WO2024172557A1 - Automated medication injection device - Google Patents

Automated medication injection device Download PDF

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Publication number
WO2024172557A1
WO2024172557A1 PCT/KR2024/095206 KR2024095206W WO2024172557A1 WO 2024172557 A1 WO2024172557 A1 WO 2024172557A1 KR 2024095206 W KR2024095206 W KR 2024095206W WO 2024172557 A1 WO2024172557 A1 WO 2024172557A1
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WO
WIPO (PCT)
Prior art keywords
locking
proximal end
injection device
trigger
flexible element
Prior art date
Application number
PCT/KR2024/095206
Other languages
French (fr)
Korean (ko)
Inventor
황인호
김성욱
김원표
Original Assignee
주식회사 비에스엘
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
Priority claimed from KR1020230020359A external-priority patent/KR102682089B1/en
Priority claimed from KR1020230044635A external-priority patent/KR102694749B1/en
Application filed by 주식회사 비에스엘 filed Critical 주식회사 비에스엘
Publication of WO2024172557A1 publication Critical patent/WO2024172557A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; 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

Definitions

  • the embodiment relates to an automatic drug injection device.
  • a pen needle-type auto injector has been developed and is widely used, which can be carried around and inserted into an appropriate injection location, automatically inserting the needle into the muscle and automatically injecting the injection liquid by a spring or other device.
  • Korean Patent No. 10-2059765 discloses a drug injection device having an automatic feedback mechanism.
  • a drug delivery device (1) comprises a plunger rod (11) arranged to be biased toward the proximal end (3a), a plunger (13), a first elastic member, i.e., an energy accumulation member (15), which may be, for example, a spring, arranged to bias the plunger rod (11) in the proximal direction, a second elastic member or energy accumulation member (9) arranged to bias the drug delivery member cover (7) in the proximal direction, a tubular rotor (17) arranged to receive the plunger rod (11) and the first energy accumulation member (15), a tubular extension member (5) axially and rotationally fixed to the housing (3), a tubular operating member (17) arranged to receive a portion of the rear end cap (7) and the plunger rod (11) and referred to as a tubular rotor (17) hereinafter, and arranged to receive the first energy accumulation member (15).
  • an energy accumulation member i.e., an energy accumulation member (15) which may be, for example, a spring, arranged to bias the plunge
  • the exemplified drug delivery device (1) further comprises a signal generating member (21) hereinafter exemplified as a U-shaped bracket, hereinafter referred to as a "U-bracket", and a rod (19).
  • the exemplified drug delivery device (1) further comprises a drug container holder (23) and a drug container (25) provided with a needle (25a).
  • the plunger (13) is arranged to travel within the drug container (25) by linear displacement of the plunger rod (11) to discharge the drug through the needle (25a).
  • the plunger rod (11), the tubular extension member (5), the tubular actuating member (17), the energy accumulating member (15) and the signal generating member (21) form an automatic feedback mechanism or simply a feedback mechanism for the drug delivery device (1).
  • the feedback mechanism is arranged to notify the user of the start of the discharge of the drug from the drug container (25).
  • the plunger rod Before use, the plunger rod is positioned axially fixed in the initial position.
  • the drug delivery device When the drug delivery device is actuated, i.e. the user initiates drug delivery, the plunger rod is released from the initial position and is pushed proximally by the energy accumulating member.
  • the plunger rod When the plunger rod is displaced by a distance corresponding to the distance required for initiation of drug release, the contact between the first section of the plunger rod and the signal generating member will cease.
  • the plunger rod and the signal generating member are designed such that the axial overlap of the first section and the signal generating member at the initial position of the plunger rod is equal to or substantially equal to said distance.
  • the first section only supports the signal generating member during the axial displacement of the plunger rod distance corresponding to the distance required for initiation of drug release.
  • the signal generating member will bend radially inwardly without being biased in its radial direction. Thereby, the signal generating member will separate from the tubular extension member. Therefore, the signal generating element that was biased distally by the first energy accumulating element is no longer retained by the tubular extension element and will therefore be thrown toward the distal inner surface of the tubular extension element. This results in an audible "click” sound and also a tactile sensation to the user.
  • the embodiment aims to provide an automatic drug injection device in which a locking member that prevents movement of an activating member to prevent exposure of an injection needle after use of the automatic drug injection device also serves as a trigger member of a plunger, thereby reducing the number of parts and simplifying the structure.
  • the embodiment comprises: a tubular housing forming an exterior; a drug container having a drug storage portion storing a drug and an injection needle capable of penetrating the skin to inject the drug stored in the drug storage portion, the drug container being fixed to the tubular housing; an activating member slidably installed along the tubular housing and having a receiving hole formed in a sliding direction; a first elastic member urging the activating member in a proximal direction; a plunger activated by movement of the activating member to urge the drug in the drug container; a trigger housing installed at a distal end of the tubular housing and having a catch protrusion formed along a circumferential direction on the distal end side; a plunger slidably installed within the tubular locking member and having a plunger rod and a plurality of trigger arms extending distally from the plunger rod and having locking projections formed to catch on the catch protrusions of the trigger member; a safety pin module formed inside the tubular housing and having a tubular body, a head portion
  • an automatic drug injection device wherein the flexible element is formed in a trigger housing, a distal end of the trigger housing is inserted into a safety pin module, and before the safety pin module is moved distally by an activating member, the flexible element is received within the safety pin module and is in an inactive state where it is not locked with a locking hole of an activating arm.
  • an automatic drug injection device wherein the flexible element is formed in a trigger housing, and a proximal end of the flexible element and a proximal end of the locking hole have an inclined shape such that the proximal end of the flexible element slides radially outward when the activating member moves in a distal direction.
  • an automatic drug injection device characterized in that a distance from a distal end of an activating arm to a proximal end of a head portion of a safety pin module is longer than a distance from a proximal end of a locking hole to a proximal end of a tubular body of the safety pin module.
  • an automatic drug injection device further comprising a locking member installed in a receiving hole of an activating member and fixed to a tubular housing after moving from a first position to a second position by movement of the activating member; wherein the flexible element is characterized in that a proximal end thereof spreads radially outward when the locking member moves from the first position to the second position.
  • an automatic drug injection device wherein the locking member and the tubular housing have locking elements, and when the locking member moves to the second position, the locking elements of the locking member and the tubular housing are engaged with each other.
  • an automatic drug injection device characterized in that the flexible element is formed in a tubular housing.
  • an automatic drug injection device further comprising a drug holder for fixing a drug container to a tubular housing; wherein the flexible element is formed on the drug holder.
  • an automatic drug injection device characterized in that the length of a locking hole formed in an activating member is greater than or equal to the sum of the length of the locking member and the distance the locking member moves from a first position to a second position.
  • an automatic drug injection device characterized in that it further includes a securing element for fixing the position of the locking element in the first position before the activating element activates the plunger.
  • an automatic drug injection device wherein the securing element is formed on a proximal end of a flexible element and a locking member, and is characterized by a concave portion in which the proximal end of the flexible element is secured.
  • an automatic drug injection device characterized in that the securing element is a projection or a recess formed on a locking member, and a recess formed on a housing and configured to receive the projection of the locking member or a projection received in the recess of the locking member.
  • the automatic drug injection device provided by the embodiment has the advantage of reducing the number of parts and simplifying the structure by having the locking member function as a trigger for locking and unlocking the plunger and the locking member for locking the activation member after drug injection is completed to prevent exposure of the injection needle.
  • Figure 1 is a drawing showing a drug injection device having an automatic feedback mechanism according to the prior art
  • Figure 2 is an exploded view showing an automatic drug injection device according to the first embodiment
  • Figure 3 is a cross-sectional view illustrating an automatic drug injection device according to the first embodiment
  • FIG. 4 is a perspective view showing a state in which a flexible element of a trigger housing provided in an automatic drug injection device according to the first embodiment is deactivated and activated;
  • Figure 5 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment before release;
  • FIG. 6 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment immediately after release;
  • FIG. 7 is a cross-sectional view showing the distal end of the trigger housing of the automatic drug injection device according to the first embodiment after it has been locked with the activating member.
  • Figure 8 is an exploded view showing an automatic drug injection device according to the second embodiment
  • Figure 9 is an exploded cross-sectional view showing an automatic drug injection device according to the second embodiment.
  • FIG. 10 is a cross-sectional perspective view showing a housing of an automatic drug injection device according to the second embodiment
  • FIG. 11 is a perspective view showing an activation member of an automatic drug injection device according to a second embodiment
  • FIG. 12 is a perspective view showing a locking member of an automatic drug injection device according to the second embodiment.
  • Fig. 13 is a cross-sectional view showing the initial state of an automatic drug injection device according to the second embodiment
  • Figure 14 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment at the start of trigger release.
  • Figure 15 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after the trigger is released.
  • Figure 16 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after drug injection is completed.
  • Figure 17 is a cross-sectional view showing the final locked state after the activation member of the automatic drug injection device according to the second embodiment returns to the initial position.
  • FIG. 18 is a cross-sectional view showing a locking member and a flexible element of an automatic drug injection device according to a third embodiment
  • Fig. 19 is a perspective view showing a drug holder of an automatic drug injection device according to the third embodiment.
  • FIG. 20 is a drawing showing a locking member fixing element of an automatic drug injection device according to the fourth embodiment.
  • FIG. 21 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fifth embodiment.
  • proximal end refers to that end of a drug delivery device from which drug release can be provided. Thus, it is that end of the drug delivery device that is tapered toward an injection or release site. This definition also extends to any internal or external component of the drug delivery device, i.e., the proximal end of any component is the end closest to the proximal end of the drug delivery device. The “distal end” is the end opposite the proximal end.
  • Proximal direction means the direction from the distal end to the proximal end along the central axis of the drug delivery device.
  • distal direction means the direction opposite to "proximal direction.”
  • FIG. 2 is an exploded view illustrating an automatic drug injection device according to the first embodiment
  • FIG. 3 is a cross-sectional view illustrating an automatic drug injection device according to the first embodiment.
  • An automatic drug injection device comprises a tubular housing (100) forming an outer appearance, an activating member (200) slidably installed in the axial direction on the proximal end side of the tubular housing (100), and a first elastic member (300) that presses the activating member (200) in the proximal direction.
  • the proximal end (210) of the activating member (200) is exposed outside the proximal end of the tubular housing (100) before drug injection.
  • a trigger housing (500) is installed at the distal end of the tubular housing (100).
  • a plunger (400) is slidably installed inside the trigger housing (500).
  • a second elastic member (600) is installed between the trigger housing (500) and the plunger (400), and the second elastic member (600) is installed in a compressed state so as to pressurize the plunger (400) in the proximal direction.
  • the plunger (400) is locked so that it does not move in the proximal direction even when pressure from the second elastic member (600) is applied until the activation member (200) slides distally to activate the automatic drug injection device.
  • the activation member (200) has a tubular proximal end (210) and a contact surface at the end of the proximal end (210) that comes into contact with the user's skin.
  • a hole is provided in the center of the contact surface, and when the activation member (200) is retracted, an injection needle (720) is exposed through the hole.
  • the activating member (200) further includes an activating arm (220) extending distally from the proximal end (210).
  • a locking hole (222; see FIG. 5) for final locking of the activating member (200) is formed in the activating arm (220).
  • the trigger module for locking and unlocking the plunger (400) is composed of a plunger (400), a trigger housing (500), and a second elastic member (600), and the trigger module operates only when the safety pin (830) of the safety pin module (800) is released.
  • the plunger (400) has a plunger rod (410) that slides into a drug container (710) to be described later and injects a drug solution, and a plurality of trigger arms (420) that extend in a distal direction from a distal end of the plunger rod (410).
  • the plurality of trigger arms (420) are formed at intervals from each other along the outer periphery of the distal end of the plunger rod (410), and a cavity is formed in the center of the trigger arms (420).
  • a safety pin (830) of a safety pin module (800) to be described later is inserted into the cavity.
  • An arrowhead-shaped locking protrusion (422) is formed at the distal end of the trigger arm (420).
  • the trigger housing (500) has a tubular body (510) as described above, and a ring-shaped catch (520) is formed along the inner surface of the body (510) at the distal end.
  • a safety pin module (800) is coupled to the distal end of the tubular housing (100).
  • the safety pin module (800) has a tubular body (810), a head portion (820) formed at the distal end of the tubular body (810), and a safety pin (830) protruding from the head portion (820) in a proximal direction and inserted into an inner cavity of the trigger arms (420).
  • the trigger housing (500) is fixed to the tubular housing (100), and the distal end of the trigger housing (500) is located within the safety pin module (800), i.e., within the tubular body (810).
  • the locking projection (422) of the trigger arm (420) is spread outward in the radial direction when the safety pin (830) is inserted, and is locked with the catch (520) of the trigger housing (500).
  • the locking of the trigger housing (500) and the trigger arm (420) is not released unless the safety pin (830) of the safety pin module (800) is removed from the cavity between the trigger arms (420).
  • the trigger arm (420) is elastically movable in the radial direction, and when the safety pin (830) is not inserted into the middle of the trigger arms (420), it is preferable that the protruding radius of the locking projection (422) is smaller than the inner diameter of the catch (520) of the trigger housing (500). Accordingly, when the safety pin (830) is removed, the trigger arm (420) moves to the original position, and the locking of the catch (520) and the locking projection (422) is easily released.
  • a drug container (700) having a drug storage section (710) for storing a drug and an injection needle (720) for injecting the drug stored in the tubular housing (100) is installed in the tubular housing (100).
  • the drug container (700) maintains a fixed position in the tubular housing (100) regardless of movement of the activating member (200) or the plunger (400).
  • the proximal end of the plunger (400) is assembled in a state of being inserted into the drug storage unit (710) to a predetermined depth, so that when the second elastic member (600) presses the plunger (400), the plunger (400) moves in the proximal direction within the drug storage unit (710), and the drug is injected into the user's body through the injection needle (720).
  • FIG. 4 is a perspective view showing a flexible element of a trigger housing of an automatic drug injection device according to the first embodiment in a deactivated and activated state.
  • the trigger housing (500) has a flexible element (530) that acts as a trigger for locking and unlocking the plunger (400) and also performs a final locking function to prevent movement of the activating member (200) to prevent exposure of the injection needle after use of the automatic drug injection device is finished.
  • the trigger housing (500) has a cylindrical body (510), and is formed by cutting the cylindrical body (510), and has a flexible element (530) whose proximal end is a free end, its distal end is a fixed end, and its proximal end is elastically movable in the radial direction. At this time, it is preferable that the flexible element (530) protrudes more radially outwardly toward the proximal end. When no external force is applied, it is preferable that the proximal end of the flexible element (530) protrudes more radially outwardly than the outer surface of the activating member (200; see FIG. 4).
  • FIG. 5 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment before release
  • FIG. 6 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment immediately after release.
  • the activation arm (220) pushes the head (810) of the safety pin module (800) distally, thereby releasing the safety pin (830) and operating the trigger module.
  • the safety pin (830) is removed, and the locking projection (422) of the trigger arm (420) moves radially inward, thereby easily releasing the locking with the engaging projection (520) of the trigger housing (500).
  • the flexible element (530) of the trigger housing (500) is accommodated in the tubular body (810) of the safety pin module (800) in an elastically compressed state, and then, when the activating arm (220) of the activating member (200) moves the safety pin module (800) distally, the flexible element (530) comes out of the tubular body (810).
  • the plunger (400) is pressurized in the base direction by the restoring force of the second elastic member (600) that was compressed, and accordingly, the plunger (400) moves in the base direction within the drug storage unit (710; see FIG. 3) and pressurizes the drug solution so that it is injected into the user's body through the injection needle.
  • the proximal end of the locking hole (222) formed in the activation arm (220) of the activation member (200) is located further distally than the proximal end of the flexible element (530).
  • the distance from the distal end of the activation arm (220) of the activation member (200) to the proximal end of the head portion (810) of the safety pin module (830) is longer than the distance from the proximal end of the locking hole (222) formed in the activation arm (220) to the proximal end of the tubular body (810) of the safety pin module (800). Therefore, before the activation member (200) removes the safety pin (830) of the safety pin module (800) from the trigger module, the locking hole (222) is covered by the tubular body (810), and locking with the flexible element (530) is not achieved.
  • the flexible element (530) of the trigger housing (500) is pulled out of the tubular body (810) and is capable of locking, but is not locked with the locking hole (222). That is, the trigger housing (500) is activated to enable locking, but is not in a locked state.
  • FIG. 7 is a cross-sectional view showing the distal end of the trigger housing of the automatic drug injection device according to the first embodiment after it is locked with the activating member.
  • the external force applied to the activation member (200) disappears, and the activation member (200) slides in the base direction again due to the restoring force of the first elastic member (300; see FIGS. 2 and 3).
  • the flexible element (530) that was activated is inserted into the locking hole (222), thereby locking.
  • the activation member (200) cannot move due to the locking of the flexible element (530) in the locking hole (222).
  • the activation member (200) is finally locked, and in the final locked state, the injection needle (720; see FIGS. 2 and 3) of the drug container (700; see FIGS. 2 and 3) in which the drug injection has been completed is no longer exposed.
  • the proximal end (530a) of the flexible element (530) and the proximal end (222a) of the locking hole (222) have an inclined shape so that the proximal end (530a) of the flexible element (530) slides radially outwardly when the activation member (200) moves in the distal direction.
  • FIG. 8 is an exploded view illustrating an automatic drug injection device according to a second embodiment
  • FIG. 9 is an exploded cross-sectional view illustrating an automatic drug injection device according to a second embodiment
  • FIG. 10 is a cross-sectional perspective view illustrating a housing of the automatic drug injection device according to the second embodiment
  • FIG. 11 is a perspective view illustrating an activating member of the automatic drug injection device according to the second embodiment
  • FIG. 12 is a perspective view illustrating a locking member of the automatic drug injection device according to the second embodiment.
  • An automatic drug injection device comprises a drug storage unit (710) that stores a drug in a tubular housing (100b) that forms an exterior, and a drug container having an injection needle (720) that can inject the drug stored in the drug storage unit (710) by penetrating the skin, and is fixed by a drug holder (730).
  • An activation member (200b) and a first elastic member that presses the activation member (200b) in a proximal direction are installed on the proximal side of the drug container in the tubular housing (100b), and a plunger (400) that pressurizes the drug and a trigger module (420, 500b, 700, 800) that deactivates the plunger (400) and then activates it by movement of the activation member (200) are installed on the distal side of the drug container.
  • the proximal end side of the tubular housing (100b) includes an activating member (200b) that is slidably installed in the axial direction, and a first elastic member (300) that presses the activating member (200b) in the distal direction.
  • the proximal end (210) of the activating member (200) is an open end, which is exposed outside the proximal end (110b) of the tubular housing (100b) before drug injection.
  • the distal end (120b) of the tubular housing (100b) is not open but is a closed end, which prevents a trigger module, which will be described later, from being separated from the tubular housing (100b) after the trigger is released.
  • the plunger (400) is installed in a locked manner within the trigger housing (500b), and when the trigger is released, the plunger (400) slides within the drug storage unit (710) and pressurizes the drug.
  • a second elastic member (600) is installed between the trigger housing (500b) and the plunger (400), and the second elastic member (600) is installed in a compressed state so as to pressurize the plunger (400) in the proximal direction.
  • the plunger (400) is locked so that it does not move in the proximal direction even when pressure from the second elastic member (600) is applied until the activation member (200b) slides distally to activate the automatic drug injection device.
  • a drug container (700) having a drug storage section (710) for storing a drug and an injection needle (720) for injecting the drug stored in the tubular housing (100b) is installed in the tubular housing (100b).
  • the drug container (700) is maintained in a fixed position in the tubular housing (100b) by the drug holder (700) regardless of movement of the activating member (200b) or the plunger (400).
  • the proximal end of the plunger (400) is assembled in a state of being inserted into the drug storage unit (710) to a predetermined depth, so that when the second elastic member (600) presses the plunger (400), the plunger (400) moves in the proximal direction within the drug storage unit (710), and the drug is injected into the user's body through the injection needle (720).
  • the activation member (200b) has a cap-shaped proximal end (210b) and a contact surface at the end of the proximal end (210b) that comes into contact with the user's skin.
  • a hole is provided in the center of the contact surface, and when the activation member (200b) is retracted, the injection needle (720) is exposed through the hole.
  • the activation member (200b) further includes an activation arm (220b) extending distally from the proximal end (210b).
  • a locking hole (222b) is formed in the activation arm (220b) to accommodate a locking member (900b) to be described later.
  • the trigger module for locking and unlocking the plunger (400) is composed of a trigger (420) of the plunger (400), a trigger housing (500b), a second elastic member (600), and a safety cap module (800), and the trigger module operates only when the safety pin (830) of the safety pin module (800) is released.
  • the plunger (400) has a plunger rod (410) that slides into a drug container (710) to be described later and injects a drug solution, and a plurality of trigger arms (420) that extend distally from a distal end of the plunger rod (410).
  • the plurality of trigger arms (420) are formed at intervals from each other along the outer periphery of the distal end of the plunger rod (410), and a cavity is formed in the center of the trigger arms (420).
  • a safety pin (830) of a safety pin module (800) to be described later is inserted into the cavity.
  • An arrowhead-shaped locking protrusion (422) is formed at the distal end of the trigger arm (420).
  • the trigger housing (500b) has a tubular body (510b), and a ring-shaped catch (520b) is formed along the inner surface of the body (510b) on the distal end side.
  • a safety pin module (800) is coupled to the distal end of the tubular housing (100).
  • the safety pin module (800) has a tubular body (810), a head portion (820) formed at the distal end of the tubular body (810), and a safety pin (830) protruding from the head portion (820) in a proximal direction and inserted into an inner cavity of the trigger arms (420).
  • the trigger housing (500b) is fixed to the tubular housing (100b), and the distal end of the trigger housing (500b) is located within the safety pin module (800), i.e., within the tubular body (810).
  • the locking projection (422) of the trigger arm (420) is spread outward in the radial direction when the safety pin (830) is inserted, and is locked with the engaging projection (520b) of the trigger housing (500b).
  • the locking of the trigger housing (500b) and the trigger arm (420) is not released unless the safety pin (830) of the safety pin module (800) is removed from the cavity between the trigger arms (420).
  • the trigger arm (420) is elastically movable in the radial direction, and when the safety pin (830) is not inserted into the middle of the trigger arms (420), it is preferable that the protruding radius of the locking projection (422) is smaller than the inner diameter of the engaging projection (520b) of the trigger housing (500b). Accordingly, when the safety pin (830) is removed, the trigger arm (420) moves to the original position, and the locking of the catch (520b) and the locking projection (422) is easily released.
  • the tubular housing (100b) is formed with a flexible element (130b) that is contracted by a locking member (900b) to be described later and then opens when the locking member (900b) moves to a second position to lock the activating member (200b).
  • a locking element is provided for fixing the position of the locking member (900b) when the locking member (900b) moves to the second position by the distal movement of the activating member (200b).
  • the locking element is a hole (910b) formed in the locking member (900b) and a locking projection (142b) formed in the tubular housing (100b) and inserted into the hole (910b).
  • the tubular housing (100b) may further include a stop projection (144b) in addition to the locking projection (142b), and the stop projection (144b) comes into contact with the distal end (920b) of the locking member (900b) to prevent the locking member (900b) from moving further in the distal direction.
  • the locking member (900b) is installed in the locking hole (222b) of the activating member (200b) as described above, and moves together with the activating member (200b) when the activating member (200b) slides distally, and moves from the first position to the second position.
  • the flexible element (130b) is contracted radially inwardly by the locking member (900b), and when the locking member (900b) moves to the second position, the proximal end thereof spreads radially outwardly.
  • the length of the locking hole (222b) formed in the activating member (200b) is greater than or equal to the sum of the length of the locking member (900b) and the distance that the locking member (900b) moves from the first position to the second position.
  • the locking member (900b) is fixed in the second position and does not move back to the first position, the proximal end of the flexible element (130b) continues to be spread out radially outward.
  • the activating member (200b) When the activating member (200b) is moved in the proximal direction by the restoring force of the first elastic member (300) and returns to the initial position, the proximal end of the flexible element (130b) is inserted into the locking hole (222b) of the activating member (200b), and even if a distal external force is applied to the activating member (200b) thereafter, the activating member (200b) is finally locked so as not to move due to the interference of the locking hole (222b) and the flexible element (130b). Therefore, the injection needle (720) is no longer exposed after the drug injection is completed.
  • Fig. 13 is a cross-sectional view showing the initial state of the automatic drug injection device according to the second embodiment
  • Fig. 14 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment at the start of trigger release.
  • the activating arm (220b) comes into contact with the head portion (810) of the safety pin module (830) and is pushed distally.
  • the locking member (900b) also begins to move distally together with the activating member (200b), and the proximal end of the flexible element (130b) of the housing (100b) also gradually comes out of the locking member (900b) and begins to spread outward in the radial direction.
  • the proximal end of the locking member (900b) maintains contact with the proximal end of the locking hole (222b) while moving from the first position to the second position.
  • Fig. 15 is a cross-sectional view showing the appearance of an automatic drug injection device according to the second embodiment after the trigger is released.
  • the safety pin (830) is released from the trigger arm (420) and the trigger module is activated.
  • the safety pin (830) is removed and the locking projection (422) of the trigger arm (420) moves radially inward, easily releasing the locking with the engaging projection (510b) of the trigger housing (500b).
  • the locking member (900b) accommodated in the locking hole (222b) of the activating member (200b) also reaches the second position, and the locking projection (142b) of the tubular housing (100b) and the locking hole (910b) of the locking member (900b) are locked with each other, and the position of the locking member (900b) is fixed at the second position.
  • the locking projection (142b) of the housing (100b) is locked into the locking hole (910b) of the locking member (900b), and the locking of the trigger arm (420) of the plunger (400) and the trigger housing (500b) is released.
  • the proximal end of the flexible element (130b) of the housing (100b) also completely escapes the locking member (900b) and spreads radially outward.
  • Figure 16 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after drug injection is completed.
  • the plunger (400) moves toward the base by the restoring force of the compressed second elastic member (600), and accordingly, the plunger (400) moves toward the base within the drug storage unit (710) and pressurizes the drug solution, which is injected into the user's body through the injection needle.
  • FIG. 17 is a cross-sectional view showing the final locked state after the activating member of the automatic drug injection device according to the second embodiment returns to the initial position.
  • the activation member (200b) moves toward the base by the restoring force of the first elastic member (300) and returns to the initial position, but the locking member (900b) installed in the locking hole (222b) is locked with the locking projection (142b) of the housing (100b) and maintains the second position.
  • the distance between the distal end of the locking member (900b) and the distal end of the locking hole (222b) becomes minimum, and the distance between the proximal end of the locking member (900b) and the proximal end of the locking hole (222b) becomes maximum.
  • the proximal end of the locking hole (222b) moves further in the base direction, the proximal end of the flexible element (130b) of the housing (100b) is further spread outward in the radial direction and inserted into the locking hole (222b) of the activating member (200b).
  • the flexible element (130b) and the locking hole (222b) interfere with each other, thereby limiting the movement of the activation member (200b), and preventing the injection needle (720) from being exposed to the outside.
  • FIG. 18 is a cross-sectional view illustrating a locking member and a flexible element of an automatic drug injection device according to a third embodiment
  • FIG. 19 is a perspective view illustrating a drug holder of an automatic drug injection device according to the third embodiment.
  • the flexible element (732c) formed in the drug holder (730c) is also cut in a T-shape so that the proximal end spreads outward in a radial direction when the locking member (900b) moves from the first position to the second position, and the proximal end is a free end and the distal end is a fixed end.
  • FIG. 20 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fourth embodiment.
  • the length of the locking hole (222b) must be longer than the length of the locking member (900d).
  • the length of the locking hole (222b) must be greater than or equal to the sum of the length of the locking member (900d) and the distance that the locking member (900d) moves from the first position to the second position.
  • the third embodiment additionally provides a fixing element for fixing the locking member (900d) in the first position.
  • the locking member (900d) has a recessed portion (930d) at a position where it comes into contact with the flexible element (130), and the flexible element (130b) is inserted into the recessed portion (930d) to restrict movement of the locking member (900b).
  • the recessed portion (930d) is not completely locked with the proximal end of the flexible element (130b) to prevent movement of the locking member (900d), and the depth of the recessed portion (930d) is formed shallow so that the flexible element (130b) can move out of the recessed portion (930d) when an external force is applied to the activating member (200b).
  • FIG. 21 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fifth embodiment.
  • the fifth embodiment also has a fixing element for fixing the locking member (900e) in the first position, but the formation position and shape of the fixing element are somewhat different from those of the third embodiment.
  • the fixing element is a projection (930e) formed on the surface where the locking member (900e) comes into contact with the housing (100e)
  • the housing (100e) has a concave portion (150e) that accommodates the projection (930e).
  • the housing (100e) does not have the concave portion (150e)
  • the protruding height of the concave portion (150e) is higher than the gap between the locking member (900e) and the inner surface of the housing (100e)
  • the locking member (900e) can be prevented from being disengaged from the first position due to interference between the projection (930e) and the housing (100e).

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Abstract

An embodiment provides an automated medication injection device comprising: a trigger module for activating a plunger by the movement of an activation member; a locking member installed in the locking hole of the activation member so as to be moved from a first position to a second position by the movement of the activation member and then retained in a housing; and a flexible element having a proximal end that spreads radially outward when the locking member is moved from the first position to the second position, wherein when the activation member is moved to the initial position, the locking hole of the activation member and the proximal end of the flexible element are locked to each other, thereby finally locking the activation member.

Description

자동 약물 주입 장치Automatic drug injection device
실시예는 자동 약물 주입 장치에 관한 것이다. The embodiment relates to an automatic drug injection device.
당뇨병과 같이 지속적인 관리가 필요한 만성 질병이나, 알러지 환자의 과민성 쇼크와 같이 즉각적인 대처가 필요한 급성 발작의 경우 병원을 방문하지 않고 사용자가 스스로 주사액을 주입할 수 있는 자가 주사기가 널리 사용되고 있다. In cases of chronic diseases such as diabetes that require continuous management, or acute attacks such as anaphylactic shock in allergy patients that require immediate response, autoinjectors that allow users to inject themselves without visiting a hospital are widely used.
휴대하고 다니다가 조건에 맞는 주사 주입 위치에 찔러넣으면 자동으로 바늘이 근육으로 삽입되고, 주사액이 스프링 등의 장치에 의해 자동으로 주입될 수 있는 펜 니들 형태의 오토 인젝터가 개발되어 널리 사용되고 있다. A pen needle-type auto injector has been developed and is widely used, which can be carried around and inserted into an appropriate injection location, automatically inserting the needle into the muscle and automatically injecting the injection liquid by a spring or other device.
그런데 종래 오토 인젝터의 경우, 약물의 주입 시작 여부나 약물의 주입이 완료되었는지 여부를 알 수가 없다는 문제점이 있었다. 또한 약물 주입이 완료된 후 사용자의 신체로부터 뽑아내었을 때, 오토 인젝터의 바늘이 외부로 노출되어 있다는 단점이 있었다. However, in the case of conventional auto injectors, there was a problem in that it was impossible to know whether the drug injection had started or whether the drug injection was complete. In addition, there was a disadvantage in that when the auto injector needle was pulled out from the user's body after the drug injection was complete, it was exposed to the outside.
이런 문제점을 해결하기 위해, 주사액의 주입이 완료된 후 주사 바늘을 락킹하는 구조나, 주사액의 주입 상황을 알려줄 수 있는 피드백 구조를 가지는 오토 인젝터가 다수 개발되었다. To solve this problem, many auto injectors have been developed that have a structure that locks the injection needle after injection of the injection liquid is completed, or a feedback structure that can inform the injection status of the injection liquid.
대한민국 등록특허 제10-2059765호에는 자동 피드백 기구를 구비하는 약물 주입 장치가 개시되어 있다. Korean Patent No. 10-2059765 discloses a drug injection device having an automatic feedback mechanism.
도 1을 참조하면, 종래 기술에 따른 약물 전달 장치(1)는 근위 단부(3a) 쪽으로 바이어스되도록 배치된 플런저 로드(11)와, 플런저(13)와, 기단 방향에서 플런저 로드(11)를 바이어스시키도록 배치되며 예를 들어 스프링일 수 있는 제 1 탄성 부재, 즉 에너지 축적 부재(15)와, 기단 방향에서 약물 전달 부재 커버(7)를 바이어스시키도록 배치된 제 2 탄성 부재 또는 에너지 축적 부재(9)와, 플런저 로드(11) 및 제 1 에너지 축적 부재(15)를 수용하도록 배치된 관형 회전자(17)와, 하우징(3)에 대해 축방향으로 및 회전방향으로 고정된 관형 연장 부재(5)와, 후방 단부 캡(7)의 일부분 및 플런저 로드(11)를 수용하도록 배치되며 하기에서 관형 회전자(17)라고 불리는 관형 작동 부재(17)와, 제 1 에너지 축적 부재(15)를 수용하도록 배치되어 있는 로드(19)와, 이후에 "U-브래킷"이라 불려지는 U-형상 브래킷으로 이후에 예시되는 신호 발생 부재(21)를 더 포함한다. 예시된 약물 전달 장치(1)는 약물 용기 홀더(23) 및 니들(25a)이 제공된 약물 용기(25)를 더 포함한다. 플런저(13)는 플런저 로드(11)의 선형 변위에 의해 약물 용기(25) 내를 주행하여, 니들(25a)을 통해 약물을 방출하도록 배치된다. Referring to FIG. 1, a drug delivery device (1) according to the prior art comprises a plunger rod (11) arranged to be biased toward the proximal end (3a), a plunger (13), a first elastic member, i.e., an energy accumulation member (15), which may be, for example, a spring, arranged to bias the plunger rod (11) in the proximal direction, a second elastic member or energy accumulation member (9) arranged to bias the drug delivery member cover (7) in the proximal direction, a tubular rotor (17) arranged to receive the plunger rod (11) and the first energy accumulation member (15), a tubular extension member (5) axially and rotationally fixed to the housing (3), a tubular operating member (17) arranged to receive a portion of the rear end cap (7) and the plunger rod (11) and referred to as a tubular rotor (17) hereinafter, and arranged to receive the first energy accumulation member (15). It further comprises a signal generating member (21) hereinafter exemplified as a U-shaped bracket, hereinafter referred to as a "U-bracket", and a rod (19). The exemplified drug delivery device (1) further comprises a drug container holder (23) and a drug container (25) provided with a needle (25a). The plunger (13) is arranged to travel within the drug container (25) by linear displacement of the plunger rod (11) to discharge the drug through the needle (25a).
플런저 로드(11), 관형 연장 부재(5), 관형 작동 부재(17), 에너지 축적 부재(15) 및 신호 발생 부재(21)는 약물 전달 장치(1)에 대한 자동 피드백 기구 또는 단순히 피드백 기구를 형성한다. 피드백 기구는 사용자에게 약물 용기(25)로부터의 약물의 방출의 시작을 알리도록 배치된다. The plunger rod (11), the tubular extension member (5), the tubular actuating member (17), the energy accumulating member (15) and the signal generating member (21) form an automatic feedback mechanism or simply a feedback mechanism for the drug delivery device (1). The feedback mechanism is arranged to notify the user of the start of the discharge of the drug from the drug container (25).
사용하기 전에, 플런저 로드는 초기 위치에서 축방향으로 고정되어 배치된다. 약물 전달 장치가 작동될 때, 즉 사용자가 약물 전달을 개시할 때, 플런저 로드는 초기 위치로부터 해제되고, 에너지 축적 부재에 의해 기단 방향으로 가압된다. 플런저 로드가 약물 방출의 개시를 위해 필요한 거리에 대응하는 거리만큼 변위되면, 플런저 로드의 제 1 섹션과 신호 발생 부재 사이의 접촉이 중단될 것이다. 따라서, 플런저 로드와 신호 발생 부재는, 플런저 로드의 초기 위치에서의 제 1 섹션 및 신호 발생 부재의 축방향 중첩이 상기 거리와 동일하거나 또는 상기 거리와 실질적으로 동일하게 되도록 설계된다. 따라서, 제 1 섹션은 약물 방출의 개시를 위해 필요한 거리에 대응하는 플런저 로드 거리의 축방향 변위 동안에 신호 발생 부재만을 지지한다. 플런저 로드가 이러한 거리에 대응하는 양만큼 변위되면, 신호 발생 부재는 그 반경방향으로 바이어스되지 않은 상태로 반경방향 내측으로 구부러질 것이다. 이에 의해, 신호 발생 부재는 관형 연장 부재로부터 분리될 것이다. 따라서, 제 1 에너지 축적 부재에 의해 원위 방향으로 바이어스된 신호 발생 부재는 관형 연장 부재에 의해 더 이상 유지되지 않으며, 그에 따라 관형 연장 부재의 원위 내부 표면을 향하여 던져질 것이다. 이로 인해 "클릭(click)" 소리가 들리며, 또한 사용자에게 촉감을 준다.Before use, the plunger rod is positioned axially fixed in the initial position. When the drug delivery device is actuated, i.e. the user initiates drug delivery, the plunger rod is released from the initial position and is pushed proximally by the energy accumulating member. When the plunger rod is displaced by a distance corresponding to the distance required for initiation of drug release, the contact between the first section of the plunger rod and the signal generating member will cease. Accordingly, the plunger rod and the signal generating member are designed such that the axial overlap of the first section and the signal generating member at the initial position of the plunger rod is equal to or substantially equal to said distance. Accordingly, the first section only supports the signal generating member during the axial displacement of the plunger rod distance corresponding to the distance required for initiation of drug release. When the plunger rod is displaced by an amount corresponding to this distance, the signal generating member will bend radially inwardly without being biased in its radial direction. Thereby, the signal generating member will separate from the tubular extension member. Therefore, the signal generating element that was biased distally by the first energy accumulating element is no longer retained by the tubular extension element and will therefore be thrown toward the distal inner surface of the tubular extension element. This results in an audible "click" sound and also a tactile sensation to the user.
그러나 종래의 자동 약물 주입 장치의 경우, 락킹을 해제하고 플런저 로드를 작동시키기 위한 작동 부재와, 약물의 주입이 종료된 후 약물 용기 홀더를 락킹하기 위한 부재를 각각 별도로 구비함으로써, 부품수가 많아지고, 조립이 복잡하다는 단점이 있었다. However, in the case of conventional automatic drug injection devices, there were disadvantages in that the number of parts increased and assembly was complicated because the operating member for unlocking and operating the plunger rod and the member for locking the drug container holder after drug injection was completed were provided separately.
따라서, 구조를 단순화하여 부품수를 절감하고 조립이 용이한 자동 약물 주입 장치의 개발이 요구된다. Therefore, there is a need to develop an automatic drug injection device that is easy to assemble and has a simplified structure to reduce the number of parts.
실시예는, 자동 약물 주입 장치의 사용 완료 후, 주사 바늘의 노출을 방지할 수 있도록 활성화 부재의 이동을 막는 락킹 부재가 플런저의 트리거 부재 역할을 겸하여 부품 수를 절감하고 구조를 단순화할 수 있는 자동 약물 주입 장치를 제공하는 것을 목적으로 한다. The embodiment aims to provide an automatic drug injection device in which a locking member that prevents movement of an activating member to prevent exposure of an injection needle after use of the automatic drug injection device also serves as a trigger member of a plunger, thereby reducing the number of parts and simplifying the structure.
실시예는, 외관을 형성하는 튜브형 하우징; 약물을 저장하는 약물 저장부와 피부를 침습하여 약물 저장부에 저장된 약물을 주입할 수 있는 주사 바늘을 구비하며 튜브형 하우징에 고정된 약물 용기; 튜브형 하우징을 따라 슬라이드 가능하게 설치되며, 슬라이드 방향으로 형성된 수용홀을 구비하는 활성화 부재; 활성화 부재를 기단 방향으로 가압하는 제1 탄성 부재; 활성화 부재의 이동에 의해 활성화되어 약물 용기 내의 약물을 가압하는 플런저; 튜브형 하우징의 원위 단부에 설치되며, 원위 단부 측에 원주 방향을 따라 형성된 걸림턱을 구비하는 트리거 하우징; 튜브형 락킹 부재 내에 슬라이드 가능하게 설치되며, 플런저 로드 및 플런저 로드로부터 원위 방향으로 연장되며 트리거 부재의 걸림턱에 걸림되는 락킹 돌기가 형성된 복수 개의 트리거 암을 구비하는 플런저; 튜브형 하우징의 내부에 형성되며, 튜브형 몸체, 튜브형 몸체의 원위 단부에 형성되는 헤드부 및 헤드부로부터 기단 방향으로 돌출되어 트리거 암들 내측 공동에 삽입되는 안전핀을 구비하는 안전핀 모듈; 및 튜브형 트리거 하우징 내에 설치되며, 플런저를 기단 방향으로 가압하는 제2 탄성 부재;를 포함하고, 활성화 부재는, 주사 바늘의 노출을 방지하는 캡 형의 근위 단부와 근위 단부로부터 원위 방향으로 연장되는 활성화 암 및 활성화 암에 형성되는 락킹 홀을 구비하고, 활성화 부재가 원위 방향으로 슬라이드 하면서 활성화 암이 안전핀 모듈을 원위 방향으로 이동시켜 안전핀을 플런저의 트리거 암으로부터 인출하여 플런저와 안전핀 모듈의 락킹을 해제하고, 튜브형 하우징 또는 튜브형 하우징에 고정되는 부품 중 어느 하나에 형성되며, 근위 단부가 자유단이고 원위 단부가 고정단이며 근위 단부로 갈수록 더 반경 방향 외측으로 뻗어있으며, 반경 방향으로 탄성 이동이 가능한 가요성 요소를 구비하며, 활성화 부재가 초기 위치로 이동하면 활성화 부재의 수용홀과 가요성 요소의 근위 단부가 락킹되어 활성화 부재를 최종 락킹하는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.The embodiment comprises: a tubular housing forming an exterior; a drug container having a drug storage portion storing a drug and an injection needle capable of penetrating the skin to inject the drug stored in the drug storage portion, the drug container being fixed to the tubular housing; an activating member slidably installed along the tubular housing and having a receiving hole formed in a sliding direction; a first elastic member urging the activating member in a proximal direction; a plunger activated by movement of the activating member to urge the drug in the drug container; a trigger housing installed at a distal end of the tubular housing and having a catch protrusion formed along a circumferential direction on the distal end side; a plunger slidably installed within the tubular locking member and having a plunger rod and a plurality of trigger arms extending distally from the plunger rod and having locking projections formed to catch on the catch protrusions of the trigger member; a safety pin module formed inside the tubular housing and having a tubular body, a head portion formed at a distal end of the tubular body, and a safety pin protruding from the head portion in a proximal direction and inserted into an inner cavity of the trigger arms; And a second elastic member installed in the tubular trigger housing and pressurizing the plunger in the proximal direction; The activating member has a cap-shaped proximal end that prevents exposure of the injection needle, an activating arm extending distally from the proximal end, and a locking hole formed in the activating arm, and when the activating member slides distally, the activating arm moves the safety pin module distally to withdraw the safety pin from the trigger arm of the plunger and unlock the plunger and the safety pin module, and a flexible element formed in one of the tubular housing or a part fixed to the tubular housing, the proximal end being a free end and the distal end being a fixed end, and extending more radially outward as it goes toward the proximal end, and capable of elastically moving in the radial direction is provided, characterized in that when the activating member moves to the initial position, the receiving hole of the activating member and the proximal end of the flexible element are locked to finally lock the activating member.
실시예의 다른 일 태양으로서, 가요성 요소는 트리거 하우징에 형성되고, 트리거 하우징의 원위 단부는 안전핀 모듈 내에 삽입되어 있으며, 활성화 부재에 의해 안전핀 모듈이 원위 방향으로 이동하기 전에 가요성 요소는 안전핀 모듈 내에 수용되어 활성화 암의 락킹 홀과 락킹이 이루어지지 않는 비활성 상태인 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.In another aspect of the present invention, an automatic drug injection device is provided, wherein the flexible element is formed in a trigger housing, a distal end of the trigger housing is inserted into a safety pin module, and before the safety pin module is moved distally by an activating member, the flexible element is received within the safety pin module and is in an inactive state where it is not locked with a locking hole of an activating arm.
실시예의 다른 일 태양으로서, 가요성 요소는 트리거 하우징에 형성되고, 가요성 요소의 근위 단부 및 락킹 홀의 근위 단부는 활성화 부재가 원위 방향으로 이동 시에 가요성 요소의 근위 단부가 반경 방향 외측으로 슬라이드되도록 경사진 형태를 가지는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.In another aspect of the present invention, an automatic drug injection device is provided, wherein the flexible element is formed in a trigger housing, and a proximal end of the flexible element and a proximal end of the locking hole have an inclined shape such that the proximal end of the flexible element slides radially outward when the activating member moves in a distal direction.
실시예의 다른 일 태양으로서, 활성화 암의 원위 단부로부터 안전핀 모듈의 헤드부의 근위 단부까지의 거리가, 락킹 홀의 근위 단부로부터 안전핀 모듈의 튜브형 몸체의 근위 단부까지의 거리보다 더 긴 것을 특징으로 하는 자동 약물 주입 장치를 제공한다. In another aspect of the present invention, an automatic drug injection device is provided, characterized in that a distance from a distal end of an activating arm to a proximal end of a head portion of a safety pin module is longer than a distance from a proximal end of a locking hole to a proximal end of a tubular body of the safety pin module.
실시예의 다른 일 태양으로서, 활성화 부재의 수용홀 내에 설치되며, 활성화 부재의 이동에 의해 제1 위치에서 제2 위치로 이동한 뒤 튜브형 하우징에 고정되는 잠금 부재;를 더 포함하고, 가요성 요소는 잠금 부재가 제1 위치에서 제2 위치로 이동하면 근위 단부가 반경 방향 외측으로 벌어지는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.As another aspect of the embodiment, an automatic drug injection device is provided, further comprising a locking member installed in a receiving hole of an activating member and fixed to a tubular housing after moving from a first position to a second position by movement of the activating member; wherein the flexible element is characterized in that a proximal end thereof spreads radially outward when the locking member moves from the first position to the second position.
실시예의 다른 일 태양으로서, 잠금 부재와 튜브형 하우징은 잠금 요소를 구비하며, 잠금 부재가 제2 위치로 이동하면 잠금 부재와 튜브형 하우징의 잠금 요소가 서로 맞물리는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.In another aspect of the invention, an automatic drug injection device is provided, wherein the locking member and the tubular housing have locking elements, and when the locking member moves to the second position, the locking elements of the locking member and the tubular housing are engaged with each other.
실시예의 다른 일 태양으로서, 가요성 요소는 튜브형 하우징에 형성되는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.As another aspect of the embodiment, an automatic drug injection device is provided, characterized in that the flexible element is formed in a tubular housing.
실시예의 다른 일 태양으로서, 약물 용기를 튜브형 하우징에 고정하는 약물 홀더;를 더 포함하며, 가요성 요소는 약물 홀더에 형성되는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.As another aspect of the embodiment, an automatic drug injection device is provided, further comprising a drug holder for fixing a drug container to a tubular housing; wherein the flexible element is formed on the drug holder.
실시예의 다른 일 태양으로서, 활성화 부재에 형성된 락킹 홀의 길이는, 잠금 부재의 길이와 잠금 부재가 제1 위치에서 제2 위치로 이동한 거리의 합보다 크거나 같은 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.In another aspect of the present invention, an automatic drug injection device is provided, characterized in that the length of a locking hole formed in an activating member is greater than or equal to the sum of the length of the locking member and the distance the locking member moves from a first position to a second position.
실시예의 다른 일 태양으로서, 활성화 부재가 플런저를 활성화하기 전, 잠금 부재의 위치를 제1 위치에 고정하기 위한 안착 요소;를 더 포함하는 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.As another aspect of the embodiment, an automatic drug injection device is provided, characterized in that it further includes a securing element for fixing the position of the locking element in the first position before the activating element activates the plunger.
실시예의 다른 일 태양으로서, 안착 요소는 가요성 요소의 근위 단부 및 잠금 부재에 형성되며 가요성 요소의 근위 단부가 안착되는 오목부인 것을 특징으로 하는 자동 약물 주입 장치를 제공한다. In another aspect of the present invention, an automatic drug injection device is provided, wherein the securing element is formed on a proximal end of a flexible element and a locking member, and is characterized by a concave portion in which the proximal end of the flexible element is secured.
실시예의 다른 일 태양으로서, 안착 요소는 잠금 부재에 형성되는 돌기 또는 오목부와, 하우징에 형성되며 잠금 부재의 돌기가 수용되는 오목부 또는 잠금 부재의 오목부에 수용되는 돌기인 것을 특징으로 하는 자동 약물 주입 장치를 제공한다.In another aspect of the present invention, an automatic drug injection device is provided, characterized in that the securing element is a projection or a recess formed on a locking member, and a recess formed on a housing and configured to receive the projection of the locking member or a projection received in the recess of the locking member.
실시예가 제공하는 자동 약물 주입 장치는 락킹 부재가 플런저를 락킹 및 락킹 해제하는 트리거 역할과, 약물 주입 완료 후 활성화 부재를 락킹하여 주사 바늘의 노출을 방지하는 락킹 부재를 겸하도록 함으로써, 부품수를 절감하고 구조를 단순화할 수 있다는 장점이 있다. The automatic drug injection device provided by the embodiment has the advantage of reducing the number of parts and simplifying the structure by having the locking member function as a trigger for locking and unlocking the plunger and the locking member for locking the activation member after drug injection is completed to prevent exposure of the injection needle.
도 1은 종래 기술에 따른 자동 피드백 기구를 구비하는 약물 주입 장치를 도시한 도면,Figure 1 is a drawing showing a drug injection device having an automatic feedback mechanism according to the prior art;
도 2는 제1 실시예에 따른 자동 약물 주입 장치를 도시한 분해도, Figure 2 is an exploded view showing an automatic drug injection device according to the first embodiment;
도 3은 제1 실시예에 따른 자동 약물 주입 장치를 도시한 단면도,Figure 3 is a cross-sectional view illustrating an automatic drug injection device according to the first embodiment;
도 4는 제1 실시예에 따른 자동 약물 주입 장치가 구비하는 트리거 하우징의 가요성 요소가 비활성화 및 활성화된 상태를 도시한 사시도,FIG. 4 is a perspective view showing a state in which a flexible element of a trigger housing provided in an automatic drug injection device according to the first embodiment is deactivated and activated;
도 5는 제1 실시예에 따른 자동 약물 주입 장치의 트리거 모듈의 해제 전 원위 단부의 모습을 도시한 단면도, Figure 5 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment before release;
도 6는 제1 실시예에 따른 자동 약물 주입 장치의 트리거 모듈의 해제 직후 원위 단부의 모습을 도시한 단면도, FIG. 6 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment immediately after release;
도 7은 제1 실시예에 따른 자동 약물 주입 장치의 트리거 하우징가 활정화 부재와 락킹된 이후 원위 단부의 모습을 도시한 단면도.FIG. 7 is a cross-sectional view showing the distal end of the trigger housing of the automatic drug injection device according to the first embodiment after it has been locked with the activating member.
도 8는 제2 실시예에 따른 자동 약물 주입 장치를 도시한 분해도, Figure 8 is an exploded view showing an automatic drug injection device according to the second embodiment;
도 9은 제2 실시예에 따른 자동 약물 주입 장치를 도시한 분해 단면도, Figure 9 is an exploded cross-sectional view showing an automatic drug injection device according to the second embodiment;
도 10는 제2 실시예에 따른 자동 약물 주입 장치의 하우징을 도시한 단면 사시도, FIG. 10 is a cross-sectional perspective view showing a housing of an automatic drug injection device according to the second embodiment;
도 11는 제2 실시예에 따른 자동 약물 주입 장치의 활성화 부재를 도시한 사시도, FIG. 11 is a perspective view showing an activation member of an automatic drug injection device according to a second embodiment;
도 12은 제2 실시예에 따른 자동 약물 주입 장치의 잠금 부재를 도시한 사시도, FIG. 12 is a perspective view showing a locking member of an automatic drug injection device according to the second embodiment;
도 13은 제2 실시예에 따른 자동 약물 주입 장치의 초기 상태를 도시한 단면도, Fig. 13 is a cross-sectional view showing the initial state of an automatic drug injection device according to the second embodiment;
도 14은 제2 실시예에 따른 자동 약물 주입 장치의 트리거 해제 시작 시 모습을 도시한 단면도, Figure 14 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment at the start of trigger release.
도 15은 제2 실시예에 따른 자동 약물 주입 장치의 트리거 해제 후 모습을 도시한 단면도, Figure 15 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after the trigger is released.
도 16은 제2 실시예에 따른 자동 약물 주입 장치의 약물 주입 완료 후 모습을 도시한 단면도, Figure 16 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after drug injection is completed.
도 17은 제2 실시예에 따른 자동 약물 주입 장치의 활성화 부재가 초기 위치로 복귀 후 최종 락킹된 모습을 도시한 단면도, Figure 17 is a cross-sectional view showing the final locked state after the activation member of the automatic drug injection device according to the second embodiment returns to the initial position.
도 18는 제3 실시예에 따른 자동 약물 주입 장치의 잠금 부재와 가요성 요소를 도시한 단면도, FIG. 18 is a cross-sectional view showing a locking member and a flexible element of an automatic drug injection device according to a third embodiment;
도 19은 제3 실시예에 따른 자동 약물 주입 장치의 약물 홀더를 도시한 사시도, Fig. 19 is a perspective view showing a drug holder of an automatic drug injection device according to the third embodiment.
도 20는 제4 실시예에 따른 자동 약물 주입 장치의 잠금 부재 안착 요소를 도시한 도면, FIG. 20 is a drawing showing a locking member fixing element of an automatic drug injection device according to the fourth embodiment;
도 21는 제5 실시예에 따른 자동 약물 주입 장치의 잠금 부재 안착 요소를 도시한 도면.FIG. 21 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fifth embodiment.
이하, 도면을 참조하여 제1 실시예를 더욱 상세하게 설명한다. 그러나, 본 발명의 개념은 많은 상이한 형태로 구현될 수 있으며, 여기에 개시된 제1 실시예로 제한되어서는 안되며, 오히려 이들 제1 실시예는, 본 개시가 철저하고 완전하며 당업자들에게 본 발명의 개념의 범위를 충분히 전달할 수 있도록 예로서 제공된다.Hereinafter, a first embodiment will be described in more detail with reference to the drawings. However, the concept of the present invention may be implemented in many different forms and should not be limited to the first embodiment disclosed herein; rather, these first embodiments are provided by way of example so that this disclosure will be thorough and complete and will sufficiently convey the scope of the concept of the present invention to those skilled in the art.
본 명세서에서 사용된 바와 같이 용어 "근위 단부"는 약물 방출이 제공될 수 있는 약물 전달 장치의 그 단부를 지칭한다. 따라서, 이는 주사 또는 방출 부위를 향해 뾰족해지는 약물 전달 장치의 그 단부이다. 이러한 정의는 또한, 약물 전달 장치의 임의의 내부 또는 외부 구성요소까지 확장하는데, 즉, 임의의 구성요소의 근위 단부는 약물 전달 장치의 근위 단부에 가장 가까운 단부이다. "원위 단부"는 근위 단부에 대해 반대쪽 단부이다. As used herein, the term "proximal end" refers to that end of a drug delivery device from which drug release can be provided. Thus, it is that end of the drug delivery device that is tapered toward an injection or release site. This definition also extends to any internal or external component of the drug delivery device, i.e., the proximal end of any component is the end closest to the proximal end of the drug delivery device. The "distal end" is the end opposite the proximal end.
"기단 방향"이란 약물 전달 장치의 중심축을 따라 원위 단부로부터 근위 단부를 향하는 방향을 의미한다. "원위 방향"이란 "기단 방향"과 반대 방향을 의미한다."Proximal direction" means the direction from the distal end to the proximal end along the central axis of the drug delivery device. "Distal direction" means the direction opposite to "proximal direction."
도 2는 제1 실시예에 따른 자동 약물 주입 장치를 도시한 분해도, 도 3은 제1 실시예에 따른 자동 약물 주입 장치를 도시한 단면도이다. FIG. 2 is an exploded view illustrating an automatic drug injection device according to the first embodiment, and FIG. 3 is a cross-sectional view illustrating an automatic drug injection device according to the first embodiment.
제1 실시예에 따른 자동 약물 주입 장치는, 외관을 형성하는 튜브형 하우징(100)을 구비하고, 튜브형 하우징(100)의 근위 단부 측에는 내에 축 방향으로 슬라이드 가능하게 설치되 활성화 부재(200)와, 활성화 부재(200)를 기단 방향으로 가압하는 제1 탄성 부재(300)를 포함한다. 활성화 부재(200)의 근위 단부(210)는 약물 주입 전 튜브형 하우징(100)의 근위 단부 밖으로 노출되어 있다. An automatic drug injection device according to a first embodiment comprises a tubular housing (100) forming an outer appearance, an activating member (200) slidably installed in the axial direction on the proximal end side of the tubular housing (100), and a first elastic member (300) that presses the activating member (200) in the proximal direction. The proximal end (210) of the activating member (200) is exposed outside the proximal end of the tubular housing (100) before drug injection.
또한 튜브형 하우징(100)의 원위 단부에는 트리거 하우징(500)가 설치된다. 트리거 하우징(500)는 내에는 플런저(400)가 슬라이드 가능하게 설치된다. Additionally, a trigger housing (500) is installed at the distal end of the tubular housing (100). A plunger (400) is slidably installed inside the trigger housing (500).
제2 탄성 부재(600)가 트리거 하우징(500)와 플런저(400) 사이에 설치되며, 제2 탄성 부재(600)는 플런저(400)를 기단 방향으로 가압할 수 있도록 압축된 상태로 설치된다. A second elastic member (600) is installed between the trigger housing (500) and the plunger (400), and the second elastic member (600) is installed in a compressed state so as to pressurize the plunger (400) in the proximal direction.
활성화 부재(200)가 원위 방향으로 슬라이드되어 자동 약물 주입 장치를 활성화시키기 전까지는 플런저(400)는 제2 탄성 부재(600)의 압력이 작용하는 상태에서도 기단 방향으로 이동하지 않도록 락킹이 이루어져 있다. The plunger (400) is locked so that it does not move in the proximal direction even when pressure from the second elastic member (600) is applied until the activation member (200) slides distally to activate the automatic drug injection device.
활성화 부재(200)는 근위 단부(210)는 튜브형으로 근위 단부(210)의 말단에는 사용자의 피부에 접촉하는 접촉면을 구비한다. 접촉면의 중앙에는 홀이 구비되어 활성화 부재(200)의 후퇴 시에 주사 바늘(720)이 홀을 통해 노출된다. The activation member (200) has a tubular proximal end (210) and a contact surface at the end of the proximal end (210) that comes into contact with the user's skin. A hole is provided in the center of the contact surface, and when the activation member (200) is retracted, an injection needle (720) is exposed through the hole.
활성화 부재(200)는 근위 단부(210)로부터 원위 방향으로 연장되는 활성화 암(220)를 더 포함한다. 활성화 암(220)에는 활성화 부재(200)의 최종 락킹을 위한 락킹 홀(222;도 5 참조)이 형성된다. The activating member (200) further includes an activating arm (220) extending distally from the proximal end (210). A locking hole (222; see FIG. 5) for final locking of the activating member (200) is formed in the activating arm (220).
플런저(400)를 락킹 및 락킹 해제하는 트리거 모듈은 플런저(400), 트리거 하우징(500), 제2 탄성 부재(600)로 이루어지며, 트리거 모듈은 안전핀 모듈(800)의 안전핀(830)이 해제되어야 작동한다. The trigger module for locking and unlocking the plunger (400) is composed of a plunger (400), a trigger housing (500), and a second elastic member (600), and the trigger module operates only when the safety pin (830) of the safety pin module (800) is released.
플런저(400)는, 후술할 약물 용기(710) 내로 슬라이드 하며 약액을 주입하하는 플런저 로드(410)와, 플런저 로드(410)의 원위 단부로부터 원위 방향으로 연장되는 복수 개의 트리거 암(420)을 구비한다. 복수 개의 트리거 암(420)은 플런저 로드(410)의 원위 단부의 외주를 따라 서로 간격을 두고 형성되며, 트리거 암(420)들의 중앙에는 공동이 형성된다. 공동 내로는 후술할 안전핀 모듈(800)의 안전핀(830)이 삽입된다. 트리거 암(420)의 원위 단부에는 화살촉 모양의 락킹 돌기(422)가 형성된다. The plunger (400) has a plunger rod (410) that slides into a drug container (710) to be described later and injects a drug solution, and a plurality of trigger arms (420) that extend in a distal direction from a distal end of the plunger rod (410). The plurality of trigger arms (420) are formed at intervals from each other along the outer periphery of the distal end of the plunger rod (410), and a cavity is formed in the center of the trigger arms (420). A safety pin (830) of a safety pin module (800) to be described later is inserted into the cavity. An arrowhead-shaped locking protrusion (422) is formed at the distal end of the trigger arm (420).
트리거 하우징(500)는 앞서 설명한 바와 같이 튜브형의 몸체(510)를 구비하며, 원위 단부측에 몸체(510)의 내주면을 따라 링 형상의 걸림턱(520)이 형성된다. The trigger housing (500) has a tubular body (510) as described above, and a ring-shaped catch (520) is formed along the inner surface of the body (510) at the distal end.
안전핀 모듈(800)은 튜브형 하우징(100)의 원위 단부에 결합된다. 안전핀 모듈(800)은 튜브형 몸체(810), 튜브형 몸체(810)의 원위 단부에 형성되는 헤드부(820) 및 헤드부(820)로부터 기단 방향으로 돌출되어 트리거 암(420)들 내측 공동에 삽입되는 안전핀(830)을 구비한다. A safety pin module (800) is coupled to the distal end of the tubular housing (100). The safety pin module (800) has a tubular body (810), a head portion (820) formed at the distal end of the tubular body (810), and a safety pin (830) protruding from the head portion (820) in a proximal direction and inserted into an inner cavity of the trigger arms (420).
트리거 하우징(500)는 튜브형 하우징(100)에 고정된 상태로, 트리거 하우징(500)의 원위 단부는 안전핀 모듈(800) 내, 즉, 튜브형 몸체(810) 내에 위치한다. The trigger housing (500) is fixed to the tubular housing (100), and the distal end of the trigger housing (500) is located within the safety pin module (800), i.e., within the tubular body (810).
트리거 암(420)의 락킹 돌기(422)는 안전핀(830)이 삽입되면 반경 방향 외측으로 벌어지게 되고, 트리거 하우징(500)의 걸림턱(520)과 락킹이 이루어진다. 안전핀 모듈(800)의 안전핀(830)이 트리거 암(420)들 사이의 공동으로부터 제거되지 않는한 트리거 하우징(500)와 트리거 암(420)의 락킹이 해제되지 않는다. 이때, 트리거 암(420)은 반경 방향으로 탄성적으로 이동 가능한 것이 바람직하며, 안전핀(830)이 트리거 암(420)들의 중간으로 삽입되지 않은 경우, 락킹 돌기(422)의 돌출 반경이 트리거 하우징(500)의 걸림턱(520) 내주면 지름보다 작은 것이 바람직하다. 그에 따라 안전핀(830)이 제거되면, 트리거 암(420)이 원 위치로 이동하면서 걸림턱(520)과 락킹 돌기(422)의 락킹이 쉽게 해제된다. The locking projection (422) of the trigger arm (420) is spread outward in the radial direction when the safety pin (830) is inserted, and is locked with the catch (520) of the trigger housing (500). The locking of the trigger housing (500) and the trigger arm (420) is not released unless the safety pin (830) of the safety pin module (800) is removed from the cavity between the trigger arms (420). At this time, it is preferable that the trigger arm (420) is elastically movable in the radial direction, and when the safety pin (830) is not inserted into the middle of the trigger arms (420), it is preferable that the protruding radius of the locking projection (422) is smaller than the inner diameter of the catch (520) of the trigger housing (500). Accordingly, when the safety pin (830) is removed, the trigger arm (420) moves to the original position, and the locking of the catch (520) and the locking projection (422) is easily released.
튜브형 하우징(100)에는 약물을 저장하는 약물 저장부(710)와 약물 저장된 약물을 주입하기 위한 주사 바늘(720)을 구비하는 약물 용기(700)가 설치된다. 약물 용기(700)는, 활성화 부재(200)나 플런저(400)의 이동과 무관하게 튜브형 하우징(100)에 위치가 고정된 상태를 유지한다. A drug container (700) having a drug storage section (710) for storing a drug and an injection needle (720) for injecting the drug stored in the tubular housing (100) is installed in the tubular housing (100). The drug container (700) maintains a fixed position in the tubular housing (100) regardless of movement of the activating member (200) or the plunger (400).
이때 플런저(400)의 근위 단부는 약물 저장부(710) 내에 소정 깊이 삽입된 상태로 조립되어, 제2 탄성 부재(600)가 플런저(400)를 가압할 때 약물 저장부(710) 내에서 플런저(400)가 근위 방향으로 이동하면서 약물이 주사 바늘(720)을 통해 사용자의 체내로 주입된다. At this time, the proximal end of the plunger (400) is assembled in a state of being inserted into the drug storage unit (710) to a predetermined depth, so that when the second elastic member (600) presses the plunger (400), the plunger (400) moves in the proximal direction within the drug storage unit (710), and the drug is injected into the user's body through the injection needle (720).
도 4은 제1 실시예에 따른 자동 약물 주입 장치가 구비하는 트리거 하우징의 가요성 요소가 비활성화 및 활성화된 상태를 도시한 사시도이다. FIG. 4 is a perspective view showing a flexible element of a trigger housing of an automatic drug injection device according to the first embodiment in a deactivated and activated state.
제1 실시예에 따른 트리거 하우징(500)은 가요성 요소(530)를 구비하여 플런저(400)의 락킹 및 락킹 해제를 위한 트리거 역할을 하는 동시에 자동 약물 주입 장치의 사용이 끝난 후 주사 바늘의 노출을 방지하기 위해 활성화 부재(200)의 이동을 방지하는 최종 락킹을 수행하는 역할을 겸한다. The trigger housing (500) according to the first embodiment has a flexible element (530) that acts as a trigger for locking and unlocking the plunger (400) and also performs a final locking function to prevent movement of the activating member (200) to prevent exposure of the injection needle after use of the automatic drug injection device is finished.
트리거 하우징(500)은 원통형 몸체(510)를 구비하며, 원통형 몸체(510)를 절개하여 형성되며, 근위 단부가 자유단이고 원위 단부가 고정단이며 근위 단부가 반경 방향으로 탄성 이동이 가능한 가요성 요소(530)를 구비한다. 이때 가요성 요소(530)는 근위 단부로 갈수록 더 반경 방향 외측으로 돌출되는 것이 바람직하다. 외력이 가해지지 않은 상태에서는, 가요성 요소(530)의 근위 단부는 활성화 부재(200; 도 4 참조)의 외주면보다 더 반경방향 외측까지 돌출되어 있는 것이 바람직하다. The trigger housing (500) has a cylindrical body (510), and is formed by cutting the cylindrical body (510), and has a flexible element (530) whose proximal end is a free end, its distal end is a fixed end, and its proximal end is elastically movable in the radial direction. At this time, it is preferable that the flexible element (530) protrudes more radially outwardly toward the proximal end. When no external force is applied, it is preferable that the proximal end of the flexible element (530) protrudes more radially outwardly than the outer surface of the activating member (200; see FIG. 4).
도 5는 제1 실시예에 따른 자동 약물 주입 장치의 트리거 모듈의 해제 전 원위 단부의 모습을 도시한 단면도, 도 6은 제1 실시예에 따른 자동 약물 주입 장치의 트리거 모듈의 해제 직후 원위 단부의 모습을 도시한 단면도이다. FIG. 5 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment before release, and FIG. 6 is a cross-sectional view showing the distal end of the trigger module of the automatic drug injection device according to the first embodiment immediately after release.
앞서 설명한 바와 같이 활성화 부재(200)가 원위 방향으로 이동하면, 활성화 암(220)이 안전핀 모듈(800)의 헤드부(810)를 원위 방향으로 밀면서 안전핀(830)이 해제되고 트리거 모듈이 작동하게 된다. 안전핀(830)이 제거되고, 트리거 암(420)의 락킹 돌기(422)가 반경 방향 내측으로 이동하면서 트리거 하우징(500)의 걸림턱(520)과의 락킹이 쉽게 해제된다. As described above, when the activation member (200) moves distally, the activation arm (220) pushes the head (810) of the safety pin module (800) distally, thereby releasing the safety pin (830) and operating the trigger module. The safety pin (830) is removed, and the locking projection (422) of the trigger arm (420) moves radially inward, thereby easily releasing the locking with the engaging projection (520) of the trigger housing (500).
한편, 활성화 부재(200)가 원위 방향으로 이동하기 전까지는 트리거 하우징(500)의 가요성 요소(530)가 탄성 압축된 상태로 안전핀 모듈(800)의 튜브형 몸체(810) 내에 수용되어 있다가, 활성화 부재(200)의 활성화 암(220)이 안전핀 모듈(800)을 원위 방향으로 이동시킴으로써, 가요성 요소(530)이 튜브형 몸체(810)로부터 빠져나온다. Meanwhile, until the activating member (200) moves distally, the flexible element (530) of the trigger housing (500) is accommodated in the tubular body (810) of the safety pin module (800) in an elastically compressed state, and then, when the activating arm (220) of the activating member (200) moves the safety pin module (800) distally, the flexible element (530) comes out of the tubular body (810).
압축되어 있던 제2 탄성 부재(600)의 복원력에 의해 플런저(400)는 기단 방향으로 가압력을 받게 되는데, 그에 따라 플런저(400)가 약물 저장부(710; 도 3 참조) 내에서 기단 방향으로 이동하며 약액을 가압하여 주사 바늘을 통해 사용자의 신체 내로 주입되도록 한다. The plunger (400) is pressurized in the base direction by the restoring force of the second elastic member (600) that was compressed, and accordingly, the plunger (400) moves in the base direction within the drug storage unit (710; see FIG. 3) and pressurizes the drug solution so that it is injected into the user's body through the injection needle.
한편, 활성화 부재(200)가 사용자의 신체에 밀착되어 가압된 상태에서, 즉 활성화 부재(200)에 외력이 가해져 원위 방향으로 이동한 상태에서는 활성화 부재(200)의 활성화 암(220)에 형성된 락킹 홀(222)의 근위 단부가 가요성 요소(530)의 근위 단부보다 더 원위에 위치한다. Meanwhile, when the activation member (200) is pressed against the user's body, that is, when an external force is applied to the activation member (200) and moves in a distal direction, the proximal end of the locking hole (222) formed in the activation arm (220) of the activation member (200) is located further distally than the proximal end of the flexible element (530).
또한, 활성화 부재(200)의 활성화 암(220)의 원위 단부로부터 안전핀 모듈(830)의 헤드부(810)의 근위 단부까지의 거리가, 활성화 암(220)에 형성된 락킹 홀(222)의 근위 단부로부터 안전핀 모듈(800)의 튜브형 몸체(810)의 근위 단부까지의 거리가 더 길다. 따라서, 활성화 부재(200)가 안전핀 모듈(800)의 안전핀(830)을 트리거 모듈로부터 제거하기 전에 락킹 홀(222)이 튜브형 몸체(810)에 의해 가려져 가요성 요소(530)과의 락킹이 이루어지지 않는다. In addition, the distance from the distal end of the activation arm (220) of the activation member (200) to the proximal end of the head portion (810) of the safety pin module (830) is longer than the distance from the proximal end of the locking hole (222) formed in the activation arm (220) to the proximal end of the tubular body (810) of the safety pin module (800). Therefore, before the activation member (200) removes the safety pin (830) of the safety pin module (800) from the trigger module, the locking hole (222) is covered by the tubular body (810), and locking with the flexible element (530) is not achieved.
즉, 트리거 하우징(500)의 가요성 요소(530)은 튜브형 몸체(810)로부터 빠져나와 락킹 동작이 가능한 상태이나 락킹 홀(222)과의 락킹은 이루어지지 않은 상태이다. 즉, 트리거 하우징(500)는 락킹이 가능하도록 활성화되었으나 락킹이 된 상태는 아니다. That is, the flexible element (530) of the trigger housing (500) is pulled out of the tubular body (810) and is capable of locking, but is not locked with the locking hole (222). That is, the trigger housing (500) is activated to enable locking, but is not in a locked state.
도 7은 제1 실시예에 따른 자동 약물 주입 장치의 트리거 하우징가 활정화 부재와 락킹된 이후 원위 단부의 모습을 도시한 단면도이다. FIG. 7 is a cross-sectional view showing the distal end of the trigger housing of the automatic drug injection device according to the first embodiment after it is locked with the activating member.
약액의 주입을 마치고, 활성화 부재(200)를 사용자의 신체로부터 떼어내면, 활성화 부재(200)에 가해지던 외력이 사라져, 제1 탄성 부재(300; 도 2, 3 참조)의 복원력에 의해 활성화 부재(200)는 다시 기단 방향으로 슬라이드하게 된다. 이때, 활성화 암(220)이 기단 방향으로 슬라이드 이동하면서, 활성화 되었던 가요성 요소(530)이 락킹 홀(222)에 삽입되면서 락킹이 이루어진다. 이후, 활성화 부재(200)에 원위 방향으로의 외력이 작용하더라도 가요성 요소(530)가 락킹 홀(222)의 락킹에 의해 활성화 부재(200)가 이동할 수 없다. 따라서 활성화 부재(200)가 최종적으로 락킹되었다고 볼 수 있으며, 최종 락킹된 상태에서는 약물 주입이 완료된 약물 용기(700; 도 2, 3 참조)의 주사 바늘(720; 도 2, 3 참조)이 더 이상 노출되지 않는다. After the injection of the drug solution is completed and the activation member (200) is removed from the user's body, the external force applied to the activation member (200) disappears, and the activation member (200) slides in the base direction again due to the restoring force of the first elastic member (300; see FIGS. 2 and 3). At this time, as the activation arm (220) slides in the base direction, the flexible element (530) that was activated is inserted into the locking hole (222), thereby locking. Thereafter, even if an external force is applied to the activation member (200) in the distal direction, the activation member (200) cannot move due to the locking of the flexible element (530) in the locking hole (222). Therefore, it can be seen that the activation member (200) is finally locked, and in the final locked state, the injection needle (720; see FIGS. 2 and 3) of the drug container (700; see FIGS. 2 and 3) in which the drug injection has been completed is no longer exposed.
이때, 가요성 요소(530)의 근위 단부가 락킹 홀(222) 내로 삽입되지 않고 미끄러져 활성화 암(220)의 내측으로 이동할 경우 락킹이 이루어지지 않는다. 이를 방지하기 위해, 가요성 요소(530)의 근위 단부(530a) 및 락킹 홀(222)의 근위 단부(222a)는 활성화 부재(200)가 원위 방향으로 이동 시에 가요성 요소(530)의 근위 단부(530a)가 반경 방향 외측으로 슬라이드되도록 경사진 형태를 가지는 것이 바람직하다. At this time, if the proximal end of the flexible element (530) is not inserted into the locking hole (222) but slides and moves inwardly of the activation arm (220), locking does not occur. To prevent this, it is preferable that the proximal end (530a) of the flexible element (530) and the proximal end (222a) of the locking hole (222) have an inclined shape so that the proximal end (530a) of the flexible element (530) slides radially outwardly when the activation member (200) moves in the distal direction.
도 8는 제2 실시예에 따른 자동 약물 주입 장치를 도시한 분해도, 도 9은 제2 실시예에 따른 자동 약물 주입 장치를 도시한 분해 단면도, 도 10는 제2 실시예에 따른 자동 약물 주입 장치의 하우징을 도시한 단면 사시도, 도 11는 제2 실시예에 따른 자동 약물 주입 장치의 활성화 부재를 도시한 사시도, 도 12은 제2 실시예에 따른 자동 약물 주입 장치의 잠금 부재를 도시한 사시도이다. FIG. 8 is an exploded view illustrating an automatic drug injection device according to a second embodiment, FIG. 9 is an exploded cross-sectional view illustrating an automatic drug injection device according to a second embodiment, FIG. 10 is a cross-sectional perspective view illustrating a housing of the automatic drug injection device according to the second embodiment, FIG. 11 is a perspective view illustrating an activating member of the automatic drug injection device according to the second embodiment, and FIG. 12 is a perspective view illustrating a locking member of the automatic drug injection device according to the second embodiment.
실시예에 따른 자동 약물 주입 장치는, 외관을 형성하는 튜브형 하우징(100b) 내에 약물을 저장하는 약물 저장부(710)와 피부를 침습하여 약물 저장부(710)에 저장된 약물을 주입할 수 있는 주사 바늘(720)을 구비하는 약물 용기가 약물 홀더(730)에 의해 고정되어 있다. 튜브형 하우징(100b) 내에서 약물 용기의 근위 측에는 활성화 부재(200b)와 활성화 부재(200b)를 기단 방향으로 가압하는 제1 탄성 부재가 설치되고, 약물 용기의 원위 측에는 약물을 가압하는 플런저(400)와 플런저(400)를 비활성화하고 있다가 활성화 부재(200)의 이동에 의해 활성화시키는 트리거 모듈(420, 500b, 700, 800)이 설치된다.An automatic drug injection device according to an embodiment comprises a drug storage unit (710) that stores a drug in a tubular housing (100b) that forms an exterior, and a drug container having an injection needle (720) that can inject the drug stored in the drug storage unit (710) by penetrating the skin, and is fixed by a drug holder (730). An activation member (200b) and a first elastic member that presses the activation member (200b) in a proximal direction are installed on the proximal side of the drug container in the tubular housing (100b), and a plunger (400) that pressurizes the drug and a trigger module (420, 500b, 700, 800) that deactivates the plunger (400) and then activates it by movement of the activation member (200) are installed on the distal side of the drug container.
상기한 바와 같이, 튜브형 하우징(100b)의 근위 단부 측에는 내에 축 방향으로 슬라이드 가능하게 설치되 활성화 부재(200b)와, 활성화 부재(200b)를 기단 방향으로 가압하는 제1 탄성 부재(300)를 포함한다. 활성화 부재(200)의 근위 단부(210)는 개방 단부로, 약물 주입 전 튜브형 하우징(100b)의 근위 단부(110b) 밖으로 노출되어 있다. 한편 튜브형 하우징(100b)의 원위 단부(120b)는 개방되어 있지 않고 폐쇄된 페쇄 단부이며 후술할 트리거 모듈이 트리거 해제 후 튜브형 하우징(100b)으로부터 이탈하는 것을 방지한다. As described above, the proximal end side of the tubular housing (100b) includes an activating member (200b) that is slidably installed in the axial direction, and a first elastic member (300) that presses the activating member (200b) in the distal direction. The proximal end (210) of the activating member (200) is an open end, which is exposed outside the proximal end (110b) of the tubular housing (100b) before drug injection. On the other hand, the distal end (120b) of the tubular housing (100b) is not open but is a closed end, which prevents a trigger module, which will be described later, from being separated from the tubular housing (100b) after the trigger is released.
플런저(400)는 트리거 하우징(500b) 내에 락킹되어 설치되며, 트리거가 해제되면 플런저(400)는 약물 저장부(710) 내에서 슬라이드 하며 약물을 가압한다. The plunger (400) is installed in a locked manner within the trigger housing (500b), and when the trigger is released, the plunger (400) slides within the drug storage unit (710) and pressurizes the drug.
제2 탄성 부재(600)가 트리거 하우징(500b)과 플런저(400) 사이에 설치되며, 제2 탄성 부재(600)는 플런저(400)를 기단 방향으로 가압할 수 있도록 압축된 상태로 설치된다. A second elastic member (600) is installed between the trigger housing (500b) and the plunger (400), and the second elastic member (600) is installed in a compressed state so as to pressurize the plunger (400) in the proximal direction.
활성화 부재(200b)가 원위 방향으로 슬라이드되어 자동 약물 주입 장치를 활성화시키기 전까지는 플런저(400)는 제2 탄성 부재(600)의 압력이 작용하는 상태에서도 기단 방향으로 이동하지 않도록 락킹이 이루어져 있다. The plunger (400) is locked so that it does not move in the proximal direction even when pressure from the second elastic member (600) is applied until the activation member (200b) slides distally to activate the automatic drug injection device.
튜브형 하우징(100b)에는 약물을 저장하는 약물 저장부(710)와 약물 저장된 약물을 주입하기 위한 주사 바늘(720)을 구비하는 약물 용기(700)가 설치된다. 약물 용기(700)는, 활성화 부재(200b)나 플런저(400)의 이동과 무관하게 약물 홀더(700)에 의해 튜브형 하우징(100b)에 위치가 고정된 상태를 유지한다. A drug container (700) having a drug storage section (710) for storing a drug and an injection needle (720) for injecting the drug stored in the tubular housing (100b) is installed in the tubular housing (100b). The drug container (700) is maintained in a fixed position in the tubular housing (100b) by the drug holder (700) regardless of movement of the activating member (200b) or the plunger (400).
이때 플런저(400)의 근위 단부는 약물 저장부(710) 내에 소정 깊이 삽입된 상태로 조립되어, 제2 탄성 부재(600)가 플런저(400)를 가압할 때 약물 저장부(710) 내에서 플런저(400)가 기단 방향으로 이동하면서 약물이 주사 바늘(720)을 통해 사용자의 체내로 주입된다. At this time, the proximal end of the plunger (400) is assembled in a state of being inserted into the drug storage unit (710) to a predetermined depth, so that when the second elastic member (600) presses the plunger (400), the plunger (400) moves in the proximal direction within the drug storage unit (710), and the drug is injected into the user's body through the injection needle (720).
활성화 부재(200b)는 근위 단부(210b)는 캡형으로 근위 단부(210b)의 말단에는 사용자의 피부에 접촉하는 접촉면을 구비한다. 접촉면의 중앙에는 홀이 구비되어 활성화 부재(200b)의 후퇴 시에 주사 바늘(720)이 홀을 통해 노출된다. The activation member (200b) has a cap-shaped proximal end (210b) and a contact surface at the end of the proximal end (210b) that comes into contact with the user's skin. A hole is provided in the center of the contact surface, and when the activation member (200b) is retracted, the injection needle (720) is exposed through the hole.
활성화 부재(200b)는 근위 단부(210b)로부터 원위 방향으로 연장되는 활성화 암(220b)를 더 포함한다. 활성화 암(220b)에는 후술할 잠금 부재(900b)가 수용되는 락킹 홀(222b)이 형성된다. The activation member (200b) further includes an activation arm (220b) extending distally from the proximal end (210b). A locking hole (222b) is formed in the activation arm (220b) to accommodate a locking member (900b) to be described later.
플런저(400)를 락킹 및 락킹 해제하는 트리거 모듈은 플런저(400)의 트리거 (420), 트리거 하우징(500b), 제2 탄성 부재(600) 및 안전캡 모듈(800)로 이루어지며, 트리거 모듈은 안전핀 모듈(800)의 안전핀(830)이 해제되어야 작동한다. The trigger module for locking and unlocking the plunger (400) is composed of a trigger (420) of the plunger (400), a trigger housing (500b), a second elastic member (600), and a safety cap module (800), and the trigger module operates only when the safety pin (830) of the safety pin module (800) is released.
플런저(400)는, 후술할 약물 용기(710) 내로 슬라이드 하며 약액을 주입하는 플런저 로드(410)와, 플런저 로드(410)의 원위 단부로부터 원위 방향으로 연장되는 복수 개의 트리거 암(420)을 구비한다. 복수 개의 트리거 암(420)은 플런저 로드(410)의 원위 단부의 외주를 따라 서로 간격을 두고 형성되며, 트리거 암(420)들의 중앙에는 공동이 형성된다. 공동 내로는 후술할 안전핀 모듈(800)의 안전핀(830)이 삽입된다. 트리거 암(420)의 원위 단부에는 화살촉 모양의 락킹 돌기(422)가 형성된다. The plunger (400) has a plunger rod (410) that slides into a drug container (710) to be described later and injects a drug solution, and a plurality of trigger arms (420) that extend distally from a distal end of the plunger rod (410). The plurality of trigger arms (420) are formed at intervals from each other along the outer periphery of the distal end of the plunger rod (410), and a cavity is formed in the center of the trigger arms (420). A safety pin (830) of a safety pin module (800) to be described later is inserted into the cavity. An arrowhead-shaped locking protrusion (422) is formed at the distal end of the trigger arm (420).
트리거 하우징(500b)은 튜브형의 몸체(510b)를 구비하며, 원위 단부 측에 몸체(510b)의 내주면을 따라 링 형상의 걸림턱(520b)이 형성된다. The trigger housing (500b) has a tubular body (510b), and a ring-shaped catch (520b) is formed along the inner surface of the body (510b) on the distal end side.
안전핀 모듈(800)은 튜브형 하우징(100)의 원위 단부에 결합된다. 안전핀 모듈(800)은 튜브형 몸체(810), 튜브형 몸체(810)의 원위 단부에 형성되는 헤드부(820) 및 헤드부(820)로부터 기단 방향으로 돌출되어 트리거 암(420)들 내측 공동에 삽입되는 안전핀(830)을 구비한다. A safety pin module (800) is coupled to the distal end of the tubular housing (100). The safety pin module (800) has a tubular body (810), a head portion (820) formed at the distal end of the tubular body (810), and a safety pin (830) protruding from the head portion (820) in a proximal direction and inserted into an inner cavity of the trigger arms (420).
트리거 하우징(500b)은 튜브형 하우징(100b)에 고정된 상태로, 트리거 하우징(500b)의 원위 단부는 안전핀 모듈(800) 내, 즉, 튜브형 몸체(810) 내에 위치한다. The trigger housing (500b) is fixed to the tubular housing (100b), and the distal end of the trigger housing (500b) is located within the safety pin module (800), i.e., within the tubular body (810).
트리거 암(420)의 락킹 돌기(422)는 안전핀(830)이 삽입되면 반경 방향 외측으로 벌어지게 되고, 트리거 하우징(500b)의 걸림턱(520b)과 락킹이 이루어진다. 안전핀 모듈(800)의 안전핀(830)이 트리거 암(420)들 사이의 공동으로부터 제거되지 않는한 트리거 하우징(500b)과 트리거 암(420)의 락킹이 해제되지 않는다. 이때, 트리거 암(420)은 반경 방향으로 탄성적으로 이동 가능한 것이 바람직하며, 안전핀(830)이 트리거 암(420)들의 중간으로 삽입되지 않은 경우, 락킹 돌기(422)의 돌출 반경이 트리거 하우징(500b)의 걸림턱(520b) 내주면 지름보다 작은 것이 바람직하다. 그에 따라 안전핀(830)이 제거되면, 트리거 암(420)이 원 위치로 이동하면서 걸림턱(520b)과 락킹 돌기(422)의 락킹이 쉽게 해제된다. The locking projection (422) of the trigger arm (420) is spread outward in the radial direction when the safety pin (830) is inserted, and is locked with the engaging projection (520b) of the trigger housing (500b). The locking of the trigger housing (500b) and the trigger arm (420) is not released unless the safety pin (830) of the safety pin module (800) is removed from the cavity between the trigger arms (420). At this time, it is preferable that the trigger arm (420) is elastically movable in the radial direction, and when the safety pin (830) is not inserted into the middle of the trigger arms (420), it is preferable that the protruding radius of the locking projection (422) is smaller than the inner diameter of the engaging projection (520b) of the trigger housing (500b). Accordingly, when the safety pin (830) is removed, the trigger arm (420) moves to the original position, and the locking of the catch (520b) and the locking projection (422) is easily released.
또한 튜브형 하우징(100b)에는 후술할 잠금 부재(900b)에 의해 수축되어 있다가 잠금 부재(900b)가 제2 위치로 이동하면 벌어지면서 활성화 부재(200b)를 락킹하는 가요성 요소(130b)가 형성된다. 또한 활성화 부재(200b)의 원위 방향 이동에 의해 잠금 부재(900b)가 제2 위치로 이동했을 때 잠금 부재(900b)의 위치를 고정하기 위한 잠금 요소를 구비한다. 제2 실시예에서 잠금 요소는 잠금 부재(900b)에 형성된 홀(910b)과, 튜브형 하우징(100b)에 형성되며 홀(910b) 내에 삽입되는 잠금 돌기(142b)이다. In addition, the tubular housing (100b) is formed with a flexible element (130b) that is contracted by a locking member (900b) to be described later and then opens when the locking member (900b) moves to a second position to lock the activating member (200b). In addition, a locking element is provided for fixing the position of the locking member (900b) when the locking member (900b) moves to the second position by the distal movement of the activating member (200b). In the second embodiment, the locking element is a hole (910b) formed in the locking member (900b) and a locking projection (142b) formed in the tubular housing (100b) and inserted into the hole (910b).
이때, 튜브형 하우징(100b)은 잠금 돌기(142b) 외에 스톱 돌기(144b)를 더 포함할 수 있으며, 스톱 돌기(144b)는 잠금 부재(900b)의 원위 단부(920b)와 맞닿아 잠금 부재(900b)가 원위 방향으로 더 이동하는 것을 방지한다. At this time, the tubular housing (100b) may further include a stop projection (144b) in addition to the locking projection (142b), and the stop projection (144b) comes into contact with the distal end (920b) of the locking member (900b) to prevent the locking member (900b) from moving further in the distal direction.
잠금 부재(900b)는 상기한 바와 같이 활성화 부재(200b)의 락킹 홀(222b) 내에 설치되는데, 활성화 부재(200b)가 원위 방향으로 슬라이드될 때 활성화 부재(200b)와 함께 이동하며, 제1 위치에서 제2 위치로 이동한다. 잠금 부재(900b)가 제1 위치에 있을 때, 가요성 요소(130b)는 잠금 부재(900b)에 의해 반경 방향 내측으로 수축된 상태로 있다가, 잠금 부재(900b)가 제2 위치로 이동하면 근위 단부가 반경 방향 외측으로 벌어진다. 잠금 부재(900b)는 제2 위치에서 잠금 요소에 의해 위치가 고정된 상태로 활성화 부재(200b)가 초기 위치로 복귀하기 위해서는, 활성화 부재(200b)에 형성된 락킹 홀(222b)의 길이가 잠금 부재(900b)의 길이와 잠금 부재(900b)가 제1 위치에서 제2 위치로 이동한 거리의 합보다 크거나 같은 것이 바람직하다. The locking member (900b) is installed in the locking hole (222b) of the activating member (200b) as described above, and moves together with the activating member (200b) when the activating member (200b) slides distally, and moves from the first position to the second position. When the locking member (900b) is in the first position, the flexible element (130b) is contracted radially inwardly by the locking member (900b), and when the locking member (900b) moves to the second position, the proximal end thereof spreads radially outwardly. In order for the activating member (200b) to return to the initial position while the locking member (900b) is fixed in position by the locking element in the second position, it is preferable that the length of the locking hole (222b) formed in the activating member (200b) is greater than or equal to the sum of the length of the locking member (900b) and the distance that the locking member (900b) moves from the first position to the second position.
한편 잠금 부재(900b)가 제2 위치에서 고정되어 제1 위치로 다시 이동하지 않기 때문에, 가요성 요소(130b)의 근위 단부는 반경 방향 외측으로 벌어진 상태를 계속 유지한다. Meanwhile, since the locking member (900b) is fixed in the second position and does not move back to the first position, the proximal end of the flexible element (130b) continues to be spread out radially outward.
활성화 부재(200b)가 이후 제1 탄성 부재(300)의 복원력에 의해 기단 방향으로 이동하여 초기 위치로 되돌아갈 때, 가요성 요소(130b)의 근위 단부는 활성화 부재(200b)의 락킹 홀(222b) 내로 삽입되고, 이후 활성화 부재(200b)에 원위 방향 외력이 작용하여도 락킹 홀(222b)과 가요성 요소(130b)의 간섭에 의해 활성화 부재(200b)는 이동하지 않도록 최종 락킹된다. 따라서 약물 주입 완료 후에 더 이상 주사 바늘(720)이 노출되지 않는다. When the activating member (200b) is moved in the proximal direction by the restoring force of the first elastic member (300) and returns to the initial position, the proximal end of the flexible element (130b) is inserted into the locking hole (222b) of the activating member (200b), and even if a distal external force is applied to the activating member (200b) thereafter, the activating member (200b) is finally locked so as not to move due to the interference of the locking hole (222b) and the flexible element (130b). Therefore, the injection needle (720) is no longer exposed after the drug injection is completed.
도 13은 제2 실시예에 따른 자동 약물 주입 장치의 초기 상태를 도시한 단면도, 도 14은 제2 실시예에 따른 자동 약물 주입 장치의 트리거 해제 시작 시 모습을 도시한 단면도, Fig. 13 is a cross-sectional view showing the initial state of the automatic drug injection device according to the second embodiment, Fig. 14 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment at the start of trigger release.
앞서 설명한 바와 같이 활성화 부재(200b)가 원위 방향으로 이동하면, 활성화 암(220b)이 안전핀 모듈(830)의 헤드부(810)와 맞닿은 뒤, 원위 방향으로 밀게 된다. 이때, 잠금 부재(900b)도 활성화 부재(200b)와 함께 원위 방향으로 이동하기 시작하고, 하우징(100b)의 가요성 요소(130b)의 근위 단부도 조금씩 잠금 부재(900b)를 빠져나와 반경 방향 외측으로 벌어지기 시작한다.As described above, when the activating member (200b) moves distally, the activating arm (220b) comes into contact with the head portion (810) of the safety pin module (830) and is pushed distally. At this time, the locking member (900b) also begins to move distally together with the activating member (200b), and the proximal end of the flexible element (130b) of the housing (100b) also gradually comes out of the locking member (900b) and begins to spread outward in the radial direction.
잠금 부재(900b)의 근위 단부는 제1 위치에서 제2 위치까지 이동하는 동안 락킹 홀(222b)의 근위 단부와 접촉상태를 유지한다. The proximal end of the locking member (900b) maintains contact with the proximal end of the locking hole (222b) while moving from the first position to the second position.
도 15은 제2 실시예에 따른 자동 약물 주입 장치의 트리거 해제 후 모습을 도시한 단면도이다. Fig. 15 is a cross-sectional view showing the appearance of an automatic drug injection device according to the second embodiment after the trigger is released.
활성화 부재(200b)가 원위 방향 최종 위치에 도달하면 안전핀(830)이 트리거 암(420)으로부터 해제되고 트리거 모듈이 작동하게 된다. 안전핀(830)이 제거되고, 트리거 암(420)의 락킹 돌기(422)가 반경 방향 내측으로 이동하면서 트리거 하우징(500b)의 걸림턱(510b)과의 락킹이 쉽게 해제된다. When the activation member (200b) reaches the distal final position, the safety pin (830) is released from the trigger arm (420) and the trigger module is activated. The safety pin (830) is removed and the locking projection (422) of the trigger arm (420) moves radially inward, easily releasing the locking with the engaging projection (510b) of the trigger housing (500b).
또한 활성화 부재(200b)가 원위 방향 최종 위치에 도달하면, 활성화 부재(200b)의 락킹 홀(222b) 내에 수용된 잠금 부재(900b)도 제2 위치에 도달하고, 튜브형 하우징(100b)의 잠금 돌기(142b)와 잠금 부재(900b)의 잠금홀(910b)이 서로 락킹되며, 잠금 부재(900b)의 위치가 제2 위치에 고정된다.In addition, when the activating member (200b) reaches the distal final position, the locking member (900b) accommodated in the locking hole (222b) of the activating member (200b) also reaches the second position, and the locking projection (142b) of the tubular housing (100b) and the locking hole (910b) of the locking member (900b) are locked with each other, and the position of the locking member (900b) is fixed at the second position.
즉, 활성화 부재(200b)가 원위 방향 최종 위치에 도달하면, 하우징(100b)의 잠금 돌기(142b)가 잠금 부재(900b)의 락킹 홀(910b)에 락킹되며, 플런저(400)의 트리거 암(420)과 트리거 하우징(500b)의 락킹이 해제된다. That is, when the activation member (200b) reaches the distal final position, the locking projection (142b) of the housing (100b) is locked into the locking hole (910b) of the locking member (900b), and the locking of the trigger arm (420) of the plunger (400) and the trigger housing (500b) is released.
하우징(100b)의 가요성 요소(130b)의 근위 단부도 잠금 부재(900b)를 완전히 빠져나와 반경 방향 외측으로 벌어진다.The proximal end of the flexible element (130b) of the housing (100b) also completely escapes the locking member (900b) and spreads radially outward.
도 16은 제2 실시예에 따른 자동 약물 주입 장치의 약물 주입 완료 후 모습을 도시한 단면도이다. Figure 16 is a cross-sectional view showing the appearance of the automatic drug injection device according to the second embodiment after drug injection is completed.
압축되어 있던 제2 탄성 부재(600)의 복원력에 의해 플런저(400)는 기단 방향으로 이동하고, 그에 따라 플런저(400)가 약물 저장부(710) 내에서 기단 방향으로 이동하며 약액을 가압하여 주사 바늘을 통해 사용자의 신체 내로 주입된다. The plunger (400) moves toward the base by the restoring force of the compressed second elastic member (600), and accordingly, the plunger (400) moves toward the base within the drug storage unit (710) and pressurizes the drug solution, which is injected into the user's body through the injection needle.
도 17은 제2 실시예에 따른 자동 약물 주입 장치의 활성화 부재가 초기 위치로 복귀 후 최종 락킹된 모습을 도시한 단면도이다. FIG. 17 is a cross-sectional view showing the final locked state after the activating member of the automatic drug injection device according to the second embodiment returns to the initial position.
활성화 부재(200b)는 제1 탄성 부재(300)의 복원력에 의해 기단 방향으로 이동하여 초기 위치로 복귀하지만, 락킹 홀(222b) 내에 설치된 잠금 부재(900b)는 하우징(100b)의 잠금 돌기(142b)와 잠금된 상태로, 제2 위치를 유지한다. 이때 잠금 부재(900b)의 원위 단부는 락킹 홀(222b)의 원위 단부 사이의 거리가 최소가 되며, 잠금 부재(900b)의 근위 단부와 락킹 홀(222b)의 근위 단부 사이의 거리는 최대가 된다. The activation member (200b) moves toward the base by the restoring force of the first elastic member (300) and returns to the initial position, but the locking member (900b) installed in the locking hole (222b) is locked with the locking projection (142b) of the housing (100b) and maintains the second position. At this time, the distance between the distal end of the locking member (900b) and the distal end of the locking hole (222b) becomes minimum, and the distance between the proximal end of the locking member (900b) and the proximal end of the locking hole (222b) becomes maximum.
따라서 락킹 홀(222b)의 근위 단부가 기단 방향으로 더 이동함으로써, 하우징(100b)의 가요성 요소(130b)의 근위 단부는 반경 방향 외측으로 더 벌어져 활성화 부재(200b)의 락킹 홀(222b) 내에 삽입된다. Accordingly, as the proximal end of the locking hole (222b) moves further in the base direction, the proximal end of the flexible element (130b) of the housing (100b) is further spread outward in the radial direction and inserted into the locking hole (222b) of the activating member (200b).
이후, 활성화 부재(200b)가 원위 방향으로 힘을 받더라도, 가요성 요소(130b)와 락킹 홀(222b)이 서로 간섭하여 활성화 부재(200b)의 이동이 제한되며, 주사 바늘(720)이 외부로 노출되는 것을 방지할 수 있다. Thereafter, even if the activation member (200b) receives force in the distal direction, the flexible element (130b) and the locking hole (222b) interfere with each other, thereby limiting the movement of the activation member (200b), and preventing the injection needle (720) from being exposed to the outside.
도 18는 제3 실시예에 따른 자동 약물 주입 장치의 잠금 부재와 가요성 요소를 도시한 단면도, 도 19은 제3 실시예에 따른 자동 약물 주입 장치의 약물 홀더를 도시한 사시도이다. FIG. 18 is a cross-sectional view illustrating a locking member and a flexible element of an automatic drug injection device according to a third embodiment, and FIG. 19 is a perspective view illustrating a drug holder of an automatic drug injection device according to the third embodiment.
가요성 요소(732c)가 약물 용기를 하우징(100c)에 고정하는 약물 홀더(730c)에 형성되는 것을 제외하고는 다른 구성 요소는 제2 실시예와 동일하다.Except that the flexible element (732c) is formed in the drug holder (730c) that secures the drug container to the housing (100c), the other components are the same as in the second embodiment.
약물 홀더(730c)에 형성되는 가요성 요소(732c) 또한 잠금 부재(900b)가 제1 위치에서 제2 위치로 이동하면, 근위 단부가 반경 방향 외측으로 벌어지도록 ㄷ자로 절개되며, 근위 단부가 자유단이며, 원위 단부가 고정단인 형태이다. The flexible element (732c) formed in the drug holder (730c) is also cut in a T-shape so that the proximal end spreads outward in a radial direction when the locking member (900b) moves from the first position to the second position, and the proximal end is a free end and the distal end is a fixed end.
활성화 부재(200b)가 초기 위치로 이동하면 활성화 부재(200b)의 락킹 홀(222b) 내에 약물 홀더(730c)의 가요성 요소(732c)의 근위 단부가 락킹되어 활성화 부재를 최종 락킹한다. When the activating member (200b) moves to the initial position, the proximal end of the flexible element (732c) of the drug holder (730c) is locked within the locking hole (222b) of the activating member (200b), thereby finally locking the activating member.
도 20는 제4 실시예에 따른 자동 약물 주입 장치의 잠금 부재 안착 요소를 도시한 도면이다. FIG. 20 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fourth embodiment.
앞서 설명한 바와 같이, 활성화 부재(200b)가 원위 방향으로 이동할 때 락킹 홀(222b)에 형성된 잠금 부재(900d)가 활성화 부재(200b)와 함께 이동했다가 잠금 부재(900d)는 제2 위치에 고정되고, 활성화 부재(200b)만 초기 위치로 복귀하기 위해서는 락킹 홀(222b)의 길이가 잠금 부재(900d)의 길이보다 길어야 한다. 바람직하게는, 락킹 홀(222b)의 길이는, 잠금 부재(900d)의 길이와 잠금 부재(900d)가 제1 위치에서 제2 위치로 이동한 거리의 합보다 크거나 같아야 한다. As described above, when the activating member (200b) moves in the distal direction, the locking member (900d) formed in the locking hole (222b) moves together with the activating member (200b), and then the locking member (900d) is fixed to the second position, so that only the activating member (200b) returns to the initial position, the length of the locking hole (222b) must be longer than the length of the locking member (900d). Preferably, the length of the locking hole (222b) must be greater than or equal to the sum of the length of the locking member (900d) and the distance that the locking member (900d) moves from the first position to the second position.
따라서 활성화 부재(200b)가 초기 위치에 있을 때 잠금 부재(900d)가 락킹 홀(222b) 내에서 제1 위치에 위치가 고정되어 있지 않고 락킹 홀(222b) 내에서 이리 저리 움직일 수 있다. 이를 방지하기 위해 제3 실시예는, 잠금 부재(900d)를 제1 위치에 안착시키기 위한 안착 요소를 추가로 구비한다. Therefore, when the activation member (200b) is in the initial position, the locking member (900d) is not fixed in the first position within the locking hole (222b) and may move around within the locking hole (222b). To prevent this, the third embodiment additionally provides a fixing element for fixing the locking member (900d) in the first position.
제3 실시예에 따르면, 잠금 부재(900d)는 가요성 요소(130)와 접하는 위치에 오목부(930d)를 구비하고, 가요성 요소(130b)가 오목부(930d) 내에 삽입되어 잠금 부재(900b)의 이동을 제한한다. 그러나 오목부(930d)는 가요성 요소(130b)의 근위 단부와 완전히 락킹되어 잠금 부재(900d)의 이동을 불가능하게 하는 것은 아니며, 활성화 부재(200b)에 외력이 작용하는 경우 가요성 요소(130b)가 오목부(930d)를 벗어나 이동이 가능하도록 오목부(930d)의 깊이가 얕게 형성된다. According to the third embodiment, the locking member (900d) has a recessed portion (930d) at a position where it comes into contact with the flexible element (130), and the flexible element (130b) is inserted into the recessed portion (930d) to restrict movement of the locking member (900b). However, the recessed portion (930d) is not completely locked with the proximal end of the flexible element (130b) to prevent movement of the locking member (900d), and the depth of the recessed portion (930d) is formed shallow so that the flexible element (130b) can move out of the recessed portion (930d) when an external force is applied to the activating member (200b).
도 21는 제5 실시예에 따른 자동 약물 주입 장치의 잠금 부재 안착 요소를 도시한 도면이다. FIG. 21 is a drawing illustrating a locking member fixing element of an automatic drug injection device according to the fifth embodiment.
제5 실시예도 잠금 부재(900e)를 제1 위치에 안착시키기 위한 안착 요소를 구비하나, 제3 실시예와 안착 요소의 형성 위치 및 형상이 다소 상이하다. The fifth embodiment also has a fixing element for fixing the locking member (900e) in the first position, but the formation position and shape of the fixing element are somewhat different from those of the third embodiment.
안착 요소는 잠금 부재(900e)가 하우징(100e)과 접촉하는 면에 형성되는 돌기(930e)이면, 하우징(100e)는 돌기(930e)를 수용하는 오목부(150e)를 구비한다. 이때, 하우징(100e)은 오목부(150e)를 구비하지 않더라도, 오목부(150e)의 돌출 높이가 잠금 부재(900e)와 하우징(100e)의 내주면 사이의 간격보다 높을 경우 돌기(930e)와 하우징(100e)의 간섭에 의해 잠금 부재(900e)가 제1 위치에서 이탈하는 것을 방지할 수 있다. If the fixing element is a projection (930e) formed on the surface where the locking member (900e) comes into contact with the housing (100e), the housing (100e) has a concave portion (150e) that accommodates the projection (930e). At this time, even if the housing (100e) does not have the concave portion (150e), if the protruding height of the concave portion (150e) is higher than the gap between the locking member (900e) and the inner surface of the housing (100e), the locking member (900e) can be prevented from being disengaged from the first position due to interference between the projection (930e) and the housing (100e).

Claims (12)

  1. 외관을 형성하는 튜브형 하우징; A tubular housing forming the exterior;
    약물을 저장하는 약물 저장부와 피부를 침습하여 약물 저장부에 저장된 약물을 주입할 수 있는 주사 바늘을 구비하며 튜브형 하우징에 고정된 약물 용기;A drug container having a drug storage compartment for storing a drug and an injection needle capable of injecting the drug stored in the drug storage compartment by penetrating the skin, and fixed to a tubular housing;
    튜브형 하우징을 따라 슬라이드 가능하게 설치되며, 슬라이드 방향으로 형성된 수용홀을 구비하는 활성화 부재; An activating member that is installed slidably along a tubular housing and has a receiving hole formed in the sliding direction;
    활성화 부재를 기단 방향으로 가압하는 제1 탄성 부재;A first elastic member for pressurizing the activation member in the direction of the base;
    활성화 부재의 이동에 의해 활성화되어 약물 용기 내의 약물을 가압하는 플런저; A plunger that is activated by movement of the activating member to pressurize the drug within the drug container;
    튜브형 하우징의 원위 단부에 설치되며, 원위 단부 측에 원주 방향을 따라 형성된 걸림턱을 구비하는 트리거 하우징;A trigger housing installed at the distal end of a tubular housing and having a catch formed along the circumference on the distal end side;
    튜브형 락킹 부재 내에 슬라이드 가능하게 설치되며, 플런저 로드 및 플런저 로드로부터 원위 방향으로 연장되며 트리거 부재의 걸림턱에 걸림되는 락킹 돌기가 형성된 복수 개의 트리거 암을 구비하는 플런저;A plunger slidably installed within a tubular locking member, the plunger having a plunger rod and a plurality of trigger arms extending distally from the plunger rod and having locking projections formed therein for engaging with engaging jaws of the trigger member;
    튜브형 하우징의 내부에 형성되며, 튜브형 몸체, 튜브형 몸체의 원위 단부에 형성되는 헤드부 및 헤드부로부터 기단 방향으로 돌출되어 트리거 암들 내측 공동에 삽입되는 안전핀을 구비하는 안전핀 모듈; 및A safety pin module formed inside a tubular housing, comprising a tubular body, a head formed at a distal end of the tubular body, and a safety pin protruding from the head in a proximal direction and inserted into an inner cavity of the trigger arms; and
    튜브형 트리거 하우징 내에 설치되며, 플런저를 기단 방향으로 가압하는 제2 탄성 부재;를 포함하고,A second elastic member is installed within the tubular trigger housing and presses the plunger in the proximal direction;
    활성화 부재는, 주사 바늘의 노출을 방지하는 캡 형의 근위 단부와 근위 단부로부터 원위 방향으로 연장되는 활성화 암 및 활성화 암에 형성되는 락킹 홀을 구비하고, The activation member has a cap-shaped proximal end that prevents exposure of the injection needle, an activation arm extending distally from the proximal end, and a locking hole formed in the activation arm.
    활성화 부재가 원위 방향으로 슬라이드 하면서 활성화 암이 안전핀 모듈을 원위 방향으로 이동시켜 안전핀을 플런저의 트리거 암으로부터 인출하여 플런저와 안전핀 모듈의 락킹을 해제하고, As the activating member slides distally, the activating arm moves the safety pin module distally to withdraw the safety pin from the trigger arm of the plunger, thereby unlocking the plunger and safety pin module.
    튜브형 하우징 또는 튜브형 하우징에 고정되는 부품 중 어느 하나에 형성되며, 근위 단부가 자유단이고 원위 단부가 고정단이며 근위 단부로 갈수록 더 반경 방향 외측으로 뻗어있으며, 반경 방향으로 탄성 이동이 가능한 가요성 요소를 구비하며, Formed in either a tubular housing or a component fixed to the tubular housing, the proximal end being a free end, the distal end being a fixed end, and extending more radially outward toward the proximal end, and having a flexible element capable of elastically moving in the radial direction;
    활성화 부재가 초기 위치로 이동하면 활성화 부재의 수용홀과 가요성 요소의 근위 단부가 락킹되어 활성화 부재를 최종 락킹하는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device characterized in that when the activation member moves to an initial position, the receiving hole of the activation member and the proximal end of the flexible element are locked to finally lock the activation member.
  2. 제1항에 있어서, In the first paragraph,
    가요성 요소는 트리거 하우징에 형성되고, The flexible element is formed in the trigger housing,
    트리거 하우징의 원위 단부는 안전핀 모듈 내에 삽입되어 있으며, The distal end of the trigger housing is inserted into the safety pin module,
    활성화 부재에 의해 안전핀 모듈이 원위 방향으로 이동하기 전에 가요성 요소는 안전핀 모듈 내에 수용되어 활성화 암의 락킹 홀과 락킹이 이루어지지 않는 비활성 상태인 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that before the safety pin module moves distally due to the absence of activation, the flexible element is accommodated within the safety pin module and is in an inactive state in which it is not locked with the locking hole of the activation arm.
  3. 제1항에 있어서, In the first paragraph,
    가요성 요소는 트리거 하우징에 형성되고, The flexible element is formed in the trigger housing,
    가요성 요소의 근위 단부 및 락킹 홀의 근위 단부는 활성화 부재가 원위 방향으로 이동 시에 가요성 요소의 근위 단부가 반경 방향 외측으로 슬라이드되도록 경사진 형태를 가지는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the proximal end of the flexible element and the proximal end of the locking hole have an inclined shape so that the proximal end of the flexible element slides radially outward when the activating member moves in the distal direction.
  4. 제1항에 있어서,In the first paragraph,
    활성화 암의 원위 단부로부터 안전핀 모듈의 헤드부의 근위 단부까지의 거리가, 락킹 홀의 근위 단부로부터 안전핀 모듈의 튜브형 몸체의 근위 단부까지의 거리보다 더 긴 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the distance from the distal end of the activation arm to the proximal end of the head of the safety pin module is longer than the distance from the proximal end of the locking hole to the proximal end of the tubular body of the safety pin module.
  5. 제1항에 있어서,In the first paragraph,
    활성화 부재의 수용홀 내에 설치되며, 활성화 부재의 이동에 의해 제1 위치에서 제2 위치로 이동한 뒤 튜브형 하우징에 고정되는 잠금 부재;를 더 포함하고, It further includes a locking member which is installed in the receiving hole of the activation member and is fixed to the tubular housing after moving from the first position to the second position by the movement of the activation member;
    가요성 요소는 잠금 부재가 제1 위치에서 제2 위치로 이동하면 근위 단부가 반경 방향 외측으로 벌어지는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, wherein the flexible element is characterized in that the proximal end opens radially outwardly when the locking member moves from the first position to the second position.
  6. 제5항에 있어서, In paragraph 5,
    잠금 부재와 튜브형 하우징은 잠금 요소를 구비하며, 잠금 부재가 제2 위치로 이동하면 잠금 부재와 튜브형 하우징의 잠금 요소가 서로 맞물리는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the locking member and the tubular housing have locking elements, and when the locking member moves to the second position, the locking elements of the locking member and the tubular housing engage with each other.
  7. 제5항에 있어서, In paragraph 5,
    가요성 요소는 튜브형 하우징에 형성되는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device characterized in that the flexible element is formed in a tubular housing.
  8. 제5항에 있어서,In paragraph 5,
    약물 용기를 튜브형 하우징에 고정하는 약물 홀더;를 더 포함하며, Further comprising a drug holder for fixing the drug container to the tubular housing;
    가요성 요소는 약물 홀더에 형성되는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the flexible element is formed in a drug holder.
  9. 제5항에 있어서, In paragraph 5,
    활성화 부재에 형성된 락킹 홀의 길이는, 잠금 부재의 길이와 잠금 부재가 제1 위치에서 제2 위치로 이동한 거리의 합보다 크거나 같은 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the length of the locking hole formed in the activation member is greater than or equal to the sum of the length of the locking member and the distance the locking member moves from the first position to the second position.
  10. 제9항에 있어서, In Article 9,
    활성화 부재가 플런저를 활성화하기 전, 잠금 부재의 위치를 제1 위치에 고정하기 위한 안착 요소;를 더 포함하는 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, further characterized by including a seating element for fixing the position of the locking element in the first position before the activating member activates the plunger.
  11. 제10항에 있어서,In Article 10,
    안착 요소는 가요성 요소의 근위 단부 및 잠금 부재에 형성되며 가요성 요소의 근위 단부가 안착되는 오목부인 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, wherein the anchoring element is formed in the proximal end of the flexible element and the locking member, and is characterized by a concave portion in which the proximal end of the flexible element is anchored.
  12. 제10항에 있어서,In Article 10,
    안착 요소는 잠금 부재에 형성되는 돌기 또는 오목부와, 하우징에 형성되며 잠금 부재의 돌기가 수용되는 오목부 또는 잠금 부재의 오목부에 수용되는 돌기인 것을 특징으로 하는 자동 약물 주입 장치.An automatic drug injection device, characterized in that the securing element is a projection or recess formed on a locking member, and a recess formed on a housing and configured to receive the projection of the locking member or a projection received in the recess of the locking member.
PCT/KR2024/095206 2023-02-15 2024-02-15 Automated medication injection device WO2024172557A1 (en)

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KR10-2023-0020359 2023-02-15
KR1020230020359A KR102682089B1 (en) 2023-02-15 2023-02-15 Auto-injector
KR10-2023-0044635 2023-04-05
KR1020230044635A KR102694749B1 (en) 2023-04-05 2023-04-05 Auto-injector

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JP2019208575A (en) * 2018-05-31 2019-12-12 Phcホールディングス株式会社 Adapter for syringe, medicine injection device and medicine injection system
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US20220215779A1 (en) * 2019-06-26 2022-07-07 Shl Medical Ag Drive mechanism for a medicament delivery training device

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KR20130012966A (en) * 2010-03-31 2013-02-05 에스에이치엘 그룹 에이비 Medicament delivery device
KR20200018603A (en) * 2017-07-12 2020-02-19 에스에이치엘 메디컬 아게 Dosage assembly for drug delivery device and drug delivery device comprising same
JP2019208575A (en) * 2018-05-31 2019-12-12 Phcホールディングス株式会社 Adapter for syringe, medicine injection device and medicine injection system
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