WO2013038887A1 - 液体注入器具 - Google Patents

液体注入器具 Download PDF

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Publication number
WO2013038887A1
WO2013038887A1 PCT/JP2012/071314 JP2012071314W WO2013038887A1 WO 2013038887 A1 WO2013038887 A1 WO 2013038887A1 JP 2012071314 W JP2012071314 W JP 2012071314W WO 2013038887 A1 WO2013038887 A1 WO 2013038887A1
Authority
WO
WIPO (PCT)
Prior art keywords
inner plug
injection device
liquid
protector
liquid injection
Prior art date
Application number
PCT/JP2012/071314
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
信之介 大津
小川　淳一
立川　浩一
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 WO2013038887A1 publication Critical patent/WO2013038887A1/ja

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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
    • 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
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the 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
    • 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
    • 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
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle
    • 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
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves

Definitions

  • the present invention relates to a liquid injection device.
  • a liquid injection device that can be applied to a prefilled syringe that contains a chemical solution or the like in advance is known (for example, see Patent Document 1).
  • the liquid injection device described in Patent Document 1 includes an outer cylinder having a liquid storage space therein, a liquid introduction section that is formed to protrude from the distal end portion of the outer cylinder, and that has a channel that communicates with the liquid storage space inside.
  • An inner plug that is installed on the outer periphery of the liquid introduction part and opens and closes the flow path, a hub as an operation member that operates the inner plug by rotating around the axis of the liquid introduction part, and a needle tube supported by the hub Have.
  • the inner plug can be rotated between a first position where the flow path is closed and a second position where the flow path is open. Further, in this liquid injection device, a protector that covers the needle tip of the needle tube in an unused state is attached to the hub.
  • the operation of the liquid injection device having such a configuration is performed as follows (1) to (3).
  • the operator operating the liquid injection device does not know the operation (2), for example, the operation (1) is performed, and then the operation (3) is performed. Because it is not, the operation cannot be performed. In this case, the operator may misunderstand that the liquid injection device is out of order.
  • An object of the present invention is to provide a liquid injection device capable of reliably completing preparations for injecting a liquid such as a chemical solution by a simple operation.
  • an outer cylinder having a liquid storage space inside; A liquid introduction part that protrudes from the distal end of the outer cylinder and has a flow path that communicates with the liquid storage space; The liquid introduction part is disposed so as to be displaceable, has a liquid introduction path that communicates with the flow path and can open the flow path, and the flow path and the liquid introduction path are blocked.
  • An inner plug that is displaced to a position of 1 and a second position at which the flow path and the liquid introduction path communicate with each other;
  • a needle hub attached to the inner plug;
  • a needle tube that is supported by the tip of the needle hub and communicates with the flow path via the liquid guiding path when the inner plug is in the second position;
  • a tubular protector body that covers the needle tube, a mounting portion that is provided on the proximal end side of the protector body and is fixed to the inner plug, and connects the protector body and the mounting portion, and the connection is released by breaking.
  • a breaker portion, and the mounting portion includes a protector fixed to the inner plug,
  • the inner plug is displaced from the first position to the second position in accordance with the detachment operation of the protector that breaks the breakage part and separates the protector body from the mounting part to expose the needle tube.
  • Liquid injection device characterized by.
  • the inner plug is installed so as to be rotatable around a central axis of the outer cylinder,
  • the detachment operation is preferably performed by rotating the protector together with the inner plug.
  • the inner plug includes a cylindrical inner plug body, a ring-shaped outer ring concentrically disposed outside the inner plug body, Having a connecting portion for connecting the stopper body and the outer ring; It is preferable that the mounting portion is fixed to the outer ring.
  • the mounting portion has a flange whose outer diameter is expanded on the outer peripheral portion of the base end,
  • the outer ring has a plurality of claw portions projecting inward at a tip of an inner peripheral portion thereof, It is preferable that the mounting portion is fixed to the outer ring by engaging the flange and the claw portion.
  • the breaking portion is broken by rotating the protector body and the mounting portion in opposite directions around the axis of the outer cylinder. .
  • the breaking force for breaking the breaking portion is set to be larger than the displacement force for displacing the inner plug.
  • the needle hub has a flange on the base end side outer peripheral portion, The flange of the needle hub is preferably sandwiched between the mounting portion and the inner plug to prevent the needle hub from being detached from the inner plug.
  • the liquid injection device of the present invention it is preferable that the liquid injection device is a prefilled syringe.
  • the detachment operation for detaching the protector and the switching operation for switching the flow path of the liquid introduction section from the closed state to the open state can be easily performed collectively by one operation on the protector.
  • the protector is detached by this operation, and preparation for injecting a liquid such as a chemical solution is reliably completed.
  • the protector since the protector is configured to be broken at the broken portion, it can be reliably determined whether or not the liquid injection device has been opened.
  • FIG. 1 is a perspective view showing an unused state (initial state) of a liquid filling device (first embodiment) of the present invention applied to a prefilled syringe.
  • FIG. 2 is an exploded perspective view of the liquid injection device shown in FIG. 3 is a cross-sectional view taken along line AA in FIG. 4 is a cross-sectional view taken along line BB in FIG.
  • FIG. 5 is a cross-sectional view taken along the line CC in FIG.
  • FIG. 6 is a longitudinal cross-sectional view during the operation of the liquid injection device (first embodiment) of the present invention.
  • FIG. 7 is a sectional view taken along line DD in FIG. FIG.
  • FIG. 8 is a perspective view showing a state where the protector is detached in the liquid injection device (first embodiment) of the present invention.
  • 9 is a cross-sectional view taken along line EE in FIG.
  • FIG. 10 is a cross-sectional view showing a second embodiment of the liquid injection device of the present invention.
  • FIG. 11 is a longitudinal sectional view showing a third embodiment of the liquid injection device of the present invention.
  • liquid injection device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
  • FIG. 1 is a perspective view showing the liquid injection device of the present invention (first embodiment) applied to a prefilled syringe, and showing its unused state (initial state).
  • FIG. 2 is an exploded perspective view of the liquid injection device shown in FIG. 3 is a cross-sectional view taken along line AA in FIG. 1
  • FIG. 4 is a cross-sectional view taken along line BB in FIG. 1
  • FIG. 5 is a cross-sectional view taken along line CC in FIG.
  • FIG. 7 is a longitudinal sectional view during operation of the liquid injection device of the present invention (first embodiment)
  • FIG. 7 is a cross-sectional view along the line DD in FIG. 6
  • FIG. 8 is the liquid injection device of the present invention (first embodiment).
  • FIG. 9 is a sectional view taken along line EE in FIG.
  • the lower side in FIGS. 1 to 6, 8 and 9 is referred to as “base end”, and the upper side is referred to as “tip”.
  • the liquid injection device 1 shown in each figure is a prefilled syringe filled with a liquid Q in advance, and includes a liquid injection device main body 2, an inner plug 7 installed at the tip of the liquid injection device main body 2, and an inner plug 7. And a protector (cap) 9 that covers the injection needle 10.
  • a protector (cap) 9 that covers the injection needle 10.
  • the liquid injection device main body 2 includes an outer cylinder (syringe outer cylinder) 3, a liquid guiding part 4 formed to project from the tip of the outer cylinder 3, and a gasket (not shown) that can slide in a liquid-tight manner within the outer cylinder 3. And a plunger 29 that is connected to the gasket and moves the gasket within the outer cylinder 3.
  • the outer cylinder 3 is composed of a bottomed cylindrical member having a bottom 31, and a liquid storage space 33 is formed in a portion surrounded by the gasket.
  • the liquid Q is stored in the liquid storage space 33.
  • the liquid Q to be stored include protein medical products such as antibodies, peptide medical products such as hormones, nucleic acid medical products, cell medicines, blood products, vaccines for preventing various infectious diseases, anticancer agents, anesthesia Drugs, medical narcotics, antibiotics, steroids, proteolytic enzyme inhibitors, sugar injections such as heparin and glucose, electrolyte correction injections such as sodium chloride and potassium lactate, vitamins, fat emulsions, contrast agents, Examples include stimulants.
  • the outer cylinder 3 is preferably substantially transparent in order to ensure internal visibility. Thereby, the liquid Q can be confirmed.
  • a plate-like flange 32 is provided on the outer periphery of the base end of the outer cylinder 3.
  • a liquid introduction part 4 having a diameter smaller than that of the outer cylinder 3 and projecting toward the tip is integrally formed.
  • the liquid introduction part 4 has a cylindrical shape, and a flow path 41 communicating with the liquid storage space 33 is formed therein.
  • the front end of the flow path 41 (the end opposite to the liquid storage space 33) forms a pair of side holes 42 that open to the outer peripheral portion (side surface) 44 of the liquid introduction portion 4.
  • These side holes 42 are provided on the substantially opposite side with respect to the central axis O of the liquid guiding part 4, that is, around the central axis O of the liquid guiding part 4 at intervals of 180 °.
  • a ring-shaped recess 43 along the circumferential direction is formed in the outer peripheral portion 44 of the liquid introducing portion 4, that is, in a portion closer to the tip than the side hole 42 of the liquid introducing portion 4.
  • the inner plug 7 can be engaged with the recess 43. This reliably prevents the inner plug 7 from being detached from the liquid introduction part 4. Further, as will be described later, the inner plug 7 can be rotated around the central axis O of the liquid introduction section 4 and the rotation is smoothly performed.
  • the inner plug 7 includes a cylindrical inner plug body 71 and a ring-shaped outer ring concentrically disposed outside the inner plug body 71. 72, and a connecting portion 73 that connects the inner plug main body 71 and the outer ring 72.
  • the inner peripheral portion 711 of the inner plug main body 71 is formed with an engaging portion 74 protruding in a ring shape along the circumferential direction.
  • the engaging portion 74 can engage with the concave portion 43 of the liquid guiding portion 4.
  • the other detailed configuration of the inner plug 7 will be described later.
  • the outer tube 3, the plunger 29, liquid guiding section 4, as each of the constituent material of the protector 9 is not particularly limited, for example, cyclic polyolefin (e.g., ethylene and tetracyclo [4.4.0.1 2.5 .1 7.10 ] -3-dodecene copolymer, etc.), polyvinyl chloride, polyethylene, polypropylene, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, acrylonitrile-butadiene-styrene copolymer, Examples thereof include various resins such as polyesters such as polyethylene terephthalate, butadiene-styrene copolymers, polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), polyethersulfone, and polysulfone.
  • cyclic polyolefin e.g., ethylene and tetracyclo [4.4.0.1 2.5 .1 7.10 ] -3-dode
  • cyclic polyolefins for example, ethylene and tetracyclo [4.4.0.1 2.5 5.1 7.10 ] -3-dodecene copolymer, etc.
  • polypropylene for example, polypropylene, poly- Resins such as (4-methylpentene-1), polyethersulfone and polysulfone are preferred.
  • the constituent material of the inner plug 7 is not particularly limited.
  • resins such as HDPE (high density polyethylene) and LDPE (low density polyethylene), natural rubber, butyl rubber, isoprene rubber, butadiene rubber
  • various rubber materials such as styrene-butadiene rubber and silicone rubber, various thermoplastic elastomers such as polyurethane, polyester, polyamide, olefin, and styrene, or elastic materials such as a mixture thereof may be used.
  • the inner plug 7 may be integrally molded so that only the portion in contact with the liquid Q is made of an elastic material and the other portion is made of resin.
  • An injection needle 10 is attached to the outer peripheral portion 712 of the inner stopper main body 71 of the inner stopper 7.
  • the injection needle 10 has a hub (needle hub) 11 and a needle tube 12 supported and fixed to the tip of the hub 11.
  • the hub 11 is composed of a cylindrical member, and the inner plug 7 is inserted into the proximal end portion of the lumen portion 111 thereof. As a result, the hub 11 is attached to the inner plug body 71 of the inner plug 7. At this time, the liquid tightness is maintained between the inner peripheral portion 112 of the hub 11 and the outer peripheral portion 712 of the inner plug main body 71.
  • a flange 113 composed of a plate-shaped, that is, a diameter-enlarged portion whose outer diameter is enlarged is provided on the outer peripheral portion of the base end of the hub 11. The flange 113 is in contact with the connecting portion 73 of the inner plug 7.
  • the constituent material of the hub 11 is not particularly limited.
  • the same constituent material as that of the outer cylinder 3 can be used.
  • a hollow needle tube 12 is inserted into the distal end portion of the lumen 111 of the hub 11.
  • the needle tube 12 is fixed in a liquid-tight manner to the hub 11 by, for example, a method using adhesion (adhesion with an adhesive or a solvent).
  • the needle tube 12 thus fixed communicates with the lumen 111 of the hub 11 at its lumen.
  • a sharp needle tip 122 is formed at the tip of the needle tube 12. Thereby, the target site can be punctured and the liquid Q can be injected in that state.
  • the shape of the needle tip 122 is not particularly limited, and preferably has a shape having a blade surface inclined at a predetermined angle with respect to the axis of the needle tube 12, as shown in FIG.
  • the needle tube 12 is made of, for example, a metal material such as stainless steel, aluminum, an aluminum alloy, titanium, or a titanium alloy.
  • the inner plug 7 includes the inner plug main body 71, the outer ring 72, and the connecting portion 73.
  • the inner plug 7 is installed so as to be rotatable (displaceable) around the central axis O (of the outer cylinder 3) with respect to the liquid introduction part 4 (see FIGS. 3 and 6).
  • a liquid introduction path 75 is formed in the cylindrical inner plug main body 71.
  • the liquid guide path 75 is centered on the wall portion (tube wall) of the inner plug main body 71, that is, a lateral hole 751 that is a through hole formed through the inner peripheral portion 711 to the outer peripheral portion 712 and the outer peripheral portion 712.
  • the vertical groove 752 is formed along the direction of the axis O. The longitudinal end of the vertical groove 752 opens to the horizontal hole 751, communicates with the horizontal hole 751, and the distal end opens to the distal end surface 713 of the inner plug main body 71.
  • the inner plug 7 is rotated with respect to the liquid introduction part 4 to take two positions, that is, a first position (see FIG. 3) and a second position (see FIGS. 6 and 9). obtain.
  • each side hole 42 of the flow channel 41 of the liquid introduction part 4 is sealed by the inner peripheral part 711 of the inner plug main body 71.
  • the liquid injection device 1 is in a blocked state in which the liquid introduction path 75 of the inner plug 7 and the flow path 41 of the liquid introduction section 4 are blocked.
  • the inner plug 7 When the inner plug 7 is rotated counterclockwise around the central axis O from the shut-off state shown in FIG. 3, the inner plug 7 is located at the second position. As shown in FIG. 6 (also in FIG. 9), at the second position, the lateral hole 751 of the liquid introduction path 75 faces one side hole 42 of the two side holes 42 of the flow path 41. Thereby, the liquid injection device 1 is in a communication state in which the liquid introduction path 75 of the inner plug 7 and the flow path 41 of the liquid introduction section 4 communicate with each other and the flow path 41 is opened. In the second position, the needle tube 12 of the injection needle 10 communicates with the flow path 41 via the liquid introduction path 75.
  • the liquid injection device 1 of the outer cylinder 3 communicates from the liquid storage space 33 to the needle tube 12.
  • the liquid Q in the liquid storage space 33 flows into the flow path 41 of the liquid guide section 4, the liquid guide path 75 of the inner plug 7, and the hub 11.
  • the needle tube 12 can be discharged through the cavity 111 in order.
  • the inner plug 7 rotates from the first position to the second position in conjunction with (in conjunction with) the detachment operation of the protector 9.
  • liquid tightness is maintained between the inner peripheral portion 112 of the hub 11 and the outer peripheral portion 712 of the inner plug main body 71.
  • the liquid tightness is also maintained between the inner peripheral part 711 of the inner plug main body 71 and the outer peripheral part 44 of the liquid guiding part 4.
  • the liquid Q is reliably prevented from leaking from each side hole 42 of the flow path 41 of the liquid introduction part 4, and In the second position, the liquid Q can surely flow down to the needle tube 12, and at that time, between the inner peripheral portion 711 of the inner plug main body 71 and the outer peripheral portion 44 of the liquid guide portion 4, Unintentional leakage between the inner peripheral portion 112 and the outer peripheral portion 712 of the inner plug main body 71 is prevented.
  • the liquid injection device 1 is configured such that the rotation range is regulated so that the inner plug 7 rotates between the first position and the second position.
  • the rotation restricting means 20 will be described.
  • the base end surface 731 of the connecting portion 73 of the inner plug 7 is formed with a protruding portion 76 that protrudes toward the central axis O side.
  • the projecting portion 76 has a mountain-like cross-sectional shape and has two inclined surfaces 761 and 762.
  • a stepped portion (stopper) 34 protruding in a plate shape is formed on the tip side portion of the bottom 31 of the outer cylinder 3.
  • the outer peripheral portion of the stepped portion 34 has a contact surface 341 that contacts the inclined surface 761 of the protrusion 76 when the inner plug 7 is in the first position, and a protrusion when the inner plug 7 is in the second position.
  • a contact surface 342 that contacts the inclined surface 762 of the portion 76 is provided.
  • the inner plug 7 When the inclined surface 761 of the projecting portion 76 and the contact surface 341 of the stepped portion 34 come into contact with each other, the inner plug 7 is reliably restricted from rotating clockwise from the first position in FIG. . Thereby, the interruption
  • the inner plug 7 is temporarily fixed with the inclined surface 762 of the projecting portion 76 abutting against the projection 343 formed to project from the stepped portion 34. As a result, the inner plug 7 is restricted from rotating unintentionally counterclockwise in FIG. 7 from the first position.
  • the protrusion 343 is formed with a slope 345 inclined in the same direction as the slope 762 at a portion where the slope 762 of the protrusion 76 contacts. Thereby, when the inner plug 7 rotates counterclockwise in FIG. 7 from the first position, the protrusion 76 can easily get over the protrusion 343.
  • the protrusion 344 is formed with a slope 346 that is inclined in the same direction as the slope 762 at a portion opposite to the portion where the slope 761 of the protrusion 76 contacts.
  • the rotation restricting means 20 is constituted by the protruding portion 76 of the inner plug 7 and the stepped portion 34 of the outer cylinder 3.
  • a protector 9 is attached to the inner plug 7.
  • the injection needle 10 hub 11
  • the protector 9 can cover the distal end side of the outer cylinder 3, that is, at least the needle tube 12 of the injection needle 10. Further, the above-described inner plug 7 is in the first position in the mounted state.
  • the liquid injection device 1 can also remove the protector 9 by applying a rotational force to the protector 9 in the mounted state, that is, remove it.
  • a rotational force to the protector 9 in the mounted state, that is, remove it.
  • the needle tube 12 of the injection needle 10 is exposed, and the target site can be punctured with the needle tip 122.
  • the protector 9 in the attached state is detached, the inner plug 7 is rotated to the second position along with (in conjunction with) the removal operation.
  • the protector 9 is provided between the protector body 91, the mounting portion 92 provided on the base end side of the protector body 91, and the protector body 91 and the mounting portion 92. And a broken portion 93.
  • the protector body 91 has a tubular shape with a closed end 911 and is a portion that can cover the needle tube 12 of the injection needle 10.
  • Two ring-shaped protrusions 94 are formed on the inner periphery of the base end of the protector main body 91 so as to protrude along the circumferential direction. These protrusions 94 are arranged apart from each other in the direction of the central axis O. Each protrusion 94 is in contact with the outer peripheral portion 114 of the hub 11 of the injection needle 10 in the mounted state. Thereby, the protector main body 91 is supported by the hub 11, and thus the protector main body 91 can be prevented from falling.
  • Each protrusion 94 also has a function of keeping the sterility of the needle tube 12, that is, blocking bacteria so that no bacteria enter between the needle tube 12 and the protector 9.
  • the mounting portion 92 is a portion that has a ring shape as a whole and is fixed to the inner peripheral portion 721 of the outer ring 72 of the inner plug 7.
  • a flange 95 composed of a diameter-enlarged portion having an enlarged outer diameter is provided on the outer peripheral portion of the base end of the mounting portion 92.
  • a plurality of (four in this embodiment) claw portions protrusions in this embodiment protrude toward the central axis O side at the tip of the inner peripheral portion 721 of the outer ring 72 of the inner plug 7.
  • Part 77 is formed. These claw portions 77 are arranged at equiangular intervals around the central axis O.
  • the flange 95 can be engaged with each claw portion 77 of the outer ring 72 of the inner plug 7, whereby the mounting portion 92 is fixed to the inner peripheral portion 721 of the outer ring 72 of the inner plug 7. That is, the state of being attached to the inner plug 7 is maintained.
  • a fixing method to the inner peripheral part 721 of the mounting part 92 not only the above-mentioned structure but adhesion
  • the outer ring 72 may be omitted from the inner plug 7 and the mounting portion 92 may be directly fixed to the connecting portion 73.
  • the flange 95 is formed with a plurality of (four in this embodiment) leg portions 96 projecting in the proximal direction.
  • the inner peripheral portion 721 of the outer ring 72 of the inner plug 7 is located at a position different from the claw portion 77, that is, at a base end side of the claw portion 77, on the central axis O side.
  • a plurality of projecting portions 78 are formed.
  • Each leg portion 96 of the mounting portion 92 is disposed on both sides of each projection 78 and can be engaged with the projection 78.
  • the rotational force is also transmitted to the inner plug 7 via the protrusion 78 that engages with the leg portion 96, and thus the inner plug 7 can rotate from the first position to the second position.
  • four through holes 79 are formed on both sides of the protrusion 78, and the leg portions 96 are inserted into the respective through holes 79 (see FIG. 4).
  • the rotational force applied to the protector 9 is also transmitted to the inner plug 7 through the inner peripheral portion (edge) of the through hole 79 that engages with the leg 96, and thus the inner plug 7 is in the first position. It is possible to reliably rotate from the position to the second position.
  • a recess 781 is formed in the center of one of the two protrusions 78.
  • the flange 95 of the protector 9 has A convex portion 99 is formed to protrude at a position different from the leg portion 96.
  • the convex portion 99 is inserted into the concave portion 781, whereby the protector 9 and the inner plug 7 are aligned.
  • the breaking portion 93 is a portion that connects the protector body 91 and the mounting portion 92 and releases the connection by breaking. As shown in FIGS. 3, 4, 6, and 9, the inner periphery of the protector body 91 and the inner periphery of the mounting part 92 are straddled in the vicinity of the boundary between the protector body 91 and the mounting part 92. A plurality of ribs 97 are formed in a protruding manner, and a slit 98 is formed along the circumferential direction from the outer peripheral side. Since the slit 98 is formed, a thin portion is formed in a part of each rib 97, and the thin portion becomes a fracture portion 93.
  • the protector body 91 is rotated counterclockwise around the central axis O with respect to the mounting portion 92 in a state where the inner plug 7 is in the second position. It is done by moving. Thereby, a shearing force acts on the fracture portion 93 and breaks when the fracture limit is exceeded.
  • the fracture surface 931 remains in the fractured portion 93 (see the cross-hatched portion in FIG. 9).
  • the breaking force for breaking the breaking portion 93 is set to be larger than the rotational force (displacement force) for rotating the inner plug 7. Due to the magnitude relation of the force, the inner plug 7 is attached to the breaker by breaking the breaker and separating the protector main body 91 from the mounting part 92 to expose the needle tube, that is, by the detaching operation to remove the protector 9. It can be displaced from the position 1 to the second position.
  • the method for setting the magnitude relationship of the force is not particularly limited, and examples thereof include a method for appropriately setting the depth of the slit 98 and a method for appropriately selecting the constituent material of the protector 9.
  • the protector main body 91 Even if the protector main body 91 once separated is attached so as to cover the needle tube 12 again, when the protector 9 is detached again, the protector main body 91 is not required to have a breaking force for breaking the breaking portion 93. The user can be made aware of the fact that it has been disconnected once. Further, when the breaking portion 93 is broken, a fracture surface 931 (the fracture surface 931 on the protector body 91 side is not shown) is formed on each of the protector body 91 side and the mounting portion 92 side, and the protector body 91 once separated. When the cover is mounted again so as to cover the needle tube 12, unless the fracture surfaces 931 on the protector main body 91 side and the mounting portion 92 side are aligned, the fracture surfaces 931 are shifted from each other.
  • the user can be made aware of the facts. Thus, it is possible to reliably determine whether the needle tube 12 has been exposed once, that is, whether the liquid injection device 1 has been opened.
  • the liquid injection device 1 is tamper-proof (once in use). The fact that you can confirm the fact later) is excellent.
  • the liquid injection device 1 is configured to prevent the hub 11 of the injection needle 10 from being detached from the inner plug 7 when the protector 9 is detached.
  • the separation preventing means 30 will be described.
  • the flange 95 can be engaged with each claw portion 77 of the outer ring 72 of the inner plug 7, and the separation from the inner plug 7 is prevented.
  • the distal end side of the flange 113 of the hub 11 of the injection needle 10 is engaged with the proximal end side of the mounting portion 92 from which the inner plug 7 is prevented from being detached (see FIGS. 3, 6, and 9). .
  • This reliably prevents the injection needle 10 from detaching from the inner plug 7, and thus the injection needle 10 is moved during the injection of the liquid Q with the liquid injection device 1, that is, during use of the liquid injection device. It can be surely prevented that it becomes detached and cannot be used.
  • the separation preventing means 30 is configured by the flange 95 of the mounting portion 92, each claw portion 77 of the inner plug 7, and the flange 113 of the hub 11.
  • FIG. 1 An unused liquid injection device 1 shown in FIG. 1 is prepared.
  • the inner plug 7 is located at the first position, whereby the flow path 41 of the liquid introduction unit 4 is closed, that is, the liquid introduction unit. In this state, the four flow paths 41 and the liquid introduction path 75 of the inner plug 7 are blocked.
  • the rotation restricting means 20 restricts the rotation of the inner plug 7 in the direction opposite to the direction toward the second position. Thereby, the interruption
  • the protector body 91 of the protector 9 is gripped with one hand, and the outer cylinder 3 is gripped with the other hand. Then, as it is, the protector body 91 is rotated in a predetermined direction around the central axis O, and the detachment operation of the protector body 91 is started. As described above, the rotational force (operating force) applied to the protector body 91 is transmitted to the mounting portion 92 and further to the inner plug 7 via the protrusion 78 that engages with the leg portion 96 of the mounting portion 92. Is done. Thus, the detachment operation of the protector main body 91 is performed by rotating the protector 9 together with the inner plug 7. In this operation, the injection needle 10 (hub 11) also rotates together with the protector 9 and the inner plug 7.
  • the protector 9 is rotated by a predetermined angle (90 ° in this embodiment)
  • the inner plug 7 is positioned at the second position as shown in FIG.
  • the flow path 41 of the liquid introduction part 4 is opened, that is, the communication state in which the flow path 41 of the liquid introduction part 4 communicates with the needle tube 12 of the injection needle 10 through the liquid introduction path 75 of the inner plug 7. It becomes.
  • the breaking force for breaking the breaking portion 93 is set to be larger than the rotational force for rotating the inner plug 7. Thereby, until the rotation to the 2nd position of the inner plug 7 is completed, it is prevented reliably that the fracture
  • the rotation restricting means 20 restricts the inner plug 7 from further rotating in the rotation direction from the second position. Thereby, the communication state in the liquid injection device 1 is reliably maintained.
  • the liquid injection device 1 a simple operation of rotating the protector 9 between the detaching operation for detaching the protector 9 and the switching operation for switching the flow path 41 of the liquid introduction part 4 from the closed state to the open state. (One action). Further, by this operation, the protector main body 91 is detached, and the needle tip 122 of the injection needle 10 is exposed, and as a result, the preparation for injecting the liquid Q is reliably completed. Therefore, it can be said that the liquid injection device 1 is excellent in operability.
  • the protector 9 protects the needle tip 122 of the needle tube 12 of the injection needle 10 and is not a rubber stopper. As a result, puncture resistance and coring that occur when the needle tip 122 punctures the rubber stopper can be prevented, and manufacture (assembly) of the liquid injection device 1 is facilitated. Further, when the needle tube 12 is 31G or thinner, trying to protect the needle tip 122 of the needle tube 12 with a rubber plug may cause the needle tube 12 to be bent or the needle tip 122 to be crushed when puncturing the rubber plug. There is a risk of malfunction. Such a problem can be prevented in the liquid injection device 1.
  • FIG. 10 is a cross-sectional view showing a second embodiment of the liquid injection device of the present invention.
  • This embodiment is the same as the first embodiment except that the configuration of the outer cylinder and the inner plug is different.
  • the inner plug 7 in the first position can be rotated in either the clockwise direction or the counterclockwise direction and displaced to the second position.
  • the outer peripheral portion of the step portion 34 of the bottom portion 31 of the outer cylinder 3 has the same configuration (shape) as the protrusion 343 in addition to the protrusion 343 that contacts the inclined surface 762 of the protrusion 76 when the inner plug 7 is in the first position.
  • the protrusion 343 ′ has a slope 345 ′ that contacts the slope 761.
  • the inner plug 7 is reliably restricted from rotating from the first position in the counterclockwise direction in FIG. 10 by the projection 343, and is rotated from the first position in the clockwise direction in FIG. 10 by the projection 343 ′. Movement is definitely regulated. Thereby, the interruption
  • the outer peripheral portion of the stepped portion 34 of the outer cylinder 3 has a central axis O in addition to the contact surface 342 that contacts the inclined surface 762 of the protruding portion 76 when the inner plug 7 is in the second position.
  • a contact surface 342 ′ arranged symmetrically with the contact surface 342 is provided.
  • a protrusion 344 ' having a slope 346' is formed on the outer periphery of the step portion 34 of the bottom 31 of the outer cylinder 3 in the same configuration (shape) as the protrusion 344.
  • the protrusion 344 ′ is disposed symmetrically with the protrusion 344 with the center axis O interposed therebetween.
  • the inner plug 7 is temporarily fixed with the inclined surface 762 of the protrusion 76 abutting against the protrusion 344 ′.
  • the involuntary rotation of the inner plug 7 from the second position in the clockwise direction in FIG. 10 is restricted.
  • FIG. 11 is a longitudinal sectional view showing a third embodiment of the liquid injection device of the present invention.
  • This embodiment is the same as the first embodiment except that the configurations of the protector and the inner plug are different.
  • the liquid injection device 1 shown in FIG. 11 is configured to prevent the protector 9 (the protector body 91) from rotating clockwise in FIG.
  • the protector main body 91 is formed with a protrusion 912 protruding at a part on the tip side of the outer peripheral portion of the fracture portion 93.
  • the protrusion 912 is arrange
  • the inner plug 7 has a protrusion 722 protruding from a part of the tip of the outer ring 72.
  • liquid injection device of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a liquid injection device is arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.
  • liquid injection device of the present invention may be a combination of any two or more configurations (features) of the above embodiments.
  • the protector is configured to be detached by a turning operation.
  • the protector is not limited thereto, and may be configured to be detached by a pulling operation, for example.
  • the inner plug is configured to move along the axial direction of the liquid guiding unit, thereby interlocking with the removing operation of the protector.
  • the flow path can be switched from the closed state to the open state.
  • the needle hub is configured to rotate during the protector detachment operation.
  • the present invention is not limited thereto, and the needle hub may be configured to be restricted during the protector detachment operation. Good.
  • the liquid injection device is formed so as to protrude from the distal end portion of the outer cylinder, and has a liquid introduction part having a flow path communicating with the liquid storage space therein, and is displaceable with respect to the liquid introduction part. And a first position where the flow path and the liquid guide path are blocked, and the flow path and the liquid guide path.
  • a middle plug that is displaced to a second position that communicates with the needle hub, a needle hub that is mounted on the middle plug, and a tip of the needle hub that is supported, and the inner plug is in the second position.
  • a needle tube that communicates with the flow path via the liquid introduction channel, a tubular protector body that covers the needle tube, a mounting portion that is provided on the proximal end side of the protector body and is fixed to the inner plug, The protector main body and the mounting portion are connected to each other, and a breakage portion for releasing the connection by breakage is provided.
  • a protector that is fixed, and the breaker is broken to separate the protector body from the mounting part, and the inner plug is moved from the first position along with the detachment operation of the protector to expose the needle tube. Displacement to the second position.
  • the detachment operation for detaching the protector and the switching operation for switching the flow path of the liquid introduction section from the closed state to the open state can be easily performed collectively by one operation on the protector.
  • the protector is detached by this operation, and preparation for injecting a liquid such as a chemical solution is reliably completed. Therefore, the liquid injection device of the present invention has industrial applicability.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
PCT/JP2012/071314 2011-09-14 2012-08-23 液体注入器具 WO2013038887A1 (ja)

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JP2011-200935 2011-09-14

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US10061899B2 (en) 2008-07-09 2018-08-28 Baxter International Inc. Home therapy machine
CN114929311A (zh) * 2020-03-24 2022-08-19 泰尔茂株式会社 注射器筒体用握把以及筒体组装体和注射器

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WO2015119284A1 (ja) * 2014-02-10 2015-08-13 三菱瓦斯化学株式会社 シリンジバレルの製造方法

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JP2001506508A (ja) * 1996-06-25 2001-05-22 ファルマ―コンサルト ゲゼルシャフト ミット ベシュレンクテル ハフツング オリジナル閉鎖機構を有する注射器ヘッド
JP2001070445A (ja) * 1999-08-31 2001-03-21 Kojiro Matsushita プレフィルドシリンジ
JP4598359B2 (ja) * 2000-07-17 2010-12-15 テルモ株式会社 液体注入器具
WO2009013844A1 (ja) * 2007-07-23 2009-01-29 Terumo Kabushiki Kaisha 薬液注入器具
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CN114929311A (zh) * 2020-03-24 2022-08-19 泰尔茂株式会社 注射器筒体用握把以及筒体组装体和注射器
CN114929311B (zh) * 2020-03-24 2023-07-28 泰尔茂株式会社 注射器筒体用握把以及筒体组装体和注射器

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