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WO2025133224A2 - Système d'administration de médicaments, cartouche et dispositif injecteur réutilisable - Google Patents

Système d'administration de médicaments, cartouche et dispositif injecteur réutilisable Download PDF

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Publication number
WO2025133224A2
WO2025133224A2 PCT/EP2024/088064 EP2024088064W WO2025133224A2 WO 2025133224 A2 WO2025133224 A2 WO 2025133224A2 EP 2024088064 W EP2024088064 W EP 2024088064W WO 2025133224 A2 WO2025133224 A2 WO 2025133224A2
Authority
WO
WIPO (PCT)
Prior art keywords
needle cover
cartridge
injector device
outer housing
needle
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/EP2024/088064
Other languages
English (en)
Other versions
WO2025133224A3 (fr
Inventor
Tobias CHARLES
Alexander Hee-Hanson
Thomas LEVER
Gregory SALE
Robert Wilson
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.)
Sanofi SA
Original Assignee
Sanofi SA
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 Sanofi SA filed Critical Sanofi SA
Publication of WO2025133224A2 publication Critical patent/WO2025133224A2/fr
Publication of WO2025133224A3 publication Critical patent/WO2025133224A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/121—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit interface between cassette and base
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle

Definitions

  • the present invention relates to a medicament delivery system comprising a cartridge and a reusable injector device.
  • Medicament delivery devices such as auto-injectors, are known in the art for dispensing a medicament to an injection site of a patient.
  • Such medicament delivery devices typically comprise a needle in fluid communication with a syringe and a piston rod that is moveable to dispense a medicament within the syringe through the needle into the injection site.
  • the piston rod may be actuated to dispense the medicament.
  • the needle may be covered by a needle shield and/or a needle cover and the medicament delivery device may be disposed of.
  • a medicament delivery system comprising a reusable injector device and a cartridge for use with the reusable injector device, the cartridge and the reusable injector device being combinable for medicament delivery and separable thereafter
  • the cartridge comprises: a cassette outer housing; a pre-filled syringe arranged within cassette outer housing, the pre-filled syringe comprising a needle; and a needle cover arranged within the cassette outer housing and surrounding the pre-filled syringe
  • the reusable injector device comprises: a housing; a needle cover shuttle displaceable within the housing against a needle cover shuttle spring; and a plunger rod configured to dispense medicament from the pre-filed syringe in use; and wherein, when the cartridge and the reusable injector device are coupled, the needle cover shuttle engages the needle cover to bias the needle cover in a proximal direction.
  • a medicament delivery system in which components of the system are reusable, reducing waste. Furthermore, the invention improves safety by ensuring that the needle cover is automatically biased by the needle cover shuttle spring to cover the needle, wherein this biasing is simply and intuitively initiated by a user coupling the cartridge to the reusable injector device.
  • the medicament delivery system may be configured such that, when the cartridge and the reusable injector device are coupled, the needle cover is configured to be translated distally within the cassette outer housing from a primed position, in which the needle is surrounded by the needle cover, to a dose delivery position, in which at least a proximal end of the needle extends proximally outside of the needle cover for injection into an injection site.
  • the medicament delivery system may be configured such that, when the cartridge and the reusable injector device are coupled, the needle cover is configured to be translated proximally within the cassette outer housing from the dose delivery position to a post-dose delivery position, in which the needle does not extend proximally outside of the needle cover.
  • the needle is re-covered after dose delivery and safety of the system is improved.
  • the medicament delivery system may be configured such that, when the cartridge and the reusable injector device are coupled, the needle cover is biased to translate proximally within the cassette outer housing from the dose delivery position to the post-dose delivery position by the needle cover shuttle.
  • covering of the needle may be automatic in response to a user removing the medicament delivery system from an injection site, increasing safety of the system.
  • the medicament delivery system may be configured such that, after the needle cover has moved from the dose delivery position to the post-dose delivery position, distal movement of the needle cover is inhibited by a needle cover return lock of the cartridge.
  • the needle cover return lock may comprise a needle cover locking arm extending from the needle cover and a locking recess arranged in the cassette outer housing, the needle cover locking arm configured to become engaged with the locking recess to inhibit distal movement of the needle cover.
  • the needle cover may be configured to be rotated within the cassette outer housing from an initial position to the primed position, wherein distal translation of the needle cover within the cassette outer housing is inhibited when the needle cover is in the initial position.
  • the cartridge may further comprise a cap coupled to the cassette outer housing, wherein rotation of the needle cover from the initial position to the primed position is responsive to removal of the cap from the cassette outer housing.
  • the medicament delivery system may be configured such that the cap cannot be removed from the cassette outer housing without rotating the needle cover.
  • the cap may comprise a guide pin configured to be received in a track formed in the cassette outer housing, the guide pin configured to traverse the track during removal of the cap.
  • Rotation of the needle cover from the initial position to the primed position may be inhibited until the cartridge is coupled to the reusable injector device.
  • Rotation of the needle cover from the initial position to the primed position may be inhibited by a needle cover locking mechanism of the cartridge, and the needle cover locking mechanism may be configured to be engaged by an unlocking element of the reusable injector device when the cartridge is coupled to the reusable injector device, to unlock the needle cover for rotation.
  • the needle cover locking mechanism may comprise a clip configured to releasably engage with the needle cover to inhibit rotation of the needle cover.
  • the clip may be configured to be lifted out of a first cutout in the needle cover by the unlocking element, such that the needle cover is free to rotate from its initial position to its primed position.
  • the reusable injector device may comprise at least one interlock arm displaceable to engage a respective recess in the cassette outer housing to couple the cartridge to the reusable injector device.
  • Uncoupling of the cartridge from the reusable injector device may be inhibited during delivery of medicament.
  • a reusable injector device for use with a cartridge, the cartridge comprising a cassette outer housing containing a pre-filled syringe and a needle cover, the reusable injector device comprising: a housing; a needle cover shuttle displaceable within the housing against a needle cover shuttle spring; and a plunger rod configured to dispense medicament from the pre-filed syringe in use; wherein, when the cartridge and the reusable injector device are coupled, the needle cover shuttle engages the needle cover of the cartridge to bias the needle cover in a proximal direction.
  • a injector device which can be reused with multiple disposable cartridges, reducing waste compared to an injector device with an integrated cartridge. Furthermore, the invention improves safety by ensuring that the needle cover of a cartridge is automatically biased by the needle cover shuttle spring to cover a needle in the cartridge, wherein this biasing is simply and intuitively initiated by a user coupling the cartridge to the reusable injector device.
  • the reusable injector device may be configured to couple to the cassette outer housing of the cartridge.
  • the reusable injector device may comprise at least one interlock arm displaceable to engage a respective recess in the cassette outer housing to couple the reusable injector device to the cartridge.
  • the at least one interlock arm may be arranged to be displaced towards the respective recess responsive to displacement of the plunger rod during delivery of medicament.
  • the plunger rod may comprise at least one recess to receive an outer end of the at least one interlock arm, wherein the at least one recess and the at least one interlock arm may be arranged such that proximal translation of the plunger rod disengages the outer end of the at least one interlock arm from the at least one recess to displace the at least one interlock arm for engaging the recess in the cassette outer housing.
  • Uncoupling of the cartridge from the reusable injector device may be inhibited during delivery of medicament.
  • the reusable injector device may be configured such that, when the reusable injector device is coupled to the cartridge and the needle cover is displaced distally, a distal end of the needle cover is received within the housing and the needle cover displaces the needle cover shuttle distally against the bias of the needle cover shuttle spring.
  • the reusable injector device may comprise an unlocking element configured to engage with a needle cover locking mechanism of the cartridge once the cartridge is coupled to the reusable injector device to allow for rotation of the needle cover with respect to the cassette outer housing.
  • the reusable injector device may further comprise a plunger rod driving mechanism for driving the plunger rod.
  • the reusable injector device may be reused to deliver medicament from multiple cartridges, thereby reducing wastage.
  • a cartridge for use with a reusable injector device comprising: a cassette outer housing; a pre-filled syringe arranged within cassette outer housing, the pre-filled syringe comprising a needle; and a needle cover arranged within the cassette outer housing and surrounding the pre-filled syringe.
  • a cartridge for use with a reusable injector device is provided.
  • a simple, single-use cartridge that is easy to manufacture and has few components, many of the remaining components required for a medicament delivery process to be performed can be integrated into the reusable injector device, thereby reducing wastage.
  • a needle cover in the cartridge ensures user safety before, during and after coupling of the cartridge to the reusable injector device.
  • the needle cover may be configured to be engaged by a needle cover shuttle of the reusable injector device to bias the needle cover in a proximal direction, when the cartridge and the reusable injector device are coupled.
  • the cartridge may be configured such that, when the cartridge is coupled to the reusable injector device, the needle cover is configured to be translated distally within the cassette outer housing from a primed position, in which the needle is surrounded by the needle cover, to a dose delivery position, in which at least a proximal end of the needle extends proximally outside of the needle cover for injection into an injection site.
  • the needle cover may be configured to be translated proximally within the cassette outer housing from the dose delivery position to a post-dose delivery position, in which the needle does not extend proximally outside of the needle cover.
  • the needle is re-covered after dose delivery and safety of the system is improved.
  • a needle cover return lock After the needle cover has moved from the dose delivery position to the post-dose delivery position, distal movement of the needle cover is inhibited by a needle cover return lock.
  • the needle cover return lock may comprise a needle cover locking arm extending from the needle cover and a locking recess arranged in the cassette outer housing, the needle cover locking arm configured to become engaged with the locking recess to inhibit distal movement of the needle cover. Therefore, a simple mechanism for improving safety of the system is provided.
  • the needle cover may be configured to be rotated within the cassette outer housing from an initial position to the primed position, and distal translation of the needle cover within the cassette outer housing may be inhibited when the needle cover is in the initial position.
  • the cartridge may further comprise a cap coupled to the cassette outer housing, wherein rotation of the needle cover from the initial position to the primed position is responsive to removal of the cap from the cassette outer housing.
  • the cartridge may be configured such that the cap cannot be removed from the cassette outer housing without rotating the needle cover.
  • the needle cover locking mechanism may comprise a clip configured to releasably engage with the needle cover to inhibit rotation of the needle cover.
  • a method of using any medicament delivery system as described herein comprising coupling the cartridge to the reusable injector device.
  • FIG. 1 is a perspective view of a medicament delivery system according to embodiments of the present invention, showing a cartridge coupled to a reusable injector device;
  • FIG. 2 is a cross-sectional perspective view of the medicament delivery system of FIG. 1;
  • FIG. 3 is a cross-sectional perspective view of the medicament delivery system of FIG. 2 showing the cartridge and a proximal end of the reusable injector device prior to coupling of the cartridge to the reusable injector device, showing the cartridge comprising a needle cover locking mechanism and needle cover in an initial position;
  • FIGS. 4A-C are alternative perspective views of the needle cover locking mechanism shown in FIG. 3;
  • FIG. 5 is a cross-sectional perspective view of the medicament delivery system of FIG. 3 showing the cartridge and a proximal end of the reusable injector device after coupling of the cartridge to the reusable injector device;
  • FIGS. 6A-C are alternative perspective views of the needle cover locking mechanism shown in FIG. 5 interacting with the unlocking element of the reusable injector device;
  • FIG. 7A is a schematic side view of the needle cover locking mechanism and unlocking element of FIG. 5, prior to complete coupling of the cartridge and the reusable injector device;
  • FIG. 7B is a schematic side view of the needle cover locking mechanism and unlocking element of FIG. 7A, after coupling of the cartridge and the reusable injector device is complete;
  • FIG. 8 is a cross-sectional side view of the medicament delivery system of FIG. 5;
  • FIG. 9 is a cross-sectional perspective view of the medicament delivery system of FIG. 5 after the needle cover has been rotated to its primed position by rotation of a cap, showing a needle cover return lock and needle cover locking mechanism;
  • FIG. 10A is a perspective view of a proximal end of a cartridge showing a cap attached to the proximal end of the cassette outer housing, when the needle cover is in its initial state;
  • FIG. 10B is a cross-sectional side view of the proximal end of the cartridge of FIG. 10A, showing the cap attached to the proximal end of the cassette outer housing, when the needle cover is in its initial state;
  • FIG. 10C is a perspective view of the proximal end of the cartridge of FIG. 10A after the cap has been rotated;
  • FIG. 10D is a cross-sectional side view of the proximal end of the cartridge of FIG. 10C, showing the needle cover having been rotated to its primed position in response to rotation by the cap;
  • FIG. 10E is a perspective view of the cap and the proximal end of the cassette outer housing of FIG. 10C, once the cap has been pulled axially away from the cassette outer housing in a proximal direction to uncouple the cap from the cassette outer housing;
  • FIG. 10F is a cross-sectional side view of the cap and the proximal end of the cassette outer housing of FIG. 10C, showing the needle cover in its primed position;
  • FIG. 10G is a perspective view of the proximal end of the cassette outer housing of FIG. 10E, after the cap has been removed from the cassette outer housing to reveal the proximal end of the needle cover;
  • FIG. 10H is a side view of the proximal end of the cassette outer housing and the needle cover of FIG. 10G, showing a cap blocking element formed on the needle cover;
  • FIG. 11A is a perspective view showing the needle cover return lock of FIG. 9 in closer detail
  • FIG. 11 B is a perspective view of the needle cover locking mechanism of FIG. 9 in closer detail;
  • FIG. 110 is an alternative perspective view of the needle cover locking mechanism of FIG. 11B;
  • FIG. 12 is a cross-sectional perspective view of the medicament delivery system of FIG. 9 after the needle cover has been axially translated in a distal direction to its dose delivery position in response to pushing of the needle cover on an injection site;
  • FIG. 13A is a cross-sectional side view of the medicament delivery system of FIG. 12;
  • FIG. 13B is magnified cross-sectional side view of a portion of the medicament delivery system of FIG. 13A, showing a needle cover locking arm in detail;
  • FIG. 14 is a perspective view of a portion of the medicament delivery system of FIG. 12 showing a cassette arm;
  • FIG. 15 is a front view of a portion of the medicament delivery system of FIG. 12 showing a interlock arm of the reusable injector device interacting with the cassette outer housing of the cartridge to couple the cartridge to the reusable injector device;
  • FIG. 16 is a cross-sectional perspective view of the medicament delivery system of FIG. 12 after the plunger rod has been axially translated to dispense a dose of medicament;
  • FIG. 17 is a cross-sectional side view of the medicament delivery system of FIG. 16;
  • FIG. 42 is a flowchart illustrating a method of using a medicament delivery system according to aspects of the present disclosure.
  • FIG. 43 is a flowchart illustrating another method of using a medicament delivery system according to aspects of the present disclosure.
  • the one or more automated functions of an auto-injector may each be activated via an activation mechanism.
  • an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component.
  • Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament.
  • Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.
  • proximal and distal herein respectively refer to as relatively closer to the injection site and relatively further away from the injection site.
  • distal refers to as relatively closer to the injection site and relatively further away from the injection site.
  • square and ramped refer to planar surfaces that extend perpendicular and obliquely to the longitudinal axis of the medicament delivery system 10 (or the cartridge 200 or the reusable injector device 100, where appropriate).
  • lateral refers to being substantially parallel to the longitudinal axis of the medicament delivery system 10 (or the cartridge 200 or the reusable injector device 100, where appropriate).
  • the cartridge 200 is removably couplable to the reusable injector device 100, as shown in FIGS. 41A-E.
  • the cartridge 200 and reusable injector device 100 may be coupled and uncoupled from each other, the cartridge 200 and reusable injector device 100 being combinable for medicament delivery and separable thereafter.
  • FIG. 1 shows the cartridge 200 when coupled to the reusable injector device 100.
  • the cartridge 200 and the reusable injector device 100 each have a respective longitudinal axis that is coaxial with the longitudinal axis X s -X s of the medicament delivery system 10 when the cartridge 200 and the reusable injector device 100 are coupled together as shown in FIG.1 .
  • the cartridge 200 and the reusable injector device 100 may be coupled using any suitable coupling arrangement, including those described throughout this disclosure.
  • the coupling arrangement allows the cartridge 200 and reusable injector device 100 to be uncoupled after a medicament delivery so that the cartridge 200 can be disposed of.
  • the cartridge 200 is a single-use component that can be attached to the reusable injector device 100 to administer a dose of medicament to a patient.
  • the cartridge 200 comprises a cassette outer housing 210, a pre-filled syringe 230, a needle cover 240 and a cap 260, each of which have a generally cylindrical form and are arranged coaxially along the longitudinal axis X s -Xs of the medicament delivery system 10 and the cartridge 200.
  • the pre-filled syringe 230 is received within an internal bore 213 of the cassette outer housing 210 and extends along its length.
  • the pre-filled syringe 230 may be coupled to the cassette outer housing 210 by any suitable holding arrangement such that the prefilled syringe 230 is inhibited from moving axially along longitudinal axis Xs-Xs with respect to the cassette outer housing 210.
  • the holding arrangement may also prevent radial and/or rotational movement of the pre-filled syringe 230 relative to the cassette outer housing 210.
  • the cassette outer housing 210 may have a window 215 through which the pre-filled syringe 230 may be visible to a user, for example so that a user may view the amount of medicament remaining in the pre-filled syringe 230.
  • the cap 260 is coupled to the cassette outer housing 210 and comprises a tubular wall
  • FIG. 1 shows the cap 260 coupled to the proximal end of the cassette outer housing 210, surrounding the proximal end of the needle cover 240.
  • the needle cover 240 is located within the cassette outer housing 240, as described later in more detail with respect to FIG. 2.
  • FIG. 1 shows an aperture 243 formed in the needle cover 240 through which an injection will take place. This aperture 243 would in reality be obscured behind the end wall 262 of the cap 260.
  • the reusable injector device 100 comprises a housing 110 having a generally cylindrical form that contains various components as described later.
  • the reusable injector device 100 is coaxial with the axis Xs-Xs, distal to the cartridge 200.
  • FIG. 2 shows a cross-sectional view of the medicament delivery system 10 of FIG. 1 , showing various components aligned with respect to the axis Xs-Xs.
  • the longitudinal axis of the cartridge 200 and the longitudinal axis of the reusable injector device 100 are coaxial with the axis X s -X s shown in FIG. 2.
  • the pre-filled syringe 230 comprises a cylindrical vial 231 filled with medicament, a bung 232, a needle 233, a rigid needle shield (RNS) 234 and a piston 235.
  • the bung 232 seals the proximal end of the vial 231 and the piston 235 the distal end.
  • the needle 233 extends through the bung 232 and into the vial 231.
  • the piston 235 is configured for proximal displacement through the vial 231 parallel to the axis Xs-Xs during operation of the medicament delivery system 10, to dispense a dose of the medicament through the needle 233 and into an injection site.
  • the needle 233 is enclosed by the optional RNS 234.
  • the RNS 234 is a cylindrical block of protective material with a cavity in which the needle 233 extends.
  • the RNS 234 may be tightly fitted within an internal RNS holder (not shown) of the cap 260 so that the RNS 234 is removed with the cap 260 when the cap 260 is removed from the cassette outer housing 210. The removal of the RNS 234 may be via the aperture 243.
  • the cassette outer housing 210 has a proximal opening 216 at its proximal end for receiving the cap 260 and a distal opening 217 at its distal end for receiving the reusable injector device 100 when the cartridge 200 and reusable injector device 100 are coupled.
  • the pre-filled syringe 230 is held within the internal bore 213 of the cassette outer housing 210 by a pre-filled syringe holder 214, which may be coupled to an inner surface of the cassette outer housing 210 and to the pre-filled syringe 230.
  • the pre-filled syringe holder 214 maintains the pre-filled syringe 230 within a fixed axial and radial position within the cassette outer housing 210.
  • FIG. 2 shows one example form of the pre-filled syringe holder 214 wherein the pre-filled syringe 230 is coupled at a distal end and a proximal end by the pre-filled syringe holder 214, however it should be understood that any other suitable form of a pre-filled syringe holder 214 may be used instead.
  • the pre-filled syringe 230 is arranged within the cassette outer housing 210 such that at least a portion of the proximal end of the needle 233 extends beyond the proximal end of the cassette outer housing 210, through the proximal opening 216 of the cassette outer housing 210. This allows the needle 233 to penetrate an injection site once the cap 260 has been removed from the cartridge 200 and the needle cover 240 has been retracted into the cassette outer housing 210 from a primed position to a dose delivery position, as described later.
  • the needle cover 240 is located within the cassette outer housing 210, extending parallel to the axis Xs-Xs of the medicament delivery system 10 and along most of the axial length of the cassette outer housing 210.
  • the needle cover 240 extends through the internal bore 213, between an inner surface of the cassette outer housing 210 and the pre-filed syringe 230.
  • the tubular wall 261 of the cap 260 comprises a proximal portion 263 arranged to cover the proximal end of the needle cover 240 and a distal portion 264 extending distally from the proximal portion, the distal portion 262 to be received with the proximal end of the cassette outer housing 210.
  • FIG. 2 also shows the reusable injector device 100 in cross-section.
  • the reusable injector device 100 comprises a housing 110, a needle cover shuttle 120 and associated needle cover shuttle spring 121, and a plunger rod 170, each aligned with the longitudinal axis Xs-Xs of the medicament delivery system 10.
  • the reusable injector device 10 may further comprise a plunger rod driving mechanism 180 for driving the plunger rod 170 axially in the proximal direction. Any suitable plunger rod driving mechanism 180 may be used.
  • the housing 110 of the reusable injector device 100 comprises a tubular wall 111 that is open at its proximal end and closed by an end wall (not shown) at its distal end.
  • the outer surface of the tubular wall 111 forms the outer surface of the reusable injector device 100 which is, therefore, cylindrical in appearance.
  • the proximal end of the housing 100 is configured to receive the distal end of the cassette outer housing 210 of the cartridge 200 when the cartridge 200 is coupled to the reusable injector device 100.
  • the housing 110 contains a plunger rod guide sleeve 171 coupled to the tubular wall 111 and used to the plunger rod 170 during axial translation of the plunger rod 170 during dose delivery.
  • the plunger rod guide sleeve 171 comprises a cylindrical channel 174 through which the plunger rod 170 is retained and guided.
  • the cylindrical channel 174 is coaxial with the longitudinal axis X s -X s , allowing the plunger rod 170 to translate through the cylindrical channel 174 along the longitudinal axis Xs-Xs in a proximal direction during dose delivery and an opposite, distal direction during recharging of the plunger rod 170, after dose delivery.
  • a distal surface 173 of the plunger rod guide sleeve 171 may be used to support the distal end of the pre-filled syringe 230 when a cartridge 200 is coupled to the reusable injector device 210.
  • An annular cavity 172 is formed between the outer surface of the plunger rod guide sleeve 171 and the inner surface of the tubular wall 111 , the annular cavity 172 coaxial with the longitudinal axis Xs-Xs.
  • the needle cover shuttle spring 121 is housed within the annular cavity 172.
  • the needle cover shuttle spring 121 is shown in FIG. 2 as a helical coil spring arranged within the annular cavity 172 such that it surround the plunger rod guide sleeve 171 , with the longitudinal axis of the needle cover shuttle spring 121 coaxial with the longitudinal axis X s -Xs of the medicament delivery system 10. It can be seen in FIG.
  • the plunger rod 170, plunger rod guide sleeve 171 , needle cover shuttle spring 121 and tubular wall 111 are all coaxial with the longitudinal axis Xs-Xs of the medicament delivery system 10, with the plunger rod 170 aligned along the axis Xs-Xs, the plunger rod guide sleeve 171 surrounding the plunger rod 171 , the needle cover shuttle spring 121 surrounding the plunger rod guide sleeve 171 , and the tubular wall 111 surrounding the needle cover shuttle spring 121.
  • the needle cover shuttle 120 is received within the housing 110 of the reusable injector device 100, adjacent the proximal end of the housing 110.
  • the needle cover shuttle 120 is configured to translate axially in both proximal and distal directions within the annular cavity 172 of the housing 110, along the axis Xs-Xs.
  • FIG. 2 shows the needle cover shuttle 120 at its most proximal axial position relative to the housing 110.
  • the needle cover shuttle 120 comprises an annular wall 122 and a flange 124, both of which are coaxial with the axis Xs-Xs of the medicament delivery system 10.
  • the flange 124 projects radially outwards from the outer surface of the annular wall 122, at a distal end of the annular wall 122.
  • the flange 124 is located within the annular cavity 172, with the annular wall 122 extending in a proximal direction from the flange 124.
  • the outer surface of the flange 124 may be in abutment with the inner surface of the tubular wall 111 of the housing 110, allowing the tubular wall 111 to act as a guide for the flange 124 and the needle cover shuttle 120 as the needle cover shuttle 120 is translated proximally and distally with respect to the tubular housing 110, along the longitudinal axis Xs-Xs.
  • the annular wall 122 surrounds a proximal end portion of the plunger rod guide sleeve 171 , with the proximal end portion of the plunger rod guide sleeve 171 also acting as a guide for the axial translation of the needle cover shuttle 120.
  • a proximal end of the needle cover shuttle spring 121 abuts the distal surface of the flange 124.
  • the distal end of the needle cover shuttle spring 121 abuts a spring blocking element 123 within the housing 110, which may be formed from a distal portion of the plunger rod guide sleeve 171.
  • the spring blocking element 123 inhibits distal movement of the distal end of the needle cover shuttle spring 121 .
  • the needle cover shuttle spring 121 provides a biasing force to the needle cover shuttle 120 in the proximal direction. In FIG. 2 this is achieved by needle cover shuttle spring 121 being tensioned such that the proximal end of the needle cover shuttle spring 121 engages the distal surface of the flange 124 and biases the flange 124 in the proximal direction.
  • FIG. 2 shows the needle cover shuttle spring 121 in the form of a helical coil spring arranged coaxially about the axis Xs-Xs of the medicament delivery system 10, it should be noted that a different type of biasing means may be used for the needle cover shuttle spring 121 such as a leaf spring, a disc spring, or another type of spring, a resilient material such as rubber, or a means of magnetic repulsion. Furthermore, any suitable arrangement of the biasing means within the housing 110 may be used, as long as the biasing means is able to provide a biasing force to the needle cover shuttle 120 in the proximal direction.
  • a different type of biasing means may be used for the needle cover shuttle spring 121 such as a leaf spring, a disc spring, or another type of spring, a resilient material such as rubber, or a means of magnetic repulsion.
  • any suitable arrangement of the biasing means within the housing 110 may be used, as long as the biasing means is able to provide a biasing force to the needle cover shuttle 120 in the
  • the needle cover 240 once the needle cover 240 has moved to its post-dose delivery position, further axial translation of the needle cover 240 with respect to the cassette outer housing 210 may be inhibited, such as axial translation back in the distal direction.
  • the inhibition may be provided by a needle cover return lock 310 of the cartridge 200.
  • FIG. 3 shows the cartridge 200 of FIG. 2 and a proximal part of the reusable injector device 100 of FIG. 2 pre-use, that is, prior to attachment of the cartridge 200 to the reusable injector device 100.
  • the cartridge 200 is therefore shown to be axially separated from the reusable injector device 100. Only a proximal portion of the reusable injector device 100 is shown, for the sake of clarity.
  • the pre-filled syringe 230 and the majority of the cap 260 of FIG. 2 are also not shown in FIG. 3 so that other features of the cartridge 200 such as the needle cover 240 are not obscured. However, it should be understood that the cap 260 and pre-filled syringe 230 would indeed be present in the cartridge 200.
  • the needle cover 240 is shown in its initial position relative to the cassette outer housing 210 and pre-filled syringe 230, in which the needle cover 240 surrounds the proximal end of the needle 233 and the needle 233 does not extend through the aperture 243 of the needle cover 240, as previously explained in relation to FIG. 2.
  • FIG. 3 shows the cartridge 200 comprising a cartridge coupling feature 700 for coupling to an injector coupling feature 720 of the reusable injector device 100.
  • FIG. 3 shows the cartridge coupling feature 700 comprising a recess 710 formed in the inner surface of the cassette outer housing 210, near the proximal end of the cassette outer housing 210.
  • FIG. 3 shows the injector coupling feature 720 comprising an interlock arm 722, which may engage the recess 710 formed in the inner surface of the cassette outer housing 210 to couple the cartridge 200 with the reusable injector device 100.
  • FIG. 3 has two interlock arms 722, one located each side of the plunger rod 170, and each arranged to engage a corresponding recess 710 formed in the cassette outer housing 210, however the second interlock arm 722 and second recess 710 are not visible in the cutaway view of FIG. 3.
  • FIG. 3 also shows the plunger rod 170 having a recess 730 formed in its outer circumferential surface at a proximal end, and a resilient element 727 for supporting and biasing the interlock arm 720. Operation of the interlock arm 722, recess 730 and resilient element 727 will be described later in more detail.
  • the needle cover 240 Prior to attachment of the cartridge 200 to the reusable injector device 100, the needle cover 240 may be held in this initial extended position by a needle cover locking mechanism 250, as described previously.
  • the needle cover locking 250 mechanism inhibits axial translation of the needle cover 240 relative to the cassette outer housing 210 and the pre-filled syringe 230 when the needle cover 240 is in its initial position shown in FIG. 3 and the cartridge 200 is not yet coupled to the reusable injector device 100.
  • the needle cover locking mechanism 250 also inhibits rotational movement of the needle cover 240 relative to the cassette outer housing 210 and the pre-filled syringe 230 about the longitudinal axis of the cartridge 200.
  • the needle cover locking mechanism 250 is configured to engage with the unlocking element 350 provided in the reusable injector device 100 when the cartridge 200 is coupled to the reusable injector device 100 to allow for rotation of the needle cover 240. In other words, rotation of the needle cover is no longer be inhibited by the needle cover locking mechanism 250 when the cartridge 200 is coupled to the reusable injector device 100 and the needle cover locking mechanism 250 is engaged with the unlocking element 350, as described later in relation to FIG. 5.
  • FIGS. 4A-C show the needle cover locking mechanism 250 of FIG. 3 in more detail, from three different angles.
  • the needle cover locking mechanism 250 comprises a clip 251 and first to third cutouts 501 , 502, 503 formed at a distal end of the needle cover 240.
  • the clip 251 is formed on an internal surface of the cassette outer housing 210, extending from the internal surface of the cassette outer housing 210 in an inward radial direction.
  • the third cutout 503 extends from the inner to outer surface of the needle cover 240 so that the clip 251 can pass through the third cutout 503.
  • the first cutout 501 and the second cutout 502 are also shown as extending fully through the needle cover 240 from its inner to outer surface, however it should be noted in some circumstances that at least one of the first cutout 501 and the second cutout 502 may instead be formed as a recess in the inner surface of the needle cover, without extending fully through the needle cover 240.
  • the clip 251 is arranged at the distal end of the cassette outer housing 210.
  • the clip 251 comprises a first portion 252 that extends from the inner surface of the cassette outer housing 210 in a direction substantially normal to the inner surface of the cassette outer housing 210 and towards the longitudinal axis of the cartridge 200.
  • the clip 251 further comprises a second portion 253 coupled to the first portion 252 that extends substantially parallel to the longitudinal axis of the cartridge 200, in a distal direction from the first portion 252, substantially parallel to the longitudinal axis of the cartridge 200.
  • the second portion 253 is arranged to extend from the first portion 252 so that a portion of the needle cover 240 is accommodated between the second portion 253 and the inner surface of the cassette outer housing 210, as shown in FIG. 3 and FIGS.
  • the second portion 251 may have an arm-like form.
  • the second portion 253 of the clip 251 terminates at its distal end in a retaining block 254, which extends towards the inner surface of the cassette outer housing 210 in a radial direction away from the axis of the cartridge 200.
  • the retaining block 254 comprises a square proximal surface 255 and a ramped distal surface 256.
  • the square proximal surface 255 is located in a space between the second portion 252 and the inner surface of the cassette outer housing 210.
  • the ramped distal surface 256 faces towards the inner surface of the cassette outer housing 210, away from the axis of the cartridge 200.
  • the first cutout 501 and the second cutout 502 are generally rectangular in shape and are located adjacent to each other at the distal end of the needle cover 240.
  • the first cutout 501 and the second cutout 502 are arranged circumferentially around the inner surface of the needle cover 240 such that a rotation of the needle cover 240 from its initial position to its primed position about the axis of the cartridge would cause the second cutout 502 to move into a position previously occupied by the first cutout 501 prior to the rotation.
  • the first cutout and the second cutout are separated by a crossbar 505 extending from a proximal to distal direction.
  • the third cutout 503 is generally ‘L-shaped’ and is located proximal in the needle cover 240 compared to the first cutout 501 and the second cutout 502, nearer the proximal end of the needle cover 240.
  • the retaining block 254 is dimensioned to be of a similar cross-sectional shape as the first cutout 501 , such that the lateral sides of the retaining block 254 are in abutment with, or near abutment with, the lateral walls of the first cutout 501. Rotation of the needle cover 240 in one direction (i.e. anti-clockwise when viewing the cartridge 200 of FIG.
  • the clip 251 is able to resiliently deform such that the retaining block 504 can be removed from the first cutout 501 by pivoting the second portion 253 about the first portion 252, in a direction away from the first cutout 501 and towards the axis of the cartridge 200. However, the clip 251 is biased to pivot the retaining block 504 away from the axis of the cartridge, towards the cassette outer housing 210 and into the first cutout 501.
  • the cap 260 (mostly hidden in FIG. 3 for visual clarity) comprises a blocking element 266 that projects radially inwards from the inner surface of the tubular wall 261 of the cap 260, for example the distal portion 264 of the tubular wall 261 , towards the axis of the cartridge 200.
  • the blocking element 266 is used for causing the needle cover 240 to rotate about the axis of the cartridge 200.
  • the cap 260 may be coupled to the cassette outer housing 210 such that removal of the cap 260 from the cassette outer housing 210 requires rotation of the needle cover 240 from its initial position to its primed position using the blocking element 266.
  • the blocking element 266 of the cap 260 abuts a portion of the needle cover 240 such as the side surface 244 of the needle cover 240 when the needle cover 240 is in its initial position. Since the needle cover 240 is inhibited from rotating due to the needle cover locking mechanism 250, the blocking element 266 is prevented by abutment with the needle cover 240 from moving circumferentially around the axis of the cartridge 200 to rotate the needle cover 240. As a result, rotation of the cap 260 is also inhibited by the needle cover 240.
  • the cartridge 200 must be coupled to the reusable injector device 100 as later described in relation to FIG. 5.
  • the needle cover locking mechanism 250 therefore prevents removal of the cap 260 from the remainder of the cartridge 200 until the cartridge 200 has been coupled to the reusable injector device 100, improving safety of the cartridge 200.
  • a user has pushed the distal end of the cartridge 200 into the proximal end of the reusable injector device 100 so that the cartridge 200 and reusable injector device 100 become coupled.
  • the cartridge 200 and reusable injector device 100 may be coupled by any suitable coupling feature, for example by a friction fit, one or more clips, corresponding ridges and grooves, a bayonet coupling, a threaded coupling, a push fit, or the like.
  • Example coupling features are described later in relation to FIGS. 35A-C, FIG. 36 and FIG. 37 for example.
  • FIG. 7A is a schematic side view of a portion of the cartridge 200 and reusable injector device 100 of FIG. 5, as the cartridge 200 is being coupled to the reusable injector device 100.
  • FIG. 7A shows the first portion 252 of the clip 251 extending through the third cutout 503 in the needle cover 240.
  • the second portion 253 of the clip 251 extends axially towards, and in alignment with, the unlocking element 350 of the reusable injector device 100.
  • the unlocking element 350 may be formed from a material having a lesser resilience (greater rigidity) than the clip 251 so as to reduce radial deflection of the unlocking element 350 as the cartridge 200 is coupled to the reusable injector device 100.
  • the distal end surface of the cassette outer housing 210 is now in abutment with a proximal surface of the housing 110 of the reusable injector device 100, inhibiting further movement of the cassette outer housing 210 towards the reusable injector device 100.
  • the cartridge 200 and reusable injector device 100 are now fully coupled.
  • FIGS. 6B and 6C show the interaction between the clip 251 and the unlocking element 350 of FIG. 6A from alternative viewing angles.
  • the lifting of the clip 251 out of the first cutout 501 by the unlocking element 350 may in some examples only require a relatively small movement of the clip 251.
  • axial movement of the needle cover 240 in a proximal to distal direction remains inhibited due to the engagement between the clip 251 and the third cutout 503. More specifically, axial movement of the needle cover 240 in a proximal to distal direction relative to the cassette outer housing 110 remains inhibited due to abutment between a first proximal wall of the third cutout 503 and a proximal surface of the first portion 252 of the clip 251.
  • the needle cover locking arm 610 also remains engaged with the upper surface of the cassette arm, 615 inhibiting pivoting of the needle cover locking arm 610 towards the cassette outer housing 210.
  • the distal end surface of the needle cover 240 engages with the proximal end surface of the annular wall 122 of the needle cover shuttle 120.
  • the needle cover shuttle spring 121 applies a biasing force to the needle cover shuttle 120 in the proximal direction such that the needle cover shuttle 120 in turn makes contact with, and applies a force to, the distal end surface of the needle cover 240, ensuring the needle cover 240 is biased in the proximal direction.
  • FIG. 8 shows a cross-sectional side view of the cartridge 200 and reusable injector device 100 of FIG. 5.
  • FIG. 8 shows the presence of an additional clip 25T that can perform the same function as the original clip 251.
  • FIG. 8 also shows a locking recess 617 formed in the inner surface of the cassette outer housing 210, at a distal end of the cassette outer housing 210.
  • the locking recess 617 may take the form of an aperture extending from the inner surface to outer surface of the cassette outer housing 210.
  • the locking recess 617 is located adjacent the cassette arm 615 and is configured to retain the locking element 612 of the needle cover locking arm 610 to inhibit axial translation of the needle cover 240 after the needle cover 240 has moved into its post-dose delivery position.
  • FIG. 9 shows the cartridge 200 and reusable injector device 100 of FIG. 5 during a subsequent cap removal step, in which the needle cover 240 is rotated from its initial position to its primed position.
  • the clip 251 has been lifted by the unlocking element 350 as previously described in relation to FIG. 5 and therefore the needle cover 240 is now free to rotate about the axis of the cartridge 200.
  • FIG. 9 shows the cartridge 200 after this rotation of the needle cover 240 has taken place.
  • the cap 260 must first be rotated with respect to the cassette outer housing 210 about the axis Xs-Xs before being axially removed from the cassette outer housing 210.
  • FIG. 9 shows the cap 260 after being rotated but not axially removed.
  • the needle cover 240 may be rotated by a user gripping and rotating the cap 260 about the axis of the cartridge 200.
  • the blocking element 266 of the cap 260 is brought into abutment with, and applies a force to, the side surface 244 of the needle cover 240. Since the clip 251 is no longer held in the first cutout 501, the force applied by the blocking element 266 causes the needle cover 240 to rotate about the axis of the cartridge 200 in unison with the blocking element 266 and cap 260.
  • Rotation of the needle cover 240 is guided by the first portion 252 of the clip 251 traversing through the third cutout 503 in a channel between the distal wall of the third cutout 503 and the first proximal wall of the third cutout 503.
  • Rotation of the cap 260 and the needle cover 240 may continue until the first portion 252 of the clip 251 is brought into abutment with a side wall of the third cutout 503, at which stage the first portion 252 of the clip 251 is now in alignment with a portion of the third cutout 503 having second proximal wall further in the proximal direction than the first proximal wall of the third cutout 503.
  • the second cutout 502 of the needle cover 240 will now be located between the retaining block 254 of the clip 251 and the inner surface of the cassette outer body 210, however the clip 251 remains distended away from the second cutout 502 by continued engagement with the unlocking element 350.
  • the cap 260 may then be removed from the remainder of the cartridge 200 by pulling the cap 200 in a distal to proximal direction.
  • FIGS. 10A-H are used to illustrate removal of the cap 260 from the cassette outer housing 210 in greater detail, in accordance with embodiments of the present disclosure.
  • the cap 260 comprises a guide pin 267 that projects radially outwards from the outer surface of the tubular wall 261 of the cap 260, for example from the distal portion 264 of the tubular wall 261.
  • the guide pin 267 is arranged to be received in a track 270 formed at the inner surface of the cassette outer housing 210, at a proximal end of the cassette outer housing 210.
  • the track 270 is configured to guide the guide pin 267 along the track 270, and may comprise a groove formed in the inner surface of the cassette outer housing 210.
  • the track 270 may be L-shaped, having a first track portion 271 extending circumferentially around the inner surface of the cassette outer housing 210, perpendicular to the longitudinal axis of the cartridge 200.
  • FIG. 10B shows the same cartridge 200 as FIG. 10A, but viewed from the opposite side of the cartridge 200 to show the position of the needle sleeve 240.
  • the cartridge 200 shown in FIG. 10A and FIG. 10B may correspond to the cartridge shown in FIG. 5, that is, before the cap 260 has been rotated and the needle sleeve 240 is in its initial position.
  • FIG. 10A shows the guide pin 267 received within the first track portion 271 while FIG.
  • FIG. 10B shows the blocking element 266 of the cap in abutment with the side surface 244 of the needle cover 240.
  • the cap 260 cannot be axially removed from the cassette outer housing 210 due to the presence of the guide pin 267 in the first track portion.
  • the cap 260 must first be rotated then axially translated to remove it from the cassette outer housing 210.
  • a rotation of the cap 260 by a user about the axis of the cartridge 200 relative to the cassette outer housing 210 will cause the guide pin 267 to traverse the first portion 271 of the track 270 until it abuts a terminal wall of the first portion 271 , preventing further rotation of the cap 260.
  • FIG. 10C This rotational movement of the cap 260 along the first track portion 271 is shown in FIG. 10C and is used to rotate the needle sleeve 240 from its initial position to its primed position.
  • FIG. 10D is a view of the cartridge 200 shown in FIG. 10C from the opposite side of the cartridge 200 to show the position of the needle sleeve 240 now in its primed position, having been rotated by the blocking element 266.
  • the guide pin 267 When the guide pin 267 abuts the terminal wall of the first track portion 271, it will now be aligned with a second track portion 272, which extends axially in a proximal direction along the inner surface of the cassette outer housing 210 to the proximal end of the cassette outer housing 210, at which point the second track portion 272 has an open end. Therefore, once the guide pin 267 is aligned with the second track portion 272, the user may pull the cap 260 in a distal to proximal axial direction relative to the cassette outer housing 210 as shown in FIG.
  • FIG. 10F is a view of the cartridge 200 shown in FIG. 10E from the opposite side of the cartridge 200 to show that the needle sleeve 240 remains in its primed position, but the blocking element 266 is no longer visible, having been proximally removed from within the cassette outer housing 210.
  • the cap 260 may now be fully uncoupled from the cassette outer housing 210 and can be fully removed, as illustrated in FIG. 10G.
  • FIG. 10H shows the needle cover 2440 comprising an optional detent 275 formed on its outer surface to inhibit recoupling of the cap 260 to the cassette outer housing 210 once the cap 260 has been removed.
  • the detent 275 may be located on the tubular wall 241 of the needle cover 240, adjacent the distal end of the cassette outer housing 210.
  • the detent 275 may comprise a distal ramped surface 276 and a proximal square surface 277, arranged such that the blocking projection 266 of the cap 260 can pass over the ramped surface 276 as the cap 260 is removed from the cassette outer housing 210, however replacement of the cap 260 will be inhibited by engagement between the blocking projection 266 and the square surface 277.
  • the detent 275 may instead be formed on the inner surface of the cassette outer housing 210.
  • a rotational stop element 280 may inhibit the needle cover 240 from rotating back in the opposite direction, out of the primed position towards the initial position.
  • the rotational stop element 280 may be arranged such that it is brought into non-returnable abutment with a feature of the needle cover 240 once the needle cover 240 has been rotated to its primed position. As an example illustrated in FIG.
  • the rotational stop element 280 may comprise an arm 281 extending from the inner surface of the cassette outer housing 210 perpendicular to the longitudinal axis of the cartridge 200, the arm 281 having a stop projection 282 configured to engage with the side surface 244 of the needle sleeve 240 once the needle sleeve 240 has been rotated to its primed position.
  • the arm 281 may be biased to pivot towards the needle cover 240. The biasing may be provided by the arm
  • FIGS. 31A-D show an alternative mechanism for preventing axial translation of the needle sleeve 240 using a movable ramp 820.
  • a raised platform 840 is formed on the inner surface of the cassette outer housing 210, with a proximal edge of the platform 840 forming a shoulder 380 with another portion of the cassette outer housing 210.
  • the movable ramp 820 is positioned adjacent the inner surface of the cassette outer housing 210 such that a square surface 822 of the movable ramp 820 abuts the shoulder 830. A portion of the square surface 822 extends beyond the shoulder 830 of the platform 840.
  • a ramped surface 821 of the movable ramp 820 is angled away from the inner surface of the cassette outer housing 210 and in a proximal direction.
  • a needle cover catch 810 forming part of the needle cover 240 extends distally within the cassette outer housing 210, having a ramped surface 811 and a square surface 812.
  • the ramped surface 811 of the needle cover catch 810 abuts the ramped surface 821 of the movable ramp 820.
  • the square surface 812 of the needle cover catch 810 is located proximally adjacent to the ramped surface 811, facing a proximal direction.
  • the needle cover catch 810 is resiliently biased towards the cassette outer housing 210.
  • the positions of the movable ramp 820 and needle cover catch 810 shown in FIG. 31A correspond to the primed position of the needle cover 240 described previously.
  • the needle cover catch 810 As the needle cover 240 is axially translated in a distal direction from its primed position to its dose delivery position, the needle cover catch 810 also axially translated, as shown in FIG. 31 B. In doing so, the needle cover catch 810 moves distally over the movable ramp 820, with the ramped surface 811 of the needle cover catch 810 sliding over the ramped surface 821 of the movable ramp 820 until the square surface 812 of the needle cover catch 810 has moved distally beyond the square surface 822 of the movable ramp 820 and the distal end of the needle cover catch 810 contacts the platform 840 (due to the resilient bias towards the cassette outer housing 210).
  • FIG. 31 C shows the state of the movable ramp 820 and the needle cover catch 810 after the needle cover 240 has moved from its dose delivery position towards its post-dose delivery position.
  • the needle cover catch 810 has now moved proximally with respect to the cassette outer housing 210, maintaining engagement with the platform 840, until the quare surface 812 of the needle cover catch 810 engages with the portion of the square surface 822 of the movable ramp 820 that extends beyond the inner surface of the platform 840, causing the movable ramp 820 to translate proximally with the needle cover catch 810.
  • the first potion 851 of the track 850 may be inclined slightly around the circumference of the cassette outer housing 210 such that, as the pin 802 traverses the first portion 851, the needled cover 240 is slightly rotated. As the needle cover 240 is allowed to translate back in a proximal direction from its dose delivery to its post-dose delivery state, the pin 802 now traverses a second portion 853 of the track 850 (due to the previous slight rotation of the needle sleeve 240) until the pin 802 is received in a holding portion 854 of the track 851.
  • the holding potion 854 is shaped to prevent the needle sleeve 240 from once again translating in a distal direction.
  • cap 260 is attached to the cassette outer housing 210 through a bayonet-type coupling, where the cap 260 must first be rotated with respect to the cassette outer housing 210 before being axially removed from the remainder of the cartridge 200.
  • alternative mechanisms for coupling the cap 260 to the cassette outer housing 210 may be envisaged.
  • the needle cover has a ramped side surface configured to interact with the projection of the cap.
  • the cap is arranged to follow a linear groove in the cassette outer housing arranged parallel to the axis of the cartridge as the cap is pulled away from the cartridge in a linear distal to proximal direction.
  • the projection abuts the ramp of the needle cover, causing the needle cover to rotate as the projection slides along the ramp, until the projection is able to leave the proximal end of the groove and the cap can be fully separated from the remainder of the cartridge.
  • This embodiment may provide a simple mechanism for removing the cap that only requires a ‘pulling’ motion by the user on the cap.
  • FIGS. 35A-C, FIG. 36 and FIG. 37 show different mechanisms for coupling the cartridge 200 to the reusable injector device 100.
  • FIG. 35A shows two recesses 710, 710’ formed in the inner surface of the cassette outer housing 210.
  • the two recesses 710, 710’ are located at the distal end of the cassette outer housing 210, in a portion of the cassette outer housing 210 that is received in the housing 110 of the reusable injector device 100.
  • the recesses 710, 710’ are located opposite each other in the cassette outer housing 210, either side of the longitudinal axis of the cartridge 200.
  • the recesses 710, 710’ each extend in a circumferential direction around the inner surface of the cassette outer housing 210 and are each dimensioned to receive an end of a corresponding interlock arm 722’, 722’, as described previously in relation to FIG. 15. As shown in FIG.
  • each interlock arm 722, 722’ are configured to extend into the respective recesses 710, 710’ in the cassette outer housing 210 by a relatively small distance when the cartridge 200 is initially inserted into the reusable injector device 100, thereby coupling the cartridge 200 to the reusable injector device 100.
  • the interlock arms 722, 722’ extending only a relatively small distance into each respective recess 710, 710’, it may require only a relatively small axial force to be applied by the user to the cartridge 200 to couple the cartridge 200 to the reusable injector device 100 or remove the cartridge 200 from the reusable injector device 100.
  • the bayonet pins 381 are arranged such that they can each be distally inserted into a corresponding L-shaped bayonet groove 382 formed in the inner surface of the proximal end of the housing 110 of the reusable injector device 100.
  • Each bayonet groove 382 has a first elongate portion extending distally from the proximal face of the housing 110 and a second elongate portion extending from the distal end of respective first portion, in a circumferential direction perpendicular to the axis of the reusable injector device 100.
  • the user performs the aforementioned actions in reverse.
  • FIGS. 38A-B illustrate an example operation of the interlock arms 722, 722’ in more detail.
  • FIGS. 38A-B show a distal end of a cartridge 200, including distal ends of the cassette outer housing 210 and needle cover 240.
  • FIGS. 38A-B also show a proximal end of the reusable injector device 100.
  • the cartridge 200 and reusable injector device 100 may be any suitable cartridge 200 and reusable injector device 100 described herein. Certain features such as the pre-filled syringe 230 have been excluded from FIGS. 38A-B for clarity.
  • FIG. 38A shows the cartridge 200 coupled to the reusable injector device 100, after a user has axially inserted the distal end of the cassette outer housing 210 into the proximal end of the housing 110 of the reusable injector device 100.
  • the cartridge 200 and reusable injector device 100 may be identical to the cartridge 200 and reusable injector device 100 previously described in relation to FIG. 12 and FIG. 15.
  • FIG. 38A shows the reusable injector device 100 comprising two interlock arms 722, 722’ arranged radially with respect to the longitudinal axis Xs-Xs of the reusable injector device 100, one either side of the plunger rod 170.
  • the plunger rod 170 may be cylindrical and is generally of a constant diameter D 2 along its length, as shown in FIG. 38B. However, the plunger rod 170 has at least one recess 730 formed at a proximal end of the plunger rod 170, in the outer circumferential surface of the plunger rod 170, as shown in FIG. 38A, wherein the plunger rod 170 has a diameter Di at the at least one recess 730 that is less than the diameter D 2 .
  • the at least one recess 730 is arranged to accommodate an inner end 728, 728’ of each interlock arm 722, 722’.
  • the at least one recess 730 may comprise an annular groove around the circumference of the plunger rod 170, wherein the annular groove may be able to accommodate one or more of the interlock arms 722, 722’.
  • the at least one recess 730 may comprise a plurality of recesses 730 spaced circumferentially around the plunger rod 170, each recess 730 configured to receive at least one corresponding interlock arm 710.
  • FIG. 38A shows the plunger rod 170 further comprising the optional plunger projection 177.
  • Each interlock arm 722, 722’ is biased in a neutral radial position by a respective resilient element 727, 727’, as described previously in relation to FIG. 15, such that a portion of the outer end 724, 724’ of each interlock arm 722, 722’ is received in its respective recess 710, 710 in the cassette outer housing 210 and a portion of the inner end 728, 728’ of each interlock arm 722, 722’ is received in the recess 730 (or respective recesses 730) in the cassette outer housing 210.
  • the cartridge 200 is therefore coupled to the reusable injector device 100, however the cartridge 200 may easily be uncoupled and recoupled by moving the cartridge 200 proximally or distally with respect to the reusable injector device 100, as indicated by the arrows labelled ‘A’.
  • FIG. 38B shows the cartridge 200 and reusable injector device 100 of FIG. 38A after the plunger rod 170 has been axially translated during a dose dispense operation, for example as previously described in relation to FIG. 20 and FIG. 24.
  • the plunger rod 170 is moved along the axis Xs-Xs of the reusable injector device 100 in a distal to proximal direction
  • the at least one recess 730 formed in the plunger rod 170 also moves axially with respect to the interlock arms 722, 722’.
  • a distal inner surface of each recess 730 will be brought into abutment with a ramped surface 723, 723’ of a corresponding interlock arm 722, 722’.
  • each interlock arm 722, 722’ As the interlock arms 722, 722’ each move in opposing radial directions away from the plunger rod 170, the outer ends 724, 724’ of each interlock arm 722, 722’ are moved further into the corresponding one or more recesses 710, 710’ formed in the cassette outer housing 210, each interlock arm 722, 722’ and corresponding recess 710, 710’ in the cassette outer body 210 together acting as a detent to inhibit axial separation of the cartridge 200 from the reusable injector device 100.
  • the inner ends 728, 728’ of each interlock arm 722, 722’ now abut the circumferential outer surface of the plunger rod 170.
  • the interlock arms are therefore prevented by the circumferential outer surface of the plunger rod 170 from moving in the opposite radial direction, back towards the plunger rod 170 and the longitudinal axis Xs-Xs of the reusable injector device 100.
  • the interlock arms722, 722’ therefore inhibit removal of the cartridge 200 from the reusable injector device 100 for as long as the plunger rod 170 is not in its retracted position (shown in FIG. 38A).
  • the plunger rod 170 is axially translated by any suitable mechanism from its extended position shown in FIG. 38B to its retracted position shown in FIG. 38A.
  • the interlock arms 722, 722’ will each move in a radial direction back towards the plunger rod 170 and the longitudinal axis X s -X s of the reusable injector device 100 so that the inner ends 728, 728’ of each interlock arm 722, 722’ are accommodated within the corresponding at least one recess 730 formed on the plunger rod 170 and the outer ends 724, 724’ of each interlock arm 722, 722’ are at least partially removed from the corresponding at least one recess 710, 710’ formed in the cassette outer housing 210.
  • FIGS. 39 and 40A-C are used to illustrate some of the indicators that can be provided as part of a cartridge 200 according to embodiments of the present disclosure.
  • FIG. 39 is a side view of a medicament delivery system 10 according to embodiments of the present invention.
  • FIG. 39 shows a cartridge 200 coupled to a reusable injector device 100, which may be any cartridge 200 and reusable injector device 100 disclosed herein. Only a proximal portion of the reusable injector device 100 is shown, with the remainder of the reusable injector device 100 not shown.
  • the cartridge 200 comprises a coupling indication feature 430 for indicating to a user whether the cartridge 200 has been correctly coupled to the reusable injector device 100.
  • the coupling indication feature 430 may comprise a visual indicator provided on the outer surface of the cassette outer housing 210, at a distal end of the cassette outer housing 210.
  • the visual indicator is positioned on the cassette outer housing 210 such that it can indicate whether the cartridge 200 has been correctly coupled to the reusable injector device 100.
  • the visual indicator may comprise a coloured or marked portion of the outer surface of the cassette outer housing 210 that has a different colour or marking to the remainder of the cassette outer housing 210.
  • the location of the visual indicator relative to the reusable injector device 100 may be indicative of whether the cartridge 200 has been correctly coupled to the reusable injector device 100.
  • the visual indicator may be positioned on the cassette outer housing 210 such that it is fully (or partially) obscured by the housing 110 of the reusable injector device 100 when the cartridge 200 has been correctly coupled to the reusable injector device 100, but is not fully (or partially) obscured by the housing 110 of the reusable injector device 100 if the cartridge 200 has been incorrectly correctly coupled to the reusable injector device 100.
  • FIG. 39 shows the coupling indication feature 430 comprising a first visual indicator 431 and a second visual indicator 432, the first visual indicator 431 and the second visual indicator 432 each comprising a respective band around the outer surface of the cassette outer housing, at a distal end of the cassette outer housing 210.
  • the first visual indicator 431 has a different colour, marking or texture to the second visual indicator 432.
  • the first visual indicator 431 is located adjacent and proximal to the second visual indicator 432.
  • the first visual indicator 431 and the second visual indicator 432 are located on the cassette outer housing 210 such that the second visual indicator 432 is obscured by the proximal end of the housing 110 of the reusable injector device 100 when the cartridge is correctly coupled to the reusable injector device 100, but is visible when the cartridge is not correctly coupled to the reusable injector device 100.
  • FIG. 39 shows the cartridge 200 may comprise a cartridge ready indicator 410, for indicating whether the cartridge 200 is ready for an injection to be performed (i.e. the needle cover 240 is in its primed position).
  • the cartridge ready indicator 410 may have a first visual state for indicating that the cartridge 200 is not ready for an injection and a second visual state for indicating that the cartridge 200 is ready for an injection.
  • FIG. 39 shows the cartridge ready indicator 410 comprising an aperture 404 located in the cassette outer housing 210.
  • the aperture 404 may be located such that, when the needle cover 240 is in its initial position, the needle cover 240 is not visible through the aperture 404, which corresponds to the first visual state of the cartridge ready indicator 410.
  • the aperture 404 may also be located such that, when the needle cover 240 is rotated to its primed position, the needle cover 240 is now visible through the aperture 404, which corresponds to the second visual state of the cartridge ready indicator 410.
  • FIG. 39 shows the cartridge 200 may comprise a cartridge used indicator 420, for indicating whether the cartridge 200 has already been used to dispense a dose of medicament (i.e. the needle cover 240 is in its post-dose delivery position).
  • the cartridge used indicator 420 may have a first visual state for indicating that the cartridge 200 has not already been used to dispense a dose of medicament and a second visual state for indicating that the cartridge 200 has been used to dispense a dose of medicament.
  • FIG. 39 shows the cartridge used indicator 420 comprising an aperture 421 located in the cassette outer housing 210.
  • the locking recess 617 of the cartridge 200 may form the aperture 421 of the cartridge used indicator 420, with the locking element 612 becoming visible through the aperture 421 once the needle cover 240 has moved to its post-dose delivery position.
  • the first state of the cartridge used indicator 420 may correspond to the locking element 612 not being visible through the aperture 421 while the second state of the cartridge used indicator 420 may correspond to the locking element 612 being visible through the aperture 421.
  • FIGS. 40A-C show an example of a cartridge 200 in accordance with embodiments of the present invention, wherein the cartridge 200 has the indicators previously described in relation to FIG. 39.
  • FIG. 40A shows a cartridge 200 before it has been coupled to a reusable injector device 100, where the cap 260 is coupled to the cassette outer housing 210 and the needle cover 240 is in its initial position.
  • the cartridge ready indicator 410 is therefore in a state that indicates to a user that the cartridge 200 has not been primed by moving the needle cover 240 from its initial position to its primed position.
  • the needle cover 240 may not be visible through the aperture 404 of the cartridge ready indicator 410.
  • the cartridge used indicator 420 is in a state that indicates to a user that the needle cover 240 is not in its post-delivery state and therefore that the cartridge 200 has not yet been used for delivery of a dose of medicament.
  • the locking element 612 may not be visible through the aperture 421 of the cartridge used indicator 420.
  • FIG. 40B shows the cartridge 200 of FIG. 40A, after it has been coupled to a reusable injector device 100 and the cap 260 has been removed.
  • the reusable injector device 100 is not shown, for clarity.
  • the needle cover 240 has been rotated from its initial position to its primed position, for example in response to removal of the cap 260.
  • the cartridge ready indicator 410 is therefore now in a state that indicates to a user that the cartridge 200 is primed and ready for an injection.
  • the needle cover 240 may now be visible through the aperture 404 of the cartridge ready indicator 410.
  • the cartridge used indicator 420 is still in a state that indicates to a user that the needle cover 240 is not in its post-delivery state and therefore that the cartridge 200 has not yet been used for delivery of a dose of medicament.
  • FIG. 40C shows the cartridge 200 of FIG. 40B, after an injection has taken place by pressing the needle cover 240 against an injection site and delivering a dose of medicament.
  • the cartridge used indicator 420 is now in a state that indicates to a user that the needle cover is in its post-delivery state and therefore that the cartridge 200 has been used for delivery of a dose of medicament.
  • the locking element 612 may now be visible through the aperture 421 of the cartridge used indicator 420.
  • FIGS. 41A-E show an example of a medicament delivery system 10 in accordance with embodiments of the present invention, demonstrating the use of the medicament delivery system 10 to administer an injection.
  • FIG. 41 A shows the cartridge 200 and the reusable injector device 100 of the medicament delivery system 10 in a separated state, prior to being used for an injection.
  • This state may be similar to the state described previously in relation to FIG. 3.
  • the cap 260 is shown coupled to the cassette outer housing 210 and so a user is protected from the needle 233 inside the cartridge 200.
  • the needle cover 240 will be in its initial position and inhibited from rotating due to the needle cover locking mechanism 250. Since the needle cover 240 cannot be rotated, the cap 260 cannot be removed from the cassette outer housing 210.
  • the cartridge ready indicator 410 is indicating that the cartridge 200 has not yet been primed for an injection.
  • the cartridge used indicator 420 is in a state that indicates that the cartridge 200 has not yet been used for delivery of a dose of medicament.
  • FIG. 41 B shows the medicament delivery system 10 of FIG. 41 A, after the cartridge 200 has been coupled to the reusable injector device 100.
  • Such coupling may be achieved by a user inserting the distal end of the cartridge 200 into the proximal end of the reusable injector device 100, in a proximal to distal direction along the longitudinal axis of the reusable injector device 100.
  • the cartridge 200 may be coupled to the reusable injector device 100 by any suitable means described previously, such as a friction fit, push fit, threaded connection, bayonet connection, or the like.
  • This state of the medicament delivery system 10 may be similar to the state described previously in relation to FIG. 5. In this state, the cap 260 remains attached to the cartridge 200, protecting the user from the needle 233.
  • the needle cover 240 has not yet been rotated as previously described in relation to FIG. 9. This is evident from the cartridge ready indicator 410 still not indicating that the cartridge 200 has been primed for an injection.
  • the cartridge used indicator 420 is still in a state that indicates that the cartridge 200 has not yet been used for delivery of a dose of medicament.
  • the user may still be possible for the user to uncouple the cartridge 200 from the reusable injector device 100, if required.
  • Axial movement of the needle cover 240 with respect to the cassette outer housing 210 is inhibited as previously described, however rotation of the needle cover 240 is now possible due to engagement between the needle cover locking mechanism 250 of the cartridge 200 and the unlocking element 350 of the reusable injector device 100, therefore it is possible to remove the cap 260.
  • FIG. 41 C shows the medicament delivery system 10 of FIG. 41 D in a state ready for an injection, which may be similar to the state described previously in relation to FIG. 9.
  • the user has now removed the cap 260 from the remainder of the cartridge 200 by rotating the cap 260 relative to the cassette outer housing 210 and reusable injector device 100, as described previously. Such a rotation has also caused the needle cover 240 within the cassette outer housing 210 to rotate, moving the needle cover 240 from its initial position to its primed position and placing the medicament delivery system 10 in a primed state.
  • the cap 260 can now be fully separated from the cassette outer housing 210 by pulling it in a distal to proximal direction.
  • Removal of the cap 260 now leaves a proximal end of the needle cover 240 extending through the proximal end of the cassette outer housing 210, however the needle 233 remains protected within the needle cover 240.
  • Rotation of the needle cover 240 has caused the cartridge ready indicator 410 to move to its new state indicating that the cartridge 200 has been primed for an injection. Once the needle cover 240 has been rotated into its primed position, rotation back in the opposite direction may be prevented by the rotational stop element 280 as described previously in relation to FIG. 9.
  • Distal axial movement of the needle cover 240 into the cassette outer housing 210 is no longer inhibited at this stage, however the needle cover 240 remains in an extended position covering the needle 233 due to the biasing force provided by the needle cover shuttle 120 and needle cover shuttle spring 121.
  • the cartridge used indicator 420 is still in a state that indicates that the cartridge 200 has not yet been used for delivery of a dose of medicament.
  • FIG. 41 D shows the medicament delivery system 10 of FIG. 41 C during an injection of medicament, which may be similar to the state described previously in relation to FIG. 12.
  • the user has placed the proximal end surface of the needle cover 240 onto the injection site and pushed the reusable injector device 100 and cassette outer housing 210 both towards the injection site.
  • a reaction force between the injection site and the proximal end surface of the needle cover 240 has caused the needle cover 240 to translate into the cassette outer housing 210 along the longitudinal axis of the cartridge 210 in a proximal to distal direction, from its primed position to its dose delivery position.
  • a proximal end of the needle 233 progressively emerges from the proximal end of the needle cover 240 and is inserted into the injection site. If, at this stage, translation of the plunger rod 170 had not yet begun and the user removes the medicament delivery system 10 from the injection site, the needle cover 240 would translate back out of the cassette outer housing 210 along the longitudinal axis of the cartridge 200 in a distal to proximal direction under the force of the needle cover shuttle spring 121 , progressively covering the needle 233 until the needle 233 is no longer exposed.
  • Translation of the plunger rod 170 may, for example, be initiated in response to a detection of the needle sleeve 240 translating at least a threshold distance into the cassette outer housing. In other examples, it may be initiated by a user actuating a trigger button. In other examples the initiation may be automatic, occurring a predetermined period of time after a sensed event, such as connection of the cartridge 200 to the reusable injector device 100, rotation of the cap 260, removal of the cap 260, or axial movement of the needle cover 240.
  • the cartridge ready indicator 410 still indicates that the cartridge 200 has been primed for an injection.
  • the cartridge used indicator 420 has now changed to a state that indicates that the cartridge 200 has been used for delivery of a dose of medicament.
  • the locking element 612 of the needle cover return lock 310 may now be visible through the cartridge used indicator 420, as previously described.
  • the cartridge 200 can be uncoupled from the reusable injector device 100 by moving the cartridge 200 relative to the reusable injector device 100 in a distal to proximal direction along the longitudinal axis of the reusable injector device 100. After the used cartridge 200 and reusable injector device 100 have been separated, the used cartridge 200 can be disposed of and the reusable injector device 100 may be used again with a different cartridge 200.
  • the needle cover 240 of the used cartridge 240 remains inhibited from translating axially into the cassette outer housing by the needle cover return lock 310 and therefore the needle 233 cannot be exposed by accidental movement of the needle cover 240.
  • a dose of medicament is delivered using the medicament delivery system 10.
  • the dose of medicament may be delivered using any method described herein.
  • the cartridge 200 is coupled to the reusable injector device 100.
  • the cartridge 200 may be coupled using any coupling method described herein.
  • a cap 260 is removed from the cartridge.
  • the cap 260 may be removed by any cap removal method described herein, for example.
  • the cap 260 may be removed to cause the needle cover 240 to move from its initial position to its primed position, ready for an injection.
  • the needle cover 240 is moved within the cassette outer housing 210 from its dose delivery position to its post-dose delivery position. This movement may be caused by removing the needle cover 240 from the injection site to cause the needle cover 240 to axially translate out of the cassette outer housing 210.
  • the cartridge 200 is uncoupled from the reusable injector device 100.
  • the cartridge 200 may then be safely discarded while the reusable injector device 100 can be coupled to a new cartridge 200 to perform a further injection.
  • drug or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier.
  • An active pharmaceutical ingredient (“API”) in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.
  • a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
  • API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.
  • the drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device.
  • the drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
  • the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C).
  • the drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders.
  • disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism.
  • Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.
  • APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th -edition.
  • APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof.
  • an insulin e.g., human insulin, or a human insulin analogue or derivative
  • GLP-1 glucagon-like peptide
  • DPP4 dipeptidyl peptidase-4
  • analogue and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue.
  • the added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues.
  • Insulin analogues are also referred to as "insulin receptor ligands".
  • the term ..derivative refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g., a fatty acid) is bound to one or more of the amino acids.
  • one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.
  • insulin analogues examples include Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-g
  • GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN- 9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1, GSK- 2
  • oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.
  • DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Nafarelin
  • Goserelin Goserelin.
  • polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.
  • antibody refers to an immunoglobulin molecule or an antigenbinding portion thereof.
  • antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen.
  • the antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody.
  • the antibody has effector function and can fix complement.
  • the antibody has reduced or no ability to bind an Fc receptor.
  • the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • fragment refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen.
  • Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments.
  • Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.
  • SMIP small modular immunopharmaceuticals
  • CDR complementarity-determining region
  • framework region refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding.
  • framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1:2014(E), needle-based injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems.
  • the container may be a replaceable container or an integrated non-replaceable container.
  • a multi-dose container system may involve a needle-based medicament delivery device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • Another multi-dose container system may involve a needle-based medicament delivery device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).
  • a single-dose container system may involve a needle-based medicament delivery device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needlebased medicament delivery device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système d'administration de médicaments (10) comprenant un dispositif injecteur réutilisable (100) et une cartouche (200) à utiliser avec le dispositif injecteur réutilisable, la cartouche et le dispositif injecteur réutilisable pouvant être combinés pour l'administration de médicaments, puis séparés, la cartouche comprenant : un boîtier externe de cassette (210) ; une seringue pré-remplie (230) placée à l'intérieur du boîtier externe de cassette, la seringue pré-remplie comprenant une aiguille (233) ; et un protège-aiguille (240) placé à l'intérieur du boîtier externe de cassette et entourant la seringue pré-remplie, le dispositif injecteur réutilisable comprenant : un boîtier (110) ; une navette de protège-aiguille (120) déplaçable à l'intérieur du boîtier contre un ressort navette de protège-aiguille (121) ; et une tige de piston (170) conçue pour administrer un médicament à partir de la seringue pré-remplie lors de l'utilisation ; et lorsque la cartouche et le dispositif injecteur réutilisable sont accouplés, la navette de protège-aiguille vient en prise avec le protège-aiguille pour entraîner le protège-aiguille dans une direction proximale.
PCT/EP2024/088064 2023-12-21 2024-12-20 Système d'administration de médicaments, cartouche et dispositif injecteur réutilisable Pending WO2025133224A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23315478.0 2023-12-21
EP23315478 2023-12-21

Publications (2)

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WO2025133224A2 true WO2025133224A2 (fr) 2025-06-26
WO2025133224A3 WO2025133224A3 (fr) 2025-09-04

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Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IT1299318B1 (it) * 1998-01-20 2000-03-16 Tecnologia S A S Di Valentino Dispositivo dosatore ed erogatore di prodotti fluidi o pastosi di tipo manuale a siringa.
WO2011076281A1 (fr) * 2009-12-23 2011-06-30 Tecpharma Licensing Ag Dispositif pour retirer un capuchon de protection d'aiguille d'une aiguille
WO2015118550A2 (fr) * 2014-02-10 2015-08-13 Elcam Medical Agricultural Cooperative Association Ltd. Auto-injecteur semi-jetable
WO2017114934A1 (fr) * 2015-12-30 2017-07-06 Novo Nordisk A/S Injecteur automatique à déclenchement de protection d'aiguille
US12161848B2 (en) * 2018-10-05 2024-12-10 Phillips-Medisize A/S Auto injector with effective insertion system
WO2021045950A1 (fr) * 2019-09-06 2021-03-11 Becton, Dickinson And Company Stylo injecteur avec protection rétractable
EP4255538A1 (fr) * 2020-12-02 2023-10-11 Sanofi Dispositif d'administration de médicament
EP4129363B1 (fr) * 2021-08-03 2025-10-08 Ypsomed AG Auto-injecteur avec unité de seringue jetable
US20250082860A1 (en) * 2022-01-12 2025-03-13 Shl Medical Ag Sub-assembly of a medicament delivery device

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Publication number Publication date
WO2025133224A3 (fr) 2025-09-04

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