WO2014029621A1 - Automatic injection device - Google Patents

Automatic injection device Download PDF

Info

Publication number
WO2014029621A1
WO2014029621A1 PCT/EP2013/066542 EP2013066542W WO2014029621A1 WO 2014029621 A1 WO2014029621 A1 WO 2014029621A1 EP 2013066542 W EP2013066542 W EP 2013066542W WO 2014029621 A1 WO2014029621 A1 WO 2014029621A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
injection device
proximal end
medicament injection
hider
Prior art date
Application number
PCT/EP2013/066542
Other languages
French (fr)
Inventor
Stefan HÖGDAHL
Original Assignee
Carebay Europe Ltd
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 to JP2015527845A priority Critical patent/JP6510408B2/en
Application filed by Carebay Europe Ltd filed Critical Carebay Europe Ltd
Priority to PL13753824.5T priority patent/PL2885026T3/en
Priority to ES13753824T priority patent/ES2967357T3/en
Priority to CA2882229A priority patent/CA2882229C/en
Priority to CN201380051098.7A priority patent/CN104684603B/en
Priority to AU2013305182A priority patent/AU2013305182B2/en
Priority to EP13753824.5A priority patent/EP2885026B1/en
Priority to US14/422,474 priority patent/US10052436B2/en
Priority to KR1020157006866A priority patent/KR101694645B1/en
Publication of WO2014029621A1 publication Critical patent/WO2014029621A1/en
Priority to IL23727015A priority patent/IL237270B/en
Priority to ZA2015/01128A priority patent/ZA201501128B/en
Priority to IN448KON2015 priority patent/IN2015KN00448A/en

Links

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
    • A61M5/2033Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3243Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M5/46Devices 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
    • 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
    • A61M2005/2006Having specific accessories
    • A61M2005/202Having specific accessories cocking means, e.g. to bias the main drive spring of an injector
    • 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
    • A61M2005/206With automatic needle insertion
    • 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
    • A61M2005/2073Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403Ampoule inserted into the ampoule holder
    • A61M2005/2407Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2433Ampoule fixed to ampoule holder
    • A61M2005/2437Ampoule fixed to ampoule holder by clamping means
    • 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
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2485Ampoule holder connected to rest of syringe
    • A61M2005/2488Ampoule holder connected to rest of syringe via rotation, e.g. threads or bayonet
    • 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
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • A61M5/3204Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices

Definitions

  • the present invention relates to an injection device, especially a reusable auto injector.
  • Reusable auto injectors which can be loaded with a container subassembly, such as a syringe, are known in the prior art.
  • US-5599309 discloses an auto injector for use with proprietary syringes.
  • That prior art discloses a device comprising a drive member that receives the rear end of a plunger of a syringe and a trigger for releasing the drive member such that a medicament can be injected.
  • Drawbacks with that prior art are that needle is outside the device and visible to the user after the device has been removed from the injection site and that the re-loading is complicated and time consuming.
  • This object and other objects are solved by an injection device as defined in claim 1 .
  • This object and other objects are also solved by a method as defined in claim 15.
  • Preferred embodiments of the present invention are defined in the dependent claims.
  • a medicament injection device having a proximal end and a distal end and being arranged to receive a replaceable container subassembly having a medicament container with a plunger therein, a needle and a needle shield.
  • the medicament injection device comprises a front housing and a rear housing which are releasably connectable to each other and a reloadable drive mechanism is accommodated in the rear housing for acting on the replaceable container subassembly.
  • the reloadable drive mechanism is moveable between a cocked and an extended position and a release mechanism is provided for releasing the drive mechanism from said cocked position to said extended position.
  • a needle hider front is slidably arranged within the front housing.
  • a needle shield remover is arranged to connect with a needle shield of the replaceable container subassembly received in the reloadable medicament injection device, wherein the needle shield remover is arranged to be removably inserted into a proximal end of the front housing through the needle hider front.
  • the needle shield remover when inserted into the front housing is adapted to be used to interact with the reloadable drive mechanism accommodated in said rear housing such that a user can relocate the reloadable drive mechanism from said extended position to said cocked position.
  • the use of the device is simplified and improved to a large extent.
  • a user simply has to release the front housing from the rear housing, replace the needle shield remover and then turn the front housing 180 degrees and use the needle shield remover to push the drive mechanism from its proximal, extended position to its distal, cocked position.
  • the needle can be kept out of sight of a user. Many users prefer not to see the needle, neither during use, nor when the device is not used.
  • a needle hider body is arranged within the front housing and the needle hider front is adjustably connected to the needle hider body by means of a threaded connection. This assures that the needle is kept out of sight at all times.
  • the needle shield remover and the needle hider front are arranged to mate with each other such that axial movement of the needle shield remover relative to the needle hider front is allowed while rotation of the needle shield remover relative to the needle hider front is prevented.
  • This arrangement allows a user to use the needle shield remover to adjust the axial position of the needle hider front which is connected by a threaded connection to the needle hider body by holding the front housing while turning the needle shield remover.
  • the needle hider body is axially moveable within the front housing between a proximal end position and a distal end position and wherein a syringe guide is arranged within said needle hider body for receiving a replaceable container subassembly, said syringe guide being axially moveable between a proximal end position and a distal end position relative to the front housing and wherein a proximal end surface of the syringe guide defines a maximum insertion depth for the needle shield remover.
  • the proximal end surface of the syringe guide defines the maximum insertion depth of the needle shield remover and acts as an abutment such that the front housing can be used to relocate the drive mechanism in the rear housing.
  • a first biasing member is arranged between the syringe guide and the needle hider body. This first biasing member biases the syringe guide towards said distal end position and the needle hider body towards said proximal end position. The first biasing member ensures that the needle hider moves out and covers the needle as soon as the injection device is removed from the injection site such that the needle never will be visible to the patient.
  • a resilient syringe collar is arranged at a distal end of the syringe guide, said resilient syringe collar being adapted to receive and hold a replaceable container subassembly.
  • the resilient syringe collar made from e.g. rubber, will make sure that the replaceable container subassembly is firmly held in place while still being replaceable.
  • the front housing comprises internal abutment surfaces defining said proximal end positions and distal end positions for the needle hider body and the syringe guide relative to the front housing.
  • the penetration depth of a needle of a container subassembly received in the reloadable medicament injection device is adjusted by adjusting the position of the needle hider front.
  • the threaded connection of the needle hider front to the needle hider body is a simple solution providing an adjustable penetration depth.
  • the needle hider front comprises indication means presenting a set needle penetration depth.
  • the indication means can be in the form of numerals visible in a window or opening in the front housing clearly indicating the currently set penetration depth.
  • the needle shield remover comprises flexible hook means arranged to grasp the needle shield of a replaceable container subassembly received in the reloadable medicament injection device.
  • the flexible hook means When the needle shield remover is inserted into the proximal end of the front housing through the needle hider front the flexible hook means will deflect over the outer surface of the needle shield and as soon as the flexible hook means passes the distal end of the needle shield they will flex back to a less biased position and the hook means, preferably provided with a fluke, or barbed element, will securely grasp the needle shield such that when the needle shield remover is pulled out of the front housing, the needle shield will be pulled off the container subassembly received in the medicament injection device.
  • the reloadable drive mechanism comprises an axially moveable plunger rod driver and a drive spring biasing the plunger rod driver towards the proximal end position.
  • the plunger rod driver and the rear housing comprise corresponding guide means for guiding the plunger rod driver during movement within the rear housing.
  • the plunger rod driver is configured to act on the plunger of the replaceable container subassembly for moving axially said replaceable container subassembly in relation to the front housing such that said needle is penetrated and said medicament is expelled through said needle.
  • the plunger rod driver is configured to act directly on the plunger when the plunger rod driver may comprise a plunger rod or indirectly through a plunger rod which is part of the container subassembly.
  • the rear housing comprises a button blocker moveable within the rear housing between a proximal end position, in which the button blocker prevents the release mechanism from releasing the drive mechanism from said cocked position to said extended position, and a distal end position, in which the button blocker allows the release mechanism to release the drive mechanism from said cocked position to said extended position, wherein the button blocker is moved from said proximal end position to said distal end position when the needle hider body is axially moved within the front housing from said proximal end position to said distal end position.
  • the button blocker is released only when the needle hider body is pushed towards a distal end position, e.g.
  • a second biasing member is provided within the rear housing biasing the button blocker towards said proximal end position. This ensures that as soon as the plunger rod driver is pushed back to its distal end position, the button blocker will assume its proximal end position where release of the drive mechanism is prevented.
  • a method for reloading a medicament injection device according to the first aspect of the invention.
  • a user removes the front housing from the rear housing having the needle shield remover arranged at the front housing through the needle hider front, and brings the proximal end of the needle shield remover in contact with a proximal end of the reloadable drive mechanism accommodated in said rear housing and subsequently moves the reloadable drive mechanism from said extended position to said cocked position by pushing said front housing and said needle shield remover axially towards said rear housing and said drive mechanism.
  • Fig. 1 a is a schematic perspective view of an embodiment of the medicament delivery device according to the invention in a disassembled state.
  • Fig. 1 b is a schematic perspective view of an embodiment of the medicament injection device according to the invention in an assembled state.
  • Fig. 2a is a schematic exploded perspective view of an embodiment of the rear housing of the medicament injection device according to the invention.
  • Fig. 2b is a schematic exploded perspective view of an embodiment of the rear housing of the medicament injection device according to the invention.
  • Fig. 3 is a schematic perspective cross-section of an embodiment of the front housing of the medicament injection device according to the invention.
  • Fig. 4 is a schematic perspective view of an embodiment of the front housing of the medicament injection device according to the invention.
  • Figs. 5a and 5b is a schematic perspective view of method steps according to the invention.
  • Fig. 6a, 6b, 7a and 7b are schematic perspective cross-sections of an embodiment of the medicament injection device according to the invention.
  • the term “container” encompasses all types of containers suitable for injectable liquid composition. Concerning the terms “distal” and “proximal” they refer to points which are further away and closer to the injection site respectively.
  • a medicament injection device 100 comprises a rear housing 101 made from e.g. thermoplastic, a front housing 102 and a replaceable container subassembly 103, such as a syringe.
  • the rear and front housings 101 , 102 are connectable to each other by e.g. a twisting coupling.
  • the front and rear housings 101 , 102 can be connected and disconnected by a 90 degree relative twist of the housings 101 , 102.
  • the replaceable container subassembly 103 may comprise a needle (not shown in figure 1 a), a medicament container 15, a plunger 14, a plunger rod 13 and a needle shield 1 1 arranged to protect users from the needle. Obviously, it is also imaginable that the container subassembly 103 lacks a plunger rod 13 and that this plunger rod is part of the device.
  • Figures 2a and 2b disclose the rear housing 101 comprising the drive mechanism 108.
  • the drive mechanism 108 comprises a plunger rod driver 1 arranged axially moveable within the rear housing 101 between a proximal end position (shown in figure 2a) and a distal end position (shown in figure 2b).
  • the proximal end position of the plunger rod driver 1 corresponds to a position where the plunger rod 13 and the plunger 14 of the replaceable container subassembly 103 have been pressed to the end of its stroke, i.e.
  • the medicament container 15 has been emptied, and the distal end position of the plunger rod driver 1 corresponds to a position where the plunger rod 13 and the plunger 14 of the replaceable container subassembly 103 have not yet been moved, i.e. the medicament container 15 is full.
  • the mechanism 108 further comprises a drive spring 2, here in the form of a helical coil spring, which biases the plunger rod driver 1 towards its proximal end position.
  • a release mechanism 3 for releasing the plunger rod driver 1 of the drive mechanism 108 from the distal, or cocked, position to the proximal, or extended, position is arranged at an upper surface of the rear housing 101 .
  • the release mechanism 3 is pivotable around a pivoting axle 6 between an extended position (shown in figure 2b) and a depressed position (shown in figure 2a) and comprises a trigger button 4 and an abutment member 5 which abuts and interworks with the plunger rod driver 1 .
  • the release mechanism 3 has been depressed and the plunger rod driver 1 has adopted its extended, proximal end position. In this position the abutment member 5 abuts an upper surface of the plunger rod driver 1 and prevents the release mechanism 3 from pivoting back around pivot axle 6.
  • the design of the details imply that as long as the plunger rod driver 1 is not in its distal end position, the release mechanism 3 cannot assume its extended position but is instead locked in the depressed position.
  • a resilient member (not shown in the figures) is provided biasing the trigger button 4 towards its extended position which means that when the interaction between the plunger rod driver 1 and the release mechanism 3 allow for it, i.e.
  • a status window 7 is arranged through which symbols provided on the plunger rod driver 1 are visible to indicate the status of the medicament delivery device 100.
  • the status window is preferably made of a transparent, or at least translucent, plastic material.
  • the rear housing 101 can be made up of two halves which are secured to each other by means of pins or projections 8 provided at one of the halves and corresponding openings 8' (not shown in figures 2a or 2b) in the other halves.
  • Interacting guide means 10 are provided on an outer surface of the plunger rod driver 1 and an internal surface of the rear housing 101 guiding the plunger rod driver 1 during its movement within the rear housing 101 .
  • Figure 3 shows a cross-section of a front housing 102 provided with a replaceable container subassembly in the form of a syringe 103 and a needle shield remover 109 partially arranged at a proximal end of the front housing 102 and grasping a needle shield 1 1 encompassing a needle 12 of syringe 103.
  • the syringe 103 further comprises a plunger rod 13, a plunger 14 and a medicament container 15.
  • a needle hider front 16 is provided at a proximal end of the front housing connected to a needle hider body 17 by means of a threaded connection 18, more specifically the needle hider front 16 is provided on the needle hider body 17.
  • the needle shield remover 109 comprises a proximal and a distal end, wherein the distal end is arranged at the proximal end of the front housing 102 through the needle hider front 16.
  • the threaded connection 18 provides a user with a possibility of adjusting the penetration depth of needle 12 during use.
  • the needle hider body 17 extends through the inside of the front housing 102 and encompasses the syringe 103. The purpose of the needle hider body 17 and the needle hider front is to hide the needle from a user, both during and between uses of the device.
  • the needle hider body 17 and front housing 102 are provided with corresponding abutment surfaces 20, 21 which define the distal and proximal end positions of the axial movement of needle hider body 17 relative to the front housing 102.
  • This relative axial movement in combination with the adjustability of the needle hider front 16 ensures that the needle 12 is kept non-visible at all time.
  • a syringe guide 24 is arranged within front housing 102, more specifically within the needle hider body 17, axially moveable between a distal end position and a proximal end position relative to the front housing 102.
  • the proximal end position is defined by corresponding abutment surfaces (not shown) provided on an internal surface of the front housing 102 and on the external surface of the syringe guide 24 respectively.
  • the abutment surfaces provided on the front housing 102 and on the syringe guide 24 will typically have to extend through openings or slots provided in the needle hider body 17 in order to connect with each other. These abutment surfaces in
  • the needle shield remover 109 is configured to be partially inserted i.e. axially movable into the proximal end of the front housing 102 through the needle hider front 16 and through the needle hider body 17.
  • a resilient syringe collar 25 typically made of rubber, is arranged at a distal end of the syringe guide 24 for receiving and holding the syringe 103. The resilient material will securely hold the syringe in place while still allowing it to be replaced after it has been emptied. Normally, the resilient syringe collar 25 will stay in its position in the syringe guide during
  • a first biasing member 19 is arranged between the syringe guide 24 and the needle hider body 17 which biases the syringe guide 24 towards its distal end position and the needle hider body 17 towards its proximal end position.
  • the first biasing member 19 ensures that as soon as the device according to the invention is removed from the injection site, the needle hider body, and thus also the needle hider front 16, automatically travel outwards keeping the needle 12 out of sight to a user.
  • the front housing 102 can be made up of two halves which are secured to each other by means of pins or projections 8 (not shown in figure 3) provided at one of the halves and corresponding openings 8' in the other halves.
  • other solutions are imaginable, such as tongue and groove solutions; snap catch elements; or even permanent securing by welding or gluing.
  • Needle shield remover 109 is provided with axially running protrusions 23 having a corresponding shape to recesses 22 provided in the needle hider front 16. This means that the needle shield remover 108 can be inserted axially into needle hider front 16 while any relative rotational movement between the two is prevented.
  • the needle shield remover 109 as a grip element, a user can adjust the position of the needle hider front 16 relative to the needle hider body 17 by turning, thus setting the penetration depth of the needle 12 during use.
  • the front housing 102 and/or the needle hider body 17 may be provided with means defining a number of pre-set positions which snap in place when the needle hider front 16 is turned.
  • the needle hider front 16 is provided with digits 26 visible in a cut-out, window 29 or similar provided at the front housing 102 indicating a set penetration depth. The penetration depth can be adjusted back and forth until a desired value has been set.
  • FIGs 5a and 5b schematically show how the drive mechanism of the device 100 is reloaded.
  • the front housing 102 having the needle shield remover 109 attached at its front end through the needle hider front 16 is removed from the rear housing 101 by twisting the housings 90 degrees relative to each other.
  • the proximal end of the needle shield remover 109 is positioned abutting the drive mechanism 108 arranged in the rear housing 101 and situated in its proximal end position.
  • the front housing together with the needle shield remover 109 is used to force the drive mechanism 108 towards its proximal end position where it will snap into a cocked position, ready to be used.
  • FIG. 6a, 6b, 7a and 7b A more detailed explanation of the functioning of the device will be provided with respect to figures 6a, 6b, 7a and 7b below.
  • Figure 6a shows the device loaded with a fresh syringe and in a cocked position, i.e. drive spring 2 is completely compressed such that the drive mechanism 108 is loaded but release mechanism 3 is prevented from releasing the plunger rod driver 1 .
  • This is realized by the button blocker 26 reaching from a proximal part of the rear housing 101 to a distal part of the rear housing 101 where it prevents the trigger button 4 from being depressed and releasing the drive mechanism 108.
  • the button blocker 26 is moveable between a proximal and a distal position defined by the openings 8' provided in the rear housing 101 .
  • Abutment member 5 of the release mechanism 3 reaches into recess 9 of the plunger rod driver 1 and prevents it from moving forward towards its proximal end position.
  • the needle shield remover 109 is still in place grasping needle shield 1 1 and it can be used to set a desirable penetration depth.
  • the needle hider front has been set in a position corresponding to maximum penetration depth and the needle shield remover 109 has subsequently been pulled out together with the needle shield 1 1 .
  • the device 100 is now in position corresponding to when a user presses it against the intended injection site by which the needle hider body 17 and needle hider front 16, have assumed the distal end position, where abutment surfaces 20, 21 come in contact with each other.
  • the needle hider body 17 Upon pressing the device against the injection site, the needle hider body 17 also comes into contact with the button blocker 26. As the needle hider body 17 travels backwards, towards the distal end position, it forces the button blocker 26 axially relative to the rear housing towards a distal end position. This movement of the button blocker 26 allows the release mechanism 3 to be activated and the device 100 is now ready to start the injection.
  • the trigger button 4 has been depressed, causing the plunger rod driver 1 to be forced forwards by drive spring 2 and thereby moving the syringe 103 and syringe guide 24 towards the proximal end position of the syringe guide 24.
  • FIG. 7b corresponds to a state where a user has removed the device from the injection site after completed injection. As soon as this is done, the first biasing member 19 extends and needle hider body 17 assumes its proximal end position thus effectively hiding the needle 12 from being visible to a user.
  • a second biasing member 27 is provided between the rear housing 101 and the button blocker 26 which, when the drive mechanism 108 is forced to its distal end position and the release mechanism assumes its extended position (see description referring to figures 2a and 2b), will force the button blocker 26 to assume its proximal end position thus preventing the trigger button 4 from being depressed.
  • a spring guide 28 which supports and guides drive spring 2 in order to avoid buckling of drive spring 2 during compression.
  • the drive mechanism can in a simple and reliable manner be reloaded by using the front housing and the needle shield remover of the device itself.
  • the needle hider front is biased and always covers the needle such that the needle never will be visible to the patient.
  • Penetration depth can also be set in a very simple and user-friendly manner. By using the needle shield remover as a grip, also users with reduced strength and/or co-ordination will be able to do this.
  • the indication means of the present invention will in a clear and concise manner present a set penetration depth.
  • the set penetration depth will not have to be re-set for each injection occasion; instead the device according to the present invention provides an automatic penetration depth memory.
  • the device is re-usable and the user can change the emptied syringe to a new in a simple manner.
  • the device allows for a variable penetration depth and the setting of the dose can be set downwardly and upwardly until a required depth has been set.

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Abstract

The present invention relates to a medicament injection device (100) arranged to receive a replaceable container subassembly (103) The medicament injection device (100) comprises a front housing (102) and a rear housing (101) releasably connectable to each other. A reloadable drive mechanism (108) is accommodated in the rear housing (101) for acting on the plunger (14) of a replaceable container subassembly (103) for expelling medicament. A needle hider front is slidably arranged within the front housing. A needle shield remover (109) is arranged to connect with a needle shield of the replaceable container subassembly, wherein the needle shield remover is arranged to be removably inserted into a proximal end of the front housing through the needle hider front. The needle shield remover is adapted to be used to interact with the reloadable drive mechanism accommodated in the rear housing such that a user can reload the drive mechanism.

Description

AUTOMATIC INJECTION DEVICE
FIELD OF THE INVENTION
The present invention relates to an injection device, especially a reusable auto injector.
BACKGROUND OF THE INVENTION
Reusable auto injectors which can be loaded with a container subassembly, such as a syringe, are known in the prior art. US-5599309 discloses an auto injector for use with proprietary syringes. That prior art discloses a device comprising a drive member that receives the rear end of a plunger of a syringe and a trigger for releasing the drive member such that a medicament can be injected. Drawbacks with that prior art are that needle is outside the device and visible to the user after the device has been removed from the injection site and that the re-loading is complicated and time consuming.
SUMMARY OF THE INVENTION
It is therefore an object of the invention to provide an injection device with improved user friendliness. In particular, it is an object of the present invention to provide an injection device where the needle is kept non-visible to the user at all times and that the device is easily re-loadable. This object and other objects are solved by an injection device as defined in claim 1 . This object and other objects are also solved by a method as defined in claim 15. Preferred embodiments of the present invention are defined in the dependent claims.
Thus, in accordance with an aspect of the present invention, there is provided a medicament injection device having a proximal end and a distal end and being arranged to receive a replaceable container subassembly having a medicament container with a plunger therein, a needle and a needle shield. The medicament injection device comprises a front housing and a rear housing which are releasably connectable to each other and a reloadable drive mechanism is accommodated in the rear housing for acting on the replaceable container subassembly. The reloadable drive mechanism is moveable between a cocked and an extended position and a release mechanism is provided for releasing the drive mechanism from said cocked position to said extended position. A needle hider front is slidably arranged within the front housing. A needle shield remover is arranged to connect with a needle shield of the replaceable container subassembly received in the reloadable medicament injection device, wherein the needle shield remover is arranged to be removably inserted into a proximal end of the front housing through the needle hider front. The needle shield remover, when inserted into the front housing is adapted to be used to interact with the reloadable drive mechanism accommodated in said rear housing such that a user can relocate the reloadable drive mechanism from said extended position to said cocked position. By designing a needle shield remover and the front housing having a needle hider front such that needle shield remover together with the front housing can be used for reloading the drive mechanism, the use of the device is simplified and improved to a large extent. A user simply has to release the front housing from the rear housing, replace the needle shield remover and then turn the front housing 180 degrees and use the needle shield remover to push the drive mechanism from its proximal, extended position to its distal, cocked position. By providing a needle hider front at the proximal end of the front housing, the needle can be kept out of sight of a user. Many users prefer not to see the needle, neither during use, nor when the device is not used.
In accordance with an embodiment of the medicament injection device according to the invention, a needle hider body is arranged within the front housing and the needle hider front is adjustably connected to the needle hider body by means of a threaded connection. This assures that the needle is kept out of sight at all times.
In accordance with an embodiment of the medicament injection device according to the invention, the needle shield remover and the needle hider front are arranged to mate with each other such that axial movement of the needle shield remover relative to the needle hider front is allowed while rotation of the needle shield remover relative to the needle hider front is prevented. This arrangement allows a user to use the needle shield remover to adjust the axial position of the needle hider front which is connected by a threaded connection to the needle hider body by holding the front housing while turning the needle shield remover.
In accordance with an embodiment of the medicament injection device according to the invention, the needle hider body is axially moveable within the front housing between a proximal end position and a distal end position and wherein a syringe guide is arranged within said needle hider body for receiving a replaceable container subassembly, said syringe guide being axially moveable between a proximal end position and a distal end position relative to the front housing and wherein a proximal end surface of the syringe guide defines a maximum insertion depth for the needle shield remover. The proximal end surface of the syringe guide defines the maximum insertion depth of the needle shield remover and acts as an abutment such that the front housing can be used to relocate the drive mechanism in the rear housing.
In accordance with an embodiment of the medicament injection device according to the invention, a first biasing member is arranged between the syringe guide and the needle hider body. This first biasing member biases the syringe guide towards said distal end position and the needle hider body towards said proximal end position. The first biasing member ensures that the needle hider moves out and covers the needle as soon as the injection device is removed from the injection site such that the needle never will be visible to the patient.
In accordance with an embodiment of the medicament injection device according to the invention, a resilient syringe collar is arranged at a distal end of the syringe guide, said resilient syringe collar being adapted to receive and hold a replaceable container subassembly. The resilient syringe collar, made from e.g. rubber, will make sure that the replaceable container subassembly is firmly held in place while still being replaceable. In accordance with an embodiment of the medicament injection device according to the invention, the front housing comprises internal abutment surfaces defining said proximal end positions and distal end positions for the needle hider body and the syringe guide relative to the front housing. In accordance with an embodiment of the medicament injection device according to the invention, the penetration depth of a needle of a container subassembly received in the reloadable medicament injection device is adjusted by adjusting the position of the needle hider front. The threaded connection of the needle hider front to the needle hider body is a simple solution providing an adjustable penetration depth.
In accordance with an embodiment of the medicament injection device according to the invention, the needle hider front comprises indication means presenting a set needle penetration depth. The indication means can be in the form of numerals visible in a window or opening in the front housing clearly indicating the currently set penetration depth.
In accordance with an embodiment of the medicament injection device according to the invention, the needle shield remover comprises flexible hook means arranged to grasp the needle shield of a replaceable container subassembly received in the reloadable medicament injection device. When the needle shield remover is inserted into the proximal end of the front housing through the needle hider front the flexible hook means will deflect over the outer surface of the needle shield and as soon as the flexible hook means passes the distal end of the needle shield they will flex back to a less biased position and the hook means, preferably provided with a fluke, or barbed element, will securely grasp the needle shield such that when the needle shield remover is pulled out of the front housing, the needle shield will be pulled off the container subassembly received in the medicament injection device.
In accordance with an embodiment of the medicament injection device according to the invention, the reloadable drive mechanism comprises an axially moveable plunger rod driver and a drive spring biasing the plunger rod driver towards the proximal end position. The plunger rod driver and the rear housing comprise corresponding guide means for guiding the plunger rod driver during movement within the rear housing. By providing the drive mechanism and its components in the rear housing, and since the rear and front housings are separable, reloading of the drive mechanism is simplified.
In accordance with an embodiment of the medicament injection device according to the invention, the plunger rod driver is configured to act on the plunger of the replaceable container subassembly for moving axially said replaceable container subassembly in relation to the front housing such that said needle is penetrated and said medicament is expelled through said needle. Obviously, it is understandable that the plunger rod driver is configured to act directly on the plunger when the plunger rod driver may comprise a plunger rod or indirectly through a plunger rod which is part of the container subassembly.
In accordance with an embodiment of the medicament injection device according to the invention, the rear housing comprises a button blocker moveable within the rear housing between a proximal end position, in which the button blocker prevents the release mechanism from releasing the drive mechanism from said cocked position to said extended position, and a distal end position, in which the button blocker allows the release mechanism to release the drive mechanism from said cocked position to said extended position, wherein the button blocker is moved from said proximal end position to said distal end position when the needle hider body is axially moved within the front housing from said proximal end position to said distal end position. This means that the button blocker is released only when the needle hider body is pushed towards a distal end position, e.g. when the medicament injection device is pushed against a patient's skin, which ensures that the medicament injection device is not inadvertently discharged. In accordance with an embodiment of the medicament injection device according to the invention, a second biasing member is provided within the rear housing biasing the button blocker towards said proximal end position. This ensures that as soon as the plunger rod driver is pushed back to its distal end position, the button blocker will assume its proximal end position where release of the drive mechanism is prevented.
In accordance with another aspect of the present invention, there is provided a method for reloading a medicament injection device according to the first aspect of the invention. There, a user removes the front housing from the rear housing having the needle shield remover arranged at the front housing through the needle hider front, and brings the proximal end of the needle shield remover in contact with a proximal end of the reloadable drive mechanism accommodated in said rear housing and subsequently moves the reloadable drive mechanism from said extended position to said cocked position by pushing said front housing and said needle shield remover axially towards said rear housing and said drive mechanism.
BRIEF DESCIRPTION OF THE DRAWINGS
The invention will now be described in more detail and with reference to the appended drawings in which:
Fig. 1 a is a schematic perspective view of an embodiment of the medicament delivery device according to the invention in a disassembled state.
Fig. 1 b is a schematic perspective view of an embodiment of the medicament injection device according to the invention in an assembled state. Fig. 2a is a schematic exploded perspective view of an embodiment of the rear housing of the medicament injection device according to the invention.
Fig. 2b is a schematic exploded perspective view of an embodiment of the rear housing of the medicament injection device according to the invention.
Fig. 3 is a schematic perspective cross-section of an embodiment of the front housing of the medicament injection device according to the invention.
Fig. 4 is a schematic perspective view of an embodiment of the front housing of the medicament injection device according to the invention.
Figs. 5a and 5b is a schematic perspective view of method steps according to the invention.
Fig. 6a, 6b, 7a and 7b are schematic perspective cross-sections of an embodiment of the medicament injection device according to the invention.
DESCRIPTION OF PREFERRED EMBODIMENTS
As used herein, the term "container" encompasses all types of containers suitable for injectable liquid composition. Concerning the terms "distal" and "proximal" they refer to points which are further away and closer to the injection site respectively.
In a first embodiment of a medicament delivery device 100 according to the invention, as shown in figures 1 a and 1 b, a medicament injection device 100 comprises a rear housing 101 made from e.g. thermoplastic, a front housing 102 and a replaceable container subassembly 103, such as a syringe. The rear and front housings 101 , 102 are connectable to each other by e.g. a twisting coupling. Typically, the front and rear housings 101 , 102 can be connected and disconnected by a 90 degree relative twist of the housings 101 , 102. The replaceable container subassembly 103 may comprise a needle (not shown in figure 1 a), a medicament container 15, a plunger 14, a plunger rod 13 and a needle shield 1 1 arranged to protect users from the needle. Obviously, it is also imaginable that the container subassembly 103 lacks a plunger rod 13 and that this plunger rod is part of the device.
Figures 2a and 2b disclose the rear housing 101 comprising the drive mechanism 108. The drive mechanism 108 comprises a plunger rod driver 1 arranged axially moveable within the rear housing 101 between a proximal end position (shown in figure 2a) and a distal end position (shown in figure 2b). The proximal end position of the plunger rod driver 1 corresponds to a position where the plunger rod 13 and the plunger 14 of the replaceable container subassembly 103 have been pressed to the end of its stroke, i.e. the medicament container 15 has been emptied, and the distal end position of the plunger rod driver 1 corresponds to a position where the plunger rod 13 and the plunger 14 of the replaceable container subassembly 103 have not yet been moved, i.e. the medicament container 15 is full. The drive
mechanism 108 further comprises a drive spring 2, here in the form of a helical coil spring, which biases the plunger rod driver 1 towards its proximal end position. A release mechanism 3 for releasing the plunger rod driver 1 of the drive mechanism 108 from the distal, or cocked, position to the proximal, or extended, position is arranged at an upper surface of the rear housing 101 . The release mechanism 3 is pivotable around a pivoting axle 6 between an extended position (shown in figure 2b) and a depressed position (shown in figure 2a) and comprises a trigger button 4 and an abutment member 5 which abuts and interworks with the plunger rod driver 1 . In figure 2a, the release mechanism 3 has been depressed and the plunger rod driver 1 has adopted its extended, proximal end position. In this position the abutment member 5 abuts an upper surface of the plunger rod driver 1 and prevents the release mechanism 3 from pivoting back around pivot axle 6. The design of the details imply that as long as the plunger rod driver 1 is not in its distal end position, the release mechanism 3 cannot assume its extended position but is instead locked in the depressed position. A resilient member (not shown in the figures) is provided biasing the trigger button 4 towards its extended position which means that when the interaction between the plunger rod driver 1 and the release mechanism 3 allow for it, i.e. when the abutment member 5 of the release mechanism 3 reaches recess 9 in the plunger rod driver 1 , the release mechanism 3 will assume its extended position (see figure 2b). Adjacent, or at least near, the release mechanism 3 a status window 7 is arranged through which symbols provided on the plunger rod driver 1 are visible to indicate the status of the medicament delivery device 100. The status window is preferably made of a transparent, or at least translucent, plastic material. The rear housing 101 can be made up of two halves which are secured to each other by means of pins or projections 8 provided at one of the halves and corresponding openings 8' (not shown in figures 2a or 2b) in the other halves. Obviously, other solutions are
imaginable, such as tongue and groove solutions; snap catch elements; or even permanent securing with welding or gluing. Interacting guide means 10 are provided on an outer surface of the plunger rod driver 1 and an internal surface of the rear housing 101 guiding the plunger rod driver 1 during its movement within the rear housing 101 .
Figure 3 shows a cross-section of a front housing 102 provided with a replaceable container subassembly in the form of a syringe 103 and a needle shield remover 109 partially arranged at a proximal end of the front housing 102 and grasping a needle shield 1 1 encompassing a needle 12 of syringe 103. The syringe 103 further comprises a plunger rod 13, a plunger 14 and a medicament container 15. A needle hider front 16 is provided at a proximal end of the front housing connected to a needle hider body 17 by means of a threaded connection 18, more specifically the needle hider front 16 is provided on the needle hider body 17. The needle shield remover 109 comprises a proximal and a distal end, wherein the distal end is arranged at the proximal end of the front housing 102 through the needle hider front 16. The threaded connection 18 provides a user with a possibility of adjusting the penetration depth of needle 12 during use. The needle hider body 17 extends through the inside of the front housing 102 and encompasses the syringe 103. The purpose of the needle hider body 17 and the needle hider front is to hide the needle from a user, both during and between uses of the device. The needle hider body 17 and front housing 102 are provided with corresponding abutment surfaces 20, 21 which define the distal and proximal end positions of the axial movement of needle hider body 17 relative to the front housing 102. This relative axial movement in combination with the adjustability of the needle hider front 16 ensures that the needle 12 is kept non-visible at all time. A syringe guide 24 is arranged within front housing 102, more specifically within the needle hider body 17, axially moveable between a distal end position and a proximal end position relative to the front housing 102. The proximal end position is defined by corresponding abutment surfaces (not shown) provided on an internal surface of the front housing 102 and on the external surface of the syringe guide 24 respectively. The abutment surfaces provided on the front housing 102 and on the syringe guide 24 will typically have to extend through openings or slots provided in the needle hider body 17 in order to connect with each other. These abutment surfaces in
combination with the adjustable needle hider front 16 determine the
penetration depth of needle 12 during use of the device. The needle shield remover 109 is configured to be partially inserted i.e. axially movable into the proximal end of the front housing 102 through the needle hider front 16 and through the needle hider body 17. The axial movement of the needle shield remover when inserted into the proximal end of the front housing 102 is stopped by the interaction between the abutment surfaces of the syringe guide 24 and of the needle shield remover 109, more specifically the proximal end of the syringe guide and the distal end of the needle shield remover 109, while the abutment surfaces between the front housing 102 and the syringe guide 24 serve to prevent the syringe guide from moving distally relative to the front housing 102. A resilient syringe collar 25, typically made of rubber, is arranged at a distal end of the syringe guide 24 for receiving and holding the syringe 103. The resilient material will securely hold the syringe in place while still allowing it to be replaced after it has been emptied. Normally, the resilient syringe collar 25 will stay in its position in the syringe guide during
replacement of the syringe but can of course be exchanged if necessary. A first biasing member 19 is arranged between the syringe guide 24 and the needle hider body 17 which biases the syringe guide 24 towards its distal end position and the needle hider body 17 towards its proximal end position. The first biasing member 19 ensures that as soon as the device according to the invention is removed from the injection site, the needle hider body, and thus also the needle hider front 16, automatically travel outwards keeping the needle 12 out of sight to a user. The front housing 102 can be made up of two halves which are secured to each other by means of pins or projections 8 (not shown in figure 3) provided at one of the halves and corresponding openings 8' in the other halves. Obviously, other solutions are imaginable, such as tongue and groove solutions; snap catch elements; or even permanent securing by welding or gluing.
In figure 4 the easiness of adjusting the penetration depth of needle 12 is displayed. Needle shield remover 109 is provided with axially running protrusions 23 having a corresponding shape to recesses 22 provided in the needle hider front 16. This means that the needle shield remover 108 can be inserted axially into needle hider front 16 while any relative rotational movement between the two is prevented. By using the needle shield remover 109 as a grip element, a user can adjust the position of the needle hider front 16 relative to the needle hider body 17 by turning, thus setting the penetration depth of the needle 12 during use. The front housing 102 and/or the needle hider body 17 may be provided with means defining a number of pre-set positions which snap in place when the needle hider front 16 is turned. The needle hider front 16 is provided with digits 26 visible in a cut-out, window 29 or similar provided at the front housing 102 indicating a set penetration depth. The penetration depth can be adjusted back and forth until a desired value has been set.
Figures 5a and 5b schematically show how the drive mechanism of the device 100 is reloaded. The front housing 102 having the needle shield remover 109 attached at its front end through the needle hider front 16 is removed from the rear housing 101 by twisting the housings 90 degrees relative to each other. Then, the proximal end of the needle shield remover 109, is positioned abutting the drive mechanism 108 arranged in the rear housing 101 and situated in its proximal end position. Thereafter, the front housing together with the needle shield remover 109 is used to force the drive mechanism 108 towards its proximal end position where it will snap into a cocked position, ready to be used. A more detailed explanation of the functioning of the device will be provided with respect to figures 6a, 6b, 7a and 7b below.
Figure 6a shows the device loaded with a fresh syringe and in a cocked position, i.e. drive spring 2 is completely compressed such that the drive mechanism 108 is loaded but release mechanism 3 is prevented from releasing the plunger rod driver 1 . This is realized by the button blocker 26 reaching from a proximal part of the rear housing 101 to a distal part of the rear housing 101 where it prevents the trigger button 4 from being depressed and releasing the drive mechanism 108. In the embodiment shown in figures 6-7, the button blocker 26 is moveable between a proximal and a distal position defined by the openings 8' provided in the rear housing 101 .
Abutment member 5 of the release mechanism 3 (see also figures 2a and 2b) reaches into recess 9 of the plunger rod driver 1 and prevents it from moving forward towards its proximal end position. The needle shield remover 109 is still in place grasping needle shield 1 1 and it can be used to set a desirable penetration depth. In figure 6b the needle hider front has been set in a position corresponding to maximum penetration depth and the needle shield remover 109 has subsequently been pulled out together with the needle shield 1 1 . The device 100 is now in position corresponding to when a user presses it against the intended injection site by which the needle hider body 17 and needle hider front 16, have assumed the distal end position, where abutment surfaces 20, 21 come in contact with each other. Upon pressing the device against the injection site, the needle hider body 17 also comes into contact with the button blocker 26. As the needle hider body 17 travels backwards, towards the distal end position, it forces the button blocker 26 axially relative to the rear housing towards a distal end position. This movement of the button blocker 26 allows the release mechanism 3 to be activated and the device 100 is now ready to start the injection. In figure 7a the trigger button 4 has been depressed, causing the plunger rod driver 1 to be forced forwards by drive spring 2 and thereby moving the syringe 103 and syringe guide 24 towards the proximal end position of the syringe guide 24. As the syringe 103 and syringe guide 24 move forward, needle 12 penetrates the injection site and the plunger rod 13 forces the plunger 14 forward thus emptying the content of the syringe through the opening in the needle. The force of the drive spring 2 is far more powerful than that of the first biasing member 19 which therefore is compressed when the drive mechanism 108 is released. Figure 7b corresponds to a state where a user has removed the device from the injection site after completed injection. As soon as this is done, the first biasing member 19 extends and needle hider body 17 assumes its proximal end position thus effectively hiding the needle 12 from being visible to a user. A second biasing member 27 is provided between the rear housing 101 and the button blocker 26 which, when the drive mechanism 108 is forced to its distal end position and the release mechanism assumes its extended position (see description referring to figures 2a and 2b), will force the button blocker 26 to assume its proximal end position thus preventing the trigger button 4 from being depressed. Also shown in e.g. figure 6a is a spring guide 28 which supports and guides drive spring 2 in order to avoid buckling of drive spring 2 during compression. Finally, it is realized, that a medicament injection device according to the invention has a number of advantages over the known prior art devices. Due to the fact that the device has a completely mechanical design, reliability can be ensured at all time without being dependent on batteries or similar. The drive mechanism can in a simple and reliable manner be reloaded by using the front housing and the needle shield remover of the device itself. The needle hider front is biased and always covers the needle such that the needle never will be visible to the patient. Penetration depth can also be set in a very simple and user-friendly manner. By using the needle shield remover as a grip, also users with reduced strength and/or co-ordination will be able to do this. The indication means of the present invention will in a clear and concise manner present a set penetration depth. The set penetration depth will not have to be re-set for each injection occasion; instead the device according to the present invention provides an automatic penetration depth memory. The device is re-usable and the user can change the emptied syringe to a new in a simple manner. The device allows for a variable penetration depth and the setting of the dose can be set downwardly and upwardly until a required depth has been set.
It is to be understood that the embodiments described above and in the drawings are to be regarded only as non-limiting examples of the invention and that they may be modified in many ways within the scope of the claims.

Claims

Claims
1 ) A medicament injection device (100) arranged to receive a replaceable container subassembly (103) having a medicament container (15) with a plunger (14) therein, a needle (12) and a needle shield (1 1 ), wherein said medicament injection device (100) has a proximal end and a distal end and wherein said medicament injection (100) device comprises:
- a front housing (102) and a rear housing (101 ) releasably
connectable to each other,
- a reloadable drive mechanism (108) accommodated in said rear housing (101 ) for acting on the replaceable container subassembly (103), said reloadable drive mechanism (108) being moveable between a cocked and an extended position;
- a release mechanism (3) for releasing the drive mechanism (108) from said cocked position to said extended position;
- needle hider front (16) slidably arranged within the front housing (102); and
- a needle shield remover (109) arranged to connect with the needle shield (1 1 ) of the replaceable container subassembly (103) received in the reloadable medicament injection device (100), wherein said needle shield remover (109) is arranged to be removably inserted into a proximal end of the front housing (102) through the needle hider front (16);
- the needle shield remover (109), when inserted into the front
housing (102) is adapted to be used to interact with the reloadable drive mechanism (108) accommodated in said rear housing (101 ) such that a user can re-locate the reloadable drive mechanism (108) from said extended position to said cocked position;
- a needle hider body (17) is arranged within the front housing (102) and wherein the needle hider front (16) is adjustably connected to the needle hider body by (17) means of a threaded connection (18);
- wherein the needle shield remover (109) and the needle hider front (16) are arranged to mate with each other such that axial movement of the needle shield remover (109) relative to the needle hider front (16) is allowed while rotation of the needle shield remover (109) relative to the needle hider front (16) is prevented.
2) A medicament injection device (100) according to claim 1 wherein the needle hider body (17) is axially moveable within the front housing (102) between a proximal end position and a distal end position and wherein a syringe guide (24) is arranged within said needle hider body (17) for receiving a replaceable container subassembly (103), said syringe guide (24) being axially moveable between a proximal end position and a distal end position relative to the front housing (102) and wherein a proximal end surface of the syringe guide (24) defines a maximum insertion depth for the needle shield remover.
3) A medicament injection device (100) according to claim 2 wherein a first biasing member (19) is arranged between the syringe guide (24) and the needle hider body (17) and wherein said first biasing member (19) biases the syringe guide (24) towards said distal end position and the needle hider body (17) towards said proximal end position. 4) A medicament injection device (100) according to claim 2 wherein a
resilient syringe collar (25) is arranged at a distal end of the syringe guide (24), said resilient syringe collar (25) being adapted to receive and hold a replaceable container subassembly (103). 5) A medicament injection device (100) according to claim 2 wherein the front housing (102) comprises internal abutment surfaces defining said proximal end positions and distal end positions for the needle hider body (17) and the syringe guide (24) relative to the front housing (102).
6) A medicament injection device (100) according to claim 1 wherein the penetration depth of a needle (12) of a container subassembly (103) received in the reloadable medicament injection device (100) is adjusted by adjusting the position of the needle hider front (16).
7) A medicament injection device (100) according to claim 1 wherein the needle hider front (16) comprises indication means (26) presenting a set needle penetration depth.
8) A medicament injection device (100) according to claim 1 wherein the needle shield remover (109) comprises flexible hook means arranged to grasp the needle shield (1 1 ) of a replaceable container subassembly (103) received in the reloadable medicament injection device (100).
9) A medicament injection device (100) according to claim 1 , wherein the reloadable drive mechanism (108) comprises an axially moveable plunger rod driver (1 ), a drive spring (2) biasing the plunger rod driver (1 ) towards a proximal end position and wherein the plunger rod driver (1 ) and the rear housing (101 ) comprise corresponding guide means (10) for guiding the plunger rod driver (1 ) during movement within the rear housing (101 ).
10) A medicament injection device (100) according to claim 8, wherein the plunger rod driver (1 ) is configured to act on the plunger (14) of the replaceable container subassembly (103) for moving axially said replaceable container subassembly (103) in relation to the front housing (102) such that said needle is penetrated and said medicament is expelled through said needle.
1 1 ) A medicament injection device (100) according to claim 2 wherein the rear housing (101 ) comprises a button blocker (26) moveable within the rear housing (101 ) between a proximal end position, in which the button blocker (26) prevents the release mechanism (3) from releasing the drive mechanism (108) from said cocked position to said extended position, and a distal end position, in which the button blocker (26) allows the release mechanism (3) to release the drive mechanism (108) from said cocked position to said extended position, wherein the button blocker (26) is moved from said proximal end position to said distal end position when the needle hider body (17) is axially moved within the front housing (102) from said proximal end position to said distal end position.
12) A medicament injection device (100) according to claim 1 1 wherein a second biasing member (27) is provided within the rear housing (101 ) biasing the button blocker (26) towards said proximal end position.
13) A method for reloading a medicament injection device (100) according to any of claims 1 -12, wherein a user removes the front housing (102) from the rear housing (101 ) having the needle shield remover (109) arranged at the front housing (102) through the needle hider front (16), and brings the proximal end of the needle shield remover (109) in contact with a proximal end of the reloadable drive mechanism (108) accommodated in said rear housing (101 ) and subsequently moves the reloadable drive mechanism (108) from said extended position to said cocked position by pushing said front housing (102) and said needle shield remover (109) axially towards said rear housing and said drive mechanism.
PCT/EP2013/066542 2012-08-20 2013-08-07 Automatic injection device WO2014029621A1 (en)

Priority Applications (12)

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AU2013305182A AU2013305182B2 (en) 2012-08-20 2013-08-07 Automatic injection device
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JP2015527845A JP6510408B2 (en) 2012-08-20 2013-08-07 Automatic injection device
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US14/422,474 US10052436B2 (en) 2012-08-20 2013-08-07 Automatic injection device
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ZA2015/01128A ZA201501128B (en) 2012-08-20 2015-02-18 Automatic injection device
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AU2013305182B2 (en) 2017-01-12
EP2885026A1 (en) 2015-06-24

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