inspection items include the bending of the needle tube 3, the needle length, the shape of the cutting edge, and the like.

<Packaging process>
In the packaging step, a predetermined number (a plurality) of injection needles 1 are packaged together.

<Sterilization process>
In the sterilization step, the packaged injection needle 1 is sterilized. The sterilization method is not particularly limited, and for example, γ-ray sterilization, EOG sterilization, autoclave sterilization, heat-sensitive sterilization, electron beam sterilization, and the like can be used.

As described above, according to the method for manufacturing the injection needle 1, the injection needle 1 can be manufactured easily and efficiently, productivity can be improved, and the cutting edge can be sharpened. Become.

Particularly, it is possible to easily and efficiently manufacture the injection needle 1 including the needle tube 3 having two or more portions having a relatively small diameter (particularly, inner diameter) and different diameters (particularly, inner diameter).

In the present invention, one or more of the joining process, correction process, inspection process, packaging process, and sterilization process may be omitted.
As mentioned above, although the manufacturing method and injection needle of the injection needle | hook of this invention were demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is arbitrary which has the same function. It can be replaced with that of the configuration. Moreover, other arbitrary components and manufacturing processes may be added to the present invention.
In the above embodiment, the injection needle is used when administering a drug solution, but in the present invention, the use of the injection needle is not limited to this, for example, an indwelling needle, a blood collection needle, etc. It can be applied to various medical uses.

The method for producing an injection needle of the present invention is a method for producing an injection needle used for injecting a chemical solution, and a blade edge forming step of forming an injection needle by forming a blade edge by wire electric discharge machining on at least one end of a needle tube, And a polishing step of performing an ion etching process on the injection needle on which the cutting edge is formed in a vacuum atmosphere.
In addition, the manufacturing method of the injection needle of the present invention is a manufacturing method of an injection needle used for injecting a chemical solution. The cutting edge is formed at least at one end of a needle tube, and the cutting edge is formed. A polishing step in which when the formed injection needle is subjected to an ion etching process, an interval between adjacent needle tubes at the one end is set to at least 0.03 mm.
Moreover, the injection needle of the present invention is manufactured by the method for manufacturing an injection needle of the present invention.
According to the present invention, the injection needle can be manufactured easily and efficiently, and the productivity can be improved. In addition, the cutting edge can be sharpened, and puncture pain and wounds can be reduced. In particular, in the injection needle that forms the cutting edge using wire cutting, the number of steps at the time of manufacture can be reduced, and it can be manufactured easily and efficiently. Therefore, it has industrial applicability.

Claims

In the manufacturing method of the injection needle used to inject the drug solution,
A blade edge forming step of forming a cutting edge by wire electric discharge machining on at least one end of the needle tube, and forming an injection needle;
A polishing step of performing ion etching processing in a vacuum atmosphere on the injection needle on which the cutting edge is formed;
A method for producing an injection needle characterized by comprising:
The polishing step includes
In a vacuum furnace, fix the injection needle on which the cutting edge is formed by a fixture that fixes one end of the needle tube,
2. The method of manufacturing an injection needle according to claim 1, wherein the needle tube including at least the cutting edge is polished by irradiating an ion beam using plasma ions in a vacuum atmosphere.
In the manufacturing method, the needle tube further has an outer diameter on the one end side smaller than an outer diameter on the other end side,
A blade edge is formed in the blade edge forming step on the one end side where at least the outer diameter is small,
The method of manufacturing an injection needle according to claim 2, wherein the other end side is fixed by the fixing tool and the polishing step is performed.
The said injection needle consists of a taper-shaped needle tube whose inner diameter and outer diameter of one end side are larger than the inner diameter and outer diameter of the other end side. Method for producing the injection needle.
The said manufacturing method WHEREIN: Furthermore, the said needle tube has a press process processed into a pipe body by press-molding a strip | belt-shaped metal plate member, The Claim 1 characterized by the above-mentioned. A method for producing an injection needle.
In the manufacturing method of the injection needle used to inject the drug solution,
Forming a cutting edge at least at one end of the needle tube, and forming a cutting edge to form an injection needle;
When performing ion etching processing on the injection needle on which the cutting edge is formed, a polishing step in which the interval between adjacent needle tubes at the one end is at least 0.03 mm;
A method for producing an injection needle characterized by comprising:
The polishing step includes
In a vacuum furnace, fix the injection needle on which the cutting edge is formed by a fixture that fixes one end of the needle tube,
7. The method of manufacturing an injection needle according to claim 6, wherein the needle tube including at least the cutting edge is polished by irradiating an ion beam using plasma ions in a vacuum atmosphere.
An injection needle manufactured by the method for manufacturing an injection needle according to any one of claims 1 to 7.