WO2012098767A1 - 針付きシリンジ及び針付きシリンジの製造方法 - Google Patents
針付きシリンジ及び針付きシリンジの製造方法 Download PDFInfo
- Publication number
- WO2012098767A1 WO2012098767A1 PCT/JP2011/077220 JP2011077220W WO2012098767A1 WO 2012098767 A1 WO2012098767 A1 WO 2012098767A1 JP 2011077220 W JP2011077220 W JP 2011077220W WO 2012098767 A1 WO2012098767 A1 WO 2012098767A1
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- WO
- WIPO (PCT)
- Prior art keywords
- syringe
- needle
- needle tube
- fixing
- fixing portion
- Prior art date
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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
- A61M5/32—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
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/343—Connection of needle cannula to needle hub, or directly to syringe nozzle without a needle hub
-
- 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
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14467—Joining articles or parts of a single article
- B29C45/14491—Injecting material between coaxial articles, e.g. between a core and an outside sleeve for making a roll
-
- 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
- A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
- A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
-
- 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
- A61M2207/00—Methods of manufacture, assembly or production
-
- 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
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- 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
- A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
- A61M5/349—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using adhesive bond or glues
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
- B29C45/14598—Coating tubular articles
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T29/00—Metal working
- Y10T29/49—Method of mechanical manufacture
- Y10T29/49826—Assembling or joining
Definitions
- the present invention relates to a syringe with a needle in which a needle tube and a syringe are integrally formed by molding without using an adhesive and a method for producing the syringe with a needle.
- a syringe with a needle is composed of a needle tube having a needle tip that can puncture a living body at the tip, and a needle hub that holds the needle tube with the needle tip of the needle tube protruding.
- hook is comprised by connecting a syringe to a needle hub.
- the needle tube is fixed to the needle hub using an adhesive while being inserted into the insertion hole of the needle hub (see, for example, Patent Document 1).
- a syringe with a needle has been proposed in which the needle hub is eliminated and the needle tube is directly fixed to a syringe filled with a medicine. Also in this syringe with a needle, it is fixed to the syringe using an adhesive as in the conventional syringe with a needle.
- the split direction of the mold is complicated in order not to damage the needle tube.
- a mold having a complicated structure is required, there is a problem that a process for manufacturing a syringe with a needle becomes complicated.
- An object of the present invention is to provide a syringe with a needle and a method for manufacturing a syringe with a needle that can integrally form a needle tube and a syringe by molding without using an adhesive in consideration of the above problems.
- a syringe with a needle of the present invention is formed continuously from a needle tube having a needle tip that can be punctured into a living body, a main body filled with a medicine, and the main body. And a syringe having a fixing portion for fixing the needle tube in a state where the needle tip of the needle tube is protruded, and a connection portion for connecting the fixing portion and the main body.
- the connecting portion of the syringe is provided with a holding hole that holds the proximal end portion of the needle tube opposite to the needle tip. Then, after inserting the proximal end portion of the needle tube into the holding hole, the needle tube is fixed to the fixed portion by forming at least a part of the fixed portion with a resin made of substantially the same material as the syringe.
- the method for manufacturing a syringe with a needle of the present invention includes the following steps (1) to (3).
- the proximal end portion of the needle tube is inserted into the holding hole of the syringe, thereby supporting the needle tube and injecting resin to form a part of the fixing portion.
- the needle tube and syringe are fixed. For this reason, it is not necessary to provide a support portion for supporting the needle tube in the mold forming the syringe, so that the dead volume can be reduced.
- the needle tube can be fixed without using an adhesive.
- resin is the material substantially the same as a syringe, favorable bondability can be obtained.
- FIG. 1 It is a perspective view showing the 1st example of an embodiment of the syringe with a needle of the present invention. It is a perspective view which shows the principal part of 1st Embodiment of the syringe with a needle
- FIG. 10A shows a syringe according to a third embodiment of the syringe with a needle of the present invention
- FIG. 10A is a side view of the syringe
- FIG. 10B is a cross-sectional view taken along the line DD shown in FIG. 10A
- FIG. 11A is a side view of a syringe with a needle
- FIG. 11B is a cross-sectional view taken along line FF shown in FIG. 11A, illustrating a state in which a needle tube is fixed in a third embodiment of a syringe with a needle of the present invention. .
- FIG. 1 is a perspective view showing a syringe with a needle of this example
- FIG. 2 is a perspective view showing a main part of the syringe with a needle of this example.
- FIG. 3 is a cross-sectional view showing an outer cylinder of the syringe with needle of this example.
- 4 is a cross-sectional view showing a state in which a needle tube is attached to the outer cylinder
- FIG. 5 is a cross-sectional view showing a state in which resin is injected into the outer cylinder.
- the syringe with needle 1 is used to puncture the needle tip from the surface of the skin and inject the drug into the living body.
- the syringe with needle 1 has a syringe 2 filled with a medicine and a needle tube 3 fixed to the syringe 2.
- the cap 4 (refer FIG.6 and FIG.7) is mounted
- the needle tube 3 uses a standard of ISO medical needle tube (ISO9626: 1991 / Amd.1: 2001 (E)) having a size of 10 to 33 gauge (outer diameter: ⁇ 3.5 to 0.2 mm), A 16 to 33 gauge (outer diameter: ⁇ 1.7 to 0.2 mm) is preferably used.
- a blade surface for making the needle tip 3a an acute angle is formed at one end of the needle tube 3 in the axial direction. Then, the needle tip 3a on one side in the axial direction of the needle tube 3 is punctured into the living body.
- the material of the needle tube 3 examples include stainless steel, but are not limited thereto, and aluminum, aluminum alloy, titanium, titanium alloy, and other metals can be used.
- the needle tube 3 can be not only a straight needle but also a tapered needle having at least a part tapered.
- the proximal end portion has a larger diameter than the end portion of the needle tip 3a, and the intermediate portion may have a taper structure.
- the cross-sectional shape of the needle tube 3 may be not only a circle but also a polygon such as a triangle.
- a coating agent made of, for example, a silicone resin or a fluorine resin is applied to the surface of the needle tube 3 on the needle tip 3a side.
- the needle tube 3 is fixed to the syringe 2 with the needle tip 3a protruding outward. And as shown in FIG. 4, the needle tip 3a of the axial direction one side of the needle tube 3 protrudes from the front-end
- the syringe 2 includes a main body 6 filled with a medicine and a fixing portion 7 continuous with the main body 6.
- a connecting portion 12 is provided between the main body 6 and the fixing portion 7.
- the main body 6 is formed in a substantially cylindrical shape, and a fixing portion 7 is continuously formed on one side of the main body 6 in the axial direction, and the other end in the axial direction is opened.
- the cylindrical hole 6a of the main body 6 is filled with a medicine, and a pusher gasket is plugged from the other side of the main body 6 in the axial direction.
- the shape of the main body 6 of the syringe 2 in the substantially cylindrical shape was demonstrated in this example, the shape of the main body 6 may be a hollow square column shape or a hexagonal column shape.
- the fixing portion 7 protrudes along the axial direction from one side of the main body 6 in the axial direction.
- the fixing portion 7 has a connecting portion 8 that is continuous from one end of the main body 6 in the axial direction, and a distal end portion 9 that is continuous from the connecting portion 8.
- the fixing portion 7 is provided with an insertion hole 10 that is opened from the distal end portion 9 to the main body 6. The needle tube 3 is inserted into the insertion hole 10 along the axial direction.
- the diameter of the opening of the insertion hole 10 is set sufficiently larger than the diameter of the needle tube 3 so as to be compatible with needle tubes 3 of various thicknesses. Further, the insertion hole 10 may be formed in a tapered shape so that the diameter increases from the main body toward the distal end portion 9. As a result, the needle tube 3 can be easily inserted into the insertion hole 10, and the assembling work can be simplified.
- the shape of the insertion hole 10 can be appropriately set according to the shape of the needle tube 3.
- a holding hole 13 is formed in the connecting portion 12 that is continuous with the insertion hole 10 and connects the fixing portion 7 and the main body 6.
- the holding hole 13 is opened in a substantially cylindrical shape on the main body 6 side, and a proximal end portion 3b which is the other end in the axial direction of the needle tube 3 is inserted (see FIG. 4). Then, by inserting the proximal end portion 3 b of the needle tube 3 into the holding hole 13, the needle tube 3 is supported, and the cylindrical hole 6 a of the main body 6 and the needle tube 3 communicate with each other through the holding hole 13.
- the holding hole 13 is opened in a tapered shape so that the diameter thereof continuously increases as the fixed portion 7 side moves toward one side in the axial direction. As a result, the proximal end portion 3b of the needle tube 3 can be easily inserted into the holding hole 13, and the needle tube 3 having various thicknesses can be supported.
- the connecting portion 8 is formed in a cross shape in a cross-section in a direction orthogonal to the axial direction of the main body 6. Further, the diameter of the connecting portion 8 on the distal end portion 9 side is smaller than the outer diameter of the distal end portion 9. Therefore, the fixed part 7 has a shape in which the connection part between the connecting part 8 and the tip part 9 is constricted.
- the connection part 8 is formed so that it may become thin as it leaves
- the connecting portion 8 is formed with an injection hole 11 indicating an example of an injection portion penetrating from the peripheral surface to the insertion hole 10.
- the injection hole 11 is provided on the main body 6 side from the axial center of the connecting portion 8 rather than the distal end portion 9 side.
- the resin 15 is injected into the injection hole 11 and the insertion hole 10. Then, the resin 15 is filled between the needle tube 3 inserted into the insertion hole 10 and the insertion hole 10, whereby the remaining part of the fixing portion 7 is formed, and the needle tube 3 is attached to the fixing portion 7 of the syringe 2. Fixed.
- Resin 15 is made of substantially the same material as syringe 2. Therefore, it is possible to obtain good bondability with respect to the syringe 2 and firmly fix the needle tube 3 to the syringe 2. Moreover, it is hard to leave a mark in the opening of the insertion hole 10 or the injection hole 11, and the aesthetic appearance of the syringe 2 can be improved.
- the shape of the connecting portion 8 may be a substantially cylindrical shape, a quadrangular prism shape, or a hexagonal prism shape.
- a distal end portion 9 is provided at one end of the connecting portion 8 in the axial direction, that is, at the distal end side of the fixed portion 7.
- the tip portion 9 is formed in a substantially cylindrical shape.
- the outer peripheral surface of the tip portion 9 is in close contact with the inner peripheral surface of the cap 4 described later.
- tip part 9 is a shape corresponding to the shape of the cylinder hole 4a of the cap 4, it will be a square pillar shape or hexagonal note shape. There may be.
- Examples of the material of the syringe 2 having the above-described structure include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, and acrylonitrile-butadiene-styrene.
- Examples thereof include various resins such as polymers, polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12).
- a resin such as polypropylene, cyclic polyolefin, polyester, or poly- (4-methylpentene-1).
- the material of the syringe 2 is substantially transparent in order to ensure internal visibility.
- the drug filled in the syringe 2 may be any drug that is normally used as an injection.
- protein drugs such as antibodies, peptide drugs such as hormones, nucleic acid drugs, cell drugs, blood products, various drugs Vaccines to prevent infectious diseases, anticancer agents, anesthetics, narcotics, antibiotics, steroids, proteolytic enzyme inhibitors, sugar injection solutions such as heparin and glucose, and electrolyte correction injections such as sodium chloride and potassium lactate Liquids, vitamins, fat emulsions, contrast agents, stimulants and the like.
- protein drugs such as antibodies, peptide drugs such as hormones, nucleic acid drugs, cell drugs, blood products, various drugs Vaccines to prevent infectious diseases, anticancer agents, anesthetics, narcotics, antibiotics, steroids, proteolytic enzyme inhibitors, sugar injection solutions such as heparin and glucose, and electrolyte correction injections such as sodium chloride and potassium lactate Liquids, vitamins, fat emulsion
- FIG. 6 is a perspective view showing a state where the cap 4 is attached to the syringe 1 with a needle
- FIG. 6 is a cross-sectional view showing the syringe 1 with a needle 1 and the cap 4 shown in FIG.
- the cap 4 is formed in a substantially cylindrical shape, and one end in the axial direction is open and the other end in the axial direction is closed.
- the cap 4 is formed of an elastic member such as rubber or elastomer.
- the cap 4 is attached to one side in the axial direction of the syringe 2 so as to cover the needle tip 3 a of the needle tube 3 and the fixing portion 7 of the syringe 2. Then, as shown in FIG. 7, the needle tip 3 a side of the needle tube 3 and the fixing portion 7 are inserted into the cylindrical hole 4 a of the cap 4.
- the inner diameter of the cylindrical hole 4a of the cap 4 is set to be approximately equal to or slightly smaller than the outer diameter of the tip 9 of the fixed portion 7. Therefore, when the cap 4 is attached to the syringe 2, the outer peripheral surface of the distal end portion 9 in the fixing portion 7 is in close contact with the inner peripheral surface of the cap 4. As a result, the needle tip 3 a side of the needle tube 3 that is the distal end side from the distal end portion 9 of the fixing portion 7 is sealed by the distal end portion 9 and the inner peripheral surface of the cap 4. As a result, bacteria can be prevented from adhering to the needle tip 3a.
- the inner peripheral surface of the cap 4 tightens the constricted portion and the connection portion between the tip portion 9 and the connecting portion 8 in the fixing portion 7 by its elastic force. Thereby, the inner peripheral surface of the cap 4 and the constricted portion of the fixing portion 7 are engaged, and the cap 4 can be prevented from being detached from the syringe 2 during conveyance.
- the syringe 2 is molded by a mold.
- the needle tube 3 is inserted into the insertion hole 10 of the fixing portion 7 in the syringe 2, and the proximal end portion 3 b of the needle tube 3 is inserted into the holding hole 13.
- the opening on the distal end portion 9 side in the holding hole 13 is formed in a taper shape, the proximal end portion 3b of the needle tube 3 can be easily inserted into the holding hole 13, and the assembly of the syringe 1 with the needle can be easily performed. It can be carried out. Thereby, the needle tube 3 is held by the syringe 2.
- the needle tube 3 can be easily inserted into the holding hole 13. Further, by forming the main body 6 separately from the needle tube 3 and supporting the needle tube 3 with the holding hole 13, it is not necessary to provide a portion for supporting the needle tube 3 on the core pin that forms the cylindrical hole 6a when the main body 6 is formed. . As a result, the dead volume of the cylindrical hole 6a can be reduced as compared with the conventional syringe with a needle that forms the needle tube and the syringe at the same time, and the remaining amount of the drug can be reduced.
- a resin 15 made of substantially the same material as the syringe 2 is injected between the needle tube 3 and the insertion hole 10 through the injection hole 11 provided in the fixing portion 7 to form a part of the fixing portion 7. Moreover, since the syringe 2 and the resin 15 are formed of substantially the same material, good bondability can be obtained. Then, the resin 15 is solidified, so that the remaining part of the fixing portion 7 is formed, the needle tube 3 can be firmly fixed to the syringe 2, and the assembly of the syringe 1 with the needle is completed.
- the injection operation of the resin 15 is performed in a state where a high pressure is applied to the resin 15 in order to fill the insertion hole 10 with the resin 15 without any gap. Therefore, pressure generated when the resin 15 is injected is applied to the syringe 2. Therefore, by working with the syringe 2 placed in the mold, it is possible to prevent the syringe 2 from being deformed by the pressure generated when the resin 15 is injected. Moreover, since the resin 15 can be filled in the insertion hole 10 of the syringe 2 without excess or deficiency, the aesthetic appearance of the syringe 1 with a needle can be improved.
- the injection hole 11 is formed closer to the main body 6 side than the distal end portion 9 side from the axial center of the connecting portion 8. Therefore, the resin 15 can be reliably distributed to the base end 3 b side of the needle tube 3, and the root of the needle tube 3 can be firmly fixed to the syringe 2. Furthermore, since the resin 15 is filled up to the injection hole 11, no trace of the injection hole 11 is left on the side surface of the connecting portion 8, so that the appearance of the needle-equipped syringe 1 can be improved.
- the needle tube 3 is fixed to the syringe 2, so that the needle can be used without using an adhesive.
- the attached syringe 1 can be assembled. Therefore, not only can the bonding process using the adhesive be omitted, but also no adhesive is used, so that there is no possibility that the adhesive will contact the drug filled in the syringe 2 and have an adverse effect.
- FIGS. 8 and 9 are perspective views showing the main part of a syringe with a needle according to the second embodiment.
- the difference between the syringe with needle 21 according to the second embodiment and the syringe with needle 1 according to the first embodiment is a configuration for fixing the fixing portion and the needle tube. Therefore, here, the fixing portion will be described, and the same reference numerals are assigned to the portions common to the syringe 1 with a needle, and redundant description will be omitted.
- the syringe 22 includes a main body 26 filled with a medicine and a fixing portion 27 continuous with the main body 26.
- a connection portion 32 is provided between the main body 26 and the fixing portion 27.
- fixed part 27 before fixing the needle tube 3 is lacking substantially half along the axial direction.
- the needle tube 3 is supported by the syringe 22 by inserting the proximal end portion 3 b into the holding hole 33 provided in the connection portion 32. Then, as shown in FIG. 9, the needle tube 3 is fixed to the syringe 22 by forming a defect portion of the fixing portion 27 using a resin 35 made of substantially the same material as the syringe 22.
- the present invention is not limited to this, and one third of the fixing portion 27 is missing in the axial direction. Also good.
- all of the fixing portion 27 is missing, and after the proximal end portion 3b of the needle tube 3 is inserted into the holding hole 33, the entire fixing portion 27 is molded using a resin made of substantially the same material as the syringe 22. May be. That is, it is only necessary that the proximal end portion 3 b of the needle tube 3 can be inserted into the holding hole 33 of the connection portion 32 in a state where the fixing portion 27 is missing.
- FIG.10 and FIG.11 is explanatory drawing which shows the principal part of the syringe with a needle concerning 3rd Embodiment.
- the difference between the syringe 41 with a needle according to the third embodiment and the syringe 1 with a needle according to the first embodiment is that the injection portion is configured as a groove. Therefore, here, the fixing portion will be described, and the same reference numerals are assigned to the portions common to the syringe 1 with a needle, and redundant description will be omitted.
- the fixing portion 47 of the syringe 42 has a connecting portion 48 that is continuous from one end of the main body 46 in the axial direction, and a tip portion 49 that is continuous from the connecting portion 48.
- the fixing portion 47 is provided with an insertion hole 50 that opens from the distal end portion 49 to the main body 46.
- the needle tube 3 is inserted into the insertion hole 50 along the axial direction.
- An injection groove 51 showing another example of the injection part is formed in the connecting part 48 and the tip part 49.
- the injection groove 51 is a notch that penetrates from the peripheral surface of the connecting portion 48 and the tip portion 49 to the insertion hole 50 and is continuously formed from the connecting portion 48 to the tip of the tip portion 49.
- the resin 55 is injected from the injection groove 51 between the needle tube 3 and the insertion hole 50 in a state where the proximal end portion 3 b of the needle tube 3 is inserted into the holding hole 53 of the connection portion 52. . Thereby, a part of the fixing portion 47 is formed, and the needle tube 3 can be firmly fixed to the syringe 42.
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- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
Description
(1)薬剤が充填され、かつ生体に穿刺可能な針先を有する針管を固定するための固定部が接続される接続部を有するシリンジを成形する工程。
(2)針管の針先と反対側の基端部をシリンジの接続部に設けた保持孔に挿入する工程。
(3)シリンジと実質的に同一の材料から樹脂で固定部の少なくとも一部を成形することで、針管を固定部に固定する工程。
なお、説明は以下の順序で行う。
1.第1の実施の形態例
1-1.針付きシリンジの構成例
1-2.針付きシリンジの組み立て
2.第2の実施の形態例
3.第3の実施の形態例
1-1.針付きシリンジの構成例
まず、図1~図7を参照して本発明の第1の実施の形態例(以下、「本例」という。)にかかる針付きシリンジについて説明する。
図1は本例の針付きシリンジを示す斜視図、図2は本例の針付きシリンジの要部を示す斜視図である。図3は本例の針付きシリンジにかかる外筒を示す断面図である。図4は、外筒に針管を装着した状態を示す断面図、図5は、外筒に樹脂を注入した状態を示す断面図である。
まず、針管3について説明する。
針管3は、ISOの医療用針管の基準(ISO9626:1991/Amd.1:2001(E))で10~33ゲージのサイズ(外径:φ3.5~0.2mm)のものを使用し、好ましくは16~33ゲージ(外径:φ1.7~0.2mm)のものを使用する。図4Aに示すように、この針管3の軸方向の一端には、針先3aを鋭角にするための刃面が形成されている。そして、針管3の軸方向の一側の針先3aが生体に穿刺される。
次に、シリンジ2について説明する。
図3に示すように、シリンジ2は、薬剤が充填される本体6と、この本体6に連続する固定部7を備えている。そして、本体6と固定部7との間には、接続部12が設けられている。本体6は、略円筒形に形成されており、この本体6の軸方向の一側に固定部7が連続して形成され、軸方向の他端が開口している。また、プレフィルドシリンジの場合は、この本体6の筒孔6aに薬剤が充填され、本体6の軸方向の他側から押し子のガスケットが打栓される。
次に、図6及び図7を参照してキャップ4について説明する。
図6は、針付きシリンジ1にキャップ4を取り付けた状態を示す斜視図、図6は図7に示す針付きシリンジ1とキャップ4を示す断面図である。
次に、上述したような構成を有する針付きシリンジ1の組み立て方法について図3~図5を参照して説明する。
次に、図8及び図9を参照して本発明の針付きシリンジの第2の実施の形態例について説明する。
図8及び図9は、第2の実施の形態にかかる針付きシリンジの要部を示す斜視図である。
次に、図10及び図11を参照して本発明の針付きシリンジの第3の実施の形態例について説明する。
図10及び図11は、第3の実施の形態にかかる針付きシリンジの要部を示す説明図である。
Claims (6)
- 生体に穿刺可能な針先を有する針管と、
薬剤が充填される本体と、前記本体に連続して形成され、かつ前記針管の前記針先を突出させた状態で前記針管を固定する固定部と、前記固定部と前記本体が接続する接続部と、を有するシリンジと、を備え、
前記シリンジの前記接続部には、前記針管における前記針先と反対側の基端部を保持する保持孔が設けられており、
前記針管の前記基端部を前記保持孔に挿入した後に、前記シリンジと実質的に同一の材料からなる樹脂で前記固定部の少なくとも一部を形成することで、前記針管が前記固定部に固定される
針付きシリンジ。 - 前記シリンジの前記固定部には、前記保持孔と連続し、かつ前記針管が挿入される挿入穴と、前記挿入穴と前記針管との間に前記樹脂を注入するための注入部が設けられている
請求項1に記載の針付きシリンジ。 - 前記保持孔は、前記本体から前記固定部に向かうにつれて、その径が大きくなるようにテーパー状に開口している
請求項1に記載の針付きシリンジ。 - 前記挿入穴は、前記固定部における前記針管の針先が突出する先端部から前記本体に向かうにつれてその径が小さくなるテーパー状に形成されている
請求項2に記載の針付きシリンジ。 - 薬剤が充填され、かつ生体に穿刺可能な針先を有する針管を固定するための固定部が接続される接続部を有するシリンジを成形する工程と、
前記針管の前記針先と反対側の基端部を前記シリンジの前記接続部に設けた保持孔に挿入する工程と、
前記シリンジと実質的に同一の材料から樹脂で前記固定部の少なくとも一部を成形することで、前記針管を前記固定部に固定する工程と、
を含む針付きシリンジの製造方法。 - 前記シリンジを成形する工程において、前記保持孔と連続し、かつ前記針管が挿入される挿入穴と、前記樹脂を注入するための注入部と、を有する前記固定部を予め前記シリンジと一体に成形し、
前記針管を前記固定部に固定する工程において、前記注入部から前記挿入穴と前記針管との間に前記樹脂を注入することで前記固定部の一部を成形する
請求項5に記載の針付きシリンジの製造方法。
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CN2011800654753A CN103313745A (zh) | 2011-01-19 | 2011-11-25 | 带针注射器及带针注射器的制造方法 |
US13/980,863 US20130296801A1 (en) | 2011-01-19 | 2011-11-25 | Syringe provided with needle, and method for producing syringe provided with needle |
JP2012553569A JPWO2012098767A1 (ja) | 2011-01-19 | 2011-11-25 | 針付きシリンジ及び針付きシリンジの製造方法 |
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Cited By (4)
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CN105188814A (zh) * | 2013-03-07 | 2015-12-23 | 泰尔茂株式会社 | 带针外筒的制造方法及带针外筒 |
KR101700723B1 (ko) * | 2015-12-28 | 2017-02-13 | 주식회사 유성메디컬 | 멀티니들 조립체의 멀티니들과 로드 간의 조립구조 |
JP2019088873A (ja) * | 2013-11-03 | 2019-06-13 | テルモ株式会社 | シリンジ用外筒、プレフィルドシリンジおよびそれを用いた医療用液体投与具 |
JP2020525192A (ja) * | 2017-06-27 | 2020-08-27 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | ペンニードルマルチキャリア注入システム |
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CN104548279A (zh) * | 2015-01-12 | 2015-04-29 | 江苏磐宇科技有限公司 | 可换针自毁式注射器的生产方法 |
CN109803714B (zh) * | 2016-10-17 | 2021-07-09 | 医疗部件有限公司 | 针套管-导管粘接方法和装置 |
WO2022204851A1 (zh) * | 2021-03-29 | 2022-10-06 | 上海金塔医用器材有限公司 | 防针刺注射器 |
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CN103313745A (zh) | 2013-09-18 |
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