WO2013046857A1 - Ensemble élément de protection et seringue - Google Patents

Ensemble élément de protection et seringue Download PDF

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Publication number
WO2013046857A1
WO2013046857A1 PCT/JP2012/067588 JP2012067588W WO2013046857A1 WO 2013046857 A1 WO2013046857 A1 WO 2013046857A1 JP 2012067588 W JP2012067588 W JP 2012067588W WO 2013046857 A1 WO2013046857 A1 WO 2013046857A1
Authority
WO
WIPO (PCT)
Prior art keywords
protector
needle
outer cylinder
tip
needle body
Prior art date
Application number
PCT/JP2012/067588
Other languages
English (en)
Japanese (ja)
Inventor
小川　淳一
立川　浩一
陽一郎 岩瀬
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2013046857A1 publication Critical patent/WO2013046857A1/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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • 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
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3216—Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • 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
    • A61M5/50—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 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5013—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe
    • A61M5/502—Means for blocking the piston or the fluid passageway to prevent illegal refilling of a syringe for blocking the piston
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • 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
    • A61M5/46—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 having means for controlling depth of insertion

Definitions

  • the present invention relates to a protector and a syringe assembly.
  • an injection needle When performing blood collection or drug administration to a patient, an injection needle is attached to the tip of the syringe, and the injection needle is punctured into the patient's blood vessel.
  • an injection needle includes a needle tube having a sharp needle tip at the tip.
  • the plunger provided in the syringe When collecting blood from a patient, the plunger provided in the syringe is pulled to suck blood into the syringe. Moreover, when administering a chemical
  • the syringe that has finished blood collection and drug administration to the patient becomes unnecessary, it is provided for disposal together with the injection needle, but if it is discarded as it is, the discard operator mistakenly places a finger etc. at the needle tip of the needle tube.
  • the used syringe is equipped with a protector on the injection needle, and a measure is taken of discarding it while covering the needle tip with the protector (see, for example, Patent Document 1).
  • the protector of patent document 1 has an engagement piece which engages in the middle of the longitudinal direction of a needle tube in the state which covered the needle tip, and is comprised so that the state which covered the needle tip may be maintained by this.
  • An object of the present invention is to provide a protector and a syringe assembly that can reliably protect a needle body and can surely prevent erroneous insertion of a finger or the like by a needle tip of the needle body.
  • the needle body has a protruding portion protruding to 10 mm or less from the fixed portion toward the distal end side, The protector body is configured to cover the entire protrusion at the first position.
  • the protector body includes a top plate and a peripheral wall portion formed along an edge of the top plate along a circumferential direction thereof.
  • the protector according to (1) Projecting from the fixed portion toward the distal end, and disposed on the outer peripheral side of the needle body, abuts against the living body surface when puncturing the living body surface with the needle tip, at least 1
  • the protector according to (1) further including two contact portions.
  • the protector body biases the protector body in a direction in which the protector body rotates from the second position to the first position.
  • the protector as described in said (7).
  • an outer cylinder having a mouth part through which liquid can enter and exit at the tip part;
  • a puncture needle that has a sharp needle tip at the tip, has a long needle body, and is attached to the mouth;
  • a syringe assembly comprising: the protector according to (1) used for the puncture needle.
  • the puncture needle has a hub that supports the proximal end portion of the needle body,
  • the fixing portion is preferably attached to the hub.
  • the protector main body, the fixed portion, and the rotation support portion are integrally formed.
  • FIG. 1 is a partial longitudinal sectional view showing an embodiment of a syringe assembly including the protector of the present invention.
  • FIG. 2 is a perspective view showing the protector in FIG. 3 is a partial vertical cross-sectional side view showing an open / closed state of the protector shown in FIG.
  • FIG. 4 is a schematic diagram for explaining an example of a method of using the syringe assembly shown in FIG.
  • FIG. 1 is a partial longitudinal sectional view showing an embodiment of a syringe assembly including the protector of the present invention
  • FIG. 2 is a perspective view showing the protector in FIG. 1
  • FIG. 3 is an open / closed state of the protector shown in FIG.
  • FIG. 4 is a schematic diagram for explaining an example of a method for using the syringe assembly shown in FIG. 1.
  • the upper side in FIGS. 1 and 4 is referred to as the “base end”
  • the lower side is referred to as the “tip”
  • the lower side in FIGS. 2 and 3 is referred to as the “base end”
  • a syringe assembly 400 shown in FIG. 1 includes a syringe 1, an intradermal needle (puncture needle) 200 attached to the syringe 1, and a protector 9 attached to the intradermal needle 200.
  • a syringe assembly 400 shown in FIG. 1 includes a syringe 1, an intradermal needle (puncture needle) 200 attached to the syringe 1, and a protector 9 attached to the intradermal needle 200.
  • the configuration of each unit will be described.
  • the syringe 1 is a prefilled syringe in which a chemical solution 100 is stored in advance.
  • a syringe 1 includes an outer cylinder 2, a gasket 3 that can slide in the outer cylinder 2, a pusher 4 that operates to move the gasket 3, a guide portion 8, a detachment preventing means 5, and a state maintaining means. 6 and urging means 7 are provided.
  • a liquid chemical solution 100 is stored in advance in a space 14 surrounded by the outer cylinder 2 and the gasket 3, which is located on the tip side of the gasket 3.
  • the drug solution 100 is not particularly limited.
  • protein drugs such as antibodies, peptide drugs such as hormones, nucleic acid drugs, cell drugs, blood products, vaccines for preventing various infectious diseases, anticancer agents, anesthetics, and the like.
  • Narcotics antibiotics, steroids, protease inhibitors, heparin, glucose injections such as glucose, electrolyte correction injections such as sodium chloride and potassium lactate, vitamins, fat emulsions, contrast agents, etc. .
  • the outer cylinder 2 is composed of a bottomed cylindrical member. As shown in FIG. 1, the outer cylinder 2 includes a barrel portion 21 having a bottom portion 211, a plate-like flange 27 provided on the outer periphery of the proximal end of the barrel portion 21, and a central portion of the bottom portion 211. A diameter-reduced portion 22 having a diameter reduced with respect to 21 is formed, and these are integrally formed. The reduced diameter portion 22 forms a mouth portion through which liquid can enter and exit. The intradermal needle 200 is fitted and attached to the mouth portion (reduced diameter portion 22).
  • a film (not shown) is attached to the opening of the reduced diameter portion 22 before the intradermal needle (puncture needle) 200 is attached as a sealing member, or a cap (not shown) is attached.
  • the lumen of the reduced diameter portion 22 is hermetically sealed.
  • Examples of the constituent material of the outer cylinder 2 include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, Various resins such as polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, and polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12) can be mentioned. Resin such as polypropylene, cyclic polyolefin, polyester, and poly- (4-methylpentene-1) is preferable because it is easy to mold.
  • the outer cylinder 2 is preferably substantially transparent in order to ensure internal visibility.
  • a gasket 3 made of an elastic material is accommodated in the outer cylinder 2.
  • a plurality of ring-shaped protrusions are formed on the entire outer periphery of the gasket 3.
  • the constituent material of the gasket 3 is not particularly limited.
  • various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, polyamide,
  • elastic materials such as various thermoplastic elastomers such as olefins and styrenes, or mixtures thereof.
  • the pusher 4 is provided so as to be movable in the longitudinal direction of the outer cylinder 2 with respect to the outer cylinder 2. As shown in FIG. 1, the pusher 4 includes a gripping portion 41 that is gripped by the user and a pressing portion 42 that presses the gasket 3. In the following, for convenience of explanation, the state shown in FIG. 1 is also referred to as “unused state”.
  • the pressing portion 42 has a rod shape and is inserted into the outer cylinder 2 from the tip side.
  • the pressing portion 42 is connected to the bottom portion 412 of the grip portion 41 at the base end portion.
  • Such a pressing portion 42 is formed integrally with the grip portion 41.
  • the pressing part 42 is spaced apart from the gasket 3 in the longitudinal direction of the outer cylinder 2 when not in use. Therefore, when the pusher 4 is moved a predetermined distance from the unused state toward the distal end side with respect to the outer cylinder 2, the pressing portion 42 contacts the gasket 3. If it moves to, the press part 42 will press a gasket and the gasket 3 will move to the front end side of the outer cylinder 2.
  • FIG. thus, by setting it as the structure which the press part 42 spaced apart from the gasket 3 in the unused state, as mentioned later, the reliability and safety
  • the gripping portion 41 has a bottomed cylindrical shape having a bottom portion 412 and covers the entire area around the outer tube 2. By making the grip portion 41 in such a shape, the syringe 1 can be easily gripped, and the operability of the syringe 1 is improved.
  • the grip portion 41 is configured such that the reduced diameter portion 22 of the outer cylinder 2 protrudes from the opening 41a in an unused state. By allowing the reduced diameter portion 22 to protrude from the grip portion 41 in an unused state, the intradermal needle 200 can be easily attached to the reduced diameter portion 22.
  • the inner wall 411 of the gripper 41 is in contact with the outer peripheral surface of the flange 27 of the outer cylinder 2, and when the gripper 41 and the outer cylinder 2 move relative to each other in the longitudinal direction of the outer cylinder 2, the flange 27 And the inner wall 411 of the holding part 41 slide. Therefore, rattling with respect to the outer cylinder 2 can be suppressed at the proximal end portion of the grip portion 41, and the relative movement between the grip portion 41 and the outer tube 2 can be performed smoothly.
  • the gripping portion 41 has a configuration in which the outer cylinder 2 is prohibited from rotating in the circumferential direction. Thereby, the unintentional displacement of the outer cylinder 2 with respect to the holding part 41 can be suppressed, and the operability of the syringe 1 is improved.
  • the inner shape of the grip portion 41 is made into a substantially rounded rectangular shape (oval shape), and the shape of the flange 27 is made to correspond thereto, thereby preventing the rotation of the outer cylinder 2 in the grip portion 41.
  • the structure for preventing the rotation of the outer cylinder 2 is not limited to this. For example, a protrusion protruding from the inner wall 411 is formed, and the rotation of the outer cylinder 2 is performed by contacting the protrusion with the outer cylinder 2. It may be suppressed.
  • the gripping portion 41 is configured to suppress the rolling of the syringe 1 in the circumferential direction. Thereby, the safety
  • the outer shape of the gripping portion 41 is made into a substantially rounded rectangular shape (oval shape) that is substantially similar to its inner shape, and a part of the outer periphery is configured as a flat surface, thereby suppressing the rolling of the syringe 1. ing.
  • a structure which suppresses the rolling of the syringe 1 it is not limited to this, For example, it is good also as a structure which formed the permite
  • the grip portion 41 has a shape that can be easily gripped by the user, and thus the operability of the syringe 1 is also improved.
  • the total length of the grip portion 41 is not particularly limited as long as it can be gripped.
  • the grip portion 41 is configured so that the outer cylinder 2 located inside can be visually recognized. Thereby, since the state of the chemical
  • a configuration is not particularly limited, and examples thereof include a method of configuring the gripping portion 41 with a substantially transparent member.
  • a long window portion extending in the longitudinal direction of the grip portion 41 may be provided so that the inside can be visually recognized through this window portion.
  • the said window part may be comprised with the transparent member and may be comprised with the through-hole.
  • the constituent material of the pusher 4 is not particularly limited, and for example, the same material as the constituent material of the outer cylinder 2 can be used.
  • the guide unit 8 has a function of guiding relative movement between the outer cylinder 2 and the gripping part 41 (movement in the longitudinal direction of the outer cylinder 2).
  • the grip portion 41 can be smoothly moved with respect to the outer cylinder 2, so that the operability of the syringe 1 is improved.
  • the guide portion 8 is provided between the outer cylinder 2 and the grip portion 41. Further, the guide portion 8 is fixed to the outer cylinder 2 and is located on the distal end side of the trunk portion 21.
  • the guide portion 8 has an annular shape, and the outer cylinder 2 is inserted inside the guide portion 8.
  • the guide part 8 can be fixed to the outer cylinder 2 by press-fitting the outer cylinder 2 inside the guide part 8.
  • the guide part 8 may be fixed to the outer cylinder 2 with an adhesive or the like.
  • the guide portion 8 is in contact with the distal end portion of the inner wall 411 of the grip portion 41 when not in use, and the grip portion 41 and the outer cylinder 2 move relatively in the longitudinal direction of the outer tube 2.
  • the inner wall 411 and the outer peripheral surface of the guide portion 8 slide. Therefore, rattling with respect to the outer cylinder 2 is suppressed at the distal end portion of the grip part 41, and the relative movement between the grip part 41 and the outer cylinder 2 can be performed smoothly.
  • the “rattle” includes a displacement other than the movement of the gripper 41 and the outer tube 2 in the longitudinal direction of the outer tube 2, that is, a direction orthogonal to the longitudinal direction of the outer tube 2 and this direction. The displacement in the direction.
  • rattling of the distal end portion of the gripping portion 41 is suppressed by the guide portion 8, so that the distal end portion of the gripping portion 41 moves forward in the movement direction, that is, the outer cylinder of the gripping portion 41. 2 can be moved more smoothly to the tip side. Therefore, the operability of the syringe 1 is improved.
  • the guide portion 8 suppresses rattling of the distal end portion of the gripping portion 41 and the flange 27 suppresses rattling of the proximal end portion of the gripping portion 41, that is, the gripping portion. Since the rattling of both end portions of 41 is suppressed, the relative movement between the grip portion 41 and the outer cylinder 2 can be performed more smoothly.
  • the constituent material of the guide portion 8 is not particularly limited, and for example, the same material as that of the outer cylinder 2 can be used.
  • the shape of the guide portion 8 is not limited to an annular shape as in the present embodiment as long as the function can be exhibited.
  • the structure in which the some guide part 8 is provided mutually spaced apart along the circumferential direction of the outer cylinder 2 may be sufficient.
  • the guide portion 8 may be formed integrally with the outer cylinder 2.
  • the guide portion 8 is fixed to the outer cylinder 2 and is slidable with respect to the inner wall 411 of the grip portion 41, but on the contrary, the guide portion 8 is attached to the grip portion 41. It may be fixed and slidable with respect to the outer wall of the outer cylinder 2. In this case, the guide portion 8 may be formed integrally with the grip portion 41.
  • the detachment prevention means 5 has a function of preventing the outer cylinder 2 from detaching from the grip portion 41.
  • the detachment preventing means 5 is constituted by a protrusion 51 provided on the grip portion 41.
  • the protrusion 51 is provided closer to the opening 41 a than the flange 27 of the inner wall 411 of the grip portion 41.
  • the outer cylinder 2 can no longer move toward the opening 41 a, thereby preventing the outer cylinder 2 from being detached from the grip portion 41.
  • the shape of the protrusion 51 is not particularly limited as long as the above function can be exhibited.
  • the protrusion 51 has a ring shape provided over the entire circumferential direction of the inner wall 411.
  • it can also be set as the structure by which the some protrusion 51 was provided mutually spaced along the circumferential direction of the inner wall 411.
  • FIG. Note that the protrusion 51 may be formed integrally with the grip portion 41 or may be formed as a separate body and fixed to the grip portion 41 using an adhesive or the like.
  • the state maintaining means 6 has a function of maintaining the state in which the grip portion 41 has moved to the tip side with respect to the outer cylinder 2 as compared with the unused state. Specifically, after the gripping part 41 moves to the distal end side with respect to the outer cylinder 2 by a predetermined distance or more, the gripping part 41 has a function of restricting the movement of the gripping part 41 to the proximal side with respect to the outer cylinder 2.
  • the state maintaining means 6 includes a protrusion 61 provided on the grip portion 41.
  • the protrusion 61 is provided on the base end side with respect to a portion in contact with the flange 27 of the inner wall 411 in an unused state. Then, after the flange 27 gets over the projection 61 by the gripping portion 41 moving to the distal end side with respect to the outer cylinder 2, the flange 27 abuts on the projection 61, so that the gripping portion 41 is fixed to the outer cylinder 2. Movement to the end side is restricted.
  • the lower surface (first surface) 611 that contacts when the grip portion 41 moves toward the distal end side with respect to the outer cylinder 2 is inclined with respect to the longitudinal direction of the outer cylinder 2, and the grip portion 41 is outside.
  • An upper surface (second surface) 612 that comes into contact with the tube 2 when moving toward the proximal end is orthogonal to the longitudinal direction of the outer tube 2. Therefore, when the grip portion 41 moves toward the distal end side with respect to the outer cylinder 2, the flange 27 can easily get over the protrusion 61, but on the contrary, the grip portion 41 moves toward the proximal end side with respect to the outer cylinder 2. When moving, the flange 27 cannot get over the protrusion 61.
  • the urging means 7 has a function of urging the outer cylinder 2 toward the distal end side with respect to the grip portion 41.
  • the pressing portion 4 and the gasket 3 are separated from each other in an unused state, but the urging means 7 maintains the state in which the pressing portion 4 and the gasket 3 are separated from each other. It also has a function.
  • the biasing means 7 includes a spring member 71. Thereby, the structure of the biasing means 7 becomes simple.
  • the spring member 71 is provided inside the grip portion 41 and between the bottom portion 412 of the grip portion 41 and the flange 27 of the outer cylinder 2.
  • the spring member 71 biases the outer cylinder 2 toward the distal end side with respect to the grip portion 41, and maintains a state in which the flange 27 is in contact with the protrusion 51 (this state is referred to as an “unused state”).
  • the outer tube 2 moves to the distal end side or the proximal end side with respect to the gripping portion 41 by its own weight, etc.
  • the unintentional relative movement of 2 can be prevented. Therefore, the operability and safety of the syringe 1 are improved.
  • the spring member 71 may be in a natural state in an unused state or may be in a contracted state (excluding a fully contracted state), but is preferably in a contracted state. As a result, the flange 27 comes into pressure contact with the protrusion 51, and the state where the pressing portion 42 and the gasket 3 are separated can be more reliably maintained.
  • the intradermal needle 200 includes a long needle body 220 and a hub 210 that supports the proximal end portion of the needle body 220.
  • the needle body 220 is a needle tube having a sharp needle tip 230 at the tip, but may be a double-ended needle.
  • the outer diameter of the needle body 220 differs depending on the purpose, but for example, when used for intradermal injection as in this embodiment, it is preferably 22 G or less, more preferably 34 to 26 G.
  • the needle body 220 is made of, for example, a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy.
  • the hub 210 is fixed to the base end of the needle body 220 in a liquid-tight manner.
  • the fixing method is not particularly limited, and examples thereof include caulking, fusion (thermal fusion, high frequency fusion, ultrasonic fusion, etc.), and adhesion (adhesion with an adhesive or a solvent).
  • the hub 210 has a cylindrical shape and is fixed to the reduced diameter portion 22 of the outer cylinder 2 by, for example, fitting or other screwing, and the intradermal needle 200 is attached to the syringe 1 by this fixing.
  • the constituent material of the hub 210 is not particularly limited, and for example, the same material as the constituent material of the outer cylinder 2 can be used.
  • the protector 9 includes a protector body 10, a fixing part 11, a rotation support part 12, a first contact part 13 a, and a second contact part 13 b.
  • the fixing part 11 is fitted to and mounted on the hub 210 of the intradermal needle 200 and is fixed to the intradermal needle 200.
  • the fixed portion 11 includes a circular top plate 111 and a peripheral wall portion 112 formed on the edge of the top plate 111 along the circumferential direction thereof.
  • a through hole 113 that penetrates in the thickness direction is formed at the center of the top plate 111.
  • the through-hole 113 allows the needle body 220 to be inserted in a state where the fixing portion 11 is attached to the hub 210 of the intradermal needle 200 (hereinafter, this state is referred to as “protector attached state”) (FIGS. 3 and 3). 4).
  • the needle body 220 has a protruding portion 240 that protrudes from the distal end surface of the first contact portion 13a on the top plate 111 toward the distal end side.
  • Protruding length L 1 of the projecting portion 240 is a 10mm or less, preferably 0.5 ⁇ 2 mm.
  • a stepped portion 115 having an outer diameter gradually decreased is formed in a portion on the surface 111a side of the top plate 111.
  • the protector body 10 can be fitted to the stepped portion 115.
  • the back surface (base end surface) 111b of the top plate 111 is in contact with the distal end surface of the hub 210 of the intradermal needle 200 when the protector is attached.
  • the projection length L 1 is reliably restricted constant.
  • the peripheral wall 112 is formed in a cylindrical shape on the back surface 111b side of the top plate 111.
  • a tapered portion 114 whose inner diameter gradually increases in the proximal direction is formed on the inner peripheral portion of the proximal end of the peripheral wall portion 112.
  • the tapered portion 114 can be fitted to the outer peripheral portion of the hub 210 of the intradermal needle 200 having the same taper angle as the tapered portion 114.
  • the protector main body 10 is rotatably supported with respect to such a fixing portion 11 via a rotation support portion 12. By this rotation, the protector body 10 can be opened and closed, that is, as shown in FIG. 3C, the first position closest to the fixed portion 11, and FIGS. ), The second position separated from the fixed portion 11 can be displaced.
  • a first abutting portion 13a and a second abutting portion 13b are formed on the surface 111a of the top plate 111 of the fixing portion 11 so as to protrude in the distal direction. .
  • the height of the first contact portion 13a is higher than the height of the second contact portion 13b.
  • the first contact portion 13 a has a ring shape in plan view, and is concentrically disposed on the outer peripheral side with respect to the needle body 220.
  • the second contact portion 13b has a ring shape in plan view, and is concentrically arranged so as to be separated from the outer peripheral side of the first contact portion 13a.
  • the first contact portion 13a and the second contact portion 13b as described above are used when the skin S is punctured with the needle body 220, respectively. It is the part that is addressed to (contacts) S. Thereby, the entire protrusion 240 can surely enter the skin S, and thus the puncture depth can be regulated to be constant.
  • the protector body 10 includes a circular top plate 101 and a peripheral wall portion 102 formed on the edge of the top plate 101 along the circumferential direction.
  • the protector body 10 has a flat outer shape (flat shape), and the height of the peripheral wall portion 102 is smaller than the height of the peripheral wall portion 112 of the fixed portion 11.
  • the protector body 10 has a shape which are suitable for covering the projecting length L 1 is relatively short needle body 220 as used for intradermal injection to be described later.
  • a finger-hanging portion 103 is formed on the outer peripheral portion of the peripheral wall portion 102 so as to protrude.
  • the protector body 10 can be rotated between the first position and the second position. Before and after puncturing the skin S with the needle body 220, the protector body 10 is set to the first position (reference) as shown in FIGS. 3 (c) and 4 (d). Further, when the skin S is punctured with the needle body 220, the protector body 10 is most separated from the second position, particularly from the fixing portion 11, as shown in FIGS. 3 (a) and 4 (a) to (c). Position (rotation limit).
  • the top plate 101 and the peripheral wall portion 102 of the protector body 10 and the top plate 111 of the fixing portion 11 can cover the entire protruding portion 240 of the needle body 220. Thereby, the protrusion part 240 before and after use can be reliably protected. Furthermore, in this 1st position, the top plate 101 and the surrounding wall part 102 of the protector main body 10, and the top plate 111 of the fixing
  • the needle body 220 can be used in a suitable state.
  • the distance L2 between the inner peripheral surface of the peripheral wall portion 102 of the protector body 10 and the outer peripheral surface of the needle body 220 at the first position is not particularly limited, but is preferably 5 to 10 mm, for example. More preferably, it is 5 to 8 mm.
  • the distance L 3 between the top plate 101 of the protector body 10 and the needle tip 230 of the needle body 220 at the first position is preferably 0.1 to 15 mm, for example, and preferably 1 to 7 mm. More preferred.
  • the entire protruding portion 240 of the needle body 220 is surrounded by the needle body 220 before and after the needle body 220 is used, so that the fingers 240 are prevented from touching the protruding portion 240. It is possible to surely prevent erroneous fingers such as fingers. In particular, after use, blood adheres to or remains on the surface of the needle body 220, and there is a risk of causing infection when a puncture occurs, but the protector 9 prevents the puncture, The syringe assembly 400 has high safety.
  • the protector body 10 has the peripheral wall portion 102 fitted to the step portion 115 of the top plate 111 at the first position. Thereby, it is possible to prevent the protector body 10 from unintentionally turning to the second position.
  • the protector body 10 when the skin S is punctured with the needle body 220, the protector body 10 can be set to a position farthest from the fixing portion 11, as shown in FIG. It is a position rotated about 180 degrees from. Thereby, when the skin S is punctured with the needle body 220, the protector body 10 can be prevented from interfering with the puncture.
  • Such a protector body 10 is rotatably supported by a rotation support portion 12.
  • the rotation support portion 12 includes a connecting portion 121 that connects the protector body 10 and the fixing portion 11, and an urging portion 122 that urges the protector body 10.
  • the connecting portion 121 has two thin portions 123 that are spaced apart from each other along the circumferential direction of the peripheral wall portion 112 of the fixed portion 11.
  • Each thin portion 123 is a portion that can be easily bent in conjunction with the rotation of the protector body 10 when the protector body 10 rotates. Thereby, the protector main body 10 is smoothly rotated.
  • the urging portion 122 is disposed between the two thin portions 123.
  • the urging portion 122 has a plate shape, one end thereof is supported by the peripheral wall portion 112 of the fixing portion 11, and the other end is supported by the top plate 101 of the protector body 10.
  • the urging portion 122 has a bent portion 124 bent in the middle in the longitudinal direction.
  • the bent portion 124 can be elastically deformed so that the bending angle changes according to the rotation angle while the protector body 10 is rotating.
  • the bent body 124 biases the protector body 10 in the rotating direction. A biasing force can be generated. Even if the operation force for performing the rotation operation is released by this urging force, the protector main body 10 can naturally rotate reliably to the first position.
  • the protector 9 is preferably formed by integrally forming a protector main body 10, a fixed portion 11, and a rotation support portion 12. Thereby, the protector main body 10, the fixing
  • thermoplastic resin As a constituent material of the protector 9, a thermoplastic resin can be used.
  • the thermoplastic resin include polyolefins such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, modified polyolefins, and polyamides (example: Nylon 6, nylon 46, nylon 66, nylon 610, nylon 612, nylon 11, nylon 12, nylon 6-12, nylon 6-66), thermoplastic polyimide, aromatic polyester and other liquid crystal polymers, polyphenylene oxide, polyphenylene sulfide, Polycarbonate, polymethyl methacrylate, polyether, polyether ether ketone, polyether imide, polyacetal, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester
  • thermoplastic elastomers such as polyamide-based, polybutadiene-based, trans-polyisoprene-based, fluororubber-based, chlorinated polyethylene, etc., or copolymers, blend
  • the usage method of the syringe assembly 400 shown below is a method of using the syringe 1 for "intradermal injection” which administers the chemical
  • the usage method of the syringe assembly 400 is this. It is not limited to.
  • the syringe assembly 400 is prepared.
  • the protector main body 10 if the protector main body 10 is in a closed state, the protector main body 10 is opened. Thereby, the protrusion part 240 of the needle body 220 is exposed. Further, in the closed state, as described above, the entire protruding portion 240 of the needle body 220 is surrounded by the protector body 10, and the protruding portion 240 is reliably protected. Thereby, the needle body 220 can be used in a suitable state.
  • the first contact portion 13 a of the fixing portion 11 of the protector 9 contacts the skin S in a direction substantially perpendicular to the skin S by gripping the grip portion 41. Until then, the needle body 220 is punctured into the skin S. At this time, since the protector body 10 is in the open state to the rotation limit, the protector body 10 is prevented from interfering with the puncture operation.
  • the way of gripping the grip portion 41 is not particularly limited, and for example, the grip portion 41 may be gripped or may be gripped.
  • the external force G1 in the contraction direction acts on the spring member 71 via the outer cylinder 2 due to the resistance generated by puncturing the needle body 220 into the skin.
  • the spring member 71 may not contract, its contracted length even if shrinkage (the difference in length after length before shrinkage and shrinkage) is shorter than the distance L 4 between the pressing portion 42 and the gasket 3 in the unused state. That is, just by puncturing the skin 220 with the needle body 220, the gasket 3 is not pressed by the pressing portion 42 and maintains the unused position. Thereby, it is possible to prevent the drug solution 100 from being ejected from the needle body 220 before the needle body 220 has completely pierced the skin S.
  • the hardness (elastic force) of the spring member 71 does not contract due to the external force G1, or even if it contracts, the distance L 4 between the pressing portion 42 and the gasket when the contraction length is unused. It is designed to be shorter. Thereby, the said effect is exhibited and the operativity and safety
  • the grasping portion 41 is pushed into the skin S side.
  • an external force G2 in the same direction as the external force G1 and greater than the external force G1 is applied to the outer cylinder 2, and the spring member 71 contracts and the gripping portion 41 moves toward the distal end side with respect to the outer cylinder 2.
  • the pressing portion 42 approaches the gasket 3, and the pressing portion 42 contacts the gasket 3. That is, when the external force G2 is applied, the separated state between the pressing portion 42 and the gasket 3 is released.
  • the periphery of the target portion of the skin S is pressed by the first contact portion 13a and the second contact portion 13b, and is slightly recessed.
  • the part of the skin S between the first contact part 13a and the second contact part 13b swells up in a mountain shape and is in contact with the tip surface of the first contact part 13a. Becomes perpendicular to the axis of the needle body 220 and becomes flat, and the needle tip 230 is punctured sufficiently and reliably into the skin S.
  • the flange 27 gets over the protrusion 61.
  • the flange 27 is pressed against the protrusion 61 by the biasing force of the spring member 71. Therefore, after it becomes a used state, the holding
  • the timing at which the flange 27 gets over the protrusion 61 may be before the gasket 3 has completely moved to the distal end side of the outer cylinder 2, but at almost the same time as the gasket 3 has completely moved to the distal end side.
  • the state maintaining means 6 is configured to maintain the positional relationship between the outer cylinder 2 and the grip portion 41 when the movement of the gasket 3 with respect to the outer cylinder 2 is completed. Thereby, it can be confirmed that the administration of the drug solution 100 is properly completed by the feeling and sound when the flange 27 gets over the protrusion 61. Therefore, it is possible to appropriately administer the medicinal solution 100, and it is prevented that the grasping portion 41 is pushed into the skin S side with an excessive force even though the administration is completed. Improve reliability and safety.
  • the gripper 41 is moved away from the skin S.
  • the outer cylinder 2 and the grip portion 41 may be inadvertently displaced. Therefore, the needle body 220 can be removed safely. Therefore, the operability and safety of the syringe 1 are improved.
  • the opened protector body 10 is rotated by, for example, a finger to be in a closed state.
  • the entire protruding portion 240 of the needle body 220 is surrounded by the protector main body 10, so that erroneous piercing by the protruding portion 240 can be reliably prevented.
  • the needle body 220 can be punctured into the skin S and the medicinal solution 100 can be administered only by grasping the grasping portion 41 and pressing it against the skin S side. That is, according to the syringe assembly 400, the administration of the drug solution 100 is completed in one step. Further, since the relative positional relationship between the grip portion 41 and the outer cylinder 2 can be maintained by the spring member 71, the needle body 220 can be safely punctured into the skin S and the like. Moreover, according to the syringe assembly 400, the chemical
  • the needle body 220 can be reliably protected by the protector 9 before and after puncturing, and erroneous piercing by the needle body 220 can also be reliably prevented. Therefore, the syringe assembly 400 is excellent in quality and safety.
  • the pressing part directly presses the gasket in the syringe.
  • an intermediate member may be interposed between the gasket and the pressing part.
  • a hard member for example, made of a resin material or the like
  • a gasket can be used. According to such a configuration, since the gasket moves when the pressing portion presses the hard intermediate member, excessive deformation of the gasket is suppressed as compared with the case where the gasket is directly pressed by the pressing portion. Can do.
  • the syringe demonstrated the structure which the pusher and the gasket spaced apart in the unused state in the said embodiment, it is not limited to this, For example, when a spring member does not shrink
  • an auxiliary tool that assists the attachment may be used.
  • the auxiliary device can store the intradermal needle, and is configured to prevent excessive force from being applied to the reduced diameter portion when the hub is connected to the reduced diameter portion in the stored state. It is a thing.
  • the outer cylinder moves to the proximal end side with respect to the grip portion, and the gasket may be pushed by the pressing portion, so that the reliability of the syringe is lowered.
  • the protector may be formed integrally with a hub that supports the needle body, that is, may have a function as a hub that supports the needle body.
  • the protector main body, the fixing portion, and the rotation support portion are integrally formed.
  • the protector main body, the fixing portion, and the rotation support portion are formed separately from each other. What connected the bodies may be used.
  • the protector rotates from the first position to the second position, and when the protector comes to the first position again, the protector maintains the state and prohibits the rotation to the second position. It may have.
  • the protector has two contact portions that contact the living body surface when the surface of the living body is punctured with the needle tip.
  • the present invention is not limited to this. There may be one, or three or more.
  • the protector of the present invention is a protector used for a puncture needle having a sharp needle tip at the tip and having a long needle body, and a fixed portion fixed to the needle body, and an outer shape Has a flat shape, and connects the protector body rotatable to the first position closest to the fixed part and the second position spaced apart from the fixed part, and connects the protector body and the fixed part.
  • a rotation support portion that rotatably supports the protector body, the needle body has a protruding portion that protrudes from the fixed portion toward the tip side to 10 mm or less, and the protector body is It is comprised so that the said protrusion part may be covered in the said 1st position.
  • the whole protrusion part of a needle body can be covered with the protector main body in a 1st position, Therefore
  • the needle body before and after use can be protected reliably.
  • the unintentional deformation of the needle body can be surely prevented, and thus the needle body can be used in a suitable state when the needle body is used.
  • the entire protruding portion of the needle body is covered before and after using the needle body, so that the fingertip of the needle body is prevented from touching the fingertip. Can be reliably prevented.
  • blood adheres and remains on the surface and inside of the needle body, and there is a risk of causing infection when a puncture occurs.
  • the puncture is prevented, the safety is high. .
  • the protector of the present invention has industrial applicability.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Selon l'invention, un élément de protection (9) est utilisé sur une aiguille intradermique (200) comportant un corps d'aiguille (220). Cet élément de protection (9) comprend une partie immobile (11) fixée au corps d'aiguille (220), un corps principal d'élément de protection (10) ayant un profil en forme d'éventail et apte à tourner entre une première position près de la partie immobile (11) et une seconde position éloignée de la partie fixe (11), et une partie de support de rotation (12) reliant le corps principal d'élément de protection (10) et la partie stationnaire (11) et supportant de manière rotative le corps principal d'élément de protection (10). Le corps principal d'élément de protection (10) peut recouvrir, à la première position, toute la partie saillante (240) faisant saillie de 10 mm ou moins à partir de la partie stationnaire (11) du corps d'aiguille (220) vers la pointe.
PCT/JP2012/067588 2011-09-26 2012-07-10 Ensemble élément de protection et seringue WO2013046857A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2011-209643 2011-09-26
JP2011209643 2011-09-26

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Publication Number Publication Date
WO2013046857A1 true WO2013046857A1 (fr) 2013-04-04

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520364A (ja) * 2013-04-24 2016-07-14 スター・シリンジ・リミテッド 注射器
WO2016158144A1 (fr) * 2015-03-27 2016-10-06 テルモ株式会社 Dispositif d'injection de médicament
CN107427646A (zh) * 2015-03-27 2017-12-01 泰尔茂株式会社 注射针组装体和药剂注射装置
WO2019147906A1 (fr) * 2018-01-26 2019-08-01 Becton, Dickinson And Company Seringue de rinçage à capuchon rabattable
US11890446B2 (en) 2020-04-17 2024-02-06 Becton, Dickinson And Company Cap for male and female threaded fittings
US11890445B2 (en) 2019-12-23 2024-02-06 Becton, Dickinson And Company Universal disinfection cap
US11969572B2 (en) 2020-04-17 2024-04-30 Becton, Dickinson And Company Disinfection cap
US11975168B2 (en) 2019-11-18 2024-05-07 Becton, Dickinson And Company Disinfectant cap

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Publication number Priority date Publication date Assignee Title
JPH06190039A (ja) * 1992-09-23 1994-07-12 Becton Dickinson & Co 皮下注射器のための保護キャップ
JP2006061739A (ja) * 2005-11-21 2006-03-09 Shiyoufuu:Kk 歯科用粘性材料充填シリンジ
JP2011045725A (ja) * 2004-01-07 2011-03-10 Smiths Medical Asd Inc 規格ゲージに固有の色で符号化した針保護装置およびその製造方法
JP2011115345A (ja) * 2009-12-02 2011-06-16 Terumo Corp プレフィルドシリンジ
JP2011212183A (ja) * 2010-03-31 2011-10-27 Terumo Corp プレフィルドシリンジ

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH06190039A (ja) * 1992-09-23 1994-07-12 Becton Dickinson & Co 皮下注射器のための保護キャップ
JP2011045725A (ja) * 2004-01-07 2011-03-10 Smiths Medical Asd Inc 規格ゲージに固有の色で符号化した針保護装置およびその製造方法
JP2006061739A (ja) * 2005-11-21 2006-03-09 Shiyoufuu:Kk 歯科用粘性材料充填シリンジ
JP2011115345A (ja) * 2009-12-02 2011-06-16 Terumo Corp プレフィルドシリンジ
JP2011212183A (ja) * 2010-03-31 2011-10-27 Terumo Corp プレフィルドシリンジ

Cited By (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016520364A (ja) * 2013-04-24 2016-07-14 スター・シリンジ・リミテッド 注射器
WO2016158144A1 (fr) * 2015-03-27 2016-10-06 テルモ株式会社 Dispositif d'injection de médicament
CN107427646A (zh) * 2015-03-27 2017-12-01 泰尔茂株式会社 注射针组装体和药剂注射装置
JPWO2016158144A1 (ja) * 2015-03-27 2018-01-18 テルモ株式会社 薬剤注射装置
US20180015231A1 (en) * 2015-03-27 2018-01-18 Terumo Kabushiki Kaisha Injection needle assembly, and drug injection device
JPWO2016158143A1 (ja) * 2015-03-27 2018-01-25 テルモ株式会社 注射針組立体および薬剤注射装置
EP3275490A4 (fr) * 2015-03-27 2018-12-19 Terumo Kabushiki Kaisha Ensemble aiguille d'injection et dispositif d'injection de médicament
JP2021511131A (ja) * 2018-01-26 2021-05-06 ベクトン・ディキンソン・アンド・カンパニーＢｅｃｔｏｎ， Ｄｉｃｋｉｎｓｏｎ Ａｎｄ Ｃｏｍｐａｎｙ フリップキャップ付きフラッシュシリンジ
WO2019147906A1 (fr) * 2018-01-26 2019-08-01 Becton, Dickinson And Company Seringue de rinçage à capuchon rabattable
US11083847B2 (en) 2018-01-26 2021-08-10 Becton, Dickinson And Company Flush syringe with flip cap
JP7254085B2 (ja) 2018-01-26 2023-04-07 ベクトン・ディキンソン・アンド・カンパニー フリップキャップ付きフラッシュシリンジ
US11944792B2 (en) 2018-01-26 2024-04-02 Becton, Dickinson And Company Flush syringe with flip cap
US11975168B2 (en) 2019-11-18 2024-05-07 Becton, Dickinson And Company Disinfectant cap
US11890445B2 (en) 2019-12-23 2024-02-06 Becton, Dickinson And Company Universal disinfection cap
US11890446B2 (en) 2020-04-17 2024-02-06 Becton, Dickinson And Company Cap for male and female threaded fittings
US11969572B2 (en) 2020-04-17 2024-04-30 Becton, Dickinson And Company Disinfection cap

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