US20160361503A1 - Device and method for delivering a medicament - Google Patents

Device and method for delivering a medicament Download PDF

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Publication number
US20160361503A1
US20160361503A1 US15/116,418 US201515116418A US2016361503A1 US 20160361503 A1 US20160361503 A1 US 20160361503A1 US 201515116418 A US201515116418 A US 201515116418A US 2016361503 A1 US2016361503 A1 US 2016361503A1
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United States
Prior art keywords
housing
latch
rotator
medicament
spring
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US15/116,418
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English (en)
Inventor
Antonio Bendek
Lucio Giambattista
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SHL Medical AG
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Carebay Europe Ltd
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Priority to US15/116,418 priority Critical patent/US20160361503A1/en
Publication of US20160361503A1 publication Critical patent/US20160361503A1/en
Assigned to SHL MEDICAL AG reassignment SHL MEDICAL AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CAREBAY EUROPE LIMITED
Assigned to CAREBAY EUROPE LTD reassignment CAREBAY EUROPE LTD ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: BENDEK, ANTONIO, GIAMBATTISTA, LUCIO
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31501—Means for blocking or restricting the movement of the rod or piston
    • A—HUMAN NECESSITIES
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31578—Constructional features or modes of drive mechanisms for piston rods based on axial translation, i.e. components directly operatively associated and axially moved with plunger rod
    • A—HUMAN NECESSITIES
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    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
    • A61M5/31591—Single dose, i.e. individually set dose administered only once from the same medicament reservoir, e.g. including single stroke limiting means
    • A—HUMAN NECESSITIES
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
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    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
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    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/202—Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A—HUMAN NECESSITIES
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    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
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    • A61M2205/00—General characteristics of the apparatus
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    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback

Definitions

  • the present invention relates to a device and method for delivering medicament to a patient from a container mounted within the device.
  • the device is adapted to automatically perform the delivery by requiring only that the user push the device against an injection site.
  • the driving force needed for delivery is supplied by a coiled tension spring that is triggered by a rotating latch.
  • a lockout mechanism is provided to prevent retraction of a protective shield after delivery.
  • Devices for the delivery of medicament in an automatic way e.g. auto-injectors
  • devices for the delivery of a medicament include covers and other components that protect users before and after use of the injector.
  • different devices for the delivery of medicament vary in their total feature sets, they all have a mechanism that delivers the contents of a preloaded, prefilled container automatically, i.e., without requiring a person to manually force the contents within a container through a delivery member, e.g., a needle or a nozzle, into the patient.
  • Auto-injectors are described in U.S. Pat. No. 5,478,316 to Bitdinger et al.; No. 7,112,187 to Karlsson; and No. 7,125,395 to Hommann et al.; U.S. Patent Application Publication No. 2007/0021720 to Guillermo; and International Publication No. WO 2006/057604 by Olson, for example.
  • the automatic delivery mechanism in a device for the delivery of medicament usually includes a compressed helical compression spring that drives a plunger rod forward as the spring decompresses upon activation of the device. In some designs, such springs work well.
  • a fully compressed helical spring provides a force that is large enough to overcome the static friction between the plunger and the inner wall of a container, so called break loose force, and the spring at its full extension, which is often not at its full decompression, provides a force that is large enough to complete the injection stroke but causing the probability of the container breakage.
  • a challenge in the design of such springs is balancing the need for sufficient force at the end of stroke against the need for a not-too-large force during storage (when the spring is fully compressed) that may overload the other components in the device.
  • Such other components may be made of plastics, glass or similar materials that have limited strengths.
  • the drive mechanism in such a device for the delivery of medicament should meet the following simultaneous goals: 1) exert enough force to overcome the “break loose” force of the container stopper and initiate delivery of the medication, 2) exert enough force to complete-the injection stroke, 3) meet goals 1) and 2) in an acceptable time frame (usually a few seconds), and 4) exert a low force during storage.
  • constant-force or variable springs are better able than compression helical springs to meet the design goals of injector devices, there is also a need to provide a smooth and reliable way to trigger the device to initiate the injection process. Visually indicating the start of the injection process and showing the progress of the injection are also important in the design of a medicament delivery device, such as an auto-injector.
  • the covering of the used needle should be automatic and nonreversible.
  • the design should not require the user to perform any manual manipulation of any component of the device, especially components located at the distal or needle end of the device. Our invention addresses these concerns while employing a variable force spring as the driving force to perform the injection.
  • One object of the present invention is to provide an automatic medicament or drug delivery device, which during delivery applies a predetermined sequence of at least two different force profiles to a container stopper, which ensures an optimal functionality of the device. This design lowers the risk of damaging the container and/or the device during medicament delivery and reduces the problems with plastic deformation of the plastic materials of the delivery device in comparison with prior art automatic medicament delivery devices.
  • Another object is to allow the user to control the manual insertion of the needle into the patient's skin while simultaneously pushing a needle shield into the device housing.
  • the retraction of the needle shield occurs as the syringe needle penetrates the skin.
  • the needle shield retraction is complete and the injector is automatically triggered. This is referred to as the “triggering point.”
  • Triggering or firing of the injector is achieved when one or more proximal extending beams on the needle shield engage cam surfaces on a rotatable latch. The camming action insures a smooth rotation of the latch and avoids the abrupt triggering exhibited by prior injector designs.
  • An uncoiled tensed plunger spring rewinds forcing a plunger rod to press against the syringe stopper, which begins the medicament delivery.
  • the plunger spring is part of the variable force drive mechanism of the injector and is preferably a variable force spring that can generate a predetermined sequence having at least two different force profiles only during a medicament delivery. Varying the wind, cradling, width or thickness of the band material of the spring or varying the Modulus of Elasticity of the material used to fabricate the spring can impact the force profiles of the sequence. Selecting the working material in different portions or laminating other materials onto a base material in different portions, etc. can also achieve this.
  • the predetermined sequence of the variable force spring comprises a last force profile, which is a profile where the force increases; therefore, the medicament delivery device will have an advantage of completely emptying all of the medicament a container or syringe.
  • the auto-injector of the present invention also contains a visual indication mechanism that reliably and positively provides visible information and feedback to the user that the injection process is progressing and when it is completed.
  • This visual indication mechanism comprises a flexible band arranged with different indications, wherein the band is rolled on a scroll and connected to the plunger on the opposite side of the scroll. When the plunger rod is released from its non-delivery state, the flexible band is pulled distally by the moving plunger assembly and indicates the status information to the user by the related printing on the flexible band.
  • Yet another object of the invention is the prevention of accidental needle sticks, which is achieved through a combination of a retractable needle shield and a rotator.
  • Longitudinal ribs arranged on an outside surface of the needle shield cooperate with grooves arranged on the inner sidewall of the rotator.
  • the rotator again slightly rotates in the same direction to cause alignment of one or more hard stops located at the distal end of the channels with one or more bearing surfaces located at the proximal end of the ribs.
  • This alignment prevents the rib (and the needle shield) from moving axially, thus preventing retraction of the needle shield and exposure to the used needle.
  • the combination of the hard stop and bearing surface of the rib form an irreversible lock of the needle shield.
  • a delivery device comprising an elongated housing, a container of medicament mounted within the housing having a slidable stopper, and a non-rotating plunger assembly in contact with the stopper.
  • the plunger rod has an indent and a longitudinal groove and is configured to move axially relative to the housing from a ready position and to an end-of-injection position.
  • a non-rotating needle shield axially slidable with respect to the housing that has an outer surface comprising a longitudinal rib terminating in a bearing surface, where the needle shield has a proximally extending beam and is configured to move from a partially extended position, to a retracted position and to a fully extended position.
  • the device also includes a rotator configured as a cylindrical tube having an open distal end and a proximal end wall, where the rotator is axially fixed inside the housing and is rotated through engagement with the rib to form an irreversible lock to prevent the needle shield from moving when in the fully extended position.
  • the rotator can also have a longitudinal channel on an inside surface configured to accept axial movement of the rib.
  • a through hole is provided in the proximal end wall to allow the needle shield beam to pass through to engage the latch.
  • the rotator channel preferably has straight and angled side walls configured to engage the rib when the rib moves in the proximal direction such that engagement of the bearing surface of the rib with the angled sidewall imparts a first biasing force that causes the rotator to rotate relative to the housing to a first position where the flexible tooth partially indexes from one ratchet tooth to an adjacent ratchet tooth.
  • the proximal end wall of the rotator preferably has a set of circumferentially arranged ratchet teeth configured to engage a flexible tooth on the latch carrier such that the engagement of the ratchet teeth with the flexible tooth creates a second biasing force urging the rotator to rotate from a first to a second position.
  • the partial indexing creates a rotational biasing force that ultimately causes the rotator to complete a second slight rotation that aligns the hard stop with the rib to lock out the needle shield.
  • the drive mechanism is powered by a coiled spring having a proximal distal end fixed axially relative to the outer housing and a proximal end attached to the plunger assembly such that the coiled spring is in an extended partially uncoiled tensed configuration having accumulated energy when the plunger assembly is in a cocked position.
  • a rotatable latch having a first position where the latch prevents the plunger assembly from moving axially and a second position where the latch is disengaged from the plunger assembly to allow the plunger to axially move distally relative to the latch, the rotator and the outer housing such that the accumulated energy is transferred to the plunger rod for driving the plunger rod and the stopper a predetermined axial distance within the container whereby the medicament within said container is delivered.
  • the latch has a cam configured to engage a bearing surface on a proximal end of the needle shield beam.
  • the cam can be configured with a cam angle such that proximal axial movement of the beam when engaged with the cam causes a smooth and non-abrupt rotation of the latch to rotate from the first position to the second position.
  • the latch preferably has through hole to accept axial movement of the plunger rod and has an inwardly projecting protrusion configured to engage an indent on the plunger rod when the latch is in the first position to prevent axial movement of plunger relative to the housing.
  • the plunger rod can also have a longitudinal groove configured to accept the protrusion when the latch is in the second position, thus allowing unimpeded axial movement of the plunger rod relative to and through the latch.
  • the proximal end of the housing comprises a window that allows a user to visually observe a scrolling tape that moves during the delivery of the medicament.
  • the device also can contain a latch carrier axially fixed to the housing, where the latch is rotatably positioned in the latch carrier and the latch carrier has a through hole to allow passage of the proximally extending beam on the needle shield as the needle shield moves in a proximal direction.
  • the needle shield is preferably connected to a biasing element that urges the needle shield to move distally such that a portion of the shield protrudes from the distal end of the housing when the plunger assembly is in the ready position.
  • a clicker mechanism generates an audible sound during the delivery of the medicament and preferably comprises a clicker arm on the plunger assembly that engages teeth on a clicker track that is axially fixed relative the outer housing.
  • the present invention includes a method of performing an injection comprising, in combination, the following steps,
  • the last force profile in the sequence is a profile where the force increases.
  • the variable force spring is a coil spring of band material and wherein the different force profiles are obtained by suitably adjusting the material and/or the geometry and/or the natural radius and/or the elastic modulus of the spring.
  • the variable force spring has one end attached to a latch carrier which is fixedly arranged to the housing and a second end, which is variably wound, cradled on the proximal end of the plunger.
  • FIG. 1 is a perspective view of an embodiment of the medicament delivery device according to the invention shown as an auto-injector in the fully assembled state;
  • FIG. 2 is a cross-sectional view of the embodiment of FIG. 1 in a partially disassembled state
  • FIG. 3 is a perspective exploded view of the embodiment of FIG. 1 in a disassembled state
  • FIG. 4 is a perspective view of the needle shield of the embodiment of FIG. 1 ;
  • FIG. 5 is a perspective view of the needle shield, plunger assembly, latch carrier and rotator of the embodiment of FIG. 1
  • FIG. 6 is a close-up perspective view looking distally of the plunger rod, latching carrier and latch;
  • FIG. 7 is a close-up perspective view looking proximally of the latch disassembled from the latch carrier.
  • FIG. 8 is a perspective exploded view of the proximal portion of the plunger assembly with the attached tape and spring.
  • distal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the delivery device, are located the closest to the medicament delivery site of the patient.
  • proximal part/end refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the delivery device, are located the farthest from the medicament delivery site of the patient.
  • the cap of the reusable auto-injection training device described herein is located at the distal end of the training injector and the ribbon window is located at the proximal end.
  • the term “container” encompasses all types of medicament containers that are commercially available that are suitable for injectable liquid compositions, including prefilled syringes, cartridges and ampoules.
  • the invention relates to an auto-injection device 1 as best shown in in FIGS. 1 & 3 comprising a housing or outer body 4 and a removable cap 2 .
  • Cap 2 includes a needle cover remover 2 a that is configured to grab and remove rigid cover 2 b and associated flexible needle cover 2 c from attachment to the distal end of syringe barrel 10 having fixed thereto needle 10 a when the cap 2 is pulled off housing 4 .
  • Housing 4 has window or cut-out 5 that allows visual observation of the syringe barrel 10 and slidable stopper 3 contained within the syringe barrel. As the medicament delivery process progresses a user can watch the stopper slide axially in the distal direction.
  • the outer body or housing 4 has a scroll window 6 located at the proximal end where the housing 4 is preferably comprised of an upper body housing 4 a and a lower housing body 4 b, each preferably comprising a thermoplastic material. These two body housings can be attached during manufacturing by pins, tongue & groove, snap fit, glue, fasteners, welding or any other known process to provide a secure connection.
  • a coiled spring 8 provides the driving force that moves plunger assembly 9 distally to move slidable stopper 3 within syringe barrel 10 to dispense medicament 10 b from needle 10 a.
  • One end of spring 8 i.e., the distal end 36 , is attached to latch carrier 15 through connectors 38 .
  • Latch carrier 15 is axially fixed to the lower housing 4 b such that there is no relative movement between the latch carrier 15 and the housing 4 . This provides a fixed or anchor position for the distal end 36 of plunger spring 8 .
  • spool 37 that is attached to the proximal end of spring 8 is fixed to the proximal end 9 b of the plunger assembly 9 , the spool 37 and attached spring 8 will move relative to the distal end 36 of the spring and the latch carrier 15 as it rewinds or coils to a relaxed state.
  • spring 8 is unwound from spool 37 and is in an extended state having accumulated energy stored therein. This unspooling or unwinding of the band material used to form spring 8 creates a tension or winding force in the plunger spring 8 tending to oppose the proximal setting movement of the plunger assembly during manufacturing and assembly of the device.
  • This winding force tends to pull the plunger assembly back in the opposite or distal direction in order to rewind, i.e., coiling, the spring around spool 37 .
  • This winding force is the driving force that allows the plunger rod 9 a to move distally during medicament delivery or in the case of the auto-injector embodiment illustrated, perform an injection.
  • Spring 8 is preferably a variable force spring and is not a traditional helical compression spring made from a helix of wire.
  • Spring 8 is preferably a flat or band spring formed in coil. More preferably spring 8 is not a constant-force spring (CFS).
  • CFSs force, or load, is a function of material width, thickness, and coil diameter. The load, which is directly proportional to the material width in a CFS and not directly proportional to material thickness, is given by the following expression:
  • spring 8 is preferably a variable-force spring (VFS) configured as a coil of band material that exerts a predetermined sequence of at least two different force profiles.
  • FFS variable-force spring
  • a first force profile is a profile where the force decreases as the spring relaxes.
  • a second force profile is a profile where the force increases as the spring relaxes.
  • a third force profile is a profile where the force is constant as the spring relaxes.
  • changing the radius of the coil, yielding a spring that exerts either increasing or decreasing force is advantageous in a wide range of products, including devices for delivery of medicament.
  • VFSs that exert a predetermined sequence of at least two different force profiles by modifying the other parameters in Eq. 1 , e.g., the physical shape of the spring. Increasing, either the material's thickness or the width or both.
  • the VFS is configured to yield a spring that generates an increasing force as the spring relaxed, i.e. coils. Varying the width of the material used to fabricate the VFS produces the desired load profile.
  • the parameters in Eq. 1 can be manipulated in various ways as necessary for the application of the VFS. For example, besides or instead of varying the width of the band material, it is possible to vary the material's thickness and/or the elastic modulus.
  • the load exerted by a VFS increases more by doubling the thickness than by doubling the width.
  • the elastic modulus in different portions of the material can be varied in many ways, for example by selectively working the material in such portions, laminating other materials onto a base material in such portions, etc.
  • a preferred approach is to vary the radius of the coil of the spring material.
  • the VFSs used in the present invention are advantageous to overcome problems due to siliconization profiles of the stopper syringe wall interface, especially at the end of the delivery stroke.
  • the VFSs described here enable the spring forces generated to match or compensate the break-loose and glide force profiles within the container generated by different manufacturers and processes better than conventional compression springs.
  • the plunger spring 8 is composed of spring steel, plastic with memory, or other material that can be unwound with an applied force during manufacturing and assembly of the auto-injector and has self-rewinding property that uses the stored applied force generated when the device is set to the ready to inject state.
  • the spring has a constant or variable force profile.
  • the spring of the present invention has a variable force profile comprising a constant force section of about 13N ⁇ 10% and variable force section that provides approximately 17.4N ⁇ 10% of force.
  • the springs used in present invention are also known as torsion flat springs that are typically made of metal because of the minimum amount of deformity and characteristic changes that occur using metal.
  • the common metal used is stainless steal or equivalent metal, which will have the precise repeatability of the desired force in a very short distance uncoiling motion while maintaining its full integrity and characteristic as it is repeatedly uncoiled and coiled with a specific constant torsion force.
  • These types of springs require less space than a compression spring made form a helix of wire and thus can be designed for placement in the device in very short and tight areas where a compression spring would not fit.
  • shield spring 7 Similar in design to the plunger spring 8 is shield spring 7 as shown in FIGS. 2-3 .
  • This spring 7 is used to bias the protective or needle shield 13 in a first stand-by position where the distal end 13 a, with attached shield ring 40 , protrudes out of the distal end 4 c of housing 4 .
  • the distal end 7 a of spring 7 is fixed to housing 4 b and the proximal end or the coil of spring 7 is fixed to a post or protrusion 13 c on the outer surface of shield 13 .
  • the shield springs 7 comprise two constant force springs. These springs can also be replaced by another kind of resilient means, e.g., a coil spring, a spiral spring.
  • Protective or needle shield 13 covers or shields the needle from the user's view and provides user protection from accidental needle sticks, both before and after the injection is completed.
  • Shield 13 is configured to slide axially relative to housing 4 , but is rotationally fixed relative the housing. To move the shield 13 from the stand-by or ready position to an activate or injection position, the user places the shield ring 40 against an injection site and pushes or moves the housing distally towards the injection site. This causes the needle shield 13 to slide or retract proximally relative and into the housing 4 until fingers or beams 29 engage latch 14 (see FIGS. 4 & 7 ).
  • the needle shield beams 29 have a bearing surface 29 a that contacts latch cam 31 on the angled cam surface 31 a in a bearing surface relationship where the angled cam surface slides and rotates relative to the bearing surface 29 a at the proximal end of the beam 29 . (see FIGS. 4 & 7 ). Since the needle shield 13 is rotationally fixed relative to the housing 4 , this bearing contact causes latch 14 to rotate counterclockwise when viewed in the proximal direction as shown in FIG. 7 . As shield 13 cannot rotate the fingers impart a rotating motion of latch 14 relative to latch carrier 15 , which is also rotationally and axially fixed to the housing 4 .
  • Latch 14 has a plunger through hole 14 a that has an inner surface generally matching the external diameter or shape of plunger rod 9 a. This inner surface has one or more radial extending protrusions or keys 24 extending inward and configured to engage plunger rod 9 a in either a key notch or indent 23 or a longitudinal slot or groove 22 . When two keys 24 are used as illustrated in FIG. 7 , there will be two notches 23 and two slots 22 , each preferably diametrically opposed from each other.
  • notch or indent 23 on plunger rod 9 a slides relative to protrusion 24 .
  • the protrusion 24 is positioned in longitudinal slot or groove 22 on plunger rod 9 a, which allows the plunger rod to move axially relative to the latch 14 positioned in latch carrier 15 .
  • the notch 23 will eventually become adjacent to protrusion 24 .
  • this will cause the latch protrusion 24 to rotate into notch 23 .
  • This notch or indent is positioned longitudinally along the plunger rod 9 a such that the latching of the protrusion and the notch 23 occurs when the plunger assembly 9 has reached the fully cocked position.
  • the plunger spring 8 is fully tensioned and urging the plunger assembly to move axially in the distal direction, the engagement of protrusion 24 with notch 23 prevents or prohibits axial movement in either direction.
  • the latch must rotate clockwise (when viewed distally) in order to disengage the protrusions 24 from the notches 23 to drop into and engage grooves 22 . This occurs, as previously described, when fingers 29 contact cams 31 and rotate latch 14 in the direction illustrated by the arrow.
  • the rotator 60 provides a safety feature to the device in that at the end of the delivery or injection sequence or process the rotator moves (rotates) relative to the housing 4 such that the needle shield 13 is irreversibly locked in a fully extended position covering the used needle.
  • the rotator provides a hard stop 64 as explained below that prevents the needle shield from retracting proximally into the housing. As such, the user and others are protected against accidental needle sticks.
  • one or more ribs 51 are located on the outside surface of needle shield 13 that terminate in a bearing surface 51 a. Preferably these ribs are integral to the shield and are formed during the molding process used to fabricate shield 13 .
  • the bearing surface 51 a first engages sidewall 62 a and then engages angle sidewall or ramp 63 . (see FIG. 5 ). Because the needle shield is rotatably fixed with respect to the housing it cannot turn so therefore the interaction of bearing surface 51 a with ramp 63 causes the rotator 60 to rotate slightly in the direction shown by the arrow 70 . With the bearing surface 51 a in channel 61 and the rotator now stationary, the needle shield rib 51 continues to travel along sidewall 62 b as shield 13 is further pushed or retracted into housing 4 moving proximally. Eventually, fingers or beams 29 will pass through a through hole 65 in the proximal end wall 68 of rotator 60 .
  • the needle shield reverses direction and starts to extend from the housing moving distally carrying ribs 51 along channel 61 in the reverse direction.
  • the bearing surface 51 a arrives at a point just outside of the distal end of channel 61 the needle shield is fully extended and covers the used needle.
  • the bearing surface 51 a is just outside of channel 61 allowing rotator 60 to further slightly rotate in the same direction as the first slight rotation such that the bearing surface 51 a becomes aligned with hard stop 54 located at the terminal or distal end of channel 61 .
  • the bearing surface 51 a would engage hard stop 64 and prevent any axial or retracting movement of the shield. In essence the combination of the bearing surface 51 a and hard stop 64 forms an irreversibly lock against retraction.
  • the rotator essentially makes two small rotations during the medicament delivery process from start to end. Biasing forces are needed to cause both rotations.
  • the first rotation results from the biasing force imparted by the bearing surface 51 a contacting angled sidewall 63 .
  • ratchet teeth 66 that are arranged circumferentially around a through hole that allows passage of plunger rod 9 a, move out of engagement with one or more flexible teeth 67 located on a distally projecting extension of latch carrier 15 .
  • This first rotation of the rotator is not large enough to fully index the flexible tooth 67 into an adjacent ratchet tooth.
  • This less than full indexing i.e., partial indexing, imparts a second biasing force on the rotator as a result of the flexible tooth urging the rotator to continue in rotation in the direction of the first slight rotation caused by the first biasing force imparted by rib 51 .
  • This second biasing force remains as ribs 51 travels proximally and then distally in channel 61 .
  • the second biasing force causes the rotator to complete the second slight rotation such that the hard stop 64 becomes in axially alignment with bearing surface 51 a. This second rotation of the rotator completes the formation of the irreversible lockout of the needle shield 13 .
  • plunger spring 8 provides the driving force to move plunger assembly 9 axially in the distal direction when the medicament delivery device is fired or triggered by the user.
  • No trigger button or switch is required to fire device 1 and, as such, there is no mechanism in the device that requires manipulation using the user's fingers to push, flip, de-latch, or otherwise activate in order to fire the device. All that is required to trigger the injection procedure is to press the shield 13 against an injection site.
  • the medicament container or pre-filled syringe 10 as illustrated in FIG. 3 is positioned in and held axially fixed by carrier 11 .
  • Carrier 11 is required because it provides an additional housing component for the syringe as well as an axial alignment feature for the syringe shield.
  • the carrier also allows the medicament container to be held in a position where the container will have minimum rotation and or movement as a result of the activation or deactivation phases and repeated actions by a user.
  • a syringe collar 55 is disposed between the syringe finger flanges 56 and carrier 11 . (see FIG. 2 ). This collar provides a damping force or cushioning effect between the syringe and the carrier to avoid breakage of the syringe or the delivery device.
  • the collar is preferably fabricated of a thermoplastic elastomer (TPE) or some other soft plastic that can absorb medicament delivery forces generated by spring 8 .
  • TPE thermoplastic elastomer
  • the medicament delivery device of our invention also generates an audible noise or signal to the user as the injection proceeds from the start to the end.
  • This audible feature is achieved preferably by the use of a clicker track 17 fixed to the housing 4 b and engaged by a flexible clicker arm 21 attached to plunger assembly 9 .
  • a preferred configuration uses two clicker arms 21 and two clicker tracks 17 diametrically opposed to each other.
  • One clicker track is axially fixed and parallel to the longitudinal axis of the inside surface of housing 4 b and the other clicker track is similarly axially fixed to the inside surface of housing 4 a.
  • One clicker arm 21 is located on the top portion of plunger assembly 9 as shown in FIG.
  • the clicker arm (not visible) is located on the underside or bottom of the proximal end 9 b of plunger assembly 9 to engage the clicker track 17 shown in FIG. 8 .
  • the clicker arm engages the clicker track and rides up and over the teeth positioned longitudinally along the track 17 causing a “clicking” sound that is heard by the user.
  • the teeth separation and configuration is selected such that each click preferably matches the delivery of a unit dose of the medicament from the pre-filled container.
  • the design of the clicker arm 21 and clicker track 17 must take into account the setting of the device during assembly and, as such, must allow the plunger assembly to move in the opposite proximal direction during setting.
  • the engagement of the clicker arm and clicker track must not be unidirectional, but instead must be bidirectional.
  • Another feature of the clicker is that once the noise stops the user will know that the injection is complete or that the device has been fully set during assembly.
  • the clicker track can have larger or different shaped teeth or a tooth at the distal end such that as the plunger assembly finishes moving distally the clicker arm will engage the larger/different tooth and make a louder or different noise signifying the end of the injection process.
  • the scroll window 6 located at the proximal end of housing 4 allows the user to watch a moving scroll of tape 33 unwind as the injection procedure is in progress.
  • the window can be comprised of any clear, transparent or translucent material that will allow the user to see movement of tape 33 .
  • the window is constructed or formed as a lens to magnify the appearance of tape 33 .
  • the observation of the moving tape 33 provides a visual signal to the user of when injection begins, as it progresses, and when the injection ends.
  • the progress scroll or tape 33 is mounted on scroll spindle 20 as illustrated in FIG. 2 .
  • the tape 33 contains indicia 34 that provide the user with a visual signal through window 6 that the tape is moving in the direction of the arrow in FIG. 8 as the injection progresses.
  • Spindle 20 is fixed to lower housing 4 b and is prevented from moving axially, but is allowed to rotate about the stationary fixed axial position.
  • the end of the tape opposite spindle 20 is fixed or attached to plunger assembly 9 and moves axially in the distal direction as shown by the arrow in FIG. 8 during activation of the delivery or injection process.
  • plunger assembly 9 moves distally it pulls tape 33 in the direction of the arrow thus unwinding the tape from spindle 20 and preferably revealing indicia 34 , which in turn shows the user movement of the tape signaling that the injection process is progressing.
  • the tape 33 has been unwound from spindle 20 but remains connected to the spindle.
  • tape 33 is composed of a material that is resilient and has memory, like spring steel or a plastic composite with memory, such that as the plunger assembly 35 is set during manufacturing and assembly of the device, the tape will wind onto the spindle to the starting position.
  • This winding process is analogous to that used in hand held tape measures that have automatic rewind features.
  • the spindle may be connected to a biasing assembly or component, such as a spring, such that the biasing component is stressed or tensioned as the tape is unwound. During the initial setting of the plunger assembly such a biasing component causes the spindle to reverse rotation direction and winds the tape to the starting position.

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US16/548,497 Active 2036-06-13 US11318260B2 (en) 2014-03-06 2019-08-22 Device and method for delivering a medicament
US17/725,202 Pending US20220241519A1 (en) 2014-03-06 2022-04-20 Device and method for delivering a medicament
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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160193415A1 (en) * 2013-08-05 2016-07-07 Owen Mumford Limited Injection Devices
US20190328968A1 (en) * 2017-01-20 2019-10-31 L.G.P. Technology Holdings Llc Auto-injector device
US20200258424A1 (en) * 2017-02-07 2020-08-13 Noble International, Inc. Injection simulation device and method
US20210093790A1 (en) * 2015-06-03 2021-04-01 Sanofi-Aventis Deutschland Gmbh Drug Delivery Device
US11357925B2 (en) * 2017-04-28 2022-06-14 Nemera La Verpillière Automatic injection device provided with a device for generating sound signals
US11471599B2 (en) * 2015-11-19 2022-10-18 Shl Medical Ag Medicament delivery device

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101868273B (zh) 2007-10-02 2014-10-15 莱蒙德尔有限公司 外部药泵
EP2399635A1 (en) 2010-06-28 2011-12-28 Sanofi-Aventis Deutschland GmbH Auto-injector
WO2016202555A1 (en) * 2015-06-19 2016-12-22 Carebay Europe Ltd Medicament delivery device
US10576207B2 (en) 2015-10-09 2020-03-03 West Pharma. Services IL, Ltd. Angled syringe patch injector
CN108472438B (zh) 2015-10-09 2022-01-28 西医药服务以色列分公司 至预填充的流体储存器的弯曲流体路径附加装置
US11311674B2 (en) 2016-01-21 2022-04-26 West Pharma. Services IL, Ltd. Medicament delivery device comprising a visual indicator
US10646643B2 (en) 2016-01-21 2020-05-12 West Pharma. Services IL, Ltd. Needle insertion and retraction mechanism
EP3711793B1 (en) 2016-01-21 2021-12-01 West Pharma Services IL, Ltd. A method of connecting a cartridge to an automatic injector
US11389597B2 (en) 2016-03-16 2022-07-19 West Pharma. Services IL, Ltd. Staged telescopic screw assembly having different visual indicators
USD830538S1 (en) * 2016-05-04 2018-10-09 Nuance Designs Of Ct, Llc Autoinjector
USD831822S1 (en) * 2016-05-17 2018-10-23 Nuance Designs Of Ct, Llc Autoinjector
US10792432B2 (en) * 2016-06-09 2020-10-06 Becton, Dickinson And Company Drive assembly and spacer for drug delivery system
EP3490643B1 (en) 2016-08-01 2021-10-27 West Pharma. Services Il, Ltd. Anti-rotation cartridge pin
CN109890441B (zh) * 2016-10-13 2021-05-25 艾斯曲尔医疗公司 用于药剂输送装置的护帽组件
EP3323448A1 (en) * 2016-11-18 2018-05-23 Carebay Europe Ltd. Medicament delivery device
FR3058895B1 (fr) * 2016-11-23 2024-01-12 Nemera La Verpilliere Dispositif d'injection presentant un dispositif de retrait de capuchon de seringue ameliore
WO2018134385A1 (en) 2017-01-23 2018-07-26 Sanofi Drive train for dial of a torsion-spring assisted wind-up injection device
WO2018166985A1 (en) 2017-03-13 2018-09-20 Sanofi-Aventis Deutschland Gmbh Drug delivery device
JP6921997B2 (ja) 2017-05-30 2021-08-18 ウェスト ファーマ サービシーズ イスラエル リミテッド ウェアラブル注射器のモジュラ駆動トレイン
TWI678221B (zh) * 2017-09-28 2019-12-01 瑞士商瑞健醫療股份有限公司 驅動單元
USD890332S1 (en) 2018-02-08 2020-07-14 Nuance Designs Of Ct, Llc Autoinjector
CN108478908B (zh) * 2018-05-07 2024-04-26 吉林大学 一种仿生无痛注射器针头
KR102263999B1 (ko) * 2019-04-30 2021-06-10 재단법인 아산사회복지재단 의료기기용 혈액 압력조절장치
BR112022005996A2 (pt) * 2019-09-30 2022-07-12 Amgen Inc Dispositivo de administração de fármaco
CN111701116B (zh) * 2020-07-31 2023-08-18 派格生物医药(苏州)股份有限公司 一种注射器械
WO2023083616A1 (en) * 2021-11-09 2023-05-19 Shl Medical Ag Medicament delivery device with click generator
WO2023180518A1 (en) 2022-03-25 2023-09-28 Becton Dickinson France Automatic injection device

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006057604A1 (en) * 2004-11-24 2006-06-01 Shl Medical Ab Injection device
US20090112163A1 (en) * 2007-10-31 2009-04-30 Bivin Donald B Fluid delivery device with variable force spring
WO2010066592A2 (en) * 2008-12-12 2010-06-17 Shl Group Ab Medicament delivery device

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5478316A (en) 1994-02-02 1995-12-26 Becton, Dickinson And Company Automatic self-injection device
US6183464B1 (en) 1998-06-01 2001-02-06 Inviro Medical Devices Ltd. Safety syringe with retractable needle and universal luer coupling
DE10240166A1 (de) 2002-08-30 2004-03-18 Disetronic Licensing Ag Vorrichtung zur kontrollierten Ausschüttung einer injizierbaren Flüssigkeit
AU2003265179B2 (en) 2002-09-24 2008-07-31 Shl Medical Ab Injecting device
JP4934051B2 (ja) * 2004-11-24 2012-05-16 エスホーエル メディカル アクチボラゲット 注射器具
US7955304B2 (en) 2005-07-15 2011-06-07 Shl Group Ab Injector
WO2009010591A2 (en) 2007-07-19 2009-01-22 Shl Group Ab Automatic device for delivering a medicament
EP2198903A1 (en) * 2008-12-19 2010-06-23 Sanofi-Aventis Deutschland GmbH Motor mechanism for a drug delivery device and drug delivery device
EP2566538B1 (en) * 2010-05-07 2020-03-18 SHL Medical AG Medicament delivery device
CA2848242C (en) * 2011-09-09 2019-12-24 Merck Patent Gmbh Reloadable auto-injector

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006057604A1 (en) * 2004-11-24 2006-06-01 Shl Medical Ab Injection device
US20090112163A1 (en) * 2007-10-31 2009-04-30 Bivin Donald B Fluid delivery device with variable force spring
WO2010066592A2 (en) * 2008-12-12 2010-06-17 Shl Group Ab Medicament delivery device

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160193415A1 (en) * 2013-08-05 2016-07-07 Owen Mumford Limited Injection Devices
US10183121B2 (en) * 2013-08-05 2019-01-22 Owen Mumford Limited Injection devices
US20210093790A1 (en) * 2015-06-03 2021-04-01 Sanofi-Aventis Deutschland Gmbh Drug Delivery Device
US11471599B2 (en) * 2015-11-19 2022-10-18 Shl Medical Ag Medicament delivery device
US20190328968A1 (en) * 2017-01-20 2019-10-31 L.G.P. Technology Holdings Llc Auto-injector device
US10881795B2 (en) * 2017-01-20 2021-01-05 L.G.P. Technology Holdings Llc Auto-injector device
US20200258424A1 (en) * 2017-02-07 2020-08-13 Noble International, Inc. Injection simulation device and method
US11694576B2 (en) * 2017-02-07 2023-07-04 Noble International, Inc. Injection simulation device and method
US11357925B2 (en) * 2017-04-28 2022-06-14 Nemera La Verpillière Automatic injection device provided with a device for generating sound signals

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AU2015226256A1 (en) 2016-08-18
US20190374728A1 (en) 2019-12-12
US20220241519A1 (en) 2022-08-04
WO2015132234A1 (en) 2015-09-11
KR101902668B1 (ko) 2018-09-28
EP3113810B1 (en) 2020-07-08
US11318260B2 (en) 2022-05-03
US20170080163A1 (en) 2017-03-23
TWI616218B (zh) 2018-03-01
JP2017506975A (ja) 2017-03-16
US10434262B2 (en) 2019-10-08
KR20160117594A (ko) 2016-10-10
TW201544132A (zh) 2015-12-01
JP6373398B2 (ja) 2018-08-15
AU2015226256B2 (en) 2017-06-15
EP3113810A1 (en) 2017-01-11
US20230112983A1 (en) 2023-04-13
CN106068135A (zh) 2016-11-02

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