WO2021241776A1 - Procédé de fabrication d'aiguille d'injection sans douleur et aiguille d'injection sans douleur - Google Patents

Procédé de fabrication d'aiguille d'injection sans douleur et aiguille d'injection sans douleur Download PDF

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Publication number
WO2021241776A1
WO2021241776A1 PCT/KR2020/006874 KR2020006874W WO2021241776A1 WO 2021241776 A1 WO2021241776 A1 WO 2021241776A1 KR 2020006874 W KR2020006874 W KR 2020006874W WO 2021241776 A1 WO2021241776 A1 WO 2021241776A1
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WO
WIPO (PCT)
Prior art keywords
needle
injection needle
painless
manufacturing
painless injection
Prior art date
Application number
PCT/KR2020/006874
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English (en)
Korean (ko)
Inventor
김경도
Original Assignee
주식회사 스핀
김경도
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 주식회사 스핀, 김경도 filed Critical 주식회사 스핀
Priority to PCT/KR2020/006874 priority Critical patent/WO2021241776A1/fr
Publication of WO2021241776A1 publication Critical patent/WO2021241776A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B21G1/08—Making needles used for performing operations of hollow needles or needles with hollow end, e.g. hypodermic needles, larding-needles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
    • B21G—MAKING NEEDLES, PINS OR NAILS OF METAL
    • B21G1/00—Making needles used for performing operations
    • B21G1/12—Securing, cleaning-off burrs, reconditioning polishing, grinding
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D11/00—Electrolytic coating by surface reaction, i.e. forming conversion layers
    • C25D11/02—Anodisation
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D5/00—Electroplating characterised by the process; Pretreatment or after-treatment of workpieces
    • C25D5/10—Electroplating with more than one layer of the same or of different metals
    • C25D5/12—Electroplating with more than one layer of the same or of different metals at least one layer being of nickel or chromium
    • C25D5/14—Electroplating with more than one layer of the same or of different metals at least one layer being of nickel or chromium two or more layers being of nickel or chromium, e.g. duplex or triplex layers
    • C—CHEMISTRY; METALLURGY
    • C25—ELECTROLYTIC OR ELECTROPHORETIC PROCESSES; APPARATUS THEREFOR
    • C25D—PROCESSES FOR THE ELECTROLYTIC OR ELECTROPHORETIC PRODUCTION OF COATINGS; ELECTROFORMING; APPARATUS THEREFOR
    • C25D5/00—Electroplating characterised by the process; Pretreatment or after-treatment of workpieces
    • C25D5/34—Pretreatment of metallic surfaces to be electroplated
    • C25D5/36—Pretreatment of metallic surfaces to be electroplated of iron or steel

Definitions

  • the present invention relates to a painless injection needle manufacturing method and a painless injection needle therefor, and more particularly, a painless injection needle having an outer diameter of 0.2 mm or less in general is manufactured by a progressive stamping die process and a plating process It relates to a method for manufacturing a painless injection needle and to a painless injection needle manufactured thereby.
  • a syringe is a tool used by a nurse or doctor to directly inject a drug into a patient's body.
  • a conventional syringe is provided with one injection needle, and the medicine in the cylinder is injected into the patient by pressing the piston.
  • a painless injection needle (painless injection needle) has been developed and is used for anesthesia of the gums in dentistry.
  • the currently used dental painless injection uses a very fine needle and injects anesthesia into the punctured area without feeling pain.
  • this conventional painless injection needle is welded (S11) to both seams in a state in which a thin and wide flat plate 20 is made into a cylinder 22 having an inner diameter by pressing (S10). was manufactured by bonding, bending correction (S12), electrolytic polishing (S13) processes, and then grinding the ends three times (Grinding) (S14).
  • the sidewall thickness of the needle must be quite thick in order to secure strength enough not to bend the needle when the needle is inserted into the skin.
  • the inner diameter of the injection needle becomes smaller as the side wall thickness is increased inevitably, and accordingly, the flowability of the chemical is deteriorated, thereby increasing the injection time.
  • the present invention has been devised to solve the above problems, and an object of the present invention is to manufacture a painless injection needle by a progressive mold method and a plating method. It is to provide a painless injection needle manufacturing method and a painless injection needle having improved flowability of a chemical solution by increasing the inner diameter as much as the thickness reduced by the forging process while preventing bending during the forging process.
  • Another object of the present invention is to provide a painless injection needle manufacturing method and a painless injection needle which can further increase elasticity and strength by using a high-strength plating material while filling a seam by plating.
  • Another object of the present invention is to provide a painless injection needle manufacturing method that is easy to manufacture by eliminating the conventional process of grinding the tip three times by sharpening the tip before the cylindrical forming process, and a painless injection needle thereof.
  • a painless injection needle manufacturing method for achieving the above object, comprising the steps of: (a) making the tip end of the thin plate to be a sharp plate by primary rough notching to cut the shape from the edge of the plate;
  • step (d) rounding by chamfering the sharp tapered part of the sharp tip cut by the secondary main notching in step (c);
  • step (f) is,
  • it further includes a palladium or cobalt plating process of coating a palladium layer or a cobalt layer again on the surface of the needle coated with the nickel layer after the nickel plating process.
  • the thickness of the nickel plating layer is 0.3 to 5.0 ⁇ m
  • the thickness of the palladium layer or the cobalt layer is 0.03 to 1.0 ⁇ m
  • the thickness of the gold plating layer is 0.03 ⁇ m to 0.5 ⁇ m.
  • the nickel plating process is characterized in that the needle is immersed in the nickel plating solution 6 times.
  • a plate material having a thickness of 0.025 to 0.07 t is forged into a plate material having a thickness of 0.02 to 0.05 t
  • an outer diameter of 0.10 to 0.20 mm and an inner diameter of 0.06 to 0.16 mm are cylindrical needles. It is characterized in that it is molded with
  • Painless injection needle according to an embodiment of the present invention as a painless injection needle manufactured by the above-described method;
  • An injection needle body coupled to the end of the syringe cylinder, an insertion portion having a relatively smaller inner diameter than the inner diameter of the needle body, and a pointed end portion penetrating the skin during injection, so as to be biased to one side, the needle body and An injection needle which is integrally formed between the insertion parts and consists of an intermediate part having a uniformly tapered shape;
  • a needle body coupled to the end of the syringe cylinder, an insertion portion having a relatively smaller inner diameter than the inner diameter of the needle body, and a pointed end portion penetrating the skin during injection, so as to be biased to one side, and the needle body
  • An injection needle formed integrally between the and the insertion part and comprising a middle part having a tapered shape to be biased to one side;
  • An injection needle which is coupled to the end of the syringe cylinder and integrally formed with a middle portion having a uniformly tapered shape, and an insertion portion that is sharply formed so that the tip penetrating the skin during injection is biased to one side;
  • An injection needle which is coupled to the end of the syringe cylinder and integrally formed with a central portion having a tapered shape to be biased to one side, and an insertion portion formed to be sharp so that the tip penetrating the skin during injection is biased to one side;
  • the rear end is coupled to the end of the syringe cylinder and the tip penetrating the skin is biased to one side during injection,
  • It is characterized in that it is any one or more injection needles.
  • the strength of the material is reinforced by the forging process of the progressive mold method, and bending is prevented when inserted into the skin.
  • the inner diameter is increased as much as the reduced thickness, and the flowability of the chemical is improved, thereby exhibiting the effect of shortening the injection time.
  • the 3 times grinding process of the tip part as in the prior art is omitted, so that the manufacturing process is simple and manufacturing is easy.
  • FIG. 1 is a process diagram showing a manufacturing process of a conventional painless injection needle.
  • Figure 2 is a schematic diagram showing a manufacturing process of a conventional painless injection needle.
  • Figure 3 is a process diagram showing the manufacturing process of a painless injection needle according to an embodiment of the present invention.
  • FIG. 4 is a detailed process diagram of the plating process shown in FIG. 3 .
  • FIG. 5 is a schematic diagram showing a manufacturing process of a painless injection needle according to an embodiment of the present invention.
  • 6A and 6B are views showing the primary temporary notching process and the secondary main notching process shown in FIG. 3 .
  • FIG. 7a to 7e are exemplary views of a painless injection needle according to an embodiment of the present invention.
  • Figure 8 is a picture substitute for the painless injection needle manufactured by the embodiment of the present invention.
  • Figure 3 is a process diagram showing a manufacturing process of a painless injection needle according to an embodiment of the present invention
  • Figure 5 is a schematic diagram illustrating a manufacturing process of a painless injection needle according to an embodiment of the present invention.
  • the manufacturing process of the painless injection needle according to the embodiment of the present invention includes notching (S30), forging (S32), chamfering (S34), forming (S36) and plating process (S38) .
  • the manufacturing process of the painless injection needle according to the embodiment of the present invention is first, notching ( Notching) (S30) process is performed to manufacture the plate 52 with a sharp tip.
  • the notching process is an operation of cutting the plate material with a punch in a predetermined contour in the progressive mold, and as shown in FIGS. 6A and 6B, a part of the plate material is sheared several times by the punches 60a and 60b to the plate material 50a, 50b. ) to form the outline of
  • This notching process may be made of primary temporary notching (FIG. 6a) performed before forging and secondary main notching performed after forging (FIG. 6B).
  • the notched plate with a thickness of 0.025 to 0.07 t is forged (Forging) (S32) to make a plate with a thickness of 0.02 to 0.05 t to increase the strength of the material.
  • forging processing is a processing method to make a desired shape by spreading thinly by tapping.
  • the sharp tapered part of the sharp tip cut by the second main notching is chamfered (S34) to round it and round it. Due to such chamfering, there is no sharp edge on the outer peripheral surface of the cylindrically shaped needle by the forming process to be described later, so that the skin tissue is pinched and inserted during the procedure, so that the skin is not cut.
  • the cylindrical needle is filled with a cylindrical needle with nickel (Ni) plating (S38) and the strength is increased once again.
  • the plating refers to thinly coating another material on the surface of an object in order to make the surface state of an object more useful than the properties of the material.
  • the thickness (0.02mm) of the plate is thin, so that the outer diameter is 0.18mm, so that no pain is felt during insertion, but the inner diameter is 0.14mm, so that it is possible to manufacture a needle with good drug flow.
  • the thinnest painless injection needle implemented in the prior art has an outer diameter of 0.18 mm, and in this case, an inner diameter of 0.07 mm, whereas the painless injection needle according to the present invention has an inner diameter of 0.14 mm when the outer diameter is 0.18 mm. Since the inner diameter is about twice larger than that, the flowability of the chemical is very good.
  • Painless injection needle according to the present invention can be implemented up to an outer diameter of 0.10mm, an inner diameter of 0.06mm.
  • FIG. 4 is a detailed process diagram of the plating shown in FIG.
  • the plating process includes degreasing (S40), chemical polishing (S41), nickel strike (S42), nickel plating (S43), palladium or cobalt plating (S44), gold plating (S45), sealing (S46) and a drying step (S47) are included.
  • a number of impurities such as oxides and oils may be adhered to the surface of the needle of the present invention that has undergone the process shown in FIG. A process is required to remove this residue.
  • a degreasing (cleaning) S40 is a process of performing the removal of fats and oils among this residue removal.
  • degreasing consists of ultrasonic degreasing and electrolytic degreasing.
  • the concentration of the degreasing agent is 50-60 g/L and the temperature is 50-60 ° C.
  • electrolytic degreasing the concentration of the degreasing agent is 50-60 g/L, and the temperature is 50 ⁇ 60°C, the current is preferably 20.5 ⁇ 5A
  • Chemical polishing (S41) is polishing to obtain a smooth glossy surface on the surface by immersing the needle that has undergone the degreasing process (S40) in a known chemical polishing solution (solution such as strong acid, strong alkali, or oxidizing agent) for a short time am.
  • a known chemical polishing solution solution such as strong acid, strong alkali, or oxidizing agent
  • the concentration of the chemical abrasive is preferably 60% to undiluted solution (100%).
  • Nickel strike is a plating process used to improve plating adhesion. Usually, when nickel is plated directly on SUS 304 material, adhesion failure occurs due to the passivation film. To prevent this, a thin plating layer with good adhesion is formed as a base plating is a process that
  • the nickel chloride concentration is 180-220 g/L
  • the hydrochloric acid concentration is 80-120 g/L
  • the temperature is room temperature.
  • Nickel plating is to coat a nickel layer on the surface of the needle that has undergone a nickel strike process, and is made by immersing the needle in a nickel plating solution 6 times, and the plating thickness is preferably 0.5 to 5.0 ⁇ m.
  • the nickel sulphamate concentration is 600 ⁇ 850g/L
  • the nickel chloride concentration is 8 ⁇ 15g/L
  • the bong acid concentration is 35 ⁇ 50g/L
  • the additive is 15 ⁇ 30ml/L
  • the additive replenishment period is 380ml/4hr
  • the PH is 4.0-5.0
  • 50-60 degreeC of temperature and 20-25A of current are preferable.
  • Palladium or cobalt plating is a process in which a palladium or cobalt layer is again coated on the surface of the needle coated with a nickel layer, and the needle is immersed in a palladium or cobalt plating solution, and the plating thickness is 0.03um ⁇ 1.0 um is preferable.
  • the palladium or cobalt plating process can be omitted.
  • the palladium concentration is preferably 8-10 g/L
  • the cobalt concentration is 14-18 g/L
  • the PH is 5-7
  • the specific gravity is 10-13Be.
  • Gold plating is a process in which a gold layer is again coated on the surface of a needle coated with a nickel layer, a palladium layer, or a cobalt layer, and the needle is immersed in a gold plating solution once.
  • the plating thickness is 0.025um or more, In particular, 0.03um to 0.5um is preferable.
  • the gold concentration is 4.0 to 6.0 g/L
  • the additive is 10 to 40 ml/L
  • the PH is 4.0 to 5.0
  • the temperature is 50 to 60 ° C
  • the specific gravity is 10 to 15 Be
  • the current is 3 to 5.2 A.
  • Sealing is a process to change various properties such as corrosion resistance by sealing the micropores of the anodized film.
  • the additive eg, SEALING-691
  • SEALING-691 is preferably 10 to 40 ml/L
  • the temperature is preferably 40 to 50 ° C.
  • plating is completed through hot water rinse at 60 ⁇ 70°C and drying process in 90 ⁇ 120°C dryer.
  • the seam is filled by such a plating process containing nickel, and the strength of the needle is further improved by the plating solution.
  • the reason for limiting the thickness of the nickel plating layer to 0.3 ⁇ 5.0um, the thickness of the palladium layer or cobalt layer to 0.03 ⁇ 1.0um, and the thickness of the gold plating layer to 0.03um ⁇ 0.5um is that the plating thickness sufficient to fill the seam to make it happen
  • FIG. 7a to 7e are exemplary views of a painless injection needle according to an embodiment of the present invention.
  • the painless injection needle 100 shown in Figure 7a has an inner diameter 110 and a needle body 102 coupled to the end of the syringe cylinder, and has a relatively smaller inner diameter than the inner diameter of the needle body 102
  • the insertion part 106 which is sharply formed so that the tip 108 penetrating the skin during injection is biased to one side, and the needle body 102 and the insertion part 106 are integrally formed and uniformly tapered It consists of an intermediate part 104 that does.
  • the painless injection needle 100 shown in FIG. 7b has an inner diameter 110 and a needle body 102 coupled to the end of the syringe cylinder, and has a relatively smaller inner diameter than the inner diameter of the needle body 102
  • the insertion part 106 which is sharply formed so that the tip 108 penetrating the skin during injection is biased to one side, and the needle body 102 and the insertion part 106 are integrally formed and taper to one side. It consists of an intermediate part 104 having a true shape.
  • the painless injection needle 100 shown in Fig. 7c is sharp so that the middle portion 104 coupled to the end of the syringe cylinder and having a uniformly tapered shape, and the tip portion 108 penetrating the skin during injection are biased to one side.
  • the insertion portion 106 is formed integrally.
  • the painless injection needle 100 shown in Figure 7d is coupled to the end of the syringe cylinder and has a middle portion 104 having a tapered shape to be biased to one side, and the tip portion 108 that penetrates the skin during injection is biased to one side
  • the insertion part 106 which is formed as sharp as possible is integrally formed.
  • the painless injection needle shown in Fig. 7e is composed of an insertion portion 106 whose end is coupled to the end of the syringe cylinder and is sharply formed so that the tip 108 penetrating the skin during injection is biased to one side.

Abstract

La présente invention concerne un procédé de fabrication d'une aiguille d'injection sans douleur, qui permet la fabrication d'une aiguille d'injection sans douleur ayant un diamètre externe de 0,2 mm ou moins au moyen d'une opération à matrice d'estampage progressif et d'une opération de placage, et concerne également une aiguille d'injection sans douleur fabriquée par le même procédé. Le procédé de fabrication de l'aiguille d'injection sans douleur selon la présente invention consiste : (a) à façonner une extrémité en pointe en plaque pointue par un entaillage provisoire primaire qui découpe la forme à partir du bord d'une plaque mince; (b) à effectuer un traitement de forgeage sur la plaque à entaille provisoire primaire de façon à amincir l'épaisseur de la plaque et, en même temps, augmenter la résistance par écrouissage; (c) à effectuer un entaillage principal secondaire qui découpe la forme à partir de la zone agrandie par le traitement de forgeage de l'étape (b) à une dimension d'origine; (d) à chanfreiner une partie effilée acérée de l'extrémité en pointe acérée découpée par l'entaillage principal secondaire à l'étape (c), et à l'arrondir; et (e) à façonner la plaque chanfreinée en une forme cylindrique.
PCT/KR2020/006874 2020-05-28 2020-05-28 Procédé de fabrication d'aiguille d'injection sans douleur et aiguille d'injection sans douleur WO2021241776A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/KR2020/006874 WO2021241776A1 (fr) 2020-05-28 2020-05-28 Procédé de fabrication d'aiguille d'injection sans douleur et aiguille d'injection sans douleur

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/KR2020/006874 WO2021241776A1 (fr) 2020-05-28 2020-05-28 Procédé de fabrication d'aiguille d'injection sans douleur et aiguille d'injection sans douleur

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WO2021241776A1 true WO2021241776A1 (fr) 2021-12-02

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001054573A (ja) * 1999-08-18 2001-02-27 Kawasumi Lab Inc 医療用針及びその製造方法
US20110160612A1 (en) * 2009-12-28 2011-06-30 Stanley Kim Pain free hypodermic needle
KR20130114620A (ko) * 2012-04-09 2013-10-18 연세대학교 산학협력단 망막하 주사 또는 추출용 중공형 마이크로니들 및 망막하 주사기
JP2015147042A (ja) * 2014-01-08 2015-08-20 ニプロ株式会社 中空針および中空針の製造方法
JP2019166290A (ja) * 2018-03-21 2019-10-03 敬 冷牟田 無痛注射針
KR102165489B1 (ko) * 2019-02-18 2020-11-05 주식회사 케이바이오미라클니들 무통 주사바늘 제조방법 및 그 무통 주사바늘

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001054573A (ja) * 1999-08-18 2001-02-27 Kawasumi Lab Inc 医療用針及びその製造方法
US20110160612A1 (en) * 2009-12-28 2011-06-30 Stanley Kim Pain free hypodermic needle
KR20130114620A (ko) * 2012-04-09 2013-10-18 연세대학교 산학협력단 망막하 주사 또는 추출용 중공형 마이크로니들 및 망막하 주사기
JP2015147042A (ja) * 2014-01-08 2015-08-20 ニプロ株式会社 中空針および中空針の製造方法
JP2019166290A (ja) * 2018-03-21 2019-10-03 敬 冷牟田 無痛注射針
KR102165489B1 (ko) * 2019-02-18 2020-11-05 주식회사 케이바이오미라클니들 무통 주사바늘 제조방법 및 그 무통 주사바늘

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