JP2007054194A - Production method of injection needle assembly and injection needle assembly - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a production method of an injection needle assembly and an injection needle assembly with a higher productivity by enabling the easier and efficient production of the injection needle assemblies. <P>SOLUTION: The production method of the injection needle assembly has: a reception process for receiving a strip of plate material made of a metal onto a press molding machine; a press molding process in which the plate material undergoes a continuous press molding with the press molding machine to obtain a plurality of pipe bodies each partially linked to the plate material; a bonding process for bonding the seam parts of the individual pipe bodies by welding or with an adhesive; a correction process for correcting the shapes of the individual pipe bodies so that the pipe bodies are made almost straight in the center axis, a separation process for separating the individual bodies off the plate material; an edging process in which a cutting edge (cutting face) is formed at least at each one end of the pipe bodies to form injection needles separately; a washing process for washing the injection needles and an assembling process for fixing each injection needle on a hub to make injection needle assemblies separately. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

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

  2. Description of the Related Art A needle assembly is known in which a needle is fixed to a hub. When manufacturing a small-diameter metal tube used for the injection needle of this needle assembly, conventionally, the metal thin plate is pulled out while being rolled, and the end face of the thin plate is joined before entering the drawing die. After welding and drawing with a drawing die as it is to form a tubular body having an outer diameter of about 4 to 6 mm, the drawing is further repeated to form a tubular body with a desired outer diameter.

  And the injection needle is manufactured by grinding the front-end | tip part of this tubular body, and forming a blade (for example, refer patent document 1).

  The injection needle manufactured in this way is fixed to the hub, and the injection needle assembly is assembled.

  However, such a conventional manufacturing method cannot efficiently manufacture the needle assembly.

Japanese Patent Publication No. 61-28472

  An object of the present invention is to provide a method for manufacturing a needle assembly and a needle assembly that can be manufactured easily and efficiently, and that are highly productive.

Such an object is achieved by the present inventions (1) to (26) below.
(1) a receiving process of receiving a metal plate material in a belt shape into a press molding machine;
A press molding step of continuously pressing the plate material by the press molding machine to obtain a plurality of pipes partially connected to the plate material;
A separation step of separating the tubular body from the plate material;
A blade attaching step of forming a blade at at least one end of the tubular body to form an injection needle;
An assembly process for assembling an injection needle assembly by fixing the injection needle to a hub.

  (2) In the press molding step, a direction substantially perpendicular to the longitudinal direction of the plate material is the longitudinal direction of the tube body, and the plurality of tube bodies are arranged in parallel along the longitudinal direction of the plate material. The manufacturing method of the injection needle assembly as described in said (1).

(3) The press forming step is a first step of punching out from the plate material a developed shape body that has a shape obtained by developing the tubular body in a state where a part thereof is connected to the plate material;
The injection needle according to (1) or (2), further including a second step of bending the developed shape body at least once using a convex shape and a concave shape and forming the tubular shape to obtain the tubular body. Manufacturing method of assembly.

  (4) In the separation step, the pipes are temporarily fixed substantially simultaneously with the separation of the tubular bodies or after the separation of the tubular bodies, and the positional relationship between the tubular bodies is maintained. (3) The manufacturing method of the injection needle assembly in any one of.

  (5) The method for manufacturing an injection needle assembly according to (4), wherein an interval between the temporarily fixed adjacent tube bodies is smaller than an interval between adjacent tube bodies partially connected to the plate member.

  (6) The method of manufacturing an injection needle assembly according to (4) or (5), wherein the temporary fixing is performed by attaching at least one location excluding the central portion in the longitudinal direction of the tubular body to an adhesive tape.

  (7) In the said blade attachment process, the manufacturing method of the injection needle assembly as described in said (6) which forms a blade in the site | part which is not affixed on the said adhesive tape of the said tubular body.

  (8) In the blade attaching step, the plurality of tubes are held at a substantially central portion in the longitudinal direction of the tubes, and the positional relationship between the tubes is maintained (1) to (7). The manufacturing method of the injection needle assembly in any one.

  (9) The blade attachment process according to any one of (1) to (8), wherein in the state of maintaining the positional relationship between the tubes, blades are simultaneously formed on the plurality of tubes. A method of manufacturing a needle assembly.

  (10) The injection needle is a double-ended needle, and in the assembly step, the injection needle is fixed to the hub at a position in the middle of the injection needle in the longitudinal direction. The manufacturing method of the injection needle assembly in any one.

  (11) The method for manufacturing an injection needle assembly according to any one of (1) to (10), wherein a lubricant is attached to the injection needle in the assembly step.

(12) The assembly step includes a first step of inserting the injection needle into the hub;
A second step of applying an adhesive to a joint between the hub and the injection needle, curing the adhesive, and fixing the injection needle to the hub;
The method of manufacturing a needle assembly according to any one of (1) to (10), further including a third step of attaching an appropriate amount of lubricant to the needle.

(13) The third step in the assembly step includes a step of applying a lubricant to the injection needle;
The method for producing a needle assembly according to (12), further comprising a step of removing excess lubricant applied to the needle.

(14) The assembly step includes, after the third step, a fourth step of attaching a removable cap that covers the injection needle to the distal end side of the injection needle,
A fifth step of storing the assembly to which the cap is attached in a case having an opening;
The manufacturing method of the injection needle assembly according to (12) or (13), further including a sixth step of closing the opening of the case with a film and sealing the case.

  (15) The above (1) to (14), further comprising a correcting step of correcting the shape of the tubular body so that a central axis of the tubular body is substantially straight between the press forming step and the separating step. A method for manufacturing the needle assembly according to any one of the above.

  (16) The method according to any one of (1) to (14), further including a joining step of bonding a joint portion of the pipe body by welding or an adhesive between the press molding step and the separation step. A method of manufacturing a needle assembly.

  (17) The injection needle according to (16), further including a correcting step of correcting the shape of the tubular body so that a central axis of the tubular body is substantially straight between the joining step and the separating step. Manufacturing method of assembly.

  (18) The method for manufacturing an injection needle assembly according to any one of (1) to (17), further including a cleaning step of cleaning the injection needle between the blade attaching step and the assembly step.

(19) After the assembly process, an inspection process for inspecting the injection needle assembly;
A packaging step of packaging a predetermined number of the needle assembly together;
The method of manufacturing a needle assembly according to any one of (1) to (18), further comprising a sterilization step of sterilizing the packaged needle assembly.

  (20) The manufacturing method of the injection needle assembly according to any one of (1) to (19), wherein the injection needle has two or more portions having different inner diameters.

  (21) The manufacturing method of the injection needle assembly according to (20), wherein the injection needle has a minimum inner diameter of 2 mm or less and a maximum inner diameter of 5 mm or less.

(22) The inner diameter and the outer diameter on one end side of the injection needle are larger than the inner diameter and the outer diameter on the other end side, respectively.
In the assembling step, the injection needle set according to (20) or (21), wherein the injection needle is fixed to the hub such that the one end side of the injection needle is positioned on the proximal end side of the hub. Solid manufacturing method.

(23) The inner diameter and the outer diameter on one end side of the injection needle are smaller than the inner diameter and the outer diameter on the other end side, respectively.
In the assembling step, the injection needle set according to (20) or (21), wherein the injection needle is fixed to the hub such that the one end side of the injection needle is positioned on the proximal end side of the hub. Solid manufacturing method.

  (24) The method of manufacturing an injection needle assembly according to any one of (1) to (19), wherein an inner diameter of the injection needle is 2 mm or less.

  (25) The method of manufacturing an injection needle assembly according to any one of (1) to (24), wherein the maximum height difference (Rf) of the surface roughness of the inner surface of the injection needle is 3 μm or less.

  (26) A needle assembly manufactured by the method for manufacturing a needle assembly according to any one of (1) to (25).

  According to the present invention, an injection needle assembly can be manufactured easily and efficiently, and productivity can be improved.

  In particular, it is possible to easily and efficiently manufacture an injection needle assembly including an injection needle having two or more portions having relatively small diameters (particularly inner diameters) and different diameters (particularly inner diameters).

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

  FIG. 1 is a cross-sectional view showing an embodiment of the injection needle assembly of the present invention, and FIG. 2 is a vertical cross-sectional view showing the configuration of a metering dispenser used by mounting the injection needle assembly shown in FIG. .

  For convenience of explanation, in FIGS. 1 and 2, the left side in the figure is referred to as “tip” and the right side is referred to as “base end”.

  Before describing the embodiment of the method of manufacturing the needle assembly of the present invention, first, the embodiment of the needle assembly manufactured by the method of manufacturing the needle assembly will be described.

  As shown in FIG. 1, an injection needle assembly (liquid guide) 1 includes a metal injection needle (hollow needle) 3 and a hub (cap holder) 2 to which the injection needle 3 is fixed (fixed). Have. In the present embodiment, the injection needle 3 is bonded to the hub 2 with an adhesive 7.

  The injection needle assembly 1 is attached to and detached from a distal end portion of a quantitative dispenser disclosed in, for example, Japanese Patent Application Laid-Open No. 9-225031 or a prefilled syringe (medical solution storage device) in which a chemical solution is stored (contained) in advance. Used freely. Hereinafter, the case where the injection needle assembly 1 is used by being attached to a quantitative dispenser will be described as an example.

  As shown in FIG. 2, the metering dispenser 100 uses a cartridge 400 containing a chemical solution 300 in a syringe body 200.

  Examples of the drug solution 300 include insulin (insulin preparation), vitamin (general vitamin), various amino acids, antithrombotic agents such as heparin, antibiotics, antitumor agents, analgesics, cardiotonic agents, intravenous anesthetics, anti Examples include Parkinson's agent, ulcer treatment agent, corticosteroid agent, arrhythmia agent, correction electrolyte and the like.

  The cartridge 400 includes a cylindrical cartridge main body 410, a gasket 420, and a connection portion 430. The cartridge body 410 has a bottom 411 at one end and an opening at the other end.

  The outer diameter of the cartridge main body 410 is substantially the same as the inner diameter of the syringe main body 200, and the gasket 420 is inserted into the inner cavity of the cartridge main body 410 so that the gasket 420 can slide in a liquid-tight manner.

  A space 440 defined by the gasket 420 and the inner wall of the cartridge body 410 is filled with the chemical solution 300 as described above. A connection portion 430 is provided on the bottom 411 of the cartridge body 410.

  As shown in FIG. 2, the connection portion 430 has a hole 412 formed in the bottom 411 of the cartridge body 410, a storage portion 432 provided on the opening side of the hole 412, and a liquid-tight storage in the storage portion 432. The plug body 431 is provided.

  The storage portion 432 is formed between the protrusions 433 and 434 formed at predetermined intervals on the inner wall of the hole 412.

  The plug 431 is made of, for example, natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane-based, polyester-based, polyamide-based, olefin-based, styrene-based various thermoplastic elastomers, Alternatively, a mixture thereof can be used. Moreover, the plug body 431 may be configured by a multilayer structure.

  On the other hand, the syringe body 200 that houses the cartridge 400 is formed with an insertion port 210 for inserting the cartridge 400 into the distal end portion. A groove 220 is formed in the inner peripheral surface of the insertion port 210 in the circumferential direction, and a mounting portion for mounting the holder lid 230 is configured by the groove 220.

The holder lid 230 is formed of a bottomed cylindrical member having an opening 231 at one end.
A protrusion 232 continuously formed in the circumferential direction is provided on the outer peripheral surface of the opening 231 of the holder lid 230, and a fitting portion is configured by the protrusion 232.

Further, on the outer peripheral surface on the bottom side of the holder lid 230, a screw groove 234 into which a screw thread 21 formed on the inner peripheral surface of the hub 2 of the injection needle assembly 1 to be described later is screwed is formed.
A hole 233 is formed in the center of the bottom of the holder lid 230.

  By screwing the hub 2 into the holder lid 230, the injection needle assembly 1 is attached to the distal end portion of the metering dispenser 100.

  In a state where the injection needle assembly 1 is mounted on the metering dispenser 100, the proximal end portion (first needle tip 5) of the injection needle 3 pierces the plug 431. Thereby, the inside and outside of the metering dispenser 100 communicate with each other via the lumen portion of the injection needle 3. And the chemical | medical solution 300 can be discharged | emitted from the inside of the fixed amount dispenser 100 by pressing the plunger 500 of the fixed amount dispenser 100 and moving the gasket 420 to a front-end | tip direction.

  The hub 2 of the injection needle assembly 1 is formed on a hub body 23 having a bottomed cylindrical shape, and on the distal end side and the proximal end side of the bottom portion of the hub body 23, and the outer diameter thereof is larger than the outer diameter of the hub body 23. It is composed of small small diameter portions 24 and 25.

  On the inner peripheral surface of the hub main body 23, a thread 21 that is screwed into the thread groove 202 of the mouth portion 201 is formed. 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 injection needle 3 is inserted (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 injection needle 3 is fixed to the hub 2 at a position in the middle of the longitudinal direction.

  The method for fixing the injection needle 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 injection needle 3 is a double-ended needle, and includes a needle body 4, a sharp first needle tip 5 provided at one end (base end) of the needle body 4, and the needle body 4. It has a sharp second needle tip 6 provided at the end (tip) (the side opposite to the first needle tip 5), and these are formed integrally.

  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 injection needle 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 injection needle 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 injection needle 3 is used by being pierced through the plug 431 of the quantitative dispenser 100 described above, while the second needle tip 6 is used for a living body (for example, a blood vessel, subcutaneous skin, etc.). Used by puncturing.

  The first needle tip 5 is shaped like a tubular member cut obliquely. That is, the first needle tip 5 is formed with a distal end surface 51 that is inclined with respect to the central axis of the injection needle 3. A blade (blade surface) is preferably formed on the tip surface 51. Thereby, the piercing resistance in the front-end | tip part 52 of the 1st needle tip 5 can be reduced, and the piercing of the plug 431 becomes easier.

  Further, the second needle tip 6 has a shape that is obtained by cutting a tubular member obliquely. That is, a tip surface 61 that is inclined with respect to the central axis of the injection needle 3 is formed on the second needle tip 6. Since this injection needle 3 is used by puncturing the living body with the second needle tip 6, it is preferable that a blade (blade surface) is formed on the distal end surface 61 thereof. Thereby, a patient's pain can be reduced more.

  In the injection needle assembly 1, a blade is formed on at least one of the first needle tip 5 and the second needle tip 6.

  Further, in the injection needle 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.

  The injection needle 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 (diameter) and outer diameter (diameter) of the injection needle 3 are maximum at the proximal end and smallest at the distal end, and gradually decrease from the proximal end side toward the distal end side (toward the distal end direction). is doing. That is, the inner diameter and the outer diameter of the proximal end (one end side) of the injection needle 3 are larger than the inner diameter and the outer diameter of the distal end (the other end side), and the injection needle 3 has an end portion with the larger inner diameter and outer diameter. It is fixed to the hub 2 so that (one end side) is located on the base end side of the hub 2.

  With such a configuration, the second needle tip 6 that is punctured into the living body is secured while ensuring a sufficient volume of the internal flow path (lumen portion) of the injection needle 3 as compared with an injection needle having a constant inner diameter and outer diameter. It is possible to prevent the outer diameter from increasing. For this reason, in the injection needle 3, the outstanding effect that the pain with respect to a patient can be reduced is exhibited, preventing the passage resistance of the chemical | medical solution 300 increasing.

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

  The outermost diameter of the injection needle 3 that is the maximum outer diameter of the injection needle 3, that is, the outer diameter of the root of the first needle tip 5 (diameter φ1 in FIG. 1) is 6 mm or less. Preferably, it is about 0.3 to 0.6 mm, more preferably about 0.35 to 0.6 mm.

  The inner diameter of the most proximal end of the injection needle 3 that is the maximum inner diameter of the injection needle 3, that is, the inner diameter of the root portion of the first needle tip 5 (diameter φ2 in FIG. 1) is preferably 5 mm or less. More preferably, it is about 2 to 0.5 mm, and further 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 of the injection needle 3, which is the minimum outer diameter of the injection needle 3, that is, the outer diameter of the root of the second needle tip 6 (diameter φ3 in FIG. 1) is 3 mm or less. Is preferably 0.3 mm or less, more preferably about 0.1 to 0.25 mm, and particularly preferably about 0.1 to 0.22 mm.

  The inner diameter of the injection needle 3 that is the minimum inner diameter of the injection needle 3, that is, the inner diameter of the root of the second needle tip 6 (diameter φ4 in FIG. 1) is preferably 2 mm or less. It is more preferably about 05 to 0.15 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.

  Moreover, the maximum height difference (Rf) of the surface roughness according to JIS-B-0601-1994 of the inner surface of the injection needle 3 is preferably 3 μm, more preferably 2 μm or less, and 1 μm or less. Is more preferable, and about 0.1 to 1 μm is particularly preferable.

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

  In the present invention, for example, the inner diameter and the outer diameter of the proximal end (one end side) of the injection needle 3 are smaller than the inner diameter and the outer diameter of the distal end (the other end side). May be fixed to the hub 2 such that the smaller end portion (one end side) is located on the proximal end side of the hub 2.

In the present invention, the shape and structure of the injection needle 3 are not limited to those described above, and may be, for example, the following ones, or two or more of the above-described ones or the following ones. Any combination may be used.
(1) A sharp needle tip and a blade are not formed at one end of the injection needle, and a sharp needle tip and a blade are provided only at the other end.
(2) A sharp needle tip is formed at one end of the injection needle, but no blade is formed, and only the other end has a sharp needle tip and a blade. .
(3) All inner diameters are constant. In this case, the inner diameter (diameter) is preferably 2 mm or less, more preferably about 0.1 to 1.5 mm, and further preferably about 0.1 to 1.0 mm.
(4) A part having a part with a constant inner diameter.
(5) It has two or more parts with different inner diameters, and at least one of the two or more parts has a predetermined length along the longitudinal direction.
(6) A part having a part where the inner diameter gradually decreases from the proximal side toward the distal side (toward the distal direction).
(7) The inner diameter is the largest at the proximal end and the smallest at the distal end, and has a portion that gradually decreases from the proximal end side toward the distal end side.
(8) A part having a part where the inner diameter gradually increases from the proximal side toward the distal side (toward the distal direction).
(9) The inner diameter is the smallest at the proximal end and the largest at the distal end, and gradually increases from the proximal end side toward the distal end side.
(10) A part having a part where the inner diameter is the smallest at the proximal end and the largest at the distal end and gradually increases from the proximal end side toward the distal end side.
(11) The inner diameter of the base end (one end side) is smaller than the inner diameter of the tip end (the other end side).

Hereinafter, two other configuration examples (embodiments) of the injection needle 3 (injection needle assembly 1) will be described.
3 is a cross-sectional view showing another embodiment of the injection needle assembly of the present invention, and FIG. 4 is an enlarged side view showing a first needle tip of the injection needle of the injection needle assembly shown in FIG. FIG. 5 is a front view of the first needle tip shown in FIG.

  FIG. 4 is shown opposite to FIG. For convenience of explanation, in FIG. 3, the left side in the figure is referred to as “tip”, the right side is referred to as “base end”, and the left side in FIG.

  Moreover, in the following description, it demonstrates centering around difference with the injection needle 3 (injection needle assembly 1) shown in FIG. 1 mentioned above, and the description is abbreviate | omitted about the same matter.

  In the injection needle 3, the central axis thereof is substantially straight at the second needle tip 6 and the needle body 4, and is curved or bent at the first needle tip 5.

  The needle body 4 has a portion in which the inner diameter and the outer diameter gradually decrease in the distal direction near the center thereof, and the inner diameter and the outer diameter are substantially constant in portions other than the portion. As a result, the injection needle 3 has an inner diameter and an outer diameter on the second needle tip 6 side that are smaller than an inner diameter and an outer diameter on the first needle tip 5 side.

  With such a configuration, it is possible to prevent an increase in the outer diameter of the second needle tip 6 that is punctured into the living body, while ensuring a sufficient volume of the internal flow path (lumen portion) of the injection needle 3. it can. For this reason, in the injection needle 3, the outstanding effect that the pain with respect to a patient can be reduced is exhibited, preventing the passage resistance of the chemical | medical solution 300 increasing.

From this point of view, the dimensions of each part of the injection needle 3 are set as follows, for example.
The outer diameter of the needle body 4 that is the maximum outer diameter of the injection needle 3 on the first needle tip 5 side, that is, the root outer diameter of the first needle tip 5 (diameter φ1 in FIG. 3) is 6 mm or less. Preferably, it is about 0.3 to 0.6 mm, more preferably about 0.35 to 0.6 mm.

  The inner diameter on the first needle tip 5 side of the needle body 4 that is the maximum inner diameter of the injection needle 3, that is, the inner diameter at the base of the first needle tip 5 (diameter φ2 in FIG. 3) is 5 mm or less. Preferably, it is about 0.2 to 0.5 mm, and more preferably about 0.25 to 0.5 mm.

  The length of the first needle tip 5 (length L1 in FIG. 3) 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 outer diameter of the needle body 4 that is the minimum outer diameter of the injection needle 3 on the second needle tip 6 side, that is, the root portion outer diameter (diameter φ3 in FIG. 3) of the second needle tip 6 is 3 mm. It is preferably not more than 0.3 mm, more preferably not more than 0.3 mm, still more preferably about 0.1 to 0.25 mm, and particularly preferably about 0.1 to 0.22 mm.

  The inner diameter of the needle body 4 that is the minimum inner diameter of the injection needle 3 on the second needle tip 6 side, that is, the inner diameter of the root portion of the second needle tip 6 (diameter φ4 in FIG. 3) is 2 mm or less. Preferably, it is about 0.05 to 0.15 mm, more preferably about 0.05 to 0.1 mm.

  The length of the second needle tip 6 (length L2 in FIG. 3) 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.

  Note that the maximum height difference (Rf) of the surface roughness according to JIS-B-0601-1994 and the constituent materials of the inner surface of the injection needle 3 are the same as those of the injection needle 3 described above.

  This injection needle 3 is characterized by the shape of the first needle tip 5. Hereinafter, this point (feature) will be described with reference to FIG.

  The tip surface 51 of the first needle tip 5 shown in FIG. 4 is concave on the side of the central axis O (hereinafter simply referred to as “central axis O”) of the needle body 4 in the vicinity of the root portion (the jaw portion). A concave curved surface 511 is provided.

  Since the distal end surface 51 has the concave curved surface 511, the angle formed between the tangent at the proximal end of the concave curved surface 511 and the central axis O in the rising at the proximal end of the distal end surface 51, that is, in a side view of the first needle tip 5. (An angle θ1 in FIG. 4) can be set sufficiently large.

  Thus, by setting the angle θ1 to be large, when the first needle tip 5 is pierced through the plug body 431, the plug body 431 is prevented from being cut in the vicinity of the root portion (base end portion). That is, it is possible to prevent the piercing portion from being cut out in a columnar shape around the entire circumference of the first needle tip 5.

  Thereby, it can prevent that the part cut out by the column shape of the plug body 431 is blocked by the lumen | bore part of a needle point (generation | occurrence | production of a coring).

  Further, in the injection needle 3, the first needle tip 5 has an acute angle (angle α in FIG. 4) between the center line C and the center axis O of the tip 52, and as shown in FIG. When viewed from a longitudinal section (cross section shown in FIG. 4) passing through the distal end 53 when the distal end 53 is inward of the outer shape of the needle body 4, the root 53 side (upper side in FIG. 4) of the distal end surface 51 from the central axis O. In the portion where the concave curved surface 511 is provided, the portion is bent or curved.

  First, the first needle tip 5 is bent or curved at a portion where the concave curved surface 511 is provided, so that the first needle tip 5 is deformed so that the first needle tip 5 projects laterally at the bent portion or the curved portion. Can be prevented. That is, as shown in FIG. 5, the outer shape of the first needle tip 5 in front view can be made substantially circular. Thereby, when the plug body 431 is punctured by the first needle tip 5, it is possible to prevent the occurrence of catching.

  Further, when the center line C and the center axis O of the distal end portion 52 form an acute angle, the first needle tip 5 opens sideways (upward in the drawing). As described above, the first needle tip 5 opens sideways, that is, does not open at the tip, so that the generation of the coring as described above can be prevented more reliably.

  In the injection needle 3, the distal end 53 of the first needle tip 5 is located on the inner side of the outer shape of the needle body 4 in a front view and on the distal end surface 51 from the central axis O when viewed in a longitudinal section passing through the distal end 53. It is located on the root side.

  As a result, when the plug 431 is punctured with the first needle tip 5 side of the injection needle 3, the distal end portion 52 of the first needle tip 5 punctures the plug 431 and is opposite to the distal end surface 51 of the distal end portion 52. The side surface 54 (the lower surface in FIGS. 4 and 5) presses the surface of the plug body 431, and a recess is formed on the surface of the plug body 431. As a result, the puncture site of the plug 431 by the distal end portion 52 of the first needle tip 5 is gradually pushed and spread, and the injection needle 3 pierces the plug 431.

  Thus, in the injection needle 3, the root portion of the concave curved surface 511 (the tip surface 51 of the first needle tip 5) is prevented or suppressed from strongly contacting (contacting) the surface of the plug 431. Regardless of the hardness of the plug 431, the occurrence of coring can be reliably prevented.

  In addition, on the surface of the plug body 431 pierced by the injection needle 3, an arc-shaped scratch is formed around the penetration mark.

  Further, when the injection needle 3 is pierced through a bromobutyl rubber sheet having a hardness of 45 degrees (thickness 2 mm) at a puncture angle of 90 °, the length of the scratch is less than twice the outer diameter of the needle body 4. Preferably, it is 1.5 times or less, more preferably 1 time or less. When the injection needle 3 satisfies such conditions, the above-described effect is exhibited more remarkably.

  The angle θ1 is not particularly limited, but is preferably about 45 to 90 °, and more preferably about 60 to 90 °. If the angle θ1 is too small, the effect of preventing the occurrence of coring may not be sufficiently exerted. On the other hand, if the angle θ1 is too large, when the first needle tip 5 pierces the plug, It tends to be easily caught on the plug in the vicinity of the root.

  The curvature radius (average) of the concave curved surface 511 is not particularly limited, but is preferably about 0.05 to 0.3 mm, and more preferably about 0.05 to 0.2 mm. If the radius of curvature (average) of the concave curved surface 511 is too small, the effect of preventing the occurrence of coring is reduced. On the other hand, if the radius of curvature (average) of the concave curved surface 511 is too large, the angle θ1 may be increased. It may become difficult and the effect of preventing the occurrence of coring may not be sufficiently exhibited.

  The angle α is not particularly limited, but is preferably about 10 to 60 °, and more preferably about 30 to 45 °. If the angle α is too small, the length of the first needle tip 5 becomes unnecessarily large, and the strength may be lowered depending on the constituent material and the like. On the other hand, if the angle α is too large, the first There is a possibility that it will be difficult to pierce the plug with the needle tip 5 of the needle.

  Further, the distal end portion of the distal end surface 51 has a flat surface 512 that is continuous with the concave curved surface 511 and is inclined with respect to the central axis O. When the front end surface 51 has the flat surface 512, it becomes easy to form the concave curved surface 511 so that the function of the concave curved surface 511 can be suitably demonstrated.

  The angle formed by the flat surface 512 and the central axis O (angle θ2 in FIG. 4) is not particularly limited, but is preferably 45 ° or less, more preferably about 10 to 30 °. By setting the angle θ2 in the above range, the concave curved surface 511 can be easily and reliably formed in a desired shape.

  In addition, the root portion of the first needle tip 5 is configured not to protrude outward from the outer peripheral surface of the injection needle 3 (needle body 4) closest to the base end side from the root portion. Thereby, when the plug body 431 is pierced with the first needle tip 5, it is possible to prevent the hook body 431 from being caught in the vicinity of the root portion.

  Note that a blade (blade surface) is formed on the distal end portion of the distal end surface 51 of the first needle tip 5 of the injection needle 3 (for example, the distal end portion of the flat surface 512 or the concave curved surface 511). Is preferred. Thereby, the piercing resistance in the front-end | tip part 52 of the 1st needle tip 5 can be reduced, and the piercing of the plug 431 becomes easier.

Next, another configuration example (embodiment) of the injection needle 3 (injection needle assembly 1) will be described.
FIG. 6 is an enlarged side view showing a first needle tip of an injection needle in another embodiment of the injection needle assembly of the present invention.

  For convenience of explanation, in FIG. 6, the left side in the drawing is described as “base end” and the right side is described as “tip”.

  Moreover, in the following description, it demonstrates centering around difference with the injection needle 3 (injection needle assembly 1) shown in FIG. 3 mentioned above, The description is abbreviate | omitted about the same matter.

  In the injection needle 3 shown in FIG. 6, the central axis O is substantially in a straight line 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.

  The first needle tip 5 is formed with a tip surface 51 that is inclined with respect to the central axis of the injection needle 3. A blade (blade surface) is preferably formed on the tip surface 51. Thereby, the piercing resistance in the front-end | tip part 52 of the 1st needle tip 5 can be reduced, and the piercing of the plug 431 becomes easier.

  The first needle tip 5 of the injection needle 3 has a distal end surface 51 continuous with a concave curved surface 511 that is recessed toward the central axis O in the vicinity of the root portion (ago portion), and a concave curved surface 511 at the distal end portion. And a flat surface 512. Thereby, generation | occurrence | production of a coring can be prevented.

  The flat surface 512 is inclined with respect to the central axis O, and the base end thereof is continuous with the concave curved surface 511. Since the distal end surface 51 has such a flat surface 512, the piercing resistance of the first needle tip 5 can be further reduced, and the function of the concave curved surface 511 can be suitably achieved. It becomes easy to form the concave curved surface 511.

  The angle between the flat surface 512 and the central axis O (angle θ2 in FIG. 6) is not particularly limited, but is preferably 30 ° or less, and more preferably about 10 to 30 °. By setting the angle θ2 in the above range, the above-described effects can be further improved. If the angle θ2 is too large, the piercing resistance of the first needle tip 5 is increased, which is not preferable.

  Note that a blade (blade surface) is formed on the distal end portion of the distal end surface 51 of the first needle tip 5 of the injection needle 3 (for example, the distal end portion of the flat surface 512 or the concave curved surface 511). Is preferred. Thereby, the piercing resistance in the front-end | tip part 52 of the 1st needle tip 5 can be reduced, and the piercing of the plug 431 becomes easier.

  The piercing resistance of the first needle tip 5 is preferably as small as possible. Specifically, the following is preferable.

  That is, a silicone rubber sheet having a thickness of 0.5 mm is prepared as a puncture body, and the first needle tip 5 is inserted through the puncture body at a puncture angle of 90 ° and a puncture speed of 10 mm / min. At this time, the maximum load of puncture resistance to the puncture body of the first needle tip 5 is preferably 35 gf or less, more preferably about 5 to 30 gf, and further about 20 to 30 gf. preferable. If the maximum load of the piercing resistance of the first needle tip 5 is within the above range, the plug 431 can be pierced satisfactorily by the first needle tip 5.

  Next, an embodiment of the manufacturing method of the injection needle assembly of the present invention, that is, a manufacturing method of the injection needle assembly 1 shown in FIG. 1 will be described.

  FIG. 7 is a process diagram showing an embodiment of a method for manufacturing a needle assembly according to the present invention, and FIGS. 8 to 11 are diagrams showing press forming steps of the method for manufacturing the needle assembly shown in FIG. 12 is a view showing a separation step of the method for manufacturing the injection needle assembly shown in FIG. 7, and FIG. 13 is a view showing a blade attaching step of the method for manufacturing the injection needle assembly shown in FIG. Moreover, FIG.13 (b) is sectional drawing in the AA line in Fig.13 (a).

  In particular, in FIGS. 8 to 11, the unfolded shape body and the tube body are described with the diameter of the tube body being exaggerated to be larger than the actual diameter.

  As shown in FIG. 7, the manufacturing method of the injection needle assembly 1 includes a receiving step of receiving a metal plate material in a band shape into a press molding machine, and the press molding machine continuously press-molds the plate material. A press forming step of obtaining a plurality of pipes partially connected to the plate material, a joining step of bonding the joints of the pipes by welding or an adhesive, and the central axis of the pipes being substantially straight A correction step for correcting the shape of the tubular body, a separation step for separating the tubular body from the plate material, a blade (blade surface) is formed on at least one end of the tubular body, and an injection needle A blade attaching step for forming the needle, a washing step for washing the injection needle, an assembly step for fixing the injection needle to the hub and assembling the injection needle assembly, and an inspection step for inspecting the injection needle assembly, A package for packaging a predetermined number of the needle assembly A step, and a sterilization step of sterilizing the packaged needle assembly. Hereinafter, each of these steps will be described sequentially.

[1] Receiving process A strip-shaped metal plate is received in 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 above-mentioned as a constituent material of a board | plate material, metal materials, such as stainless steel, aluminum, or an aluminum alloy, titanium, or a titanium alloy, are mentioned, for example.

[2] Press molding process The press molding process is a first process in which a press molding machine is used to punch out a developed shape body in a shape in which a tubular body is unfolded from a plate material in a state where a part is connected to the plate material, and a press molding machine. And a second step of bending the developed shape body at least once using a convex shape and a concave shape, forming the tubular shape into a tubular shape, and obtaining a tubular body partially connected to the plate material. As shown in FIG. 11, in this embodiment, the tubular body 9 has an inner diameter (diameter) and an outer diameter (diameter) that are maximum at one end and minimum at the other end, and extend from the one end to the other end. Gradually decreasing.

  In the present embodiment, as the press molding machine, a punched portion (not shown) that mechanically punches out a developed shape body 81 having a shape in which the tubular body 9 is developed from the plate material 8 in a state of being partially connected to the plate material 8, The unfolded shape 81 punched out by the part is bent by the first bent part 11 using the concave mold (mold) 111 and the convex mold (mold) 112, and is bent by the first bent part 11. A second bent portion 12 for further bending the developed shape body 81 using a concave mold (mold) 121 and a convex mold (mold) 122, and the developed shape body 81 curved by the second bent portion 12. Is bent further using a pair of concave molds (molds) 131 and 132 having a shape corresponding to the outer shape of the tube body 9, and has a third bent portion 13 that is formed into a tubular shape (the shape of the tube body 9). A continuous press molding machine is used (see FIGS. 8 to 11).

  In this press molding step, first, as shown in FIG. 8, the portion of the plate member 8 where the developed shape body 81 is punched is disposed at the position of the punched portion, and the punched portion causes the plate member 8 to 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. 9, the unfolded moving body 81 is moved along the longitudinal direction of the plate member 8 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 curved 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 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. 10, the unfolded moving body 81 is moved by the first bending portion 11 by moving the plate 8 along the longitudinal direction with respect to the press molding machine by a moving mechanism (not shown). 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. 11, 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 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 drawing, 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 bending portion 13 is located between the concave mold 131 and the concave mold 132 (inside the concave molds 131 and 32), and has a core (not shown) having a shape corresponding to the inner shape of the tubular body 9. It may be arranged so that the core is positioned in the inner cavity of the tube body 9, and the developed shape body 81 may be pressed and bent to be formed into a tubular shape.

  In the present invention, the number of bending portions of the press molding machine, that is, the number of times of press working using different dies before obtaining the tubular body 9 from the developed shape body 81 is not limited to 3 times, but 2 times. The following may be sufficient, and four times or more may be sufficient.

  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.

[3] Joining Step In the joining step, the joint 83 (see FIG. 11) 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, it is inexpensive and Carbon dioxide laser welding or YAG laser welding suitable for fine processing is particularly preferable.

[4] Correction process In the correction process, the shape of each tube 9 is corrected so that the central axis of each tube 9 is substantially straight.

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.

[5] Separation process In the separation process, each tubular 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.

  Further, 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 this embodiment, the temporary fixing is performed by attaching both end portions of the tube body 9 to a pair of adhesive tapes (temporary fixing members) 14 as shown in FIG. 12 (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.

[6] Blade attaching step In the blade attaching step, a blade (blade surface) is formed on at least one end of each tubular body 9 to form a needle tip, thereby obtaining (forming) an injection needle. 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.

  Here, in this 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. 13, a pair of adhesive tapes 14 is provided by a holding mechanism 15 having a pair of long gripping portions (holding portions) 151 that grips (holds) a substantially central portion of each tubular 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 side in FIG. 13 (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. 13B). . Thereby, each adhesive tape 14 is removed from the injection needle 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, for example, wire cut processing such as wire cut electric discharge machining, grinding processing, cutting Among them, wire cut machining (particularly wire cut electric discharge machining) is preferable. 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 injection needle 3 is fixed to the hub 2, the second needle tip 6 may be formed by forming a tip surface 61 having a blade at the other end.

  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.

[7] Washing Step In the washing step, the injection needle 3 on which the first needle tip 5 and the second needle tip 6 are formed is washed.

  The method for cleaning the injection needle 3 is not particularly limited, and for example, electrolytic polishing, chemical polishing, or the like can be used.

[8] Assembly Process In the assembly process, the injection needle assembly 1 is assembled by fixing the injection needle 3 to the hub 2. That is, in the assembly process, the first step of inserting the injection needle 3 into the hub 2, the adhesive is applied to the joint between the hub 2 and the injection needle 3, the adhesive is cured, and the injection needle 3 is moved to the hub. A second step of fixing to the injection needle 3, a third step of attaching an appropriate amount of lubricant to the injection needle 3, and a fourth step of attaching a removable cap covering the injection needle 3 to the distal end side of the injection needle 3. And a fifth step of housing the assembly with the cap 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 injection needle 3 and a step of removing excess lubricant applied to the injection needle 3.

  Hereinafter, two different methods, that is, a first assembly process and a second assembly process will be specifically described for this assembly process. In addition, the numbers of the first process to the sixth process and the first process to the eighth process in the first assembly process and the second assembly process described later do not necessarily correspond to each other.

[8-1] First Assembly Step FIGS. 14 to 20 are views showing a first assembly step of the method of manufacturing the injection needle assembly shown in FIG. 14A is a cross-sectional view, FIG. 14B is a plan view, FIG. 17A is a cross-sectional view, and FIG. 17B is a plan view.

  15, 16, 18, and 19, the upper side in the drawing is “tip”, the lower side is “base”, and the upper side in FIG. 20 is “base” in FIG. The lower side will be described as a “tip”.

<First step>
A jig 31 shown in FIG. 14 is prepared. As shown in FIG. 15, the hub body 23 of the hub 2 is mounted on the tip side of the jig 31.

<Second step>
As shown in FIG. 15, the injection needle 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 injection needle 3 is inserted until the first needle tip 5 contacts the jig 31, the first needle tip 5 protrudes inside the hub 2, and the second needle tip 6 is inserted into the hub 2. Protrudes outside. 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 the present invention, the direction of the injection needle 3 may be reversed. That is, the second needle tip 6 may be positioned on the proximal end side of the hub 2.

<Third step>
As shown in FIG. 16, the adhesive 7 is applied to the joint between the hub 2 and the injection needle 3, for example, the concave portion 26 of the hub 2, and the adhesive 7 is cured, and the injection needle 3 is attached to the hub 2. Fix it. The injection needle 3 is fixed to the hub 2 with an adhesive 7 at a position in the middle of the longitudinal direction.

<4th process>
A jig 32 shown in FIG. 17 is prepared, the assembly 10 mounted on the jig 31 is removed from the jig 31, and the hub of the assembly 10 is placed on the tip side of the jig 32 as shown in FIG. 2 hub body 23 is mounted.

<5th process>
An appropriate amount of lubricant is adhered to the second needle tip 6 side of the injection needle 3 of the assembly 10.

  In this case, first, a lubricant is applied to the inner circumference and the outer circumference of the injection needle 3 of the assembly 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 injection needle 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

<6th process>
An appropriate amount of lubricant is adhered to the first needle tip 5 side of the injection needle 3 of the assembly 10.

  In this case, first, a lubricant is applied to the inner periphery and the outer periphery of the injection needle 3 of the assembly 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 injection needle 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

<Seventh step>
As shown in FIG. 19, a detachable cap 41 that covers the injection needle 3 is attached to the small diameter portion 24 on the second tip 6 side of the injection needle 3. The cap 41 has a bottomed cylindrical shape.

<Eighth process>
The assembly 10 to which the cap 41 is attached is removed from the jig 31, and the assembly 10 is stored in a case 42 having an opening, as shown in FIG.

<9th process>
As shown in FIG. 20, the opening of the case 42 is closed with a film 43, and the case 42 is sealed.

[8-2] Second Assembly Step FIGS. 21 to 24 are views showing a second assembly step of the method for manufacturing the injection needle assembly shown in FIG.

  For convenience of explanation, in FIGS. 22 to 24, the upper side in the figure is described as “tip” and the lower side is described as “base end”.

<First step>
Jigs 33 and 34 shown in FIG. 21 are prepared, and as shown in FIG. 22, the jig 33 is mounted on the tip side of the jig 34 and assembled. Then, the hub body 23 of the hub 2 is mounted on the tip side of the jig 33.

<Second step>
As shown in FIG. 22, the injection needle 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 injection needle 3 is inserted until the first needle tip 5 contacts the jig 34, the first needle tip 5 protrudes inside the hub 2, and the second needle tip 6 is inserted into the hub 2. Protrudes outside. 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 the present invention, the direction of the injection needle 3 may be reversed. That is, the second needle tip 6 may be positioned on the proximal end side of the hub 2.

<Third step>
As shown in FIG. 23, the adhesive 7 is applied to the joint between the hub 2 and the injection needle 3, for example, the recess 26 of the hub 2, and the adhesive 7 is cured, so that the injection needle 3 is attached to the hub 2. Fix it. The injection needle 3 is fixed to the hub 2 with an adhesive 7 at a position in the middle of the longitudinal direction.

<4th process>
As shown in FIG. 24, the jig 34 is removed from the jig 33.

<5th process>
An appropriate amount of lubricant is adhered to the first needle tip 5 side of the injection needle 3 of the assembly 10.

  In this case, first, a lubricant is applied to the inner periphery and the outer periphery of the injection needle 3 of the assembly 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 injection needle 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

<6th process>
An appropriate amount of lubricant is adhered to the second needle tip 6 side of the injection needle 3 of the assembly 10.

  In this case, first, a lubricant is applied to the inner circumference and the outer circumference of the injection needle 3 of the assembly 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 injection needle 3 is removed. As a method for removing the lubricant, for example, a method of blowing air or the like can be used.

<Seventh step>
A detachable cap 41 that covers the injection needle 3 is attached to the small diameter portion 24 on the second tip 6 side of the injection needle 3 (see FIG. 19). The cap 41 has a bottomed cylindrical shape.

<Eighth process>
The assembly 10 to which the cap 41 is attached is removed from the jig 33, and the assembly 10 is stored in a case 42 having an opening (see FIG. 20).

<9th process>
The opening of the case 42 is closed with a film 43, and the case 42 is sealed (see FIG. 20).

[9] Inspection process In the inspection process, the needle assembly 1 is subjected to a predetermined inspection. As inspection items, for example, the bending of the injection needle 3, the length of the needle, the shape of the cutting edge, and the like can be mentioned.

[10] Packaging process In the packaging process, a predetermined number (plural) of needle assemblies 1 are packaged together.

[11] Sterilization process In the sterilization process, the packaged needle assembly 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 of manufacturing the injection needle assembly 1, the injection needle assembly 1 can be manufactured easily and efficiently, and productivity can be improved.

  In particular, the injection needle assembly 1 including the injection needle 3 having two or more portions having relatively small diameters (particularly inner diameters) and different diameters (particularly inner diameters) can be manufactured easily and efficiently.

  In the present invention, one or more of the joining process, the correcting process, the cleaning process, the inspection process, the packaging process, and the sterilization process may be omitted.

  As mentioned above, although the manufacturing method of the injection needle assembly and the injection needle assembly of this invention were demonstrated based on embodiment of illustration, this invention is not limited to this, The structure of each part is the same function Can be replaced with any structure having Moreover, other arbitrary structures and processes may be added to the present invention.

It is sectional drawing which shows embodiment of the injection needle assembly of this invention. It is a longitudinal cross-sectional view which shows the structure of the fixed volume dispenser which mounts | wears and uses the injection needle assembly shown in FIG. It is sectional drawing which shows other embodiment of the injection needle assembly of this invention. It is a side view which expands and shows the 1st needle tip of the injection needle of the injection needle assembly shown in FIG. It is a front view of the 1st needlepoint shown in FIG. It is a side view which expands and shows the 1st needle | hook tip of the injection needle in other embodiment of the injection needle assembly of this invention. It is process drawing which shows embodiment of the manufacturing method of the injection needle assembly of this invention. It is a figure which shows the press molding process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the press molding process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the press molding process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the press molding process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the isolation | separation process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the blade attachment process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 1st assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 2nd assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 2nd assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 2nd assembly process of the manufacturing method of the injection needle assembly shown in FIG. It is a figure which shows the 2nd assembly process of the manufacturing method of the injection needle assembly shown in FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Injection needle assembly 2 Hub 21 Thread 22 Through-hole 23 Hub main body 24, 25 Small diameter part 26 Recessed part 3 Injection needle 4 Needle main body 5 1st needle tip 51 Tip surface 511 Concave curved surface 512 Flat surface 52 Tip part 53 Tip 54 Surface 6 Second needle tip 61 Tip surface 7 Adhesive 8 Plate material 81 Expanded shape body 82 Connection portion 83 Joint 9 Tubing body 10 Assembly 11 First bent portion 111 Concave die 112 Convex shape 12 Second bent portion 121 Concave die 122 Convex type 13 Third bent part 131, 132 Concave type 14 Adhesive tape 15 Holding mechanism 151, 152 Grip part 31-34 Jig 41 Cap 42 Case 43 Film 100 Metering dispenser 200 Syringe body 201 Portion 210 Insertion port 220 Groove 230 Holder lid 231 Opening 232 Protrusion 233 Hole 234 Screw groove 300 Chemical solution 400 Cartridge 10 the cartridge body 411 bottom 412 hole 420 gasket 430 connection portion 431 stopper 432 accommodating portion 433 projecting 440 space 500 plunger O center axis C centerline

Claims (10)

An acceptance process for receiving a metal plate material in a belt shape into a press molding machine;
A press molding step of continuously pressing the plate material by the press molding machine to obtain a plurality of pipes partially connected to the plate material;
A separation step of separating the tubular body from the plate material;
A blade attaching step of forming a blade at at least one end of the tubular body to form an injection needle;
An assembly process for assembling an injection needle assembly by fixing the injection needle to a hub.   2. The injection needle according to claim 1, wherein in the separation step, the tubes are temporarily fixed substantially simultaneously with the separation of the tubes or after the separation of the tubes, and the positional relationship between the tubes is maintained. Manufacturing method of assembly.   The injection needle assembly according to claim 1 or 2, wherein the injection needle is a double-ended needle, and in the assembly step, the injection needle is fixed to the hub at a position midway in the longitudinal direction of the injection needle. Manufacturing method. The assembly step includes a first step of inserting the injection needle into the hub;
A second step of applying an adhesive to a joint between the hub and the injection needle, curing the adhesive, and fixing the injection needle to the hub;
The method for manufacturing a syringe needle assembly according to any one of claims 1 to 3, further comprising a third step of attaching an appropriate amount of lubricant to the syringe needle. The assembly step includes, after the third step, a fourth step of attaching a removable cap that covers the injection needle to the distal end side of the injection needle;
A fifth step of storing the assembly to which the cap is attached in a case having an opening;
The method of manufacturing a syringe needle assembly according to claim 4, further comprising a sixth step of sealing the case by closing the opening of the case with a film.   The correction process according to any one of claims 1 to 5, further comprising a correction process for correcting a shape of the tubular body between the press molding process and the separation process so that a central axis of the tubular body is substantially straight. A method of manufacturing a needle assembly.   The injection needle assembly manufacturing method according to any one of claims 1 to 6, further comprising a joining step of bonding a joint portion of the tube body by welding or an adhesive between the press molding step and the separation step. Method. An inspection step of inspecting the needle assembly after the assembly step;
A packaging step of packaging a predetermined number of the needle assembly together;
The method of manufacturing a needle assembly according to any one of claims 1 to 7, further comprising a sterilization step of sterilizing the packaged needle assembly. The injection needle has two or more parts having different inner diameters, the minimum inner diameter is 2 mm or less, the maximum inner diameter is 5 mm or less,
The inner diameter and outer diameter on one end side of the injection needle are larger than the inner diameter and outer diameter on the other end side, respectively.
9. The syringe needle assembly according to claim 1, wherein, in the assembly step, the syringe needle is fixed to the hub such that the one end side of the syringe needle is located on the base end side of the hub. Solid manufacturing method. An injection needle assembly manufactured by the method for manufacturing an injection needle assembly according to any one of claims 1 to 9.

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