Device body for drug delivery device, assembly for drug delivery device, and drug delivery device

Abstract

The present disclosure provides a device body for a drug delivery device. The device body includes a needle shield positioning structure configured to fasten a needle shield against axial movement relative to the device body by interacting with at least one corresponding fastening feature of the needle shield when the needle shield of the drug delivery device is in a needle shield position relative to the device body. The device body has a proximal end and a distal end. In the needle shield position, the needle shield projects distally beyond the device body. The device body further includes a first needle shield safety structure configured and arranged to prevent separation of the fastening feature from the needle shield positioning structure by interaction with an outer surface of the needle shield when a portion of the device body where the needle shield positioning structure is arranged is deformed.

Description

Background Art

[0001] Drug delivery devices provide a convenient option for injecting drugs to a user / patient. For example, compared to conventional syringes, drug delivery devices are safer in avoiding human errors. Due to increasing demand, handheld drug delivery devices need to be mass-produced. Reducing manufacturing costs and increasing manufacturing speed are ongoing challenges, where user safety plays an important role. Summary of the Invention

[0002] This disclosure relates to a device body for a drug delivery device. Further, this disclosure relates to a component for a drug delivery device, the component including the device body. Further, this disclosure relates to a drug delivery device, the drug delivery device including the device body or the component.

[0003] The object of this disclosure is to provide a device body for a drug delivery device, a component for a drug delivery device, and / or a drug delivery device that are easy and / or comfortable to use, and / or include as few parts as possible.

[0004] This object is solved by the device body according to claim 1, the component according to claim 17, and the drug delivery device according to claim 18. Further aspects are described in the dependent claims.

[0005] According to an embodiment, a device body for a drug delivery device is provided. The device body includes a needle shield positioning structure configured to fasten a needle shield against axial movement relative to the device body by interacting with at least one corresponding fastening feature of the needle shield when the needle shield of the drug delivery device is in a needle shield position (e.g., a first needle shield position or a final needle shield position) relative to the device body. The device body includes a proximal end and a distal end. In the needle shield position, the needle shield projects distally beyond the device body, e.g., projects beyond the distal end of the device body in the distal direction. The device body further includes a first needle shield safety structure configured and arranged to prevent separation of the fastening feature from the needle shield positioning structure by interacting with the outer surface of the needle shield when a portion of the device body provided with the needle shield positioning structure is deformed.

[0006] The needle shield positioning structure may include a needle shield locking structure. Alternatively or additionally, the needle shield positioning structure may include a needle shield front stop.

[0007] The fastening feature may include at least one flexible arm (blocking means) of the needle shield. The at least one flexible arm may include one or more protrusions. The one or more protrusions may protrude in a radially outward direction. Preferably, the fastening feature includes at least two flexible arms. The flexible arms may be distributed on the outer circumference of the needle shield with an angular offset of 180 degrees. In one embodiment, the fastening feature may include more than two flexible arms, which are preferably evenly distributed around the circumference of the needle shield.

[0008] The at least one flexible arm may be configured to be pre-tensioned such that when the needle shield is inside the device body, the at least one flexible arm is not in a fully relaxed state. In other words, the at least one flexible arm may be configured to apply a radially outward force to any component in contact with its radially outwardly oriented surface (such as one or more protrusions) when the needle shield is inside the device body. This can help ensure a firm contact between the at least one flexible arm and other components of the device (such as the needle shield positioning structure). Alternatively or additionally, the fastening feature may include at least one front stop groove of the needle shield.

[0009] In one embodiment, the needle shield locking structure may be configured to interact with the at least one flexible arm. Alternatively or additionally, the needle shield front stop may be configured to interact with the front stop groove of the needle shield.

[0010] The first needle shield safety structure may include a needle shield locking anti-disengagement structure.

[0011] In one embodiment, the first needle shield safety structure may include a protrusion extending radially inward from the inner surface of the device body, such as from the inner surface of the side wall of the device body. The radially inward extension amount of the protrusion may decrease in the proximal direction along the axial extension amount of the protrusion.

[0012] In one embodiment, the first needle shield safety structure may extend in the axial direction of the device body, such as in the proximal direction from the proximal end of the needle shield positioning structure.

[0013] In one embodiment, the first needle shield safety structure may be configured to support the needle shield by restricting the radial movement of the outer surface of the needle shield relative to the inner surface of the device body. For example, the first needle shield safety structure may restrict the radial movement of at least a portion of the needle shield relative to the inner surface of the device body. This portion of the needle shield may be the portion where the fastening feature of the needle shield is arranged.

[0014] In one embodiment, the first needle shield safety structure may be formed by the inner surface of the device body, such as by the inner surface of the side wall of the device body.

[0015] In one embodiment, the outer surface of the needle shield can be the outer surface of the side region of the needle shield. The first needle shield safety structure can be arranged to interact with the outer surface of the side region such that at least a part of the circumferential extension of the side region, preferably the entire circumferential extension of the side region, is radially supported. Preferably, the first needle shield safety structure can be configured to interact with the side region in a suitable manner such that the force transmission of the contact force to the side region is at least non-eccentric, preferably uniform, on the axial and / or circumferential extension of the side region or at least a part of the axial and / or circumferential extension of the side region.

[0016] The deformable part of the device body can be the distal part of the device body. The distal part can be offset distally relative to the drug window of the device body. Alternatively, when arranged in its most distal position relative to the device body, the distal part can be offset distally relative to the proximal end of the syringe barrel. Alternatively, the distal part can be distal to the needle shield front stop.

[0017] The needle shield positioning structure can include at least one, at least two or at least four protrusions (such as ribs) extending in a radially inward direction from the side wall of the device body. The needle shield positioning structure can include at least one, at least two or at least four ramp-like structures that are radially inwardly inclined in the distal direction. The needle shield positioning structure can be formed in the distal half of the device body.

[0018] In one embodiment, the protrusions (such as ramp-like structures) can be arranged equidistantly in the circumferential direction of the device body. Alternatively, there can be different angular offsets between the protrusions or ramp-like structures. If the difference in angular offsets is large, two or more protrusions can be grouped together. In one embodiment, the groups of protrusions can be arranged equidistantly in the circumferential direction. For example, a group of two ramp-like structures can be angularly offset by 180 degrees in the circumferential direction from another group of two ramp-like structures.

[0019] In one embodiment, the device body can include at least one proximal stop structure that defines the maximum proximal position of the needle shield relative to the device body. The proximal stop structure can be configured to interact with the rear stop feature of the needle shield when the needle shield moves proximally relative to the device body. The proximal stop structure can include a needle shield rear stop. The needle shield rear stop can include four ribs extending in a radially inward direction from the side wall of the device body. The angular offset between these ribs can be between 30 degrees and 150 degrees. The rear stop feature of the needle shield can be formed by the proximal-facing surface between the side region of the needle shield and the flexible arm.

[0020] The device body may further include a central support structure configured to support a drug container. The drug container may be a pre-filled syringe. Alternatively or additionally, the central support structure may be configured to support a container holder. The container holder may be a syringe holder, for example for a pre-filled syringe.

[0021] The central support structure may include an axially supporting front end configured to prevent the drug container and / or the container holder from moving distally relative to the device body. The axially supporting front end may be formed at the distal end of the central support structure. The axially supporting front end may be configured to interact with the distal end of the drug container or the distal end of the container holder.

[0022] In one embodiment, the axially supporting front end may have a closed circumference. The axially supporting front end may include a radially inwardly projecting portion. The projecting portion may be configured to interact with the shoulder of the drug container. Alternatively or additionally, the projecting portion may be configured to interact with the flexible arm of the container holder. The diameter of the inner surface of the axially supporting front end may decrease in the distal direction. Thus, the inner surface of the axially supporting front end may form a cone. This may be advantageous when a container holder having a flexible distal end (such as a flexible holder arm) is inserted and connected to the device body. The narrowing cross-section of the cone may provide radially outward support to the distal end of the container holder. In one embodiment, the axially supporting front end may deflect the flexible holder arm radially inwardly, which improves the connection between the drug container and the container holder.

[0023] The central support structure may be connected to the side wall of the device body via at least one, preferably at least four connecting elements. The connecting elements may be connecting ribs. The connecting elements may extend in the radial direction.

[0024] The connecting elements may extend along at least 50% of the axial length of the central support structure. In one embodiment, the connecting elements may extend along at least 75%, preferably at least 90% of the axial length of the central support member. A longer axial extension may be advantageous as the stability of the central support structure may be improved due to better support at the side wall.

[0025] The radially inward portion of the connecting element may be shorter in the axial direction than the radially outward portion of the connecting element. Thus, at least the distal surface of the radially outward portion may project distally beyond the distal surface of the radially inward portion.

[0026] The radially inward portion can be the section of the connecting rib that is connected to the central support structure. In other words, the radially inward portion can be the section of the connecting rib that is radially more inward than the section that is connected to the inner surface of the sidewall (i.e., the radially outward portion). In other words, the radially outward portion is the outer section of the connecting rib where the connecting rib is connected to the inner surface of the sidewall of the device body.

[0027] In one embodiment, the device body may further include a holder guiding structure. The holder guiding structure may include at least one holder guiding rib, preferably at least four holder guiding ribs. The holder guiding structure may be configured to interact with the container holder of the drug delivery device and / or the body closure. In particular, the holder guiding structure may restrict rotational movement of the container holder and / or the body closure relative to the device body.

[0028] The container holder may be a syringe holder. The body closure may be a drive spring holder. The holder guiding structure may be configured to interact with the container holder during and / or after assembling the container holder to the device body. Similarly, the holder guiding structure may be configured to interact with the body closure during and / or after assembling the body closure to the device body.

[0029] In one embodiment, the device body may further include a needle shield anti-rotation structure configured to prevent the needle shield from rotating relative to the device body by interacting with the anti-rotation feature of the needle shield when the needle shield is connected to the device body (e.g., assembled in the device body). The anti-rotation feature of the needle shield may be formed by at least one, preferably several or all, of the edges of one or more side regions of the needle shield.

[0030] The needle shield anti-rotation structure may include at least one protrusion extending in the circumferential direction from at least one of the connecting elements, such as a needle shield guiding rib. The protrusion may further extend in the radial direction. The protrusion may further extend in the axial direction, thereby forming an anti-rotation surface for interacting with the anti-rotation feature of the needle shield.

[0031] In one embodiment, the device body may further include a second needle shield safety structure configured to prevent the anti-rotation feature from disengaging from the anti-rotation structure. For example, the second needle shield safety structure may be configured to interact with the inner surface of the needle shield. The inner surface of the needle shield may be the inner surface of the side region of the needle shield. The interaction may be enhanced by deformation of the portion of the device body where the needle shield positioning structure is arranged (e.g., when the device body is squeezed due to the device body falling or being squeezed by the user / patient).

[0032] The second needle shield safety structure may include a needle shield radial support rib that extends radially outward from the central support structure. The second needle shield safety structure may be arranged to be offset circumferentially relative to the first needle shield safety structure by less than 45 degrees, preferably less than 10 degrees. The second needle shield safety structure may at least partially, preferably completely, overlap the first needle shield safety structure in the axial direction. Alternatively or additionally, the second needle shield safety structure may at least partially, preferably completely, overlap the needle shield anti-rotation feature in the axial direction. The smaller angular offset and / or axial overlap may facilitate supporting the side regions of the needle shield against disengagement from the device body.

[0033] In one embodiment, the first needle shield safety structure may extend distally beyond the needle shield anti-rotation structure and / or the second needle shield safety structure.

[0034] In one embodiment, the device body may further include a cap anti-rotation structure configured to prevent the cap from rotating relative to the device body when the cap of the drug delivery device is connected to (e.g., assembled with) the device body. The cap anti-rotation structure may interact with a corresponding cap feature. The cap anti-rotation structure may include one or more cap grooves. The cap grooves may be formed in the inner surface of the side wall of the device body. The cap grooves may extend proximally from the distal end of the inner surface. In one embodiment, there may be four cap grooves arranged along the inner surface of the side wall with different angular offsets therebetween. Alternatively, the cap grooves may be arranged equidistantly in the circumferential direction.

[0035] According to an embodiment of the present disclosure, there is provided a component for a drug delivery device. The component includes a device body according to one of the foregoing embodiments. Further, the component includes a needle shield. Preferably, the component may include a needle shield spring.

[0036] Alternatively or additionally, the component may include one or more of a cap, a gripper, and / or a container holder (such as a syringe holder).

[0037] According to an embodiment of the present disclosure, there is provided a drug delivery device. The drug delivery device includes a device body according to one of the foregoing embodiments. Alternatively or additionally, the drug delivery device includes a component according to one of the foregoing embodiments. The drug delivery device may further include a drug container containing a drug. The drug container may be a pre-filled syringe.

[0038] Additional details regarding the features mentioned will be explained below in connection with the accompanying drawings. Additionally, details regarding the assembly of the drug delivery device or its parts and sub-assemblies will also be explained below in connection with the accompanying drawings.

[0039] According to another aspect, there is provided a method of delivering a medicament from a medicament delivery device, the method comprising using a medicament delivery device according to the present disclosure, such as according to any one of the above-described embodiments.

[0040] According to another aspect, there is provided a medicament for use in a method of treating a patient, wherein the method comprises using a medicament delivery device according to the present disclosure, such as according to any one of the above-described embodiments, to deliver the medicament to the patient.

[0041] The fabrication and use of presently preferred embodiments are discussed in detail below. However, it should be understood that the present disclosure provides many applicable concepts that can be implemented in a variety of specific environments. The specific embodiments discussed merely illustrate specific ways of fabricating and using the disclosed concepts and do not limit the scope of the claims.

[0042] Furthermore, unless otherwise specified, the same reference numerals refer to the same technical features. With respect to the use of "can" and "may" in the present application, it indicates the possibility of doing so as well as the actual technical implementation. The present concepts of the present disclosure will be described below in a more specific context, namely a medicament delivery device, particularly a medicament delivery device for humans or animals. However, the disclosed concepts can also be applied to other situations and / or arrangements, such as other syringes, spray devices or inhalation devices.

[0043] The features and technical advantages of the embodiments of the present disclosure have been outlined quite broadly above. Additional features and advantages of the embodiments of the present disclosure will be described below (e.g., the subject matter of the dependent claims). Those skilled in the art should understand that the disclosed concepts and specific embodiments can be readily used as a basis for modifying or designing other structures or processes for achieving the same or similar purposes as the concepts specifically discussed herein. Those skilled in the art should also recognize that equivalent structures do not depart from the spirit and scope of the present disclosure as defined, for example, in the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] To more fully understand the present concepts disclosed and their advantages, reference is now made to the following description taken in conjunction with the accompanying drawings. The drawings are not drawn to scale. In the drawings:

[0045] Figures 1A to 1D A cross-section of a medicament delivery device according to a first embodiment and in different operating states is shown,

[0046] Figure 2 An exploded view of an example of a medicament delivery device without or with an optional separate syringe holder is shown,

[0047] FIG. 3A to FIG. 3I An optional cap and an optional cap cover are shown, and

[0048] Figure 4A and Figure 4B respectively show a perspective view of an optional gripper and a cross-section of the gripper,

[0049] Figure 4C showing an exemplary embodiment of a single-piece sheet that can form a gripper support,

[0050] Figure 4D and Figure 4E show a gripper in an engaged position with a needle shield of a syringe barrel,

[0051] Figure 4F showing a cross-sectional view of the gripper of the previous embodiment assembled within a cap,

[0052] Figure 4G detailedly showing the interaction between a gripper retaining boss (such as a boss of the cap) and an opening of an exemplary gripper,

[0053] Figure 4H showing a cross-section of the front end of an injection device on which a cap and a gripper mounted on the cap and interacting with the needle shield are installed,

[0054] Figure 5 showing an optional needle shield (needle cannula),

[0055] Fig. 6A showing a needle shield spring,

[0056] Figure 6B showing a cross-sectional view of a needle shield spring assembled within a drug delivery device in a pre-use state of the drug delivery device,

[0057] Fig. 7A showing the device body,

[0058] Figure 7B showing a cross-sectional view of the device body,

[0059] Figure 7C showing a perspective cross-sectional view of the distal end of the device body,

[0060] Fig.7D showing a cross-sectional view of the central portion of the device body with a syringe barrel holder,

[0061] Fig. 7E showing a perspective view of the syringe barrel holder front stop of the device body,

[0062] Figure 7F showing a cross-sectional view of the distal end of the device body where the needle shield is in a third shield position,

[0063] Figure 7GShows a perspective view of the interaction between the needle shield locking structure and the flexible arm of the needle shield,

[0064] Fig. 8A Shows an optional syringe holder,

[0065] Figure 8B Shows a perspective view of the optional syringe holder,

[0066] Figure 8C Shows a detailed view of another exemplary embodiment of the flexible holder arm,

[0067] Fig.8D Shows an optional syringe holder including Figure 8C the flexible holder arm,

[0068] Fig. 9 Shows an optional prefilled syringe,

[0069] Fig.10 Shows the plunger,

[0070] Fig. 10A Shows the plunger release mechanism in the first state,

[0071] Fig. 10B Shows the plunger release mechanism in the second state,

[0072] Fig. 10C Shows the plunger release mechanism during the assembly of the drive subassembly,

[0073] Fig. 10D Shows the plunger release mechanism during the final assembly,

[0074] Fig.10E Shows another state of the plunger release mechanism,

[0075] Fig.10F Shows a schematic view of the plunger release mechanism after the sleeve is pressed into the retracted position,

[0076] Figure 10G Shows a schematic detailed view of the plunger release mechanism after the final assembly and before the sleeve is pressed in,

[0077] Fig. 10H Shows a schematic detailed view of the plunger release mechanism during the pressing of the sleeve,

[0078] Fig.10I Shows a longitudinal rib on the inner side of the rigid arm of the drive spring holder,

[0079] Fig.10J Shows a perspective view of the plunger according to the second embodiment,

[0080] Figure 10K Shows a distal view of the plunger according to the second embodiment,

[0081] Fig.10L shows a cross-section of the shaft of the plunger along the radial direction according to the second embodiment

[0082] Figure 10M shows a cross-section of the shaft of the plunger along the longitudinal direction.

[0083] Fig.11A shows the drive spring according to an embodiment of the present disclosure,

[0084] Fig. 11B shows the drive spring assembled in the drug delivery device during actuation of the plunger Fig.11A of

[0085] Fig. 11C shows the drive spring assembled in the drug delivery device before actuation of the plunger Fig.11A and Fig. 11B of

[0086] Fig. 12A and Fig. 12B shows a perspective view of the drive spring holder,

[0087] Fig. 12C shows the syringe rear stop mechanism,

[0088] Fig.12D shows a cross-sectional view of the proximal portion of the drive spring holder,

[0089] FIG. 12E to FIG. 12G shows different embodiments of the flexible portion of the drive spring holder,

[0090] Fig.13A shows an optional auditory indicator (rattle),

[0091] Fig. 13B shows an indicator holder exemplary included on the drive spring holder,

[0092] Fig. 13C shows a perspective view of the support structure on the distal end of the flexible support arm,

[0093] Fig.13D shows a perspective view of the guiding structure of the indicator holder,

[0094] Fig.13E shows a cross-section through the longitudinal symmetry axis of the indicator holder,

[0095] Fig.13F shows the rear sub-assembly (RSA) after assembly of the auditory indicator but before activation of the auditory indicator,

[0096] Figure 13G Shows the posterior subassembly (RSA) after activation of the auditory indicator (preferably using the activation tool).

[0097] Fig.13H Shows the activation tool.

[0098] Fig.13I Shows the state of the RSA and the anterior subassembly (FSA) during final assembly shortly before activation of the auditory indicator.

[0099] FIG. 14A to FIG. 14J Shows the steps for assembling an optional syringe holder and a pre-filled syringe into the device.

[0100] Fig.15A Shows a flowchart of an exemplary feedback sequence during use of the drug delivery device.

[0101] FIG. 15B to FIG. 15D Shows different views of the drug window during the dose dispensing process.

[0102] Fig.16 and Fig.17 Shows the posterior and anterior subassemblies of the drug delivery device, and

[0103] Figure 18 shows the expanded structural formula, molecular formula and molecular weight of fentosiran (e.g., in sodium form). Detailed Description

[0104] In general, "distal" is used herein to indicate a direction, end or surface that is arranged or to be arranged to face or point towards the dispensing end of the drug delivery device and / or away from, to be arranged away from, or away from the proximal end. On the other hand, "proximal" is used to indicate a direction, end or surface that is arranged or to be arranged away from or facing away from the dispensing end of the drug delivery device or its components and / or the distal end. The distal end can be the end closest to the dispensing end and / or the farthest from the proximal end, and the proximal end can be the end farthest from the dispensing end. The proximal surface can face away from the distal end and / or towards the proximal end. The distal surface can face the distal end and / or away from the proximal end. For example, the dispensing end can be the needle end where the needle is arranged, or where the needle or needle unit is mounted or to be mounted to the device. "Axial" can be synonymous with "longitudinal".

[0105] The distal end DE can be the end closer to the needle compared to the proximal end PE.

[0106] Certain embodiments of the present disclosure are shown with respect to an injection device (e.g., an autoinjector). The device can include an advanced needle shield that serves as an enabling element.

[0107] 1. General description of the drug delivery device ( Figures 1A to 1D )

[0108] Figures 1A to 1D shows an embodiment of a drug delivery device 100. The device 100 may be suitable as a device in a drug delivery arrangement further described above and below. These figures show different states of the device 100 during its operation.

[0109] Figure 1A shows the drug delivery device 100 in an initial or out-of-factory state. The drug delivery device 100 may include a housing or device body 700. The device body 700 may be configured to and / or may hold a medicament container (such as a pre-filled syringe 900) therein. A medicament (such as a liquid medicament or drug Dr) may be arranged in the pre-filled syringe 900. It should be noted that the use of the term "pre-filled syringe 900" hereinafter does not limit the design of the container to a pre-filled syringe. Rather, containers other than pre-filled syringes may also be considered for implementation. The device body 700 may be configured to hold and / or may hold a needle 908, see Figure 1C . In other words, the needle 908 may be arranged or may be arranged in the device body 700. The needle 908 may be an integral part of the pre-filled syringe 900 or container (such as permanently or releasably connected to the body of the medicament container), or separate from the medicament container. In the first case, the medicament container may be a syringe. In the second case, the medicament container may be a cartridge. In the case of using a cartridge as the medicament container, initially, the medicament container and the needle may be fluidly disconnected, and fluid communication between the interior of the medicament container and the needle 908 is established only during the operation of the drug delivery device 100. An optional medicament container holder, such as a syringe holder 800, may be used to support and / or carry the medicament container within the device body 700.

[0110] A drive mechanism 101 configured to drive a drug delivery operation may be appropriately provided in the device body 700. The drive mechanism 101 may include a plunger 1000. The drug delivery device 100 may further include a drive energy source, such as a drive spring 1100, such as a compression spring (not explicitly shown). The drive energy source may be arranged to drive the plunger 1000 in a distal direction D relative to the medicament container during a drug delivery operation. During this movement, a plunger stopper 910 that may be movably held in the medicament container (i.e., the pre-filled syringe 900) and may seal the medicament container may be displaced towards the outlet of the medicament in the medicament container to dispense the drug Dr or medicament held within the medicament container through the outlet. The outlet may be formed or defined by the needle 908, see Figure 1C .

[0111] Other possible drive energy sources different from the drive spring 1100 include a power cell or battery for driving the plunger 1000 via an electric motor, or (where gas pressure can be used to drive the drug delivery operation) a reservoir suitable for providing gas pressure.

[0112] The drug delivery device 100 can be an autoinjector. The energy for driving the drug delivery operation in the autoinjector can be provided by the components of the drug delivery device 100, rather than being loaded into the device 100 by the user during the operation of the device 100 as in many spring-driven pen-type variable dose syringes where, typically, the energy is loaded into the spring by the user during the dose setting procedure.

[0113] The drug delivery device 100 can suitably be a single-shot device, i.e., it is arranged to dispense only one dose. The drug delivery device 100 can be a disposable drug delivery device 100, that is, a device 100 that is discarded after its use. The device 100 can be a pen-type device. The prefilled syringe barrel 900 and / or the needle 908 can be axially fastened within the drug delivery device 100 (e.g., within the device body 700), or can be movable relative to the device body 700 (e.g., to pierce the skin). In the first case, the user may have to perform the movement of piercing the skin with the needle 908. In the second case, piercing the skin by the needle 908 can be driven by the needle insertion mechanism of the drug delivery device 100. Automatic needle retraction can also be used.

[0114] As Figure 1A depicted, the drug delivery device 100 can further include a cap 200. The cap 200 can be arranged at the distal end DE of the drug delivery device 100. The cap 200 can be detachably connected to the rest of the device 100, e.g., to the device body 700 and / or another part or component of the drug delivery device 100. The cap 200 can cover the distal end DE of the rest of the drug delivery device 100 and / or the needle channel opening through which the needle 908 (e.g., the distal needle tip) can project to pierce the skin for the drug delivery operation. The cap 200 can include a needle shield remover, such as a gripper 400, which can engage a rigid needle shield (RNS) 914 that can cover the needle 908 such that, for example, when the cap 200 is separated or disconnected from the device 100, the RNS 914 is removed from the needle 908 together with the cap 200.

[0115] The device body 700 can suitably cover most of the length of the drug delivery device 100, e.g., 60% or more or 70% or more of the entire length of the drug delivery device 100 (in the case where the cap 200 is attached and / or in the case where the cap 200 is removed).

[0116] Figure 1B shows the drug delivery device 100 with the cap 200 removed. According to Figure 1B , the device 100 can be in a state ready for operation, for example, a state ready to perform a drug delivery operation when the operation is triggered. As depicted, the drug delivery device 100 can further include a needle shield 500. The needle shield 500 can project distally from the device body 700 and / or can have been covered by the cap 200 when the cap 200 was still attached to the device body 700. The needle shield 500 can move relative to the device body 700 from an initial or first position to a second or triggering position. The needle shield 500 can be arranged to extend beyond the distal end of the needle 908, which can project from the device body 700 before the start of the drug delivery operation. The needle shield 500 can move in the proximal direction P relative to the housing 102. During this movement, for example, before the needle shield 500 reaches the second position, the needle 908 can pierce the user's skin.

[0117] The needle shield 500 can serve as a trigger member of the drug delivery device 100. The needle shield 500 as a trigger member, when displaced proximally from Figure 1B the depicted initial or first position to the second or triggering position (see Figure 1C ), preferably when it is in the second position, can automatically initialize the drug delivery operation. The drug delivery operation can be initialized by the moving needle shield 500 by removing a mechanical lock that prevents the plunger 1000 from moving in the distal direction D or by moving the plunger 1000 to unlock the mechanical lock. Alternatively, the needle shield 500 can only be able to trigger the drug delivery operation when moving from the first position to the second position and appropriately when in the second position. In this case, a separate trigger member (e.g., a trigger button on the proximal end PE of the device body 700) can be provided to initiate the drug delivery operation. The trigger button can only be operated to initiate the drug delivery operation when the needle shield 500 is in the second position. In yet another alternative, the needle shield 500 can be arranged only to prevent needle stick injuries before and / or after using the drug delivery device 100. In this case, the needle shield 500 can be completely decoupled from the drive mechanism 101 and / or can not participate at all in triggering the drug delivery operation or effecting the triggering of the drug delivery operation.

[0118] The needle shield 500 can be configured to abut against the user's skin during injection. Accordingly, the distal surface of the needle shield 500 can provide a support surface or skin contact surface 501. The skin contact surface 501 can define and / or extend around a needle channel opening disposed in the needle shield 500. The skin contact surface 501 can be annular, oval, elliptical, rectangular, square, etc., circumferentially enclosed and / or defined by inward protrusions that radially project from the inner wall of the needle shield 500 (e.g., its distal cylindrical portion). The skin contact surface 501 can suitably be the distal surface of the needle shield 500, e.g., facing distally. A syringe with a needle can be axially fixed in the device. Insertion of the needle into the skin is suitably done manually rather than by displacing the syringe relative to the device body 700.

[0119] Figure 1C The needle shield 500 is shown in a second position relative to the device body. For example, this is the position when a drug delivery operation has been initiated, can be initiated, and / or when the needle 908 pierces the skin. The needle 908 can axially project from the skin contact surface 501 of the drug delivery device 100 (specifically through the needle channel opening in the needle shield 500) and pierce the skin by the distance by which it projects beyond the skin contact surface 501 (the skin is not shown in this representation). This distance can be representative of or equal to the injection depth. The device 100 can be maintained in contact with the skin until the drug delivery operation of the drug Dr has been completed, which can be indicated by optional audible, tactile, and / or visual indications or feedback provided by the drug delivery device 100.

[0120] After the drug delivery operation has been completed (e.g., the plunger 1000 has been moved distally), the device 100 can be removed from the skin (see Figure 1D ). The needle shield 500 can be biased relative to the device body 700 towards a first position by a needle shield spring 600 (not shown). Accordingly, when the device 100 is removed from the skin, the needle shield 500 can move relative to the device body 700 towards the first position. The needle shield 500 can move distally (e.g., beyond its first position) into a final position, third position, or locked position relative to the device body 700. In this position, the needle shield 500 can suitably be axially locked relative to the device body 700 against movement in the proximal direction P, e.g., by a locking engagement between a locking feature of the needle shield 500 and the device body 700. Since the needle shield 500 is axially locked, the needle shield can no longer be displaced proximally relative to the device body 700 to the second position and / or the first position. This can protect the user from needle stick injuries after use. In this state, the device 100 can be locked, see Figure 1D . The needle shield can project further from the device body when in the third shield position Z than when in the first shield position X.

[0121] Drug list

[0122] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation that includes one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on a human or animal. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose a disease or to otherwise enhance physical or mental health. A drug or medicament can be used for a limited duration or regularly for a chronic disorder.

[0123] As described below, a drug or medicament can include at least one API or a combination thereof in different types of formulations for treating one or more diseases. Examples of APIs can 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-stranded 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 can be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). A mixture of one or more drugs is also contemplated.

[0124] A drug or medicament can be contained in a primary package or "drug container" suitable for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe barrel, reservoir, or other rigid or flexible vessel that is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber can be designed to store the drug for about 1 month to about 2 years. Storage can be at room temperature (e.g., about 20 °C) or at refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or can include a dual-chamber cartridge that is configured to separately store two or more components of a pharmaceutical preparation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dispensing into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a conduit between the two chambers) and allow a user to mix the two components when needed before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when the components are dispensed into a human or animal body.

[0125] The medicaments or agents contained in a drug delivery device as described herein can be used for treating and / or preventing many different types of medical disorders. Examples of disorders include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic disorders (such as deep vein or pulmonary thromboembolism). Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, tumors, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following compendia: such as the Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and the Merck Index, 15th edition.

[0126] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or diabetes-related complications of type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or their analogs or derivatives; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture of the above. As used herein, the terms “analog” and “derivative” refer to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be encoded amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. In particular, the term “derivative” refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encoded amino acids), or amino acids (including non-encoded amino acids) have been added to the naturally occurring peptide.

[0127] Examples of insulin analogs are 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, where the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and where the Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28 - B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0128] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, ); 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 - γ - glutamyl) - des(B30) human insulin, B29 - N - ω - carboxypentadecanoyl - γ - L - glutamyl - des(B30) human insulin (insulin degludec, ); B29 - N - (N - lithocholyl - γ - glutamyl) - des(B30) human insulin; B29 - N - (ω - carboxyheptadecanoyl) - des(B30) human insulin and B29 - N - (ω - carboxyheptadecanoyl) human insulin.

[0129] Examples of GLP - 1, GLP - 1 analogs and GLP - 1 receptor agonists are, for example, lixisenatide exenatide (Exendin - 4, a 39 - amino acid peptide produced by the salivary glands of the Gila monster), liraglutide semaglutide, taspoglutide, albiglutide dulaglutide 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-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN, and Glucagon-Xten.

[0130] Examples of oligonucleotides are, for example: mipomersen sodium A cholesterol-reducing antisense therapeutic agent for treating familial hypercholesterolemia or RG012 for treating Alport syndrome.

[0131] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, degliptin, saxagliptin, berberine.

[0132] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, gonadotropin), somatotropin (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0133] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides (e.g., the polysulfated forms of the above polysaccharides), and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 A sodium hyaluronate.

[0134] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized antibody or a humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the ability of the antibody to bind to Fc receptors is reduced or there is no such ability. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, its Fc receptor binding region has been mutated or deleted. The term "antibody" also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0135] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide that can bind to an antigen. Antibody fragments may include cleavage portions of full-length antibody polypeptides, but the term is not limited to such cleavage fragments. Antibody fragments that can be used 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 antibodies, trivalent antibodies, tetravalent antibodies and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or biabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies containing VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0136] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "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 the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is typically not directly involved in antigen binding as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0137] Examples of antibodies are anti-PCSK-9 mAb (eg, alirocumab), anti-IL-6 mAb (eg, salilumab), and anti-IL-4 mAb (eg, dupilumab).

[0138] Further examples of APIs for preventing hemophilia A or B (with or without inhibitors) include siRNAs targeting antithrombin. An example of an siRNA targeting antithrombin is fetocillin. The terms "prevention" and "prophylactic treatment" are used interchangeably herein.

[0139] 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.

[0140] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components, formulations, apparatuses, methods, systems and embodiments of the API described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

[0141] 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 can be broadly divided into multi-dose container systems and single-dose (partially or completely emptied) container systems. The container may be a replaceable container or an integral non-replaceable container.

[0142] As further described in ISO 11608-1:2014(E), a multiple-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user). Another multiple-dose container system may involve a needle-based injection device with an integral non-replaceable container. In such a system, each container contains multiple doses, the sizes of which may be fixed or variable (pre-set by the user).

[0143] As further described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with a replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied). Also as described in ISO 11608-1:2014 (E), a single dose container system can relate to an injection device based on a needle with an integral non-replaceable container. In an example of such a system, each container holds a single dose, wherein the entire deliverable volume is discharged (completely emptied). In another example, each container holds a single dose, wherein a portion of the deliverable volume is discharged (partially emptied).

[0144] Fetocilan as API for drug delivery in device

[0145] Fetosilan is a synthetic, chemically modified, double-stranded small interfering RNA (siRNA) oligonucleotide that is covalently linked to a triantennary N-acetyl-galactosamine (GalNAc) ligand that targets AT3 mRNA in the liver, thereby inhibiting the synthesis of antithrombin. See, e.g., Pasi et al., N Engl J Med. [New England Journal of Medicine] (2017) 377 (9): 819-28. The nucleosides in each chain of Fetosilan are linked by 3'-5' phosphodiester or phosphorothioate linkages to form the sugar-phosphate backbone of the oligonucleotide.

[0146] The sense strand and antisense strand contain 21 and 23 nucleotides, respectively. The 3' end of the sense strand is conjugated to a GalNAc-containing portion (referred to herein as L96) by a phosphodiester linkage. The sense strand contains two continuous thiophosphate linkages at its 5' end. The antisense strand contains four thiophosphate linkages, two at the 3' end and two at the 5' end. The 21 nucleotides of the sense strand are hybridized with the complementary 21 nucleotides of the antisense strand, thus forming 21 nucleotide base pairs and two bases at the 3' end of the antisense strand. See also U.S. Patent No. 9,127,274, U.S. Patent No. 11,091,759, US2020 / 0163987A1 and WO 2019 / 014187, the entire contents of each of which are expressly incorporated herein by reference.

[0147] The two nucleotide chains of phenobarbital are shown below:

[0148] Sense strand: 5'Gf-ps-Gm-ps-Uf-Um-Af-Am-Cf-Am-Cf-Cf-Af-Um-Uf-Um-Af-Cm-Uf-Um-Cf-Am-Af-L96 3' (SEQ ID NO: 1), and

[0149] Antisense strand: 5'Um-ps-Uf-ps-Gm-Af-Am-Gf-Um-Af-Am-Af-Um-Gm-Gm-Uf-Gm-Uf-Um-Af-Am-Cf-Cm-ps-Am-ps-Gm 3' (SEQ ID NO: 2),

[0150] in

[0151] Af = 2'-deoxy-2'-fluoroadenosine

[0152] Cf = 2'-deoxy-2'-fluorocytidine

[0153] Gf = 2'-deoxy-2'-fluoroguanosine

[0154] Uf = 2'-deoxy-2'-fluorouridine

[0155] Am=2'-O-methyladenosine

[0156] Cm=2'-O-methylcytidine

[0157] Gm=2'-O-methylguanosine

[0158] Um = 2'-O-methyluridine

[0159] "-" (hyphen) = 3'-5' phosphodiester linkage sodium salt

[0160] "-ps-" = 3'-5' phosphorothioate linkage sodium salt

[0161] And wherein L96 has the formula:

[0162]

[0163] As used herein, the terms "2'-deoxy-2'-fluoroadenosine" and "2'-fluoroadenosine" are used interchangeably.

[0164] As used herein, the terms "2'-deoxy-2'-fluorocytidine" and "2'-fluorocytidine" are used interchangeably.

[0165] As used herein, the terms "2'-deoxy-2'-fluoroguanosine" and "2'-fluoroguanosine" are used interchangeably.

[0166] As used herein, the terms "2'-deoxy-2'-fluorouridine" and "2'-fluorouridine" are used interchangeably.

[0167] The expanded structural formula, molecular formula, and molecular weight of notoxilan (e.g., the sodium form) are shown in FIG. 18.

[0168] The structure of notoxilan can also be described by the following figure, where X is O:

[0169]

[0170] Notoxilan is shown in FIG. 18 in the sodium salt form.

[0171] In some embodiments, the device delivers notoxilan in an aqueous solution, wherein the concentration of notoxilan is from about 40 mg / mL to about 200 mg / mL (e.g., from about 50 mg / mL to about 150 mg / mL, from about 80 mg / mL to about 110 mg / mL, or from about 90 mg / mL to about 110 mg / mL). As used herein, values between the stated ranges and values are also intended to be part of this disclosure. Additionally, ranges of values using any combination of the stated values as upper and / or lower limits are intended to be included. In additional embodiments, the pharmaceutical formulation comprises notoxilan at a concentration of about 40 mg / mL, about 50 mg / mL, about 75 mg / mL, about 100 mg / mL, about 125 mg / mL, about 150 mg / mL, or about 200 mg / mL in an aqueous solution. In certain embodiments, notoxilan is provided at a concentration of about 100 mg / mL in an aqueous solution.

[0172] The term “deliver / delivers / delivering” is intended to mean “administer / administers / administering”.

[0173] Unless specifically stated or otherwise apparent from the context, as used herein, the terms “about” or “approximately” refer to values within an acceptable error range of a particular value as determined by one of ordinary skill in the art, a portion of which will depend on how the value is measured or determined. For example, “about” or “approximately” can mean a range of up to 10% (i.e., ±10%). Thus, “about” or “approximately” can be understood to be greater than or less than 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, 0.01%, or 0.001%. When a specific value is provided in this disclosure, unless otherwise stated, the meaning of “about” or “approximately” should be assumed to be within the acceptable error range of that specific value.

[0174] Although the weight of the fetocillin dosage described herein refers to the weight of fetocillin free acid (active moiety), administration of fetocillin to a patient herein refers to administration of fetocillin sodium (drug substance) provided in a pharmaceutically suitable aqueous solution (e.g., phosphate buffered saline at physiological pH). For example, about 100 mg / mL fetocillin means that each mL contains about 100 mg of fetocillin free acid (equivalent to about 106 mg of fetocillin sodium, drug substance). Unless otherwise specified, the weight of fetocillin listed in this disclosure is the weight of fetocillin free acid (active moiety).

[0175] In some embodiments, the pharmaceutical preparation in the device comprises fetoxilan in phosphate buffered saline. The phosphate concentration in the solution can be about 1 to about 10mM (e.g., about 2mM, about 3mM, about 4mM, about 5mM, about 6mM, about 7mM, about 8mM, or about 9mM), and the pH is about 6.0-8.0. The pharmaceutical preparation herein can include a stabilizer, such as EDTA. The pharmaceutical preparation can be preservative-free. In some embodiments, the fetoxilan pharmaceutical preparation in the device is preservative-free, and each mL of about 5mM phosphate buffered saline (PBS) solution comprises about 100mg fetoxilan, is composed of or is substantially composed of about 100mg fetoxilan. In some embodiments, the fetoxilan pharmaceutical preparation in the device is preservative-free, and comprises fetoxilan in about 5mM phosphate buffered saline (PBS) solution, is composed of or is substantially composed of it. The PBS solution is composed of sodium chloride, disodium hydrogen phosphate (heptahydrate) and sodium dihydrogen phosphate (monohydrate). The pH of the formulation can be adjusted to about 7.0 or about 7.1 using sodium hydroxide solution and dilute phosphoric acid.

[0176] In some embodiments, the fetucillin formulation in the device for subcutaneous delivery contains fetucillin in 5 mM phosphate buffered saline at pH 7.0 with 0.64 mM NaH 2 PO 4 、4.36mM Na 2 HPO 4 and 84 mM NaCl. In certain embodiments, the formulation of the fetocillin solution for subcutaneous delivery is shown in Table 1 below:

[0177] Table 1. Exemplary non-toxilan formulations

[0178]

[0179] *Amount: Amount

[0180] In some embodiments, the formulation of a fetocillin solution for subcutaneous delivery with a device may be described as shown in Table 2 below.

[0181] Table 2. Exemplary non-toxilan formulations

[0182]

[0183] In some embodiments, the device can be used to deliver a single dose of fetocillin, wherein the single dose includes about 20 mg to about 80 mg of fetocillin (e.g., about 20 mg, about 25 mg, about 30 mg, about 40 mg, about 50 mg, or about 80 mg). In some embodiments, the device can be used to deliver a single dose of fetocillin, wherein the single dose includes about 1 mg to about 30 mg of fetocillin (e.g., about 1.25 mg, about 2.5 mg, about 5 mg, about 10 mg, about 20 mg, or about 30 mg).

[0184] In one embodiment, the device may be used to deliver a single dose of about 80 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 50 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 20 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 30 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 10 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 5 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 2.5 mg of fetucillin. In one embodiment, the device may be used to deliver a single dose of about 1.25 mg of fetucillin.

[0185] In some embodiments, a single dose of fetocillan can be delivered in a delivery volume of about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL). Other delivery volumes described herein can also be used.

[0186] In one embodiment, the device can be used to deliver a single dose of approximately 80 mg of fitusiran (approximately 100 mg of fitusiran / mL) in approximately 0.8 mL. In one embodiment, the device can be used to deliver a single dose of approximately 50 mg of fitusiran (approximately 100 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 20 mg of fitusiran (approximately 40 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 30 mg of fitusiran (approximately 60 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 10 mg of fitusiran (approximately 20 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 5 mg of fitusiran (approximately 10 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 2.5 mg of fitusiran (approximately 5 mg of fitusiran / mL) in approximately 0.5 mL. In one embodiment, the device can be used to deliver a single dose of approximately 1.25 mg of fitusiran (approximately 2.5 mg of fitusiran / mL) in approximately 0.5 mL.

[0187] In one embodiment, the device delivers fitusiran in a prophylactically effective amount for the prophylactic treatment of hemophilia (e.g., hemophilia A or B with or without inhibitors) in a patient in need thereof (e.g., a patient with hemophilia A or B with or without inhibitors). A "prophylactically effective amount" means an amount of fitusiran that helps a patient with hemophilia A or B (with or without inhibitors) achieve a desired clinical endpoint (such as reducing the annualized bleeding rate (ABR), the annualized joint bleeding rate (AjBR), the annualized spontaneous bleeding rate (AsBR), or the frequency of bleeding episodes). As used herein, in the context of fitusiran, the term "treat / treating / treatment" includes prophylactic treatment of a disease and refers to achieving a desired clinical endpoint.

[0188] A patient with hemophilia A or B with inhibitors is a patient who has developed an alloantibody against a factor that they have previously received (e.g., factor VIII for a patient with hemophilia A or factor IX for a patient with hemophilia B). Patients with hemophilia A or B with inhibitors may be difficult to treat with replacement coagulation factor therapy. A patient without inhibitors is a patient who does not have such an alloantibody. This treatment method may be beneficial for patients with hemophilia A with inhibitors and patients with hemophilia B with inhibitors.

[0189] As used herein, a patient with "hemophilia A or B (with or without inhibitor)" refers to either 1) a hemophilia A patient with an inhibitor, or 2) a hemophilia B patient with an inhibitor, 3) a hemophilia A patient without an inhibitor, or 4) a hemophilia B patient without an inhibitor. As used herein, a patient refers to a human patient. A patient may also refer to a human subject.

[0190] In some embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 50 mg of fitusiran subcutaneously every two months (or every eight weeks). In other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 50 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 80 mg of fitusiran subcutaneously every two months (or every eight weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 80 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 20 mg of fitusiran subcutaneously every two months (or every eight weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 20 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 10 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 30 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 5 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 2.5 mg of fitusiran subcutaneously every month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitor) with approximately 1.25 mg of fitusiran subcutaneously every month (or every four weeks).

[0191] Accordingly, the present invention provides a method for prophylactic treatment of patients with hemophilia A or hemophilia B (with or without inhibitors), the method comprising subcutaneous delivery of a prophylactically effective amount of fitusiran to a patient in need thereof using the device. The prophylactically effective amount of fitusiran can be any dose provided herein, such as from about 1 mg to about 80 mg, from about 1 mg to about 30 mg, or from about 20 mg to about 80 mg. The prophylactically effective amount of fitusiran can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran can be delivered once monthly (or every four weeks) or once every two months (or every eight weeks). The fitusiran can be delivered at a delivery volume of from about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0192] As an example, a method for prophylactic treatment of a patient with hemophilia A or hemophilia B (with or without inhibitors) can comprise subcutaneous delivery of about 50 mg of fitusiran to a patient in need thereof using the device once monthly (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0193] Furthermore, the present invention provides a method for reducing the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors), the method comprising subcutaneous delivery of a prophylactically effective amount of fitusiran to a patient in need thereof using the device. The prophylactically effective amount of fitusiran can be any dose provided herein, such as from about 1 mg to about 80 mg, from about 1 mg to about 30 mg, or from about 20 mg to about 80 mg. The prophylactically effective amount of fitusiran can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran can be delivered once monthly (or every four weeks) or once every two months (or every eight weeks). The fitusiran can be delivered at a delivery volume of from about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0194] As an example, a method for reducing the frequency of bleeding episodes in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneous delivery of about 50 mg of fitusiran to a patient in need thereof using the device once monthly (or every four weeks) or once every two months (or every eight weeks). The about 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0195] In addition, provided herein is a method of reducing ABR in a patient with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering to a patient in need a prophylactically effective amount of fitusiran using the device. The prophylactically effective amount of fitusiran can be any dose provided herein, such as from about 1 mg to about 80 mg, from about 1 mg to about 30 mg, or from about 20 mg to about 80 mg. The prophylactically effective amount of fitusiran can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran can be delivered once monthly (or every four weeks) or once every two months (or every eight weeks). Fitusiran can be delivered at a delivery volume of from about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0196] As an example, a method of reducing ABR in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneously delivering to a patient in need about 50 mg of fitusiran once monthly (or every four weeks) or once every two months (or every eight weeks) using the device. About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0197] In addition, provided herein is a method of reducing AjBR in a patient with hemophilia A or B (with or without inhibitors), the method comprising subcutaneously delivering to a patient in need a prophylactically effective amount of fitusiran using the device. The prophylactically effective amount of fitusiran can be any dose provided herein, such as from about 1 mg to about 80 mg, from about 1 mg to about 30 mg, or from about 20 mg to about 80 mg. The prophylactically effective amount of fitusiran can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran can be delivered once monthly (or every four weeks) or once every two months (or every eight weeks). Fitusiran can be delivered at a delivery volume of from about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0198] As an example, a method of reducing AjBR in a patient with hemophilia A or B (with or without inhibitors) can comprise subcutaneously delivering to a patient in need about 50 mg of fitusiran once monthly (or every four weeks) or once every two months (or every eight weeks) using the device. About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0199] In addition, the present disclosure provides a method for reducing AsBR in patients with hemophilia A or B (with or without inhibitors), the method comprising subcutaneous delivery of a prophylactically effective amount of fitusiran to a patient in need thereof using the device. The prophylactically effective amount of fitusiran can be any dose provided herein, such as from about 1 mg to about 80 mg, from about 1 mg to about 30 mg, or from about 20 mg to about 80 mg. The prophylactically effective amount of fitusiran can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The prophylactically effective amount of fitusiran can be delivered once monthly (or every four weeks) or once every two months (or every eight weeks). Fitusiran can be delivered at a delivery volume of from about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0200] As an example, the method for reducing AsBR in patients with hemophilia A or B (with or without inhibitors) can comprise subcutaneous delivery of about 50 mg of fitusiran to a patient in need thereof once monthly (or every four weeks) or once every two months (or every eight weeks) using the device. About 50 mg of fitusiran can be delivered in about 0.5 mL of PBS (at a concentration of about 100 mg fitusiran / mL).

[0201] In some embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 50 mg of nonacog alfa by subcutaneous dose approximately once every two months (or approximately every eight weeks). In other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 50 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 80 mg of nonacog alfa by subcutaneous dose approximately once every two months (or approximately every eight weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 80 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 20 mg of nonacog alfa by subcutaneous dose approximately once every two months (or approximately every eight weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 20 mg of nonacog alfa by subcutaneous dose approximately once a month (or every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 10 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 30 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 5 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 2.5 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks). In still other embodiments, the device can be used to prophylactically treat patients with hemophilia A or B (with or without inhibitors) with approximately 1.25 mg of nonacog alfa by subcutaneous dose approximately once a month (or approximately every four weeks).

[0202] Accordingly, a method for prophylactic treatment of a patient with hemophilia A or hemophilia B (with or without inhibitors) is provided herein, the method comprising delivering a preventive effective amount of fetucillin to a patient in need thereof subcutaneously with the device. The preventive effective amount of fetucillin can be any dosage provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The preventive effective amount of fetucillin can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The preventive effective amount of fetucillin can be delivered once about every month (or about every four weeks) or about every two months (or about every eight weeks). Fetucillin can be delivered by about 0.5 mL to about 1 mL delivery volume (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0203] As an example, a method of prophylactic treatment of a patient with hemophilia A or hemophilia B (with or without inhibitors) may include using the device to deliver about 50 mg of fetocillin subcutaneously to a patient in need thereof about once a month (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fetocillin may be delivered in about 0.5 mL of PBS (concentration of about 100 mg fetocillin / mL).

[0204] Further, a method is provided herein for reducing the frequency of bleeding episodes in patients with hemophilia A or B (with or without inhibitors), the method comprising delivering a preventive effective amount of fetosilan to patients in need subcutaneously with the device. The preventive effective amount of fetosilan can be any dosage provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The preventive effective amount of fetosilan can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The preventive effective amount of fetosilan can be delivered once about every month (or about every four weeks) or about every two months (or about every eight weeks). Fetosilan can be delivered by about 0.5 mL to about 1 mL delivery volume (for example, about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0205] As an example, a method of reducing the frequency of bleeding episodes in a patient with hemophilia A or B (with or without inhibitors) may include using the device to deliver about 50 mg of fetocillin subcutaneously to a patient in need thereof about once a month (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fetocillin may be delivered in about 0.5 mL of PBS (concentration of about 100 mg fetocillin / mL).

[0206] In addition, a method for reducing the ABR of a patient with hemophilia A or B (with or without inhibitors) is provided herein, the method comprising delivering a preventive effective amount of fetucillin to a patient in need thereof subcutaneously with the device. The preventive effective amount of fetucillin can be any dosage provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The preventive effective amount of fetucillin can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The preventive effective amount of fetucillin can be delivered once about every month (or about every four weeks) or about every two months (or about every eight weeks). Fetucillin can be delivered by about 0.5 mL to about 1 mL delivery volume (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0207] As an example, a method of reducing the ABR of a patient with hemophilia A or B (with or without inhibitors) may include using the device to deliver about 50 mg of fetocillin subcutaneously to a patient in need thereof about once a month (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fetocillin may be delivered in about 0.5 mL of PBS (concentration of about 100 mg fetocillin / mL).

[0208] In addition, a method for reducing the AjBR of a patient with hemophilia A or B (with or without inhibitors) is provided herein, the method comprising delivering a preventive effective amount of fetocillin to a patient in need thereof subcutaneously with the device. The preventive effective amount of fetocillin can be any dosage provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The preventive effective amount of fetocillin can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The preventive effective amount of fetocillin can be delivered once about every month (or about every four weeks) or about every two months (or about every eight weeks). Fetocillin can be delivered in a volume of about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0209] As an example, a method of reducing AjBR in a patient with hemophilia A or B (with or without inhibitors) may include using the device to deliver about 50 mg of fetocillin subcutaneously to a patient in need thereof about once a month (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fetocillin may be delivered in about 0.5 mL of PBS (concentration of about 100 mg fetocillin / mL).

[0210] In addition, a method for reducing the AsBR of a patient with hemophilia A or B (with or without inhibitors) is provided herein, the method comprising delivering a preventive effective amount of fetocillin to a patient in need thereof subcutaneously with the device. The preventive effective amount of fetocillin can be any dosage provided herein, such as about 1 mg to about 80 mg, about 1 mg to about 30 mg, or about 20 mg to about 80 mg. The preventive effective amount of fetocillin can be, for example, about 1.25 mg, about 2.5 mg, about 5 mg, about 25 mg, about 30 mg, about 50 mg, or about 80 mg. The preventive effective amount of fetocillin can be delivered about once a month (or about every four weeks) or about every two months (or about every eight weeks). Fetocillin can be delivered in a volume of about 0.5 mL to about 1 mL (e.g., about 0.5 mL, about 0.6 mL, about 0.7 mL, about 0.8 mL, about 0.9 mL, or about 1 mL).

[0211] As an example, a method of reducing AsBR in a patient with hemophilia A or B (with or without inhibitors) may include using the device to deliver about 50 mg of fetocillin subcutaneously to a patient in need thereof about once a month (or about every four weeks) or about every two months (or about every eight weeks). About 50 mg of fetocillin may be delivered in about 0.5 mL of PBS (concentration of about 100 mg fetocillin / mL).

[0212] 2. Examples of drug delivery devices without or with a separate syringe holder ( Figures 1A to 1D and Figure 2 )

[0213] Figure 2 An exploded view of an example of a drug delivery device 100 is shown without or with an optional separate syringe holder 800. The drug delivery device 100 may be an autoinjector adapted for automatic injection of a drug Dr. Triggering of the injection process may be done manually, ie by a user.

[0214] The drug delivery device 100 may include:

[0215] - Removable cap 200 and cap cover 300. After use of drug delivery device 100, reattachment of cap 200 and cap cover 300 may be prevented. Details of cap 200 and cap cover 300 will be explained in Section 3 below.

[0216] - A gripper 400 mounted on the cap 200 and configured to remove the RNS 914 or the soft needle shield SNS 914 of the prefilled syringe 900. The details of the gripper 400 will be explained in section 4 below.

[0217] - A needle shield 500 which is telescopically arranged within the device body 700. The details of the needle shield 500 will be explained in section 5 below.

[0218] - A needle shield spring 600 which biases the needle shield 500 in the distal direction D. The details of the needle shield spring 600 will be explained in Section 6 below.

[0219] - A device body 700 which is generally cylindrical and may include a distal opening configured to insert the needle shield 500 and a proximal opening configured to insert the drive spring retainer 1200 which may have a back housing function. The details of the device body 700 will be explained in Section 7 below.

[0220] - Optional syringe holder 800. The installation of a pre-filled syringe 900 without a syringe holder is described in more detail in Section 7 below. The details of the syringe holder 800 will be explained in Section 8 below.

[0221] - A pre-filled syringe 900. Details of the pre-filled syringe 900 will be explained below in Section 9. Alternatively, a cartridge or any other drug container configured to be connected to a removable needle may be used.

[0222] - Plunger 1000. The details of plunger 1000 will be explained in Section 10 below. Plunger 1000 can be used to expel the drug Dr out of the pre-filled syringe 900.

[0223] - Drive spring 1100. The details of the drive spring 1100 will be explained in Section 11 below. The drive spring 1100 can supply mechanical energy for automatic drug injection. Alternatively, other drive sources can be used, such as pneumatic energy or electrical energy.

[0224] - Drive spring retainer 1200. The details of the drive spring retainer 1200 will be explained in Section 12 below. The drive spring retainer 1200 can be a part of the housing, shell or device body 700, especially the rear part. The drive spring retainer 1200 can be configured to retain the drive spring 1100 and perform other functions, such as supporting the syringe flange 912 of the pre-filled syringe 900 via two support arms extending distally from the proximal plate of the drive spring retainer 1200.

[0225] - Clicker 1300. Details of the clicker 1300 are explained below in Section 13. The clicker may be an audible indicator and / or a tactile indicator or provide audible feedback and / or tactile feedback, for example indicating the end of dose delivery or other events.

[0226] The control subassembly (or front subassembly) may include a needle shield 500, a needle shield spring 600, and a device body 700. The control subassembly may control the prefilled syringe 900.

[0227] The plunger 1000, drive spring 1100, drive spring retainer 1200, and optional audible indicator or clicker 1300 may be included in a drive subassembly (or rear subassembly).

[0228] The drug delivery device 100 may include a shell designed as a multi-part shell. In particular, the shell may include a device body 700 forming a front shell and a rear shell, for example, formed by a drive spring retainer 1200. A portion of the drive spring retainer 1200 may be surrounded by the front shell or the device body in the longitudinal direction and is suitable for closing the open proximal end of the front shell. The proximal portion of the drive spring retainer may protrude from the proximal end of the device body. The shell may be suitable for retaining the pre-filled syringe 900 and other parts of the automatic injector 100.

[0229] The prefilled syringe 900 is arranged with a needle 908 at the distal end, for example, the needle post is connected to the neck of the syringe body. The prefilled syringe 900 can be preassembled. Typically, a protective needle shield can be removably connected to the needle 908 of the prefilled syringe 900. The protective needle shield can be a soft needle shield (e.g., a rubber needle shield SNS) 914 or a RNS 914 that can be composed of an inner rubber material and a full or partial plastic cover.

[0230] The plunger stopper 910 may be arranged for sealing the prefilled syringe 900 from the proximal side and for displacing the drug Dr or medicament M contained in the prefilled syringe 900 through the needle 908. In other exemplary embodiments, a cartridge or container may be used instead of the prefilled syringe 900, which includes the drug Dr or medicament M and is engaged with a removable needle (e.g., by threads, snaps, friction, Luer lock, etc.).

[0231] In an exemplary embodiment, the cap 200 can be removably disposed at the distal end DE of the device body 700 or the shell. The cap 200 can include a gripping element (e.g., including a barb, a hook, a narrowing section, etc.) of a gripper 400, which is arranged to engage with the protective needle shield RNS or SNS 914 of the prefilled syringe 900. The cap 200 can also engage with the needle shield 500 and / or with the device body 700. The cap 200 can include a gripping feature that facilitates the removal of the cap 200 (e.g., by twisting and / or pulling the cap 200 relative to the device body 700). In addition, the cap 200 can include a visual and / or tactile indication of the direction of removing the cap 200 from the device body 700, such as an arrow. The cap 200 can be, for example, a single part formed integrally by injection molding. Alternatively, the cap 200 can include several parts, such as a cap body 201 and a cap cover 300.

[0232] In an exemplary embodiment, the needle shield spring 600 may be arranged to bias the needle shield 500 in the distal direction D against the device body 700 .

[0233] In an exemplary embodiment, the drive spring 1100 may be disposed within the device body 700, for example mounted on a drive spring retainer 1200. The plunger 1000 may be used to transfer the force of the drive spring 1100 to a plunger stopper 910 within a prefilled syringe 900 or within another drug container.

[0234] In an exemplary embodiment, the plunger 1000 can be hollow and the drive spring 1100 can be disposed within the plunger 1000 such that the plunger 1000 is biased in the distal direction D relative to the device body 700 and / or the drive spring retainer 1200 .

[0235] In another exemplary embodiment, the plunger 1000 can be solid and the drive spring 1100 can engage the proximal end of the plunger 1000. Likewise, the drive spring 1100 can be wrapped around the outer diameter of the plunger 1000 and / or extend within the prefilled syringe 900.

[0236] In an exemplary embodiment, a plunger release mechanism may be arranged for preventing release of plunger 1000 before needle shield 500 is retracted relative to device body 700, and for releasing plunger 1000 once needle shield 500 is sufficiently retracted.

[0237] In an exemplary embodiment, a front needle shield locking mechanism may be arranged to prevent the needle shield 500 from being retracted relative to the device body 700 when the cap 200 is in place, thereby avoiding accidental activation of the autoinjector (i.e., drug delivery device 100) (e.g., if dropped during shipping or packaging, etc.).

[0238] Additionally, there may be a post-use needle shield locking mechanism that prevents the needle shield 500 from moving proximally after use of the drug delivery device 100 .

[0239] When the cap 200 is attached to the drug delivery device 100, the cap 200 can be restricted from axial movement in the proximal direction P relative to the device body 700 by the cap 200 abutting the device body 700. When the cap 200 is pulled in the distal direction D relative to the device body 700, the gripper 400 of the cap 200 can grasp the RNS or SNS 914 and can also allow the RNS or SNS 914 to be removed.

[0240] In the illustrated embodiment, the cap 200 may include a closable opening for inserting a front assembly tool. The cap 200 may be permanently closed at its distal end.

[0241] The drug delivery device 100 may include at least one clicker 1300 for generating auditory feedback and / or tactile feedback when the delivery of the drug Dr or the medicine M is completed. In the context of the present invention, the clicker 1300 may also be referred to as an auditory indicator and / or a tactile indicator. The auditory indicator and / or the tactile indicator 1300 may be formed as, for example, a monostable or bistable spring, such as a leaf spring, and may be retained in the drive spring retainer 1200 or the rear housing.

[0242] The drive spring holder 1200 or the rear shell can be suitable for preventing the pre-filled syringe 900 from moving axially after assembly (particularly during storage, transportation and normal use). In detail, the drive spring holder 1200 can include an elastic arm, such as two elastic arms, at its front end. The elastic arm can be formed as a labyrinth arm to attenuate the impact force. The elastic arm can be installed on the more rigid arm (such as two rigid arms) of the drive spring holder 1200. The rigid arm can extend to the distal direction from the proximal plate of the drive spring holder 1200. The two rigid arms can be arranged parallel to each other or substantially parallel to each other. The drive spring holder 1200 can include a center pin for guiding the drive spring 1100. The center pin and the proximal plate can be an integral part of the drive spring holder 1200, or can be its separate part, such as being integrated into a single part independent of the drive spring holder 1200.

[0243] In an exemplary embodiment, the drug delivery device 100 can be formed from at least two subassemblies, such as a control subassembly or front subassembly and a drive subassembly or rear subassembly, to allow flexibility in the time and location of manufacture of the subassemblies and the time and location of final assembly with the prefilled syringe 900.

[0244] 3. Caps and caps ( FIG. 3A to FIG. 3I )

[0245] Figure 3A An optional cap 200 is shown with an optional cap cover 300 mounted thereon, wherein the cap 200 and cap cover 300 are separate from the device body 700 and the needle shield 500. The cap 200 may be a different color than the device body 700. FIG. 3A to FIG. 3I The cap 200 shown in FIG. Figure 4F , Figure 4H and Figure 6BThe cap 200 shown in or the same as it. The material selected for the cap 200 and / or the cap cover 300 can be Bayblend M850XF, a medical grade PC / ABS blend. PC / ABS can be selected, mainly considering its strength, flexibility and its strength at high temperature, so as to allow the injection molding cycle time to be shortened, so as to allow the cost of parts to be reduced. The cap 200 includes a cap body 201. The cap body 201 (for example, when viewed in a plan view) has the shape of a truncated cone, wherein the radial and / or circumferential dimensions of the cap body 201 increase along the longitudinal axis A along the distal direction D. This shape supports the user to grasp the cap 200 and pull off the cap along the distal direction D, for example, by moving the pure axial direction relative to the device body. Observed from above, i.e., observed along the longitudinal axis A, the cap body 201 can have an oval shape or a rectangular shape with rounded corners. This shape can also support the user to grasp the cap 200 and pull off the cap along the distal direction D. In addition, this shape can prevent the drug delivery device 100 from rolling away when being put down by the user. To further facilitate manipulation by the user, particularly when removing the cap 200, the cap 200 features a gripping surface 202, such as a side surface of the cap 200. The gripping surface 202 may have a ribbed, flared, square geometry. Figure 3A As shown in , the cap 200 has at least one user indicator 203 on the cap on its surface. Preferably, the cap 200 has two user indicators 203 on the cap, which are arranged relative to each other. In the depicted embodiment, the user indicator 203 on the cap has the shape of an arrow pointing to the distal direction D. Before the arrow starts in the proximal direction, the cap 200 can have a rectangular recess. The user indicator 203 on the cap and the user indicator 733 on the body (as described in Section 7 below) can form a user indicator. Therefore, the user indicator 203 on the cap shows the user in which direction the cap must be pulled when the cap 200 is removed from the drug delivery device 100. Since the arrow is designed as a recess in the cap surface, the arrow also supports the user's firm grip when the cap 200 is gripped and pulled. Therefore, the user indicator 203 on the cap provides both visual and tactile assistance to the user. Furthermore, the cap 200 includes at least one cap clip 204 to connect or mount the cap 200 to the needle shield 500 and thus to the device body 700. Figure 3B , Figure 3C , Figure 3F , Figure 3H and Fig. 3I As depicted, the cap clips 204 may be designed as elastic members having free ends in the proximal direction that engage with corresponding portions of the needle shield 500. The corresponding portion of the needle shield 500 may be a cap clip window 504 as described below. The cap 200 preferably has two opposing cap clips 204. Figure 3B , Figure 3C , Figure 3F , Figure 3H and Fig. 3I As depicted, the cap clip 204 is an integral part of the cap 200. The cap clip 204 has a proximal free end in the proximal direction that defines the clip 204. The free end has a hook or retaining element pointing inwardly in the radial direction. The retaining element is designed to engage in the cap clip window 504 of the needle shield 500. The cap 200 has two diametrically opposed cap recesses 213. In the depicted embodiment, the recesses 213 are on the same side as the arrow (see Fig. 3I ). Preferably, the recess 213 has a trapezoidal shape (when viewed in a plan view). The width of the respective recess increases in the proximal direction.

[0246] In addition, the cap 200 includes at least one, preferably more than one, for example four anti-rotation ribs 205. The anti-rotation ribs 205 can assist in enabling the cap 200 to be assembled to the device body 700 in only one orientation, so that the user indicator 733 on the body and the user indicator 203 on the cap are rotationally aligned, and the combined indicators are axially oriented. When the cap 200 is attached to the drug delivery device 100, the anti-rotation ribs 205 prevent the cap 200 from accidentally rotating relative to the housing body 700, which may cause damage or perforation of the needle shield because the needle shield is properly rotationally locked with the cap. For example, in Figure 3A , Figure 3H and Fig. 3I As can be seen in the figure, the anti-rotation rib 205 can be an elongated rod extending in the proximal direction along the longitudinal axis of the cap 200 or the device. The anti-rotation rib 205 can be an integral protrusion of the cap 200. Each anti-rotation rib 205 can be chamfered at its proximal end so that the anti-rotation rib 205 has a slope at its proximal end.

[0247] The anti-rotation ribs 205 may be designed as elongated (e.g., with their major extension along the longitudinal axis A) locking lugs that slide into corresponding recesses or cap grooves 725 in the device body 700 when the cap 200 is attached to the device body 700. Thus, it is not possible to rotate the cap 200 relative to the device body 700 (i.e., the drug delivery device 100). The on-cap user indicator 203 may be on the same plane as the anti-rotation ribs 205 and the cap recess 213.

[0248] like Figure 3B and Figure 3C As shown in FIG. 1 , the cap clip 204 can help implement drop protection, i.e., a drop protection mechanism. In the depicted embodiment, the device 100 includes two cap clips 204. The drop protection mechanism properly prevents the drug delivery device 100 from being fired if it is dropped. Without such a mechanism in place, if the drug delivery device 100 cap 200 falls upward, when the drug delivery device 100 is from the first cover position X (see FIG. 1 ), the cap clip 204 can be used to prevent the drug delivery device 100 from being fired. Figure 1B ) hits the ground to the second cover position Y (see Figure 1C ), the needle shield 500 may continue to move under its own inertia, thereby allowing the device 100 to fire. The cap clip 204 prevents this. Figure 3B 1 shows the drug delivery device 100 in its pre-use state, wherein the needle shield 500 is in the first shield position X biased forward by the needle shield spring 600. The cap clip 204 is located in the corresponding cap clip window 504 of the needle shield 500, and as shown in FIG. Figure 3C As depicted, the needle shield 500 is restricted from moving backward in the proximal direction P. Therefore, if the cap clip 204 is located in the corresponding cap clip window 504, the needle shield 500 cannot reach the second shield position Y. The cap clip 204 is blocked by the cap rib 727 (see FIG. 204 ) on the device body 700. Figure 7F ) to prevent the cap clip from deflecting outward. When the user removes the cap 200, the cap 200 first moves forward, allowing the cap clip 204 to move into the wider section of the device body 700 before the cap clip 204 contacts the needle shield 500, so that the cap clip 204 can deflect outward and the cap 200 can be removed.

[0249] Figure 3D and Figure 4F The interior of the cap 200 is shown. The cap 200 has a cap opening 206 for receiving the grabber 400. The cap opening 206 extends distally to the cap shell or cap tube 210. The cap tube 210 can have a cylindrical shape. The cap opening 206 can be defined by the cap tube 6. The cap opening 206 can be at the proximal section of the cap tube 210. A plurality of grabber retaining bosses 207 (e.g., two grabber retaining bosses 207) are arranged, for example, equidistantly along the circumferential inner surface of the cap tube to prevent the grabber 400 from moving relative to the cap 200 in the proximal direction P. The retaining bosses are positioned distal to the cap (tube) opening 206. Regarding the interaction between the cap opening 206 and the grabber 400, refer to 4A to 4H Description of Figure 3D As can be seen in the cap, the cap has several apertures in the longitudinal direction, namely distal apertures 208 or device activation apertures. These apertures 208 can be used as a passage for tools to activate the device. Activation can involve bringing the device into a state where the device can be triggered. Activation can involve movement of the needle shield and is a step performed during assembly, for example near the end of assembly of the device (this will be described further below).

[0250] Further, the cap 200 includes at least one, but preferably two cap clips 209 to attach the cap 300 to the cap 200. Preferably, the two cap clips 209 are arranged opposite to each other. The cap 200 may have a surface 214 that is interference-fitted with the cap 300. For example, in Figure 2 , Figure 3A , Figure 3B , Figure 3C , Figure 3E and Figure 3FAs can be seen in FIG, the cap 300 can be arranged in the distal region of the cap 200 . Figure 3E A lateral cross-sectional view of the cap 300 is shown. The cap 300 has a cap outer surface 301 which closes the cap 200 in the distal region. Thus, the distal hole 208 of the cap 200 can be sealed (made inaccessible). Another function of the cap 300 is to prevent the user from reapplying the cap to a drug delivery device 100 that has already been used, wherein this is implemented with the aid of an anti-recap mechanism. The cap 300 further comprises an inner surface facing in the proximal direction P. The inner surface has at least one cap spacer 302. Preferably, as Figure 3E and Figure 3F As depicted, the cap 300 comprises two cap spacers 302. The cap spacers 302 are arranged opposite to each other. Furthermore, the distance between the two end regions of the cap spacers 302 pointing in the proximal direction P at least substantially corresponds to and / or is adjusted to the skin contact surface 501 of the needle shield 500 (see Figure 5 ). In other words, the distance between the cap spacers may be between the inner diameter of the ring defining the annular skin contacting surface and the outer diameter of the ring. Figure 3F Once the drug delivery device 100 has been removed from the injection site and the needle shield 500 has been brought to its final locked position (see Figure 1D ), the anti-recapping mechanism prevents the cap 200 from being replaced on the used drug delivery device 100. Since the needle shield 500 is Figure 1D ) than before the allocation (see Figure 1B ) protrudes further distally from the device body 700, and due to the appropriate selection of the distance between the cap spacers 302, attempts to reattach the cap 200 to the device body 700 (such as Figure 3F ) will result in direct contact between the needle shield 500 and the cap 300 before the cap is connected to the rest of the device. This means that the cap 300 (i.e., the cap spacer 302) contacts the needle shield 500 (i.e., the skin contact surface 501) before the cap 200 can be fully seated on the device body 700. Since the anti-recap mechanism prevents the cap 200 from being placed on the drug delivery device 100 in the same manner as it was initially placed with the needle shield and the cap cooperating, the appearance of the drug delivery device 100 attempting to reposition the cap 200 also becomes different, making the used drug delivery device 100 with the cap 200 visually and tactilely distinguishable from the unused drug delivery device 100 with the cap 200. Advantageously, the cap cannot be placed on the device body at all, at least not in the position that the cap originally had (i.e., before the cap was separated from the rest of the device to use the device).

[0251] like Figure 3G As depicted, the cap 300 preferably has two oppositely arranged positioning structures or positioning arcs 303. Preferably, each positioning arc 303 has a positioning guide 303a in the end region, which is designed as an integral protrusion of the positioning arc 303. Therefore, the cap 300 has four positioning guides 303a. The cap 300 preferably has an interference fit rib 303b in the middle of the corresponding positioning arc 303a. Preferably, each positioning arc 303 has three ribs 303b. The rib 303b is configured to form an interference fit with the corresponding interference fit surface 214 of the cap 200. In addition, the cap 300 preferably has two oppositely arranged recesses 304.

[0252] 4. Grabber ( 4A to 4H )

[0253] 4A to 4H An optional grabber 400 is shown. The cap 200 may be adapted to form part of a needle shield remover or removal assembly. To this end, the cap 200 and the grabber 400 may be connected in such a way that the needle shield 914 is removed from the needle 908 when the cap 200 is removed together with the grabber 400 from the drug delivery device 100. In other words: the grabber 400 is coupled to the cap 200 in such a way that when the cap 200 is removed, the needle shield 914 is also removed from the needle 908. The grabber may be axially locked to the cap.

[0254] Figure 4A and Figure 4B A perspective view of an optional grabber 400 and a cross-section of the grabber 400 are shown, respectively. The grabber 400 may be a sheet metal component that is located inside the cap 200 and removes the needle shield 914 from the prefilled syringe 900 during cap removal. The needle shield 914 (e.g., Fig. 9 ) can be a rigid needle shield (RNS) or a soft needle shield (SNS).

[0255] In this example, the gripper 400 may be formed from a single piece, such as a sheet of material, such as a sheet of metal or a sheet of a metal alloy (see, e.g., Figure 4C ). The gripper 400 may include at least a body or gripper bracket 402. The gripper bracket 402 may be bent or kinked multiple times along multiple longitudinal fold edges, kinks or bends 404 to form multiple bracket portions 406. The respective bracket portions 406 may have or include a planar outer surface area or a substantially planar outer surface area.

[0256] Furthermore, the planar outer surface area of ​​the gripper support 402 can be bent or angled in such a way that the outer support parts 406 partially overlap in the overlapping area 408. Thus, in the bent state, the gripper support 402 can have, for example, a pipe form or tubular type with a polygonal cross section. Other cross sections are also possible, for example a circular cross section. The partially overlapping area 408 in the bent state of the gripper support 402 can allow compensation for manufacturing tolerances of the gripper 400. The gripper support 402 can have longitudinal free ends, which can be arranged close to the overlapping area 408.

[0257] To grasp the needle shield 914, more than one of the plurality of bracket portions 406 may include a cutout or opening 410 from which a corresponding barb 412 may be bent and may protrude inwardly from an inner surface of the grabber bracket 402 and, therefore, from an inner surface of the bracket portion 406. In the assembled state, the inwardly angled barbs 412 may extend in a distal direction D of the grabber 400 and, therefore, the drug delivery device 100.

[0258] The barbs 412 may be adapted to deflect and grasp the needle shield 914 during assembly of the needle shield 914 into the drug delivery device 100 (see, e.g., Figure 4D , Figure 4E and Figure 4H ), and may be adapted to further grip the needle shield 914 as the cap 200 is being removed from the drug delivery device 100.

[0259] The barb 412 may be designed as a hook or may have a prong form. In particular, the barb 412 may protrude inwardly from the inner surface of the support portion 406 and may include a prong 414 on its free end. The prong 414 may be adapted to abut or penetrate into the outer surface of the needle shield 914. The prongs may be designed to form an interference fit and / or a form fit and / or a press fit during assembly, or at least to form a forced connection and / or a non-forced connection during removal of the needle shield 914 from the needle (see, for example, Figure 4D and Figure 4E According to another aspect, the tines 414 may be adapted to already penetrate into the outer surface of the needle shield 914 when the grabber 400 is being assembled to the needle shield 914. That is, a form fit or a positive fit may be applied already during the assembly process, and not just after the cap removal process has begun.

[0260] According to the present embodiment, the tines 414 may be configured as double spikes, respectively, disposed on each barb 412. This configuration may be achieved by a concave shape between the two tines 414 of each barb 412. Due to the concave shape and thus controlling the distance between the tines 414, the penetration depth into the surface of the needle shield 914 may be limited. This may be particularly important when the needle shield 914 is a rubber needle shield, where penetration beyond a certain limit may affect sterility by touching the needle 908.

[0261] An opening 410 with corresponding barbs 412 may be disposed on a distal portion D6 (eg, distal half) of the grabber cage 402, while a proximal portion D5 (eg, proximal half) of the grabber cage 402 may include a grabber portion 406 without any openings or barbs.

[0262] Viewed in the longitudinal direction, the proximal portion D5 and the distal portion D6 may have substantially the same length. However, the proximal portion D5 may also be longer than the distal portion D6. The proximal portion D5 may be, for example, about 10 mm, and the distal portion may be 9 mm.

[0263] The sum of the lengths of the proximal portion D5 and the distal portion D6 corresponds to the overall length of the gripper 400 as viewed in the longitudinal direction.

[0264] The overall length of the gripper may for example be between 15 mm and 25 mm, for example 19 mm.

[0265] The grabber 400 may have two opposing axial ends, namely a first end or leading end 418 located on a distal portion D6 of the grabber support 402 and a second end or trailing end 420 located on a proximal portion D5 of the grabber support 402 .

[0266] The first end 418 (e.g., the leading end 418) of the grabber 400 may be the end that is first introduced into the cap opening 206 of the cap 200 during assembly. The grabber 400 may have an inclined surface region 422 disposed at the leading end 418. As viewed from the first end 418, the region 422 may be inclined and away from the axis.

[0267] The regions 422 may be designed to interact with the gripper retention bosses 207 which should engage associated gripper interface features 410b, such as openings 410b and / or retention slots 410b (see Figure 4F and Figure 4E). When assembled to the cap 200, the deflected surface area 422 can be angularly aligned with the grabber interface feature 410b and / or the grabber retention boss 207 that should engage with the grabber interface feature. In the axial direction, the deflected surface area 422 is offset distally relative to the grabber interface feature 410b. Figure 4A In the depicted embodiment, the gripper interface feature is formed by the opening 410. When the gripper retaining boss 207 contacts the surface area 422 during the insertion of the gripper 400 into the cap opening 206 and the gripper 400 is further guided into the cap opening 206, the elastic deformation of the gripper 400 in the radial direction can increase, for example, until the gripper interface feature (opening 410b / retaining groove 410b) engages with the gripper retaining boss 207 (see, for example, Figure 4F ). When engagement is established, the resilient bias of the catcher 400 may be reduced, for example until the catcher 400 abuts the cap 200.

[0268] exist Figure 4A , a cutout is shown forming a grabber orientation feature 416. The cutout can have oblique side surfaces 424 that define the cutout at an angle. Axially, as viewed in an axial direction away from the first end 418 (e.g., in the proximal direction P), the cutout can be defined by a surface 426. The angular extension of the cutout can decrease or reduce as the distance from the first end 418 increases. In other words, the cutout can taper toward the second end 420 (e.g., toward the proximal direction P). When the cutout is viewed in a plan view or a top view, the surface 426 that defines the cutout in the axial direction can extend perpendicular to the axis A. When the cutout is viewed in a plan view or a top view, the angle of the surface 424 relative to the axis can be less than 90°, such as 45 degrees or less.

[0269] The kink, fold or bend region 404 may extend along the longitudinal direction of the gripper 400, preferably along the entire axial extension of the gripper 400. Accordingly, at the leading end or leading edge 418, the kink, fold or bend 404 may define a corner 428. The respective corner may be an angled region of the edge of the gripper 400. The edge or corner 428 may be oriented in the axial direction, i.e., away from the cap opening 206.

[0270] The trailing end 420 of the gripper bracket 402 may include at least one additional cutout 434. The cutout 434 has the function of helping the assembly head maintain orientation during assembly, such as assembly of the gripper 400 with a cap.

[0271] The trailing end 420 may also include smaller depressions 436 that are formed during production of the metal sheet that is later used to form the gripper 400. …

[0272] Figure 4CAn exemplary embodiment of a single piece of sheet material 430 that can form a grabber support 402 is shown. The metal sheet, and therefore the grabber 400, can include two groups of three openings 410a, 410b, 410c. Each opening 410 can include a corresponding barb 412. The web between the openings 410a, 410b, 410c can be optional, for example, there can be a common opening for several barbs 412. All barbs 412 can have the same length and / or shape. Alternatively, the shape and / or length of at least one of the barbs 412 can be different from the shape and / or length of the other barbs 412.

[0273] The two sets of openings, such as 410a, 410b, 410c, are arranged on the metal sheet in such a manner that the two sets of openings 410 and their corresponding barbs 412 can be positioned substantially opposite to each other when the grabber support 402 is formed. In this way, during the removal of the needle shield (RNS or SNS) 914, the force applied by the barbs 412 on the needle shield is more evenly and / or symmetrically distributed, and the needle shield can be better removed.

[0274] According to one aspect of the present disclosure, the gripper 400 can be produced by the following steps:

[0275] - providing a gripper support 402 in the form of a sheet 430, for example a metal sheet, such as a stamped or punched (punched) metal sheet;

[0276] - forming a plurality of barbs 412 on the grabber support 402 by cutting, stamping, embossing or molding;

[0277] - a plurality of bends or kinks are performed on the grabber bracket 402 along a plurality of longitudinal fold edges or lines 404 to form a plurality of bracket portions 406 in such a manner that more than one of the plurality of bracket portions 406 may include a respective barb 412;

[0278] - bending the barbs 412 in such a way that they protrude from the inner surface of the associated bracket portion 406, e.g. Figure 4A and Figure 4B as shown in .

[0279] The sheet 402 may be a single piece of sheet metal that may be cut, such as by punching or coining, to form the cutouts or openings 410 and the barbs 412 in the cutouts or openings 410 .

[0280] The sheet material may comprise stainless steel, such as EN 1.4310, a high strength stainless steel.

[0281] The maximum outer diameter of the gripper 400 in the assembled state may depend on the transverse length l1 of the sheet. However, when the two longitudinal edges of the folded sheet 430 abut, the maximum outer diameter of the gripper 400 in the assembled state may be smaller than the outer diameter of the sheet. This may be because the gripper 400 has an overlap area 408 in its assembled state (see, e.g. Figure 4A and Figure 4B ).

[0282] The openings 410 may have a generally rectangular form. The extent of the openings 410 along the transverse axis of the sheet 420 may represent the width or breadth of the openings 410 (eg, 410a, 410b, and 410c).

[0283] The barbs 412 may have a smaller width than the openings 410 and may extend longitudinally along at least one third of the respective openings 410 .

[0284] In particular, the length of the barb 412 along the longitudinal axis can be greater than or equal to 0.5 mm, 1 mm, or 2 mm, which is measured from the proximal end of the barb 412 to the distal end of its prongs.

[0285] In particular, the length of the barb 412 along the longitudinal axis can be less than or equal to 3 mm, 2 mm or 1 mm. In particular, the width of the barb can be 1 mm, 2 mm or 3 mm.

[0286] Figure 4D and Figure 4E The grabber 400 is shown in an engaged position with the needle shield 914 of the syringe 900. All other elements, such as the body or barrel 902 of the syringe 900, and the cap 200, are not depicted in this figure.

[0287] As can be seen, the grabber 400 can be arranged on the distal portion of the needle shield 914 so that at least the proximal portion D4 of the needle shield between the proximal end of the grabber 400 (e.g., the trailing edge 420) and the proximal end of the needle shield 914 is not covered.

[0288] Accordingly, the length of the grabber 400 may be shorter than the length of the needle shield it is intended to grasp, such that the proximal portion of the needle shield 914 extends proximally beyond the proximal portion of the grabber 400 .

[0289] The leading edge 418 of the grabber 400 may be aligned with the distal end of the needle shield 914 along a vertical plane, or it may be substantially aligned with the distal end of the needle shield 914 .

[0290] In the assembled position of the catcher 400 and the needle shield 914, the barb 412 is properly bent and penetrates the needle shield 914. Figure 4DAs can be seen in the figure, the contact point (e.g., penetration point) of the barb 412 with the needle shield 914 can be offset distally relative to the longitudinal midpoint of the needle shield 914. In other words, the grabber 400 can grab the needle shield 914 at the distal portion of the needle shield 914. In other words, the grabber 400 can interact with the needle shield 914 via the barb 412 at a distance from the proximal end of the needle shield 914 that is approximately the sum of the portion D4 and the portion D5 (and the length of the barb 412).

[0291] The proximal portion D5 of the grabber 400 may be advantageous in that the needle shield 914 is kept stable during removal of the cap 200 and thus the needle 908 itself. In this way, the sterility of the needle 110, 908 may be further maintained.

[0292] The required size of the gripper 400 depends on the drug delivery device, the prefilled syringe, and in particular on the needle shield used in the particular drug delivery device, and may vary accordingly.

[0293] Figure 4F A cross-sectional view of the grabber 400 of the previous embodiment assembled within the cap 200 is shown.

[0294] As can be seen, the gripper 400 is inserted into the cap opening 206 ( Figure 3D ), the cap opening is configured and / or sized to receive the grabber 400 when introduced. The cap opening 206 can be defined by a tubular or sleeve-like portion of the cap 200, which can be sized to receive the grabber 400 therein.

[0295] In addition, in order to orient the gripper 400 correctly during assembly in the cap 200, the gripper 400 may include an orientation element 416 that indicates the assembly orientation. The orientation element 416 may be designed as a tactile indicator or a visual indicator or a combination thereof. In particular, a front surface of the gripper bracket 402 is profiled, such as wavy or forked. The orientation feature 416 may be a cutout as described in more detail above.

[0296] The cap 200 may further include at least two lugs, bosses or grabber retention bosses 207 which may be designed to engage with one of the three openings 410, preferably the middle opening 410b. In the assembled state, the grabber retention bosses 207 may abut the respective distal ends 432 of the openings 410 and retain the grabber 400 in its position within the cap 200, see Figure 4G .

[0297] In the context of the present disclosure, “angular” may refer to an azimuthal direction, ie, a direction defined by an azimuth or rotational angle relative to an axis, such as relative to a longitudinal axis extending through the cap opening 206 .

[0298] The grabber 400 may be elastically deformed during the assembly process. Here, before the grabber 400 engages with the grabber retaining boss 207, the grabber 400 is first slightly elastically deformed, for example, due to the fact that the diameter of the cap opening 206 is smaller than the diameter of the undeformed grabber 400. Then, the radial elastic deformation increases. Accordingly, there may be a force acting in the radial direction, and this force may tend to expand the diameter of the grabber 400 in one or more regions that are angularly offset relative to the grabber retaining boss 207.

[0299] Especially Figure 3D As depicted, cap 200 may include at least one, and preferably four, grabber guide features 211 and inner distal apertures 212 .

[0300] In embodiments suitable for reducing or preventing scratching or debris generation, the sensitive area of ​​the cap 200 may include an inner distal aperture 212 .

[0301] The inner distal hole 212 can extend radially through a segment of the cap, such as the cap shell 210. The inner distal hole 212 can be defined during molding of the cap 200.

[0302] The inner distal aperture 212 may axially overlap the grabber retention boss 207 .

[0303] The inner distal hole 212 may extend axially in a region that is offset distally or away from the cap opening 206 relative to the grabber holding boss 207 , preferably in the entire region up to the end of the receiving space of the cap shell 210 .

[0304] The opening may axially overlap the grabber retaining boss 207. The use of the inner distal hole 212 has also proven to be particularly advantageous in avoiding scratches or debris.

[0305] It should be noted that since the inner distal hole 212 is provided in the sensitive area, there is no grabber guide feature 211 in this area.

[0306] As depicted, none of the grabber guide features 211 may be angularly offset relative to the inner distal aperture 212 or sensitive area.

[0307] Thus, despite the presence of the inner distal hole 212 in the sensitive area, a grabber guide feature 211 can be established that guides the engagement of the interface features of the gripper and cap during assembly.

[0308] exist Figure 4G, the interaction between the gripper retaining boss 207 of the cap 200 and the opening 410b / retaining slot 410 of the exemplary gripper 400 is shown in more detail.

[0309] The gripper retaining boss 207 includes an inclined region or ramp section 207a at its proximal end. The preferably planar surface of the section or region may form or define an acute angle with the longitudinal axis A, for example, less than 45°. At its distal end, the gripper retaining boss 207 may be arranged to interact with a surface 432 of the gripper 400 (e.g., a surface 432 that distally defines the retaining groove 410b and / or the opening 410b). The distally disposed end surface 207b of the gripper retaining boss 207 preferably defines or forms an angle with the axis A that is greater than the angle defined by the proximal ramp section 207a with the axis A. For example, the end surface 207b may be oriented perpendicularly relative to the axis A. The proximal ramp section 207a and the end surface 207b may be connected by a connecting region 207c, which may extend substantially parallel to the axis A.

[0310] In the assembled position, the end surface 207b of the grabber retaining boss 207 may distally abut the surface 432 of the retaining slot 410b and / or the opening 410b.

[0311] Figure 4H A cross section of the front end of the injection device 100 is shown, with the cap 200 mounted thereon and the grabber 400 mounted thereon and interacting with the needle shield 914 .

[0312] As shown, the barbs penetrate the needle shield 914 so as to capture the needle shield and enable the needle shield 914 to be removed by removing the cap 200. The length of the barbs 412 may be such that only the tip of the barb penetrates the needle shield 914 so as to maintain the sterility of the needle 908.

[0313] In this illustration, the grabber guide feature 422 does not contact the needle shield 914 because the diameter of the needle shield at its front end (e.g., its distal end) is smaller than its diameter at its proximal end. In embodiments where the needle shield 914 has a constant diameter from the proximal end to the distal end, the leading edge 422 will contact the outer surface of the needle shield 914 and provide a guiding aid during assembly of the grabber 400 onto an injection device 100 where the injection needle includes a needle shield of constant diameter.

[0314] 5. Needle cover (needle cannula) Figure 5 )

[0315] like Figures 1B to 1D As depicted, the drug delivery device 100 may further include a needle shield 500. The needle shield 500 may include a needle shield 500. Figure 5The needle shield 500 may protrude distally from the device body 700 and / or may be covered by the cap 200 when the cap 200 is attached to the device body 700. The needle shield 500 may be moved relative to the device body 700 from a first shield position X (see Figure 1B ) moves to the second cover position Y (see Figure 1C ).

[0316] The needle shield 500 can be configured to extend beyond the distal end of the needle 908, which can protrude from the device body 700 before the drug delivery operation begins. The needle shield 500 can move in a proximal direction P relative to the device body 700. During this movement, for example, before the needle shield 500 reaches the second shield position Y, the needle 908 can pierce the user's skin. The needle shield 500 can be used as a trigger member of the drug delivery device 100. The needle shield 500 as a trigger member can automatically initialize the drug delivery operation when it is proximally displaced from the first shield position X to the second shield position Y, preferably when it is in the second shield position Y. The needle shield 500 can be maintained in contact with the skin until the drug delivery operation has been completed, which can be indicated by an audible, tactile and / or visual indication provided by the drug delivery device 100. After the drug delivery operation is completed, the needle shield 500 can be moved distally relative to the device body 700 to a third shield position Z (see Figure 1D ) to cover the end of needle 908.

[0317] The drug delivery operation of the drug delivery device 100 can be initialized by removing the mechanical lock that prevents the plunger 1000 from moving in the distal direction or by disengaging the mechanical lock by moving the plunger 1000. Alternatively, the needle shield 500 can only trigger the drug delivery operation when it moves from the first shield position X to the second shield position Y and when it is in the second shield position Y. In this case, a separate trigger member (e.g., a trigger button on the proximal end of the device body 700) can be provided to start the drug delivery operation. Only when the needle shield 500 is in the second shield position Y can the trigger button be operated to start the drug delivery operation. In another alternative, the needle shield 500 can only be arranged to prevent needle sticks before and / or after using the drug delivery device. In this case, the needle shield 500 can be completely decoupled from the drive mechanism 101 and / or not participate in the triggering of the drug delivery operation or realize the triggering of the drug delivery operation. In the device currently described, the needle shield acts as a trigger member. Therefore, the user does not need to actuate a separate trigger member.

[0318] As described in more detail below, the drug delivery device 100 may include a needle shield spring 600. The needle shield spring 600 may be operatively coupled to the needle shield 500 so as to move the needle shield 500 in a distal direction D relative to the device body 700 when the drug delivery device 100 is removed from the skin. In order to move the needle shield 500 in a proximal direction P away from the first shield position X, the force of the needle shield spring 600 must be overcome. After the drug delivery operation has been completed, the needle shield 500 is in a final or third shield position Z (see FIG. Figure 1D ), the drug delivery device 100 has been removed from the skin and the needle shield spring 600 has displaced the needle shield 500 distally, at which time the needle shield 500 can be locked to resist proximal movement relative to the device body 700.

[0319] Figure 5 A detailed exemplary illustration of a needle shield 500 is shown. The needle shield 500 may include a skin contact surface 501 of circular shape or other shape, which is arranged at a cylindrical distal end portion 502 of the needle shield 500 and is designed to be placed on the skin of a user. The skin contact surface 501 may have an opening concentric with the circular shape, which extends axially through the cylindrical distal end portion in the proximal direction, wherein, in the assembled state of the drug delivery device 100 (when viewed in a plan view), the opening surrounds the needle 908. Starting from, for example, the cylindrical distal end portion 502, the needle shield 500 may have a side region 503 extending in the proximal direction P. In the example shown, the needle shield 500 may have two side regions 503, but it should be noted that the needle shield 500 may have more than two, such as three or four side regions 503, and each side region 503 may have all the features of the side region 503 described below. The two side regions 503 are arranged opposite each other and are designed to enclose the optional syringe holder 800 (if present), the prefilled syringe 900, the plunger 1000 and / or the drive spring 1100 when the drug delivery device 100 is assembled. The side regions may be legs.

[0320] Each of the two side regions 503 includes a side region inner surface 503a and a side region outer surface 503b, wherein the side region inner surface 503a faces the longitudinal axis in the radial direction and the side region outer surface 503b faces away from the longitudinal axis in the radial direction. The side region 503 includes two lateral edges 503.1, and the side region 503 includes three recesses, namely, the cap clip window 504, the front stop groove 505 and the plunger boss groove 506. In the depicted embodiment, the front stop groove 505 can be located between the cap clip window 504 and the plunger boss groove 506 in the axial direction, wherein the cap clip window 504 can be offset in the distal direction relative to the front stop groove 505, and the plunger boss groove 506 is offset in the proximal direction relative to the front stop groove 505.

[0321] The cap clip window 504 may be a (e.g., rectangular) recess into which the cap clip 204 may engage when the cap 200 is mounted to the device body 700. The connection between the cap clip 204 and the cap clip window 504 may prevent axial movement of the needle shield 500 relative to the device body 700. Such a connection may provide a safety feature that may prevent accidental activation of the dispensing mechanism, for example, if the drug delivery device 100 is accidentally dropped by a user.

[0322] The front stop groove 505 can be a (eg, rectangular) rectangular recess that can be aligned with the needle shield front stopper 724 (eg, Figure 7C Bosses 724 shown on the inner surface of the device body 700 interact with each other to define a maximum distal position of the needle shield relative to the device body 700 after operation of the drug delivery device (eg, at the end of an injection).

[0323] The plunger boss groove 506 may be an L-shaped recess, i.e., a recess formed by two rectangles of different sizes, i.e., a proximal groove 506a and a distal groove 506b placed directly adjacent to each other. The angular width of the proximal groove 506a may be smaller than the angular width of the distal groove 506b. The plunger boss groove 506 and at least one plunger boss 1040.2, 1040.3 of the plunger 1000 (see Fig.10 ) can form a mechanical lock, such as a rotation lock. As long as the mechanical lock is established, the needle cover 500 can be maintained in the first cover position X. The plunger boss groove 506 can be configured to allow the needle cover 500 to move relative to the plunger 1000 when the needle cover 500 moves from the first cover position X to the second cover position Y so as to release the mechanical lock. Here, due to the plunger boss 1040.2 (see Fig.10 ), which prevents the plunger 1000 from rotating relative to the needle shield 500 until the plunger bosses 1040.2, 1040.3 (see Fig.10 ) moves in the axial direction from the proximal groove 506a to the distal groove 506b.

[0324] The plunger boss groove 506 may include a groove rib 507 located on one side of the transition from the proximal groove 506a to the distal groove 506b, and the groove rib may include a shoulder 507a due to the different sizes of the rectangle. The groove rib 507 may include an abutment surface 507b on the inner surface 503a in the side area, wherein the abutment surface 507b may be designed for the plunger boss 1040.2 (see Fig.10 ) rests thereon. The groove rib 507 may further include an optional first slope 507c and an optional second slope 507d, the first slope and the second slope may interact with the plunger 1000, for example with the plunger boss 1040.3, such as Figure 10G and Fig. 10HAn optional first ramp 507c may be located at the transition from the proximal groove 506a to the distal groove 506b and may interact with the plunger boss 1040.3, see Figure 10G and Fig. 10H In the unlikely event that the plunger 1000 does not rotate spontaneously (e.g., when the needle shield is in the second position), the first ramp 507c may interact with the plunger boss 1040.3, see Figure 10G and Fig. 10H , so as to further promote or activate the rotation of the plunger 1000. The second ramp 507d can be located at the proximal end of the side region 503 and can be designed to facilitate the activation of the plunger 1000 during the final assembly of the drug delivery device 100, for example by acting on the plunger boss 1040.3, such as Figure 10G and Fig. 10H As displayed.

[0325] As in Figure 5 As can be seen in the figure, the needle shield 500 can include plunger guide ribs 508 on the inner surface 503a in the side region, which are designed to provide angular guidance to the plunger 1000, for example, with respect to one or both of the bosses 1040.2 and 1040.3. In addition, the needle shield 500 can have grooves 509 on the outer surface 503b in the side region. These grooves can be provided to reduce part warpage during and / or after injection molding when manufacturing the needle shield 500. Mechanical stability can also be improved by the grooves 509.

[0326] Figure 5 It is also shown that the needle shield 500 can have at least one needle shield blocking device 510. The needle shield blocking device 510 can be offset 90 degrees relative to each cap clip window 504 in the rotation direction. The needle shield blocking device 510 can be embodied as a flexible arm 510 that can be elastically pivoted, and these flexible arms are offset or can be offset in the radial direction away from the longitudinal axis in the assembled state of the device 100. The needle shield 500 can have several flexible arms 510. For example, the needle shield 500 can have one, two, three, four, five, six, seven, eight or more flexible arms 510. The flexible arms 510 can be evenly distributed along the circumference of the needle shield 500. In addition, the flexible arms 510 are arranged relative to each other. After the drug delivery operation has been completed, the drug delivery device 100 can be removed from the user's skin. The needle shield 500 can be biased toward the first shield position X relative to the device body 700 by the needle shield spring 600. Thus, when the drug delivery device 100 is removed from the skin, the needle shield 500 can be moved relative to the device body 700 toward the first shield position X, e.g. beyond its first shield position X, into a final locked or third shield position Z, e.g. Figure 1DIn the third shield position Z, needle shield 500 can be properly locked relative to device body 700 axially to resist moving in the proximal direction by the locking engagement between the flexible arm 510 of needle shield 500 and the associated protrusion of device body 700 (for example, the needle shield locking structure 720 on the inner surface of the side wall 700a of device body 700). Needle shield locking structure 720 may also be referred to as blocking element 720 or ramp-shaped element 720. Because needle shield 500 is axially locked, needle shield can no longer be displaced to the second and / or first shield position of needle shield 500 proximally relative to device body 700. This can protect the user from needle sticks after use. In addition, when needle shield 500 is in the third shield position Z, for example, due to the flexible arm 510 and / or due to the features on cap 200 (especially the features on optional cap 300), cap 200 may no longer be reattached.

[0327] like Figure 5 As shown in, the flexible arm 510 can have a (e.g., cube-shaped) protuberance 510.1 in a radial direction at its proximal region. The protuberance can protrude radially from the flexible arm. The protuberance 510.1 forms the proximal end of the flexible arm 510. The protuberance can also be referred to as a stop surface. In the circumferential direction, the protuberance 510.1 can extend farther than the axial direction along the needle shield 500. Due to the cubic shape and the height difference along the radial direction relative to the remaining outer surface of the flexible arm, the flexible arm has an edge in the distal direction and in the proximal direction. The protuberance 510.1 of the flexible arm 510 can engage with the corresponding protrusion at the circumferential inner surface of the device body 700 to lock the needle shield 500, resisting axial movement relative to the device body 700 (e.g., in the third shield position Z). It should be noted that in the present disclosure, the first shield position X is also referred to as the intermediate position X, and the third shield position Z is also referred to as the initial position Z. For example, when the needle shield is in the third shield position Z, one surface of the protrusion 510.1 (e.g., the surface pointing in the proximal direction P) may abut against the distal surface of the needle shield locking structure 720. Therefore, the needle shield 500 is restricted from moving proximally relative to the device body 700. In other words, the protrusion 510.1 and the needle shield locking structure 720 provide a post-use needle shield locking mechanism, thereby preventing the user from being injured by preventing the needle tip from being exposed.

[0328] For example, if the proximal force applied to the needle shield 500 is less than 60N, preferably less than 50N, and more preferably less than 40N, use of the rear needle shield locking mechanism may prevent the needle shield 500 from moving proximally relative to the device body 700.

[0329] In the present disclosure, the protrusion 510.1 may also be referred to as a stop surface 510.1. The flexible arm 510 may also have a web 510.2, such as Figure 5As shown in . In the present disclosure, the web 510.2 may also be referred to as a protrusion 510.2. The web 510.2 may have a free end in the distal direction, which may be chamfered. The relatively proximal end of the web may transition to a ridge. The height of the web 510.2 in the radial direction may be lower than the height of the ridge 510.1, or the same height as the ridge 510.1. The web 510.2 may interact with the needle shield locking structure 720 of the device body 700 (see also Figure 4H ). For example, the web 510.2 may interact with a recess of the needle shield locking structure 720 to prevent rotational movement of the needle shield 500 relative to the device body 700. Alternatively or additionally, due to this interaction, the degree of inward deflection required of the flexible arm 510 may be reduced when the flexible arm 510 moves along the needle shield locking structure 720, for example when the needle shield 500 moves from its second shield position Y to its third shield position Z relative to the device body 700. This reduces the load on the flexible arm.

[0330] like Figure 5 As shown in the figure, the flexible arm 510 has a recess 510.3 at its interface with the rest of the needle shield body. The circular recess 510.3 can be a circular material recess. The material recess provides an articulation area between the flexible arm 510 and the rest of the needle shield body. The area of ​​the needle shield adjacent to the flexible arm (e.g., the distal portion 502) can be a cylindrical sleeve-shaped area of ​​the needle shield. Preferably, in any one position of the needle shield relative to the device body, only this area protrudes from the device body.

[0331] In addition, the needle shield 500 may move slightly in the distal direction immediately after the cap 200 is removed, but before the needle shield 500 is placed on the skin surface and before the energy of the plunger 1000 and the drive spring 1100 is released. In this case, the needle shield 500 slides slightly forward because the needle shield spring 600 is released and the plunger 1000 is rotated to a ready-to-use position. In particular, this may occur when the cap 200 is directly engaged with the device body 700 of the drug delivery device 100 or the device body 700 and the needle shield (biased by the needle shield spring) abut the cap before the cap is removed.

[0332] It should be noted that all features of the needle shield 500, namely, in particular, the skin contact surface 501, the distal portion 502, the side region 503, the side region inner surface 503a, the side region outer surface 503b, the cap clip window 504, the front stop groove 505, the plunger boss groove 506, the proximal groove 506a, the distal groove 506b, the groove rib 507, the shoulder 507a, the abutment surface 507b, the first ramp 507c, the second ramp 507d, the plunger guide rib 508, the groove 509 and the flexible arm 510 can be an integral part of the needle shield 500. Accordingly, the needle shield 500 and all its features can represent a one-piece component. However, a two-part or multi-part needle shield 500 can also be used.

[0333] 6. Needle cover spring ( Fig. 6A , Figure 6B )

[0334] Fig. 6A and Figure 6B A needle shield spring 600 is shown. Figure 6B As shown, the needle shield spring 600 can extend between the needle shield 500 and the device body 700 (described below). For example, the needle shield spring 600 can extend between the proximally facing surface of the needle shield 500 and the distally facing surface of the central support structure 701 of the device body 700. More specifically, the needle shield spring 600 can extend between the proximally facing inner surface of the distal portion 502 of the needle shield 500 and the needle shield spring support 708a of the device body 700 as described below.

[0335] In one embodiment, the needle shield spring 600, in particular, its proximal end, can be supported in a radially outward direction by a needle shield rear stopper 721 (described below) of the device body 700. In other words, the needle shield spring 600 can be prevented from tilting relative to the device body 700 and / or the needle shield spring 600 can be prevented from deflecting radially outward by the needle shield rear stopper 721.

[0336] The needle shield spring 600 can be configured to provide a force to the needle shield 500. This force biases the needle shield 500 in the distal direction D. The needle shield spring 600 can be configured so that when a force less than the needle shield spring force is applied to the needle shield in the proximal direction P, for example when the drug delivery device 100 is removed from the user's skin after injection, or when the injection is interrupted, the needle shield spring force can push the needle shield 500 distally. In addition, the needle shield spring 600 can be configured to ensure that the device 100 can only be activated if the needle shield 500 is pressed against the user's skin with sufficient force. In other words, if the user does not press the needle shield 500 against the injection site with sufficient force, the drug delivery device 100 is not activated / triggered. Therefore, the needle shield spring 600 can be configured so that the minimum activation force requirement is met. For example, the minimum force required to activate the drug delivery device can be between 1N (Newton) and 50N, preferably less than 20N.

[0337] In one embodiment, the needle shield spring 600 can be made of high strength stainless steel. For example, the needle shield spring 600 can be made of austenitic steel having sufficient elasticity to allow the needle shield spring 600 to be elastically compressed. In one embodiment, the needle shield spring 600 can be made of austenitic chrome-nickel steel. In one embodiment, the needle shield spring 600 can be made of DIN EN 1.4310 steel.

[0338] In one embodiment, the length of needle shield spring 600 may be selected so that a smooth force curve may be obtained and excessive activation forces may be avoided.

[0339] In one embodiment, the needle shield spring 600 can be made of coiled wire. The wire diameter can be selected based on the stress experienced when the needle shield spring 600 is compressed. Further, the wire can be soap lubricated wire to aid in manufacturability.

[0340] In one embodiment, the needle shield spring 600 may have 5 to 50 turns, preferably 5 to 25 turns, and more preferably 10 turns. The outer diameter of the turns may be selected according to the geometry of the needle shield 500, in particular the flexible arm 510 of the needle shield 500, so that when the flexible arm 510 deflects on the needle shield locking structure and the needle shield spring 600 surrounds the axial support front end 703 of the device body 700, collision with the flexible arm 510 can be avoided.

[0341] In one embodiment, the outer diameter of the ring can be between 5mm and 20mm, preferably between 10mm and 15mm, more preferably between 12mm and 14mm, for example, 13mm. The inner diameter of the ring can be between 5mm and 20mm, preferably between 10mm and 15mm, more preferably between 11mm and 13mm, for example, 12mm.

[0342] In one embodiment, the coiled wire may have a double or triple winding 601 at its end. The double or triple winding 601 may be formed by two or three windings that are axially in contact with each other along their circumference. The double or triple winding 601 may provide a contact surface for the needle shield spring 600 to firmly contact the needle shield 500 and the device body 700.

[0343] In one embodiment, the length of the needle shield spring 600 may be between 30 mm and 100 mm. In one embodiment, the length of the needle shield spring 600 may be between 50 mm and 80 mm. In one embodiment, the length of the needle shield spring 600 may be between 60 mm and 70 mm, preferably 66 mm.

[0344] 7.Device body ( FIG. 7A to FIG. 7G )

[0345] Fig. 7A and Figure 7B A device body 700 according to an embodiment of the present disclosure is shown. The device body 700 may be a main housing of the drug delivery device 100. The device body 700 may provide a space for accommodating some or all of the components of the drug delivery device 100.

[0346] The device body 700 may have a cylindrical shape. In other words, the device body may have a distal end and a proximal end connected to each other by a sidewall 700a. The sidewall 700a defines a cross-sectional area of ​​the device body 700. The cross-sectional area may be substantially constant along the axial length of the device body 700. Optionally, the cross-sectional area may increase toward the distal end, so that the cross-sectional area at the distal end may be greater than the cross-sectional area at the proximal end.

[0347] In one embodiment, the cross-sectional area can increase from the drug window 710 (sidewall window) in the sidewall 700a, for example, from the middle to the distal end thereof. The increase can be linear or non-linear (e.g., parabolic), so that the outer surface of the sidewall 700a of the device body 700 can be curved toward the distal end.

[0348] At its proximal end, the device body 700 includes a proximal aperture 730. The proximal aperture 730 may be defined by a proximal edge 732 of the sidewall 700a.

[0349] The sidewall 700 a may provide a user gripping surface that allows a user to manipulate and / or operate the drug delivery device 100 .

[0350] The side wall 700a of the device body 700 may include at least one opening. The opening may be a medication window 710. The medication window 710 may be arranged in the distal half of the side wall 700a, preferably in the fourth and / or fifth segments thereof when the axial length of the side wall 700a measured from the proximal end is assumed to be divided into six equal length segments. The medication window 710 may be an elongated window that extends longer in the axial direction than in the circumferential direction. On the outer surface, the side wall may further include a portion for labeling.

[0351] Through the medication window 710, the user may be able to see the plunger stop 910 and / or the plunger 1000 (described below) of the syringe 900 (described below). Through the medication window 710, the user may further see the medication Dr before and during injection. For example, during operation of the medication delivery device 100, the user may first see the medication Dr and the barrel 902 of the syringe 900 (described below), which may be a pre-filled syringe containing the medication Dr. During injection, the user may see the plunger stop 910 and then see the plunger 1000 moving in the distal direction D inside the barrel 902.

[0352] The outer surface of the side wall 700a and / or the inner surface of the side wall may include interaction elements for supporting other components of the drug delivery device 100, such as the cap 200 and / or the needle shield 500 and / or the syringe holder 800 (described below) and / or the drive spring holder 1200 (described below). The interaction elements may be primarily arranged on the inner surface of the side wall 700a and may include elements such as ribs, grooves, protrusions, notches, etc., which enable physical interaction with corresponding features of other components of the drug delivery device 100.

[0353] In one embodiment, the side wall 700a may further include a first body connection structure. The first body connection structure may include at least one, preferably at least two recesses. Fig. 7A As shown, the recess can be a proximal cutout 714. The proximal cutout 714 can be arranged to be proximally offset relative to the medication window 710, for example, near the proximal end of the device body. For example, when measured from the proximal end, the proximal cutout 714 can be arranged in the first 20% or the first 10% of the length of the sidewall 700a. The proximal cutouts 714 can be offset from each other by 180 degrees in the circumferential direction of the device body 700. At least one of the proximal cutouts 714 can overlap with the medication window 710 in the circumferential direction.

[0354] As described below, for example, in Section 12, the proximal notch 714 can interact with the snap projection 1203.2 of the snap arm 1203 of the drive spring holder 1200, for example, when the drive spring holder is in the (first) drive spring holder position (closed portion position). Further, as described below, the proximal notch 714 can interact with the retaining clip 806 of the syringe holder 800, for example, when the syringe holder 800 is in the first syringe holder position (first container holder position).

[0355] The side wall 700a may further include an injection molding gate recess 712. The injection molding gate recess 712 may be formed at the outer surface of the side wall 700a. The injection molding gate recess 712 does not penetrate the side wall 700a. The injection molding gate recess 712 may be offset distally relative to the proximal cutout 714. The injection molding gate recess 712 may be offset proximally relative to the drug window 710. In one embodiment, the injection molding gate recess 712 may be arranged near the middle of the side wall 700a or in the middle of the side wall along the axial direction of the device body 700.

[0356] In one embodiment, the side wall 700a may further include a second body connection structure. The second body connection structure may include at least one, preferably at least two recesses. Fig. 7A As shown, the recess can be a distal cutout 713. The distal cutout 713 can be arranged to be offset proximally relative to the drug window 710. The distal cutout 713 can be offset distally relative to the injection molding gate recess 712. The distal cutout 713 can be offset distally relative to the proximal cutout 714. In one embodiment, the distal cutout 713 can be arranged in the middle or near the middle of the sidewall 700a in the axial direction. The distal cutouts 714 can be angularly offset 180 degrees from each other.

[0357] The proximal incision 714 can be larger than the distal incision 713. In other words, the proximal incision 714 can extend further along at least one spatial direction than the distal incision 713. In one embodiment, at least at least one of the distal incisions 713 can be aligned with at least one proximal incision 714.

[0358] At least one, preferably all, of the distal incisions 713 may overlap with a corresponding number of proximal incisions 714 in the circumferential direction. The overlap may be a partial overlap. Preferably, the proximal incisions 714 completely overlap with the distal incisions 713 in the circumferential direction. Further, at least one of the distal incisions 713 may overlap or align with the drug window 710 in the circumferential direction.

[0359] As described below, the distal cutout 713 may interact with a retaining clip 806 of a syringe holder 800. Thus, the syringe holder 800 may be secured to the device body 700, for example in a second syringe holder position (second container holder position).

[0360] The cutouts 713 and / or 714 may be arranged to be offset relative to a centerline between the retainer guide ribs 726 (described in more detail below). Alternatively or additionally, the cutouts 713, 714 may be offset relative to a longitudinal centerline of the medication window 710 extending in the axial direction, such as Fig. 7A and Fig.17 Alternatively or additionally, the cutout 713 and / or 714 may be arranged in the middle between the holder guide ribs 726, ie centered.

[0361] The device body 700 may include an on-body user indicator 733 at an outer surface of the sidewall 700a. The on-body user indicator 733 may be configured to indicate to a user the position of the device body 700 relative to other components of the drug delivery device 100 (eg, the cap 200).

[0362] When the sidewall 700a is labeled, the injection molding gate recess 712 and / or the cutouts 713, 714 may be hidden by the label so that at least one of these features, at least two of these features, or all of these features are not visible to the user. This may provide comfort to the user.

[0363] The device body 700 can be formed of polycarbonate (PC) Makrolon 2258 (a medical grade PC) or other materials. PC can be selected mainly for its strength, flexibility, toughness and its strength at high temperatures, thereby allowing for shorter injection molding cycle times, thus allowing for lower part costs.

[0364] like Figure 7B As shown in , certain features of the device body 700 can form a syringe support mechanism. The syringe support mechanism can be formed inside the device body 700. The syringe support mechanism can be configured to position the syringe 900 in the device body 700 so that the needle extension requirement is met. The needle extension requirement can be, for example, that the distal end of the needle 908 of the syringe 900 extends beyond a certain length of the distal end of the device body, for example, between 4 millimeters (mm) and 8 mm, while bearing the impact load caused by the impact of the plunger 1000 on the plunger stop 910 of the syringe 900 at the beginning of the injection.

[0365] In one embodiment, the syringe support mechanism is configured to support a syringe (e.g., a prefilled syringe 900) in the device body 700, e.g., against distal movement relative to the device body 700. In one embodiment, the syringe support mechanism can be configured to support the shoulder 904 of the syringe 900. Thus, manufacturing tolerances can be better compensated for compared to designs that support the proximal flange 912 of the syringe 900. This allows for less variability in the amount of extension of the distal end of the needle beyond the device body 700 when the syringe 900 is in the final assembly position in the device body 700.

[0366] A specifically designed assembly process may be required to ensure that the components reach their correct final positions and that the syringe 900 is properly supported.

[0367] like Figure 7C As shown, the syringe support mechanism may include a central support structure 701 formed within the device body 700. In one embodiment, the central support structure 701 may be configured to support the barrel 902 of the syringe 900, such as supporting the shoulder 904. In one embodiment, as shown in FIG. Fig.7D and Fig. 7E As shown, the central support structure 701 can be configured to support the syringe holder 800.

[0368] The central support structure 701 may include a central tube 702 configured to support the barrel 902 of the syringe 900 in a radial direction (see Figure 7C ) or syringe holder 800 (not shown). In one embodiment, the central tube 702 may have a non-closed circumference, for example, the central tube may include at least one axial recess extending in the axial direction of the central tube 702. The axial length of the central tube 702 may exceed half or more than three quarters of the axial length of the barrel 902 of the syringe 900 (for example, when measured from the shoulder 904 to the distal surface of the syringe flange 912 (not shown)).

[0369] The central support structure 701 may include an axial support front end 703 configured to support the syringe 900 in an axial direction, such as against distal movement relative to the device body 700. The axial support front end 703 may be formed at the distal end of the central tube 702.

[0370] In one embodiment, the axial support front end 703 may include a radially inwardly extending protrusion 704 at its distal end. The axial support front end 703 and the radial protrusion 704 may interact with the shoulder 904 of the syringe 900, thereby preventing the syringe 900 from moving distally beyond the axial support front end 703, in particular beyond the protrusion 704. In other words, the axial support front end 703 may define the maximum distal position of the syringe 900 relative to the device body 700 and retain the syringe 900 at its desired axial position relative to the device body 700.

[0371] In one embodiment, the axial support front end 703 can have a closed circumference. Therefore, the axial support front end 703 can surround the shoulder 904. The closed circumference can enable the force to be evenly distributed over the entire contact surface. The closed circumference can also enable the axial support front end 703 to withstand higher loads and impacts in the distal and / or radial directions.

[0372] In one embodiment not shown in the drawings, the axial support front end may have a non-closed circumference, for example interrupted by at least one recess extending in the axial direction. In this embodiment, the axial support front end 703 may be thicker in the radial direction so as to be able to withstand the forces of the drug delivery device 100, such as the force of the drive spring 600, during assembly and / or operation.

[0373] In one embodiment, inner diameter 704ID of radially inward protrusion 704 may be smaller than outer diameter 902OD of barrel 902. For example, inner diameter 704ID may be at least 2%, at least 5%, at least 10%, or at least 20% smaller than outer diameter 902OD.

[0374] In such Figure 7C In one illustrated embodiment, the outer diameter 914OD of the needle shield 914 (described below) can be smaller than the inner diameter 704ID of the protrusion 704, thereby allowing the needle shield 914 to move distally beyond the protrusion 704. For example, the outer diameter 914OD can be at least 2%, at least 5%, at least 10%, or at least 20% smaller than the inner diameter 704ID of the protrusion 704. The outer diameter 914OD of the needle shield 914 can be smaller than the outer diameter 902OD of the barrel 902. Additional details regarding the syringe 900 are described in Section 9 below.

[0375] In such Fig.7DIn one embodiment shown, the outer diameter 914OD of the needle shield 914 can be larger than the outer diameter 902OD of the barrel 902, for example, at least 2%, at least 5%, at least 10%, or at least 20%. This may require the use of a syringe holder 800 so that the syringe 900 can be assembled in the drug delivery device 100, and in particular in the device body 700. However, if the outer diameter 914OD of the needle shield 914 is equal to the outer diameter 902OD of the barrel 902, or even if the outer diameter 914OD of the needle shield 914 is smaller than the outer diameter 902OD of the barrel 902, the syringe holder 800 can be used.

[0376] In one embodiment, the axial support front end 703 can be configured to support the syringe holder 800 in the axial direction relative to the device body 700 (see Fig.7D ). For example, the axial support front end 703 can be configured to fasten the syringe holder 800 to resist distal movement relative to the device body 700. In particular, the axial support front end 703 can be configured to surround the flexible holder arm 801 of the syringe holder 800. The radially inward projection 704 can form an abutment surface for the holder projection 803. The axial support front end 703 can have a closed circumference. Therefore, the axial support front end 703 can surround the holder arm 801. The axial support front end 703 can have a tapered inner surface 703.1, the diameter of which decreases along the distal direction D. The tapered inner surface 703.1 can be configured to interact with the holder arm 801 when the syringe holder 800 moves distally relative to the device body 700. Therefore, the tapered inner surface 703.1 can limit the radial outward movement of the holder arm 801 or even cause the holder arm 801 to deflect radially inward. With regard to additional details of certain interactions between the device body 700 and the syringe holder 800, the above-described interactions between the device body 700 and the syringe 900 apply thereto, and vice versa where technically feasible.

[0377] The central support structure 701 (particularly the central tube 702 thereof) may include at least one central support window 709 (see Fig. 7E ). The central support window 709 can be aligned with or at least partially overlap the drug window 710 to allow inspection of the syringe 900, the drug within the syringe 900, the plunger stop 910, and / or the plunger 1000, for example, during assembly and / or injection. If a syringe holder 800 is used in the drug delivery device 100, the central support window 709 can be aligned with or at least partially overlap the holder window 808 (described below).

[0378] The central support structure 701 is connected to the side wall 700a of the device body 700 by at least one connecting element. The connecting element may include at least one connecting rib 708 extending from the inner surface of the side wall 700a to the outer surface of the central support structure 701. The connecting rib 708 may further extend in the axial direction of the device body 700. For example, the connecting rib 708 may extend along at least 50%, at least 60%, or at least 75% of the axial length of the central support structure 701. The connecting rib 708 may extend distally until the distal end of the axial support front end 703.

[0379] In one embodiment, there may be a plurality of connecting ribs 708, such as at least two, at least three, or at least four connecting ribs 708. The connecting ribs 708 may be arranged equidistantly in the circumferential direction of the device body 700. Alternatively, as Figure 7C shown, the connecting ribs 708 may be arranged with different angular offsets from each other. For example, two connecting ribs 708 may be connected to each other through the proximal surface and / or the distal surface of the drug window 710, which extends radially from the central support 701 to the outer surface of the side wall 700a. The angular offset between two connected connecting ribs 708 may be less than 90 degrees, such as less than 80 degrees, less than 70 degrees, or less than 50 degrees. Therefore, the angular offset between two connecting ribs 708 that are not connected through the proximal surface and / or the distal surface of the drug window 710 may be greater than 90 degrees, such as greater than 100 degrees, greater than 110 degrees, or greater than 130 degrees. The connection configuration is only explained by way of example. Similar angular offsets of the connecting ribs 708 are possible even if the connecting ribs 708 are not connected to each other.

[0380] Therefore, the contact between the needle shield 500 and the device body 700 can be improved, thereby improving the axial and / or rotational stability of the needle shield 500 inside the device body 700.

[0381] At the radially inner section, at least one, preferably all, of the connecting ribs 708 may form a needle shield spring support 708a. In this context, the radially inner section is the section of the connecting rib 708 that is connected to the central support structure 701. In other words, the radially inner section is the section that is more radially inward than the section connected to the inner surface of the side wall 700a. The needle shield spring support 708a may interact with the needle shield spring 600 (such as its proximal end) to support the needle shield spring 600 in the axial direction.

[0382] The illustrated embodiment includes four connecting ribs 708 that extend in the axial direction of the central support structure 701, such as from the proximal end of the central support structure 701 to the axial support front end 703. In other words, the illustrated central support structure 701 may be connected to the side wall 701a along at least 70% to 95% of its axial length.

[0383] According to an embodiment not shown, instead of the central tube 702, the syringe support mechanism may include at least two, at least three, or at least four support arms extending in the axial direction of the device body 700. The support arms may be arranged equidistantly around the circumference of the central support structure 701 or arranged with different angular offsets. In the circumferential direction, the support arms may extend at different angles, depending on the number of support arms. For example, if there are two support arms, each support arm may cover an arc of less than 90 degrees of the central tube 702. Thus, the angle between the support arms may be 90 degrees or more. The support arms may be connected to each other at their distal ends, thereby forming an axial support front end as described above. All the specific features of this axial support end may be similar to the specific features described previously for the embodiment with the central tube 702 having the axial support end 703.

[0384] In one embodiment, the proximal incision 714 is configured to form a space into which the latching protrusion 1203.2 of the latching arm 1203 of the drive spring holder 1200 can deflect when aligned with the proximal incision 714. In other words, the latching arm 1203 and the incision 714 may form a housing latching mechanism.

[0385] The housing latching mechanism may fasten the drive spring holder 1200 to the device body 700, thereby preventing the drug delivery device 100 from being disassembled by the user at the start of injection or under the impact load of the drive spring 1100 (e.g., when the plunger 1000 contacts the plunger stopper 910). In particular, when the latching arm 1203 interacts with the proximal incision 714, axial movement of the drive spring holder 1200 relative to the device body 700 may be restricted, preferably avoided. Thus, the drive spring holder 1200 may be in a first drive spring holder position (which may be a closure position). Alternatively or additionally, when the latching arm 1203 interacts with the proximal incision 714, rotational movement of the drive spring holder 1200 relative to the device body 700 may be restricted, preferably avoided. In other words, in the closure position, the drive spring holder 1200 may be fastened to the device body 700 to resist axial and / or rotational movement.

[0386] In one embodiment, if the device body 700 is for a drug delivery device 100 having a syringe holder 800, the proximal incision 714 may interact with the retaining clip 806 of the syringe holder 800 when the syringe holder 800 is moved distally from the proximal end into the device body 700 (e.g., through the proximal orifice 730).

[0387] As described below, when the retention clip 806 is aligned with the proximal incision 714, the retention clip 806 deflects radially outward into the proximal incision 714 and secures the syringe holder 800 to the device body at the first container holder position. The first container holder position may be the first engagement position of the syringe holder 800, as described below. In other words, during assembly of the syringe holder 800 in the device body 700, the proximal incision 714 provides space for the retention clip 806.

[0388] When a distally-directed force is applied to the syringe holder 800, the retention clip 806 may deflect radially inward due to interaction with the inner surface of the sidewall 700a, thereby disengaging from the proximal incision 714. Accordingly, the syringe holder 800 is free to move further distally within the device body 700. When the retention clip 806 is aligned with the distal incision 713, the retention clip 806 may deflect radially outward into the space provided by the distal incision 713, thereby locking the syringe holder 800 relative to the device body 700 at the second container holder position. The second container holder position may be the second engagement position of the syringe holder 800, as described below.

[0389] In one embodiment, the device body 700 may include a needle shield positioning structure. The needle shield positioning structure may include at least one needle shield front stop 724. The needle shield front stop 724 may include at least one protrusion that projects radially inward from the inner surface of the sidewall 700a of the device body 700. The needle shield front stop 724 may include a ramp-shaped section 724.1 that is radially inwardly inclined in the proximal direction P and a cube section 724.2 (see Figure 7F ). The cube section 724.2 may be disposed proximal to the ramp-shaped section 724.1. The cube section 724.2 may project the same distance radially inward as the proximal end of the ramp-shaped section 724.1. Alternatively, the cube section 724.2 may project more or less radially inward than the ramp-shaped section 724.1.

[0390] The needle shield front stop 724 can be configured to interact with corresponding fastening features of the needle shield 500. The fastening feature can be the front stop groove 505 of the needle shield 500. In particular, when the needle shield 500 moves distally relative to the device body 700, such as from the second shield position Y to the third shield position Z as described above, the distal-facing surface of the front stop groove 505 can abut against the proximal-facing surface of the cube section 724.2. Accordingly, the needle shield front stop 724 is configured to provide a limit to the distal movement of the needle shield 500 relative to the device body 700. In other words, when the needle shield 500 is in its final position relative to the device body 700, such as after use, the maximum distal extension of the needle shield 500 beyond the distal end of the device body 700 is defined by the interaction between the front stop groove 505 and the needle shield front stop 724.

[0391] The ramped section 724.1 can be configured to radially deflect the side region 503 of the needle shield 500 inwardly when the needle shield 500 is inserted into the device body 700, thereby enabling the needle shield 500 to be assembled within the device body 700. The cube section 724.2 can provide additional axial strength to the needle shield front stop 724, thereby improving the stability of the device body 700. For example, this can be beneficial for withstanding the distal force applied to the needle shield 500 by the needle shield spring 600.

[0392] In one embodiment, the device body 700 can include a needle shield rear stop 721. The needle shield rear stop 721 can be formed at the distal end of at least one connecting rib 708. As Figure 7C shown, the needle shield rear stop 721 can be disposed at an outer section of the connecting rib 708, where the connecting rib 708 is connected to the inner surface of the side wall 700a. The needle shield rear stop 721 includes a distal surface that can extend to the distal end of the axial support front end 703. When the needle shield 500 moves proximally relative to the device body 700, such as when the skin contact surface 501 presses against the user's skin with sufficient force as described above, the distal surface can interact with the needle shield 500, such as with the proximal-facing surface of the recess between the side region 503 and the flexible arm 510. Accordingly, the needle shield rear stop 721 can define the maximum proximal position of the needle shield 500 relative to the device body 700.

[0393] Figure 7C and Figure 7F the illustrated embodiment includes four connecting ribs 708, each having a needle shield rear stop 721 as previously described. The needle shield rear stop 721 extends distally from the connecting rib 708 beyond the needle shield spring support 708a, such as until the protrusion 704 (see also Figure 6B ). Alternatively, the needle shield rear stop 721 can extend further distally or proximally.

[0394] In one embodiment, the device body 700 may include a needle shield locking structure 720. The needle shield locking structure 720 may include at least one protrusion that projects radially inward from the inner surface of the side wall 700a of the device body 700, such as one or more ramp-shaped elements 720 (see Figure 7B , Figure 7C and Figure 7F ). The ramp-shaped element 720 may be radially inwardly inclined in the distal direction D.

[0395] The needle shield locking structure 720 may be disposed near the distal end of the device body 700, such as within the last 30%, last 20%, or last 10% of the axial length of the device body 700 when measured from the edge 732 to the distal end. The needle shield locking structure 720 may be circumferentially aligned with the drug window 710. The needle shield locking structure 720 may be distal to the drug window 710. The needle shield locking structure 720 may interact with the flexible arm 510 on the needle shield 500 (as described above and below). Due to this interaction, when the needle shield 500 is in the distal position relative to the device body 700 (e.g., after injection), proximal movement of the needle shield 500 relative to the device body 700 may be restricted, preferably avoided. In other words, the interaction may provide a dose end locking function.

[0396] In Figure 7B , Figure 7C and Figure 7F the illustrated embodiment, the needle shield locking structure 720 may include at least one ramp-shaped element 720. The ramp-shaped element 720 may be offset axially relative to the needle shield front stop 724. Preferably, the ramp-shaped element 720 may be distally offset relative to the needle shield front stop 724.

[0397] Since the ramp-shaped element 720 is radially inwardly inclined in the distal direction D, when the needle shield 500 moves distally relative to the device body 700 and the flexible arm 510 is proximal to the ramp-shaped element 720, the flexible arm 510 deflects radially inward. After passing the ramp-shaped element 720, the flexible arm 510 may return to its relaxed state by deflecting radially outward. Thus, the proximal surface of the cubic-shaped bulge 510.1 interacts with the distal surface 720a of the ramp-shaped element 720. For example, the distal surface 720a of the ramp-shaped element 720 may be perpendicular to the axial direction or only slightly inclined to the axial direction, such that when a force in the proximal direction P is applied to the needle shield 500, the sliding of the cubic-shaped bulge 510.1 along the distal surface is restricted. In other words, the needle shield 500 is locked against proximal movement relative to the device body 700 by the interaction of its cubic-shaped bulge 510.1 with the distal surface of the ramp-shaped element 720.

[0398] In one embodiment as shown in Figure 7G , the needle shield locking structure 720 includes four ramp-shaped elements 720, grouped into two pairs. In other words, the needle shield locking structure 720 includes two double ramps, each double ramp being constituted by two ramp-shaped elements 720. The ramp-shaped elements 720 may be offset distally relative to the drug window 710 (see Figure 7F ). Each pair of ramp-shaped elements 720 may be circumferentially aligned with the drug window 710. The two ramp-shaped elements 720 in a pair may be arranged such that the angle therebetween in the circumferential direction is less than 90 degrees, preferably less than 45 degrees. A space may be formed between the two ramp-shaped elements in a pair. In the circumferential direction, each pair may be aligned with the flexible arm 510 of the needle shield 500 such that when the needle shield 500 is moved distally relative to the device body 700, the web 510.2 of the needle shield 500 is guided between the two ramp-shaped elements (as described above). Further, since the web 510.2 extends into the space between the ramp-shaped elements 720, the radially inward deflection of the flexible arm 510 is relatively small when sliding along the ramp-shaped elements 720.

[0399] The two pairs of ramp-shaped elements 720 may be angularly offset from each other, for example, by 180 degrees. Further, the two pairs may be angularly offset relative to the needle shield front stop 724, for example, by 90 degrees.

[0400] After the cubic-shaped protrusion 510.1 has passed the distal end of the ramp-shaped element 720, the flexible arm 510 deflects radially outward. Thus, when a force in the proximal direction is applied to the needle shield 500 after use, the proximal surface of the cubic-shaped protrusion 510.1 interacts with the distal surface of the ramp-shaped element 720 (see Figure 7G ). Due to the interaction, the needle shield 500 is prevented from moving proximally relative to the device body 700, which is the post-use needle shield locking mechanism.

[0401] In Figure 7B , Figure 7C , Figure 7F and Figure 7GIn the illustrated embodiment, the device body 700 includes two needle shield front stoppers 724, and the needle shield locking structure 720 is formed by four ramp-shaped elements 720. However, there may be more or fewer than two needle shield front stoppers 724 and more or fewer than four ramp-shaped elements 720. The needle shield front stoppers 724 may be angularly offset relative to the ramp-shaped elements 720, for example, offset by 90 degrees or more or less, depending on the geometry of the needle shield 500 and / or the number of ramp-shaped elements 720 and / or the number of front stoppers 724. The ramp-shaped elements 720 may be grouped, for example, in pairs, such that the paired ramp-shaped elements 720 are angularly offset relative to each other in the circumferential direction, preferably such that each pair is arranged equidistantly in the circumferential direction. For example, the angle between two pairs may be 180 degrees. Each pair of ramp-shaped elements 720 may be offset 90 degrees in the circumferential direction relative to each needle shield front stopper 724. Thus, the paired ramp-shaped elements 720 and the needle shield front stoppers 724 may be arranged equidistantly around the circumference of the inner surface of the side wall 700a. For example, there may be two pairs of ramp-shaped structures 720, which are angularly offset 90 degrees relative to the needle shield front stoppers 724, while the front stoppers are angularly offset 180 degrees from each other. The needle shield front stoppers 724 may be arranged to be proximally offset relative to the ramp-shaped elements 720.

[0402] In one embodiment, the needle shield front stopper 724 may be arranged to have a 90-degree angular offset relative to the drug window 710. The needle shield front stopper 724 may at least partially overlap the drug window 710 in the axial direction (see Fig.7D ).

[0403] In one embodiment, the device body 700 may include a needle shield locking anti-disengagement structure 720.1. The needle shield locking anti-disengagement structure 720.1 may include a protrusion, such as a rib 720.1, which protrudes radially inward from the inner surface of the side wall 700a and extends in the longitudinal direction of the device body 700 (see Figure 7C ). The needle shield locking anti-disengagement structure 720.1 is configured to limit deformation of the needle shield 500 relative to the device body 700 when the needle shield 500 interacts with the needle shield locking structure 720 and / or the needle shield front stopper 724. This may limit the risk of the needle shield 500, particularly the cubic protrusion 510.2 or groove 505 of the flexible arm 510, disengaging from the needle shield locking structure 720 or the front stopper 724 when the device body 700 is deformed relative to the needle shield 500 (e.g., due to the body dropping or being squeezed by the user). Additionally, the needle shield locking anti-disengagement structure 720.1 may provide stiffness to the side wall 700a.

[0404] As Figure 7C and Figure 7FAs shown, the needle shield locking and anti - detachment structure 720.1 can include eight elements, such as eight ribs 720.1, which are arranged at the side wall 700a with different angular offsets. The ribs 720.1 can be arranged such that a pair of ribs 720.1 can be angularly offset relative to two single ribs 720.1. For example, in each half of the circumference of the side wall 700a, a pair of ribs 720.1 can be circumferentially surrounded by two single ribs 720.1. The ribs 720.1 can extend in the proximal direction from the proximal end of the ramp - shaped element 720. In one embodiment (not shown), the ribs 720.1 can overlap with the ramp - shaped structure 720 and / or the front stop 724 in the axial direction.

[0405] In the proximal direction, the amount of radial inward extension of the ribs 720.1 from the side wall 700a can decrease. In one embodiment, the ribs 720.1 can transition to the inner surface of the side wall 700a, for example, at a portion that axially overlaps with the central support window 709. For example, the amount of radial inward extension from the side wall 700a can become zero at an axial position corresponding to the proximal end of the central support window 709 or the proximal end of the needle shield front stop 724.

[0406] In one embodiment, the device body 700 can include at least one needle shield guiding rib 723 (see Figure 7C ). The needle shield guiding rib 723 can be configured to prevent the needle shield 500 from rotating relative to the device body 700. For example, the needle shield guiding rib 723 can interact with the side region 503 of the needle shield (such as with the lateral edge 503.1 of the side region 503), thereby preventing the needle shield 500 from rotating relative to the device body 700. The needle shield guiding rib 723 can be formed on the circumferentially - facing surface of at least one, several, or all of the connecting ribs 708. The needle shield guiding rib 723 can extend in the axial direction of the central support structure 701. For example, the needle shield guiding rib 723 can axially extend from the proximal end of the axial support front end 703 until the distal end of the holder guiding rib 726 (described below). As long as the needle shield guiding rib 723 is arranged to interact with the needle shield along the entire axial movement of the needle shield 500 relative to the device body 700 and provide rotational support for the needle shield, other axial extension amounts (such as with reference to the central support window 709) are also possible. The needle shield guiding rib 723 can have a triangular cross - section such that the surface of the needle shield guiding rib 723 that mainly extends in the circumferential direction can be shorter than the surface that mainly extends in the radial direction. Thus, a larger interaction surface can be formed for interacting with the lateral edge 503.1 of the side region 503. This can be beneficial for preventing the lateral edge 503.1 from disengaging from the needle shield guiding rib 723.

[0407] In one embodiment, the needle shield guiding rib 723 is formed on the circumferential surface (lateral side) of the connecting rib 708, e.g., facing the circumferential surface of the needle shield radial support rib 722 (described below) and / or facing one rib 720.1 of the needle shield locking anti - detachment structure.

[0408] In one embodiment, the device body 700 may further include at least one needle shield radial support rib 722 (see Figure 7C ). The needle shield radial support rib 722 may be configured to support the side region 503 of the needle shield 500 such that the side region 503 is prevented from deflecting radially inwards. This may be particularly relevant when the device body 700 is deformed (e.g., squeezed). In such a case, the portion of the needle shield 500 extending inside the device body 700 may also be deformed. This may cause the lateral edge 503.1 to disengage from the needle shield guiding rib 723 or the cubic - shaped protrusion 510.1 to disengage from the needle shield locking structure 720, both of which are potentially dangerous to the user or affect the normal function of the drug delivery device.

[0409] As shown, the needle shield radial support rib 722 may extend radially outwards from the central support structure 701. In the axial direction, the needle shield radial support rib 722 may extend along the same length as the needle shield guiding rib 723. In the axial direction, the needle shield radial support rib 722 may at least partially overlap with the needle shield guiding rib 723. Preferably, the needle shield radial support rib 722 and the needle shield guiding rib 723 overlap over the entire axial length of the shorter of the two ribs. As Figure 7C shown, the device body 700 may include four needle shield radial support ribs 722, e.g., one needle shield radial support rib for each connecting rib 708. In the circumferential direction, the needle shield radial support ribs 722 may be arranged such that they support the side region 503 of the needle shield 500 along its circumferential extent. Preferably, in the circumferential direction, the needle shield radial support ribs 722 may be arranged such that the outermost lateral section of the side region 503 of the needle shield 500 is supported against radial inwards deflection.

[0410] In one embodiment, the needle shield radial support rib 722 may be arranged to overlap circumferentially with the needle shield locking anti - detachment structure (e.g., rib 720.1). Alternatively, the angular offset between the needle shield radial support rib 722 and the needle shield locking anti - detachment rib 720.1 may be small, e.g., less than 45 degrees, less than 20 degrees, less than 10 degrees or less than 5 degrees. A smaller offset may be advantageous as it may improve the support of the needle shield 500 in two radial directions. In other words, since the needle shield radial support rib 722 extends in the radially inwards direction and the needle shield locking anti - detachment rib 720.1 extends in the radially outwards direction, the side region 503 can be fastened against radial movement.

[0411] In one embodiment, the device body 700 may further include a syringe holder front stop 705 (see Fig.7D and Fig. 7E ). The syringe holder front stop 705 may be formed in the distal half of the central tube 702, for example, at the proximal end of the axial support front end 703. The syringe holder front stop 705 may be formed by the proximally facing surface of the central support structure 701. For example, the syringe holder front stop 705 may be formed by the distal end of an axial recess in the central tube 702. The syringe holder front stop 705 may define the final distal position of the syringe holder 800 within the device body 700. For example, when the syringe holder 800 is moved distally relative to the device body 700, such as during the assembly of the syringe holder 800 in the device body 700, the syringe holder front stop 705 may interact with a stop feature 809 (described below) of the syringe holder 800. As Fig. 7E shown, the axial centerline of the syringe holder front stop 705 parallel to the axial direction of the central support structure 701 may be offset 90 degrees relative to the axial centerlines of the central support window 709 and / or the drug window 710.

[0412] In one embodiment, the device body 700 may include at least one cap groove 725. The cap groove 725 may be formed on the inner surface of the side wall 700a. The cap groove 725 may axially extend in the proximal direction P from the distal end of the device body 700. In the circumferential direction, the cap groove 725 may extend over at least 1% of the circumference. The cap groove 725 may be configured to interact with the anti-rotation rib 205 of the cap 200, whereby, as described above, when the cap 200 is connected to the device body 700, the cap 200 is prevented from rotating relative to the device body 700. As Figure 7B and Figure 7C shown, the device body 700 may include at least four cap grooves 725. The cap grooves 725 may be equally spaced around the circumference of the inner surface of the side wall 700a. Alternatively, the cap grooves 725 may be arranged with different angular offsets in the circumferential direction.

[0413] In one embodiment, the device body 700 may include at least one holder guide rib 726 (see Figure 7B)。In one embodiment, the device body 700 includes four holder guide ribs 726. The holder guide ribs 726 may extend radially inwardly from the sidewall 700a. The holder guide ribs 726 may extend distally from the proximal end of the device body 700 (e.g., the orifice 730) until approximately half the length of the central support structure 701. For example, the holder guide ribs 726 may extend distally from the proximal end of the device body 700 until the proximal end of the needle shield guide rib 723 and / or until the proximal end of the needle shield radial support rib 722. Alternatively or additionally, the holder guide ribs 726 may extend distally from the proximal end of the device body 700 at least until the proximal end of the needle shield locking anti-disengagement structure 720.1, e.g., until the axial position where the amount of the rib 720.1 extending radially inwardly from the sidewall 700a becomes zero.

[0414] The holder guide ribs 726 may have a triangular cross-section or include a rectangle (e.g., a square) and have a triangular cross-section on their radially inner surfaces, with the tip of the triangle pointing towards the axis of symmetry of the device body 700. The holder guide ribs 726 may be angularly offset from each other by at least 30 degrees, at least 45 degrees, or at least 60 degrees. In other words, the offset of one holder guide rib 726 from its first adjacent holder guide rib may be less than the offset from its second adjacent holder guide rib. In one embodiment, the holder guide ribs 726 may be circumferentially equidistantly arranged.

[0415] In one embodiment, the holder guide ribs 726 may be configured to interact with the syringe holder 800. For example, the holder guide ribs 726 may be configured to interact with the guide features 811 of the syringe holder 800 during and / or after the assembly of the syringe holder 800, as described below. For example, the holder guide ribs 726 may prevent the syringe holder 800 from rotating relative to the device body 700, thereby defining, for example, the spatial orientation of the syringe holder 800 relative to the device body 700 during and / or after assembling the syringe holder 800 to the device body 700.

[0416] Alternatively or additionally, the holder guide ribs 726 may be configured to interact with the drive spring holder 1200 (described below). For example, the holder guide ribs 726 may be configured to interact with the guide rib 1202.1 of the drive spring holder 1200 during and / or after assembling the drive spring holder 1200 to the device body 700, as described in more detail in Section 12 below. For example, the holder guide ribs 726 may prevent the drive spring holder 1200 from rotating relative to the device body 700, thereby defining, for example, the spatial orientation of the drive spring holder 1200 relative to the device body 700 during and / or after assembling the drive spring holder 1200 to the device body 700.

[0417] In one embodiment, the device body 700 may include at least one, preferably at least four cap ribs 727 (see Figure 7F ). The cap ribs 727 may project radially inwards from the inner surface of the side wall 700a. The cap ribs 727 are configured to interact with the cap clip 204. In particular, the cap ribs 727 may prevent the cap clip 204 from moving radially outwards, thereby preventing the cap clip 204 from disengaging from the cap clip window 504 of the needle shield 500. As Fig.12F shown, the device body 700 may include two sets of cap ribs, each set having three cap ribs 727. The two sets may be angularly offset from each other by 180 degrees.

[0418] The cap ribs 727 within each set may be arranged equidistantly in the circumferential direction. Each set of cap ribs 727 may be formed at substantially the same axial position as the needle shield locking element 720, with a 90-degree angular offset therefrom. In other words, each set of cap ribs 727 may be aligned with the needle shield front stop 724 in the circumferential direction. The cap ribs 727 may be arranged distally of the needle shield front stop 724.

[0419] In one embodiment, the device body 700 includes a label on the outer surface of the side wall 700a. The label may be attached to or connected to or directly integrated in the side wall 700a. The label may prevent the injection molding gate recess 712 and / or the cutouts 713, 714 from being visible to the user. This may provide comfort to the user. The label may contain information about the drug delivery device 100, such as information about the drug Dr to be administered with the drug delivery device 100 or the manufacturing date of the drug delivery device 100.

[0420] In one embodiment, the label includes a near field communication (NFC) label. The NFC label may be a passive NFC label, for example configured to direct the user to a website or application. Alternatively or additionally, the NFC label may be an active NFC label that can act as a sensor. For example, the NFC label may be a radio frequency identification (RFID) label.

[0421] 8. Syringe holder ( FIG. 8A to FIG. 8D )

[0422] Fig. 8A and Figure 8B An optional syringe holder 800 is shown to allow accurate support of the pre-filled syringe 900 during and after assembly. In a particular embodiment, the drug delivery device may include a syringe holder 800, such as a container holder. The syringe holder 800 may be adapted to assemble and hold a pre-filled syringe 900 (such as a medicament container) within the device body 700, which will be further explained in more detail below.

[0423] In particular, the syringe 900 can be a 1.0 ml pre-filled syringe 900 with a rigid protective needle shield 914 (RNS). Generally, the size (e.g., length and / or diameter) of the syringe 900 and / or the protective needle shield 914 (also referred to as the "needle shield") may vary. To allow the pre-filled syringe 900 to be accurately supported in the mounting position despite these variations, the design of the syringe holder 800 and the device body 700 (front shell) can be adapted to displace and position the needle shield 914 to a predetermined position during assembly, thereby providing sufficient spacing to support the pre-filled syringe 900 at its reference point in the mounting position. The reference point can be the distal shoulder of the syringe barrel. Alternatively or additionally, the radial diameter of the syringe shoulder can be smaller than the radial diameter of the needle shield (e.g., this is typically the case for a 1 ml syringe), such that the syringe holder facilitates access to the syringe shoulder.

[0424] Thus, the syringe holder 800 can include flexible holder arms 801 that are adapted to engage and / or position the syringe 900 and / or hold it in the mounting position. The flexible holder arms 801 can project inwardly in the relaxed state. Alternatively, the flexible holder arms 801 can project outwardly in the relaxed state. Other configurations of the arms in the relaxed state are possible.

[0425] The syringe holder 800 can include a holder housing 800a (e.g., a body portion) adapted to receive the pre-filled syringe 900 and at least two flexible holder arms 801 (e.g., four flexible holder arms 801) adapted to couple to the pre-filled syringe 900 in the mounting position. The holder housing 800a can be formed as a hollow cylinder or a cylindrical portion.

[0426] The flexible holder arms 801 can extend distally from the axial holder front end 802 (e.g., the distal end 802) of the holder housing 800a and can project inwardly in the relaxed state, e.g., be shaped inwardly, e.g., angled. The flexible holder arms 801 can include holder protrusions 803 at their distal ends, which can point radially (e.g., inwardly).

[0427] The flexible holder arms 801 can have the same width throughout their entire extent, i.e., the width of one flexible holder arm at the syringe holder front end 802 corresponds to the width of that flexible holder arm at its distal end (see Fig. 8A ).

[0428] The holder protrusions 803 can include a ramp on their radially inward-facing surface that increases in height in the proximal direction (best seen in Figure 8B ), which aids in the assembly process as described below in FIG. 14B to FIG. 14E .

[0429] The retainer projection 803 can have the function of keeping the connection between the syringe holder 800 and the pre-filled syringe 900 stable at the installation position of the pre-filled syringe 900 and / or the syringe holder. The retainer projection 813 can be particularly adapted to engage the space between the proximal end of the needle guard 914 and the shoulder of the pre-filled syringe 900.

[0430] To support the final assembly of the pre-filled syringe 900 into the syringe holder 800, at least two flexible retainer arms 801 can be adapted to be coupled to the pre-filled syringe 900 at the installation position in such a way that the outward pre-stressed flexible retainer arms 801 radially inwardly return or snap back, for example to a relaxed state, at the installation position (e.g., between the rigid needle guard 914 and the shoulder 904 of the pre-filled syringe 900). Due to the relative movement of the syringe holder 800 relative to the syringe 900, such as the syringe holder moving distally, the flexible retainer arms 801 can return to the relaxed state. Such relative movement can be caused by an axial force acting on the syringe holder 800 (e.g., on the retainer rear end 804).

[0431] Furthermore, when the syringe 900 is in the installation position, the device body 700 (front shell) can be adapted to restrain the flexible retainer arms 801 from deflecting outwardly. This secures the syringe in the syringe holder.

[0432] The syringe holder 800 can include a retainer rear end 804 opposite to the retainer front end 802, i.e., the proximal end. At the retainer rear end 804, the retainer 800 can include a retainer flange portion 805, which includes a retainer clip 806 for releasably and intermittently holding the syringe holder 800 relative to the device body 700.

[0433] The retainer flange portion 805 can form a receiving space 818 through which the pre-filled syringe 900 is inserted distally into the hollow cylinder formed by the retainer body 800a.

[0434] The retainer flange portion 805 can be non-circular, for example including two rounded sections 813 arranged opposite to each other (e.g., diametrically opposite) of the retainer flange portion 805, and two radially inwardly recessed sections 812 that are flatter than the rounded sections 813. Thus, the two rounded sections extend circumferentially in the form of semi-circles. The two recessed sections can be arranged at the other two opposite (e.g., diametrically opposite) ends of the retainer flange portion 805 and are arranged on opposite sides of the retainer flange portion 805 relative to the rounded sections 813. The two recessed sections 812 can define a recessed outer flange surface.

[0435] Two rounded sections 813 may be circumferentially aligned with the window 814 of the syringe holder 800. This may be because the incision 714, as described with respect to the body 700, may be circumferentially aligned with the drug window 710 of the device body 700. The recessed section 812 may be arranged to be offset 90 degrees circumferentially relative to the window 814 of the syringe holder 800 and may in particular be circumferentially aligned with the rib 807 described in more detail later.

[0436] The axial extension of the recessed section 812 in the proximal direction may be less than the axial extension of the rounded section 813 in the proximal direction, as Figure 8B indicated by the length l2 in. In other words, the proximal end 813a of the rounded section 813 may be closer to the proximal side than the proximal end 812a of the recessed section 812.

[0437] Thus, the two rounded sections 813 that axially extend further outward in the proximal direction may define a receiving space for receiving the syringe flange when the syringe flange of the pre-filled syringe 900 is mounted on the syringe holder 800.

[0438] Once installed, the pre-filled syringe 900 may be rotationally locked relative to the syringe holder 800 and / or relative to the device body 700. Specifically, the rounded section 813 may include ribs 819 on the inner surface, and these ribs may prevent the installed pre-filled syringe 900 from rotating in the assembled state.

[0439] However, in embodiments where such rotation is considered necessary or advantageous, the pre-filled syringe 900 may also be rotated relative to the syringe holder 800 and / or the device body 700.

[0440] The two recessed sections 812 may be recesses 812 that axially extend throughout the holder flange portion 805 in the holder flange portion 805. The edge between the rounded section 813 of the holder flange portion 805 and the flat recess of the holder flange portion 805 may further include or form a guiding feature 811 to assist in positioning the syringe holder 800 into the body during assembly. In other words, the syringe holder 800 may include a guiding feature 811 that extends along the longitudinal axis on the holder flange portion 805, and the guiding feature 811 is arranged on the side wall of the holder flange portion 805, thereby defining the space defined by the recessed section 812.

[0441] The flat recessed section may form a receiving space for the needle shield arm, for example, during assembly or in the device.

[0442] Each recess may further include at least one, for example two, ramp-shaped protrusions 810, the height of which increases towards the rear end 804 (e.g., proximal end 804) of the syringe holder. The ramp-shaped protrusions 810 may serve as guiding features for the needle shield arm during the assembly step of inserting the prefilled syringe 900 and the syringe holder 800 into the device body 700.

[0443] The ramp-shaped protrusions 810 may be arranged proximally on the recessed section 812 such that the proximal ends of the ramp-shaped protrusions 810 are substantially in a plane with the proximal end 812a of the recessed section 812.

[0444] Two ramp-shaped protrusions 810 may be angularly arranged at opposite ends of the outer convex surface of the recess. In the case of two ramp-shaped protrusions, the two ramp-shaped protrusions may define a channel centrally arranged between the two ramp-shaped protrusions, which is configured to allow a rib of a part of the needle shield to pass through during the assembly of the drug delivery device and / or at the installation position of the container holder.

[0445] The recessed section 812 may be radially defined by the surface of the holder flange portion 805. The holder flange portion 805 may be a rounded section 813 of the proximal region of the holder body. The recessed section 812 may define a space angularly defined by the side walls of the holder flange portion 805, wherein the distal and proximal ends of the recessed section 812 may be open.

[0446] The space defined by the recessed section 812 may be adapted to engage and / or receive a part of the needle shield of the drug delivery device at the installation position of the container holder 800. The inward radial depth of the space defined by the recessed section 812 decreases in the proximal direction. This is particularly useful when assembling the drug delivery device 100 as it deflects the needle shield side region (e.g., legs) as needed during the assembly of the drug delivery device. The inward radial depth of the space defined by the recessed section 812 is constant.

[0447] The retaining clip 806 may be integrally formed on the holder flange portion 805 as a tongue or clip. In particular, the retaining clip 806 may have a flexible portion that extends substantially in the axial direction and is deflectable in the radial direction. The retaining clip 806 may be arranged on the rounded section 813 of the holder flange portion 805. The retaining clips 806 may be circumferentially offset relative to the midpoint of the respective rounded section 813 on which they are arranged. The retaining clips 806 may be on opposite circumferential sides of each other.

[0448] The holding clip 806, particularly its flexible portion, can further extend axially from the distal end of the holder flange portion 805 towards the proximal end of the holder flange portion 805. The holding clip 806 can be configured not to extend over the axial elongation of the holder flange portion 805. In particular, the extension length of the holding clip 806 in the proximal direction can be the same as the length of the retracted portion (such as the recessed portion 812).

[0449] In other words, the extension amount of the holding clip 806 towards the proximal side can be less than the extension amount of the holder flange portion 805.

[0450] The proximal end of the holding clip 806 can point radially outwards to engage with the notches 713, 714 of the device body 700. In one embodiment, the proximal end can have an inclined surface that is radially outwardly inclined along the proximal direction P. In an embodiment, the syringe holder 800 can include two holding clips 806 arranged opposite to each other. Instead of the notches, the device body 700 can include an inner support member to releasably hold these holding clips 806. In particular, the inner support member can be formed as an inner groove.

[0451] The holding clip 806 is configured such that in the first engagement position of the syringe holder, the holding clip 806 interacts with a groove (such as the proximal notch 714 of the device body 700). In the first engagement position, the syringe holder 800 can be moved distally, but its proximal movement relative to the device body 700 can be prevented, thereby preventing it from disengaging from the device body 700. For example, this can be achieved, for example, by the distal ramp surface of the holding clip 806 (such as a ramp with an increasing height along its proximal direction). Further, in the first engagement position, the rotation of the syringe holder 800 relative to the device body 700 can be prevented.

[0452] The holding clip 806 is configured such that when the syringe holder 800 is moved distally, such as during its assembly, the holding clip 806 disengages from the notch 714. Further distal movement of the syringe holder 800 radially inwardly biases the holding clip 806 again until the holding clip 806 aligns with the distal groove (such as the distal notch 713 of the device body 700). When aligned, the holding clip 806 interacts with the notch 713 by deflecting radially outwards into the space formed by the notch 713. This is the second engagement position of the syringe holder 800. The interaction between the holding clip 806 and the notch 713 prevents the syringe holder 800 from moving proximally and rotating relative to the device body 700.

[0453] At least one optional longitudinal rib 807 may be arranged on the holder housing 800a, for example, two ribs on opposite sides of each other. The longitudinal rib 807 may be used to axially position the syringe holder 800 relative to the device body 700. The longitudinal rib 807 may include a stop feature 809 that is positioned at one end of the longitudinal rib 807 facing the front end 802 of the holder. The stop feature 809 is configured to abut a corresponding element of the device body, as shown and described with respect to Fig. 7E . This may limit the distal movement of the syringe holder relative to the device body. The stop feature may be wider than the longitudinal rib 807.

[0454] In addition, the holder housing 800a may include at least one elongated holder window 808 to enable visual inspection of the amount of drug Dr in the prefilled syringe 900 when the syringe 900 is installed within the syringe holder 800. The holder housing 800a may include two elongated holder windows 808 on opposite sides of each other.

[0455] The holder window 808 may be configured to be larger in size than the drug window 710 of the body 700, so as to reduce the visibility of the holder housing 800a when viewed through the drug window 710 of the body 700, for example, to hide the holder housing. This increases the confidence of the user (e.g., the patient) because they do not have to face any internal parts of the drug delivery device and enables them to unobstructedly view the prefilled syringe 900 through the holder window 808 and the drug window 710 of the body 700.

[0456] The inner surface of the holder housing 800a may further include longitudinal ribs, such as support ribs 814 that extend substantially along the inner surface of the holder housing 800a. The support ribs 814 may extend further proximally than the holder housing 800a, and thus extend onto the inner surface of the recessed section 812.

[0457] Once the prefilled syringe 900 is inserted into the syringe holder 800, the support ribs 804 may provide support for the syringe barrel 902. The support ribs 814 further have the following function: once the prefilled syringe 900 is inserted into the syringe holder 800, it centers the prefilled syringe 900, thereby ensuring that the prefilled syringe 900 is centered inside the holder body 800a. By centering the prefilled syringe 900 with the support ribs 804, the needle of the prefilled syringe 900 is axially parallel to the axial extension amount of the drug delivery device, and preferably centered relative to the circumference defined by the body of the drug delivery device. This ensures a more precise injection process.

[0458] Fig.7DShows the syringe holder 800 disposed within the device body 700. The length of the generally cylindrical central syringe support 701 may be less than half the length of the barrel 902 of the syringe 900 or less than a quarter of the length of the barrel 902 of the syringe 900, for example to save plastic material. Thus, within the central syringe support 701, an elongated window may not be necessary and may not be present.

[0459] The outer diameter of the needle shield 914 may be substantially equal to the outer diameter of the barrel 902 of the syringe 900. Thus, the distal end of the flexible holder arm 801, such as the holder protrusion 803 extending radially inwards, may be disposed between the shoulder 904 and the proximal end of the needle shield 914. Thereby, the needle shield 914 may be moved a short distance in the distal direction D. However, the sterility of the needle 908 can still be ensured thereby. The cap 200 and the needle shield 914 can be easily removed by providing a gap between the proximal end of the needle shield 914 and the shoulder 904. In other embodiments, the needle shield may not move.

[0460] As Figure 3A and Fig. 7A As shown in, to further facilitate user manipulation, especially when removing the cap 200, the device body 700 includes on its outer surface an on-body user indicator 733. The on-body user indicator 733 may be a gripping surface. Preferably, the device body 700 has two on-body user indicators 733 arranged opposite each other. The on-body user indicator 733 is in the shape of three rectangles located on the distal end of the device body 700, the area sizes of these three rectangles increasing in the distal direction D, and these rectangles being adjacent to each other in the axial direction A. The on-cap user indicator 203 (as described in Section 3 above) and the on-body user indicator 733 may form a user indicator. Thus, the on-body user indicator 733 indicates to the user in which direction the cap must be pulled when removing the cap 200 from the drug delivery device 100. Since the rectangles are formed as recesses in the device body 700, the rectangles also support a firm grip by the user when gripping the device 100. Thus, the on-body user indicator 733 provides both visual and tactile assistance to the user. The on-body user indicator 733 is located distally relative to the drug window along the longitudinal axis of the device body 700. The on-body user indicator 733 may have three rectangular recesses. The lengths of the side edges of the rectangles extending transversely to the longitudinal axis may be the same, and the lengths of the side edges of the rectangles extending along the longitudinal axis may increase in the distal direction. In addition, the recess disposed most distally of the on-body user indicator 733 may be located directly adjacent to the opening of the device body. The on-cap user indicator 203 may have two recesses, wherein the first recess is arrow-shaped and the second recess is rectangular or trapezoidal in shape. The recess with the arrow may be located distally relative to the recess with the trapezoidal or rectangular shape.

[0461] Figure 8C Shows an exemplary embodiment of a possible alternative or additional shape of at least one flexible holder arm 801 of the syringe holder 800.

[0462] In this embodiment, the flexible holder arm 801 may include a distal portion 816 that is configured to be wider in width than a proximal portion 817 of the flexible holder arm 801.

[0463] Figure 8C The distal portion 816 of the flexible arm 801 is wider than Fig. 8A The distal portion 816 of the flexible holder arm 801 of Figure 14K . In other words, when viewed circumferentially, the width of the flexible arm decreases proximally. By having a wider distal portion 816, the holder protrusion 803 that points radially inward and is disposed at the distal end of the flexible holder arm 801 is also wider, thereby increasing the contact surface of the holder protrusion with the pre-filled syringe 900 (e.g., with the barrel 902 of the pre-filled syringe 900) (see, for example, FIGS. 14a to

[0464] ).

[0465] Fig.8D Shows another exemplary embodiment of the syringe holder 800, where Figure 8C The flexible holder arms 801 of Fig.8D The other features of the syringe holder 800 of Fig. 8A and Figure 8B The features in the syringe holder 800 of

[0466] 9. Pre-filled syringe ( Fig. 9 )

[0467] Fig. 9Shows an optional pre-filled syringe 900. In particular, the syringe 900 can be a 1.0 ml pre-filled syringe 900, where the RNS 914 or SNS 914 covers the hollow needle 908. Other volumes of the drug Dr are also possible. Generally, the dimensions (e.g., length and / or diameter) of the pre-filled syringe 900 and the needle shield 914 may vary. The needle shield 914 can be configured to cover the needle 908 and a portion of the cone 906 at the front end (e.g., the distal end) of the pre-filled syringe 900. The needle shield 914 can be further configured such that in the installed position, there is a space between the proximal end of the needle shield 914 and the shoulder 904 of the pre-filled syringe 900. The pre-filled syringe 900 can further include a syringe flange 912 at its proximal end.

[0468] The pre-filled syringe 900 further includes a barrel 902 that contains the drug Dr, particularly, for example, a medicament M to be injected into a patient or user.

[0469] Before the start of the injection, the needle shield 914 must be removed to expose the needle 908. This can be achieved by removing the cap 200 of the drug delivery device 100 together with the gripper 400, as described above with respect to the gripper 400 and the cap 200. During the injection, the plunger stopper 910 inserted into the barrel 902 can be pushed towards the distal end of the barrel 902 (e.g., towards the needle 908) to push the drug Dr (e.g., the medicament M) towards the distal end of the pre-filled syringe 900 and out of the needle 908 and into the injection area. The plunger stopper 910 can be configured to prevent the drug Dr from leaving the barrel 902 in the proximal direction, but can slide along the barrel 902 when a force acts on it in the distal direction (e.g., towards the needle 908).

[0470] Examples of the pre-filled syringe 900 are the Neopak 1 ml long pre-filled syringe (with a special thin-walled needle of size 27) from Becton Dickinson (BD) and the Ompi EZ-Fill 1 ml long pre-filled syringe (with a thin-walled needle of size 27). Both syringes include RNS and West 2340 Flurotec plunger stoppers. Other syringes or other medicament containers can also be used, especially those including different volumes of the drug Dr and / or different needle diameters, especially the outer diameter.

[0471] According to at least one embodiment, the range of the dose volume can be between 0.5 milliliters (ml) and 1.14 ml, and the viscosity of the drug is between 1 centipoise (cP) and 25 cP.

[0472] Additional examples of prefilled syringes can be the Neopak 2ml long prefilled syringe (with a special thin-walled needle of size 27G) and the Ompi EZ-Fill 2ml long prefilled syringe (with a thin-walled needle of size 27G) from Becton Dickinson (BD), both having a rigid needle shield (RNS) and a West 2340 Flurotec plunger stop.

[0473] According to at least one embodiment, the dose volume can range between 1.15 ml and 2.25 ml, and the viscosity of the drug can range between 1 cP and 25 cP.

[0474] 10. Plunger ( Figures 10 to 10M )

[0475] Fig.10 The plunger 1000 is shown. The plunger 1000 can include an elongated, preferably cylindrical plunger shaft 1010. The plunger shaft 1010 can be hollow, for example, to provide assembly space for the drive spring 1100 and the optional spring support arm / pin 1230. On the inner surface, the plunger shaft 1010 can have at least one longitudinal rib 1060.1 to 1060.4 for guiding the drive spring 1100. The distal portion D of the plunger 1000 can be closed, for example, by a cylindrical end portion having a diameter smaller than that of the plunger shaft 1010, for example, to dock with a complementary or substantially complementary recess in the plunger stop 910.

[0476] The proximal end of the plunger 1000 can include a number of radially protruding portions, for example, at least two or at least three protruding portions or two sets each including at least two or at least three protruding portions:

[0477] - A first plunger boss 1040.1, which is configured to interact with the profiled groove 1221.1 of the drive spring holder 1200 (described in section 12), see, for example, FIG. 10A to FIG. 10F and Fig.10I ,

[0478] - A second plunger boss 1040.2, which is configured to interact with the plunger boss groove 506 of the needle shield 500, see, for example, Figure 10G and Fig. 10H , and

[0479] - An angled plunger rib 1040.3.

[0480] In the following description of Fig.10I the purpose of the distal edge (face) 1040.1d of the first plunger boss 1040.1 is described in more detail. In the following description of Fig.12DThe purpose of the proximal (face) 1040.9 of the first plunger boss 1040.1 is described in more detail in the description.

[0481] Furthermore, optional plunger grooves 1020, 1022, etc. may be provided at the proximal end P of the plunger 1010. Irrespective of the length of the plunger 1000, the grooves 1020, 1022 can be used to provide triggering of the rattle 1300, either directly or indirectly via a flexible arm that supports the rattle 1300 in its biased state and has protrusions adapted to fit into the grooves 1020, 1022. There may be at least one plunger groove 1020 or at least two plunger grooves 1020, 1022, such as a pair of plunger grooves, adapted to be coupled to at least one protrusion or a pair of protrusions of a flexible arm that supports the rattle 1300. Optionally, at least one additional groove may be on the underside of the plunger 1000, for example in order to provide a symmetric design and ease of assembly of the plunger 1000.

[0482] Fig. 10A The plunger release mechanism 1025 in a first state is shown. The following elements of the drive spring holder 1200 may be relevant:

[0483] - the proximal region 1221,

[0484] - the profiled groove 1221.1,

[0485] - the first angled surface 1221.2 of the profiled groove 1221.1,

[0486] - the wall 1221.3 of the profiled groove 1221.1, which may extend substantially in the axial direction of the drug delivery device 100 and may be arranged between the first angled surface 1221.2 and the second angled surface 1221.4,

[0487] - the second angled surface 1221.4 of the profiled groove 1221.1, and

[0488] - the longitudinal edge 1234 of the profiled groove 1221.1 (also see Fig. 12A and Fig. 12B ), which may be radially positioned in a region that does not interact with the first plunger boss 1040.1.

[0489] The plunger release mechanism 1025 may include a first plunger lug 1040.1 disposed on the plunger 1000 and an irregular groove 1221.1 in the proximal region 1221 (rear portion of the device body 700) of the drive spring holder 1200. The irregular groove 1221.1 may include: a first angled surface 1221.2 adapted to engage with the first plunger lug 1040.1 to apply a torque to the plunger 1000 in a first rotational direction R1; a wall 1221.3 for restricting the movement of the first plunger lug 1040.1 in the first rotational direction R1 when engaged with the first angled surface 1221.2. Additionally, the irregular groove 1221.1 may include a second angled surface 1221.4 adapted to engage with the first plunger lug 1040.1 to apply a torque to the plunger 1000 in the first rotational direction R1.

[0490] The inclination angle of the first angled surface 1221.2 and / or the second angled surface 1221.4 with respect to a perpendicular line to the longitudinal axis A of the drug delivery device 100 (which may also be the longitudinal axis of the plunger 1000) may be in the range of 30° to 70°. In other words, the inclination angle of the first angled surface 1221.2 with respect to the circumferential direction may be in the range of 30° to 70°.

[0491] In Fig. 10A the first state shown, the first plunger lug 1040.1 is engaged with the first angled surface 1221.2. Due to the drive spring 1100 acting on the plunger 1000, the first plunger lug 1040.1 presses against the first angled surface 1221.2 in the distal direction D, such that a torque is applied to the plunger 1000 in the first rotational direction R1, causing the first plunger lug 1040.1 to slide along the first angled surface 1221.2 until it abuts against the wall 1221.3, thereby stopping the rotation of the plunger 1000 in the first rotational direction R1. The first state may be used for assembling the drive sub-assembly.

[0492] Optionally, a recess 1221.15 may be disposed on the proximal side surface of the irregular groove 1221.1, which, as described below, may serve as a drop protection and / or as a guiding feature for guiding the first plunger lug (rib) 1040.1 in a rotational direction opposite to the rotational direction R1.

[0493] Fig. 10BThe plunger release mechanism 1025 in the second state is shown. Starting from the first state, the plunger 1000 has moved in the proximal direction P a distance at least as long as the wall 1221.3, such that the wall 1221.3 no longer restricts the movement of the first plunger lug 1040.1 in the first rotational direction R1. The plunger 1000 has then rotated further in the first rotational direction R1 such that the first plunger lug 1040.1 engages, for example by using the needle shield 500, with the second angled surface 1221.4. Due to the drive spring 1100 acting on the plunger 1000, the first plunger lug 1040.1 presses against the second angled surface 1221.4 in the distal direction D, such that a torque is applied to the plunger 1000 in the first rotational direction R1, causing the first plunger lug 1040.1 to slide along the second angled surface 1221.4. If the plunger 1000 is not otherwise prevented from further rotating, the first plunger lug 1040.1 can slide down along the second angled surface 1221.4 until disengaging therefrom, thereby allowing the plunger 1000 to advance in the distal direction D to displace the drug Dr or medicament M from the pre-filled syringe 900. However, this will only occur later, i.e., when triggering the drug delivery device 100 by pressing it, for example using the needle shield 500, against the user's skin.

[0494] In an exemplary embodiment, the movement of the plunger 1000 from the first state to the second angled surface 1221.4 can be achieved by the interaction of the needle shield 500 (proximal sleeve portion 513) with the plunger 1000, for example by engaging with a plunger lug or rib on the plunger 1000. This can be done during final assembly, i.e., during the assembly of the control subassembly and the drive subassembly. Additionally, again, this can be different from triggering the drug delivery of the device 100.

[0495] Alternatively, other parts of the drug delivery device 100 can be used for this purpose. For example, the end plate of the drive spring holder 1200 includes appropriate protrusions, whereby the shape of the first angled surface 1221.2 can be different, for example angled in the opposite direction compared to the FIG. 10A to FIG. 10F direction shown and without using the wall 1221.3. In this alternative embodiment, the plunger rib / protrusion 1040.3 can be omitted or absent.

[0496] An exemplary embodiment of the plunger release mechanism 1025 is shown in Fig. 10C 、 Fig. 10D 、 Fig.10E and Fig.10F in more detail. Fig. 10C The plunger release mechanism 1025 during the final assembly of the control subassembly and the drive subassembly is shown. The needle shield 500 includes a proximal sleeve portion 513. The proximal sleeve portion 513 can include:

[0497] - A groove rib 507 (such as an angled groove rib 507), including a longitudinally extending portion (such as the groove rib 507, see Figure 5 ), and a circumferentially extending portion (such as the second ramp 507d, see Figure 5 ):

[0498] - A proximal surface 513.2, such as on the circumferentially extending portion (the second ramp 507d),

[0499] - A distal surface 513.3, such as on the circumferentially extending portion (the second ramp 507d),

[0500] - An abutment surface 507b, such as on the longitudinally extending portion, such as on the groove rib 507, and

[0501] - An optional first ramp 507c, see Fig. 10H .

[0502] The proximal sleeve portion 513 may include a plunger boss groove 506, see Figure 10G and Figure 10H . The plunger boss groove 506 is described in more detail in Section 5 above, and includes, for example, a proximal groove 506a and a distal groove 506b.

[0503] There may be a pair of proximal sleeve portions 513 that each interact with a set of plunger protrusions 1040.2 and / or 1040.3, for example in order to apply a symmetrical force on the protrusions 1040.2 and / or 1040.3 and other parts, thereby preventing parts from jamming and enabling the drug delivery device 100 to operate smoothly.

[0504] The plunger release mechanism 1025 may essentially have two functions:

[0505] a) During the assembly of the control subassembly and the drive subassembly, move the plunger 1000 from its first state to its second state, that is, the needle shield 500 is stationary relative to the device body 700, but the device body 700 including the needle shield 500 moves axially relative to the drive spring holder 1200, and vice versa, see Figure 10C and Figure 10D . As described above, the needle shield 500 or other parts may be used for this purpose, such as other parts of the device 100.

[0506] b) If the needle shield 500 is pressed against the patient's skin, that is, during the relative movement of the needle shield 500 relative to the device body 700 (the front part of the housing) and relative to the drive spring holder 1200 (the rear part of the housing), then release the plunger 1000, see Figure 10F .

[0507] The plunger release mechanism 1025 may include a plunger 1000, a proximal region 1021, and a proximal sleeve portion 513 that interact with each other. The proximal sleeve portion 513 and the proximal region 1221 are configured to move axially only relative to each other, e.g., move relative to each other parallel to or along a longitudinal axis A, while the plunger 1000 may move parallel to the longitudinal axis A and rotate about the longitudinal axis A, see the rotational directions R1 and R2. These parts of the plunger release mechanism 1025 may be substantially rigid and do not need to deform to function properly.

[0508] The parts arranged for engaging with the plunger 1000, the proximal region 1221, and the proximal sleeve portion 513 may include:

[0509] - A first plunger boss 1040.1 on the plunger 1000,

[0510] - A second plunger boss 1040.2 on the plunger 1000,

[0511] - An angled plunger rib 1040.3 on the plunger 1000,

[0512] - A profiled groove 1221.1 in the proximal region 1221, which is adapted to interact with the first plunger boss 1040.1,

[0513] - A groove rib 507 on the proximal sleeve portion 513, a proximal surface 513.2 of the plunger boss groove 506 adapted to interact with the angled plunger rib 1040.3, a distal surface 513.3 of the plunger boss groove 506, and an abutment surface 507b of the plunger boss groove 506 adapted to interact with the second plunger boss 1040.2.

[0514] In Figure 10C a clearance 1030 is shown, which clearly indicates that there may be a rotational offset between two parts of the figure. However, the three protrusions of the plunger 1000 may have fixed positions relative to each other, see the dashed line 1032.

[0515] The profiled groove 1221.1 may include: a first angled surface 1221.2, which is adapted to engage with the first plunger boss 1040.1 to apply a torque to the plunger 1000 in the first rotational direction R1; a wall 1221.3 for restricting the movement of the first plunger boss 1040.1 in the first rotational direction R1 when engaging with the first angled surface 1221.2. In addition, the profiled groove 1221.1 may include a second angled surface 1221.4, which is adapted to engage with the first plunger boss 1040.1 to apply a torque to the plunger 1000 in the first rotational direction R1.

[0516] As described above, during the assembly of the drive sub-assembly, the plunger 1000 and the drive spring 1100 are inserted into the proximal region 1221. Once the plunger 1000 reaches the proximal position, the first plunger lug 1040.1 is axially aligned with the profiled groove 1221.1. By rotating the plunger 1000 by a certain angle (e.g., approximately 30°) in the second rotational direction R2, the first plunger lug 1040.1 moves into the profiled groove 1221.1. In this position, since the drive spring 1100 biases the plunger 1000 in the distal direction D, the first angled surface 1221.2 causes the first plunger lug 1040.1 to move against the wall 1221.3 by applying a torque in the first rotational direction R1 to the plunger 1000.

[0517] For the final assembly of the drug delivery device 100, the syringe barrel 900 can be inserted into the control sub-assembly, which can include the device body 700 (the front part of the housing).

[0518] Thereafter, the drive sub-assembly is inserted into the control sub-assembly in the distal direction D. The proximal region 1221 and the device body 700 can include snap connections to lock them together during assembly. During the final assembly of the drug delivery device 100, the needle shield 500 together with the proximal sleeve portion 513 can be partially pressed in to allow, for example, the plunger release mechanism 1025 to be activated from the first state to the second state by an assembly jig (not shown) or in a different way. The activation of the plunger release mechanism 1025 is different from triggering.

[0519] Figure 10D The plunger release mechanism 1025 during the final assembly is shown. Exemplarily, the groove rib 507, especially the proximal surface 513.2, abuts the angled plunger rib 1040.3 proximally, thereby applying a torque in the first rotational direction R1 to the plunger 1000 and pushing the plunger 1000 in the proximal direction P, such that the first plunger lug 1040.1 moves along the wall 1221.3 until it disengages from the wall 1221.3. This action is the start-up of the device. Due to the applied torque, the first plunger lug 1040.1 moves in the first rotational direction R1 and engages with the second angled surface 1221.4. The pressing-in of the needle shield 500 together with the proximal sleeve portion 513 can be stopped, and since the first plunger lug 1040.1 engages with the second angled surface 1221.4 and the drive spring 1100 acts on the plunger 1000 in the distal direction D, the plunger 1000 can rotate further in the first rotational direction R1.

[0520] Since the needle shield 500 and thus the proximal sleeve portion 513 are no longer being further pressed in, the needle shield can move in the distal direction D relative to the device body 700, for example under the action of a needle shield spring 600 (sleeve spring, not shown). This movement can be restricted by the second plunger lug 1040.2 abutting against the distal face 513.3 on the groove rib 507. Further rotation of the plunger 1000 in the first rotational direction R1 can be prevented by the second plunger lug 1040.2 abutting against the longitudinal face of the groove rib 507. By engaging the first plunger lug 1040.1 with the profiled groove 1221.1, the load of the drive spring 1100 can be decomposed within the proximal region 1221. This state (i.e., the second state) of the plunger release mechanism 1025 is shown in Figure 10E in.

[0521] The operating sequence of the drug delivery device 100 can be as follows:

[0522] The user removes the cap 200 and the cap cover 300 by pulling the cap 200 and the cap cover 300 away from the device body 700 in the distal direction D. Removing the cap 200 and the cap cover 300 can simultaneously remove the protective needle shield 914 (e.g., a rigid needle shield or a soft needle shield) from the needle 908.

[0523] The needle shield 500 can be in the extended position protruding from the device body 700 in the distal direction D. The extended position can be defined by the second plunger lug 1040.2 abutting proximally against the distal face 513.3 of the groove rib 507.

[0524] Then, the user can press the needle shield 500 of the drug delivery device 100 against the injection site (e.g., the patient's skin) in the forward direction, thereby overcoming the bias of the needle shield spring 600 and causing the needle shield 500 to move from the extended position towards the retracted position.

[0525] Figure 10F is a schematic view of the plunger release mechanism 1025 after the needle shield 500 has been pressed into the retracted position. When the needle shield 500 is moving from the extended position towards the retracted position, the second plunger lug 1040.2 moves in the distal direction D relative to the needle shield 500 (starting from the position shown in Figure 10E and is guided along the abutment surface 507b of the groove rib 507.

[0526] In an exemplary embodiment, the abutment surface 507b of the groove rib 507 can include interruption or raised features (not shown) to increase the force required to further press in the needle shield 500. This can be used to indicate to the user that needle insertion will start with further pressing in of the needle shield 500 together with the proximal sleeve portion 513. Prior to this, the user can freely remove the drug delivery device 100 from the injection site and reposition it, since the needle shield 500 will re-extend to its initial position under the force of the needle shield spring 600.

[0527] If the user continues to press the drug delivery device 100 against the injection site, the needle shield 500 moves to the retracted position, thereby exposing the needle 908 and inserting it into the injection site.

[0528] Once the needle shield 500 has been pressed into the retracted position and the needle 908 inserted, the second plunger boss 1040.2 has moved distally beyond the groove rib 507 such that the rotation of the plunger 1000 in the first rotational direction R1 due to the drive spring 1100 and the torque applied by the engagement of the first plunger boss 1040.1 with the second angled surface 1221.4 on the profiled groove 1221.1 is no longer blocked. The plunger 1000 rotates in the first rotational direction R1 due to this torque, and the first plunger boss 1040.1 leaves the profiled groove 1221.1 and is guided along the internal longitudinal rib 1236, see Figure 10I ... Accordingly, the plunger 1000 is released and advances the plunger stop 910 in the distal direction D, thereby displacing the drug Dr or medicament M from the syringe barrel 900 through the needle 908. The release of the first plunger boss 1040.1 or the second plunger boss 1040.2 may provide an audible feedback that the medicament delivery has started.

[0529] Figure 10G is a schematic detailed view of the plunger release mechanism 1025 after final assembly and before pressing in the needle shield 500 together with the proximal sleeve portion 513 (i.e., with the plunger 1000 in the second state). Figure 10G is a view of the inner side of the proximal portion of the elongate arm of the needle shield 500, in particular of the inner side of the proximal sleeve portion 513. The movement of the needle shield 500 relative to the device body 700 in the distal direction D can be limited by the second plunger boss 1040.2 abutting the distal face 513.3 on the groove rib 507. Further rotation of the plunger 1000 in the first rotational direction R1 can be blocked by the second plunger boss 1040.2 abutting the abutment surface 507b of the groove rib 507.

[0530] Figure 10H is a schematic detailed view of the plunger release mechanism 1025 during the pressing in of the needle shield 500 together with the proximal sleeve portion 513. Figure 10H is a view of the inner side of the proximal portion of the elongate arm of the needle cannula 500, in particular of the inner side of the proximal sleeve portion 513. When the proximal sleeve portion 513 is moving from the extended position in the proximal direction P towards the retracted position, the second plunger boss 1040.2 moves in the distal direction D relative to the needle shield 500 (starting from the position shown in Figure 9 ... ) and is guided along the abutment surface 507b of the groove rib 507.

[0531] If the user continues to press the drug delivery device 100 against the injection site, the needle shield 500 moves to the retracted position, thereby exposing the needle 908 and inserting it into the injection site.

[0532] Once the needle shield 500 is pressed into the retracted position and the needle 908 is inserted, the second plunger boss 1040.2 has moved distally beyond the groove rib 507, so that the plunger 1000 is no longer prevented from rotating in the first rotational direction R1 due to the torque applied by the drive spring 1100 and the first plunger boss 1040.1 engaging the second angled surface 1221.4 on the profiled groove 1221.1. The plunger 1000 rotates in the first rotational direction R1 due to the torque, and the first plunger boss 1040.1 leaves the profiled groove 1221.1. Therefore, the plunger 1000 is released and the plunger stopper 910 is advanced in the distal direction D, thereby displacing the drug / medicament Dr / M from the syringe 900 through the needle 908.

[0533] In addition to the above embodiments, in another embodiment of the plunger release mechanism 1025, a first ramp 507c is provided on the proximal sleeve portion 513. When the proximal sleeve portion 513 approaches the retracted position, the first ramp 507c engages with a rib or boss (e.g., an angled plunger rib 1040.3) on the plunger 1000 to actively rotate the plunger 1000 in the first rotational direction R1. If the plunger 1000 cannot rotate spontaneously due to the features of the aforementioned embodiments, the additional first ramp 507c will rotate the plunger 1000.

[0534] During normal use, the plunger 1000 will release as in the previous embodiment. The first ramp 507c is positioned to interact with the angled plunger rib 1040.3 only when the plunger 1000 does not rotate spontaneously when the needle shield 500 is pressed in together with the proximal sleeve portion 513. It should be easily understood by the skilled person that if only one of the ribs or bosses (e.g., the angled plunger rib 1040.3) or the first ramp 507c on the plunger 1000 is ramped or angled, the embodiment will also work the same. The same applies to the proximal side 513.3.

[0535] Another benefit of another embodiment, namely the use of the first ramp 507c, is that it provides additional guidance for the movement of the plunger 1000 when it is activated.

[0536] In another exemplary embodiment, the engagement of the first ramp 507c with a rib or a boss on the plunger 1000 (such as the angled plunger rib 1040.3) can be the only way to rotate the plunger 1000 out of engagement with the shaped groove 1221.1. For example, the shaped groove 1221.1 may not have an angled surface that causes the plunger 1000 to rotate in the first rotational direction R1 out of engagement with the shaped groove 1221.1. In an exemplary embodiment, the shaped groove 1221.1 may only have a lateral surface that faces in the distal direction D and is laterally oriented with respect to the longitudinal axis A. The lateral surface may have a pawl or a ridge. In another exemplary embodiment, the shaped groove 1221.1 may only have an angled surface that causes the plunger to rotate in the second rotational direction R2 so as to maintain the engagement of the first plunger boss 1040.1 within the shaped groove 1221.1.

[0537] In an exemplary embodiment, the drug delivery device 100 can be an autoinjector.

[0538] Figure 10I An internal longitudinal rib 1236 is shown, which is arranged at the inner side of at least one syringe support arm 1202 of the drive spring holder 1200 (see also Figure 12A and Figure 12B ). In other words, the internal longitudinal rib 1236 can be arranged at the radially inward-facing surface of the arm 1202 of the drive spring holder 1200. In the second state of the plunger 1000, the distal edge / surface 1040.1.d of the first plunger boss 1040.1 abuts the proximal surface 1239 of the sliding surface 1238 on the longitudinal rib 1236. For example, the rib 1236 can have a holding function for holding the plunger 1000 against the biasing force of the drive spring 1100. The proximal surface 1239 can be inclined such that the plunger 1000 rotates further without additional support. However, the second plunger bosses 1040.2, 1040.2a, and 1040.2b are supported on the rib 507a, thus preventing the further rotation of the plunger 1000 as long as the drug delivery device 100 is not fired. If the plunger release mechanism 1025 is triggered to perform an injection by moving the needle shield 500 proximally relative to the device body 700 and relative to the drive spring holder 1200, the rotation of the plunger 1000 is allowed, that is, the second plunger boss 1040.2 rotates freely in the direction R1, see Figure 10H , and the first plunger boss 1040.1 can slide distally via the sliding surface 1238. Guide ribs can be used to guide the further distal movement of the plunger 1000, for example by guiding the first plunger boss 1040.1.

[0539] Thus, the longitudinal edge 1234 does not interfere with the first plunger boss 1040.1. In other words, the longitudinal edge 1234 can be arranged at a position more outward in the radial direction than the inner edges of the first angled surface 1221.2 and the second angled surface 1221.4 and the position of the first plunger boss 1040.1, such that the plunger boss 1040.1 does not contact the longitudinal edge 1234.

[0540] Figure 10J Fig. shows a perspective view of a plunger 1000 according to a second embodiment. The plunger 1000 can be used to expel a drug Dr, M from a drug container 900. The plunger 1000 can include an elongate shaft 1010, such as an elongate plunger rod 1010, which forms, for example, the body of the plunger and extends in a direction from the proximal end 1011p of the plunger 1000 towards the distal end 1011d of the plunger 1000. The distal end 1011d can be configured to transmit a force during the expulsion of the drug Dr, M.

[0541] Optionally, at least one trigger feature TF can be arranged within or on the shaft 1010. The trigger feature TF can be configured to allow the release of the plunger 1000 from other parts of the drug delivery device 100 in order to initiate the expulsion of the drug Dr, M from the drug container 900 (such as a pre-filled syringe 900). In a second embodiment of the plunger 1000, two pairs of plunger ribs 1042a, 1042b can be used as the trigger feature TF, for example, as in Figure 10 the first embodiment shown. At least one common rib CR can be used as a basis for arranging the two pairs of plunger ribs 1042a, 1042b on the plunger 1000 (such as on the plunger shaft 1010). However, optionally, further radially extending ribs 1046 to 1049 and / or support ribs SR including, for example, rounded support features RF can be used to enhance the trigger feature TF, as described in more detail below.

[0542] Optionally, the plunger 1000 can include at least one interaction feature IF, which is configured to interact with a drive source that generates a force for expelling the drug Dr, M. In the second embodiment, a drive spring 1100 can also be used as the driving force. The interaction feature IF can include an internal elongate cavity 1059 within the plunger 1000, more specifically within the shaft 1010. In addition, the interaction feature IF can include internal longitudinal ribs 1060.1 to 1060.4, bevels 1075, and other optional features, as described in more detail below, see Figure 10L and Figure 10M and the corresponding description.

[0543] Additionally or alternatively, the plunger 1000 may include at least one auxiliary structure AS or at least one group 1050a, 1050b including at least two auxiliary structures AS. The at least one auxiliary structure AS or the groups 1050a, 1050b including at least two auxiliary structures AS may be configured to enable automatic identification of at least one of the position of the plunger 1000 and / or the movement of the plunger 1000, for example, during testing of the device 100 including the plunger 1000. Preferably, the at least one auxiliary structure AS may be a circumferentially extending auxiliary structure that extends at least partially around the circumference of the shaft 1010, preferably at least around a quarter of the circumference of the shaft 1010. However, other types of auxiliary structures may also be used, such as axially extending structures. The group 1050a may include, from distal to proximal: a groove 1051.1a, a groove 1051.2a, and a groove 1051.3a. The group 1050b may include, from distal to proximal: a groove 1051.1b, a groove 1051.2b, and a groove 1051.3b.

[0544] In addition to the testing function, the grooves 1051.1a, etc. may also have several functions, such as the visual feedback function described later.

[0545] A method for batch testing a drug delivery device 100, the drug delivery device including a plunger 1000 or any other plunger including a suitable auxiliary structure AS, the method may include:

[0546] - Preferably using at least one injection molding die to produce a batch of plungers 1000 and / or drug delivery devices 100,

[0547] - Assembling the drug delivery device 100,

[0548] - Testing the drug delivery device 100, wherein the testing may include using a camera (such as a high-speed camera and / or using a shutter) to preferably automatically detect the auxiliary structure AS and identify the position of the plunger 1000 during and / or at the end of the dose (drug Dr, M) discharge,

[0549] - Performing quality control based on at least one result of the testing.

[0550] A batch may include several parts produced using the same machine / die and / or cavity, etc. A batch may include a plurality of parts in the range of 10 to 1000, or in the range of 100 to 500.

[0551] The quality control may be statistical quality control, such as defining how many devices must be tested during production to ensure quality, for example, when to test and how many devices must be tested preferably according to an approved test plan.

[0552] Preferably, the auxiliary structure AS (such as the grooves 1051a, 1051.2a, etc.) is arranged at an angular position of the shaft 1010 such that the auxiliary structure AS can be observed through at least one sidewall window 710 of the drug delivery device 100. However, other arrangements are also possible, for example if appropriate radiation is used to identify the position / movement of the plunger, such as radiation passing through the housing or body 700.

[0553] Optionally, the plunger 1000 may include at least one lateral opening 1052.1a, 1053 or preferably at least two lateral openings 1052.1a, 1052.1b on opposite lateral sides of the shaft 1010. The at least one lateral opening 1052.1a, 1053 or the at least two lateral openings 1052.1a, 1052.1b may be configured to allow removal of at least one auxiliary part of the mold for producing the plunger 1000. The at least one auxiliary molding part may be configured to laterally hold an additional auxiliary molding part that is elongate during injection of plastic into the mold, the additional auxiliary molding part such as including a rod or pin or consisting of a rod or pin. The additional auxiliary molding part (such as a rod or pin) may be an elongate part that may define or at least partially define the internal profile of the internal elongate cavity 1059 of the plunger 1000. The internal profile / cavity 1059 of the plunger 1000 may include an internal elongate cavity hole, especially a generally cylindrical hole, preferably including a slight draft angle that may facilitate removal of the additional auxiliary molding part (such as a rod or pin) after injection of the plastic material into the mold and after an appropriate cooling time.

[0554] According to a second embodiment, two pairs of molding grooves 1052a, 1052b may be used. One pair 1052a may include grooves 1052.1a and 1052.2a. One pair 1052b may include grooves 1052.1b and 1052.2b. However, it is also possible to use only one of the two pairs of molding grooves 1052a, 1052b or only one groove on each lateral side of the plunger 1000, such as only two molding grooves in total. Thus, it is possible to use only grooves 1052.1a and 1052.1b or only grooves 1052.2a and 1052.2b. The grooves 1052.2a and 1052.2b are described in more detail below, see Figure 10L and the corresponding description.

[0555] Preferably, the lateral openings 1052.1a, etc., 1053 are arranged at an angular position of the shaft 1010 to prevent the lateral openings 1052.1a, etc., 1053 from being seen in at least one sidewall window 710 (drug viewing window) of the drug delivery device 100. However, other positions are also possible, see Figure 10J, the opening 1053 is at the top surface of the shaft 1010, for example, at the same angular position as the middle of the upper auxiliary structures AS, 1050a, 1051.1a, etc.

[0556] A method for producing the plunger 1000 or any other plunger may include:

[0557] - Preparing a mold for producing at least one plunger 1000 or a plurality of plungers 1000, wherein the mold includes two main parts that are configured to be pressed together during molding, and wherein the two main parts define the outer contour of at least one of the plungers 1000. The inner contour of the inner elongated cavity 1059 of the plunger 1000 may be defined by an elongated first auxiliary molding part (for example, including a rod or a pin or consisting of a rod or a pin), which is preferably arranged on a first slider that is part of the mold. The mold may include at least one second auxiliary molding part that is configured to laterally hold the elongated first auxiliary molding part (such as a pin or a rod) during injection of the plastic material 1090 into the mold, preferably at the free end and / or the middle part of the elongated first auxiliary molding part. At least one second auxiliary molding part may preferably be integrally arranged on the mold, that is, a separate slider may not be used here, but alternatively, a second slider may be used here. However, each slider may make the mold more complex and thus the production more complex.

[0558] - Closing the two main parts of the mold before, during, or after sliding the first slider (and optionally the second slider (if any)) to its molding position, whereby at least one second auxiliary molding part laterally holds the first auxiliary molding part (such as a rod or a pin).

[0559] - Injecting the plastic material 1090 into the mold, whereby at least one plunger 1000 is formed, wherein the plunger 1000 includes at least one molding groove 1052a, 1052b, 1052.1, etc. or at least one other molding opening 1053 at the position defined by at least one second auxiliary molding part.

[0560] - Optionally, performing cooling, for example, by forced cooling using a liquid cooling medium in the cooling cavity of the mold, or free cooling (such as without using a separate cooling medium other than ambient air), preferably mainly using or only using heat conduction within the mold.

[0561] - Opening the two main parts of the mold and sliding the first slider (and the second slider (if any)) back to a position that allows at least one plunger 1000 to be ejected from the mold.

[0562] - Ejecting at least one plunger 1000 from the mold after opening the two main parts.

[0563] Due to the use of a second auxiliary forming part that holds the first auxiliary forming part (such as a rod or a pin), especially at its free end, the accuracy of the plunger 1000 can be relatively high, for example, in order to prevent displacement during the injection of the thermoplastic material 1090 into the mold under high pressure.

[0564] Optionally, the plunger 1000 or any other plunger may include at least one holding structure 1043, 1040.1, preferably a rib 1040.1. The at least one holding structure includes a proximal axially extending portion 1045 and a distal support portion 1044. The distal support portion has a greater angular width relative to the width of the axially extending portion 1045. The holding structure 1043 may be configured to interact with an additional holding structure 1221.1 (a shaped groove) on a part of the drug delivery device 100 such that the plunger 1000 is firmly held within the additional holding structure 1221.1 (the shaped groove) in the state where it is biased by the drive spring 1100. Preferably, the axial length of the axially extending portion 1045 is greater than the axial length of the distal support portion 1045, for example, 2 times greater or 3 times greater, preferably less than 10 times.

[0565] Optionally, the plunger 1000 may include the above-mentioned trigger feature TF. The trigger feature TF may comprise or may include at least one set 1042a, 1042b, for example, at least one pair including at least two outwardly pointing ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b of pairs 1042a, 1042b. A pair 1042a may include ribs 1040.2a and 1040.3a. A pair 1042b may include ribs 1040.2b and 1040.3b.

[0566] The corresponding ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b in at least one set (such as a pair) 1042a, 1042b may be located at the same angular position or have an angular offset of less than 10 degrees relative to each other. The corresponding ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b in at least one set 1042a, 1042b may have different axial positions, preferably spaced less than 15 mm or less than 10 mm apart. The corresponding ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b may also extend in the axial direction. The corresponding ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b may have an angular or circumferential extension that is small compared to their radial and / or axial extensions.

[0567] At least two outwardly directed ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b in at least one of the groups 1042a, 1042b can be arranged on corresponding common ribs CR, CRa, CRb, which can extend axially relative to the longitudinal axis of the shaft 1010.

[0568] Preferably, at least one support rib SR can be arranged on the corresponding common ribs CR, CRa, CRb. The support rib SR can extend axially and extend obliquely relative to at least two outwardly directed ribs 1040.2, 1040.2a, 1040.2b; 1040.3, 1040.3a, 1040.3b in at least two adjacent groups of the at least two groups 1042a, 1042b, preferably at an angle in the range of 80 degrees to 100 degrees, such as about 90 degrees or 90 degrees, with the ribs 1040.3a and / or 1040.3b arranged on the more proximal side P.

[0569] Preferably, at least one support rib SR can include a rounded support feature RF, which includes a curved shape, wherein the curve extends from an axial position equal to the proximal axial position of the first rib (such as the distal rib (such as 1040.2a, 1040.2b)) in at least one of the groups 1042a, 1042b to an axial position equal to the proximal axial position of the second rib (such as the proximal rib (such as 1040.3a, 1040.3b)) in the corresponding group of the at least one of the groups 1042a, 1042b.

[0570] The following radially extending ribs can be used, for example, for reinforcement purposes:

[0571] - Rib 1046, which is at the distal end of the common ribs CR, CRa, CRb and preferably terminates at the distal part of the ribs 1040.2a, 1040.2b.

[0572] - Rib 1047, which is at the middle part of the common ribs CR, CRa, CRb and preferably terminates at the proximal part of the ribs 1040.2a, 1040.2b; the rounded support feature RF can start from here.

[0573] - Rib 1048, which is on the side of the common ribs CR, CRa, CRb opposite to the side where the ribs 1046 and 1047 are arranged and preferably terminates at the distal part of the angled ribs 1040.3a, 1040.3b, and

[0574] - Rib 1049, which is on the side of the common ribs CR, CRa, CRb opposite to the side where ribs 1046 and 1047 are arranged, and preferably terminates at the proximal part of the angled ribs 1040.3a, 1040.3b; the rounded support feature RF can end here.

[0575] Corresponding ribs can be used on a pair 1042b including plunger ribs 1040.2b and 1040.3b. Generally, the rotational symmetry of the plunger 1000 can be preferred for ease of production (e.g., less warping during molding) and / or assembly (e.g., no additional specific features regarding the installation direction).

[0576] Optionally, the plunger 1000 can include a glass-filled or glass fiber-filled plastic material 1090, preferably a glass-filled or glass fiber-filled polyamide, more preferably a glass-filled polyamide PA 66, or can be made of or constituted by it. The content of glass or glass fiber in the glass-filled material can be in the range of 23 mass percentage to 43 mass percentage, or in the range of 30 mass percentage to 36 mass percentage, for example 33 mass percentage. Preferably, Zytel FGFE5171 from DuPont, especially FGFE5171NC010C, which contains 33 mass percentage of glass or glass fiber, can be used. Alternatively, volume percentage can be used instead of mass percentage in the above ranges or values. Other materials can also be used, such as polyamide (PA, nylon) 6. Polyamide (PA, nylon) 66 can be particularly well-suited as a material for medical devices, especially for the plunger 1000 as part of a medical device 100, because it is also suitable for the food industry. In addition, the molding properties are excellent.

[0577] Optionally, the plunger 1000 can include at least one axially extending cut (e.g., groove) 1020a, 1022a, 1020b, 1022b or at least two longitudinal cuts (e.g., grooves) 1020a, 1020b. At least one axially extending cut 1020a, 1020b or at least two longitudinal cuts 1020a, 1022a, 1020b, 1022b can be arranged within the proximal part of the shaft 1010. Preferably, at least one axially extending cut 1020a, 1022a, 1020b, 1022b or at least two longitudinal cuts 1020a, 1022a, 1020b, 1022b can be configured to interact with the support arm 1241, as explained in more detail below, for example see Figures 13B to 13E and the corresponding description. In particular, the support arm (e.g., support arm 1241) can be configured to interact with and / or trigger the auditory indicator and / or indicator 1300 of the drug delivery device 100, see for example Figure 13Aand corresponding descriptions.

[0578] Pairs of incisions may be used. A first pair may include incisions 1020a, 1022a. A second pair may include incisions 1020b, 1022b. If only one acoustic indicator and / or indicator 1300 is used, only one pair may be used to trigger the acoustic indicator and / or indicator 1300. The other pair may be absent or may be present, for example in order to give the plunger 1000, in particular the shaft 1010, rotational symmetry. Alternatively, only one inwardly directed rib may be used on or in the flexibly supported arm 1241. In this case, only one incision may be used to interact with the single radially inwardly directed rib on the support arm 1241. Additional incisions may be arranged on the other side of the shaft 1010. Alternatively, only one incision is used.

[0579] The incisions 1020a, 1020b, 1022a, 1022b may be longitudinally extending incisions (slots). The slope of the side of the first incision in a pair may be different from the slope of the side of the second incision in the pair, for example in order to avoid using a slider.

[0580] The above features on the plunger 1000 may achieve multiple functions. Thus, the plunger 1000 may be a multi-functional part of the drug delivery device 100, especially if all functions are achieved. The combination of these functions may have a synergistic technical effect, especially if the additional functions described below with reference to Figures 10K to 10M are considered.

[0581] Figure 10K A distal view of the plunger 1000 according to a second embodiment is shown. The plunger 1000 may include at least one identification mark 1080, which preferably includes at least one letter, at least one number and / or at least one other symbol on the plunger 1000, preferably on the shaft 1010, more preferably on the distally facing surface 1014 of the shaft 1010.

[0582] The plunger 1000 may include at least two, at least three or at least four identification marks 1080.1 to 1080.4 on the distally facing surface 1014 of the shaft 1010, preferably on the outer side bounded by the distal end of the shaft 1010 and on the inner side bounded by the proximal part of the end portion 1012 of the plunger 1000.

[0583] In this embodiment, four markers 1080.1 to 1080.4 are arranged on the annular surface 1016. The four markers 1080.1 to 1080.4 may have an equidistant spacing between markers that are angularly adjacent to each other. The identifier "600X" may be indicated by the markers 1080.1 to 1080.4, for example in order to indicate a particular mold and / or a particular set of molds (e.g., all parts for the drug delivery device 100) and / or a particular cavity within the mold. By way of example only, the value of the identifier "600X" may indicate that the part was produced using the sixth cavity.

[0584] At least one additional marker 1082 may be arranged on other parts, such as on the drive spring holder 1200, in particular on the base 1202 of the drive spring holder 1200. The same value of the marker or the same marker may be used on several parts of the same drug delivery device 100, thereby indicating the dedicated cavity and / or mold used for producing each part of the drug delivery device 100, see for example the marker "600X". Thus, it is possible to select only parts that are, for example, produced in the sixth cavity of a mold in a dedicated set of molds. Alternatively, as another example, the plunger 1000 produced in the first cavity of a plurality of cavities used for producing the plunger 1000 can always be assembled with the drive spring holder 1200 produced in the second cavity of a plurality of cavities used for producing the drive spring holder 1200.

[0585] Compared to a random combination of parts within, for example, one drug delivery device, the use of markers enables better control of production, for example enabling better statistical control. A particular mold can be used for a particular part, for example one mold is only used for the plunger and another mold is only used for other parts. Alternatively, different types of parts can be produced within one mold, such as the plunger 1000 and the drive spring holder 1200 or other parts of the drug delivery device.

[0586] A method for marking a plunger (such as the plunger 1000) may include:

[0587] - Preparing a mold for producing at least one plunger 1000 or a plurality of plungers 1000, wherein the mold may include at least one cavity for producing at least one plunger 1000 or corresponding cavities for producing a plurality of plungers 1000,

[0588] - Marking at least one cavity by using at least one of a groove or a protrusion to print at least one letter, digit or other symbol onto at least one plunger or each of a plurality of plungers, preferably using different markings 1080.1 to 1080.4 for different cavities, wherein preferably at least a portion of the markings 1080.1 to 1080.4 indicates or is an identifier of the mold and / or cavity, or wherein at least one marking includes an identifier of the mold and / or cavity of the mold.

[0589] - Using the mold to produce at least one plunger 1000, and

[0590] - For at least one of the produced plungers 1000, preferably tracing the mold and / or cavity used to produce the plunger 1000, for example as part of a quality control method, preferably involving storing digital data related to the marking or marker, for example.

[0591] Replaceable inserts can be used to facilitate the manufacture of the mold and the marker and / or to be able to change the marker in a simple manner when necessary or omit the marker when appropriate.

[0592] A similar method can be used to mark parts of a device (any mechanically operated device, housing, etc.), especially parts of a drug delivery device 100, and the method includes:

[0593] - Preparing at least two molds for producing at least two different parts (preferably including a plunger 1000) of a drug delivery device 100, wherein the corresponding mold can include at least one cavity for producing the corresponding at least one part.

[0594] - Marking at least one cavity by using at least one of a groove and a protrusion to print at least one letter, digit or other symbol onto at least one part, preferably using different markings 1080.1, 1080.4 for different cavities and / or different markings 1080.1, 1080.4 for different molds, wherein preferably at least a portion of the corresponding markings 1080.1, 1080.4 can indicate or can be an identifier of the mold, or wherein at least one marking can include an identifier of the mold and / or cavity of the mold.

[0595] - Using these molds to produce at least one drug delivery device 100.

[0596] - Assembling the drug delivery device 100, and

[0597] - For at least one of the produced devices 100, preferably trace the mold and / or cavity used to produce the device 100, for example as part of a quality control method, thereby preferably storing digital data related to a mark or marker.

[0598] In Figure 10K a preferred tool parting plane TPP is shown, i.e., the plane where the two halves of the mold can physically contact each other. However, other arrangements of the TPP are also possible. The injection point can be arranged on the distal surface 1014 of the plunger tip portion 1012 or at any other suitable position on the plunger 1000.

[0599] In an alternative embodiment, for example if the injection point is not arranged on the distal surface 1014, additional marks can be arranged on the distal surface 1014 of the plunger tip 1012. According to another embodiment, at least one mark can be arranged on the distal surface of the plunger tip 1012 but not on the annular surface 1016.

[0600] Figure 10L A cross-section of the shaft 1010 of the plunger 1000 along the radial direction RD according to a second embodiment is shown. In Figure 10L the circumferential direction CD is also shown.

[0601] Furthermore, optionally, as described above, the interaction feature IF can be constituted by or can include the elongated cavity 1059 within the shaft 1010. The elongated cavity 1059 can be configured to interact with the drive spring 1100, preferably with a compression spring. In addition, the elongated cavity 1059 can be configured to hold the spring support arm / pin 1230, for example see Figure 12A .

[0602] The plunger 1000 can include at least two or at least three or at least four internal ribs 1060.1 to 1060.4, which extend at least a quarter, a half, three-quarters of the axial length of the elongated cavity 1059, or along the entire axial length of the elongated cavity. At least two ribs 1060.1 to 1060.4 can be arranged at equidistant angular positions of adjacent ribs 1060.1 to 1060.4. In the shown embodiment, four internal ribs 1060.1 to 1060.4 are arranged on the inner side of the shaft 1010. The proximal end of the rib 1060.1 can be arranged between the cutout 1020a and the cutout 1020b or at another suitable position. The proximal end of the rib 1060.3 can be arranged between the cutout 1022a and the cutout 1022b or at another suitable position. All internal ribs can form a group of 1060 internal ribs.

[0603] The lateral opening 1052.2a can include:

[0604] - The extremely inclined surface 1055,

[0605] - The surface 1056 that is moderately inclined with respect to the inclination angle of the inclined surface 1055,

[0606] - The side surface 1057 ( Figure 10L not shown in, see for example Figure 10J ), and

[0607] - The side surface 1058.

[0608] The radial direction RD can be used to define the inclination angles of the inclined surfaces 1055 and 1056, thereby using the radial direction at the inner boundaries or edges of the corresponding inclined surfaces 1055 and 1056.

[0609] The arrangement of the surfaces 1055 and 1056 can allow the use of die parts to form the lateral opening 1052.2a without additional sliders, as is obvious considering the tool (die) parting surface TPP in Figure 10L For example, in terms of the tool closing direction and the tool opening direction (perpendicular to the tool (die) parting surface TPP), neither of the surfaces 1055 and 1056 will produce an undercut structure during manufacturing. This is possible even if the corresponding die parts have rounded features that interact with the die pins or die rods used to define or form the internal cavity 1059. This also applies to the side surfaces 1057 and 1058. However, for example, if the tool (die) parting surface TPP is arranged at another position, the use of additional sliders is also possible.

[0610] Preferably, all other lateral openings, such as 1052.1a, 1052.1b, 1052.2b, can include the same features as those of the lateral opening 1052.2a.

[0611] Figure 10M A cross-section of the shaft 1010 of the plunger 1000 along the longitudinal direction is shown.

[0612] The plunger 1000 (such as the shaft 1010) can include at least one or all of the following features in the cross-section from the proximal end 1011p to the distal end 1011d, preferably in a given order, especially on the inner side of the shaft 1010:

[0613] - Preferably, the first rounded edge 1074,

[0614] - The inclined surface 1075, preferably inclined with respect to the outer surface 1071 of the shaft 1010 and / or with respect to the inner main surface 1077,

[0615] - Preferably, the second rounded edge 1076, and / or

[0616] - The plunger 1000, and more specifically, the inner surface 1077 of the shaft 1010.

[0617] In particular, the inclined surface 1075 may have a significant influence on the generation of the noise sound wave components generated during the release of the drive spring 1100. The inclined angle of the inclined surface 1075 relative to the longitudinal axis or relative to the outer surface 1071 may be in the range of 30 degrees to 60 degrees, so as to generate noise including a small amount of noise components, thereby making it easy for the user to accept.

[0618] In addition, the following features are shown:

[0619] - The outer surface 1071 of the shaft 1010,

[0620] - The outer edge 1072 of the shaft 1010, and

[0621] - The proximal surface 1073 pointing proximally.

[0622] Additionally or alternatively, the radii of the first rounded edge 1074 and the second rounded edge 1076 may have an impact on noise generation. Therefore, a smaller curvature, such as a larger radius, may be used on the edge 1074 and / or the edge 1076, preferably relative to the radii on other edges of the shaft 1010 (such as on the edge 1072 and / or on the edge 1074).

[0623] The drug delivery device 100 may include:

[0624] - The plunger 1000 according to any one of the foregoing embodiments, and

[0625] - A drug container, in particular a pre-filled syringe 900, or a holding space configured to hold a drug container (such as the syringe 900), wherein the drug container (900) may store a drug (Dr, M) or may be configured to store a drug (Dr, M).

[0626] The rear sub-assembly (RSA) (see, for example Figure 13I ) may include:

[0627] - A drive spring holder (1200) configured to hold the drive spring (1100),

[0628] - The drive spring (1100), and

[0629] - The plunger (1000) according to any one of the above embodiments.

[0630] Therefore, the above effects can also be applicable to the drug delivery device 100 or the rear sub-assembly (RSA).

[0631] The plunger 1000 according to the first embodiment (see, for example, Figure 10 ) and the plunger 1000 according to the second embodiment do not include threads. Therefore, its production is not as complex as that of a plunger including at least one thread or also including reverse threads.

[0632] 11. Driving spring ( Figures 11A to 11C )

[0633] Figure 11A The driving spring 1100 is shown. The driving spring 1100 can be configured to provide a driving force to the plunger 1000 when, for example, the first plunger boss 1040.1 of the plunger 1000 disengages from the profiled groove 1221.1 of the driving spring holder 1200 as described in Sections 10 and 12, so as to move the plunger 1000 in the distal direction relative to the syringe barrel 900 (not shown).

[0634] The spring mechanism can provide a force for emptying the syringe barrel 900. In particular, the spring mechanism can include a driving spring 1100, which can interact with the plunger 1000 and can move the plunger 1000 distally relative to the device body 700 and / or relative to the driving spring holder 1200 and / or relative to the syringe barrel 900. When the plunger 1000 contacts the stopper 910, this can cause the plunger stopper 910 to move distally within the syringe barrel 900. Thus, the drug can be discharged from the barrel 902 of the syringe barrel 900. In other words, the driving spring 1100 can provide a force for drug discharge and injection.

[0635] As Figure 11B and Figure 11C shown, the driving spring 1100 can surround the driving spring support arm / pin 1230 of the driving spring holder 1200 and can extend in the distal direction D from the base 1201 of the driving spring holder 1200. The distal end of the driving spring 1100 can abut against the proximally facing inner surface of the plunger 1000. In other words, the driving spring 1100 can be configured to extend inside the plunger 1000.

[0636] The driving spring support arm / pin 1230 can have a substantially circular cross-section or a circular cross-section. Preferably, at least two longitudinal guiding ribs can be arranged along the outer surface of the driving spring support arm / pin 1230. The longitudinal guiding ribs can be configured to support the driving spring 1100 against radially inward movement. There can be at least two ribs, at least three ribs or at least four ribs, preferably arranged equidistantly along the circumference of the driving spring support arm / pin 1230.

[0637] Inside the plunger 1000, the drive spring 1100 can be guided by at least one internal rib of the plunger 1000, which is formed at the inner surface of the plunger shaft 1010 and extends in the axial / longitudinal direction of the plunger 1000. In one embodiment, the drive spring 1100 can be guided inside the plunger 1000 by at least four of said internal ribs. The internal ribs can be arranged equidistantly around the inner circumference of the plunger shaft 1010. The internal ribs can extend along at least a part of the axial length of the plunger shaft 1010, preferably along the entire axial length of the plunger shaft 1010. Alternatively, there can be different angular offsets between the internal ribs. In one embodiment, the internal ribs can extend from the bevel 1075 of the plunger 1000 to the inner distal face of the plunger 1000. Further details are described, for example, in Section 10.

[0638] In one embodiment, the drive spring 1100 can be made of high-strength stainless steel. For example, the drive spring 1100 can be made of austenitic steel with sufficient elasticity to allow elastic compression of the drive spring 1100. In one embodiment, the drive spring 1100 can be made of austenitic chromium-nickel steel. In one embodiment, the drive spring 1100 can be made of DIN EN1.4310 steel.

[0639] In one embodiment, the drive spring 1100 can be made of coiled wire. The wire diameter can be selected according to the stress borne when the drive spring 1100 is compressed (e.g., fully compressed before the drug delivery device 100 is activated). In one embodiment, the wire can be soap-lubricated wire to facilitate manufacturability.

[0640] In one embodiment, the drive spring 1100 can have 10 to 150 turns or coils. In one embodiment, the drive spring 1100 can have 20 to 120 turns or coils. In one embodiment, the drive spring 1100 can have 40 to 100 turns or coils, such as 80 turns or coils.

[0641] The coil diameter can be selected according to the geometry of the plunger 1000 and the drive spring support arm / pin 1230 of the drive spring holder 1200.

[0642] In one embodiment, the inner diameter (inner diameter of the coil) of the drive spring 1100 can be between 1.5 millimeters (mm) and 6 mm, preferably between 2.0 mm and 4.0 mm, such as 2.5 mm.

[0643] In one embodiment, the outer diameter (outer diameter of the coil) of the drive spring 1100 can be between 2.0 mm and 8.0 mm, preferably between 3.0 mm and 6.0 mm, such as 4.0 mm.

[0644] The length of the drive spring 1100 and / or the wire diameter and / or the number of turns of the wire forming the drive spring 1100 can be selected such that the drive spring provides a smooth force curve while allowing for simple and straightforward assembly. In other words, the specific characteristics of the drive spring 1100 can be adapted to minimize the impact load at the start of injection and / or to minimize the force on the support device components during storage.

[0645] Furthermore, the specific characteristics of the drive spring 1100 can be adapted such that the drive spring 1100 provides sufficient activation force to meet the injection time requirements. Such requirements can be that the syringe barrel 900 can be emptied in less than 30 seconds, preferably in less than 20 seconds. In one embodiment, the preferred injection time requirement can be less than 15 seconds. Additionally, the specific characteristics of the drive spring 1100 can be selected according to the force requirements, such as the maximum actuation force that can be applied to the plunger.

[0646] In one embodiment, in the unbiased state, the length of the drive spring 1100 can be between 50 mm and 200 mm, preferably between 100 mm and 200 mm, for example 110 mm.

[0647] In one embodiment, the drive spring 1100 can be configured to provide an actuation force between 2 N (Newtons) and 60 N depending on its compressed state. In one embodiment, the drive spring 1100 can be configured to provide an actuation force between 3 N and 50 N, preferably between 3 N and 40 N, depending on its compressed state. In one embodiment, the drive spring 1100 can be configured to provide an actuation force between 3 N and 24 N depending on its compressed state.

[0648] 12. Drive spring holder ( Figures 12A to 12G )

[0649] Figure 12A and Figure 12B shows a drive spring holder 1200. The drive spring holder 1200 can be configured to support the drive spring 1100 and the plunger 1000 relative to the device body 700. The drive spring holder 1200 can be configured to withstand the load of the drive spring 1100 before the plunger 1000 is actuated, for example during the storage of the rear sub-assembly (RSA). The drive spring holder 1200 can further be configured to compensate for changes in the length of the syringe barrel 900 and to prevent the syringe barrel 900 from moving proximally within the drug delivery device 100. The drive spring holder 1200 can further be configured to support an auditory indicator and / or a tactile indicator, such as the rattle 1300 (not shown) described below.

[0650] The drive spring holder 1200 may have a base 1201 at its proximal end that defines a proximal surface 1201.1 which, in the assembled state of the drug delivery device 100, may define the proximal (rear) end surface of the drug delivery device 100.

[0651] The drive spring holder 1200 may further include one or more syringe support arms 1202 that extend from the base 1201 in a distal direction (opposite to the proximal direction indicated by arrow P). When the drive spring holder 1200 is assembled with the device body 700, the syringe support arms 1202 may be arranged radially inside the device body 700. The syringe support arms 1202 may be rigid so as not to deform due to the forces experienced during the assembly, use or accidental dropping of the drug delivery device 100.

[0652] The diameter of the base 1201 may be similar to or larger than the outer diameter of the proximal end of the device body 700 such that the base 1201 of the drive spring holder 1200 cannot move distally inside the device body 700. In other words, when the drive spring holder 1200 moves distally within the device body 700, the base 1201 of the drive spring holder 1200 may abut against the edge 732 of the proximal orifice 730 of the device body 700.

[0653] The drive spring holder 1200 may further include a housing lock formed by one or more deflectable latch arms 1203. The latch arms 1203 may be located at the proximal end of the drive spring holder 1200, distal to the base 1201. As Figure 12DAs shown, the latching arm 1203 may include a flexible portion 1203.1 that extends in the axial direction (e.g., proximally) of the drug delivery device 100. Alternatively, the flexible portion 1203.1 may extend in both axial and radial directions such that the flexible portion 1203.1 may be radially outwardly inclined in the proximal direction. The housing latching arm 1203 may further include a latching protrusion 1203.2 that protrudes radially outwardly from the flexible portion 1203.1. The latching arm 1203 may be pre-tensioned, i.e., outwardly biased, such that during assembly of the drive spring holder 1200 in the device body 700 (not shown), when the drive spring holder 1200 is moved distally in the device body 700, the latching arm 1203 is first deflected inwardly and tensioned due to contact with the inner surface of the device body 700. When aligned with the proximal notch 714 of the device body 700, the latching arm 1203 returns to its relaxed state, thereby moving the latching protrusion 1203.2 radially outwardly to engage or latch into the proximal notch 714, thus firmly fastening the drive spring holder 1200 to the device body 700 in the first drive spring holder position (closed position). In other words, the latching arm 1203 may be configured to form a snap-fit connection with the notch 714. In the first drive spring holder position, axial movement of the drive spring holder 1200 relative to the device body 700 may be restricted / prevented due to the interaction between the latching protrusion 1203.2 and the proximal notch 714. Further, in the first drive spring holder position, rotational movement of the drive spring holder 120 relative to the device body 700 may be restricted / prevented.

[0654] The drive spring holder 1200 may further include a drive spring support arm / pin 1230 (see Figures 12A to 12C ). The central longitudinal axis of the drive spring support pin 1230 may coincide with the central longitudinal axis of the drive spring holder 1200. The drive spring support pin 1230 may be configured to support the drive spring 1100 and the plunger 1000 in the radial direction. In other words, the drive spring support pin 1230 may center the drive spring 1100 and / or the plunger 1000 relative to the drive spring holder 1200 during assembly and before the drug delivery device 100 is activated. For example, at least two, at least three, or at least four longitudinal ribs may be arranged on the outer surface of the drive spring support pin 1230. The longitudinal ribs may be arranged equidistantly in the circumferential direction. The longitudinal ribs may support the drive spring 1100 and / or the plunger 1000 against radially inward movement relative to the drive spring support pin 1230.

[0655] After activation (or triggering) of the drug delivery device 100, i.e., when the plunger 1000 disengages from the profiled groove 1221.1 of the drive spring holder 1200 as explained in section 10 above, the drive spring support arm / pin 1230 can be configured to guide the axial movement of the drive spring 1100 and the plunger 1000. The arm / pin 1230 can extend from the base 1201 along at least a portion of the axial length of the drive spring holder 1200 (e.g., along at least 50% or at least 70% of the axial length of the drive spring holder 1200).

[0656] In one embodiment, the drive spring support arm / pin 1230 can have a cylindrical shape in the axial direction. Alternatively or additionally, the drive spring support arm / pin 1230 can have a conical shape in the axial direction. In particular, the outer diameter of the pin 1230 can decrease in the distal direction, e.g., to allow demolding from the mold.

[0657] In one embodiment, the drive spring support arm / pin 1230 can be configured to guide the drive spring 1100 and / or the plunger 1000 during assembly and / or during use (i.e., during release of the drive spring 1100).

[0658] In one embodiment, the profiled groove 1221.1 can be formed at the proximal end of at least one syringe support arm 1202, distal to the base 1201. The profiled groove 1221.1 can be formed circumferentially close to at least one of the latching arms 1203 (see Figure 12A and Figure 12B ). Thus, the profiled groove 1221.1 and the latching arms 1203 can at least partially overlap in the axial direction. The profiled groove 1221.1 can be configured to interact with the plunger 1000 when the plunger is connected to the drive spring holder, as described in this disclosure.

[0659] The drive spring holder 1200 can include longitudinal ribs 1236, as Figure 12A and Figure 12B shown, for interacting with the plunger 1000, as described in section 10 above.

[0660] As Figure 12A and Figure 12B shown, the drive spring holder 1200 can further include a rattle support structure 1240. The rattle support structure 1240 can be arranged on at least one of the syringe support arms 1202. The rattle support structure 1240 can be arranged to be offset distally relative to the profiled groove 1221.1. The rattle support structure 1240 can define a recess into which a rattle 1300 (not shown) can be inserted, as described below, e.g., in section 13.

[0661] In one embodiment, the flapper support structure 1240 may include a flapper support arm 1241, at least one flapper protrusion restraint 1242, and a flapper rear support 1243 (see Figure 12A and Figure 12B ).

[0662] In one embodiment, the flapper support structure 1240 may further include at least one flapper mounting groove 1244.

[0663] The flapper support structure 1240 is configured to support the flapper 1300, and when the plunger 1000 overlaps the flapper support arm 1241 and the drive spring support arm 1230 in the axial direction, the flapper support structure may support the flapper 1300 in a radially outward direction.

[0664] The flapper support arm 1241 may be flexible and / or resilient (elastic) and / or deflectable and / or movable, preferably in a substantially radial direction of the drive spring holder 1200. The flapper support arm 1241 may be disposed at the distal end of the flapper support structure 1240, distal to the flapper rear support 1243 and the flapper protrusion restraint 1242.

[0665] The flapper support arm 1241 may include at least one outwardly directed ramped protrusion 1241.1. The outwardly directed ramped protrusion 1241.1 may extend radially outward from the radially facing outer surface of the syringe support arm 1202. The ram...

Claims

1. A device body (700) for a drug delivery device (100), the device body comprising: a needle shield positioning structure (720, 724) configured to fasten a needle shield (500) against axial movement relative to the device body (700) by interacting with at least one corresponding fastening feature (505, 510) of the needle shield (500) when the needle shield (500) of the drug delivery device is in a needle shield position (Z) relative to the device body (700), wherein the device body (700) has a proximal end and a distal end; wherein, in the needle shield position (Z), the needle shield (500) projects distally beyond the device body (700); wherein the device body (700) further comprises a first needle shield safety structure (720.1) configured and arranged to prevent separation of the fastening feature (505, 510) from the needle shield positioning structure (720, 724) by interacting with an outer surface of the needle shield (500) when a portion of the device body (700) having the needle shield positioning structure (720, 724) is deformed.

2. The device body (700) according to claim 1, wherein, the first needle shield safety structure (720.1) is a protrusion extending radially inwards from an inner surface of the device body (700).

3. The device body (700) according to claim 2, wherein, a radially inwards extension amount of the protrusion decreases in a proximal direction (P) along an axial extension amount of the protrusion.

4. The device body (700) according to any one of the preceding claims, wherein, the first needle shield safety structure (720.1) extends axially, e.g., in a proximal direction (P), from a proximal end of the needle shield positioning structure (720, 724).

5. The device body (700) according to any one of the preceding claims, wherein, the portion of the device body (700) is a distal portion of the device body (700).

6. The device body (700) according to any one of the preceding claims, wherein, the first needle shield safety structure (720.1) is configured to restrict radial movement of an outer surface of the needle shield (500) relative to an inner surface of the device body (700).

7. The device body (700) according to any one of the preceding claims, wherein, the needle shield positioning structure (720, 724) comprises at least one, preferably at least four, ribs extending radially inwards from an inner surface, e.g., a side wall, of the device body (700).

8. The device body (700) according to any one of the preceding claims, further comprising at least one proximal stop structure (721) that defines a maximum proximal position of the needle shield (500) relative to the device body (700) by interacting with a rear stop feature of the needle shield (500) when the needle shield (500) moves proximally relative to the device body (700).

9. The device body (700) as claimed in any one of the preceding claims, further comprising a central support structure (701) configured to support a drug container (900), such as a pre-filled syringe (900) and / or a container holder (800), such as a syringe holder (800).

10. The device body (700) as claimed in claim 9, wherein, the central support structure (701) is connected to the side wall of the device body (700) via at least one, preferably four connecting elements (708), such as connecting ribs (708), and wherein the connecting element (708) extends along at least 50% of the axial length of the central support structure (701).

11. The device body (700) as claimed in claim 10, wherein, the radially inward portion of the connecting element (708) is shorter in the axial direction than the radially outward portion of the connecting element (708), such that at least the distal surface of the radially outward portion protrudes distally beyond the distal surface of the radially inward portion.

12. The device body (700) as claimed in any one of the preceding claims, further comprising a holder guiding structure (726), such as at least one holder guiding rib (726), preferably four holder guiding ribs (726), configured to interact with a container holder (800) and / or a body closure (1200) of the drug delivery device (100) so as to restrict rotational movement of the container holder (800) and / or the body closure (1200) relative to the device body (700).

13. The device body (700) as claimed in claim 12, further comprising a needle shield anti-rotation structure (723) configured to prevent rotation of the needle shield (500) relative to the device body (700) by interacting with an anti-rotation feature of the needle shield (500).

14. The device body (700) as claimed in claim 13, wherein, the needle shield anti-rotation structure (723) includes a protrusion extending circumferentially and radially from at least one of the connecting elements (708), thereby forming an anti-rotation surface for interacting with the anti-rotation feature of the needle shield (500).

15. The device body (700) as claimed in claim 13 or 14, further comprising a second needle shield safety structure (722) configured and arranged to prevent the anti-rotation feature from disengaging from the anti-rotation structure (723) by interacting with the inner surface of the needle shield (500).

16. The device body (700) as claimed in one of the preceding claims, wherein, the needle shield position is a first needle shield position or a final needle shield position.

17. A component for a drug delivery device, the component comprising: a device body (700) as claimed in one of the preceding claims; a needle shield (500); and a needle shield spring (600).

18. A drug delivery device (100), comprising: The device body (700) according to one of claims 1 to 16 or the assembly according to claim 17; and a drug container (900) containing a drug (Dr).

19. The drug delivery device (100) according to claim 18, wherein the drug delivery device (100) is an autoinjector or a pen-type device.

20. A method of delivering a drug from a drug delivery device, the method comprising using the drug delivery device (100) according to any one of claims 18 or 19.

21. A drug for use in a method of treating a patient, wherein the method comprises using the drug delivery device (100) according to any one of claims 18 or 19 to deliver the drug to the patient.

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