Drug delivery device The present application relates to a drug delivery

Abstract

The present disclosure describes a drug delivery device comprising an actuation mechanism configured to exert an action on a drug container to expel a drug, the actuation mechanism comprising a rear assembly configured to maintain the actuation mechanism in a pre-tensioned state, wherein the rear assembly further comprises a transport lock mechanism, a support and holding mechanism for a feedback member and an activation member, and an activation member shroud. Further, there is an elongated housing having a proximal end and an opposite distal end for accommodating the rear assembly, the drug container, the actuation mechanism and the activation mechanism shroud, wherein the housing further comprises a guide member capable of interacting with the transport lock mechanism of the rear assembly and / or a container holder for the drug container. There is further a detachable rear cap, wherein the biased activation member shroud is axially slidable from a proximally extended position to a retracted position relative to the housing and operably connected to a tubular coupling member that rotates the coupling member from an initial, non-activated rotational position to an activated rotational position upon the activation member shroud being slid from the extended position to the retracted position; and wherein the coupling member further comprises a blocking element arranged to block the activation member shroud in a final position after expelling the drug.

Description

TECHNICAL FIELD

[0001] The present invention relates to an improved drug delivery device, an automatic drug delivery device that is easier to secure and assemble, and in particular to an automatic injector for dispensing a fluid product. Automatic drug delivery devices are known in the art, but these devices still have some drawbacks that need to be overcome. Therefore, the present invention aims to overcome these drawbacks and to provide an improved safety transport locking mechanism, an improved drive mechanism, an improved syringe support device, an improved cap assembly, and an automatic shielding and locking mechanism of the injection needle. BACKGROUND

[0002] Drug delivery devices such as automatic injectors are very popular on the market because they facilitate the management of the administration of medication by the user.

[0003] For example, the drug delivery device described in WO 2011 / 123024 has been very successful commercially because of its robustness, simplicity and usability, among other features. However, the Applicant has realized that there is still room for further improvement in the drive mechanism, locking features and other features in drug delivery devices, such as the ones described in WO 2011 / 123034 or WO 2015 / 169608 or WO 2016 / 169719.

[0004] The present disclosure is applicable to a variety of drug delivery devices, including but not limited to devices that automatically, semi-automatically or manually deliver one or more doses of a drug by injection (with and without a needle), inhalation, infusion, nebulization, drops, patches and implants. Incorporating one or more automatic feedback mechanisms into these medical devices ensures that the user of the device is notified of the start of the drug delivery process.

[0005] One aspect of the present disclosure relates to a drug delivery device delivered as sub- assemblies to be finally assembled into a device such as an auto-injector. One of the sub-assemblies can be a power unit which can comprise a pre-tensioned plunger rod provided with a control member configured to release the pre-tensioned plunger rod in the assembled drug delivery device. To this end, the control member is movable so that another element, typically comprised in a different sub-assembly, can interact with the control member when a user of the drug delivery device is preparing to administer a dose of a drug. It is to be prevented that the power unit is accidentally activated during transportation of the sub-assemblies due to vibrations, movements and impacts, while at the same time avoiding to complicate or obstruct the assembly or locking mechanism. Therefore, it is required to ensure that the control members are securely held in place so that they do not accidentally activate the power unit. Some attempts have been made in the industry to solve these problems. WO2018 / 206583 discloses a transport lock assembly for a drug delivery device, wherein the transport lock assembly comprises a power unit having a locking member configured to interact with a control member, the locking member being movable relative to the control member from a first state in which the control member is fixed to a second state in which the control member is free to move; wherein the transport lock assembly further comprises a housing portion having a key member, whereby assembly of the power unit with the housing portion causes the key member to move the locking member from the first state to the second state.

[0006] One aspect of the present disclosure relates to a drive mechanism which is typically assembled together with a power source which in many cases is a compression drive spring in a tensioned state. The drive spring is typically held in such a tensioned state by components of the unit and does not exert any force on the housing of the drug delivery device in an inactive state.

[0007] When the components are assembled within the housing, the housing is typically encapsulated by some kind of encapsulation cap, such as an end cap. This attachment can be made in a number of ways, such as gluing, plastic welding, threading or bayonet threading. Some of these attachment ways typically provide a reliable attachment, but are not optimal from an assembly point of view as they require a considerable amount of time to make the attachment or make the moulding complex in order to obtain the shape and required tolerances which adds to the manufacturing costs. This can not be acceptable, for example, if the drug delivery device is so-called disposable and is thrown away or discarded after use.

[0008] Another prior art document, US 5026349 A, describes a medical injector device comprising an injector having a barrel with a lateral protrusion, a needle, a plunger in the barrel having a portion extending from the barrel opposite the needle. The injector device has a body having a forward end for the needle and a rearward end portion for the extending portion of the plunger; a trigger movable rearward from the front of the body under pressure from the user's muscle; a receiver for holding the injector in axial alignment with the body, the receiver comprising a guide having a cavity for releasably holding the barrel and having a lateral opening for radial movement of the barrel into the cavity; an alignment for holding the injector in lateral alignment with the body during insertion of the injector into the receiver, the alignment comprising opposing entry surfaces at the forwardmost end of the guide for centering the contact portion of the barrel laterally, and a rear guide rearward of the entry surfaces for centering the rear of the injector laterally; the injector being movable in the body from a first position forward to a second position, the needle extending beyond the surface of the trigger to a degree to penetrate the muscle in the second position; an actuator for moving the plunger forward; a latch for preventing operation of the actuator; and a release connected to the trigger for releasing the latch during injection, whereby the actuator moves the plunger forward within the barrel and the injector moves from the first position to the second position.

[0009] One aspect of the present disclosure relates to an automatic shielding mechanism for shielding an injection needle after the drug delivery device has been withdrawn. This is typically done by a needle shield which is extended in proximal direction under the action of a spring or the like and encloses the needle tip when the drug delivery device is removed from the drug delivery site. In the fully extended position the needle shield is locked by a suitable locking element so that the needle shield cannot be pushed back into the drug delivery device and expose the injection needle. These functions can be triggered or activated by the movement of the needle shield during retraction into and extension from the drug delivery device. One example of these features is disclosed in document WO 2016 / 202555 which relates to a drug delivery device comprising a housing, a biased drug delivery member shield arranged to be movable relative to the housing from a proximally extended position to a retracted position, a power unit comprising a plunger rod and a force element arranged to exert an action on the plunger rod, the power unit being actuated by a release clip movable relative to the housing and arranged onto said plunger rod for releasably holding said plunger rod using the force element in a tensioned state. A rotation body is provided with guide elements and a drug delivery member shield locking element on its outer surface, wherein said drug delivery member shield is provided with a release clip activation element for releasing said plunger rod. A rotation body actuation element cooperates with the guide elements to rotate the rotation body. Upon movement of the drug delivery member shield to the retracted position, and upon movement of the drug delivery member shield back to the extended position, the rotation body actuation element engages with the drug delivery member shield locking element and locks the drug delivery member shield in a shielding position after removal of the drug delivery device from the drug delivery site.

[0010] One aspect of the present disclosure relates to a dosing mechanism as explained in prior art document WO 2018 / 010947 which relates to a dosing mechanism for a drug delivery device, the dosing mechanism comprising a movable sleeve and a delivery member cover having a distal portion configured to receive the movable sleeve and configured to be linearly displaceable relative to the movable sleeve between a first position and a second position, wherein the distal portion has an end face defining a guide surface and the movable sleeve has a first follower structure extending radially outwardly configured to cooperate with the guide surface when the delivery member cover is moved from the first position towards the second position resulting in a rotation of the movable sleeve.

[0011] One aspect of the present disclosure relates to a syringe holder for an auto-injector device as described in prior art document WO 2013 / 089620, which describes an auto-injector device comprising a movable plunger, a needle and a tubular needle shield. The auto-injector device has an elongated housing with a drive mechanism and a syringe holder for supporting a fragile syringe and preventing damage to the syringe. The present disclosure also relates to a method of assembling the auto-injector device of the invention. Further solutions are described, for example, in prior art document WO 2013 / 077800, which describes an invention relating to an injection device comprising a housing, a container holder configured to accommodate a drug container having a needle attached to one end thereof, and a stopper sealing the drug container at the other end thereof and slidably arranged within the drug container. A drive unit comprising a plunger rod and a plunger drive device, wherein the plunger drive device is operatively associated with the drive unit, a first energy storage member and an injection indication mechanism, wherein the injection indication mechanism comprises a haptic signaling element and a drive mechanism for driving the haptic signaling element, the drive mechanism being coupled to the plunger drive device.

[0012] A further example of a prior art solution is given in US 8,961,463 B2, which describes a dual dose auto-injector for medicaments, wherein the locking and release of the drive spring of the auto-injector is controlled by a stepped guide with a slope for two successive slides of a slide connected by a spring and to the syringe and plunger. The guide and the slide are pivotable relative to each other and to the sliding direction, while the syringe can only slide axially. In order to allow or prohibit the slide to slide within the guide, an angularly moving loading member is provided, which is formed with a guide track which is essentially equal to the guide track of a stationary member formed with the guide. However, these features can not prevent misalignments during final assembly leading to malfunctions.

[0013] One aspect of the present disclosure relates to a cap assembly for a drug delivery device. The cap assembly is configured to be mounted onto a drug delivery member shield, thereby protecting the drug delivery member shield and the drug delivery member. In order to protect the drug delivery member and to keep it in a sterile state, the drug delivery member can be provided with a drug delivery member shield or sheath, such as a flexible needle shield (FNS) or a rigid needle shield (RNS). Thus, during assembly of the drug container or drug delivery device, the drug delivery member shield can be attached to the drug container to cover the drug delivery member. Furthermore, the drug delivery device can comprise a removable cap which is mounted to the proximal end of the housing (i.e. the end of the drug delivery device which is placed towards the injection site during drug delivery) or to the proximal end of the drug container. The removable cap has the function to provide mechanical protection for the drug delivery member when attached to the housing or drug container and also removes the drug delivery member shield when the cap is removed from the housing. SUMMARY

[0014] The present disclosure is applicable to a variety of medical devices, including but not limited to devices that automatically, semi-automatically or manually deliver one or more doses of a medicament by injection (with and without a needle), inhalation, infusion, nebulization, drops, patches and implants. Incorporating one or more automatic feedback mechanisms into these medical devices ensures that the user of the device receives a notification that the drug delivery process has started.

[0015] In the present disclosure, when the term "distal direction" is used, it refers to the direction away from the dose delivery site during use of the drug delivery device. When the term "distal portion / end" is used, it refers to the portion / end of the drug delivery device or its components which is farthest from the dose delivery site when the drug delivery device is in use. Correspondingly, when the term "proximal direction" is used, it refers to the direction towards the dose delivery site during use of the drug delivery device. When the term "proximal portion / end" is used, it refers to the portion / end of the drug delivery device or its components which is closest to the dose delivery site when the drug delivery device is in use.

[0016] Furthermore, the term "longitudinal", "axial" or grammatical variations thereof refers to the direction generally in the direction of the longest extension of the device and / or component, extending along the device or its components from the proximal end to the distal end.

[0017] Similarly, the term "transverse" or grammatical variations thereof refers to the direction generally perpendicular to the longitudinal direction.

[0018] Generally, unless otherwise defined, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field. All references to a / an / the element, apparatus, component, means, device, etc. are to be interpreted openly as referring to at least one instance of whatever is referred to unless indicated otherwise.

[0019] "Configured to", as used herein, refers to existing features of devices, elements, and methods that enable the devices, elements, and methods to perform a specified function without further modification. For purposes of this disclosure, devices, elements, and methods described as "configured to" perform a specified function can additionally or alternatively be described as "adapted to" and / or "operative to" perform that function.

[0020] During final assembly and prior to shipping of the subassembly, the drug delivery device, especially the engagement parts, can be damaged or weakened, and the shipping lock mechanism and assembly mechanism must be strong enough to hold the subassembly safely together during shipping and final assembly, and simple enough to facilitate assembly. In view of this, it is a general object of the present disclosure to provide a drug delivery device that addresses or at least mitigates the problems of the prior art.

[0021] According to a first aspect, the drug delivery device comprises an actuation mechanism configured to exert an action on a drug container to expel a drug, the actuation mechanism comprising a rear assembly configured to maintain the actuation mechanism in a pre-tensioned state, wherein the rear assembly further comprises a shipping lock mechanism, a support and holding mechanism for a feedback member and an activation member, and an activation member shield; further, an elongated housing having a proximal end and an opposite distal end houses the rear assembly, the drug container, the actuation mechanism and the activation mechanism shield, wherein the housing further comprises a guide member that can interact with the shipping lock mechanism of the rear assembly and / or a container holder for the drug container; and a separable rear cap; wherein the biased activation member shield is axially slidable from a proximally extended position to a retracted position relative to the housing, and is operatively connected to a tubular coupling member that rotates the coupling member from an initial, non-activated rotational position to an activated rotational position upon sliding of the activation member shield from the extended position to the retracted position; and wherein the coupling member further comprises a blocking element arranged to block the activation member shield in a final position after expelling of the drug.

[0022] According to another aspect, the activation member shield further comprises at least one arm having a flexible radially inwardly extending crosspiece arranged in a recess of the arm of the activation member shield and exerting a force on the drug holder.

[0023] In another aspect of the drug delivery device, when the drug holder is introduced from the distal end into the distal opening of the activation member shield, the inwardly extending crosspiece acts as a stop, since the distal end of the drug holder exceeds the crosspiece, which can be bent back into the radially inward position, thereby preventing the drug holder from moving back towards the distal end.

[0024] The inwardly extending crossbar further comprises a radially inwardly extending protrusion providing an enlarged stop surface for the medicament holder allowing for a smaller bending movement of the crossbar or a radially smaller medicament holder.

[0025] The transport lock mechanism comprises a radially outwardly extending locking member arranged on the actuation member and configured to interact with a mating member being part of the coupling member and configured to engage with the locking member thereby preventing axial movement of the coupling member.

[0026] When the transport lock mechanism is in the first state, the mating member cooperates with the respective locking member of the coupling member thereby preventing rotation of the coupling member relative to the actuation member and the locking member; in the second state, the guiding member of the housing abuts a surface of the transport lock mechanism and pushes the locking member out of engagement with the respective mating member during final assembly.

[0027] According to another aspect, the housing comprises at least one axially extending protrusion being a guiding member arranged such that at least one arm of the activation member shield is axially guided and prevented from radial movement beyond an abutment position with the protrusion.

[0028] According to another aspect, the actuation mechanism further comprises a resilient member and wherein the activation member comprises at least one arm having a tapered distal portion, wherein the tapered distal portion defines a guiding surface at one of the longitudinal sides, wherein the guiding surface is configured to cooperate with the coupling member when the resilient member biases the activation member shield towards an activated rotational position.

[0029] Rotating the coupling member from an initial non-activated rotational position to an activated rotational position comprises abutting the guiding surface against a radially outwardly extending protrusion optionally located on a circumferential annular rib on the coupling member, wherein the protrusion optionally has a sloped contact surface complementary to the guiding surface.

[0030] The coupling member further comprises a protrusion defining a flexible crossbar that can be compressed radially inwardly when one of the longitudinal sides of the activation member arm slides over the flexible crossbar.

[0031] The flexible crossbar is a blocking element that bends radially outwardly when the first resilient member of the rear assembly causes the medicament to be expelled thereby axially displacing the activation member shield in proximal direction, wherein the flexible crossbar bends radially outwardly when the distal end portion of the activation member arm disengages and releases the flexible crossbar; wherein the flexible crossbar provides an abutment surface for the distal end portion thereby preventing distal movement of the activation member shield.

[0032] The drug delivery device further comprises a guiding member for controlling the movement of the container holder within the housing when the container holder is mounted longitudinally within the housing, wherein the guiding member defines protrusions arranged along the inner surface of the housing, configured to fit into corresponding grooves arranged along the outer surface of the container holder as guiding members.

[0033] The guiding member of the housing further abuts a surface of the transport lock mechanism and pushes the locking member out of engagement with the corresponding mating member during final assembly.

[0034] The support and retention mechanism for the feedback member and the activation member comprises an actuation piece having one or more engagement means configured to engage with the engagement member of the back cap, wherein the engagement member has a flexible crosspiece having a beveled proximal edge configured to guide the flexible crosspiece into the housing during assembly.

[0035] The engagement means define a recess on at least one longitudinal protrusion arranged along the outer surface of the actuation piece, the engagement member having a complementary mating shape to fit into the recess and securely hold the cap in place upon assembly of the back cap, wherein the recess optionally has a hook for retaining the engagement member of the cap in a locked state, such that the cap is non-removable once assembly is complete.

[0036] The actuation piece further comprises at least one locking element in the form of a protrusion extending radially inwardly along the inner surface of the actuation piece, the locking element abutting the bottom of a support recess formed by the two side arms of the distal portion of the support structure, wherein the locking element engages by fitting within the width of the recess to prevent distal movement of the feedback member and rotational movement of the support structure.

[0037] The actuation piece further comprises at least one engagement member in the form of a protrusion extending radially inwardly, configured to engage with a corresponding recess arranged on the outer surface of the support structure, the support structure sliding within the tubular actuation piece from the proximal end in the distal direction during assembly until the engagement member flexes into the corresponding recess, thereby preventing any further movement of the support structure in the distal direction. BRIEF DESCRIPTION OF DRAWINGS

[0038] Embodiments of the present application will now be described, by way of example only, with reference to the accompanying drawings in which:

[0039] Figure 1 A perspective view of the assembled drug delivery device of the present application is shown.

[0040] Figure 2A And Figure 2B A perspective view of the assembled drug delivery device of the present application is shown. Figure 1 A partial exploded view of the assembled drug delivery device of the present application in

[0041] Figure 3 An exploded view of the delivery device is shown. Figure 1

[0042] Figure 4A And Figure 4B A medicament device in a pre-use state is shown, wherein a perspective view of the actuation mechanism is shown without a housing in Figure 4A but with a housing in Figure 4B .

[0043] Figure 5A And Figure 5B A medicament device in an activated state ready for use is shown, wherein a perspective view of the actuation mechanism is shown without a housing in Figure 5A but with a housing in Figure 5B .

[0044] Figure 6A And Figure 6B A medicament device in a post-use state is shown, wherein a perspective view of the actuation mechanism is shown without a housing in Figure 6A but with a housing in Figure 6B .

[0045] Figure 7A A sub-assembly of the power unit with the medicament container is shown.

[0046] Figure 7B A perspective view of the power unit is shown.

[0047] Figure 7C A fully exploded view of the power unit of Figure 7B is shown.

[0048] Figure 7D The support structure of the power unit is shown in more detail.

[0049] Figure 7E A perspective view of the activation member of the power unit of Figure 7B is shown.

[0050] Figure 8A A cross-sectional view of the housing taken along the longitudinal axis L is shown.

[0051] Figure 8B Another cross-sectional view of the housing of Figure 8A after a rotation of 180 degrees is shown.

[0052] Figure 8C A perspective view of the housing is shown.

[0053] Figure 8D A side view of the sub-assembly of Figure 4A before the locking mechanism is activated is shown. ​

[0054] Figures 9A to 9C The activation phase is shown as well as the two phases of use and readiness. Figure 9A The needle guard position before activation is shown. Figure 9B The displacement of the needle guard during activation is shown, Figure 9C The needle guard position in the activated state is shown.

[0055] Figures 10A to 10D The displacement of the needle guard is shown in more detail in perspective view. Figures 9A to 9C Figure 10E The locking position of the needle guard after use is shown.

[0056] Figure 11A , Figure 11B and Figure 11D A perspective detail of the transport lock mechanism of the power unit is shown.

[0057] Figure 11C A perspective view of the housing is shown.

[0058] Figure 12A Details of the distal part of the support structure of the power unit are shown.

[0059] Figure 12B , Figure 12C and Figure 12D The rear cap is shown in different perspective views.

[0060] Figure 12E and Figure 12F Different rear assemblies with the rear cap are shown, Figure 12E A perspective view is shown.

[0061] Figure 12F A cross-sectional view of an embodiment of Figure 12E is shown.

[0062] Figure 12G An alternative embodiment of the rear assembly is shown.

[0063] Figure 12H A partial exploded view of the rear assembly of Figure 12G is shown.

[0064] Figure 12J and Figure 12K A perspective view and a side view of the rear assembly of Figure 12G is shown, where the cap is not attached.

[0065] Figure 12L and Figure 12M A perspective view of the rear cap of Figure 12G is shown.

[0066] Figure 13A ​A cross-sectional view of the assembled rear support structure and actuator is shown.

[0067] Figure 13B A perspective view of the actuator is shown.

[0068] Figure 14 The actuator and support structure are shown in a side view. Detailed Implementation

[0069] Various modifications are possible to the embodiments described, and those skilled in the art will be able to conceive of such modifications without departing from the invention as defined by the appended claims.

[0070] Typically, the drug delivery device may be, for example, an auto-injector or a pen injector. In one example, the drug delivery device includes a housing 10, a drug container 20 within the housing, a container holder 30, a drug delivery actuation mechanism 11, and a removable cap 16, wherein the drug container includes a drug cartridge, syringe, drug bag, cartridge, or any suitable drug container, a drug delivery component (e.g., a needle or nozzle), and a drug delivery component guard 38, and wherein the cap 16 includes a needle guard remover 160. The drug delivery device may be a single-use or reusable device.

[0071] The embodiment of the drug delivery device 100 of this disclosure shown in the accompanying drawings is designed with a generally elongated tubular housing 10, which may have a generally smooth shape or any other suitable cross-sectional shape. Figure 1 As shown, the drug delivery device 100 has a distal end 1 and a proximal end 2 extending along a longitudinal axis L. As shown in FIG. 2, the housing 10 is arranged to house the drug delivery actuation mechanism 11. At the proximal end 2 of the housing 10, the drug delivery device 100 may also be provided with a removable cap 16. If the container has a fixedly attached injection needle with a needle guard, the cap 16 may also be provided with a needle guard remover, so that the needle guard can be removed from the needle when the cap 6 is removed from the proximal end of the housing 10. The cap 16 is designed to engage with the proximal portion of the housing and form a removable connection. The cap 16 includes a generally tubular body 161 and a top cover 162, the body 161 optionally having a circumferentially outwardly extending crossbar, and the top cover 162 facilitating gripping of the cap 16. Typically, the cap has a cross-sectional shape generally similar to that of the housing 10 and has an opening pointing distally. The diameter of the tubular body 161 of the cap 16 is usually equal to or slightly larger than the outer diameter of the drug delivery component shroud remover 160.

[0072] The drug container 20 further comprises a drug delivery member guard or shroud 38 in the form of a generally elongated tubular member. The cap 16 is connected to the proximal end of the drug delivery actuation mechanism 11 by a central element, i.e. a drug delivery member shroud remover 160, which extends into the tubular activation member 14, i.e. the needle guard, and surrounds the drug delivery member shroud 38, as Figure 3 illustrated.

[0073] The drug delivery actuation mechanism 11 as Figure 2B illustrated is capable of effecting, upon activation, delivery of a dose of liquid drug from a drug container 20 arranged within the housing 10 via a drug delivery member 36, e.g. an injection needle, which is protected and shielded by a delivery member shroud 38, e.g. a needle shroud. As shown, the drug delivery member shroud 38 is a so-called RNS (rigid needle shroud) which holds the injection needle 36 in a sterile environment until the drug delivery device 100 is ready for use. Alternatively, a FNS (flexible needle shroud) can also be used as drug delivery member shroud. The shroud 38 is removed from the drug container 20 by a drug delivery member shroud remover 160 which is axially fixed to the cap 16 and has a generally tubular body which inner diameter generally corresponds to the outer diameter of the drug delivery shroud 38. The drug delivery actuation mechanism 11 can have a variety of designs and functions which can be applied and work with the locking mechanism disclosed in the present disclosure.

[0074] The drug container 20 is further arranged within a container holder 30 to hold the drug container within the housing 10. The container holder 30 optionally further has guiding members in the form of longitudinal protrusions, e.g. ribs 301, 301’ on the outer shell of the container holder 30, which are configured to engage with a receiving structure during or after assembly and provide alignment features and / or stop or retention features. The drug container 20 has a predetermined volume of drug and a slidable bung 22 which seals the distal end of the drug container 20, as Figure 3 illustrated. At the proximal end of the drug container 20, a delivery member 36 is fixedly or removably attached. The drug container 20 can be a syringe provided with a needle 36 as delivery member, but is not limited thereto. Other embodiments can comprise a cartridge with a membrane or the like, wherein the delivery member can not be a needle, e.g. a nozzle or a spout.

[0075] In one embodiment, the delivery actuation mechanism 11 comprises an activation member 14 having a generally hollow tubular body with an annular contact member 44 at its proximal end 2 and a first resilient member 28 arranged between the distally facing circular ledge of the contact member and the proximally facing surface of the container holder 30. The first resilient member 28 is configured to exert a force on the activation member 14 in the proximal direction. In the activated state of the drug delivery device 100, the contact member 44 is aligned with the proximal end 2 of the housing 10, whereas in the ready state of the drug delivery device as shown in Figure 4A and Figure 4B a portion of the tubular body with the contact member 44 protrudes from the proximal end of the housing 10 at a predetermined distance from the proximal end 2 of the housing 10.

[0076] The tubular activation member 14 is movably arranged at the proximal end 2 of the housing 10 and can be moved between an extended position covering the delivery member 36, e.g. the needle, as shown in Figure 4A , 4B and a retracted position as shown in Figure 5A , 5B in which a puncture with the needle 36 can be performed. The activation member 14 is preferably urged in the proximal direction by the first resilient member or spring 28. The activation member 14 also serves to protect and conceal the drug delivery member 36, e.g. the needle.

[0077] The delivery actuation mechanism 11 further comprises a rear assembly 3 or power unit comprising an elongated guide rod 26, e.g. a plunger rod, an actuation member 35 or a rotor, a second resilient member or compression spring 24 and a plunger rod 34 arranged to exert an action on the bung 22 to deliver a dose of drug through the needle 36. The plunger rod 34 is a hollow rod, driven by the second resilient member, e.g. the compression spring 24.

[0078] Figure 3 An exploded view of the actuation mechanism 11 of the drug delivery device 100 is shown, Figure 7C an exploded view of the rear assembly 3 is shown, which further comprises a support structure 33 for holding the plunger rod 34 in a pre-tensioned state, a movable coupling member 32 configured to interact with the support structure to release the plunger rod and a feedback member 18, all of which are part of the rear assembly, i.e. the power unit 3. The support structure has an elongated tubular body extending coaxially with the plunger rod 34 from a distal end 331 to a proximal end 332. The support structure 33 comprises at its proximal end 332 a holding element 334 in the form of an arm, which is flexible in a generally radial direction, as shown in Figure 7D ​The free end of the arm 334 is provided with a crosspiece 336 extending radially inwards, which is arranged to fit into a recess 341 of the plunger rod 34 for releasably holding the plunger rod 34, as Figure 7E The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 7D The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 7E The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 14 The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as

[0079] The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 7C The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as 12A The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as

[0080] The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 7C The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as 12A The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 2A The free end of the arm 334 is further provided with a support member 333 extending proximally and pointing radially outwards, forming an arc-shaped support member configured to interact with the distal end surface of the medicament container. The inner surface of the proximal portion of the support structure 33 is provided with a longitudinally extending groove 330 (as Figure 3 、 8D )。

[0081] The actuator 35 includes one or more engagement devices 338 configured to engage with engagement members 128 of the rear cap 12. One further advantage of the rear cap 12 is that, during assembly of the rear assembly 3, the distal support structure 335 is able to securely hold the second resilient member 24 while being compressed, and prevents the feedback member 18 from accidentally dislodging from its intended position during and after assembly. When engaged with the engagement devices 338, the one or more engagement members 128 are configured to easily engage with each other during assembly. The engagement members 128 are also designed to fit snugly into the housing 10, such that the housing prevents the engagement members 128 from accidentally disengaging or loosening from the engagement devices, thereby securely holding the rear cap 12 after assembly. Optionally, the proximal opening 120 of the rear cap may include a structural support element 122 that also engages with the distal end of the actuator 35 or support structure 33. Structural support element 122 abuts against various regions of actuator 35 or distal support structure 335, thereby enhancing engagement of the rear assembly 3. For example, this can prevent accidental rotation or lateral movement.

[0082] In one embodiment, such as Figure 13A , Figure 13B and Figure 14 As shown, the actuator 35 also includes radially inwardly extending protruding engaging members 352, 352', which are configured to engage with corresponding recesses 339, 339' on the outer surface of the support structure 33. During assembly of the power unit, the support structure 33 is introduced into the actuator 35, and thus the support structure slides from the proximal end to the distal end within the tubular actuator until the engaging members 352, 352' engage with the recesses 339, 339' on the surface of the support structure 33. Further distal movement is thus prevented; the hook-like engagement of the engaging members and the recesses does not allow for distal movement.

[0083] In one embodiment, the actuator 35 further includes locking elements 351, 351', as shown in FIG13 and Figure 14 As shown, these locking elements abut against the bottom of the support recess 337 formed by the two side arms of the distal support structure 335. These locking elements are radially inwardly extending protrusions at the distal end periphery of the actuator. The protrusions have extensions, so that they fit within the width of the recess from two opposite sides of the recess 337. In this example, they extend only slightly radially to abut against the edge of the end segment of the recess, thereby preventing rotational movement.

[0084] In most cases, the assembly of the drug delivery device or sub-assembly parts follows a certain procedure and this procedure is mostly an automated procedure, therefore, in the successive steps of the assembly, some partially assembled units have to be firmly held or supported, otherwise they can come off or move out of their intended position. In most cases, full automated assembly machines (FAAM) and high cavity tools are used. For these cases, the feedback member support recess 337 provides a fixed support for the U-shaped cradle 18 while the second elastic members (i.e. the plunger spring and the plunger rod) are assembled under force. The present disclosure solves the problem of the U-shaped cradle sliding into the back cap during assembly. The feedback member support recess 337 is defined by two or more arms of the distal support structure 335 between which the distal closed end of the U-shaped cradle can be placed. The distal support structure 335 thus prevents lateral sliding of the U-shaped cradle and provides a stable support or gripping surface for the FAAM machine to fix the sub-assembly while the first elastic member is tensioned during assembly.

[0085] In an alternative embodiment (not shown in the figures), the support structure 33 does not have a distal support structure 335 in the form of two or more arms, in which case the U-shaped cradle is placed on top of the distal support structure 335, i.e. the U-shaped cradle is placed on the opposite side of the support structure 35, the inner side of the end 335 is the end of the dose sound seat against which the U-shaped cradle hits and produces a sound indicating that the injection is almost complete. During assembly in a full automated machine, the sub-assembly is placed on the distal surface of the support structure with the U-shaped cradle and is held so that the U-shaped cradle cannot move when the elastic members are tensioned. Subsequently, the back cap 12 can be installed on the distal end of the back assembly 3 when the relevant parts are engaged with each other.

[0086] In one example, the back cap has a dome-like form with a cavity in its top face 126 at its proximal opening for receiving the distal support structure 335 of the support structure 33. The cavity can be defined by a support element 122 or be an open cavity. The engagement member 128 and the engagement means 338 can be a snap-fit fixing means, a tapered engagement means, a hook-shaped engagement means, or any other suitable engagement means.

[0087] In one example, the engagement member 128 defines a flexible ledge with a sloped proximal edge 129 to facilitate the sliding of the engagement member within the housing 10 during assembly. The engagement means 338 are arranged on a longitudinal protrusion along the outer surface of the actuator 35 and define a recess complementary to the form of the flexible ledge of the engagement member 128. During assembly, the housing forces the flexible ledge into the corresponding recess of the engagement means 338. The continuous force exerted by the housing 10 on the flexible ledge keeps the back cap 12 in place.

[0088] In another example, the engagement means 338 in the form of a recess further comprises a hook-like form at its distal end, so that the hook also locks the engagement member 128, thereby preventing the back cap 12 from moving in the distal direction.

[0089] In Figures 12G to 12M In one alternative embodiment, the back assembly 3" further comprises a support structure 33' with engagement means 338' in the form of radially extending flexible arms configured to snap into corresponding at least one engagement member 128' in the form of a slot arranged circumferentially on the cap 12'. The at least one engagement member 128' can be arranged on the periphery 124, extending longitudinally from the cap 12' and having a diameter equal to or smaller than the diameter of the cap. The engagement member 128' can be in the form of a recess inside the periphery 124, the recess can have a size larger than the size of the engagement means 338' so that the slightly different size of the engagement means 338' can fit inside the recess of the engagement member 128'. The engagement means 338' further comprises a hook-like form 338'a at its distal end, so that the hook 338'a also locks the engagement member 128', thereby preventing the back cap 12' from moving in the distal direction. The snap-fit engagement of the engagement means 338' with the engagement member 128' makes the cap 12' easy to assemble and securely held.

[0090] The cap 12' is further provided with structural support elements 122' configured to engage with guide ribs 123 arranged on the inner side of the tubular support structure 33'. In this example, the support elements are at least one pair of flexible legs 122' that can engage with the support structure 33' and the guide ribs 123, thereby preventing loose assembly, i.e. any radial or longitudinal movement of the cap 12'. One advantage is to reduce the tolerance requirements for assembly and to be able to avoid related side effects, such as the click-click noise due to lost parts. The engagement means 338' optionally further comprises flexible arms 339'' configured to engage with an actuation member (not shown in the figures).

[0091] Figure 1 And Figures 4A to 6B A simplified perspective view of the drug delivery device 100 is shown, wherein Figure 1 An initial, unactivated state of the drug delivery device 100 with cap 16 is shown. In Figure 4A An activated state of the drug delivery device 100 without the housing 10 and the cap 16 is shown, in Figure 4B The housing 10 and the cap 16 have been removed. Figure 5A An injection and penetration state of the drug delivery device 100 without the housing 10 is shown, Figure 5B The drug delivery device with the housing 10 is shown. Figure 6Aa drug delivery device 100 without housing 10 in the final locked state is shown, Figure 6B a drug delivery device with housing is shown. Figure 4A , 5A and 6A also shows a needle guard 14 slidably and coaxially arranged within the tubular housing 10. The cap 16 comprises a distal end surface which is in abutment with a proximal end surface of the annular contact member 44 of the needle guard 14, thereby allowing the needle guard 14 to be placed in the injection site upon manual operation and detachment of the cap 16, wherein the annular contact member 44 is in contact with the injection site. Upon further manual operation and pushing, i.e. pushing in the direction of the injection site, of the needle guard 14, the needle guard 44 is forced into the housing 10 from its inactive position to its active position to avoid an unintended actuation of the power unit 3, for example in case of vibrations during transport exerting pressure on the needle guard 14. In these cases, it has to be prevented that the coupling member 32 is moved into the release state prematurely. In this example, the release state is associated with the movable coupling member 32 which is configured to interact with a support structure for releasing the plunger rod. In the release state, the plunger rod can be freely moved. However, the coupling member 32 is configured to be rotated from the first locked position to the second unlocked position.

[0092] Upon pushing the needle guard 14 against the injection site by the user of the device, the coupling member 32 is caused to rotate from the first locked position to the second unlocked position. This causes the needle guard 14 to slide in axial direction relative to the housing 10 in distal direction. The annular contact member 44 has a proximal opening 441 and extends in axial direction with a predetermined length defining an annular structure. At least one arm 141 extends in axial direction from the annular contact member 44 towards the distal end 1 of the drug delivery device 100. This elongated structure 141 or needle guard arm is configured to interact with the coupling member 32. The at least one needle guard arm 141 has a triangular or trapezoidal tapering portion 140 tapering towards a distal portion 146, as Figure 9A , 9Band 9C. One side of the trapezoidal taper 140 defines a guide surface 1401 configured to cooperate with the protrusion 320, thereby defining a circumferential annular rib on the coupling member 32. The needle cover arm 141 can also be provided with a radially inwardly extending ledge 145. The drug delivery device 100 can be assembled at the manufacturing site, where the drug container 20 contains the drug and is assembled within the device, or the drug delivery device 100 can be supplied to the drug supplier for final assembly of the drug delivery device 100. When final assembly is performed by the drug supplier, the drug container 20 has to be introduced into the drug holder 30, which is optionally provided as a component of the drug delivery device and has to be integrated into the final assembled drug delivery device. Some components can be provided in a pre-assembled state. These interacting components often have irreversible engagement mechanisms, which often have a sensitive or delicate design, which can be damaged during shipping, or are accidentally replaced by a similar but different type. Thus, when introducing the drug container 20 into a damaged sub-assembly and final assembly of the drug device, it can finally not be possible to introduce the drug container at all, or to safely remove it from the drug delivery device.

[0093] The needle cover arm 141 is provided with a flexible ledge 145 extending radially outwardly from the needle cover. The flexible ledge 145 can further comprise a radially inwardly extending protrusion 1451 providing an enlarged stop surface. During assembly, the flexible ledge 145 can be bent inwardly to avoid protruding the needle cover 14 and can be slid into the housing 10. Optionally, a guide rib (e.g. 143) aligns the assembly of the needle cover. In case the flexible ledge 145 has a clearance when sliding into the housing, the flexible ledge 145 can be bent outwardly into the clearance. In this way, the radially inwardly extending protrusion provides a stop surface for the protrusion 106a radially extending from the inner surface of the housing 10. Thus, the flexible ledge 145 prevents the needle cover 14 from further movement in proximal direction along the longitudinal axis L.

[0094] In an alternative embodiment, the needle cover arm 141 with the flexible ledge 145 is bent outwardly when the drug holder is introduced into the tubular body of the needle cover 14. The flexible ledge 145 exerts a force on the drug holder 30, holding it in place and acting as a shock absorber in case of vibrations or shocks during handling or use of the drug delivery device. The flexible ledge 145 can further comprise a radially inwardly extending protrusion 1451 providing an enlarged stop surface, allowing for a smaller bending movement of the ledge 145 or the radially smaller drug holder 30. As Figure 8DAs shown, the protrusion 1451 extends inwardly into the interior space of the needle guard 14 and does not radially exceed the needle guard 14. When the drug holder 30 is introduced into the needle guard 14, the proximal circular rim of the drug holder 30 abuts the protrusion 1451, which allows the flexible crosspiece 145 to bend outwardly while the drug holder is further slid into the needle guard 14. Then, the enlarged stop surface 1451 of the flexible crosspiece 145 engages with the protrusion 106a extending radially inwardly from the inner surface of the housing 10. During assembly, the flexible crosspiece 145 can be bent radially outwardly so that, upon abutment with the protrusion 106a, the flexible crosspiece 145 prevents the needle guard 14 from further moving in the proximal direction along the longitudinal axis L. Thus, the needle guard 14 can be axially locked. The outer surface of the needle guard arm 141 can also have a guiding element, e.g. a groove 143, configured to interact with a counter guiding element on the inner surface of the housing 10 to prevent any rotational movement of the needle guard 14, but to allow longitudinal axial movement relative to the housing.

[0095] In one embodiment, one or more axially extending protrusions (101, 104) of the inner surface of the housing 10 can be arranged to interact with the longitudinal side faces (142, 142’) of the needle guard arm 141. The axially extending and radially inwardly extending protrusions (101, 104) are guiding ribs which are arranged and configured such that the needle guard arm 141 slides along these guiding ribs, thereby preventing any rotational movement of the needle guard 14.

[0096] The needle guard arm 141 engages with the coupling member 32 at a distal end portion 146 of the needle guard arm 141. Prior to activation of the drug delivery device, the end portion 146 of the needle guard arm 141 is located in front of the spacing between the two protrusions 320, 328 of the coupling member 32, as shown in Figure 9A and Figure 10A The protrusions 320, 328 of the coupling member 32 extend radially outwardly from the surface of the coupling member, and one of the protrusions 320 defines an annular rib of at least a predetermined circumferential length, and the other protrusion 328 defines a flexible crosspiece. Both the annular rib 320 and the flexible crosspiece 328 define a spacing 327 therebetween on the same radial ring, such that the trapezoidal end portion 146 of the needle guard arm 141 can be accommodated within this spacing. Upon axial movement of the needle guard in the distal direction, the end portion 146 of the needle guard arm 141 passes through the spacing 327, as shown in Figure 9B and Figure 10B The distal end portion 146 of the needle guard arm has a slanted or tapered shape on one longitudinal side, such that the trapezoidal shape passes through the spacing between the annular rib 320 and the flexible crosspiece 328. The needle guard arm 141 can continue to move in the distal direction until the width of the needle guard arm 141 is such that the side edges abut the annular rib and the flexible crosspiece 328, as shown inFigure 10C is shown.

[0097] Subsequently, as the needle cover 14 and the corresponding needle cover arm 141 further pass the distance 327, the needle cover arm 141 thereby slides over a flexible ledge 328 having longitudinal edges, forcing the flexible ledge to bend into the recess, thereby allowing the needle cover arm 141 to slide over the ledge 328. Furthermore, as the side edges of the needle cover arm 141 have abutted the edges of the annular rib 320, any further movement of the needle cover 14 translates into rotational movement of the coupling member 32. In other words, as the needle cover arm exerts a force on the edge portion of the annular rib with the tapered end portion 146 of the needle cover arm 141, the needle cover 14 activates and rotates the coupling member 32 by the engagement of the annular rib 320 with the needle cover arm 141. This exerted force activates the rotational movement of the coupling member 32.

[0098] The movement stops in a position as shown in Figure 9C and 10D optionally abutting the end edge of the coupling member, i.e. the tip of the needle cover arm 141 can abut the annular protrusion or structure. Subsequently, after activation, the needle cover 14 extends to a locked position, which enables the ledge 328 to bend out of the recess, which comprises a vertically extending structure, providing an abutment surface 329 for the end edge of the needle cover arm 141. The needle cover arm stops when abutting the surface 329 of the flexible ledge 328, the needle cover arm cannot be moved further distally. The needle cover is thereby axially locked as shown in Figure 10E .

[0099] In one embodiment, the needle guard 14 has two arms 141, 144 extending axially from the annular contact member 44 towards the distal end 1 of the drug delivery device 100. The outer surface of the needle guard arms 141, 144 can further have grooves 143, 143' (143' not shown in the figures) configured to interact with the inner surface of the housing 10, respectively. One or more axially extending protrusions of the inner surface of the housing can be in said one or more grooves 143, 143', configured to slide in the grooves 143, 143' of the needle guard arms 141, 144, thereby preventing any rotational movement of the needle guard 14. In this example, the needle guard arms are arranged opposite to each other, but other configurations are not excluded. The needle guard arms 141, 144 are further provided with flexible crosspieces 145, 147 extending radially outwards from the needle guard. The flexible crosspieces 145, 147 can further comprise radially inwardly extending protrusions 1451, 1471, which provide enlarged stop surfaces. During assembly, the flexible crosspieces 145, 147 can be bent inwards so that they do not protrude from the needle guard 14 and can be slid into the housing 10. Optionally, guiding ribs (e.g. 143) align the components of the needle guard. In case the flexible crosspieces 145, 147 have a spacing when sliding into the housing 10, the flexible crosspieces 145, 147 can be bent outwards into this spacing. In this way, the radially inwardly extending protrusions extend the needle guard arms radially and provide two stop surfaces for the circumferential protrusion 106a. The enlarged stop surfaces 1451 of the flexible crosspieces 145, 147 engage with the protrusion 106a extending radially inwards from the inner surface of the housing 10. Thus, the flexible crosspieces 145, 147 prevent the needle guard 14 from further moving in proximal direction along the longitudinal axis L.

[0100] In another optional embodiment, the needle guard arms 141, 144 can further be provided with radially inwardly extending crosspieces 145, 147, respectively, thereby exerting an elastic force on the drug holder 30. The flexible crosspieces 145 and 147 can further comprise radially inwardly extending protrusions 1451 and 1471 to provide enlarged stop surfaces, thereby allowing for a smaller bending movement of the crosspieces 145 or 147 or of the radially smaller drug holder 30. As Figure 8DAs shown, the protrusions 1451, 1471 extend inwardly into the interior space of the needle guard 14 and do not radially exceed the needle guard 14. When the drug holder 30 is introduced into the needle guard 14, the proximal circular rim of the drug holder 30 abuts the protrusions 1451, 1471, which allows the flexible crosspieces 145, 147 to bend outwardly while the drug holder is further slid into the needle guard 14. Then, the enlarged stop surfaces 1451, 1471 of the flexible crosspieces 145, 147 engage with the protrusions 106a extending radially inwardly from the inner surface of the housing 10. During assembly, the flexible crosspieces 145, 147 can be bent radially outwardly so that, upon abutment with the protrusions 106a, the flexible crosspieces 145, 147 prevent the needle guard 14 from further moving in the proximal direction along the longitudinal axis L. Thus, the needle guard 14 can be axially locked.

[0101] In one embodiment, two or more axially extending protrusions (101, 101', 104, 104') of the inner surface of the housing 10 can be arranged to interact with the longitudinal sides (142, 142', 148, 148') of the needle guard arms 141, 144. The axially extending and radially inwardly extending protrusions (142, 142', 148, 148') are guide ribs which are arranged and configured such that the needle guard arms 141, 144 each slide along these guide ribs, thereby preventing any rotational movement of the needle guard 14.

[0102] The needle guard arms 141, 144 engage with the coupling member 32 at the distal end portions 146, 146' of the needle guard arms 141, 144. Before the drug delivery device is activated, the ends 146, 146' of the needle guard arms 141, 144 are located in front of the spacing between the two respective protrusions 320, 328 and 320', 328' (328' not shown in the figures) of the coupling member 32, respectively, as shown in Figure 9A and Figure 10A The protrusions 320, 328 and 320', 328' of the coupling element 32 extend radially outwardly from the surface of the coupling element, and the two of the protrusions 320 and 320' define two annular ribs on the same circumferential ring and have a predetermined circumferential length. The other protrusions 328 and 328' define flexible crosspieces. The annular ribs 320, 320' and the flexible protrusions 328, 328' both define a respective spacing 327, 327' (327' not shown in the figures) between them on the same radial ring portion in pairs, so that the trapezoidal ends 146, 146' of the respective needle guard arms 141 and 144 can be accommodated within this spacing. When the needle guard is moved axially in the distal direction, the ends 146, 146' of the needle guard arms 141, 144 pass through the respective spacing 327, 327' (327' not shown in the figures), as shown in Figure 9B andFigure 10B The distal end portion of the needle guard arm has a triangular or trapezoidal shape on one longitudinal side, such that the triangular shape passes through the respective spacing between the annular rib 320, 320' and the respective flexible crosspiece 328, 328'. The needle guard arm 141, 144 can continue to move in distal direction until the width of the needle guard arm 141, 144 is such that the respective side edges abut the annular rib and the flexible crosspiece 328, 328', as shown in Figure 10C .

[0103] Subsequently, as the needle guard 14 and the respective needle guard arm 141, 144 further pass through the spacing 327, 327', the needle guard arm 141, 144' and their respective longitudinal edges slide over the flexible crosspiece 328, 328', forcing the flexible crosspiece to penetrate into the respective recess, thereby allowing the needle guard arm 141, 144' to slide over the crosspiece 328, 328'. Moreover, since the side edges of the needle guard arm 141, 144 already abut the edge of the annular rib 320, 320', any further movement of the needle guard 14 translates into a rotational movement of the coupling member 32. In other words, the needle guard 14 activates and rotates the coupling member 32 by the engagement of the annular rib 320, 320' with the needle guard arm 141, 144 when the needle guard arm exerts a force on the edge portion of the annular rib with the trapezoidal end portion 146, 146' of the needle guard arm 141, 144. This exerted force activates the rotational movement of the coupling member 32.

[0104] This movement stops in a position as shown in Figure 9C and 10D , optionally abutting the end edge of the coupling member, i.e. the tip of the needle guard arm 141, 144 can abut the annular protrusion or structure. Subsequently, after activation, the needle guard 14 extends to a locking position, which enables the crosspiece 328, 328' (328' not shown in the figure) to flex out of the recess 326, 326' (326' not shown in the figure), which comprises a vertically extending structure, respectively, providing an abutment surface 329, 329' (329' not shown in the figure) for the end edge of the needle guard arm 141, 144. The needle guard arm stops when abutting the surface 329, 329' of the flexible crosspiece 328, 328', the needle guard arm cannot move further in distal direction. The needle guard 14 is thereby axially locked, as shown in Figure 10E .

[0105] As mentioned above, the drug delivery device 100 can be assembled at the manufacturing site, where the drug container 20 contains the drug and is assembled within the device. Thus, the drug delivery device 100 is ready for use as it leaves the manufacturing site; or, the drug delivery device 100 can be provided to a drug supplier for final assembly of the drug delivery device 100. In the second case, it is more practical and advantageous for the drug supplier to receive pre-assembled components, if possible. Some components of the drug delivery device 100, such as the power unit 3, can be provided in a pre-assembled state. See the exploded view showing an exemplary power unit 3 with the individual components Figure 7C The advantages of receiving a pre-assembled power unit can be appreciated. Some challenges of a pre-assembled component like the power unit 3 can be accidental activation, etc. Thus, a proper shipping lock mechanism is provided during shipping to prevent accidental activation of the power unit 3.

[0106] In the following exemplary embodiment, an improved shipping lock mechanism is disclosed, wherein the coupling member 32 is rotationally movable about the longitudinal axis L and axially fixed relative to the actuation member 35, which further comprises a locking member 321 for preventing movement of the coupling member 32 relative to the actuation member 35. The locking member 321 is axially movable and rotationally locked relative to the actuation member 35 and relative to the coupling member 32. However, the locking member 321 is configured to interact with the coupling member 32 such that, when the locking member 321 is in a first state, the locking member 321 engages with a mating member 322, resulting in the coupling member 32 being fixed by the locking member 321. When the locking member 321 is moved to a second state, the control member 32 is released by the locking member 321.

[0107] The locking member 321 can comprise a support member 323, which can be a ring-shaped or tubular member arranged around the actuation member 35, the ring-shaped support member 323 being configured as an axial member, which can be a flexible integrated unit portion of the actuation member 35, preventing the support member 323 from being displaced axially or distally. Alternatively, the ring-shaped support member 323 can be configured as a rigid axial member fixedly attached to the actuation member 35 over at least a portion of the ring-shaped structure, preventing the ring-shaped support member 323 from being displaced axially and distally. An integrated locking member means fewer components to be assembled and reduces the tolerance chain, making the device more robust and reliable. In this case, the ring-shaped support member 323 is configured to be flexible in a distal direction at the ring-shaped portion where the at least one locking member 321 is located. The elasticity of the ring-shaped support member 323 allows the locking member 321 to re-engage with the corresponding mating member 322 if they are accidentally moved or disengaged during handling or shipping of the power unit. In other words, 323 is a flexible support member, which, as a Figure 11BThe flexible support member keeps the locking member 321 in a forward position in the slot of the mating member 322 of the coupling member 32 during transport of the subassembly. After final assembly, the support member 323 is moved back, i.e. in distal direction. However, the support member 323 can still be in a tensioned state, so that upon removal of the rear assembly 3, the support member 323 moves the locking member 321 again into the slot of the mating member 322 and thereby keeps the locking member 321 locked.

[0108] The mating member 322 is configured to be engageable with the coupling member 32, the mating member 322 and the support member 323 are shown in a disengaged state in Figure 11A and in an engaged state in Figure 11C A certain critical force needs to be applied to axially displace the support member 323 to disengage the mating member 322 from the respective locking member 321. During final assembly of the drug delivery device 100, the force required to disengage the locking member 321 is provided upon insertion of the power unit 3 into the housing 10. At this stage, the locking member 321 abuts a longitudinal elongated protrusion 106b located at an inner surface of the housing 10. The elongated protrusion 106b is configured to have a predetermined length and position within the housing 10 so as to provide a contact member for the locking member 321. During final assembly, upon providing the housing and introducing the power unit 3 into the housing 10, the locking member 321 is axially displaced in distal direction under the action of the elongated protrusion 106b due to the abutment of the distal end portion of the elongated protrusion 106b by the locking member 321, resulting in disengagement of the locking member from the mating member 322, thereby allowing rotational movement of the coupling member 32. After final assembly, the elongated protrusion 106b can further keep the transport lock 321 in a compressed state towards the distal direction, in other words, the distal end portion of the elongated protrusion 106b can keep in contact with the abutment surface 324 of the locking member 321, thereby keeping the transport lock mechanism in a disengaged state after assembly. The mating member 322 is configured to receive the locking member and can have a shape corresponding to the complementary shape of the locking member 321, so that the locking member fits exactly into the space of the mating member 322. Alternatively, the mating member can be configured to receive locking members of a plurality of different widths or lengths. To this end, the shape of the mating member 322 can be conical.

[0109] In one embodiment, the coupling member 32 is axially fixed and rotationally movable about the longitudinal axis relative to the actuation member 35, which further comprises at least two locking members 321 and 325 for preventing movement of the coupling member 32 relative to the actuation member 35. The locking members 321, 325 are axially movable and rotationally locked relative to the actuation member 35 and relative to the coupling member 32. However, the locking members 321, 325 are configured to interact with the coupling member 32 such that, when the locking members 321, 325 are in a first state, the locking members 321, 325 engage with the cooperating members 322, 322’ causing the coupling member 32 to be fixed by the locking members 321, 325. When the locking members 321, 325 are moved to a second state, the control member 32 is released by the locking members 321, 325.

[0110] The locking members 321, 325 can comprise a support member 323, which can be an annular or tubular member arranged around the actuation member 35, the annular support member 323 being configured as an axial member, which can be an integrated unit part of the actuation member 35 compressible such that the support member 323 is prevented from being displaced axially or distally. Alternatively, the annular support member 323 can be configured as a rigid axial member fixedly attached to the actuation member 35 over at least a portion of the annular structure such that the annular support member 323 is prevented from being displaced axially and distally. An integrated locking member means that there are fewer components to assemble and reduces the tolerance chain, making the device more robust and reliable. In this case, the annular support member 323 is configured to be bendable in a distal direction at an annular portion where the at least two locking members 321, 325 are located. The cooperating members 322, 322’ of the support member 323 engage with the coupling member 32. In Figure 11A In one embodiment, the coupling member 32 is axially fixed and rotationally movable about the longitudinal axis relative to the actuation member 35, which further comprises at least two locking members 321 and 325 for preventing movement of the coupling member 32 relative to the actuation member 35. The locking members 321, 325 are axially movable and rotationally locked relative to the actuation member 35 and relative to the coupling member 32. However, the locking members 321, 325 are configured to interact with the coupling member 32 such that, when the locking members 321, 325 are in a first state, the locking members 321, 325 engage with the cooperating members 322, 322’ causing the coupling member 32 to be fixed by the locking members 321, 325. When the locking members 321, 325 are moved to a second state, the control member 32 is released by the locking members 321, 325. Figure 11CIn some embodiments, one engagement member is shown engaged with one corresponding locking member. A certain threshold force needs to be applied to axially displace the support member 323 to disengage the engagement member 322 from the corresponding locking member 321, 325. The force required to disengage the locking members 321, 325 is provided during the final assembly of the drug delivery device 100, when the power unit 3 is inserted into the housing 10. At this stage, the locking members 321, 325 abut against longitudinal elongated protrusions 106b, 106b’ located at the inner surface of the housing 10. The elongated protrusions 106b, 106b’ are configured to have a predetermined length and position within the housing 10 so as to provide the locking members 321, 325 with corresponding contact members. During the final assembly, when the housing is provided and the power unit 3 is introduced into the housing 10, the locking members 321, 325 abut against the distal end portion of the corresponding elongated protrusion 106b, 106b’, thus the locking members 321, 325 are axially displaced in the distal direction under the action of the elongated protrusion 106b, 106b’, resulting in the disengagement of the locking members from the engagement members 322, 322’, thus allowing the rotational movement of the coupling member 32. After the final assembly, the elongated protrusions 106b, 106b’ can also keep the transport locks 321, 325 in a state compressed by the elongated protrusions 106b, 106b’ in the distal direction, in other words, the distal end portion of the elongated protrusions 106b, 106b’ can keep in contact with the abutment surface 324, 324’ (324’ not shown in the figure) of the locking members 321, 325, thus keeping the transport lock mechanism disengaged after assembly. The engagement members 322, 322’ are configured to receive the locking members and can have a shape corresponding to the complementary shape of the locking members 321, 325, such that the locking members fit exactly into the space of the engagement members 322, 322’. Alternatively, the engagement members can be configured to receive locking members of a plurality of different widths or lengths. To this end, the shape of the engagement members 322, 322’ can be tapered. In one embodiment, the engagement members 322 and 322’ can have different shapes. The locking member 321 can be identical in shape and form to the locking member 325. Alternatively, the locking member 321 can have a different shape and form from the locking member 325. The locking members 321 and 325 can be configured to have the same or different forces required to disengage them from the corresponding engagement members 322, 322’. One advantage of having two locking members is that even if one locking member can be defective or damaged, the other locking member can still provide the transport lock.

[0111] The drug delivery device is typically provided after assembly.

[0112] Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other embodiments can include more or less of each element shown in a given Figure. Still other embodiments can include some or all of the elements shown in combination with other elements not shown.

Claims

1. A drug delivery device (100), comprising: - An actuation mechanism (11) configured to act on a drug container (20) to dispense a drug includes: - Rear assembly (3, 3') including transport locking mechanisms (321, 322, 324), and support and holding mechanisms for the feedback member (18) and plunger rod (34); -Activate component (14); - An elongated housing (10) having a proximal end (2) and an opposing distal end (1) that houses a rear assembly (3), a drug container (20), an actuation mechanism (11) and an activation member (14), wherein the housing also includes a guide member (106b) capable of interacting with a transport lock mechanism (321, 324) of the rear assembly (3, 3'). - Back cap (12, 12'); The biased activation member (14) is axially slidable relative to the housing (10) from a proximal extended position to a retracted position and is operably connected to a tubular connecting member (32) which rotates the connecting member (32) from an initial inactive rotational position to an activated rotational position when the activation member (14) slides from the extended position to the retracted position. Furthermore, the connecting member (32) further includes a blocking element (328) arranged to block the activating member (14) in its final position after the drug is discharged. The transport locking mechanism (321, 322, 324) includes a radially outwardly extending locking member (321) arranged on the actuator (35) and configured to interact with a mating member (322), which is part of the connecting member (32) and configured to engage with the locking member (321) to prevent axial movement of the connecting member (32).

2. The drug delivery device (100) of claim 1, wherein the activation member (14) further comprises at least one arm (141, 144) having a flexible, radially inwardly extending crossbar (145, 147) disposed in a recess of the arm (141, 144) of the activation member (14), wherein the inwardly extending crossbar (145, 147) further comprises a radially inwardly extending protrusion (1451, 1471) providing an enlarged stop surface.

3. The drug delivery device (100) as claimed in claim 1, wherein, When the transport lock mechanism is in the first state, the cooperating member (322) cooperates with the corresponding locking member (321) of the connecting member (32) to prevent the connecting member (32) from rotating relative to the actuator and the locking member (321); In the second state, the guide member (106b) of the housing abuts against the surface (324) of the transport lock mechanism and pushes the locking member (321) out of engagement with the corresponding mating member (322) during final assembly.

4. The drug delivery device (100) of claim 1, wherein the housing includes at least one axially extending protrusion (101, 101', 104, 104'), the axially extending protrusion being a guide member arranged such that at least one arm (141, 144) of the activation member (14) is axially guided, and radial movement beyond the contact position with the protrusion is prevented by the axially extending protrusion (101, 101', 104, 104').

5. The drug delivery device (100) of claim 2, wherein the actuation mechanism (11) further comprises an elastic member (28) and wherein at least one arm (141, 144) of the activation member (14) comprises a tapered distal portion (140), wherein the tapered distal portion defines a guide surface (1401) at one of the longitudinal sides (142, 142'; 148, 148'), wherein the guide surface (1401) is configured to engage with the coupling member (32) when the elastic member (28) biases the activation member (14) toward an activated rotational position.

6. The drug delivery device (100) of claim 5, wherein rotating the connecting member (32) from an initial inactive rotational position to an active rotational position comprises abutting a guide surface (1401, 1401') against a radially outwardly extending protrusion (320) located on a circumferential annular rib on the connecting member (32), wherein the radially outwardly extending protrusion (320) comprises an inclined contact surface complementary to the guide surface.

7. The drug delivery device (100) as claimed in any of the preceding claims, wherein the connecting member (32) further includes a protrusion defining a flexible crossbar (328, 328') that can be radially inwardly compressed when one of the longitudinal sides (142, 142'; 148, 148') of the activating member arm (141, 144) slides on the flexible crossbar (328, 328').

8. The drug delivery device (100) of claim 7, wherein the flexible crossbars (328, 328') are blocking elements that bend radially outward when the first elastic member (24) of the rear assembly (3) causes drug discharge, thereby causing the activation member (14) to be displaced axially in a proximal direction, wherein the flexible crossbars (328, 328') bend radially outward when the distal portions (146, 146') of the activation member arms (141, 144) disengage and release the flexible crossbars (328, 328'); wherein the flexible crossbars (328, 328') provide an abutment surface for the distal portions (146, 146') to prevent the activation member (14) from moving distally.

9. The drug delivery device (100) as described in any one of claims 1-6, wherein the support and holding mechanism for the feedback member (18) and the plunger rod (34) includes an actuator (35) having one or more engagement members (338, 338') configured to engage with engagement members (128, 128') of the rear cap (12, 12').

10. The drug delivery device (100) of claim 9, wherein the engagement member (128) of the rear cap has a flexible crossbar with an inclined proximal edge (129) configured to guide the flexible crossbar into the housing (10) during assembly.

11. The drug delivery device (100) of claim 10, wherein the engaging member (338) of the actuator defines a recess on at least one longitudinal protrusion arranged along the outer surface of the actuator (35), wherein, when the rear cap is assembled, the engaging member (128) of the rear cap has a complementary mating shape to fit into the recess and securely hold the rear cap (12) in place, wherein the recess has a hook for holding the engaging member (128) of the rear cap in a locked state, so that once assembled, the rear cap is non-removable.

12. The drug delivery device (100) of claim 9, wherein the engagement member (338') of the actuator has a flexible arm, the flexible arm further comprising a hook (338'a) configured to engage with the engagement member (128') of the rear cap.

13. The drug delivery device (100) of claim 11, wherein the actuator (35) further comprises at least one locking element (351, 351') in the form of a protrusion extending radially inward along the inner surface of the actuator (35), the locking element (351, 351') abutting against the bottom of a support recess (337) formed by two side arms of the distal portion (335) of the support structure (33), wherein the locking element (351, 351') is engaged by fitting within the width of the recess (337) to prevent the feedback member (18) from moving distally and to prevent rotational movement of the support structure (33).

14. The drug delivery device (100) of claim 11, wherein the actuator (35) further comprises at least one engagement member (352, 352') in the form of a radially inwardly extending protrusion, the at least one engagement member in the form of a radially inwardly extending protrusion being configured to engage with a corresponding recess (339, 339') disposed on the outer surface of the support structure (33, 33'), wherein during assembly, the support structure (33, 33') slides within the tubular actuator (35) from proximal to distal direction until at least one engagement member (352, 352') in the form of a radially inwardly extending protrusion bends into the corresponding recess (339, 339'), thereby preventing any further movement of the support structure (33, 33') in the distal direction.

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