WO2012098766A1 - 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
- WO2012098766A1 WO2012098766A1 PCT/JP2011/077219 JP2011077219W WO2012098766A1 WO 2012098766 A1 WO2012098766 A1 WO 2012098766A1 JP 2011077219 W JP2011077219 W JP 2011077219W WO 2012098766 A1 WO2012098766 A1 WO 2012098766A1
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- WIPO (PCT)
- Prior art keywords
- needle
- holding member
- syringe
- outer cylinder
- tube
- Prior art date
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Classifications
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- 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
- B29C45/14336—Coating a portion of the article, e.g. the edge of the article
- B29C45/14426—Coating the end of wire-like or rod-like or cable-like or blade-like or belt-like articles
-
- 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
- B29C45/14549—Coating rod-like, wire-like or belt-like articles
-
- 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
- A61M5/34—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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
-
- 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
- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
- B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
- B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
- B29C65/16—Laser beams
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/05—Particular design of joint configurations
- B29C66/302—Particular design of joint configurations the area to be joined comprising melt initiators
- B29C66/3022—Particular design of joint configurations the area to be joined comprising melt initiators said melt initiators being integral with at least one of the parts to be joined
- B29C66/30223—Particular design of joint configurations the area to be joined comprising melt initiators said melt initiators being integral with at least one of the parts to be joined said melt initiators being rib-like
-
- 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
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
- B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
- B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
- B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7544—Injection needles, syringes
Definitions
- the present invention relates to a syringe with a needle in which a syringe is formed on a needle tube by insert molding and a method for manufacturing 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.
- an object of the present invention is to provide a syringe with a needle that can integrally form a needle tube and a syringe by insert molding without using an adhesive, and can simplify the mold. It is providing the manufacturing method of a syringe with a needle.
- a syringe with a needle of the present invention is formed on the same axis as the needle tube integrally with the needle tube by insert molding, and a needle tube having a needle tip that can be punctured into a living body.
- a needle holding member that has a distal end and a proximal end and holds the needle tube in a state in which the needle tip of the needle tube protrudes from the distal end side. Further, the proximal end side of the needle holding member has one end portion fixed by welding, and the other end portion provided on the opposite side of the one end portion in the axial direction and provided with an opening, and filled with a medicine.
- An outer cylinder. The needle holding member and the outer cylinder are formed of substantially the same material.
- the method for producing a syringe with a needle of the present invention includes the following steps (1) to (3).
- the needle holding member and the outer cylinder are formed of substantially the same material.
- the mold for insert molding can be reduced by separately forming the outer cylinder filled with the medicine and the needle holding member for holding the needle tube.
- the mold can be simplified.
- the needle tube and the needle holding member are integrally formed by insert molding, the needle tube can be fixed without using an adhesive.
- the outer cylinder and the needle holding member are formed from the same material and bonded, good bonding between the outer cylinder and the needle holding member can be obtained.
- FIG. 4A and 4B show a manufacturing method of an embodiment of a syringe with a needle according to the present invention, FIG. 4A is a sectional view showing a needle tube, FIG. 4B is a sectional view showing a state in which the needle tube and a needle holding member are integrated, and FIG.
- 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 a needle of this example
- FIG. 4 is an explanatory diagram showing a method for manufacturing the syringe with a needle of this example.
- 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.5 and FIG.6) 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.
- the needle tip 3a on one side in the axial direction of the needle tube 3 protrudes from the distal end portion of a needle holding member 7 of the syringe 2 to be described later, and the other in the axial direction opposite to the needle tip 3a.
- the proximal end portion 3 b on the side protrudes from the proximal end portion of the needle holding member 7.
- the syringe 2 includes an outer cylinder 6 filled with a medicine and a needle holding member 7 that holds the needle tube 3.
- the outer cylinder 6 is formed in a substantially cylindrical shape, and the needle holding member 7 is fixed to one end 6 b that is one side in the axial direction of the outer cylinder 6, and the shaft of the one end 6 b.
- An opening is provided in the other end 6f which is the opposite side of the direction.
- the cylindrical hole 6a of the outer cylinder 6 is filled with a medicine, and a pusher gasket is plugged from the other side in the axial direction of the outer cylinder 6.
- a holding hole 6c is provided at one end 6b of the outer cylinder 6 in the axial direction.
- the holding hole 6c is opened in a tapered shape such that its diameter continuously increases in the direction from the other side in the axial direction of the outer cylinder 6 toward one side.
- the base end 3b which is the other end in the axial direction of the needle tube 3, is inserted into the holding hole 6c (see FIG. 4C). Then, by inserting the proximal end portion 3b of the needle tube 3 into the holding hole 6c, the tube hole 6a of the outer tube 6 and the needle tube 3 communicate with each other.
- the outer cylinder 6 and the needle holding member 7 are integrally joined by welding the needle holding member 7 to the end surface 6d opposite to the cylinder hole 6a side in the one end portion 6b.
- the end surface 6d is provided with a concave portion 6e that mates with a protrusion 8b of a needle holding member 7 to be described later.
- the recess 6e is recessed from the end surface 6d toward the other side in the axial direction.
- the shape of the outer cylinder 6 may be a hollow square column shape or a hexagonal column shape.
- Examples of the material of the outer cylinder 6 having the above-described configuration include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene.
- Examples thereof include various resins such as copolymers, 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 outer cylinder 6 is substantially transparent in order to ensure internal visibility.
- the drug filled in the cylindrical hole 6a of the outer cylinder 6 may be any drug that is normally used as an injection.
- protein drugs such as antibodies, peptide drugs such as hormones, nucleic acid drugs, cells Pharmaceuticals, blood products, vaccines to prevent various infectious diseases, anticancer agents, anesthetics, narcotics, antibiotics, steroids, proteolytic enzyme inhibitors, heparin, glucose injections such as glucose, sodium chloride and potassium lactate
- electrolyte correction injection solutions such as vitamins, fat emulsions, contrast agents, and stimulants.
- the needle holding member 7 is welded to one side of the outer cylinder 6 in the axial direction.
- Examples of the method for welding the needle holding member 7 and the outer cylinder 6 include ultrasonic welding and laser welding.
- the needle holding member 7 has a distal end and a proximal end, and is integrally formed coaxially with the needle tube 3 by insert molding in a state where the needle tip 3a of the needle tube 3 protrudes from the distal end side. . Then, the needle tube 3 is disposed at the axial center of the needle holding member 7 along the axial direction thereof.
- the needle holding member 7 has a connection portion 8 joined to one end of the outer cylinder 6 in the axial direction and a close contact portion 9 continuous from the connection portion 8.
- the connecting portion 8 is formed in a cross shape in a cross section in a direction orthogonal to the axial direction of the needle holding member 7.
- the diameter of the connecting portion 8 on the close contact portion 9 side is smaller than the outer diameter of the close contact portion 9. Therefore, the needle holding member 7 has a shape in which the connection portion between the connection portion 8 and the close contact portion 9 is constricted.
- connection part 8 is formed so that it may become thin as it leaves
- a protrusion 8b is formed on the contact surface 8a that contacts the end surface 6d of the outer cylinder 6 in the connecting portion 8.
- This protrusion 8 b is connected to a recess 6 e provided on the end surface 6 d of the outer cylinder 6.
- the protrusion 8b and the recessed part 6e can connect, and the needle holding member 7 and the outer cylinder 6 can be aligned.
- the protrusion 8b is melted by heat generated when the needle holding member 7 and the outer cylinder 6 are welded. Thereby, the joining property of the needle holding member 7 and the outer cylinder 6 can be enhanced.
- the outer cylinder 6 is provided with the recess 6e and the needle holding member 7 is provided with the protrusion 8b.
- the outer cylinder 6 is provided with a protrusion and the protrusion is connected to the needle holding member 7. May be provided. Furthermore, it is good also as a structure which provides an outer flange part in the axial direction other end side of the connection part 8 in the needle holding member 7, and provides a protrusion or a recessed part in this outer flange part.
- the shape of the connecting portion 8 may be a substantially cylindrical shape, a quadrangular prism shape, or a hexagonal prism shape.
- a close contact 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 needle holding member 7.
- the close contact portion 9 is formed in a substantially cylindrical shape.
- the needle tip 3a of the needle tube 3 projects from one side in the axial direction of the close contact portion 9.
- adherence part 9 is a shape corresponding to the shape of the cylinder hole 4a of the cap 4, it will be square pillar shape or hexagonal note shape There may be.
- the needle holding member 7 having the above-described configuration is made of substantially the same material as the outer cylinder 6. Therefore, when the needle holding member 7 and the outer cylinder 6 are welded, good bonding properties can be obtained, and the needle holding member 7 and the outer cylinder 6 can be firmly fixed. Moreover, since the welding surface of the outer cylinder 6 and the needle holding member 7 can be made inconspicuous, the appearance of the syringe 2 can be improved. Furthermore, by dividing the syringe 2 into the outer cylinder 6 and the needle holding member 7, it is possible to reduce the size of the insert molding die.
- FIG. 5 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 needle holding member 7 of the syringe 2. Then, as shown in FIG. 6, the needle tip 3 a side of the needle tube 3 and the needle holding member 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 contact portion 9 of the needle holding member 7. Therefore, when the cap 4 is attached to the syringe 2, the outer peripheral surface of the contact portion 9 in the needle holding member 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, which is the distal end side, from the contact portion 9 of the needle holding member 7 is sealed by the contact 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 contact portion 9 and the connection portion 8 in the needle holding member 7 by its elastic force. Thereby, the inner peripheral surface of the cap 4 and the constricted portion of the needle holding member 7 are engaged, and the cap 4 can be prevented from being detached from the syringe 2 at the time of conveyance.
- the needle holding member 7 is formed on the needle tube 3 shown in FIG. 4A. Specifically, resin is poured into a mold provided with a needle tube, and insert molding is performed. As a result, as shown in FIG. 4B, the needle holding member 7 is formed around the needle tube 3, and the needle tube 3 is held by the needle holding member 7. At this time, the needle tip 3 a of the needle tube 3 protrudes from the distal end side of the needle holding member 7 which is one side of the contact portion 9 in the axial direction, and the proximal end portion 3 b of the needle tube 3 protrudes from the other axial side of the connection portion 8. To do.
- the outer cylinder 6 is molded separately from the needle tube 3 and the needle holding member 7 by a mold. Forming the outer cylinder 6 separately from the needle tube 3 eliminates the need to provide a portion for supporting the needle tube 3 in the core pin that forms the tube hole 6a when the outer cylinder 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. In addition, it is possible to reduce the size of the mold by molding the outer cylinder 6 and the needle holding member 7 separately.
- the contact surface 8 a of the needle holding member 7 and the end surface 6 d of the outer cylinder 6 are brought into contact, and the proximal end portion 3 b of the needle tube 3 held by the needle holding member 7 is brought into contact with the outer cylinder 6. Insert into the holding hole 6c.
- the holding hole 6c is formed in a taper shape, the proximal end portion 3b of the needle tube 3 can be easily inserted into the holding hole 6c, and the syringe 1 with a needle can be easily assembled.
- the contact surface 8 a of the needle holding member 7 and the end surface 6 d of the outer cylinder 6 are brought into contact with each other, the protrusion 8 b of the needle holding member 7 is inserted into the recess 6 e provided in the outer cylinder 6.
- the needle holding member 7 and the outer cylinder 6 can be aligned.
- the needle holding member 7 and the outer cylinder 6 can be aligned simply by inserting the proximal end portion 3b of the needle tube 3 into the holding hole 6c. The objective can be achieved.
- the contact surface of the outer cylinder 6 and the needle holding member 7 is welded, and the outer cylinder 6 and the needle holding member 7 are joined.
- the protrusion 8b provided on the needle holding member 7 is melted by the heat generated at the time of welding, and penetrates into the recess 6e or between the end surface 6d of the outer cylinder 6 and the contact surface 8a of the needle holding member 7.
- the outer cylinder 6 and the needle holding member 7 are formed of substantially the same material, good bondability can be obtained. Thereby, the needle holding member 7 and the outer cylinder 6 can be firmly fixed, and the assembly of the syringe 1 with a needle is completed.
- the needle holding member 7 and the needle tube 3 are integrally formed by insert molding, and the needle holding member 7 and the outer cylinder 6 that hold the needle tube 3 are fixed by welding. ing. Therefore, the needled syringe 1 can be assembled without using an adhesive. 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.
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Abstract
Description
(1)薬剤が充填される外筒を成形する工程。
(2)生体に穿刺可能な針先を有する針管を、針管を保持する針保持部材にインサート成形によって一体に形成する工程。
(3)針管と一体に形成された針保持部材を外筒に溶着によって固定する工程。
そして、針保持部材と外筒は、実質的に同一の材料によって形成される。
なお、説明は以下の順序で行う。
1.針付きシリンジの構成例
2.針付きシリンジの組み立て
まず、図1~図6を参照して本発明の実施の形態例(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、図4は本例の針付きシリンジの製造方法を示す説明図である。
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。
シリンジ2は、薬剤が充填される外筒6と、針管3を保持する針保持部材7を備えている。図3に示すように、外筒6は、略円筒形に形成されており、この外筒6の軸方向の一側である一端部6bに針保持部材7が固定され、一端部6bの軸方向の反対側である他端部6fに開口部が設けられている。また、プレフィルドシリンジの場合は、この外筒6の筒孔6aに薬剤が充填され、外筒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5及び図6を参照してキャップ4について説明する。
図5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5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4を参照して説明する。
Claims (5)
- 生体に穿刺可能な針先を有する針管と、
インサート成形によって前記針管と一体に前記針管の同軸上に形成されて、先端と基端を有し、先端側から前記針管の前記針先を突出させた状態で前記針管を保持する針保持部材と、
前記針保持部材の基端側が溶着によって固定される一端部と、前記一端部の軸方向の反対側に位置しており開口部が設けられた他端部と、を有し、かつ薬剤が充填される外筒と、を備え、
前記針保持部材と前記外筒は、実質的に同一の材料によって形成される
針付きシリンジ。 - 前記外筒の前記一端部には、前記針管における前記針先と反対側の基端部が挿入される保持孔が設けられている
請求項1に記載の針付きシリンジ。 - 前記保持孔は、前記外筒の前記他端部の側から前記一端部の側に向かう方向に、その径が連続的に大きくなるようにテーパー状に開口している
請求項2に記載の針付きシリンジ。 - 前記外筒の前記一端部における前記針保持部材が固定される端面には、突起又は凹部が形成されており、
前記針保持部材における前記外筒の前記一端部の端面と接触する接触面には、前記突起又は凹部と接続される凹部又は突起が設けられている
請求項1に記載の針付きシリンジ。 - 薬剤が充填される外筒を成形する工程と、
生体に穿刺可能な針先を有する針管を、前記針管を保持する針保持部材にインサート成形によって一体に形成する工程と、
前記針管と一体に形成された針保持部材を前記外筒に溶着によって固定する工程と、を含み
前記針保持部材と前記外筒は、実質的に同一の材料で形成される
針付きシリンジの製造方法。
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US13/980,693 US20130296800A1 (en) | 2011-01-19 | 2011-11-25 | Syringe provided with needle, and method for producing syringe provided with needle |
CN2011800654768A CN103328025A (zh) | 2011-01-19 | 2011-11-25 | 带针注射器及带针注射器的制造方法 |
JP2012553568A JPWO2012098766A1 (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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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 |
JPWO2016002389A1 (ja) * | 2014-07-02 | 2017-04-27 | テルモ株式会社 | 安全針アセンブリ |
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WO2015064299A1 (ja) * | 2013-11-03 | 2015-05-07 | テルモ株式会社 | 針付きシリンジ、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 |
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 |
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JPH0747124A (ja) * | 1993-08-04 | 1995-02-21 | Hisao Kataoka | 注射器 |
JP2004154210A (ja) * | 2002-11-05 | 2004-06-03 | Enomoto Co Ltd | 医療用具及び動物治療用具並びにその製造方法 |
JP2007503866A (ja) * | 2003-08-28 | 2007-03-01 | ベクトン・ディキンソン・アンド・カンパニー | 皮内注射装置 |
JP2007130052A (ja) * | 2005-11-08 | 2007-05-31 | Nipro Corp | 医療用注射針 |
-
2011
- 2011-11-25 JP JP2012553568A patent/JPWO2012098766A1/ja active Pending
- 2011-11-25 US US13/980,693 patent/US20130296800A1/en not_active Abandoned
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- 2011-11-25 WO PCT/JP2011/077219 patent/WO2012098766A1/ja active Application Filing
Patent Citations (4)
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JPH0747124A (ja) * | 1993-08-04 | 1995-02-21 | Hisao Kataoka | 注射器 |
JP2004154210A (ja) * | 2002-11-05 | 2004-06-03 | Enomoto Co Ltd | 医療用具及び動物治療用具並びにその製造方法 |
JP2007503866A (ja) * | 2003-08-28 | 2007-03-01 | ベクトン・ディキンソン・アンド・カンパニー | 皮内注射装置 |
JP2007130052A (ja) * | 2005-11-08 | 2007-05-31 | Nipro Corp | 医療用注射針 |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
JPWO2016002389A1 (ja) * | 2014-07-02 | 2017-04-27 | テルモ株式会社 | 安全針アセンブリ |
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