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WO2025114261A1 - Dispositif d'administration de médicament à ressort d'entraînement - Google Patents

Dispositif d'administration de médicament à ressort d'entraînement Download PDF

Info

Publication number
WO2025114261A1
WO2025114261A1 PCT/EP2024/083576 EP2024083576W WO2025114261A1 WO 2025114261 A1 WO2025114261 A1 WO 2025114261A1 EP 2024083576 W EP2024083576 W EP 2024083576W WO 2025114261 A1 WO2025114261 A1 WO 2025114261A1
Authority
WO
WIPO (PCT)
Prior art keywords
spring
housing
distal
drive spring
helical drive
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/EP2024/083576
Other languages
English (en)
Inventor
Bjørn Gullak LARSEN
Mikkel Oliver Bruun-Jespersen
Bennie Peder Smiszek Pedersen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novo Nordisk AS
Original Assignee
Novo Nordisk AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk AS filed Critical Novo Nordisk AS
Publication of WO2025114261A1 publication Critical patent/WO2025114261A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
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    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A—HUMAN NECESSITIES
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    • 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
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
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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
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A—HUMAN NECESSITIES
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    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/3159—Dose expelling manners
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    • 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
    • A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
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    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
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    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
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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
    • A61M5/3276—Means imparting rotational movement to the needle or needle hub in order to assist in its disconnection from syringe nozzle
    • 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
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    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/348—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub snap lock, i.e. upon axial displacement of needle assembly
    • 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
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M2005/3208—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles by application of rotational movement to the needle hub, e.g. by use of electrically driven toothed wheels
    • 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
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • A—HUMAN NECESSITIES
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    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8281—Mechanical spring operated
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

Definitions

  • the present invention generally relates to a drug delivery device intended for subcutaneous introduction of a fluid drug formulation, the device comprising a drive spring adapted to expel one or more dose volumes of the fluid drug formulation.
  • the dose volumes may be predetermined or set by a user.
  • Spring driven drug delivery devices for so-called “automatic” injection of dose volumes of a liquid drug are well known in the art. Some of these drug delivery devices use a compression spring for driving out the dose volume and other use a torsion spring.
  • Such drug delivery devices are consequently provided with a dose setting mechanism by which the user incrementally can select the size of the dose volume to be injected, e.g. as disclosed in US 6,899,699.
  • the dose expelling in US 6,899,699 is automatic and driven by a spring which can either be a compression spring or a torsion spring.
  • WO 2014/161952 and US 2013/0281943 disclose examples of drug delivery devices comprising a dose setting mechanism and a torsion drive spring.
  • US 2019/0328969 discloses a further example of an adjustable spring-driven drug delivery device comprising a drive spring having respective ends rotationally locked to the housing respectively the number sleeve, the drive spring comprising a central portion with axially spaced apart coil portions.
  • liquid drugs e.g. GLP-1 type of drugs
  • a treatment regimen for a given patient in which the same dose volume is injected for each injection.
  • the drive spring may be strained by the user prior to use, or the device may be delivered to the patient with a pre-strained drive spring, e.g. as disclosed in WO 2021/ 122200.
  • An alternative to using a plurality of such single-use fixed dose devices is to use a drug delivery device adapted to expel a plurality of predetermined and equally sized dose volumes.
  • Such drug delivery devices are sometimes referred to as multi-use fixed dose drug delivery devices.
  • Examples of such multi-use fixed dose device for expelling a plurality of predetermined and equally sized dose volumes are disclosed in WO 2017/098460, WO 2018/007259 and in WO 2020/089167, the devices comprising a drive spring which is strained by the user prior to expelling a pre-set dose of drug.
  • US 2022/0409820 discloses a multi-use fixed dose drug delivery device comprising a drive spring which come pre-strained for the plurality of doses, the drive spring comprising an open section allowing the spring to accommodate axial movement between the proximal and distal anchoring points of the spring.
  • the drive spring has to be arranged and coupled to the device in a way allowing it to function properly during both assembly and subsequent operation.
  • a drug delivery device comprising a torsion drive spring which can be manufactured cost-effectively, and which assures a high degree of operational reliability during subsequent operation.
  • the drug delivery device may be of the fixed dose type or the user-settable dose type.
  • Such a drug delivery device may be adapted to expel a single or a plurality of fixed doses or it may allow the user to set a desirable dose amount to be expelled. It may be provided with a factory pre-strained drive spring, or the user may strain the spring for one or more doses prior to use or during dose setting.
  • a drug delivery device comprising or adapted to receive a drug-filled cartridge.
  • the drug delivery device comprises a housing, a spring base coupled to the housing, and an expelling assembly.
  • the expelling assembly comprises a piston rod adapted to engage and axially displace a piston in a loaded cartridge in a distal direction when rotated to thereby expel a dose of drug from the cartridge, a drive member adapted to rotate, directly or indirectly, the piston rod, and a helical drive spring having a distal end coupled to the drive member and a proximal end coupled to the spring base, the helical drive spring defining a reference axis.
  • the expelling assembly further comprises control means adapted to control the amount of rotation of the drive member and thereby the amount of drug expelled, and actuatable release means adapted to release the control means to allow the helical drive spring to rotate the drive member to thereby expel a dose amount.
  • the helical drive spring proximal end comprises a hook-formed portion arranged in a transversal plane relative to the reference axis, and the spring base comprises an axially oriented free edge adapted to engage the hook-formed portion, this allowing the hook-formed portion and the free edge to slide axially relative to each other.
  • the free edge easily can catch the helical drive spring proximal hook-formed portion when the spring base is rotated.
  • the helical drive spring can freely expand and contract lengthwise when the spring is strained during manufacturing and de-strained during out-dosing, respectively, any length variation being accommodated by the sliding engagement between the spring proximal end and the spring base free edge.
  • the spring base is moveable between (i) a proximal position relative to the housing in which the free edge is in engagement with the hook-formed portion, the spring base being rotatable relative to the housing allowing the spring to be strained, and (ii) a distal position in which the free edge is in engagement with the hook-formed portion, the spring base being rotationally locked to the housing, wherein the hook-formed portion is in sliding engagement with the free edge when the spring base is moved from the proximal to the distal position.
  • the spring base can be moved to a second axial position with exerting an axial force on the spring.
  • the spring base may be non-movable locked to the housing when moved into the distal position.
  • the spring base may be axially moveable from the distal to the proximal position, this allowing a user to re-strain the helical drive spring, e.g. for use in a non-disposable device.
  • the helical drive spring is a non-compressible helical spring, i.e. with closed windings along its length, such a spring being axially more compact just as the tendency to tangle with other springs during handling is reduced.
  • the drive member may comprise a tubular portion adapted to receive the helical drive spring.
  • the tubular portion may comprise a spring holder structure adapted to radially engage an unstrained helical drive spring when the helical drive spring is mounted in the tubular portion to thereby limit axial movement of the helical drive spring during assembling of the drug delivery device.
  • a method of assembling a drug delivery device or a component therefor comprising the steps of (i) providing a helical drive spring comprising a distal coupling structure and a proximal coupling structure, the helical drive spring defining a reference axis, the proximal coupling structure comprising a hook-formed portion arranged in a transversal plane, (ii) providing a drive member comprising a tubular portion adapted to receive the helical drive spring, the tubular portion comprising at the distal end a coupling structure adapted to engage and hold the helical drive spring distal coupling structure, (iii) providing a tubular housing adapted to receive the drive member, and (iv) providing a spring base adapted to be received in the housing in a proximal and relative to the housing rotatable free position, the spring base being moveable to a distal rotationally locked position relative to the housing, the spring base comprising an axially extending
  • the method comprising the further steps of (v) inserting the drive member in the housing, (vi) inserting the helical drive spring in the drive member tubular portion, (vii) inserting the spring base in the housing in the proximal position, (viii) rotating the spring base relative to the housing until the free edge engages the helical drive spring hook-formed portion, (ix) further rotating the spring base relative to the housing until the helical drive spring has been strained to above a pre-determined amount, and (x) moving the spring base from the proximal to the distal position, the helical drive spring hook- formed portion thereby sliding axially on the free edge.
  • the helical drive spring distal coupling structure engages the drive member coupling structure during either insertion of the helical drive spring in the drive member tubular portion or during initial rotation of the helical drive spring, thereby allowing the helical drive spring to be strained.
  • the “sliding edge” design allows for efficient and cost-effective manufacturing.
  • the drive member coupling structure comprises an opening adapted to axially receive and engage the helical drive spring distal coupling structure during insertion of the helical drive spring in the drive member tubular portion.
  • the drive member coupling structure may comprise a catch adapted to rotationally receive and engage the helical drive spring distal coupling structure during initial rotation of the helical drive spring.
  • the spring base may be move from the distal to the proximal position, this allowing rotating the spring base relative to the housing to re-strain the helical drive spring, e.g. for a non-disposable device.
  • drug is meant to encompass any drug-containing flowable medicine capable of being passed through a delivery means such as a hypodermic needle in a controlled manner, such as a liquid, solution, gel or fine suspension.
  • the drug may have a blood glucose controlling effect, e.g. human insulin and analogues thereof as well as non-insulins such as GLP-1 and analogues thereof.
  • Fig. 1 shows a drug delivery device with a mounted needle unit
  • fig. 2 shows in a cross-sectional view the drug delivery device 1 with the needle unit being replaced with a cap
  • fig. 3 shows an exploded view of the components of the drug delivery assembly of figs. 1 and
  • figs. 4A and 4B show a perspective respectively a cross-sectional view of the cartridge holder of fig.
  • figs. 5A and 5B show a perspective respectively a cross-sectional view of the drive nut of fig.
  • figs. 6A-6C show a perspective respectively cross-sectional views of the housing member of fig. 3
  • figs. 6D and 6E show in cut-away views details of the structures surrounding the housing tower
  • figs. 7A and 7B show a perspective respectively a cross-sectional view of the actuator of fig. 3
  • fig. 8 shows a perspective view of the return spring of fig. 3
  • figs. 9A and 9B show a perspective respectively a cross-sectional view of the control member of fig.
  • figs. 10A and 10B show a perspective respectively a cross-sectional view of the drive member of fig. 3
  • fig. 11 shows a perspective view of the piston rod of fig. 3, fig.
  • figs. 13A and 13B show a perspective respectively a cross-sectional view of the spring base member of fig. 3
  • fig. 14 shows in cross-section the drug delivery device of fig. 2, the cap, the cartridge, the cartridge holder and the return spring being removed for better visibility
  • fig. 15 shows a detail proximal cross-sectional view of the drive spring arranged in the spring base
  • fig. 16 shows a detail distal cross-sectional view of the drive spring arranged in the spring base
  • fig. 17 shows a detail cross-sectional view of an actuator drop lock flexible finger in engagement with a housing drop lock stop surface, figs.
  • FIGS. 18A-18F show in a series of perspective views movement of the actuator knob and control member relative to the housing tower portion during expelling of a dose of drug
  • figs. 19A and 19B show a perspective respectively a cross-sectional view of the shield member of fig. 3
  • figs. 20A and 20B show a perspective respectively a cross-sectional view of the hub member of fig. 3
  • figs. 21 A and 21 B show a perspective respectively a cross-sectional view of a container for the needle unit of fig. 1
  • fig. 22 shows a cross-sectional view of the needle unit of fig. 1 arranged in the container of fig. 21A, figs.
  • 23A-23J show in a series of cross-sectional views mounting, actuation and removal of the needle unit on the drug delivery device
  • figs. 23CX and 23GX show cut-away views of the corresponding figs. 23C and 23G
  • figs. 24A-24C show in a series of cut-away perspective views movement of the shield and needle hub relative to a housing indicator opening during actuation of the needle unit.
  • distal refers to a portion of an element, assembly or device which during use is oriented towards a skin surface of a user
  • proximal refers to the opposed portion.
  • the needle is arranged at the distal end and an end-mounted release button is arranged at the proximal end.
  • the term member or element when used for a given component, it generally indicates that in the described embodiment the component is a unitary component, however, the same member or element may alternatively comprise a number of sub-components just as two or more of the described components could be provided as unitary components, e.g. manufactured as a single injection moulded part.
  • the term “assembly” does not imply that the described components necessarily can be assembled to provide a unitary or functional assembly during a given assembly procedure but is merely used to describe components grouped together as being functionally more closely related.
  • a drug delivery device 1 with a mounted needle unit 2 is shown.
  • the device has a general tubular configuration defining a general reference axis.
  • Fig. 2 shows in a cross-sectional view the drug delivery device 1 with the needle unit being replaced with a cap.
  • the cap fits snugly over the distal part of the drug delivery device and thus does allow a needle unit to be mounted at the same time.
  • the drug delivery device comprises a distal cartridge holder portion 3 in which a drug filled cartridge is arranged, a proximal portion comprising a drive spring system 4 as well as an intermediate portion comprising a control system 5.
  • a piston rod is arranged axially in the device and adapted to be moved distally by the drive spring to expel an amount of fluid drug through a mounted needle unit, the amount of axial travel of the piston rod being controlled by the control system.
  • the actuator return spring is not shown.
  • the drug delivery device comprises a tubular housing 400 with a proximal engine portion 401 and a distal cartridge portion 402 adapted to house a cartridge holder 300 in which a drug cartridge 390 is arranged, the drug cartridge comprising a distal outlet end with a needle pierceable septum, a proximal circumferential edge 391 and an axially displaceable piston 392 (see fig. 17).
  • a piston washer 395 is arranged in the cartridge engaging the piston proximal surface.
  • An actuator 500 comprises a cylindrical proximal portion 501 from which a pair of legs 502 extend distally interposed between the housing and the cartridge holder.
  • the drive nut 600 is mounted in the housing and adapted to receive piston rod 650 in threaded engagement.
  • the piston rod is non-rotationally received in the distal tubular portion 802 of drive member 800 which is adapted to be rotationally driven by pre-strained drive spring 890 arranged in the proximal portion 801 of the drive member, the drive spring’s proximal end being anchored to the housing via spring base 900.
  • Control member 700 is in splined engagement with the drive member tubular portion 802 and is adapted to be moved axially in and out of engagement with the housing to thereby control rotation of the drive member.
  • a large-diameter return spring 590 is arranged to provide a distally directed biasing force on the actuator.
  • the drug delivery device is adapted to receive a needle unit at its distal end, the needle unit comprising a needle hub 100 with a needle 101 , the needle hub being arranged in a shield member 200.
  • a needle unit is not mounted on the drug delivery device a cap 490 can be mounted to cover the cartridge portion 402.
  • the needle unit will be described after the drug delivery device.
  • the cartridge holder 300 has a generally cylindrical configuration with a larger proximal opening 301 allowing a cartridge to be inserted and a smaller distal opening allowing a hollow needle to be inserted through a septum of a mounted cartridge.
  • the distal end comprises a needle unit mount in the form of cartridge mount 310 with a pair of opposed part-circumferential flange portions 311 adapted to receive a pair of flexible needle hub coupling arms (see below). Neighbouring the flange portions are portions 312 with lower and/or less inclined release flanges allowing the hub coupling arms to disengage with ease.
  • the cylindrical main portion comprises a pair of opposed longitudinal openings 315 allowing a user to inspect the content of the cartridge as well as the position of the cartridge piston.
  • Each opening is surrounded by a radially extending window wall 316 adapted to engage with a corresponding window 416 in the housing 400, the wall comprising a number of indicator lines 317 arranged to align with the cartridge piston to thereby indicate to the user the number of remaining doses.
  • indicator bridges could span the window.
  • the cartridge proximal end comprises a pair of opposed circumferentially extending flexible support arms 320 each having a free end portion with a protrusion 321 extending radially into the opening 301 , the flexibility of the arm allowing the protrusion to be moved radially out of the opening to allow insertion of a cartridge.
  • a free space 322 is provided distally of the flexible support arm allowing the support arm to be deformed into the free space when engaging the housing pressure edges 437 during assembling to thereby eliminate axial play of a mounted cartridge (see below).
  • the flexible arms together with the neighbouring parts of the cartridge holder form a cartridge holder proximal edge 323 with gaps corresponding to the flexible arm free ends.
  • the edge is arranged generally in a transversal plane.
  • the drive nut 600 comprises a generally tubular main portion 610 with an interior thread 611 adapted to engage a corresponding thread on the piston rod 650.
  • the drive nut comprises a first pair of opposed distally oriented flexible mounting fingers 620 adapted to be received in corresponding nut slots in the housing central portion. Each finger is provided with a small flexible finger 621 allowing the drive nut to snap into engagement with the housing - at this stage with a small axial play.
  • the fingers are oriented slightly outwards to secure proper contact with the nut slots during subsequent fixation of the drive nut in the housing, e.g. by application of laser energy through an opening in the housing (see below).
  • the drive nut further comprises a second pair of opposed circumferentially extending flexible fingers 630 each being inclined in the proximal direction to provide a distally directed biasing force during assembling.
  • the generally tubular housing 400 comprises a proximal engine portion 401 , a distal cartridge portion 402 and a generally cylindrical tower portion 430 arranged distally in the engine portion.
  • the tower distal portion is connected to the outer housing via a pair of opposed bridge portions 440 forming a pair of openings therebetween providing axial passageways for the actuator legs 502 (see below) between the cartridge and engine portions.
  • Each bridge portion 440 is provided with a proximally extending lock rib 447 adapted to engage the actuator triangular index positions (see below).
  • a neighbouring proximally facing rib 448 serves as an axial support for the actuator.
  • the cartridge portion 402 comprises a distal indicator opening 405, a pair of opposed windows 410, and a distal pair of opposed shield slots 415 adapted to receive corresponding shield mounting ribs 245 (see below).
  • Proximally on the inner surface a pair of opposed inwardly protruding and distally facing drop lock stop surfaces 407 are provided, as well as a pair of opposed proximally extending point-of-no-return (PONR) flexible arms 408 with a proximally facing PONR stop surface 409 (see fig. 6D).
  • PONR point-of-no-return
  • the engine portion 401 comprises a distal pair of opposed nut openings 406 allowing access to the drive nut mounting points during assembly, e.g. allowing the drive nut to be fixed to the housing using a laser beam, as well as a proximal pair of opposed flexible snap lock fingers 420 allowing the spring base 900 to be mounted fixedly in the housing and thus form part of the housing, the snap lock fingers each comprising an inwardly protruding snap hook 421 .
  • a number of inner axial ribs 404 provide radial support for the actuator 500 and actuator return spring 590.
  • the tower comprises a pair of opposed axially oriented inner nut slots 432 adapted to receive the drive nut mounting fingers 620.
  • the distal edge of the tower forms a pair of opposed part-circumferential support flanges 431 adapted to be received in the cartridge holder proximal opening 301 .
  • Each support flange is associated with a radially extending pressure edge 437 (see fig. 6E) adapted to engage and deform the cartridge holder flexible arm when the cartridge holder is inserted in the housing (see below).
  • the tower further comprises a proximally oriented helical control surface 433, the ends of the helical surface being connected with an axially oriented stop edge (or stop surface) 434 which extends distally to create a notch 435 in the helical surface.
  • an inner circumferential stop flange 438 is provided adapted to engage the drive member 800.
  • a stop knob 439 is located proximally of the stop flange serving as a second rotational stop for the control member.
  • a single indicator opening 405 is provided but alternatively a second opposed opening could be provided.
  • the actuator 500 comprises a cylindrical proximal portion 501 from which a pair of legs 502 extend distally.
  • the cylinder portion comprises a distal outer circumferential spring support flange 510 adapted to engage return spring 590, as well as an inner actuator knob 516 and drop lock flange 511 , the latter providing an axial stop for the control member helical flange 710 (see below) and thus serves as a drop lock for the control member 700.
  • the cylinder portion distal edge is provided with a pair of serrated clutch portions 517 each creating two triangular index positions adapted to engage the housing lock ribs 447 in an initial respectively in an actuated rotational position, thereby providing an anti-rotational clutch when engaged.
  • Each actuator leg 501 comprises a proximal outwardly protruding flexible drop lock finger 520 with a proximally facing drop lock surface 521 at the proximal free end adapted to engage a housing drop lock stop surface 407.
  • Each actuator leg 501 further comprises a proximal axially oriented PONR wedge structure 530 with a distally facing stop surface 531 adapted to engage a PONR proximally facing housing stop surface 409.
  • each actuator leg comprises a distal-most actuation surface 523 adapted to engage the needle shield 200 as well as a neighbouring inclined release surface 524 adapted to engage the needle hub 100.
  • the helical return spring 590 shown in fig. 8 is generally open wound but to prevent tangling during manufacturing the spring is provided with distal, central and proximal tightly wound sections.
  • the generally tubular control member 700 comprises an outer helical flange 710 serving to control axial movement of the control member relative to the housing.
  • the helical flange comprises a helical distal surface 713 adapted to engage the helical surface 433 on the tower, a helical proximal surface 719 adapted to engage the distal end of the actuation knob 516, and a longitudinally extending control edge 714 (serving as a control surface) connecting the ends of the helical flange 710 and being adapted to engage the stop edge 434 on the housing tower.
  • an axially oriented release flange 716 is arranged on the outer surface of the control member.
  • the control edge 714 extends to form a pointed catch 715 adapted to be seated the tower notch 435.
  • the majority of the helical flange 710 has a first larger diameter whereas cut-out portions 711 on each side of the control edge 714 have a smaller diameter corresponding to the height of the control edge, this allowing the actuator knob 516 to axially pass.
  • the control member further comprises a distally oriented helical edge 720, the ends of the helical edge being connected with an axially oriented second control edge 729 adapted to engage tower stop knob 439.
  • the control member inner surface comprises an opposed pair of spline ridges 730 adapted to engage corresponding spline slots in the drive tube. At the distal end and aligned with the spline ridges an opposed pair of stop flanges 735 are arranged adapted to engage the piston rod stop surface 655.
  • the drive member 800 comprises a proximal cylindrical spring housing portion 801 and a distal drive tube portion 802.
  • the drive tube portion comprises at the distal end an inner pair of opposed axially oriented drive flanges 810 adapted to engage the piston rod drive grooves.
  • a pair of opposed spline slots 830 is provided adapted to engage the corresponding control member spline ridges 730.
  • the spline slots may comprise friction structures providing that the control member cannot slide freely on the drive member tube portion 802.
  • the spring housing 801 comprises at the distal end an inner circumferential flange creating a circumferential groove 820 adapted to receive the distal end of the drive spring, the groove comprising an oblong catch opening 821 adapted to receive the drive spring distal hook.
  • the spring housing comprises an opposed pair of flexible arms 822 protruding slightly into the interior of the spring housing, the arms being adapted to engage and axially hold the spring in place during assembling.
  • an outer part-circumferential support flange 823 is provided to ensure concentricity between the drive member 800 and the spring base 900, as well as a single circumferentially oriented and outwardly protruding flexible clicker finger 825 having a free end adapted to rotationally engage a circumferential ratchet surface 915 on the spring base 900.
  • Fig. 11 shows the piston rod 650 comprising along its length a thread 651 as well as a pair of opposed drive grooves 652.
  • the proximal end comprises a distally facing stop flange 655 adapted to engage the control member stop flanges 735.
  • the distal end 654 is adapted to engage the piston washer 395 which in the shown embodiment is a flat disk.
  • the piston washer may be provided with proximally facing centring means adapted to engage the piston rod distal end, e.g. the piston washer and the piston rod distal end may be provided with corresponding snap coupling structures.
  • the drive spring 890 as shown in fig. 12 is a tight wound helical spring without any spacing between adjacent coils and comprises a distal hook portion 891 arranged in an axial plane and a proximal hook portion 892 arranged in a transversal plane.
  • the spring base 900 comprises a proximal planar end surface 901 from which extend in the distal direction an outer circumferential skirt 902, an inner circumferential skirt 910 with a distal support edge 912 for the return spring 590 proximal end, as well as a central tower portion 920 providing an inner support for the drive spring.
  • the inner surface of the inner skirt comprises a circumferential ratchet surface 915 adapted to engage clicker finger 825.
  • the inner skirt further comprises an opposed pair of catch openings 911 adapted to engage the housing snap lock finger hooks 421.
  • each finger comprising a longitudinally extending free spring edge 932 adapted to engage the drive spring proximal hook 892 in axial sliding engagement.
  • the sliding engagement allows the spring base to be inserted into the housing after the spring has been strained just like the spring hook can slide on the spring edge as the spring shortens during de-straining.
  • fig. 14 shows a cross-sectional view of the assembled device.
  • the strained drive spring 890 is arranged in the spring housing 801 providing a rotational force to the piston rod 650 via the drive tube portion 802 and thereby distal axial movement through the treaded engagement with the drive nut 600.
  • the drive tube portion 802 is in splined engagement with the control member 700 and thus prevented from rotating as long as the control member is in its rotationally “parked” position with the control member control edge 714 engaging the tower stop edge 434 (see below).
  • the control member is released from the parked position when moved proximally by the actuator member when the latter is moved proximally by the needle unit shield (see below).
  • Fig. 15 shows in a detail view how the drive spring proximal hook 892 engages a longitudinally extending free spring edge 932 in axial sliding engagement.
  • Fig. 16 shows in a detail view how the drive spring distal hook 891 has been rotated into engagement with the catch opening 821.
  • Fig. 17 shows in a detail view how a drop lock finger 521 engages the housing drop lock surface 407 to prevent accidental axial movement of the actuator.
  • the figure also shows the piston rod 650 engaging the cartridge piston 392 via the piston washer 395.
  • the shown embodiment may be assembled in the following steps: (i) The drive nut 600 is inserted in the housing snapping in place with an axial play, (ii) the control member 700 is inserted in the housing tower with the stop and control edges aligned, (iii) the actuator 500 is inserted with the legs arranged in the housing cartridge portion and with the cylindrical proximal portion 501 surrounding the control member and housing tower, shoulders on the housing inner wall serving to deflect the legs inwardly allowing them to be moved into the cartridge portion, (iv) the drive member drive tube portion 802 is inserted in the housing tower, (v) the return spring 590 is inserted distally engaging the actuator spring support flange 510 and proximally temporarily being held in place by the housing snap lock finger hooks 421 , (vi) the piston rod 650 is inserted in the drive tube which is turned 180 degrees back and forth to allow the piston rod thread to engage the drive nut thread, (vii) the drive spring 890 is inserted in the spring housing 801 with the drive spring distal hook being
  • the cartridge holder In addition to the cartridge being forced into engagement with the cartridge holder distal portion, also the cartridge holder is forced distally into engagement with the housing, e.g. the window wall 316 distal end is forced into engagement with the housing window 416 distal end, to thereby eliminate axial play between the cartridge and the housing.
  • the piston washer 395 engages the piston rod distal end whereby the piston rod and the drive nut are moved slightly proximally with no gap being formed between the piston rod and the piston washer, and (xii) the drive nut is fused to the housing by application of e.g. a laser beam through housing nut openings 406.
  • a label (not shown) is applied to the housing proximal portion to cover the snap locks and the nut openings.
  • a modified piston washer is snapped onto a modified piston rod before the cartridge holder is inserted into the housing, this preventing the piston washer from being dislocated before it is engaged by the piston rod.
  • the actuator legs 502 are engaged by the needle unit hub 100 and shield 200 whereby the actuator is rotated (here: 20 degrees) from the initial lock position to an actuated un-locked position in which (i) the drop lock fingers 521 are no longer aligned with the housing drop lock surfaces 407, this allowing the actuator to subsequently be moved proximally, (ii) the PONR wedges 530 are aligned with the housing PONR flexible arms 408, and (iii) the anti-rotational clutch 517 is moved from its initial to its actuated position, the latter being described in greater detail below in connection with mounting of the needle unit.
  • fig. 18A shows (in part) the device in its pre-dosing state after a needle unit has been mounted.
  • the control member 700 is positioned in its distal-most position with the control edge 714 engaging the tower stop edge 434, this preventing the drive spring from rotating the drive tube 802 as the control member and the drive tube are in splined engagement.
  • the second control edge 729 engages tower stop knob 439.
  • the actuation knob 516 has been rotated into alignment with the release flange 716.
  • the actuator When the user inserts the needle of the needle unit subcutaneously (see below), the actuator is moved proximally by the needle shield against the force of the return spring, the actuator actuation knob 516 thereby moving over the control edge 714 and into engagement with the control member release flange 716 distal end. As the drop lock flange 511 moves with the actuator knob 516 the control member can be moved proximally. When the needle shield and thus the control member have been moved to their proximal-most position the control member control edge 714 has been moved out of axial engagement with the tower stop edge 434 (see fig.
  • the actuator PONR wedges 530 have been moved over the housing PONR stop surfaces (allowed by the flexibility of PONR flexible arms 408), this preventing the actuator, and thus the needle shield, from being returned to their initial position.
  • the nonreturned needle shield will indicate to the user that actuation of the device is “in progress” and that an injection should be performed.
  • the PONR arrangement prevents the return spring exerting a force to the control member via the activation knob 516. If this was allowed, it would create friction and slow down dose delivery.
  • Fig. 18D shows the state just prior to end-of-dose.
  • the control member control edge 714 approaches engagement with the tower stop edge 434 and the control member release flange 716 approaches the actuation knob 516.
  • the control and stop edges engage each other, and rotation and out-dosing come to an end-state.
  • the release flange 716 has rotated the actuation knob 516 and thus the connector back to its initial rotational lock position (see fig. 18E).
  • the actuation knob 516 is aligned with the flange cutout 711 which would allow the control member to move proximally, e.g. by gravity if the device was used in an upside-down orientation, this moving the control edge 714 axially out of engagement with the tower stop edge 434 thereby allowing the control member 700 to continue rotating and thus a further dose to be expelled.
  • the splined engagement 730, 830 between the control member and the drive tube may be provided with friction structures, the friction being easily overcome by the energy provided by the drive spring but not by gravity.
  • the control member may comprise an integrated return spring or an additional helical spring may be position between the two components.
  • the actuation knob 516 When the user withdraws the needle from the skin, the actuation knob 516 is aligned with the flange cut-out 711 allowing the return spring to move the actuator (see fig. 18F) and thereby also the needle shield distally to their initial distal-most positions.
  • the actuator drop lock fingers 521 are rotationally aligned with the housing drop lock surfaces 407, however, due to their flexibility they will pass over the drop lock surfaces.
  • the PONR wedges 530 are moved out of rotational alignment with the housing PONR stop surfaces 409. As the actuator is moved distally the drop lock flange 511 (hidden in fig. 18F, see fig.
  • the control member 300, the actuator 500, and the drive member 800 have returned to their initial positions, whereas the piston rod has been moved distally corresponding to the pre-set dose size and the drive spring has been de-strained corresponding to a single dose.
  • the piston rod stop surface 655 is positioned in close proximity to control member stop flanges 735, this preventing the control member to be further actuated.
  • a stop surface between piston rod and nut can could prevent the piston rod from rotating further and thereby prevent activation of the device.
  • a single axially oriented stop edge and a single axially oriented control edge is provided, this allowing the control member to rotate 360 degrees between the control edge disengaging and re-engaging the stop edge.
  • two stop edges spaced 180 degrees apart are provided, this allowing a correspondingly modified control member to rotate 180 degrees between the control edge disengaging and re-engaging a stop edge.
  • three stop edges spaced 120 degrees apart are provided, this allowing a correspondingly modified control member to rotate 120 degrees between the control edge disengaging and re-engaging a stop edge.
  • Such modified the above-described drug delivery device could be adapted to expel 8 or 12 fixed volume doses instead of four as disclosed.
  • the needle shield has been locked in its distal position and thus prevents the dose engine to be released, this providing protection against double-dosing. To allow a further dose to be expelled a new needle unit has to be mounted.
  • the housing distal end comprises an indicator opening 405.
  • an indicator portion on the hub member moves into alignment with the indicator opening, this indicating that a dose of drug has been expelled.
  • the drug delivery device 1 is adapted to receive a shielded needle unit 2, comprising a needle hub 100 adapted to be mounted on a corresponding mount on the drug delivery device, a subcutaneous hollow needle 101 mounted in the hub and comprising a pointed free distal end portion adapted to be inserted subcutaneously through the skin of a user and a pointed free proximal end portion adapted to be penetrate a pierceable drug cartridge septum, as well as a shield member 200 in which the needle hub is arranged.
  • the subcutaneous hollow needle 200 comprises bevelled proximal and distal ends and is arranged in a hub bore and secured in place by e.g. adhesive.
  • the needle unit is supplied as a needle assembly further comprising a container 280 (see fig. 22) adapted to receive the needle unit in an assembled state, the container having an open end adapted to be sealed with a flexible foil member thereby providing a sealed, sterile interior for the needle unit when supplied to the user.
  • Fig. 1 shows a needle unit 2 mounted on an injection device 1 adapted to releasably receive the needle unit.
  • the shield has an outer super-elliptic cross-section configuration allowing it to be received in the correspondingly formed distal opening of the injection device 3.
  • other non-circular designs could be implemented, e.g. square or triangular, or the needle unit could have a circular design with rotational orientation being provided by cooperating guide structures.
  • the needle hub 100 (in the following also just “hub” or “hub member”) and the shield member 200 (in the following also just “shield”) comprise a number of interacting structures allowing the shield and hub to move axially and rotatably relative to each other in a controlled manner during use and operation of the needle unit.
  • the shield is rotationally locked relative to the cartridge mount and the hub is axially locked relative to the cartridge mount when the needle unit is mounted on the cartridge mount. Rotational movement of the hub is controlled by axial movement of the shield relative to the cartridge mount and thus the hub.
  • the container and the shield member comprise interacting structures allowing the container to be used as a mounting and removal tool for the needle assembly during use in an efficient and user-friendly manner.
  • the shield, hub and container generally comprise functional structures in opposed pairs, however, any suitable numbers of such structures could be used, e.g. one, two or three.
  • the shield 200 has a generally tubular configuration with a circumferential outer wall 210, a proximal opening with a circumferential edge 211 , and a distal end surface 201 with a smaller distal opening 212 from which a tower structure protrudes axially inwardly.
  • the tower structure comprises a circumferential skirt portion 215 from which first and second pairs of opposed arms extend proximally with a rotational offset of 90 degrees in the shown embodiment. Between the arms the skirt portion comprises free grip edge portions 216.
  • the first pair of longer arms are in the form of flexible assembly arms 220 each having a hook portion 225 at the proximal free end with a distally facing axial stop surface 221 adapted to engage corresponding proximally facing stop surfaces 121 on the hub tower portion (see below) as well as a proximally facing ramp surface 222 used during assembling of the needle unit.
  • the second pair of shorter arms is in the form of flexible control arms 230 each having a hook portion 235 at the proximal free end with a proximally facing ramp surface 231 and a distally facing control surface 232, the surfaces being adapted to engage corresponding distally facing ramp surfaces respectively proximally facing control surfaces on the hub tower portion (see below).
  • the shield comprises opposed pairs of inner actuation ribs 213 adapted to engage corresponding flexible hub arms (see below).
  • the actuation ribs 213 also serve to lock the coupling arms (see below) and to centre the generally circular hub in the super-elliptic shield and thus assure stability during axial and rotational movement between the hub and shield during operation.
  • the shield further comprises a pair of opposed locking ribs 217 on the shield inner wall surface, each rib having a proximally facing locking surface 218 adapted to engage a corresponding locking surface on the hub.
  • the locking ribs proximally extend into lower torque ribs 219 adapted to engage torque flanges on the hub (see below).
  • the shield wall 210 is further provided with an outer pair of opposed mounting ribs 245 adapted to engage corresponding shield slots 415 in the housing, a pair of opposed windows 240 adapted to allow outwards movement of the hub coupling arms (see below), as well as a first indicator opening 241 and a second indicator opening 246.
  • the first indicator opening 241 is “open” as for design reasons the shield edge 211 comprises cutouts for structures in the drug delivery device.
  • the hub 100 comprises a distal tower portion 110 comprising a central bore 111 adapted to receive a subcutaneous needle as well as a proximal skirt portion 120.
  • the tower portion comprises three pairs of opposed function surfaces adapted to cooperate with corresponding surfaces on the shield: (i) a pair of proximally facing stop surfaces 121 adapted to engage the distally facing stop surfaces 221 on the shield assembly arms, (ii) a pair of distally facing ramp surfaces 131 adapted to engage the proximally facing ramp surfaces 231 on the shield, and (iii) a pair of inclined proximally facing control surfaces 132 adapted to engage the distally facing control surfaces 232 on the shield during operation.
  • the tower portion comprises a pair of opposed snap indentations 135 adapted to engage the control arm hook portions 235.
  • the skirt portion 120 comprises an opposed pair of proximally extending flexible coupling arms 126, each arm having an outer surface 123 adapted to engage the shield inner actuation ribs 213 during operation, and an inwardly facing snap coupling ridge 127 arranged at the free proximal end of the coupling arm and adapted to engage a corresponding coupling structure on the cartridge mount 310.
  • the skirt portion further comprises a pair of distally facing lock surfaces 118 adapted to engage the proximally facing shield locking surfaces 218 during operation.
  • the skirt portion further comprises a pair of radially protruding opposed drop lock release flanges 114 adapted to engage the actuator leg release surfaces 524, a pair of radially protruding opposed torque flanges 119 adapted to engage the shield torque ribs 219, as well as a pair of opposed indicator cut-outs 115.
  • the torque interface could also be located on other portions of the shield and the hub, e.g. between the assembly arms and the hub tower portion.
  • the container 280 has a generally tubular configuration with a super-elliptic circumferential outer wall 281 , a proximal opening with a circumferential flange 282 and a closed distal end 283 from which a tower structure 285 and a pair of opposed snap lock fingers 290 extend axially inwardly.
  • the snap lock fingers each comprises an outwardly oriented snap protrusion 296 adapted to releasably engage the shield tower grip edge portions 216 to provide a snap coupling.
  • the container further comprises a plurality of inner support ribs 286 adapted to engage the shield outer surface and support the shield when arranged in the container.
  • the proximal portion With the shield mounted in the container the proximal portion provides a circumferential space 299 (see fig. 22) between the container and the shield allowing the correspondingly shaped drug delivery housing portion to be received therein during mounting of the needle unit on the drug delivery device.
  • the hollow subcutaneous needle 101 with bevelled proximal and distal ends is arranged in the hub bore and secured in place, e.g. by means of adhesive, this providing a free distal end portion 102 and a free proximal end portion 103.
  • the hub 100 is subsequently inserted in the shield 200 with the stop surfaces 121 and the ramp surfaces 131 rotationally aligned with the shield stop surfaces 221 respectively the shield ramp surfaces 231 , this allowing the shield stop surfaces to snap into engagement with the hub stop surfaces 121 .
  • the hub coupling arms 126 are rotationally aligned with the shield actuation ribs 213.
  • the hub proximal end is arranged slightly proximally of the shield proximal edge 211 .
  • the assembled needle unit is then inserted into the container with the container snap lock fingers 290 snapping into engagement with the shield tower grip edge portions 216. As seen in fig. 22 an axial gap is provided between the container tower proximal end and the hub tower distal end.
  • a flexible foil member (not shown) is attached to the container proximal flange 282 thereby sealing the interior for subsequent sterilization.
  • Fig. 22 shows in cross-section the needle assembly with the needle unit positioned in the container before the seal foil is attached.
  • the container is intended to be used as a tool to mount the needle unit on the drug delivery device 1 with a corresponding cartridge mount 310, see fig. 23A.
  • the cartridge mount is arranged proximally of the distal end of the drug delivery device housing cartridge portion 402 with a circumferential space between the cartridge holder 300 and the housing adapted to receive the shield 200 proximal portion in non-rotational engagement by the cooperating mounting ribs 245 and shield slots 415.
  • the non-circular design makes it easy for the user to orient the needle assembly rotationally correct relative to the drug delivery device in either of its two possible rotational positions.
  • the locked hub coupling arms 126 engage the cartridge mount coupling flange portions 311 , this allowing the shield to be pushed forward by the container to an axial position in which the shield actuation ribs 213 are not engaging the flexible hub arm outer surfaces 123, see fig. 23B.
  • the control arms 230 are free to bend outwardly to allow proximal shield movement, but they will not snap overthe ramp surfaces 131. It is to be noted that in fig. 23B the two structures for drawing reasons are shown as overlapping. Alternatively, a clearance could be provided between the two structures.
  • the container assures that the shield and hub can be pushed firmly into engagement with the cartridge mount by the user, this allowing the free proximal needle end portion 103 to penetrate the cartridge septum 394 and the flexible hub coupling arms 126 to be initially moved radially outwards in the receiving shield windows 240 and subsequently snap radially inwards into engagement with the corresponding snap coupling flanges 311 on the cartridge mount, see fig. 23C.
  • the hub drop lock release flanges 114 engage the inclined leg release surfaces 524 on the spring-biased actuator legs 502.
  • the actuator is moved axially until the anti-rotational clutch portions 517 are moved out of engagement with the housing, this allowing the actuator to be rotated by the axial movement of the hub.
  • the hub is supported by the shield (which is non-rotationally coupled to the housing 400) via the torque flanges 119 engaging the torque ribs 219.
  • the shield actuator ribs 213 engage the leg actuation surfaces 523 of the actuator legs 502 and moves axially together with the drop lock release flanges 114.
  • the actuator may be fully rotated (here: 20 degrees) during mounting of the needle unit. Alternatively, final rotation of the actuator may take place when the actuator subsequently is allowed to be moved distally by the return spring 590.
  • Axial mounting movement of the needle unit stops when the hub engages the cartridge mount, this indicating to the user that the needle unit has been mounted on the cartridge hub.
  • the spring-biased actuator legs 502 will push the shield 200 slightly distally until the distally facing axial stop surfaces 221 on the shield assembly arms engage the corresponding proximally facing stop surfaces 121 on the hub tower portion.
  • the control arms 230 are moved back to their initial position.
  • the clutch portions 517 reengage with the housing lock ribs 447 in the actuated rotational position.
  • the shield actuation ribs 213 will move into engagement with the flexible hub arm outer surfaces 123 and thereby prevent radial outwards movement thereof, this securely locking the hub 100 to the cartridge mount 310 corresponding to an actuated hub coupling lock state in which a mounted needle unit cannot be removed from the drug delivery device, see fig. 23D.
  • the container snap coupling 296 will disengage the shield 200.
  • the drug delivery device with the mounted needle unit is ready for use as shown in fig. 23E.
  • the housing indicator opening 405 is aligned with a shield first indicator opening 241 and a hub indicator cut-out 115.
  • the hub skirt 120 is thus not visible to the user (see fig. 24A).
  • the shield 200 When the user pushes the needle unit towards a skin surface the shield 200 is pushed proximally allowing the needle distal end 103 to be inserted subcutaneously.
  • the ramp surfaces 231 on the flexible control arms 230 are pushed over the hub tower ramp surfaces 131.
  • the shield actuator ribs 213 pushes the pair of actuator legs 502 proximally to thereby release the drug delivery device expelling mechanism thereby starting subcutaneous injection as described above, see fig. 23F.
  • the actuator legs 502 serve both as a locking actuator for the hub coupling and as release members for the expelling mechanism.
  • the shield is held in its fully retracted position by the snap lock 135, 235.
  • the housing indicator opening 405 is aligned with the shield second indicator opening 246 and the hub indicator cut-out 115.
  • the hub skirt 120 is thus not visible to the user (see fig. 24B).
  • the user withdraws the needle unit from the skin surface thereby allowing the spring-biased actuator legs 502 to push on the shield actuation ribs 213 to thereby move the shield 200 distally to its fully extended position again covering the needle distal portion 103.
  • the control surfaces 232 on the control arms 230 will engage the inclined proximally facing control surfaces 132 on the hub tower (see fig. 20A), which will force the needle hub 100 to rotate as the shield is rotationally locked to the drug delivery device, see fig. 23G.
  • the hub is rotated 45 degrees relative to the shield, compare figs. 23CX and 23GX.
  • the hub and shield can be designed with an axial “play” before the shield control surfaces 232 engages the inclined hub control surfaces 132, this allowing the needle to be at least partly withdrawn from the skin before rotation starts. Indeed, the later rotation starts the steeper the inclination of the hub control surfaces has to be.
  • the pair of locking ribs 217 on the shield inner surface were free to move in the axial direction thus allowing the shield to be moved from its extended to its retracted position.
  • the pair of distally facing locking surfaces 118 are rotated into alignment with the proximal ends 218 of the locking ribs 217 thereby preventing repeated retraction of the shield and thus use of the needle unit, thereby providing a safety lock, see figs. 19B and 20A.
  • the locking surfaces should be designed to withstand relatively large forces to prevent re-activation of the needle unit, e.g. if the pen device is dropped on a hard surface or in a mis-use scenario. Further, in case the drug delivery device as in the present embodiment is shield released the shield lock will also serve as a double dose prevention means.
  • the container is intended to be used as a tool also for removing the needle unit, see fig. 23I.
  • the container snap coupling 296 will engage the shield 200.
  • the container snap coupling is designed to have a release force larger than the release force necessary to pull the ridges 127 of the flexible hub coupling arms axially out of engagement with the cartridge mount release flanges 312, this allowing the needle unit to be removed from the cartridge mount securely held in the container after which it can be safely discarded, see fig. 23J.
  • the proximal end is positioned a certain distance inside the container and only being surrounded by a small free space, removal of the needle unit from the container would be difficult.
  • the flexible coupling arms 126 when the hub rotates relative to the cartridge mount the flexible coupling arms 126 are rotated to align with the inclined release flanges 312 allowing the hub coupling arms to disengage with ease which may encourage the user to remove the needle unit without using the container.
  • the release flanges may be modified to require a larger release force which would make it more difficult to merely grab and pull the shield out of engagement with the hub mount.
  • the snap coupling between the container and the shield has to be able to transfer the required force, however, as the same snap coupling should be designed to allow for easy removal of the container after initial mounting of the needle unit this may not be desirable.
  • a needle assembly comprising a snap coupling between the container and the shield, the snap coupling being actuatable between a first state in which the needle unit can be removed from the container using a first amount of force, and a second state in which the needle unit can be removed from the container using a second higher amount of force.
  • the assembly may be operated between the two states by the rotational movement of the hub inside the shield.
  • an indicator is incorporated in the drug delivery housing and being operated by the rotational movement of the hub.
  • indicator actuation is controlled by the needle unit
  • the placement of the indicator window 405 on the housing is designed to associate the indicator with operation of the device per se and thus indicate that a dose of drug has been expelled which will be the case when the shield has been returned to its extended and now locked position.
  • the shield instead of the device housing the shield may be provided with an indicator window and the hub may be provided with an indicator surface which initially is not aligned with the window but moved into alignment therewith when the hub is rotated after use.

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

Abstract

L'invention concerne un dispositif d'administration de médicament comprenant un boîtier dans lequel une base de ressort peut être insérée, un élément d'entraînement conçu pour faire tourner une tige de piston, et un ressort d'entraînement hélicoïdal ayant une extrémité distale accouplée à l'élément d'entraînement et une extrémité proximale accouplée à la base de ressort. L'extrémité proximale de ressort d'entraînement hélicoïdal comprend une partie en forme de crochet disposée dans un plan transversal, et la base de ressort comprend un bord libre orienté axialement conçu pour venir en prise avec la partie en forme de crochet, ce qui permet à la partie en forme de crochet et au bord libre de coulisser axialement l'un par rapport à l'autre.
PCT/EP2024/083576 2023-11-28 2024-11-26 Dispositif d'administration de médicament à ressort d'entraînement Pending WO2025114261A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP23212598 2023-11-28
EP23212598.9 2023-11-28
EP24156806.2 2024-02-09
EP24156806 2024-02-09

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WO2025114261A1 true WO2025114261A1 (fr) 2025-06-05

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6899699B2 (en) 2001-01-05 2005-05-31 Novo Nordisk A/S Automatic injection device with reset feature
US20130281943A1 (en) 2010-11-08 2013-10-24 Owen Mumford Limited Injection device
WO2014161952A1 (fr) 2013-04-05 2014-10-09 Novo Nordisk A/S Dispositif d'enregistrement de dose destiné à un dispositif d'administration de médicament
WO2017098460A1 (fr) 2015-12-11 2017-06-15 Copernicus Sp. Z O.O. Système de commande pour dispositif d'injection
WO2018007259A2 (fr) 2016-07-07 2018-01-11 Copernicus Sp. Z O.O. Dispositif d'injection pour administrer un nombre défini de doses égales d'une substance fluide
US20190328969A1 (en) 2015-11-16 2019-10-31 Sanofi Drug Delivery Device
WO2020089167A1 (fr) 2018-10-30 2020-05-07 Novo Nordisk A/S Dispositif d'injection entraîné par un ressort de torsion
US20220409820A1 (en) 2019-12-18 2022-12-29 Novo Nordisk A/S An injection device for delivering a predefined plurality of predetermined dose volumes

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6899699B2 (en) 2001-01-05 2005-05-31 Novo Nordisk A/S Automatic injection device with reset feature
US20130281943A1 (en) 2010-11-08 2013-10-24 Owen Mumford Limited Injection device
WO2014161952A1 (fr) 2013-04-05 2014-10-09 Novo Nordisk A/S Dispositif d'enregistrement de dose destiné à un dispositif d'administration de médicament
US20190328969A1 (en) 2015-11-16 2019-10-31 Sanofi Drug Delivery Device
WO2017098460A1 (fr) 2015-12-11 2017-06-15 Copernicus Sp. Z O.O. Système de commande pour dispositif d'injection
WO2018007259A2 (fr) 2016-07-07 2018-01-11 Copernicus Sp. Z O.O. Dispositif d'injection pour administrer un nombre défini de doses égales d'une substance fluide
WO2020089167A1 (fr) 2018-10-30 2020-05-07 Novo Nordisk A/S Dispositif d'injection entraîné par un ressort de torsion
US20220409820A1 (en) 2019-12-18 2022-12-29 Novo Nordisk A/S An injection device for delivering a predefined plurality of predetermined dose volumes

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